cyrilzakka/clinical-trials huggingface dataset:
The Prevalence of Chronic Critical Illness in Turkey

It is known that the number of Chronic Critical İllnes, an iatrogenic condition, increases all over the world. The prevalence of Chronic Critical Illness in Turkey is unknown. The investigators aimed to evaluate the etiology, comorbid conditions, demographic data, prevalence, mortality and costs of these patient in intensive care units in Turkey. In this multi-centered study, The investigators will retrospectively review the last 1 year of patients receiving treatment at the Adult Intensive Care Unit.

The patients who survive an acute critical illness in the Intensive Care Unit (ICU) may be delayed in a situation where they are sometimes totally independent before hand due to iatrogenic causes such as infections, dysfunctions, psychological disorders. This can take weeks, sometimes months. This disease is called "Chronic Critical Illness" (CCI).

Most researchers associate CCI with the need for prolonged acute mechanical ventilation or the opening of tracheostomy for prolonged acute mechanical ventilation. There is no single condition that does not require an extended mechanical ventilation from CCI. In conclusion, CCI is characterized by long-term care requiring survival and it is predicted that the cost of these patients will increase with the new patients whose cost will be added in the coming years. In the United States, the number of CCI is around 250,000, and this figure has increased by 50-100% in the last 10 years. At least 50% of these patients die in one year and less than 12% recover and become discharged. The annual cost of these patients' health care system is over $ 20 billion. The prevalence of CCI in Turkey is still unknown. In this study, it was aimed to investigate the prevalence of patients with Chronic Critical Syndrome in intensive care units in Turkey.

Eligibility Criteria:
Inclusion Criteria:

The patient who is over 18 years old, taking mechanical ventilation support and staying in the critical care unit at least 8 days. Additional criterias; Clinical diagnosis of following situations:

1. Prolonged mechanical ventilation
2. Tracheotomia
3. Sepsis
4. Serious injury (burn)
5. Stroke ( hemorhagic or ischemic)
6. Traumatic brain injury

Exclusion Criteria:

1. The patients who not having mechanical ventilation support
2. The patient staying less than 8 days in the intensive care unit
3. The patient younger than 18 years old
Effect of Whole-body Vibration on Insulin Resistance in Obese Postmenopausal Women.

This study will be conducted to investigate the Effect of whole-body vibration on insulin resistance in obese postmenopausal women

The prevalence of obesity has tripled over the past four decades, imposing an enormous burden on people's health.

Obesity is associated with premature mortality and is a serious public health threat that accounts for a large proportion of the worldwide non-communicable disease burden, including type 2 diabetes, cardiovascular disease, hypertension, and certain cancers.

reported that "Whole-body vibration (WBV) training has been established as a useful method to improve physical fitness in obese individuals. Vibration stimulus during half squatting might suggest a long-term effect of WBV on the endocrine system. Therefore, in this study, The aim to investigate the effect of whole-body vibration on insulin resistance in obese postmenopausal.

Eligibility Criteria:
Inclusion Criteria:

* All women were postmenopausal with no menses at least 1 year.
* Their ages were ranged from 50-60 years old.
* Their body mass index (BMI) \> 30 kg/m2.
* They were not engaged in any other treatment program.

Exclusion Criteria:

* Women with body mass index (BMI) \< 30 kg/m2.
* Any cardio-respiratory diseases.
* Diabetes mellitus.
* with malignancy.
* with severe hemorrhage, acute viral disease and mental disorders.
* Smokers.
* Women with life threatening disorders as renal failure
A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001).

Epstein Barr virus (EBV) is a virus which can cause infectious mononucleosis and is associated with certain kinds of cancer and multiple sclerosis. Researchers are looking for new ways to prevent disease related to EBV and have developed a new study vaccine (V350A and V350B). The main goal of this study is to learn about the safety and tolerability of V350A and V350B in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization.
* Has a body mass index (BMI) ≥18 and ≤35 kg/m\^2, inclusive.

