cyrilzakka/clinical-trials huggingface dataset:
Skin Cancer in Swiss Transplant Cohort Study

It's known that organ transplant recipients with long-term drug-induced immunosuppression have a increase of the life-time incidence of squamous cell carcinoma. This study will analyze the incidence and type of skin cancer in the Swiss Transplant Cohort Study and the association with exposure to immunosuppressive and antiinfective drugs and other parameters like age or gender of organ transplant recipients.

Organ transplant recipients with long-term drug-induced immunosuppression have an increase of the life-time incidence of squamous cell carcinoma and are also affected at an earlier age than the general population. In organ transplant recipients prognosis of squamous cell carcinoma differs due to more rapid growth, less differentiation and higher risk for metastases in comparison to the general population. Epidemiological data indicate that the risk of skin neoplasms in organ transplant recipients is related to the cumulative exposure to immunosuppressive drugs over time. It remains unclear wether this risk differs between drug classes.

This study is a prospective observational cohort study of kidney, heart, lung, liver, pancreas and small bowel transplant recipients enrolled into the Swiss Transplant Cohort Study (STCS).

Since 2008 almost all organ transplant recipients in Switzerland are enrolled to the STCS. The STCS collects

* baseline patient and case data: date of transplantation, age, gender, type of transplanted organ, past immunosuppression
* follow-up patient and case data: organ rejection with type and date of rejection, type of immunosuppression in response to organ rejection, graft loss with date of graft loss, immunosuppressive drug treatment, other drug treatment, death, drop out, occurrence of cancer and infections)
* drug exposure data (with start and stop dates): induction immunosuppressive drugs (Basiliximab, Rituximab, Thymoglobulin, ATG, ATGAM, IG iv, Plasmapheresis), maintenance immunosuppressive drugs (Cyclosporine A, Glucocorticoids, Tacrolimus, Mycophenolate mofetil, Everolimus, Azathioprine, Sirolimus, EC-MPA), infectious disease prophylaxis (e.g. TM-Sulfamethoxazole, Valaciclovir, Fluconazole, Atovaquone, Voriconazole, Quinolone), other drugs (e.g. Statins, beta-Blockers, oral antidiabetics).

The investigators will statistically illustrate the incidence, prevalence and type of skin neoplasms in the STCS. The investigators will show the association of the incidence of skin neoplasms and the exposure to different immunosuppressive drugs, other drugs and other parameters in the STCS (e.g. age, gender).

Eligibility Criteria:
Inclusion Criteria:

* solid organ transplant recipients within the STCS
* patients with multiple organ transplantations will be included as well
* patients within the STCS, who gave the informed consent to use their data
* patients with graft loss will remain in the study, since they remain at risk of skin cancer development

Exclusion Criteria:

* organ transplant recipients of non-solid organs (e.g. hematopoetic stem cell transplantation) within the STCS
An Information-Motivation-Behavioral Skills (IMB) Intervention to Promote Human Papillomavirus Vaccination Among Women

HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's risk for cervical cancer, vaccination rates remain inadequate. This study explored the utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV vaccination knowledge, motivation, and behavioral skills among college aged women.

HPV infections are prominent among college-aged women. Although HPV vaccines decrease women's risk for cervical cancer, vaccination rates remain inadequate. This study explored the utility of an Information-Motivation-Behavioral Skills intervention in promoting HPV vaccination knowledge, motivation, and behavioral skills among college aged women.

Methods: Participants were randomly assigned to a single-session intervention or attention-control arm and were assessed at pre-intervention, post-intervention, and at 1-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in a psychology course at the University of Connecticut

Exclusion Criteria:

* Completion of the HPV vaccination series
FlowTriever for Acute Massive Pulmonary Embolism (FLAME)

To evaluate treatment outcomes of patients diagnosed with high-risk (massive) pulmonary embolism


Eligibility Criteria:
Inclusion Criteria:

Age \>=18 years Treatment team determines pulmonary embolism is the cause of shock, and the PE is high-risk per the protocol definitions

Exclusion Criteria:

* Out of hospital cardiac arrest with Glasgow Coma Scale of ≤8
* Witnessed cardiac arrest with ongoing CPR \>30 minutes
* Contraindication to anticoagulants, i.e. heparin or alternative
* Hematocrit \<28%
* Platelets \<25,000/μL
* INR \>8
* Intracardiac thrombus and/or intracardiac clot in transit
* Known anaphylactic sensitivity to radiographic agents that cannot be pre-treated
* History of pulmonary hypertension with systolic pulmonary arterial pressure \>70 mmHg
* Presence of chronic medical conditions with estimated \< 90 days life expectancy per physician discretion (should not consider the current pulmonary embolism and its treatment)
* Current participation in another drug or device treatment study that, in the Investigator's opinion, would interfere with participation in this study
* Patient is known to be COVID-19 positive at hospital admission (patient has active COVID-19)
Safety and Risk of Sensitisation of the rdESAT-6 + rCFP-10 Skin Test Following Repeated Intradermal Administration

The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when injected twice with time intervals of 6 or 12 weeks to healthy adults.


Eligibility Criteria:
Inclusion Criteria:

1. Has signed an informed consent
2. Is willing and likely to be able to comply with the trial procedures
3. Is female/male non-black adult ≥ 18 years and ≤ 55 years of age
4. Is healthy according to a medical examination, medical history and laboratory investigations at inclusion
5. Is prepared to grant authorized persons access to their medical records

Exclusion Criteria:

1. Has a history of tuberculosis or has had a known contact to a person with active tuberculosis
2. Has a positive QuantiFERON-TB Gold In Tube test result at inclusion
3. Laboratory parameters outside of normal range judged by principal investigator to be clinically significant and/or abnormal glucose or protein levels in a urine sample at inclusion
4. Has been in treatment with a product which is likely to modify the immune response within 3 months prior to the day of inclusion (e.g., immunoglobulin, systemic corticosteroids, methotrexate, azathioprine, cyclosporine, infliximab or blood products)
5. Has been vaccinated with a live vaccine within 6 months prior to the day of inclusion (e.g., MMR, yellow fever, or oral typhoid vaccines)
6. Has a known congenital or acquired immune deficiency
7. Has a disease affecting the lymphoid organs (e.g., Hodgkin's disease, lymphoma, leukemia, sarcoidosis)
8. Is known to be infected with HIV, HBV or HCV
9. Has a severe ongoing viral or bacterial infection that might affect the cell mediated immune response at inclusion
10. Has a C-reactive protein (CRP) level \> 50 mg/L
11. Has severe scarring, burn, rash, eczema, psoriasis, or any other skin disease at or near the injection site(s)
12. Has a condition in which repeated blood drawings pose more than minimal risk for the volunteer, such as haemophilia, other coagulation disorders, or significantly impaired venous access
13. Is actively participating in another clinical trial or has participated in previous clinical trials investigating the rdESAT-6 skin test reagent
14. Is pregnant according to urine pregnancy test at inclusion
15. Is a female not willing to use contraceptives or is breastfeeding
16. Has a condition which in the opinion of the investigator is not suitable for participation in the study
Interactive Virtual Telerehabilitation After Total Knee Arthroplasty

The purpose of this clinical trial is to compare the effectiveness of a new interactive virtual telerehabilitation (IVT) system with the conventional program in the rehabilitation of patients after total knee arthroplasty.

Patients are distributed into two treatment groups: 1) Group I (control): standard clinical protocol of TKA rehabilitation consisting of 1-hour sessions for 10 days; and 2) Group II (IVT): 1-hour IVT sessions for 10 days (5 sessions under a therapist's supervision to verify the absence of medical complications + 5 sessions performed at home). The IVT is an interactive virtual software-hardware platform that facilitates the development of remote rehabilitation therapy for multiple diseases. Patients receive information required to perform exercise and the therapist remotely monitors the patient's performance. For the purpose of this trial, the IVT system was designed for lower limb motor recovery in patients undergoing TKA.

Eligibility Criteria:
Inclusion Criteria:

* Post-TKA active range of motion: flexion 80º and extension -10º
* ABsence of stiffness
* Ability to walk with the use of a walking aid
* Ability to read and understand Spanish
* Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation

Exclusion Criteria:

* Sensory, cognitive and/or praxic impairment
* Concomitant medical conditions that may influence the rehabilitation process
* Discharge destination other than home
* Patients with any local or systemic complication (e.g., surgical wound infection, suspicion of deep vein thrombosis...) in the three-month follow-up period
A Study of Sovilnesib in Subjects with Ovarian Cancer

This is a randomized, phase 1b study to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of sovilnesib at different dose levels to establish the Recommended Phase 2 Dose (RP2D) of sovilnesib in subjects with high grade serous ovarian cancer (HGSOC).

This is a randomized, phase 1b dose optimization study of sovilnesib in subjects with platinum-resistant HGSOC. The focus of the proposed clinical study is to establish the RP2D of sovilnesib in HGSOC.

An adaptive multi-cohort design will be used to assess the safety, tolerability, PK, and efficacy of multiple dose levels in parallel to establish the RP2D of sovilnesib. The study will be conducted in 2 parts.

Part 1: 10 subjects will be randomized to each of the open dose levels to generate preliminary PK, pharmacodynamic (PD), safety, tolerability and efficacy data. Early stopping rules for safety based on a Bayesian Toxicity Monitoring Design will be applied.

Part 2: Based on review of the data from Part 1, 20-30 additional subjects will be randomized to 2 or more dose levels examined in Part 1. At the end of Part 2, PK, PD, safety, tolerability and efficacy data will be used to determine the RP2D. Early stopping rules for safety based on a Bayesian Toxicity Monitoring Design and for futility based on a Bayesian Efficacy Monitoring via Predictive Probability Design will be applied.

Sovilnesib will be given orally in 28-day cycles at selected dose levels of interest. Dosing will continue until disease progression, unacceptable toxicity, withdrawal of consent, or other stopping criteria are met.

Eligibility Criteria:
Key Inclusion Criteria:

* All Parts: Age ≥ 18 years, ECOG Performance Status ≤ 1, at least 1 site of measurable disease evaluable by CT scan or MRI per RECIST 1.1, able to take oral medication without alteration
* High Grade Serous Ovarian Cancer, Fallopian Tube or Primary Peritoneal Cancer - histologically or cytologically confirmed; metastatic or unresectable; platinum resistant (defined as recurrence within 6 months of platinum containing therapy) or platinum refractory; prior bevacizumab treatment, or ineligible or intolerant to bevacizumab, or did not receive bevacizumab based on Investigator judgement; if germline and/or somatic BRCA1/2 mutation, previously treated with PARP-inhibitor or ineligible or intolerant.

Key Exclusion Criteria:

* MSI-H, dMMR, POLE gene hotspot mutated, or known hypermutator phenotype
* Endometrioid, clear cell, mucinous, sarcomatoid, low-grade/borderline ovarian tumor or mixed tumors containing any of the above histologies
* Previously received KIF18A inhibitor
* Current CNS metastases or leptomeningeal disease
* Cardiac parameters: MI or stroke ≤ 6 months, unstable angina/PE/DVT/CABG ≤ 6 months, NYHA Class ≥ II, LVEF \< 50%
* Any gastrointestinal condition (e.g. malabsorption syndrome, surgical anastomosis, short bowel syndrome) that might affect the absorption of oral medications including the study drug
Prevalence of Food Allergies to Proteins From Different Legumes

The objective of the study is to assess the prevalence of a sensitization to proteins from legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material (lupin) in atopic and healthy subjects.


Eligibility Criteria:
1. Inclusion Criteria:

   * Male and female subjects
   * Age 18 up to 75 years
   * For group "Atopic": either documented allergy, neurodermatitis, allergic asthma, allergic rhinitis, and/or a positive atopic score based on the criteria of Erlangen (\>10 points).
2. Exclusion Criteria:

   * Intake of antihistamines, tricyclic antidepressants, systemic corticosteroids
   * Acute allergic symptoms
   * Skin infections at the test side
   * Pregnancy, lactation
   * Acute inflammatory diseases
Impact of Race and Re-Transplantation

For children who develop graft failure following cardiac transplantation, retransplantation is often considered. While some centers have reported equivalent results for retransplantation as compared to primary transplantation, this strategy remains controversial. We seek to examine outcomes following re-transplantation in children and identify risk factors for mortality. In addition, adult African-Americans have been reported to have lower survival following heart and other solid-organ transplantation. The relationship of recipient race to survival following pediatric heart transplantation has not previously been reported.

Objective 1: For children who develop graft failure following cardiac transplantation, retransplantation is often considered. While some centers have reported equivalent results for retransplantation as compared to primary transplantation, this strategy remains controversial. We seek to examine outcomes following re-transplantation in children and identify risk factors for mortality.

Objective 2: Adult African-Americans have been reported to have lower survival following heart and other solid-organ transplantation. The relationship of recipient race to survival following pediatric heart transplantation has not previously been reported.

Methods: We would like to review the United Network for Organ Sharing database. We plan on reviewing database records of heart transplantation subjects \<18 years of age from 1987 to 2004. Indications for retransplantation and patient race characteristics will be collected and evaluated. Analysis will be performed using proportional hazards regression controlling for other potential risk factors. The contribution economic disparity, insurance status and HLA mismatching to disparities in outcome will also be explored.

Eligibility Criteria:
Inclusion Criteria:

* orthotopic heart transplantation
* \< 18 years of age

Exclusion Criteria:

-
Monitoring of Nontraumatic Chest Pain Borne by the "Department of Emergency Help Medicalized" (SAMU)

Support pre-hospital chest pain remains a difficult problem in both pre hospital regulation that when supported by the Mobile Services Emergency and Intensive Care (SMUR).

This ground of appeal underlying various pathologies especially acute coronary syndrome whose early care diagnostic and treatment significantly improves the prognosis.

The recognition and management of SCA is therefore a public health issue. Myocardial infarction (MI) is responsible for 10 to 12% of the total annual mortality in adults and coronary heart disease is the leading cause of death in France.

No studies have assessed the adequacy of regulation and management of chest pain SAMU for the diagnosis of SCA.

The main objective of the research is to have a descriptive analysis of the population controlled by the SAMU and the population served by the mobile emergency with chest pain. Also evaluate the adequacy of the proposed direction by the ambulance SAMU/SMUR and the final diagnosis and direction after passing emergency, cardiology and at follow-up to a year.

Course of study:

* Call the ambulance dispatch center: anamnestic data will be collected by the regulator on a medical report forms The patient is identified by an anonymous number, "number of SAMU business". The CRA of Centre concerned, from this number of case (using the database of SAMU) capture, in the database of the French Society of Cardiology - FSC - the patient identification data (name , surname, date of birth, address, telephone number and the name and address of attending physician, these data will be necessary for the CRA to the FSC to follow up to 1 year)
* SMUR: if the patient arrives at SMUR, anamnestic data, clinical, laboratory, ECG, therapeutic, diagnostic and referral will be collected by the contact center on a paper CRF or on the computerized database of CFS by centers.
* Emergency Service: If the patient comes to the ER, the clinical, laboratory, ECG, diagnostic output will be collected on a paper CRF or the computerized database of CFS according to the center by the referent of Centre concerned.
* Cardiology service : if the patient arrives in the cardiology service, laboratory, ECG, diagnostic output will be collected on a paper CRF or the computerized database of CFS according to the center by the referring cardiologist DOLORES center.

Eligibility Criteria:
Inclusion Criteria:

* Patient who called UAS-ACS for a non-traumatic chest pain
* Patient who agreed to participate in the study.

Exclusion Criteria:

* Traumatic grief
* Patient refusal to participate in the observatory
Live Vaccines and Innate Immune Training in COPD.

A randomized, single-blinded clinical pilot study to assess whether vaccination with live attenuated vaccines can induce trained immunity and cause beneficial changes in patients with COPD.

Single-blinded 1:1:1 block randomized controlled trial (with varying block sizes of 3-6), stratified by sex. A total of 60 participants will be recruited and randomly assigned with 20 in each treatment arm. Separated by three months, the participants will receive two doses of one of the following three treatments:

1. MMR vaccine (M-M-R VaxPro)
2. BCG vaccine (Danish strain 1331)
3. Saline (placebo)

Eligibility Criteria:
Inclusion Criteria:

* Specialist verified and spirometry-confirmed COPD
* Age \> 40 years.
* Negative HIV-test.
* Able to give informed consent.

Exclusion Criteria:

* Acute febrile illness.
* Known allergy to BCG or MMR vaccines or serious adverse effects at previous vaccination.
* Allergy to MMR vaccine components, neomycin, or egg proteins.
* Known prior, active, or latent infection with mycobacterium tuberculosis.
* Pregnancy or breastfeeding.
* Vaccination with a live vaccine within the last 4 weeks.
* Being severely immunocompromised (HIV-1 infection, organ- or bone marrow transplantation, chemotherapy, primary immune defect, anti-cytokine therapy, immunosuppressant treatment).
* Oral or intravenous corticosteroid at dose of ≥10 mg/day with duration over 3 months.
* Active solid or non-solid malignancy or lymphoma, excluding basal cell carcinoma within 2 years.
* Treatment with immunoglobulins within the last 3 months or expected treatment with immunoglobulins for the duration of the trial.
The Effects of Fish Oils on Blood Pressure, Heart Rate Variability and Liver Fat in the Polycystic Ovary Syndrome

We hypothesise that fish oils will have a beneficial effect on cardiometabolic parameters in women with PCOS. The purpose of this study therefore is to examine the effects of fish oils on blood pressure, heart rate variability and liver fat content in obese women with the polycystic ovary syndrome.

The prevalence of abnormalities of blood pressure (ABP), variability of heart rate (HRV) and liver fat content is increased in women with the polycystic ovary syndrome (PCOS). We hypothesise that fish oils will have a beneficial effect on these endpoints and other cardiometabolic parameters such as cholesterol and liver function in women with PCOS. This crossover study of 40 obese women with PCOS will therefore examine the effects of fish oils on the above parameters compared with placebo (olive oil). Subjects with PCOS who have participated in previous studies with this research group will be approached for recruitment, as will eligible subjects within the endocrine clinics of the chief and co-investigators.

Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese women with PCOS as per 1990 NIH criteria (see below)
* Non-smokers
* Age\>18 years, premenopausal
* Acceptable to have/be on treatment for type 2 diabetes mellitus and/or dyslipidaemia
* Acceptable to be taking the oral contraceptive pill

Exclusion Criteria:

* Uncontrolled hypertension (BP\>160/100mmHg)
* Known co-morbidities including liver or renal disease
* Already taking fish oil supplements
* Other intercurrent illness (major surgery, CV event)
* Smokers
* Alcohol intake \>20g/day
* Pregnancy
* Any metallic implant (contraindication for MRI).