bioihbjkbjnl/mcl2 huggingface dataset:
Telephone Counseling and Numberless Scales to Overcome Barriers to Adolescent Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      This study tests the feasibility and acceptability of a numberless behavioral digital scale
      (BDS) intervention combined with motivational interviewing (MI) to affect lifestyle changes
      to promote weight loss in adolescents who are obese. Half of the participants will receive
      this intervention, while the other half will use a digital scale along with the standard
      adolescent weight loss program.
    

Detailed description: 
      The proposed pilot project seeks to enhance motivation for lifestyle change in adolescents
      who are obese. It will test a novel intervention that combines modified MI-based counseling
      and BDS. We will test the feasibility of the intervention over a 12-week period, with 24-week
      follow-up compared to use of standard digital scale. All participants will undergo the
      standard adolescent weight loss program, which includes monthly clinic visits with dietary
      and physical activity counseling. The MI intervention will include modified MI, brief weekly
      telephone reinforcement, and use of a BDS. The BDS with its mobile app offers daily feedback
      through colors, daily missions to promote healthy habits, and weekly healthy tips from
      nutritionists. In addition to the primary outcome of feasibility (daily weighing)
      investigators will also explore the intervention's effect on motivation, psychological
      outcomes and various aspects of feasibility and acceptability.
    

Intervention name(s): Numberless BDS; Digital Scale; Modified Motivational Interviewing
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants perform daily weighing using a numberless BDS with feedback from app (color codes, challenges), in conjunction with modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.; Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program; Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Adolescent
BIOAVAILABILITY OF Glimepiride/Extended Release Metformin (GLI/METXR): High Fat Diet Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      The purpose of this study is to evaluate the effect of food intake in bioavailability (BA) of
      the combination Glimepiride/ extended release Metformin GLI/METXR (4/850mg) in healthy
      Mexican volunteers.

      Methods: A prospective, longitudinal, open label, non randomized study, was performed. A
      single oral dose of GLI/METXR (4/850 mg) was administered to 24 health Mexican volunteers 30
      min after a high fat meal.
    

Detailed description: 
      Blood samples were collected before the administration and 0.33, 0.67, 1, 1.5, 2, 2.5, 3,
      3.5, 4, 4.5, 5, 5.5, 6.7, 8, 10, 12, 16, 20, 24 and 30 hours post-administration. Plasma
      concentration of the drug was measured by using HPLC. Plasma concentration of both drugs were
      measured using high-performance liquid chromatography (HPLC). Plasma concentration time
      curves were plotted for each volunteers, and pharmacokinetic parameters (PK) were calculated.
      The pharmacokinetic parameters to be determined are: Cmax, Tmax, AUC0-t, AUC0-inf, TMR, Ke,
      T1 / 2 of glimepiride and metformin. The statistical analysis will be descriptive for plasma
      concentrations with respect to time and the pharmacokinetic parameters of Cmax, Tmax, AUC0-t,
      AUC0-inf, TMR, Ke, T1/2 of glimepiride and metformin. Adverse events were determined using
      clinical and laboratory test results throughout the study.
    

Intervention name(s): Glimepiride/ Extended release Metformin
Intervention type(s): Drug
Intervention description(s): One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose. Patients received a high fat diet 30 min before administration.
Other intervention name(s): GLIMETXR
Intervention MeSH terms: Metformin; Glimepiride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DM2; glimepiride; metformin extended release
Safety and Tolerability of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed as an extension study to the proof-of-concept trial CAIN457A2209 in
      patients with moderate to severe ankylosing spondylitis and aims to provide continuous
      treatment with AIN457 for patients in the core trial, to obtain safety and tolerability
      information. The study will address the evaluation of efficacy following doses of Intravenous
      infusion (IV) of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months
      (Part 1) and based on the risk/benefit balance of AIN457 in ankylosing spondylitis a decision
      was taken to continue dosing for another 6 month period (Part 2).
    


Intervention name(s): AIN457A
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ankylosing spondylitis; IgG1K monoclonal antibody; Interleukin -17A neutralizing
Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Sanford Research/USD proposes to study the combination therapy of oral administration of
      sitagliptin and lansoprazole versus placebo for the preservation of pancreatic beta cells
      still present in patients with recent-onset diabetes and possibly regenerating their beta
      cells, while safely down-regulating the autoimmune response directed against the beta cells.
    


Intervention name(s): Sitagliptin and Lansoprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) or matching placebo
Subjects age 11-17 years at Visit 2 will take 1 capsule once daily
Subjects age 18-45 years at Visit 2 will take 2 capsules once daily; Sitagliptin 50mg and Lansoprazole 30 mg or matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
Other intervention name(s): Januvia; Prevacid; Januvia; Prevacid
Intervention MeSH terms: Sitagliptin Phosphate; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: diabetes; HGB A1C; Beta Cell Regeneration
The Effect of Gabapentin on Thoracic Epidural Analgesia Following Thoracotomy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to investigate the effect of gabapentin on thoracic epidural
      analgesia following thoracotomy, including assessment of both analgesia, pain intensity, pain
      quality and whether or not gabapentin prevents the development of chronic pain conditions
      following thoracotomy.

      The main hypothesis is that gabapentin reduces the proportion of patients who develop a
      persistent pain condition following thoracotomy from 50% to 20%.

      Furthermore gabapentin is expected to reduce both pain intensity measured on a 11-point
      numerical rating scale, usage of epidural infusions of local and/or opioid analgesics,
      morbidity, hospital length of stay, consumption of opioid analgesics and analgesia-related
      side-effects.

      In addition gabapentin is expected to improve postoperative recovery by means of
      postoperative lung function, walking ability, health related quality of life and patient
      satisfaction
    


Intervention name(s): Gabapentin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Preoperatively (2 hours before surgery): 4 gabapentin capsules each containing 300 mg gabapentin (total gabapentin dose 1200 mg)
Postoperative day 1: gabapentin 300 mg x 2 (total gabapentin dose 600 mg)
Postoperative day 2: gabapentin 300 mg x 3 (total gabapentin dose 900 mg)
Postoperative day 3: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)
Postoperative day 4: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)
Postoperative day 5: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg); Preoperatively (2 hours before surgery): 4 placebo capsules
Postoperative day 1: 1 placebo capsule x 2
Postoperative day 2: 1 placebo capsule x 3
Postoperative day 3: 1 placebo capsule x 4
Postoperative day 4: 1 placebo capsule x 4
Postoperative day 5: 1 placebo capsule x 4
Other intervention name(s): Gabapentin "Sandoz" 300 mg
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Gabapentin; Thoracotomy; Pain, Postoperative; Analgesia; Recovery of Function; Quality of Life
Moderately Hypofractionated Conformal Radiation Combined With S-1 for Esophageal Squamous Cell Carcinoma
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II randomized study is to determine the efficacy and toxicities of moderately
      hypofractionated conformal radiation combined With S-1 for esophageal squamous cell
      carcinoma.
    

Detailed description: 
      This Phase II randomized study is to determine the efficacy and toxicities of moderately
      hypofractionated conformal radiation combined With S-1 for esophageal squamous cell
      carcinoma.

      All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with
      thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV. The
      primary end point is progression-free survival, which is the time that passes from the first
      day of radiotherapy to the date on which disease progresses. Progression-free survival will
      be calculated and compared using the Kaplan-Meier method.Toxicities will be graded according
      to CTCAE v. 4.0.
    

Intervention name(s): Moderately hypofractionated conformal radiation combined With S-1
Intervention type(s): Combination Product
Intervention description(s): All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal Squamous Cell Carcinoma; Hypofractionated Conformal Radiation; S-1
Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine if the addition of midostaurin (PKC412) to Standard of Care (SOC) therapy
      reduces relapse in FLT3-ITD mutated AML patients receiving an allogenetic hematopoietic stem
      cell transplant,
    


Intervention name(s): Midostaurin; Standard of Care
Intervention type(s): Drug; Other
Intervention description(s): Midostaurin was supplied in 25mg soft gelatin capsule taken orally twice a day for 28 days of each cycle. Patients will be treated for 12 cycles.; Standard of Care was not defined per protocol. The investigator prescribed based on the commonly used medications given in the post SCT setting.
Other intervention name(s): PKC412
Intervention MeSH terms: Midostaurin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: acute myeloid leukemia; AML; FLT3-ITD; midostaurin; PKC412; allogeneic hematopoeitic stem cell tranplant; SCT; HSCT; CR1; adult
Effect of Dietary Macronutrient Composition
Condition: Metabolic Syndrome; Non-alcoholic Fatty Liver Disease; Obesity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to understand why Hispanics who are overweight have a higher
      incidence of fatty liver disease.
    

Detailed description: 
      Obesity is a major factor driving the increased prevalence of hepatic steatosis in the US.
      However, little is known regarding the relationship between dietary intake and hepatic fat
      deposition or about the factors that promote loss of hepatic steatosis. Here, the
      investigators will determine how differences in dietary composition affect the development
      and regression of fatty liver. The investigators hypothesize that Hispanic subjects with
      metabolic syndrome will have higher liver fat synthesis rates compared to African American
      subjects.

      Using detailed in vivo, serial measurements of fuel metabolism (GC/MS and NMR) fatty acid
      metabolism will be measured in the liver and periphery. This will be the first study in which
      these two methodologies are used together to assess both glucose and fatty acid metabolism in
      the same subjects. Subjects will be tested before and after a dietary weight-loss
      intervention producing 6% body weight loss over 5 months.

      The specific aims are as follows:

      AIM 1: Determine the contribution of peripheral and dietary fat to liver-TG in Hispanics and
      African Americans with metabolic syndrome.

      Hypothesis: De novo lipogenesis will contribute to liver-TG in greater quantities compared to
      African Americans.

      AIM 2: Determine the effects of low-CHO and low-fat diets on liver fat regression.

      Hypothesis: Compared to a low-fat diet, a low-CHO diet will markedly decrease markers of
      inflammation coincident with greater improvements in insulin sensitivity as assessed by an
      intravenous glucose tolerance test.
    

Intervention name(s): Low-fat diet; Low-carbohydrate diet
Intervention type(s): Other; Other
Intervention description(s): The subject will consume a diet that is calorically restricted to cause at least a 6% body weight loss over 4 months. Fat will make up less than 30% of dietary energy.; The diet will be restricted in energy to cause at least a 6% loss of body weight over a 4 month period. Carbohydrate will provide less than 40% of total dietary energy.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Metabolic syndrome; Non-alcoholic fatty liver disease; Obesity Metabolism; Stable isotopes; Dietary weight loss
Effects of Training in a Virtual Environment in Healthy Elderly
Condition: Elderly
Study type: Interventional

Summary: 
      The objective of this work was to compare the effects of two balance training programs, one
      Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,
      on the (1) balance, (2) gait, (3) functionality and (4) cognition ability in older adults. It
      is a prospective, single blinded, randomized clinical trial performed at Center of Research
      of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo
      University. Thirty-two older adults are randomly in control and experimental group, 16 each
      one. The study includes only participants scoring at least 24 in the Mini-Mental State
      Examination to rule out effects of dementia; without the presence of depression, according to
      the Geriatric Depression Scale of Yesaváge - version 15 (GDS-15 ≤ 5) and scores on the Berg
      Balance Scale (EBB ≥ 41).
    

Detailed description: 
      The objective of this work is to compare the effects of two balance training programs, one
      Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system,
      on balance, gait, functionality and cognition ability in older adults. It is a prospective,
      single blinded, randomized clinical trial performed at Center of Research of the courses of
      Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Thirty-two
      older adults are randomly in control and experimental group, 16 each one. Both groups
      performed 14 training sessions, twice a week, for seven weeks. Each session is composed of a
      30 minute-global-exercise series including stretching, muscle strength and axial mobility
      exercises. After this, both groups performed more 30 minutes of balance training: the control
      group performed balance exercises without external cues, visual or auditory feedbacks or
      cognitive stimulations; the experimental group performed the balance training with 10 Wii Fit
      games which stimulated motor and cognitive functions. The main outcome measures are: (1)
      Mini-BESTest of Dynamic Balance Evaluation; (2) Dynamic Gait Index (DGI); (3) Montreal
      Cognitive Assessment (MoCA); and (4) Falls Efficacy Scale - International (FES-I).
    

Intervention name(s): Virtual Reality Training; Physical Therapy
Intervention type(s): Device; Other
Intervention description(s): The participants of the study trained 10 balance games during 14 sessions; Patients of the control group was trained with balance exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Control posture; Gait; Virtual Reality; Elderly
Single-dose Study of [14C]PF-05221304 Metabolism and Excretion in Healthy Adult Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to characterize the absorption, distribution, metabolism, and
      excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects
    


Intervention name(s): [14C]PF-05221304
Intervention type(s): Drug
Intervention description(s): a single oral dose of [14C]PF-05221304 (50 mg/100 µCi liquid formulation)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of the Interaction of Tunodafil Hydrochloride Tablets and Alcohol
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is primarily to evaluate the effects of simultaneous administration
      of Tunodafil Hydrochloride Tablets with alcohol on blood pressure, pulse rate and
      pharmacokinetics in healthy Chinese male participants.
    

Detailed description: 
      This study will be divided into two parts: pre-trial and formal trial. The pre-trial is a
      non-randomized, open design to evaluate the safety and tolerability of Tunodafil
      Hydrochloride Tablets in combination with alcohol in healthy male participants. Four
      participants will be taken 50mg or 100mg doses with alcohol. Supine blood pressure (systolic
      and diastolic), pulse rate, PK blood sample collection should be performed before and after
      administration, and the time point is the same as the formal trial.

      The dosage of Tunodafil Hydrochloride Tablets in the formal trial will be determined based on
      the pre-trial results.

      The formal trial is a single-center, randomized, blind, placebo-controlled, three-cycle
      crossover design, and 18 participants will be randomized to receive the following three
      treatments. The test is administered once per cycle and the washout period is 7 days:

      Treatment A: A single oral dose of Tunodafil Hydrochloride Tablets plus an oral dose of
      alcohol drink mixed with fruit juice (0.5 g of absolute ethanol per kilogram of body weight).

      Treatment B: A single oral dose of placebo plus an oral dose of alcohol drink mixed with
      fruit juice (0.5 g of absolute ethanol per kilogram of body weight).

      Treatment C: A single oral dose of Tunodafil Hydrochloride Tablets plus an oral dose of
      placebo drink mixed with fruit juice.

      For each treatment period, supine blood pressure and pulse rate will be measured at pre-dose
      and up to 24 hours post-dose. Blood will be collected at pre-dose and up to 24 hours
      post-dose.
    

Intervention name(s): Tunodafil Hydrochloride Tablets; Placebo; Alcohol
Intervention type(s): Drug; Drug; Other
Intervention description(s): 100mg Tunodafil Hydrochloride Tablets; Placebo; 0.5 g/kg alcohol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment