cyrilzakka/clinical-trials huggingface dataset:
Non-invasive Monitoring for Early Detection of Atrial Fibrillation

The aim of this project is to recognize the actual frequency of atrial fibrillation in the Polish population as well as to determine the independent risk factors for the occurrence of its clinically symptomatic and asymptomatic forms

The AF Survey is a cross-sectional observational study aimed to assess the prevalence and control of AF and its correlation with CVD risk factors in Poland, based on a representative sample of adults aged 65+. The main aim of the survey is to assess the prevalence, detectability and control of AF, heart failure, vascular diseases, arterial hypertension, stroke, sedentary lifestyle, smoking, lipid disorders, metabolic syndrome, obesity and diabetes, as well as other factors related to CVD risk such as chronic kidney and liver diseases, sleeping disorders, depression and selected psychosocial factors.

The assessment of AF prevalence with use of the monitoring system developed and validated during the first phase of the project, would be composed of a questionnaire, follow-up data sheet, blood pressure (BP) measurements and a blood sample collection.

The survey consists of three visits to subjects' homes (day: 1; 10+/-4 days and 30+/-4 days) and one phone contact one year after first visit and would be performed by trained nurses. The monitoring system would be installed during the first visit for all patients who sign informed consent form and returned at the third visit one month later. The main questionnaire will be completed during the first visit, which included detailed questions about present health status and history of diseases, hospitalizations, and current medications. The socioeconomic part of the questionnaire included questions concerning the personal and family situation, economic status, household structure, leisure activities, hobbies, and social life. During this visit the Geriatric scale of depression evaluation will be given to the subject to be self-completed, and will be collected at the second visit. BP readings would be taken three times during each visit to the patient's home. Anthropometric measurements are taken twice: at visit one and visit three at the end of the ECG monitoring. Blood samples are taken from subjects at the second visit after 10 to 12-hour fasting. The follow-up data sheet would be completed at the initial visit and at the follow-up visit twelve months after inclusion to the survey. The fieldwork is subcontracted to a company specializing in market research projects for the private and public sectors. The transportation of biological material to the Central Laboratory has been subcontracted to a company with expertise in blood sample transport over long distances. Interviewers will be recruited from among professionally active nurses. Most of them will be social nurses working within local communities. All nurses participating in the survey will complete special training prepared for fieldwork executors of the NOMED-AF project.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 65 years

Exclusion Criteria:

* age \< 65 years
Introduction of Arpraziquantel Treatment for Schistosomiasis Control in Preschool-aged Children in Endemic Areas: a Small-scale Public Health Intervention Study

The proposed small-scale pilot studies are public health intervention studies implemented through established routine programs and services in the frame of the mass drug administration (MDA) campaigns in Côte d'Ivoire, Kenya and Uganda. In each country two most promising health intervention platforms were selected for pilot distribution of arpraziquantel 150mg (arPZQ).

The aim of the small-scale pilot study is to assess the performance of different platforms for distributing arPZQ, a child-friendly formulation of praziquantel, to the target population (i.e., preschool-aged children (PSAC)) currently missed out in schistosomiasis treatment campaigns.

The specific objectives of the pilot study are:

* To assess the performance of different platforms for delivery of arPZQ to PSAC aged 24 to 59 months in terms of coverage, feasibility and acceptability
* To determine social mobilization and training needs for effective delivery of arPZQ through different platforms

Preventive chemotherapy with arPZQ will be offered systematically to eligible PSAC aged 2 to below 5 years of consenting caregivers resident in the study area and reached through the selected platforms. Adverse events during MDA with arPZQ will be documented and reported by using existing tools and established reporting pathways aligned with standard pharmacovigilance and safety guidelines of the national drug authorities. Based on routine program processes and forms, variables pertaining to drug logistics, training, drug distribution, passive pharmacovigilance and supervision will be collected in order to measure and generate real-world data related to feasibility, coverage and acceptability of selected platforms and strategies to inform future scale-up to district levels.

Assessments will take place before (to capture social mobilization and training activities) during and after the drug distribution to document the implementation process and evaluate experiences made by the different stakeholders (e.g. children, parents, community members, health workers, programme staff).


Eligibility Criteria:
* Living in the designated implementation area since at least 6 months
* Aged between 24 - 59 months
* Informed consent available
* No acute or chronic illness and/or inability to take oral medication
* No reported history of seizures
* No known allergic response to praziquantel
Paravertebral Block for Postoperative Analgesia in Children Undergoing Lateral Incision Cardiac Surgery With CBP

This study aims to compare the effect of paravertebral block and local infiltration anesthesia on postoperative analgesia in children undergoing lateral incision cardiac surgery with cardiopulmonary bypass. The researchers hope to investigate whether children who undergo paravertebral block experience less postoperative pain, have fewer postoperative complications, and recover more quickly.


Eligibility Criteria:
Inclusion Criteria:

1. Children aged 6-14 years old;
2. Children who have atrial septal defect or ventricular septal defect scheduled for lateral incision cardiac surgery with cardiopulmonary bypass;
3. Inform consent signed by the parent or legal guardian.

Exclusion Criteria:

1. Patients who were intubated, on mechanical circulatory support, or with intravenous inotropes before surgery;
2. Emergency surgery or redo cardiac surgery;
3. Body weight more than 50kg;
4. Diagnosed as severe pulmonary hypertension;
5. Left ventricular ejection fraction less than 45% in most recent echocardiography before surgery;
6. Allergic to ropivacaine or other regular anesthetics, analgesics or other medications regularly used in the study;
7. Preoperative platelet counts less than 100\*109/L, coagulopathy or bleeding tendency ;
8. Preoperatively using antiplatelets or anticoagulants;
9. Diagnosed with scoliosis or other contraindications for PVB.
68Ga Citrate PET/MRI for Evaluation of Fever of Unknown Origin (FUO)

This is a Phase III study to evaluate 68Ga Citrate PET/MRI for detection of origin of fever of unknown origin.

The purpose of this research study is to evaluate a PET tracer (68Ga-Citrate) that can localize the origin of patients diagnosed with fever of unknown origin (FUO) using a PET/MRI scanner. We hope to learn if this can detect FUO better than with the present nuclear imaging standard of care (67Ga SPECT).

We propose the following aim:

• To evaluate 68Ga Citrate PET/MRI for detection of origin of fever in patients with fever of unknown origin.

Patients disgnosed with fever of unknown origin are injected intravenously (IV) with 370 MBq of 68Ga Citrate. 45-60 minutes later, a whole body PET/MRI images are obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \>/=18 years old at the time of the scan.
* Patient with diagnosis of FUO.
* Patient is capable of complying with study procedures.
* Patient can remain still for duration of imaging procedure.
* Able to provide written consent.

Exclusion Criteria:

* Patient is pregnant or nursing.
* Metallic implants (contraindicated for MRI).
* History of renal insufficiency (only for MRI contrast administration).
* Inability to lie still for the entire imaging time.
* Inability to complete the needed investigational and standard of care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.).
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
* Known allergy, hypersensitivity, or intolerance to the investigational product or its excipients.
Self-directed Versus Therapist-directed Re-loading on Incidence of Ulcer Recurrence

This study is designed to evaluate if how people are told to return to walking after a skin injury affects whether or not they develop new (recurrence) skin breakdown on their feet. The people in this study will have diabetes and have a recently closed foot ulcer. About half will be specifically told how to return to walking and the other half will be told to return to walking slowly. How people naturally return to walking will also be established.

The purpose of this project is to determine the impact of Therapist-directed loading versus self-selected loading on ulcer occurrence and to establish natural loading behavior following diabetic foot ulcer closure.

Eligible participants will be randomized into a group given specific directions from a Therapist to return to walking (i.e. reloading skin following plantar ulceration closure) or a group encouraged to slowly return to walking (self-directed re-loading of the skin following plantar ulceration closure). Following randomization and instruction for re-loading according to group assignment, participants will be assessed every 6 months for walking behavior. Participants will be monitored for ulcer recurrence throughout. Participants will be followed for up to 18 months.

Eligibility Criteria:
Inclusion Criteria:

* With or without peripheral neuropathy
* Able to safely exercise
* Have a recently closed plantar ulceration

Exclusion Criteria:

* Presence of an open plantar ulceration
* Presence of an untreated infection
* Presence of osteomyelitis or gangrene
Evaluate the Auxiliary Diagnostic Value of Circulating Tumor Cells in Benign and Malignant Lung Nodules

By testing the CTC number of new solitary pulmonary nodule patient, evaluating the correlation of CTC number and benign and malignant lung nodules auxiliary diagnosis, the correlation of CTC number and the size of lung nodules of the malignant patients, the correlation between the CTC number and subtypes of malignant lung nodules patients.The CTC and tumor markers will be detected before the patient received treatment. Tumor markers include Pro-GRP, NSE, CEA, CYFRA211, SCC.


Eligibility Criteria:
Inclusion Criteria:

* New Solitary Pulmonary Nodule patients
* first visit patient
* Heart, liver and kidney function is normal.
* 18-80 years old.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Blood collection time is not in the scheduled time.
* The plasma sample hemolysis or condensation.
* Whole blood samples less than 3 ml.
* poor compliance
Reassessment of the Nutritional Status in Thai Orphans Living With HIV in a Family Style Community

To reassess nutritional status of HIV-infected Thai children living in the family style community after receiving nutrition support program for 6 months.

