bioihbjkbjnl/mcl2 huggingface dataset:
An Open-Label, Randomized, Comparative 3-Way Cross-Over Study to Evaluate the Effect of Food on the 24-Hour Intragastric pH at Day 5 After Twice Daily Oral Administration of PN 200 (Omeprazole/Naproxen) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH
      (percent time pH> 4.0) following twice daily administration at different dosing times
      relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5.
    

Detailed description: 
      This study is designed to evaluate the effect of different dosing times of PN 200 relative to
      food on the intragastric pH profile of PN 200. PN 200 contains immediate release omeprazole,
      which may be subject to acid degradation in the stomach. Food is known to have a buffering
      effect on acid and therefore may result in less degradation of immediate release omeprazole.
      Alternatively, food may decrease the absorption of omeprazole in the duodenum. The relative
      magnitude of these effects is unknown. The data from this study will aid in choosing the
      optimal timing of PN dosing relative to food in future studies. The study is not blinded
      because the primary endpoint (intragastric pH) is a physiological variable not believed to be
      readily influenced by conscious or subconscious subject control.
    

Intervention name(s): PN 200
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy adults; Phase I
A Single Preoperative Dose of Gabapentin to Decreases Postoperative Pain in Ambulatory Anal Surgeries
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Single dose 600 mg gabapentin will be given preoperatively in anal surgeries
    

Detailed description: 
      Patients will be grouped into 2 groups of 25 patients each, the first group will receive 600
      mg of gabapentin one hour before surgery and the second group will receive a placebo tablet.
      pain scores will be measured postoperatively
    

Intervention name(s): Gabapentin
Intervention type(s): Drug
Intervention description(s): single preoperative dose of 600 mg gabapentin
Other intervention name(s): Gaptin 600 mg
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups are included in the study
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: anal surgery,; gabapentin,; postoperative pain
Medial Cervical Block for Carotid Endarterectomy Comparison With Standard Method
Condition: Cervical Plexus Block Comparison
Study type: Interventional

Summary: 
      The purpose of the study is to compare efficacy, complications and safety of the standard
      method of Combined (superficial and deep) cervical plexus block (SDCPB) with Ultrasound
      guided Medial Cervical plexus block technique (MCPB).

      Hypothesis: Ultrasound assisted MCPB is safer than SDCPB with similar efficacy.
    


Intervention name(s): cervical block
Intervention type(s): Procedure
Intervention description(s): In brief, the superficial block was performed using a 22G needle (07 x 40 mm). The mixture injected was 15 ml of 0.5% bupivacaine + 10 ml of 1% lidocaine. Deep cervical plexus block was performed using a Stimuplex DR stimulating needle and the dose of anaesthetic used was 10 ml 0.5% bupivacaine + 5 ml 1% lidocaine applied in the vicinity of the C3 nerve root.
The MCPB performed using ultrasound-guidance aiming specifically for the interfascia space. Eighteen ml of 0.375% bupivacaine was injected into the interfascia space at the level of C3 vertebral body using a 22G needle (07 x 40 mm).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Ultrasound; Cervical Plexus; Anesthesia, Conduction; Surgical Procedures, Elective; Atherectomy
Effect of C21 on Forearm Blood Flow
Condition: Study Vasodilatory Effects of C21
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of C21 on forearm blood flow by use of
      strain-gauge venous occlusion plethysmography.
    

Detailed description: 
      Subject will be screened for eligibility. Eligible subjects will receive ascending doses of
      C21 (3, 10, 30 and 100 µg/min through locla i.a. infusions for 5 min/dose. Forearm blood flow
      measurements will be performed in both arms during the last 2 minutes of each dose.

      infusions of sodium nitroprusside will be performed as a positive control using the same
      methodology.
    

Intervention name(s): C21; Sodium Nitroprusside
Intervention type(s): Drug; Drug
Intervention description(s): C21 in ascending doses of 15, 50, 150, 500 and 1000 µg; Ascending doses of 4, 8 and 16 µg
Other intervention name(s): Compund 21; Nipruss
Intervention MeSH terms: Nitroprusside
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Subjects will receive increasing doses of C21
Masking: None (Open Label)
Primary purpose: Screening
Efficacy and Safety of Unripe Bokbunja Extract on Improvement of Blood Cholesterol
Condition: Blood Cholesterol
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of unripe
      Bokbunja extract on improvement of blood cholesterol.
    

Detailed description: 
      This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Forty
      subjects were randomly divided into unripe Bokbunja extract 600 mg or placebo group. The
      investigators measured total cholesterol, lipid profile, arteriosclerosis index,
      anthropometric index, oxidized LDL.
    

Intervention name(s): unripe Bokbunja Extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): tablet(1 tablet/d, 600 mg/d) for 12 weeks; Placebo for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: cholesterol; Bokbunja; Clinical Trial
Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection
Condition: Chickenpox; Herpes Zoster
MeSH terms: Herpes Zoster; Chickenpox; Varicella Zoster Virus Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is
      usually a self-limiting illness characterized by fever and a rash. Serious complications can
      include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is
      not a standard of care in immunocompetent children, but is recommended whenever a risk of
      complication exists. This study will evaluate the safety and blood levels of a new
      formulation of famciclovir in children 1-12 years of age.
    


Intervention name(s): famciclovir
Intervention type(s): Drug
Intervention MeSH terms: Famciclovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chickenpox; herpes zoster; children; Famvir; varicella zoster virus
Study of Biomechanical Parameters of Unloading Braces Used in the Treatment of Knee Osteoarthritis (BIOoSE)
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Osteoarthritis is a chronic disease affecting millions of people worldwide, and knee is the
      second most affected site. Knee osteoarthritis is characterized by knee pain, loss of motion,
      disability, and muscle weakness, all factors contributing to gait alterations, and impacting
      greatly the patients quality of life. In the absence of curative treatment, pharmacological
      and non-pharmacological symptomatic treatments are prescribed to maintain this QoL, and
      therefore delay surgery to more appropriate window of opportunity later in life.

      The aim of the study was to investigate the acute effects of three braces, using different
      unloading strategies, on gait kinematic and kinetic parameters, as well as pain in patients
      with medial knee ostoeoarthritis.
    


Intervention name(s): Unloading brace; Rebel Reliever (RR); Action Reliever
Intervention type(s): Device; Device; Device
Intervention description(s): Participants underwent one session of gait analysis. The experimental protocol was divided in four conditions, the control condition without brace (NO), and then three conditions with the different braces tested in a randomized order.
For each condition, the participant was fitted with the brace by the same experimenter and equipped with 19/20 retro-reflective markers (without/with brace) on the pelvis and the investigated leg for motion analysis. After a short recording in a fixed standing position (static trial), each participant carried out at least three barefoot walking trials of a few meters long at a self-selected pace. The walking trial was validated if a complete gait cycle occurred on the two 90cm x 90 cm force plates recording the ground reaction forces. After each condition, the participant had to assess knee pain.; Rebel Reliever (RR) (Thuasne, Levallois Perret, France); Action Reliever (AR) (Thuasne, Levallois Perret, France)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, cross-over, open labelled, monocentric, controlled trial
Masking: None (Open Label)
Primary purpose: Treatment
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fed Male.
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      Two tamsulosin HClformulations will be tested in fed state
    


Intervention name(s): tamsulosin (Astellas); Tamsulosin HCL
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Aliskiren When Added to Standardized Losartan and Optimal Antihypertensive Therapy in Patients With Hypertension, Type 2 Diabetes and Proteinuria
Condition: Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Proteinuria; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Study of the efficacy and safety of aliskiren when added to losartan and optimal
      antihypertensive therapy in patients with hypertension, type 2 diabetes, and kidney disorders
      to monitor improvement in any of these conditions.
    


Intervention name(s): aliskiren
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Other
Keywords: diabetes; nephropathy; hypertension; aliskiren; losartan
Alfentanil: Simultaneous Testing Pilot
Condition: Evaluate Two Paradigms for Simultaneous Assessment of Hepatic and Intestinal CYP3A
Study type: Interventional

Summary: 
      To evaluate two paradigms for simultaneous assessment of hepatic and intestinal CYP3A
      activity.
    


Intervention name(s): Alfentanil
Intervention type(s): Drug
Intervention description(s): No drug treatment before alfentanil
Intervention MeSH terms: Alfentanil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Prospective 2-year Data Collection of the First 10 Patients After Ankle Spacer Implantation
Condition: Osteochondritis Dissecans
MeSH terms: Osteochondritis; Osteochondritis Dissecans
Study type: Observational

Summary: 
      Osteochondral defects (OCD) of the talus are pathologic lesions of the talar cartilage and
      its subchondral bone and might severely deteriorate the quality of life. For the treatment of
      multiple and/or large talar OCDs and in patients with failed previous surgical treatment the
      Ankle Spacer was developed. Six patients are included in a prospective clinical and
      radiological study with a follow-up of two years.
    

Detailed description: 
      One surgeon in the investigator's center implanted 10 Ankle Spacers between April 2018 and
      October 2020. The average age was 41.7 years (20 - 70 years). All patients get a standard
      followed-up at 6 weeks, 12 weeks. After the first four patients, all following patients are
      enrolled in a prospective study and where followed up after 1 and 2 years additionally. The
      American Orthopaedic Foot and Ankle Society (AOFAS) Score, the Foot and Ankle Outcome Score
      (FAOS), the European Foot and Ankle Score (EFAS), the Visual Analogue Scale (VAS) for pain
      are collected. Radiographic parameters such as implant loosening, cystic changes,
      lateral/medial prominence of the implant, congruency to the talar rounding, progression of
      osteoarthritis or bone ware of the tibia plafond are recorded. The Ankle Spacer is a
      one-piece implant system that replaces the articulating upper talus surface of the
      tibio-talar joint, and offers several implant sizes in order to fit to the different talus
      sizes. It is anatomically designed to the native upper talus surface to provide an optimal
      fit to the distal articular surface. It has a rough titanium plasma spray (TPS) coated under
      surface with two posts and spikes for implant fixation. The rough surface enables secondary
      fixation by means of bone ingrowth and the spikes at the posterior part of the prosthesis
      allowing for optimal adherence of the implant and for minimal iatrogenic damage upon
      fixation. By these means, the anatomical situation and the natural congruency of the ankle
      joint are mirrored to an optimal extent.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The average age is 41.7 years (20 - 70 years). Patients with multiple and/or large talar
        osteochondral defects (OCD) and patients with failed previous surgical treatment for OCD or
        osteoarthritis of the talus with up to grade two (Kellgren-Lawrence-Score) osteoarthritis
        on the tibial site are included.
      
Keywords: Osteochondral defects (OCD) of the talus; Ankle Spacer; osteoarthritis of the ankle joint
GLS-5700 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The clinical trial will assess the safety, tolerability, and immunogenicity of GLS-5700.
      GLS-5700 is a synthetic DNA plasmid vaccine against the Zika virus. ZIKA-001 is the first in
      man clinical trial of this vaccine which encodes for the premembrane-membrane and envelope
      regions of Zika virus.

      Zika virus, first discovered in the Zika forest in 1947, has caused a large epidemic in South
      America, Central America, and the Caribbean islands commencing in late 2014 or early 2015.
      Zika virus can cause significant neurologic disease to include Guillain Barre Syndrome in
      adults and microcephaly and other birth defects among children born to mothers who are
      infected during pregnancy. At present no vaccines or treatments have been approved for Zika
      virus infection.
    

Detailed description: 
      GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope
      (prME) proteins of the Zika virus.
    

Intervention name(s): GLS-5700
Intervention type(s): Biological
Intervention description(s): GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Zika; Vaccine; DNA
Optimization of Blood Levels of 25(OH)-Vitamin D in African Americans
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Two-thirds of the US population, particularly African Americans (AA), is at risk for
      inadequate or deficient 25-hydroxy-vitamin D (25(OH)VD). Epidemiological studies demonstrate
      an association between better health outcomes and higher blood levels of 25(OH)VD .
      Randomized controlled clinical trials have shown that, while supraphysiological high doses of
      VD are needed to achieve adequate blood levels of 25(OH)VD, not all subjects respond to them.
      Recent studies have also questioned the therapeutic effects of high-dose VD supplementation.
      Severe VD deficiency has been associated independently with the future risk of mild cognitive
      impairment (MCI) and dementia. A reduction in GSH and an increase in the oxidative stress
      levels of serum, erythrocytes, and circulating lymphocytes has been observed in MCI and
      Alzheimer disease, findings similar to those in VD deficient persons. Scholarly reviews
      conclude that excess oxidative stress is one of the major risk factors for AD and support a
      potential therapeutic role for L-cysteine (LC, a GSH precursor) and vitamin D (VD)
      supplementation in the treatment of Alzheimer disease symptoms. This application presents the
      investigators' design for a randomized, double-blind, placebo-controlled clinical trial to
      test the hypothesis that supplementation with VD in combination with L-cysteine (LC) is more
      successful at optimizing the statuses of 25(OH)VD [biological signatures] and simultaneously
      decreasing TNF-α, IR [functional or clinical outcomes], and oxidative stress, suggesting a
      better therapeutic approach compared with supplementation with VD alone in AA subjects.
    


Intervention name(s): Vitamin D; Placebo; Vitamin D + L-cysteine; L-cysteine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules ingested orally; Capsule ingested orally; Capsule ingested orally; Capsule ingested orally
Other intervention name(s): cholecalciferol; starch; combination of vitamin D and L-cysteine; amino acid
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: African American;; Vitamin D;; Insulin resistance; Alzheimer's Disease
Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects
Condition: Dyspeptic Subjects
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multi-center, open-label comparison study and aimed to evaluate the
      preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying
      abnormal (delayed) gastric emptying rates in subjects.
    

Detailed description: 
      Approximately equal numbers of subjects will be enrolled in each of the 2 groups (with normal
      gastric emptying, and with delayed gastric emptying (gastroparesis)) to complete at least 10
      subjects per group.

      The subjects will first have their gastric emptying rates investigated by scintigraphy using
      the Solid Test Meal containing 500 uCi 99mTc sulfur colloid at Visit 1. Second, the subjects
      will have their gastric emptying rates investigated by scintigraphy and 13C-uracil GEBT
      simultaneously using the Semi solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100
      mg of 13C-uracil, respectively, at Visit 2. A comparison will be made between the results
      obtained at Visits 1 and 2 along with a comparison of the data obtained during Visit 2 for
      evaluation of the 13C-uracil GEBT.
    

Intervention name(s): 13C-uracil; 99mTc sulfur colloid
Intervention type(s): Drug; Drug
Intervention description(s): PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.; PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.
Other intervention name(s): C13-URA; Technetium Tc 99m Sulfur Colloid Injection
Intervention MeSH terms: Technetium Tc 99m Sulfur Colloid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Comparison of ThermaWedge™ Device and Achilles Tendon Stretching for the Treatment of Plantar Fasciopathy
Condition: Plantar Fasciitis; Plantar Fasciopathy
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      The investigators will compare Achilles tendon stretching with a new product called a
      ThermaWedge™ device, a foam wedge designed to help with certain foot stretches and exercises,
      in the treatment of chronic plantar fasciopathy. There will be 2 groups each of 25 - 30
      participants who have chronic plantar fasciopathy, which is a common cause of foot pain.
      Exercises will be done for 6 weeks and then each group will do the other exercise protocol
      for another 6 weeks. Participants will fill out the Foot and Ankle Disability Index scale and
      numerical analog pain scale and the Global Rating of Change Scale prior to any treatment,
      weekly during treatment and post treatment. The investigators' hypothesis is that use of the
      ThermaWedge™ device will result in decreased pain and disability when compared to achilles
      tendon stretching.
    


Intervention name(s): ThermaWedge TM; Achilles Tendon Stretching
Intervention type(s): Device; Other
Intervention description(s): ThermaWedge TM is a foam wedge device that is designed to be used in the treatment of plantar fasciopathy.; Participants will be asked to perform achilles tendon stretching exercises which will be demonstrated at the initial orientation.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ThermaWedge TM; stretches
Efficacy and Safety of Ginkgo Biloba in Middle-aged Cognitively Intact Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to assess the efficacy and safety of Gingko biloba
      film-coated tablets in improving cognitive function and neuropsychological functioning of
      middle-aged cognitively intact adults.
    


Intervention name(s): Gingko biloba; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment