bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of EGT0001442 in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the effect of EGT0001442 on fasting plasma glucose
      after 28 days of treatment in subjects with type 2 diabetes.

      The study also assessed the pharmacokinetics, safety and tolerability of EGT0001442, the
      effect on weight and HbA1c as well as the effect EGT0001442 has on the amount of glucose
      produced in the body by the urine.
    

Detailed description: 
      This was a phase 2 study to evaluate the efficacy of

      EGT0001442. The study included two segments:

      Segment 1 was a single center, open labeled, ascending dose study in 4 groups of 5 diabetic
      subjects per group who received 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily
      for 28 days. The subjects were in clinic for the first 3 days for safety and PK evaluation.

      Segment 2 was a multi-center, double-blind, placebo-controlled parallel group study. One
      hundred and thirty one subjects in 5 parallel groups of approximately 25 diabetic subjects
      per group were randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day or
      placebo once daily for 28 days in an outpatient setting.
    

Intervention name(s): EGT0001442; Placebo capsules to match EGT0001442
Intervention type(s): Drug; Drug
Intervention description(s): Segment 1 is a single center, open labeled, ascending dose study in diabetic subjects who will receive 5, 10, 20, or 50 mg of EGT0001442 capsules orally once daily for 28 days.
Segment 2 is a multi-center, double-blind, placebo-controlled parallel group study. Diabetic subjects will be randomly assigned to receive oral EGT0001442 at 5, 10, 20, or 50 mg/day for 28 days.; Segment 1: Not applicable.
Segment 2: Diabetic subjects will be randomly assigned to receive oral placebo once daily for 28 days.
Other intervention name(s): Human SGLT2 inhibitor; Human SGLT2 inhibitor
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type 2
Interruption of Dorsal Visual Stream Using TMS
Condition: Healthy
Study type: Interventional

Summary: 
      Trans Cranial Magnetic Stimulation (TMS) over dorsal visual system will disturb the ability
      to identify objects with decreased level of fragmentation
    

Detailed description: 
      The participants performed two tasks under three different TMS conditions: no TMS, 10Hz TMS
      for over the dorsal stream (PO3 EEG site) or over the vertex.

      First they performed a perceptual closure task which asked them to identify an object in a
      series of six progressively less degraded pictures.

      Then, they also performed a control task previously shown not to be mediated by the LOC and
      not to be impaired in schizophrenia: The perception of illusory contours.
    

Intervention name(s): No TMS intervention; TMS over the PO3 EEG site; TMS over the vertex
Intervention type(s): Device; Device; Device
Intervention description(s): In the "no TMS" condition, no simulation was given and no coil placed near participants' heads.; 10Hz TMS over the dorsal stream (PO3 EEG site); 10Hz TMS for over vertex.
Other intervention name(s): MAGSTIM biphasic stimulator; MAGSTIM biphasic stimulator
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Normal Controls
Malnutrition In Non-Celiac Wheat Sensitivity Patients
Condition: Non-Celiac Wheat Sensitivity
MeSH terms: Malnutrition; Hypersensitivity
Study type: Observational

Summary: 
      Non-celiac gluten sensitivity (NCGS) or 'wheat sensitivity' (NCWS) is included in the
      spectrum of gluten-related disorders. No data are available on the prevalence of low bone
      mass density (BMD) in NCWS. Our study aims to evaluate the prevalence of malnutrition in NCWS
      patients and search for correlations with other clinical characteristics. This prospective
      observation study will include 90 NCWS patients with irritable bowel syndrome (IBS)-like
      symptoms, 90 IBS and 90 celiac controls. Patients will be recruited at the Internal Medicine
      and at the Gastroenterology Units of the University of Palermo. Elimination diet and
      double-blind placebo controlled (DBPC) wheat challenge proved the NCWS diagnosis. All
      subjects underwent nutritional parameters measurement, duodenal histology, Human Leucocyte
      Antigen (HLA) DQ typing and body mass index (BMI) evaluation.
    

Detailed description: 
      Celiac disease (CD) has been reported to increase the risk of malnutrition due to
      malabsorption. More recently, it has been reported that a consistent percentage of the
      general population consider themselves to be suffering from problems caused by wheat and/or
      gluten ingestion, even though they do not have CD or wheat allergy. This clinical condition
      has been named Non-Celiac Gluten Sensitivity' (NCGS). In a previous paper the investigators
      suggested the term 'Non-Celiac Wheat Sensitivity' (NCWS), since it is not known what
      component of wheat causes the symptoms in NCGS patients, and the investigators also showed
      that these patients had a high frequency of coexistent multiple food hypersensitivity. That
      previous study also showed a percentage of NCWS patients had weight loss and anemia: whether
      these depended on the intestinal malabsorption or not remains unclear. As yet no data are
      available on the presence and prevalence of low bone mass density (BMD) in NCWS patients. The
      aims of the present study is 1) to investigate the prevalence of malnutrition in NCWS patient
      and 2) to search for a possible correlation with other clinical characteristics, in
      particular the body mass index (BMI), of NCWS patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will include consecutive adult patients with irritable bowel syndrome (IBS)-like
        clinical presentation, according to Rome II criteria, and a definitive diagnosis of NCWS,
        referred at the Internal Medicine and at the Gastroenterology Units of the University
        Hospital of Palermo, between may 2015 and may 2017.
      
Biospecimen description: 
      Biopsy specimens will be obtained from the bulb and the second duodenal portion
    
Keywords: n Non-Celiac Wheat Sensitivity; Malnutrition; Celiac disease; Irritable Bowel Syndrome
Mothers in Motion Program to Prevent Weight Gain in WIC Mothers (MIM)
Condition: Overweight; Obesity
MeSH terms: Overweight; Weight Gain
Study type: Interventional

Summary: 
      Mothers in Motion will draw on the successes of the pilot intervention of the same name and
      will promote healthy lifestyle behavior changes (eating more fruits and vegetables,
      increasing physical activity, dealing with stress) in low-income WIC mothers of young
      children. The intervention group's weight change (difference between the initial enrollment
      and 3 months post intervention) will differ from the control group's weight change by an
      average of at least 2.8 pounds.
    

Detailed description: 
      Mothers in Motion will draw on the successes of the pilot intervention of the same name and
      will promote healthy lifestyle behavior changes (eating more fruits and vegetables,
      increasing physical activity, dealing with stress) in low-income WIC mothers of young
      children. Both treatment groups will receive usual WIC care (nutrition counseling and similar
      services). The control group will receive generic printed health and nutrition materials to
      read at their own pace if they wish. The intervention group will watch the culturally
      sensitive DVD chapters according to a study calendar, complete action plan worksheets, and
      call in to peer support group teleconferences to discuss the DVD chapter contents. The
      teleconferences will be led by moderators trained in motivational interviewing (MI) and group
      facilitation. Participants will complete phone interviews and provide body weight
      measurements at baseline (T1), immediately after (T2) and 3 months after (T3) the
      intervention time period. T3 body weight will be the primary outcome.
    

Intervention name(s): Lifestyle Counseling
Intervention type(s): Behavioral
Intervention description(s): The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.
Other intervention name(s): Motivational Interviewing
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Intervention
A Study of The Excretion Balance, Pharmacokinetics and Metabolism of A Single Oral Dose of [14C]-Labeled RO4917523 in Healthy Male Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single-center, open-label study will assess the excretion balance, pharmacokinetics and
      metabolism of oral [14C]-labeled RO4917523 in healthy male volunteers. Subjects will receive
      a single oral dose of [14C]-labeled RO4917523 and an intravenous tracer dose of [13C]-labeled
      RO4917523 on Day 1. In-clinic period will be up to 18 Days. Anticipated time on study is up
      to 15 weeks.
    


Intervention name(s): RO4917523; RO4917523
Intervention type(s): Drug; Drug
Intervention description(s): [14C]-labeled RO4917523, single oral dose; [13C]-labeled RO4917523, single intravenous tracer dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease Psychosis
Condition: Parkinson Disease Psychosis
MeSH terms: Parkinson Disease; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate the safety and tolerability of SEP-363856 in subjects with Parkinson's
      Disease Psychosis. This study is accepting male and female participants 55 years of age and
      older who have been diagnosed with Parkinson's Disease. This study will be conducted in 24
      study centers in the United States.

      The study will last approximately 21 weeks.
    

Detailed description: 
      This is a multicenter, randomized, parallel-group, placebo-controlled study evaluating the
      efficacy, safety, and tolerability of double-blind SEP-363856 flexibly dosed at 25, 50, or 75
      mg/day for 6 weeks followed by 12 weeks of open-label extension of SEP-363856 flexibly-dosed
      at 25, 50, or 75 mg/day in male and female subjects ≥ 55 years of age with a clinical
      diagnosis of PDP. The study will randomize approximately 36 subjects to 2 treatment groups in
      a 2:1 ratio (approximately 24 subjects to SEP-363856 and 12 to placebo). The study will
      consist of 4 periods: Screening/Washout Period (up to 14 days prior to Double-blind
      Treatment), Double-blind Treatment Period (6 weeks), Open-label SEP-363856 Treatment Period
      (12 weeks), and Follow-up Period (1 week after last dose) as shown in the following figure.
      All postBaseline clinic visits will have a window of ± 2 days relative to the date of the
      Baseline visit (Visit 3).
    

Intervention name(s): SEP-363856; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): SEP-363856 (25, 50, or 75mg/day); Placebo once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease Psychosis
Sex and Exercise-mode Differences in Post Exercise Blood Pressure and Heart Rate Variability Responses During Workday
Condition: Hemodynamic; Exercise
Study type: Interventional

Summary: 
      The present study compared the acute effects of Sex and exercise mode on subsequent blood
      pressure (BP) and heart rate variability (HRV) responses during daily work in healthy adults.
      All subjects did 3 sessions: aerobic exercise on a treadmill, resistance exercise at the gym
      and a seated control session.
    

Detailed description: 
      Resting blood pressure and heart rate variability are simple and non-invasive methods to
      evaluate cardiovascular risk after different exercise sessions. Thus, exercise can reduce
      these risk factors in the short and long term, but these responses can be different between
      sex in different exercise sessions.
    

Intervention name(s): Aerobic exercise; Resistance exercise; Control session
Intervention type(s): Other; Other; Other
Intervention description(s): 30 minutes of treadmill exercise at 60-70% of heart rate reserve; 30 minutes of circuit resistance session at 40% of 1 maximun repetition test; 30 minutes seated resting
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 20 healthy adults, public servants (9W and 11M), randomly underwent three experimental sessions in early morning prior to their work routine: a circuit resistance session at 40% of 1RM, a treadmill exercise session at 60-70% of heart rate reserve and a resting control session.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Post-exercise hypotension; Aerobic Exercise; Resistance Exercise; Autonomic Stress; Heart Rate Variability; Sex difference
Is Insulin Resistance and/or Glucose Intolerance Pathogenetic in the Development of a Reduced Incretin Effect
Condition: Insulin Resistance; Glucose Intolerance
MeSH terms: Insulin Resistance; Glucose Intolerance
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether there is a causal relationship between
      insulin resistance and/or glucose intolerance in the development of a defect incretin effect.
    

Detailed description: 
      In this study we are going to examine the incretin effect before and after the development of
      insulin resistance and/or glucose intolerance. The incretin effect is the increased insulin
      response seen after an oral as apposed to an intravenous glucose challenge with identical
      plasma glucose profiles. This insulin enhancing effect is greatly reduced in type 2 diabetes.

      Since the development of type 2 diabetes is preceded by insulin resistance and glucose
      intolerance we wanted to examine the incretin effect in the early stages of type 2 diabetes.

      To do this, we want to induce insulin resistance and/or glucose intolerance. This is achieved
      by 5 days of treatment with dexamethasone.

      The incretin effect in this study will be examined by 3 investigations prior to the treatment
      and 3 days following the treatment.

      Day 1: Oral glucose challenge with 75 g of glucose.

      The subject is asked to drink 75g of glucose suspended in 300mL of water. During the 4 hours
      of the test, we draw blood at various times during the study to determine the concentration
      of: Glucose, GLP-1, GIP, Glucagon, Insulin and c-peptide.

      Day 2: Intravenous glucose

      We duplicate the glucose curve obtained from day 1. We also draw blood during this test to
      the same end as in day 1.

      Day 3: Mixed meal.

      The subjects are served a mixed meal. During this 4 hour test, we draw blood to examine the
      response to a standardized meal. The test involves sampling blood as described for the other
      days.
    

Intervention name(s): Dexamethasone
Intervention type(s): Drug
Intervention description(s): 2mg morning and night for 5 days.
Intervention MeSH terms: Dexamethasone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: incretin effect; type 2 diabetes; GLP-1; GIP; dexamethasone
Breakfast and Energy Expenditure in Young Women
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this research is to determine if body composition influence the effect of
      breakfast composition on postprandial (post-meal) hunger, metabolic and energy expenditure
      response in normal weight, overweight, and obese young women.
    


Intervention name(s): Control; Omega 3 fatty acids
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.; Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Sequenced vs. Integrated Delivery of Treatment for Adolescent Depression and SUD
Condition: Adolescent; Depression; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether it is more effective to treat adolescents,
      with diagnoses of both depression and substance use disorder, with a treatment addressing the
      substance use first and then treating the depression or to first treat the depression and
      then treat the substance use or whether treating both disorders simultaneously is most
      effective.

      It is expected that treatment of both disorders at the same time will be the most effective.
    

Detailed description: 
      Comorbidity is a well established aspect of adolescent psychopathology. The majority of
      adolescents entering treatment have more than one condition. This study will evaluate service
      delivery methods of integrating empirically supported interventions for depression and
      non-nicotine substance use disorders (SUD)in an effort to improve treatment engagement,
      response, and maintenance of gains. The two examined interventions are the Adolescent Coping
      With Depression course (ACWD) and Functional Family Therapy (FFT).

      This study will expand upon previous research by systematically treating both depression and
      SUD. Over a 5 year period, 180 adolescents with depression/SUD and their parents/guardians
      will be recruited in Oregon and New Mexico and randomly assigned to 1 of 3 conditions: (a)
      FFT followed by ACWD, (b) ACWD followed by FFT, or (c) an intervention combining and
      augmenting FFT and ACWD (Integrated Treatment). Each treatment arm will consist of 24
      sessions provided over 20 weeks. Participants will be assessed at intake, after the provision
      of 6, 12 (Mid-treatment), 18 and 24 (Post-treatment)treatment sessions, and at 6 and 12 month
      follow-ups.
    

Intervention name(s): Adolescent Coping With Depression/Functional Family Therapy
Intervention type(s): Behavioral
Intervention description(s): ACWD- Cognitive behavioral group therapy for depressed adolescents FFT - Family therapy to address substance use disorders in adolescents
Other intervention name(s): FFT; ACWD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Treatment efficacy; Family therapy; Teens; Substance abuse; Substance dependence
Comparison of Low Fat and Low Carbohydrate Diets With Respect to Weight Loss and Metabolic Effects
Condition: Obesity
Study type: Interventional

Summary: 
      The investigators will test the hypothesis that a LOW CARB hypocaloric diet will reduce body
      weight over six months more than a LOW FAT hypocaloric diet. In addition to body weight, the
      investigators will measure cardiovascular and metabolic variables and will take blood samples
      in order to determine whether certain metabolites may predict the diet success.
    


Intervention name(s): dietary intervention
Intervention type(s): Behavioral
Intervention description(s): dietary counseling, group teaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cardiac Sarcoidosis and FDG-PET
Condition: Sarcoidosis; Dilated Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Dilated; Sarcoidosis
Study type: Observational

Summary: 
      Sarcoidosis is a multi-systemic inflammatory disorder of unknown cause characterized by the
      formation of non-caseating granulomas in involved organs. Its cardiac involvement may be
      potentially fatal. Although endomyocardial biopsy is required for deﬁnitive diagnosis of
      cardiac sarcoidosis, it is invasive and lacks sensitivity. The specific diagnostic tool for
      cardiac sarcoidosis is far from satisfactory. Recent studies have revealed that FDG-PET with
      under fasting conditions is a useful method for identiﬁcation of cardiac sarcoidosis
      patients. However, to our knowledge, no investigations have been published with regard to FDG
      quantification for the diagnosis and management of cardiac sarcoidosis by PET.
    

Detailed description: 
      Fasting FDG-PET will be performed in all subjects. Serum calcium, C-reactive protein (CRP),
      angiotensin converting enzyme (ACE), lysozyme, and B-type natriuretic peptide (BNP) levels
      will be measured in all patients. All patients will undergo chest X-ray, resting 12-lead ECG,
      transthoracic echocardiography, and 3 types of radionucleotide imaging using Tc-99m sestamibi
      for myocardial perfusion, Ga and FDG for whole-body evaluation. All assessments will be
      conducted within 2 weeks and no sign indicated any change in disease activity of sarcoidosis.
      The patients with cardiac involvement will be treated with 30 mg/day of prednisolone orally
      for the first 4 weeks, then will decrease to a dose of 20 mg/day for the next 4 weeks, and
      will maintain to a dose of 10 mg/day afterwards.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Fasting FDG-PET will be performed in patients with sarcoidosis and age-matched DCM
        patients. Among them, systemic sarcoidosis will be diagnosed clinically and/or
        histologically, and referred for cardiac sarcoidosis. Patients with sarcoidosis will reveal
        cardiac involvement based on guidelines established in 2006 by the Japanese Ministry of
        Health and Welfare. Healthy control subjects will undergo FDG-PET.
Evaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases
Condition: Childhood Rheumatic Diseases
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Interventional

Summary: 
      The aim of our study is to examine possible disease-related changes in dental age and
      mandibular bone morphology in childhood rheumatic diseases.
    

Detailed description: 
      to reveal the changes that can occur in different childhood rheumatic diseases, the treatment
      process of the disease and the drugs used on the dental age and mandible
    

Intervention name(s): Panoramic rad.
Intervention type(s): Radiation
Intervention description(s): In the study, digital panoramic x-rays of the patients will be evaluated and dental age estimation with Willems method and mandibular bone morphometric measurements will be made.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Childhood rheumatic diseases