cyrilzakka/clinical-trials huggingface dataset:
Effects of Ergocalciferol on Erythropoetin Stimulating Agent Dose

Hypothesis: The supplementation of Ergocalciferol (Vitamin D2) to those with Vitamin D deficiency in the Chronic Kidney Disease population requiring recombinant human erythropoietin for the treatment of anemia related to kidney disease will reduce the dose of erythropoietin required to maintain a nonanemic state.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease
* Age: \>18yo
* Stable Hemoglobin (Hgb) for 1 month on stable dose of erythropoietin for 1 month (defined as erythropoietin dose within 15% of previous months erythropoietin dose)
* Unchanged maintenance oral or intravenous (IV) iron therapy for 1 month
* Serum 25-hydroxy Vitamin D levels \< 30 ng/mL
* History of 25-hydroxy Vitamin D levels \< 30 ng/mL currently on ergocalciferol replacement

Exclusion Criteria:

* On hemodialysis
* Chronic kidney disease 5
* Hypercalcemic (Calcium level \> 11mg/dL)
* Pregnant female
* Iron deficient (iron saturation \< 20%, Ferritin \< 100ng/mL)
* Presence of active malignancy
* Presence of active infections
* Presence of active inflammatory properties
* Presence of blood dyscrasias
* Active bleeding or bleeding within the past 3 months (other than menses)
* B12 deficiency
* Folate deficiency
* Blood transfusion during participation
* Parathyroid levels exceeding the expected levels allowed for the stage of a subjects Chronic kidney disease (Target Parathyroid in: Chronic kidney disease 3 35-70 pg/mL, Chronic kidney disease 4 70-110 pg/mL)
Determination of the UL of Leucine in Healthy Elderly Men

Amino acid are the building blocks of the body's protein. Some amino acids, including leucine, cannot be made in the body and must be obtained from diet, these are called essential. With increase in age the body's muscle mass decrease and studies have suggested that dietary supplementation of leucine may have potential health benefits in elderly in regards to prevention of age related loss of lean muscle mass, and thus may help improve the quality of life in elderly.

Currently, a safe upper dietary intake level of leucine has not been established for healthy elderly. Prior to exploring whether leucine supplementation will prevent or decrease loss of lean muscle mass in elderly we propose to identify the upper intake of leucine in healthy elderly.

The purpose of this study is to determine the tolerable upper intake level (UL) of leucine in healthy elderly men (70 - 75 yrs)

The investigators hypothesize that with a careful graded stepwise increase in leucine intake in elderly men, above the Estimated Average Requirement (EAR - 50 mg/kg/d), the body's ability to oxidize/dispose of excess amino acids will reach a maximum. With increased leucine intakes we hypothesize an increase in plasma ammonia concentrations and increases in plasma leucine and urinary leucine excretion.


Eligibility Criteria:
Inclusion Criteria:

* Men 70 - 75 years of age
* Free of chronic diseases including; sarcopenia, heart disease, kidney disorders, liver disease, chronic high blood pressure and or diabetes.
* Free of any cognitive disorders
* Men not enrolled in any other research studies
* Men who are not claustrophobic

Exclusion Criteria:

* Men not within the age 70 -75 years
* Men diagnosed with a chronic diseases including; sarcopenia, heart disease, kidney disorders, liver disease, chronic high blood pressure and/or diabetes
* Men allergic to milk, eggs and egg protein
* Men who are claustrophobic
* Men who are currently enrolled in other research studies
Pioglitazone in Psoriasis- A Clinical and Molecular Study.

The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in terms of improvement of both skin and systemic manifestations of psoriasis.

The investigators assume that pioglitazone (one of thiazolidinediones readily available in Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in addition to improving the insulin resistance in peripheral tissues observed in many psoriatic patients and causing metabolic syndrome. This will allow to give a safer therapy than the available ones for psoriasis and to treat the patient in a more global perspective.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and less than 65 years.
* Plaque psoriasis vulgaris ≥ 10% (apart from palmoplantar psoriasis which will be included).

Exclusion Criteria:

* Age less than 18 years and more than 65 years
* Mild psoriasis less than 10% body surface area
* Erythrodermic or pustular psoriasis
* Liver disease, cardiac disease (suspected from history or ECG), or any other major medical disorder detected by history.
* Pregnant and lactating females.
Improving Diabetes Care Through Effective Personalized Patient Portal Interactions

Patient-facing eHealth technologies, such as online patient portals, connect patients with the healthcare system, help them access their health information, and support self-management of health conditions. This study tested an intervention to improve adoption and use of the My HealtheVet patient portal for diabetes management.

The goal of this small scale study is to test the feasibility of engaging Veterans in a supported adoption intervention to promote effective patient portal use in a sample of Veterans with uncontrolled Type II diabetes.

Participants were eligible for recruitment if they were Veterans age 18-85 who were actively receiving care at one of the study sites (as determined by having an upcoming scheduled appointment), had uncontrolled glucose (HbA1c \>= 8.5%), and had either never used the VA patient portal or were inactive registrants who have not used the patient portal in the past 12 months. Participants who met these conditions and did not opt out of the study were randomized to one of four arms: 1) Encouragement I (brochure + mailed training guide), 2) Encouragement II (brochure + mailed training guide + invitation to group training), 3) Encouragement III (brochure + mailed training guide + invitation to group and one-on-one training), and 4) Comparison (standard patient portal enrollment brochure only). All arms received the standard My HealtheVet patient portal enrollment brochure along with an invitation to participate in the study. Those randomized to any of the Encouragement Arms received a mailed training guide. The My HealtheVet Training Guide for Veterans Living with Diabetes was designed in conjunction with Veteran co-investigators based on feedback from patients living with diabetes who were My HealtheVet users. It provided step by step guidance on how to use the features Veterans living with diabetes find most helpful with specific examples of use for diabetes self-management. Those in Encouragement Arm II were also invited to attend one of several group training sessions. Those in Encouragement III were invited to schedule a one-on one session to learn how to use the patient portal. Those in the comparison condition were asked during their interview if they would like a Training Guide mailed to them at the end of the trial, and those interested were mailed a Training Guide.

Eligibility Criteria:
Inclusion Criteria:

* Veterans
* Hemoglobin A1c result \>=8.5% at most recent lab test prior to recruitment
* Non use of the VA patient portal, defined by not being registered or registered with no activity in 12 months
* Currently being seen at one of the sites participating in the study (upcoming appointment scheduled)

Exclusion Criteria:

* Non-Veterans
* Controlled hemoglobin A1c levels (A1c\<8.5%) at most recent lab test prior to recruitment
* Recent use of the patient portal
Satiety and Alcohol Challenge

The goal of this pilot study is to identify the role of satiety on responses to alcohol drinking using human subject laboratory methods. Satiety will be manipulated over two sessions using a dietary supplement (fiber+green tea) or a calorically matched placebo. Responses to an acute alcohol challenge are measured.

Participants will receive a beverage containing either a dietary supplement (10g Fibersol®-2 mixed with water and aspartame sweetener for taste + 725mg decaffeinated green tea extract capsule) or a calorically matched placebo supplement (Aspartame sweetener mixed with water + aspartame capsule) counterbalanced at two separate visits. Forty-five minutes after the dietary supplement, a priming drink (calculated to achieve 30mg% Blood Alcohol Concentration; BAC) is administered. Response to alcohol is measured using standardized questionnaires and a cognitive task. Then over a 2-hour period, additional mini-drinks are administered. Responses to standardized questionnaires are collected after each drink.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-45
* Meeting NIAAA criteria for current at-risk drinking (i.e., \>7/14 drinks in one week for women/men, with at least one episodes of 4+/5+ drinks in the past 30 days)
* Willingness to complete laboratory sessions involving blood draws and alcohol administration
* Ability to communicate and read in English
* Body mass index (BMI) of 21 - 30 kg/m\^2

Exclusion Criteria:

* Meets past-year criteria for severe Alcohol Use Disorder (\>7 of 11 symptoms endorsed) or AUDIT score of 20+
* Meeting past-year criteria for a substance use disorder (with the exception of alcohol, tobacco or mild cannabis use disorder)
* Current engagement in alcohol treatments, or currently engaged in intentional efforts to quit alcohol use
* Current use of weight control medications
* Lifetime diagnosis of severe mental illness (including schizophrenia and bipolar disorder)
* History of suicide attempt, or psychiatric hospitalization in the last 6 months
* History of diabetes
* Medical conditions or medications for which alcohol is contraindicated
* Pregnant, nursing, or trying to become pregnant
* Plans to travel during the duration of study participation
Anorectal Application of 5% Lidocaine Cream Reduces Pain Prior to Periprostatic Nerve Block During Transrectal Ultrasound Guided Biopsy

Transrectal ultrasound guided prostate biopsy is performed with a periprostatic nerve block to the neurovascular bundle bilaterally. This does not reduce the pain due to probe insertion and manipulation prior to nerve blockage.

Our study goal is to assess whether topical analgesia would reduce pain during the early stages of the procedure.

Prospective, randomized controlled study. Patients signed an informed consent form. Exclusion criteria were Lidocaine allergy or pre-planned general anesthesia.

Patients were randomized into 6 groups: (1) nerve block with 5 ml 1% lidocaine for each neurovascular bundle + perianal topical application of 10 ml 5% lidocaine cream; (2) as in (1) plus application of 10 ml 5% lidocaine cream evenly on rectal walls. For each approach exposure times of 5, 10 and 20 minutes were allowed, all together 6 groups plus a control group of patients who received periprostatic nerve block only. A 0-10 Visual analogue scale (VAS) was filled by the patients at 5 time points: immediately after probe insertion, during probe manipulation and prostate assessment, immediately following neurovascular bundle nerve blockage, after prostate biopsies and a global pain estimation of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Males referred to TRUSGBx due to elevated prostate specific antigen (PSA)
* Abnormal findings on digital rectal examination (DRE)
* Repeat biopsies as part of Active Surveillance (AS)
* Continuously elevated PSA levels despite prior negative for malignancy biopsies
* Previous histological findings of significant HGPIN were enrolled

Exclusion Criteria:

* Known sensitivity to Lidocaine
* Pre-planned biopsy under general anesthesia
Effects of Phrenic Nerve Stimulation During Swallowing : Experimental Model of Aspiration

the purpose of this study is to compare the oesophageal depression induced by bilateral phrenic nerve stimulation during swallowing in patients with neurological laryngeal aspiration

phrenic nerve stimulation during swallowing

Eligibility Criteria:
Inclusion Criteria:

stroke with aspiration

Exclusion Criteria:

obstructive rhinitis bronchial obstruction pace maker phrenic nerve paralysis
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia

This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Female patients, 18 years and older
* Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia; for at least 12 weeks, not necessarily consecutive, during the previous 12 months.

Exclusion Criteria:

* Abnormal esophago-gastro-duodenoscopy (EGD) endoscopy findings such as any esophageal mucosal break, gastric erosions, gastric ulcers and/or duodenal ulcers/erosions on an EDG exam performed with 12 weeks prior to baseline.
* Current or history of erosive esophagitis confirmed by EGD
* Heartburn occurring 3 or more days a week.

Other protocol-defined inclusion/exclusion criteria may apply
Impact of Prehabilitation in Oncology Via Exercise- Esophageal (IMPROVE-Esophageal)

The goal of this study is to (1) determine the feasibility of a prehabilitation exercise program (exercise before a medical treatment) in adults with esophageal cancer before surgery (esophagectomy). The pre-surgery exercise program will include resistance and aerobic training during the weeks before surgery. We will also assess pre-surgical care needs in adults with esophageal cancer. Researchers will compare the exercise intervention to usual care- which is standard medical care and post-surgery surveillance/follow-up to understand the impact of exercise before surgery. We will follow-up with participants before surgery, and after surgery at 2 weeks, 6 weeks, and 4-months at appointments that coincide with clinical follow-ups.

The main questions of this trials are:

* Is exercise before surgery for esophageal cancer feasible and acceptable to patients?
* How does exercise before surgery change physical function and psychosocial health?
* What are important pre-surgical needs for adults with esophageal cancer?


Eligibility Criteria:
Inclusion Criteria:

* Men and women, age ≥ 18 years old
* Diagnosed with esophageal cancer
* Identified as esophagectomy surgery candidates at Hillman Cancer Center or UPMC Shadyside
* ≥ 2 weeks until scheduled esophagectomy
* Currently completing, or completed Neoadjuvant chemotherapy
* ECOG Performance Status Scale score of ≤ 2
* Ability to provide written informed consent
* Ability to understand, speak, and read English.

Exclusion Criteria:

* Evidence in the medical record of an absolute contraindication for exercise (e.g., Heart insufficiency \> NYHA III or uncertain arrhythmia; uncontrolled hypertension; reduced standing or walking ability)
* Any other comorbidities or musculoskeletal complications that preclude participation in the exercise programs as deemed by the exercise interventionist
* Receiving non-esophagectomy related chemotherapy and/or radiotherapy
* Active infections, hemorrhages, and cytopenias that could place surgical patients at risk for further adverse events, deemed by the exercise interventionist, physician, and/or nurse
Pre-operative Antihypertension Strategies-Carotid Artery Stenting

Carotid artery stenting (CAS) is one of major treatments in prevention of ischemic stroke. Because of sinus reflex due to stenting and balloon dilatation, persistent post-surgery hypotension is a common perioperative event. Persistent hypotension can lead to perioperative adverse events like ischemic stroke, myocardial infraction, renal failure and death; or more usually, it prolongs length of stay and hospital expenses. Renin-angiotensin-aldosterone inhibitor (RASI) could inhibit the release of catecholamine and may lead to higher rate of persistent hypotension after CAS compared to other hypertensives.Thus, the investigators aim to investigate the effect of pre-operation antihypertensive drugs on persistent hypotension after stenting, and followed burden in carotid artery stenting comorbid with hypertension patients.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18
* have a history of TIA or nondisabling ischemic stroke within the past 6 months (symptomatic) with ipsilateral initial part of EICA stenosis ≥ 50 % or asymptomatic with initial part of EICA stenosis ≥ 70%, and the cause of stenosis was atherosclerosis
* have hypertension requiring hypertensives
* modified Rankin scale (mRS) before stenting \< 3

Exclusion Criteria:

* with ipsilateral tandem stenosis
* with history of operation in contralateral carotid artery, like stenting, endarterectomy and bypass.
* requiring operation in contralateral carotid artery in the same admission.
* requiring general anesthesia in the same operation (stenting)
* with contraindication to carotid stenting, such as Inability to tolerate surgery due to organ dysfunction, cerebral aneurism, cerebral hemorrhage in 3 months, myocardial infraction or large-area cerebral infraction within 2 weeks, extreme tortuosity of the vessel
* allergic to Calcium channel blockers, angiotensin receptor blockers or hydrochlorothiazide
* pregnancy
* with concomitant medication as following: Azole antifungals, macrolides antibiotics, cardiac calcium channel blockers, Rifampicin, sildenafil, simvastatin, immunosuppressants, antidepressants, valproic acid, cimetidine, aliskiren, NSAIDs, protease inhibitors (ritonavir) and drugs that affect potassium in the blood
* with hepatic insufficiency, renal insufficiency, kidney transplantation, diabetic nephropathy, biliary obstructive disease, or the presence of end-stage disease affecting clinical prognosis assessment (such as end-stage cancer, end-stage heart disease, liver failure, renal failure, pulmonary failure)
* with depression, schizophrenia, bipolar disorder, epilepsy, tuberculosis, AIDS, primary hyperaldosteronism, hyperkalemia, hypercalcemia, hyperuricemia, gout
* participating other trails which would affect the evaluation of outcomes
* with reserpine and clonidine intake within 1 week
Nebivolol ANOCA Treatment Randomized Trial

To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.

Objective To determine the effectiveness of the beta-blocker nebivolol in controlling symptoms and improving the quality of life in patients with angina and coronary microvascular dysfunction.

Hypothesis Treatment with titrated nebivolol will result superior to placebo in symptoms control in patients presenting with coronary microvascular disease (CMD).

Study design Prospective, multicenter, controlled, double-blinded, randomized clinical trial.

Inclusion criteria • Patients over 18 years old with symptoms or evidence of myocardial ischemia and coronary arteries without lesions or with epicardial lesions (\<50% by visual estimation or FFR \>0.80 / RFR \>0.90), and

• CFR ≤ 2.0 and/or IMR≥25 Exclusion criteria Life expectancy \<1 year, inability to provide informed consent, severe valve disease, left ventricular ejection fraction \<30%, clinical contraindication for betablockers treatment.

Treatment arms Randomization will be performed after invasive diagnostic of CMD:

Study group: Nebivolol • Patients will start with a dose of 5 mg every 24 hours. Biweekly dose adjustments will be performed during the first two months, increasing the dose (if tolerated with respect to heart rate, blood pressure, and symptoms) up to a maximum of 20 mg/24 hours.

Control group: Placebo

• Patients will be treated with one tablet every 24 hours. Primary endpoint: The effectiveness of nebivolol treatment in improving angina symptoms was measured using the SAQ questionnaire after 6 months of treatment.

Secondary endpoints • Quality of life at 6 months.

* Functional capacity at 6 months.
* Major cardiac events at 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.

  * Presence of stable angina symptoms, defined as compatible symptoms occurring at least once weekly in the last three months.
  * Absence of functionally significant epicardial coronary artery disease (FFR \> 0.80).
  * Microvascular functional study showing CFR\< 2,0 and/or IMR ≥ 25.

Exclusion Criteria:

* Allergy or contraindication to the use of beta-blockers.
* Indication for beta-blocker treatment due to another pathology.
* Ventricular dysfunction (LVEF \< 45%).
* Percutaneous coronary revascularization in the last 6 months.
* History of surgical revascularization.
* First-degree atrioventricular block or bifascicular block.
* Presence of hemodynamically significant valvulopathy.
* Presence of cardiomyopathy or congenital cardiac anomaly.
* Severe renal insufficiency (eGFR \< 30 ml/min).
* Liver failure (history of cirrhosis or transaminase elevation \> 3 times the upper limit of normal).
* Pregnant or lactating women.
OCD Among Patients With Burns

Estimating the prevalence of OCD symptoms among patients with burns


Eligibility Criteria:
Inclusion Criteria:

* Patients with burns for at least 6 months and are under treatment

Exclusion Criteria:

* Was not defined
Curriculum Evaluation of a Novel Health and Wellness Program Within New York City Schools

The purpose of this study is to compare the academic and psycho-social benefits of a yoga-informed health and wellness program (HWP) to a standard physical education program for middle and high school students within New York City (NYC) schools.

Approximately 100 students at a public New York City High School will be randomized at the level of class into either the experimental (yoga-informed health and wellness program) or control arm (physical education class). Students will receive two classes per week of approximately 45 minutes throughout the academic year. Data will be collected in September 2014 and February and May of 2015.

Eligibility Criteria:
Inclusion Criteria:

* • Male or female students attending NYC schools

Exclusion Criteria:

* Lack of permission to attend physical education class
A Nursing Triage Protocol for Minor Orthopedic Traumata: the Effect on Flow Time, Quality of Care and Patient Satisfaction in an Emergency Department

In 2019, nearly half of all hospital contacts in Belgium took place through the emergency department, and more than a third of patients arrived after an accident or trauma. In instances of overcrowding, patients with minor orthopedic injuries face prolonged waiting times. Previous studies have shown that implementing triage protocols for medical imaging conducted by a triage nurse can reduce the Total Length of Stay (TLOS) for this patient group.

This is a single-center, unblinded, randomized, controlled trial that aims to evaluate the impact of a nurse triage protocol on turnaround time (primary outcome), quality of care, and patient satisfaction. The study population consists of adults who present with minor orthopedic injuries below the elbow or knee and have an Emergency Severity Index (ESI) of 4 or 5. Participants are randomly assigned to either the 'nurse triage protocol' group (n=110) or the 'usual care' group (n=110).


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years old)
* ESI 4 or ESI 5 Recent trauma (\< 10 days after trauma)
* Accidental trauma mechanism
* Trauma below the elbow (forearm, wrist, hand, finger)
* Trauma below the knee (lower leg, ankle, foot, toe)

Exclusion Criteria:

* ESI 1 or ESI 2 or ESI 3
* Return visit after previous emergency department contact for the same injury (e.g. increased pain, tight cast, ...)
* Trauma resulting from underlying somatic pathology (e.g. syncope, epileptic attack, vertigo, vasovagal collapse, ...)
* Atraumatic (pain) complaints (e.g. pain in the calf, toe, foot, wrist, ... without a clear trauma mechanism)
* Additional, non-orthopedic injuries (e.g. laceration, signs of cerebral commotion, ...)
* Pregnancy or a suspicion of pregnancy