cyrilzakka/clinical-trials huggingface dataset:
Influenza Vaccine in HIV Study

The aims of this study are:

1. to investigate if HIV infection alters the antibody responses to influenza and
2. to assess the ability of licensed influenza vaccine to induce functional non-neutralising antibodies in HIV-infected and HIV-uninfected subjects.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 positive by licensed diagnostic test (for HIV-positive group only)
* Planning to receive the seasonal influenza vaccine outside the study
* Provision of written informed consent

Exclusion Criteria:

* Previous allergy to influenza vaccination
* Pregnancy or planning to become pregnant
* Unwilling or unable to provide blood samples
Group Parent Training for Adolescent Eating Disorders

While parents are considered essential for the effective treatment of adolescents with anorexia nervosa, the most effective manner to involve parents in treatment is unknown. Given reports of high caregiver burden among parents of this clinical group, finding treatments that minimize parent burden while improving the child's eating disorder symptoms is essential.

This investigation will examine the preliminary effectiveness of a parent skills group and adolescent skills group compared to family therapy for the treatment of adolescent anorexia nervosa. The target of this intervention is the improvement of eating disorder symptoms in the child and improving self-efficacy, emotion regulation, and perceived burden in the parent.

The effectiveness of this experimental treatment group (Group Parent Training for the parents/Adolescent Skills Training for the adolescent) will be compared to the Maudsley model of family therapy. The effectiveness of the group program will be examined by exploring changes within individuals over time as well as via comparisons across treatment conditions. Results from this investigation will be used to calculate treatment effect sizes in the design of a larger, fully powered, randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* age 11-18 years old
* living at home
* meet criteria for anorexia nervosa or subthreshold anorexia nervosa

Exclusion Criteria:

* no active psychosis
* no current suicidality
* medically safe for outpatient treatment
Alternating and Direct Current Stimulation for Neuropathic Eye Pain

The goal of this clinical intervention is to test if two forms of transcranial current stimulation, transcranial direct current stimulation (tDCS) or transcranial alternating current stimulation (tACS) can alleviate neuropathic eye pain in a sample of 20 patients.

The main aims are:

* Test if tDCS/tACS can alleviate neuropathic eye pain and/or other cerebral symptoms: brain fatigue, migraine, light sensitivity, etc.
* Test if one stimulation method is superior to the other Patients will be treated for a total of fifteen 30-minute stimulation sessions, three times a day over a five-day period, each stimulation separated by approximately 4 hours, with either active tACS or tDCS over the scalp corresponding to primary sensory and motor areas.

The patients will have questionnaires to monitor subjective experiences and pupillometry before and after treatment to monitor experimental outcomes.

Brief Summary sufficient

Eligibility Criteria:
Inclusion Criteria:

* persistent eye pain for at least 6 months
* average eye pain intensity of 4 or more on a 0-10 numerical rating scale
* naive to transcranial stimulation
* eye pain having neuropathic-like characteristics

Exclusion Criteria:

* contraindication to transcranial stimulation (i.e., pacemaker, cardioverter defibrillator, neuro-stimulation (brain or spinal cord), bone growth stimulations, indwelling blood pressure monitors, epilepsy, pregnancy)
* presence of ocular diseases that are the likely cause of pain (i.e., corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, etc.)
* current participation in another study with an investigational drug or device within one month prior to screening
NutriCovid30 : Nutritional Evaluation for Covid-19 Infection at D30

Describe the main clinical features impacting the food intake, and therefore the nutritional status of a population infected by a coronavirus.

The recent Covid-19 outbreak has brought USA, European, British and French nutrition learned societies to publish recommendations for the nutritional management of patients infected with the SARS-CoV-2. They reminded that there is a risk of malnutrition for that population.

The emergency and rapid evolution in the situation have led to severe cases of anosmia, ageusia, diarrhea, odynophagia, anorexia etc.. Some of the first patients cured from Covid-19 have lost up to 10 kgs.

To this day, there is no available information regarding either nutritional characteristics or nutritional interventions (enteral or parenteral nutrition, oral nutritional supplements, dietary supplementations) for Covid-19 patients.

The objective of this study is to describe nutritional consequences of the Covid-19 infection for adults, 30 days after their discharge from hospital, as well as the nutritional care they received.

Type and proportion of chronic diseases will be assessed in this trial.

Eligibility Criteria:
Inclusion Criteria:

* 30 days or more after discharge from hospital for Covid-19
* Patient received information about the trial and gave his/her consent
* Patient capable of answering the phone (alone or with some help)

Exclusion Criteria:

* Patient diseased
* impossibility to collect information from the patient or one of his/her relatives
* Patient protected by the French Public Health Code (art. L1121-5 à L1121-8)
68Ga-labeled NY105 PET Imaging in Patients

This is a single arm study to evaluate the safety and biodistribution of 68Ga-labeled NY105 PET Imaging in patients


Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Age 18-75, male or female;
3. Patients diagnosed with cancer confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. ECOG score 0\~3.

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
4. Patients with autoimmune diseases, including rheumatoid arthritis;
5. Inadequate control of arrhythmias, including atrial fibrillation;
6. Uncontrolled hypertension;
7. Patients with allergies or allergies to any component of the imaging agent or antibody;
8. Patients who cannot undergo PET/CT imaging scan;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.
A Herbal Compound for Eczema

The goal of this interventional clinical trial study is to compare ZAX.1400.EC.02 and placebo in Eczema patients. The main question it aims to answer is:

• Can treatment with ZAX.1400.EC.02 for 3 weeks improve clinical signs of skin in Eczema patients? Participants will be divided into two groups. One group will use ZAX.1400.EC.02 topically twice daily for 3 weeks and the other group will use placebo topically twice daily for 3 weeks.

Researchers will compare treatment and placebo groups to see if there is any improvement in the clinical signs of skin caused by Eczema after treatment with ZAX.1400.EC.02 for 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of the disease by a doctor
* Age range between 18 and 60 years
* Both sexes (male and female)
* Having written informed consent to participate in the study
* Lack of allergy to food and health products
* Absence of underlying diseases and immune deficiency
* Absence of pregnancy and breastfeeding
* Absence of blisters and infection caused by the disease

Exclusion Criteria:

* Non-consent of the doctor directly responsible for the patient
* Incidence of drug product allergy
* Occurrence of symptoms of skin, digestive, liver or kidney diseases
* Patients lack of consent to continue for any reason
Epidemiology of Sudden Cardiac Arrest in Sub-Saharan Africa: Rationale and Design

Background The burden of sudden cardiac death (SCD) in Africa is unknown. Our aim is to assess the epidemiology of SCD in Africa. Methods The sub-Saharan Africa SCD study is a prospective, multicenter, community-based registry monitoring all cases of cardiac arrest occurring in victims \> 15 years old. Investigators will use the definition of established SCD if an unexpected death without obvious extracardiac cause, occurred with a rapid witnessed collapse, or if unwitnessed, occurred within 1 hour after the onset of symptoms; probable SCD if an unexpected death without obvious extracardiac cause occurred within the previous 24 hours. After approval from institutional boards, Investigators will record demographic, clinical, electrocardiographic and biological variables of SCD victims (including survivors of cardiac arrest) in several sub-Saharan African cities. All deaths occurring in residents of districts of interest will be checked for past medical history, circumstances of death, and autopsy report (if possible). Investigators will also analyze the employment of resuscitation attempts during the timeframe of sudden cardiac arrest (SCA) in various patient populations throughout countries. Conclusion This study will provide comprehensive, contemporary data on the epidemiology of SCD in sub-Saharan Africa and will help in the development of strategies to prevent and manage cardiac arrest in this region of the world.


Eligibility Criteria:
Inclusion Criteria:

* Victims of cardiac arrest, either SCD or aborted SCA

Exclusion Criteria:

* Age ≤ 15 years.
* Refusal of consent (by the family).
Chronic Inflammatory Bowel Diseases (IBD) and School Absenteeism

Study of the causes and rate of school absenteeism in children and adolescents with Inflammatory Bowel Disease.


Eligibility Criteria:
Inclusion Criteria:

* Child aged 6 to 18 years old
* Child with definite diagnosis of IBD for at least 6 months
* Follow-up by a gastroenterologist of Rennes University Hospital on a regular basis (at least 2 annual consultations)
* Non-opposition of the child and the parents

Exclusion Criteria:

* School leaving
* Student at the University
* Other serious disease outside IBD preventing normal schooling
* Refusal of participation
MultiStem Administration for COVID-19 Induced ARDS (MACoVIA)

Multicenter investigation featuring an open-label lead-in followed by a double blinded, randomized, placebo-controlled Phase 2/3 part to evaluate the safety and efficacy of MultiStem therapy in subjects with moderate to severe Acute Respiratory Distress Syndrome (ARDS) due to pathogens including COVID-19.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of new acute-onset moderate to severe ARDS, as defined by the Berlin criteria, requiring an endotracheal or tracheal tube, Evidence of pneumonia or severe localized or systemic infection

Exclusion Criteria:

Moribund subject who, in the opinion of the Investigator, is not expected to survive at least 48 hours and End-stage severe chronic lung disease
Effects of Methylphenidate on Cellular Abnormalities in Children With Attention Deficit Hyperactivity Disorder (ADHD)

This study will assess the frequency of chromosomal abnormalities measured in circulating lymphocytes in treatment-naive children with Attention Deficit Hyperactivity Disorder (ADHD) treated for 3 months with either extended release methylphenidate or behavioral therapy.

This study will determine whether the administration of extended-release methylphenidate in treatment-naïve children with Attention Deficit Hyperactivity Disorder (ADHD) affects the frequency of chromosomal abnormalities.

Eligibility Criteria:
Inclusion Criteria:

* Children of both genders, 6-12 years old
* Written informed consent by the parent and the patient (over 7)
* Diagnosis of ADHD
* Age-appropriate cognitive functioning
* All patients who had at least one post-baseline cytogenetic assessment in the core study can enter the observation phase.

Exclusion Criteria:

* History of malignant neoplasm
* History of seizures (except childhood febrile seizures)
* Hyperthyroidism
* Concurrent medical condition which may interfere with study

Other protocol-defined inclusion/exclusion criteria may apply
Autologous Adipose Mesenchymal Stem Cell Transplantation in the Treatment of Patients With Hemifacial Spasm

Main purpose：In the face of listening to nerve injury at early stage, utilizing autologous adipose stem cell transplantation in the treatment of makes the acceptance micro vascular decompression hemifacial spasm patients to nerve function to obtain a better recovery.

Secondary purpose ：To clarify the efficacy of stem cells in the treatment of cranial nerve dysfunction, and to provide evidence for the treatment of other cranial nerve dysfunction.

Cases in group：Appearing on the surface of microvascular decompression for hemifacial spasm to decrease neural electrophysiological index of patients research design：Single center, prospective, randomized, double-blind, controlled Observation index：Facial nerve clinical score, facial nerve muscle compound action potential, electrical measurement, cerebrospinal fluid index Evaluation of therapeutic effect：Facial nerve function evaluation (House-Brackmann classification, facial nerve function classification scale SFGS), facial nerve electrophysiology evaluation (facial nerve muscle compound action potential), electric measurement Safety evaluation：Clear evaluation of hemifacial spasm and micro vascular decompression were listening to nerve in intracranial segment wrapped around the autologous fat stem cell therapy overall safety and evaluation methods including adverse events, laboratory tests, vital signs, electrocardiogram.


Eligibility Criteria:
Inclusion Criteria:

1. the age of 18 \~ 80 years old;
2. no surgical contraindications, accept facial nerve microvascular decompression surgery;
3. to enter into the group's informed consent and sign the consent form for clinical research.
4. patients with preoperative facial nerve electrophysiology examination without facial paralysis
5. patients with preoperative electrical testing without hearing impairment

Exclusion Criteria:

1. patients with poor compliance;
2. major surgical complications and interruption of treatment;
3. brain magnetic resonance examination or blood test results abnormal and clinical significance;
4. clinical trials of other drugs within 30 days;
5. the unintended side effects;
Comparison of Laminaria and Misoprostol for Cervical Preparation Before Second Trimester Surgical Abortion

This study compares the effectiveness of cervical preparation before second trimester abortion using laminaria versus vaginal Misoprostol.

