cyrilzakka/clinical-trials huggingface dataset:
Single Pass Albumin Dialysis in Patients With Cirrhosis

The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

Albumin dialysis has beneficial effects in patients with acute on chronic liver failure. However, current devices are complex and costly. The aim of this study is to determine whether a simplified device of albumin dialysis also has beneficial effects.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Written consent after information of the patient or, in case of inability, by a parent or a close if he is present.
* Patient having a cirrhosis researched by previous exams (liver biopsy) or, in the absence of previous diagnosis, diagnosed in view of the results of clinical, biological and morphological data, whatever the origin of the cirrhosis (virus of hepatitis B, virus of hepatitis C, extreme consumption of alcohol or other reasons)

Exclusion Criteria:

* Participation to an other study in the 4 weeks before
* Active digestive bleeding, unchecked by the pharmacological treatments and the endoscopic techniques.
Reinforced Staple Line on Leak Rate in Distal Pancreatectomy

The investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm).

Pancreatic leak remains a significant cause of morbidity and extra cost following distal pancreatectomy. Historically, previous attempts to reduce the leak rate have met with limited success. To examine this problem the investigators propose a randomized, controlled trial of stapled pancreatic transection versus mesh reinforced stapled pancreatic transection. For the duration of the study period, participating surgeons will utilize a standardized staple technique. Either a reabsorbable polytrimethylene carbonate mesh (SEAMGUARD®) or reabsorbable strips of bovine pericardium (PERI-STRIPS DRY®) will be used to reinforce the stapled pancreatic transection line in the test group. In order to have a uniform test method, the investigators will utilize a laparoscopic stapling device for both open and laparoscopic procedures and a uniform staple size (4.8mm). A drain will be placed in the left upper quadrant at the time of resection. Drainage of the pancreatic resection bed is widely accepted and remains our current standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 years or older and able to give consent. Any patient undergoing a distal pancreatectomy, laparoscopic or open, will be eligible for randomization.
* No exclusion is provided for primary diagnosis. In the event of a patient undergoing a planned resection of another organ or organs with only a possibility of a distal pancreatic resection (i.e. colectomy, hepatectomy, gastrectomy, nephrectomy), the patient will still be eligible for inclusion in the study. We expect that some patients will be randomized but not resected (ie metastasis identified). A few patients may not be stapled using the study device for technical reasons (ie the stapler does not fit). The data will be analyzed in an intent-to-treatment approach.

Exclusion Criteria: None specified
Pharmacodynamics Aspects Of Porcine Heparin Sodium, Produced by Eurofarma, Compared Heparin Sodium, Produced by APP Pharmaceuticasls, in Patients With Chronic Renal Failure

1. Background: Heparin forms a complex with a plasma protein, antithrombin III (ATIII) is an endogenous anticoagulant. This complex inhibits the formation of thrombin and accelerates its destruction. In addition, heparin and ATIII inactivate other proteases of the coagulation cascade, especially the anti-activated factor X. The outcome of these biochemical actions is the inhibition of the formation and synthesis of activators of the clotting factors that exert critical functions in the genesis of the blood clot. Patients with chronic renal failure (CRF) that make use of hemodialysis need a system of anticoagulation with direct inhibitors of thrombin and / or heparinoids to prevent thrombosis.

   Based on clinical studies, the control of plasma heparin level in patients with CRF is essential. Coagulation tests such as APTT, PT, ChT and evidence of activity of anti-Xa factor to be used as a substrate for protection for those patients undergoing hemodialysis.
2. Objective: Check the non-inferiority clinical, the pharmacodynamic effect and safety in use of the drug heparin of porcine origin, produced by the Laboratory Eurofarma, having as the active comparator drug APP ® Heparin Sodium (heparin - APP Pharmaceuticals) in patients with renal failure who do hemodialysis treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adults of both sexes, regardless of color or social class;
* Age over 18 years, with good clinical doctor's discretion;
* Patients research that agree to participate in the study and sign the informed consent form (attached);
* Chronic renal failure patients in hemodialysis (3 times per week). chronic renal failure patients with indication for anticoagulation during dialysis

Exclusion Criteria:

* Non compliance with the terms described in the informed consent FICT;
* Patients suffering from sensitivity studies heparin sodium;
* Patients with hypersensitivity to search benzyl alcohol;
* Patients with search history of bleeding disorders or disease that a bleeding disorder can worsen or terminate the clinical picture, for example, frames of gastric ulcer;
* Patients with a history of research peptic ulcer;
* Patient with cancer research because of the possibility of impairment of variable coagulation function;
* Patients who are research during pregnancy and postpartum;
* Individuals with a genetic abnormality of the coagulation system;
* Trauma patients;
* Patients on glucocorticoid therapy for at least 1 month;
* Patients using other anticoagulants;
* Patients with a high rate of bleeding;
* Patients undergoing any surgery performed less than 15 days due to the risk of bruising at the site of surgery.
* Patients using drugs that affect hemostasis
* Patients using the following drugs: Salicylates systemic aspirin and other NSAIDs, including ketorolac, Dextran 40, ticlopidine and clopidogrel, systemic glucocorticoids, thrombolytic agents and anticoagulants and other antiplatelet agents, including antagonists of glycoprotein IIb / IIIa.
Feasibility of a Well-being Promotion Self-management Intervention in Post-COVID-19 Patients

A training comprised of positive psychological interventions set out to improve mental well-being was developed for post-COVID-19 patients. This study aims to evaluate the feasibility and acceptability of this training.

Research has shown that the quality of life and well-being of post-COVID-19 patients are often reduced, and that many patients struggle with self-management tasks, such as symptom management and emotion regulation. Training in self-management skills related to positive emotions, such as positive affect savouring, might help with these and can be provided prior to or in parallel with usual treatment. This study aims to investigate whether a training to improve the mental well-being is feasible and acceptable for people with post-COVID-19 syndrome. The training to be provided is based on previously evaluated sets of positive psychological interventions ('This is your life' and 'Training in Positivity') and adapted to a post-COVID-19 population. As a secondary aim, preliminary effectiveness will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Strongly suspected or clinically confirmed post-COVID-19 syndrome, i.e. confirmed symptoms persisting for at least 3 months after strongly suspected or confirmed SARS-CoV-2 infection
* Ages ≥18 years
* Dutch proficiency
* Provided informed consent

Exclusion Criteria:

* Recent (\<5 years) diagnosis of a mood disorder, anxiety disorder or other psychiatric condition
An in Vivo Comparison of the Debridement Efficiency of Needle Irrigation Versus Ultrasonic Irrigation

Study/Protocol Title: An in vivo comparison of the debridement efficacy of needle irrigation and ultrasonic root canal irrigation techniques

1. The purpose of this study is to compare the Vista ultrasonic bypass system and conventional needle irrigation to effectively clean the bottom third of the root canal during root canal therapy.
2. Participants will be recruited from the general patient pool of the OHSU School of Dentistry. Patients will have to qualify for the study by meeting the following criteria: age between 18 and 75 years old, ASA status I or II, are currently planning treatment for the extraction of teeth, and the patient understands and signs the consent form. The principal investigator will conduct an interview with the patient and the student-provider, and obtain informed consent from the patient.
3. The teeth to be extracted will be numbed with local anesthetic. The teeth will be isolated with a rubber dam and disinfected. The pulp chamber will be accessed using normal dental equipment and the root canal will be cleaned and shaped using either the ultrasonic irrigation technique or needle irrigation. This is the first step of standard root canal therapy. The tooth will then be extracted and the principal investigator will retain extracted teeth to perform further examination to see how thoroughly the root canals were cleaned. The teeth will be discarded after study.
4. Not applicable
5. The investigational device (Vista ultrasonic bypass system) consists of a 30 gauge slot needle which attaches to an ultrasonic unit (Satalec P5). Irrigants will be delivered to the apical 1/3 of the root canal through the needle at the same time the needle is being activated ultrasonically. Irrigant delivery will be controlled by a standard syringe pump. Conventional needle irrigation will be delivered using a 27guage slot needle placed into the root canal. Irrigants will be expressed with positive pressure at a location in the canal short of the needle binding
6. Once the first step of root canal therapy has been completed, the tooth will be extracted, decalcified, and tissue specimens will be taken from the bottom 3 mm. These sections will be evaluated under magnification and remaining debris in the root canal will be quantified using the NIH Image software. The data will be statistically analyzed to determine and differences between the two irrigation techniques.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1
* ASA 2
* Pts have current treatment plan at OHSU for extraction of some or all of remaining teeth and scheduled for delivery of a removable appliance post extraction
* Teeth used are able to be isolated with rubber dam
* Understand and sign consent form

Exclusion Criteria:

* ASA 3+
* No current treatment plan at OHSU
* Severely carious teeth resulting in inability to isolate for procedure
* Unable to understand or sign consent form
APHID- Primary Care Accuracy Study

We are studying patients' abilities to correctly identify the prescription medications they are taking. We are interested in understanding what tools will help patients correctly identify their medications. People participating in this study will be asked to either review a paper printout of their medication list or a computer program with their medications. The program will show the names and pictures of the medications. In either situation, participants will be asked to indicate if they are taking the medications as prescribed. We will then compare reported adherence between each medication review process. Participation may help the program developers improve the product.

The trial compares a paper-based medication adherence questionnaire to an electronic medication adherence questionnaire. Results from each arm will be compared to the ambulatory medication list on file with the clinic and a separate medication review interview conducted by a trained clinician. We intend to compare adherence patterns and medication use discrepancy rates between each approach. This data will help us to determine what strategies work best to solicit an accurate medication history from the patient.

Eligibility Criteria:
Inclusion Criteria:

* Veteran with Primary Care appointment at Portland VA
* Three or more medications in medication profile

Exclusion Criteria:

* Visual impairment
* Upper extremity neuromuscular impairment
* Cognitive impairment
* Unable to speak and read English
* Never been seen at a VA
A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

A Non-randomized, Open-Label Study to Evaluate the Safety and Effectiveness of Koya Dayspring Active Wearable Compression Technology for Treating Lower Extremity Lymphedema

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of age
* Willing to sign the informed consent and deemed capable of following the study protocol
* Subjects must have a diagnosis of primary or secondary unilateral lower extremity edema
* At the time of initial evaluation, individuals must be at least 3 months post surgery, chemotherapy and/or radiation treatment for cancer if applicable

Exclusion Criteria:

* Individuals with a history or presence of an acute systemic disorder or condition that could place the patient at increased risk from sequential compression therapy
* Inability or unwillingness to participate in all aspects of study protocol and/or inability to provide informed consent
* Patients with exam results that would prevent safe and effective use of the study device (cellulitis, open-wounds, healing-wounds, etc.)
* Patients must not have any diagnosed cognitive or physical impairment that would interfere with use of the device
* Diagnosis of lipedema
* Diagnosis of active or recurrent cancer (\< 3 months since completion of chemotherapy, radiation therapy or primary surgery for the cancer)
* Diagnosis of Acute infection (in the last four weeks)
* Diagnosis of acute thrombophlebitis (in last 6 months)
* Diagnosis of pulmonary embolism or deep vein thrombosis within the previous 6 months
* Diagnosis of pulmonary edema
* Diagnosis of congestive heart failure (uncontrolled)
* Diagnosis of chronic kidney disease with acute renal failure
* Diagnosis of epilepsy
* Patients with poorly controlled asthma
* Any condition where increased venous and lymphatic return is undesirable
* Women who are pregnant, planning a pregnancy or nursing at study entry
* Participation in any clinical trial of an investigational substance or device during the past 30 days
Study of NGR-hTNF as Single Agent in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma (HCC)

The main objective of the trial is to document the progression free survival (PFS) in advanced or metastatic hepatocellular carcinoma patients treated with NGR-hTNF as single agent.

Safety will be established by clinical and laboratory assessment according to NCI-CTC criteria

This is a phase II, open-label, non-randomized study that will be conducted in patients affected by advanced or metastatic Hepatocellular Carcinoma (HCC) previously treated with no more than one systemic therapeutic regimen, that will be conducted using Simon's two-stage design method.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years affected by advanced or metastatic HCC previously treated with no more than one systemic therapeutic regimen
* Histologically confirmed HCC not amenable to curative surgery
* Child-Pugh scale class A
* ECOG Performance status 0 - 1
* Patients in progression disease at study entry CT documented
* Adequate baseline bone marrow, hepatic and renal function, defined as follows:

  * Neutrophils \> 1.5 x 10\^9/L and platelets \> 100 x 10\^9/L
  * Bilirubin \< 2 x ULN
  * Transaminases \< 3 x ULN
* Absence of any conditions in which hypervolaemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (reference appendix "Technical data sheet human albumin")
* Normal cardiac function and absence of uncontrolled hypertension
* Patients must give written informed consent

Exclusion criteria:

* Decompensated cirrhosis (Child-Pugh score \>7)
* Concurrent anticancer therapy
* Patients may not receive any other investigational agents while on study
* Clinical signs of CNS involvement
* Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol
* Known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol
* Pregnancy or lactation. Patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration
POsitioning for Esophageal Cancer Resection

Open thoracoabdominal esophagectomy (TAE) is the standard curative treatment modality for resectable esophageal cancer. TAE can be achieved by positioning the patient in the supine position for the abdominal part and in a left-lateral decubitus (LLD) position for the thoracic part, or by performing both parts in a left-screwed supine position (LSS). Aim of the present study is to compare peri- and postoperative outcome variables after TAE for esophageal cancer in the two positions.

POETRI is designed as a single-center, randomized controlled trial with two parallel arms including patients with resectable esophageal cancer and type I cancers of the esophagogastric junction (AEG I). Exclusion criteria are inability to tolerate surgery or both types of positioning, inability to perform an intrathoracic anastomosis, non-malignant pathologies. The primary endpoint is operating time. Secondary endpoints are morbidity, lymph node yield, pulmonary function, pain control and wound healing assessed during a follow-up of 3 months.

POETRI is a single-center, randomized controlled trial to evaluate different positioning and thoracic access during radical open thoracoabdominal esophagectomy for patients with resectable esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, non-metastatic esophagus cancer (squamous or adenocarcinoma) or AEG I tumors requiring curative thoracoabdominal esophagectomy with intrathoracic anastomosis of a gastric tube immediately after diagnosis or after neoadjuvant treatment
* Patients are considered fit for surgery by a local interdisciplinary team of surgeons, medical oncologists and anesthesiologists (ECOG performance status of 0,1, or 2).
* Age ≥ 18 years
* Written informed consent

Exclusion Criteria:

* Preoperative established indication for colon interposition or cervical anastomosis
* Preoperative diagnosed tracheo-esophageal fistula
* History of right thoracotomy or prior lung surgery
* Physical inability of the described intraoperative patient positioning
* Non-malignant esophageal pathology or other malignancies except squamous or adenocarcinoma
* Planned laparoscopic or thoracoscopic surgical approach
* Patients not eligible for TAE (ASA ≥ 4)
Registry of Patient With M. Dupuytren and Validation of the Brief MHQ

The purpose of this study is the validation of the Brief Michigan Hand Questionnaire by patient with Morbus Dupuytren and to build up a register.

examination of the characteristics of Patient with Morbus Dupuytren and the psychometric properties of the Brief Michigan Hand Questionnaire by this patients

Eligibility Criteria:
Inclusion Criteria:

* M.Dupuytren, over 18y, able to speak and understand german

Exclusion Criteria:

* recurrence, pregnancy, incapable of contracting
Study of the Use of Hearing Protection Equipment in the Occurence of Acute Acoustic Trauma in the Army

Each year, military epidemiological surveillance counts approximately 1,000 acute acoustic injuries. Most are caused by exposure to weapon noise during training sessions while military personnel are provided with hearing protection. Several hypotheses could explain the occurrence of acute acoustic trauma despite wearing protections:

* A lack of practices or knowledge about the use of hearing protection equipment that could facilitate the occurrence of acute acoustic trauma (improper fitting, use of an inappropriate type of protection, dropping of protectors, inappropriate removal)
* A failure to seal the external ear canal due to an inappropriate plug size. These hypotheses will be explored using a questionnaire distributed to a population of Army soldiers training to shoot.

The main objective is to determine the predictive factors corresponding to practices or knowledge related to the use of hearing protection equipment in the occurrence of acute acoustic trauma in a population of Army soldiers.


Eligibility Criteria:
Inclusion Criteria:

* Be a member of the Army
* Having performed at least one shooting session in the last 12 months

Exclusion Criteria:

* Inability to read and/or write in French language
Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens

The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study medication is given.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 12 - 35 years
* Severe hemophilia A ( \< 1 % FVIII:C)
* No history of Factor VIII inhibitory antibody
* For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present.
* Complete documentation of joints bleeds and their locations prior to start of prophylaxis,
* Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.
* For the on-demand subjects \> 12 bleeds/year in the last 5 years.
* Written informed consent by subject and parent/legal representative, if \< 18 years

Exclusion Criteria:

* Individuals with other coagulopathies (e.g., von Willebrand disease)
* HIV seropositive subjects
* Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee)
* HCV seropositive individuals who underwent interferon therapy during the last 12 months
* Individuals for whom high-magnetic exposure is contraindicated (see section 7.1)
* Synovectomy performed within the six months prior to investigation enrollment or orthopedic surgery planned to be performed within the investigation period
* Joint replacement
* For the on-demand treatment group, any period greater than 8 consecutive months having received \>/= 50 IU per kg per week Factor VIII for the prevention of bleeding