cyrilzakka/clinical-trials huggingface dataset:
Pole Walking Intervention in Retirement Communities

This patient-oriented study aims to co-design and pilot a pole walking intervention with residents and staff of the participating independent living/retirement communities. The proposed pilot will answer the following principal question: Is pole walking intervention feasible in the independent living/retirement communities? We will also assess if pole walking intervention will be associated with improved physical activity, function, mobility and quality of life. The final format of the intervention will be designed with resident- and staff-advisors. We anticipate that the pole walking sessions will be held outdoors, 2-3 times a week, for 20-60 min/session, over 12 weeks.

Pole walking provides an attractive form of exercise therapy for older adults. It is a simple, well-tolerated and effective means to improve overall functional fitness in older adults. Pole walking has improved upper and lower body muscle strength, cardiovascular endurance, and flexibility in community dwelling older adults. It has been positively associated with balance, functional mobility, muscle strength, and aerobic exercise capacity in older adults. Pole walking is considered to offer a safe format for walking as poles provide support and help with balance and thus, contribute to confidence in being active. However, there has not yet been a study assessing the feasibility of pole walking intervention in older adults living in independent living/retirement communities.

This study is a patient-oriented pilot intervention. Our target is to include 50 independent living/retirement community's residents. Pole walking exercises are based on ongoing, patient-oriented Nordic Walking intervention, tailored for participants and progressive in nature. Training sessions will be led by trained peer/staff/student-instructors. Training sessions will be held outdoors, 2-3 times a week, for 20-60 min/session, over 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Being an ambulatory resident in the independent living/retirement
* Pass the Get Active Questionnaire. If the participant has heart conditions, angina during daily living, balance, and bone or joint problems, then a Physician Clearance Form is required to be filled out and signed by the participant's family physician.

Exclusion Criteria:

* Using assistive devices for mobility
* Being active (moderate-to-vigorous physical activity\>1h/week)
* Diagnosed with Parkinson's disease
A Retrospective Study on Epidemiological Characteristics of Chinese NF1 Patients in Real World (PROMISE)

Background/Rationale: Neurofibromatosis type 1 (NF1) affects about 1 in every 3000 people worldwide. Globally, 30\~50% NF1 patients will develop plexiform neurofibromas (PNs), which grow rapidly in early childhood and can cause disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder and bowel dysfunction. This systemic disease imposes a heavy psychosomatic and financial burden on patients and their caregivers. In NF1 patients, the lifetime risk of MPNST developed from PN is 8% to 13%. The mean age for NF1-associated death was approximately 20 years lower than that for the general population. Limited epidemiological and clinical data of Chinese NF1 patients is available to date. And the treatment pattern of Chinese NF1-PN patients is also unknown.

Objectives and Hypotheses: It is a descriptive study without formal hypothesis. The primary objective of this study is determining the percentage of NF1 patients who develop PN. The secondary objectives of this study include describing the clinical characteristics, tumor progression and treatment pattern of NF1-PN. The exploratory objective is exploring the epidemiological characteristics of other NF1 manifestations.

Methods:

Study design: The study is a retrospective multi-center chart review study. Data Source(s): All the data will be collected by CRF from inpatient and outpatient electronic medical records in every study site from January 1, 2019 to December 31, 2022.

Study Population: Patients who attended the study sites between January 1, 2019 - December 31, 2022 and were diagnosed with NF1 were included in this study. Statistical Analysis: This study is purely descriptive without any formal hypotheses.

Missing data for baseline characteristics will be assessed and addressed as a categorical variable with a level for missingness. All reported measures will be summarized in the study tables. Point estimates and their 95% CIs will be presented in the final analyses.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who attended the study sites between January 1, 2019, and December 31, 2022.
2. Patients who were diagnosed with NF1(recorded with the text of type I neurofibromatosis) based on National Institutes of Health (NIH) NF1 consensus.

Exclusion Criteria:

1. Patients combined with other malignant tumors
Parturient Microcirculation

This is an observational study comparing microcirculation of pregnant to non-pregnant women. "Microcirculation" means blood flow to the extremely small blood vessels in one's body. During pregnancy the amount of blood in a woman's body increases. The body responds to this increase by pumping more blood through the heart and narrowing the size of blood vessels.

There are many types of blood vessels that have different roles in the body. Larger blood vessels. Transport blood to and from body organs like the brain and liver. Small vessels (microcirculation)distributes blood to the organ tissues. The microcirculation can change blood flow and blood pressure. Microcirculation is involved in delivering oxygen and nutrients to your body, removing waste products, and regulating body temperature.

The investigators current understanding of the microcirculation in pregnant women is limited. There is a device available that can measure microcirculation. It is known as Sidestream Dark Field (SDF) imaging. It is a special type of camera that captures pictures of the microcirculation. In this study the investigators will compare the microcirculation, as seen with SDF imaging, of pregnant women to non-pregnant women. By improving the investigators understanding of maternal microcirculation the investigators are adding to the knowledge of how the pregnant body works. The investigators hope to then translate this knowledge into further studies to improve maternal and fetal outcomes through prevention and treatment of maternal low blood pressure caused by spinal anesthesia.

The objectives of this observational trial are; to compare the sublingual microcirculation of pregnant subjects to that of comparable non-pregnant volunteers; to evaluate the usefulness of a non-invasive technology, SDF imaging in pregnant and non-pregnant subjects.

By improving our understanding of maternal microcirculation we not only add to the knowledge of maternal physiology, we hope to then translate this knowledge into further studies to improve maternal and fetal clinical outcomes through prevention and treatment of maternal hypotension especially in relation to spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status I-II (ASA I Healthy, ASA II - mild and controlled systemic disease)
* Pregnant: singleton, 36 - 40 weeks EGA, non-labouring
* Non- Pregnant - Healthy female volunteers who have never been pregnant, matched to pregnant patients for age ± 1 year

Exclusion Criteria:

* Obesity (BMI \> 35 kg/m2)
* Hypertensive disease (Essential, gestational, or preeclampsia)
* Diabetes Mellitus Type 1
* Cardiovascular disease
* Smoker (1 cigarette or other tobacco product within 12 months)
* Caffeinated (i.e. coffee, tea, energy drink) beverage with 2 hours
Autoimmune Cytopenia: Genetics and Pathophysiological Mechanism in Pediatric Evans Syndrome

Characterization of the genetic causes, and of the immunopathological clinical and biological manifestations in children with pediatric Evans syndrome included in a prospective national observational cohort of rare diseases.

Pediatric Evans syndrome (pES) is a rare and severe disease combining immunologic thrombocytopenic purpura (ITP) and autoimmune hemolytic anemia (AIHA). French patients from the 30 hematologic pediatric centers are from 2004 included in a prospective national OBS'CEREVANCE cohort.

A first pilot study revealed a monogenic cause in 7/18 patients (40%) with mutations in the CTLA-4, LRBA, STAT3 GOF, and KRAS. TNGS or exome studies were performed between 2015 and 2018 inn 80 patients with pSE from the OBS'CEREVANCE cohort. This approach, combined with by immunophenotyping lymphocyte, identified a genetic cause of the disease in 26 patients (32%) (TNFRSF6, CTLA4, LRBA, STAT3 GOF, PIK3CD, RAG1, KRAS) and potential causal mutations in 18 other patients (22%), bringing the proportion of potential single gene cause to 76%.

The central hypothesis of this study is that most, if not all, cases of pSE are related to a monogenic or digenic cause, possibly with the intervention of genetic modifiers such as somatic mutations.

Eligibility Criteria:
Inclusion Criteria:

* Patient registered in the French national prospective OBS'CEREVANCE cohort
* Diagnosis of pediatric Evans syndrome (PTI+AHAI)
* Age strictly under 18 years at the initial onset
* Child residing in metropolitan France and affiliated to a french health insurance system
* Free, informed, written and signed consent

Exclusion Criteria:

* Evans syndrome secondary to chemotherapy, bone marrow transplantation or organ transplantation.
* Refusal to participate from parents/patients
Dimercaptosuccinic Acid (DMSA) Treatment of Children With Autism and Heavy Metal Toxicity

Many children with autism have a reduced level of glutathione and a reduced ability to excrete mercury, resulting in elevated levels in their bodies as demonstrated by blood, hair, provoked urine, and baby tooth testing. Our earlier studies have demonstrated that DMSA, an FDA-approved medication for treating lead poisoning in children, is effective in increasing excretion of mercury and other toxic metals. Based on many clinical reports, we hypothesize that a 3-month treatment with glutathione and DMSA will result in a reduction of autistic symptoms in some children with autism.

This study will assess the safety and efficacy of the use of DMSA (an FDA-approved medication for treating lead poisoning in children) for the off-label treatment of symptoms of autism in children with autism and significant body burden of toxic metals.

Eligibility Criteria:
Inclusion Criteria:

Phase One

1. Children with autism spectrum disorder
2. Age 3-8 years (up to the day before the ninth birthday).
3. At least a two-month history of taking a multi-vitamin/mineral supplement with at least the RDA of zinc, and continuing to take that during Phase One and Two.

Phase Two:

1. Excretion of high amounts of toxic metals in phase one
2. Normal kidney/liver function, serum transaminases, and Complete Blood Count (CBC) (based on a blood test which will be conducted as part of Phase Two)
3. No changes in medication, supplements, diet, or behavioral interventions during the study

Exclusion Criteria:

Phase One and Two:

* No mercury amalgam dental fillings.
* No previous use of DMSA or other prescription chelators (except for 1-time challenges).
* No anemia or currently being treated for anemia due to low iron.
* No known allergies to DMSA
* No liver or kidney disease
Mannitol Use During Partial Nephrectomy Prior to Renal Ischemia and Impact on Renal Function Outcomes

The purpose of this study is to determine if a medication called mannitol, can help the kidney maintain its function after kidney surgery. Mannitol is used to cause an increase in urine production (it is a diuretic). For many years, mannitol has been given to patients in the hope it would improve the kidney's circulation, and in doing so reduce the impact of the surgery on the kidney.

Mannitol is given during the surgery before the blood supply to the kidney is stopped. The blood supply to the kidney is stopped in order to minimize any blood loss during the removal of the tumor, and also to assist the surgeons view of the kidney anatomy. Once the tumor is removed the blood supply to the kidney is resumed. Sometimes a side effect of this temporary reduction in blood supply to the kidney is the loss of some kidney function. This may happen either in the short term (right away) or long term (months or years later). In studies done on animals, mannitol was able to lessen this damage to kidney function. However, no human study has ever confirmed that mannitol has the same helpful effect in humans. There is some suggestion that it may have no effect. Because sufficient research has yet to be done on humans, many surgeons do not give mannitol. A recent study, conducted at Memorial Sloan Kettering which looked back at patients who had undergone partial nephrectomies, an operation where only the portion of the kidney that contains the tumor is removed and enables the normal, unaffected portion of the kidney to be preserved. The results of this study demonstrated no significant difference in kidney function when the investigators compared patients who were given mannitol to those who were not. The investigators hope that this study will help clarify the effectiveness or not of mannitol on kidney function. During the surgery to remove the kidney tumor, patients will receive either mannitol or a placebo. A placebo, is a harmless medication that has no effects. The impact of mannitol compared to the placebo will be assessed by routine blood tests and imaging (kidney scan) 6 months after your surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = to 18 years
* Scheduled for partial nephrectomy at MSKCC (open or minimally invasive technique) during which renal ischemia is anticipated
* Preoperative eGFR \> 45 cc/min/1.73m2 as measured by the CKD-EPI study equation

Exclusion Criteria:

* Allergy to mannitol
* Severe renal impairment (stage 3B) defined as eGFR \< 45 cc/min/1.73m2 as measured by the CKD-EPI calculation.
* Combined major surgical cases that include a partial nephrectomy.
Healing Circles: An Intervention for Canadian Indigenous Mothers & Children Affected by IPV

Evaluation of Mother's Empowerment Program and Kid's Club Program adapted specifically for Indigenous mothers and children affected by intimate partner violence in Canada

Research Goals \& Objectives. Our overall goal is to conduct a feasibility study of two successful evidence-based interventions (Mother's Empowerment Program and Kid's Club Program) designed specifically to meet the needs of Indigenous mothers and their children who have experienced intimate partner violence (IPV).

Specifically, our objectives are:

1. To successfully adapt two existing effective evidence-based interventions for mothers and children who have experienced IPV for Indigenous mothers and children who have experienced IPV. Our adaptation process reflects our overall integrated knowledge translation (iKT) approach, undertaken in close partnership with our Community Advisory Council (CAC) and in consultation with Elders at both sites. As outlined by the Canadian Institutes of Health Research (CIHR), it follows a two-eyed seeing approach, incorporating Western and Indigenous knowledge, ways of knowing and being.
2. To pilot and evaluate our adapted interventions with mothers and children recruited from our community partners (Wahbung Abinoonjiiag, an Indigenous non-profit organization in Winnipeg and Discovery House, a crisis shelter and second stage housing facility for women in Calgary). We plan to evaluate our adapted programs using a two-eyed seeing approach that combines Western (quantitative) and Indigenous (qualitative) methodologies. As part of our iKT approach, our mixed methods evaluation will rely upon ongoing engagement and feedback from our CAC. Quantitative methods (e.g., standardized questionnaires) will be used to assess changes in the mental and physical health and well-being of mothers and their children over time. Qualitative methods (e.g., semi-structured interviews, narratives) will be used to evaluate the intervention experience and perceived changes in self perceptions (e.g., resilience).

Hypotheses. We will determine if there is an increase, both immediately post-intervention and sustained over 6-8 months, in mothers' and children's mental (e.g., resilience) and physical well-being (e.g., perceived health status), and if there is a reduction in mothers' and children's mental health (e.g., depression, anxiety and traumatic stress symptoms) and physical difficulties (e.g., somatic symptoms such as headaches). For children, analyses will take age, gender and sex into account.

Eligibility Criteria:
Inclusion Criteria:

* mothers self-reported experience of past intimate partner violence, English-speaking, with at least one school-aged child

Exclusion Criteria:

-
E-T Tube Cuff Pressure Change After Changing Position From Neutral to Hyperextension of Neck

This study evaluates difference of the endotracheal tube cuff pressure between a tapered- versus a cylindrical- shaped cuff after changing from neutral to hyperextension of neck.

Fifty patients undergoing thyroidectomy are randomly allocated into two groups (tapered- and cylindrical-shaped cuff). Endotracheal tube cuff pressure is initially set at 20 cmH20 in the supine neutral position and is measured after the change to the neck extension.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical classification 1-3, 18-70 year old, thyroidectomy

Exclusion Criteria:

* difficult intubation, history of cervical disease, motion limitation of neck, morbid obesity
Telehealth to Improve Functional Status and Quality of Life in Veterans With PAD

The present study aims to increase Veteran access to supervised exercise therapy and expand its role in improving functional status, quality of life, and cardiovascular risk profile of Veterans with PAD.

The investigators will use the VA Telehealth service to deploy a remotely accessible supervised exercise training program and evaluate whether a telehealth-based intervention can improve walking performance, quality of life, and ultimately cardiac risk in Veterans with PAD. The impetus for the current proposal stems from the following: 1) over 50% of VA-enrolled Veterans live in rural communities; 2) Veterans with PAD are older (mean age, 70 years), further increasing their risk for functional decline; and 3) there is a significant lack of access to facility-based supervised exercise training for Veterans with PAD. The objectives include the following:

1. To develop a telehealth-facilitated exercise intervention for Veterans with PAD that serves as a Veteran centric new model of care.
2. To integrate Veteran preferences into the development of a telehealth-facilitated supervised exercise program.
3. To assess the long-term patterns of functional impairment and quality of life among Veterans with PAD not undergoing supervised exercise training.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PAD, defined as a history of an ankle-brachial index (ABI) of 0.90, prior revascularization of a lower limb for symptomatic disease more than 30 days prior to presentation, or ABI \>0.90 with evidence of PAD based on noninvasive vascular laboratory testing or angiography

  * \[and presence of claudication, defined as fatigue, discomfort, cramping or pain of vascular origin in the muscles of the lower extremities that is consistently induced by exercise and consistently relieved by rest within 10 minutes.\]
* In addition, participants will require access to cellular signal at place of residence and/or exercise location

Exclusion Criteria:

* Justification for exclusion criteria centers on inability to safely participate in the remote intervention. Specific exclusion criteria includes the following:
* major lower extremity amputation
* critical limb ischemia
* inability to ambulate without a walker or wheelchair
* significant visual or hearing impairment
* individuals whose function is limited by severe conditions such as severe ischemic heart disease or \> Class II NYHA heart failure
* individuals capable of ambulating at a level comparable to the amount of exercise to be prescribed at baseline
* individuals currently enrolled in another exercise trial or cardiac rehab program
* individuals with uncontrolled psychiatric illness or dementia
* categorically vulnerable

  * pregnant women, prisoners, children, or persons who lack decision-making capacity
Treatment of Binge Eating in Obese Patients in Primary Care

This study will test the effectiveness of two empirically-supported but distinct treatments for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered alone and in combination in a primary care setting.


Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI \>= 30)

Exclusion Criteria:

* Medication regimen that represents medical contraindication to sibutramine
* Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
* Pregnancy
Genetic Testing for All Breast Cancer Patients (GET FACTS)

This study is designed to determine the impact of a novel genetic counseling method on surgical decisions in individuals with newly diagnosed breast cancer

This research study involves an expedited and surgery-specific form of genetic counseling.

The names of the study methods involved in this trial are/is:

* Quantitative genetic counseling (discussion is guided by tables and graphs)
* Standard genetic counseling

* The research study procedures include screening for eligibility and study interventions including evaluations and follow up visits
* After receiving genetic testing, participants will be placed into one of two counseling methodology groups:

  * Standard genetic counseling: Standard of care discussion
  * Quantitative genetic counseling: Discussion is guided by tables and graphs.
* Participants will be on the research study for up to six months, with an optional extension to two years.
* It is expected that about 450 people will participate.
* This research study is a Feasibility Study, which is the first-time investigators are examining this form of genetic counseling.
* This is a randomized study. Randomization means being put into a group by chance. It is like flipping a coin. Neither the participant nor the Investigator will choose the group the participant is assigned to.

Eligibility Criteria:
Inclusion Criteria

* Patients with a new breast cancer diagnosis (invasive or in-situ) considering genetic testing
* Patients with good understanding of written and spoken English
* Patients with apparent cognitive capacity to make surgical decisions for themselves
* Patients who are medically cleared for surgery
* Patients must be at least age 18 but under 79

Exclusion Criteria

* Previous breast cancer diagnosis (invasive or DCIS)
* Metastatic breast cancer
* Patients who have received prior broad-based panel testing (prior BRCA1/2 testing with negative results allowed)
* Bilateral breast cancer
* Known medical or surgical contraindication to contralateral mastectomy
* Hematologic malignancy necessitating skin biopsy/fibroblast culture for germline genetic testing malignancy other than cervical cis or basal or squamous cell skin cancers.