cyrilzakka/clinical-trials huggingface dataset:
Clinical Staging Tools for the Impacts of Obesity on Individuals

This study will assess various published staging tools to assess the health impacts of obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity Centres and GPs better assess obese individuals as well as better identify who benefits most from having weight loss treatment.

This study will assess various published staging tools to assess the health impacts of obesity on individuals. The aim is to identify benefits and drawbacks, and thus help Obesity Centres and GPs better assess obese individuals as well as better identify who benefits most from having weight loss treatment

Eligibility Criteria:
Inclusion Criteria:

* Morbid obesity
* At least 1 year follow-up after bariatric surgery

Exclusion Criteria:

* N/A
The Use of FNA and FNB in the Optimization of EUS-assisted Tissue Sampling

Endoscopic ultrasound (EUS) with fine needle aspiration (FNA) for cytology and/or fine needle biopsy (FNB) for histology may be used in the diagnostic work-up of intrathoracic and intrabdominal lesion of unknown origin. Certain lesions (such as pancreatic adenocarcinoma) are often well characterized by cytology assessment of FNA-samples while others are not (such as GIST-tumors).

This study is a part observational (early study phase) and part interventional study (late study phase) on the diagnostic accuracy of EUS-assisted tissue sampling by FNA or FNB during a 10-year period on a tertiary endoscopy centre.

Variables affecting the diagnostic accuracy of EUS-FNA and EUS-FNB in different cases and tumor scenarios will be studied in detail such as the influence of medical equipment used (i.e the different types and sizes of puncture needles), the experience of the endosonographers, cytopathologists and pathologists and the use of rapid on-site evaluation of cytology samples.

Each study case is reviewed post-EUS (according to the schedule precised below) regarding further diagnostic work-up, neoadjuvant treatment, surgery result, clinical follow-up, (neo)adjuvant treatment, and survival. Non-parametrical tests will be applied as the main statistical method.

Eligibility Criteria:
Inclusion Criteria:

* Referral for a diagnostic EUS

Exclusion Criteria:

* Referral for an interventional EUS
Serratus Anterior Plane Block to Prevent Chronic Postoperative Pain in Breast Cancer

Chronic postoperative pain (CPP) remains a disturbing and obscure clinical problem.

The hypothesis of this trial is that a peripheral block of the serratus anterior plane block type preoperatively after a modified radical mastectomy makes it possible to reduce the intensity and incidence of chronic post-surgical pain in breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Having an age greater than or equal to 18 years and less than 70 years
* Having given written consent for participation in the study and the use of personal and medical data
* Having a physical status of class I, II or III of the American Society of Anesthesiologists

Exclusion Criteria:

* Patients who expressed their refusal to participate in the study
* Patients unable to express their non-objection to participation in the study
* American Society of Anesthesiologists class \> III patients
* Known allergy to local anesthetics
* A contraindication to performing a peripheral nerve block (such as an acquired, constitutional or drug clotting disorder or infection at the nerve block injection site)
* Morbid obesity (body mass index greater than 40 kg/m²)
* Chronic use of opioids
* Inability to use the patient controlled analgesia device
* The existence of preoperative pain
* History of neuropathy or neurological pathology
* The existence of catastrophism or anxiety diagnosed preoperatively
Investigates Improvement in Vision Following Switching From Avastin and Macugen Over to Lucentis

The purpose of this study is to determine whether people who have received intermittent anti-VEGF therapy have an improvement in vision after being switched to monthly injections of Lucentis.

To determine mean change in visual acuity at 6 and 12 months

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Age greater then and equal 50 years
* Patients with active neovascular AMD
* Received at least 3 treatments with anti-VEGF therapy (bevacizumab or pegaptanib or ranibizumab) in the last 24 months
* If the patient has bilateral disease and qualifies for the study, both eyes may be included

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from this study:
* Pregnancy or lactation
* Premenopausal women not using adequate contraception.
* Participation in another simultaneous medical investigation
The Effect in Renal Function on Patients With Type 1 Cardiorenal Syndrome Treated With Two Strategies of Furosemide.

