cyrilzakka/clinical-trials huggingface dataset:
Clinical Practice Intensity: Comparing Veterans Affairs (VA) to Private Sector Physicians

This is a national physician mail survey examining primary care practice patterns. The experimental component of the study (the clinical trial) is a randomized trial of different monetary incentive forms and amounts for physicians invited to participate in the study. Only non-VA physicians will be included in this part of the study. (VA physicians are not allowed to receive monetary incentives.) Physicians will be randomized to receive one of four incentives. The main outcome measure is the response rate.

This primary care physician survey is being conducted by Harris Interactive, an international survey research firm working collaboratively under contract to VA investigators heading the study. Surveys will be mailed to a random sample of 1000 non-VA primary care general internists practicing 20 or more clinical hours per week, identified via the Physician Masterfile of the American Medical Association.

The initial survey mailing, delivered via USPS Priority Mail, will include a cover letter inviting the physician to participate, a 12-page survey booklet (including a cover page, a 9-page survey, and 2 blank pages), a monetary incentive, and a prepaid addressed return envelope. The survey is estimated to take 20 minutes to complete. All survey recipients will also have the opportunity, as part of the survey, to request information about practice patterns in their community. Harris Interactive will randomly assign all invited (non-VA) physicians to receive one of four incentives, included in the initial survey mailing.

Non-responders will be contacted two additional times (at approximately 2 and 4 weeks following the initial mailing) by telephone and by mail. Subsequent mailings will include the survey, a cover letter, and a stamped addressed return envelope, but no monetary incentive.

Response rates will be compared between the four arms of the trial; between check v. cash; and between different denominations.

Eligibility Criteria:
Inclusion Criteria:

* Primary care general internists in the United States, identified through the AMA Physician Masterfile, who practice at least 20 hours per week are eligible to participate.
* All physicians included in the sample to whom the survey packets are mailed will be included in the analysis of the incentive experiment, except those for whom a survey packet is returned as undeliverable and those non-respondents identified through follow-up procedures as non-locatable, deceased, or retired.

Exclusion Criteria:

- Physicians self-identified in the AMA Masterfile as medical subspecialists or hospitalists are excluded from the sample.
Study to Compare the Efficacy of Mycophenolate Mofetil in Systemic Sclerosis Related Early Interstitial Lung Disease

Systemic sclerosis is a multisystem disease and can involve the lungs in the form of ILD. Lung involvement is the most common cause of death in these patients. The present study is performed to study the efficacy of oral mycophenolate mofetil in treating early and mild ILD in patients of SSc. The efficacy and side effects of mycophenolate mofetil will be compared with that of oral placebo.

Lung involvement is the leading cause of death among patients with systemic sclerosis (SSc). Treatment with immunosuppression drugs helps in retarding the progression of interstitial lung disease (ILD) and improves the morbidity and mortality among these patients. Presently, cyclophosphamide has been shown to be useful in stabilizing the lung functions among patients of systemic sclerosis with ILD. But use of cyclophosphamide is also associated with many adverse effects including infections, cytopenias, gonadal dysfunction and malignancies. Use of oral mycophenolate mofetil (MMF) in SSc-ILD in recent studies has been shown to be effective in retarding progression of ILD among these patients with a better side effect profile compared to cyclophosphamide. Contemporary expert opinion dictates that the treatment for SSc-ILD needs to be individualized. Generally, intense immunosuppression is required in patients with FVC \<70% of the predicted. In patients with FVC \>70% of the predicted, the need for high dose immunosuppression is not clear and varies from center-to-center. The present study is designed to determine the efficacy of oral MMF in patients with SSc related early ILD. The subjects in this study will be given either oral MMF or placebo and will be monitored for their response and adverse events. Informed consent will be taken from the subjects before including in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of systemic sclerosis with presence of interstitial lung disease on High Resolution Computer Tomography (HRCT) chest
2. FVC ≥ 70% of predicted on pulmonary function tests
3. Age ≥18 years
4. Consenting for participating in study

Exclusion Criteria:

1. Received immunosuppression (except low dose steroids, prednisolone equivalent ≤10 mg/day) for ILD in the last 3 years
2. Persistent leucopenia or thrombocytopenia
3. Pregnant or breastfeeding females
4. Severe pulmonary arterial hypertension (mean pulmonary arterial pressure \>55mmHg) requiring drug therapy
5. Uncontrolled congestive heart failure
6. Any other abnormalities noted on chest X-ray or HRCT other than ILD
7. Active infection
8. Inflammatory myositis
9. Overlap syndrome
10. Mixed connective tissue disease
11. Other serious co-morbidities which could compromise patient's ability to complete the study
Home Vision Monitoring Using the ForeseeHome Device Following Treatment of Neovascular Age Related Macular Degeneration

ForeseeHome, an FDA-approved home device, was specifically designed for unsupervised Preferential-Hyperacuity-Perimeter (PHP) testing of Age Related Macular Degeneration (AMD) patients at home by characterizing central and paracentral metamorphopsia . The purpose of the current study is to evaluate if, in post-treatment patients, PHP parameters as measured with the ForeseeHome are in agreement with clinical decisions and retinal characteristics as measured with optical coherence tomography (OCT).


Eligibility Criteria:
Inclusion Criteria:

1. Received intravitreal antiangiogenic therapy for CNV in the study eye (SE), within 2-12 months prior to the study
2. Last diagnosis was, and current diagnosis is, no CNV activity in SE eye
3. Current plan in SE is clinical examination as standard care but at intervals of not more than 8 weeks.
4. Visual acuity of 20/80 or better in SE
5. Are capable and agree to sign a consent form and participate in the study
6. Age \> 55 year of age
7. Are able to use a standard computer mouse correctly and without assistance
8. Have a working telephone landline at the main residence (cellular communication maybe available for the study, and then eliminate this requirement)
9. Clear view of the macular area on fundus photography
10. Are willing to give their name and contact information to Notal Vision, supplier of the device, so that the company can provide direct services if needed (e.g., assist in using the home device, report the frequency of usage, coordinate replacement of devices in case of a technical problems, etc.)
11. Agree to be examined by an ophthalmologist if SE shows symptoms of changes during the study
12. Have a US address and do not plan on traveling abroad during the study period
13. Fluent in English
14. Perform a reliable ForeseeHome test during the enrollment visit

Exclusion Criteria:

1. Evidence of macular disease other than AMD or glaucoma in SE
2. Presence of any significant media opacity that precludes a clear view of the macular area as identified in SE by biomicroscopy
3. Any non-macular related ocular surgery performed within 3 months prior to study entry in SE
4. Participant are not enrolled in another stuy that could affect the interval between clinical examinations, or the frequency of use of the ForeseeHome device
Chlorhexidine & Pneumonia in Nursing Home Residents

The purpose of this study is determine if topical oral application of a chlorhexidine antimicrobial spray will significantly reduce pneumonia and respiratory infections, and improve oral health compared to a placebo solution in nursing home residents.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be at least 65 years old.
2. Be dependent in 2 or more Activities of Daily Living as noted on the nursing home resident's Minimum Data Set - One must be ADL J- Personal Hygiene.
3. Have natural teeth and/or wear complete or partial dentures.
4. Expected to be a resident in a nursing home for two years.

Exclusion Criteria:

1. Existing pneumonia.
2. History of chlorhexidine reaction or allergy and/or multiple medication or substance allergies.
3. Receiving chlorhexidine oral application at enrollment as prescribed by physician or dentist.
COVID-19 and Sports - an Online Survey on the Impact of the Pandemic and Possible Preventive Measures

Aim of the study was to investigate the effects of the COVID-19 pandemic on individual and general sport activities in an effort to provide information for safe return to community sports.


Eligibility Criteria:
Inclusion Criteria:

-Age over 18 years

Exclusion Criteria:

* age under 18 years
Developing and Validating the Simple Measure of Attitudes and Risk-Taking After ACL Reconstruction (SMART-ACL) Scale

Psychological factors play a critical role in recovery following anterior cruciate ligament (ACL) reconstruction. While tools such as the ACL - Return to Sport after Injury (ACL-RSI) focus on psychological readiness, emphasizing fear, hesitation, and apprehension, the opposite spectrum-overconfidence and risk-taking behaviors-remains underexplored. These behaviors can lead to premature return to high-risk activities and an increased likelihood of re-injury.

To address this gap, we propose the development and validation of the SMART-ACL scale: a Simple Measure of Attitudes and Risk-Taking after ACL Reconstruction. This scale will assess key factors such as patients' willingness to engage in high-impact activities, their adherence to medical guidance, and their perceived readiness to resume sports despite potential physical or psychological limitations.

The SMART-ACL Scale will complement existing tools like the ACL-RSI by focusing on overconfidence and risk-taking, offering clinicians a more balanced perspective on psychological recovery. Validation of the scale will involve testing its validity, reliability and clinical utility to ensure accurate identification of at-risk individuals.

By providing actionable insights, the SMART-ACL Scale will help enhance post-operative care, promote safer return-to-play decisions, and optimize long-term outcomes through a comprehensive assessment of psychological and behavioral factors.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had an ACL reconstruction surgery (isolated or associated with other meniscal or ligamentary surgery)
* Patient included in the sport medicine follow-up protocole
* Patients who have provided informed consent.

Exclusion Criteria:

* Participants who are not included in the Return-to-sport process
P-wave Terminal Force in Patients With Atrial Fibrillation.

It is suggested that P-wave terminal force (Ptf), a product of the amplitude (PAM) and the duration (PT) of the terminal phase of P-wave in lead V1, shows early delay in left atrial conduction, observed earlier that the dilatation of left atrium.

The aim is to follow PT, PAM and Ptf changes during 5-year follow-up (5FU) and examine the relation of these changes to the number of AF episodes requiring hospitalisation (HOSP) for restoration of sinus rhythm (RSR).

Background. It is suggested that P-wave terminal force (Ptf), a product of the amplitude (PAM) and the duration (PT) of the terminal phase of P-wave in lead V1, shows early delay in left atrial conduction, observed earlier that the dilatation of left atrium.

Aim. We aim to follow PT, PAM and Ptf changes during 5-year follow-up (5FU) and examine the relation of these changes to the number of AF episodes requiring hospitalisation (HOSP) for restoration of sinus rhythm (RSR).

We hypothesise that, in patients with atrial fibrillation (AF):

1. the index parameters (PT, PAM, Ptf), characterising left atrial repolarization, correlates the number of future hospitalisations (HOSP) aimed for restoration of sinus rhythm (RSR) in 5-year follow-up (5FU)
2. in 5FU the number of HOSP aimed for RSR correlates with the progression of left atrium electrical remodelling, expressed as PAM5,PT5, Ptf5 at 5FU.

Eligibility Criteria:
Inclusion Criteria:

* documented atrial fibrillation at admission
* successful restoration of sinus rhythms documented in 12-leads ECG,
* follow-up =\> 5 years

Exclusion Criteria:

* arrhythmia other than atrial fibrillation at admission,
* unsuccessful restoration of sinus rhythms,
* successful restoration of sinus rhythms but missing 12-leads ECG recording,
* previous ablation/operation within left atrium,
* follow-up \< 5 years
Genotype Information and Functional Testing Study

This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.

AS DESCRIBED BY THE PI: This study is a sub-study of GRAVITAS (clinicaltrials.gov identifier NCT00645918). The purpose of this study is to assess which genes influence residual platelet reactivity on standard dose clopidogrel therapy, and also to determine whether certain genes influence the incremental change in platelet reactivity with high-dose clopidogrel maintenance dosing in patients who have high residual platelet reactivity on standard dosing.

Eligibility Criteria:
Inclusion Criteria:

* Patients meeting inclusion criteria for GRAVITAS who undergo VerifyNow blood sampling for VerifyNow P2Y12 platelet function testing and IVRS entry for GRAVITAS randomization/selection determination

Exclusion Criteria:

* See GRAVITAS trial (ClinicalTrials.gov identifier: NCT00645918)
The Longterm Risk of Advanced Colorectal Neoplasia After Colonoscopy - A Population-based Cohort Study in Hong Kong

The primary objective of this study is to analyze the 15-year cumulative incidence of advanced colorectal neoplasia and CRC-related mortality after the index colonoscopy.

This is a territory-wide retrospective observational cohort study using the Clinical Data Analysis and Reporting System (CDARS). We will identify patients from CDARS with colonoscopy performed from 1 January 2000 to 31 October 2020. Other relevant diagnoses, procedures, concomitant drugs, laboratory parameters and pathology results will be retrieved and studied.

Eligibility Criteria:
Inclusion Criteria:

1. All patients with colonoscopy performed in HA hospitals during the study period would be eligible for screening.

Exclusion Criteria:

1. Patients with documented personal history of colorectal cancers before the study period would be excluded.
Elocon vs Fluticasone in Localized Psoriasis (P03197)

This is an open-label, randomized, parallel-group clinical study. The primary objective is to assess the difference in response rate between mometasone furoate cream 0.1% (once daily) vs fluticasone propionate cream 0.05% (twice daily) by the end of Day 4 and Day 8 in the management of Indian patients with localized psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* \>=18 years of age
* Written informed consent
* Having localized psoriasis (not more than 5-6 patches)
* Total size of all patches should be below 8" x 8"
* Each patient should exhibit any of the following 4 signs of dermatoses:

  * erythema
  * palpability
  * scaling
  * itching (pruritus)

Each of the above signs would be grades according to the following scale:

0 = none

1. = slight
2. = moderate
3. = severe The total Disease Severity Score (ie, the sum of the scores for each of the signs) should be at least 6 (indicative of a moderate to severe disease status)

Exclusion Criteria:

* Pregnancy or lactation
* Hypersensitivity to any of the components of the test medication
* Signs of atrophy in the target area
* Lesions on palms, soles, and scalp
* Individuals who may require medications that might affect the natural course of the disease
* Not having used systemic corticosteroids or antimetabolites or any other topical corticosteroid within 2 weeks prior to enrollment in the study
* Concomitant tuberculosis/viral infection
Nutritional Supplementation in Head and Neck Cancers

The purpose of this study is to determine whether multimodal nutrition therapy (primary nutrition intervention + adjuvant nutrition therapy) will support patients to optimize their total caloric intake during cancer treatment by measuring the difference in mean cumulative energy intake between the intervention and control group over the duration of cancer treatment.

This will be an randomized, open label, parallel assignment study during cancer treatment (Baseline - Week 7 for Primary endpoint) comparing multimodal oral nutrition therapy versus standard care. Starting at Week 8, all patients receive the intervention arm until study ends at Week 14. Patients in the intervention arm continue the intervention, patients on the standard care arm cross over to the intervention (deferred nutrition intervention).

The primary objective is to assess a multimodal nutrition therapy with two Medical Foods (primary nutrition intervention+ adjuvant nutrition therapy) with features adapted for patients with cancers of the head and neck receiving chemo-radiotherapy treatment, to maintain oral dietary intake during treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must have the ability to read, understand, and sign an informed consent and must be willing to comply with study treatment and follow-up.
2. Male or female
3. ≥18 years of age
4. Histopathologically confirmed primary squamous cell carcinoma of the oral cavity and oropharynx, larynx or hypopharynx, who have agreed to receive radical intent radiotherapy as primary treatment or adjuvant treatment post-surgery, with or without platinum chemotherapy
5. Capable of volitional oral nutritional intake at baseline.
6. A diagnostic CT image taken with a maximum of 30 days before initiation of radical intent radiotherapy. If the CT scan history in the patient's clinical record does not include a study within this window, a baseline non-contrast enhanced CT abdomen will be conducted.
7. An Eastern Cooperative Oncology Group Performance Status of ≤ 2

Exclusion Criteria:

1. Fed by nasogastric tube, gastrostomy or total parenteral nutrition
2. Cancer of the nasopharynx, thyroid or salivary gland
3. Life expectancy \<6 months.
4. A known hypersensitivity / allergy to the investigational product or to any ingredient in their formulations (e.g. Milk/Lactose, Fish).
5. Enrolment in any other clinical protocol or investigational study with an interventional agent or assessments that may interfere with study procedures.
6. Patients with untreated brain metastases (patients with previously resected and/or radiated brain metastases without neurologic symptoms are permitted).
7. Poorly controlled chronic illnesses or other inflammatory diseases (e.g. COPD, uncontrolled non-insulin dependent diabetes, rheumatoid arthritis).
8. In the investigators' opinion, patients who have medical conditions that could interfere with nutrient metabolism or absorption (e.g., short bowel syndrome, Crohn's disease, etc.)
Effect of Acetazolamide on Right Ventricular Function at Rest in Patients With Respiratory Disease at Altitude

This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function at acute altitude exposure in patients with COPD.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function at rest in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

Right ventricular function will be assessed by transthoracic echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, age 18-75 yrs.
* COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.

Exclusion Criteria:

* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC \<0.7, FEV1 \<40% predicted, oxygen saturation on room air \<92% at 750 m).
* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
* Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day)
* Known renal failure or allergy to acetazolamide and other sulfonamides
Safety and Immunogenicity of COVI-VAC as a Booster Dose in Adults Previously Vaccinated Against COVID-19

The purpose of this study is to to evaluate the safety and immune response of COVI-VAC given as a single booster dose in healthy adults previously vaccinated against COVID-19 with an authorised mRNA or adenovirus-vectored vaccine. Approximately 30 participants who have been fully vaccinated ≥ 3 months ago will be enrolled and receive one dose of COVI-VAC. COVI-VAC is administered by drops into each nostril. To assess the safety of the vaccine, each participant will record symptoms and oral temperature in a diary daily for 7 days after receiving COVI-VAC or placebo.

During the full study safety laboratory tests, physical exams, and vital signs (including oxygen saturation) will be conducted periodically for safety. Adverse events and medication use will be recorded.

Blood samples and intranasal samples will be collected periodically to assess the immune response from the vaccine.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women aged 18 to 65 years of age, inclusive, on the day of signing the ICF
2. Body mass index (BMI) ≤ 35 kg/m2
3. In good health with no history, or current evidence, of clinically significant medical conditions with particular reference to, but not restricted to, thromboembolic disorders, coronary heart disease, chronic obstructive lung disease, and no clinically significant test abnormalities that will interfere with participant safety, as defined by medical history, physical examination, vital signs (including oxygen saturation), and safety laboratory tests as determined by the Investigator
4. Previous receipt of an authorised mRNA or adenovirus-vectored COVID-19 vaccine with completion of vaccine regimen ≥ 3 months before Day 1

Exclusion Criteria:

1. Residents of residential care facilities
2. Pregnant or lactating women
3. Inadequate venous access for repeated phlebotomy
4. History of confirmed or suspected SARS-CoV-2 infection