cyrilzakka/clinical-trials huggingface dataset:
A Study for Patients With Acute Leukemia

This study is a multicenter, nonrandomized, open-label, dose-escalation with intra-patient dose-escalation, Phase 1 study of intravenous LY2523355 to determine the dose of LY2523355 that can be safely administered to participants with acute leukemia. Part A and Part B are dose escalation of two schedules in participants with acute leukemia. Parts A and B will enroll concurrently. Part C is a dose expansion for each schedule in participants with acute myeloblastic leukemia (AML).


Eligibility Criteria:
Inclusion Criteria:

Dose escalation period for both schedules:

* Participants must have a confirmed diagnosis of acute leukemia regardless of sub-type and for whom experimental Phase 1 therapy is appropriate.
* Are greater than or equal to 18 years of age.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.

Dose confirmation period for both schedules:

* Participant must have a confirmed diagnosis of untreated acute myeloblastic leukemia (AML), should not be a candidate for standard therapy, and a clinical trial is a preferred treatment option or have acute AML that is relapsed or refractory to no more than 2 prior induction regimens. Hydroxyurea to control prior blast counts is not considered a prior regimen.
* Are greater than or equal to 60 years of age.
* Have a performance status of 0 or 1 on the ECOG scale.
* Females with childbearing potential must have had a negative urine or serum pregnancy test less than or equal to 7 days prior to the first dose of study drug.

Exclusion Criteria:

* Have received treatment within 28 days of the initial dose of study drug with a drug that has not received regulatory approval for any indication.
* Participants with known central nervous system (CNS) leukemia by spinal fluid cytology or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Participants with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment.
* Have other active malignancy (with the exception of basal and squamous cell skin cancer) at time of study entry.
* Have had an autologous or allogenic bone marrow transplant within 3 months. All organ toxicity must be resolved.
* Have evidence of graft-versus-host disease due to an allogenic bone marrow transplant.
* Have uncontrolled systemic infection.
* Females who are pregnant or lactating.
* Have known positive test results in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb) (screening not required).
Short-term Perioperative Thromboprophylaxis After Major Abdominal Surgery

Major abdominal surgery for cancer is major risk factor for thromboembolism. Patients who undergo major abdominal surgery are prone to develop venous thromboembolism, both in the early postoperative period and after hospital discharger. There are strong recommendations in the international guidelines in favor to pharmacological thromboprophylaxis. Thus there is no consensus dor the duration of the prophylaxis. There are authors that suggest extended prophylaxis up to 4 week after surgery. On the other hand, there are prospective randomized trials that inpatient (short-term up to 7-10 days) prophylaxis is adequate.

This is a retrospective cohort study with 89 patients who underwent major abdominal surgery for colorectal and gastric cancer. All patients received short term prophylaxis (during hospital stay only) rather than extended prophylaxis (4 weeks). All participants received duplex ultrasound in the study period for the diagnosis of deep vein thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18
* Major abdominal surgery gor colorectal or gastric cancer
* Caprini Risk score less than 9
* No history of anticoagulant treatment
* Thromboprophylaxis during hospital stay only

Exclusion Criteria:

* Younger than 18
* Caprini Risk score 9 and above
* History of anticogulants
* Not reachable by phone etc
Observational Study of Somatropin Treatment in Children

GeNeSIS is an open-label, multinational, multicenter, observational study to evaluate the safety and effectiveness of Humatrope treatment.

GeNeSIS is a modular program that includes:

* Core study: Evaluating the safety and effectiveness of Humatrope in the observational setting
* Genetic Analysis Sub-study: Investigating the genetic defects underlying growth hormone (GH) deficiency and non-GH-deficient growth disorders
* Growth Prediction Sub-study: Working to validate and refine specific models to accurately predict growth response to GH
* Short Stature Homeobox containing gene (SHOX) Deficiency Sub-study: Elucidating the clinical, endocrine and radiological features of participants with SHOX deficiency due to loss of, or mutation in the SHOX gene (including participants with Turner syndrome)
* Neoplasia Sub-study: To characterize the natural history of neoplastic disease, especially in relation to recurrence/progression of primary neoplasia or development of secondary neoplasia in children with a history of neoplasia


Eligibility Criteria:
Inclusion Criteria:

All participants participating in GeNeSIS must be enrolled in the core study. Participants for whom written consent to release information is provided may enter the core study if they meet any of the following inclusion guidelines:

* Treatment with Humatrope for improvement of growth.
* No treatment with somatropin in participants with a history of neoplasia or in those with any SHOX deficiency-related disorder.

Exclusion Criteria:

* Participants with closed epiphyses are not eligible for GeNeSIS entry. However, participants may remain in the study if epiphyseal closure occurs during study participation.
Analyses of Cerebrospinalfluid in Patients With Delirium

The current project aims to measure biomarkers in the cerebrospinalfluid (CSF) and serum samples from patients with delirium. We hope to uncover new insights into the pathophysiology of delirium and explore its link to dementia.

Delirium is a common and serious complication to acute illness, and is characterized by acute disturbances in attention, awareness, and cognition. Dementia is a major risk factor of delirium, and delirium increases the risk of dementia progression and development. As the conditions share both clinical and epidemiological features, some researchers suggest that also pathophysiological links are shared. Understanding delirium pathophysiology, which is poorly understood, may thus help elucidate early molecular mechanisms in dementia.

This study aims to to increase our understanding of the pathophysiology of delirium and molecular links between delirium and dementia, by exploring cerebrospinal fluid (CSF) biomarkers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute hip fracture

Exclusion Criteria:

* Moribund patients.
* Lack of consent
Sleep Disturbances as a Risk Factor in Chronic Kidney Disease

This study is designed to determine if either short night time sleep or poor night time sleep could be a risk factor for increasing the rate at which kidney function deteriorates in persons with mild to moderate kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Mild to Moderate CKD
* Healthy controls age and gender matched to CKD subjects
* Regular bedtimes of at least 6h/night, sedentary lifestyle

Exclusion Criteria:

* Diabetes
* Current or previous dialysis for more than 1 month
* Uncontrolled hypertension
* Heart failure
* Liver disease
* HIV
* Hemoglobin \< 10.5 g/dl
* Treatment with EProcrit, Epogen, or Aranesp
* Bone or organ transplant,
* Use of immunosuppressive drugs within past 6 months
* Current oral contraceptive use
* Current pregnancy
* Chemotherapy for malignancy within past 2 years
Effect of Omega-3-fatty Acids on Blood Levels Omega-3 Fatty Acids in Patients With Age-related Macular Degeneration

The effect of omega-3-fatty acids on blood levels omega-3 fatty acids in patients with age-related macular degeneration.

There is observational data in the current literature suggesting that the intake of foods high in marine sources of omega-3 fatty acids, such as fish, may lower the risk of developing age-related macular degeneration (AMD). A large prospective study is underway to determine whether oral supplementation with 1 gram of omega-3 fatty acids is beneficial for subjects with dry AMD. The purpose of our study is to evaluate the change in serum omega-3 index (blood level of omega-3 fatty acids) after 1 gram of omega-3 fatty acid supplementation versus 2 grams.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Have AREDS category 3 or 4 disease.
* Category 3: Many medium sized drusen or one or more large drusen in one or both eyes
* Category 4: Geographic atrophy or choroidal neovascularization in one eye.

Exclusion Criteria:

* Women of child-bearing age with positive urine pregnancy tests or desire to conceive during the course of the study.
* Patients with a known fish allergy.
* Patients currently taking supplementation with omega-3 fatty acids and have an omega-3 index of greater than 4%.
The Effect of Desfluran On Global Dna Methylation

The purpose of this study is to demonstrate the molecular effect of desflurane on DNA by measuring the global DNA methylation level in patients under going lumbar spinal stenosis surgery under general anesthesia.

Forty patients scheduled for lumbar spinal surgery will include in the study. Peripheral venous blood samples will collect prior to the induction of anesthesia (T1) and after 120 minutes (T2). Anesthesia will maintaine with 40%-60% O2-air mixture and 6% desflurane. DNA will obtain from blood samples with the help of DNA isolation kit and global DNA methylation analysis will perform by ELISA method.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and willingness to sign an informed consent form
2. Elective lumbar spinal surgery that will take at least 120 minutes,
3. American Society of Anesthesiologists (ASA) physical status I and II
4. Be between the ages of 18 and 65

Exclusion Criteria:

1. Patients with ASA physical status III or IV disease
2. Smoking or alcohol consumption
3. Chronic systemic disease (diabetes mellitus,chronic pulmonary disorders, chronic kidney and liver disorders
4. recently received radiation, chemotherapy
5. malignancy
6. blood transfusion in operation
7. use of antioxidant supplements
8. have received general anesthesia in the last three months
9. Patients with known occupational exposures (operating room personnel, chemical plant workers
Nutritious Eating with Soul Dissemination and Implementation

The investigators will conduct a full dissemination and implementation study using a type 2 hybrid effectiveness-implementation design. The investigators will conduct this study in the community and work with two vegan soul food restaurants. The investigators propose to examine the effectiveness and implementation of community-delivered, 3-month NEW Soul program among participants (N=228).

Using a randomized design, the investigators will assess effectiveness of two delivery approaches: (1) In-person, live weekly classes with restaurant vouchers (intervention) or (2) restaurant voucher-only (active control).

The investigators will also conduct a cost-effectiveness analysis of delivering the online intervention plus voucher vs. voucher-only with the outcome of cost/change in weight, healthy eating index, and quality adjusted life year.

Lastly, the investigators will examine the implementation of the NEW Soul study with participants and intervention staff.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as African American
* Be between the ages of 18-65 years
* Body Mass Index between 25- 49.9 kg/m2
* Able to travel to restaurant for classes
* Be able to attend all monitoring and weekly class visits
* Be willing to be randomized to either group

Exclusion Criteria:

* Currently following a plant-based diet
* Diagnosed with diabetes that is controlled by medication
* Currently pregnant or breastfeeding (or plan to become pregnant in the next 24 months)
* Under the age of 18 years old
* Over the age of 65 years old
* Currently participating in a weight loss program
* Has lost more than 10 pounds in the past 6 months
* Potential eating disorder
Multidisciplinary Expert System for the Assessment & Management of Complex Brain Disorders

The Multidisciplinary Expert System for the Assessment \& Management of Complex Brain Disorders (MES-CoBraD) is an interdisciplinary project combining Real-World Data (RWD) from multiple clinical and consumer sources through comprehensive, cost-efficient, and fast protocols towards improving diagnostic accuracy and therapeutic outcomes in people with Complex Brain Disorders (CoBraD), as reflected in Neurocognitive (Dementia), Sleep, and Seizure (Epilepsy) disorders and their interdependence. It brings together internationally recognized experts in medicine, engineering, computer science, social health science, law, and marketing and communication from across Europe, and combines clinical information and scientific research in CoBraD with technical innovation in secure data-sharing platforms, artificial intelligence algorithms, and expert systems of precision and personalized care, with a primary focus on improving the quality of life of patients, their caregivers, and the society at large. It leverages RWD from diverse CoBraD populations across cultural, socioeconomic, educational, and health system backgrounds, with special attention on including vulnerable populations and minorities in an equitable manner and engaging key stakeholders to maximize project impact.


Eligibility Criteria:
Inclusion Criteria:

* All participants willing to undergo comprehensive assessment who visit one of three clinics (Epilepsy, Neurocognitive disorders, and Sleep Disorders), and healthy volunteers

Exclusion Criteria:

* participant disinterest
Performance Evaluation by Magnetic Resonance Imaging (MRI) of Intramuscular Thigh Injections With 3 Configurations of Needle-free Injector (ZENEO®)

The aim of this study is to evaluate the intramuscular nominal thigh injection performance and the low threshold strength thigh injection (by evaluating 2 low threshold : upper limit and lower limit). All participants will receive an intramuscular nominal thigh injection, and half of the participants will receive an intramuscular low threshold (upper limit) strength thigh injection, while the other half will receive an intramuscular low threshold (lower limit) strength thigh injection.


Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy volunteers aged between 18 and 60 years
* Affiliated to or covered by the French social security system
* BMI between ≥ 18 and \< 30 kg/m²
* Patients without chronic medical or surgical illness
* Patients with normal clinical examination at the screening visit
* Patients with normal blood pressure at the screening visit: systolic BP \< 140 mmHg and diastolic BP \< 90 mmHg, determined with the patient seated and resting for at least 5 minutes
* Patient within normal range values for the following laboratory tests (appendix I) unless the investigator considers an abnormality to be clinically irrelevant (to be documented and agreed with the sponsor before inclusion) within 1 month prior to the start of the study.
* Absence of cannabis, opiate, cocaine, amphetamine history
* Written Informed consent

Exclusion Criteria:

* History of drug abuse
* History of hypersensitivity (disease or drug)
* Treatment with platelet inhibiting drugs within one week before inclusion
* Treatment with anticoagulant within four weeks before inclusion
* Subject likely to take any medication during the study
* Contra-indication to MRI: metallic intra-corporeal devices, claustrophobia
* Prior participation to other interventional clinical research within 3 months
* In custody due to administrative or legal decision or under tutelage or being admitted in a sanitary or social institution
* pregnant or breastfeeding woman
Physical Activity Level of Patients With COPD During Pulmonary Rehabilitation

The aim of the project was to assess the acceptability of the device as well as adherence to the study. The objective of study was to assess physical activity in patients with COPD during in-hospital pulmonary rehabilitation program. The number of steps, average energy expenditure expressed in MET and kcal, and physical activity time during the consecutive 5 days of the rehabilitation stay were analyzed. Physical activity level was continuously monitored to assess intensity during in-hospital procedures as well as during leisure time.

The aim of the project was to assess the acceptability of the device as well as adherence to the study. The objective of study was to assess physical activity in patients with COPD during in-hospital pulmonary rehabilitation program. The number of steps, average energy expenditure expressed in MET and kcal, and physical activity time during the consecutive 5 days of the rehabilitation stay were analyzed. Physical activity level was continuously monitored to assess intensity during in-hospital procedures as well as during leisure time.

Patients participated in pulmonary rehabilitation program consisted of:

* specific respiratory exercises for 30 minutes - relaxation exercises for breathing muscles, strengthening exercises the diaphragm with resistance, exercises to increase costal or chest breathing, prolonged exhalation exercise, chest percussion, once a day for 30 min,
* training on a cycle ergometer, twice a day for 20-30 min.- until the Heart Rate reaches 70% of the HRmax (220-age),
* fitness exercises - coordination and balance exercises, stretching exercises using elastic bands, balls rehabilitation, sensory pillows. Performed in a standing position, kneeling, sitting, lying on side, abdomen and back, once a day for 30 min
* Schultz autogenic training, once a day 20 min.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed COPD;
* Agreement to participate in the study

Exclusion Criteria:

* Pneumonia, tuberculosis and other respiratory inflammatory disease in all stages and forms
* Condition after a heart attack
* Diabetes
* State after thoracic and cardiac surgery
* Heart failure (stage III, IV ° NYHA)
* Advanced hypertension
* Diseases and injuries that can impair the function of the musculoskeletal system of transportation
* Disturbances of consciousness, psychotic symptoms or other serious psychiatric disorders;
Postoperative Complications After Appendectomy

The frequency of complications after appendectomy is about 9% . The predictive value of CRP as an indicator of postoperative complications has been addressed in a small number of studies. The aim of the present retrospective analysis was to determine whether postoperative CRP levels are a reliable predictor of postoperative complications.

Background: Acute appendicitis is a common emergency in general surgery. The frequency of complications after appendectomy is about 9% \[9\]. The predictive value of CRP as an indicator of postoperative complications has been addressed in a small number of studies. The aim of the present retrospective analysis was to determine whether postoperative CRP levels are a reliable predictor of postoperative complications.

Methods: This retrospective single-center cohort study comprised 744 patients who had undergone open or laparoscopic appendectomy for clinically suspected appendicitis between 1 January 2011 and 31 December 2015 at the department of general and visceral surgery, Kepler University Hospital in Linz, Austria. Demographic data, the surgical technique, postoperative complications, histopathological findings, postoperative white blood counts, and C-reactive protein levels were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* clinically suspected appendicitis between 1 January 2011 and 31 December 2015

Exclusion Criteria:

* an elective appendectomy as part of an oncological or gynecological operation tumor was found intraoperatively and required ileocecal resection or right hemicolectomy
Evaluation of Clinical Performance and Usability of iStatis COVID-19 Ag Rapid Test at POC

A rapid point of care test for the detection of virus particles will be compared to the FDA approved EUA RT-PCR detection standard. The iStatis COVID-19 Ag Rapid Test is intended for rapid point-of-care detection of the SARS-CoV-2 nucleocapsid protein antigen.

Primary Objective: To evaluate the Clinical Performance of iStatis COVID-19 Antigen Test by untrained operators at Point of Care settings that meet requirements for CLIA waived tests.

Secondary Objective: To evaluate the performance of iStatis COVID-19 Antigen test around Limit of Detection Samples will be collected in CLIA Waived settings from approximately 200 subjects who present with or are referred for concerns about SARS-CoV-2. The goal is to collect a minimum of N=30 confirmed Covid-19 positive subjects and N=30 confirmed Covid-19 negative subjects of comparable ages, genders, and races.

Individual participation only includes sample collection and 1 day visit for the purpose of study

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing to sign verbal informed consent form
* Age 18 or older
* Subject is suspected case of COVID-19 by clinical criteria: a patient with acute respiratory tract infection (sudden onset of at least one of the following: cough, fever, shortness of breath, fatigue, decreased appetite, myalgia)
* Subjects with above mentioned symptom onset within the 7 days
* Participant is willing to provide two swabs - one anterior nasal swab sample for iStatis Test and another nasopharyngeal or nasal swab sample for comparator RT-PCR testing

Exclusion Criteria:

* Individuals who presented with 8 or greater days of COVID- 19 Related Symptoms, (Fever, Cough, Fatigue, Decreased Appetite, Shortness of Breath, Myalgia) or postdefervescence and/or convalescence
* Any reason as identified by the Principal Investigator at the participating site that could disqualify the subject from participation. The reason for exclusion was documented
* Subject withdraw consent