bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of TB-840 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      TB-840(Agonist of RORα) is a candidate for NASH treatment that activates
      RORα(Retinoid-related orphan receptor) and its target validation for RORα and potential as a
      NASH treatment. This study is a dose block-randomized, double-blind, placebo-controlled,
      single- and multiple-ascending dose study. For each dose group, 6 subjects will be randomly
      assigned to the test group (TB-840) and 2 subjects will be randomly assigned to the control
      group (placebo). Adverse event (AE) monitoring, physical examination, vital signs, ECG,
      clinical laboratory test will be done for safety and tolerability assessment, and blood and
      urine samples will be collected for Pharmacokinetic (PK) assessment.
    


Intervention name(s): Comparison of TB-840 treatment with Placebo
Intervention type(s): Drug
Intervention description(s): Single dose or Multiple Dose of TB-840 treatment
Other intervention name(s): TB-840
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Retinoid-related orphan receptor alpha; RORα; Agonist of RORα
Nitric Oxide-mediated Cardioprotection During Cardiac Surgery With Cardiopulmonary Bypass
Condition: Coronary Artery Disease; Coronary Artery Bypass; Cardiopulmonary Bypass; Nitric Oxide; Reperfusion Injury, Myocardial
MeSH terms: Coronary Artery Disease; Reperfusion Injury; Myocardial Reperfusion Injury
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This prospective randomized study elucidates the effects of exogenous nitric oxide delivered
      to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion
      injury during coronary artery bypass graft surgery with cardiopulmonary bypass.
    

Detailed description: 
      The aim of this study is to investigate the effects of exogenous nitric oxide (NO) delivered
      to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion
      injury during coronary artery bypass graft surgery (CABG) with cardiopulmonary bypass (CPB).
      A total of 60 patients with ischemic heart disease referred for CABG with CPB are included in
      prospective randomized study. Patients are randomized to receive standard treatment or
      surgery based on modified CPB protocol. According to modified protocol, 40-ppm NO is supplied
      to the CPB circuit during CABG. The primary endpoints are changes in cardiac troponin I
      (cTnI) levels at 6, 24, and 48 hours after surgery compared with baseline. The secondary end
      points are the changes in the levels of creatine kinase-muscle/brain (CK-MB) compared with
      baseline and vasoactive inotropic score (VIS) at 6, 24, and 48 hours. NO supplied to the CPB
      circuit exertes cardioprotective effect. Changes in cTnI, CK-MB, and VIS are considered
      indictors of the presence or absence of cardioprotective action of NO supplied to the CPB
      circuit.
    

Intervention name(s): Nitric Oxide; Standard CPB
Intervention type(s): Drug; Other
Intervention description(s): 40 ppm of exogenous gaseous nitric oxide is supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting.; Standard protocol of delivery of air gas mixture to the cardiopulmonary bypass circuit
Other intervention name(s): Cardiopulmonary bypass
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-center prospective, randomized, placebo-controlled study
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cardioprotection; Ischemia-reperfusion injury; Nitric oxide; Cardiopulmonary bypass; Coronary artery bypass grafting
The Effect of the Non-invasive Brain Stimulation on the Speech Fluency Enhancement
Condition: Stuttering/ Developmental
MeSH terms: Stuttering
Study type: Interventional

Summary: 
      The aim of this study is to determine the effectiveness of concurrent transcranial direct
      current stimulation (tDCS) and fluency training in adults with developmental stuttering. We
      examine the severity of stuttering to investigate the effect of treatnment. In the control
      group the anodal tDCS and DAF will applied on six consecutive days (1 milliampere [mA] for 20
      mins per day), and the control group will received the sham stimulation and DAF for the same
      time. The severity of stuttering measured by means of tasks and questionnaires before and
      after treatment sessions and 6 weeks after intervention.
    


Intervention name(s): Anodal tDCS; fluency intervention/ Delayed Auditory Feedback; Sham tDCS
Intervention type(s): Device; Behavioral; Device
Intervention description(s): 1 mA anodal tDCS positioned over left superior temporal gyrus and the cathode placed over the occipital lobe. The tDCS stimulation will be delivered for 20 minutes on 6 intervention days.; Each participant complete three tasks include reading, conversation, and narration. Delayed auditory feedback will be used during these tasks. Each treatment session will take 20 minutes.; The anodal tDCS positioned over left superior temporal gyrus and the cathode placed over the occipital lobe. The current of sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes on 6 intervention days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
52-104 Week Off-therapy Second Extension to Study CSPP100A2365
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      52-104 week off-therapy second extension to study CSPP100A2365 to assess growth and
      development in pediatric hypertensive patients previously treated with aliskiren in studies
      SPP100A2365 and SPP100A2365E1
    


Intervention name(s): SPP100
Intervention type(s): Drug
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric hypertensive patients 6 - 17 years of age previously treated with aliskiren in
        studies CSPP100A2365 and/or CSPP100A2365E1
      
Keywords: Pediatric; hypertension; aliskiren
Clinical Evaluation of the SEQureDx Trisomy Test in Low Risk Pregnancies
Condition: Aneuploidy; Down Syndrome; Noninvasive Prenatal Screening
MeSH terms: Down Syndrome; Aneuploidy; Trisomy
Study type: Observational

Summary: 
      Pregnant women with low risk indicators for fetal chromosomal aneuploidy will be enrolled.
      Study blood will be collected in the first or second trimester at a scheduled prenatal
      screening visit, processed to plasma, and stored frozen until analysis. Each pregnancy will
      be followed until delivery and the birth outcome recorded.
    


Intervention name(s): SEQureDx Trisomy Test
Intervention type(s): Device
Intervention description(s): Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pregnant with low risk for fetal chromosome 21 aneuploidy
      
Biospecimen description: 
      Whole blood specimens will be collected and processed to plasma. DNA will be extracted from
      the plasma.
A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled
      lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment
      of inflammation will be via sputum induction.
    

Detailed description: 
      Methodology Validation
    

Intervention name(s): Fluticasone Propionate; Placebo for Fluticasone Propionate
Intervention type(s): Drug; Drug
Intervention description(s): Dry powder for inhalation, Single Dose, 500mcg; Dry powder for inhalation, Single Dose, placebo
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: COPD
Trial of IV NTG for CD After Second Stage Arrest for the Prevention of Uterine Extension
Condition: Prolonged Second Stage of Labor
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized controlled clinical trial of IV nitroglycerin at cesarean delivery for second
      stage arrest of descent to prevent or uterine extension at the hysterectomy site.
    

Detailed description: 
      Intravenous nitroglycerin resulting in uterine relaxation has been standardly utilized for
      various obstetrics conditions, e.g. breech extraction of second twin in vaginal deliveries,
      uterine relaxation after tachysystole in labor, prior to external cephalic version, and
      during difficult fetal extraction during cesarean delivery for arrest of descent in labor.
      Currently the use of nitroglycerin is at equipoise in obstetrics for difficult cesarean
      delivery after second stage arrest in labor. The clinical trial will randomize women who
      undergo cesarean delivery for second stage arrest in labor to receive IV nitroglycerin vs
      saline at the time of hysterotomy. The primary outcomes will be maternal: uterine extension,
      blood loss, total fetal extraction time, surgical time; neonatal: cord gases at delivery,
      apgar scores, admission to neonatal intensive care unit.
    

Intervention name(s): intravenous nitroglycerin
Intervention type(s): Drug
Intervention description(s): Infusion at started at time of hysterotomy and stopped at neonate delivery
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
JAK-inhibition in Recurrent Classical Hodgkin Lymphoma
Condition: Recurrent Classical Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The Purpose of this trial is:

        -  to determine the overall response rate (ORR, complete response [CR] + partial response
           [PR]) in patients with relapsed or refractory HL

        -  to determine the safety profile of ruxolitinib in patients with relapsed or refractory
           HL
    


Intervention name(s): Ruxolitinib
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of the Effect of Propacetamol, Ibuprofen or Their Combination on Postoperative Pain and Quality of Recovery After Laparoscopic Hernia Repair in Children
Condition: Inguinal Hernia
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      There are difficulties in the progress of the study and cancel the plan. The purpose of this
      study is to evaluate the postoperative pain control using non - opioidal analgesics in
      children. The investigators will investigate the effect of single use and combination of
      caldorol(ibuprofen) compare to denogan(propacetamol) in children.

      Participants who receive the laparoscopic inguinal hernia repair between 6 months and 6 years
      old are divided 3 groups(caldolor, denogan, combination). Each groups are received a
      medication by protocol during surgery. After operation patient's pain score and use of
      additional analgesics are recorded in postanesthesia care unit and general ward.
    


Intervention name(s): ibuprofen (caldolor 10 mg / kg); propacetamol (denogan 30 mg / kg); ibuprofen + propacetamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dilution caldolor 10 mg / kg in Hartmann solution to 50 mL - 100 mL and intravenous injection for 30 minutes immediately after induction of anesthesia; Dilution denogan 30 mg / kg in the dissolved solution to a total of 10 ml and intravenous injection for 10 minutes after the main surgical procedure end; Dilution caldolor 10 mg / kg in Hartmann solution to 50 mL - 100 mL and intravenous injection for 30 minutes immediately after induction of anesthesia Dilution denogan 30 mg / kg in the dissolved solution to a total of 10 ml and intravenous injection for 10 minutes after the main surgical procedure end
Intervention MeSH terms: Acetaminophen; Ibuprofen; Propacetamol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants are divided 3 groups(caldolor, denogan, combination group) randomly. Each groups are received a medication by protocol during surgery
Masking: Single (Participant)
Primary purpose: Treatment
Interaction Between Antihypertensives and Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      NSAIDs may increase blood pressure and blunt the effects of many antihypertensives. Members
      of these drug classes differ in their propensity to such an interaction.
    

Detailed description: 
      To compare prospectively the effects of piroxicam, ibuprofen and acetaminophen on blood
      pressure control in hypertensive patients with osteoarthritis.
    

Intervention name(s): acetaminophen; ibuprofen; piroxicam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os; acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os; acetaminophen 1000 mg t.i.d. per os ibuprofen 400-600 mg t.i.d. per os piroxicam 10-20 mg o.d. per os
Other intervention name(s): paracetamol
Intervention MeSH terms: Acetaminophen; Ibuprofen; Piroxicam
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: antihypertensive drugs; non-steroidal anti-inflammatory drugs; interaction; family practice; arterial blood pressure
Effects of Sucrose Added Blind to the Diet Over Eight Weeks on Body Mass and Weight in Men
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Background: Sugar intake, especially in liquid, correlates with obesity. Yet, whether it is a
      special cause of obesity is less clear. Few experimental studies exist.

      Aim: To replicate the investigators' previous 4 week experiments on women with men over 8
      weeks to ascertain if: they gain weight given sucrose soft drinks; mood is affected; energy
      intake is affected.

      Participants: 80 men BMI 25-35, aged 30-55. Procedure: After a week of baseline, over eight
      weeks single blind 40 men received soft drinks containing sucrose (1650 KJ, 97g carbohydrate
      per day), 40 received control drinks. A three-day food diary with mood ratings and activity
      levels was completed during baseline and weeks 1, 4 and 8 of the experiment. Body mass was
      recorded weekly with other anthropometric measures.
    


Intervention name(s): Sucrose
Intervention type(s): Dietary Supplement
Intervention description(s): Sucrose sweetened soft drinks
Other intervention name(s): Aspartame; Aspartame sweetened soft drinks as comparator
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Sucrose; Sugar; Carbohydrate; Weight gain; men
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
Condition: Upper Gastrointestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      The objective of the investigation is to evaluate the feasibility of detecting blood in
      healthy volunteers after ingestion of autologous blood mixed with water.
    

Detailed description: 
      A total of 10 healthy volunteers were recruited to undergo a testing procedure. Subjects were
      instructed to ingest the PillSense Capsule with 100mL of water. The position of the capsule
      in the stomach was verified by fluoroscopy. Subjects were then asked to sequentially drink
      (every 5min) 2 mixtures containing 25mL of water and 25mL of their own blood obtained from a
      peripheral vein. The PillSense result ("blood detected" or " blood not detected") was
      recorded on Clinical Report Form after 5 minutes from capsule ingestion and after 5 minutes
      from the ingestion of both mixtures containing blood.

      Subjects were followed-up for capsule passing.
    

Intervention name(s): PillSense System
Intervention type(s): Device
Intervention description(s): The device is composed of an orally ingested PillSense capsule and a wireless handheld PillSense receiver for real-time display of sensor data. The capsule contains an optical sensor for in-vivo detection of blood. The sensor capsule is used for diagnosis in patients with suspected acute bleeding in the upper gastrointestinal tract.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth
Condition: Depression; Adolescent
MeSH terms: Depression
Study type: Interventional

Summary: 
      The aims of this study are to (1) identify inflammatory/neurotrophic and neurodevelopmental
      markers that predict antidepressant response and suicidal risk in depressed youth and (2)
      predict their treatment response and the occurrence of suicidal events at the individual
      level using machine learning approach.
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Depression; Adolescent; Biomarker; Inflammation; Brain-derived neurotrophic factor (BDNF); Functional MRI; Antidepressant; Machine learning
Sun Protection Factor Assay (SPF Assay 207/2016)
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987521
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
(Formulation Code:Z09-067)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Acupuncture in Fibromyalgia
Condition: Fibromyalgia; Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      Fibromyalgia is the second most common rheumatic disorder, affecting approximately 8-10
      million persons in the U.S., and is characterized by widespread musculoskeletal pain and soft
      tissue tenderness upon examination. This study focuses on the use of acupuncture as a mode of
      therapy for fibromyalgia. The issues under examination are: 1) the optimal duration of
      treatment, 2) the independent and synergistic effects of needle placement and needle
      stimulation, and 3) appropriate control strategies. The proposal utilizes a randomized,
      blinded, sham-controlled design to achieve these aims. Subjects are randomly assigned to one
      of four groups: 1)active site with stimulation, 2) active site, without stimulation, 3) sham
      site with stimulation, and 4) sham site, without stimulation. All subjects will receive
      acupuncture at escalating frequency, beginning at once per week and ending at 3 times per
      week. This "forced titration" design allows for the detection of inter-subject differences in
      responsiveness to acupuncture, as well as the factors which may predict responsiveness (or
      lack thereof). Secondary goals of the study are to collect data on the mechanism, safety, and
      cost-effectiveness of acupuncture in fibromyalgia, and to determine the optimal outcome
      measures, for a full scale research clinical trial.
    


Intervention name(s): Acupuncture
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: acupuncture; fibromyalgia; pain; analgesia
The Role of Contrast Enhanced Ultrasound in Appendicitis
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study seeks to determine the efficacy of Contrast Enhanced Ultrasound (CEUS) in
      improving the diagnosis of acute appendicitis in children, when compared to the standard
      grey-scale ultrasound.
    

Detailed description: 
      This will be a single-center, non-randomized trial that will add to our institution's current
      diagnostic algorithm using Contrast Enhanced Ultra Sound (CEUS) in subjects who are
      clinically suspicious for acute appendicitis.

      For those who consent to study participation, we propose obtaining a CEUS after the initial
      gray-scale ultrasound. Once the initial ultrasound is complete, the contrast Lumason® (sulfur
      hexafluoride lipid type-A microspheres) will be administered through an already existing IV
      catheter and an abdominal scan will be completed. The patient will then continue with
      standard of care treatment per his treating physician. The CEUS image will be read at a
      future time by a Children's Mercy Hospital radiologist blinded to the results of the gray
      scale ultrasound and computed tomography (CT) scan if one was obtained; these will be used
      for comparison.
    

Intervention name(s): Sulfur hexafluoride lipid-type A microspheres
Intervention type(s): Drug
Intervention description(s): Contrast Enhanced Ultrasound of the appendix
Other intervention name(s): Lumason
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluation of a Neck Strengthening Program to Reduce the Risk of Sport-related Concussion
Condition: Sport-related Concussion; Brain Concussion; Healthy
MeSH terms: Brain Concussion
Study type: Interventional

Summary: 
      Evaluation of a neck strengthening program as a potential intervention to reduce the risk of
      sport-related concussion in youth contact and collision sport athletes.
    

Detailed description: 
      This is a pilot study to investigate the effect of a supervised 8 week strengthening
      intervention in male and female youth contact and collision sport athletes. Participants will
      complete a supervised strengthening exercise intervention involving manual resistance
      exercises administered by a strength coach with pre- and post-intervention assessments of
      neck size and strength.
    

Intervention name(s): Neck Strengthening
Intervention type(s): Other
Intervention description(s): Targeted neck strengthening exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Concussion; Contact sport; Collision sport; Neck strengthening