cyrilzakka/clinical-trials huggingface dataset:
Dysautonomia in Patients Post COVID-19 Infection

The aim for this study is further to elucidate the presence of dysautonomia in post-covid-19 patients, by evaluating heart rate variability.

The COVID-19 pandemic is currently a serious global public health concern. This disease is caused by a novel coronavirus which was first discovered in Wuhan, China in 2019 and later spread rapidly throughout the world. Symptoms of the disease can manifest as fever, cough, encephalitis, myalgia, fatigue, muscle weakness, arthralgia, anosmia, and impairment in other bodily functions in the acute phase. In 17% to 67% of cases, COVID-19 patients will develop acute respiratory distress syndrome (ARDS) and critical illness. Besides the impact on the respiratory system, coronaviruses have an effect on other systems including the central nervous system, cardiovascular system, musculoskeletal system, and gastrointestinal system.

Potential long-term secondary effects on the musculoskeletal system such as muscle weakness, decreased muscle mass, and myopathies have been brought under attention. Persisting symptoms in patients recovered from COVID-19 infection are frequently a complaint with at least 1 symptom, particularly fatigue and dyspnea. In recent papers, the authors commented on the potential role of dysautonomia in the post-covid-19 entity related to microangiopathy and endothelial injury. Such lesions were already reported in brain biopsy samples of severe COVID-19.

Therefore, the aim of this study is further to elucidate the presence of dysautonomia in post-covid-19 patients, by evaluating heart rate variability.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosed covid-19 infection that took place 2-8 weeks before study inclusion.
* Cognitive and language functioning enabling coherent communication between the researcher and the participant.
* French-or Dutch speaking persons.

Exclusion Criteria:

* Covid-19 infection \> 8 weeks ago.
* The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus)
Expression of ANXA2 in the Extracellular Space in the Microenvironment of Periumoral Edema Promotes Glioma Invasion

The prognostic value of ANXA2 expression in tumor tissue and PTBE was analyzed, so as to seek new therapies to inhibit glioma invasion and improve the prognosis of glioma patients

The main reason for the poor prognosis of glioma is the invasion of tumor cells along the extracellular space (ECS) in the periatumoral edema zone (PTBE).Previous studies have shown that ANXA2 is highly expressed in glioma and promotes tumor growth and invasion, while its expression in the PTBE microenvironment of glioma and its mechanism of action on tumor invasion have not been reported.Previous study found that ANXA2 was overexpressed in gliomas and was associated with poor prognosis, and the low expression of ANXA2 significantly inhibited tumor invasion in vitro.Relevant studies have also confirmed that as an exocrine protein, it mainly plays a role in ECS, and it has previously been carried out on the tissue structure of ECS in tumor microenvironment.Therefore, investigators planned to study the mechanism of ANXA2 expression in PTBE microenvironment ECS on tumor invasion.This project aims to take glioma related issues as the research object and analyze tumor tissue and tumor tissue

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone microneurosurgical resection of the tumor in our hospital and are pathologically confirmed to be supratentorial glioma;
* Preserving the remaining tissue samples of paired gliomas and PTBE for pathological examination;
* The patients agreed to be enrolled and signed the informed consent;
* The clinical data of the patients are complete and not lost;
* No serious complications occurred after surgery.

Exclusion Criteria:

* All glioma patients who did not meet the inclusion criteria
Parenchyma Resection of Cirrhotic Liver by the Clamp Crushing Technique and the Ultrasonic Dissector

To identify the most efficient parenchyma transection technique for cirrhotic liver resection between the clamp crushing technique and the ultrasonic dissector.

Primary endpoint is intra-operative blood loss during liver transection (ml). Expected results and implications: If one of the technique is better than the other, surgical teams could prefer it to minimize the morbidity of liver resection in cirrhotic patients.

Design Multicentric randomized controlled simple blinded trial comparing the clamp crushing technique vs. the ultrasonic dissector. The trial will last 24 months with 21 month-inclusion time.

Patients Patients will be enrolled in 5 university hospitals in Ile de France. Eligibility criteria include adults with Child A liver cirrhosis undergoing partial hepatectomy (≥ 1 liver segment). Exclusion criteria include non cirrhotic patients, Child B or C cirrhosis, portal hypertension and laparoscopic hepatectomy.

Sample size calculation was performed with the expectation of a 250 ml (one red cells pack) difference in blood loss during parenchyma transection with a level of statistical significance of 0.05 and a power of 0.80. These calculations indicated to include at least 60 patients in each group.

Secondary endpoints include blood loss standardized to the transection area (ml/cm²), free margins around the tumor, postoperative liver ischemia-reperfusion injury and postoperative complications.

Course of the study An informed consent will be obtained from each patient prior to surgery. Each patient will be randomized the day prior to surgery. As usual, each patient will be followed daily until he will discharge (10 days) and for 2 months at the postoperative outcome patient clinic, which will end the study period for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Child A liver cirrhosis
* Partial hepatectomy (≥ 1 segment).
* Patient at least 18 years of age

Exclusion Criteria:

* Non cirrhotic patient
* Child B or C cirrhosis
* Portal hypertension
* Laparoscopic hepatectomy.
Incidence and Clinical Course of Colonoscopy Related Perforation

This study aims to investigate the incidence and clinical course of colonoscopy related perforation based on the result of a prospective registry.

In each endoscopy unit from participating hospital, there is a alarm system focusing on the development of perforation. Therefore, perforation cases will not be missed from the registry.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a perforation after colonoscopy

Exclusion Criteria:

* Patients who refuse to be registered.
A Single Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Orally Administered DAA-I in Healthy Subjects

This is a placebo-controlled randomized phase 1 study to investigate the safety and pharmacokinetics of DAA-I in a cohort of healthy subjects.

The study will be a single-blind, step-wise dose escalation, placebo controlled study in healthy subjects consisting of up to 3 dose steps of DAA-I. In the sequential step wise design, a single dose of DAA-I or placebo will be administered to 6 subjects for one treatment group. For each dose step, 4 subjects will receive DAA-I and 2 subjects will receive placebo. Subjects will be randomly allocated to one dose step. Step One would have to be completed before Step Two. Escalation up to Step Two and subsequent steps would depend on the safety results from the preceding step(s). There will be an interval of 6 hours between the dosing of the first and second DAA-I-treated volunteers of each cohort to allow for early cardiovascular monitoring. Only if there are no safety signals identify from these subjects as assessed by the Safety Review Committee can simultaneous dosing of the remaining volunteers be carried out.

Eligibility Criteria:
Inclusion Criteria:

1. Overtly healthy males or females as determined by medical history and physical examination.
2. Between the ages of 21 and 50 years, inclusive.
3. Weight limits within range of Body Mass Index (BMI) 19-30kg/m2
4. Renal, hepatic and blood chemistry results within normal range.
5. Normal blood pressure and heart rate as determined by the investigator.(Normal range: Systolic BP 100-140mmHg;Diastolic BP 40-90mmHg; Heart rate 50 - 100 beats per minute)
6. Temperature between 36oC to 37.4oC
7. Electrocardiogram considered as within normal limits by the investigator.
8. Are reliable and willing to make themselves available for the duration of the study.
9. Ability to provide informed consent.

Exclusion Criteria:

1. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, neurological disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication.
2. Evidence of significant active haematologic disease and/or blood donation in the last 3 months.
3. Are pregnant or intend to become pregnant during the course of the study.
4. Sexually active women of childbearing age not actively practising birth control by using oral contraceptives or an intrauterine device (IUD).
5. Women who are lactating.
6. History of allergic reactions to angiotensin inhibitor (AI), angiotensin II inhibitors, DAA-I or other relevant allergic reactions of any origins.
7. Participation in a study involving administration of an investigational compound within the past 30 days.
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)

This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 230 study sites in the US and Canada and up to 35 sites outside of North America will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD
* Age from 50 to less than 89
* Mini-Mental Status Exam score of 16-26 inclusive
* Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
* Stable doses of medications (cholinesterase inhibitors and memantine allowed)
* Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

* Significant neurological disease other than AD
* Major psychiatric disorder
* Significant systemic illness
* History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
* Smoking greater than 20 cigarettes per day
* Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
* Prior treatment experimental immunotherapeutics or vaccines for AD
* Women of childbearing potential
* Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
Effectiveness and Cost-effectiveness of a Telemonitoring Program for Diabetic People at Home

Severity of diabetes is related to the development of disabling and costly complications (12.9 billion euros in 2007). The French High Health Authority recommends a therapeutic education on lifestyle and dietary rules in first-line treatment of Type 2 Diabetes Mellitus. Despite these recommendations, patients often have difficulties to implement dietary recommendations every day. The objective of EDUC@DOM is to help people with diabetes to improve lifestyle and equilibrium of glycaemia in order to avoid or delay chronic complications of diabetes. Our main goal is to assess effectiveness of our telemonitoring program in type 2 patients' care compared to a usual care of diabetes, on the glycaemia of the patients. It is expected that our program leads to a better monitoring of health status, a greater adherence to medical and non-medical prescriptions, an empowerment of the patient, and as a consequence, a more efficient health care consumption.


Eligibility Criteria:
Inclusion Criteria:

* Patient with type 2 diabetes
* Older than 18 years
* With an insulin treatment or not
* Having a glycemic impairment characterized by 6.5% \<HbA1c ≤10
* Having an active internet connection at home.
* Accepting the terms of training, loan and use of the device
* Benefiting from social protection system
* Having given his/her free and informed consent and signed the consent

Exclusion Criteria:

* Serious illness recently (\<3 months) or decompensated may influence glycemic control of the patient permanently according to the judgment of the physician in charge of monitoring
* Retinal state that does not allow optimization in equilibrium of glycaemia
* Known severe renal impairment defined by creatinine clearance \<30ml/min
* Known hemoglobinopathy
* Visual or intellectual resulting inability to use the remote monitoring tool according to the judgment of the physician in charge of monitoring
* Inability to understand all or part of the software information according to the judgment of the physician in charge of monitoring
* Subject to disabled
* Person with severe behavioral disorders (anorexia, bulimia, ...) according to the judgment of the physician in charge of monitoring
* Person who had, or in preparation for bariatric surgery (software nutrition education are not suitable for this type of care.)
* Person with a medical device implanted electronic pacemakers and defibrillators with cardiac (possibility of interference with the impedance)
* Another person involved in research including a period of ongoing exclusion to inclusion,
* A person under legal protection
* Subject living in institutions
* Desire for pregnancy, pregnancy or breastfeeding
ProQuad® Intramuscular vs Subcutaneous

Primary objective:

To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of ProQuad®

Secondary objectives:

* To describe the antibody response rates to measles, mumps, rubella and varicella measured 30 days following the first dose of ProQuad® administered by IM or SC route,
* To describe the antibody titres to measles, mumps, rubella and varicella at 30 days following the first dose and at 42 days following the second dose of ProQuad® both administered by IM or SC route,
* To describe the safety profile of two doses of ProQuad® both administered by IM or SC route.


Eligibility Criteria:
Inclusion Criteria:

* Healthy participant of either gender,
* Age 12 to 18 months,
* Negative clinical history of measles, mumps, rubella, varicella and zoster,
* Consent form signed by both holders of the parental authority or by the legal representative
* Holder(s) of the the parental authority / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

* Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,
* Any recent (≤30 days) exposure to measles, mumps, rubella, varicella and/or zoster
* Any recent (≤3 days) history of febrile illness
* Any severe chronic disease,
* Active untreated tuberculosis,
* Known personal history of seizure disorder,
* Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
* Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
* Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid \[any long-term (≥14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (≥2 mg/kg/day prednisone equivalent or ≥20 mg/day if weight more than 10 kg) within the previous 30 days\] or other immunosuppressive therapy,
* Any previous (≤ 150 days) receipt of immune globulin or any blood-derived product or scheduled to be administered through Visit 3,
* Any recent (≤7 days) tuberculin test or scheduled tuberculin test through Visit 3,
* Any recent (≤30 days) receipt of an inactivated or a live vaccine or scheduled vaccination through Visit 3,
A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women

The purpose of this study is to examine the effect of two different dose levels of estrogen or placebo in healthy postmenopausal women by measuring the changes in hormone levels and examining the changes in the uterine lining (endometrium).


Eligibility Criteria:
Inclusion Criteria:

* Patient is a healthy postmenopausal woman less than or equal to 65 years of age with onset of menopause less than or equal to 10 years prior to prestudy visit 1
* Patient has a uterus and no history of uterine bleeding in the past 3 months
* Patient has not had a previous endometrial biopsy within the last 4 weeks
* Patient has had a normal mammogram within the last 11 months
* Patient has had a normal pap-smear within the past 3 years prior to screening
* Patient has had a normal transvaginal ultrasound of the endometrium
* Patient is willing to avoid strenuous physical activity such as strenuous or unaccustomed weight lifting, running, bicycling, etc for the duration of the study
* Patient agrees to not consume grapefruit products beginning approximately 2 weeks prior to the first dose of study drug and throughout the study
* Patient agrees to limit daily consumption of alcohol. During the study, daily alcohol consumption should not be more than 2 glasses
* Patient agrees to limit daily consumption of caffeine. During the study, daily caffeine consumption should not exceed 3 cups of coffee
* Patient is a non-smoker

Exclusion Criteria:

* Patient is mentally or legally incapacitated
* Patient has a history of any first degree relatives with breast or endometrial cancer
* Patient has a history of multiple and/or severe allergies to prescription or non-prescription drugs or food
* Patient has used any type of estrogen or progesterone preparation unless followed by appropriate wash-out periods
* Patient has had surgery, donated approximately 500 mL of blood or has participated in another investigational study within the last 4 weeks
* Patient has a history of deep vein thromboses, coronary artery disease, heart attack or stroke
* Patient is a current user of illegal drugs
* Patient has a history of hypersensitivity to estrogen products
* Patient is unable to refrain from using anti-coagulants
Survey of Symptoms After a COVID Vaccination in Employees

Background:

SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) has had us firmly in its grip for more than two years. In January 2021, the quality and risk management unit of the LKH (Landeskrankenhaus) -Univ. Klinikum Graz commissioned to carry out vaccinations for employees and subsequently for high-risk patients.

In the vaccination line, which was open for 85 days in 2021/22, the vaccines from Astra Zeneca, Biontech-Pfizer and Moderna were vaccinated. There were hardly any complications. The primary immunization, booster vaccination and booster vaccination were carried out.

Despite the small number of incidents in the sense of an immediate reaction, there were numerous sick leave.

Methods:

For this reason, in the course of the booster vaccination, starting from October 2021 to January 2022, every vaccinated person was asked to fill out a questionnaire. Participation was voluntary and was supported by the works councils of the Medical University and the LKH-University clinic Graz approved. The survey served to retrospectively record how many employees developed symptoms in response to the respective vaccination.

With this approach it will be possible to subject the responses to an in-depth statistical analysis in order to obtain a data-based contribution to the side effects of vaccines categorized with different vaccination schemes.


Eligibility Criteria:
Inclusion Criteria:

* Employees with appropriate indication (\>4 months after the second vaccination) according to the recommendations of the national vaccination committee.
* Signed vaccination information sheet.

Exclusion Criteria:

* no booster vaccination.
Health, Fitness, and Quality of Life in Adolescent Girls With Turner Syndrome

This study plans to learn more about how the energy system works in girls with Turner syndrome. This is important to know so that the investigators understand how Turner syndrome relates to diseases such as diabetes, extra weight gain, heart disease and liver disease, and how this impacts day to day life.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 12-21 years
* 45,XO karyotype in \>50% of cells tested with a diagnosis of Turner syndrome (TS)
* Tanner stage 2-5 for breast development

Exclusion Criteria:

* Growth hormone treatment within the past 3 months
* Diagnosis of type 1 or type 2 diabetes
* Untreated hypertension with blood pressure \> 99%ile for sex, age and height or \>140/90
* Weight \> 300 lbs
* Height \< 54"
* Aortic sinus of Valsalva or ascending aorta z-score \> 2
* Other cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures, including vigorous exercise
* Pregnancy