bioihbjkbjnl/mcl2 huggingface dataset:
Registry for Study of Coils in Intracranial Aneurysms
Condition: Cerebral Aneurysms
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Observational

Summary: 
      The current proposal describes a post-market, clinical registry of HydroSoft, aimed at
      gaining robust clinical data in a large set of patients to better define the advantages, and
      potentially, the disadvantages of the HydroSoft, and to inform future randomized trials.
    

Detailed description: 
      Aim 1. (Primary Outcome) To test the hypothesis that HydroSoft coils lead to diminished rates
      of aneurysm recurrence relative to bare platinum coils. In order to test this hypothesis, we
      will compare recanalization or recurrence rates observed in this prospective registry of
      HydroSoft coils used as finishing coils to historical series of aneurysms treated with bare
      platinum coils. This registry is designed to achieve 80% power to detect a minimally
      clinically relevant difference in rates of recurrence between HydroSoft-treated aneurysms
      compared with bare platinum coils. Based on recent, prospective, randomized trials assessing
      both bare platinum coils and hydrogel-bearing coils with 25% and 15% recurrence rates,
      respectively, we predict a recurrence rate of 18% for HydroSoft treated aneurysms. Typically,
      a "minimally clinically relevant difference" is on the order of a 30% diminution in a given
      undesirable outcome. As such, the registry is well powered to detect this minimally
      clinically relevant difference (18% expected recurrence rate for HydroSoft treated coils
      versus 25% for the historical control group).

      Aim 2. (Secondary Outcome 1) To test the hypothesis that the HydroSoft embolic coil can be
      placed reliably in intracranial, saccular aneurysms, even late in the embolization procedure.
      Success of this aim is defined as ease of placement of the HydroSoft device, without need for
      coil removal and subsequent "finishing" with a bare platinum coil.

      Aim 3. (Secondary Outcome 2) To test the hypothesis that use of the HydroSoft embolic coil is
      associated with risks of thromboembolism similar to that with other coil types, on the order
      of 3-5% or less.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All people with cerebral aneurysms between the ages of 21 and 90 that are treated with
        coils.
      
Keywords: aneurysm; coils
Difficult Intravenous Access Perception: Difficult IV Access - Assessment of Patient Understanding
Condition: Understanding Emergency Room Procedures
MeSH terms: Emergencies
Study type: Observational

Summary: 
      Aim: Patient Perception: This aim broadly intends to use traditional script versus a brief
      video education vignette to determine understanding and preferences among general emergency
      department patients of rescue access techniques. A challenge of emergency care is providing
      patient education surrounding procedures in a standardized and patient-oriented manner. This
      data would provide insight on a patient's understanding of the risks and benefits of rescue
      access, assess patient preference, and potentially influence what rescue technique is
      employed in the future. This information may also give us insight onto why DIVA patients
      might refuse randomization.
    


Intervention name(s): Survey
Intervention type(s): Other
Other intervention name(s): Patients will complete a survey to assess their understanding and preferences.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible for enrollment would be any hemodynamically stable adult 18 years of age or older
        who is a HUP Emergency Department patient, able to provide informed consent, without
        history of difficult intravenous access, and able to speak, read, hear, and speak English
        fluently.
Acceptance and Commitment Therapy for Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Insomnia is a frequent complaint and is associated with impairments in physical and
      psychological health. Although Cognitive-Behavioral Therapy (CBT) demonstrates effective
      results for insomnia, there are those who do not respond to this type of intervention or
      present difficulties in adherence. Acceptance and Commitment Therapy (ACT) presents itself as
      a potentially useful intervention for the treatment of insomnia, for which, instead of
      focusing on controlling the symptoms, the respective approach focuses on accepting the
      feelings and thoughts associated, through value-based actions. The aim of this study is to
      evaluate the effectiveness of ACT for chronic insomnia in adults. Participants will be 150
      adults aged between 18 and 59 years, diagnosed with chronic insomnia who will be randomly
      assigned to the ACT, CBT and wait list (WL) groups. For both groups (ACT and CBT), the
      intervention will be performed in six group and weekly sessions. Assessments of sleep
      patterns, insomnia, depression, anxiety, psychological flexibility, acceptance of sleep,
      beliefs about sleep, personality traits will be performed in the pre-treatment,
      post-treatment and six-month follow-up. After the intervention is completed, participants
      will respond to an inventory of compliance and satisfaction. Treatment effects will assessed
      using the fixed effects of group variables (ACT vs. CBT-I and ACT vs. waitlist) and their
      interaction with time (pre-test vs. post-test and pretest vs. six-month follow-up). Estimated
      pairwise contrasts to examine changes across time within groups will be used. Variables will
      analyzed using generalized mixed models (GMM).
    


Intervention name(s): Acceptance and Commitment Therapy for Insomnia; Cognitive Behavioral Therapy for Insomnia
Intervention type(s): Behavioral; Behavioral
Intervention description(s): ACT-I treatment group: Participants diagnosed with chronic insomnia will receive group treatment. The six sessions will be aimed at psychoeducation about sleep added to the therapeutic processes of acceptance, mindfulness, availability, values, defusion and commitment, used in ACT.; Active control group CBT-I: Participants diagnosed with chronic insomnia will receive treatment in a group. The six sessions will be aimed at cognitive-behavioral components, such as education and sleep hygiene, stimulus control, sleep restriction and demystification / restructuring of belief beliefs.
Other intervention name(s): ACT-I; CBT-I
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: INSOMNIA; acceptance and commitment therapy; Cognitive behavioral therapy; SLEEP
Blood Flow Restriction Resistance Exercise in Lower Cervical Spinal Cord Injury Patients
Condition: Cervical Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      This study is conducted to investigate the effects of low load Blood Flow Resistance exercise
      to improve strength and transfer in lower cervical spinal cord injury patientsCervical Spinal
      Cord injury patients have very less window of opportunity towards functional mode of life. In
      complete cervical spinal cord injuries only few muscles of upper limb are completely
      innervated and it is a need to gain maximum output and advantage out of that. Through
      conventional strength training it is possible to make him do unsupported sitting and transfer
      But with BFR-RE it may have a possibility to do this procedure in less time than the
      conventional strength training and patient will save cost of hospital stay as he may timely
      discharge from hospital early
    


Intervention name(s): Blood flow restriction; Conventional physical therapy
Intervention type(s): Other; Other
Intervention description(s): strengthening protocol but with Blood flow restriction technique
.Standard BFR Application: a standard pressure (used for all patients) for e.g. 180
mmHg; a pressure relative to the patient's systolic blood pressure, for e.g. 1.2 - or 1.5-fold greater than systolic blood pressure.40% cuff pressure as percentage of LOP.(4) And performing BFR-RE with low load exercises. So 30% of 1 RPM would be enough 4 times a week for 6 week; Resistance exercise 75 repetitions across four sets of exercises, with30 repetitions in the first set and 15 repetitions in each subsequent set. 4 times a week for 6
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics, Safety, and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Single Tablet Regimen (STR) in Adolescents
Condition: Acquired Immunodeficiency Syndrome; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The primary objectives of this study are to evaluate the steady-state pharmacokinetics (PK)
      and confirm the dose of the elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil
      fumarate (EVG/COBI/FTC/TDF) single-tablet regimen (STR) (Part A) and to evaluate the safety
      and tolerability of EVG/COBI/FTC/TDF STR through Week 48 (Part B) in HIV-1 infected,
      antiretroviral (ARV) treatment-naive adolescents.

      A total of 50 adolescent participants (12 to < 18 years of age) will be enrolled to receive
      EVG/COBI/FTC/TDF as follows:

        -  Part A: Twelve to 16 eligible participants will be enrolled to evaluate steady-state PK,
           and confirm the dose, with the intent to enroll at least 4 participants 12 to < 15 and
           at least 4 participants 15 to < 18 years of age.

        -  Part B: Following confirmation of EVG exposure in at least 12 participants from Part A,
           34 to 38 participants in addition to those enrolled in Part A will be enrolled to
           evaluate the safety, tolerability, and antiviral activity of EVG/COBI/FTC/TDF STR.
    


Intervention name(s): EVG/COBI/FTC/TDF
Intervention type(s): Drug
Intervention description(s): 150/150/200/300 mg STR administered orally once daily with food
Other intervention name(s): Stribild®
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents; HIV-1; HIV; Treatment Naive
Evaluation of the Safety and Biologic Effects of an Eicosapentaenoic (EPA)-Enriched Oil
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal is to test the safety and efficacy of an EPA-enriched oil made by DuPont. DuPont
      wishes to corroborate the safety of its novel oil rich in EPA in humans prior to placing such
      a dietary supplement on the market. The goal of this study is to test this oil at doses of
      600 mg and 1800 mg of EPA/day as compared to olive oil placebo and a comparator oil providing
      600 mg of DHA/day over a 6 wk period. In a parallel arm study design, 120 healthy adults will
      be randomized to one of four groups (30 in each group) and studied in both the fasting and
      post-prandial state.
    

Detailed description: 
      The safety profile of omega-3 fatty acids is considered to be excellent, and has been
      recognized as safe (GRAS) by the US Food and Drug Administration when EPA and DHA
      (docosahexanoic acid) are given together at a dose of 3 grams/day or less. Safety will be
      monitored by assessing for adverse reactions, measuring vital signs and a variety of
      laboratory tests including a complete metabolic profile and complete blood count. Efficacy
      will be assessed by measuring changes in fatty acid profile and or fatty acid ratios.

      The goal of this study is to test this EPA oil at doses of 600 mg and 1800 mg of EPA/day as
      compared to olive oil placebo and a comparator oil providing 600 mg of DHA/day over a 6 wk
      period. In a parallel arm study design, 120 healthy adults will be randomized to one of four
      groups (30 in each group) and studied in both the fasting and post-prandial state.
    

Intervention name(s): EPA 600; EPA 1800; Olive Oil; DHA
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): EPA 600 mg/day for 6 weeks; 1800 mg/day for 6 weeks; 600 mg/day for 6 weeks; 600 mg/day for 6 weeks
Other intervention name(s): omega 3 fat; fish oil; omega 3 fat; fish oil; Oleic acid; omega 3 fat; fish oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Disease Risk Reduction
Histological Assessment of BMAC Utilized in Sinus Lift
Condition: Implant Site Reaction
Study type: Interventional

Summary: 
      Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus
      membrane augmentation on bone quality and quantity. Methodology: sixteen patients suffering
      from atrophic posterior maxilla with sinus pneumatization were randomly divided into two
      equal groups: study group: the sinus membrane was elevated with BMAC/bovine graft whereas the
      control group recieved bovine graft only for sinus floor augmentation.

      All patients will be evaluated at 1 week, 4 months to measure bone height and bone core
      biopsy for histological assessment at 4 months during implant placement.
    

Detailed description: 
      Aim : The aim of present study was to evaluate BMAC/bovine graft utilization in Sinus
      membrane augmentation on bone height gain and quality of bone on histological assessment.

      Methodology: sixteen patients suffering from atrophic posterior maxilla with sinus
      pneumatization were randomly divided into two equal groups: study group: the sinus membrane
      was elevated with bone marrow aspirate concentrate loaded on bovine graft whereas the control
      group recieved bovine graft only for sinus floor augmentation.

      All patients will be evaluated at 1 week, 4 months by CBCT to measure bone height and bone
      core biopsy for histological assessment at 4 months during implant placement.
    

Intervention name(s): BMAC loaded on bovine graft; Bovine graft only
Intervention type(s): Drug; Drug
Intervention description(s): Bone marrow aspirate concentrate loaded on bovine graft for sinus floor augmentation; Bovine graft only for sinus floor augmentation
Other intervention name(s): Bone marrow aspirate concentrate loaded on bovine graft; Unloaded bovine graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bone marrow; Sinus augmentation; Sinus lift
A Study in Type 2 Diabetics of Single and Multiple Doses of Orally Administered GSK1292263 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if GSK1292263 is safe and well-tolerated when
      administered to type 2 diabetics, and to get preliminary information about whether it may be
      effective in the treatment of type 2 diabetes.
    

Detailed description: 
      Data from this study will be used to assess the potential of GSK1292263 as a treatment for
      T2DM, and will aid the design and dose selection of future studies of longer duration in T2DM
      subjects that will evaluate GSK1292263 alone or in combination with other anti-diabetic
      drugs.
    

Intervention name(s): GSK1292263; GSK1292263 matching placebo; Sitagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GSK1292263 is an immediate-release round, white, film-coated tablet provided in 3 strengths, 25mg, 75mg and 200mg being developed for the treatment of type 2 diabetes.; Matching placebo to active drug GSK1292263; Sitagliptin (Januvia) 100mg tablets are beige, round, film-coated tablets with "277" on one side.
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Tolerability; Pharmacokinetics; Safety; Pharmacodynamics; Glucose
Autologous Bone Marrow Stem Cell Therapy for Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow
      mononuclear stem cells in the management of autism.
    

Detailed description: 
      The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow
      mononuclear stem cells in the management of autism of 24 patients at Vinmec International
      Hospital, Hanoi, Vietnam
    

Intervention name(s): Autologous Bone Marrow Mononuclear Cells
Intervention type(s): Biological
Intervention description(s): Transplantation of Autologous Bone Marrow Mononuclear Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism; Stem Cells
Effect of Trunk Stabilization Exercises on Quality of Life and Communication in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      To investigate the effectiveness of neck and trunk stabilization exercises on communication
      and quality of life (QoL) in children with cerebral palsy (CP) with oral motor problems.
      Children with CP were randomly divided into Study Group (SG) and Control Group (CG).
      Neurodevelopmental treatment (NDT) approaches and oral motor therapy were applied to both
      groups. SG also received neck-trunk stabilization training.
    

Detailed description: 
      In the multidisciplinary approach, special approaches to secondary problems, oral-motor
      trainings and communication studies are used in addition to Neurodevelopment treatment
      approach in the treatment of children with CP. Because of their impact on postural control,
      neck-trunk stabilization exercises are very important for therapeutic interventions designed
      to improve quality of life with activities of daily living.

      As the increases in neck muscle strength are related to trunk stabilization, trunk
      stabilization exercises are thought to have positive effects on neck muscle strength. In
      addition, since the neck and trunk are complementary to each other, it is supported by the
      literature that neck stabilization exercises and trunk stabilization exercises should be
      applied together.
    

Intervention name(s): Neurodevelopmental treatment (NDT); Feeding and oral-motor intervention strategies; Neck and trunk stabilization exercises
Intervention type(s): Other; Other; Other
Intervention description(s): NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.; Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.; Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure). All of these affect communication and quality of life.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Trunk Stabilization Exercises; Oral Motor; Quality of Life; Communication
Study to Evaluate a Single Dose of Apixaban in Pediatric Participants at Risk for a Thrombotic Disorder
Condition: Thromboembolism
MeSH terms: Thromboembolism; Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      CV185118 is a single dose Apixaban PK/PD study in pediatric participants. The objective of
      this study is primarily to study the PK/PD of Apixaban in pediatric participants at risk for
      thrombosis
    


Intervention name(s): Apixaban
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Other intervention name(s): BMS-562247
Intervention MeSH terms: Apixaban
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Testing of Cognitive Behavioral Therapy Resource of Turkish Version
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study aimed to evaluate the cognitive behavioral therapy source of Turkish version of
      the 'message to dentist' (MTD) with children attending two dental settings.
    

Detailed description: 
      Children aged 5-16 years attending a dental faculty clinic and a private dental office were
      invited to complete the MTD form. Children were asked to report how worried they felt, their
      level of pain they anticipated and the actual level of pain they experienced on a scale of
      1-10 (with 1 being the best outcome).
    

Intervention name(s): Cognitive Behavioral Therapy form for dental anxiety
Intervention type(s): Behavioral
Intervention description(s): Message to Dentist form
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dental anxiety; cognitive behavioral therapy; pediatric dentistry