cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Long-term Safety, and Efficacy of Brivaracetam (BRV) Used as Adjunctive Treatment in Subjects With Epilepsy

N01372 study is to evaluate the long-term safety, tolerability, maintenance of efficacy of Brivaracetam (BRV); as well as the effect of BRV on subjects' health-related quality of life and to explore the direct medical resource use for BRV (for subjects entering N01372 from a study where pharmacoeconomic data was collected). BRV will be used at doses up to maximum of 200 mg/day, as adjunctive treatment in subjects aged 16 years or older with Epilepsy.

Flexible dosing up to 200 mg/day, twice daily (10, 25 and 50 mg oral film-coated tablets). The study will continue until either regulatory approval of BRV has been granted by any Health Authority in an indication of adjunctive treatment of Epilepsy, or until the Sponsor decides to close the study, or until the BRV development is stopped by the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Subject is male or female and 16 years or older. Subjects under 18 years of age may be included only where legally permitted and ethically accepted
* Subjects having completed the Treatment Period of an applicable previous BRV study, and have access to the present study
* Subject for whom the investigator believes a reasonable benefit from the long-term administration of BRV may be expected
* Female subjects without childbearing potential (postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible. Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method
* Subjects must be able to take the oral film-coated tablets of BRV

Exclusion Criteria:

* Subject has developed hypersensitivity to any components of the Investigational Medicinal Product (IMP) or comparative drugs as stated in the protocol during the course of the prior study
* Severe medical, neurological, or psychiatric disorders, or laboratory values that may have an impact on the safety of the subject
* Poor compliance with the visit schedule or medication intake in the previous BRV study
* Planned participation in any other clinical study of another investigational drug or device during this study
* Pregnant or lactating woman
* Any medical condition which, in the investigator's opinion, warrants exclusion
* Subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either question 4 or question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at the last visit of the previous study or at the Entry Visit of this study if not completed at the last visit of the previous study
A Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and Seasonal Influenza Vaccine

This is a single blinded placebo controlled phase I study, to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with seasonal influenza vaccine. All volunteers recruited will be adults aged 50 and over.

The rationale behind co-administration of MVA-NP+M1 with a seasonal influenza vaccine (TIV) is that the immune system will be stimulated to produce both influenza specific T cells and influenza specific antibodies.


Eligibility Criteria:
Inclusion Criteria:

Men and women aged 50 or over with no upper age limit

* Resident in or near Oxford for the duration of the vaccination study
* Able and willing (in the Investigators' opinions) to comply with all study requirements
* Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
* For females who are not post-menopausal, a negative pregnancy test on the day of vaccination and agreement to practice effective contraception for the duration of the study
* Agreement to refrain from blood donation during the course of the study
* Written informed consent

Exclusion Criteria:

Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period

* Receipt of MVA or smallpox vaccines in the last 5 years, or receipt of the 2011/12 seasonal influenza vaccine prior to entering the study.
* Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
* Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled/topical steroids are allowed)
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
* Any history of anaphylaxis in reaction to vaccination
* Recent treatment for cancer (except basal cell carcinoma and cervical carcinoma in situ)
* History of serious psychiatric condition
* Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
* Seropositive for hepatitis B surface (HBsAg) or hepatitis C virus (antibodies to HCV)
* For pre-menopausal females, pregnancy, lactation or willingness/intention to become pregnant during the study
* Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study.
* No response / confirmation from GP regarding previous medical history
Real-time eCounselling for Nicotine Addiction

The goal of this clinical trial is to pilot an eHealth intervention (real-time telecounselling) in nicotine addiction. The main questions it aims to answer are:

Is the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase in nicotine consumption? Is the intervention likely to be efficacious in influencing Readiness to quit nicotine? How feasible is the intervention for developing a larger-scale trial?

Researchers will compare a range of outcome measures between the active and control arms, to see if a pilot eHealth intervention can successfully treat nicotine addiction.

The goal of this clinical trial is to pilot an eHealth intervention in nicotine addiction (real-time telecounselling) . It will also attempt to better understand the psychology of nicotine addiction and craving regarding consumption behaviour. The main questions it aims to answer are:

Is the intervention likely to be efficacious in preventing an increase in Abstinence? Is the intervention likely to be efficacious in preventing an increase in nicotine consumption? Is the intervention likely to be efficacious in influencing Readiness to quit nicotine? How feasible is the intervention for developing a larger-scale trial?

