bioihbjkbjnl/mcl2 huggingface dataset:
Rapid Evaluation of Pandemic H1N1 Influenza Vaccine in Adults Receiving Seasonal Influenza Vaccine
Condition: Influenza; H1N1 2009 Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the safety and effectiveness (immune response) to a
      licensed H1N12009 influenza vaccine in adults when given at the same time or prior to the
      seasonal influenza vaccine. The study will enroll 300 adults (ages 20-59 years). Participants
      will be randomized into 2 groups. One group will receive one dose of a licensed H1N1 vaccine
      and one dose of the seasonal influenza vaccine at the same time; the second group will
      receive the seasonal influenza vaccine 3 weeks after receiving the licensed H1N12009
      influenza vaccine. Study procedures include: medical history, blood samples and completing a
      memory aid. Participants will be involved in study related procedures for approximately 3-6
      weeks depending upon the group assignment.
    

Detailed description: 
      The objectives of this study are two-fold:

        1. To evaluate the safety and immunogenicity of H1N12009 influenza vaccine in a convenience
           sample of adults, soon after the pandemic vaccine becomes available so as to inform the
           subsequent use of vaccine in public programs.

        2. To evaluate the compatibility of co-administered H1N12009 pandemic vaccine and seasonal
           TIV vaccine in the same group of subjects, as the option of co-administration would be
           useful for public programs.
    

Intervention name(s): Arepanrix, Vaxigrip 2009/2010; Arepanrix, Vaxigrip 2009/2010
Intervention type(s): Biological; Biological
Intervention description(s): Group A: Single dose of Arepanrix and single dose of Vaxigrip 2009/2010 given concurrently; Group B: Single dose of Vaxigrip 2009/2010 given 3 weeks after single dose of Arepanrix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccine; H1N1; influenza; H1N1 influenza vaccine; influenza vaccine; seasonal Influenza
A Phase Ⅰa Study of Remimazolam Tosylate in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and compare the Pharmacokinetics/Pharmacodynamics
      and safety of Remimazolam Tosylate with midazolam in healthy volunteers
    


Intervention name(s): Remimazolam Tosylate; Midazolam
Intervention type(s): Drug; Drug
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Remimazolam Tosylate; Phase Ⅰ study; Health
Study of the Effect of Lactisole on the Intestinal Glucose Uptake
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study of the effect of lactisole on glucose uptake
    


Intervention name(s): lactisole; placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): administration of lactisole followed by placebo; administration of placebo followed by lactisole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Healthy volunteers
A Bioequivalence Study Of AG-013736 Tablets In Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis of this study is that one 5 mg tablet of axitinib has similar drug
      concentrations in plasma compared to five 1 mg tablets of axitinib after oral dosing.
    


Intervention name(s): AG-013736; AG-103736
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B); single oral dose of film coated immediate release tablet (one 5-mg tablet for Treatment A and five 1-mg tablets for Treatment B)
Other intervention name(s): axitinib; axitinib
Intervention MeSH terms: Axitinib
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence
Withdrawal of Immunosuppression in Recipients of Face and Extremity Transplants
Condition: Vascularized Composite Allotransplantation
Study type: Interventional
Phase: Phase 1

Summary: 
      Many patients suffer from devastating injuries to vascularized composite tissues.
      Vascularized composite tissues are blocs of functional tissue that can contain multiple
      tissue types such as bone, muscle, nerves, blood vessels, tendons, ligaments, and others.
      Examples of patients with severe vascularized composite tissue defects include limb amputees,
      patients with third-degree burns to the face or extremities, soldiers with
      improvised-explosive-device blast injuries to the face, and others. These patients cannot be
      helped satisfactorily with conventional reconstructive surgery; however, recently
      vascularized composite allotransplantation (VCA) such as transplantation of faces and limbs
      became available to this patients. Unfortunately, at this juncture, patients who receive VCA
      must submit to life-long regime of immunosuppressant drugs with serious side effects such as
      infection, renal toxicity and cancer. Immune tolerance is the absence of a destructive immune
      response from the recipient's body to the transplant, while otherwise maintaining sufficient
      immune function to fight infections and other threats. Transplant recipients with immune
      tolerance do not need to take immunosuppression drugs. The investigators believe that they
      can achieve immune tolerance in recipients of face and limb transplants.
    


Intervention name(s): Interleukin-2
Intervention type(s): Biological
Other intervention name(s): Aldesleukin, proleukin
Intervention MeSH terms: Aldesleukin; Interleukin-2
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Single Shot vs Continuous Interscalene Block for Rotator Cuff Repair
Condition: Pain; Rotator Cuff; Surgery
Study type: Observational

Summary: 
      1. Rotator cuff have painful post surgery recovery.

        2. Single shot interscalene with oral analgesics may or may not be enough

        3. Continuous nerve block may be too much for the surgery

        4. The idea is to compare two techniques to see if the two techniques can improve patient
           pain control and satisfaction.
    

Detailed description: 
      After consent patients will be randomized to one of the two groups: Control Group or the
      Experimental Group. Patients will be blinded to the group assignment.

      In the Control Group the patient will be given single shot interscalene block using
      ultrasound technique following established guidelines. The procedure will be done after
      starting intravenous access and placing standard anesthesia monitors (EKG, Blood Pressure
      Cuff and Pulse-Ox) on the patient. Following accepted aseptic guidelines the nerves will be
      visualized at the base of the neck using ultrasound machine. Once proper nerve roots or
      trunks visualized 3 mg/kg of 0.5 % bupivacaine will be injected in small blouses.

      In the Experimental Group, after placement of monitors, the nerves will be visualized using
      ultrasound machine. There after a catheter will be placed. They subjects will be dosed using
      0.5% bupivacaine 3 mg/kg for the surgery via the catheter.

      The extent of block before the surgery will be evaluated at 30 minutes post injection.
      Surgery will be done with sedation. Conversion of anesthetic technique to general anesthesia
      will be considered failure of the technique to provide adequate surgical anesthesia.

      At the end of the case the patient will be taken to recovery and will be evaluated for pain.
      If patient is having pain of 3 or more then they will be treated as follows.

      In single shot group will be offered to be blocked again or treated with oral narcotics.

      In the catheter group patient will be dosed with 10 ml 1% lidocaine. If it fails to provide
      any relief then the catheter will be pulled back and another 10 ml1% lidocaine will be given.
      If still not effective then it will be replaced. Refusal of patient to replace the catheter
      will result in patient dropping out of the study.

      Working catheter will be left in place for at least 48 hrs. Patients will be allowed to take
      oral pain medicines as prescribed by their surgeons. The patient will be sent home with pain
      pump to continuously give them 0.125% bupivacaine at 5 ml per hr with an option to get extra
      dose of 5 ml q hr if needed. The pain control will be monitored by phone daily till catheter
      comes out.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All pateint undergoing arthroscopic rotator cuff surgrey and agreed to have regional block
        for pain control
      
Keywords: continuous block; single shot; interscalene; rotator cuff surgery
Upper Limb Task-Oriented Rehabilitation With Robotic Exoskeleton for Hemiparetic Stroke Patients
Condition: Cerebrovascular Accident (CVA); Chronic Disease; Stroke Rehabilitation
MeSH terms: Stroke; Chronic Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the effects of an assisted rehabilitation treatment
      through a robotic exoskeleton device on the functional recovery in a group of patients with
      hemiparesis from lesion of the first motor neuron (post-stroke), compared with a group of
      patients subjected to a conventional rehabilitation treatment. The patients enrolled in the
      study are chronic stroke injured with right hemiparesis of moderate to severe degree, by the
      system injury pyramid, never undergoing rehabilitation treatment with robots.
    


Intervention name(s): Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)
Intervention type(s): Device
Intervention description(s): RH-LEXOS is a robotic exoskeleton device to support the rehabilitation of stroke patients. This system is conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. Passive, assisted and active mobilization of upper arm is provided through the use of the exoskeleton robotic device within high intensive, repetitive, task-oriented exercises and an objective and reliable mean for monitoring patients' progress.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Robotics [H01.671.293.643]; Exoskeleton Device [E07.341]; Rehabilitation Research [H01.770.644.145.472]; Physical and Rehabilitation Medicine [H02.403.680]; Exercise Therapy [E02.779.483]; Patient Outcome Assessment [N05.715.360.575.575.399]
Health First-Study 2
Condition: Exercise Adherence; Sedentary Adults; Lifestyle; Traditional
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The current study was designed to investigate the influence of choice of exercise program on
      exercise adherence. The two exercise programs included 1) traditional exercise at a fitness
      centre or 2) lifestyle exercise-walking using a pedometer to track steps. Biological and
      psychological indicators were examined to investigate the effect of choice in a sample of
      sedentary adults.
    


Intervention name(s): choice of exercise program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; adherence; lifestyle; choice; autonomy
Topical Roflumilast in Adults With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of topical roflumilast on the reduction
      of atopic dermatitis lesions in adults with atopic dermatitis.
    


Intervention name(s): 0.5% Roflumilast Cream; Vehicle Cream
Intervention type(s): Drug; Drug
Intervention description(s): Roflumilast 0.5% cream; Roflumilast formulation vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atopic dermatitis
Study for Determine the Safety and Efficacy of Clostridium Botulinum Toxin Type A in Subjects With Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the Optimal dose for safety and efficacy in the
      treatment of cervical dystonia.
    


Intervention name(s): MT10109; BOTOX(Registered trade mark)
Intervention type(s): Biological; Biological
Intervention description(s): Botulinum toxin type A; Botulinum toxin type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single Ascending Dose Study of PRX002 in Healthy Subjects
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This single ascending dose study is to determine safety, tolerability, pharmacokinetics and
      immunogenicity of PRX002 in approximately 40 healthy subjects.
    


Intervention name(s): PRX002; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer; Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has 2 parts: dose finding and dose confirmatory.

      In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find
      out what dose of durvalumab administered as an infusion under the skin acts similarly to
      durvalumab administered into a vein. 24 participants with Non-Small Cell Lung Cancer will be
      enrolled for a 12 month treatment period and 3 months follow up

      In Part 2, the dose confirmation phase of the study, participants will receive the dose of
      durvalumab identified in Part 1 of the study. The goal of Part 2 will be to learn more about
      the way that the body processes durvalumab when administered as an infusion under the skin.
      Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled; additionally,
      up to 10 participants with Small Cell Lung Cancer (who will receive concurrent chemotherapy)
      will be enrolled for a 12 treatment period and a 3 month follow-up period.

      AstraZeneca has decided to stop further enrollment and the study was terminated when all
      patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical
      concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.
    


Intervention name(s): Durvalumab; Cisplatin; Carboplatin; Etoposide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Anti-PD-L1 antibody; Chemotherapy; Chemotherapy; Chemotherapy
Other intervention name(s): MEDI4736, IMFINZI
Intervention MeSH terms: Carboplatin; Etoposide; Durvalumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: imfinzi; durvalumab
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Repeat Doses of PF-06372865 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      multiple repeat oral doses of PF-06372865 in healthy adult subjects.
    


Intervention name(s): Placebo; PF-06372865
Intervention type(s): Drug; Drug
Intervention description(s): Placebo; PF-06372865
Intervention MeSH terms: PF-06372865
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: PF-06372865; Safety; Tolerability; Pharmacokinetics; Multiple dose; Healthy subjects
Norms Expansion and Validation for IntelliSpace Cognition
Condition: Cognitive Functioning of Healthy Individuals
Study type: Interventional

Summary: 
      This study aims to expand the normative dataset for Philips IntelliSpace Cognition to include
      ages 18-49 and 80+ and aims to validate two new digital tests.
    


Intervention name(s): Philips IntelliSpace Cognition (ISC).; Paper-Pencil Tests.
Intervention type(s): Device; Diagnostic Test
Intervention description(s): Philips ISC is a Class-II Medical Device in the US that aids in assessing cognition and helps inform the HealthCare Professional (HCP) to make a diagnosis and treatment plan. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.; The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cognitive model; Cognitive assessment; Digital cognitive tests; Automated scoring; Algorithms
Comparison Between Conventional and Model-based Infusion Strategy of IV PCA in Patients Undergoing RALP
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Comparing postoperative analgesics requirements and complications between conventional and
      model-based infusion strategy of intravenous patient-controlled analgesia in patients who
      undergoing robot assisted laparoscopic radical prostatectomy

      Group A: conventional intravenous patient-controlled analgesia, Group B: model-based infusion
      strategy of intravenous patient-controlled analgesia
    

Detailed description: 
      The investigators compared postoperative analgesics requirements and complications between
      conventional and model-based infusion strategy of intravenous patient-controlled analgesia
      (IV PCA) in patients who undergoing robot assisted laparoscopic radical prostatectomy (RALP)

      Group A: conventional IV PCA, Group B: model based IV PCA

        1. Primary endpoint: comparison of postoperative analgesic requirements in patient
           undergoing robot assisted laparoscopic radical prostatectomy (RALP) between conventional
           patient controlled analgesia (PCA) (Group A) and effective-compartment based dosing
           strategy of PCA (Group B)

        2. Secondary endpoint: 1) VAS analysis between two groups, 2) postoperative nausea and
           vomiting analysis between two groups, 3) complication evaluation between two groups
    

Intervention name(s): fentanyl
Intervention type(s): Drug
Intervention description(s): fentanyl with antiemetic drug
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Intestinal Microbiota and Chronic Fatigue Syndrome
Condition: Fatigue Syndrome, Chronic; Microbial Colonization
MeSH terms: Communicable Diseases; Infections; Fatigue Syndrome, Chronic; Syndrome; Fatigue
Study type: Interventional

Summary: 
      Gut microbiota of 1) patients with chronic fatigue syndrome and 2) their healthy family
      members are analyzed.

      Up to 40 patients with chronic fatigue syndrome are randomized to receive either 1) a faecal
      transplant from a healthty donor or 2) their own feces via colonoscopy. Patient's health
      related quality and ability to work are assessed (baseline, 1 and 6 months after the
      procedure)
    

Detailed description: 
      Patients with chronic fatigue syndrome (CFS) and their healthy family members (living
      together in the same house) are recruited in the study. CFS has been diagnosed in Tampere
      University Hospital and the diagnosis is based on thorough clinical assessment fulfilling the
      Institute of Medicine 2015 criteria. Patients microbiota is analyzed (microbiological
      analysis, mediators of inflammation) and results are compared with their family members.

      Via colonoscopy, up to 40 patients with CFS are randomized to receive either a faecal
      transplant from a healthy donor (treatment group) or his/her own feces (placebo group).
      Products are blinded, investigators and patients are blinded. Patients' health related
      quality of life and ability to work or study are assessed (baseline, 1 and 6 months after the
      procedure).
    

Intervention name(s): Faecal transplantation; Placebo faecal transplantation
Intervention type(s): Procedure; Procedure
Intervention description(s): Faecal transplantation from a healthy donor via colonoscopy; Placebo faecal transplantation containing patient's own feces via colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blinded study, treatment group and placebo-group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fatigue; microbiome
Trans-incisional Quadratus Lumborum Block Versus Caudal Analgesia in Pediatric Open Renal Surgeries.
Condition: Anesthesia
Study type: Interventional

Summary: 
      There is scare literature about the usage of QLB in pediatric population, particularly the
      trans-incisional approach. Hence, the purpose of this study is to compare the postoperative
      analgesic efficacy of ultrasound-guided caudal epidural block versus ultrasound-guided QLB
      (trans-incisional) in combination with general anesthesia in pediatric patients undergoing
      elective open renal surgeries regarding pain scores, total analgesic consumption, and adverse
      effects.
    


Intervention name(s): Trans-incisional Quadratus lumborum block; Caudal block
Intervention type(s): Procedure; Procedure
Intervention description(s): patients will receive combined general anesthesia and quadratus lumborum block (trans-incisional) with 0.5 mL/kg of bupivacaine 0.2 %. with maximum volume was limited to 20 ml; patients will receive combined general anesthesia and caudal analgesia (just after wound closure) with 1.25 mL/kg of bupivacaine 0.2 % (three parts 0.25 % bupivacaine to one part saline.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment