cyrilzakka/clinical-trials huggingface dataset:
Safety Study of DIPG Treatment With Autologous Dendritic Cells Pulsed With Lysated Allegenic Tumor Lines

The purpose of this study is to asses safety of diffuse intrinsic pontine glioma (DIPG) treatment with autologous dendritic cells pulsed with lysated allegenic tumor lines

Evaluate the nonspecific immune response generated in peripheral blood and Cerebral Spinal Fluid (CSF) by proposed treatment Evaluate the specific antitumor immunity response generated in peripheral blood and CSF Assess overall survival and progression free survival Correlate the neuroradiological changes with the clinical course and immune response generated in peripheral blood and CSF Quality of life evaluation


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed DIPG Patients without progressive disease
* Aged between 3 and 18 yo Lansky scale \>50 (Karnofsky for patients aged more than 16 yr)
* Life expectancy \> 8 weeks
* Preserved bone marrow function Normal hepatic and renal function

Exclusion Criteria:

* Impossibility to perform aphaeresis
* Patient participation of other experimental study within the last 3 months
* Patient under antitumor treatment in the last 4 weeks
* Co-morbidity that does not allow the study treatment
* Patients requiring \> 2mg/day of dexamethasone treatment Corticoid-dependent patients
* Patients under uncontrolled infection
* Positive serologies of HIV, hepatitis C virus (HCV) or hepatitis B virus (HBV)
Percutaneous Peritoneal Dialysis Catheter Insertion (PREDICT)

Peritoneal dialysis (PD) is the most frequent modality of home dialysis for patients with kidney failure.

Most PD catheters are placed using a laparoscopic technique. This approach requires the availability of a qualified surgeon, time in the operating theater and general anaesthesia for the patient. Thus, the laparoscopic technique is less suitable for patients with severe heart failure or multimorbidity where general anaesthesia is not possible.

PD catheters can also be inserted using a percutaneous strategy using a modified Seldinger technique. This strategy can be performed bedside under local anaesthesia, by the nephrologist, radiologist, a surgeon, physician assistant or qualified nurse.

The availability of the percutaneous implantation strategy of a PD catheter in a nephrology center may accomodate more patients to receive a PD catheter insertion, including those who have a contraindication to general anaesthesia or need urgent PD.

The PREDICT project aims to increase knowledge and competencies on percutaneous PD catheter insertions by training centers for this technique. By establisching a prospective registry, the outcomes of percutaneously inserted PD catheters, both in experienced and newly trained centers, will be assessed.

The population of the PREDICT study are adult patients requiring a peritoneal dialysis catheter insertion. Decision for percutaneous strategy of catheter insertion (versus surgical catheter insertion) is made by the treating physician.

The inclusion criteria for the prospective PREDICT registry are age \> 18 years and percutaneous PD catheter insertion between 1 March 2023 and 1 March 1 2026 in participating centers.

Patients can be included 4 weeks before until 12 weeks after PD catheter insertion. The exclusion criteria are the inability to give informed consent and a life expectancy of less than 3 months.

Demographic and clinical data will be collected for all included patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Percutaneous PD catheter insertion between March 1st 2023 and March 1st 2026 Patients can be included 4 weeks before until 12 weeks after PD catheter insertion

Exclusion Criteria:

* Inability to provide informed consent
* Life expectancy \< 3 months
Improving Well-Being for Older Adult Family Dementia Caregivers

This study will examine the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well program, compared to a control group, to see if the programs might be associated with better immune function (response to current influenza vaccine), physical and emotional health, and well-being.

A considerable literature documents that a wide variety of psychosocial interventions can lessen the psychological burden of family or spousal dementia caregiving. Some caregiver intervention studies have included measures of self-reported physical health and sleep, and others have focused on improving inflammation in caregivers. The current study will add to this literature by examining the effects of two behavioral interventions on adaptive immune responses, particularly, antibody response to influenza vaccination, in older adult family caregivers.

Eligibility Criteria:
Inclusion Criteria:

* 55 years of age and older
* English-speaking (consent process and assessments will be conducted in English only)
* Currently living with or in proximity to, and the primary caregiver for, a loved one with dementia who lives in the community-for the purposes of this study, "loved one" refers to a family member such as a spouse, ex-spouse, significant other, sibling, in-law, parent, or other type of close established relationship (e.g., close friend) regarded as family; "primary caregivers" provide daily informal (non-paid) in-person care.
* Currently experiencing moderate to high levels of perceived stress (PSS-10 ≥ 12) and/or caregiver burden (MCSI ≥ 5)
* Participants will be asked to stabilize medications prior to beginning the trial, and for the duration of the trial (If medication dose changes do occur, analytic models will include those changes as time-varying covariates)

Exclusion Criteria:

* Loved one with dementia currently resides in a long-term care facility (e.g., nursing home) without the caregiver.
* Given the didactic and self-directed nature of the MBSR program, individuals with major, uncorrected sensory impairments and cognitive deficits, as determined by a Montreal Cognitive Assessment (MoCA) score of 23 or lower 29, will be excluded, as will participants with other neuropsychological deficits deemed significant enough to interfere with study participation. Low literacy is not an exclusion criterion; questionnaires will be orally administered when necessary.
* Modules from the Mini International Neuropsychiatric Exam (MINI 30) will be used to exclude subjects who have these psychiatric conditions: current alcohol dependence, current non-alcohol psychoactive substance use dependence, psychotic disorders (current and lifetime), bipolar disorder, and current mood disorder with psychotic features.
* Subjects will also be excluded for the following reasons: having completed an MBSR program in the past; allergy to eggs (the influenza vaccine is most commonly manufactured using an egg-based process); history of Guillain-Barré syndrome; immunodeficiency or receipt of immunosuppressive therapy; recent major surgery; and active neoplastic disease.
Megachannel Device for Advanced Colonoscopy

Megachannel is a newly developed colonic access system allowing rapid and multiple passes of the colonoscope to the right colon.

The investigators want to conduct a multinational study to evaluate the safety and clinical feasibility of placing a 100 cm Megachannel prototype in the right colon.

Patients scheduled for colonoscopy with suspected right colonic polypoid lesions will be included. The prototype will loaded onto a 160 cm lower GI endoscope and introduced via colonoscopic guidance. Time to cecum, total investigation time, clinical feasibility and complications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for colonoscopy with suspected large or multiple polys in the right colon

Exclusion Criteria:

* previous abdominal surgery
* history or currently diagnosed intra-abdominal cancer
* patients presenting with unstable angina
* drug abusers
* pregnant women
* patients with known colonic strictures
Description of Case of Infection With a New Species of Babesia and Its Molecular Diagnosis

Babesiosis is a potentially very serious infection, but too little known. investigators want to raise their clinical colleagues and remind fellow biologists of the importance of choosing a good molecular diagnosis so as not to give false-negative results.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Splenectomized subject
* Subject with severe babesiosis
* Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

Exclusion criteria:

- Subject having expressed opposition to participating in the study
Antioxidants and Pulmonary Rehabilitation in COPD Patients

On the basis of published data and investigators results indicating that systemic redox in balance may contribute to the peripheral muscle dysfunction in COPD patients, the investigators propose a study testing the effects of antioxidants and exercise training in COPD patients. The results may have major implication in the improvement of pulmonary rehabilitation benefits

COPD will constitute the third cause of mortality in 2012. This chronic respiratory disease is characterized by peripheral dysfunction of skeletal muscle which is associated with major clinical outcomes (prognostics, symptoms, and health related quality of life). Muscle and systemic oxidative stress has been incriminated in this peripheral muscle dysfunction.Exercise training constitute the main validated therapeutic intervention leading to significant muscle function and clinical improvement.Our preliminary results have shown that COPD patients experiment dietary and enzymatic antioxidants defects.Yet, generic antioxidant supplementation has not shown significant muscle function improvement.Therefore, we aim to test the effects of an antioxidant supplementation targeted on the antioxidant defects associated with exercise training on the peripheral muscle function, exercise tolerance and health quality of life in COPD patients.At the cellular level, this muscle dysfunction is related with a fiber atrophy and a metabolic switch (reduce proportion of oxidative fiber).This study will compare the effects of an antioxidant supplementation on the peripheral muscle function and skeletal muscle cellular properties in association with exercise training during a pulmonary rehabilitation course.Volunteers will be randomised in 2 groups: - 1 group treated with the antioxidant supplementation ( 28 days)- 1 group treated with the placeboIntervention will be allocated by chance and a double blind manner. Antioxidant supplementation will associate vitamins and trace elements that won't exceed the maximal nutritional dose recommended.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients, 40 years to 78 years, last exacerbation dating at least 4 weeks

Exclusion Criteria:

* unstabilized primary pathologies (cardiovascular, renal, metabolic, psychiatric)
* nutritional supplementation in the 4 weeks preceding the study (antioxidant, vitamins...)
Dentoskeletal Changes In The Transverse Dimension Using Tooth Bone-Borne Vs. Bone-Borne Expansion Appliances

This study aimed to investigate the skeletal, dentoalveolar, and periodontal changes of tooth-bone-borne (TBB) and bone-borne (BB) appliances with identical miniscrew placement using cone-beam computed tomography (CBCT) in the post-pubertal growth spurt stage.

Eighteen patients were divided into 2 groups: TBB group (n = 9, 16.11 ± 0.59 years of age) and BB group (n = 9, 15.33 ± 1.22 years of age). CBCT scans were obtained before treatment and after 3 months of expansion. Transverse skeletal and dental expansion, alveolar and tooth inclination, and buccal alveolar bone thickness were evaluated in maxillary first premolars and molars. Paired t tests and independent-sample t tests were used to compare the expansion appliances.

Eligibility Criteria:
Inclusion Criteria:

* With a unilateral or bilateral morphological lateral crossbite
* Whose first molars and premolars had completely erupted at pretreatment
* With maxillary constriction of more than 4 mm and less than 10 mm
* Who were going through the post-pubertal growth spurt stage based on hand-wrist radiographs

Exclusion Criteria:

* craniofacial anomalies
* compliance problems
* systemic or genetic disease
* previous orthodontic treatment history
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)

The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients aged ≥ 20 years of age at the day of obtaining the informed consent
* Patients with histologically confirmed diagnosis of the following:
* Peripheral T-cell Lymphoma, not otherwise specified (PTCL-NOS)
* Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)
* Angioimmunoblastic T-cell Lymphoma (AITL)
* Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy)
* Have at least 1 evaluable lesion
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Life expectancy of at least 3 months
Diagnosis and Characterization of Coronary Artery Stenosis by Doppler Ultrasound

The purpose of this study is to evaluate the feasibility of acquisition of coronary blood flow velocity signals over the whole length of the LAD with transthoracic pulsed Doppler, and to evaluate the diagnostic power of the transthoracic Doppler analysis package for detecting and estimating the degree of coronary artery stenosis. Finally we hope to optimize the currently available analysis package on the basis of the comparison of the Doppler with the angiographic stenosis results and evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are clinically suspected of having significant coronary artery stenosis.
* Patients with CAD.
* Patients who are scheduled to undergo coronary angiography.
* Signed informed consent.

Exclusion Criteria:

* Patients with arrhythmia / irregular pulse
* Patients with unstable conditions: unstable angina, uncontrolled CHF
* Patients with COPD
* Any physical or medical disability that prevent lying in supine position
* Patients with chest wall deformity
Cranberry for Prevention of Urinary Tract Infections in Multiple Sclerosis Patients

Bladder dysfunction occurs at some time in most patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections. Cranberry has been traditionally used for the treatment and prophylaxis of urinary tract infections but there is no reliable randomized controlled trial demonstrating evidence of cranberry's utility in this disease. The aim of our study is to assess the efficacy and safety of cranberry in the prophylaxis of urinary tract infections in patients with multiple sclerosis with a prospective randomized, double-blind and placebo-controlled clinical trial.

Bladder dysfunction occurs at some time in 70 to 90% of patients with multiple sclerosis and these patients are prone to have recurrent urinary tract infections (UTI), leading to an important morbidity. Cranberry has been traditionally used for the treatment and prevention of UTI and research suggests that its mechanism of action is preventing bacterial adherence to host cell surface membrane.

However, systematic reviews show the small sample sizes and the poor quality of available trials, determining that there is no reliable evidence of effectiveness of cranberry in UTI prophylaxis. Therefore, to assess whether cranberry is effective in reducing UTI in patients with multiple sclerosis, we have designed a randomized, double-blind, placebo-controlled trial. Efficacy will be evaluated on the time to onset of a UTI in the first year of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 70, with multiple sclerosis, neurologically stable for at least 3 months
* With an EDSS score ≥ 3
* Symptomatic bladder dysfunction: frequency, urgency, dysuria, incontinence (at least one of these symptoms), needing intermittent catheterization or not
* Ambulatory at inclusion
* Able to undergo evaluation
* Informed written consent

Non-inclusion Criteria:

* Regular consumption of cranberry within 3 months before inclusion
* Symptomatic urinary tract infection at inclusion
* Chronic renal failure (creatinin clearance \< 10ml/min)
* Patients with urinary permanent catheterization
* Patients with hyperuricemia and risk of uric acid lithiasis
* Patients with oral anticoagulant treatment (antivitamins K)
* Peptic ulcer
* Intolerance to cranberry and/or excipients
* Urinary tract infections antibioprophylaxis
Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell Lymphoma

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of lymphoma by blocking blood flow to the cancer. Giving fludarabine and cyclophosphamide together with thalidomide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with thalidomide works in treating patients with angioimmunoblastic T-cell lymphoma.

OBJECTIVES:

Primary

* Determine the response rate in patients with angioimmunoblastic T-cell lymphoma after chemotherapy comprising fludarabine and cyclophosphamide.

Secondary

* Assess the incremental anatomical and molecular response rate in these patients during treatment with thalidomide.
* Determine the toxicity of treatment with fludarabine and cyclophosphamide followed by thalidomide.
* Assess the progression-free and overall survival of these patients.
* Develop a detailed pathological description of the disease at presentation and at relapse.
* Assess the number of circulating clonal T cells at presentation and during thalidomide treatment.
* Screen for possible etiological viruses at presentation.
* Evaluate the evolution of EBV viral load during follow-up.

OUTLINE: This is a multicenter study.

Patients receive oral or IV fludarabine and oral or IV cyclophosphamide once daily on days 1-3. Courses repeat every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Beginning at least 4 weeks after completion of chemotherapy, patients who achieve at least stable disease receive oral thalidomide once daily for at least 6 months.

Lymph nodes, marrow, and peripheral blood will be collected periodically for research studies.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Newly diagnosed angioimmunoblastic T-cell lymphoma
* Measurable disease (i.e., anatomically assessable)

PATIENT CHARACTERISTICS:

* WHO/ECOG performance status 0-2
* Serum creatinine ≤ 2.5 times upper limit of normal (ULN)
* Bilirubin ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception before, during, and after study treatment
* No known seropositivity for hepatitis B virus, hepatitis C virus, or HIV
* No active second malignancy or other concomitant serious medical condition, in particular peripheral neuropathy

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy for angioimmunoblastic T-cell lymphoma
Correlation Between Sex and Prognosis of Acute Aortic Dissection in the Chinese Population

The study evaluated the prevalence, presentation, management, and prognosis of coronary heart disease differ according to sex.

The study included 884 patients enrolled in our institute between June 2002 and May 2016. Considering psychosocial factors, treatments, and the outcomes in men versus those in women with acute aortic dissection, explored the association of sex with psychosocial characteristics and mortality risk. Of 884 patients, 211 (23.9%) were women. The median duration of follow-up was 2.9 years (25th -75th percentiles: 1-4 years ).

Eligibility Criteria:
Inclusion Criteria:

* acute aortic dissection

Exclusion Criteria:

* Chronic aortic dissection
Reducing Head Motion With Customized Head Mold in Young Children

The purpose of this study is to assess the safety and efficacy of a customized head mold for reducing head motion during MRI scanning in young children.

Each participant completed a dedicated session for mock scanning before we acquired two sets of sMRI and fMRI scans. One scan set was collected using the head mold and the other without, and the scans were counterbalanced in order across participants. Using a specialized sMRI sequence embedded with vNAVs, we directly measured head motion during sMRI in order to more accurately evaluate the head mold's impact on structural metrics. To evaluate the feasibility and tolerability of the head mold, we concluded the scanning sessions with a brief interview that gauged participants' scanning experience and tolerance of the head mold. We investigated whether head molds would reduce head motion compared to standard scanning procedures and whether those reductions would result in improved data quality. We also tested the extent to which reductions in head motion impacted estimations of cortical volume and functional connectivity. Prior to data collection, we evaluated the noise dosage levels of the head mold condition, given the limited space available for additional hearing protection devices in the head coil while the head mold is on. We also assessed whether the head molds could balance head motion between typical and ADHD populations, and whether clinical variables such as ADHD diagnosis and trait anxiety, as determined by parent-reported dimensional measures, can predict head mold efficacy.

Eligibility Criteria:
Inclusion Criteria:

* between ages 5 - 10
* ADHD diagnosis as determined by parent self-report

Exclusion Criteria:

* no MRI contraindications and no history of head injuries or seizures.