bioihbjkbjnl/mcl2 huggingface dataset:
A Text Message Behavioral Intervention to Reduce Alcohol Consumption in Young Adults
Condition: Alcohol Consumption; Alcohol Intoxication
MeSH terms: Alcoholic Intoxication; Alcohol Drinking
Study type: Interventional

Summary: 
      Investigators aim to test the effectiveness of a text-message-based behaivoral intervention
      in reducing binge drinking among young adults.
    

Detailed description: 
      Alcohol consumption, especially in the form of heavy episodic drinking (bingeing), is common
      among young adults. Despite high rates of illness and injury associated with heavy episodic
      drinking, many young adults are not aware of the risks, few seek help for their drinking and
      many at-risk are not exposed to prevention-based intervention. Opportunistic screening in
      hospital Emergency Departments (EDs) tied to behavioral interventions has the potential to
      prevent future alcohol-related harm among young adults, but efficacy across outcomes has been
      mixed and large-scale implementation of prevention programs is low. Given the rapidly growing
      use of cell phone text-messaging (SMS) as a primary form of communication among young adults,
      SMS could be used to deliver health prevention interventions. We will recruit young adults
      identified in the ED with hazardous drinking behavior in a 3-arm randomized controlled trial
      to test the hypothesis that exposure to a 12-week SMS program will result in immediate
      (3-month) and lasting (6-, and 9-month) decreases in alcohol consumption.
    

Intervention name(s): SMS Assessments & Feedback; SMS Assessments
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly pre-weekend drinking plan and post-weekend drinking outcome assessments with personlaized feedback; Weekly post-weekend drinking outcome assessments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: young adults; alcohol consumption; mobile health; text message
Clinical Trial to Evaluate Safety and Efficacy of Hyalospine® in Lumbar Laminectomy or Laminotomy
Condition: Degenerative Spinal Stenosis; Disk Herniation
MeSH terms: Spinal Stenosis; Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this Phase II trial is to evaluate safety and efficacy of Hyalospine in patients
      undergoing lumbar laminectomy or laminotomy for degenerative spinal stenosis or disk
      herniation. The device is used as an adjunct in lumbar spine surgery to prevent post-
      surgical fibrosis and adhesions, and improve patient outcomes.
    


Intervention name(s): Hyalospine
Intervention type(s): Device
Intervention description(s): Intervention group consists of subjects randomized to the treatment arm who will receive lumbar decompression surgery (laminotomy or laminectomy) and HyaloSpine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Influence of a Standardised High Fat Breakfast on the Bioavailability of BI 14332 CL in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the relative bioavailability of BI 14332 CL vs. BI 14332 CL after intake of a
      standardised high fat breakfast
    


Intervention name(s): BI 14332 CL; high fat breakfast
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect on Glycemic Responses and Subjective Ratings of Satiety of a Snack With or Without Ingredients to Slow Carbohydrate Digestion
Condition: Glycemic Response; Satiety
Study type: Interventional

Summary: 
      The objective of this trial is to compare a snack with ingredients (whole grains and dietary
      fiber) to slow carbohydrate digestion to a similar control snack without such ingredients and
      evaluate the effect of the snack on glycemic response and subjective satiety. The test
      product will be compared with a control product as well as white bread in a randomized,
      controlled, crossover trial including 20 healthy males or females between the ages of 18 and
      70 and having a body mass index (BMI) between 25 and 30 kg/m2. Following an overnight fast,
      participants will be given each of the study products in a random order at least a week
      apart. Glucose and insulin will be measured before product consumption and over a period of
      four hours. Visual analog scales to measure subjective satiety will also be administered over
      a period of four hours.
    


Intervention name(s): Nutrient cluster
Intervention type(s): Other
Intervention description(s): Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Bariatric Surgery for the Treatment of Type 2 Diabetes - Clinical Effects and Underlying Mechanisms
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The main purpose of this project is to further explore the metabolic effects and the
      mechanisms underlying the improvement in glucose homeostasis following bariatric surgery. The
      project will involve both prevention and treatment of Type 2 Diabetes (T2D), and both
      pre-diabetic as well as diabetic subjects with obesity will be included. This part of the
      project focuses on patients with manifest T2D and they will be assigned to surgical and
      non-surgical intervention, respectively, in a strictly controlled and randomized manner.
    


Intervention name(s): Laparoscopic Gastric Bypass
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?
Condition: Pain
Study type: Interventional

Summary: 
      Open appendectomy has been used in the treatment of appendicitis, which is among the most
      common emergency pathologies worldwide, since the end of the 19th century. In the 20th
      century, laparoscopic appendectomy came to the fore and the frequency of use increased
      gradually. Despite the frequency of laparoscopic appendectomy, there is no consensus on the
      best way to perform each procedural step. One of these steps is the trocar entry areas. In
      this study, investigator's aim is to compare the trocar entry areas, which are various
      reports in the literature, and to find the localization with the optimal usage area. 140
      patients who underwent laparoscopic appendectomy between 2021-2022 were randomized into four
      groups and included in the study. Demographic data, peroperative findings, complications,
      length of stay and post-operative VAS values of the patients were evaluated.
    


Intervention name(s): Only different trocar sites
Intervention type(s): Procedure
Intervention description(s): Only different trocar sites in literature
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Four trocar tecnıques groups in literature
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopy; Minimally invasive surgery; appendicitis; colorectal
Efficacy, Safety and Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
Condition: Sporadic Inclusion Body Myositis
MeSH terms: Myositis; Myositis, Inclusion Body
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the efficacy, safety and tolerability of BYM338 in patients with
      sporadic Inclusion Body Myositis
    


Intervention name(s): BYM338; Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sporadic Inclusion Body Myositis
Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine
Condition: Diphtheria; Tetanus; Acellular Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Observational

Summary: 
      Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and
      well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare
      outcomes in a large population cohort. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      Data collection through utilization of automated databases at the study site. The
      collaborator is Kaiser Permanente Vaccine Study Center.
    

Intervention name(s): Boostrix®; Td (Tetanus diphtheria) vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Single dose; Single dose
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan
      
Keywords: Boostrix
Psychological Skills Group for Youth of Refugee and Immigrant Backgrounds
Condition: Stress, Psychological; Acculturation Problem
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      There are currently 28 million child refugees worldwide - approximately 1 in every 200
      children on earth. To date, nearly one million forcibly displaced child migrants have been
      resettled in the United States. It is well documented that refugee and immigrant youth,
      especially forcibly displaced ethnic and cultural minority youth, present with alarmingly
      high rates of stress-related psychiatric illness (e.g., PTSD, depression, anxiety) and are
      grossly underserved by current mental health, medical, and social services. Previous research
      found that in a sample of 144 Somali refugee children resettled in the United States, only 8%
      of those who met full clinical criteria for PTSD received any mental health services. Through
      a process of community-based participatory research with refugee and immigrant communities
      and stake-holders the investigators have developed a multi-tiered psychological and systems
      intervention for refugee youth and families, Trauma Systems Therapy for Refugees (TST-R),
      that includes community outreach and advocacy, group psychological treatment, office-based
      psychotherapy, and home-based services.

      Whereas TST-R is one of the only empirically-based behavioral health treatment models for
      refugee youth, it has only been studied as a full intervention model; financial and staffing
      resource barriers have limited the wide-spread adoption of the model. This obstacle noted,
      implementing one high-impact component of this multi-tier intervention (i.e., protocol-driven
      group treatments) may provide significant benefit while also being easily scalable.
      Implementing time-limited (i.e., 10 week) manual-based group psychological interventions
      focused on culturally-responsive strategies to support refugee youth with, and at-risk for,
      PTSD, depression, and anxiety, may be an efficient and cost effective means of (1) reducing
      psychiatric symptoms for refugee and migrant youth with present symptoms, (2) preventing
      symptom onset for those at risk, and (3) enhancing cultural identity self-concept, subjective
      social belongingness, and psychological resilience (e.g., ability to thrive in the context of
      adversity). Furthermore, if effective, treatment groups can importantly function as a
      destigmatizing treatment gateway and triage to other services for youth who require a higher
      level of care (e.g., individual psychotherapy and medication management).
    


Intervention name(s): Trauma Systems Therapy for Refugees Group Intervention
Intervention type(s): Behavioral
Intervention description(s): Psychological skills group for youth of refugee and immigrant backgrounds.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy of a Gluten-free Diet for the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia patients frequently suffer from symptoms similar to those of adult celiac
      disease, raising the possibility that some fibromyalgia patients experience oligosymptomatic
      celiac disease or non-celiac gluten intolerance. The objective of this study is to compare
      the effect of a gluten-free diet with a hypocaloric diet in patients with fibromyalgia and
      celiac-type symptoms.
    

Detailed description: 
      Fibromyalgia, a chronic pain disorder, is characterized by generalized chronic
      musculoskeletal pain that is usually accompanied by several other clinical manifestations
      that contribute to a diminished quality of life, such as sleep disturbances, chronic fatigue,
      mood disorders, and cognitive difficulties. Many patients with fibromyalgia suffer from
      gastrointestinal and extra-intestinal symptoms that are similar to those experienced by adult
      celiac disease patients such as abdominal pain, dyspepsia, nausea, diarrhea, constipation,
      fatigue, pain and mood changes. This raises the possibility that some patients with
      fibromyalgia may also suffer from oligosymptomatic celiac disease or non-celiac gluten
      intolerance. On the other hand, the emerging evidence linking obesity with fibromyalgia and
      the high prevalence of overweight among fibromyalgia patients suggest a potential benefit for
      weight loss among these patients. Thus, the main objective of this study is to compare the
      efficacy of a gluten-free diet (GFD) with a hypocaloric diet (HCD) in patients with
      fibromyalgia that also experience celiac-type symptoms.
    

Intervention name(s): Gluten-free diet; Hypocaloric diet
Intervention type(s): Other; Other
Intervention description(s): A diet that is free of the gluten component; A standard hypocaloric diet with a daily 1500 caloric intake.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fibromyalgia; celiac-type symptoms; gluten-free diet; hypocaloric diet
A Study of the Immunogenicity of Swine-origin A/H1N1 Influenza Vaccine in Healthy Adults
Condition: Influenza; Swine-origin A/H1N1 Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to describe the immunogenicity of a pandemic A/H1N1 influenza vaccine
      in healthy adults given a lower vaccine dose and in a similar group given a full dose of the
      vaccine.

      The primary objective is to describe describe the immune response of the inactivated,
      split-virion swine-origin A/H1N1 influenza vaccine without adjuvant.
    

Detailed description: 
      All participants will receive a single dose of study vaccine and will also be monitored for
      serious adverse events and adverse events of special interest occurring from Days 0 to 21 and
      at 6 months post-vaccination.
    

Intervention name(s): Swine A/H1N1 influenza vaccine (split virion, inactivated); Swine A/H1N1 influenza vaccine (split virion, inactivated)
Intervention type(s): Biological; Biological
Intervention description(s): 0.3 mL, Intramuscular (IM); 0.5 mL, Intramuscular (IM)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Pandemic Flu; Swine-origin Influenza; Inactivated split-virion vaccine
A Multicenter, Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Clinical Efficacy, Safety, and Tolerability of ARX-F01 Sublingual Sufentanil in Patients Undergoing Elective Unilateral Total Knee Replacement
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate three different dosage strengths of sublingual
      ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of
      post-operative pain in subjects following total knee replacement surgery. We hypothesize that
      subjects receiving placebo will have poor pain relief and will drop out of the study sooner
      and more often than the ARX-F01-treated subjects.
    


Intervention name(s): Sufentanil NanoTab; Placebo NanoTab; Sufentanil NanoTab; Sufentanil NanoTab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours; Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours; 10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours; 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours
Other intervention name(s): ARX-F01; ARX-F01; ARX-F01
Intervention MeSH terms: Sufentanil; Dsuvia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Radiofrequency Renal Denervation in Drug Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Single-center, single group study of the efficacy and safety of transcatheter renal
      denervation for treatment of patients with essential hypertension uncontrolled despite
      combined pharmacotherapy including 3 or more hypotensive drugs one of which is a diuretic.
      Bilateral transcatheter renal denervation will be performed on the top of existed
      pharmacotherapy. Change in blood pressure (BP), left ventricle (LV) mass, carotid artery
      thickness, renal artery blood flow and renal function, will be assessed at 6 and 12 months of
      follow-up.
    


Intervention name(s): Bilateral radiofrequency sympathetic renal denervation
Intervention type(s): Procedure
Intervention description(s): Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways
Other intervention name(s): Transcatheter renal denervation; Percutaneous radiofrequency ablation of renal nerves
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Radiofrequency Catheter Ablation; Renal Artery; Sympathetic Nerve Block
Antioxidants Vitamins and Muscle Damage
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      Determine if acute supplementation with antioxidant vitamins (vitamin C and vitamin E)
      influences the muscle damage and fatigue caused after an acute session of eccentric training.
    

Detailed description: 
      A randomized, single-blind, placebo-control parallel trial will be conducted. In a previous
      session volunteers will be interviewed to determine if they meet the inclusion criteria.

      Participants should avoid ingesting of foods that contain high amounts of antioxidant
      compounds: more than two juices of fruits, more than four cups of coffee or tea. Juices with
      high antioxidant content should be avoided. Alcoholic beverages should also be avoided.
      Participants will be divided in to groups and will performance one resistance exercise
      sessions. Prior to exercise, one group will intake supplementation VitC (1000 mg) + VitE (235
      mg) and the other supplementation with placebo.

      The following sequence will be performed in each session: 1) baseline assessment (analysis of
      the composition body, blood draw and parameters of performance) prior to exercise session ;
      2) administration of vitamin or placebo supplementation 2 hours before exercise session ; 3)
      post-exercise assessments (blood biomarkers and performance parameters) immediately after the
      session and after 24 hours. DOMS will also be assessed 48 h and 72 h after training. The
      training session implemented will be designed by a Sport Scientific
    

Intervention name(s): Dietary Supplement: Vitamin C and vitamin E; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Antioxidant supplementation; Placebo administration
Other intervention name(s): Ascorbic acid and tocopherol
Intervention MeSH terms: Vitamins; Ascorbic Acid; Vitamin E; Tocopherols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: antioxidant vitamins; oxidative damage
Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether SLx-4090 in combination with statin therapy
      will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.
    

Detailed description: 
      1. LDL-C after 12 weeks of treatment

        2. Safety and tolerability

        3. Plasma levels of SLx-4090
    

Intervention name(s): SLx-4090; SLx-4090; Placebo; Statin
Intervention type(s): Drug; Drug; Other; Drug
Intervention description(s): tablet; tablet; matching tablet; Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment