cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Intermittent Renal Replacement Therapy Using CITRASATE in Critically-ill Patients

Renal Replacement Therapy (RRT) needs an extracorporeal circulation to conduct blood to the dialysis membrane and driving back to the patient. This extracorporeal circulation induces inevitably a risk of coagulation activation and premature clotting of the circuit. Heparin is thereby commonly used to prevent such thrombosis but exposed patient to risk of hemorrhage. This risk of hemorrhage may be important in ICU population, particularly in severe trauma patients.

The calcium is an important determinant of coagulation cascade. The use of specific citrate enriched dialysate without calcium (CITRASATE®) allows to suddenly lower the calcium concentration in extracorporeal plasma, leading to a regional ineffectiveness of clotting and limited heparin needs. This low calcium plasmatic concentration into the extracorporeal circulation has however to be normalized to not generate a systemic hypocalcemia. In our ICU, a local calcium substitution protocol based on dialysate flow is used in clinical practice.

Commonly used in our unit, there is a lack data to evaluate the CITRASATE dialysate in a critical population.

The aim goal of our study will be to assess safety and efficacy of intermittent renal replacement therapy using CITRASATE® in critically-ill patients.

This is a retrospective descriptive study. The included patients will be those who had a Sustained Low Efficiency Dialysis using CITRASATE® dialysate in CHU Lapeyronie in Montpellier, France between 01/01/2019 and 31/12/2021 Using PMSI code, we estimate that 61 patients could be enrolled in this period and each patient could be almost 6 dialysis session. We estimate we could analyzed 300 to 350 sessions. This sample must be confirmed by the opening of medical records.

A data collection will be focused on the RRT parameters, clinical complications until ICU discharge and outcome, extracted from medical records.

The main endpoint will be to determine the prevalence of ionized calcium troubles (hypocalcemia \<0,8 mmol/L or Hypercalcemia \>1,4 mmol/L) per and post dialysis using CITRASATE® with our restitution protocol, and their therapeutic consequences.

The secondary endpoints will be to describe the efficacy of CITRASATE® with our restitution protocol during RRT meant by an optimal dialysis dose and the absence of premature clotting of the circuit.

Eligibility Criteria:
Inclusion criteria:

* Age ≥18 years
* Patient underwent a RRT in the DAR Lapeyronie (CHU Montpellier) between the 01/01/2019 and the 31/12/2021

Exclusion criteria:

* Patient underwent RRT without CITRASATE® protocol
* Lack of data
* Ethical limitation
BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical Activity

Balance control, physical activity and health related quality of life will be assessed before and after a 10 to 12 weeks training program as well as 6 and 12 months thereafter in 200 elderly (\>60) with balance problems (100 with osteoporosis, 100 with Parkinson's disease). Osteoporosis subjects will be assigned to 3 groups (balance training, balance training and Nordic walking, or control group) and Parkinson's subjects to 2 groups (balance training or a control group). The training will be progressive and specific incorporating dual task exercises (directly related to an increased risk of falling). Clinical and laboratory gait and balance measures as well as questionnaires will be used to assess physical function and quality of life. An earlier study, investigating this training program in healthy elderly with balance problems showed that the training was well-tolerated and effective, with a significant increase in balance control, physical function and activity. In this study, we expect that an improvement in balance function, physical activity and health related quality of life, which will lead to a decreased number of falls, prevent and/or postpone incidence of a hazardous fall and thereby reduce the burden on the health care system. Our model for functional balance training and outcome methods will expand techniques and tools available to physical therapists and health care scientist treating and evaluating patients with loss of balance function. Elderly receiving therapy with the goal to improve or recuperate physical function and balance will benefit from this project.


Eligibility Criteria:
* Osteoporosis: To be included the candidate must: be \>65 years with osteoporosis objectively verified by Dual energy X-ray absorptiometry (DXA) in the hip and lumbar back,be an independent ambulator, have experienced at least one fall in the last 12 months and have an adequate medical treatment for their osteoporosis.
* Parkinson's disease: All PD subjects will have a clinical diagnosis of -idiopathic‖ PD (Hoehn \&Yahr scores 2-3), \> 60 years of age and no other existing neuromuscular disorders, including severely flexed posture. In addition, the subjects will have no history suggesting -atypical‖ PD symptoms.

Exclusion criteria's for all subjects are:

* moderate-severe dementia (Mini-Mental score \<24)
* respiratory, cardiovascular, musculoskeletal or neurological (except PD) disorders that may interfere with participation in the exercise program
Convenience, Tolerability, and Safety of Change in the Administration of Rivastigmine From Capsules to a Transdermal Patch in Patients With Mild to Moderate Alzheimer's Disease

This study used two doses of rivastigmine transdermal patch (5 cm\^2, 10 cm\^2) to establish the feasibility of 2 switch schedules (with transdermal patch one-step dose titration or without dose titration) from rivastigmine capsules (3 mg bid (bis in die, twice a day), 4,5 mg bid, 6 mg bid) to rivastigmine transdermal patch and to assess safety, tolerability, convenience, and caregivers preferences of rivastigmine transdermal patch versus capsules.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV (Diagnostic \& Statistical Manual of Mental Disorders, Version IV) criteria for dementia of Alzheimer type and NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association) criteria for probable Alzheimer's disease (AD), have a MMSE (Mini Mental State Examination) score \> 10 and \< 26
* Have received continuous treatment with rivastigmine capsules at least with 3 mg bid (6 mg of total daily dose) for at least 3 months before entering in the study
* Cooperative, willing to complete all aspects of the study, and capable of doing so, either alone or with the aid of a responsible caregiver
* Have a primary caregiver willing to accept responsibility for supervising the treatment, (eg, application and removal of the patch daily at approximately the same time of day) and assessing the condition of the patient throughout the study.

Exclusion Criteria:

* A medical or neurological condition other that AD that could explain the patients dementia (eg, Huntington's disease, Parkinson's Disease, abnormal thyroid function test, B12 or folate deficiency, post-traumatic conditions, syphilis)
* Current diagnosis of an active skin lesion/disorder that would prevent accurate assessment of the adhesion and potential skin irritation of the patch (e.g., atopic dermatitis, wounded or scratched skin in the area of the patch application)
* History of allergy to topical products containing vitamin E
* Taken any of the following substances prior to randomization:

  * succinylcholine-type muscle relaxants during the previous 2 weeks
  * an investigational drug during the previous 4 weeks

Other protocol-defined inclusion/exclusion criteria applied to the study.
Closing the Loop for 36 Hours in Adolescents With Type 1 Diabetes: Evaluation of Reduced Meal Bolusing

The main focus of our research is the development of a closed-loop system for glucose control in people with type 1 diabetes. After having demonstrated the safety and efficacy of overnight closed-loop insulin delivery, we are extending the evaluation of closed-loop to the daytime. Meal-related insulin dosing can be challenging and prandial insulin overdosing can be associated with the occurrence of postprandial hypoglycaemia, thus representing a confounding factor of hypoglycaemia free glucose control during the day. A further investigation is needed to evaluate alternative strategies for prandial insulin dosing. We will study eight adolescents with type 1 diabetes during closed-loop insulin delivery combined with either standard or reduced insulin doses with the meals, in a randomised crossover design. Stable glucose isotopes will be administered to collect data for modelling of glucose turnover around the meals, during daily activities and overnight.

The information provided by the use of glucose isotopes would be very helpful to increase our understanding of the physiology of glucose turnover and to facilitate the development of an improved control algorithm. Ultimately this study will help with the development of a closed-loop system to match insulin infusions to change in glucose levels in real life conditions.


Eligibility Criteria:
Inclusion Criteria:

* The subject is between 12 and 18 years of age (inclusive).
* The subject has had type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative.
* The subject will have been on insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment.
* HbA1c ≤ 12 % based on analysis from central laboratory

Exclusion Criteria:

* Non-type 1 diabetes mellitus including those secondary to chronic disease
* Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
* Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
* Known or suspected allergy against insulin
* Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the clinician
* Total daily insulin dose \>= 2 IU/kg
* Post-menarchal girls who are pregnant or intending to become pregnant or are breastfeeding
* Any coexisting cardiac and respiratory condition
Effects of Rosiglitazone on Serum Ghrelin and Peptide YY Levels

We aimed to evaluate the effects of rosiglitazone on serum ghrelin and peptide yy levels in diabetic women.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed, drug naive women with type 2 diabetes

Exclusion Criteria:

* presence of severe cardiovascular disease (eg, New York Heart Association class III or IV congestive heart failure or a history of myocardial infarction or stroke)
* presence of thyroid, pituitary, nutritional, hepatic, renal, or neoplastic disorders
Effect of Sport Education in University Required PE on Students' Perceived Physical Literacy and Physical Activity Level

This project examines the effects of implementing sport education model in university required physical education lessons on perceived physical literacy and physical activity levels of the students.

Scholars suggested the practical application of sport education could operationalize physical literacy that some features of this pedagogical model are positively associated to the development and attributes of physical literacy. However, there is no further supplement on the curriculum and pedagogical method for physical educators to develop students as physically literate individuals. Compared to primary school students and adolescents, university students are at the stage of transition from compulsory physical education in secondary school to more self-initiated physical lifestyle in adulthood. It is therefore important that they develop physical literacy as well as a positive attitude towards physical activity. Unfortunately, despite its importance, physical literacy among university students is insufficiently investigated. In view of the above, this study employs a cluster randomized trial design to examine the effectiveness of sport education model delivered in the required physical education lessons at the university level to eligible students. The investigation focuses on the pre- and post-test and follow-up difference to see whether there are differences on perceived motivational climate, situational motivation, and their corresponding outcome of perceived PL, PA enjoyment and, self-report and objective PA levels. Also, this study investigates the fitness instruction time by videotaping and coding during every PE lesson from both groups. This study would be significant that the findings could establish the importance on physical literacy development through sport education model as well as develop students' physical literacy and positive attitude towards physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Physical education classes: universities in Hong Kong which are funded by the University Grants Committee and provides required PE lessons.
* Lecturers: graduated from master's degree or above, more than 5 years of teaching experience, in addition with the attendance of 12-hour continuing professional development workshop on Sport Education curriculum.
* Students: aged 18 or above, enrolled in 1-credit required physical education lessons and indicated all statements negatively in the self-screening Physical Activity Readiness Questionnaire (The Canadian Society for Exercise Physiology, 2017).

Exclusion Criteria:

* did not wish to participate;
* have currently used their own wearable activity tracker;
* indicated any major physical, psychiatric, or cardiovascular-related problems diagnosed by a physician.
Risk Factors for Potential Drug -Drug Interactions: Study in Surgical Intensive Care Unit -Zagazig University Hospitals.

Drug drug interactions is frequent in critically ill patients due to polypharmacy, different drug groups and prolonged ICU or hospital stay

This cross sectional study was conducted in Surgical ICU, zagazig University Hospital for 6months period.

Demographic data (age, gender),clinical history data (main diagnosis, ICU stay in days, transfer from emergency room or other departments, on mechanical ventilation or not, state of consciousness

Eligibility Criteria:
Inclusion Criteria:

* all patients admitted to Surgical ICUs for six months period

Exclusion Criteria:

* less than one day admission to ICU,not completed data
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/ Postoperative Ileus

Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).

Postoperative ileus (POI) is a temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. This functional impairment persists for a variable duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged POI, and increases the risk for related morbidity. No drug therapy has been shown to consistently shorten the duration of POI. This study is designed to demonstrate that alvimopan, a novel, peripherally acting mu opioid receptor antagonist, accelerates the recovery of GI function in patients undergoing bowel resection or hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for a partial small/large bowel resection with primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy
* Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids

Exclusion Criteria:

* Subject is scheduled for a total colectomy, colostomy, ileostomy
* Subject has complete bowel obstruction
* Subject has recently been on an acute course (1-10 days) of opioid analgesics and has not been off all opioids for at least 1 week prior to surgery Subject has been on chronic (\>10 days) opioid analgesics and has not been off all opioids for at least 2 weeks prior to surgery.
Diet Modification and Blood Pressure in Young People

To determine the effects of diet modification on blood pressure, blood cholesterol, and bone density in healthy young people.

BACKGROUND:

An inadequate dietary intake of calcium has been postulated to be a factor in the development of essential hypertension, and has long been considered important in the development of osteoporosis among women. Furthermore, animal experiments and limited studies in humans suggest that an increase in the intake of calcium may also have a beneficial effect on blood cholesterol levels. Despite limitations in the research data supporting its benefits, increased calcium intake is being widely advocated to the public and calcium-enriched products are being increasingly purchased and consumed by Americans. The study measured the effects of a modest increase in calcium intake, such as that currently advocated to the general public.

Previous work in the study measured the effects on blood pressures of variations in the dietary intake of sodium and linoleic acid in adolescents at the two New England boarding schools of Phillips Exeter Academy and Phillips Andover Academy. During the first year, dining room food at one school was prepared with 50 percent less sodium; total intake of sodium by students including dining hall food, outside food and snacks was reduced by approximately 35 percent. The other school served as the control. During the second year, the intervention took place at the second school. During the third and fourth years, sodium intake was kept at usual levels while changes were made in food preparation to double the polyunsaturated fatty acid intake from four percent to eight percent of dietary calories. Food diaries, duplicate food samples, and 24-hour urine collections by approximately 200 students at each school were used to monitor dietary modification and student compliance. Weekly blood pressure measurements were performed on the 200 students at each school.

DESIGN NARRATIVE:

A number of food products were modified to increase the dietary intake of calcium by an average of 500 mg/day. Calcium-enriched foods were served alternately for one school year at each of two colleges. Similar products without added calcium were served during the alternate year. It was postulated that, at the end of the school year, students at the intervention school would have lower systolic blood pressure, lower blood cholesterol, and increased bone density than students at the control school.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes

People with high blood pressure and diabetes often have low levels of key nutrients as a result of not eating enough fresh fruits and vegetables. Research studies suggest that these nutrients can lower blood pressure and blood sugar. This study will investigate if providing encouragement to adopt this healthy and nutritious way of eating and providing guidance on weight management will lower blood pressure and blood sugar. The DASH-Life research study will recruit adults with hypertension and type 2 diabetes who live in Baltimore metro areas that don't have many stores selling healthy foods. The DASH-Life research study is 6 months long. Participants will be randomly assigned to one of two groups: 1) Self-Shopping DASH (S-DASH) diet advice group, or 2) Coaching DASH (C-DASH) diet advice group.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diabetes Mellitus Type 2 defined by: self-reported type 2 diabetes diagnosis, or HbA1c\>=6.5%, or treatment of diabetes with diabetes medications(s)
* Baseline systolic BP 120-159 mmHg (with or without medications.)
* Serum potassium level \>3.0 and \<5 mmol/L,
* Estimated glomerular filtration rate (eGFR) \>=45 mL/min/1.73m2.
* Willing and able to complete required procedures in English.
* Living in Healthy Food Priority Area in Baltimore; the US Department of Agriculture (USDA) defined low income, low access areas, or census blocks with area deprivation index (ADI) 60 and above (State Decile\>=6.)

Exclusion Criteria:

* Hypoglycemia requiring hospitalization or the assistance of another person in the last 6 months
* Cardiovascular event within 6 months
* On diabetes or weight loss medications such as glucagon-like peptide 1 (GLP-1), GLP-1/glucose-dependent insulin-releasing peptide (GIP), insulin, or any combination of these medications
* HbA1c ≥ 10%
* Type 1 diabetes
* Baseline systolic BP \< 100 mmHg
* Weight \>400 lbs due to the maximum weight on study scale
* Chronic disease that might interfere with trial participation
* Current participation in another clinical trial that might affect blood pressure, weight loss, diabetes, or ability to adhere to study procedures
* Current participation in program with conflicting dietary guidance (i.e., meal replacement or keto diets)
* Unwillingness or inability to adopt a DASH-like diet
* Planning to leave area in the next 6 months
Chemoprevention of Cancer in the Lower Female Genital Tract: The Antineoplastic Activity of the Fungicide Ciclopirox.

The purpose of this study is to determine if regular and daily repeated application of the ciclopirox lotion to vulva will make the precancerous lesion(s) shrink or even disappear.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages 18 and 75 years.
* Patients may be carriers of the Human Immunodeficiency Virus (HIV).
* Patients must have been diagnosed with precancerous lesion(s) of the vulva by tissue sampling (biopsy-proven vulvar intraepithelial neoplasia grade II or III)
* Patients must be able to come to University Hospital for their initial appointment in Gynecologic Oncology Clinic, and for the eight follow-up visits in that Clinic required by the protocol.

Exclusion Criteria:

* Pregnant or patients who are breast feeding a baby.
* Patients who have been diagnosed with a vaginal yeast infection.
* Patients who have undergone prior surgery for precancerous lesion(s) of the vulva.