bioihbjkbjnl/mcl2 huggingface dataset:
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of HSK21542 Injection in Subjects Undergoing Hemodialysis
Condition: Uremic Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled phase II clinical trial.
      The main objective is to evaluate the safety, pharmacokinetics, and efficacy of HSK21542
      injection in subjects undergoing hemodialysis
    

Detailed description: 
      This study is a multicenter study, which is divided into two stages. The first stage is a
      dose escalation, randomized, double-blind, placebo-controlled study of multiple intravenous
      administration within one week in hemodialysis subjects. The second stage is a randomized,
      double-blind, placebo-controlled study of Administration for 12 weeks in hemodialysis
      subjects with moderate or severe pruritus. In the second stage, consist of a Screening Visit,
      a 7-day Run-in Period, a 12 week Double-blind Treatment Period, and a 2-week Discontinuation
      Period. Informed consent will be obtained prior to performing any study-specific procedures.
      The Screening Visit will occur within 8 to 28 days prior to randomization to assess
      eligibility.
    

Intervention name(s): Stage I:HSK21542 0.05 μg/kg; Stage I:HSK21542 0.15 μg/kg; Stage I:HSK21542 0.30 μg/kg; Stage I:HSK21542 0.80 μg/kg; Stage II:HSK21542 0.3 μg/kg; Stage II:HSK21542 0.6 μg/kg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg; Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg; Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg; Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg; Randomized to HSK21542 0.3 μg/kg or 0.6 μg/kg or the corresponding placebo group; Randomized to HSK21542 0.3 μg/kg or 0.6 μg/kg or the corresponding placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a multicenter study, which is divided into two stages. The first stage is a dose escalation, randomized, double-blind, placebo-controlled study of multiple intravenous administration within one week in hemodialysis subjects. The second stage is a randomized, double-blind, placebo-controlled study of Administration for 12 weeks in hemodialysis subjects with moderate or severe pruritus.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety Study Comparing Respimat ® Budesonide With Turbohaler ® Budesonide in Symptomatic Adult Moderate to Severe Asthmatics Requiring Inhaled Corticosteroids and Bronchodilator Therapy
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      To establish that at least one of the two doses of Budesonide, as an ethanolic solution
      inhaled from the Respimat ® inhaler (100 and 200 mcg, 2 puffs bid) for a 12-week study period
      in symptomatic moderate to severe asthmatic patients, gives a therapeutic response, which is
      not inferior to that obtained from the dose of Budesonide inhaled from the Turbohaler ® (200
      mcg, 2 puffs bid) and that the safety profile is at least as good
    


Intervention name(s): Respimat® Budesonide low dose; Respimat® Budesonide high dose; Turbohaler® Budesonide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)
Condition: Neovascular Age-elated Macular Degeneration (Wet AMD); Exudative Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and efficacy of LFG316 in patients with age related macular
      degeneration.
    


Intervention name(s): LFG316; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Age-related macular degeneration; intravitreal, neovascular; anti-vascular endothelial growth factor; wet AMD; Age-related; Macular degeneration; Intravitreal; Neovascular
Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia
Condition: Postprandial Hypoglycemia
MeSH terms: Hypoglycemia
Study type: Interventional

Summary: 
      It has been proposed that the rapid gastric emptying of carbohydrate containing fluids into
      the intestine causes hyperglycemia followed by reactive hypoglycemia. The investigators have
      shown that glucagon-like peptide-1 (GLP-1) secretion in response to a glucose load is
      increased in children with Post-prandial hypoglycemia (PPH). This is a proof of concept study
      to investigate the causative role of GLP-1 in the pathophysiology of PPH after fundoplication
      by evaluating the effects of GLP-1 receptor antagonism on metabolic variables after a mixed
      meal.

      Hypothesis: In children with post-prandial hypoglycemia after fundoplication, antagonism of
      the GLP-1 receptor by exendin-(9-39) will elevate nadir blood glucose levels after a meal
      challenge and prevent post-prandial hypoglycemia.
    

Detailed description: 
      PPH is a frequent complication of fundoplication in children. The mechanism responsible for
      the PPH is poorly understood, but involves an exaggerated insulin response to a meal and
      subsequent hypoglycemia. We have shown that children with PPH after Nissen fundoplication
      have abnormally exaggerated secretion of GLP-1, an incretin hormone with multiple glucose
      lowering effects including stimulation of insulin secretion and suppression of glucagon
      secretion. In this study we seek to examine the causal role of endogenous GLP-1 in PPH after
      fundoplication by evaluating the effects of antagonizing the GLP-1 receptor with
      exendin-(9-39) on key metabolic features of PPH.
    

Intervention name(s): Exendin-(9-39); Vehicle
Intervention type(s): Drug; Other
Intervention description(s): IV infusion of exendin-(9-39) for 5 hours; Normal saline (vehicle) infusion for 5 hours at 0.06 mL/kg/hr
Other intervention name(s): Normal Saline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Post prandial hypoglycemia; hypoglycemia; Nissen fundoplication; Dumping
The Treatment of Initial Stage of Hip Osteonecrosis: the Core Decompression
Condition: Hip Necrosis; Hip Injuries
MeSH terms: Necrosis; Hip Injuries
Study type: Interventional

Summary: 
      This retrospective study evaluates 52 cases of avascular necrosis of femoral head (AVN)
      treated by core decompression, bone chips allograft, fibrin platelet rich-plasma (PRF) and
      concentrated autologous mesenchymal stromal cells (MSCs).
    

Detailed description: 
      We report 52 cases of avascular necrosis of the hip (AVN), operated by decompression of the
      necrotic area with bone chips allograft, adjuvanted by concentrated autologous mesenchymal
      stromal cells (MSCs) and fibrin platelet rich-plasma (PRP).

      The patients were followed-up at 6 weeks, 3 months, 6 months, 12 months, 24 months and then
      every year. Each time a clinical evaluation by Harris Hip Score (HHS) was carried out by the
      same orthopedic surgeon. Radiological controls (pelvis and hip affected) were performed at 6
      weeks, 3 months, 6 months, 12 months, 24 months and then every year.

      The primary outcome evaluated was the avoiding or delaying of total hip replacement (THR),
      while the secondary outcomes were the assessment of any change in clinical performance as
      measured by Harris Hip Score
    

Intervention name(s): Core decompression procedure
Intervention type(s): Procedure
Intervention description(s): Core Decompression with Bone Chips Allograft adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS), isolated from Bone Marrow
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hip avascular necrosis; hip conservative surgery
A Study of Weekly Taxotere and Xeloda in Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to attempt to find better tolerated doses and schedules of this
      highly effective combination chemotherapy regimen.
    

Detailed description: 
      Combination chemotherapy has advantages over monochemotherapy due to the higher response
      rates that can often be obtained; by using agents with non-overlapping toxicity profiles,
      these responses can be achieved with less toxicity than maximally tolerated doses of single
      agents. One significant advantage of capecitabine/weekly docetaxel combination chemotherapy
      is that both agents appear to have a toxicity profile appropriate for palliative therapy of
      advanced breast cancer. This trial will utilize the usual schedule of capecitabine used in
      the USA, which is two times per day oral dosing for 14 days but at a reduced dose in hopes of
      decreasing toxicities. Docetaxel will be given weekly at a dose of 35 mg/m2 X 2 with a
      one-week rest to coincide with the 14-day schedule of capecitabine.

      The primary objective is to evaluate the overall response rate (complete and partial
      responses) according to the RECIST criteria of the combination of capecitabine and docetaxel
      with the selected schedule in patients with advanced and/or metastatic breast cancer. The
      secondary objectives are to evaluate tolerability, time to tumor progression, and time to
      treatment failure of the combination of capecitabine and docetaxel.
    

Intervention name(s): docetaxel, capecitabine
Intervention type(s): Drug
Intervention description(s): cohort 1 = capecitabine 900mg/m2 BID POx14 days and docetaxel 36mg/m2 day1&8 cohort 2 = capecitabine 650mg/m2 BID POx14 days and docetaxel 30mg/m2 day1&8 cohort 3 = capecitabine 850mg/m2 BID POx14 days and docetaxel 30mg/m2 day1&8
Intervention MeSH terms: Docetaxel; Capecitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic Breast Cancer; Taxotere (docetaxel); Xeloda (capecitabine)
Monitoring of Cerebral Autoregulation in Pediatric ECMO (ECMOX 1)
Condition: Extracorporeal Membrane Oxygenation Complication
Study type: Observational

Summary: 
      Children supported by Extra-Corporeal Membrane Oxygenation (ECMO) present a high risk of
      neurological complications and cerebral autoregulation (CA) impairment may be a risk factor.
      Our first objective is to investigate the feasibility of CA continuous monitoring during ECMO
      treatment. The second objective is to analyze the relationship between CA impairment and
      neurological outcome.
    

