bioihbjkbjnl/mcl2 huggingface dataset:
Kineret (Anakinra), in Adult Patients With Colchicine-Resistant Familial Mediterranean Fever
Condition: Familial Mediterranean Fever
MeSH terms: Brucellosis; Familial Mediterranean Fever; Hereditary Autoinflammatory Diseases; Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      FMF is the most common periodic fever with a worldwide patient population estimated as
      150,000, mainly located in the Eastern Mediterranean basin. colchicine is the established
      therapy of choice ,however, around 20.000 patients worldwide fail to respond or cannot
      tolerate therapeutic doses, thereby suffering from recurrent debilitating, severe, painful
      attacks of peritonitis, pleuritis and synovitis and are at risk to die from reactive
      amyloidosis .Mutation-induced reduction in pyrin/ marenostrin activity is thought to underlie
      the disease by leading to NALP3 inflammasome activation ,and thereby to IL-1β related burst
      of inflammation.

      The IL-1 receptor antagonist Kineret (Anakinra), seems to be the most appropriate response to
      the uncontrolled IL-1β elevation. Indeed, an increasing number of reports over the last few
      years indicate a good response to Kineret (Anakinra), in colchicine-resistant FMF ,also in
      children ,however, no controlled study has thoroughly evaluated the efficacy and safety of
      this treatment.

      Study outline:

      The study aims to run at the FMF centre in Sheba Medical Center, covering more than 10,000
      patients. The study will evaluate the effect of recombinant IL-1 receptor antagonist, Kineret
      (Anakinra), on the frequency of FMF attacks in patients that, despite maximum tolerable dose
      of colchicine, present with more than one attack per month.

      The study is designed as a randomised, placebo-controlled, double-blind study. 50 patients
      will be randomised to treatment with either Kineret (Anakinra), or placebo treatment for 4
      months.
    


Intervention name(s): Kineret
Intervention type(s): Drug
Intervention description(s): Patients randomized to active drug will receive Kineret(Anakinra), 100 mg prefilled syringes for subcutaneous injection, once a day for 4 months. The syringes will arrive relabeled from the supplier (SOBI) to Sheba Medical Center. They will be stored at the PI's store room in a temperature controlled refrigerator.
Other intervention name(s): Anakinra
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Colchicine; Anakinra; Colchicine resistance; Familial Mediterranean fever
Protecting Pregnant Women From Infectious Diseases
Condition: Influenza; Pertussis
MeSH terms: Communicable Diseases; Infections; Whooping Cough
Study type: Interventional

Summary: 
      The primary research aim of this project is to test the effectiveness of a comprehensive,
      evidence-based vaccine promotion package implemented in the obstetric setting on increasing
      the likelihood that a pregnant woman in Georgia will receive an influenza and/or pertussis
      vaccine.
    

Detailed description: 
      The primary research aim of this project is to test the effectiveness of a comprehensive,
      evidence-based vaccine promotion package implemented in the obstetric setting on increasing
      the likelihood that a pregnant woman in Georgia will receive an influenza vaccine and/or Tdap
      vaccine before delivery. A secondary research aim assesses whether the comprehensive package
      improves maternal knowledge, attitudes, and beliefs regarding maternal and infant
      vaccination. The intervention package will include evidence-based components aimed at the
      practice-level, provider-level, and patient level and will be tested through a
      cluster-randomized trial design. The primary outcome measure is influenza vaccine receipt
      during pregnancy. The secondary outcomes include 1) receipt of pertussis (Tdap) vaccination
      during pregnancy, and 2) changes in maternal knowledge, attitudes and beliefs regarding
      maternal and infant vaccination. The primary hypothesis is that implementation of a
      comprehensive vaccine promotion package in the obstetric setting will increase the likelihood
      that a pregnant woman receives an influenza and/or pertussis vaccination.
    

Intervention name(s): P3 Vaccine Promotion Package.
Intervention type(s): Behavioral
Intervention description(s): "P3" stands for Practice, Provider, and Patient level vaccine promotion package. The 5 obstetric practices randomized to the intervention arm will receive this comprehensive influenza and Tdap vaccine promotion package at the beginning of the study. Physicians and staff will be familiarized with each component, and practices will be instructed to implement each component to the best of their ability. The components include: posters, educational brochures, lapel buttons, provider-to-patient talking points, lists of nearby locations offering flu and/or Tdap vaccines (if not offered by the practice), identification of a "vaccine champion" within the practice, provider and staff training on vaccination during pregnancy, and use of an interactive, tablet-based educational tutorial for patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Influenza; Pertussis; Vaccination
An Investigation of AGS-009 in Patients With Systemic Lupus Erythematosus (SLE)
Condition: Inflammation; Systemic Lupus Erythematosus (SLE)
MeSH terms: Lupus Erythematosus, Systemic; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in North America. The aim of this clinical trial is to investigate
      the safety, tolerability, pharmacokinetic and signs of bioactivity of increasing single doses
      of AGS-009 in patients with systemic lupus erythematosus (SLE).
    


Intervention name(s): AGS-009; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose in the range of 0.01 to 30 mg/kg administered intravenously (in the vein); Single dose of 0 mg/kg administered intravenously (in the vein) cohort 1-6.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and effectiveness of vildagliptin, an
      unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people
      with type 2 diabetes who have not previously been treated with drug therapy to lower their
      blood sugar.
    


Intervention name(s): vildagliptin
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: type 2 diabetes; vildagliptin
Effect of Dobutamine on Hepatic Blood Flow During Goal-directed Hemodynamic Therapy
Condition: General Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Maintaining adequate perfusion pressure and oxygen supply is essential for organ survival.
      Splanchnic hypoperfusion during the perioperative period in abdominal surgery may result in
      mucosal ischemia with increased permeability of the gut barrier. Additionally, the liver is
      also sensitive for hypoxemia and hypoperfusion, especially during liver surgery.

      Anesthetics (such as propofol or sevoflurane) have a cardiovascular depressant effect,
      resulting in a reduction of cardiac output (CO). Dobutamine is used to counteract myocardial
      depressant effect of anesthetics. Additionally, dobutamine is frequently used during
      abdominal surgery to maintain splanchnic perfusion.

      Dobutamine could increase hepatic blood flow (HBF) indirectly by increasing cardiac output or
      directly by stimulating adrenergic receptors in the splanchnic circulation. The hepatic
      circulation has a large number of alpha and beta adrenergic receptors and could be sensitive
      for adrenergic stimulation such as dobutamine. Hence, dobutamine could have a direct effect
      on the hepatic vasculature.

      The aim of the study is to evaluate the effect of dobutamine on hepatic blood flow during
      goal directed hemodynamic therapy and to distinguish between potential direct and indirect
      effects.
    

Detailed description: 
      All patients receive standardized anesthesia care for pancreaticoduodenectomy according to
      the existing departmental protocol for these interventions.

      All patients receive individualized goal-directed hemodynamic therapy based on the
      transpulmonary thermodilution technique.

      At designated times, hemodynamic variables will be recorded. These include :

        -  Heart rate (bpm)

        -  Central venous pressure (mmHg)

        -  Systolic arterial pressure (mmHg)

        -  Diastolic arterial pressure (mmHg)

        -  Mean arterial pressure (mmHg)

        -  Cardiac index (L/min/m2)

        -  Pulse pressure variation (PPV)

        -  Stroke volume variation (SVV)

      Measurements of hepatic flow and pressure will be performed by the surgeon :

        -  Hepatic flow : in the hepatic artery (arterial HBF) and portal vein (portal HBF).

        -  Pressure measurements : in portal vein (PPorta) and caval vein (PCava)

      Measurements will be done :

        -  without inotropic support

        -  with infusion of dobutamine 2mcg/kg/min

        -  with infusion of dobutamine 5mcg/kg/min
    

Intervention name(s): Dobutamine Hydrochloride
Intervention type(s): Drug
Intervention description(s): dobutamine infusion will be started at 2mcg/kg/min after min 10 minutes dobutamine infusion will be raised to 5mcg/kg/min
Intervention MeSH terms: Dobutamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: hepatic blood flow; dobutamine; hepatic vascular pressure
The Effect of Ischaemic-Reperfusion and Remote Ischaemic Preconditioning in Man - A Bradykinin Dependent Pathway
Condition: Ischaemic Heart Diseases
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional

Summary: 
      Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the
      heart. Current treatments are designed at relieving this blockage as quickly as possible to
      minimize damage to the heart muscle. However in restoring the supply of blood local damage
      known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how
      clot forming and clot dissolving pathways are affected during this process, and examine the
      role of a natural inflammatory hormone, bradykinin. This will help the investigators to
      understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new
      treatments for heart attacks.
    


Intervention name(s): Forearm vascular study; Placebo; bradykinin receptor antagonist (HOE-140)
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Forearm blood flow measured by venous occlusion plethysmography during interarterial infusion of vasodilators (Ach). Venous blood sampling via cannula in antecubital fossa.; Systemic infusion of placebo (saline); Systemic infusion of bradykinin receptor antagonist (HOE-140)
Intervention MeSH terms: Bradykinin; Kininogens; Bradykinin Receptor Antagonists
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Ischaemia reperfusion; Platelet activation; Endothelial function; Remote ischaemic preconditioning; Bradykinin
Evaluation of HQ® Matrix Medical Wound Dressing for Healing of Donor Site Wounds
Condition: Donor Site Wound
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety and effectiveness of HQ® Matrix Medical
      Wound Dressing for repair of donor site wounds. Half of participants will receive HQ® Matrix
      Medical Wound Dressing, while the other half will receive Sidaiyi® wound dressing.
    

Detailed description: 
      HQ® Matrix Medical Wound Dressing is a transparent, non-porous, pliable, gas-permeable, and
      waterproof film dressing which is comprised of silk fibroin protein of the Bombyx mori (B.
      mori) silkworm. It is intended to provide a moist, gas-permeable and sterile environment to
      facilitate the normal wound healing process. It is used in the management of non-infected
      skin defects and various dermal wounds.

      Sidaiyi® wound dressing (Suzhou Soho Biomaterial Science and Technology Co., Ltd, Suzhou,
      China) is a CFDA approved (Su2012-2640182), silk fibroin-based, two-layered spongy dressing.
      Upon the silk fibroin spongy dressing layer is a membrane made of medical silicone. It is
      used in the management of partial- and full-thickness wounds, donor site wounds and burns.
      Currently, it is the sole silk fibroin biomaterial for wound healing that has received
      regulatory approval worldwide.
    

Intervention name(s): HQ® Matrix Medical Wound Dressing; Sidaiyi® wound dressing
Intervention type(s): Device; Device
Other intervention name(s): HQ® Matrix; Sidaiyi®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Tablet Versus JNJ-42756493 Capsule in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of JNJ-42756493 oral
      dose of capsule (reference) versus tablet (test) in healthy participants.
    

Detailed description: 
      This is a Phase 1, randomized (study drug assigned by chance), open-label (all people know
      the identity of the intervention), 2 way crossover (method used to switch participants from
      one study group change to treatment group), single-dose study in healthy participants. The
      study will consist of 3 phases: Screening Phase (Day -21 to Day -2), Treatment Phase
      (consists of 2 single-dose treatment period, either JNJ-42756493 capsule or JNJ-42756493
      tablet) and Follow-up Phase (12-14 days after last dose). All the eligible participants will
      be randomly assigned to 1 of the 2 treatment sequences to ensure that they receive both of
      the treatments, 1 in each period. Each treatment regimen will be separated by a washout
      period of at least 15 days. Blood samples will be collected for evaluation of
      pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of
      two dosage form of JNJ-42756493 (test and reference) will be evaluated primarily.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-42756493 Tablet; JNJ-42756493 Capsule; JNJ-61818549
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive 10 mg of JNJ-42756493 tablet as single oral dose on Day 1 of each treatment period.; Participants will receive 10 mg of JNJ-42756493 capsule as single oral dose on Day 1 of each treatment period.; Participants will JNJ-61818549, 100 microgram (mcg) intravenous infusion over 5 minutes, after 2 hours of administration of JNJ-42756493 tablet/capsule on Day 1 Treatment Period 1.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-42756493; JNJ-61818549
Impact of Decision Aids in Urogynecology
Condition: Pelvic Organ Prolapse; Stress Urinary Incontinence; Overactive Bladder
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Stress; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      To evaluate how patient knowledge and confidence in decision making can be impacted by shared
      decision making in common urogynecology conditions.
    

Detailed description: 
      The investigators will enroll patients seeing a specialist to discuss treatment of pelvic
      organ prolapse, overactive bladder and stress urinary incontinence in this pilot study. The
      study will evaluate the feasibility and acceptability of three decision aids designed to
      promote shared decision making conversations for these three condition. The investigators use
      a quasi-experimental design in which the investigators first enroll patients in the control
      arm and measure their outcomes. Then, the investigators enroll patients into the intervention
      arm and measure their outcomes. The investigators estimate that it will take about one month
      to recruit the control arm and one month to recruit the intervention arm. Patients will be
      surveyed after the clinic visit with a specialist and surveys will assess patients'
      knowledge, treatment preferences, shared decision making, decisional conflict and
      acceptability of the tool. A clinician survey will be administered and completed after each
      patient visit, that details how the physician felt about the length of the visit, how
      informed the patient was, and how far along they may be with their decision.
    

Intervention name(s): Pelvic organ prolapse decision aid; Stress urinary incontinence decision aid; Overactive bladder decision aid
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse; Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.; Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: A usual care arm was recruited first, then the intervention arm was recruited.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: shared decision making
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4041 in Healthy Volunteers
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, first-in-human (FIH), single-center, randomized, double-blind, placebo
      controlled, single ascending dose, sequential group study in healthy vasectomized male and
      female subjects of non-childbearing potential, aged 18 to 65 years.
    


Intervention name(s): AZD4041; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administration by Oral syringe; Administration by Oral syringe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; Tolerability; Pharmacokinetics; Healthy Volunteers
The Change of Gut Microbiota After Bowel Preparation and the Effect of Probiotics
Condition: Gut Microbiota; Bowel Preparation; Colonoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the relationship between the change of intestinal
      bacterial flora and the recovery, and the incidence of symptoms such as abdominal discomfort
      after colonoscopy. And the investigators will also analyze the effects of probiotics on the
      degree of change, recovery, and symptom development in intestinal flora.
    

Detailed description: 
      The investigators divided two groups. (total number = 100 subjects)

        1. with probiotics group - 50 subjects

             -  Participants included in this group will be taken probiotics for 1 month after
                bowel preparation for colonoscopy.

        2. without probiotics group - 50 subjects

             -  Participants included in this group will not be taken probiotics for 1 month after
                bowel preparation for colonoscopy.
    

Intervention name(s): Duolac
Intervention type(s): Drug
Intervention description(s): Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Gut microbiota; Colonoscopy; Bowel preparation; Probiotics
Brain Gut Axis Changes After Bariatric Surgery and Their Relationship to Weight Loss
Condition: Obesity; Bariatric Surgery Candidate
MeSH terms: Weight Loss
Study type: Observational

Summary: 
      Assessing the changes in the brain-gut axis after weight loss surgery and their relationship
      with weight loss and changes in eating behaviors.

      Obese women undergoing weight loss surgery will be recruited to participate in the study.
      These individuals will undergo a screening visit and 4 study visits. The study visits will
      occur before, and at 1-, 6- and 12 months after the weight loss surgery. Each study visit
      will include evaluation of brain function (fMRI), anthropometrics, blood and stool samples
      and eating behaviors questionnaires.
    

Detailed description: 
      Assessing the changes in the brain-gut axis after weight loss surgery and their relationship
      with weight loss and changes in eating behaviors.

      Obese women undergoing weight loss surgery will be recruited to participate in the study.
      These subjects will undergo a screening visit and 4 study visits. The study visits will occur
      before, and at 1-, 6- and 12 months after the weight loss surgery. Each study visit will
      include evaluation of brain function (fMRI), anthropometrics, blood samples (gut hormones,
      cytokines, metabolomics ) and stool samples (16S RNA and Metabolomics) and eating behaviors
      questionnaires (YFAS, TFEQ, food cravings/preferences scales, 3-day food food intake records)

      Primary outcomes: weight loss after surgery and changes in eating behaviors scales (YFAS,
      TFEQ) , metabolomics, appetite related hormones and gut microbiome (16S RNA) Secondary
      outcomes: changes in brain function (fMRI/MRS), diet (3-day food intake records) and
      inflammatory markers.
    

Intervention name(s): Bariatric surgery
Intervention type(s): Procedure
Intervention description(s): Laparoscopic bariatric surgery including gastric bypass and sleeve gastrectomy
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will include obese women undergoing bariatric surgery as part of standard medical care.
      
Biospecimen description: 
      Stool samples for 16S RNA analysis