bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Using Medial Longitudinal Arch Supported Insoles on Jumping in Young Football Players
Condition: Pes Planus; Sports Physical Therapy
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      In this study, it was aimed to determine the effect of pressing styles and insoles on jumping
      performances.
    

Detailed description: 
      In this clinical study, 30 healthy male football players between the ages of 16-20 will be
      carried out at Kasımpaşa Sports Club Academy. In the study, the effect of medial longitudinal
      arch height and the use of insoles on jumping using vertical jump, countermovement jump and
      drop jump tests will be investigated. Football players; Medial longitudinal arch heights will
      be measured by applying Foot Posture Index-6 and Navicular Position Test. As a result of
      these measurements; flat sole, normal sole and high sole will be divided into three groups.
      These three groups; Vertical jumping, countermovement jumping and drop jumping tests will be
      applied with the help of portable jumping apparatus and the results will be recorded. These
      tests will be re-applied to all three groups with a non-personalized, prefabricated insole
      that supports the medial arch. According to these tests, it will be investigated whether
      jumping performance depends on medial arch height. It will be evaluated whether there is a
      change in jumps after the insoles used. The obtained data will be analyzed statistically.
    

Intervention name(s): insoles
Intervention type(s): Device
Intervention description(s): Insoles are support devices that take the shape of the foot structure and enable the foot to press in a correct form.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: use of insoles
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: jumping; insoles; footballer
Adacolumn in Refractory UC Patients Trial
Condition: Ulcerative Colitis, Active Moderate
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of the study are to observe and document the efficacy and safety of 5 or more
      Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of
      ulcerative colitis patients. The patient subset of interest is those with moderate/severe,
      steroid-dependent, active ulcerative colitis with insufficient response or intolerance to
      immunosuppressants and/or biological agents.
    


Intervention name(s): (GMA) Adsorptive Apheresis
Intervention type(s): Device
Intervention description(s): Patients will be treated with once-weekly Adacolumn® apheresis over 5 consecutive weeks; treatment can be extended to up to 10 treatments administered once weekly over 10 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of RO7239361 in Ambulatory Boys With Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled study to assess the
      efficacy, safety and tolerability of two different weekly doses of RO7239361 in ambulatory
      boys with Duchenne Muscular Dystrophy (DMD).
    


Intervention name(s): RO7239361; Placebo for RO7239361
Intervention type(s): Drug; Drug
Intervention description(s): Take RO7239361 subcutaneously on specified days over a 48 week blinded period; Take placebo subcutaneously on specified days over a 48 week blinded period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: muscular dystrophy; Duchenne's Muscular Dystrophy; DMD
Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification
Condition: Cystoid Macular Edema; Cataract
MeSH terms: Cataract; Macular Edema; Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4% and nepafenac
      0.1% eye drops for prophylaxis of cystoid macular edema (CME) after small-incision cataract
      extraction.
    

Detailed description: 
      This prospective randomized clinical trial study included patients older than 40 years with
      age-related cataract, and a normal ophthalmologic examination besides senile cataract.
      Exclusion criteria were previous ocular surgery, central endothelial cell count less than
      2000 cells/mm2, glaucoma or intraocular pressure greater than 21 mmHg, amblyopia, retinal
      abnormalities, steroid or immunosuppressive treatment, connective tissue diseases, or an
      allergy or hypersensitivity to NSAIDs. Enrolled patients who had complicated cataract surgery
      (eg, posterior capsule rupture, vitreous loss, or an intraocular lens not placed in the
      capsular bag) were subsequently excluded.

      Study Protocol Preoperatively, patients had an extensive ophthalmologic examination,
      including measurement of corrected distance visual acuity (CDVA), refraction, slitlamp
      examination, intraocular pressure (IOP), fundoscopy, corneal endothelial cell count by
      noncontact specular microscopy (Noncon Robo, Konan), central corneal thickness (CCT)
      measurement (Pentacam, Oculus, Inc.), and biometry with the IOLMaster partial coherence
      interferometry device (Carl Zeiss Meditec AG). The targeted postoperative refractive error
      was 0.0 D. The visual acuity measurements were recorded with logMAR UDVA and CDVA.

      In addition, a baseline spectral-domain OCT (SD-OCT) scan was performed before surgery and
      postoperatively after 1, 4 and 12 weeks. All SD-OCT imaging was performed with a
      spectral-domain Heidelberg Spectralis OCT devise (Heidelberg Engineering, Inc., Heidelberg,
      Germany).

      Patients were assigned in a 1:1 ration to 1 of 2 treatments groups using a computer-generated
      randomization list. The study medications were ketorolac tromethamine 0.4% (Acular LS,
      Allergan) in group 1, and nepafenac 0.1% (Nevanac, Alcon) in group 2. Patients were
      instructed to instill ketorolac tromethamine 0.4% 1 drop in the operative eye 4 times a day
      (breakfast, lunch, dinner, and before bedtime), and nepafenac 0.1% 1 drop 3 times a day.
    

Intervention name(s): Nepafenac; Ketorolac
Intervention type(s): Drug; Drug
Intervention description(s): One drop in the study eye 3 times daily for 30 days; One drop in the study eye 4 times daily for 30 days
Other intervention name(s): Nevanac; Acular LS
Intervention MeSH terms: Ketorolac; Nepafenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cystoid macular edema; nonsteroidal anti-inflammatory drug; OCT; phacoemulsification.
Effect of Aerobic Exercise on Blood Pressure Changes
Condition: Hypertension; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This study will evaluate the effect of an aerobic training program versus a strength training
      program on the autonomic nervous system at rest and in response to challenge.
    

Detailed description: 
      The purpose of this study is to compare the effectiveness of an aerobic exercise program
      versus a strength training program in altering RR interval and blood pressure variability as
      indices of autonomic nervous system regulation of the cardiovascular system. Subjects will be
      tested at rest and in response to challenge.

      This study will enroll healthy, young (age 18-45) sedentary individuals at Columbia
      University Medical Center and St. John's University. At an initial screening visit, potential
      participants will be screened for exercise activity and will also undergo a test of aerobic
      capacity. Subjects will be eligible if they are not exercising regularly and do not exceed
      American Heart Association standards for average fitness (VO2max ≤ 43 and 37 ml/kg/min for
      men and women respectively). Exclusion criteria include current symptoms of affective
      disorder, psychosis, or substance abuse, current usage of psychotropic medication, and any
      medical condition that affected the autonomic nervous system or cardiovascular system.

      Eligible participants will then be randomly assigned to 12 weeks of either an aerobic
      conditioning program or a strength training program. At study entry, heart rate, respiratory
      rate, and blood pressure will be measured; an ECG will be used to measure heart activity.
      Questionnaires will be completed to assess anger, tension, depression, and fatigue.
      Participants in the aerobic conditioning program will attend four 1-hour exercise sessions
      per week, which will focus on increasing cardiovascular fitness through running and other
      forms of aerobic exercise. The strength training program will also include four sessions per
      week, with the focus on increasing muscle endurance and strength. At the end of the 12-week
      programs, participants will begin a 4-week period of deconditioning, during which they will
      discontinue all exercise. Evaluations will be repeated at the end of the 12-week programs,
      and at the end of the 4-week deconditioning period.
    

Intervention name(s): Aerobic Conditioning Program; Strength Training Program
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Blood Pressure, High
Omnitram Pharmacokinetic and Analgesic Study Following CY2D6 Inhibition With Paroxetine In Healthy Volunteers
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the analgesic effect of Omnitram and tramadol during concurrent
      administration of paroxetine. Paroxetine administration is expected to diminish the analgesic
      effect of tramadol, but not Omnitram. Each participant will receive paroxetine before and
      during treatment with Omnitram, tramadol, and placebo.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled study to investigating the steady-state oral
      pharmacokinetics and hypoalgesic effects of overencapsulated: 20 mg Omnitram (2x10 mg
      tablets), 50 mg tramadol (1x50 mg Ultram tablet), and placebo in male and female subjects
      made CYP2D6 deficient by paroxetine coadministration.

      Sixty participants in normal health, 18 to 50 years of age, who meet the entry criteria, will
      be randomized to one of the three treatments in treatment segment 1. Each arm will ingest
      three consecutive 20 mg daily doses of paroxetine. Twelve hours after the first paroxetine
      dose, subjects will be randomized to one of the treatment sequences to ingest a total of 9
      doses of Omnitram, tramadol, or placebo (one dose every 6 hours). Immediately before the 9th
      dose a blood sample will be collected to quantify plasma Omnitram, tramadol, and paroxetine.
      After the 9th study drug dose, six blood samples will be collected (1.0, 1.5, 2.0, 2.5, 4.0,
      and 8.0 hours after the 9th dose is administered) to quantify the Omnitram and tramadol.
      After the 9th dose, pain tolerance will be assessed with a cold pressor test (immersion of
      hand in ice cold water). Participants will washout for 11-15 days after treatment 1 and
      treatment 2. The study will analyze treatment side effects, the pharmacokinetics, and pain
      tolerance.
    

Intervention name(s): Omnitram; Tramadol; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Omnitram tablets overencapsulated; Tramadol tablet overencapsulated; Microcrystalline powder overencapsulated
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: analgesia, Cytochrome P450 2D6
Cerebellar Neuromodulation to Enhance Fear Extinction and Predict Response to Exposure Therapy
Condition: Anxiety Disorders; Social Phobia
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      Emerging neuroimaging studies have shown that the cerebellum contributes to different aspects
      of timing, prediction, learning, and extinction of conditioned responses to aversive stimuli,
      factors that may be relevant to the success of exposure based behavioral therapy. Our goals
      are to determine the cerebellar contributions to fear extinction by attempting to modulate
      key pathways in this process by theta burst stimulation. The long term goal is to lay the
      foundation for future studies in which neuromodulation is used to augment exposure therapy.
    

Detailed description: 
      Participants in this study will undergo an assessment for past history and present symptoms
      of mood, anxiety, trauma, substance abuse, and eating disorders. Safety screening for
      functional MRI (fMRI) and repetitive transcranial magnetic stimulation (rTMS) will be
      performed prior to enrollment.

      Phase 1 of the study involves two visits. The first visit involves undergoing an fMRI scan
      and a motor thresholding procedure for rTMS. A clinical assessment will be performed for the
      above symptoms, or a recap of symptoms if the participant had been previously assessed at our
      institute.

      The second visit involves a fear conditioning session performed in the fMRI scanner followed
      by one session of rTMS over either a cerebellar or occipital lobe (control) target. This will
      be immediately followed by a fear extinction phase, also in the fMRI scanner. The participant
      will return in 24hours to determine consolidation of the fear extinction process.

      Phase 2 is similar to Phase 1, except that each participant will undergo two sessions of the
      fear conditioning and fear extinction phases while undergoing an fMRI scan. In one session,
      they will receive rTMS over a cerebellar target. In the other session, they will receive rTMS
      over a control site. These sessions will be separated by at least 1 week.

      The participants will then undergo 10 weeks of exposure therapy for social phobia. The goal
      is to determine whether neuroplasticity related to cerebellar stimulation can predict the
      response to exposure therapy.
    

Intervention name(s): Transcranial Direct Current Stimulation
Intervention type(s): Device
Intervention description(s): tDCS is a non-invasive form of neuromodulation in which direct current is administered placed over a brain region of interest to induce physiological changes such as inhibition or excitation over that region.
Other intervention name(s): tDCS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Social Phobia; Anxiety; Cerebellum; tDCS; Neuromodulation; Fear Extinction
Enhancement of Postocclusive Reactive Hyperaemia by Dipyridamole
Condition: Hyperemia; Hypoxia
MeSH terms: Hyperemia; Hypoxia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether dipyridamole enhances postocclusive
      reactive hyperaemia by increasing extracellular adenosine concentrations during ischemia and
      reperfusion. Furthermore we hypothesize that dipyridamole augments postocclusive reactive
      hyperaemia by increasing adenosine receptor stimulation.
    


Intervention name(s): dipyridamole; caffeine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Dipyridamole; Caffeine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: adenosine; caffeine; dipyridamole
Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and
      thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical
      cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents
      platform. Therefore, this Phase IIIb study is designed to evaluate the safety and
      immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals'
      (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either
      vaccine alone.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): Boostrix ® Polio; GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM)
Intervention type(s): Biological; Biological
Intervention description(s): One dose of vaccine administered intramuscularly; Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively
Other intervention name(s): dTPa-IPV vaccine; GlaxoSmithKline (GSK) Biologicals' HPV vaccine (580299); HPV-16/18 L1 AS04 vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human Papillomavirus
Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention
Condition: Sleep Disordered Breathing; Upper Airway Collapsibility; Upper Airway Obstruction
MeSH terms: Respiratory Aspiration; Sleep Apnea Syndromes; Airway Obstruction
Study type: Interventional

Summary: 
      The investigators hypothesized that sleeping in a 45 degrees elevated body position decreases
      the likelihood of upper airway vulnerability to collapse early after delivery. Furthermore,
      the investigators want to elucidate the anatomical and physiological risk factors that
      contribute in the upper airway obstruction in post-partum patients.
    

Detailed description: 
      After obtaining study consent, each patient underwent measurements of upper airway
      cross-sectional area (CSA) during daytime within 48 h after delivery. The minimum upper
      airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry;
      Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position.
      This method has been previously used and validated in pregnant women.

      In the patients who further gave consent for the sleep study, polysomnography (PSG) was
      performed throughout the entire study night. Within a crossover design, patients were
      randomly assigned to receive first either nonelevated or 45° elevated upper body position.
      Position was changed after 3.5 h by a member of the team.
    

Intervention name(s): elevated body position; supine body position
Intervention type(s): Procedure; Procedure
Intervention description(s): 45 degrees elevated upper body position; non-elevated upper body position
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers
Condition: Healthy
Study type: Interventional

Summary: 
      Oral anticoagulants that are widely used for the treatment of thrombo-embolic disease exert
      their effect by blocking the recycling of vitamin K. Vitamin K acts as a co-factor in the
      posttranslational carboxylation of vitamin K-dependent proteins such as osteocalcin and
      matrix-gla protein. It is important to quantify the dose-response relationship of the
      interaction between vitamin K and oral anticoagulants and to investigate at what dosage
      vitamin K will interfere with oral anticoagulants in a clinically relevant way.
    

Detailed description: 
      From all K-vitamins, menaquinone-7 has been identified as the most effective cofactor for the
      carboxylation reaction of Gla-proteins. In this respect it is important to quantify the
      dose-response relationship of the interaction between oral anticoagulants and menaquinone-7.
      The primary objective of the study is to demonstrate at what menaquinone-7 intake the vitamin
      will interfere with oral anticoagulants in a clinically relevant way. Clinically relevant is
      defined as a decrease in level of anticoagulation that would require a change in oral
      anticoagulant treatment in order to stay within target levels. Secondary objective of the
      study is to investigate changes in carboxylation level of osteocalcin and matrix-gla protein
      after menaquinone-7 supplementation during the oral anticoagulation treatment period. This
      will demonstrate whether during oral anticoagulation menaquinone-7 will be transported
      preferentially to the liver or to other target tissues.
    

Intervention name(s): acenocoumarol; menaquinone-7
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): max 5 mg per day during 10 weeks; In successive weeks (6 weeks) the dosage is increased over the range 10 µg to 20 µg increasing to 45 µg MK-7 for the final week.
Other intervention name(s): sintrom mitis; MenaQ7
Intervention MeSH terms: Vitamin K 2; Vitamin K; Acenocoumarol; Menaquinone 7
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitamin K2; oral anticoagulation; interference; level of anticoagulation; carboxylation level of osteocalcin and matrix-gla protein
A Study in Healthy Men to Test How Well Different Doses of BI 1839100 Are Tolerated (1490-0001)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial starts the clinical development of BI 1839100. Effects of single rising doses of
      BI 1389100 on safety, tolerability and pharmacokinetics will be assessed as basis for further
      development in patients with pulmonary fibrosis.
    


Intervention name(s): BI 1839100; Placebo; allyl isothiocyanate (AITC)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 1839100; Placebo; allyl isothiocyanate (AITC)
Intervention MeSH terms: Phenethyl isothiocyanate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment