cyrilzakka/clinical-trials huggingface dataset:
Evaluate the Effect of Clarithromycin/Rifampicin on the Pharmacokinetics of DA-8010 in Healthy Adults

This is an open-label, fixed-sequence, phase 1 study to evaluate the effect of clarithromycin/rifampicin on the pharmacokinetics of DA-8010 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteer 19 years to 50 years
* Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to 28kg/m2
* In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in a surgical infertility condition (both tubular obstruction, hysterectomy, bilateral tubular resection, etc.)
* The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
* The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire

Exclusion Criteria:

* Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine, hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic, psychological disease, sexual disorder, ophthalmologic or history of such disease
* Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendix surgery, hernia surgery, hemorrhoid surgery)
* Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
* Subject who is positive for serum test results (hepatitis B test, hepatitis C test, HIV test, syphilis test)
* Subject who have history of drug/alcohol abuse or Positive in Urine drug screen test
* Subject who determined that Investigator is unfit to participate in a clinical trial due to other reasons other than the above items
3D Breast Imaging for Cosmetic and Reconstructive Breast Surgery

The purpose of this trial is to evaluate the impact of incorporating three-dimensional (3D)imaging during preoperative consultation on patient reported outcomes in primary breast augmentation surgery. 3D imaging is an innovative technology that allows the surgeon to share with images how one could look after one's procedure. The patient's assessment will be collected using the Breast Q, an objective questionnaire that captures patient satisfaction with breast augmentation.

Consultation for primary breast augmentation involves clear communication between patient and surgeon to select the implant and manage expectations. Tissue-based planning strategies rely on tissue characteristics and measurements to produce safe and reproducible aesthetic outcomes. The implementation of sizers in the preoperative consultation and a greater emphasis on patient aesthetic goals have also proven to be favorable strategies. Recently, many plastic surgeons have started to incorporate three-dimensional (3D) photography and computer simulation into their preoperative consultation process. The accuracy of computer simulation for volume assessment of breast augmentation is reportedly ≥90%, and patients demonstrate a preference for consultations involving simulation.Support for computer simulation, however, is not unanimous.

Quantitative analyses, prospective study designs, and utilization of validated health-related quality of life metrics have been recommended to more thoroughly scrutinize implant selection systems and outcomes in aesthetic surgery.Mammometrics yields numerical data useful for quantifying changes in breast morphology after breast reduction, reconstruction with implants, and augmentation. The BREAST-Q represents the most comprehensive and quantitative method for patient self-assessment following breast surgery, and has gained traction as a patient-reported outcomes instrument for breast augmentation. To date, there are no studies that focus on the impact of simulation on patient-reported outcomes in breast augmentation, as measured with the validated BREAST-Q. Furthermore, there is minimal data examining correlations between patient-reported outcomes and mammometrics.

The purpose of this study was to conduct a prospective, clinical trial to evaluate the impact of 3D imaging and simulation used during the preoperative consultation on postoperative patient-reported outcomes and quantitative changes in breast morphology. We hypothesized that computer simulation would facilitate patient education and surgical planning, thus leading to quantitatively higher patient-reported outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Scheduled for elective breast augmentation cosmetic procedure.

Exclusion Criteria:

* Breast reconstruction for malignancy
* Cognitively unable to provide informed consent.
The Effects of Oxytocin and Vasopressin on Delta-beta Cross-frequency Coupling

The main aim of the study is to investigate whether intranasal oxytocin and vasopressin have effects on delta-beta cross-frequency coupling under resting-state and task conditions.

A double-blinded, placebo-controlled, between-subject design is employed in this study. In a randomized order, a total of 120 healthy males and females are instructed to self-administer intranasal spray of oxytocin, vasopressin, or placebo. (1) 15-minute resting-state EEG data are collected 35 minutes after treatment. (2) Participants complete tasks including Stroop, GO/NOGO, and anxiety induction with behavioral (response time, accuracy, or rating) and EEG data being collected. Personality traits of subjects are assessed using validated Chinese version questionnaires including the Beck Depression Inventory (BDI-II), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), and Adult ADHD Self-Report Scale (ASRS-v1.1). Participants are asked to complete Positive and Negative Affect Schedule (PANAS) when they just arrive, before resting state and after the tasks. Three blood samples (5 ml) are collected into 6 ml ETDA tubes when participants just arrive, before resting state recording and after all of the tasks.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders.

Exclusion Criteria:

* History of head injury.
* Pregnant,menstruating,taking oral contraceptives.
* Medical or psychiatric illness.
Effects of Respiratory Muscle Training on Postoperative Pulmonary Complications of Cardiac Surgery

This study will evaluate the profilatic effects of inspiratory muscle training (IMT) on functional capacity, respiratory muscle strength, postoperative pulmonary complications and days of hospitalization (PPC) in patients submitted to coronary artery bypass graft surgery (CABG).

Patients undergoing coronary artery bypass graft surgery are at risk of postoperative pulmonary complications, which lead to increased postoperative morbidity and mortality.

A few studies have demonstrated that preoperative physical therapy has advantages over postoperative care in patients undergoing cardiac . In this way, this study aim to investigate the effects of preoperativeinspiratory muscle training in patients at high risk of postoperative pulmonary complications who were scheduled for coronary artery bypass graft surgery.

Eligibility Criteria:
Inclusion Criteria:

* High-risk patients underwent primary elective CABG (Coronary artery bypass graft), High-risk will be defined as 2 or more the following: age\>70 years; cough and expectoration; diabetes; smoker; COPD (Chronic Obstructive Pulmonary Disease)

Exclusion Criteria:

* Uncontrolled arrhythmia,
* Decompensated heart failure,
* Unstable angina upon selection or during the inspiratory muscle training (IMT),
* Need for reoperation and association of another procedure during surgery (e.g. valve correction associated with CABG)
* Severe orthopedic or neurological conditions.
Antibody Response and Longevity Post SARS-CoV-2 Vaccine (SARS-AB)

Longitudinal study on healthy subjects to investigate the longevity of the antibody response to the Pfizer-BioNTech COVID-19 vaccine. Venous blood samples will be collected on an outpatient basis from 400 adults at regular intervals (1, 2, 4, 6, 12, 18 and 24 months) after the second dose of the vaccine. In the event of the administration of a third dose, the participants already recruited will be subjected to a venous blood sample immediately before administration and subsequently at regular intervals (1, 2, 4, 6, 8 and 12 months). A laboratory serological test will be performed for each sample. The expression of humoral biomarkers will be evaluated with the Luminex methodology with the aim of identifying prognostic and predictive biomarkers of the response to the vaccine.

Subject to informed consent, participants will be asked to provide a brief history of any previous SARS-CoV-2 infections and information on serological tests already performed. Subjects will undergo an outpatient venous blood sample at the San Camillo or Villa Salus hospital at regular intervals (1, 2, 4, 6, 12, 18 and 24 months) after the second dose of vaccine. Sample A will be pseudo-anonymized and the serological examination for the detection of antibodies will be carried out in the diagnostic laboratories of Villa Salus and / or in the Neurobiology laboratory of the San Camillo hospital. 5 cc of blood (sample B) will be taken separately and sent to the Neurobiology laboratory of the San Camillo hospital where they will be stored and analyzed in groups for the measurement of serum inflammation mediators (chemokines, cytokines) on a Luminex platform for analysis of a cytokine and chemokine panel (eg Cytokine \& Chemokine Convenience 34-Plex Human ProcartaPlex ™ Panel 1). In the event that among the participants already recruited (200) there are individuals inoculated with a further dose of the vaccine, they will be subjected to a venous blood sample immediately before administration and subsequently at regular intervals (1, 2, 4, 6 , 8 and 12 months). The processing of the samples will take place in the manner described above.

Eligibility Criteria:
Inclusion Criteria:

• healthy adult subjects included in the vaccination program carried out for hospital staff of the San Camillo and Villa Salus hospitals in Venice starting from January 2021

Exclusion Criteria:

• none
Sport Specific Training Versus Neuromuscular Training on Field Rugby Players.

Randomized Clinical Trial in rugby sports club in Lahore. A Sample size of 26 is calculated using epitol.Group A: Sports specific training Treatments will be provided in 30 mins per week for 3 consecutive weeks. Weight programs include closed chain exercises (squats, pushups) and open chain exercises (leg press, chest fly using dumbbell) Stretch shortening cycle (enhances performance through storage of elastic energy during eccentric phase and activation of stretch reflex).

Group B: neuromuscular training Treatments will be provided in 30 mins per week for 3 consecutive weeks Proprioceptive Neuromuscular Facilitation (PNF)

Rugby require constant pace changes that generates high musculoskeletal demand in rugby one of the commonly affected area is low back pain that can affect player performance and can be accelerated by injury, health and lifestyle factors and possibly by joint pain or musculoskeletal disorders. Data will be collected from players in registered rugby clubs of district Lahore. Informed consents will be taken from all participants with the knowledge of aims and procedure. The results of this study will help to improve treatment protocols options for players how it affects the rehab process and how it affects the movement and pain how it affects the rehab process and how the pain restricts movements among rugby players. This study will be based on a randomized clinical trial used to study the different level of effectiveness of sports specific training versus neuromuscular training on dynamic balance mobility, flexibility in field rugby players. Subjects with low back pain meeting the predetermined inclusion \& exclusion criteria will be divided into two groups by randomization to avoid any plagiarism. Dynamic Balance, measured with Star Excursion Balance Test; Active Range of Motion (ROM), using a manual goniometer and Lumbar Flexibility, assessed with Fingertip-to-floor test will be used for data collection. Subjects in one group will be treated with Bilateral stretches, contract-relax PNF stretching training and other will be treated with weight training, aerobic exercises. Each subject will receive a total four weeks treatment session, thirty minutes sessions will be performed once a week for three weeks. Three evaluations will be performed once before treatment One week after treatment and four week post treatment follow-ups. Sample size 26 each group contains 13 participants. All statistical analysis will be performed with spss16.0.

Eligibility Criteria:
Inclusion Criteria:

* Female rugby players
* Who had suffered minor musculoskeletal injuries that did not preclude their sports participation.
* Age ranges from 16-30
* Being able to cooperate

Exclusion Criteria:

* Players presenting injuries which implied radicular compromise (sciatic pain, etc.)
* Players who had suffered moderate or severe musculoskeletal injuries in the past 6 months which precluded their normal sports participation.
* Traumatic pain, fractures or ruptured ligaments.
* Inflammatory and Infectious conditions
* Any recent surgical intervention
* Tumors/malignancy of bone
Elders Preferences in Care Decisions

The purpose of this research study is to explore ways to improve appropriate colorectal cancer (CRC) screening in the elderly by attempting to target screening in those most likely to benefit and avoiding screening in those least likely to benefit.

The investigators propose a randomized controlled trial at the patient level to determine the efficacy of a colorectal cancer screening decision support intervention for patients ages 70 to 84 within a clinical setting. The investigators hypothesize that the use of the intervention will prepare patients for individualized decision making with their providers and result in an improvement in appropriate CRC screening decisions and screening outcomes. To assess appropriate CRC screening decisions and screening, the investigators will use a classification scheme derived from the literature based on age and the Charlson Comorbidity Index. Using this scheme, appropriate screening will include screening for those in the best health because they are likely to benefit, no screening for those in the worst health because they are unlikely to benefit, and evidence of a discussion about CRC screening for those in the intermediate health group because the benefit is unclear.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 70 to 84
* Not up to date with colon cancer screening or surveillance

Exclusion Criteria:

* Men and women younger than 70 years of age or older than 84
* History of Colorectal Cancer
* Inflammatory bowel disease
Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The ability for patients with COPD to exercise is limited due to the deterioration of their lung function. NVA237 is being developed to treat COPD. This study is designed to look at how well NVA237 improves the ability to exercise in patients with moderate to severe COPD.


Eligibility Criteria:
Inclusion Criteria:

* Patients who signed an Informed Consent Form prior to initiation of any study-related procedure
* Patients with moderate to severe stable COPD (clinical diagnosis in compliance with GOLD 2008)
* Current or ex-smokers with a smoking history ≥ 10 pack years. (Ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.).
* Patients with a post-bronchodilator FEV1 ≥ 40 and \< 70% of the predicted normal, and postbronchodilator FEV1/FVC \< 0.7 during screening. (Post referred to the highest post-bronchodilator value after inhalation of 80 μg ipratropium bromide)
* Increase in FEV1 from pre- to post-bronchodilator assessment of ≥ 5%

Exclusion Criteria:

* Pregnant women or nursing mothers
* Women of child-bearing potential
* Patients who had a COPD exacerbation (whether hospitalized or not) in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 4
* Patients who had a lower respiratory tract infection in the 6 weeks prior to Visit 1
* Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia
* Patients with resting (5 min) oxygen SaO2 (or SpO2) saturation on room air of \< 85%
* Patients with a maximum workload (Wmax) value \< 20 W (as determined by the incremental cycle endurance test) at Visit 2.
* Patients whose exercise endurance time at sub-maximal workload was above 25 min at baseline
* Patients with a clinically significant abnormality on the screening or baseline ECG who in the judgment of the investigator would have been at potential risk if enrolled into the study
* Patients with a history of long QT syndrome or whose QTc was prolonged (\> 450 ms for males and \> 470 ms females) at screening (Fredericia's correction)

Other protocol-defined inclusion/exclusion criteria applied
Effectiveness of Dry Needling in Shortened Triceps Surae Muscle

To date, there are not studies about the effectiveness of dry needling versus ischemic compression in the triceps surae trigger points. A randomized clinical trial is carried out. A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic compression (n = 15). Outcome measurements such as dorsal flexion range of motion, plantar pressures, temperature, superficial muscle activity and trigger points pressure pain threshold are measured immediately before and after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Myofascial pain syndrome in the triceps surae muscle, limitation of ankle dorsal flexion range of motion.

Exclusion Criteria:

* Neurologic disorders, pharmacologic treatment (within the previous 3 months), cognitive impairment, prosthesis in the lower limb, systemic or infectious diseases, autoimmune diseases, fibromyalgia, hypothyroidism, anticoagulants or antiplatelet agents, and fear of needles.
Compliance and Usability Study Evaluating RHINIX™ Nasal Filters

This study will investigate usability and compliance related to rhinix nasal filters for the treatment of seasonal allergic rhinitis (hay fever) during the natural grass pollen season in Denmark.


Eligibility Criteria:
Inclusion Criteria:

* Motivated to try a different treatment approach to seasonal allergic rhinitis (documented by answering the call-out by Astma-Allergi Danmark)
* Indicates having seasonal allergic rhinitis to grass via online questionnaire
* Informed consent (by email acceptance after having received information on the trial)
* Assess to internet and email

Exclusion Criteria:

* Improper fit of the Rhinix™ device
Pain Reduction for Limb Injuries in Pediatric Emergency Departments: Intranasal Fentanyl or Intranasal Ketamine Vs Oral Morphine

The purpose of this study is to determine if IN fentanyl (1.5 µg/kg) or IN ketamine (1 mg/kg) is more effective at 30 minutes than oral morphine (0.5 mg/kg) in reduction of moderate and severe pain associated with limb injuries in patients 2-17 years of age presenting to the ED.

In children with moderate to severe pain due to musculoskeletal injuries, the first-line analgesic therapy in pediatric emergency departments (ED) is oral or intravenous morphine. Due to the delay or discomfort associated with establishing IV access, oral forms are preferred in French ED. Unfortunately, oral morphine alone or with ibuprofen or paracetamol, none regimen is optimal for relieving pain in children with traumatic limb injuries. However, the use of intranasal course is a safe route that can provide rapid and almost immediate analgesia. Intranasal administration is easy, non-invasive and usually well tolerated by children. In the last years, drugs with analgesic and sedative properties is increasing, particularly on fentanyl, ketamine, which can be also administered by the IN route. There are currently no studies, neither published nor ongoing, which compare IN fentanyl or IN ketamine to a standard oral morphine for children with acute moderate to severe pain with limb injuries presenting to the ED. The main hypothesis is that the efficacy of the analgesia 30 minutes after the administration will be higher with IN Fentanyl or with IN Ketamine, when compared to oral morphine.

Eligibility Criteria:
Inclusion Criteria:

* Child aged 2 years to 17 years and 11 months
* With 10 kg ≤ Weight ≤ 100 kg
* Presenting to ED with a traumatic pain and suspected fracture(s) based on an acute deformity AND experiencing pain and/or functional impotence in the injured limb(s)
* Within the first 12 hours after the injury
* VAS pain score at ED arrival ≥ 60/100 (if child ≥ 7 years) or Evendol pain score at ED arrival ≥ 7/15 (if child \< 7 years)
* Affiliated to health insurance
* At least one signed parental informed consent

Exclusion Criteria:

* Received narcotic pain medication prior to arrival
* Contraindication to morphine, mentioned in SmPC
* Hypersensitivity to ketamine or fentanyl or to excipients (sodium chloride, sodium hydroxide), or to other opioids.
* Contraindication to fentanyl or ketamine, mentioned in SmPC
* GCS \<15
* Evidence of significant femur, head, chest, abdominal, or spine injury
* Open fracture
* Nasal trauma or complete nasal obstruction
* Active epistaxis
* Nasal or sinus surgery within 6 months before inclusion
* History of high blood pressure, known coronary artery disease, congestive heart failure, acute glaucoma, increased intracranial pressure, major psychiatric disorder, hepatocellular insufficiency
* Active or history of psychiatric disorder
* Known pregnancy or suspicion of being pregnant
* Breastfeeding
* Non-French speaking parent and / or child.
* Participation to another interventional clinical research
Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas

This trial is a prospective, exploratory and descriptive study. The primary objective is to identify early diagnostic biomarkers in patients with TIPMP based on the analysis of Treg lymphocyte subpopulations and epigenetic signatures, and the secondary objective is to characterize the biological processes underlying the transformation of a pre-neoplastic lesion into established ADPC.

To meet the objectives of the study, patients will have blood samples taken at the time of their TIPMP monitoring, i.e. at inclusion, 6 months, 1 year and 2 years. If echo-endoscopy is performed during MRI monitoring of their disease, and a sample is taken as part of the treatment, a tumor sample and an intra-cystic fluid sample will be collected as part of the protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 18
2. Patient with intermediate-risk or high-risk TIPMP according to the European Study Group on Cystic Tumours of the Pancreas (3)
3. Signed consent to participate
4. Affiliation with a social security scheme, or beneficiary of such a scheme.

Exclusion Criteria:

1. Pregnant or breast-feeding woman
2. Person in an emergency situation or unable to give consent.
3. Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
4. Unable to undergo medical follow-up for geographical, social or psychological reasons.
5. contraindication to MRI.