bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Onabotulinumtoxin A (Botox) in Pediatric Patients Experiencing Migraines: A Study in the Pediatric Pain Population
Condition: Migraine Disorders; Headache, Migraine; Pediatrics
MeSH terms: Migraine Disorders; Headache
Intervention: OnabotulinumtoxinA; Placebo (Saline)
Intervention description: The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.; The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 8 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of the research is to examine the outcomes of pediatric patients receiving
      Botulinum toxin type A (Botox ®) for the treatment of migraine. There is limited literature
      on the effectiveness of Botox ® in the treatment of chronic neurological pain in pediatric
      patients, specifically in the treatment of migraines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 8 - 17 years of age with a history of migraine meeting the criteria
             established in ICHD-II (2004), Section 1. Patients will provide at least 28-day
             baseline data in the form in the daily diary and must have at least 15 days of
             reported headache during this period, with at least 4 distinct episodes lasting at
             least 4 hours each.

        Exclusion Criteria:

          -  Previous use of botulinum toxin of any serotype for any reason

          -  Pregnancy.

          -  Diagnosis of Myasthenia gravis, Eaton Lambert Syndrome, Amyotrophic Lateral Sclerosis

          -  Treatment of headache using acupuncture, transcutaneous electrical stimulation (TENS),
             cranial traction, dental splints, or injection of anesthetics/steroids within 4 weeks
             prior to the week of screening visit
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: TERN-101; Placebo
Intervention description: Investigational drug; Matching placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Farnesoid X receptor; NASH; Nonalcoholic Steatohepatitis; NAFLD; Nonalcoholic Fatty Liver Disease; FXR

Summary:

      This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate
      the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic
      NASH patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 75 years of age

          -  Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2

          -  Presumed NASH based on clinical characteristics or prior liver biopsy

          -  ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women

          -  MRI PDFF liver fat content ≥ 10 %

          -  Written informed consent

        Exclusion Criteria:

          -  History or clinical evidence of chronic liver diseases other than NAFLD

          -  History or clinical evidence of cirrhosis, hepatic decompensation or other severe
             liver impairment

          -  History of liver transplant, or current placement on a liver transplant list

          -  Total bilirubin > 1.2 mg/dL

          -  Albumin < 3.5 g/dL

          -  INR > 1.1

          -  AST or ALT > 5 x ULN

          -  ALP > 156 IU/L

          -  Platelet count < 150,000 /mm3

          -  eGFR < 60 mL/min/1.73m2

          -  Weight loss > 5% within past 3 months prior to Screening

          -  Uncontrolled diabetes

          -  Uncontrolled hyperlipidemia

          -  Active COVID-19 infection

          -  Other protocol-defined inclusion/exclusion criteria could apply
An Investigational Immuno-therapy Study to Test Combination Treatments in Patients With Advanced Non-Small Cell Lung Cancer
Condition: Advanced Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Dasatinib; Relatlimab; Ipilimumab; BMS-986205
Intervention description: Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab; Relatlimab; Dasatinib; Linrodostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 295.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab, in combination with other
      therapies, is effective in patients with advanced Non-Small Cell lung cancer
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Advanced Non Small Cell Lung Cancer (NSCLC)

          -  Eastern Cooperative Oncology Group (ECOG) Performance status of ≤ 1

          -  Life expectancy of at least 3 months from most recent chemotherapy or immunotherapy
             treatment

          -  Must have at least 1 lesion with measurable disease

        Exclusion Criteria:

          -  Subjects with certain mutations that have not been treated with a targeted therapy
             prior to enrollment

          -  Subjects who need daily oxygen therapy

          -  People with autoimmune disease

        Other protocol defined inclusion/exclusion criteria could apply
A Clinical Trial to Compare Efficacy and Tolerability of Faslodex With Arimidex in Patients With Advanced Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: fulvestrant; anastrozole
Intervention description: 500 mg intramuscular injection; 1 mg oral tablet
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: 205.0
Sex: Female
Minimum age: 45 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: oncology; cancer; breast cancer

Summary:

      The purpose of this study is to compare the efficacy and tolerability of Faslodex
      (fulvestrant) with Arimidex (anastrozole) in postmenopausal women with hormone receptor
      positive advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed hormone receptor positive advanced breast cancer, postmenopausal women

        Exclusion Criteria:

          -  Previous treatment for advanced breast cancer (previous treatment for early breast
             cancer is allowed).
A Study of Baricitinib (LY3009104) in Participants With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Baricitinib; Placebo; Triamcinolone (Optional)
Intervention description: Administered orally; Administered orally; Administered topically
Intervention MeSH terms: Triamcinolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atopic Eczema

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of Baricitinib in
      eczema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have moderate-to-severe Atopic Dermatitis (AD), as determined by all of the following:

               1. EASI of 12 or more

               2. Greater than or equal to 10% of body surface area involvement

               3. Diagnosed with AD at least 2 years prior

          -  Have a history of inadequate clinical response to other eczema treatments

        Exclusion Criteria:

          -  Females who are pregnant or nursing

          -  Participants who do not agree to use adequate contraception

          -  Are currently experiencing or have a history of:

               -  Skin conditions such as psoriasis or lupus erythematosus

               -  Skin disease that requires frequent hospitalizations or intravenous treatment

               -  Compromised immunity

          -  Serious illness that could interfere with study participation, or a clinically
             important deviation in physical examination, vital sign measurements,
             electrocardiograms, or abnormalities on laboratory tests

          -  Currently experiencing or have a history of:

               -  Active or latent Tuberculosis or specific immunity disorders and infections

               -  Malignancy or lymphoproliferative diseases in the last 5 years (or cervical,
                  basal or squamous skin cancer re-occurrence in the last 3 years)

               -  Human Immunodeficiency Virus (HIV)

               -  Hepatitis B, Hepatitis C, or chronic liver disease

          -  Have received certain types of vaccinations
Estrogen in Postmenopausal Women With ER Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapy
Condition: Breast Cancer; Cancer of the Breast; Neoplasms, Breast
MeSH terms: Breast Neoplasms
Intervention: Estrace; Anastrozole
Intervention description: Estrace 10 mg three times daily will be administered for 3 months.; After 3 months of estrace, patients who do not have evidence of disease progression will then be switched to received Anastrozole 1 mg daily as long as their disease benefits from this treatment
Intervention MeSH terms: Anastrozole; Estradiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; Metastatic breast cancer; ER positive breast cancer; Hormonal therapy

Summary:

      This trial seeks to confirm the response rate for estrace treatment in a patients with
      hormone receptor positive metastatic breast cancer heavily pre-treated with modern endocrine
      therapies.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed estrogen and/or progesterone receptor-positive breast cancer
             metastatic breast cancer

          -  Clinically determined evaluable disease

          -  Post-menopausal woman

          -  Previous clinical benefit from prior anti-estrogen therapies and subsequent failure of
             at least 2 prior endocrine therapies.

          -  May have had chemotherapy for adjuvant &/or metastatic disease.

          -  May have had radiation therapy but not to the only site of disease.

          -  Ecog performance status </= 2.

          -  Life expectancy of > 6 months

        Exclusion Criteria:

          -  Chemotherapy or radiotherapy within 1 week of beginning treatment in the clinical
             trial

          -  Brain metastasis

          -  Prior history of or active thrombophlebitis, deep venous thrombosis or pulmonary
             embolus

          -  Current vaginal bleeding

          -  Hypercalcemia or hypocalcemia

          -  History of or active hepatic adenoma

          -  No other malignancies within the past 5 years with the exception of curatively treated
             basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Progressive Forms of Multiple Sclerosis
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: elezanumab; placebo
Intervention description: solution for infusion; solution for infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Progressive multiple sclerosis; Elezanumab; ABT-555

Summary:

      The purpose of this study is to evaluate the safety and efficacy of elezanumab in
      participants with progressive Multiple Sclerosis (PMS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary-progressive multiple sclerosis (PPMS) or non-relapsing
             secondary-progressive multiple sclerosis (SPMS) and no relapses for at least 24
             months.

          -  Evidence of physical disability according to Expanded Disability Status Scale (EDSS)
             or Timed 25-Foot Walk (T25FW) or 9-Hole Peg Test.

        Exclusion Criteria:

          -  Treatment with any of the following within the 6 months prior to Screening:
             natalizumab; cyclosporine; azathioprine; methotrexate; mycophenolate mofetil;
             intravenous immunoglobulin (IVIg); any interferon product; and intravenous (IV), oral,
             or intrathecal corticosteroids for the purposes of disease modification.

          -  Treatment with the following within 1 year prior to Screening: cyclophosphamide or
             alemtuzumab.
Vaccine Therapy Following Chemotherapy & Peripheral Stem Cell Transplantation in Treating Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: autologous tumor cell vaccine; keyhole limpet hemocyanin; sargramostim; adjuvant therapy
Intervention MeSH terms: Sargramostim; Keyhole-limpet hemocyanin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma

Summary:

      RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune
      response to kill cancer cells. Vaccine therapy may be an effective treatment for
      non-Hodgkin's lymphoma.

      PURPOSE: Phase II trial to study the effectiveness of vaccine therapy following chemotherapy
      and peripheral stem cell transplantation in treating patients who have non-Hodgkin's
      lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over 19 years of age

          -  Histologically proven grade I, II, or III follicular non-Hodgkin's lymphoma that
             failed induction therapy

          -  Minimal disease state at day 100 to 6 months post-transplantatio

               -  Lymph nodes smaller than 2 centimeters (cm)

               -  Less than 20% bone marrow involvement with lymphoma

               -  Uncertain complete remission, defined by greater than 75% reduction in the size
                  of the pre-transplantation mass not representing active disease

          -  Tissue sample safely accessible by biopsy, needle aspiration, or phlebotomy

             o Must have adequate circulating lymphoma cells

          -  Karnofsky greater than 70%

          -  Absolute neutrophil count greater than 1,000/mm^3 (No restrictions if study vaccine
             administered at 6 months after transplantation)

          -  CD4+ count greater than 200/microliter (No restrictions if study vaccine administered
             at 6 months after transplantation)

          -  Bilirubin less than 2.0 mg/dL (unless due to lymphomatous involvement)

          -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase
             (SGPT) less than 2 times normal (unless due to lymphomatous involvement)

          -  Creatinine no greater than 2.0 mg/dL

          -  Fertile patients must use effective contraception during and for 6 months after study
             participation

        Exclusion Criteria:

          -  Previously received no more than 2 high-dose chemotherapies before hematopoietic stem
             cell transplantation

          -  Not pregnant or nursing/negative pregnancy test
Safety and Efficacy of Gaseous Nitric Oxide on Venous Stasis Leg Ulcers
Condition: Venous Ulcers
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Intervention: Nitric Oxide - same dose 6 wks; Nitric Oxide modified treatment
Intervention description: 200ppm, 8hrs / day for 6 weeks NO gas in nitrogen delivered to a patch over the wound; 200ppm, 8hrs/day for 1 week, followed by 25ppm 8hrs/day for 5 weeks Gas is delivered to a patch over the wound
Intervention MeSH terms: Nitric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Nitric Oxide; Venous Leg Ulcers

Summary:

      This study will test the safety and efficacy of nitric oxide gas in the treatment of venous
      leg ulcers
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a venous stasis ulcer between the knee and the ankle.

          -  Ulcer duration must be 60 days or greater

        Exclusion Criteria:

          -  Has an ulcer that is deemed by the Investigator to be caused primarily by a medical
             condition other than venous insufficiency

          -  Suffers from diabetes mellitus with HbA1c ≥ 8%

          -  Suffers from clinically significant arterial disease

          -  Is pregnant, a nursing mother or a woman of child bearing potential who is not using
             an adequate form of contraception (or abstinent)

        The above is a partial list of the inclusion and exclusion criteria; however, other
        inclusion and exclusion criteria may apply.
Heart Failure and Peritoneal Ultrafiltration
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Intervention: Extraneal
Intervention description: Periotneal Dialysis
Intervention MeSH terms: Icodextrin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the study is to determine if the addition of peritoneal ultrafiltration to
      standard therapy in treatment-resistant severe heart failure patients will improve fluid
      balance and functional capacity such that they will spend less time in the hospital and have
      an improved ambulatory quality of life in comparison to patients who remain on standard
      therapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with congestive heart failure (CHF) who remain fluid overloaded despite
             standard treatment.

        Exclusion Criteria:

          -  Patients who have reversible CHF or have diseases or conditions that would
             contraindicate the use of peritoneal dialysis.
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: SOF; RBV; PEG; LDV; GS-9669; LDV/SOF
Intervention description: Sofosbuvir (SOF) tablets administered orally once daily; Ribavirin (RBV) capsules administered orally in a divided daily dose; Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly; Ledipasvir (LDV) tablets administered orally once daily; GS-9669 tablets administered orally once daily; LDV/SOF fixed-dose combination (FDC) tablet administered once daily
Intervention MeSH terms: Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 292.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PSI-7977; Sofosbuvir; GS-7977; GS-5885; GS-9669; FDC; ribavirin; RBV; Pegylated Interferon; PEG-IFN; Chronic Hepatitis C Infection; HCV; Hepatitis; Genotype 1; Genotype 2; Genotype 3; GT 1; GT 2; GT 3; Hemophilia

Summary:

      This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and
      without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in
      subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA ≥ 50,000 IU/mL

          -  Not co-infected with HIV

          -  Use of highly effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  History of any other clinically significant chronic liver disease

          -  Pregnant or nursing female or male with pregnant female partner

          -  History of significant drug allergy to nucleoside/nucleotide analogs.

          -  Participation in a clinical study within 3 months prior to first dose

          -  Positive result for significant drug use at Screening
A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian Cancer
Condition: Epithelial Ovarian Cancer; Extraovarian Peritoneal Cancer; Fallopian Tube Carcinoma
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Ontak
Intervention description: Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
Intervention MeSH terms: Denileukin diftitox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epithelial Ovarian Cancer; FIGO (International Fed of Gyn and Ob)Stage III or Stage IV; Extraovarian Peritoneal Cancer; Fallopian Tube Carcinoma Failing

Summary:

      This study tests whether denileukin diftitox will deplete regulatory T cells, boost
      tumor-specific immunity and treat epithelial ovarian cancer in patients who have failed, or
      who are ineligible for front line therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide informed consent

          -  Not on Immune modulating drugs

          -  Life expectancy less than 6 months

        Exclusion Criteria:

          -  Unable to tolerate phlebotomy

          -  Germ cell or stromal cell cancers of the ovaries

          -  Active autoimmune disease