bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Vaniprevir (MK-7009) With Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) in Treatment-Experienced Hepatitis C Virus (HCV) Participants (MK-7009-009)
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 test the safety, tolerability, and efficacy of 4 regimens of
      Vaniprevir + Peg-IFN and Ribavirin as compared to Placebo (PBO) + Peg-IFN/RBV. The primary
      hypotheses are that Vaniprevir is well tolerated, and that Vaniprevir 600 mg twice daily
      (b.i.d.) is superior to the control regimen for the percentage of non-cirrhotic (NC)
      participants achieving undetectable HCV ribonucleic acid (RNA) 24 weeks after the end of
      study therapy (SVR24).
    


Intervention name(s): Vaniprevir; Pegylated Interferon (Peg-IFN); Ribavirin (RBV); Placebo (PBO)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants took capsules containing 100 mg Vaniprevir twice daily (b.i.d.), three in the morning (300 mg and 600 mg regimens) and three in the evening (600 mg regimen only), orally, for 24 or 48 weeks.; Participants used prefilled syringe containing 180 µg/0.5 mL Peg-IFN, for weekly subcutaneous injection, for 24 or 48 weeks; Participants took tablets containing 200 mg RBV, 5 or 6 tablet dosage based on the participant's weight, with food, for 24 or 48 weeks. The dose was 1000 mg for participants weighing <=75 kg and 1200 mg for participants weighing >75 kg.; Participants took PBO capsules matching Vaniprevir capsules, three in the morning and three in the evening, for 24 or 48 weeks.
Other intervention name(s): MK-7009; PEGASYS™; COPEGUS™
Intervention MeSH terms: Interferons; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hepatitis C
Antibiotic Prophylaxis in Total Knee Prosthesis
Condition: Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Knee prosthesis infection is a severe complication. The use of a tourniquet during surgery
      impairs the efficacy of the antibiotic prophylaxis. We hypothesize that the antibiotic
      administration before tourniquet release decrease the infection rate. Methods: patients who
      undergo a total knee arthroplasty will be randomized to receive one of the following regimens
      of antibiotic prophylaxis:Standard: cefuroxime 1.5 g i.v. 10 min before tourniquet + placebo
      10 min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical
      wound.Experimental: cefuroxime 1.5 g i.v. 10 min before tourniquet + cefuroxime 1.5 g i.v. 10
      min before tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.
    

Detailed description: 
      Objective: when surgery is performed under ischemia, the ideal timing for the administration
      of antibiotic prophylaxis has not been well defined. Currently, antibiotics are given 10
      minutes before ischemia and the infection rate is about 3-5%. In 2005 we performed a study
      where the efficacy of the standard prophylaxis was compared with a new regimen that consisted
      in administering the antibiotic 10 min. before tourniquet release. The results were positive
      although the difference was not statistically significant. In the present study we are
      proposing a new protocol where the antibiotic is given 10 min. before the inflation of
      tourniquet and 10 min. before its release. Methodology: all patients who undergo a total knee
      arthroplasty will be randomized to receive one of the following regimens of antibiotic
      prophylaxis:Standard: cefuroxime 1.5 g i.v. 10 min before tourniquet + placebo 10 min before
      tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.Experimental:
      cefuroxime 1.5 g i.v. 10 min before tourniquet + cefuroxime 1.5 g i.v. 10 min before
      tourniquet release + cefuroxime 1'5 g i.v. 6h after closing surgical wound.The infection rate
      with standard regimen is 3.4%. We believe that the new regimen will decrease the rate of
      infection to 1%. To demonstrate differences between both arms, it will be necessary to
      include 666 patients per arm.
    

Intervention name(s): cefuroxime; placebo
Intervention type(s): Drug; Drug
Intervention description(s): cefuroxime is administered at a dosage of 1.5 g before tourniquet inflation and release in experimental arm and only before tourniquet inflation in control arm; cefuroxime 1.5 g IV before tourniquet inflation + placebo before tourniquet release + cefuroxime 1.5 g IV 6 h after surgery
Intervention MeSH terms: Cefuroxime; Cefuroxime axetil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: infection after total knee arthroplasty
Bioavailability Study of Sirolimus Tablets 2 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the Sirolimus Tablets 2 mg of Dr. Reddy's Laboratories Limited, India
      and Rapamune® (Sirolimus) tablets 2 mg of Wyeth Laboratories, Philadelphia in healthy,
      adult,human subjects under Fasting conditions.
    

Detailed description: 
      Open label, randomized, two-treatment, two-period, two-sequence, cross over, single dose,
      oral bioequivalence study of Sirolimus tablets 2 mg under Fasting conditions.
    

Intervention name(s): Sirolimus
Intervention type(s): Drug
Intervention description(s): Sirolimus tablets 2 mg
Other intervention name(s): Rapamune
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 2 Study of MD-1100 Acetate Administered for 14 Days to Patients Meeting Criteria for Chronic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and gastrointestinal pharmacodynamics
      (stool frequency, stool consistency, stool ease of passage, stool completeness of evacuation)
      of MD-1100 acetate administered daily for 14 days.
    


Intervention name(s): MD-1100 Acetate
Intervention type(s): Drug
Intervention MeSH terms: Linaclotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic Constipation; Chronic Idiopathic Constipation; Constipation; CIC; CC; MD-1100; MD-1100 Acetate; Microbia; Microbia, Inc.; linaclotide; linaclotide acetate
The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma
Condition: Biliary Tract Cancer
MeSH terms: Adenocarcinoma; Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Advanced biliary tract adenocarcinoma has a poor prognosis with limited therapeutic options.
      Nab-paclitaxel plus S-1 chemotherapy will be given to untreated patients with advanced
      biliary tract adenocarcinoma for the first-line treatment.
    

Detailed description: 
      Gemcitabine/Nab-paclitaxel has become a standard therapy in advanced pancreatic cancer. Given
      the morphologic and histologic similarities between pancreatic cancer and biliary tract
      adenocarcinoma, nab-Paclitaxel may be a promising regimen, and S-1 has been approved for
      biliary tract cancer in Japan. Untreated patients with advanced biliary tract adenocarcinoma
      will receive Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface
      area<1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface
      area>1.5 m2; D1-14, q3w) as the first-line treatment. The investigators will investigate the
      efficacy and safety of the combination treatment, and expect to provide a more effective
      treatment plan for patients with advanced biliary tract cancer in China.The primary endpoint
      is objective response rate(ORR), and the secondary endpoints are progression-free
      survival(PFS), overall survival(OS) and the safety.
    

Intervention name(s): Nab-paclitaxel,S-1
Intervention type(s): Drug
Intervention description(s): Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w)
Intervention MeSH terms: Paclitaxel
Intervention model: Single Group Assignment
Intervention model description: Patients with untreated advanced biliary tract adenocarcinoma
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nab-paclitaxel, S-1, Advanced Biliary Tract Adenocarcinoma
Pelvic Floor Muscle Exercises Effect After Stoma Closure
Condition: Stoma
Study type: Interventional

Summary: 
      This study was conducted to evaluate the effect of pelvic floor muscle exercises on bowel
      evacuation problems and quality of life in individuals after stoma closure.
    

Detailed description: 
      Sample of study was calculated as 32 using G*Power Software (ver. 3.1.9.2) for 80% power and
      medium effect size (f=0.25) at 95% confidence level in line with the data of Lin et al.
      Participants were assigned to the experimental and control groups by the stratified block
      randomization method. The locks were assigned to layers using Microsoft Excel.

      The individuals in the experimental group received pelvic floor muscle exercises training
      from the researcher using the Roy Adaptation Model in addition to routine discharge training.
      The patients received a PFME training booklet prepared by the researcher. Face-to-face
      training was given to the individuals in the experimental group on the day before the
      operation, on the second and third postoperative days, and on the day of discharge. The
      training continued with phone calls at the first, second and third weeks and the first,
      second, third, and sixth months after the surgery. Data was collected a day before discharge,
      first, second, third, and sixth months after the surgery.
    