The first assessment indicated that improving dietary intake, either energy or micronutrient intakes, to meet the recommended for HIV-infected children (CLHIV) would be able to improve growth of these children. We implemented the nutrition support program through the two strategies aiming to increase dietary intake for all children to meet the current World Health Organization (WHO) recommendations which the recommended energy requirements are increased by10% for asymptomatic CLHIV and increased by 20 to 50% for children who require catch up growth or experiencing opportunistic infections. The nutrition support program composed two strategies. Firstly is providing nutrition education to caregivers and also children. Secondly, revision food menus by caregivers with assisting from the nutritionists of the project. After this program have been implemented for 6 months, reassessment is needed to evaluate the changes of nutritional status and health outcomes in this children aiming to further providing support and applying to other settings.

Eligibility Criteria:
Inclusion Criteria:

* Children age 4-15 years old
* Confirmed HIV-1 diagnosis
* Reside at the community
* The guardian must be able and willing to provide written informed consent. Oral consent in the presence of witness is acceptable in the case of illiteracy

Exclusion Criteria:

* non-HIV infected children
* Age 0-3 years
FLT-PET in Predicting Response to Chemotherapy in Patients With Advanced Malignancies

This clinical trial studies fluorine F-18 fluorothymidine (FLT)-positron emission tomography (PET) in predicting response to chemotherapy in patients with advanced malignancies. FLT solution can help locate cancer cells inside the body. Diagnostic procedures, such as FLT-PET, may help find tumors and measure a patient's response to treatment.

PRIMARY OBJECTIVES:

I. To determine if concurrent treatment with temsirolimus and bevacizumab demonstrates a dose-dependent decrease in FLT-PET standardized uptake value which correlates with clinical response.

SECONDARY OBJECTIVES:

I. To determine the relationship between FLT-PET and markers of angiogenesis and drug activity in tumor biopsy, along with surrogate peripheral blood markers of target inhibition and drug activity.

OUTLINE:

Patients undergo fluorine F-18 fluorothymidine PET at baseline, at day 6-8 of course 1, day 20 of course 2, and prior to day 1 of course 3.

Eligibility Criteria:
Inclusion Criteria:

* Patients actively enrolled and being treated on protocol 2007-0668: Combination Therapy with Bevacizumab and Temsirolimus in Patients with Advanced Malignancy at M.D. Anderson Cancer Center; these patients must have met the inclusion and exclusion criteria for that protocol
* Women of child-bearing potential (as defined as women who are not post-menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose
* Ability to understand and the willingness to sign a written informed consent document
* Patient actively enrolled and being treated on protocol 2012-0061 "A Phase I Trial of Bevacizumab, Temsirolimus Alone and in Combination with Valproic Acid or Cetuximab in Patients with Advanced Malignancy" at M.D. Anderson Cancer Center

Exclusion Criteria:

* Pregnant or breast-feeding women
* History of hypersensitivity to 3'-deoxy-3'-18F-fluorothymidine (18F-FLT) or any component of the formulation
A Study of Azilsartan in Children from 6 to Less Than 16 Years Old with High Blood Pressure

The main aim of this study is to check for side effects from treatment with azilsartan and how well azilsartan controls blood pressure in children from 6 to less than 16 years old with high blood pressure.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants with high blood pressure will take azilsartan tablets or azilsartan granules once a day according to their clinic's standard practice. The study doctors will check for side effects from azilsartan for up to 12 months after treatment starts.


Eligibility Criteria:
Inclusion Criteria

1. Participants aged 6 years or older and less than 16 years
2. Participants with hypertension

Exclusion Criteria Participants with contraindications to azilsartan.
Femoral Versus Psoas Continuous Peripheral Nerve Blocks Following Hip Arthroplasty

The purpose of this research study is to determine if the insertion site of a perineural catheter, or tiny tube placed next to the nerves that go to the hip which you will have surgery, affects the amount of pain relief that is experienced after surgery.

To determine the association between perineural catheter location and postoperative analgesia, analgesic requirements, ambulatory distance, and flexion following hip arthroplasty.

Primary Hypothesis: Differing the catheter insertion site (femoral vs. psoas compartment) for a perineural local anesthetic infusion is not associated with lower pain scores during the 24-hour period beginning the morning following hip arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* primary, unilateral hip arthroplasty or hip resurfacing
* age greater than or equal to 18 years
* postoperative analgesic plan includes perineural local anesthetic infusion

Exclusion Criteria:

* morbid obesity (BMI greater than 40)
* chronic, high-dose opioid use
* history of opioid abuse
* pregnancy
* incarceration
* amu meirp-muscular deficit of the ipsilateral femoral nerve and/or quadriceps muscle
* inability to communicate with hospital staff
68Ga-DOTATOC for Imaging of Neuroendocrine Tumors: Expanded Access Trial

The purpose of this study is to use a new type of scan, called 68Ga-DOTATOC PET/CT scan, instead of OctreoScan, the standard scan, to diagnose, monitor and manage your tumor. 68Ga-DOTATOC is an improved imaging agent being routinely used in many centers outside the USA, with better tumor detection than with OctreoScan.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed or suspected NET requiring 111In-pentetreotide imaging for clinical indications.
* High risk of NET because of familial predisposition with clinical findings requiring radiolabeled somatostatin imaging.
* Other somatostatin positive tumor for which 111In-pentetreotide has been used successfully (for example adult meningioma).
* Ability of subject or Legally Authorized Representative (LAR) (if the patient is deemed by the treating physician to be cognitively impaired or questionably impaired in such a way that the ability of the patient to give informed consent is questionable) to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Pregnant or lactating women: Pregnant women are excluded from this study because the effects of 68Ga-DOTATOC in pregnancy are not known; exceptions may be performed if expected risk outweighs the benefit. Pregnancy testing will follow MITS procedure for diagnostic reagents. Patients self report pregnancy status. If pregnant the test will not be performed unless in the clinical opinion of the attending physician the gain of the test is likely to outweigh the risk (this will be rare). If unsure whether pregnant or not then a urine or serum pregnancy will be performed.
* Because there is an unknown but potential risk for adverse events in nursing infants secondary to administration of 68Ga-DOTATOC in the mother, breastfeeding should be discontinued for at least one day if the mother receives 68Ga-DOTATOC.
* Patients that have contraindications for 111In-pentetreotide.
* Known severe allergy or hypersensitivity to oral contrast will preclude administration of such contrast (will preclude receiving oral contrast only).
* Patients with a body weight of 400 pounds or more or not able to enter the bore of the PET/CT scanner due to BMI, because of the compromise in image quality with CT, PET/CT and MRI that will result.
* Any additional medical condition, serious intercurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder

The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 18 to 40 kg/m2
* Subjects with bipolar I disorder who are clinically stable on a stable dose of at least 100 mg lamotrigine for at least 4 weeks prior to study entry
* Men and women, ages 18 to 65

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Patients with any significant acute or chronic medical illness, other than bipolar I disorder
* Subjects with active psychotic symptoms
* History of head trauma within the past 2 years
* History of akathisia requiring treatment
* History of tardive dyskinesia or abnormal involuntary movements
* Subjects with a predisposition to orthostatic hypotension
* Positive urine screen for drugs of abuse
* Use of narcotic-containing agents, amphetamines, or hormonal contraceptives within 4 weeks of study start
Effect of Adding Interferential Current to Pelvic Floor Muscle Training on Vaginismus

This study aims to determine the effect of adding interferential current to pelvic floor muscle training on vaginismus.

Vaginismus is a common sexual problem with a prevalence of 20% in Egyptian women, that has a significant impact on a person's life, affecting their physical, emotional, and psychological well-being, as well as their relationships and overall quality of life.

There were previous studies that studied the effect of pelvic floor rehabilitation on vaginismus and found that there was a highly significant decrease in pain and pelvic floor muscle spasms, as well as a highly significant increase in sexual function. Also, only one previous protocol explored the effect of interferential current on treating vaginismus. But, till now, there is no prior study that investigated the impact of adding interferential current to pelvic floor muscle training on treating vaginismus. this trial has two groups; one will receive interferential current, and the other group will receive interferential current + pelvic floor muscle training

Eligibility Criteria:
Inclusion Criteria:

1. Women suffer from primary vaginismus with a duration of marriage ranging from 1 to 12 months. They are diagnosed and referred by the gynecologist.
2. Their pain level is ≥ 4 on the visual analogue scale.
3. They have a sedentary lifestyle.

Exclusion Criteria:

1. Vaginismus requiring surgical treatment.
2. Any gynecological diseases such as pelvic organ prolapse, vulvar vestibulitis, vulvar pain, clitorodynia, vulvar dysesthesia, or any pelvic inflammatory diseases.
3. Lower urinary tract infection.
4. Husband with sexual dysfunction that prevents penetration.
5. Diseases involving nerves and muscles, such as myasthenia gravis.
6. Severe psychiatric disorder or cognitive relegation.
Newborn Screening Assay of Pompe's Disease

The purpose of this study is to test the feasibility of a newborn screen assay for Pompe disease

DBS from newborn will be tested for acid alpha-glucosidase (GAA) activity. Babies with low GAA activity will be confirmed for Pompe disease.

Eligibility Criteria:
Inclusion Criteria:

* newborns receiving newborn screening in Newborn Screening center of National Taiwan Univeristy Hospital
* parents signed inform consent for this study

Exclusion Criteria:

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