bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Integrated Telerehabilitation of COPD Patients. A Multi-Center Trial
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      This research project aims to conduct a three-arm multi-center randomized controlled trial
      (RCT) on an innovative telerehabilitation intervention for patients with chronic obstructive
      pulmonary disease (COPD). The overall purpose of the RCT is to demonstrate whether long-term
      integrated telerehabilitation involving exercise training at home, telemonitoring, and
      education/self-management will prevent hospital readmissions, thus reducing healthcare costs,
      for patients with COPD, and will improve patient status and quality of life.
    


Intervention name(s): Exercise training at home; Telemonitoring and education/self-management
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Exercise; Rehabilitation; Telemedicine; Treatment Outcome; Costs and Cost Analysis; Physical Therapists; Adaptation, Psychological
Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults
Condition: Smallpox; Poxvirus Infection
MeSH terms: Smallpox; Poxviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To estimate the smallpox vaccination take rate in healthy young adults not previously
      vaccinated with a smallpox vaccine.

      Secondary Objectives:

      To describe antibody response to vaccination and evaluate the take for each subject at
      various timepoints for each batch and pooled batches and to evaluate local signs, symptoms,
      and overall safety in healthy young adults not previously vaccinated with a smallpox vaccine.
    


Intervention name(s): Smallpox vaccine, LISTER strain, from chick embryo cells
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Smallpox; Orthopoxvirus; Poxvirus; Vaccina Virus; LISTER Strain; Bioterrorism
A Study of MDL 28,574A in HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the safety profile of MDL 28574A following both acute and subchronic dosing
      in HIV-positive patients. To determine the MTD of both acute and subchronic doses of this
      drug when administered as oral solution. To determine the pharmacokinetic profile of MDL
      28574A and castanospermine (from which MDL 28574A is derived) following both acute and
      subchronic dosing.
    

Detailed description: 
      In Part A of the study, patients receive a single oral dose of MDL 28574A on day 1 and are
      followed through day 7. In Part B, patients receive single daily doses of the drug on days 1
      through 14 and are followed through day 21.
    

Intervention name(s): Celgosivir hydrochloride
Intervention type(s): Drug
Masking: Double
Primary purpose: Treatment
Keywords: MDL 28574
Escalating Dose Study in Healthy Volunteers With SEN0014196
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a trial in healthy volunteers to study the safety, tolerability and pharmacokinetics
      of single and multiple escalating doses of SEN0014196.
    


Intervention name(s): SEN0014196; SEN0014196; SEN0014196; SEN0014196; SEN0014196; SEN0014196; SEN0014196; SEN0014196; SEN0014196; SEN0014196; SEN0014196
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg single oral dose; 25 mg single oral dose; 75 mg single oral dose; 150 mg single oral dose; 300 mg single oral dose; 600 mg single oral dose; 300 mg single oral dose (females); 100 mg multiple oral dose; 300 mg multiple oral dose; 100 mg BID multiple oral dose; 100 mg BID multiple oral dose (females)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX
Condition: Encephalitis
MeSH terms: Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was undertaken to assess the immunogenicity and safety of a booster dose of a live
      attenuated chimeric Japanese Encephalitis vaccine (JE-CV) after primary vaccination with
      SA14-14-2 in Thai children aged 1 to <5 years. In addition, to assess the impact of the
      duration interval after primary vaccination on subsequent booster response.
    

Detailed description: 
      The subject will receive one booster dose of IMOJEV with hepatitis A vaccine (inactivated
      vaccine of GlaxoSmithKline) as concomitant vaccine. Blood samples will be collected to assess
      for Japanese Encephalitis Neutralizing Antibody at baseline (pre-vaccination) and 4 week post
      -vaccination.
    

Intervention name(s): Live attenuated chimeric Japanese Encephalitis vaccine; Inactivated Hepatitis A vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh; 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
Other intervention name(s): Imojev; Havrix
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Live attenuated Japanese Encephalitis vaccine; IMOJEV; CD.JEVAX; Booster; Thai children; Immunogenicity; Safety; Interchangeability; Hepatitis A vaccine; Vaccination or Other Immunization Procedure
Education of Parents About Discipline in a Way That is Culturally Sensitive
Condition: Violence; Parenting
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      To determine if a brief primary care intervention can educate under-resourced and minority
      parents about discipline in a way that is culturally sensitive.
    


Intervention name(s): Play Nicely
Intervention type(s): Behavioral
Intervention description(s): Play Nicely is a multimedia program that teaches parents about appropriate methods to discipline.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Impact of Naloxone on the Analgesic Effect of Paracetamol in Healthy Volunteers
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to check if Naloxone induce an inhibiting effect on the analgesic
      effect of paracetamol in healthy volunteer, using evoked potentials.
    

Detailed description: 
      Double Blind, cross-over study in healthy volunteers.
    

Intervention name(s): Naloxone and paracetamol
Intervention type(s): Drug
Intervention description(s): to check if naloxone induce an inhibiting effect on the analgesic effect of paracetamol in healthy volunteer, using evoked potentials
Intervention MeSH terms: Acetaminophen; Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain,; sensitization,; analgesia
Intracranial Hydatid Cyst
Condition: Intracranial Neoplasm
MeSH terms: Echinococcosis; Brain Neoplasms
Study type: Interventional

Summary: 
      Central nervous system (CNS) hydatid cysts is a rare presentation of hydatid cyst, although
      may be the cause of intracranial space-occupying lesions in 4% in endemic countries. It
      affects mostly children. The diagnosis of CNS hydatid is still problematic in spite of the
      advancements in imaging techniques (CT or MRI). Extirpation of the intact cyst is the
      treatment of choice, resulting in most cases to a complete recovery.
    

Detailed description: 
      Hydatid disease is a parasitic induced disease caused by either Echinococcus granulosus or
      Echinococcus multilocularis during the larval stage of these tapeworms. Hydatid cysts are
      endemic in many countries, such as Latin America (Argentina, Brazil, Chile, Peru, and
      Uruguay); followed by Europe (France, Italy, and Greece), the Middle East (Turkey, Lebanon,
      Syria, and Jordan), Southeast Asia (China, Iran, and India) and Africa (Tunisia and less
      commonly, Egypt)
    

Intervention name(s): cyst extirpation
Intervention type(s): Procedure
Intervention description(s): complete removal of the cyst without rupture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Exercise Training on the Function of the High Density Lipoprotein (HDL)-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Metabolic Syndrome(HERMET-Study)
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of the present study is to characterize the quality of HDL-Cholesterol in
      patients with metabolic syndrome and reduced blood HDL-Cholesterol levels and to examine the
      effect of exercise training on the vasculoprotective effects of HDL-Cholesterol in these
      patients. Additionally the investigators aim to investigate the endothelial function,
      oxidative stress and the regenerative capacity of the endothelial progenitor cells in
      patients with metabolic syndrome and the changes dependent on physical activity of patients.
    


Intervention name(s): physical exercise
Intervention type(s): Behavioral
Intervention description(s): 8 weeks of regular exercise training
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: metabolic syndrome; HDL-Cholesterol; EPC; endothelial function; reduced blood HDL-Cholesterol level
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
Condition: Klinefelter Syndrome
MeSH terms: Klinefelter Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about
      body composition (muscle and fat) and male hormones and look at the effect of testosterone
      shots on body composition. The Investigators know that older boys and men with Klinefelter
      syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but
      we do not know if this difference is present at birth or develops over time. The
      Investigators will learn if body composition and motor skills are improved with testosterone
      treatment in infants with Klinefelter syndrome.
    


Intervention name(s): testosterone cypionate 200mg/ml
Intervention type(s): Drug
Intervention description(s): Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses.
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: body composition; Klinefelter syndrome; XXY; sex chromosome variation; sex chromsome aneuploidy
Treatment of Post-traumatic Stress Disorder With High Doses of Escitalopram
Condition: Stress Disorders, Post Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of
      chronic post-traumatic stress disorder (PTSD) in adult civilian survivors of traumatic
      events.

      Forty survivors of carefully documented traumatic events who had been followed for more than
      two years and have not improved will receive up to 40 mg of Escitalopram (daily) for twelve
      weeks

      Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical
      impression, as well as emergent side effects will be recorded every two weeks (one week for
      the first four weeks.

      The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or
      the last meeting with the patient - Last Observation Carried Forward).

      The secondary outcome criteria will be treatment continuation, as expressed in the proportion
      of patients leaving the study for either lack of effect or side effects.
    

Detailed description: 
      The study evaluates the hypothesis that large doses of Escitalopram will reduce symptoms of
      chronic post-traumatic stress disorder (PTSD)

      Forty adult survivors of carefully documented traumatic events who had been followed for more
      than two years and have not improved will receive up to 40 mg of Escitalopram (daily) for
      twelve weeks

      Symptoms of PTSD, depression, anxiety disorders, quality of life and global clinical
      impression, as well as emergent side effects will be recorded every two weeks (one week for
      the first four weeks.

      The primary outcome measure will be symptoms of PTSD as recorded at the end of the study (or
      the last meeting with the patient - Last Observation Carried Forward).

      The secondary outcome criteria will be treatment continuation, as expressed in the proportion
      of patients leaving the study for either lack of effect or side effects.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention description(s): Up to 40 mg oral dose in 10 or 20 mg tablets taken twice daily
Other intervention name(s): Lexapro, Cipralex
Intervention MeSH terms: Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTSD; Pharmacological Treatment; SSRI; Escitalopram; Anxiety Disorders
Evaluation of LUM001 in the Reduction of Pruritus in Alagille Syndrome
Condition: Alagille Syndrome
MeSH terms: Alagille Syndrome; Pruritus; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a randomized, double-blind, placebo-controlled study in children with Alagille
      Syndrome (ALGS). The study will investigate the effects of LUM001, compared to placebo, on
      pruritus, serum bile acids, liver enzymes, and other biochemical markers in patients with
      ALGS.
    


Intervention name(s): LUM001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LUM001 administered orally; Placebo administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Physical Training Combined Cardiac Resynchronization Therapy in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The investigators hypothesis that exercise training would potentiate the effects of cardiac
      resynchronization therapy in heart failure patients.
    


Intervention name(s): exercise training and/or CRT
Intervention type(s): Other
Intervention description(s): Three 40-minute exercise sessions per week on a treadmill for four months
Other intervention name(s): Untrained CRT patients; Exercise-trained CRT patients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiac resynchronization therapy (CRT)
A Timeline Study of Alcohol Use and Its Relationship to Insomnia
Condition: Insomnia; Alcohol Problem
MeSH terms: Sleep Initiation and Maintenance Disorders; Alcohol-Related Disorders
Study type: Observational

Summary: 
      This study is an epidemiological and descriptive study of the lifetime relationship of
      insomnia to alcohol problems.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We wish to study individuals who meet lifetime criteria for alcohol dependence, abuse or
        heavy drinking and who self-report current insomnia.
Intravenous Metoclopramide Versus Dexketoprofen Trometamol Versus Metoclopramide+ Dexketoprofen Trometamol in Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Acute headache is one of the most common reasons for presentation to the emergency department
      (ED), accounting for 2-3% of all emergency visits. Migraine is a disorder of the central
      nervous system characterized by a moderate or severe headache, which is generally associated
      with nausea and/or sensitivity to light and sound, interfering with daily activities.
    

Detailed description: 
      Study objective: The objective of this study is to determine the analgesic efficacy and
      safety of intravenous, single-dose metoclopramide versus dexketoprofen trometamol versus
      metoclopramide+ dexketoprofen trometamol in patients presenting with acute migraine attack to
      the emergency department (ED).

