bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Interventional Study on Reversibility of Type 2 Diabetes Mellitus With Hypocaloric Diet
Condition: Type 2 Diabetes Mellitus in Obese
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      T2DM, a chronic progressive disorder has an epidemic status in India. Remission (HbA1c of <
      6.5% without any anti-diabetic medication) of T2DM is achievable with diet modifications in
      recently diagnosed obese T2D individuals. Studies suggest Very Low Calorie Diet (600 -
      800kcal) and Low Calorie Diet-LCD (800 -1000 kcal) using Meal replacers (MR) are helpful. The
      investigators aimed to study the effects of LCD without any anti diabetic medication in
      intervention group and later comparing it with Control group (on standard medical treatment).
    

Detailed description: 
      The objective is to study the effect of LCD in anthropometric , biochemical and NAFLD (Non
      Alcholic Fatty Liver Disease) parameters after 8 weeks and 24 weeks from enrollment.

      Purposive sampling is used to enroll participants in the study. The LCD is a combination of
      one meal replacer and modified major meals. Calculated exchanges of food groups is taken care
      of in the other two major meals and snacks in between. Inorder to adhere compliance clinical
      (at baseline, after 8 weeks, after 24 weeks) as well as virtual visits through whatsapp,
      e-mails, SMS, phone calls (once a week during 8 weeks of intervention and further once a
      month upto 24 weeks) are scheduled. After 8 weeks of LCD, calorie is increased to 1200-1400
      Kcal/day. In the control group the standard medical treatment is continued.

      The data is collected in case report form and analysed using SPSS software by statistician.
    

Intervention name(s): Low Calorie Diet
Intervention type(s): Other
Intervention description(s): 800-1000 Kcal/day
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 2 Diabetes Mellitus, Low Calorie Diet, Meal Replacer
Pharmacokinetics and Pharmacodynamics of MK-8245 in Participants With Type 2 Diabetes (MK-8245-012)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, pharmacokinetics, and glucose lowering
      activity of MK-8245 in participants with type 2 diabetes. The primary hypothesis of the study
      is that after 4 weeks of treatment, MK-8245 produces a greater reduction in 24 hour weighted
      mean glucose (WMG) from baseline than placebo.
    


Intervention name(s): MK-8245; Comparator: placebo
Intervention type(s): Drug; Drug
Intervention description(s): MK-8245 50 mg twice daily for 28 days; matching placebo to MK-8245 twice daily for 28 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 Combined With Docetaxel in Patients With Advanced Solid Tumors
Condition: Advanced Neoplastic Disease
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To determine the dose limiting toxicity (DLT), the maximum administered dose (MAD) and the
      maximum tolerated dose (MTD) of AVE8062 and docetaxel in combination administered
      sequentially on D1 & D2 respectively every 3 weeks in patients with advanced solid tumors.

      Secondary Objectives:

        -  To define the overall safety profile of the combination.

        -  To characterize the pharmacokinetic (PK) profile of AVE8062 and docetaxel when
           administered in combination.

        -  To evaluate anti-tumor activity of the combination.

        -  To evaluate potential predictive biomarkers.

      The study includes a tumoral pharmacogenomic sub-study conducted in a subset of sites. The
      objective to analyse a set of biological biomarkers in order to identify a potential
      predictive signature of efficacy for AVE8062 in combination with docetaxel.
    

Detailed description: 
      The duration of study for each patient will include 4-week screening phase prior to first
      inclusion of study drug, 21-day study treatment cycles, end of treatment visit and follow-up
      phase. Each patient will be treated until disease progression, unacceptable toxicity or other
      study discontinuation criteria.
    

Intervention name(s): AVE8062; Docetaxel
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:Solution for infusion
Route of administration: Intravenous; Pharmaceutical form: solution for infusion
Route of administration: Intravenous
Other intervention name(s): Ombrabulin; XRP6976
Intervention MeSH terms: Docetaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison of Desflurane vs. Sevoflurane and the Time to Awakening and the Incidence and Severity of Cough
Condition: Surgery; Anesthesia
Study type: Interventional

Summary: 
      Goals for ambulatory surgery include providing optimal surgical conditions while ensuring a
      rapid early recovery without side effect. Dexter et al1 concluded in a meta-analysis that
      Desflurane can reduce the extubation time when compared to Sevoflurane. This potential
      benefit of Desflurane can be especially attractive in short ambulatory cases performed with
      general anesthesia with a laryngeal mask airway.

      Although some studies have not shown a difference on perioperative cough and laryngospasm
      between Desflurane and Sevoflurane at clinically relevant doses.It has been reported in the
      literature that Desflurane causes cough4 and many providers avoid using Desflurane with a LMA
      (laryngeal mask airway) in the ambulatory setting. In this study we will also evaluate, as a
      secondary outcome, the presence and severity of perioperative cough and laryngospasm.

      Previous investigators have demonstrated a more rapid resumption of normal daily activities
      after ambulatory surgery in patients anesthetized with Desflurane when compared with
      Sevoflurane.these investigators suggested a better quality of recovery when Desflurane is
      used probably due to a lower lipid solubility of Desflurane. We will also evaluate quality of
      recovery as a secondary outcome using a validated instrument.

      Significance:

        1. A more rapid awakening, especially, in a fast and high turnover cases that are performed
           with LMA can lead to a more cost effective utilization of operating room time

        2. It has been reported that Desflurane causes more cough than Sevoflurane and
           Anesthesiologists avoid using Desflurane with LMA cases, this study will reinforce that
           there is no difference.
    


Intervention name(s): Desflurane; Administration of Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): Administratino of Desflurane; Administration of Sevoflurane
Intervention MeSH terms: Sevoflurane; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: Induction; Coughing; Anesthesia
Immediate Compared With Delayed Chemotherapy in Advanced Colorectal Cancer Without Signs or Symptoms of Disease
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known which treatment regimen is more effective for colorectal cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of immediate with delayed
      fluorouracil plus leucovorin in treating patients with advanced colorectal cancer without
      signs or symptoms of disease.
    

Detailed description: 
      OBJECTIVES: I. Compare survival and quality of life in asymptomatic patients with advanced
      colorectal cancer randomized to immediate fluorouracil/leucovorin (5-FU/CF) vs. 5-FU/CF
      delayed until onset of symptoms.

      OUTLINE: Randomized, unblinded study. Arm I: Single-Agent Chemotherapy with Drug Modulation.
      Fluorouracil, 5-FU, NSC-19893; with Leucovorin calcium, CF, NSC-3590. Arm II: Observation
      followed by Single-Agent Chemotherapy with Drug Modulation. Clinical observation until
      symptomatic; followed by 5-FU; with CF.

      PROJECTED ACCRUAL: 144 patients will be entered over 4 years.
    

Intervention name(s): fluorouracil; leucovorin calcium
Intervention type(s): Drug; Drug
Intervention description(s): 425 mg/m2 IV by bolus injection daily for 5 consecutive days q 28 days; 20 mg/m2 IV - number of cycles is determined by patient and physician
Intervention MeSH terms: Leucovorin; Fluorouracil; Calcium; Levoleucovorin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer
The Effect of Montelukast on Difficulty in Breathing After Exercise in Pediatric Patients (MK0476-377)(COMPLETED)
Condition: Exercise-induced Bronchoconstriction (EIB)
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will see if there is a change in breathing after exercising when the child
      receives study drug ( montelukast or placebo). Breathing will be measured by a spirometer
      before exercising and measured again several times after exercising.
    


Intervention name(s): Comparator: montelukast sodium; Comparator: Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug
Intervention description(s): Patients 4-5 years: 4 mg Montelukast chewable tablet daily
Patients 6-14 years: 5 mg chewable tablet daily; Patients 4-5 years: 4 mg Pbo chewable tablet daily
Patients 6-14 years: 5 mg Pbo chewable tablet daily
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Joint Coordination to Facilitate the Transition From Sick Leave to Employment
Condition: Long Term Sick Leave; Absent-mindedness
Study type: Interventional

Summary: 
      GESAM is a randomized controlled intervention study that addressed women and men on long-term
      sick leave in Uppsala County. Participants which are on sick leave due to mental illness
      and/or pain and were expected to reach the time limit within the in health insurance will be
      offered to participate in an intervention.

      Those how give informed consent will be randomly assigned one of the following groups: 1)
      informing and motivating intervention with insurance officer 2) control group. The main
      purpose of the study is to facilitate the return to work (preventing a return to the public
      health insurance) during the project period.
    


Intervention name(s): Motivational interviewing
Intervention type(s): Behavioral
Intervention description(s): Motivational interviewing with insurance officer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Vitamin C on Hyperoxia-Induced Reduction of Retinal Blood Flow
Condition: Ocular Physiology; Regional Blood Flow
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      High arterial blood oxygen tension leads to vasoconstriction of retinal vessels, possibly
      related to an interaction between reactive oxygen species and endothelium-derived vasoactive
      factors. Vitamin C is a potent antioxidant capable of reversing endothelial dysfunction due
      to increased oxidant stress. Vitamin C appears to have vasodilatory properties, but the
      underlying mechanisms are not well understood.

      In the present study we hypothesized that hyperoxic vasoconstriction of retinal vessels could
      be diminished by vitamin C.

      Ocular blood flow will be determined by non-invasive methods, including laser Doppler
      velocimetry and the Zeiss retinal vessel analyser.
    


Intervention name(s): vitamin C (Mayrhofer) 24mg/min i.v. for 64 min; Placebo; 100% O2 (AGA) two times for 12 min
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Substance: Ascorbic acid (Mayrhofer) Manufacturer: Mayrhofer, Linz, Austria Dosage form: i.v. Dosage: 24mg/min over 64 min Dosage reference: Ting HH 1996; Substance: Physiologic saline solution 0.9% (placebo) Dosage form: i.v. Dosage: 24ml/min over 64 min; Substance: 100% oxygen (AGA, Vienna, Austria, gases for human use) Manufacturer: AGA, Vienna, Austria, gases for human use Dosage form: Inhalation through an oxygenmask over a period of 12 minutes two times per study day.
Dosage reference: Strenn K 1997
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: vitamin C; retinal blood flow; intraocular pressure; retinal vessel diameter
Insulin Resistance in the Control of Intestinal Lipid Metabolism
Condition: Insulin Resistance; Type 2 Diabetes
MeSH terms: Insulin Resistance
Study type: Observational

Summary: 
      America's preferential consumption of high-fat/high-sugar foods is a driving force in the
      current epidemic of obesity and insulin resistance. Recent scientific observations suggest
      that the taste of food may play a role in how the body processes the food eaten in a meal.
      The intestine may play a central role in all aspects of dietary fat metabolism, from initial
      encounter with taste buds in the mouth to eventual triglyceride (TG) storage in the body.

      The investigators hypothesize that elevated blood fats in insulin resistance are a result of
      elevated intestinal-TG secretion and poor communication of this organ to the rest of the body
      after meals.

      In this study, meal feeding and sensory studies will be performed to determine whether the
      mechanism of taste-associated intestinal signaling leads to higher levels of blood fats after
      meals in 24 healthy, insulin resistant and type 2 diabetic subjects. Individuals will consume
      special meals the night before the tests and participate in sensory tests in the morning to
      analyze the effect of taste.

      The goal of this work is to understand how insulin resistance may cause impaired signaling
      between the taste buds and the intestine to result in an elevation in blood lipids, which
      increases the risk for other chronic diseases. This study will generate data for a future
      study to understand how diabetes treatment affects this process.
    

Detailed description: 
      Subjects will participate in two screening visits to determine insulin resistance status and
      then participate in a single in-patient, clinical research center test.

      There are no drugs used in this study. The goal is to test the physiological response to
      eating.
    

Intervention name(s): taste tests
Intervention type(s): Behavioral
Intervention description(s): Subjects undergo "sham feeding" in which they take a bit of food, chew it and spit it out. This test should engage sensory mechanisms which may affect intestinal signaling.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy, insulin resistant and type 2 diabetic subjects.
      
Biospecimen description: 
      DNA will be collected for future determination of genotypes that impact taste senstivity
Study of Desvenlafaxine in Treating Major Depressive Disorder.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate if the effectiveness of desvenlafaxine
      succinate sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine
      hydrochloride enteric-coated capsule (60 mg/day) in adult patients with major depressive
      disorder.
    

Detailed description: 
      This is a multicenter study to evaluate if the effectiveness of desvenlafaxine succinate
      sustained-release tablet (50 mg/day) used for 8 weeks is not inferior to duloxetine
      hydrochloride enteric-coated capsule (60 mg/day) in adult patients with major depressive
      disorder. A total of 400 subjects will be randomly allocated to experimental arm
      (desvenlafaxine succinate sustained-release tablet) and active comparator arm (duloxetine
      hydrochloride enteric-coated capsule) in a 1:1 ratio.
    

Intervention name(s): Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo; Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule; Duloxetine Hydrochloride Enteric-coated Capsule Placebo; Duloxetine Hydrochloride Enteric-coated Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Desvenlafaxine Succinate Sustained-Release Tablet 50 mg+Duloxetine Hydrochloride Enteric-coated Capsule Placebo 60 mg orally once daily for 8 weeks.; Desvenlafaxine Succinate Sustained-Release Tablet Placebo 50mg +Duloxetine Hydrochloride Enteric-coated Capsule 60mg orally once daily for 8 weeks,; Duloxetine Hydrochloride Enteric-coated Capsule Placebo 30 mg orally once daily for 1 week after 8-weeks treatment.; Duloxetine Hydrochloride Enteric-coated Capsule 30mg orally once daily for 1 week after 8-weeks treatment.
Intervention MeSH terms: Duloxetine Hydrochloride; Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Desvenlafaxine
Preventing Anxiety Disorders in Urban Youth
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study will determine the effectiveness of a cognitive-behavioral group therapy program
      in preventing anxiety disorders in at-risk children exposed to community violence.
    

Detailed description: 
      Community violence is a major public health problem in low-income, urban communities. The
      mental health impact of living in a violent community is significant, particularly for
      children. Community violence exposure is associated with various symptoms of anxiety.
      Unfortunately, little research on the prevention of community-related anxiety in youth has
      been conducted. This study involves a school-based prevention and cognitive behavioral
      therapy program that will involve predominantly African American children who live in urban
      areas and are at risk for developing anxiety disorders.

      Children in this study will be randomly assigned to either an anxiety prevention and early
      intervention group or a nonintervention group for approximately 3 months. Child, parent, and
      teacher assessments of anxiety symptoms will be made at the end of the study and at a 6-month
      follow-up visit.
    

Intervention name(s): Cognitive-behavioral group therapy
Intervention type(s): Behavioral
Intervention description(s): School-based anxiety preventive intervention (cognitive-behavioral group therapy) originally designed for Australian children that was culturally and contextually modified for inner-city children exposed to community violence. Participants received the weekly intervention and rewards for participating in the assessments.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Violence; School based; Urban Youth; Prevention; Community
A Study in Healthy Participants Evaluating the Absorption of a BMS-986205 Tablet Into the Bloodstream Compared to a Reference Tablet
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, randomized study in healthy participants to evaluate the
      absorption of a BMS-986205 tablet into the bloodstream compared to a reference tablet.
      Eligible participants will be randomly assigned to 1 of 2 treatment sequences and will
      receive a single, oral dose of BMS-986205 twice over 22 days. Participants must remain at the
      clinical facility for the duration of the study.
    


Intervention name(s): BMS-986205 reference tablet; BMS-986205 tablet with free base
Intervention type(s): Drug; Drug
Intervention description(s): Single, 100 mg oral dose.; Single, 100 mg oral dose.
Intervention MeSH terms: Linrodostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Abdominal Wall Activity on the Responses to Meal Ingestion
Condition: Healthy
Study type: Interventional

Summary: 
      Meal ingestion induces sensations that are influenced by a series of conditioning factors.
      Aim: to determine the effect of abdominal wall activity on the responses to a standard probe
      meal. Study in healthy subjects comparing postprandial digestive sensations (abdominal
      bloating and digestive well-being) during consecutive maneuvers of diaphragmatic contraction
      (i.e. descent) versus diaphragmatic relaxation (i.e. ascent) in a cross-over randomized
      design. Primary outcome: effect of somatic maneuvers on abdominal bloating sensation;
      secondary aim: effect on digestive well-being.

      Participants (16 women) will be instructed to eat a standard dinner the day before, to
      consume a standard breakfast at home after overnight fast, and to report to the laboratory,
      where the test meal will be administered 4 h after breakfast. Studies will be conducted in a
      quiet, isolated room. Participants will be taught to produce diaphragmatic contraction and
      visible abdominal distention. A probe meal up to maximal satiation will be administered to
      induce abdominal fullness/bloating sensation; immediately after ingestion, bloating sensation
      (from 0 to 10) and digestive well-being (from -5 to +5) will be scored during 8 alternating
      episodes (30 s each) in random sequence of diaphragmatic contraction (abdominal distension)
      versus diaphragmatic relaxation.
    


Intervention name(s): Diaphragmatic contraction; Diaphagmatic relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sequential periods (30 s) of voluntary diaphragmatic contraction after meal ingestion; Sequential periods (30 s) of voluntary diaphragmatic relaxation after meal ingestion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: meal ingestion; postprandial responses; hedonic sensations; homeostatic sensations; abdominal wall activity; abdominal distension