bioihbjkbjnl/mcl2 huggingface dataset:
Korea Atherosclerosis Study-3
Condition: Cardiovascular Diseases; Cardiovascular Mortality; All-cause Mortality
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      Multidetector-row Computed Tomography (CT) has been introduced for use in the diagnosis of
      coronary heart disease. The investigators aimed to characterize coronary artery disease in
      subjects with cardiovascular risk or not, and in particular plaque natures depending on
      different status of cardiovascular risk. Especially,the investigators will evaluate the
      relationships between the pericardial fat and severity of stenosis as well as plaque
      characteristics using logistic regression models.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        positive cardiovascular risks or not
      
Biospecimen description: 
      Biochemical paramteres including lipid, glucose, insulin, and other novel cardiometabolic
      factors
    
Keywords: coronary artery disease; cardiovascular risk; pericardial fat
Safety and Efficacy Study of Regulatory T Cell Therapy in Liver Transplant Patients
Condition: End-stage Liver Disease
MeSH terms: Liver Diseases; End Stage Liver Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      'ThRIL' aims to explore the feasibility, safety and efficacy of TR002, a regulatory cell
      therapy, as adjunct immunosuppressive treatment in the context of liver transplantation
    

Detailed description: 
      Stage I: To evaluate the safety of administering TR002 to liver transplant recipients.

      Stage II: To evaluate the efficacy of TR002 administration in allowing for the
      discontinuation of immunosuppressive therapy in liver transplant recipients.
    

Intervention name(s): Autologous regulatory T cell product
Intervention type(s): Drug
Intervention description(s): Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose). The patients also receive rabbit Antithymocyte Globulin (rATG), tacrolimus, and sirolimus.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability of Increasing Pramipexole Doses of Oral Extended Release (ER) Tablets in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the studies are:

        -  To demonstrate similar total exposure between pramipexole ER fasted and pramipexole ER
           fed after multiple administration of the highest daily dose of 4.5 mg q.d. and to reveal
           any food effect leading to uncontrolled release

        -  To investigate the relative bioavailability of the ER-formulation of pramipexole in
           comparison to the IR-formulation at the highest daily dose of 4.5 mg after multiple
           dosing

        -  To demonstrate dose proportionality between the dose strengths of the pramipexole ER
           formulation of 0.375, 0.75, 1.5, 3.0, and 4.5 mg after multiple daily (q.d.) dosing
    


Intervention name(s): Pramipexole ER tablets; Pramipexole IR tablets; Placebo matching Pramipexole ER tablets; Placebo matching Pramipexole IR tablets; Standard high-fat breakfast
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AHT956 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and tolerability of ascending single oral doses of AHT956
      in healthy subjects
    


Intervention name(s): AHT956
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: safety, tolerability, pharmacokinetics, pharmacodynamics, AHT956
A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)
Condition: Cervical Cancers; Vulvar Cancers; Vaginal Cancers; Genital Warts
MeSH terms: Condylomata Acuminata; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women
      between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants
      will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the
      Base Study. Participants who receive placebo in the Base Study will be eligible to receive
      vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.
    


Intervention name(s): V503; Placebo to V503
Intervention type(s): Biological; Biological
Intervention description(s): V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension; Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Cervical cancer; Genital warts; Human papillomavirus vaccine; GARDASIL™
Evaluation of the Efficacy of Different Strategies to Treat Anemia in Mexican Children
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional

Summary: 
      Anemia continues to be a major public health problem in many regions of the world and it is
      still not clear which strategy is more effective in children population in terms of adherence
      and efficacy. The objective was to evaluate the efficacy and acceptance of several strategies
      that have been recently recommended to treat anemia on anemic children (6 to 43 mo):Iron
      supplement, iron+folic acid supplement, a multiple micronutrients supplement a micronutrient
      fortified complementary food in the form of porridge powder or zinc+iron+ascorbic acid
      fortified water.
    


Intervention name(s): Iron; Multiple micronutrients supplement; micronutrient fortified porridge powder; Iron and ascorbic acid fortified water; Iron plus folic acid supplement
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Daily 20mg of ferrous sulfate in liquid solution during 4 months; Daily supplement with 10mg of iron plus several micronutrients following a formula designed to treat anemia in indigenous population in Mexico. During 4 months.; Daily powdered complementary food designed for a national program in Mexico with 10mg of iron plus several micronutrients during 4 months; A drink water product fortified with 6.7 mg ofiron, zinc and ascorbic acid. This product was asked to be used for drinking and for cooking for the child during 4 months.; Daily liquid solution following the daily iron (12.5mg)and folic acid recommendation of UNICEF to treat anemia during 4 months
Intervention MeSH terms: Iron; Trace Elements; Folic Acid; Ascorbic Acid; Micronutrients
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anemia; Iron; Children; Micronutrients
The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients
Condition: Peptic Ulcer
MeSH terms: Peptic Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      This study assessed the effect of tailored eradication therapy according to Clarithromycin
      resistance in Helicobacter pylori patients.
    

Detailed description: 
      This study assessed the effect of tailored eradication therapy according to Clarithromycin
      resistance in Helicobacter pylori patients.

      The patients with gastric or duodenal ulcer by endoscopy were registered at the study and
      inspected Rapid Urease test, Biopsy, IgG-Hp antibody.

      The tailored eradication therapy was prescribed to patients that confirmed Helicobacter
      pylori positive in two or more of among the three tests for 14 days. Through this, This study
      is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of
      Ilaprazole 10mg qid treatment
    

Intervention name(s): Ilaprazole; Amoxicillin; Clarithromycin; Metronidazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ilaprazole 10mg 1tablet qid(4 times/day); Amoxicillin 500mg 1capsule qid(4times/day); Clarithromycin 500mg 1tablet bid(2times/day); Metronidazole 250mg 2tablets tid(3times/day)
Other intervention name(s): Noltec®; Pamoxin®; Clafaxin®; Flasinyl®
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Omega-3 Fatty Acid Dietary Intervention (O3DI)
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      Elevated cholesterol, including triglyceride levels, can lead to the development of
      cardiovascular disease in adulthood. A diet that is rich in omega-3 fatty acids (O3FA) can
      improve triglyceride levels in a way that is safe and does not require medication.

      This is a single-center, prospective, unblinded, randomized-controlled dietary intervention
      study to assess the impact of an omega-3 fatty acid diet compared to a standard lifestyle
      intervention on serum triglyceride in patients with hypertriglyceridemia. The study consists
      of an 8-week dietary treatment period followed by an 8-week observation period.
    


Intervention name(s): Diet intervention; Control group
Intervention type(s): Other; Other
Intervention description(s): The intervention group will receive diet counseling and information to implement a standard lifestyle intervention plus omega-3 fatty acid enriched foods Diet assessment and counseling provided throughout study.; The control group will receive diet counseling and information to implement a standard lifestyle intervention Diet assessment and counseling provided throughout study.
Other intervention name(s): Standard lifestyle intervention + omega-3 fatty acid enriched diet; Standard lifestyle intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Low Dose Morphine to Relieve Dyspnea in Acute Respiratory Failure (OPIDYS)
Condition: Acute Respiratory Failure
MeSH terms: Respiratory Insufficiency; Dyspnea; Respiratory Distress Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates a pharmacological intervention to relieve dyspnea in intensive care unit
      patients. Indeed, opioids can be particularly beneficial since 1) dyspnea and pain share many
      similarities, 2) the benefit of opioids on dyspnea has been clearly demonstrated in other
      populations. However, to date, data regarding the impact of morphine on dyspnea in intensive
      care unit patients admitted for acute respiratory failure are scarce. There may be a
      reluctance of physicians to prescribe opioids that is not scientifically justified.

      The study will focus on patient reported outcome (PRO) criteria. The ultimate goal of this
      pilot study is to design the protocol of a future pragmatic trial.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled, parallel-group, single-center phase 2 pilot
      study.The experimental group will receive an intravenous titration of morphine followed by a
      subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined
      protocol. The control group will receive placebo NaCl 0.9% administered according to the same
      protocol as the experimental arm Patients will be randomized 1:1 between low-dose titrated
      morphine (experimental group) and placebo (control group). The other treatments will be
      similar in both groups, according to the protocol and the recommendations.

      Severe dyspnea will be assessed for regularly Patients will be followed for 48 hours: 24-hour
      treatment duration, evaluation of primary endpoint for first 24 hours, collection of adverse
      events for 48 hours.
    

Intervention name(s): Chlorhydrate de morphine; NaCl 0,9%,
Intervention type(s): Drug; Drug
Intervention description(s): The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol; The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled, parallel-group,single center, phase 2 pilot study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute respiratory failure; Dyspnea; Opioids; Comfort; Intensive care unit
Long-term Immunogenicity and Safety of Fourth Administration of Boryung Cell-Culture Japanese Encephalitis Vaccineinj
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A multi-center, open, phase 4 clinical trial to assess the long-term immunogenicity and
      safety of fourth administration of Boryung Cell-Culture Japanese Encephalitis Vaccine inj.
      and to conduct an exploratory investigation on vaccine interchangeability in Korean children
      aged 6 years who received primary 3 doses with ENCEVAC® or Japanese Encephalitis Vaccine-GCC®
      inj.
    

Detailed description: 
      This is a follow-up study of KD287-BR-CT-301 (ClinicalTrials.gov identifier: NCT01150942), a
      phase 3 study to investigate the efficacy and safety of a cell-culture Japanese encephalitis
      vaccine (ENCEVAC®) compared with that of a mouse brain-derived Japanese encephalitis vaccine
      (Japanese Encephalitis vaccine-GCC® inj). Subjects participated in KD287-BR-CT-301 study were
      to receive 3 doses of Japanese encephalitis vaccine (JEV) assigned by randomization from the
      age of 12 months and those subjects who completed the 3 doses of JEV are the target
      population in this study. The purpose of this study is to investigate the long-term
      immunogenicity and safety of the booster (fourth) dose of JEV, which will be given as Boryung
      Cell-Culture Japanese Encephalitis Vaccine inj, proven to be same with ENCEVAC® but
      manufactured by a different manufacturer.
    

Intervention name(s): Japanese encephalitis vaccine
Intervention type(s): Biological
Intervention description(s): Dosage and administration: After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose is administered subcutaneously in the lateral aspect of the upper arm.
Other intervention name(s): Boryung Cell-Culture Japanese Encephalitis Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Vagus Nerve Stimulation for Post-COVID Syndrome
Condition: Long COVID; Vagus Nerve Stimulations; Heart Rates; Autonomic Nervous System Disorders
MeSH terms: Post-Acute COVID-19 Syndrome; Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias
Study type: Interventional

Summary: 
      The aim of this study is to increase parasympathetic activity and decrease the severity of
      symptoms by providing vagal stimulation with the t-VNS method in order to suppress the
      increased sympathetic activity in patients with prolonged Covid symptoms.The main question[s]
      it aims to answer are:

      Question 1:Is left ear transcutaneous vagus nerve stimulation effective in suppressing the
      symptoms of patients in Post Covid syndrome?

      Question 2:Is bilateral auricular transcutaneous vagus nerve stimulation effective in
      suppressing the symptoms of patients in Post Covid syndrome?

      A 5-minute heart rate variability measurement will be performed to measure the effectiveness
      of vagus nerve stimulation in participants.HRV is a non-invasive method used to evaluate ANS
      activity and is a measure of heart rate change over a period of time
    


Intervention name(s): Auricular transcutaneous vagus nerve stimulation
Intervention type(s): Device
Intervention description(s): Transcutaneous vagus nerve stimulation (taVNS) was performed with an FDA-approved Vagustim stimulation device and an electrode-shaped earpiece. In the participants included in the study and randomized to two groups, i) left ear taVNS was applied to the first group and ii) double-ear taVNS was applied to the second group.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Phase Angle and Mortality in Patients With Cirrhosis
Condition: Malnutrition
MeSH terms: Malnutrition; Fibrosis
Study type: Observational

Summary: 
      A few PhA cut-off points have been proposed to define malnutrition in cirrhosis, and they
      have proven to be useful in prognosticating severity of the disease and mortality. However,
      PhA needs specific validation in different ethnic groups. The aim of this study was to
      evaluate the PhA cut-off value that would best define malnutrition and predict mortality in
      patients with liver cirrhosis.
    

Detailed description: 
      Malnutrition is a frequent complication of cirrhosis, and it has been associated with a more
      severe disease and decompensating events. Despite its relevance, there is no gold standard
      for nutritional assessment in cirrhosis, and intrinsic pathophysiologic changes make
      biochemical markers and traditional methods used to evaluate malnutrition unreliable. Phase
      angle (PhA) obtained from bioelectrical impedance has been successfully used as a nutritional
      marker in several diseases such as chronic renal failure, cancer, and HIV, where it has been
      associated with prolonged in-hospital stay and mortality. In cirrhosis, research linking
      malnutrition to increased mortality has yielded conflicting results, likely due to the lack
      of a gold standard. A few PhA cut-off points have been proposed to define malnutrition in
      cirrhosis, and they have proven to be useful in prognosticating severity of the disease and
      mortality. However, PhA needs specific validation in different ethnic groups. The aim of this
      study was to evaluate the PhA cut-off value that would best define malnutrition and predict
      mortality in patients with liver cirrhosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Population will be selected from the Liver Clinic at the Department of Gastroenterology in
        a tertiary care center in Mexico
      
Keywords: phase angle; liver cirrhosis; mortality; malnutrition
Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS)
Condition: Sleep Apnea, Obstructive; Exercise Training Therapy
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      There are two types of treatments depending on the severity of Obstructive Sleep
      Apnea/Hypopnea Syndrome (OSAS): - for the treatment of severe (AHI> 30/h), the standard
      treatment is Continuous Positive Airway Pressure (CPAP). If it proved effective in reducing
      excessive daytime sleepiness and associated cardiovascular risk, compliance of patients 4
      years of treatment falls below 70%. - Treatment of moderate (AHI between 15 and 30/h),
      lifestyle measures, the bracing of mandibular advancement and / or possibly the head and neck
      surgery can be proposed. These treatments include side effects and their effectiveness is
      very controversial.Il therefore seemed interesting to test the impact of physical activity
      through a standardized training program to re personal effort on the development and
      improvement of OSAS patients with a sedentary moderate to severe OSAS (AHI between 15 and 40
      / h) The main assumption is that the ESR could eventually delay the initiation of treatment
      with CPAP in severe OSAS or an alternative therapeutic relevance in the moderate OSAS and
      severe in patients who can not tolerate conventional treatment(CSF). The main objective of
      this biomedical research is to evaluate the effects of a program of REE in ambulatory index
      of hourly apneas / hypopneas (AHI = marker of severity of OSAS) .- objectives specify 2AIR
      effects of REE on the quality of sleep (TxSLP) and daytime symptoms (EDS objective fatigue)
      on the one hand and the other on the metabolism (OV, SM, IR) and markers of LCR
      (inflammation, oxidative stress , endothelial function).
    


Intervention name(s): training and educational program; educational program
Intervention type(s): Other; Other
Intervention description(s): 8 weeks; 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea/Hypopnea Syndrome; Exercise training program; Inflammation; Oxidative Stress; Insulin resistance
Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in The United States of America. The aim of this trial is to
      investigate Safety, Tolerability, Pharmacokinetics (the exposure of the trial drug in the
      body) and Pharmacodynamics (the effect of the investigated drug on the body) of Multiple
      Dosing of NNC0174-0833 in Subjects with Obesity or Overweight.
    


Intervention name(s): NNC0174-0833; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Doses of NNC0174-0833, dosed either once daily or once weekly; Dosed either once daily or once weekly
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment