bioihbjkbjnl/mcl2 huggingface dataset:
Traumastem® Versus Surgicel® for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection
Condition: Liver Hemorrhage
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Topical hemostats are agents that stop bleeding by contributing blood to clot. Oxidized
      cellulose, a sort of mechanical hemostatic material, predominantly forms a block to stop the
      blood flow and provides a surface to clot more rapidly.It was marketed for the first time in
      1945 and widely used for its convenience, biocompatibility, and bactericide from that time.
      It is currently available in many commercial products, while manufactured using either a
      regenerated or nonregenerated process. The physicochemical property and hemostatic efficacy
      of oxidized regenerated cellulose (ORCG) and oxidized nonregenerated cellulose (ONRCG) has
      been well documented using in vitro test and animal models, and ONRCG was seemingly superior
      to ORCG in terms of hemostasis. However, no clinical study has been performed to verify.
      Therefore, the objective of this prospective randomized study is to assess the hemostatic
      efficacy of ORCG (Surgicel®, Ethicon) vs ONRCG (Traumastem®, Bioster) for hemostasis of local
      bleeding in patients undergoing hepatic resection.
    

Detailed description: 
      Representative liver resected surface (prominent bleeding site) was applied the ply of gauze
      with several seconds of even finger gentle press under aseptic conditions, then it was
      untouched and observed for 10 min. Vascular occlusion of the liver was allowed if necessary,
      but was open for evaluation of hemostatic efficacy. Hemostatic time began to calculate when
      gauze was applied. Time to hemostasis was recorded in seconds and the maximum time to
      hemostasis was 600 seconds. Hemostasis success was achieved based on there was no visible
      bleeding or minimal ooze from the resection wound.
    

Intervention name(s): Traumastem®; Surgicel®
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Intraoperative application as secondary hemostatic treatment; Intraoperative application as secondary hemostatic treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Liver resection; Liver Hemorrhage; Traumastem; Surgicel
Myeloablative Haploidentical BMT With Post-transplant Cyclophosphamide for Pediatric Patients With Hematologic Malignancies
Condition: Myeloablative Conditioning; HLA-mismatched Bone Marrow Transplantation; Graft Survival; Transplantation, Bone Marrow
MeSH terms: Hematologic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-institutional phase II haploidentical T cell replete bone marrow transplant
      (BMT) study in children with high-risk leukemia. The myeloablative conditioning regimen
      prescribed will be Total body irradiation (TBI)-based for lymphoid leukemia and
      busulfan-based for myeloid leukemia. Our goal is to establish an easily exportable,
      inexpensive platform for haplotransplantation that has a safety profile equivalent to matched
      related and unrelated BMTs. The primary objective will be to estimate the incidence of
      6-month non-relapse mortality (NRM), hypothesizing that NRM is < 18%.
    

Detailed description: 
      This is a phase II prospective study designed to evaluate the incidence of 6 month non-
      relapse mortality, safety, and feasibility of haploidentical bone marrow transplantation
      (BMT) after myeloablative conditioning with post-transplant Cy. Conditioning regimens include
      a total body irradiation (TBI)-based prep for lymphoid leukemias and a chemotherapy based
      prep for myeloid leukemias.

      To estimate the incidence of non-relapse mortality at 180 days following myeloablative
      haploidentical BMT for children and young adults with high risk hematologic malignancies.
    

Intervention name(s): Cyclophosphamide; TBI; Busulfan; Unmanipulated Bone Marrow; Tacrolimus; Mycophenolate mofetil
Intervention type(s): Drug; Radiation; Drug; Other; Drug; Drug
Intervention description(s): Chemotherapy administration; Radiation Therapy; Chemotherapy Administered; Bone Marrow Transplant; Immunosuppressive Drug Administered; Immunosuppressive Drug Administered
Other intervention name(s): Cy; Bu; tacro; MMF
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Busulfan; Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute lymphoblastic leukemia; Acute myeloid leukemia; Juvenile myelomonocytic leukemia; Treatment related leukemia; Biphenotypic leukemia
Effect of Exercise Intervention on Body Composition and Quality of Life in Post-bariatric Surgery Patients
Condition: Exercise
Study type: Interventional

Summary: 
      This study will investigate the effectiveness of a rehabilitation program in improving body
      composition, and quality of life in patients with bariatric surgery in Taiwan.

      Hypothesis:

        1. The body composition in exercise group is significant improving than control group at 1
           weeks, 1st, 2nd, and 3rd month.

        2. The quality of life in exercise group is significant improving than control group at 1
           weeks, 1st, 2nd, and 3rd month.
    

Detailed description: 
      This study will investigate the effectiveness of a rehabilitation program in improving body
      composition, and quality of life in patients with bariatric surgery in Taiwan.
    

Intervention name(s): Exercise education
Intervention type(s): Other
Intervention description(s): weekly telephone or mobile application "LINE" consultations concerning exercise. we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Both groups were tested by demographic characteristics, dietary behavior measurement, SF-36 Questionnaire and body composition analyzer for the same project. The experimental group needs to cooperate with the moderate-intensity walking exercise training prescription for 3 times a week ; Control group no exercise intervention.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Bariatric surgery; Body composition; Morbid obesity; Quality of life; Walking exercise
Oral Bioavailability of Curcumin From Micronized Powder and Liquid Micelles in Healthy Young Women and Men
Condition: Pharmacokinetics of Novel Curcumin Formulations; Safety of Novel Curcumin Formulations
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Background: The oral bioavailability of curcumin is low due to its limited intestinal uptake,
      rapid metabolism and excretion from the body. Considering its potent reported
      health-beneficial properties, researchers have tried to increase its bioavailability as a
      means to enhance its biological activities.

      Objective: The aim of the project was to develop novel curcumin formulations with enhanced
      oral bioavailability and to study the safety of the formulations and potential
      sex-differences in humans.

      Design: In this single-blind crossover study with three arms separated by ≥1-week washout
      periods, healthy subjects (13 women, 10 men) were provided standardized meals and took, in
      random order, a single oral dose of 500 mg curcumin as native powder, micronized powder, or
      liquid micelles. Blood and urine samples were collected in intervals for 24 h and total
      curcumin, demethoxycurcumin, and bis-demethoxycurcumin were quantified.
    


Intervention name(s): curcumin
Intervention type(s): Dietary Supplement
Intervention description(s): 500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: bioavailability; curcumin; curcuma longa; healthy humans; safety; sex differences
Validity and Reliability Study of the Muscle Excitability Scale in Spinal Cord Injury Patients
Condition: Spasticity, Muscle; Spinal Cord Injuries
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      The aim of the study is to verify validity and reliability of the Muscle excitability scale
      (MES), which has been developed to access muscle susceptibility to spasms and/or clones as
      part of spastic motor behavior in spinal cord injured patients.
    

Detailed description: 
      The muscle excitability scale (MES) is intended for patients after spinal cord injury. The
      objective is to evaluate a motor response (muscle spasms or clones) to a sensory or motor
      stimulus. A sensory stimulus is created by thumb and pointfinger compression of cutaneous
      tissue on the inside part of the middle thigh and calf. A motor stimulus is created by
      passive movement of the lower limb to flexion and extension. The MES grades from 0 to 4
      reflect the muscle spastic or clonic tendency and the extent of this motor response (from
      isolated to generalized). Two investigators will examine a spastic motor behavior in 50
      chronic SCI subjects using MES, Modificated Ashworth Scale (MAS) and Penn Spasms Frequency
      Scale (PSFS) to verify the validity and reliability of the MES.
    

Intervention name(s): Manual examination
Intervention type(s): Procedure
Intervention description(s): With the patient in a supine position, squeeze the skinfold between your thumb and pointfinger on the inner aspect of the middle third of the thigh and on the inner aspect of the middle third of the calf.
Place your hand under the proximal calf and the heel and move the leg into maximum flexion at the hip and knee joints. After the response, if any, is completed, move the limb back into full extension. Each of these movements lasts for one second.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Spasticity in spinal cord injury
      
Keywords: Spasticity; Spinal cord injury; Validity; Reliability
Men's Prostate Awareness Church Training
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      The objective of the Prostate Cancer Education in African American Churches project is to
      develop and evaluate a spiritually-based educational intervention for Informed Decision
      Making (IDM) for prostate cancer screening to be delivered to African American men in church
      settings.
    

Detailed description: 
      The specific aims of the project are to 1) develop, and 2) test the efficacy of a
      spiritually-based cancer communication intervention to increase IDM for prostate cancer
      screening among African American men in church settings, and including women as supportive
      "health partners".

      A randomized controlled trial is utilized, in which churches will be randomized to: 1)
      male-only educational groups; and 2) co-educational groups where women supportive "health
      partners" are invited to attend with the men in dyads, and then break out into men's and
      women's discussion groups. These two approaches are compared through use of cluster
      randomized design to determine whether the addition of the women health partner increases the
      intervention efficacy in the study outcome of informed decision making for prostate cancer
      screening.
    

Intervention name(s): Men's Workshops; Co-Educational Workshops
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Two male Community Health Advisors will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part workshop series.; One male and one female Community Health Advisor will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part workshop series. Two break out sessions will occur in the Health Partner condition with separate discussion sessions for men and female health partners.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: prostate cancer disparities; African American; Spiritually based intervention; Men's Health; Informed Decision Making; Community Based Participatory Research; Health Communication; Health Information Technology; Community Health Advisors
Efficacy of the OrthoApnea NOA® Mandibular Advancement Device in the Management of Obstructive Sleep Apnea.
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The objective of this study is to assess the efficacy of the Orthoapnea NOA® mandibular
      advancement device and describe the percentage of advancement (%) needed to reach efficacy,
      and to retrospectively compare with other MAD designs in the management of obstructive sleep
      apnea. Additionally, to describe patient compliance and adherence to the therapy with the
      Orthoapnea NOA® device, and to assess the incidence and prevalence of signs, symptoms, and
      diagnosis of temporomandibular disorders (TMD) associated to the use of the Orthoapnea NOA®
      mandibular advancement device.
    


Intervention name(s): Orthoapnea NOA®
Intervention type(s): Device
Intervention description(s): The efficacy of the appliance for the management of OSA will be stablished based on two criteria. Criterion I: > 50% reduction of AHI/RDI. Criterion II: AHI/RDI < 5 events/hour or <15 events/hour with a significative reduction of OSA associates symptoms as defined before. Therapeutic failure will be established when at 100% of advancement of the device, there is less than 50% of reduction of the AHI/RDI with a residual AHI/RDI >5 events/hour with OSA associates symptoms.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OSA; Obstructive sleep apnea; mandibular advancement device; oral appliance
MVP RCT: Mind and Voice Project Randomized Control Trial
Condition: Physical Health; Mental Health; Alcohol; Use, Problem; Interpersonal Violence
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      The study seeks to learn more about the health behaviors of young adults. Health behaviors
      include relationships, physical and mental health, alcohol use, and conflicts with others.
      The purpose of this study is to improve prevention and intervention programs for young
      adults.
    


Intervention name(s): Resource pamphlet; Remote Therapy
Intervention type(s): Other; Behavioral
Intervention description(s): The pamphlet will list violence prevention, mental health, and substance abuse services.; Remote therapy sessions will include mindfulness exercises and motivational interviewing techniques.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study in Mild Asthmatic Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety and usefulness of GSK2190915 in
      asthmatic patients who develop asthma symptoms following being challenged.
    


Intervention name(s): GSK2190915 - 100mcg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor; Matching Intervention Drug
Other intervention name(s): GSK2190915
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: challenge; early asthmatic response; mild asthmatics; Allergen; methacholine
QEEG and Qualitative EEG for the Identidification of Abnormal Patterns in Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Observational

Summary: 
      Fibromyalgia is a relatively young condition recently recognized by the WHO as a separated
      clinical entity. Part of the medical comunity thinks of it as a mixed condition between
      depresion and rheumatic pain, however, functional data provided by sophisticated imaging
      techniques points at a diminished brain activity in several brain regions. The present study
      aims to characterize those findings by means of QEEG in order to establish the
      electroencephalographic characteristics of fibromyalgia patients.
    

Detailed description: 
      Fibromyalgia is a disease that part of the general population and even the medical community
      views with skepticism and only recently was accepted as a true condition by the World Health
      Organization. Some physicians see it as a form of depresion mixed with rheumatic pain.
      However recent findings in functional magnetic resonance imaging and positron emited
      tomography documented diminished brain activity on several regions. The impairments must be
      located within the areas with a documented functional defect, wherein, spontaneous braincells
      activity chould arise. Therefor electroencephalography findings should be a valuable
      diagnostic tool for early detection in fibromyalgia. The present study aims to analyse the
      differences between bioelectric characteristics in EEG from fibromyalgia patients with their
      eyes closed in a 21 electrode arragement. Normal graphoelements as well as abnormal ones and
      its topographic distribution and functional conections will be analyzed.

      The working hypotesis is that fibromyalgia patients will present distintive characteristics
      in the same areas where a diminished brain activity has been documented by metabolic and
      morphologic tests as a group and that those characteristics are suitable to be measured by
      QEEG and distinguishable from healthy subjects.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Men and women between 20 and 70 years old divided in two groups, one consisting in 50
        subjects diagnosed with fibromyalgia acording to the current criteria of the American
        College of Rheumatology and a control group matched by age and gender without fibromyalgia
      
Keywords: Fibromyalgia; QEEG; Brain activity; fMRI; Diagnosis
Developing Advanced Blood-Brain Barrier Permeability Imaging for Early AD
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      Aging is the primary risk factor in aging-related dementia. An important initiating factor
      for the development and progression of cognitive impairment is disruption of the blood-brain
      barrier (BBB). BBB plays an important role in maintaining normal brain homeostasis and
      protecting neural tissues from toxins. It is hypothesized that such changes known to be
      common in aging and can be an early process that precedes Alzheimer's Disease (AD). The
      microvascular changes related to subtle BBB disruption can be measured with
      permeability-surface area (PS) derived from GRASP DCE-MRI acquired less than 10 minutes, and
      the patterns of increased PS in normal and abnormal aging are different.
    


Intervention name(s): GRASP Dynamic Contrast-Enhanced (DCE) MRI; 3T Brain Scan; Gadolinium-based Contrast Agent (GBCA) for MRI
Intervention type(s): Device; Device; Drug
Intervention description(s): Golden-angle Radial Sparse Parallel (GRASP) DCE MRI is an MRI sequence designed to improve spatial and temporal resolution while enabling retrospective reconstruction with flexible temporal resolution.; Up to 60 minutes, a portion of which uses the GRASP DCE-MRI sequence.; Gadavist/Gadobutrol is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.
Other intervention name(s): Gadavist/Gadobutrol
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy cognitively normal control subjects of both age cohorts will be recruited by the
        study coordinator from (i) a pool of established volunteer subjects at NYU Langone Health
        who previously participated in research and who have agreed to be contacted about future
        research, (ii) Health Insurance Portability and Accountability Act of 1996
        (HIPAA)-compliant databases such as RedCap and DataCore, and (iii) individuals who have
        contacted NYU to express interest in participating in research as a healthy volunteer.

        Subjects with aMCI will be recruited by Dr. Wisniewski from an ongoing NIH-funded large
        grant at NYU Barlow Center.
Application of Transcranial Direct Current Stimulation (tDCS) for Gait Function Improvement of Parkinson's Disease Patient
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effect of simultaneous application of
      transcranial direct current stimulation (tDCS) and treadmill gait training for gait function
      recovery in Parkinson's disease patients with gait impairment.
    


Intervention name(s): Brain stimulation; Treadmill gait training
Intervention type(s): Device; Device
Intervention description(s): tDCS brain stimulation on leg motor areas was applied to Parkinson patients.; Treadmill gait training was applied to Parkinson patients.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transcranial direct current stimulation; gait training; Parkinson's disease
An Explorative Prospective Observational Study to Describe Morphokinetic De-selection Parameters in Human Embryos
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      This post-marketing, multi-center prospective study will be conducted in a open-label,
      non-interventional setting, for women seeking fertility treatment and will describe
      morphokinetic de-selection parameters in human embryos.
    


Intervention name(s): menotropin
Intervention type(s): Drug
Other intervention name(s): Menopur
Intervention MeSH terms: Menotropins
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women seeking fertility treatment
Outcomes Study of Late Effects After Proton RT for Pediatric Tumors of the Brain, Head, and Neck
Condition: Central Nervous System Tumors
MeSH terms: Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Brain Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to collect information from medical records to see what effects
      proton beam radiation has on cancer and analyze possible side effects.
    

Detailed description: 
      Data collection will be obtained from the patient's medical records including initial
      evaluation, radiotherapy completion records and follow-up.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients treated at a radiation oncology clinic
      
Keywords: Proton Radiation; Central Nervous System (CNS) Tumors; Brain; Spine; Cancer; Radiation Therapy (RT)