cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Ranolazine in Patients With Chronic Total Occlusions of Coronary Arteries

Anti-anginal drugs relieve ischemia and symptoms by reducing myocardial oxygen demand by reducing heart rate and or contractility (beta-blockers, phenylalkylamine and benzothiazepineate classes of calcium antagonists) or vasodilatation of the venous system (fall in pre-load) and coronary vessels.

Late sodium channels remain open for longer in the presence of myocardial ischaemia. Ranolazine, a novel anti-anginal agent, acts by inhibiting the inward late inward sodium current (INaL), reducing intracellular sodium accumulation and consequently intracellular calcium overload via the sodium/calcium exchanger. It is currently thought that this reduction in intracellular calcium reduces diastolic myocardial stiffness and therefore compression of the small coronary vessels. There is considerable animal data to support this theory.

There are good theoretical reasons to postulate that patients with chronically occluded vessels may derive less benefit from conventional anti-anginal agents, particularly vasodilators. The ischemic myocardium, subtended by the occluded vessel, will already be subject to significant concentrations of paracrine vasodilators such as adenosine. Ranolazine, therefore, may on the basis of its mechanism of action, provide greater relief of ischemia in such patients than conventional anti-anginal agents.

To test this hypothesis, a randomized study comparing addition of ranolazine to addition of a minimum of 2 conventional anti-anginal agents in patients with chronic total occlusions would be required. To be sufficiently powered, this would require a significant number of patients recruited in a multi-center trial. This study is an initial pilot study with inactive placebo, not addition of a conventional anti-anginal agent, as the control using MRI imaging data as the primary end-point.

Eligibility Criteria:
Inclusion Criteria:

* Angiographically proven coronary artery disease with chronic stable angina for at least 3 months.
* Abnormal stress test (treadmill ECG, nuclear stress test, dobutamine stress echocardiogram or stress perfusion cardiac MRI)
* ≥ 1 chronically occluded coronary artery of a dominant coronary vessel or the left anterior descending artery and/or ≥ 1 occluded vein graft to chronically occluded native coronary vessel
* Subjects must be taking a minimum of 2 anti-anginal agents:

Exclusion Criteria:• Coronary revascularization in the preceding 2 months

* LVEF \< 40
* Terminal illness such as cancer
* Occluded recessive coronary vessel
* Hepatic insufficiency,
* Liver cirrhosis,
* Prolonged QT interval on ECG,
* Severe renal failure (see below), Excluding patients with CrCl \< 30
* Drugs that are strong inhibitors of CYP3A such as, ketoconazole, macrolide antibiotics and HIV protease inhibitors.
* Limit Ranolazine to 500mg BID in patients on concurrent diltiazem/verapamil
* Limit concurrent simvastatin to 20 mg/day
* Limit concurrent metformin to 1700 mg/day
* Inability to have an MRI scan/known claustrophobia
A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP

BTK participates in a variety of signal transduction of innate and adaptive immunity, and has an important role in cell proliferation, differentiation and apoptosis. The impact of BTK inhibitors on hematological malignancies and autoimmune diseases has been well studied. This project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of the selective BTK inhibitor Orelabrutinib in the management of refractory ITP.

The investigators are undertaking a prospective, open-lable, multicentre trial of 40 refractory ITP adult patients in China. Eligible participants will receive Orelabrutinib in 50 mg po. qd, every 4 weeks for one cycle and it will be given 3 cycles. For non-responders who were well tolerated at 12 weeks of follow-up, the treatment could be extended to 6 cycles. The treatment will be discontinued after 6 months without blood index reaction. In order to report the efficacy and safety of Orelabrutinib in the management of refractory ITP, platelet count, bleeding and other symptoms will be evaluated before and after treatments. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for primary immune thrombocytopenia
* To show a platelet count \< 30 \* 10\^9/L, or with bleeding manifestations, or both
* Willing and able to sign written informed consent
* Meet the diagnostic criteria of refractory ITP according to Chinese guidelines

Exclusion Criteria:

* Secondary thrombocytopenia
* severe immune-deficiency or history of primary immunodeficiency
* active or previous malignancy
* HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess)
* pregnancy or lactation
* diabetes
* hypertension
* cardiovascular diseases
* severe liver or kidney function impairment
* psychosis
* osteoporosis
* inflammatory bowel disease or gastric disease
* arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment
* an organ or haematopoietic stem-cell transplantation
* neutrophil count of less than 1500 cells per mm³; glycosylated haemoglobin less than 8%; partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN)
* clinical electrocardiogram changes
* neoplastic disease within the past 5 years
* corrected QT interval greater than 450 ms for men and greater than 470 ms for women;
* substance misuse within the previous 12 months; and those who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.
Cesarean Wound Closure: Dermabond Versus Steri Strips

The purpose of this study is to determine overall patient satisfaction with their cesarean section scar with application of Steri-strips vs. Dermabond following subcuticular skin closure of pfannenstiel incision


Eligibility Criteria:
Inclusion Criteria:

* Women age 18-45 who are undergoing planned or unscheduled cesarean section at Regional One Health
* Gestational age \> 24 weeks
* Planned Pfannenstiel incision
* Willing to consent to the study

Exclusion Criteria:

* Emergency or urgent cesarean section
* Vertical skin incision
* Intrapartum intraamniotic infection
* Diabetes
* Unwilling to consent to the study
High Dose Vitamin D Supplementation in Chronic Spontaneous Urticaria

Chronic spontaneous urticaria is an inflammatory disease which is characterized with intermittent or daily urticaria. This diseases lasts for more than 6 weeks. Several recent studies have suggested a role for vitamin D in modulation of immune system and pathogenesis of chronic urticaria.


Eligibility Criteria:
Inclusion Criteria:

* Uriticaria or angioedema daily or more than 3 days a weeks for at least 6 weeks

Exclusion Criteria:

* Physical urticaria aquired or hereditary angioedema Calcium level \> 10.3 mg/dl Glomerular filtration rate \<50 Sarcoidosis Primary hyperparathyroidism Granulomatous diseases Malignancies Pregnancy Lactation
Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis

The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or been intolerant to at least one standard approved therapy and/or have no comparable or satisfactory alternative therapy options.


Eligibility Criteria:
Key Inclusion Criteria:

* Able to provide written informed consent and commit to EAP assessments.
* ≥18 years of age.
* Able to swallow tablets.
* Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO Classification for SM
* Not receiving adequate disease control on current therapy(ies).
* Have clinically acceptable laboratory screening results.

Exclusion Criteria:

* Patients who are eligible for and/or enrolled in an on-going bezuclastinib clinical trial.
* Patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent.
* Pregnant or currently breastfeeding.
* Prior or ongoing clinically significant illness or medical or physical condition

Other protocol-defined criteria apply.
Study of Sildenafil in Patient With Heart Failure.

The purpose of this study is to determine if sildenafil (Viagra) improves exercise tolerance.

Patients will undergo an exercise stress test. One dose of Sildenafil will then be given, followed by a one hour rest period. A repeat exercise stress test will then be repeated.

Eligibility Criteria:
Inclusion Criteria:

Age 18 - 75 Ejection fraction \<35% Heart failure limited by fatigue and shortness of breath -

Exclusion Criteria:

Inability to exercise. Patients with shortness of breath while resting. Patient requiring intravenous medication. Patients taking the following medications: nitroglycerine pill/patch/paste, isordil and Imdur

-
Diagnosis of Bile Duct Strictures

The purpose of this prospective study is to compare the diagnostic utility of two techniques (brush cytology + FISH and brush cytology + free DNA analysis) in the diagnosis of biliary strictures. Histologic diagnosis (biopsies) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy. In order to do this the investigators will ask study participants to have a small volume of fluid obtained from the bile duct sent for additional testing at RedPATH. In some patients additional brushings will be obtained for FISH testing (this adds \<2 minutes to ERCP and only associated risk is increased procedure duration).

The investigators hypothesize that the use of cytology +DNA analysis has a higher sensitivity and accuracy when compared to cytology +FISH in patients with biliary strictures.

Primary aim:

To compare the sensitivity and accuracy of the two techniques (brush cytology + FISH and brush cytology + free DNA analysis). Histologic diagnosis (histology from biopsy or cytology for fine needle aspiration) in conjunction with clinical and/or imaging follow-up will serve as the gold standard for diagnosis of malignancy.

Secondary aims:

1. To evaluate the diagnostic yield of malignancy when all three techniques (cytology, FISH and DNA analysis) are used.
2. To evaluate the added value of biliary forceps biopsies, when used in conjunction with cytology, FISH and DNA analysis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients age: \> 18 years
2. Presence of a biliary stricture
3. Ability to provide written informed consent.

Exclusion Criteria:

1. Severe coagulopathy (INR \> 1.8) or thrombocytopenia (platelet count \<50,000)
2. Inability to cannulate the common bile duct
3. Presence of altered anatomy (Billroth II or Roux-en-Y reconstruction)
An Integrated Management Pathway for Complex Colorectal Polyps

The purpose of this study is to evaluate the impact of implementing an integrated clinical care pathway for the diagnosis, referral, evaluation and treatment of large complex colorectal polyps on clinical outcomes

Our project will create a system that links community hospitals and ambulatory endoscopy centers throughout the province of Ontario, directly to the expert endoscopists at our tertiary referral center, to facilitate the timely assessment of polyps based on an electronic referral containing endoscopic video recordings or high-resolution images rather than a paper report through a centralized referral pathway. This polyp adjudication will happen in a timely fashion without involving in-person patient consultation, and will streamline the management of these patients to either referral for surgery or booking for endoscopic polyp removal by therapeutic colonoscopy at our center. Specific endoscopy time slots will be reserved for these patients to ensure they have efficient access to their treatment. This system represents a new care model for managing patients with concerning pre-cancerous lesions diagnosed in disparate local hospitals through a centralized process of referral, diagnostic evaluation and treatment at an expert tertiary referral centre.

The primary aim of our study will be to track the outcomes of the new standard-of-care clinical pathway. Clinical objectives of the project include a reduction in wait times for expert assessment after diagnosis of a large or otherwise concerning polyp combined with reduced wait times for therapeutic removal of these polyps, minimizing unnecessary surgery for benign lesions, and facilitating early recommendation for surgery in those patients who truly require surgical resection. Additional objectives include the achievement of excellent rates of clinical success, complication rates similar to those reported in the literature, and high levels of satisfaction from referring doctors at participating centers. A final, major goal is to assess whether this pilot program could serve as a model to be expanded to other academic, tertiary referral centers throughout the province of Ontario.

Our primary research question seeks to compare the diagnostic accuracy of expert polyp adjudication between the different modes of referral (video clip, color photograph, faxed images) against the real-time endoscopic diagnosis during therapeutic colonoscopy and the final pathologic result. The secondary research question is to follow the clinical outcomes of all patients who undergo endoscopic mucosal resection (EMR) of a large or complex colorectal polyp to evaluate the efficacy and safety of this procedure at our expert tertiary referral center.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient 18 years or older
* Large or complex colorectal polyp found during diagnostic colonoscopy

Exclusion Criteria:

* Severe medical comorbidities that contraindicate safe endoscopy procedures
* Inability to provide informed consent
Marcaine Post-Operative Pain Study

The study examines the efficacy of Marcaine in post-operative pain reduction for patients receiving breast reduction surgery. Patients who consent will be randomized to which breast receives a Marcaine injection and the other breast will have saline injected. Pain will be assessed one time post-operatively using a 1-10 pain scale.


Eligibility Criteria:
Inclusion Criteria:

* Must be receiving bilateral breast reduction surgery

Exclusion Criteria:

* Unilateral breast reduction surgery
Comparison of Perioperative Standard Fluid Management and Goal-Directed Fluid Management

To compare the goal-directed fluid therapy based on the data obtained from the hemodynamic monitoring system, which provides continuous CO, SV and SVV measurements through arterial pressure wave with standard fluid therapy in perioperative fluid management of patients undergoing head and neck surgery.

Following the ethics committee approval and patients consent, the study was completed with a total of ASA I-III, 60 patients over the age of 18 who will undergo head and neck surgery.After randomization, patients underwent arterial cannulation. The arterial cannulas of the study group patients were integrated into the hemodynamic monitoring system with a special transducer, and their fluid management was planned to achieve a target value of 13% or less through SVV monitoring. In the control group, fluid management was set as MAP (Mean arterial pressure) 65 mmHg and above and diuresis 0.5ml/kg/hour and above. Crystalloid infusion at 7ml/kg/hour was started in both groups. When SVV value increased to 13% and over in the study group, 250 ml of crystalloid was given in the first stage, and if it continued to be 13% and over, 250 ml of colloid bolus was given. Vasoconstrictor agent was used when SVV was below 13% and MAP was below 65 mmHg. The patients in the control group were given 250 ml of crystalloid in the first stage if the MAP was below 65 mmHg, and 250 ml of colloid bolus if the hypotensive episode continued. If hypotension persisted despite these fluid boluses, a vasoconstrictor agent was used. In addition, when the diuresis of the patients was detected at 0.5mg/kg/hr or less, 250 ml of colloid bolus was administered.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteering to participate in the study
2. ASA classification 1, 2 or 3
3. The patients who will undergo head and neck surgery

Exclusion Criteria:

1. Being under the age of 18 or over the age of 80
2. Presence of serious cardiac, renal and liver pathology ( ejection fraction\< %35 and/or glomerular filtration rate\< 30ml/kg/min, kreatinin\>2,5mg/dl and/or abnormal liver function test)
3. The patients who have heart rhythm problems such as atrial fibrillation, sinus tachycardia, ventricular extrasystoles
4. The patients who have a peripheral arterial disease
5. Being a morbid obese ( BMI\>40 kg/m2)
6. the patients who may have considered difficult airway
A Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-02)

The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma. The safety of the study drug and its effect on the disease will also be studied.

Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the amount of a drug in the body at different time points.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of advanced and/or metastatic solid tumor or lymphoma that is refractory to standard therapy
* Measurable or evaluable disease
* Score of 0 to 2 on the ECOG performance scale

Exclusion Criteria:

* Concurrent serious medical illness
* Known, clinically suspected, or history of central nervous system (CNS) tumor involvement
* Active diarrhea
* Known history of coagulation disorder
* Patients requiring cytochrome P450 3A4 (CYP3A4) enzyme inducing medications
* Requirement for ketoconazole or other strong inhibitor of CYP3A4 enzymes
* Prior chemotherapy, immunotherapy, investigational agent, or other therapy used to treat the cancer within 4 weeks (6 weeks for prior treatment with mitomycin C or nitrosoureas) prior to the scheduled administration of EZN-2208.
The Bilirubin Levels in Cerebrospinal Fluid of Spontaneous Subarachnoid Hemorrhage Patients

According to Morgan et. al. (J Neurosurg 101:1026-1029, 2004): bilirubin as a cerebrospinal fluid marker of sentinel subarachnoid hemorrhage: a preliminary report in pigs, we're going to test the hypothesis in the cerebrospinal fluid of spontaneous subarachnoid hemorrhage patients.

According to Morgan et. al. (J Neurosurg 101:1026-1029, 2004): bilirubin as a cerebrospinal fluid marker of sentinel subarachnoid hemorrhage: a preliminary report in pigs, we're going to test the hypothesis in the cerebrospinal fluid of spontaneous subarachnoid hemorrhage patients. We'll collect the serial cerebrospinal fluid in 15-20 spontaneous subarachnoid hemorrhage patients to see the time sequence of changes in bilirubin levels.

Eligibility Criteria:
Inclusion Criteria:

* spontaneous subarachnoid hemorrhage in less than three days

Exclusion Criteria:

* spontaneous subarachnoid hemorrhage more than three days
The Effects of Co-admin of Colesevelam and Sitagliptin on Glucose Metabolism in Subjects With Type 2 Diabetes Mellitus

This study will assess the effects of colesevelam, alone or in combination with sitagliptin, on glucose metabolism in subjects with T2DM inadequately controlled by diet and exercise

The hypothesis is that co-administrationof colesevelam plus sitagliptin results in a greater reduction in HbA1c compared to colesevelam HCl treatment by

1. improving the effects of colesevelam on fasting glucose metabolism
2. improving the effects of colsevelam on postprandial glucose metabolism

Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Females of childbearing potential are on approved birth control method
* Negative pregnancy testing for females of childbearing potential
* Previously diagnosed or newly diagnosed with T2DM drug naïve subjects
* HbA1c: 6.7-10%
* Age 18 - 80 years
* BMI ≥ 18.5 kg/m2 and ≤ 40 kg/m2
* Fasting serum glucose \< 300 mg/dL
* Normal liver function, normal thyroid function, no history of liver, biliary or intestinal disease
* Normal TSH
* On stable diet and exercise routine for at least 4 weeks prior to screening
* Has had a stable weight (+/-5%) for ≥3 months before screening

Exclusion Criteria:

* A history of type 1 diabetes mellitus or history of diabetic ketoacidosis
* History of chronic (required daily for \> 2 months) use of insulin therapy
* Treatment with blood pressure lowering therapy that has not been stable for three months before screening
* Treatment with lipid lowering medication other than statins
* Treatment with statins that has not been stable for three months before screening
* Treatment with a DPP-4 inhibitor or and GLP1 agonists at any time
* Treatment with a thiazolidinedione (TZD) within the last 6 months of screening
* History of an allergic or toxic reaction to sitagliptin or colesevelam
* History of dysphagia, swallowing disorders, bowel obstruction, intestinal motility disorder, and gastrointestinal disorders
* History of major gastrointestinal surgery
* History of kidney problems
* Fasting plasma triglycerides \> 300 mg/dL
* Serum LDL-C \<60 mg/dL
* Positive toxicology test
* Known hypersensitivity to colesevelam HCl or sitagliptin.
* Any contraindications to a study medication (colesevelam HCl or sitagliptin).
A Trial of Epilation Verses Surgery for Minor Trichiasis

Trachoma is the leading infectious cause of blindness worldwide. Recurrent infection by Chlamydia trachomatis causes a gradual scarring process of the inner surface of the eyelid (conjunctiva) leading to in-turning of the eyelids (entropion) and lashes touching the eye (trichiasis). The rate of progression and the severity of disease are variable. Some people develop severe disease with extensive entropion and trichiasis, whilst others have a mild problem with only a few lashes touching the eye, which does not progress.

In more advanced cases there is a broad consensus that the entropion / trichiasis should be corrected by surgery. In mild cases (minor trichiasis: 1-5 lashes touching the eye) the optimal treatment is uncertain. Some advocate early surgery to turn the eyelid out for any individual with one or more lashes touching any part of the eye. Others consider this to be too early for surgical intervention, as surgery can have a high recurrence rate and complications can arise. Instead, they recommend that minor trichiasis can be managed by epilation (pulling out lashes with forceps). In many endemic regions the uptake of surgery is low, with many patients preferring to epilate for mild disease.

The primary purpose of this study is to compare the outcome of immediate surgery to regular epilation for the management of minor trichiasis. The epilation would be done by a person with good eyesight using proper epilation forceps.


Eligibility Criteria:
Inclusion Criteria:

* Minor trichiasis: 1 - 5 lashes touching the eye

Exclusion Criteria:

* Previous eyelid surgery.
* Patients with evidence of corneal damage (will be offered surgery).