bioihbjkbjnl/mcl2 huggingface dataset:
Open-Label Extension Study of the Long-Term Effects of Migalastat HCL in Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Intervention: migalastat HCl 150 mg
Intervention description: Migalastat HCl 150 mg (equivalent to 123 mg migalastat) was provided as capsules in blister packs. One capsule was taken orally every other day.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Amicus Therapeutics; Galafold; Migalastat; AT1001

Summary:

      This is an open-label extension study intended to provide continued treatment with migalastat
      hydrochloride (HCl) for participants with Fabry disease who completed treatment of a previous
      migalastat HCl study. The study assessed the long-term safety and effectiveness of migalastat
      HCl.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had completed treatment in a previous study of migalastat HCl given as a
             monotherapy

          -  Male and female participant agreed to use protocol-identified acceptable contraception

          -  Participant was willing to provide written informed consent and authorization for use
             and disclosure of Personal Health Information (PHI)

        Exclusion Criteria:

          -  Participant's last available estimated glomerular filtration rate (eGFR) in the
             previous study was <30 milliliter (mL)/minute (min)/1.73 meters squared (m^2); unless
             there was measured GFR available within 3 months of Baseline Visit, which was >30
             mL/min/1.73 m^2

          -  Participant had undergone, or was scheduled to undergo kidney transplantation or was
             currently on dialysis

          -  Participant had a documented transient ischemic attack, stroke, unstable angina, or
             myocardial infarction within the 3 months before Baseline Visit

          -  Participant had clinically significant unstable cardiac disease in the opinion of the
             investigator (for example, cardiac disease requiring active management, such as
             symptomatic arrhythmia, unstable angina, or New York Heart Association class III or IV
             congestive heart failure)

          -  Participant had a history of allergy or sensitivity to AT1001 (including excipients)
             or other iminosugars (for example, miglustat, miglitol)

          -  Participant required treatment with Glyset® (miglitol) or Zavesca® (miglustat)

          -  Participants with severe or unsuitable concomitant medical condition

          -  Participants with clinically significant abnormal laboratory value(s) and/or
             clinically significant electrocardiogram (ECG) findings
Safety and Efficacy of Vilazodone in Adolescent Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Vilazodone; Vilazodone
Intervention description: Dose matched placebo tablets, once per day, oral administration.; Vilazodone tablets, 15 mg per day, oral administration; Vilazodone tablets, 30 mg once per day, oral administration
Intervention MeSH terms: Vilazodone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 529.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone
      relative to placebo in adolescent outpatients (12-17) with major depressive disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female outpatients between 12-17 years of age

          -  Primary diagnosis of major depressive disorder (MDD)

          -  Children's Depression Rating Scale-Revised (CDRS-R) score of 40 or greater

          -  Clinical Global Impressions-Severity (CGI-S) score of 4 or greater

        Exclusion Criteria:

          -  Current (past 3 months) principal Diagnostic and Statistical Manual of Mental
             Disorders, 4th edition, Text Revision (DSM-IV-TR) based diagnosis of an axis disorder
             other than major depressive disorder (MDD) that is the primary focus of treatment.

          -  History of suicidal behavior, or requires precaution against suicide

          -  Not generally healthy medical condition

          -  Seizure disorder
Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis
Intervention: LDV/SOF; RBV
Intervention description: 90/400 mg FDC tablet administered orally once daily; Tablets administered orally in a divided daily dose according to weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Virus (HCV); Ledipasvir/Sofosbuvir; Ribavirin

Summary:

      The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
      ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without
      ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or
      LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  HCV RNA > 15 IU/mL at screening

          -  HCV genotype 1 or 4

          -  Chronic HCV infection (≥ 6 months)

          -  Prior virologic failure after treatment with SOF in combination with simeprevir (SMV)
             ± RBV or with RBV ± pegylated interferon (PEG)

          -  Cirrhotic and non-cirrhotic as determined by standard methods

          -  Male and female individuals of childbearing potential who engage in heterosexual
             intercourse must agree to use protocol specified method(s) of contraception

        Key Exclusion Criteria:

          -  Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors

          -  Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF

          -  Pregnant or nursing female or male with pregnant female partner

          -  Coinfection with HIV or hepatitis B virus

          -  Current or prior history of clinical hepatic decompensation

          -  Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin
             cancers)

          -  Chronic use of systemic immunosuppressive agents

          -  History of clinically significant illness or any other medical disorder that may
             interfere with individual's treatment, assessment or compliance with the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer
Condition: Prostate Cancer; Male Erectile Disorder; Stage I Prostate Cancer; Stage II Prostate Cancer
MeSH terms: Prostatic Neoplasms; Erectile Dysfunction
Intervention: sildenafil citrate; alprostadil; robotic-assisted laparoscopic surgery; quality-of-life assessment; questionnaire administration
Intervention description: Given orally; Given intraurethrally; Undergo prostatectomy; Ancillary studies; Ancillary studies
Intervention MeSH terms: Sildenafil Citrate; Alprostadil
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone
      prostatectomy for prostate cancer to recover from erectile dysfunction.

      PURPOSE: This randomized clinical trial is studying giving sildenafil together with
      alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical
      prostatectomy for nonmetastatic prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria

          -  All patients undergoing BNS-RAP for prostate cancer will be asked to participate

          -  Ability to achieve erections sufficient for intercourse prior to surgery and an
             SHIMS-5 score of >= 22

          -  Must maintain follow up care at COH for visits 1, 3, 6, 9, 12, and 18 months post
             surgery

          -  Participants willing to participate on study for a minimum of 18 months

          -  Consented participant on the Prostate database study (protocol 00149)

          -  Patients must have a clinical stage of < T3

          -  Gleason score < 8 on post-operative pathological sample prior to randomization

        Exclusion Criteria

          -  Metastatic disease

          -  Coronary artery disease on nitrate therapy (including oral sublingual nitrates)

          -  Unable to maintain follow up visits at COH at 1, 3, 6, 9, 12, and 18 months
             post-operatively

          -  Pathology diagnosis >= pT3

          -  Prior hormonal treatment use for prostate cancer or low serum testosterone

          -  Allergy to prostaglandin PGE1, Lidocaine, or Viagra

          -  Gleason score >= 8 on post-operative pathological sample prior to randomization

          -  Concomitant use of cytochrome P450 3AY inhibitors (cimetidine, erythromycin,
             ketoconazole, or protease inhibitors)

          -  SHIMS-5 score =< 21
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Placebo (for Alirocumab); Non-statin LMT; Diet Alone
Intervention description: Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).; Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).; Ezetimibe or Fenofibrate at stable dose as background therapy.; Stable cholesterol-lowering diet as background therapy.
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind treatment period of 24 weeks (3 parallel arms) followed by an open-label extension period (single arm)
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Masking during the double-blind treatment period
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of
      Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin
      lipid modifying background therapy or as monotherapy in comparison with placebo in
      participants with primary hypercholesterolemia not treated with a statin.

      Secondary Objective:

        -  To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus
           placebo.

        -  To evaluate the safety and tolerability of Alirocumab 150 mg Q4W.

      Alirocumab 75 mg Q2W was added as a calibrator arm.
    

Eligibility criteria:

        Inclusion criteria:

        Participants with primary hypercholesterolemia (heterozygous familial hypercholesterolemia
        [heFH] or non-FH) not adequately controlled with their non-statin LMT (either ezetimibe or
        fenofibrate) or diet alone.

        Exclusion criteria:

          -  LDL-C <70 mg/dL (1.81 mmol/L) at screening for statin intolerant participants at very
             high cardiovascular (CV) risk;

          -  LDL-C <100 mg/dL (<2.59 mmol/L) at screening for statin intolerant participants at
             high or moderate CV risk or, participants not fulfilling the statin intolerant
             definition at moderate CV risk;

          -  LDL-C ≥160 mg/dL (≥4.1 mmol/L) at screening for participants receiving diet only or,
             participants not fulfilling the statin intolerant definition at moderate CV risk and
             receiving a non-statin LMT.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Dexamethasone in Reducing Everolimus-Induced Oral Stomatitis in Patients With Cancer
Condition: Malignant Neoplasm
MeSH terms: Neoplasms; Stomatitis
Intervention: Dexamethasone; Placebo; Questionnaire; Quality-of-Life Assessment; Everolimus
Intervention description: Given as mouthwash; Given as mouthwash; Ancillary studies; Ancillary studies; Standard of care
Intervention MeSH terms: Dexamethasone; Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase III trial studies how well dexamethasone works in reducing everolimus-induced oral
      stomatitis in patients with cancer. Dexamethasone may help to reduce the everolimus-induced
      oral stomatitis so as to improve quality of life in cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current cancer diagnosis, about to receive oral everolimus 10 mg/day with or without
             an endocrine agent. Patients about to receive everolimus for off label use for any
             cancer are also eligible.

          -  Not currently receiving chemotherapy or any other agent known to cause mucositis or
             stomatitis. Trastuzumab and ovarian function suppression are allowed.

          -  Any prior chemotherapy or other stomatitis/mucositis-causing therapy must be completed
             at least 2 weeks prior to registration.

          -  Not currently suffering from stomatitis/mucositis or mouth ulcers. Patients should not
             have had any stomatitis or mouth pain for at least 7 days prior to registration.

          -  Patients should not receive any other agent which would be considered treatment for
             stomatitis or impact the primary endpoint.

          -  No history of candida infection (thrush) within the last 3 months.

          -  Not currently being treated with corticosteroids.

          -  No uncontrolled diabetes mellitus, defined by hemoglobin A1C greater than 8%, although
             A1C is not needed for all patients, hemoglobin (Hgb)A1C < 8 is required for everyone
             with diabetes or suspected diabetes.

          -  Patients must be able to read and comprehend English. Local translation, including
             verbal translation of professionals (PROs) is not permitted.

          -  Not pregnant and not nursing, because this study involves an investigational agent
             whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn
             are unknown. Therefore, for women of childbearing potential only, a negative pregnancy
             test done =< 7 days prior to registration is required.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: RVT-101; Placebo
Intervention description: once daily, oral, 35 mg tablets; once daily, oral, pill manufactured to match RVT-101 35 mg tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1315.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's disease; RVT-101; donepezil; intepirdine; dementia

Summary:

      This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an
      adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject with AD

          -  Ongoing donepezil therapy for AD

          -  An MMSE score 12 to 24 inclusive at Screening; MMSE score 10-26 inclusive at Baseline

          -  Hachinski Ischaemia score less than or equal to 4 at Screening.

          -  If female, subject must be: a. of non-childbearing potential or surgically sterile;
             or, b. willing to use an adequate methods of birth control. Male subjects who are
             sexually active will also be required to use an adequate form of birth control.

          -  Subject has the ability to comply with procedures for cognitive and other testing in
             the opinion of the investigator.

          -  Subject has a reliable caregiver who is willing to report on subject's status
             throughout the study.

        Exclusion Criteria:

        Other Causes for Dementia

          -  Diagnosis of vascular dementia

          -  Atypical clinical features or clinical course of dementia that would lead the
             investigator to conclude symptoms are more likely due to an alternate dementia
             diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia,
             or others.

        Confounding Medical Conditions

          -  History of significant psychiatric illness such as schizophrenia or bipolar affective
             disorder or any other significant psychiatric illness that in the opinion of the
             investigator would interfere with participation in the study;

          -  Any clinically relevant concomitant disease, which, in the opinion of the
             investigator, makes the subject unsuitable for inclusion in the study.
Use of Dexamethasone in Pediatric Asthma Exacerbations
Condition: Asthma
MeSH terms: Asthma
Intervention: Dexamethasone Sodium Phosphate Injection
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 318.0
Sex: All
Minimum age: 2 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Pediatric; Asthma; Exacerbation; Dexamethasone

Summary:

      The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs.
      two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 2 to 20 years, from all race and ethnicity groups, with a known history
             of asthma who present to the Emergency Department of Women and Children's Hospital of
             Buffalo with an acute exacerbation of mild or moderate asthma are potentially eligible
             for the study. Patients with severe asthma exacerbations will require intravenous
             steroid therapy, therefore, they will not be enrolled in the study. The investigators
             plan to enroll patients from winter of 2014 to fall 2016.

        History of asthma is defined by physician diagnosis of at least 1 prior episode of wheezing
        which responded to beta agonist medication.

        Mild asthma is defined as: Pediatric Asthma Score (PAS) of 5 to 7; Moderate asthma is
        defined as: PAS of 8 to 11; Severe asthma is defined as: PAS of 12 or more.

        Exclusion Criteria:

          -  Children who have one of the following conditions will be excluded from the study: are
             less than 2 years of age, have signs of severe exacerbation (Pediatric Asthma Score of
             more than 11), have used oral steroids in the last 2 weeks, have chronic lung disease
             (e.g., cystic fibrosis), have been given IV solumedrol, or vomit two doses of
             dexamethasone in emergency department.
Safety and Efficacy of Switching From Dolutegravir and ABC/3TC or ABC/DTG/3TC to B/F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed
Condition: HIV-1 Infection
Intervention: ABC/DTG/3TC; B/F/TAF; ABC/DTG/3TC Placebo; B/F/TAF Placebo
Intervention description: 600/50/300 mg FDC tablets administered orally once daily without regard to food; 50/200/25 mg FDC tablets administered orally once daily without regard to food; Tablets administered orally once daily without regard to food; Tablets administered orally once daily without regard to food
Intervention MeSH terms: Tenofovir; Emtricitabine; Lamivudine; Emtricitabine tenofovir alafenamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 567.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the efficacy of switching from a regimen
      of dolutegravir (DTG) and abacavir/lamivudine (ABC/3TC) or a fixed dose combination (FDC) of
      abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) to a FDC of
      bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) versus continuing DTG and ABC/3TC
      as the FDC ABC/DTG/3TC in virologically suppressed Human Immunodeficiency Virus- 1 (HIV-1)
      infected adults.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).

          -  Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for
             ≥ 3 months prior to the screening visit.

          -  HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit.

          -  Currently on a stable regimen for ≥ 3 months preceding the screening visit with
             documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening
             visit (or undetectable HIV-1 RNA level according to the local assay being used if the
             limit of detection is ≥ 50 copies/mL).

          -  Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV),
             DTG, ABC or 3TC.

        Key Exclusion Criteria:

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with subject study compliance.

          -  Active tuberculosis infection.

          -  Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or
             variceal bleeding).

          -  Females who are pregnant.

          -  Females who are breastfeeding.

          -  Acute hepatitis in the 30 days prior to study entry.

          -  Chronic Hepatitis B Virus (HBV) infection.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.