cyrilzakka/clinical-trials huggingface dataset:
PEEP Titration and Lung Recruitment Potential Assessed by 3D EIT

In a population of ARDS patients, we explore the influence of different PEEP levels on regional ventilation distribution, ventilation homogeneity, and the center of ventilation, optimal PEEP and lung recruitment potential as well as the extent of lung collapse and overdistension as detected by 3D-EIT.


Eligibility Criteria:
Inclusion Criteria:

* patients on mechanical ventilation.
* Diagnosis of ARDS was based on the Berlin definition
* lung recruitment potential assessment and PEEP titration was proper for the ARDS patients determined by the attending doctor

Exclusion Criteria:

* Under 18 years of age.
* Pregnant women;
* Ribcage malformation
* Any contraindication to the use of EIT (e.g. automatic implantable cardioverter defibrillator, and implantable pumps).
* Hemodynamic instability, unable to tolerate high PEEP;
* High-risk individuals with pneumothorax, mediastinal emphysema, etc.
Methylprednisolone Adjunctive to Endovascular Treatment for Stroke

The efficacy and safety of methylprednisolone in acute ischemic stroke patients with large infarct cores (ASPECTS score \< 6) due to anterior circulation large vessel occlusion have not been clearly established. This is a multi-center, randomized, double-blind, placebo-controlled trial to investigate early combination therapy with methylprednisolone for reperfusion in acute large core infarction.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* The time from onset to randomization was within 12 hours.
* Anterior circulation ischemic stroke was determined according to clinical symptoms and imaging examination.
* Occlusion of the intracranial internal carotid artery, the M1- or M2-segment of the middle cerebral artery confirmed by CT angiography (CTA), MR angiography (MRA), or digital subtraction angiography (DSA).
* Baseline National Institutes of Health Stroke Scale (NIHSS)≥6.
* Baseline Alberta Stroke Program Early CT Score (ASPECTS)\<6.
* Planned treatment with endovascular therapy (EVT).
* Informed consent obtained from patients or their legal representatives.

Exclusion Criteria:

* Intracranial hemorrhage confirmed by cranial computed tomography (CT) or magnetic resonance imaging (MRI).
* mRS score ≥ 2 before onset.
* Pregnant or lactating women.
* Allergic to contrast agents or glucocorticoids.
* Participating in other clinical trials.
* Systolic blood pressure \>185 mmHg or diastolic pressure \>110 mmHg, and oral antihypertensive drugs cannot control.
* Genetic or acquired bleeding constitution, lack of anticoagulant factors, or oral anticoagulants and INR \> 1.7.
* Blood sugar \< 2.8 mmol/L (50 mg/dl) or \> 22.2 mmol/L (400 mg/dl), platelet \< 90 x 10\^9/L.
* The artery is tortuous so that the thrombectomy device cannot reach the target vessel.
* Bleeding history (gastrointestinal and urinary tract bleeding) in recent 1 month.
* Chronic hemodialysis and severe renal insufficiency (glomerular filtration rate \< 30 ml/min or serum creatinine \> 220 umol/L \[2.5 mg/ dL\]).
* Life expectancy due to any advanced disease \< 6 months.
* Follow-up is not expected to be completed.
* Intracranial aneurysm and arteriovenous malformation.
* Brain tumors with imaging mass effect.
* Systemic infectious disease.
Combined Electroencephalogram, Magnetic Resonance Imaging-Positron Emission Tomography of Dexmedetomidine Induced Sleep

The investigators are doing this research study to find out how and where dexmedetomidine, a sedative anesthetic, acts in the brain. The investigators will do this by using a machine that records the brains electrical activity, called an electroencephalogram (EEG), and brain imaging scans to look at the brain.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I
* 18 to 35 years of age

Exclusion Criteria:

* MRI and/or PET screening criteria not met
* Abnormal sleep habits/known or suspected sleep disorder(s)
* Taking medication that alters sleep, cognitive function, or both -History of a known neurological or psychiatric problem -Younger than 18 or older than 35 years of age
Betaseron Pregnancy Registry

This is a prospective, observational, registration and follow-up study of women exposed to Betaseron® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The Betaseron® Pregnancy Registry is designed to determine whether there is an increased risk or a pattern of birth defects in the offspring of women exposed to Betaseron® at conception and during pregnancy compared to rates from women in the general US population. Secondarily, the Registry will examine rates of spontaneous abortions and other negative pregnancy outcomes in this population. This study will be conducted in the United States (US). The Betaseron® Pregnancy Registry is sponsored by Bayer HealthCare Pharmaceuticals and is managed by the Post Approval \& Strategic Services group at INC Research, LLC. The scientific conduct and analysis of the Registry will be overseen by an Independent Data Safety Monitoring Board (IDSMB) consisting of external specialists in teratology, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).

Because informed consent is required, the Registration process must be initiated by the patient. An HCP who contacts the Registry may request an authorization for release of medical information packet or have the eligible patient contact the Registry directly. Once an eligible subject provides consent and permission to obtain information from her HCP, the Registry will contact the obstetric HCP and obtain information on demographics, history of previous pregnancies, maternal risk factors, pregnancy outcome, and neonatal health. Data will be collected from the maternal HCP at enrollment, during the second trimester (around week 20), and at outcome. Data on live born infants will be collected from the pediatrician at 4 months of age. If a birth defect is reported, targeted follow-up may be conducted.

NOTE: This study has previously been posted by Berlex, Inc. which has since been renamed to Bayer HealthCare Pharmaceuticals, Inc. Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of this pregnancy registry.

Eligibility Criteria:
Inclusion Criteria:

The subjects must meet the following criteria for registration:

* Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)
* Diagnosed with MS prior to or during the current pregnancy
* Exposed to Betaseron® on or after the first day of the patient's last menstrual period
* Provide verbal consent to participate in the Registry
* Verbally provide contact information for herself, her HCP, and the infant's HCP (as applicable)
PH-797804 Versus Placebo For The Treatment Of Neuropathic Pain Associated With Post-Herpetic Neuralgia

This is a proof-of-concept study to determine if PH-797804 reduces neuropathic pain associated with post-herpetic neuralgia. Suitable patients will be randomized to receive either PH-797804 or placebo for 4 weeks, during which time they will also record their pain symptoms using various pain scales.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age
* Patients must have pain present for more than 3 months after healing of the Herpes zoster skin rash. There is no upper limit on the duration of PHN.
* Patients at screening visit (V1) must have a score ≥40 mm on the Pain Visual Analog Score (VAS).

Exclusion Criteria:

* Patients having other severe pain, which may impair the self-assessment of the pain due to post-herpetic neuralgia
* History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, New York Heart Association (NYHA) Class III-IV congestive heart failure requiring treatment, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transient ischemic attacks).
* Tuberculosis without treatment and/or positive tuberculin reaction to PPD (Purified Protein Derivative) without known (documented) vaccination with the bacilli Calmette-Guerin vaccine (BCG).
* A positive approved immunoassay/ELISA blood test for TB (e.g. TB T-SPOT™, QuantiFERON-Gold
* Any clinically significant skin lesions as described in Common Terminology Criteria for Adverse Events for Dermatology (CTCAE) Version 3.0
* ECG abnormalities at screening or randomization
* Evidence of organ dysfunction or hematopoietic disorder
Evaluation of Diprospan Injection to the Knee on Rehabilitation of Patients After TKR of the Contralateral Knee

This study is performed to assess the influence of intraarticular injection of 2ml Diprospan (wich contains 4mg Betamethasone sodium phosphate and 10mg Betamethasone dipropionate) into osteoarthritic knee in patients who undergo a total knee replacement of their contralateral knee.

The study population will include 50 patients with bilateral knee osteoarthritis, admitted for their first knee replacement surgery. Only patients with older than 50 years with primary osteoarthritis will be included. The patients will be randomized into 2 groups. Intervention group will receive an injection of 2ml Diprospan diluted in 10 ml Bupivocaine. The control group will receive an injection of 10ml of Bupivocaine. All patients will be followed after 6 weeks and three functional rehabilitation and pain scores will be assessed (VAS pain score, Timed Up and Go Score and Functional Ambulatory Category Scale).


Eligibility Criteria:
Inclusion Criteria:

* Age older than 50
* Bilateral primary knee osteoarthritis
* Undergoing knee arthroplasty

Exclusion Criteria:

* Active infection
* Allergy to medication compounds
* Pregnancy
Fluid Administered According to PVI Versus Fluid Management in Laparoscopic Trendelenburg Surgeries

Investigating the ideal fluid management in Trendelenburg positions during lower abdominal laparoscopic surgeries in gynecological oncology and surgical oncology patients

Laparoscopic lower abdominal surgeries include carbon dioxide (CO2) insufflation and an advanced Trendelenburg position with the head down. Increased intra-abdominal pressure can reduce cardiac index and cause changes in total body fluid balance. However, the head down Trendelenburg position increases intracranial pressure and preload. According to traditional fluid management, intraoperative fluid deficit is calculated according to the 4-2-1 rule, by summing up hourly basal fasting level, intraoperative losses due to degree of tissue trauma (1-2mlt/kg/h in minor surgeries, 2-4mlt/kg/h in medium surgeries, 4-8mlt/kg/h in major surgeries), blood losses, urine and losses from nasogastric tube.

Preservation of intravascular volume and thus provision of hemodynamic stability are among the factors affecting postoperative morbidity and mortality. Some studies have shown that standard fluid therapy is more than necessary. Current guidelines recommend more restrictive approaches by ensuring hemodynamic stability. Masimo, which we also use routinely in our clinic, is a device designed for continuous noninvasive monitoring of arterial hemoglobin functional oxygen saturation (SpO2), pulse rate (PR), pleth variability index (PVi) and pleth respiratory rate (Rrp) PI (perfusion index) values. In our study, in the individualization of the recommended target-oriented restrictive fluid therapy in major surgeries, by comparing the calculated fluid amount with traditional fluid management with PVI values (PVI is evaluated between 0-100.

Normavolemia 15-25 low fluid responsiveness \<15 high fluid responsiveness \>25) and when the patient's massimo pvi score is \>25, 300cc bolus fluid will be administered and fluid will be loaded at an average speed and the PVI value will be reduced below 25. When the patient's massimo PVI value is below 25, restrictive fluid therapy will be followed.(A crystalloid fluid infusion of 2 mL/kg was administered to the patients.)

The aim was to investigate the ideal fluid management in Trendelenburg positions in lower abdominal laparoscopic surgeries performed in gynecological oncology and surgical oncology patients.

Eligibility Criteria:
İnclusion Criteria:

* between the ages of 18-80
* patients with ASA score II III
* Laparoscopic lower abdominal surgery (patients undergoing gynecological oncology and surgical oncology surgery)

Exclusion Criteria:

* ASA score IV
* Patients with heart failure and chronic kidney disease
* Patients who did not agree to participate in the study
* Cases that started laparoscopically and converted to laparotomy
Facilitating Participation in a Prostate Cancer Risk Assessment Program

The purpose of this study was to examine whether a cognitive-affective preparation was more beneficial, in general, and more specifically for certain subgroups, such as African-American men and individuals with high monitoring style.

High risk men enrolling in a state of the science Prostate Cancer Risk Assessment Program (N = 128) underwent a Pca counseling visit immediately followed by either a cognitive-affective preparation (CAP) session designed to help men process the information they received or a general health education session to control for time and attention (comparison group). All men chose to participate in Pca screening.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian men, 34 and 69 years of age, at least one first or second degree relative with prostate cancer

OR

* African American men, 35 and 69 years of age

Exclusion Criteria:

* cancer diagnosis
* difficulty communicating in English
* impaired competency to give informed consent.
A Pilot Study for Efficacy of Cognitive and Physical Training in Patients With Mild Cognitive Impairment

This is to find out the effectiveness of cognitive and physical function training for patients with mild cognitive impairment.

It is for the prevention and treatment of dementia in the future. randomized, Pilot Study.


Eligibility Criteria:
Inclusion Criteria:

1. men and women aged 60 or older
2. A person who falls within the abnormal range of the Montreal Cognitive Assessment (MoCA) test
3. a person who can independently carry out daily life
4. If the subject or legal representative voluntarily decides to participate and agrees in writing to comply with the precautions after hearing and fully understanding the detailed explanation of this clinical study

Exclusion Criteria:

1. A person diagnosed with Alzheimer's dementia or other causes (stroke, brain tumor, cerebral palsy, dementia, Parkinson's disease, etc.)
2. A person with unstable cardiovascular system, digestive system, respiratory system, endocrine system, etc. and poor general condition
3. Patients who have participated in other treatment clinical studies or who have participated in other treatment clinical studies within the last 30 days
4. Other cases where the researcher determines that participation in this clinical study is not appropriate
Genomic Investigation of Unusual Responders

Studies have shown that tumors from the same patient may respond very differently to the same therapeutic agents. This study aims to investigate the genetic basis of tumors that respond abnormally well or poorly to therapeutic agents in an effort to understand the fundamental genetic basis of this response. The present protocol seeks to retrospectively perform Exome, next-generation (DNA) sequencing and/or other molecular techniques on tumor samples to identify the genetic basis of a patient's exceptional response to chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician.

   1. The exact definition of this is adaptable to the disease but a suggested guideline is a Complete Response, Partial Response or progression free interval of at least 6 months
   2. Exceptionally poor response includes patients who were expected to respond favourably to a treatment but instead responded poorly (e.g dramatic tumor growth or death)
2. The patient must have sufficient archival tumor available for sequencing.
3. Deceased patients will also be considered for analysis (up to 30 patients per year) if they meet at least one of the following requirements:

   a)) Patients who have archival tissue stored within the UHN Laboratory Medicine Program who have had a consent waiver granted by the REB to access the tissue.

   b) Patients who have archival tissue banked for further research within the UHN Biospecimen Sciences Program

   Exclusion Criteria:
   * None
Comparison of Outcomes Between Warshaw and Kimura Techniques for Spleen-preserving Minimally Invasive Distal Pancreatectomy

Spleen-persevering distal pancreatectomy (SP-DP) has been widely advocated as a routine procedure for benign or low-grade malignant tumors in the pancreatic body and tail, especially with a minimally invasive approach. Spleen preservation can be accomplished with Kimura technique (KT) or Warshaw technique (WT) Both of the two techniques were proved to be feasible and efficient. However, the perioperative outcomes and long-term benefits between patients with KT and WT in spleen-persevering minimally invasive distal pancreatectomy (SP-MIDP) remains controversial.

Several small series have reported a slightly higher prevalence of postpancreatectomy hemorrhage (PPH) in patients who undergo KT than those undergo WT. The exposure of splenic vessels to erosive pancreatic juice and the preservation of splenic vessels itself may explain the higher chance of PPH in KT. Larger volume studies are warranted to confirm this finding and to clarify the clinical significance. This study compared the perioperative outcomes between the two spleen-preserving techniques, with a focus on parameters relating to perioperative patient safety. Especially, the incidence and clinical relevance of PPH in SP-MIDP were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* pathological diagnosis of benign or low-grade malignant pancreas tumors.

Exclusion Criteria:

* incomplete medical records,
* history of previous splenectomy,
* high-grade malignant pancreas tumors,
* conversion to open DP (ODP).
Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes

The use of machine learning techniques using an artificial intelligence tool is proposed to analyze clinical data to predict best possible IVF/ART outcomes. This tool has been utilized to accurately predict embryo quality here at Cornell. Utilizing this tool to assess objective clinical findings and predict outcomes of assisted reproductive techniques is sought, with the ultimate goal of an automated tool to reduce implicit physician bias. Within this goal, using this tool to objectively and accurately assess baseline ovarian reserve at the start of an ART cycle is proposed, using 3D sonography to image the ovary and artificial intelligence tool to objectively identify baseline antral follicle counts.

This study will collect prospective data, specifically 3D transvaginal ultrasound of ovaries at time of baseline evaluation at beginning of an ART cycle. All participants will be asked to give written consent to be included in the study. At the time of initial ultrasound that is routinely done on the first day of the ART cycle, the physician performing the ultrasound will use a 3D ultrasound transvaginal probe to perform the ultrasound and capture both 2D and 3D images. 3D ultrasound is performed routinely for patients undergoing ART and is not an investigative procedure, however is not uniformly performed at the time of the baseline ultrasound. As per standard practice, the baseline antral follicle count will be documented by the performing physician, as well as a 3D image saved to be analyzed later using AI.

Information about the medical history, treatment and outcomes will be collected as part of the study. Data maintained in the medical record as a result of standard of care monitoring for IVF and IUI will also be used for this study. This will include semen analysis (male partners if applicable) and pregnancy outcomes. For male partners, the semen analysis record will be part of the fertility history and semen analysis will be performed as standard of care with semen processing for fertilization. Additional data related to the treatment and outcomes will be collected from the medical record from the time of consent through the end of the treatment (including pregnancy outcomes).

The time commitment for subjects may take up to 1 month (time from consent signing to 3D ultrasound) and to the time of delivery if pregnant (up to 9 months). No further procedures will be performed in the study group.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing ovarian stimulation (including OI and IVF cycles)
* Treatment for fresh embryo transfer and cryopreservation of oocytes or embryos upfront
* Healthy male partners of the female subjects who agree to be part of the study.

Exclusion Criteria:

* None
Pilot Randomized Controlled Study of the Impact of MedRhythms' MR-010 in Acute Stroke

The purpose of this clinical pilot study is to evaluate the effects of the MR-010 on tolerability, biomechanics and walking speed in the acute stroke care setting in addition to its impact on length of stay.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older.
* Must be able to read and speak English fluently.
* Be within 24 hours from admission for confirmed stroke event.
* Currently able to walk at a speed greater or equal to 0.4m/s, but less than 1.0m/s, as determined by a 10-meter walk test for comfortable walking speed (the average of three trials).
* Demonstrates some level of asymmetry in gait.
* Is expected to be discharged from the acute care setting requiring physical therapy per standard of care and participant has verbally committed to receiving at least one therapy session.
* Able and willing to consent with proposed study schema (verbal commitment), including consent to participate in communication with the treating clinician (as needed) during the study period.
* Score ≤1 on question 1b and a 0 on question 1c on the NIH Stroke Scale.
* Able to safely participate in protocol-defined walking therapy sessions of 30-minute duration as determined by the Investigator.

Exclusion Criteria:

* Participant unable or unwilling to provide informed consent.
* Has a known history of neurologic (excluding stroke) injury.
* Has severe aphasia and/or a speech/language disorder, limiting ability to express needs and comprehend instructions.
* Has an external lower limb prosthetic ("artificial limb").
* Has a hearing impairment.
* Had orthopedic surgery in the last year.
* Has co-morbidities that prevent participation in exercise (for example: musculoskeletal, cardiovascular, pulmonary and neurological - other than stroke).
* Vulnerable populations as deemed inappropriate for study by site Principal Investigator.