bioihbjkbjnl/mcl2 huggingface dataset:
PillCam SBC System Functionality in Established and Suspected IBD Patients
Condition: Chronic Inflammatory Small Bowel Disease; Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      This clinical study is designed to evaluate the PillCam SBC system performance in 50
      established or suspected inflammatory bowel disease (IBD) patients by visualizing and
      assessing their small and large bowel.
    

Detailed description: 
      The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data
      recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the
      SBC capsule are panoramic field of view and adaptive frame rate customized for complete
      coverage of both small bowel and colonic mucosa.

      Fifty established and suspected IBD patients (at least half of them with established crohn
      disease (CD)) with active or quiescent disease activity, aged 18 years and up, with no
      symptomatic stricture or known obstruction that would prevent capsule passage will be
      enrolled in up to 6 medical sites in Israel and Europe.

      Patients will undergo bowel prep, followed by a PillCam SBC capsule examination. Patency
      capsule may precede PillCam SBC ingestion according to physician discretion.

      The PillCam Software videos will be evaluated by local site reader following a Subjective
      Assessment Form fulfillment.
    

Intervention name(s): PillCam SBC system
Intervention type(s): Device
Intervention description(s): The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa.
Other intervention name(s): PillCam Endoscopy system
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Cognitive Assessment Battery (CAB) Beta Study
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Observational

Summary: 
      The overall objective of this study is to identify a 60 minute cognitive battery, for
      subsequent use in clinical trials, that detects cognitive deficits in early HD and late
      pre-manifest HD compared to controls, and that has a potential to show drug induced
      improvements.
    

Detailed description: 
      Huntington's disease (HD) is an autosomal dominant genetic disease which typically manifests
      beginning in adulthood in the form of movement symptoms, cognitive decline, and psychiatric
      changes. The proposed research is undertaken in collaboration with CHDI Foundation, Inc., a
      not for profit organization dedicated to finding treatments for HD. CHDI's goal is to develop
      or help to develop both symptomatic and disease modifying treatments for HD. To enable future
      therapeutic trials, CHDI has sponsored several prospective, longitudinal, observational
      biomarker studies of pre-manifest and early HD with the goal of determining which combination
      of measures is the most sensitive for detecting changes over the natural progression of
      pre-manifest and early HD. These and other studies have demonstrated a progressive decline in
      cognitive function in patients with the huntingtin gene mutation beginning in the
      pre-manifest period and progressing throughout the course of the disease. These findings
      support the use of cognitive measures as endpoints in future therapeutic clinical trials.
      CHDI is committed to the development of a cognitive assessment battery for use in HD
      therapeutic trials.

      There will be paper and pencil and computerized cognitive tests given over a six week period
      to non-HD control subjects, pre-manifest HD and early manifest HD subjects.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study participants will be pre-HD, early stage HD and control subjects. The cognitive tests
        will be given to all participants. (only varied by order of administration) in order to
        determine what measures will be best at detecting cognitive changes associated with HD.
      
Keywords: Huntington's Disease; Cognitive Battery; Cognitive Testing; Cognition; pre-manifest Huntington's Disease
Diagnosis of Acute Appendicitis: Low-dose Computed Tomography (CT) Versus Standard-dose CT
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether low-dose CT is not inferior to
      standard-dose CT in the rate of unnecessary appendectomy.
    

Detailed description: 
      Acute appendicitis is a very common disease with the lifetime incidence of 7%. Abdomen CT is
      an established first-line diagnostic test in patients suspected of having acute appendicitis.
      Since many individuals suspected of having acute appendicitis are young, with a mean age of
      30 years, CT radiation is of particular concern.

      The estimated lifetime attributable risk of death from cancer due to the radiation exposure
      of a single abdomen CT study is 2-7/10,000 for average adults ranging 20-40 years in age.

      The purpose of this study is to determine whether low-dose CT is not inferior to
      standard-dose CT in the negative appendectomy rate.
    

Intervention name(s): Diagnostic CT; Diagnostic CT
Intervention type(s): Radiation; Radiation
Intervention description(s): 2 mSv in an average patient (Low-dose (1/4 to 1/5 of standard-dose)); 8 mSv in an average patient (Standard-dose CT)
Other intervention name(s): low-dose CT; standard-dose CT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of ABY-035
Condition: Psoriasis; Healthy Subjects
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first-in-human study is to investigate the safety and tolerability of
      ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to
      psoriasis patients.
    

Detailed description: 
      This first in human study with ABY-035 (a novel IL-17A inhibitor (interleukin 17A)) consists
      of four Parts. Part A consists of a single ascending intravenous dose study with 40 healthy
      volunteers divided into five dose cohorts. Each group consists of 8 subjects where 6 subjects
      will receive ABY-035 and 2 will receive placebo. The subjects will be followed for
      pharmacokinetic and safety assessments up to Day 95 after dosing.

      Part B of the study consists of 6 healthy volunteers who will be given a single subcutaneous
      dose of ABY-035. The subjects will follow the same study visit schedule as Part A.

      Part C of the study will include up to 12 moderate-to-severe psoriasis patients who each
      patient will be given a single intravenous dose of ABY-035. The patients will follow the same
      study visit schedule as Part A and B.

      Part D of the study will include up to 18 psoriasis patients (mild, moderate or severe). Each
      patient will participate in 3 or 7 biweekly dosing occasions of subcutaneously administered
      ABY-035. Patients will be followed regularly for safety, efficacy and pharmacokinetics for 8
      weeks post-final dose.
    

Intervention name(s): Placebo; ABY-035 i.v.; ABY-035 s.c.
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose i.v.; Single dose i.v.; Single dose s.c.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Trial Comparing Treatment of Relapsing-Remitting Multiple Sclerosis (RR-MS) With Two Doses of Glatiramer Acetate (GA).
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Teva is developing a 40 mg/ml GA Injection, administered once daily under the skin, for the
      treatment of R-R MS. The study drug is a higher dose formulation of Copaxone® (20 mg/ml GA),
      a marketed medication, approved for the treatment of R-R MS. GA is an immunomodulating drug
      that has anti inflammatory and neuroprotective properties. The study treatment duration is 12
      months.
    


Intervention name(s): Glatiramer Acetate (GA) 40 mg; glatiramer acetate 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): Glatiramer Acetate Injection 40 mg/ml Daily subcutaneous injection for 12 months; Glatiramer Acetate Injection 20 mg/ml Daily subcutaneous injection for 12 months
Other intervention name(s): Copaxone®; Copaxone®
Intervention MeSH terms: Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Use of McGrath Videolaryngoscope to Assist Transesophageal Echocardiography Probe Insertion in Intubated Patients
Condition: Other Complications of Surgical and Medical Procedures
Study type: Interventional

Summary: 
      The primary aim of this study is to investigate the difference in the first attempt and
      overall success rate of different techniques for insertion of transesophageal
      echocardiography. Secondary aim is to investigate the difference of the duration of insertion
      using the selected technique, complications during insertion such as oropharyngeal mucosal
      injury and hematoma.
    

Detailed description: 
      Eighty adult patients, who received general anaesthesia for elective open heart surgeries
      that required transesophageal echocardiography insertion, will be randomized by means of a
      computer-generated randomization order into two groups: Conventional group (Group C), and
      videolaryngoscope group (group VL).

      Success rate of the selected technique (first attempt and overall), duration of insertion for
      selected technique, complications such as oropharyngeal mucosal injury and hematoma will be
      noted.
    

Intervention name(s): conventional technique; videolaryngoscope technique
Intervention type(s): Device; Device
Intervention description(s): transesophageal echocardiography probe was inserted using a traditional blind insertion technique.; transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: transesophageal echocardiography; videolaryngoscope; oropharyngeal injury
Nutritional Aspects of Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional

Summary: 
      OBJECTIVES: I. Determine dietary macronutrient intake in children with Rett syndrome and in
      healthy controls.

      II. Measure sleeping and awake metabolic rates in various positions, i.e., reclining,
      sitting, and standing, by whole-room indirect calorimetry and isotope dilution.

      III. Quantify activity patterns by time-motion studies using 24-hour activity records and
      12-hour videotaping.

      IV. Correlate 24-hour activity patterns with 24-hour heart rate telemetry and short-term
      oxygen consumption.

      V. Estimate 24-hour fecal and urinary energy losses. VI. Determine body composition by
      clinical anthropometry, whole-body potassium counting, and total-body electrical conductance.

      VII. Calculate apparent energy needs based on measurement of energy intake and expenditure.
    

Detailed description: 
      PROTOCOL OUTLINE:

      All participants undergo extensive nutritional and metabolic assessment with body composition
      evaluation. Studies include macronutrient intake, body fat, lean muscle mass, metabolic rate,
      and time-action studies; and 24-hour cardiac telemetry. Rett syndrome girls also receive a
      hemogram and hand x-ray.
    

Intervention name(s): Metabolic assessment with body composition evaluation
Intervention type(s): Procedure
Primary purpose: Diagnostic
Keywords: Rett syndrome; neurologic and psychiatric disorders; rare disease
Bioequivalence Study of Montelukast Sodium Chewable Tablets 4mg and 5mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Montelukast sodium chewable tablets 4mg and 5mg of
      Dr. Reddy's Laboratories Limited, India comparing with that of SINGULAIR® (containing
      Montelukast sodium) chewable tablets 4mg and 5 mg of Merck Sharp & Dohme Ltd., USA in
      healthy, adult, human subjects under fasting conditions.
    

Intervention name(s): Montelukast sodium chewable tablets 4 mg and 5 mg
Intervention type(s): Drug
Intervention description(s): Montelukast sodium chewable tablets 4mg and 5mg
Other intervention name(s): SINGTJLAIR ®
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Montelukast Sodium; crossover
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABBV-257 in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose study designed
      to assess the safety, tolerability, pharmacokinetics, and immunogenicity of different dose
      levels of ABBV-257 given with methotrexate. ABBV-257 or placebo will be administered once
      every other week (EOW) for a total of 4 doses. Subjects will continue on their stable dose of
      methotrexate weekly throughout participation in the study.

      This study will be conducted in approximately 24 subjects in 3 dose groups, with 8 subjects
      per group. Within each group, 6 subjects will be randomized to receive ABBV-257 and 2
      subjects will receive placebo. Subjects participating in one dose group will be ineligible to
      participate in another dose group in the study.
    

Detailed description: 
      Multiple dose study designed to assess the safety, tolerability, pharmacokinetics, and
      immunogenicity of different dose levels of ABBV-257 given with methotrexate.
    

Intervention name(s): ABBV-257; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): subcutaneous injection; Placebo for ABBV-257
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Rheumatoid Arthritis
Prognostic Value of Body Composition in Lung Cancer
Condition: Body Composition and Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      The effect of body composition on the survival rate is one of the research topics of interest
      in cancer patients and gaining attention in the last years. Body mass index is often used a
      proxy measure of total adiposity and previous studies examining the relationship between BMI
      and cancer outcomes have been showed distinct results . Obese patients with malignancies such
      as colorectal, breast, and pancreatic cancers, have been shown to have a worse prognosis than
      normal-weight patients . Nevertheless, obese patients with non small cell lung cancer(NSCLC)
      have been observed to have a better clinical outcome than normal/low-weight cancer patients .
      In this study, we examined the effects of subcutaneous adipose tissue, visceral adipose
      tissue and skeletal muscle volumes on survival in metastatic NSCLC patients under different
      treatment regimens. Since there is no standard method for adipose tissue measurement, we
      evaluated the abdominal cavity with multi-slice and single-slice computed tomography
      measurements.
    


Intervention name(s): measured of body composition with computed tomography
Intervention type(s): Other
Intervention description(s): Multislice and single-slice computed tomography images were used for assessment of body composition including visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), skeletal muscle mass volume (SMMV)
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Eighty-three patients with stage-IV NSCLC who received at least one cycle of platinum based
        chemotherapy (PBCT) or tyrosine kinase inhibitor (TKI) therapy and who underwent pre
        treatment FDG PET/CT from June 2012 to February 2019
Multi Strain Probiotic Preparation in Patients With Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome With Diarrhea; Effects of Probiotics
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal
      disorders characterized by recurrent abdominal pain associated with defecation or a change in
      bowel habits without any structural abnormalities. Despite extensive research, the
      pathogenesis of IBS has not been clearly elucidated yet. Recent studies have shown that
      disturbed gut microbiota may promote the development and maintenance of IBS. Significant
      changes in the microbial communities of healthy controls vs IBS patients have been reported
      in several studies. These findings promoted the research on probiotics for the treatment of
      IBS. Probiotics are live microorganisms which, when administered at the right dose, have a
      positive effect on human health. The currently published systemic reviews and meta-analyses
      of randomized clinical trials have indicated that probiotics have beneficial clinical effects
      and can help to reduce global and specific IBS symptoms significantly. However, the effect
      depends on the specific composition of the probiotic preparation, and some meta-analyzes
      indicate that multi-strain preparations are more effective than single-strain preparations.
      Therefore, further research is highly anticipated. The purpose of the current clinical trial
      is to assess the effectiveness of multi-strain probiotic preparation in patients with
      diarrhea predominant IBS (IBS-D).
    


Intervention name(s): Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral supplementation with multi-strain probiotic preparation; Maltodextrin as placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase I/II to Assess Safety, Tolerability and Efficacy of DL-lactic Acid Syrup in Children With Recurrent Tonsillitis
Condition: Recurrent Tonsillitis in Children
MeSH terms: Tonsillitis; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study objectives are to evaluate Tonsitin™ (10% Lactic Acid) safety, tolerability and
      preliminary efficacy, as a potent treatment for Recurrent Tonsillitis in children.
    


Intervention name(s): DL - Lactic Acid; Raspberry flavored syrup
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored); Placebo group to receive Raspberry flavored Syrup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Recurrent Tonsillitis; Streptococcus A
Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children
Condition: Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a multicenter, randomized, open-label, parallel controlled phase III study, compared
      pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration
      formulation).

      All the subjects were randomized into two groups, test group (PEG somatorpin) and control
      group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled
      in control group. Considering the case loss during the clinical study, 20% of the patients
      were added in each of the group, that is 240 children were in test group and 120 children
      were in control group, totally 360 children were enrolled in the phase III clinical study.

      Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point
      of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time
      point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the
      evaluation would be made when the treatment is finished.
    


Intervention name(s): PEG-somatropin
Intervention type(s): Biological
Intervention description(s): drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 months
Other intervention name(s): recombinant human growth hormone; peglyated growth hormone; PEG-GH
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pegylated somatropin; PEG-rhGH; growth hormone; Growth Hormone Deficiency; phase III study
Vilazodone for the Treatment of Posttraumatic Stress Disorder
Condition: PTSD; Depression
MeSH terms: Depression; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether vilazodone is effective in the treatmen of
      Posttraumatic Stress Disorder (PTSD)and co-morbid mild or more depression.
    


Intervention name(s): Treatment (Viibryd)
Intervention type(s): Drug
Other intervention name(s): Vilazodone
Intervention MeSH terms: Vilazodone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vilazodone; PTSD; Depression