bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Exercise on Vitamin d in Obese
Condition: Obesity; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The aim of the current study was to investigate the effect of exercise-induced lipolysis on
      vitamin D status in obese children. Two types of exercises that have different effects on
      lipolysis were used. Lipolysis was assessed via monitoring the level of plasma level of the
      free fatty acids and glycerol. Vitamin D was assessed through 25 (OH)D plasma levels.
    

Detailed description: 
      vitamin D status was monitored through 25 (OH)D levels, and the lipolysis status via the
      plasma level of the free fatty acids and glycerol immediately after the exercise. All
      subjects who participated in the study were under supervision for controlling the fat
      contents and vitamin D in their food for one week prior to the exercise. the subjects fasted
      eight hours before the exercise. All the exercises were performed between 9 am and 11 am.
    

Intervention name(s): Endurance exercise; Resistance exersises.
Intervention type(s): Other; Other
Intervention description(s): Treadmill training at moderate intensity.; Resistance exercises using the 10 repetition maximum.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 40 obese children who suffered from vitamin d deficiency were randomly assigned into three groups. group I (15 children) received endurance exercises and group II (15 children) received endurance exercises preceded by resistance exercises which have a stronger lipolytic effect. group III (10 children) acted as a control group.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Opioid Reduced Anesthesia With Parasternal CATheters on Postoperative Delirium After Cardiac Surgery
Condition: Cardiac Disease
MeSH terms: Delirium; Emergence Delirium; Heart Diseases
Study type: Observational

Summary: 
      PostOperative Delirium (POD) is the most common neuropsychiatric complication following
      cardiac surgery and may be related to morphine consumption. PostOperative Delirium (POD)
      prolongs hospital and intensive care unit (ICU) length of stay (LOS) and increases morbidity
      and mortality. No study has been conducted to demonstrate the effect of regional anesthesia
      using catheters inserted before sternotomy.
    

Detailed description: 
      This study investigate the effect of an enhanced recovery protocol using regional anesthesia
      on PostOperative Delirium (POD) onset.
    

Intervention name(s): collection of datas
Intervention type(s): Other
Intervention description(s): collection of datas:
Post-operative occurrence (within the first 48 hours after extubation) of post-operative delirium via the CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) scale result
Post-operative hypoxemia defined as a PaO2/FiO2 ratio < 300 in the first 48 hours after extubation
reflex ileus defined as the absence of gas and/or matter in the first 48 hours after extubation,
total morphine consumption in the first 48 hours after surgery
pain at 24 hours and 48 hours after surgery
post-operative nausea and vomiting, major complications (neurological, respiratory, cardiac, infectious)
mortality 30 days after surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Scheduled Cardiac Surgery for Coronary Artery Bypass Grafting or Valvular
        Sternotomy in Patients Aged 18 to 85 Years will be included.
      
Keywords: Cardiac surgery; postoperative delirium; regional anesthesia; enhanced recovery after surgery
Safety and Efficacy of Two Vaginal Products Versus Placebo in Patients With Vaginal Discomfort
Condition: Vulvodynia
MeSH terms: Vulvodynia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of two vaginal products compared with that
      of placebo to determine if the two products are better than placebo in the relief of vaginal
      discomfort.
    


Intervention name(s): Lidocaine/Diphenhydramine; lidocaine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): semi solid, twice weekly, 4 months; semi solid, twice weekly for 4 months; semi solid, twice weekly for 4 months
Intervention MeSH terms: Diphenhydramine; Promethazine; Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Weekly Paclitaxel With or Without Pazopanib in Platinum Resistant or Refractory Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and activity of adding pazopanib to
      weekly chemotherapy with paclitaxel for patients with ovarian cancer that is resistant or
      refractory to treatment with platinum based therapy.
    


Intervention name(s): paclitaxel; pazopanib
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg/m2 IV days 1, 8, 15 every 28 days; orally, 800 mg orally daily
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: platinum resistant; platinum refractory
Novel Preoperative Score Predicting Outcome Following Liver Resection
Condition: Serious Complications Following Liver Resection
Study type: Observational

Summary: 
      To develop and validate a score to predict serious complications following liver resection
      using pre-operative risk factors.
    

Detailed description: 
      Liver surgery is associated with a substantial rate of complications. Early identification of
      patients at risk of serious complications is important in order to adapt therapeutic
      strategies and to improve quality. The purpose of this study is to develop and validate a
      score to predict serious complications following liver resection using pre-operative risk
      factors.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        HPB center Zurich, Switzerland
      
Keywords: Development; Validation; Prediction Score; Complication; Liver resection; develop and validate a score to predict serious complications following liver resection using pre-operative risk factors.
Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
Condition: Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an ADME study. Human radiolabeled mass balance studies are performed as part of drug
      development to obtain information about the absorption, distribution, metabolism, and
      excretion (ADME) of a study treatment. The goals of human ADME studies include the assessment
      of absorption, distribution, routes and rates of excretion, mass balance, and metabolite
      profile and identification.
    


Intervention name(s): BMS-986177
Intervention type(s): Drug
Intervention description(s): An orally administered anticoagulant to prevent and treat thromboembolic events
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Evaluation Report of the Urea / Urine Creatinine as a Marker of Nutritional Status Predictive of ICU Care Associated Infections
Condition: Brain Injury; Malnutrition
MeSH terms: Brain Injuries; Malnutrition
Study type: Observational

Summary: 
      Malnutrition is defined by an energy supply deficit, protein, macro-molecules or
      micro-nutrients, resulting from an imbalance between nutrient intakes and metabolic needs of
      the body. It concerns 40 to 60% of patients upon entry into resuscitation and influences
      their prognosis. Studies over the past decade have shown that nutritional deficiency
      increases the morbidity and mortality in intensive care.

      Several clinical and biological parameters were evaluated as markers of malnutrition,
      including the ratio of urea / urine creatinine.

      The report would identify patients in a state of malnutrition, to optimize their nutritional
      care.

      This setting is easy to obtain in all patients by simple urine collection unlike other
      clinical and biological criteria of resuscitation malnutrition assessment.

      This ratio of urea / urien creatinine would optimize energy intake of critically ill
      patients, for which nutritional management methods are widely debated.
    

Detailed description: 
      At present, many clinical studies have shown a link between malnutrition and infectious
      complications in intensive care particularly because of immune disorders.

      Many studies testing different nutritional strategies used as the main criterion infectious
      complications.

      So this is a robust standard, well documented in the literature as a reflection of
      malnutrition in intensive care, and we also want to use in our study.

      In a pilot study in the surgical ICU of the Hotel-Dieu report the urea / creatinine urine as
      a biomarker of poor outcome of nutritional status in the ICU seems extremely discriminating
      in predicting the existence of nosocomial infection.

      Furthermore the kinetics of the relationship between the intake and the 5th day of
      resuscitation, also appears to be relevant in predicting the occurrence of nosocomial
      infection.

      Surgical ICU of the Hotel-Dieu proposes to conduct a multicenter study to confirm the
      relationship between the ratio of urea / creatinine urine, malnutrition marker, and
      nosocomial infections (NI) in intensive care.

      Primary objective:

      To evaluate the predictability of the ratio of urea / creatinine urinary J5 on the occurrence
      of nosocomial infection in intensive care.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients hospitalized in ICU for severe brain injury
IMPACT OF PAMPHLET ON THE KNOWLEDGE OF HEALTH EFFECT OF SMOKING
Condition: Tobacco Use Cessation
Study type: Interventional

Summary: 
      Tobacco smoke is one of the most preventable cause of mortality and morbidity worlwide, this
      study is conducted to compare the knowledge of the health effects of smoking among
      undergraduates exposed and those not exposed to educational pamphlet. This is designed as a
      randomized clinical trial among 390 undergraduate in University of Benin Edo State Nigeria.
      Data collection tool was an interviewer-administered questionnaire. Data obtained would be
      subjected to regression statistics using IBM SPSS version 21.0. The expected outcome will be
      a veritable tool in tobacco cessation model.
    


Intervention name(s): PAMPHLET
Intervention type(s): Behavioral
Intervention description(s): EXPOSURE TO PAMPHLETS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Study To Evaluate The Pharmacokinetic, Safety And Tolerability Of Single Or Multiple Subcutaneous Doses of Recifercept
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single center, randomized, parallel group, repeated dose study of recifercept
      (Cohort 1 and Cohort 2) or placebo (only in Cohort 1) in approximately 18 healthy
      participants, using 2 cohorts (N = 9) at two dose levels of recifercept.
    


Intervention name(s): Recifercept; Placebo
Intervention type(s): Drug; Other
Intervention description(s): recifercept powder for solution for injection; solution for injection
Other intervention name(s): PF-07256472
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacodynamic Effects, Safety and Tolerability of Cilobradine, to Healthy Male and Female Volunteers, With an Intra-individual Comparison to Moxifloxacin in a Subset of Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT
      analysis of ECGs), and pharmacokinetic parameters
    


Intervention name(s): Cilobradine, low, film-coated tablets; Cilobradine, high, film-coated tablets; Placebo, film-coated tablets; Moxifloxacin, film-coated tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Liraglutide In Overweight Patients With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the effects of liraglutide (a drug used to treat type
      2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to
      insulin.
    


Intervention name(s): liraglutide; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dose-finding Study for the Combination of DMT and Harmine in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to compare corresponding inter- and intraindividual
      pharmacokinetic and pharmacodynamic profiles including assessments of safety & tolerability.
    

Detailed description: 
      Participants will undergo a series of six study days with varying doses of DMT and Harmine.
      The intervention is embedded in controlled environment and continuous psychological support.
      Pharmacokinetic and pharmacodynamic assessments are obtained over the course of 24 hours on
      each study visit to estimate dose-exposure relationship and drug-drug-interaction.
      Additionally, the occurrence of adverse events will be closely monitored throughout the whole
      study.
    

Intervention name(s): Dimethyltryptamin (DMT) & Harmine
Intervention type(s): Drug
Intervention description(s): Six varying doses of a fixed-combination formulation of Dimethyltryptamin (DMT) and harmine
Other intervention name(s): RE01
Intervention MeSH terms: Harmine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Each participants will be randomized into one of two sequences. Each sequence consists of six study days with a minimum of 1 day between each study day. The differences between the sequences are a) the order of dosages administered to minimize confounding effects through expectancy and b) a study day containing only one of the two active ingredients, thus covering each combination in a factorial, cross-over design.
Masking: Single (Participant)
Primary purpose: Other
Polymorphids an mRNA Expression in Obese Genes
Condition: Polymorphism; mRNA Expression
Study type: Observational

Summary: 
      Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing
      laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP).

      Are there any difference in polymorphids and/or mRNA expression in genes significant for
      developing obesity, between normal weight and obese individuals, with or without diabetes typ
      2 .

      Are there any difference in polymorphids and/or mRNA expression in different types of fat
      tissue
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Tree groups; group I: diabetes type II with BMI>35 Group II: no diabetes BMI>35 Group III:
        no diabetes BMI 18-27
      
Biospecimen description: 
      biopsys; Fat from oment, thigh and abdomen
Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the Valganciclovir Hydrochloride Tablets 450 mg of Dr. Reddy's
      Laboratories Limited, India and Valcyte® (Valganciclovir HCl) tablets 450 mg of Genentech USA
      Inc., Group of Roche, South San Francisco in healthy, adult, human subjects under Fed
      conditions.
    

Detailed description: 
      Open label, balanced, randomized, two-treatment, two-period, two-sequence, cross over, single
      dose, oral bioequivalence study of Valganciclovir Hydrochloride Tablets 450 mg under Fed
      conditions.
    

Intervention name(s): Valganciclovir Hydrochloride
Intervention type(s): Drug
Intervention description(s): Valganciclovir Hydrochloride Tablets 450 mg
Other intervention name(s): Valcyte
Intervention MeSH terms: Valganciclovir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between Oxomemazine, Guaifenesin and Potassium Iodate Versus Guaifenesin Monotherapy in Acute Cough Treatment
Condition: Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is evaluate if efficacy of a combination dose of oxomemazine,
      guaifenesin and potassium iodate is superior than guaifenesin monotherapy in acute cough
      treatment.
    

