cyrilzakka/clinical-trials huggingface dataset:
Prevention of Respiratory Infections and MAnagement Among Children (PRIMAKid)

The PRIMAKid trial is a general practice based double-blind randomized placebo-controlled trial on the effectiveness and costs of combined influenza and pneumococcal vaccination in pre-school children with recurrent respiratory tract infections. A target number of 660 children aged 18-72 months with a history of two or more general practitioner attended episodes of RTI, are included. Exclusion criteria are diseases accompanied by a high risk of recurrent RTI and conditions chronically treated with corticosteroids. Over a period of 7 to 22 months follow-up, the number of febrile RTI-episodes as primary outcome is assessed, and as secondary outcomes the severity and length of febrile RTI-episodes, medical visits / interventions, health-related quality of life and productivity loss of parents.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-72 months
* A history of two or more episodes of general practitioner attended RTIs

Exclusion Criteria:

* No intention to move within 12 months to another region
* Provision of informed consent
* Good mastering of the Dutch language
* Absence of chronic diseases such as asthma treated with corticosteroids or high-risk disease (such as palatoschisis, Down syndrome, cystic fibrosis, etc.)
* No previous influenza vaccination or pneumococcal vaccination or Hepatitis B vaccination
* No hypersensitivity to eggs and/or antibiotics, and/or serious history of serious adverse events through vaccination
Evaluation of Dental Maturation and Mandibular Bone Morphology in Childhood Rheumatic Diseases

The aim of our study is to examine possible disease-related changes in dental age and mandibular bone morphology in childhood rheumatic diseases.

to reveal the changes that can occur in different childhood rheumatic diseases, the treatment process of the disease and the drugs used on the dental age and mandible

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 6 to 14 years with childhood rheumatism
* Patients without bilateral congenital germ deficiency in the lower teeth
* Patients with seven teeth (except no #8) on the left of the mandibula (No seven teeth on the left of the mandibula, there should be a symmetrical tooth on the right of the mandibula.

Exclusion Criteria:

* Patients with bilateral congenital germ deficiency in lower teeth in intraoral and/or radiographic examinations
* Patients with asymmetry and magnification errors and where anatomical structures cannot be seen clearly in the panoramic x-ray
* Patients with a significant number of missing teeth due to trauma or disease, root canal treatment, and pathological tooth structure
* Patients with a history of other chronic diseases
Exercise Training in Patients With Persistent or Permanent Atrial Fibrillation

The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive findings are vitally important for these patients, given the condition's substantial morbidity, mortality and high economic costs.

Recommended standards of care do not include the prescription of exercise to target and ameliorate the progressive health decline and overall feeling of well-being in patients with atrial fibrillation. Recent Standards for the Provision of Cardiac Rehabilitation of Ontario are calling for the consideration for referral and enrollment of patients with atrial fibrillation in cardiovascular rehabilitation - evidence is needed to support and confirm these efforts. The main purpose of this project is to evaluate the effects of high-intensity interval training (HIIT) compared to moderate-intensity continuous exercise training (MICE) and standard care on exercise capacity and quality of life in patients with persistent or permanent atrial fibrillation. Positive results from this study will identify a new intervention that: produces important improvements in patient-rated clinical, behavioural and exercise outcomes; provides mechanistic insight into the role of exercise training in the management of atrial fibrillation; requires minimal equipment; and, is appealing to patients with atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

1. persistent or permanent atrial fibrillation;
2. rate controlled with a resting ventricular rate of equal to or less than 100 bpm;
3. able to perform a symptom-limited exercise test;
4. at least 40 years of age (i.e. participants must be 40 years or older);

Exclusion Criteria:

1. currently participating in routine exercise training (more than two times per week);
2. unstable angina;
3. diagnosed severe mitral or aortic stenosis;
4. diagnosed hypertrophic obstructive cardiomyopathy with significant obstruction;
5. pregnant, lactating or planning to become pregnant during the study period;
6. unable to provide written, informed consent, or
7. unwilling or unable to return for follow up at week 12.
Doxorubicin, Cisplatin, 5-Fluorouracil in Patients With Advanced Adenocarcinoma of the Stomach or Esophagus

The purpose of this study is to collect information on the anti-tumor activity of the combination doxorubicin, cisplatin, and 5-fluorouracil when given to patients with advanced esophageal or gastric adenocarcinoma. We will also be collecting information about the side effects and safety of this combination.

* Patients will receive cisplatin and doxorubicin intravenously once every 3 weeks. In addition to cisplatin and doxorubicin, patients will receive 5-fluorouracil intravenously as a continuous infusion for the duration of the study. In order to do this, patients will receive an infusion pump that can be carried with them. Treatment cycles will be repeated every 21 days for a maximum of 8 cycles.
* Prior to enrollment in this study and while the patient is receiving the therapy, routine blood tests and x-ryas (including chest x-rays and CT scans) will be performed to check the body's response to the treatment. Blood tests will be checked once a week and chest x-rays and CT scans will be checked every 6 weeks.
* Patients with progressive disease or intolerable side effects will be removed from the study. Patients with stable disease or tumor response will continue therapy for a maximum of 8 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Measurable, locally unresectable or metastatic adenocarcinoma of the stomach, GE junction or esophagus
* No more than one prior chemotherapy regimen
* ECOG performance status of \< or equal to 2
* Life expectancy \> 12 weeks
* ANC \> 1,500/mm3
* Hemoglobin \> 9.0 gm/dl
* Platelets \> 100,000/mm3
* SGOT \< 3 x ULN
* Total bilirubin \< 2.0 mg/dl
* Creatinine \< 1.5 mg/dl

Exclusion Criteria:

* Prior cisplatin or doxorubicin as neoadjuvant or adjuvant therapy with in 1 year of study entry
* Clinically apparent central nervous system metastases or carcinomatous meningitis
* Myocardial infarction in the past 6 months
* Major surgery in the past 2 weeks
* Uncontrolled serious medical or psychiatric illness
* Pregnant or lactating women
* Concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* History or clinical evidence of congestive heart failure
Intranasal Ketamine for Late-Life Depression and Suicidal Ideation

The investigators of this study plan to investigate the feasibility and efficacy of repeated doses of intranasal ketamine in severely depressed patients who are at least 65 years of age and experiencing suicidal ideation. The results of the study could lead to development of new strategies for treating depression.


Eligibility Criteria:
Inclusion Criteria:

1) be ≥65 years old, 2) provide written informed consent, 3) meet criteria for a primary psychiatric diagnosis of major depressive disorder according to the Structured Clinical Interview for DSM-IV (SCID) and have a HDRS28 total score ≥20; depression may have started at any time point in their life, and certain co-morbid diagnoses (e.g., anxiety disorders) will be allowed insofar as they are not the primary psychiatric diagnosis, 4) have a history of ≥2 failed medication trials during the current episode (per the Massachusetts General Hospital Antidepressant Treatment History Questionnaire; MGH ATRQ), 5) endorse suicidal ideation for more than 2 months, per the Columbia Suicide Severity Rating Scale (C-SSRS) and have a HDRS28 suicide item score ≥1 (thoughts that life isn't worth living), 6) be on a stable antidepressant regimen for ≥14 days prior to Study Phase II, 7) maintain a treating psychiatrist who is in agreement with study participation, and 8) have a reliable chaperone accompany them home following the completion of the intranasal administration.

Exclusion Criteria:

* Patients will be excluded if any of the following criteria are met: 1) Delirium or dementia diagnosis, 2) unstable medical illness, 3) history of clinically significant cardiovascular disease or electrocardiogram (EKG) findings, or medical conditions that put the patient at risk for possible cardiac side effects, 4) history of multiple adverse drug reactions, 5) current/past history of psychotic disorders or homicidality, 6) active substance use disorders (except nicotine and caffeine) within the past six months, positive urine toxicology screen, or past history of ketamine abuse, 7) requirement of excluded medications (narcotics, barbiturates, theophylline, or St. John's Wort), or 8) concurrent or recent participation in other research studies.
Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy

Patients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (RC). The aim of the study is to investigate the effect of perioperative Comprehensive Geriatric Assessment (CGA) and tailored intervention in older, frail patients with bladder cancer undergoing RC.

Patients will be randomized 1:1 and allocated into either control or intervention study arm. The control group will receive perioperative "care as usual" according to exciting principles and guidelines. The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with muscle-invasive bladder cancer and scheduled radical cystectomy.
2. Planned urinary diversion with an ileal conduit
3. Age ≥ 65 years.
4. Patients considered frail by G8 screening tool (total score ≤14).

Exclusion Criteria:

1. Patients who refuse or are not able to provide informed consent.
2. Patients who do not speak or understand Danish.
3. Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC
Partial Breast Irradiation for Low-risk Ductal Carcinoma In Situ After Breast-conserving Surgery

This study is designed to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Randomized clinical trials have demonstrated that the recurrence of DCIS is low and most of the recurrence occurs around the tumor bed. Besides, cosmetic outcomes are reported better in partial breast irradiation group compared to whole breast irradiation group. However, whether or not partial breast irradiation is safety in DCIS is still unknown. The purpose of this study is to evaluate the feasibility and safety of partial breast irradiation for low risk DCIS after breast-conserving surgery.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18\~65 years old
* Pathologically confirmed DCIS, low- or intermediate- grade DCIS: (lesions of ≤2.5 cm diameter, resection margins of at least 3 mm, nuclei grade: 1-2), high grade DCIS: (lesions of ≤1 cm diameter, resection margins of at least 3 mm, nuclei grade: 3)
* Treated with breast conserving surgery
* Tumor bed is labeled with Titanium clips
* No malignancy history
* ECOG score 0\~1
* Written informed consent

Exclusion Criteria:

* DCIS of both breast
* invasive breast cancer
* Multicentric disease
* Patients underwent mastectomy
* Previous radiation therapy of breast
* Medical contraindication for radiotherapy
* Pregnant or nursing
* suspicious calcification after surgery
Multi-marker INDex for the Risk Assessment of Sepsis in the Emergency departmenT (MINDSET)

The purpose of the study is to procure blood samples from patients ≥18 years of age who present to the Emergency Department (ED) with at least two of the diagnostic criteria for sepsis. Samples obtained upon enrollment will be used for future testing of the Triage Sepsis Panel and other biomarkers.

This is a multi-center, prospective specimen procurement study. The samples will be used for future testing of the Triage Sepsis Panel in conjunction with other laboratory tests and clinical assessments as an aid in the assessment for risk of sepsis progression within 72 hours of patients presenting in the Emergency Department and meeting the diagnostic criteria for sepsis who might be considered for hospital admission, including to the ICU. Approximately 700 patients presenting to the Emergency Department (ED) with at least two of the symptoms or signs of sepsis will be enrolled in this study.

The day of enrollment is defined as Study Day 0. Enrolled patients who are discharged to home will be contacted by telephone on Study Days 3, 14 and 28 to assess their clinical status.

Patients who are admitted to the hospital following initial enrollment will undergo the following assessments at 24, 48 and 72 hours after enrollment and at discharge (if in the hospital and alive at these time points).

Each patient will also be contacted on Study Day 14 and on or after Study Day 28 to assess the duration of hospital stay and mortality through Days 14 and 28.

Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age or older
* Presenting to the emergency department (ED) for evaluation and who can be enrolled within 6 hours of initial ED evaluation
* Exhibiting two or more of any diagnostic criteria for sepsis
* Willing and able to comply with study procedures, including follow-up telephone contact (or in-house assessment) on Study Days 3, 14, and 28

Exclusion Criteria:

* Age \< 18 years
* Participation in any interventional clinical study within the previous 30 days
* Status-post cardiac arrest (within the past month)
* Moribund or with active "Do Not Resuscitate" or "Comfort Care Only" status
* Prisoners or other institutionalized or vulnerable individuals
* Already a hospital in-patient
* Unwilling or unlikely to comply with study procedures or to be reachable by telephone (or in person) for Day 3, 14, and 28 status assessments if discharged
Ribomustin in the First Line Therapy of Chronic Lymphocytic Leukemia

Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic lymphocytic leukemia (CLL) with current or planned first line therapy with Ribomustin
* Informed Consent Form for personal data handling signed by the program participant

Exclusion Criteria:

* Any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of CLL
* Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment
* Contraindications for Ribomustin usage in accordance with product label
Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on one topical hypotensive medication

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled
Study of Programm Interest 'Bouge' to Improve the Daily Physical Activity at the Pregnant Women.

Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of pregnant patients beguining at 15 SA

Controlled, randomized, open, prospective, multicentric study, 250 pregnant patients aged between 18 and more, with 14 weeks of amenorrhea, possessing a smartphone, will be recruited and randomized into two groups:

125 in the control group (smartphone application "placebo" = number of steps) 125 will be equipped with the application "Bouge" = coached group

For three months, the patients do their daily physical activity. The "coached" group, through the smartphone application "Bouge", receives computer coaching to increase their physical activity (no direct medical intervention, only notifications and computer pusch).

The control group is not coached by the application (simple display of the number of step)

Eligibility Criteria:
Inclusion Criteria:

Pregnant \<14 weeks of amenorrhea Must have a compatible smartphone

Exclusion Criteria:

Multiple pregnancies Pre-existing pregnancy-related diseases Pregnancy complicated History of peripheral arterial disease History of IUGR History of cone biopsy History of delivery hemorrhage
Recruitment and Behavioral Economic Strategies

To determine the impact of the application of behavioral economic strategies on recruitment of pediatric patients into a randomized clinical trial assessing the impact of technology-based interventions on postoperative pain management.

Patients will be asked to watch one of two videos in either Phase 1 or Phase 2 relating to recruitment and fill out a survey to determine their likelihood to enroll in a research study. Patients 12-18 years of age presenting for surgery that requires postoperative admission and usually requires narcotic administration.

Eligibility Criteria:
Inclusion Criteria:

* Patients between the ages of 12-18 years of age
* Patients able to read, understand, and speak English
* Patients undergoing surgery requiring postoperative admission
* Patients undergoing surgery that requires narcotic administration

Exclusion Criteria:

* Patients outside of the age range
* Patients with history of developmental delay, uncontrolled psychiatric conditions, or neurological conditions (i.e., epilepsy, motion sickness, nausea/vomiting)
* History of severe vertigo or dizziness
* History of chronic pain
* Patients that use opioids or benzodiazepines chronically
* Patients with conditions that would preclude placement of a VR headset, including craniofacial abnormalities or undergoing surgeries of the head and neck.
Alleviant ALLAY-HFrEF Study

Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.


Eligibility Criteria:
Inclusion Criteria:

* LVEF ≤ 40%
* NYHA class II, III or ambulatory IV HF
* Receiving optimal, maximally tolerated, stable GDMT

Exclusion Criteria:

* Advanced heart failure
* Life-expectancy \< 12 months
* Evidence of right heart dysfunction
ROADSTER 3 Extended Follow-up Sub-Study

The study objective is to evaluate long-term outcomes for participants enrolled in the ROADSTER 3 study and treated with the ENROUTE Transcarotid Stent System (TSS) and ENROUTE Transcarotid Neuroprotection System (NPS).

This is an open label, single arm, multi-center post-market study evaluating long-term outcomes for participants at standard risk for adverse events from carotid endarterectomy who underwent carotid revascularization with the ENROUTE Transcarotid Stent System and the ENROUTE Transcarotid Neuroprotection System in the ROADSTER 3 study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who were enrolled in the ROADSTER 3 study and treated with the ENROUTE TSS and ENROUTE NPS
* Able to provide informed consent

Exclusion Criteria:

* Participants who have exited the ROADSTER 3 study early (i.e., prior to completion of protocol required follow-up) will not participate in the sub-study
Comparison of Mortality Among HDU Patients With Modified Early Warning Score Cutoff of 5

Early categorization of critically ill patients by calculating MEWS score in hospitals may give a time window for appropriate steps. If a patient is suffering from sepsis, timely intravenous fluids, early antibiotics and monitoring in a low resource country like Pakistan, may have a great impact. Therefore, the current research is planned to early identify critically ill patients by applying MEWS and reducing the mortality by providing early management and taking appropriate life saving measures.

Objective: To compare frequency of mortality on 7th day of admission in HDU patients with Modified Early Warning Score at the time of admission of \< 5 \& ≥ 5.

Early recognition and immediate resuscitation are fundamentals of successful management of all critically ill patients if they are suffering from infection and sepsis, malnutrition, AIDS, trauma, diabetes mellitus, drug overdose, and poisoning. In most, seriously ill patients, initial diagnosis may not be clear and immediate objective is to save the life and reverse or prevent vital organ damage e.g. brain, lungs, liver and kidneys. A rapid identifying, low cost method called as Modified Early Warning Score (MEWS) that utilize easy to measure physiological parameters such as vital signs and level of consciousness can be used to identify critical illness, facilitate early intervention and predict mortality. MEWS values range from 0 to maximum 14, higher scores mean greater hemodynamic instability. A score of 5 or more identifies a patient to be critically ill and is associated with increased risk of ICU admission and death. The negative predictive value of early warning MEWS \< 3 was 98.1%, indicating the reliability of this score as a screening tool MEWS (modified early warning score) is a reliable screening tool to identify critically ill patients early and to act timely to improve outcomes in health care and prevent adverse events like cardiac arrest, renal failure. A study performed in Uganda on sepsis patients demonstrated that early IV fluid and antibiotic therapy together with vital sign monitoring was associated with lowered 30-day mortality.

Rationale: Early categorization of critically ill patients by calculating MEWS score in hospitals may give a time window for appropriate steps. If a patient is suffering from sepsis, timely intravenous fluids, early antibiotics and monitoring in a low resource country like Pakistan, may have a great impact. Therefore, the current research is planned to early identify critically ill patients by applying MEWS and reducing the mortality by providing early management and taking appropriate life saving measures.

Eligibility Criteria:
Inclusion Criteria:

* admitted in high dependency unit (HDU) of Medical Unit-II

Exclusion Criteria:

* Neurosurgical trauma clinically assessed
* Orthopedics or general surgery trauma patients clinically assessed
* Obstetrics patients clinically assessed