Intervention name(s): pelvic floor muscle exercise
Intervention type(s): Other
Intervention description(s): pelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery Patients practiced exercises 6 month after surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: stoma; stoma and wound care nurse; pelvic floor exercises; bowel evacuation problems; quality of life
Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis
Condition: Relapse-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Recurrence
Study type: Observational

Summary: 
      The purpose of this study is to study the effect of fingolimod on cardiac autonomic
      regulation in patients with relapse-remitting multiple sclerosis.

      This will be done by measuring heart rate variability from the 24-hour Holter recording and
      myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings.

      The fingolimod treatment is prescribed according to the accepted drug label.
    

Detailed description: 
      The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart
      rate variability and myocardial ventricular repolarisation pattern will be done 1) before
      fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of
      fingolimod.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Neurological clinic
      
Keywords: relapse-remitting multiple sclerosis; heart rate variability; fingolimod; cardiac autonomic regulation
Effects of Kinesiology Tape Tensions on Gastrocnemius and Soleus H-reflex Modulations
Condition: Kinesiology Taping
Study type: Interventional

Summary: 
      Kinesio tape (KT) has been widely used in the areas of sports and physical therapy (Kase,
      2003). The effect of KT tensions on H-reflex modulation has not been discussed in the
      literature. This study investigated the effect of different KT tensions on the H-reflex
      modulation in the gastrocnemius and the soleus muscles.
    


Intervention name(s): Kinesiology tape
Intervention type(s): Device
Intervention description(s): Application for 0%, 50%, and 100% of maximal KT stretch to the calf muscle during lying and standing positions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: H-reflex modulation; motoneuronal excitability; Ia afferent inputs; posture; Kinesiology tape
Comparative Outcomes Assessment of the C-Leg With a New Knee Prosthesis
Condition: Other and Unspecified Complications of Amputation Stump
Study type: Interventional

Summary: 
      The purpose of this study is to determine if transfemoral amputees of varied etiology will
      demonstrate increased function, safety and quality of life following accommodation with a new
      knee prosthesis as compared to their former C-Leg knee prosthesis.
    


Intervention name(s): Otto Bock C-Leg; Otto Bock Genium
Intervention type(s): Device; Device
Intervention description(s): Amputees' preferred prosthetic knee.; Study knee.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Blogshot Formats With Standard Cochrane Plain Language Formats
Condition: Health Knowledge, Attitudes, Practice
Study type: Interventional

Summary: 
      Participants will receive in random order on format of brief description of systematic review
      summary on health intervention. One group will receive standard plain language summary, while
      another will receive Cochrane blog shot, containing only few information about the efficacy
      of the intervention. After reading, their task will be to answer several questions about the
      material they have read.
    


Intervention name(s): PLS; Blogshot
Intervention type(s): Other; Other
Intervention description(s): Participants will have to read standard textual information about the conducted systematic review (approximately 500 words); Participants will have to read the blogshot information about the results of the Cochrane systematic review (approximately 100 words)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Probiotics for Birch Pollen Allergy
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Birch pollen allergy is one of the most common forms of respiratory allergy in the Nordic
      countries. Treatment consists of antihistamine use. Specific probiotic strains have been
      observed to modulate the immune system. Since the body has a common mucosal immune system; it
      was hypothesised that consumption of probiotics may affect also the respiratory mucosal
      immune response and hence affect respiratory allergy.

      Earlier studies with probiotics had been unable to show improvements in adults with pollen
      allergy. It was therefore hypothesised that children, who's immune system is not yet fully
      developed, might be better targets.
    


Intervention name(s): Lactobacillus acidophilus and Bifidobacterium lactis; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Daily 5x10^9 CFU of a combination of L. acidophilus and B. lactis; Microcrystalline cellulose
As capsule which could be opened
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: birch pollen
A Controlled Study of Uric Acid on the Progression of IgA Nephropathy
Condition: IgA Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Interventional

Summary: 
      This prospective, randomized controlled study will evaluate the effect of uric acid on the
      progression of IgA nephropathy.
    

Detailed description: 
      It has been reported that hyperuricemia is a risk factor for progression of IgAN. This will
      be a prospective, randomized study. Eligible IgAN patients will be randomized into the
      treatment group and the control group. Patients in treatment group will receive allopurinol
      and usual therapy. Patients in control group will receive usual therapy with placebo. If with
      hypertension, add the CCB and the β-blocker. Fasting uric acid, serum creatinine, albumin,
      routine blood test, urine microscopy and dipstick, proteinuria of 24 hours and blood pressure
      will be measured every month. After followed-up for 6 months, the curative effect of
      Allopurinol on blood pressure, proteinuria and the progression of IgA nephropathy will be
      evaluated.
    

Intervention name(s): allopurinol; continue their usual therapy
Intervention type(s): Drug; Other
Intervention description(s): Patients will receive the lifestyle modification and treatment of allopurinol (300 mg /d) and lifestyle modification for 4 weeks; when the UA level < 6mg/dl , the dosage changed to 200mg/d.; Patients will receive lifestyle modification and continue their usual therapy.
Intervention MeSH terms: Allopurinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IgA nephropathy
Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel
      0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel)
      applied in the morning, in Subjects with Acne vulgaris.
    

Detailed description: 
      Same as above.
    

Intervention name(s): adapalene gel, 0.3%; clindamycin/benzoyl peroxide gel
Intervention type(s): Drug; Drug
Intervention description(s): Applied once daily at bedtime; Applied once daily in the morning
Other intervention name(s): Differin® Gel, 0.3%; Duac® Gel
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Adapalene; Benzoyl Peroxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Explore the Performance of IntelliCap.
Condition: Plasma Concentration; Pharmacokinetic Profile
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is an open-label, randomised, 4-way crossover study in twelve healthy male volunteers.

      The study will characterise the performance of IntelliCap® by evaluating the plasma
      concentration and pharmacokinetic profile of a probe drug (IMP; metoprolol) released from
      IntelliCap® with three different release profiles and the plasma concentration and
      pharmacokinetic profile of the same probe drug after a single dose of an oral solution.
    


Intervention name(s): IntelliCap
Intervention type(s): Drug
Intervention description(s): Drug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.
Other intervention name(s): IntelliCap and metoprolol
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study on the Possible Health Effects of Lean Fish, Fatty Fish and Lean Meat Intake in Non-obese Adults
Condition: Metabolic Disorders; Obesity
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat
      would affect parameters related to health in healthy non-obese adults, and will serve as
      basis for future calculation of group sizes in coming studies. Participants consumed
      750g/week of fillets of fish or meat for 4 weeks.

      Hypothesis:

      High intake of either lean or fatty fish will not affect serum concentrations of lipids and
      inflammatory markers as well as improve glucose tolerance during the 4 week intervention
      period when compared to lean meat intake.
    


Intervention name(s): Lean fish; Fatty fish; Lean meat
Intervention type(s): Other; Other; Other
Intervention description(s): Participants consumed 150g of lean fish, five times per week for 4 weeks; Participants consumed 150g of fatty fish, five times per week for 4 weeks; Participants consumed 150g of lean meat, five times per week for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
β-galactosidase Producing Probiotic Strains to Improve Lactose Digestion
Condition: Lactose Intolerance
MeSH terms: Lactose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to assess that two β-galactosidase Producing Probiotic Strains
      help improve lactose digestion in subjects with lactose maldigestion.
    

Detailed description: 
      The trial will be cross over, randomized in incomplete blocks, controlled, double-blind:

      each subject will be administered 3 products out of 4 (positive control, probiotic
      Streptococcus (S.) thermophilus, probiotic Bifidobacterium (B.) longum, negative control) in
      a random order on 3 different days separated by a washout period of at least one week, and
      maximum 2 weeks between each challenge.

      The total sample size is 42 enrolled subjects/37 completed Patients will be males and females
      aged between 20 and 65 years with positive hydrogen breath test.
    

Intervention name(s): Positive control; Probiotic S. thermophilus; Probiotic B. longum; Negative control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 200ml milk containing 18g lactose; 200ml milk containing 18g lactose + probiotic S. thermophilus; 200ml milk containing 18g lactose + probiotic B. longum; 200 ml of UHT Lactose free milk
Intervention MeSH terms: Sulfalene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care