cyrilzakka/clinical-trials huggingface dataset:
MTOR Inhibitors in Older Adults

Over the past decades, healthcare systems face significant challenges to meet the needs of an aging population due to progressive debility, functional decline and chronic diseases development. While there is a growing appreciation of the potential impact of mTOR inhibitors on slowing aging processes, preventing chronic disease and prolonging healthy lifespan, a major challenge in developing clinical trials to establish the clinical efficacy of mTOR inhibitors is the absence of pharmacokinetics (PK) and pharmacodynamics (PD) data in older adults. The proposed study will provide the foundation for future clinical trials assessing the role of mTOR inhibitors on aging related indications

Study Objectives To characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of mTOR Inhibitors and determine whether mTOR Inhibitors will improve phenotypic biomarkers of aging as measured by SASP (senescence-associated secretory phenotype) index score at 3 months follow-up in older adults.

Specific Aims:

Aim 1: To characterize Pharmacokinetics (PK) and Pharmacodynamics (PD) of mTOR Inhibitors (sirolimus and everolimus) in older adults.

Aim 2: To determine whether mTOR Inhibitors will improve phenotypic biomarkers of aging as measured by SASP (senescence-associated secretory phenotype) index score at 3 months follow-up.

Exploratory Aim 3: We will also assess the feasibility of collecting the laboratory biomarkers (ESR, CRP, S6K activity, mitochondrial function, metabolomics) and data regarding the functional biomarkers of aging measured by walking speed, chair stand, standing balance, grip strength

Eligibility Criteria:
Inclusion Criteria:

1. Community-dwelling adults
2. Patients should be 65 Years and older
3. Patients is able to understand and follow trial procedures

Exclusion Criteria:

1. Creatinine clearance \<30 mL/min;
2. History of chronic liver disease;
3. Uncontrolled Hypertension (i.e., systolic blood pressure \>160 mm Hg);
4. Hemorrhagic central nervous system (CNS) event within 1 year from screening visit;
5. Thrombotic event (DVT,PE) within 1 year from screening visit if not on anticoagulation;
6. Planned major surgical procedures;
7. Cardiovascular diseases ( i.e., admission for heart failure or myocardial infarction within 12 months);
8. Taking medication that increase or decrease sirolimus blood concentrations;
9. Other investigational therapy received within 1 month prior to screening visit;
10. History of dementia; 11 Dependence in any Katz Basic Activities of Daily Living.
Safety and Efficacy of Isatuximab in Lymphoblastic Leukemia

Primary Objective:

To evaluate the efficacy of isatuximab.

Secondary Objectives:

* To evaluate the safety profile of isatuximab.
* To evaluate the duration of response (DOR).
* To evaluate progression free survival (PFS) and overall survival (OS).
* To evaluate the pharmacokinetics (PK) of isatuximab in participants with T-ALL or T-LBL.
* To evaluate immunogenicity of isatuximab in participants with T-ALL or T-LBL.
* To assess minimal residual disease (MRD) and correlate it with clinical outcome.

The study duration per participant included a 3-week screening period, an approximately 1 year of treatment period or until disease progression or discontinuation for any other reason, and a follow-up period of at least 30 days after the last investigational medicinal product administration.

Eligibility Criteria:
Inclusion criteria :

* Participants must had a known diagnosis of acute lymphoblastic leukemia (ALL) of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy.
* Participants must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Participants in first relapse were be eligible regardless of the first remission duration.
* Participants must had been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue).
* No more than 3 prior salvage therapies.

Exclusion criteria:

* Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration.
* Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration.
* Clinical evidence of active central nervous system (CNS) leukemia.
* T-ALL with testicular involvement alone.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
A Family-centered Teaching Model in Pediatric Occupational Therapy Internship

Most of the occupational therapy students received the knowledge of family-centered services when they studies in universities, however, the experience of family-centered practice during internships is limited. The purpose is to design a family-centered teaching model and to examine the effects of the teaching model. The positive results showed on students' perceptions and children's occupational performance.

The study examined the differences of interns' perceptions of services toward family-centeredness and children' occupational performance between a family-centered teaching (FACT) model and a conventional family approach incorporated in internships. A two-group quasi-experimental design was employed. Participants included 49 interns, 44 caregivers, and 45 children with disabilities under six-year-old. The perceptions of interns toward FCS in both groups were measured using the Chinese version of the "Measure of Processes of Care-Service Provider" (C-MPOC-SP) at the pre- and post- tests. Children' occupational performance in both groups was rated using the "Canadian Occupational Performance Measure" (COPM) for the pre- and post-tests. Interns in the experimental group demonstrated a significant increase in two of the four C-MPOC-SP subscales compared to their counterparts. Children' scores improved significantly in COPM performance subtest for experimental group, but not on the COPM satisfaction subscale.

Eligibility Criteria:
Inclusion Criteria:

1. Children with developmental delays/disabilities and their caregivers
2. Children with developmental delays/disabilities under six years old
3. The caregivers of the children with disabilities are aged 20 years old or older
4. The caregivers of the children with disabilities or delays can follow the instruction to administer the assessment
5. Students are participating in internships of the pediatric occupational therapy clinical unit at the hospitals.

Exclusion Criteria:

* Caregiver suffered from mental illness and had difficulty to complet the study.
Pelvic Floor Muscles Training Associated Dry Needling for Chronic Pelvic Pain

The presence of trigger points in the pelvic floor musculature (PFM) is a frequent condition in individuals with chronic pelvic pain (CPP) and is associated with higher levels of pain, disability and functional decline. The purpose of this study is to test the effectiveness of two interventions: pelvic floor muscle (PFM) training with biofeedback and PFM training with the addition of trigger point dry needling applied over(Lumbar square, psoas, external obliques, gluteus medius, piriformis and adductors) on pain and quality of life of women with CPP.

Chronic pelvic pain (CPP) is characterized as non-cyclic pain located in the distal region of the abdomen and pelvis, often refractory to conventional treatments, lasting more than six months The presence of trigger points in the pelvic floor muscles (PFM) is a frequent condition in individuals with CPP and is associated with higher levels of pain, disability and functional decline. Secondary dysfunctions associated with the clinical picture of chronic pelvic pain can be treated with muscle training through the use of biofeedback and dry needling. The purpose of this study is to test the effectiveness of two interventions: pelvic floor muscle (PFM) training with biofeedback and PFM training with the addition of trigger point dry needling applied over(Lumbar square, psoas, external obliques, gluteus medius, piriformis and adductors) on pain and quality of life of women with CPP.

We will recruit 44 women aged 18 to 60 years with CPP lasting for a minimum of six months. We will exclude women with urinary incontinence, neurological conditions, malignancy, fractures, pregnancy and those that did not agree to receive treatment with needles will be excluded.

Individuals will be randomized into two groups: PFM training with biofeedback and Dry Needling Group and PFM training with biofeedback. Participants will receive a total of 4 sessions twice a week,,for two weeks. This investigation's primary outcome will be pain (NRS) Immediately after the 4 visits. Quality of life, global impression of recovery and sexual function evaluated at Immediately after the 4 visits will be secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Women
* Aged between 18 and 60 years
* Pain in the lower pelvic and lumbar region, are not related to filling or emptying of the bladder, for more than 6 months
* With medical diagnosis of CPP

Exclusion Criteria:

* Previous spinal surgery
* Any neurological condition
* Cancer,
* Fractures in the pelvic region and or lumbar spine
* Lumbar radiculopathy.
* Pregnancy
* Women with difficulty in understanding written or spoken language
* Having urinary infection or appendicitis on the day of evaluation,
* Who are diagnosed with Post-coital bleeding, postmenopausal bleeding, unexplained abrupt weight loss, presence of visible mass on ultrasound, macroscopic or microscopic hematuria.
* Performed some surgical intervention with general anesthesia in the last 120 days,
* Having being received Intervesical therapy or botox in the last 90 days,
* Aversion / phobia to needles .
Bendamustine and Mitoxantrone in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

RATIONALE: Drugs used in chemotherapy, such as bendamustine and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bendamustine together with mitoxantrone works in treating patients with relapsed or refractory B-cell chronic lymphocytic leukemia.

OBJECTIVES:

Primary

* Determine the response rate (remission rate) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with bendamustine and mitoxantrone hydrochloride.

Secondary

* Determine the progression-free survival and overall survival of patients treated with this regimen.
* Determine the safety and tolerability of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive bendamustine IV over 1 hour on days1-3 and mitoxantrone hydrochloride IV over 30 minutes on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease (i.e., complete response or partial response) after 2 courses receive 2 additional courses of treatment for a total of 4 courses.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Cytologically and immunophenotypically confirmed diagnosis of B-cell chronic lymphocytic leukemia (CLL)

  * Relapsed or refractory disease

PATIENT CHARACTERISTICS:

* No known hypersensitivity to any of the study medications
* No uncontrolled infection
* No impaired organ function

PRIOR CONCURRENT THERAPY:

* Not specified
Intraoperative Berger Space Imaging (IBSI)

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery.

The laser will be reduced to image the Berger space. If not visible, the space will be enhanced with BSS and Volon A to visualize the BS.

Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date.

Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination and retinal oct imaging.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
* Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible)
* Preoperative pupil size in mydriasis ≥ 6.0 mm

Exclusion Criteria:

* Preceding ocular surgery or trauma
* Pseudoexfoliation
* Recurrent intraocular inflammation of unknown etiology
* Uncontrolled glaucoma
* Uncontrolled systemic or ocular disease
* Blind fellow eye
* Microphthalmus
* Corneal abnormality
* History of uveitis/iritis
* Iris neovascularization
* Proliferative diabetic retinopathy
* Macular degeneration or any other relevant macular diseases
* Pregnancy
Superior Trunk Block Catheter Versus Single-shot Superior Trunk Block With Intravenous Dexmedetomidine for Shoulder Arthroplasty

Shoulder arthroplasty is associated with significant postoperative pain. Appropriate pain control after shoulder arthroplasty is crucial for postoperative rehabilitation and patient satisfaction. Superior trunk block is a commonly employed regional anesthetic technique for shouler arthroplasty, and a continuous catheter is often placed to extend the analgesic benefit of the block. However, continuous peripheral nervel block (PNB) is more costly and time-consuming than sigle-shot PNB. Recent evidence suggests that intravenous (IV) dexmedetomidine (DEX) prolong the analgesic duration after sigle-shot PNB. The investigators will compare continuous superior trunk block with single-shot superior trunk block with IV DEX in patients undergoing shoulder arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1 Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective shoulder arthroplasty

Exclusion Criteria:

1. Allergy or intolerance to any of the drugs used in the study
2. Heart failure
3. Hepatic or renal insufficiency
4. Opioid dependency
5. Coagulopathy
6. Pre-existing neurologic or anatomic deficits in the upper extremities
7. Severe psychiatric illness
Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)

This study will assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Participant is scheduled to undergo cardiothoracic surgery involving a full median sternotomy (not including cardiac transplantation surgery) within 14 to 60 days after vaccination.
* Female participants of reproductive potential are required to have a negative urine or serum pregnancy test immediately prior to study vaccination and must use an acceptable form of birth control.

Exclusion Criteria:

* Participants had an invasive Staphylococcus aureus infection within the past 3 months prior to study entry.
* A realistic (\>50%) possibility that cardiothoracic surgery will be necessary sooner than 10 days after vaccination.
* Participant is planning to undergo cardiac transplantation surgery or sternal debridement to remedy an infection resulting from a prior cardiothoracic surgery.
* Participant has any type of ventricular-assist device in place at the time of study entry.
* Participant has a history of anaphylaxis to any of the vaccine components.
* Participant received V710 vaccine, any other investigational Staphylococcus aureus vaccine, or investigational Staphylococcus aureus antibodies.
* Participant has a temperature of ≥100.4ºF (≥38.0ºC), oral equivalent, within 48 hours prior to study vaccination.
* Participant has impairment of the immune system.
* Participant has a medical condition in which the expected survival is less than 90 days.
Pilot Study of Diet and Behavior in Children With Autism

We hypothesize that in children with autism dietary antigens can change the intestine, making it "leaky" and then affecting the brain changing their behavior.

Subjects in 2 different diets (gluten/dairy and placebo) will be monitored for changes in intestinal permeability (urine lactulose mannitol ratio) and behavior (psychometric testing).

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 3 and 12 years,
* DSM-IV (APA, 2000) diagnosis of Autistic Disorder (DSM-IV 299.90),
* willingness to follow and maintain a gluten-free-dairy-free-diet for 4 weeks.

Exclusion Criteria:

* food allergies,
* celiac disease,
* inflammatory bowel disease,
* infectious gastrointestinal,
* seizure disorder,
* neurological problems with behavioral changes,
* unwillingness to undertake the dietary challenge with milk and gluten or to maintain a gluten-free-dairy-free-diet during the study were excluded
Post Market Surveillance Study of the Wingspan Stent System

The primary objective of this study is to evaluate the rate of stroke and/or death in patients treated with the Wingspan Stent System, according to the Indications for Use, within 72 hours post procedure.

This research study is a Food and Drug Administration (FDA) mandated post market surveillance study of the Wingspan® Stent System, also known as the WEAVE™ Trial. The purpose of this trial is to fulfill a FDA requirement to evaluate the rate of stroke and/or death within 72 hours of the procedure, in patients who have a Wingspan Stent implanted in accordance with the Indications for Use.

Eligibility Criteria:
All patients for whom treatment with the Wingspan Stent System is considered.
The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

The purpose of this study is to further evaluate the safety and effectiveness of the Harmony™ TPV system. The Pivotal/CAS phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the Medtronic Harmony TPV.

The continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the Harmony TPV system. All implanted subjects will receive the Harmony TPV 22 or Harmony mTPV 25 device. This phase allows up to 45 subjects implanted with TPV 22 in the United States and Canada, and up to 84 subjects implanted with mTPV 25 in the United States.

The Post Approval Phase (PAS) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the Harmony TPV system in the United States. All implanted subjects have been implanted with the Harmony TPV 22 or Harmony mTPV 25 device during the pivotal or CAS phase of the study. The PAS addendum extends follow-up from five years to ten years for consenting subjects.

Eligibility Criteria:
Inclusion Criteria:

* Subject has severe pulmonary regurgitation as assessed via echocardiography or CMR determined PR fraction \>/= 30%
* Subject has clinical indication for surgical placement of an RV-PA conduit or bioprosthetic pulmonary valve
* Subject is willing to consent to participate

Exclusion Criteria:

* Patients with right ventricular outflow tract obstruction (RVOTO) lesions surgically treated with an RV-to-PA conduit implant
* RVOT anatomy or morphology that is unfavorable for device anchoring
* Positive pregnancy test
* Life expectancy of less than 1 year
Outcomes From Remediation and Behavioural Intervention Techniques

It is currently unknown what factors predict response to Cognitive Behavioural Therapy for Psychosis (CBTp) or Cognitive Remediation Therapy (CR) among individuals with schizophrenia-spectrum disorders, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy.

Dominant treatment approaches for schizophrenia-spectrum disorders improve psychiatric symptoms but do little to improve community functioning, leading to persistent disability and substantial economic burden. The proposed trial aims to examine the efficacy of a multi-mechanism approach to combining CBT and CR with the goal of predicting treatment response to either monotherapy or combination therapy. To date, there have been no randomized controlled trials examining the combination of CBT and CR. Given the differential mechanisms of CBT and CR, the combined multi-mechanism approach is expected to more effectively improve functional recovery than either monotherapy. Additionally, it is currently unknown what factors predict response to CBT or CR, thus the current trial will examine predictors of response to determine who requires the combined intervention and who might respond sufficiently to either monotherapy. The proposed trial will be one of the largest trials of psychosocial interventions for schizophrenia-spectrum disorders ever conducted and will simultaneously evaluate the combined intervention and moderators of differential treatment response. Narrower fields of inquiry examining mono-mechanism interventions have demonstrated little utility in improving functional recovery in schizophrenia, thus, the proposed approach represents a critical advancement by examining the utility of a multi-mechanism cognitive intervention and determining characteristics of those requiring this level of treatment.

The goals of the current study are three-fold:

1. Examine the efficacy of combining CBT and CR on the primary outcome of community functioning, and secondary outcomes of quality of life, personal recovery, psychiatric symptoms, and neurocognition compared to either intervention alone.
2. Examine demographic, cognitive, and psychological factors that predict differential response to CBT, CR, or combined CBT and CR.
3. Examine the specificity of cognitive content and cognitive functions as therapeutic mechanisms in CBT and CR respectively.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-65 years
* Diagnosed with schizophrenia-spectrum disorders
* Can read, write, and speak English

Exclusion Criteria:

* Neurodevelopmental disability or neurocognitive disorder
* CBT or CR in the past 6 months