bioihbjkbjnl/mcl2 huggingface dataset:
Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
Condition: Esophagitis
MeSH terms: Deglutition Disorders; Esophagitis; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      This is a prospective descriptive cross sectional study to determine the percentage of
      patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and
      to establish which presenting factors warrant esophageal biopsies. We hypothesize that a
      greater than expected percentage of patients who are biopsies will have histologic changes
      consistent with EE.
    

Detailed description: 
      All patients presenting with dysphagia who do not already carry a previous diagnosis for
      their dysphagia will be asked to enroll. If patients have undergone previous work up for
      dysphagia such as manometry, 24-hour probe, or barium swallow they can still participate in
      this study. Informed consent will take place prior to enrollment. After patients present with
      dysphagia they will fill-out a questionnaire regarding their dysphagia symptoms. An EGD with
      biopsies will then be performed. Biopsies will be taken from 4 quadrants in the proximal and
      distal esophagus. The distal esophagus biopsies will be taken 5 cm proximal to the Z-line.
      Proximal biopsies will be taken anywhere proximal to 30 cm from the incisors.
    

Intervention name(s): EGD with biopsies
Intervention type(s): Procedure
Intervention description(s): All subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus.
Other intervention name(s): Upper endoscopy
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients presenting with dysphagia will be eligibile for enrollment into the study.
      
Biospecimen description: 
      4 quadrant distal and proximal biopsies of the esophagus
    
Keywords: dysphagia; eosinophilic esophagitis
Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, multicenter, open-label study to evaluate the safety and tolerability of
      optimized doses of NBI-98854 administered once daily for 24 weeks in pediatric subjects with
      Tourette Syndrome.
    


Intervention name(s): Valbenazine
Intervention type(s): Drug
Intervention description(s): vesicular monoamine transporter 2 (VMAT2) inhibitor
Other intervention name(s): NBI-98854
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Different Massages Tecniques on Chronic Pelvic Pain
Condition: Chronic Pelvic Pain Syndrome
MeSH terms: Pelvic Pain
Study type: Interventional

Summary: 
      The aim of this study is to investigate and compare the effectiveness of transverse friction
      and Thiele massage on pain, quality of life and sexual functions in female patients with
      chronic pelvic pain. The study will be performed on 20 female patients with pelvic floor
      muscle tenderness, who applied to the Urology Clinic in Istanbul and were diagnosed with
      chronic pelvic pain.
    


Intervention name(s): Thiele Massage; Transverse Friction Massage
Intervention type(s): Procedure; Procedure
Intervention description(s): Transvaginal Massage; Transvaginal Massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of COVID-19 DNA Vaccine (AG0302-COVID19)
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the safety and immunogenicity of AG0302-COVID19 in healthy adult
      volunteers.
    

Detailed description: 
      This is a Phase 1/2, single-center, randomized, open-label, non-controlled trial.
      Approximately 30 healthy volunteers, male or female, aged 20-65, will be randomized to one of
      the following three groups.

      Group A: Vaccination twice at 2-week intervals (n = 10) Group B: Vaccination twice at 4-week
      intervals (n = 10) Group C: Vaccination 3 times at 2-week intervals (n = 10)
    

Intervention name(s): AG0302-COVID19; AG0302-COVID19; AG0302-COVID19
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2.0 mg of AG0302-COVID19 twice at 2-week intervals; 2.0 mg of AG0302-COVID19 twice at 4-week intervals; 2.0 mg of AG0302-COVID19 three times at 2-week intervals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; COVID-19; SARS-CoV-2
Coherence Between Brain Cortical Function and Neurocognitive Performance During Changed Gravity Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      Alongside a well-known physiological deconditioning, such as a decrease in muscle mass or
      bone demineralization, extended stays in weightlessness also cause cognitive dysfunction.
      However, the studies on this subject during space missions short or long term could not
      determine how these cognitive dysfunction resulted from a direct effect of weightlessness or
      a stress-related effect.

      Analysis of electro-encephalography (EEG) using a standardized mapping method is used to
      study the changes of operation of the cerebral cortex as the near infrared spectroscopy
      (NIRS) is a reflection of changes in the cerebral hemodynamics. Their combined use is a
      relatively simple and economical method for studying brain changes in an environment where
      the normal brain imaging techniques can not be used.

      The main objective of this experiment is to evaluate the alterations in brain cortical
      activity and brain oxygenation level induced by micro- and hypergravity conditions.
    


Intervention name(s): Parabolic flight; EEG measurement; NIRS measurements
Intervention type(s): Other; Other; Other
Intervention description(s): Electro cortical power in alpha frequency ranges (EEG-LORETA); Brain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) - NIRS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: volunteers
The Efficacy and Safety of Curcuma Domestica Extracts and Ibuprofen in Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Osteoarthritis of knee is common degenerative musculoskeletal diseases. Non-steroidal
      antiinflammatory drugs (NSAIDs) are used to decrease pain symptom but someone can not
      tolerate its gastrointestinal adverse effects. In vitro studies showed that curcumin had an
      inhibitory effect on substances playing an important role in inflammatory pathway. The
      mechanisms by which curcumin prevents inflammation are postulated through inhibition of many
      cytokines, for example, lipo-oxygenase, cyclo-oxygenase, and phospholipase. Therefore, if
      curcumin is effective as NSAIDs with less side effects, it can be an alternative treatment
      for those OA knee patients.
    

Detailed description: 
      Curcumin was demonstrated to be safe and had anti-inflammatory activity in six studies in
      humans. It may exert its anti-inflammatory activity by inhibition of a number of different
      molecules that play a role in inflammation.

      Our experience in a study of 100 subjects revealed a trend towards a greater effect in OA
      patients receiving Curcuma domestica extracts. However, studies with adequate sample and
      dosage of Ibuprofen are recommended to demonstrate the efficacy of C.domestica extracts in
      alleviating knee pain and improving knee functions.

      The objective of the study was to determine the efficacy and safety of C.domestica extracts
      in pain reduction and functional improvement in patients with knee osteoarthritis.
    

Intervention name(s): Curcuma domestica extracts; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): 1,500 mg per day (oral)divided into 3 times for 28 days; 1,200 mg/days (oral) divided into 3 times for 28 days
Other intervention name(s): Curcumin; Brufen
Intervention MeSH terms: Ibuprofen; Curcumin; Turmeric extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis, Knee, Curcumin, Multicenter, RCT
Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube
Condition: Pancreatitis
MeSH terms: Pancreatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the effect of erythromycin on the Rate of Success in
      Placement of a Self-propelled Feeding Tube.
    


Intervention name(s): Erythromycin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects receive 4x250mg erythromycin i.v. daily after intubation of a self-propelled feeding tube; Subjects receive 4x placebo i.v. daily after intubation of a self-propelled feeding tube
Intervention MeSH terms: Erythromycin; Erythromycin Estolate; Erythromycin Ethylsuccinate; Erythromycin stearate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: erythromycin; prokinetics; nasojejunal tubes; Bengmark feeding tube; post-pyloric feeding; pancreatitis; Non-critically ill patients having pancreatitis who require jejunal enteral nutrition
Body Composition and Risk for Development of Pre-diabetes in Post-menopausal Chinese Women in Singapore
Condition: Osteoporosis; Metabolic Syndrome
MeSH terms: Osteoporosis; Metabolic Syndrome; Prediabetic State
Study type: Observational

Summary: 
      This project aims to ascertain that novel imaging and metabolic markers can be used to
      identify as well as to validate and improve the detection of Singapore-Chinese women at
      increased risk of diabetes.
    

Detailed description: 
      Disproportionate non-communicable disease risk present in some ethnicities has been
      demonstrated and is amplified by increased weight gain. Relative to Malay and Caucasian
      populations, the prevalence of obesity increased sharply in people of Chinese and Indian
      ethnicity and diabetes risk is prevalent at a BMI of 21 (equivalent to a BMI >25 in Caucasian
      populations). It was also speculated that Chinese Singaporean women are prone to metabolic
      syndrome at a lower BMI. This study will recruit two groups of postmenopausal women with
      different BMI's and to measure markers for metabolic syndrome. These participants will visit
      Clinical Nutrition Research Centre for a single session and will undergo a whole body scan
      and a regional scan of the lumbar spine and femoral neck with a bone densitometer and fasting
      baseline blood and urine samples collected. Dual Energy X-ray Absorptiometry (DEXA) scan will
      provide percentage fat mass, fat in gram, whole body bone mineral content and total body lean
      mass. From these, gynoid and android fat distribution will be derived and appendicular lean
      mass will be calculated and an index calculated using kg/m2 to give an indication of relative
      muscle mass. In addition blood and urine samples will be collected for metabolic risk
      analysis. Participants will be also be undergoing a Quantitative Computed Tomography (QCT)
      scan which will allow true volumetric measurements of the lumbar spine and proximal femur
      independent of the body size. Volumetric density values will be measured in Hounsfield units
      transformed into Bone Mineral Density measurements using a calibration phantom underneath the
      patient. Magnetic Resonance Imaging of the 3rd lumbar vertebra and the right hip will also be
      performed.
    

Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Post menopausal women
Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of carbamazepine on
      single- dose tepotinib pharmacokinetics in healthy participants. Study details include: Study
      Duration: up to about 10 weeks; Treatment Duration: single dose of tepotinib on Days 1 and
      26, 25 days of treatment with carbamazepine (Days 8 to 32); Visit Frequency: residence in the
      Clinical Research Unit from Days -1 to 4 and Days 25 to 29, ambulatory daily visits from Days
      5 to 24 and 30 to 33, and one ambulatory visit on Day 39.
    


Intervention name(s): Tepotinib Hydrochloride Hydrate; Carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive Tepotinib hydrochloride hydrate film-coated tablet once daily with food on Day 1 and Day 26 in the morning.; Participants will receive Carbamazepine tablet with break-line twice daily at the same time each day in the morning and evening from Day 8 to Day 32.
Intervention MeSH terms: Tepotinib; Carbamazepine
Intervention model: Sequential Assignment
Intervention model description: This is a single sequence cross-over trial.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Clinical pharmacology; Metabolite; Induction of metabolism
Role of Oral Chlorhexidine Gel in Prevention of Ventilator Associated Pneumonia
Condition: Ventilator Associated Pneumonia
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if oral mucosal application of chlorhexidine gel
      will prevent the development of ventilator associated pneumonia in children.
    

Detailed description: 
      Ventilator associated pneumonia as the name suggests refers to pneumonia occurring in the
      setting of mechanical ventilation. It accounts of 86% of nosocomial pneumonia and in contrast
      to other more common nosocomial infections is accompanied by a mortality rate of upto 76% in
      certain settings. A number of preventive methods have been studied to reduce the rate of VAP
      but a consensus is lacking with regards to appropriate preventive strategies. Studies in
      adults have shown a beneficial effect of oral mucosal application of chlorhexidine but
      similar studies in pediatric population are not available. This research project aims at
      addressing the gap.
    

Intervention name(s): Chlorhexidine gel; Placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): Oral mucosal application of chlorhexidine gel; Oral mucosal application of placebo gel
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
A Bioequivalence Study Of 80 Mg Atorvastatin Calcium Tablets Versus 80 Mg Lipitor® Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assessed the relative bioavailability of 80 mg Atorvastatin Calcium Tablets
      (containing atorvastatin calcium equivalent to 80 mg atorvastatin) manufactured by OHM
      Laboratories, Inc., USA (A subsidiary of Ranbaxy Pharmaceuticals., USA) compared to that of
      80 mg LIPITOR® Tablets (containing atorvastatin calcium equivalent to 80 mg atorvastatin)
      distributed by Parke Davis, Division of Pfizer Inc., USA following a single oral dose (1 x 80
      mg tablet) in healthy adult subjects when administered under fed conditions.
    

Detailed description: 
      This was an open-label, balanced, randomized, two-period, two-treatment, two-sequence,
      single-dose crossover bioequivalence study under fed conditions. The total duration of the
      study, screening through study exit, was approximately 8 weeks with at least a 14-day washout
      period between doses. At study check-in, the subjects reported to the clinical site at least
      36 hours prior to Day 1 dosing and were required to stay for 24 hours after Day 1 dosing.
      Blood sample collections were obtained within 90 minutes prior to dosing (0 hour) and after
      dose administration at 0.333, 0.667, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.5, 4, 6, 8,
      10, 12, 16, 24, 36, 48, 60, 72, and 96 hours. A total of 25 blood samples were collected per
      study period for a total of 50 samples or 150 mL total volume.
    

Intervention name(s): Atorvastatin
Intervention type(s): Drug
Intervention description(s): 80 Mg tablets
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents
Condition: Allergic Reactions
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to characterize the pharmacokinetic (PK) profile of
      brompheniramine maleate (BROM) in children and adolescents, ages 2 to less than 18 years
      following dosing in accordance with current weight-age dosing guidelines. Once characterized,
      the PK data will be pooled with adult PK data from other studies and analyzed under a
      separate analysis plan to confirm or refine the existing OTC doses in children aged 2 to <12
      yrs and adolescents aged 12 to <18 yrs.
    


Intervention name(s): Brompheniramine maleate
Intervention type(s): Drug
Intervention MeSH terms: Brompheniramine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users
Condition: Healthy; Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the abuse potential of single doses of pitolisant
      relative to phentermine HCl and placebo, when administered to healthy, non-dependent,
      recreational stimulant users.
    


Intervention name(s): Pitolisant; Placebos; Phentermine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pitolisant 40 mg or 240 mg (tablets over-capsuled); tablets over-capsuled; Phentermine 60 mg (capsule over-capsuled)
Other intervention name(s): BF2.649
Intervention MeSH terms: Phentermine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
Condition: Type 1 Diabetes Mellitus; Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with
      an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
    

Detailed description: 
      The study is a multi-center, prospective, single-sample correlational design without
      controls. The purpose of this study is to demonstrate the performance of the Guardian™ Sensor
      (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7
      days).
    

Intervention name(s): Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter
Intervention type(s): Device
Intervention description(s): Continuous Glucose Monitoring and frequent sample testing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Treatment Efficacy for Drug Abuse and AIDS Prevention - 1
Condition: Cocaine-Related Disorders; Heroin Dependence
MeSH terms: Substance-Related Disorders; Cocaine-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and effectiveness of buprenorphine for
      treatment of concurrent intravenous heroin and cocaine dependence.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Primary purpose: Treatment
Keywords: opioid addiction; cocaine addiction
Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for
      treatment of EDS in PD patients.
    

Detailed description: 
      This is a multi-center, open-label, single-arm 8-week investigation of Selegiline. Subjects
      who have a diagnosis of PD based on UK brain bank criteria with ESS> 7 will be received
      Selegiline as an adjunctive therapy or monotherapy. This study will assess the impact of
      Selegiline treatment on the severity of sleep disturbances among PD patients.
    

Intervention name(s): Selegiline
Intervention type(s): Drug
Intervention description(s): Subjects will receive one Selegiline tablet (5 mg) per day administered at breakfast. The initial dose of Selegiline is 5 mg/day and be up-titrated in 2-week intervals in increments of 5 mg up to 10 mg (which can be taken at breakfast or divided doses of 5 mg each taken at breakfast and lunch) according to the investigator's judgment, based on individual clinical response and tolerability.
Other intervention name(s): ELDEPRYL
Intervention MeSH terms: Selegiline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment