cyrilzakka/clinical-trials huggingface dataset:
Investigational Study of Psychological Intervention in Recipients of Lung Transplant (INSPIRE)

The purpose of this study is to examine the effectiveness of a telephone-based cognitive behavioral therapy intervention to alleviate psychological distress among lung transplant patients.

BACKGROUND:

Lung transplantation is a relatively new procedure developed to increase life expectancy in selected individuals with irreversible end-stage lung disease. In the brief period since its inception, it appears that lung transplantation has achieved its initial aim of extending life. Despite these successes, lung transplantation remains fraught with difficult challenges for the patient and the medical community. The pre-surgical waiting period is a particularly stressful time. The long, uncertain wait for an organ, the marked decline in functional capacity, the tremendous financial burden, and the prospect of a complicated medical regimen after surgery, combine to exert a profound strain on patients' coping capacities. Not surprisingly, the rate of clinically significant psychological distress during this period is quite high, with rates of clinical depression, panic, anxiety and adjustment disorders far exceeding those observed in the general population. Although it is well established that brief, focused cognitive-behavioral therapy (CBT) can significantly improve psychological function in medically ill persons, the wide geographic distribution of transplant patients, along with their marked debilitation makes face-to-face delivery of such therapy extremely difficult. Recent pilot data have demonstrated the feasibility and short-term efficacy of a telephone-based psychological intervention with patients awaiting transplant.

DESIGN NARRATIVE:

INSPIRE was a collaborative study between Duke University Medical Center and Washington University Medical School. Participants first completed a baseline evaluation, including an interview with a staff member, tests of memory and concentration, and a questionnaire packet. They were then randomly assigned (by chance) to one of 2 groups: Stress Management (by phone) or Usual Care. Stress management participants received a phone call from an INSPIRE interventionist every week for 12 weeks; the phone sessions focused on helping to reduce stress and learning new skills to better cope with lung disease and the upcoming transplant. The INSPIRE staff interventionists were all psychologists who had been trained to work with patients with lung disease. Usual care participants continued their routine and usual treatments and did not receive the 12 telephone training sessions. Participants completed follow-up evaluations three months after the initial (baseline) evaluation, after transplant surgery, and twelve months after the initial evaluation. The primary outcome measures were measures of health-related quality of life, general psychological well-being, and social support.

Eligibility Criteria:
Inclusion Criteria:

* Potential lung-transplant candidates listed for lung transplantation at Duke University Medical Center or Washington University
Evaluation of Epalrestat in Metastatic Triple-negative Breast Cancer

To evaluate the efficacy and safety of Epalrestat in the treatment of metastatic triple negative breast

This is a phase II,single center,prospective, single arm clinical trials. The objective is to evaluate the efficacy and safetyof Epalrestat in the treatment of metastatic triple negative breast.Primary endpoint is 16-week clinical benefit rate (CBR).

Eligibility Criteria:
Inclusion Criteria:

* Female ≥ 18 years, ≤70 years.
* Minimum life expectancy 16 weeks
* Histologicalconfirmation of hormone receptor negative and HER2 negative breast cancer(IHC:ER -, PR-) on primary tumour at diagnosis/on biopsy of metastasis
* Clinical or histological confirmation of metastatic or locally advanced disease not amenable to curative surgical resection
* ECOG 0-2 with no deterioration over previous 2 weeks Measurable disease
* Adequate bone marrow and organ function
* Availability of archival tumour sample or fresh biopsy Informed consent
* Normal organ function

Exclusion Criteria:

* Last dose chemotherapy, immunotherapy targeted therapy, biological therapy or tumour embolisation \<21 days prior to study treatment
* Last dose of palliative radiotherapy \<7 days prior to study treatment
* Rapidly progressive visceral disease not suitable for further therapy
* Spinal cord compression or brain/meningeal metastases unless asymptomatic, treated and stable and not requiring steroids for ≥ 4 weeks study treatment
* Major surgery (excluding placement of vascular access) within 4 weeks before study treatment
* Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV
* With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
* Elevated ALP in absence of bone metastasis
* Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
* Participation in another study with investigational product during last 30 days
* Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
The Prevention of Postoperative Epidural Catheter Migration: a Comparison of Three Types of Dressing

Three types of dressing will be compared to prevent postoperative epidural catheter migration. Patients will be randomised to have a Tegaderm dressing, an Epi-fix dressing or a Lockit-Plus dressing to secure the epidural catheter for postoperative analgesia. The length of the epidural catheter visible at the patient's skin surface will be recorded after insertion and every day until removal. The integrity of the dressing and problems with analgesia will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

* All patients who receive a lumbar epidural catheter for patient controlled analgesia will be included after informed consent
* 18 years or older

Exclusion Criteria:

* Patients who did not sign an informed consent
Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.

The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 years or older - Complicated skin and skin structure infection (cSSTI) - Infection of sufficient severity to warrant hospitalization - Infection of sufficient severity such that it is expected to require at least 5 days of intravenous antibiotic therapy. patients must have a positive culture for MRSA that has been obtained from the skin infection site and/or blood samples at any time within the 72hrs before the first dose.

Exclusion Criteria:

* Received systemic antibacterial drugs for greater than 24 hours within 96 hours prior to first dose of study drug - Uncomplicated skin and skin structure infections, skin infections suspected to be caused by viral or fungal pathogens - Diabetic foot infections, decubitus ulcers, ulcers due to peripheral vascular disease - Infection caused by human or animal bites, sternal wound infections, bone infection or arthritis due to an infection, critical limb ischemia of the affected limb - Chronic liver disease or severe impaired renal function, severe low white blood cell count, burns on greater than 15% of total body surface area, necrotizing skin infection, amputation required of primary site of infection, sustained shock
Genotype Influence on Recovery After Traumatic Brain Injury

Genetic differences in response to brain injury may reasonably be expected to play a role in the initial consequences of traumatic brain injury and in the rate of recovery from such injury.

Polymorphisms in the Apolipoprotein E gene encode functional variants which differentially determine the rate at which neuronal repair can occur, and are associated with differences in expression of neurodegenerative processes, including traumatic brain injury. It is proposed that the accuracy of prediction of outcome after head injury will be significantly increased by inclusion of APOE genotype alone, or in combination with other variables such as severity of head injury, cognitive, electroencephalographic or neuroradiologic measures, or treatment strategies.

Eligibility Criteria:
Patients enrolled in the DVHIP are subject to the following recruitment criteria:

1. Mild, moderate or severe closed head injury, where the cut off between mild and moderate is defined by GCS\<12. PTA\>24 hrs or - foca cerebral contusion on CT/MRI or Loss of Consciousness (LOC) \> 12 hours.

   Note: the definition of mild, moderate or severe head injury differs widely between centers and is absolutely not critical for the work proposed as we will use continuous measures of severity throughout.
2. Within three months of first assessment. (In practice, patients may be recruited after 3 months. We will deal with this issue by covarying the time from injury to first assessment in our analyses).
3. Rancho Los Amigos cognitive level of 5-7 at first assessment.
4. Volunteer informed consent signed by patient of family.
5. Military or veterans health care beneficiary.
6. Age 17-55

Exclusion Criteria:

1. Unwillingness to participate in rehabilitation program or cooperate with investigators.
2. History of prior severe traumatic brain injury of other severe neurologic or psychiatric condition, such as psychosis, stroke, multiple sclerosis, or spinal cord injury.
Advanced Diffusion MRI to Differentiate Tumor Recurrence From Pseudoprogression in Patients With Glioblastoma and Brain Metastases

This pilot study investigates whether advanced diffusion-weighted MRI (ADW-MRI) can differentiate between true tumor progression (TP) and a pseudoprogression (PsP) in patients with glioblastoma (GBM) or brain metastases.

Advanced diffusion-weighted MRI (ADW-MRI) offer the opportunity of higher sensitivity towards subtle tissue changes associated with increased specificity relating to damage of different tissue components of the central nervous system (CNS). Within the framework of this study, conventional follow up MRI will be complemented by ADW-MRI in case of suspected tumor recurrence and possible surgical resection of the suspicious tissue. In the case of surgical resection, the histopathological findings will be correlated to the findings of the ADW-MRI. In the depicted pilot phase, the feasibility of the described protocol will be examined and the data concerning correlations between standard histopathologic and genetic workup of the resected tissue and the results concerning tissue features from ADW-MRI will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathologically proven glioblastoma or brain metastasis and suspected tumor progress on standard MRI after first line therapy and who are candidates for elective surgical resection.
* Able to give informed consent

Exclusion Criteria:

* Contraindications to MRI (e.g. claustrophobia, pacemaker or other implants without MRI-approval, pregnancy)
* Patients in a life-threatening condition
* Patients in need of emergent surgery
* Histopathological analyses of insufficient quality
* Unable to give informed consent
* Age \<18 Years
The Effect of LSVT LOUD for Mandarin-speaking Individuals With Hypokinetic Dysarthria Due to Parkinson's Disease

