cyrilzakka/clinical-trials huggingface dataset:
The Impact of Cancer on the Physical and Psychosocial Well-being Among Childhood Osteosarcoma Survivors

The aim of the study is to examine the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of childhood osteosarcoma.

Osteosarcoma is the most common primary malignant bone tumor in children and adolescents. The 5-year overall survival rates of childhood osteosarcoma survivors have been increasing substantially with a percentage approaching to 70%. Regrettably, the improved survival rates may lead to long-term sequelae related to disease and treatments that can negatively affect survivors' physical and psychological well-being. Despite numerous studies have examined the impact of cancer and treatment-related late effects on the physical and psychological aspects of osteosarcoma survivors in the foreign countries, it has not been studied specifically in Hong Kong Chinese population. Problems arise when there is a difference in perception and recognition of psychological problems and emotional well-being between Western and Chinese culture. Moreover, the difference in coping strategies between Chinese and Western children also affects how they react and cope with the devastating effect from cancer and its treatments. Due to the cultural and belief differences, the findings from those studies in the foreign counties may not be applicable and transferable in Hong Kong context. There is thus an imperative need to investigate the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among Hong Kong Chinese survivors of childhood osteosarcoma in order to raise awareness of the holistic wellness of osteosarcoma survivors.

Eligibility Criteria:
Inclusion Criteria:

* Hong Kong Chinese under the age of 30 years at the time of study participation;
* Diagnosed with osteosarcoma under the age of 19 years;
* Completed the entire course of treatment at least 5 years;
* Able to speak fluent Cantonese and read Chinese.

Exclusion Criteria:

* Survivors with secondary malignancy, organic cause psychosis, cognitive or learning problems, or under active cancer treatment
Tracer-Guided Surgery for Recurrent Prostate Cancer

ADT with or without robot-assisted PSMA-radioguided surgery for patients with recurrent prostate cancer.

Improving the oncological treatment outcomes in men with a biochemical recurrence after primary prostate cancer (PC) treatment that are diagnosed with a disease recurrence confined to the regional lymph nodes or local residual disease using Prostate Specific Membrane Antigen (PSMA) Positron Emission Tomography and Computed Tomography (PET/CT.)

The proposed trial randomizes patients with recurrent PC following primary PC treatment to either 6 months of ADT or Technetium-PSMA-radioguided salvage surgery plus 6 months of ADT. Although the optimal duration of ADT is unknown, a minimal duration of 6 months of ADT seems advisable in this setting and will be mandatory for both arms.

Eligibility Criteria:
Inclusion Criteria:

* Male, aged ≥ 18 years.
* Hormone-sensitive recurrent prostate cancer after radical prostatectomy, external beam radiotherapy or brachytherapy
* ≤ 2 lymph node metastases or local residual disease within the pelvis with sufficient PSMA expression (≥2 times regional vascular activity level) as determined by PSMA-based PET
* PSA-value \< 4 ng/mL in case of a local recurrence and PSA \< 3 ng/ml in case of (a) nodal recurrence(s)
* Had a PSMA PET/CT within 90 days before surgery
* Suitable for salvage surgery, as per institutional guidelines.
* Charlson Comorbidity Index ≤ 4
* World Health Organisation (WHO) performance status 0, 1, or 2.
* Written and signed informed consent.

Exclusion Criteria:

* Other diagnosis of malignancy or evidence of other malignancy within 5 years before screening for this study (except non-melanoma skin cancer).
* More than 2 lymph node metastases on PSMA PET/CT
* Suspicion of local recurrent prostate cancer within the prostatic fossa not treatable by surgery
* Non-regional lymphadenopathy (cM1a) or distant metastases (cM1b/c) as assessed by preoperative PSMA PET/CT.
* Castration resistance defined by clinical or biochemical progression despite a combined androgen blockade
* Known contraindications to hormone therapy, according to standard recommendations in force
* Patient with a psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule
* Ongoing androgen deprivation therapy (ADT) or within 6 months prior to surgery.
* Severe claustrophobia interfering with PET/CT scanning.
* Absence or withdrawal of an informed consent
New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)

This study will treat pediatric patients who have infections that are due to a specific bacteria (Vancomycin-Resistant Enterococcus)


Eligibility Criteria:
Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary.

Inclusion Criteria:

* Hospitalized/chronic care pediatric patients (birth through 17 years)
* Known infections due to vancomycin-resistant enterococcus species, including diagnosis of hospital-acquired pneumonia, complicated skin and skin structure infections, catheter-related bacteremia, bacteremia of unidentified source, and other infections
* Requires a minimum of 3 days of IV medication
* Patients with mixed infections due to VRE \& gram negative bacteria are allowed to enroll in the study. For most of the infections, 2 or more of additional symptoms are required.

Exclusion Criteria:

* Potentially effective concomitant antibiotic
* A high surgical cure rate
* Medical conditions which would preclude clinical evaluation or require treatment of longer duration than 28 days
* 24 hours of antibiotic treatment within 48 hours of study entry (unless pre-approved)
* Having an infected device that could not be removed
Magnesium Administration After Cardioplegic Arrest With Del Nido Cardioplegia

The cardioplegia solution of choice in many pediatric cardiac congenital programs is the del Nido solution. While many cardioplegia solutions provide diastolic arrest, del Nido provides a longer period of time between doses of cardioplegia. Many of the other cardioplegia solutions do not incorporate magnesium into the constituents, but del Nido does. Routine practice at CCHMC is to dose 25 mg/kg magnesium upon removal of the heart cross-clamp to protect against hypomagnesemia and associated arrhythmias. However, with the incorporation of magnesium in the del Nido solution, it may not be necessary to administer magnesium post cross-clamp and it could in fact be detrimental if the magnesium level is too high. This observational study will examine the magnesium levels prior to and after cross-clamp removal under our current process. The magnesium levels measured after the administration of del Nido cardioplegia and prior to cross-clamp removal will help inform our current practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing cardiac surgery requiring CPB and cardioplegic arrest with del Nido cardioplegia solution.
* Patients planned to receive post cross-clamp dose of 25 mg/kg magnesium sulfate.
Prevelance, Predictors and Outcome of Sepsis Associated Liver Injury (SALI)

prevelance, predictors and outcome of sepsis associated liver injury (SALI)

patient with liver disease and sepsis at the same time

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of SALI
* must take liver support

Exclusion Criteria:

* SALI
* Thyroid disease
Randomized Controlled Trials of the Effects of Decadron on Swallowing, Airway, and Arthrodesis

Anterior cervical discectomy and fusion with or without decompression is a well-established surgical treatment for spine patients with the appropriate indications. Anterior approach involves some retraction that affect the midline structures of the anterior neck. Irritation and swelling may result, leading to postoperative dysphagia and the less common but critically important occurrence of postoperative airway compromise. Steroids given intraoperatively may reduce the incidence of these adverse outcomes by reducing the degree of swelling within the anterior neck subsequent to local surgical tissue trauma.

The investigators hypothesize that the use of steroids intraoperatively provides a significant benefit to the patient, in terms of reduced incidence of dysphagia and airway compromise.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* Cervical spondylosis requiring surgical treatment at 2 or more motion segments
* Ventrally - approachable vertebral levels

Exclusion Criteria:

* Minors (under 18 years old)
* Pregnant women
* Patients currently taking steroids
* Patients requiring surgical treatment at only one segment
* Comatose or incapacitated patients who cannot consent to participate
* Wards of the state
* Persons with an allergy to dexamethasone or related drugs
* Persons employed at Albany Medical Center
Colonoscopy Preparation Optimization for INpatients- COIN Study

Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.


Eligibility Criteria:
Inclusion Criteria:

* Inpatient colonoscopy
* Age greater than 18 years old
* Able to give consent

Exclusion Criteria:

* No consent obtained
* Pregnancy or lactating
* Renal impairment
* Severe CHF (NYHA class 3/4)
* Recent myocardial infarction (preceding 6 months)
* Ileus
* Ascites
* Severe Colitis
* Toxic Megacolon
* Gastrointestinal Obstruction
* PEG tube
* Previous large bowel resection
* Allergy to study drug
Feasibility of Using Contrast Enhanced Voiding Urosonography (CeVUS) During Urodynamic Studies

The investigators will assess the feasibility of replacing fluoroscopy/iodinated contrast with ultrasound/sulfur hexafluoride lipid-type A microspheres during routine urodynamic studies.

Urodynamic studies routinely involve instillation of iohexol (OmnipaqueTM), a low osmolality contrast agent, into the bladder followed by fluoroscopic imaging to assess for reflux or variant anatomy of the genitourinary system. Recently, sulfur hexafluoride lipid-type A microspheres (LumasonTM), an ultrasound contrast agent, has been approved in the United States for intravesicular administration in the pediatric population. Contrast enhanced voiding urosonography (CEvUS) is being increasingly utilized in the place of voiding cystourethrograms, with the major advantages being decreased (zero) radiation for the patient, as well as decreased cost. Given the similarity in procedure between urodynamic studies (UDS) and voiding cystourethrograms, the investigators hypothesize that a urodynamic study may be performed with contrast enhanced ultrasound instead of fluoroscopy. The investigators plan to conduct a small feasibility study by recruiting a group of 30 patients under the age of 18, who are willing to undergo their normally scheduled UDS in addition to CEvUS. The UDS typically consists of two cycles of bladder filling and voiding; the investigators intend to replace the use of fluoroscopy and iohexol with ultrasound and sulfur hexafluoride lipid-type A microspheres. This will decrease the time commitment and eliminate radiation exposure for the patient. There will not be a formal analysis of data as the investigators are planning to test the feasibility of the procedure rather than gather any quantitative data. The goal of the study is to eventually implement CEvUS instead of fluoroscopy in all urodynamic and voiding studies if it is found to be a reasonable alternative. This will decrease pediatric radiation exposure, which will be especially important in the patients undergoing several studies each year.

Eligibility Criteria:
Inclusion Criteria:

* Age 0-18
* Must have had prior urodynamic study at University of Virginia

Exclusion Criteria:

* Pregnant women
* Fetuses
* Neonates
* Prisoners
* Subjects with preexisting cardiac conditions (such as heart failure and ventricular arrhythmias)
* Subjects with a known hypersensitivity to Lumason
Influenza Vaccination and Oral Anticoagulant Therapy

The purpose of this study is to evaluate INR and INR related index and Warfarin weekly dosage variations after Influenza Vaccination

The pharmacokinetic and the pharmacodynamic interactions and the possible clinical events connected with the simultaneous administration of Oral Anticoagulants (OA) and the influenza virus vaccine were evaluated in several small studies which yielded conflicting results, thus encouraging additional investigations with prospective studies in order to obtain a more consistent evidence about the safety and efficacy of vaccination against influenza virus in patients on OA Treatment.

Eligibility Criteria:
Inclusion Criteria:

* OA Treatment
* Stable anticoagulation (previous two controls in range)
* Presence of indication for Influenza Vaccination
* Life expectancy \> 6 months
* Signed Informed consent

Exclusion Criteria:

* Absence of stable anticoagulation
* Absence of indication for Influenza Vaccination
* Life expectancy \< 6 months
* Denied Informed Consent
Effects of Nutritional Supplementation and Dietary Advice in Elderly Patients After Hospital Discharge.

The purpose of this study is to evaluate the effects of nutritional therapy in elderly malnourished patients. The hypothesises are that nutritional supplementation and dietary advice alone or in combination affects mortality, quality of life and health-care consumption after six month of treatment.


Eligibility Criteria:
Inclusion Criteria:

* ≥65 years old
* Admitted to one of the participating wards during the recruitment period

Exclusion Criteria:

* Well-nourished
* No consent to participate
* Not able to communicate
* Not able to understand swedish
* Presumed life-expectancy \<1 year
* Already receiving nutritional therapy including dietary advice, supplements, tube-feeding or parenteral nutrition
* Dietary restrictions due to illness or disease inconsistent with the intervention
* Impaired cognitive function or dementia
* Body mass index ≥35
* Living in old peoples homes, sheltered housing, institution, service flats or nursing homes
* Participant in a study evaluating differences in 3-year mortality between well-nourished patients, patients at risk of malnutrition and malnourished patients
Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)

This study is designed to assess safety and efficacy of intravitreal injection of Conbercept on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .


Eligibility Criteria:
Inclusion Criteria:

1. Patients sign informed consent, and are willing and able to comply with all the follow-ups;
2. Age ≥ 18 years , both genders;
3. Diagnosis of type 1 or type 2 diabetes mellitus;
4. Serum HbA1c ≤ 10%;
5. Study eye must meet the following criteria:

   * Visual acuity impairment caused by DME with involving foveal;
   * BCVA score ≥ 24 and ≤ 73 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 4 meter/1 meter of ETDRS test(Equivalent Snellen chart 20/40 to 20/320);
   * Visual impairment due to Choroidal Neovascularization (CNV) secondary to high myopia.
   * Central retinal thickness (CRT) ≥300μm (spectral domain Optical Coherence Tomography (OCT), the CRT measurements must be confirmed by central reading center);
   * Refractive media opacities and miosis have no effect on the fundus examination.
6. Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320).

Exclusion Criteria:

1. Active infectious ocular inflammation in either eye;
2. Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR;
3. Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy;
4. Iris neovascularization in the study eye;
5. Uncontrolled glaucoma, or history of glaucoma surgery;
6. Aphakia in the study eye;
7. History of vitrectomy in the study eye;
8. History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to the screening, or possibly need panretinal photocoagulation of the study eye during the study;
9. Liver, kidney dysfunction;
10. History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.
Reference Values of Different Functional Tests With or Without Cognitive Dual-task in Young Adults

In this study, reference values for the five basic functional tests that are commonly used, with and without the addition of dual-task activity, will be determined. It will be ensured that healthy normative data that researchers and clinicians can compare in determining the effects in different pathologies by using easy-to-perform evaluations. The aim of this study is to determine the reference values performed with and without dual-task of the five functional tests for young adults according to age and gender by considering the interaction between both mobility and cognitive tasks.


Eligibility Criteria:
Inclusion Criteria:

* 18-35 years
* Individuals who were not diagnosed with musculoskeletal disorder
* Volunteers

Exclusion Criteria:

* Using an assistive device for walking
* Having cognitive problems
* Individuals who had undergone lower extremity surgery due to musculoskeletal problems in the last six months
* Body mass index greater than 30 kg/m2
Real World Evidence of the Effectiveness and Clinical Practice Use of Glecaprevir Plus Pibrentasvir in Patients With Chronic Hepatitis C in the Russian Federation

This study seeks to assess the effectiveness of Glecaprevir plus Pibrentasvir in participants with chronic hepatitis C in a real-life setting across clinical practice populations in the Russian Federation.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve or - pegIFN (or IFN), and/or Ribavirin (RBV) and/or sofosbuvir (PRS) experienced with confirmed CHC, genotypes 1, 2, 3, 4, 5, or 6, with or without compensated cirrhosis, receiving combination therapy with the all oral GLE/PIB regimen according to standard of care, international guidelines and in line with the current local label.
* May be enrolled up to 4 weeks after treatment initiation.
* Patients must voluntarily sign and date Informed Consent Form prior to inclusion into the study,
* Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial.

Exclusion Criteria:

* None.
Prophylaxis Versus Treatment for TURP Syndrome.

This study is designed to investigate the usage \& effects of prophylactic HS preloading, with two different concentrations, to combat the expected dilutional hyponatremia induced by irrigating fluid absorption and to prevent the occurrence of TURP syndrome with its potential complications

The study will be conducted on 60 patients ASA class I - III BPH patients, candidates for TURP surgery using monopolar electronic resectoscope. Eligible patients will be allocated into one of three study groups (n=20 in each). Group A patients will receive NaCl 3% HS at a dose of 4 ml/kg/hr; Group B patients will receive NaCl 3% HS at a dose of 2 ml/kg/hr; while Group C patients will receive NaCl 0.9% Normal Saline(NS) at a dose of 6 ml/kg/hr. All intra-venous infusions will be started 30 minutes before the subarachnoid block, and continued all through the procedure at the same specific rate for each infusion. Vital signs \[mean BP, HR, CVP \& oxygen saturation (spO2)\] will be recorded. Plasma electrolytes (sodium, potassium, chloride)and serum osmolality (mOsm) will be measured. Incidence of TUR syndrome, need for ICU admission, post-operative ventilation and total hospital stay will be noted.

Eligibility Criteria:
Inclusion Criteria:

* ASA class I - III BPH patients

Exclusion Criteria:

* Patients having any condition contra-indicating regional anesthesia e.g impaired coagulation.
* Electrolyte imbalance,
* Uncontrolled hypertension,
* Congestive heart failure or being allergic to local anesthetics.
Interventions for Smoking Among Persons in Recovery

Examine the efficacy of a stepped-care smoking cessation intervention for current and former smokers in chemical dependency treatment programs. We hypothesize that those who received the stepped-care intervention will be more likely to report smoking abstinence and drug or alcohol abstinence at 6 months.

The objective of the study is to document and systematically investigate the use of smoking cessation strategies targeting substance abuse outpatient smokers at various level of readiness to quit smoking. Little is known regarding the best practices in treating tobacco use among clients in drug abuse treatment and very few drug abuse treatment programs currently offer smoking cessation services. The purpose of this developmental study is to develop and pre-test a stepped-care smoking cessation intervention in an outpatient drug abuse treatment program at a managed care setting that targets both current and former smokers. The stepped-care intervention consists of various components that aim at matching the treatment needs of smokers across the whole spectrum of smoking status and readiness to quit smoking. The following specific aims will be pursued:

1. Develop a stepped-care smoking cessation intervention targeting both current and former smokers who are admitted to an outpatient drug abuse treatment program. Special attention will be paid to former smokers, as intervention techniques for them are not well developed. Also, intervention content will be modified from that used in smoking interventions with the general population to content that is targeted at smokers who are in drug abuse treatment
2. Pre-test the efficacy of the stepped-care smoking cessation intervention.
3. Examine the feasibility of implementing the stepped-care smoking cessation intervention.
4. Examine the impact of the smoking intervention on drug and alcohol use outcomes at 6-month post initiation of smoking cessation treatment.

Eligibility Criteria:
Inclusion Criteria:

* men and women
* over the age of 18
* currently enrolled in outpatient treatment program for drug and/or alcohol use and have received minimally 30 days of continuous treatment for drug and/alcohol in any outpatient treatment program(s) for drug and/or alcohol use for at least one month
* have regularly smoked cigarettes for at least one year in their lifetime
* have smoked within the past 5 years

Exclusion Criteria:

* clients with a life-threatening disease
* currently at imminent risk of committing suicide, or currently pregnant
* currently in treatment for nicotine dependence elsewhere
* cannot be reached by telephone (unable to provide a phone number where the participant can be reached directly
* non-English speakers.