bioihbjkbjnl/mcl2 huggingface dataset:
MCRF Clinical Pilot Study
Condition: Emotional Adjustment
Study type: Interventional

Summary: 
      The purpose of this study is to see if music can help children practice how to manage their
      emotions.
    


Intervention name(s): Musical Contour Regulation Facilitation (MCRF)
Intervention type(s): Behavioral
Intervention description(s): MCRF involves 20-minute music therapy sessions comprised of seven interconnected components. Each session follows the same contour of neutral, low, and high arousal experiences facilitated through music.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are six classroom assignments. Classrooms will be randomized to either of the treatment arms.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: At-risk preschoolers; Head Start; Emotion regulation
Guided Imagery Training and Self-Referential Processing
Condition: Depression; Negative Thoughts
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy of a guided imagery paradigm for
      reducing negative ways of thinking about the self. There will be at least 60 participants
      enrolled at the University of Texas at Austin. Participants will be randomly selected to
      receive one of two types of trainings, each over the course of two weeks. Participants will
      undergo the training exercises at home. The training exercises will help them to think
      differently about themselves.

      Participants will be able to determine if they are eligible, and then participate, by filling
      out a screening questionnaire online.
    

Detailed description: 
      This study uses a randomized controlled trial to compare two types of guided imagery. One
      intervention is an active intervention; the other is intended to be inert. These
      interventions were developed based on extensive research indicating the efficacy of using
      imagery in depression, and a perceived lack of treatments targeting biased self-referential
      processing.

      This protocol aims to develop a novel intervention which can be used on its own or as an
      adjunct to existing treatments. Common treatments for Major Depressive Disorder (MDD) are
      diffuse; this paradigm instead aims to specifically target negative self-schema, a part of
      the cognitive model of MDD. This study focuses on participants with elevated depressive
      symptoms.
    

Intervention name(s): Positive Self-Reference Training; Neutral Training Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in this intervention will review a brief psychoeducational video describing the training, and then be given cues every other day designed to practice skills. Participants will then practice visualizing and describing scenes based on these cues. This training will be focused on positive self-referent material.; Participants in this intervention will review a brief psychoeducational video describing the training, and then be given cues every other day designed to practice skills. Participants will then practice visualizing and describing scenes based on these cues. This training will be focused on neutral, non-self-referent material.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Guided Imagery
Study of Two Doses of Oral HDV-Insulin and Placebo With Background Metformin Treatment in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objective of this trial is to compare the reduction in mean glycated hemoglobin
      levels (HbA1c) between 2 doses of oral HDV-I and placebo in type 2 diabetic patients on
      background metformin therapy at the end of 18 weeks of treatment.

      The secondary objectives are:

        -  To evaluate the effects of oral HDV-I versus placebo on the 7-point glucose test,
           fasting plasma glucose (FPG), insulin, homeostasis model assessment of insulin
           resistance (HOMA-IR), homeostasis model assessment of β-cell function (HOMA-β),
           frequency of hypoglycemic events, body weight, and lipid levels; and

        -  To evaluate the safety and tolerability of oral HDV-I.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled study with a
      washout/stabilization period of up to 12 weeks in duration and an 18-week double-blind
      treatment period. There will be a total of 8 visits.
    

Intervention name(s): placebo; Oral Hepatic Directed Vesicles (HDV)-Insulin (U-15); Oral Hepatic Directed Vesicles (HDV)-Insulin (U-5)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): placebo capsule,0 units, quater in die (QID) for 18 weeks; Oral HDV-I Caps; 15 U; quater in die (QID) for 18 weeks.; Oral HDV-I; Caps; 5 U; quater in die (QID) for 18 weeks.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type 2
Impact of a Low-Carbohydrate Diet in Pediatric Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Dietary carbohydrate consumption is a key factor influencing postprandial glycemia for
      patients with type 1 diabetes mellitus (T1DM). Because post-prandial glucose excursions
      profoundly influence hemoglobin A1c (HbA1c), therapeutic approaches to mitigate post-prandial
      hyperglycemia are of great importance. The quantity and source of carbohydrates affect
      post-prandial glycemia more than any other dietary factor. These findings serve as the
      physiologic basis for a growing interest in carbohydrate-restricted diets in the management
      of T1DM despite American Diabetes Association (ADA) guidelines that discourage restricting
      total carbohydrate intake to less than 130 grams per day. Although case series and
      prospective studies suggest low-carbohydrate diets (LCD) significantly improve HbA1c for
      adults with T1DM, data in the pediatric T1DM population is limited. The investigators will
      conduct a randomized prospective pilot study evaluating glycemic control, lipidemia, and
      quality of life (QOL) in pediatric T1DM patients on a LCD.
    


Intervention name(s): Dietary Intervention
Intervention type(s): Other
Intervention description(s): The investigators will prescribe isocaloric diets equaling the estimated energy requirements of the Institute of Medicine with varying macronutrient content in each group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Low Carbohydrate Diet; Standard Carbohydrate Diet
A Study Comparing Irinotecan and Cisplatin (IP) With Etoposide and Cisplatin (EP) Following EP/TRT for LD-SCLC
Condition: Small-Cell-Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the role of 3 cycles of irinotecan and cisplatin for patients with limited-stage
      small-cell lung cancer who received one course of etoposide and cisplatin plus concurrent
      accelerated hyperfractionated thoracic irradiation.
    

Detailed description: 
      The Japan Clinical Oncology Group (JCOG) previously conducted a randomized phase III trial
      comparing irinotecan and cisplatin (IP) with EP in patients with extensive-stage SCLC. The
      response rate and overall median survival were significantly better for IP, i.e. 84.4% and
      12.8 months with IP, versus 67.5% and 9.4 months with EP, respectively. The 2-year survival
      rates were 19.5% for IP and 5.2% for EP (7). These encouraging results prompted us to explore
      the use of IP in LSCLC.
    

Intervention name(s): Etoposide and cisplatin after chemoradiotherapy; Irinotecan and cisplatin after chemoradiotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Etoposide and cisplatin after chemoradiotherapy; Irinotecan and cisplatin after chemoradiotherapy
Intervention MeSH terms: Cisplatin; Irinotecan; Etoposide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Small-cell lung cancer; Limited-Stage Small-Cell Lung Cancer; Combined modality therapy; chemotherapy; radiotherapy; Irinotecan; Cisplatin
Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation
Condition: INFERTILITY; Fertility Preservation; Ovulation Induction; Vitrification; Oocyte Donation
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in
      oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes
      donors . This study will be performed in egg recipients and donors but this type of treatment
      is meant to be implemented in fertility preservation patients
    


Intervention name(s): gonadotropins plus GnRH antagonists; ganirelix
Intervention type(s): Drug; Drug
Other intervention name(s): Ovarian stimulation; the investigators will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix
Intervention MeSH terms: Ganirelix
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovarian stimulation; Luteal phase; Egg donors; Fertility preservation
Pathways Linking Reduced Sleep Duration and Quality to Obesity Risk
Condition: Obesity; Diabetes
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study is designed to study the pathways through which short sleep duration or poor sleep
      quality can lead to an increased risk of developing diabetes and obesity.
    


Intervention name(s): Baseline; Sleep restriction; Reduced Sleep Quality
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects are allowed time in bed for sleep as their usual time at home.; Subjects sleep is reduced to 4.5 hours in bed for 4 nights.; Subjects sleep quality is reduced for 4 nights.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: obesity; diabetes, risk; obesity, diabetes risk related to sleep
Magnesium Sulphate for Attenuation of Hemodynamic Pressor Response After Myfield's Clamp Application
Condition: Supratentorial Brain Tumor
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      Use of Mayfield skull clamp during craniotomies; results in a sharp and intense noxious
      stimulus which results in a severe hemodynamic pressor response. Many strategies have been
      reported to blunt this undesirable pressor effect. This prospective, double blind, and
      randomized study is the first to evaluate the effect of MgSo4 on attenuation of hemodynamic
      pressor activity after head clamp application during craniotomies.
    

Detailed description: 
      Background: Use of Mayfield skull clamp during craniotomies; results in a sharp and intense
      noxious stimulus which results in a severe hemodynamic pressor response. Many strategies have
      been reported to blunt this undesirable pressor effect. This prospective, double blind, and
      randomized study is the first to evaluate the effect of MgSo4 on attenuation of hemodynamic
      pressor activity after head clamp application during craniotomies.

      Methods: This randomized, double blind, and prospective study was done in Neurosurgical
      department at ElSahel Teaching Hospital in Cairo from February 2016 till august 2017. All
      adult patients aged from 18 to 60 years of both genders, ASA physical status I and II
      scheduled for craniotomies were assessed to enter this study. Seventy one patients were
      assessed preoperatively, sixty of them were enrolled and assigned in two groups (n=30 each).
      Group M received 50 mg/kg MgSo4 in 100 ml 0.9 sodium Chloride 15 minutes prior to anesthesia
      induction over 15 minutes. Group S received 100ml 0.9% Sodium Chloride over the same period
      with the same rate.Mean HR was recorded as a primary outcome , meanwhile; MAP and the need
      for a bolus dose of fentanyl was considered a secondary outcome.
    

Intervention name(s): MgSo4; 0.9% NaCl
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg/kg MgSo4 in 100 ml 0.9 sodium Chloride 15 minutes prior to anesthesia induction over 15 minutes; 100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes
Other intervention name(s): magnesium sulphate; normal saline
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MgSo4, Mayfield clamp, pressor effect
Safety and Tolerability Study of Flexible Dosing of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Condition: Agitation Associated With; Alzheimer's Disease; Alzheimer's Type; Mental Disorder; Nervous System Diseases
MeSH terms: Alzheimer Disease; Dementia; Psychomotor Agitation; Nervous System Diseases; Mental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of flexible dosing of brexpiprazole with placebo in subjects with
      agitation associated with dementia of the Alzheimer's type
    

Detailed description: 
      Behavioral symptoms, such as agitation, are core features in subjects with Alzheimer's
      disease and related dementias and develop in the majority of dementia subjects. The presence
      of agitation in subjects with Alzheimer's disease places a significant burden not only on
      subjects and their caregivers but also on the healthcare system.

      This is a trial designed to assess the safety and efficacy of flexible dosing of
      brexpiprazole in the treatment of subjects with agitation associated with dementia of the
      Alzheimer's type. The trial consists of a 12-week double-blind treatment period with a 30-day
      follow-up. The trial population will include male and female subjects between 55 and 90 years
      of age (inclusive) with a diagnosis of probable Alzheimer's disease, who are residing either
      in an institutionalized setting or in a non-institutionalized setting where the subject is
      not living alone.
    

Intervention name(s): Brexpiprazole, OPC-34712
Intervention type(s): Drug
Intervention description(s): Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: OPC-34712; brexpiprazole; Dementia; Alzheimer's Disease; Cognitive Disorders; Agitation
Role of Mosapride in Patients With Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 4

Summary: 
      Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In
      Taiwan, this disease is increasing gradually because the investigators' eating style is
      closing to Western world.

      Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent
      is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of
      prokinetic agent in the management of GERD.
    

Detailed description: 
      This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one
      month and two months of the study.

      This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching,
      dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of
      gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients
      receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and
      lansoprazole 30 mg once plus placebo tid daily in the second month. Another fifty patients
      receive lansoprazole 30 mg once plus placebo tid daily in the first month; and lansoprazole
      30 mg once plus mosapride 5 mg tid daily in the second month.
    

Intervention name(s): mosapride for the first month and placebo for the 2nd month; placebo for the first and mosapride for the second month
Intervention type(s): Drug; Drug
Intervention description(s): lansoprazole 30 mg once per day for 2 months mosapride 5 mg thrice per day, for the first month placebo thrice per day, for the second month; lansoprazole 30 mg once per day for 2 months placebo thrice per day, for the first month mosapride 5 mg thrice per day, for the second month
Intervention MeSH terms: Mosapride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal reflux disease; Mosapride; Lansoprazole
Anxiety Level of Child and Parents During Preoperative Anesthesia Evaluation
Condition: Anxiety State; Parent; Child
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      1. Appreciation of preoperative anxiety in children is important for the anesthesiologist.

        2. Several factors defined to effect the anxiety levels preoperatively in children such as
           , age, previous medical encounters , education level and parental anxiety. 3. This
           information was tested for Turkish children during the preoperative anesthetic
           evaluation.
    

Detailed description: 
      1. Before the planned surgery all children accompanying parents filled a questionnaire
           about the demographics, marital status, economical conditions, education level and other
           diseases and operations in the family.

        2. Both the parent and child filled State and Trait Anxiety tests specially prepared for
           adults Spielberger Anxiety tests and children defined and validation tests had already
           been proven.

      Statistical analysis performed for evaluation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children planned to undergo surgical procedures or diagnostic procedures under general
        anesthesia
      
Keywords: anxiety; preoperative
Hyperglucagonaemia in Patients With Type 2 Diabetes - Role of Glucagon Clearance
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The study aims to evaluate the elimination and degradation of glucagon in patients with type
      2 diabetes compared to matched healthy subjects.
    

Detailed description: 
      In the present project the investigators wish to identify whether the elimination and
      degradation of glucagon differ between healthy control subjects and patients with type 2
      diabetes. Furthermore, the investigators wish to examine whether obesity is an independent
      factor for altered glucagon metabolism. Thus, by examining glucagon elimination in obese
      subjects with and without type 2 diabetes and in lean subjects with and without type 2
      diabetes the investigators will be able to describe the metabolic clearance rate (MCR) of
      glucagon in a broad spectrum of individuals with different levels of insulin resistance and
      beta cell dysfunction.
    

Intervention name(s): Glucagon
Intervention type(s): Biological
Intervention description(s): One hour glucagon-clamp followed by one hour of blood sampling
Intervention MeSH terms: Glucagon
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Diabetes; Glucagon; Metabolic clearance rate of glucagon
Pectin, Aging and Intestinal Barrier Function
Condition: Healthy Young Adults; Healthy Elderly
Study type: Interventional
Phase: Phase 4

Summary: 
      The population is aging worldwide, which requires more attention to health needs and leads to
      a dramatic increase in health care costs. Prevention or delay of onset of disorders
      associated with aging is needed. Dietary intake of pectin, a dietary fiber, may have
      beneficial effects on gut health parameters, i.e. intestinal barrier function, immune
      function and microbial composition. As intestinal barrier function may be compromised in the
      elderly we will investigate whether the effects of pectin on selected parameters of gut
      health differ between young vs. older individuals. The primary objective of this study is to
      investigate the effects of aging on pectin-induced changes in intestinal permeability.
      Furthermore, this study has seven secondary objectives. This study conforms to a randomized,
      double-blind and placebo-controlled design including two parallel arms.The study population
      consists of Healthy human volunteers (male and female), 18-40 and 65-75 years old, BMI 20-30
      kg/m2. One group will receive 7.5 grams of pectin supplements twice daily for four weeks. A
      second group will receive 7.5 grams of placebo supplements twice daily for four weeks. Before
      and after the supplementation period, several measurements will take place. The main study
      parameter is the change in urinary sugar excretion ratio before and after the intervention
      period.
    


Intervention name(s): Pectin; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This group will receive 7.5 grams of pectin supplements twice daily for four weeks.; This group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention