bioihbjkbjnl/mcl2 huggingface dataset:
Chlorhexidine Gluconate Cleansing in Preventing Central Line Associated Bloodstream Infection and Acquisition of Multi-drug Resistant Organisms in Younger Patients With Cancer or Undergoing Donor Stem Cell Transplant
Condition: Bacterial Infection; Benign Neoplasm; Malignant Neoplasm; Methicillin-Resistant Staphylococcus Aureus Infection; Myeloid Neoplasm; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Sepsis; Staphylococcal Infections; Leukemia; Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized phase III trial studies chlorhexidine gluconate cleansing to see how well it
      works compared to control cleansing in preventing central line associated bloodstream
      infection and acquisition of multi-drug resistant organisms in younger patients with cancer
      or undergoing donor stem cell transplant. Chlorhexidine gluconate may help reduce bloodstream
      infections and bacterial infections associated with the central line.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine whether chlorhexidine gluconate (CHG) cleansing decreases central line
      associated bloodstream infection (CLABSI) in children with cancer or those receiving an
      allogeneic hematopoietic cell transplantation (HCT).

      SECONDARY OBJECTIVES:

      I. To determine whether CHG cleansing decreases acquisition of multi-drug resistant organisms
      (MDRO: vancomycin resistant enterococci [VRE], methicillin resistant Staphylococcus aureus
      [MRSA], etc.) in children with cancer or those receiving allogeneic HCT.

      II. To determine whether CHG cleansing in children with cancer or those receiving allogeneic
      HCT is associated with cutaneous bacterial isolates with reduced susceptibility to CHG.

      III. To determine whether CHG cleansing decreases positive blood cultures in children with
      cancer or those receiving allogeneic HCT.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive CHG cleansing with topical skin wipes once daily (QD) for 90 days.

      ARM II: Patients receive control cleansing with topical skin wipes QD for 90 days.
    

Intervention name(s): Chlorhexidine Gluconate Skin Cleanser; Laboratory Biomarker Analysis; Mild Soap Skin Cleanser; Questionnaire Administration
Intervention type(s): Procedure; Other; Procedure; Other
Intervention description(s): Given CHG cleansing; Correlative studies; Given control cleansing; Ancillary studies
Other intervention name(s): Skin Cleanser with Chlorhexidine Gluconate; Skin Cleanser with Mild Soap
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Non-interaction Study of Chlorthalidone and Losartan in Fixed Combination, in Healthy Subjects, Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Monocentric study of no pharmacokinetic interaction between chlorthalidone and losartan, with
      an open, randomized, single-dose design with four periods, four sequences and crossover in
      healthy volunteers, under fasting conditions, administered in fixed combination (Test product
      of Laboratorios Silanes, SA de CV) against the individual components administered jointly and
      separately (Higroton® 50, a product of Sandoz, SA de CV and Cozaar® , a product of
      Schering-Plow, SA de CV)
    

Detailed description: 
      The study was designed to recruit 36 healthy subjects, which were randomized for this study
      contemplating losses. All the volunteers whose data allowed at least one comparison to be
      made were included in the corresponding statistical analysis. The objective was to
      statistically compare the bioavailability of chlorthalidone (at normalized dose) and losartan
      potassium, in a non-interaction pharmacokinetic study after single-dose oral administration
      of a product with the fixed combination of active ingredients with respect to the individual
      components administered together and separately in healthy fasting volunteers. As a secondary
      objective, the tolerability of the presentations was evaluated based on the registry of
      adverse events at the end of the four study periods.
    

Intervention name(s): Chlorthalidone (HIGROTON® 50); Losartan (COZZAR®); A1+ A2 Co-administration of Chlorthalidone and Losartan; Chlorthalidone + Losartan Fixed-Dose combination
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets with 50mg of Chlorthalidone, product de Sandoz, S.A. de C.V.; Losartan potassium 100 mg tablet, a product of Schering-Plough, S.A. C.V.; 50mg chlorthalidone + 100 mg losartan potassium; Tablets with fixed combination of Chlorthalidone 25 mg and Losartan Potassium
Other intervention name(s): Chlo; Los; Chlo + Los; FDC
Intervention MeSH terms: Losartan; Chlorthalidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chlorthalidone; Losartan; No-interaction, pharmacokinetics; Fixed-dose combination (FDC)
Evaluation of Program for Length Based Weight Estimation
Condition: Length-based Weight Estimation; Body Weights and Measures
MeSH terms: Body Weight
Study type: Observational

Summary: 
      The purpose of this prospective single center study is to investigate if a developed program
      is more accurate than the anesthesia tape ("Anästhesie-Lineal"). For this study 1000 patients
      are required to collect anonymized data (length, weight, age, anesthesia material used during
      anesthesia) for achieving a power of 80% during statistical analysis. The main hypothesis ist
      that the program has a better accuracy than the anesthesia tape ("Anästhesie-Lineal").
    

Detailed description: 
      This prospective single center study is performed at the university children's Hospital
      zurich. Patients planned for surgery in general anesthesia with intubation, aged 0 to 16
      years and with a body length suitable for the emergency tapes can be included in this study.
      Patient and parental information is performed during the pre-anesthetic visit. After written
      consent the patient will be included. Patient ́s length and weight will be measures earliest
      one day before data collection. Data collection during anesthesia has no influence on the
      daily anesthesia routine and has no impact on patient safety and anaesthesia. Patient's data
      is made anonymous for further inspection. Data is documented in Microsoft Excel and
      statistical analysis calculated with SPSS. 1000 patients are needed for a power of 80%.
      Primary outcome parameter is length based weight estimation, secondary outcome parameters are
      length based age estimation and the correctness of recommended anesthesia material
      (endotracheal tube, laryngeal mask, oropharyngeal mask and face mask). Both tools (program
      and anesthesia tape ["Anästhesie-Lineal"]) will be compared with each other regarding primary
      and secondary outcome parameters.
    

Intervention name(s): Device: Accuracy of a program and the anesthesia tape ("Anästhesie-Lineal")
Intervention type(s): Other
Intervention description(s): Computer based comparison of the two devices based on collected patient data
Intervention MeSH terms: Anesthetics
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pediatric patients planned for elecitve surgery in general anesthesia
      
Keywords: Weight estimation; Patient safety
Effect of Low-carbohydrate/High-fat Diet on Glucose Tolerance and Lipid Profile in Lean, Healthy Women
Condition: Insulin Sensitivity; Weight
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      Intervention studying the effect of a low-carbohydrate/high-fat (LCHF) diet as well as on
      bout of exercise in combination with either a normal diet or a LCHF diet, in relation to
      glucose metabolism, insulin sensitivity, lipid profile and body composition.
    


Intervention name(s): LCHF diet and a bout of exercise
Intervention type(s): Other
Intervention description(s): Low-carbohydrate/high-fat diet; effect on insulin sensitivity, lipid profile, weight and body composition. Participants ingested LCHF diet for three weeks before undergoing an oral glucose tolerance test. The same afternoon the participated in an one hour indoor bicycle training at 75% at HFpeak. The following morning they underwent a new oral glucose tolerance test. Body composition and weight were measured before and after the intervention. Oral glucose tolerance test was also performed before the intervention for baseline. Blood samples were collected before and after the intervention for lipid profile analyses.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Insulin sensitivity; Lipid profile; Body composition; Weight
Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where
      a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily
      dose is administered for women who are at risk of a poor ovarian response in order to
      determine if one dose or the other results in improved cycle outcomes.
    


Intervention name(s): menotropins for injection; urofollitropin for injection
Intervention type(s): Drug; Drug
Intervention description(s): comparison of different dosages; comparison of different dosages
Other intervention name(s): Menopur; Bravelle
Intervention MeSH terms: Menotropins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVF; dose comparison of gonadotrophins; poor responder to ovarian stimulation
Headache Analysis and Intervention
Condition: Headache
MeSH terms: Headache
Study type: Interventional

Summary: 
      Diagnosing and treating posture-related headache (PRH), such as tension-type and cervicogenic
      headache, is seriously hampered because of common features and complex interaction of the
      neurological and musculoskeletal system. Current therapies are therefore not as effective and
      the population of patients with PRH keeps on increasing. The diagnostic as well as the
      therapeutic process need more structure in order to select the most effective treatment;
      thereby contributing to preventive measures. This goal can be achieved through fundamental
      research with a clinically oriented background. Our study starts from a clinical problem,
      with a growing incidence, and is therefore highly relevant. Because sitting-posture seems to
      play an important role in PRH, the first step in the diagnostic process is to analyse
      postural differences between a PRH- and a control-group. In addition, the role of the dura
      mater in the headache-process will be examined. Patients with PRH will be classified in
      homogeneous groups based on these results. In a second phase individual-specific treatment
      programs will be composed. The general treatment-approach of postural abnormalities in the
      past failed because of the heterogeneous patient-populations. Sub-classifying musculoskeletal
      problems has been proven to be successful in the past (O'Sullivan & Dankaerts, non-specific
      low back pain).

      Our study is divided in 2 phases:

        -  phase 1: profile analysis (no intervention, experimental headache-group vs. asymptomatic
           controls)

        -  phase 2: interventional phase (clustered headache-groups, based on the results of phase
           1
    


Intervention name(s): Individual Profile Analysis (Physical therapy Intervention)
Intervention type(s): Other
Intervention description(s): The Individual Profile Analysis consists of the following components:
Analysis of the sitting-posture profile:
o cervical spine, thoracic spine, lumbar spine and pelvis during a longitudinal provoking task (working at a laptop).
Analysis of the dural profile before and after the provoking task:
o Determination of the dural sensitivity by the use of the slump-test
Analysis of the pain profile before and after the provoking task:
Determination of pressure pain sensitivity by the use of pressure algometry
Determination of the influence of pain on the quality of life by the use of the HIT-6 questionnaire
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: posture, sit
Movement Therapy and Childhood Obesity
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The Child health and Sports Center, Meir Medical Center, has an intervention program to treat
      obese children. The program includes physical activity, nutritional intervention and
      behavioral treatment.The emphasis given in the center to physical activity and sport enables
      a strong connection with movement therapy. Movement therapy allows obese children to face and
      cope with the psychological and emotional aspects of obesity.

      The purpose of this study is to evaluate the contribution of the movement therapy
      intervention to our program.
    

Detailed description: 
      Movement therapy is part of the multidisciplinary intervention. Weekly one hour long sessions
      are conducted under the guidance of a certified therapists.

      The meeting includes physical movement aimed to address the emotional world of the obese
      child. Using games, structured exercises and verbal processing.

      At the start and end of the evaluation the children will answer questionnaires to study:

        1. Behavioral questionnaires:emotional state: anxiety, depression, communication,
           self-esteem, quality of life and self-efficacy.

        2. Demographic questions . At the beginning and the end of the program a certified movement
           therapist will observe the children to estimate the change of emotional movement.weight,
           height and BMI are measured regularly in the center.
    

Intervention name(s): movement therapy; exercise plus nutrition
Intervention type(s): Behavioral; Other
Intervention description(s): exercise, nutrition, movement therapy; exercise, nutrition
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; movement therapy; exercise; behaviour
The Effect of Content of Barley Beta-glucans in Bread on Postprandial Blood Sugar
Condition: Glycemic Index
Study type: Interventional

Summary: 
      The effect of content of barley beta-glucans in bread on postprandial blood sugar will be
      measured with open-label crossover study. Study will be conducted in Slovenia on 10-12 adult
      subjects who will test three barley beta-glucan containing bread formulations (food) in
      comparison with a reference white bread. Objective of the study is to investigate the
      influence of the content of barley beta-glucan in bread on glycaemic index (incremental area
      under the curve (IAUC) for the blood glucose response curve for barley beta-glucan containing
      breads in comparison to reference white bread.
    


Intervention name(s): REFERENCE: white bread - BGL0 [RP]; TEST: b-glucan enriched bread - BGL2 [IP1]; TEST: b-glucan enriched bread - BGL3 [IP2]; TEST: b-glucan enriched bread - BGL4 [IP3]
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Determination of glycemic response after consumption of BGL0.; Determination of glycemic response after consumption of BGL0.; Determination of glycemic response after consumption of BGL0.; Determination of glycemic response after consumption of BGL0.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glycemic Index; glycemic response; bread; barley; beta-glucans; glucose level; continous glucose monitoring
Replication of the INSPIRE Trial in Healthcare Claims Data
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as is possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates according to standard practice. Investigators
      assume that the RCT provides the reference standard treatment effect estimate and that
      failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims
      data for replication for a range of possible reasons and does not provide information on the
      validity of the original RCT finding.
    

Intervention name(s): Tiotropium; salmeterol-fluticasone
Intervention type(s): Drug; Drug
Intervention description(s): Tiotropium dispensing claim is used as the reference group.; Salmeterol/Fluticasone dispensing claim is used as the exposure group.
Intervention MeSH terms: Fluticasone; Tiotropium Bromide; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, propensity score matched retrospective
        cohort study design comparing tiotropium to salmeterol. The patients will be required to
        have continuous enrollment during baseline period of 180 days before initiation of SFC or
        tiotropium inhalers (cohort entry date).
Electromagnetic Field Versus Diclofenac Drugs on Primary Dysmenorrhea
Condition: Electromagnetic Field; Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      Electromagnetic field versus diclofenac drugs on primary dysmenorrhea: Arandomized controlled
      trial in the Egyptian women
    

Detailed description: 
      Background: Primary dysmenorrhea is one of the most common complaints of women and is also
      the most common gynecological problem worldwide. These cramps are recurrent and 90%
      adolescent girls and about 50% women suffer from it. Purpose of the study: to determine which
      is more effective in alleviating primary dysmenorrhea; pulsed electromagnetic field or
      diclofenac drugs. Methodology: The study was a randomized, double-blinded trial, fifty adult
      females participated in this study, were divided randomly into two groups equal in numbers:
      group (A) received pulsed electromagnetic field applied on pelvic region, 3 times per week
      for 3 months, 20 minutes per day and group (B) received diclofenac tablets, 50 mg only with
      onset of menstrual pain. All participants in both groups (A and B) were assessed pre- and
      post-treatment through measuring progesterone level in the blood, assessment of pain using
      visual analogue scale and physical as well as psychological symptoms by using menstrual
      symptom questionnaire.
    

Intervention name(s): Pulsed electromagnetic field; diclofenac tablets; Visual analogue scale; Progesterone blood level; Menstrual symptom questionnaire
Intervention type(s): Device; Drug; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): EASY Qs portable (by ASA, Italy); drugs; a graphic rating scale; blood test; questionnaire
Intervention MeSH terms: Diclofenac; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dysmenorrhea; Pulsed electromagnetic field; Diclofenac
Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      A clinical study explores the safety and efficacy of montelukast and to compare the safety
      and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients
      when they are used in conjunction with inhaled steroids.
    


Intervention name(s): montelukast; Theophylline
Intervention type(s): Drug; Drug
Intervention description(s): montelukast 5 mg QD 4-weeks.; Theophylline 100 to 200 mg BID 4-weeks.
Other intervention name(s): MK0476
Intervention MeSH terms: Theophylline; Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment