cyrilzakka/clinical-trials huggingface dataset:
Study of Neurological Damage From Coronavirus Disease (COVID-19)

The objective of this study is to support the exploration of the NEURO-COVID-19 database and in particular to carry out the post-treatments necessary to derive quantitative information on the characterization of the lesion load, in particular with regard to of the vascular tree


Eligibility Criteria:
Inclusion criteria:

* Adult patient (≥18 years old)
* COVID + patient presenting with neurological symptoms leading to an MRI.
* Patient taken care of in one of the care centers associated with this research
* Patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Patient who expressed his opposition to participating in the study
* COVID patient not having neurological symptoms or not having received an MRI
* Patient under guardianship or guardianship
* Patient under legal protection
Antiepileptic Drugs in Elderly Patients

The purpose is to study the population pharmacokinetics, effectiveness and safety of antiepileptic drug (phenytoin, carbamazepine, lamotrigine, levetiracetam, parempanel, etc) in elderly patients and recommend optimized dosage regimens.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥65 years old;
2. Diagnosed with epilepsy;
3. Using antiepileptic drugs for treatment;

Exclusion Criteria:

1. Patients who are expected to die within 48 hours;
2. Patients with allergy to antiepileptic drugs;
3. Patients receiving other investigational drugs;
4. Other factors that the researcher considers unsuitable for inclusion.
Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?

With this prospective double-blinded, placebo controlled clinical trial we hypothesize that immediate (post-injury) intervention with Fluoxetine will prevent/mitigate the development of negative psychiatric symptomology such as PTSD and depression for victims of bodily trauma. We also hypothesize that immediate use of Fluoxetine will decrease subjects' pain, pain interference and opioid use without changing our standard of care post-injury pain medication regimen. Enrolled subjects will be randomized to Fluoxetine or placebo at their index hospitalization.

Upwards of 40-85% survivors of bodily trauma (in the civilian world most commonly motor vehicle accidents, falls and assaults), develop moderate to severe negative psychiatric symptomology following their injuries. (2,7) This symptomology can persist for years; at least 20% of patients with musculoskeletal trauma, specifically, display symptomology consistent with post-traumatic stress disorder (PTSD) symptomology up to three years following their injury. (8) Poor mental health outcomes are an independent risk factor for poor physical and social outcomes. (9,10) These symptoms, which are highly impairing, are complicated and heightened by loss of work/income following trauma, limited financial and social resources, and a large percentage of the population being uninsured/underinsured. Research has demonstrated that the pressures of poverty and low socioeconomic status alone predispose to PTSD symptomology and poor coping mechanisms, and this is compounded by decreased ability to obtain and pay for mental health care by those impoverished. There are significant barriers to mental health care for many adults, and these hurdles are even more insurmountable for those under or uninsured, minorities, and those in rural communities. (11) Very few victims of trauma who screen positive for psychological disorder receive mental health services following injury (12% at 3-months from injury), and if so, it is far removed from the injury (22% at 24-months from injury).

Eligibility Criteria:
Inclusion Criteria:

* Admitted to UF Health for trauma resulting in:

  * One or more extremity fractures requiring surgery
  * Pelvic Fracture
  * Chest/abdominal Injury requiring intervention in operating room
* Polytrauma (multiple organ systems/multiple fractures) or Beck Depression Inventory (BDI-II) ≥ 14

Exclusion Criteria:

* Severe Traumatic Brain Injury or cognitively not able to participate in surveys. (Glasgow Coma Scale 3-8)
* Other psychiatric conditions on current medical management (SSRI)
* Incarceration or Pregnancy
* Expected Injury Survival of less than 90 days
* Medical or physical condition in opinion of investigators that would preclude safe study participation
* Unable to provide informed consent due to language or other barriers
* Current or previous substance abuse (excluding cannabinoids and alcohol)
Safety and Effectiveness Study of Autologous Natural Killer and Natural Killer T Cells on Cancer

The purpose of this study is to assess the safety and effectiveness of natural killer (NK) cell and natural killer T (NKT) cell-based autologous adoptive immunotherapy in subjects with metastatic, treatment-refractory breast cancer, glioma, hepatocellular carcinoma, squamous cell lung cancer, pancreatic cancer, colon cancer or prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Male or female not less than 18 years of age or over 80 years of age.
* Life expectancy of ≥ 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status.
* Subjects must present with one of the following disease pathologies: Breast Cancer, Glioma, Hepatocellular Cancer, Squamous Cell Lung Cancer, Pancreatic Cancer, Colon Cancer or Prostate Cancer
* The pathology must be an assessable disease (measurable by CT scan or MRI) that is refractory to standard treatments (e.g., chemotherapy, radiation, etc.)
* Negative for hepatitis B, hepatitis C, HIV, and CMV.
* Subjects must present with leukocyte counts above 3,000/μL and platelet counts above 100,000/ μL.
* Subjects must present with minimum hemoglobin levels of 10.
* If female, subject is surgically sterile (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), post menopausal (no menses \>12 months), or using a high-efficiency method of contraception such as implant, injectable, combination oral contraceptive, intrauterine device (IUD) or sexual abstinence, or has a vasectomized partner.
* If female of childbearing potential, subject is not pregnant, breast-feeding or planning a pregnancy during the study, and has a negative pregnancy test on screening visit.
* Able to comprehend and sign an informed consent document and comply with the requirements of the study.

Exclusion Criteria:

* No measurable malignant disease by CT scan or tumor markers.
* Life expectancy of ≤ 24 weeks as measured by the Eastern Cooperative Oncology Group (ECOG) performance status.
* Age of less than 18 years or over 80 years of age.
* Documented/confirmed positive testing for hepatitis B, hepatitis C, HIV, or CMV.
* Prior or current history of autoimmune disease.
* Pregnant or lactating women.
* Leukocyte count \< 3,000 /μL prior to leukapheresis.
* Platelet count \< 100,000/μL prior to leukapheresis.
* Hemoglobin levels below 10.
* PTT (prothrombin time) of \< 12 seconds or \> than 15 seconds.
* aPTT (activated partial thromboplastin time) of \< 25 seconds or \> than 39 seconds.
* Failure or refusal to sign informed consent for the study.
* Culture fails to meet specifications for study.
* Subject has any other medical condition that, in the opinion of the investigator, might significantly affect the ability to safely participate in the study or affect the conduct of the study.
Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation

This study will compare and determine the most ideal local anesthetic (LA) solution to activate a labor epidural: lidocaine, bupivacaine, or a combination of bupivacaine plus lidocaine.

The most common and effective method for controlling labor pains is a local anesthetic (LA) infusion through a lumbar epidural. To achieve adequate pain control during the first stage of labor - onset of contractions to complete cervical dilation - nerve fibers up to the T10 dermatome must be anesthetized. When a patient is in active labor and an epidural catheter is placed, the anesthesiologist must activate the epidural by administering LA through the epidural to promote spread of the LA in the epidural space to anesthetize the nerve fibers involved in the conduction of labor pains. The ideal LA to achieve this goal is one that would allow for the fastest onset to achieve quick pain relief with the fewest side effects.

Two commonly used LA to provide labor analgesia are bupivacaine and lidocaine. When low concentrations - 0.25% bupivacaine and 1% lidocaine - are used for labor analgesia, both of these LA can be administered safely with very little concern of major adverse effects associated with LA toxicity. Given that there is limited and conflicting evidence for the usefulness of the bupivacaine and lidocaine mixture especially as it relates to labor epidural activation, we hope to readdress these questions in an effort to determine whether or not the LA combination offers any distinct advantage over the individual LA. The investigators intend to determine the time it takes to achieve an adequate level (T10) for labor analgesia, the total spread of local anesthetic, and the degree of motor block as these factors will be important in determining the most optimal LA solution to activate a labor epidural. With the results from this study, the investigators hope to recommend a LA solution that will allow for the fastest pain relief in the laboring mother with the fewest side effects.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients over the age of 19 who are scheduled for an induction of labor and request an epidural are eligible for the study

Exclusion Criteria:

* age \<19
* allergy to the drug or drug class
* preexisting neuropathy
* history of back pain prior to pregnancy or history of back surgery
* history of chronic opioid use
* history of hypertension or hypertensive disorders of pregnancy
* congenital or acquired cardiac disease
* contraindication to epidural placement (patient refusal, severe coagulopathy, infection at site of epidural needle insertion, severe hypovolemia)
Green Hysteroscopy

The purpose of this study is to determine whether green draping in the operating room prior to a hysteroscopy results in a decreased operating room time.

Secondary aims are to determine whether there are any differences in infection rate, complication rate, fluid deficit, operating room turnover time

Climate change will affect global health, with a disproportionate effect on women. To continue advocating for the patient population, it is necessary to decrease the carbon footprint of the medical field. The healthcare industry is responsible for many carbon emissions and waste generation. In a hospital, the operating room contributes 20-30% and uses 3-6 times more energy per square foot. There are growing attempts at "green" strategies to minimize the carbon footprint of surgery. Parts of this strategy include decreasing the amount of single-use supplies. From its production, transport, use, and disposal life cycle, single-use supplies contribute to a large amount to waste.

Hysteroscopies are a very common procedure with over 200,00 performed per year. hysteroscopy involves placing a camera into the uterus via the vagina and cervix. This can be performed for both diagnostic and therapeutic indications. Hysteroscopies have been classically performed in the operating room. In the operating room, there is an emphasis on maintaining the sterile field. The patient is prepped and draped, resulting in a large amount of excess drape usage. However, in-office hysteroscopies are gaining in popularity. In the office, draping is limited to the under buttock to capture the efflux. Institutions such as Newton Wellesley Hospital and Medstar Hospital systems all utilize minimal draping in the in-office setting.

There is no further sterile draping. There is not an increased risk of infections from in-office hysteroscopies. Overall, the rate of infections from hysteroscopy is very low ranging from 0.06- 0.18%. A study has shown that the usage of preoperative iodine in hysteroscopic in-office procedures does not decrease the postoperative infection rate. New studies focused on a minimal drape cystoscopy have also not shown any increase in infection rate.

The investigator and the team hypothesize that green draping for a hysteroscopy can decrease the operative time of a procedure without causing increased complications. This will also add to the procedure's decreased cost and carbon footprint.

Eligibility Criteria:
Inclusion Criteria:

* All women undergoing a hysteroscopic procedure at Emory St Joseph's, Emory Dunwoody ASC, Emory University Hospital, Emory University Hospital ASC.

Exclusion Criteria:

* Women undergoing a concomitant procedure along with the hysteroscopic procedure
* Pregnant women,
* Prisoners
* Cognitively impaired or Individuals with impaired decision-making capacity
Sorafenib Alone Versus Sorafenib Combined With HAIC for Advanced HCC

The purpose of this study is to evaluate the efficacy and safety of sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) compared with sorafenib Alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).

The results of our preliminary pilot study suggested that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for advanced stage HCC. Thus, the investigators carried out this prospective randomized control study to find out it.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* portal vein tumor thrumbus confirmed in two image techniques
* Eastern Cooperative Oncology Group performance status of 0 to 2
* with no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:

  * Platelet count ≥ 75,000/µL
  * Hemoglobin ≥ 8.5 g/dL
  * Total bilirubin ≤ 30mmol/L
  * Serum albumin ≥ 30 g/L
  * ASL and AST ≤ 5 x upper limit of normal
  * Serum creatinine ≤ 1.5 x upper limit of normal
  * INR ≤ 1.5 or PT/APTT within normal limits
  * Absolute neutrophil count (ANC) \>1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease
Effect of the Omentectomy on the Hyperglycemia and the Resistance to the Insulin in Patients With Morbid Obesity

To determine if the omentectomy diminishes hyperglycemia and improves the resistance to the insulin in patients with morbid obesity and propensity to develop to Diabetes Mellitus type 2.

To determine the Blood levels of glucose, curve of tolerance to the glucose, hemoglobin glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin in patients with Obesity Morbid and that will be put under umbilical surgery and cholecystectomy opened.

To put under them umbilical surgery or Cholecystectomy open with and without omentectomy To compare the Blood levels of of glucose, curve of tolerance wing glucose, hemoglobin glycosylated, insulin, triglyceride, cholesterol, HDL, LDL, leptin and Adiponectin before and after the procedure

Eligibility Criteria:
Inclusion Criteria:

* All the patients with Obesity Morbid who suffer of hernia umbilical Chronic Cholecystitis Lithiasic non worsened.
* Patient with age between the 18 to 55 years of age.
* Both sorts.
* Patient with index of corporal mass from 30 to 35.
* Patient with index waist greater or equal hip of 100cm in men and women greater of 88cm.
* Patient that has a central glucose of 100 to 125mg.
* Patient that has a tolerance to the glucose of 140 to 200mg.
* Patient which they have a result of triglyceride in blood of 300 or greater.
* Patient that has values of LHD below 40 mg/dl.

Exclusion Criteria:

* Patient that they have I diagnose already established of Diabetes Mellitus type 2 and in medical treatment.
* Patient with elevation of hepátic enzymes (more than 50% of the superior limits of normality) and/or creatinin in 1,5 serum \> mg/Dl.
* Patient with Diabetic ketoacidosis history.
* Uso of oral anticoagulants.
* Positive Test of pregnancy (Human Chorionic Gonadotropin ) for women.
* Recurrent Infections and at the time of the study.
* Umbilical Hernia complicated and strangled or Worsened Chronic Cholecystitis.
Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale

stroke's risk is increased in patients with pulmonary embolism and PFO compared to patients without PFO. Does this increased risk persist years after pulmonary embolism ?

324 patients included in EPIC-FOP study (2009 to 2015) were followed annually to collect data about the recurrence of VTE, cardiovascular events and treatments.

Eligibility Criteria:
Inclusion Criteria:

* patients included in EPIC-FOP study

Exclusion Criteria:

* refusal to participate
One vs. Two Hand Use After Stroke: Role of Task Requirements

To further develop interventions, the investigators need a better understanding of which task requirements (i.e. size or weight of object, location in workspace, etc.) drive a person after stroke to use 2 hands (as opposed to 1), and how the severity of their injury impacts this relationship and compare this to reaching in age-matched healthy controls subjects. A better understanding of this relationship will promote more informed development of rehabilitative interventions. This study proposes to explore in people after stroke and healthy controls: i.) how specific functional tasks requirements relate to 1 vs. 2 handed use, and ii.) how stroke severity impacts this arm use. We are proposing to study 15 individuals more than 6 months after stroke in the CSU Motor Behavior Lab for a two x 3 hour session of task-related reaching in sitting and 33 age matched (double sample size) healthy controls. The investigators will systematically vary task requirements (i.e. object size or weight, location in workspace, etc.), and record use of 1 versus 2 hands using videotaping as well as recording of quality of arm movement (kinematics) and muscle activity (EMG) in both arms.


Eligibility Criteria:
Inclusion Criteria:

subjects post-stroke

* passive flexibility (i.e. passive range of motion) in both arms such that the elbows can be straightened within 15 degrees of normal and shoulders be flexed (lifted up) at least 90 degrees and the hand needs to be able to open at least 75% of the way
* Actively (of each subject's own accord/ability) they must be able to, without assist in sitting and standing: straighten each elbow within 15 degrees of full range of motion, lift each arm up at at least 60 degrees from at the side, open each hand from a gross grasp volitionally.
* able to lift a glass jar using 1 or 2 hands in sitting and standing 10" above the table top.
* able to come to CSU for two x 3 hour visits with or without assistance of their caregiver/significant other
* No arm/hand injury within the last 3 months. \* Individuals with common visual deficits post-stroke (1 side partial visual field cut aka homonymous hemianopsia) will be included.

Healthy controls:

-age matched (double sample size); no known injury to arms within last 3 months, able to carry out experimental task, no neurologic diagnoses/perceptual or sensory deficits affecting arm movement

Exclusion Criteria:

* Individuals who have any additional/other neurologic condition (i.e. Parkinsons Disease, multiple sclerosis, spinal cord injury)
* severe perceptual neglect (tested using clock drawing test ).
* Any individual who cannot answer phone screen questions competently and/or follow simple 2 step commands during the in-person screen
Yoga to Reduce Cancer Fatigue

A randomized trial from the British National Health Service found that supervised exercise benefits women with early stage breast cancer with improved functional and psychological benefit after a 12-week intervention and 6 months later. Considering the needs of breast cancer patients and survivors and the reported benefits of exercise and yoga intervention, the investigators propose a pilot study of an 8-week yoga intervention in breast cancer patients. This study would specifically address measures of fatigue and psychosocial distress in the population of breast cancer patients during treatment and within the year following treatment. Currently there is very limited literature on yoga intervention in this population.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must have had histologically or cytologically confirmed breast cancer. This includes, but is not limited to: breast cancer-in situ; ductal carcinoma in situ; lobular carcinoma in situ; cystosarcoma phyllodes; inflammatory breast carcinoma; invasive breast carcinoma; and breast cancer not otherwise specified; cancer must be stage 0 through stage III.
* Treatment completion within the past calendar year.
* Age ≥ 18 years. While breast cancer can occur in the pediatric population, the pediatric population is best served by trials specifically designed for their age group.
* Life expectancy of greater than 1 year.
* Karnofsky ≥ 60%; see Appendix A.
* Women of childbearing potential are eligible for this study.
* Pregnant women are eligible for this study pending a doctor's note.
* The ability to understand and complete the study questionnaires.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
* Patients with known metastasis.
* Patients who are actively participating in a yoga class.
* Known uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would compromise subject health during yoga.
Systemic Inflammation Versus Acute Pain in Total Knee Arthroplasty (TKA)

In this study we evaluate if there is a correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA).

The correlation between acute pain and systemic inflammatory markers after total Knee Arthroplasty (TKA) is evaluated.

Level of systemic inflammatory markers (CRP and IL6) are measured preoperatively and 4 and 24 hours postoperatively. These measurements are correlated to postoperative pain (a detailed assessment of pain at rest and during ambulation).

We pole blood-samples collected prospectively (from two data set)

Eligibility Criteria:
Inclusion Criteria:

* Elective unilateral primary total knee arthroplasty
* Able to speak and understand danish
* Able to give informed consent

Exclusion Criteria:

* Alcohol or medical abuse
* Allergies to local anesthetics or methylprednisolone
* Age \< 18 years old
* Daily use of strong opioids or glucocorticoids
* Pregnancy or breastfeeding (fertile women)
* Bilateral / revision arthroplasty
* Dementia or other cognitive dysfunction
* Diabetic neuropathy, rheumatoid arthritis, and neurologic or psychiatric diseases potentially influencing pain perception