cyrilzakka/clinical-trials huggingface dataset:
The Effect of Fluid Training Given to Hemodialysis Patients on Interdialytic Fluid Intake and Blood Pressure

The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate.

The research evaluated the effect of nutrition and fluid restriction training on interdialytic fluid intake and intradialytic hypotension in hemodialysis patients. The study sample, conducted with an experimental design, consisted of 71 patients (36 experimental and 35 control) who received dialysis treatment in a private dialysis centre affiliated with the Istanbul Provincial Health Directorate. Fluid Control Scale in Hemodialysis Patients (HHSÖ), Blood Pressure Control Form, Bioimpedance Analysis, Bioimpedance Analysis Compliance Form, Things to Consider Before Bioimpedance Analysis, and Nutrition Booklet for Dialysis Patients were used to collect the data. Parametric methods were used to analyze the data. Differences between the proportions of categorical variables in independent groups were analyzed with Chi-Square and Fisher's exact tests. The t-test was used to compare quantitative continuous data between two independent groups. A dependent group t-test was used to compare intra-group measurements.

After randomization of the experimental and control groups, both groups were measured with the BCM (Fresenius Medical Care Body Composition Monitor) device. The experimental group was given face-to-face fluid restriction training in line with the Nutrition Booklet for Dialysis Patients. At the end of the second month, BCM was measured again in both groups. During the follow-up of the experimental group, training was repeated according to the needs of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* volunteering
* good communication
* chronic kidney failure
* no amputation
* hemodialysis 3 days a week

Exclusion Criteria:

* Heart battery
* dialysis 2 days a week
* more than 200ml of urine
Comparision of EUS-FNB Techniques for Diagnose of Solid Pancreatic Lesions

Studies have shown that the wet-suction technique in EUS-FNA generates better histological diagnostic accuracy and specimen quality than the dry-suction technique. However, studies on wet suction on the diagnostic accuracy of EUS-FNB is small and the conclusions are controversial. Besides, the optional numeber of passes for EUS-FNB has not been determined.

The investigators aimed to design a large multicenter randomized trial to compare the diagnostic accuracy and the optimal number of passes required for EUS-FNB in solid pancreatic lesions using 22G Franseen under wet aspiration versus standard aspiration.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years;
* Patients with solid pancreatic lesions evidenced by CT or MRI who do not have a histopathological diagnosis.
* Plan to receive EUS-FNB.
* Able to obtained informed consent.

Exclusion Criteria:

* Had expected difficulty of endoscope insertion
* That no lesion in the pancreas is identified by EUS
* Use of anticoagulants/antiplatelet drugs that cannot be discontinued.
* Had a bleeding tendency, defined as an international normalized ratio of the prothrombin time \>1.5 or a platelet count \<50,000 cells/mL
* Other medical conditions that render the patient an unsuitable candidate for EUS-FNB.
* Vulnerable groups such as pregnant women or patients with mental disorders;
* Patients unable to understand and/or read the consent form.
Lu177-EB-PSMA617 Radionuclide Treatment in Patients With Metastatic Castration-resistant Prostate Cancer

In prior studies, the investigators synthesized 177Lu-EB-PSMA-617 by conjugating a truncated Evans Blue (EB) molecule and DOTA chelator onto PSMA-617 and labeled it with 177Lu to increase the tumor accumulation and retention for radioligand therapy，and then the investigators evaluated the dosimetry of 177Lu-EB-PSMA-617 and response to single low-dose treatment in patients with metastatic castration-resistant prostate cancer(mCRPC). This study was performed to evaluate the safety and therapy response to 177Lu-EB-PSMA-617 in patients with mCRPC.

This is an open-label, randomized study. Different groups with doses of 1.11GBq (30 mCi), 2.00 GBq (54 mCi) and 3.7GBq (100 mCi)of 177Lu-EB -PSMA617 will be injected intravenously. All patients will undergo 68Ga-PSMA PET/CT scans before and after the treatment.

Prostate cancer (PC) is the second most common cancer worldwide in men, with persistently high numbers dying from this disease. Recent studies have demonstrated the possibility of 177Lu-PSMA-617 therapy as a viable treatment option in mCRPC. To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, the investigators conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA-617) and label it with 177Lu.

The study is open-label and patients will be divided into three groups and monitored throughout the 6 to 10-month treatment period for survival, disease progression, and adverse events to evaluate the safety and therapy response to the 177Lu-EB-PSMA-617.

Eligibility Criteria:
Inclusion Criteria:

* progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy.
* Distant metastases with high PSMA expression confirmed by 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA-617.

Exclusion Criteria:

* a serum creatinine level of more than 150μmol per liter,
* a hemoglobin level of less than 10.0 g/dl,
* a white-cell count of less than 4.0× 109/L,
* a platelet count of less than 100 × 109/L,
* a total bilirubin level of more than 3 times the upper limit of the normal range,
* a serum albumin level of more than 3.0 g per deciliter,
* cardiac insufficiency including carcinoid heart valve disease,
* a severe allergy or hypersensitivity to radiographic contrast material,
* claustrophobia, and pregnancy or breastfeeding.
PCORI-CER-1306-03385 Informed Decisions About Lung Cancer Screening

Educational research study where goal is to test educational materials that help people make informed decisions about lung cancer screening.

This is the second phase of a larger project funded by the Patient-Centered Outcomes Research Institute to help heavy smokers make informed decisions about lung cancer screening with low-dose computed tomography (LDCT). The aim of this phase is to compare outcomes for promoting informed screening decisions about lung cancer screening in a randomized trial of patients who smoke recruited through state-based smoking cessation quitlines, where patients will be randomly assigned to the updated patient decision aid or to standard educational materials on lung cancer screening.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women 55 to 77 years of age.
2. Participants must speak English.
3. Current smoker or quit smoking within the past 15 years.
4. At least a 30 pack-year smoking history.

Exclusion Criteria:

1) History of lung cancer.
Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma

LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo activity in both tumor models. The primary purpose of this study was to determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) in pediatric patients and to delineate a clinical dose to be used in future studies. This study was also to have assessed the safety, tolerability, PK and preliminary evidence of antitumor activity of LEE011 in patients with MRT or neuroblastoma.

Due to lack of efficacy, enrollment in the study was stopped at the end of dose escalation (sites were notified of the early enrollment halt on 7-Aug-2014) and the dose-expansion part was not conducted. Due to halted enrollment and/or lack of complete responses (CR) and partial responses (PR), efficacy analysis was only performed in terms of TTP for the patients treated during the dose-escalation part at the maximum tolerated dose (MTD) and recommended dose expansion (RDE).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of MRT or, neuroblastoma or in dose escalation part, other tumors with documented evidence of D-cyclin-CDK4/6-INK4a-Rb pathway abnormalities (dose escalation part only),
* Patients with CNS disease should be on stable doses of steroids for at least 7 days prior to first dose of LEE011 with no plans for escalation.
* In expansion part, patients must have at least one measurable disease as defined by RECIST v1.1.
* Patients must have a Lansky (≤ 16 years) or Karnofsky (\> 16 years) score of at least 50.

Exclusion Criteria:

* Prior history of QTc prolongation or QTcF \> 450 ms on screening ECG.
* Patients with the following laboratory values during screening:

  * Serum creatinine \> 1.5 x upper limit of normal (ULN) for age
  * Total bilirubin \>1.5 x ULN for age
  * Alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) \> 3 x ULN for age; aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase(SGOT) \> 3 x ULN for age except in patients with tumor involvement of the liver who must have AST/SGOT and ALT/SGPT ≤ 5 x ULN for age. For the purpose of this study, the ULN for SGPT/ALT is 45 U/L.
* Patients who are currently receiving treatment with agents that are metabolized predominantly through CYP3A4/5 and have a narrow therapeutic window and/or agents that are known strong inducers or inhibitors CYP3A4/5 are prohibited. In particular, enzyme-inducing antiepileptic drugs (EIAEDs).
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for the study.
Cardiovascular Imaging and Biomarker Analyses (CIBER)

"Cardiovascular Imaging and Biomarker Analyses (CIBER)" is a single-center, prospective and observational study evaluating the expression of novel biomarkers in patients undergoing cardiacvascular imaging within clinical routine care. It is aimed to evaluate associations with biomarker expressions with ascertained cardiac imaging parameters.

"Cardiovascular Imaging and Biomarker Analyses (CIBER)" is a single-center, prospective and observational study evaluating the expression of novel biomarkers in patients undergoing cardiacvascular imaging within clinical routine care. It is aimed to evaluate associations with biomarker expressions with ascertained cardiac imaging parameters. Furthermore the prognostic value of biomarkers and imaging parameters on mid-term and long-term prognosis will be evaluated. Novel biomarkers will comprise blood derived biomarkers including neurohormones, proteins, cytokines, microRNAs and metabolomics.

Eligibility Criteria:
Inclusion Criteria:

* patients with low to intermediate risk for coronary artery disease

Exclusion Criteria:

* under 18 years
* mechanical heart valve
* pulmonary embolism
* deep vein thrombosis
* myocardial infarction within the last 3 months
* electrical cardioversion within 30 days
* status after heart transplant
* transient ischemic attack (TIA) or stroke within last 30 days
* intracerebral bleeding within the last 2 months
* acute infection
* existing or planned pregnancy
* chronic kidney disease with eGFR \< 40 ml/min
Trial of an Intervention to Improve Metformin Persistence and Adherence

Metformin is a safe and effective first-line drug for type 2 diabetes that is also widely recommended for weight loss and diabetes prevention. But, metformin is associated with gastrointestinal and other side effects which prevent its use in 10-20% of patients and appear to limit the usable dose in others. This study is an N-of-1 trial design that will recruit 20 previously metformin-intolerant patients for re-challenge with metformin in a double-blind scenario. In this setting, 'intolerant' means either unable to take metformin at all, or unable to increase the dose past 1,000 mg despite the treating physician's recommendation to do so. Patients will be assigned to take their baseline medication regimen plus 2 weeks of 250 mg per day of metformin extended release, followed by 500 mg metformin XR, 750 mg, and 1,000 mg metformin XR with each treatment period separated by a 2-week course of placebo. Initial treatment, placebo or metformin XR, will be decided randomly. At the end of each two-week treatment period, participants will complete questionnaires assessing overall satisfaction with the medication, gastrointestinal symptoms, and adherence. Six months after the conclusion of the intervention, patients will be asked if they are continuing metformin at a higher dose than upon entry to the trial. This trial has two aims. First, to test the hypothesis that medication satisfaction will be the same during periods of placebo treatment and during periods of treatment with the active drug. The second aim is to test the hypothesis that \> 30% of metformin-intolerant patients in an N of 1 crossover trial are able to tolerate higher-dose metformin at 6-months.

Results have been presented in a single study arm as the order in which patients received drug or placebo was unique for each patient.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes, pre-diabetes, or obesity
* Previously attempted to take metformin for an above indication
* History of metformin intolerance (defined based on treating physician's assessment that a history of metformin intolerance (defined as the inability, due to side effects, to use metformin at the otherwise medically appropriate dose) exists, confirmed by the patient's recollection of the same history)

Exclusion Criteria:

* Contraindication to metformin (i.e, advanced renal or liver disease, history of metformin attributed lactic acidosis, or advanced heart failure)
* Pregnant women
Evaluation of Serological Techniques for Screening for COVID-19 Infection at the University Hospital of Rouen

At present, the offer of tests for the serological diagnosis of CoVID-19 (detection of IgG, IgM or IgA antibodies against CoV-2 SARS) is plethoric and is based on the use of a very large number of rapid diagnostic unit tests, a few dedicated high throughput automated systems or reagents on existing open systems. The offer will continue to expand in the coming months.

In order to meet the objectives mentioned by the Prime Minister, and confirmed in the HAS report of April 16, 2020 and in the opinion n°6 of the COVID-19 scientific council concerning the potential use of these serological tests at the end of the COVID-19 epidemic, the Virology laboratory wishes to validate the sensitivity and specificity of the tests it intends to use.


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria in the retrospective "Negative/Potentially Interfering" group are as follows :

* Adult patient sampled prior to the onset of the COVID-19 epidemic (before January 2020)
* Patient presenting a coronavirus infection other than SARS-CoV-2, or other respiratory viral infections (influenza, metapneumovirus)
* Patients for whom a serum is kept in the biocollection declared under the number AC-2014-2293 and kept in the Institute of Clinical Biology, University Hospital of Rouen.

The criteria for inclusion in the "acute point infection" group are as follows:

* Patients screened by a positive RT-PCR for an SARS-CoV-2 infection
* Patients aged ≥ 18 years old
* Patients taken in charge in the emergency room / in a unit / in COVID resuscitation at the Rouen University Hospital.
* Patients having read and understood the briefing note
* Non-opposition to participation in the study

The criteria for inclusion in the "Sequential acute infection" group are as follows:

* Patients with positive RT-PCR for CoV-2-SARS infection
* Patients aged ≥ 18 years old
* Taken care of in a COVID unit at the Rouen University Hospital
* Having read and understood the briefing note and signed the informed consent form

The criteria for inclusion in the "Convalescent" group are as follows:

* Caregivers working at the UH of Rouen
* Screened by positive RT-PCR for SARS-CoV-2 infection,
* Healed for at least one month at the time of inclusion
* Having read and understood the briefing note and signed the informed consent form

Exclusion Criteria:

* Minor person
* Known Pregnancy
* Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection / subtutorship or guardianship
* Person not affiliated with social security
* Person who does not understand and speak French
Expanded Noninvasive Genomic Medical Assessment: The Enigma Study

In January 2007, the American Congress of Obstetricians and Gynecologists (ACOG) revised its guidelines that now recommend physicians are ethically obligated to fully inform all pregnant women that screening for fetal chromosomal abnormalities including biochemical screening tests and invasive procedures such as CVS or amniocentesis is available, regardless of age. Further, it is entirely up to the patient to decide whether or not she wishes to be screened for fetal chromosomal abnormalities without judgment from the physician.

