cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Salivary Gal-7, Gal-10 and MMP-9 Levels of Individuals With Different Periodontal Diseases

The aim of this study is; detection of Galectin-10, Galectin-7, MMP-9 levels in saliva samples of periodontally healthy, gingivitis and periodontitis patients and the possible correlation between these values and clinical parameters of periodontal diseases. Materials and methods: Samples of saliva were obtained from 60 systemically healthy non-smoker individuals with periodontitis (P, n=20), gingivitis(G, n=20) and healthy periodontium (S, n=20). Full-mouth clinical periodontal measurements including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were also recorded. Enzyme-linked immunosorbent assay (ELISA) was used to determine Galectin-10, Galectin-7 and MMP-9 levels in the biological samples.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy (The determination of healthy volunteers will be based on the statements of the patients in the anamnesis. No additional examinations will be made.)
* At least twenty permanent teeth in the mouth
* Non-smoker
* No medication for continuous use
* Those who have not used antibiotics, anti-inflammatory and systemic corticosteroid drugs in the last 6 months.
* Not in pregnancy or lactation period.
* For the periodontitis group that has not received periodontal treatment in the last 6 months
* For the periodontitis group; According to the evaluation made in 6 regions of each tooth, individuals with 30% or more bleeding on probing area, at least 2 teeth not adjacent to each quarter jaw with a depth of 5 mm or more and 4 mm or more attachment loss, coronal 1/3 and more on radiography (horizontal and / or vertical) bone loss
* For the gingivitis group; According to the evaluation made in 6 regions of each tooth, individuals with 10% or more bleeding on probing area, having a probing depth of less than 4mm and no attachment loss
* For healthy group; According to the evaluation made in 6 regions of each tooth,individuals with less than 10% bleeding on probing area, having a probing depth less than 4mm and no loss of attachment were included in the study.

Exclusion Criteria:

* Any oral or systemic disease
* Regularly using a systemic medication
* During pregnancy or lactation
* Received periodontal treatment within the last 6 months.
* Those who received antibiotic, anti-inflammatory or systemic corticosteroid medication in the last 6 months
* Smokers are not included in the study
Kaiser Permanente HIV Cohort Study

Human Immunodeficiency Virus (HIV) infected patients in the Kaiser Permanente HIV registry wil be followed in the usual clinical care to estimate the rates of specified clinical events. The rates will be stratified by relevant characteristics like age, CD4 counts, HIV Viral Load (VL), HIV medication history. The rates in the HIV infected cohort wil be compared with the rates of these events in patients in the Kaiser Permanente database who are not infected with HIV.

All HIV infected patients in the database will be included without any sampling. A random sample of non-HIV infected patients will be included as comparator.

Eligibility Criteria:
Inclusion Criteria:

HIV infection.

Exclusion Criteria:

None
Children's Bilateral Cochlear Implantation in Finland

The purpose of this study is to evaluate short and long term outcomes (benefits and side-effects) of bilateral cochlear implantation and bilateral hearing aid rehabilitation in Finnish children.


Eligibility Criteria:
Inclusion Criteria:

* Congenital severe or profound bilateral hearing impairment
* No functional benefit from conventional hearing aids (minimum 3 months trial)
* Radiologically (CT,MRI) patent inner ears and normal central auditory pathways
* Family is motivated for rehabilitation programme and gives a written consent
* Finnish or Swedish as the primary language in the home

Exclusion Criteria:

* A child has an additional anomaly or disability that may affect to his/her functional or neurological development
* Inner ear anomaly
* Mother's pregnancy duration less than 32 weeks
Biometric Recognition and Rehabilitation Assessment of Lower Extremity Sports Injury Based on Gait Touch Information

The current common clinical methods cannot truly reflect the biomechanical status of the knee joint. Based on the foot-knee coupling mechanism, the simple and practical dynamic gait touch information provided by the 3D force platform are closely related to the knee biomechanics. The purpose of this study is to investigate the disease feature recognition, computer-aided diagnosis and rehabilitation assessment based on the gait touch information related to lower limb injuries.

Background:

The current common clinical methods cannot truly reflect the biomechanical status of the knee joint. The three-dimensional gait analysis is the gold standard, but it is difficult to apply clinically. There is an urgent need for a clinically practical method to quantitatively evaluate the biomechanics of the knee joint under dynamic weight bearing.

Methods:

50 healthy volunteers, 450 sports injuries patients (including hip, knee, and ankle joint diseases) and 50 patients with degenerative osteoarthritis were recruited.

55 passive reflective markers were placed bilaterally on the body. Lower extremity kinematics and dynamic plantar pressure during walking, jogging were collected.

