bioihbjkbjnl/mcl2 huggingface dataset:
Histopathology Following CCH Injection
Condition: Characteristics of Subcutaneous Tissue
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the histopathology of subcutaneous tissue isolated after single or multiple
      Collagenase Clostridium Histolyticum (CCH) injection techniques in adult female participants
      undergoing abdominoplasty.
    


Intervention name(s): Collagenase Clostridium Histolyticum Single Injection Technique; Collagenase Clostridium Histolyticum Multiple Injection Technique
Intervention type(s): Drug; Drug
Intervention description(s): CCH was injected subcutaneously using a single injection technique. Dose per each administration was 0.07 mg.; CCH was injected subcutaneously using a multiple injection technique. Dose per each administration was 0.0653 mg.
Other intervention name(s): EN3835; CCH; EN3835; CCH
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Investigational Plan: Evaluation of the Performance of the Motus Cleansing System
Condition: CRC
Study type: Interventional

Summary: 
      The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a
      poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.
    

Detailed description: 
      The main objective of the study is to evaluate the performance of the Motus cleansing system
      used in conjunction with screening, diagnostic or surveillance colonoscopy
    

Intervention name(s): Motus Cleansing System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Effects of Zero-Time Exercise (ZTEx) on Inactive Adults With Insomnia
Condition: Insomnia, Primary
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Objectives: To evaluate the clinical effects of Zero-Time Exercise (ZTEx) for treating
      insomnia disorder delivered by a training course.

      Hypothesis: Subjects in the ZTEx training group will have greater improvement in insomnia
      symptoms and daytime impairment than those in the sleep hygiene education (SHE) group at week
      8.

      Design and subjects: A randomized controlled trial. 32 inactive subjects with insomnia
      disorder recruited from the community will be randomized to ZTEx training or SHE groups in a
      1: 1 ratio.

      Study instrument: Insomnia Severity Index (ISI) will be used to assess insomnia symptoms and
      daytime impairment.

      Interventions: Subjects in the ZTEx training group will attend two training lessons (2-hour
      each) to learn ZTEx and practice it every night for 8 weeks; subjects in the SHE group will
      receive sleep hygiene education with the schedule and duration that are same to the ZTEx
      training group.

      Main outcome measures: The primary outcome measure is the ISI score. Other measures include
      sleep parameters by subjective sleep diary and objective actigraphy, Hospital Anxiety and
      Depression Scale, Multidimensional Fatigue Inventory-20 and Short Form-6 Dimension.
      Acceptability and compliance of ZTEx will be evaluated.

      Data Analysis: Differences in the questionnaire scores, subjective and objective sleep
      parameters will be examined using a mixed-effects model.
    


Intervention name(s): Zero Time Exercise; Sleep hygiene education
Intervention type(s): Other; Other
Intervention description(s): Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.; We offer a 2-session education course to teach the subjects about sleep hygiene practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: insomnia
Assessment of the Effect of Food on ABT-143 Bioavailability
Condition: Pharmacokinetic Variables
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-dose, open-label, two-period crossover study of ABT-143
    


Intervention name(s): ABT-143 ( rosuvastatin calcium and fenofibric acid ); ABT-143 (rosuvastatin calcium and fenofibric acid )
Intervention type(s): Drug; Drug
Intervention description(s): one dose under low-fat meal condition; one dose under fasting meal condition
Other intervention name(s): ABT-143; fenofibric acid/rosuvastatin calcium
Intervention MeSH terms: Calcium, Dietary; Rosuvastatin Calcium; Fenofibric acid; Fenofibrate; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Food effect, phase I; adverse events
Fluid Balance in Children Undergoing Fontan Surgery
Condition: Heart Defects, Congenital; Hypoplastic Left Heart Syndrome
MeSH terms: Heart Defects, Congenital; Hypoplastic Left Heart Syndrome; Congenital Abnormalities
Study type: Observational

Summary: 
      This project will evaluate fluid balance and edema formation in children with congenital
      heart disease in need of a surgical procedure, The Fontan procedure. Surgery will make the
      child end up with a univentricular heart with one-chamber circulation ( Fontan circulation).
      This project will evaluate if these children has increased micro vascular leakage before
      surgery due to their congenital heart defect. The project will also investigate if the edema
      formation seen during cardiac surgery with the use of Cardio-Pulmonary Bypass (CPB) and
      hypothermia is caused by capillary leakage of plasma protein.

      The study hypothesis are

        1. Edema developed during heart surgery is caused by reduced colloid osmotic pressure
           gradient through the capillary membrane.

        2. The degree of micro vascular leakage in open-heart surgery is related to duration of CPB
           and hypothermia.

        3. Fontan circulation cause peripheral edema related to elevated central venous pressure
           and is not caused by increased micro vascular leakage of plasma proteins.
    


Intervention name(s): Pre BCPC; Pre TCPC; BCPC surgery; TCPC
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection; Routine catheterization before surgical procedure Total CavoPulmonary Connection; Surgical procedure Bidirectional CavoPulmonary Connection; Surgical procedure Total CavoPulmonary Connection
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with congenital heart defect scheduled for Fontan surgery
      
Biospecimen description: 
      Interstitial fluid Serum
A Study of JNJ-68179280 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of JNJ-68179280 compared
      with placebo after administration of single ascending oral doses of JNJ-68179280 administered
      to healthy participants (Part 1), multiple ascending oral doses of JNJ-68179280, administered
      to healthy participants once daily (Cohorts 1 through 4) or twice daily (Cohort 5) over 14
      consecutive days (Part 2) and multiple ascending oral doses of an alternative JNJ-68179280
      formulation, administered to healthy participants once daily over 14 consecutive days (Part 3
      if conducted).
    


Intervention name(s): JNJ-68179280; Placebo
Intervention type(s): Drug; Other
Intervention description(s): JNJ-68179280 will be administered as an oral capsule.; Matching placebo will be administered as an oral capsule.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR)
Condition: Rhinitis, Allergic, Perennial and Seasonal; Rhinitis, Allergic
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      This Phase IV interventional study is a multi-center, randomized, double-blind,
      placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55
      mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages
      2 to 12 years with AR.

      This study comprises screening and run-in period (4 to14 days), double-blind treatment period
      (28 days) and follows up period (3 to7 days). Subjects entering the study will participate
      for maximum of 50 days, including five clinical visits and a follow-up contact.

      The study is planned to enroll approximately 360 subjects.
    


Intervention name(s): FFNS; Placebo
Intervention type(s): Drug; Other
Intervention description(s): FF as a aqueous suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose administered via a metered side-actuated nasal spray device.; Placebo as a aqueous suspension to match the other study treatments minus the active component(s) for intranasal inhalation administered via a metered side-actuated nasal spray device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Seasonal; Fluticasone Furoate; Perennial; Allergic Rhinitis; Nasal Spray
Study of Metanx® in Subjects With Type 2 Diabetic Peripheral Neuropathy (DPN)
Condition: Type 2 Diabetic Peripheral Neuropathy (DPN)
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to determine if Metanx improves sensory neuropathy in
      persons with Type 2 diabetes. Metanx is a medical food available with a prescription from a
      physician. It consists of L-methylfolate, Pyridoxal 5'-phosphate, and Methylcobalamin, which
      are the active forms of folate, vitamin B6, and vitamin B12, respectively. Subjects will be
      randomly assigned to receive either Metanx or placebo for 6 months.
    


Intervention name(s): Metanx (a medical food); Metanx placebo
Intervention type(s): Other; Other
Intervention description(s): Metanx one tablet twice a day; Metanx placebo one tablet twice a day
Intervention MeSH terms: Vitamin B 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metanx; diabetes; neuropathy; folic acid; folate; L-methylfolate; vitamin B6; Pyridoxal 5'-phosphate; vitamin B12; methylcobalamin
Study to Evaluate the Potential of Air Structuring Protein to Elicit Allergic Reactions in Mold Sensitized People
Condition: Allergy to Mold
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      Air Structuring Protein (ASP) is a small protein derived from a fungus which is already
      widely used to produce enzymes that are added to foods. ASP has the possibility of
      stabilising the air phase of ice-cream and therefore there is interest in ASP as a potential
      ice-cream ingredient.

      Toxicological tests have also been carried out to further confirm the safety of the material
      and no evidence of genotoxicity or acute toxicity has been observed in any of the tests.

      As part of the safety evaluation of a new protein for use in foods, the potential
      allergenicity is also investigated and Unilever is sponsoring a study to evaluate this aspect
      of ASP. This study will investigate:

        -  Whether ASP has the potential to elicit a positive skin prick test (SPT) in a population
           of participants with proven sensitivity to mould.

        -  Whether ASP is responsible for any positive SPT reactions, should they occur.

        -  And if any positive SPT reactions to ASP occur, whether such reactions are clinically
           relevant with respect to food allergy.

      The study is divided in three stages. In Stage 1 and Stage 2, the SPT is "open label," which
      means that both the participant and the study doctor will know which materials are being
      tested.

      In Stage 3, the food challenge has a "crossover" design, meaning that participants will take
      one of the products (ASP or placebo [food containing no ASP]) during the first half of the
      study and the other treatment during the second half. The order of ASP and placebo will be
      decided randomly, like tossing a coin. To make the comparison between ASP and placebo as fair
      as possible, the food challenge is "double blinded." This means that neither the participant
      nor the study doctor will know which kind of products (ASP or placebo) the participant is
      taking.

      This is a multi centre study which is taking place in the UK.
    


Intervention name(s): Air Structuring Protein; Placebo sorbet
Intervention type(s): Other; Other
Intervention description(s): A novel food protein preparation; Placebo sorbet for double blind placebo controlled food challenge
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Mold sensitized
Burst Spinal Cord Stimulation for Neuropathic Pain
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional

Summary: 
      Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo
      controlled pilot study burst stimulation seemed superior to tonic stimulation over a period
      extending more than 2 years, and even though an incidental finding, this design seemed
      capable of suppressing pain without mandatory induction of paresthesias. This permits for the
      first time to scientifically prove that spinal cord stimulation is better than placebo
      stimulation. A study was therefore initiated to find out whether spinal cord stimulation is
      indeed capable of suppressing neuropathic limb pain in a placebo controlled way.
    

Detailed description: 
      Patients receive three type of stimulation (burst, tonic and sham). We want to compare these
      different stimulation protocol to verify which one is the one the patient prefer the most and
      have the least side-effects (paresthesia)
    

Intervention name(s): dorsal column stimulator
Intervention type(s): Procedure
Intervention description(s): test different settings of stimulation
Other intervention name(s): IPG is used by ST Jude medical together with an 88 lamitrode lead
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tonic, burst and placebo stimulation
Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants
Condition: Acute Diarrhea; Acute Gastroenteritis
MeSH terms: Gastroenteritis; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of zinc in acute watery diarrhea in
      children. The investigators will evaluate the effect of product versus placebo.
    

Detailed description: 
      Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood,
      today exist strong evidence of beneficial effect of use of zinc in acute diarrhea in children
      over 6 months. but there are not enough clinical trials to show this beneficial effect on
      children under 6 months.

      Objectives: To evaluate the effect of zinc in the treatment of children under 6 months age
      with acute diarrhea.

      Methods: A randomized clinical trial, controlled, double-blind. The investigators will have
      two groups of patients : One group will receive zinc plus oral rehydration and the other one
      will receive placebo plus oral rehydration; the parameters of evaluation are going to be the
      duration of diarrheal episode, number of diarrhea stools by day, weight of stool, nutritional
      state.
    

Intervention name(s): Zinc Sulfate; placebo
Intervention type(s): Drug; Other
Intervention description(s): zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.; cornstarch powder diluted in distilled water, dosage 2.5 ml per day
Other intervention name(s): Suplizinc
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Diarrhea; Zinc; Children
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Multiple
      Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in
      Adult Healthy Volunteers and Subjects with MCI or Early AD. In addition, an exploratory study
      of the effect of a high fat meal was conducted.
    


Intervention name(s): NTRX-07; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Investigational orally administered CB2 agonist; Matched placebo administered orally
Other intervention name(s): MDA7
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CB2
Effects of Exercise Training in Patients With Permanent Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 1

Summary: 
      Atrial fibrillation (AF) is a common arrhythmia. The proposed patholophysiological mechanisms
      of AF include abnormal electrical conduction in atrium and sympathovagal imbalance with
      increased vagal tone. Patients with AF have poor exercise capacity that may contribute to
      decreased atrial effective refractory period, and decreased cardiac output and heart rate
      reserve, and may result in poor quality of life. Poor endothelial function had been noted in
      patients with AF, associated with increased risks of cerebrovascular and cardiovascular
      disease. Exercise training has been noted to improve exercise capacity and quality of life in
      patients with AF only in some studies. Endothelial function can be improved by exercise
      training in patients with cardiovascular disease, but no report in patients with AF. Evidence
      of exercise training is still needed in patients with AF. The purpose of this study is to
      investigate the effect of exercise training on

        1. endothelial function

        2. heart rate variability

        3. exercise capacity

        4. quality of life.
    

Detailed description: 
      A randomized controlled study was implemented to examine :(1) the effect of interval aerobic
      exercise training combined with resistance training on endothelial function, heart rate
      variability (HRV), exercise capacity, and quality of life (QoL); (2) the influential factors
      related to exercise capacity, and the relationship between exercise capacity and quality of
      life in patients with permanent atrial fibrillation (AF).
    

Intervention name(s): Exercise training
Intervention type(s): Other
Intervention description(s): Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
Other intervention name(s): Aerobic exercise Training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atrial Fibrillation; Exercise Training; Endothelial Function; Autonomic Nerve Modulation; Exercise Capacity; Quality of Life
Effect of BIIL 284 BS on Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to investigate the effect of 14-day treatment with BIIL 284 BS on sputum neutrophils
      and specific inflammatory markers in patients with clinically well-defined moderate chronic
      obstructive pulmonary disease (COPD)
    


Intervention name(s): BIIL 284 BS; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Buprenorphine Maintenance Dose Schedule and Treatment Setting - 1
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess optimal dosage of buprenorphine on a thrice weekly
      schedule in a pilot clinical trial.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention description(s): Experimental Maintenance treatment with daily medication
Experimental Maintenance treatment with thrice-weekly medication
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid dependence
CD19/CD20 Dual-CAR-T in B-cell Leukemia Patients
Condition: B-cell Leukemia
MeSH terms: Leukemia; Leukemia, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, single arm, open-label, phase I study to evaluate the safety and
      efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell
      leukemia.
    

Detailed description: 
      This Phase I study is designed as a pilot trial evaluating the safety and efficacy of
      CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B cell leukemia.
      Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on
      days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells. Safety and efficacy of
      CD19/CD20 Dual-CAR-T cells therapy will be monitored. The purpose of current study is to
      determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients
      with refractory and relapsed B-cell leukemia.
    

Intervention name(s): CD19/CD20 Dual-CAR-T cells
Intervention type(s): Biological
Intervention description(s): CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 0.6-3×106 cells/kg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment