bioihbjkbjnl/mcl2 huggingface dataset:
Diagnostic Performances of Computed TomographIc Coronary Angiography and Intravascular Ultrasound
Condition: Diagnosis Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      Diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect
      ischemia related stenosis (function). Coronary angiography (CAG) is a gold standard invasive
      techniques, but has several limitations. Intravascular ultrasound (IVUS) provides tomographic
      intra-luminal images. Coronary computed tomographic angiography (CCTA) is helpful to assess
      precise anatomical information. Optimal functional criteria and their accuracy of IVUS and
      CCTA by fraction flow reserve (FFR) have not been compared yet.
    

Detailed description: 
      Correlation between CCTA, IVUS and FFR will be evaluated. The presence of myocardial ischemia
      will be assessed by fractional flow reserve (FFR).

      Diagnostic performance (sensitivity, specificity, positive predictive/negative predictive
      values and diagnostic accuracy) of each modality will be assessed and compared.
    

Intervention name(s): diagnostic procedures CCTA, CAG, IVUS and FFR
Intervention type(s): Procedure
Intervention description(s): Diagnostic procedures including computed tomography, coronary angiography, intravascular ultrasound, fractional flow reserve were performed in the patients suspected ischemic heart disease.
Other intervention name(s): CCTA, Aquillion, Toshiba; IVUS, InVision Gold, Volcano and I-Lab, Boston; FFR, Pressure Wire, St.Jude medical
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients who underwent CCTA, IVUS and FFR Stable clinical condition
      
Keywords: computed tomography; intravascular ultrasound; coronary stenosis; fractional flow reserve
N-3 Fatty Acids as the First-line Antidepressant Therapy: From Biomarkers to Clinical Subtypes
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Investigate the clinical subtypes and the biological markers to personalize the use n-3 PUFAs
      (EPA, DHA, and EPA/DHA) in MDD.
    

Detailed description: 
      In this proposal, the investigators aim to explore the clinical subtypes and biological
      markers to personalize the use n-3 PUFAs (EPA, DHA, and EPA/DHA) in MDD. By stratifying the
      subjects with (versus without) remission and treatment response, the biological markers are
      expected to have important prediction effects in future clinical practice.
    

Intervention name(s): Omega-3 fatty acids
Intervention type(s): Dietary Supplement
Intervention description(s): 12-week double-blind, randomized controlled trial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Depression, omega-3 fatty acids, nutritional intervention
Feasibility of Mid-frequency Ventilation in Newborns With RDS: Randomized Crossover Pilot Trial
Condition: Respiratory Distress Syndrome, Newborn
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Respiratory distress syndrome (RDS) is the most common respiratory disorder in preterm
      infants. Despite improved survival of extremely premature infants with RDS, complications
      related to mechanical ventilation still occur. This trial will attempt to maintain adequate
      gas exchange at a rapid rate, short inspiratory time, low tidal volume, and low peak
      inspiratory pressure in infants with respiratory distress requiring mechanical ventilation. A
      cross over design will be used to test the hypothesis whether mid-frequency ventilation in
      preterm infants with RDS requiring mechanical ventilation will reduce the peak inspiratory
      pressure requirement when compared to conventional mechanical ventilation.
    


Intervention name(s): Conventional Pressure Controlled SIMV; Mid-frequency Ventilation
Intervention type(s): Procedure; Other
Intervention description(s): Initial ventilatory settings per clinical physician's discretion-tcCO2 & Saturation (SAT) monitoring. Adjust vent setting approximately every 15min with a goal of: SAT 88-95%, tcCO2 45-55, pH greater than or equal to 7.25. Once goals reached, ventilatory strategy will crossed over to other intervention.; Ventilatory parameters include: max possible rate between 61-150 breaths/min; Shortest inspiration time (Ti) and expiration time (Te), but completed inspiration and expiration on pulmonary graphics. Stepwise weaning of PIP by 1 cm H20 to maintain tcCO2 at baseline. If measured PEEP - delivered PEEP generated is >/= to 1cm H2O, PEEP is reduced to baseline value. Adjustments will be made to PIP, then rate for pH and CO2 changes; FiO2, then PIP for FiO2 changes. Target goal blood gas parameters (same as baseline) Saturations 88-95%; tcCO2 45-55 mmHG; pH >/= 7.25. Maximum period of 2 hours. When goals met, or 2 hours in period, reverted back to SIMV at baseline settings
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Conventional mechanical ventilation; Mid-frequency ventilation; Respiratory Distress Syndrome; Preterm Newborn Infant; Mean Airway Pressure; Mean Arterial Pressure; Mean Peak Inspiratory Pressure
Benefits of Tanning in Fibromyalgia Patients
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional

Summary: 
      -  To establish whether ultraviolet light exposure acutely reduces perceptions of pain in
           patients with fibromyalgia.

        -  To establish whether a series of UV light exposures has a cumulative effect on
           fibromyalgia pain.
    

Detailed description: 
      Fibromyalgia is a common chronic disorder characterized by widespread pain and fatigue. It
      occurs primarily in women, especially women of childbearing age. The effectiveness of
      treatment for this disorder is limited, and alternative medical treatments are commonly used.

      Ultraviolet (UV) light exposure gives a sense of relaxation. It is unknown whether UV
      exposure has any effect on pain, particularly in patients with fibromyalgia. Through studies
      performed with RO3 funding from the National Institute of Drug Abuse (NIDA), we demonstrated
      that in frequent tanners, appearance is less important than UV-induced relaxation in
      motivating tanning behavior. Moreover, we determined that UV light has reinforcing properties
      apart from any psychosocial benefits of having a tan. One subject in our study reported low
      back pain relief from the UV exposure condition.

      This is a two-year proposal that is the beginning of a long-term plan to assess whether
      indoor tanning ultraviolet light exposure has a therapeutic effect for patients with chronic
      pain. To this end, we will determine the effect of UV light on fibromyalgia pain in a
      controlled, double blind clinical trial of UV exposure. This approach is carefully designed
      to separate the effects of UV exposure on pain from potential confounds associated with the
      tanning procedure, including any perceived benefits of having a tan. The results of this
      study will increase our understanding of the specific influence of UV light on persistence in
      tanning behavior.
    

Intervention name(s): UVB; Non-UVB
Intervention type(s): Device; Procedure
Intervention description(s): UVB exposure by a tanning bed; Non-UVB exposure by a tanning bed
Other intervention name(s): Ultraviolet Light
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tanning; Musculoskeletal; Fibromyalgia Syndrome
Changes in Cerebral Oxygenation and Cognitive Functions
Condition: Hypotension; Controlled; Cognitive Dysfunction
MeSH terms: Hypotension; Cognitive Dysfunction
Study type: Observational

Summary: 
      The present study aimed to assess the influence of nitroglycerin and esmolol-induced
      hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and
      postoperative cognitive function in patients undergoing nasal surgery.
    


Intervention name(s): Esmolol; Nitroglycerin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nitroglycerin; Esmolol
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        - required controlled hypotension scheduled for nasal surgeries
      
Keywords: cerebral oxygenation; cognitive function; esmolol; nitroglycerine
Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression
Condition: Covid19; Progression
MeSH terms: COVID-19; Disease Progression
Study type: Interventional
Phase: Phase 3

Summary: 
      Brief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in
      reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance.

      Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate
      Phase: Phase III
    

Detailed description: 
      This study explores efficacy of HCQ (400mg BD on D0 and 200mg BD D1-D5) in reducing
      progression of Mild Covid-19 patients and decreasing viral load.

      Participants of study will be randomized 2:1 to receive either Active drug or standard of
      care (SOC) treatment respectively. We aim to demonstrate reduced COVID-19 progression and
      early viral clearance in individuals on HCQ therapy.
    

Intervention name(s): HCQ
Intervention type(s): Drug
Intervention description(s): Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days
Other intervention name(s): HCQ + Standard of Care (SOC)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization rules were designed by Dr. Wasim Alamgir together with principal investigators and implemented by an independent statistician who was not involved in data analysis. Stratified random sampling was applied to stratify all eligible patients according to age, gender and comorbidities. Computerized random number generator was used and allocation was done in 2:1 sequence. Cards with each group assignment number randomly generated by computer were placed in sequentially numbered envelopes that were opened as the patients were enrolled
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; viral clearance; , mild infection; disease progression; trial; HCQ
Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical study is to evaluate the safety and immunogenicity of a 3-dose
      schedule (2-dose primary series followed by a toddler dose) of pneumococcal conjugate vaccine
      (PCV) as one of the currently recommended schedules by the World Health Organization (WHO)
      Strategic Advisory Group of Experts (SAGE) on Immunizations and practiced in many countries.

      The primary hypotheses are that V114 is non-inferior to Prevenar 13™ for the 13 shared
      serotypes based on response rates and on anti-pneumococcal polysaccharide (PnPs)
      serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) at 30 days
      following Dose 3; that V114 is superior to Prevenar 13™ for the 2 serotypes unique to V114
      based on the response rates and on anti-PnPs serotype-specific IgG GMCs at 30 days following
      Dose 3; and that Vaxelis™ administered concomitantly with V114 is non-inferior to Vaxelis™
      administered concomitantly with Prevenar 13™ at 30 days following Dose 3 for each antigen
      included in Vaxelis™.
    


Intervention name(s): V114; Prevenar 13™; Vaxelis™; M-M-R®II; VARIVAX™
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.; 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.; Intramuscular 0.5 mL single dose; Subcutaneous 0.5 mL single dose; Subcutaneous 0.5 mL single dose
Other intervention name(s): VAXNEUVANCE™; Pneumococcal 15-Valent Conjugate Vaccine; Prevnar 13™; Measles, Mumps, and Rubella Virus Vaccine Live; Varicella Vaccine Live
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy Study of Korean Red Ginseng to Treat Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Korean Red Ginseng are effective in the
      treatment of the residual symptoms of depression as an adjuvant treatment.
    

Detailed description: 
      Thirty-five female outpatients aging from 18 to 65 years, who were remitted from major
      depression with residual symptoms (Montgomery Asberg Depression Rating Scale, MADRS ≤ 12),
      were given Korean red ginseng at doses of 3g / day during 8 weeks.
    

Intervention name(s): Korean Red Ginseng
Intervention type(s): Dietary Supplement
Intervention description(s): 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Major depressive disorder; Residual symptoms; Korean red ginseng
Recovery of Ventilation After Anesthesia for Laparoscopic Nephrectomy
Condition: Ventilatory Depression; Postoperative Respiratory Complication
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      The purpose of this randomized, controlled feasibility investigation is to characterize
      pharmacologically induced ventilatory depression after anesthesia and examine how is affected
      by the amount of supplemental oxygen patients are receiving in the immediate postoperative
      period.
    

Detailed description: 
      The purpose of this study is characterize pharmacologically induced ventilatory depression
      after anesthesia and examine how is affected by the amount of supplemental oxygen patients
      are receiving in the immediate postoperative period, since hyperoxemia (ie., higher than
      necessary partial pressure of oxygen in the arterial blood) has been associated with
      ventilatory depression via suppression of the hypoxic ventilatory drive.

      In this feasibility randomized controlled trial, the investigators plan to estimate and
      compare the cumulative segment of time during which the transcutaneous partial pressure of
      carbon dioxide will exceed an upper limit of 45 mmHg (i.e., TcPCO2 > 45 mmHg) for the
      90-min-long post-anesthesia period, between the conventional (titrated to an oxygen
      saturation > 96%) and the conservative (titrated to O2 saturation 90 -94%) O2 supplementation
      interventions.

      Hypothesis: Conservative use of O2 (titrated to an SpO2: 90 - 94%), will be associated with
      less hypoventilation (i.e., less time spent with an TcPCO2 > 45 mmHg) during recovery from
      general anesthesia, compared to liberal O2 supplementation (SpO2 > 96%).
    

Intervention name(s): Oxygen gas -Conservative; Oxygen gas -Liberal
Intervention type(s): Other; Other
Intervention description(s): Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90% and 94%.; Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) higher than 96%.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the post-anesthesia care unit (PACU), participants will be randomized to receive conservative (titrated to an SpO2 between 90 and 94%) versus liberal (titrated to SpO2 > 96%) oxygen supplementation, via a non-rebreather mask.
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AL01211 in Healthy Volunteers
Condition: Autosomal Dominant Polycystic Kidney
MeSH terms: Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of Oral AL01211 in healthy volunteers
    

Detailed description: 
      This study is a Phase 1, first in human (FIH), randomized, double-blind, placebo-controlled
      study of AL01211 in healthy adult participants

      The study consists of two parts:

      Part A will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      AL01211 in a single ascending dose escalation study in approximately 40 healthy adult
      participants.

      Part B will investigate the safety and tolerability, pharmacokinetics, and pharmacodynamics
      of AL01211 in a multiple ascending dose escalation study in approximately 40 healthy adult
      volunteers.
    

Intervention name(s): AL01211 or Placebo (Part A); AL01211 or Placebo (Part B)
Intervention type(s): Drug; Drug
Intervention description(s): Five dose groups with doses ranging from 2mg to 60 mg; Five dose groups with doses ranging from 2-60 mg daily. Each separate dose given for 14 days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Clinical Trial for Analysis of Intestinal Microbiome Affecting PK, PD, and Safety of Metformin
Condition: Human Microbiome
Study type: Interventional

Summary: 
      This clinical trial is intended to evaluate the effects of the changes in intestinal
      microbiome by antibiotics (PO vancomycin) on the pharmacokinetic /pharmacodynamic and safety
      profiles of metformin in healthy male volunteers.
    


Intervention name(s): Metformin (part 1); Vancomycin; Metformin (part 2)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d~19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch).; 11d: Vancomycin 250 mg bid, 12~17d: Vancomycin 500 mg bid; 1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)
Other intervention name(s): Diabex Tab., 500 mg; Vancozin cap., 250 mg; Diabex Tab., 500 mg
Intervention MeSH terms: Metformin; Vancomycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Long-term Trial on Growth Hormone Deficiency in Adults (GHDA)
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Japan. This protocol describes an extension trial to supply hGH to
      subjects who wish continuous treatment after the long-term Phase 3 trial (GHLiquid-1519)
      until hGH products have been approved for GHDA in Japan.
    


Intervention name(s): somatropin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Niaspan on Endothelium-Dependent and Endothelium-Independent Vascular Reactivity (0000-093)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the inter- and intra subject variabilities of flow-mediated dilation
      (FMD) of brachial artery and nitroglycerin (GTN) induced dilation of brachial artery.
    


Intervention name(s): Niaspan; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral doses of 2000 mg of Niaspan once daily for 7 days.; Oral doses of placebo once daily for 7 days.
Intervention MeSH terms: Niacin; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
OC000459 Dose Finding Study in Patients With Mild to Moderate Persistent Asthma
Condition: Mild to Moderate Persistent Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a double blind, randomised, 4 arm, parallel group, placebo controlled study of
      three dose levels of OC000459 tablets in patients with asthma controlled by beta agonist
      drugs alone. This study will compare the patients on OC000459 at three different dose levels
      (25mg once daily, 100mg twice daily and 200mg once daily) with patients on placebo after
      dosing for 17 weeks. The trial will be undertaken in an outpatient population. Each treatment
      arm will consist of at least 110 subjects. The objective is to assess the efficacy of these
      dose levels on the patients asthma.
    


Intervention name(s): OC000459 or placebo
Intervention type(s): Drug
Intervention description(s): Pills, active and/or placebo given twice daily for 17 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; treatment; placebo; efficacy; safety
Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux.
Condition: Esophageal Disease
MeSH terms: Gastroesophageal Reflux; Esophageal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a single-center, randomized, open-label clinical study to assess the treatment
      response of high-dose rabeprazole compared with standard-dose rabeprazole in patients with
      extra-esophageal manifestations of gastroesophageal reflux disease.
    

Detailed description: 
      Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the
      esophagus. This disease can be classified in to two subtypes according to the symptoms;
      Typical symptoms such as heartburn and regurgitation, and atypical symptoms (extra-esophageal
      symptoms) such as chronic cough, asthma, non-cardiac chest pain, globus sensation, etc.

      Acid suppression with proton pump inhibitors is the mainstream of therapy for the
      extra-esophageal manifestation as well as the typical symptoms of gastroesophageal reflux
      disease.

      However, there is controversy about the efficacy of proton pump inhibitors on
      extra-esophageal reflux.

      Therefore, we aimed to assess the effect of proton pump inhibotor (rabeprazole) on the
      extra-esophageal manifestation of gastroesophageal reflux disease, through comparison of
      treatment response with high-dose and standard-dose rabeprazole.
    

Intervention name(s): Rabeprazole 20mg bid; Rabeprazole 20mg qd
Intervention type(s): Drug; Drug
Intervention description(s): Rabeprazole 20mg tablet b.i.d.; Rabeprazole 20mg tablet q.d.
Other intervention name(s): Rabiet; Rabiet
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux