bioihbjkbjnl/mcl2 huggingface dataset:
Acceptability of Pharmacologic Treatment for Methamphetamine Dependence Among MSM
Condition: Substance Abuse; HIV Infections
MeSH terms: Substance-Related Disorders
Intervention: Bupropion; Placebo
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Methamphetamine; HIV

Summary:

      Studies demonstrate that methamphetamine (meth) use is associated with high-risk sexual
      behavior among MSM, putting meth-using MSM at extraordinarily high risk for transmitting or
      acquiring HIV. No studies have tested the feasibility and acceptability of conducting
      pharmacologic interventions to reduce meth use and meth-associated sexual risk behavior among
      MSM. The purpose of this pilot study is to determine the feasibility enrolling and retaining
      meth-dependent MSM into a pharmacologic study of bupropion vs. placebo and measuring the
      tolerability of and adherence to medication among these participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-negative by rapid test or able to document HIV infection through healthcare
             provider's note or documentation of laboratory test;

          -  Reports anal sex with men in prior 3 months while using meth

          -  Diagnosed with meth dependence as determined by SCID

          -  Interested in stopping or reducing meth use

          -  Meth-positive urine on screening

          -  No known allergies to bupropion

          -  No current acute illnesses

          -  Able and willing to provide informed consent and to be followed over a 3-month period

          -  Baseline CBC and electrolytes within institutional limits.

        Exclusion Criteria:

          -  History of seizure

          -  High risk for seizure, including: recent (last 24 months) head trauma, brain injury or
             surgery; using theophylline or systemic steroids; prior or current history of anorexia
             or bulimia; prior or current history of alcohol withdrawal symptoms

          -  Measured moderate or severe liver disease (LFTs > 3 times normal) or history of
             chronic liver disease

          -  Impaired renal function (creatinine clearance < 90 ml/min)

          -  Evidence of current major depression, as determined by SCID

          -  Taking anti-depressant medication within last 30 days

          -  Currently on any bupropion-containing regimen

          -  Currently using or unwilling not to use pseudoephedrine-containing products (causes
             false + urines for meth use) for trial duration

          -  Currently taking antiretroviral therapy (ART)

          -  CD4 count < 200 cells/mm3

          -  Any condition that, in the principal investigator's judgment, interferes with safe
             study participation.
Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy
Condition: Ileostomy - Stoma
Intervention: Coloplast Test product; Standard Care
Intervention description: Coloplast test product is a newly developed 1-piece ostomy appliance; Standard care consists of three already marketed 1-piece ostomy products
Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse)
      in reducing leakage (4-point scale) compared to Standard of Care.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Have given written informed consent

          2. Be at least 18 years of age and have full legal capacity

          3. Be able to handle the appliance themselves or with help from caregiver (e.g. spouse)

          4. Have an ileostomy with a diameter between 15 and 45 mm

          5. Have had their ostomy for at least three months

          6. Currently use a 1-piece flat product with open bag

          7. Use minimum 1 product every second day.

          8. Be suitable for participation in the investigation and for using a standard adhesive,
             flat base plate

          9. Must use custom cut product

         10. Accept to test two 1-piece products within the study

        Exclusion Criteria:

          1. Use irrigation during the study (flush the stoma with water)

          2. Currently receiving or have within the past 2 months received radio- and/or
             chemotherapy

          3. Currently receiving or have within the past month received systemic steroid or local
             treatment in the peristomal area

          4. Are pregnant or breastfeeding

          5. Participating in other interventional clinical investigations or have previously
             participated in this investigation

          6. Has more than three days wear time
Sorafenib-induced Hand- Foot Skin Reaction Treatment
Condition: Hand-foot Skin Reaction; Rash
Intervention: urea 40% cream; fluocinonide 0.05% cream; tazarotene 0.1% cream; bland emollient cream (Udderly smooth® Udder Cream)
Intervention description: urea 40% cream applied twice per day to affected areas; fluocinonide 0.05% cream applied twice per day to affected areas; tazarotene 0.1% cream applied twice per day to affected areas; bland emollient cream applied twice per day to affected areas
Intervention MeSH terms: Fluocinonide; Tazarotene; Emollients
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sorafenib; rash; hand foot skin reaction

Summary:

      The purpose of this study is to evaluate treatments for a rash caused by sorafenib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients receiving sorafenib as monotherapy or in combination if other agents are not
             known to cause HFSR.

          -  Subjects must be 18 years or older.

          -  Patients must provide written informed consent to participate in the study.

          -  Women of childbearing potential and men must be willing to use an effective method of
             contraception while participating in this study and for at least two weeks after
             completing treatment in the study.

          -  Women in this study need to have a negative urine pregnancy test before starting study
             medications.

        Exclusion Criteria:

          -  Patients simultaneously taking another anti-cancer agent or combination of anti-cancer
             agents known to cause hand foot syndrome (pegylated doxorubicin, 5-fluorouracil,
             cytarabine).

          -  Patients with an active dermatological condition due to previous chemotherapy or
             biologic therapy affecting the hands.

          -  Patients with pre-existing dermatological condition affecting the hands or feet.

          -  Women who have a positive pregnancy test or are lactating.
An Extension Study to Assess the Long-Term Safety and Efficacy of Pasireotide in Participants With Acromegaly
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Pasireotide
Intervention MeSH terms: Pasireotide
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
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Acromegaly; Pasireotide; GH; IGF-1

Summary:

      Acromegaly is a rare, serious condition characterized by chronic hypersecretion of growth
      hormone (GH), generally caused by a GH-secreting pituitary adenoma. The study assessed the
      long-term safety and efficacy of pasireotide in participants with acromegaly.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have completed all four treatment regimens in the core study
             CSOM230B2201 (NCT00088582) and achieved biochemical control in growth hormone (GH) and
             insulin-like growth factor-1 (IGF-1) levels after at least one month of pasireotide
             administration at any of the three doses.

          -  Participants who did not experience any unacceptable adverse events or tolerability
             issues during the core study CSOM230B2201.

        Exclusion Criteria:

          -  Participants who experienced or developed compression of the optic chiasm causing any
             visual field defect during the core study CSOM230B2201.

          -  Participants who required a surgical intervention for relief of any sign or symptom
             associated with tumor compression during the core study CSOM230B2201.

          -  Participants who experienced or developed congestive heart failure, unstable angina,
             sustained ventricular tachycardia, ventricular fibrillation or acute myocardial
             infraction during the core study CSOM230B2201.

        Other protocol-defined inclusion/exclusion criteria may apply.
Effects of Co-administration of Canagliflozin 300 mg and Phentermine 15 mg With Placebo in the Treatment of Non-Diabetic Overweight and Obese Participants
Condition: Obesity
MeSH terms: Overweight
Intervention: Canagliflozin; Phentermine; Matching Placebo to Canagliflozin; Matching Placebo to Phentermine
Intervention description: 300 mg capsule, taken once daily, orally for 26 weeks.; 15 mg capsule, taken once daily, orally for 26 weeks.; Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.; Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
Intervention MeSH terms: Canagliflozin; Phentermine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 335.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Obesity; Overweight; Canagliflozin; Phentermine; INVOKANA®

Summary:

      The purpose of this study is to compare the effects of canagliflozin and phentermine to those
      of placebo to promote on a change in body weight over a 26 week period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have BMI >=30 kg/m2 and <50 kg/m2 at screening or BMI >=27 kg/m2 and <50 kg/m2 at
             screening in the presence of a comorbidity of hypertension and/or dyslipidemia

          -  Must have stable weight, ie, change of < =5% in the 3 months before screening

          -  Must agree to utilize a highly effective method of birth control

        Exclusion Criteria:

          -  An established diagnosis of diabetes mellitus

          -  Has a history of obesity with a known secondary cause (eg, Cushing's disease/syndrome)

          -  Has a history of hereditary glucose-galactose malabsorption or primary renal
             glycosuria

          -  Myocardial infarction, unstable angina, revascularization procedure, or
             cerebrovascular accident within 12 weeks before screening

          -  Has an Glycated hemoglobin (HBA1c) greater than or equal (>=) to 65 percent

          -  An average of 3 seated blood pressure (BP) readings of systolic BP >= 160 mm Hg and/or
             Diastolic BP >= 100 millimeters of mercury at screening
Hypoxic Changes in Hepatocellular Carcinoma (HCC) Following Trans Arterial Chemo Embolization and Stereotactic Radiation: Fluorine18 (18F) Fluoromisonidazole (FMISO) Imaging
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: FMISO; FMISO; FMISO
Intervention description: FMISO PET/CT imaging at baseline; FMISO PET/CT post TACE; FMISO PET/CT post SBRT
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      [18F] FMISO Positron Emission Tomography (PET) to determine hypoxia in patients with HCC
      treated with TACE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (> 18 years of age) patients with documented HCC tumor mass >3cm, who are
             scheduled to undergo TACE with additional selective internal radiation therapy (SIRT)

          -  The appropriate criteria for inclusion for this patient population are:

          -  Biopsy or radiological diagnosis of HCC (defined as Organ Procurement and
             Transplantation Network (OPTN*) Category 5 lesion either on CT or MRI)

          -  Scheduled for TACE (using doxorubicin-eluting beads) + SBRT

          -  Willingness to undergo PET/CT

          -  Able to lie on the imaging table for up to 1 hour.

          -  Able to provide signed informed consent.

          -  Women with childbearing potential must have a negative urine Beta-Human Chorionic
             Gonadotropin (β-hCG) test day of procedure

        Exclusion Criteria:

          -  Estimated life expectancy <12 months or serious medical co-morbidities that would
             preclude definitive local therapy

          -  Unable to lie on the imaging table

          -  Age less than 18 years.

          -  Pregnancy or lactation

          -  Inability or unwillingness to provide informed consent.

          -  Weight >500 lbs (the weight limit of the tomograph gantry table)
Study Evaluating The Effects Of Oprelvekin On Cardiac Repolarization In Subjects With Chemotherapy Induced Thrombocytopenia
Condition: Severe Thrombocytopenia
MeSH terms: Thrombocytopenia
Intervention: oprelvekin
Intervention description: injection, 50 mg/kg, once daily
Intervention MeSH terms: Oprelvekin
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: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is an open-label study in which oprelvekin will be administered for the prevention of
      severe low blood platelet cell counts (cells in your blood that keep bleeding and clotting
      stable) in adults with cancer who are taking chemotherapy (anti-cancer drug) that has a side
      effect of blocking your bone marrow from making platelet cells. The purpose of this study is
      to learn more about the effects of the recommended dose of oprelvekin on the heart's
      electrical cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women must be 18 to 65 years of age, with nonmyeloid malignancies for whom
             oprelvekin is indicated.

          -  At least one documented occasion of adequate hematologic recovery from previous or
             current chemotherapy.

          -  Adequate renal and hepatic excretory function.

        Exclusion Criteria:

          -  A marked baseline prolongation of QT/QTc interval (eg, repeated [two out of three
             readings] demonstration of a QTcF interval >450 msec.

          -  Additional risk factors for torsades de pointes including heart failure (subjects that
             have functional class III or IV congestive heart failure), hypokalemia,
             hypomagnesemia, or hypocalcemia.

          -  A pace maker or defibrillator.

          -  A history of LQTS, syncope, seizure, or the unexplained cardiac-related death of a
             family member at less than 30 years of age.

          -  Requirement of concomitant prescription or non-prescription medications or dietary
             supplements that have a risk of causing torsades de pointes or prolonged QT/QTc
             interval.
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
Condition: Clostridium Difficile Associated Disease
MeSH terms: Clostridium Infections
Intervention: Clostridium difficile Vaccine; Placebo
Intervention description: 0.5 mL intramuscular injection.; 0.5 mL intramuscular injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Clostridium difficile, Vaccine.

Summary:

      This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85
      years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination
      schedules. The study will assess the safety and tolerability of the vaccine as well as the
      subjects' immune response to the vaccine. One year after the third dose subjects that did not
      receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up
      to 4 years after their third vaccination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects

          -  Aged 65 to 85 years

        Additional Inclusion Criteria for the extension Stage:

          -  Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in
             the original portion of the study.

        Exclusion Criteria:

          -  Proven or suspected prior episode of Clostridium difficile associated diarrhea

          -  Unstable chronic medical condition

          -  Disease requiring significant change in therapy or hospitalization for worsening
             disease within 8 weeks before receipt of study vaccine

          -  Serious chronic disorders

          -  Congenital or acquired immunodeficiency disorders

          -  Rheumatologic disorders or other illnesses requiring chronic treatment with known
             immunosuppressant medications.

          -  Active or treated leukemia or lymphoma or bone marrow disorder

          -  Any contraindication to vaccination or vaccine components including previous
             anaphylactic reaction to any vaccine or vaccine-related components

        Additional Exclusion Criteria for the Extension Stage:

          -  Subjects originally randomized to placebo during the original portion of the study.

          -  Subjects who have already completed Visit 9 prior to study unblinding.
DS-8201a in Human Epidermal Growth Factor Receptor2 (HER2)-Expressing Colorectal Cancer (DESTINY-CRC01)
Condition: Colorectal Neoplasm
MeSH terms: Colorectal Neoplasms
Intervention: DS-8201a
Intervention description: DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration
Intervention MeSH terms: Trastuzumab; Trastuzumab deruxtecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Oncology; HER2; Colorectal cancer; Antibody drug conjugate; ADC

Summary:

      The main objective of this study is to test the safety and effectiveness of DS-8201a for
      participants with HER2-expressing advanced colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has pathologically documented unresectable, recurrent, or metastatic colorectal
             adenocarcinoma (until sponsor's notification to the study sites, subject must be a
             RAS/BRAF wild-type cancer)

          -  Has received at least 2 prior regimens of standard treatment

          -  Has measurable disease assessed by the investigator based on RECIST version 1.1.

          -  Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1

        Exclusion Criteria:

          -  Has a medical history of myocardial infarction within 6 months, symptomatic congestive
             heart failure

          -  Has a medical history of clinically significant lung disease

          -  Has spinal cord compression or clinically active central nervous system metastases,
             defined as untreated and symptomatic, or requiring therapy
Evaluate Low Doses of AEGR-733 on Hepatic Fat Accumulation by MRS
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: AEGR-733; placebo; AEGR-733; AEGR-733; AEGR-733; AEGR-733 and atorvastatin; AEGR-733 and fenofibrate; AEGR-733 and ezetimibe
Intervention description: 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period; 3 capsules each evening for each 4-week period
Intervention MeSH terms: Atorvastatin; Ezetimibe; Fenofibrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: LDL; hepatic fat

Summary:

      To determine safety and effectiveness of low-dose therapeutic AEGR-733 +/- atorvastatin,
      ezetimibe or fenofibrate (compared to placebo) on liver fat accumulation measured by Magnetic
      Resonance Spectroscopy
    

Eligibility criteria:

        Inclusion Criteria:

          1. LDL-C between 100 and 190 mg/dL

          2. Hepatic fat under 6.2% per MRS

        Exclusion Criteria:

          1. Pregnant or lactating females

          2. Uncontrolled hypertension >180/95 mmHg

          3. Chronic renal insufficiency - serum creatinine >2.5 mg/dL at screen

          4. Liver disease; i.e., hepatitis, cirrhosis

          5. Major surgery within 3 months of screen

          6. Cardiac insufficiency

          7. Hx of malignancy other than basal or squamous cell within past 5 yrs

          8. Participation in any investigational drug study within 6 wks of screen

          9. Prior exposure to AEGR-733 in past 12 months

         10. Serious or unstable medical or psychological conditions

         11. More than one alcoholic drink per day

         12. Regular consumption of grapefruit juice or meds known to be metabolized by CYP 3A4

         13. Currently taking corticosteroids

         14. Other lipid-lowering meds (washout permitted)

         15. Fish oil, niacin grater than 200 mg/day and herbal weight loss products (washout
             permitted)

         16. Acute CVD or event within previous 6 months

         17. Diabetes Mellitus

         18. Hepatitis B or C

         19. Medicated COPD

         20. Idiopathic pulmonary fibrosis

         21. G.I. disorders that cause chronic diarrhea

         22. Fasting triglycerides =/> 400 mg/dL

         23. Body Mass Index > 35kg/m2