bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Melatonin in Outpatients Infected With COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Melatonin; Placebo (Methylcellulose) capsule
Intervention description: Melatonin will be administered orally as a 10 mg dose three times a day for 14 days. Size 4 clear vegetable cellulose capsules containing 10 mg melatonin, microcrystalline cellulose, and rice concentrate prepared by Life Extension® will be over-encapsulated in opaque gelatin capsules. Over-encapsulation of melatonin treatments will be done by the research pharmacist and will be mailed to study subjects directly by courier. Melatonin capsules will be stored at room temperature.; Placebo capsules will be prepared with opaque gelatin capsules, filled using methylcellulose and over-encapsulated to appear identical to interventional drug. Placebo capsules will be given orally in the same regimen as intervention (three times daily for 14 days). Capsules will be prepared by the research pharmacist and will be mailed to study subjects directly by courier. Placebo capsules will be stored at room temperature.
Intervention MeSH terms: Melatonin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: placebo-controlled randomized double-blind pilot trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Melatonin; COVID-19; SARS-CoV-2

Summary:

      This study is a pilot randomized, double-blind, placebo-controlled clinical trial to evaluate
      the safety and efficacy of melatonin in adult outpatients suspected to be afflicted with
      COVID-19.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant female adult ≥18 years of age at time of enrollment.

          -  Women of childbearing potential must agree to use at least one primary form of
             contraception for the duration of the study.

          -  Subject provides written informed consent prior to initiation of any study procedures.

          -  Understands and agrees to comply with planned study procedures.

          -  Agrees to the collection and storage of saliva samples per protocol.

        Exclusion Criteria:

          -  Severe chronic liver disease

          -  Severe chronic kidney disease or requiring dialysis

          -  Pregnancy or breast feeding.

          -  Allergy to the study medication

          -  Currently taking melatonin

          -  Currently taking high dose (>500 mg/day) Vitamin C
Myelodysplastic Syndromes (MDS) Event Free Survival With Iron Chelation Therapy Study
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Deferasirox; Placebo
Intervention description: Deferasirox provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use; Inactive ingredients used as a placebo comparator, provided as 125 mg, 250 mg, and 500 mg dispersible tablets for oral use
Intervention MeSH terms: Deferasirox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Patients, investigator staff, persons performing the assessments, and data analysts remained blind to the identity of the study treatment from the time of randomization until database lock.
Enrollment: 225.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: TELESTO; MDS Study; Myelodysplastic Syndromes; Myelodysplastic Syndromes (low-int-1 risk)

Summary:

      This was a randomized, double-blind trial to evaluate deferasirox vs placebo in patients with
      myelodysplastic syndromes (low/int-1 risk) and transfusional iron overload .The trial was
      conducted in 17 countries, started in 2010 and ended in 2018.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Weigh between 35-135 kilograms

          -  Low or int-1 risk MDS

          -  Ferritin >1000 micrograms/liter at screening

          -  History of transfusion of 15 to 75 Packed Red Blood Cells (PRBC) units

          -  Anticipated to be transfused with at least 8 units of PRBCs annually during the study

          -  Women of child-bearing potential using effective methods of contraception during
             dosing of study treatment

        Exclusion Criteria:

          -  More than 6 months of cumulative ICT (such as daily deferasirox (Exjade®) or
             deferiprone or 5×/week deferoxamine)

          -  More than 3 years since patient began receiving regular transfusions (2 units per 8
             weeks or 4 units received in a 3 month period)

          -  Significant proteinuria

          -  History of hospitalization for congestive heart failure; other heart conditions as
             specified in the protocol

          -  Systemic diseases which would prevent study treatment

          -  Hepatitis B; Hepatitis C; HIV

          -  Liver cirrhosis

          -  Pregnant, or breast-feeding patients, or patients of child-bearing potential not
             employing an effective method of birth control

          -  History of drug or alcohol abuse within the 12 months prior to enrollment
Vitamin B12a Vasoplegic Syndrome
Condition: Vasoplegic Syndrome
MeSH terms: Vasoplegia; Syndrome
Intervention: Hydroxocobalamin; Cardiopulmonary Bypass; Placebos
Intervention description: 5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.; Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.; Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Masking and blinding will be carried out by the research pharmacy with unmasking to be performed at study completion through the research pharmacy and statistician.
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin B12a; Hypotension; Cardiopulmonary Bypass

Summary:

      The study team will evaluate the medication Hydroxocobalamin (B12a) for treatment of low
      blood pressure after cardiac surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient for whom we are able to obtain consent ahead of their procedure

          -  Patients presenting for a procedure in which cardiopulmonary bypass will be required

          -  Considered high risk for vasoplegic syndrome

          -  Has no contraindications to arterial line or PA catheter placement

          -  Develops high-dose vasopressors for 30 min or longer and refractory hypotension
             consistent with vasoplegic syndrome within 24 hours of coming off cardiopulmonary
             bypass.

        Exclusion Criteria:

          -  Age<18 years

          -  Known pregnancy or patients without a documented pregnancy test if not menopausal.

          -  Known prior anaphylactic or allergic reaction to B12a

          -  CKD stage 4 or worse

          -  ECMO (extracorporeal membrane oxygenation) prior to study consent.

          -  Patients currently on cardiopulmonary bypass
A Trial of Sertraline in Young Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Sertraline Liquid Placebo; Sertraline
Intervention description: Liquid placebo given in parallel to active medication; Active medication
Intervention MeSH terms: Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 24 Months
Maximum age: 72 Months
Healthy volunteers: No
Keywords: Autism Spectrum Disorder; Behavior; sertraline; treatment

Summary:

      This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old
      inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant
      will receive a series of tests at both the beginning and end of the study. The researchers
      hope to show improvements in language and social deficits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documentation of Autism Spectrum Disorder with Diagnostic and Statistical Manual for
             Mental Disorders-Fifth edition, criteria as well as a standardized autism assessment
             such as the Autism Diagnostic Observation Schedule or the Autism Diagnostic
             Interview-Revised.

          -  Subject between the ages of 24-72 months of age.

          -  A reliable parent or caregiver who can report the side effects and communicate
             effectively with the research team.

          -  Stable medications during the two months prior to enrollment.

          -  Currently receiving interventions in the community or school for Autism Spectrum
             Disorder

        Exclusion Criteria:

          -  Current or past Selective Serotonin Reuptake Inhibitor treatment.

          -  Other serious co-morbid medical disorders affecting brain function and behavior,
             including uncontrolled seizures.
CONTAIN COVID-19: Convalescent Plasma to Limit COVID-19 Complications in Hospitalized Patients
Condition: COVID-19; Coronavirus; Coronavirus Infection
MeSH terms: COVID-19; Coronavirus Infections
Intervention: Convalescent Plasma; Saline solution
Intervention description: SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate; Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 941.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, blinded phase 2 trial that will assess the efficacy and safety of
      anti-SARS-CoV-2 convalescent plasma in hospitalized patients with acute respiratory symptoms
      requiring oxygen supplementation.
    

Eligibility criteria:

        Inclusion Criteria

          1. Patients ≥18 years of age

          2. Hospitalized with laboratory confirmed COVID-19

          3. One or more of the following respiratory signs or symptoms: cough, chest pain,
             shortness of breath, fever, oxygen saturation ≤ 94%, abnormal CXR/CT imaging)

          4. Hospitalized for ≤ 72 hours OR within day 3 to 7 days from first signs of illness

          5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen

          6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID -19
             and patients who meet eligibility criteria will not be excluded on this basis.

        Exclusion Criteria

          1. Receipt of pooled immunoglobulin in past 30 days

          2. Contraindication to transfusion or history of prior reactions to transfusion blood
             products

          3. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)

          4. Volume overload secondary to congestive heart failure or renal failure

          5. Unlikely to survive past 72 hours from screening based on the assessment of the
             investigator

          6. Unlikely to be able to assess and follow outcome due to poor functional status
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: BMS-986165; Placebo
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Deucravacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in
      participants with moderate to severe ulcerative colitis (UC).
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and
             confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization
             visit

          -  Must have documented diagnosis of UC of at least 3 months' duration prior to screening

          -  Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9
             points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal
             bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2

        Exclusion Criteria:

          -  Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis,
             or pseudomembranous colitis (other than associated with Clostridium difficile [C.
             difficile])

          -  Stool positive for C. difficile toxin at screening visit

          -  Current or recent (within 12 weeks prior to the randomization visit) evidence of
             fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation

        Other protocol-defined inclusion/exclusion criteria apply
Contrast Enhanced Ultrasound for Evaluation of Reflux Nephropathy
Condition: Urinary Tract Infection; Vesicoureteral Reflux
MeSH terms: Urinary Tract Infections; Gastroesophageal Reflux; Vesico-Ureteral Reflux
Intervention: Sulfur hexafluoride type-a lipid microspheres
Intervention description: Used as a contrast to enhance renal ultrasound
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 8 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study will be evaluating the efficacy and safety of a contrast drug in pediatric renal
      ultrasound.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent

          -  Age more than or equal to 8 years

          -  Patient with history of urinary tract infection (UTI) and history of Voiding
             Cystourethrogram (VCUG) for vesicoureteral reflux

          -  Candidate for Dimercaptosuccinic acid (DMSA) scan or scan for renal scar

          -  Demonstration of renal scarring by DMSA scan or renal ultrasound without contrast

        Includes healthy volunteers

        Exclusion Criteria:

          -  Age less than 8years

          -  Allergy to contrast or related products

          -  Cardiac shunt/ congenital heart anomalies

          -  Abnormal baseline ECG

          -  Open heart surgery

          -  Evidence of retinopathy

          -  Patient in intensive care

          -  Unable to comply with study requirement

          -  History of emphysema

          -  Unable to maintain oxygen saturation of 92% on at room air

          -  Pregnancy and lactation
A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
Condition: Microvascular Obstruction
Intervention: Temanogrel; Placebo
Intervention description: Participants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure); Participants will receive a single intravenous dose of temanogrel matching placebo on Day 1
Intervention MeSH terms: APD791
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Temanogrel; Microvascular obstruction; APD791; Percutaneous coronary intervention; MVO; PCI

