cyrilzakka/clinical-trials huggingface dataset:
Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance in 6-8 Year Old School Children

Six week RCT intervention on the effects of phospholipid containing milk drink vs. placebo milk drink on cognitive performance in 6-8 year old school children.

A randomised, double blind, placebo controlled study with parallel groups investigating a 6 week intervention in 6-8 year old school children of phospholipid containing milk drink vs. placebo milk drink. Participants were familiarised with the test battery and IQ (Wechsler abbreviated scale of intelligence) and colour blindness (Ishihara test) measurements were taken prior to the intervention. Milk drink taste testing and milk preference selection was also carried out prior to the intervention. The test battery was administered at baseline (week 0), midpoint (week 3) and endpoint (week 6), and the milk intervention was given Monday - Friday at school shortly before their mid-morning break over a 6 week period. This study design, including both the test days and morning milk supplementation, was intended to emulate the children's normal routine as far as possible. The milk drink was a supplement to the children's usual diet.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 6-8 years.
* Willingness to consume milk drinks during the study determined by a score of \>5 on a taste testing Likert scale for at least one flavour of the milk drinks.
* Ability to follow verbal and simple written instructions in English.
* Normal vision, with appropriate corrective lenses if required.
* Ability to understand cognitive testing instructions and responding requirements.

Exclusion Criteria:

* Poor general health.
* Colour blindness.
* Behavioural difficulties or attention disorders (e.g. Attention Deficit Hyperactivity Disorder).
* Learning disabilities that interfere with the ability to understand written or verbal communications.
* Inability to understand the objective of the cognitive tests, or carry out the tests.
* Any food allergies or intolerances (e.g. lactose intolerance).
* Acute illness, or feelings of unwell, within the week prior to testing.
* Current administration of any psychotropic medication or supplementation in the month prior to testing, or during testing.
* Hearing impairment that precludes the ability to follow verbal instructions.
* Children already receiving milk at school unless parents are willing to substitute current milk with the study milk.
Effects of Pilates Exercises on Hearing Impairment Children

This study will determine the effects of Pilates exercises on static and dynamic balance in children with hearing impairment. Children with hearing impairment often encounter challenges in their motor development, including difficulties in maintaining balance and mobility. Impaired balance and limited mobility can significantly impact their overall physical well-being and functional independence. Therefore, it becomes crucial to explore effective interventions that can address these specific needs and promote improve balance and mobility in this population. Pilates, a mind-body exercise approach, has gained recognition for its potential benefits in enhancing balance, flexibility, and core strength in various populations.

A Randomized clinical trial will be conducted through convenient sampling. Subjects will randomly be allocated into two groups experimental group will receive balance exercises in addition to Pilate exercise while control group will receive will receive conventional therapy for strength, balance and postural stability. The duration of the treatment will be 10 weeks for 3 days a week for 45 minutes. Pediatric Balance Scale, Pediatric Reach Test (Pediatric Functional Reach Test) and Timed Up and Go Test will be used as outcome measure. Data will be analyzed on SPSS version 29.0; normality of the data will be checked and tests will be applied according to the normality of the data either it will be parametric test or non-parametric based on the normality.

Eligibility Criteria:
Inclusion Criteria.

* Age between 5 to10 years
* Having greater than 24 score of mini mental state examination (MMSE-C) for children
* Children diagnosed with congenital sensorIneural hearing impairment
* Having a hearing loss\>75dB
* Able to follow instructions

Exclusion Criteria:

* Presence of any visual, physical or mental disability in addition to hearing loss, or any orthopedic or neurological problem that may affect balance
* Severe hearing losses were greater than75dB
* Parents or patient refuse to take part
* Have participated in other therapy programs during our intervention
The Effect of Simple Gymnastics Training for Parkinson's Patients in the Community

The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

In the early stages of Parkinson's disease, many patients do not seek medical attention. The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Eligibility Criteria:
Inclusion Criteria:

* Age \>60 years.
* Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.

Exclusion Criteria:

* Complicated with cognitive impairment or consciousness dysfunction.
* Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
* Complicated with severe liver and kidney failure, tumors, or hematological disorders.:
Clinical Use of Andante SmartStep System in Gait Rehabilitation

The purpose of this study is to evaluate the effectiveness of the biofeedback gait training device in improving load bearing over an operated limb, during post-operative gait training therapy. The effectiveness of the device will also be tested in self-training at home.

To evaluate the effectiveness of the biofeedback gait training device as a biofeedback training therapeutic tool in improving body-weight bearing over the affected lower limb, quality of gait, level of ambulation and physical independence during rehabilitation, in patients after orthopedic procedures during gait therapy training, and as a biofeedback device for self-training at home.

Eligibility Criteria:
Inclusion Criteria:

* Rehabilitation after operation
* Patient is allowed full weight bearing
* Patient is motivated and able to communicate and understands orders
* Patient is able to walk 10 meters
* Patient filled out agreement and consent form

Exclusion Criteria:

* Activity limitation due to medical disorder, medications, or emotional status.
* Pain markedly obstructs gait ability
* Documented peripheral neuropathy
* Functional limitation prior to the current condition
* Premorbid, ongoing major depression or psychosis
* Multiple/pathological fractures
* Serious early complications
* Terminally ill patients
* Pregnant women
* Participation in current or recent (within 60 days prior to surgery) clinical trial
Envarsus Neurotoxicity Burden in Liver Transplant Patients

This study will compare neurologic side effects associated with two immunosuppressant medications used in liver transplant patients. The standard therapy of twice daily immediate release Tacrolimus will be compared to Envarsus once daily. We hypothesize that Envarsus will show a lower rate of neurologic side effects than immediate release tacrolimus.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult (≥18 years old) with a history of liver or liver/kidney transplant within the first 6 months of transplant.
2. Patients must be capable of understanding the purposes and risks of the study and have the ability to give written informed consent and be willing to participate and comply with the study.

Exclusion Criteria:

1. Patients will be excluded if they are pregnant or nursing females or males with a pregnant female partner
2. HIV positive (HIV ab +)
3. Unable to tolerate oral medications
4. Use of another investigational product within thirty days prior to receiving study medication
5. Moderate acute cellular rejection (RAI ≥ 5) within the past month
6. A condition that is known to cause tremor such as essential tremor, Parkinson disease, or enhanced physiologic tremor.
7. Patients taking medications known to induce tremors or dopamine blocking agents
8. A condition or disorder that, in the opinion of the investigator, may adversely affect the outcome of the study or the safety of the subject
Functional Endoscopic Sinus Surgery Study

The aim of this study is to evaluate the effect of the addition of epinephrine to bilateral real time ultrasound guided pterygopalatine ganglion blocks on intra-operative bleeding and blood loss during functional endoscopic sinus surgery (FESS).

FESS is the treatment of choice in patients with medically refractory chronic rhinosinusitis and chronic polypous rhinosinusitis. This surgery relies on minimal surgical site bleeding to be performed efficiently and safely. Hemorrhage during FESS decreases visibility of the surgical field and this increases the risk of vascular, orbital and intracranial complications as well as procedural failure. Thus the importance of minimizing surgical bleeding in this procedure. The maxillary artery is the primary blood supply for the sinuses and midface. Conceptually the application of epinephrine into the pterygopalatine fossa onto the maxillary artery with the block should result in constriction of this artery and subsequently, less bleeding from the surgical site. This randomized, double-blinded, controlled pilot study will investigate the utility of addition of epinephrine to bilateral pterygopalatine ganglion blocks performed under ultrasound guidance in minimizing surgical site bleeding and overall blood loss and the potential for shortening the surgical time.

Eligibility Criteria:
Inclusion Criteria:

1. Patient presenting for bilateral FESS
2. Adult patients (\>18 and \< 90 years old)
3. Patient consents to participate
4. No underlying chronic pain condition
5. No underlying bleeding diathesis

Exclusion Criteria:

1. Patient refuses to consent
2. Patient requires revision or unilateral surgery
3. Patient requires surgery in addition to FESS
4. Age younger than 18 or older than 90 years
5. Any underlying chronic pain condition
6. History of bleeding diathesis
7. Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for block placement.
8. Presence of any other factor which, at the discretion of any member of the study team, makes the patient a poor candidate for research participation.
9. Vulnerable patient population
OFSEP High Definition Cohort

For neurologists and patients, it appears that one major unmet need, beside of course a cure to multiple sclerosis (MS), is to better appreciate the causal factors of disease progression, and even to obtain reliable predictive tools that could apply on the individual level and at different key moments in the disease course.

The overarching objective of the OFSEP-HD cohort is to determine prognostic factors of the evolution of disability in MS in real life, looking at disease characteristics, care practices potentially modifying the evolution of the disease since MS clinical onset and along specific post-onset landmarks. This general framework leads to study 3 specific research objectives:

1. To identify determinants (socio-demographic characteristics, clinical characteristics, health related quality of life (QoL), changes in classification, and biomarkers) for the progression of MS disease and its consequences;
2. To study the effectiveness of treatments in real life;
3. To merge both determinants and treatments for creating patient-centered prognostic tools for identifying specific subgroups of patients and helping making decision to start, maintain or adapt care management.

To achieve these objectives, the OFSEP (The French multiple sclerosis registry) infrastructure, managed under a quality insurance system, offers a unique opportunity for the first time in France to create a large cohort of MS cases, providing high-definition and sequential multimodal data.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple sclerosis according to the most recent criteria at entry into the HD cohort
* Followed in one MS Clinical Reference Centre (CRC SEP)
* Newly diagnosed after the study start or
* If MS onset occurred before study start, regular follow-up in a CRC SEP
* Irreversible disability ≤ 7.0 (permanent use of a wheelchair) on EDSS at inclusion in the study

Non-inclusion Criteria:

* Inability to answer questionnaires
* Pregnant women at the time of inclusion
A Study of AK131 in Patients With Advanced Solid Tumors

This is a phase Ia/Ib study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK131 in advanced solid tumor patients


Eligibility Criteria:
Inclusion Criteria:

1. Written and signed informed consent.
2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
3. Life expectancy ≥3 months.
4. Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.
5. Subject must have at least one measurable lesion according to RECIST Version1.1.
6. Adequate organ function.
7. Female subjects of childbearing potential and male subjects with female partners of childbearing potential must agree to use effective barrier methods of contraception during the study and for 120 days after last dose of study drug.

Exclusion Criteria:

1. Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers.
2. Being involved in another clinical study, except for observational clinical studies or follow-up period of interventional studies.
3. Receipt of any anti-CD73 treatment.
4. Anticancer therapy within 4 weeks prior to the first dose of investigational product.
5. Experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
6. Subjects with spinal cord compression or active brain metastases, except for subjects with untreated and asymptomatic brain metastases or with stable brain metastases after treatment.
7. Subjects with pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
8. Subjects whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the study.
9. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1.
10. Patients with clinically significant cardio-cerebrovascular disease.
11. Active autoimmune diseases or history of autoimmune diseases that may relapse.
12. History of interstitial lung disease or noninfectious pneumonitis.
13. Major surgery, trauma,unhealed wound, ulcer or fracture within 4 weeks prior to first dose of investigational product.
14. Any condition that required systemic treatment with corticosteroids or other immunosuppressive agents within 14 days prior to the first dose of investigational product.
15. Receipt of live attenuated vaccines within 4 weeks prior to the first dose of investigational product.
16. Known allergy or reaction to any component of the AK131 formulation.
17. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.
18. Any other conditions that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.
The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age

The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts exclusively on children below 12 months of age; children who have reached 12 months of age are no longer entitled to vaccines through the EPI program. This has affected the measles vaccination coverage, approx. 30% of the children in the rural area do not receive measles vaccine (MV).

Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on survival, reducing mortality by approximately 50% - far more than can be explained by prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on survival, and the current policy may have important consequences for overall child mortality.

To test the implications of the current policy of only vaccinating children below 12 months of age, the investigators will conduct a cluster randomized trial, in which children will receive their vaccines according to the current national EPI policy (National policy) or receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy).

The investigators hypothesise that among children enrolled after 12 months of age, mortality is 50% lower in children randomised to receive MV compared with children randomised to follow the national policy and not receive MV.


Eligibility Criteria:
Inclusion Criteria:

* Age 9-35 months, not yet received routine measles vaccination, resident in study area

Exclusion Criteria:

* To ill to be vaccinated (according to local practice)
Effects of Paclitaxel on Intimal Hyperplasia

This is a single, one time, limited dose infusion of Paclitaxel, that will potentially prevent recurrent stenosis secondary to intimal hyperplasia when compared to the control group at 10 months.

The investigators study consists of enrolling subjects that are already scheduled to have the blood vessels in their legs re-opened. The entire study is considered standard of care, except the administration of Paclitaxel. Subjects will be consented prior to any study related procedures and prior to procedure. Subjects that meet inclusion/exclusion and the infusion of Paclitaxel has been given, will then be enrolled in the study. After the plaque area has been treated with either angioplasty (inflation of a balloon compacting it against the artery wall), stent (a wire mesh tube that presses the plaque against the artery wall and opens the artery), and/or atherectomy(removal of plaque from the artery), Dr Kelly, Dr. Schultz, Dr, Laurich, or Dr. Santos will then use an infusion balloon (a balloon with an outer layer that has holes that allows a medication to be given) to administer the Paclitaxel. Every time the infusion balloon is blown up, a single dose of medication (Paclitaxel) will be applied to the target lesion. This will be repeated until all of the target lesions have been treated or a maximum dose of 10 mg of Paclitaxel has been given. All persons enrolled in this study will be treated with Paclitaxel. Subjects are expected to attend all follow up visits. These visits would occur even if the subject were not on the trial. Ankle-brachial index (ABI) (done by measuring blood pressure at the ankle and in the arm while a person is at rest. This test indicates if leg blockages are present) and Duplexes (An ultrasound that measures blood flow rates through the vessels. This test will indicate if leg blockages are present) will be done at the follow up visits. Both of these tests and all follow up visits are considered standard of care and will be charged to the subject or subject's insurance.

Eligibility Criteria:
Inclusion Criteria:

* ability to provide informed consent
* age 18-90 years old
* Rutherford 1-6
* occlusion or stenosis in the infrainguinal vessels

Exclusion Criteria:

* inability to pass the guide wire across the lesion
* pregnant or lactating women
* specific limb has not been previously treated with endovascular intervention
Vascular Inflammation and Cholesterol Lowering Therapy

This study aim to detect change in vascular inflammation following intense lipid lowering therapy


Eligibility Criteria:
Inclusion Criteria:

* treatment with PCSK-9 inhibitors

Exclusion Criteria:

* Infection Pregnancy Severe claustrophobia Weight \>140 kg
Fecal Microbiota Transplant National Registry

A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness. Neonates will not be enrolled at any site for this study. The study data will derive from patient and donors past and present medical records, research records, and records about phone calls made as part of this research. The patient data will also be used from the records on visits.


Eligibility Criteria:
Recipient Inclusion Criteria :

* Ability to give informed consent
* Receiving FMT or other gut-related microbiota product within 90 days after providing consent
* Access to internet and/or telephone

Donor Inclusion Criteria:

* Ability to give informed consent
* Providing stool sample for FMT

Exclusion Criteria:

* Incarceration