Researchers will compare outcomes pre and post intervention in the active arm, and also between active and control arms, to ascertain the treatment effect of the intervention on primary (nicotine consumption, abstinence) and secondary (self-efficacy, readiness to quit, decisional balance) measures, in tests of efficacy.

Following randomisation, participants will be allocated to either the active arm or the control arm. In the active arm, participants will undergo six weekly sessions of real-time CBT-MI (Cognitive Behavioural Therapy with Motivational Interviewing), with each session lasting approximately 45 to 60 minutes. In the control arm: A Wait List Control Group (WLCG) will denote the comparator, who will undergo screening and assessment only.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-65 Years old
2. Self Reported smoking ≥ 5 cigarettes per day, or regular vaper of \> 0mg nicotine
3. Desire to quit nicotine consumption
4. Willing to set a quit date
5. Able to provide written informed consent to participate -

Exclusion Criteria:

1. Enrolled in another behavioural intervention programme
2. Pregnant, breastfeeding or planning to become pregnant.
3. Individuals currently experiencing a problematic relationship with alcohol or drugs
4. Documented Cognitive Impairment
5. Individuals with a PHQ-9 score of ≥ 14 or a GAD-7 score of \>12.
Temperature Control in Central Fever in the Neuro-ICU

There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.


Eligibility Criteria:
Inclusion Criteria:

* Two or more days with core temperature ≥ 100.4F
* Approval of the patient's primary attending physician
* Need for core temperature measurement independent of the study.
* Admission to the Neuro-ICU \[intensive care unit\] for an underlying condition

Exclusion Criteria:

* Evidence for an infectious cause of fever, such as pneumonia, bacteremia, CNS \[central nervous system\] infection or urinary tract infection.
* Expected death from any cause
* Known sensitivity to the device
* History of pre-admission hypothalamic dysfunction or known temperature dysregulation
* Use of 2 or more vasopressor medications, since this may make a local skin reaction to the device more likely
* Hemodynamic instability
Use of Thermal Imaging Camera to Assess Perfusion Before and After Vascular Intervention

This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.

The main question this study aims to answer is:

- Are temperature measurements from a forward looking infrared (FLIR) camera of the lower extremity useful in predicting outcome of revascularization procedures?

This is a preliminary prospective observational study measuring change in lower extremity temperature in response to revascularization procedure.

Patients with lower extremity PAD will be seen in office pre-intervention. Consent to participate in the TIC study will be acquired at this point. Patients will be given a physical copy of their consent form at the time consent is obtained. During this initial visit or subsequent pre-procedural office visit, the smartphone-based thermal camera will be utilized to measure the temperature of the lower extremity foot, ankle, and leg at the plantar, dorsal, and lateral distributions. Comorbidities and demographic factors will be documented from medical records at this time as well.

Data will be gathered at a consistent location to minimize impact of room temperature on measurements.

Patients will then undergo scheduled revascularization with the interventionist.

Post-intervention pictures will be taken immediately after revascularization.

Patients will then be seen again by the research team for follow-up thermal camera imaging, 1 week post-intervention, and weekly post intervention for at least 1 month but up to 6 months.

Thermal measurements will be correlated with intra-op imaging and clinical outcomes in data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Lower extremity peripheral artery disease with tissue loss consistent with Rutherford classification V or VI.
* Planned lower extremity endovascular intervention

Exclusion Criteria:

* Non-arterial ulcers
* Pregnant
ABO-GLYC in Type 2 Diabetes

Evaluation of the improvement of the overall glycemic control after 6 months of treatment with ABO-GLYC, as a result of reduction of HbA1c and/or post-prandial glycemic peak.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients with diagnosis of type 2 diabetes, aged 18-75
2. HbA1c at screening between 6.5% and 7.5%
3. Last 2 HbA1c values in the last 12 months between 6.5% and 7.5%
4. Intolerance to metformin without unquestionable indication to other oral hypoglycemic agents
5. BMI 25-38 kg/m2
6. Willing and able to understand and sign the informed consent and complete the patient diary provided
7. Women participant of childbearing age should be negative to pregnancy test (performed on blood), and will have to use an appropriate contraceptive method throughout the study.

