bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Rigid Tapping on Chronic Functional Ankle Instability in Basketball Players
Condition: Ankle Inversion Sprain
Study type: Interventional

Summary: 
      This study aims rigid tapping on chronic functional ankle instability in professional
      basketball players.
    

Detailed description: 
      Lateral ankle sprains (LASs) are common injuries in sports and physical activities, with up
      to 40% of individuals experiencing a first-time LAS developing chronic ankle instability
      (CAI). LASs predominantly affect the anterior talofibular ligament, and residual symptoms can
      persist in a significant percentage of patients. However, many individuals with ankle sprains
      do not seek professional treatment, leading to potential underestimation of the injury
      severity. CAI is characterized by recurrent episodes of ankle giving way, ongoing symptoms,
      reduced ankle range of motion, diminished self-reported function, and persistent ankle
      sprains beyond one year. It is attributed to both mechanical and functional instability, with
      factors such as proprioceptive deficits and mechanical insufficiencies contributing to the
      condition. Taping, particularly rigid taping, is commonly used by athletes to enhance joint
      stability and improve dynamic balance and functional performance. Rigid taping limits joint
      movement, improves joint position, and provides external support without compromising
      functional performance. Taping is especially prevalent in multidirectional sports like
      basketball, where ankle sprains are frequent. The use of tapes aims to restrict ankle
      movement, increase joint stability, and enhance proprioception without hindering athletic
      performance.
    

Intervention name(s): Rigid Tape
Intervention type(s): Other
Intervention description(s): The patient was rested in supine or long sitting position on a table Pre-wrap was applied to cover all the area before tapping Two strips used separately as anchors at the two ends of the pre-wrap. Two Longitudinal stirrup of tape were used from medial side of the superior anchor to lateral side of the same anchor.
Two horizontal stirrup of tape were used from medial side of the distal anchor to lateral side of the same anchor to support the medial side of the foot.
Figure-of-eight straps were utilized for the taping. Lateral heel lock was applied.The tape then proceeded from the lateral side of the foot, looping around the heel, and returning to the same starting point by crossing over the Achilles tendon from behind.
Medial heel lock was applied, the tape application was similar to the lateral heel lock but was at the opposite direction.
Superior and inferior anchors were applied to support all the previous strips
Intervention model: Single Group Assignment
Intervention model description: pre post study design
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device
Condition: Healthy
Study type: Interventional

Summary: 
      This study is a randomized, double-blind, and sham-controlled trial to examine the effects of
      transcranial magnetic stimulation on the brain of health individuals.
    

Detailed description: 
      The efficacy of repetitive transcranial magnetic stimulation on the brain will be assessed by
      multimodal neuroimaging in healthy individuals.
    

Intervention name(s): Neurostar TMS Therapy System, NeuroStar XPLOR System
Intervention type(s): Device
Intervention description(s): Repetitive transcranial magnetic stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Transcranial magnetic stimulation; Magnetic resonance imaging; Magnetic resonance spectroscopy
Safety Study of Olanzapine and a Comparator in Patients With Schizophrenia and Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess whether olanzapine and/or risperidone affect the way the human body
      uses sugar in the blood.
    


Intervention name(s): olanzapine; risperidone
Intervention type(s): Drug; Drug
Intervention description(s): 5-20 mg, oral, capsules, daily, 12 weeks.; 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
Other intervention name(s): LY170053; Zyprexa
Intervention MeSH terms: Olanzapine; Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
PROtocol for Coxsackievirus VaccinE in Healthy VoluNTteers
Condition: Viral; Infection, Coxsackie(Virus)
MeSH terms: Virus Diseases; Coxsackievirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1, first-in-human, randomized, double-blind, placebo-controlled,
      multiple-dose-escalation study to evaluate the safety, tolerability and immunogenicity of
      PRV-101, a coxsackie virus B vaccine, in healthy volunteers.
    

Detailed description: 
      Thirty two healthy adult subjects will be enrolled into 2 dose cohorts (low-dose and
      high-dose cohorts, 16 subjects per cohort) and will be randomized in a double-blind manner to
      PRV-101 or placebo in a 3:1 ratio. Each subject will receive up to 3 administrations of the
      study drug (PRV-101 or placebo) at 4-week intervals and will be followed for 24 weeks after
      the final dose. Each cohort will start with a sentinel dosing group (2 subjects). Cohort 2
      will commence after safety data from the first 2 doses from all Cohort 1 participants are
      reviewed.
    

Intervention name(s): PRV-101; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Coxsackie Virus B vaccine; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coxsackie Virus B, vaccine
Benefit and Tolerability of IQP-LU-104 in Weight Loss
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This study is to evaluate the benefit and tolerability of two dosages of IQP-LU-104 (5120mg
      and 2560mg daily) in reducing body weight in overweight and moderately obese subjects
    


Intervention name(s): High dose IQP-LU-104 (5120mg); Low dose IQP-LU-104 (2560mg); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1 sachet to be taken 2 times daily orally, together with 2 main meals; 1 sachet to be taken 2 times daily orally, together with 2 main meals; 1 sachet to be taken 2 times daily orally, together with 2 main meals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Flaxseed mucilage; Weight loss; Satiety
Effects Of Consumption Of A Highly Mineralized Sodium Bicarbonated Water On Blood Lipid Profile
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      The aim of the study is to assess the beneficial effect of the short term consumption of the
      highly mineralized bicarbonated sodium water on blood lipid parameters compared to a low
      mineralized water.
    


Intervention name(s): sparkling highly mineral bicarbonated sodium water
Intervention type(s): Other
Intervention description(s): 1,25 liter a day at the mealtimes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Blood triglyceride; Bicarbonated mineral wate; Post-prandial triglyceridemia; lipid metabolism; Cardiovascular risk
Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to assess the safety of a gene and cell therapy for autologous donor
      lymphocyte infusion in HIV+ participants with well-controlled viremia on antiretroviral
      therapy.
    


Intervention name(s): AGT103-T
Intervention type(s): Biological
Intervention description(s): An autologous, genetically modified PBMC product enriched with HIV-specific and resistant CD4 T cells
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combined rTMS and Relaxation in Chronic Tinnitus
Condition: Chronic Tinnitus
MeSH terms: Tinnitus
Study type: Interventional

Summary: 
      Repetitive Transcranial Magnetic Stimulation in combination with relaxation therapy is used
      to modulate the neural pathways contributing to the perception and distress of phantom
      sounds.
    

Detailed description: 
      Tinnitus is the phantom auditory perception of sound in the absence of an external or
      internal acoustic stimulus. It is a frequent problem which can interfere significantly with
      the ability to lead a normal life. One significant modulator of tinnitus is stress. Tinnitus
      has been shown to be generated in the brain, as a result of functional reorganization of
      auditory neural pathways and the central auditory system. Also non-auditory cortical areas of
      attention allocation and emotional processing was shown to be involved. Treatment remains
      difficult. The most effective treatment in chronic tinnitus is cognitive behavioral therapy
      including elements of relaxation therapy. Repetitive transcranial magnetic stimulation (rTMS)
      is also effective in treatment of tinnitus with moderate effect size. Pilot data were
      positive for low-frequency rTMS applied to the temporoparietal areas and high-frequency rTMS
      applied to the left frontal cortex. Newer findings indicate that exercise-combined
      non-invasive brain stimulation might show superior effects in contrast to rTMS or exercise
      alone. Combination of relaxation and two-sided (frontal and temporo-parietal) rTMS will be
      examined with regard to feasibility, safety and clinical efficacy in patients suffering from
      chronic tinnitus in a pilot trial.
    

Intervention name(s): Left DLPFC Butterfly Coil
Intervention type(s): Device
Intervention description(s): High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions.
Arms: Left DLPFC Butterfly Coil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: repetitive transcranial magnetic stimulation; chronic tinnitus; relaxation
Fiber Regimens for Constipation Symptoms
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The objective of the current study is to compare the effects of bowel recipe with psyllium on
      symptoms associated with constipation.
    

Detailed description: 
      Patients presenting to the urogynecology clinics at Parkland Health and Hospital System and
      UT Southwestern Medical Center at Dallas from July 2003 to July 2005 were screened for
      symptoms of constipation. Subjects were randomized to a 6-week course of either psyllium
      (Konsyl, Konsyl Pharmaceuticals, Easton, MD) or a special bowel recipe. The bowel recipe was
      a modification of that used by Behm and consisted of 1 cup of unprocessed wheat bran, 1 cup
      of applesauce, and 1/4 cup of prune juice. A validated constipation scoring questionnaire12
      was administered to participants at the beginning and at the end of the six-week study
      period. During the six-week trial patients also kept a bowel diary recording characteristics
      of each bowel movement.
    

Intervention name(s): Psyllium; Bowel recipe
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md); consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.
Intervention MeSH terms: Psyllium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bowel recipe; Bristol stool form scale; Konsyl; psyllium; wheat bran
Open-label, Crossover, Food Effect Study to Evaluate CT-044 in Healthy Human Volunteers
Condition: Pain, Acute; Acute Pain; Surgery; Neuropathy
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label study will be conducted to assess the bioavailability and PK of oral single
      doses of CT-044 following administration with and without food and to evaluate the safety and
      tolerability of CT-044 when given with and without food.
    

Detailed description: 
      The food effect study will be an open-label, 2-sequence, balanced crossover design in 12
      subjects previously untreated with CT-044.

      Eligible subjects will be admitted to the Clinical Trial Unit on the day prior to dosing and
      remain in house until Day 3. Each subject will receive CT-044 single oral dose once under fed
      conditions (i.e., a high fat meal per FDA recommendations) and once in the fasted state.

      9 Subjects will return to the Clinical Trial Unit on an outpatient basis for follow-up.
      Subjects will return to the Clinical Trial Unit to be treated by the second sequence after a
      washout period of at least 7 days, but no more than 14 days. All procedures will be repeated
      for the second treatment sequence. When possible, the procedures conducted at the 144-hour
      follow-up visit for the first sequence may serve as baseline for the second sequence of the
      crossover.
    

Intervention name(s): CT-044
Intervention type(s): Drug
Intervention description(s): CT-044 HCl is a reactive species decomposition accelerant
Intervention model: Single Group Assignment
Intervention model description: The dose to be utilized for the evaluation of food effect will be CT-044 600 mg single dose.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Single Dose; Pharmacokinetics; PK; CT-044 HCl; Food Effect
Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis.
Condition: Cutaneous Leishmaniasis, American
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This project is composed of a phase I study with the purpose of evaluating adverse reactions
      and the best dose to be used of Sm29 and a phase II randomized controlled study with 3 arms
      with the purpose of comparing the efficacy of meglumine antimoniate associated with Sm29,
      with meglumine antimoniate plus placebo and meglumine antimoniate alone in the treatment of
      cutaneous leishmaniasis.
    

Detailed description: 
      The phase I study was performed in 10 healthy subjects and 10 patients with CL. In healthy
      individuals (N=5) Sm29 was applied to healthy skin at a concentration of 5ug and in another 5
      Sm29 was used at a dose of 10ug applied twice a day for 20 days. A phase I study was also
      carried out in 10 patients with CL to assess the occurrence of adverse reactions to Sm29
      applied to the ulcerated lesion and to compare the use of two doses of Sm29. In 5 patients,
      Sm29 was used at a dose of 5ug and applied twice a day, and in 10 patients, a dose of 10ug of
      Sm29 was used, also applied twice a day. The 10 patients were also treated with glucantime at
      a dose of 20mg/kg/weight with a maximum dose of 1200mg/day intravenously for 20 days.
      Patients were evaluated on days 10, 20 and 30 for adverse reactions.
    

Intervention name(s): Sm29 Protein, Schistosoma Mansoni; Pentavalent antimony (Sbv)
Intervention type(s): Drug; Drug
Intervention description(s): Sm29 cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.; Placebo cream twice a day in the ulcer(s), during 20 days; and Systemic IV Pentavalent antimony (Sbv) at 20mg/kg/day during 20 days.
Other intervention name(s): Pentavalent antimony (Sbv); Placebo cream
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized and controlled
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cutaneous Leishmaniasis; Sm29; L. braziliensis
Effect of Antioxidants on Ocular Blood Flow, Endothelial Function, and Cytokine Levels in LPS Induced Inflammatory Model in Humans.
Condition: Retina; Regional Blood Flow; Endotoxin, Escherichia Coli
MeSH terms: Escherichia coli Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      Oxidative stress, which refers to cellular damage caused by reactive oxygen intermediates,
      has been implicated in many disease processes, especially age-related disorders. Many trials
      investigating use of antioxidants in protecting different tissues against oxidative stress
      have been conducted, but the results are ambiguous.

      Inflammation is generally associated with enhanced oxidative stress and widespread
      endothelial dysfunction. In the present study, the infusion of LPS, which is a cell wall
      component of Gram-negative bacteria and a major mediator in the pathogenesis of septic shock,
      will be used as a standardized experimental model of systemic inflammatory response in
      humans. The assessment of outcome parameters will include measurements of ocular blood flow,
      forearm blood flow and plasma concentration of cytokines. Measurements of ocular hemodynamics
      provide an unique chance to investigate local blood flow in humans non-invasively. Moreover,
      the retina is especially susceptible to oxidative stress because of its high consumption of
      oxygen, its high polyunsaturated fatty acid content, and its exposure to visible light.
      Evidence from literature clearly supports a role for oxidative stress in pathophysiology of
      several ocular diseases including diabetic retinopathy and age-related macular degeneration.
      To investigate the retinal vascular reactivity we will use systemic hyperoxia as a stimulus.
      The measurement of forearm blood flow will be use to assess endothelial function. The main
      study objective is to investigate the effect of oral vitamins and minerals supplementation on
      impaired retinal vascular reactivity after LPS administration.
    


Intervention name(s): vitamin and mineral supplement; Escherichia coli Endotoxin (LPS); 100% O2; nitroglycerin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): dose: 4 tablets daily for two weeks
vitamin A 7160 IU, vitamin C 113mg, vitamin E 100IU, zinc 17.4mg, copper 0.4mg; dose: 2 ng/kg (corresponding to 20 IU/kg), intravenous bolus over 5 minutes on both study days; breathing for 30 minutes, 2 breathing periods on both study days; dose: 0,8 mg sublingual, applied during FMD measurements on both study days
Other intervention name(s): Ocuvite preservision; US Standard Endotoxin; Nitrolingual Pump Spray
Intervention MeSH terms: Nitroglycerin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of the Snackability Smartphone Application to Improve Quality of the Snack Intake, General Diet Quality, and Weight Among College Students
Condition: Obesity; Diet, Healthy
Study type: Interventional

Summary: 
      The Snackability was a two-arm, 12-week randomized control trial among 272 overweight college
      students. Participants were equally randomized to the intervention group (access to the app)
      or control group (no access to the app). Diet and weight were assessed at baseline, at 4
      weeks, at 8 weeks, and at 12 weeks.
    


Intervention name(s): Snackability app; Control group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This app allows user to search for a snack (scan barcode or type snack name), add a portion size consumed based on a portion size guide, and then provide a snack score and breakdown scores with a specific feedback message about the score.25 A score ranging from 0-10 points was designed taking into account the first ingredient, the nutrient standard by portion size, and the processing of foods (score ranging from -1 to 1 was subtracted or added depend on processed food classification). The final score ranged from -1 to 11 points. The higher the score, the more compliant it is to the guideline; therefore, the healthier the snack is. The app also provides gamification features as self-motivation (level up and achievement gained) and reporting features as goal-setting and self-monitoring (average daily score and consumed snack history).; The control group received a 1-page with information on what is a healthy snack from the USDA: https://www.fns.usda.gov/cn/tools-schools-focusing-smart-snacks. They were given access to the app after the 12-week study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
The Effect of Anesthesia Type on Pulmonary Function
Condition: Anesthesia; Geriatric Patients
Study type: Interventional

Summary: 
      The role of neuraxial anesthesia in preventing respiratory complications is a controversial
      in elderly patients. The aim of the study was to evaluate the benefits of neuraxial
      anesthesia on pulmonary function during post-operative term in geriatric patients undergoing
      to elective non-abdominal surgery.
    

Detailed description: 
      Sixty elder patients will be randomly assigned to General anesthesia or Neuraxial anesthesia
      groups. Spirometry, will be performed at pre-operative and post-operative terms. Pulmonary
      function tests will be evaluated.
    

Intervention name(s): General anesthesia; Neuraxial anesthesia; Spirometer
Intervention type(s): Procedure; Procedure; Diagnostic Test
Intervention description(s): induction with the intravenous anesthetic (Propofol) and maintenance with the inhalational anesthetic (Sevoflurane); Spinal anesthesia will be applied via the local anesthetic ( Bupivacaine).; Pulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy)
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening