bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to
      show the effect of treatment with liraglutide added to existing glimepiride and metformin
      combination therapy and to compare it with the effects of insulin glargine added to
      combination therapy of glimepiride and metformin.
    


Intervention name(s): liraglutide; insulin glargine; metformin; glimepiride
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Metformin; Insulin Glargine; Liraglutide; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Slider Versus Tensioner Neural Mobilization in Diabetic Peripheral Neuropathy
Condition: Diabetic Peripheral Neuropathic Pain
MeSH terms: Neuralgia; Peripheral Nervous System Diseases
Study type: Interventional

Summary: 
      Neurodynamics, i.e., the mobilization of the peripheral nervous system, is a physical
      approach to the treatment of pain; the method relies on influencing pain physiology via
      mechanical treatment of neural tissues and the non-neural structures surrounding the nervous
      system. Neural mobilization (NM) is used to treat various disorders of the nervous system
      concerning the length and mobility of peripheral nerves, as the nerve mobilizing refers to
      techniques that help to reestablish motion between a nerve and its surrounding soft tissues,
      thus to treat the nerves that have become entangled within the soft tissue, as it leads to
      tension release on a nerve by stretching and pulling one end of the nerve during keeping the
      other end in a relaxed state.
    

Detailed description: 
      The neurodynamic technique both sliders and tensioners results in changes of the mechanical
      or physiological function of nerve tissues along with the interface; restoring pressure
      gradients, relieving hypoxia and pain resulting in reducing associated symptoms.

      Through clinical reasoning the nervous system seems to be the logical place for treatment and
      explanations and previous descriptions of this method have clarified the overall impact on
      quality of life in diabetic peripheral neuropathy but it doesn't discuss which technique of
      neural mobilization is more effective and its effects on diabetic peripheral neuropathic
      population. Within this reasoning it is important to determine which neurodynamic technique
      is more effective in improving quality of life and reduce pain in patients with diabetic
      peripheral neuropathy.
    

Intervention name(s): Sliding Neural mobilization; Tensioner Neural mobilization; Stretching exercises; TENS
Intervention type(s): Other; Other; Other; Device
Intervention description(s): Sliding neural mobilization to femoral, sciatic and tibial nerve; Tensioner neural mobilization to femoral, sciatic and tibial nerve; Stretching exercises; TENS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Neuropsychiatric Function in Patients With Interstitial Lung Disease
Condition: Lung Diseases, Interstitial
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Study type: Observational

Summary: 
      Research on the impact of lung diseases on neuropsychological functioning has revealed
      impaired cognitive processing in patients with a variety of pulmonary disorders. While the
      mechanisms responsible for the association of pulmonary diseases and neurocognitive
      functioning remain unclear, some researchers have attributed it to reduced oxygenation of the
      brain. Early detection and accurate management of comorbidity have benefits in reducing ILD
      morbidity and mortality.
    

Detailed description: 
      Research on the impact of lung diseases on neuropsychological functioning has revealed
      impaired cognitive processing in patients with a variety of pulmonary disorders. While the
      mechanisms responsible for the association of pulmonary diseases and neurocognitive
      functioning remain unclear, some researchers have attributed it to reduced oxygenation of the
      brain.

      Interstitial Lung Disease (ILD) is an "umbrella" term as it comprises a variety of pulmonary
      diseases which affect the interstitium (the tissue and space around the air sacs of the
      lungs). It may be caused by a variety of factors (namely, inhaled substances, medications,
      infection, connective tissue disease, malignancy or idiopathic reasons) and has a clear
      negative impact on patients' quality of life, leading to symptoms such as fatigue, dyspnea
      and coughing. Physical sequelae include reduced lung volumes due to tissue thickening,
      sometimes caused by inflammation. A further consequence is reduced breathing efficiency,
      resulting in reduced blood oxygen levels and compromised exercise capacity.

      Additionally, the fibrosis of the parenchyma impedes the level of gas exchange. A number of
      studies have reported mood effects in ILD, suggesting, however, that the diagnosis of
      depression may be obscured, due to the fatigue and apathy that is often a consequence of ILD.

      Early detection and accurate management of Neuropsychiatric comorbidities have benefits in
      reducing ILD morbidity and mortality.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Interstitial lung disease patients diagnosed using high resolution computed tomography to
        confirm the diagnosis either visiting out patient clinic or admitted to ward in assiut
        university hospital.
      
Keywords: Interstitial lung disease; cognitive function; spirometry; anxiety
Effect of Number of Meals on Metabolism After Weight Loss Surgery
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of meal size and texture on the levels
      of incretin hormone, GLP-1, after Gastric Bypass Surgery (GBP). Patterns of food intake
      change after bariatric surgery and patients often eat multiple small low-calorie meals, a
      pattern that may affect blood glucose as well as incretin levels. Whether the release of
      GLP-1 after an oral challenge or a single liquid meal has any physiological relevance in
      'real life' setting of multiple small meals diet is unclear.
    

Detailed description: 
      The main goal is to study the effect of meal size and texture on incretin levels after GBP.
      Patients will be studied before GBP (T0) and 12-15 months after GBP (T1). At T0 and T1,
      patients will come for 2 study days for 8 hours: On one study day, a single meal will be
      served, on the second study day, three small meals, with the order of the conditions randomly
      assigned. The total amount of calories (600 kcal) and the over all nutrient composition (55%
      CHO, 15 % protein, 30% fat) will be equivalent between conditions. The meals will be either
      all solid or all liquid. Patients enrolled in the study will be randomly assigned to solid or
      liquid test meals.

      Recruitment and data gathering for this study were performed at St. Luke's Hospital in New
      York, NY. Data Analysis was performed at Columbia University Medical Center in New York, NY.
    

Intervention name(s): Solid Meal; Liquid Meal; Acetaminophen; Single, 600 kcal meal; Multiple, 200 kcal meals
Intervention type(s): Other; Other; Drug; Other; Other
Intervention description(s): Subjects will receive solid meals during meal study; Subjects will receive liquid meals, during meal study; All subjects given acetaminophen to measure gastric emptying; Subjects will receive a single, 600 kcal meal during meal study; Subjects will receive three, 200 kcal meals, during meal study
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gastric Bypass; Meal Texture; Meal Number; GLP-1; Glucose
ARROW:identificAtion of postpRandial biomaRkers tOWards Cardiovascular Prevention
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      The purpose of this study is to better understand the association between the postprandial
      biomarker responses after a food challenge with the development of cardiovascular diseases in
      healthy subjects
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        This study will be performed in 100 Chinese subjects at low risk of developing
        cardiovascular diseases, as defined by the Framingham Heart Study Coronary Heart Disease
        10-year risk score with or without subclinical atherosclerosis.
      
Biospecimen description: 
      Blood and plasma
Long-term Efficacy and Safety of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy and safety of ASP8825 (gabapentin
      enacarbil) for long-term treatment of restless legs syndrome patients.
    


Intervention name(s): ASP8825
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): gabapentin enacarbil
Intervention MeSH terms: Gabapentin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Restless legs syndrome patients; ASP8825; XP13512
HBV-specific T-cell Immunity in Individuals With HIV/HBV Co-infection
Condition: HIV; Hepatitis-B
MeSH terms: Infections; Hepatitis B; Coinfection; Hepatitis
Study type: Observational

Summary: 
      The trial will randomise HIV/HBV co-infected individuals to different HBV-active
      antiretroviral therapy treatment regimens.
    

Detailed description: 
      Longitudinal study of circulating and intra-hepatic HBV-specific T-cell immunity in the
      setting of a randomised, controlled, international, multi-centre outpatient trial. The trial
      will randomise HIV/HBV co-infected individuals to different HBV-active antiretroviral therapy
      treatment regimens.

      Study population: Patients with HIV/HBV co-infection who are naive to HIV/HBV therapy, have
      detectable HBV viremia and are willing to start antiretroviral therapy.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV/Hepatitis B coinfected patients using at least one hepatitis active medications in
        HAART regimen
      
Biospecimen description: 
      PBMC
    
Keywords: HIV infection; Hepatitis coinfection
Biomarker Discovery in Two Daily Disposable Contact Lenses
Condition: Visual Acuity
Study type: Observational

Summary: 
      This is a non-masked, non-randomized, stratified, 4-arm parallel group, non-interventional
      study where subjects will be enrolled into one of four arms based on their habitual contact
      lenses. Subjects will be wearing their habitual contact lenses throughout the study and will
      be scheduled for morning and afternoon visits totaling 10 visits with a ~4-week washout
      period between visits 6 and 7.
    


Intervention name(s): JJVC Contact Lens; Marketed Contact Lens
Intervention type(s): Device; Device
Intervention description(s): etafilcon A with PVP DD; nelfilcon A DD
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study subjects will be recruited from the Institution/clinical site's subject database
        and/or utilizing Independent Ethics Committee (IEC) or Institutional Review Board (IRB)
        approved materials.
Lenvatinib Combined With Gefitinib in the Treatment of Lenvatinib-resistant Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma; Molecular Targeted Therapy
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      This is a prospective clinical study aiming to tests the safety and efficacy of lenvatinib in
      combination with gefitinib in people with lenvatinib resistant hepatocellular carcinoma. This
      study will help find out if lenvatinib and gefitinib is a safe and useful combination for
      treating patients with lenvatinib resistant hepatocellular carcinoma.
    


Intervention name(s): Lenvatinib and Gefitinib
Intervention type(s): Drug
Intervention description(s): First week: Gefitinib: 125mg/day, oral; Lenvatinib: 8mg/day (weight ≤ 60Kg) or 12mg/day (weight > 60Kg), oral.
One week later: Gefitinib: 250mg/day, oral; Lenvatinib: 8mg/day (weight ≤ 60Kg) or 12mg/day (weight > 60Kg), oral.
Intervention MeSH terms: Lenvatinib; Gefitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hepatocellular carcinoma; lenvatinib; gefitinib
A Study of JNJ-70033093 (BMS-986177) in Healthy Chinese Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to characterize the pharmacokinetics of single and multiple doses
      of JNJ-70033093 (BMS-986177) in healthy Chinese participants.
    


Intervention name(s): JNJ-70033093
Intervention type(s): Drug
Intervention description(s): JNJ-70033093 capsule will be administered orally as per assigned treatment regimen.
Other intervention name(s): BMS-986177
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of Low Bone Mass in Premenopausal or Perimenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      OBJECTIVES:

      I. Determine the possible causes of bone loss in premenopausal or perimenopausal women.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients undergo physical examination and complete history with emphasis on
      risk factors for osteoporosis and screening for occult secondary causes of osteoporosis
      through blood serum and 24 hour urine collection.

      Patients with more than 6 months since prior bone mineral density measurements or who did not
      receive measurements at participating center, undergo dual energy x-ray absorptiometry over
      30 minutes for bone mineral density measurements.
    

Keywords: disease-related problem/condition; osteoporosis; rare disease
Benefits of Digital Dance Game by Older Adults
Condition: Aged
Study type: Interventional

Summary: 
      This study aims to examine the clinical efficacy of dancing somatosensory videogames in
      improving physical health, cognitive performance, happiness, laboratory biomarkers, and
      structural brain imaging (magnetic resonance imaging, MRI) by a randomized controlled trial
      design, and hopefully to expand the scope of healthy aging intervention activities with
      strong scientific evidence.
    

Detailed description: 
      This randomized controlled trial followed the CONSORT guidelines to compare the clinical
      efficacy of the intervention group with the control group. The intervention group and control
      group were randomly allocated (1:1) with no stratification. The intervention group received
      the dance somatosensory videogame (DSG) training program at the community health center,
      which consisted of two 30-minute sessions per week for 6 months. The control group were
      provided with health education for healthy aging and were followed by telephone survey for
      their daily activities every month during the study period.

      The primary outcome of the trial was changes of gray matter volume of the brain done by 3T
      brain magnetic resonance imaging during the study period. The secondary outcomes included
      cognitive performance, quality of life, physical activities, resilience, and demoralization.
      For all outcome variables, the measurements at the baseline and 6-month follow-up were
      examined by a random intercept and a fixed slope, and the effect of the intervention was
      estimated by using the Generalized Estimating Equation.
    

Intervention name(s): Dance somatosensory game
Intervention type(s): Device
Intervention description(s): dance somatosensory game (DSG), DANZ BASE developed by International Games System Company
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The intervention group and control group were randomly allocated (1:1) with no stratification. The intervention group received the dance somatosensory videogame (DSG) training program at the community health center, which consisted of two 30-minute sessions per week for 6 months. The control group were provided with health education for healthy aging and were followed by telephone survey for their daily activities every month during the study period.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Digital dance game; older adults; Brain gray matter volume; cognitive performance
Moderate Alcohol Consumption, Fat and Carbohydrate Metabolism and Insulin Sensitivity
Condition: Diabetes Mellitus, Type 2; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Alcohol Drinking
Study type: Interventional

Summary: 
      Moderate alcohol consumption is associated with a decreased risk of diabetes type 2. This
      association could be mediated by an improvement of insulin sensitivity with moderate alcohol
      consumption. Patients with diabetes type 2 or impaired glucose tolerance often may have
      decreased fat oxidative capacity or oxidative phosphorylation in tissue such as muscle. This
      could lead to accumulation triglyceride storage in muscle, which could interfere with insulin
      signaling. Whether such mechanism can also play a role with moderate alcohol consumption is
      unknown and will be investigated in this study.

      In addition, moderate alcohol consumption with a meal can lead to delayed hypoglycemia in
      type 1 diabetes patients. How moderate alcohol consumption affects postprandial glycemic
      response in healthy subjects is unknown. This is a secondary objective of this trial.
    

Detailed description: 
      To investigate the effect of moderate alcohol consumption on

        -  enzymes involved in fatty acid oxidation, oxidative phosphorylation and glycolysis in
           skeletal muscle

        -  transporters of fatty acids and glucose in fat tissue

        -  post-prandial glycemic response in healthy, lean or overweight, young men

      Design : Open, randomized, partially diet-controlled, placebo controlled cross-over design

      Participants

        -  Description : Healthy, lean and overweight young (18-40 years) men

        -  Number : 20

      Study substances

        -  Test substance : 100 ml whiskey (Famous Grouse, 40% v/v alcohol: ≈ 32 g alcohol)

        -  Reference substance : 100 ml mineral water (Spa blauw)

      Duration: 2 treatment periods of 4 weeks (28 days)

      Test parameters:

        -  Muscle biopsy for activity of 3-hydroxy fatty-acyl CoA dehydrogenase, citrate synthase,
           cytochrome c oxidase

        -  Postprandial glycemic response (glucose, insulin, GLP-1, GLP-2, GIP, glucagon, FFA etc.)

        -  Insulin sensitivity and related factors (oral glucose tolerance test, adiponectin,
           HbA1c)

        -  Liver enzymes (safety)

        -  Body weight

        -  Urinary ethyl glucuronide (compliance)
    

Intervention name(s): A; B
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Alcohol consumption (32 g/day) for 4 weeks; Water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Moderate alcohol consumption; Fat and carbohydrate oxidative capacity; Postprandial glycemic response
Hypocaloric Enteral Nutrition in the Critically Ill Patient
Condition: Critically Ill
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare two nutritional regimes in critically ill patients.
      Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15
      kcal per kg). Both regimes will recive 1,7 g/Kg/dia The main outcome will be the SOFA
      (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic
      diet decreases the incidence of organic failure in these patients.
    

Detailed description: 
      The research site will be the intensive care unit (ICU) of Hospital Universitario San
      Ignacio; eligible patients will >18 years of age with a presumed fasting period of at least
      96 hours, with no contraindications for enteral nutrition. Patients with parenteral
      nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or
      admitted from another hospital will be excluded. In all patients, the following information
      will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in
      IU), presence of hyper or hypoglicemia, presence of infections, among others.

      The SOFA score will be assessed every two days until discharge from ICU.
    

Intervention name(s): Hipocaloric enteral nutrition; Normocaloric enteral nutrition
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 15 kcal/Kg of body weight; 25 kcal/kg of body weight
Other intervention name(s): low caloric delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Critically ill; Enteral nutrition
Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial will determine the Pharmacokinetics, safety and tolerability of single-dose
      Aripiprazole administered intramuscularly in adults with schizophrenia
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Injection
Other intervention name(s): Abilify Maintena
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care