The investigators hypothesize that medical preparation of the cervix with vaginal Misoprostol is superior to mechanical preparation using laminaria.

The investigators believe that medical preparation makes the procedure easier to perform, equally safe, without addition of pain or discomfort.

This is a prospective randomized study.

The aim of the study is to compare preparation of the cervix before surgical abortion with laminaria and misoprostol.

Primary outcome measures will include:

Initial cervical opening and the need for further dilatation at the procedure Procedure duration

Difficulty score performing the abortion

Complications during and after the procedure

Assessment of pain, using VAS scale, and the need for analgesia before and after the procedure

Eligibility Criteria:
Inclusion Criteria:

* Pregnant patients with a viable singleton
* Pregnancy 14-20 weeks of gestation
* Admitted for termination of pregnancy

Exclusion Criteria:

* Contraindication for administration of Misoprostol
* Patients with more than one previous cesarean section scar
* Patients with impaired coagulation
* Significant pulmonary or cardiac disease
* Non viable pregnancy
* Placenta accreta or previa by ultrasound
Alternative Prophylaxis in Female Recurrent Urinary Tract Infections

Urological pathogens are effected by rising antimicrobial resistance rates due to the frequent use of antimicrobials for treatment and prophylaxis. Intravesical instillation with hyaluronic acid (HA) and chondroitin sulphate (CS) obtained positive outcomes in the treatment of overactive bladder, radiation cystitis and interstitial cystitis by replenishment of the glycosaminoglycan layer of the bladder. This study is to investigate whether intravesical instillation with HA-CS in patients with recurrent urinary tract infections (rUTI) is superior to a placebo instillation in terms of reduction of rate of symptomatic urinary tract infections (UTIs) (based on clinical diagnosis) needing treatment with antimicrobials within 12 months after randomisation.


Eligibility Criteria:
Inclusion Criteria:

* Documented history of rUTI, defined as ≥ 3 episodes of (un)complicated UTI documented by urine culture with the isolation of ≥103 cfu/ml of an identified pathogen in the last year with clinical symptoms OR 2 episodes in the last 6 month

Exclusion Criteria:

* No informed consent
* Concomitant UTI (\< 7 days prior to randomisation)
* Ongoing antimicrobial prophylaxis (e.g. for rUTI or for any other reason like endocarditis, transplanted patients under immunosuppression)
* Ongoing prophylactic strategy (e.g. immunoactive prophylaxis)
* Documented underlying urogenital abnormality (e.g. significant post voiding residual volume (\>50 ml), urethral stricture, urethral diverticula, urinary stone, reflux, urinary neoplasia), urological device (e.g. catheter, ureteral stent) or symptomatic pelvic floor disorder (e.g. genital prolapse stage ≥ II)
* Concomitant disease (i.e. renal insufficiency, diabetes mellitus, corticosteroid use)
* Urogenital urological or gynecological surgery \< 6 weeks
* Known allergy to the study medication
* Use of spermicides or intrauterine device
* Pregnancy
Injection of Tenoxicam Versus Arthrocentesis Alone in the Treatment of Temporomandibular Joint Osteoarthritis

The aim of the study is to examine the effectiveness of arthrocentesis plus tenoxicam injection and to compare it with arthrocentesis alone in patients with TMJ-OA.

Thirty patients with TMJ-OA who were treated randomly with either arthrocentesis plus tenoxicam injection (TX group) or arthrocentesis alone (control group) were examined. Maximum mouth opening (MMO), visual analog scale (VAS) pain values, and joint sounds were the outcome variables, which were evaluated at pre-treatment and at 1, 4, 12, and 24 weeks after treatment.

Temporomandibular joint osteoarthritis (TMJ-OA) is a very painful disease that disrupts the patient's comfort of life. Arthrocentesis alone or in combination with intraarticular injections is highly effective in the treatment of TMJ-OA. It reduces pain, increases mouth opening, and improves jaw movements. In intra-articular injections, hyaluronic acid, platelet-rich plasma, corticosteroids, and non-steroidal anti-inflammatory drugs (NSAIDS) are used. Tenoxicam is an NSAID that is used systemically or locally in joint diseases such as acute or chronic inflammatory rheumatoid arthritis and osteoarthritis. It has been reported that its long-lasting analgesic effect and anti-inflammatory effect are higher in intra-articular administration than in oral and intravenous administrations , to our knowledge, there has been no such study analysing the effectiveness of intra-articular application of tenoxicam in patients with TMJ-OA. The aim of the study is to examine the effectiveness of arthrocentesis plus tenoxicam injection and to compare it with arthrocentesis alone in patients with TMJ-OA.

Thirty patients with TMJ-OA who were treated randomly with either arthrocentesis plus tenoxicam injection (TX group) or arthrocentesis alone (control group) were examined. Maximum mouth opening (MMO), visual analog scale (VAS) pain values, and joint sounds were the outcome variables, which were evaluated at pre-treatment and at 1, 4, 12, and 24 weeks after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological diagnosis of TMJ-OA
* 18 years of age and older
* Sufficient clinical data at baseline and follow-up.

Exclusion Criteria:

* Uncontrolled systemic disease
* Neurological disease
* Previous TMJ surgery
* Malignant disease in the head and neck region
Combining Tongue and Gastric Cancer Cascade With Artificial Intelligence

This study combines artificial intelligence with tongue images, by collating and collecting tongue images and diagnostic and pathological results of gastroscopic diseases, mining and analysing the correlation between tongue images and OLGA, OLGIM stages, Correa sequences and constructing prediction models, to deeply investigate the relationship between tongue images and precancerous diseases, precancerous lesions and gastric cancer.

Firstly, tongue pictures and patient information will be collected after the patient signed an informed consent form.

Secondly, after the patient undergoes gastroscopy, patient gastroscopy reports and pathology reports will be obtained.

Thirdly, the investigator will assess the patient's gastroscopy report for the Correa sequence of gastric cancer with OLGA and OLGIM staging.

Finally, the patient's tongue image, information and gastric cancer cascade response are matched to construct an artificial intelligence model and assess the quality of the model.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 40 and 80 years of age who are scheduled for gastroscopy.
* Patients all gave their informed consent and signed the informed consent form.

Exclusion Criteria:

* Persons with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who are unable to participate in gastroscopy.
* Patients with previous surgical procedures on the gastrointestinal tract.
* Patients taking bismuth or other staining drugs.
Cytokine-induced Killer Cell Immunotherapy for Surgical Resected Stage III Colorectal Cancer Patients After Chemotherapy

We hypothesize through this randomized, prospective, single center adjuvant study, that cytokine-induced killer cell in patients with stage III colon cancer can improve survival in this patient population over control. Stage III colon cancer patients can benefit most from adjuvant chemotherapy, but the 5 year survival rate is still around 60%. We wish CIK cell therapy can improve the survival rate of stage III colon cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent
* Stage III colon cancer
* undergone complete resection of primary tumor
* Completed standard adjuvant chemotherapy
* within 120 days of completion of standard therapy
* ECOG performancer status 0-2
* Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
* ANC ≥ 1.0 x 109/L
* Platelets ≥ 100 x 109/L
* Creatinine clearance ≥ 30 mL/min
* Total bilirubin ≤ 2.0 x the upper limit normal
* AST \& ALT ≤ 5 x the upper limit normal
* Completed the following investigations
* Completed the following investigations

Exclusion Criteria:

* HIV positive or other Immunodeficiency disease
* recently use of high dose glucocorticoid
* Uncontrolled hypertension (untreated systolic blood pressure \> 160 mmHg, or diastolic blood pressure \> 95 mmHg)
* History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
* Patient having known allergy to capecitabine or Oxaliplatin
* Pregnant, lactating