In double-blind clinical trial, determine renal recovery with two different furosemide strategies in patients with type 1 cardiorenal syndrome.

In a patient with type 1 cardiorenal syndrome, we tried to compare two Furosemide strategies: both with a morning bolus, and randomized in two groups:

Group A: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:

* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution
* Day 2 Furosemide 200mg / day infused with 100cc of Hartmann solution
* Day 3 Furosemide 300mg / day infused with 100cc of Hartmann solution
* Day 4 Furosemide 400mg / day infused with 100cc of Hartmann solution

Group B: Furosemide 80 mg every 24 hrs (morning) intravenously every 24 hrs for 4 consecutive days, additionally:

* Day 1 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
* Day 2 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
* Day 3 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.
* Day 4 furosemide 100mg / day infused with 100cc of Hartmann solution + Chlortalidone 50mg VO every 24 hours + Spironolactone 50mg VO every 24 hrs.

ution + Chlortalidone 50mg VO every 24 hours + Spironolactone 25mg VO every 24 hrs.

With the primary objective of improving renal function measured by serum creatinine, as secondary objectives the efficacy in vascular decongestion and electrolyte alterations.

Eligibility Criteria:
Inclusion Criteria:

* Comply with both clinical diagnosis of acute kidney injury by serum creatinine according to the Kidney Disease Improving Global Outcomes (KDIGO) 2012 guidelines and acute decompensate heart failure as clinical assessed by the clinical team in charge.
* Have agreed and signed informed consent

Exclusion Criteria:

* Patient in chronic dialysis either peritoneal dialysis or hemodialysis.
* History of being a renal transplant recipient
* History of acute kidney injury according to the KDIGO 2012 guidelines and / or renal replacement therapy in the last 3 months
* Pregnancy
* Impossibility to administer medication by the oral route
A Study Of AG-013736 (Axitinib) Or Bevacizumab (Avastin) In Combination With Paclitaxel And Carboplatin In Patients With Advanced Lung Cancer.

To determine if the addition of AG-013736 to chemotherapy is beneficial in patients with advanced lung cancer who have not been previously treated.


Eligibility Criteria:
Inclusion Criteria:

* Advanced non squamous cell, lung cancer
* No prior treatment for lung cancer except prior adjuvant therapy if last dose was \>12 months prior to enrollment

Exclusion Criteria:

* Prior therapy for advanced lung cancer
* The need for blood-thinners
* Coughing up blood
Correlation of SOZO BIS Measures With CardioMEMS PA Pressure

This study aims to establish the degree to which change in the ratio of ECF to TBW measured using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured using the CardioMEMS HF System (St. Jude Medical).

This is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a CardioMEMS™ device implanted to monitor their diastolic pulmonary artery pressure. The study will recruit and enroll thirty participants. Participants will be monitored daily at home for a period of 30 days. Each day, the patient's diastolic pulmonary artery pressure will be measured by CardioMEMS™ and the ImpediMed's BIS technology. Participant's weight will also be taken each day.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. NYHA Class III HF.
3. Patient has undergone implantation of CardioMEMS HF System (St. Jude Medical).
4. Patient is characterized by at least one of the following:

   * CardioMEMS implanted within the previous 90 days
   * Received treatment with intravenous diuretics within the previous 30 days
   * Received dose escalation of oral diuretics at least twice within the previous 30 days
5. Patient is able to sit upright for BIS measurements.
6. Patient provides written informed consent and authorization to use and disclose health information.

Exclusion Criteria:

1. Patient is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion.
2. Patient has a clinical condition that would not allow them to complete the study.
3. Patient is pregnant or lactating.
4. Patient has nephrotic syndrome or nephrosis.
5. Patient has estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 or end-stage renal disease requiring chronic dialysis.
6. Patient has been diagnosed with lymphedema.
7. Patient has chronic liver failure or cirrhosis.
8. Patient has a moderate or large pleural effusion as seen on chest X-ray.
9. Patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days.
10. Patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator).
11. Patient has an amputation of a limb.
Three Care Models for Elderly Patients With Hip Fracture

Hip fracture in the elderly is associated with excess mortality of 5 to 20%, and mobility problems that usually results in costly hospital stays and lengthy rehabilitation procedures. The purpose of this study is to compare the costs and effectiveness of three care models- acute/sub-acute, comprehensive, and routine care models for hip fractured elders in Taiwan.

Hip fracture in the elderly is associated with excess mortality of 5 to 20%, and mobility problems that usually results in costly hospital stays and lengthy rehabilitation procedures. With this increase in the aging population, hip fracture represents a major and a fast growing health care problem in Taiwan. Currently, the incidence rate of hip fractures is 10 times of the incidence rate for the general population. Despite the use of advanced treatment, the one-year mortality rate (15.4%) remains significant, and many of the patients never recover completely in terms of activities of daily living functions. Many studies in the United States have proved that elderly patients with hip fracture can benefit from post-operative rehabilitation, early discharge planning programs, or transitional care programs. However, little is known about what intervention should be attempted for these patients and their families in Taiwan.

The purpose of this study is to compare the costs and effectiveness of three care models- acute/sub-acute, comprehensive, and routine care models for hip fractured elders in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* Age 60 years or older
* Admitted to hospital for an accidental single-side hip fracture
* Receiving hip arthroplasty or internal fixation
* Able to perform full range of motion against gravity and against some or full resistance, and have a pre-fracture Chinese Barthel Index (CBI) score \>70
* Living in northern Taiwan

Exclusion Criteria:

* Severely cognitively impaired and completely unable to follow orders (determined by a Chinese Mini-Mental State Examination \[MMSE\] score \<10), or
* Terminally ill
Adjunctive Withania Somnifera (Ashwagandha) for Persistent Symptoms in People With Schizophrenia

To determine whether a standardized extract of Withania somnifera will reduce psychopathology scores (PANSS total score) in persons with schizophrenia. A secondary aim is to determine whether WSE reduces measures of positive and negative symptoms (PANSS subscales) and stress scores on the Perceived Stress Scale (PSS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic and Statistical Manual (DSM) 5 diagnosis of schizophrenia or schizoaffective disorder
* Ability to provide informed written consent
* PANSS total score ≥ 70 or a CGI Severity Scored ≥ 4; and at least 2 positive symptom subscale items (i.e., delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility and unusual thought content) scoring ≥ 4, or one of these items scoring ≥ 5, on a scale ranging from 1 = absent to 7 = extreme.
* Evidence of a positive symptom exacerbation during the year prior to study entry.
* For women of child bearing age, a negative serum pregnancy test at screening

Exclusion Criteria:

* Testing positive for illicit substances (positivity to marijuana or opioids will be assessed on a case by case basis due to the long elimination half life in the urine of marijuana and the use of opioids for various pain disorders, caffeine and nicotine are excepted)
* Receiving pharmacological treatment for addictions (naltrexone, suboxone, acamprosate, others) will be reviewed on a case by case basis
* Seriously unstable medical illnesses
* Pregnant or breast feeding women
* Known allergy or history of serious adverse event with WSE
* Subjects who may require imminent hospitalization (examples: suicidal or aggressive behavior)
* Currently receiving antibiotics, anti-viral, or anti-parasitic medications
* Currently receiving immunosuppressive medications (e.g. oral scheduled corticosteroids, chemotherapy or transplantation or HIV/AIDS associated drugs).
Coronary Artery Geometry and the Severity of Coronary Atherosclerosis

The purpose of this study is to investigate the potential association of coronary artery geometry, based on coronary CT angiography (CCTA), with the complexity and the severity of coronary atherosclerosis.

The angulation of the side branch take-off has been reported to influence the severity of atherosclerosis in coronary bifurcations, as larger angles have been associated with increased plaque burden. Data from computational fluid dynamics studies have confirmed this finding by demonstrating that even in the absence of alterations in the amount of branch flow, a wide angle between the side branches intensifies flow perturbations, increases the spatial endothelial shear stress (ESS) variations in the bifurcation region and the low ESS in the lateral walls, thereby augmenting the atherosclerosis-prone environment. The magnitude of reversed flow, the extension of the recirculation zone and the duration of flow separation during the pulse cycle comprise other haemodynamic parameters which are important in atherogenesis and are amplified by an increased bifurcation angle.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for cardiac CT angiography
* Patients without previous history of Coronary Artery Disease (CAD)
* Age ≥ 18 years
* Patients giving voluntary written consent to participate in the study

Exclusion Criteria:

* Pregnancy or breast-feeding
* Patients with serious concurrent disease and life expectancy of \< 1 year
* Patients with a previous history of CAD
* Patients who refuse to give written consent for participation in the study
A Comparison of Insulin Drip Protocols in Labor: A Randomized Trial

To assess which of two commonly utilized insulin drip protocols has better outcomes when used during the labor process.


Eligibility Criteria:
Inclusion Criteria:

* a. Pregnant patients with either pre-existing diabetes or gestational diabetes type A2 who require insulin for euglycemia during labor and delivery

Exclusion Criteria:

* a. Those patients who decline participation
* b. Patients less than age 18 at the time of enrollment will be excluded to protect this vulnerable patient population c. Those patients who cannot be consented d. Patients scheduled for cesarean delivery
Different Doses of Nebulized Magnesium Sulphate in Status Asthmaticus

In this study investigators will use magnesium sulphate in the nebulized form in children between 2 and 12 years of age as an acute reliever for acute severe asthma. Aim of this study is to determine that whether adding low (250mg), intermediate (500mg), and high doses (750mg) of magnesium sulphate in the 1st hour of treatment has any difference in the improvement of clinical condition of the patient and length of hospital stay. There will be total 108 patients having 2 groups. 1st group will receive only Ventolin while 2nd group will be given Ventolin and Magnesium sulphate.

This randomized clinical trial will include 126 patients after taking informed consent who will meet the eligibility criteria. Patients will be randomly distributed in 2 groups on alternate basis as computerized generated number. Improvement will be assessed in terms of clinical condition i.e., Heart Rate, Respiratory Rate, blood pressure, pattern of breathing oxygen saturation and Pediatric Respiratory Assessment Measure (PRAM) score at start of treatment and then afterwards at 20 min interval up to 1 hour and then at 2nd hour and then after every 6 hours for 24 hours.

Eligibility Criteria:
Inclusion Criteria:

1. Children between 2 to 12 years of age.
2. Children with the diagnosis of asthma having a pram score of more than 4.
3. Children with reactive airways

Exclusion Criteria:

1. Critically ill children who require intubation or mechanical ventilation.
2. Having hypersensitivity or allergy to MgSO4.
3. with history of chronic lung impairment.
4. Whose parents are not giving informed consent for participation in research.
A Randomized, Placebo-controlled Trial of Prednisone in Refractory Restless Legs Syndrome: a Pilot Study

Restless legs syndrome is a common sleep-related movement disorder that affects up to 15% of the population in North America, characterized by an uncomfortable urge to move the legs. This has been associated with poor quality of sleep and overall decreased quality of life. Chronic inflammation has been implicated as a key mediator of the low intracranial iron stores that characterize restless legs syndrome (RLS). Current medications for RLS target concomitant low serum iron levels or the dopaminergic pathway, but none target the inflammatory pathway. A novel therapy that focuses on inflammation would allow for additional research into the role of inflammation and cytokines in the development of RLS, and potentially unlock a new class of medications to treat patients with RLS. A small amount of prior evidence suggest that RLS symptoms improve with steroids, with associated improved quality of life, and with decreasing hepcidin levels as a biomarker of symptom severity. This pilot study, using an RCT design, serves to assess the efficacy of glucocorticoids in the alleviation of RLS symptoms, which would further anchor the association between RLS, inflammation, and one of its potential mediators - hepcidin. By giving a prednisone taper versus placebo, this study primarily aims to assess the effect of glucocorticoids on 1) decreasing RLS symptom severity. This study also aims to measure 2) objectively measured improvement in sleep, 3) changes in baseline and post-treatment hepcidin levels, and 4) prevalence of adverse events including psychosis and weight gain. RLS can be a debilitating disease and several non-traditional medications have been tested but with unequivocal results. Glucocorticoids may be an easily accessible and affordable key to better quality of life for RLS patients, especially those with refractory RLS.


Eligibility Criteria:
Inclusion Criteria:

* Outpatient
* Refractory RLS defined as restless legs unresponsive to monotherapy with tolerable doses of first-line agents due to reduction in efficacy, augmentation, or adverse effects
* IRLS score greater than 15

Exclusion Criteria:

* Pregnancy
* Prescence of iron deficiency anemia
* History of Diabetes Mellitus Type 1 and Type 2
* History of uncontrolled hypertension
* Presence of immunosuppression (HIV or currently taking immunosuppressants)
* Any prior adverse reaction to glucocorticoids
* History of dementia or major psychiatric diseases with psychosis
* Lack of ability to understand the experimental protocol and to adequately communicate in English
Testing an Optimal Model of Patient-Centered Cancer Care

The purpose of this proposal is to develop and test the efficacy in a randomized, controlled clinical trial of an Oncology Nurse Care Management (ONCM) program to support cancer patients early in their course. The ONCM program will be compared with an Enhanced Usual Care (EUC) program that will provide education materials and treatment resources for patients. Efficacy will be measured by differences over time in participant-reported Quality of Life, Symptoms and Emotional Distress, and Quality of Care between patients receiving ONCM versus EUC.

Overall Goal:

Our primary goal is to assess the impact on quality of life, quality of care, and other outcomes of two programs designed to support patients newly diagnosed with breast, colorectal, and lung cancer patients. The Oncology Nurse Care Management (ONCM) and Enhanced Usual Care (EUC) interventions will be implemented and evaluated among enrollees of Group Health.

Specific Aims:

A.1. To develop a robust early cancer notification system based on automated data to facilitate intervention shortly after cancer diagnosis.

A.2. To implement an Oncology Nurse Care Management program that addresses patient questions, symptoms, psychosocial needs, and facilitates timely, coordinated care.

A.3. To compare the impact of the Oncology Nurse Care Manager Program with Enhanced Usual Care in Group Health cancer patients using a randomized clinical trial design. Our two primary outcomes are quality of life and patients' perspectives of quality of care. As secondary outcomes, we will evaluate the impact of the intervention on psychosocial distress and depression.

Eligibility Criteria:
Inclusion Criteria:

1. On the panel of an eligible and consenting primary care physician;
2. Diagnosed with a new occurrence of breast (females only) , colorectal, or lung cancer within the past three weeks;
3. Age 18 or older; and
4. Able to complete the baseline questionnaire.

Exclusion Criteria:

1. They plan to disenroll from GH or be out of the area in the coming year; or
2. Primary care physician or specialty physician expects survival to be less than 12 months; or
3. Don't speak English; or
4. Have moderate cognitive impairment (a score of 3 or more on a six-item validated instrument, or psychosis as assessed by ICD-9 codes from GH medical record data.
Quadruple Therapy Versus Dual Therapy as Rescue Regimens for Helicobacter Pylori Infection

The eradication rates of first-line treatment for Helicobacter pylori(Hp) infection are not satisfactory. The study aims to compare the efficacy and safety between quadruple therapy with furazolidone and dual therapy with high doses of amoxicillin as rescue regimens for Hp.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to 80 years, who presented with upper gastrointestinal symptoms and endoscopically proven H. pylori-positive non-ulcer dyspepsia, were recruited into the study.

Exclusion Criteria:

* patients with peptic ulcer,
* previous H. pylori eradication treatment,
* previous gastric surgery,
* pregnancy,
* lactation,
* major systemic diseases,
* receipt of anti-secretory therapy,
* antibiotics or bismuth in the preceding four weeks, or - allergy to any one of the medications in the regimen.