bioihbjkbjnl/mcl2 huggingface dataset:
Absolute Myocardial Perfusion Measurement in the Transplanted Heart
Condition: Cardiac Transplantation
Study type: Observational

Summary: 
      The goal of this study is to detect AR and CR in the transplanted heart by quantitative
      assessment of myocardial blood flow and its constituents by myocardial contrast
      echocardiography (MCE). Further we investigate the collateral circulation in these patients.
    

Detailed description: 
      Heart transplantation has become an accepted therapy for end-stage heart failure. Acute
      allograft rejection (AR) remains a major cause of mortality in heart transplant recipients.
      Chronic rejection (CR) determines the long-term prognosis after cardiac transplantation and
      is responsible for more than one third of late deaths. Different non-invasive methods have
      been evaluated for the detection of AR, but the gold standard remains endomyocardial biopsy
      (EMB).

      Very little is known about the impact of CR on the collateral circulation in transplant
      patients. Since the collateral circulation of the heart is mainly part of the
      microcirculation, it can be hypothesized that it is less developed than in "normal" coronary
      atherosclerosis without microvascular lesions.

      The quantification of CR with non-invasive techniques has remained difficult. In this
      context, there is a need for a reliable non-invasive test to avoid regularly invasive
      evaluation.

      Based on the above considerations we propose that both AR and CR can be accurately detected
      and differentiated using non-invasive quantitative myocardial contrast echocardiography
      (MCE).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Prospective study with consecutive inclusion of transplanted patients undergoing follow-up
        exams. Examinations comprise endomyocardial biopsy (EMB) and, partly, coronary angiography
        on the subsequent day. Group A patients (i.e. those without coronary angiography) undergo
        MCE and pharmacologic stress with adenosine, the results of which are compared with the EMB
        done at the same day. If they have an acute rejection, they are reexamined during a
        histologically proven rejection free period, and the results are compared with those
        obtained during acute rejection. Group B patients (i.e. with EMB and coronary angiography)
        undergo the same procedure as in group A. Additionally, coronary collateral flow index
        (CFI) is obtained and an IVUS exam is performed during coronary angiography.
Coagulation Parameters in Postmenopausal Breast Cancer Patients Under Adjuvant Hormonal Therapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The objective of the study is to monitor the changes of blood coagulation parameters in
      postmenopausal patients who are treated with adjuvant Hormonal Therapy for a total of 5
      years. The values of the standard coagulation parameters throughout the study will be
      compared with the baseline values.
    

Detailed description: 
      Study subjects will be treated with standard adjuvant hormonal therapy for a total of 5 years
      or until disease relapse or until HT is permanently discontinued for other reasons. The
      choice of endocrine treatment strategy (drugs to be used or their sequence, if the sequential
      option has been decided) is left at the discretion of the participating site. Adjuvant HT
      will commence after the completion of adjuvant chemotherapy and/or radiotherapy. Percentage
      change (%) from baseline of the blood coagulation parameters at 6, 12, 18, and 24 months of
      treatment. The blood coagulation parameters which will be measured are fibrinogen,
      prothrombin time (PT) and activated partial thromboplastin time (aPTT).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Postmenopausal, ER and/or PgR positive breast cancer patients eligible for adjuvant
        hormonal treatment (HT), who are admitted for treatment and follow-up at the participating
        sites, will be enrolled in the trial. Study subjects will be treated with standard adjuvant
        hormonal therapy for a total of 5 years or until disease relapse or until HT is permanently
        discontinued for other reasons.

        The choice of endocrine treatment strategy (drugs to be used or their sequence, if the
        sequential option has been decided) is left at the discretion of the participating site.
        Adjuvant HT will commence after the completion of adjuvant chemotherapy and/or
        radiotherapy.
      
Keywords: Aromatase Inhibitors; Coagulation parameters; Tamoxifen
Radiation Therapy in Treating Patients With Bile Duct, Gallbladder, or Pancreatic Cancer
Condition: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Motexafin
      gadolinium may increase the effectiveness of radiation therapy by making tumor cells more
      sensitive to treatment.

      PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus motexafin
      gadolinium in treating patients with bile duct, gallbladder, or pancreatic cancer that cannot
      be removed surgically.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety and toxicity of motexafin gadolinium (PCI-0120) when
      administered concurrently with radiotherapy in patients with locally advanced unresectable
      pancreatic or biliary tree tumors. II. Assess the pharmacokinetics of this regimen in these
      patients. III. Assess tumor uptake of PCI-0120 (by MRI signal characteristics) in these
      patients. IV. Determine the maximum tolerated dose of PCI-0120 in these patients. V.
      Determine the objective response (by radiologic criteria) in patients treated with this
      regimen.

      OUTLINE: This is a multicenter, dose-escalation study of motexafin gadolinium (PCI-0120).
      Patients receive PCI-0120 IV over 15 minutes 3 times weekly concurrently with external beam
      radiotherapy (EBRT) 5 days a week for 5.5 weeks. After completion of EBRT and PCI-0120,
      patients may undergo radiotherapy boost for 5 consecutive days. Cohorts of 3-6 patients
      receive escalating doses of PCI-0120 until the maximum tolerated dose (MTD) is determined.
      The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
      dose-limiting toxicity. A total of 6-12 patients are treated at the recommended phase II
      dose. The recommended phase II dose is defined as the dose immediately preceding the MTD.
      Patients are followed at 4 weeks.

      PROJECTED ACCRUAL: A total of 18-21 patients will be accrued for this study.
    

Intervention name(s): motexafin gadolinium; radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Motexafin gadolinium
Primary purpose: Treatment
Keywords: stage II pancreatic cancer; stage III pancreatic cancer; unresectable gallbladder cancer; unresectable extrahepatic bile duct cancer; stage IV pancreatic cancer
An Algorithm for Prognosis of Upper Limb Paresis in Patients With Subacute Stroke
Condition: Stroke; Upper Limb Hypertonia; Physical Activity
MeSH terms: Stroke; Paresis
Study type: Observational

Summary: 
      Aim study 1:Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting.

      Aim study 2: Prediction of real life UL use. Method: A prospective cohort study. Main outcome
      measure study 1: Action Research Arm Test (ARAT), measuring UL motor function.

      Main outcome study 2: use ratio between affected and unaffected UL measured by
      accellerometer.

      Secondary outcome measure: Fugl-Meyer Motor Assessment for UL (FM).
    

Detailed description: 
      Background Accurate prediction of recovery of UL function after stroke can lead to targeted
      rehabilitation. The Predict Recovery Potential (PREP2) algorithm combines individual
      prediction of UL function with recommendations for treatment. The PREP2 algorithm is based on
      clinical assessment of UL paresis combined with transcranial magnetic stimulation (TMS) to
      examine corticospinal tract integrity. For this PhD project the PREP2 is modified to be
      applicable in a rehabilitation setting and the initial assessment of PREP2, the SAFE score,
      is carried out at day 14.

      Study 1 Aim: Assess the accuracy of PREP2 when applied in a subacute rehabilitation setting.

      Hypothesis: PREP2 applied at day 14 post stroke accurately predicts UL function 3 months
      after stroke for a minimum of 75 % of the patients.

      Method: A prospective cohort study. Setting and population: The study will take place at
      Hammel Neurorehabilitation Centre and University Research Clinic. Ninety patients will be
      included.

      Inclusion criteria: First or recurrent ischemic or hemorrhagic stroke (diagnosis verified by
      CT or MR scan); New upper limp impairment; Less than 15 days post stroke; ≥ 18 years; Able to
      follow simple commands and cooperate with examinations Main outcome measure: Action Research
      Arm Test (ARAT), measuring UL motor function.

      Secondary outcome measure: Fugl-Meyer Motor and sensory Assessment for UL. Functional
      Independence Measure (FIM).

      Examined at baseline: Pain wil be assessed with a verbal rating scale. Inferior subluxation
      in the glenohumoral joint. Neglect will be assessed with star cancellation test and line
      bisection test

      Study 2 Prediction of real life UL use Hypothesis: PREP2 can be used to predict real life UL
      use 3 months post stroke. Patients: The entire cohort from study 1 will be included. Real
      life use will be assessed with accelerometers at 3 months follow up.

      Main outcome: is the use ratio between affected and unaffected UL.
    

Intervention name(s): rehabilitation
Intervention type(s): Other
Intervention description(s): rehabilitation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with stroke in a rehabilitation setting
Identification of Biomarkers Sensitive to Disease Progression in Patients With Mild Cognitive Impairment
Condition: MILD COGNITIVE IMPAIRMENT
MeSH terms: Hypersensitivity; Disease Progression; Cognitive Dysfunction
Study type: Interventional

Summary: 
      THE STUDY WILL BE A TWO-PART RESEARCH

      PART A and PART A extended:

        1. To implement a "common" MRI acquisition protocol in multiple centers across Europe
           (Pharma-COG partners).

        2. Apply the common MRI protocol on phantoms and human subjects to characterize, compare
           and minimize test-retest variability across the MR sites of WP5 for all the quantitative
           metrics that will be later assessed on patients.

