bioihbjkbjnl/mcl2 huggingface dataset:
Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: gemcitabine; paclitaxel
Intervention description: Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation)
Phase 2: dose determined by phase 1; Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: Female
Minimum age: 20 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients
      with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline
      regimen
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically and/or cytologically confirmed breast cancer

          -  Received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline
             regimen

          -  To have at least one measurable region

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1

          -  To have adequate organ function (bone marrow, liver and renal function)

        Exclusion Criteria:

          -  To have interstitial pneumonia or pulmonary fibrosis

          -  To have inflammatory breast cancer

          -  Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest
             hormonal/immunotherapy or 7 days after surgery

          -  To have brain metastases with symptoms

          -  To have severe complication (cardiac infarction, infection, drug hypersensitivity or
             diabetes)
Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
Condition: Asthma
MeSH terms: Asthma
Intervention: TD-8236; Placebo
Intervention description: The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.; The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: TD-8236; Asthma; Proof of concept

Summary:

      This will be a randomized, double-blind, placebo-controlled study. The study will use a
      three-period, six-sequence, complete-block, cross-over study design to characterize two doses
      of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to
      an allergen. Each of the three periods will be 14 days, followed by a washout period before
      the next period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 65 years of age

          -  Willing and able to give informed consent and comply with study requirements

          -  Documented physician-diagnosed asthma for ≥ 4 months prior to Screening

          -  Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening and weighs ≥ 50 kg at
             Screening.

          -  Women of child bearing potential must have a negative pregnancy test

          -  Males and females must use a highly efficient birth control method

          -  Pre-bronchodilator FEV1 ≥ 70% predicted

          -  Documented allergy to at least one common allergen

          -  Dual responder to inhaled bronchial challenges

          -  Additional inclusion criteria apply

        Exclusion Criteria:

          -  Positive for hepatitis A, B or C, HIV or tuberculosis

          -  Clinically significant abnormalities of laboratory evaluations

          -  Have abnormal ECG measurements

          -  Any sign of respiratory tract infection within 6 weeks of screening

          -  Have a current bacterial, parasitic, fungal or viral infection

          -  History of life-threatening asthma

          -  Uses or have used tobacco or nicotine-containing products within 6 months prior to
             screening

          -  Additional exclusion criteria apply
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Intervention: Levothyroxine sodium new formulation
Intervention description: Levothyroxine tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The purpose of this study is to investigate the effect of switching participants taking
      levothyroxine to a new sodium formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          1. (Near) total thyroidectomised patients.

          2. Aged 18 years and older.

          3. Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks
             before inclusion in the study.

          4. Written informed consent given.

          5. Able and willing to comply with protocol requirements and to complete the study.

        Exclusion Criteria:

          1. History of Graves' disease or positive TSH-receptor antibodies.

          2. History of thyroid cancer requiring TSH suppression.

          3. Medical procedures or treatments planned that could influence the thyroid hormone
             state of the patients during this trial.

          4. Use of levothyroxine containing medicines provided by other brands to treat
             hypothyroidism.

          5. Pregnant or planning pregnancy. Female patients of childbearing potential need to
             apply highly effective methods of birth control.

          6. Participation in another trial in the past 6 weeks.

          7. Exclusion criteria during the study are the occurrence of any serious adverse
             reaction, any laboratory or clinically relevant change in patient status, any change
             in smoking status, use of drugs non-authorized by the physician (to avoid relevant
             drug interactions) and lack of patient compliance with the study drug. (OR events not
             considered as exclusion criteria but to be documented in the case report form, as a
             possible explanation for change in lab parameters and/or dose switch).
Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
Condition: Choroidal Neovascularization; Wet Macular Degeneration
MeSH terms: Macular Degeneration; Choroidal Neovascularization; Wet Macular Degeneration; Neovascularization, Pathologic
Intervention: ICON-1; aflibercept
Intervention description: ICON-1 0.6 mg by intravitreal injection; aflibercept 2 mg by intravitreal injection
Intervention MeSH terms: Aflibercept; Immunoconjugates
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effects of repeated intravitreal
      injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with
      aflibercept in patients with wet macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females of any race, ≥50 years of age

          -  Active primary CNV secondary to AMD in the study eye

        Exclusion Criteria:

          -  Any prior treatment of CNV or advanced AMD in the study eye, except for dietary
             supplements or vitamins

          -  Any intraocular or ocular surface surgery (including cataract surgery and laser
             procedures) in the study eye within 3 months

          -  Vitrectomy in the study eye
Soy Protein and Breast Cancer Risk Reduction
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: soy milk; cow's milk
Intervention description: Each drink contained soy protein, fat, and carbohydrates calcium and phosphorous to give a total energy of 177.8 kcal. Subjects took two drinks per day.; Each drink contained casein, fat, carbohydrates, calcium and phosphorous to give a total energy of 178.6 kcal. Subjects took two drinks per day.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo controlled, 2 parallel groups
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Research pharmacist dispensed blinded assigned sachets according to a pre-generated randomization list. Pharmacists were blinded to all other aspects of the research protocols.
Subjects, investigators, research staff, and statisticians were all blinded to treatment assignment.
Enrollment: 321.0
Sex: Female
Minimum age: 30 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: soy diet; breast cancer; ovarian hormones; breast density; prevention

Summary:

      Soy consumption has been associated with reduced risk for developing breast cancer. Ovarian
      hormones and breast density are considered breast cancer risk markers. We propose to test the
      hypothesis that consumption of soy protein reduces ovarian steroid hormones and results in a
      corresponding reduction in breast density comparing to casein protein.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy premenopausal women

          -  30 to 40 years old

          -  normal mammograms

          -  regular menstrual cycles

        Exclusion Criteria:

          -  abnormal mammograms

          -  first degree relatives with breast cancer

          -  pregnant or lactating

          -  peri- or post-menopause

          -  breast augmentation, reduction, and lifting

          -  on oral contraceptive medications or exogenous hormones

          -  medically prescribed diets

          -  allergic reaction to soy or cow's milk
Baclofen Effects on Smoking Urge and Withdrawal
Condition: Nicotine Use Disorder; Nicotine Dependence; Smoking; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Baclofen; Placebo
Intervention description: Dosing taken orally for a total of 12 days: 40mg/day vs. 0mg/day (placebo tabs). The 40mg condition will receive 15mg/day the first 3 days(Days 1,2,3), 30mg/day for 3 days(Days 4,5,6), and 40mg/day for 3 days(Days 7,8,9). Downward titration: 40mg/day condition will receive 40mg/day(Day 10), 20mg/day(Day 11), and 10mg/day(Day 12).; Matched placebo capsules containing inert filler taken orally for a total of 12 days
Intervention MeSH terms: Baclofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Baclofen; Conditioning, Classical; Nicotine; Smoking

Summary:

      The purpose of this study is to determine whether baclofen is effective in reducing smoking
      urge, withdrawal, and reinforcement in moderate to heavy cigarette smokers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Smoke at least 10 cigarettes per day for at least 6 months and considering quitting
             smoking in the next 6 months-

        Exclusion Criteria:

          -  Planning to attempt smoking cessation within the next 4 months

          -  Weight less than 110 lbs. or above 220 lbs.

          -  Use of tobacco products other than cigarettes in the previous month.

          -  History of: Kidney disease, uncontrolled conditions (e.g., cardiac disease, pulmonary
             disease, diabetes, hypertension) Neurological disease (including stroke, mini-stroke,
             brain injury, Alzheimers Disease, encephalitis, meningitis, seizure
             disorder),Phenylketonuria Schizophrenia, Schizoaffective Disorder, Paranoid Disorder,
             or Schizotypal Disorder.

          -  Current alcohol and/or drug use disorder as indicated by a screening questionnaire,
             past treatment for alcohol or substance use problems unless in remission(clean and
             sober for past year or more) or intention to seek treatment in the next 6 months for
             alcohol or substance use problems.

          -  For women: Pregnancy, nursing, not using a reliable form of birth control.

          -  Allergy to baclofen, Lioresal, or Kemstro.

          -  Taking the following medications: antidepressants(excluding selective serotonin
             reuptake inhibitors), bupropion, phenothiazines, antihistamines, sedative/hypnotics,
             benzodiazepines, alpha blockers, beta blockers.

          -  Lives with someone enrolled in the study.
Safety and Efficacy of Exendin 9-39 in Patients With Postbariatric Hypoglycemia
Condition: Postbariatric Hypoglycemia
MeSH terms: Hypoglycemia
Intervention: exendin 9-39; Placebo
Intervention description: Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.; Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This clinical study will evaluate whether taking an investigational drug called exendin 9-39
      is safe, well-tolerated, and helps to prevent low blood sugar in people who have had
      bariatric surgery and later develop a rare condition called postbariatric hypoglycemia (PBH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of up to 40 kg/m2

          -  Roux-en-Y gastric bypass (RYGB) surgery performed ≥12 months prior

          -  Diagnosis of PBH

          -  At least 2 episodes during screening 2-week run-in phase of severe hypoglycemia

        Exclusion Criteria:

          -  Other cause of endogenous hyperinsulinism other than PBH

          -  Metabolic or bariatric surgical procedure other than RYGB

          -  History of non-RYGB upper GI surgery

          -  Use of agents that may interfere with glucose metabolism
Liposome Bupivacaine Interscalene Total Shoulder
Condition: Acute Pain
MeSH terms: Acute Pain
Intervention: liposome bupivacaine; Bupivacaine
Intervention description: interscalene block with liposomal bupivacaine plus bupivacaine; interscalene block with bupivacaine
Intervention MeSH terms: Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a randomized prospective outcomes study comparing two groups of patients. One group
      will receive liposomal bupivacaine plus bupivacaine and the other will receive bupivacaine
      alone in interscalene blocks when undergoing total shoulder arthroplasty. The purpose of the
      study is to determine if LB plus bupivacaine provides superior pain control compared to
      bupivacaine alone when injected in an interscalene block for patients undergoing total
      shoulder arthroplasty surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All adult patients aged greater than 18 years of age that are undergoing total or
             reverse total shoulder arthroplasty

        Exclusion Criteria:

          -  Patients with allergy to local anesthetics, daily use of opioids for more than 3 weeks
             prior to surgery, patient refusal, patient with coagulopathy, non-english speaking
             patients, and those who do not have access to a telephone.
A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Follicular
Intervention: Parsaclisib
Intervention description: Parsaclisib tablets administered orally with water and without regard to food
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Follicular lymphoma; non-Hodgkin lymphoma (NHL); phosphatidylinositol 3-kinase (PI3K) δ inhibitor

Summary:

      The purpose of this study is to assess the objective response rate of parsaclisib treatment
      in participants with relapsed or refractory follicular lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged 18 years or older.

          -  Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin
             lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.

          -  Ineligible for hematopoietic stem cell transplant.

          -  Must have been treated with at least 2 prior systemic therapies.

          -  Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined
             as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥
             1.0 cm in the longest perpendicular dimension as assessed by computed tomography or
             magnetic resonance imaging.

          -  Must be willing to undergo an incisional, excisional, or core needle lymph node or
             tissue biopsy or provide a lymph node or tissue biopsy from the most recent available
             archival tissue.

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

        Exclusion Criteria:

          -  Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.

          -  History of central nervous system lymphoma (either primary or metastatic).

          -  Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta
             (PI3Kδ) inhibitors, or a pan-PI3K inhibitor.

          -  Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).

          -  Allogeneic stem cell transplant within the last 6 months, or autologous stem cell
             transplant within the last 3 months before the date of study treatment administration.

          -  Active graft-versus-host disease.

          -  Participants positive for hepatitis B surface antigen or hepatitis B core antibody
             will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid
             (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be
             eligible if they are negative for HCV-ribonucleic acid (RNA).
Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis; Kidney Failure, Chronic
Intervention: LDV/SOF
Intervention description: 90/400 mg fixed- dose combination (FDC) tablet administered orally once daily
Intervention MeSH terms: Sofosbuvir; Ledipasvir, sofosbuvir drug combination; Ledipasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the safety, efficacy and tolerability of
      treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are
      on dialysis for ESRD.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV infected genotype 1, 2 (Taiwan only), 4, 5, or 6 male and nonpregnant/
             nonlactating females aged 18 years or older who are on dialysis for ESRD, including
             adults with HIV coinfection if they are suppressed on a stable, protocol-approved
             antiretroviral (ARV) regimens for ≥8 weeks prior to screening.

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Buprenorphine transdermal patch; Buprenorphine transdermal patch; Buprenorphine transdermal patch; Placebo BTDS
Intervention description: Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.; Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.; Buprenorphine transdermal patches 10 mcg/h and 20 mcg/h (total of 30 mcg/h) applied for 7-day wear.; Placebo to match BTDS transdermal 10 and 20 patches applied for 7-day wear.
Intervention MeSH terms: Buprenorphine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Postoperative pain; opioid; transdermal; TKA (total knee arthroplasty)

Summary:

      The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal
      system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2)
      the impact of BTDS on functional rehabilitative measures after total knee replacement
      surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind
      treatment period is for 28 days during which time supplemental analgesic medication will be
      provided to all subjects in addition to study drug.

      Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to
      efficacy or safety. The focus of this study became safety evaluations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females of 18 to 80 years of age with American Society of Anesthesiologists
             (ASA) physical status classification of 1, 2 or 3

          -  Scheduled to undergo unilateral total knee arthroplasty (TKA) for the treatment of the
             osteoarthritis.

        Exclusion Criteria:

          -  Subjects who have pain or disability in a site other than the operative joint.

          -  Subjects who have had total knee arthroplasty within 6 months of the scheduled surgery
             or are scheduled to undergo bilateral knee arthroplasty.

          -  Subjects whose body mass index (BMI) is 40 or more.