bioihbjkbjnl/mcl2 huggingface dataset:
Bone Mass Accrual in Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder; Bone Diseases, Developmental
MeSH terms: Bone Diseases; Bone Diseases, Developmental; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Observational

Summary: 
      This is a observational study to investigate the degree to which bone mineral density is
      impaired in boys with autism compared with typically developing controls.
    

Detailed description: 
      Studies have shown that bone cortical thickness is decreased in children with autism and
      other developmental disabilities. However it is not known whether bone mineral density (BMD)
      of these children is lower; neither is it known whether there is any correlation between BMD
      and the child's diet. The overall goal of this study is to improve the long term health of
      children and adolescents with autism spectrum disorder; more specifically the investigators
      aim to develop a pilot study to investigate the degree to which BMD is impaired in boys with
      autism and to explore specific additional risk factors. In addition, the aim is to
      investigate the degree to which BMD is impaired in boys with Autism Spectrum Disorder (ASD)
      and to explore specific contributing risk factors including nutritional analysis.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adolescent boys, ages 8-17 years, recruited from a clinic population (ASD) or community
        advertisements (ASD and control) matched for age.
      
Keywords: bone mineral density; Autism Spectrum Disorder; Autism
Vitamin D Supplementation and Pregnancy Outcomes
Condition: Maternal Vitamin D Status
Study type: Interventional

Summary: 
      Groups (group 1 receives 1000 IU vitamin D and group 2 receives 2000 IU vitamin D) through a
      random allocation. It is necessary to mention that all cases in each group could be able to
      receive the current supplementation during pregnancy (Folic acid, iron and multivitamin and
      calcium). This study aimed to evaluate the efficacy of two doses of vitamin D supplementation
      (1000 and 2000 IU/d) during pregnancy on maternal and newborn vitamin D status and metabolic
      profile including lipid profile (serum concentration of total cholesterol (TC), low-density
      lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C),
      triglyceride(TG)), glucose homeostasis (fasting glucose, insulin, insulin resistance
      (HOMA-IR)) and inflammatory and oxidative stress (OS) markers and pregnancy outcomes
      including gestational diabetes, preeclampsia, preterm delivery, abortion, cesarian section,
      and also anthropometric data and apgar score of infants compared with placebo.
    

Detailed description: 
      In this randomized controlled trial, 84 pregnant women aged at 18-40 years with gestational
      age of <12 weeks will be recruited and divided into 2 groups.

      Demographic, socioeconomic and lifestyle data as well as blood samples and urine samples will
      be collected at baseline and in the last month of pregnancy. Moreover the cord blood will be
      collected at birth.

      Fasting blood glucose, insulin resistance (HOMA-IR), insulin, lipid profile (serum
      concentration of total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C),
      high-density lipoprotein cholesterol (HDL-C), triglyceride(TG)), inflammatory (IL-1β, IL-6,
      TNF-α, hs-CRP) and oxidative stress markers (MDA, TAC), calcium:creatinine ratio are going to
      be evaluated at the beginning and in the end of the interventional period in pregnant women.
      Inflammatory (IL-1β, IL-6, Tumor Necrosis Factor (TNF-α), hs-CRP) and oxidative stress
      markers (MDA, TAC) will be determined in cord blood as well.
    

Intervention name(s): vitamin D3 (1000 IU); Vitamin D3 (2000 IU)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Vitamin D; pregnancy
Effects of Different Types of Carbohydrates in Snacks and Beverages on Glycemia, Insulinemia and Appetite.
Condition: Pre Diabetes; Obesity
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      The aim of the study is to describe the glycemic, insulinemic and appetitive responses to
      liquid and solid foods where either soluble fiber or maltodextrin are used as the
      carbohydrate substrate.
    

Detailed description: 
      Asia has the unenviable reputation as being the epicenter for type 2 diabetes. The Asian
      phenotype has been shown to be most susceptible to diabetes than Caucasians. More
      importantly, the transition from prediabetes to diabetes is more drastic and severe in
      Asians. The glycemic index (GI) was first introduced in 1981 as a classification of the blood
      glucose raising potential of carbohydrate foods. There is substantial evidence suggesting
      that consumption of low glycemic index (GI) foods minimize blood glucose fluctuations, and
      help in the prevention and management of diabetes and prediabetes. Given the rising incidence
      of prediabetes and diabetes in Asia, dietary interventions to complement pharmacological
      management of diabetes are increasingly being encouraged. The majority of studies on GI and
      Glycemic Response (GR) have been conducted on Caucasian populations. Asians have been shown
      to have a greater GR to the same food compared to Caucasians. Simple dietary modification
      such as increasing dietary fiber in a food has been shown to reduce GR. However, it is
      unclear if a palatable, low-viscous, soluble fiber and maltodextrin have comparable effect.
      Although viscous insoluble fiber has been shown to also suppress appetite, it was unclear if
      similar effects could be obtained when it is replaced with soluble fiber. Using the
      continuous glucose monitoring system (CGMS), Henry and his colleagues have demonstrated that
      exchanging high-GI bread with a low-GI bread could improve the 24h glucose profile. More
      recently investigators have shown, using the CGMS, that the consumption of a low GI breakfast
      and afternoon snack was capable of attenuating 24-hour blood glucose profiles, minimizing
      glycemic excursions and reducing food intake in healthy Asian males. These simple dietary
      interventions appear to be an acceptable approach in improving overall glycemia and energy
      balance in Asians.
    

Intervention name(s): Soluble corn fiber; maltodextrin
Intervention type(s): Other; Other
Intervention description(s): soluble corn fiber; maltodextrin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized
Masking: Single (Participant)
Primary purpose: Other
High Altitude and Exogenous Carbohydrate Oxidation
Condition: Glucose Metabolism; High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      Recent studies have reported that oxidation of exogenous carbohydrate is reduced under acute
      hypobaric hypoxic (high altitude; HA) conditions compared to normoxia (sea level; SL) in
      native lowlanders. However, the mechanisms by which HA suppresses exogenous carbohydrate
      oxidation are not known. This study will seek to confirm that acute HA exposure decreases
      exogenous carbohydrate oxidation during steady-state aerobic exercise compared to SL, and
      explore if the mechanism inhibiting plasma glucose uptake is insulin dependent or
      independent.
    

Detailed description: 
      This randomized crossover study will examine substrate metabolic responses to ingesting
      supplemental carbohydrate during steady-state aerobic-type exercise at sea level (SL) and
      following acute (~5 h) exposure to HA (4,300 m) conditions in 10 healthy, recreationally
      active adults between the ages of 18-39 yrs. Following a 48-hr muscle glycogen normalization
      period, volunteers will complete 80-min of metabolically-matched, steady-state aerobic
      exercise on a treadmill, and consume 145 g of glucose (1.8 g·min-1) at SL and HA. Treadmill
      exercise will be performed at the same absolute workload, with speed and grade being the same
      at SL and HA to induce the same absolute workload between phases. SL and HA trials will occur
      in the US Army Research Institute of Environmental Medicine (USARIEM) hypobaric chamber and
      will be separated by a minimum 7-d washout period between each protocol day. 6-6-[2H2]
      glucose will be used as a tracer to assess glucose turnover. Indirect calorimetry, breath
      sampling for 13C/12C expired in CO2, and urine collections will be used to determine
      carbohydrate, fat, and protein oxidation during exercise at SL and HA. Serial blood draws
      will be collected during each trial to assess endocrine and circulating substrate responses
      to exercise, carbohydrate, and hypoxia. Muscle biopsies will be collected before and after
      steady-state exercise to examine intramuscular glucose transport expression and
      translocation, glycogen status, and activity enzyme intermediates in aerobic and anaerobic
      energy metabolism.
    

Intervention name(s): Sea Level; High Altitude
Intervention type(s): Other; Other
Intervention description(s): Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL; Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Perilla Extract on Improvement on Gastrointestinal Discomfort
Condition: Abdominal Pain/ Discomfort; Slightly Constipation
MeSH terms: Constipation; Abdominal Pain
Study type: Interventional

Summary: 
      In the current study the effects of proprietary Perilla frutescens leaf extract in comparison
      to Maltodextrin, a fully digestible carbohydrate (placebo control), on gastrointestinal
      discomfort and bowel function were investigated. The study was performed double-blind and
      placebo-controlled with a 4 week intervention period. Study products were taken two times
      daily (each one capsule before breakfast and dinner).
    


Intervention name(s): Perilla extract; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Gastrointestinal discomfort; Perilla frutescens; bloating; abdominal discomfort; human study; healthy subjects
Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profiles of UCB5857 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to investigate the safety and tolerability of UCB5857.
    


Intervention name(s): UCB5857; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Active Substance: UCB5857
Pharmaceutical Form: Capsule
Concentrations: 5 mg, 10 mg, 20 mg, 30 mg, 50 mg, 100 mg
Route of Administration: Oral Use; Active Substance: Placebo
Pharmaceutical Form: Capsule
Concentrations: 5 mg, 10 mg, 20 mg, 30 mg, 50 mg, 100 mg
Route of Administration: Oral Use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Magnesium Chloride Versus Placebo in Patients Who Have Had a Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of six intravenous (IV) infusions of
      magnesium chloride versus placebo in patients who have residual muscle weakness from a stroke
      that occurred three months to four years ago.
    

Detailed description: 
      The hypothesis being tested is that these six treatments will improve muscle weakness and
      lead to an improvement in functioning/activities of daily living as measured by the 100-point
      Barthel index, three months after their last treatment versus their baseline measure, and
      that the mean difference between the treatment and placebo groups of patients will be at
      least three points in this index.
    

Intervention name(s): Magnesium Chloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): An infusion of magnesium chloride will be given over 4 to 10 minutes in patients breathing 100% oxygen; A saline placebo will be given as an infusion (six infusions over a three week period) in a double blind manner with the active test agent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: A stroke that occurred three months to four years ago
Topotecan, High-Dose Cyclophosphamide, Carboplatin, and an Autologous Peripheral Blood Cell Transplant in Treating Patients With Recurrent Ovarian Cancer or Primary Peritoneal Cancer
Condition: Ovarian Cancer; Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Giving colony-stimulating factors, such as G-CSF help stem cells move from the
      patient's bone marrow to the blood so they can be collected and stored. Combination
      chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem
      cells are returned to the patient to replace the blood-forming cells that were destroyed by
      the chemotherapy.

      PURPOSE: This randomized trial is studying the side effects and best dose of topotecan when
      given together with high-dose cyclophosphamide, and carboplatin followed by an autologous
      peripheral blood stem cell transplant in treating patients with recurrent ovarian cancer or
      primary peritoneal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the maximum tolerated dose of topotecan hydrochloride combined with
           high-dose cyclophosphamide and carboplatin in the setting of autologous peripheral blood
           stem cell transplantation for relapsed, recurrent, or persistent ovarian epithelial or
           primary peritoneal cavity cancer.

        -  To assess the toxicity of this regimen.

      OUTLINE: This is a dose escalation study of topotecan.

        -  Autologous hematopoietic stem cell collection: Patients receive filgrastim
           subcutaneously (SC) daily for 5 days. Patients undergo leukapheresis per standard
           practice until a minimum of 2 x10^6 CD34+ cells/kg are collected and cryopreserved.

        -  High-dose chemotherapy: Patients receive topotecan hydrochloride IV, cyclophosphamide
           IV, and carboplatin IV over 8 hours on days -6 to -3.

        -  Autologous peripheral stem cell reinfusion: Patients undergo autologous peripheral blood
           stem cell transplantation on day 0. Patients also receive sargramostim SC daily
           beginning on day 5 and continuing until blood counts recover.

      After completion of study therapy, patients are followed monthly for 3 months, every 3 months
      for 2 years, and then every 6 months for 5 years.
    

Intervention name(s): filgrastim; carboplatin; cyclophosphamide; topotecan hydrochloride; autologous hematopoietic stem cell transplantation; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Topotecan
Primary purpose: Treatment
Keywords: peritoneal cavity cancer; ovarian clear cell tumor with proliferating activity; ovarian endometrioid adenocarcinoma; ovarian mixed epithelial carcinoma; recurrent ovarian epithelial cancer; ovarian mucinous cystadenocarcinoma; ovarian serous cystadenocarcinoma; ovarian undifferentiated adenocarcinoma
Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic
      Chagas Disease to get information to optimize drug doses.
    


Intervention name(s): Benznidazole
Intervention type(s): Drug
Intervention MeSH terms: Benzonidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)
Condition: Lewy Body Dementia
MeSH terms: Parkinson Disease; Dementia; Alzheimer Disease; Lewy Body Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomized placebo-controlled trial to evaluate the safety and efficacy of three doses of
      study drug LY3154207 treated for 12 weeks in participants with mild-to-moderate dementia
      associated with LBD (PDD or DLB).
    


Intervention name(s): LY3154207; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson Disease Dementia; Parkinson Disease; Dopamine; Cognition; Lewy Body Dementia; Dementia with Lewy Bodies
Assess the Safety, Tolerability and Pharmacokinetics of AZD5213 After Single and Multiple Ascending Oral Doses in Healthy Young and Elderly Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
      AZD5213 in healthy young and elderly Japanese subjects
    


Intervention name(s): AZD5213; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Four increasing doses for young and two increasing doses for elderly subjects. Subject will receive single dose of AZD5213 oral solution (Day 1) and then start the once daily repeated doses from Day 3 to 12 for 10 days; Placebo solution, single dose (Day 1) and repeated dose from Day 3 to 12 for 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AZD5213; safety; pharmacokinetics; single dose; repeated dose; young; elderly; Japanese; healthy subject
Pepsinogens as the Early Marker of H. Pylori Eradication
Condition: H. Pylori Infection; Gastric Ulcer; Duodnal Ulcer
MeSH terms: Stomach Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      Helicobacter pylori (H. pylori) eradication increases the serum pepsinogen (PG) I/PG II ratio
      and the percentage change in PG I/PG II ratios was found to be a useful marker of H. pylori
      eradication (e.g., the PG method). We studied whether the PG method could be an early
      diagnostic marker of H. pylori eradication even in patients persistently treated with a
      proton pump inhibitor. Sixty-two H. pylori-positive patients underwent H. pylori-eradication
      therapy, followed by treatment with a PPI to cure ulcers. Serum levels of PG I and PG II were
      measured before, at the end of, and at 4 weeks after the eradication therapy. At more than
      one month after the end of treatments, 13C-urea breath test (UBT) was performed. The cut-off
      values of percentage changes in PG I/PG II ratios for the diagnosis of eradication of H.
      pylori were set in proportion to PG I/PG II ratios before eradication in accordance with our
      previous report. Using the results of UBT as the standard, the percentage change in serum PG
      I/PG II ratios is useful as an early diagnostic marker for judgment of H. pylori eradication
      irrespective of PPI treatment.
    


Intervention name(s): serum pepsinogen; urea breath test
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Clinical Trial Evaluating Lumateperone Monotherapy in the Treatment of Bipolar Depression or Major Depressive Disorder
Condition: Bipolar Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, multicenter study to evaluate the
      efficacy and safety of lumateperone monotherapy in the treatment of patients with major
      depressive episodes associated with Bipolar I or Bipolar II Disorder (Bipolar Depression) or
      major depressive disorder (MDD) who also meet the Diagnostic and Statistical Manual of Mental
      Disorder, 5th Edition (DSM-5) criteria for mixed-features. The study consists of a Screening
      Period, a Double-blind Treatment Period, and a Safety Follow-up Period.
    


Intervention name(s): Lumateperone; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Lumateperone 42mg oral capsule; Placebo oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mixed Features
Phase I Single Dose-Escalation Safety Study of Human Glucocerebrosidase (prGCD)
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the
      human glucocerebrosidase gene (GCD)leading to reduced activity of the lysosomal enzyme
      glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (GlcCer)in
      the cells of the monocyte-macrophage system.

      This is the first trial to utilize a recombinant active form of lysosomal enzyme,
      glucocerebrosidase, (human prGCD)which is expressed and purified in a bioreactor system from
      transformed carrot plant root cell line.
    


Intervention name(s): Human Glucocerebrosidase (prGCD)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety of TVP-1012 (1 mg/day) in
      Japanese participants with early Parkinson's disease.
    

Detailed description: 
      This is a multicenter, open-label, long-term, extension, phase 3 study to evaluate the safety
      and efficacy of long-term administration of TVP-1012 at 1 mg for another 26 weeks in
      participants with early Parkinson's disease who have completed the preceding TVP-1012/CCT-001
      (NCT02337725) study.

      Among participants of the TVP-1012/CCT-001 study, those consenting to participate in this
      study prior to complete the preceding study and fulfilling the eligibility criteria will be
      enrolled in this study. From the day after the Visit 8 of the preceding study, participants
      will receive 1 mg of TVP-1012 once daily for 26 weeks in an unblinded manner.
    

Intervention name(s): TVP-1012 1mg
Intervention type(s): Drug
Intervention description(s): TVP-1012 1mg Tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment