bioihbjkbjnl/mcl2 huggingface dataset:
Sugammadex vs Placebo to Prevent Residual Neuromuscular Block
Condition: General Surgery
MeSH terms: Delayed Emergence from Anesthesia
Intervention: Sugammadex; Placebo
Intervention description: Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.; Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Postoperative respiratory depression; Neuromuscular Agents

Summary:

      The study is designed to determine whether patients who receive sugammadex immediately after
      tracheal extubation will exhibit a decrease in the incidence of postoperative residual
      paralysis and an associated decrease in the incidence of postoperative respiratory
      depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing surgery with general anesthesia

          -  Patients weighing > or = 80 pounds

          -  Patients not intubated prior to surgery

          -  Patients who are able to give informed consent

        Exclusion Criteria:

          -  Patients unable to give informed consent.

          -  Patients whose condition will not allow for placement of the electrode PadSet of
             ExSpiron

          -  Patients who are anticipated to remain intubated in recovery period.
A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera/Rituxan]; Methotrexate
Intervention description: 1000mg iv on days 1 and 15; 10-25mg/week
Intervention MeSH terms: Rituximab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This single arm study will measure the effect of MabThera in combination with methotrexate on
      the progression of synovitis, the extent of bone marrow edema, and the number of erosions in
      the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients
      will receive MabThera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of
      10-25mg/week methotrexate throughout the duration of the study. Further courses of MabThera
      will be provided to eligible patients. MRI will be performed 1-2 weeks before treatment
      initiation, and repeated 1 and 6 months after the first MabThera infusion. The anticipated
      time on study treatment is 1-2 years, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age;

          -  rheumatoid arthritis for >=3 months and <=10 years;

          -  inadequate response to methotrexate (12.5-25mg/week) for >=3 months;

          -  evidence of erosive disease and/or clinical synovitis in a signal joint.

        Exclusion Criteria:

          -  autoimmune rheumatic diseases other than RA;

          -  surgical operations on bones/joints in 12 weeks prior to baseline visit;

          -  concomitant treatment with biologic agents;

          -  previous treatment with more than one biologic agent approved for RA, or with
             cell-depleting therapies.
CO2 Versus Air Insufflation for Single-balloon Enteroscopy
Condition: Intubation Depth
Intervention: CO2 insufflation regulator; Air insufflation
Intervention description: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.; The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Single-Balloon Enteroscopy

Summary:

      Small-balloon enteroscopy is a novel endoscopy system for examination of the deep small
      intestine.Initial reports indicated that CO2 was effective during the colonoscopy
      ,ERCP(endoscopic retrograde cholangiopancreatography) and DBE(double-balloon enteroscopy)
      examination, but it is still uncertain to the SBE(single-balloon enteroscopy) procedure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients referred for SBE at the trial centre

        Exclusion Criteria:

          -  Age under 18 years, over 75 years Refusal of participation GIST(gastrointestinal
             stromal tumor), apparent tumor, post surgery Crohn's disease, Intestinal obstruction,
             stenosis, radiation enteritis Severe cardiopulmonary dysfunction
the Analgesic Duration of Dexmedetomidine Compared to Dexamethasone as Adjuncts to Single Shot Interscalene Block
Condition: Opioid Use, Unspecified
Intervention: Ropivacaine; Dexmedetomidine; Dexamethasone
Intervention description: local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery; local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery; local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
Intervention MeSH terms: Dexamethasone; Dexmedetomidine; Ropivacaine; Anesthetics
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 105.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: post operative pain, Dexmedetomidine, Regional anesthesia

Summary:

      The purpose of the study is to determine if perineural dexmedetomidine can provide increased
      prolongation of analgesia when compared to perineural dexamethasone in patients receiving
      regional block for shoulder surgery. If so, dexmedetomidine may serve as a superior adjunct
      to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.
    

Eligibility criteria:

        Inclusion Criteria :

          -  ASA 1 and 2

          -  18-60 years old

          -  Patients scheduled for ambulatory arthroscopic or open surgery

        Exclusion Criteria:

          -  ASA 3 and 4

          -  Pre-existing pain disorder

          -  Regular consumption of chronic pain medication

          -  Anatomical abnormalities of upper extremity

          -  Known allergy or hypersensitivity to Ropivacaine or other amide local anesthetics

          -  Known allergy to dexmedetomidine

          -  Coagulopathy

          -  Uncontrolled Diabetes
Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants
Condition: Hepatitis B; Tetanus; Poliomyelitis; Diphtheria; Haemophilus Influenzae Type b; Acellular Pertussis
MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis
Intervention: Infanrix™ hexa
Intervention description: Intramuscular, three doses
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infant; First nation; Aboriginal; Canada

Summary:

      This study will evaluate GSK Biologicals' DTPa-HBV-IPV/Hib vaccine given as a three-dose
      primary vaccination course at 2, 4 and 6 months of age, in terms of safety and immunogenicity
      in different population of infants residing in Canada.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that their parent/guardian can and will comply
             with the requirements of the protocol should be enrolled in the study.

          -  A male or female between, and including, 6 and 12 weeks of age at the time of the
             first vaccination.

          -  Born after a gestation period of 36 to 42 weeks inclusive.

          -  Healthy subjects as established by medical history before entering into the study.

          -  Written informed consent obtained from the parent or guardian of the subject.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product within 30 days preceding the
             first dose of study vaccine, or planned use during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs from
             birth until first primary vaccination dose..

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period, in which the subject has been or will be exposed to an investigational or a
             non-investigational product.

          -  Major congenital defects or serious chronic illness.

          -  Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis,
             hepatitis B and/or Hib vaccination or disease.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  The following condition is temporary or self limiting and a subject may be vaccinated
             once the condition has resolved and no other exclusion criteria are met:

          -  Current febrile illness or axillary temperature of ≥ 37.5 ºC or other moderate to
             severe illness within 24 hours of study vaccine administration.
Long-Acting Reversible Contraception
Condition: Contraception
Intervention: DMPA; oral contraceptives; Implanon®; ParaGard®; Mirena®
Intervention description: Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.; Oral contraceptives (any variety of formulations are permitted); Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel); Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface); Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)
Intervention MeSH terms: Contraceptive Agents; Etonogestrel; Contraceptives, Oral
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Partially randomized patient preference trial
Masking: None (Open Label)
Enrollment: 916.0
Sex: Female
Minimum age: 18 Years
Maximum age: 29 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: AE-adverse event; FDA-(U.S.) Food and Drug Administration; GCP-Good Clinical Practice guidelines; ICH-International Committee on Harmonisation; IRB-Institutional Review Board; IU-International units; mg-milligram(s); mm3-cubic millimeter(s); LARC-Long-Acting reversible contraception; PPCNC-Planned Parenthood of North Carolina; SAE-serious adverse event; SARC-Short-Acting reversible contraception; µg-microgram; ULN-upper limit of the normal range; SubQ-subcutaneous

Summary:

      In the proposed study, women aged 18-29 seeking oral or injectable contraception will be
      offered an opportunity to try LARC instead; the FDA-approved options include two types of
      intrauterine products and one type of subdermal contraceptive implant. Over a 24 month
      period, the experiences of LARC users will be compared to the experiences of those opting for
      their initial short-acting method.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 to 29 years of age;

          -  sexually active;

          -  seeking oral or injectable contraception;

          -  working cell phone;

          -  working email account;

          -  willingness to be contacted by the clinic staff or study coordinators; and,

          -  willingness to complete questionnaires.

        Exclusion Criteria:

          -  currently pregnant;

          -  previous use of a long-acting reversible contraceptive (LARC) method; and,

          -  medical contraindications for oral contraceptives and injectables.
Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis
Condition: Osteoarthritis; Shoulder Pain
MeSH terms: Osteoarthritis; Shoulder Pain
Intervention: PRP; Hyaluronic Acid; Ultrasound
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This study seeks to expand the current literature in demonstrating potentially efficacious,
      conservative treatments in the management of glenohumeral osteoarthritis (OA) and will
      compare ultrasound-guided injections of hyaluronic acid vs. platelet-rich plasma. We aim to
      obtain information measuring potential benefits of these interventions and to observe for any
      adverse events.
    

Eligibility criteria:

        Inclusion Criteria:

          -  English speaking/literate

          -  Age 18-100 years

          -  Visual analog score pain >= 5

          -  Greater than or equal to 3 months of pain after onset of symptoms that has failed
             conservative treatments

          -  Confirmation of glenohumeral OA via routine imaging (MRI and x-ray; must be recent and
             within the past year)

          -  Transient relief of symptoms after diagnostic intra-articular injection into the
             glenohumeral joint

        Exclusion Criteria:

          -  Non-English speaking/illiterate

          -  Painful active, concurrent cervical spine conditions

          -  Current non-steroidal anti-inflammatory drug (NSAID) use

          -  History of taking coumadin or similar anticoagulant, have a known coagulopathy,
             bleeding dyscrasia, or platelet count < 150,000/cubic mm

          -  Allergic reaction to poultry or previous viscosupplementation

          -  Involved in workers' compensation or active litigation involving affected shoulder

          -  Inability to refrain from NSAID use for 5 days prior to and 6 weeks after injection

          -  History of corticosteroid injection to affected shoulder within the last 3 months

          -  History of viscosupplementation or platelet-rich plasma to affected shoulder within
             the last 6 months

          -  Presence of acute fracture

          -  History of shoulder tumor

          -  Known uncontrolled systemic illness (uncontrolled diabetes, human immunodeficiency
             virus, vasculitis, autoimmune/inflammatory disease)

          -  Psychiatric and somatoform disorders
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
Condition: End-stage Renal Failure; Graft Rejection
MeSH terms: Kidney Failure, Chronic
Intervention: Tacrolimus (Kidney transplant maintenance immunosuppression); Kidney transplant maintenance immunosuppression
Intervention description: Standard-release Tacrolimus 1 to 20mg daily in two divided doses to maintain trough drug levels 6-9ng/ml; Prolonged-release Tacrolimus 1 to 20mg daily in a single am dose adjusted to trough drug levels 6-9ng/ml
Intervention MeSH terms: Tacrolimus
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Kidney transplant; Rejection; Adherence; Quality of life

Summary:

      The current anti-rejection drug regime for kidney transplant recipients in use at the West
      London Renal & Transplant Centre (WLRaTC) consists of induction therapy with the very potent
      monoclonal antibody Campath 1-H (Alemtuzumab) followed by long-term maintenance with the
      Calcineurin inhibitor Tacrolimus

      The recent development (and licensing in the UK) of an extended-release, once daily
      formulation of Tacrolimus holds out the promise of simpler drug regimes for our patients. In
      the context of our current successful use of Tacrolimus monotherapy maintenance after Campath
      1-H induction, the extended-release Tacrolimus formulation will enable us to offer a regime
      where the only long-term immunosuppressive treatment that most of our patients need will be a
      single drug, taken once a day.

      The investigators wish to assess the efficacy of such a regime in a structured comparison
      with our current protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Live donor kidney transplant recipients

          -  heart-beating-Deceased donor kidney transplant recipients

          -  Patients suitable for induction therapy with Alemtuzumab

        Exclusion Criteria:

          -  Recipients of Non-heart-beating deceased donor kidney transplants

          -  Recipients of simultaneous kidney/pancreas transplants

          -  ABO incompatible/desensitized transplant recipients

          -  Positive flow cross-match/desensitized transplant recipients

          -  Patients with heavy prior exposure to myelosuppressive therapy

          -  Patients with previous malignancy

          -  Patients with HIV,Hepatitis-C, or Hepatitis-B infection
Treatment of Peripheral T-cell Lymphoma
Condition: Peripheral T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Intervention: GDPT regimen; CHOP regimen
Intervention description: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.; CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 14 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Peripheral T-cell lymphoma;chemotherapy;; RR;PFS;OS

Summary:

      The purpose of this study is to evaluate the efficacy and safety of GDPT regiment
      (gemcitabine，cisplatin,Prednisone ,Thalidomide

      ) for patients with Peripheral T-cell lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

        Age range 14-70 years old; ECOG performance status 0-2; Estimated survival time > 3 months
        Histological confirmed Peripheral T cell lymphoma None of chemotherapy or radiotherapy has
        been previously used None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl,
        neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤
        1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L,
        serum plasminogen is normal (Inclusion Criteria of 1,3,6 groups ) At least one measurable
        lesion None of other serious diseases, cardiopulmonary function is normal Pregnancy test of
        women at reproductive age must be negative Patients could be followed up None of other
        relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy
        except anti-bone metastasis therapy and other symptomatic treatments.

        volunteers who signed informed consent.

        Exclusion Criteria:

        Disagreement on blood sample collection Patients allergic of any of drug in this regimen or
        with metabolic disorder Pregnant or lactating women Serious medical illness likely to
        interfere with participation Serious infection Primitive or secondary tumors of central
        nervous system Chemotherapy or radiotherapy contraindication The evidence of CNS metastasis
        History of peripheral nervous disorder or dysphrenia patients participating in other
        clinical trials patients taking other antitumor drugs patients estimated to be unsuitable
        by investigato