bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)
Condition: Alopecia Universalis (AU); Alopecia Totalis (AT)
MeSH terms: Alopecia; Alopecia Areata
Intervention: Vehicle; ATI-50002
Intervention description: Vehicle Topical Solution; ATI-50002 Topical Solution
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective is to assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and
      AT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to comprehend and willing to sign an Informed Consent Form (ICF).

          -  Male or non-pregnant, non-nursing female ≥18 years old at the time of informed
             consent.

          -  Have a clinical diagnosis of stable, clinically typical, AU or AT.

          -  Have a duration of the current episode of AU or AT for a minimum of 6 months and a
             maximum of seven years.

          -  Be willing and able to follow all study instructions and to attend all study visits.

        Exclusion Criteria:

          -  Females who are nursing, pregnant, or planning to become pregnant for the duration of
             the study including 30 days after the last application of study medication.

          -  Patchy alopecia areata, diffuse alopecia areata or a history of an atypical pattern of
             Alopecia Areata (AA) (e.g., ophiasis, sisaihpo).

          -  Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a
             history of skin disease on the scalp that in the opinion of the investigator would
             interfere with the study assessments of efficacy or safety.

          -  Active scalp trauma or other condition affecting the scalp that, in the investigator's
             opinion, may affect the course of AU or AT or interfere with the study conduct or
             evaluations.

          -  The presence of a permanent or difficult to remove hairpiece or wig that will, in the
             opinion of the investigator, interfere with study assessments if not removed at each
             visit.
Effect of Losartan in Patients With Nonobstructive Hypertrophic Cardiomyopathy
Condition: Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Intervention: losartan; placebo
Intervention description: Losartan 50 mg b.i.d; Placebo b.i.d.
Intervention MeSH terms: Losartan; Angiotensin II; Angiotensin Receptor Antagonists
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertrophic nonobstructive cardiomyopathy

Summary:

      The purpose of this study is to determine whether taking losartan helps people with
      hypertrophic nonobstructive cardiomyopathy feel better by decreasing the amount of heart
      muscle thickening and/or the amount of heart muscle scarring.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with hypertrophic cardiomyopathy

          -  Left ventricular outflow tract (LVOT) gradient less than 30 mm Hg at rest

          -  Age 18 years or older

        Exclusion Criteria:

          -  Contraindication to losartan

          -  Already taking losartan

          -  Contraindication to MRI

          -  Hemodynamic instability
Generalized Anxiety Disorder Proof of Concept Efficacy and Safety Study of SEP-225441 (Eszopiclone) In GAD Subjects
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: eszopiclone; eszopiclone; Placebo
Intervention description: SEP-225441 (eszopiclone) total daily dose of 1.5 mg; SEP-225441 (eszopiclone) total daily dose of 0.9 mg; Placebo total daily dose 0.9 mg
Intervention MeSH terms: Eszopiclone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 456.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Anxiety

Summary:

      To determine the safety and efficacy of SEP-225441 (eszopiclone) in subjects with generalized
      anxiety disorder (GAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects must be between 18 and 50 years of age

          -  Subjects must have GAD

          -  Subjects must be in otherwise good general health

        Exclusion Criteria:

          -  Subject has a documented history of HIV, hepatitis B or hepatitis C.

          -  Subject has a recent history (within 6 months of study entry) or current diagnosis of
             Major Depressive Disorder, panic disorder (or 3 or more panic attacks in the past
             month). Post Traumatic Stress Disorder, body dysmorphic disorder, eating disorder, or
             other disorder.

          -  Subject has a history or presence of Obsessive-Compulsive Disorder (OCD), any
             psychotic, bipolar or schizophrenic disorder.

          -  Subject has presence or history of antisocial personality or other severe disorder

          -  Subject has refractory GAD (previously unresponsive to 2 or more adequate courses of
             SSRI, SNRI, benzodiazepine or non-benzodiazepine treatment for GAD).

          -  Subject has history of seizures, including febrile seizures.

          -  Subject has initiated psychotherapeutic intervention with 30 days; however, continued
             psychotherapy is allowed if stable and not specifically directed at GAD.

          -  Subject is undergoing or has undergone electroconvulsive therapy.

          -  Subject is a current smoker or has smoked within the last 12 months.

          -  Subject has donated blood within the past 30 days or plans to donate during and within
             30 days after study participation.
Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.
Condition: Endometrial Carcinoma
MeSH terms: Carcinoma; Endometrial Neoplasms
Intervention: Fulvestrant
Intervention description: A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Recurrent or metastatic endometrial carcinoma

Summary:

      The purpose of this study is to determine the efficacy of a monthly administration of
      Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of
      the clinical tumour response after 3 injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, recurrent or metastatic endometrial carcinoma

          -  Postmenopausal

          -  Hormonreceptor positive

        Exclusion Criteria:

          -  Pre-treatment with Fulvestrant

          -  Previous endocrine therapy of the endometrial carcinoma

          -  Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix,
             basal cell carcinoma or squamous carcinoma of the skin
Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Intervention: Rectal dialysis; Rectal dialysis
Intervention description: Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels; Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics; Aminosalicylates; Mucosal levels; Rectal dialysis

Summary:

      The investigators plan to develop a novel method of estimating 5-ASA levels in the rectum at
      a mucosal level using in vivo rectal dialysis technique towards the eventual goal of
      determining the optimal dosing of Asacol® that would provide therapeutic levels of 5-ASA in
      the left colon.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eligible subjects would be healthy males and females

          -  18-45 years of age (inclusive)

          -  Within 20% of normal body weight at screening

          -  Who are able to give written informed consent.

        Exclusion Criteria:

          -  History of any chronic illness

          -  Evidence of significant organic or psychiatric disease on a brief health questionnaire

          -  A history or presence of any condition causing malabsorption or an effect on
             gastrointestinal motility

          -  A history of any gastrointestinal surgery

          -  A history of acute or chronic renal insufficiency

          -  Pre existing liver disease

          -  A history of severe allergic reaction to salicylates, aminosalicylates or any of the
             ingredients of Asacol® tablets or a history of multiple food/drug allergies or if they
             are pregnant or lactating.

          -  Subjects will be required to refrain from any prescription or nonprescription drug or
             herbal products except their birth control medications for gastrointestinal disorders
             for 7 days prior to dosing and during the study, till its completion at the end of the
             fifth visit.
Safety and Efficacy Study of R932348 Ophthalmic Solution in Chronic Ocular Graft Versus Host Disease Patients(DROPS-2)
Condition: Chronic Graft-versus-host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Keratoconjunctivitis; Keratoconjunctivitis Sicca; Graft vs Host Disease
Intervention: R348 Ophthalmic Solution, 0.2%; R348 Ophthalmic Solution, 0.5%; Placebo Ophthalmic Solution
Intervention description: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day; R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day; Placebo Ophthalmic Solution 2 drops per eye twice a day
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Chronic Graft versus Host Disease; Keratoconjunctivitis Sicca

Summary:

      -  To assess the efficacy of R348 Ophthalmic Solutions administered for 12 weeks to
           subjects evaluated by objective and subjective measures.

        -  To investigate the safety and tolerability of R348 Ophthalmic Solutions administered for
           12 weeks to subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received an Allogeneic hematologic stem cell transplantation at least 3 months prior.

          -  Subjects with post Allogeneic hematologic stem cell transplantation onset or worsening
             of dry eye symptoms for at least 1 month prior.

          -  Use of over-the-counter and/or prescription eye drops for dry eye symptoms within 1
             month.

          -  Corneal fluorescein staining score of ≥ 2 in 1 region and ≥ 1 in at least 1 other
             region.

          -  Total lissamine green conjunctival staining score (according to a modified National
             Eye Institute grading system) of ≥ 2.

        Exclusion Criteria:

          -  Clinically unstable Graft versus Host Disease (requiring a change in immunosuppressive
             regimen), medical condition, or laboratory abnormality

          -  Used topical ophthalmic cyclosporine within 45 days.

          -  Used any topical ophthalmic steroid within 2 weeks.

          -  Used autologous serum eye drops within 2 weeks.
CD34+ Stem Cell Infusion to Augment Graft Function
Condition: Waning Donor Chimerism; Waning Immune Function; Primary Immunodeficiency Disease(s); Bone Marrow Failure
MeSH terms: Bone Marrow Failure Disorders; Pancytopenia; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Intervention: CD34+
Intervention description: CD34+ cells are selected using the CliniMACS System; without preparative regimen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Primary Immunodeficiency Disease(s); Mixed Donor Chimerism; bone marrow failure syndromes; allogeneic hematopoietic stem cell transplant (HSCT); children

Summary:

      The purpose of this study is to determine if infusing additional special donor cells will
      help to improve graft or immune function in previously transplanted children with immune
      deficiencies and bone marrow failures.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible for this protocol, patients must have the following:

          1. Primary immunodeficiency (e.g. SCID, Wiskott-Aldrich and/or other more rare conditions
             and other bone marrow failure syndromes) with prior allogeneic stem cell transplant.

          2. Waning donor chimerism or immune function that is inadequate to correct their disease
             or clinical condition, for which primary transplant was given, as determined by their
             attending physician.

          3. Available primary donor.

          4. Must not have other organ dysfunction deemed by the attending physician to preclude
             this procedure.

          5. Age < 35 years at time of transplant

          6. One of the following must be true:

               -  Patients must have evidence of persistent or recurrent immunodeficiency or
                  thrombocytopenia.

        -OR-

        • Primary immunodeficiency disease with known potential to progress to malignant condition
        if untreated.

        -OR-

        • Debilitating secondary disease known to be a consequence of inadequate immune response to
        known agent or pathogen, uncontrollable by other available medical therapies (e.g. third
        patient described on page 5).

