bioihbjkbjnl/mcl2 huggingface dataset:
Study of Patient Navigation to Reduce Social Inequalities
Condition: Colorectal Cancer Screening
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      Variations in participation to the colorectal cancer screening seems to reveal social and
      geographical inequalities. Our study will investigate whether patient navigation could
      increase the participation to the colorectal cancer screening and in the same time, reduce
      the social inequalities.
    


Intervention name(s): Patient Navigation
Intervention type(s): Other
Intervention description(s): Insured people receive firstly a letter to inform them that a patient navigator is available to navigate them during the colorectal screening steps. A free telephone number and the navigator schedule is given. After a minimum of one week the patient navigator begins the telephone outreach.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Screening
Keywords: Colorectal cancer screening; Social inequalities; Patient Navigator
Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental Implant in Posterior Maxilla
Condition: Missing Teeth
MeSH terms: Tooth Loss; Anodontia
Study type: Interventional

Summary: 
      Effect of Topical Application of Hyaluronic Acid on Stability of Immediate Loading Dental
      Implant in Posterior Maxilla
    

Detailed description: 
      Patients were randomly divided into two groups:

      Group I (Control group):

      Ten implants were placed in posterior maxilla and immediately loaded.

      Group II (Study group):

      Ten implants were coated with HA before placement in posterior maxilla and immediately
      loaded.
    

Intervention name(s): Hyaluronic acid; conventional implant placement
Intervention type(s): Other; Other
Intervention description(s): immediate placement of dental implant after topical application of hyaluronic acid on implant surface; immediate placement of dental implant without application of hyaluronic acid on implant surface
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Twenty implants were inserted in patients seeking for replacement of missed single or multiple posterior maxillary teeth. Patients were divided randomly into two groups. In the control group, ten implants were placed and immediately loaded. While in the study group, ten implants were coated with hyaluronic acid (HA) immediately before placement and immediately loaded. All patients were clinically evaluated at implant placement time, one, three and six months after loading regarding implant stability. Peri-implant pocket depth and modified sulcus bleeding index were evaluated clinically at six months in all patients. Bone density was evaluated radiographically after three months. All clinical and radiographic data were subjected to statistical analysis.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Hyaluronic Acid, dental implant
Morpho-functional Changes After Oral Supplementation of Antioxidants and Anti-inflammatory Treatment in Age-Related Macular Degeneration.
Condition: Dry AMD
MeSH terms: Macular Degeneration
Study type: Interventional

Summary: 
      In patients with AMD a deterioration of the antioxidant mechanisms of the retina is observed
      and therefore an increase in the production of free radicals responsible for tissue damage.

      The Age-Related Eye Disease Study (AREDS) found that the intake of antioxidants reduces the
      risk of progression of the disease to an advanced stage (choroidal neovascularization or
      geographic atrophy ) and reduces the loss of visual acuity.

      In this study the investigators want to analyze the functional retinal changes (mfERG) of the
      macular region, in patients with dry age-related macular degeneration, after the use for 6
      months of an oral supplementation based on Ganoderma lucidum (Reishi), Calendula Officinalis,
      Lutepure-Marigold ( 5% Lutein and 1% Zeaxanthin) Blueberry, Rutin, Alpha-lipoic acid,
      Bromelain, NAC, Vtiamine C, B9, B12, D3, Selenium, Zinc and Copper.
    


Intervention name(s): Macuprev Group; Placebo Group
Intervention type(s): Other; Other
Intervention description(s): oral supplementation (Macuprev) 2 capsules per day for 6 months; oral placebo 2 capsules per day for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: monocentric, prospective, double blind randomized six months study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oral supplementation; mfERG; OCT
Pediatric ACTION3 (Identify, Treat, Control): Effectiveness of Adding Montelukast in Pediatric Subjects With Uncontrolled Asthma (0476-385)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      a study to describe patient and physician satisfaction with montelukast therapy for the
      control of asthma used either as monotherapy or in combination with inhaled corticosteroids
    


Intervention name(s): montelukast sodium
Intervention type(s): Drug
Intervention description(s): Montelukast 4-5 mg for 12 weeks, oral tablet
Other intervention name(s): Singular
Intervention MeSH terms: Montelukast
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
Condition: Dyskinesia; Levodopa Induced Dyskinesia; Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group
      study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral
      capsules, an extended release formulation of amantadine, dosed once daily for the treatment
      of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel
      pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma
      concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms
      of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may
      reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and
      iii) a reduced initial rate of rise in plasma concentration, which is expected to improve
      overall tolerability of amantadine.
    


Intervention name(s): ADS-5102 (extended release amantadine HCl)
Intervention type(s): Drug
Intervention description(s): Oral capsules to be administered once daily at bedtime, for 8 weeks
Intervention MeSH terms: Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Levodopa-induced dyskinesia; Parkinsonism
Mindfulness Based Stress Reduction for High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Nearly 60 million adults in the United States have high blood pressure (BP) in the
      pre-hypertension (SBP 120-139 or DBP 80-89). Hypertension is estimated to account for 1 in 8
      deaths in the world, and in the US the direct and indirect costs of high BP are estimated to
      reach $59.7 billion in 2005. JNC-7 guidelines recommend lifestyle modifications for
      prehypertension, followed by antihypertensive medication if BP progresses to Stage I
      hypertension. Mindfulness-based Stress Reduction (MBSR) is an increasingly popular practice
      that has been purported to alleviate stress and treat certain health conditions. Some stress
      management therapies and one meditation therapy (e.g., Transcendental Meditation) have shown
      promise in reducing elevated BP, but MBSR has not been evaluated as a treatment for high BP.
      When added to lifestyle modification advice, MBSR may be an appropriate complementary
      treatment for prehypertension. However, prior to a large randomized clinical trial of MBSR
      for prehypertension and/or hypertension, pilot data is necessary to provide preliminary
      evidence of a treatment effect and to evaluate feasibility. This feasibility randomized
      clinical trial of MBSR for unmedicated prehypertension will provide preliminary evidence to
      support a larger randomized clinical trial by evaluating the feasibility and safety of MBSR
      as a complementary treatment for high BP and by documenting any treatment effect. Sixty
      patients with unmedicated BP in the range of SBP 120-139 mm Hg or DBP 80-89 mm Hg will be
      randomly assigned to MBSR or a progressive muscle relaxation control condition. All patients
      will receive lifestyle modification advice. Patients will complete 8 weeks of MBSR delivered
      in a group format by an experienced psychologist trained in MBSR or 8 weeks of progressive
      muscle relaxation training matched for therapist contact and homework. Patients BP will be
      assessed prior to randomization and following treatment by researchers blind to treatment
      assignment. Accrual rates, acceptance of randomization, treatment adherence, treatment
      fidelity, and patient satisfaction with treatment will be evaluated.
    

Detailed description: 
      See brief summary
    

Intervention name(s): Mindfulness based stress reduction; Progressive Muscle Relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 weeks group MBSR; 8 weeks PMR in group format
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique
Condition: Arteriovenous Fistula, Cannulation
MeSH terms: Arteriovenous Fistula; Fistula
Study type: Interventional

Summary: 
      Infiltrations from cannulation difficulties result in significant morbidity including loss of
      vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and
      VA characteristics. Surface marking of VA lacks real-time information and traditional
      ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic
      Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD)
      approved for VA cannulation. Study is a single center randomized, prospective pilot study
      comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard
      cannulation practices.
    


