bioihbjkbjnl/mcl2 huggingface dataset:
Rehabilitation to Patients Over 65 Years Undergoing THA
Condition: Hip Arthroplasty
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patients over 65 years do not have a self care ability the surgery benefits them.

      The aim of this study is development of a rehabilitation program based on patients'
      self-rated health.

        1. A cross section study including 600 patients

        2. RCT including 160 patients
    

Detailed description: 
      Fase 1: 600 patients waiting for or already having received total hip-/knee-replacement
      participated in a questionnaire study using SF- 36. The aim was to document self-rated health
      among this population.

      Fase 2: Results from the cross section study form the base for the RCT, where 160 patients
      over 65 years undergoing THR, 80 patients are in an intervention group and 80 patients in a
      control group. A nurse intervention program is tested, and results from the study will form
      the base for a structured rehabilitation program.
    

Intervention name(s): interview and advising; 3 follow up interviews and personal advising; interview SF-36 self rated health
Intervention type(s): Procedure; Behavioral; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Other
Keywords: selfrated health,; SF-36,; rehabilitation,; total hip replacement,; patients above 65
A Study to Assess the Bioavailability of Oral Sodium Oligo-mannurarate (GV-971) in Healthy Chinese Male Subjects
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the Bioavailability for GV-971 capsules of 150 mg, 300mg, and 450mg after
      administration of single oral doses of 900mg in healthy Male subjects.
    


Intervention name(s): GV-971; Placebos
Intervention type(s): Drug; Drug
Other intervention name(s): Sodium Oligo-mannurarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Restricting Blood Flow in Improving Muscle Strength in Patients With Hemophilic Arthropathy
Condition: Hemophilia
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Background. The main physical sequela of patients with hemophilia is the development of a
      progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This
      sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and
      periarticular muscle atrophy.

      Objective. To assess the safety and effectiveness of an intervention through blood flow
      restriction, regarding the frequency of bleeding and the improvement in the perception of
      muscle activation and strength, functionality, joint pain, joint status and the perception of
      quality of life in patients with hemophilic arthropathy. knee and ankle.

      Study design. Randomized, multicenter, single-blind clinical study. Method. 20patients with
      hemophilia A and B will be recruited in this study. Patients will be recruited in 3 regions
      of Spain. The dependent variables will be: bleeding frequency (self-registration), pain
      (measured with the visual analog scale), joint status (Hemophilia Joint Health Score scale),
      strength (dynamometer) and range of motion (goniometer). Three evaluations will be carried
      out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.

      Expected results. Observe the safety of blood flow restriction in hemophilia patients. To
      analyze the efficacy of blood flow restriction in improving muscle strength, joint pain,
      range of motion, and joint damage in patients with hemophilic knee and ankle arthropathy.
    


Intervention name(s): Blood flow restriction
Intervention type(s): Other
Intervention description(s): The intervention protocol will be carried out under the same environmental conditions and, as far as possible, at the same time. The intervention will last 4 weeks, with a periodicity of 3 weekly sessions. In total there will be 12 sessions that will last between 15 and 30 minutes depending on the number of joints affected.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hemophilic arthropathy; Blood flow restriction; Physiotherapy; Muscular strength; Muscle activation; Chronic pain; Functionality; Quality of life
Imaging Whole Coronary Artery With Intravascular Ultrasound (Ivus) And Imap For Plaque Tissue Composition In Patients With Acute Myocardial Infarction
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The iWONDER trial has the following objective:

      To analyze the morphological, phenotypic and tissue characteristics of atherosclerotic
      plaques angiographically considered "culprit" and "not-culprit" in patients undergoing
      coronary angiography due to STEMI (ST-elevation myocardial infarction).
    

Detailed description: 
      Coronary artery angiography (CA) is a two-dimensional silhouette of the arterial lumen from a
      complex three dimensional vascular structure. This exam has several limitations already well
      documented, including shortening of the vessel, overlapping images, intra and inter-observer
      variability during the consideration of the severity of injuries. Besides, it offers great
      limitations in the diagnosis of the composition of atherosclerotic plaque. Furthermore,
      intravascular ultrasound (IVUS) provides a sensitive and reproducible measure of the
      dimensions of the vessel and allows direct visualization of the vessel wall, atherosclerotic
      plaque and arterial lumen. The utility of grayscale IVUS as prognostic tool and as a guide in
      percutaneous coronary interventions (PCI) is well established. More recently, IVUS has also
      provided new insights for safety and efficacy of drug eluting stent (DES).

      Advances in technology now allow IVUS to characterize the morphology and composition of
      plaques. Specifically, the analysis of the IVUS wave frequency - beyond the interpretation of
      wave lengths used in grayscale IVUS- enables in vivo analysis of atherosclerotic plaque
      composition with high sensitivity and specificity. Although previous studies have reported
      data using IVUS radiofrequency analysis, the use of a new modality (iMapTM, Boston
      Scientific, Santa Clara, CA, USA) for characterization of atherosclerotic plaque is poorly
      known.
    

Intervention name(s): iMAP
Intervention type(s): Device
Intervention description(s): IVUS and iMAP analysis for acute coronary syndromes
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: IVUS; iMAP; Catheterization; Acute Coronary Syndrome
Comparison of Pharmacokinetic (PK) and Pharmacodynamic(PD) of Biocon Insulin 70/30 and Humulin® 70/30
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      Two-centre, randomised, double-blind, single dose, two-treatment, two-period, two sequence,
      crossover, 24-hour euglycaemic glucose clamp trial in healthy subjects.
    

Detailed description: 
      The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence
      of Biocon Insulin 70/30 with Humulin® 70/30 in healthy subjects The treatment consists of one
      single dose of the test or reference product, administered during each of the two study
      periods, separated by 5-7 days between dosing. The planned trial duration for each subject is
      about 12 to 36 days.

      Eligible subjects will undergo two 24-hour euglycaemic clamp examinations, one after
      administration of the test product and one after administration of the reference product in
      random order.
    

Intervention name(s): Humulin ®70/30; Biocon Insulin 70/30
Intervention type(s): Biological; Biological
Intervention description(s): Humulin® 70/30 is a premixed suspension of human insulin of recombinant deoxyribonucleic acid (rDNA)origin, which contains 30% short-acting human soluble insulin and 70% intermediate-acting isophane insulin.
Human insulin is produced by recombinant deoxyribonucleic acid (rDNA), technology utilizing a non-pathogenic laboratory strain of Escherichia coli.; Biocon Insulin 70/30 is a premixed suspension of human insulin of recombinant deoxyribonucleic acid (rDNA)origin, which contains 30% short-acting human soluble insulin and 70% intermediate-acting isophane insulin.
Biocon insulin is produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing a non-pathogenic laboratory strain of Escherichia coli.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Propellers Flaps for Meningomylocele Defects
Condition: Meningocele; Meningomyelocele
MeSH terms: Meningomyelocele; Spina Bifida Cystica; Meningocele
Study type: Interventional

Summary: 
      To evaluate reliability of free style propeller perforator flap for coverage MMC soft tissue
      defect follow a well-established step that overcome the usual problem of pedicled perforators
      propellers flaps.
    

Detailed description: 
      Meningomyelocele is a serious congenital birth defect that not only affect mortality and
      morbidity of neonate but also a lifelong health problem.

      The estimated incidence of spina bifida is 1-2 cases per 1000 population. Meningomylocele
      soft tissue defect reconstruction is considered a lifesaving procedure , the ideal coverage
      technique should be time limited , reliable and allow healing line to be away from repair of
      the dura . all of these criteria are available in the selection of free style propeller
      perforator flap as a method of reconstruction.
    

Intervention name(s): Freestyle pedicled perforators propellers flaps for meningomyelocele defects
Intervention type(s): Procedure
Intervention description(s): Freestyle pedicled perforators propellers flaps for meningomyelocele defects reconstruction with sequential advance in perforators dissection, large number cases, and detailed successful technique.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Reconstructive Surgical Procedures / adverse effects; Meningomyelocele / surgery
Safety and Efficacy of Long-Term Treatment With Atorvastatin in Patients With Primary Biliary Cirrhosis
Condition: Primary Biliary Cirrhosis; Hypercholesterolemia
MeSH terms: Liver Cirrhosis; Liver Cirrhosis, Biliary; Hypercholesterolemia; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary biliary cirrhosis (PBC) is frequently associated with hypercholesterolemia and
      possibly with an increased cardiovascular morbidity and mortality. Statins lower serum
      cholesterol levels and may thus improve the cardiovascular risk in PBC patients. The aim of
      our study therefore was to prospectively examine the efficacy of low-dose atorvastatin on
      indicators of cardiovascular risk such as dyslipidemia and vascular function as well as
      safety in patients with PBC.
    

Detailed description: 
      Primary biliary cirrhosis (PBC) is often associated with abnormalities in serum lipids.
      Hypercholesterolemia is an established risk factor for cardiovascular morbidity and
      mortality. Since many PBC patients have a very slow progression of their underlying liver
      disease cardiovascular risk factors may become more relevant as prognostic facors. Whether
      statins lower serum cholesterol levels and reduce the cardiovascular risk in PBC patients
      remains to be determined. Statins are generally well tolerated and are not associated with an
      increased risk of hepatotoxicity in patients with nonalcoholic fatty liver disease (NAFLD).
      However only limited data on safety on statins in chronic cholestatic liver diseases are
      available. In a recent pilot study at the Medical University of Graz atorvastatin did not
      statistically increase liver enzymes in PBC patients. However, data on long-term treatment
      with atorvastatin in these patients are not yet available. Moreover, long-term treatment with
      statins may have potential beneficial immunomodulatory effects on the disease course of PBC
      in analogy to other immune-mediated disorders such as rheumatoid arthritis and multiple
      sclerosis.
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): oral, 10 mg, daily, 48 weeks
Other intervention name(s): Sortis10 mg, 1-21927, C10AA05
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cholestasis; Atherosclerosis; Statins; Vascular function
Experienced Chinese Herbal Formulas on Pediatric Asthma
Condition: Childhood Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is conducting a randomized, single blind, controlled intervention
      trial to observe the therapeutic effect of experienced chinese herbal formulas based on
      different stages and different symptoms in pediatric asthma.
    

Detailed description: 
      Pediatric bronchial asthma is a common disease that severely threatens physical and mental
      health of children. It's urgent to explore effective ways to alleviate the pain caused by
      asthma.

      In our research, 160 asthmatic children are randomly divided into a Chinese medication group
      (80 cases) and a Western medication control group(80 cases). Patients in the Chinese
      medication group are treated with a series of experienced chinese herbal formulas, whereas
      the western medication control group received a leukotriene receptor antagonist and a
      bronchial relaxant. The Chinese medicine syndromes and western medicine symptoms are scored.
      Pulmonary function and asthma control test score will be applied in this study. We evaluate
      the situation of asthma from different aspects, including index of pulmonary function and
      score of asthma control test. Real-time PCR was used to determine the mRNA expression levels
      of some inflammatory mediators in peripheral.
    

Intervention name(s): experienced chinese herbal formulas; leukotriene receptor antagonist and bronchial relaxant
Intervention type(s): Drug; Drug
Intervention description(s): At the acute stage of asthma :Shegan mixture ; At the remission stage:Huangqi Bushen mixture; 10-30 mL , 2 times a day, for 3 months.; At the acute stage of asthma : etinoline,twice a day for 7 days; At the remission stage: Singulair, once daily for 3 months.
Other intervention name(s): Shegan mixture ,Huangqi Bushen mixture; Singulair,etinoline,
Intervention MeSH terms: Leukotriene Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Traditional Chinese Medicine; Randomized Controlled Trial
Effects of Overnight Low Oxygen Exposure on Energy Balance
Condition: Resting Metabolic Rate; Appetite; Heart Rate Variability
Study type: Interventional

Summary: 
      This research study will evaluate changes in resting metabolic rate, appetite, and heart rate
      variability following overnight exposure (8 h/night) to normobaric hypoxia (NH) or normobaric
      normoxic (NN). In randomized order, participants will sleep one night in NH conditions (~15%
      oxygen; achieved with nitrogen dilution, equivalent to ~8500 feet elevation) and another
      night in NN (control) conditions (~20% oxygen; achieved with nitrogen dilution, equivalent to
      ~1000 feet elevation).
    

Detailed description: 
      Weight loss is a common factor reported in lowlanders traveling to high altitudes. Although
      the exact cause is unknown, studies have shown that weight loss at high altitude is
      associated with the amount of time and severity of the altitude exposure. Upon arrival to
      high altitude (≥ 5000 feet), numerous physiological adaptations occur that may promote weight
      loss, such as increased energy expenditure and reduced appetite. The breadth of current
      altitude research is limited by the logistical and monetary constraints of traveling to
      remote locations or access to an altitude chamber. A more logistically feasible alternative
      is the simulation of low oxygen conditions at sea level, using a commercially available tent
      and generator system to reduce ambient oxygen concentrations. The current research study will
      evaluate changes in resting metabolic rate, appetite, and heart rate variability following
      overnight exposure (8 h/night) to normobaric hypoxia (NH) or normobaric normoxic (NN). In
      randomized order, participants will sleep one night in NH conditions (~15% oxygen; achieved
      with nitrogen dilution, equivalent to ~8500 feet elevation) and another night in NN (control)
      conditions (~20% oxygen; achieved with nitrogen dilution, equivalent to ~1000 feet
      elevation). In the morning, following NH or NN exposure, resting metabolic rate will be
      measured using indirect calorimetry, appetite using an ad libitum buffet meal protocol, and
      heart rate variability by electrocardiogram. It is hypothesized that exposure to overnight NH
      will result in increased resting metabolic rate, decreased appetite, and decreased heart rate
      variability.
    

Intervention name(s): Normobaric Hypoxia; Normobaric Normoxia
Intervention type(s): Device; Device
Intervention description(s): Low oxygen exposure to mimic ~8500 feet elevation.; Normal oxygen exposure to mimic ~1000 feet elevation (sham comparator).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: High altitude; Metabolic adaptations; Energy balance
Association Between Telomere Length and Cardiac Dysfunction
Condition: Cardiac Toxicity; Acute Leukemia; Childhood Cancer
MeSH terms: Cardiotoxicity
Study type: Observational

Summary: 
      Compelling epidemiological evidence indicates that alterations of relative telomere length
      (RTL) are associated with cardiac dysfunction caused by chemotherapy in children with acute
      leukemia (AL).The aim of this study was to explore association between RTL content in
      peripheral blood cells could be used as a risk predictor for severity of cardiac damage.
    


Intervention name(s): Relative telomere length
Intervention type(s): Diagnostic Test
Intervention description(s): Relative telomere length in peripheral blood cell
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 300 eligible acute leukemia patients were anticipated to include in this study.
      
Biospecimen description: 
      Relative telomere length in peripheral blood cell
A Study to Evaluate Safety, Tolerability, and Immunogenicity of Heterologous Prime-boost Regimens Using the Multivalent Filovirus Vaccines Ad26.Filo and MVA-BN-Filo Administered in Different Sequences and Schedules in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety and immunogenicity of MVA-BN-Filo and
      Ad26.Filo as heterologous prime-boost vaccine regimens in healthy adult participants.
    


Intervention name(s): Ad26.Filo; MVA-BN-Filo; Ad26.ZEBOV; Placebo; MVA-BN-Filo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Ad26.Filo intramuscular (IM) injection at a dose of 9*10^10 viral particles (vp).; MVA-BN-Filo intramuscular (IM) injection at a dose of 5*10^8 infectious units (Inf U).; Ad26.ZEBOV intramuscular (IM) injection at a dose of 5*10^10 vp.; IM injection of 0.9 percent saline.; MVA-BN-Filo intramuscular (IM) injection at a dose of 1*10^8 Inf U.
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Buprenorphine Maintenance for Opioid Addicts - 1
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in
      treatment of opiate and cocaine dependence.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
Keywords: Opioid-Related Disorders
Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma
Condition: Glioblastoma or Malignant Glioma
MeSH terms: Glioblastoma; Glioma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and
      Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with
      Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant
      III (EGFRvIII).

      This is a first in human (FIH), open-label, sequential-dose-escalation study in subjects with
      EGFRvIII-positive glioblastoma or malignant glioma. This study will enroll 2 groups of
      subjects according to disease stage, recurrent disease (Group 1) and maintenance treatment
      after SoC in newly diagnosed disease (Group 2).
    


Intervention name(s): AMG 596; AMG 404
Intervention type(s): Drug; Drug
Intervention description(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Bayesian logistic regression model
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase 1/1b; EGFRvIII-positive glioblastoma or malignant glioma; safety and tolerability; AMG 596