cyrilzakka/clinical-trials huggingface dataset:
Atopy Patch Test in Children With Food Allergy-related Gastrointestinal Symptoms

Positive reactions in Atopy patch test in children with food allergy-related gastrointestinal symptoms

The prevalence of food allergy seems to be increasing, which might explain the increased demand for reliable evaluation of patients with suspected food-related gastrointestinal symptoms. Little is known about the diagnostic accuracy of atopy patch tests(APT) in the clinical practice. APT seems to have a better specificity than the IgE methods and seems to reflect late-phase clinical reactions.The aims of this study were to evaluate:

(i) The prevalence of positive reaction of APTs for food allergy-related gastrointestinal diseases. (ii)Positive reaction of APT compare with skin prick test. (iii)Positive reaction of APT using lyophilized food vs commercially available food extracts. (iv)Side effect or adverse events of APT

Eligibility Criteria:
Inclusion Criteria:

* Patients who had history of suspected food allergy-related gastrointestinal symptoms eg. nausea and vomiting, diarrhea, abdominal pain or hematochezia after ingesting some food.
* Age 1 month-18 yrs
* Elimination diet was done at least 7 days before starting the study
* Written informed consent was obtained from the parents of each child enrolled in the study

Exclusion Criteria:

* Who have dermographism
* Who have chronic disease eg. autoimmune disease, immune deficiency, cancer or allergic disease
* Pregnant women
* Who have severe eczema
* Who receive antihistamine, topical steroid and systemic steroid \> 20 mg/day withiin 7 days prior study
Effect of Nutritional Support and Early Rehabilitation on Sepsis

Sepsis is a syndrome of life-threatening organ dysfunction caused by a dysregulated host response to infection.Acute catabolic response in critically ill patients struck by sepsis, manifested by massive protein breakdown in a short time.This pathology frequently leads to prolonged hospitalization and mechanical ventilation, increased mortality, and reduced quality of survival.It is uncertainty whether sepsis patients in ICU can benefit from high protein intake combined with early exercise. Even though the combination has been shown to be beneficial in other populations.In the present study, the investigator will evaluate the effects of a combination of high protein targets combined with early rehabilitation in sepsis patients in ICU.

Existing research results confirm that high target protein support can reduce the mortality of sepsis patients. Early bedside rehabilitation has a good effect on cognitive function after ICU. This study combined high-protein nutritional support with bedside rehabilitation to improve the quality of life in patients with sepsis after ICU.

Eligibility Criteria:
Inclusion Standard

1. Patients with sepsis
2. Patients aged 18-70 years
3. Time of admission ≤48 h
4. Non-terminal condition

Exclusion Standard

1. Severe acute kidney injury
2. Severe chronic liver disease (MELD score ≥20) or acute hepatic failure
3. Protein allergy
4. Pregnancy and lactation
5. BMI≥30 kg/m²
The WALK-Copenhagen Trial (WALK-Cph): a Mixed Methods Study

The WALK-Copenhagen project aims at enhancing physical activity during and after hospitalization in older medical patients by an intervention developed in co-operation with key stakeholders

In four phases we will develop (Phase 1), fidelity- and feasibility test (Phase 2), efficacy test (Phase 3) and adoption test the intervention (Phase 4). The project will use a combination of qualitative (Phase 1-4) and quantitative methods (Phase 2-3) and consists of two parallel tracks - WALK-Intervention and WALK-Implementation. Phase 1 of the study has been completed. Through workshops with patients, relatives, health professionals and researchers we have developped an intervention to enhance physical activity. Phase 2 will be carried out in October 2018 and January 2019 at Copenhagen University Hospital Hvidovre and in February 2019 at Copenhagen University Hospital, Frederiksberg. The developed intervention will be fidelity tested through daily observations at the wards. Also, the intervention will be feasibility tested in a prospective cohort study aiming at qualifying the intervention, testing recruitment strategies, testing patient willingness towards the intervention, testing randomization and blinding procedures and estimating an inclusion rate for Phase 3 (randomized controlled trial) to be conducted in 2019.

Update March 2019:

Due to a political decision to close down the medical ward at Copenhagen University Hospital, Frederiksberg in the spring of 2019, it was decided to change Phase 3 to a cohort study at Copenhagen University Hospital, Hvidovre. This decision was based on the fact that the methodological setup of the study (cluster RCT) was unintentionally changed due to the close down of one of the intervention wards.

Update November 2019:

Due to changes in characteristics of patients admitted to the intervention ward and thus a very slow inclusion rate in Phase 3 (Cohort Study), it was decided to terminate inclusion of patients. Qualitative data will still be collected as anticipated.

Eligibility Criteria:
Inclusion Criteria:

* +65 years
* acutely admitted to intervention wards
* able to walk independently with or without walking aid

Exclusion Criteria:

* in isolation
* inability to cooperate
* not able to speak or understand Danish
* in treatment for cancer
* terminally ill
* transferred to intensive care unit or another ward within 24 hours after admission
Study of Effectiveness of Lovastatin to Prevent Radiation-Induced Rectal Injury

Lovastatin may protect against late effects of radiation therapy in patients with prostate cancer

Oral lovastatin will be given at the dose of 20 mg/day with evening meal beginning on the first day of external beam radiation therapy (external beam alone or external beam followed by brachytherapy) or on the first day of brachytherapy (brachytherapy alone or brachytherapy followed by external beam radiotherapy) and continue for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
* Planned treatment with radiation therapy to include external beam and/or brachytherapy with curative intent (total dose ≥60 Gy). A portion of the rectum must receive at least 60 Gy.
* Age at least 18 years
* Karnofsky Performance Status (KPS) ≥ 70
* No history of prior radiotherapy to the prostate or rectum
* History of prior malignancy, if likely to live at least 4 years, is acceptable.
* No evidence of distant metastases
* Patients may be taking an HMG-coA-reductase inhibitor, but to be eligible, they must be able to be changed to lovastatin 20 mg/day, with the permission of their prescribing physician.
* Creatine kinase \< 5 times upper normal limit
* Sufficient renal function defined as calculated creatinine clearance ≥ 30ml/min
* transaminases \< 3 times upper normal limit

Exclusion Criteria:

* Planned abdomino-perineal resection after radiotherapy
* Contraindication to an HMG-coA-reductase inhibitor
* Major medical or psychiatric illness, which in the investigator's opinion, would prevent completion of treatment and would interfere with follow-up.
* Currently taking an inhibitor of cytochrome P450 3A4
* Active liver or muscle disease
PEG3350 Vs Senna After Urogyn Surgery

The goal of this study is to evaluate whether polyethylene glycol 3350 (PEG3350) versus senna is better at relieving postoperative constipation after urogynecologic surgery. The main questions it aims to answer are:

What number of patients taking PEG3350 have obstructed defecation syndrome (ODS), a form of constipation, vs those taking senna in the week after urogynecologic surgery? What patient-level and procedure-level characteristics are associated with postoperative ODS, in patients taking PEG3350 vs senna? participants will: Take their randomized medication daily for seven days after surgery Fill out an ODS questionnaire before and one week after surgery Complete a daily bowel diary for 7 days after surgery

The purpose of this study is to evaluate whether polyethylene glycol 3350 (PEG3350) versus senna is superior in the setting of postoperative constipation after urogynecologic surgery. This is a randomized controlled trial with the aim of comparing PEG3350 vs senna as postoperative recommended treatment for obstructive defecation constipation. Our hypothesis is that senna decreases the proportion of women with obstructive defecation constipation compared to use of PEG3350 after urogynecologic surgery. Women 18 years of age and older undergoing surgery for pelvic organ prolapse, stress urinary incontinence or both by the Department of Urogynecology at St. Joseph's Health Hospital, will be randomized to one of two study arms: senna or PEG3350. Arm 1: Polyethylene Glycol 3350, 17g, daily, oral. Arm 2: Senna (Sennosides) 8.6mg, 2 tablets daily, oral (up to 4 tablets twice a day). Interventions would be administered after surgery on postoperative day #0 and continue for 7 days total.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria includes women scheduled for urogynecologic surgery for pelvic organ prolapse and/or stress urinary incontinence and at least 18 years old.

Exclusion Criteria:

* Exclusion criteria include undergoing concomitant bowel surgery (colonic resection, anal sphincter repair, rectovaginal fistula repair, rectopexy) or placement of a sacral neuromodulation device alone.
Clinical Validation of An Optimized Multi-Target Stool DNA (Mt-sDNA 2.0) Test, for Colorectal Cancer Screening "BLUE-C"

The primary objective of this study is to assess the sensitivity for colorectal cancer (CRC) and specificity of the mt-sDNA 2.0 test.

Subjects 40 years of age and older scheduled for a screening colonoscopy will be enrolled. Subject will complete the mt-sDNA 2.0 test and the commercially available FIT, followed by completion of a screening colonoscopy. The results of the mt-sDNA screening test and FIT will not be provided to investigators for clinical management of the study subject. Personnel performing the colonoscopy and producing the resulting report and personnel performing histopathologial review of reports or tissue (if applicable) will remain blinded to the results of the mt-sDNA 2.0 screening test results.

Eligibility Criteria:
Inclusion Criteria:

Subjects must meet the following criteria to be eligible for the study:

1. Subject is ≥ 40 years of age at the time of enrollment.
2. Subject presents for a screening colonoscopy per standard of care.
3. Subject has no symptoms or signs that require immediate, or near term, referral for diagnostic or therapeutic colonoscopy.
4. Subject is able and willing to sign informed consent

Exclusion Criteria:

1. Subject has a history of CRC or advanced precancerous lesions.
2. Subject has a diagnosis or medical / family history of any of the following conditions, including:

   * Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
   * Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
   * Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
3. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
4. Subject has a diagnosis of Cronkhite-Canada Syndrome.
5. Subject has had a positive Cologuard within the previous 2 years, or fecal occult blood test or FIT within the previous 6 months.
6. Subject has undergone a colonoscopy within the previous 9 years with the exception of a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention.
7. Subject has had overt rectal bleeding within the previous 30 days.
8. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
GARDASIL Reexamination Study (V501-059)

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Gardasil through collecting the safety information according to the Re-examination Regulation for New Drugs.


Eligibility Criteria:
Inclusion Criteria:

* Females and males 9-26 years of age who Are Vaccinated With The First Dose Of Gardasil For The Prevention Of Any Disease Caused By Human Papillomavirus (e.g., Cervical Cancer, Genital Warts, etc.) Within Local Labeling

Exclusion Criteria:

* Participant Who Has A Contraindication To Gardasil According To The Local Label
* Participants Who Are Vaccinated With Gardasil Before Study Start
Tele-Electrocardiography in Emergency Cardiac Care

The purpose of this study is to see whether individuals who access the "911" emergency medical system with a heart attack or severe chest pain will receive more timely hospital treatment and better outcomes if hospital clinicians are provided with earlier and more complete electrocardiography (ECG) information.

This is a Phase III study. Patients will be randomized (like tossing a coin) to 1 of 2 groups: Group 1: Patients will have pre-hospital ECG intervention. Group 2: Patients will have routine emergency heart care. Information will be collected about time symptoms started, clinical management, and other measures. All patients will be contacted by telephone 12 months later and interviewed as to whether they experienced any cardiac symptoms.

Eligibility Criteria:
Inclusion Criteria:

* All individuals in Santa Cruz County in California who call 911 with symptoms of acute coronary syndrome (chest pain, shortness of breath, anginal equivalent).

Exclusion Criteria:

* Those who don't meet the above inclusion criteria.
Grocery Prescription Program for Medicaid Adults With Hypertension or Type 2 Diabetes

The purpose of this study is to evaluate the effectiveness of a grocery prescription program in adults diagnosed with either Type 2 Diabetes Mellitus or Hypertension. Participants will enroll in Instacart Fresh Funds program. Once enrolled each week participants will select foods that are eligible in the Fresh Funds Program to be delivered to their home for 12 weeks. Participants will also participate in a survey at the beginning of the study and at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Type 2 Diabetes Mellitus, hemoglobin A1c = 7.0% and = 12.0% in last 12 months, or diagnosis of hypertension
* Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
* English speaking
* No plans to move from the area for at least 1 year
* Willing and able to accept text messages
* Free living to the extent that participant has control over dietary intake
* Willing and able to provide written informed consent and participate in all study activities.

Exclusion Criteria:

* Participant in diabetes, nutrition, or weight research intervention in last 12 months
* Another member of the household is already enrolled in this study
* Considering bariatric surgery in the next year or prior bariatric surgery
* Lack of safe, stable residence and ability to store meals
Study With GFT505 (80mg) Versus Placebo in Patients With Type 2 Diabetes Mellitus

This study is expected to demonstrate the anti-diabetic efficacy of 3-months treatment with GFT505 (80 mg/d) on Glycosylated Haemoglobin A1c (HbA1C) and fasting plasma glucose.

And to assess the tolerability and safety of once-a-day administrations of oral doses of GFT505 for 12 weeks in patients with type 2 diabetes mellitus.

The study period per patient is 16-20 weeks maximum and is conducted as follows :

* Run-in period: 2 weeks or 6 weeks for patients under fibrate treatment at screening (4 weeks fibrate wash-out + 2 weeks placebo run-in);
* Treatment period: 12 weeks;
* Follow-up period: 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male or post-menopausal female (defined as \>12 months since last menstrual period) or surgical menopause. If hormonal replacement therapy, it should be stable at least for 6 months prior to screening.
* Body Mass Index ≥27 and ≤45 kg/m².
* Drug-Naive patients with type 2 diabetes mellitus (non insulin dependent diabetes). Patients should not be treated by insulin or other diabetes medication for the last 3 months prior to screening. Patients treated for less than 4 weeks with insulin may be included in the study.
* HbA1c ≥ 7.0% and \<9.5%.
* Antibody glutamate decarboxylase acid (Anti-GAD) negative for patients aged less than 40 years.

Exclusion Criteria:

* Type I Diabetes Mellitus.
* Blood Pressure \> 160 / 95 mmHg.
* Lipid-lowering drugs such as fibrates.
* Fasting Plasma Glucose (FPG) ≥ 240 mg/dL.
* Triglycerides (TG) \> 400 mg/dL.
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma

We hypothesize that simvastatin in combination with ICS might have synergistic anti-inflammatory effects on airway inflammation in asthmatic patients

To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum

Eligibility Criteria:
Inclusion Criteria:

* He or she has FEV1 \> 60% of predicted
* He or she requires less than 1000 mcg daily of beclomethasone or equivalent

Exclusion Criteria:

* He or she had previous history of renal disease or serum creatinine more than 2 mg/dL
* He or she had previous history of liver disease
* She is pregnant or during lactation
* He or she has already received statins or is allergic to statins or has developed myositis.
* He or she has an asthma exacerbation and requires treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.
Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms in Home Hospice

With the growth of hospice, older adults have the opportunity to receive home-based care aimed at reducing suffering and focusing on quality of life at the end of life. While use of technology and educational videos has yet to be fully developed, structured, and evaluated in home hospice care, it has shown promise to improve care in other settings. Therefore, this study aims to develop and evaluate a multi-component technology-based care intervention, i.e., Improving Home hospice Management of End of life issues through technology (I-HoME).

The study intervention focuses on assessing and addressing patient symptoms in the home hospice setting through weekly telehealth visits (for up to 6 weeks) and educational videos that are geared for the patient's informal caregiver. The aim of this phase of the project is two fold. One is that the study team will conduct a single armed (N=6 dyads) pilot study with a focus on optimizing data collection protocols and the intervention. After this step, a randomized pilot study evaluating the feasibility and potential efficacy of I-HoME (N=50 dyads) compared to usual care (N=50 dyads) will be conducted.

Phase I of the study to assess feasibility of the intervention was registered on ClinicalTrials.gov as NCT04074304.

Eligibility Criteria:
Inclusion Criteria:

Home hospice caregivers must be:

* English speaking
* 18 years of age or older
* not blind
* having a family member receiving home hospice care

Home hospice patients must be:

* English speaking
* 65 years of age or older
* not blind
* enrolled in home hospice care.

Exclusion Criteria:

* Patients with a terminal diagnosis of dementia or patients who have cognitive impairment and unable to sign a written informed consent will be excluded.
Viral Dynamics and Transmission of Influenza, RSV and SARS-CoV-2 in Children

Viral respiratory tract infections are very common in children. They contribute to missed time in school, work disruption for caregivers and can also cause severe illness requiring hospitalization and rarely death. In the 2022-2023, influenza, RSV and SARS-CoV-2 viruses infected a large number of children which strained the pediatric healthcare system in many jurisdictions. Unfortunately, there continues to be limited data on duration of infectiousness and transmission risk of these viruses to inform public health decisions during times when there is significant circulation of these viruses.


Eligibility Criteria:
Inclusion Criteria:

Viral dynamics (primary outcome):

* The child must be less than 18 years of age
* Have a positive PCR sample for influenza, RSV or SARS-CoV-2,
* Have any one of the symptoms listed to meet testing eligibility: fever, cough, shortness of breath, decreased or loss of taste or smell, muscle aches/joint pains (unusual, long lasting, not related to injury), extreme tiredness (unusual fatigue not otherwise explained), sore throat, runny or stuffy/congested nose, headache (new, unusual, long-lasting), nausea/vomiting and/or diarrhea, and
* Be within 5 days of symptom onset

Household testing inclusion criteria (secondary outcome):

-Any individual in the same household (i.e. household contacts, defined as residing at the same address) as the individual testing positive by PCR for influenza, RSV or SARS-CoV-2

Classroom testing inclusion criteria (secondary outcome):

-Any individual in the same classroom (i.e. classroom contacts) as the individual testing positive by PCR for influenza, RSV or SARS-CoV-2 (i.e. case identified through the THS program)

Exclusion Criteria:

Viral dynamics (primary outcome):

-Participants will be ineligible if they are more than 5 days from symptom onset
Post Marketing Surveillance of Remicade

The purpose of this study is to understand the safety and effectiveness of infliximab when used in clinical practice. This is a post-marketing surveillance study.

The investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Remicade approval.

Eligibility Criteria:
Inclusion Criteria:

* Severe active Crohn's disease: the patients with severe active Crohn's disease who do not show any response to the treatment with corticosteroid or immunosuppressive agents, have no drug tolerance, or are contraindicated to such treatments.
* Fistula-type active Crohn's disease: the patients with fistula-type active Crohn's disease who do not show any response to general treatments such as antibiotics, drainage, or immunosuppressant.
* Ankylosing spondylitis: the patients with ankylosing spondylitis who do not show adequate response to general treatments, and with increased serological indices related to severe axial symptoms and inflammation.

Exclusion Criteria:

* None