bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Repaglinide and Metformin Combination Tablet Versus Repaglinide and Metformin as Separate Tablets in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Asia. The aim of this clinical trial is to investigate the
      bioequivalence of repaglinide and metformin combination tablet versus repaglinide and
      metformin as coadministered tablets after meal.

      The trial is designed as a three-period, six-sequence, single-dose, crossover pharmacokinetic
      trial where the trial participant is randomised to one of six possible treatment periods
      (Williams design). The trial participant will receive one single dose of each trial product
      in varying order.
    


Intervention name(s): repaglinide and metformin combination tablet; repaglinide and metformin combination tablet; repaglinide; metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Combination tablet of repaglinide (1.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast; Combination tablet of repaglinide (2.0 mg)/metformin (500 mg) given just prior to a standard normal breakfast; Co-administration of metformin 500 mg tablet and repaglinide 2 mg tablet given just prior to a standard normal breakfast; Concomitant administration: Metformin 500 mg tablet and Repaglinide 2 mg tablet
Intervention MeSH terms: Metformin; Repaglinide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The CX-DZ-Ⅱ Intelligent Electroacupuncture Instrument for Neck Pain
Condition: Acupuncture; Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The present study is a prospective, two-center, randomized, controlled, open-label,
      non-inferiority trial evaluating the efficacy and safety of a new intelligent
      electroacupuncture instrument in treating neck pain caused by cervical spondylosis.
    

Detailed description: 
      A total of 160 eligible patients will be included in this trial and randomly assigned to
      experimental group and control group in a 1:1 ratio. In experimental group, selected
      acupoints will be stimulated by the new intelligent electro-acupuncture instrument; while for
      control group, electroacupuncture treatment will be accomplished by a pre-existing
      electro-acupuncture instrument. The duration of treatment will be 2 weeks. The primary
      outcome is the change of visual analog scale score after one course of treatment. The
      secondary outcomes are visual analog scale score after each treatment, the responder rate,
      drug-usage rate of non-steroidal antipyretic analgesics, the occurrence rate of adverse
      events, defect rate of instrument, and excellent rate of instrument.
    

Intervention name(s): intelligent electroacupuncture instrument; Hwato electroacupuncture instrument
Intervention type(s): Device; Device
Intervention description(s): Choice of major points: GB20, GB21, EX-B2, GV14. Choice of adjunct points based on syndrome differentiation.
Trial instrument of this study is the CX-DZ-Ⅱ type intelligent electroacupuncture therapeutic instrument.Choice of acupuncture needle: one-off stainless acupuncture needle, which is 25~40mm in length and 0.30~0,38mm in diameter.Waveform: continuous-wave with frequency of 120~250 times per minute and current intensity within patients' tolerance.Treatment time: each treatment time is 30 minutes.; Choice of major points: GB20, GB21, EX-B2, GV14. Choice of adjunct points based on syndrome differentiation.
The Hwato electroacupuncture treatment instrument. Waveform: continuous-wave with frequency of 120~250 times per minute and current intensity within patients' tolerance.
Treatment time: each treatment time is 30 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: electroacupuncture instrument
The Use of Magnetic Brain Stimulation to Treat Obsessive Compulsive Disorder, a Pilot Study
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is two-fold: first, to observe the effect of one session of
      repetitive transcranial magnetic stimulation (rTMS) on the error-prediction abilities of
      patients with obsessive compulsive disorder (OCD) as well as healthy individuals; and second,
      to observe the clinical effect of 10 sessions of rTMS in patients with OCD.
    

Detailed description: 
      A battery of cognitive tasks designed to selectively measure several aspects of anterior
      cingulate cortex (ACC) function, will be administered before and after one session of rTMS in
      all participants. The first neurocognitive session will be administered in a separate day
      from the rTMS session. The second neurocognitive session will be performed immediately after
      rTMS and in the same day. Participants will perform five tasks designed to test: error
      processing, error likelihood assessment, meta-memory, response inhibition, and affect
      recognition.

      The rTMS paradigm will consist of four short trains of magnetic pulses which include 5
      minutes of stimulation with 1Hz frequency (overall 1200 pulses in one session) with an
      intensity of 110% of each participant's motor threshold, and 2 minute intervals between the
      stimulation trains. Stimulation will be applied over the dorsal ACC (dACC) using a
      double-cone rTMS coil. dACC will be precisely targeted using neuronavigation software loaded
      a high resolution MRI of each subjects' brain.

      OCD patients will go on to receive two weeks (10 sessions) of daily rTMS treatments using the
      same protocol described above.
    

Intervention name(s): Transcranial Magnetic Stimulation
Intervention type(s): Device
Intervention description(s): A non-invasive method for brain stimulation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obsessive-Compulsive Disorder; Transcranial Magnetic Stimulation; Error processing
Predictors of Exposure Success in Public Speaking Anxiety
Condition: Performance Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      Anxiety disorders are common and impairing. Although exposure therapy is one of the most
      effective treatments for anxiety, some individuals do not fully respond to treatment, and
      these individual differences are not well understood. Exposure therapy involves repeated,
      deliberate, safe engagement with a feared stimulus without the feared outcome occurring. This
      treatment is thought to work through a type of emotional learning called fear extinction.
      This study aims to look at links between fear extinction learning and exposure success, with
      the overall goal of better understanding who is likely to respond best to exposure therapy
      and why.
    


Intervention name(s): Massed speech exposure session
Intervention type(s): Behavioral
Intervention description(s): One session consisting of 4 speech exposures, each 5 minutes long.
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
A Study to Investigate the Effect of Protein in Infant Formula on Insulin Response in Adults
Condition: To Compare the Metabolic Effects of Different Infant Milks
Study type: Interventional

Summary: 
      It has been established that the consumption of a diet that causes a low rise in blood
      insulin levels is beneficial in terms of risk for diabetes and heart disease. Furthermore, it
      is known that certain nutrients contained within a food play an important role in the insulin
      response of that food. For example, the type and quantity of protein has been shown to affect
      the insulin response to particular foods.

      Different types of infant formula exist, containing different levels and types of protein,
      yet the impact of these different infant formulas on blood insulin levels is not known.

      Using a randomized, double blind, cross-over study design, the insulin response to four test
      milks was compared in healthy adults. The four test milks were as follows: i) infant formula
      containing partially hydrolyzed protein; ii) infant formula with intact protein; (iii) infant
      formula with a higher energy and protein content compared to (i) and (ii); and (iv) human
      breast milk (in a small sub-group). The aim of the study was to show that the insulin
      response to the partially hydrolyzed formula is similar to that of an infant formula with
      intact protein.
    


Intervention name(s): Intact formula; Partially hydrolyzed formula; High protein formula; Human breast milk
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 600 ml of infant formula with intact protein; 600 ml of infant formula with partially hydrolyzed protein; 600 ml of infant formula with high protein level; 600 ml of breast milk, safe for human consumption
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: infant formula; intact protein; partially-hydrolyzed protein; glucose; insulin; metabolic response
Doppler and Biological Second Trimester Placental Insufficiency Screening
Condition: Pre-Eclampsia; Fetal Growth Retardation; Placental Insufficiency
MeSH terms: Eclampsia; Pre-Eclampsia; Fetal Growth Retardation; Placental Insufficiency
Study type: Observational

Summary: 
      To assess the role of uterine artery and maternal serum leptin and lipids and their
      combination in screening for pre-eclampsia and small-for-gestational-age (SGA) fetuses at
      20-24 weeks of gestation
    

Detailed description: 
      Pre-eclampsia (PE) and intrauterine growth restriction (IUGR) are known as major factors in
      perinatal morbidity and mortality. Routine antenatal care is focused on the detection of
      women at increased risk to apply this population a program of careful monitoring and
      appropriate intervention.

      Uterine artery Doppler during anomaly scan at 20 to 24 weeks in selected women at increased
      risk, has proved to be accurate to detect those who will develop PE or IUGR during the second
      half of pregnancy. Studies have reported detection rate of 50-70% for a 5% false positive
      rate in women developing early pre-eclampsia.

      A variety of proteins and hormones have been studied as potential markers for pre-eclampsia.
      Among these protein serum placental leptin has demonstrated higher levels in pregnant women
      who will subsequently develop pre-eclampsia. However, screening performance of leptin
      detection in early pregnancy has never been assessed.

      Our study is aimed to evaluate the performance of serum leptin measurement in association
      with uterine artery Doppler as a screening too for placental insufficiency.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women at increased risk of pre-eclampsia (PE) and intrauterine growth restriction (IUGR)
      
Keywords: Screening; uterine artery Doppler; HELLP syndrome; abruption
Ice Popsicle for Thirst Relief of the Surgical Patient
Condition: Thirst
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of ice popsicle compared with water at
      room temperature in relieving thirst in the immediate postoperative period . The hypothesis
      of the study is that ice has 20% greater efficacy than water to relieve thirst in the
      immediate postoperative period.
    

Detailed description: 
      There is evidence that ice is effective in relieving thirst in surgical patients, because, by
      stimulating the oral receptors sensitive to cold, ice decreases the need to ingest large
      volumes of liquids to satisfy thirst. This way, the risk of bronchoaspiration due to gastric
      fullness is avoided and discomfort with dry mouth is reduced. Preliminary evidence,
      therefore, indicates that the use of ice chips have greater efficacy than water at room
      temperature in relieving thirst. However, there is no scientific evidence from controlled
      studies with results that can be generalized with respect to a safe volume and adequate
      frequency of ice administered to reduce thirst in the immediate postoperative
      period.Considering that the gold standard for the study of a symptom is based on individuals'
      perceptions and their reports, this study is justified in order to assess the effectiveness
      of ice compared with water at room temperature in relieving thirst in the immediate
      postoperative period.
    

Intervention name(s): Ice popsicle; Water at room temperature
Intervention type(s): Other; Other
Intervention description(s): Patients were assessed according to the following criteria before each intervention: level of awareness; airway protection capacity; and absence of nausea and vomiting, according to the Safety Protocol for Thirst Management. The experimental group received an ice popsicle made of 10 mL mineral water.
The ice popsicles were made according to the predetermined volumes and packed in the freezer of the anesthetic recovery room at the institution researched. The block of ice were supported by a stick, allowing the patients to control the intensity of cold conferred by the ice for their comfort.; Patients were assessed according to the following criteria before each intervention: level of awareness; airway protection capacity; and absence of nausea and vomiting, according to the Safety Protocol for Thirst Management. The usual activities adopted by the nursing staff of the anesthetic recovery room were maintained for the control group that received 10 mL mineral water at room temperature in a syringe.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thirst; Ice; Water; Perioperative Nursing; Recovery Room
Deep Brain Stimulation in Treating Patients With Dystonia
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      RATIONALE: Dystonia is a disorder in which the muscles that control voluntary movements are
      persistently or intermittently contracted (not relaxed). Deep brain stimulation is provided
      by a small, battery operated implant placed under the skin of the chest that delivers low
      voltage electrical pulses through a wire under the skin that is connected to a specific area
      of the brain. Deep brain stimulation may help lessen the symptoms of dystonia.

      PURPOSE: Phase II/III trial to study the effectiveness of deep brain stimulation in treating
      patients who have dystonia.
    

Detailed description: 
      PROTOCOL OUTLINE: Patients undergo surgery to implant a brain stimulation system consisting
      of an implanted pulse generator (IPG) in the chest and a wire lead in the globus pallidum
      internal. After the lead has been implanted, the brain stimulation system is tested. Patients
      are examined at 1, 3, 6, 9, and 12 months after surgery. A double blinded evaluation, during
      which the IPG is either off or on, is carried out at 3 and 6 months.

      Patients are followed every 3 months as long as the brain stimulation system remains in
      place.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): implanted pulse generator
Intervention type(s): Device
Primary purpose: Treatment
Keywords: dystonia; neurologic and psychiatric disorders; rare disease
Armolipid Plus and Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Metabolic syndrome is a highly prevalent condition characterized by visceral obesity,
      abnormalities of glucidic and lipid metabolism, and increased risk for cardiovascular events.
      Such findings appear to be associated with a decrease in insulin sensitivity. Management of
      metabolic syndrome is currently aimed at treating individual components of the disease
      without addressing this underlying pathophysiologic mechanism; this translates into multidrug
      regimens, high costs and patient compliance issues.

      Armolipid Plus (an association of berberine 500 mg, red yeast rice titled in 3 mg monacolin
      K,policosanol 10 mg,coenzyme Q10 2 mg,astaxanthin 0,5 mg,folic acid 0,2 mg) has been found to
      be effective at reducing blood cholesterol and triglycerides, and at improving endothelial
      function; subgroup analyses also suggested a benefit on indices of insulin resistance.

      Aim of the study is to evaluate the effects of Armolipid Plus on insulin sensitivity and on
      the diagnostic parameters of metabolic syndrome.

      60 patients will be enrolled in this randomized, double-blind, placebo-controlled trial;
      active treatment will consist of Armolipid Plus (1 tbl qd).

      Primary end point will be the reduction of the insulin/glucose ratio, both after overnight
      fast (HOMA index) and after an oral glucose tolerance test (OGTT).
    


Intervention name(s): Armolipid Plus
Intervention type(s): Dietary Supplement
Intervention description(s): Armolipid Plus 1 tablet QD for 18 weeks
Other intervention name(s): berberine; red yeast rice; monacolin K; policosanol; coenzyme Q10; astaxanthin; folic acid
Intervention MeSH terms: Folic Acid; Coenzyme Q10; Policosanol; Red yeast rice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metabolic Syndrome Insulin-resistance Endothelial Function
Assessing the Effects of Omega-3 Supplementation on Serum HSP27, HSP70, YKL40, BMP-4 Levels in Male Patient With CAD
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is the comparison between the effects of supplementation with omega 3
      or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with
      cardiovascular disease.
    

Detailed description: 
      The aim of this study is the comparison between the effects of supplementation with omega 3
      or placebo for 8 weeks in serum level of BMP-4, YKL40, HSP70, HSP27 in patients with
      cardiovascular disease. In this randomized, double-blind clinical trial, placebo-controlled,
      single-center, and phase two trials, 42men aged 45-65 years with Coronary Artery Disease are
      enrolled in the study from Tehran Heart Center. After signing informed consent all
      individuals complete a general information form , 24-hour food recall for 3 days will be
      taken from the participants at the beginning and the end of the study,. Selected samples are
      randomly classified into 2 blocks of groups receiving supplement and placebo. The supplement
      group, will receive 4 g/day omega 3 fatty acid for 8 weeks and the placebo group will also
      receive placebo (containing 4 g of edible paraffin) (similar in terms of color, shape and
      size). Patients are recommended to sustain their diets and medication dose (s) during the
      study and also advised to maintain a constant level of physical activity. Blood samples will
      be collected after 8-12 hours fasting and anthropometric variables, biochemical parameters
      and physical activity before and after the trial will be measured.
    

Intervention name(s): Omega-3; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4 cap 1 g Omega-3 per day for 2 months; 4 cap 1 g Placebo(paraffin) per day for 2 months
Other intervention name(s): n-3 fatty acids; n-3 PUFA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atherosclerotic; BMP-4; YKL40; HSP70; HSP27
Comparing Newly Developed PreCore Needle With Conventional Fine Needle in Suspected Unresectable Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      Background:

      Pancreatic cancer is associated with a poor prognosis. Therefore, rapid and accurate
      diagnosis of a pancreatic mass is important to direct patient management. Endoscopic
      ultrasonography-guided fine needle aspiration (EUS-FNA) is the current standard for sampling
      pancreatic mass lesions, with diagnostic accuracy of 78% to 95%. But, the EUS-FNA has some
      limitations include stromal cell tumors and lymphomas may be difficult to diagnose. To
      overcome these limitations, a new needle device with ProCore reverse-bevel technology was
      developed recently.

      Aims:

      The objective of this prospective study is to compare the rate of diagnostic sufficiency in
      the EUS sampling by using newly developed ProCore needle with conventional FNA needle in
      suspected unresectable pancreatic cancer. We will also compare the safety, the yield of
      histologic core tissue and the cost-effectiveness between these modalities.
    

Detailed description: 
      Patient:

      Newly diagnosed pancreatic cancer patient whose cancer lesion is suspected unresectable in
      diagnostic imaging such as CT or MRI

      Procedure:

      Each EUS-guided FNA and ProCore aspiration will performed twice in same patient. The priority
      of order will be given by randomization assignment.

      The number of patients required:

      Total sixty five patients will be required.
    

Intervention name(s): 22 gauge ProCore needle aspiration; 22 gauge Fine needle aspiration
Intervention type(s): Device; Device
Intervention description(s): Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration; Pancreatic mass evaluation through the 22 gauge Fine needle aspiration
Other intervention name(s): EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle; 22 gauge, EN-SHOT2 Side Port Aspiration Needle
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Nutritional Supplements & Complementary/Alternative Medicine by Prostate & Breast Cancer Patients
Condition: Prostate Cancer; Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study was a survey to determine the frequency of Complementary and Alternative Medicine
      (CAM) use in patients recently diagnosed with breast or prostate cancer who were starting
      radiation therapy. The survey was repeated at three time points to assess changes in CAM use
      over time.
    


Intervention name(s): questionnaire administration
Intervention type(s): Other
Intervention description(s): Ancillary studies
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Men with clinically localized prostate cancer that have chosen external beam irradiation or
        brachytherapy or a combination for their treatment and women with localized breast cancer
        who are scheduled to begin external beam radiation therapy as a component of their primary
        or adjuvant therapy.
      
Keywords: CAM; Alternative Medicine