cyrilzakka/clinical-trials huggingface dataset:
Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications

The purpose of this registry is to evaluate the impact on patient outcome and on healthcare utilization of cardiac implantation electronic device complications during a long-term follow-up.

Multicentric, observational, prospective registry enrolling consecutive patients underwent pacemaker or defibrillator implantation, aimed to evaluate the impact of cardiac implantable device complications requiring surgical revision on healthcare utilization (number and length of hospitalizations), and on patient outcome (all-cause mortality and cardiac mortality), during a long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* patients underwent cardiac implantable electronic device implantation according to current guidelines during the enrollment period.

Exclusion Criteria:

* patients already carriers of a cardiac implantable electronic device underwent replacement or upgrading of device.
The Antihypercholestrolemic Effect of a Combined Nutritional Supplementation of Standardized Extracts of Amla, Walnut, Red Yeast Rice and Olive

Nutraceutical lipid-lowering interventions are becoming increasingly popular, particularly among patients who are intolerant or refractory to prescription statins, or who desire alternative non-conventional pharmacological treatment to manage their dyslipidaemia, whether they previously experienced statin intolerance or not. A growing body of preclinical and clinical evidence suggest that the amla (Emblica officinalis) red yeast rice (RYR), olive and walnut leaf extracts posses consideable hpolipidaemic pharmacological effects.

The present exploratory study aimed to assess the safety, efficacy, and patient's satisfaction of a combined supplementation of amla, red yeast rice, olive, and walnut leaf extracts (Cholesfytol NG®) on total cholesterol (TC), low-density lipoprotein - cholesterol (LDL-C), high-density lipoprotein - cholesterol (HDL-C), non-high-density lipoprotein - cholesterol (non-HDL-C), remnant cholesterol (RC) and triglycerides (TG) in hyperlipidaemic patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21 years
* Both male or female
* Blood total cholesterol (TC) level ≥ 200 mg/dL
* Blood low-density lipoprotein cholesterol (LDL-C) level ≥ 130 mg/dL
* With or without myalgia and/or diabetes
* No prior treatment of cholesterol-lowering agents and/or patients whose cholesterol- lowering treatment did not allow them to reach LDL-C target
* Patients who had stopped their cholesterol-lowering treatment because of side effects including myalgia

Exclusion Criteria:

* Pregnant nor breastfeeding patients
Synergistic Innovative Functional Food Concepts to Neutralize Inflammation for Cardiometabolic Risk Prevention

The aim of the study is to evaluate the synergistic effects of daily consumption of food products fortified with bioactive components (fibres, polyphenols, omega-3, Slow Digestible Starch) for 9 weeks, compared to the daily intake of standard food products on low-grade inflammation in cardiometabolic risk subject.

The inflammatory parameters will be assessed in fasting and in postprandial period after the consumption of a hyper-carbohydrate and hyper-lipidic test meal called Flexmeal. A metabolic stress will be induced by a fructose ingestion challenge during the last 6 days of interventional period.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* Body Mass Index of 25 to 35 kg/m2
* Waist circumference greater than 80 cm for women and than 96 cm for men
* Daily biscuits consumption
* Fibers intake \<25g/day

Exclusion Criteria:

* Medical history of digestive surgery or disease
* Large polyphenols food products consumer (cranberries, red berries, coffee, tea, red wine, fruits and vegetables...)
* Current or recent (\<12 weeks) intake of antibiotics or gastro-intestinal medicinal product
* Current probiotics, prebiotics, fibers complement, and/or any products modulation gut transit
* Feeding particular diet such as vegetarian diet or hyperprotein diet
* Current weight loss diet
* Pregnant or lactating woman or woman who did not use effective contraception
* Drinking more than 3 glasses of alcohol per day (\>30g/day)
* Smoking more than 5 cigarettes per day
The Effect of Midazolam Premedication on Copeptine Concentration in Blood

The study aim is to assess whether premedication with midazolam prior to surgery affects copeptin concentration in blood.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective surgery
* Patients with no chronić illness and considered ASA 1 by anesthesiologist
* Patients with mild and controlled chronic illness considered ASA 2 by anesthesiologist

Exclusion Criteria:

* Patient refusal
* Chronic illness requiring intense treatment or uncontrolled illness (ASA 3 or more)
Ketamine Infusion as a Method of Cerebral Protection in Children

The study is devoted to the use of ketamine infusion in a subanesthetic dose in the postoperative period in children after surgical correction of congenital heart defects in children.

The study will examine the safety and effectiveness for neuroprotection of subanesthetic doses of ketamine in the postoperative period in children undergoing operations to correct septal congenital heart defects using cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* age from 1 to 60 months
* body weight from 3.5 to 20 kg
* planned surgical intervention to correct a congenital heart defect (atrial or ventricular septal defect) with CPBё
* the presence of informed consent for participation in the study signed by the child's legal representative

Exclusion Criteria:

* lack of informed consent of the patient and parents to participate in the study,
* emergency and urgent surgical interventions;
* the presence of clinically significant anemia;
* hypo-thermic during operation, episodes of desaturation in the perioperative period;
* the presence of another congenital heart diseases besides the atrial or ventricular septal defect, as well as their combination;
* a history of central nervous system diseases;
* an installed pacemaker;
* hemodynamic instability requiring preoperative pharmacological and/or mechanical support;
* any episodes of cerebrovascular accidents in the history or periop-erative period;
* the presence of a patient with severe concomitant diseases that worsen mental and somatic conditio;
* acute infection and exacerbation of chronic infection in the perioperative period;
* concomitant autoimmune diseases;
* the presence of malignant neoplasms;
* surgical complications in the postoperative period.
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults

Consumption of (poly)phenols is recognized to have beneficial effects on health. However, heterogeneous results are obtained in clinical trials due to high inter-individual variability. The objective of this pilot study is to characterize the inter-individual variability associated with the interaction of (poly)phenols from cranberry and gut microbiota.

The participants (n=39) of this study are healthy adults aged between 23 and 63 years old and consumed cranberry extract rich in (poly)phenols for 4 days. Plasma, urine and feces were collected to quantify gut microbial (poly)phenols metabolites and to profile the fecal microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Stable weight
* Stable or no medication
* Stable diet
* Stable physical activity

Exclusion Criteria:

* Pregnant women
* Antibiotic and/or probiotic use three months prior to the study
* Smokers
Efficacy of Sialic Acid GNE Related Thrombocytopenia

Sialic Acid-Extended Release (SA-ER, aceneuramic acid, UX001) is an extended release formulation of sialic acid (SA, also known as N-acetylneuraminic acid or NANA). The SA-ER is currently studied as a substrate replacement therapy for patients with GNE myopathy. The investigators plan to study the SA-ER compound in a cohort of five patients with GNE-related thrombocytopenia.

The investigators identified 5 affected individuals (3 males and 2 females from three families, age 19-40 years) with GNE-related thrombocytopenia . All subjects will receive 2 gram SA-ER, three times per day for a total daily dose of 6 grams (6,000 mg). The dose should be administered with food (i.e. within 30 minutes of a meal or snack).

Efficacy will be evaluated by improvement in clinical and laboratory assessments. Results from Baseline assessments will be compared with those of post-treatment assessments with efficacy conclusions based on improvement between Baseline and the last scheduled assessment. Safety will be evaluated by the incidence and frequency of adverse events, including clinically significant changes from Baseline to scheduled time points in:

* Vital signs.
* History and physical examination findings.
* Laboratory evaluations.
* Serum uric acid levels and urinary excretion of uric acid.

Eligibility Criteria:
Inclusion Criteria:

* Patients with GNE-related macrothrombocytopenia in the investigated family

Exclusion Criteria:

* non consenting for this study
* pregnancy
Imagery as Biomarker of Gout

The objective of this study is to determine whether MSU crystal deposits visualized on ultrasound and/or DECT are associated with the development of symptomatic gout (according to ACR 2015 / EULAR criteria) over 5 years in hyperuricemic individuals.

Cross-sectional studies have shown that 17% to 86% of people with apparently asymptomatic hyperuricemia have ultrasound evidence of monosodium urate (MSU) crystal deposition. These observations suggest that this deposition constitutes the first stage of the clinical gout syndrome, which has led to a revised model of disease progression and staging. However, no longitudinal studies have been undertaken to determine whether such findings are needed for the development of gout, or to investigate pathological mechanisms responsible for the transition from asymptomatic crystalline deposit to gout. Only a prospective cohort study of people at risk who are carefully and regularly followed can answer such questions.

Dual-energy computed tomography (DECT) and ultrasound are the two imaging techniques that allow the visualization and quantification of MSU crystals. Ultrasound is the most widely used technique; it allows the identification of the deposit of crystals of on the surface of the cartilage (double contour sign) and of the tophi. The DECT can detect the deposition of MSU crystals in soft tissues as long as the amount of crystals exceeds the spatial resolution of the machine (about 250 μm).

The international collaborative study TIGER (Transitions in gout research study) aims to address the question of the predictive value of the deposition of MSU crystals "silent" in the development of gout, through an international cohort (7 countries) including 907 asymptomatic hyperuricaemic individuals. These individuals will have initial ultrasounds to investigate the presence of MSU crystal deposits and a 5-year follow-up. Given the aforementioned ultrasound reproducibility issues, DECT analyzes will be added to the baseline assessment of TIGER participants to provide exploratory data on DECT as a potential biomarker for the impending development of gout.

Eligibility Criteria:
Inclusion Criteria:

* Serum urate level ≥ 80 mg/L on inclusion,
* No current or previous clinical symptoms of gout (including clinically apparent flares or tophus),
* Between 18 and 80 years old,
* Able to give informed consent.

Exclusion Criteria:

* GFR (glomerular filtration rate) \<30 ml / min / 1.73 m² or dialysis,
* Serious illness with a poor prognosis of less than 5 years,
* Autoimmune inflammatory arthritis,
* Change of geographical area within 5 years,
* Previous analysis of synovial fluid showing crystals of MSU,
* Presence of subcutaneous tophi,
* Taking a hypouricaemic treatment (allopurinol, probenecid, benzbromarone, febuxostat, lesinurad), canakinumab, anakinra or colchicine,
* Uricemia observed only after an acute decompensation of comorbidity
* Pregnant or breastfeeding women
The Effect of Partıcıpatıon in Care of Mothers

The aim of the study is to examine the effect of including mothers with newborn babies in surgical intensive care units during the nursing care process on mother's self-confidence and mother-infant attachment.

Population and Sample of the Research

The population of the study consists of mothers who were hospitalized with their babies in the surgical intensive care unit in a children's hospital in Ankara (Turkiye). It is planned that the mothers who were hospitalized with their babies in the surgical intensive care unit for a period of 6 months between the dates of the study and who met the criteria for inclusion in the study constitute the sample of the study.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient treatment of the baby in the surgical neonatal intensive care unit without the mother's presence since birth
* The mother stays with the baby for at least 4 days in the post-operative period
* The mother does not have any communication and language problems
* The mother's willingness to participate in the research

Exclusion Criteria:

-
Using Mobilization Exercises on Total Knee Arthroplasty Rehabilitation

There is no definite evidence about the most effective treatment approach in early-stage rehabilitation after total knee arthroplasty surgery. The purpose of this study is to investigate the effects of mobilization exercises applied with classical exercises on pain, joint range of motion, edema, function, quality of life and patient satisfaction in early stage rehabilitation after total knee arthroplasty surgery.

There is no definite evidence about the most effective treatment approach in early-stage rehabilitation after total knee arthroplasty surgery. The purpose of this study is to investigate the effects of mobilization exercises applied with classical exercises on pain, joint range of motion, edema, function, quality of life and patient satisfaction in early stage rehabilitation after total knee arthroplasty surgery. Patients with bicompartmental total knee arthroplasty operation due to knee osteoarthritis will randomly assign to 2 groups. Patients in group 1 will treat with mobilization exercises in addition to classical exercises performed in the early post-op period; patients in group 2 will treat only with classical exercises.

Eligibility Criteria:
Inclusion Criteria:

* Patients with TKA surgery due to the diagnosis of knee OA
* Between the ages of 50-75 years

Exclusion Criteria:

* Revision TKA,
* Previous unicompartmental arthroplasty or tibial osteotomy,
* Hemophilia,
* Rheumatic diseases,
* Lower extremity fractures and tumors,
* Neurological diseases leading to muscle weakness in the lower limbs,
* Patients with emotional and cognitive problems
Study of Pancreatic Neuroendocrine Tumors and Carcinomas in Alsace Region

Pancreatic Neuroendocrine tumors and carcinomas (pNET) see the last year their incidence and prevalence going up. On the basis of their grade of differentiation and proliferation ratio measured Ki67 staining, there are divided into 3 grade groups : Grade 1 with Ki67 between 1 and 3%, Grade 2 between 3 and 20% and well-differentiated neuroendocrine grade tumors 3 with KI67 greater than 20%, so undifferentiated carcinomas.

pNET is a heterogenous group of tumors with variable prognosis. The aim of this study is to identify the prognostic factors in this population, as well the place of neutrophil-to-lymphocyte ratio as a prognostic marker. The primary endpoint is the description of clinic and pathological parameters of patients from Alsace. The secondary endpoints are the identification of prognostic factors in this population


Eligibility Criteria:
Inclusion criteria:

1. Major topic ((≥18 years)
2. Subject with histologically confirmed pancreatic neuroendocrine tumor or carcinoma
3. Subject with tumours or neuroendocrine carcinoma of the pancreas at any stage of the disease.
4. Subject covered in one of the participating centres between 01/01/2008 and 01/01/2019
5. Have a pre-therapeutic biological check-up
6. Subject who has not expressed opposition to the use of his or her data for research purposes

Exclusion criteria:

1. Subject who expressed opposition to participate in the study
2. Lack of histological data
3. Minor subject
4. Patient under the protection of justice
5. Subject under guardianship or trusteeship
Acupuncture to Improve Quality of Life in Patients With Advanced Cancer

This study will test the feasibility of acupuncture as a complementary therapy for advanced cancer by comparing symptoms and quality of life before and after 8 weeks of acupuncture treatments.

A large percentage of the practice and use of complementary and alternative medicine (CAM) in the United States is focused on cancer. Whether the CAM use is aimed at reducing one's risk of developing cancer or improving the quality of life of a cancer patient during treatment or at the end of life, the public focus on CAM and cancer has created a driving force for cancer centers to address the efficacy and science of these methods.

Currently, the majority of cancer patients do not receive adequate palliative care. Acupuncture has been shown to be effective in the treatment of pain and nausea and has also been shown to improve one's general well-being. Acupuncture also has some effectiveness in relieving symptoms of anxiety and depression. This study will evaluate the efficacy of acupuncture by Traditional Chinese Medicine clinicians to address the quality of life and symptoms of patients with incurable cancer.

Women with recurrent metastatic ovarian cancer and similar patients with advanced cancer who are ambulatory and receiving conventional palliative care will be enrolled in this study. Patients will continue to receive high-quality, conventional clinical interventions, including chemotherapy and pain and symptom reduction programs. Patients will also receive 8 weeks of acupuncture. Evaluation tools such as Satisfaction with Life Domains Scale for Cancer (SLDS-C), Brief Pain Inventory, and Rotterdam Symptom Check List will be used to assess the acupuncture intervention.

Eligibility Criteria:
Inclusion Criteria

* Advanced cancer patients, primarily ovarian cancer patients
* Undergoing palliative care treatment
* Ambulatory
* Symptomatic with pain, nausea, and/or an inadequate quality of life
* Platelets \> 25,000/mm3
* ANC \> 500 cells/mm3

Exclusion Criteria

* Acupuncture treatment during the 6 months prior to study entry
* History of bleeding disorder, such as hemophilia or von Willebrand disease
* Acute psychosis
Breast Lymph Node Mapping

The purpose of this study is to map the arm lymphatic drainage system in the axilla with blue dye and the breast drainage system with a radioactive material. By identifying the arm lymphatics they can be protected during surgery and this may decrease the occurrence of lymphedema. The information obtained in this study may provide us with better surgical techniques to identify and protect the arm lymphatic drainage system in the axilla.

This study is a non-randomized Phase II study of the Axillary Reverse Mapping (ARM) procedure for patients presenting with breast cancer requiring lymph node evaluation. The study will enroll 100 subjects, and will have two study arms: one for patients requiring only the SLNB procedure (roughly 67% of enrollees), and one for patients requiring a full ALND (roughly 33% of enrollees). For the analysis of study efficacy, each arm will be compared to its procedure-appropriate historical control for evidence of decrease in the 1-year lymphedema rate among patients undergoing SLNB or ALND.

Additional data will be collected on the treatment population's (a) variability in location of arm lymphatics, and (b) incidence of SLN crossover with arm lymphatics, along with success-rate data for identifying SLNs and arm lymphatics during SLNB and/or ALND. This additional data will add to our level of knowledge and experience regarding lymph node surgery.

Eligibility Criteria:
Inclusion Criteria:

1. 19-100 years old
2. Not pregnant or breastfeeding
3. Breast cancer requiring LN evaluation for the breast
4. Willing participation following an informed consent process

Exclusion Criteria:

1. Patient \< 19 y/o or \> 100 y/o
2. Pregnant or breastfeeding
3. Allergy to blue dye
4. Locally advanced axillary disease
5. History of receiving neoadjuvant chemotherapy treatment
6. Prior axillary surgery or radiation therapy
Diabetes Prevention Among Post-partum Women With History of Gestational Diabetes

The purpose of the STAR-MAMA intervention is to develop a patient-tailored telephone-base counseling intervention for young Latino women who are at high risk of diabetes. The intervention will focus at the end of pregnancy and the 9 months post-partum period to improve education and behavioral counseling on nutrition and other related health topics .

The following hypotheses will be formally tested:

Compared with controls at 9 months post-partum:

1. Women in the STAR-Moms program will have improved self-reported behavioral outcomes for minutes of physical activity, lower fat diet, and breast-feeding duration (in weeks);
2. Women in the STAR-Moms program will have improved diabetes prevention knowledge;
3. Women in the STAR-Moms program will have increased diabetes-relevant screening rates.

Women in the STAR-MAMA will have lost more weight than women in the control group.

The STAR-MAMA intervention builds on theoretical constructs found in Social Cognitive Theory, Theory of Planned Behavior, and Theories of Social Support found to be effective in weight loss, physical activity and dietary change, based on a recent meta-analysis and other studies. The investigators proposed development of STAR-MAMA will incorporate specific behavior change techniques associated with these theories, including: "self-regulatory" intervention techniques (specific goal setting, prompting self-monitoring, providing feedback on performance, goal review), self-efficacy building intervention techniques (motivational interviewing, using decisional balance and relapse prevention), individual tailoring techniques (information on content and resources), and culturally tailored social support, and which incorporates family needs.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum Latino women (English or Spanish speakers) with history of gestational diabetes.
* 18 years or older

Exclusion Criteria:

* Do not have type 1 or type 2 diabetes.
* Do not have access to phone line or a cellphone to receive weekly calls of health coaching education over the phone.