bioihbjkbjnl/mcl2 huggingface dataset:
ParKinWalk: Physical Activity and Long Group-walking for Parkinson's Disease
Condition: Parkinson Disease; Healthy Aging
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The study will evaluate the impact of exercise training program followed by long-walking onon
      supervised and unsupervised gait assessment in Parkinson´s disease and control subjects.
    

Detailed description: 
      Background: Several studies suggest an impact of physical exercise on walking parameters in
      Parkinson´s disease (PD) patients.

      Objective: the present study will evaluate the impact of three months physical exercise
      training program followed by a group-long walking on motor impairment in PD.

      Methods:

      PD patients will be randomized in two arms: one group will be assessed to a training exercise
      program of three months followed by long-walking in group under the support of
      physician/physiotherapist and caregivers. A complete motor, cognitive and general assessment
      will be performed at baseline. The patients will be evaluated under supervised an
      unsupervised conditions at baseline, before the long-walking, during the walking and after 2
      months after the walk.
    

Intervention name(s): Exercise program followed by long walk in group; Exercise program followed by long walk in group (controls)
Intervention type(s): Other; Other
Intervention description(s): The subjects will be included in a training exercise program for three months followed by a long-walk in group; The controls matched for age will perform the same exercise program and long walk as the PD subjects
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A group of Parkinson´s disease Patientserform physical acitivy training for three months followed by long-walking while a parallel group of PD patients will not be included in the training.
A group of age-matched controls will be included in the training protocol as well. matched with
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
FOLFOXIRI Plus Panitumumab In Kras and Braf Wild-Type Metastatic Colorectal Cancer
Condition: Metastatic Colo-rectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The GONO-FOLFOXIRI regimen demonstrated higher activity and efficacy compared to FOLFIRI in a
      phase III trial. Panitumumab with oxaliplatin- or irinotecan-based doublets is feasible and
      associated with improved activity in KRAS codon 12-13 wild-type patients. BRAF and other RAS
      rare mutations have been suggested as additional potential biomarkers for anti-EGFR agents in
      metastatic colo-rectal cancer. The present study aims to demonstrate the feasibility and the
      activity of the first-line combination of the GONO-FOLFOXIRI regimen and Panitumumab in
      molecularly selected metastatic colo-rectal cancer patients.
    


Intervention name(s): FOLFOXIRI + Panitumumab
Intervention type(s): Drug
Intervention description(s): PANITUMUMAB 6 mg/Kg i.v. over 1 hour followed by IRINOTECAN 150 mg/sqm i.v. over 1 hour followed by OXALIPLATIN 85 mg/sqm i.v. over 2 hours concomitantly with L-LV 200 mg/sqm over 2 hours followed by 5-FLUOROURACIL* 2400 mg/sqm c.i. over 48 hours starting on day 1 repeated every 2 weeks.
Intervention MeSH terms: Panitumumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RAS Wild-Type; BRAF Wild-Type
Th17 Inducing Cytokines Pregnancy and After Postpartum
Condition: Pregnancy
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to investigate salivary and gingival crevicular fluid (GCF) levels
      of IL-17A, IL-17E, IL-6 AND IL-23 during 2/3 trimester of pregnancy and after delivery.
    

Detailed description: 
      IL-17 have a synergytic effect with IL-6 and IL-23. IL-17A levels elevated with periodontal
      diseases. Many systemical chronic conditions such as atherosclerosis and cardiovascular
      disease, pregnancy may contribute increasing of IL-17 family cytokine.
    

Intervention name(s): Saliva collection; GCF collection
Intervention type(s): Other; Other
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All participants had 20 teeth present at least.
      
Keywords: periodontitis; postpartum
Parameter Changes in Functional Electrical Stimulation
Condition: Gait Disorders, Neurologic
MeSH terms: Nervous System Diseases; Gait Disorders, Neurologic
Study type: Observational

Summary: 
      This study aims to look at how changes to a person's functional electrical stimulation might
      change how they walk. Functional electrical stimulation (FES) is commonly used to help people
      with foot drop from upper motor neurone conditions such as stroke or multiple sclerosis. This
      group of people have muscle weakness which makes it difficult to lift the foot, which causes
      trips and falls.

      FES reduces foot drop by using a portable device to apply short electrical pulses to the
      nerve which lifts the foot. The FES device stimulates this nerve only during the swing phase,
      when the foot is off the floor. Typically this is achieved by using a foot-switch, which
      detects when the heel leaves the floor. Stimulation begins a short interval of time after the
      heel leaves the floor, ramps up from zero to set stimulation for the individual, and at
      another period of time after the heel hits the floor, stimulation ramps down from set amount
      to zero. There are four time intervals described here which can be varied by the clinician on
      the device:-

        -  Delay (the time between heel lift and the start of stimulation)

        -  Ramp up (the time for stimulation to reach full strength)

        -  Extension (the time between heel strike and the ramp down)

        -  Ramp down (the time for stimulation to reach zero from full strength) These intervals
           are usually set by experienced clinicians using a qualitative assessment of the
           patient's walking and trial-and-error. A literature review has found no published
           studies which compare walking with different timing. This knowledge would be useful for
           clinicians, who could use this information as a starting point in finding the best
           timing parameters for each patient.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population for this study is adult users of standard FES for foot drop, registered with
        the Leeds FES service. Any upper motor neurone lesion can be the primary condition.
A Study to Evaluate the Efficacy and Safety of Dasotraline in Children 6 to 12 Years Old With Attention-Deficit Hyperactivity Disorder (ADHD) in a Simulated Classroom Setting.
Condition: Attention-Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the efficacy and safety of dasotraline in children 6 to 12 years of age
      with Attention-Deficit Hyperactivity Disorder (ADHD) in a simulated classroom setting.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety
      study in children with ADHD in a laboratory classroom setting. The study will be comprised of
      3 periods: Screening (up to 35 days) including a 3 - 5 day ADHD medication washout prior to
      Day -1; Double-blind randomized treatment with either dasotraline (2 mg/day) or placebo for
      14 days; and a final safety evaluation 7 days after last dose. Prior to the start of
      treatment (Day 1) and following the conclusion of the double-blind period (Day 15), subjects
      will undergo a full-day laboratory classroom evaluation in cohorts of up to 18 subjects. Each
      laboratory classroom day will include seven 30-minute simulated classroom sessions where
      trained observers will assess subjects using the Swanson, Kotkin, Agler, M-Flynn, and Pelham
      (SKAMP) Scale. In addition during each classroom session, a 10-minute math test (Permanent
      Product Measure of Performance [PERMP]) will be administered to evaluate sustained attention
      and effort. Seven (± 2) days after the last dose of study drug, subjects will return to the
      clinic and complete safety assessments.

      This study is designed to test the superiority of dasotraline 2 mg/day against placebo based
      on Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP)-Combined score in pediatric
      subjects aged 6-12 years with ADHD who weigh ≤ 30 kg
    

Intervention name(s): dasotraline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): dasotraline 2mg capsule once daily; Placebo capsule once daily
Other intervention name(s): SEP-225289
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study in children with ADHD in a laboratory classroom setting
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention-Deficit Hyperactivity Disorder (ADHD)
Pharmacokinetics and Pharmacodynamics of RPH-104 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first in human study is to evaluate the safety and tolerability of
      RPH-104 in humans.
    

Detailed description: 
      RPH-104 is a macromolecular compound with a molecular weight of 152.715 kilodalton (Data on
      file) and is capable of binding human interleukin-1 beta (IL-1β). It has also been shown in
      vitro to be a highly potent inhibitor of IL-1β signalling pathway, with low picomolar
      inhibitor activity. In this First in Human study, RPH-104 will be evaluated primarily for its
      safety and tolerability. In a phase I study conducted with health volunteers, a similar
      monoclonal antibody, canakinumab, was investigated in terms of pharmacokinetics and
      pharmacodynamics besides efficacy and safety. Similarly, this aimed to investigate effects of
      RPH-104 on selected pharmacodynamic parameters, including Anti-Drug Antibodies (ADA) along
      with obtaining first human data on pharmacokinetics of RPH-104 in humans will be investigated
      in the same study.
    

Intervention name(s): RPH-104; Sodium chloride Sterile Injection 0.9% w/v
Intervention type(s): Biological; Other
Intervention description(s): Anti-IL-1 Mab; Sterile saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: safety; tolerability; RPH-104; RPH104; Anti-IL1 beta; Anti-IL1
Oral Peanut Immunotherapy
Condition: Peanut Allergy
MeSH terms: Peanut Hypersensitivity
Study type: Interventional

Summary: 
      Peanut allergy is one of the most serious food allergies because of its life long
      persistence, and the potential for severe allergic reactions. Effective oral immunotherapy
      would benefit patients by reducing the likelihood that they will have life-threatening
      accidental allergic reactions. This research study is being done to develop an effective oral
      immunotherapy treatment for patients with peanut allergy.
    

Detailed description: 
      Our hypothesis is that chronic antigen exposure during peanut oral immunotherapy (OIT) will
      induce beneficial changes in the specific immune response, including: 1) anergy of IgE
      effector immune cells (e.g., mast cells, basophils) resulting in clinical desensitization; 2)
      induction of de novo, long lived (memory) B cell responses that antagonize specific IgE and
      confer immune tolerance. The investigators will test this hypothesis in the following
      specific aims:

        1. Induce desensitization in peanut allergic subjects with peanut OIT and evaluate the
           safety of the peanut OIT desensitization protocol.

        2. Induce long-standing tolerance in peanut allergic subjects with maintenance peanut OIT
           and evaluate the efficacy of allergen-specific testing to predict tolerance.

        3. Longitudinally evaluate basophil and mast cell reactivity in subjects receiving peanut
           OIT and their relationship to the induction of desensitization.

        4. Longitudinally evaluate the allergen-specific B-cell repertoire in subjects receiving
           peanut OIT and its relationship to the induction of tolerance.
    

Intervention name(s): Peanut flour OIT
Intervention type(s): Drug
Intervention description(s): Patients will receive daily escalating dosages (Peanut flour OIT) as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The observational control arm (parallel for the first year) was then offered to cross over to active treatment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peanut Allergy; Peanut Hypersensitivity
Effects of Hip Distraction Without a Perineal Post on Venous Blood Flow and Peripheral Nerve Conduction
Condition: Hip Disease
Study type: Observational [Patient Registry]

Summary: 
      The purpose of this pilot study is to evaluate the effects of hip distraction without a
      perineal post on the lower extremity during hip arthroscopic procedures by peri-operative
      monitoring of various prognostic markers for venous, nerve and tissue injury.
    

Detailed description: 
      The purpose of this pilot study is to evaluate the effects of hip distraction without a
      perineal post on the lower extremity during hip arthroscopic procedures by peri-operative
      monitoring of various prognostic markers for venous, nerve and tissue injury. The data from
      this exploratory study can be used to help develop estimates of the proportions of patients
      who experience significant venous/nerve/tissue compromise in the lower extremity as a result
      of the application of traction forces necessary to achieve hip joint distraction, and may
      serve as a basis for sample size planning in future studies comparing the effects of various
      methods of hip distraction techniques during hip arthroscopy.
    

Intervention name(s): Hip Arthroscopy Procedure
Intervention type(s): Procedure
Intervention description(s): The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population description is to include male or female subjects between the ages of 18
        and 65 years, inclusively, with an election to undergo a standard hip arthroscopic
        procedure that is expected to require access to the central compartment of the hip joint
        (bilateral hip enrollment is allowed).
Dose Escalation, Safety and Pharmacokinetic Study of AVE8062 in Patients With Solid Tumors
Condition: Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective: To determine the maximum tolerated dose based on the incidence of dose
      limiting toxicity and the maximum administered dose of AVE8062 administered every 3 weeks in
      patients with advanced solid tumors.

      Secondary objectives:

        -  To assess the overall safety profile of the drug.

        -  To characterize the pharmacokinetic profile of AVE8062 and its active metabolite RPR
           258063.

        -  To evaluate anti-tumor activity of the drug.
    

Detailed description: 
      The duration of the study for each patient will include an up to 4-week screening phase,
      21-day study treatment cycles, an end of treatment visit and a follow-up period.
    

Intervention name(s): ombrabulin (AVE8062)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: injection solution
Route of administration: intravenous infusion
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Wood Smoke Particles on Influenza-induced Nasal Inflammation in Normal Volunteers
Condition: Response of Viral Infection to Woodsmoke
MeSH terms: Virus Diseases; Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is focused on the pathophysiology underlying the association between exposure to
      particulate pollutants and risk for/response to viral infection. The investigators
      hypothesize that exposure to wood smoke particles (WSP) enhances influenza virus-induced
      granulocyte and NK cell activation, via hyaluronic acid-mediated effects on IFNg production.
      Oxidant stress and viral replication may also be affected. As an NIH funded ViCTER project,
      the purpose of the study is also to test novel assays of granulocyte activation (Doershuk
      lab) and lipid mediator activation (Albritton lab) which have not previously been used in
      this type of research.

      Healthy, nonsmoking adults age 18-40 years will be recruited. This is a randomized, placebo
      controlled study comparing NLF granulocyte responses to LAIV administered after either WSP or
      clean air, in normal healthy volunteers. Subjects receive either WSP or placebo (clean air),
      followed by a standardized dose of LAIV and serial post-infection sampling of nasal lavage
      fluids, nasal biopsy and blood
    


Intervention name(s): wood smoke; clean air
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: LAIV; Flumist; wood smoke
Comparison of Postoperative Pain After Gallbladder Retrieval From Umbilical and Epigastric Ports.
Condition: Cholelithiasis
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones; Pain, Postoperative
Study type: Interventional

Summary: 
      To know the association of postoperative pain after gallbladder removal from umbilical port
      site versus epigastric portsite, after four ports laparoscopic cholecystectomy,and the
      epigastric port site was found to be friendly for the patients in terms of less pain after
      gallbladder removal from this site after surgery.
    

Detailed description: 
      Objective: To know the association of postoperative pain after gallbladder removal from
      umbilical port site versus epigastric port site, after four ports laparoscopic
      cholecystectomy.

      Randomized controlled trial was performed during 1-year period from January 2017 till January
      2018, at a private hospital setup. Both male and female patients, with age group 18 and
      above, in years, were considered, who were planned four ports laparoscopic cholecystectomy
      after typical cholelithiasis. Those patients with polyps , mucocele or empyema in gallbladder
      or perforated gallbladder requiring emergency surgery were omitted from the study. The
      patients were randomly selected, 65 in which gallbladder was removed from umbilical region
      (group A) and 65 from epigastric region (group B) respectively. Determination of
      postoperative pain was done on day one, at the time of release from the hospital and at
      follow-up time one-month post-surgery, with the help of Numerical Analogue Scale (NAS).
    

Intervention name(s): Laparoscopic cholecystectomy
Intervention type(s): Procedure
Intervention description(s): Four ports laparoscopic cholecystectomy under general anaesthesia
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Evaluation of the Eversense Continuous Glucose Monitoring System in Type I Diabetic Youth
Condition: Self Care
Study type: Interventional

Summary: 
      The purpose of this clinical investigation is to provide pilot clinical data to direct
      pivotal study development for the pediatric indication of the Senseonics Continuous Glucose
      Monitoring System (CGM) measurements when compared with finger stick blood glucose monitoring
      in an outpatient setting. (The investigation will also evaluate safety of the Senseonics CGM
      System usage, get feedback regarding subject and caregiver acceptability of the device and
      the mobile medical application (MMA).
    

Detailed description: 
      This is a non-randomized, non-blinded, prospective, single-arm, single-center pilot study,
      enrolling up to 15 pediatric subjects in two cohorts (5 subjects age 6-12 and 10 subjects age
      13-17) with diabetes mellitus for up to 180 days. Study will evaluate the system at home with
      comparison to SMBG with clinic check visits and downloading of stored data every 30 days.
      Subjects will have one Sensor inserted subcutaneous by trained Investigators. The System will
      be set to provide real-time glucose information, including alarms and alerts in the home
      settings. The system is for adjunctive use. All diabetes care decisions will be based on SMBG
      values rather than System CGM results.
    

Intervention name(s): Eversense Continuous Glucose Monitoring
Intervention type(s): Device
Intervention description(s): The Eversense Continuous Glucose Monitoring System is a glucose monitoring device intended to continually measure interstitial fluid glucose levels in individuals with diabetes for the operating life of the sensor.The System comprises a sensor and a transmitter. The small sensor will be subcutaneously inserted in the arm.The transmitter reads glucose data from the subcutaneous sensor.
Other intervention name(s): Senseonics Continuous Glucose Monitoring System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; pediatrics; blood sugar devices
Back Pain Response to Different Acupuncture Methods
Condition: Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Acupuncture has been used for many years to help relieve pain. However, it is not clear how
      acupuncture works. We are doing this study to learn about the effects of different forms of
      acupuncture on chronic low back pain. We are interested in learning about brain activity
      during pain. We plan to look at brain activity at the beginning and the end of the study,
      after 6 sessions of acupuncture.
    


Intervention name(s): Traditional Acupuncture; Laser Acupuncture
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Lower Back Pain; Acupuncture