Detailed description: 
      Patients : All children treated by ECMO in the PICU of the Universitary hospital of Nantes,
      France and of IRCCS Giannina Gaslini Institute, Genoa, Italy

      Measurements: A correlation coefficient between the variations of regional cerebral oxygen
      saturation (rScO2) as a surrogate of cerebral blood flow and the variations of arterial blood
      pressure (ABP) is calculated as an index of autoregulation (cerebral oxygenation index (COx),
      ICM+ software®). CA is monitored either on left (COxl) or both sides. A COx > 0.3 is
      considered as critical. Neurological outcome is assessed by the onset of an acute neurologic
      event (ANE) during the ECMO run.
    

Intervention name(s): ECMO for hemodynamic or respiratory indication
Intervention type(s): Other
Intervention description(s): ECMO for hemodynamic or respiratory indication
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients from 0 to 18 years treated by ECMO
      
Keywords: ECMO; cerebral autoregulation
Dietary Methionine and Cysteine Restriction in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      Studies in laboratory models indicate that dietary methionine restriction (MR) enhances
      longevity and produces short- and long-term metabolic changes that are consistent with a
      healthy lifespan. The present study was designed to establish levels of dietary methionine or
      methionine and cysteine that induce physiological changes in healthy adults like those
      observed in rodent studies .
    

Detailed description: 
      In this controlled feeding study, subjects will be randomized to one of two experimental.
      Group A (N=10): will start with control diet (31 mg/kg/day Met; 31 mg/kg/day Cys) for 4 weeks
      followed by a washout for 3-4 weeks, then a 70% MR diet (9.3 mg/kg/day Met; 40.3 mg/kg/day
      SAA) for 4 weeks, followed by 3-4 weeks washout period and then a 90% MR diet (3.1 mg/kg/day
      Met; 34.1 mg/kg/day SAA) for 4 weeks. Group B (N=10): will start with control diet (31
      mg/kg/day Met; 31 mg/kg/day Cys) for 4 weeks followed by a washout for 3-4 weeks then a 50%
      methionine and cysteine restricted (M/CR) diet (15.5 mg/kg/day Met; 15.5 mg/kg/day Cys; 31
      mg/kg/day SAA), followed by 3-4 weeks washout period and then a 65% M/CR diet (10.8 mg/kg/day
      Met; 10.8 mg/kg/day Cys; 21.6 mg/kg/day SAA) for 4 weeks.
    

Intervention name(s): Sulfur amino acid restricted diet
Intervention type(s): Other
Intervention description(s): Methionine restricted diet: 70% or 90% restriction Methionine and cysteine restricted diet: 50% or 65% restriction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: methionine; cysteine; sulfur amino acid restriction
Very Early Versus Delayed Etanercept in Patients With RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      The main aim of the study is to determine whether TNFi instituted as first-line therapy in
      early RA confers better outcomes (clinical, structural and immunological) compared to delayed
      TNFi start; implying particular dominance of TNF in early disease, a changing role of TNF
      with disease duration and hence, confirmation of a biological window of opportunity.
    


