bioihbjkbjnl/mcl2 huggingface dataset:
Title: "Development and Implementation of Innovative Auditory Training Methods and Verification of These Training Methods"
Condition: Cochlear Implant
Study type: Interventional

Summary: 
      The purpose of this study is to determine if aural rehabilitation adds measurable benefit and
      participant satisfaction to a cochlear implant recipient's overall treatment. Also, the study
      is designed to compare the efficacy of a commercially available aural rehabilitation program
      (LACE) and an electronic program which takes advantage of a traditional form of auditory
      training (NOOK) for cochlear implant users.
    

Detailed description: 
      The primary objective of this study is to determine if aural rehabilitation adds measurable
      benefit and participant satisfaction to a cochlear implant recipient's overall treatment.

      The secondary objective of this study is to compare the efficacy of a commercially available
      aural rehabilitation program (LACE) and an electronic program which takes advantage of a
      traditional form of auditory training (NOOK) for cochlear implant users.
    

Intervention name(s): LACE; NOOK
Intervention type(s): Behavioral; Behavioral
Intervention description(s): commercially available LACE program which is administered by computer as daily lessons. The participants will do this program for one month; will use an electronic reader (Barnes and Noble - NOOK device) to do speech tracking.will do this activity for approximately one hour per day for five days out of seven for a total of four weeks. The speech tracking activity will involve reading approximately two books within the one month time frame. The participants will listen to the book while reading an unabridged book in printed form.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
FGF21 and Its Role in Alcohol Dependence
Condition: Alcohol Abuse or Dependence
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Plasma fibroblast growthfactor-21 (FGF21) responses to acute alcohol exposure will be
      evaluated in three groups: A: 15 individuals diagnosed with alcohol dependence (ICD10 code
      F10.2) and no alcoholic liver diseases, B: 15 healthy individuals with one or two parents
      with alcohol dependence, and C: 15 healthy matched controls without history of or disposition
      to alcohol dependence. The experimental day consists of a load of 0.5 g ethanol per kg body
      weight ingested from time 0-10 minutes followed by a 7 h period in which blood will be
      sampled with frequent intervals, rating of preference for ethanol, salt, sour, bitterly and
      sweets, sensations of hunger, appetite, satiety, headache, and nausea will be evaluated using
      visuel analogue scale and resting energy expenditure will be evaluated using indirect
      calorimetry.
    


Intervention name(s): Ethanol
Intervention type(s): Other
Intervention description(s): Ethanol administration
Intervention MeSH terms: Ethanol
Intervention model: Single Group Assignment
Intervention model description: Three matched groups. Group A: participants diagnosed with alcohol dependence, group B: participants with a father diagnosed with alcohol dependence, and C: a healthy control group.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Alcohol; FGF21; Alcohol dependence
Oral Glucosestimulation After Gastric Bypass Surgery
Condition: Obesity
Study type: Interventional

Summary: 
      The objective of this study is to examine gastric emptying and satiety hormones after oral
      glucose stimulation in 2 different concentrations in morbidly obese patients after
      Roux-en-Y-gastric-Bypass.
    

Detailed description: 
      After gastric bypass many patients suffer from early and/or late dumping syndrome as a
      reaction to carbohydrate rich meals. Gastric emptying after bypass is accelerated and
      nutrition enters the intestine faster, which leads to osmotically driven fluid shifts from
      the blood to the lumen. Late dumping occurs 1-3 h after eating, and is caused by
      hyperinsulinemia and is therefore characterized by symptoms of hypoglycemia like weakness,
      sweating, and dizziness. Many people have both types. In most studies examining satiety
      hormones after oral glucose stimulation in non-operated patients, glucose loads of 50-75g are
      used. For a measurable GLP-1 rise a threshold of 2 kcal/min. at the intestine is needed.
      After gastric bypass gastric emptying is accelerated and less glucose is necessary to reach
      this threshold. The "threshold load" and "tolerable load without dumping symptoms" is not yet
      know.
    

Intervention name(s): 25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate); 10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: glucose, blood
Improving Patient Understanding of Preeclampsia
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional

Summary: 
      Participants counseled with the preeclampsia educational tool will have a better
      understanding of preeclampsia than those not counseled using the tool.
    


Intervention name(s): ACOG education pamphlet on preeclampsia; Preeclampsia education tool
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The ACOG pamphlet on preeclampsia will be offered to this group; The newly created preeclampsia educational tool will be offered to this group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Patient understanding and counseling
Sildenafil in Sever Intrauterine Growth Retardation
Condition: Intra-Uterine Growth Retardation
MeSH terms: Fetal Growth Retardation
Study type: Interventional

Summary: 
      Severe fetal growth restriction (FGR) complicates approximately 0.4% of pregnancies and
      severely increases the risk of perinatal morbidity and mortality.Sildenafil citrate may offer
      a potential therapeutic strategy to improve uteroplacental blood flow in IUGR pregnancies.
    

Detailed description: 
      The aim of our study is to evaluate the effect of sildenafil citrate therapy on severe early
      and late onset intrauterine growth retardation.A total of 46 patients with severe early onset
      intrauterine growth retardation will be enrolled in a prospective case control study .

      Patients will randomly be allocated to two groups with 23 patients in each group.Sildenafil
      citrate therapy may increase the likelihood of increased growth velocity [measured by
      abdominal circumference (AC) (ultrasound)] for fetuses of pregnancies complicated by severe
      early-onset IUGR .Sildenafil is a potent and selective inhibitor of cGMP-specific
      phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP which results
      in increased levels of cGMP, leading to smooth muscle relaxation. Placental disease,
      consequent on deficient uteroplacental blood flow, includes FGR, pre-eclampsia, and placental
      abruption and has been implicated in more than 50% of iatrogenic premature births .For this
      reason, the problem of severe FGR forms a substantial portion of the population that tertiary
      care centres care.
    

Intervention name(s): treatment; Placebo
Intervention type(s): Other; Other
Intervention description(s): We will offer Sildenafil citrate (20 mg per os three times daily until delivery) as innovative therapy to 23 women with severe IUGR ('Sildenafil-treated') in addition to fish oil and zinc supplementation.; Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 46 patients with severe early onset intrauterine growth retardation will be enrolled in a randomized placebo control controlled study .
Patients will randomly be allocated to two groups with 23 patients in each group
Masking: Double (Participant, Investigator)
Primary purpose: Other
A Study of Lurasidone HCl in Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluates the effectiveness and safety of Lurasidone in subjects with schizophrenia
      over a period of 6 weeks.
    


Intervention name(s): Lurasidone
Intervention type(s): Drug
Intervention description(s): Lurasidone 40-160 mg/day for 6 weeks
Intervention MeSH terms: Lurasidone Hydrochloride
Intervention model: Single Group Assignment
Intervention model description: Lurasidone 40-160 mg/day
Masking: None (Open Label)
Primary purpose: Treatment
Effects of CX516 on Functioning in Fragile X Syndrome and Autism
Condition: Fragile X Syndrome; Autism
MeSH terms: Fragile X Syndrome; Syndrome; Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate whether CX516 can improve attention, memory, language, or
      behavior in adults with Fragile X Syndrome and/or Autism.

      CX516 is an AMPAKINE® compound. AMPAKINE compounds enhance synaptic strength. There is
      evidence to suggest that the synapses in the brain of an individual with fragile X syndrome
      are immature and abnormal. It is possible CX516 may partially correct this synaptic
      transmission defect and lead to improvement in cognitive and behavioral functioning.

      There is also reason to believe that these changes caused by CX516 could be helpful in
      managing cognitive and behavioral symptoms in patients with autistic disorder.

      Involvement for each participant will last 28 days. Participants will be given study
      medication, a physical exam, and a variety of cognitive assessment tests to study potential
      drug effectiveness at improving disease symptoms.
    


Intervention name(s): CX516 (Ampalex®)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Fragile X Syndrome; Autism
Movement Patterns in Young Volleyball Athletes
Condition: Injuries; Training; Athlete; Youth
Study type: Interventional

Summary: 
      This project is a consequence of the research chair project studying the same phenomenon in
      adult volleyball players. The project will make use of and be part of the routine medical
      screening that is taken by the young players of the first degree of the Leuven Volleyball
      School, Belgium. All young players must undergo a routine medical investigation and movement
      screening. This is obliged by the law. The current project will use these data. Outcome
      parameters will be used to advice the trainer staff of the school to adjust their training
      interventions. This is normal routine too as the involved medical department has been
      advising the school for many years. Players will be followed up for 6 weeks. After those 6
      weeks, the movement screening will be repeated to evaluate the change in the different
      outcome parameters. This last screening is not part of a normal routine as players normally
      are investigated more in a subjective way. The medical team and school want to change that
      routine.

      Data will be used to further improve training modalities and sports performance and reduce
      injury risk in these young athletes.
    


Intervention name(s): Training intervention
Intervention type(s): Other
Intervention description(s): Based on the baseline screening, which is part of the normal prevention routine within the school, all athletes are given individual advice with regard to points of attention within training. For example: those athletes with reduced balance, will get more balance training.
Intervention is individual as said and will be guided and supervised by the physical trainer and medical staff of the school.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Best Regimen for Phenylephrine Administration During Cesarean Section
Condition: Cesarean Section; Cardiac Output; Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 4

Summary: 
      During Cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. Low
      blood pressure is the most common side effect of the spinal medication used to anesthetize
      the patient prior to the start of surgery. This low blood pressure can also trigger
      unpleasant side effects such as nausea, vomiting and low Apgar scores for the baby.

      Currently there are 2 methods of phenylephrine administration during Cesarean section. One
      method is by intermittent bolus and the other is by continuous infusion. It is ideal to have
      a regimen for phenylephrine administration that maintains blood pressure without compromising
      cardiac output.

      In this study, cardiac output and blood pressure will be measured by transthoracic
      bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring.

      The hypothesis of this study is that the continuous infusion of phenylephrine will be equally
      effective in maintaining blood pressure as compared to the intermittent injection, and will
      induce less hemodynamic changes.
    


Intervention name(s): Phenylephrine
Intervention type(s): Drug
Intervention description(s): phenylephrine 120 micrograms/mL, administered either by continuous infusion or by intermittent bolus dose
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transthoracic bioreactance; noninvasive monitoring; vasopressor; blood pressure
Social Support and Education in Asthma Follow-up (SSEA)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      We will evaluate the effect of an eighteen-month asthma coaching intervention for
      parents/caregivers of children with asthma to reduce asthma morbidity. The primary objective
      is to determine if asthma coaching will significantly reduce asthma morbidity as measured by
      a reduction in the number of ED visits and hospitalizations for the children during the 18
      months of active coaching and during the 18 months after the coaching stops.

      We will provide half of the subjects (parents/caregivers) with access to assistance from an
      asthma coach for 18 months (including 2 contacts with an asthma nurse during the first 6
      months). The other half of the subjects will not have an asthma coach, but their children
      will have their usual routine care with their primary care providers. The nurse and coach
      will help the subjects learn more about caring for their children's asthma and improving
      interactions with the primary care providers for their children.
    

Detailed description: 
      BACKGROUND:

      Our previous NHLBI-supported study (HL 57232) showed that a combination treatment of
      "Coaching" through follow-up phone calls 2 and 5 days following an index ED visit plus
      monetary incentive was highly effective in increasing the percentage of low-income urban
      children who received recommended primary care within 2 weeks of the ED visit for asthma, 44%
      in the intervention group vs 29% in usual care (p = 0.0004). However, the intervention was
      not associated with significant differences in morbidity (subsequent ED visits). We conclude
      that the intervention was effective in promoting the initial link to primary care, but was
      not effective in sustaining that link or management practices to minimize acuity of symptoms
      during exacerbation.

      DESIGN NARRATIVE:

      Primary outcome The proportion of children of subjects in each group who have at least one ED
      visit for acute asthma symptoms during the thirty-six month period following enrollment.

      Key secondary outcomes A. The proportion of children of subjects in each group who are
      hospitalized during the thirty-six month period following enrollment.

      B. The proportion of children of subjects in each group who have either acute asthma visits
      or asthma-planning visits with their primary care providers.

      C. The costs of asthma-related care during the thirty-six month period D. Variables which may
      mediate or moderate the intervention such as the attitudes toward asthma care of the subjects
      and the personal social support perceived by the subjects .
    

Intervention name(s): Coaching
Intervention type(s): Behavioral
Intervention description(s): Patients received monthly calls to assist in behavioral change relative to asthma care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Dose Escalation Study of APR003 in Patients With Advanced Colorectal Cancer (CRC) With Malignant Liver Lesions
Condition: Advanced Colorectal Carcinoma
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1 dose escalation study to evaluate APR003 in patients with advanced colorectal
      cancer (CRC) with malignant liver lesions
    

Detailed description: 
      APR003 is a small molecule TLR7 agonist that concentrates in the GI, and liver with limited
      systemic exposure. It is designed to increase the therapeutic window of a TLR7 agonist by
      minimizing the side-effects associated with generalized systemic immune activation and
      inflammation.
    

Intervention name(s): APR003
Intervention type(s): Drug
Intervention description(s): This portion of the study further explores the clinical activity, safety, pharmacokinetics and pharmacology of APR003 monotherapy at the RP2D and to assess the antitumor activity of APR003 in subjects with unresectable CRC with liver metastases.
Intervention model: Sequential Assignment
Intervention model description: Phase 1 Dose Escalation
Masking: None (Open Label)
Primary purpose: Treatment
An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy
Condition: Prostate Cancer; Physical Activity; Side-effects
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This main purpose of this study is to examine the effects of an exercise intervention to
      counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate
      cancer patients. Specifically, a supervised and home-based exercise program will be used to
      assess its impact on clinical and behavioral variables related to ADT in prostate cancer
      patients.
    

Detailed description: 
      This study will assess the feasibility of an exercise intervention to counteract adverse side
      effects related to ADT in prostate cancer (PCa) patients. Specifically, we will use an
      exercise intervention and assess its impact on bone mass density, Body Mass Index (BMI),
      hip/waist circumference levels, biomarkers (i.e., glucose, lipids), step count, grip
      strength, and health-related quality of life (HRQOL) using the Patient Reported Outcomes
      Measurement Information System (PROMIS®). In this 8-week two-arm randomized clinical trial,
      40 PCa patients receiving ADT will be randomly assigned to an exercise (n=20) or a stretching
      control group (n=20) with a follow-up at 8-weeks.
    

Intervention name(s): Supervised and Home Based Exercise; Stretching Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise for 8-weeks. The exercise intensity will be tailored between 60-80% of their VO2max, as determined during baseline testing and with a rating of perceived exertion (RPE) of 11-14 on the 20-point scale.; Participants randomized into the control group will be provided an informational booklet with stretching techniques and exercises and will be asked to stretch at least 20-minutes a day for the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: prostate cancer; physical activity; exercise; intervention; side effects; androgen deprivation therapy
Effects of Exercise on Fructose Metabolism
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      A high fructose diet increases fasting and post-prandial triglyceride (TG) concentrations in
      sedentary healthy human subjects.These effects may be secondary to fructose-induced hepatic
      de novo lipogenesis. Recent evidence indicate that exercise can prevent fructose induced
      dyslipidemia.This study will evaluate

        1. how exercise effects the metabolic fate of oral fructose 1a) when exercise is performed
           before fructose ingestion 1b) when exercise is performed after fructose ingestion
           Metabolic effects of exercise will be assessed in healthy male subjects by measuring
           fructose oxidation (13CO2 production), fructose conversion into glucose (13C glucose
           concentrations in blood) and hepatic fructose conversion into lipid (13C palmitate-very
           low density lipoprotein (VLDL) concentrations in blood) after ingestion of 13C-labelled
           fructose meals

        2. how fructose and protein modulate muscle glycogen and intramyocellular lipid repletion
           after exercise Healthy male subjects will be fed various fructose, glucose, lipid and
           whey protein meals after a glycogen/intramyocellular lipid depleting exercise. The
           effects of meals' composition will be assessed after 24 hours by measuring
           intramyocellular lipids and glycogen using proton-magnetic resonance spectroscopy (MRS).
    


Intervention name(s): exercise; fructose; glucose
Intervention type(s): Other; Dietary Supplement; Dietary Supplement
Intervention description(s): cycling at 100W during 60 min; isocaloric nutrition with fructose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise; isocaloric nutrition with glucose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: gluconeogenesis; de novo lipogenesis; intramyocellular lipids; muscle glycogen; fructose