Exclusion Criteria:

1. Micro and macrovascular complication of diabetes in advanced stage (i.e., proliferative diabetic retinopathy; chronic renal failure III-IV stage KDOQI)
2. Chronic gastro-intestinal disease
3. Heavy smoker subjects
4. Alcohol abuse
5. Chronic liver and kidney disease (AST or ALT values \> 2.5 UNL or plasma creatinine \> 1.5 mg/dl)
6. Previous major gastrointestinal surgery
7. History of eating disorders
8. Pregnancy or lactation
9. Use of food supplements containing in particular but not limited to fibers and polysaccharides, in the last six months with frequency and dosage such as to interfere with the study.
10. Autoimmune diseases
11. Known hypersensitivity to any of the components of the product.
12. Any condition which prevent subject participation in the opinion of the principal investigator.
Nedaplatin in Treatment for Nasopharyngeal Carcinoma

To evaluate the efficacy of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma.

This is a prospective, phase II clinical trial to evaluate the efficacy and safety of induction chemotherapy with nedaplatin, docetaxel and 5-Fluorouracil followed by concurrent nedaplatin combined with radical radiotherapy in locally advanced nasopharyngeal carcinoma patients. This is a multicenter study. All patients will be enrolled in endemic area. All patients will receive radical intense modulate radiation therapy (IMRT). The primary endpoint is objective response rate (ORR).

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
* Original clinical staged as III-IVa (except T3-4N0) according to the 8th edition American Joint Committee on Cancer staging system
* No evidence of distant metastasis (M0)
* Age between 18-65
* WBC≥4×10\^9/ l, platelet ≥ 100×10\^9/ l and hemoglobin ≥ 90g/l
* With normal liver function test (TBIL、ALT、AST ≤ 2.5×uln)
* With normal renal function test (creatinine ≤ 1.5×uln or ccr ≥ 60ml/min)
* Satisfactory performance status: KARNOFSKY scale (KPS) \> 70
* Patients must give signed informed consent

Exclusion Criteria:

* Treatment with palliative intent
* The primary tumor or lymph node has undergone chemotherapy or surgery (except operations for diagnostic purposes)
* Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer
* History of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes
* History of previous radiotherapy
* Pregnancy or lactation
* Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, acute exacerbation of chronic obstructive pulmonary disease or other respiratory illness requiring admission to hospital, active hepatitis, and mental disturbance.
Erlotinib Intercalated With Chemotherapy Versus Erlotinib as First Line Treatment in Stage IIIB/IV NSCLC Patients With EGFR Mutation

This 2 arm study will compare the efficacy and safety of treatment with erlotinib intercalated with platinum-based therapy or erlotinib along, as first line treatment in Stage IIIB/IV Non-Small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation. Patients will be randomized to receive gemcitabine (1000mg/m2 iv) on days 1 , and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by erlotinib 150mg/day from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by erlotinib monotherapy, or erlotinib 150mg/day .The anticipated time on study treatment is until disease progression, and the target sample size is 60 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;advanced (stage IIIB/IV)non-small cell lung cancer;measurable disease;ECOG Performance Status 0-2.

Exclusion Criteria:

* prior exposure to agents directed at the HER axis;prior chemotherapy or systemic anti-tumor therapy after advanced disease;unstable systemic disease; any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix.
The Effect of Sleeve Gastrectomy on Food Preference

This is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered food preferences before and after surgery.

Participants that will undergo the sleeve gastrectomy surgery by Dr. Drake Bellanger's, will be asked to participant in a questionnaire survey. Once given the consent to participate, a food preference questionnaire (FPQ) will be administered at a pre-operative visit and then a six-week follow up visit at Dr. Drake Bellanger's office.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female, 18 years or over, who will undergo a sleeve gastrectomy for obesity by Dr. Drake Bellanger.

Exclusion Criteria:

* Women who are pregnant or nursing.
Medical and Economical Impact of IGRAs Diagnosis of Latent Tuberculosis in HIV-infected Patients

Tuberculosis is a current infection during HIV infection. After infectious contact, some patients will develop tuberculosis some will only be infected without symptoms, they have Latent Tuberculosis Infection (LTBI) which can reactivate later.In order to prevent this tuberculosis reactivation, LTBI diagnosis screening is preconised in HIV-infected patients. This diagnosis is made till now by the tuberculin skin test (TST) but this test is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific po MTB infection are now sold but have not been evaluated in immunocompromised HIV-infected patients.

The primary endpoint of this study is the evaluation of the theoretic therapeutic impact of the use of IGRAS for diagnosis of LTBI in HIV-infected patients

Principal outcome:

-Theoretic therapeutic impact evaluation of the use of IGRAS for diagnosis of LTBI in HIV-infected patients .

Secondary outcomes:

* Medico-economic impact of replacement of TST by IGRAs in LTBI screening in HIV infected patients.
* Concordance of IGRAs results with TST
* Concordance between IGRAs.
* Concordance between IGRAs in accordance to CD4 number(\< 100, 100 à 200, 200 à 300, \> à 300/mm3).
* LTBI prevalence in the study group.
* Effective consequences of tests results on therapeutic outcome of the patients LTBI criteria and therapeutic recommendations
* One or 2 positive IGRAs test: LTBI recommended to be LTBI
* 1 negative IGRAs test and one undetermined : no LTBI
* 2 undetermined:
* No clinical risk and negative TST: no diagnosis, eventually new test at 3 months or after HAART onset.
* Clinical risk or TST\> 10mm: LTBI recommended to be treated. Therapeutic outcome evaluation Effective consequences of IGRA's result on patients outcome at 6 months.

Analyzed criteria:

Therapeutic impact:

* Patients percentage with different therapeutic outcome based on usual recommendations
* Medico-economic impact
* Medico-economic impact of both tests as early and late cost - efficacy
* Statistics

Primary criteria:

* Percentage of patients for whom therapeutic would have been changed by IGRAs results compared to usual diagnosis strategy.

Secondary criteria:

* Concordance of IGRAs with TST
* Concordance between both IGRAs.
* Taille: 1000 patients

Timing:

-inclusions: 2 years

Eligibility Criteria:
Inclusion Criteria:

18 yrs old Confirmed HIV infection No HAART Consent signed 6 months follow-up possible

Exclusion Criteria:

Confirmed TB disease No social right pregnancy
Barley Tortillas Study in Healthy Volunteers

The variation in starch and fibre composition of prepared barley tortillas will have a significant effect on glycemic response.

Specifically, we wish to examine the glycemic response of barley tortillas containing different ratios of amylose and amylopectin and different amounts of soluble and insoluble fibre with an appropriate control during acute phase testing in healthy volunteers. Possible relationships between composition of the barley tortillas and the degree of physiological response will also be investigated as the secondary objective.

Eligibility Criteria:
Inclusion Criteria:

* male or female age 18 to 40 years
* normal glycated hemoglobin of \<6%
* BMI of 20 to 30
* must read the consent form
* must comply with the protocol requirements

Exclusion Criteria:

* allergies to barley flour
* presence of chronic conditions such as cardiovascular disease, hypertension, disorders affecting the gastrointestinal tract, thyroid disease, and requiring medication for these conditions
* requiring medication for glycemic control
* consumption of supplements which have an effect on blood glucose response
Efficacy of Electric 3D Versus Manual Toothbrushes in Patients With Fixed Orthodontic Appliances

This study evaluates if electric toothbrushes with a 3D action (rotation / oscillation and pulsation) are more effective than manual toothbrushes in removing plaque and reducing gingival inflammation in patients under orthodontic treatment with fixed appliances.

This trial is designed as a randomized, controlled, investigator blinded superiority trial, with two parallel groups and a 1:1 allocation ratio. Equal number of males and females will be allocated to each group.

One group of orthodontic patients will receive an electric toothbrush with orthodontic head and the other group will receive a manual orthodontic brush. Tooth brushing instructions will be provided. Measurements of two plaque indices and two gingival indices will be taken at baseline and at 3 monthly intervals.

Eligibility Criteria:
Inclusion Criteria:

- Age between 12 and 16 years. Good general health according to a recent full medical history. Fixed labial orthodontic appliances on all teeth from central incisor to first molar (bands on first molars, metallic brackets-conventional, not self ligating-on other teeth), in both the maxillary and the mandibular arch, placed at least two months before the patient is accepted into the study and no more than two years.

Non-extraction orthodontic treatment. Plaque-induced gingivitis: patients will be included if they have gingival bleeding on at least 30% of the sites examined using the criteria for bleeding of the Modified Simplified Gingival Index.

Exclusion Criteria:

- Active caries. Periodontitis. Tooth agenesis (excluding third molars). Syndromes and craniofacial deformities. Current use of electric toothbrush. More than two cervical and/or proximal fillings. Dental prostheses or dental implants. Smoking or use of other tobacco products. Antibiotics during the last 2 months. Medication that may result in gingival enlargement (e.g. anticonvulsants, immunosuppressants, calcium channel blockers).

Disabilities that might affect toothbrushing skills (manual dexterity, mental disabilities).

Peri-oral or intra-oral piercing. Cardiac or other medical condition that requires antibiotic prophylaxis for dental treatment.

Participation in other trials.