cyrilzakka/clinical-trials huggingface dataset:
Computer-based Cognitive Training for Parkinson Disease

Parkinson's Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities.

The primary study hypothesis is that computer-based training aimed at improving executive function will have a beneficial effect on gait functions.

Parkinson Disease (PD) is a neurodegenerative, progressive illness. It is a multi-system disease that influences not only the motor but also the cognitive and autonomic systems. The main cognitive impairment in individuals with PD is found in executive function (EF). EF is defined as a set of cognitive skills necessary for planning, monitoring and executing sequences of complex activities. Previous studies have revealed some relation between cognitive states and physical functions in healthy adults. Few studies have examined the effect of computer-based cognitive training on various populations. These studies showed a positive emotional-cognitive effect in those populations. This type of intervention plan was also applied to PD patients. However, there are no reports on the effect of intentional cognitive training on gait functions. The purpose of the study is to assess whether cognitive training, designed to improve EF ability, can also improve gait function in PD patients.

Eligibility Criteria:
Inclusion Criteria:

1. Idiopathic PD.
2. Aged 50-80, living in north region of Israel.
3. Receive regular medications for PD.
4. Not suffering from irregular cognitive disturbance or MMSE\<25.
5. Measured 1-3 on the Hoehn \& Yahr scale.
6. Have access to a computer and the ability to operate it.

Exclusion Criteria:

1. Brain operation, including DBS transplant.
2. History of orthopedic problems that can impair gait (hip/knee fractures and back problems).
3. Orthopedic operation on lower limbs performed no later than six months prior to the beginning of the study.
4. Unbalanced general health: uncontrolled diabetes or blood pressure, etc.
5. Inability to walk independently.
6. Immunodeficiency diseases, active cancer, ischemic diseases.
7. Vision impairment, partial/full blindness.
8. Having participated in similar research or cognitive assessment during the previous year.
9. Have received cognitive or gait training under physical therapy or other programs.
Screening for COVID-19 in Teachers, Childcare Educators, Pupils and Preschoolers

The main objectives of this study are

1. to establish the prevalence of SARS-CoV-2 in schools and kindergartens in the State of Mecklenburg-Vorpommern in autumn and winter 2020/2021
2. to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in teachers and childcare educators over time

Detailed Description:

This study aims to collect information on teachers and childcare educators as well as on pupils and preschoolers in the State of Mecklenburg-Vorpommern

Over a 5 month period, 5 study visits per participant are planned. At each visit, nasal/throat swabs (for PCR testing) will be collected and participants will be asked to fill in a questionnaire (asking for SARS-CoV-2 risk factors, perceived risk, and impact of the pandemic on their quality of life). In adults, additional blood samples (for SARS-CoV-2 antibody testing) will be collected at the first and the last study visit. This will help to gain a better understanding of viral load and antibody development over time.

The remaining blood samples will be stored in a repository for future research.

The study is part of a modular SARS-CoV-2-research programme of the University Medicine Greifswald.

Eligibility Criteria:
Inclusion criteria:

* See cohort descriptions
* Willing to have blood samples stored for future research

Exclusion criteria:

- None
Extracellular Matrix Marker of Arrhythmia Risk (EMMA)

Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular tachycardia or fibrillation in patients who have implantable cardioverter defibrillator devices.

Sudden cardiac death (SCD) is responsible for 300,000-450,000 deaths per year in the United States. While it is well known that patients with both ischemic and non-ischemic cardiomyopathy (ICM, NICM) are at increased risk for SCD, there is little beyond ejection fraction which has proven useful as a noninvasive predictor to risk stratify these patients.

Myocardial scar has been validated as an arrhythmic substrate in ischemic populations; the majority of successful ablations for lethal ventricular arrhythmias are performed on tissues in peri-infarct regions. Scar provides an anatomic electrical boundary where peri-infarct zones may lead to areas of slow conduction due to the disruption of inter-myocyte electrical conduction.

Myocardial scar is a less organized collagen deposition which disrupts the typical cardiac extracellular matrix. The collagen matrix provides mechanical support to the myocardium dictating ventricular shape, size and stiffness. While typically relatively dormant, the fibrillar collagen matrix reflects a dynamic relationship between collagen synthesis mediated by fibroblasts and collagen degradation performed by matrix metalloproteinases (MMP).

A marker for scar burden or a marker which could assess a patient's predilection to form scar after either an ischemic or non-ischemic insult may be useful in further risk stratifying this population. Since MMP levels may fluctuate in the course of ischemic or nonischemic injury a static promoter sequence which confers a higher level of MMP expression to an ischemic or nonischemic insult may prove to be a reliable marker. Functional polymorphisms of the MMP-9 gene promoters have been shown in multivariate analysis to be an independent predictor of cardiac mortality regardless of the mechanism of heart failure.

