bioihbjkbjnl/mcl2 huggingface dataset:
Delivery Pain and Postpartum Comfort
Condition: Labor Pain; Hydrotherapy; Acupressure; Postpartum Period
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      In this study was aimed that acupressure applied on the BL32 point and shower application
      reduced the intensity of labor pain experienced by the pregnant women in the active phase of
      labor and increased their postpartum comfort
    

Detailed description: 
      Acupressure and shower are methods that can help reduce pain severity. This study thus aims
      to determine the effects of acupressure and shower on labour pain and postpartum comfort.
      This study was a randomized controlled trial (RCT). This study was the control group
      consisted of 40 pregnant women, while the experimental groups (acupressure and shower)
      consisted of 80 pregnant women in total. The experimental groups received routine labour care
      and either acupressure or showers upon reaching three cervical dilations (4-5, 6-7 and 8-10
      cm). The control group only received routine labour care. A maternal information form (MIF),
      the Visual Analog Scale for Pain (VASP) and the Postpartum Comfort Questionnaire (PPCQ) were
      used to collect data. CONSORT checklist was used to report the current study.
    

Intervention name(s): Acupressure; Shower
Intervention type(s): Other; Other
Intervention description(s): A researcher sat behind the women to comfortably access the sacral area and be in the appropriate position. The researcher then applied deep rotational pressure on the BL32 points until her nail bed colour changed to prevent any discomfort in the participants; During uterine contractions, these participants took a shower while standing, with a researcher on hand to assist her (average time: 20 minutes). The water's temperature was between 22°C and 26°C.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The randomized controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: labor pain; shower; acupressure; midwife; postpartum comfort
Pharmacogenetics of VOD in Children With HSCT
Condition: Cancer
Study type: Observational

Summary: 
      This project aims to identify common pharmacogenetic biomarkers predisposing children with
      cancer to develop hepatic VOD during their cancer treatment including HSCT. The impact of VOD
      occurrence and significant biomarkers will also be evaluated on outcome at day 100 and one
      year after HSCT. It should help to highlight factors that can contribute to the initiation of
      hepatic VOD.

      Understanding mechanisms of this toxicity and to know individual parameters of disease
      susceptibility becomes an important issue in the care of these children. The ultimate goal of
      research in this area would be to develop a personalized predictive medicine and, hopefully,
      prevent the occurrence of VOD from a therapeutic adaptation to each patient according to his
      pharmacogenetic profile (adapted prophylaxis, dose adjustment, drug combinations ...). A
      prospective identification of patients at risk of hepatic VOD will increase the safe use of
      anticancer.
    

Detailed description: 
      Hematopoietic stem cells transplantation (HSCT) in children with cancer is source of
      veno-occlusive disease (VOD). This complication is unpredictable and serious by involving the
      vital prognosis of the child. In addition, this complication may affect the patient's quality
      of life and have serious long-term sequelae. The incidence varies from 15 to 60% and the
      mortality is greater than 60% after severe VOD. The risk factors of occurrence of these
      complications are, to date, unknown except for a susceptibility to some therapeutic
      (busulfan, radiotherapy ...). Pharmacogenetic aspects of hepatic VOD susceptibility are
      supposed and targeted screening supported this hypothesis. But pharmacogenetic predisposition
      to VOD was never explored with as many polymorphisms and considering the whole exome.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        This study concerns children with cancer aged less than 18 years treated for their first
        HSCT between 2000 and 2011 in France.
Development of Algorithms to Predict Hemodynamic Instability
Condition: Sudden Cardiac Death
MeSH terms: Death, Sudden, Cardiac; Death
Study type: Observational

Summary: 
      Hemodynamic monitoring in hospitalized patients is crucial since in clinical practice
      unexpected deterioration of cardiovascular function remains a serious problem and an
      important cause of death. Novel perspectives in reflex testing of the autonomic nervous
      system might be useful to protect some patients from cardiovascular events by detecting
      cardiovascular deteriorations. In addition, standard pulse oximetry in low acuity settings is
      nowadays predominately used to monitor peripheral oxygen saturation. Of note, there is
      evidence that additional analyses of pulse wave characteristics might be a valuable source of
      information to generate additional insights into the cardiorespiratory status of the patient.
      Herein, we aim to develop novel algorithms in order to protect in-hospital patients from
      cardiovascular events in consequence of hemodynamic instability in the future.
    

Detailed description: 
      70 datasets from hospitalized patients will be acquired in order to characterize the
      functional status of the autonomic nervous system as well as hemodynamics during baseline and
      during standard procedures including physical exercise testing and head-up tilt table
      testing.

      Autonomic reflex testing:

        -  Heart Rate Characteristics

        -  Heart Rate Variability

        -  Heart Rate Turbulence

        -  Blood Pressure Variability

        -  Baroreflex Sensitivity

        -  Hyperoxic Chemoreflex Sensitivity

      Hemodynamic Monitoring:

        -  Heart Rate Trends

        -  Blood Pressure Trends

        -  Pulse Wave Characteristics

        -  Cardiac Output

        -  Peripheral Vascular Resistance

        -  Context information
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients being at risk of sudden cardiac death
      
Keywords: autonomic nervous system
Outpatient Characterization of the Variability of Insulin Secretory Parameters in the Meal Tolerance and the Maximal Stimulation Tests of Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      A multi-year clinical study to improve tools for measuring the function of insulin-producing
      beta cells in people with type 2 diabetes mellitus.
    

Detailed description: 
      A three-year observational study to standardize the meal tolerance and maximum stimulational
      tests for measuring beta cell function in the clinical setting. It also aims to improve
      methods for the early prediction of the long-term response to an intervention and for
      identification of patients at risk for rapid beta cell function deterioration, thereby
      enabling future clinical studies that examine diabetes progression.
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        obese individuals with type 2 diabetes mellitus
      
Keywords: type 2 diabetes; beta cell function; meal tolerance test; maximum stimulation test; method standardization; insulin secretion; prediabetes; insulin sensitivity
Pexy Versus Non-pexy for Full Thickness Rectal Prolapse
Condition: Rectal Prolapse
MeSH terms: Rectal Prolapse; Prolapse
Study type: Interventional
Phase: Phase 3

Summary: 
      No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external
      full-thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that
      recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy.

      Method: This is a multicenter randomized non-inferiority trial. Eligible patients were
      randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal
      surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery
      with mobilization and pexy. Sigmoid resection was not randomized and was added in the
      presence of constipation. The endpoint was recurrence rates defined as presence of external
      FTRP after surgery. A pre-RCT meta-analysis suggested a sample size of 251 patients based on
      a 15% expected difference in the 5-year cumulative recurrence rate. Recurrence-free curves
      will be generated and compared using the Kaplan-Meier method and log-rank test, respectively.
      A Bonferroni adjustment was used. An adjusted p value of <0.01 was considered significant.
    


Intervention name(s): sacral rectopexy with sutures or meshes; full rectal mobilization from the sacrum without sacral rectopexy
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Rectal prolapse; mesh; recurrence
Safety and Efficacy Study of Roxadustat to Treat Anemia in Patients With Chronic Kidney Disease, on Dialysis.
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of roxadustat compared to
      epoetin alfa for the treatment of anemia in chronic kidney disease patients on dialysis.
    

Detailed description: 
      This is a Phase 3, multicenter, randomized, open-label, active-controlled study to evaluate
      the efficacy and safety of roxadustat compared to epoetin alfa for the treatment of anemia in
      dialysis patients. Patients on hemodialysis (HD) or peritoneal dialysis (PD) who have been
      treated with an erythropoietin analogue or have an indication for treatment with an
      erythropoietin analogue will be evaluated for eligibility and randomized at a 1:1 ratio to
      treatment with roxadustat (with discontinuation of prior erythropoietin analogue therapy) or
      to an active-control group treated with epoetin alfa
    

Intervention name(s): Roxadustat; Epoetin alfa
Intervention type(s): Drug; Drug
Intervention description(s): Roxadustat will be administered orally three times a week (TIW) to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.; Epoetin alfa will be administered TIW consistent with approved prescribing information for epoetin alfa to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal,; CKD,; Epoetin alfa,; Roxadustat,; dialysis,; anemia
Cardiovascular Effects of GLP-1 Receptor Activation
Condition: Obesity; PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 4

Summary: 
      This project tests the principle hypothesis that stable glucagon like peptide-1 (GLP-1)
      analogues have specific GLP1R-dependent beneficial effects on vascular endothelial function,
      fibrinolysis and inflammation in obesity that exceed the benefits of weight loss, and that
      genetic or other individual factors that modulate GLP1R sensitivity can modify the effect of
      these analogues on cardiovascular risk.
    


Intervention name(s): Liraglutide; Sitagliptin; hypocaloric diet; Placebos; Exendin (9-39)
Intervention type(s): Drug; Drug; Other; Drug; Drug
Intervention description(s): subcutaneous liraglutide daily; oral sitagliptin daily; Reduced calorie intake to achieve weight loss.; Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.; All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
Intervention MeSH terms: Sitagliptin Phosphate; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Neoadjuvant Chemoradiation With Bevacizumab for Chinese Rectal Cancer Patients
Condition: Rectal Adenocarcinoma
MeSH terms: Adenocarcinoma; Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the efficacy and safety of the combination of
      cytotoxic chemotherapy (Oxaliplatin and 5Fu) with bevacizumab concomitantly with radiotherapy
      as neoadjuvant treatment for patients with locally advanced but resectable rectal
      adenocarcinoma.
    

Detailed description: 
      Primary endpoint: Pathological Complete Response Rate (pCR)

      Secondary endpoint: Time to Relapse, disease free survival, overall survival and safety data
    

Intervention name(s): Bevacizumab; Oxaliplatin; 5-FU; Radiotherapy
Intervention type(s): Drug; Drug; Drug; Radiation
Intervention description(s): Bevacizumab 5mg/m2 D1,D15,D29,D43;; Oxaliplatin 85mg/m2 D1,D57; Oxaliplatin 85mg/m2 biweekly * 6 doses 3-4 weeks after radical resection; 5-FU 2800mg/m2 civ 48 hours D1,D57; 5-FU 2800mg/m2 civ 48 hours biweekly*6 doses 3-4 weeks after radical resection; 5-FU 200mg/m2/day civ D15-19,D22-26,D29-33,D36-40,D43-47;; 2GY daily *20次
Other intervention name(s): Avastin
Intervention MeSH terms: Bevacizumab; Oxaliplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rectal cancer; Adenocarcinoma; Bevacizumab; Chemoradiation
Transcranial Direct Current Stimulation in Autistic Spectrum Disorder
Condition: Autistic Disorders Spectrum
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      To understand the changes in the resting electroencephalogram (EEG) brain networks of
      children and adolescents with autistic spectrum disorder (ASD) induced by transcranial direct
      current stimulation (tDCS), we asked two questions. First: how can tDCS modulate the
      expression of neural network dynamics? Second: how can tDCS modulate functional connections
      at specific frequencies? We hypothesized that the tDCS mechanism results in increased
      cortical frequencies in the areas under the anode, which may reflect an increase in synaptic
      connectivity, and that this tDCS-related increase changes connection profiles at specific
      frequencies important for ASD, indicating improvement in symptoms. To verify this
      improvement, the researchers used the Autism Treatment Evaluation Checklist (ATEC) after an
      intervention, comparing baseline scores with post-treatment scores.
    


Intervention name(s): DLPFC-R (F4) TDCS; DLPFC-L (F3) and DLPFC-R (F4) TDCS; sham-tDCS
Intervention type(s): Device; Device; Device
Intervention description(s): direct current brain stimulation- The study was developed through a triple-blind, crossover, randomized, placebo-controlled clinical trial (dummy tDCS). Participants were randomized into three groups receiving unilateral tDCS in DLPFC-L F3 (Block A), combined tDCS in DLPFC-L (F3) and DLPFC-R (F4) simultaneously (Block B) or sham-tDCS (Block C) with equal electrode configuration guaranteed blindness. After the procedures, each participant received the following intervention in the order ABC, BCA or CAB with a period of 1 week between each one. Each block took 3 weeks, organized into: 1) Assessment; 2) Application of stimulation; 3) Reassessment and washout week. Adding 1 more week of final evaluation, the study totaled the period of 10 weeks. During this period, patients were instructed to continue their behavioral/educational treatment and medication routines.; DLPFC-L (F3) and DLPFC-R (F4) (Bock B); sham-tDCS (Block C) with equal electrode configuration guaranteed blindness
Other intervention name(s): nibs; NIBS
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Tdcs; EEG
Gastric Layering and Monitoring II
Condition: Infant Formula
Study type: Interventional

Summary: 
      Rationale: Results from a previous study suggest that gastric layer formation, which is
      caused by emulsion instability as a result of gastric acidification/digestion, is different
      between breastmilk and infant formula. The current study focusses on further understanding of
      these differences by investigating the effect of formula composition.

      Objective: To investigate the effect of infant formula composition on intragastric behavior,
      gastric emptying and postprandial plasma parameters.

      Study design: Double-blind cross-over study with two treatments.

      Study population: 20 healthy normal-weight males, aged 18-45 y.

      Intervention: After an overnight fast, participants will drink sufficient volume of one of
      the two IFs which differ in composition. Gastric content will be monitored using Magnetic
      Resonance Imaging (MRI). MRI scans will be done and blood samples will be taken for
      subsequent analyses at baseline and post prandially .

      Main study parameters/endpoints: The primary outcome is gastric behavior. Secondary outcomes
      are total gastric content volume over time and blood parameters.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: The risks associated with participation are low, as both phlebotomy and MRI are
      eminently safe medical techniques. In addition, the test formula are safe. Each participant
      will participate in 2 sessions, which require an overnight fast, 9 blood withdrawals (in
      total 120 mL per visit) and multiple MRI scans over a period of approximately 2 hours. These
      measurements are non-invasive and carry minimal risk. The burden of the sessions is most
      likely related to mild discomfort as they have to lie still in the MRI for two hours. This
      will be minimized by the soft mattress on the bed of the MRI, leg rest and a pillow
      underneath the head.
    


Intervention name(s): Infant Formula
Intervention type(s): Other
Intervention description(s): Two infant formulas differing in composition
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized cross-over trial
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Gastric behaviour; Nutrient absorption
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Fatigue
Study type: Interventional
Phase: Phase 3

Summary: 
      Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining
      regular dietary counseling and tailored physical activity is associated with reduced
      cancer-related fatigue and can improve quality of life and body weight control. We propose to
      conduct a randomized controlled trial which purpose is to evaluate the effect of an
      intervention combining physical exercise and nutritional therapeutic education on
      cancer-related fatigue. To gain behavioral change towards PA and nutrition habits,
      interventions will take place within hospitals, on the same days of adjuvant treatments.
    

Detailed description: 
      Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining
      regular dietary counseling and tailored physical activity is associated with reduced
      cancer-related fatigue and can improve quality of life and body weight control. We propose to
      conduct a randomized controlled trial which purpose is to evaluate the effect of an
      intervention combining physical exercise and nutritional therapeutic education on
      cancer-related fatigue. To gain behavioral change towards PA and nutrition habits,
      interventions will take place within hospitals, on the same days of adjuvant treatments.
    

Intervention name(s): Tailored program of PA and nutritional counseling
Intervention type(s): Behavioral
Intervention description(s): Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Comprehensive Adjuvant Care; Cancer-related fatigue; Therapeutic patient education; Physical Activity; Nutritional counselling; Rehabilitation