cyrilzakka/clinical-trials huggingface dataset:
The EMPOWER Study: Endometriosis Diagnosis Using MicroRNA

Endometriosis is a complex, heterogeneous disease that may present inconsistently across women. Using disease-specific biomarkers and advanced biostatistics, DotLab is developing a biomarker test to confirm the presence of endometriosis.This is a multi-center, prospective, observational, minimal risk study in women undergoing laparoscopy, laparotomy or other pelvic surgical procedure for endometriosis, infertility or another benign gynecological indication. Participants will undergo 2 study visits for collection of blood and saliva and completion of study questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. Participant is willing and able to provide written informed consent.
2. Participant is willing and able to provide up to 50 mL of blood via venipuncture and comply with all other study and sample collection procedures.
3. Participant is a female aged 18 through 49 years (inclusive).
4. Participant is scheduled to undergo:

   1. Laparotomy or laparoscopy for signs and symptoms of suspected endometriosis. This shall constitute approximately 95% of the participants enrolled.
   2. Laparotomy, laparoscopy, or other procedures including, but not limited to, tubal ligation, lysis of adhesions, hysterectomy for benign condition, myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy for indications including, but not limited to, infertility or benign gynecological indications (e.g., benign pelvic masses, infertility, abnormal uterine bleeding). This shall constitute approximately 5% of the participants enrolled.

Exclusion Criteria:

1. Participant has a history of surgically determined diagnosis of endometriosis (either via visual inspection or histopathology).
2. Participant is a female in a pre-menarchal or post-menopausal state (last menstrual period at least 1 year before Screening and no other biological or physiological cause can be identified) or has been rendered surgically menopausal (bilateral oophorectomy) for at least 6 months at Screening.
3. Participant is pregnant.
4. Participant has an active malignancy.
5. Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
6. Participant has an active pelvic infection or other infections contraindicated for surgery.
7. Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug was or is planned to be administered.
8. Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
Assessment of a Follow-up With Tele-consulting for Patients With Renal Failure Under Peritoneal Dialysis

The objective of the study is to determine whether tele-consulting for the follow up of patients with renal failure under peritoneal dialysis would not increase the risk of experiencing a severe adverse event


Eligibility Criteria:
Inclusion Criteria:

* Patient under peritoneal dialysis for more than three month
* Patient thought to be able to perform peritoneal dialysis alone or with the help of health care professionnals
* Patients or health care professionnals thought to be able to use telemedicine

Exclusion Criteria:

* No DSL Network
* No GSM Network
* Patients who can not express their opposition to the participation to this study because of limited mental abilities
Aromatase (CYP19) Polymorphism Between AI-responsive and AI-resistant Breast Cancer in Korea

Aromatase(CYP19)inhibitor is one of the major antihormonal drug for breast cancer in postmenopausal women. The variation of CYP19 may affect the effect of aromatase inhibitor. However, the incidence of variation of CYP19 in Korea has not known. Therefore, the investigators want to know the incidence of variation of CYP19 and to assess the effect of these variations of CYP19 to aromatase inhibitor users.


Eligibility Criteria:
Inclusion Criteria:

* hormone receptor positiveBreast cancer patient
* postmenopausal women
* first user of aromatase inhibitor

Exclusion Criteria:

* premenopausal
* The patient who take the other antihormonal therapy
* osteoporosis patients
SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections

Our goal is to provide data that will give surgeons and hospitals clear recommendations on the use of NPWT for Cesarean section, abdominal hysterectomy and colon surgeries in patients with diabetes and/or obesity. We also want to understand the patient experience with the dressing so that we can provide information that will enable clinicians to remove barriers to NPWT use. Additionally, we are seeking to use automated electronic medical record decision support to identify patients that will benefit most from the NPWT.

Specific Aim 1: Evaluate the effect of single-use NPWT on SSI rates after C-section, abdominal hysterectomy, and colon procedures in at risk patients.

To address this aim, we will conduct multicenter, stepped-wedge, quasi-experimental trial evaluating use of the PrevenaTM with 125 mm Hg negative pressure for 7 days among obese (BMI \>30) and/or diabetic patients undergoing the procedures of interest. This is essentially a phase IV clinical trial as this dressing has FDA approval for the indicated use.

Specific Aim 2: Investigate the patients' experience of using the NPWT. To achieve this aim, we will survey a sub-set of patients to assess their knowledge of post-operative care, to identify complications associated with NPWT use, and to learn how patients evaluated the device's ease of use, ease of removal, and comfort.

Specific Aim 3: Assess whether real-time decision support through machine-learning modeling can help surgeons identify patients at high risk of SSI who could benefit from NWPT or other post-surgical preventive measures. To address this aim, we will evaluate whether boosted tree modeling techniques can be used "at the bedside" via electronic medical record data feeds to tailor post-operative care and preventive care for specific patients.

Eligibility Criteria:
Inclusion Criteria: Category A and B

A. Patients undergoing any of the below procedures:

1. C-section
2. abdominal hysterectomy
3. colon procedures Surgical procedures selected will be based on NHSN designated ICD-10 PCS codes(14), with the exclusion of laparoscopic procedures.

B. and either of the following medical conditions:

1. obesity, BMI \>30 kg/m2
2. diabetes type 1 or 2 Criteria for a diagnosis of diabetes: Diabetes noted in the problem list or the medical history or Patient is taking a medication as treatment for diabetes, consistent with NHSN criteria(10).

Exclusion Criteria:

1. Age less than 18 years
2. Infection present at the time of the surgery
3. Laparoscopic procedures with incisions \<6cm.
4. Patients using alternative NPWT device other than the PrevenaTM with 125 mm Hg negative pressure
5. Prisoners
Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma

The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma

The incidence of respiratory allergy in the US has increased gradually over the past several years, and current estimates suggest that allergic rhinitis and bronchial asthma affect approximately 20% and 5% of the population, respectively. Rhinitis and asthma frequently coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. Safety concerns with the increased use of inhaled corticosteroids, the heterogeneity of the disease, and poor compliance with asthma medication regimens, point to the need for the development of safe and convenient oral therapies for asthma. Histamine is an important chemical mediator of inflammation in asthma. The benefits of antihistamine treatment in patients with mild to moderate asthma have been well documented, however their clinical use has been previously limited due to the high doses required for efficacy and their associated side effects including sedation and cognitive impairment.

Eligibility Criteria:
Inclusion criteria:

* Males and non-pregnant, non-breastfeeding females 12 through 80 years of age
* FEV1 in the context of this study is greater than 60% and not less or equal to 87% of predicted values at Visit 1 or Visit 2 (and no short-acting agent beta-agonist use within 6 hours prior to spirometry)
* Improvement in FEV1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry OR documented during the previous 12 months at the study site.
* Use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use)

Exclusion criteria:

* Otherwise healthy
Effect of Exercise Training on the Function of the High Density Lipoprotein (HDL)-Cholesterol, Endothelial Function and Endothelial Progenitor Cells in Patients With Metabolic Syndrome(HERMET-Study)

The purpose of the present study is to characterize the quality of HDL-Cholesterol in patients with metabolic syndrome and reduced blood HDL-Cholesterol levels and to examine the effect of exercise training on the vasculoprotective effects of HDL-Cholesterol in these patients. Additionally the investigators aim to investigate the endothelial function, oxidative stress and the regenerative capacity of the endothelial progenitor cells in patients with metabolic syndrome and the changes dependent on physical activity of patients.


Eligibility Criteria:
Inclusion Criteria:

* Reduced HDL-Cholesterol levels in blood: \< 40 mg/dl (1.03 mmol/L) in male, \< 50 mg/dl (1.29 mmol/L) in female
* Plus two of the following criteria:
* Elevated waist circumference: ≥ 102 cm (≥ 40 inches) in men or ≥ 88 cm (≥ 35 inches) in women
* Elevated triglycerides: ≥ 150 mg/dL (1.7 mmol/L
* Elevated blood pressure: ≥ 130 mmHg systolic blood pressure or ≥ 80 mmHg
* diastolic blood pressure or anti-hypertensive treatment
* Elevated fasting glucose: ≥ 100 mg/dL or on drug treatment for elevated fasting glucose

Exclusion Criteria:

* Acute coronary syndrome
* Unstable Angina pectoris
* Myocardial infarction during the last 8 weeks
* Therapy with Niacin
* Active infections
* Ventricular arrhythmias
* Systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 95 mmHg
* Cancer
* Pregnancy, lactation
* Alcoholism
Clinico-biological Collection to Investigate the Physiopathology of Systemic Autoimmune Diseases

The aim of this project is to start a biological and clinical collection of patients presenting systemic autoimmune disease. This collection will provide appropriate biological samples to identify new biomarkers and to be accessible to the medical, scientific and industrial communities for the identification of new therapeutic strategies

Autoimmune diseases group together less than a hundred different clinical entities which are for the most part rare pathologies but which, in combination, concern 5-8% of the adult population with a strong female predominance (FAI²R: the disease chain rare autoimmune and auto-inflammatory drugs, fai2r.org). The common denominator of all these diseases is based on the breakdown of self-tolerance which is the origin of self-reactivity and whose physiopathological mechanisms are still not fully understood, which generates numerous cross-sectional or fundamental studies. In addition to this complexity, there are significant inter-individual variabilities which lead to the definition of subgroups of patients on the basis of the clinical-biological profile and / or the response to treatments. Consequently and in view of the need to establish the diagnosis early and then to propose the best treatment in the perspective of an individualized medicine, the clinical, biological and genetic characteristics of these subgroups of patients must be explored in order to improve diagnostic and therapeutic capacities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rare systemic autoimmune diseases (lupus, scleroderma, myositis for example),
* Patients with atypical presentations of documented or probable systemic autoimmune diseases,
* Patients receiving, or likely to receive new, innovative therapies (new molecule on the market, gene therapy, cell therapy, etc.).

Exclusion Criteria:

* Known anemia and hemoglobin \<10 g / dl
* Patients under protective supervision (guardianship, curators)
* Pregnant or breastfeeding woman
Imjudo & Imfinzi PMS

Based on the re-review of new drugs article, Korean pharmaceutical act, the objectives of this study are to assess safety and effectiveness of the study drugs(Imjudo \& Imfinzi) in a real world setting in patients who treated according to the approved indications in Korea.

Primary Objective:

To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea

Secondary Objective:

To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea

Exploratory Objective:

To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea

Eligibility Criteria:
Inclusion criteria:

1. Patients eligible for the study drugs according to the approved label in Korea
2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion criteria:

1. Other off-label indications according to the approved label in South Korea
2. Current participation in any interventional trial
A Pilot Study of Quantitative Tumor Oxygen Measurements in Cervical Cancer

This research is studying the level of oxygen in tumors during the brachytherapy procedure.

Tumors with low levels of oxygen have been found to be more resistant to standard radiation and chemotherapy treatments. For patients with tumors with low oxygen levels, it is not well known if higher radiation doses can overcome treatment resistance to radiation. Currently, there are limited ways of measuring tumor oxygen levels. The investigators believe that measuring tumor oxygen levels during the brachytherapy procedure will allow the investigators to develop better and improved oxygen measurement techniques, and ultimately improve clinical outcomes for patients, such as better local tumor control.

This research study is a Pilot Study, meaning that this is the first time investigators are examining the oxygen sensor being used. This study is designed to test the oxygen sensor's ability to measure the oxygen levels within the participant's cervical tumor with the aid of magnetic resonance imaging (MRI) scans. MRI scans use magnets to make detailed images of the participant's tumor and the surrounding normal tissues during the brachytherapy procedure.

Eligibility Criteria:
Inclusion Criteria:

* Participants must have a biopsy-proven diagnosis of cervical cancer for which interstitial brachytherapy is planned as standard treatment
* Age 18 years or older
* ECOG performance status of 2 or less (see Appendix A)
* Patients who have received prior radiation or chemotherapy may be enrolled on this study
* Participant is deemed to be an appropriate candidate for MR-guided brachytherapy by the radiation oncologist and the patient elects to be treated with MR-guided brachytherapy
* Participant provides informed consent for prospective collection of relevant medical records for analysis of clinical outcome and treatment-planning techniques
* Ability to understand and the willingness to sign a written informed consent document. Participant is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow- up

Exclusion Criteria:

* Participants who have a contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR-compatible device or implant
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor

The purpose of this study was to evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study also evaluated the safety of ASP0113 in this patient population.

Participants were followed for one year after first study drug injection. This was the primary study period.

Participants were followed for 4.5 years after completion of the primary study to assess long-term safety of the vaccine.

Eligibility Criteria:
Inclusion Criteria:

* CMV negative subject having received a CMV seropositive kidney (living or deceased)
* Participant started valganciclovir or ganciclovir within 10 days of transplant and had received it through Randomization.

Exclusion Criteria:

* Participant underwent a course of CMV-specific prophylactic therapy with antiviral drugs with a duration of greater than 100 days.
* Participant had received from one month prior to transplant or planned to receive CMV immunoglobulin.
* Participant had CMV viremia or CMV disease from time of transplant until time of Randomization.
Marine Protein Hydrolysate as Dietary Supplement in Elderly Part I

The aim of this study is to investigate the potential effect of a marine protein hydrolysate (MPH) supplement before a meal on postprandial glucose tolerance in healthy subjects, to achieve more knowledge on this presumed beneficial, blood glucose lowering effect

To further investigate the effects of MPH in a single dose of 20 mg/kg of body weight on postprandial blood glucose, insulin and GLP-1 (as markers of glucose metabolism) in healthy, active middle-aged to elderly subjects - age 40-65 years.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Body mass index (BMI) 20-30

Exclusion Criteria:

* Suspected allergies against fish or shellfish
* Low or unstable blood pressure
* Diabetes mellitus, treated pharmacological
* Chronic diseases or therapies that is likely to interfere with the evaluation of study results
* Acute infections (may be reconsidered for inclusion at a later time)
* Allergic to milk, confirmed diagnose
* Pregnancy
* Women who are breast-feeding infants
* Inability or unwillingness to comply with the requirements of study procedures
Clinical Observation of ICI Combined With Recombinant Human Endostatin on Leptomeningeal Metastasis of Lung Cancer

immune checkpoint inhibitor combined with recombinant human endostatin can improve the 3-month OS rate of leptomeningeal metastasis of lung cancer, and the combination is safe

We will recruit 20 patients with leptomeningeal metastases from lung cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, gender unlimited;
2. A clear diagnosis of leptomeningeal metastases derived from lung cancer , including positive cerebrospinal fluid cytology and/or neuroimaging diagnosis;
3. A clear history of lung cancer, including histopathological diagnosis, or a combination of cytopathology and imaging;
4. Proper organ function (neutrophil count ≥1.5× 109 /L, platelet count ≥100× 109 /L, hemoglobin concentration ≥90g/L, serum transaminase concentration ≤2.5 times the limit of normal value, serum creatinine concentration ≤ 1.5 times the upper limit of normal value, proteinuria ≤1+)
5. Dexamethasone ≤2 mg (or equivalent) 7 days before the start of treatment in patients requiring long-term use of the hormone
6. Signed the informed consent and was willing to follow the experimental protocol and follow-up

Exclusion Criteria:

1. Patients with positive driver genes and effective treatment, such as patients with positive EGFR gene sensitive mutation
2. Severe infections or serious comorbidities, such as hemorrhagic peptic ulcer, intestinal obstruction, heart failure, kidney failure, or poorly controlled diabetes;
3. Be allergic to PD-1 inhibitor and recombinant human endostatin
4. The female patient planned to be pregnant, was pregnant and lactating -
Cancer Fatigue Education Program

The purpose of the present project is to develop, implement and evaluate a pilot regional patient education program on the management of one of the main side effects of chemotherapy in cancer patients, that is fatigue.

A carer (doctor or nurse) trained in educational techniques will be responsible for the patient. The carer will first identify modes of behavior and competences that the patient must acquire in order to optimize his/her management of fatigue ("educational diagnosis"). An education program, based on a contract of goals will be proposed after this diagnosis phase. The expected results are, in the short-term, a significant reduction in the mean level of fatigue in patients receiving chemotherapy who benefited from individual educational management. In the longer term, the aim is to evaluate the impact of this program on patient quality of life and use of healthcare structures in comparison with conventional management.


Eligibility Criteria:
Inclusion Criteria:

* - Age\> 18 years.
* Patient with histologically confirmed malignancy, during initial treatment with chemotherapy, followed or not by surgery, or the first week of radiotherapy. Patients with hematologic malignancy (including non-Hodgkin's lymphoma or Hodgkin's disease) may be included in the study, except for patients with leukemia.
* Having a fatigue up during the week preceding the inclusion level measured by the average patient with 2 or more on a visual analogue scale (VAS) graded from 0 to 10 (0 expressing no fatigue and 10 the maximum fatigue imaginable ).
* Volunteered to participate in PEPs "Coping with fatigue."
* Usually followed as outpatients.
* Condition preserved (ECOG PS 2).
* Available for all meetings of the educational program (5 sessions of 2 hours over a period of 5 weeks).
* Able to read, write and understand French.
* Resident (s) in a 50 km radius around the center investigator.
* Can be contacted by phone.
* Compulsory membership of a social security system.
* Obtaining informed consent in writing, signed and dated.

Exclusion Criteria:

* - Patient (e) with the inclusion anemia with a hemoglobin level below 10 g/100 mL.
* Patient (e) having a documented history of cognitive or psychiatric disorders.
* Patient (e) can not be followed for family, social, geographical or psychological.
* Patient (e) deprived of their liberty by court or administrative