bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Screening and Cognitive Training in Seniors
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study will provide cognitive screenings for seniors age 50 and older. It will also
      investigate the benefits of two different cognitive training programs for seniors who have
      lower baseline performance on memory and/or gist reasoning tests.
    

Detailed description: 
      This study consists of two parts which includes cognitive screening and cognitive training.
      Participants will initially participate in the cognitive screening portion of the study. If
      qualified, participants will participate in the cognitive training portion of this study
      which includes additional cognitive communication, neuropsychological testing, and EEG.
    

Intervention name(s): Strategic Memory Advanced Reasoning Training; Brain Health Workshop
Intervention type(s): Behavioral; Behavioral
Intervention description(s): SMART teaches strategies to improve the ability to process information.; Brain Health Workshop provides information about brain health in a seminar format. Topics include: sleep, nutrition, and exercise.
Other intervention name(s): SMART
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rescuing the Microbiome Effectively With Different Doses of B. Infantis in Infants
Condition: Gut Microbiome
Study type: Interventional

Summary: 
      The REMEDI Study is a single-center, prospective, double-blind, randomized,
      placebo-controlled trial of multiple doses of B. infantis EVC001 supplementation in healthy
      term breastfed infants.
    

Detailed description: 
      Mother-infant dyads will be enrolled when the infant is 2-4 months of age. A 1-week lead-in
      period will be utilized to collect baseline microbiome samples and for the completion of
      daily and weekly feeding and health logs. Subjects that meet eligibility criteria on Day 7
      will be randomized into 1 of 4 treatment arms. Supplementation will begin on Day 8 and will
      continue for a total of 28 consecutive days. Subjects will be followed for an additional 4
      weeks after the cessation of the supplement. The total duration of the study will be
      approximately 9 weeks. Infant stool and urine samples, as well as maternal breast milk
      samples, will be collected on multiple occasions during the study. Mothers will be asked to
      complete questionnaires and health logs during the course of the study as well.
    

Intervention name(s): B. infantis EVC001; Lactose
Intervention type(s): Other; Other
Intervention description(s): A once-daily oral feeding of B. infantis EVC001 will be mixed with breast milk and provided to infants for 28 consecutive days.; A once-daily oral feeding of a lactose placebo will be mixed with breast milk and provided to infants for 28 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be enrolled and randomized 1:1:1:1 to the following treatment arms (daily dose of B. infantis EVC001): high dose, medium dose, low dose, and placebo.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain
Condition: Chronic Low-back Pain; Hip Impairments; Hip-spine Syndrome; Osteoarthritis
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Older adults with chronic low back pain (LBP) are at a greater risk for disability, loss of
      independence, and lower quality of life. Experts agree that LBP is not a homogeneous
      condition, and treatments should differ based upon clinical presentation. One particular
      subgroup of older adults with chronic LBP are those that also have hip pain and muscle
      weakness; in addition, many of these individuals have limited and painful movement of the
      lumbar spine. Our past work indicates that all of these hip and lumbar spine impairments may
      contribute to worse physical function and greater disability, but the relative importance of
      each impairment is unclear. Thus, clinicians have limited evidence to draw on for treatment
      decisions, for this patient population. This randomized clinical trial is designed to explore
      two different interventions: one that addresses these hip issues (hip-focused) and one that
      focuses more directly on the lumbar spine (spine-focused). We aim to recruit a sample of 180
      older adults who have chronic LBP, as well as hip impairments (i.e. pain and muscle
      weakness). To ensure our findings are generalizable, the study will be conducted across three
      sites in different geographical regions: University of Delaware, University of Pittsburgh,
      and Duke University.
    


Intervention name(s): Hip-focused rehabilitation intervention; Spine-focused rehabilitation intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.; The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: older adult; geriatrics; chronic low back pain; low back pain; hip-spine; rehabilitation; physical therapy; spine; hip pain
FREE Living Hulled HEMP Seed and Oil Trial
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The objectives of this trial are to assess the effects of hemp product consumption,
      specifically hulled hemp seeds and hemp oil on blood fatty acid profiles and cardiovascular
      disease risk factors, in healthy overweight volunteers after 4 weeks of consumption.
    

Detailed description: 
      The trial will be a 4 week double-blinded, randomized, cross-over design with 2 treatment
      intervention (hemp and control) periods separated by a 4 week washout period. Thirty
      metabolically healthy overweight volunteers will be recruited into the trial.

      On day 1, and 27, 28 of each treatment period participants will be asked to come to the
      Richardson Center for Functional Foods and Nutraceuticals (RCFFN) for a 12 hour fasted blood
      sample. On day 1, participants will be given prepackaged sachets of treatment hulled seeds
      (hemp or sesame) and salad dressing, containing 30 g/d of treatment (hemp or soybean) oil (in
      individually packaged daily containers) will also be supplied.

      Participants will be instructed by clinical coordinators to integrate the products (2 sachets
      of seeds, 1 salad dressing) into their daily meals and to avoid other dietary sources of n-3
      fatty acids, such as flax, chia, camelina, krill and fish products. Participants will be
      given activity monitors to wear during the intervention periods. Participants will be
      required to eat one sachet of hulled seeds in the morning and one in the evening, and to
      consume the dressing throughout the day, for each 4 week treatment period.

      Participants will be asked to continue their habitual diets, while avoiding large dietary
      sources of n-3 fatty acids, throughout the treatment and washout periods. Participants will
      be instructed to maintain the same level of physical activity and alcohol intake throughout
      the trial period. The trial coordinator will contact participants weekly via telephone or
      email to monitor treatment adherence and to answer any questions or concerns participants
      might have. Background dietary intakes will be measured at day 1 of the trial using a food
      frequency questionnaire, and during each treatment period by 3-day food record to be
      completed in the last week of each treatment period. Participants will be asked questions
      about the interventions including side effects, mood and perceived energy level by trial
      coordinators at the end of each intervention period.
    

Intervention name(s): Control; Hemp foods
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: hemp oil,; hemp; fatty acids; omega-6; omega-3; blood pressure; blood lipids
Is the Exhaled Nitric Oxide in Infants a Predictive Marker of Asthma ?
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Background:

      It seems that in the infants and the young children, the increase of the Exhaled Nitric Oxide
      (eNO) is in connection with: (1) the risk of developing respiratory symptoms; (2) the risk of
      family and personal atopy; (3) the intensity of the respiratory symptoms; (4) the risk of
      passage of recurrent wheezing to asthma; (5) and contrary to the fact that the investigators
      noticed at the child's a positive relation with the environmental tobacco smoke

      Objective: the investigators objective is to bring to light that the rise of the eNO, a non
      invasive biomarker of the bronchial inflammation, would be a risk factor expected from
      passage of recurrent wheezing of the infant and the young child (of less than 36 months old)
      towards the asthma of the child.Methods: Once the diagnosis of recurrent wheezing
      established, the investigators estimate by questionnaire the severity of the asthma, the
      personal and familial atopy, the collection of the environmental data. After allergic
      exploration (skin tests and assay of serum total and specific IgE, complete blood count), the
      eNO is measured by an off-line tidal breathing method using a chemiluminescence NO analyzer.
      Annually, a questionnaire will be send to families to appreciate the persistence or the
      remission of the asthma. After a simple descriptive analysis of the population and a
      multifactorial descriptive analysis, the investigators shall look for the connections between
      the rise of the eNO and the various clinical, biological and environmental parameters known
      to influence the variations of this marker. Then the investigators shall select a set of
      explanatory variables for a multivariate analysis by a logistic regression step by step.
    

Detailed description: 
      This study is a epidemiological observation study
    

Intervention name(s): Measure of the exhaled NO
Intervention type(s): Other
Intervention description(s): The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Infants; Exhaled Nitric Oxide; Asthma; Tobacco smoke exposure; environment
EEG@HOME (Phase 2 of the Project, Measurements in Healthy Volunteers)
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional

Summary: 
      The goal of this project is the development of an EEG-cap (min. 21 electrodes) with
      user-friendly active dry electrodes that meets the expectations of the users regarding
      comfort and esthetics, without losing sight of the functional and technical demands for
      recording high quality EEG signals. The purpose is to use the EEG-cap to investigate clinical
      neurological disorders (e.g. epilepsy). The EEG-cap could also be used at home so that
      hospital admission in the EMU can be avoided for some patients and an increasing number of
      patients can be examined.

      In Phase 2 of the project will comprise of an EEG-registration with the different types of
      electrodes in healthy volunteers. For each volunteer the EEG-recording with dry electrodes
      will be compared to the EEG-recordings with conventionally used wet electrodes (bridge and
      cup electrodes). In addition each volunteer will undergo a somato-sensory evoked potential
      (SSEP) measurement with different types of electrodes. Analogously to the EEG-registrations,
      for each volunteer the SSEP measurement with the dry electrodes will be compared to the SSEP
      measurement with conventionally used wet electrodes (bridge and cup electrodes). Each
      EEG-registration will take between 5 and 10 minutes.

      Minimum 2 - maximum 10 healthy volunteers will be included.

      There will be an visual and clinical evaluation of the EEG-signals (blinded) and a technical
      evaluation of the EEG-signals. User experience will also be collected.
    


Intervention name(s): EEG
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
LINX Reflux Management System Clinical Study Protocol
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety and effectiveness of the LINX Reflux
      Management System in the treatment of Gastroesophageal Reflux Disease (GERD).
    

Detailed description: 
      At present, the primary alternative for GERD patients with an incomplete symptomatic response
      to proton-pump inhibitors (PPIs) is laparoscopic Nissen fundoplication. This surgical
      procedure continues to be the prevalent non-medical treatment option for GERD patients,
      despite several important limitations. First, it is a very traumatic procedure, requiring
      portions of the stomach to be dissected and then wrapped around the tubular esophagus,
      creating permanent anatomic alterations. Secondly, it can create significant side effects,
      such as gas bloat syndrome, the inability to belch and the inability to vomit.

      The intent of the LINX System is to allow a surgeon, using existing laparoscopic techniques
      and instruments, to augment a weak LES and restore the defective barrier at the
      gastroesophageal junction (GEJ). This defect of the GEJ is the source of abnormal reflux. The
      LINX device is an expandable string of individual titanium beads with magnetic cores. The
      device is laparoscopically placed as a ring around the lower esophageal sphincter. The
      magnetic attraction of the beads augments the esophageal sphincter's ability to resist
      gastric pressures that cause reflux. At rest, the LINX device encircles the sphincter with
      each bead resting against an adjacent bead, to avoid compression of the tubular esophagus.
      When swallowing, higher pressures are created, allowing the magnetic bond between beads to
      break, and the LINX implant to expand radially. This serves to preserve swallow and other
      physiologic functions, such as belching and vomiting, and avoids the side effect of
      post-prandial bloating. The device can be placed with minimal dissection, preserving anatomy,
      and is also removable, if necessary. This provides important benefits as it preserves the
      native anatomy, unlike the Nissen procedure.
    

Intervention name(s): Magnetic Sphincter Augmentation
Intervention type(s): Device
Intervention description(s): The area of the lower esophageal sphincter (LES) is accessed using a standard laparoscopic approach. The tubular esophagus, in the area of the LES, is sized and the appropriately sized sphincter augmentation device is placed circumferentially around the esophagus in the area of the LES. After confirming proper placement, the ends of the device are secured. At this point, the implant procedure is complete, laparoscopic instruments are withdrawn and access points are closed.
Other intervention name(s): LINX Reflux Management System; Magnetic Esophageal Sphincter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux
Feasibility and Impact of a Tele-rehabilitation Program in Patients With Chronic and Non-specific Neck Pain
Condition: Chronic Non-specific Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Chronic neck pain has a high prevalence in developed countries, being one of the main causes
      of years lived with disability and deterioration of the quality of life. Telerehabilitation
      is presented as a resource capable of favoring, with its development and implementation, the
      transition to a universal and quality health service. The main objective of the study is to
      assess the change in disability produced by a telerehabilitation program (applied in the
      intervention group) in patients with chronic and nonspecific neck pain compared to the
      recommendation of home exercises (control group).

      The study that will be carried out will be a controlled and randomized clinical trial (ECCA),
      single-blind, longitudinal and prospective with two groups (intervention group and control
      group). The main study variables that are intended to be analyzed pre and post intervention
      are disability, quality of life, pain, adherence, and depression and anxiety.

      The study will take place between June 2020 and May 2021 in specialized physiotherapy
      clinics.
    


Intervention name(s): MANUAL THERAPY; THERAPEUTIC EXERCISE
Intervention type(s): Other; Other
Intervention description(s): The investigators will apply manual therapy for ten minutes a week, for 8 weeks, based on cervical mobilizations and suboccipital inhibitions.; The exercises recommendations will be based on a simulation of the exercises in the same session of the manual therapy of each week, helped by the physiotherapist.
The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study of Neoadjuvant Bio-C/T Followed by Concurrent Bio-R/T in High-risk Locally Advanced Oral Squamous Cell Carcinoma
Condition: Oral Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      Surgical resection followed by concurrent chemoradiotherapy is considered as the standard of
      care for locally advanced OSCC (LAOSCC). Although the treatment could provide prompt local
      control, but it is also associated with high incidence of distant failure. Systemic
      chemotherapy given either before (neoadjuvant) or after (adjuvant) definitive local treatment
      has been extensively evaluated to improve the clinical outcome in LAOSCC. Regimens of
      taxane/cisplatin-based combinations have been shown to improve the treatment outcome of
      patients with locally advanced head and neck squamous cell carcinoma (HNSCC) in neoadjuvant
      setting. Recently, cetuximab (Erbitux®), a monoclonal antibody against epidermal growth
      factor receptor (EGFR), has also been proven to be an efficient agent for advanced and/or
      refractory HNSCC with acceptable toxicity profiles. In current study, we shall evaluate the
      feasibility, efficacy and safety of a triplet bio-chemotherapy consisting of cetuximab,
      paclitaxel, and cisplatin followed by cetuximab-based concurrent bio-radiotherapy (CBRT) in
      patients with LAOSCC.
    

Detailed description: 
      Patients with high-risk, locally advanced (TxN2b~3 or T4N0~3, M0) OSCC will be eligible. To
      detect an interested objective response rate (p1) of 80% versus a non-interested response
      (p0) rate of 60%, with an α and 1-β of 0.05 and 0.2, respectively (two-sided test), including
      the estimated dropout rate of 10%, a total of 47 patients will be recruited.
    

Intervention name(s): Cetuximab,Paclitaxel,Cisplatin
Intervention type(s): Drug
Intervention description(s): Cetuximab 500 mg/m2 iv infusion (120 min for the 1st infusion, 90 min for the 2nd , and 60 min for the subsequent) Paclitaxel 120 mg/m2 3-hour iv infusion Cisplatin 50 mg/m2 2-hour iv infusion
Intervention MeSH terms: Paclitaxel; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: oral squamous cell carcinoma; neoadjuvant bio-chemotherapy; concurrent bio-radiotherapy; biomarker
A Study To Describe The Effect Of Impaired Hepatic Function Of The Pharmacokinetics Of Palbociclib
Condition: Healthy, Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study to describe the plasma pharmacokinetics of a single oral 75mg dose of
      palbociclib administered to healthy volunteers, and subjects with mild, moderate, and
      severely impaired hepatic function.
    

Detailed description: 
      This is a 4-cohort single period study. The four cohorts will consist of healthy volunteers,
      and subjects with mild, moderate, and severely impaired hepatic function. Each cohort will
      receive the same treatment consisting of a single oral 75mg dose of palbociclib administered
      with food. Serial PK samples will be drawn up to 120 hours post dose for the cohort
      consisting of healthy volunteers, and will continue until up to 192 hours post-dose for the
      cohorts of hepatic impairment subjects.
    

Intervention name(s): Palbociclib 75 mg Capsule
Intervention type(s): Drug
Intervention description(s): Single oral 75 mg dose of palbociclib followed by serial PK sampling up to 192 hours post-dose (up to 120 hours post-dose for the healthy volunteer cohort).
Other intervention name(s): Palbociclib, PD-0332991
Intervention MeSH terms: Palbociclib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Palbociclib, PD-0332991, Hepatic Impairment
Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness
Condition: Hidradenitis Suppurativa (HS)
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Observational

Summary: 
      This study assesses Humira's® real-life effectiveness in the management of dermatological
      manifestations of moderate to severe Hidradenitis Suppurativa (HS).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with moderate or severe HS
      
Keywords: Hidradenitis Suppurativa (HS); Humira®; Canada
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR
Condition: Hygiene
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the safety of the gynecological formulation in
      normal and usual usage condition of Dermacyd Delicata Pocket.
    


Intervention name(s): Lactic acid (Dermacid)
Intervention type(s): Drug
Intervention description(s): Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care