A handful of studies have examined the effects of the Lee Silverman Voice Treatment (LSVT) LOUD on hypokinetic dysarthria in English speakers with Parkinson's disease (PD). Although LSVT LOUD has been found to be effective on improving these speaker's vocal intensity and increasing their speech intelligibility as well as speech function with Phase I evidence, no study has investigated whether Mandarin-speaking individuals with dysarthria secondary to PD would benefit from LSVT LOUD. In the proposed study, speech data of Mandarin-speaking individuals with hypokinetic dysarthria before and after speech therapy will be audio recorded and analyzed in order to examine the effects of LSVT LOUD on the speech function in this population. The same speech data will be played to Mandarin listeners in order to investigate the speech intelligibility of this population. It is hypothesized that Mandarin-speaking individuals with hypokinetic dysarthria secondary to PD will demonstrate reduced vocal intensity, reduced speech intelligibility and impaired speech function before they receive LSVT LOUD. They will improve these speech characteristics following speech therapy and will present with short-term maintenance effects.


Eligibility Criteria:
Inclusion Criteria:

1. Mandarin-speaking Taiwanese
2. Hypokinetic dysarthria due to Parkinson's disease
3. No other neurodegenerative diseases
4. No cognitive deficits
5. Age range 30 years and above

Exclusion Criteria:

1. Not able to follow verbal directions,
2. speech characteristics uncommon to Parkinson's disease
Assessment of Visual Dyslexia Remediation Protocols - Dyslexia REMEDIATION

Dyslexia is first described as a phonological deficit. Several studies report a neurovisual deficit in dyslexics. Some dyslexics have a visual deficit without phonological impairment, others have a pure phonological deficit, and still others have both types of deficits. From this observation the idea emerged to propose specific remediation protocols for people with visual impairments and to assess their effects on reading. At the theoretical level, if visual stimulation is able to improve reading performance, it is the demonstration of the existence of visual origin of dyslexia. At the clinical level, such a result not only opens the prospect of a different and more adapted rehabilitation for these types of dyslexia, but also the prospect, if the visual deficits are pre-existing to the learning of reading, to use them for early diagnosis and management.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 8 to 12
* Diagnosed dyslexics
* Normal or corrected to normal vision
* Legal guardians of children subjects providing their free, informed and written consent to participate in the study; With the child also giving orally his consent to participate.

Exclusion Criteria:

* other neurodevelopmental problem
* strabismus, amblyopia

For the glasses (group 2) : epileptic child are excluded
Low Back Pain and Depression: Cohort Study

The aims of this study are to investigate whether pelvic pain and low back pain disability are associated with postpartum depression and to compare the prevalence between women without Low back pain and disability and women with Low Back Pain (LBP) and disability every trimester, and correlate postpartum Depression and some clinical and biopsychosocial variables: subgroups of LBP, disability, pain intensity, pain widespread and nationality, in a cohort of Spanish women at 2 months postpartum.

295 pregnant women will formed the cohort, during all pregnancy and two months after delivery. The Edinburgh Postnatal Depression Scale was used to evaluate depressive symptoms at 2 months postpartum. The LBP will be evaluated based on self-administrated questionnaire, and the patients with LBP will be classified in to lumbopelvic groups according to mechanical assessment of the lumbar spine, pelvic pain provocation tests, standard history, pain intensity on visual analogue scale, spread of pain through pain drawings and Oswestry index was used to evaluated the disability. Logistics regression analysis will performed to explain the predictors of depression.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were being pregnant between for 12 weeks to 16 weeks,
* With an expected normal pregnancy (as determined by midwife),
* Being able to understand and read Spanish.

Exclusion Criteria:

* Exclusion criteria were end of pregnancy before gestational weeks 37 (delivery or abortion),
* Serious intellectual impairment,
* Having had a systemic disease (spondylitis, infectious, vascular, metabolic or endocrine related process), rheumatic disease, fibromyalgia, lumbopelvic pain or
* Verified diagnosis of spinal problems in the previous 6 months, or
* A history of fracture, neoplasm or previous spinal, pelvic or femur surgery.
* Another exclusion criterion was a diagnosis of depression or anxiety in the previous year.
Mode Evaluation in Sick Sinus Syndrome Trial (MODEST)

The purpose of this study is to determine the incidence of atrial fibrillation and heart failure in patients with pacemaker therapy with different pacing modes (AAI, DDD, and a novel algorithm to minimize ventricular pacing).

Background: Dual-chamber pacemaker therapy has become the mainstay for treating symptomatic sick sinus syndrome (SSS). This approach aims to results in a physiologic conduction pattern, while protecting against atrioventricular conduction anomalies. Smaller studies and subgroup analyses of larger trials suggest that ventricular stimulation associated with this treatment has adverse effects, especially an increased incidence of atrial fibrillation and heart failure.

Methods: In MODEST, a study on patients with sick sinus syndrome who have an indication for pacing therapy, atrial pacing (AAI) is compared with dual-chamber pacing (DDD) combined with a novel algorithm developed to lower the number of ventricularly paced beats. The study aims to assess the impact of ventricular pacing on the development of atrial arrhythmias and to test the hypothesis that DDD pacing using the algorithm is associated with a higher rate of atrial arrhythmias as atrial pacing. Included will be patients with SSS and no high degree AV node disease except for patients with first-degree AV block ≤300ms. Patients will be followed stratified by their Wenckebach point (≥ 120 bpm versus \< 120 bpm).

Conclusion: MODEST is a large, prospective, randomized, multicenter trial aiming to compare a novel type of dual-chamber pacing approach (that includes an algorithm designed to lower the number of ventricularly paced beats) with pure atrial pacing, assessing the impact on the incidence of atrial arrhythmias in patients with sick sinus syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic sinus bradycardia, Sinusarrest
* Symptomatic SA block
* Bradycardia-Tachycardia-Syndrome
* Binodal diseases

Exclusion Criteria:

* 1st degree AV Block
* 2nd degree AV block
* 3rd degree AV block
* Total right bundle branch block
* Indication for biventricular stimulation
* Inter atrial conduction delays (P-wave \> 150MS)
* Permanent or therapy refractory Atrial Fibrillation
* Heart Failure acc. NYHA III or IV
* Myocardial Infarction less than 6 months before pacemaker implant
* Hypertrophic obstructive cardiomyopathy
* Symptomatic hypo- or hyperthyreosis
* Cardiogenic shock
* Pregnancy
* Lactation period
* Unstable angina pectoris
* Poorly controlled Diabetes mellitus
* Neuromuscular diseases
* Patients under 18 years of age
* Patients involved in other studies
* Reduced expectancy of life due to other diseases
* Patients who cannot attend follow-up visits regularly
Open-label Study of TAK-875

The purpose of this study is to evaluate the safety and efficacy of treatment with TAK-875 in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. The participant is an outpatient.
2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
2. The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.
Rocklatan® Evaluation

The objective of this study is to evaluate the IOP-lowering effect when subjects are switched from various latanoprost-based regimens to Rocklatan. Subjects will stop their IOP-lowering medical therapy regimen and dose with Rocklatan for the duration of the study (12 weeks).

Enrollment will be stratified according to subject's IOP-lowering medical therapy regimen as follows:

* Latanoprost monotherapy (Latanoprost Mono)
* Latanoprost plus 1 additional IOP-lowering agent (Latanoprost +1)
* Latanoprost plus 2 additional IOP-lowering agents (Latanoprost +2)

Aerie Pharmaceuticals was acquired by Alcon Research LLC on November 22, 2022.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female subjects age 18 or older
* Current diagnosis of open-angle glaucoma or ocular hypertension
* Subject currently being treated with latanoprost alone or latanoprost plus 1 or 2 additional agents/bottles. Current IOP lowering regimen is stable for at least 30 days prior to Baseline Visit
* Treated IOP ≥ 20 mmHg measured in the morning (before noon) at the Baseline Visit by Goldmann applanation tonometer
* Best corrected Snellen visual acuity of 20/100 or better in both eyes
* Willingness to follow protocol requirements, including signed informed consent and health information release forms, routine follow-up schedule, completing questionnaires

Key Exclusion Criteria:

* Have any active ocular disease other than open-angle glaucoma or ocular hypertension that would interfere with study interpretation
* Use of fixed dose combination agents as part of the patient's Baseline IOP lowering therapy regimen, if not also on latanoprost
* Active ocular infection/inflammation or history of uveitis
* Aphakic or pseudophakic patients with a torn posterior lens capsule, or with known risk factors for macular edema
* Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results
* Use of topical, periorbital, intravitreal or systemic steroid within previous 3 months or expected use during the course of the study
* Prior participation in any investigational drug or device study within the last 30 days prior to the Baseline Visit.
* Known sensitivity or allergy to the study medication or components
* Females who are pregnant, nursing, or planning a pregnancy during the study
* Positive pregnancy test at Baseline Visit (women of childbearing potential only)
* Women of childbearing potential who are not using a medically acceptable form of birth control