bioihbjkbjnl/mcl2 huggingface dataset:
Study of Adjunctive Ganaxolone Treatment in Female Children With Protocadherin 19 (PCDH19)-Related Epilepsy (Violet Study)
Condition: PCDH19-Related Epilepsy
MeSH terms: Epilepsy
Intervention: Ganaxolone; Placebo
Intervention description: active drug; inactive
Intervention MeSH terms: Pregnanolone; Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The double-blind phase will randomize subjects to adjunctive ganaxolone or placebo at a 1:1 ratio to standard of care.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 29.0
Sex: Female
Minimum age: 1 Year
Maximum age: 17 Years
Healthy volunteers: No
Keywords: refractory seizures; epilepsy in children; seizure disorder

Summary:

      A clinical study to evaluate the efficacy, safety, and tolerability of adjunctive ganaxolone
      therapy compared to placebo for the treatment of seizures in female children and young adults
      with genetically confirmed PCDH19 gene mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Molecular confirmation of a pathogenic or likely pathogenic PCDH19 variant

          -  Failure to control seizures despite 2 or more anti-seizure medications

          -  12 seizures over a 12-week period of primary seizure types prior to screening

          -  On a stable regimen of concomitant AEDs, Ketogenic diets, and modified Atkins diet
             should be unchanged for 3 months prior to screening)

        Exclusion Criteria:

          -  Previous exposure to ganaxolone

          -  > 8 consecutive weeks of seizure freedom during the 12 weeks prior to screening

          -  Concurrent use of strong inducers or inhibitors of CYP3A4/5/7 is not permitted

          -  Use of tetrahydrocannabinol (THC) or non-approved cannabidiol (CBD) is prohibited
             during the double-blind phase

          -  Exposure to any other investigational drug within 30 days or fewer than 5 half-lives
             prior to screening
Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease
Condition: Thyroid Associated Ophthalmopathies; Thyroid-Associated Ophthalmopathy
MeSH terms: Eye Diseases; Graves Ophthalmopathy; Thyroid Diseases
Intervention: teprotumumab; normal saline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Thyroid Eye Disease, Graves Orbitopathy, Thyroid Associated; Ophthalmopathy

Summary:

      The primary objective of this study is to investigate the efficacy, safety, and tolerability
      of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months,
      in comparison to placebo, in the treatment of participants suffering from active TED.

      "Funding Source - FDA OOPD"
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of Graves' disease associated with active TED and a clinical
             activity score of ≥ 4

          -  Fewer than 9 months from onset of TED

          -  No previous medical or surgical treatment, excluding local supportive measures and
             oral steroids if the maximum cumulative dose is less than 1000 mg methylprednisolone
             or equivalent with at least 6 weeks between last administration of oral steroids and
             randomization

          -  Euthyroid or with mild hypo or hyperthyroidism defined as free thyroxine (FT4) and
             free triiodothyronine (FT3) levels less than 50% above or below the normal limits
             (every effort should be made to correct the mild hypo- or hyperthyroidism promptly)

        Exclusion Criteria:

          -  Optic neuropathy

          -  Corneal decompensation unresponsive to medical management

          -  Oral or IV steroid treatment for any non-TED reason in the preceding 3 months

          -  Poorly controlled diabetes

          -  Platelets < 100 x 10^9/L

          -  Hemoglobin concentration > 2 g/dL below the lower limit of normal
Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
Condition: Obesity
MeSH terms: Obesity
Intervention: LIK066; Carbohydrate 50%; Carbohydrate 25%; Carbohydrate 8%; Carbohydrate 0%; Psyllium; Calcium carbonate
Intervention description: LIK066 50 mg tablets. Open-label, bulk, blister-pack.; 50% carbohydrate in breakfast meal; 25% carbohydrate in breakfast meal; 8% carbohydrate in breakfast meal; 0% carbohydrate in breakfast meal; Powder 6 grams; Liquid 1 gram (4 mL equivalent sugar free)
Intervention MeSH terms: Licogliflozin; Calcium Carbonate; Psyllium; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: obesity; overweight; body mass index; BMI; diarrhea

Summary:

      The purpose of this study was to determine if LIK066 taken with a meal containing low
      carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to
      assess the potential effects of supplements such as psyllium or calcium carbonate on
      alleviating diarrhea associated with LIK066.
    

Eligibility criteria:

        Inclusion Criteria:

          -  obese and overweight, BMI 25-50, HbA1C <10%

        Exclusion Criteria:

          -  Preexisting, clinically significant cardiovascular, liver, renal, or GI disease that
             is considered unstable; pregnancy, Type 1 diabetes; Other protocol-defined
             inclusion/exclusion criteria may apply
A Study of Atezolizumab as Neoadjuvant and Adjuvant Therapy in Resectable Non-Small Cell Lung Cancer (NSCLC) - Lung Cancer Mutation Consortium (LCMC3)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody
Intervention description: Atezolizumab was given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
Intervention MeSH terms: Atezolizumab; Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was designed to evaluate the safety and efficacy of neoadjuvant and adjuvant
      atezolizumab in participants with resectable Non-Small Cell Lung Cancer (NSCLC). Neoadjuvant
      therapy consisted of two 21-day cycles with atezolizumab. Following surgery, adjuvant therapy
      consisted of up to 12 months of atezolizumab in participants who demonstrate clinical benefit
      with neoadjuvant therapy. All participants who undergo surgery entered a surveillance period,
      which consisted of standardized blood sample collection and Chest CT Scans, for up to 2
      years. All participants were monitored for disease recurrence and survival for up to 3 years
      after last dose of study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically documented Stage IB, II, IIIA, or selected IIIB, including T3N2 or T4
             (by size criteria, not by mediastinal invasion) NSCLC

          -  Adequate pulmonary and cardiac function

          -  Available biopsy of primary tumor with adequate samples

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  NSCLC that is clinically T4 by virtue of mediastinal organ invasion or Stage IIIB by
             virtue of N3 disease

          -  Any prior therapy for lung cancer within 3 years.

          -  Prior treatment with anti-PD-1 or PD-L1 therapies

          -  History or risk of autoimmune disease
A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib
Intervention description: Erlotinib 150 mg tablet will be given orally daily.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm, open-label study will evaluate the efficacy and safety of erlotinib
      (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer
      (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic NSCLC with EGFR mutations

          -  Measurable disease according to RECIST criteria

          -  Adequate hematological, renal and liver function

        Exclusion Criteria:

          -  Previous chemotherapy or therapy against EGFR for metastatic disease

          -  Symptomatic cerebral metastases

          -  Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic
             carcinomatosis

          -  History of another malignancy except for carcinoma in-situ of the cervix, adequately
             treated basal cell skin carcinoma, or radically treated prostate carcinoma with good
             prognosis

          -  Concomitant use of coumarins
Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: anastrozole; fulvestrant
Intervention description: Given orally; Given intramuscularly
Intervention MeSH terms: Fulvestrant; Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Female
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer

Summary:

      RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using
      anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.
      Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Given
      the lack of clinical data on fulvestrant in patients with large operable or locally advanced
      hormone-receptor-positive breast cancer, and the potential to identify differences in the
      mechanism of resistance using the neoadjuvant model,we decided to perform a multicentre
      randomised phase II clinical trial of anastrozole and fulvestrant.

      PURPOSE: The aim of this study was to assess the efficacy of neoadjuvant anastrozole and
      fulvestrant treatment of large operable or locally advanced hormone-receptor-positive breast
      cancer not eligible for initial breast-conserving surgery, and to identify genomic changes
      occurring after treatment.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:

               -  SBR grade I-II disease (patients < 65 years of age)

               -  SBR grade I-III disease (patients > 65 years of age)

          -  T2 (2-5 cm), T3, or T4B, and N0-1 disease

          -  No metastatic disease

          -  Breast lesion not amenable to breast-conserving resection

          -  No inflammatory breast cancer

          -  No prior breast cancer

          -  Hormone receptor status:

               -  Estrogen receptor- and/or progesterone receptor-positive

        PATIENT CHARACTERISTICS:

          -  Postmenopausal

          -  No other cancer within the past 5 years except for adequately treated skin carcinoma
             or carcinoma in situ of the cervix

          -  No contraindication to anti-hormonal treatment

          -  No psychological, familial, social, or geographical reasons that would preclude follow
             up

        PRIOR CONCURRENT THERAPY:

          -  At least 8 days since prior hormone replacement therapy

          -  No concurrent anti-vitamin K treatment
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-126 Gel; IDP-126 Component A; IDP-126 Component B; IDP-126 Component C; IDP-126 Vehicle Gel
Intervention description: Gel; Component A; Component B; Component C; Vehicle Gel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 741.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group,
      Clinical Study in the Treatment of Acne Vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 9 years of age and older.

          2. Written and verbal informed consent must be obtained. Subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit).

          3. Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.

          4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 20, but no more than 100.

          5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count
             no less than 30, but no more than 150.

          6. Subjects with 2 or fewer facial nodules

        Exclusion Criteria:

          1. Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study.

          2. Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis,
             eczema.

          3. Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive.

          4. Subjects with a facial beard or mustache that could interfere with the study
             assessments.

          5. Subjects with more than 2 facial nodules.

          6. Evidence or history of cosmetic-related acne.
Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS
Condition: Pain, Acute
MeSH terms: Acute Pain
Intervention: S-Ibuprofen; Vehicle
Intervention description: Topical Gel 5%; Vehicle Gel
Intervention MeSH terms: Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: active gel and matching vehicle control gel
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel
      5%
    

Eligibility criteria:

        Inclusion Criteria:

          -  history of pain/soreness after exercise

          -  BMI between 18-30

          -  negative drug, alcohol, pregnancy screens

          -  other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  upper extremity workout in last 3 months

          -  job or hobby requiring heavy lifting

          -  history of muscle disorders

          -  allergy or intolerance to NSAID or study drug

          -  history of recent pain medication use

          -  other protocol-defined exclusion criteria may apply
Fecal Microbiota Transplantation for Pancreatitis
Condition: Acute Pancreatitis; Intestinal Bacteria Flora Disturbance; Intestinal Dysfunction; Fecal Microbiota Transplantation
MeSH terms: Pancreatitis
Intervention: Fecal Microbiota Transplantation; normal saline
Intervention description: FMT via a nasoduodenal tube with fresh bacteria from healthy donor; Normal saline via a nasoduodenal tube.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Severe acute pancreatitis; Fecal Microbiota Transplantation; Intestinal barrier dysfunction; Intestinal flora

Summary:

      The intestinal microbiota plays a pivotal role in the maintenance of intestinal homeostasis
      and protecting the gut against pathogens by competing for nutrients, creating the intestinal
      biological barrier and modulating the host immune system.After the onset of acute
      pancreatitis,the intestinal hypoperfusion and the release of inflammatory mediators result in
      intestinal barrier dysfunction and intestinal bacteria dysbiosis.This leads to Bacterial and
      endotoxin translocation, which may cause infectious complications which are major causes of
      death in SAP patients.Recently,FMT was shown its efficacy in the treatment of
      gastrointestinal(GI) diseases and non-GI disorders associated with Intestinal flora
      disturbance by re-establishing the damaged Intestinal Bacteria homeostasis.However,the
      mechanism by which FMT results in cure of diseases has been poorly understood.This study aims
      to investigate the therapeutic potential of FMT for SAP patients with intestinal barrier
      dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of acute pancreatitis from the First Affiliated Hospital of Nanchang
             University according to the Classification of acute pancreatitis-2012: revision of the
             Atlanta classification and definitions by international consensus

          2. Onset of pancreatitis within <=2 weeks

          3. complicated with gastrointestinal failure. Gastrointestinal failure was defined if the
             patients were complicated with obvious abdominal distention, abdominal rumbling sound
             weakening or disappearance, no self-defecation as well as intra-abdominal
             hypertension.

        Exclusion Criteria:

          1. SAP complicated by Gastrointestinal bleeding or Intestinal fistula

          2. Pregnancy and lactation women

          3. Not signed the informed consent

          4. Diabetes and autoimmune diseases

          5. Multiple organ failure. Organ failure was defined as a score of 2 or more using the
             modified Marshall scoring system including respiratory failure, renal failure and
             circulatory.
Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke
Condition: Stroke; Cerebrovascular Accident; Hemiparesis
MeSH terms: Stroke; Paresis
Intervention: Armodafinil; Placebo
Intervention description: inactive pill manufactured to mimic Armodafinil 150 mg tablet
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stroke; CVA; cerebrovascular accident; hemiparesis; impairment; motor recovery; neuroplasticity; nuvigil; armodafinil

Summary:

      Armodafinil is an FDA approved medication with wakefulness-promoting properties. It is a
      relatively safe agent with interesting neurochemical effects on the catecholamine system,
      producing an improvement in cognitive function, particularly working memory in humans. When
      combined with intensive task-related training, armodafinil may accelerate motor recovery in
      chronic stroke patients.

      The primary aim of this study is to determine whether administration of armodafinil during
      subacute post-stroke rehabilitation will augment cortical plasticity and enhance motor
      recovery. The primary hypothesis suggests that cortical plasticity will be enhanced by
      armodafinil and, therefore, will induce an improvement in motor function and better
      performances on measures of motor control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  First clinical stroke, either cerebral infarction or intracerebral hemorrhage

          -  Severe hemiparesis as measured by a Fugl-Meyer motor scale score of 0-25

          -  Screening Motricity Index score of 0-83

          -  Date of stroke onset between 7 to 21 days prior to study inclusion

        Exclusion Criteria:

          -  Age less than 18

          -  Previous clinical stroke

          -  Pregnant and/or nursing patients

          -  Major psychiatric history, including psychosis and history of substance abuse

          -  Dementia

          -  Known CNS pathology such as brain tumor

          -  Significant language dysfunction or severe neglect that hinders comprehension,
             participation, and barrier to testing

          -  Seizures

          -  Left ventricular hypertrophy (LVH)

          -  Mitral valve prolapse (MVP)

          -  Severe chronic renal failure or severe hepatic failure

          -  History or current use of anti-epileptic medications, psychostimulants, or
             neuroleptics

          -  Current use of diazepam, phenytoin, propranolol, tricyclic antidepressants, steroidal
             contraceptives, cyclosporine, or theophylline