bioihbjkbjnl/mcl2 huggingface dataset:
Problem Solving Skills Training For Parent Caregivers of Youth With Chronic Pain
Condition: Chronic Pain; Abdominal Pain; Headache
MeSH terms: Chronic Pain; Headache; Abdominal Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility and efficacy of problem-solving
      skills training (PSST) to reduce distress and increase coping abilities among parents of
      youth with chronic pain. We hypothesize that parents will complete the PSST intervention and
      will find it to be an acceptable and satisfactory treatment. We also hypothesize that parents
      who receive PSST will have less distress and better coping skills than parents who receive
      standard care, and that children of parents who receive PSST will have better physical and
      emotional functioning than children of parents who receive standard care.
    

Detailed description: 
      Chronic pain affects 25-40% of children and adolescents, and results in significantly lower
      quality of life for these youth. Parents play an important role in how their children cope
      with chronic pain, and can also experience their own distress related to their child's
      illness. Parental psychological distress is widely recognized to be associated with poorer
      child adjustment. However, no interventions have been developed specifically to treat
      psychological distress in parents of children with chronic pain. Problem-solving skills
      training (PSST) has been shown to result in significant reductions in parental distress among
      caregivers of children with other types of chronic illness such as cancer. The purpose of
      this study is to test the feasibility and preliminary efficacy of PSST for parents of youth
      with chronic pain.
    

Intervention name(s): Problem-Solving Skills Training
Intervention type(s): Behavioral
Intervention description(s): Parents will receive 8, 1-hour sessions of individual problem-solving therapy over 8 weeks. Caregivers will complete the first training session and at least 3 subsequent sessions in person. Remaining sessions will be completed via telephone. In session 1, parents will be introduced to the PSST program and a rationale and explanation for problem solving strategies will be provided. During sessions 2-8, parents will identify a problem that they wish to work on. The therapist will use the primary cognitive-behavioral strategies of modeling, behavioral rehearsal, performance feedback, and generalization of skills in the process of teaching problem solving skills to parents. Parents will complete homework assignments to practice using the problem-solving skills in real-life situations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Pain; Abdominal Pain; Headache; Adolescents; Children; Parents; Problem-Solving Skills Training
Enhanced Diagnostics for Early Detection of Atrial Fibrillation - Prospective Validation
Condition: Atrium; Fibrillation; Arrhythmia Atrial
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Prospective, blinded, multicenter international trial to test the Preventicus Heartbeats App
      in a prospective cohort.
    

Detailed description: 
      Introduction This algorithm was validated earlier in a clinical trial with retrospective
      Data. The results were published accordingly.The algorithm is implemented in the commercial
      App Preventicus Heartbeats. DETECT AF is designed as prospective follow up trial.

      Study design Prospective, blinded, multicenter international trial.

      Methods

      The subjects will be asked to position a smartphone on their index finger to allow their
      pulse curve to be recorded for five minutes. At the same time, an ecg will be recorded using
      an digital mobile ecg recorder as a reference.

      Data will be collected on person-related information, comorbidities and medication (estimated
      overall duration/patient <20 min). No follow-up is planned. Analogous to predecessor studies,
      the pulse wave curve data are coded with the patient's identification number (ID) and
      externally analyzed at Preventicus; based on the results, the subjects will be assigned to
      SR/AF groups. After evaluation of all files, the grouped results will be aggregated,
      unblinded and evaluated under monitoring.

      Primary target parameters are the app's sensitivity and specificity in correctly detecting
      atrial fibrillation compared to an automatically interpreted ECG.

      Secondary target parameters include the proportion of non-evaluable recordings in the overall
      study.
    

Intervention name(s): Five minutes puls wave recording
Intervention type(s): Device
Intervention description(s): iPhone will be positioned on the index finger for five minutes to record a pulse wave
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients at the University Hospital Basel
      
Keywords: Atrial fibrillation; Rhythm monitoring; Cardiovascular App; m-health
Parents As The Agent Of Change For Childhood Obesity (PAAC)
Condition: Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The objective of this study is to test and evaluate the effectiveness of a parent-only
      treatment for childhood obesity. This study provides state-of-the-art treatment for childhood
      obesity. Parents and children will participate in treatment groups for 6 months. These
      treatment groups include recommendations to decrease overall caloric intake (by increasing
      fruits and vegetables), increasing physical activity, decreasing sedentary behavior and
      changing the home food environment. We are currently implementing this treatment in the
      Healthy Choices Program which is part of the Childhood Obesity Clinic at the University of
      Minnesota. Len Epstein at the University of Buffalo has been publishing on this treatment
      protocol for 30 years.
    

