bioihbjkbjnl/mcl2 huggingface dataset:
HIV Testing & Womens Attitudes on HIV Vaccine Trials
Condition: HIV
Intervention: Message Sidedness
Intervention description: There are 16 pairs of messages varying in sidedness. Arm 1 is a no message control condition regarding HIV testing + a no message control condition regarding trial participation. Arm 2 is control + a 1-sided message. Arm 3 is control + a trivial 2-sided message. Arm 4 is control + a major 2-sided message. Arm 5 is a 1-sided message + a control. Arm 6 is a 1-sided message + a 1-sided message. Arm 7 is a 1-sided message + a trivial 2-sided message. Arm 8 is a 1-sided message + a major2-sided message. Arm 9 is a trivial 2-sided message + a control. Arm 10 is a trivial 2-sided message + a 1-sided message. Arm 11 is a trivial 2-sided message + a trivial 2-sided message. Arm 12 is a trivial 2-sided message + a major 2-sided message. Arm 13 is a major 2-sided message + a control. Arm 14 is a major 2-sided message + a 1-sided message. Arm 15 is a major 2-sided message + a trivial 2-sided message. Arm 16 is a major 2-sided message + a major2-sided message.
Phase: Phase 3
Study type: Interventional
Primary purpose: Health Services Research
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2031.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV Testing; Persuasion; Health Communication; Clinical Trials Participation; Attitudes toward Health; Diagnostic Tests; Behavioral Research; Intervention Studies

Summary:

      The purpose of this study is to test the effects of different persuasive informational
      messages on rates of rapid HIV testing and willingness to participate in a HIV vaccine
      clinical trial. Adult African-American, non-Latina White, and Latina women will be recruited.
      Women will initially be randomized to 4 groups: 1. no message control; 2. 1-sided message
      that mentions benefits of HIV testing; 3. 2-sided message that acknowledges minor opposition
      to testing, then refutes the opposition; and 4. 2-sided message that acknowledge stronger
      opposition to testing, then refutes the opposition. Women will be offered HIV testing, then
      re-randomized to a similar set of 4 messages related to HIV vaccine trials. There will
      therefore be 16 groups in total (4 X 4).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  18 years of age or older

          -  Able to understand English or Spanish

          -  Able to give informed consent

        Exclusion Criteria:

          -  Not female

          -  Under 18 years of age

          -  Not able to understand English and Spanish

          -  Unable to give informed consent
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis
Intervention: SOF/VEL; SOF/VEL/VOX
Intervention description: 400/100 mg FDC tablet orally once daily.; 400/100/100 mg FDC tablet orally once daily.
Intervention MeSH terms: Sofosbuvir; Velpatasvir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 87.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC)
      and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV
      infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Chronic HCV infected males and non-pregnant/non-lactating females

          -  Treatment-naive or treatment-experienced individuals

          -  Non-cirrhosis or compensated cirrhosis at screening

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
DHA Supplementation and Pregnancy Outcome
Condition: Pregnancy
Intervention: DHA; Placebo capsule
Intervention description: 600 mg DHA; Placebo capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 350.0
Sex: Female
Minimum age: 16 Years
Maximum age: 36 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to determine if increasing DHA intake during pregnancy can
      increase gestation duration and enhance infant and childhood outcomes related to visual
      acuity, stereoacuity, attention, and distractibility.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant 8-20 wks at enrollment

          -  single fetus

          -  BMI <40

        Exclusion Criteria:

          -  diabetes (Type I, ii, GDM)

          -  hypertension (primary, PIH, preeclampsia/eclampsia)
Telaprevir Plus Standard of Care (SOC) in HCV Associated Hepatocellular Carcinoma (HCC)
Condition: Infection
MeSH terms: Infections; Communicable Diseases; Carcinoma; Carcinoma, Hepatocellular
Intervention: Pegylated Interferon Alfa 2a; Ribavirin; Telaprevir
Intervention description: Starting dose: 180 mcg subcutaneously once weekly.; Starting dose: 1,000 mg by mouth daily.; Starting dose: 750 mg by mouth 3 times a day.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Infection; Hepatitis C Genotype 1 Infection; Hepatitis C virus; HCV; Hepatocellular Carcinoma; HCC; Liver Transplantation; Pegylated Interferon Alfa 2a; PegIFN alfa-2a; Ribavirin; RBV; Telaprevir; Incivek; Antiviral drugs

Summary:

      The goal of this clinical research study is to learn if the antiviral combination of
      telaprevir, pegylated Interferon Alfa 2a (PegIFN alfa-2a) and ribavirin (RBV) can prevent the
      virus from coming back after the liver transplant.

