cyrilzakka/clinical-trials huggingface dataset:
Factors Affecting Adherence to Anti-HIV Drug Regimens in Children and Adolescents

Taking anti-HIV medication consistently and properly is a critical issue for patients with HIV. Drug regimens are complex; when regimens are not taken properly, HIV can become resistant to the drugs. Taking anti-HIV medication properly leads to improved health. Children and adolescents with HIV face unique challenges to taking HIV medication properly. This study will look at the relationship between how children cope with the responsibility for taking medication and the child's language, memory, attention, behavior, and academic skills. This study is open to children and adolescents who are currently enrolled in the PACTG 219C study (Long-Term Effects of HIV Exposure and Infection in Children).

Medication adherence is a critical issue for HIV infected children and adolescents because of drug resistance and the increased complexity of treatment regimens. Children and adolescents with HIV face depression, anxiety, denial, and rebellion that may interfere with their motivation to take medication. Depression and self-perceived social support have been found to predict regimen adherence in adults with HIV. Children with other chronic diseases are less likely to adhere to their medication regimens if they also have behavioral or emotional problems; assessing emotional and behavioral function in children and adolescents with HIV may help in predicting adherence and explaining adherence failure. This study will correlate cognitive, behavioral, and psychosocial functioning with measures of virologic suppression and immunological status, and it will compare self-report and pill count measures of adherence in a randomly selected subset of perinatally infected HIV participants of PACTG 219C.

Children and adolescents currently enrolled in PACTG 219C will be randomly selected for this study, which will last for 48 weeks. At entry, participants will undergo neuropsychological evaluation, including academic achievement, attention, memory, language comprehension, and behavior assessments, and complete a health beliefs questionnaire. Both the participants and their parents or primary caregivers will complete questionnaires at study entry and Weeks 24 and 48. Adherence will be evaluated from self-reported and pill count measures (Weeks 4 and 24) and the PACTG 219C Adherence Module (Weeks 24 and 48).

Eligibility Criteria:
Inclusion Criteria

* HIV-1 perinatal infection
* Already enrolled and in active follow-up in PACTG 219C
* Can communicate in English or Spanish
* On antiretroviral medication regimen at the time of enrollment, regardless of compliance with regimen, with no planned treatment interruptions

Exclusion Criteria

* Acquired HIV via routes other than perinatal transmission or source of HIV infection is unknown
* HIV-2 infection
PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome

The PREPPeD study proposes that predelivery placenta-derived maternal circulating biomarkers reflect placental health, capacity and ageing, and can help predict onset and complications of delivery both in complicated pregnancies as well as in clinically uncomplicated term/post-term pregnancies.

The main aim of the PREPPeD study is to explore whether placental health, evaluated by maternal blood biomarkers in late pregnancy, correlates with delivery outcomes in both healthy and complicated pregnancies.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women scheduled to deliver at the Department of Obstetrics at OUH who qualify for the study groups as specified in the "Groups and Intervention" section.

Exclusion Criteria:

* Women who do not understand Norwegian or English
* Communicable disease
* Younger than 18 years of age
* Legally incompetent
* Fetal malformations
Blood Screening for Adult Colorectal Cancer

Multicenter, inter-regional, case-control study with the primary objective of evaluating the discriminative power of the blood biomarker TFPI-1 to separate patients with histologically proven CRC from an asymptomatic control population between 50 and 75 years of age with normal colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected colorectal cancer for which colonoscopy is indicated.
* Patients between 50 and 75 years old, asymptomatic from the digestive point of view (for example referred for colonoscopy as part of a pre-operative check-up of an inguinal hernia or 3 months after an episode of complicated sigmoiditis), for whom a follow-up colonoscopy is indicated.

Note.

* If the post-inclusion colonoscopy is normal, no biopsy will be performed and patients will be assigned to the control group.
* If the colonoscopy performed after inclusion is abnormal (presence of at least one mucosal lesion), patients will be assigned to the "colorectal cancer" group or to the "polyps" group depending on the results of the anatomopathological analysis of the lesion(s)

Exclusion Criteria:

* All clinical situations outside of CRC that could increase TFPI-1 or 2 blood levels: acute coronary syndrome (unstable angina, acute myocardial infarction), severe sepsis, decompensated cirrhosis, pregnancy, chronic inflammatory bowel disease (Crohn's or ulcerative colitis), colitis or radiation rectitis.
* Endoscopic polypectomy without prior histological confirmation.
* Emergency (occlusion or peritonitis)
* Minor patients.
* Persons of full age under legal protection or unable to express their consent
* Persons not affiliated to a social security system or beneficiaries of such a system.
* Pregnant women, women in labor or nursing mothers.
A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients

The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Adult aged from 18 years
2. Patients electively treated for rectal cancer with a low anterior resection
3. Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable
4. LARS score \>= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARS definition as consensus with at least one symptom that results in at least one consequence (Keane et al. 2020)
5. Adult for whom previous conservative treatments were started for at least a month
6. Mental and physical capability of the patient to handle the MiniGo by himself.
7. Check of the anastomosis (no signs of leakage or clinical relevant stenosis) and absence of local recurrence by Rectal digital examination of the anastomosis, any other exam used in the current practice
8. Patient affiliated to the health social security system

Exclusion Criteria:

1. Contra-indication to use TAI
2. Former use of TAI (post colo-rectal surgery)
3. Clinically relevant stenosis
4. Current metastatic disease or local recurrence
5. Ongoing chemotherapy
6. Postoperative radiotherapy for rectal cancer
7. History of diarrhoeal disease
8. Inflammatory bowel disease
9. Dementia
10. Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant disease assessed to be a contributory cause to LARS symptoms.
11. Patient with cancer recurrence
12. Patient with a life expectancy \< 1 year
13. Participating to another clinical trial for the treatment of LARS symptom
14. Ongoing pelvic floor rehabilitation/biofeedback
15. Pregnancy or intention to become pregnant during the trial period
16. Inability and unwillingness to give informed consent
Relationship Between the Functional Movement Screen and Isokinetic Muscle Strength of Knee in Different Sport Branches

This study was conducted to demonstrate the correlation between the functional movement screen and the isokinetic muscle strength with objective data. Investigators conclude that the use of FMS in combination with isokinetic systems will provide more detailed information on the prevention of injuries to sports and the improvement of performance.

This study was conducted to demonstrate the correlation between the functional movement screen and the isokinetic muscle strength with objective data. 60 athletes involved in volleyball, greco-roman, speed skating, athletics and taekwondo branches were included in the study. The functional movement of the athletes was assessed by Functional Movement Screening, lower extremity isokinetic muscle strength was assessed by ISOMED 2000® isokinetic device.

Eligibility Criteria:
Inclusion Criteria:

* Those who voluntarily agreed to participate in the study
* Have at least 3 years of licensed sports experience

Exclusion Criteria:

* Those who have had or have ongoing orthopedic problems in the last 6 months
Alpha-Synuclein PET/CT in Various α-Syn-Related Disease

To evaluate the potential usefulness of 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various α-Syn-related disease patients.

Subjects with various α-Syn-related disease patients underwent 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 PET/CT either for an initial assessment or for recurrence detection.

Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FIAT-2, 18F-C05-05, 18F-SPAL-T-06 PET/CT were calculated.

Eligibility Criteria:
Inclusion Criteria:

* (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated PD (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled α-Syn PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* (i) patients with none PD syndrome; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
The Comparative Study of OCT，Gemstone CT and 320-detector Row Spiral CT for Evaluating Restenosis of Coronary Artery Stent

In-stent restenosis is a major reason of coronary heart disease recurrence .Even in drug eluting stent(DES), Restenosis rate could be up to 10% in diabetes and complex lesions though it was about 3-5% in general. It is particularly important that in-stent restenosis after implantation was early diagnosed and detected. The evaluation of OCT imaging is more accurate for narrow area calculation, more clear for narrow organization structure and more specific for detecting tissue types.It is currently the best way for restenosis histologic diagnosis.But it has many weakness such as the higher cost,an invasive test, expensive instrument, relatively complicated to operate,and etc.In this study, OCT image was regard as the "gold standard" of stent restenosis.

The improvement of spatial resolution of Gemstone CT can effectively improve the imaging quality and the measurement's accuracy of coronary artery stents.The diagnostic value of in-stent restenosis of Gemstone CT is higher than of the 320-detector row spiral CT. To a certain extent, the gemstone CT can replace OCT for examining the in-stent restenosis.

This study will examine the degree of in-stent restenosis by the gemstone CT and the 320-detector row spiral CT and compare the two ways on the basis of the result of OCT.


Eligibility Criteria:
Inclusion Criteria:

1. Age 20-80， All genders
2. Unlimited time of implantation of coronary artery stents
3. Myocardial ischemia symptoms such as Chest tightness and/or chest pain in patients after stent implantation
4. No clinical symptoms, but myocardial ischemia suggested by other noninvasive tests
5. Routine re-testing 9-12 months after stent implantation.

Exclusion Criteria:

1. Renal insufficiency (serum creatinine \> 120 umol/L)
2. Allergy of contrast
3. Severe heart failure
4. Uncontrollable heart rate or contraindication of taking metoprolol
5. Unstable condition
6. the ventricular rate beyond 70 beats / min and irregular rhythm after adjusting.
Trial of Laparoscopic Cholecystectomy vs. Non-operative Treatment for Gallbladder Dyskinesia

The goal of this study is to challenge the existing clinical practice of employing laparoscopic cholecystectomy as the treatment for gallbladder dyskinesia by comparing it to a regimen of active non-surgical therapy.

Willing and eligible patients will be enrolled into the trial and randomized to surgical vs non-surgical treatment following informed consent. The following information will be collected over the next 18 months: age,race, sex, baseline and follow-up quality of life quationnaire scores, a complete medical history, including co-morbid illnesses, medications and surgical history, and a complete assessment of symptoms, including disease specific symptoms against the Rome III criteria for functional gallbladder disorder. Patients randomized to surgery will be referred for immediate laparoscopic cholecystectomy. Patients in the non-surgical management group will be counseled on maintenance of a low-fat diet, and provided with a prescription for amitriptyline 25mg once daily.

Patients with persistent, non responsive symptoms that fail to respond to at least one week of administration of amitriptyline will be allowed to voluntarily, cross over into the surgically treated group.

After randomization, certain data collection points will be unique to the two groups. These are as follows and are in addition to the general data which will be collected from both groups:

Surgery group: operative/pathology findings \& operative complications

Non-surgical group:

Patients will be asked to maintain a food diary and a symptom diary. Patients will be asked to report any medication related side effects.

Both groups will receive a phone call for assessment of conditions. Non-surgical groups will be asked to report any medication related side effects.

Follow-up for both groups will continue throughout the 18 month period. In addition to the monthly calls, Patients will be contacted every three months after their initial treatment to take the SF-8 questionnaire and obtain an assessment of symptoms using the Rome III criteria.

Eligibility Criteria:
Inclusion Criteria:

Patients with a normal gallbladder Patients with symptoms compatible with gallbladder dyskinesia (functional gallbladder disorder) as defined by the Rome III criteria Patients with a Cholecystokinin hepatobiliary (CCK-HIDA) scintigraphy gallbladder ejection fraction of \<38%, performed at a facility using updated Society of Nuclear Medicaine guidelines for test administration

Exclusion Criteria:

Patients with other known sources of chronic abdominal pain (ex: Crohn's disease) Patients with chronic narcotic use which will affect the reproducibility and validity of the CCK-HIDA results Patient with a history of allergy to amitriptyline Patients with a seizure disorder
Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis

Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic factors in oncologic surgery; however, the role of lymph node dissection remains unclear for colorectal cancer liver metastasis.

Lymph node status is a definite prognostic factor in oncologic surgery and significantly affects long-term survival, as reported by the tumor staging system of the International Union Against Cancer (IUCC), which is the most widespread classification of malignant tumors worldwide. Regional lymphadenectomy is already the standard procedure that completes hepatic resection in the case of carcinoma arising from the extrahepatic bile duct. However, the indication, extent, and role of lymph node excision are still a matter of discussion, and no clear guidelines exist in patients with colorectal cancer liver metastasis.

Eligibility Criteria:
Inclusion Criteria:

1. first hepatectomy;
2. age \<75 years;
3. absence of severe cardiovascular,pulmonary, or other associated diseases;
4. absence of other malignant disease;
5. absence of distant metastases secondary to colorectal cancer other than liver metastases (except a solitary peritoneal tumor that could be completely resected during hepatectomy); and
6. complete resection of liver metastases confirmed during surgery.

Exclusion Criteria:

1. HNPCC
2. FAP
3. patient who refuses perihepatic lymphadnectomy
4. medical condition in which surgery cannot be tolerated
Efficacy and Safety Study of Ticagrelor

The purpose of this study is to compare the efficacy and safety of ticagrelor with clopidogrel

180 elective percutaneous coronary intervention patients with clopidogrel resistance were randomized to three groups, Group 1:received clopidogrel 75mg qd ;Group 2:received clopidogrel 150mg qd ; Group 3:received ticagrelor 90mg bid after PCI.Platelet funtion were tested by flowcytometric vasodilator-stimulated phosphoprotein(VASP) analysis before PCI,and 3days,7days and 1 month after PCI,respectively.The aim of our study is to compare the efficacy and safety of ticagrelor with clopidogrel

Eligibility Criteria:
Inclusion Criteria:

* 1.Clinical diagnosis of ACS 2.undergoing PCI 3.with clopidogrel resistance

Exclusion Criteria:

* 1.any contraindication against the use of clopidogrel and ticagrel 2.Contradiction to aspirin and contrast medium 3.Life expectancy less than 1 year 4.Tumor or inflammatory diseases5. fibrinolytic therapy within 24 hours before randomization 6.a need for oral anticoagulation therapy 7. an increased risk of bradycardia 8.concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer 9.a history of asthma.
Bioequivalence Study of Sodium Divalproate Tablets 500 mg

The objective of this study is to establish the bioequivalence of two valproic acid formulations through the estimation of valproic acid in plasma samples, according to Food and Drugs Administration (FDA), World Health Organization (WHO) and Colombian National Vigilance Institute for Drugs and Food (INVIMA) guidelines.

This will be a single-center, open-label, four-period, two-treatment, two-sequence, randomized, single-dose, crossover study. 30 healthy adults will be randomized to receive a single dose (500 mg) of the test formulation of valproic acid and reference formulation of valproic acid separately in each treatment period. There will be two treatment sequences (AB, BA) and a 7 day washout between the two treatment periods.

Eligibility Criteria:
Inclusion Criteria:

* Men and Women from 18 to 50 years old
* Diagnosed as healthy after a clinical examination
* BMI from 18 to 30 kg/m2
* Not smoking for at least 3 months
* To sign the informed consent
* Not having participated in a similar study for at least 4 months

Exclusion Criteria:

* Renal, cardiac immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric condition
* Hematologic disorders, specially anemia and polycythemia
* Permanent or temporal pharmacological therapy, prescribed or not
* Smoking for the last 3 months
* Alcohol drinker more than once a week
* Drug abuse
* Drug hypersensitivity
* Angioedema or anaphylaxis history
* Pregnancy or breast-feeding
* HIV o Hepatitis B diagnosed
* Blood donor in the past 30 days
Short Term Effect of Empagliflozin in Hypertension

The investigators assessed the 6-week effect of once daily 25mg SGLT2-i Empagliflozin on left ventricular diastolic function and blood pressure profile in non diabetic hypertensive patients

Background: The rapid beneficial effects of Empagliflozin on cardiovascular mortality and hospitalizations rates for heart failure according to the Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) trial raise some question in the mechanism of myocardial action. The investigators conducted this study in a population of non-diabetic hypertensive patients in order to look for a short-term effect on left ventricular relaxation.

Methods: The investigators carried out a single arm non- randomized clinical trial and assigned patients to receive 25mg of empagliflozin once daily in additional therapy for six weeks at the National Center for Obesity and in the cardiology department of Yaounde Central Hospital in hypertensive patients with cardiac relaxation disorder. The objectives were to evaluate the left ventricular diastolic function and nycthemeral blood pressure profile.

Eligibility Criteria:
Inclusion Criteria:

* Grade 1 hypertension
* Grade 1 or 2 relaxation abnormalities (Doppler E/A ratio \<1)
* Unchanged antihypertensive treatment for at least 12 weeks

Exclusion Criteria:

* Diabetes mellitus
* eGFR \< 60 mL/min/1,73 m²
* Mitral stenosis
* Atrial fibrillation
* Alanine transferase above 2N
Environmental Labelling in a Virtual Supermarket

A 2-arm randomised control trial (with and without labels) will be conducted to test the effects of an environmental label on food choices in a virtual supermarket. A sample of 130 participants will take part in two shopping tasks: 1/ selection of 3 products to prepare a home-made dish, and 2/ selection of a ready-to-eat dish. These two tasks will be repeated for two scenarios: 1/ participants will be asked to select the foods for usual meals, and 2/ participants will be asked to select the foods for environmentally-friendly meals. This experimental design will allow to compare food choices in the presence vs. the absence of an environmental label and to investigate whether the label is informative and likely to help individuals to choose more environmental-friendly food options when explicitly asked to do so.

See attached protocol documents

Eligibility Criteria:
Inclusion Criteria:

* Responsible for a substantial proportion of household grocery shopping
* Fluent in French

Exclusion Criteria:

* Dietary restrictions (vegetarian, vegan, allergies, intolerance, ...)
* Uncorrected eye problems
* Known symptoms of nausea and dizziness when wearing a virtual reality headset
Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis

The aim of our study is to assess miRNAs expression profiles in the circuling blood of patients with cystic fibrosis and highlight "signatures" that could reflect the pulmonary status of patients

The objective of this project is to study the circulating miRNA profiles in 40 patients with cystic fibrosis (5 samples which are acquired through a secondary use) and 40 healthy individuals to assess whether these biomolecules could be used as markers of the pulmonary disease in cystic fifbosis. Moreover by comparing miRNAs expression level between Cystic fibrosis (CF) patients with severe (n=20) or moderate (n=20) pulmonary impairment, we want to assess whether some of these miRNAs may be used as markers for the severity of CF pulmonary disease. The identification of sensitive and early markers, from a non-invasive sampling could enable more effective and early treatment of CF patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Cystic fibrosis (CF) (MIM#219700) who are compound heterozygous or homozygous for CF causing mutations Healthy controls non -smokers and free pulmonary disease

Exclusion Criteria:

* Participation or within the exclusion period of other clinicals trials Patients carrying mutations of clinical varying consequences or non CF-causing mutations
* smokers