cyrilzakka/clinical-trials huggingface dataset:
Collection of Samples of Bone Marrow Aspiration From Patients With Myelodysplastic Syndrome

The study Objective is to collect samples of bone marrow aspirates and peripheral blood of patients with MDS for use in non-clinical research to investigate mitochondrial function sequence and effect of mitochondrial augmentation.

Mitochondrial dysfunction is often associated with MDS. Studies have shown mitochondrial DNA (mtDNA) mutations in different MDS subtypes; however, their role in the pathogenesis and disease progression are not yet clear. Point mutations were found in various locations in the mitochondrial genome including tRNAs, rRNAs, and mitochondrial proteins.

Mitochondrial fragmentation in hematopoietic stem and progenitor cells (HSPC) can lead to ineffective hematopoiesis in MDS, suggesting mitochondria as a therapeutic target for treating MDS.

Mitochondria augmentation therapy (MAT) is a novel cell technology where hematopoietic stem and progenitor cells (HSPCs) are augmented ex vivo with mitochondria obtained from donor cells or tissue. MAT is based on the demonstrated ability of isolated mitochondria to enter cells and impact mitochondrial function and metabolic activity in the recipient cells. The transfer of mitochondria from cell to cell has been demonstrated using extracellular vesicles, nanotubes, and micropinocytosis. Mitochondria entering cells provide copies of normal mtDNA, which can be further propagated via replication within the recipient cell and via intercellular transfer.

Research will include in vitro and in vivo studies with the bone marrow sample, including, among other, the following: mitochondrial augmentation of bone marrow aspiration and/or subpopulations of cells (e.g. CD34+) isolated from the bone marrow aspiration; differentiation of augmented and/or non-augmented bone marrow aspiration and/or subpopulations of cells into hematopoietic lineages (e.g. erythroid, megakaryocyte, etc); assays of mitochondrial content and function; assays of hematopoietic lineages; culture of augmented and/or non-augmented bone marrow aspiration and/or subpopulations; cryopreservation of augmented and/or non-augmented bone marrow aspiration and/or subpopulations; sequencing of mitochondrial DNA and nuclear DNA; in vivo studies of engraftment, biodistribution and function of augmented and/or non-augmented bone marrow aspiration and/or subpopulations of cells isolated from the bone marrow aspiration.

Research will include in vitro studies with the peripheral blood sample, including, among other, the following: immunophenotyping of peripheral blood cells and immune-related functional assays; mitochondrial content and function of peripheral blood cells.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients of 18 years old and up.
2. Suspected or previously diagnosed with Myelodysplastic Syndrome.
3. Patient able to understand and provide voluntary written informed consent.

Exclusion Criteria:

1. History of prior allogeneic hematopoietic stem cell transplantation, cell therapy, gene therapy.
A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms

This study was a prospective observational study examined the safety of the TriVascular AAA Stent-Graft System in the elective treatment of patients with abdominal aortic aneurysms. Specifically, the study will evaluate the safety of the TriVascualr AAA Stent-Graft System, evaluate the ability to deliver the Tri-Vascular AAA Stent-Graft System to the desired location within the aorta, and evaluate the ability of the TriVascular AAA Stent-Graft to exclude the abdominal aortic aneurysm.


Eligibility Criteria:
Inclusion Criteria:

* Male or infertile female
* Have signed an informed consent form.
* Are considered an appropriate candidate for open surgical repair of an abdominal aortic aneurysm.
* at least one of the following: Abdominal aortic aneurysm \>= 4.5 cm in diameter; aneurysm has increased in size by 0.5cm in last 6 months; maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent normal aortic segment; saccular aneurysm larger than 3 cm.
* Have patent iliac or femoral arteries that allow endovascular access to the aneurysmal site with a 17F Delivery Catheter.

Exclusion Criteria:

* A dissecting, acutely ruptured, or leaking aneurysm, or an acute vascular injury due to trauma.
* A need for emergent surgery.
* contraindication to undergoing angiography.
* A Thoracic aortic aneurysm that requires treatment.
* Presence of thrombus or atheroma in proximal aortic neck covering \> 50% of the endoluminal surface.
* Presence of diffuse atherosclerotic disease in either common iliac artery that reduces the iliac artery diameter to \<7mm.
* Congenital abnormalities in which the placement of the stent-graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated(e.g. angiography or CT) prior to treatment.
* Unstable angina
* Morbid obesity or other clinical conditions that severely inhibit x-ray visualization of the aorta.
* Connective tissue disease (e.g., Marfan's or Ehlers-Danlos syndrome.)
* Hypercoagulable state.
* Contraindication for anticoagulation.
* Acute renal failure.
* Active systemic infection.
* less than 18 years of age.
* Life expectancy less than 1 year.
* Current, or anticipated participation within 1 year, in another research study involving an investigational device or new drug (with the exception of participation in the Lifeline Registry of Endovascular Therapy).
* Other medical, social, or psychological issues that in the opinion of the investigator preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment.
Telerehabilitation vs. in Presence Rehabilitation of Reading Disorders Using the Rhythmic Reading Training (RRT)

The aim of the study is to compare the effectiveness of telerehabilitation vs. in presence rehabilitation of reading disorders, using a rhythm-based intervention for reading (i.e., Rhythmic Reading Training)


Eligibility Criteria:
Inclusion Criteria:

* having been diagnosed with DD (ICD-10 code: F81.0) on the basis of standard inclusion and exclusion criteria (ICD-10: World Health Organization, 1992) and of the diagnosis procedure followed in the Italian practice

Exclusion Criteria:

* presence of comorbidity with other neuropsychiatric or psychopathological conditions
* having been involved in previous reading intervention programs in the previous 3 months
LISA Catheter With Marked vs. Unmarked Tip in Extremely Low Birth Weight Infants With RDS

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Although less invasive surfactant administration (LISA) offers some advantages in ventilation procedure and neonatal outcomes, achieving the correct depth in the trachea using a LISA catheter may be difficult. This may have some drawbacks such as impaired surfactant administration (reducing the efficacy of the procedure) or prolonged duration of the laryngoscopy (aggravating the invasiveness of the procedure).

The aims of the present study should be: i) positioning of the device at the correct depth in the trachea, ii) time and number of attempts to achieve the correct depth, iii) participant satisfaction.

This is an unblinded, randomized, controlled, crossover (AB/BA) trial of surfactant treatment with LISA catheter with a marked tip vs. LISA catheter with an unmarked tip in a manikin simulating an extremely low birth weight infant. Participants will be level III NICU consultants and residents. Randomization will be performed using a computer-generated random assignment list. The primary outcome measure will be the positioning of the device at the correct depth in the trachea. The secondary outcome measures will be the time and number of attempts to achieve the correct depth and participant satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Level III NICU consultants and residents will be eligible to participate in the study

Exclusion Criteria:

* Refusal to participate in the study.
Clinical Characteristics and Outcome of Patients with Hemorrhagic Stroke Admitted in Neurology Department in a Tertiary Hospital

The main aim of this study is to know about the clinical profile of patients who are diagnosed as hemorrhagic stroke as well as the factors that affect good and bad outcomes of those patients after 3 months. Patients will be required to follow up in medical OPD of the same institution after 3 months.

This was a prospective observational study conducted on 197 patients of ≥ 18 years of age admitted with the diagnosis of hemorrhagic stroke in Tribhuvan University Teaching Hospital, a tertiary hospital in Nepal from April 1 2023 to March 31, 2024. Patients who do not give consent or with post-traumatic hemorrhages, hemorrhagic transformation of an ischemic stroke, or any intracranial hemorrhages other than primary intracranial hemorrhages were excluded from the study. The study protocol and design were reviewed and approved by the Institutional Review Committee of Tribhuvan University Teaching Hospital \[Ref. 437 (6-11) E2\]. Data was collected in a structured proforma.

The primary outcome of this study was to assess the functional outcome of the patients at 3 months of follow-up. The modified Rankin scale (mRS) was assessed in an outpatient setting during the follow-up. If patients did not attend the 3-month follow-up, mRS was assessed by telephone conversation. Clinical outcome was dichotomously categorized as good outcome if mRS was 0-2 and bad outcome if mRS was ≥ 3.

Analysis for categorical data was done by Chi-squared test, Fisher's exact test. Analysis for continuous data was done using either parametric tests like the t-test, or non-parametric tests like the Mann-Whitney U test depending on the distribution of data. Predictors of clinical outcomes were analyzed using multivariate logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed case of hemorrhagic stroke

Exclusion Criteria:

* Does not give consent
* Post-traumatic hemorrhages, hemorrhagic transformation of an ischemic stroke, or any intracranial hemorrhages other than primary intracranial hemorrhages were excluded from the study
Knee Pain Phenotypes in the Community Study

The focus of the study is to determine the prevalence and variance of self-reported knee pain characteristics in a community-derived sample of adults aged 40 years and over. It will also identify characteristics such as structural changes of osteoarthritis of the knee as well as physiological parameters and blood and urine biomarkers.

Number of participants:

Part I: questionnaire to 40,000 people aged 40 years and over (giving an expected 10,000 respondents) Part II: 400 participants.

Eligibility Criteria:
Inclusion criteria:

* Aged 40 years and over

Exclusion criteria:

* Inability to give informed consent
* Terminal or mental illness
* Pregnant women
An Outcomes Study Comparing the Intralase FS 60 to the Intralase iFS When Performing LASIK Surgery for Nearsightedness

The purpose of the study is to compare the results of LASIK surgery when using two versions of a femtosecond laser in patients with nearsightedness with and without astigmatism.

The patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then we will inform the patient and make an appropriate referral. if the patient is deemed appropriate for the study after a comprehensive examination included computerized videokeratography, then they can be enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase FS 60 and which eye is treated with Intralase IFS will be randomized so there is a 50% chance for either eye to receive one treatment. The patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. The patient will receive topical antibiotics in each eye for one week following the procedure. The patient will receive pred forte 1% ophthalmic drops for one week after treatment. The patient will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.

Eligibility Criteria:
Inclusion Criteria:

* Subjects age 21 and older with healthy eyes.
* Nearsightedness between -0.25 diopters and -7.00 diopters with or without astigmatism of up to 3.00 diopters.

Exclusion Criteria:

* Subjects under the age of 21.
* Patients with excessively thin corneas.
* Patients with topographic evidence of keratoconus.
* Patients with ectactic eye disorders.
* Patients with autoimmune diseases.
GPS Project Evaluation of the Impact of the Reorganization of Work Into a Family Medicine Group on Pharmacotherapy and Support for the Autonomy of Seniors With Major Neurocognitive Disorders

The model of care tested in the GPS project aims to optimize pharmacotherapy for seniors undergoing cognitive assessment or suffering from major neurocognitive disorder (MCND) at home. The goal is to reduce polymedication, inappropriate medications and the treatment burden of seniors and to maintain their cognitive health, quality of life and autonomy. The intervention will include knowledge exchange sessions with nurses, pharmacists, and doctors in FMGs, and increased collaboration between these professionals and home care services teams. Other goal is to increase the satisfaction of the seniors, their families, and the professionals involved in the GPS project.

: The GPS project is part of the desire to keep seniors with major neurocognitive disorder (MCND) in their homes for as long as possible. Medication can contribute to cognitive loss in seniors and affect their functional autonomy. The arrival of pharmacists in FMGs and the expansion of their practice is opening up new opportunities to promote interdisciplinary collaboration and optimize pharmacotherapy for seniors. During the project, a new model of care, called GPS, is being tested with seniors. A group of seniors (approximately 200) will receive the new care team's new interventions in the FMGs in the "intervention" group. Another group of seniors (about 200) will receive the usual care in other FMGs that will serve as a "control" group. By comparing the results of the two groups, it will be possible to evaluate the effects of new interventions. A period of 12 months will be allocated for the inclusion of seniors. The follow-up of each senior will be approximately 6 months.

Eligibility Criteria:
Inclusion Criteria:

* All seniors (65 years of age or older) undergoing cognitive evaluation OR referred to a memory clinic OR having been diagnosed with cognitive impairment within the last year OR with MCND and followed up at home AND,
* referred to the pharmacist, for the FMGs exposed
* taking prescription medications

Exclusion Criteria:

* Seniors in palliative care OR
* unable to answer questionnaires in French AND without a caregiver.
A Risk Scores for Predicting Prevalence of Diabetes in the LAO Population

This was a cross-sectional investigation conducted from December 2015 to July 2017, in 15 selected rural villages of 2 districts of Vientiane municipality, Lao PDR. Target population was interested people, both men and women of age range between 30 to 70 years, living in the selected community. Someone diagnosed with diabetes and/or using any anti-diabetic drug was excluded.

The study protocol initiated with the interview on demographic and behavior information with each participant, followed by physical exam and blood pressure measurement.

Fasting glucose were measured.

All participants were invited to meet with the researcher.

Demographic data comprises of age, gender, family history of diabetes including parents and sibling, female with history of having baby weighing more than 4 kg, gestational diabetes, and history or current of dyslipidemia (triglycerides \>150 mg/dl, LDL-C ≥ 100 mg/dl, HDL-c \< 35 mg/dl), and behavior data were smoking habit, physical inactivity (less than 150 min/week or 3 day/week) were collected by interview.

After that each participant was appointed for blood pressure measurement. Body mass index was computed from body weight (kg) divided by body height (m2) using the weight and height scale.

Waist Circumference was measured at the midpoint between the superior border of iliac crest and the lowest rib using measuring tape with the subject in the position of standing relax and in underclothes

Hip circumference is measured at the level of maximal gluteal protrusion

Blood pressure (BP) value was done with the participants, after 5 minutes relaxing, sitting up right with their upper arm positioned at heart level and measured by Omron blood pressure monitor.

Fasting Plasma Glucose was utilized to identify an individual who is normal, has either pre-diabetes or undiagnosed diabetes. Venous blood samples were collected 5 ml from antecubital vein into the test tube

Eligibility Criteria:
Inclusion Criteria:

* of age range between 30 to 70 years, living in the selected community.

Exclusion Criteria:

* diagnosed with diabetes and/or using any anti-diabetic drug
Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.

A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis and without any cardiovascular disease.

A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis and without any cardiovascular disease.

60 patients: 30 with periodontitis and 30 with healthy controls and without periodontitis history.

All the patients are assessed for clinical, periodontal, blood and non-invasive ultrasound cardiovascular parameters. Measurements are taken before and after initial periodontal treatment in the periodontal subjects.

Eligibility Criteria:
PERIODONTITIS GROUP

Inclusion Criteria:

* Clinically diagnosed with periodontitis according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Cardiovascular Diseases.

HEALTHY GROUP

Inclusion Criteria:

* Clinically diagnosed with healthy periodontum withouth periodontitis history according to the EFP/AAP 2017 criteria.

Exclusion Criteria:

* Scaling, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
* Pregnancy.
* Cardiovascular Diseases.
Effect of Erythromycin Before Endoscopy of Patients With Subtotal Gastrectomy (STG), High Risk of Gastric Stasis

Erythromycin has a prokinetic effect through Motilin receptor. It evokes migrating motor complex with longer and stronger contraction.

In patients with upper gastrointestinal bleeding, It has been shown that erythromycin could clear the stomach of blood, so visual examination could be improved.

Frequent food stasis is encounted when we examine patients with subtotal gastrectomy. It is postulated that erythromycin reduce food stasis and help to improve endoscopy in these cases.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergone STG (billroth I, billroth II, R-Y STG) within 5 years to treat gastric cancer
* Stage of T1-2N0M0

Exclusion Criteria:

* concomitant therapy with astemizole, cisapride, dihydroergotamine, ergotamine, pimozide, or terfenadine, narcotics, alpha-2-adrenergic agonist, TCA, CCB, dopamine agonist, muscarinic cholinergic antagonists, octreotide, exenatide and GLP-1 agonist, phenothiazines
* chemotherapy Hx.
* hypersensitivity to erythromycin or any component of the product
* pregnancy or lactation
* comobidity : DM, AIDS, neurologic disease(parkinsonism, multiple sclerosis, brainstem stroke or tumor, diabetic or amyloid neuropathy, or primary dysautonomias) scleroderma and other connective tissue disease, recent viral enteritis history
* recurrence
Aging With Dignity, Health, Optimism and Community

ADHOC is an observational study of people living with HIV over the age of 50. Data from this study will be used to research the interaction between HIV and aging.

ADHOC is an observational study that collects data on PLWH over the age of 50 using an online questionnaire. The questionnaire includes information on sociodemographic factors, activities and interests, HIV diagnosis and status, health care use and satisfaction, antiretroviral therapy, comorbid medical conditions, health and well-being, substance use, and sexual practices.

Eligibility Criteria:
Eligibility criteria:

* have an HIV-1 or -2 infection,
* be ≥ 50 years of age,
* have no known acute medical problems requiring immediate inpatient treatment,
* be able to read and write in English, and
* be able and willing to provide online informed consent and complete the profile online.
Validation and Inverse Analysis of The Athletic Shoulder Test (ASH).

To validate both the Athletic Shoulder (ASH) test, conducted on rugby players, and its inverse, the Inverse Athletic Shoulder (IASH) test, for swimmers. This involves assessing the strength relationship between shoulder flexion and extension at three different adduction angles (180º, 135º, 90º) to identify potential injuries associated with these imbalances.


Eligibility Criteria:
Inclusion Criteria:

* High-performance swimmers.
* Aged between 14 and 18 years.
* No acute injuries in the cervical or scapular region.
* Ability to perform the ASH and IASH tests without compensatory movements.

Exclusion Criteria:

* Acute injuries in the cervical or scapular region.
* Inability to maintain proper positioning during the tests due to lack of adequate mobility or strength.
* Refusal to sign informed consent (or legal guardian's consent for minors).
Rheos System for the Treatment of HFpEF Heart Failure

The purpose of this clinical investigation (NCT00957073) is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial, utilizing the BAROSTIM NEO™ LEGACY device for Implantable Pulse Generator (IPG) replacements.

The initial trial design randomized subjects in a 2:1 ratio to receive a Rheos system plus medical management (Device Arm) or to receive medical management alone (Medical Management Arm). On March 24, 2011, the study closed to enrollment before adequate endpoint data was collected and before enrollment was completed; 19 subjects had been randomized, 10 device and 9 medical management. Medical management subjects were withdrawn from the study and subjects who had been implanted with the device were given the opportunity to continue in the study under long-term follow-up; 8 of the 10 device subjects continued in the study. Long-term follow-up visits occurred at 15 and 18 months post-randomization; visits occur semi-annually until study closure.

The study was not stopped for safety or futility, but for business/strategic reasons due to production of a new generation of the device.

Eligibility Criteria:
Inclusion Criteria:

1. Currently implanted with the Rheos device and actively participating in the HOPE4HF Trial (G090001).
2. Have signed a CVRx, FDA and Institutional Review Board (IRB) approved informed consent form for participation in this study.

Exclusion Criteria:

1. Treating physician decision that the subject should not continue with therapy.