      PART B: By collecting clinical, biochemical, neuroimaging, neuropsychological and
      neurophysiological data in Mild Cognitive Impairment patient, we aim to:

        1. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints)
           which is more sensitive than the changes observed in the loss of hippocampal volume
           (primary endpoint) and correlate with the neuropsychological progression and conversion
           (clinical secondary endpoints).

        2. To develop a biomarker MATRIX (made of a combination of biological secondary endpoints)
           at baseline which is more predictive of the loss of hippocampal volume (primary
           endpoint) and neuropsychological progression (clinical secondary endpoint) in MCI
           patients.

        3. To harmonize the biomarker MATRIX collection and qualify multiple centres across Europe
    


Intervention name(s): Lumbar puncture
Intervention type(s): Procedure
Intervention description(s): All the patients will be divided in two groups based on their Aβ 1-42 levels measured in the cerebro-spinal fluid obtained form a lumbar puncture: in low Aβ1-42 (positive aMCI patients CSFP) and high Aβ1-42 (Negative aMCI patients CSFN). The threshold of Aβ1-42 used to divide the patient will be 500 (ng/L) based on Sjogren criteria (2001).
Timeframe of lumbar punctures: every 18 months during 2 years (T0 and T18) or 3 years (T0, T18 and T36).
Other intervention name(s): Cerebrospinal fluid puncture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MEMORY and COGNITIVE IMPAIRMENT; ALZHEIMER DISEASE CONVERSION; Amyloid beta-Peptides
Predisposing Factors for Chronic Postherniotomy Pain
Condition: Chronic Postherniotomy Pain
Study type: Interventional

Summary: 
      Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair.
      However no prospective study has investigated potential predisposing factors for development
      of pain, including genetic, psychosocial and detailed neurophysiological assessment of
      surgical method.

      The current study will assess the above factors in a prospective study.
    


Intervention name(s): Open sutured mesh repair; Laparoscopic mesh glue fixation
Intervention type(s): Procedure; Procedure
Intervention description(s): Open sutured mesh repair; Laparoscopic mesh glue fixation
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Groin hernia; Chronic postsurgical pain; open mesh repair; laparoscopic mesh glue fixation; Sensory changes after groin hernia repair
Assess the Oral Bioavailability of a New ABT-263 Formulation in Healthy Female Subjects
Condition: Healthy Female Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, open-label, single center, three period crossover study to
      determine the oral bioavailability of a new ABT-263 formulation relative to that of the
      current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately
      12 healthy female subjects will be enrolled in this study.
    

Detailed description: 
      This is a Phase 1, randomized, open-label, single center, three period crossover study to
      determine the oral bioavailability of a new ABT-263 formulation relative to that of the
      current ABT-263 formulation being administered in ongoing Phase 1/2a studies. Approximately
      12 healthy female subjects will be enrolled in this study.
    

Intervention name(s): ABT-263; ABT-263; ABT-263
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Period 1: Single (oral) dose of 25 mg of Formulation A Period 2: Single (oral) dose of 25 mg of Formulation B1 Period 3: Single (oral) dose of 25 mg of Formulation B2; Period 1: Single (oral) dose of 25 mg of Formulation B1 Period 2: Single (oral) dose of 25 mg of Formulation B2 Period 3: Single (oral) dose of 25 mg of Formulation A; Period 1: Single (oral) dose of 25 mg of Formulation B2 Period 2: Single (oral) dose of 25 mg of Formulation A Period 3: Single (oral) dose of 25 mg of Formulation B1
Intervention MeSH terms: Navitoclax
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
A Study to Assess the Efficacy and Safety of OBE2109 in Subjects With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the efficacy and safety of a range of oral
      doses of OBE2109 versus placebo, in reducing endometriosis associated pain.
    

Detailed description: 
      The study is a prospective, dose-finding, randomized, parallel group, double-blind,
      placebo-controlled phase 2b study investigating the efficacy and safety of OBE2109 in the
      treatment of 330 women with moderate-to-severe endometriosis associated pain.

      Subject will be randomized to one of 6 treatment groups in a 1:1:1:1:1:1 ratio (1 placebo
      group, 5 dose groups with different dosage/regimen).

      Eligible subjects will be offered the opportunity to continue treatment with OBE2109 in an
      extension phase. Subjects who do not continue in the extension will enter the treatment-free
      follow-up phase of the study.
    

Intervention name(s): Placebo; OBE2109
Intervention type(s): Drug; Drug
Intervention description(s): Placebo tablets for oral administration once daily; OBE2109 tablets for oral administration once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pelvic Pain; Endometriosis; Dysmenorrhea; Dyspareunia
A Study of MORAb-009 in Patients With Solid Tumor
Condition: Cancer; Mesothelin-positive
Study type: Interventional
Phase: Phase 1

Summary: 
      MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks
      as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated
      dose.
    


Intervention name(s): MORAb-009
Intervention type(s): Drug
Intervention description(s): MORAb-009 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Mesothelin-positive
Wildlife and Wellbeing: An Animal-Assisted Intervention for Veterans With PTSD
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      This study investigates a novel approach to animal-assisted interventions through a series of
      wildlife immersion activities (wildlife observation, wildlife rehabilitation and bird
      feeding/watching) for veterans who have suffered trauma as part of their military duty.
      Findings from this study will advance scientific knowledge about the benefits of wildlife
      activities for veterans with PTSD including the acceptability, feasibility, safety and
      preliminary influence on physical and mental well-being. The findings will be instrumental in
      advancing a new area of health intervention research for veterans in settings that are
      publicly accessible and family-oriented for sustainable, low-cost interventions with
      potential application in other populations.
    

Detailed description: 
      This study utilized a crossover design. The intervention included an introductory forest walk
      followed by 3 wildlife immersion activity experiences in different settings that offered
      different ways to experience wildlife. This included an introductory forest walk, a wildlife
      rehabilitation center, a wildlife sanctuary and a bird watching program. Each activity was
      conducted twice to minimize potential anxiety and novelty effects. Activities were conducted
      in small groups to provide peer support.
    

Intervention name(s): Forest walk; Wildlife rehabilitation; Wildlife sanctuary observation; Bird feeding and watching
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will be provided with an educational program about the forest and take a guided forest walk.; Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.; Participants will be provided an educational program on wildlife care and accompany park game keepers during animal feeding and will observe iconic wildlife.; Participants will learn about bird identification and safe bird feeding. Bird feeders will be provided at the Soldier On facility for home bird feeding after study conclusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Economic Evaluation of Heart Failure Management in Colombian Clinics
Condition: Heart Failure; Asthma
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Cost effectiveness analysis of local management of patients diagnosed with heart failure
      disease compared with an ideal guideline-based management.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Moderate to severe uncontrolled asthma.
      
Keywords: Cost-effectiveness analysis; Colombia
Effect of Virtual Reality Glasses as a Distraction Method on Child's Anxiety During Dental Treatment
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of the study is to evaluate and compare the effect of virtual reality glasses (VR) to
      conventional behavior management techniques as a distraction method on child's dental anxiety
      during dental treatment
    

Detailed description: 
      The study to be conducted will be a randomized controlled clinical trial .The sample will
      consist of forty children presented to the Department of Pediatric Dentistry and Dental
      Public Health, 20 preschoolers of age ranging from 4-5 years old and 20 schoolers of age
      ranging from 6-8 years old. The eligible participants will be randomly divided into a study
      group where virtual reality glasses distraction will be used for child behavior management
      and a control group where conventional behavior management techniques (tell-show-do,
      distraction, and positive reinforcement) will be used.
    

Intervention name(s): Virtual Reality (VR); Conventional Behavior Management Techniques
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All the dental procedures that will be done will be explained to the child using tell-show-do technique. VR glasses will be introduced to the child using tell-show-do technique and he will be given a choice of cartoon episodes to select from according to his own interest and age appropriate to view during the dental treatment. The child will be given five minutes to get familiar with the VR glasses before starting the dental treatment.; Conventional behavior management techniques will be done to relieve the child's dental anxiety during the dental treatment such as : tell-show-do technique, distraction, and positive reinforcement, according to the child's behavior.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The eligible participants will be randomly and equally divided into group I (study) and group II (control). Each group will be further subdivided according to age into subgroup A (preschool aged children) and subgroup B (school aged children).
Masking: None (Open Label)
Primary purpose: Other
Keywords: virtual reality; distraction; salivary cortisol