cyrilzakka/clinical-trials huggingface dataset:
Patient Registry for Patients With Chronic Subdural Hematoma

All admitted patients diagnosed with unilateral or bilateral chronic subdural hematoma are included into this registry after consent. Clinical condition, radiological details, therapy (intervention/medication treatment/conservative) and outcome are documented. Patient follow-up is documented over at least 24 month with focus on neurological condition (NIHSS), cognitive impairment (MoCA) and quality of life (SF-12 ver. 2).

Chronic subdural hematoma (cSDH) is a frequent disease in- predominantly - elderly patients often caused by minor trauma to the bridging veins eventually leading to a collection of old blood in the subdural space over time. Besides age of the patients a number of further risk factors are assumed to favor pathogenesis. Depending on size and location of blood collections diverse neurological symptoms can be seen. Therapy approaches are heterogeneous ranging from conservative treatment with or without medication to surgical treatment. There also is lacking knowledge regarding neurocognitive impairment and effects on quality of life in patients under different therapy regimes.

The prospective patient registry will enclose all patients admitted to the investigator's department diagnosed with cSDH either by MRI or CT scan after informed consent. Medical history, regular medication, social status, radiological findings and neurological examination using NIHSS will be performed at time of inclusion, discharge and follow-up. Additionally, neurocognitive testing and documentation of Quality of Life using MOCA Test and SF-12 will be conducted at different timepoints. Moreover a detailed documentation of therapy strategies is implemented in the study protocol.

With this registry the study group expects to obtain significant data leading to a more standardized and optimized therapy regime and furthermore widening understanding on so far rarely known impact of cSDH on neurocognition and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* unilateral or bilateral chronic subdural hematoma
* patient consent

Exclusion Criteria:

* acute subdural hematoma
* no patient consent
* subdural hygroma
Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers

The "dry eye syndrome" DES is a highly prevalent ocular disease, in particular in the elderly population. One mainstay of therapy for patients suffering from DES is the use of topically administered lubricants. However, despite many efforts, no "ideal" formulation has yet been found.

Recently, Croma Pharma has introduced chitosan-N-acetylcysteine eye drops, designed for treatment of symptoms related to DES. Chemically, chitosan is a polycationic biopolymer with favourable biological properties such as high biocompatibility and low toxicity. Additionally, the new formulation comprises N-acetylcysteine, which has been used in ophthalmology because of its mucolytic properties for several years. Based on theoretical considerations, one can hypothesize that the new chitosan derivative may show an increased adhesion to mucins of the ocular surface and may therefore be particularly beneficial in reducing the symptoms associated with DES.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 45 years
* Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia \< 6 dpt.

Exclusion Criteria:

* Participation in a clinical trial in the 3 weeks preceding the study
* Abuse of alcoholic beverages
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Ametropia of 6 or more dpt.
* Pregnancy
Study of the Risk of Pharyngocutaneous Fistula in a Population of Patients Undergoing Total Laryngectomy and Creation of a Score for Pre-operative Risk Stratification.

Multicenter retrospective study of a cohort of patients affected by laryngeal carcinoma and subjected to total laryngectomy surgery at the centers participating in the reference period and responding to inclusion criteria.

Evaluate the relative weight of each factor pre-operative risk, in order to build a score (fistula-score) to be able to stratify before surgery surgical total laryngectomy patients in low-risk and high-risk PCF pharyngocutaneous fistula.

Analyze and process data relating to a total of approximately 500 patients underwent, consecutively, total laryngectomy for malignant neoplasm of the larynx

The results obtained from the present study will allow patients to be stratified into low and high risk for PCF to undergo total laryngectomy, so as to reduce this surgical complication

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing LT surgery with direct closure of the pharynx in case of:

* naïve laryngeal neoplasm (cT1-T3 and cT4a without extension to the esophagus or hypopharynx or oropharynx);
* recurrence of laryngeal neoplasm in a patient who has undergone previous surgical treatment (CO2 laser limited within the larynx or OPHL);
* recurrence of laryngeal neoplasm after RT or Ch-RT treatment;
* lack of functionality of the larynx induced by (Ch-)RT treatment;
* Availability of data according to the assessments that will have to be made, including a FU period of 2 months.

Exclusion Criteria:

* Use of flap, pedicled / free, on-lay / in-lay at the same time as LT surgery. Patients previously subjected to trans-oral surgery of the hypopharynx and/or oropharynx.
Role of Embolization of Thyroid Arteries as a Treatment for Different Thyroid Disorders

To investigate the safety and efficacy of selective embolization of thyroid arteries (SETA) as adjunctive or definitive treatment in different thyroid disorders

In graves disease Traditional forms of treatment of the thyroid diseases: pharmacotherapy, radioiodine therapy and surgery can not always be applied. Intolerance, side effects of antithyroid drugs, low iodine uptake, high risk of surgery or disagreement with the proposed treatment was the reason for seeking alternative treatment methods.

Also in cases of large sized thyroid nodule and retrosternal extension, surgery may carries out a lot of comorbidities .

With the development of interventional radiology, and gained experience in the use of arterial embolization, this method has become possible to use in treatment of thyroid diseases. The essence of this treatment is to shut down blood flow in major arteries of the thyroid by direct injection of embolizing materials (PVA) into the vessel's.

. The consequence of acute ischemia is necrosis of the glandular tissue in a field being supplied by this artery. Further repair processes and fibrosis lead to a reduction of active thyroid hormone synthesis and restriction of thyroid gland. Effects of embolization on angiogenesis, apoptosis and autoimmune reactions contribute to compensation thyroid function and significant reduction a goiter volume in course of Graves' disease. Preoperative selective embolization of a huge goiter or thyroid cancer improves surgery outcomes, reduces the risk of hemorrhage and damage to surrounding tissue. Palliative use of embolization in advanced stages of thyroid cancer reduces symptoms and improves quality of life. Little invasive nature of this procedure, the lack of serious undesirable coincidence makes embolization of thyroid arteries an attractive form of a therapy, which may become a therapeutic option in many difficult clinical situations and improve the clinical effectiveness of treatment of thyroid disease

Eligibility Criteria:
Inclusion Criteria:

A- diffuse and Nodular goiter:

B-Toxic goiter:

C-Thyroid cancer:

Exclusion Criteria:

A. Significant bleeding diathesis. B. Contraindication for contrast media (renal impairment or allergy). C. Severe atherosclerotic disease prevent arterial catheterization. D. Refusal of signing a consent
Epidemiology and Prevention of Methicillin Resistant Staphylococcus Aureus (MRSA) Transmission in the Community

The overall goal of this project is to elucidate the epidemiology of MRSA transmission in the community and test an intervention to prevent MRSA transmission in this setting.

The overall goals of this project are to:

1. to investigate the determinants of and evaluate potential interventions to reduce the spread of methicillin resistant Staphylococcus aureus (MRSA) infections in community settings in order to reduce the burden of this illness in the State of Pennsylvania. This objective has the following specific aims:

   * to identify host, microbiological and environmental risk factors for prolonged MRSA colonization, MRSA transmission and clinical MRSA infection among patients with MRSA skin and soft tissue infections (SSTIs) and their household contacts and to use stochastic agent-based modeling methods to quantify secondary spread of CO-MRSA in households.
   * to evaluate the impact of a decolonization intervention on MRSA infections in the household.
   * to identify immunological mechanisms underlying the ability of Streptococcus pneumoniae colonization to inhibit MRSA colonization, transmission and infection in order to identify potential future immunological targets for interventions.
2. to foster multi-disciplinary and cross-institutional collaborations and develop the infrastructure for a Center of Excellence focused on antimicrobial drug resistance research, with the capacity for activities linking basic science, epidemiological and clinical intervention studies
3. to enhance opportunities for basic and clinical research training for undergraduate and graduate students, particularly from underrepresented minorities, in order to increase the pipeline of future biomedical scientists and clinical investigators

Eligibility Criteria:
Inclusion Criteria:

* All members of a household in which the index case is treated for a skin or soft tissue infection due to MRSA. All household members must agree to participate in order for the household to be enrolled

Exclusion Criteria:

* Prior MRSA within past 6 months in the index case; age less than 6 months.
Assessment of vGRF Measurement During Walking With Feetme® Insoles in Healthy Adults

The objective of the present study is to demonstrate the validity and reliability of vGRF and other gait parameters measurement in healthy adults while walking with FeetMe® insoles compared to force plates (AMTI BP400600) and video motion capture system (Vicon NEXUS and MX-T40) .


Eligibility Criteria:
Inclusion Criteria.

Volunteers with following criteria satisfied:

* Between the ages of 18 and 80.
* Shoe size between 35 to 46.
* Body weight from 40kg to 120kg.
* Able to walk for 30 mins without assistance.
* Comfortable with using a smartphone.

Non-inclusion Criteria.

A volunteer will not be included if one of the following conditions is met:

* cognitive or behavioral problems limiting communication or participation in the study
* deprivation of liberty by a legal or administrative decision
* adults subject to a legal protection measure or unable to express their consent
* pregnant, parturient and nursing mothers
* people admitted to a health or social establishment for purposes other than research
* Past or planned surgery with the possibility of impacting walking in the past 3 months or which had an impact on walking: orthopedic surgery, trauma to the lower limbs and spine, urological or gynecological surgery, brain and spinal cord surgery .
* Chronic disease affecting walking: Rheumatological, orthopedic, painful, neurological pathology.
Professionals' Perspectives on Facilitating and Hindering Factors of Implementing Health Promotion Programs in Organizational Settings

Background:

In the field of health promotion, the 'setting approach' has gained increased attention over the last decades. Following this approach, organizations and governments are urged to invest in health and health promotion. However, the dissatisfaction with the broad definition of the term 'setting' has grown. As many health promotion programs are carried out in organizational settings, substantial work has been done on how to acknowledge organizational factors in designing and implementing health promotion programs. Organizational settings differ from others because they can also address their clients as beneficiaries of health promotion programs, also known as 'client-oriented health promotion'. Among the most prominent organizational settings for health promotion are schools and hospitals, and more recently, long-term care (LTC-) facilities. However, dissemination and implementation of client-oriented health promotion in organizational settings seem to be very challenging. Most approaches dealing with barriers to health promotion implementation in schools, hospitals, and LTC-facilities rarely reflect the specific organizational characteristics. This negligence constitutes both, a research gap in the setting approach and in the design of health promotion practice. Hence, the aim of this study is to explore professionals' (teachers', health professionals', care aids') views and attitudes that influence the implementation of client-oriented health promotion programs between schools, hospitals, and LTC-facilities in Austria.

Methods:

With that aim in mind, the investigators chose a comparative qualitative design. Semi-structured interviews will be conducted with 90 professionals (30 in schools, 30 in hospitals, and 30 in LTC-facilities). In addition, non-participant observations as well as an extensive document analysis in each setting will be undertaken. The data will be analyzed by thematic analysis. Comparisons within as well as between the organizational settings will be conducted using selected categories.

Discussion:

To date, this study is the first of its kind that compares results of individual semi-structured interviews between different organizational settings. This study investigates professionals' views and attitudes on facilitating and hindering factors of implementing client-oriented health promotion programs and thus will provide a solid basis for future research activities and evaluation studies in the field of health promotion implementation.


Eligibility Criteria:
Inclusion Criteria:

* Professionals from different levels of the organizational hierarchies
* Professionals from different professional groups
* Professionals with preferably differing views on the usefulness of the health promotion program

Exclusion Criteria:

-
The Effect of Nighttime Dialysis on the Inflammation of Kidney Failure

This study will determine whether a new form of home hemodialysis carried out at night during sleep reduces blood levels of hormone-like substances called cytokines that may cause fatigue and increase blood fats and sugar. Participants will stay twice in the Rockefeller Hospital and receive a standard diet and blood testing. Training for nocturnal hemodialysis will be provided at the nearby Manhattan Dialysis Center of The Rogosin Institute, affiliated with The Rockefeller University.

Patients treated with conventional hemodialysis for at least 3 months and interested in learning home nocturnal hemodialysis will be screened in the Rockefeller Outpatient Research Center. If eligible, during the first 8 day hospital stay, participants will receive a standard diet and dialysis treatment nearby at the Rogosin Institute Dialysis Center. During the last 2 days, their blood will be frequently sampled for cytokines, fats and sugar. Dialysate will also be sampled. They will have the same diet and tests repeated during a second admission after either 4 months of conventional dialysis or 1 month training for nocturnal dialysis followed by 3 months of home nocturnal dialysis (randomized 1:1). After the second admission, patients treated with conventional dialysis will be discharged from the study and trained in nocturnal hemodialysis. Off-site computer monitoring will be utilized when patients dialyze themselves at home or during the admission in The Rockefeller University Hospital.

Eligibility Criteria:
Inclusion Criteria:

Men and women at least age 18 who receive hemodialysis three times a week for at least 3 months and meet the criteria for home instruction in nocturnal dialysis -

Exclusion Criteria:

No diabetes, any unstable clinical condition, chronic infection (including hepatitis, HIV), endocrine disorders or serious digestive problems, lipid-lowering medication , LDL cholesterol \<190 mg/dL and triglycerides less than 600 mg/dL, body mass index \<35, blood pressure \<160/100, hemoglobin \>10.0, no cholesterol-lowering medicine, able to change from Renagel (has lipid effects) to Phoslo for the duration of the study, cigarette smoking no more than half a pack per day
A Study of CSPCHA131 in Patients With Advanced Solid Tumor

The study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CSPCHA131 alone or plus chemotherapy in patients with advanced solid tumors.

This is a dose escalation and expansion study with the aim to evaluate and characterize the tolerability and safety profile of CSPCHA131 alone (Stage I) or plus chemotherapy (Stage II) in patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* 1.18-75 years of age.
* 2. Histologically or cytologically confirmed diagnosis of advanced or metastatic malignant solid tumors, for which standard therapy either does not exist or has been proven ineffective or intolerable for the patient.
* 3. At least one measurable tumor lesion according to RECIST version 1.1.
* 4. ECOG performance status of 0 or 1.
* 5. Life expectancy ≥ 3 months. No cardiac insufficiency or serious abnormalities in the electrocardiogram at baseline.

Exclusion Criteria:

* 1. Administration of chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, other anti-tumor treatments or an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of study treatment.
* 2. Have undergone surgery within 4 weeks prior to the study treatment or have not fully recovered from any previous invasive procedure.
* 3. Adverse reactions to previous anti-tumor treatments that levels have not recovered to grade 1 or less.
* 4. Patients with evidence of uncontrolled nervous system metastasis or meningeal metastases, in the opinion of the investigator, not suitable for enrollment.
* 5. Active infections of grade 2 or above.
* 6. Peripheral neuropathy of grade 2 or above.
CPET Predicts Long-term Survival and Positive Response to CRT

The study tested the usefulness of cardiopulmonary exercise test (CPET) in selection of potential responders to CRT.

Cardiac resynchronization therapy (CRT) is an acknowledged therapy of selected patients with heart failure (HF). One of the unresolved problems is high percentage of non-responders to CRT, reaching 40%. No single parameter, helpful in identifying non-responders prior to CRT implantation, was found.

The study included patients with HF of ischemic or non-ischemic etiology, in NYHA class II-IV, EF≤35% and QRS≥120ms. All the patients had CRT implanted. Clinical evaluation, CPET and NT-proBNP levels measurement were performed before CRT implantation and after 3-6 months. Improvement in HF symptoms of one or more NYHA class correlated with two-years survival. It was used as the criterion of positive response to CRT.

Eligibility Criteria:
Inclusion Criteria:

* HF in class III or IV according to New York Heart Association (NYHA) in the course of ischemic (ICM) or non-ischemic cardiomyopathy (NICM), QRS complex duration ≥ 120ms, EF ≤35% and dilatation of the left ventricle diastolic diameter \>55mm (LVdD), according to the ESC guidelines in 2007
* HF in NYHA class II, LBBB with QRS complex duration ≥ 150 ms according to the guidelines update in 2010
* optimal pharmacotherapy of HF in the period of three months prior to the study entry.
* the expected survival of the patient \> 1 year.

Exclusion Criteria:

* severe chronic obstructive pulmonary disease (FEV1 \<30%)
* inability to perform a stress test on a treadmill
Xylitol BSI Multisite - Reduction of Bloodstream Infections From Oral Organisms in Pediatric Stem Cell Transplant

Bloodstream infections (BSI) caused by bacteria translocating across injured oral mucosa are a significant cause of morbidity and mortality in patients undergoing stem cell transplantation (SCT). Unfortunately, there are currently no known strategies to prevent these BSI in this vulnerable population. The investigators will conduct a randomized, double-blind, placebo-controlled trial at three institutions to evaluate the effectiveness of twice daily intraoral xylitol-wipe application on reducing BSI in pediatric SCT patients.

Patients will be randomized to receive either twice-daily intraoral grape-flavored xylitol-wipe (intervention arm) or grape-flavored saline wipe (control arm) application in addition to the current standard of care (SOC). The purpose of this study is to determine whether xylitol wipes are effective at reducing bloodstream infections (BSIs), dental plaque, mucositis (redness and ulcers in the mouth), or gingivitis in patients who undergo allogeneic stem cell transplant (SCT).

Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated informed consent and assent (when applicable) form
* Willing to comply with all study procedures and be available for the duration of the study
* Admitted and planning to undergo an allogeneic stem cell transplant (SCT) at Cincinnati Children's Hospital Medical Center (CCHMC), Boston Children's Hospital, or Children's Hospital of Colorado (Denver).
* Male or female, 4 months to 25 years of age at the time of SCT (Day 0)
* Have a minimum of one tooth
* Agree to avoid chewing gum and toothpaste that contains xylitol during the intervention period

Exclusion Criteria:

* Prior radiation treatment for cancer of the oral cavity, head, or neck in the past 6 months per the study participant's medical record
* Cranial boost in patients receiving total body irradiation
* Known history of allergy to xylitol
* Known history of allergy to grapes or grape flavoring
* Undergoing a conditioning-free allogeneic stem cell transplant (patient does not receive any chemotherapy or radiation prior to stem cell infusion)
Assessing Balance Changes Following an Exercise Program Among Middle-Aged Adults

This graduate student research study has two purposes; the first purpose is to examine the criterion validity of the Y Balance Test (YBT) with the Limits of Stability Test (LOS) in healthy middle-aged adults. The second purpose is to examine balance changes using the YBT following a home-based exercise program.

4. "Subjects will be healthy female or male middle-aged adults who are able to walk and move independently.

5. "Subjects will be between 45 and 64 years of age." 6. "In total, subject participation will last approximately eight weeks. Visit 1 (baseline): 90 minutes, visit 2 (week 4): 30 minutes, and visit 3 (week 8): 60 minutes.

7. "Subjects will be recruited by distributing flyers in the Loma Linda Community, sending emails to school staff, students, and faculty, and word of mouth.

8. "Consent will take place at Loma Linda University, Nichol Hall rooms A620 -A640 by investigators." 9. If Multi-center: N/A 10. If Single center or investigator-initiated: "70 subjects will participate in the study."

Eligibility Criteria:
Inclusion Criteria:• Healthy adults.

* Age range: 45-64 years.
* Able to walk and move independently

Exclusion Criteria:• Dizziness, visual or neurological disorders that prevent the ability to complete the testing protocol.

* Lower limb injury in the last 3 months.
* Lower limb surgery in the last 6 months.
* Current involvement in a rehabilitation program.