bioihbjkbjnl/mcl2 huggingface dataset:
DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric
      sensing compared with customary electrical isolation tests and Adenosine infusion at the end
      of the procedure. Furthermore, safety, usability and clinical applicability of the system for
      guided AF ablation will be confirmed.
    

Detailed description: 
      Prospective, single-center, non-randomized, non-blinded, open label, and single arm study.

      All procedures will be performed under CARTO-3 guidance for the treatment of atrial
      fibrillation (AF). The EPD D700 system will be used in-tandem, to record pre-, during and
      immediate post-ablation tissue characteristics and compute likelihood of lesion transmurality
      and permanency. Additionally, D700 system safety, feasibility, usability and clinical
      applicability will be documented.

      The entire procedure will be conducted as customary, using standard and approved
      off-the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation
      catheters, RF generator and recording system), in a completely clinically independent manner
      from the EPD D700 system. The physician will neither use nor rely on any of the D700 system
      output for clinical decision making and will be blinded to the D700 lesion assessment
      forecasts. After 30 days following the initial procedure, a repeated procedure will be
      performed for gap detection and its results will be correlated with the D700 predictions.
    

Intervention name(s): D700 System
Intervention type(s): Device
Intervention description(s): Atrial Fibrillation Ablation Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
How Improvement in Control of Diabetes Influences the Production of a Hormone Produced in the Gut Which Improves the Release and Action of Insulin.
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The study is aimed at Type 2 Diabetics who are taking Metformin, but whose Diabetes remains
      poorly controlled. There are two additional medications already in use, Glimepiride and
      Sitagliptin will be compared to assess levels of improvement in Diabetes control.
    


Intervention name(s): Glimepiride; Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): 3mg oral tablet.; 100mg oral tablet.
Other intervention name(s): Amaryl.; Januvia.
Intervention MeSH terms: Sitagliptin Phosphate; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; GLP1; DPP4
Safety, Tolerability, Pharmacokinetics & Pharmacodynamics of Toripalimab for Patients With Recurrent Malignant Lymphoma
Condition: Malignant Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the safety and tolerability of JS-001 in subjects with
      recurrent malignant lymphoma, and to evaluate its preliminary efficacy.

      The secondary objectives are to: 1) characterize the single-dose and multi-dose
      pharmacokinetic (PK) profile of JS-001, 2) characterize the immunogenicity of JS-001; 3)
      assess the dose-efficacy relationship of JS-001 single agent, and 4) preliminarily evaluate
      biomarkers associated with the efficacy of JS-001.
    


Intervention name(s): Toripalimab
Intervention type(s): Biological
Intervention description(s): Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS001. Subjects will be assigned to a dose schedule in the order of study entry.
Other intervention name(s): JS001, TAB001
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunotherapy; check point inhibitor; PD-1 antibody; phase 1 trial; Malignant Lymphoma
Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia
Condition: Acute Lymphoid Leukemia Relapse; Acute Lymphoid Leukemia Relapse After Bone Marrow Transplant
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited
      Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with
      etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and
      safety of this combination regimen to treat children with high risk relapsed or refractory
      acute lymphoblastic leukemia (ALL).
    

Detailed description: 
      I.3 Primary Objectives :

      To determine the MTD of escalating doses of clofarabine starting from 20 mg/m2/day to 40
      mg/m2/day from day 1 to day 5, as a replacement of cytarabine as part of a combination of
      etoposide, asparaginase, mitoxantrone and dexamethasone (VANDA regimen).

      I.4 Secondary Objectives :

        1. To determine the safety and tolerability of clofarabine when used in combination with
           etoposide, asparaginase, mitoxantrone and dexamethasone (VANDA regimen) and determine
           the duration, seriousness, and relationship of adverse events that occur during the
           treatment and follow-up periods ; we search DLT

        2. To determine the Overall Response rate (OR) (Complete Remission + Complete Remission
           without platelet's normalization) of clofarabine plus etoposide ,asparaginase,
           mitoxantrone and dexamethasone (VANDA regimen) in pediatric patients with refractory or
           relapsed ALL at the established clofarabine RP2D.

        3. To document the rate of Partial Response[s] in the study population

        4. To document time-to-event parameters, including duration of remission, Event Free
           Survival (EFS), 4-month EFS, and overall survival (OS).
    

Intervention name(s): Clofarabine
Intervention type(s): Drug
Intervention description(s): escalating doses of clofarabine starting from 20 mg/m2/day to 40 mg/m2/day from day 1 to day 5 used in association with etoposide, asparaginase, mitoxantrone and dexamethasone
Other intervention name(s): etoposide,; asparaginase,; mitoxantrone; dexamethasone
Intervention MeSH terms: Dexamethasone; Etoposide; Asparaginase; Mitoxantrone; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute lymphoblastic leukemia; relapse; childhood; clofarabine
NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy
Condition: Breast Cancer
Study type: Observational

Summary: 
      Nipple areolar-complex (NAC) sparing mastectomy, extending the concept of skin-sparing
      mastectomy, allows to leave the nipple-areola complex intact and to provide a better cosmetic
      result. Large operable T2-T3 breast cancer (BC), treated with neoadjuvant chemotherapy, may
      theoretically appear suitable for this surgical option, alternative to conventional
      mastectomy or breast conserving surgery in case of unfavorable size of the breast, when a
      good response to neoadjuvant chemotherapy has been achieved.
    

Detailed description: 
      From January 2009 to May 2013, 422 BC patients were progressively accrued to NAC-sparing
      mastectomy, of which 361 invasive BC patients underwent NAC-sparing mastectomy as first
      treatment (NAC-group), whereas 61 T2-T3 invasive BC patients underwent surgery after primary
      chemotherapy (NAC-PC group). 151 BC patients underwent primary chemotherapy and conventional
      mastectomy (PC group) from 2004 to 2009, has been evaluated as comparative group respect to
      NAC-PC group.

      Using propensity score matching, local disease-free survival (LDFS) in NAC-PC patients was
      first compared with that in PC patients.

      The NAC-PC cohort was then compared to NAC patients in terms of LDFS using two different
      matching criteria, one with tumor size after neoadjuvant chemotherapy and one with tumor size
      before neoadjuvant chemotherapy as balancing covariates.
    

Intervention name(s): NAC-sparing mastectomy; conventional mastectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): patients treated with mastectomy with conservation of nipple-areola complex; patients treated with mastectomy without conservation of nipple-areola complex
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both the population of patients treated with neoadjuvant chemotherapy (NAC-PC and PC
        groups) were T2-T3 N0-N1 breast cancer.

        The population of patients who underwent NAC-sparing mastectomy as primary therapy
        (NAC-group) were T1-T3 N0-1 M0 breast cancer patients.
Pharmacology of Insulin Injected With Jet-Injection
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to compare the pharmacological profile of insulin administered
      with jet-injection with that of insulin injected with a conventional insulin pen.
    


Intervention name(s): jet injector (SQ pen/Novopen III); jet injector (SQ pen/Novopen III)
Intervention type(s): Device; Device
Intervention description(s): The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.2 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector.; The rapid-acting insulin analogue insulin aspart (Novorapid®), at a dose of 0.4 units per kg body weight, will be injected subcutaneously. On one experimental day insulin will be injected with the jet injector and placebo with the conventional insulin pen. On the other experimental day insulin will be injected with the conventional insulin pen and placebo with the jet injector.
Other intervention name(s): SQ pen; Novopen III; SQ pen; Novopen III
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmacokinetic profile; Pharmacodynamic profile; insulin; jet injector
Study to Evaluate Benefit of ProbioSatys™ on Weight Reduction in Overweight Subjects
Condition: Overweight; Weight Loss
MeSH terms: Overweight; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The study aims to evaluate the effects of ProbioSatys™ on body weight and related parameters
      in overweight subjects during a 12-week consumption period. In addition, tolerability and
      safety of ProbioSatys™ will be assessed.
    

Detailed description: 
      ProbioSatys™ is a probiotic nutritional solution containing a commensal Enterobacteriaceae
      food grade strain, Hafnia alvei 4597. The microbiome is known to play a crucial role in body
      weight management and metabolic disease. ProbioSatys™ mechanism of action relies on bacterial
      metabolites that send local and central signals via the gut-brain axis by molecularly
      mimicking satiety hormones involved in appetite regulation.

      Numerous ProbioSatys™pre-clinical studies indicate that consumption of the strain leads to
      body weight loss based on food intake reduction, but also improvement of body composition
      (increase of lean mass/fat mass ratio), and improvement of glucose metabolism (oral glucose
      tolerance test, and fasted glycemia).

      The present study aims to evaluate the effects of ProbioSatys™ on body weight and related
      parameters in overweight subjects during a 12-week consumption period. In addition,
      tolerability and safety of ProbioSatys™ will be assessed.
    

Intervention name(s): ProbioSatys™; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): One capsule, twice a day, is to be orally taken with 100 mL of water during each breakfast and lunch (approx. 5 minutes after starting eating), total 2 capsules per day.; One capsule, twice a day, is to be orally taken with 100 mL of water during each breakfast and lunch (approx. 5 minutes after starting eating), total 2 capsules per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Probiotics; Microbiome; Microbiota; Hafnia alvei; Overweight; Food intake; Appetite regulation; Satiety; Weight loss; Glucose Metabolism; Glycemia; Enterobacteriaceae; Gut-brain axis; Molecular mimicry
Effects of Hypnosis on Skin Temperature
Condition: Hypnosis; Healthy Volunteers
Study type: Observational

Summary: 
      Hypnotic glove anesthesia is a hypnosis technique wherein the patient, following the
      suggestions of the hypnotherapist, is mentally capable to create a loss of sensation in areas
      of the hand that would be covered by a glove. We investigated the effects of hypnotic glove
      anesthesia on skin temperature measured by thermography.
    

Detailed description: 
      After 20 min installation and temperature equilibration (T0), the subject skin temperature
      was recorded in 5 regions of both hands (1 = distal hand, 2 = proximal hand, 3 = wrist, 4 =
      distal forearm, 5 = proximal forearm) using infrared thermography.

      After 10 min of latency, skin temperature was recorded again in both hands (T1).

      A first noxious stimulus (NOX1) is then applied by the hypnotherapist by pinching the webbing
      between the thumb and index fingers of the dominant hand between the thumb and the index.
      Pain intensity is assessed on a 0-10 (0 = no pain, 10 = maximal pain imaginable) numerical
      rating scale (NRS1).

      The hypnotic glove is then mentally created by the subject on his dominant hand following the
      suggestions of the hypnotherapist (T2). To assess the efficacy of the hypnotic glove, a
      second noxious stimulus (NOX2) is applied similarly to NOX1 and the NRS was recorded (NRS2).

      The subject is then invited to mentally wear off the glove (T3). Skin temperature is then
      recorded in both hands, and a third noxious stimulus (NOX3) is applied similarly to NOX1 and
      NOX2 to verify the disappearance of hypnotic anesthesia.

      A last record of skin temperature in both hands is performed 5 min after the glove is
      withdrawn (T4).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
      
Keywords: Hypnosis; Anesthesia; Suggestion; Thermography
Cryotherapy and Joint Biomechanics During Running
Condition: Musculoskeletal Injury
Study type: Interventional

Summary: 
      The purpose of this study is to determine the immediate effects of cryotherapy on the lower
      extremity biomechanics during running.
    

Detailed description: 
      Cryotherapy or cold therapy has widely been used as a treatment modality in both acute and
      chronic injuries. It is believe that the application of cryotherapy can help to decrease
      pain, muscle soreness, soft tissue swelling, and cause vasoconstriction of blood vessels
      reducing heat loss. The nerve conduction velocity and muscle-spindle firing rate also
      decreases with cryotherapy, which results in changes in proprioception acuity. Cryotherapy
      has also been used prior to exercise (pre-cooling) to improve endurance activities. However,
      given the possible detrimental effects of cryotherapy on proprioception acuity, the use of
      this treatment modality prior to exercise could pose an increased risk of musculoskeletal
      injury. The effects of cryotherapy on lower extremity biomechanics during athletic movements
      is poorly understood despite the wide use among physiotherapists, athletic therapists and
      clinicians. Therefore, the purpose of this investigation is to determine the effects of cold
      water immersion on lower extremity biomechanics during running. The investigators hypothesize
      that cryotherapy as a form of treatment can increase the load in the lower extremity joint
      during gait biomechanics.
    

Intervention name(s): Cryotherapy; Control
Intervention type(s): Other; Other
Intervention description(s): The subjects will be exposed to a cold (~ 12° C) water immersion tub at the umbilical level for 20 minutes.; The subjects will be exposed to a non-cold (~ 26° C) water immersion tub at the umbilical level for 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
Oral Nadolol for the Treatment of Adults With Mild Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to confirm previous observations in asthmatics that chronic
      nadolol treatment reduces asthmatic airway hyper-responsiveness.
    


Intervention name(s): nadolol
Intervention type(s): Drug
Intervention description(s): Nadolol, oral taken daily, doses will be escalated every two weeks over 13 weeks following a 2 week run-in.
Other intervention name(s): Corgard
Intervention MeSH terms: Nadolol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; hyperresponsiveness
Estimation Of Effect Of Rifampin On Pharmacokinetics Of Crizotinib In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of multiple doses of Rifampin on the
      single dose pharmacokinetics of Crizotinib in healthy volunteers.
    


Intervention name(s): crizotinib; rifampin; crizotinib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment A: a single 250-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 2 × 100-mg Immediate Release Tablets.; Treatment B: 600 mg once a day doses of rifampin will be orally administered after overnight fasting from Day 1 to Day 14.; Treatment B: A single 250-mg dose of crizotinib will be administered in the fasted state on Day 9 as 1 × 50-mg and 2 × 100-mg Immediate Release Tablets.
Intervention MeSH terms: Rifampin; Crizotinib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: crizotinib; healthy volunteers; rifampin; pharmacokinetics; single dose
Effect of Different Infusion Volume on Perioperative Bladder and Blood Volume in Patients Undergoing Daytime Surgery.
Condition: Cholecystolithiasis and Thyroid Nodule
MeSH terms: Thyroid Nodule; Cholecystolithiasis; Cholelithiasis; Gallstones
Study type: Interventional

Summary: 
      The objective of the trial was to explore the effect of different infusion volume on
      perioperative bladder and blood volume in patients undergoing daytime surgery assisted by
      bladder and vascular ultrasound and transthoracic echocardiography.
    

Detailed description: 
      The objective of the trial was to evaluate the effects of different infusion volume of
      Ringer's solution acetate (2 ml/kg,8ml/kg, 16ml/kg) on bladder volume,
      hemodynamics,transthoracic echocardiography and vascular ultrasound including the inferior
      vena cava(IVC) and the right subclavian vein(SCV) diameter and the IVC and SCV collapsibility
      index in patients undergoing daytime surgery through a randomized controlled clinical study,
      so as to provide better guidance for clinical transfusion avoiding bladder catheterization .
      The patients in this trial were visited before induction and discharge from the
      postanaesthesia .We also collected the first time and times of micturition and whether the
      patients have the dysuria.
    

Intervention name(s): Ringer's solution acetate; Ringer's solution acetate; Ringer's solution acetate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.; Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.; Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Doppler Ultrasonography Assessed Bladder and Blood Volume
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of PCSK9 Inhibitor AK102 in Healthy Subjects
Condition: Hypercholesterolaemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human,randomized, double-blind, placebo-controlled, single dose
      escalation, phase 1 study to evaluate the safety, tolerability, PK/PD and immunogenicity of
      AK102 administered subcutaneously in healthy subjects. Subjects will be randomized into 4
      planned single dose escalation cohorts or placebo cohort.
    


Intervention name(s): AK102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AK102 single dose administered subcutaneously; Placebo single dose administered subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Phase 1 Study To Evaluate The Pharmacokinetics (PK), Safety, And Bioavailability Of A Modified-Release (MR) Formulation Of Tofacitinib In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will explore the drug behavior and safety following single doses of tofacitinib
      modified-release (MR) 11 mg and MR 22 mg in healthy volunteers.
    


Intervention name(s): tofacitinib modified-release (MR) formulation; tofacitinib modified-release (MR) formulation
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.; A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; relative bioavailability; modified release; tofacitinib; CP-690; 550; pharmacokinetic