bioihbjkbjnl/mcl2 huggingface dataset:
Exploration of the Biologic Basis for Underperformance of Oral Polio and Rotavirus Vaccines in INDIA (PROVIDE)
Condition: Poliomyelitis; Tropical Enteropathy
MeSH terms: Poliomyelitis; Intestinal Diseases; Sprue, Tropical
Study type: Interventional
Phase: Phase 1

Summary: 
      Oral polio and rotavirus vaccines are significantly less effective in children living in the
      developing world. Tropical enteropathy, which is associated with intestinal inflammation,
      decreased absorption and increased permeability, may contribute substantially to oral vaccine
      failure in developing country settings. Other possible causes of oral vaccine
      underperformance include malnutrition, interference with maternal or breast milk antibodies,
      changes in gut microbiota, and genetic susceptibility.The primary Objective of this study is
      to determine whether decreased vaccine responsiveness to oral poliovirus or rotavirus
      vaccines is associated with the presence of tropical enteropathy.
    

Detailed description: 
      Intervention of this study is to vaccinate oral poliovirus vaccine and oral rotavirus vaccine
      to the child with two group; with inactivated poliovirus vaccine and without inactivated
      poliovirus vaccine. Rotavirus vaccines give to the child at 10 weeks of age and 17 weeks of
      age.
    

Intervention name(s): IPV vaccination
Intervention type(s): Biological
Intervention description(s): Randomized IPV or OPV to children aged at 39weeks.
Other intervention name(s): Rotavirus vaccination to children at 10 and 17 weeks of age.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Keywords: Oral vaccines; Vaccine Responsiveness; Tropical Enteropathy
Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses in Healthy
Condition: Healthy Subjects; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerbility of ascending multiple
      oral doses of AGG-523 in healthy subjects and in subjects with osteoarthritis.
    


Intervention name(s): AGG-523
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Study Evaluating The Safety And Efficacy Of Varenicline and Bupropion For Smoking Cessation In Subjects With And Without A History Of Psychiatric Disorders
Condition: Smoking Cessation
MeSH terms: Mental Disorders; Problem Behavior
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to assess varenicline and bupropion as aids to smoking
      cessation treatment in subjects with and without an established diagnosis of major
      psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified
      adverse events (AEs) in both of these populations).
    


Intervention name(s): Placebo; varenicline tartrate; bupropion hydrochloride; Nicotine Replacement Therapy Patch
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Triple dummy placebo for each treatment arm; Subjects will be titrated to the full dose during the first week in the following manner: 0.5 mg (tablet form) once a day for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 11 weeks; Subjects will receive 150 mg (tablet form) once a day for 3 days and then will take 150 mg twice a day for the remainder of the treatment period (11 weeks and 4 days).; Subjects will start active dosing the morning of the Week 1 visit and will receive a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment.
Other intervention name(s): Chantix; Champix; NRT
Intervention MeSH terms: Bupropion; Nicotine; Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: smoking cessation; psychiatric disease
Randomized Trial Comparing Misoprostol and Foley Bulb for Labor Induction in the Preterm Gestation
Condition: Premature Birth; Cervical Ripening
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the time to delivery of two different cervical
      ripening methods on the preterm gestation.
    

Detailed description: 
      Labor induction for the preterm gestation is indicated for various maternal and fetal
      indications. The preterm cervix, however, is frequently not favorable for induction. Multiple
      methods have been evaluated in the term gestation. As these comparison studies have not
      included the preterm gestation, this study seeks to evaluate these two methods in terms of
      safety, efficacy and time to delivery.
    

Intervention name(s): Misoprostol; Foley bulb
Intervention type(s): Drug; Device
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Preterm gestation; Cervical ripening; Labor induction; Misoprostol; Foley bulb
Bioavailability Food-Effect Study of an Oral Nitisinone Formulation to Treat Hereditary Tyrosinemia (HT-1)
Condition: Hereditary Tyrosinemia, Type I
MeSH terms: Tyrosinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the bioavailability of the Test Product, Nitisinone
      10 mg Tablet, under fasting and fed conditions (food-effect).
    

Detailed description: 
      The specific aim is to conduct a randomized, single dose, two-period crossover
      bioavailability study in at least 16 healthy male and female subjects at a single study
      center to evaluate the in vivo performance of Test Product, Nitisinone 10 mg Tablet, under
      fasting and fed conditions.

      The study in healthy male and female volunteers is designed to establish a pharmacokinetic
      (PK) profile under fed and fasting conditions for the orally administered Test Product,
      Nitisinone 10 mg Tablets.

      A total of 20 healthy female and male volunteers (age 18 to 55 years old) will be entered
      into the study. Volunteers will be determined to be free of significant medical conditions as
      assessed by medical history, physical examination, and blood and urine tests. Volunteers will
      be randomly allocated to receive the Test Product under fasting or fed conditions.

      There will be a minimum 23 calendar days washout between treatments. Blood samples will be
      collected at pre-dose (0 hours) and at 15 minutes, 30 minutes, 1 hour, 2 hours, 2 hours and
      30 minutes, 3 hours, 3 hours and 30 minutes, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 10
      hours, 12 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours and 120 hours post-dose
      (total: 21 samples per treatment period).
    

Intervention name(s): Nitisinone
Intervention type(s): Drug
Intervention description(s): A single oral dose of Nitisinone 10 mg Tablet will be administered.
Intervention MeSH terms: Nitisinone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: HT-1; Tyrosinemia; Nitisinone; Bioavailability; Healthy Volunteer; Food-Effect
Study on the Effects of Exogenous Testosterone on Threat Perception and Behavioral Avoidance
Condition: Testosterone's Effects on Threat Perception/Response
Study type: Interventional

Summary: 
      The study aims to establish a clear causal link between testosterone and threat perception
      and behavioral responses to threat. Namely, the study focuses whether high levels of
      testosterone will cause an individual to exhibit increased physiological responses to threat
      (e.g., increased blood pressure, heart rate, and endocrine responses) and a decreased
      behavioral response (e.g., ignoring the threat, avoiding the threat, and postponing dealing
      with the threat). The threat in this study is a social threat involving public speaking, and
      is an outgrowth of previous research on the avoidance of health threats.
    

Detailed description: 
      Participants in the study will receive either a single dose of 10g 1% testosterone topical
      gel or placebo the day prior to participating in the study. The day of the study,
      participants will provide saliva samples throughout the study to track testosterone and
      cortisol levels. Participants will be asked to complete the Trier Social Stressor Task, which
      includes having to give a 5 minute speech to a panel of judges. Participants will be given
      the opportunity to postpone giving their speech to an unspecified date. The study will focus
      on two types of responses to the threat of public speaking: behavioral and physiological. The
      behavior of interest will be participants desire to postpone dealing with the threat (it is
      hypothesized that those in the testosterone administration group will have an increased
      desire to postpone). The physiological responses include increased levels of cortisol and
      increased cardiovascular tone (it is hypothesized that the testosterone administration group
      will show an increased physiological response compared to the placebo group).
    

Intervention name(s): Testosterone
Intervention type(s): Drug
Intervention description(s): Topical administration of testosterone gel. Participants receive a one-time, single dose of 10 g of 1% testosterone gel.
Other intervention name(s): AngroGel
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Testosterone; Social psychology; Human behavior
Tumor Necrosis Factor-alpha and Interleukin-18 Levels in Children With Gingivitis and Type 1 Diabetes Mellitus
Condition: Periodontal Diseases
MeSH terms: Gingivitis; Periodontal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Necrosis
Study type: Observational

Summary: 
      This study aimed to evaluate the levels of interleukin 18 and tumor necrosis factor-alpha
      (TNF-α) in gingival crevicular fluid (GCF) of children with type 1 diabetes mellitus and
      gingivitis.
    

Detailed description: 
      Eighty eight children (44 with type 1 diabetes mellitus and 44 healty; age range 7-14 years)
      will be recruited for the study. The children will be classified into four subgroups based on
      their periodontal status; 1) Children with gingivitis and diabetes mellitus (MG, n=22); 2)
      Children with type 1 diabetes mellitus with healthy periodontium (MH, n=22); 3)Healthy
      children with gingivitis (HG, n=22); 4) Healthy children with healthy periodontium (HH,
      n=22). Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be
      recorded. Interleukin-18 and TNF-α will be analyzed in GCF and saliva samples by ELISA.
    

Intervention name(s): ELISA
Intervention type(s): Diagnostic Test
Intervention description(s): Enzim linked immunoabsorbant assay
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        88 Children with diabetes mellitus and systemically healty children with and without
        gingivitis.
      
Biospecimen description: 
      Gingival crevicular fluid
    
Keywords: interleukin-18; gingival crevicular fluid; tumor necrosis factor alpha
A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy Volunteers
Condition: Healthy Volunteer, Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, multiple dose, parallel group study will assess the monoamine oxidase in the
      brain by in vivo positron emission tomography (PET) and safety of RO4602522 in patients with
      Alzheimer disease and in healthy volunteers. Patients and volunteers will receive multiple
      doses of RO4602522 and up to three injections of C11-L-deprenyl-D2 used in the PET.
    


Intervention name(s): 11C-L-deprenyl-D2; RO4602522; RO4602522
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous injection of 11C-L-deprenyl-D2 before positron emission tomography (PET); up to 3 injections in total; Multiple doses of RO4602522 for 14 days; Multiple doses of RO4602522 for up to 17 days
Intervention MeSH terms: Selegiline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sufentanil Bispectral Index Elderly
Condition: Loss of Consciousness
MeSH terms: Unconsciousness
Study type: Interventional

Summary: 
      We compared BIS values during propofol stepwise induction with or without concomitant
      sufentanil in patients ≥ 65 years .
    

Detailed description: 
      Bispectral index (BIS) is widely used to estimate the depth of anesthesia. In clinical
      studies, a large variability of BIS has been observed. Several factors may be responsible for
      this inconsistency. We were able to show that in elderly patients (average age 78 years)
      receiving increasing doses of propofol alone a BIS values at loss of consciousness (LOC) were
      about 30% higher compared with young patients (average age 35 years). We showed also that in
      young patients (average age 48 years) the BIS values at LOC were significantly higher in
      those receiving sufentanil concomitantly with propofol compared with those who had received
      propofol alone. It remains unknown, however, whether these data from young surgical patients
      are applicable to a population of elderly patients. It may be argued that in the elderly
      receiving propofol, the impact of advance age was so important that any addition of an opioid
      would not further disturb the sedation-monitor balance. Alternatively, it may be expected
      that in the elderly receiving an opioid added to propofol the impact of both drugs on
      sedation will be additive and that previous observations from younger patients will be
      further exaggerated. The impact of advance age and presence or absence of sufentanil during
      propofol induction on BIS values at LOC was investigated in this trial.
    

Intervention name(s): Sufentanil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): To evaluate, in the elderly, the impact of a concomitant administration of sufentanil during a step-wise propofol induction of anaesthesia on the depth of sedation measured using BIS and clinical sedation score.; To evaluate presence or absence of strong opioid (sufentanil) on BIS values in the elderly during propofol induction until the loss of consciousness
Intervention MeSH terms: Sufentanil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: BIS; Elderly; Propofol; Sufentanil; Loss of consciousness
Prospective Trial of Autologous Platelet Rich Plasma in Aortic Surgery
Condition: C.Surgical Procedure; Cardiac
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether autologous platelet rich plasma (APRP)is
      effective in reducing allogeneic blood transfusions during aortic surgery using deep
      hypothermic circulatory arrest.
    


Intervention name(s): Autologous Platelet-Rich Plasma Harvest Technique
Intervention type(s): Device
Intervention description(s): 15 to 20 mL/kg of whole blood is collected before the administration of heparin from a large-bore central venous access,and is separated into red blood cells component and autologous platelet-rich plasma component by an autologous transfusion system(Sorin Group Electa Essential; Sorin Group Italia, Milan, Italy).
Other intervention name(s): neutralizing heparin with protamine
Intervention MeSH terms: Heparin; Protamines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: autologous platelet rich plasma; deep hypothermic circulatory arrest; transfusion
Green Tea Extracts for the Prevention of Colorectal Adenomas and Colorectal Cancer
Condition: Neoplasms, Colorectal
MeSH terms: Colorectal Neoplasms; Adenoma
Study type: Interventional

Summary: 
      Experimental studies have shown the chemopreventive properties of green tea extract (GTE) on
      colorectal cancer. And colorectal adenomas are precursors to colorectal cancers. The aim of
      this study is to determine the preventive effect of GTE supplements on metachronous
      colorectal adenomas by giving GTE tablets of which are equivalent of 9 cup-of-green tea per
      day (0.9 g/day GTE, 0.6 g/day Epigallocatechin gallate (EGCG).
    

Detailed description: 
      The subjects who had undergone complete removal of colorectal adenomas by endoscopic
      polypectomy have been enrolled since June 2010. They were then randomized into two groups as
      follows: supplementation group (0.9 g GTE per day for 12 months) or control group without GTE
      supplementation. Follow-up colonoscopy was conducted in 12 months. A structured 72-h recall
      at baseline and the 1-year follow-up was used to assess dietary factors, and to evaluate
      rectal mucosal proliferation index (RMPI) using known proliferation markers (Ki-67/PCNA), at
      least 2 random biopsies of rectal mucosa were taken. A sample size of 176 patients (88 per
      each group) was calculated to give the study 80% power to detect a difference, assuming a
      two-sided significance test at the 0.05 level.
    

Intervention name(s): GTE (green tea extract)
Intervention type(s): Dietary Supplement
Intervention description(s): 6 GTE tablets per day. Daily dose is equivalent of 9 cup-of-green tea per day (0.9 g/day GTE, 0.6 g/day epigallocatechin gallate [EGCG]).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chemoprevention; Colorectal adenomatous polyp; Green tea extract
Pharmacological Study That Measures Omeprazole Effect on Aspirins Absorption in Healthy Volunteers
Condition: Aspirin Blood Level; Proton Pump Inhiditor Treatment
Study type: Interventional

Summary: 
      Aspirin is a weak acid that crosses the gastric and intestinal mucosa by passive diffusion
      while in its lipophilic nature.Omeprazole, a proton pump inhibitor, inhibits gastric acid
      secretion.

      We assumed that omeprazole inhibits aspirin absorption, thus reducing its action on
      platelets.

      healthy volunteers, with no known peptic disease or bleeding disorders will be enrolled.

      All volunteers will receive 7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin
      and Omeprazole 20mg twice daily for 3 days and then 20mg once daily.

      Blood levels of Aspirin will be determined by High performance liquid chromatography (HPLC),
      0, 1, 2, 4, 6, 10, 24 hours after the administration of Aspirin alone on day 7 and Aspirin
      plus Omeprazole on day 21.

      Platelet function tests will be determined by platelet-rich plasma aggregometry in response
      to Arachidonic acid (500mg/ml), Ristocetin (1.5mg/ml) and Adenosine 5'-diphosphate (20mM) on
      day 0 as baseline and on day 7 and 21 of the study.
    


Intervention name(s): aspirin and omeprazole
Intervention type(s): Drug
Intervention description(s): aspirin 100 mg, once daily aspirin 100 mg and omeprazole 20 mg both once daily.
Intervention MeSH terms: Aspirin; Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: pharmacokinetics; aspirin; proton pump inhiditor
Computerized Psychoeducation for Anxiety Sensitivity
Condition: Anxiety Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      This investigation examines the efficacy of a 35 minute computerized psychoeducation protocol
      in the reduction of elevated anxiety sensitivity cognitive concerns, a risk factor for the
      development and maintenance of various forms of psychopathology.
    


Intervention name(s): CAST psychoeducation; PHET
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Utilizing Text Messaging to Improve Vehicle Safety Among At-Risk Young Adults
Condition: Risk Reduction
Study type: Interventional

Summary: 
      The "Safe Vehicle Engagement (SaVE)" trials are 3 parallel randomized clinical trials that
      aim to determine the impact of text messaging (SMS) vehicle safety interventions vs. weekly
      SMS vehicle safety self-monitoring alone on seat belt use, distracted driving and drink
      driving among young adults identified in the emergency department (ED) with risky vehicle
      behaviors.
    

Detailed description: 
      The investigators propose to conduct 3 related randomized, controlled, parallel group,
      assessor-blind, superiority trials of 6-week text message interventions vs. SMS vehicle
      safety self-monitoring in young adult participants with risky vehicle behaviors. A total of
      500 adult participants will be enrolled: 300 into Cohort 1 (seat belt); 100 into Cohort 2
      (distracted driving); 100 into Cohort 3 (drink driving). Each SMS intervention will be
      designed to target a single risk behavior. The study is powered to show a difference of 15%
      in the percentage of subjects reporting seat belt use at week 8. Other cohort trials (i.e.
      distracted driving, drink driving) and outcomes will be exploratory.
    

Intervention name(s): SMS Dialogue; SMS Assessments
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Once-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support; Once-weekly SMS assessments of motor vehicle risks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, 2-arm (intervention vs. control)
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: text message; behavioral intervention; motor vehicle
Cell Proliferation in Pulmonary Hypertension. FDG-PET Comparison Between Patients and Healthy Subjects
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension
      (CTEPH) are serious diseases with poor prognosis despite recent advances. Currently,
      pulmonary hypertension (PH) is considered a cell proliferative disorder, which has not been
      adequately characterized due to the lack of markers. A better understanding of the mechanisms
      that regulate this proliferative disorder will allow the identification of new therapeutic
      targets for HP.

      The objective of the project is to identify cell proliferative processes in severe forms of
      PH. Patients with PAH (n=20), CTEPH (n=20) and healthy controls (n=20) will undergo
      characterization of microRNAs (miRNAs) contained within circulating microparticles (MPs)
      analysis and mitochondrial functionality and FDG-PET to compare cell metabolism in the lungs
      and the right ventricle between patients and controls.
    


Intervention name(s): fludeoxyglucose
Intervention type(s): Drug
Other intervention name(s): FDG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic