cyrilzakka/clinical-trials huggingface dataset:
Improving Complete Endoscopic Mucosal Resection (EMR) of Colorectal Neoplasia

The investigators seek to compare two techniques of removing pre-cancerous lesions from the colon. The investigators also will compare two solutions used during the procedure to determine if either solution allows for an improved removal of the tumors.

The primary aim of the study is to compare the efficacy, efficiency and safety of two types of snares used in Endoscopic Mucosal Resection (EMR), a combined needle and snare unit (ISnare, US Endoscopy) versus an oval braided snare with spiral wire (Snaremaster, Olympus). The secondary aim is to explore whether EMR efficacy and efficiency is depended upon the injection solution used, saline versus Gonak (a solution containing HPMC, saline, and epinephrine) for EMR.

Eligibility Criteria:
Inclusion Criteria:

* Sessile colorectal polyp
* laterally spreading lesions as defined by Paris Classification type II and \> 1 cm or greater

Exclusion Criteria:

* Those with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma
* Inflammatory bowel disease patients
* Coagulopathy ( INR\> 1.5) that cannot be corrected
Menorrhagia Study in Women With Treatment-resistant Menorrhagia

The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion Criteria:

* Organic causes of menorrhagia
* Current hormone treatment
Efficacy of Intravenous Lidocaine on Postoperative Pain and Recovery in Patients Undergoing Hepatectomy

Patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or the placebo group.

In the lidocaine group, at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery. In the placebo group, the same volume of normal saline will be administered during anesthesia.

Patients who meet the enrollment criteria will be randomized 1:1 to either the lidocaine or the placebo group.

In the lidocaine group, at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery.

Blood samples will be drawn immediately after the bolus infusion of lidocaine, at the end of the surgery, and 24 hours after surgery to measure plasma lidocaine concentrations. Blood samples will also be collected 24 hours after surgery for subsequent measurement of IL-6, and tumor necrosis factor-α (TNF-α). The obtained samples will be labeled, centrifuged, frozen, and stored locally at -80° for subsequent testing.

Postoperative pain management during the first 72 postoperative hours will involve the use of a PCIA device, which will contain lidocaine 30mg/kg, sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline. In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 ml. All the background infusions of PCIA will set at 2 ml/h, the bolus volume of each PCIA press is 2 ml and the lockout interval is 15 min.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80 years old
* American Society of Anesthesiologists(ASA) Ⅰ～III
* patients scheduled for elective hepatectomy

Exclusion Criteria:

• body weight \< 40 kg or \>100 kg; metastases occurring in other distant organs; severe hepatic insufficiency (aspartate aminotransferase or alanine transaminase or bilirubin \> 2.5 times the upper limit of normal), renal impairment (creatinine clearance \< 60 ml/min); cardiac rhythm disorders or systolic heart failure (second-and third-degree heart block, ejection fraction \< 50%); with allergies to any of the trial drugs; inability to comprehend numeric rating scale.
Epidemiological Characteristics and Prediction System of Acute Respiratory Distress Syndrome

This project intends to adopt the multicenter prospective real-world study method to conduct a preliminary study on the incidence, grading, risk factors, respiratory support strategies, in-hospital mortality, 3-month mortality, 6-month mortality, 1-year mortality, quality of life, lung function and limb function recovery, cognitive function, return to work and other conditions of ARDS patients in RICU. By collecting 1,000 patients, a clinical database related to ARDS in China was established to provide essential data and ideas for promoting standardized diagnosis and treatment technology for ARDS patients and further clinical intervention research. At the same time, ARDS biobank was established in China-Japan Hospital and Xiangya Hospital to realize the integration of clinical data and sample resources, and the prediction model of ARDS survival and complications of tuberculosis clinical data and biological samples was established by using big data and AI technology.


Eligibility Criteria:
Inclusion Criteria:

* New or worsening respiratory symptoms less than 7 days after the acute blow.
* CT/X-ray: Double lung infiltration that cannot be fully explained by pleural effusion, lobar/whole atelectasis, and nodule.
* Respiratory failure that cannot be explained by heart failure or fluid overload
* After 15min assisted ventilation (PEEP or CPAP ≥ 5cmH2O) or HFNC with flow≥30L/min, PaO2/FiO2≤300mmHg
* Classification of ARDS: mild (200mmHg \< PaO2/FIO2 ≤ 300mmHg), moderate (100mmHg \< PaO2/FIO2 ≤ 200mmHg), and severe (PaO2/FIO2 ≤ 100mmHg) and 4 ancillary variables for severe ARDS

Exclusion Criteria:

* younger than 18 years old
* Patients or family members refused to participate in the study
Subclinical COronary Atheroscleorosis Updated With Coronary cT Angiography (SCOUT Study)

The purpose of this study is to validate the usefulness of 64-slice multi-detecter computeted tomography as a screening tool in asymptomatic population.

A large proportion of patients with sudden cardiac death or nonfatal myocardial infarction (MI) had no prior symptom, which emphasizes the importance of early detection and treatment of the underlying subclinical coronary atherosclerosis before they happen. However, there are no powerful screening methods to detect subclinical coronary atherosclerosis until recently. Traditional CAD risk factors, treadmill exercise test, and EBCT are known to have limited power to detect subclinical coronary atherosclerosis and predict future cardiac events.

Coronary CT angiography (CTA) depicting detailed coronary artery anatomy in a noninvasive fashion would seem to be already one of the mainstays of diagnostic procedure in symptomatic population. Instead of the probability of significant stenosis, CTA could provide information about the location, burden and characteristics of atherosclerotic plaque per se, which might give additional insight to stratify the risk of future cardiac events and therapy.

In this study, we will evaluate the prevalence and characteristics of subclinical coronary atherosclerosis on CTA and its impact on the management in asymptomatic population. And then, we will develop standardized protocol for the management of subclinical coronary atherosclerosis, and follow for adverse cardiac events.

In phase I study, we will enroll subjects who had undergone CTA and analyze the characteristics of plaques on CTA. Also, we will evaluate the impact of CTA by comparing the performance of secondary test with those who had not undergone CTA evaluation.

In phase II study, we will recruit subjects who had significant coronary stenosis on CTA. If the patients had significant stenosis, they will undergo coronary angiography to confirm the severity of stenosis. If they had coronary artery stenosis more than 75%, they will receive percutaneous coronary intervention with drug-eluting stent (DES). If they had intermediate lesion, their treatment option will be judged by the results of fractional flow reserve test. If they had coronary lesion less than 50%, they will be treated only by medication.

When the patients are eligible for study, investigators will give information about the study and obtain written consent. The presence of chest pain symptom will be screened with Rose questionnaire. Medical history and physical examination will be performed, and baseline laboratory work-up will be performed.

Following above treatment guidelines, all patients will be followed for adverse cardiac events for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic subjects
* 20-75 years
* subjects who had undergone spiral coronary CT angiography for health check-up

Exclusion Criteria:

* typical or atypical chest pain
* serious comorbid conditions(i.e. malignancy)
Pre-emptive Sciatic Bloc to Prevent Lower Limb Phantom Pain

Phantom limb pain is a complication of amputation. Although pre-empitve epidural analgesia was once thought to prevent such a com plication, recent studies did not demonstrate this. Peripheral blocks are more powerful then epidurals, and can even influence somatotropic representation in the brain. This a prospective case series in which the investigators hope to show a decrease, against historical control, of the incidence of post-operative amputation lower limb phantom pain. The investigators established the block at least 24 hours pre-operative and continue it for at least 2 days. Patient are followed daily for the 1st 3 days and then up to 3 month for the incidence of phantom limb pain. The investigators hope to recruit 30 patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for lower limb amputation

Exclusion Criteria:

* Inability to consent
* Contraindication to peripheral nerve block
* Inability to perform the block
* Inadequate time frame (less than 24 hours prior to surgery)
The Effect of Pre-operative Use of Finasteride Versus Cyproterone Acetate on Blood Loss With Transurethral Resection of Prostate

Perioperative bleeding is the most common complication related to transurethral resection of prostate, the aim of the study is to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP

This prospective randomized controlled study to compare the effect of pre-operative use of finasteride versus Cyproterone acetate on blood loss with mono polar TURP

Eligibility Criteria:
Inclusion Criteria:

* Patients with benign prostatic hyperplasia with prostate size (60-100) grams
* Lower urinary tract symptoms (LUTS) not responding to medical treatment
* Recurrent prostatic bleeding
* Recurrent acute urinary retention
* Chronic urinary retention

Exclusion Criteria:

* Patients with coagulation disorders
* Previous prostatic surgery
* Previous finasteride administration
* Bladder pathology (urinary bladder stones - bladder mass)
* Suspected or proved cancer prostate
* Hepatic or renal impairment
* Patients unfit for operation eg. Decompensated heart failure, poor chest condition
Implementation of a Personalized Medicine (Pharmacogenomics) Service in a Community Pharmacy

The purpose of this study is to determine the feasibility of pharmacogenomics testing in a community pharmacy using clopidogrel as an example. The investigators hypothesize that this testing is feasible in this setting.

To determine if the study is feasible, we will examine the change in patient perception of pharmacogenomics testing (before and after the study), the percentage of patients interested in this service, the response rate of providers to pharmacist recommendations, the pharmacist time requirement, and reimbursement rate for pharmacist services.

Eligibility Criteria:
Inclusion Criteria:

* Prescribed clopidogrel (Plavix) by their prescriber
* Aged 18 or older
* Currently on clopidogrel therapy for one of the following indicated uses: post-ACS, Recent PCI with stenting, History of TIA or stroke

Exclusion Criteria:

* Are unable to complete study materials (surveys) with or without assistance, including non-English speaking patients
* Are taking clopidogrel for a reason other than stated in inclusion criteria
* Are pregnant or nursing
* Have an allergy to aspirin
Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring

Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?

traumatic brain injury intracranial hypertension 0,4 g/ kg vs 0,8 g/ kg (randomized) on 20 minutes monitoring: ICP, transcranial doppler, brain pO2, MAP, HR, diuresis, biology duration: 2 hours

Eligibility Criteria:
Inclusion Criteria:

* adults
* severe traumatic brain injury
* intracranial hypertension requiring mannitol administration

Exclusion Criteria:

* impeding neurosurgery
* hemodynamic or respiratory severe failure
Safety and Efficacy of Indacaterol Once Daily Versus Salmeterol Twice Daily in Chronic Obstructive Pulmonary Disease (COPD)

This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 40 years
* Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate to severe as classified by the GOLD Guidelines, 2007) and:

  * Smoking history of at least 10 pack years
  * Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value at screening
  * Post-bronchodilator FEV1/FVC (forced vital capacity) \< 70% at screening

Exclusion Criteria:

* Patients who have received systemic corticosteroids for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period
* Patients requiring long-term oxygen therapy (\> 15 h a day) for chronic hypoxemia
* Patients who have had a respiratory tract infection within 6 weeks prior to screening
* Patients with concomitant pulmonary disease
* Patients with a history of asthma
* Patients with diabetes Type I or uncontrolled diabetes Type II
* Any patient with lung cancer or a history of lung cancer
* Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time
* Patients with a history of long QT syndrome or whose QTc interval (Fridericia's) measured at screening is prolonged
* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period
* Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements

Other protocol-defined inclusion/exclusion criteria applied to the study.
Effects of Single-task Versus Dual-task Training on balancePERFORMANCE

Background: Impairment in the control of balance is a common problem among elderly patients especially whom with osteoarthritis (OA).

Aim: The aim of this study was to compare the effects of single-task and dual-task training on balance performance in the elderly osteoarthritic patients with balance impairment.

Fifty elderly osteoarthritic patients with balance impairment were included into this study. Patients were randomly assigned to single task balance training (Group 1) or dual-task balance training (Group 2) groups. Balance activities were given to both groups for 3 times a week for 4 weeks. Patients in group 2 also performed cognitive tasks simultaneously with these exercises. Patients were evaluated with Berg balance scale (BBS), kinesthetic ability trainer (KAT 2000) static and dynamic scores, timed up and go test (TUTG) and walking speed for single and dual tasks, number of stopping and Activities Specific Balance Confidence (ABC) Scale at the baseline and at the end of 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* included age ≥65, able to walk 10 m, no neurological or musculoskeletal diagnosis, met the criteria of balance impairment, and scored \>19 on the mini mental state examination.

Exclusion Criteria:

* neurologic or musculoskeletal diagnosis such as stroke, orthopedic involvement, significant visual and auditory impairments, severe vitamin B12 deficiency and sedative drug use.
Microneedling and Latanoprost in Acrofacial Vitiligo

To compare efficacy of topical latanoprost preceded by microneedling versus topical latanoprost alone in treatment of acrofacial vitiligo.

patients meeting inclusion and exclusion criteria presented to Dermatology Outpatient Clinic, Sohag University Hospital will be enrolled in the study after obtaining a written consent from them. Full history will be obtained and meticulous examination will be carried out. Patients will be randomly divided into 2 groups, one group will receive topical latanoprost with microneedling, and the other one will receive topical latabnoprost alone.

Eligibility Criteria:
Inclusion Criteria:

- Acrofacial stable vitiligo for 6 months duration (without new lesions appearance or change in size of the existing lesions).

Exclusion Criteria:

* History of scar formation.
* Patients with systemic diseases (diabetes, bleeding disorders, chronic renal diseases, chronic liver diseases, asthma and hypertension).
* Patients who are receiving chemotherapy or radiotherapy.
* Pregnant and lactating females.
Upper Extremity Versus Lower Extremity Accessory Access Sites During Transcatheter Aortic Valve Implantation

The goal of this prospective, multicenter, investigator-initiated, randomized clinical trial is to assess the safety and efficacy of a 'minimally invasive, upper extremity' approach versus the standard 'lower extremity' approach for accessory access sites in patients undergoing a transcatheter aortic valve implantation.

The main questions it aims to answer are whether a 'minimally invasive, upper extremity' approach as compared with the standard 'lower extremity' approach:

* Is associated with less clinically relevant access site-related bleeding complications.
* Is associated with a shorter time to mobilization after TAVI.
* Is associated with a shorter duration of hospitalization.
* Has the same early safety outcomes at 30 days post-TAVI.

Participants will be subject to the usual care surrounding a TAVI procedure but will also will be asked to fill out two questionnaires before and after TAVI:

* Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH)
* Lower Extremity Functional Scale (LEFS)

Researchers will compare the minimally invasive, upper extremity group with the standard lower extremity to see if there are difference regarding the posed questions.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be \> 18 years old.
* Written informed consent is obtained from all patients.
* Planned for transfemoral TAVI procedure.

Exclusion Criteria:

* Inability to obtain informed consent.
* Contra-indication for brachial or femoral vein access (temporary pacemaker access site).
* Contra-indication for radial or femoral artery access (diagnostic access site).
* Use of a cerebral embolic protection device (CEPD) if this requires an additional (arterial) access site.
The Purpose of This Study is to Determine if Tetrodotoxin (TTX) is Effective in the Treatment of Pain Resulting From Chemotherapy Treatment

Chemotherapy-induced peripheral neuropathy (CIPN) is a major dose-limiting side effect of many chemotherapeutic agents including vincristine, paclitaxel, cisplatin, oxaliplatin, bortezomib and ixabepilone. Chemotherapy-induced peripheral neuropathy commonly occurs in greater than 40% of patients. To improve the peripheral neuropathy, the chemotherapy dosing is often either decreased or discontinued potentially affecting tumor responsiveness, prognosis, and survival.

There is an unmet medical need for treatment of cancer patients with chemotherapy induced neuropathic pain (CINP) and the proposed study will investigate the efficacy and safety of multiple dose levels of tetrodotoxin (TTX) versus placebo in moderate to severe neuropathic pain caused by chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* If female, not of childbearing potential.
* Patients with documented neuropathic pain
* Cancer Patients who have completed a chemotherapy regimen which included taxanes or platinums (or both) and have no evidence actively progressive disease. Concurrent hormonal therapies are allowed
* Patients with stable moderate to severe neuropathic pain
* Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Patients who are able to complete the study-related questionnaires independently in either English or Spanish.

Exclusion Criteria:

* History of peripheral neuropathy attributed to any cause other than chemotherapy.
* Patients receiving any concurrent agents known to cause peripheral neuropathy within 30 days of Randomization.
* Current use of other therapy (ies), including "alternative" therapies, for treatment of peripheral neuropathy within 30 days of Randomization (with the exception of protocol allowed concurrent medications).
* Patients who used controlled release opioids within seven days of baseline period or who expect to use controlled release opioids at any time from baseline to end of study.
* Patients with abnormal kidney function.
* Patients with bone metastases.
* Patients scheduled for treatment for their cancer with chemotherapy or radiotherapy between screening and the end of study visit.
* Current use of lidocaine and other types of antiarrhythmic drugs within 30 days of Randomization.
* Current use of scopolamine and acetylcholinesterase-inhibiting drugs such as physostigmine within 30 days of Randomization.
* Current cause of Chemotherapy Induced Neuropathic Pain attributed to Velcade (Bortezomib) or vinca alkaloids or analogues such as vincristine, vinblasine, vinorelbine and vindesine.
* Current use of tricyclic antidepressant medication, anticonvulsants and monoamine oxidase inhibitors.
* Patients with current uncontrolled asthma or lung disease.
* Patients with significant heart disease.
* Use of an investigational agent within 30 days prior to screening or is scheduled to receive an investigational drug other than TTX during the course of the study.
* Females who are pregnant or nursing
Fast Track Admittance of Hip Fracture Patients

The study examines time spent in the emergency room on admission of patients with hip fracture in a cohort with a traditional setup compared with a prospective cohort with a fast track admission schedule including nurse initiation of treatmnet, standardized analgesia, fluid and oxygen therapy and standardized logistics for x-ray and admission procedures.


Eligibility Criteria:
Inclusion Criteria:

* Admission with a primary hip fracture

Exclusion Criteria:

* None