cyrilzakka/clinical-trials huggingface dataset:
Atorvaststin and Cardiotoxicity in Acute Myloid Leukemia

The research proposal focuses on evaluating the efficacy of atorvastatin in reducing cardiotoxicity caused by anthracycline chemotherapy in patients with hematologic malignancies, specifically acute myeloid leukemia (AML) and non-Hodgkin lymphoma (NHL). The study will be conducted at Assiut University Hospitals and will include patients aged 18 or older receiving anthracycline-based treatments (3+7 regimen for AML and CHOP regimen for NHL).

The background highlights that anthracyclines, a class of chemotherapeutic agents, can cause serious side effects, particularly cardiotoxicity. The research aims to investigate whether atorvastatin, a statin used to lower cholesterol, can mitigate this risk by improving cardiac function in patients undergoing chemotherapy.

The study will be a randomized controlled trial with a sample size of 46 participants. It will assess left ventricular ejection fraction (LVEF) as the primary outcome to determine the effect of atorvastatin on reducing cardiotoxicity. Secondary outcomes include identifying high-risk patients and further understanding the impact of atorvastatin.

The study also adheres to ethical guidelines, ensuring patient consent and confidentiality. Data analysis will be performed using IBM SPSS, and results will be disseminated in scientific journals, with support from Assiut Medical School's Grants Office if funding is approved.


Eligibility Criteria:
Inclusion Criteria:

Age \>18 years Patient with hematologic malignany ( Acute myeloid leukemia on 3,7 regimen or non-Hodkin Lymphoma on CHOP regimen) Cardiac function with EF ≥60%

Exclusion criteria:

Cardiac dysfunction with EF \< 60% Other hematologic malignancies Pregnant women and breastfeeding Patients refuse participate in research
Renal Impact of KAFTRIO in Mucoviscidose Population

The objective of this study is to describe the renal impact of Elexacaftor-Teacaftor-Ivacaftor, a triple modulator therapy of CFTR channel, in patients with cystic fibrosis. This new treatment acts on the CFTR channel, which is expressed at the level of the nephrons. The objective is to study the changes in plasma and urinary parameters, including metabolic explorations of urolithiasis, change in volemic parameters, renal function, urinary sediment and nutritional and glycemic parameters, in newly treated patients, through the data collected at introduction of the treatment and during the follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patient with cystic fibrosis
* More than 18 years old
* Eligible for KAFTRIO

Exclusion Criteria:

* KAFTRIO contraindication
* Patient less than 18 years old
* Dialysis patient
* Pregnant woman
* Greffed patient
* Patient opposition to data collection
Comparison Cytokine Clearance Between SLED-f Using High Cut-off Dialyzer and High-flux Dialyzer in Septic AKI Patients

Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high mortality in sepsis-related acute kidney injury(AKI). This pilot randomized controlled trial was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO dialyzer(HCO-SLED-f) and HF dialyzer(HF-SLED-f).

Hypercytokinemia contributes a major role in the pathogenesis and is associated with the high mortality in sepsis-related acute kidney injury(AKI). Reductions of these cytokines have been reported to improve clinical outcomes. Online sustained low-efficiency diafiltration(SLED-f) using traditional high-flux(HF) dialyzer could remove some cytokines. Interestingly, the potential of enhancing cytokine removal by using newly designed high cut-off(HCO) dialyzer that could theoretically remove larger molecular weight solutes has never been studied in SLED-f before.This pilot randomized controlled trial was conducted in sepsis-related AKI patients to compare the efficacy of cytokine removal including interleukin(IL)-6, IL-8, IL-10, and tumor necrotic factor(TNF)-α by six-hour SLED-f between using HCO dialyzer(HCO-SLED-f,n=8) and HF dialyzer(HF-SLED-f,n=8).

Eligibility Criteria:
Inclusion Criteria:

* Sepsis
* Acute kidney injury stage 3

Exclusion Criteria:

* Profound hemodynamic instability with more than one inotropic drug
* Pregnancy
* Breast-feeding
* Delayed receiving antibiotic up to 6 hours after beginning of septic shock.
Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C

The purpose of the study is to investigate how the liver is affected with regard to inflammation and fibrosis during Sofosbuvir based treatment regimes of chronic hepatitis C.

In order to examine how the liver heals, we want to use blood samples to check for the occurrence of special liver inflammation cells (CD163 and CD206). To assess to which extent fibrosis disappear during treatment, we want to examine the liver with FibroScan (a type of ultrasound examination) and also preferably with extraction of a small tissue sample. We want to examine how the liver function as inflammation and scar tissue decrease, especially concerning the liver's ability to produce proteins. Furthermore, we want to examine with a gastroscopy, if the circulation of blood in the liver is improved after successful treatment with the expected result that potential varicose veins in the esophagus vanish.


Eligibility Criteria:
Inclusion Criteria:

* Hepatitis C and initiation of sofosbuvir-based direct-acting antiviral treatment

Exclusion Criteria:

* HIV or Hepatitis B Virus
Identifying Pain Generators and Potentiators of Residual Complaints Following Lumbar Discectomy

Lumbar discectomy (i.e. surgically removing a hernia) is frequently performed in Belgium to treat lumbar radiculopathy. Every year \>12,000 interventions are performed with variable long-term results. The treatment success of this procedure varies and up to 41% of the patients report post-operative persistent pain complaints, and consequently suffer from failed back surgery syndrome (FBSS). Chronic complaints in FBSS following lumbar discectomy are usually treated with symptomatic interventions (including painkillers, neuromodulation, etc), rather than from a biopsychosocial perspective.

In order to develop a focused and effective treatment strategy, it is crucial to first gain insight into how persons with persistent complaints after lumbar discectomy differ from those without persistent symptoms. Different known contributing factors entail type of surgery, muscle and psychosocial impairments. Although in scientific and clinical literature it is assumed that dysfunctional pain processing also plays an important mechanistic role in FBSS, there is a lack of research to support this. However, this knowledge is crucial to depict the full mechanistic picture of pain generators and potentiators in FBSS.

Therefore, we will examine whether residual complaints persisting following lumbar discectomy can be accounted for by underlying dysfunctional pain processing and whether a clinical classification algorithm can be used to identify the predominant pain mechanism in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Dutch speaking
* Body mass index below 35kg/m²
* Lumbar radiculopathy patients, classified as ASA I to II without any symptoms of spinal cord compression (i.e. bilateral leg pain), who are scheduled for a first-time, single-level, unilateral lumbar discectomy
* Healthy, pain-free controls (score 0 on a visual analogue scale from 0 to 100)

Exclusion Criteria:

* Female participants will be excluded if pregnant, lactating or \<1 year postnatal
* Having (a history) of severe medical disorders either respiratory (e.g. cystic fibrosis), orthopedic (e.g. whiplash trauma), neurologic (e.g. cerebrovascular incident), cardiovascular (e.g. severe hypertension), endocrinological (e.g. diabetes), psychiatric (e.g. post-traumatic stress disorder
* Having a history of spinal surgery (e.g. discectomy), spinal traumata (e.g. vertebral fracture) or severe spinal deformities (e.g. spondylolisthesis)
* Having a pacemaker or defibrillator
* Healthy controls will be excluded if having suffered low back pain in the preceding year of score 2 or higher on the visual analog scale and which limited their activities of daily living or for which they consulted a (para)medic.
Alternate Nostril Breathing Training in Geriatrics With Glaucoma and High Blood Pressure

Hypertension, particularly if poorly controlled, appears related to an increased risk of open angle glaucoma, (the high tension type of glaucoma is characterized as optic nerve degeneration with ocular hypertension). so this study will search response of glaucoma to breathing exercise

Hypertension, particularly if poorly controlled, appears related to an increased risk of open angle glaucoma, (the high tension type of glaucoma is characterized as optic nerve degeneration with ocular hypertension). With a random assignment, sixty hypertensive geriatric with high tension type primary open angle glaucoma will be assigned to breathing exercise (alternate nostril breathing) group (n=30 geriatrics) or waiting list geriatrics. the daily breathing exercise will be performed by the geriatrics in evening (for half an hour) and morning (for half an hour).

Eligibility Criteria:
Inclusion Criteria:

* hypertensive elderly
* primary open angle glaucoma in both eyes
* ocular hypertension in both eyes

Exclusion Criteria:

acute or chronic eye inflammation cataract eye surgeries mental ill patients patients who will refuse to participate in the study other systemic /cardiovascular problem
Bladder Capacity as Objective Measure of Intravesical Treatment of Newly Diagnosed IC

A comparative study of subjective outcomes following intravesical treatment of interstitial cystitis (IC) is lacking in the literature. Furthermore, an objective measure to determine the efficacy of intravesical treatment for interstitial cystitis has yet to be defined. Change in bladder capacity following therapy has been investigated; however, a formal statistical analysis of its utility in determining efficacy has yet to be performed. The primary objective of this prospective, randomized study is to determine whether there is a significant difference in subjective improvement in IC symptoms in women with newly diagnosed IC when treated with either dimethyl sulfoxide (DMSO) or bupivacaine, triamcinolone, and heparin (BTH) instillations. The secondary objective is to determine whether change in bladder capacity can be used as an objective measure of response to intravesical therapy for newly diagnosed interstitial cystitis. Our long-term goals are to improve the scientific understanding of therapy for interstitial cystitis, to improve patient counseling prior to initiation of treatment, and to better identify patients likely to receive inadequate relief of symptoms following intravesical treatment so that an alternative treatment can be pursued.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed interstitial cystitis/painful bladder syndrome

Exclusion Criteria:

* History of pelvic radiation, a history of bladder cancer, or a history of bladder resection
Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease

The primary objective of this study is to evaluate whether a management strategy based on coronary computed tomography angiography (CCTA) for patients with non-obstructive coronary artery disease can improve the LDL-C target achievement rate compared to a traditional management strategy without follow-up CCTA, thereby reducing the incidence of major adverse cardiovascular and cerebrovascular events over a 3 years period, including all-cause mortality, myocardial infarction, ischemia driven revascularation and stroke.

Patients with non-obstructive coronary artery disease have a high rate of adverse cardiovascular events, and currently, there is still a lack of effective management strategies for these patients in clinical practice. In the SUCCESS study, investigator will compare follow-up CCTA management with routine clinical management to assess the effectiveness of follow-up CCTA in improving lipid control and reducing cardiovascular events in these patients.

The SUCCESS study is a single-center, randomized, parallel-controlled, interventional clinical trial that recruits patients with non-obstructive coronary artery disease identified on previous CCTA (coronary artery stenosis of 20% to 70% or left main coronary artery stenosis of 20% to 50%). The experimental group is the CCTA follow-up management group, and the control group is the routine clinical follow-up management group. All participants will be randomly assigned to the experimental and control groups in a 1:1 ratio. The experimental group will undergo management using follow-up CCTA, while the control group will be managed using routine clinical and laboratory examinations. At the 1-year follow-up, all participants will undergo laboratory re-examination to observe the impact of follow-up CCTA on lipid target achievement. After 3 years of follow-up, the differences in the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) between the two groups will be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 80 years old;
2. Known patients with non-obstructive coronary artery disease (disease duration ≥2 years);
3. Patients who agree to undergo follow-up CCTA examinations and cooperate in completing follow-up observations.

Exclusion Criteria:

1. Patients who have experienced ACS or PCI/CABG;
2. Patients who have experienced adverse cardiovascular and cerebrovascular events;
3. Patients who have undergone follow-up CCTA or DSA examinations before enrollment;
4. Patients with severe hepatic and renal dysfunction;
5. Patients with contraindications to CCTA examinations;
6. Patients with poor initial CCTA image quality or data loss.
Stapled Anastomosis Versus Hand-sewn for Neonate With Intestinal Atresia

Neonatal intestinal atresia is the most difficult disease to apply stapled anastomosis. However, there are no high-quality clinical trial to verify its effectiveness. Therefore, the investigators compared the outcomes of stapled and hand-sewn anastomosis in neonate with intestinal atresia.

Intestinal anastomosis in neonates with intestinal atresia has traditionally been performed using the hand-sewn end-to-end approach. After the introduction of stapled functional end-to-end anastomosis (FEEA) in neonates and infants by Powell in 1995, the procedure is gradually being accepted among pediatric surgeons. When treating intestinal atresia, great discrepancy between diameters of the proximal and distal intestine caused by disuse atrophy are often observed, which may cause difficulties and complications. To overcome size discrepancy, proficiency in performing anastomosis is required when using hand-sewn techniques. in theory, stapled functional end-to-end anastomosis does not require a special technique and does not impair the passage of intestinal contents immediately after completion because the side-to-side nature of the procedure retains the unique diameter of the target intestine and preserves patency. Stapled side-to-side functional end-to-end intestinal anastomosis is a potentially useful technique that is not affected by intestinal size discrepancy and does not require specialized surgical experience.To date, there have been a few studies about the safety and efficacy of stapled anastomosis in neonates and infants, which reported the efficacy of stapled over hand-sewn anastomosis, including shorter operative time, time to full feeding and hospitalization, and no difference in adverse outcomes between both types of anastomoses. These studies compared the clinical outcomes in neonates and infants. However,there are no high-quality clinical trials to verify its effectiveness. Therefore, the investigators compared the outcomes of stapled FEEA and hand-sewn anastomosis in neonate with intestinal atresia.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if they were between 1 day and 30 days of age, and if they suffered from intestinal atresia.

Exclusion Criteria:

* These patients were complicated with intestinal perforation and peritonitis, instability of vital signs.
* Stapled anastomosis could not be performed when the intestinal lumen could not admit a 22-Fr soft catheter.
Detection and Characteristic of Whipple Diseases in the Great Britany

Whipple's disease is a chronic systemic infection caused by ubiquitous bacterium Tropheryma wipplei on a genetic predisposition which should be considered in patients with recurrent episodes of seronegative arthritis, erosive or not, or inflammatory low back pain, chronic diarrhea, persistent fever, unexplained neurological signs, uveitis, endocarditis, and epithelioid granuloma.

Laboratory tests may show malabsorption, erythrocyte sedimentation rate and C-reactive protein elevation, anemia, thrombocytosis, eosinophilia and lymphopenia.

None of theses findings is specific and most patients have arthritis or low back pain mimicking rheumatoid arthritis and spondyloarthritis.

As the disease is rare, chance for positive polymerase chain reaction testing for Tropheryma whipplei is low in this context.


Eligibility Criteria:
Inclusion Criteria:

* Adult
* patient with at least a screening test for Whipple'disease
* participation agreement,

Exclusion Criteria:

* No test for Whipple'disease
Red Cell Distribution Width (RDW) as a Prognostic Marker in ICU

The aim of this study is to verify if high values of RDW are useful prognostic marker for ICU mortality and 90-days mortality. Moreover, we will investigate the prognostic value of RDW in specific subgroup population with some clinical characteristic wich may modify RDW baseline values, i.e. transfused patients or patients with high markers of hemolysis


Eligibility Criteria:
Inclusion Criteria:

* Unselected ICU patients

Exclusion Criteria:

* Length of stay in ICU \<48 hours
* Hematological disease
* Age \<18 years
A Study to Assess Electrocardiogram Results in Healthy Volunteers Receiving Canagliflozin (JNJ-28431754)

The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) on electrocardiogram results (recordings of the electrical activity of the heart) in healthy volunteers after a single therapeutic dose (300 mg) and a single supra-therapeutic dose (4 times higher \[1,200 mg\] than the anticipated therapeutic dose of 300 mg). The safety and tolerability of canagliflozin will also be assessed.

This study will be a randomized (the treatment is assigned by chance), single-center, double-blind (neither investigator nor volunteer knows the identity of the assigned treatment), double-dummy (a technique for retaining the blinded nature of the study when the treatments do not look identical), placebo-controlled (one of the treatments is inactive), positive-controlled (one of the treatments has a known potential effect on electrocardiogram results), four-way cross-over study (all volunteers will receive each of the 4 treatments but in a different order) to assess the effect of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) on electrocardiogram results in healthy volunteers. The study will consist of 3 phases: a screening phase, a double-blind treatment phase, and an end-of study (or follow-up) phase. Volunteers will be assigned to 1 of 4 treatment sequence groups (ADBC, DABC, BCDA, or CDAB). The treatment sequence will be decided by randomization. Treatment A will be a single dose of 300 mg of canagliflozin. Treatment B will be a single dose of 1,200 mg of canagliflozin. Treatment C will be a single dose of placebo (inactive medication). Treatment D will be a single dose of 400 mg of moxifloxacin (an antibiotic with known potential to affect electrocardiogram results). Each treatment will be given during a treatment period of 2 days duration; each treatment period will be separated by a washout period (when no medication is given) of 10 to 14 days. Each volunteer will participate in the study for approximately 61 days.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18 and 35 kg/m2 (inclusive) and body weight not less than 50 kg
* Volunteers must have an average of triplicate 12-lead electrocardiogram (ECG) recordings, taken with a maximum of 2 minutes between recordings, consistent with normal cardiac conduction and function, as specified by the protocol
* Volunteers must be non-smokers

Exclusion Criteria:

* History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
* History of additional risk factors for the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (\<=40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child)
Exploring the Role of At-home Semi-quantitative Pregnancy Tests for Follow-up to Menstrual Regulation Service

The study seeks to test whether it is feasible and acceptable for both women and providers (in this context the Lady Health Visitor) to use the semi-quantitative pregnancy test (SQPT) as a tool for follow up after MR services. The study is planned at 11service delivery points (primary health clinics) in Punjab province where consenting women will be asked to take a baseline test at the clinic the morning they present for the MR procedure. Women will be asked to complete a second test at home the morning of their scheduled follow up visit and return to the clinic for follow-up care later that day. The results of the at home test will be compared to the baseline to determine the outcome of the MR. This is of particular importance because to-date no research has documented the accuracy of the test in detecting MR outcomes with misoprostol only regimens.

We hypothesize that women and providers will find the test easy and acceptable to use thereby improving follow up and simplifying MR service provision. In addition, the simple pictorial instructions will enable most women to use the test and interpret the results correctly on their own.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for medical menstrual regulation services according to clinic guidelines
* Willing to follow instructions and use the SQPT at home
* Agrees to return for a follow-up visit 7 days after receipt of misoprostol for the MR procedure

Exclusion Criteria:

* Not eligible for medical menstrual regulation services according to clinic guidelines
* Not willing to follow instructions and use the SQPT at home
* Does not agree to return for a follow-up visit 7 days after receipt of misoprostol for the MR procedure
Effect of Antiplatelet Therapy on Cognition After Aneurysmal Subarachnoid Hemorrhage

Deficits in memory, executive function, and language are common cognitive sequelae of aneurysmal subarachnoid hemorrhage (aSAH). Previous study demonstrated that post-treatment antiplatelet therapy reduced risk for delayed cerebral ischemia caused by aSAH. However, the effect of antiplatelet therapy on cognition after aSAH is unclear. The aim of this study was to assess the effect of antiplatelet therapy on cognition after aSAH.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with SAH in whom the aneurysm was proven by conventional angiography; 2. Baseline Hunt-Hess grade I-III; 3. patients received endovascular treatment

Exclusion Criteria:

* 1. Hunt-Hess grade IV-V; 2. Non-aneurysmal SAH; 3. Dementia in other diseases; 4. Lacking of 6-8 month MoCA evaluation.