cyrilzakka/clinical-trials huggingface dataset:
Memory Preservation of Prophylactic Cranial Irradiation With Hippocampal Avoidance (PREMER-TRIAL)

The main objective of this study i sto evaluate the impact of prophylactic cranial irradiation (PCI) with hippocampal avoidance in the neurocognitive function and quality of life of small cell lung cancer patients.

In addition, the trial assesses the potential changes in hippocampal volumetry due to cranial irradiation using magnetic resonance imaging.

Prophylactic cranial irradiation (PCI) has become a standard of care for selected patients with limited and extensive stage small cell lung cancer (SCLC) who have shown benefit after chemotherapy with or without thoracic radiotherapy.

Because hippocampal involvement by metastatic disease is rare, and because preclinical and clinical evidence suggests that radiation dose received by the hippocampus during whole brain radiotherapy may play a role in radiation-induced neurocognitive decline, sparing of the hippocampus during the administration of PCI should result in lower rates of memory loss.

Previous studies have demonstrated the dosimetric capabilities of intensity modulated radiation therapy (IMRT) to conformably avoid the hippocampus without detriment to the radiation dose the remaining brain receives.

The main objective of this trial is compare neurocognitive functioning following hippocampal avoidance PCI to standard PCI treatment measured by Free and Cued Selective Reminding Test (FCSRT). The FCSRT measures verbal learning and memory. The FCSRT emphasizes encoding specificity during learning and recall. One of the secondary objectives of this trial is to test the hypothesis that the lowered neurocognitive function of the patients is due to a substantial reduction in hippocampal volume in magnetic resonance imaging (MRI). Others objectives are to evaluate quality of life (QoL) and the rate of metastases in the hippocampus.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosed cytological or histologically confirmed Small cell lung carcinoma (stage I-IV) candidate for PCI, for example, without progressive disease after chemo-radiotherapy in stage I-III or after response after chemotherapy in stage IV
* Performance status ≤ 1
* Negative MRI of the brain within one month before protocol entry
* Patient must give written informed consent before registration

Exclusion Criteria:

* Prior radiotherapy to the brain
* History of brain metastases
* Pregnancy or lactation
Inverted Internal Limiting Membrane Flap Technique for Macular Hole Retinal Detachment in Highly Myopic Eyes

To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography (OCT)

Macular hole retinal detachment (MHRD) threatens a certain number of highly myopic patients for irreversible visual dysfunction, and mostly requires immediate surgical intervention. The aim of they study is to evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for MHRD in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography.

Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria were patients who underwent vitrectomy and internal limiting membrane removal or inverted for macular hole retinal detachment and had followed for more than 6 months.

Exclusion Criteria:

* The patients with follow-up less than 6 months.
Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers

The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).


Eligibility Criteria:
Inclusion Criteria:

* infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry

Exclusion Criteria:

* who previously received any meningococcal vaccine;
* who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
* who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
* Subjects with any serious, acute or chronic progressive disease
Tap Water Versus Normal Saline for Wound Irrigation

This study is designed to compare the infection rates in wounds irrigated with sterile normal saline to those irrigated with chlorinated tap water. The hypothesis is that the wound infection rate subsequent to irrigation with tap water is not significantly different than the infection rate for wounds irrigated with sterile normal saline.

Inclusion criteria are patients older than 1-year of age who present to the emergency department with a soft-tissue laceration requiring repair. Exclusion criteria include patients with any underlying immunocompromising illness, current use of antibiotics, puncture or bite wounds, underlying tendon or bone involvement, or wounds more than nine hours old.

Patients are randomized to have their wounds irrigated either with tap water or sterile normal saline prior to closure, controlling for the volume and irrigation method used. Structured follow-up is completed at 48 hours and 30 days to determine the presence of infection.

The primary outcome measure is the difference in wound infection rates between the two randomized groups.


Eligibility Criteria:
Inclusion Criteria:

• Patients older than 1-year of age, who presented to the ED with an uncomplicated soft-tissue laceration requiring repair.

Exclusion Criteria:

* Diabetes mellitus
* Asplenism
* primary immune disorder
* Mechanical heart valve
* Chronic alcoholism
* Steroid use,
* Antibiotics use
* Immunosuppressive chemotherapy
* Wounds older than 9 hours or from a human or animal bite
* Puncture wounds
* Wounds associated with bone, tendon, or neurovascular injury
Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.

