bioihbjkbjnl/mcl2 huggingface dataset:
Asthma Action at Erie Trial
Condition: Asthma; Children
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The Asthma Action at Erie Trial compares the current best practice in asthma self-management
      education (certified asthma educator services) to an integrated community health worker (CHW)
      home intervention in which the real-life challenges of patients and the health care system
      are taken fully into account. This trial will provide clarity as to the expected effect size,
      cost savings, and resources needed to integrate asthma CHWs into clinical practice.
    

Detailed description: 
      The Asthma Action at Erie Trial will test the ability of a community health worker (CHW)
      intervention with three important modifications to achieve asthma control in high-risk
      children. These modifications are: 1) CHWs will be integrated into both the clinical and the
      home setting, 2) A system for directly addressing mental health and psychosocial barriers
      will be provided, and 3) Participants will be provided only materials and equipment for
      trigger remediation that are supported by the current medical reimbursement system. To test
      this intervention, a two-arm behavioral randomized controlled trial (N=220) will be conducted
      in partnership with a federally-qualified health center (FQHC) serving a low income, minority
      population that is at high-risk for significant asthma morbidity. The intervention arm will
      receive an integrated CHW home intervention for pediatric asthma education. The comparison
      arm will received clinic-based certified asthma educator (AE-C) services. Primary Aim 1 is to
      assess the efficacy of the integrated CHW home asthma intervention, relative to clinic-based
      AE-C education over 12-months, as demonstrated by asthma control. Specific Aim 2 is to assess
      maintenance of intervention efficacy, as demonstrated by asthma control at 18 and 24 months
      after randomization. Specific Aim 3 is to determine the cost-effectiveness at 12-months of
      CHW and AE-C intervention delivery, and additional costs or savings related to asthma
      exacerbations at 12- and 24-months. Specific Aim 4 is to assess the efficacy of the
      integrated CHW home asthma intervention relative to clinic-based AE-C education, as
      demonstrated by asthma control, among those experiencing depression, stress, and/or a
      post-traumatic stress disorder.
    

Intervention name(s): Community Health Worker; Certified asthma educator
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A community health worker is para-professional who performs education, case management, and social support.; A certified asthma educator has is certified and performs asthma education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of IBI353 (Orismilast) in Chinese Healthy Adults
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in Chinese population study to evaluate the safety, tolerability, PK and PD
      of multiple dose of modified-release IBI353 administered orally in healthy subjects. The
      study enrolls 20 healthy subjects and consists of 1 week of screening, 3 weeks of treatment
      period and 1 week of safety follow up after completion of last dose.
    


Intervention name(s): IBI353 (Orismilast); placebo
Intervention type(s): Drug; Drug
Intervention description(s): dose 1 or dose 2; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
High-fat Yogurt and Plasma Lipids Profile
Condition: Plasma Lipid Profile
Study type: Interventional

Summary: 
      The goal of this clinical trial is to compare the effect of saturated fat intake from
      different source on cardiometabolic risk markers in healthy subjects. The main question it
      aims to answer are:

      -Does intake of saturated fat in the form of high-fat yogurt have a different effect on
      cardiometabolic risk factors than intake of the same amount from butter? In this study, in
      two periods of 4 weeks, the effect of receiving saturated fat from high-fat yogurt compared
      to receiving the same amount of saturated fat from butter and low-fat yogurt on the plasma
      concentration of lipids, cholesterol, insulin, and some inflammatory factors will be studied
      in healthy subjects.
    


Intervention name(s): saturated fat intake
Intervention type(s): Other
Intervention description(s): Intake of saturated fat from yogurt and animal butter daily for 4-week period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
LESS Surgery Versus Conventional Multiport Laparoscopy in Ovarian Drilling
Condition: Successful Surgical Procedure; Operative Time; Cosmetic Outcome; Intra- and Post- Operative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      laparoendoscopic single-site surgery is compared to conventional multi-port laparoscopy for
      polycystic ovary syndrome in infertile women undergoing ovarian drilling as regards
      successful surgical procedure with less side effects
    

Detailed description: 
      Laparoendoscopic single-site surgery; one of the most recent advances in the field of
      minimally invasive surgery, is the use of a single incision in the umbilicus for laparoscopic
      surgeries, is compared to the conventional multi-port laparoscopy for polycystic ovary
      syndrome in infertile women undergoing ovarian drilling as regards successful surgical
      procedure without conversion to laparotomy or use of an additional port in the single site
      group. in addition to operative time, intra- and post- operative complications and cosmetic
      outcome.
    

Intervention name(s): laparoscopic ovarian drilling
Intervention type(s): Device
Intervention description(s): laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: women fulfilled the inclusion criteria and consented will be included in the study and randomly assigned into two groups using computer random sequence generator.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: LESS surgery; conventional multi-port laparoscopy; SILS; Single-site surgery; Covidien; laparoscopy; minimally invasive surgery; ovarian drilling; PCOS; Diagnostic laparoscopy
MR Imaging of the 3D Inguinal Hernia Scaffold ProFlor
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Demonstrating through MRI sequuences the regenerative features of the 3D inguinal hernia
      scaffold ProFlor
    

Detailed description: 
      The biological response of the 3D inguinal hernia scaffold ProFlor has been evaluated through
      MRI signal intensity (SI) at three defined post-implantation stages: short, mid and long
      term. The SI of ProFlor has been compared to the SI of the neighbouring muscles and fat. As
      additional proof, histology of tissue specimens excised at the identical post-implantation
      stages from porcine models in the fame of a previous experimental attempt were also
      evaluated. The results of this experimental trial have ben already published in 2011 - ref: A
      new prosthetic implant for inguinal hernia repair: its features in a porcine experimental
      model. Artificial Organs 2011;35(8):E181-E190
    

Intervention name(s): ProFlor inguinal hernia device
Intervention type(s): Device
Intervention description(s): Device follow up after inguinal hernia repair with ProFlor
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
68Ga-PSMA-11 PET in Patients With Prostate Cancer
Condition: Prostate Cancer; Prostate Adenocarcinoma
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients will receive a single dose of 68Ga-PSMA-11 and undergo a PET/CT or PET/MRI imaging
      study.
    

Detailed description: 
      This is a prospective, Phase III, single-center, open-label to provide extended access in
      patients with biochemically recurrent prostate cancer. Approximately 100 patients are planned
      for enrollment in this study. Patients will receive a single dose of 68Ga-PSMA-11 and undergo
      a PET/CT or PET/MRI imaging study.

      The intervention is a PET scan with the radiolabelled Prostate-specific membrane antifen
      (PSMA) ligand, 68Ga-PSMA-11. The PET may be combined with a CT scan as a PET/CT or an MRI
      scan as PET/MRI. 68Ga-PSMA-11 PET/CT will be acquired using a modern digital GE PET/CT
      scanner or a modern digital PET / MRI scanner.

      AEs will be collected during injection and uptake phase (45-120 min posts infusion) of Ga-68
      PSMA-11 PET/CT scan. All safety events will be recorded up to 120 min post injection.

      Men with pathologically proven prostate adenocarcinoma, high risk cancer at diagnosis,
      evidence of biochemical recurrence, or known metastatic disease planned to start and change
      systemic therapy regimen.

      One intravenous catheter will be placed for radiopharmaceutical administration. Patients will
      be injected with 100 MBq (3mCi)-300 MBq( 7mCi) of 68Ga-PSMA-11 via this catheter.
    

Intervention name(s): Ga-PSMA-11
Intervention type(s): Drug
Intervention description(s): The PSMA Sterile Cold Kit, is a kit comprising all needed materials (lyophilized PSMA for PSMA reconstitution, elution vial for Ga and ancillary materials for transfer between vials) to perform a room-temperature radiolabelling of PSMA-11 with Ga. Ga is not part of the kit and should be provided in the form gallium chloride solution following the requirements of the relevant local regulations. PSMA-11 radiolabelled with Ga is administered in patients with prostate cancer recurrence after radical treatment.
Intervention MeSH terms: Gallium 68 PSMA-11
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Newly Diagnosed
Phase I Study of the Safety, Tolerability, PK & PD of Lomitapide in Japanese and Caucasian Subjects With Elevated LDL-C
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and
      multiple ascending dose (MAD) study of orally administered lomitapide in healthy male
      Japanese and Caucasian subjects with elevated LDL-C. The purpose for this study is to
      evaluate the PK and PD of lomitapide in Japanese subjects as compared to Caucasian subjects.
    