Detailed description: 
      The objective of this study is to pilot test and evaluate the efficacy of a parent-only
      treatment for childhood obesity. The central working hypothesis is that the parent-only
      treatment will result in greater weight loss for the overweight child as compared to the
      parent + child treatment. The specific aims of this application focus on comparing a
      behavioral parent-only intervention to a parent + child intervention for childhood obesity.

      The primary aim of the proposed study is to compare the efficacy of the parent-only treatment
      to the parent + child treatment for childhood obesity.

      The secondary aim is to compare treatment groups on change in the child and parent diet and
      exercise behavior, change in the home food environment, and parent weight post-treatment and
      at 6-months post-treatment.

      This study is a randomized, clinical pilot trial evaluating two 6-month treatments for
      childhood obesity; parent + child and parent-only groups, with 6-months of post-treatment
      follow-up. The two treatments will differ in terms of the designated recipient of treatment,
      which will be delivered either to parents-only or to parents and children separately. Study
      outcomes will be assessed at baseline, immediately post-treatment, and 6-months
      post-treatment.
    

Intervention name(s): Behavioral treatment for childhood obesity; Behavioral treatment for childhood obesity
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Behavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child.; Behavioral treatment for childhood obesity includes nutrition and physical activity recommendations, and behavior therapy skills for parent and child.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Childhood Obesity; Exercise; Nutrition
Orotracheal Intubation in Adult Patients: A Comparison of Standard Airtraq , Nasotracheal Airtraq Combined With a Stylet Inserted Endotracheal Tube and Standard Airtraq Combined Fiberoptic Intubation
Condition: Difficult Intubation
Study type: Interventional

Summary: 
      Adult patients requiring endotracheal intubation divided into three groups; standard Airtraq,
      Nasotracheal Airtraq + styletted endotracheal tube and Airtraq + fiberoptic combination
      groups.
    

Detailed description: 
      We enroll lean adult patients requiring endotracheal intubation. Using a sealed envelope
      technique they divided into three groups; Standard Airtraq and Nasotracheal Airtraq +
      styletted endotracheal tube and Standard Airtraq + fiberoptic combination. Demographic
      characteristics and airway management variables such; age, gender, height, weight, ASA
      status, tooth morphology, tiro mental and sternomental distance were recorded. Insertion
      times, intubation times and total intubation times with these devices will be recorded.
      Hemodynamic parameters recorded such as; heart rate will be recorded baseline , after
      anesthesia, after insertion, just after and then every 2 minutes intervals after intubation.
      sore throat, hoarseness, dysphasia, bronchospasm were also recorded postoperatively.
    

Intervention name(s): Airtraq + fiberoptic; Airtraq; Nasotracheal Airtraq + styletted tube
Intervention type(s): Device; Device; Device
Intervention description(s): video laryngoscope with a monitor; video laryngoscope with a monitor; video laryngoscope with a monitor
Other intervention name(s): videolaryngoscope; videolaryngoscope; videolaryngoscope
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Diagnostic
Use Of Valproid Acid To Treat Tropical Spastic Paraparesis/HTLV-1-Associated Myelopathy (TSP/HAM)
Condition: Paraparesis Spastic Tropical
MeSH terms: Muscle Spasticity; Paraparesis; Paraparesis, Spastic
Study type: Interventional
Phase: Phase 3

Summary: 
      Is the valproic acid efficacy to treat TSP/HAM
    


Intervention name(s): Valproic acid; costicosteroids; valproid acid plus corticosteroids
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15 mg/kg/day; metypredsolone 1 g/day; valporid acid 15 mg/kg/day plus corticosteroids 1 g/patient
Intervention MeSH terms: Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TSP/HAM, HTLV-1, treatment
Extensively Hydrolyzed Formula: Hypoallergenicity
Condition: Food Hypersensitivity
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Interventional

Summary: 
      The primary objective of this clinical trial is to determine whether a new extensively
      hydrolyzed infant formula is hypoallergenic.
    


Intervention name(s): Extensively hydrolyzed, whey protein infant formula; Extensively hydrolyzed, casein protein infant formula
Intervention type(s): Other; Other
Intervention description(s): New hydrolyzed formula; Commercially available hydrolyzed infant formula
Other intervention name(s): Baby Formula; Baby Formula
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cow's Milk Allergy; CMA
Effects of Duloxetine vs. Escitalopram on Heart Rate Variability in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Low heart rate variability is a marker of increased risk of cardiac mortality, and is
      observed in depressed coronary artery disease patients. Some antidepressants may themselves,
      however, decrease heart rate variability. We will test the hypothesis that greater reduction
      in heart rate variability will be associated with duloxetine (which has noradrenergic
      activity) than escitalopram (a selective serotonin reuptake inhibitor). We will also test the
      hypothesis that changes in heart rate variability are related to the magnitude of
      norepinephrine transporter occupancy.
    

Detailed description: 
      Evaluation of heart rate variability (HRV) has been shown to be a valuable tool for measuring
      autonomic dysfunction associated with depression and with cardiac disease. Low HRV is a
      marker of increased risk of cardiac mortality, and is observed in depressed coronary artery
      disease patients and in anxious patients post-MI. Treatment with sympathomimetic
      antidepressants, such as MAO inhibitors and tricyclics, reduce HRV further, and have been
      associated with elevated heart rate, orthostatic hypotension, and with adverse cardiac
      events. Although there is increasing evidence that the selective serotonin reuptake inhibitor
      (SSRI) class of antidepressants have minimal effects on the cardiovascular system, the case
      is less clear with the SNRI antidepressants which block the reuptake of both serotonin and
      norepinephrine. It is possible that measures of the extent of norepinephrine transporter
      blockade or inhibition may relate to the HRV reduction seen with noradrenergic drugs. Given
      these considerations, we propose a study to compare the cardiovascular profile of the SSRI
      escitalopram (Lexapro), with the most recently available SNRI, duloxetine, in outpatients
      with depression. Using HRV methodology, we will test the hypothesis that greater reduction in
      HRV will be associated with duloxetine than escitalopram. In addition, we will measure the
      magnitude of serotonin and norepinephrine transporter occupancy produced by each drug. This
      will allow us to examine the relationship between changes in HRV to the magnitude of
      transporter inhibiting effects of each drug.
    

Intervention name(s): duloxetine vs. escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
PremCry Study : Study of Ontogeny of Crying in Preterm Infants.
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      Crying is a survival mechanism for babies and their almost exclusive means of expression
      until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger,
      discomfort or separation following the departure of a parent around. Crying is a complex but
      essential means of communication and information between a baby and his parents that raises
      the question of their meaning.

      Very few longitudinal studies have been produced on preterm's crying. As the term approaches,
      the characteristics of preterm babies' crying are similar to those of term infants. But these
      studies date back more than 30 years and are obsolete in terms of the quality and performance
      of sound recording equipment and signal processing.

      No study has looked at the genesis of the cry itself and the varieties of the cry of the
      preterm baby, depending on whether it was in a situation of hunger, pain, discomfort (bath).
    

Detailed description: 
      This longitudinal study recordings of crying babies from 26 amenorrhea week to 33 amenorrhea
      week, 24 hours per week, each week until the return home. In the same time, parents will be
      asked to know the situation of the baby (hunger, pain, bath).
    

Intervention name(s): cries longitudinally registered
Intervention type(s): Other
Intervention description(s): Their cries will be longitudinally registered from the age of birth to the return home using an automatic record device: Song Meter SM4.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infant born between 26 and 33 amenorrhea week will be included.
      
Keywords: Newborn; ontogeny of crying; preterm infants
Norwalk Vaccine Study
Condition: Acute Gastroenteritis; Norwalk Virus Infection
MeSH terms: Infections; Virus Diseases; Gastroenteritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to evaluate the efficacy of the Norwalk virus-like particle
      (VLP) vaccine as determined by the illness rate of viral acute gastroenteritis (AGE) during
      the inpatient stay.
    

Detailed description: 
      The drug being tested in this study is called intranasal Norwalk virus-like particle (VLP)
      vaccine. Norwalk VLP vaccine is being tested to prevent viral acute gastroenteritis (AGE).
      This study will look at the illness rate of AGE in people who are administered the Norwalk
      VLP vaccine.

      The study enrolled 98 patients and was conducted in 2 stages: the Vaccination Stage and the
      Challenge Stage. In the Vaccination Stage participants were randomly assigned (by chance,
      like flipping a coin) to one of the two treatment groups-which remained undisclosed to the
      patient and study doctor during the study (unless there is an urgent medical need):

        -  Norwalk VLP Vaccine (100 µg VLP) intranasally

        -  Placebo (dummy inactive powder) - this is a powder that looks like the study drug but
           has no active ingredient During the Challenge Stage participants were administered live
           Norwalk virus and were monitored for AGE.

      This multi-center trial was conducted in the United States. The overall time to participate
      in this study was up to 29 weeks Participants made multiple visits to the clinic and were
      contacted by telephone 6 months after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Norwalk VLP vaccine; mannitol and sucrose; Norwalk virus
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Norwalk VLP vaccine dry powder; Mannitol and sucrose as placebo-matching Norwalk VLP Vaccine dry powder; Norwalk virus solution
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention of acute gastroenteritis due to infection with and experimental Norwalk Virus
Topotecan in Treating Patients With Myelodysplastic Syndrome
Condition: Leukemia; Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die.

      PURPOSE: Randomized phase II trial to study the effectiveness of topotecan in treating
      patients who have myelodysplastic syndrome.
    

Detailed description: 
      OBJECTIVES: I. Estimate complete or partial remission, hematologic improvement, and cytogenic
      response rate when oral topotecan is given twice a day for 5 days versus once a day for 10
      days to patients with myelodysplastic syndromes. II. Evaluate the safety and toxicity of oral
      topotecan in these patients. III. Evaluate whether there are morphologic and/or cytogenetic
      subsets of the myelodysplastic syndromes that will respond optimally to this regimen. IV.
      Evaluate the change in the percentage of bone marrow blast cells in these patients during
      treatment. V. Evaluate the time to transformation to acute myeloid leukemia (AML) or death in
      this patient population.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to FAB
      subtype: 1. Refractory anemia with excess blasts 2. Refractory anemia with excess blasts in
      transformation 3. Chronic myelomonocytic leukemia 4. Refractory anemia, refractory anemia
      with ringed sideroblasts, and refractory cytopenia with multilineage dysplasia Patients are
      randomized to receive oral topotecan either twice daily for 5 days or once daily for 10 days.
      Courses are repeated every 21 days. Patients are evaluated for hematologic response after the
      initial 2 courses, and then every 4 courses. If a partial response or hematologic improvement
      is observed, treatment continues until disease progression to acute myeloid leukemia,
      relapse, death, or irreversible toxicity. Patients who achieve a complete response receive an
      additional 2 courses of therapy before discontinuation of protocol treatment. Patients are
      followed every 3 months for 2 years, then every year for an additional 3 years, and at time
      of progression.

      PROJECTED ACCRUAL: A total of 90 patients (45 per arm) will be accrued for this study within
      13 months.
    

Intervention name(s): topotecan hydrochloride
Intervention type(s): Drug
Intervention description(s): 1.2 mg/sq m twice a day for 5 days (Arm I) and once a day for 10 days (Arm II)
Intervention MeSH terms: Topotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory anemia; refractory anemia with ringed sideroblasts; refractory anemia with excess blasts; refractory anemia with excess blasts in transformation; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; secondary myelodysplastic syndromes; refractory cytopenia with multilineage dysplasia; childhood myelodysplastic syndromes
Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A
Condition: Blood Coagulation Disorders; Hemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of
      prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period
      (split into two six month treatment periods). The study will compare 2 different methods
      (assays) for measuring the amount of study drug, the chromogenic substrate assay per European
      Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ).
      During one six month period patients will receive the study drug where the dose has been
      measured using the" (CS/EP) and during the other six months period the dose will be measured
      based on the Chromogenic Substrate Adjusted assay CS/ADJ)
    


Intervention name(s): Recombinant Factor VIII (BAY81-8973); Recombinant Factor VIII (Kogenate FS, BAY14-2222); Recombinant Factor VIII (BAY81-8973); Recombinant Factor VIII (BAY81-8973)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Single dose of BAY81-8973 crossed over to single dose of Kogenate FS; Single dose of Kogenate FS crossed over to Single dose of BAY81-8973; Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.; Participants received a loading dose of approximately 50 IU/kg of BAY 81-8973 before the first surgical incision followed by further treatment with BAY 81-8973 according to surgical requirements for up to 3 weeks
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia A; Factor VIII; Prophylaxis