bioihbjkbjnl/mcl2 huggingface dataset:
Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection
Condition: Hepatitis C, Chronic
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with chronic hepatitis C genotype 1 virus infection are usually treated with
      Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for
      others too short. An individually adapted therapy length from 24 to 72 weeks will be
      determined in dependence of the initial virus load and the time to HCV RNA negativity.

      The primary objective is to compare the cumulative rate of the sustained viral response (SVR)
      of the patients with the individually adapted therapy duration to the SVR rates of a historic
      patient collective under the 48 week standard therapy.
    

Detailed description: 
      Further objectives of this trial are:

      To record the tolerance of the therapy with Peginterferon alfa-2b plus Ribavirin over 72
      weeks inclusive the adverse reactions and the withdrawal rates.

      To evaluate the biochemical response to the treatment (ALT values during and after the
      therapy) in comparison to the virological response to the treatment.

      To evaluate the validity of the withdrawal rules of this trial at week 12 and 24 in
      comparison to the 2-log-rule and a qualitative detection of the HCV RNA at week 24 with a
      detection limit of 50 IU/ml.

      To evaluate the impact of the HCV RNA concentration before the therapy, and the HCV kinetic
      during the therapy on the response to the treatment in the different groups.

      To evaluate the impact of the serum concentration of Ribavirin on anaemia and the virological
      therapy response, as well as the dependence of the serum concentration of Ribavirin on the
      creatinine clearance in comparison to the body weight.
    

Intervention name(s): Ribavirin; Peginterferon alfa 2b
Intervention type(s): Drug; Drug
Intervention description(s): Rebetol 200 mg: applied as hard capsule; PegIntron (50/80/100/120/150 microgram): applied by injection
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic HCV infection; Genotype 1; Individually adapted therapy; Peginterferon alfa-2b; Ribavirin; Sustained viral response (SVR)
Differences in Music Perception Skills Between Child, Teen and Adult Cochlear Implant Recipients
Condition: Cochlear Implant Recipients
Study type: Observational

Summary: 
      Adult recipients of cochlear implants (CI) generally loose interest in listening to music.
      This may be due to the rather limited spectral resolution of CI. However, child
      CI-recipients, if offered the opportunity, like to listen to music. They participate actively
      in musical acitivities, such as singing, dancing or playing an instrument. Thus, there seems
      to be a fundamental difference in the music perception of people who receive CI as child or
      as adult.

      This study assesses music perception skills of child, teen and adult cochlear implant
      recipients in settings with simple tone sequences and in a more complex, melodious context.
    


Intervention name(s): Assessment of music perception skills
Intervention type(s): Behavioral
Intervention description(s): A sequence of tones is presented to participants. Then the same sequence is presented again, with the 4th tone being one to six half tones different from the first sequence. Participants are asked to indicate when they hear a difference betweent the first and the second sequence.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy CI recipients that receive their regular follow-ups in the ENT-clinic of the Zurich
        University Hospital.
A Study to Determine the Effect of Multiple Oral Doses of SLx-2119 in Healthy Male Subjects
Condition: Immune System Disorder (Healthy Volunteer)
MeSH terms: Immune System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of
      multiple doses of SLx-2119 in healthy male participants.
    

Detailed description: 
      Duration per participants is Day 1 up to 30 days after participant is treated with the last
      dose of study drug.
    

Intervention name(s): Belumosudil mesylate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: capsule; Route of administration: oral; Pharmaceutical form: capsule; Route of administration: oral
Other intervention name(s): SLx-2119; KD025; SAR445761
Intervention MeSH terms: Belumosudil
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The BCD-089 (aIL6R) in Patients With Active Rheumatoid Arthritis
Condition: Seropositive RA
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is Phase II randomized, double-blind, placebo-controlled clinical trial to evaluate
      efficacy and safety, pharmacokinetics and pharmacodynamics of 2 dosing regimens (qw and q2w,
      s/c) of monoclonal antibody to IL6R (BCD-089) in patients with active rheumatoid arthritis
      and inadequate response to methotrexate.
    

Detailed description: 
      IL-6 is a new potential therapeutic target which plays important role in pathogenesis of
      several autoimmune disorders including rheumatoid arthritis. BCD-089 is a novel fully human
      monoclonal antibody against the interleukin-6 receptor developed by JCS BIOCAD (Russia) which
      is successfully passed phase I clinical study. Fixed dose of 162 mg was chosen for evaluation
      in phase II clinical trial. Comparisons in terms of efficacy, safety, PK/PD will be made for
      every week and every other week dosing for 54 weeks. W0-W12, planed as blinded, "main" period
      of the study, consists of three arms (n=35, each) - 2 study arms and placebo arm and served
      to test the hypothesis of superiority of BCD-089 to placebo. W12-W54, planned as "open"
      period of the study and served to evaluate long-therm safety and efficacy of BCD-089 in
      patients with active rheumatoid arthritis.
    

Intervention name(s): BCD-089, 162 mg, s/c, qw; BCD-089, 162 mg, s/c, q2w; placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Subcutaneous injections of anti-IL6R every week; Subcutaneous injections of anti-IL6R every other week; Subcutaneous injections of placebo every week, until week 12. Thereafter subcutaneous injections of anti-IL6R every other week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Physical Activity During Social Isolation
Condition: Social Isolation
Study type: Observational

Summary: 
      The aim of the study is to evaluate the physical activity level and the factors affecting
      physical activity among young adults who are socially isolated due to coronavirus.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Young Adults from Community Sample
      
Keywords: physical activity; young adult; coronavirus
Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)
Condition: Malaria, Falciparum; Anemia
MeSH terms: Malaria, Falciparum
Study type: Interventional

Summary: 
      A cluster-randomized control trial will study the effect of insecticide-treated wall lining
      on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study
      will receive insecticide-treated wall lining covering their walls and ceilings in addition to
      long-lasting insecticidal nets, while the other half will be protected by existing
      long-lasting insecticidal nets.
    

Detailed description: 
      Long-lasting insecticidal nets (LLINs) are the established vector control product for malaria
      control. In Bomi County Liberia, LLINs have been distributed but malaria prevalence in
      children under 5 remains high, with prevalence in study villages found to be 42% in April
      2014. The major malaria vector species are resistant to pyrethroid insecticides approved for
      use in LLINs, and new control measures with non-pyrethroid active ingredients may protect the
      population.
    

Intervention name(s): Insecticide treated wall lining
Intervention type(s): Device
Intervention description(s): Polypropylene non-woven fabric.
Other intervention name(s): Durable wall lining; PermaNet Lining
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluate the Pharmacokinetics of Warfarin When Coadministered With PEX168 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the effect of PEX168 doses on the pharmacokinetics of warfarin in healthy
      subjects.To provide a scientific basis for clinical drug combination of PEX168.

      To evaluated the impact of pharmacodynamics coadministrated hypodermic PEX168 and warfarin in
      healthy subjects.

      To assess the safety of single doses of warfarin administered with and without PEX168
    

Detailed description: 
      This was an open-label, sequential, single-center study that evaluated the pharmacokinetics
      of warfarin when coadministered with PEX168 in healthy adult subjects. The total duration of
      each subject's participation in the study was approximately 13 weeks, which included up to a
      14-day Screening Period, a 51-day Treatment Period, and an approximately 4-week Follow-up
      Period.

      Center: This study was conducted at a single site in the first affiliate hospital of Zhejiang
      University.All subjects receives a single 5mg oral dose of warfarin on Day 1 followed by 5
      weekly 200μg doses of PEX168 injected subcutaneously beginning on Day 8 and a second single
      5mg oral dose of warfarin on Day 44.
    

Intervention name(s): PEX168; Warfarin
Intervention type(s): Drug; Drug
Intervention description(s): 200µg,injected subcutaneously,once a week.; 5mg,oral,two times.
Other intervention name(s): Polyethylene Glycol Loxenatide; Warfarin sodium tablets
Intervention MeSH terms: Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Type 2 diabetes mellitus
Effect of Laser Acupuncture Augmented by Abdominal Exercises on Abdominal Fat
Condition: Obesity, Abdominal
MeSH terms: Obesity, Abdominal
Study type: Interventional

Summary: 
      the aim of study is to investigate the effect of laser acupuncture and abdominal exercises on
      abdominal fat in breast feeding women
    

Detailed description: 
      Forty breast feeding women aged between 20 and 35 years will recruited to the study in the
      women health department faculty of physical therapy clinic, kafr el sheikh university ,
      Egypt. The evaluation procedures will explained to each participant. participants will be
      divided into two groups Group A : received laser acupuncture, diet modification and abdominal
      exercises Group B: received diet modification and abdominal exercises only

      Out come measurement BW, BMI, body fat mass (BFM), body fat percent, waist girth, hip girth,
      and waist-to-hip ratio (WHR) were measured at baseline and the end of treatment. BW, BMI,
      BFM, and body fat percent were measured using the body composition analyzer (Model Inbody
      3.0, Republic of Korea).
    

Intervention name(s): laser acupuncture and abdominal exercises
Intervention type(s): Other
Intervention description(s): laser acupuncture on certain point on the abdomen The following abdominal acupuncture points were irradiated: Cv 8 (Shenque), St 25 (Tianshu, bilateral), and Sp 15 (Daheng
, bilateral). The laser irradiations were applied directly to the skin of the points with a perpendicular beam. 478 J/cm2
Abdominal exercises:
Types of abdominal exercises:
Static abdominal exercises:
Dynamic abdominal exercises:
Hip shrugging exercise from crook lying position:
Lateral flexion of the trunk from crook lying position:
Antero-posterior flexion of the trunk from crook lying position:
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: obesity; laser acupuncture; abdominal exercises
Dietary Nitrate Supplementation and Crossfit Athletes
Condition: Performance
Study type: Interventional

Summary: 
      In the past, dietary nitrate supplementation has been shown to have clinical benefits in the
      treatment of cardiovascular issues. More recently, however, the focus of nitrate
      supplementation has shifted to focus of human performance, and has shown to increase the time
      to exhaustion during maximal intensity exercise and lower the cost of oxygen consumption
      during submaximal intensity exercise. Acutely, nitrate supplementation in the form of
      beetroot juice has been shown to increase strength measurements, as well as increase the time
      to complete a 2000 meter rowing ergometer test. However, to the author's knowledge, there are
      no studies that link the relationship between multi-day nitrate supplementation and the
      rowing test or the nitrate's effect on strength when in the salt form. Additionally, to the
      author's knowledge, no evidence has been published which relates dietary nitrate
      supplementation and its effects on a CrossFit circuit workout.

      Our central hypothesis is that six days of dietary nitrate supplementation will improve
      strength, endurance, a power more than a placebo in male CrossFit athletes.
    

Detailed description: 
      The purpose of this randomized, double-blind, crossover study is to identify if dietary
      nitrate supplementation improves strength , endurance, and power measurements in male
      CrossFit athletes. Specifically, the strength measurements will be taken using isometric and
      isokinetic tests on the Biodex dynamometer. Endurance will be measured using time trials for
      a 2000 meter rowing test and the "Fran" CrossFit workout. Finally, power will be analyzed
      using the Wingate cycle test.

      The treatment group will receive 1 serving of f potassium nitrate KNO3- (N) (8 mmols NO3-).
      The placebo group will receive 1 serving of the nitrate-free placebo (PL) potassium chloride
      (8 mmol KCl).

      The participants will complete two three-day baseline testing, with a six-day supplementation
      period following each round of baseline testing. Following the first six-day supplementation
      period, there will be a 10 day washout period before the second baseline testing begins.
    

Intervention name(s): Dietary Nitrate; Potassium Chloride (placebo)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise.; This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: muscular strength; muscular endurance; muscular power; rowing; CrossFit; dietary nitrate
Single Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of BDM-2 in Healthy Male Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human (FIH), double-blind, placebo-controlled, randomized trial in healthy
      adult male subjects, to evaluate the safety, tolerability and pharmacokinetics (PK) of single
      ascending oral doses of BDM-2. The effect of food on the PK of a single dose of BDM-2 will
      also be evaluated.
    

Detailed description: 
      The Sponsor HIVIH is developing a new antiretroviral medicine, BDM-2, for the potential
      treatment of Human Immunodeficiency Virus (HIV). The study will investigate the safety,
      tolerability and pharmacokinetics (PK) (how well the medicine is taken up by the body) of
      single doses of the test medicine given by mouth, in healthy male volunteers. The effect of
      food on the PK of the test medicine will also be assessed.

      This is the first time the medicine will be dosed in humans. Over 6 study periods, ascending
      (increasing) doses of the test medicine or placebo (dummy drug) will be given to 16 healthy
      male volunteers in the fasted state. Alternately dosed to two groups each made up of 8
      volunteers. After each dose volunteers will remain in the clinical unit for 48 hours for
      blood samples to be taken and safety assessments to be performed.

      To investigate the effect of food, it is planned that in Period 7 the medicine will be
      administered in the fed state. On the 7th study period one of the doses administered in a
      previous period will be administered under fed conditions (with food). Each volunteer will
      receive 3 or 4 single doses of test medicine or placebo.
    

Intervention name(s): BDM-2 in Bottle (50 mg - 3600 mg); oral suspension
Intervention type(s): Drug
Intervention description(s): BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In Sessions I to VI, 6 single, orally administered ascending doses of BDM-2 or placebo will be investigated, alternately dosed in 2 cohorts of 8 healthy male subjects each (Cohorts A and B). For each dose, 6 subjects will receive active treatment and 2 subjects will receive placebo. Subjects will be randomized in such a way that for each dose different subjects receive placebo. In Sessions I to VI, doses are planned to be administered under fasted conditions.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: safety; tolerability; pharmacokinetics
A Study of the PK Interaction of CXA-10 With Pravastatin and Vytorin® in Healthy Males
Condition: Acute Kidney Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an exploratory study in a small, well controlled group of healthy subjects to explore
      the effect of CXA-10 on pravastatin and Vytorin® (combination of simvastatin and ezetimibe).
    

Detailed description: 
      This is an exploratory study in a small, well controlled group of healthy subjects to explore
      the effect of CXA-10 on pravastatin and Vytorin® (combination of simvastatin and ezetimibe).

      The overall design of the trial is to administer drugs that are metabolized through these
      transporters to quantify the impact CXA-10 may have on the exposure of these drugs.

      The study will also examine the 24-h urine total creatinine excretion prior to and following
      administration of CXA-10 to examine the effects of CXA-10, if any, either directly on
      creatinine transporters or through enhanced creatinine production.

      To reduce the potential variability in drug exposure levels, the study population will only
      include male subjects between 19 to 25 years of age.
    

Intervention name(s): CXA-10; pravastatin; Vytorin® (combination of simvastatin and ezetimibe)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid; It is statin medicine used to lower cholesterol and triglycerides in the blood.; It lowers bad cholesterol in the blood, and raises good cholesterol
Other intervention name(s): Pravachol®
Intervention MeSH terms: CXA-10; Simvastatin; Ezetimibe; Pravastatin; Ezetimibe, Simvastatin Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype
Condition: Alpha1-Antitrypsin Deficiency
MeSH terms: Alpha 1-Antitrypsin Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-864 in PiZZ
      subjects.
    


Intervention name(s): VX-864; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets for oral administration.; Placebo matched to VX-864 for oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment