bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: RVT-1401; Placebo
Intervention description: Subcutaneous administration of RVT-1401; Subcutaneous administration of Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Extension
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Blinded
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IMVT-1401

Summary:

      The purpose of the current study is to assess safety/tolerability and key pharmacodynamic
      (PD) effects that are considered to be associated with clinical benefit (reduction of total
      IgG and anti-AChR-IgG) in Myasthenia Gravis patients following treatment with RVT-1401 (also
      known as IMVT-1401) compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥ 18 years of age.

          2. Myasthenia Gravis Foundation of America (MGFA) Class II-IVa and likely not in need of
             a respirator for the duration of the study as judged by the Investigator.

          3. QMG score ≥12 at Screening and Baseline.

        Other, more specific inclusion criteria are defined in the protocol.

        Exclusion Criteria:

          1. Use of rituximab, belimumab, eculizumab or any monoclonal antibody for
             immunomodulation within 6 months prior to first dosing.

          2. Immunoglobulins given by SC, IV (IVIG), or intramuscular route, or
             plasmapheresis/plasma exchange (PE) within 4 weeks before Screening.

          3. Thymectomy performed < 12 months prior to screening.

          4. Total IgG level <6 g/L (at screening).

          5. Absolute neutrophil count <1500 cells/mm3(at screening).

        Other, more specific exclusion criteria are defined in the protocol
Cetuximab-IRDye 800CW and Intraoperative Imaging in Finding Pancreatic Cancer in Patients Undergoing Surgery
Condition: Pancreatic Adenocarcinoma
Intervention: Cetuximab-IRDye800; Cetuximab
Intervention description: Administered intravenously (IV) at 50 or 100 mg; Administered as a 100 mg IV loading dose
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This phase 1-2 trial studies the side effects and best dose of cetuximab-IRDye 800CW when
      used with intraoperative imaging, to determine the utility of cetuximab-IRDye 800CW to
      identify and assess pancreatic cancer in patients undergoing surgery to remove the tumor.
      Cetuximab-IRDye 800CW may help doctors better identify cancer in the operating room by making
      the cancer visible when viewed through a fluorescent imaging system.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Clinically suspected or biopsy confirmed diagnosis of pancreatic adenocarcinoma

          -  Planned standard of care surgery with curative intent for pancreatic adenocarcinoma

          -  ≥ 19 years of age

          -  Life expectancy of more than 12 weeks

          -  EITHER

               -  Karnofsky performance status of at least 70%, OR

               -  Eastern Cooperative Oncology Group (ECOG)/Zubrod level 1

          -  Hemoglobin ≥ 9 gm/dL

          -  Platelet count ≥ 100,000/mm^3

          -  Magnesium > the lower limit of normal (LLN) per institution normal lab values

          -  Potassium > LLN

          -  Calcium > LLN

          -  Thyroid-stimulating hormone (TSH) < 13 micro International units/mL

        EXCLUSION CRITERIA

          -  Received an investigational drug within 30 days prior to first dose of cetuximab
             IRDye800

          -  Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive
             heart failure (CHF); or unstable angina within 6 months prior to enrollment

          -  History of infusion reactions to cetuximab or other monoclonal antibody therapies

          -  Pregnant or breastfeeding

          -  Evidence of QT prolongation on pretreatment electrocardiography (ECG) (greater than
             440 ms in males or greater than 450 ms in females)

          -  Lab values that in the opinion of the primary surgeon would prevent surgical resection

          -  Patients receiving class IA (quinidine, procainamide) or class III (dofetilide,
             amiodarone, sotalol) antiarrhythmic agents
Statin/Vitamin D & Migraine Study
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Simvastatin; Vitamin D; Placebo
Intervention description: simvastatin, 20 mg, twice daily for 6 months; Vitamin D3, 1000 IU, twice daily for 6 months; Two placebo pills, taken twice daily for 6 months
Intervention MeSH terms: Vitamin D; Simvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 89.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Migraine disorders; Headache; Simvastatin; Vitamin D

Summary:

      The investigators are studying if taking simvastatin and vitamin D together will help prevent
      episodic migraines. Simvastatin is an FDA approved drug that is typically used to treat high
      cholesterol and reduce the risk of stroke and heart attack. Vitamin D is a vitamin found in
      certain foods like some types of fish, and in nutritional supplements. This study is 9 months
      long. Some people who participate will receive simvastatin and vitamin D, and some people
      will receive a placebo. A placebo is a "sugar pill" that looks like medication but does not
      have any active ingredients in it.

      The investigators hypothesize that taking vitamin D and simvastatin daily may reduce the
      number of migraines people who have episodic migraine get.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Have had migraines for at least 3 years

          -  Have between 4 and 15 migraines a month

          -  Able to speak and read the English language

        Exclusion Criteria:

          -  Women who are pregnant or nursing, or planning on becoming pregnant in the next 10
             months

          -  Individuals who have a had a heart attack, stroke, peripheral artery disease,
             atherosclerotic aortic disease, carotid artery disease, or diabetes

          -  individuals at high risk for cardiovascular disease
Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: Placebo; Mesalamine Granules 750 mg; Mesalamine Granules 1500 mg
Intervention description: placebo capsules once daily for 12 weeks; 750 mg mesalamine granules once daily for 12 weeks; 1500 mg mesalamine granules once daily for 12 weeks
Intervention MeSH terms: Mesalamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IBS; Diarrhea; IBS-D; Irritable Bowel Syndrome; Abdominal pain; Bloating

Summary:

      The purpose of this study is to determine the daily dose of mesalamine granules that will
      provide adequate relief from symptoms of IBS with diarrhea.
    

Eligibility criteria:

        Inclusion Criteria:

        Male or non-pregnant, non-lactating female subjects Diagnosed with IBS confirmed by the
        Rome III criteria

        Meet the following IBS symptom scores in all categories during the diary eligibility
        period:

          -  An average daily score of greater than or equal to 3 for abdominal pain

          -  An average daily score of greater than or equal to 3 for bloating

          -  An average daily score of 5 or greater for stool consistency using the Bristol Stool
             Scale

          -  Does not have adequate relief of IBS symptoms (weekly reported) over the past 7 days
             on the first day of screening and on the day of randomization

        Exclusion Criteria:

          -  Present with hard or lumpy stools (Type 1 or Type 2) on the Bristol Stool form Scale
             during the diary eligibility period

          -  history of inflammatory bowel disease

          -  has Type 1 or 2 diabetes

          -  pregnant or lactating

          -  history of HIV or hepatitis B or C
A Long Term Safety Study Of Lersivirine For The Treatment Of HIV-1 Infection In Subjects Who Have Completed Treatment With Lersivirine In Studies A5271015 And A5271022
Condition: HIV-1
MeSH terms: Infections
Intervention: lersivirine; lersivirine; efavirenz; lersivirine; lersivirine; etravirine
Intervention description: Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily; Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily; Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily; Lersivirine 750 mg tablets PO taken once daily + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI; Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI; Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI
Intervention MeSH terms: Efavirenz; Etravirine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study to assess long-term safety and efficacy of lersivirine in patients who have
      completed 96 weeks of treatment with lersivirine in studies A5271015 and A5271022.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must complete of 96 weeks of treatment with lersivirine (or comparator where
             required by local regulation) in one of the parent protocols (A5271015 or A5271022).

          -  Patients must have had a viral load less than 50 copies/mL at Week 84 of the parent
             protocol.

          -  For women who can have children, a negative urine pregnancy test at the Day 1 visit.

        Exclusion Criteria:

          -  Patients with any Grade 4 Division of AIDS toxicity (except for lipids and
             asymptomatic glucose elevations will not be included in this trial.

          -  Patients being treated with another investigational product or in another clinical
             trial, except the lersivirine parent protocols will not be included in this trial.
Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer
Condition: Advanced Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: TAS-109
Intervention description: 14-day continuous central intravenous infusion at a dose of 2.0 mg/m2/day followed by a 7-day rest period.
Number of cycles: until unacceptable toxicity or disease progression requires discontinuation.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate progression free survival primarily. The secondary
      objectives are to evaluate the antitumor activity, as assessed by objective tumor response,
      duration of clinical benefit, overall survival, and the safety profile of TAS-109
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed colorectal adenocarcinoma

          -  Received prior therapy, at least two regimens, containing a fluoropyrimidine,
             oxaliplatin, and irinotecan

          -  Have at least one measurable tumor, as defined by RECIST

          -  Must be capable of maintaining a central venous line access

        Exclusion Criteria:

          -  Had previous anti-tumor therapy in the 3 weeks prior to study entry

          -  Have not recovered from all toxicities (excluding alopecia) from prior therapy to
             baseline or ≤grade 1 prior to study entry

          -  Have another malignancy in the past 3 years except curatively treated non-melanoma
             skin cancer or carcinoma in situ of the cervix
Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer
Condition: Metastatic, Gastric or Gastro-oesophageal Junction, Cancer
Intervention: AZD8931; Placebo; Paclitaxel
Intervention description: 40 mg, oral dose twice daily; Placebo, oral dose twice daily; IV once weekly for 3 weeks followed by a week off.
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic Gastric Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status

Summary:

      The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus
      paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal
      junction, cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 years or older (20 years or older in Japan)

          -  Patients must have radiologically confirmed progression following 1st line
             fluoropyrimidine and platinum based treatment for metastatic gastric cancer (the date
             of progression and start of first line treatment to be captured on the database)

          -  Suitable for paclitaxel therapy.

          -  At least one lesion, not previously irradiated and not chosen for a mandatory fresh
             tumour biopsy during the study screening period, that can be accurately measured at
             baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and is
             suitable for accurate repeat assessment.

          -  Ineligible for trastuzumab treatment by local assessment. This should include IHC
             analysis to determine HER2 status with further testing by FISH/CISH when considered
             part of local practice. Eligible patients are defined as; HER2 IHC 0, HER2 IHC +1 and
             +2

        Exclusion Criteria:

          -  Have received more than 1 prior chemotherapy regimen for metastatic gastric cancer.
             (chemotherapy as adjuvant treatment is permitted).

          -  Any prior taxane therapy (at any time from diagnosis of gastric cancer)

          -  Any prior therapy with an inhibitor of ErbB1 (EGFR) or ErbB2 (HER2) (eg, lapatinib)

          -  Resting ECG with measurable QTc(F) interval of greater than 480 msec at 2 or more time
             points within a 24 hour period (see section 6.4.9.1 )

          -  Unresolved toxicity grater than CTCAE grade 2 (except alopecia) from previous
             anti-cancer therapy
A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Upadacitinib; Placebo
Intervention description: Tablet for oral use; Tablet
Intervention MeSH terms: Upadacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ABT-494; Atopic Dermatitis

Summary:

      The objective of this study was to evaluate the safety and efficacy of multiple doses of
      upadacitinib monotherapy versus placebo in the treatment of adults with moderate to severe
      atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the
             Hanifin and Rajka criteria) and onset of symptoms at least 1 year prior to Baseline.

          -  Moderate to severe atopic dermatitis defined by an Eczema Area and Severity Index
             (EASI) ≥ 16, body surface area (BSA) ≥ 10% and an Investigators Global Assessment
             (IGA) score ≥ 3 at the Baseline visit.

          -  Documented history (within 1 year prior to the screening visit) of inadequate response
             to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors
             (TCI), or for whom topical treatments are otherwise medically inadvisable (e.g.,
             because of important side effects or safety risks).

          -  Twice daily use of an additive-free, bland emollient for at least 7 days prior to
             Baseline.

        Exclusion Criteria:

          -  Prior exposure to any systemic or topical Janus kinase (JAK) inhibitor (including but
             not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib).

          -  Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI),
             prescription moisturizers or moisturizers containing additives such as ceramide,
             hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit.

          -  Prior exposure to dupilumab or exposure to systemic therapies for AD including
             corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4
             (PDE4)-inhibitors and mycophenolate mofetil within 4 weeks prior to Baseline.

          -  Prior exposure to any investigational systemic treatment within 30 days or 5
             half-lives (whichever is longer) of the Baseline visit or is currently enrolled in
             another clinical study.
Study of Elobixibat (A3309) in Patients With Chronic Idiopathic Constipation
Condition: Constipation; Chronic Constipation
MeSH terms: Constipation
Intervention: A3309
Intervention description: A3309 in three different dosage levels or placebo once daily for the duration of the study
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 190.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic idiopathic constipation; A3309

Summary:

      The purpose of this trial is to determine the efficacy and safety of A3309 administered to
      patients with chronic idiopathic constipation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient meets protocol specified criteria for constipation

          -  Patient has successfully completed study requirements with no clinically relevant
             findings for physical exam, ECG, laboratory tests and colonoscopy as applicable

        Exclusion Criteria:

          -  Medical history or medical condition that would not make the patient a good candidate
             for the study or limit the patient´s ability to complete the study

          -  Patient reports loose stools

          -  Patient has IBS with pain/discomfort as predominant symptom

          -  Patient needs medications prohibited as specified in the protocol
The Efficacy and Safety Study of Tung's Acupuncture for Polycystic Ovarian Syndrome
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Intervention: Tung's acupuncture; Cyproterone acetate/ethinylestradiol (CPA/EE)
Intervention description: The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).; Cyproterone acetate/ethinylestradiol (CPA/EE) contains 2mg cyproterone acetate (an anti-androgenic progestin) and 0.035mg ethinylestradiol (CPA/EE). The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).
Intervention MeSH terms: Cyproterone Acetate; Ethinyl Estradiol; Cyproterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study was a randomized, drug-controlled, and parallel group trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: acupuncture; LH/FSH; total testosterone (TT); polycystic ovarian syndrome(PCOS)

Summary:

      This study evaluates the efficacy and safety in improving ovarian function of polycystic
      ovarian syndrome in adults. Half of patients will receive Tung's acupuncture therapy, while
      the other half will receive Diane-35(CPA/EE) as the control group.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chinese;

          2. 18-45 years old;

          3. to meet the diagnostic criteria for polycystic ovary syndrome;

          4. no need for pregnancy in the next six months;

          5. volunteering to join this research and give informed consent prior to receiving
             treatment.

        Exclusion Criteria:

          1. hypertensive patients with blood pressure exceed 160/100 mmHg;

          2. a history of thrombosis,cerebrolvascular diseases, cancer, liver disease or liver
             dysfuction, hyperlipidemia, mental disorder, and severe infection;

          3. having taken any pharmacological treatments affecting reproductive endocrine system;

          4. having received acupuncture in the previous three months;

          5. smoking more than 15 cigarettes per day;

          6. having pacemakers, metal allergies or severe fear of acupuncture.