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a confirmed or suspected case of infectious mononucleosis within 12 months prior to enrollment.
* Has any immunosuppressive medical condition or receive any immunosuppressive therapy.
Ultrasonography Assessment of Peripheral Entheses in Axial Spondyloarthritis and in Healthy Subjects, Athletes or Not

Purpose:

* Assessment of ultrasound MASEI index in axial spondyloarthritis and in healthy subjects, athletes or not
* Comparison of the ultrasound semiology of enthesitis in the 3 populations
* Comparison of the MASEI scores in the 3 populations


Eligibility Criteria:
Inclusion Criteria:

* - Axial spondyloarthritis according to the ASAS classification criteria
* 18-45 years old
* Athletes are defined by sport activities greater than or equal to 6 hours per week
* Non athletes are defined by sport activities lesser than or equal to 1 hour per week

Exclusion Criteria:

* - History of heel or ankle surgery
* Recent corticosteroid infiltration of the heel or the ankle
Low-dose Evaluation of Aspirin After STEMI Patients With PCI: A Multicenter, Double-blind, Randomized Controlled Clinical Trial

The study aims to optimize the dual antiplatelet therapy regimen for patients with STEMI after PCI, focusing on addressing the following key technical challenges: establishing an effectiveness evaluation system for a low-dose aspirin (50mg/day) antithrombotic treatment strategy based on ticagrelor, including the formulation of a scientific non-inferiority margin, assessment criteria, and composite endpoint determination standards; constructing a strict risk assessment system for major bleeding events, including bleeding event grading based on BARC standards and a blind evaluation process by an independent endpoint event adjudication committee; and developing a quality control system for multicenter clinical research to ensure patient follow-up compliance and data reliability. By solving the above technical challenges, the study provides evidence-based medical support and technical support for optimizing the antithrombotic treatment regimen for STEMI patients after PCI.


Eligibility Criteria:
Inclusion Criteria:

STEMI patients with clear diagnosis Has received PCI treatment (at least the culprit's blood vessels have been treated); 18 years old and above, regardless of gender; Received DAPT upon discharge: aspirin+ticagrelor; Signed informed consent form approved by the ethics committee

Exclusion Criteria:

Individuals with atrial fibrillation/DVT/valve surgery requiring anticoagulant medication; Combined cardiomyopathy (HCM/DCM/RCM); Combining severe ventricular arrhythmias requires ICD; Chronic obstructive pulmonary disease (bronchial asthma, chronic bronchitis, emphysema, pulmonary heart disease); Serious infectious diseases, including active hepatitis B, hepatitis C or AIDS patients; Diseases of the blood system, such as thrombocytopenia, severe anemia, leukemia, etc; Severe liver and kidney dysfunction; Malignant tumors; Cognitive impairment
Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).

This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.

This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.

Participants ≥50 years old diagnosed with GA secondary to dry AMD and who meet all inclusion criteria and none of the exclusion criteria will be included in the study. The study will randomize up to 246 participants in a 1:1 manner (123 participants per treatment group) to receive a single daily dose of either CT1812 (200 mg) or placebo across approximately 40-50 sites.

Following a screening period of up to 60 days, the total expected duration of participant participation in the study will be 108 weeks (104-week treatment period followed by a 28-day \[4-week\] post treatment safety follow up period).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥50 years at time of informed consent.
2. BCVA of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at screening.
3. Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.

EXCLUSION CRITERIA:

1. GA due to causes other than dry AMD.
2. Any history or current evidence of exudative ("wet") AMD.
3. Retinal disease other than dry AMD.
4. Any ophthalmologic condition that prevents adequate imaging of the retina as judged by the study site or central reading center.
5. Intraocular surgery (including intraocular lens implantation surgery) within 3 months prior to randomization.
6. Any ophthalmic condition that will or is likely to require surgery during the study period.
7. Hypersensitivity to fluorescein.
8. Suspected or known allergy to any components of the study treatments.
9. History of vitrectomy surgery, submacular surgery or any other surgical intervention for dry AMD.
10. History of glaucoma filtering surgery or corneal transplant in the study eye.
11. History of central serous retinopathy in either eye.
Risk Factors of Poor Bowel Cleansing in Inpatients

The main purpose of the study is to determine risk factors of poor bowel cleansing in inpatients after a split-dose high volume preparation with 4 liters of polyethylene glycol. The quality of colon cleansing will be measured by the Boston bowel cleansing scale (more than or equal to 2 points in each segment). The secondary aim is to design a predictive score of poor bowel cleansing.

It is well-known that inpatient status is a risk factor of inadequate bowel preparation. However this is a very mixed group, coexisting multiple factors containing several risk factors, such as elderly, comorbidities, a variety of medications, physical inactivity... Predictive factors in this population are probably different to those identified in outpatients. There is no strong evidence about the influence of these factors on inpatient bowel cleansing.

The researchers will offer to participate in the study to inpatients scheduled for colonoscopy who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information on the diet and the bowel cleansing solution to be taken. A questionnaire will be administered about predictors of inadequate bowel cleansing. Activity will be measured by using a pedometer and a physical performance test.

Patients will take a liquid diet the day before the examination and they will be prepared with 4 liters of polyethylene glycol in split-dose regimen: 2 liters the evening before the examination (at 19.00 hours) and 2 liters 5 hours before colonoscopy The bowel cleansing quality following Boston Bowel Preparation Scale will be assessed by the endoscopist during the colonoscopy.

The aim of this study is to figure out the risk factors of bowel cleansing of inadequate bowel preparation in inpatients.

The inclusion of a maximum of 10 variables in the multivariate analysis will be considered: age, sex, short test of physical performance, Charlson index, indication (urgent or scheduled), polymedication (≥ 5 drugs), exposure to tricyclic antidepressants, calcium antagonists or opioids, constipation (\<3 deposits per week and one of the following defecatory efforts), number of steps. For a predetermined percentage of 25% of patients with inadequate preparation, the inclusion of 400 inpatients who undergo a colonoscopy will be required. If we estimate an inclusion of about 10 patients per week, an inclusion period of about 10 months would be required.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients with an indication of a colonoscopy
* Age ≥ 18 years.

Exclusion Criteria:

* Patients with previous colon surgery
* Last colonoscopy with poor bowel preparation.
* Ileus, intestinal obstruction, megacolon.
* Poorly controlled hypertension (Systolic and diastolic blood pressure \> 180 and \> 100, respectively).
* Terminal renal failure (pre-dialysis or dialysis).
* Congestive heart failure (NYHA III-IV).
* Acute liver failure.
* Severe psychiatric illness.
* Pregnancy or breastfeeding.
* Refusal to participate in the study.
Effects of 23-gauge Lensecotomy Combined With Anterior Vitrectomy on Macular in Children With Congenital Cataract

Congenital cataract is the main cause of form deprivation amblyopia in children. Current studies confirm that form deprivation amblyopia affects the macular development. However, there are different opinions about the effect of amblyopia on the macular thickness . Investigators have performed "cataract extraction with IOL implantation" on children with bilateral and unilateral congenital cataract. Investigators used OCT biometry to measure children's the macular thickness before and after surgery..Average sectional total thickness was automatically determined by the instrument's software using a modified Early Treatment Diabetic Retinopathy Study (ETDRS) circle grid (fovea, inner ring, and outer ring: 1 mm, 3 mm, and 6 mm. Investigators dynamically observed changes in macular to explore the retinal mechanism of form deprivation amblyopia and help guide the clinical correct understanding of postoperative follow-up time.


Eligibility Criteria:
Inclusion Criteria:

* congenital cataract

Exclusion Criteria:

-incooperative to complete the preoperative and postoperative examinations.
Tumor Gene Expression in Women With Ovarian Cancer

The study objective is to compare changes in expression of glucocorticoid-induced genes that may be involved in cell survival signaling in the tumors of ovarian cancer patients before and after an intraoperative dose of 20mg dexamethasone.

This trial will examine the upregulation of dexamethasone-inducible genes in the tumors of ovarian cancer patients undergoing surgical debulking. A core biopsy of tumor will be taken at the first opportune time during surgery. Dexamethasone 20 mg IV will then be administered, and a second biopsy taken 30 minutes later. Samples at two and four hours later will also be obtained if surgery is still in progress and biopsiable tumor remains. Tissue will be snap-frozen. Subsequently tumor will be microdissected out from stroma, and tumor RNA will be extracted for gene expression profiling. Sixteen patients with epithelial ovarian cancer receiving dexamethasone will be studied, and an additional eight patients with epithelial ovarian cancer will receive a small saline (placebo) injection and serve as controls. Enrollment is limited to those patients with a serum albumin of at least 3.0 g/dL to minimize any theoretical adverse effect of a single dose of dexamethasone on wound healing.

Eligibility Criteria:
Inclusion Criteria:

* Subject has intraabdominal disease either proven or strongly suspected to be ovarian or primary peritoneal cancer, and will be undergoing surgical debulking.
* Subject is not allergic to dexamethasone, and there is no obvious medical contraindication to dexamethasone.
* Subjects with diabetes requiring drug therapy are excluded.
* Subject is not currently receiving glucocorticoid therapy
* Nasal steroids (e.g. Flonase) are permitted
* Subject understands that this protocol does not have therapeutic intent
* Preoperative serum albumin at least 3.0 mg/dL
* Negative serum or urine pregnancy test in women of childbearing potential
* Signed informed consent

Exclusion Criteria:

* Males do not get ovarian cancer and therefore will not be included in this trial.
* Patients of all ethnic backgrounds are eligible and will be encouraged to enroll. However we do not expect differences based on ethnicity, and this small study will not therefore be powered to make conclusions about ethnic differences in induction of GR-regulated genes with dexamethasone.
AutoloGel Therapy to Usual and Customary Care in Pressure Ulcers

The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort-controlled trial in which pressure ulcers will be treated using AutoloGel and standard care and case-matched against a concurrent cohort of patients receiving undefined Usual and Customary Care.

Pressure ulcers (PUs) are a common problem in all patient care settings, especially long-term acute care facilities and nursing homes. AutoloGel is a platelet-rich plasma gel used in the treatment of non-healing chronic wounds. The results of AutoloGel to date when used to treat PUs have been promising. The aim of this trial is to demonstrate the effectiveness of complete wound healing in a prospective, open-label, case-matched cohort trial in which pressure ulcers will be treated using AutoloGel and standard of care to determine time to heal at 16 weeks. Comparison will be made with a case matched concurrent cohort of patients receiving undefined Usual and Customary Care.

Eligibility Criteria:
Inclusion Criteria:

1. Medicare/Medicaid eligible
2. ≥18 years of age
3. Ulcer of pressure/shear etiology (Stage II, III, and IV, see Appendix 9 for stage definitions)
4. The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (Index Ulcer) that is located on the heel, ischium, sacrum, and trochanter
5. For subjects with potentially multiple eligible PUs, the largest ulcer will be selected.

   There must be at least 4 cm between the Index Ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
6. Debrided ulcer size between 3 cm2 and 200 cm2
7. Demonstrated adequate offloading regimen
8. Duration ≥ 1 month at first visit
9. Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.

Exclusion Criteria:

1. Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
2. Stage I pressure ulcers
3. Ulcers that are unstageable or of deep tissue morphology that have yet to become an open wound
4. Presence of another wound that is concurrently treated and might interfere with treatment of index wound by AutoloGel
5. Ulcer not of PU pathophysiology (e.g., pure diabetic, vasculitic, radiation, rheumatoid, collagen vascular disease, venous, or arterial etiology)
6. Any malignancy other than non-melanoma skin cancer
7. Subjects who are cognitively impaired and do not have a healthcare proxy
8. Serum albumin of less than 2.5 g/dL
9. Plasma Platelet count of less than 100 x 109/L
10. Hemoglobin of less than 10.5 g/dL
11. Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration.

10. Life expectancy of \< 6 months.
National Registry and Blood Bank of Patients With Liver Cancer

RATIONALE: Gathering health information about patients with liver cancer over time may help doctors learn more about the disease and may help the study of cancer in the future.

PURPOSE: This clinical trial is developing a national registry and blood bank of patients with liver cancer.

OBJECTIVES:

* Evaluate etiologic factors associated with hepatocellular carcinoma (HCC) in different ethnic groups and in different parts of the United States by developing a national registry of HCC patients.
* Survey stage and potential treatability of HCC patients referred to Vanderbilt University Hospital.
* Establish a serum repository for registry patients with samples to be used for future studies of the pathogenesis of chronic liver disease and HCC and for developing better diagnostic tests.

OUTLINE: This is a multicenter, cross-sectional database study.

Data are collected on patients diagnosed with hepatocellular carcinoma at Vanderbilt University Medical Center and at other participating hospitals or liver transplantation centers around the country for inclusion in a national registry of liver cancer patients. Registry data are collected at baseline and then every 6 months for up to 5 years. The data are derived from investigator interviews with patients and from medical chart review of routine medical care provided during the course of the study. Data are collected from all study sites and entered into a master database that includes information on patient demographics, diagnoses and staging details, treatment history, results of laboratory studies, and patient outcomes. Information derived from the registry is available to investigators at all study sites.

Patients in the registry also undergo blood collection at baseline. Blood samples are stored in a serum repository for evaluation in future studies related to liver disease, viral hepatitis, and liver cancer. A biological marker that may be analyzed is squamous cell carcinoma antigen immune complex (SCCA-IC).

PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for the Vanderbilt University Medical Center study and up to 2,000 patients for the national study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hepatocellular carcinoma at a participating institution

Exclusion Criteria:

* None
The Effectiveness of Sertraline in Patients Who Have Had Inadequate Response to Escitalopram

The purpose of this is to determine the efficacy, safety, and tolerability of sertraline in patients with major depressive disorder (MDD) who have shown inadequate response ot escitalopram.

Eight week open-label flexible dose trial in adult outpatients diagnosed with Major Depressive Disorder (MDD) who have had a prior failure with escitalopram. Failure is operationally defined as either premature discontinuation because of side effects or the report of an incomplete response to escitalopram, minimum dose 10mg/day, maintain for 3 weeks or more. 10mg/day was chosen because 1) it is the most commonly prescribed single dose of escitalopram in clinical practice, 2) it is equivalent to approx. 30mg/day of arcemic citalopram and 3) escitalopram has very high potency at the serotonin transporter (Ki=1.1); this means that escitalopram would be expected to saturate the transporter at relatively low doses. A total of twenty patients will be treated.

Eligibility Criteria:
Inclusion Criteria:

* Primary DSM-IV diagnosis of Major Depressive episode of MDD without psychotic symptoms. Additional axis I diagnoses will be permitted only if they are identified as secondary diagnoses
* Ham-D 21 item score of greater than or equal to 18
* Age 18 and above
* Ability and willingness to provide consent for participation
* Failure to respond to escitalopram

Exclusion Criteria:

* Diagnosis of Bipolar Disorder or any psychotic disorder
* Alcohol or drug abuse or dependence currently or in the last 6 months
* A history of non-response or intolerance to sertraline at least 50 mg. for at least 4 weeks or more
* Concomitant use of another antidepressant or use of an antidepressant within 2 weeks of baseline (4 weeks for fluoxetine)
* Use within 1 week of baseline, or concomitant use of any psychotropics with the exception of zolpidem for sleep
* Use within 4 weeks of baseline or concomitant use of benzodiazepines with the exception of PRN use of diazepam 10 mg/day or its equivalent
* Presence of serious and/or unstable medical condition
* Score of 3 or 4 on the suicide item (item 3) of the Ham-D scale
* Known sensitivity of sertraline