cyrilzakka/clinical-trials huggingface dataset:
Mode of Sedation During Endovascular Treatment of Vertebrobasilar Stroke

Optimal anesthetic mode is not established for patients with vertebrobasilar stroke undergoing endovascular treatment. We want to investigate whether a procedural sedation mode approach is feasible compared to general anesthesia

Endovascular treatment has become standard of care for many patients with acute ischemic strokes due to large vessel occlusions and is recommended by several national and international guidelines. Several studies have shown that anesthetic modality during endovascular treatment might affect the functional outcome. While much evidence has been generated for ischemic stroke of the anterior circulation, only a few studies have investigated anesthetic modalities in strokes with occlusions of the vertebrobasilar arteries. The majority of patients with vertebrobasilar occlusion strokes undergo endovascular procedure in general anesthesia and not a less burdensome sedation despite the lack of evidence for that approach. A few retrospective studies and a small single-center prospective randomized trial investigating this topic indicate that primary procedural sedation might be a feasible anesthetic approach. Here we aim to provide further high-level evidence by conducting a prospective randomized clinical trial with a PROBE (parallel-group, open-label randomized controlled with blinded endpoint evaluation) design for this research question.

Eligibility Criteria:
Inclusion Criteria:

1. Decision for thrombectomy according to local protocol for acute recanalizing stroke treatment
2. Age 18 years or older, either sex
3. National Institutes of Health Stroke Scale (NIHSS) ≥ 4
4. Acute ischemic stroke in the posterior circulation with isolated or combined occlusion of vertebral artery (VA) and basilar artery (BA)
5. Informed consent by the patient him-/herself or his/her legal representative obtainable within 72 h of treatment (deferred consenting procedure)

Exclusion Criteria:

1. Intracerebral hemorrhage
2. Coma on admission (Glasgow Coma Scale ≤ 8)
3. Severe respiratory instability, loss of airway protective reflexes or vomiting on admission, where primary intubation and general anesthesia is deemed necessary
4. Intubated state before randomization
5. Severe hemodynamic instability (e.g. due to decompensated cardiac insufficiency)
To Examine the Lung When People With Diabetes Take an Inhaled Form of Insulin, Compared to Subcutaneous Insulin.

To examine the lung when people with diabetes take an inhaled form of insulin, compared to subcutaneous insulin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Normal lung function

Exclusion Criteria:

* Smokers
Effect of Exercise-education Program PERMANENTO in Late Life

The general aim of the present study is to create and empirically evaluate (RCT trial) an online education and exercise program (called PERMANENTO) to help older adults to understand the wider consequences of being active and offer them easy to follow exercise program inspired by developmental kinesiology.

There is no doubt about the importance of a physical activity at a later age, yet it is often missing in the lives of seniors and the current epidemiological situation deepens this deficit even further. It is known that insufficient physical activity has a major effect on the decline of functional fitness components, premature development of sarcopenia or frailty syndrome, threatening self-sufficiency, health and consequently quality of life. This is associated with an increased burden on the health care system and related social services, with implications for public budgets. The aim of this project is to eliminate the onset or premature manifestation of negative aspects of aging by prevention. The content is to research a unique intervention inspired by the principles of developmental kinesiology with a presumed positive effect on the health status and the development of a comprehensive exercise and educational program for older adults. The main planned result of the project is a methodological manual and a web application containing education and exercise program for both older adults as well healthcare professionals.

The project responds to the priorities of the Applied Health Research Program for the years 2020-2026 and its focus contributes to a long-term solution of the population aging issue. With regard to demographic change, health and social care systems will be unsustainable without the adoption of preventive measures by seniors themselves. Exercise-educational intervention can lead to lasting changes and can help seniors to actively and responsibly participate in the course of their own aging. Main objective: to reduce negative health related aspects of aging, resp. their premature manifestation, by a preventive exercise-educational program. Sub-objectives: - to develop a specifically targeted exercise-educational program; - to demonstrate effectiveness of the program on health and social related indicators; - to assess acceptability, sustainability and other personal contexts - to create a methodological manual and a web platform for home-dwelling as well as institutionalized older adults containing complex information for independent exercise (how, as well as why).

Eligibility Criteria:
Inclusion Criteria:

* permanent residency in Prague
* being at least 70 years of age or older
* living independently at home

Exclusion Criteria:

* significant mobility limitation
* any health condition preventing from physical activity
A Clinical Trial Evaluating TG4050 in Head and Neck Cancer

This is a multicenter, open-label, two arms, randomized, phase I/II study evaluating the safety and tolerability as well as some activity parameters of TG4050 in patients with squamous cell carcinoma of the head and neck (SCCHN).


Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Newly diagnosed stage III or IV, amenable to surgery (AJCC 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
3. Female or male patients, aged at least 18 years
4. Patients in Complete Response after treatment of their primary tumor.
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
6. Adequate hematological, hepatic and renal functions

Exclusion Criteria:

1. Patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknown primary, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histologies.
2. Prior exposure to anti-cancer vaccines and any antibody targeting T-cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA4 antibodies.
3. Other active malignancy requiring concurrent systemic intervention.
4. Patients with previous malignancies other than the target malignancy to be investigated in this trial
5. Known history of positive testing for Human Immunodeficiency Virus (HIV) or known Acquired Immune Deficiency Syndrome (AIDS)
6. Clinical or laboratory history or evidence of Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) indicating acute or chronic infection
7. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\> 10 mIU/mL)
8. Treatment with another investigational agent since the beginning of the screening period
9. Uncontrolled intercurrent illness
Prospective Study of Scheuermann's Kyphosis

The purpose of this study to determine the radiographic and clinical outcomes of spinal deformity surgical treatment in patients with Scheuermann's Kyphosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \< 21 years
* Male or female
* Diagnosis of classical Scheuermann's Kyphosis (3 successive vertebrae wedged 5 degrees or more, +/- end plate deformities) or idiopathic structural Kyphosis (rigid structural kyphosis without classic Scheuermann's Kyphosis findings).
* for which surgical treatment is recommended to prevent progression of the curvature or to correct trunk deformity (unacceptable cosmesis) - any deformity magnitude.

OR

* for which surgical treatment is not being undertaken (and alternate treatment, i.e. bracing, or observation) is being pursued for any curve magnitude of clinical concerns of Scheuermann's Kyphosis.
* Inclusion Criteria for Anterior Release (for those surgeons performing anterior release surgery): Deformity magnitude = any degree and any other criteria defined by the individual surgeon.
* Posterior disc herniation is not an exclusion criteria from being in the study, only from being in the Posterior surgery group - these patients will be defaulted to Ant/Post Surgery.
* Only patients that have had a pre-op MRI performed as a part of their routine care, should be included in this study.

Exclusion Criteria:

* Previous operated Kyphosis, Scoliosis or Spondylolisthesis
* Neuromuscular co-morbidity
* Post laminectomy kyphosis
The Effect of Relaxation Program on Coping With Stress and Anxiety Levels of Caregivers of Children With Cancer.

This research will be carried out to determine the effect of the relaxation program applied to the caregivers of children followed by the diagnosis of cancer on the levels of caregivers' anxiety and coping with stress. The research will be conducted in a single-blind parallel-group randomized controlled trial design. A relaxation program including progressive muscle relaxation exercises will be applied to caregivers. The application will be carried out by sending muscle relaxation videos and videos for relaxation to mothers. The relaxation program is planned to last approximately 6 weeks

In this study, a relaxation program will be applied to mothers who have a child followed up with a cancer diagnosis. The relaxation program will include progressive muscle relaxation exercises and videos for relaxation. Initial applications will be implemented with caregivers. The relaxation program is planned to last 6 weeks. The program is planned to last 8 weeks in total, with pre-test and post-test applications. Caregivers will then be asked to perform the treatments each week. Coping with Stress and State-Trait Anxiety Scale will be used at the beginning and end of the program.

Eligibility Criteria:
Inclusion criteria

* The child has received cancer treatment for at least two months,
* Those who have internet access on their smartphone or computer
* Those who can continue the work for six weeks (doing progressive relaxation exercises at least 2 times a week)

Exclusion Criteria:

* Those whose children/caregivers are in the terminal period,
* Those whose child/caregiver has not received chemotherapy treatment,
* Those who take medication for anxiety or use one of the complementary medicine approaches.
Early Apical Release vs Classic Holmium Laser Enucleation of the Prostate: Randomized Controlled Trial Comparing Post-Operative Incontinence Rates and Surgical Outcomes

To determine if early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia, reduces post-operative urinary incontinence compared to classic HoLEP.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older
* Patients must present to clinic with a diagnosis of benign prostatic hyperplasia
* Patients must be scheduled to undergo a holmium laser enucleation of the prostate

Exclusion Criteria:

* Patients with previous surgical management of BPH
* Patients with prostate biopsy revealing high risk prostate cancer
* Patients with a concomitant neurogenic bladder diagnosis (SCI, Parkinson, MS, cerebral palsy)
Phase 1 Pilot Study of 4-MP to Treat Stargardt Macular Dystrophy

The purpose of this study is to investigate whether taking 4-methylpyrazole (4-MP, fomepizole, Antizol™) inhibits dark adaptation of the eye. In other words, we are testing if 4-MP slows the processing of vitamin A derivatives in the eye. By slowing down these processes, individuals with Stargardt disease may have better chances of saving their remaining vision. 4-MP has been shown to slow dark adaptation in animals, and is FDA approved for human use to treat individuals with methanol or ethylene glycol (antifreeze) poisoning by shutting down the body's ability to process alcohols. This medication has an excellent safety profile and has been reported to have no short-term or long-term side effects, as long as patients refrain from any alcohol while the medication is in the body. A single dose of 4-MP remains in the body for about 12 hours, and therefore, it may inhibit dark adaptation of your eyes for up to 12 hours. Studying the effects of 4-MP may lead to effective medical treatment to save Stargardt patients' vision, and may also have similar effects in other macular degenerative diseases.


Eligibility Criteria:
Inclusion Criteria:

* All nonpregnant, nonlactating adults with normal vision in both eyes

Exclusion Criteria:

* Previous ocular pathologies
Radicle Rest 2: A Study of Health and Wellness Products on Sleep and Health Outcomes

A randomized, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other health outcomes.

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Eligible participants will (1) endorse a desire for improved sleep, (2) indicate an interest in taking a health and wellness product to potentially help their sleep, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded.

Self-reported data are collected electronically from eligible participants over 7 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility Criteria:
Inclusion Criteria:

* Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities
* Resides in the United States
* Endorses better sleep as a primary desire
* Selects sleep, looking to improve their sleep, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product
* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion Criteria:

* Reports being pregnant, trying to become pregnant, or breastfeeding
* Unable to provide a valid US shipping address
* The calculated validated health survey (PRO) measurement result is less than mild severity/impairment
* Reports a diagnosis of liver or kidney disease
* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)
* Unable to read and understand English
* Reports current enrollment in a clinical trial
* Lack of reliable daily access to the internet
* Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection
* Reports taking medications with a known moderate or severe interaction with any of the active ingredients studied: anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or monoamine oxidase inhibitors (MAOIs)
* Reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: New York Heart Association (NYHA) Class III or IV congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias
Hormone Replacement Trial Against ALzheimers' Disease

The influence of postmenopausal hormone treatment on dementia is not clear. Dysfunctions in the metabolism of amyloid in the disease of Alzheimer result in an elevated presence of degradation products in cerebrospinal fluid.

The degradation products in blood will be analysed during the trial, to get better insight in menopause and the start of hormonal therapy.

Postmenopausal women with and without history of breast cancer will be recruited for the trial.


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women
* 40 - 65 years

Exclusion Criteria:

* Longer than 10 years in menopause
* thyroid dysfunction
* hypertension
* medical history of psychiatric comorbidity
* Alcohol and/or drug abuse
* medical history of neurologic symptoms with cognitive symptoms
N-Acetylcysteine vs Placebo as Adjunctive Treatment in Pediatric Leukemia

The goal of this clinical trial is to analyze the effect of N-Acetylcysteine administration towards blood oxidant level, transaminase enzyme, and bilirubin level in ALL children who undergo induction phase of chemotherapy. The main question it aims to answer is whether N-Acetylcysteine can decrease oxidative stress level and reduce hepatotoxicity complication.

Participants will be evaluated for MDA level, transaminase enzymes and bilirubin level before, during, and after the chemotherapy. Participants will be given capsules containing 600mg of N-Acetylcysteine as adjunctive treatment during the 6 weeks induction phase of chemotherapy.

Researchers will compare the lab results to the placebo group to see if there is any significant difference in the results.

The current study has been designed as a randomized single-blind placebo-controlled clinical trial. Sample size calculation for the study was 18 newly diagnosed ALL children in each group using the numerical unpaired two groups data analysis formula. Subjects were recruited from newly diagnosed children with ALL and will start the induction phase of chemotherapy both in hospital ward and outpatient clinic in the Child Health Department at Cipto Mangunkusumo Hospital from August to December 2020. Subjects' parents received an explanation about the study, including the objective and benefits of the study, and also the procedure which will be held. Parents were then asked about the willingness to join the study and signed the form.

Subjects were randomized consecutively and distributed into two groups. Randomization was done by a third person to decide the distribution of the subjects based on the serial number of randomization. Subjects in treatment group will be given capsules containing 600 mg of NAC and subjects in the control group will be given capsules containing placebo (lactose) as the adjunctive treatment during the 6 week induction phase of chemotherapy. Both of the medicines were prepared by the Installation of Pharmacy in Cipto Mangunkusumo National Hospital with the same type and same color of capsules. NAC will be administered during the induction phase of chemotherapy starting in the first week until 6 weeks. This study will analyze change of MDA levels, transaminase enzyme levels, and bilirubin levels before and after the 6th week of the induction phase of chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed ALL-Standard Risk children who will undergo the induction phase of chemotherapy from 1st week until 6th week
* parents agreed to participate in the study and signed the informed consent

Exclusion Criteria:

* subjects with allergy or contraindicated to consuming N-acetylcysteine
* subjects with liver dysfunction based on clinical and laboratory tests diagnosed before joining the study
* subjects who already consume other antioxidants (vitamin A, vitamin C, and vitamin E).
Effects of Red Bull® on the Effects of Training and Haemodynamic Parameters

Background:

The consumption of Energy Drinks (EDs) can acutely lead to negative side effects, such as raised blood pressure and impaired endothelial function. Nevertheless, they are sold worldwide and are often consumed before physical activity (PA). In contrast to the blood pressure elevating effect of EDs, PA leads to a reduction of blood pressure. The effect of ED consumption on blood pressure response during and after endurance training is currently unresolved.

Methods:

A total of 23 participants (eleven men, twelve women) were evaluated in the intervention study with a blinded Cross-Over Design. They consumed on two different days either 355 ml Red Bull (RB) or 355 ml Placebo (Pla) in randomised order. The peripheral (PBP) and central blood pressure (CBP) were measured before, during and after a 30-minute aerobic endurance training, by the Schiller BR-102 plus PWA device.

Background:

The consumption of Energy Drinks (EDs) can acutely lead to negative side effects, such as raised blood pressure and impaired endothelial function. Nevertheless, they are sold worldwide and are often consumed before physical activity (PA). In contrast to the blood pressure elevating effect of EDs, PA leads to a reduction of blood pressure. The effect of ED consumption on blood pressure response during and after endurance training is currently unresolved.

Methods:

A total of 23 participants (eleven men, twelve women) were evaluated in the intervention study with a blinded Cross-Over Design. They consumed on two different days either 355 ml Red Bull (RB) or 355 ml Placebo (Pla) in randomised order. The peripheral (PBP) and central blood pressure (CBP) were measured before, during and after a 30-minute aerobic endurance training, by the Schiller BR-102 plus PWA device.

Eligibility Criteria:
Inclusion Criteria:

* No known cardiovascular diseases such as arterial hypertension and diabetes mellitus.
* No ophthalmological diseases such as glaucoma or macular degeneration.
* No regular medication
* No vasodilator abuse for 24 h before the respective intervention (e.g. smoking, use of stimulants, β-blockers).
* No pregnancy (anamnestic)
Effect of Watermelon on Gut and Cardiometabolic Health

The goal of this clinical trial is to evaluate the effect of daily fresh watermelon consumption for 6-weeks on gut health, including microbiome diversity, gut barrier and immune function in young adults with overweight and obesity. The main questions it aims to answer are:

1. Will consuming fresh watermelon daily for 6-weeks will improve intestinal barrier health and increase microbiome diversity such as an increased population of beneficial 'probiotic' bacteria when compared to control participants consuming a low-fat snack?
2. Will consuming fresh watermelon daily for six-weeks will improve other health measures, including body-composition, blood pressure, blood vessel function, blood lipid profiles, and measures of inflammation, as compared to control participants consuming a low-fat snack for the same time period?


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 30 years old
* Ability to speak and read in English
* Overweight or Obese Class 1 and 2 (BMI ≥ 25 - 39.9 kg/m2)

Exclusion Criteria:

* Intake of antibiotics in the last 3 months
* Intake of pre/pro/postbiotics in the last 3 months
* Current or past (within the last 6 months) user of tobacco, marijuana, or E-cigarette products
* Cardiovascular disease (will not exclude for hypertension), gastrointestinal disease (ulcerative colitis, celiac, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C greater than 9%).
* Food allergy to study foods
* Any allergy to melon
* Any allergy to the isocaloric snack (gluten)
* Regular consumption of watermelon greater than 2 servings / week
* Current heavy alcohol use (≥ 15 drinks / week for men, ≥ 8 drinks / week for women
* Class 3 Obesity (BMI \&amp;amp;gt; 40 kg/m2)
* Current user of Citrulline, Arginine, Nitric Oxide or other supplements known to affect nitric oxide synthesis (beet root juice or any beet supplement, Pycnogenol / Pine bark extract)
* Known to be currently pregnant (self-disclosed)