bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the safety and efficacy of treatment with adalimumab in adults with
      moderate to severe hidradenitis suppurativa (HS).
    

Detailed description: 
      The clinical trial identifier is PIONEER I. The purpose of this study is to evaluate the
      safety of adalimumab and to determine how well it works in the treatment of adults with
      moderate to severe HS. HS is a chronic skin disease that creates red, swollen, painful bumps
      which can break open to combine and form tunnels in the skin and scars. Sometimes these bumps
      can heal themselves quickly and sometimes they will become much worse and create sores that
      heal with multiple combined scars, or areas that do not heal. In this study, approximately
      300 adults will be enrolled at treatment centers worldwide. Subject participation in this
      study will be up to 50 weeks. There will be a screening period, which will last from 7 to 30
      days, and a study treatment period of up to 36 weeks. Study visits occur at Screening,
      Baseline, and Weeks 2, 4, 8, 12, 14, 16, 20, 24, 28, 32 and 36 (or sooner if subject leaves
      the study before Week 36). The study is divided into two treatment periods. The first period
      (Period A) will last 12 weeks and the second period (Period B) will last up to 24 weeks.
    

Intervention name(s): adalimumab; placebo
Intervention type(s): Biological; Biological
Intervention description(s): Adalimumab pre-filled syringe, administered by subcutaneous injection; Placebo pre-filled syringe, administered by subcutaneous injection
Other intervention name(s): Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: acne; psoriasis; hidradenitis suppurativa; TNF; HS; PIONEER I; acne inversa; boil; placebo controlled; Double blind; adalimumab
PK PD of the Enantiomers of Tramadol and O-desmethyltramadol in Elderly and Young Subjects
Condition: Aging; Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates the pharmacokinetics and pharmacodynamics of the enantiomers of tramadol
      and O-desmethyltramadol (ODM) in generally healthy young and elderly adults. Using a
      randomised, double-blind, crossover design, participants were administered a single 200mg
      tramadol extended-release tablet and placebo.
    

Detailed description: 
      The pharmacokinetics of the enantiomers of tramadol and O-desmethyltramadol (ODM) have not
      been extensively studied in elderly patients. Given the importance of hepatic function in the
      metabolism of tramadol into the more potent ODM metabolite and the fact that tramadol is
      primarily renally excreted, age-related changes in hepatic and renal function may affect the
      pharmacokinetics and pharmacodynamics of tramadol. Data on the pharmacokinetics of tramadol,
      the ODM metabolite and their enantiomers will provide important information as to the source
      of any differences in the metabolism or elimination of Tramadol Contramid® OAD in the elderly
      as compared to younger subjects. Differences in the PK of tramadol and O-desmethyltramadol
      could result in differences in Pharmacodynamics of tramadol, specifically in analgesic
      effect. An Electrically Stimulated Pain Model was used to evaluate any differences in current
      perception and pain tolerance between the age groups.
    

Intervention name(s): Tramadol extended release 200 mg; CP/T; Placebo
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Tramadol extended release 200 mg: Administration of a single 200mg tramadol extended-release tablet; Subjects were evaluated for perception and tolerance of electrical current. An experimentally induced pain model utilizing electrical stimulation from the FDA approved Neurometer, as the painful stimulus was used to assess Current Perception Threshold and Pain Tolerance Threshold (CP/T) in young and elderly subjects following administration of tramadol and of placebo.; Administration of a single placebo tablet identical in appearance to a 200mg tramadol extended-release tablet
Other intervention name(s): Tramadol Contramid 200 mg extended-release; Electrically stimulated experimental pain model (ESEPM); sugar pill
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Opioid; Geriatric; Pharmacodynamics
A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was a single-center, non-randomized, open-label, one-sequence, two-period,
      within-subject study to investigate the effects of multiple doses of rifampicin on the PK and
      safety of multiple doses of balovaptan in healthy subjects. The study was conducted at 1 site
      in the Netherlands.
    


Intervention name(s): Balovaptan; Rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): In Period 1, balovaptan was administered alone as a once daily (qd) dose on Days 1 to 10.
In Period 2, balovaptan was administered as a qd dose on Days 7 to 16.; In Period 2, 600 mg of rifampicin will be administered alone as a qd dose from Day 1 to Day 6, and as a qd dose on Days 7 to 16.
Intervention MeSH terms: Rifampin; Balovaptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety Evaluation of the Vibrating Capsule
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The study will assess the safety of the vibrating capsule in healthy volunteers first and
      than for constipation relief constipated individuals.
    

Detailed description: 
      Healthy volunteers will be followed for safety for 7 days after taking the capsule.

      Constipated individuals will be first followed for 2 weeks and than they will use the capsule
      for 7.5 weeks period. Safety and efficacy will be evaluated.
    

Intervention name(s): Vibrant capsule
Intervention type(s): Device
Intervention description(s): vibrating capsule
Other intervention name(s): Vibrant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: constipation; gastro; vibrating capsule; safety
Whole-body Vibration on Mucus Clearance, the Quality of Life, and Exercise Capacity for Patients With Chronic Obstructive Pulmonary Disease
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Although whole body vibration (WBV) is mainly designed to promote neuromuscular function,
      however, because of its vibration characteristics, whether it can provide additional effects
      on the sputum clearance for chronic obstructive pulmonary (COPD) disease patients, thereby
      improving the quality of life, and exercise capacity is still unknown.
    


Intervention name(s): A vertical vibration platform PowerVibe Zen Pro 5900; HFCWO
Intervention type(s): Device; Device
Intervention description(s): Subjects received the interventions twice a week for 8 weeks. HFCWO+WBVT group received additional 30 minutes WBVT treatment. In every WBVT session, three rounds of 3 minutes of vibration (amplitude: 2 mm; frequency: 20 Hz) were provided, with a 60-second rest between rounds.; Subjects received the interventions twice a week for 8 weeks. The HFCWO was delivered by a respiratory therapist using a percussive vest at 10-13 Hz oscillating frequency and at a pressure setting of 2 cm H2O. The treatment duration was 25 minutes, and the participants remained in a sitting position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Hydroxychloroquine in Giant Cell Arteritis
Condition: Giant Cell Arteritis
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its
      ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory
      drug that may have a corticosteroid sparing potential according to immuno-pharmacological and
      clinical data. We have designed a multcentric double blind versus placebo randomized
      controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non
      complicated giant cell arteritis.
    


Intervention name(s): hydroxychloroquine/placebo
Intervention type(s): Drug
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: giant cell arteritis,; hydroxychloroquine,; corticosteroid sparing,; corticodependence
Improving Health Literacy in African-American Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Investigators propose an observational interview study to explore how patients understand
      treatment conversations with their physicians within the framework of health literacy. The
      study team will test whether patients' understanding of treatment options and side effects
      can be improved when patients receive a low literacy educational supplement after meeting
      with their urologist. Investigators will interview a group of newly diagnosed, early stage,
      African American prostate cancer patients.
    

Detailed description: 
      Investigators propose an observational interview study to explore how patients understand
      treatment conversations with their physicians within the framework of health literacy. The
      study team will test whether patients' understanding of treatment options and side effects
      can be improved when patients receive a low literacy educational supplement after meeting
      with their urologist. Investigators will interview a group of newly diagnosed, early stage,
      African American prostate cancer patients.

      Investigators hypothesize that the delivery of a scripted, tailored, low literacy educational
      supplement will result in a statistically significant decrease in decisional conflict, and a
      statistically significant improvement in comprehension of cancer treatment and its side
      effects compared to standard practice.

      The study team will measure patients' comprehension of treatment options and side effects, as
      well as decisional conflict; after standard practice, and again after exposure to the
      educational supplement. Investigators will compare the urologists' assessment of patients' 1)
      health literacy 2) preferences for side effects 3) stage of decision making, 4) treatment
      choice or predisposition toward treatment choice. 5) preference for role in decision making
      (active, passive, or shared with physician); to measures obtained from patients. These
      comparisons will allow investigators to quantify the potential benefit to the physician of
      information obtained through the interview and low literacy educational supplement.
    

