bioihbjkbjnl/mcl2 huggingface dataset:
Duodenal Switch With a Standard Versus Long Alimentary Limb
Condition: Obesity, Morbid; Bariatric Surgery Candidate; Metabolism Disorder
MeSH terms: Metabolic Diseases; Obesity, Morbid
Study type: Interventional

Summary: 
      The aim of this study was to determine if Biliopancreatic Diversion with Duodenal Switch
      (BPD-DS) with a longer strict alimentary limb at the expense of a shorter biliopancreatic
      limb will offer significant weight lost, but with lesser gastrointestinal complaints, protein
      deficiency, vitamin and trace element deficit compared to standard BPD-DS.
    

Detailed description: 
      This two-group, randomized, single-blind pilot study is conducted in a university-affiliated
      tertiary care center. The study protocol was approved by our ethic committee. Enrollment and
      randomization of the patients occurred between May 20163 and June 2015. Patients are
      undergoing follow-up evaluation. Patients were initially referred to our center for a
      bariatric surgery evaluation. Eligible patients were 18 years of age or older and met the
      criteria for a laparoscopic biliopancreatic diversion. Patients were excluded if they had a
      BMI ≥ 50 mg/m², a pacemaker, cirrhosis or if they were planing pregnancy in the next 2 years.
      Each patient was required to provide written informed consent. Patients were randomly
      assigned in a 1:1 ratio to undergo a standard biliopancreatic diversion (control group) or a
      modified biliopancreatic diversion with a longer strict alimentary limb (study group). A
      sealed envelope with the assignation was given to the surgeon in the operation room just
      before the procedure. Patients are followed every 6 months after surgery, up to 24-months for
      clinical evaluation, resolution of comorbidities, evaluation of side-effects, quality of
      life, bioimpedance testing and bloodwork.
    

Intervention name(s): Long alimentary limb BPD-DS
Intervention type(s): Procedure
Intervention description(s): BPD-DS with a long strict alimentary limb and a 100-cm common channel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Oxytocin Effects on Likeability After Being Liked or Disliked
Condition: Social Behavior
Study type: Interventional

Summary: 
      The current study aimed to investigate oxytocin effect on the response after the experience
      of being liked or disliked.
    

Detailed description: 
      In a double-blind, between-subject, placebo controlled design study, the researchers aimed to
      investigate the intranasal OXT (40IU) treatment on rating response after being liked or
      disliked in healthy male subjects. All subjects completed a range of questionnaires measuring
      personality and affective traits and levels of anxiety: Positive and Negative Affect Schedule
      (PANAS) , State-Trait Anxiety Inventory (STAI) , Beck Depression Inventory (BDI), Cheek and
      Buss shyness Scale (CBSS),Autism Spectrum Quotient (ASQ), Empathy Quotient(EQ) before
      self-administration.Study participants were led to believe that other participants had formed
      an opinion on their likability based on their appearance in a photograph and they passively
      viewed the responses (like or dislike) from 'other participants'. After that, they rated
      'other participants' about likeability (how much do you like the person), accuracy (have you
      seen the person), feeling (how good do you feel), and tendency (how much would do like have
      him/her as a friend). Likeability, tendency, feeling and accuracy were included into analysis
      as dependent variables.
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Likeability; Being liked
Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth
Condition: Preterm Birth; Health Care Utilization; Tobacco Use; Contraceptive Usage; Depression; Weight, Birth
MeSH terms: Premature Birth; Birth Weight
Study type: Interventional

Summary: 
      This study continues an adaptation of care coordination to address the needs of women after
      preterm birth. This is a small single arm open trial designed to test intervention
      implementation and refine the intervention before ongoing feasibility testing.
    

Detailed description: 
      Interventionists will be trained in care coordination strategies and Motivational
      Interviewing (MI) techniques. Following training, investigators will enroll eligible women
      from a postpartum unit at a single hospital, or within two weeks of birth. Investigators will
      assess feasibility, adoption, reach, and fidelity of the intervention and of study data
      collections strategies. The intervention protocol will be revised to reflect these
      assessments.
    

Intervention name(s): Care coordination and motivational interviewing
Intervention type(s): Behavioral
Intervention description(s): Interventionist will engage participants in care planning, health education, health care navigation, screening for unmet health needs or social needs, and motivational interviewing. The final intervention is expected to be six months in duration. However during this single-arm open testing phase, some participants may receive only key components of the intervention in order to assess feasibility, reach, adoption, and fidelity of those components.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preconception care; Interconception care; Postpartum care; Preventive health care; Care coordination; Motivational Interviewing
Physiological Effect of Ataulfo Mango (Manguifera Indica) Beverage in Exercise
Condition: Exercise-induced Oxidative Stress
Study type: Interventional

Summary: 
      The aim of this study is to assess the antioxidant capacity of two mango base beverages (AM1,
      AM2), against exercise-induced oxidative stress.
    

Detailed description: 
      Introduction. The post-consumption physiological effect of mango cv. "Ataulfo" pulp (MP) and
      peel (MC) in humans before exercise has been poorly evaluated.

      Objective. To evaluate the physiological response, to consumption of two mango base
      beverages, AM1 (200g MP/ 600mL water) and AM2 (160g MP; 40g MC / 600mL water), before and
      after a submaximal exercise test.

      Methods. The antioxidant profile and physicochemical characteristics of AM1 and AM2 were
      evaluated. Several cardiorespiratory, anthropometric and body composition parameters of 19
      university students, prior to the consumption of AM1, AM2 and water, were evaluated in three
      non-consecutive sessions (self-control cases). The glycemic, lactic and antioxidant (FRAP),
      uric acid (AU), reduced glutathione (GSH) and lipid oxidation (TBARS) and protein carbonyls
      (PC) responses were evaluated in plasma before and after an incremental cycle ergometer
      exercise test.
    

Intervention name(s): Mango pulp beverage; Mango pulp and peel beverage; Control beverage
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The subject consumes mango pulp beverage (200 g mango pulp + 600 mL water). 2 hours later subject performs the exercise test.
Washout: 1 week washout period prior to the administration of this intervention to avoid possible carryover effect.; The subject consumes mango pulp and peel beverage (160 g mango pulp + 40 g mango peel + 600 mL water). 2 hours later subject performs the exercise test.
Washout: 1 week washout period prior to the administration of this intervention to avoid possible carryover effect.; The subject consumes control beverage (600 mL water). 2 hours later subject performs the exercise test.
Washout: 1 week washout period prior to the administration of this intervention to avoid possible carryover effect.
Other intervention name(s): AM1; 200 g mango pulp + 600 mL water; AM2; 160 g mango pulp + 40 g mango peel + 600 mL water; 600 mL water
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The prescription of the treatments (AM1, AM2) and control (water) was randomized. The subject consumed 600mL of AM1, AM2 or water. 2 hours later subject performed the exercise test. Next treatment was evaluated after a week of wash-out.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Exercise; Oxidative stress; Antioxidant
Effectiveness of the Kinesio Taping® in Muscle Activation
Condition: Muscle Atrophy
MeSH terms: Muscular Atrophy
Study type: Interventional

Summary: 
      Forty-eight female patients will be randomized into three groups to receive the Kinesio
      taping, placebo Kinesio taping and control group. The group Kinesio taping receive the
      correct application of the method described. The placebo group will receive a placement
      without tension. The control group did not receive any form of intervention.
    

Detailed description: 
      The group Kinesio taping receive the correct application of the method described with tension
      of 40%. The placebo group will receive a placement without tension.

      The control group did not receive any form of intervention.
    

Intervention name(s): Kinesio Taping
Intervention type(s): Other
Intervention description(s): Kinesiotaping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the quadriceps muscle.
Other intervention name(s): -Bandages; -Tape; -Taping; -Kinesio Tex; -Kinesio Tape; -Kinesiotape
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: kinesio taping; Muscle activation; Muscle inhibition
Spironolactone Against Anthracycline-induced Cardiomyopathy
Condition: Anthracycline Induced Cardiotoxicity
MeSH terms: Cardiomyopathies; Cardiotoxicity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study sought to investigate the whether spironolactone protects the heart against
      anthracycline-induced cardiotoxicity.
    

Detailed description: 
      Anthracyclines are the cornerstone in the treatment of numerous hematological and solid
      cancers. The most common side effect of anthracycline is cardiotoxicity and this may limits
      its use and increases the rate of mortality and morbidity. Cardiotoxicity is cumulative, dose
      dependent, and irreversible. Improvements in protective mechanisms against the cardiotoxicity
      of anthracycline are important to prevent the discontinuance of these chemotherapeutics.

      Spironolactone is an aldosterone antagonist which blocks the last step of the rennin
      angiotensin aldosterone system (RAAS). The RAAS is one of the most effective systems in
      remodeling of the myocardium in post-myocardial damage. According to the RALES study, in
      patients with severe heart failure, 25 mg spironolactone per day in addition to the standard
      therapy has positive effects, particularly on cardiac fibrosis and on remodeling, and
      substantially reduces the risk of both morbidity and death. In the EPHESUS study, it has been
      shown that, after the myocardial damage due to infarction, the administration of aldosterone
      antagonists had positive effects on the remodeling process, left ventricular ejection
      fraction and primer end-points. In the present study, we tested the hypothesis that RAAS
      blockage with spironolactone may reduce the cardiotoxicity of anthracycline group
      chemotherapeutics.
    

Intervention name(s): Spironolactone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Spironolactone; Placebo
Other intervention name(s): 25 mg spironolactone orally
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anthracycline; spironolactone; cardiotoxicity
Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Paclitaxel in Triple Negative Breast Cancer (TNBC)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective, multi-center, open-labeled, randomized phase III clinical trial
      comparing overall response rate (ORR), progression free survival (PFS), overall survival (OS)
      and toxicity obtained with gemcitabine cisplatin combination (GP) versus gemcitabine
      paclitaxel combination (GT).
    

Detailed description: 
      The previous phase II study showed that gemcitabine and cisplatin combination (GP) is an
      effective regimen in triple negative breast cancer (TNBC). The potential therapeutic effects
      of GP in advanced TNBC deserve further evaluation yet. Eligible patients are randomly
      assigned to receive either GP or GT regimen to verify the hypothesis.
    

Intervention name(s): Gemcitabine,cisplatin; Gemcitabine, Paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1; Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Paclitaxel 175 mg/m2, IV, 3h,D1
Other intervention name(s): experimental arm; control arm
Intervention MeSH terms: Paclitaxel; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: triple negative breast cancer; fine line chemotherapy
Nurse Intervention Project
Condition: Breast Cancer Patients
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The use of interventions for cancer-related distress is important to reduce this distress.
      Distress has a negative impact on quality of life, the recovery during and after treatment
      and may even adversely affect survival. There is insufficient attention to the systematic
      approach to psychosocial problems in cancer patients in the Netherlands. A task force
      discussed and studied which instrument measures psychosocial problems best. The distress
      thermometer ("lastmeter") had the best results. A guideline is written to use the distress
      thermometer for patients with cancer and will be used in hospitals in the Netherlands.
      However, it is not clear what the effects are of the use of the distress thermometer on the
      psychosocial wellbeing of the patient. Furthermore, it is also unknown whether the use of the
      distress thermometer leads to cost-effective care. The study focuses on the use of the
      distress thermometer in breast cancer patients. An efficiency study (RCT) will be conducted
      to evaluate the systematic use of the distress thermometer and its discussion by a nurse as
      compared to the usual care provided to outpatients who are treated with curative intent for
      breast cancer by their treating physicians. The clinical and economic impact of the use of
      the Distress thermometer will be assessed in comparison with usual care.The recruitment of
      patients will take place in the out-patient clinic of a university hospital. Patients will be
      followed from diagnose until two years after finishing their treatment.
    


Intervention name(s): distress thermometer
Intervention type(s): Device
Intervention description(s): to apply the distress thermometer as written in the guideline written by 'Vereniging Integrale Kankercentra' title: 'Detecteren behoefte psychosociale zorg. The distress thermometer is collected from the experimental group and then discussed by a trained nurse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Video Balance-based Exercise in Persons With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study is to compare the effects of Interactive video balance-based exercise (IVBE)
      intervention and conventional rehabilitation on the balance and functional performance in
      stroke survivors. Fifteen participants will receive Interactive video balance-based exercise,
      while the other half will receive conventional rehabilitation.
    

Detailed description: 
      Thirty individuals with stroke are recruited and allocated to 2 groups in this study. Fifteen
      participants in group A will undergo 30 minutes a day and 3 days a week interactive video
      balance-based exercise intervention for four weeks. Another 15 participants allocated to the
      group B will receive 30 minutes a day and 3 days a week conventional rehabilitation for four
      weeks. Time up go test (TUG), Berg Balance Scale (BBS), Modified Falls Efficacy Scale (MFES),
      Motricity Index (MI), Functional Ambulation Category (FAC) were assessed before and after
      intervention in both groups
    

Intervention name(s): interactive video balance-based exercise; Conventional physiotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interactive video balance-based exercise :10 minutes of warm up exercise, 30 minutes of Interactive video balance-based exercise and 5 minutes of cool down exercise.; conventional physiotherapy: 10 minutes of warm up exercise, 30 minutes conventional physiotherapy and 5 minutes of cool down exercise. Conventional physiotherapy contains rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: interactive video balance-based exercise; conventional physiotherapy
Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is the first clinical trial in Japanese subjects. The study is designed to
      evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of
      PF-03463275 oral controlled release formulation in Japanese and Western male subjects.
    


Intervention name(s): PF-03463275; PF-03463275; PF-03463275; Placebo; PF-03463275; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral single 20 mg dose as two 10mg controlled release tablets; Oral single 40 mg dose as four 10mg controlled release tablets; Oral single 60 mg dose as six 10mg controlled release tablets; Oral single dose as matching placebo; Oral multiple 40 mg doses as four 10mg controlled release tablets for 7 days; Oral multiple doses as matching placebo for 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase1; Pharmacokinetics; Healthy Male; Japanese; Schizophrenia
School Centered Telemedicine Program for Children With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine if using school-based telemedicine for diabetes
      support and education in students with type 1 diabetes in grades K-8 can lead to improvement
      in control of diabetes and improved satisfaction of all caregivers.
    

Detailed description: 
      Subjects, ages 5 to 14 years (grades kindergarten through eighth) were randomized to usual
      care (18 students; 13 schools) or intervention (23 students; 12 schools). Usual care included
      medical visits every 3 months and communication between school nurse and diabetes team as
      needed by phone. The intervention group received usual care plus a telemedicine unit in the
      school nurse office to videoconference between the school nurse, child, and diabetes team
      every month. Hemoglobin A1c and pediatric quality of life were measured every 3 months for 1
      year. Analyses used multilevel modeling.
    

Intervention name(s): telemedicine
Intervention type(s): Other
Intervention description(s): School telemedicine intervention involving school personnel, the child with type 1 diabetes and at least 1 parent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
Condition: Pediatric Heterozygous Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in
      children and adolescents with heterozygous familial hypercholesterolemia
    


Intervention name(s): Atorvastatin; Atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 6-10 years Tanner Stage 1 will be administered 5-mg daily dose of an atorvastatin pediatric tablet formulation. Dose may be doubled if subjects have not attained target LDL (<3.35 mmol/L) after 4-week treatment.; 10-17 years Tanner Stage 2 will be administered 10-mg daily dose of atorvastatin tablet formulation. Dose may be doubled if subjects have not attained target LDL (<3.35 mmol/L) after 4-week treatment.
Intervention MeSH terms: Atorvastatin
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: heterozygous familial hypercholesterolemia (HeFH); atorvastatin; pediatric