Summary:

      The purpose of this study is to determine whether intravenous temanogrel is a safe and
      effective treatment for microvascular obstruction (MVO) in adult participants undergoing
      percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable angina participants suitable for elective PCI, or participants suitable for PCI
             for diagnosis of non-ST-elevation myocardial infarction or unstable angina (NSTEMI/UA)
             who are consistently hemodynamically stable until the time of PCI and have a
             thrombolysis in myocardial infarction (TIMI) Flow Grade 2 or 3 on the diagnostic
             angiography

          -  Target lesions for PCI must appear suitable for stenting as confirmed on the
             diagnostic angiography and must satisfy the study criteria regarding lesion size and
             vessel diameter/type.

          -  Females must not be of childbearing potential

          -  Males with pregnant or non-pregnant female partners of childbearing potential must
             agree to using a condom during treatment and for 90 days following treatment

        Exclusion Criteria:

          -  Planned or anticipated use of rotational atherectomy/ablation or shockwave therapies
             during the PCI procedure

          -  Any history of stroke, seizure, intracranial bleeding, or intracranial aneurysm

          -  Transient ischemic attack within the 6 months prior to Screening

          -  History of major trauma, major surgery, and/or clinically significant head injury or
             hemorrhage within the last 6 months of Screening

          -  Any ST-elevation myocardial infarction (STEMI) within 10 days of Screening or STEMI
             within the target vessel territory within the last 4 months of Screening
A Rollover Study of ARRY-371797 in Patients With LMNA-Related Dilated Cardiomyopathy
Condition: LMNA-Related Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated
Intervention: ARRY-371797, p38 inhibitor, oral
Intervention description: multiple dose, single schedule
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: laminopathy; ARRY-797

Summary:

      This is a rollover study designed to investigate the safety and effectiveness of
      investigational study drug ARRY-371797 in patients who previously received ARRY-371797 in a
      study for patients with LMNA-related dilated cardiomyopathy sponsored by Array BioPharma and
      may, in the Investigator's opinion, derive benefit from continued treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Received ARRY-371797 as treatment for a genetic dilated cardiomyopathy secondary to
             LMNA mutations in a clinical study sponsored by Array BioPharma.

          -  May, in the opinion of the Investigator, benefit from continued ARRY-371797 treatment.

          -  Additional criteria exist.

        Key Exclusion Criteria:

          -  Discontinued treatment in the parent study for any reason other than study completion
             or Sponsor termination of the study.

          -  Additional criteria exist.
Efficacy of D-Cycloserine for Enhancing the Effects of CBT for Substance Use
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Intervention: D-cycloserine; Placebo
Intervention description: Single dosage of D-cycloserine is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10); Single dosage of placebo is given prior to each of 6 sessions of CBT-IC treatment (sessions 5-10)
Intervention MeSH terms: Cycloserine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: cognitive-behavior therapy; d-cycloserine; cognitive enhancer; drug dependence; opiate dependence; exposure; isolated doses of d-cycloserine; isolated doses of matching pill placebo; DCS

Summary:

      This study examines whether isolated doses of d-cycloserine enhance the efficacy of an
      exposure-based cognitive-behavioral treatment for chronic and treatment refractory substance
      dependence.
    

Eligibility criteria:

        Inclusion criteria:

        The primary selection criteria include women and men between the ages of 18 and 65 who:

          1. Meet DSM-IV criteria for opiate dependence,

          2. Maintain a stable dose of methadone for two weeks prior to recruitment and:

               -  fail to achieve "take-home" status for methadone dosing during at least the first
                  four months of methadone treatment,

               -  test positive on at least two toxicology screens for illicit drugs during the
                  month prior to recruitment

               -  have never achieved two consecutive toxicology screens free of illicit substances
                  since entering the current treatment episode.

          3. Meet study criteria for chronic stress:

               -  unemployment criteria, and

               -  affective disorder criteria.

        Exclusion Criteria:

          1. Patients with significantly unstable or uncontrolled medical illness which may
             interfere with participation in treatment (e.g., patients likely to require
             hospitalization during the study period).

          2. Patients with a psychotic or organic mental disorder according to DSM-IV criteria.

          3. Patients receiving medication affecting methadone metabolism (e.g. rifampin).

          4. Patients with uncontrolled bipolar disorder as evidenced by meeting current criteria
             for mania or hypomania or meeting criteria for rapid cycling in the last year (as
             indicated by structured questioning of all patients meeting criteria for bipolar
             disorder).

          5. Patients unable to complete the informed consent or unable to understand study
             procedures in the informed consent process.

          6. Pregnancy or current alcohol use.