      Telaprevir, PegIFN alfa-2a, and RBV are different antiviral drugs that work in combination at
      different stages of the HCV infection to stop the virus.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females aged ≥ 18 and ≤ 70 years

          2. Detectable Hepatitis C Virus ribonucleic acid (HCV-RNA) in serum

          3. HCV genotype 1 infection

          4. Child-Pugh-Turcotte (CPT) score < 7 and Model for End-Stage Liver Disease (MELD) score
             < 18

          5. PegIFN alfa-2a/RBV-naïve or previously treated patients (partial responders, null
             responders and relapsers)

          6. Hepatocellular carcinoma within transplant criteria in the United Network for Organ
             Sharing (UNOS) Region IV:

               1. Single lesion up to 6 cm, or

               2. Two or three lesions with largest no greater than 5 cm and the total tumor
                  diameter no greater than 9 cm

          7. Listed for liver transplantation

          8. Willingness to give written consent and agree to double contraception

        Exclusion Criteria:

          1. Decompensated cirrhosis

          2. Baseline platelet count less than 35,000/µL

          3. Baseline hemoglobin level less than 10 g/dL

          4. Baseline absolute neutrophil count less than 750/mm3

          5. Baseline creatinine clearance < 50 mL per min.

          6. Women with a positive pregnancy test at baseline or men whose female partners are
             pregnant or are contemplating pregnancy

          7. Intolerance or contraindications to PegIFN alfa-2a/RBV use per standard treatment
             guidelines
The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction
Condition: Coronary Disease; Ventricular Dysfunction, Left
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ventricular Dysfunction; Ventricular Dysfunction, Left
Intervention: Ivabradine; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 10917.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The aim of this study is to test whether ivabradine is able to reduce cardiovascular events
      when given to patients with coronary artery disease and impaired heart function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Coronary artery disease

          -  Left ventricular systolic dysfunction

          -  Sinus rhythm: heart rate (HR) >= 60 beats per minute (bpm)

        Exclusion Criteria:

          -  Unstable cardiovascular condition

          -  Severe congestive heart failure
A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone ER
Intervention description: Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 188.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Paliperidone ER; Treatment naive patients; Newly diagnosed patients

Summary:

      The purpose of this study is to explore the tolerability, safety and efficacy of flexibly
      dosed paliperidone extended release (ER) among patients with schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with schizophrenia

          -  Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at
             screening

          -  Patients who have not taken any antipsychotics in the past, and those were newly
             diagnosed with schizophrenia who have not taken any antipsychotics for at least one
             month prior to screening

          -  Patient healthy on the basis of a physical examination, laboratory examination, and
             vital signs

          -  Women must have a negative pregnancy test, and agree to practice an effective method
             of birth control before entry and throughout the study

        Exclusion Criteria:

          -  Serious unstable medical condition, including known clinically relevant laboratory
             abnormalities

          -  Judged to be at high risk for adverse events, violence or self-harm

          -  Inability to swallow the study medication whole with the aid of water (patients may
             not chew, divide, dissolve, or crush the study medication)

          -  Biochemistry results that are out of the laboratory's normal reference range and are
             deemed to be clinically significant by the investigator

          -  Patients with a current use or known history (over the past 6 months) of substance
             dependence

          -  Positive urine drug examination
A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Double-blind adalimumab; Double-blind Placebo; Open-label Adalimumab; Open-labelAdalimumabRescue
Intervention description: Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow); Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow); Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study; Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 334.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis

Summary:

      To evaluate the potential of adalimumab to inhibit radiographic progression in joint
      destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid
      arthritis.
    

Eligibility criteria:

        Inclusion Criteria

          -  Rheumatoid arthritis based on the American College of Rheumatology criteria

          -  Methotrexate or leflunomide naïve

          -  Disease duration less than or equal to 2 years from diagnosis

        Exclusion Criteria

          -  History of acute inflammatory joint disease of different origin from rheumatoid
             arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV

          -  Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20
             antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus

          -  Joint surgery involving joints to be assessed within 8 weeks prior to Screening
Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT).
Condition: Menopause
Intervention: LNG IUS
Intervention description: LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 394.0
Sex: Female
Minimum age: 46 Years
Maximum age: 51 Years
Healthy volunteers: No

Summary:

      The study has been designed to look at the transfer from using LNG IUS for contraception
      only, in reproductive age to using it for endometrial protection in menopausal age. The main
      area of interest in the study is the pattern of any vaginal bleeding that occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with intact uterus, regular menstrual cycles and no previous or current
             climacteric symptoms.

        Exclusion Criteria:

          -  Pregnancy or lactation.

          -  Previous pelvic infections.

          -  Abnormal bleeding.

          -  Abnormal uterine cavity.

          -  Uterine polyps.

          -  Genital cancer.

          -  Liver diseases.

