cyrilzakka/clinical-trials huggingface dataset:
Giving Information on the Risks and Limitations of Mammography Screening (GIRLS)

To trial the provision of full information on the benefits and risks of mammography in women that are eligible for breast screening. The knowledge many women have of mammography is not reflective of the recent change in evidence; it is often missing information on over-diagnosis and over-detection. Women tend to overestimate their risk of breast cancer and the benefits of breast screening. In addition, universal breast screening programs are biased towards emphasizing screening. However, a mammogram is not a perfect test and there is no right or wrong decision about whether to have a screening mammogram. It is an individual woman's decision to make. To understand the effect of changing information to reflect the potential for over-diagnosis and over-treatment, we will carry out a pragmatic controlled trial of implementation of balanced information on mammography in family practice.

1:1 double-blinded randomized controlled trial of patients to receive the intervention or standard information (control) at the study start in an information package. The intervention includes a decision aid (previously developed by Hersch et al. 2015, with minor modifications to reflect the Canadian context), a YouTube video link and an invitation to attend a group information session. The intervention or standard information, depending on participants assigned study group, will be mailed or emailed to participants. The information packages will also include questionnaires to collect data on outcome measures. There will be two study waves to account for women's eligibility at different time points (i.e. when approaching a mammogram due date). The first wave of participants will receive their information package at the study start and the second wave of participants will be sent their information packages 6 months after the study start. Each wave of participants will be followed for one year. Data collection will include quantitative measures of factors relevant to the decision-making process. Screening participant rates will be measured for each wave of participants, 6 months and 12 months after their respective enrollment date. Qualitative methods will be used to obtain an understanding of clinician's perception of decision aids in a primary care setting. Outcome measures and analyses will be blinded.

Eligibility Criteria:
Inclusion Criteria:

* Patient on the active roster of physicians of MUSIC (McMaster University Sentinel and Information Collaboration; McMaster Family Health Team).
* Due for a mammogram (have not had a mammogram ≥ 18 months) according to Canadian screening interval recommendations for routine screening.

Exclusion Criteria:

* Previous history of invasive or non-invasive breast cancer.
* At higher risk for breast cancer compared to the general population i.e. identified as having the BRCA1 or BRCA2 gene, immediate family member has had breast cancer.
* Have had a mammogram within the last 18 months (\< 18 months).
Early Assessment of QFR in STEMI-II

The study intends to provide new data on whether the noval method using quantitative flow ratio could assess microvascular dysfunction based on the previous study EARLY-MYO-QFR-I.

Microvascular dysfunction (MVD) is a serious complication of PCI, which happens frequently after STEMI and always correlates with a poor prognosis. However, precise and simplified assessment of MVD is difficult, especially in the acute phase of STEMI patients. Resent studies suggested that FFR could be overestimated when MVD exists. But whether the overestimated value of FFR caused by CMR defined microvascular obstruction (MVO) could reflect microvascular function is still unclear.

In the previous study EARLY-MYO-QFR-I, we have demonstrated that the relationship between Contrast-enhanced CMR defined MVO and QFR. While angiography images were collected on a retrospectively manner, and the study population were selected (STEMI patients with spontaneously recanalized culprit vessel before PCI) to verify our hypothesis.

This phase of study would be a prospective study. We tend to created a new study population by a temporary artificial stenosis inside the stent by partially inflating a balloon catheter during pharmacologic hyperemia in STEMI patients.

Eligibility Criteria:
Inclusion Criteria:

* STEMI patients treated with revasculation within 12 hours from onset of symptoms to PCI time and received CMR 5 days afterwards. STEMI was defined as a combination of the following: chest pain for more than 30min, electrocardiographic (ECG) changing with ST segment elevation of \>2 mm in at least 2 precordial leads and \>1 mm in limb leads, and abnormal troponin levels or CKMB levels higher than twice the upper limit of normal.
* Stents were implanted whenever technically possible.
* TFG 2/3 after PCI.

Exclusion Criteria:

* Patients with left bundle branch block in the presenting ECG, cardiogenic shock, previous PCI or bypass surgery, previous AMI history.
* Patients with trouble in partially inflating a balloon catheter during pharmacologic hyperemia.
* Patients with unqualified coronary angiographic images with problems such as ostial lesion, severe vessel tortuosity and diffuse long lesions.
Paclitaxel, Carboplatin and Gemcitabine in the Treatment of Patients With Advanced Transitional Cell Cancer of the Bladder

This trial will evaluate the efficacy and safety of combination chemotherapy (paclitaxel, carboplatin, and gemcitabine) prior to surgery in the treatment of patients with locally advanced transitional cell cancer of the bladder.

This is a Phase II trial of neoadjuvant chemotherapy with paclitaxel, carboplatin and gemcitabine in the treatment of locally advanced transitional cell carcinoma of the bladder. Patients will be stratified based on extent of disease. Patients with T3, N0 disease will receive 3 cycles of chemotherapy and then proceed to cystectomy. Patients with T4 disease or any patient with N1-3 disease will receive 3 cycles of therapy followed by assessment of response. Patients with evidence of response will then receive an additional three cycles of therapy with reassessment of resectability after cycles #6. Correlative Studies: Tumor specimens obtained at initial biopsy will be assayed for expression of p53, Rb and p21.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically proven locally advanced (T3-4, N0 or Tany, N1-3) urothelial carcinoma of the bladder. Patients with local disease and unilateral or bilateral hydronephrosis will be eligible and included in the T3 arm of the study.
* Tumor specimens must be available for assay of molecular markers.
* ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 2 (a measure of general well being where 0 is asymptomatic and 5 is death)
* Life expectancy of 12 weeks or more
* Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

* Patients may not have had prior systemic or intra-arterial chemotherapy and no prior radiotherapy (Patients may have received intravesicular chemotherapy).
* Evidence of distant metastasis
* Unresolved bacterial infection
ctDNA as a Assisted Diagnosis, Early Intervention and Prognostic Marker for Peritoneal Metastases From Colorectal Cancer

This is a prospective, open-label, randomized controlled clinical trial, by monitoring the serum ctDNA mutational profile using NGS, aiming to elucidate the correlation between the postoperative ctDNA status and the assisted diagnosis, early intervention and prognosis for colorectal cancer peritoneal metastases.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be a man or woman of at 18-75;
* Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-21；
* Patients with primary colorectal cancer proven by pathology；
* Patients with high risk factors for peritoneal metastasis (simultaneous peritoneal metastasis, ovarian metastasis, PT4, CT4, tumor perforation, tumor-complete intestinal obstruction, mucinous adenocarcinoma/signet ring cell carcinoma of PT3, positive surgical margin, and tumor rupture and hemorrhage);
* 6-12 months after colorectal cancer radical surgery, patients who have two consecutive positive ctDNA tests within one month;
* Patients who have finished standard adjuvant therapy after surgery; (Choose 5-FU or 5-FU analog-based chemotherapy regimen, and the perioperative chemotherapy should not exceed 6 months)；
* Patients who are negative of recurrence or metastasis in conventional oncology examination (serology, endoscopy, imaging) ;
* Written informed consent must be obtained from patients and ability for patients to comply with the requirements of the study.

Exclusion Criteria:

* Patients who were diagnosed with other malignant tumors within 2 years before diagnosis of colorectal cancer;
* ASA class Ⅳ to Ⅴ;
* Patients who have other existence of distant metastasis outside the abdomen;
* Patients with serious mental illness;
* Patients with severe cardiovascular disease, uncontrollable infections, or other uncontrollable co-diseases;
* Patients who cannot be followed up as scheduled;
* Patients who participated in other clinical studies within 3 months prior to the trial;
* Pregnant or nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception.
Study of VGA039 in Healthy Volunteers and Patients with Von Willebrand Disease (VIVID)

The VIVID study is structured in a master protocol format comprised of multiple parts that evaluate intravenous (IV) and subcutaneous (SC) VGA039 in healthy volunteers and subjects with von Willebrand Disease (VWD) and other bleeding disorders.

This first-in-human study consists of 5 parts based on the subject population. Part 1 is a randomized, double-blind, placebo-controlled, single-ascending dose (SAD) evaluation of IV or SC VGA039 or placebo in up to 8 cohorts in healthy volunteers. Part 2 is an open-label, SAD of SC or IV VGA039 in up to 8 cohorts in subjects diagnosed with VWD. All participants will be enrolled, treated, and followed up for 15 weeks (IV SAD) or 8 weeks(SC SAD). Part 3 is an open-label, Phase 1b study of SC multiple doses (MD) of VGA039 in up to 4 cohorts. Part 4 is an open-label, Phase 2 study of SC single, surgical prophylaxis (SP) doses of VGA039 administered prior to a minor surgical procedure in subjects diagnosed with VWD in up to 2 cohorts. Part 5 is an open-label extension (OLE) study of SC MD of VGA039 in eligible subjects diagnosed with VWD who have previously participated in a VGA039 interventional trial.

Eligibility Criteria:
Key Inclusion Criteria (All Subjects)

* Subjects, 18 to 60 years of age, inclusive for Parts 1 and 2
* Subjects, 12 to 60 years of age, inclusive for Parts 3 and 5
* No clinically significant laboratory, ECG, or vital signs results.

Additional Key Inclusion Criteria (for Subjects in Part 1 Only) • Body mass index of 18-32 kg/m2

Additional Key Inclusion Criteria (for Subjects in Part 2 Only)

* Subjects with VWD who are symptomatic, defined as having a history of bleeding or bruising.
* Hemoglobin level ≥ 8 g/dL and platelet count ≥ 150 × 109/L at Screening.

Exclusion Key Criteria (All Subjects)

* Use of hormonal contraceptives within 56 days prior to administration of the study drug.
* Subjects with detection of FV Leiden or Prothrombin G20210A mutation, protein C or S deficiency, antithrombin deficiency, or antiphospholipid antibody syndrome at Screening.
* Subjects with other known pro-thrombotic disorders or abnormal findings in any prior laboratory thrombophilia evaluation.
* History of arterial or venous thrombosis, including superficial thrombophlebitis, or embolism.
* Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, or metabolic dysfunction.

Additional Key Exclusion Criterion (Subjects in Part 1 Only)

• Baseline FVIII activity \> 150 IU/dL.

Additional Key Exclusion Criteria (Subjects in Parts 2, 3, 4 and 5 Only)

* Baseline FVIII activity \> 50 IU/dL.
* Any acute, clinically significant bleeding event requiring surgical or procedural intervention within 7 days prior to receiving study drug.
Suppression Of Atrial Fibrillation With Ranolazine After Cardiac Surgery

The objective of this study is to show that ranolazine is a safe, viable and potent alternative for post-operative atrial fibrillation suppression in patients undergoing cardiac surgery

A single center, double blind, prospective, randomized study for patients who are scheduled for elective cardiac surgery (Coronary Artery Bypass Graft \[CABG\], or valve or CABG and valve). All patients who meet criteria will be prospectively enrolled in a randomized fashion. Patients enrolled will be assigned to receive twice daily identical capsules containing either placebo or ranolazine. Study drug will be initiated 2 days before surgery. Patients will receive study drug throughout their hospitalization and be kept on it for a full 2 weeks post operatively. Patients will be seen in 2 weeks and receive a 30 day follow up contact visit.

Eligibility Criteria:
Inclusion Criteria:

* Indications for cardiac surgery (CABG, valve surgery or CABG and valve surgery, Able to provide informed consent.

Exclusion Criteria:

* Documented atrial fibrillation within the previous 3 months
* Ongoing therapy with suppressive antiarrhythmic drugs
* Patient currently on digoxin
* Emergent surgery
* Patient receiving hemodialysis
* Concomitant use of ketoconazole, diltiazem, verapamil
* Known tolerance or hypersensitivity to ranolazine
* Pregnant individuals
* MAZE procedure (is a surgical ablation to treat atrial fibrillation) performed during concurrent cardiac surgery
Mechanical Ventilation in Severe Brain Injury: The Effect of Positive End Expiratory Pressure on Intracranial Pressure

The purpose of this study is to collect physiologic data from patients with severe brain injury who require mechanical ventilation in order to describe the impact of ventilation, specifically positive end expiratory pressure (PEEP), on intracranial pressure (ICP).


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe brain injury (GCS 8 or less)
* Receiving mechanical ventilation
* Receiving intracranial pressure monitoring

Exclusion Criteria:

* Esophageal varices
* Esophageal trauma
* Recent esophageal surgery
* Coagulopathy (Platelets \< 80k or INR\> 2 )
* Other contraindication for esophageal manometry
* Already receiving PEEP \> 15 cmH2O at enrollment
* Intracranial hypertension (defined as ICP \> 20 mmHg)
* Decompressive hemi-craniectomy
Clinical Study of Donor EBV-CTL Infusion in Patients With CAEBV and EBV-HLH After Allo-HSCT

To evaluate the efficacy and safety of donor EBV-specific T lymphocytes (EBV-CTL) infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)

Evaluate the efficacy and safety of donor EBV-specific T lymphocytes (EBV-CTL) infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)

Eligibility Criteria:
Inclusion Criteria:

1. Patients with CAEBV or EBV-HLH who were eligible for allogeneic hematopoietic stem cell transplantation agreed to regular monitoring of EBV-DNA after transplantation.
2. Age ≤65 years old, ECOG score 0-2.
3. Organ function: Cardiac EF≥40%, creatinine clearance ≥50%, aminotransferase (ALT/AST) \< 200U/L.
4. The estimated survival time is more than 3 months. 5) Have donors who meet the requirements of allogeneic hematopoietic stem cell transplantation donors， and the donor agreed to collect lymphocytes to prepare EBV-CTL

Exclusion Criteria:

1. The patient or donor had a New York Heart Association (NYHA) score of grade II or higher (including grade II). Or a definite diagnosis of cirrhosis.
2. There are active infections other than EBV that have not yet been controlled.
3. The donor has a blood-borne infectious disease (e.g. HIV, hepatitis B, hepatitis C, syphilis, etc.). The patient was positive for HBV-DNA or HCV-RNA.
4. Active major hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.).
5. The donor refused to collect lymphocytes to prepare EBV-CTL cells, or the number of EBV-CTL cells prepared from the donor did not meet the infusion requirements.
6. At the same time participate in other clinical studies.
The Study to Compare Cypher Versus Cypher Select in Treating Cornary Artery Lesions.

The main objective of this study is to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent in reducing angiographic in-stent late loss in de novo native coronary lesions as compared to the CYPHER ™ Sirolimus-eluting Coronary Stent.

This is a multicenter (up to 10 sites), open, prospective, 2-arm, unbalanced, randomized study designed to assess the safety and effectiveness of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent as compared to the CYPHER™ Sirolimus-eluting Coronary Stent. A total of 100 patients will be entered in the study and will be randomized on a 2:1 basis to the CYPHER SELECT™ stent or the CYPHER™ stent. 100 patients with de novo native coronary artery lesions \<23 mm in length and more than 2.5 to less than 3.5 mm in diameter by visual estimate who meet all eligibility criteria will be either randomized.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B\&C, I-II-III) OR patients with documented silent ischemia;
2. Single treatment of de novo lesion in a coronary artery which can be appropriately covered by a study stent up to 23mm in length in patients with single or multivessel disease; patients with multiple lesions can be included only if the other lesions are successfully treated before the target lesion;
3. Target lesion is more than 2.5 and less than 3.5mm in diameter (visual estimate);
4. Target lesion is located in a native coronary artery with a maximum lesion length that can be adequately covered by a single 23 mm stent;
5. Target lesion stenosis is \> 50% and \< 100% (visual estimate).

Exclusion Criteria:

1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
2. Unprotected left main coronary disease with more than 50% stenosis;
3. Significant (\>50%) stenoses proximal or distal to the target lesion that might require revascularization or impede runoff;
4. Have an ostial target lesion;
5. Angiographic evidence of thrombus within target lesion;
6. Calcified lesions which cannot be successfully predilated;
7. Ejection fraction less than 30%;
8. Totally occluded vessel (TIMI 0 level);
9. Direct Stenting;
Low Dose Whole Lung Radiotherapy for Older Patients With COVID-19 Pneumonitis

Low dose whole lung radiotherapy may improve survival of older patients with COVID-19 pneumonitis

Background: Coronavirus disease 19 (COVID-19) carry a high mortality rate among older patients and minorities such as ethnic Africans and Latinos. The chronic baseline systemic inflammation of older patients and minorities may make them more vulnerable to the cytokines storm generated by the viral infection in addition to preexisting co-morbidity.

Even though multiple organs failure result from the cytokine storm, pneumonia and respiratory failure often lead to death. Low dose whole lung radiotherapy (LDWLRT) may modulate the inflammatory response and may decrease the need for artificial ventilation, thus improving mortality rate.

Methods: A phase I-II prospective trials enrolling 500 patients, 65 years old or older from 26 countries will be conducted to investigate the impact of LDWLRT on mortality rate of COVID-19 patients. The patients who will be selected would have developed pneumonias but did not require artificial ventilation. These patients will be followed for a year after receiving this treatment. Their physical activities will be monitored through the ordinal scale and will be correlated with their cytokines status and oxygen saturation rate to assess the impact of the residual inflammation on their daily life. Mortality rates between different ethnic group will be compared and correlated with their cytokines response to the virus and number of co-morbidities.

Discussion and importance of the study: We postulate that LDWLRT may improve survival rates of all patients by preventing the need for artificial ventilation which is associated with a high mortality. The inflammatory response between different ethnic groups before and following radiotherapy will be valuable to serve as baseline for future prospective pandemic studies as it has not been reported before.

Eligibility Criteria:
Inclusion Criteria:

* 65 years-old or older patients with proven COVID-19 pneumonitis who may or may not require oxygen

Exclusion Criteria:

* Patients with pneumonia who do not have a diagnosis of COVID-19 infection, patients with COVID-19 pneumonitis who require artificial ventilation or hemodynamically unstable to undergo radiotherapy or consent cannot be obtained either through the patient or power of attorney or patients already enrolled in another clinical trial
Virtual Reality's Role in See&Treat Hysteroscopy

The aim of the study is to evaluate the feasibility and effectiveness of virtual reality technology in outpatient hysteroscopy to improve pain and anxiety management and spread the diffusion of see \& treat philosophy.


Eligibility Criteria:
Inclusion Criteria:

Exclusion Criteria:

-
Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity

INSPIRE creates a trilingual mobile app and telehealth coaching program to promote non-pharmacologic strategies for pain management with Black, Chinese, and Latinx communities in the San Francisco Bay Area. Years 1-2 will develop the app and test it with a brief single arm pilot starting in Nov 2023. A full two arm randomized controlled trial (RCT) will being in early 2025 with changes in PEG scores as the primary outcome. Secondary outcomes include Helping to End Addiction Longterm (HEAL) common data elements.


Eligibility Criteria:
Inclusion Criteria:

1. age 18 or older
2. speak English, Spanish, or Cantonese
3. have a UCSF Health or SFHN PCP
4. be willing to use a smartphone (iOS or Android - either their own or one provided by the study)
5. have chronic, non-malignant pain for at least 3 months
6. be willing to participate in a 12 month patient-centered chronic pain management study where they will be randomized into one of two comparison arms

Exclusion Criteria:

* Severe mental illness or other condition preventing informed consent