Intervention name(s): lomitapide
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transcranial Magnetic Stimulation to Augment Behavior Therapy for Tics
Condition: Tic Disorders; Tics; Tic, Motor; Tic Disorder, Childhood; Tourette Syndrome; Tourette Syndrome in Children; Tourette Syndrome in Adolescence
MeSH terms: Tourette Syndrome; Tics; Tic Disorders; Syndrome
Study type: Interventional

Summary: 
      The study will examine whether combining Comprehensive Behavioral Intervention for Tics
      (CBIT) with inhibition of the supplementary motor area (SMA) using transcranial magnetic
      stimulation (TMS) normalizes activity in the SMA-connected circuits, improves tic suppression
      ability, and enhances CBIT outcomes in young people with tic disorder. The study will also
      examine different TMS dosing strategies.
    

Detailed description: 
      All participants will receive 10 daily sessions of CBIT, a well-established behavioral
      treatment that is considered by the American Academy of Neurology to be the first-line
      intervention for tics. Immediately prior to each CBIT session, participants will undergo TMS
      targeting the SMA. The specific type of TMS procedure will be randomly assigned between
      subjects and be either: 1 Hz repetitive TMS (rTMS), continuous theta burst stimulation
      (cTBS), or sham stimulation.
    

Intervention name(s): Comprehensive Behavioral Intervention for Tics (CBIT); Repetitive Transcranial Magnetic Stimulation (rTMS); Continuous Theta Burst Stimulation (cTBS)
Intervention type(s): Behavioral; Device; Device
Intervention description(s): CBIT is a manualized treatment program focused on tic management skills; During repetitive transcranial magnetic stimulation (rTMS), a electromagnetic coil is placed against the scalp while an electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the target brain region; During continuous theta burst stimulation (cTBS), a electromagnetic coil is placed against the while an electromagnet painlessly delivers magnetic bursts that stimulate nerve cells in the target brain region
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence of Two Formulations of Biphasic Insulin Aspart 50 in Healthy Male Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Africa. The aim of this trial is to investigate the bioequivalence
      of two formulations of biphasic insulin aspart 50 in healthy male subjects.
    


Intervention name(s): biphasic insulin aspart 50
Intervention type(s): Drug
Intervention description(s): A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of the Efficacy of Endermologie in Treatment of Cellulite and Body Contouring
Condition: Cellulite; Body Contouring
MeSH terms: Cellulite
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to perform a clinical assessment of the efficacy of the device
      DHERMIA® (Industra Mecânica Fina Ltda)in the treatment of cellulite and body contouring
    

Detailed description: 
      The present study is a clinical, opened trial and single-center.

      The patients were treated by endermologie device. Mechanical massage were performed for 12
      weeks in a total of 24 treatment sessions: twice a week.

      A set of photographs were took at visit 1 (baseline), visit 2, 3 and 4 with standardized
      positions and lighting conditions.
    

Intervention name(s): Dhermia® - Industra Mecânica Fina Ltda
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm
Condition: Abdominal Aortic Aneurysm
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
Study type: Observational

Summary: 
      It has been estimated that 80% of deaths from abdominal aortic aneurysms results from
      rupture. Endovascular Aneurysm Repair (EVAR) has been applied to RAAA (Ruptured Abdominal
      Aortic Aneurysm) patients with reports of improvements. Despite the use of EVAR, patients
      have developed complications with lung and kidney function. This study will investigate
      certain biochemical processes that will potentially reduce these complications. Knowledge
      gained from this study may also be used to further research in this field through larger
      studies.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Those undergoing AAA repair for elevtive and ruptured AAA by both EVAR and open methods.
      
Biospecimen description: 
      plasma
    
Keywords: Open/Elective EVAR patients
A Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir With Sofosbuvir With or Without Ribavirin in Adults With Chronic Hepatitis C Virus Infection
Condition: Chronic Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Ombitasvir
      (OBV)/paritaprevir (PTV)/ritonavir (r) with sofosbuvir (SOF) with or without ribavirin (RBV)
      in adults with Genotype 2 Chronic Hepatitis C Virus (HCV) infection or Genotype 3 HCV
      infection with or without Cirrhosis.
    


Intervention name(s): OBV/PTV/r; Sofosbuvir; Ribavirin (RBV)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet
Other intervention name(s): ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ritonavir (r) also known as Norvir; VIEKIRAX combination tablets; TECHNIVIE; Sovaldi
Intervention MeSH terms: Ritonavir; Ribavirin; Sofosbuvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Virus; Genotype 2; Chronic Hepatitis C; Genotype 3; Non-cirrhotic; Cirrhotic
Cardiovascular Risk in Growth Hormone Deficient Young Adult Males After Completing Growth Hormone Therapy
Condition: Growth Hormone Deficiency
Study type: Observational

Summary: 
      The purpose of this study is to compare the cardiovascular risks of growth hormone deficient
      young adult males who have completed growth hormone therapy to healthy young adult males.
    

Detailed description: 
      Adults with growth hormone deficiency are at risk for cardiovascular disease. What age this
      begins is not known.

      The objectives of this study are to compare the following measurements between growth hormone
      deficient young males 3-7 years post completion of growth hormone treatment and age related
      healthy controls:

        1. Carotid artery imaging

        2. Metabolic and cardiac parameters

        3. Body composition measurements
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Endocrine clinic and community sample
The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics
Condition: Respiratory Pathogens; Upper Respiratory Tract Illness; Lower Respiratory Tract Illness; Acute Respiratory Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional

Summary: 
      The RAPID trial is a randomized controlled trial that looks at the clinical impact of a rapid
      respiratory test in a pediatric emergency department. Participants will be randomized to the
      intervention group - results available to medical providers, or the control group- results
      not available to medical providers.
    

Detailed description: 
      The RAPID trial is a randomized controlled trial of rapid respiratory viral testing in
      children presenting to an Emergency Department setting with acute respiratory symptoms. The
      patient cohort will be children 1 month to 18 years of age presenting to the Children's
      Hospital Colorado (CHCO) Emergency Department with influenza like illness who are triaged as
      level 3, 4, or 5 by the Emergency Severity Index, representing the typical patient population
      who are evaluated in an urgent care setting. All eligible participants will undergo a
      nasopharyngeal swab and point of care testing, and participants will be allocated 1:1 by
      computer-generated randomization to either the intervention group - test result available to
      providers, or the control group- test result not available (routine clinical care). The
      investigators will compare the clinical outcomes between the two groups.
    

Intervention name(s): Results available to provider
Intervention type(s): Diagnostic Test
Intervention description(s): Results of point of care testing are given to provider
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be allocated 1:1 by computer-generated randomization to either the intervention group - test result available to providers, or the control group- test result not available (routine clinical care).
Masking: None (Open Label)
Primary purpose: Other
A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of the study was to compare the clinical performance of the two contact lenses
      when used in combination with three care systems.
    

Detailed description: 
      This was a randomized, open-label, crossover study, controlled by cross-comparison. Subjects
      were randomized to wear each lens and solution combination for a month in random sequence;
      that is for a total of six months.
    

Intervention name(s): comfilcon A; fanfilcon A
Intervention type(s): Device; Device
Intervention description(s): Subjects were randomized to wear each lens and solution combination for a month.; Subjects were randomized to wear each lens and solution combination for a month.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will use each lens and solution combination for a month in random sequence for a total of six months.
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Clobetasol Propionate Versus Hydrocortisone in Children With Alopecia Areata
Condition: Alopecia Areata
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      The use of topical steroids in the treatment of alopecia areata in children is common
      practice. However, no particular potency of steroid is accepted as the standard treatment due
      to the paucity of high quality evidence in the dermatology literature to substantiate their
      use. Two randomized controlled trials exist assessing topical steroid efficacy in this
      disorder, both have methodological limitations. The question remains as to which topical
      steroid is safe and efficacious for use. We performed a double blinded controlled trial to
      assess the usefulness of a class 1 topical steroid (clobestasol proprionate 0.05%) compared
      with a class 7 topical steroid (hydrocortisone 1%) in children with alopecia areata.
    


Intervention name(s): Hydrocortisone 1%; Clobetasol Propionate 0.05%
Intervention type(s): Drug; Drug
Intervention description(s): Topical cream, used twice daily for 6 weeks on affected area, followed by 6 weeks of no treatment, followed by an additional 6 weeks of the same intervention.; Topical cream, used twice daily for 6 weeks on affected area, followed by 6 weeks of no treatment, followed by an additional 6 weeks of the same intervention.
Intervention MeSH terms: Hydrocortisone; Clobetasol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alopecia Areata; Hydrocortisone; Clobetasol Propionate; Randomized Controlled Trial