bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Musculoskeletal Injuries in Slovenian Armed Forces
Condition: Knee Injuries and Disorders; Ankle Injuries and Disorders; Low Back Pain
MeSH terms: Low Back Pain; Wounds and Injuries; Knee Injuries; Ankle Injuries
Study type: Interventional

Summary: 
      Physical readiness of military personnel is a cornerstone of any army, as soldiers are
      expected to meet high physical demands on a daily basis, and soldiers must complete one hour
      of physical conditioning each day. Participation in physical conditioning increases the risk
      of musculoskeletal injuries, and our 10-year retrospective analysis shows that 5% of soldiers
      sustain a sports injury during physical conditioning each year, and that ankle and knee
      injuries have the highest incidence rates of 25% and 20%, respectively. The primary objective
      of our study is to decrease the rate of ankle and knee injuries by implementing a preventive
      training program. The study is designed as a prospective randomized controlled trial with two
      arms (experimental and control).
    

Detailed description: 
      Members of Slovenian Armed Forces - SAF (age range 18-51 years) are expected to participate
      in the study. Prior to recruitment the whole project will be explained to soldiers in a form
      of briefing during which they have the opportunity to ask and have answers to any questions
      concerning the nature of subsequent research. Following that explanation each participant
      will sign a consent form to voluntarily participate. No compensation will be given or
      promised for participation in a study that was approved by the Ethical board of the Faculty
      of Sport in Ljubljana (No. 454/2017). At the time of testing all soldiers must be free of
      acute injuries and should not reported any pain in musculo-skeletal system. Prior to the
      implementation of the preventive program all participants will underwent the set of
      functional testing that includes counterMovement jump (CMJ) testing, stork balANce test,
      pUll-ups, single leg hAmstrings bridge test, and loaded prone pLank test - MANUAL. Following
      initial testing a 15-week preventive training program will be implemented in experimental
      group, while control group will be training as usual. Following the intervention final
      testing will be performed to check for effectiveness of the intervention. After that a
      follow-up period will start during which injuries will be registered in both groups and later
      compared between groups (control and experimental) and within (2016-2017 injuries) groups to
      see if incidence rate of ankle and knee injuries has fallen.
    

Intervention name(s): Exercise
Intervention type(s): Other
Intervention description(s): neuromuscular training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosed of HSK31858 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single-dose escalation clinical trial for HSK31858 conducted in healthy
      volunteers. The safety, tolerability, and pharmacokinetics of HSK31858 tablet in healthy
      volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial
      design.
    


Intervention name(s): HSK31858, tablet; Placebo, tablet
Intervention type(s): Drug; Drug
Intervention description(s): Starting dose in single ascending dose: 5 mg; Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: HSK31858; NCFBE; health; phase I
Phase 4 Study in the Elderly Patients With T2DM
Condition: Type 2 Diabetes Mellitus; Elderly
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will assess the incidence of Hypoglycemia: Percent of patients presenting no
      hypoglycemia (confirmed events with SMBG and severe episodes) over 6 months follow up in T2DM
      patients treated with a DPP-4 inhibitor or another OAD as add-on therapy to metformin
    


Intervention name(s): Vildagliptin; "Usual Care"
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus, vildagliptin, hypoglycemia, elderly
Cephalic Version by Acupuncture-Moxibustion for Breech Presentation
Condition: Breech Presentation
MeSH terms: Breech Presentation
Study type: Interventional

Summary: 
      For breech presentation, the cesarean section rate is decreased by external cephalic version.
      This is a painful operation, with some rare but serious complications. The aim of this trial
      is to evaluate the effectiveness of acupuncture-moxibustion, a non-invasive technique, to
      correct breech presentation before 37 weeks of gestation.
    

Detailed description: 
      Monocentric controlled randomized trial in a simple blind fashion, comparing
      acupuncture-moxibustion versus a placebo in singleton pregnancies with breech presentation
      between 33+5 to 35+5 weeks of gestation. The intervention arm consists of
      acupuncture-moxibustion at the BL67 acupuncture point, for six seances of twenty minutes two
      days apart. In the placebo group, the cold light of an inactivated laser is to be applied in
      the same point during the same time. When cephalic version fail, a manual external cephalic
      version is to be proposed. The main outcome measure is cephalic presentation at 37+2 weeks of
      gestation.
    

Intervention name(s): Acupuncture moxibustion; Placebo
Intervention type(s): Other; Other
Intervention description(s): Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.; Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart
Other intervention name(s): no applicable; no applicable
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: pregnancy; breech; acupuncture; moxibustion; version
Identification of Biomarkers for Early Detection of Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help
      doctors learn more about changes that may occur in DNA and identify biomarkers related to
      cancer.

      PURPOSE: This laboratory study is examining blood samples from patients with cancer to
      identify biomarkers that may help in the early detection of pancreatic cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Identify specific proteins of interest to evaluate for their potential role as markers
           for pancreatic cancer.

        -  Analyze serum proteins directly by mass spectrometry to identify new biomarkers of
           pancreatic cancer that can be used for early diagnosis.

      OUTLINE: Blood from patients is collected prior to treatment. Plasma proteins are analyzed by
      matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF/MS)
      and/or electrospray mass spectrometry (ESI/MS).

      PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.
    

Intervention name(s): protein expression analysis; laboratory biomarker analysis; mass spectrometry; surface-enhanced laser desorption/ionization-time of flight mass spectrometry
Intervention type(s): Genetic; Other; Other; Other
Intervention description(s): Venous blood collection; Venous blood collection; Venous blood collection; Venous blood collection
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Venous blood collection samples from newly dianosed
      
Biospecimen description: 
      Venous blood
    
Keywords: stage I pancreatic cancer; stage II pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer
Impact of Non Invasive Ventilation on Quality of Sleep
Condition: Restrictive Pulmonary Disorders; Non Invasive Ventilation
MeSH terms: Lung Diseases
Study type: Observational

Summary: 
      Quality of sleep is profoundly affected in patients with hypercapnic respiratory failure and
      restrictive disorders, with a decrease in rapid eye movement (REM) and slow wave sleep, and
      an increase in sleep fragmentation. Assisted ventilation aims at improving blood gases, but
      may also have a favorable impact on sleep structure. The investigators reviewed
      polysomnographic and blood gas data obtained between 1987 and 2008 in 95 patients with
      restrictive pulmonary disorders, before and after implementing non-invasive ventilatory
      support.
    

Detailed description: 
      Chart review of all patients with predominantly restrictive pulmonary disorders treated for
      respiratory failure by NIV at our institution between 1987 and 2008.

      Data systematically recorded included pulmonary function tests, diurnal arterial blood gases,
      and polysomnography before and after implementation of nocturnal NIV.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with respiratory failure due to predominantly restrictive disorders submitted to
        NIV in preparation for long-term home ventilation and assessed between 1987 and 2008 at the
        Sleep laboratory.
Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy
Condition: Anxiety Disorders; Major Depression; Stress Disorders; Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders; Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily from
      mental health disorders, such as anxiety disorders and depression. Cognitive behavior therapy
      (CBT) has been shown to be an effective treatment of these disorders. Despite the strong
      evidence for CBT there is a lack of evidence-based psychological treatment in primary care.
      For various reasons, the progress of research has not affected clinical practice. For
      successful implementation of CBT in primary care cost-effective therapies, access to
      therapists with proper training and supervision, evidence-based manuals and management that
      support the implementation is needed.

      Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All
      patients are first treated with self-help CBT (N = 400). Patients that do not improve after
      treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based
      on published studies 2/3 is expected to be improved after self-help and therefore do not
      undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to
      individual CBT (N = 67) or continued self-help treatment (N = 67).
    


Intervention name(s): Continued self help CBT; Individual CBT
Intervention type(s): Behavioral; Behavioral
Intervention description(s): After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.; After the initial face of self help CBT, patients in this arm receive individual CBT. The cognitive behavior therapy used in the study will be based on the protocols with best empirical support.The therapy is delivered by the same psychologist as in the first face and the second face builds on the learning's from the first face.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
New Therapeutical Perspectives in Cases of Phonological Disorders
Condition: Speech Sound Disorders
MeSH terms: Articulation Disorders; Speech Sound Disorder
Study type: Interventional

Summary: 
      The aim of this study is to verify phonological and auditory aspects of children submitted to
      traditional phonological therapy, phonological therapy using a software and placebo therapy
      in children with phonological disorders.
    

Detailed description: 
      The study will provide different therapeutic approaches for cases of phonological disorders,
      the classical approach would be mediated by Cycles Model, innovated approach is performed by
      means of an intervention speech software-SIFALA, there will still be the group that does not
      receive any of the proposals therapies that will be the placebo group.The study will provide
      25 sessions for each group, with 30 minutes in each group. At the end of these sessions, the
      placebo group will receive one of the therapeutic approaches. With these three study groups,
      the investigators understand in what manner to obtain correct sounds is more effective.
    

Intervention name(s): Traditional Phonological Therapy; Software Phonological Therapy- SIFALA; Placebo Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words.; The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds.; No intervention to improve speech.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Speech; Speech Therapy; Speech Sound Disorders; Phonological Disorders; Auditory Perception
Biology and Experience of Eating in Women With Obesity
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to understand how the opioid system is involved in eating
      behavior.
    

Detailed description: 
      Obesity is associated with greater risk for cardiovascular disease (CVD), stroke, diabetes,
      and mortality, and is a heterogeneous condition with various causes and thus a diversity of
      intervention targets. Compulsive overeating afflicts 30% of people seeking obesity treatment
      and increases risk for CVD factors. This trial involves two participant visits to test
      whether opioid blockade (Day 1 or 2, depending on randomization), compared to placebo (Day 1
      or 2, depending on randomization), will elicit common symptoms of opioid withdrawal,
      including nausea. Participants will receive each condition on separate days.
    

Intervention name(s): Naloxone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 4 mg / 0.1 ml; 0.1 ml
Other intervention name(s): Narcan; saline
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Obesity; Binge eating
Relative Bioavailability and Food Effect Study With Vericiguat to Characterize the Pediatric Formulation in Adult Healthy Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Vericiguat is intended to be used for the treatment of cardiovascular diseases, especially
      heart failure. Heart failure also occurs in children. Therefore, a study testing vericiguat
      in the treatment of heart failure in paediatric patients is planned under the paediatric
      investigational plan (PIP). In order to administer vericiguat to children, a vericiguat
      paediatric formulation is needed. This paediatric formulation is characterized in this study
      prior to its use in paediatric patients.
    


Intervention name(s): Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed; Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted; Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed; Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast; Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast; Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Vericiguat high-dose pediatric formulation (fed; American breakfast), 10 mg given as 20 x 0.5 mg mini tablets; Vericiguat high-dose pediatric formulation (fasted),10 mg given as 20 x 0.5 mg mini tablets; Vericiguat low-dose pediatric-formulation (fed; American breakfast), 2.5 mg given as 25 x 0.1 mg mini tablets; 10 mg IR tablet, intact (fed; American breakfast); 10 mg IR tablet, crushed (fed; American breakfast); 10 mg IR tablet, intact (fed; Continental breakfast)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Trial of a Novel Family-Based Intervention to Increase Outdoor Time and Fitness
Condition: Myopia; Obesity
MeSH terms: Myopia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to implement a new family-based health behavior community program to increase
      time spent outdoors and physical activity among Singapore children aged 6 to 12 years in a
      1-year randomized clinical trial. 300 children from 250 families will be randomly assigned to
      either a family-based intervention or no intervention. The family-based intervention
      comprises structured weekend outdoor activities organized by National Parks and incentives
      for children to wear a pedometer and increase their daily steps. Families who meet their
      monthly step and outdoor activity goals will receive a range of prizes and incentives. Both
      groups will receive brochures on the National Myopia Prevention Program and physical
      activity. The success of the intervention will be evaluated through light meters, 7-day
      outdoor diaries, questionnaires documenting outdoor time and myopia; as well as pedometer
      steps, walking tests, and body mass index. A community-based intervention will be developed
      to improve the health of Singapore children by increasing outdoor time and physical activity
      to prevent myopia and obesity.
    

Detailed description: 
      To develop, implement, and evaluate a novel incentive-based family intervention to increase
      time spent outdoors and physical activity among children aged 6 to 12 years in a 1-year
      randomized controlled trial.
    

Intervention name(s): Family-based Outdoor program
Intervention type(s): Behavioral
Intervention description(s): 2 to 3 hour outdoor activities organized in conjunction with National Parks, Singapore
Other intervention name(s): Outdoor intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Myopia; Outdoor activity; Physical activity; Randomized Controlled Trial; Pedometer; Behavior modification; Obesity
GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
Condition: Type 2 Diabetes Mellitus; Overweight and Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight
Study type: Interventional

Summary: 
      The primary aim of the study is to evaluate how GIP receptor activation influence food intake
      and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in
      steady treatment with metformin and a GLP-1 receptor agonist.
    

Detailed description: 
      The study is designed as a double blinded cross-over study with two study days: One day of
      GIP infusion (for 5 hours) and one day with placebo (saline) infusion (for 5 hours). The
      primary endpoint is difference in food intake between the two study days. Food intake is
      examined as amount of food eaten during an ad libitum meal.
    

Intervention name(s): GIP1-42 infusion; Saline
Intervention type(s): Biological; Other
Intervention description(s): 5-hour GIP1-42 infusion (time point 0-300 minutes); 5-hour infusion of saline (placebo) (time point 0-300 minutes)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Resistance Versus Balance Training in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Comparison of resistance training versus balance training to improve postural control in
      patients with Parkinson's Disease
    


Intervention name(s): Resistance Training; Balance Training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Single DermaVir Immunization in HIV-1 Infected Patients on HAART
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      -  DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered
           topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir
           migrate to lymph nodes and express HIV-like particles that induce immune responses to
           kill HIV-infected cells.

        -  Hypothesis: Single DermaVir immunization is safe and immunogenic measured by induction
           of HIV-specific precursor/memory T cell responses.

        -  GIHU004 was a phase I dose escalation study conducted in Hungary. It evaluated the
           safety and immunogenicity of three dosing regimens of topical DermaVir immunization for
           the treatment of HIV-infected individuals on fully suppressive highly active
           antiretroviral therapy (HAART).
    

Detailed description: 
      This study enrolled nine HIV-infected adult subjects in three sequential dose cohorts. All
      had durable suppression of HIV-RNA on HAART over the previous 6 months and CD4 count over 300
      cells/mm3. Subjects, received on study Day 0 a single DermaVir immunization:

        -  Low dose: 0.1 mg pDNA, 0.8 mL DermaVir administered under two DermaPrep patches.

        -  Medium dose: 0.4 mg pDNA, 3.2 mL DermaVir administered under four DermaPrep patches.

        -  High dose: 0.8 mg pDNA, 6.4 mL DermaVir administered under eight DermaPrep patches.

      Subjects were on study for a total of 28 days followed by a post-treatment safety follow-up
      for 48 weeks. HAART was not interrupted. All subjects completed the 28-day treatment and 48
      weeks safety follow up phase.
    

Intervention name(s): DermaVir; HAART
Intervention type(s): Biological; Drug
Intervention description(s): DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with DermaPrep medical device. These DermaVir-containing Langerhans cells migrate to the lymph nodes, where induce HIV-specific cytotoxic T cells that can recognize and kill HIV-infected cells.; Three or more antiretroviral drugs that can fully suppress HIV RNA
Other intervention name(s): LC002; Highly active antiretroviral therapy
Intervention MeSH terms: Anti-Retroviral Agents
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Vaccine; Immune Therapy; DermaVir