cyrilzakka/clinical-trials huggingface dataset:
Questionnaire Pre-Test Study

Background:

The Division of Cancer Epidemiology and Genetics does research into the causes of cancer and ways to prevent it. It uses data from questionnaires. Sometimes, pre-testing a questionnaire with a group of volunteers can help researchers find errors in it and learn ways to improve it.

Objectives:

To test a questionnaire for problems that might cause response errors and to develop ideas for improving it. To test how long it takes people to complete it.

Eligibility:

Adults ages 35-75. Volunteers both with and without a history of tobacco use and with or without a family history of cancer are needed.

Design:

Participants will be screened with a phone call.

Participants will be told what background data to bring to the 1 study visit.

An interviewer will give the participants the questionnaire. It will be done with pen and paper. It will take about 1 hour.

There will be multiple-choice and open-ended questions. They will be about lifestyle, medical, and environmental factors. Some of the questions will be about possibly illegal or highly sensitive behaviors.

Participants will note any questions that they find hard to answer for any reason. They will be asked to answer the best they can, but they can skip any question that they prefer not to answer.

The personal data of participants will be deleted when the study is done.

The interviewer will observe participants while they do the questionnaire. He or she will look for things like long pauses and confusion.

Participants will discuss the exam with the interviewer after they finish. This will take about 1 hour.

The mission of the Division of Cancer Epidemiology and Genetics (DCEG) is to conduct broadbased, high quality, high impact research to uncover the causes of cancer and the means of its prevention. To this end, DCEG relies on epidemiologic data captured on self-reported questionnaires. The purpose of this pre-test study is to pilot a questionnaire to: (1) detect problems that might contribute to response errors; (2) develop ideas for improving the questionnaire in order to minimize such errors; and (3) assess the length of time to complete the questionnaire. If there are specific sections of the questionnaire that are skipped by all 30 initial participants, then six (6) additional, separate individuals may be invited to pre-test the questionnaire for sections that were missed by the initial set of participants. After a post-revision of the questionnaire based on the pre-test results, up to 10 additional, separate individuals will be invited to test the revised questionnaire for duration and comprehensibility.

Eligibility Criteria:
* ELIGIBILITY CRITERIA:
* Age 35 to 75
* Men or women
* Fluent in English
* Able to come to the SSS Durham, NC offices for the in-person interview
* Able to provide informed consent
BEAT-IT: Behavioural Activation and Severe Learning Disabilities

Depression is common, but no psychological interventions have been tested to see if they work for adults with severe intellectual disabilities. The research team recently successfully completed a full-scale trial of a psychological intervention, BeatIt, for depressed adults with mild/moderate intellectual disabilities. The aim of this study is to comprehensively evaluate the feasibility of modifying BeatIt for depressed adults with severe intellectual disabilities, collecting the information needed on likely recruitment, measures, and waiting list control arm options, to design a full-scale study.


Eligibility Criteria:
Inclusion Criteria:

* Severe/profound intellectual disabilities
* 18 years old and over
* Clinically significant unipolar depression
* Has a family member or paid carer who has supported them for a minimum of 6 months to complete the screening and baseline visits OR is able to obtain information for the previous 4 months prior to randomisation. The carer, or another named individual, should be available for weekly-fortnightly treatment sessions with the practitioner, and should currently provide a minimum of 10 hours support per week to the participant.

Exclusion Criteria:

* Suicidal
* Mild/moderate intellectual disabilities
* Factors that prevent the person from interacting with the carer and therapist or retaining information from the therapy (e.g. late stage dementia, significant agitation, withdrawal arising from psychosis)
* Does not consent to her/his GP being contacted about their participation in the study.
Study of the Incidence and Prognosis of Intrahospital Acute Kidney Injury

The goal of this observational study is to investigate the epidemiology of acute kidney injury in hospitalized patients. The main question it aims to answer is: how frequent is the development of acute kidney injury in patients who are hospitalized? Data from participants will be retrospectively collected from medical charts.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalised from 01/01/2019 to 31/12/2023
* Availability of a Hospital Discharge Form
* At least one serum creatinine (sCr) determination available

Exclusion Criteria:

* Day-hospital admission
* Discharge after an emergency room admission without hospital admission
* Stage IV and V CKD
SWOG-9430: Surgery in Treating Patients With Metastatic Melanoma

RATIONALE: Surgery may be effective therapy in treating patients with metastatic melanoma.

PURPOSE: This phase II trial is studying how well surgery works in treating patients with metastatic melanoma.

OBJECTIVES:

* Assess overall and progression-free survival in patients with metastatic melanoma (beyond the draining lymph nodes) after complete surgical resection of all known disease.
* Determine the ability of the Southwest Oncology Group Melanoma Committee to enroll patients with metastatic melanoma who can be resected to a disease-free state.

OUTLINE: This is a multicenter study.

All patients undergo gross total resection of all known disease. Patients whose disease cannot be completely resected or who have disease recurrence after surgery are removed from study. Patients found to have microscopic residual disease after surgery are considered completely resected. Resected tissue is submitted for analysis on protocol SWOG-9431.

Patients may receive any adjuvant therapy (e.g., radiotherapy, interferon, and/or vaccines) deemed clinically appropriate by the treating physician.

Patients are followed periodically for 5 years after study entry.

PROJECTED ACCRUAL: A total of 100 eligible patients with completely surgically resected disease will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic melanoma that is deemed grossly surgically resectable

  * Multiple resected sites or metastatic melanoma of unknown primary allowed provided all known disease can be grossly resected
  * Recurrence in iliac lymph nodes after inguinal lymph dissection allowed
* No metastatic disease beyond the lesions planned for resection

  * Confirmed by CT scan of chest, abdomen, pelvis, and CT or MRI of brain within 42 days of study
* Concurrent registration on protocol SWOG-9431 required

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* SWOG 0-2

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which patient is currently disease free
* Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior immunotherapy in the adjuvant or metastatic setting allowed

Chemotherapy:

* Prior chemotherapy in the adjuvant or metastatic setting allowed

Endocrine therapy:

* Prior hormonal therapy in the adjuvant or metastatic setting allowed

Radiotherapy:

* Prior radiotherapy in the adjuvant or metastatic setting allowed

Surgery:

* See Disease Characteristics
* At least 14 days since prior surgery in the adjuvant or metastatic setting

Other:

* Recovered from prior therapy
Efficacy and Safety Study of Nasacort in Chronic Non Allergic and Non Infectious Rhinitis in Adults

To demonstrate the superiority of the clinical efficacy of 12 weeks' treatment with Nasacort versus placebo in adult patients presenting with Chronic Non Allergic and Non Infectious Rhinitis


Eligibility Criteria:
Inclusion Criteria:

* patient presenting with Chronic Non Allergic and Non Infectious Rhinitis capable of benefiting from corticosteroid therapy administered via the nasal route.
* patient with chronic rhinitis of minimum duration 12 weeks, whether or not consecutive, per year.
* patient with Non Allergic Rhinitis confirmed by negative phadiatop test.
* patient presenting a mean global score for the 5 symptoms \>= 5 (nasal obstruction, rhinorrhea, disturbance of sense of smell, sneezing, facial heaviness), or mean score for the 3 main symptoms (nasal obstruction, rhinorrhea, disturbance of sense of smell) \>= 5 (mean for 7 days prior to visit V0).
* patient presenting an inflammation score at anterior rhinoscopy or nasal endoscopy \>= 4.

Exclusion Criteria:

* patient presenting a nasal polyp
* patient presenting a severe septal deviation which would interfere with insertion of the nasal spray
* patient presenting a nasal cavity tumor
* patient presenting a sinus infection
* patient presenting a history of endonasal surgery
* patient presenting a chronic rhinitis of extrinsic origin (drug-related or food-related rhinitis) or intrinsic origin (hormonal rhinitis, positional rhinitis,atrophic rhinitis, ...)
* patient on a program of intensive sports training
* patient presenting with : cystic fibrosis, pulmonary mycosis, necrotising vascularitis, immotile cilia syndrome, ....
* patient presenting with known immunosuppression, lymphoma
* patient presenting with a known cardiovascular, neurological or other medically significant illness
* patient presenting with known renal failure, with known glaucoma, with known drug addiction
* current antibiotic therapy
* corticosteroids administered in the two months prior to admission
* patient presenting problems of haemostasis (epistaxis), ophthalmic and/or oro-bucco-nasal herpetic infection.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Preoperative Cataract Pupillary Dilation: Inpatient At The Ambulatory Surgery Center vs Outpatient Dilation Prior To Arrival At The Ambulatory Surgery Center

This study was done to compare efficacy, safety and efficiencies of various methods of pupil dilation prior to cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Ability to self administer eye or have a helper for the task of administering eye drops.
* Ability to follow and eye drop administration schedule.
* No noted ocular abnormalities.
* Bilateral cataract surgery anticipated.

Exclusion Criteria:

* Inability to self administer eye drops or have assistance with eye drop administration.
* Health problems that would contraindicate self administration of dilating eye drops such as poor cardiovascular or respiratory status.
Screening Algorithm for Early Detection of Occult Cardiac Amyloidosis

Early diagnosis of cardiac amyloidosis (CA) is crucial because of the poor overall survival, high mortality and the need for early therapy including new treatment possibilities for transthyretin amyloidosis. Previously considered a rare condition, CA is being demonstrated to account for up to 17 % of heart failure with preserved ejection fraction cases as well as up to 16 % of Patients with severe aortic stenosis, undergoing surgical of transcatheter aortic valve replacement. It seems that CA is being underdiagnosed as the data of post-mortem studies demonstrate that at least 25% of elderly individuals have histologic evidence of amyloid deposits. Other common conditions with increased afterload such as hypertensive or hypertrophic heart disease that mimic echocardiographic features or clinical symptoms may be the reason of postponed recognition of CA. Furthermore, the lack of definitive biomarkers makes the diagnosis even more challenging. However, it has been shown that some clinical, laboratory and echocardiographic findings, so called "red flags", may indicate occult CA. A deeper and constructive analysis of the findings and establishment of prediction criteria could possibly lead to improvement of early CA recognition and survival in subjects at risk. We aim to prospectively perform a systematic screening for CA in individuals at risk based on predefined selection criteria. Our aim is to evaluate if specific criteria would lead to increased detection of CA and in this case, to define major and minor diagnostic criteria.

The study aims to perform a prospective screening and detect occult CA in subjects at risk with aortic valve stenosis, undergoing either transcatheter or surgical aortic valve replacement. The study has two main objectives. Firstly, we aim to determine the real prevalence of CA according to the targeted "red flags" analysis and secondly, we aim to establish an algorithm for early detection of CA.

Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of following four criteria: 1) Severe aortic stenosis. 2) Age \> 65 years for male and \>70 years for female. 3) Increased left ventricular wall thickness ≥14 mm. 4) Blood pressure ≤ 140/90 mmHg and at least 1 major or ≥ 2 minor criteria.

Major criteria:

1. Carpal tunnel syndrom
2. Non-traumatic rupture of the biceps tendon
3. NT-proBNP \> 1000 pg/ml
4. hs Troponin value above the 99th percentile without dynamic changes (≤ 20%)

Minor criteria:

1. Diastolic dysfunction (at least grade 2, E' \< 10 cm/s)
2. Sinus bradycardia/AV block/pacemaker
3. Atrial fibrillation

Exclusion Criteria:

* Known cardiac amyloidosis (ATTR or AL)
* Unable to provide written informed consent
* Refusal to provide written informed consent
* Contraindications for study investigations
Change of Gut Microbiome and Symptom After H.Pylori Eradication Therapy in Patients With Functional Dyspepsia

The aims of the investigators' study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

Accumulating evidence shows that Helicobacter pylori protects against some metabolic and immunological diseases in which the development of these diseases coincide with temporal or permanent dysbiosis. Helicobacter pylori eradication therapy has the potential to improve symptoms of functional dyspepsia. The aims of our study are to investigate the effect of H.pylori eradication on the human gut microbiome and symptoms of functional dyspepsia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who has diagnosed with functional dyspesia by Rome IV criteria

Exclusion Criteria:

* Known GI malignancy
* Previous Helicobater pylori eradication history
* Severe systemic disease
* Previous GI surgery
* Uncorrectable coagulopathy: INR \> 1.5 or platelet \< 50,000/ml
* Pregnant or breastfeeding women
* Atrophic gastritis, open type
Abbott Laboratories Alinity s Blood Screening Assays - Clinical Evaluation Protocol

The objective of this study is to demonstrate the performance and intended use of each of the Alinity s investigational assays in a donor screening environment using clinical specimens to evaluate assay performance characteristics. A comparison of assay performance will be done versus the Food and Drug Administration (FDA) licensed assays. The data will be used to support regulatory submissions and/or publications.

This study evaluates Alinity s investigational assays using the Alinity s System. The Alinity s System is a high-volume, automated, blood-screening analyzer that is designed to determine the presence of specific antigens and antibodies by using chemiluminescent microparticle immunoassay (CMIA) detection technology. The system performs high-throughput routine and stat processing that features continuous access and automated retesting.

The Alinity s System is used for infectious disease marker testing in blood-screening and plasma laboratories for the following assays: Anti-HBc, Anti-HCV, HTLV I/II, Chagas, HBsAg, HBsAg Confirmatory and HIV Ag/Ab Combo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy donors who consented to participate in the study.

Exclusion Criteria:

* For testing with the Alinity s Chagas assay, exclude donors that have been screened on a previous donation using a licensed test for antibodies to T cruzi.

Note: A subject may participate at different times during the study for separate assay studies, but each subject should be represented only once for each assay.

The protocol does not define an age limit. A donor must be at least 17 years old to donate to the general blood supply, or 16 years old with parental/guardian consent, if allowed by state law.
One Week of Magnesium Supplementation Lowers IL-6, Perceived Pain and Increases Post Exercise Blood Glucose in Response to Downhill Running

This study investigated the effect of magnesium supplementation on exercise performance and functional recovery in recreational endurance athletes in conjunction with measures of blood glucose, lactate, IL-6 and sIL-6R.

Magnesium status can directly affect circulating glucose concentrations both during and post exercise. In addition, magnesium supplementation has been shown to reduce circulating IL-6 concentrations post exercise in humans. It is conceivable that such observations are linked through the role of IL-6 in glucose regulation, possibly in combination with sIL-6R. Together, magnesium intake may have the potential to effect exercise performance and recovery through glucose availability. This in turn may be connected to the production of IL-6 and sIL-6R which have been established to influence exercise fatigue and perception of pain (muscle soreness).

Eligibility Criteria:
Inclusion Criteria:

* Regular recreational runner, running around 3 times per week
* Capable of running 10 km in \~ 40 minutes.

Exclusion Criteria:

* Any signs or symptoms of cardiovascular issues.
* Any recent form of injury or illness.
* Currently, or in the last 3 months, have consumed multivitamin supplements
* Currently, or in the last 3 months, have consumed anti-inflammatory medications.
Severe Sepsis and Septic Shock Registry

The aim of this study is to construct multi-center sepsis registry that can be used for data warehousing and clinical research.

This registry prospectively enrolls adult patients with severe sepsis or septic shock in 21 tertiary hospital emergency departments.

Registered data can be used for quality control and clinical research to reduce sepsis-related mortality.

Eligibility Criteria:
Inclusion Criteria:

* two of more systemic inflammatory reaction syndrome criteria fever \> 38.3 'C or hypothermia \< 36'C, tachycardia over 90 bpm tachypnea over 20 per minute, leukocytosis (WBC over 12k/microL) or leukopenia (WBC below 4k/microL)
* suspected or proven infection
* any organ dysfunction as follows:

  1. cardiovascular (hypotension, systolic blood pressure \<90 mmHg, mean arterial pressure \<70mmHg)
  2. tissue hypoperfusion (lactate above upper limits laboratory normal)
  3. acute lung injury (PaO2/inspired oxygen fraction \< 250 in the absence of pneumonia, PaO2/inspired oxygen fraction \< 200 in the presence of pneumonia)
  4. acute kidney injury (Urine output \< 0.5mL/kg/hr for at least 2 hrs Serum creatinine \> 2.0 mg/dL)
  5. acute liver injury (Total bilirubin \> 2mg/dL)
  6. acute coagulopathy (Platelet count \< 100,000/μL or prothrombin time, international normalized ratio \> 1.5)

Exclusion Criteria:

* age less than 18 years old
* patients with cardiac arrest at presentation
* patients with advanced directives not to deliver aggressive organ supportive management
Nutrition Education Intervention in Adults With Type 2 Diabetes Mellitus in a Resource Poor Setting

The purpose of this study is to implement a nutrition education programme that was developed for type 2 diabetic adults in a resource poor setting and to evaluate the programme's effectiveness on health outcomes

A randomized controlled clinical trial study design will be used. One group (experimental group) will receive the nutrition education while the other group (control group) will receive the usual care.

Setting: Two Community health centres in Moretele Health Sub-District, North West Province, South, Africa

Effectiveness of the nutrition education will be evaluated for the following outcomes:

* clinical

  * blood sugar control based on HbA1c levels (primary outcome)
  * lipid profile (total cholesterol, low density cholesterol, high density cholesterol and triglycerides)
  * blood pressure
  * body mass index
* dietary intake
* others -diabetes knowledge, attitudes towards diabetes

Outcome measurements- at six and 12 months, this will be compared with the baseline data.

Hypotheses:

* the experimental group will have a significantly lower HbA1c compared to the control group
* the experimental group will have significantly better outcomes for dietary intake, blood lipid profile, blood pressure, body mass index, diabetes knowledge and attitudes towards diabetes and its treatment.

Type 2 diabetes mellitus (DM) is a global health challenge. Low-income individuals are among those observed to have poorer long term outcomes of diabetes management and to spend a higher proportion of their income on diabetes care. Therefore, diabetic individuals from resource poor settings require special attention and effective management strategies to assist them improve their health outcomes. Patient self-management education, including nutrition education is a feasible strategy in resource poor settings.

The nutrition education programme in this study is based on the target group assessed needs, as tailored education is shown to be more effective in improving health outcomes.

The experimental group will receive nutrition education in group format on a weekly basis for eight weeks, this will include a vegetable gardening component offered in collaboration with the Department of Agriculture. In addition written education materials will be provided (pamphlet and wall/fridge flyer). A follow-up intervention on a monthly basis will follow the group education.This is to revise the learnt content and for group problem solving activities. The control control group will receive usual care plus the written education materials.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* 40 to 70 years
* At least one year living with diabetes
* Blood sugar levels of 10mmol/L or above in at least two occasions in the last six months and consequent HbA1c levels of ≥8mmol/L
* Regular attendance of diabetic clinic

Exclusion Criteria:

* On insulin therapy
* Pregnant
* Full time employment
* Plans to move from study area during the study period