Intervention name(s): Sonic Window ultrasound device
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that quetiapine SR (SEROQUEL®) is efficacious and
      safe in the acute treatment of patients with Generalized Anxiety Disorder.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine fumarate
Intervention type(s): Drug
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GAD; anxiety
Safety and Effectiveness of Banked Cord Blood or Bone Marrow Stem Cells in Children With Cerebral Palsy (CP).
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the safety and effectiveness of two types of stem
      cells,(either banked cord blood or bone marrow), in children between the ages of 2 to 10
      years with CP. 15 children with banked cord blood at CBR and 15 children without banked cord
      blood will be enrolled into the study. The study involves one baseline/treatment visit and 3
      follow-up visits at 6 months, 12 months, and 2 years. Five children in each group will be
      randomized to a placebo control group at the baseline/treatment visit. Parents will not be
      told if their child received stem cells or a placebo until the 12 month follow-up visit. At
      that time parents may elect to have their child receive the stem cell treatment; either bone
      marrow harvest or umbilical cord blood if banked with CBR. All study visits will be conducted
      at the UTHealth Medical School and Children's Memorial Hermann Hospital in Houston, Texas.

      As of 1/21/2014 we have met our enrollment limit for children without banked cord blood
      undergoing bone marrow harvest for stem cells.
    


Intervention name(s): umbilical cord blood (hUCB) cells; Saline Infusion (Placebo); bone marrow derived mononuclear cells (BMMNCs)
Intervention type(s): Biological; Drug; Biological
Intervention description(s): Autologous umbilical cord blood banked with the Cord Blood Registry.; A total of 10 children (5 from each cohort) will be randomized to a placebo infusion at the baseline visit and then have the opportunity to cross-over to stem cell treatment at the 1yr. visit.; Autologous stem cells from bone marrow harvest.
Other intervention name(s): Autolgous Stem Cells; Autologous Stem Cells
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Brain Injury; Stem Cells; Mononuclear Cells; Bone Marrow; Umbilical Cord Blood
A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to explore the tolerability, safety and efficacy of flexibly
      dosed paliperidone extended release (ER) among patients with schizophrenia.
    

Detailed description: 
      This is a single arm (the same intervention is given to all patients), multicenter study that
      aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone
      extended release (ER) among Filipino patients with schizophrenia who have not taken any
      antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not
      taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs
      that are helpful in the treatment of psychosis and have a capacity to ameliorate thought
      disorders. Flexible dosing allows the investigators to adjust the dosage of each patient
      based on the individual needs.
    

Intervention name(s): Paliperidone ER
Intervention type(s): Drug
Intervention description(s): Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
Intervention MeSH terms: Paliperidone Palmitate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Paliperidone ER; Treatment naive patients; Newly diagnosed patients
Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The study proposes to evaluate the feasibility of a preconception intervention comprising two
      proven interventions for reducing blood pressure; Beetroot juice; a source of dietary nitrate
      which reduces BP by 8/4mmHg after 4 weeks(6); Personalised resistance and endurance exercise
      programme (as per CMO recommendations) which reduces BP by ~10/5mm Hg over 8-12 weeks (7).
    

Detailed description: 
      A feasibility study will be conducted for a randomised, controlled trial of preconception
      interventions.

      The study will advertise using posters, social media and on departmental emails at Imperial
      College Healthcare NHS Trust or Imperial College for women aged 18-45 planning a pregnancy at
      any time in the future.

      The study will randomise women to 1 of 4 arms Arm 1: Exercise intervention for weeks 1-12 Arm
      2: Beetroot juice for weeks 1-12 Arm 3. Exercise and Beetroot juice for weeks 1-12 Arm 4:
      Control group

      Women will be provided with daily Beetroot juice shots (as per study arm), membership to an
      Everybody Active centre close to their home, personal training sessions to tailor an exercise
      program to them (2 initial sessions then monthly), a wearable to track their physical
      activity and a home BP monitor.
    

Intervention name(s): Beet It shots; Exercise; Control group
Intervention type(s): Dietary Supplement; Behavioral; Other
Intervention description(s): In addition to the procedures for the control group, women will be supplied with 84 Beet-It shots which they will be asked to take every morning with breakfast for 12 weeks. Women below 60kg will be advised to take a proportion of the 'shot' in order to comply with European Commission Accepted Daily Intake for nitrate, the active ingredient, of 0-5mg/kg. https://www.beet-it.com/product/beet-it-sport-shot/; In addition to the procedures for the control group, women will be supplied with gym membership for 12 weeks, 2 initial personal training sessions to design a personal exercise program followed by monthly personal training sessions.; Women will be supplied with a wearable device to measure physical activity, weighing scales and a home blood pressure monitor. They will be asked to record minutes of physical activity, exercise undertaken, resting blood pressure, resting heart rate and weight daily for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Blood pressure; Pre-conception; Hypertension; Exercise; Beetroot; Wearable
Translation and Validation of Pelvic Girdle Questionnaire in Urdu Language
Condition: Pelvic Girdle Pain
MeSH terms: Pelvic Girdle Pain
Study type: Observational [Patient Registry]

Summary: 
      Urdu version of pelvic girdle questionnaire was drafted, tested for its reliability and
      validity on patients with pelvic girdle pain. Urdu version was linguistically acceptable and
      accurate for pregnant and post partum females with pelvic girdle pain. The result seems
      comparable to all the other versions and especially with original Norwegian version. This
      instrument is understandable and easy to find disability during pregnancy and post partum
      duration. It showed a good content, construct and convergent validity also present high
      internal consistency and test retest reliability.
    

Detailed description: 
      The Pelvic Girdle Questionnaire is the only specific instrument designed to evaluate pain and
      activity limitations in pregnant or postpartum women with pelvic girdle pain. This study
      aimed to translate the Pelvic girdle questionnaire in Urdu language for Pakistani female
      patients and to verify the validation of the psychometric items of the Pelvic girdle
      questionnaire in population of Pakistan. The purpose of this study was to translate the
      Pelvic Girdle Questionnaire into Urdu and find out cross-culture validity and reliability of
      Urdu Pelvic girdle questionnaire among pregnant and postpartum females. A cultural adaptation
      and translation study was performing according to international guidelines. Study was
      conducted at different hospital settings. Pre test was conducted among 16 females during
      pregnancy & post-partum.

      Key words: Disability Evaluation, Female, Urdu, Pelvic Girdle Pain and physiopathology,
      Pregnancy, Surveys and Questionnaires, Translation.
    

Intervention name(s): Straight leg raise
Intervention type(s): Other
Intervention description(s): Diagnostic test, tool for *g*
Other intervention name(s): Pelvic girdle questionnaire
Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Female pregnant and post partum with pelvic girdle pain
Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      In this randomised, placebo-controlled, double-blind Phase 2a study, healthy male and female
      participants 18-50 years of age will be given an investigational RSV vaccine (RSVpreF) and
      challenged with RSV one month later. The purpose of this research study is to assess the
      safety, immunogenicity and efficacy of RSVpreF using a human viral challenge model.
    

Detailed description: 
      Respiratory Syncytial Virus (RSV) is a common virus that affects all human age groups and can
      cause a range of respiratory disease such as bronchitis and lower respiratory infections.
      These serious illnesses affect infants and adults who are older especially if they are over
      65, have chronic heart or lung disease or have a weakened immune system. Vaccination against
      RSV has the potential to be a highly beneficial and effective approach to reduce RSV disease
      in older adults and pediatric populations, however there is no current vaccine approved for
      the prevention of RSV infections.

      RSVpreF is being developed to prevent RSV-associated moderate to severe lower respiratory
      tract disease in adults 60 years of age and in infants by active immunization of pregnant
      women.

      This study is an exploratory proof-of-concept to assess the safety, immunogenicity and
      efficacy of RSVpreF using a human challenge model. The RSV challenge model is developed to
      help understanding the RSV disease and assess new vaccines by testing them in participants
      deliberately infected with the virus.

      In this study, approximately 62 (up to 72) participants will be vaccinated with the
      investigational RSVpreF to account for withdrawals between vaccination and challenge.
      Participants will be randomised 1:1 to receive RSVpreF or placebo.

      The study will consist of a vaccination phase, quarantine phase and a follow-up phase.
    

Intervention name(s): RSVPreF; Placebo
Intervention type(s): Biological; Other
Intervention description(s): A single dose of 120 mcg RSVpreF for intramuscular injection; A single Placebo dose for intramuscular injection to match experimental vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention