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NCT ID: NCT02559817 Terminated - Clinical trials for Irritable Bowel Syndrome With Constipation

A Safety and Efficacy Study of a Range of Linaclotide Doses Administered Orally to Children Ages 7-17 Years, With Irritable Bowel Syndrome With Constipation

LIN-MD-63
Start date: November 1, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of linaclotide for the treatment of Irritable Bowel syndrome with Constipation (IBS-C), in children age 7-17 years. This study includes up to a 4-week Screening Period, and a 2 to 3-week Pretreatment Period. Patients age 7-11 will receive oral liquid or oral solid capsule and patients 12-17 will receive solid oral capsule formulation. Children ages 7-11 years meeting the entry criteria will be randomized to 1 of 3 doses of linaclotide or placebo for 4 weeks. Children ages 12-17 years meeting the entry criteria will be randomized to 1 of 4 doses of linaclotide or placebo for 4 weeks. This 4-week study will assess the effects of linaclotide on bowel movement frequency, as well as other bowel symptoms of IBS-C.

NCT ID: NCT02559739 Completed - Stroke Clinical Trials

Sleep Deficiency and Stroke Outcome

Start date: July 2015
Phase:
Study type: Observational

Deficient sleep duration and sleep disturbances - such as insomnia, sleep disordered breathing (SDB) and restless legs syndrome (RLS)- are associated with hypertension and cardio-cerebrovascular morbidity and mortality. Several studies suggest that sleep disorders are frequent after stroke and detrimental for stroke outcome. However, more prospective studies in a large unselected sample of stroke survivors are needed to better investigate the short- and long-term consequences of sleep disturbances on mortality and occurrence of new cardio-cerebrovascular events. Also their pathophysiological mechanisms and their influence on stroke recovery should be better understood. Therefore, the aim of this study is to assess the impact of sleep deficiency and sleep fragmentation on the frequency of new cerebro- and cardiovascular events and death after stroke or transient ischemic attacks, and clinical outcome within one and two years after stroke. The working hypotheses are that stroke survivors with sleep deficiency and sleep fragmentation due to insomnia, sleep-disordered breathing or restless leg syndrome will present: (1) higher mortality from all causes and higher frequency of new cardio-/ cerebrovascular events; and (2) a less favorable clinical outcome. Outcomes will be compared between patients with and without sleep deficiency and fragmentation. Since current clinical practice in cerebrovascular patients does not sufficiently consider sleep disorders in patient's management, this study can help to bring attention to a still overlooked medical problem and change the current standard of management of stroke survivors.

NCT ID: NCT02559427 Withdrawn - Clinical trials for Obstructive Sleep Apnea Syndrome

SPA Therapy in the Treatment of Sleep Apnea Syndrome

THERMA-SAS
Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether 3-week of SPA therapy improves sleep apnea in patients with chronic venous insufficiency and concomitant Obstructive Sleep Apnea Syndrome (OSAS).

NCT ID: NCT02559245 Completed - Clinical trials for Irritable Bowel Syndrome Predominant Constipation

Effect of Flixweed and Fig on Irritable Bowel Syndrome With Predominant Constipation: a Single Blind Randomized Clinical Trial.

Start date: September 2015
Phase: N/A
Study type: Interventional

This study evaluates effect of Ficus carica and Descurainia Sophia on irritable bowel syndrome predominant constipation. one-third of patients will receive Ficus carica, another one-third will receive Descurainia Sophia and remained patients only will follow their regular diet for 4 months.

NCT ID: NCT02559206 Completed - Clinical trials for Irritable Bowel Syndrome With Constipation

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Start date: October 22, 2015
Phase: Phase 2
Study type: Interventional

The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of linaclotide).

NCT ID: NCT02558972 Active, not recruiting - Clinical trials for Postural Tachycardia Syndrome (POTS)

Northera Improves Postural Tachycardia Syndrome (POTS) and Postural Vasovagal Syncope (VVS)

Start date: September 2015
Phase: Phase 2
Study type: Interventional

Vasovagal syncope (VVS, simple faint) is the most common cause of transient loss of consciousness and represents the acute episodic form of orthostatic intolerance (OI). Postural tachycardia syndrome (POTS) is the common chronic form of OI. Both are defined by debilitating symptoms and signs while upright relieved by recumbency. Northera should therefore improve both sympathetic splanchnic arterial vasoconstriction and sympathetic splanchnic venoconstriction in POTS and VVS, and may represent an ideal drug to improve the orthostatic response in POTS and VVS.

NCT ID: NCT02558933 Completed - Clinical trials for Fetal Alcohol Syndrome (FAS)

Epigallocatechin Gallate (EGCG) to Improve Cognitive Performance in Foetal Alcohol Syndrome (FAS) Children

Neuro-SAF
Start date: March 2016
Phase: N/A
Study type: Interventional

The flavonoid epigallocatechin gallate (EGCG) is a modulator of neuronal plasticity useful in other neurodevelopmental diseases. A recent study showed that EGCG is a promising tool for cognitive and health related quality of life improvement in Down's syndrome. The objective is to determine the efficacy of EGCG as a therapeutic candidate for the improvement of cognitive performance in FAS patients. Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of EGCG. It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment.

NCT ID: NCT02553941 Completed - Clinical trials for Chronic Myelomonocytic Leukemia

Ibrutinib and Azacitidine for Treatment of Higher Risk Myelodysplastic Syndrome

Start date: May 17, 2016
Phase: Phase 1
Study type: Interventional

This phase Ib trial studies the side effects and best dose of ibrutinib when given together with azacitidine in treating patients with myelodysplastic syndrome that is likely to occur or spread (higher risk) and who were previously treated or untreated and unfit for or refused intense therapy. Ibrutinib and azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT02553811 Completed - Clinical trials for Carpal Tunnel Syndrome

Diagnosis of Carpal Tunnel Syndrome: Effectiveness of Diagnostic Tests. Clinical Trial of Accuracy

DCTS
Start date: October 2015
Phase: N/A
Study type: Interventional

There is no golden universal standard for the diagnosis of Carpal Tunnel Syndrome (CTS). In this scenario, for a comparison of the effectiveness of the principal diagnostic tests CTS should determine how they affect the likelihood of disease through a clinical accuracy trial of good methodological quality in order to get answers to what is the best diagnostic strategy in clinical CTS practice. The paresthesia in nerve distribution territory median hands is the most common symptom in patients with CTS. The nuisance caused by paresthesia directly affects the quality of life of patients and impairs daily manual activities and sleep quality. To evaluate the remission of paresthesia is a major clinical criterion for improved STC being an expected relevant outcome for the patient. This study evaluated and compared the diagnostic accuracy of the ultrasonography (US) and electromyography (EMG), considering the postoperative status of remission of paresthesia as the reference standard in the diagnosis of CTS.

NCT ID: NCT02551367 Not yet recruiting - Clinical trials for Polycystic Ovary Syndrome

Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS )

LVCCFOROI
Start date: October 2015
Phase: Phase 2
Study type: Interventional

110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35 distributed randomly : - 55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles. - 55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles. Patients will be subjected to: Complete history taking: 1. Details about name, age 2. Menstrual history with determination of menarche 3. Amenorrhea or oligomenorrhea , Regularity of the cycle 4. History of endocrine disease. 5. History of previous operations. - Physical examination: - General examination: With special concern to: --Acne. --Hirsutism . --Weight. --Height --BMI was determined : Wt. in kg ـــــــــــــــــــ = ) Height in m)2 - Abdominal examination : - for scar of previous pelvic or abdominal operations . - Pelvic examination : - vaginal examination for enlarged cystic ovaries. - ultrasound for diagnosis of pcos. PARAMETERS: (1) rate of ovulation (primary parameter). (2) serum progesterone level on day 21. (3) number of mature follicles produced per cycle. (4) mean endometrial thickness. (6) chemical pregnancy. (7) ongoing pregnancy