cyrilzakka/clinical-trials huggingface dataset:
Multicenter Italian Validation of EHP-30

The experience of the chronic illness negatively engraves on the quality of life of patients. Endometriosis is a disease that affects millions of women of childbearing age; it has repercussions on psychological health, as shown by numerous recent studies.

The aim of the present study is to validate the italian version of EPH 30, a self reported questionnaire, already used internationally, in order to determine the quality of life in women with endometriosis, assess their psychological health and the effectiveness of therapies.


Eligibility Criteria:
Inclusion Criteria:

* Previous surgical and histological diagnosis of endometriosis

Exclusion Criteria:

* Severe underlying comorbidities (gynecological, cardiovascular, respiratory, renal, hematological, endocrine, hepatic, gastrointestinal, neurological)
* Psychiatric diseases
* Refusal or inability to sign the informed consent
Study of Body Composition in Patients Treated by Adjuvant Hormonal Therapy for Breast Cancer (MetaCa2)

This cross-sectional study of pathophysiology will bring additional informations on body composition of patients treated by adjuvant hormonal therapy for breast cancer. This is a complementary study of Metaca study (AU882).


Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women
* patients requiring hormonal treatment
* WHO performance status 0-2
* patients initially included in MetaCa (AU882) protocol
* Affiliation to a social security scheme (or be the beneficiary of such a plan)
* patients who signed the informed consent form

Exclusion Criteria:

* patients witg relapse, with metastases or other cancer
* concurrent treatment with a drug test, or participation in a clinical trial within \< 30 days
* patients carrying an electronic medical device (eg pacemaker)
* patients who refused to sign the consent form
The Effects of Resveratrol Supplementation on Inflammation and Cognitive Performance in Healthy Adults

Previous research has suggested that high levels of systemic inflammation can contribute to cognitive deficits and additional health problems; consumption of polyphenols have been shown to have an anti-inflammatory effect. Resveratrol, a polyphenol found primarily in red grape skins, has previously been shown to improve brain blood flow and possibly brain function and may potentially reduce systemic inflammation, however there is limited research into this.

This study will investigate the effects of 4 weeks daily consumption of resveratrol on inflammation and cognitive function in healthy adults.

Each participant will be required to attend the laboratory on three occasions. The first of these will be an initial screening/training visit, this will take place in the afternoon and last 2 1/2 hours in total. During the initial visit participants will be asked to provide written informed consent. They will provide lifestyle and demographic data and screened regards to physical health (height, weight, blood pressure, waist to hip ratio). They will then complete a food frequency questionnaire and be trained on the computerised cognitive and mood tasks. Participants will also be trained on completing the cognitive assessment battery on their mobile phone, they will complete a further 5 assessments on their phone, once the day before their first visit and every 7 days during the supplementation period.

Study days 1 and 2 (4 weeks apart) :

Participants will arrive at the laboratory at an agreed time in the morning (7am, 8.30am or 10am) having fasted for 12 hours, avoided caffeinated products for 18 hours, alcohol and over the counter medication for 24 hours and oral antihistamines for 48 hours prior to the session commencing.

Participants will provide a blood sample, they will then complete a short computerised cognitive assessment (\~20 minutes in length), followed by measurements of blood pressure and heart rate. Following this the participants will consume their treatment for the day, followed by a 40 minute absorption period and then will complete the second cognitive assessment. Participants will then provide a second blood sample. At the end of the first study session participants will be provided with their treatment and treatment diary, they will be instructed to take one tablet twice a day (30 minutes after breakfast and dinner). Both study visits will be identical and will take place 29 days (+/- 2 days) apart.

Eligibility Criteria:
Inclusion Criteria:

* Participants must self-assess themselves as being in good health.
* Aged 18 to 55 at the time of giving consent

Exclusion Criteria:

* Have a Body Mass Index (BMI) outside the range of 18.5-42kg/m2
The (Cost-)Effectiveness of Physician Assistants Working at the Primary Out of Hours Emergency Service

The aim of this study is to explore the effect of substituting General Practitioners (GPs) by Physician Assistants (PAs) in out-of-hours primary care. Effects are measured in terms of the implication for the care model, quality of care delivered by PAs in comparison to GPs; the complaints treated by PAs in comparison to GPs; safety, efficiency and patient satisfaction. Lastly, this study will provide insight in the changes in costs of healthcare.

Out-of-hours care in the Netherlands is under pressure. Workload for general practitioners (GPs) during out-of-hours care is high and there are concerns about maintaining the quality of care. Since 80% of the complaints shown in out-of-hours care are low complex and not urgent, not all patients necessarily have to be seen by a physician. Shifting care from GPs to physician assistants (PAs) is considered to be a possible method to reduce workload while maintaining high quality and safety of care.

Previous research, on PAs in primary care during office hours, has shown PAs were found to be acceptable, effective and efficient in complementing the work of GPs.

We hypothesize that in a team of PAs and GPs working out-of-hours primary care, the PAs will deliver care to less urgent and complex complaints, deliver quality of care comparable to GPs and their implementation will lead to a reduction in cost of healthcare.

We compare care provided by a team of PAs and GPs with a team of only GPs. Within the team of PAs and GPs we make a comparison between the two healthcare professionals.

Eligibility Criteria:
Inclusion Criteria:

* Patients (with urgency U2, U3, U4, or U5) requesting an appointment at the primary out of hours emergency service during the weekend between 9.00 and 17.00 hours.

Exclusion criteria:

* None
Buprenorphine Detoxification With Two Types of Treatment. BBD III - 12

The purpose of this study is to evaluate buprenorphine and behavioral treatment with and without contingent payment on compliance with naltrexone.


Eligibility Criteria:
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14-day Quadruple Therapy Versus Triple Therapy in HP Eradication

In this prospective randomized-controlled study, treatment-naive H. pylori-infected patients are randomized to receive either standard triple therapy or sequential therapy. The aim is to compare the efficacy of concomitant quadruple therapy with standard triple therapy as a first line treatment for H. pylori infection in Tunisian patients.

This study includes male and female patients aged between 18 and 65, with documented Hp infection and who have had no previous eradication treatment.The diagnosis of Hp infection was made through an anatomopathological study. Gastric biopsies were taken according to the Sydney protocol: two fundics in one pot, two antrals and one at the angle of the lesser curve in a second pot. The biopsies were studied by an experienced anatomopathologist.

The included patients were randomly divided into two treatment groups according to a 1: 1 ratio: the first group received concomitant quadruple therapy (QC) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with the amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days. The second group received triple therapy (TT) combining a double dose PPI (esomeprazole: 40 mg x 2 per day) with amoxicillin (1 g x 2 per day) and clarithromycin (500 mg x 2 per day) for 14 days.

H. pylori eradication was assessed by the 13C-urea breath test 8 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 18 and 65, with documented Hp infection.

Exclusion Criteria: are excluded patients:

* With Cirrhosis.
* With Renal failure (serum creatinine\> 120 µmol / L).
* Having complicated peptic ulcer (stenosis or hemorrhage or perforation) in an acute phase.
* Having severe psychiatric disorders.
* Having had gastric surgery in their history.
* Having already received an HP eradication treatment.
* Having received an antibiotic within the last two weeks.
* Who are allergic to one of the antibiotics used in the anti-Hp cure.
* Who are drug addicted.
Antibody Persistence in Healthy Children After Primary and Booster DTaP-IPV-Hep B-PRP-T Vaccine or Control Vaccine

The purpose of this study is to evaluate the long term immunogenicity produced in children by the investigational hexavalent vaccine (DTaP-IPV-Hep B-PRP-T) given in Study A3L15 (NCT 00362336).

Primary Objective: To describe the antibody long term persistence at 3.5 and 4.5 years of age following a 3 dose primary series vaccination of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + Oral poliovirus vaccine (OPV) + Engerix™ B vaccination at 6, 10 and 14 weeks of age and a booster vaccination of DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + OPV at 15-18 months

All participants must have received the primary series of vaccinations and a booster vaccination in Study A3L15 (NCT 00362336).

Participants will receive no vaccination in this study but will undergo immunologic assessments at 3.5 and 4.5 years of age.

Eligibility Criteria:
Inclusion Criteria :

* Aged 3 years and a half on the day of inclusion (42 months ± 60 days)
* Informed consent form signed by a parent or other legally acceptable representative and by an independent witness if the parent or other legal guardian is illiterate.
* Subject and parent/ legally acceptable representative able to attend the scheduled visits and to comply with all trial procedures.
* Receipt of primary vaccination with 3 doses of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™ + Oral poliovirus vaccine (OPV) + Engerix™ B and a booster dose of either DTaP-IPV-Hep B-PRP-T or CombAct-Hib™+ OPV.

Exclusion Criteria :

* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the inclusion in the trial.
* Incomplete primary and booster immunization at trial A3L15.
* Previous confirmed clinical, serological, or microbiological diagnosis of diphtheria, tetanus, whooping cough, poliomyelitis, Haemophilus influenza b or hepatitis B after completion of A3L15 Study.
* Subjects known to have received diphtheria, tetanus, pertussis, Haemophilus influenza b and hepatitis B vaccination after completion of A3L15 Study.
* Any vaccination within 30 days preceding inclusion, except for measles or poliovirus (monovalent) containing vaccines and pandemic influenza vaccines including pandemic H1N1-2009 strain, which may be received at least two weeks before the subject's blood sample collection
* Blood or blood-derived products received at the latest 3 months before inclusion, receipts of immunosuppressant drugs within the previous 3 months.
* Known or suspected congenital or acquired immunodeficiency since completion of A3L15 Study.
* Serious chronic illness occurring after receipt of the primary and booster series (e.g. leukemia, lymphoma \[Tor B cells\], Crohn's disease).
* Known or suspected subject seroconversion for human immunodeficiency virus (HIV) or hepatitis C seropositivity since completion of A3L15 Study.
* Febrile (temperature ≥ 38.0°C) or acute, moderate or severe systemic illness on the day of inclusion.
Evaluation of Breastfeeding Support After Short Time Hospitalization

The purpose of this study is to evaluate if the developed theory and evidence based programme has a positive effect on mother's breastfeeding self efficacy, establishing an effective breastfeeding and breastfeeding duration after short time hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women (gestational week 35-36)

Exclusion Criteria:

* women with known physical, psychological and/or social illness/problem that result in hospitalization more than 50 hours after delivery
* women with known pregnancy related illness that result in hospitalization more than 50 hours after delivery
* Women not understanding or speaking Danish
* women expecting multiple babies
* women having decided not to breastfeed
* women expecting to deliver at another hospital than the one she has been visiting during pregnancy
A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis Carinii Pneumonia

To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in European patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).

Patients receive intravenous infusions of trimetrexate glucuronate and leucovorin for 21 days. Leucovorin is continued for 3 additional days after discontinuation of trimetrexate glucuronate. Patients are followed for 1 month.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry.
* Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, OR a documented history of such intolerance during a prior episode.
* Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Patients with the following prior conditions are excluded:

History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.
Low-fidelity Simulation to Teach Anesthetists' Non-technical Skills in Rwanda

The goal of this study is to examine whether low-fidelity instructor-driven simulation can provide effective teaching of anesthetists' non-technical skills in a developing world context. Human factors, such as communication, planning, and team working are considered nontechnical skills which contribute greatly to patient safety in "complex hazardous systems" such as aviation, nuclear power industry, and operating rooms. Simulation began in the aviation industry to train pilots in human factors. In the past two decades simulation has been valued in medical education as it allows the learner to rehearse skills in an environment that is similar to the workplace but without the threat of harm to patients. High Fidelity simulators involve computer driven interactive mannequins that recreate an authentic environment. This has been used successfully to teach anesthetists' non-technical skills (ANTS) such as: decision making, team working, task management, and situation awareness. Anesthetists' non-technical skills are particularly important in developing countries where the shortage of supplies, equipment, and qualified personnel can lead to a perilous working environment making team work and communication vital for patient safety. The costs of high fidelity simulation are prohibitive for many developing countries. This study seeks to examine whether low fidelity instructor driven simulation can provide an effective intervention to teach anesthetists' non-technical skills in Rwanda. If found to be effective, this method of training could be applied to other developing countries to improve non-technical skills for anesthesia providers with the goal of making surgery safer.


Eligibility Criteria:
Inclusion Criteria:

* anesthesia providers (resident or technician) that provides anesthesia for caesarean section

Exclusion Criteria:

* anesthesia providers that do not provide anesthesia for caesarean section
Trans-obturator Mid-urethral Sling and the Single-incision Sling in Women With Stress Urinary Incontinence

Mid-urethral slings (MUS) now represent a gold standard in the treatment of female stress urinary incontinence (SUI). Second generation trans-obturator slings (TOT) have proven to be as effective as retropubic tension-free vaginal tape (TVT) with fewer major complications. A third generation of the MUS inserted through a single vaginal incision (SIS) has become a means to overcome significant post-operative groin pain. Novel types of SIS with a more robust and adjustable anchoring mechanism can assure adequate long-lasting attachment to the obturator membrane (OM). Objective of this study was to compare an inside-out TOT with an innovative fixation SIS in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.

Objective of this study was to compare an inside-out TOT (Gynecare TVT Obturator System, Ethicon) with an innovative fixation SIS (Ophira, Promedon) in randomized controlled trial on patients undergoing their primary surgery for urodynamic SUI.

A prospective randomized controlled trial (RCT) is performed in one tertiary referral urogynecology center from January 2015 thru December 2015. Study included women with pure or predominant urodynamic SUI confirmed during cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position. Study was carried out on a Caucasian Czech (central European) population. A study power analysis was calculated with an expected objective cure rate of minimum 80 % for both patient groups, false non-match rate (alpha) of 0.05, and false match rate (beta) of 0.10. A minimum sample size of 80 patients was required for each group.

Eligibility Criteria:
Inclusion Criteria:

Women with pure or predominant urodynamic stress urinary incontinence confirmed during filling cystometry by positive standardized cough stress test (CST) with urinary bladder filling of 250 ml in lithotomy position.

Exclusion Criteria:

* patients with predominant urge incontinence
* patients with intrinsic sphincter deficiency (MUCP\<20 cmH2O)
* pelvic organ prolapse (POP-Q\>2)
* previous urinary incontinence surgery
* previous pelvic organ prolapse surgery
* presence of other pelvic organ pathology.
Prospective Study for Prognostic Biomarkers of Nasopharyngeal Carcinoma

The purpose of this clinical research project is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma.

Objectives:

Primary: Evaluation of failure-free survival after three years of patients of nasopharyngeal carcinoma.

Secondary: Evaluation of overall survival after three years of patients of nasopharyngeal carcinoma.

Outline: This is a multicenter observational study. Tumor tissue specimens are obtained from the Sun Yat-sen University Cancer Center and Affiliated Hospital of Guilin Medical University. The samples are analyzed for biomarkers. The biomarkers are correlated with clinical outcomes (failure-free survival, overall survival, tumor response to treatment, distant metastasis, recurrence and death).

The aim of the analysis is to explore potential biomarkers and validate the predictive and prognostic value of molecular signature in nasopharyngeal carcinoma. This will lead to the definition of risk groups and stratification of patients and will help to precision medicine of nasopharyngeal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed nasopharyngeal carcinoma
* No evidence of distant metastasis (M0)
* Written informed consent

Exclusion Criteria:

* Treatment with palliative intent
Outreach-ER: A Dementia Care Intervention Program

This is a feasibility/pilot, prospective cohort study to determine how to implement and refine Outreach-ER intervention for a larger clinical study. A key feature of Outreach-ER is to reach out to people living with dementia (PLWD) and their families following an emergency room visit or hospitalization. The outcome of this study will help in the overall goal of studying the impact of Outreach-ER in a larger clinical study and focus on outcomes relevant to PLWD and their care partners.


Eligibility Criteria:
Inclusion Criteria:

* PLWD with a recent Emergency department visit or admission at Regions Hospital
* Diagnosis of dementia based on international classification of diseases (ICD) Codes in the medical record
* Provides informed consent prior to participation
* Must be able to read and speak English
* PLWD Living at Home
* Age \>=18 years for PLWD and their care partner

Exclusion Criteria:

* PLWD living in a nursing home/Long term care - Assisted living facility
* Current involvement in another clinical research study/trial for care partners
* PLWD medical record number (MRN) on the HealthPartners (HP) exclusion list
Steroid-Sparing Effect With Pimecrolimus in Pediatric Patients With Atopic Dermatitis

This study will investigate the steroid sparing effect of pimecrolimus cream 1% in pediatric atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged 2 to \< 18 years with severe AD (score 8 or 9 according to Rajka and Langeland)
* responded to 21 days of treatment with prednicarbate cream 0.25% during screening phase

Exclusion Criteria:

* Patients who had received phototherapy, systemic or topical therapy or systemic corticosteroids shortly prior to study
Advanced Magnetic Resonance Imaging in Temporal Lobe Epilepsy

We aim to o evaluate the role of conventional and advanced MRI sequences in diagnosis of idiopathic temporal lobe epilepsy including identification and lateralization of epileptogenic focus.

Patients with history of partial seizures with or without secondary generalization attending at outpatient clinic or admitted at Neurology department of Assuit University Hospital will be included in the study MRI study will be done for each patient. MR imaging will be performed on a 1.5-T MR imaging unit (Siemens, Sembra medical system,German).

Prospectively completed data forms will be analyzed and compared. Statistical tests appropriate to the nature of the data will be used.

All patients will not be subjected to risk of any kind during this study. All patients' data will be confidentially kept. Approval of the ethical committee of Faculty of Medicine, Assiut University.

An informed consent will be taken from all patients included in this study. The research will be conducted only by scientifically qualified and trained personnel.

The procedures included in this study have been already used in hospital and centers in and outside Egypt

Eligibility Criteria:
Inclusion Criteria:

* patients with history of partial seizures with or without secondary generalization attending at outpatient clinic or admitted at Neurology department of Assuit University Hospital will be included in the study based on the following criteria:

  * Clinical features consistent with seizures of temporal lobe origin.
  * Focal ictal temporal lobe patterns recorded with EEG.
  * No lesion detected by conventional MR imaging other than mesial temporal sclerosis.

Exclusion Criteria:

* Any general contraindication of MRI in some cases as presence of para magnetic substance as pacemakers or in patients with claustrophobia.
* Subjects with age less than 12 year old.
* Patients with any structural lesion other than mesial temporal sclerosis identified on MR brain imaging.