Noninvasive laboratory-developed tests (LDTs) that detect an abnormal amount of maternal and fetal DNA in an expectant mother's blood sample (known as circulating cell-free DNA) are now available. These LDTs have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although LDTs to date have not been subject to U.S. FDA regulation, certification of the laboratory is required under the Clinical Laboratory Improvement Amendments (CLIA) to ensure the quality and validity of the test.

To sample collection study will obtain whole blood specimens from pregnant subjects to be used for development of prenatal assays to assist in the screening for fetal genetic abnormalities, infectious and other diseases, and blood group typing through detection of circulating cell-free DNA extracted from maternal plasma.

Eligible subjects will provide written informed consent after which basic demographic and clinical data will be collected.

Study procedures involve the collection of 50 mL of whole blood at one or more monthly clinic visits (≥25 days apart) from pregnant women (18 to 54 yrs of age) carrying a single fetus of 8 to 22 weeks of gestational age inclusive.

Eligibility Criteria:
Inclusion Criteria:

* Subject is willing to provide informed consent and comply with study procedures
* Pregnant female, 18 to 54 years of age carrying a singleton fetus of 8 to 22 weeks gestational age
* Willing to provide a study blood sample in accordance with the protocol
* Willing to allow access to her medical records to collect pregnancy outcome information
* Willing to provide consent for release of fetal karyotype if an invasive procedure (CVS or amniocentesis) is performed during the pregnancy
* Subject is known to be at risk for one or more of the following:
* fetal gene and chromosome abnormalities (e.g., T21, T18, T13, microdeletion syndromes, sex chromosome abnormalities)
* congenital fetal infection (e.g. toxoplasmosis, syphilis, HIV, rubella, CMV, HSV)
* irregular blood group antigens (subject or father of the baby)
* other condition amenable to noninvasive prenatal testing such as a single gene disorder (e.g., CF, sickle cell, Fragile X)

Exclusion Criteria:

* No fetal heart activity detected
* Mother or father have known chromosomal abnormalities (including known balanced translocations)
* Women with active or history of malignancy
The Effect of Diabetes Mellitus on Mortality of Patients With COVID-19

The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.

Retrospective records were examined by examining the electronic data files of the patients.

Polymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.

Patients over 18 years of age with and without a medical history of DM in their history were identified and compared in 2 groups.

The study includes patients over 18 years old who were hospitalized in our covid intensive care unit between March 16 and May 16, 2020.

Retrospective records will be examined by examining the electronic data files of the patients.

Polymerase Chain Reaction (PCR) tests performed with nasopharyngeal swab taken from the person, which is the standard diagnostic method, and also the diagnosis of infection symptoms, risk factors and thoracic CT scans indicating pneumonia were diagnosed.

Patients over 18 years of age with and without a medical history of DM in their history will be identified and compared in 2 groups.

Demographic data such as age, gender, Body Mass Index (BMI) of all patients, presence of additional comorbid disease, blood glucose values during hospitalization in intensive care, ferritin, C-Reactive Protein (CRP), respiratory support methods (nasal oxygen, nasal high flow, non-invasive mechanical ventilation, intubation), length of stay in intensive care unit, and mortality will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years of age

Exclusion Criteria:

* Patients under 18 years of age
Effects of Psycho-education of Patients With Bipolar Disorder

The purpose for this study is to determine whether psycho-education in groups is more effective than individual psycho-education for patients with bipolar disorder.

The main aim of the study is to compare the effects of psycho-education in groups with short individual psycho-education.

It is a randomized controlled trial including Bipolar 1 and 2 patients in a stable euthymic phase. 42 or 43 patients will receive group education in 10 weekly sessions and then a session every third month for two years. 42 or 43 patients will receive three individual sessions of education. Symptoms, admittances to hospital and function will be followed for two years.

Eligibility Criteria:
Inclusion Criteria:

* Bipolar Disorder 1 or 2 Euthymic

Exclusion Criteria:

* Active depression or mania/hypomania