bioihbjkbjnl/mcl2 huggingface dataset:
Axumin PETMRI Imaging Following Focal Cryo-ablation (FCA)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This is a prospective outcomes study assessing quality of life and oncological control at
      pre-defined time points following FOCAL CRYO-ABLATION (FCA). The investigator's standard of
      care is to perform an Magentic Resonance Imaging (MRI) and prostate biopsy two years
      following FCA. The prostate biopsy assesses both the presence of in field and out of field
      disease. The role of Axumin PET/MRI for detecting disease following FCA has not been
      previously examined.
    

Detailed description: 
      The primary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years
      following FCA will improve sensitivity for detection of in field recurrence of significant
      prostate cancer defined as any Gleason pattern 4 disease.

      The secondary hypothesis of this study is that 18F-Fluciclovine PET/MRI imaging at two years
      following FCA will improve sensitivity for detection of out of field recurrence of
      significant prostate cancer .
    

Intervention name(s): Standard of Care MRI; Fluciclovine PET scan added to MRI
Intervention type(s): Device; Other
Intervention description(s): Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies; 18F-Fluciclovine (Axumin) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 18F-Fluciclovine PET imaging; Focal Cryo Ablation
Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)
Condition: Ankylosing Spondylitis; Spinal Fractures
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Fractures, Bone; Spinal Fractures
Study type: Observational [Patient Registry]

Summary: 
      Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial
      skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During
      the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been
      successfully introduced to reduce the disease activity. It is unclear whether bDMARD
      treatment had an effect on spinal fracture risk related to AS. This national registry study
      will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort
      of patients with AS.
    


Intervention name(s): bDMARD treatment
Intervention type(s): Drug
Intervention description(s): Treatment with bDMARD includes registered ATC-codes: L04AA and L04AB.
Other intervention name(s): Biological Disease Modifying Drug treatment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with AS as registered in the Swedish Patient Registry with ICD-9-code 720 or
        ICD-10 code M45.9.
Management of Mandibular ORN: PENTO as Medical Treatment
Condition: Osteoradionecrosis
MeSH terms: Osteoradionecrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic
      and irreversible complication after head and neck radiotherapy with no medical treatment to
      limit or reduce symptoms.

      Different clinical trials have shown a significant scientific evidence that the treatment
      with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the
      tissue fibrosis. This study proposes to use this drugs to determine if there is healing of
      mandibular osteoradionecrosis and/or a symptomatic improvement as well.
    

Detailed description: 
      Mandibular osteoradionecrosis which occurs after the use of radiation therapy for the
      treatment of head and neck cancer remains being the most problematic and irreversible
      complication despite its low incidence with no medical treatment to limit or reduce symptoms.

      Clinical trials conducted to date have shown a significant scientific evidence that the
      treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment
      of the tissue fibrosis that have been irradiated based on the properties of this drugs in
      increased tissue oxygenation and their antioxidant effect.

      The aim of this study is to determine if there is a clinical improvement of mandibular
      osteoradionecrosis using Pentoxifylline in combination with Tocopherol as treatment because,
      currently, there is no effective treatment to achieve bone healing and/or a symptomatic
      improvement.
    

Intervention name(s): Pentoxifylline and Tocopherol
Intervention type(s): Drug
Intervention description(s): pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).
Other intervention name(s): PENTO
Intervention MeSH terms: Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol; Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mandibular osteoradionecrosis; Tocopherol; pentoxifylline; vitamine E; wounds and injuries; antioxidants; free radical scavengers; radiation-protective agents; vasodilatadors agents; osteonecrosis; mandible; extraoral fistula; exposed bone; necrotic bone; head and neck radiotherapy
Effect of Palivizumab on Later Recurrent Wheezing in Preterm Infants
Condition: Recurrent Wheezing; Wheezing; Asthma
MeSH terms: Recurrence; Respiratory Sounds
Study type: Observational

Summary: 
      The hypothesis of the present study is that the prophylaxis with palivizumab to prevent the
      severe RS virus infection during the infancy among preterm infants may reduce the risk of
      subsequent recurrent wheezing in childhood.

      The infants born between July 1st and December 31st in 2007 with the gestational age between
      33 and 35 weeks were enrolled into the study at the end of RS virus infection season, April
      2008. The infants were unintentionally divided into two groups, either palivizumab treated or
      untreated group at the enrollment, because the timing for palivizumab prophylaxis were
      already ended.

      The study infants will be followed up until the age of 3 with recording the incidence of
      either parent reported or physician diagnosed recurrent wheezing.

      The difference of the incidence of the recurrent wheezing between the groups will be analyzed
      with Kaplan-Meier method.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants with the gestational age between 33 and 35 weeks
      
Biospecimen description: 
      serum
    
Keywords: recurrent wheezing; asthma; preterm infants; palivizumab; atopic diseases
Risedronate for the Prevention of Osteoporosis in People With Spinal Cord Injury.
Condition: Acute Spinal Cord Injury.
MeSH terms: Osteoporosis; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out if Risedronate works to prevent osteoporosis after
      spinal cord injury.
    


Intervention name(s): Risedronate
Intervention type(s): Drug
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Osteoporosis; Spinal Cord Injury
Trial of FK614 in Type 2 Diabetics Inadequately Controlled on a Sulfonylurea
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to assess the safety and efficacy of FK614 in type 2 diabetic
      subjects receiving sulfonylurea (SU) monotherapy.
    

Detailed description: 
      This is a prospective randomized, double-blind, placebo controlled, parallel group, Phase 2
      study. Subjects meeting selection criteria will be randomly assigned to receive 12 weeks
      twice daily (BID) dosing with FK614 or placebo. Enrollment for this study will be
      approximately 200 patients.
    

Intervention name(s): FK614
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Pilot Study to Evaluate the Effect of Pomegranate Juice on Semen Parameters in Healthy Male Volunteers
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 1

Summary: 
      How daily consumption of pomegranate juice affects the concentration, morphology or motility
      of sperm in healthy men.
    

Detailed description: 
      To determine, in this pilot study, whether daily consumption of pomegranate juice (POM)
      affects the concentration, morphology or motility of sperm in healthy men. The purpose of the
      present pilot study is to examine the hypothesis that POM may improve semen parameters in
      men.
    

Intervention name(s): Pomegranate juice
Intervention type(s): Dietary Supplement
Intervention description(s): Pomegranate juice
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Male infertility
Impact of Restriction of the Non Paretic Upper Limb Rehabilitation of Patients a With Stroke:Randomized Clinical Trial
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      To evaluate whether the restriction of the non paretic upper limb (UL) is a factor that could
      interfere at the sensorimotor UL recovery for chronic stroke subjects and to verify the
      impact on daily function, quality of life. In this pilot, randomized, blind and allocation
      concealment clinical trial, nineteen individuals with chronic stroke was randomly assigned,
      after the first evaluation, into two groups: group without restriction (G1), subject only to
      the specific training of paretic UL, and restricted group (G2), which underwent specific
      training of paretic UL and use of the restriction of non paretic UL
    


Intervention name(s): specific training of paretic upper limb
Intervention type(s): Other
Intervention description(s): nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL. The volunteers were evaluated before the beginning of the interventions, and the next day after completion of the 12 therapy sessions through the Fugl-Meyer Assessment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hemiparetic; cognitive; balance
Confocal Laser Microscopy in Non Erosive Reflux Disease
Condition: Acid Reflux Disease; Heartburn
MeSH terms: Gastroesophageal Reflux; Heartburn
Study type: Observational

Summary: 
      Heartburn or reflux disease affects about 20% of Americans. 50 - 70% of people who have
      endoscopy for reflux disease have a normal appearing esophagus. Confocal Laser Microscopy
      allows us to see changes in the cells not visable during routine endoscopy. Whe goal of this
      study is to identify the use of this new technique in diagnosing reflux in patients who have
      normal appearing esophagus.
    

Detailed description: 
      Gastroesophageal reflux disease (GERD) remains a major problem in the United States affecting
      about 20% of Americans. Upper endoscopy (EGD) is commonly used to diagnose and grade GERD
      based on mucosal breaks and erosions. It is now evident from multiple studies however that
      the majority of GERD patients (50-70%) have negative EGDs.These patients are refered to as
      "Non Erosive Reflux Disease" (NERD) patients.Confocal Laser Microscopy (CLM) is a new
      endoscopic technique that offers the advantage of detecting histologic changes during real
      time endoscopy and thus can diagnose NERD. We thus propose to study the sensitivity and
      specificity of CLM in predicting NERD. We hypothesize that CLM can reliably diagnose NERD in
      the appropriate clinical setting based on intrapapillary capillary loop patterns. This will
      be a pilot study after which a randomized trial will evaluate the reversibility of these
      changes after PPI therapy as seen by CLM
    

Intervention name(s): Cell~vizio (Laser connfocal microscopy)
Intervention type(s): Device
Intervention description(s): completed during endoscopy
Other intervention name(s): Mauna Kea Cellvizeo
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        age 18 - 65 years symptoms of acid reflux disease
      
Biospecimen description: 
      esophageal biopsy
    
Keywords: reflux; heartburn
Pharmacokinetics of a Single Oral Dose of 1,800 mg Red Vine Leaf Extract (Antistax®)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To describe the plasma and urinary pharmacokinetics of quercetin glucuronide and kaempferol
      glucuronide after the administration of a single peroral dose of 1,800mg Red Vine Leaf
      Extract (Antistax®). Additionally, the trial evaluated the safety and tolerability of this
      dose in healthy subjects.
    


Intervention name(s): Red Vine Leaf Extract
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Combining more than one drug may kill more cancer cells.

      PURPOSE: Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating
      patients who have advanced cancer of the esophagus.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the objective response rate in patients with advanced squamous cell
      carcinoma of the esophagus treated with carboplatin and docetaxel. II. Assess the toxicity of
      this regimen in these patients. III. Assess the time to progression and overall survival of
      this patient population.

      OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, followed by carboplatin IV over
      15-30 minutes on day 1. Treatment is repeated every 3 weeks for 6 courses in the absence of
      disease progression or unacceptable toxicity. Patients are followed every 3 months until year
      2, every 6 months during years 2-5, and then annually thereafter until death.

      PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study at a rate of 30
      patients per year.
    

Intervention name(s): carboplatin; docetaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carboplatin; Docetaxel
Primary purpose: Treatment
Keywords: stage III esophageal cancer; stage IV esophageal cancer; squamous cell carcinoma of the esophagus
The Effects of Rifaximin Therapy in Irritable Bowel Syndrome
Condition: IBS
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      To evaluate the efficacy of Rifaximin therapy started prior to completion of advanced
      examination procedure (before colonoscopy) of patients pre-diagnosed with irritable bowel
      syndrome, and implement it into clinical practice.
    

Detailed description: 
      Irritable Bowel Syndrome(IBS) is a chronic relapsing disorder with unknown etiology
      characterized by abdominal pain and bowel habit changes without an organic pathology.
      Pathophysiology is not fully understood, bacterial overgrowth is one of the reasons. Because
      of that, use of drugs effective on the gut flora has been raised; Rifaximin is one of them.
      This study investigated the effectiveness of Rifaximin on IBS.

      This randomized, double-blinded, controlled study began with 500 patients(144 of them removed
      because of incompliance). Patients those without organic bowel pathology and whom meet the
      Rome-III criteria, aged between 19-50 yo were enrolled in the study. Patients with known
      Rifaximin allergy, lactose intolerance, and those having treated for IBS whit in last 1 month
      as well as those with alarm symptoms (melena, fever, weight loss, anemia, rectal bleeding)
      were excluded. After routine biochemistry, blood count, and stool tests, Rifaximin tablet was
      given to a group as 1200 mg. daily in 3 divided doses, placebo tablet was given to another
      group in same doses for 10 days. Improvement in symptoms were scored and recorded on 10.day,
      3. and 6.week. In addition to descriptive statistical methods(mean±SD), Student's-T and
      Mann-Whitney U-tests were used for comparison of quantitative data, chi-square and McNemar
      tests were used for comparison of qualitative data. Significance was accepted if p <0.05.
    

Intervention name(s): Rifaximin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rifaximin tablet is given as 200 mg 3x2/daily, for 10 days.
Other intervention name(s): Colidur 200 mg tablets
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: IBS; Rifaximin
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital
Condition: Premature Infants
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant
      formulas supplemented with different levels of LCPUFA, for premature infants following
      discharge from Hospital.
    


Intervention name(s): LCPUFA
Intervention type(s): Dietary Supplement
Intervention description(s): premature infant formula supplemented with LCPUFA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: fat formulation
The Effect of Drain Use on Patient Comfort in Laparoscopic Sleeve Gastrectomy
Condition: Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Introduction Laparoscopic sleeve gastrectomy surgeon; Have become increasingly morbid obesity
      treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort
      and early return to life are the criteria that should be given priority in this treatment
      method. The purpose of this study is to determine the use of drain, which closely affects
      these criteria; And the effect on patient comfort.
    

Detailed description: 
      Question the necessity of routine use of drain in Laparoscopic sleeve gastrectomy surgeon
    

Intervention name(s): Drainage
Intervention type(s): Other
Intervention description(s): Using drain after operation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; VAS; Pain; Laparoscopy; Sleeve
Pulse Oximetry in Healthy SubjEcts ImmergeD in OceaN.
Condition: Drowning
MeSH terms: Drowning
Study type: Observational

Summary: 
      Drowning is the 3rd leading cause of accidental death in the world. One of the tools used by
      lifeguards to help ER assess gravity, is pulse oximetry. Its measure is variable even in
      optimal condition and its accuracy can be altered by factors specific to the patient and by
      environmental factors. The conditions gathered during a drowning rescue are thus propitious
      to a misleading evaluation. Assessing its reliability and looking for influencing factors of
      the measure of pulse oximetry could help for pre-hospital care management.
    

Detailed description: 
      The research focuses on the measurement of pulse oximetry among lifeguard on the Atlantic
      coast of Gironde, France, before and after their daily training, using a standardized
      measurement protocol.

      The follow-up will be done during the beach monitoring period during the summer of 2020. A
      total of 3 months of measurement collection is expected.
    

Intervention name(s): Drowning
Intervention type(s): Other
Intervention description(s): Measurement of pulse oximetry, after lifeguard immersion during their morning training
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Lifeguards working on the Girondine Atlantic coast