cyrilzakka/clinical-trials huggingface dataset:
Weight Management in Obese Pregnant Underserved African American Women

This project will test a novel lifestyle intervention to help overweight and obese socioeconomically disadvantaged African American women achieve healthy weight control during and after pregnancy and improve the health of their offspring. The treatment will be given through an existing national home visiting program, Parents As Teachers (PAT), which will facilitate sustainability and nationwide dissemination, if effective. We hypothesize that compared with standard PAT monitoring and counseling (PAT), women randomized to the lifestyle intervention program (PAT+) will have a lower percentage who exceed Institute of Medicine recommendations for gestational weight gain.

Maternal overweight/obesity and inappropriate gestational weight gain increase both maternal and neonatal morbidity and mortality. In addition, offspring of overweight/obese women are at increased risk for neurodevelopmental delay, becoming obese, and developing metabolic diseases. Women who are socioeconomically disadvantaged (SED), especially from African American populations, are particularly susceptible to adverse pregnancy-related outcomes because of their high prevalence rates of obesity. Therefore, successful weight management during pregnancy in SED, African American women has considerable public health implications. We have experience in testing lifestyle interventions among SED nonpregnant women that have been implemented and sustained within community organizations such as Parents As Teachers (PAT), a national home visiting program that provides parent-child education and services free-of-charge to high-needs women, prenatally and post-partum, with up to 25 home visits per year until kindergarten. We propose to conduct a 24-month (6-month prenatal and 18-month post-partum) randomized, controlled trial in overweight and obese SED African American women to evaluate the ability of an innovative lifestyle intervention program (PAT+), delivered by PAT parent educators during prenatal and post-partum home visits, to improve maternal and neonatal/infant weight, metabolic and health outcomes, relative to the standard PAT program (PAT). A programmatic evaluation will determine the applicability of the PAT+ intervention in real world settings by measuring programmatic reach, implementation, acceptability, and sustainability. If effective, PAT+ can be disseminated through this national organization, which currently reaches over 249,000 mothers and 319,000 children participating in 2,173 PAT programs across all 50 states.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant, African American, Socioeconomically disadvantaged
* Established prenatal care at our clinic before 15-6/7 weeks gestation
* Singleton viable pregnancy
* Gestational age 9 to 15 weeks
* Body Mass Index (BMI) of 25-45 kg/m²

Exclusion Criteria:

* Diagnosis of diabetes prior to pregnancy, or test results suggestive of pre-pregnancy diabetes
* Current use of certain medications
* Contraindications to aerobic exercise in pregnancy
* History of contraindicated medical conditions
Covid-19 Rapid Diagnostic Tests on Blood Drop

This study will evaluate the diagnostic reliability of the Biosynex rapid blood test for Covid-19 infection.

The Covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage them in an appropriate manner, in the appropriate departments. Furthermore, the diagnostic reference at the time of this study is based on reverse transcription by reaction in polymerase chain reaction (RT-PCR) on a nasopharyngeal swab taken. This method has may yield false negatives (up to 30% depending on the series) and its lead time is several hours.

Alternatives are therefore being developed, in particular rapid blood tests. The rapid diagnostic test distributed by Biosynex has been evaluated by the National Reference Center for Respiratory Infections Viruses as very specific for the detection of IgG + IgM (93%).

As part of the evaluation of this test, it was used in patients with severe Covid-19 disease, requiring hospitalization in critical care in order to be able to establish their reliability in a clinical context where many confounding factors may occur, such as lymphopenia or systemic inflammation. However, the early diagnosis of this patient population remains critical in order to be able to refer them to the appropriate services.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 diagnosis with at least one positive RT-PCR

Exclusion Criteria:

* None
Study to Evaluate Safety, Tolerability and Pharmacokinetics (PK) (Including Food Effect) of Oral Doses of AZD5847 in Healthy Volunteers

The main purpose of this study is to assess the safety and tolerability of AZD5847 after receiving oral doses on a single day (Part A) or after receiving a single oral dose in two periods (Part B). For volunteers in Part B, the effect of food on the PK of AZD5847 will also be studied. Another purpose is to evaluate the pharmacokinetics (PK) of AZD5847 and its metabolites in blood and urine.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
* Healthy male and female volunteers. Females must be of non childbearing potential

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
* History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
A Health Economic Trial in Adult Patients Undergoing Open Colectomy MA402S23B301

This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL therefore possibly reducing total hospitalization costs.

This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome extended-release injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age and older.
* Patients scheduled to undergo open segmental colectomy with planned primary anastamosis, as defined by cecectomy, right hemicolectomy, resection of transverse colon, left hemicolectomy, or sigmoidectomy.
* Ability to provide informed consent, adhere to study visit schedule, and complete all study assessments.

Exclusion Criteria:

* Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
* Patients who abuse alcohol or other drug substance.
* Patients with severe hepatic impairment.
* Patients currently pregnant or who may become pregnant during the course of the study.
* Patients with any psychiatric psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
* Patients who have participated in a EXPAREL study within the last 30 days.
* Patients who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.

In addition, the patient will be ineligible if he or she meets the following criteria during surgery:

* Patients with unplanned multiple segmental resections of large intestine.
* Patients who have unplanned, temporary or permanent colostomies, ileostomies, or the like placed.
* Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
* Patients who receive Entereg(R).
* Patients who undergo any concurrent surgical procedure during the ileostomy reversal surgery.
Team Approach to Polypharmacy Evaluation and Reduction in a Long-Term Care Setting

Medication side effects and interactions between medications are very common in older adults and are related to negative health outcomes. In this study, the investigators will test a new process aimed at reducing unnecessary medication use and drug side effects in seniors using the best medical evidence and patient preferences for treatment. This study will assess how feasible the implementation of this intervention is within a long-term care facility as well as if it is possible. Participants in two long-term care facilities will participate in this study. Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation. This trial will be a randomized control trial with an adaptive trial design.

There are substantial associations between polypharmacy and reduced function from older adults and this is likely to be important in frail older adults both in long term care and in the community. The reversibility of drug-induced mobility impairment is unclear therefore the investigators plan to investigate signals of any impact of reducing polypharmacy on mobility. The investigators chose the long-term care setting given the presence of complete medication administration records and this patient population's high prevalence of polypharmacy and risk of adverse drug events. TaperMD is an electronic tool for systematic medication reduction that incorporates patient priorities, electronic screening for potentially harmful medicines,supporting evidence tools and a monitoring pathway to support medication reduction. This study will examine the feasibility of this tool in a long-term care setting as well as examine. Participants in two long-term care facilities will participate in this study. Measures will include feasibility outcomes regarding the logistics of the intervention as well as patients outcomes (falls, hospitalizations, and medications) collected before and after implementation. The study will be an adaptive trial design with two phases. Phase 1 will be an internal pilot. This will allow the investigators to re-evaluate and modify outcome measures and processes as necessary. Phase 2 of this trial will allow for continuation after adjustments to the process or design has been made in a larger randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* residing in 2 long-term care facilities in Brampton, ON
* on 5 or more long-term medications
* 70 years of age or older
* adequate English language

Exclusion Criteria:

* terminal illness or other circumstance precluding 6 month study period
* recent (within 12 months) comprehensive medication review
CAR-T Immunotherapy Targeting CD19- ALL

This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Anti-CD19 chimeric antigen receptor T cell therapy has demonstrated unprecedented treatment responses in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many studies have reported that a subset of patients still relapse and about 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse after CD19 CAR-T-cell therapy usually have a poor prognosis. The mechanisms underlying CD19-negative relapses are not fully understood and it is important to develop solutions to supplement post-CD19 immunotherapies.

Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, CAR gene-modified T cells targeting CD22, CD123, CD38, CD10, CD20 or TSLPR have been considered in post CD19 CAR-T immunotherapy. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-negative B cell malignancies.

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 6 months.
2. Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy.
3. Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR.
4. The KPS score over 80 points, and survival time is more than 1 month.
5. Greater than Hgb 80 g/L.
6. No contraindications to blood cell collection.

Exclusion Criteria:

1. Complications with other active diseases, and difficult to assess patient response.
2. Bacteria, fungus, or virus infection, and unable to control.
3. Living with HIV.
4. Active HBV and HCV infection.
5. Pregnant and nursing mothers.
6. Under systemic steroid use within a week of the treatment.
Post Operative Dressing After Clean Elective Hand Surgery

Very little has been published about the optimal post operative dressing protocol, and no practical conclusion has emerged from a meta-analysis published in 2013. Even fewer studies focused on that topic specifically in hand surgery. Nevertheless, the functional impairment due to a dressing in the hand is much greater than anywhere else, due to the constant use of hands in daily life activities. Yet, habits differs widely following surgeon's preference, from daily change with application of an antimicrobial unguent, to unchanged dressing until the first follow up consultation after 2 weeks, to complete removal of the dressing and basic soap and water cleaning at postoperative day (POD) 1. Those varying recommendations have functional and logistical implication for the patients, especially the elderlies, for whom autonomy is a fragile status that can be dramatically impaired by such protocols. The goal of this study is to define which post operative dressing protocol is optimal in terms of wound complications (disunion, infection)


Eligibility Criteria:
Inclusion Criteria:

\* Elective hand surgery with clean wound (Type 1 in wound classification of american college of surgeon 11) - (Carpal tunnel, trigger finger, cyst removal or foreign body removal, tendon release).

Exclusion Criteria:

* Insertion of hardware
* Known skin condition disturbing normal healing,
* Immunodeficiency,
* Incapacity to understand or to observe the self cleaning protocol.
* Unexpected peroperative complication leading to a modification of the operative technique.
TOCOSOL(TM) Paclitaxel in Metastatic or Locally Advanced Unresectable Transitional Cell Carcinoma of the Urothelium

Phase 2B, multicenter study evaluating the safety and efficacy of weekly TOCOSOL Paclitaxel in taxane-naive patients receiving second line chemotherapy for metastatic or locally advanced, unresectable transitional cell carcinoma of the urothelium


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of transitional cell carcinoma (TCC) of the urothelium including bladder, renal pelvis, ureter, or urethra
* Stage IV disease
* One and only one prior systemic cytotoxic chemotherapy regimen administered as adjuvant or neoadjuvant chemotherapy or to treat locally advanced or metastatic disease
* Adequate hematologic function (ANC \>/= 1500 cells/mm3 \& platelet count \>/= 100,000/mm3)
* Serum creatinine \</= 2.0 mg/dL
* Total bilirubin \</= 1.5 mg/dL
* SGOT \& SGPT \</= 3 times upper limit of institutional normal values
* PT (INR) \& PTT within institutional lab normal range
* Karnofsky performance status of 60-100%
* At least one unidimensionally measurable lesion, suitable for radiographic evaluation of disease response, consistent with RECIST criteria
* Signed IRB/EC approved Informed Consent
* Life expectancy of at least 12 weeks
* 18 years of age or older
* Fully recovered from any previous surgery
* Not pregnant and willing to use a medically effective form of contraception during periods of chemotherapy treatment (both males and and females)
* Agree not to take vitamin E supplementation while receiving study medication
* Willing to participate in requested follow-up evaluations
* Willing to permit treating physicians to provide information to Sonus regarding disease status and survival for 2 years after first dose of study drug

Exclusion Criteria:

* Prior taxane-containing chemotherapy including Taxol(R) (paclitaxel) or generic equivalent, or Taxotere(R) (docetaxel)
* Peripheral neuropathy NCI-CTC grade 2 or greater
* Wide-field radiation, cytotoxic chemotherapy or hormonal therapy within 4 weeks of first dose, or mitomycin or nitrosoureas within 6 weeks of first dose, of study drug
* An investigational agent within 4 weeks of first dose of study drug
* Concurrent anticonvulsants known to induce P450 isoenzymes
* Patients who are pregnant or lactating
* A history of carcinoma of another primary site (other than non-melanoma skin cancers or carcinoma-in-situ of the cervix) within the previous 5 years, unless metastatic disease has been biopsied and documented to be TCC
* Bone metastasis, effusions, ascites or elevated tumor markers as the only evidence of metastatic TCC
* Brain metastasis
* Active bowel obstruction
* Active, serious infection or other serious medical problems (other than TCC) likely to impair completion of the study protocol
A Study of Retrograde rEperfusion in Dbd Donor LIver Transplantation

To evaluate whether retrograde caval reperfusion of liver graft could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction.

All eligible enrolled liver transplant candidates will be randomized to receive either:

1. retrograde caval, followed by sequential portal-arterial, reperfusion or
2. antegrade, sequential portal-arterial reperfusion.

We hypothesize that retrograde caval reperfusion could be superior over antegrade portal reperfusion in regard of incidence and severity of early allograft liver dysfunction.

Chi-square method of sample size estimation with a=0,05, b=0,20 and P1-P2 = 0,25 required a 41 subject per group (Stephen B Hulley, Steven R Cummings, Warren S Browner, Deborah G Grady, Thomas B Newman.-4th ed. Lippincott Williams \& Wilkins, 2013).

After signing the informed consent 90 patients will be randomized to study and active-control group (45 each).

Only patients undergoing classical technique (retrohepatic IVC resection) of liver transplantation without vena-venous bypass will be enrolled to the study.

In the study group after completion of both caval anastomoses (super and infra-hepatic) the infra-hepatic cava-clamp is released and removed allowing the filling and flushing the liver retrogradely through the hepatic veins. 300 ml of blood is drained via donor portal vein and the vein will be clamped.

Suprahepatic cava-clamp is released and removed allowing venous return to the right atrium.

Portal vein anastomosis will be constructed. Before the last 2-3 stitches another 100 ml will be drained retrogradely. Recipient portal vein clamp is removed and liver will be reperfused antegradely. After that arterial and biliary anastomoses will be constructed.

In the control group cava-clamps are not removed until completion the portal vein anastomosis.

Chi-square test and regression analysis will be used to test the difference in incidence of early allograft liver dysfunction in the study groups.

Mann-Whitney test will be used to compare the median of highest aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels 24 and 48 hours post-reperfusion.

Eligibility Criteria:
Donor Inclusion Criteria:

* deceased brain dead
* age 18-59
* length of ICU treatment up to 7 days
* highest AST and ALT up to 200 UI/L
* macroscopic steatosis up to 30%
* highest serum sodium up to 165 mmol/L
* highest bilirubin 25 µmol/L
* application of norepinephrine is allowed
* preservation solution - HTK (Custodiol)

Recipient inclusion Criteria:

* age 18-69
* primary liver transplant
* full-size transplant

Technique of liver transplant:

* with IVC resection;
* without veno-venous bypass;
* sequential portal-arterial reperfusion
* flushing of portal vascular bed with 500 ml of called to 2-4 °C saline at back-table before implantataion

Recipient exclusion Criteria:

* live donor liver transplant
* reduced and split grafts;
* multi organ failure (including fulminant and UNOS status 1);
* fulminant hepatic failure
Pelvic Floor Study: Biomechanical Properties of the Female Pelvic Floor

Pelvic floor dysfunction in the form of pelvic organ prolapse or urinary and fecal incontinence is a sequela for some women who experience injuries during birth. It affects adult women of all ages. The life time risk for women by age of 80 years for undergoing surgical correction is shown to be 11.1 % , and 29 % of them will undergo re-operation for recurrences later on. Still, even today the biomechanics of the pelvic floor is not understood enough. The aim of our study is to investigate the biomechanical properties of the female pelvic floor, i.e. the vaginal wall, by means of clinical, sonomorphometric (ultrasound), histological and elastomechanical examinations. In principle, the elasto-mechanical properties of the vaginal wall will be examined by the new and innovative so called aspiration device, developed at the Eidgenoessische Technische Hochschule (ETH) Zurich, Switzerland. This tool generates a low-pressure of -25 mbar at the vaginal wall, aspirating it under visual control by aid of an integrated video camera and therefore allowing to measure the difference of its convexity under aspiration and at rest. In case of prolapse surgery, this allows us to take a biopsy of the measured vaginal wall and analyze it at the Institute of Anatomy at the University of Zurich-Irchel by means of histological (e.g. connective tissue, extracellular matrix) and molecular biological examination. With an increasing elderly population, more and more women will need surgery for pelvic organ prolapse. While effective in restoring anatomy, sometimes by aid of meshes made out of polypropylene, the functional outcomes and quality of life are not always restored satisfactorily. This interdisciplinary project intends to add a contribution to this for our patient still bothersome situation and to help to detect risk factors for developing pelvic floor dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* pre- and postmenopausal women
* with pelvic organ prolapse, i.e. cysto- or rectocele, uterine descensus
* postmenopausal women

Exclusion Criteria:

* age under 18 years
* pregnancy / lactation
* current gynaecologic malignancies
* current malignancies of the pelvic floor
* infections such as HPV
* treatment with steroids or methotrexate
* no informed consent