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NCT ID: NCT05530447 No longer available - Narcolepsy Clinical Trials

Expanded Access to SUVN-G3031 (Samelisant) for the Treatment of Subjects With Narcolepsy

Start date: n/a
Phase:
Study type: Expanded Access

The study is planned to provide expanded access treatment to subjects with narcolepsy who have completed the 2-week treatment phase and follow-up in study CTP2S13031H3 (NCT04072380), and in instances when the investigator as well as the subject believe that the benefits outweigh the risks to continue the treatment with SUVN-G3031.

NCT ID: NCT05541289 No longer available - COVID-19 Clinical Trials

Expanded Access Program of Whole, Inactivated COVID-19 Vaccine COVAXIN™ (BBV152) in Adults Aged 18 Years and Older

Start date: n/a
Phase:
Study type: Expanded Access

This Expanded Access, Phase 3, open label study is intended to provide access to COVAXIN™ (BBV152) to individuals who are at risk or have predisposing conditions that can lead to complications with the current immunization options against SAR-CoV-2 Virus infection.

NCT ID: NCT05582083 No longer available - Myelofibrosis Clinical Trials

Managed Access Program for Momelotinib in Myelofibrosis

Start date: n/a
Phase:
Study type: Expanded Access

Compassionate use access to Momelotinib/GSK3070785 for eligible participant with diagnosis of intermediate or high-risk myelofibrosis (MF), including primary myelofibrosis (PMF) or secondary myelofibrosis (post- polycythemia vera/ essential thrombocytopenia (PV/ET)), with anemia.

NCT ID: NCT05597436 No longer available - Clinical trials for Amyotrophic Lateral Sclerosis

Intermediate-Sized Expanded Access Study

Start date: n/a
Phase:
Study type: Expanded Access

This expanded access protocol is to provide access to the investigational product, SLS-005, to participants with ALS who are not eligible to participate in clinical trials.

NCT ID: NCT05624281 No longer available - Clinical trials for Lung Diseases, Interstitial (in Pediatric Populations)

A Treatment Protocol to Support the Care of Children and Adolescents With Fibrosing Interstitial Lung Disease (ILD)

Start date: n/a
Phase:
Study type: Expanded Access

This Expanded Access Program (EAP) is intended to facilitate the availability of OFEV® (nintedanib) to children and adolescents with chronic fibrosing interstitial lung disease (ILD) on top of current standard of care treatment and for whom no satisfactory authorized alternative therapy exists and who cannot participate in the ongoing 1199-0378 trial.

NCT ID: NCT05627466 No longer available - Clinical trials for Relapsed/Refractory Acute Myeloid Leukemia

US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia

Start date: n/a
Phase:
Study type: Expanded Access

The goal of this expanded access program is to provide rapid access to magrolimab free-of-cost material, to treat patients in the United States suffering from relapsed or refractory acute myeloid leukemia (AML).

NCT ID: NCT05683470 No longer available - Clinical trials for Expanded Access in Pancreatic Cancer

Expanded Access RBS2418 Treatment

Start date: n/a
Phase:
Study type: Expanded Access

This is an expanded access treatment protocol designed to provide access of RBS2418 to a single patient with pancreatic cancer.

NCT ID: NCT05686564 No longer available - Wilson Disease Clinical Trials

Early Access Program for ALXN1840 in Patients With Wilson Disease

Start date: n/a
Phase:
Study type: Expanded Access

This is an open-label, single-arm, multi-center EAP, designed to provide early access to ALXN1840 for eligible patients with WD.

NCT ID: NCT05692050 No longer available - Lymphoma Clinical Trials

Expanded Access to Epcoritamab

Start date: n/a
Phase:
Study type: Expanded Access

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to epcoritamab prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

NCT ID: NCT05753943 No longer available - Clinical trials for Sleep Initiation and Maintenance Disorders

CLINICAL TRIAL PHASE II, MULTICENTRIC, NATIONAL, DOUBLE-BLIND, PARALLEL, RANDOMIZED, AND PLACEBO-CONTROLLED FOR EVALUATION OF THE IMPROVEMENT OF SLEEP QUALITY IN PARTICIPANTS OF RESEARCH WITH INSOMNIA DISORDER

Start date: n/a
Phase:
Study type: Expanded Access

QUALI-001 code Phase II. Multicentric type. Test Product (QUALI-50) and (QUALI-75). Control Placebo capsule Primary goal Evaluate the improvement in sleep quality through the evaluation comparison of Pittsburgh Sleep Quality Index Scale scores obtained in visit 04 (final) compared to visit 02. Evaluate the impact of treatments on improving sleep quality and total sleep time through actigraphic evaluation obtained through the average of the data observed in the last 07 days of treatment, compared to the average of the data observed in the 07 days of the basal period. Outcome: A significant reduction in the score on the Scale is expected Pittsburgh Sleep Quality Index. A significant increase in sleep efficiency is expected and a significant decrease in sleep latency time and the number of arousals evaluated through actigraphy. Design Multicenter, randomized, placebo-controlled, parallel, with three treatments, in which each patient will receive treatment. Arm 01: Control Treatment: Sleep Hygiene + Basic Medications + Placebo Arm 02: Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system. Arm 03: Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system. Population Research participants of both sexes, diagnosed with Moderate or severe insomnia disorder. Control Treatment: Sleep Hygiene + Basic Medications + Placebo Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system Reviews of efficiency Sleep quality scales, actigraphic measures, and sleep diary sleep. Reviews of security Clinical examination, monitoring of adverse events, electrocardiogram, and laboratory tests. Criteria of Inclusion Agreement to participate in the study, documented through signature of the TCLE. Research participants diagnosed with Insomnia Disorder moderate or severe (≥ 10 points on the Pittsburgh scale). Stable research participant with outpatient treatment for Insomnia disorder for at least 60 days from visit 01 (initial). Age above 40 years. Research participants of both genders. Research participants were able to understand and provide their consent and complete the sleep diary and scales. Research participants with the ability to handle the actigraph properly. Women of childbearing age should accept the use of contraception during the study period. Men should accept the use of barrier contraceptives during the study period. Criteria of Exclusion Research participants who are using drugs like benzodiazepines or other anxiolytics that may induce/alter sleep. Research participant having made previous use of Trazodone for less than 90 days from visit 01 (initial). Research participants having used MAOIs during a period of up to 30 days from visit 01 (initial). Research participants using barbiturates. Research participants using Linezolid for up to 30 days from visit 01 (initial). Research participants with a history of hypersensitivity to drugs. Research participants with a history of prolonged erection or priapism, abnormal orgasm, urinary incontinence, retention urinary tract, erectile dysfunction, retrograde ejaculation, clitorism, hematuria, and pollakiuria. Research Participants with a History of Beverage Addiction alcohol at the discretion of the investigator. Research participants with a history of clinical disease at the discretion of the investigator may confound the study results or are significant for the safety of the research participant. Pregnant or breastfeeding women. Research participants with a history of psychiatric illness serious or uncontrolled may influence the ability of the research participant to respond to the procedures of the study. Research participants with a significant history of hypotension. Research participants with a history of angle-closure glaucoma closed, photophobia, diplopia, xerophthalmia, and eye pain. Research participants with a history of thyroid dysfunction significant or uncontrolled. Taking the following CNS depressant drugs: Carbamazepine, Buprenorphine/opioids, Inducing substrates or CYP3A4 inhibitors, Digoxin, phenytoin, Warfarin. Participants with prostatic hyperplasia. Size of sample: Inclusion of approximately 99 research participants, divided into 3 parallel arms.