cyrilzakka/clinical-trials huggingface dataset:
The Longitudinal PTH-Study

The main study aim is to quantify the agreement between the analytical results provided by two third generation and two second generation Parathyroid hormone (PTH) assays. The primary comparison will be performed between the second-generation PTH assay"Intact PTH assay" from Siemens Healthcare Diagnostics Inc. and the third-generation PTH assay "biointact (1-84)" from Roche Diagnostics in terms of a Bland-Altman analysis. Several studies have evaluated the correlation between various PTH assays at a single time-point, but no previous study has tested the hypothesis that longitudinal changes in PTH levels, which are important for making treatment decisions, can be monitored by several PTH assays alike. To this aim, the key secondary objective is to analyze the longitudinal variance in PTH over the course of 1 year, using each of two assays of the second and third generations, respectively. Other secondary objectives include determining changes in serum phosphate, serum calcium, fibroblast growth factor 23 (FGF23), with respect to treatment decisions. For clinical applicability of the results to be obtained here, an important goal of the present study will be not to influence treatment decisions, which will remain independent of the study investigators, at the full responsibility of the hemodialysis physicians.

At every quarterly blood draw over the course of one year, the investigators will freeze the serum from 100 patients, and at the end of 4 quarters the investigators will analyze PTH-levels using the following assays: Intact Parathyroid Hormone (Advia Centaur, Siemens Healthcare), PTH-Intact (Cobas, Roche), PTH (1-84) - The agreement between the PTH assays will be analyzed at baseline, as well as at the subsequent quarterly evaluation time-points by Bland-Altman analysis and complemented by Passing-Bablok regression. The longitudinal changes in PTH will be displayed graphically and analyzed by estimating the within-patient variance across time, the between patient variance at each time-point as well as effects on the mean log-PTH level due to course of disease and therapeutic interventions from a linear mixed model.


Eligibility Criteria:
Inclusion Criteria:

* All patients who were undergoing uninterrupted hemodialysis or hemodiafiltration at the Chronic Hemodialysis Unit of the Division of Nephrology and Dialysis, Medical University of Vienna between November 1st, 2017 and December 31st, 2018.
* Existence of residual blood samples from four successive quarterly routine controls
* Age ≥ 18 years
* The test result of the assay must not have any diagnostic value or therapeutic consequence for the patients included in this study.

Exclusion Criteria:

* Death during the observational period (all patients must have lived through the 1-year period and must have all 4 quarterly blood draws performed on them).
* Age \<18 years
Thrombolytic Therapy Versus Surgery for Obstructive Prosthetic Valve Thrombosis

Prosthetic heart valve thrombosis is a serious complication with high mortality and morbidity The best treatment of PVT is controversial, although surgery and thrombolysis options have been available. In this randomized and multicenter study, the investigators compared thrombolytic therapy versus surgery for the treatment of patients with obstructive prosthetic valve thrombosis.

Two different randomization group have been defined and patients with obstructive prosthetic valve thrombosis are included in each group randomly. In the first arm, thrombolytic therapy (TT) is performed to the patients with obstructive prosthetic valve thrombosis. The TT regimen depends on the functional status of the patient. In patients with NYHA class III-IV dyspnea low dose, relatively faster TT regimen (25 mg tPA/6 hours) is performed. In patients with NYHA class I-II dyspnea TT with low dose and ultra slow infusion of tPA (25 mg tPA/25 hours) is performed. During TT, patients are followed up with transesophageal echocardiography in every 24 hours. In the second arm, redo valve surgery is performed for obstructive valve thrombosis. This multicenter study is conducted in Cardiology and Cardiovascular Surgery Departments of Kosuyolu Kartal Heart Training and Research Hospital, Istanbul, Turkey, Siyami Ersek Heart Training and Research Hospital, Istanbul, Turkey, Ankara Heart Training and Research Hospital, Ankara, Turkey, İzmir Atatürk Heart Training and Research Hospital, İzmir, Turkey, Erzurum Atatürk University Faculty of Medicine, Erzurum, Turkey, Diyarbakır Dicle University Faculty of Medicine, Diyarbakır, Turkey and Kars Kafkas University Faculty of Medicine, Kars, Turkey. Informed consent is taken from all patients.

Eligibility Criteria:
Inclusion Criteria:

* Obstructive prosthetic valve thrombosis

Exclusion Criteria:

* Non-obstructive prosthetic valve thrombosis
Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA)

Multicentric, national, prospective, parallel group, controlled. The Subjects in every center will be randomized and assigned to the pharmacologic arm or the one with the biochemical monitoring


Eligibility Criteria:
Inclusion Criteria:

Only subjects who meet all of the following criteria will be eligible to participate in this study:

* Male patients
* Age ≥ 45 years
* Suspected presence of prostate inflammatory foci, defined according to the following criteria:
* PSA ≥ 2.6 ng/mL and age ≥ 50 and \< 60 years (or ≥ 45 years if the patient has known family predisposition to carcinoma of the prostate) or,
* PSA ≥ 4.1 ng/mL and age ≥ 60 and \< 75 years, and
* normal digito-rectal examination (DRE) (see section 5.2), and normal urine test with dipstick and/or microscopy carried out within 5 days of the baseline visit
* Patients willing and able to provide their written informed consent and to comply with study procedures.

  * Patients with LUTS/BPH on watchful waiting or already under treatment with alpha-blockers or 5-ARI (5-alpha reductase inhibitors) for at least 6 months will also be considered eligible to participate in the study.

Exclusion Criteria:

Patients who meet any of the following criteria will not be eligible to participate in this study:

* Diagnosis of NIH class I-III prostatitis or clinical evidence of active acute urinary infection and/or known or suspected active bacterial infection at other sites;
* Diagnosis of prostate carcinoma (or PIN or ASAPS) or prior radical prostatectomy or radiotherapy or other treatments for prostate cancer;
* PSA \> 20 ng/mL;
* PSA values (including high values) stable over time;
* Start of a pharmacological therapy with 5-ARI in subjects with LUTS/BPH;
* Permanent catheter;
* Prior treatment (within 4 weeks) with levofloxacin for genital-urinary infections;
* Known or suspected allergy to levofloxacin, including the excipients contained in the pharmacological preparation and/or confirmed tendency to photosensitivity reactions after fluoroquinolone therapy;
* Concomitant treatment with drugs not allowed in the study
* Reluctance to undergo prostate biopsy and/or risk of non-compliance;
* History or current evidence of alcohol or drug abuse in the last 12 months;
* History of any conditions that, in the opinion of the investigator, may confound the study results or create additional risks for the patient.
* Participation in any study of investigational or marketed drugs within 30 days before the baseline visit or during the study.
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects

A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.

An open label study to assess the pharmcokinetics, safety and tolerability of a single dose of Selumetinib (AZD6244, ARRY-142886) in patients with hepatic impairment and healthy subjects.

Eligibility Criteria:
Inclusion Criteria for all participants:

1. Subjects will be males or females (non-childbearing potential) aged 18 years or more and with a weight of at least 45 kg and a BMI between 18 and 40 kg/m2 inclusive.

   Inclusion Critera only for hepatic impaired patients:
2. Subjects with stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study.

   Inclusion Criteria only for healthy volunteers:
3. Subjects must be in good health, as determined by a medical history, physical examination, 12-lead ECG, clinical laboratory evaluations, and an ophthalmic examination performed before the administration of the investigational product.

Exclusion Criteria for all participants:

1. Subjects of Japanese or non-Japanese Asian ethnicity
2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian (eg, China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian Indians are acceptable.
3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the investigational product
4. Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day.

   Exclusion criteria for hepatic impaired patients only
5. Undergone liver transplantation. -
Identification Of Occupational Exposures In Patients With ILD

Diffuse interstitial lung disease brings together a heterogeneous group of pulmonary pathologies, characterized by infiltrating and diffuse lesions of the pulmonary interstitium. The evolving risk of these ILD is pulmonary fibrosis, with the development of chronic respiratory failure.

The process of the etiological diagnosis of ILD results from a multidisciplinary approach (pulmonologists, radiologists, occupational health specialists, anatomo-pathologists, etc...). Indeed, the multitude of possible causes of these diseases makes the etiological diagnosis difficult. Professional aetiologies are also frequently mentioned : pneumoconiosis, hypersensitivity pneumonitis, as a differential diagnosis.

It therefore appears essential to deepen the professional aspect during the diagnostic process for ILD.

Since May 2020, a professional interview has been systematically offered by the Occupational Pathology Consultation Center of the Hospital Center Lyon Sud, to patients followed by the team of Professor Vincent COTTIN, whose file was discussed in a multidisciplinary meeting.

The data collected to constitute a database are the following variables: age, sex, diploma, professional course coded in CITP (International Standard Classification of Professions) and NAF (French Nomenclature of Activities), occupational exposures, smoking, risk factors non-professionals, clinical elements of ILD and elements relating to an occupational disease certificate. This database is anonymized.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ILD.
* File discussed in a multidisciplinary meeting since May 2020 at the Louis Pradel Pneumological Hospital.
* Have benefited from a professional interview in the Occupational pathology consultation center of the Hospital Center Lyon Sud.

Exclusion Criteria:

* Patients with sarcoidosis.
Effects of Online Cognitive Control Training on Rumination and Depressive Symptoms

The present study examines whether a computerized cognitive control training as compared to a placebo (fake) training will reduce the frequency of depressive rumination in depressed individuals. Rumination has been identified as a major risk factor for the onset and recurrence of depressive episodes and it has been suggested that it is linked to deficits in cognitive control functions. It is thus expected that training cognitive control will reduce the frequency of rumination as well as ameliorate its detrimental effect on negative mood states.

Rumination has been shown to intensify dysphoric mood and is one of the best researched risk factors for the onset and recurrence of depressive episodes. Accumulating evidence suggests that the tendency to ruminate is linked to impairments in cognitive control functions, especially to problems discarding no longer relevant negative material from working memory (=working memory updating).

The aim of the present study is to examine whether training to update emotional material in working memory will have an effect on the frequency of using rumination as well as on the impact of rumination on mood in the daily lives of clinically depressed participants. Participants will be randomly assigned to 10 sessions of either online cognitive control training or an online placebo condition. The ability to update emotional material in working memory will be assessed pre and post training by two computer tasks (close and far transfer tasks). The effects of the training on daily rumination and the dynamics between daily mood and rumination will be assessed pre- and post-training, as well as at 3-months follow-up using ambulatory assessment (via smartphone app). It is expected that individuals in the training as compared to the placebo group will show a greater reduction in rumination frequency as well as a reduction in the negative impact of rumination on mood.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) criteria for a current major depressive episode
* 18-65 years of age
* German native language (due to verbal task requirements)

Exclusion Criteria:

* life time diagnosis of any bipolar or psychotic disorder, or substance dependence
* substance use disorder within past 12 months
* current obsessive-compulsive disorder (OCD) or borderline personality disorder (BPS)
* reporting severe underweight (BMI\<18), any neurological disease, severe head injury (e.g. severe concussion), or any brain damage (e.g. due to stroke)
* concurrent psychotherapy during the duration of the study
Parathyroid Auto-transplantation: Prospective Randomized Trial of the Personalized Site

The functional parathyroid auto-transplantation (PA) could release parathyroid hormone (PTH) into the circulatory system of the body through the capillaries. But when parathyroid glands were auto-grafted in the sternocleidomastoid muscle, it would be inconvenient to detect PTH to examine whether the graft functions. So the investigators took the forearm as the aim place for auto-transplantation, either subcutaneous or brachioradialis, with its relatively fixed - antecubital vein blood test which is simple. The survival criteria is assumed as the PTH gradient of 1.5 times or greater through comparing the bilateral PTH value in grafted and not-grafted forearm.


Eligibility Criteria:
Inclusion Criteria:

* patients with indications for PA treatment during cervical surgery

Exclusion Criteria:

* patients suffering secondary hypoparathyroidism with forearm fistulization
Clinical Validation of Algorithms for Mean Systemic Filling Pressure and Automated Cardiac Output

Prospective combined clinical validation of an algorithmic calculated mean systemic filling pressure (Pms-Nav) with the gold standard for Pms (Pms calculated from venous return curves during inspiratory hold procedures with incremental airway pressures; Pms-Insp). Secondary correlation between invasive cardiac output measurement versus 3D TOE and carotid echo doppler measured cardiac output.

Background of the study:

Volume-state in critically ill patients is a difficult parameter to determine, and knowledge about it could make the difference between life or death concerning proper treatment. Determination of volume state starts with adequate 3D transesophageal echocardiography (TOE) in the operation room, including with non-invasive doppler carotid artery measures. TOE is a standardly used method in cardiac surgery. Because echocardiography only gives information about volume status at a certain timepoint, a real-time continuous value reflecting volume-status is needed. "Mean systemic filling pressure (Pms)" appears to be a promising value reflecting volume status. There is a reliable, but cumbersome method available which to date serves as a gold standard to determine Pms (Pms calculated by constructing venous return curves during incremental levels of airway pressure, thereby simulating a decrease in preload --\> Pms-Insp). However, this method cannot be used in daily clinical practice because it is laborious and cumbersome. Therefore there is a need for a non-invasive methods measuring Pms, which could now be determined by a computerized algorithm with the Navigator-device (Pms-Nav). It is key to compare this Pms-Nav with its gold standard (Pms-Insp) in order to establish a clinical validation for Pms-Nav.

Objective of the study:

1. Is there a good correlation between Pms-Nav and Pms-Insp?
2. Is there a good correlation between invasive continuous cardiac output measurement (by thermodilution and pulse-contour analyse detected by the PiCCO-device) and 3D transoesophageal echocardiography (TOE) and carotid echo doppler?

Eligibility Criteria:
Inclusion Criteria:

* Good left and right ventricular ejection fraction
* No significant valvular insufficiencies/stenoses
* No significant comorbidity
* Signed informed consent
* Elective coronary artery bypass surgery
* Postoperative mechanically ventilated admitted to the PACU

Exclusion Criteria:

* Withdrawal informed consent
* History of pneumonectomy of lobectomy
* Mechanical support of circulation
* COPD Gold 3 or 4
* Complications during surgery
* Postoperative bleeding \>50mL/15 minutes after admission to PACU - No thoracic drain in pleura
* Postoperative pneumothorax
* Participation in other research studies/trials
* Elevated intra-abdominal surgery (\>12 mmHg)
ARTEMIS Synovial Markers in Arthritis Childhood

The aim of this study is to find markers that could differentiate infectious and inflammatory arthritis. The investigators want to find markers by differential analysis by compare synovial fluids of septic and inflammatory arthritis. The investigators will use for this analysis, proteomics, cytokine dosage and monocyte typing by flow cytometry analysis. The investigators will use one marker or a score with biological and clinical data to discriminate arthritis of infectious and inflammatory etiology.


Eligibility Criteria:
Inclusion Criteria:

* Septic arthritis with bacteriological identification
* Juvenile idiopathic arthritis beyond the ILAR definition
* Having acute arthritis requiring an articular draining
* Child benefiting from a national insurance scheme
* Collection of the consent of the parents or the legal representative

Exclusion Criteria:

* Contraindication in an articular draining: platelet 50 000 / mm3, Rate of prothrombins lower than 70 %, activated partial thromboplastin times (APTT)\> 1,5
* Treatment by biotherapy, corticoids or other immuno suppressor in the month preceding the articular draining.
* Treatment by antibiotic begun more than 24 hours before the draining.
Food and Gastrointestinal Habits After Bariatric Surgery

The worldwide epidemic of overweight and obesity affects about 1.7 billion people around the world. Since 1991, many international medical societies have established as recommendation for bariatric surgery the unsuccessful clinical treatment in patients with IMC \> 40Kg/m2 or IMC \> 35Kg/m2 in the cases with serious co-morbidities related to the possible reversion of them with the lose of weight due to the surgery. In front of the new anatomical condition from the gastrointestinal tract the patients present changes in food preferences and in the food intake, which include modifications in food choices, perception of hungry and satiety and in the tolerance to determinate food. These changes in food intake of the patients are observed mostly in the first year after the surgery an adaptive phase to a new condition.

After the new anatomical condition of the gastrointestinal tract, provided by bariatric surgery leads patients to experience changes in food intake and behavior. The aim of this study was to assess alimentary habits, food intolerances and gastrointestinal symptoms in patients who underwent bariatric and metabolic procedures: Roux-en-Y gastric bypass, biliopancreatic diversion and duodenal exclusion. We studied 34 patients of both sexes, from outpatient clinics in Surgery of Obesity and the Metabolic Surgery at University of Campinas. They were submitted to bypass gastric in Roux-en-Y (n=15), biliopancreatic diversion (n=9) and duodenal exclusion (n=10). Validated questionnaire for assessment of food tolerance was applied in patients with more than six months of follow-up after surgery addressing diet and gastrointestinal symptoms. The descriptive and comparative analyses were performed by analysis of variance and bivariate correlation. In patients who underwent to bypass gastric food intolerance was greats regarding to ingestion of rice (33%) and red meat (33%) in comparison to others groups. The flatulence and diarrhea were more prevalent in patients who underwent biliopancreatic diversion. The vomiting was more prevalent in patients who underwent gastric bypass. Each procedure presents peculiarities to the anatomical and functional changes that affect the food absorption. This may have negative effects on the nutritional status of patients and affect the quality of life. The nutritional therapy for each individual procedure may assist in the management of clinical concerns of operated patients

Eligibility Criteria:
Inclusion Criteria:

* Patients submitted of bypass gastric, biliopancreatic diversion and duodenal exclusion

Exclusion Criteria:

* Presenting no diseases that could compromise their nutritional status, such as liver disease, kidney or cancer.