cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics and Adhesion of Lidocaine Topical System 1.8% With Water Exposure

The objectives of this study are to evaluate the adhesion performance and pharmacokinetics of ZTlido (lidocaine topical system) 1.8% during swimming, showering, and under normal conditions.

In this Phase 1, open-label, three-period crossover study, 24 healthy, adult male and female subjects are randomized to 1 of 3 treatment sequences. During each treatment period, subjects have one lidocaine topical system applied to their back for 12 hours with a 4-day washout between treatments. In each treatment period, the subject will either swim (Treatment A), shower (Treatment B), or refrain from these activities (Treatment C) while wearing the topical system. Blood samples for lidocaine PK will be collected pre-dose until 24 hours. Adhesion will be monitored throughout the wear time and skin irritation will be assessed the topical system is removed.

Eligibility Criteria:
Key Inclusion Criteria:

* Must be healthy based on medical history, laboratory work, and physical exam
* Body mass index ranging between 18.0-30.0 kg/m2, inclusive
* Capable of unaided swimming
* If childbearing potential, use of acceptable form of birth control
* In case of females of childbearing potential, have a negative serum pregnancy

Key Exclusion Criteria:

* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics or any component of the product formulation
* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness affecting the major body systems, including the skin
* Subjects with conditions that might affect application of the product or its adhesive properties (including psoriasis, eczema, atopic dermatitis, damaged or irritated epidermal layer, and excessive hair or oil on the skin)
* Use of antiarrhymthic drugs (such as tocainide and mexiletine) and local anesthetics within 14 days prior to product application.
* History of addiction, abuse, or misuse of any drug
* Use of nicotine-containing products within 30 days
A Study of JNJ-40411813 as Supplementary Treatment to an Antidepressant in Adults With Depression and Anxiety Symptoms

The purpose of this study is to evaluate the efficacy and overall safety and tolerability of treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety symptoms being treated with an antidepressant.

This is a multicenter, double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled study in adult patients with Major Depressive Disorder (MDD) with anxiety symptoms of relevant severity. The study will consist of 3 phases: a screening phase of up to 2 weeks, an 8-week double-blind treatment phase, and a 2-week post-treatment (follow up) phase. Patients will continue to take the same daily dose of their antidepressant (as directed by the investigator) at the same time of day, from screening through the end of the study, including the post-treatment phase. The total study duration for each patient will be approximately 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Disorder (MDD); patients with a diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or Panic Disorder may be included, if the investigator considers MDD to be the primary diagnosis
* A 17-item Hamilton Depression Rating Scale (HDRS17) total score =\>18
* A HDRS17 anxiety/somatization factor score =\>7
* Is receiving an antidepressant

Exclusion Criteria:

* Has other psychiatric condition, including, but not limited to, MDD with psychotic features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder, or schizophrenia
* Has a length of current Major Depressive Episode (MDE) \>6 months
* Has a current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
* Not including the inadequate response to the current antidepressant, has more than 1 failed antidepressant treatment of adequate dose and duration in the current MDE
Previous Injury History and Performance of Male Elite Ice Hockey Players

BACKGROUND: In ice hockey, skating is a combination of speed, power, and balance. OBJECTIVE:The aim of this study is to examine the relationship between previous injury history and on-ice and off-ice performance of elite male ice hockey players.

METHODS: This study was designed as prospective cross-sectional study. Fifty elite men's ice hokey players included (n=50, mean age 23y 8mo, SD 5y 3mo). Off-ice performance measures were 30 m Sprint Test, Broad Jump Test, Push-up Test, Hexagon Agility Test, Plank Test. The 2 on-ice tests were 30m On-ice Sprint Test and Cornering "S" Turn Agility Test.The athletes' history of injury were including previous injury site, type, number and the mechanism of injury. RESULTS: In push up test, there was a significant difference in those who had left hand and right knee injuries and, athletes who had dislocation were found to be statistically significant (p \<0.05). According to cornering s turn agility test results, athletes who had puck injury were found to be statistically significant (p \<0.05). In 30m sprint and hexagon agility test results, athletes who had overuse injury were found to be statistically significant (p \<0.05). There was a significant correlation between on-ice 30m sprint and cornering s turn agility tests with broad jump test and also with off-ice push-up and plank tests (p\<0.05). CONCLUSIONS: As a result of the performance tests, push up test might be a distinctive test in determining the performance of the athletes after injury. Also on-ice tests had a correlation with off-ice plank test which is the indicator of core muscle strength.

We believe that the current performance and performance deficiencies of the athletes determined and existing training programs will be arranged to eliminate performance deficiencies. We wanted to raise awareness about whether there is a general deficiency in ice hockey performance caused by past injuries and which exercises should be included in the training program in order to overcome performance deficiencies.

Eligibility Criteria:
Inclusion Criteria:

* Being a member of Turkish Ice Hockey Federation,
* To be subject to any of the licensed athletes who played in the super league team
* To be over 18,
* To be male.

Exclusion Criteria:

* Being under the age of 18,
* Being a woman,
* Having not suffered a musculoskeletal injury that would prevent him from going to training in the last 1 year or affect the outcome of the measurements.
Validation of RespiLife for Detection of Respiratory Suppression

The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.

The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for detection of respiratory rate and oxygen saturation in human subjects. This includes evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and oxygen saturation.

Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign the informed consent
* English speaking.
* Able to comply with visits and follow ups included in this protocol
* Ages 18-80 years

Exclusion Criteria:

* Mentally or cognitively incompetent persons who cannot understand the procedures or consent to the procedures.
* An unstable medical condition, acute of chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
* If a subject is not able to stop his CPAP or BiPAP therapy at least one week prior to the sleep study night. This will be determined ty the principal investigator based on her judgment.
* Skin rash on the forehead.
* A history of skin allergy to medical tape, even hypoallergenic tape.
* A history of skin cancer on the forehead.
Impact of the Lack of CMV-Specific CD8+ T Cell Response in CMV-Seropositive Donors in CMV Reactivation After Hematopoietic Stem Cells Transplant in CMV-Seropositive Recipients

Donor and recipient CMV-serostatus is one of the risk factor for CMV infection in solid organ transplantation. Recipients with IgG positive anti-CMV are classified as low-risk patients since it is considered that patients also have specific cellular immunity against CMV. However, investigators group has published that around 25% of solid organ transplant candidates lack CMV-specific CD8+ T-cell response ("humoral/cellular mismatch") and they are at a higher risk of CMV replication after transplantation. The main goal of this study is to analyze the impact of the humoral/cellular mismatch in hematopoietic stem cell transplantation (HSCT) CMV-seropositive donors on the CMV reactivation after HSCT in CMVseropositive recipients. Investigators will study not only the incidence of CMV reactivation but also the severity (duration and peak viral load), CMV disease and survival. CMV-seropositive patients who receive a HSCT (bone marrow or peripheral blood) from related donors will be consecutively recruited from Reina Sofía Hospital (Córdoba) and Marqués de Valdecilla Hospital (Santander).

Patients will be monitored during 12 months after HSCT. CMV-specific CD8+ T-cell response will be determined in their donors, using QuantiFERON-CMV assay, to know the frequency of humoral/cellular mismatch. Innate and adaptive immune reconstitution will be assessed by flow cytometry and experimental QuantiFERON Monitor assay. CMV-specific CD8+ T-cell reconstitution will be determined using QuantiFERON-CMV assay.


Eligibility Criteria:
Inclusion Criteria:

1. CMV Seropositive patients who receive a HSCT (Bone marrow or peripheral) blood from related donors
2. \>14 years old
3. signed Inform consent form

Exclusion Criteria:

1. HIV, HCV, HBV Infection
Cyclophosphamide Versus Mycophenolate Mofetil for the Treatment of Steroid-dependent Nephrotic Syndrome in Children

Idiopathic nephrotic syndrome is steroid-sensitive in more than 90% of cases in children. However 60% of cases are steroid dependent and required treatment with immunosuppressive agent. Cyclophosphamide and ciclosporin are used for long time to reduce steroid dependency, but duration of these treatments should be restricted because of gonadotoxicity for cyclophosphamide and nephrotoxicity for ciclosporin.

Mycophenolate mofetil appears as an alternative treatment without gonadotoxicity and nephrotoxicity. However, contrary to cyclophosphamide, mycophenolate mofetil does not seem to have a residual action so that treatment must be maintained during months or years.

The aim of the study is to compare efficacy of cyclophosphamide and mycophenolate mofetil in steroid dependent nephrotic syndrome in children.

Aim of the study: Comparison of efficacy of cyclophosphamide 148mg/kg in 12 weeks and mycophenolate mofetil 1200mg/m² during 18 months, in children with steroid dependent nephrotic syndrome.

The 70 patients will be recruited in the 26 centres of paediatric nephrology in France, included and randomized at the time of a relapse. They will receive the same steroid treatment in the 2 arms.

The primary point will be occurrence of a relapse during the 24 months of follow-up. Detection of relapse will be done by using dipsticks and confirm by biological dosages (albuminemia and proteinuria/CREATININURIA ratio). Clinical and biological check up will be done every 3 months during all the study.

Eligibility Criteria:
Inclusion Criteria:

* children 2 to 16 years old
* steroid dependency ≥30mg/m² eod
* or steroid dependency ≥15mg/m² eod and occurrence of : at least 2 relapses in 1 year, adverse event of steroid therapy (height rate ≤-1SD, obesity, other complication) or severe complication of nephrotic syndrome (thrombosis, collapse, severe infection,...)
* inform consent

Exclusion Criteria:

* steroid resistant nephrotic syndrome
* prior treatment with cyclophosphamide, mycophenolate mofetil or cyclosporine
* absence of contraception in pubescent girls
* allergy to cyclophosphamide or mycophenolate mofetil
* malignant disease
* treatment with other immunosuppressant treatment or with non-steroid anti-inflammatory or anti proteinuric medication (enzyme converse antagonist and angiotensin II receptor antagonist)
* absence of inform consent
* participation to other therapeutic trial
Monetary Cost of Alzheimer's Disease in China

The purpose of the study is to estimate the Chinese economic burden in patients with Alzheimer's Disease (AD).

This observational study covered all the 30 provincials/municipals/autonomous in mainland China except Hong Kong and Macau. Tier 3 hospitals, psychiatric hospitals, elderly hospitals, nursing home and communities were randomly selected as research centers, and more than 2500 patients with AD and their caregivers were enrolled at last. The main outcome of this study was assessed not only by the electronic medical system of communities and hospitals, but also by questionnaires. Using a societal prevalence-based gross COI approach to estimated the total yearly costs of AD in China.

Eligibility Criteria:
Inclusion Criteria:

1. New patients who are diagnosed with AD in this investigation or old patients who were diagnosed prior to this investigation were eligible；
2. AD diagnosis must meet criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and the National Institute of Neurologic and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA). The diagnosis should also meet the following: Modified Hachinski Ischemic Scale (MHIS) score≤4, Activity of Daily Living Scale (ADL) score≥23, Geriatric Depression Scale (GDS) score\<11. Neuroimaging MRI support AD diagnosis (exist atrophy in medial temporal lobe, white matter lesions score≤2 minutes according to the Fazekas criteria. AD disease classification according to mini-mental state examination (MMSE) scale (for illiterate dementia: mild: 21\~24 points; moderate: 11\~20 points; severe: 10 points or less; for lettered dementia: mild: 16\~19 points; moderate: 8\~15 points; severe: 7 points or less). The diagnosis of AD was confirmed by brain CT or MRI scans and by laboratory tests to rule out any other significant comorbidity.
3. 60-year-old and above, men or women.
4. Normal vision or corrected visual, normal audition or corrected auditory, and cooperate with inspections and treatments.
5. Consent to participate with a signed informed consent by himself/herself or guardians.

Exclusion Criteria:

1. Patient with vascular dementia or dementia caused by other reasons, such as major depression or other major psychiatric illnesses, thyroid dysfunction, encephalitis, multiple sclerosis, and other dementia which includes frontotemporal dementia (FTD), dementia with Lewy bodies (DLB), and Parkinson's dementia (PDD).
2. MRI and laboratory tests (blood cell counts, liver and renal function, electrolyte, vitamin B12/folic, HIV, syphilis, and so on) do not support or rule out AD diagnoses.
3. Has a history of alcoholism and drug abuse.
Systemic Amoxicillin Plus Metronidazole in Peri-implantitis Treatment

The primary objective of this controlled clinical trial is to evaluate the clinical effect of systemic amoxicillin plus metronidazole therapy in conjunction with initial non-surgical treatment of peri-implantitis. The secondary objective is to assess the microbiological effectiveness of this peri-implantitis treatment approach.

The present study is a single-blind, randomized controlled clinical trial. Adult patients with at least one endosseous implant in the oral cavity with clinical and radiographical evidence of periimplantitis will be included in this study.

Patients with implants affected by peri-implantitis will receive initial periodontal treatment existing of oral hygiene instructions and mechanical cleansing of both implants and remaining dentition. Immediately after initial periodontal therapy patients will be instructed to rinse their mouth with 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol twice daily during 30 seconds for 2 weeks. Additionally patients will receive a recipe for medication consisting of 500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for the following 7 days or no recipe.

The main study parameter is the mean peri-implant bleeding score.


Eligibility Criteria:
Inclusion Criteria:

* The patient is ≥ 18 years of age;
* The patient has at least one endosseous implant in the oral cavity with clinical and radiographical signs of peri-implantitis. Peri-implantitis is defined as a loss of marginal bone ≥ 2 mm as compared to the shoulder of the implant (the level at which the bone is normally located immediately after implant placement), in combination with bleeding and/or suppuration on probing and a peri-implant probing depth ≥ 5 mm;
* The implants have been in function for at least two years;
* The patient is capable of understanding and giving informed consent.

Exclusion Criteria:

* Medical and general contraindications for the surgical procedures;
* A history of local radiotherapy to the head and neck region;
* Pregnancy and lactation;
* Uncontrolled diabetes (HbA1c \< 7% or \< 53 mmol/mol)
* Mononucleosis infectiosa
* Organic neurological disorders
* Use of antibiotics during the last 3 months;
* Known allergy to amoxicillin, metronidazole or chlorhexidine;
* Long-term use of anti-inflammatory drugs;
* Full edentulism (no remaining teeth, only implants)
* Incapability of performing basal oral hygiene measures as a result of physical or mental disorders;
* Implants placed in areas augmented with autogenous bone from the crista iliac region;
* Implants placed in skin grafted areas;
* Implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond the transverse openings in hollow implants;
* Implant mobility;
* Implants at which no position can be identified where proper probing measurements can be performed;
* Previous surgical treatment of the peri-implantitis lesions;
* Previous non-surgical treatment of the peri-implantitis lesions during the last 6 months (scaling or curettage)
Pre- and Post-Operative Exercise Program in Upper Gastrointestinal Cancers

Esophageal and gastric cancers are a considerable health burden. In the past 10 years the 5-year survival for both cancers has doubled. This is due to a number of factors including advances in neo adjuvant and adjuvant chemotherapy and radiotherapy. However, physical fitness significantly declines as a result of neo adjuvant an adjuvant therapy. From studies in other cancers it is known that peri operative training improves physical fitness, yet there is little research into its effects in those with upper gastrointestinal cancers. The aim of this study is to assess the effect of a pre-and post operative training program on patients with upper gastrointestinal cancers on their physical fitness and consequently their optimism, quality of life and post operative morbidity.

The comparator in this study will be standard oncological care. There patients will receive the exact same care as the intervention group patients but will receive no exercise training program.

The primary goal of this multi-centre randomised controlled trial are to investigate the effects of peri-operative exercise training programmes on physical fitness, measured with a 6 minute walk test, in patients undergoing a major curative upper-GI resection for either oesophageal or gastric cancer.

The secondary aims will look at the effect of peri-operative exercise training on patients quality of life, optimism and well being, post operative morbidity, nutritional status and blood markers of inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years of age or above;
* Have confirmed Multi Disciplinary Team (MDT) evidence of adenocarcinoma or squamous cell cancer of the oesophagus, oesophago- gastric junction or stomach requiring neoadjuvant therapy and planned curative resection.
* Be referred by a multidisciplinary team meeting for neo adjuvant chemotherapy or neo adjuvant chemoradiotherapy prior to planned oesophagectomy or gastrectomy.
* Have measurement confirming (endoscopic or otherwise) that the tumour starts more than 5cm below cricopharyngeus;
* Be fit for pre-operative anaesthesia and surgery
* Be able to provide written informed consent.

Exclusion Criteria:

* Inability to participate in the exercise program (unable to perform 6 Minute Walk Test, unable to attend for assessment of parameters at any time point).
* Patients with high grade dysplasia (squamous cell or adenocarcinoma);
* Patients who have or develop metastatic disease at time of enrolment or during their neoadjuvant therapy;
* Patients being referred for primary surgery without requirement for neoadjuvant treatment;
* Patients with squamous cell cancer of the oesophagus who the MDT recommends or who individually elect to undergo definitive chemoradiotherapy;
* Evidence of previous/concomitant malignancy that would interfere with this treatment protocol;
* Pregnancy;
* Patients participating in other trials that would interfere with the implementation of this protocol at a particular site.
Study of Social Cognition Processes With Multimodal MRI on Healthy Adult Patients.

The study of higher cognitive functions (learning, memory, language, reasoning, decision making) in humans constitutes an interdisciplinary field, which combines neurobiological and neurological, neuropsychological, as well as linguistic and artificial intelligence skills. Historically, the study of patients with cerebrovascular lesions or brain pathologies associated with primary and/or cognitive deficits has produced fundamental knowledge in this area. The development of modern non-invasive investigation techniques of the human brain - such as Structural Magnetic Resonance Imaging (MRI), Diffusion Tensor Imaging, Functional Magnetic Resonance Imaging (fMRI), Positron emission (PET), the study of event-related electrophysiological potentials (ERP) or magneto-encephalography (MEG) - has made it possible to carry out similar studies on healthy subjects, as well as the in-vivo analysis of adaptive and plastic mechanisms of the human brain. Recently, the interest of cognitive neuroscience - this is the name taken by this vast interdisciplinary sector which aims to understand the neural mechanisms underlying human cognitive processes - has been oriented towards the study of decision making in social contexts. Knowledge of the mechanisms underlying these processes is fundamental for the most complete description of the biological bases of human behavior and above all for the optimal development of treatments for brain pathologies, whether surgical, pharmacological or rehabilitation in general.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 35 years old; Monolingual native speakers of Italian; Absence of neurological or psychiatric pathologies that could interfere with carrying out the exam.

Exclusion Criteria:

* Clinical and/or anamnestic evidence of significant neuropsychiatric or systemic pathologies; Previous head trauma with loss of consciousness