Detailed description: 
      STUDY DESIGN

        -  Open-label, superiority, prospective, parallel group, intent to treat trial

        -  Experiment duration: 7 days

        -  3 visits (days 1, 2 and 7)

        -  Reduction cough symptoms

        -  Adverse events evaluation
    

Intervention name(s): Syrup of oxomemazine, guaifenesin and potassium iodate; Syrup of guaifenesin
Intervention type(s): Drug; Drug
Intervention description(s): 5ml each 4 hours; 5ml each 4 hours
Intervention MeSH terms: Potassium iodate; Phenylpropanolamine; Guaifenesin; Chlorpheniramine, phenylpropanolamine drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cough; symptoms; cold; flu
Removal of Surgical Staples After Cesarean Delivery. Randomized Control Trial.
Condition: Cesarean Section; Wound, Infection (Following Delivery)
Study type: Interventional

Summary: 
      The optimal choice of skin closure at cesarean delivery has not yet been determined. This
      study aim to study the wound complications and scar healing after Surgical staples removal at
      postoperative day 4 and day 8 .

      A randomized control trial.
    

Detailed description: 
      A randomized controlled trial in which pregnant women undergoing a scheduled Elective
      cesarean delivery were assigned to skin closure with surgical staples and were randomly
      assigned to the day of removal of surgical staples. Postoperative day 4 VS. Postoperative day
      8 .

      Outcome assessors were blinded to group allocation. Scars will be evaluated after 8 weeks.
      Primary outcome measures is Patient and Observer Scar Assessment Scale (POSAS) scores.
      Secondary outcome measures are complications of surgical site infection (SSI) or wound
      disruption (hematoma or seroma).

      A group of 104 women is needed in order to achieve a clinically signiﬁcant effect with a
      power of 80%.
    

Intervention name(s): Removal of surgical clips at day 4 post operative vs day 8 post operative; Elective cesarean delivery
Intervention type(s): Other; Procedure
Intervention description(s): Removal of surgical clips at day 4 post operative vs day 8 post operative; non emergent elective cesarean delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Effectiveness of Two Different Doses of BI 1026706 on the Overall Peak-to-Peak (PtP) N2/P2-component Amplitude of Laser (Somatosensory, Radiant-heat) Evoked Potentials (LEP) in UVB(Ultraviolet)-Irradiated Skin in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To investigate the influence of different doses of BI 1026706 on the primary endpoint
           (PtP-amplitude LEP in UV skin) compared to placebo.

        -  The comparison of both doses of BI 1026706 to celecoxib in the UVB treatment.

        -  Comparison of both doses of BI 1026706 to placebo and pregabalin in the capsaicin
           treatment

        -  Exploration of the pharmacokinetics of BI 1026706

        -  Exploration of safety and tolerability of BI 1026706
    


Intervention name(s): Placebo to BI 1026706; Pregabalin; BI 1026706; Celecoxib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo tablet; Pregabalin hard capsule; BI 1026706 oral solution; Celecoxib hard capsule
Intervention MeSH terms: Celecoxib; Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
ALiskiren or Losartan Effects on bioMARKers of Myocardial Remodeling
Condition: Hypertension; Left Ventricle Hypertrophy
MeSH terms: Hypertension; Hypertrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess efficacy of aliskiren for reducing circulating levels
      of biomarkers of left ventricular (LV) remodeling associated with LV hypertrophy (LVH) in
      hypertensive patients.
    

Detailed description: 
      Blood pressure was measured 10 weeks after starting treatment (visit 3). All patients who did
      not achieve the required blood pressure (<140/90 mmHg) after 8 weeks of treatment at the
      maximum doses of study medication were given 5 mg of amlodipine in addition to the study
      medication in order to reach the required BP (<140/90 mmHg).

      The patient's blood pressure was assessed at visit 4 (week 18) and if it was still not at the
      required level (<140/90 mmHg), the dose of amlodipine was increased to 10 mg.

      Blood pressure was again assessed at visit 5 (week 26) and if the required values had not
      been reached (<140/90 mmHg), a 12.5 mg dose of hydrochlorothiazide (HCTZ) was prescribed
    

Intervention name(s): Aliskiren; Losartan; Amlodipine; Hydrochlorothiazide (HCTZ)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Aliskiren 300 mg film coated tablets; Losartan 100 mg tablets; Amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved.; HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (<140/90 mmHg) had not been reached.
Other intervention name(s): Rasilez
Intervention MeSH terms: Losartan; Amlodipine; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aliskiren; hypertension; concentric LVH; LV remodeling; LVMI; biomarkers; PICP; CT-1; MMP-1; TIMP-1; AnxA5; Aldosterone; Essential hypertension with concentric left ventricle hypertrophy