bioihbjkbjnl/mcl2 huggingface dataset:
Community Approach to Reduce the Risks of Diabetes After Gestational Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      Objective: The current study examined the effectiveness of a culturally-appropriate
      adaptation of the diabetes prevention program (DPP) curriculum in reducing type 2 diabetes
      risk in Latinas with a history of gestational diabetes mellitus (GDM).

      Research Design and Methods: Seventy-six Latinas aged 18-45 years with GDM in the past 3
      years participated in an 8-week group-based, peer-educator led lifestyle intervention based
      on the DPP, with adaptations appropriate to Latino culture and recent mothers. Clinical and
      self-report indicators were assessed at baseline, post-intervention (month-3), and follow-up
      (month-6).

      Hypothesis-The modified culturally tailored DPP will improve risk factors associated with the
      development of type 2 DM.
    


Intervention name(s): Dulce Mother lifestyle training program
Intervention type(s): Behavioral
Intervention description(s): 12 once weekly culturally tailored lifestyle management sessions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Latinas; Gestational Diabetes; Prevention
Clinical Research Study to Evaluate the Stain Removal Efficacy
Condition: Tooth Stain Removal
MeSH terms: Tooth Discoloration
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical research study is to evaluate the stain removal efficacy of a
      toothpaste containing stannous fluoride as compared to negative control toothpaste in adults.
    


Intervention name(s): Stannous Fluoride Toothpaste (SnF); Colgate Fluoride Toothpaste (CDC)
Intervention type(s): Drug; Drug
Intervention description(s): test; negative control
Intervention MeSH terms: Fluorides; Tin Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Composite Lobene; extrinsic stain
Study to Assess Pharmacokinetics, Safety and Tolerability of PF-04965842 in Chinese Healthy Participants
Condition: HEALTHY
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics, safety and tolerability of
      PF-04965842 after single dose and once-daily multiple-doses in Chinese healthy participants.
    

Detailed description: 
      This is a Phase 1, open-label, single-arm, single- and multiple-dose study to assess the
      pharmacokinetics, safety and tolerability of PF-04965842 in Chinese healthy participants.
    

Intervention name(s): PF-04965842
Intervention type(s): Drug
Intervention description(s): For this study, the investigational product is PF-04965842 (provided as 100 mg tablet).
PF-04965842 100 mg tablets will be provided by Pfizer. Investigational product will be presented to the participants in individual dosing containers
Other intervention name(s): Following an overnight fast for at least 10 hours, participants will receive PF-04965842 oral single dose of 200 mg (2 × 100 mg tablets) on Day 1, at approximately 08:00 am plus or; minus 2 hours in the morning, and repeated doses on Day 3 to 8. On Day 8, the dosing will be under fasted; condition at approximately 8:00 am plus or minus 2 hours in the morning.
Intervention MeSH terms: Abrocitinib
Intervention model: Single Group Assignment
Intervention model description: open-label, single-arm, single- and multiple-dose study
Masking: None (Open Label)
Primary purpose: Treatment
Cardiogenomics Registry
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      This is a continuous blood banking study that will archive plasma and blood permitting DNA
      and plasma analysis at a future date. Subjects are recruited at the time of a clinically
      required procedure and blood samples are collected and banked and used for future research.
      The main purpose of this study is to investigate the interaction of multiple phenotypes and
      genotypes and their impact on cardiovascular disease events and measures of atherosclerosis
      progression.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects undergoing a clinical required cardiovascular procedure
      
Biospecimen description: 
      20 mL of blood are collected and aliquots of whole blood, plasma, serum and buffy coat are
      stored.
    
Keywords: Cardiovascular
The Relation Between MiR-125b-5p and Staging of Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional

Summary: 
      78 endometriosis patients presented with infertility were clinically examined and the
      diagnosis was assured by US imaging. The study also included 11 control fertile women free of
      gynecological problems as a control for lab tests. Patients and controls gave blood samples
      for lab investigations. All patients underwent diagnostic abdominal laparoscopy under general
      anesthesia for disease staging. Quantitative determination of expression levels of genes of
      microRNA-125b-5p and 203a was conducted using qRT-PCR.
    


Intervention name(s): laparoscopic examination; Blood sampling
Intervention type(s): Procedure; Diagnostic Test
Intervention description(s): laparoscopic examination for staging of endometriosis; Blood sample to detect endometriosis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Pilot Trial of Surfactant Therapy For Preterm Neonates 5-21 Days Old With Respiratory Decompensation
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      The purpose of the study is to determine whether additional surfactant(Infasurf) doses at 7
      to 10 days of life time will improve lung function in premature infants, allowing a decrease
      in required oxygen concentration and ventilator settings.
    

Detailed description: 
      Pulmonary surfactant is required for normal lung function. Preliminary data from previous
      trials suggest that more than half of chronically ventilated premature infants, greater than
      1 week of age, have at least one episode of surfactant dysfunction, as measured in vitro,
      associated with a low surfactant protein B content. We propose to enroll premature infants
      less than 1250 gm birthweight, between days 5 and 21 of life who are intubated, mechanically
      ventilated, with a respiratory decompensation, defined as a severity score (mean airway
      pressure x FIO2) rising from a baseline of < 1.8 to > 3.5, sustained for > 24 hours. Infants
      will receive two doses of Infasurf surfactant, 12-24 hours apart, at the standard dose of 3
      ml/kg. Primary outcome is the change in respiratory severity score at 72 hours post
      surfactant treatment compared to pre-treatment. Sample size is 31 infants, study duration is
      3 years, and recruitment of study patients will occur at the Hospital of the University of
      Pennsylvania, and Women and Children's Hospital of Buffalo.
    

Intervention name(s): Infasurf (drug)
Intervention type(s): Drug
Intervention description(s): Infasurf 3 cc/kg instilled via endotracheal tube q 12-24 hours x 2 doses
Other intervention name(s): Infasurf (calfactant, manufactured for Forest Pharmaceuticals, Inc. St. Louis, MO, by ONY Inc., Amherst, NY
Intervention MeSH terms: Calfactant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prematurity; Lung Disease; Hyaline Membrane; Surfactant
A Study of RO4917838 (Bitopertin) in Patients With Acute Exacerbation of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized, double-blind, placebo- and active-controlled, parallel group study will
      evaluate the safety and efficacy of RO4917838 (bitopertin) in patients with acute
      exacerbation of schizophrenia. Patients will be randomized to receive either RO4917838 10 mg
      or RO4917838 30 mg or olanzapine 15 mg or placebo orally daily for 4 weeks as inpatients,
      with a 4-week follow-up period.
    


Intervention name(s): bitopertin [RO4917838]; bitopertin [RO4917838]; olanzapine; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10 mg orally daily, 4 weeks; 30 mg orally daily, 4 weeks; 15 mg orally daily, 4 weeks; orally daily, 4 weeks
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)
Condition: Facial Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      To evaluate the effect of the Ulthera® system for facial laxity and sagging skin
    


Intervention name(s): Microfocused ultrasound with visualization
Intervention type(s): Device
Intervention description(s): Each subject to receive a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5mm and 7-3.0mm transducer depths
Other intervention name(s): Ultherapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Reflux Esophagitis
Condition: Reflux Esophagitis
MeSH terms: Gastroesophageal Reflux; Esophagitis; Esophagitis, Peptic
Study type: Interventional

Summary: 
      Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the
      patients reflux esophagitis.

      Methods: We accrued 29 patients at Beijing TongRen Hospital Affiliated to Capital Medicine
      University of. All treatments were self-administered by the patients at home after training
      at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12
      weeks and 24 weeks. Endoscopy, reflux diagnostic questionnaire (RDQ), gastrointestinal
      symptom rating scale (GSRS), and SF-36 were performed to evaluate the therapeutic effects. A
      difference of P < 0.05 was considered statistically significant.
    


Intervention name(s): Transcutaneous Auricular Vagus Nerve Stimulation
Intervention type(s): Device
Intervention description(s): to use taVNS to treat Reflux Esophagitis
Intervention model: Single Group Assignment
Intervention model description: Transcutaneous Auricular Vagus Nerve Stimulation
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Reflux esophagitis; Transcutaneous auricular vagus nerve stimulation; Gastroesophageal reflux disease
Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome
Condition: Postural Orthostatic Tachycardia Syndrome
MeSH terms: Postural Orthostatic Tachycardia Syndrome; Tachycardia; Syndrome
Study type: Interventional

Summary: 
      Postural orthostatic tachycardia (POTS) is characterized by abnormalities in the autonomic
      nervous system in the body. The autonomic nervous system controls and regulates body
      functions such as heart rate, breathing, digestion, and more.

      The investigator has shown that patients with POTS have higher cardiovascular and adrenergic
      activating autoantibodies (AAb), which likely changes the normal make-up of POTS. There are
      autoantibodies that have been suggested by a few reports of their presence in POTS, but their
      role different aspects of POTS is unknown. The study will look at the body's responses in
      patients with POTS. The crossover study design is to have half of the patients will start
      with sham followed by active stimulation and half will start by active followed by sham
      stimulation. It is anticipated that results will provide a potential therapeutic approach
      based on the understanding of POTS.
    


Intervention name(s): Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device
Intervention type(s): Device
Intervention description(s): Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparative Clinical Trial of Efficacy and Safety of Ergoferon Versus Oseltamivir in Treatment of Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is:

        -  to assess the efficacy of Ergoferon in treatment of influenza;

        -  to assess the safety of Ergoferon in treatment of influenza;

        -  to compare the efficacy of Ergoferon and Oseltamivir for treatment of influenza.
    

Detailed description: 
      The overall duration of a patient participation in the trial is 6 days
      (screening/randomization/therapy onset - day 1; study therapy period - day 1-5; follow-up
      period - day 6).
    

Intervention name(s): Ergoferon; Oseltamivir
Intervention type(s): Drug; Drug
Intervention description(s): Safety and Efficacy; Safety and Efficacy
Other intervention name(s): Tamiflu
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-invasive Brain Stimulation for Gait Improvement in Patients With Spinal Cord Injury
Condition: Functional Improvement
Study type: Interventional
Phase: Phase 3

Summary: 
      to optimize the functional outcome in early phase of gait rehabilitation in subacute
      incomplete SCI patients using rTMS as an additional treatment to physical therapy (e.g. to
      gait training in Lokomat®). Using this add-on therapeutic strategy, we expected larger
      improvement of gait function than with physical therapy alone.
    

Detailed description: 
      Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive and painless procedure
      to modulate cortical excitability of motor areas and induce changes over the descending
      corticospinal output. This modulation may be useful to promote active recovery of motor
      function and to obtain functional benefit from gait rehabilitation. Through the use of
      repetitive high-frequency rTMS, improvement has been reported in motor and sensory functions
      measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS), and time
      to complete a peg-board task in four chronic incomplete cervical SCI patients.

      Physical therapy aims to improve function of both undamaged and also, as far as possible,
      damaged neuronal structures. However, 'reorganization' of neuronal circuits is the target of
      specific training approaches. Therefore, the challenge is to guide CNS plasticity in order to
      optimize the functional outcome for a given individual. Hypothesized was that high-frequency
      rTMS coupled with gait training can improve motor recovery in the lower extremities and
      locomotion in incomplete SCI patients to a greater degree than sham stimulation.
    

Intervention name(s): rTMS; sham rTMS
Intervention type(s): Device; Device
Intervention description(s): For real (active) rTMS, we applied 2 seconds duration bursts of 20 Hz (40 pulses/burst) with intertrain intervals of 28 seconds, for a total of 1800 pulses over 20 minutes; Sham Comparator: sham rTMS (SHAM GROUP)
For sham rTMS, the double cone coil was again held over the vertex, but it was disconnected from the main stimulator unit. Instead, a second coil (8-shaped) was connected to the MagStim stimulator, and discharged under the patient's pillow (2).
Other intervention name(s): active rTMS; active group; real rTMS; sham group; placebo group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Crossover Study Assessing the Pharmacokinetics, Pharmacodynamics, and Safety of Recombinant Human Insulin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, and safety of
      recombinant human insulin. The study will consist of 2 phases.
    


Intervention name(s): Insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Human Volunteers
Ring-type Pulse Oximeter for Evaluation for Sleep Assessment Study
Condition: Sleep-Disordered Breathing; Sleep Architecture
MeSH terms: Sleep Apnea Syndromes
Study type: Interventional

Summary: 
      Recently, various electronic lifestyle activity monitoring devices (ELAM) are increasingly
      commercially available. However, the quality and reliability of the data from ELAM are
      unclear, compared with polysomnography (PSG), which is the gold-standard sleep assessment
      method. Thus, combining ELAM with PSG will validate ELAM and improve its clinical and
      research utilization.

      The investigators propose to conduct this study to validate ELAM device for sleep assessment.
      The investigators will compare Belun Ring data collection and overnight in-lab PSG measures
      of Sleep-Disordered Breathing (SDB) and sleep architecture in adults with obstructive sleep
      apnea (OSA) symptoms.

      The investigators propose to recruit a total of 40 participants with symptoms of OSA. The
      overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep
      architecture will be validated by using PSG analysis as a gold standard.
    


Intervention name(s): Belun Ring Pulse Oximeter
Intervention type(s): Device
Intervention description(s): Belun Ring Pulse Oximeter allows measurement and analysis of oximetry, pulse rate, photo-plethysmography (PPG), and accelerometer signals from the proximal phalanx of index finger. Sleep stage (bSTAGES) and respiratory event index (bAHI) are estimated.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of Herbs and Spices on Metabolic Regulation and Appetite in Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the study is to investigate how herbs and spices affect acute/postprandial
      glucose and insulin responses, inflammatory markers, appetite control peptides, antioxidative
      capacity, as well as subjective appetite ratings (VAS-visual analogue scales) in healthy
      volunteers. We hypothesize that certain herbs and spices added to a standardized meal will
      improve postprandial glucose tolerance and other metabolic biomarkers in healthy volunteers,
      compared with a similar meal without the corresponding plant materials.
    

Detailed description: 
      The aims of the study is to investigate whether consumption of preload isovolumetric (220 ml)
      spice-based beverages contained total polyphenol concentration to 185 mg gallic-acid
      equivalents followed by white wheat bread challenge (contained 50 g available carbohydrate)
      might affect postprandial glucose metabolism, inflammatory markers, appetite-related gut
      hormones, plasma antioxidant capacity, as well as appetite sensations in healthy subjects.
    

Intervention name(s): Spices 1; Spices 2; Spices 3; Herbs 1; Herbs 2; Control drink
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 1. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.; In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 2. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.; In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 3. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.; In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of herbs 1. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.; In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of herbs 2. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.; As a control, subjects are asked to consume 200 ml control drinks. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Spices; Herbs; Functional food; Cardiometabolic risk; Metabolic syndrome; Inflammation; Appetite; Gut hormone
Insulin Sensitivity and Beta Cell Function After Carbohydrate Loading in Hip Replacement Surgery
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether preload of carbohydrate or water before
      elective hip replacement improve insulin sensitivity and or beta cell function in human.
    


Intervention name(s): Experimental: PreOp, NutriciaNordica AB; Placebo Comparator: Water
Intervention type(s): Dietary Supplement; Dietary Supplement
Other intervention name(s): PreOp, serial number 27 62 95, NutriciaNordica AB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Insulin sensitivity; Beta cell function; Carbohydrate preload; Elective hip replacement; Double-blind randomized control study
An Exploratory Study of LPM3480392 at Different Infusion Rates in Chinese Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated the safety, tolerability and PK/PD characteristics of LPM3480392
      injection by intravenous infusion at different rates in healthy subjects.The experiment was
      divided into Part A and Part B.

      Part A is a open label ,three cycle , fixed sequence dosing study .Twelve healthy male
      subjects were planned to be enrolled, and the same dose (X1mg)of LPM3480392 injection was
      intravenously injected at different infusion times in different drug administration cycles.

      Part B is an open label ,two cycle , fixed sequence dosing study .Ten healthy male subjects
      (subjects not enrolled in Part A) were given LPM3480392 injection in 2 minutes , each subject
      was given X2mg at the first cycle and X3mg at the second cycle .
    


Intervention name(s): LPM3480392
Intervention type(s): Drug
Intervention description(s): Intravenous infusion
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment