cyrilzakka/clinical-trials huggingface dataset:
Phase II Study of ASP3550 in Patients With Prostate Cancer

To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer

Two doses of ASP3550 were administered to patients with prostate cancer. The primary efficacy variable was the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
* Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
* Has a serum testosterone level above 1.5 ng/mL at screening
* Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2

Exclusion Criteria:

* Previous or present endocrine treatment for prostate cancer. However, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months preceding Screening Visit may be included
* Is being treated with a 5α-reductase inhibitor
* Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
* Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema
Blood Biomarkers to Predict the Prognosis of a Stroke Patient Undergoing Mechanical Thrombectomy

The goal of this observational study is to evaluate the accuracy of a panel of blood biomarkers and clinical variables in predicting the prognosis of stroke patients treated by mechanical thrombectomy, specifically to predict futile recanalization and mortality.

Stroke is the leading cause of long-term disability and the second most common cause of death worldwide, accounting for around 6.7 million deaths each year. The burden of stroke due to illness, disability and early death is set to double within the next 15 years due to an ageing population. The socio-economical cost of the stroke is very high, being around 45 million euros per year in Europe. Although mechanical thrombectomy is the most effective treatment for stroke patients with large vessel occlusions still a large percentage of patients, around 50%, do not recover despite a successful recanalization (the so called "futile recanalization"). Therefore, to anticipate the prognosis of patients treated with mechanical thrombectomy would be clinically relevant and very informative.

This observational study evaluates the precision of a rapid test of blood biomarkers in the prognosis of stroke patients treated by mechanical thrombectomy. For that, the investigators will recruit a cohort of 400 consecutive patients treated by thrombectomy. Using a multiplex POC for the biomarker measurement and an APP in combination with clinical data, the potential of biomarkers to predict the prognosis of a patient will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old.
* Patient in whom a mechanical thrombectomy is performed.

Exclusion Criteria:

* Impossibility of getting a blood sample.
* Impossibility of performing the test (Invalid results)
* Refusal to provide the informed consent by the patient/relative.
Contrasting the Brain Effects of Risperidone and Invega With Functional Magnetic Resonance Imaging (fMRI) and Positron Emission Tomography (PET) Scanning

The purpose of this study is to better understand brain function and psychiatric and neurological illness when taking Invega or Risperdal. The objective is to compare the brain effects of Invega to Risperdal in patients with Schizophrenia. This comparison will be evaluated with PET imaging, fMRI, and neurological ratings and assessments.


Eligibility Criteria:
Inclusion Criteria:

* are currently taking Risperdal and have been on the medication for at least three weeks
* are diagnosed with schizophrenia
* are able to provide written informed consent
* can safely have an MRI

Exclusion Criteria:

* are treatment resistant or intolerant to Risperdal
* have participated in another drug study in the past 28 days
* are pregnant or trying to become pregnant or are breastfeeding
* are colorblind
* have a history of alcohol, cannabis, or cocaine abuse within two weeks prior to the study
* have a current or past history of a major medical illness or have abnormal lab values which the study doctor feels is significant
* certain medications are also exclusionary including aripiprazole.
Effectiveness of SDF in Arresting Dental Caries in Preschool Children

Background: Tooth decay in children (Early childhood caries, or ECC) is a common childhood disease. Poor dentition significantly affects the nutrition, growth, development and general health of children. Conventional dental care for ECC is neither affordable nor accessible, particularly for the disadvantaged communities. Silver diamine fluoride (SDF) is a safe, cost-effective caries-arresting agent that appears to conform to the World Health Organization's Millennium Goals. SDF is commercially available at 38% and 12%, and topically used yearly or half-yearly to arrest ECC. The SDF regimens used for ECC treatment lack an evidence base. Therefore it is necessary to find the most suitable SDF concentration and application interval to arrest ECC. The purpose of this randomised controlled trial is to compare the efficacy of two commercially available SDF solutions at pre-prepared concentrations of 38% and 12% when applied at yearly or half-yearly intervals over 36 months in arresting caries in primary teeth.

Methods / Design: This double-blinded study has recruited 888 kindergarten children aged 3-4 years with caries. The sample size is sufficient for the appropriate statistical analyses. The children were classified into high and low caries rates and equally allocated into four groups for the caries treatment:

Group A - semi-annual application of 12% SDF; Group B - annual application of 12% SDF; Group C - semi-annual application of 38% SDF; Group D - annual application of 38% SDF. The children will be followed for 36 months in their kindergartens until they enter primary school. Clinical examinations at 6-month intervals will be conducted to assess whether the caries are arrested. Information on confounding factors, such as oral hygiene habits and the use of other fluoride agents, will be collected through a parental questionnaire at the baseline and follow-ups.

Discussion: This study will help determine the most suitable SDF concentration and application interval to arrest caries in children. Because SDF use for caries arrest is painless, simple, and low-cost, it can be widely recommended and promoted for caries control in young children or those with difficulty accessing and affording conventional dental care. The applicability of the findings and their impact on public health would be immense.


Eligibility Criteria:
Inclusion Criteria:

The children included in the study should

1. aged 3-4 years who have tooth decay and are attending the first year of kindergarten,
2. be generally healthy,
3. have parental consent, and
4. have at least 1 tooth with untreated caries that extends into the dentine.

Exclusion Criteria:

* Children who are uncooperative and difficult to manage, have major systemic diseases, or are on long-term medication will be excluded.
Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial

The objective of the proposed study is to investigate the diagnostic accuracy of ED POCUS in pediatric traumatic thoracic injuries including traumatic pneumothorax, hemothorax, lung contusion, rib fractures, and pulmonary edema (from submersion injury). This will be a prospective, multicenter, observational study of children 0-21 years of age presenting to the participating pediatric emergency departments for suspected traumatic thoracic injury. Results of POCUS will be compared to that of chest X-ray, final clinical diagnosis, computed tomography (CT) or magnetic resonance imaging (MRI). Study hypotheses are that POCUS is highly accurate (90-95%) when compared to chest X-ray, and moderately accurate (\~80%) when compared to CT or MRI in diagnosing these conditions.


Eligibility Criteria:
Inclusion Criteria:

* Eligible subjects will be children 0 to 21 years of age presenting to the participating PEDs meeting trauma activation criteria and with suspected thoracic injury.

Exclusion Criteria:

* Congenital or acquired cardiopulmonary or osteogenic conditions rendering POCUS ineffective, foreign body/ barrier to lung ultrasound of which removal is contraindicated, subjects under law-enforcement custody, and subjects deemed unsuitable by treating clinicians.
Thiamin Deficiency in Obese Thai Children

This study is aimed to assess the prevalence of thiamin deficiency in obese Thai children.

This study is a cross-sectional study. The objectives of the study are to determine the prevalence of thiamin deficiency in obese Thai children and to assess the associations of dietary factors and thiamin deficiency.

Eligibility Criteria:
Inclusion Criteria:

* obese : weight for height \> median + 3 standard deviations
* simple obesity

Exclusion Criteria:

* pathological obesity
* chronic diseases e.g. cerebral palsy, metabolic disease, etc.
* diseases of red blood cells
* on medication e.g. steroid, multivitamins, thiamine-containing vitamins, diuretic drugs
* hemodialysis or peritoneal dialysis
* bariatric surgery
Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass

Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and secondary outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.

No consensus is proposed by the Medical and Surgical societies to define and / or prioritize surgical procedures in obesity surgery. Indications are based on patient's age, sex, dietary habits, the importance of overweight and associated comorbidities and even if rarely admitted, based on knowledge of surgical teams and the cost of interventions. Given the decrease of gastric banding procedures, Roux-en-Y gastro-jejunal bypass is often considered the reference procedure.

The gastric bypass, developed in the 60s, is performed laparoscopically since the early 90s. It allows for a 60% to 70% excess weight loss with control over 75% of comorbidities. It is recommended to follow these patients long-term because late complications can occur. These patients require ongoing information and regular monitoring. They must also have a hyper-protein diet and a vitamin substitute long-term (multivitamins, vitamin B12, calcium ...).

The Sleeve gastrectomy (SG) arises as an alternative to RYGB. It was classically proposed to patients with a BMI greater than 60 and significant comorbidities since the procedure let to a significant weight reduction in patients for whom any other procedure was too difficult to perform. The quality of the weight loss achieved in these patients has led many teams to analyze the results of this intervention without conducting an additional procedure. It appears from the literature that even performed alone, SG presents many benefits.

To clarify the role of sleeve gastrectomy in the bariatric procedures range, the investigators propose to conduct a prospective randomized study to compare laparoscopic sleeve gastrectomy to Roux-en-Y gastric bypass.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 and \< 60 kg/m2
* No contraindication to any of the procedures
* No contraindication to general anesthesia
* No known addiction
* Patient able to provide informed consent

Exclusion Criteria:

* Contraindication to general anesthesia
* Known psychiatric pathology
* Pregnancy
* Previous major digestive surgery
* Immunosuppressive treatment including corticoids
* Coagulopathy (INR\>1.5) or platelets \< 50 000/µl
* Anemia (Hb\<10g/dl)
* Severe comorbidity
* Malabsorptive disease or gastro-intestinal disease
* Myocardial infarction in previous year, angina, cardiac failure
Safety, Tolerability and Pharmacokinetics in AD Subjects and Healthy Subjects of Cutaneous Application of LEO 39652 Cream

The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic dermatitis and to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects or subjects with AD as defined by the Hanifen and Rajka criteria and with at least mild disease activity (IGA \>2) for the whole body
* AD lesions amenable to cutaneous treatment located on the trunk and/or limbs (only for AD subjects)
* Male subjects aged between 18 and 65 years with a body mass index (BMI) between 19.0 and 32.0 kg/m2 inclusive

Exclusion Criteria:

* Subjects who currently suffer from, or show signs of eczema or other skin lesions (only for healthy subjects)
* Subjects who are still participating in a clinical trial (e.g. attending follow-up visits) or who have participated in a clinical study involving administration of an investigational product or a marketed drug product within the past 3 months prior to the first dosing occasion.
* Subjects with known immunocompromised state due to treatment with immunosuppressive drugs or due to history of a disease leading to immunocompromised status.
* History of or current cardiac arrhythmic disorder
* Subjects with a current active malignancy or a history of malignancy in remission for less than 5 years except excised skin (not melanoma) and cervical cancer.
* Subjects who have any clinically significant allergic disease (excluding non- active hayfever) as determined by the Investigator
The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection

To determine the safety of thymosin alpha 1 given twice weekly in a regimen of daily oral zidovudine (AZT) and biweekly polyethylene glycolated interleukin-2 (PEG IL-2). To determine the effect of thymosin alpha 1 and PEG IL-2 in combination with AZT on immunologic and pharmacokinetic markers.

AIDS is characterized by diminished T helper cell number and function. Thymosin alpha 1 appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo; thus, the drug may further enhance the CD4 T cell levels in patients receiving AZT and PEG IL-2.

AIDS is characterized by diminished T helper cell number and function. Thymosin alpha 1 appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo; thus, the drug may further enhance the CD4 T cell levels in patients receiving AZT and PEG IL-2.

Patients are stabilized on oral AZT daily for 8 weeks and then begin receiving bolus infusions of PEG IL-2 every other week for at least four doses. Thymosin alpha 1 (given SC) is then added to this regimen twice weekly for 4 weeks. If no significant toxicity occurs, thymosin alpha 1 is increased to and administered along with scheduled doses of PEG IL-2 for an additional 8 weeks.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylactic pentamidine for Pneumocystis carinii.

Patients must have:

* HIV seropositivity.
* CD4 count \> 50 and \< 200 cells/mm3.
* No active opportunistic infections.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or Kaposi's sarcoma.
* Significant cardiac disease or CNS lesions or other neurologic abnormalities.
* Score of \> 0.5 on ACTG AIDS Dementia Complex staging.
* Major organ allograft.
* Intolerance to AZT at 500 mg/day.

Concurrent Medication:

Excluded:

* Antihypertensive medication other than diuretics.
* Chemotherapy, hormonal therapy, or other immunotherapy.
* Other investigational drugs, agents, or devices.
* Beta-blockers.
* Non-topical steroids.

Concurrent Treatment:

Excluded:

* Radiation therapy.

Prior Medication:

Excluded:

* Known anti-HIV medication (other than AZT) or known immunomodulators (e.g., systemic steroids, interferons, interleukins) or other chemotherapy within 30 days prior to study entry.

Prior Treatment:

Excluded:

* Transfusion within 4 weeks prior to study entry.
* Radiation within 30 days prior to study entry.

Active substance abuse.
Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea

The purpose of this study is to investigate the utility of high-flow nasal oxygen during sleep endoscopy in obstructive sleep apnea patients.


Eligibility Criteria:
Inclusion Criteria:

* adult patients aged over 19 years who are scheduled for sleep endoscopy

Exclusion Criteria:

* 1) basal skull fracture, 2) facial anomaly, 3) consciousness disorder, 4) Risk of aspiration, 5) necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.
Accuracy of Intra Ocular Lens CARLEVALE Calculation

The purpose of this study is to assess the accuracy of intra ocular lens power calculation using the new Carlevale sutureless scleral fixation posterior chamber intra ocular lens.

Retrospective comparison of refractive spherical equivalent predicted before surgery and measured after surgery in patient who underwent implantation of an sutureless scleral fixation posterior chamber intra ocular lens between October 2019 and Avril 2022 in the ophthalmology department of Poitiers Hospital and La Rochelle Hospital.

Eligibility Criteria:
Inclusion Criteria:

* All patients who underwent implantation of Carlevale between Octobre 2019 and Avril 2022 in the ophtalmologie department of Poitiers hospital and La Rochelle hospital

Exclusion Criteria:

* Post surgery best corrected visual acuity worse than 20/40
* Keratoconus
* Macular oedema
Contribution of Per Dialytic Physical Activity in Chronic Dialysis Patients

Dialysis patients have reduced walking capacity and an important risk of high blood pressure. These complications are associated with a decline in quality of life and increased mortality. The hypothesis of the study is to show that physical activity during the dialysis session in dialyzed patients has a benefit on quality of life, as well as on muscle, cardiovascular and dialysis parameters.

Dialysis patients have reduced aerobic capacity, walking ability, and an increased risk of hypertension. These complications are associated with a decline in quality of life and increased mortality.

Since asthenia is too intense after the dialysis session, patients are encouraged to perform physical activity during dialysis sessions. Some studies have shown that physical activity during dialysis can have benefits on quality of life and improve muscle parameters, but without this being clinically significant. Other studies show no benefit. The objective of the study is to explore the benefits of physical activity on quality of life, muscle parameters, and biological and dialysis parameters in a cohort of compliant hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and over, undergoing chronic hemodialysis at CHI André Grégoire for more than 3 months.
* Consent to participate in physical activity during dialysis sessions.
* Written informed consent.
* Affiliation with a social security system

Exclusion Criteria:

* Lower limb amputation without a prosthesis.
* Non-healed foot wounds.
* Hemoglobin \< 8 g/dl.
* Patient refusal to participate.
* Severe respiratory (oxygen dependence) or cardiac disease (NYHA class 3 or 4, LVEF \< 30%).
* Advanced dementia or psychiatric illness impeding cooperation, or refusal to consent.
* Non-French speaking patients unable to understand the study.
* Patients under guardianship.
* Advanced osteoarthritis, recent hip or knee prosthesis (\< 3 months).
* Hypotension (BP \< 90/40 mmHg) or hypertension (BP \> 180/110 mmHg).
* Fever (temperature \>= 38°C).
* Hypoglycemia (fingerstick glucose \< 0.8 g/l) in diabetic patients.
* Dyspnea or desaturation in ambient air \< 95%.
* COVID-19 symptoms within the last 21 days, positive PCR test, unable to pedal.
* Chest pain or unstable angina.
* Muscle or joint contraindications to the pedal exerciser as assessed by a physiotherapist
Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal

Weaning from invasive mechanical ventilation is one of the major clinical problem especially ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.

The aim of this pilot feasibility and safety trial is to assess the possibility of shorten the duration of mechanical ventilation using a device able to remove CO2 and theoretically able to allow therefore the praecox extubation

Weaning from invasive mechanical ventilation is one of the major clinical problem especially ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania. Up to 60% of the ventilatory time is devoted in these patients to the process of weaning.

These patients very often fail several weaning attempt, when a T-piece trial method is used. In this case they are also very likely to require tracheotomy.

In this study we will enroll those still hypercapnic patients fitting the criteria of readiness to be wean (i.e. clinical stability, normal sensorium and good cough reflex) and failing a T-piece trail because of a rise in PaCO2 (\>20% from baseline) and/or a rapid shallow breathing index (f/VT)\> 100.

After the unsuccessful trial they will be reconnected to the ventilator and they will repeat hours later the same T-piece trial once the extracorporeal CO2 removal device (DeCap) will be connected via a double lumen catheter in the femoral vein.

The investigators aim to verify whether using the DeCap) the investigators will be able to avoid at the end of the T-piece trial the criteria of failure. If so, the patient will be extubated and DeCap will be continued when all of the following were achieved for at least 12 hours: respiratory rate less than 25 breaths/min; pH greater than 7.35; Paco2 less than 20% of the baseline value; and absence of use of the accessory muscles or paradoxical abdominal movements.

Eligibility Criteria:
Inclusion Criteria:

* Patients meeting the criteria for readiness to be weaned (i.e. clinical stability, FiO2\<50%, normal sensorium, body temperature \< 38 and satisfactory cough reflex)
* Failing a T-piece trial after 1 hour or before for a rise in PaCO2\>20% from baseline and with f/VT ratio \>100

Exclusion Criteria:

* Patients NOT meeting the criteria for readiness to be weaned
* Patients succeeding a T-piece trial