Eligibility Criteria:
Inclusion Criteria:

* LVEF of ≤ 35% measured within 6 months of ICD implantation
* NYHA class II-IV at the time of ICD implantation
* ICD implantation at least 1 year prior to enrollment

Exclusion Criteria:

* Status post heart transplant
* Known malignancy in the past 2 years.
* Recent procedure, intervention or surgery within the past 90 days
* Acute MI, CABG, or PTCA/stent within the past 2 months.
* Active rheumatoid arthritis or pulmonary or hepatic fibrosis.
* Taking chronic steroid therapy for a medical condition
* Currently pregnant
* Enrolled in a concurrent study that may confound the results of this study
Temporal Profile of Biomarkers Associated to Perioperative Stress Due to Carotid Endarterectomy Under Regional Anesthesia

Carotid endarterectomy (CEA) is a high risk surgical and anesthesiological procedure. It is an essential part of stroke-prevention strategies, however the incidence of CEA related peri-operative stroke is between 5% and 10%. These procedures can be performed either in general or regional anaesthesia. We hypothesized that an appropriate awake sedation is able to decrease patient's distress and an improved satisfaction can be reached.

We aim to explore the stress response of patients randomized according to different sedation protocols: (i) per os premedication only with alprazolam (BDZ group) or (ii) premedication with alprazolam combined with target control infusion (TCI) of propofol (BDZ+TCI) for awake carotid endarterectomy. A total of 50 consecutive patients with significant carotid artery stenosis will be enrolled into this prospective randomised study. All surgeries will be performed in regional anaesthesia. As premedication, all patients took 0.25 mg alprazolam 30 minutes before the procedure. After randomization 25 patients will be grouped to both arms of the study: either to "sedation with target controlled propofol infusion", or to "only premedication". Stress markers, such as cortisol plasma levels will be serially analysed: prior to surgery (T1), before (T2) and after release of carotid clamp (T3), at 2 (T4) and 24 post-operative hours (T5). Alprazolam levels were also measured before and after the surgery.

Eligibility Criteria:
Inclusion Criteria: patients with significant symptomatic or asymptomatic carotid stenosis scheduled for carotid endarterectomy, written informed consent -

Exclusion Criteria: patient declines to participate in the study

-
Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease

A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression.

The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. The investigators will do this using a combination of clinical, radiologic, and biologic features.

The central hypothesis is that novel quantitative imaging and specific blood markers will be associated with progressive RA-ILD. The hypothesis will be tested through collection and analysis of peripheral blood, in addition to the analysis of HRCT (high-resolution computed tomography) scans performed as standard of care (clinical) on research subjects.

Procedures performed:

Baseline Year 0: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs

Every 4 months (at clinic visit): Blood sample, questionnaires

Year 1 and Year 2 Follow-ups: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs

Eligibility Criteria:
Inclusion Criteria:

* Multidisciplinary diagnosis of RA-ILD based on the 2010 American College of Rheumatology criteria
* 18 years of age or older

Exclusion Criteria:

* Prior medication treatment specifically for RA-ILD
* Inability to give informed consent
* Pregnant women
Use of Ozone Gel as an Antimicrobial in Treatment of Periodontitis

Periodontitis is an inflammatory disease that destroys tooth-supporting structures through oral bacterial plaque. ozone gel's act as an antimicrobial effect as an adjunct to conventional periodontal therapy (scaling and root planning). exposure of bacteria to ozone leads to the oxidation of the phospholipids and lipoproteins that comprise the bacterial cell membrane. Ozone gel has the potential to play an anti-inflammatory role in the treatment of periodontitis by monitoring both clinical and biological parameters.

Periodontitis is an inflammatory disease that destroys tooth-supporting structures through oral bacterial plaque. Scaling and root planning are considered the gold standard treatment for periodontal disease. Antiseptics represent an aid to the gold standard nonsurgical treatment of scaling and root planning (SRP) for periodontal disease. Adjuncts to scaling and root planning have been introduced as ozone gel. This gel represents both antimicrobial and beneficial effects while expressing safe cytocompatibility toward host tissues, which is progressively developing.

The study aims to determine ozone gel's antimicrobial effect as an adjunct to conventional periodontal therapy (scaling and root planning).

Material and Methods: Twenty-one patients with periodontitis were enrolled in this study. There were 58 periodontal pockets divided into two groups by a blinded split-mouth design. The control group had 28 periodontal pockets treated with scaling and root planning only, while the test group had 30 with scaling and root planning and ozone gel. Two gel applications were applied at baseline and one month after the treatment. Plaque index, bleeding on probing, probing pocket depth, and relative attachment level were recorded. Gingival crevicular fluid samples were collected from the pockets at each site for both groups at different time intervals. The GCF sample was transferred into Eppendorf tubes containing 1.5 ml of PBS buffer, and the samples were stored in a freezer at -40˚C.

Eligibility Criteria:
Inclusion Criteria:

* The patient should be systemically healthy
* The patient has periodontitis equal to or more than two non-adjacent teeth, with probing pocket depth equal to or more than 4mm.
* Patients capable of following orders and motivation

Exclusion Criteria:

* Patients with removable dentures who undergo orthodontic therapy.
* Patients with teeth suffer from endo-periodontal lesions.
* Patients have three months of using anti-inflammatory medications, antibiotics, immune suppressants, or oral contraceptives.
* Patients having systemic conditions that affect the condition.
* Pregnant or nursing mothers.
* Patients who are smokers
Acceptability Study of Nutritional Supplements in Hospitalized Elderly Patients

Malnutrition is a major health problem with serious consequences for the quality of life of elderly people: it increases the number of hospitalizations and lengths of stay, worsens functional dependency and increases morbidity and mortality rates There are numerous recommendations and tools to detect or to manage malnutrition and the prescription of Oral Nutritional Supplements (ONS) can be a solution. As the elderly suffer from food monotony, as well as age-related changes, which may or may not be associated with the presence of disease, it is necessary to ensure full ingestion of the prescribed supplements to optimize the benefits provided by these products. To achieve this it is necessary to know the chemosensory characteristics of foods enjoyed by hospitalized elderly people who are malnourished or at risk of malnutrition. The investigators make the hypothesis that by further optimizing taste and energy content of foods, consumption by the elderly and the health benefits would be improved.


Eligibility Criteria:
Inclusion Criteria:

* Person who have given their written informed consent
* Person aged more than 65 years
* Person cognitively able to participate in tests and to answer questionnaires (Mini Mental Statement Estimation score (MMSE) equal to or greater than 21)
* Person with an Mini Nutritional Status score (MNA) lower than 23.5/30 for risk of malnutrition or malnourished
* Person without known unstable cardiac disease
* Person without high blood pressure

Exclusion Criteria:

* Person who are not covered by national health insurance
* Person suffering from severe illness during the test
* Person with a life expectancy lower than 6 months or with a cancer
* Every person with proven anosmia (total loss of olfaction) from birth or due to physical trauma (head trauma) or disease (acute rhinitis)
* Person with allergy (soya milk) or severe aversion to one of the foods that will be used during the study
* Person with swallowing disorders
* Person with a prescribed strict food diet
* Person with an instable diabetes
Virtual Reality in Lower Limb Adult Burn

To investigate the potential effects of Wii fit rehabilitation programs on functional capacity, mobility, balance and muscle strength in lower limb burn patients after hospital discharge.

The use of virtual reality technology in burn conditions improved joint flexibility and reduced pain associated with physical therapy, dressing changes, and wound debridement. However, the primary concern of burn rehabilitation is not only survival but also maximizing functional outcome and decreasing the time for return to work.

Eligibility Criteria:
Inclusion Criteria:

* adult with a deep partial thickness or a full thickness burn in the lower extremities.
* induced by either a scaled or a flame thermal burn.
* total body surface area (TBSA) more than 40%.
* age ranged from 18 to 40 years.
* recent hospital discharge.

Exclusion Criteria:

* Infection.
* Diabetes.
* inhalation injury.
* Fracture.
* degenerative joint diseases of the lower extremities.
* peripheral nerve diseases.
* Pre-established psychologically and physically disorders.
Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization

This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor Overactivity (NDO)-related incontinence following Spinal Cord Injury (SCI), who have persistent incontinence after standard of care therapy and who perform Clear Intermittent Catheterization (CIC) on a regular basis.

This first-in-human clinical study, performed in SCI participants with Urinary Incontinence (UI) due to NDO and an inadequate response to current therapy, will evaluate the safety and tolerability of EG110A, and explore the potential doses for further clinical development. The present clinical study will also investigate the efficacy of EG110A via data collected in a bladder diary and via urodynamic assessments.

Eligibility Criteria:
Main Inclusion Criteria:

1. Participant has stable supra-sacral traumatic SCI with American Spinal Injury Association (ASIA) Impairment Scale grade A, B, C, D or E which occurred at least 12 months before Screening.
2. Participant has UI due to urodynamically-confirmed NDO for at least 3 months prior to Screening.
3. Participant has:

   1. been treated for NDO for at least 3 months prior to Screening with an adequate course of oral pharmacotherapy(ies) and/or has had intolerable side-effects and/or exhibited an inadequate response in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week despite consistent use of the therapy. Participant does not wish to proceed to BoNT/A treatment, and their next step would be surgical intervention.

      OR
   2. had an inadequate response to BoNT/A treatment in the opinion of the investigator and participant, i.e., at least 8 UI episodes in a week, and the last BoNT/A treatment for their NDO was at least 9 months prior to the anticipated date of dosing (Day 1). Treatment with BoNT/A was not started more than 7 years ago, and their next step would be surgical intervention.

Main Exclusion Criteria:

1. Participant has previous or current tumor or malignancy affecting the spinal column or spinal cord, or any other nonstable cause of SCI.
2. Participant with active oral or genital herpes lesion. If the participant has an active oral or genital herpes infection this needs to be treated and healed first. The participant may be rescreened once the lesion has fully healed (at least 4 weeks after the lesion has healed).
3. Participant had cancer therapy or radiotherapy ≤ 4 weeks prior to Screening and has toxicities/AEs attributable to previously administered cancer therapies that have not resolved or stabilized.
Comparation of Bilateral and Unilateral Erector Spinae Plane Block

Although laparoscopic cholecystectomy is a minimally invasive surgery with many advantages, it is one of the operations with high postoperative pain scores. Opioids are frequently used to prevent postoperative pain. Due to the side effects of opioids, the amount of use is tried to be reduced. Regional anesthesia techniques can be used to minimize opioid consumption. Erector spina plane block was first described in 2016 by Forero et al. in the treatment of thoracic neuropathic pain. Since then, ESP block has been used as an anesthetic and analgesic technique. It is applied by injecting local anesthetic into the fascial plane located between the erector spina muscle and the transverse process of the vertebra. Several high-level studies have shown that the ESP block can be used to reduce postoperative pain after gastrointestinal surgery. Several studies have evaluated the effect of ESP block for pain relief after laparoscopic cholecystectomy. ESP block has been applied unilaterally or bilaterally in various studies. However, in the current studies in the literature, the advantages or disadvantages of the bilateral application of the ESP block compared to the unilateral application have not been evaluated. In this study, the investigators aimed to evaluate postoperative pain by applying ESP block to patients who underwent laparoscopic cholecystectomy and to evaluate the advantages of unilateral or bilateral application of ESP block over each other.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent laparoscopic cholecystectomy surgery between December 2021 and January 2022 will participate in the study.

Exclusion Criteria:

* There is no exclusion criteria for the study.
Fear of Cancer Recurrence in Genitourinary Cancer

To perform an analysis of independent predictors of fear of cancer recurrence in patients with malignant genitourinary diseases and their impact on quality of life and survival


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed diagnosis of either prostate, urothelial cell, testicular or renal cell cancer
A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women

This community-based randomized trial tested the effects of a social support intervention to increase Chamorro, Samoan, and Tongan women's Pap test behavior and social support among their male spouses or significant others in Southern California.

The purpose of this five-year community-based randomized trial was to: 1) examine the Pap test decision making process in Pacific Islander women; 2) assess the role of social support within the decision making process; and 3) develop and test an intervention to increase Pap testing among Pacific Islander women, and support among their male spouses/significant others. The intervention was created utilizing a Multi-Attribute Utility model and social support theory resulting in gender-specific educational workshops consisting of a social support intervention that informed both Pacific Islander women and men about cervical cancer and the importance of Pap testing for Pacific Islander women, and aimed to increase social support among their male spouses/significant others.

Eligibility Criteria:
Inclusion Criteria:

* Women ages 21 to 65
* Of Chamorro, Samoan, and/or Tongan ethnicity
* Has a significant other (married or in a long-term relationship for more than 5 years).

Exclusion Criteria:

* Not a member of one of the churches or clans visited for recruitment
The Impact of Immune Cell Changes During the Perioperative Period on the Prognosis of Patients With Colorectal Cancer

This is a multi-center, prospective, non-interventional real-world study. In a real-world environment, in line with the current status of the domestic diagnosis and treatment process, and on the premise of not increasing the burden of patients and medical resources, we explore the best indicators for predicting the outcome of patients with Clinical Research Coordinator (CRC) after surgery. The inclusion criteria for patients are perioperative patients with CRC. Real-world data analysis were conducted to determine whether immunization interventions versus non-interventions were able to improve patients' clinical outcomes (OS, PFS).


Eligibility Criteria:
Inclusion Criteria:

1. 18-85 years old, regardless of gender;
2. Patients with newly diagnosed CRC who are planned to undergo surgery (including patients with metastases but still feasible for surgery);
3. Patients who have not been diagnosed for the first time and have not received surgical treatment and now planned to undergo surgery(e.g., patients after neoadjuvant radiotherapy and chemotherapy for middle and low rectal cancer).

Exclusion Criteria:

1. Patients who refused to sign informed consent;
2. Patients complicated with other tumors;
3. Pregnant or lactating women;
4. People with a history of psychotropic drug abuse and unable to quit or those with mental disorders;
5. Postoperative histopathological examinations for patients with non-CRC type;
6. Patients who could not be followed up.