cyrilzakka/clinical-trials huggingface dataset:
Preliminary Administration of EPO and Markers of Cardiac Ischemia Induced by CPB

The main objective is to observe the effects of erythropoietin administration on different blood markers of ischaemic cardiac lesions induced by cardiopulmonary bypass.

A new property of erythropoietin (EPO), independent of its hematopoietic role, has recently been discovered. Indeed, it has been reported that this hormone, following binding to its cardiac or cerebral receptors, is able to induce a spectacular cellular protection against ischemic injury. These cardioprotective and neuroprotective effects have been observed experimentally in rodents as well as clinically in humans. In particular, our team has demonstrated that the administration of NeoRecormon® protects the heart against ischemia in the rat by significantly improving its recovery.

In view of these exciting experimental results and of the growing interest of the scientific community for cytoprotective effects of EPO, we are planning the first clinical study examining the cardiac and cerebral protective effects of EPO (NeoRecormon®) in the setting of cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Coronary bypass surgery.
* Surgery not urgent.
* Left ventricular ejection fraction (LVEF) \> 40.
* Informed consent form signed.

Exclusion Criteria:

* Valvular surgery.
* Surgery with beating heart, with or without cardiopulmonary bypass.
* Carotid bypass surgery.
* Myocardial infarction less than 30 days.
* Previous history of cardiac surgery.
* Kidney failure (creatinine \> 200 µmol/l).
* Uncontrolled hypertension.
* Unstable angina.
* Risk of deep venous thrombosis.
* Vascular cerebral attack less than 30 days.
* Malignant tumour.
* Phenylketonuria.
* Allergy to erythropoietin.
* Previous programmed blood donation.
* Pregnancy and feeding.
A Six-week Flexible Dose Study Evaluating the Efficacy and Safety of Geodon in Patients With Bipolar I Depression.

This is a 6-week trial that evaluates the efficacy and safety of Geodon (ziprasidone) in outpatient subjects ages 18 and older with Bipolar Disorder type I, depressed. Subjects are required to undergo a washout period of at least 7 days of any prior med.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode depressed, with or without rapid cycling, without psychotic features, as defined in DSM-IV-TR (296.5X) and confirmed by a structured Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria:

* Subjects with a DSM-IV TR diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder NOS (298.9).
* Subjects with other DSM-IV TR Axis I or Axis II disorder (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6 month period prior to screening.
Staying Connected: a Mobile Health Study With the Noona® and Mobili-T® Systems

Mobile health applications are an attractive technological solution that facilitates access to care for patients conveniently and efficiently. Research has shown that remote mHealth delivery has improved patient reported outcomes of disease severity. While such outcomes have traditionally been collected at one point in time within a clinical setting, the potential exists to now gather patient perspectives remotely. Additionally, when combined with a mobile health device, mHealth apps can objectively monitor a treatment plan.

Before implementing a new technology, it is important to investigate how digital health technologies are best integrated into clinical workflows, and how more than one technology can work together to streamline the process. Additionally, it is important to understand the relative benefits of each system from a user perspective and identify how combined data can benefit clinical workflows. Therefore, the purposes of this project are to demonstrate how two technology companies can work together to assess the feasibility of implementing two related systems into one care pathway.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of head and neck cancer;
* Will be receiving treatment for head and neck cancer (e.g., +/-surgery, +/- radiation therapy, +/- chemotherapy);
* The primary site of their cancer is the oropharynx, as this is the subgroup of patients known to experience dysphagia.

Exclusion Criteria:

* Have a history of cognitive delay,
* History of stroke or traumatic brain injury.
* Have a beard that they are not willing to shave or partially shave (as the device adheres under the chin, on the surface of the skin).
* Have an implanted electronic device of any kind, including cardiac pacemakers or similar assistive devices, electronic infusion pumps, and implanted stimulators
* Have irritated skin or skin with open wounds under the chin;
* Have an allergy to silver.
Exercise Strategies for Bedside Cases During Hospitalization

Patients after hospital admission would experience the functional decline, so-called Hospital-Associated Disability. This condition could not only impact the patient health function but pose a burden on the family, even more consuming of medical resource in the country. Therefore, in addition to routine rehabilitation program, various bedside exercise programs are provided as an adjunct therapy to prevent functional declination and improve physical mobility for a patient after hospital admission. The aims of the study are conducted to compare the effect of three various bedside exercise programs (exercise based on watching video, oral education and paper sheet) on physical mobility among the hospitalized patients.

