bioihbjkbjnl/mcl2 huggingface dataset:
Vitamin D and Cardiovascular Events in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Cardiovascular Disease
MeSH terms: Arthritis; Arthritis, Rheumatoid; Cardiovascular Diseases
Study type: Observational

Summary: 
      The aim of the study is to evaluate cardiovascular events during long-term follow-up in
      Rheumatoid Arthritis. The primary outcome "any cardiovascular event" will be evaluated using
      systematic audits of patient records, and will be associated to low levels of vitamin D at
      baseline, to investigate the hypothesis that low levels of vitamin D can be part of a
      prediction model for cardiovascular disease in Rheumatoid Arthritis.
    

Detailed description: 
      Cardiovascular morbidity and mortality is increased in patients with rheumatoid arthritis
      (RA), and among these patients, the prevalence of hypo-vitaminosis D is high. Low levels of
      vitamin D have been associated with elevated cardiovascular risk in healthy subjects. The
      objective of this study is to evaluate the risk of cardiovascular events in patients having
      low 25OHD-total levels at baseline compared to patients with sufficient levels, in an
      aggressively treated closed cohort of early-diagnosed RA patients.

      The primary outcome will be the proportion of patients with any cardiovascular event,
      evaluated using systematic journal audits. Logistic regression models will be applied to test
      the hypothesis that there are more cardiovascular events in patients enrolled with a low
      level of vitamin D (< 50 nmol/l). Secondarily, Cox regression models, based on survival
      analysis, will be applied, to determine the extent to which independent variables (including
      different levels of vitamin D at baseline) predict not only whether a cardiovascular event
      occur, but also when it will occur.
    

Intervention name(s): Baseline serum vitamin D level below 50 nmol/l; Baseline serum vitamin D level at or above 50 nmol/l
Intervention type(s): Other; Other
Intervention description(s): There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis; There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Hundred-and-sixty early diagnosed and treatment-naive RA patients, recruited from five
        Danish University Clinics (Trial Centres) from October 1999 to October 2002
      
Keywords: Rheumatoid Arthritis; Cardiovascular event; Cardiovascular mortality; Vitamin D
Web-based Intervention to Improve Executive Functioning in Teens With Epilepsy (Epilepsy Journey)
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish the feasibility, accessibility, acceptability, and
      preliminary efficacy of an individually-tailored intervention to improve EF in adolescents
      with epilepsy (EFI-E).
    

Detailed description: 
      Epilepsy is a common childhood condition affecting approximately 326,000 youth in the United
      States. Adolescents with epilepsy are at significant risk for poor social and academic
      outcomes, neurobehavioral comorbidities (i.e., internalizing and externalizing symptoms), and
      poor treatment adherence. Studies have shown that one potential reason for these poor
      outcomes are deficits in executive functioning (EF), defined as the skills necessary for
      goal-directed and complex activities, including problem-solving, initiation, monitoring,
      organization, planning, self-regulation and working memory. EF deficits have been documented
      in 1/3 of youth with epilepsy, which is 3 times the prevalence in healthy youth.
      Evidence-based interventions to improve EF could play a critical role in preventing adverse
      outcomes (e.g., psychological comorbidities, non-adherence to the treatment regimen) and
      promoting optimal functioning in adolescents with epilepsy; however none exists for this
      vulnerable population. The aim of the current study is to establish the feasibility,
      accessibility, acceptability, and preliminary effects of an individually-tailored
      intervention to improve EF in adolescents with epilepsy (Executive Functioning
      Intervention-Epilepsy; EFI-E). Thirty participants will be recruited who have at least one
      clinically-elevated EF subscale or at least two at-risk subscale scores (> 1 standard
      deviation above the mean) on the parent Behavior Rating Inventory of Executive Function
      (BRIEF®)) to qualify for the EFI-E. EFI-E will consist of 10 web-based modules addressing
      foundational EF skills. Each online module will be accompanied by a videoconference with a
      therapist to review the skills and problem solve around adolescent-identified goals. Baseline
      and post-treatment questionnaires will be completed by adolescents and primary caregivers and
      electronically-monitored adherence will be obtained throughout the open trial. Participants
      will be in the trial for 9 months.
    

Intervention name(s): EFI-E
Intervention type(s): Behavioral
Intervention description(s): This is 10 web-based modules addressing foundational EF skills. Each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around adolescent-identified goals.
Intervention model: Single Group Assignment
Intervention model description: Patients are receiving an executive functioning intervention in an open trial design-pre-post
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: executive functioning
MagnezixKids Study
Condition: Magnesium-based; Bioresrobable Implants; Pediatric Elbow Fractures; Osteosynthesis; Childhood; Magnezix; Elbow Fracture
MeSH terms: Fractures, Bone; Elbow Fractures
Study type: Interventional

Summary: 
      The overall objective of the study is to describe the outcomes of osteosyn-thesis with
      magnesium based screws in children with a primary or second-ary (within 7 days from trauma)
      dislocated fracture of the Epicondyles ul-naris or Condylus radialis, and to compare them
      with outcomes of conven-tional osteosynthesis using steel screws.

      If our results suggest non-inferiority of osteosynthesis with magnesium-based screws, the
      procedure could be tested formally in a subsequent full-size study.
    


Intervention name(s): Osteosynthesis with resorbable Material
Intervention type(s): Device
Intervention description(s): Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia
Other intervention name(s): Magnezix (Syntellix) screws
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of The Efficacy and Safety of Tixel Treatment for the Treatment of Facial and/or Scalp Actinic Keratoses
Condition: Actinic Keratoses
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional

Summary: 
      Evaluation of the Efficacy and Safety of a thermal fractional skin treatment system (Tixel)
      for the treatment of facial and/or scalp actinic keratoses
    

Detailed description: 
      Single-center, Prospective, Open Label, with Before-After Study Design. Up to 25 subjects
      will be enrolled to the study to provide at least 20 evaluable subjects. Subjects will be
      examined to determine the severity and extent of actinic keratoses.

      All subjects will undergo 1-3 treatments (determined by their clinical improvement), 3-4
      weeks apart.

      Follow-up visits after the last treatment visit: 4 weeks (±7 days), 12 weeks (±7 days), 52
      weeks (±14 days) - the last follow up visit is a voluntary one.

      The inclusion criteria would be mild to moderate thickness confluent actinic keratoses
      located to scalp and/or face.
    

Intervention name(s): Tixel
Intervention type(s): Device
Intervention description(s): Non-invasive thermo-mechanical treatment
Intervention model: Single Group Assignment
Intervention model description: Single-center, Prospective, Open Label, with Before-After Study Design
Masking: None (Open Label)
Primary purpose: Treatment
Extended Versus Limited Thoracoscopic Sympathectomy: Its Impact on Palmar and Plantar Hyperhidrosis
Condition: Hyperhidrosis Due to Autonomic Dysregulation (Disorder)
MeSH terms: Autonomic Nervous System Diseases; Primary Dysautonomias; Hyperhidrosis
Study type: Interventional

Summary: 
      Conclusions: In the context of palmar and plantar hyperhidrosis, extended thoracoscopic
      sympathectomy seemed to be preferred over limited thoracoscopic sympathectomy due to better
      overall outcomes and minimal time for hospital stays and Compensatory hyperhidrosis.
    

Detailed description: 
      ABSTRACT Objective: The aim was to carefully evaluate and compare the results of extended
      sympathectomy versus T3, T4, and T5 resection in cases of palmer, axillary, and planter
      hyperhidrosis as regards decreased sweating and recurrence rates.

      Methods: This was a randomized controlled prospective trial conducted at the Department of
      Vascular Surgery Mansoura University Hospitals on a total of 120 patients with hyperhidrosis
      who were divided into two groups; group 1 who had undergone limited sympathectomy and group 2
      who had undergone extended sympathectomy.
    

Intervention name(s): thoracoscopic sympathectomy
Intervention type(s): Procedure
Intervention description(s): sympathectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Plant-based Dietary Protein and Resistance-training Adaptations
Condition: Healthy
Study type: Interventional

Summary: 
      Dietary protein consumption maximizes the anabolic response during resistance training (RT)
      by triggering muscle protein synthesis and providing the indispensable amino acids for a net
      positive protein balance. Leucine is considered the key amino acid in this process,
      suggesting that differences in protein quality may influence RT-induced gains in muscle mass
      and strength. In general, plant-based protein sources have lower leucine concentrations than
      animal-based protein sources and human skeletal muscle. In this respect, despite acute
      evidence on lower anabolic properties of plant- vs. animal-based protein, the effects of an
      exclusive plant-based dietary protein diet on RT-induced adaptations are currently unknown.
    


Intervention name(s): whey protein; soy protein
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): supplementation individually adjusted to 1.6g/kg/day; supplementation individually adjusted to 1.6g/kg/day
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: protein source; hypertrophy; resistance training; plant-based protein; omnivorous
Implant Site Preparation With Piezosurgery vs Conventional Drills in Terms of Operation Time, Implant Stability and Bone Density
Condition: Implant Osteotomy
Study type: Interventional

Summary: 
      The preparation of the implant site has a major influence on the success rate and long-term
      survival of dental implants. Piezoelectric devices and special implant drilling inserts are
      now emerging to replace conventional drills.
    


Intervention name(s): Piezosurgery assisted osteotomy; Conventional drilling osteotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Sequential osteotomy drilling was done using mectron piezosurgery implant drilling protocol; bone osteotomy for implant placement was done following the BEGO Semados RS/RSX TrayPlus conventional drilling
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth
Masking: None (Open Label)
Primary purpose: Treatment
An Assessment of the In Vivo Biological Effects of Diethyldithiocarbamate (DTC) in HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To determine, in HIV-infected patients, the magnitude and duration of the biological effects
      of ditiocarb sodium (sodium diethyldithiocarbamate; DTC) that may be relevant to treatment of
      HIV infection.

      DTC has been studied in previous clinical trials in HIV-infected patients with the suggestion
      of delay in disease progression to AIDS and improvement in CD4 counts while on the drug.
    

Detailed description: 
      DTC has been studied in previous clinical trials in HIV-infected patients with the suggestion
      of delay in disease progression to AIDS and improvement in CD4 counts while on the drug.

      Two groups of patients, one group asymptomatic and the other with AIDS diagnosis, are
      enrolled in the study. All patients receive DTC intravenously once a week for two weeks.
      Drugs are given on days 1 and 8. Blood samples are drawn on days 1, 3, 5, 8, 10, and 12.
    

Intervention name(s): Ditiocarb sodium
Intervention type(s): Drug
Intervention MeSH terms: Ditiocarb
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Evaluation; Ditiocarb; Acquired Immunodeficiency Syndrome
Local Haemodynamic Effects of Apelin Agonists and Antagonists in Man in Vivo
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Apelins are substances which occur naturally in the body, and have an important role in heart
      disease. They have been shown to make blood vessels dilate, and improve the way the heart
      works.

      The investigators have devised 2 sets of experiments to investigate how the apelins affect
      blood vessels.

      In the first group of experiments,the investigators will give healthy volunteers up to 3
      different apelin substances, and use special research techniques to see how they affect the
      way that blood vessels work in the forearm.

      In the second group of experiments, the apelins will be given along with another form of
      apelin which blocks the effects of apelin in laboratory experiments. The investigators want
      to see if it blocks the effects of apelin in healthy humans.

      The investigators intend to test the hypothesis that:

      Apelin agonists are vasodilators in human resistance vessels, this effect will be blocked by
      an apelin receptor antagonist.

      This study will help us to understand more about how apelins work, and to suggest how they
      might be used to treat heart disease.
    


Intervention name(s): Forearm venous occlusion plethysmography; Aellig hand vein technique; Apelin agonist infusion; Apelin receptor antagonist infusion
Intervention type(s): Procedure; Procedure; Other; Other
Intervention description(s): Forearm venous occlusion plethysmography to study to measure forearm blood flow during intra-arterial infusion of the apelin peptides.; Hand vein measurements will be used to assess the response to apelin peptides and apelin receptor blocker in the human hand vein vascular bed.; Escalating doses of apelin (1/10/100nmol/min) will be administered.; Dose finding study (range 1-300nmol/min) and co-infusion study with apelin peptides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Trial of RSL Versus WL for Malignant Breast Disease
Condition: Breast- Female
MeSH terms: Breast Diseases
Study type: Interventional

Summary: 
      The purpose of this randomized trial is to determine the superiority of utilizing radioactive
      seed localization (RSL) over wire-guided localization (WL) for palpable or non-palpable
      malignant lesions in patients undergoing breast conservation surgery (BCS).
    

Detailed description: 
      Consented and eligible subjects will be randomized to either radioactive seed localization or
      wire localization and stratified by surgeon and invasive versus DCIS prior to localization.
      Subjects on both arms will undergo breast conservation surgery including surgical specimen
      removal. Specimens will be grossed according to standard of care procedures. Localization,
      breast conservation surgery, and post-operative appointments will follow standard of care
      guidelines. Surveys will be administered according to the study calendar to the radiologist,
      surgeon, pathologist, and subject for data collection.
    

Intervention name(s): Radioactive Seed Localization; Wire Localization
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study will evaluate an oral fixed-dose, once daily product that combines pramipexole and
      rasagiline for the treatment of early Parkinson's disease.

      Animal studies support the therapeutic advantage of combining low doses of rasagiline and
      pramipexole and suggest further improvement when both are administered in a sustained
      fashion. Both rasagiline and pramipexole are well known marketed drugs for Parkinson's
      disease with a good safety profile. combining the drugs in low doses and controlled release
      may provide better symptom management than the existing drugs alone or together.
    


Intervention name(s): P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),; Placebo; P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily; placebo; Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
Intervention MeSH terms: Pramipexole; Rasagiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's Disease, Rasagiline, Pramipexole
Effects of Lagenbone on Bone Mineral Density
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional

Summary: 
      To study the effects of the herbal supplement Lagenbone on Bone Mineral Density
    

Detailed description: 
      To study the effects of the herbal supplement Lagenbone on Bone Mineral Density. Lagenbone is
      a supplement based on the Chinese Herbal formula Gui Lu Er Xian Jiao.
    

Intervention name(s): Lagenbone
Intervention type(s): Dietary Supplement
Intervention description(s): Traditional Chinese medicine herbal formula
Other intervention name(s): Gui Lu Er Xian Jiao
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chinese medicine; herbal medicine; osteoporosis; bone mineral density
Therapeutic Education in Parkinson's Disease: What Impact on Drug Representations of Patients? (ETPARK-REMED)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Dopaminergic drug can have adverse effects leading to potential serious consequences.
      Therapeutic patient education must promote the understanding of drugs to improve its
      management. This study tries to evaluate the effect of therapeutic education workshop on
      Parkinson disease's drug (drug workshop) on the evolution of drug's representations in
      patients with Parkinson's disease compared to a control group.
    

Detailed description: 
      Dopaminergic drug can have adverse effects leading to potential serious consequences.
      Therapeutic patient education must promote the understanding of drugs to improve its
      management.

      The therapeutic educational program ETPARK includes individual's consults or workshop. The
      team frequently offer to patients to participate in workshop on Parkinson disease's drug.

      This study tries to evaluate the effect of therapeutic education workshop on Parkinson
      disease's drug (drug workshop) on the evolution of drug's representations in patients with
      Parkinson's disease compared to a control group (speaking group) at 1 and 3 months.
    

Intervention name(s): Therapeutic education workshop; Speaking Therapy
Intervention type(s): Other; Other
Intervention description(s): Workshop on Parkinson disease drug has several educative sequences (lasting 4hours).
A first round table is organized to know the needs and issues related to drug management of patients.
The 1st educative sequence consists in knowing the different class of dopaminergic drugs and their action.
The 2nd educative sequence leads patients to understand their prescription and be aware of the needs to take pills regularly.
The 3rd educative sequence consists in learning and identifying potentials adverse effects and finds effective strategies to prevent them.
At the end, one patient explains its tips and tricks about its drug management; Speaking group is leaded by a psychologist from Centre Expert Parkinson (lasting 2 hours). This specific time is an exchange between patients with Parkinson disease who feel free to come. It is about sharing its own experience. It is a very special moment, confidential and kindly where patients don't judge themselves and speak only if they want to.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: therapeutic education or speaking group
Masking: None (Open Label)
Primary purpose: Other
Keywords: Therapeutic education; Parkinson Disease; Socials representations
Bioequivalence Study of Montelukast Sodium Tablets 10mg Under Fed Condition
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, balanced, two-treatment, two-period, two-sequence, single
      dose, crossover, oral bioequivalence study.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose,
      crossover, oral bioequivalence study of Montelukast sodium tablets 10mg of Dr. Reddy's
      Laboratories Limited, India comparing with that of SINGULAIR® (containing Montelukast sodium)
      tablets 10mg of Merck Sharp & Dohme Ltd., USA in healthy, adult, human subjects under fed
      conditions.
    

Intervention name(s): Montelukast sodium
Intervention type(s): Drug
Intervention description(s): Montelukast sodium tablets 10mg
Other intervention name(s): SINGULAIR
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Montelukast Sodium; crossover