bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.
Condition: Pulmonary Arterial Hypertension, Children
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a clinical research study designed to evaluate sildenafil for the treatment of
      Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is
      to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with
      oral sildenafil given in three different doses, compared to placebo (inactive treatment).
      Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may
      be eligible to take part in an extension study, in which all patients will receive active
      treatment of sildenafil.
    


Intervention name(s): Sildenafil citrate; Sildenafil citrate; Placebo; Sildenafil citrate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral; 20mg, 40mg and 80 mg; 3 times a day(TID); oral; 10mg, 20mg and 40mg; 3 times a day(TID); oral; 3 times a day(TID); oral; 10 mg; 3 times a day(TID)
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Second Study to Determine the Effect of GSK256073A on HVTs
Condition: Healthy Subjects; Dyslipidaemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the effects of single and repeat doses of GSK256073
      with placebo in HVT subjects that have been administrated GSK256073 in the HMA107787 study
    


Intervention name(s): GSK256073A tablets
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: GSK256073A
Feasibility Study of Metformin Therapy in ADPKD
Condition: Polycystic Kidney, Autosomal Dominant
MeSH terms: Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to determine if treatment with metformin, a drug widely used for the
      treatment of diabetes type 2, is safe and well tolerated by individuals with Autosomal
      Dominant Polycystic Kidney Disease (ADPKD) who are not diabetic and who have slightly
      decreased kidney function. The study will also evaluate the effects of metformin on kidney
      growth and kidney function.
    

Detailed description: 
      Patients with ADPKD are still in need for a well-tolerated treatment that can be used
      long-term to prevent cyst growth and kidney function decline. Metformin has a long track
      record of a low risk-to-benefit profile in patients with diabetes or at risk for diabetes.
      Metformin inhibits two key processes responsible for the growth of polycystic kidneys, i.e.
      fluid secretion and cell proliferation, as shown in cell cultures and animal models of ADPKD.
      Experiments in animal models of chronic kidney disease demonstrate that metformin
      administration prevents kidney fibrosis and preserves kidney function. Diabetic patients who
      are treated with metformin appear to develop less kidney failure and live longer than
      patients who are treated with other anti-diabetic medications. Therefore this drug is
      promising for people with ADPKD, with the potential to slow cyst enlargement and preserve
      kidney function.
    

Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Monitoring of safety and tolerability; Monitoring of safety and tolerability
Other intervention name(s): Glucophage; Fortamet; Glumetza
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metformin; total kidney volume; glomerular filtration rate
Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This is a randomized controlled trial to evaluate the clinical efficacy of combined
      electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult
      population in Hong Kong.
    

Detailed description: 
      Combined electro-acupuncture and auricular acupuncture is potential to be an alternative
      treatment for primary insomnia. The purpose of this study is to evaluate the clinical
      effectiveness of combined electroacupuncture and auricular acupuncture on persistent
      insomnia. This is a randomized double-blinded controlled trial. Patients will be randomly
      assigned to the electro-acupuncture group, the electro-acupuncture plus auricular acupuncture
      group or the waitlist controlled group. Patients will be put into groups and then
      compared.The chance of getting into each group is 3:3:1.
    

Intervention name(s): Acupuncture plus auricular acupuncture; Acupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Aricular acupuncture at Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex.In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours.; Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
Other intervention name(s): Acupuncture; Electroacupuncture; Electroacupuncture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Acupuncture; Electroacupuncture; Aricular acupuncture; Randomized Clinical Trial; Traditional Chinese Medicine
Comparison of Analgesic Efficacy of Fentanyl, Sufentanil and Butorphanol After Remifentanil Anesthesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Fast awakening from anesthesia is one of the major characteristics of remifentanil-associated
      anesthetic induction and maintenance, whereas corresponding pain during awakening influences
      patient's rehabilitation strongly. In addition, such early postoperative pain results in
      significant stress responses, which displays as further release of stress hormones such as
      cortisol and β-endorphin as well. How to prevent such acute pain resulting from
      remifentanil's fast metabolism endows clinical significance. This study is designed to
      compare the analgesic efficacy of fentanyl, sufentanil and butorphanol delivered after
      gynecological laparoscopic surgeries that underwent remifentanil induction and maintenance,
      and investigate corresponding influence on the levels of blood cortisol and β-endorphin.
    


Intervention name(s): Fentanyl citrate; Sufentanil citrate; Butorphanol tartrate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fentanyl 0.5 μg/kg delivered intravenously immediate at the end of remifentanil pump finished; Sufentanil 0.05 μg/kg delivered intravenously immediate at the end of remifentanil pump finished; Butorphanol 0.01 mg/kg delivered intravenously immediate at the end of remifentanil pump finished
Other intervention name(s): Fentanil; Sufenil; Nuoyung
Intervention MeSH terms: Fentanyl; Sufentanil; Dsuvia; Butorphanol; Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative analgesia; Opioids; Laparoscopic surgery
Doxorubicin and Cyclophosphamide Followed by Paclitaxel, Trastuzumab, and Lapatinib in Treating Patients With HER2/Neu-Overexpressed Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to study a new treatment for HER-2/neu (+) breast cancer.
    


Intervention name(s): trastuzumab; cyclophosphamide; doxorubicin hydrochloride; lapatinib ditosylate; paclitaxel; laboratory biomarker analysis
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Other
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Trastuzumab; Lapatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; male breast cancer
Trial on Short-chain Fructooligosaccharides, Microbiota, and Constipation in Adults
Condition: Functional Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Rationale: The dietary short-chain fructooligosaccharides have been shown to increase fecal
      bacterial mass and fermentation metabolites which might stimulate gut motility. Therefore,
      these dietary non-digestible carbohydrates might relieve functional constipation.

      Objective: Study the effect of short-chain fructooligosaccharides on functional constipation.

      Study design: A 16-week, randomized, placebo-controlled, double-blind cross-over trial with
      intervention periods of 4 weeks with a run-in period of 4 weeks and a wash-out period of 4
      weeks.

      Study population: Human subjects with functional constipation according to ROMEIII criteria
      (total n=120; male and female; 18-75 yr).

      Intervention: Placebo and one out of 3 dosages of short-chain fructo-oligosaccharides,
      (Degree of Polymerisation of 3-5; 2, 4 and 8 g/day) for 4 weeks. scFOS will be given as oral
      chews.

      Main study parameters: The primary parameter is the number of complete bowel movements per
      day in subjects with functional constipation according to Rome III criteria. Secondary
      outcomes are Stool consistency (Bristol Stool Scale), Stool frequency, Severity of symptoms
      (Constipation Scoring System; CSS) and Quality of Life (Patient Assessment of Constipation
      Quality of Life; PAC-QoL).
    


Intervention name(s): sc-FOS 2g/day; sc-FOS 4g/day; sc-FOS 8g/day; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Chewing tablets containing Short-chain fructooligosaccharides 2g/day; Chewing tablets containing short-chain Fructooligosaccharides 4g/day; Chewing tablets containing short-chain Fructooligosaccharides 8g/day; Chewing tablets without short-chain Fructooligosaccharides
Other intervention name(s): FOS; Oligofructose; scFOS; Short-chain fructo-oligosaccharide; FOS; Oligofructose; scFOS; Short-chain fructo-oligosaccharide; FOS; Oligofructose; scFOS; Short-chain fructo-oligosaccharide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Bifidobacteria; Bristol Stool Scale; Constipation; Diet; Fructooligosacchardes; Microbiota; Oligofructose
Value of Patch Testing in Direct Diet Therapy for Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional

Summary: 
      This study is being done to see if allergy patch testing (APT) can help predict effective
      dietary therapy in patients with eosinophilic esophagitis.
    

Detailed description: 
      Patients are referred to Mayo Clinic Rochester with an establish diagnosis of EoE and are
      nonresponsive to proton pump inhibitor (PPI) medical therapy. Eligible patients will then
      meet with one of three investigators complete the Mayo Dysphagia Questionaire-30 Day (MDQ-30)
      following which a standardized Allergy Patch testing (APT) will be conducted. Thereafter, a
      standard clinically indicated Six Food Elimination Diet treatment completed. Patients will
      follow up with one of three investigators following the elimination diet who will be blinded
      to the results of the APT. During this visit responders and nonresponders will be identified
      and nonresponders will complete a directed elimination diet based on APT results.
    

Intervention name(s): Allergy Patch Testing
Intervention type(s): Device
Other intervention name(s): APT; Patch testing; Allergy testing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Allergy Patch testing; Eosinophilic Esophagitis; EoE
Blood Flow Restriction on Functional Mobility in Pre-frail Older Adults
Condition: Frailty
MeSH terms: Frailty
Study type: Interventional

Summary: 
      This study investigates the effect of blood flow restriction with resistance exercise on
      functional mobility in pre-frail older adults. It is hypothesized that receiving resistance
      exercise with blood flow restriction will exhibit better improvement on functional mobility
      than only receiving resistance exercise in pre-frail older adults.
    

Detailed description: 
      Participants aged over 65 years old with less than two items positive of Fried frailty
      phenotype assessment result will be recruited. The participants will be randomly assigned to
      two training groups, blood flow restriction resistance exercise and traditional resistance
      exercise. Both groups will receive the training 30 minutes/session, two sessions/week for six
      weeks. Muscle strength of the lower extremities and functional mobility tests will be used to
      assess outcomes at pre-training, 3-week after training, post-training, and one-month and
      two-month follow-up.
    

Intervention name(s): Resistance exercise on the lower extremities; Resistance exercise on the lower extremities with blood flow restriction
Intervention type(s): Other; Other
Intervention description(s): Resistance exercise mainly on the lower extremities will be executed by carrying weight according to each participant's tolerance while performing certain movements, such as side step-up, sit-to-stand, and tip-toe-standing.; Blood flow restriction on the thigh of the dominant leg will be used in combination with resistance exercise.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pre-frail, blood flow restriction, functional mobility
Pharmacokinetic, Safety and Immunogenicity Study of CMAB809 and Herceptin in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blinded, controlled Phase I study of CMAB809 administered by
      intravenous infusion. This study will characterize the pharmacokinetic, safety and
      immunogenicity of CMAB809 versus Trastuzumab(Herceptin) in healthy male subjects after a
      single dose.
    


Intervention name(s): CMAB809; Trastuzumab
Intervention type(s): Drug; Drug
Intervention description(s): CMAB809 will be administered by IV infusion at a single dose of 6mg/kg.; Trastuzumab will be administered by IV infusion at a single dose of 6mg/kg.
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Early Albumin Resuscitation During Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: To determine whether the early administration of albumin as an expander and
      antioxidant would improve survival on the 28th day for septic shock patients.

      Design: Prospective, multicenter, randomized, controlled versus saline, stratified on
      nosocomial infection and center.

      Setting: 27 Intensive Care Units (ICU) in France

      Coordinator: Pr J.P. Mira and Dr J. Charpentier - Cochin Hospital- Paris

      Patients: 800 patients could be included during the first 6 hours of their septic shock.
    

Detailed description: 
      The primary outcome: Mortality during the 28 day period after randomization. The secondary
      outcomes: Evaluation of SOFA score, ventilator-free days, dialysis free days, catecholamine
      free days, days of hospitalisation, incidence of nosocomial infections.

      The albuminemia of all patients is requested before the treatment until Day 4 post treatment.

      The treatment is: Vialebex 20% 100ml every 8 hours during 3 days versus saline 100ml every 8
      hours during 3 days.

      The first patient will be in July 2006, the last patient expected is on July 2009.
    

Intervention name(s): albumin; saline
Intervention type(s): Drug; Drug
Intervention description(s): albumin 20% 100 ml/8 hours for 3 days; saline 100 ml/8hours for 3 days
Other intervention name(s): Vialebex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Septic Shock
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability, and immunogenicity of
      ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in
      Japan.
    


Intervention name(s): ACC-001; QS-21; QS-21
Intervention type(s): Biological; Other; Other
Intervention description(s): IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12; IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12; IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12
Intervention MeSH terms: Saponin QA-21V1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Smart City Active Mobile Phone Intervention (SCAMPI)
Condition: Physical Activity
Study type: Interventional

Summary: 
      Physical inactivity is still a major public health problem. Active transportation i.e.
      walking or cycling for transport can contribute to greater total physical activity. The
      specific aim of this study is to evaluate if a 12-week mobile phone application can increase
      time spent in active transportation (cycling or walking) and in moderate-to-vigorous physical
      activity in Swedish adults aged 20-65 years.
    


Intervention name(s): Mobile phone based intervention
Intervention type(s): Behavioral
Intervention description(s): Participants will receive supporting messages through a mobile phone based intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
ACP-196 Versus Placebo in Subjects With Rheumatoid Arthritis on Background Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is evaluating the safety, pharmacokinetics (PK), pharmacodynamics (PD) and
      efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background Methotrexate.
    

Detailed description: 
      A multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial.
      The on-treatment period is 4 weeks with weekly visits to the clinic, followed by a 4-week
      safety follow-up period after the last dose of ACP-196/placebo. The study was to evaluate the
      safety, PK, PD, and efficacy of ACP-196 in subjects with Rheumatoid Arthritis on background
      Methotrexate
    

Intervention name(s): acalabrutinib; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): methotrexate; methotrexate
Intervention MeSH terms: Methotrexate; Acalabrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acalabrutinib
Pulse Pressure Variation (PPV) to Predict Fluid Responsiveness During Cardiac Displacement in Patients Undergoing Off-pump Coronary Artery Bypass Surgery (OPCAB)
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease
Study type: Interventional

Summary: 
      Pulse pressure variation (PPV) known as a dynamic preload index is increasingly being used
      for guide of fluid management under various clinical situations. We hypothesized that PPV
      could play a role as a predictor of fluid responsiveness during displacement of the heart in
      patients undergoing off-pump coronary artery bypass surgery (OPCAB).
    

Detailed description: 
      The aim of this study was to investigate the ability of PPV to predict fluid responsiveness
      during displacement of the heart in patients undergoing off-pump coronary artery bypass
      surgery. After anesthesia, we will measure mean arterial pressure, heart rate, central venous
      pressure, mean pulmonary artery pressure, pulmonary arterial occlusion pressure, mixed venous
      oxygen saturation, PPV and cardiac index in patients receiving elective OPCAB. All parameters
      will be recorded at 5 minutes after the left anterior descending artery anastomosis,
      immediately after the displacement of the heart for the left circumflex artery anastomosis,
      and 10 minutes after fluid loading with hydroxyethyl starch 6%(10 mL/kg). Patients whose
      cardiac index increased by >15% to fluid loading will be defined as responders. To test the
      abilities of central venous pressure, pulmonary artery occlusion pressure and PPV to predict
      fluid responsiveness during heart displacement, areas under the receiver operating
      characteristics curves of the responders will be calculated and compared.
    

Intervention name(s): fluid loading
Intervention type(s): Procedure
Intervention description(s): fluid loading will be performed by using 6% hydroxyethyl starch solution , at 10 mL/kg.
Other intervention name(s): HES 130/0.4; Voluven; Fresenius Kabe, Stans, Switzerland
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention