cyrilzakka/clinical-trials huggingface dataset:
Persistence of Rabies Antibody 1-5 Years After the Post-exposure Prophylaxis With Vero Cell Antirabies Vaccine and Antibody Response to a Single Booster Dose

This study is to investigate the persistence of rabies Chinese manufactured antibody 1-5 years after the post-exposure prophylaxis with vero cell antirabies vaccine and antibody response to a single booster dose. A total of 160 subjects would be enrolled. These subjects were all administered ChengDa antirabies vaccine from 2005 to 2009. After informed consent is obtained, these subjects would be tested for their antirabies antibody titer and given a single booster dose. Seven and 14 days later, the investigators would re-evaluate the antibody titer.


Eligibility Criteria:
Inclusion Criteria:

* 20 to 60 years old
* Healthy
* Given ChengDa rabies vaccine
* Good compliance
* Obtained informed consent

Exclusion Criteria:

* Other than inclusion criteria
Clinical Efficacy of Heparin and Tocilizumab in Patients With Severe COVID-19 Infection

The COVID-19 infection primarily manifests itself as a respiratory tract infection, although new evidence indicates that this disease has systemic involvement involving multiple systems including the cardiovascular, respiratory, gastrointestinal, neurological, hematopoietic and immune systems. Recent studies have shown that in its pathophysiology, inflammation and thrombogenesis predominate, especially in the severe forms of COVID-19. Thus, the investigators hypothesized that the use of heparin and tocilizumab could potencially reduce inflammation and thrombogenesis in patients with severe COVID-19 infection, improving patients outcomes and survival.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Informed consent form signed by the patient or guardian or by audio with the guardian;
* Positive result for COVID-19 in PCR (polymerase chain reaction) in nasopharyngeal swab or tracheal secretion up to 10 days before the inclusion and radiological evidence of COVID-19, by chest radiography or chest computed tomography;
* Need for ≥ 4 L of supplemental oxygen to maintain peripheral oxygen saturation equal to or greater than 93% or need for invasive mechanical ventilation.

Exclusion Criteria:

* Risk of bleeding:

  * Clinical: active bleeding, major surgery in the last 30 days, gastrointestinal bleeding within 30 days;
  * Laboratory: platelet count \<50,000, INR\> 2 or APTT\> 50s;
* Known or suspected adverse reaction to UFH, including heparin-induced thrombocytopenia (TIH);
* Adverse reaction or allergy to tocilizumab;
* Use of any of the following treatments: UFH to treat a thrombotic event within 12 hours before inclusion; HPBM in therapeutic dose within 12 hours before inclusion; warfarin (if used 7 days before and if INR greater than 2; thrombolytic therapy within 3 days before; and use of glycoprotein IIb / IIIa inhibitors within the previous 7 days;
* Pregnant or lactating;
* Absolute indication of anticoagulation due to atrial fibrillation or diagnosed thromboembolic event;
* Refusal by family members and / or patient;
* Active tuberculosis;
* Bacterial infection confirmed by culture;
* Neutropenia (\<1000 neutrophils / mm3);
* Use of another immunosuppressive therapy that is not a corticosteroid;
* Septic shock.
Gastroprotected Superoxide Dismutase in Combination With UVB vs Placebo and UVB for Treating Vitiligo.

The role of the oxidative stress in vitiligo is supported by many studies but robust data are lacking concerning their interest as therapeutic agents. The objective of the study is to compare the association of GLISODIN (a gastro-protected superoxide dismutase) and Nb-UVB to Nb-UVB and placebo for treating vitiligo.

Adult patients with non-segmental vitiligo affecting more than 5% of body surface area will be included.

The main criteria of evaluation will be the VES score at 6 months compared to baseline in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Vitiligo
* Vitiligo, SOD, UVB
* Non-segmental vitiligo with BSA\>5%

Exclusion Criteria:

* Criteria of non-inclusion

  * Segmental or mixed vitiligo
  * Pregnancy
  * Vitiligo lesions localized only on hands and feet
  * Immuno-suppressive drugs
  * Corticosteroids
  * Photosensitive drugs
  * Photodermatosis
  * Personal history of skin cancer
  * Allergy to gluten
Glucose/Insulin Responses:Subjects With Type 2 Diabetes Consuming Diabetes-Specific vs Standard Nutritional Formulas

To measure and compare the glycemic and insulinemic responses of subjects consuming a standard and two diabetes-specific products.


Eligibility Criteria:
Inclusion Criteria:

* signed and dated informed consent
* 18-75 years of age
* history of type 2 diabetes
* males and non-pregnant, non-lactating females

Exclusion Criteria:

* subject uses insulin for glucose control
* significant cardiovascular event \<12 weeks prior to study entry
* active malignancies
* history of end stage renal disease
* history of organ transplant
* current hepatic disease
* intervention for HIB
* takes niacin
* history of gastroparesis
* active disease that may interfere with nutrient intake
* allergy or intolerance to ingredients in the study products
Impact of Emotional Reactivity on Dysfunctional Decision-Making in NSSI Adolescents

Nonsuicidal self-injury (NSSI) is defined as direct, intentional physical injury without suicidal intention. Studies revealed that dysfunctional interpersonal relationships and reward-related decision-making may play crucial roles in this maladaptive behavior, especially in adolescents. These interpersonal decision contexts are characterized by constant updating of expectations of rewards and the actual received rewards as well as the associated emotional reactions. These processes have recently been computationally formalized as prediction errors (PE), specifically reward PEs, valence PEs, and arousal PEs (Heffner et al., 2021; Nat Hum Behav). In the current study, the investigators aim to investigate whether these PEs make discernible contributions to social decisions in the context of unfair experiences among adolescents with NSSI and matched healthy control adolescents (HC). Specifically the investigators hypothesized that: 1) reward and emotional PEs show significant predictions of punishment decisions in both groups, 2) however, compared to HC adolescents, the NSSI group will exhibit selective dysfunctions in emotional but not reward PEs leading to punish a norm proposer who provided unfair offers.


Eligibility Criteria:
Inclusion Criteria:

* 15-18 years
* right-handed
* normal or corrected normal visual acuity
* meet the proposed DSM-5 frequency criteria (e.g., ≥5 days of NSSI behaviors in the past year)

Exclusion Criteria:

* diagnosis of borderline personality disorder, major depressive disorder, other
* psychiatric disorders, etc.
* high suicidal risk
* recent use of medications that can affect neural activity
* have received or are receiving Dialectical Behavior Therapy (DBT) other treatment for emotional problems within the past 6 months
* have a contraindication to MRI scanning (e.g., metal implants, claustrophobia or other conditions that make them inappropriate for MRI scanning)
Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)

A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema

This is a multicenter, open-label, dose ranging study with 3 cohorts in the dose-escalation portion of the study and 1 cohort in the combination therapy portion of the study. An accelerated 3+3 design with parallel and sequential dosing will be used.

A total of 9 to 22 participants will be enrolled in the dose-escalation portion of the study to receive OCU200 alone (9 to 18 participants enrolled according to the 3+3 design and up to 4 participants replaced due to parallel cohort initiation). For the combination therapy cohort, a total of 3 to 6 participants will be enrolled to receive OCU200 (MTD) + Lucentis.

A total of up to 28 participants will be included in this study.

The DSMB will continue to review all available safety data two weeks post-dosing of participants.

Cohort 2 Medium Dose (1 mg/mL): 3+3 participants will receive intravitreal injection of OCU200 medium dose concentration. Following the same algorithm as Cohort 1.

Cohort 3 High Dose (2 mg/mL): 3+3 participants will receive intravitreal injection of OCU200 high dose concentration. Following the same algorithm as Cohort 2.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus
2. Decreased visual acuity attributable primarily to DME
3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of:

   1. ≥ 320 if male or ≥ 305 µm if female on Heidelberg Spectralis
   2. ≥ 305 if male or ≥ 290 if female on Zeiss Cirrus
   3. BCVA ≤ 78 and ≥ 24 letters on ETDRS chart
4. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging
5. No history of prior anti-VEGF injection for treatment of DME or history of at least 2 consecutive anti-VEGF intravitreal injection

Exclusion Criteria:

1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage)
2. Uncontrolled hypertension
3. Uncontrolled glaucoma
4. Concurrent disease in the study eye, other than central-involved DME
5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit
6. Any ocular surgery within 3 months prior to the screening visit in the study eye
7. Uncontrolled/poorly controlled diabetes
8. History of retinal detachment in the study eye or other retinal vascular disease in the study eye
9. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit
10. Presence of any inherited retinal disease or proliferative diabetic retinopathy
Medical Complications in Familial and Multifactorial Chylomicronaemia Syndromes

A retrospective, systematic study of reimbursed healthcare costs over a 10 year period in patients suffering from Familial Chylomicronaemia Syndromes (FCS) or Multifactorial Chylomicronaemia Syndromes (MCS) in order to establish the relative healthcare burden of both syndromes by linking the Hospices Civils de Lyon (HCL) registry of FCS or MCS patients and data obtained from FCS or MCS patients followed in Paris, Nantes and Lyon to the French National Health System (NHS) healthcare claims database, the Système National d'Information Inter-Régimes de l'Assurance Maladie (SNIIR-AM).

A probabilistic approach will be used to link databases. This linkage will be based on the following variables: age, gender, date of discharge of any hospitalization, date of any imaging procedure.

This study will help to describe, in real life, the management of severe hyperglyceridaemia in France. In addition, the descriptive results will help obtain a better understanding of the patients suffering from this disease, the burden of the disease and the healthcare consumption linked to this disease. Even if this consumption of care has been relatively unexplored until this point, it is not negligible. The potential of merging genomics and claims data for cardiovascular research could help to identify ways to optimize disease


Eligibility Criteria:
Inclusion Criteria:

* genetically documented FCS
* genetically documented MCS

Exclusion Criteria:

* None
A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Metformin

The objective of this study is to evaluate the pharmacokinetic interactions between ASP015K and metformin in healthy non-elderly male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Body weight at screening: ≥ 50.0 kg, \< 80.0 kg
* BMI at screening: ≥ 17.6, \< 26.4
* Subjects who agree to use highly effective contraception as consisting of two forms of birth control (at least one of which must be a barrier method) from getting informed consent through 90 days after the final study drug administration.
* Subjects who agree NOT to donate sperm from getting informed consent through 90 days after the final study drug administration.

Exclusion Criteria:

* Subjects who received or are scheduled to receive any investigational drugs in other clinical trials or post-marketing studies within 120 days before screening test or during the screening test to the hospital admission (Day -1).
* Subjects who received or is scheduled to receive any medications (including over-the-counter drugs) within seven days before the hospital admission (Day -1).
* Subjects who received ASP015K or metformin previously.
* Subjects who have a habit of excessive alcohol drinking or smoking.
* Any deviation from the normal range of blood pressure, pulse, body temperature, or 12-lead ECG at screening or on the day of hospital admission (Day -1).
* Subjects who meet any of the following criterion for laboratory tests at screening or on the day of hospital admission (Day -1). Normal ranges of each test specified at the study site or test/assay organization will be used as the normal ranges in this study.
* Subjects with a complication or history of drug allergies.
* Subjects who have a history of clinically serious allergy, which induces generalized urticaria or anaphylactic shock requiring hospital admission.
* Subjects with a complication or history of hepatic disease, renal disease, cardiac disease, congenital short QT syndrome, respiratory disease , gastrointestinal disease.
* Subjects with a history of gastrointestinal resection.
* Subjects who developed upper gastrointestinal symptoms within seven days before the hospital admission (Day -1).
* Subjects with a complication or history of endocrine disease, cerebrovascular disease, malignant tumor, lymphatic disease , lactic acidosis.
* Subjects who apply to any of the concerns with regard to tuberculosis.
* Subjects who apply to any of the concerns with regard to infection other than tuberculosis.
* Subjects with vaccination of live vaccines or live attenuated vaccines within 56 days before the hospital admission (Day -1).
Metacognitive Awareness, Pediatric Nursing, Students, Academic Achievement

* Metacognitive Awareness
* Pediatric Nursing
* Students Achievement

* The study was carried out at Faculty of Nursing Damanhour University Egypt. The Faculty of Nursing has nine different scientific nursing departments including pediatric nursing department. Pediatric nursing is one of the main courses was taught for the students enrolled in the third year in each term in the third scholastic year. Each term is consisting of 15 weeks. The clinical training (rotation) is given 12 hours /week.
* The present study subjects comprised of 150 students. The sample size was determined by using EPI Info 7 program using the following information: Population size = 500 (total no. of pediatric nursing students during the 2nd term of the academic year 2022 -2023), expected frequency =50%, acceptable error= 10%, confidence coefficient = 99%, which revealed a simple size = 125.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric nursing students
* Third year
* 19-23 years

Exclusion Criteria:

* None
Trial of Homeopathy on Management of Menorrhagia

The purpose of this study is to compare outcomes and quality-of-life issues in the treatment of menorrhagia, this randomized double blind controlled trial compared homeopathy and placebo. Clinical criteria were confirmed the diagnosis, and subjective assessment of the condition was performed during one pre-treatment and three treatment cycles. outcome measures were bleeding days, intensity. average pads used during menstrual cycle, abdominal \& back pain, General health and overall satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Age between 35-49 years with regular heavy menstrual bleeding
* menstrual loss requiring more than 5 Pads/tampons per day
* menstrual cycle longer than 6 days

Exclusion Criteria:

* Organic causes of menorrhagia
* History of renal or hepatic impairment,
* Endocrine disorder including diabetes, thyroidism
* Thromboembolic disease,
* Inflammatory bowel disease,
* Peptic or intestinal ulceration, or coagulation or fibrinolytic disorders and --Malignancy.
Evolution of Perceived Stress in General Practice Residents During COVID-19 Sanitary Crisis

Over the last several years, distress among healthcare professionals is well described, and general practice residents are also affected. Because of COVID-19 sanitary crisis, stress factors are increased, and that may cause anxiety, exhaustion, psychic distress, depression, addictions, or post traumatic stress.

This prospective non-interventional study aims to evaluate via two questionnaires the evolution of perceived stress in general practice residents of two centres in France, Rouen and Caen. The two questionnaires contain the Perceived Stress Scale, as well as items regarding socio-demographic data and stress factors. The first questionnaire is to be distributed during the epidemic COVID-19 wave and the second questionnaire at the end of the epidemic COVID-19 wave.

Eligibility Criteria:
Inclusion Criteria:

* Being a general practice resident in Rouen or Caen
* Participant informed and non-objection of him/her

Exclusion Criteria:

* Being on maternity leave or not working during the period concerned with the questionnaires
Interventions for Adolescent Obesity

This study will evaluate whether the short-term use of activity tracking devices improves short-term weight loss in adolescents. The investigators will evaluate whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. In addition, the investigators will report outcomes after the implementation of activity tracking devices in conjunction with an intense adolescent weight loss program.

This study will evaluate the short-term use of activity tracking devices and their effects on short- and long-term weight loss in adolescents. The investigators plan to establish whether weight loss translates into a change in obesity-related biomarkers associated with adolescent obesity. Each participant with an activity tracking device will have the goal of reaching 10,000 steps per day, in addition to their individual fitness plan.

Eligibility Criteria:
Inclusion Criteria:

Ages 12-18 years BMI ≥ 95th percentile for age and sex group Participant able to read and understand English Willingness to be randomized to any condition

Exclusion Criteria:

Inability to obtain informed parental consent and/or child assent Inability to participate in the program due to pre-existing conditions (e.g., paralysis, heart failure, severe autism or mental retardation, psychosis) Pregnancy Clinical judgment concerning safety Inability of the participant to speak English
Influence of Glucagon Inhibition in Relation to the Anti-Diabetic Effect of Glucagon-Like Peptide-1 (GLP-1) in Patients With Type 2 Diabetes Mellitus

Incretinbased treatment of patients with type 2 diabetes mellitus (T2DM) has increasing interest. The incretin glucagon-like peptide-1 (GLP-1) stimulates beta-cells to increased secretion and production of insulin. Glucose sensitivity is enhanced, apoptosis inhibited - progression in disease is potentially stopped. The alpha-cell is also influenced by GLP-1 as infusion lowers plasmaglucose (PG) levels in patients with type 1 diabetes mellitus (T1DM) (C-peptide negative) by inhibition of glucagon and thereby decreased hepatic glucoseproduction (HGP). Further Vilsboll et al has proved normalization of the glacgonostatic effect of glucose in patients with T2DM. As an attempt to elucidate glucose-intolerance in patients with T2DM further Knop et al investigated the glucagonresponse to both oral glucose tolerance test (OGTT) and a following iso-glycemic clamp. He saw a sufficient suppression of glucagon when glucose was introduced intravenously but the suppression of glucagon was attenuated and delayed when glucose was given orally.

The aim of this study is to elucidate the glucose intolerance further. Due to the complex interactions and mutual feed-back regulation between the pancreatic hormones and the PG level this protocol includes five days. All days include a euglycemic-clamp, patients with T2DM (n=10) are clamped at their fasting PG as are healthy control subjects (n=10). During the clamp either GLP-1 alone; GLP-1 in combination with somatostatin, insulin and glucagon; or somatostatin, insulin and glucagon are infused and blood samples are drawn.

The design of the study makes it possible to isolate the effect of each hormone. Further the investigators will be able to enlighten the effect of GLP-1 on the increase in glucose turn-over it induces.

The essential part in this design will be hormone concentrations and the response parameter the amount of glucose (AUC) it takes to create the euglycemic-clamp.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus according to criteria from WHO
* Normal hepatic and kidney function
* No overt diabetic complications
* Treatment with insulin or glitazones
* Informed consent

Exclusion Criteria:

* BMI \< 23
* BMI \> 35
* HbA1c \> 10%
* Pregnancy
Vancomycin Concentration in Cerebrospinal Fluid During Pneumococcal Meningitis

Adding vancomycin to the antibiotic regimen is recommended for the treatment of pneumococcal meningitis in adults. Use of dexamethasone as adjunct therapy has proved to reduce mortality and neurologic sequelae in adult patients with pneumococcal meningitis. However, use of dexamethasone may impair penetration of vancomycin in cerebrospinal fluid. In a purely observational manner, we thought to measure blood and CSF concentrations of vancomycin in adult patients with pneumococcal meningitis, treated with vancomycin, third-generation cephalosporin and dexamethasone.

Because of a considerable increase in streptococcus pneumoniae meningitis with penicillin nonsusceptible strains, it is now largely recommended to add vancomycin to the third-generation cephalosporin antibiotic regimen. It has also been recently shown that use of dexamethasone reduces mortality and unfavorable outcome in adults with pneumococcal meningitis. However, concern has arisen, that dexamethasone may impair penetration of vancomycin in cerebrospinal fluid.

We therefore thought to measure in a purely observational study, blood and CSF vancomycin concentrations in adult patients with pneumococcal meningitis hospitalized in medical intensive care unit that received third-generation cephalosporin, vancomycin and dexamethasone. The aim of the study was to observe whether or not sufficient concentrations of vancomycin could be measured in the CSF despite the concomitant use of dexamethasone. Patients were cared for in a perfectly routine manner. There was no randomization. All patients received routine, recommended care (IDSA guidelines). There was no invasive procedure. Dexamethasone was administered according to the de Gans study (NEJM 2002). In these patients with severe meningitis, a second lumbar puncture was performed as recommended(IDSA Guidelines, CID 2004). At the same time, peripheral blood was taken. In both samples, vancomycin concentration was determined.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 yr) with suspicion of pneumococcal meningitis requiring intensive care unit

Exclusion Criteria:

* Allergy to one of the antibiotics used in the study