      Methods of Measurements:

      This single-center, randomized, double-blind study will be conducted in a tertiary care ED.
      Eligible patients who met the migraine criteria of the International Headache Society will be
      randomized to receive 10 mg intravenous metoclopramide, 50 mg intravenous dexketoprofen
      trometamol, or 50 mg dexketoprofen trometamol + 10 mg metoclopramide.

      Subjects reported pain intensity on both a 100-mm visual analogue scale (VAS) (limited by 'no
      pain' and 'the worst pain') will be used for pain measurement at baseline, after 15 and 30
      min. The primary outcome measure is the changes in the VAS scores at the 15th and 30th
      minutes of treatment. The secondary outcome measures are the presence of adverse effects and
      the requirement of rescue medicine.

      Primary Data Analysis:

      The study was planned as a superiority trial. The difference in the VAS values between the
      groups was assumed to detect 21.4 mm and the standard deviation (SD) value as 2.8 mm, and
      thus the minimum required the number of patients for each group was calculated as 27 at the
      alpha-critical value of 0.05 and power of 80%. All the analyses were implemented according to
      the intention to treat analysis. Differences between time intervals within groups and between
      groups and statistical significance were expressed by 95% confidence intervals (95% CI).
    

Intervention name(s): metoclopramide; dexketoprofen trometamol; metoclopramide+dexketoprofen trometamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 10 mg Metpamid in 100 ml normal saline solution; 50 mg dexketoprofen trometamol in 100 ml normal saline solution; 10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution
Other intervention name(s): Metpamid (metoclopramide); Metadem (dexketoprofen trometamol); Metpamid+Metadem
Intervention MeSH terms: Dexketoprofen trometamol; Ketoprofen; Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa
Condition: Intracytoplasmic Sperm Injection
Study type: Observational

Summary: 
      The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or
      severe oligozoospermia after use of ejaculated versus extracted testicular sperms in
      different cycles for the same patient.
    

Detailed description: 
      The study was carried out on couples who underwent ICSI in period 2012-2014 for male factor
      infertility.Patients with semen showing cryptozoospermia were candidates for inclusion in
      this study.

      First cycle was done as ICSI with priority to ejaculated sperm; testicular sperm was used if
      no motile sperm was available. For failed cases a second cycle was repeated using either
      testicular sperm or ejaculated sperm.

      Keywords:Cryptozoospermia, ejaculated spermatozoa, testicular spermatozoa, ICSI.
    

Intervention name(s): Intracytoplasmic sperm injection
Intervention type(s): Procedure
Intervention description(s): Intracytoplasmic sperm injection
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Infertile couples
Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study
Condition: Performance and Tolerance of Colonoscopy
Study type: Interventional

Summary: 
      Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete
      colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due
      to variations in patient anatomy, tortuous colons, and looping of the endoscope. Such
      obstacles can prolong colonoscopy, lead to complications, decrease polyp detection, and
      impact patient experience and tolerance. The investigators propose to evaluate the efficacy
      of a new non-invasive abdominal binder (ColoWrap®) in improving the performance and tolerance
      of colonoscopy by way of a randomized, blinded clinical trial. Eligible participants
      undergoing colonoscopy at University of North Carolina Hospitals (UNCH) will be recruited for
      the study and randomized to either the ColoWrap intervention or sham arm. Colonoscopy will be
      performed per usual operating procedures. The primary outcome will be time to distal extent
      (cecal intubation time). Secondary outcomes include colonoscopy completion rate, use of
      ancillary maneuvers, medication usage, procedural difficulty, patient comfort, and operator
      and assistant fatigue and pain. Efficacy will be assessed on the basis of pairwise
      comparisons between groups with respect to primary and secondary outcomes.
    


Intervention name(s): ColoWrap
Intervention type(s): Device
Intervention description(s): ColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy.
Other intervention name(s): ColoWrap abdominal binder; ColoWrap colonoscopy binder; ColoWrap device; ColoWrap binder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: Colonoscopy, Looping, Sigmoid Looping, ColoWrap, Binder, Patient Satisfaction