Intervention name(s): Etanercept; Methotrexate; Sulfasalazine; Hydroxychloroquine; Etanercept; Methotrexate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Etanercept will be administered subcutaneously at a dose of 50 mg weekly and will be discontinued at the primary endpoint (48 weeks).; Methotrexate will be administered orally at a starting dose of 15 mg and will be increased to 25mg weekly at 2 weeks.; Sulfasalazine will be added at weeks 8,12,16 or 20 if the subject fails to achieve low disease activity, administered orally at a dose of 1g twice daily. Will be discontinued if starting etanercept at 24 weeks.; Hydroxychloroquine will be added at weeks 8,12,16 or 20 if the subject fails to achieve low disease activity, administered at a dose of 200mg daily. Will be discontinued if starting etanercept at 24 weeks.; Etanercept will be added at 24 weeks, if a subject fails to achieve clinical remission,at a dose of 50 mg weekly and will be discontinued at 48 weeks with the exception of those patients who are eligible to continue according to local prescribing guidelines (NICE guidelines); Methotrexate will be administered orally at a starting dose of 15 mg weekly, increasing to 20mg and 25mg weekly at weeks 4 and 8 respectively.
Intervention MeSH terms: Hydroxychloroquine; Sulfasalazine; Etanercept; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Etanercept; treat to target; Disease Modifying Antirheumatic Drugs (DMARDs)
Reproducibility of Glucose Fluctuations by Standardized Exercise for Patients With Type 1 Diabetes - a Method Study Based on Continuous Glucose Monitoring
Condition: Diabetes Mellitus, Type 1; Exercise; Continuous Glucose Monitoring
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The purpose of this project is to investigate whether the glucose response in type 1 diabetes
      patients measured using Continuous Glucose Monitoring measurement is reproducible in repeated
      standardized test sessions that include physical activity.
    


Intervention name(s): Blood glucose measured using CGM during standardized physical activity
Intervention type(s): Behavioral
Intervention description(s): Standardized exercise on bicycle at 70% of the participants work capacity for ½ hour.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        20 patients with type 1 diabetes (treated with or without insulin pump) will participate in
        three identical test sessions on an exercise bike. During the three test sessions, patients
        will be monitored by heartrate, blood glucose (obtained by lancet) and CGM. The
        participants will also be using a diary for registration of diet as well as exercise during
        the study.
Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This open label study is designed to assess long term glucose control, as measured by
      hemoglobin A1c (HbA1c) and to evaluate long term safety and tolerability in subjects with
      type 2 diabetes mellitus who receive subcutaneously injected exenatide administered twice a
      day.
    


Intervention name(s): exenatide
Intervention type(s): Drug
Intervention description(s): subcutaneous injection, 5 mcg, twice a day for 4 weeks (transition period), then 10 mcg twice a day till study termination
Other intervention name(s): Byetta; exendin-4; AC2993
Intervention MeSH terms: Exenatide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exenatide; diabetes; Amylin; exendin-4
MyHealthCheckup Wellness Program Among Canadian Forces Military Personnel
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      This research is collecting data to determine the benefits of a web-based wellness program
      designed to improve the health and well-being of individuals in the workplace. Participants
      will be invited to participate in a web-based Healthy Weight Program. The program is designed
      to optimize health and wellbeing by promoting physical activity and healthy eating.
    


Intervention name(s): Web-based weight loss program; On-line health coaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 4-week web-based wellness program.; A 4-week web-based wellness program with weekly personalized on-line health coaching.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weight loss; healthy weight; overweight; body mass index greater that 25 kg/m2
Clinical Test Report for Blood Pressure Meter CH-609
Condition: Blood Pressure
Study type: Observational

Summary: 
      Blood pressure meter model CH-609 was to be assessed against the standard mercury
      sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Community Sample
      
Keywords: Blood Pressure
A Global Assessment of Medical, Emotional and Reproductive Concerns in Gestational Trophoblastic Disease Survivors
Condition: Uterine Cancer; Cervix Uteri Nos; Gestational Trophoblastic Disease
MeSH terms: Uterine Neoplasms; Gestational Trophoblastic Disease
Study type: Observational

Summary: 
      The purpose of this study is to collect information on the effects of treatment for
      gestational trophoblastic disease (GTD). We plan to use the findings from this study to
      better understand GTD survivors' health and quality of life.

      We would like to know more about the health, quality of life and pregnancies of women treated
      for GTD. This information will be used to try and improve the treatments for women who have
      this disease.
    


Intervention name(s): questionnaire; questionnaire
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A patient questionnaire, which includes validated instruments. Data collection methods are as follows:
In person at the medical appointment
Over the telephone
Mailed with self-addressed return envelope and prepaid postage
E-mailed and returned by e-mail, fax or self-addressed envelope and pre-paid postage; A patient questionnaire, which includes validated instruments. Data collection methods are as follows:
In person at the medical appointment
Over the telephone
Mailed with self-addressed return envelope and prepaid postage
E-mailed and returned by e-mail, fax or self-addressed envelope and pre-paid postage
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        GTD survivors treated at Memorial Sloan-Kettering Cancer Center (MSKCC).
      
Keywords: GTD survivors; questionnaires; GTD