Intervention name(s): Educational Supplement; Standard Practice Education
Intervention type(s): Other; Other
Intervention description(s): Participants will receive education about prostate cancer and treatments using models and props during a face-to-face interview. During the interview, participants will also be asked about medical terms and treatments regarding prostate cancer. The interview will last 45 to 60 minutes.; Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Urology
A Study to Examine the Effects of Telaprevir on the Pharmacokinetics of Cyclosporine and Tacrolimus in Healthy Adults
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect that telaprevir has on the
      pharmacokinetics of cyclosporine and tacrolimus. Pharmacokinetics means how the drug is
      absorbed into the bloodstream, distributed in the body and eliminated from the body.
    


Intervention name(s): telaprevir; telaprevir; cyclosporine; cyclosporine; tacrolimus; tacrolimus
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet, Oral, 750mg, every 8 hours, Day 1-11 of Period 2; Tablet, Oral, 750mg, every 8 hours, Day 1-13 of Period 2; Solution, Oral, 100mg, Day 1 of Period 1; Solution, Oral, 10mg, Day 1 and Day 8 of Period 2; Capsule, Oral, 2mg, Day 1 of Period 1; Capsule, Oral, 0.5mg, Day 8 of Period 2
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: VX-950
Primary Anterior Cruciate Ligament Repair With and Without Lateral Extraarticular Tenodesis
Condition: Anterior Cruciate Ligament Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The investigators aimed to compare the clinical results of primary repairs and Lateral
      Extraarticular Tenodesis applied with primary repairs in the treatment of proximal ACL tears.
    

Detailed description: 
      The investigators aimed to compare the clinical results of primary repairs and Lateral
      Extraarticular Tenodesis applied with primary repairs in the treatment of proximal ACL
      tears.The aim of this study was to determine the potential for improvement with the primary
      repair of acute ACL tears with the proximal tear, which may be an important advance for
      improvements in proprioception and preservation of natural kinematics.
    

Intervention name(s): Primary anterior cruciate ligament repair; Primary anterior cruciate ligament repair and lateral extraarticular tenodesis (LET) with iliotibial band
Intervention type(s): Procedure; Procedure
Intervention description(s): Only arthroscopic primary anterior cruciate ligament repair was performed in patients with proximal anterior cruciate ligament tear.; In addition to primary anterior cruciate ligament repair, lateral extraarticular tenodesis was performed using the iliotibial band.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: proximal anterior cruciate ligament tear; primary repair; Lateral Extraarticular Tenodesis
Cardiovascular Benefits of Acai Polyphenols in Volunteers at Risk of Metabolic Syndrome
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to carry out a randomized double blind controlled trial in 30
      male subjects to investigate the effect of acai consumption on acute changes in vascular
      function, and to other cardiovascular markers. As a secondary aim the study will allow us to
      characterize the absorption and metabolism of acai polyphenols in humans over a 24 hour
      period.
    


Intervention name(s): Acai puree, frozen blended it with banana; Control Macronutrient matched
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 150g of acai fruit, frozen blended it with banana.; Macronutrient matched control in water and also prepared with banana.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: flow-mediated dilation; Acai polyphenols
Apixaban Versus Warfarin in Patients With Left Ventricular Thrombus
Condition: Left Ventricular Thrombosis
MeSH terms: Thrombosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the novel oral anticoagulant apixaban with the
      standard therapy of warfarin on the size reduction or resolution of left ventricular thrombus
      over 3 months.
    

Detailed description: 
      Current treatment for left ventricular thrombus is anti-coagulant or blood thinning agent
      known as warfarin. Recently at least three novel oral anticoagulant agents were used in the
      treatment of atrial fibrillation, pulmonary embolism and deep vein thrombosis (DVT).

      Novel oral anticoagulant drugs will require no blood taking for INR monitoring, hence less
      visit and more convenience to patients. Latest studies also showed lesser rate of bleeding as
      compared to warfarin and hence relatively safer.
    

Intervention name(s): Apixaban 5 MG Oral Tablet [ELIQUIS]; Warfarin Sodium
Intervention type(s): Drug; Drug
Intervention description(s): Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.; as controlled arm since warfarin is the standard therapy for LV thrombus
Other intervention name(s): ELIQUIS; Coumadin
Intervention MeSH terms: Warfarin; Apixaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Glucagon Resistance in Patients With NAFLD
Condition: Non-Alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; Glucose Metabolism Disorders
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      The investigators propose that the sensitivity to glucagon in hepatic lipid metabolism is
      impaired in subjects with non-alcoholic fatty liver disease (NAFLD) and steatohepatitis
      (NASH). Moreover, they propose a dys-coordinated, reduced glucagon sensitivity in hepatic
      lipid metabolism and endogen glucose production in patients with NAFLD and NASH compared with
      healthy subjects and patients with simple steatosis. This reduced sensitivity may be the
      basis of a more severe dyslipidemia and the production of increased concentrations of toxic
      lipid intermediates in plasma and muscle tissue. The study will include healthy subjects with
      obesity and subjects with simple steatosis and NASH, tested at basal glucagonemia and
      moderate hyperglucagonemia to mimic insulin resistant levels during simultaneous somatostatin
      infusion and replacement doses of insulin and growth hormone. Infusion of palmitate,
      VLDL-triglyceride and glucose tracers in combination with indirect calorimetry as well as
      skeletal and adipose tissue biopsies will be employed to assess free fatty acid and
      VLDL-triglyceride kinetics (turnover, and oxidation) and hepatic fatty acid-esterification.
    


Intervention name(s): glucagon
Intervention type(s): Other
Intervention description(s): Infusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers.
Intervention MeSH terms: Glucagon
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Safety, Tolerability & Efficacy of Certican in de Novo Heart Transplant (Tx) Patients
Condition: Heart Transplantation
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to evaluate whether Neoral dose optimization together with a
      therapeutic drug monitoring of Certican will prevent renal dysfunction as observed in the
      pivotal cardiac trial while maintaining the efficacy.

      This objective will be assessed by comparing renal function post-transplant between 2 groups
      of patients.
    


Intervention name(s): Everolimus (Certican)
Intervention type(s): Drug
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart transplantation; Everolimus; De novo heart transplant patients
Efficacy and Safety of Vaccination Against COVID-19 in Neuromuscular Patients
Condition: Neuromuscular Diseases
MeSH terms: Neuromuscular Diseases
Study type: Observational

Summary: 
      The frequency of severe forms of COVID-19 is higher in people with neuromuscular disease and
      in severe cases and long hospital stays, the disability of some neuromuscular patients may
      worsen due to prolonged bed rest . Finally, the symptoms of certain diseases such as
      myasthenia gravis can worsen after an infection such as COVID-19.

      Thanks to an unprecedented research effort, vaccines are now available and others still in
      development. The first studies published in medical journals are reassuring about the
      efficacy and safety of these vaccines. However, they have been studied in the general
      population and we do not yet have specific information in neuromuscular patients.

      This is the reason why the Va-C-NEMUS observatory was launched.
    

Detailed description: 
      Prevention of COVID-19 in neuromuscular patients is therefore fundamental and vaccination is
      eagerly awaited by patients and their healthcare teams. An unprecedented research effort has
      made it possible to create vaccines in a very short time when no vaccine directed against a
      coronavirus has existed until now. Some of these vaccines are based on proven technologies
      while others such as RNA vaccines are very innovative. The results of the phase III studies
      of 3 of them have just been published (Pfizer/BioNTech, Moderna and Astra-Zeneca). Among
      them, the Pfizer-BioNTech and Moderna vaccines have received authorization for use from the
      European Medicines Agency. The data on the individuals enrolled in these trials are still not
      very detailed. However, we already know that in the Pfizer/BioNTech trial, patients on
      immunosuppressants were excluded. For the Astra-Zeneca vaccine, the publication combines data
      from 4 different trials. In two of them the patients had to be in "good health". In any case,
      we do not know the pathologies presented by patients outside the usual risk factors for the
      severe form of COVID-19 (age, obesity, cardiovascular diseases, respiratory diseases). No
      data on neuromuscular patients are currently known. The vaccination campaign began in France
      in January 2021. The first neuromuscular patients should be vaccinated soon depending on
      their comorbidities, but many questions arise in these patients both in terms of safety and
      efficacy.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): 1 initial questionnaire and 1 monthly follow-up questionnaire for 11 months
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with a neuromuscular disease
      
Keywords: COVID-19; vaccination; safety