cyrilzakka/clinical-trials huggingface dataset:
An Electronic Brief Alcohol Intervention for Women Attending a Breast Screening Service (Health4Her)

Alcohol is a major modifiable risk factor for female breast cancer; yet, awareness of this risk remains surprisingly low and is not systematically addressed in healthcare settings. This study aim to test the effectiveness of a co-designed, automated brief alcohol intervention (Health4Her-Automated) in reducing women's drinking intentions, improving alcohol literacy, and reducing consumption.

Alcohol is a major modifiable risk factor for female breast cancer, even in very low amounts. In Australia, alcohol consumption accounts for 6.6 per cent of cases in post-menopausal women, and 18 per cent of breast cancer deaths. Yet, awareness of this risk remains low and is not systematically addressed in healthcare settings. Embedding a brief alcohol intervention within lifestyle information offered to all women attending breast screening provides the opportunity to address harmful drinking in a discrete, non-judgmental way, to prevent alcohol-attributable breast cancer among this at-risk population.

Brief alcohol interventions are short, single-session programs typically offered in general practice settings to gather information on a person's alcohol consumption and, in a non confrontational way, provide strategies and motivate change to reduce consumption and related risk of harm. An automated brief alcohol intervention, self-completed on a device such as an iPad, is a low-cost, labour- and time-efficient approach that overcomes many of the issues of providing intervention within busy healthcare environments.

Building on the previous pilot trial of a prototype brief e-health intervention (which included alcohol-related questions asked by a researcher, and an animation viewed on an iPad that was activated by the researcher), the aim of the current study is to test the effectiveness of a co-designed, automated brief alcohol intervention (Health4Her-Automated) in reducing women's drinking intentions, improving alcohol literacy, and reducing consumption.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 40+ years of age
* Attending routine breast screening
* With or without a breast cancer history
* Reporting any level of alcohol consumption

Exclusion Criteria:

* Not able to read or comprehend English to enable participation
* No access to a computer, tablet or smartphone to complete follow-up assessment
* Women who are pregnant (also an exclusion from breast screening)
* Participation in the pilot Health4Her trial
Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of intravenous (IV) administration of XmAb808 in combination with pembrolizumab in subjects with selected advanced solid tumors and to identify the minimum safe and biologically effective/recommended dose (RD) and schedule for XmAb808.

This is a Phase 1, open-label, first-in-human (FIH), multiple-dose, dose escalation study with cohort expansion at the RD, designed to evaluate the safety and tolerability of XmAb808 in combination with pembrolizumab. This study will be conducted in 2 parts: Part A (dose escalation) and Part B (cohort expansion).

Eligibility Criteria:
Key Inclusion Criteria:

* Part A: Histologically confirmed advanced/metastatic castration-resistant prostate adenocarcinoma, epithelial ovarian cancer, head and neck squamous cell carcinoma, non-small cell lung cancer, urothelial carcinoma, melanoma, renal cell carcinoma, triple-negative breast cancer, or colorectal cancer that has progressed on standard therapies
* Part B: Histologically confirmed advanced/metastatic castration-resistant prostate cancer that is PD1-naïve; head and neck squamous cell carcinoma that is PD1-naïve or has progressed on prior PD1 therapy; or melanoma that is PD1-naïve or has progressed on prior PD1 therapy
* Measurable disease by RECIST 1.1; subjects with prostate cancer who have evaluable disease according to PCWG3 criteria may enroll
* Life expectancy \> 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Key Exclusion Criteria:

* Subjects currently receiving other anticancer therapies
* Any prior treatment with an investigational agent targeting CD28
* History of a life-threatening adverse event related to prior immunotherapy
* Known active central nervous system involvement by malignant disease. Subjects with previously treated brain metastases may participate provided they are radiologically and clinically stable
Intravenous Tranexamic Acid During Rhytidectomy

This is a prospective, randomized, double-blind study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding and postoperative ecchymosis and edema are subjectively rated and complications are noted.

This is a prospective, randomized, double-blind pilot study investigating whether intravenous tranexamic acid has any effect on rhytidectomy surgery, or the subsequent postoperative sequelae. Intraoperative bleeding is rated on a scale of mild, moderate, or severe and given a score of 1-3. Postoperative ecchymosis and edema are subjectively rated by both patient and surgeon on postoperative days 1, 6, and 9 using a similar mild/moderate/severe scale and scored 1-3, respectively. Any surgical or postoperative complications are noted. Scores are aggregated for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Undergoing rhytidectomy surgery at Glasgold Group Plastic Surgery

Exclusion Criteria:

* History of bleeding disorder, history of thromboembolic events, history of seizure, active use of oral contraceptive pills or hormone replacement therapy, participant preference
A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer

Molecular Imaging (MI) uses tracers which emit radiation to provide clinically valuable imaging for patient with cancer. Most current MI agents utilize Fluorine 18 or Gallium 68 as the positron emitter for PET imaging. However, these isotopes have short half-lives which limit the geographic distribution range of tracers made with these isotopes. Copper 61 (61Cu) has a 3.3 hour half-life, which would allow for far greater distribution range following radiotracer production.

This phase I trial will test the safety and effectiveness of a novel MI radiotracer that uses 61Cu as its positron emitting isotope and targets Prostate Specific Membrane Antigen (PSMA) for imaging prostate cancer. A successful trial will provide the ability to advance this novel 61Cu-NODAGA-PSMA radioisotope into phase II trials, as well as open a new paradigm into the production of MI radioisotopes with 61Cu.

This is a phase 1, non-randomized study. Subjects will undergo imaging with 100-300 MBq (2.7-8.1 mCi) of 61Cu-NODAGA-PSMA intravenously (IV), followed by PET/CT imaging 60 (+/- 10) minutes post radiotracer administration. This is a diagnostic imaging study. As the imaging agent will not have a treatment effect, efficacy evaluations that are standard in treatment protocols will not be performed. We expect to enroll 6-10 patients in the proposed study. The sample size is exploratory.

For the primary objective of safety, side effects will be monitored the day of and the day following radiotracer administration. As the PET radiotracer used in this trial is given at a low, imaging dose, serious adverse events are not expected. If a single serious adverse event is identified, then the protocol will be held until reviewed by the IRB.

For the secondary objective of dosimetry, dosimetry will be calculated from PET/CT images and radioactive counts in blood samples by an experience medical physicist.

For the secondary objective of effectiveness, the number of suspected PSMA-positive malignant lesions will be calculated in both the standard-of-care 18F-Piflufolastat PET/CT and the experimental 61Cu- PSMA PET/CT. Positive lesions will be considered to be the foci greater than local background that are not physiologic/benign by location. The percentage of patients with any suspected PSMApositive malignant lesions will be determined for each radiotracer.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy proven prostate adenocarcinoma
2. Age ≥ 18 years
3. ECOG 0 or 1
4. At least one site of PSMA-positive disease on a PSMA-targeted PET/CT performed within 30 days of trial recruitment
5. Creatinine of ≤1.4 or Creatinine Clearance or ≥ 60 mL/minute.

Exclusion Criteria:

1. Known allergy/hypersensitivity to PSMA-targeted imaging agents
2. Other active malignancy, other than the known prostate cancer
Aim 3, Optimizing CRC Screening in Patients With Diabetes in Safety-net Primary Care Settings

This mixed methods study evaluates the effectiveness and feasibility of a multi-level (patient, team, organizations) intervention to optimize CRC screening for patients with diabetes in primary care safety-net settings.

Aim 3 is a hybrid type 2 effectiveness-implementation pilot study in six primary care safety net clinics. This single-arm study uses a pre-post design to evaluate the targeted implementation strategies impact on: (1) preliminary effectiveness and (2) implementation (i.e., feasibility and acceptability) and a mixed-method comparative case study learning evaluation for safety-net primary care adoption and implementation. Implementation strategies that will be tested were developed through a stakeholder engaged, community-based participatory implementation planning approach. This study uses a tailored combination of implementation strategies that include but are not limited to: identification of patient and practice-level barriers, patient education matierals, patient reminders provider/clinical team education, clinical champions, and audit and feedback. The impact of this evaluation will be measure using mixed methods to assess Exploration, Preparation, Implementation factors related to how organizational and contextual variables affect adoption and implementation for targeting CRC screening among patients with diabetes in safety net clinics at 12 months post intervention. Aim 3 surveys 20 clinicians and staff from 6 clinics (n=120) and conducts key-informant interviews with 8 clinic and staff members at pre- and post-implementation (who have participated in the survey; n=96) and evaluates aggregate data for 30 patients across six clinics (n=180).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes mellitus;
* Participants not up-to-date with CRC screening based on electronic health record (e.g. FOBT/FIT in last year; flexible sigmoidoscopy within four years; or colonoscopy within nine years);
* Age-eligible for CRC screening (50-74 years of age);
* Participants in process of undergoing screening are eligible for participation if they have a FIT/FOBT incomplete test ordered for more than six months or a sigmoidoscopy or colonoscopy referral not completed for greater than one year.

Exclusion Criteria:

• Medical conditions not concordant with standard CRC screening intervals (e.g. prior CRC diagnosis, inflammatory bowel disease, renal failure, etc.).
Macular Pigment Density Evolution in Unilateral Wet AMD Versus Non AMD Patients With or Without Lutein and Zeaxanthine Supplementation

•Purpose: Age-related Macular Degeneration ( AMD) is the leading cause of blindness and visual impairment in industrialized countries. The macular pigment, composed of carotenoid derivatives (lutein and zeaxanthin), may play an important role in the occurrence of AMD. An increase in macular pigment following dietary supplementation with lutein and zeaxanthin could allow early treatment with such supplements in subjects with a high risk of AMD, and encourage them to change their eating habits.

•Primary outcome:

Comparative analysis of the density and evolution of the density of macular pigment:

* In patients without any retinal pathology who underwent cataract surgery 1 month previously
* In the non-exudative eye of patients with exudative AMD in one eye by analyzing the density and evolution of the density of macular pigment in the non-exudative eye

  * Secondary outcomes:

Analysis of changes in macular pigment density after taking food supplements (Nutrof Total versus comparator):

* Time taken to reach the maximum plateau of macular pigment density (no increase in density between 2 measurements)
* Time taken to return to the baseline macular pigment density after cessation of supplementation

  * Study design :

Pilot study -Prospective, randomised, double-masked, comparative, multicenter.


Eligibility Criteria:
Inclusion criteria:

* Both genders (male or female), ≥ 55 years of age.
* Patients without any retinal pathology who underwent cataract surgery 1 month previously Or
* Patients with neovascular AMD (Age-related macular Degeneration) in one eye.
* Patients who gave their written consent

Exclusion Criteria:

Exclusion criteria related to the study:

* Intolerance to the tested product
* Change in fundus image
* Patients already taking Nutrof Total or similar supplements containing Lutein and Zeaxanthin
* Allergy to mydriatics

Exclusion criteria for ophthalmologic reasons:

o Ocular diseases or conditions whose presence might interfere with the measurement of optical density of macular pigment (e.g. cataract, diabetic retinopathy, optic atrophy, myopia\> -6.5 Diopters)

Exclusion criteria for systemic reasons:

o Medical or surgical history, disorder or disease (e.g. severe organic disease, acute or chronic: liver disease, endocrine, neoplastic, hematologic, infectious diseases, severe psychiatric disorder, significant cardiovascular abnormalities, etc...) and / or aggravating factors or structural defect, considered as being inconsistent with the study by the investigator.

Exclusion criteria for general reasons:

* Inability of the patient to understand the study procedures and to give informed consent.
* Ward of court
* Patient not covered by the social security scheme
* Pregnancy
Family Welfare Pilot Intervention Study

The purpose of this study was to test internet and mobile-based applications to support motivating lifestyle counseling to promote healthy eating habits of the mothers and their spouses expecting first child. The feasibility of the intervention will be evaluated in the pilot.

Lifestyle habits during pregnancy have long-term effects of baby's as well as mother's health. Pregnancy period is a favorable time for lifestyle changes, as the parents usually have motivation and assets to change lifestyle. Maternity welfare clinic is the place to promote healthy lifestyles because most Finnish families expecting child visit there at regular intervals.

Eligibility Criteria:
Inclusion Criteria:

* All families expecting their child at their standard 8-10 pregnancy weeks welfare clinic visit

Exclusion Criteria:

* Parents are under 18-year-old
* Parents do not speak Finnish
* Parents do not have internet access
Human Immune Responses Toward HIV-1 Envelope Antigens

The primary objectives of this study is to

* Define the envelope-specific B-cell and T-cell responses in humans who have received a St. Jude HIV-1 vaccine.
* Describe mechanisms of HIV-1 envelope processing and consequent B-cell and T-cell activities.

The goal of this protocol is to understand how human lymphocytes respond to HIV-1 antigens in the context of vaccination or infection. This protocol will support understanding of the immune response by providing a source of lymphocytes and serum from selected individuals to study in laboratory based investigations. Blood samples from individuals who have received an HIV-1 vaccine, individuals who are HIV-1-infected, and individuals who are HIV-1-uninfected are requested to: (1) test previously vaccinated volunteers for HIV-1 envelope-specific B-cell and T-cell immune activities, and (2) increase understanding of how the human immune system processes and responds to HIV-1 envelope proteins.

Eligibility Criteria:
Inclusion Criteria:

* Participant is greater than or equal to 18 years of age.
* Participant is in good general health.
* Participant weighs ≥ 110 pounds.
* Participant has hemoglobin \> 12 gm/dL within last 12 weeks.

