cyrilzakka/clinical-trials huggingface dataset:
The Effects of Testosterone on Prostate Tissue (ACYP-1)

The purpose of this research study is to understand the effects of testosterone on the prostate. This knowledge will be used to help in the development of a safe male hormonal contraceptive and may impact the development of androgen replacement therapy in older men.

We will be administering two drugs: Testim (testosterone gel) and Acyline. Acyline is an experimental drug. We want to see their effects on levels of hormones in the blood and prostate. In addition, we will be examining the effects of these drugs on the expression of genes within the prostate.

Acyline suppresses LH and FSH, which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore, Acyline blocks testosterone production. In preliminary studies, a single injection of Acyline reversibly lowered the FSH, LH and testosterone levels in the blood for approximately 15 days. Prolonged low levels of LH and FSH cause suppression of sperm production in normal men. However, men may experience some side effects from the low levels of testosterone caused by acyline, thus exogenous testosterone is required to sustain normal male androgen and organ effects without suppressing spermatogenesis. This combination of drugs is a promising male contraceptive regimen. In addition, millions of older men are using testosterone replacement to treat male "andropause"; low level testosterone associated with aging. However, the effect of testosterone on the prostate is unknown. Studies examining the effect of testosterone on the prostate are needed.

Eligibility Criteria:
Inclusion Criteria:

* Males between 35 and 55, normal serum testosterone levels, normal gonadal function

Exclusion Criteria:

* History of prostate cancer, PSA\>2.0, AUA BPH symptom score \>10, History of testosterone or anabolic steroid use, chronic medical illness or prostate disease, active serious infection or immunosuppression, history of a bleeding disorder or need for anticoagulation, abnormal digital rectal exam, abnormal prostate ultrasound, first degree relative with history of prostate cancer
A Study to Learn About the Study Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People With ER+/HER2- Advanced Breast Cancer in China

The purpose of this clinical trial is to learn about the pharmacokinetics. safety and tolerability of the study medicine (called ARV-471) for the potential treatment of advanced estrogen receptor postive and human epidermal growth factor receptor 2 negative breast cancer.

This study is seeking participants have

* ER+/HER2- advanced breast cancer
* received at least 1 line of endocrine therapy with or without CDK4/6 inhibitor
* received up to 2 prior regimens of chemotherapy for advanced setting. All participants in this study will receive ARV-471. ARV-471 will be given by mouth at home once a day. The experiences of people receiving the study medicine will be examined. This will help determine if the study medicine is safe and effective.

Participants will take part in this study until their cancer is no longer responding. During this time, they will have visits at the study clinic about every 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of breast cancer with evidence of ER+/HER2- locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.
* Received at least 1 line of SOC of endocrine therapy with or without CDK4/6 inhibitor for locally advanced or metastatic disease.
* Up to 2 prior regimens of chemotherapy for advanced or metastatic disease setting are allowed.

Exclusion Criteria:

* Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral edema, and/or progressive growth. Participants with a history of CNS metastases or cord compression are eligible if they have been definitively treated (eg, radiotherapy, stereotactic surgery) and clinically stable (including patients with residual CNS symptoms/deficits) off enzyme-inducing anticonvulsants and steroids for at least 28 days prior to first dose of study drug.
* Any of the following in the previous 6 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Class III or IV), cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism or other clinically significant episode of thromboembolic disease, congenital long QT syndrome, Torsade de Pointes, serious conduction system abnormalities (eg, bifascicular block defined as right bundle branch and left anterior or posterior hemiblock, 3rd degree AV block), clinically important arrhythmias, left anterior hemiblock (bifascicular block), ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2, atrial fibrillation of any grade.
Long-term Result of Placing Intracorneal Rings in Keratoconus Using Laser

Intracorneal rings are indicated in patients whose central cornea does not present opacity and whose visual acuity is not satisfied despite correction with lenses or linked to an intolerance to lenses.

Surgeries such as crosslinking and intracorneal rings placement are alternatives to corneal transplantation with the expected effects: stabilization of the disease for corneal collagen crosslinking and visual rehabilitation by the placement of intracorneal rings.

The main objective of this study is to evaluate visual benefit1 year after placement of intracorneal rings using laser in keratoconus


Eligibility Criteria:
Inclusion Criteria:

* Patient having received the information notice/non-objection
* Adult man or woman (over 18)
* Failure of a lens fitting adaptation
* Patient with a diagnosis of keratoconus
* Patient operated at Somain institute with the placement of intra-corneal rings

Exclusion Criteria:

* Minor
* Post-lasik ectasia
* Iatrogenic Keratoconus
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
Implementing Digital Health in a Learning Health System

The need for new models of integrated care that can improve the efficiency of healthcare and reduce the costs are key priorities for health systems across the United States. Treatment costs for patients with at least one chronic medical or cardiovascular condition make up over 4-trillion dollars in spending on healthcare, with estimations of a population prevalence of 100-million affected individuals within the next decade. Therefore, the management of chronic conditions requires innovative and new implementation methods that improve outcomes, reduce costs, and increase healthcare efficiencies. Digital health, the use of mobile computing and communication technologies as an integral new models of care is seen as one potential solution. Despite the potential applications, there is limited data to support that new technologies improve healthcare outcomes. To do so requires; 1) robust methods to determine the impact of new technologies on healthcare outcomes and costs; and 2) evaluative mechanisms for how new devices are integrated into patient care. In this regard, the proposed clinical trial aims to advance the investigator's knowledge and to demonstrate the pragmatic utilization of new technologies within a learning healthcare system providing services to high-risk patient populations.

Objective #1: Determine the effectiveness of handheld imaging and digital health devices on long term health and patient-reported outcomes through pragmatic and randomized clinical trial designs.

Objective #2: Assess the impact of digital health devices and remote patient monitoring (RPM) on measures of healthcare efficiency. Measures of healthcare efficiency directly related to digital health technologies and RPM include: identify which interventions can improve care; define the variations in care and; demonstrate within which patient populations digital health technologies are most effective.

Objective #3: Apply integration methods for handheld imaging and digital health devices used for clinical decisions.

Achieving integration and interoperability-the ability of different information technology systems and software applications to communicate and exchange data with each other-requires identiﬁcation for precisely how new innovations merge into systems of care and are applied to various practice settings.

Eligibility Criteria:
Inclusion Criteria:

* All participants of the ASE 2018 Outreach Event who are at least 18 years old who are referred for a cardiac evaluation

Exclusion Criteria:

* Those not willing to consent
Assessment of Quality of Life in Patients With Symptomatic Chemotherapy-induced Anaemia

This is a multicenter, international, prospective, observational study of patients who are receiving systemic chemotherapy for solid tumour cancers (breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric) and who are receiving darbepoetin alfa (Aranesp®) or other erythropoiesis-stimulating agent (ESA) to treat symptomatic anaemia.

Quality of Life will be assessed electronically with the aim of estimating improvement in quality of life for those patients receiving darbepoetin alfa (Aranesp®) who also have an increase in haemoglobin (Hb) of ≥1 g/dL

Before enrolling participants, each country was assigned to either cohort 1 (patients receiving only darbepoetin alfa) or cohort 2 (patients receiving any ESA). Cohort 2 was assigned only to those countries in which local regulations did not permit observational study participation by patients receiving a specific agent in a drug class.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast, colorectal, ovarian, prostate, lung, bladder, endometrial, renal, pancreatic, esophageal or gastric cancer
* Expected to receive at least 8 additional weeks of a given regimen of myelosuppressive chemotherapy after enrolment
* Starting treatment with either darbepoetin alfa (in Cohort 1 countries) or any ESA (in Cohort 2 countries) as per European Summary of Product Characteristics (SPC) for symptomatic anaemia.

Exclusion Criteria:

* Received any ESA treatment or Red Blood Cell (RBC) transfusion within 28 days prior to enrolment
* Known primary benign or malignant haematologic disorder which can cause anaemia
* Known hypersensitivity to ESAs
The Role of Electrocardiograms in Risk Stratification and Analysis of the Characteristics of ST Elevation in Acute Myocarditis: a 2-centre Study

The purpose of the present study was to investigate ECG findings of patients with acute myocarditis, ECG findings associated with fulminant myocarditis, and the characteristics of ST-elevation on admission.

Acute myocarditis is a severe disease with high mortality rate and various dynamic changes visible on electrocardiograms (ECGs). The aim were to investigate ECG findings in acute myocarditis, ECG findings associated with fulminant myocarditis (FM), and the characteristics of ST elevation at admission. A retrospective analysis of 1814 ECGs was conducted from 274 consecutive patients with acute myocarditis aged ≥13 years, who were hospitalized in two centres between August 2007 and November 2019. All ECG obtained during the hospital course were evaluated by 2 electrophysiologists. A chi-square test was used to evaluate and compare the abnormal ECG findings between the FM and non-FM groups, and multivariate logistic regression analysis was performed to further evaluate ECG findings associated with FM. The Mann-Whitney U test was used to compare the duration of cardiac symptoms before admission for ST elevation at admission.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of Acute myocarditis

  * complete data of ECG

Exclusion Criteria :

* Incomplete data;

  * a history of congenital heart disease, cardiomyopathy or arrhythmias;

    * myocarditis not being the primary diagnosis for a particular admission;

      * absence of cardiac symptoms.
Measles Vaccine: Is There a Protective Role in COVID 19 Pandemic?

The following two mechanisms that explain the ability of measles vaccine to cause partial protection against COVID-19. The first is that measles vaccine may increase the ability of the immune system to fight off pathogens other than measles due to the generated bystander immunity that would enhance the overall immunity against the new coronavirus. The second is that SARS-CoV-2 is proven to have structure similarities with measles, which may cause cross-reactivity and immunity between measles vaccines and COVID-19, leading to partial protection against COVID-19 in vaccinated subjects

Objectives:

1. To identify Measles IgG titre in SARS-COV2 infected patients .
2. correlate level of Measles IgG titre with the clinical severity of COVID-19 disease.

Secondary Objective To find an association of the postulated protective role of measles vaccine and SARS-COV2 infection

Criteria:

Inclusion criteria:included patients would be divided into 3 groups according to clinical severity of COVID-19 disease (mild ,moderate \& severe)

* All patients with confirmed COVID 19 confirmed by positive PCR . .
* Any age or gender.

Exclusion criteria:

- Any patient refusing to be involved in the study.

Methods:

* Informed consent will be taken from each subject
* Full clinical examination.
* Evaluation of Measles Antibody Titer:

The measles virus IgG antibody titer will be determined quantitatively by ELISA for quantitative determination of IgG class antibodies against Measles virus in human serum or plasma (citrate, heparin).

- Anonymous data will be retrieved from the admitted patients' files, such as:

* CBC, CRP, AST, ALT, ESR, Serum ferritin \& SARS CoV 2 RNA PCR swab results.
* Chest X ray and/or CT chest.

Eligibility Criteria:
Inclusion Criteria:

* All patients with confirmed COVID 19.
* Any age or gender

Exclusion Criteria:

* - Any patient refusing to be involved in the study
Comparison of Efficacy and Safety of Norgestimate-ethinyl Estradiol and Cyproterone Acetate-ethinyl Estradiol in the Treatment of Acne Vulgaris

The purpose of this study was to evaluate the effectiveness and safety of norgestimate-ethinyl estradiol as comparted with cyproterone acetate-ethinyl estradiol among female patients with moderate acne vulgaris.

This study was to evaluate the efficacy and safety of TriCilest as comparted with Diane-35 among female patients with moderate acne vulgaris. The study design was double-blind, randomized, parallel and active controlled. The sponsor planned to recruit approximately 50 patients to complete 40 evaluable patients. At the end of the study, a total of 48 patients were randomized.

TriCilest (noregestimate-ethinyl estradiol), 0.18mg-0.035mg or 0.215mg-0.035mg or 0.25mg-0.035mg, Oral admistration, The duration was three consecutive menstrual cycles.

Eligibility Criteria:
Inclusion Criteria:

* Female adults who were suffering from moderate acne vulgaris (grade II or III)
* With 6 to 100 comedones (non-inflammatory lesions)
* With 10 to 50 inflammatory lesions (papules or pustules)
* With fewer than 5 nodules
* Agree to condoms or diaphragm, and spermicide or any other medically approved effective barrier method of contraceptive or a nonhormonal IUD
* Agree to take as treatment for acne only for the supplied study drug during the three month treatment phase
* Documented by an informed consent to participate in the trial on the day before entering the study

Exclusion Criteria:

* Patients who, in the investigator's opinion, cannot understand or follow the instructions given in the study
* Who are pregnant or nursing
* Who have clinical depression and are suicidal or require immediate treatment for depression
* Who have a known hypersensitivity to any of the ingredients
* Who are currently having significant adverse experiences from ethinyl estradiol or norgestimate
* Who have any coexisting medical condition or are taking and concomitant to a medication that is likely to interfere with safe administration of TriCilest and/or Diane-35, in the investigator's opinion
* Who take systemic retinoids, systemic antimicrobials, and topical acne treatments within 6 months, 1 month, and 2 weeks prior to enrollment, respectively
* Who have any of the following contraindications to oral contraceptives: Current thrombophlebitis or thromboembolic disorders, or past history of deep vein thrombophlebitis or thromboembolic disorder, or cerebral vascular or coronary artery disease or known severe hypertension, or diabetes with vascular involvement, or known or suspected carcinoma of the breast, or known or suspected estrogen-dependent neoplasia, or undiagnosed, abnormal genital bleeding, or benign or malignant liver tumor, or have jaundice or severe liver disease, or neurovascular lesion of the eye or serious visual disturbances, or known allergic reaction or sensitivities to TriCilest or Diane 35
* Who have taken an investigational medication within 30 days prior to enter study (or within a period of five times its half-life or the half-life of its metabolites)
Prevalence and Risk Indicators of Peri-implant Diseases in China

The goal of this multicenter cross-sectional study is to investigate the prevalence of peri-implantitis in China. The main questions it aims to answer are:

* What is the prevalence of peri-implantitis in China
* What are the risk indicators of peri-implantitis in China

Participants will be invited to a free-of-charge clinical and radiographic examination of conventional dental implants present for over 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Patients having at least one rough surface titanium implant in function for more than 5 years
2. Patients treated between January 1, 2013 and December 31, 2017
3. All the implants osseointegrated in the patients' mouth at the time of the examination (including those placed in external clinics) and having at least 5 years of loading, either proven by dental charts or confirmed by the patients, were evaluated

Exclusion Criteria:

1. Selected patients were invited to participate in the study by telephone calls on the numbers reported in their medical records, and if no response, the patient was not discarded until at least five attempts on different days have been made
2. Periapical and/or panoramic radiographs unavailable
3. History of peri-implantitis and/or peri-implant mucositis treatment
4. Refusal to participate in the study
Universal Germline Testing in the Community

This study seeks to enroll participants who have a diagnosis of a solid tumor cancer and are willing to undergo germline genetic testing for cancer risk. At baseline, patients will be asked to provide 2 types of blood samples: 1 tube for clinical genetic testing and 2 tubes for future research use. A tumor sample from a previous resection or biopsy will also be obtained and sent to the sponsor. The clinician will be asked to provide relevant medical history and demographic information to the sponsor in the form of electronic case report forms.

This study seeks to enroll adult participants who have a diagnosis of a solid tumor cancer and are willing to undergo germline genetic testing for cancer risk using Invitae's Multi-Cancer gene panel. At baseline, patients will be asked to provide 2 types of blood samples: 1 tube for clinical genetic testing and 2 tubes for future research use. A tumor sample from a previous resection or biopsy will also be obtained and sent to the sponsor. The participant's clinician will be asked to provide relevant medical history and demographic information to the sponsor in the form of electronic case report forms at 3 timepoints: 1 month following the results of the participants genetic testing, one year post genetic testing, and 2 years post genetic testing.

Eligibility Criteria:
Inclusion Criteria:

* Patient has consented to germline genetic testing
* Patient has a histologically confirmed diagnosis of a solid tumor cancer
* Patient is willing to release previously collected tissue sample
* Patient is willing to provide research blood samples
* Patient must be at least 18 years of age

Exclusion Criteria:

* Patient is unable to consent.
* Patient with hematologic malignancy
Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America

The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE® FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.
Effects of Curcumin on Vascular Reactivity

The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk

Eligibility Criteria:
Inclusion Criteria:

* 50 to 70 year-old volunteers
* smokers

Exclusion Criteria:

* treated hypertension
* treated hypercholesterolemia
* chronic disease
* vegetarian or other unusual diets
* chronic alcoholism
Effect of Citrate Dialysate on Vascular Calcification

The goal of this study is to determine whether hemodialysis with citrate slows the progression of vascular calcification. Participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. Vascular calcification will be measured on mammograms that will be performed at 6-month intervals and additional blood samples will be obtained at 6-month intervals.

Vascular calcification is a significant problem in dialysis patients that leads to poor outcomes. Currently there is no therapy that directly addresses this problem. Some of the dialysis solutions (dialysates) currently in use contain citrate, a potent inhibitor of calcium precipitation. In particular, citrate can bind to nascent hydroxyapatite crystals and prevent their propagation. Blood citrate levels are greater after dialysis with citrate dialysates than with non-citrate dialysates, which could slow vascular calcification. However, this has never been investigated. Prior research has shown that arterial calcification can be easily detected and reliably measured on routine digital mammograms, with sufficient sensitivity to follow progression. Mammography is more sensitive in detecting arterial calcification than other imaging and associated with far less radiation and cost. This will allow the researchers to detect differences between citrate and non-citrate dialysates in a safe and convenient way. Participants will be dialyzed with one of two standard dialysis solutions, one with and one without citrate, for 12 months and then switched to the other solution for 12 months. Vascular calcification will be measured by mammography every 6 months. The endpoint will be the difference in the rate of progression of breast arterial calcification (BAC) between dialysis with citrate and non-citrate dialysates.

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis patients with BAC on mammograms

Exclusion Criteria:

* current warfarin use
* severe hyperparathyroidism (likely to undergo parathyroidectomy in the next 2 years)
* difficulty controlling serum calcium (likely to require changes in dialysate calcium concentration in the next 2 years)
* life expectancy \< 2 years
* prisoners
* inability to give consent