cyrilzakka/clinical-trials huggingface dataset:
B7-H3 Targeting CAR-T Cells Therapy for B7-H3 Positive Solid Tumors

This is a clinical study to evaluate the safety and efficacy of CAR-T cells in the treatment of patients with advanced solid tumors in China.

This is a single-center, single-arm, open-label study. This study is planned to enroll about 30 subjects with advanced solid tumors. Autologous CAR-T cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-70 and of both sexes;
2. Advanced solid tumor diagnosed by histology or pathology;
3. Relapse after receiving chemotherapy or targeted drugs or other second-line therapy;
4. B7H3 antigen was positive in tumor tissues by immunohistochemistry, and the antigen expression rate was more than 15%.
5. Patients had at least one evaluable tumor lesion according to RECIST 1.1 criteria that could be accurately measured at baseline;
6. The ECOG score is 0-2, and the expected survival time is more than 12 weeks;
7. Laboratory test results should at least meet the following requirements:

   Left ventricular ejection fraction ≥40%; Creatinine ≤200 umol/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelet (PLT) ≥80×109/L; Hemoglobin ≥80g/L; Oxygen saturation of blood 91%; Total bilirubin ≤2×ULN; ALT and AST 2.5 x ULN or less; The criteria for abnormal ALT and AST due to disease (e.g., liver metastases or bile duct obstruction) or Gilbert syndrome can be relaxed to ≤5×ULN.
8. Having venous access for blood collection or single blood collection;
9. The patient voluntarily participated and signed the informed consent in person.

Exclusion Criteria:

1. pregnant or lactating women;
2. Chemotherapy or radiotherapy was used within 3 days before the blood collection period;
3. Patients who have used systemic steroids within 5 days before blood collection period (except those who have recently or currently used inhaled steroids);
4. Use drugs to stimulate bone marrow hematopoietic cell formation within 5 days before the blood collection period;
5. Those who have used any gene or cell therapy products;
6. History of epilepsy or other central nervous system diseases;
7. Active hepatitis B or C virus, defined as: hepatitis B surface antigen HBsAg or hepatitis B core antibody HBcAb positive subjects with peripheral blood HBV DNA titer above the detection limit; HCV antibody positive for hepatitis C and HCV RNA positive in peripheral blood; People infected with HIV and syphilis;
8. Other tumors in the past 5 years;
9. Patients with severe chest and ascites;
10. There was active or uncontrollable infection requiring systemic treatment within 14 days before enrollment;
11. Other antineoplastic treatments (other than pretreatment and chemotherapy) were administered within 2 weeks before study initiation;
12. The investigator assessed that the patient was unable or unwilling to comply with the protocol.
Effect of Patient Position on Arterial, End-tidal and Transcutaneous Carbon Dioxide

Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery.

Investigators evaluate the effect of patient position (Trendelenburg and reverse Trendelenburg) on arterial, end-tidal and transcutaneous carbon dioxide partial pressure in patients undergoing laparoscopic surgery. Arterial carbon dioxide partial pressure is assessed intermittently before, during, and after pneumoperitoneum. End-tidal and transcutaneous carbon dioxide partial pressure are continuously monitored.

Eligibility Criteria:
Inclusion Criteria:

* adult patients undergoing laparoscopic surgery (expected duration of pneumoperitoneum \> 1 hour) in the Trendelenburg or reverse Trendelenburg positions

Exclusion Criteria:

* hemodynamically unstable patients due to decompensated heart failure, sepsis, or symptomatic arrhythmia, etc.
* symptomatic pulmonary disease, chronic obstructive pulmonary disease
The Use of the UroShield Device in Patients With Indwelling Urinary Catheters

According to the Israeli Ministry of Health requirement, this study was designed to evaluate the efficacy of the UroShield system is patients that require urinary catheterization. This was designed to compare standard treatment (urinary catheter alone) with the UroShield treatment in occurrence of catheter associated Urinary Tract infection, pain, discomfort, Biofilm prevention and trauma.

This study is aimed at assessing the effectiveness of the NanoVibronix™ UroShield™ System in comparison to Urinary catheter alone in patients requiring urinary catheterization.

1. Primary objectives

   * To observe the effect of UroShield in reduction of patient's complaints relating to indwelling Urinary Catheters

     * Pain
     * Discomfort
   * To observe the effect of UroShield in the reduction/prevention of Biofilm
   * To observe the effect of UroShield on the occurrence of bacteriuria and/or UTI's on patients with Indwelling Urinary Catheters
2. Safety Objective To assess the safety parameters of the UroShield system
3. Secondary Objectives

   * To observe the effect of UroShield in reduction of Foley Catheter related pain medication in patients with Indwelling Urinary Catheters
   * To observe the effect of UroShield in reduction of antibiotic medication in patients with Indwelling Urinary Catheter
   * To observe the effect of UroShield on the clogging of Urinary Catheter when used chronically and the need to replace the catheter
   * To observe the effect of UroShield on the decrease of Tissue damage of patients with Indwelling Urinary Catheters by measuring cell count before and after removal of catheter

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients age 18 years or older
* Patients requiring or having catheterization for more than 24 hours
* Patient able, agrees and signs the Informed Consent Form

Exclusion Criteria:

* Pregnant or breastfeeding women. Women of child bearing potential will perform a pregnancy test before inclusion into the study
* Presence of any clinically relevant known urinary tract infection
* Patient with condition who is not expected to survive the study period
* Known HIV positive
* Patient has any condition, which precludes compliance with study and/or device instructions.
* Patient is currently participating in another clinical study.
* Known allergy to latex
Trial of Antibiotic Prophylaxis in Elective Colorectal Surgery

To determine the optimal prophylactic antibiotics administration method in elective colorectal surgery

Use of prophylactic antibiotics in elective colorectal surgery is essential. Although single-dose prophylactic antibiotics are recommended, the efficacy of single-dose cephalosporin without metronidazole and oral antibiotics is not fully proven. We conducted a multicenter randomized trial of single-dose vs. three doses of the second-generation cephalosporin, cefmetazole.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal diseases (cancer, large polyp, carcinoid, lymphoma,sarcoma and so on)
* Elective colorectal resection

Exclusion Criteria:

* Emergent operation
* Ileus
* No resection
* Preoperative infectious diseases
* Penicillin or cephalosporin allergy
* Antibiotics administration before surgery
* Inflammatory bowel diseases
* Angina or myocardial infarction
* Renal dysfunction
* Diabetes mellitus
* Steroid administration before surgery
Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia

The present study was conducted in laparoscopic hysteromyoma patients, aiming to compare the effects of morning surgery with afternoon surgery on early postoperative sleep function and postoperative recovery under general anesthesia.

The circadian rhythm is an intrinsic timing mechanism generated by endogenous systems to adapt to the external environment, which is closely related to the human sleep-wake cycle. Patients after major surgery are prone to changes in sleep structure and sleep quality, called postoperative sleep disturbances (POSD), which are characterized by the total sleep time reduced, rapid eye movement sleep absent, slow wave sleep shortened, and shallow sleep phase increased, times of wakefulness increased, and highly fragmented sleep. Some studies have shown that POSD can aggravate postoperative pain and fatigue, increase postoperative delirium, cardiovascular adverse events, and even cause accidental death of patients. The investigators don't know whether the early postoperative sleep function and postoperative recovery quality of patients undergoing general anesthesia are affected by surgery in the morning or in the afternoon. The present study was conducted in laparoscopic hysteromyoma patients, aiming to compare the effects of morning surgery with afternoon surgery on early postoperative sleep function and postoperative recovery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-60 years old.
2. ASA status I or II.
3. BMI 18.5-28 kg/m\^2.
4. performed with laparoscopic myomectomy.

Exclusion Criteria:

1. combining with ovarian disease or ovarian surgery.
2. preoperative Athens Insomnia Scale (AIS) score ≥ 4 points
3. chronic use of sedative, hypnotic, psychotropic drugs.
4. recent night shift, cross-time zone, irregular life routine.
5. suffering from mental illness or hearing, visual impairment, and existing sleep apnea syndrome.
6. patients withdraw, or were unable to complete the trial after surgery.
7. lossed bleeding volume more than 500 ml during surgery.
8. performed procedure time exceeded 2 h.
Concomitant Treatment of Permanent Atrial Fibrillation

RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female subject between 18 to 80 years of age
2. Subject is scheduled to undergo elective cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including:

   * coronary artery bypass and/or
   * mitral valve surgery (repair or replacement)
   * aortic valve surgery (repair or replacement)
   * tricuspid valve surgery (repair or replacement)
3. Left Ventricular Ejection Fraction ≥ 30%
4. Subject is willing and able to provide written informed consent
5. Subject has a life expectancy of at least 2 years
6. Subject is willing and able to return for scheduled follow-up visits
7. TREATMENT SUBJECTS ONLY: Subject has a 3 month documented history of continuous atrial fibrillation
8. CONTROL SUBJECTS ONLY: Subject is not in atrial fibrillation at time of surgery

Exclusion Criteria:

1. Lone AF without indication(s) for concomitant CABG and/or mitral valve surgery, aortic valve surgery, tricuspid valve surgery or double valve surgery
2. Prior cardiac surgery (Redo -including previous ablation)
3. Patient requires atrial septal defect repair or any other concomitant open-heart procedure, other than CABG and/or mitral valve surgery; aortic valve surgery, tricuspid valve surgery or double valve surgery
4. Serum creatinine concentration greater than 2.0 mg/dl
5. Class IV NYHA heart failure symptoms and/or Class IV CCS anginal symptoms
6. Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurologic deficit
7. Active infection
8. Known carotid artery stenosis greater than 80%
9. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
10. A known drug and/or alcohol addiction
11. Mental impairment or other conditions which may not allow the the subject to understand the nature, significance and scope of the study
12. Pregnancy or desire to get pregnant within 12 months of study enrollment
13. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
Study of the Concordance of the Measurements Between the Evaluation of the Area of a Wound by the Technique of Transparent (Gold Standard) Compared to the Evaluation of the Area by the Algorithm of a Decision Support System (Wound-size)

The goal of this clinical trial is to compare the evaluation of a wound area and wound tissue content made by different methods on patient population with need for directed wound healing.

The main question test of the concordance of the measurements between the evaluation of the area of a wound by the technique of transparent (Gold standard) compared to the evaluation of the area by the algorithm of a decision support system (WoundSize)

Patient wounds will be examined:

* by eye by the principal investigator
* using a ruler by the principal investigator
* by WoundCare algorithms (AKA WoundTrack) using smartphone photography by the principal investigator
* tracing the outline of the wound using a transparent sheet by the principal investigator
* by eye by a second investigator
* using a ruler by a second investigator
* by WoundCare (AKA WoundTrack) algorithms using smartphone photography by a second investigator.
* tracing the outline of the wound using a transparent sheet by the second investigator


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from a wound requiring controlled healing ranging from 4 to 150 cm²
* Age greater than or equal to 18 years old
* Person affiliated to a social security scheme or beneficiary of such a scheme
* Person having received complete information on the organization of the research and having signed informed consent.
* Wound that can be taken in one photo in its entirety.

Exclusion Criteria:

* Person with a medical condition which, in the judgment of the investigator, is not compatible with participation in the study
* Wound on a part of the body that would make the person participating in the photos of the wound identifiable (tattoo, piercing, birthmark, etc.).
* Several wounds are in the photo.
* Pregnant, parturient or breastfeeding women
* Person deprived of liberty by a judicial or administrative decision
* Adult subject to a measure of legal protection (guardianship, curatorship, safeguard of justice) or unable to express their consent, persons subject to psychiatric care.
SPG Block for Acute Pediatric Migraine

This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache.

This is a randomized double blind trial comparing an intranasal sphenopalatine block with 2% lidocaine to intravenous (0.15 mg/kg, max 10mg) prochlorperazine in patients greater than 10 years of age presenting to a pediatric emergency department with an acute frontal migraine headache. Excluded populations include those with sickle cell, concern for CNS infection

Eligibility Criteria:
Inclusion Criteria:

- Frontal migraine headache

Exclusion Criteria:

* Non-english speaking
* Known pregnancy
* Sickle cell hemaglobinopathy
* Concern for CNS infection
* Acute febrile illness
* non-frontal headaches
* Concern for increased intracranial pressure
Gut Flora Metabolite Reduction After Dietary Intervention (GRADY)

Our group has recently identified the association between gut-flora-mediated carnitine and phosphatidylcholine metabolism, specifically trimethylamine-N-oxide (TMAO), and cardiovascular risk. This study investigates the ability for dietary intervention to modulate TMAO levels.

This is a pilot human study to characterize the relationship between gut flora-associated TMAO generation and dietary intervention. The investigators hypothesize that tailored dietary interventions may help to reduce the ability for gut flora to generate TMAO in individuals with elevated TMAO levels. Specific aims include:

1. To investigate the proportion of subjects with persistently elevated circulating TMAO levels.
2. To compare the amount of TMAO generated from gut flora using stable-isotope-labelled choline, carnitine, and betaine in subjects with elevated versus normal circulating TMAO levels.
3. To evaluate the effect of dietary interventions on the amount of TMAO generated from gut flora using stable-isotope-labelled choline, carnitine, and betaine in subjects with elevated circulating TMAO levels.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1 Inclusion criteria:

* Men and women age 18 years or above.
* Elevated TMAO metabolizers (\>5 µM) based on screening test and/or eGFR \< 60 at most recent measurement.
* Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
* Willing to sign the consent form and follow the study protocol, which includes a 12-week dietary modification.

Cohort 2 Inclusion criteria:

* Men and women age 18 years or above.
* Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
* Willing to sign the consent form and follow the study protocol.
* eGFR values ranging from 16-59

Cohort 3 Inclusion criteria:

* Men and women age 18 years or above.
* Willing to remain on aspirin or able to be off aspirin or aspirin products for 1 week prior to starting the study and staying on the same aspirin regimen during the duration of the study.
* Willing to sign the consent form and follow the study protocol.

Exclusion Criteria (all cohorts):

* Significant chronic illness or end-organ dysfunction, including known history of uncompensated heart failure, renal failure, pulmonary disease, hematologic diseases.
* Active infection or received antibiotics within 2 months of study enrollment
* Use of over-the-counter probiotic within past month, or ingestion of yogurt within past 7 days
* Having undergone bariatric procedures or surgeries such as gastric banding or bypass.
* Pregnancy.
* Any condition which, in the judgment of the Investigator, would place a patient at undue risk by being enrolled in the trial, or cause inability to comply with the trial
Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening

The purpose of this study is to implement an electronic consent education process for the retention and research use of residual dried bloodspots at four hospitals in Michigan and assess the impact of the new education, both on patients and hospital staff. The research team will recruit women who have just given birth to answer surveys about the Michigan BioTrust consent process. Surveys will be collected from participants in the hospital and again four weeks later. The research team will collect survey data from patient participants at each hospital prior to hospital staff implementation of the new education process and again after staff implementation.

The research team will compare a prospective observational control group enrolled during pre-implementation data collection within a hospital (n=2,990) to the implemented consent process group enrolled at the same hospital after implementation (2,990). Implementation will consist of hospital staff providing patients with access to a website with detailed written descriptions and a video about the Michigan BioTrust. The current standard of care, that will be maintained in addition to the new website, involves providing the patient with a brochure and descriptive information from hospital staff about the Michigan BioTrust.

A research staff member will approach patients and ask if they are willing to answer some surveys about the BioTrust consent process. After agreeing to answer the surveys, the researcher will provide them with a direct link to the research survey. If the participant does not have a phone or tablet with them, the research team member will provide a tablet upon which they can answer the questions on the survey.

All participating women or men will complete a survey 1) in the day following the BioTrust Consent and 2) at roughly 4 weeks later by email, text or telephone.

Hospital employees involved in the implementation will also answer surveys about potential sustainability immediately after completing training and again after several months of implementation.

Eligibility Criteria:
Inclusion Criteria:

* Adult (\> 18 years)
* English, Spanish or Arabic speaking
* Just gave birth and currently a patient in the Mother \& Baby Unit in the hospital

Exclusion Criteria:

* Parents of infants who are born pre-term (\< 37 weeks gestation)
* Parents of infants in the Neonatal Intensive Care Unit
* Parents of infants being put up for adoption or in situations where legal guardianship is unknown at the time of birth
CSF Cholinergic Biomarkers and Postoperative Cognitive Change

Previous study demonstrated that the condition of central cholinergic nerve is important for the postoperative cognitive dysfunction. In present study investigators hypothesized that the acetylcholine concentration in the cerebral spinal fluid is associated to the postoperative cognitive changes in aged patients undergoing osteopathic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elder than 60 years old
* Spoke proficient Mandarin Chinese
* Agree to undergoing spinal plus general anesthesia
* Selected total knee replacement surgery

Exclusion Criteria:

* Patients with neurological and/or psychiatric diseases, including AD, stroke and psychosis
* Have contraindication for spinal anesthesia such as clotting disorder local infection in the puncture site
* Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
* Several audition or vision disorder
* Unwillingness to comply with the protocol or procedures.
Applying the Use of Motivational Tools to Auditory Rehabilitation

The purpose of this study is to compare two different ways of helping first-time hearing-aid users get the most out of their hearing aids and determine if one method is better than the other. One method provides the patient with routine information regarding the care and use of hearing aids the other method uses tools to address patient-specific barriers against and motivators for hearing-aid use.


Eligibility Criteria:
Inclusion Criteria:

* be aged between 20 and 89 years
* be a first-time hearing-aid user
* air-conduction pure-tone averages (mean thresholds at 500 Hz, 1000 Hz, and 2000 Hz) of 70 dB HL or less in both ears
* word-recognition scores of 40% or better in each ear
* English as their first language
* have sufficient vision and reading ability
* have the appropriate cognitive skills to participate in the study as determined by the Mini Mental State Exam, 2nd Edition - Brief Version (Folstein et al., 2010)
* have been fit by the VA Portland Health Care System Audiology and Speech Pathology Service (ASPS) with two hearing aids which have datalogging capabilities
* be independent in their completion of activities in daily living, as determined by their score on the Katz Index of Independence in Activities of Daily Living (Katz et al., 1970)
* have poor adoption of their hearing aids
* be free of a documented diagnosis in the VA Computerized Patient Record System (CPRS) record of neurological or psychological disorder, such as Alzheimer's disease, schizophrenia, or uncontrolled substance abuse, which would interfere with the completion of the study. Vulnerable populations are not being studied.

Exclusion Criteria:

Failure to satisfy any of the requirements listed as inclusion criteria