          -  Alcoholism or drug abuse.
An Efficacy and Safety Study of Galantamine for the Treatment of Patients With Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Placebo; Galantamine 16 mg/day; Galantamine 24 mg/day
Intervention description: Form= tablet, route= oral use. Corresponding placebo tablets confirmed to be indistinguishable from the galantamine tablets will be administered for 24 weeks.; Type= exact number, number= 8, 16, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, and 16 mg galantamine daily for the remaining 20 weeks.; Type= exact number, number= 8, 16, 24, unit= mg/day, form= tablet, route= oral use. Patients will receive 8 mg galantamine daily for the first 4 weeks, then 16 mg galantamine daily for the following 4 weeks, and 24 mg galantamine daily for the remaining 16 weeks.
Intervention MeSH terms: Galantamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 580.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Cognitive dysfunction; Dementia; Galantamine; R113675

Summary:

      The purpose of this study is to evaluate the efficacy and safety of two fixed doses (16mg/day
      and 24mg/day) of galantamine (a drug for treating dementia) versus placebo for the treatment
      of patients with Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients with a diagnosis of Alzheimer's disease according to the National
             Institute of Neurological and Communicative Disorders and the Alzheimer's Disease and
             Related Disorders Association (NINCDS-ADRDA) criteria

          -  Having a Mini-Mental Status Examination (MMSE) score of 10 - 22 inclusive

          -  Having an Alzheimer's Disease Assessment Scale - Japan cognitive subscale (ADAS-J cog)
             score of at least 18

          -  Exhibiting an onset and progression of cognitive dysfunction during at least 6 months
             prior to the screening period

        Exclusion Criteria:

          -  Patients with neurodegenerative diseases other than Alzheimer's disease, such as Lewy
             bodies disease, (dementia due to tiny round structures made of proteins that develop
             within nerve cells in the brain), Parkinsonism, etc

          -  Patients with cognitive dysfunction due to cerebral damage resulting from a lack of
             oxygen, a brain injury, etc

          -  Patients with multi-infarct dementia (brought on by a series of strokes) or active
             cerebrovascular disease

          -  Patients with clinically significant cardiovascular disease

          -  Patients currently taking drugs such as a cholinesterase inhibitors, which improve
             cerebral circulation/metabolism
Abuse Liability of Suboxone Versus Subutex
Condition: Opioid-related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: Heroin; Naloxone; Low Bup Dose; High Bup Dose; Low Bup/Nal Dose; High Bup/Nal Dose; Placebo (PCB)
Intervention description: Heroin (25 mg); .4 mg; 4 and 8 mg; 8mg and 16 mg; Buprenorphine/Naloxone 4/1 mg, 8/2 mg; Buprenorphine/Naloxone 8/2 mg, 16/4 mg; Placebo control administration
Intervention MeSH terms: Buprenorphine, Naloxone Drug Combination; Buprenorphine; Heroin; Naloxone
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 19.0
Sex: All
Minimum age: 21 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study is designed to compare the abuse liabilities of intravenous buprenorphine and
      buprenorphine/naloxone in individuals who are physically dependent on sublingual
      buprenorphine. We hypothesize that the abuse liability of buprenorphine/naloxone is lower
      than that of buprenorphine alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnostic and Statistical Manual (DSM) IV criteria for heroin dependence

          -  No major mood, psychotic, or anxiety disorder

          -  Physically healthy

          -  Able to perform study procedures

          -  21-45 years of age

          -  Normal body weight

          -  Current use of i.v. opioids in amounts and/or frequencies that meet or exceed those
             used in the proposed study (1-2 bags of heroin per occasion at least twice per day)

          -  Self-administer at least 4 mg i.v. buprenorphine above placebo levels during the dose
             run up phase

        Exclusion Criteria:

          -  DSM IV criteria for dependence on drugs other than opioids, nicotine or caffeine

          -  Participants requesting treatment

          -  Participants on parole or probation

          -  Pregnancy or lactation

          -  Birth, miscarriage or abortion within 6 months

          -  Current or recent history of significant violent behavior

          -  Current major Axis I psychopathology, other than opioid dependence (e.g., mood
             disorder with functional impairment or suicide risk, schizophrenia), that might
             interfere with ability to participate in the study

          -  aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper
             limit of normal

          -  Significant suicide risk

          -  Current chronic pain

          -  Sensitivity, allergy, or contraindication to opioids

          -  Current or recent (past 30 days) physical dependence on or treatment with methadone,
             buprenorphine, or the buprenorphine/naloxone combination
Long-Term Safety Study of MT-2412 in Japanese Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Teneligliptin/Canagliflozin
Intervention description: Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.
Intervention MeSH terms: Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: MT-2412; MP-513; TA-7284; Teneligliptin; Canagliflozin

Summary:

      The purpose of this study is to evaluate the safety and efficacy of co-administration of
      Teneligliptin (MP-513) and Canagliflozin (TA-7284) once daily for 52 weeks in Japanese
      patients with Type 2 diabetes mellitus who are receiving treatment with Teneligliptin and
      have inadequate glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women age ≥20 years old

          -  HbA1c of ≥7.0% and <10.5%

          -  FPG of ≤ 270 mg/dL

          -  Patients who are under dietary management and taking therapeutic exercise for diabetes
             over 12 weeks before treatment period

        Exclusion Criteria:

          -  Patients with type I diabetes, diabetes mellitus resulting from pancreatic disorder,
             or secondary diabetes

          -  Patients with serious diabetic complications

          -  Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria

          -  Patients with Class III/IV heart failure symptoms according to New York Heart
             Association (NYHA) functional classification

          -  Patients with severe hepatic disorder or severe renal disorder.