bioihbjkbjnl/mcl2 huggingface dataset:
RAMBAM 021: Safety and Initial Feasibility of the Neurolyser XR for the Treatment of Chronic Low Back Pain
Condition: Facet Syndrome of Lumbar Spine
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a
      high intensity focused ultrasound device, for non-invasive treatment of axial chronic low
      back pain
    

Detailed description: 
      Study design: Prospective, single arm

      Timeline: six month enrollment period and 12 months follow-up period.

      Sites: The study will be conducted at five sites in Canada: McGill University, Toronto
      Western, Silver Medical Group, Precision Sport & Spine, Kinetix Integrated Orthopaedic &
      Regenerative Medicine

      Study population: Thirty adult patients diagnosed with facet related low back pain.

      Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of
      chronic low back pain secondary to zygapophyseal joint syndrome.

      Safety is measured by the incidence and severity of treatment related adverse events.

      Efficacy is measured by the changes in pain severity at the treatment area, using a numerical
      rating scale (NRS), of 0 to 10 between baseline and 6 months.
    

Intervention name(s): Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR
Intervention type(s): Device
Intervention description(s): Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
Intervention model: Single Group Assignment
Intervention model description: Single arm, non-randomized
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Efficacy of Vardenafil in the Treatment of Subjects With Symptomatic Benign Prostatic Hyperplasia
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2

Summary: 
      Assessment of efficacy of vardenafil in the treatment of subjects with symptomatic Benign
      Prostatic Hyperplasia.The purpose of this study is to find out whether vardenafil can improve
      the lower urinary tract symptoms of benign prostatic hyperplasia after 8 weeks of daily
      administration of 10 mg BID.
    


Intervention name(s): Levitra (Vardenafil, BAY38-9456); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg Vardenafil bid; Matching placebo
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Benign Prostate Hyperplasia; Vardenafil; Genital Disease; Male: Signs and symptoms of Benign Prostate Hyperplasia
Yoga Intervention Study on Episodic Tension Type Headache
Condition: Episodic Tension Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The present study was designed to evaluate effect of yoga intervention on patients having
      frequent tension type headache.
    


Intervention name(s): Yoga Therapy
Intervention type(s): Behavioral
Intervention description(s): Therapeutically oriented style of yoga originated from Pancha Kosha philosophy of Vedanta was used throughout the trial. All the sessions emphasized on postures, breathing practices with the specific focus on relaxation, combination of chants and meditation. Once a week, Kunjal and Jalaneti (cleansing practices) were practiced in guidance of therapist. They all were instructed to eat light and rest on Kriya days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Dentine Tubule Occlusion Assessment in a Modified in Situ Model
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity
Study type: Interventional

Summary: 
      This will be a single centre, single blind, randomized, three treatment, three period
      crossover design, modified, in situ, study in healthy participants. In this in situ model the
      tubule occlusion properties of dentifrices will be evaluated by comparing an experimental
      dentifrice formulation to a regular fluoride dentifrice and a negative control (mineral
      water) over a ten day period.
    

Detailed description: 
      This modified in situ model study will evaluate the mode-of-action of an experimental
      dentifrice containing stannous fluoride to occlude tubules compared to a regular fluoride
      dentifrice and a negative control (mineral water). The study treatments will be administered
      for a total of 10 days, with participants wearing two appliances in their mouth that will
      hold samples of dentine. The dentine samples will be examined after 1, 4, 8 and 10 days of
      treatment using scanning electron microscopy (SEM) and the resulting images graded for the
      amount of occlusion. In addition, the robustness of any occlusion generated by the treatments
      will be tested by exposing the dentine samples to an acid challenge (orange juice) after 9
      and 10 days treatment.
    

Intervention name(s): Stannous fluoride; Sodium monofluorophosphate; Mineral water
Intervention type(s): Device; Other; Other
Intervention description(s): Dentifrice containing 0.454% stannous fluoride; Dentifrice containing 0.76% sodium monofluorophosphate; Commercially available mineral water
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Medical Marijuana Use in HIV+ Patients: Probability Survey
Condition: HIV Positive
MeSH terms: HIV Seropositivity; Marijuana Use
Study type: Observational

Summary: 
      More scientific information is needed about medical marijuana use among HIV positive
      patients. There is conflicting information about the use of marijuana, use of medical
      marijuana, and the associations between them and health status/health risk behaviors/health
      care utilization. In addition, it is not clear whether patients who participate in
      prospective clinical studies differ from participants who do not participate; if there are
      differences between those two groups, then this would limit generalizability of knowledge
      about these issues.

      The goal of this project is to describe the use of marijuana among HIV positive patients and
      its association with health status/health risk behaviors/health care utilization.
    

Detailed description: 
      Participants will answer questions about marijuana, medical marijuana, and other drug use. We
      will also ask about health and steps participants take to keep healthy. The study will take
      up to one hour to complete.

      Participants will also be asked to sign a release of information form. This form would allow
      us to look at medical records at the HIV clinic.
    

Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        HIV positive
      
Keywords: HIV positive
Health2006 - an Observational Study of Cardiovascular Disease, Diabetes, Asthma and Allergy
Condition: Cardiovascular Disease; Type 2 Diabetes; Asthma; Hypersensitivity; Osteoporosis
MeSH terms: Osteoporosis; Asthma; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypersensitivity
Study type: Observational

Summary: 
      The aim is to assess the population prevalence of risk factors for different chronic diseases
      such as cardiovascular disease, type 2 diabetes, osteoporosis, asthma, and allergy. Risk
      factors include genetic and serologic biomarkers, questionnaire data on health and lifestyle.
      There are many hypotheses under study for each research field.
    

Detailed description: 
      A population-based random sample of persons living in Copenhagen is drawn from the Danish
      Civil Registration System and invited for a health examination including blood sample
      drawing, measurement of lung function, serologic and genetic biomarkers, questionnaires on
      lifestyle and health. The study will form the basis for research within many different areas
      such as cardiovascular disease, type 2 diabetes, asthma, and allergy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Random sample of citizens living in 11 municipalities in Copenhagen. Age 18-69 years.
      
Biospecimen description: 
      Extracted DNA, urine, serum
    
Keywords: epidemiology; risk factors
Acute Effects of Static Stretching Duration on Gastrocnemius Muscle Vascularization
Condition: Muscle Stretching Exercises
MeSH terms: Neovascularization, Pathologic
Study type: Interventional

Summary: 
      Stretching effects skeletal muscle flexibility, vascularity and physical performance. The aim
      of our study is to examine the acute effects of static stretching duration on gastrocnemius
      muscle vascularization in healthy participants by superb microvascular imaging (SMI) and to
      compare the effects of 2 and 5 minutes of static stretching on blood flow.
    

Detailed description: 
      The study will be included 30 healthy volunteers. The participants will be divided into two
      groups. Static stretching was administered to the gastrocnemius muscle. Stretching
      applications will be applied to the first group for 2 minutes and to the second group for 5
      minutes. Muscle vascularization will be evaluated by a new method, superb microvascular
      imaging (SMI). SMI is a recently developed ultrasound imaging technique that aims to
      visualize low velocity and small diameter blood vessel flow.
    

Intervention name(s): 2 Minute Static Stretching; 5 Minute Static Stretching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Stretching applications will be applied to the first group for 2 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.; Stretching applications will be applied to the first group for 5 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Gastrocnemius; Static Stretching; Muscle Vascularization; Superb Microvascular Imaging
Infant Environment Study
Condition: Infant Development; Motivation
Study type: Interventional

Summary: 
      This study evaluates the effect of a music enhancement program to strengthen the motivation
      to engage in music related behaviors rather than eating in infants who are high in motivation
      to eat. Half the participants will participate in a Music Together Program, while the other
      half will participate in a Play Date control. For both groups, participants will attend 34
      weekly sessions for one year, and 12 monthly sessions the next year, in 6 cohorts.
    

Detailed description: 
      Obesity is a disorder of positive energy balance in which energy intake exceeds energy
      expenditure. The motivation to eat is a basic human need, which is present at birth. One
      factor that may lead to increased energy intake is the imbalance between the motivation to
      eat and the motivation to engage in other behaviors. The motivation to eat versus engaging in
      other behaviors can be operationalized as the relative reinforcing value of eating versus
      alternative behaviors.

      A strong motivation to eat instead of engaging in alternative behaviors has been related to
      increased energy intake in adults. The motivation to eat is cross-sectionally and
      prospectively related to obesity in children, adolescents, and adults, and cross-sectionally
      related to weight status in infants. Shifting the balance from high motivation to eat to
      increased motivation to engage in alternative behaviors can reduce energy intake, and may be
      protective against weight gain.

      A structured program to enhance music engagement in infants who are strongly motivated to eat
      can shift their choice from food to music. This study will expand on this preliminary
      research and examine long-term effects of this intervention in infants who are highly
      motivated to eat.
    

Intervention name(s): Music Enhancement; Play Date
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Coronary CT Angiography Using a Novel 3rd Generation Dual-Source CT System
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Coronary CT angiography is used to examine the coronary arteries in a non-invasive way when a
      patient is suspected of having coronary artery disease. The test, however, requires
      relatively high levels of radiation, which have been linked to DNA damage and cancer, and the
      use of contrast material, which can affect kidney function. The SOMATOM Force, a new
      third-generation CT scanner manufactured by Siemens, was recently installed at MUSC and holds
      the potential to obtain quality images while also reducing radiation dose and contrast
      material. This study aims to test the diagnostic ability of the SOMATOM Force in detecting
      coronary artery disease and also see if radiation dose and contrast material are reduced
      compared to the previous 2nd generation scanners. It is suspected that the Force will provide
      clinical quality images while decreasing radiation dose and contrast material required.
    


Intervention name(s): Coronary CT angiography on SOMATOM Force; Previous coronary CT angiography on 2nd generation CT scanner
Intervention type(s): Procedure; Procedure
Intervention description(s): Coronary CT angiography using iodinated contrast; metoprolol and/or nitroglycerin may also be administered on a per-patient basis; Clinically indicated coronary CT angiography previously performed on a 2nd generation CT scanner
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Influence of Cholecystectomy on Secretion of Incretin Hormones
Condition: Glucose Metabolism Disorders
MeSH terms: Metabolic Diseases; Glucose Metabolism Disorders
Study type: Observational

Summary: 
      The effect of cholecystectomy on postprandial plasma GLP-1 responses (primary endpoint) and
      glucose metabolism will be evaluated in 30 patients planned to undergo elective laparoscopic
      cholecystectomy.
    

Detailed description: 
      This is an observational, parallel-group study in 30 patients with gallstone disease and 10
      healthy control subjects. In patients undergoing cholecystectomy a 4h-meal test (liquid mixed
      meal) will be conducted at baseline (1-2 weeks before surgery) and again within 4 weeks after
      the cholecystectomy. Healthy subjects will be submitted to a single 4h-meal test.

      Secondary endpoints include changes in plasma glucose, insulin, glucagon, GIP, PYY, gastrin,
      CCK, fibroblast growth factor 19 (FGF-19) and bile acids. Furthermore, secondary endpoints
      include changes in gastric emptying (evaluated by the paracetamol method).
    

Intervention name(s): cholecystectomy
Intervention type(s): Procedure
Intervention description(s): elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A healthy, normal weight population undergoing elective surgery because of gall stone
        disease.
      
Biospecimen description: 
      biopsies from the gallbladder and ductus cysticus after cholecystectomy biopsies only
      collected from 12 subjects.
A First Time in Human Study to Assess GSK2336805 in Healthy Volunteers and Single Doses in Chronically Infected Hepatitis C Patients.
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a three Part, Phase 1, randomized, dose-escalation, fusion, placebo-controlled,
      double-blind study to determine the safety, tolerability and Pharmacokinetic (PK) profile of
      GSK2336805 in healthy subjects and the safety, tolerability, PK, and antiviral profile of
      GSK2336805 in subjects chronically infected with HCV: i. Single doses in healthy subjects and
      the effect of food on GSK2336805 PK (Part 1). ii. Repeat doses in healthy subjects (Part 2)
      iii. Single doses in chronically infected HCV positive subjects (Part 3).
    


Intervention name(s): GSK2336805 10mg; GSK2336805 30mg; GSK2236805 100mg; GSK2236805 200mg; GSK2236805 10mg; GSK2236805 dose to be determined up to 100mg; GSK2236805 5mg; GSK2236805 30mg; GSK2236805 100mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single dose once daily; single dose once daily; single dose once daily; single dose once daily; repeat dose once daily for 7 days; repeat dose once daily for 7 days; single dose in HCV infected patients; single dose in HCV infected patients; single dose in HCV infected patients
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: First administration to human, safety, pharmacokinetics, healthy subjects, antiviral activity, hepatitis C patients
Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)
Condition: Depressive Disorders; Psychotic Disorders; Depression
MeSH terms: Depression; Depressive Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients who participated in the previous trial 28130, who were eligible, were entered into
      this trial. Patients who were randomized to placebo in the previous trial 28130 continued on
      placebo while patients who were randomized to Org 34517 (SCH 900636), regardless of dose,
      were titrated to 900 mg Org 34517. Patients in this trial took their study medication for 2
      weeks in order to study the safety and tolerability of Org 34517.
    


Intervention name(s): SCH 900636; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Org 34517 300 mg on Day 1, 600 mg on Day 2, then 900 mg daily starting from Day 3. Subjects in this arm were also to continue the "usual treatment" for psychotic major depression.; Placebo
Other intervention name(s): Org 34517
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Middle School to High School Transition Project: Depression and Substance Abuse Prevention
Condition: Depression; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will implement a school-based program to prevent depression, academic failure, and
      substance use in at-risk adolescents transitioning from middle school to high school.
    

Detailed description: 
      The transition from middle school to high school presents important challenges for
      adolescents. Programs that enhance personal efficacy and social support resources may prevent
      at-risk students from developing behaviors that can lead to substance use, academic failure,
      and depression. This study will implement a skills-based program called Coping and Support
      Training for the Transition (CAST-T) as a preventive intervention for at-risk students.

      At-risk students in eighth grade will be randomly assigned to receive either CAST-T or school
      as usual. The CAST-T program will initially be delivered in twelve sessions over 6 weeks in
      the middle school setting. The program includes booster sessions, case management, structured
      home-based parent education, and support and skills training throughout the transition
      period. Participants will be assessed from the beginning of eighth grade to the end of ninth
      grade. Vulnerability to academic problems and depression will be assessed with school records
      and self-report scale scores.
    

Intervention name(s): CAST-T/HSTS; Brief Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Skills training small group.; Assessment of needs and referral to services as needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; Substance Abuse; At-risk
Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up
Condition: Medical Abortion
Study type: Observational

Summary: 
      This study will examine the feasibility, acceptability and usability of a semi-quantitative
      urine pregnancy test (dBest One Step hCG Panel Test Kit) for at-home follow-up after early
      medical abortion using mifepristone+misoprostol. The study seeks to:

        1. Assess the feasibility of using this test in lieu of standard one-week clinic-based
           follow up for determination of complete abortion status as part of normal service
           delivery. In Mexico, follow up will be in two weeks, as is standard care in that .

        2. To determine if women using this test at home understand how to use it and can correctly
           interpret the results; is it practical.

        3. Assess women's and provider's acceptability of using at-home pregnancy tests in lieu of
           clinic-based follow up for confirmation of complete medical abortion in the future.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women presenting to clinic seeking medical abortion
      
Keywords: medical abortion; Medical Abortion Follow Up Care
Semaglutide vs Dulaglutide on Epicardial Adipose Tissue
Condition: Epicardial Fat
Study type: Observational

Summary: 
      Epicardial Fat (EAT), the visceral fat depot of the heart, is a modifiable cardio-metabolic
      risk factor and therapeutic target. EAT expresses GLP-1 receptors (GLP-1R). GLP-1 receptor
      agonist liraglutide is known to significantly decrease EAT thickness. However, the effects of
      GLP-1 receptor agonists semaglutide and dulaglutide on EAT thickness are unknown
    

Detailed description: 
      This is a retrospective, observational, case control study. Data were obtained from
      retrospective review of the electronic medical records.

      Patients were treated with either semaglutide, dulaglutide or metformin as standard of care,
      during routine clinical practice, regardless of the study. Each patient underwent routine
      labs and an onsite ultrasound measurement of EAT thickness at baseline and at the routine
      12-week follow up visit, as standard of care.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Type 2 diabetic subjects who routinely come to the University of Miami Division of
        Diabetes, Endocrinology and Metabolism outpatient diabetic clinic, as standard of care.