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Efficacy, Self clinical trials

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NCT ID: NCT05164263 Recruiting - Safety Issues Clinical Trials

Real World Safety & Efficacy Experience of Empagliflozin With or Without Metformin in T2DM Patients - EASE Study

EASE
Start date: April 1, 2021
Phase: Phase 4
Study type: Interventional

Study Objective To evaluate the safety and tolerability of Empagliflozin with or without metformin in patients with Type II Diabetes Mellitus in the Pakistani population. Study design Open-label, prospective, observational, single arm, multi-center, post-marketing surveillance study. Sample size The estimated sample size will be n=156. Duration of study 12 months (data lock point will be completion of 6 months' follow-up from the time of last patient's enrollment date) Safety Assessment: Patient will be monitored for Hypoglycemia, Dehydration, Hypotension, Urinary Tract Infections, Fungal Infections, Nausea, Vomiting, Diarrhea, Abdominal Discomfort, Flatulence, Asthenia, Indigestion and Other side effects (if any). Follow up visits: After recruitment, patient is supposed to have three visits for follow-ups. Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy. LABORATORY TESTING: Reputable Lab is considered for laboratory testing of diabetes patients i.e. HbA1C%, FBG, RFT and urine R/E. The certified clinical lab will be responsible for receiving and analyzing clinical sample. Patients will have special discount of upto 50% for study related laboratory investigations. Where in Urine Routine Examination (Urine R/E), we consider as follows: - Visual Examination: - Urine color: Normal (Yellow), Pale Yellow, Dark Yellow, Brown, Red or Pink or any other. - Urine clarity: Clear, slightly Cloudy, cloudy or turbidity - Chemical Examination: - Specific gravity - pH - Bilirubin - Urobilinogen - Protein - Ketone - Leukocyte Esterase - Microscopic Examination: - Red Blood Cells: - Epithelial Cells: - Amorphous: - Pus Cells - Bacteria - Yeast - Casts - Crystals Where in Renal Function Test (RFT), we consider as follows: - Blood Urea Nitrogen (BUN): mg/dL - Serum Creatinine: mg/dL - Estimated Glomerular Filtration Rate (eGFR): mL/min/1.73 m2

NCT ID: NCT05141929 Completed - Clinical trials for Pregnancy Complications

Effect of Web-Based Education on Gestational Diabetes Mellitus and Health Management Self Efficacy

GDM
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

This randomized controlled study aimed to examine the effect of web-based education related to Gestational Diabetes Mellitus on women health management self-efficacy and maternal-fetal-neonatal results.

NCT ID: NCT04998721 Recruiting - Anxiety Clinical Trials

A Dyadic Approach to Perinatal Depression in Primary Care: Maternal Infant and Dyadic Care

MInD
Start date: November 1, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the effectiveness of a parenting intervention+usual care compared to usual care on postpartum depression and other mental health and parenting outcomes, as well as the feasibility and acceptability of the parenting intervention.

NCT ID: NCT04872686 Completed - Effect of Drug Clinical Trials

Virucidal Effect of PVP-I on COVID-19 and as Well as Safety of Its Application on Nasopharynx & Oropharynx

COVID-19
Start date: April 10, 2021
Phase: Phase 3
Study type: Interventional

The COVID-19 pandemic is the defining global health crisis of our time and the greatest challenge we have faced since World War-II.Corona virus is transmitted via respiratory droplets or aerosol, produced from sneezing or coughing of infected persons to healthy individual through mouth, nose and eye. PVP-I gargle/spray used in throat and nose are shown to have broad spectrum antimicrobial activity and may have preventive effect on SARS-CoV-2. 0.6% PVP-I oro-nasal spray phase 3 clinical trial will be conducted in three dedicated Covid-19 hospitals namely Dhaka Medical College Hospital, Kurmitola General Hospital, Kuwait-Moitree Hospital. Chemical compound of the oro-nasal spray which was developed and tested at Bangladesh Reference Institute for Chemical Measurements, for its quality control/ quality assurance, shelf life and related stability following GLP guideline. This study aims to evaluate virucidal efficacy of 0.6% PVP-I against SARS-CoV-2 along with its safe uses in oronasal mucosa of healthy and SARS-CoV-2 exposed persons. The participant will be divided into three groups: Group A 768 COVID-19 positive, moderately ill admitted patient who will receive intervention once. Group B 20 asymptomatic to mild COVID-19 patients having multiple comorbidity will receive intervention 4 times hourly and Group C 10 healthy individual who accept intervention 0.6% PVP-I oronasal spray 3-4 times interval in a day for 30 days. Placebo will be used among control group for better comparison. The chemical which will be used in this study is available inside the country and also registered to open use in Bangladesh. BRiCM ensures raw material & impurities characterization as per BP 2019, AOAC and AWWA and determination of shelf life by performing the stability studies will be conducted according to Stability Zone Iva and ICH guidelines. A written consent will be taken by concern participant and a short interview will be taken on the spot prior to intervention. Participant's medical documents will be used and swab from nasopharynx & oropharynx will be taken for performing necessary test (RT-PCR) to confirm viral presence. There is no potential risk for application of this oro-nasal spray. Even though if any adverse reaction occur while using the oro-nasal spray, necessary medical management will be carried out in the respected hospital.

NCT ID: NCT04861506 Recruiting - Safety Issues Clinical Trials

The Safety and Efficiency of Endovascular Treatment of Acute or Subacute Thromboembolic Occlusions of Lower Extremity.

Start date: January 1, 2021
Phase:
Study type: Observational

Based on the development of new tools, including drug coated balloon, paclitaxel eluting stent, interwoven stents, debulking tools, More and more acute or subacute thromboembolic occlusions of lower extremity included stage IIb were treated with endovascular procedures. Most guidelines suggests only stage I and stage IIa lesions are suitable for endovascular treatments. Therefore, a well-designed real-world study that track the safety and clinical relevant outcomes, are required to determine the optimal therapies for patients with acute or subacute thromboembolic occlusions of lower extremity.

NCT ID: NCT04690725 Active, not recruiting - Safety Issues Clinical Trials

TQB3525 for Advanced Bone Sarcomas With PI3KA Mutations or PTEN Loss

TQBSP
Start date: October 1, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The PI3K, protein kinase B (AKT), and mTOR signaling network promotes cell growth, survival, metabolism, and motility, but becomes a critical oncogenic driver under aberrant conditions that control the tumor microenvironment and angiogenesis. The PI3K-AKT-mTOR axis is the most frequently deregulated signaling pathway in primary osteosarcoma and other bone tumors. PI3Ka has high rates of 25-50% activating mutations associated with tumor formation in osteosarcoma. Other causes of pathway hyperactivation include loss of function of the tumor suppressor PTEN, gain-of-function mutations in AKT and PDK1, or upregulation of receptor tyrosine kinases. TQB3525 is an orally bioavailable, potent, dual catalytic site inhibitor of PI3Ka and PI3Kd. Tumor growth inhibition has been demonstrated in multiple xenograft osteosarcoma models with PI3K-mutant, PTEN-null cell lines. The investigators try to investigate TQB3525 in primary osteosarcoma and other bone tumors for its safety, tolerability, dose-limiting toxicities (DLT), MTD and antitumor efficacy.

NCT ID: NCT04561466 Completed - Safety Issues Clinical Trials

Trial of Befizal® 200 mg for the Treatment of Leber Hereditary Optic Neuropathy

Béfinohl
Start date: March 26, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Study of the efficiency of Béfizal® 200 mg in 14 adult patients with a LHON that occurred for less than 5 years. Patient must have certain specific mutations

NCT ID: NCT04541524 Recruiting - Glaucoma Clinical Trials

Vienna Preserflo Cohort Study

Start date: June 5, 2020
Phase:
Study type: Observational

The Vienna Preserflo Microshunt Cohort Study is an observational study with a prospective postoperative examination in all glaucoma patients who had received a Preserflo Microshunt (PMS) as standalone procedure or in combination with cataract extraction in the time period between January and November 2019 at the Department of Ophthalmology, Medical University of Vienna. It is estimated that approximately 70 patients will be included of this cohort. The cohort will be invited for a prospective postoperative examination after 12 (±5) months of follow up. This examination shall comprise best corrected visual acuity, visual field test, intraocular pressure (IOP) measurement, slit lamp examination, fundus examination (optic disc and retina), gonioscopic assessment of PMS position, anterior segment optical coherence tomography (OCT) (shunt position, anterior chamber angle assessment, limbus shape analysis), corneal pachymetry, specular microscopy of corneal endothelial cells. Additionally, retrospective information concerning IOP, medication and visual fields of all patients will be collected from the Department of Ophthalmology as well as from the referring ophthalmologists where possible. Additionally, we will perform a comparison between two groups to compare differences in outcome measures.

NCT ID: NCT04341714 Completed - Telemedicine Clinical Trials

Efficiency and Satisfaction With Telephone Consultation in Neuro-urology: Experience of the COVID-19 Pandemic

Start date: March 16, 2020
Phase:
Study type: Observational

The COVID-19 pandemic has necessitated drastic measures in order to limit the spread of SARS-CoV-2. The stay home policies for the whole population and especially for frail patients and the express instruction to deprogram non-urgent consultations and interventions limited the clinic visits in neuro-urology department. In this context, telemedicine was seen as a pragmatic solution to provide follow-up care for our neurologic patients. Due to the delay in deploying telemedicine and the cognitive impairment of some of our patients, telephone consultation has been prioritized. The COVID-19 pandemic might be an opportunity to review and refine our practices in neuro-urology. For the follow-up of selected patients, telephone consultations may be efficient and cost effective. The aim of the study is to assess the efficiency and the satisfaction with telephone consultation for the physician and the patient. The study was conducted in a neuro-urology department of a university hospital in France. During the stay-home policies for the COVID-19 pandemic, all the scheduled medical visits were converted into telephone consultation. New patients weren't included. For each teleconsultation, the physician assess the duration of the consultation, the number of tries to join the patient, the efficiency of the consultation, the difficulty to obtain relevant information due to the phone way of the consultation and the lack of physical examination. On the next days, the patient was contacted by phone and was asked a) if he was satisfied of being phoned by the physician, b) if the teleconsultation was embarrassing, c) if he had enough time of teleconsultation d) if he got all the answers to his queries, e) if he would preferred to had a physical consultation f) to assessed the global satisfaction of the teleconsultation and g) if in the future, they may considered converting some clinic visits to teleconsultations. The physician and the patient assessed whether this teleconsultation has replaced a physical visit. The usual transport mode of the patient for a clinic visit and the need to take a day off for worker patients were recorded. The primary aim was to assess the efficiency and the satisfaction of the telephone consultation. The primary outcome was the evaluation of the efficiency of the telephone consultation by the physician on a numerical 10-points scale. The secondary outcome was the evaluation of the satisfaction of the telephone consultation by the patient on a numerical 10-points scale. Four hundred teleconsultations are scheduled for five physicians.

NCT ID: NCT04301206 Completed - Pediatrics Clinical Trials

Videos and Simple Text to Empower Parents to Handle Their Sick Children

Start date: September 28, 2020
Phase: N/A
Study type: Interventional

Background: The Medical Helpline 1813 (Capital Region, Denmark) handles acute, non-life-threatening medical emergencies. Approx. 200,000 calls/year concern children (ref: Rasmussen et al), and about 30% are referred to a pediatric urgent care center. However, many of these children presents very mild symptoms, which require neither treatment nor paraclinical tests, merely parental guidance. We want to empower the parents when handling their sick children by videos and simple text accessible from their smartphone. We want the parents to handle mild symptoms at home and to know when they must contact the medical helpline 1813 or a general practitioner. We have produced 8 short videos and simple texts about the most common symptoms in sick children. The material covers about 70% of the symptoms in acute sick children. The material is developed in collaboration between pediatricians and professional movie producers and is approved by the Danish Society of Pediatrics and other relevant medical societies. Purpose: It will be studied if the new material about symptoms in sick children result in 5% higher parental self-efficacy among the parents who were allowed to watch the material. Moreover, it will be studied if the new material resulted in less children examined by a doctor, and satisfied parents. Method: Parents who call the medical helpline about a medically ill child aged 6 months to 12 years will be offered to try the new material. If they accept, every second parent will be allowed given access to the new material, and every other parent will receive the usual triage by telephone. The results of these otherwise similar groups will be compared. Parents answer surveys about their experiences. Yield: Videos and simple text may empower parents to handle their sick children. The study may result in fewer children referred to hospitals, more appropriate use of resources and better experiences for the families.