This is single-blind randomized control study and patients recruited from Tzu-Chi medical center in eastern Taiwan are ranged from 30 to 90 years old. All participants are randomly assigned to three groups (watching video, oral education and paper sheet). Patients in watching video group are provided with theirs 3 to 5 poor physical performance video recorded on the tablet or mobile phone during the rehabilitation program. The other two groups are provided oral education and paper sheet exercise program, respectively. All three groups patients conduct their bedside exercise programs when they return their ward.

Physical performance tests are evaluated before the intervention and one or two days before discharge by a physical therapist blinded the groups of patient .


Eligibility Criteria:
Inclusion Criteria:

1. Functional dependence evaluated by Barthel Index
2. Patients needed to rehabilitation program referred by medical doctor during hospitalization
3. Be able to follow command and assessment

Exclusion Criteria:

1. Impaired cognition
2. Psychological problem from medical diagnosis
3. Having a potential cardiac risk or severe disease diagnosis from medical doctor
Postoperative Biliary Fistula Prevention After Hepatectomy

Aim : Effect of external biliary duct stent after hepatectomy on the occurence of postoperative biliary fistula.

Methods : French prospective multicenter randomized trial. Population study: Adult patients who underwent hepatectomy (\> 2 segments) on non-cirrhotic liver.

Hypothesis: decreased postoperative biliary fistula from 15% to 5% with the presence of a external biliary duct stent. With this hypothesis, the number of patients required to be equal to 152 per group for a total of 304 patients.

Outcome measure: Primary : Postoperative biliary complications (biliary fistula, biloma, biliary peritonitis) Secondary : All morbidity, mortality, additional manoeuvres to treat biliary fistula, during of hospital stay and biliary fistula.

Follow up: A follow-up of patients 3 months after surgery for all patients. The planned total duration of the study is 3 years and 3 months.

After performing the hepatectomy and verification of hemostasis, patients were randomized (external biliary duct stent or not) by sealed envelopes. Systematic intraoperative test with methylene blue or air by the external biliary duct stent (EBDS) will necessary for all patients. Intra-abdominal drainage or not and type will be at the discretion of the surgeon. The EBDS will be left open for the first 7 postoperative days and then clamped. The EBDS will be removed during a consultation 5 weeks after surgery. Both groups of patients will be reviewed at 3 months after surgery, it will be noted at this point the possible complications related to the presence of EBDS (leakage from the drain, drop..). If patients are hospitalized more than five weeks, the study will stop at their consultation three months or the day of the consultation where the DTC is removed if it is still present at 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Subject has given his informed consent and signed consent
* Hepatectomy at least 2 segments of liver parenchyma for a benign or malignant disease by laparotomy
* Not cirrhotic liver

Exclusion Criteria:

* Surgery made in emergency
* Surgery by laparoscopy
* Need to draw up a bilic-digestive anastomosis
* Liver cirrhosis
* History of cholecystectomy
* Resection of less than 2 segments
* Preoperative jaundice (total bilirubin\> 30 micromol / l)
* Presence of preoperative biliary drainage
* Patients requiring the installation of a drain transcystic during the operation
Fiasp® Versus NovoRapid® in Children With Type 1 Diabetes on MiniMed 640G Pump With Sensor

This is an exploratory, single-center, open label, randomized, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoRapid® when used in the Medtronic MiniMed 640G system in pediatric subjects with Type 1 Diabetes Mellitus

This study is designed to compare Fiasp® to NovoRapid® in children with T1DM wearing MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter in terms of glycemic control with a focus on post-prandial ½-hour and 1-hour plasma glucose levels. The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period.

Half, randomized subjects will have a 4 weeks screening period using NovoRapid® and then 4 weeks treatment period with Fiasp® whereas the rest of the participants will start the trial period with 4 weeks using Fiasp® followed by 4 weeks in NovoRapid®.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained by parents or legal caregivers before any trial-related activities.
2. Any age, age ≥ 2 years and age \<18 years at the time of signing informed consent
3. Documented diagnoses of T1DM ≥ 3 months prior to the beginning of the study
4. Using the Medtronic MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter for at least 30 days prior to beginning of the study and willing to continue using the system throughout the trial.
5. Ability and willingness to use the same insulin infusion sets throughout the trial
6. Using the same insulin for at least 30 days prior to screening
7. HbA1c \< 9.0% as assessed by local laboratory at screening
8. Ability and willingness to adhere to the protocol including performing SMBG (Self Monitoring Blood Glucose) profiles, attending visits, uploading pump and sensor data to the CareLink platform

Exclusion Criteria:

1. Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies
2. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within 30 days before screening
3. Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial
4. Any diabetic complication including renal disease, retinopathy, etc
5. History of hospitalization for ketoacidosis ≤ 3 months prior to the day of screening
6. Any condition which, in the opinion of the Investigator, might influence patient's safety or compliance with the protocol
Perioperative Rehabilitation Therapy in Patients Undergoing Liver Transplantation

Patients undergoing liver transplantation frequently experience a reduction in skeletal muscle mass, malnutrition, and decreased levels of physical activity. These complications can adversely affect early postoperative recovery and the therapeutic effect of the transplant. This clinical study aims to investigate the effects of nutritional supplementation and rehabilitation therapy on sarcopenia associated with liver transplantation in adults. The goal is to establish a comprehensive perioperative intervention strategy to reduce the incidence of postoperative sarcopenia and improve transplantation outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 70 years.
2. Patients with end-stage liver disease who meet the criteria for liver transplantation (for liver cancer cases, only recipients meeting specific standards are included).
3. Complete clinical information, including documented pre-transplant muscle status (e.g., preoperative CT scans and handgrip strength tests).
4. High compliance with treatment, fully capable of independent action or having at least one assistant.
5. No contraindications to the planned interventions.

Exclusion Criteria:

1. Presence of musculoskeletal disorders before transplantation, such as myositis, idiopathic muscle atrophy, or history of hip surgery within the past three months.
2. Coexisting severe cardiovascular or cerebrovascular diseases, infectious diseases, or epilepsy.
3. Liver transplantation due to autoimmune liver disease or drug-induced liver failure.
4. Re-transplantation, multi-organ transplantation, living donor liver transplantation, split liver transplantation, or pediatric liver transplantation.
5. ABO-incompatible liver transplantation.
6. Incomplete clinical information.
7. Difficulty in follow-up.
Assessing the Effectiveness of Concurrent Peer Review for Patients With Cardiovascular Disease and Diabetes

We will assess the impact of concurrent peer review vists on blood pressure, cholesterol and diabetes control. Concurrent peer review (CPR) visits refer to special offic visits by patients to a clinician (physician, nurse practitioner, or physician assistant) other than than their primary care provider that are specifically designed to improve care for diabetes and cardiovascular disease.

This project aims to reduce racial and ethnic disparities in health care by improving cardiovascular and diabetes management among poor and minority patients. We propose to implement and evaluate an innovative, but practical intervention: CPR visits. CPR visits are designed to minimize competing demands for clinicians and reduce clinical inertia by focusing clinician and patient attention on optimizing cardiovascular and/or diabetes management and disease control and through use of clinician prompts and decision support at the point of care. Following training of clinician staff, CPR visits will be implemented within two sites of a single community health center (Westside Health Services, Inc). Patients will be randomly assigned one CPR visit with a clinician other than their primary care clinician or to usual care. The primary study outcome will include control of hypertension, diabetes, and lipids. Secondary outcomes will include process measures for cardiovascular and diabetes care. Both personnel and data collection infrastructure will build on the existing Health Disparities Collaborative at Westside. A research team from the University of Rochester will assist in the implementation of study design. This team will lead both the quantitative and qualitative evaluation of the project including outcome and process measures. Project findings offer promise for improving care to underserved populations through dissemination and implementation of a feasible strategy among practices caring for the underserved. Findings will be disseminated nationally in conjunction with the Robert Wood Johnson Foundation, the National Association of Community Health Centers, and the National Health Disparities Collaborative and through publication in the peer reviewed literature and presentation at national conferences.

Eligibility Criteria:
Inclusion Criteria:

* Active patient at Westside Health Services.
* Currently enrolled in the Health Disparities Collaborative at WHS.
* At least one visit to primary care provider in past year.
* Any of the following documented during the preceding three months:
* BP not at goal e,g. (BP 140/80 or greater unless has DM, CAD or CRI then BP greater than 130/80), LDL-C not at goal (level dependent on absolute ATP III CVD risk) or glycated hemoglogin 7 percent or higher

Exclusion Criteria:

* Less than 18 years of age
Regenerative Potential of Advanced Platelet Rich Fibrin and Bioactive Glass (Perioglas®).

The aim of this study is to evaluate and compare the regenerative potential of Advanced Platelet Rich Fibrin (A-PRF) and Bioactive Glass (Perioglas®) bone graft in the treatment of intrabony defects in chronic periodontitis patients.

45 sites with vertical intrabony alveolar defects will be selected. These defect sites will be allocated randomly into 3 groups as Group I, Group II and Group III.

* Group I will be treated with open flap debridement and filled with A-PRF
* Group II will be treated with open flap debridement and filled with Bioactive glass (Perioglas®)
* Group III will be treated with open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF.

Eligibility Criteria:
Inclusion Criteria:

* Age: 25 to 55 years.
* Gender: Both males and females will be included in the study.
* Co-operative and motivated patients committed to oral hygiene.
* Patients exhibiting intrabony defects.

Exclusion Criteria:

* Patients with contraindication to periodontal surgery \& local anesthesia.
* Any systemic disease affecting the bone density and outcome of periodontal therapy.
* Smokers, alcoholics, and patients with other adverse habits.
* Pregnant, nursing and menopausal women.
* Any known allergy/ hypersensitivity to any product used in this study.
* Patients on long-term systemic therapy (antibiotics, anti-inflammatory bisphosphonates, hormonal replacement therapy and any other), taking any drug known to have periodontal implications that may interfere with wound healing.
* Patients taking any anti-platelet and anticoagulant medication.
* Patients who have undergone periodontal treatment within a period of past 1 year.
A Study of Sodium Oligomannate (GV-971) in Participants With Mild to Moderate Alzheimer's Disease

The purpose of this study is to evaluate the safety, tolerability and efficacy of GV-971 in mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate AD per NIA-AA.
* History of cognitive and functional decline over at least 1 year.
* MMSE scores between 11 and 24 (inclusive) at baseline.
* Brain MRI scan show the highest possibility of AD.
* Have a study partner/caregiver.

Exclusion Criteria:

* Diagnosis of a dementia-related central nervous system disease other than AD.
* Major structural brain disease as judged by MRI.
* A resting heart rate of \< 50 beats per minute (bpm) after 5 minutes of rest in sitting or supine position.
* Major medical illness or unstable medical condition within 6 months of screening.
* Concomitant use of AChEIs and/or memantine within 30 days before first MMSE score, and during the study.
* Inadequate hepatic function.
* Inadequate organ and marrow function.
* ECG clinically significant abnormalities.
A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures

The purpose of this study was to evaluate the safety and pharmacokinetics of LCM syrup in children ages from 1 month to 17 years with uncontrolled partial seizures when added to 1 to 3 other antiepileptic drugs (AEDs).

Six subjects aged 5-11 (Cohort 1) were initially enrolled at the 8 mg/kg/day dose level. Upon completion of the study for these subjects, pharmacokinetic and safety data were analyzed to determine the target dose for the remaining subjects (either 8, 10 or 12 mg/kg/day). Depending on the selected target dose, four additional age-based cohorts of subjects were to be enrolled. LCM was increased 2 mg/kg/day per week until the target dose or maximum dose able to be tolerated was achieved.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female between 1 month and 17 years of age inclusive
* Subject's Body Mass Index (BMI) is within the 5th to 95th percentile for his/her age group
* Subject has a diagnosis of epilepsy with partial-onset seizures
* Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment with at least 2 anti-epileptic drugs (AEDs) (concurrently or sequentially)
* Subject has been observed to have at least 2 countable seizures in the 4-week period prior to Screening
* Subject is on a stable dosage regimen of 1 to 3 AEDs

Exclusion Criteria:

* Subject is currently participating or has participated within the last 2 months in any study of an investigational drug or experimental device
* Subject with seizures that are uncountable due to clustering during the 8-week period prior to study entry
* Subject is on a ketogenic or other specialized diet
* Subject has a history of primary generalized epilepsy
* Subject has a history of status epilepticus within the 6-month period prior to Screening
* Subject is receiving concomitant treatment with felbamate or has received previous felbamate therapy within the last 6 months prior to Screening
* Subject has taken or is currently taking vigabatrin
* Subject is taking monoamine oxidase (MAO) inhibitors or narcotic analgesics
* Subject has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months