bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores
      what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a
      and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never
      received treatment for their hepatitis C infection.
    

Detailed description: 
      This is a Phase 2, randomized (The study medication is assigned by chance.), 5-arm, open
      label (All people know the identity of the intervention.), multicentre (study conducted at
      multiple sites) study. Approximately, 84 participants will be randomized to 5 different arms
      in a 2:2:1:1:1 ratio. In treatment arms 1 and 2, participants will receive 12 weeks of triple
      therapy (use of 3 medications) with TMC435 50 or 100 mg once daily plus Peginterferon Alfa-2a
      and Ribavirin followed by 12 weeks of treatment with Peginterferon Alfa-2a and Ribavirin. In
      treatment arms 3 and 4, participants will receive 24 weeks of triple therapy with TMC435 50
      or 100 mg once daily plus Peginterferon Alfa-2a and Ribavirin. In treatment arm 5 (control
      group), participants will receive Peginterferon Alfa-2a and Ribavirin for 48 weeks. This
      study will consist a screening phase of upto 6 weeks, treatment phase of upto 48 weeks and a
      post treatment follow-up period of 24 weeks. Safety evaluations will include assessment of
      adverse events, clinical laboratory tests, vital signs, and cardiovascular safety.
    

Intervention name(s): TMC435; PegIFNα-2a; RBV
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One 50 or 100-mg capsule orally (by mouth), once daily for 12 or 24 weeks; One subcutaneous injection of PegIFNα-2a 180 μg once weekly for 12, 24, or 48 weeks.; 300, 400, or 500-mg tablets orally twice daily for 12, 24, or 48 weeks.
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; Hepatitis C virus; Interferon Alfa-2a; Ribavirin; Viral RNA
Asian Women's Action in Resilience and Empowerment
Condition: Mental Health Disorder
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      Our objective for this R34 is to develop gender/culture specific and trauma informed group
      psychotherapy intervention designed to treat Chinese-, Korean-, and Vietnamese-American young
      women with histories of interpersonal violence trauma. The intervention is called Asian
      Women's Action for Resilience and Empowerment (AWARE).
    

Detailed description: 
      Recent epidemiological studies document two emerging public health problems among
      Asian-Pacific Islander (API) women in the US:

        1. A growing incidence of HIV/AIDS. Although the prevalence of HIV/AIDS among APIs is low
           compared to those among Blacks, Whites, and Hispanics, HIV infection among APIs
           significantly increased (44%) between 2004 and 2007. Additionally, 75% of HIV
           transmission among API women is through heterosexual intercourse, which is substantially
           higher than percentages among other racial/ethnic groups of women.

        2. Poor mental health functioning exhibited by completed suicide rates. Young API women
           (ages 15 to 34) have not only the highest rates of completed suicide compared to other
           women of the same age in the US, but also experienced the largest growth in rates of
           suicide over the past decade.

      Our preliminary studies using both quantitative and qualitative methods found strong links
      between past trauma and poor sexual and mental health outcomes. For API women, reporting a
      history of forced sex was associated with higher odds of severe depression, substance use,
      getting pregnant, and HIV risk behaviors compared to API women who did not report a history
      of forced sex. API women continue to be vulnerable given their lower rates of HIV testing,
      lower mental health utilization, and premature dropout rates in mental health treatment
      compared to other racial groups. So far, no existing intervention targets both sexual health
      and mental health problems among API women. Specifically, this study builds upon data on API
      women from prior NIMH-funded work as the foundation for our intervention.
    

Intervention name(s): AWARE intervention
Intervention type(s): Behavioral
Intervention description(s): Group psychotherapy for Asian-American women
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: We employed a two-arm randomized clinical trial to test the preliminary feasibility, safety, and efficacy for AWARE intervention comparing the AWARE intervention group (n=48) with the wait-list group (n =48).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mental health; Suicide; Sexual risk behaviors
Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Observational

Summary: 
      This is a comparative, open label, parallel group, non interventional study to further
      demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops.
      In addition the effectiveness and safety shall be compared to Azelastine containing nasal
      Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes
      Azelastine nasals spray and eye drops according to the instructions for use. The observation
      takes place over a period of 7 days. Response to treatment is recorded at day 7 by the
      physician and in daily by the patient in a dairy.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary Care Clinic
      
Keywords: ectoine; allergic rhinitis; bitop
Early Oral Intake Following Cesarean Surgery
Condition: Obstetrics; Surgery
Study type: Interventional

Summary: 
      In this study we are trying to compare the safety and financial benefit of starting the
      realimentation early versus conventional oral intake following the Cesarean surgery in Iran.
    

Detailed description: 
      Cesarean delivery is announced to constitute 50% of deliveries in the Capital and 39% of all
      the deliveries nationwide, which is far beyond the acceptable international normal range,
      according to the official site of the Ministry of Health and Medical Education of the Islamic
      Republic of Iran [http://www.mohme.gov.ir/HNDC/Indicators/Simaye_Salamt/Simaye_Salamat.htm].
      This high rate of elective cesarean deliveries might be due to several reasons which are far
      beyond the scope of this study. Here we tried to see whether the reduction in the time of
      hospitalization for these patients is safe at the expense of earlier oral realimentation and
      to see whether this strategy increases the patients' satisfaction or not.
    

Intervention name(s): Oral Intake following admittance to the postpartum ward
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Supportive Care
Keywords: Cesarean; Oral; Intake
Fat Distribution in Healthy Early Postmenopausal Women
Condition: Healthy; Postmenopause
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to explore the effects of hormone replacement therapy with EV/DNG on
      abdominal fat distribution measured by magnetic resonance imaging.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor
      of the trial.
    

Intervention name(s): Climodien / Lafamme (BAY86-5027); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet daily (2 mg EV + 2 mg DNG); 1 tablet daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early postmenopausal state; Climacteric symptoms; Hormone replacement therapy
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986120 in Healthy Subjects and the Effects of Co-Administration of Midazolam and BMS-986120
Condition: Healthy Adult Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability and effect on Midazolam
      pharmacokinetics of multiple oral doses of BMS-986120 in healthy subjects.
    


Intervention name(s): BMS-986120; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Midazolam; BMS-986120
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Centralized Reading Assessment of Chronic CerebroSpinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis and Other Neurological Diseases
Condition: Clinically Isolated Syndrome (CIS); Multiple Sclerosis (MS); Other Neurological Disorders (OND); Healthy (HC)
MeSH terms: Multiple Sclerosis; Nervous System Diseases; Venous Insufficiency; Sclerosis
Study type: Observational

Summary: 
      This a retrospective, blinded trial in which collaborators in Italy will review the doppler
      findings from the Combined Transcranial and Extracranial Venous Doppler (CTEVD) trial in an
      attempt to measure reproducibility.
    

Detailed description: 
      This study will retrospectively investigate doppler images from the second phase of the CTEVD
      trial.

        1. To determine the prevalence of CCSVI in patients with MS, compared with the prevalence
           observed in a control population consisting of Other Neurological Diseases (OND)
           patients and Healthy Controls (HC) by using blinded, controlled centralized ultrasound
           reading assessment of 5 Venous Haemodynamic (VH) CCSVI CCSVI Doppler UltraSound (CDUS)
           criteria.

        2. To investigate whether prevalence of CCSVI is different between centralized and local
           CDUS reading of 5 VH CCSVI CDUS criteria.

        3. To investigate the prevalence of CCSVI in patients with MS, compared with the prevalence
           observed in a control population consisting of OND patients and HC, when bidirectional
           flow in the intracranial veins and sinuses CDUS criterion is not considered as part of
           VH CCSVI CDUS criteria.

        4. To determine whether prevalence of CCSVI in patients with MS, compared with the
           prevalence observed in a control population consisting of OND patients and HC differs
           when using CDUS velocity and flow parameters in the Internal Jugular Veins (IJVs) and
           Vertebral Veins (VVs).

        5. To determine the reproducibility of VH criteria by using of centralized and local
           blinded, controlled CDUS reading assessment.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in this study will be those who had participated in the second phase of the
        Combined Transcranial/Extracranial Venous Deficiency (CTEVD) study.
A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-dose, randomized, double-blind, double-dummy, placebo-controlled,
      positive-controlled four-way crossover study will evaluate the effect of a single dose of
      danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects
      will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of
      danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D:
      placebo, with a washout period of at least 7 days between treatments.
    


Intervention name(s): danoprevir; danoprevir; danoprevir placebo; moxifloxacin; moxifloxacin placebo; ritonavir; ritonavir placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 100 mg single dose orally; 400 mg single dose orally; single oral dose; 400 mg single dose orally; single oral dose; 100 mg single dose orally; single oral dose
Intervention MeSH terms: Ritonavir; Moxifloxacin; Lactams; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Bioequivalence Study of Mofest® 400mg (Moxifloxacin) Tablet With Avelox® 400mg (Moxifloxacin) Tablet in Healthy Pakistani Subjects
Condition: Healthy Individuals; Bioequivalence Study
Study type: Interventional
Phase: Phase 1

Summary: 
      Single oral dose, of test and reference Tablet will be administered to healthy volunteers,
      after at least 10 hours fast together with 240 mL of ambient temperature water at their
      scheduled dosing time-points. Blood samples will be taken up to 72.0 hours post-dose.
    


Intervention name(s): Moxifloxacin 400mg
Intervention type(s): Drug
Intervention description(s): Moxifloxacin 400mg IR tablet
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A single center, open label, randomized, single-dose, two-period, two-way cross-over study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fluoroquinolone; Moxifloxacin; Bioequivalence; Pakistani Population
Family Dietary Coaching to Improve Nutritional Intakes and Body Weight Control
Condition: Primary Prevention; Obesity Prevention; Body Weight Control
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      We hypothesize that Family Dietary Coaching for one school year will allow a nutritional
      shift towards following recommendations and improve health indicators in free-living children
      and adults.
    

Detailed description: 
      Insufficient evidence supports the feasibility and the efficacy of current nutritional
      recommendations to prevent obesity. The purpose of this study is to test the hypothesis that
      family dietary coaching would improve nutritional intakes and health indicators in
      free-living children and adults.

      Intervention: the 1013 participating families (1013 children and 1013 parents) are randomly
      assigned to Group A (advice to reduce fat and to increase complex carbohydrates), Group B
      (advice to reduce both fat and sugars and to increase complex carbohydrates) or a control
      group (no advice). GA and GB receive monthly phone counseling and Internet-based monitoring.
      Main outcome measures are changes in nutritional intakes and body mass index throughout the
      intervention in both children and adults. Secondary outcomes included changes in fat mass,
      physical activity, fasting blood indicators and food-related quality of life.
    

Intervention name(s): Fat and carbohydrate controlled diet
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Keywords: obesity; prevention; children; adults; family; dietary; coaching; body mass index; fat mass
Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes
Condition: Overweight; Obesity
MeSH terms: Overweight; Body Weight
Study type: Interventional

Summary: 
      This study will asses the decrease in body weight after repeated administration of Gelesis100
      in overweight and obese subjects with and without Type 2 Diabetes.
    

Detailed description: 
      To asses the decrease in body weight after repeated administration of Gelesis100 in
      overweight and obese subjects with and without Type 2 Diabetes.
    

Intervention name(s): Gelesis100; placebo
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Rituxmab Versus IL-6 in Treating ILD
Condition: Interstitial Lung Disease; Scleroderma
MeSH terms: Lung Diseases; Lung Diseases, Interstitial; Scleroderma, Systemic; Scleroderma, Diffuse
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      All SSc patients should know if they have been diagnosed with interstitial lung disease, or
      pulmonary hypertension and keep results from his/her last pulmonary function test, chest
      imaging, echocardiogram and stress test
    

Detailed description: 
      All SSc patients should know if they have been diagnosed with interstitial lung disease, or
      pulmonary hypertension and keep results from his/her last pulmonary function test, chest
      imaging, echocardiogram and stress test Diffuse infiltrative lung disease (ILD): progressive
      shortness of breath is the most frequently presentation going to ER pulmonary unit first. It
      should be considered in case of persistent dry cough or dyspnea, which should be looked for
      in any patient with SSc. an etiological assessment must be conducted in order not to
      mistakenly attribute ILD to the SSc.
    

Intervention name(s): Rituximab; IL6 inhibitor
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion 1000 mg; 6 mg/kg I V infusion monthly
Other intervention name(s): Rituxan; Actemra
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Hyperinsulinism
MeSH terms: Polycystic Ovary Syndrome; Hyperinsulinism; Syndrome
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Determine whether reduction of serum insulin levels by metformin increases ovulatory
      response to clomiphene citrate in women with polycystic ovary syndrome.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study.
      Patients are randomized to one of two treatment arms.

      Patients receive oral metformin or oral placebo three times daily for 7 weeks. Patients
      remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral
      clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110. Following
      ovulation, treatment with clomiphene citrate and metformin or placebo continues until 6
      ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients receiving the
      placebo arm who have not ovulated on the highest dose of clomiphene citrate may be crossed
      over to receive metformin after a 6 week washout.
    

Intervention name(s): clomiphene citrate; metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Clomiphene; Enclomiphene; Zuclomiphene
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: endocrine disorders; hyperinsulinism; polycystic ovarian syndrome; rare disease
Guided Antiplatelet Therapy in Interventional Treatment of Intracranial Aneurysms
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      The use of intracranial stents expands the possibilities for endovascular treatment of
      intracranial aneurysms and improves the success rate. However, it also increases the risk of
      ischemic complications in patients. The current standard dual antiplatelet regimen is
      considered crucial in reducing thrombotic events. Nevertheless, some patients exhibit
      resistance to antiplatelet drugs, which puts them at a higher risk of thrombotic events. In
      clinical practice, there is a lack of standardized platelet function testing and consensus on
      adjusting antiplatelet drug programs. This study conducted a multi-center, prospective
      cluster randomized controlled trial to investigate whether antiplatelet adjustment therapy
      guided by light transmittance aggregometry (LTA) detection can decrease the occurrence of
      ischemic events after stent implantation in patients with unruptured intracranial aneurysms.
      Additionally, the study aimed to establish a set of standardized antiplatelet regimens.
    


Intervention name(s): Adjustment of Antiplatelet Drugs
Intervention type(s): Drug
Intervention description(s): The maximum platelet aggregation rate induced by arachidonic acid (AA-MPA)≥20%, give aspirin 200mg qd. The maximum platelet aggregation rate induced by adenosine diphosphatase (ADP-MPA)≥36.4% for flow diversion, give ticagrelor 60mg bid. ADP-MPA≥42.9% for stent-assisted coil embolization，give ticagrelor 60mg bid. ADP-MPA<20%, give clopidogrel 37.5mg qd. The timing of drug adjustment should be at least 1 day before stent implantation, and the LTA testing should be performed again 48 hours after the drug adjustment. For patients whose ADP-MPA does not reach the normal range, a second antiplatelet drug adjustment should be performed: ticagrelor overdose: reduce to 45mg bid; ticagrelor resistance, increase to 90 mg bid.
Intervention MeSH terms: Platelet Aggregation Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: cluster randomized controlled cohort study
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Intracranial Aneurysm; Interventional Therapy; Stent; Platelet; Ischemic Stroke; Bleeding Event
A Study to Assess the Effects of Itraconazole and Etravirine on JNJ-64417184 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effects of itraconazole or etravirine on
      the single-dose pharmacokinetics (PK) of JNJ 64417184 in healthy adult participants.
    


Intervention name(s): JNJ-64417184; Itraconazole; Etravirine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JNJ 64417184 tablets will be administered orally.; Itraconazole capsules will be administered orally; etravirine tables will be administered orally.
Intervention MeSH terms: Itraconazole; Etravirine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment