bioihbjkbjnl/mcl2 huggingface dataset:
A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease
Condition: Diabetes Mellitus, Type 2; Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of
      the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A
      in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic
      fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled
      across multiple sites in the United States. Participants will be randomly assigned to receive
      study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to
      8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to
      clinic for an optional pre-screening visit.
    


Intervention name(s): BFKB8488A; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Administered subcutaneously starting on Day 1 and according to dosing schedule.; Administered subcutaneously starting on Day 1 and according to dosing schedule.
Other intervention name(s): RO7040551
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Continuous Positive Airway Pressure (CPAP) for Preventing Respiratory Failure After Laparoscopic Radical Prostatectomy
Condition: Continuous Positive Airway Pressure [E02.041.625.790.259]; Prostatectomy [E04.950.774.860.625]; Laparoscopy [E01.370.388.250.520]; Pneumoperitoneum [C06.844.670]
MeSH terms: Pneumoperitoneum
Study type: Interventional

Summary: 
      Aim of this study is verify if postoperative CPAP after laparoscopic prostatectomy may reduce
      the impact of postoperative respiratory failure, defined as occurrence of hypoxemia (PaO2<60
      mmHg) and/or reduction of Forced Expiratory Volume in 1 second (FEV1) beyond 70% of basal
      value.
    

Detailed description: 
      Laparoscopic radical prostatectomy (LRP) is a wide used, well tolerated procedure. However,
      the general anesthesia, the need for pneumoperitoneum and Trendelenburg position may have
      detrimental effects on both pulmonary volumes and mechanics, and they may increase the risk
      of postoperative respiratory failure (PORF). Continuous positive airway pressure (CPAP)
      improves oxygenation and reduces the rate of re-intubation in the presence of PORF.

      The aim of our study is to investigate postoperative respiratory function and the likely
      benefits of the use of CPAP, compared with Venturi mask in terms of prevention of
      post-operative hypoxaemia and worsening of lung spirometry.

      CPAP is delivered with "CASTAR" Helmet by StarMed.
    

Intervention name(s): Continuous Positive Airway Pressure(CPAP); Venturi Mask FiO2 40%
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Burn Scar Appearance After Treatment With Fractional Carbon Dioxide (CO2) Laser
Condition: Scars
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      The purpose of this study is to determine if fractional carbon dioxide laser treatment of a
      burn scar is a more effective method for improving the appearance of scars than the current
      available treatments.
    


Intervention name(s): Lumenis fractional carbon dioxide laser
Intervention type(s): Device
Intervention description(s): Laser resurfacing of a burn scar
Other intervention name(s): Lumenis
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: burn scar; fractional carbon dioxide laser; scar revision
Effect of Oral Vitamin D Supplement on Atopic Dermatitis; A Clinical Trial With Staphylococcus Aureus Colonization Determination
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

Summary: 
      Background: Increase in skin colonization of Staphylococcus aureus (S. aureus) in atopic
      dermatitis patients (AD) resulted from the reduction of cathelicidin production in these
      patients plays the important role in pathogenesis of this disease. Recently in vivo study has
      showed that vitamin D can stimulate cathelicidin production. Oral supplement of vitamin D
      might be beneficial in atopic dermatitis.

      Objective: To determine the effect of oral vitamin D supplement on clinical impact including
      skin colonization of S. aureus in atopic dermatitis patients.
    


Intervention name(s): oral vitamin D; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Atopic dermatitis, vitamin D supplementation, cathelicidin, Staphylococcus aureus colonization, SCORAD score
Dose Effect of Limicol on (LDL)-Cholesterol Levels
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The principal objective of this study is to investigate the dose-effect of the Limicol food
      supplement on LDL-cholesterol level in moderate hypercholesterolaemia subjects.
    


Intervention name(s): Limicol; Limicol; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment; 6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment; 6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Cholesterol; LDL-cholesterol; Coronary artery disease; Red yeast rice; Plants extract; Cholesterol excess; Delivery of Health Care
Effect of Functional Relaxation on Patients Undergoing Colonoscopy
Condition: Colonoscopy; Relaxation
Study type: Interventional

Summary: 
      Patient attending for colonoscopy are generally worried and anxious. Fear of discomfort is
      the most common reason for low acceptance of colonoscopy. Several methods have been used to
      minimize patient discomfort, including the use of paediatric colonoscopes, variable stiffness
      colonoscopes, gastroscopes, music, audio distraction, or simply allowing the patients to
      participate in administration of medication. Although a potential benefit from some of these
      methods has been suggested, no clear recommendations have been made so far. We hypothesized
      functional relaxation reduces discomfort during colonoscopy.
    


Intervention name(s): Functional relaxation; No relaxation
Intervention type(s): Procedure; Procedure
Intervention description(s): Functional relaxation during colonoscopy; No relaxation during colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
HMGB1 in ICU-survivors
Condition: Sepsis; Cognitive Impairment
MeSH terms: Sepsis; Cognitive Dysfunction
Study type: Observational

Summary: 
      Is HMGB1 (High Mobility Group Box 1) elevated in sepsis patients for weeks after recovery
      from severe sepsis/septic shock, similar to what has been observed in mice? Do patients
      recovering from severe sepsis/septic shock suffer from cognitive impairment and is such
      impairment associated with prolonged HMGB1 levels in plasma? Is there a difference from
      patients recovering from critical illness without prior sepsis?
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients being treated at Karolinska University Hospital Intensive Care Unit
      
Biospecimen description: 
      Plasma
Effects of Active Video Games in Physically Inactive Children
Condition: Self-Perception; Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      Inactivity was reported to be high in children and considered to be the fourth common cause
      of death in all ages. The reason for children is usually the increasing indoor use of
      sedentary screen time. Active Video Games (AVG) have recently been introduced for decreasing
      the sedentary time for children and directing them to physical activity (PA) at home.The aim
      of this study is to show the quantitative effect of games on physical fitness parameters like
      weight, body mass index (BMI) and fat ratio (FR). The study also aims at the factors for
      motivation or continuance of the games as self-perception and enjoyment levels together with
      qualitative effects of games on satisfaction and attitude changes in inactive children.
    

Detailed description: 
      Research related a causal association between inactivity, low esteem, and excess weight for
      children. For this reason, academic performance decreases and obesity associated diseases
      such as hypertension, diabetes, coronary heart diseases, depression, and cancer might ensue.
      Children usually do not prefer to perform outdoor PA due to several causes including low
      sense of self perception.

      So far studies have shown an almost equivalent energy spent through AVGs to the physical
      activity of moderate intensity. Games have been previously demonstrated to prevent excess
      weight. There were no studies of AVG in children with varying weights, inactivity and
      technology preoccupation. Similarly, no qualitative research of AVG in children exploring
      enjoyment levels and attitude changes were encountered.

      Thus, the investigators aim to find the quantitative effect of AVG on physical fitness
      parameters like weight, BMI and FR. Other aims are studying factors for motivation or
      continuance of the games as well as the feelings and perspectives of the participant
      children's parents for the games.
    

Intervention name(s): Active Video Games
Intervention type(s): Other
Intervention description(s): Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: inactive children; active video games; physical fitness; self-perception; enjoyment; obesity
The Effects of Kinesio Tape Application With Different Verbal Input Given to With Patients With Rotator Cuff Tear
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Interventional

Summary: 
      The aim of the study to investigate the effectiveness KT application with different verbal
      inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear.
    

Detailed description: 
      Rotator cuff tears are most common of shoulder pain and functional limitations. Kinesio tape
      (KT) are frequently used in the conservative treatment of shoulder pathology. Even if some
      studies showed that KT is effective on pain, we think that it is due to positive thoughts of
      the patients about KT. The aim of the study to investigate the effectiveness KT application
      with different verbal inputs on pain, function and range of motion (ROM) on patient with
      rotator cuff tear. 97 patients (Group 1, n=32; Group 2, n=33, Group 3, n=32) were randomized
      into 3 groups according to verbal input given to patients about the effectiveness of KT;
      Group 1 (it has been limited evidence of KT is effective), Group 2 (it has been not known
      that KT is effective or not), Group 3 (it has been known that KT has excellent result). The
      same standard KT was applied to 3 groups. The rest, night and pain in activity were assessed
      by Visual Analog Pain Scale (VAS) before, after 30 min and 24 hours after KT application. ROM
      assessed by goniometer and the function was evaluated by Disabilities of the Arm, Shoulder
      and Hand (DASH) and the American Shoulder and Elbow Surgery score (ASES) before and 24 hours
      of KT application. Minimal clinically important difference and effective were calculated for
      the assessments used in the study.
    

Intervention name(s): Negative Verbal Input; Neutral Verbal Input; Positive Verbal Input
Intervention type(s): Other; Other; Other
Intervention description(s): The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been limited evidence of KT is effective during application.; The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been not known that KT is effective or not during application.; The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been known that KT has excellent result during application.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: shoulder pain; shoulder function
Project SOLVE: Trial of a Brief Digital Problem-solving Intervention
Condition: Anxiety; Depression; Stress
MeSH terms: Depression
Study type: Interventional

Summary: 
      The goal of this trial is to examine the effectiveness of a universal, self-guided, digital
      single-session intervention focusing on problem-solving skills in improving adolescent mental
      health and well-being, relative to an active control intervention focusing on study skills,
      within the context of school settings during the coronavirus disease pandemic.
    

Detailed description: 
      More than 20% of adolescents will experience at least one mental health disorder or problem
      before adulthood that warrants treatment, yet 80% of these adolescents will never receive
      care. This need-to-access gap appears to be heightened during the current coronavirus disease
      pandemic and its resulting disruptions to healthcare and education systems. Both within and
      beyond the context of the pandemic, preventive mental health interventions are positioned to
      help adolescents build and strengthen coping strategies that can preclude the emergence of
      mental health difficulties that require more resource-intensive levels of clinical care.
      Preventive mental health interventions delivered via digital platforms and within
      school-based settings might be especially scalable.

      The current school-based trial is designed to test one such strategy that harnesses
      technology to boost the scalability of adolescent mental health interventions: a brief (one
      30 minute session) digital program designed to empower adolescents (10-14 years old) to
      solve, rather than be overwhelmed by, everyday problems (Project SOLVE). Single-session
      interventions designed to help adolescents cultivate adaptive mindsets have reduced anxiety
      and depression among adolescents with and without elevated symptoms of these disorders.
      Building on this strong foundation, Project SOLVE targets these mental health challenges with
      problem solving skills-one of the most versatile, commonly used, and potent therapeutic
      techniques for adolescents.
    

Intervention name(s): Project SOLVE; Project SUCCESS
Intervention type(s): Other; Other
Intervention description(s): This 30-minute, self-guided, digital program is designed to help adolescents solve, rather than be overwhelmed by, everyday problems.; This 30-minute, self-guided, digital program is designed to help adolescents develop study skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants (anticipated N = 1,000), ages 10-14 years old, will be randomized to complete one of two 30-minute, digital programs: (1) Project SOLVE: a program designed to teach adolescents how to solve, rather than be overwhelmed by, everyday problems; or (2) Project SUCCESS: a control program designed to teach adolescents helpful study skills.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Postural Analysis of Patients Receiving Rehabilitation Program
Condition: Stability
Study type: Observational

Summary: 
      This is a study for evaluation of posture of patients with neurological disease in
      rehabilitation department.
    

Detailed description: 
      In this study, we evaluate the static posture stability of the patient, such as during
      sitting, standing and dynamic posture stability of the patient, such as during walking,
      time-up-and-go test.
    

Intervention name(s): Ankle foot orthosis
Intervention type(s): Device
Intervention description(s): We evaluate the difference of with or without ankle foot orthosis
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient with physical disability followed-up in rehabilitation department
Dosing of Tenofovir and Efavirenz in Antiretroviral Therapy
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Tenofovir+lamivudine+efavirenz is still the first line regimen of combination antiretroviral
      therapy in developing countries. Based on our previous data, we aim to evaluate whether
      reduce the dose of tenofovir and efavirenz could decreasing the incidence of the side effects
      while not scarifying their virological efficacy.
    


Intervention name(s): Tenofovir; Lamivudine; Efavirenz
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tenofovir Disoproxil Fumarate; Lamivudine; Efavirenz
Intervention MeSH terms: Tenofovir; Lamivudine; Efavirenz
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study will compare the effect of three transcranial photobiomodulation (t-PBM) doses
      (high, middle, and low irradiance) to sham t-PBM on PFC CBF as assessed with fMRI (BOLD) in
      this multi-center, phase I, double-blinded, dose-ranging, controlled, crossover study of 30
      subjects with MDD. All eligible participants will undergo four sessions of t-PBM during fMRI
      so that they experience irradiances of 50, 300 and 700 mW/cm2 as well as sham. The order of
      dose administration will be randomized and t-PBM will be administered with the LightForce®
      EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0).
    

Detailed description: 
      The purpose of this research study is to determine if application of near infrared energy to
      the forehead can change blood flow in the brains of people with depression. Near infrared
      energy is like light but is not visible to the human eye. This research study will compare
      near infrared exposure with a placebo or sham procedure. The sham procedure will look and
      feel just like the near infrared procedure but won't include near infrared exposure.
    

Intervention name(s): Transcranial Photobiomodulator; Sham
Intervention type(s): Device; Device
Intervention description(s): Delivers laser-generated Near-Infrared Radiation (NIR) to forehead at 3 doses of irradiance - High (770 mW/cm2), Middle (300 mW/cm2), and Low (50 mW/cm2).; Transcranial Photobiomodulator delivers sham irradiance dose of 0 mW/cm2.
Other intervention name(s): LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: MDD, neuromodulation, transcranial photobiomodulation
Influence of Bupropion on the Effects of MDMA
Condition: Healthy; Substance-related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determinate the effect of a pre-treatment with bupropion, a
      dopamine and norepinephrine transporter inhibitor, on the pharmacodynamics and
      pharmacokinetics of 3,4-methylenedioxymethamphetamine (MDMA, "Ecstasy"). The study will
      provide further understanding of the dopaminergic regulation of mood.
    

Detailed description: 
      3,4-methylenedioxymethamphetamine (MDMA, "ecstasy") is widely used by young people for its
      euphoric effects. MDMA releases serotonin (5-HT), dopamine (DA), and norepinephrine (NE).
      5-HT release mainly contributes to the subjective effects of MDMA whereas NE release is
      involved in the cardiovascular and psychostimulant effects of MDMA. DA mediates the
      reinforcing addiction-related effects of drugs of abuse but it is unclear whether DA
      contributes to the acute effects of MDMA in humans. To determine the role of DA
      transporter-mediated DA release in the acute response to MDMA in humans the investigators
      test the effects of the DA transporter inhibitor bupropion on the physiological and
      subjective effects of MDMA. The investigators use a randomized double-blind
      placebo-controlled cross-over design with four experimental sessions. Bupropion or placebo
      will be administered before MDMA or placebo to 16 healthy volunteers. Subjective and
      cardiovascular responses will be repeatedly assessed throughout the experiments and plasma
      samples are collected for pharmacokinetics. The primary hypothesis is that bupropion reduces
      the MDMA-induced increase in positive mood.
    

Intervention name(s): MDMA; Bupropion; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg per os, single dose; Bupropion will be administered in a dose of 150mg (Wellbutrin XR) once-daily in the morning for three days followed by 300mg (2x150mg) for 4 days before the test day. On the test day, a final dose of 300mg will administered 2 hours before the administration of MDMA 125 mg or placebo.; per os
Other intervention name(s): Ecstasy; 3,4-Methylenedioxymethamphetamine; Wellbutrin XR; Zyban; capsules containing manitol looking identical to MDMA or bupropion
Intervention MeSH terms: Bupropion; N-Methyl-3,4-methylenedioxyamphetamine
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: MDMA; pharmacokinetics; pharmacodynamics; emotions; Mechanism of action of MDMA; Interaction study; Effect of MDMA and bupropion on emotions
Efficacy of Probiotics on Excessive Gas Accumulation
Condition: Flatulence; Bloating
MeSH terms: Flatulence
Study type: Interventional

Summary: 
      Efficacy of probiotics on excessive gas accumulation
    


Intervention name(s): Probiotic supplement; Placebo supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic supplement; Placebo supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention