bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Oral Fampridine-SR in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Placebo; 10 milligram (mg) fampridine-SR (4-aminopyridine, 4-AP); 15 mg fampridine-SR (4-aminopyridine, 4-AP); 20 mg fampridine-SR (4-aminopyridine, 4-AP)
Intervention description: Placebo for 15 weeks; 2 week up titration (10 mg)
12 weeks stable dose (10 mg)
1 week down titration (10 mg); 10 mg twice daily for 1 week
15 mg twice daily for 14 weeks
2 week up titration (10 mg x 1 week, 15 mg x 1 week)
12 weeks stable dose (15 mg)
1 week down titration (10 mg); 2 week up titration (10 mg x 1 week, 15 mg x 1 week)
12 weeks stable dose (20 mg)
1 week down titration (15 mg x 3 days, 10 mg x 4 days)
Intervention MeSH terms: 4-Aminopyridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Walking Ability; Muscle strength; Spasticity

Summary:

      Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the Central
      Nervous System (CNS). Normally, nerve fibers carry electrical impulses through the spinal
      cord, providing communication between the brain and the arms and legs. In people with MS, the
      fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates,
      causing nerve impulses to be slowed or stopped. As a result patients with MS may experience
      periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of
      coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the
      ability to think and/or remember. These periods of illness may come (exacerbations) and go
      (remissions). Fampridine-SR (Sustained Release, SR) is an experimental drug that increases
      the ability of the nerve to conduct electrical impulses. This study will evaluate the effects
      of Fampridine-SR on the walking ability of subjects with MS, as well as to examine the
      effects on muscle strength and spasticity. The study will also examine the possible risks of
      taking Fampridine-SR.
    

Eligibility criteria:

        INCLUSION CRITERIA:

          -  Have a confirmed diagnosis of Multiple Sclerosis

          -  Are able to walk with or without an assisted device

        EXCLUSION CRITERIA:

          -  Pregnancy, breastfeeding or females of childbearing potential not using adequate birth
             control

          -  Participating in other investigational drug trials

          -  A medical history or clinical findings that preclude entry into the study

          -  A medication history that precludes entry into the study

          -  Previously treated with 4-aminopyridine (4-AP)
Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy
Condition: Cerebral Amyloid Angiopathy
MeSH terms: Cerebral Amyloid Angiopathy; Cerebral Amyloid Angiopathy, Familial; Amyloidosis
Intervention: Ponezumab; placebo
Intervention description: Infusion of Ponezumab (Day 1=10mg/kg; Day 30 and Day 60 dose = 7.5mg/kg) or placebo (saline); administered via infusion for a total infusion time of 20 minutes.; placebo (saline)- given via infusion total infusion time of 20 minutes
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Cerebral amyloid angiopathy (CAA); cerebrovascular reactivity; functional MRI; randomized; double blind; safety; efficacy

Summary:

      Cerebral Amyloid Angiopathy (CAA) is a condition caused by the build-up of a protein called
      amyloid, predominantly Aβ40, within the walls of brain blood vessels, especially those blood
      vessels in the occipital lobe of the brain. Probable CAA may be defined as two or more
      hemorrhages in the brain cortex in individuals 55 years of age or older. This study will
      examine the study drug (PF-04360365) vs. placebo (saline) at 10 mg/kg - Day 1 and the
      maintenance dose of the study drug (PF-04360365) vs. placebo (saline) at 7.5mg/kg on Days 30
      and 60. Subjects will be followed for 6 months after receiving the last dose of study
      medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with probable CAA using the Boston criteria; with no clinical
             cognitive impairment

          -  In general good health

        Exclusion Criteria:

          -  Co-morbid diagnosis of clinically documented Alzheimer's disease or significant
             cognitive impairment

          -  Clinically significant syncope, epilepsy, head trauma or clinically significant
             unexplained loss of consciousness within the last 5 years

          -  Subject's body weight exceeding 100kg

          -  Women of childbearing potential.
HCT+F vs. HCT Alone in Critically Ill Medical Septic Shock Patients
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Intervention: Hydrocortisone
Intervention description: Hydrocortisone 50 mg IV Q6h
Intervention MeSH terms: Hydrocortisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will be conducted as a single-center, prospective, open-label, randomized trial
      that will evaluate adult patients admitted with septic shock to the medical critical care
      unit (MCC). The objective of the study is to determine if the use of hydrocortisone plus
      fludrocortisone is associated with a faster resolution of shock (defined as 24 hours
      vasopressor free) when compared to the use of hydrocortisone alone in medical, critically ill
      septic shock patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Critically ill medical patients requiring addition of stress dose steroid therapy
             (hydrocortisone) in addition to pressors for septic shock management during ICU stay

          -  Fludrocortisone administered within 24 hours after initiation of hydrocortisone if in
             combination therapy group

        Exclusion Criteria:

          -  Use of fludrocortisone and/or hydrocortisone for any reason other than septic shock
             management during ICU stay

          -  Fludrocortisone/hydrocortisone initiated by any service other than critical care
             medicine

          -  Prior use of fludrocortisone/hydrocortisone at time of admission (home or outside
             facility)

          -  Patients not appropriate for study inclusion as determined by provider discretion

          -  Patients receiving steroid therapy not in accordance with assigned group per location
             (MCC1 or MCC2)

          -  Patients re-admitted to the MCC during the same admission and restarted on vasopressor
             therapy will be noted during data collection and only the initial admission will be
             included for analysis

          -  Any patient receiving greater than one dose of hydrocortisone 100 mg

          -  Physical or medical contraindication to receiving PO or PER FT (per feeding tube)
             fludrocortisone
A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
Condition: Epithelial Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; High Grade Serous Carcinoma; Endometrioid Adenocarcinoma
MeSH terms: Carcinoma; Fallopian Tube Neoplasms; Carcinoma, Ovarian Epithelial; Carcinoma, Endometrioid; Cystadenocarcinoma, Serous
Intervention: Rucaparib; Nivolumab
Intervention description: Oral rucaparib will be administered twice daily; IV nivolumab will be administered once every 4 weeks
Intervention MeSH terms: Nivolumab; Rucaparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PARP; PARPi; PARP inhibitor; ARIES; Opdivo; Rucaparib; Nivolumab; PD-1; BRCA; LOH; CO-338; Immunotherapy; BMS-936558; Clovis; Clovis Oncology; Rubraca

Summary:

      This is an open label Phase 2, 2-stage, 2-cohort study to evaluate rucaparib in combination
      with nivolumab in patients with high-grade serous or endometroid ovarian cancer.

      Patients entering the following cohorts must have BRCA mutational status confirmed by a
      central lab:

        -  Cohort A1: No BRCA mutation in tumor; high level of LOH (loss of heterozygosity)

        -  Cohort A2: BRCA mutation in tumor
    

Eligibility criteria:

        General Inclusion Criteria:

          -  ≥ 18 years of age

          -  Adequate organ function

          -  Life expectancy ≥ 16 weeks

          -  Women of childbearing potential must have a negative serum pregnancy test

          -  High-grade serous or endometrioid epithelial ovarian, fallopian tube, or primary
             peritoneal cancer

          -  Received 1 or 2 prior regimens, including ≥ 1 prior platinum-based therapy and have
             platinum-sensitive disease

          -  Relapsed/progressive disease (confirmed by radiologic assessment)

          -  Willing and able to have a biopsy of tumor at screening and after 4 weeks of
             treatment.

          -  Measurable disease (RECIST v1.1)- Cohort A1 only

          -  ECOG performance status of 0 to 1

        General Exclusion Criteria

          -  Active second malignancy

          -  Central nervous system brain metastases

          -  Evidence of interstitial lung disease, active pneumonitis, myocarditis, or history of
             myocarditis.

          -  Active, known or suspected autoimmune disease (eg, autoimmune hepatitis).

          -  Condition requiring systemic treatment with either corticosteroids

          -  Prior treatment with a PARP inhibitor or immune checkpoint inhibitor.

          -  Non-epithelial tumors (pure sarcomas) or ovarian tumors with low malignant potential
             (ie, borderline tumors) or mucinous tumors. Mixed Mullerian tumors/carcinosarcomas are
             allowed.
Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
Condition: Dementia With Lewy Bodies
MeSH terms: Dementia; Lewy Body Disease
Intervention: RVT-101 35 mg; RVT-101 70 mg; Placebo
Intervention description: once daily, oral, 35-mg tablets; once daily, oral, 35-mg tablets; once daily, oral, matching tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 484.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Dementia with Lewy bodies; Lewy bodies; intepirdine; RVT-101; dementia

Summary:

      This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients
      with dementia with Lewy bodies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject with probable DLB

          -  Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and
             Baseline

          -  Patient has the ability to comply with procedures for cognitive and other testing in
             the opinion of the investigator

          -  Patient has a reliable caregiver who is willing to report on the subject's status
             throughout the study

          -  Patients currently receiving therapy for DLB are eligible for enrollment

        Exclusion Criteria:

          -  Atypical clinical features or clinical course that would lead the investigator to
             conclude primary symptoms are more likely explained by an alternate dementia
             diagnosis.

          -  Any clinically relevant concomitant disease that, in the opinion of the investigator,
             makes the patient unsuitable for inclusion in the study.
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: SABER-Bupivacaine Treatment 1a; Placebo SABER-Bupivacaine Treatment 1b; Bupivacaine HCl Treatment 1c; SABER-Bupivacaine Treatment 2a; Placebo SABER-Bupivacaine Treatment 2b; Bupivacaine HCl Treatment 2c
Intervention description: 5.0 ml; 5.0 ml; 40 ml; 7.5 ml; 7.5 ml; 40 ml
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 115.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Postoperative pain; Local anaesthesia; Postoperative pain after open abdominal hysterectomy surgery

Summary:

      The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain
      control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and
      safety evaluations. The study duration consists of a screening period up to 14 days and a
      treatment period 14 days with a long term follow up visit at 6 months. The study will provide
      further data on the efficacy and safety of the product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A planned elective, abdominal hysterectomy

          -  Patients suitable for general anaesthesia

        Exclusion Criteria:

          -  Known clinically significant hepatic, gastrointestinal, renal, haematological,
             urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities

          -  Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances.
             History of cured localised malignancies is allowed (i.e. basal or squamous cell skin
             carcinoma, breast carcinoma or cervical carcinoma)

          -  Abnormal ECG

          -  Prolonged QT syndrome

          -  Current or regular use of analgesic medication for other indication(s)
A Phase II Study of Epstein-Barr Virus-Specific Immunotherapy for Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Carcinoma
MeSH terms: Epstein-Barr Virus Infections; Carcinoma; Nasopharyngeal Carcinoma
Intervention: Epstein-Barr Virus Specific Immunotherapy
Intervention MeSH terms: Immunomodulating Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epstein-Barr Virus; NPC; EBV; immunotherapy

Summary:

      The purpose of this research study is to determine how effective and how safe it is to give
      an Epstein-Barr Virus (EBV) immunotherapy product to participants with nasopharyngeal
      carcinoma (NPC) associated with EBV that has come back or spread to other parts of the
      participant's body. This is phase II study with the aim of establishing a baseline of
      efficacy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven NPC of an WHO grade, associated with EBV
             infection documented by the presence of EBER expression by in situ hybridization in
             the tumor. Positive EBER staining from another institution must be confirmed by
             pathology review at Brigham and Women's Hospital. Other confirmation of EBV-associated
             disease is acceptable, such as EBV DNA in situ hybridization, if EBER analysis is not
             adequate

          -  Incurable NPC

          -  Recovery from toxicity from any prior NPC therapy to grade 1 or better

          -  18 years of age or older

          -  Evaluable or measurable disease, according to modified RECIST

          -  ECOG Performance Status of 0 or 1

          -  Adequate bone marrow, liver and renal function as outlined in protocol

        Exclusion Criteria:

          -  Radiotherapy for primary NPC within 8 weeks of enrollment, or radiotherapy for any
             other reason within 6 weeks

          -  Chemotherapy for NPC within 2 weeks of enrollment

          -  Other cancer in the past 5 years, except for carcinoma in situ of the cervix or
             bladder, or non-melanomatous skin cancer

          -  Uncontrolled central nervous system metastases

          -  Active hepatitis, known HIV, or other condition that requires immunosuppressive
             therapy, including current use of high dose systemic corticosteroids

          -  Autoimmune disease, such as systemic lupus erythematosis or rheumatoid arthritis, that
             is active and requires current immunosuppressive therapy

          -  Active uncontrolled serious infection

          -  Women of child-bearing potential who have a positive pregnancy test or are
             breast-feeding
Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine
Condition: Migraine in Children
MeSH terms: Migraine Disorders
Intervention: Valproic Acid (VPA); Dihydroergotamine (DHE)
Intervention description: IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours; 0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
Intervention MeSH terms: Dihydroergotamine; Valproic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Valproic acid; Dihydroergotamine; Pediatric

Summary:

      The objective of this study is to compare clinical efficacy and tolerability of valproic acid
      (VPA) therapy versus dihydroergotamine (DHE) as abortive therapy in pediatric migraine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  acute migraine as per ICHD-II criteria

          -  pediatric (age 10-18)

        Exclusion Criteria:

        For Valproic Acid (VPA)

          -  Pregnancy

          -  Liver disease (Acute or Chronic)

          -  Urea Cycle Disorder

          -  Mitochondrial Disease

        For Dihydroergotamine (DHE)

          -  Pregnancy

          -  Peripheral vascular disease, coronary heart disease

          -  History of cerebrovascular event

          -  Severe or poorly controlled hypertension

          -  Impaired liver or renal function

          -  Triptan given in last 24 hours

          -  Hemiplegic migraine
A Study of Acne Treatment in Children Ages 9 to 11
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Retin-A Micro 0.04% facial acne treatment; Vehicle control
Intervention description: Retin-A Micro 0.04% facial acne treatment used once daily; Color-matched facial gel vehicle control used once daily
Intervention MeSH terms: Tretinoin; Benzoyl Peroxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 110.0
Sex: All
Minimum age: 9 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: acne; irritation; objective sensory methods

Summary:

      A study to determine if using Retin-A Micro 0.04% as facial acne treatment in patients ages 9
      to 11 is safe and efficacious.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and non-pregnant, non-nursing females, 9 to 11 years, with facial pediatric acne
             vulgaris

          -  Minimum of 20 non-inflammatory lesions (open and closed comedones)

          -  Minimum of 30 total facial lesions (sum of inflammatory and non-inflammatory)

          -  Must have at least a rating of grade 3 on the Investigator Global Assessment Scale for
             acne severity (IGA #1) at baseline

        Exclusion Criteria:

          -  Known sensitivity to any of the ingredients in the study medication;

          -  Any nodulocystic acne lesions

          -  Use of acne devices or systemic therapy with antibiotics within two months prior to
             start and throughout the duration of the study

          -  Use of systemic therapy with retinoids within four months prior to study start and
             throughout the duration of the study

          -  Topical use of topical retinoids within two weeks prior to study start and throughout
             the duration of the study

          -  Topical use of antibiotics, steroids and/or other non-retinoid topical acne products
             within two weeks prior to study start and throughout the duration of the study

          -  Use of an experimental drug or device within 60 days prior to study start;

          -  Use of hormonal therapy within 3 months prior to study start

          -  History of evidence of other skin conditions or diseases that may require concurrent
             therapy or may interfere with the evaluation of the study medication

          -  Any significant medical conditions that could confound the interpretation of the study

          -  History of/or current facial skin cancer

          -  Inability to refrain from use of all facial products other than those supplied by the
             study, while participating in the study

          -  No use of tanning booths, sun lamps, etc.

          -  Subject is a family member of the employee or the investigator