Investigator examines the past prescription patterns and the reasons for the change of prescription to Monterizine capsules for Perennial Allergic Rhinitis patients with Asthma who will be taking Monterizine capsules to treat allergic rhinitis.

After being given Monterizine capsules, Investigator evaluates the therapeutic effectiveness and safety for 3 months (or 6 months).

A Multi-center, Prospective, Observational Study

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged ≥ 15 years
2. Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis
3. Patients who provided a signed written informed consent form

Exclusion Criteria:

1. Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives
2. Patients with renal failure(CLCR,10ml/min) and hemodialysis patients
3. A female who is pregnant, may be pregnant, or is lactating
4. Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
The Effect of Vitamin A With and Without Zinc and Multivitamin Supplementation on Malaria Morbidity in Ghanaian Children

The aim of this study was to determine the effect of combining vitamin A (VA), zinc (Z) and multivitamins (MV- A, B1, B2, B6, B12, C, D and E) on malaria morbidity

A total of 542 children aged between 6-59 months received either: (i) VA (control) or (ii) VA \& Z (VAZ) or (iii) VA, Z \& MV (VAZM). VA was delivered as a single dose while MV and Z were delivered daily. Malaria cases were managed by community health workers, who used rapid diagnostic test to confirm infection prior to treatment.

Eligibility Criteria:
Inclusion Criteria:

* under 5years
* will stay in the community for 10years

Exclusion Criteria:

* chronic diseases
Mammographic Density and the Risk of Tumor Recurrence in Asian Women: a Case-control Study

To evaluate the influence of mammographic breast density at diagnosis on the risk of cancer recurrence and survival outcome in patients with invasive breast cancer after surgery


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with invasive breast cancer between 2004 and 2009 who had undergone surgery and had the mammographic breast density ascertained before, or at, diagnosis.

Exclusion Criteria:

* Women diagnosed with invasive breast cancer between 2004 and 2009 who had not undergone surgery or who had no mammographic breast density ascertained before, or at, diagnosis.
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap

Non-randomized study of robot-assisted perineal reconstruction with rectus abdominis muscle flap in patients operated with abdominoperineal resection for irradiated locally advanced rectal or anal cancer. Operative time, complications, wound healing, pre- and postoperatively abdominal wall strength and patient related outcomes including sexual health will be registered.

Inclusion criteria:

Patients \> 18 years of age operated with robotic-assisted abdominoperineal resection for irradiated locally advanced rectal or anal cancer where robotic-assisted perineal and/or vaginal reconstruction has been performed with a rectus abdominis muscle flap.

Methods Up to 40 patients operated with robotic-assisted abdominoperineal resection with Da Vinci Xi surgical system (Intuitive Surgical, Sunnyvale, California, USA) and robotic-assisted reconstruction with a pedicled rectus muscle will be included in this prospective, non-randomized study.

In addition to the standardized post-operative care for patients with locally advanced rectal or anal cancer as specified by national guidelines, patients will be offered study-specific follow-up visits at 1, 6 and 12 months.

Complications are recorded by the accordion severity grading system of surgical complications. Patient related outcomes measures will be registered by using European organization for research and treatment of cancer Quality of life questionnaire Core 30 (EORTC QLQ-C30). Sexual health will be registered by a subset of questions from European organization for research and treatment of cancer Quality of life questionnaire Sexual health (EORTC QLQ-SH22).

Primary endpoint:

- perineal wound healing at 3 months

Secondary endpoints:

* early (\< 30 days) and late (\> 30 days) complications
* quality of life preoperatively and at 3- and 12 months postoperatively
* sexual function preoperatively and at 3- and 12 months postoperatively
* clinical evaluation of abdominal wall strength preoperatively, at 3- and 12 months postoperatively

Eligibility Criteria:
Inclusion Criteria:

* patients with rectal or anal cancer
* scheduled for robot-assisted abdominoperineal resection
* reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap

Exclusion Criteria:

* patients not eligible for robot-assisted procedure
* rectus abdominis muscle not available for harvest
* the expected wound defect is not suitable for reconstruction with rectus abdominis muscle flap
Rotation or Change of Biotherapy After TNF Blocker Treatment Failure for Axial Spondyloarthritis

Axial spondyloarthritis (axSpA) is a chronic inflammatory disease characterized by inflammatory arthritis and enthesitis involving the spine. AxSpA prevalence is around 0.17% of the French population. Tumor necrosis factor (TNF) was the first target defined in axSpA. Since one third of axSpA patients failed to the first TNF blocker, many axSpA patients received a second biological Disease-Modifying AntiRheumatic Drugs (bDMARDs). Until few months, the only choice was to use a second TNF blocker.Since 2003, pharmaceutical companies investigated efficacy of TNF blockers already used in rheumatoid arthritis. Etanercept is a fusion protein with TNF receptor type II p75 and IgG1 Fc fragment, whereas adalimumab, infliximab, and golimumab are monoclonal antibodies. Certolizumab is a fusion between a fab fragment targeting TNF and a Peg fraction. All demonstrated efficacy versus placebo in a randomized double blinded study

In case of failure to the first TNF blockers, rheumatologists will follow the "Treat-to-Target" principle. This approach already demonstrated its benefit in rheumatoid arthritis or in psoriatic arthritis. This concept was also suggested for axSpA with low levels of evidence and recommendation. So rheumatologist will provide the best treatment in case of failure to the first TNF blockers, which is a daily clinical situation. Since few months, rheumatologists have the choice between targeting IL-23/17 axis compared to a second TNF blocker.


Eligibility Criteria:
Inclusion Criteria:

* Active axSPA with BASDAI\>4 or ASDAS\>3.5, who need change in TNF blocker treatment
* Aged over 18 years
* Inadequate response after at least 3 months to the 1st TNF blocker
* If non biologic DMARD treatment : stable dose for at least on month before inclusion
* If oral corticosteroids treatment : stable dose for at least on month before inclusion
* If NSAIDs treatment : stable dose for at least on month before inclusion
* Ability to complete questionnaires
* Social security affiliation
* Informed written consent given

Exclusion Criteria:

* Any contra-indication to TNF blocker and/or secukinumab
* Inflammatory bowel diseases
* Existing pregnancy, lactation, or intended pregnancy within the next 15 months Active tuberculosis or other severe infections such as sepsis or opportunistic infections
* Active infections, including chronic or localised infections.
* Moderate to severe heart failure (NYHA classes III/IV)
* Impossibility to give informed consent
* Impossibility to be followed for 12 months
Swallowing Disorders in Geriatrics Studied With Respiratory Plethysmography by Inductance

The purpose of this study is to evaluate the efficiency of a novel non-invasive method for swallowing disorders detection in geriatrics.

Interest: swallowing disorders exist at any age. More common among the elderly, their prevalence is estimated at between 15 and 50% of more than 60 years. Recognized today as a health problem of particular concern within this population, their pathological consequences are multiple and severe: inhalation pneumonia, often a complication of "the wrong track", was recognized in the USA in 1989, as 5th cause of death among patients aged 65, and the 3rd leading cause of death of patients over 85 years. Malnutrition facilitates infections by depression of the immune system and promotes the development of bedsores. The swallowing disorders resulting in an increase in the prevalence of dehydration, social isolation, but also an increase in mortality. Faced with such consequences, it is therefore necessary to have a reliable, non-invasive approach adapted to the fragility of the elderly to detect these disorders in order to promote preventive strategies and / or curative justified.

Originality: This work, which is part of a clinical approach uses a new method of swallowing study, described in A. Moreau-Gaudry's Medicine thesis : "Assets of the respiratory inductance plethysmography to the study of swallowing in geriatrics." The originality of this lies in the combination of Respiratory Plethysmography by inductance (RPI) to the informatic tool. The PRI allows continuous recording, thanks to a vest connected to a laptop, the patient's breathing rate. Readily available at the patient's bedside, it is non-invasive and perfectly suited to the fragility of the study population. The tool, by its automatic guarantees objectivity and reproducibility of the analysis of deglutitions from respiratory signal provided by the RPI.

Eligibility Criteria:
Inclusion Criteria:

* Patients major, consenting, cooperating.
* Person registered with the French Social Security or benefiting from an equivalent health insurance system

Exclusion Criteria:

* Patients do not qualify for inclusion pre-cited,
* Patients in a period of exclusion for other studies,
* Patients with behavioural problems that prevent them joining a clinical trial requiring prolonged collaboration (state of rest with minimal mobilization of the patient, a necessary condition to acquire a breathing rate of quality, and therefore an analysis of quality),
* Patient suffering from a nosocomial infection,
* Patient the acute stage of a condition involving the life of the latter,
* Patient insufficient breathing, oxygen, with respiratory failure poorly supported despite oxygen,
* Patient in respiratory failure decompensated
* Patient at the end of life
A Comparison of the Analysis of the Force on the Supporting Legs of Female Athletes of Different Levels Playing Football

In this study, we grouped athletes into different training levels, and tested the force on the supporting legs of female athletes at different times when they kicked the ball.

In this study, first we divided the subjects into three levels: A, B, and C. After fully warming up, we asked the subjects to perform five full kicks. The kicking process was captured with a Vicon high-speed camera. The data captured by the motion capture system was then analyzed to analyze the angles, angular velocity, linear velocity, and ground reaction force of the hip, knee, and ankle joints of the hip, knee, and ankle supporting legs of female athletes of different levels during full kicks. Finally, the subjects of different levels are analyzed to find the significant differences in the supporting legs of female football players of different levels.

Eligibility Criteria:
Inclusion Criteria:

* Master kicking skills Have not suffered any injury of lower limbs in the past six months

Exclusion Criteria:

* Unable to complete the kick Has suffered a lower limb injury in the past six months
Effects of Oxytocin on Reinforcement Learning and Interoception

The main aim of the study is to investigate whether intranasal oxytocin has effects on reinforcement learning under dynamic environment and interoceptive processing based on behavioral and electroencephalogram (EEG) responses.

A double-blinded, placebo-controled, between-subject design is employed in this study. In a randomized order, a total of 80 healthy males are instructed to self-administrated intranasal spray of oxytocin or placebo. (1) Participants first complete a probabilistic reward learning task 45 minutes after treatment with behavioral (response time and accuracy) and EEG data (ERP components such as FRN, ERN and P300) being collected during this task. (2) A resting-state recording and a heartbeat counting task are conducted following the learning task with ECG and EEG data being collected. Personality traits of subjects are assessed using validated Chinese version questionnaires including the Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), the Cognitive Flexibility Inventory(CFI), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), Behavioral Inhibition System and Behavioral Activation System Scale (BIS/BAS). Subjects are asked to complete Positive and Negative Affect Schedule (PANAS) when they just arrive, before and after the tasks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without any past or present psychiatric or neurological disorders.

Exclusion Criteria:

* History of brain injury medical or mental illness.
Microfracture With Platelet Rich Plasma Gel Injection for Osteochondral Lesion of the Talus

The goal of this clinical trial is to learn if combined local injection of platelet rich plasma (PRP) gel adds clinical efficacy to isolated arthroscopic microfracture in treatment of osteochondral lesion of the talus (OLT). The interface integration of the injured area will also be assessed via radiographic follow-up. The main questions it aims to answer are:

* Does arthroscopic microfracture combined with PRP gel injection improve ankle function of participants based on American Orthopedic Foot and Ankle Society (AOFAS) Score?
* Does arthroscopic microfracture combined with PRP gel injection improve interface integration of the injured cartilage on magnetic resonance imaging (MRI)? Researchers will compare arthroscopic microfracture with concomitant local injection of PRP gel to isolated microfracture to see if intraoperative PRP gel injection adds clinical efficacy to isolated arthroscopic microfracture in treatment of OLT.

Participants will:

* Undergo either isolated arthroscopic microfracture or microfracture with intraoperative injection of PRP gel
* Receive clinical follow-up 3, 6, 12, and 24 months after surgery and answer scales of ankle function assessment
* Take MRI preoperatively and 6, 12 and 24 months after surgery


Eligibility Criteria:
Inclusion Criteria:

* Chronic ankle pain, diagnosed as osteochondral lesion of the talus;
* Lesion size ≤ 1.5 cm2 or the diameter of the lesion ≤ 1.5 cm;
* Conservative treatment of at least 3 months fails to relieve symptoms;
* Willingness to voluntarily participate in the trial and to sign informed consent.

Exclusion Criteria:

* Varus or valgus deformity of the ankle of more than 5 degrees;
* Grade III injury of the lateral collateral ligament of ankle;
* Chronic synovitis (rheumatoid arthritis, pigmented villous nodular synovitis, etc.);
* Joint fibrosis, stiffness, and significantly restricted range of motion;
* Evidence of moderate to severe knee osteoarthritis on plain radiographs;
* Failure to complete the rehabilitation protocol as required;
* Patient medically not fit for surgery, radiographs or MRI;
* For women, pregnant, planning to be pregnant or lactating.