bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Cyproterone Compound-spironolactone, Metformin and Pioglitazone on Inflammatory Markers in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study is to evaluate the effects of three-month course of treatment
      modalities (Cyproterone compound-Spironolactone, Metformin and Pioglitazone) in patients with
      polycystic ovary syndrome (PCOS) on markers of inflammation [serum complement, homocysteine
      and high sensitive C-reactive protein (hs-CRP)] levels.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is estimated to affect up to10% of women of reproductive
      age, making it one of the most common endocrine disorders in this population. PCOS is
      associated with a broad range of adverse sequel, including hypertension, dyslipidemia,
      insulin resistance, hyperandrogenaemia, gestational and type 2 diabetes,which ultimately
      increase the cardiovascular morbidity in these patients. Also PCOS is increasingly recognized
      as a component of the metabolic syndrome. Management depends on symptoms or the source of
      androgen excess. Several treatment options are available, which allows for an individualized
      approach. Spironolactone is the safest potent available antiandrogen. It is effective in
      lowering the hirsutism score by approximately one third, although considerable individual
      variations exist. Other antiandrogens used to treat hirsutism and hirsutism equivalents
      include cyproterone acetate that has weak antiglucocorticoid effects. Metformin and
      thiazolidinediones, are promising adjuncts for treating PCOS. Although both of them increase
      insulin sensitivity, but their mechanism of action differ.

      Serum complement, homocysteine and C-reactive protein (CRP) levels have been reported to be
      linked with insulin resistance.

      The investigators want to measure serum complement, homocysteine and hs-CRP levels in
      patients with PCOS before and after three-month course of treatment with Cyproterone
      compound-Spironolactone (CC-S), metformin (M) and pioglitazone (P).
    

Intervention name(s): Cyproterone compound + Spironolactone; Metformin; Pioglitazone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily; Metformin 500mg three times daily; Pioglitazone 30mg once daily
Other intervention name(s): CC-S
Intervention MeSH terms: Metformin; Pioglitazone; Cyproterone Acetate; Spironolactone; Cyproterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Inflammation; Complement system proteins; Homocysteine; C-Reactive Protein; Cyproterone; Ethinyl Estradiol; Androgen Antagonists; Metformin; Thiazolidinediones; Pioglitazone
Assessment of Pulmonary Involvement inUlcerative Colitis by Induced Sputum
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      Ulcerative colitis is a systemic disease we assume that extra intestinal involvement as we
      describein our study( Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A Fireman E:
      Assessment of pulmonary involvement in Crohn's disease by induced sputum. Am J Gastroenterol
      2000;95(30):730-734. )
    

Detailed description: 
      Twenty Ulcerative colitis patients and 20 control subjects (all nonsmokers) without
      respiratory symptoms will be tested. The induce sputum by 20' inhalation of 3.5% saline using
      ultrasonic nebulizer. Samples will studied by differential counts of 200 cells on cytopreps
      stained by Giemsa. T-lymphocyte subset analyses were done by FACS using three monoclonal
      antibodies: CD3 = total T cells, CD4 = T helper cells, and CD8 = T suppressor-cytotoxic
      cells. CD4/CD8 >2.5 was considered abnormal.
    

Intervention name(s): Induced sputum (inhalation of 3.5% saline)
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Ulcerative colits; lung; Induced sputum; Our aim to evaluate lung involvement in Ulcerative colitis patients by induced sputum
Efficacy and Safety of ALT-801 in the Treatment of Obesity
Condition: Obesity/Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of ALT-801 once-weekly versus placebo as an
      adjunct to a reduced-calorie diet and increased physical activity in patients with
      obesity/overweight.
    


Intervention name(s): ALT-801; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Injected subcutaneously (SC); Injected subcutaneously (SC)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Oral Melatonin on Postoperative Analgesia After Thoracotomy in Infants
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      Thoracotomy pain is one of the severest pain that should be taken seriously, especially in
      children. (1) Inadequate postoperative pain management can compromise respiratory function,
      delay postoperative extubation, increase the cost and delay hospital discharge.

      Opioids are the most commonly used analgesics to manage postoperative pain; however, they
      have many possible unfavorable side effects, such as nausea, vomiting, pruritus, and
      respiratory depression. (3) Melatonin is an endogenous indoleamine secreted by the pineal
      gland. It has several important physiological functions, including regulation of the
      circadian rhythms, modulation of season changes, antioxidant, anti-inflammatory, and
      anticonvulsant effects. (4)
    

Detailed description: 
      The analgesic effect of melatonin may be referred to as Gi-coupled melatonin receptors, to
      Gi-coupled opioid-l-receptors or gamma-aminobutyric acid (GABA) receptors with a
      consequential reduction in anxiety and pain. (5) Gitto and co-workers(6) hypothesized that
      melatonin may have beneficial effects as an analgesic effect in preterm newborns that are
      subject to painful procedures, such as endotracheal intubation and mechanical ventilation
      without detected side effects. Pro-inflammatory and anti-inflammatory cytokines related to
      pain were more in the common sedation and analgesia group than in melatonin-treated infants
      suggesting the use of melatonin as an adjunct analgesic therapy during procedural pain. (6)
      Therefore Melatonin may be a useful perioperative drug as it does not have any known
      undesirable serious adverse effects. (7)

      To the best of investigators' knowledge, this is the first study investigating the effect of
      melatonin on postoperative pain scores after thoracotomy in infants.
    

Intervention name(s): Melatonin 3 MG Oral Tablet; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): it will be given orally one hour preoperatively; sugar-coated tablets will be given one hour preoperatively
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 50 patients will be divided into 2 equal groups
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Trial of Single Incision Versus Four Ports Laparoscopic Cholecystectomy
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Interventional

Summary: 
      Background: Single-incision laparoscopic cholecystectomy (SILC) is increasingly being used as
      a minimally invasive surgery with potential benefits over 4-port laparoscopic cholecystectomy
      (LC) in terms of postoperative pain and faster recovery.

      Methods: Seventy-three patients with symptomatic cholelithiasis were randomized to SILC
      (n=37) or LC (n=36). Data measures included operative details, adverse events, postoperative
      pain and analgesic requirements, success of the ambulatory process, return to normal activity
      and return to work, cosmetic results and quality of life score.
    


Intervention name(s): Single Incision Laparoscopic Cholecystectomy (SILC); Four Ports Laparoscopic Cholecystectomy (4PLC)
Intervention type(s): Procedure; Procedure
Intervention description(s): A 2.5-cm incision is made through the everted umbilicus down to the midline fascia, and through the fascia and the peritoneum. The multichannel port (Olympus) is introduced. Carbon dioxide is insufflated (12 mmHg) and a 30 degree 10-mm laparoscope is introduced. The operating table is put in the reverse Trendelenburg position (20 degrees), left side down. A pre-curved grasper and the monopolar electrocautery are introduced through the other 2 ports of the trocar and the dissection of the gallbladder starts in a retrograde manner. The triangle of Calot is exposed, the cystic duct and artery are separately dissected and ligated with 5 mm clips. The monopolar electrocautery is used to remove the gallbladder from the liver bed. The gallbladder is removed along with the port system from the abdominal cavity. The fascia at the port site is closed and the umbilicus is inverted.; An 11-mm periumbilical port, a 10-mm left upper quadrant port , 5mm subxyphoid port, and 5-mm right lower quadrant port were used in 4-port LC. We adopted the single surgeon technique in the 4-port LC using 30-degree operating telescopes that was inserted into the umbilical port. Retraction of the gallbladder was done by the long grasping forceps through the 5-mm right lower quadrant port, whereas dissection was accomplished through the 10-mm left upper quadrant port. The cystic duct and cystic artery were clipped by a 5-mm multiple clip applicator. The gallbladder was retrieved through the umbilical port after the position of the operating telescope was changed.
Nontransparent surgical adhesive tape was applied to the standard 4-port sites at the end of the operation .
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Clinical Study to Assess High-DHA Fish Oil on Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The objective of this study is to determine the acute and chronic [4-week] effects of a
      high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of
      cardiovascular disease risk, in adults on Statin therapy.
    

Detailed description: 
      This study involves fasted and post-prandial components.

      Fasted Study:

      Participants will provide fasting blood samples pre-and post-intervention [4-week
      administration of supplement or placebo] in Treatment Period I. Participants will again
      provide fasting blood samples pre-and post-intervention [4-week administration of supplement
      or placebo, opposite to Treatment Period I] during Treatment Period II.

      There will be a 4-week washout period during the two Treatment Periods.

      Post-prandial study:

      Participants will also complete a post-prandial study pre-and post-intervention during each
      Treatment Period.
    

Intervention name(s): Fish Oil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of fish oil [620 mg of DHA and 150 mg of EPA], providing a total daily dosage of 4000 mg of fish oil [3080 mg of DHA+EPA].; On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of olive oil, providing a total daily dosage of 4000 mg of olive oil.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Humans; Cardiovascular Disease; Statins; Fish Oil; DHA; EPA; High-DHA; Triglycerides; Total cholesterol [TC]; Lipoproteins; High-density lipoprotein [HDL2, HDL3]; Low-density lipoprotein [LDL1+2+3+4]; Lipoprotein A [Lp(a)]; Intermediate-density lipoprotein (IDL); Very low-density lipoprotein (VLDL1+2, VLDL3); Remnant Lipoproteins; High-sensitivity C-Reactive Protein [hs-CRP]; Homocysteine; Essential Fatty Acid Profile; Apolipoprotein B; Apolipoprotein A-1; Glucose; Insulin; Fasted; Post-Prandial
Drug to Drug Interaction Study With Ipragliflozin and Furosemide
Condition: Healthy Subjects; Pharmacokinetics of Ipragliflozin
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate if there are any pharmacodynamic and pharmacokinetic interactions
      between furosemide and ipragliflozin (ASP1941) in healthy volunteers.
    


Intervention name(s): Ipragliflozin; Furosemide
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): ASP1941
Intervention MeSH terms: Ipragliflozin; Furosemide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Ipragliflozin; Furosemide; Pharmacokinetics; Pharmacodynamics
Congenital Chagas Disease: Long Term Follow up of Treated Children. Preliminary Report or Cardiological Evaluation in Chagas Disease Treated Children
Condition: Chagas Disease; Chagas Cardiomyopathy
MeSH terms: Chagas Disease; Chagas Cardiomyopathy; Cardiomyopathies
Study type: Observational

Summary: 
      Chagas disease (CD) could be acquired by contact with the vector, transplacentally and by
      blood transfusion. The duration and clinical presentation of the initial acute phase of the
      infection may be variable, but the majority of patients are asymptomatic. The acute phase
      usually lasts a few months and, if untreated, the acute phase goes on to develop a chronic
      infection. The chronic phase usually continues for the subject's lifetime, and 30% to 40% of
      patients will progress to the chronic phase with a cardiac, digestive, neurological, or mixed
      form at 15 to 30 years after the initial infection. Progressive heart failure and sudden
      death due to ventricular arrhythmias are the main causes of death in patients with chronic
      Chagas heart disease.

      Objective: To evaluate cardiac involvement in children after pharmacological treatment for
      Chagas disease.

      Methods: Open exploratory study, blind for cardiological evaluation. Population: children
      treated for Chagas disease with at least 6 years after-treatment parasitological (T.cruzi
      qPCR), serological (IHA, EIA) and cardiological follow-up. Non-infected subjects were
      included as a control group for final cardiological evaluation.

      Treatment: benznidazole or nifurtimox, standard dose, for 60 days. Blood samples were
      collected at diagnosis, end-of-treatment and every 6-12 months thereafter.

      Electrocardiogram (ECG) was performed at diagnosis and every year after treatment.

      In this cohort, 24 hours ECG (Holter) and Speckle-tracking strain echocardiography study were
      performed at the end of follow-up for this study.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A cohort of CD treated children with at least 6 years post-treatment parasitological (T.
        cruzi qPCR), serological and cardiological follow-up. Treatment: benznidazole (Bz) or
        nifurtimox (Nftx), standard dose, for 60 days.
The Tolerability , Pharmacokinetics and Pharmacodynamics Study of HEC96719 Tablets in Healthy Adult Subjects
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of HEC96719, in
      healthy subjects.This study is the healthy adult subjects single ascending-dose research
    

Detailed description: 
      This study will evaluate the safety and tolerability of escalating single oral doses of
      HEC96719, and characterize the single-dose pharmacokinetics (PK) of HEC96719. Participants
      will receive either HEC96719 or HEC96719 placebo.
    

Intervention name(s): HEC96719 tablets; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): 0.1、0.2、0.5、1、2、3、4 mg HEC96719 tablet in day1; 0.1、0.2、0.5、1、2、3、4 mg Placebo tablet in day1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Biochemical and Physiological Changes Associated With Differing Durations of Relaxation Response Training
Condition: Stress
Study type: Observational

Summary: 
      We are looking at the effects of Stress Management and Relaxation Response training on stress
      hormones (like adrenalin and cortisol), immune function and physiology (heart rate, breathing
      rate, muscle tension).
    

Detailed description: 
      The primary aim of this study is to determine whether differing durations of relaxation
      response (RR) training will be associated with different degrees of change in physiological,
      psychological, hormonal, molecular and immunological markers. Prior studies have reported
      reduction on many of these parameters after 8 weeks of RR training. However, we now seek to
      understand the degree to which incremental decreases in these parameters are exhibited at 0,
      4, and 8 weeks of RR practice in 30 healthy adults. Furthermore, we will explore correlations
      between levels of exhaled nitric oxide or plasma nitrites/nitrates and oxygen consumption
      during RR elicitation. We will also examine any associations between changes in oxygen
      consumption and psychological factors, physiological parameters, and biochemical outcomes.
      Lastly, we will bank plasma and peripheral blood cells from these samples for future
      assessments of immune markers, cell typing and gene expression.
    

Intervention name(s): Relaxation Response + Stress Management Curriculum
Intervention type(s): Behavioral
Intervention description(s): Subjects will receive 8 weeks of Stress Management curriculum and guidance through 20 minute Relaxation Response with a research coordinator. They will also practice 20 minutes of Relaxation Response at home daily.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects ages 18-49.
      
Biospecimen description: 
      Whole blood Serum Plasma
    
Keywords: relaxation; relaxation response; meditation; nitric oxide; stress management; stress; Relaxation Techniques
Pharmacokinetic/Pharmacodynamic Study of Ilaprazole to Evaluate the Effect of CYP Genetic Polymorphism
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Ilaprazole is a novel proton pump inhibitor and metabolized by CYP3A4 and 2C19. Thus genetic
      polymorphisms of CYP3A4 and 2C19 may have effect on the pharmacokinetics and pharmacodynamics
      of Ilaprazole.
    

Detailed description: 
      Effects of genetic polymorphisms on the pharmacokinetics or pharmacodynamics were measured in
      healthy Korean volunteers
    

Intervention name(s): Ilaprazole
Intervention type(s): Drug
Intervention description(s): Ilaprazole 10 mg for 7 days
Other intervention name(s): 2-[(4methoxy-3-methyl)-2-pyridinyl] methylsulfinyl-; 5-(1H-pyrrol-1yl)-1H-benzimidazole
Intervention MeSH terms: Benzimidazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ilaprazole; Intragastric pH; Serum Gastrin; Pharmacokinetics
Rewarding Feedback in Motor Learning and Rehabilitation
Condition: Motor Performance; Motor Learning
Study type: Interventional

Summary: 
      The effect of rewarding vs. non-rewarding feedback on acquisition of a motor skill is
      investigated in a single blinded parallel group design. Reward consists of performance
      dependent monetary reward, or of knowledge of performance in selected (above average) trials.

      The investigators hypothesize improved motor skill learning and higher involvement of the
      dopaminsrgic system under rewarding vs. non-rewarding conditions.
    


Intervention name(s): Feedback about good performance; Feedback about good performance + money; Feedback about average performance
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
IV Cocaine Abuse: A Laboratory Model - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effects of desipramine DMI maintenance on
      cocaine taking and on the physiological and subjective effects of cocaine, including cocaine
      craving.
    


Intervention name(s): Desipramine
Intervention type(s): Drug
Intervention MeSH terms: Desipramine
Primary purpose: Treatment
Keywords: crack cocaine
Randomized, Crossover Safety and Pharmacokinetics Study of PT010
Condition: COPD
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and Pharmacokinetics of Two Doses of PT010 in Healthy Adult Subjects of Japanese
      Descent Following a Single Dose and After Chronic Dosing for 7 Days.
    

Detailed description: 
      This is a Phase I, single-center, randomized, double-blind, placebo-controlled, two period,
      ascending dose, cross-over study to assess safety and PK of two doses of PT010 in healthy
      adult subjects of Japanese descent. Safety and PK will be assessed following a single dose
      and during twice-daily (BID) chronic dosing for 7 days.
    

Intervention name(s): PT010 Dose 1; PT010 Dose 2; Placebo MDI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.; PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.; Placebo MDI. Administered as 2 inhalations
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Volunteers