cyrilzakka/clinical-trials huggingface dataset:
Ablative Chemoembolization for Unresectable and Large Hepatocellular Carcinoma

The objective of this study is to study the safety and tumor response of ACE for large HCC.

Transarterial treatment has been playing an important role in the treatment algorithm for patients with multifocal or large intrahepatic hepatocellular carcinoma not eligible for surgical resection, transplantation, or local ablative therapy. Among the patient group with intermediate tumor stage, in which the tumor dimension exceeds 10cm, the treatment outcome of conventional chemoembolization (cTACE), chemoembolization using drug eluting beads (DEB-TACE) and radioembolization using yttrium 90 is generally unsatisfactory. Some would consider HCC of size \>10cm a relative contraindication for cTACE because of the poor treatment outcome. However, there is no better alternative treatment for local control of these tumors. Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin has been found to be highly effective for local control of HCC as compared to cTACE in a case-control study. It is hypothesized that ACE is safe and effective for local control of large HCC of size \>10cm.

Eligibility Criteria:
Inclusion Criteria:

1. Signage of a written informed consent
2. Age above 18 years
3. HCC unsuitable for resection
4. Child-Pugh A or B cirrhosis
5. Eastern Cooperative Oncology Group performance score 0 or 1
6. No previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
7. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology.
8. No extra-hepatic involvement on non-enhanced CT thorax and triphasic contrast enhanced CT abdomen.
9. No invasion of portal vein or hepatic vein
10. Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)
11. Total tumor mass \< 50% liver volume
12. Size of any individual tumor \>10cm in largest dimension

Exclusion Criteria:

1. History of acute tumor rupture presenting with hemo-peritoneum
2. Biliary obstruction not amenable to percutaneous or endoscopic drainage
3. Child-Pugh C cirrhosis
4. History of hepatic encephalopathy
5. Intractable ascites not controllable by medical therapy
6. History of variceal bleeding within last 3 months
7. Serum total bilirubin level \> 50 umol/L
8. Serum albumin level \< 25g/L
9. INR \> 1.7
10. Serum creatinine level \> 150 mmol/L.
11. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
12. Arterio-portal venous shunt affecting \>1 hepatic segment on CT
13. Arterial-hepatic venous shunt with hepatic vein opacified in arterial phase on CT
Vancomycin Dose Adjustments Comparing Trough Levels to The AUC/MIC Method Using a Bayesian Approach in a Hospitalized Adult Population

This pilot study is a prospective, randomized, controlled, open-label trial to assess the feasibility of a randomized controlled trial of sufficient quality that would assess the efficacy and safety of vancomycin adjustments according to Area under the curve/Minimal inhibitory concentration (AUC0-24h/MIC) calculated by the Bayesian approach rather than by a trough dosage. Randomization will be stratified according to infection severity. Approximately 60 subjects meeting all inclusion and no exclusion criteria will be randomized to have pharmacists perform vancomycin dose adjustments with AUC0-24h / MIC calculated by the Bayesian approach versus the trough dosage approach.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age;
* Hospitalized patients
* Suspected or confirmed infection;
* Anticipated IV vancomycin treatment for 24 hours or more.

Exclusion Criteria:

* Patients with renal replacement therapy (peritoneal dialysis, continuous renal replacement therapy or hemodialysis);
* Treatment of vancomycin in continuous infusion;
A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer

A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.

We have previously performed a prospective randomized controlled trial on the effect of scheduled second endoscopy upon peptic ulcer rebleeding. We found that the rate of recurrent bleeding was significantly reduced from 13.8% to 5% with a scheduled second endoscopy and appropriate therapy performed within 24 hours after initial hemostasis.

When we look at the studies in the literature employing proton pump inhibitors (PPI) infusion after primary endoscopic therapy, we found that there was also a significant reduction in the rate of rebleeding, the number of operation performed and the transfusion requirement.

Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis. A recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding.

We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers.

Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb
* age 15 - 90 years
* Written consent available

Exclusion Criteria:

* ulcer bleeding not controlled in first endoscopy
* Bleeding from malignant ulcer or tumor
* Bleeding from Dieulafoy lesion/ angiodysplasia
* Bleeding from injection sclerotherapy ulcer
* Patient with ASA category 5
The Effect of Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema

In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema) to receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) .

The study drugs were administered as often as every 4 weeks for 3 months.monitoring of best-corrected visual acuity, CST ( Central Subfield Thickness) by OCT (Optical coherence tomography) was done from base line ,4 weeks, 8weeks after injection.


Eligibility Criteria:
Inclusion Criteria:

* The patient at least 18 years old had type 1 or 2 diabetes who presented with Central DME involvement (defined as retinal thickening involving 1mm central sub field thickness(CCT)
* Have at least a BCVA ( best corrected visual acuity) between 20/50 to 20/320 Snellen equivalent
* Have received to anti-VEGF( anti -vascular endothelial growth factor) and laser treatment within the previous 3 months

Exclusion Criteria:

* Uncontrolled glaucoma/uncontrolled diabet , high risk PRP(pan-retinal photocoagulation), one eye
* Prior treatment with intravitreal or peribulbar injection and laser therapy during the last 3 months
* Substantial cataract, history of uveitis
* Macular edema due to a cause other than DME
* VMT(Vitreomacular traction ) and ERM (epiretinal membrane)
Universal Genetic Testing Versus Guidelines-Directed Testing for Germline Pathogenic Variants Among Non-Western Patients with Breast Cancer

The study aims to examinethe pattern and frequency of pathogenic variants among all newly diagnosed breast cancer patients in a genetically distinct population. Additionally, the uptake rate of "cascade family screening" , frequency of pathogenic variants and barriers against testing will be studied.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient, age ≥ 18 years at time of cancer diagnosis
* Pathology proven diagnosis of breast cancer (including DCIS); any stage. (prior history of cancer is allowed)
* Willingness to participate
* Signed consent form.

Exclusion Criteria:

- Major psychiatric disorder (defined as: patients followed by a psychiatrist and on antipsychotic medications
Next-Generation Synbiotic in Individuals With Overweight or Obesity

This study plans to evaluate the effect of consuming a symbiotic (probiotic + prebiotic) for 3 months on body weight, body composition, glucose sensitivity, and psychological parameters, as well as on gut and blood microbial composition. Synbiotic consumption is preceded by a 3-day antibiotic course to help ensure the opening of new niches (houses) for the upcoming beneficial bacteria.

This is a triple-blinded, randomized clinical trial in which participants will be allocated to one of two groups: 1) 3-day antibiotic followed by synbiotic consumption for 3 months or 2) 3-day antibiotic followed by placebo consumption for 3 months.

Blood and stool samples will be collected before the antibiotic, and before and after the symbiotic intervention in both groups.

Gut microbial composition will be analyzed through whole genome sequencing and blood microbial composition through 16S rRNA.

Glucose sensitivity will be measured through fasting glucose, fasting insulin, and HbA1c.

Body composition through DXA and BodPod will be measured before and after the symbiotic intervention.

Psychological questionnaires such as the Beck Anxiety and the Beck Depression Inventories, as well as the RED-9 questionnaire to respectively measure anxiety, depression, and food cravings, will be applied before and after the symbiotic intervention.

Eligibility Criteria:
Inclusion Criteria:

* be between 18-50 years of age
* have a BMI between 25.0-40.0

Exclusion Criteria:

* are following a vegetarian, vegan, carnivore, or keto diet
* currently taking metformin, GLP-1 agonists, insulin, or fiber
* have taken antiacids, laxatives, probiotics, or medication that affects your immune system in the past month
* pregnant, planning pregnancy during the study period, or lactating
* have a history of inflammatory bowel disease, colon cancer, or chronic polyps
* have been diagnosed with type 1 or type 2 diabetes
* have active cancer
* are currently participating in a weight loss intervention (dietetic or medication)
* have used antibiotics, antifungals, or antivirals in the past 3 months
* have had a history of recent (within 30 days) diarrhea illness
* have a known allergy to any component of the study product
* have had an acute inflammatory infection or inflammatory condition in the past 4 weeks
* have had \>10% weight variation in the past 6 months
* have had any bariatric surgery
Metabolic Effects of Pulse Consumption on Biomarkers in Adults With Type 2 Diabetes or Met Syn

The purpose of this study is to determine glycemic response of four different meals containing either whole green peas, whole lentils, powdered green peas, or powdered lentils in comparison to Glucola. Participants are adults with type 2 diabetes mellitus or metabolic syndrome.

The 5 test treatments (Glucola, whole green peas, green pea flour, whole lentils, and lentil flour) will be administered randomly over five weeks. The test Participants will be required to consume the entire test treatment meal in 12 minutes while being observed. Venous blood samples will be collected for blood glucose and insulin levels at time 0 (fasting) and at 30, 60, 90, 120, and 180 minutes post-treatment (timing of the post-treatment blood draws started at time 0 \[post-treatment\], which is when the participant finishes consuming the treatment meal). During the first visit blood was drawn for a lipid panel and HbA1C values. Thyroid stimulating hormone (TSH) and complete blood count (CBC) values were analyzed during the second visit, and vitamin D levels analyzed during the final visit. Blood analysis was completed by a reputable biomarker diagnostics laboratory, Quest Diagnostics. Anthropometric measures such as weight, height, waist circumference, and blood pressure were collected at screening and at the start of each test day. Thirteen hours before testing, participants consumed a standardized frozen meal to reduce the potential variation in glycemic responses on test day due to varying pre-evening dietary intakes. This control meal was selected by each participant before the start of the study. Each participant was provided the same frozen meal every time, since the subjects serve as their own controls. The day before test day, participants completed a 24 hour food recall, satiety, and gastrointestinal questionnaires. The morning of each test day participants completed the International Physical Activity Questionnaire (IPAQ), satiety, and gastrointestinal questionnaires. Test meal and blood glucose results at the 5 test points were entered into SPSS statistical software (V. 25) for data cleaning and analysis. Physical activity and the 24 hour dietary recall data were used to classify individuals on activity and dietary quality. Satiety responses were compared against each of the 5 test meals for each participant as well as the gastrointestinal responses using SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Age 24-70 years
* BMI between 22-40
* Medical diagnosis of type 2 diabetes
* HbA1C \<10%)
* OR have 3+ indicators of metabolic syndrome (high triglycerides, low HDL-cholesterol, high blood pressure) plus prediabetes HbA1c.

Exclusion Criteria:

* Uncontrolled hypertension or other health issues, e.g., gastrointestinal disease
* Weight changes of \>10% of participants body weight within a 6 month period
* Pregnant or breastfeeding
* Allergy to peas, lentils, tomatoes, gluten, or latex
* HgbA1c level of \>10% at screening
* Unwillingness or inability to follow study protocol.
Prevalence of MLFA Types and MD in Egyptian Children With Erupted Canines

Descriptive observational cross sectional study Outpatient at faculty of dentistry Cairo university pediatric dentistry department clinic with midline diastema and fully erupted canines will be examined and assess type of frenal attachment to see if correlation present or not


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy children
* Egyptian children with fully erupted canines
* Patient presented for routine evaluation or treatment

Exclusion Criteria:

* Children who exhibited congenital anomalies or orofacial defects
* Children with previous trauma in frenal area which affect its morphology
* Children have previous surgical intervention in labial frenum or in the maxillary anterior region.
* Children have any syndromes or habits that affect the anterior maxillary region.
Chitosan Nano-hydroxyapatite Hydrogel in Non-Surgical Treatment of Intrabony Defect

The aim of this study was to evaluate the clinical effect of Chitosan with nano-hydroxyapatite hydrogel in the treatment of periodontal intrabony defects.

Periodontitis is a chronic inflammation of the periodontium that extends beyond the gingiva and involves the destruction of the connective tissue attachment of the teeth.

Treatment modalities of periodontitis includes local drug delivery such as chitosan which is a derivative of the exoskeleton of many arthropods including prawns, lobsters and crabs.

Chitosan has been used in guided bone regeneration, hemostasis of surgical wounds, and coating of dental implants, in reconstruction of temporomandibular joint disc and guided periodontal tissue regeneration. Moreover, chitosan has been used for preventing demineralization.

HA also called hydroxylapatite, is a naturally occurring mineral form of calcium apatite with the formula Ca5(PO4)3(OH). The OH- ion can be replaced by fluoride, and carbonate, producing fluorapatite or chlorapatite. It crystallizes in the hexagonal crystal system.

Eligibility Criteria:
Inclusion Criteria:

* Age from 25 to 55 years.
* Both sexes.
* Patients with stage II to III periodontitis with probing pocket depths ≥ 5 mm and radiographic evidence showing infrabony defect.

Exclusion Criteria:

* Patients received periodontal or antibiotic therapy within the previous 6 months preceding the study.
* Smokers.
* Pregnant and lactating females.
* Patients on medications known to affect bone turnover or with known side effects to chitosan, nano-hydroxyapatite, and collagen membrane.
Pudendal Nerve Block for Hemorrhoidectomy

Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomized to receive or not the pudendal nerve block after the spinal anesthesia.

Patients included were those undergoing Milligan-Morgan hemorrhoidectomy under spinal anaesthesia from January 2018 to December 2019. Exclusion criteria were age \< 18 years old, pregnancy and allergy to local anaesthetics. Patients meeting inclusion and exclusion criteria were randomized to undergo an ultrasound-guided pudendal nerve block. Per-protocol all patients received postoperative metronidazole 500 mg for 3 days, laxative, a basis analgesia with NSAID and opioids as needed. Postoperative pain on the visual analogue scale (VAS) at 6, 12, 24 and 48 hours, opioids needed, complications and length of hospital stay were recorded. Patients and ward personnel were not informed about the treatment arm. All Patients were further controlled 6 weeks after the intervention.

Eligibility Criteria:
Inclusion criteria:

* Patients affected by haemorrhoids (grade III and IV) and treated with Milligan-Morgan hemorrhoidectomy under spinal anaesthesia
* Signed informed consent

Exclusion criteria:

* Age \< 18 years old
* Pregnancy
* Allergy to local anaesthetics
Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity

The purpose of this research study was to determine if the activity of erythropoietin (r-HuEPO) is time dependent when given to chronic renal failure patients at three different times of day.

This phase-II crossover study was designed to test if the activity of erythropoietin is time dependent. Patients with chronic renal failure on hemodialysis requiring r-HuEPO to maintain adequate levels of hematocrit are eligible for the study. Patients were administered r-HuEPO subcutaneously three times per week, 50 U/kg, rounded to the nearest 2000 units. r-HuEPO will be administered until the hematocrit rises from the baseline level of 20-24% to the target level of 30-34%. This will be repeated three times, each at different times of day, either 0800, 1500 or 2200 hrs and the order of these will be randomly determined. Each patient will complete all three of the phases.

Eligibility Criteria:
Inclusion Criteria:

* Chronic renal failure patients requiring hemodialysis and requiring r-HuEPO to maintain adequate hematocrit levels
* Serum ferritin level \> 200 micrograms/L and transferrin saturation \> 15%
* Serum erythropoietin level less than 500 mu/ml (when off r-HuEPO)
* Prior therapy with r-HuEPO
* An adequate program of dialysis established
* Informed consent signed

Exclusion Criteria:

* Adocumented cause of anemia other than chronic renal disease
* Symptoms of unstable coronary artery disease
* Poorly controled hypertension
* Known seizure disorder
* Other active inflammatory or infective disorders
* Other disorders that may diminish the response of the bone marrow to r-HuEPO
Malnutrition in Gastroenterology Patients

Background: Malnutrition is frequently occurring in sick patients and is associated with a higher morbidity and mortality. Muscle dysfunction is a common finding in malnutrition which leads to a reduced functional status and quality of life.

Specific aims: The purpose of the study is to evaluate the effect of a three month nutritional intervention with oral supplements on nutritional status, muscle function and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Malnutrition
* Benign disease

Exclusion Criteria:

* Malignant disease
Study of OCA in Combination with BZF Evaluating Efficacy, Safety, and Tolerability in Participants with PBC

Study to evaluate the efficacy, safety, and tolerability of investigational drug obeticholic acid (OCA) in combination with the investigational drug bezafibrate (BZF) in participants with Primary Biliary Cholangitis (PBC).


Eligibility Criteria:
Inclusion Criteria:

* A definite or probable diagnosis of PBC
* Qualifying ALP and/or bilirubin liver biochemistry values
* Taking Ursodeoxycholic Acid (UDCA) for at least 12 months or no UDCA for 3 months before Day 1

Exclusion Criteria:

* History or presence of other concomitant liver diseases
* Clinical complications of PBC
* History or presence of hepatic decompensating events
* Current or history of gallbladder disease
* If female, known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
* Treatment with commercially available OCA or other farnesoid X receptor (FXR) agonists, or participation in a previous study involving OCA within 3 months before Screening.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Effect of Ruboxistaurin on Clinically Significant Macular Edema

The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or 2 diabetes
* 18 years or older
* Hemoglobin A1c (HbA1c) less than or equal to 11%
* Mild to very severe non-proliferative diabetic retinopathy in the study eye
* Clinically significant macular edema in the study eye not within 100 microns of center of macula

Exclusion Criteria:

* Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
* Glaucoma in the study eye
* Unstable cardiovascular disease
* Major surgery within past 3 months
* Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
The Efficacy and Safety of a Hybrid Hemostatic Device (ClearCoajet)

The ClearCoajet is a new hemostasis device with a hybrid function (Coagulation + Injection) and is developed to provide effective coagulation, injection, and marking around lesions without changing devices during the endoscopic procedure. In this study, the investigators examine the hemostatic effect of ClearCoajet on intraprocedural bleeding during endoscopic mucosal resection or endoscopic submucosal dissection for colorectal sessile polyps or lateral growth tumors larger than 1.5 cm. The investigators also aim to compare the delayed bleeding and recurrence rates between the ClearCoajet group and the control group.


Eligibility Criteria:
Inclusion Criteria:

* patients with colorectal sessile polyps or lateral growth tumors larger than 1.5 cm

Exclusion Criteria:

* Pedunculated polyp
* Patients with coagulopathy