bioihbjkbjnl/mcl2 huggingface dataset:
CALERIE (PBRC, Baton Rouge) - Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy
Condition: Aging; Cardiovascular Disease; Diabetes Mellitus
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study is one of three CALERIE trials that test the hypothesis that a reduced calorie,
      nutritionally sound diet improves biomarkers of aging and prevents some age-related chronic
      diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are
      participating in the CALERIE trial represent a diversity of subject populations and
      interventional strategies.
    

Detailed description: 
      This study tests whether chronic caloric restriction improves risk factors of longevity in
      humans as it is known to do in animals, by measuring a variety of factors dealing with
      metabolism and oxidative stress, through physical evaluations and laboratory tests.

      Participants will receive dietary counseling and free medical evaluations. In addition, each
      volunteer will be asked to do one of the following:

        1. Follow a reduced calorie diet

        2. Follow a reduced calorie diet using a liquid diet

        3. Increase physical activity while on a reduced calorie diet

        4. Follow a standard diet.

      Three separate five-day inpatient stays are required.
    

Intervention name(s): Caloric Restriction (CR); Exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Longevity; Dietary restriction; Physical activity; Weight Loss; Diabetes
Efficacy of Racecadotril in Acute Watery Diarrhea in Children
Condition: Acute Diarrhea; Acute Gastroenteritis
MeSH terms: Gastroenteritis; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of racecadotril in acute watery diarrhea
      in children. The investigators will evaluate the effect of product versus placebo.
    

Detailed description: 
      Background: Treatment of acute diarrhea is based on the following various oral rehydration
      management guidelines. Lately other drugs currently under investigation as antisecretory
      drugs to shorten the diarrheal episode and can be used safely in children.

      Objectives: To evaluate the effect of racecadotril in the treatment of children under 5 years
      of age with acute diarrhea.

      Methods: A randomized clinical trial, controlled, double-blind. The investigators will have
      two groups of patients: One group will receive racecadotril plus oral rehydration and the
      other one will receive placebo plus oral rehydration; the parameters of evaluation are going
      to be the duration of diarrheal episode, number of stools by day, weight of stool,
      nutritional state.
    

Intervention name(s): Racecadotril; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day; cornstarch powder diluted in distilled water, dosage 2.5 ml per dose
Other intervention name(s): Hidrasec
Intervention MeSH terms: Racecadotril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: acute diarrhea; Racecadotril; children
Memory and Mental Health in Aging
Condition: Memory Disorders
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of donepezil (Aricept®) and cognitive training in
      improving memory performance in elderly adults.
    

Detailed description: 
      The drug donepezil plus cognitive training may work better than cognitive training alone to
      improve the memory of nondemented older adults. In this study, participants are assigned
      randomly to receive either donepezil plus cognitive training or placebo plus cognitive
      training. Memory and quality of life tests are used to evaluate the effects of the study
      treatments.
    

Intervention name(s): donepezil; Memory-training class
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Memory
Comparison of Occlusive and Classical Hypertrophy Training in Terms of Thickness and Stiffness of The Muscle
Condition: Muscle Tightness; Hypertrophy; Occlusion Vein
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      Occlusive or ischemic training is a type of strength training which is becoming more and more
      popular every day. The safety, efficacy and detailed description about the use of occlusive
      training is well documented in the literature. However, the effects on hypertrophy and the
      stiffness of the muscle tissue are not studied. We aimed to measure these changes by
      ultrasound technology in a randomized controlled design.
    

Detailed description: 
      Patients were randomized into classical hypertrophy and occlusive hypertrophy groups. The
      participants are free from any systemic disease, infection or recent injury. Both groups
      perform hypertrophy training with different intensities. The outcome measures are; thickness
      determined by B-mode ultrasound and stiffness by shear-wave elastography. Comparison of both
      groups will be made.
    

Intervention name(s): Heavy hypertrophy training; Light hypertrophy training
Intervention type(s): Other; Other
Intervention description(s): Training with 75-80 % of 1-RM; Training with 35-50 % of 1-RM
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Biomechanics; Strength training; Elastography; Ultrasound
The Efficacy and Safety of Liraglutide on Body Weight Loss in Obese and Overweight Patients
Condition: Obese; Overweight
MeSH terms: Overweight; Weight Loss; Body Weight
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the
      effect and safety of Liraglutide Injection on body weight loss compared with placebo in obese
      or overweight adult patients with comorbidity of metabolic disorders.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial.
      The total study duration is 34~36 weeks, including 2-week screening period, 6~8-week dosage
      titration, 24-week stable treatment and 2-week safety follow-up period. Subjects with obesity
      or overweight with comorbidity of metabolic disorders receive subcutaneous injection of 3.0
      mg Liraglutide or placebo every day. The primary endpoint is the change of body weight or the
      percentage of body weight loss greater than 5%. The changes of body weight between
      Liraglutide Injection group and placebo group will be compared. In the course of the trial,
      the subjects are weighted on fasting state. Blood samples are collected according to the
      protocol. All subjects receive lifestyle intervention, including a reductiong of calorie
      intake by 500 kcal a day and physical exercise.
    

Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Liraglutide Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Liraglutide Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.; Placebo Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Placebo Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The total study duration is 34~36 weeks, including 2-week screening, 6~8-week dosage titration, 24-week stable treatment and 2-week safety follow-up.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: weight loss; obeses; overwweight; Liraglutide
Comparison of Two Dose Strengths of Selexipag in Healthy Adults
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the
      tablet developed for children.
    

Detailed description: 
      Healthy male adults receive a single dose of selexipag (200 µg) but using a different tablet
      strength (4 film-coated pediatric tablets of 50 µg versus one film-coated tablet of 200 µg
      selexipag) during each of the two study periods. There is a washout of 7-9 days between the
      two study treatment administrations.
    

Intervention name(s): Selexipag (adult formulation); Selexipag (pediatric formulation)
Intervention type(s): Drug; Drug
Intervention description(s): One selexipag film-coated tablet of 200 µg; Four selexipag film-coated tablets of 50 µg
Other intervention name(s): ACT-293987; ACT-293987
Intervention MeSH terms: Selexipag
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: selexipag; pharmacokinetics
Dexmedetomidine Facilitate Analgesia
Condition: Lower Limb Fracture; Nerve Block
Study type: Interventional
Phase: Phase 4

Summary: 
      Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of
      spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive
      substances and further interrupting the spinal neuron-glia cross talk and regulating the
      nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy
      of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this
      study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy
      of Dexmedetomidine compared with Midazolam.
    

Detailed description: 
      Pre-clinic evidences showed that DEX produces antinociception by inhibiting the activation of
      spinal microglia and astrocyte decreasing noxious stimuli evoked release of nociceptive
      substances and further interrupting the spinal neuron-glia cross talk and regulating the
      nociceptive transmission under chronic pain condition. in this study, the analgesic efficacy
      of Dexmedetomidine was evaluated by a new non-invasive nociceptive index (qNOX). In this
      study, Anagel6000 analgesia monitor was used to quantitatively compare the analgesic efficacy
      of Dexmedetomidine compared with Midazolam.
    

Intervention name(s): Dexmedetomidine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine group (Group D) was given 1.5ug/kg/h Dexmedetomidine continuous infusion; Midazolam group (Group M) was continuously pumped with 0.05mg/kg/h midazolam
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Dexmedetomidine; nociceptive index
Trigger Point Massage in Chronic Tension Headache
Condition: Tension-Type Headache
MeSH terms: Tension-Type Headache; Headache
Study type: Interventional

Summary: 
      Patients with IHS criteria of chronic tension headache , considering inclusion and exclusion
      criteria, enrolled to this study. They will be randomized to intervention or control group by
      block randomization method, then treat by standard drug( nortriptyline 10 mg daily) or
      trigger point massage.

      They report severity, frequency, duration of headaches and number of analgesic drugs in diary
      during week 1 and week 4. Then data based on dairy will be analysis.
    


Intervention name(s): Massage
Intervention type(s): Other
Intervention description(s): Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Case and control group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Massage; Trigger point
The Improvements of Dietary Supplement of Black Rice on Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to thoroughly investigate how the interaction between black rice
      and human gut microbiota affects metabolic diseases, this study will recruit patients with
      Metabolic Syndrome (MS) and provide them with dietary supplementation of black rice (50
      g/day) for 3 months to observe its effect on the development of MS. The focuses of this
      project are to elucidate how black rice consumption affects the composition and metabolism of
      intestinal bacteria as well as the development of MS, and to further analyze whether the
      changes in intestinal bacteria are associated with the changes in MS improvements.
    


Intervention name(s): Black rice; follow-up
Intervention type(s): Dietary Supplement; Other
Intervention description(s): They asked to keep their normal life style during intervention; They asked not to consume any black rice or excess amount of food rich in anthocyanin compared to their normal life style, such as grapes, blueberry, red wine, black bean during intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metabolic Syndrome; black rice
A 12-Week Study in Participants With Refractory Chronic Cough (MK-7264-012)
Condition: Refractory Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the efficacy of three dose regimens of gefapixant
      ([MK-7264] 7.5 mg, 20 mg, and 50 mg) relative to placebo in reducing awake objective cough
      frequency. The primary hypothesis for this trial is that at least one dose regimen of
      gefapixant is superior to placebo with respect to the mean change from baseline in awake
      cough frequency (on the log scale).
    


Intervention name(s): Gefapixant; Placebo (for gefapixant)
Intervention type(s): Drug; Drug
Intervention description(s): Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.
Other intervention name(s): AF-219; MK-7264; Dose-matched placebo tablet to gefapixant administered twice daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Donor Simvastatin Treatment in Organ Transplantation
Condition: Heart Failure; Respiratory Failure; Liver Failure; Kidney Failure; Transplantation
MeSH terms: Liver Failure; Respiratory Insufficiency; Renal Insufficiency
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the study is to investigate the effects of donor simvastatin treatment on
      ischemia-reperfusion injury after heart transplantation.
    

Detailed description: 
      The study hypothesis of the single center randomized double-blinded clinical trial is that
      donor simvastatin treatment reduces ischemia-reperfusion injury after heart transplantation.
      Also, it potentially decreases natural immune activity, rejection activation and thus
      improves long-term prognosis.

      Simvastatin is administered to heart and/or lung donors through the nasogastric tube 4-6
      hours prior to organ harvesting. Control organ donors do not receive simvastatin. The
      randomization and donor hospital instruction of the donor simvastatin treatment is performed
      by the transplant coordinator. All other caregivers and the transplant recipient are blinded
      to the treatment group allocation.

      The impact of donor simvastatin treatment is investigated and analyzed by several specific
      blood samples and biopsies that are taken from the recipient at the various time-points
      during the perioperative and postoperative phase.

      In heart transplant recipients (n=42 in the donor simvastatin treatment group and n=42 in the
      control group), the primary end-point is postoperative cardiac enzyme serum levels (TnT, TnI,
      and CK-MB 1 hour, 6 hours, 12 hours and 24 hours after transplantation) and primary graft
      failure. Secondary end-points include peri- and postoperative parameters hemodynamics, short-
      and long term survival, biopsy-proven rejections, rejection treatments, and chronic rejection
      at 1, 5, 10, and 20 years after transplantation.

      Lung, kidney and liver transplant recipients that have received organs from donors randomized
      to the control group or donor simvastatin group will also be followed for
      ischemia-reperfusion injury, perioperative organ function, innate and adaptive immunity and
      patient survival.
    

Intervention name(s): Simvastatin 80mg; Control Rx
Intervention type(s): Drug; Drug
Intervention description(s): The transplant recipients who have received an organ from donors treated with simvastatin 80 mg.; The transplant recipients who have received an organ from non-treated donors.
Other intervention name(s): simvastatin
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transplantation; Simvastatin treatment; Ischemia-reperfusion injury; Rejection
A Study of LY3375880 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in
      healthy participants and what side effects may occur. The study drug will be administered
      either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm.

      This is a two-part study. Participants will enroll in only one part. Part one will last about
      16 weeks including screening and follow-up. This part will include 2 nights at the study
      site. Part two will last about 20 weeks including screening and follow-up. This part will
      include 2 nights at the study site for each dose.
    


Intervention name(s): LY3375880 IV; LY3375880 SC; Placebo IV; Placebo SC
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): administered IV; administered SC; administered IV; administered SC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Early Mobilization After Arthroplasty
Condition: Mobility
Study type: Observational [Patient Registry]

Summary: 
      Aims and Objectives: This study was conducted in order to determine the factors that affected
      the early mobilization after surgery of patients who had undergone knee and hip arthroplasty.

      Background: Early mobilization in knee and hip arthroplasty is still not at the desired
      level, and it is among the most frequently overlooked nursing practices.

      Desing: This study is descriptive and cross-sectional. STROBE checlist was used to compile
      the study's report.

      Methods: The universe of the study consisted of a total of 80 patients who were hospitalized
      between 07 November 2017 and 21 September 2018 in the Orthopedics and Traumatology Clinic of
      a State Hospital to undergo knee or hip arthroplasty, and who met the inclusion criteria. The
      sample of the study consisted of 60 patients who were in the universe of the study, who met
      the inclusion criteria and who voluntarily agreed to participate in the study.
    


Intervention name(s): early mobilization
Intervention type(s): Other
Intervention description(s): early mobilization was defined, on the basis of the ERAS protocol, as mobilization of a few steps or a few meters from the bed within the first 24 hours after surgery with another person's support/control and/or a walking aid.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The universe of the study consisted of a total of 80 patients who were hospitalized between
        November 2017 and September 2018 in the Orthopedics and Traumatology Clinic of a State
        Hospital to undergo knee or hip arthroplasty, and who met the inclusion criteria. The
        improbable sampling method was used in the study. The sample of the study consisted of 60
        patients who were in the universe of the study, who met the inclusion criteria and who
        voluntarily agreed to participate in the study.
      
Keywords: Early Mobilization; Enhanced Recovery After Surgery (ERAS); Arthroplasty; Nursing