bioihbjkbjnl/mcl2 huggingface dataset:
Feeding Trial in Pediatric Patients
Condition: Developmental Disabilities
MeSH terms: Developmental Disabilities
Study type: Observational

Summary: 
      This is a single center, prospective, non-randomized, uncontrolled, observational study of
      the use of an enteral nutrition product in pediatric patients with developmental
      disabilities.
    

Detailed description: 
      This prospective observational study seeks to assess ability to achieve enteral feeding goals
      with a new tube feeding product in pediatric patients with developmental disabilities.
    

Intervention name(s): enteral formula
Intervention type(s): Other
Intervention description(s): Complete feeding of study enteral formula, route and regimen prescribed by the physician
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients with developmental disabilities
      
Keywords: Developmental disabilities; Enteral Nutrition; Tube feeding; Nutrition support
Evaluation of the Hypnotic Properties of Zolpidem-MR 12.5 mg and Zolpidem 10 mg Marketed Product Compared to Placebo in Patients With Primary Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective is to evaluate the hypnotic efficacy of zolpidem-MR (modified release)
      12.5 mg and zolpidem 10 mg marketed product in comparison with placebo in patients with
      primary insomnia and sleep maintenance difficulties, using polysomnography (PSG) recordings
      and patient sleep questionnaires.

      The secondary objective is to evaluate the clinical safety and tolerability of zolpidem-MR
      12.5 mg and zolpidem 10 mg marketed product in comparison with placebo.
    


Intervention name(s): zolpidem-MR (modified release); zolpidem (SL800750); placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insomnia
Caffeine Supplementation Improves the Cognitive Abilities and Shooting Performance of Trained E-sports Players
Condition: Caffeine; Placebo
Study type: Interventional

Summary: 
      Purpose: investigators explored the effect of 3 mg/kg of caffeine supplementation on the
      cognitive ability and shooting performance of trained e-sports players. Methods:
      investigators recruited nine e-sports players who had received professional training in
      e-sports and had won at least eighth place in national-level e-sports shooting competitions.
      After performing three to five familiarization tests, investigators employed a randomized
      crossover design to divide participants into a caffeine trial (CAF) and a placebo trial (PL).
      The CAF group took capsules with 3 mg/kg of caffeine, whereas the PL group took a placebo
      capsule. After a 1-h rest, the Stroop task, visual search ability test, and the shooting
      ability test were conducted.
    


Intervention name(s): caffeine
Intervention type(s): Behavioral
Intervention description(s): we employed a randomized crossover design to divide participants into a caffeine trial (CAF) and a placebo trial (PL). The CAF group took capsules with 3 mg/kg of caffeine, whereas the PL group took a placebo capsule. After a 1-h rest, the Stroop task, visual search ability test, and the shooting ability test were conducted.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: caffeine; reaction time
Effect of Background Noise on Sleep Quality
Condition: Sleep Onset Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Insufficient and low-quality sleep is a major public health problem that has been linked to
      motor vehicle crashes, industrial disasters, and medical and other occupational errors.
      Persons experiencing sleep insufficiency are also more likely to suffer from chronic diseases
      such as hypertension, diabetes, depression, and obesity, as well as from cancer, increased
      mortality, and reduced quality of life and productivity.

      The number of people using sleep-inducing drugs to increase or improve sleep is steadily
      increasing in the last few decades; however, the side effects of these therapies often
      outweigh the benefits.

      A few small trials and anecdotal findings suggest that continuous background (pink or white)
      noise overnight can improve sleep quality, increase acoustic arousal threshold, and reduce
      sleep onset latency.

      In an attempt to find new, alternative solutions to increase sleep quality in people
      suffering from insomnia, the investigators would like to test the effect of surrounding
      filtered white noise on sleep onset latency and subjective sleep quality in healthy subjects.
    


Intervention name(s): NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleep onset latency; sleep quality; insomnia
Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The endothelium is the lining of the blood vessels that helps prevent damage to the vessels.
      The endothelium does not function as well as it should in adolescents with type 1 diabetes.
      This causes future diabetes complications. Adolescents with diabetes also have abnormalities
      of the cells that repair the endothelium. These abnormalities may be due to damage caused by
      intermittent hyperglycemia. This studied is designed to study whether low dose, combined
      Vitamin C and E supplementation improves endothelial function and repair in adolescents with
      type 1 diabetes.
    


Intervention name(s): Vitamin C; Vitamin E
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): <30 kg 250 mg 30-60 kg 500 mg >60 kg 750 mg; <30 kg 100 IU, 30-60 kg 200 IU, >60 kg 300 IU
Intervention MeSH terms: Vitamins; Vitamin E
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; endothelial function; adolescents; vitamin C; vitamin E
Implementation of a Tool on Alimentary Empowerment in New-born Baby
Condition: Neonatal Feeding Disorder
MeSH terms: Feeding and Eating Disorders
Study type: Observational

Summary: 
      The alimentation of the premature newborn children is one of main thing concerning of nurses
      and pediatricians in neonatology. The absence of common tool of evaluation of the children
      cause a great discrepancy in prescriptions and the practices of the nursing.The aim of this
      study is to estimate the improvement of the food empowerment of the premature newborn
      children after the introduction of a help tool at the food progress which allows to fit the
      prescription of food(supply) to the capacities of the newborn child.
    

Detailed description: 
      If the importance of feeding premature newborns is a central concern during their management,
      the absence of an evaluation tool leads to a great disparity in their implementation
      (particularly marked by at regular times by the care teams), which can eventually lead to
      oral disorders. The possibility of an assessment of the newborn's skills could allow a
      homogenization of therapeutic proposals and thus a potentially faster progression of dietary
      independence of the newborn. This method could also encourage parental involvement in feeding
      care. The objective of the study is to evaluate the impact of a tool to help food progression
      on food autonomy.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        every baby born before 37 weeks of pregnancy between january 2017 and end of march 2017
Sex Steroid Hormones and Risk of CHD in Women
Condition: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Postmenopause; Coronary Arteriosclerosis
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Coronary Artery Disease; Arteriosclerosis; Myocardial Ischemia
Study type: Observational

Summary: 
      To investigate the relationship between endogenous estrogen and androgen levels and risk of
      coronary heart disease among postmenopausal women in the Women's Health
      Initiative-Observational Study (WHI-OS).
    

Detailed description: 
      BACKGROUND:

      The role of endogenous gonadal hormones in the etiology of atherosclerotic disease needs
      clarification. Previous studies of women have been small, rarely prospective, and had other
      methodological problems. Results have been inconsistent. Observational and clinical trial
      data on exogenous hormones, also inconsistent, are probably irrelevant to endogenous hormonal
      effects.

      On the other hand, despite hormonal differences being evoked as the reason for women having
      less atherosclerotic disease than men, it is not apparent from existing data that
      between-person variability in endogenous hormones is likely to be a strong risk factor for
      atherosclerotic disease in women. Furthermore, the atherosclerotic process begins early in
      life, and postmenopausal hormone differences are only one aspect of possible hormonal effects
      on disease. Nevertheless, this study has the potential to provide important new information
      on the role of endogenous hormones on atherosclerotic disease in postmenopausal women.

      DESIGN NARRATIVE:

      The study used a nested-case control design to measure baseline sex steroid hormone levels
      (serum total and free estradiol, estrone sulfate, total and free testosterone,
      dehydroepiandrosterone sulfate) and sex hormone binding globulin to determine whether these
      predicted subsequent risk of coronary heart disease (CHD). A total of 350 case subjects and
      350 control subjects were selected from women who were free from cardiovascular disease and
      cancer at study entry and were not using hormone replacement therapy at baseline. Cases were
      those women who subsequently developed a documented myocardial infarction or underwent
      coronary artery revascularization (N=350), while control subjects were selected from study
      participants who remained free from CHD during follow-up. Controls were matched 1:1 for age,
      ethnicity, smoking and follow-up time. The study also examined correlations between sex
      steroid hormone levels and other previously funded analyses of biomarkers, including
      thrombotic and inflammatory markers, lipoproteins, fasting glucose and insulin. Detailed
      baseline data including anthropometrics and behavioral factors allowed control for
      confounding.

      The study completion date listed in this record was obtained from the "End Date" entered in
      the Protocol Registration and Results System (PRS) record.
Nitric Oxide and the Autonomic Nervous System
Condition: Hypertension; Pure Autonomic Failure
MeSH terms: Pure Autonomic Failure
Study type: Interventional

Summary: 
      The amount of blood flowing to the different parts of the body is regulated by the autonomic
      (automatic) nerves and by local factors produced by the blood vessels. Nitric oxide (NO) is
      one of the most important of these metabolic factors. If the production of NO is slowed or
      stopped the amount of blood to the different parts of the body is decreased. There is
      increasing knowledge that NO mechanisms are impaired in a number of medical conditions. NO
      function is reduced in patients with risk factors for atherosclerosis (hardening of the
      arteries) such as hypercholesterolemia (patients with high cholesterol), or diabetes
      mellitus, and is also impaired in smokers. This NO "deficiency" is believed to contribute to
      the greater cardiovascular risk that marks these patient populations. This study is designed
      to examine if endothelial nitric oxide is an important control mechanism of blood pressure
      under normal conditions, and if impairment of nitric oxide contributes to hypertension.
    


Intervention name(s): L-NMMA; Trimethaphan
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of 125, 250 and 500 mcg/Kg/min for 15 minutes each dose. The main outcome is the maximal increase in blood pressure produced at the end of the infusions or a maximal systolic blood pressure of 160 mm Hg. It could be achieved after the first dose or the third.; IV infusion for the duration of the study at 4-6 mg/min depending on autonomic blockade. This is only to produce transient pharmacological blockade of the autonomic nervous system in order to allow the full expression of the inhibition of nitric oxide synthase. There is no direct outcome associated with this intervention.
Intervention MeSH terms: Trimethaphan; Trimethaphan camsylate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Endothelial Nitric Oxide; L-NMMA; Trimethaphan; Autonomic Nervous System; Nitric Oxide Inhibition
Phase 2 Trial of Nab-paclitaxel Plus S-1 vs Gemcitabine Plus Cisplatin as 1-line Chemotherapy of Patients With Local Advanced and/or Metastatic Transitional Cell Carcinoma of Urothelial Tract
Condition: Carcinoma, Transitional Cell
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients
      with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if
      clinical benefits and survival remains limited.

      The purpose of this study is to test in a randomized trial enrolling patients for comparing
      the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order
      to determine the most promising agents as the first line treatment of advanced and/or
      metastatic transitional cell carcinoma of urothelial tract.
    

Detailed description: 
      Gemcitabine plus cisplatin have been the most studied and used anticancer agents in patients
      with local advanced and/or metastatic transitional cell carcinoma of urothelial tract even if
      clinical benefits and survival remains limited.

      The purpose of this study is to test in a randomized trial enrolling patients for comparing
      the efficacy and safety of nab-paclitaxel plus S-1 with Gemcitabine plus cisplatin, in order
      to determine the most promising agents as the first line treatment of advanced and/or
      metastatic transitional cell carcinoma of urothelial tract.
    

Intervention name(s): nanoparticle albumin-bound paclitaxel, S-1; Gemcitabine, cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): Nanoparticle albumin-bound paclitaxel is given at 120mg/m2 intravenously over 30 minutes on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.; Gemcitabine is given at 1000mg/m2 combination with cisplatin 75mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
Other intervention name(s): nab-paclitaxel abraxane ABI-007; GEMXAR
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence
      suggests has consequences for functional adaptation and which cause difficulties in social
      re-integration after hospitalization. The investigators propose a large scale, multicentric
      study (7 centres from the Hermanas Hospitalarias del Sagrado Corazón de Jesús network) aimed
      at answering outstanding questions concerning the effectiveness of cognitive estimulation
      therapy for schizophrenic cognitive impairment. Specifically, the study will examine a)
      issues related to the size of the effect compared to treatment as usual and compared to a
      control intervention; b) generalizability of improvement to cognitive function and social
      cognition in daily life; and c) the durability of therapeutic gains after the end of
      treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three
      treatment conditions: a computer- assisted cognitive estimulation program (n=64),
      non-structured time on computer (n=64) and treatment as usual (n=64). A battery of
      neurocognitive tests of memory and executive function, including 'ecologically valid'
      measures, will be administered by blind evaluators at baseline, after 6 months of cognitive
      estimulation, and after 6 months follow-up. Symptoms, social functioning and self-esteem will
      be also be assessed at baseline, after the treatment and at follow-up.
    


Intervention name(s): Computer-assisted cognitive training; Computerized active condition; Treatment as usual (TAU)
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.; Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.; TAU: Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities.
Other intervention name(s): Computer-assisted cognitive training (CRT); Computerized active condition (CC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Schizophrenia; Rehabilitation; Cognition
Clinical Trial to Evaluate the Effect of Food on the Pharmacokinetic Characteristics of HIP0901 Capsule
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of food on the pharmacokinetic
      characteristics of fenofibric acid for HIP0901 capsule.
    


Intervention name(s): HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions
Intervention type(s): Dietary Supplement
Intervention description(s): The study drug(HIP0901 capsule(Fenofibric acid, 135mg)) will be administrated under fed or fasting conditions
Intervention MeSH terms: Fenofibric acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fenofibric acid; HIP0901; food effect
A Text Messaging Program to Help Prevent Early Opioid Relapse
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The objective is to determine feasibility and acceptability of a text message (SMS)-based
      relapse prevention intervention as measured through: (1) study retention and SMS query
      completion rates and (2) participant ratings of PIER1 interest, perceived efficacy, and ease
      of use. Methods: A mixed methods study of adult (age >=18) ED patients who seek treatment for
      opioids and have evidence of dependence based on Rapid Opioid Dependence Screen (RODS) score
      of >3 and are being discharged to outpatient (community) resources. All participants receive
      standard of care in the ED, complete a baseline web survey, are asked to text with us for at
      least 7 days (up to a max of 28 days) and are asked to complete a follow-up phone call
      between day 8 and 14. Investigators expect preliminary findings to support a relapse
      prevention intervention delivered through SMS. Based on feedback from this mixed methods
      study, investigators plan to test a refined SMS program in a randomized trial.
    

Detailed description: 
      The vast majority of those with opioid dependence do not receive treatment. This may be due
      to the limited availability of existing treatment programs and to a range of societal and
      individual-level barriers, including the stigma associated with identifying oneself as a
      substance user and difficulty attending a treatment program on a regular basis.
      Technology-based interventions have potential to help address these barriers and to expand
      access to evidence-based psychosocial treatment. Automated, computer-based interventions have
      found high user acceptance and utilization and shown promise in treating substance use
      disorders. The current study will evaluate a text-message-based psychosocial program called
      PIER1 (Preventing and Interrupting Early Relapse 1) when delivered to treatment-seeking
      opioid-dependent emergency department (ED) patients. PIER1 is an interactive program based on
      the Relapse Prevention Model. It is also informed by cognitive behavioral therapy and
      motivational interviewing.
    

Intervention name(s): PIER
Intervention type(s): Behavioral
Intervention description(s): Daily text message queries with tailored support
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Women With Migraine With Aura Neuroimaging Study
Condition: Migraine With Aura
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Observational

Summary: 
      The purpose of this study is to investigate whether a particular form of migraine, migraine
      with aura, is associated with structural changes in the brain
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Selected from a population-based twin registry
      
Keywords: migraine with aura; migraine; case-control study; magnetic resonance imaging; brain diseases