cyrilzakka/clinical-trials huggingface dataset:
Nutrition-based Interventions to Prevent Cognitive Decline

This study intends to evaluate the feasibility and the effectiveness of an innovative and integrated nutrition-based intervention addressing key modifiable risk factors for dementia while meeting participants' preferences for nutrition-related sessions. The intervention will include lifestyle group sessions regarding nutrition education and physical activity, individualized nutrition-based cognitive training at home, as well as clinical nutrition consultations.

The present project is a randomized controlled trial (RCT) to study the feasibility and effectiveness of a 6-month nutrition-based intervention designed to prevent cognitive decline in adults at higher risk of dementia.

Eligible individuals (n=120) recruited at primary health care centers or in the community will be randomized (1:1) into two arms: intervention and control groups.

The intervention group will be invited to participate in nutrition-based sessions of 180-minutes per week, directed by a nutritionist, to improve participants' skills in preparing healthy meals and reduce sedentary behaviours. Participants will also be asked to perform nutrition-based cognitive training at home and to attend individualized clinical nutrition consultations.

The control group will participate in data assessment and will receive a healthy recipes cookbook to thank for their participation. They will also receive an invitation to participate in free healthy cooking workshops, which will be offered upon the completion of data collection.

Both groups will continue receiving the usual standard care in their healthcare unit.

Participants' assessments will be performed at baseline and will be repeated at the end of intervention (6 months after the beginning of the intervention). A follow-up assessment will be conducted 6 months after the intervention concludes. Adherence outcomes, as well as lifestyle, health and anthropometric data, cognitive performance, subjective memory complaints, anxiety and depression, quality of life and self-reported physical activity will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Aged from 55 to 85 years old;
* At least 4 years in the regular school system;
* Higher individual risk for dementia defined as a score ≥6 points on the Cardiovascular Risk Factors, Aging and Dementia Dementia Risk Score (CAIDE).

Exclusion Criteria:

* Montreal Cognitive Assessment (MoCA) score lower than the validated cutoff points defined as 2 standard deviations below the normative reference value for the corresponding age and education in the Portuguese population;
* Having a medical condition limiting the participation in the intervention (e.g., blindness, amputation...);
* Lack of autonomy in daily activities;
* Diagnosis of dementia or major incapacity.
Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System

The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter defibrillator (ICD)for treating ventricular tachyarrhythmias. The S-ICD electrode and pulse generator emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, but then the S-ICD system will be removed entirely.

The objectives of this study are to further evaluate the S-ICD system's ability to identify and terminate induced ventricular tachyarrhythmias in patients acutely with an S-ICD emulator and parasternal electrode during the implant procedure of a standard transvenous ICD.

The active emulator is not a powered medical device and all elements of the test system are removed following the testing.

This acute intra-operative protocol will test the ability of the electrode and emulator to appropriately convert the arrhythmia and allos an assessment of post shock pacing.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring ICD therapy according to National Centre for Clinical Excellence (NICE) criteria are eligible
* And patients who require replacement of an existing transvenous ICD system are eligible

Exclusion Criteria:

* Patients unable or unwilling to provide informed consent
* Any conditions which precludes the subject's ability to comply with the study requirements, including completion of the study
* Females who are pregnant or lactating and pre-menopausal women who are unwilling to use adequate birth control for the duration of the study
* Participation in another investigational device trial at any time during the conduct of this study
* Patients with a serious medical condition and life expectancy of less than one year
* Patients with documented spontaneous and frequently recurring VT that is reliably terminated with anti-tachycardia pacing
* Patients with existing epicardial patches or subcutaneous electrodes in the left thoracic quadrant
Hemodynamic Monitoring in Women Throughout Cesarean Sections

In this study we would like to monitor cardiac output by the use of NICAS bioimpedance in women undergoing cesarean section delivery.

This study is a purely observational study, it will not have any clinical intervention nor will it interfere with standard cesarean delivery protocols in any way. This study's primary objective is to evaluate how spinal and general anesthesia influences cardiac output during cesarean section deliveries. Secondary endpoints is whether the hemodynamic changes as measured in cardiac output correlate with women's pain, measured by a visual analogue scale(VAS) from o-10. (0=representing no pain at all, 10= worse pain imaginable)

This is a prospective, single center study which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital. The Institutional Review Board has approved this study.

Two hundred women undergoing cesarean sections will be enrolled after filling out an informed consent form. Women will be recruited half an hour preoperatively in the women's surgery waiting room when they aren't experiencing any pain, and aren't under any sedatives.

Following obtaining an informed consent maternal cardiac output will be monitored.

The monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes.

Monitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the post anesthesia care unit (PACU).

Preoperative data will be compared to intraoperative and postoperative data, and will be analyzed in order to evaluate the dynamic cardiac output changes in women undergoing cesarean sections.

Recorded data will include:

* Demographic and obstetric - age, weight, height, current hemoglobin, co-morbidities, regular medication and other obstetric data.
* Cardiovascular risk factors - a family history of cardiovascular disease, smoking, BMI
* Obstetric history - obstetric background (history of gestational diabetes, preeclampsia, intrauterine growth restriction (IUGR), stillbirths or placental abruption).
* Threshold of pain according to VAS It should be emphasized that the conduct of the study will not interfere in with cesarean delivery protocol in any way.

Eligibility Criteria:
Inclusion Criteria:

- All women undergoing cesarean section in Beilinson Hospital following obtaining written informed consents forums with the ability to comply to the study requirements will be included in our study.

Exclusion Criteria:

- Women under age 18 , and women who don't understand the inform consent form will be excluded from participating.
Carbon Dioxide-laser Versus Harmonic Scalpel in the Treatment of Pelvic Pain Due to Endometriosis

The purpose of this study is to compare laser CO2 ablation/excision of Endometriosis (AFS stages 1-3) with excision of endometriosis using the Ethicon Harmonic ACE device. Pain scores at 6 months was the primary outcome, but secondary outcomes assessed pain scores at 1, 3 and 5 years as well as psychological state and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Endometriosis grade I-III by revised American Fertility Society Scoring
* Patients in whom laser treatment to the endometriosis is considered the treatment of choice.
* Patients having consented to participated in the trial
* Patient is 18 years old or greater
* Patients who have no contraindications to either of the treatment modalities proposed

Exclusion Criteria:

* Patients who do not wish to participate/have not signed the informed consent form
* Pregnancy of breast feeding
* Patients who are unable or unwilling to discontinue hormonal treatment for 6 months
* Patients who have received additional treatment for their endometriosis within 6 months of surgery
* Patients with documented painful conditions of the gastrointestinal or urinary system
Comparison of the Effects of Nasal and Oral Airway Use on Gastric Insufflation

The goal of this clinical trial is to compare the effects of nasopharyngeal and oropharyngeal airway on gastric insufflation in patients undergoing general anesthesia and expected difficult mask ventilation. The main questions it aims to answer are:

* Is there a difference between the presence of gastric insufflation in the use of nasopharyngeal and oropharyngeal airways?
* Is there a difference between the antral area sizes measured before and after ventilation After general anesthesia induction, nasopharyngeal or oropharyngeal airway will be placed in participants and real-time ultrasonographic gastric antral area imaging will be performed during mask ventilation. Researchers will compare the effects of nasopharyngeal and oropharyngeal airway use on gastric insufflation.

Patients who are expected to have difficult mask ventilation and receive general anesthesia will be included in the study. After preoperative gastric antral area measurements of the patients by ultrasonography, preoxygenation will be applied and anesthesia induction will be performed. Real-time gastric ultrasonography will be performed during pressure-controlled mask ventilation for 2 minutes after nasopharyngeal or oropharyngeal airway insertion, and then antral area measurement will be repeated. After the trachea was intubated, the antral area measurement was once again performed. At the 30th, 60th, 90th and 120th seconds of ventilation, patients' SpO2, EtO2, EtCO2, peak airway pressure, tidal volume, leak volumes and hemodynamic changes will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving general anesthesia
* ASA score I-II-III
* At least 3 criteria out of 5 difficult mask criteria defined by Langeron et al.

Exclusion Criteria:

* Patients who did not give informed consent
* Risk of aspiration
* Respiratory disease
* Facial, oropharyngeal or nasopharyngeal pathology
* Pregnancy
Upper Limb Cross-education in Subacute Stroke

This study evaluates how cross-education (unilateral training) affects muscle strength of the paretic limb in acute stroke patients. Half of the hemiplegic patients will receive conventional treatment and transcutaneous electrical nerve stimulation (TENS) to non-paretic side, while other half will receive conventional treatment and electro muscular stimulation (EMS) to non-paretic side.

Cross-education, which means the performance improvement in the untrained homologous muscle after unilateral exercise training, is studied in various orthopedical and neurological conditions affecting the body unilaterally. For those with asymmetrical weakness and immobility after stroke, training the non-paretic side can be utilized to increase the strength of the paretic side and improve functional symmetry. In this study, investigators aim was to examine whether training non-paretic upper extremity wrist flexor muscles by EMS in adjunct to conventional training program, has additional benefits upon the muscle powers of the homologous agonist and antagonist muscles. Investigators will use low frequency antalgic TENS stimulation at barely sensible level, which is considered not to cause muscle strengthening, as a control intervention.

Eligibility Criteria:
Inclusion Criteria:

* thromboembolic stroke,
* \<6 months of stroke,
* right hand dominancy,
* left hemiplegia,
* Brunnstrom stage ≥ 3 of recovery for upper extremity and hand

Exclusion Criteria:

* myopathy, tendinopathy, peripheral neuropathy of the upper extremities,
* auditory, cognitive or speech disorder that enables communication,
* history of fracture or arthrodesis in the upper limb,
* contracture or severe spasticity (Ashworth scale ≥ 2) in forearm muscles,
* severe cardiovascular disorders (heart failure, coronary artery disease, drug resistant hypertension)
Obesity Treatment in a Managed Care Setting

The aim of the present study is to evaluate the effectiveness of two different delivery formats for weight management in a managed care setting. Mail-based weight counseling and phone-based weight counseling will be compared to each other and a control condition. Primary outcomes are participation rates in programs, weight change, and cost.


Eligibility Criteria:
* at least 18 years of age
* BMI ≥ 27.8 kg/m2 for men
* BMI ≥ 27.3 kg/m2 for non-pregnant or lactating women
A Multicenter Phase II Trial of Post-operative Concurrent Chemoradiotherapy Using Weekly Cisplatin With Tislelizumab for Patients With High-risk Head and Neck Squamous Cell Carcinoma：The POTENTIAL Study

To investigate whether concurrent Tislelizumab with postoperative chemoradiotherapy would have survival benefit in high Risk HNSCC Patients.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed squamous cell carcinoma of the head and neck. Site of tumor origin in the oral cavity, oropharynx (p16-), larynx, or hypopharynx
2. With at least one high risk factor after radical surgery ①positive margin; ②close margin（\<5mm); ③ENE.
3. No distant metastases
4. No synchronous or concurrent head and neck primary tumors
5. ECOG PS 0-1
6. Adequate organ function including the following:

Absolute neutrophil count (ANC) \>= 1.5 \* 10\^9/l Platelets count \>= 80 \* 10\^9/l Hemoglobin \>= 80 g/dl AST and ALT \<= 2.5 times institutional upper limit of normal (ULN) Total bilirubin \<= 1.5 times institutional ULN Creatinine clearance \>30 ml/min 8. Signed written informed consent

Exclusion Criteria:

1. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
2. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
3. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
4. Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
5. Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment
6. Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;
The Impact of Chronic Mitochondrial Antioxidant Supplementation on CardiovascularToxicity in Breast Cancer Patients

Investigate the protective effect of chronic MitoQ supplementation on cardiovascular toxicity induced by doxorubicin-based adjuvant chemotherapy in breast cancer patients.

Test the hypothesis that chronic MitoQ supplementation in breast cancer patients treated with doxorubicin prevents:

1. increased mitochondrial oxidative stress;
2. the increase in cardiac markers (B-type natriuretic peptide and troponin I);
3. changes in left ventricular deformity (speckle tracking, strain) and reduction in LVEF;
4. endothelium-dependent dysfunction of peripheral vascular beds;
5. the increase in endothelial microvesicles;
6. the increase in material stiffness;
7. the elevation of central blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old, diagnosed with breast cancer (ductal, lobular and mixed carcinoma), in stage 1-3, with indication for the adjuvant AC-T therapeutic scheme, doxorubicin (60 mg/m2) plus cyclophosphamide, will be considered eligible for the study (600 mg/m2) in the regimen of 1 cycle every 21 days, followed by weekly taxane for 12 cycles.

Exclusion Criteria:

* Patients with metastasis, severe lymphedema, renal failure, acute myocardial infarction, heart failure, stroke and chronic liver disease.
A Pilot Study to Assess the Association Between Human Bioimpedance Measurements and Clinical Urodynamic Procedures

A Pilot Study to Assess the Association between Human Bioimpedance Measurements and Clinical Urodynamic Procedures

The purpose of the study is to assess how well Curbell's Bladder Sensor device measuring bioimpedance correlates to urodynamic studies and the reported sensation subjects feel when reporting bladder fullness and their urge to urinate.

Eligibility Criteria:
Inclusion Criteria:

* Patients that have been previously scheduled for a Urodynamic Study

Exclusion Criteria:

-
Voice Quality Changes With IANB Anesthesia

Background: Inferior alveolar nerve block anesthesia is commonly used in dental procedures, but its effect on the voice quality is not well understood. The aim of this study is to investigate the effect of mandibular anesthesia on the acoustic voice quality index.

Objective: The primary objective of this study is to determine the effect of mandibular anesthesia on the acoustic voice quality index.

Design: This is a within-subject study design. Participants will be recruited from a local dental clinic and will be adults aged 18 years or older. The participants will have the acoustic voice quality index measured before and after the administration of mandibular anesthesia. The parameters that will be measured include acoustic voice quality index and self ........ The data will be analyzed using appropriate statistical techniques.

Expected Outcome: The study is expected to provide insights into the effect of mandibular anesthesia on the acoustic voice quality index. The results of this study may help in understanding the impact of mandibular anesthesia on voice quality and may have implications for dental practitioners and patients who receive mandibular anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* able to provide informed consent
* able to communicate in the local language
* no history of voice disorders or speech therapy
* no history of any diseases or conditions that could affect voice quality.

Exclusion Criteria:

* pregnant or breastfeeding women
* individuals with a history of allergies or adverse reactions to anesthesia
* individuals with a history of any diseases or conditions that could affect voice quality
Nutritional Status of Adult Slovenes After the Covid-19 Epidemic

There is objective need to examine nutritional status (i.e., body mass index (BMI), body composition and dietary intake) of healthy adult Slovenes after SARS-CoV-2 (Covid-19) epidemic period.

In the Slovenian (pair of European Union) adult population (with only 2 million inhabitants), we do not yet have representative data on the body composition of adult Slovenes published in the scientific literature.

In the study after the Covid-19 pandemic period (4th wave) the investigators will use medically approved body analyzer (Tanita 780 S MA, Tokyo, Japan) and standardized food frequency questionnaire (FFQ). In addition, the investigators will measured body height of the participants with a portable altimeter (ADE MZ10042, Germany).

The research will include randomly recruited adults (participants) who will attend various free or/and paid publicly available seminars, congresses and fairs in Slovenia, directly unrelated topics to physical activity or healthy eating (i.e., healthy and active lifestyle) thus obtaining a more realistic current population status.

In the study investigators will randomly but voluntarily enroll 700-1000 healthy adult participants within inclusion/exclusion criteria that are willing to participate in the study. Investigators anticipate that for this number of adults (aged 18-80 years) will require approx. 5000 invited candidates (10-15 events), of both sexes.

The methods to be used are body composition monitor and FFQ. In addition to the assessment of BMI and body composition status, we will compare the proportion of obese subjects according to BMI and body fat percentage threshold criteria (by World Health Organization). For the dietary intake analysis the investigators will use the national a dietary software program, OPEN Platform for Clinical Nutrition, which is a web-based application developed by the Jožef Stefan Institute in Slovenia.

The power of the sample was calculated on the basis of published body composition data on the adult population of the scientific monographs of the Slovenian National Institute of Public Health and data on the BMI of the scientific research on the dietary intake status of adults (SI.Menu).

The participants included in the study will signed consent form for inclusion in the study and will not be remunerated financially for participation in the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults
* No BMI restriction
* Randomly invited

Exclusion Criteria:

* Without currently competitive or top level athletes
* Without pregnant or lactating women and physically handicapped individuals
* Without active common chronic diseases (i.e., cancer, CVD, autoimmune diseases ect.)
* Without individuals with a pacemaker
18FluoroLDOPA PET Imaging for the Detection and Localization of Focal Congenital Hyperinsulinism

The goal of this project is to determine the role of FDOPA/PET as a pre-operative diagnostic imaging procedure for differentiating focal and diffuse forms of congenital hyperinsulinism and locating focal lesions in the pancreas to guide surgical resection.

Congenital hyperinsulinism (HI) is the most common cause of recurrent and persistent hypoglycemia, presenting early in infancy. Patients who fail medical therapy usually require resection of the diseased pancreas(partial or subtotal pancreatectomy) to control this disorder. Over half of patients undergoing surgery have a focal area of islet cell dysfunction that is curable with resection. These focal lesions are areas of adenomatosis consisting of a clone of beta-cells that express a paternally-derived mutation of the KATP channel due to loss of heterozygosity for the maternal allele. Current imaging techniques cannot differentiate focal and diffuse forms of hyperinsulinism, nor can they locate focal areas of disease within the pancreas before surgery. L-DOPA is taken up by some neuroendocrine cells, including pancreatic islet cells, and stored as dopamine in secretory granules. Recent studies show that positron emission tomography (PET) following administration of 18F-fluoro-L-DOPA (FDOPA) can distinguish focal and diffuse forms of HI and accurately locate focal lesions within the pancreas.

Eligibility Criteria:
Inclusion Criteria:

* Any age, but primarily infants 0-6 months given typical age of initial presentation.
* Children with diagnosis of FoHI or DiHI based on clinical criteria (fasting hypoglycemia accompanied by inadequate suppression of plasma insulin, inappropriately low plasma free fatty acid and plasma-hydroxybutyrate concentrations, and an inappropriate glycemic response to glucagon injection)

  o confirmed by genetic testing for mutations in ABCC8 and KCNJ1 was1.
* Hypoglycemia uncontrolled with medical management (diazoxide, octreotide).
* Able to withdraw medications in time to wash out prior to the scheduled PET scan.
* Patients fulfilling criteria above but with uncontrolled hypoglycemia after initial surgical management (partial or near-total pancreatectomy)
* Normal hepatic and renal function.

Exclusion Criteria:

* Treatment with other, third-line, medications for hyperinsulinism (nifedipine, glucagon).
* Patients with hepatic or renal insufficiency.