Outcome evaluation indicators and statistical methods: The following indicators use repeated measurement two-factor analysis of variance: the left and right sides, different rehabilitation times are used as repeated measurement variables, to analyze the biomechanical changes of the lower limb joint biomechanics and gait touch information. A variety of machine learning methods (such as PCA, SVM, CNN, etc.) are used to analyze, and select the appropriate algorithm and parameters according to the learning effect. Finally, this study will establish a machine learning models for computer-aided diagnosis, treatment, and rehabilitation assessment.

Eligibility Criteria:
Inclusion Criteria:

* patients with a certain sports injury (soft tissue injury or degenerative osteoarthritis) of a joint of the lower limb (hip or knee or ankle or foot).

Exclusion Criteria:

* Cognitive impairment
* other injuries affecting movement performance.
A Study to Investigate ANS03 in Participants With Locally Advanced or Metastatic Solid Tumors

This is a first-in-human Phase I, multi-center, open-label study of ANS03 in patients with advanced solid tumors. The study evaluates the safety, tolerability, preliminary efficay, pharmacokinetics, anti-tumor activity of ANS03 as monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
* Life expectancy ≥ 12 weeks
* Measurable disease per RECIST v1.1
* Adequate organ and marrow function as defined in the protocol
* With documentation of ROS1 or NTRK alteration

Exclusion Criteria:

* Active infection including tuberculosis and HBV, HCV or HIV
* Known active or untreated CNS metastases
* Participants with carcinomatous meningitis or meningeal metastases, or spinal cord compression
* Participants with serious cardiovascular or cerebrovascular diseases
Distribution of Tacrolimus in Skin, Atopic Dermatitis

This study was designed to further increase the understanding of the pharmacokinetics of tacrolimus in the affected skin of atopic dermatitis patients following repeated topical application of tacrolimus ointment 0.1%.

The study was conducted on an out-patient basis, with patients self-administering the ointment twice daily at home. However, on Days 1 and 14 there was only a single application of ointment and this was applied by the Investigator or his/her designee in the clinic. An area of the affected skin was selected for skin biopsy of sufficient size for 5 biopsy samples. The biopsy samples were taken from the same lesion(s) if possible or from an adjacent lesion in the same anatomical area at all times. All areas selected for treatment were treated with tacrolimus ointment 0.1% for a period of two weeks with a follow up period of one week. Two pharmacokinetic profiles (Days 1 and 14) and five skin biopsy samples (Days 1, 2, 15, 18 and 21) were taken.

Eligibility Criteria:
Inclusion Criteria:

* Using the Hanifin and Rajka Criteria, the patient has a diagnosis of moderate to severe atopic dermatitis
* Using the Rajka and Langeland grading system, the patient's atopic dermatitis score is at least 4.5 (moderate to severe)

Exclusion Criteria:

* Patient has a serious skin disorder other than atopic dermatitis.
* Patient has history of eczema herpeticum (defined as an acute disseminated cutaneous herpes simplex type 1 or 2 infection associated with constitutional symptoms like fever, headache, malaise, regional or generalised lymphadenopathy in an individual with eczema).
A Pharmacokinetics Study of MultiHance in Pediatric Patients

Compare relative exposure in the younger age group in order to supplement the PK profile already determined in older children and adults


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 2 and 5 years of age
* Obtained informed consent from patient's parent or guardian
* Obtain assent when applicable according to local law
* Known or suspected disease of the central nervous system (brain or spine)
* Referred for MRI of the brain or spine requiring an injection of an MR contrast agent

Exclusion Criteria:

* Contraindications to MR examination
* Undergoing MRI in an emergency situation
* Known allergy to one or more ingredients in the contrast agent or history of hypersensitivity to gadolinium or metals
* Sickle cell anemia
* Likely to undergo an invasive examination within 72 hours after administration of the investigational product
Cardioneuroablation for the Treatment of Vagally-mediated Atrial Fibrillation.

Pulmonary vein isolation (PVI) is a cornerstone for catheter ablation of atrial fibrillation (AF), however, exact mechanisms of PVI efficacy remain debatable. It has been postulated that in patients with increased vagal tone AF can be treated by attenuation of parasympathetic drive to the heart using cardioneuroablation (CNA) by means of radiofrequency (RF) of the ganglionated plexi, however, data in literature and guidelines are lacking. The objective of this study is to examine the mid-term efficacy of RF-CNA targeting the right anterior ganglionated plexus (RAGP) in management of AF using right-atrial approach only.

Calculation of deceleration capacity (DC) was derived from the result of 1-minute monitoring of R-R intervals recorded using electrophysiology (EP) system.

Double access to the right femoral vein was obtained under ultrasound guidance. Four- or ten-pole diagnostic electrode was introduced into the coronary sinus and an open-irrigated or 8 mm ablation catheter (AC) was advanced into the superior vena cava. The location of RAGP was determined purely anatomically at the sites of fragmented potentials below the superior vena cava ostium and the superior-septal aspect of the right atrium in the left anterior oblique (LAO) view and was guided fluoroscopically. RF applications were delivered and were continued until heart rate (HR) acceleration \>30% was achieved or RF time exceeded 120 s.

Clinical follow-up (FU) consisted of multiple ambulatory visits with standard ECG and a 7-day Holter during the FU period. During FU visits, a detailed history of any palpitations, episodes of AF, and hospitalizations for cardiac arrhythmias was collected.

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal atrial fibrillation
* Deceleration capacity \>7ms

Exclusion Criteria:

* Permanent AF lasting more than one year or persistent AF lasting more than 7 days
* AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes
* Anteroposterior dimension of the left atrium in the echocardiography ≥ 5.5 cm
* Significant valvular disease
* Prosthetic valve
* Heart failure New York Heart Association (NYHA) class III/IV
* Previous AF ablation
* History of a persistent oval opening/atrial septal defect closure
* History of left atrial appendage closure
* Atrial myxoma
* Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device
* Symptomatic hypotension
* History of pericarditis
* Congenital heart disease
* History of coagulation disorders
* Contraindications to oral anticoagulation
* Contraindications to computed tomography or magnetic resonance imaging
* History of transplantation
* Severe lung disease
* Chronic renal failure defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/m2
* Cancer
* Significant infection
* Life expectancy less than one year
* Lack of informed consent to participate in the trial
* Participation in another trial
A Study of NeoRecormon (Epoetin Beta) in Anemic Patients With Chronic Hepatitis C.

This single arm study will assess the safety of NeoRecormon in the correction of anemia in patients with chronic hepatitis C who are being treated with Pegylated interferon + ribavirin combination therapy. Patients will receive NeoRecormon at a starting dose of 30,000 IU s.c. which will be adjusted as required to maintain a target Hb of 11-13g/dL. The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic hepatitis C;
* quantifiable serum HCV RNA;
* Pegylated interferon + ribavirin treatment started \<6 months before study;
* Hb \<10g/dL.

Exclusion Criteria:

* treatment with ESA during preceding 12 weeks;
* poorly controlled hypertension;
* history of cancer, except for basal cell cancer and cervical cancer in situ.
Study of ChimeriVax™-Japanese Encephalitis Vaccine in Toddlers in Thailand and the Philippines

This study is to assess the safety and immunogenicity of three consecutive lots of JE-CV in toddlers aged 12-18 months.

Primary objective:

To demonstrate the bio-equivalence of three lots of JE-CV vaccine manufactured by sanofi pasteur.

Secondary objective:

To describe the safety of vaccination in all subjects

This is a Phase III trial in toddlers in Thailand and the Philippines.

Eligibility Criteria:
Inclusion Criteria :

* Aged 12 to 18 months on the day of inclusion.
* In good general health, without significant medical history.
* Provision of informed consent form signed by at least one parent or other legally acceptable representative, and by at least one independent witness if required by local regulations.
* Subject and parent/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
* Completion of vaccinations according to the national immunization schedule.

Exclusion Criteria :

* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing any of the same substances.
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
* Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of the immune response.
* Administration of any anti-viral within 2 months preceding V01.
* History of central nervous system disorder or disease, including seizures.
* Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
* Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
* Planned receipt of any vaccine in the 4 weeks following any trial vaccination.
* Personal human immunodeficiency virus seropositivity in the blood sample taken at screening.
* Receipt of any JE vaccine or hepatitis A vaccine.
* Previous vaccination against flavivirus disease.
* History of flavivirus infection (confirmed either clinically, serologically or microbiologically)
* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
* Febrile illness (temperature ≥38°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment.
Active Video Game on Metabolic, Cardiovascular, and Psychological Metrics in Older Adults

The Xbox Kinect seems to be a good alternative for the older adults to perform physical activities at times that are typically associated with sedentary behaviors. The Xbox Kinect active video game has been used in various parts of the world as entertainment. The study of metabolic, cardiovascular and psychological responses during these activities may bring relevant information regarding the intensity of the exercises and, consequently, about the possibility of using these games to maintain and / or improve the cardiorespiratory fitness of the older adults. In addition, the present study may clarify the responses of activities on Xbox Kinect in elderly people with anxiety and depression symptoms. Will be selected 100 older adults. All volunteers will initially perform assessments of resting metabolic rate, cardiorespiratory fitness, functional tests, as well as subjective assessments of physical activity level, anxiety and mood. Subsequently, they will perform activities with body movements on the Xbox Kinect, which will be compared with sedentary behavior activity (TV / Movie). All activities will be monitored by means of a gas analyzer, which will record information about the behavior of energy expenditure, resting heart rate and activity. In addition, assessments of perception of effort and fun during activities will be made through subjective scales. The effects of Xbox Kinect activity on anxiety symptoms and mood will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* age \> 60 years
* Mini-mental score ≥ 24
* non-smoker
* no beta-blockers
* no cardiovascular risk
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 years.
* Documented congenital fibrinogen deficiency (afibrinogenemia).

Exclusion Criteria:

* Life expectancy \> 6 month.
* Bleeding disorder other than congenital fibrinogen deficiency.
* Presence or history of hypersensitivity to study medication.
* Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment.
* Presence or history of arterial thrombosis with 1 year prior to enrollment.
* Hypersensitivity to human plasma products.
* Acute bleeding.
* Pregnant or currently breast-feeding women.
* Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery (if available).
* Blood or plasma donation in the 3 months prior to enrollment.
* Human immunodeficiency virus (HIV) positive with a viral load \> 200 particles/µl or \> 400000 copies/mL.
* End-stage liver disease.
* History of oesophageal varicose bleeding.
Use of Aromatherapy in Conjunction With Physical/Occupational Therapy in an Acute Care Setting

Use of inhaled essential oils to reduce the symptoms of pain or nausea, enabling a patient to have increase participation with PT or OT, thereby minimizing hospitalization-related risks and potentially reducing the length of stay in the hospital.

The study intervention consists of 3 essential oils: lavender, mandarin and peppermint administered on an inhalation patch affixed in the chest region of the participant gown. The inhalation patch consists of hydrogel cast onto polyester film, supported by non-woven polyester fabric, covered with a polyethylene film. The proprietary foil-backed lamination on the patch is used to provide an occlusive barrier that prevents any essential oil from being absorbed through the skin. The placebo will consist of a comparable sized felt patch with adhesive backing with no essential oil applied.

Eligibility Criteria:
Inclusion Criteria:

1. Inpatients of acute care setting at University Health hospital
2. Provision of a signed and dated informed consent form
3. English or Spanish speaking
4. Male or Female, aged 18 years and older
5. Willing to comply with all study procedures

Exclusion Criteria:

1. Respiratory disorders, e.g., asthma, chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, lung cancer, cystic fibrosis, pneumonia, pleural effusion
2. Cognitive impairment
3. Unable to communicate
4. Admitted to the closed access unit or to psychiatry
5. Allergic to lavender, mandarin or peppermint oil
6. Diseases that cause olfactory disorders such as: COVID-19, benign growths or polyps, congestion from a cold, sinus infection or allergy flare-up
7. Drugs that may cause loss of the ability to smell e.g., intranasal zinc products, decongestant nose sprays and certain oral drugs such as nifedipine and phenothiazines
8. Pregnant women (self-reported)
9. Prisoner
Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy

Polyp detection rate in colonoscopy following oral administration of MMX methylene blue tablets

Polyp detection rate in colonoscopy following oral administration of methylene blue MMX modified release tablets in subjects undergoing colonoscopy as outpatients.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for screening or surveillance colonoscopy. Written informed consent.Practising reliable contraception or sterile.Ability to understand and comply with the protocol.

Exclusion Criteria:

* Pregnancy or lactation known or suspected hypersensitivity GI obstruction or perforation serious cardiovascular, renal or hepatic disease. reduced prothrombin time,elevated serum creatinine.
A Long-term Follow-up Study of Botulinum Toxin Type A in Patients With Overactive Bladder as a Result of Spinal Injury or Multiple Sclerosis

The purpose of this study is to assess the long-term safety and effectiveness of botulinum toxin type A on patients with overactive bladder as a result of spinal cord injury or multiple sclerosis. This is a follow-up study to two Allergan sponsored studies (NCT00311376 and NCT00461292).

Botulinum toxin Type A 300U has been discontinued from the study. Patients remaining in the arm containing botulinum toxin Type A 300U will receive botulinum toxin Type A 200U moving forward. Also, the masking of the study is now open-label.

Eligibility Criteria:
Inclusion Criteria:

* Patient has participated in study 191622-515 or 191622-516 and the following criteria fulfilled:

  * Patient completed at least 52 weeks in the preceding study.
  * No longer than 6 months has elapsed since completion of the preceding study
  * Patient has not received any prohibited medications during any intervening period between the preceding study and this long-term study.

Exclusion Criteria:

* History or evidence of pelvic or urologic abnormality.
* Previous or current diagnosis of bladder or prostate cancer.