        Exclusion Criteria:

          1. Absence of an available original donor

          2. Failure to sign consent form, or inability to undergo informed consent process

          3. Pregnant or lactating female

          4. Uncontrolled GVHD
Clinical Study to Assess the Efficacy, Safety and Tolerability of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Condition: Chronic Thromboembolic Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Macitentan; Placebo
Intervention description: Macitentan 10 mg, oral tablet, to be taken once daily.; Matching placebo oral tablet, to be taken once daily.
Intervention MeSH terms: Macitentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Chronic thromboembolic pulmonary hypertension (CTEPH)

Summary:

      Study to evaluate if macitentan is efficient, safe and tolerable enough to be used for
      treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  Subject with CTEPH (WHO Group 4) judged as inoperable due to the localization of the
             obstruction being surgically inaccessible (i.e., distal disease).

          -  Female of childbearing potential must have a negative pre-treatment serum pregnancy
             test, be advised on appropriate methods of contraception, and agree to use 2 reliable
             methods of contraception.

        Exclusion Criteria:

          -  Previous pulmonary endarterectomy.

          -  Recurrent thromboembolism despite sufficient oral anticoagulants.

          -  Symptomatic acute pulmonary embolism in the 6-month period prior to randomization.

          -  Known moderate-to-severe restrictive lung disease (i.e., TLC < 60% of predicted value)
             or obstructive lung disease (i.e., FEV1 < 70% of predicted, with FEV1/FVC < 65%) or
             known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial
             lung disease, emphysema).

          -  Acute or chronic conditions (other than dyspnea) that limit the ability to comply with
             study requirements in the 3-month period prior to Screening visit or during the
             Screening period.
Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Intervention: Kuvan; Diet
Intervention description: 20mg/kg by mouth once daily; Phenylalanine-restricted diet (4-10 mg/kg/day phenylalanine) using the prescribed phenylalanine-free medical formula and low protein foods tested with the patients for taste and acceptance to lower blood phenylalanine levels below 600 umol/l.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: PKU; Kuvan; BH4; tetrahydrobiopterin

Summary:

      The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness
      in the same patients with PKU when their blood phenylalanine concentrations are altered by
      diet.

      Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will
      increase the frequency of Kuvan responsiveness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  all patients with a diagnosis of phenylketonuria

          -  patients who are over the age of 4 years,

          -  patients with a fasting blood phenylalanine ≥600µmol/l

        Exclusion Criteria:

          -  female patients who are pregnant or attempting to become pregnant

          -  children under four years of age

          -  Concurrent disease of condition that would interfere with study participation or
             safety such as history of neurological compromise or major medical, psychiatric or
             learning disorder unrelated to PKU

          -  Any condition that, in the view of the Investigators, places subject at high risk of
             poor treatment compliance or of not completing the study

          -  Use of L-Dopa, methotrexate, or other drugs that may inhibit folate metabolism
A Study of Rilematovir (JNJ-53718678) in Adult Outpatients With Respiratory Syncytial Virus (RSV) Infection
Condition: Respiratory Syncytial Virus
MeSH terms: Infections; Virus Diseases
Intervention: Rilematovir; Placebo
Intervention description: Rilematovir 250 mg will be administered orally.; Placebo matching to rilematovir will be administered orally.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy of rilematovir compared to placebo with
      respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory
      tract disease (LRTD) symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presented to the healthcare facility with symptoms suggestive of a diagnosis of acute
             respiratory syncytial virus (RSV) infection

          -  Has at least 2 symptoms of lower respiratory tract disease (LRTD), one of which must
             be scored as at least 'moderate' if the symptoms did not pre-exist before RSV onset,
             or one of which is scored worse than usual if the symptoms pre-existed

          -  Tested positive for RSV infection using a molecular-based diagnostic assay (polymerase
             chain reaction [PCR] or other) on a bilateral nasal mid-turbinate swab sample

          -  Has at least one of the following high-risk conditions that predispose them to
             RSV-related disease progression: a. age greater than or equal to (>=) 65 years, b.
             congestive heart failure (CHF), c. chronic obstructive pulmonary disease (COPD), d.
             asthma

          -  Randomized to study intervention treatment within 72 hours after onset of any of the
             RSV symptoms or worsening of pre-existing symptoms

          -  Not be hospitalized during screening (emergency room or hospital observation status
             for an anticipated duration of less than [<] 24 hours are not considered as
             hospitalization)

        Exclusion Criteria:

          -  Known allergies, hypersensitivity, or intolerance to rilematovir or to any of the
             excipients of rilematovir or placebo formulation

          -  Presence of clinically significant heart arrhythmias, uncontrolled, unstable atrial
             arrhythmia, or sustained ventricular arrhythmia

          -  Participant has known or suspected (from medical history or participant examination)
             chronic or acute hepatitis B or C infection

          -  Immunocompromised conditions

          -  Living in institutional care or assisted living facility and also receiving acute care
             management for any respiratory condition