cyrilzakka/clinical-trials huggingface dataset:
Resistance Exercise Training for the Shoulder and Neck Following Surgery for Head and Neck Cancer

The purpose of this study is to investigate the effect of a progressive therapeutic exercise program on specific physical and functional deficits in the neck and shoulder region occurring as a result of head and neck cancer treatment.

We will be conducting a randomized controlled trial to evaluate the effects of progressive resistance exercise training (PRET) on shoulder and neck dysfunction due to spinal accessory neurapraxia/ neurectomy in patients with head and neck cancer. Sixty-four head and neck cancer survivors will be randomly assigned to PRET or standard care. Participants assigned to the PRET group will exercise 3 times per week for 12 weeks. The goal of the exercise program will be to enhance scapular stability, and improve mobility and strength of the upper extremity. The resistance exercise program will be progressive in terms of the number of sets and repetitions performed, as well as amount lifted, depending on baseline strength levels and overall performance status. The primary outcomes for the study include pain and dysfunction, active and passive range of motion measures, strength and endurance testing, and quality of life. Nerve conduction testing and electromyography will be performed to assess/ monitor the status of the spinal accessory nerve and trapezius muscle function respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx OR squamous cell carcinoma metastatic to the neck from unknown primary site; probable occult mucosal origin in the head and neck
2. Surgical treatment includes radical neck dissection, modified radical neck dissection and other variants of functional/selective neck dissection
3. Karnofsky Performance Status greater than or equal to 60%
4. No evidence of residual cancer in the neck and no distant (M0) metastasis
5. Participants must have completed their head and neck cancer treatment

Exclusion Criteria:

1. A history of shoulder or neck pathology unrelated to cancer treatment
2. Serious co-morbid medical illness or psychiatric illness
Web-based Support for People With Type 2 Diabetes

This project will address vital questions regarding how best to design web-based materials for the growing population of patients with basic literacy and computer skills but lower levels of health literacy, building on our previous experience of developing web-based materials for people with lower levels of literacy and health literacy.

This study will be carried out two phases. Phase 1 will use qualitative methods to understand user experiences of the web-based materials through observational 'think-aloud' interviews with users. Phase 2 will test the newly developed web-based materials to a static (non-interactive) version of the materials online.


Eligibility Criteria:
Inclusion Criteria:

* Potential participants are patients with Type 2 diabetes aged 18 years or more, who are able to consent.

Exclusion Criteria:

* Severe mental health problems, palliative care, recent bereavement, known opposition to involvement in research or inability to complete research measures, e.g. learning disability, inability to read / speak English.
Consultation Contents of an Oral and Maxillofacial Surgery Clinic

This study aimed to evaluate conditions and indications in which a training and research hospital directs outpatient and inpatient consultations to an oral and maxillofacial surgery clinic and consider the expectations of physicians in the treatment and management of various conditions.

The patients' consultation forms referred from the clinics and inpatient services of the Faculty of Medicine, Tokat Gaziosmanpasa University, between January 2013 and January 2022 were included in the current study via Enlil-Hospital Information Management System (Eskişehir, Turkey).

The consultation forms which were referred within the same institution or from the external institutions with written consultation notes and the patients with missing demographic data or consultation reports were excluded from the study.

The specific variables such as age, gender, the department in which consultations were requested, and for what purpose the patients were consulted were recorded and classified. During the patient management and treatment process, the responses given to the consultations by the Oral and Maxillofacial Surgery (OMFS) clinic, the physicians' recommendations, the patient management, and the treatments applied were classified and recorded for statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

* The patients' consultation forms were referred from the clinics and inpatient services of the Faculty of Medicine, Tokat Gaziosmanpasa University, to the Department of Oral and Maxillofacial Surgery of the same affiliation.

Exclusion Criteria:

* The consultation forms which were referred within the same institution or from the external institutions with written consultation notes and the patients with missing demographic data or consultation reports
Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer

To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative colorectal cancer.

A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Eligibility Criteria:
Inclusion Criteria:

1. Histological diagnosis of colorectal adenocarcinoma.
2. Measurable or assessable lesions.
3. Age: 18 \~ 75 years.
4. Performance Status (ECOG): 0 \~ 2.
5. No prior chemotherapy or only one regimen of previous chemotherapy (with a washout period \>4 weeks after the final day of the previous therapy). Adjuvant chemotherapy is not defined as previous therapy.
6. No history of treatment with CPT-11 or S-1.
7. No history of radiotherapy to the abdomen.
8. Oral intake of S-1 is possible.
9. Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC 3,500/mm3 and 12,000/mm3. Hb 10.0 g/dl. Platelet count 100,000/mm3. GOT and GPT 2.5times the upper limit of normal (excluding liver metastasis). T-Bil 2.0mg/dl. Creatinine \<1.5 mg/dl (but if it is 1.0 \~ 1.5 mg/dl, the dose of S-1 can be decreased according to the dose reduction criteria to allow registration in the trial). Normal ECG (not considering clinically unimportant arrhythmias and ischemic changes).
10. Predicted survival for \>3 months.
11. Able to give written informed consent

Exclusion Criteria:

1. Severe pleural effusion or ascites.
2. Metastasis to the central nervous system (CNS).
3. Active gastrointestinal bleeding.
4. Active infection.
5. Diarrhea (watery stools).
6. Uncontrolled ischemic heart disease.
7. Serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
8. Active multiple cancer.
9. Severe mental disorder.
10. Pregnancy, possible pregnancy, or breast-feeding.
11. Flucytosine treatment
12. Gilbert's syndrome (4).
13. Judged to be ineligible for this protocol by the attending physician.
Compression And Functional Ability After Endovenous Varicose Vein Treatment

Study's aim is to study possible differences in post-operative rehabilitation, functional ability and visual disturbances after endovascular varicose intervention (RF-catheter and foam sclerotherapy) in two study groups, where patients will be randomised to either no compression group (Group I) or compression group (Group II)


Eligibility Criteria:
Inclusion Criteria:

* Duplex ultrasound verified GSV, AASV and/or SSV incompetence suitable for radiofrequency ablation
* Comprehensive Classification System for Chronic Venous Disorders (CEAP) rated from C2 to C4
* Distal varicose vein insufficiency suitable for sclerotherapy
* Patient willingness to participate

Exclusion Criteria:

* History of pulmonary embolism or deep venous thrombosis
* Large (\>12mm) truncal vein diameter
* CEAP C5-C6
* Antithrombotic medication (ASA accepted)
Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy

Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.

Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.

Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.

Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.

Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).

Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A or B.
* Persons over 18 years of age.
* Patients with a medical diagnosis of ankle arthropathy (with clinical assessment of more than 4 points on the Hemophilia Joint Health Score.
* Patients on prophylactic or on-demand treatment with FVIII / FIX concentrates.
* Sign the informed consent document.

Exclusion Criteria:

* Patients with inhibitors (antibodies against FVIII or FIX) without treatment with monoclonal antibodies.
* Patients with neurological or cognitive alterations that impede the comprehension of questionnaires and physical tests.
* Patients who have developed an ankle hemarthrosis in the 3 months prior to the study.
* Patients who at the time of the study are receiving ankle physiotherapy treatment.
Project Looking-Glass Evaluation

Pilot study to validate the new design and workflow of Cone-Beam CT imaging for radiation therapy treatment simulation.

This study is a prospective, non-randomized imaging evaluation study. A cohort of subjects undergoing standard of care radiation therapy will be selected based on malignancies from six disease sites. The Halcyon 4.0 images acquired in place of standard evaluation CT scans during the course of treatment will be used for target volume delineation and normal structures segmentation. Treatment plans will be recalculated based on the Halcyon 4.0 images from this system and compared to the original treatment plan. Dose differences will be evaluated. Two-tailed t-test will be used to compare the statistical significance of the dosimetric results as well as the volumetric differences among target volume and the volumes of organs at risk.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be treated with external beam radiotherapy at the Perelman Center for Advanced Medicine for any of the following malignancies: head-and-neck, thoracic, breast, gastrointestinal, gynecologic, or genitourinary.
* Age ≥ 18 years
* Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician
* Availability of a complete set of treatment plans, including CT simulation images, target and normal structure contours, and radiation treatment prescriptions

Exclusion Criteria:

* Subjects who are pregnant or have plans for pregnancy during the period of treatment.
* Any malignancy not stated above.
* Those unable to be treated on any linear accelerator (whether Truebeam™ or Halcyon™) unit either due to subject anatomy or treatment plan.
* Those undergoing proton therapy.
An Observational, Prospective Evaluation of the Trifecta™ Valve

This trial is designed to confirm the clinical safety and effectiveness of the Trifecta valve by establishing associated adverse event rates, clinical status as indicated by New York Heart Association (NYHA) functional classification, hemodynamic performance, and hematology analysis.

The clinical investigation is a multi-center, multi-country, prospective, non-randomized, observational study without concurrent or matched controls, designed to evaluate the safety and effectiveness of the Trifecta valve. A maximum of 120 subjects requiring aortic valve replacement will be implanted at a maximum of 6 investigational sites in Europe. The sample size is based on late patient-years of follow-up with a minimum of 400 late patient-years experience required.

Eligibility Criteria:
Inclusion Criteria:

1. Patient requires aortic valve replacement. (Note: patients undergoing concomitant procedures, e.g. coronary artery bypass grafting, or valve repair, are eligible for this study).
2. Patient is legal age in host country.
3. Patient (or legal guardian) has given written informed consent for participation prior to surgery.
4. Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.

Exclusion Criteria:

1. Patient is pregnant or nursing (women of child bearing potential must have a documented negative pregnancy test within one week prior to surgery).
2. Patient already has a prosthetic valve(s) at a site other than the aortic valve.
3. Patient requires concomitant replacement of the tricuspid, pulmonary, or mitral valve.
4. Patient has an inability or is unwilling to return for the required follow-up visits.
5. Patient has active endocarditis (patients with previous endocarditis must have two documented negative blood culture results prior to enrollment).
6. Patient has had an acute preoperative neurological event defined as patient has not returned to baseline or has not stabilized 30 days prior to the planned valve implantation surgery.
7. Patient is undergoing renal dialysis.
8. Patient has a documented history of substance abuse within one year of enrollment or is currently a prison inmate.
9. Patient is currently participating in the study of an investigational drug or device, or the patient was previously participating in an investigational drug study and has not completed a 30-day wash out period.
10. Patient had the Trifecta valve implanted as part of this study, but then had the device explanted.
11. Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
12. Patient has a life expectancy less than two years.
The Effects of Mindfulness Training on School Staff

The primary research objective is to investigate psychological, behavioral, and physiological changes in school staff as a result of undergoing meditation and stress reduction training. Specifically, we hypothesize that school staff undergoing meditation and stress reduction training will show decreased emotional distress on self-report measures, increased sustained attention on a behavioral task, and decreased stress levels as indexed by salivary cortisol.


Eligibility Criteria:
Inclusion Criteria:

* Staff from Madison, WI area elementary school

Exclusion Criteria:

* N/A
Community Care for Croup (RCT)

This randomized clinical trial was to compare the effectiveness of prednisone 2mg/kg/day for 3 days vs. dexamethasone 0.6mg/kg for 1 day for treatment of children with mild or moderate croup. It was conducted in a practice-based research network of community pediatricians in the St. Louis area. Outcomes included additional health care for croup, duration of symptoms, nights of disturbed sleep, parental stress, missed work days, and adverse events. Our hypothesis was that community-based treatment of children with mild or moderate croup with multiple doses of prednisone is superior to a single dose of dexamethasone.


Eligibility Criteria:
Inclusion Criteria:

* children aged 1 to 8 years old (not yet reached their 9th birthday), who have croup symptoms for less than or equal to 48 hours and have a physician diagnosis of mild or moderate croup.

Exclusion Criteria:

* Severe croup or impending respiratory failure;
* another reason to indicate the need for hospitalization;
* symptoms or signs to suggest another cause of stridor;
* active varicella infection;
* diabetes;
* known immunodeficiency disease;
* chronic respiratory disease such as CF (Cystic Fibrosis);
* prescribed a controller medication or oral steroids for asthma in the past 12 months;
* a history of TB(tuberculosis) in a household member;
* treatment for seizures;
* treatment with epinephrine or oral corticosteroids for this croup episode before enrollment;
* not accompanied by their legal guardian;
* the accompanying adult will not be in the same household as the child for the next four days;
* parent/legal guardian is unavailable for telephone follow-up or does not speak English.
Brain Imaging Study of F17464

Assess the binding rate of F17464 to cerebral receptors in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Male healthy volunteers

Exclusion Criteria:

* Presence or positive history of severe medical illness or psychiatric conditions
Reconstruction of Localized Alveolar Ridge Defects

The aim of the present prospective randomized controlled study is to compare the clinical, radiological, micro-circulation, and histology of a novel, semi-thick, and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation.

The aim of our study was to compare the clinical, radiological, circulatory, and histological studies of a novel, split-thickness and conventional full-thickness mucoperiosteal flap technique during horizontal alveolar ridge augmentation surgeries. Flap formation was performed in the test group using the novel split-thickness surgical technique, and in the control group using the full-thickness mucoperostatial surgical technique. The novel split-thickness flap technique to be studied results in a predictable, closed healing based on our preliminary results, thus ensuring the conditions for successful augmentation. We primarily want to investigate what hard and soft tissue changes result from ridge augmentation with a novel split-thickness flap technique after 6 months, compared to a surgical technique based on full thick flap formation accepted as a standard procedure in the literature. Our secondary examination methods: examination of early wound healing and micro-circulation after augmentation interventions by LSCI method; histological evaluation at prosthetically designed implant positions.

Eligibility Criteria:
Inclusion Criteria:

* at least one edentulous maxillary/mandibulary premolar or molar site with horizontal bone loss
* full- mouth plaque and bleeding scores (FMPS and FMBS) \<20%
* good patient compliance (including willingness to participate in the follow-up procedures) signed informed consent-

Exclusion Criteria:

* Active infectious diseases (HBV, HCV, HIV, TB, SARS CoV-2, etc.)
* Current chemotherapy or radiotherapy
* Radiation treatment of the former head and neck region (not older than 2 years)
* Untreated insulin-dependent diabetes mellitus
* Clinically significant osteoporosis or other systemic disease affecting bone metabolism
* Clinically significant circulatory disorders such as decompensated cardiac failure
* Haemodynamically significant heart failure or myocardial infarction within the last 3 months
* Clinically significant coagulation disorder
* Current or previous systemic corticosteroid therapy (not older than 2 months)
* Current or previous systemic bisphosphonate therapy
* Pregnant or breastfeeding mothers
* Smoking
* Drug addiction, alcoholism
Heart Lung Machine Registry

The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing cardiac / thoracic / vascular surgery.

In this study, patients who are connected to the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric and undergo a cardiac / thoracic / vascular surgery will be observed. This includes neonates, infants, adolescents and adults regardless of age and underlying health condition. It also includes elective, urgent and emergent surgeries.

Data will be collected for each participant according to the study schedule and standard routine clinical practice at the enrolling centers. There will be no additional visits, nor procedures pertaining to the study itself for subjects who participate in the study.

Informed consent of the patients will be obtained to allow the use of their clinical records for the purpose of this observational study before data are being collected.

The period of data collection for each patient will be only the index procedure. The index procedure is defined as the investigator's planned initial procedure in which the patient is connected to the HL 40 and the Temperature Probes. The index procedure starts with the cannulation of the patient for the index procedure and ends with the de-cannulation of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Signed Patient Informed Consent (including emergency approach)
* All patients who are connected to extracorporeal circulation using the index devices.

Exclusion Criteria:

* Pregnancy
* Current participation or planned participation in a concurrent drug or interventional medical device study
Benefits of a Higher Protein, 'Egg-cellent' Breakfast in the Classroom

This study will test whether whether the implementation of and Egg-cellent 'Breakfast in the Classroom' improves school breakfast participation and breakfast consumption in middle school adolescents; whether the implementation of 'Breakfast in the Classroom' improves appetite control, mood, cognitive performance, and unhealthy snacking behavior in middle school adolescents when compared to a traditional school breakfast program.

The investigators propose an 4-week cross-over design breakfast study in children enrolled in 6-8th grade within the Center School District in the Kansas City, Missouri. This school will begin their 'Breakfast in the Classroom' program on March 26, 2018. Prior to the start of 'Breakfast in the Classroom', baseline data will be collected on the students who wish to participate in the study. Baseline data includes anthropometric assessments; demographics; current eating habits; cognitive performance; appetite; and mood. Following baseline, the students will be provided a breakfast that meets all the requirements for a reimbursable school breakfast with the addition of two eggs for 3-weeks: At 4 weeks (3 weeks after initiation of the program), the study participants will complete a similar outcomes to those completed at baseline.

Eligibility Criteria:
Inclusion Criteria:

* All students from the Center Middle School in Kansas City, MO who choose to participate and whose parent/legal guardian (excluding Wards of the State) signs the consent will be included.

Exclusion Criteria:

* Wards of the State will be excluded from this study.