bioihbjkbjnl/mcl2 huggingface dataset:
Intensive Care Program for Youth With Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study was to determine the ability of a family-focused, office-based
      intervention to improve medical and behavioral outcomes for children and adolescents with
      type 1 diabetes.
    


Intervention name(s): Care Ambassador Intervention; Psychoeducational Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.; A psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing "diabetes burnout".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; hemoglobin A1c; family; involvement; responsibility; conflict; quality of life; children
Trial of Telmisartan 80 mg/HCTZ 12.5 mg and Telmisartan 40 mg/HCTZ 12.5 mg in Patients With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to assess the safety and efficacy of 52 weeks of open-label
      treatment with the fixed dose combination of telmisartan 80 mg plus HCTZ 12.5 mg and
      telmisartan 40 mg plus HCTZ 12.5 mg in patients with essential hypertension.
    

Detailed description: 
      This is a multi-centre study with three centres participating with a target of 30 to 90
      patients entering the maintenance period and 20-60 patients completing long-term treatment
      per centre. The recruitment period will be about three months from the start of the study.

      Study Hypothesis:

      The primary objective of this study is to demonstrate the long-term safety of a fixed dose
      combination of telmisartan/HCTZ fixed-dose combination treatment. This study has no control
      group; therefore, no hypothesis testing will be performed.

      Comparison(s):

      This study has no control group.
    

Intervention name(s): Telmisartan 40 mg/HCTZ 12.5 mg; Telmisartan 40 mg; Telmisartan 80 mg/HCTZ 12.5 mg
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Telmisartan; Hydrochlorothiazide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Asthma Relapse After Discharge From Emergency
Condition: Asthma
MeSH terms: Asthma; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the Symbicort® Turbuhaler® to both Pulmicort®
      Turbuhaler® and Bricanyl® Turbuhaler® for the treatment of asthma after discharge from the
      emergency room
    


Intervention name(s): Budesonide/formoterol
Intervention type(s): Drug
Other intervention name(s): Symbicort
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma Reoccurrence; Acute Asthma; Patient Discharge; Emergency Service, Hospital; Asthma Exacerbation; Asthma Relapse
Efficacy of Prophylactic Internal Iliac Artery Balloon Catheterization in the Management of Placenta Previa and Accreta
Condition: Placenta Previa; Placenta Accreta
MeSH terms: Placenta Accreta; Placenta Previa
Study type: Interventional

Summary: 
      Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and
      even maternal death. Interventional radiological techniques have been developed to limit
      massive hemorrhage during caesarean section. This study investigated the efficacy of
      prophylactic internal iliac artery balloon catheterization in management for placenta previa
      and accreta.
    

Detailed description: 
      Placenta previa and accreta both could potentially cause serious postpartum hemorrhage and
      even maternal death. Interventional radiological techniques have been developed to limit
      massive hemorrhage during caesarean section. This study investigated the efficacy of
      prophylactic internal iliac artery balloon catheterization in management for placenta previa
      and accreta. Between June 2015 and August 2016,patients were personally recruited and managed
      by the authors,and assigned to either balloon group or control group by their willingness to
      catheterization or not. Both groups benefitted similar management protocol with the exception
      of interventional radiology operation. Intraoperative blood loss, transfusion volume,
      radiation dose, exposure time, surgical duration, procedure complications and neonatal
      outcomes were analyzed.
    

Intervention name(s): prophylactic internal iliac artery balloon catheterization; Prophylactic internal iliac artery balloon; Radiology operation
Intervention type(s): Procedure; Device; Radiation
Intervention description(s): Between June 2015 and August 2016
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Yogurt Added With Bifidobacteria and Soluble Fiber on Bowel Function.
Condition: Inflammatory Bowel Diseases
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study was to evaluate the effect of the consumption of yogurt added with
      bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A product as
      herein described is expected to improve gastrointestinal function and maintain the intestinal
      microflora balance of healthy subjects and perhaps of patients with altered bowel functions.
    

Detailed description: 
      The use of probiotics and prebiotics has become popular in human nutrition and food product
      development. The most common probiotics are Lactobacillus and Bifidobacterium species.
      Bifidobacteria spp are dominant in the intestinal microflora and are considered to be
      beneficial to the host, for this reason research efforts have focused on increasing their
      proportion in the intestinal microflora through oral administration of mixtures containing
      bifidobacteria or oral supplementation with prebiotics. An important limitation for the
      effectiveness of oral probiotics is that they might be destroyed during digestion in the
      gastrointestinal tract therefore and adequate vehicle could improve its potential benefits.
      Yogurt is a suitable vehicle for the administration of bifidobacteria, due to its
      physicochemical properties, such as pH and nutrients content, as well as the organoleptic
      properties that contribute to its increasing consumption. Thus simultaneous administration of
      probiotics and prebiotics in a suitable vehicle could act synergistically and may have
      potential for improving gut health. Few clinical trials have been performed using prebiotics
      and probiotics. The aim of this study was to evaluate the effect of the consumption of yogurt
      added with bifidobacteria and soluble fiber on gastrointestinal function of healthy adults. A
      product as herein described is expected to improve gastrointestinal function and maintain the
      intestinal microflora balance of healthy subjects and perhaps of patients with altered bowel
      functions.
    

Intervention name(s): yogurt added with bifidobacteria and soluble fiber (YBF)
Intervention type(s): Other
Intervention description(s): Yogurt in YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL
Other intervention name(s): yogurt LALA Vive; Yogurt LALA regular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: bowel function; functional foods
Sensory Reconstruction of Finger Pulp Defect Using a Dorsal Digital Island Flap
Condition: Trauma
Study type: Interventional

Summary: 
      Sensory reconstruction of the finger pulp is a challenging problem. This article reports
      repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches
      of the proper digital nerves (PDNs) were used for maximal sensory restoration.
    

Detailed description: 
      From February 2008 to May 2009, the flap harvested from the dorsum of the middle phalanx of
      the same finger was used in 12 fingers in 12 patients. The flaps ranged in size from 2.0 ×
      2.0 cm to 2.8 × 2.2 cm. The mean pedicle length was 1.2 cm. Neurorrhaphy between the dorsal
      branches of the PDN and PDN was performed in both sides in all cases. Sensibility of the
      reconstructed finger pulp was evaluated by static 2-point discrimination (2PD) and
      Semmes-Weinstein monofilament test. The range of motion of the donor fingers was measured.
      The data were compared to those of the opposite sides.
    

Intervention name(s): Sensate Dorsal Digital Island Flap
Intervention type(s): Procedure
Intervention description(s): This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.
Other intervention name(s): Surgical Flap; Island Flap
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Finger pulp reconstruction; dorsal branch; proper digital nerve; palmar arterial arch; dorsal digital island flap
Autobiographical Memory Organization in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The aim of the study is to investigate the temporal organization of autobiographical memory
      in patients with schizophrenia. Patients and control participants will be invited separately
      to participate in a 1hour walk in the city of Strasbourg and at the same time, to carry an
      automatic camera around their neck, which is called SenseCam®. Pictures obtained with
      SenseCam® will be later presented to the participants during the session of test. They will
      be asked to determine the chronological order of 12 pictures corresponding to 12 particular
      events of the tour. Then they will be asked to watch the complete sequence of photos from the
      tour and to determine the beginning and ending of the events that have occurred during the
      tour. According to the investigators hypotheses, patients should have difficulty to find out
      the correct chronological order of the photos and to determine the appropriate beginnings and
      endings of the events
    


Intervention name(s): questionary
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cognition; Autobiographical; memoryCognitive; remediation
Continuous Glucose Monitoring in New Mothers With Type 1 Diabetes
Condition: Hypoglycemia; Breastfeeding
MeSH terms: Hypoglycemia
Study type: Observational

Summary: 
      With appropriate day-time carbohydrate intake and insulin dose, the 24 hour glucose levels
      and prevalence of night-time hypoglycaemia are comparable in breastfeeding new mothers and
      formula feeding new mothers with type 1 diabetes at the second after delivery diabetes
      control compared with the first after delivery diabetes control at Steno Diabetes Center.
    


Intervention name(s): Continuous glucose monitoring (CGM)
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        New mothers with type 1 diabetes
A Randomized, Single-Dose, Comparative, Positive and Placebo Controlled, Four-Way, Four Period, Cross-Over Study to Evaluate the Effect of DIC075V on QTc Intervals in Healthy Subjects
Condition: Ventricular Repolarization
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is conducted to evaluate the effectiveness of DIC075V on ventricular
      repolarization in healthy subjects compared to placebo after a single dose of DIC075V
      administered intravenously (IV) and to evaluate ECG assay sensitivity by evaluating the
      baseline-adjusted effect of a single oral (PO) moxifloxacin 400 mg dose on ventricular
      repolarization in healthy subjects compared to placebo. Other secondary objectives are as
      follows:

        -  To evaluate the effect of DIC075V on ventricular repolarization in healthy subjects
           compared to placebo at the Tmax of diclofenac and hydroxypropyl-β-cyclodextrin (HPβCD).

        -  To determine if there is a pharmacokinetic/pharmacodynamic (PK/PD) relationship between
           the duration of the QTc intervals and diclofenac and HPβCD plasma concentrations.

        -  Obtain additional pharmacokinetic (PK) information on diclofenac and HPβCD in healthy
           subjects.

        -  Provide additional safety information.
    

Detailed description: 
      This is a randomized, single-dose, comparative, positive and placebo controlled, 4 period,
      4-way crossover study evaluating the effect of DIC075V on QTc intervals in healthy subjects.
      Two doses of DIC075V are tested and include moxifloxicin as a positive control and normal
      saline as the placebo arm. On 4 separate occasions separated by at least 72 hours, subjects
      are given single IV or oral (moxifloxicin) treatments. ECGs are acquired from a continuous
      Holter monitor and selected timepoints will be evaluated. These ECGs will be 15 seconds in
      duration and extracted in triplicate. Monitoring will continue for 24 hours with each
      treatment. The primary ECG endpoint is the baseline-adjusted QTc using the Fridericia
      correction (QTcF). Secondary endpoints include the baseline-adjusted QTc using the Bazett
      correction formula (QTcB). In addition, a population-specific regression model will be
      constructed with QT plotted against RR (the time elapsed between 2 consecutive R-waves).
      Finally, QT parameters are explored graphically in relation to PK variables Cmax, Tmax and
      AUC.
    

Intervention name(s): DIC075V
Intervention type(s): Drug
Intervention description(s): Four single dose treatments:
Placebo (normal saline)
Moxifloxacin (positive control)
DIC075V 37.5 mg
DIC075V 75 mg
All subjects receive each of the 4 treatments.
Other intervention name(s): Voltaren; Voltarol; Cataflam; Zipsor
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Safety and Tolerability of Repeated Subcutaneous Injections of CAD 106 in Mild Alzheimer's Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and tolerability of repeated subcutaneous injections of
      CAD106 in patients with mid Alzheimer's disease
    


Intervention name(s): Placebo; CAD106
Intervention type(s): Biological; Biological
Intervention description(s): Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Active immunization; Alzheimer's disease; Antibody; Vaccine; Central Nervous System Diseases; Neurodegenerative diseases
Four-week Open-trial Extension TNS for ADHD
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The purpose of this study will be to offer children previously randomized to sham treatment
      in a 5-week double-blind sham controlled study of Trigeminal Nerve Stimulation for ADHD
      (NCT02155608) an opportunity to receive 4-weeks active TNS treatment.
    

Detailed description: 
      This study will enroll participants with ADHD who previously participated in a 5-week
      sham-controlled investigation of Trigeminal Nerve Stimulation as a treatment for ADHD, and
      who were randomized to the sham condition.

      In the double-blind trial (NCT02155608), children ages 8-12 years undergo study screening and
      if eligible begin 4 weeks nightly treatment with active or sham TNS administered nightly
      during sleep. At the conclusion of the 4-week trial, all interventions (both active and sham
      TNS) are discontinued with blinding remaining in place for an additional week to assess
      possible residual treatment effects. Participants' randomized condition is unblinded at Week
      5.

      All participants randomized to sham in the double-blind trial are invited to participate in a
      4-week open-trial of TNS to allow all participants the opportunity to benefit from the active
      intervention.

      During this 4-week open-extension trial, interested participants will receive nightly active
      TNS during sleep. The final study visit (Visit 5) of the double-blind study will serve as
      baseline for this open-extension. Participants will return for clinic assessments at Weeks 2
      and 4. Participants who achieve clinically significant improvement from active TNS over the
      4-week open trial will be invited to receive a year of nightly active-TNS therapy as part of
      a 12-month extension study.
    

Intervention name(s): Active TNS
Intervention type(s): Device
Intervention description(s): Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study.
Other intervention name(s): Trigeminal Nerve Stimulation; Monarch eTNS SystemTM (NeuroSigma, Inc., Los Angeles CA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; neuromodulation; trigeminal nerve stimulation
Pathogenesis of Functional Hypothalamic Amenorrhea
Condition: Disorder of Endocrine Ovary; Hypersecretion; Cortisol; Metabolic Disturbance; Stress, Psychological
MeSH terms: Amenorrhea; Stress, Psychological
Study type: Interventional

Summary: 
      This is a randomized pilot study of the use of cognitive behavior therapy versus observation
      to treat functional hypothalamic amenorrhea, often termed stress-induced anovulation.
    

Detailed description: 
      The study enrollment was completed in 2003. The study results are being analyzed.
    

Intervention name(s): Cognitive behavior therapy
Intervention type(s): Behavioral
Intervention description(s): 16 sessions of 45 minutes each to review stress management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: functional hypothalamic amenorrhea; stress induced anovulation
Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells for the Treatment of Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor
      Cells Therapy
    

Detailed description: 
      A Multicenter, Randomized, Double-blind, Controlled Phase II Trial of Allogenic Adipose
      Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) Therapy for Knee Osteoarthritis.

      This is a multicenter, randomized, double-blinded, phase II clinical trial. Subjects who are
      with a clinical diagnosis of knee osteoarthritis cartilage defects and will be randomly
      distributed 1:1:1 to different group after signing the ICF and screening tests. Each group
      was treated for two cycles. The patients were followed up to 48 weeks after the first
      treatment.
    

Intervention name(s): Mesenchymal progenitor cells; No mesenchymal progenitor cells
Intervention type(s): Biological; Biological
Intervention description(s): Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra- articular use; No mesenchymal progenitor cells for intra- articular use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Exercise Training and Hepatic Metabolism in Overweight/Obese Adolescent
Condition: Obesity; Metabolic Syndrome X; Lipid Metabolism Disorders; Body Composition, Beneficial; Mental Health Wellness 1
MeSH terms: Overweight; Metabolic Syndrome; Metabolic Diseases; Lipid Metabolism Disorders
Study type: Interventional

Summary: 
      The HEPAFIT Study aims to examine whether a 6-months physical education program has benefits
      on hepatic metabolism and cardiovascular health as well as on selected physical fitness and
      mental health outcomes among adolescent overweight/obese from Bogota, Colombia.
    


Intervention name(s): Low physical activity program; High physical activity program; Low and High physical activity program; Conventional physical activity program
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.; Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.; Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.; One Physical Education sessions / week
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention