cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Hemorrhagic and Ischemic Strokes Among Blacks and Whites

Our primary goal is to study temporal trends in the incidence rate, causes, treatment, and outcome of stroke among a large biracial metropolitan population of 1,349,351, of whom 215,611 (15%) are black (2000 Census). Such data are critical for the planning, intervention, and evaluation of public health efforts to decrease the mortality and morbidity due to stroke in the United States.

We have completed this goal for 1993-94, 1999, 2005, 2010 and 2015. We are in the process of collecting this data for 2020. In the 2020 study period we will also be ascertaining 3 year recurrence rates for all incident stroke events.

For calendar years 1993-94, 1999, 2005, 2010, 2015, and 2020 we will or have identified every hospitalized or autopsied stroke and transient ischemic attack (TIA) at all regional hospitals in our region. We will also estimate the number of non-hospitalized strokes and TIAs by screening for potential cases at more than 100 outpatient sites throughout five counties in Greater Cincinnati/Northern Kentucky. We plan to identify and abstract detailed information from the medical record for every potential case. These results will be compared with data from all stroke patients identified by similar methodology in all study periods.

In addition, we have interviewed 1500 ischemic stroke patients and/or their families in the study periods 1999-2010 to obtain detailed information including demographic information, functional outcome and quality of life, access to and type of rehabilitation therapy, social support, caregiver availability and health status, access to post-hospital care, health insurance status, current health status, medications, prior risk factors, and knowledge about stroke signs and symptoms. We also obtained genetic material via a blood sample for most of this cohort.

Eligibility Criteria:
Inclusion Criteria:

* ischemic stroke
* occurred in 1999/2005/2010
* \>18 years old
* resides in 5 county region

Exclusion Criteria:

* \<18 years old
* resides outside 5 county region
* inability to consent or have legal proxy consent
Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction

A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'URSA SOFT CAP. (UDCA-003)' in fatigue patients with liver dysfunction


Eligibility Criteria:
Inclusion Criteria:

* CIS greater than or equal to 76, HADS less than or equal to 10
* ALT greater than upper limit of normal OR fatty liver on US

Exclusion Criteria:

* Subjects who have diseases that can cause fatigue
* Subjects who are taking medication that can cause fatigue
Follow up After TACE by Elastography and Color Doppler.

To determine accuracy of elastography and color Doppler in follow up of patients with HCC after TACE comparing with modified RECIST criteria.

The incidence of liver cancer is one of the highest in the world. In Egypt HCC is the forth common cancer and represents up to 90% of all liver malignancies. Where it is responsible for 33.63% and 13.54% of all cancers in males and females respectively.

Transarterial chemoembolization (TACE) is recommended as the first-line treatment in early stage patients with hepatocellular carcinoma (HCC) or as a palliative treatment modality in advanced patients with unresctable tumor which was known to increase survival rate. However, tumor control usually requires multiple TACE interventions due to the presence of residual and recurrent lesions.

Currently the Response Evaluation Criteria in Solid Tumors (RECIST) guideline was proposed as a method for measuring treatment response based on tumor shrinkage, which is a valuable measure of antitumor activity of cytotoxic drugs, Which adapted the concept of viable tumor-tumoral tissue showing uptake in arterial phase of contrast-enhanced MSCT abdomen.

Elastography can provide information about tumor stiffness to predict tumor response after TACE and detect any residual or recurrence.

We also use color Doppler in follow up to detect changes in portal pressure and hepatic artries hemodynamics of HCC patients after TACE. Mainly we search for changes in portal vein velocity {PVVel}, hepatic artery resistive index {HARI} and hepatic artery pulsitality index {HAPI}.

Eligibility Criteria:
Inclusion Criteria:

* All patients with hepatocellular carcinoma underwent TACE in South Egypt cancer institute.

Exclusion Criteria:

* Patients with liver metastases.
* Patients with hepatic or perihepatic inflammations.
Injection Intervals in Real-world Neovascular Age-related Macular Degeneration (nAMD) Patients Switching to Brolucizumab With at Least 12 Months of Follow-up

This retrospective study included nAMD patients whose eyes were grouped into the following cohorts, with the overall cohort receiving ≥ 1 brolucizumab injection; the 12-month and 18-month brolucizumab (BRO) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-vascular endothelial growth factor (VEGF) and had ≥3 brolucizumab injections with no other anti-VEGF in the first 12 months (360 days) and 18 months (540 days) of follow-up respectively; and the 12-month and 18-month alternating (ALT) cohorts, which consisted of nAMD patient eyes who switched from a previous anti-VEGF to brolucizumab and had ≥2 brolucizumab injections and ≥1 injection of another anti-VEGF in the first 12 months and 18 months of follow-up, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of nAMD.
* Patients were on a previous anti-VEGF therapy and then switched to brolucizumab.
* Patients remained on brolucizumab for at least 12 months.
* Patients had exactly 360 days or more of follow-up after first brolucizumab injection.
* For BRO cohort only: Patients received at least three injections of brolucizumab during study period.
* For ALT cohort only: Patients received at least two injections of brolucizumab and one injection of another anti-VEGF during the study period.

Exclusion Criteria:

* For BRO cohort only: Patients who received any other anti-VEGF therapy during the 12-month follow-up period.
* Eyes missing bilaterality information in their nAMD diagnosis.
* Eyes missing bilaterality information in their brolucizumab injections.
Enteric-coated Mycophenolate Sodium Versus Azathioprine for the Extra-renal Lupus Manifestations

Azathioprine is still considered the treatment of choice for the non-renal manifestations of systemic lupus erythematosus (SLE) with an estimated efficacy of 45%.Recently, several studies have demonstrated the efficacy of mycophenolate mofetil/enteric-coated mycophenolate sodium in those cases, but so far, no controlled, randomized comparative study between the two drugs has been conducted. The aim is to perform a randomized, controlled, phase III/IV study comparing enteric-coated mycophenolate (ECMs) with azathioprine for induction and maintenance therapy of the non-renal manifestations of SLE. Methods: Patients with non-renal SLE flares (SLEDAI≥6 and/or BILAG o 2B refractory to full doses of hydroxychloroquine and prednisolone (≥10 mg/d) or with relapsing flares will be included. Patients will be stratified according the flare severity (moderate (SLEDAI\<12)-severe (SLEDAI≥12)) and randomized (1:1) into two groups of treatment, EMCs (2gr/d) or AZA (2-2.5mg/kg/d) according to TMPT levels for 6 months. Dose will be progressively tapered based on clinical response up to completing a year of treatment. The main aim is the percentage of complete remission achieved ((SLEDAI \<4 and/or absence of any BILAG A o B) at week 12 and 24 for moderate and severe flares, respectively. Secondary objectives include evaluating the reduction in the steroid requirement, number of flares post-treatment, effect on the biological parameters, and impact on quality of life, damage and drug safety. To detect a 20% difference between the two drugs with a 80% statistical power (0.05 alpha error), considering a follow up loss of 20%, a total of 240 patients is required.


Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Fulfill at least 4 of the 11 criteria for the ACR classification
* Any extra-renal flare with an SLEDAI\>6 and/or one BILAG A or 2 B
* Oral corticosteroids\>10 mg/day and HCQ \> 400 mg/day for at least 30 days prior to inclusion

Exclusion Criteria:

* Presence of active renal disease
* Previous intolerance or hypersensibility to any of the active components
* Active infection
* Unmeasurable levels of TMPT
* Pregnancy
* Presence of a severe flare that requires other immunosuppressive treatment for its control
* Any Psychiatric or social condition that did not ensure the patient´s follow-up and patient´s collaboration
* Previous treatment with EC-MPS or Azathioprine in the last 2 months
* Previous treatment with biological therapy in the last 3 months for anti-TNF therapy or in the last year for anti-CD20 therapy
* ALT or GPT \>120 UI/mL non-lupus related in the last 30 days
* Leucopenia \<1000x10E6 non-lupus related in the last 30 days
* Symptoms related to other medical conditions non-lupus related such as antiphospholipid syndrome.
The Veteran Caregiver Reducing Stress Time (VetCareReST) Study

Caring for a disabled adult, particularly those with long-lasting impairment, has been associated with elevated levels of stress, depression and anxiety among caregivers.Recent studies show that veteran caregivers experience higher levels of psychological distress than caregivers in the general population, highlighting the psychological needs of this population. The Veteran Caregiver Reducing Stress Time (VetCareReST) is a randomized control trial designed to test the effectiveness of a mindfulness at reducing stress, depression and anxiety in veteran caregivers in Champaign and Danville County.

Recent estimates indicate that there are 275,000 to one million informal veteran caregivers. Caring for a disabled adult, particularly those with long-lasting impairment, has been associated with elevated levels of stress, depression and anxiety among caregivers. Veteran caregivers are especially vulnerable because of competing demands. For instance, Post 9/11 veteran caregivers are more likely to be the spouse of a veteran, and have experienced the stress of multiple deployments, have a young child in their care, and work outside the home. Recent studies show that veteran caregivers experience higher levels of psychological distress than caregivers in the general population, highlighting the psychological needs of this population. One effective approach at reducing stress, depression and anxiety has been the use of mindfulness training, which has been shown to effectively reduce mood symptoms among professional caregivers. The Veteran Caregiver Reducing Stress Time (VetCareReST) is a randomized control trial designed to test the effectiveness of a mindfulness at reducing stress, depression and anxiety in veteran caregivers in Champaign and Danville County. This study builds on Dr. Lara-Cinisomo's (PI) experience with military spouses. The findings from this trial will serve as pilot data for a large-scale study.

Eligibility Criteria:
Inclusion Criteria:

* Provide unpaid caregiver or support to a veteran
* Must be 18 years of age or older
* Willing to participate for the duration of the project
* Able to track his/her home practice in a handwritten log
* Have no significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance abuse, actively suicidal)

Exclusion Criteria:

* The presence of significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance abuse, actively suicidal)
Chlorhexidine to Prevent Catheter-related Urinary Tract Infection

The study is to investigate whether chlorhexidine (CHG)-based antiseptics is more effective to prevent catheter-related urinary tract infection (CAUTI) among inhospital patients who required Foley catheter insertion. This is a cluster-randomised, step-wedged clinical trial, in which every participated unit will used three different Foley catheter insertion protocols during the study period:

1. Iodine protocol: using 10% povidone-iodine as the primary antiseptic during Foley insertion. This is the routine practice before this study in the participated hospital, as well as many Taiwanese hospitals.
2. CHG protocol: instead of povidone-iodine solution, use 2% aqueous CHG solution as the primary disinfectant during Foley solution.
3. CHG plus protocol: additional to 2% CHG solution, added 0.5% CHG impregnated gel as the lubrication during Foley insertion.

This is a open-labelled, cluster-randomized, step-wedged clinical trial aimed to observe the incidence if CAUTI during the designated study period (12 months for all participated units). All included units will start with the iodine protocol, which is the standard practice in the hospital, and then switched to CHG protocol than CHG plus protocol according to the results of randomization. Each unit will be randomized in to three different groups (A, B, and C):

Group A) 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.

Group B) 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.

Group C) 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.

All unit will be monitored and compared for the occurrence of CAUTI, which is defined in accordance to the definition from the National Healthcare Safety Network (USCDC).

Eligibility Criteria:
This is a cluster-randomized clinical trial. The enrollment is for healthcare units (wards, ICUs) in the participated hospitals rather than individuals. Patients who were admitted in the included unit with be enrolled in our study automatically.

Inclusion Criteria (for units):

* Adult acute care wards or intensive care units, which primarily care for adult patients aged above 18 years.
* Currently not using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
* Had patients who required Foley catheter insertion during the last 12 months prior to inclusion.
* Willing to implant measures to improve the rate of CAUTI, and to participate and follow the study protocol in our study.

Exclusion Criteria (for units):

* Units currently using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
* Wards or intensive care units with patients aged below 18 years of age in their routine practice.
Colostral Milk and Blood IL-6 Levels in Types of Labour

The comparison of serum and colostral melatonin, and IL-6 levels between women with vaginal delivery, emergency cesarean section and elective cesarean section

In this prospective randomized study, the investigators aimed to show the changes in the melatonin levels in colostral milk in spontaneous vaginal delivery,emergency cesarean and elective cesarean section patients and changes in blood IL-6 level before and after the delivery in same patient groups.

the investigators randomized 30 cases for each group for comparisons.Time range seems short in this study but participating hospital setting is a busy maternity hospital thus it will be performed easily.

The purpose of this study is to demonstrate the beneficial effect of spontaneous vaginal delivery on the secretion of melatonin which is solely secreted by the mother and the newborn is dependent on maternal milk oriented melatonin until 12 th week after delivery

Eligibility Criteria:
Inclusion Criteria

* Pregnant women reached term
* Patients with spontaneous vaginal delivery
* Patients preferred cesarean section electively
* Patient who had emergency cesarean section without additional medical or surgical problems

Exclusion Criteria

* Women who had history of intrauterine fetal loss
* Hypertention during pregnancy
* Anemia
* Thyroid diseases
* Patients with chronic diseases
* Smokers
* Drug users
The Management of Perforated Acute Appendicitis in Adult and Pediatric Populations

Patients admitted at Marshall Health - Cabell Huntington Hospital with the diagnosis of acute perforated appendicitis or appendicular abscess larger than 3cm will be admitted and treated with percutaneous drainage and the IV antibiotics for 3 days. If the patient becomes afebrile and has a normal WBC, the patient will stay in the hospital for a single day with oral antibiotics and then will be discharged to continue oral antibiotics for seven more days. If the patient is febrile or has elevated WBC either after the 3 days of IV antibiotics or the single day of oral antibiotics, the patient will complete a course of IV antibiotics for a total of seven days. If still febrile, the patient will undergo further assessment.

A follow up will be conducted \~10 days after discharge from the hospital to determine if the patient is still symptomatic or asymptomatic. Asymptomatic patients will be followed up every month for 3 months, while symptomatic patients will be treated as needed. After 12 weeks, subjects will be randomized to interval appendectomy vs observation. Follow-ups will occur every 3 months for 12 months, when the study will be concluded.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of all ages.
* Clinical and radiological diagnosis by contrast CT scan of acute perforated appendicitis.
* Formal consent for the present study must be signed by the patient or his/her parents
* Patients with initial presentation of a phlegmon (abscess in evolution)

Exclusion Criteria:

* Patients with non-perforated appendicitis
* Presentation with initially non-perforated appendicitis but found perforation at surgery
* Patient with septic shock
* Patients who had previous appendectomy
* Current treatment of malignancy
* Immunocompromised patients
* Positive pregnancy test
* No consent for the study
FNB in ACL Recon Under SA

The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under spinal anesthesia.

This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with anterior cruciate ligament rupture from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo spinal anesthesia for arthroscopic anterior cruciate ligament reconstruction. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.

Eligibility Criteria:
Inclusion Criteria:

* individuals who are scheduled to undergo arthroscopic anterior cruciate ligament reconstruction surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate.

Exclusion Criteria:

* who require simultaneous surgery for concomitant cartilage injury, medial meniscus tear, and lateral collateral ligament tear.
* who have previously undergone surgical treatment within the knee joint.
* who have declined to participate in the research.
* where medical, surgical, or anesthetic complications occurred during surgery.
* other cases deemed necessary by the researchers.
Hypertensive Urgency Treatment and Outcomes in a Northeast Thai Population

Previous studies have reported a high prevalence of hypertensive (HT) urgency. However, these studies have also reported low rates of serious complications, suggesting that rapid blood pressure (BP) reduction may be unnecessary. There are limited clinical data available on this topic in Asian populations. The investigators aimed to determine the basic characteristics, treatment methods, and outcomes in HT urgency patients, both in the emergency room (ER) and at a two-week follow-up.

Previous studies have reported the high prevalence of hypertensive (HT) urgency. However, these studies have also reported low rates of serious complications, suggesting that rapid blood pressure (BP) reduction may be unnecessary. There are limited clinical data available on this topic in Asian populations. The investigators aimed to determine the basic characteristics, treatment methods, and outcomes in HT urgency patients, both in the emergency room (ER) and at a two-week follow-up.

This was a cohort study conducted at Srinagarind hospital, a tertiary-care level university hospital in Khon Kaen, Thailand. The data collection period was from January 2012 to June 2017. The Khon Kaen University Ethics Committee in Human Research approved the protocol. Patients aged 18 years or older who visited the ER with a diagnosis of HT urgency were consecutively enrolled in the study. Patients who were pregnant or lactating had secondary causes of HT, or had incomplete medical records were excluded from the study Office BP was measured using an upper arm cuff oscillometric BP device. The appropriate cuff size for each individual's arm circumference was used. Three BP readings were taken at 30-second intervals with the patient in a sitting position after five minutes of rest. The average of three BP measurements was used for analysis.

Baseline characteristic data were shown as the mean and standard deviation (SD) or percentage. An independent sample t-test was used to compare between groups for continuous variables including age, body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), time of treatment, and the number of medications being administered. A probability value \<0.05 was considered statistically significant. All statistical analyses were performed with SPSS for Mac version 20.0, registered to Khon Kaen University.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older who visited the ER with a diagnosis of HT urgency

Exclusion Criteria:

* Pregnant or lactating
* Secondary hypertension
Randomized Double-blind Trial of Midazolam and Loxapine in Agitated Patients

Neuroleptics are used since a long time in the management of severely agitated patients. Loxapine is routinely used in our country, with, to our knowledge no severe adverse event reported, in this indication.

However, recently, benzodiazepines have appeared interesting in agitated patients, with the use of midazolam.

The aim of this study is to compare midazolam to loxapine in the treatment of severe agitated patients admitted in the emergency department.

Prospective, Randomized, Double-blind, Multicenter study (20 french emergency departments)

Eligibility Criteria:
Inclusion Criteria:

Severely agitated patients (Richard Scale over or equal to 5) between 18 and 65 years old

Exclusion Criteria:

Hypoglycemia hypoxemia patients with known dementia blood pressure \<90 mmHg known cocaine or amphetamine intoxication pregnancy respiratory or liver insufficiency myasthenia sedation before arrival to hospital