bioihbjkbjnl/mcl2 huggingface dataset:
A 12-week Field Trial of the Move Physical Activity Support Program
Condition: Overweight and Obesity; Physical Inactivity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The objective of this study is to design and refine an activity support program for
      overweight or obese adults called Move. The primary outcomes are feasibility and
      acceptability of the Move physical activity support program.
    

Detailed description: 
      The purpose of this study is to design and refine a physical activity support program called
      Move, designed for adults with overweight or obesity. Participants will receive a 12-week,
      virtual physical activity support program called Move. Move includes four intervention
      components: 1) 3, 60-minute group-based classes, 2) 3, 45-minute individualized support
      sessions, 3) access to an online fitness membership, and 4) mental guided imagery sessions.
      Participants will be asked to build their physical activity levels up to 150 minutes/week.
      The primary outcome is to evaluate the program's acceptability and feasibility from both the
      participant and the provider perspectives.
    

Intervention name(s): Move physical activity support program
Intervention type(s): Behavioral
Intervention description(s): The Move program includes four intervention components: 1) 3, 60-minute group-based classes, 2) 3, 45-minute individualized support sessions, 3) access to an online fitness membership, and 4) weekly mental guided imagery sessions. Participants will be asked to build up their physical activity levels up to 150 minutes/week. They will receive an online fitness center membership during this entire 12-week program.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neonates With Very Low Birth Weight and Surgery Therapy of Acute Abdomen
Condition: Very Low Birth Weight
MeSH terms: Body Weight; Birth Weight; Abdomen, Acute
Study type: Observational

Summary: 
      Objective:

      Due to high mortality rates the capillary leakage and the acute abdomen are important risk
      factors of the probability of survival. The aim of an optimal therapy of the acute abdomen
      within the neonatal period is beside the cure of the underlying disease the prophylaxis of
      capillary leakage with the help of optimised intra- and postoperative volume therapy.

      Question:

      Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit
      from early increase of the haemoglobin/haematocrit by optimised volume therapy with
      crystalloid and colloidal volume as prophylaxis of the capillary leakage?
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Neonates with very low birth weight and surgery therapy of acute abdomen
      
Keywords: Capillary leakage; Acute Abdomen; Low birth weight
Interbody Fusion Devices in the Treatment of Cervicobrachial Syndrome
Condition: Radiating Pain; Myelopathy; Cervicobrachial Syndrome
MeSH terms: Spinal Cord Diseases; Bone Marrow Diseases; Syndrome; Pain
Study type: Interventional

Summary: 
      This study randomizes neck and arm pain patients being treated with discectomy and anterior
      interbody fusion into two groups: one to receive a new ceramic implant and a control group
      with a more traditional plastic implant. The study will measure and compare pain and
      disability improvement with the two products over a period of two years. The fusion status
      will also be judged with plane x-rays and one CT scan.
    


Intervention name(s): Anterior cervical discectomy and fusion (ACDF) with PEEK Cage; Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage
Intervention type(s): Device; Device
Intervention description(s): Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer; Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.
Other intervention name(s): Medicrea Manta or similar PEEK cage; Valeo CSC (Cancellous Structured Ceramic); Silicon Nitride ceramic
Intervention MeSH terms: Silicon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervicobrachial pain; radicular pain; arm pain; myelopathy; radiculitis; Radiating pain with or without signs of myelopathy.
Clinical Trial of Several Contact Lenses in Extended Wear
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The study is to clinically evaluate currently marketed contact lenses when used in an
      extended wear modality of up to seven days/six nights.
    


Intervention name(s): senofilcon A; lotrafilcon A; lotrafilcon B; balafilcon A; comfilcon A; etafilcon A
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): 1 week extended wear contact lens; 1 week extended wear contact lens; 1 week extended wear contact lens; 1 week extended wear contact lens; 1 week extended wear contact lens; 1 week extended wear contact lens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Steady State Kinetics of l-Methamphetamine and Validation of Sensitivity of Dose Estimation
Condition: Nasal Congestion
Study type: Interventional

Summary: 
      The intent of this study is to see if the rate that the body breaks down l-methamphetamine
      (l-MA) could be used as an accurate estimate for the rate that the body breaks down
      d-methamphetamine (d-MA). l-MA is sold over the counter as a nasal decongestant where as d-MA
      is the commonly abused form of methamphetamine.
    

Detailed description: 
      Subjects will screen at St. Luke's Hospital in San Francisco to determine their eligibility.

      Once enrolled the study will take two weeks. During the first week subjects attend daily,
      hour-long outpatient visits at San Francisco General Hospital. At these visits subjects will
      receive an oral dose of l-methamphetamine, have their vitals read, answer questionnaires and
      receive a blood draw.

      During the second week of the study subjects are admitted to San Francisco General Hospital
      for a week long inpatient stay. During this stay the subject continues to receive
      l-methamphetamine but also receives three doses of d-methamphetamine on three separate days.
      In addition the subject receives blood draws, has their urine collected, and answers
      questionnaires.
    

Intervention name(s): l-methamphetamine; d-methamphetamine
Intervention type(s): Drug; Drug
Intervention description(s): 5mg of l-methamphetamine per day throughout the 2 week study; 15mg on Study Day 9, 30mg on Study Day 11, 45mg on Study Day 13
Other intervention name(s): l-MA; d-MA
Intervention MeSH terms: Methamphetamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: methamphetamine; inpatient; d-MA; l-MA; APRL; San Francisco; metabolism; Metabolism of methamphetamine
Maternal Immunization: Giving Immunity For Tomorrow
Condition: Pregnancy; Influenza
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      Study objectives are to compare

        -  influenza antibody levels in infant sera and maternal colostrum or breast milk at
           delivery, 2, and 6 months women who receive influenza immunization in early pregnancy,
           late pregnancy, or no influenza immunization during pregnancy and their infants

      Study hypotheses are that infants born to pregnant women who receive influenza immunization
      in late pregnancy will have

        -  higher levels and a longer serum influenza antibody duration in sera (hemagglutination
           inhibition (HAI) titers) and colostrum/breast milk (influenza-specific IgA and IgG by
           enzyme-linked immunosorbent assay (ELISA) than infants of women immunized in early
           pregnancy or not immunized
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women and their infants receiving care at University of Utah Health Sciences
        (UUHS) will be recruited and followed.
      
Keywords: Maternal immunization; Infant immunization; Influenza vaccine; Passive transfer of immunity
Evaluation of Varenicline Safety, Tolerability, Pharmacokinetics and Pro-Cognitive Effects in Healthy Elderly Non-Smoking Subjects
Condition: Healthy; Non-Smoking
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Characterize the tolerability and safety of repeated doses of varenicline in healthy
           non-smoking elderly subjects.

        2. Describe the steady state pharmacokinetics of varenicline in healthy non-smoking elderly
           subjects.

        3. Evaluate the potential effects of repeat doses of varenicline on cognition in healtly
           non-smoking elderly subjects.
    


Intervention name(s): varenicline; varenicline; varenicline; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.5 mg once daily for 7days followed by 0.5 mg twice daily for 7days followed by 1mg twice daily for 7 days; 0.5 mg once daily for 14 days followed by 1 mg once daily for 7 days; 0.5 mg once daily for 14 days followed by 0.5 mg twice daily for 7 days; Placebo for 21 days
Other intervention name(s): Champix, Chantix; Champix, Chantix; Champix, Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Safety, Tolerability, Pharmacokinetics, Cognition
Safety and Efficacy of Pravastatin in Relapsing-remitting Multiple Sclerosis
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Therapeutic strategies for multiple sclerosis (MS) are essentially based on the use of
      immunomodulatory agents such as interferon b and glatirmere acetate, but their efficacy is
      quite limited, they are not well tolerated and they have a very high cost. Recent works
      showed an immunomodulatory effects of HMG-CoA reductase inhibitors (the so-called "statins").
      In experimental allergic encephalopathy, a murine model of MS, statins inhibit the onset and
      progression of the disease through a shift from Th1 towards Th2 cytokine production. Other in
      vitro studies suggest the ability of statins to inhibit the lymphocyte migration through the
      blood brain barrier. Furthermore, in an open labeled human study in MS, statin regimen was
      associated with a decreased lesional activity assessed by MRI. Statins are well tolerated
      drugs, used for many years, with a low cost and with a putative efficacy in MS. The
      investigators suggest to test the pravastatin safety and efficacy on MRI criteria in a
      double-blind, placebo-controlled study in 40 patients with a relapsing-remitting MS.
    


Intervention name(s): Pravastatin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pravastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Effect of Wobenzym PS on Inflammation
Condition: Sub-clinical Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The general objective of this project is to examine the impact of Wobenzym PS supplementation
      on blood markers of inflammation and inflammation gene expression in volunteers with
      sub-clinical inflammation.

      The study will be undertaken according to a double-blind, cross over, randomized, placebo
      controlled design. The study will involve men and women with subclinical inflammation (n=24).
      Eligible subjects will have blood CRP >1 mg/L and <10 mg/L and will be in good health. The
      impact of Wobenzym PS on inflammation (vs. placebo) will be assessed by comparing the blood
      fasting concentrations and whole blood gene expression of anti- and pro-inflammatory proteins
      before and after the 4-week supplementation (Wobenzym and placebo). The two 4-week
      supplementation will be separated by a 4-week wash out period.
    

Detailed description: 
      Inflammation is being increasingly recognized as key etiological factor in the development of
      atherosclerosis and subsequent cardiovascular disease (CVD). This pro-atherogenic state is
      strongly correlated and often found co-segregating among individuals with obesity and
      metabolic syndrome. There is increasing evidence to support the use in clinical practice of
      these novel markers of atherosclerosis and CVD risk. C-reactive protein (CRP) has been used
      extensively as a non-specific marker of acute phase response in clinical practice for
      decades. More recently, CRP has also been proposed to be a new cardiovascular biomarker of
      atherosclerosis and its complications. Studies that have investigated the predictive value of
      sub-acute CRP levels have been relatively consistent in showing that individuals with high
      hsCRP (high-sensitivity C-reactive protein) levels (>3.0 mg/L) were at greater risk of CVD
      compared to individuals with lower (<1.0 mg/L) hsCRP levels, independent of gender and plasma
      cholesterol concentrations. Wobenzym is an enzyme formula primarily recommended for the
      treatment of pain and inflammation associated with musculoskeletal disorders. Several studies
      in the areas of arthritis and post-surgery have reported the acute anti-inflammatory effects
      of Wobenzym in terms of changes in CRP. Whether Wobenzym plays a role in managing sub-acute
      inflammation as well remains to be investigated.
    

Intervention name(s): Wobenzym PS; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Wobenzym
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Comparative Effects of Muscle Energy Technique and Routine Physical Therapy on Quadratus Lumborum in Patients With Chronic Low Back Pain
Condition: Chronic Low-back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      •Null hypothesis: There is no difference in effects of Muscle Energy Technique and Routine
      Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.

      •Alternative hypothesis: There is difference in effects of Muscle Energy Technique and
      Routine Physical Therapy on Quadratus Lumborum in patients with chronic low back pain.
    

Detailed description: 
      The purpose of the study is to compare the effects of Muscle Energy Technique and Routine
      Physical Therapy on Quadratus Lumborum in patients with chronic low back pain on Pain, Range
      of Motion, Quality of Life and Functional Disability.

      The study procedure will be explained to the patients and informed written consent will be
      obtained from those patients who will be willing to participate in the study. Quadratus
      Lumborum tightness will be assessed using side bending test.

      Those fulfilling the requirement of inclusion criteria will be indiscriminately separated
      into 2 groups. NPRS, Oswestry Disability Index, SF-20 and goniometer will be used to collect
      data.

      Total 68 participants will be recruited in the study. Routine Physical therapy will be
      provided to group A. Reciprocal inhibition Muscle Energy Technique on quadratus lumborum
      along with Routine Physical Therapy will be performed on group B.

      Both group will receive interventions three sessions in a week for 4 consecutive weeks.

      Assessment of Pain, Range of motion, Quality of Life and Functional Disability will be
      assessed by using goniometer, NPRS, Oswestry Disability Index and SF-20 Questionnaire
      respectively for both groups at the baseline, end of 6th session (2nd week) and end of 12th
      session (4th week) and follow up will be obtained after 1 month (8th week).
    

Intervention name(s): Routine Physical Therapy; Muscle Energy Technique
Intervention type(s): Other; Other
Intervention description(s): Routine physical therapy will be provided to group A for 25 minutes thrice a week for 4 weeks.; Muscle Energy technique along with Routine physical therapy will be provided to group B for40 minutes thrice a week for 4 weeks.
Other intervention name(s): Conventional Physical Therapy
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Lumbar pain; Backache; Muscle Energy Technique; Quadratus Lumborum
Assessment of the Wound Healing Efficacy and Tolerance of a Medical Device on Wounds in Healthy Subjects.
Condition: Healthy
Study type: Interventional

Summary: 
      The tested medical device is indicated for the treatment of wounds and small skin injuries.
      The intention of this study is to evaluate the tolerance and efficacy of the test product by
      measuring the recovery of the skin barrier after wound produced by suction blister. But also,
      by validating the accompanying physiological effect of the study product during this
      recovery.
    


Intervention name(s): Induction of suction blister; Transepidermal water loss (TEWL); Macrophotography; Wound healing medical device
Intervention type(s): Procedure; Other; Other; Device
Intervention description(s): For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.; At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
For subsequent visits, before product application; At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
For subsequent visits, before product application; Twice daily application on superficial wounds
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Heaklthy adult subject; Wound
Prevalence of Traumatic Events and PTSD in Immigrant and Non-immigrant Patients With Psychotic Disorder
Condition: Psychotic Disorders; Psychological Trauma; Stress, Psychological; Cross-Cultural Comparison
MeSH terms: Mental Disorders; Psychotic Disorders; Stress, Psychological; Psychological Trauma
Study type: Observational

Summary: 
      Higher rates of psychosis are described in migrant population. Likewise, this populations
      could suffer several adversities during migration process that could lead to higher exposure
      to traumatic events and higher rates of posttraumatic stress disorder (PTSD). There is a
      growing evidence that trauma is associated with psychosis onset.

      The aim of this research is to study the association between psychosis and traumatic events
      exposure/PTSD in immigrant population. Our hypothesis is that the higher incidence of
      psychosis described in immigrant population is associated to higher trauma exposure.

      A case-control observational study is performed. Patients who presented at least one
      psychotic episode are recruited from acute and chronic units at "Parc Salut Mar" (Barcelona).
      Estimated total sample is 196 individuals. Trauma exposure is assessed by validated trauma
      scales. Known factors associated with psychosis are controled during the statistic analysis.
    


Intervention name(s): Psychological trauma evaluation
Intervention type(s): Diagnostic Test
Intervention description(s): Psychological trauma exposure is assessed by validated scales:
Childhood Trauma Questionnaire (CTQ)
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Cumulative Trauma Scale.
The Holmes and Rahe Stress Scale.
Other clinical scales used:
Positive and Negative Syndrome Scale (PANSS).
Dissociative Experiences Scale (DES)
Mini-Mental State Examination (MMSE).
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who present, according DSM-V criteria, one or more non-affective psychotic
        episodes from Acute and Chronic inpatients units at Parc de Salut Mar (Barcelona).
Dronabinol Naltrexone Treatment for Opioid Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to
      maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that
      administering dronabinol during detoxification and during the first few weeks of naltrexone
      treatment will lead to improved naltrexone tolerability, resulting in better naltrexone
      compliance and treatment retention, and ultimately a reduction in opioid use and relapse
      rates.
    

Detailed description: 
      The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to
      maintenance treatment with naltrexone in opioid-dependent individuals. We are proposing a
      randomized, double-blind, placebo controlled, parallel-groups, 8 week study of relapse
      prevention in opioid-dependent individuals. Participants will be randomized into one of two
      conditions (1) Naltrexone and Placebo (N=20) and (2) Naltrexone and dronabinol 15 mg bid
      (N=40). Treatment will be delivered in an outpatient setting except for the initial phase of
      inpatient detoxification, lasting 8 days. A long-acting, injectable form of naltrexone 380 mg
      (Vivitrol) will be administered once per month (the total of two injections), while
      dronabinol or placebo will be taken daily. In addition, patients will receive a psychosocial
      intervention that will include elements of motivational interviewing and cognitive-behavioral
      relapse prevention therapy. The primary aim is to test the efficacy of dronabinol in
      improving tolerability of naltrexone induction and reducing attrition during detoxification
      and the first two months of naltrexone treatment. The primary outcome will be the severity of
      opiate withdrawal and craving. The secondary outcome will be will be retention in treatment
      at study's end.
    

Intervention name(s): injectable naltrexone and dronabinol; Naltrexone and placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment.; Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.
Intervention MeSH terms: Naltrexone; Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid dependence; naltrexone; vivitrol; dronabinol; marinol