Group 1 (Vaccinees) only Inclusion Criteria:

* Participant has previously received one of the St. Jude HIV-1 vaccines via enrollment in prior St. Jude HIV vaccine studies.

Group 2 (HIV positive) only Inclusion Criteria:

* Participant is HIV-1 positive by medical record review.

Group 3 (HIV negative) only Inclusion Criteria:

* Participant is HIV-1 negative as determined by HIV ELISA.

Exclusion Criteria:

* Participant is unable or unwilling to give written informed consent.
* Participant is pregnant female.

Group 2 (HIV positive) only Exclusion Criteria:

* Participant is enrolled in other clinical trials that include any blood sampling such that the cumulative blood draws would exceed that established as constituting minimal risk (e.g., more than 550 ml in an 8 week period with collection more frequently than 2 times per week)
Assessment and Prevention of Pain During Ovarian Stimulation in Patients With Endometriosis

Randomized double blinded placebo-controlled trial to evaluate the impact of ovarian hyperstimulation on endometriosis-related symptoms and to evaluate the impact of letrozole use during ovarian hyperstimulation with respect to endometriosis-related symptoms, embryo/egg quality and quantity, and pregnancy rates.

Randomized double blinded placebo-controlled trial to evaluate: (1) the impact of letrozole use during ovarian hyperstimulation with respect to endometriosis-related symptoms, embryo/egg quality and quantity, and pregnancy rates, (2) the impact of ovarian hyperstimulation on endometriosis-related symptoms.

There will be a total of 60 participants, 20 participants with endometriosis randomized to the placebo group, 20 participants with endometriosis randomized to the letrozole group and 20 control patients with no history of endometriosis. Letrozole and placebo medication will be started on the first day of gonadotropin injections and continued until the day of trigger shot. Medication will be restarted the night of egg retrieval and continued for 2 weeks post retrieval. Endometriosis associated symptoms will be evaluated using a survey modeled after the clinical survey developed by the World Endometriosis Research Foundation Endometriosis Phenome and Biobanking Harmonisation Project. Surveys will be administered at baseline ultrasound appointment for controlled ovarian hyperstimulation cycle, the day of trigger shot, 3 weeks following egg retrieval, 6 weeks following egg retrieval and 12 weeks following egg retrieval.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-42 years
* Planning to undergo controlled ovarian hyperstimulation
* Prior diagnosis of endometriosis by one of the following: (1) surgical diagnosis (2) endometrioma on pelvic ultrasound
* Planning to freeze all retrieved oocytes/embryos prior to transfer

Exclusion Criteria:

* Hypersensitivity to letrozole
* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results
Study Evaluating Desvenlafaxine Succinate Sustained Release In Adults With Major Depressive Disorder

The primary purpose of this study is to compare the antidepressant efficacy and safety of two doses of desvenlafaxine succinate sustained release (10 and 50 mg/day) in adults with Major Depressive Disorder. The study will also assess changes in sexual function and general and functional quality of life outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening).
* Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of \>= 20.
* Clinical Global Impressions Scale-Severity (CGI-S) score of \>= 4.

Exclusion Criteria:

* Clinical instability (25% or greater increase/decrease in HAM-D 17 total score from screening to baseline).
* Significant risk of suicide as assessed by clinician judgment, HAM-D 17 and Columbia Suicide-Severity Rating Scale scores Other eligibility criteria also apply.
Swan-Ganz Catheter Insertion

The goal of this prospective randomized controlled study is to investigate the effect of pause of advancement of the Swan-Ganz catheter, which is to check whether the Swan-Ganz catheter arrive exactly at the right ventricle or not, on success rate of final placement and required time in Swan-Ganz catheterization.

The question which the investigators are trying to answer is: Continuous advancement of Swan-Ganz catheter without intended pause in the right ventricle to check whether the Swan-Ganz catheter arrive exactly at the right ventricle will decrease the trial number and required time to success final placement of Swan-Ganz catheter?

Many clinicians pause advancement of Swan-Ganz catheter to check whether the Swan-Ganz catheter arrive exactly at the right ventricle or not.

The hypothesis of this study is that the intended pause during advancement of Swan-Ganz catheter in the right ventricle induce failure in advancing of it into the pulmonary artery, and that it increase the required time for final placement of it into the pulmonary artery.

Eligibility Criteria:
Inclusion Criteria:

* The patients who need to Swan-Ganz catheterization for heart surgeries

Exclusion Criteria:

* Who doesn't agree to enroll
* Who has thrombus in the heart or the vena cavas.