cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy pediatric subjects 6 months to 17 years of age,
2. Individuals' parent(s) or legal guardian(s) willing to provide written informed consent,
3. Individuals in good health,
4. Individuals/Individuals' parent(s)/legal guardian(s) willing to allow for serum samples to be stored beyond the study period,
5. Individuals willing to provide informed assent (where applicable).

Exclusion Criteria:

1. Individuals' parent(s)/legal guardian(s) not able to understand and follow study procedures,
2. History of any significant illness,
3. History of any chronic medical condition or progressive disease,
4. Presence of medically significant cancer,
5. Known or suspected impairment/alteration of immune function,
6. Presence of any progressive or severe neurologic disorder,
7. Presence of any bleeding disorders or conditions that prolongs bleeding time,
8. History of allergy to vaccine components,
9. Receipt of any other investigational product within 30 days prior to entry into the study,
10. History of previous H5N1 vaccination,
11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
12. Receipt of any other vaccine within 2 weeks prior to entry into the study,
13. Body temperature ≥38°C (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
14. Pregnant or breast feeding,
15. Females of childbearing potential refusing to use acceptable method of birth control,
16. Body mass index (BMI) ≥ 35 kg/m2,
17. History of drug or alcohol abuse,
18. Any planned surgery during study period,
19. Individuals conducting the study and their immediate family members,
20. Individuals with behavioral or cognitive impairment or psychiatric diseases,
21. Individuals diagnosed with any growth disorders.
Evaluation of Postoperative Radiotherapy and Concurrent Chemotherapy Effectiveness in Cervical Cancer

The present study is a randomized, control, phase II/III study of early stage (FIGO Ia2-IIb) cervical cancer after radical hysterectomy in Northwest China treated with radiotherapy or concurrent chemoradiotherapy based on the surgical-pathological risk factors. All the patients received whole pelvis radiation and were divided into three groups according to adjuvant chemotherapy: concurrent chemotherapy with cisplatin weekly (40mg/m2) , concurrent chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), or concurrent and adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2). The effectiveness, and side effects will be evaluated according to Standard WHO response criteria, and NCI common toxicity criteria for adverse events(NCI-CTC-AE) V3.0.

To the cervical cancer patient who accepted radical hysterectomy, whether the adjuvant therapy should be received or the method of adjuvant therapy are determined by the postoperative pathology. In the traditional opinion, the postoperative risk factors were divided into two groups: intermediate risk factors, including large tumor size, deep stromal invasion and lymphovascular space invasion, and high risk factors, including non-squamous cell carcinoma, marginal positive, parametric invasion and pelvic lymph node(LN) metastasis. Patients with intermediate risk factors should accepted adjuvant radiotherapy only and who with high risk factors should received adjuvant concurrent chemoradiotherapy. Cisplatin weekly(40mg/m2) was the standard regimen of concurrent chemotherapy. However, we retrospectively analyzed 801 cervical cancer patients with postoperative radiotherapy and found that distant metastasis was the main cause of current treatment failure(84.5%), which suggested the current regimen of chemotherapy was insufficient and might be strengthened in future.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years to 70 Years
* Histologically proven cervical cancer, FIGO stage Ia2-IIb,and no previous chemotherapy and radiotherapy
* Accepted radical hysterectomy 3-4 weeks before
* Karnofsky score \>70
* Postoperative pathology with following risk factors: Non-squamous cell carcinoma, deep stromal invasion, lymphovascular space invasion, marginal positive, parametria invasion, large tumor size (tumor diameter\>4cm) or pelvic LN metastasis. Patients with pelvic LN metastasis and combination of any two or more risk factors mentioned above were included.
* Examination results showed no radiation or chemotherapy contraindication
* Willing to accept treatment
* Ability to comply with trial requirements

Exclusion Criteria:

* Postoperative residual
* Postoperative recurrence or metastasis
* Without lymph node dissection
* Postoperative pathology showed aortic lymph node metastasis
* Examination results showed radiotherapy contraindications
* No indications for radiotherapy
Feasibility of Neostigmine for Intraoperative Neuromonitoring in Thyroid Surgery

For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with .

The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.

For successful intraoperative neuromonitoring (IONM), adequate reversal of neuromuscular blocking agent is a prerequisite in thyroid surgery with .

The aim of this study is to investigate the feasibility of neostigmine just after tracheal intubation on the IONM in thyroid surgery.

This study will be performed as a randomized controlled trial with two groups (N group: neostigmine group and NS group: normal saline group).

For the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation.

For the NS group, normal saline with a same volume of the N group will be administered just after tracheal intubation.

For all patients of two groups, investigators evaluate the quality of signal of IONM during the surgery.

Eligibility Criteria:
Inclusion Criteria:

* open thyroid surgery with intraoperative neuromonitoring

Exclusion Criteria:

* refusal to participate in the study
* rocuronium should not be used (e.g. renal dysfunction patient)
Quebec Lung Cancer Screening PLUS Trial

Does an educational intervention for untreated COPD and cardiovascular disease which is integrated in an existing lung cancer screening program improve guideline concordant medication adherence at 12 months


Eligibility Criteria:
Inclusion Criteria:

* Patient screened for lung cancer as part of the Quebec Lung Cancer Demonstration project by low dose CT scan of the chest.
* Cardiovascular aim: mild to severe CAC identified on low dose CT, not on guideline recommended lipid-lowering therapy.
* COPD aim: diagnosed with COPD, symptomatic (mMRC \>=1 or CAT\>= 10) and untreated, or not on first line guideline recommended therapy for COPD.

Exclusion Criteria:

* Any participant with a high suspicion of lung cancer, defined as Lung-RADS (Lung Imaging Reporting and Data System) 3 or 4, as this is an inopportune time to initiate new medical therapies.
* Cardiovascular aim: Absent CAC, known clinical atherosclerosis, known former heart surgery, Diabetes Mellitus.
* COPD aim: asymptomatic, or already on appropriate first line COPD therapy.
Assessment of Balance and Function After Lateral Ankle Ligament Repair

Approximately 85% of ankle injuries are lateral region injuries.Surgical repair of lateral ligaments is indicated if there is more than 20 degrees of varus or more than 15 mm translation, if conservative treatment is ineffective and degree of damage is high and chronic instability has developed.After the surgery in addition to pain and edema control, weight transfer is not performed on the ankle for 6 weeks.Therefore, this process may adversely affect the muscle strength and range of motion of the ankle, and lower extremity performance and muscular synergies of balance.Although pathological changes caused by ligament damage have been investigated very well in the literature, it is not clear how surgical repair affects these changes. In our study we aim to investigate post-surgical changes.

Primary aim of the study is to evaluate the balance parameters of individuals who have undergone anterior talofibular ligament and / or calcaneofibular ligament repair, and its secondary purpose is to evaluate lower extremity performance, ankle functionality, pain, range of motion and muscle strength and compare them with healthy individuals.

Our hypothesis is that the balance, lower extremity performance and functionality, pain, range of motion and muscle strength of patients who have undergone ankle lateral ligament repair are worse than healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have passed at least 1 year after the operation Unilateral arthroscopic ATFL repair Volunteer to participate in the study

Exclusion Criteria:

* Any orthopedic conditions, neuromuscular disease, balance disorder, cognitive disorder, history of fracture and surgical operation of the lower extremity
Clinical and Genetic Markers of Bone Metabolism in Children Under One Year

The study of children under one year of age for molecular genetic testing-VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) with the study of the frequency distribution of alleles and genotypes by polymorphisms, analysis of the relationship of molecular genetic markers with indicators of bone metabolism.

Children under the age of one year of Kazakh nationality born in Aktobe will be examined.

Each child included in the study will have an individual registration card, where information about the health status of the child and the health status of the mother during pregnancy will be filled in.

A biochemical analysis will be determined for the level of calcium, phosphorus, calcitonin, parathyroid hormone, osteocalcin, vitamin D in blood serum and deoxypyridinoline in urine.

Blood will be taken to determine the genetic polymorphism of VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759).

The state of bone tissue remodeling (osteocalcin, vitamin D, Ca, P, calcitonin, deoxypyridinoline) will be revealed The frequencies of allelic variants of the VDR (rs1544410, rs2228570), RANKL (rs9594738, rs9594759) genes in children under the age of one year in the population of Kazakhstan were determined.

