bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Long Distance Mountain Race on Knee Cartilage.
Condition: Sports Medicine
Study type: Observational

Summary: 
      Long-distance mountain running is increasingly popular among European and North America
      countries. Long-distance races are organized in various mountains and can reach up to 160 km
      (100 miles) with several thousands meters of climbing. The pathophysiological consequences of
      such extreme effort is still a matter a debate. From a muskelo-skeletal perspectives, the
      potential lower-limb join damage is a major health issue. The present study aims to use
      objective magnetic resonance imaging (MRI) techniques to describe the consequences of
      performing long-distance mountain running races on the knee cartilage.
    

Detailed description: 
      Healthy male runners will perform T2 MRI knee cartilage examination before, immediatly after
      and 1 month after 3 distinct long-distance mountain races of 40, 55 and 160 km. The
      physiological responses during the races (speed, heart rate, glycemia) will also be
      recordered.
    

Intervention name(s): Long-distance mountain running
Intervention type(s): Other
Intervention description(s): Impact of a mountain race on the knee cartilage
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy male runners
      
Keywords: long-distance running; knee cartilage; magnetic resonance imaging
Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme
Condition: Glioblastoma Multiforme of the Brain
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for Glioblastoma Multiforme provide very limited benefit to the
      patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
      beneficial in the treatment of brain tumors.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive
      Glioblastoma Multiforme.
    

Detailed description: 
      OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with
      residual/recurrent/progressed Glioblastoma Multiforme receive gradually escalating doses of
      intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose
      is reached. Treatment continues for at least 12 months in the absence of disease progression
      or unacceptable toxicity.

      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in adults (≥ 18 years of age) with
           residual/recurrent/progressive Glioblastoma Multiforme following initial therapy,
           including radiotherapy, as measured by an objective response to therapy (complete
           response, partial response or stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in adults (≥ 18 years of
           age) with residual/recurrent/progressive Glioblastoma Multiforme.

        -  To determine objective response, tumor size is measured utilizing MRI scans, which are
           performed every 8 weeks for the first two years, every 3 months for the third and fourth
           years, every 6 months for the 5th and sixth years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Adults with a residual/recurrent/progressive Glioblastoma Multiforme will receive Antineoplaston therapy (Atengenal + Astugenal).
The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult glioblastoma; recurrent glioblastoma
Piracetam for Treatment of Cocaine Addiction - 3
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of IV cocaine administration in cocaine
      dependent subjects maintained on piracetam while they are residing in an inpatient addictions
      treatment research unit and to subsequently follow these patients in an eight week open label
      assessment of piracetam in an outpatient treatment program.
    


Intervention name(s): Piracetam
Intervention type(s): Drug
Intervention MeSH terms: Piracetam
Primary purpose: Treatment
Keywords: cocaine
Autonomic Innervation and MIBG Imaging
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with symptomatic atrial fibrillation (AF), a rapid beating of the upper heart
      chambers, can undergo catheter ablation to control or eliminate their rhythm disorder. The
      radiopharmceutical 123I-mIBG (Adreview™ GE Healthcare) has been introduced to visually
      identify cardiac innervation. This study will use non-invasive evaluation using MIBG imaging
      to study if we can predict baseline autonomic characteristics in patients with AF, as well as
      clinical outcome based on post ablation imaging
    

Detailed description: 
      This is a single centre, interventional, Phase III trial using the radiopharmaceutical
      123I-mIBG for imaging. In this pilot study, up to 7 eligible participants will undergo
      pre-ablation and post ablation nuclear imaging.

      The major objective of our study is to evaluate the relationship between non-invasive imaging
      of cardiac innervation with invasive mapping of atrial innervation as determined by High
      Frequency Stimulation (standard of care to physiologically document autonomic function). This
      will be followed by the clinical ablation procedure, as discussed by the cardiac
      electrophysiologist, consisting of pulmonary vein (PV) antral isolation, inclusive of regions
      of autonomic innervation, and sites showing complex fractionated atrial electrograms (CFAE)
      when clinically indicated.

      The secondary objective is to determine the relationship between catheter ablation of AF and
      non-invasive nuclear imaging of cardiac innervation.
    

Intervention name(s): Iodine-123 Meta-iodobenzylguanidine
Intervention type(s): Other
Intervention description(s): A single injection of the 123I-mIBG will be given. Imaging will be done twice following injection: at 0120 minutes and 3-5 hours. The timing is dependent on the specific participant and imaging characteristics.
The imaging is done for approximately 24 minutes at each time point.
Other intervention name(s): 123I-mIBG
Intervention MeSH terms: 3-Iodobenzylguanidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: atrial fibrillation; atrial cardiac innervation; catheter ablation of atrial fibrillation; High Frequency Stimulation; ganglionated plexuses; 123I-mIBG; nuclear imaging
Safety of Hib Vaccine (Bio Farma)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to know the safety of Hib/PRP-T vaccine and immediate
      reactions within the first 30 minutes after injection.
    

Detailed description: 
      This trial was an open-label study, no randomization, and no placebo or control group. Total
      25 young healthy adult (volunteers) followed this trial. The safety was assessed within 24
      hours, 48 hours, 72 hours, and 28 days after injection.
    

Intervention name(s): Hib/PRP-T vaccine
Intervention type(s): Biological
Intervention description(s): Hib liquid vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adults; Hib vaccines; Immunogenicity; Safety
An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants to Study Electrocardiogram Effects
Condition: Systemic Lupus Erythematosus; Healthy Participants
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to investigate the experimental medication BMS-986165 in healthy participants
      in order to study the effects it has on electrocardiogram results.
    


Intervention name(s): BMS-986165; Moxifloxacin; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Moxifloxacin; Deucravacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (301)
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed
      to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123
      Vehicle Lotion.
    

Detailed description: 
      This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed
      to assess the safety, efficacy, and tolerability of IDP-123 Lotion and IDP-123 Vehicle
      Lotion. To be eligible for the study subjects must be at least 9 years of age and have a
      clinical diagnosis of moderate to severe acne.
    

Intervention name(s): IDP-123 Lotion; IDP-123 Vehicle Lotion
Intervention type(s): Drug; Drug
Intervention description(s): Tazarotene 0.045% Lotion; Vehicle Lotion
Other intervention name(s): IDP-123; Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Dexmedetpmidine Versus Ketamine for Postoperative Sore Throat in Sinus Surgery
Condition: Sore Throat
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this randomized clinical trial is to evaluate the impact of dexmedetomidine versus
      ketamine soaked pharyngeal packing on postoperative sore throat in functional endoscopic
      sinus surgery (FESS).
    

Detailed description: 
      A written informed consent was taken from the patients.patients will be randomly assigned to
      three groups of 40 subjects each; dexmedetomidine or ketamine or saline soaked pharyngeal
      packs were situated under direct vision. Throat packs made of gauze with a length of 20 cm
      and a width of 10 cm (folded transverse four times) and medications were diluted with 20 ml
      normal saline. The packings were placed by the surgeon blinded to the study groups.

      1-Dexmedetomidine group: 75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the
      posterior pharyngeal wall after induction of anesthesia and & endotracheal tube (ETT).

      2-Ketamine group: 50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior
      pharyngeal wall after induction of anesthesia and ETT.

      3-Control group: 20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior
      pharyngeal wall after induction of anesthesia and ETT.
    

Intervention name(s): Dexmedetomidine; Ketamine; saline 0.9%
Intervention type(s): Drug; Drug; Other
Intervention description(s): 75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.; 50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.; 20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
Other intervention name(s): Precedex; ketalar; Normal saline
Intervention MeSH terms: Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Robotic Versus Abdominal Surgery for Endometrial Cancer
Condition: Endometrial Neoplasms
MeSH terms: Endometrial Neoplasms
Study type: Interventional

Summary: 
      This study is intended to explore differences in oncologic and surgical safety between
      robotic assisted laparoscopy and conventional abdominal surgery for high risk endometrial
      cancer.
    

Detailed description: 
      Hypothesis: Robotic assisted laparoscopy (RAL)is equal in terms of oncologic and surgical
      safety as conventional abdominal surgery (AS) for high risk endometrial cancer (EC).

      Methods: Women with high risk EC (defined as high grade endometrial, clear cell or serous)
      are randomized to either RAL or AS. Both groups will undergo complete surgical staging
      (hysterectomy, bilateral salpingoophorectomy, pelvic and paraaortal lymphadenectomy)

      Primary endpoint: Number of harvested lymph nodes per station Secondary endpoints:
      Recurrences up to 3 year after surgery. Lymphatic side-effects, quality of life, cost,
      surgical morbidity.
    

Intervention name(s): Robotic surgery; Abdominal surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Minimal invasive surgery performed with daVinci robotic system; Current gold standard
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
SpyGlass Direct Visualization System Clinical Registry in China
Condition: Biliary Tract Diseases
MeSH terms: Biliary Tract Diseases
Study type: Observational [Patient Registry]

Summary: 
      To document indications for cholangioscopy and clinical utility of the SpyGlass Direct
      Visualization System in China when used per standard of practice.

      Prospective, Post market, Multi-center, Non-randomized Study
    

Detailed description: 
      Patients who presenting with an indication for cholangioscopy or presenting with a possible
      indication for cholangioscopy to be determined during the ERCP procedure immediately
      preceding the SpyGlass procedure will join this study, totally 500 patients across 16 sites
      throughout China will participate in study. After SpyGlass operation, all patients will be
      followed for 72 hours to observe adverse events, and patients with indeterminate stricture or
      undefined filling defect indication with tissue sampling not yielding histopathology positive
      for malignancy and unresolved device and/or procedure related SAE at 72 Hours will continue
      to be followed up until 6 months. Finally, procedure success rate will be analyzed as primary
      endpoint, and SAEs and impact of patients management will be analyzed as secondary endpoint.
    

Intervention name(s): SpyGlass
Intervention type(s): Device
Intervention description(s): The SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All consecutive patients seen at an investigational site during the enrollment period

          -  Presenting with an indication for cholangioscopy, or

          -  Presenting with a possible indication for cholangioscopy to be determined during the
             ERCP procedure immediately preceding the SpyGlass procedure.
Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's Disease
Condition: Healthy; Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety of a single dose of Lu AF82422, how
      well it is tolerated, how the drug effects the body and what the body does to the drug in
      healthy non-Japanese and Japanese subjects and in patients with Parkinson's disease
    


Intervention name(s): Lu AF82422; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose; placebo - concentrate for solution for infusion, single dose
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Cohort
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Performance of Curing Times and Intensitis
Condition: Clinical Performance
Study type: Interventional

Summary: 
      The aim of the study is to compare the effect of high intensity light cure (2200 mw/cm2) for
      1 second with low intensity light cure (1200 mw/cm2) for 20 seconds on the clinical
      performance of bulk fill resin composite restorations in compound Class II cavities of
      posterior teeth
    

Detailed description: 
      The prepared cavities will be conditioned with 35% phosphoric acid gel for15 seconds, then
      will be rinsed and dried with compressed air. Then application of universal adhesive system
      to all cavity with bond brush then light cured for 10 seconds using LED light curing unit
      (1200 mw/cm2). Extra-Fill bulk fill resin composite will be applied in onebulk increment and
      will be light polymerized for 1 second using (LED) light curing unit (2200 mw/cm2).for
      intervention group Extra-Fill bulk fill resin composite will be applied in one bulk increment
      and will be light polymerized for 20 seconds using (LED) light curing unit (1200 mw/cm2) fot
      control group
    

Intervention name(s): High intensity light cure
Intervention type(s): Device
Intervention description(s): Bulk fill resin composite restoration cured with high intensity light curing (2200 mw/cm2)To achieve increased power and a wider spectrum for short exposure time (1 second) to overcome resin composite restoration techniques sensitivity and shorten the clinical procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Dermacyd Breeze (Lactic Acid) Pocket BR - Photo Evaluation
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the absence of photoirritation and photosensitization potential of the product
      Dermacyd Breeze (Lactic Acid) Pocket BR.
    


Intervention name(s): Lactic Acid
Intervention type(s): Drug
Intervention description(s): Lactic Acid (Dermacyd Breeze)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      This is a prospective, non-randomized, open-label study to look at the uptake, adherence to,
      and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing,
      and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in
      Zimbabwe.
    

Detailed description: 
      The reproductive needs of HIV-discordant couples who desire pregnancy represent an urgent
      public health problem that has been neglected in HIV prevention research. In Zimbabwe , and
      across sub-Saharan Africa, the vast majority of HIV-infected individuals are adults of
      reproductive age. Pregnancy and the desire for children are common among HIV-infected
      individuals, and HIV-discordant couples face a difficult choice between attempting pregnancy
      and risking HIV transmission to their partners. Recent surveys have found that 30-50% of
      HIV-infected individuals in sub-Saharan Africa are involved in stable, HIV-discordant
      relationships, and HIV transmission within married, cohabitating HIV-discordant couples
      accounts for 44-60% of new HIV infections in some regions of sub-Saharan Africa. While
      knowledge of HIV discordance can lead to increased condom use, many discordant couples have
      unprotected intercourse often motivated by the desire to conceive. Currently, HIV discordant
      couples who attempt to conceive place themselves at considerable risk of transmission. This
      research study aims to help promote couples' rights to conceive while at the same time
      decreasing the risk of HIV transmission.
    

Intervention name(s): PrEP (Truvada); Antiretrovirals; Semen washing; Artificial vaginal insemination
Intervention type(s): Drug; Drug; Procedure; Procedure
Intervention description(s): oral, daily Truvada for HIV-negative participants; oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant; collection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination; collection of semen from an HIV-negative man, followed by intravaginal insemination
Other intervention name(s): emtricitabine/tenofovir disoproxil fumarate; ART
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Anti-Retroviral Agents
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        HIV-discordant couples in Harare, Zimbabwe who are trying to get pregnant
      
Keywords: HIV-discordant couple; ART; PrEP; semen washing; artificial vaginal insemination; safer conception; pregnancy