bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Protein-enriched Diet on Body Composition and Appetite
Condition: Overweight; Obese; Metabolic Syndrome; Non Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Overweight; Metabolic Syndrome
Study type: Interventional

Summary: 
      Obesity is a major problem worldwide and current dietary interventions are not proving to be
      enough to cease the increase in levels of obesity and its detrimental side effects, such as
      nonalcoholic fatty liver disease (NAFLD).

      Existing data suggests that adjustments in the macronutrient composition of the diet, more
      specifically the protein content, may have beneficial effects on body composition and an
      antiobesegenic effect on appetite. This may be important in terms of controlling body weight
      and reducing the amount of fatty tissue within our bodies and organs, and therefore
      preventing obesity and its health related side effects.

      The investigators will perform a study to investigate whether a high protein low energy diet
      compared to a normal protein low energy diet, in overweight adults can modify appetite and
      aid loss of weight and fat mass. Subjects will receive either a high protein low energy diet
      (1.34g protein/kg body weight) or a normal protein low energy diet (0.8g protein/kg body
      weight) in the form of 2 meal replacements and one conventional meal per day with 2 snacks
      for 12 weeks.

      HYPOTHESIS In overweight subjects with the metabolic syndrome, a 12 week dietary intervention
      with a high protein low energy diet will lead to a reduced appetite, body weight and fat
      mass, more specifically to a greater fall in levels of fat in the liver and pancreas than a
      low energy normal protein diet.
    


Intervention name(s): High Protein, low calorie meal replacement
Intervention type(s): Dietary Supplement
Intervention description(s): The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: high protein diet; meal replacements; low calorie diet; intra hepatocellular lipid
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
Condition: Intracranial Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the Low Profile
      Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc. when used
      to facilitate endovascular coiling of wide-necked intracranial aneurysms with coils.
    


Intervention name(s): LVIS™ and LVIS™ Jr
Intervention type(s): Device
Intervention description(s): The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
Other intervention name(s): Low Profile Visualized Intraluminal Support device
Intervention model: Single Group Assignment
Intervention model description: Low Profile Visualized Intraluminal Support device
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intracranial, saccular, aneurysms, stenting, coiling
The Effect of Schumann Resonance on Preterm Newborns
Condition: Extremely Low Birth Weight
MeSH terms: Birth Weight
Study type: Interventional

Summary: 
      Body weight gain is crucial for preterm newborns, especially those with a low birth weight.
      Owing to their noninvasive, noncontact, and non-pharmaceutical properties, extremely low
      frequency electromagnetic fields (ELF-EMFs) are a promising medium of alternative and
      complementary therapy.
    

Detailed description: 
      Sixty-one preterm newborns of 32-35 weeks' gestational age were recruited from the neonatal
      intensive care unit of the Chung Shan Medical University Hospital and randomly assigned to
      one of two groups: the experimental group (n = 31) or the control group (n = 30). Both groups
      received the same medical care, but the experimental group was exposed to ELF-EMFs until
      discharge.
    

Intervention name(s): extremely low frequency electromagnetic fields; routine care
Intervention type(s): Device; Other
Intervention description(s): extremely low frequency electromagnetic fields; routine care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
LISA-study : Levothyroxin in Nodular Goiter
Condition: Goiter, Nodular
MeSH terms: Goiter; Goiter, Nodular
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:

        -  To evaluate change in total volume of all nodules.

      Secondary objectives:

        -  To evaluate change in goiter volume after a 12-months treatment, number of nodules and
           echogenicity of nodules.
    


Intervention name(s): Levothyroxin-Na; Levothyroxine-Na + iodide; Iodide; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet 30 minutes before breakfast; 1 tablet 30 minutes before breakfast; 1 tablet 30 minutes before breakfast; 1 tablet 30 minutes before breakfast
Intervention MeSH terms: Iodine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Anatomic Altas of the Whole Human Body
Condition: Healthy Volunteer
Study type: Observational

Summary: 
      The goal is the constitution of a statistical atlas of the human being morphology
      variability.

      This work would be a significant step forward in the field of anatomy and biomechanical
      simulation.
    


Intervention name(s): Healthy volunteers
Intervention type(s): Other
Intervention description(s): MRI scanner
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers adults.
      
Keywords: Atlas; Full human Body; MRI
Drug Interaction Study - Assess Pharmacokinetics of Both AZD5672 and Atorvastatin
Condition: Healthy Volunteers; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the pharmacokinetics of both AZD5672 (steady-state) and
      atorvastatin (single dose) when co administered in healthy volunteers
    


Intervention name(s): AZD5672; atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg once daily, 10 days; one single dose of 40 mg on day 10
Other intervention name(s): Lipitor®
Intervention MeSH terms: N-(1-(3-(3,5-difluorophenyl)-3-(4-methanesulfonylphenyl)propyl)piperidin-4-yl)-N-ethyl-2-(4-methanesulfonylphenyl)acetamide; Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: atorvastatin; AZD5672
Effect of Interval and Resistance Exercise on Physiological and Psychological Parameters.
Condition: Body Composition
Study type: Interventional

Summary: 
      The purpose of this study is to examine the physiological and psychological effects of a
      sprint interval and resistance training intervention on females.
    

Detailed description: 
      Females aged 20-65 will attend 10 weeks of exercise training consisting of sprint interval
      training and resistance training for 30 sessions. We will examine changes in body
      composition, blood panel (fasting glucose, cholesterol, triglycerides), strength (bench press
      and back squat), aerobic capacity and psychological parameters (hardiness, affect, enjoyment,
      perception and self-regulation). The effects will be measured acutely after the program and
      6-months after the cessation of the program.
    

Intervention name(s): SIT and resistance training
Intervention type(s): Behavioral
Intervention description(s): Participants complete 30 sessions of sprints and resistance training. Outcomes are assessed acutely and at 6 months.
Intervention model: Single Group Assignment
Intervention model description: All subjects will participate in an exercise intervention consisting of sprint interval training and resistance training.
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Direct Current Stimulation (tDCS) As A Treatment For Cigarette Craving and Cognitive Deficits in Schizophrenic
Condition: Schizophrenia; Cognition; Cigarette Smoking
MeSH terms: Schizophrenia; Cognition Disorders; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This is a study of the effects of tDCS on smoking, craving for cigarettes, cognition, and
      psychiatric symptoms in schizophrenic patients who are current smokers or have a history of
      regular cigarette smoking. It assesses smoking with CO monitoring, nicotine and nicotine
      levels, and craving with QSU scale and response to craving slides. Cognition is measured by
      MCCB, symptoms are measured by PANSS and hallucination scale.

      This is a double-blind sham-controlled study with active tDCS 2ma or 20 minutes over 5 days,
      and sham tDCS for 40 seconds on each sham occasion.
    


Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): Transcranial Direct Current Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Cigarette smoking; Cognition; Craving; MATRICS
Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled APN01 Developed as Treatment for COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      APN01 is a soluble recombinant form of the human angiotensin-converting enzyme 2 (rhACE2)
      that is currently under development as a therapy for corona-virus-disease 2019 (COVID-19). By
      effectively mimicking ACE2 within the body, APN01 is designed to block the SARS-CoV-2 from
      binding to the ACE2 receptor and infecting cells while at the same time downregulating the
      renin-aldosterone-angiotensin system (RAAS) to help prevent inflammation and organ injury -
      critical components involved in the cytokine storm response. ACE2 is the key entry receptor
      for the SARS-CoV-2. Competitive binding by exogenous angiotensin-converting enzyme 2 (ACE2)
      may block viral entry, thereby decreasing viral replication in ACE2 expressing organs and
      protecting the lungs and distal organs from injury induced by SARS-CoV-2.

      APN01 has been developed as an IV agent to treat acute lung injury and pulmonary arterial
      hypertension, and moderate to severe COVID-19 infection. Encouraged by the favorable safety
      profile of IV APN01, we have developed the nebulized APN01 formulation to deliver the drug
      directly to the respiratory tract, where the virus is mainly found, decreasing systemic
      exposure and increasing local pulmonary concentration. APN01 intravenously and as inhalation
      in preclinical studies has been well tolerated with no overall difference in clinical studies
      from placebo in human trials to date.

      This study will investigate nebulized APN01 safety, tolerability, pharmacokinetics,
      pharmacodynamics, and immunogenicity before stepping forward in proof-of-concept studies in
      patients with COVID-19.
    


Intervention name(s): Angiotensin Converting Enzyme 2; Sodium chloride
Intervention type(s): Drug; Drug
Intervention description(s): SAD: single dose; MAD: dosage 2x daily for 7 days; SAD: single dose; MAD: dosage 2x daily for 7 days
Other intervention name(s): Inhalation solution; Inhalation solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Safety and Tolerability of E2730 After Multiple Dose and the Food Effect After Single Dose in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the safety, tolerability, and
      pharmacokinetics (PK) of E2730 of multiple ascending oral doses in healthy adult participants
      and to assess the differences in PK, safety, and tolerability of E2730 between healthy
      Japanese and non-Japanese participants following multiple doses. This study will also
      determine the effect of food on PK of E2730.
    


Intervention name(s): E2730; E2730-matched placebo
Intervention type(s): Drug; Drug
Intervention description(s): E2730 capsules.; E2730-matched placebo capsules.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: E2730; Healthy participants; Pharmacokinetics
SpyGlass Versus ESWL for Large Common Bile Duct Stones
Condition: Choledocholithiasis; Common Bile Duct Calculi
MeSH terms: Choledocholithiasis; Gallstones; Calculi
Study type: Interventional

Summary: 
      Overall stone clearance with endoscopic retrograde cholangiopancreatography (ERCP) for
      choledocholithiasis is a big problem, especially for stones with a diameter greater than 3cm.
      After ERCP failure, surgery was the option but patients not suitable for surgery were treated
      through stenting but had to undergo multiple ERCPs and show a success rate of only 44-96%.
      Recently, choledochoscopic laser, electrohydraulic lithotripsy, SpyGlass, or extracorporeal
      shock wave lithotripsy (ESWL) have been applied for the treatment of huge bile duct stones.
      The present study aims to compare the efficacy and safety outcomes of SpyGlass direct vision
      lithotripsy and ESWL procedures for the removal of large bile duct stones.
    

Detailed description: 
      ESWL was first used for the removal of renal calculi and ureteral calculi however, now a day
      is being used for biliary calculi. It has the advantages of simple operation, low cost, and
      higher safety. Recent studies show that the procedure time for ESWL is also shorter and the
      utilization rate of mechanical lithotripsy was effectively reduced with fewer complications.
      But It is difficult for ESWL to break the stones larger than 3cm into small pieces. So
      SpyGlass-guided laser lithotripsy is used. Spyglass has been used in clinics for more than
      ten years. Recently, a study reported difficult bile duct stones that were treated with
      SpyGlass-guided laser lithotripsy that shows promising results. Compared with laser
      lithotripsy under X-ray monitoring, there is no significant difference in stone removal rate
      and complication rate between the two methods. However, the effect of lithotripsy under
      Spyglass direct vision is better, which can break large stones into smaller pieces, thus
      making it easier to take stones. The investigators conducted the current study to compare the
      therapeutic outcome and complications between SpyGlass direct vision lithotripsy and ESWL
      procedures for the removal of large bile duct stones
    

Intervention name(s): ERCP+ SpyGlass; ESWL+ ERCP
Intervention type(s): Procedure; Procedure
Intervention description(s): SpyGlass direct Vision guided laser lithotripsy; ESWL + Stone removal through ERCP
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Choledocholithiasis; SpyGlass; ESWL;ERCP
SaRS-Cov-2 Antibodies Following Exposure to Coronavirus Disease 2019 (COVID-19) and/or Vaccination in Nursing Homes
Condition: COVID-19 Infection
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Presence of SaRS-Cov-2 antibodies following exposure to Coronavirus Disease 2019 (COVID-19)
      and/or vaccination is a major indicator of immunization. Few data exit about serology
      response in nursing homes (NHs), i.e. in the most vulnerable population for developing severe
      forms of the disease.

      Residents and health professionals in 9 nursing homes (NHs) with SaRS-Cov-2 antibodies
      detection after exposure (either COVID-19 or vaccine) All biological tests were performed in
      the frame of the standard care of residents and health professionals and all participants did
      not express opposition for using anonymously their data for the purpose of this academic
      analysis. In addition all Directors and Physicians of these NHs accepted to participate in
      this study
    


Intervention name(s): SARS-CoV-2 antibodies
Intervention type(s): Diagnostic Test
Intervention description(s): Analysis of the results of the serological response to COVID-19 and/or Vaccine
Intervention MeSH terms: Antibodies
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Residents of the 9 Nursing Homes that participate in this study Health professionals
        working these Nursing Homes
      
Keywords: SARS-CoV-2; Antibodies; Vaccination; Nursing Homes
Comparison of Active Release Technique and Bent Leg Raise In Osteoarthritis.
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The objective of the study was to compare the effects of active release technique and bent
      leg raise on hamstring flexibility, functional outcomes, and pain in patients with knee
      osteoarthritis.
    

Detailed description: 
      Knee Osteoarthritis is a common progressive degenerative joint disease. Muscular weakness and
      other structural abnormalities can cause low back pain. Hamstring muscle being a postural
      muscle has an increased tendency to become tight. In this study, participants with knee
      osteoarthritis having hamstring tightness were included. Active Release Technique and Bent
      Leg Raise technique have been used to increase flexibility in hamstrings in these patients
      with knee osteoarthritis.
    

Intervention name(s): Active Release Technique; Bent leg raise
Intervention type(s): Other; Other
Intervention description(s): Moist Hot pack 10 mins/1 set/ (6 days/ week), TENS 20 mins/1 set/ (6 days/ week), Quadriceps Isometric Strengthening 5 sec hold, 10 reps/ 1 set/(6 days/ week), Active release Technique 5 reps/ 1 set/ (6 days/ week)
A total of 2 weeks (12 sessions, 6 sessions/ week) were given each consisting of 40 mins.; Moist Hot pack 10 mins/1 set/ (6 days/ week), TENS 20 mins/1 set/ (6 days/ week), Quadriceps Isometric Strengthening 5 sec hold, 10 reps/ 1 set/(6 days/ week), Bent leg raise 5 sec hold/ 5 sec stretch/ 3 reps/ 1 min rest interval/ 1 set/ (6 days/ week).
A total of 2 weeks (12 sessions, 6 sessions/ week) were given each consisting of 40 mins.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Active Release Technique; Bent leg raise; Hamstring flexibility
Trauma and Truth Interventions (NET) Versus Conflict Resolution and Social Skills Trainings for Vulnerable Youths in Northern Uganda
Condition: PTSD; Depression; Aggression
MeSH terms: Aggression
Study type: Interventional

Summary: 
      More than 300,000 children are fighting in armed conflicts all over the world. In Uganda an
      estimated number of 25,000 children have been abducted and forced to fight or work as porters
      and sex slaves on the side of the rebels during the conflict between the Lord's Resistance
      Army (LRA) and the Ugandan government. Each year, thousands of former child soldiers have
      returned to their communities after they had fled or were freed from the rebels. It is well
      known that a high percentage of these youths are suffering from mental health problems. This
      could be one of the possible reasons why they are facing difficulties to reintegrate into
      their communities.

      The main aim of the proposed project is two-fold. On the one hand, the investigators want to
      systematically explore the relationship between mental health and important variables for
      reintegration into the communities like aggression, hostility, feelings of revenge,
      compromises and conflict behaviour and readiness for reconciliation in formerly abducted and
      other vulnerable youth (orphans, child mothers and handicapped youths) in Northern Uganda. On
      the other hand, the investigators want to probe the efficacy of existing and newly developed
      interventions for formerly abducted and other vulnerable youths that are supposed to foster
      their mental well-being as well as their reintegration into the society and therewith are
      part of the long-term prevention of new conflicts in Northern Uganda.
    


Intervention name(s): NET Truth Education; Conflict Resolution and Social Competence Skills; Traditional Ways of Coping
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Individual Narrative Exposure and Truth Education in Groups; Conflict Resolution and Social Competence Skills in Groups; Methods Collected by Local Teachers to Help Vulnerable Children and Youths in Northern Uganda
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vulnerable Youths in Northern Uganda; Formerly Abducted Children; Reintegration and Reconciliation; Trauma Treatment; Narrative Exposure Therapy; Reconciliation; Revenge Feelings
Detection of Ischemia in Asymptomatic Diabetics
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Ischemia
Study type: Observational

Summary: 
      Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with
      Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5
      years for the occurrence of cardiac death or non-fatal myocardial infarction.

      The aims are:

        1. To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic
           subjects with Type 2 Diabetes Mellitus.

        2. To identify on the basis of clinical and/or biochemical variables in a high-risk cohort
           in which screening for coronary artery disease is appropriate.

        3. To assess progression of (silent) myocardial ischemia after 3 years.

        4. To assess the occurence of cardiac death or nonfatal myocardial infarction during 5
           years follow-up in screened and not screened subjects.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Asymptomatic patients with type 2 diabetes mellitus
      
Biospecimen description: 
      blood
    
Keywords: silent ischemia; type 2 diabetes mellitus; screening; cardiac outcome; Prevalence silent myocardial ischemia; Cardiac outcome in screened and not-screened subjects