cyrilzakka/clinical-trials huggingface dataset:
GORE-TEX PROPATEN Vascular Graft Study

To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.


Eligibility Criteria:
Inclusion Criteria:

* Patient requires primary above-knee bypass where the proximal anastomosis will be to the common femoral or proximal superficial femoral artery and the distal anastomosis will be the popliteal artery proximal to the medial head of the gastrocnemius;
* Patient has Grade III or IV occlusive vascular disease;
* Patient has a postoperative life expectancy greater than one year;
* Patient is at least 21 years of age;
* Patient is able to comply with all study requirements and be available for follow-up visits at 1 month, 6 months and 12 months post procedure;
* Patient is willing and able to provide written, informed consent.

Exclusion Criteria:

* Patient had a previous bypass in the diseased extremity (below iliacs);
* Patient has known coagulation disorders including hypercoagulability;
* Patient has had any previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin;
* Patient has an acute embolic arterial occlusion;
* Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts;
* Patient had percutaneous transluminal angioplasty to the implant site within the previous 30 days;
* Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure;
* Patient has active infection in the region of graft placement; or
* Patient has an incomplete preoperative assessment (as outlined in this protocol) due to an emergency procedure, a traumatic injury or any other reason.
Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)

The investigators performed this study to investigate pain prevention of preoperative topical nonsteroidal anti-inflammatory drug (NSAID) in photorefractive keratectomy(PRK) using time serial pain scoring.


Eligibility Criteria:
Inclusion Criteria:

1. at least 19 years of age
2. simultaneous bilateral PRK schedule
3. more than 400μm(including epithelium) of postoperative corneal thickness
4. less than 150μm of ablation depth.

Exclusion Criteria:

1. a history of ocular surgery or trauma
2. two-diopter more difference in spherical equivalent (SE) between the eyes, 3. keratoconus or other corneal pathology

4. use of systemic or topical NSAID within 1 month before the surgery 5. history of allergic reaction to aspirin or other NSAIDs 6. glaucoma or ocular hypertension (\> 20 mmHg) 7. collagen vascular diseases 8. diabetic retinopathy 9. pregnancy or lactation 10. intraoperative complications.
Acute Immunological Effects of Exercise in Cancer Patients

The aim of the study is to evaluate and compare immune response to a single exercise intervention in cancer patients and healthy age-maged individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents and young adults \>14 years of age
* undergoing acute cancer treatment (chemotherapy)
* signed informed consent

Exclusion Criteria:

* Inability to follow and implement test instructions
* medical contraindication to HIIT on cycle ergometer
* chemotherapeutic treatment 48 h prior
* Hb \<8g/dl; platelets \< 20,000/ul.
Severe Septic Shock Complications

Adults older than 18 years old, admitted to the ICU with a Severe Septic Shock, requiring Norepinephrine at more than 0.25mcg/kg/min, who have signed informed consent form, will be consecutively included, from december 2018 to december 2019.

The primary goal is to look for risk factors associated with an increased in lactate clearance

Secondary goals are the following:

1. To look for risk factors associated with an increase risk of Hospital and ICU length of stay.
2. To look for risk factors associated with an increase risk of Acute Kidney Injury.
3. To look for risk factors associated with a decrease in days alive and free of Mechanical Ventilation, Vasopressors and Renal Replacement Therapy.
4. To look for risk factors associated with a decrease in Ventilator-free days.
5. To look for risk factors associated with a decrease in Vasopressor-free days.
6. To look for risk factors associated with an increase risk of in-hospital mortality.
7. To look for risk factors associated with an increase risk of Myocardial Infarction and myocardial injury.
8. To look for risk factors associated with an increase risk of Acute Respiratory Distress Syndrome.
9. To compare and validate different risk scores in our cohort.


Eligibility Criteria:
Inclusion Criteria:

* Adults older than 18 years old admitted to ICU with Severe Septic Shock

Exclusion Criteria:

* Rejecting participation by not signing informed consent form.
Interactive Computer-adaptive Chronic Kidney Disease Education Program

The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC

The goal of this pilot clinical trial is to evaluate a culturally tailored adaptive computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The investigator's first hypothesis is that computerized adaptive education (CAE) will be more effective than standard of care in improving knowledge about self-care for advanced CKD and renal replacement therapy (RRT) options (Primary Outcome). The primary outcome is knowledge about CKD and knowledge about RRT. The study team will measure this using the Kidney Disease Knowledge Survey (KiKs). The investigator's second hypothesis is that CAE will increase patients' intent to participate in CKD self-care (to take diabetes and/or hypertension meds, see a nephrologist, and make additional lifestyle changes like smoking cessation, exercise, low-salt diet) compared to standard of care. The study team will measure this using an investigator-developed Health Intent Survey and measure patient activation through the Patient Activation Measure (PAM). Similarly, the investigator hypothesizes that CAE will increase patients' intent to obtain non-catheter access prior to dialysis initiation, to initiate self-care dialysis (peritoneal (PD) or home hemodialysis (HHD), and/or have transplant evaluation compared to standard of care. The study team will measure this using an investigator-developed Health Intent Survey. The investigator's final hypothesis is that CAE will increase patients' action at 30 days post-discharge in participating in CKD self-care and CKD health-seeking behavior compared to standard of care controls.

Eligibility Criteria:
Inclusion Criteria:

* African-American inpatients
* Ages 18-70
* estimated glomerular filtration rate (eGFR)\<45
* Enrolled in the Hospitalist Project

Exclusion Criteria:

* Does not self-identify as African American
* Not able to consent
* Unable to speak English
* eGFR \<45 due to acute kidney injury
* In Intensive Care Unit
* has had a transplant
* currently on dialysis
Viusid in Adults With Acute Fever of Viral Etiology

The purpose of the study is to assess the safety and effect of Viusid (bags of 4 grams) administration in the treatment of acute fever of viral etiology as diagnosed by clinical, hematologic and serologic parameters. The duration of this open and randomized phase 2 clinical trial will be 6 days. The estimated number of persons with acute fever of viral etiology to be recruited and randomized for the study is 200. The primary outcome measure: platelet, leukocyte and granulocyte count will be assessed at the beginning and the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Acute fever of viral etiology with less than 72 hours of progression
* Signed informed consent.

Exclusion Criteria:

* Patients under treatment with other antioxidants.
* Inability to swallow the content of Viusid bags
Lactoferrin Versus Iron Supplement in Irondeficiency Anemia and Weight Loss in Obese Children

The effect of lactoferrin versus iron supplement in treating iron deficiency anemia and helping weight loss in obese school age children

Comparing iron versus lactoferrin as regard iron defiency anemia and weight loss in obese children

Eligibility Criteria:
Inclusion Criteria:

* 1. children age will be between 6 -12 years old. 2. Presence of iron deficiency anemia, it will be diagnosed by

  * CBC \>\> Hemoglobin level concentration below 11.5 g/dl.
  * level of serum iron is below 30 µmol/l,
  * level of ferritin is below 15 µg/dl
  * Total iron binding capacity is more 480 µg/dlL. 3. children should be stable and free from chronic disease. 4. Body Mass index (BMI) should be ≥the 95th percentile for children and teens of the same age and sex.

    5. there is not history of iron supplements in the 3 months before treatment.

Exclusion Criteria:

1. Father/mother refuses to participate in the study.
2. Hospitalized patient.
3. Non-anemic patient.
4. Patients receiving iron supplements 3 months before enrollment.
5. Patients with chronic diseases.
6. personal or family history of allergy to cow's milk or infant formula, eczema, moderate-to-severe allergic rhinitis or asthma, or milk intolerance.
7. severe anemia as Hemoglobin level concentration below 7 g/dl.

Exclusion Criteria:

-
A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin


Eligibility Criteria:
Inclusion Criteria:

* Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
* Male or Female at least 18 years of age
* Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
* Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
* Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

Exclusion Criteria

* Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
* Active known or suspected autoimmune disease
* Any serious or uncontrolled medical disorder or active infection
* Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus

Other protocol defined inclusion/exclusion criteria apply
Post Intensive Care Syndrome

Barthel Index and demographic variables of patients were collected to investigate the question whether the improvements of the functionality improves the Barthel Index over the years.

idem

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* length of stay longer than 48 hours

Exclusion Criteria:

* no exclusion criteria if inclusion is correct
Rectrospect - a Retrospective Study of Treatment Response

Biopisies from patients diagnosed with rectal cancer between 2007-2019 will be cut into 4-6 micrometer thin sections for morphology and immunostaining. Every section will be numbered with a code that is connected to the patients personal identification number and the code list will be kept separately from the biopsies in a password protected file on the Sahlgrenska University Hospital server.

Patient data and outcome regarding response to treatment will be collected from patient charts and the Swedish ColoRectal Cancer Registry, but all data will be numbered with the same code number and all results will be kept away from the code list. In order to achieve the stated aims, that is, to study how the molecular and cellular characteristics of the tumour and its surrounding microenvironment as well as the interaction of tumour cells and immune cells affect treatment response, several molecular and cellular techniques and assays may be applied.


Eligibility Criteria:
Inclusion Criteria:

* Rectal cancer and treatment between 2007 and 2019

Exclusion Criteria:

* No rectal cancer or no neoadjuvant treatment
The Effect of Web-Based Training and Counseling Given to Caregivers on the Pressure Injury Risk, Level of Dependence-Independence, and Caregivers' Burden of Care in Bedridden Patients

Education and counseling of patients and caregivers, either face-to-face or using various communication technologies, are reported to have significant effects. Nurses are in a key position in the education and counseling of patients and their relatives for the prevention of pressure injury. Although the share of health technologies in the management of pressure injury is important, it is also important for nurses to use these technologies. Web-based education, which is a part of health technologies, is defined as an education and training program created by using the features of internet and computer technologies.

To prevent pressure injuries; It has been determined that there are a limited number of studies in which training, telephone monitoring and counseling are provided to caregivers The originality of this study, which was conducted to evaluate the effect of web-based training given to caregivers on the pressure injury development of bedridden patients, addiction independence level and care burden of caregivers; The training is designed as web-based and creates a guide that caregivers can use during the care process.

Eligibility Criteria:
Inclusion Criteria:

The patient;

* Being over 18 years of age
* Being open to communication (Mini Mental Test Score \&amp;gt;25 points),
* Medium or high risk according to the Braden pressure injury assessment scale (score ≤14 according to the Braden pressure injury risk assessment scale)
* Being at least a moderately dependent patient according to the Barthel Index (score ≤90 according to the Barthel Index) The caregiver;
* Being primarily responsible for patient care,
* Being over 18 years of age
* Having a family bond with the patient,
* No monthly fee for providing care, (except for those receiving a monthly care pension from the state)
* Lack of healthcare workers (physician, midwife, nurse),
* Ability to read and write,
* Having a smartphone and internet access,
* Accepting a home visit,
* There is no physical or psychiatric obstacle that prevents communication,

Exclusion Criteria:

The patient;

* Having cancer,
* Having an active skin disease,
* Blood glucose and blood pressure are not under control,
* Use of medication that may be associated with pressure injury (corticosteroid, immunosuppressive, sedative medication, antineoplastic medication, norepinephrine) is an exclusion criterion from the study.

Criteria for Exclusion from the Study The patient;

* The patient is hospitalized,
* The patient\&amp;#39;s exitus is a criterion for exclusion from the study.
Control Trial of Intermittent Hemodialysis With Regional Citrate VS Priming Heparin With Predilution in Patients at Risk of Bleeding

The study investigators hypothesize that intermittent hemodialysis with regional citrate anticoagulation (Prometheus system/Frésénius) is more efficient than reduced systemic heparin anticoagulation in patients at bleeding risk hospitalized in nephrology intensive care unit


Eligibility Criteria:
Inclusion Criteria:

* The patient has been correctly informed.
* The patient must have given his/her informed and signed consent.
* The legal guardian or trusted-person of an adult under guardianship must have given their informed and signed consent.
* The patient has health insurance coverage via the French social security system.
* The patient is at least 18 years old.
* The patient is at bleeding risk; the bleeding risk is defined by the clinical situation and according to predefined clinical situations (before or after surgery or biopsy, hemorrhage).
* The patient requires an intermittent hemodialysis in a nephrology ICU setting.

Exclusion Criteria:

* The patient is participating in, or has participated in over the past three months, another interventional trial.
* The patient is in an exclusion period determined by a previous study.
* The patient is under judicial protection.
* The parents (or legal guardian) of the patient refuse to sign the consent.
* It is impossible to correctly inform the patient/parents (or legal guardian) of the patient (language barrier).
* Contraindication to heparin treatment.
* Indication of continuous dialysis in ICU.
* Pregnancy.
Life-long Tele-monitoring of Patients With Type 2 Diabetes Mellitus in Central Greece

To evaluate whether patients with type 2 diabetes mellitus can be followed by simplified, centralized and large scale tele-monitoring of blood glucose levels and blood pressure, and whether this intervention produces health and economic benefits when introduced without major changes to the existing organization of a large tertiary care center.

The present study aims to examine the clinical and financial effects and the patients' perception and satisfaction of home telemedicine support system for diabetes management versus standard (usual) care. In the intervention group the patients will be provided with a blood glucose meter and a mobile phone and their data will be transferred via the mobile to the regional database and will be assessed by the allocated care team. Appropriate counseling on treatment and symptoms or problems related to diabetes will also be provided.

Measurements of HbA1c will be taken to assess glycaemic control while the dietary and the exercise habits will be assessed by the use of questionnaires. In addition the patients' satisfaction from the use of the telemedicine service will be studied. A Cost-Effective Analysis and Cost Utility Analysis will be applied to evaluate the tele-health service compared with the usual care from the health and social perspective. The effect of the tele-health service in the organization structure of the outpatient hospital department will be evaluated with a qualitative study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 Diabetes
* HbA1c \> 53 mmol/mol (7.0 % according to NGSP)
* Capability to use the devices provided
* Being cognitively able to participate
* Capability of filling in questionnaires in german or greek language
* Absence of severe comorbidity prevalent on diabetes with life expectancy \< 12 months

Exclusion Criteria:

* Pregnancy
Autologous Cell Therapy for Female Stress Urinary Incontinence

The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.


Eligibility Criteria:
Inclusion Criteria:

* SUI with normal detrusor activity confirmed with urodynamics
* Bladder capacity \>200 ml
* Incontinence has not shown any improvement for at least -6 months
* Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)

Exclusion Criteria:

* Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
* Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
* Uncontrolled diabetes
* Pregnant, lactating, or plans to become pregnant during course of the study
* Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment
* Current or acute conditions involving cystitis or urethritis
* Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures
Ultrasound-induced Adipose Tissue Cavitation and Training in Obesity

The addition of ultrasound-induced adipose tissue cavitation (UATC) at the level of the abdominal subcutaneous adipose tissue may seem relevant as an additive treatment option to exercise intervention in individuals with obesity. However, whether individuals with obesity who participate in an exercise intervention and additionally undergo UATC, are more likely to develop a metabolically healthy phenotype, as opposed to subjects with obesity undergoing exercise training or UATC only, remains to be studied. Therefore, the first aim of this study is to examine the impact of combined UATC during exercise intervention on abdominal subcutaneous and whole-body adipose tissue mass, quality of life and cardiometabolic risk in individuals with abdominal obesity.


Eligibility Criteria:
Inclusion Criteria:

* male/female (1:1),
* age 18-65 y,
* abdominal obesity (waist circumference \>102cm or \>88cm) -

Exclusion Criteria:

* involvement in dietary or exercise intervention in the last year,
* intake of any medication,
* clinically diagnosed diseases (cardiovascular disease, hypertension, venous thromboses blood diseases, presence of a pacemaker/defibrillator, brain or nervous system diseases, kidney, thyroid or liver disease, chronic inflammatory diseases, cancer, osteoporosis and epilepsy).
* Persons with a pregnancy,
* a recent bone injury or the presence of a metal prothese
Effects of Therapist Behavior on the Treatment of Depressed Adolescents

The purpose of this study is to identify and evaluate therapist behaviors that affect how well and how long adolescent patients stay in treatment for depression.

Early patient drop out, sporadic attendance, and minimal participation have hindered the development and administration of effective treatments for adolescent depression. Adolescents who do not receive adequate exposure to active treatment are unlikely to benefit from experimentally supported treatments. Certain therapist behaviors may influence the attendance, drop-out, and overall participation of adolescents with depression. This study will evaluate the effect of engagement interventions and alliance on attendance, participation, completion, and outcome in depressed adolescents.

Participants in this study will have 12 weekly sessions of cognitive behavioral therapy (CBT) at a school-based health clinic. Audio recordings from the completed CBT sessions will be replayed and evaluated to identify therapist engagement interventions, therapy alliance, and treatment participation.

Eligibility Criteria:
Inclusion Criteria:

* Major depression or dysthymic disorder
* Referred by school

Exclusion Criteria:

* Comorbid psychosis, bipolar disorder, or mental retardation