Eligibility Criteria:
Inclusion Criteria:

-Children 0 -12 months old

Exclusion Criteria:

* Musculoskeletal system diseases;
* Severe chronic somatic diseases;
* Supplementation of vitamin D in a therapeutic dose;
* Lack of consent of the parents or legal representatives to participate in the study.
Objective Testing of Tear Film Stability

The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when cared with two different multi-purpose solutions over a two week wearing period.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must be at least 18 years of age and no more than 80 years of age.
2. The subject must have a best corrected visual acuity of 20/30 or better for each eye.
3. The subject must habitually wear contact lenses.
4. The subject must have had an eye exam within the last 12 months. The exam data must be available to the investigators prior to the first visit.
5. The subject must have normal eyes, no use of ocular medications, no ocular infection of any type, and no ocular inflammation.
6. The subject must read understand and sign the Statement of Informed Consent.
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

Exclusion Criteria:

1. Ocular or systemic allergies or disease that might interfere with contact lens wear.
2. Systemic disease, autoimmune disease or use of medication which might interfere with contact lens wear.
3. Clinically significant (FDA Scale grade 3 or 4) corneal edema, corneal vascularization, corneal staining or any other abnormalities of the cornea which would contraindicate contact lens wear.
4. Clinically significant (FDA Scale grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
5. Any ocular infection.
6. Pregnancy or lactation.
7. Diabetes
8. Infectious diseases (e.g. hepatitis, tuberculosis)
9. Contagious immunosuppressive diseases (e.g. HIV)
Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)

This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus

Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are numerous and include topical and systemic agents. Steroids were found effective in management of OLP with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. Pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. The recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of OLP decreasing pain and discomfort associated with this chronic condition.The aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (OLP).

Eligibility Criteria:
Inclusion Criteria:

* The study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type OLP and signed the informed consent

Exclusion Criteria:

* Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate
Observance of Preoperative Fasting Time a Before-and-after Sensitization Campaign to Fasting Guidelines Study

The goal of this before and after observational study is to evaluate the impact of a global sensitization campaign (targeted on surgeons, anesthetist and patients) about pre-operative fasting in an adult population. The main questions it aims to answer are:

* Does the sensitization campaign reduce fasting time?
* Does reduce fasting time increase quality of post-operative recovery?

Sensitization campaign will be performed between the before and after phases, it will include:

* Planned and repeated mandatory on site lecture about pre-operative guidelines for surgeons, anesthetists and paramedics.
* Reminder display in surgical wards and consults.
* Individualized fasting cards for patients.
* Short message service reminder on pre-operative fasting rules for patients.
* Medical fasting prescription with clear fasting times.


Eligibility Criteria:
Inclusion Criteria:

- Adult undergoing a surgical procedure.

Exclusion Criteria:

* Already intubated patient before surgery.
* Redo surgery during the same hospitalization
* Medical indication of fasting (e.g : occlusive syndrome)
* Patient unable to anwser the questionnaire.
* Patient under lawful protection
* Pregnant women
* Minor (\<18 years)
Bipolar Disorder and Oxidative Stress Injury Mechanism - Clinical Big Data Analysis Based on Machine Learning

This study is a single-center, retrospective, cross-sectional study. We plan to work with our network information center to analysis the related indicators of oxidative stress injury in patients with bipolar disorder based on oxidative stress data. During the study, machine learning was used as a data analysis method to screen out the biomarker risk factors with sensitivity and specificity for early recognition of bipolar disorder from major depression disorder with oxidative stress injury as the core. And then build up effective clinical predictive models for early identification of bipolar disorder, which can predict the early quantitative probabilistic of the onset of bipolar disorder.


Eligibility Criteria:
Inclusion Criteria:

* age is not limited
* gender is not limited
* meets the diagnostic criteria for bipolar disorder of ICD-10 F31,F32 and its sub-categories
* has relevant HIS system data that can be utilized.

Exclusion Criteria:

* patients who did not meet the appeal diagnosis after three-level rounds of ward
* patients who met the above three diagnoses but had severe data loss (missing value ≥ estimated data value of 30%)
Prednisolone in Infantile Spasms- High Dose Versus Usual Dose

Infantile spasms comprise a difficult to treat type of epilepsy in young children. Hormonal treatment, i.e. Prednisolone and ACTH are considered the treatment of choice. There is no consensus on the dosage of Prednisolone required for the treatment of infantile spasms. Recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual dose (2 mg/kg/day). However, there are no randomized controlled trials comparing these doses. A higher steroid dose may also be associated with more side effects. Therefore, this study was planned to compare the efficacy and tolerability of the high dose versus the usual dose in children with infantile spasms, in a randomized open-label trial design


Eligibility Criteria:
Inclusion Criteria:

- Children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with EEG evidence of hypsarrhythmia or its variants

Exclusion Criteria:

1. Children with active systemic illness
2. Children with evidence of active tuberculosis
3. Severe Acute Malnutrition ad defined by WHO (visible wasting/Mid Upper Arm Circumference \< 11 cm/pedal edema/Weight for height \< 3 SD)
4. Children with recurrent illness/chronic systemic illness
Effects Zulresso on Postpartum Psychosis

This is an open-label, proof of concept trial to investigate the efficacy, safety and tolerability of Zulresso (brexanolone) administered to adult female subjects diagnosed with postpartum psychosis. This study will provide critical pilot data to determine whether there is similar treatment efficacy among patients with postpartum psychosis as observed to date in patients with postpartum depression.

This is a single site, open label study design to evaluate the efficacy, safety and tolerability of Zulresso in female subjects diagnosed with postpartum psychosis.

Participants will be consented, and if possible, participation will be discussed with available family members. Participants will take a consent questionnaire prior to consenting to ensure the voluntary nature and understanding of study procedures. Participants will undergo a screening visit including diagnostic interviews, clinical laboratory assessments and an EKG to determine eligibility. If eligible, participants will be admitted in-patient to UNC Hospitals and administered a continuous 60-hour infusion of Zulresso using the approved FDA REMS protocol for postpartum depression. A target dose of 90 μg/kg/hour will be administered over a period of 2.5 days following a strict tapering schedule. Monitoring will occur for an additional 12 hours after the infusion. The subject will participate in 6 follow up visits at day 7 post-infusion, day 14, day 21, day 30, day 60 and day 90.

Eligibility Criteria:
Inclusion Criteria:

* All participating subjects sign an informed consent form;
* Age 18-45 years old;
* Onset of affective psychosis or mania symptoms in the 3rd trimester, within 4 weeks of delivery, or within 4 weeks of weaning;
* Clinician diagnosis of affective psychosis or mania;
* ≤12 months postpartum at screening

Exclusion Criteria:

* Positive pregnancy test at screening or day 1;
* Recent pregnancy did not result in a live birth;
* Subject is in renal failure;
* Subject is in hepatic failure;
* Subject is anemic (hemoglobin ≤10 g/dL);
* Untreated or inadequately treated hypothyroidism or hyperthyroidism;
* History of schizophrenia, and/or schizoaffective disorder;
* Current/active alcohol or drug abuse
Immune Modulation Study in Patients With Metastatic Melanoma Treated With Anti-PD1 Monoclonal Antibodies

This is an open mono-centric prospective non-randomized study in patients with metastatic melanoma treated with Anti-PD1 monoclonal antibodies (Nivolumab). The aim of the study is to identify the immune cells modulations differences between patients who present a complete, partial or stable response and patients who have non-response to the therapy in order to establish an improving response rate strategy.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 18 years
* Patient with metastatic or unresectable melanoma
* Anti-PD1 monoclonal antibodies treatment indication
* Patient affiliated to a social security regime
* Signed Written Informed Consent.
* agree with the storage of his biological samples
* Women of childbearing potential must as mentioned in the summary of product characteristics (SPC) using two effective methods of contraception during treatment, and men whose partner is of childbearing potential must use effective contraception during treatment. For all patients treated men and women, contraception should be continued during the four months following the discontinuation of nivolumab.

Exclusion Criteria:

* development of haematological tumor during treatment
* Patients requiring concomitant chronic treatment with systemic corticosteroids or other immunosuppressive agents
* Patients with autoimmune disease.
* Patient with Occular melanoma
Sphenopalatine Ganglion Block for Headache After Concussion

This clinical trial will enroll participants to evaluate the effects of SPG block on post-traumatic headache. The study hypothesizes that patients that receive a SPG block with lidocaine vs. placebo (saline) will have a lower number of headache days in the week following the procedure, and will also report lower symptom scores.

Eligible participants will receive one treatment (SPG block) as well as complete surveys prior to and after receiving treatment (for a total of approximately 2 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a concussion and are greater than 14 days from the date of their injury.
* Experiencing greater or equal than 4 occurrences of headache per week lasting at least 1 hour per occurrence with a headache severity score greater or equal to 2 out of 6.

Exclusion Criteria:

* Allergy to local anesthetics of the amide type (for example (i.e.) lidocaine)
* Frequent epistaxis (i.e. more than one nose bleed per month),
* Bleeding disorders
* History of any of the following: nasal or facial fracture, nasal septal defect, any other craniofacial abnormality, hepatic disease, Adam-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe degrees of sinoatrial, atrioventricular, or intraventricular heart block
* Pregnant
* Are at increased risk for methemoglobinemia (including patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, and concurrent exposure to oxidizing agents or their metabolites and drugs associated with methemoglobinemia)