cyrilzakka/clinical-trials huggingface dataset:
Follow-up of the Systemic Lupus Erythematosus Cohort as Part of the Multidisciplinary Consultation at Brest CHRU

Systemic lupus erythematosus is a complex systemicautoimmune disease that can affect most organs of the human body.

Although they are many recommendations on the diagnosis and managment of SLE, diagnosis and therapeutic managment is still challenging.

A pluridisciplinary consultation grouping rheumatologist, nephrologist, dermatologist, gynecologist, internist and immunologists has been set up in 2009 at the university hospital of Brest.

The investigators would like to identify in a longitudinal cohort the occurrence of the different clinico-biological and immunological patterns of systemic lupus erythematosus patients during our multidisciplinary consultation.

It is now crucial to organize a standardized data collection of these patients in order to evaluate our pratices, to be able to study the epidemiology of SLE in our city, and to promote this initiative at national and international level.


Eligibility Criteria:
Inclusion Criteria:

* Any patient over 18 years old of the multidisciplinary consultation

Exclusion Criteria:

* Opposition of patient
Symptoms and Outcome Measures for Upper- Limb Function in Myotonic Dystrophy Type 1

Myotonic Dystrophy type 1 (DM1) is a multisystem disease that causes muscle weakness and myotonia. As a result upper limb function might become impaired. In this study we will examine patients with DM1 and record their upper limb function. We will will use a battery of patient reported outcomes (PROs) and Outcome measures (OMs) in order to evalute which ones are suitable for use in clinical practise and research studies.


Eligibility Criteria:
Inclusion Criteria:

• Genetically confirmed Myotonic Dystrophy type 1

Exclusion Criteria:

* Unable to answer or understand questionnaires due to language barriers or cognitive status
* Unable to perform functional tests
Comparison of Pharmacodynamics and Pharmacokinetics of Biphasic Insulin Aspart 50 to Biphasic Insulin Aspart 70 in Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to compare the pharmacodynamics and pharmacokinetics of biphasic insulin aspart 50 three times a day to biphasic insulin aspart 70 three times a day in non-obese and obese with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Stable glycaemic control, having been on the existing treatment for at least 1 month
* BMI between 23-28 kg/m2 (non-obese) or between 30-35 kg/m2 (obese)
* HbA1c below 9.0%
* Willing to eat three main meals per day during the trial period and perform Self-Monitoring of Blood Glucose (SBGM) regularly

Exclusion Criteria:

* A history of drug abuse or alcohol dependence
* Blood donation within the last 3 months
* Currently being treated with systemic corticosteroids, Mono Amine Oxidase (MAO) inhibitors, beta-adrenergic blocking agents, anabolic steroids or any other drug affecting blood glucose
* Severe, uncontrolled hypertension
* Proliferative retinopathy or maculopathy requiring acute treatment
* Pregnancy, breast-feeding, intention of becoming pregnant or judged not to be using adequate contraceptive measures (for women of childbearing potential only contraceptive pills and intra uterine devices are considered as adequate contraceptive methods)
SNAP: Measurement of the Subjective Perception of the Symptom in Hereditary Spastic Paraparesis (HSP)

The Self-Notion and Perception (SNAP) questionnaire developed at IRCCS E.Medea by Eleonora Diella and Roberta Morganti, arises from the need to quantify the subjective perception of the patient suffering from HSP of the typical symptoms of pathology, such as spasticity, weakness, changes in balance, resistance in walking, pain and fatigue. The purpose of this study is to validate this instrument and test its reliability, looking for correlations with the measurement scales used in the literature for the evaluation of the patient with HSP. The most used for this population are the Spastic Paraplegia Rating Scale (SPRS) and the Six-Minute Walk Test (6MWT) which assess the severity of the disease and the level of endurance (8-9) respectively.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of genetically determined hereditary spastic paraparesis or subjects without defined genetics but who unequivocally show at the time of evaluation a dominant or recessive familiarity with exclusive involvement of the pyramidal system
* age\> 9 years
* IQ\> 80
* The patient must be able to walk for at least 10 meters. Indoors, even with help

Exclusion Criteria:

* Age less than 9 years
* IQ \<80,
* loss of gait
* psychopathological aspects that can affect the validity of the data collected
Effects of Epidural Lidocaine on the Pharmacokinetic and Pharmacodynamic Profiles of DepoDur® After Cesarean Delivery

To evaluate the levels of morphine in a patient's blood when morphine is given into the epidural space in the form of DepoDur® either alone or following a dose of lidocaine also given in the epidural space.

To evaluate the levels of morphine in a patient's blood when morphine is given into the epidural space in the form of DepoDur® either alone or following a dose of lidocaine also given in the epidural space. Specifically, we are looking at pregnant women undergoing cesarean delivery who will be receiving these medications. A secondary objective is to evaluate how well DepoDur® works for pain control, as well as its safety, when it is given either alone or following a dose of epidural lidocaine.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria will include healthy parturients between the ages of 18 and 40 who have American Society of Anesthesiologists physical status I or II, have an uncomplicated, singleton, term pregnancy, and are scheduled to undergo cesarean delivery.

Exclusion Criteria:

Exclusion criteria for the study will included refusal to participate, American Society of Anesthesiologists physical status III or higher or any severe uncontrolled medical condition, significant systemic medical or obstetric disease, morbid obesity, opioid, Nonsteroidal Antiinflammatory Drug (NSAID), or local anesthetic allergy or intolerance, chronic analgesic or antidepressant use, accidental dural puncture, ineffective spinal or epidural, and conversion to general anesthesia.
Renal Sympathetic Denervation From The Adventitia on Hypertension

Renal sympathetic denervation from the intima of renal arteries has become an important method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly located in the adventitia, and there is no report about renal sympathetic denervation from the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension, tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone, in some patients blood pressure control is still not desirable after resection of tumor aldosterone. This study intends to conduct renal sympathetic denervation ablation from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.

Renal sympathetic denervation from the intima of renal arteries has become an important method for the treatment of resistant hypertension, but renal sympathetic nerve are mainly located in the adventitia, and there is no report about renal sympathetic denervation from the renal adventitia. Primary aldosteronism is an important factor of secondary hypertension, tumor aldosterone in unilateral adrenal can increase the concentration of plasma aldosterone, in some patients blood pressure control is still not desirable after resection of tumor aldosterone.

This study intends to conduct renal sympathetic denervation ablation（RDN）from the adventitia to observe its efficacy and safety on blood pressure of patients with primary aldosterone.

Eligibility Criteria:
Inclusion Criteria:

1. . Renal artery diameter ≥4 mm and Length ≥20 mm;
2. . 18 years old ≤ age ≤ 70 years old;
3. . Specific diagnosis of adrenal adenoma and primary aldosteronism before the patients are enrolled in the study;
4. . Clinic systolic blood pressure≥160 mmHg and/or diastolic blood pressure≥100 mmHg (patients with type 2 diabetes: clinic systolic blood pressure≥150 mmHg and/or diastolic blood pressure≥95 mmHg) .
5. . 24 hours ambulatory blood pressure (SBP/DBP)≥140 and/or 90 mmHg;
6. . Estimated GFR (eGFR)≥45 ml/min / 1.73 m2.

Exclusion Criteria:

1. . Renal artery abnormalities include: either side renal arterial blood flow mechanics or anatomical obvious stenosis (≥50% ); Underwent renal artery balloon angioplasty or inserting a stent; Renal artery anatomy apparently is unusual to insert catheter;
2. . Cardiovascular instability includes: myocardial infarction in six months, unstable angina or cerebrovascular disease; Thrombus or unstable plaques in the arteries with extensive atherosclerosis; Hemodynamic apparently change in patients with heart valve disease;
3. . The patients with typeⅠdiabetes;
4. . Other serious organic disease;
5. . Participated in other clinical research.
Evaluating the Hunger Project in Ghana

The Hunger Project/Epicenter strategy is a community based development strategy that will positively affect health, education, empowerment, and consumption.

The investigators propose a randomized controlled design that will measure how The Hunger Projects' intervention affects the lives of Ghanaians. A pre-intervention baseline survey of approximately 4,000 households with over 20,000 individuals and two follow-up surveys of the same households will be conducted over the ten year experimental period.

Eligibility Criteria:
Inclusion Criteria:

* The subject population will be individuals and households from communities in the Eastern Region of Ghana.

Exclusion Criteria:

* Only exclusion criteria is that households outside of the Eastern region of Ghana will not be surveyed
US Guided Sacroiliac Joint Injection

Sacroiliac joint (SIJ) pain is one of the underappreciated causes of low back pain. Recent studies have reported excellent outcomes after Ultrasound (US) guided SIJ injection with local anesthetics and corticosteroids, but these studies are characterized by wide variability in selection criteria and patient characteristics; therefore, there is a need to determine whether any demographic or clinical variables can be used to predict US-guided SIJ injection outcomes.

this study is testing the different predictors related to the patient that could affect his improvement by \>50% after US guided SIJ injection with anaesthetic and steroids

Eligibility Criteria:
Inclusion Criteria:

* sacroiliac pain

Exclusion Criteria:

-
18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis

18F-GP1 binds with high affinity to the glycoprotein IIb/IIIa receptors on activated platelets. 18F-GP1 PET-CT has recently demonstrated favourable safety, pharmacokinetic, biodistribution and diagnostic performance for the in vivo identification of venous and arterial thrombemboli.

Aortic stenosis is the most common reason for valvular interventions in the developed world, with rates projected to increase as the population ages. Aortic valve replacement remains the only recognised treatment available. Bioprostheses are far more common than mechanical prostheses, particularly with increasing rates of transcatheter heart valve use.

Bioprothetic valves are less durable than mechanical valves and are subject to deterioration which may lead to clinical heart failure and the need for re-intervention. Long-term results with surgical bioprostheses are well reported, with valve deterioration rates of less than 15% at 10 years. These data, however, rely on re-operation rather than echocardiographic measures, suggesting that the true incidence of structural valve deterioration is underestimated.

Valve thrombosis is increasingly recognised as a potential contributor to leaflet degeneration and has been detected in participants undergoing both surgical aortic valve replacement and transcatheter aortic valve implantation. The role of valve thrombosis as an early trigger for calcification and subsequent valve degeneration has not been addressed. The true incidence of valve thrombosis and its impact on clinical outcomes is unknown due to the lack of a sufficiently sensitive non-invasive imaging modality to detect early subclinical thrombosis. Current observational data suggests rates of 12 to 40%, based on computed tomography findings. There is a clinical need for a more sensitive non-invasive method of detecting valve thrombosis.

Eligibility Criteria:
Inclusion Criteria:

* ability to give informed consent
* \>1 month post-surgical or transcatheter aortic valve replacement

Exclusion Criteria:

* Inability to give informed consent
* Pregnancy or breastfeeding
* Contraindications to iodinated contrast
* Contraindications to anticoagulation
* Use of anticoagulants during the post-operative period prior to screening
* Extreme claustrophobia
* Chronic kidney disease (with estimated glomerular filtration rate \<30 mL/min/1.73m2)
* Metastatic malignancy
* Inability to tolerate the supine position
The Role of CT-PET-MRI Image Fusion in Determining Radiation Treatment Volumes of Head-and-Neck Cancer Patients

Technical developments in radiation oncology are making it possible to deliver a prescribed radiation dose to radiation target volume with increasing accuracy.

Therefore it is becoming even more relevant to accurately define the radiation target volumes.

The current standard in defining radiation target volumes in patients with head-and-neck cancer is to combine physical examination data with a CT-scan in the treatment position.

The goal of this investigation is to analyse the rol of CT-PET-MRI image fusion in defining radiation target volumes.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for definitive radiotherapy with a Head and Neck Neoplasm (squamous cell carcinoma) in one of the following anatomical sites:

* oral cavity
* oropharynx
* hypopharynx
* larynx

Exclusion Criteria:

* age \< 18 years
* pregnancy
Retrospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses

The purpose of this study is to examine the long term effect of ultra-violet filtering contact lenses on macular pigment density (MPOD) and accommodative function.


Eligibility Criteria:
Inclusion Criteria:

* The subject is an adapted soft contact lens wearer of at least 5 years duration of either an UV filtering contact lens or a non-UV filtering contact lens
* The subject must report wearing their contact lenses, on average, for a minimum of 5 days each week.
* The subject must have best corrected visual acuity of 6/7.5 or better in each eye.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
* The subject must read and sign the statement of informed consent
* The subject must be between 18 and 43 years of age

Exclusion Criteria:

* On medication known to affect accommodation
* Active ocular surface pathology
* Had eye surgery
* Significant ocular tissue anomaly
* Any medical condition that may be prejudicial to the study
* Diabetes
Prevention of Milk-Borne Transmission of HIV-1C in Botswana

The purpose of this study is to find the most effective and safe treatment to prevent the passage of HIV from an infected mother to her baby.

1. To assess the effectiveness of the addition of a single dose of nevirapine (NVP) to Zidovudine (ZDV, also known as AZT) as used in the Botswana mother-to-child transmission (MTCT) National Program, in reducing transmission of HIV-1 from mother to child. To determine if maternal NVP (per HIVNET 012 protocol) is necessary in the setting of maternal ZDV from 34 weeks gestation through delivery AND single-dose prophylactic infant NVP at birth plus ZDV from birth to 4 weeks for the reduction of transmission of HIV-1 from mother to child.
2. To assess the effect of prophylactic AZT given to infants during breast feeding on HIV transmission.
3. To confirm the safety and tolerance of one dose of NVP given to mothers and infants
4. To evaluate the safety and tolerance of AZT given to infants for up to 6 months of age
5. To determine the association between assigned infant feeding strategy and maternal morbidity and mortality
6. To determine the rates of virologic response to NNRTI-containing HAART at 26 and 52 weeks after initiating treatment, among HIV+ women who previously received single dose NVP versus placebo during labour.

Eligibility Criteria:
Inclusion Criteria:

* Mothers must be no more than 34 weeks pregnant, intending to carry to term, intending to stay in area for at least 7 months, and consenting to HIV-1 testing and participation; HIV-1 infected by ELISA confirmed by Western blot; etc.
Hyperbaric Oxygen Treatment in Autism Spectrum Disorders

Hyperbaric oxygen therapy (HBOT) is part of a multidisciplinary therapeutic management of infant autism including psychotherapy, drug treatment and other therapeutics (speech therapy, occupational therapy restrictive diet ...).

It has been postulated that children with autism may benefit from HBOT due to the potential increase in cerebral perfusion occurring during treatment.

In fact, inhaling oxygen above atmospheric pressure could cause an increase in the arterial partial pressure of oxygen, leading to increased oxygen supply to the brain. HBO may also have anti-inflammatory properties due to the reduction in pro-inflammatory cytokines (tumor necrosis factor -α, interferon-γ and interleukins1 and 6). In addition, HBOT could improve mitochondrial dysfunction effects, as well as upregulate the production of antioxidant enzymes.Thus, hyperbaric oxygen therapy could be tried among the therapeutic arsenal of adjuvant treatments for autism.

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by difficulties in verbal and non-verbal communication and social interactions. People with ASD often exhibit difficult behaviors, including aggressiveness, temper tantrums, irritability, hyperactivity, inattention, impulsivity, self-harm ..

The increasing prevalence of autism spectrum disorders (approximately 1%) has increased the need for evidence-based treatment to lessen the impact of symptoms.

The ethiopathogenesis of ASD has so far been unclear. Current pathophysiological theories have demonstrated the presence of cerebral hypo-perfusion, neuro-inflammation, immune dysregulation and oxidative stress involved in the genesis of this disorder. Based on its anti-inflammatory effects and increased amount of dissolved oxygen, hyperbaric oxygen therapy has been tried as one of the therapeutic arsenals of adjuvant therapy for autism.

This is a randomized controlled study including nearly 80 patients with ASD who underwent clinical and neuropsychological evaluation before and after HBOT treatment as well as the dosage of the various biochemical and immunological markers. These markers will be assessed before and after the HBOT. Perfusion MRI would also be performed before and after HBO.

Eligibility Criteria:
Inclusion Criteria:

* All children aged 4 to 14 years who were followed in the child psychiatry unit during the study period and who were identified as having a diagnosis of ASD. This diagnosis was made by child psychiatrists experienced in autism using the DSM-5 criteria and the ADI and the Childhood Autism Rating Scale (CARS)

Criteria for non-inclusion :

* Children with hearing or visual impairments
* Children with unbalanced epilepsy
* Children with a contraindication to HBOT
* Dysfunction of the immune system

Exclusion criteria

-Child that havent completed entire protocol
The Difference of Weight Gain Tendencies and Obesity During Pregnancy

Background: Excess weight and obesity are a global pandemic, particularly among women of childbearing age. Pre-pregnancy obesity is linked to adverse maternal and neonatal outcomes, including preterm birth, macrosomia, stillbirth, and neonatal death. These risks vary by maternal age, race, and ethnicity, with rising rates among immigrant and minority women. This study investigates overweight and obesity rates in pregnant women, weight gain during pregnancy, and adherence to guidelines and possible neonatal outcomes, comparing Turkish and Syrian immigrant women.

Methods: This retrospective single-center study was conducted at Buca Seyfi Demirsoy Teaching and Research Hospital in Izmir, Turkey, over one year. Data collected included demographic information, pregnancy complications, delivery modes, maternal and neonatal anthropometric measurements, and neonatal morbidity and mortality. The study included Turkish and Syrian women with complete medical records. Statistical analyses were performed using SPSS software, with significance set at p \< 0.05.

Background: Excess weight and obesity are a global pandemic, particularly among women of childbearing age. Pre-pregnancy obesity is linked to adverse maternal and neonatal outcomes, including preterm birth, macrosomia, stillbirth, and neonatal death. These risks vary by maternal age, race, and ethnicity, with rising rates among immigrant and minority women. This study investigates overweight and obesity rates in pregnant women, weight gain during pregnancy, and adherence to guidelines and possible neonatal outcomes, comparing Turkish and Syrian immigrant women.

Methods: This retrospective single-center study was conducted at Buca Seyfi Demirsoy Teaching and Research Hospital in Izmir, Turkey, over one year. Data collected included demographic information, pregnancy complications, delivery modes, maternal and neonatal anthropometric measurements, and neonatal morbidity and mortality. The study included Turkish and Syrian women with complete medical records. Statistical analyses were performed using SPSS software, with significance set at p \< 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Being admitted to our hospital for delivery or having just given birth
* Being Turkish or Syrian
* Having all detailed information, including mothers' pregestational and immediate pre-delivery body weights, available in medical records

Exclusion Criteria:

* Significant deficiencies in medical records
* Belonging to an ethnic group other than Turkish or Syrian
Are Sutures Required for Vaginal Hysterectomy: A Randomized Controlled Trial

The hypotheses of this study is that the use of the instrument "Harmonic Scalpel" (ultrasonic shears) for vaginal hysterectomy instead of traditional sutures confers advantage over the use of traditional clamps and sutures. The proposed benefits and outcome measures are reduced blood loss, reduced operating time, reduced post-operative pain and earlier discharge from hospital. Other outcome measure will include complications and cost.

Patients booked for vaginal hysterectomy at Southern Health will be offered participation in this trial, and randomised to two separate groups: procedure using ultrasonic shears or traditional sutures. Each patient will receive detailed explanation in document form as well as from the Gynaecology registrar in pre-admission clinic prior to obtaining consent.

After the procedure of vaginal hysterectomy, a research associate will follow these patients up until discharge, collecting relevant data.

A statistician has been employed to perform power calculations, and to analyse data after collection, looking at outcomes mentioned above.

The Harmonic Scalpel has been extensively used to replace the use of traditional clamping and suturing in General Surgery, Laparoscopic surgery, and specifically Total Laparoscopic Vaginal Hysterectomies, but it has never been subjected to a randomised control trial to confirm the anecdotal benefits of the device.

Eligibility Criteria:
Inclusion Criteria:

* Any patient already on waitlist requiring vaginal hysterectomy

Exclusion Criteria:

* No patient consent