cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin

This study is designed to provide data about the pharmacokinetics (PK), safety and tolerability of two continuous treatment regimes of tobramycin nebulized solution delivered via a 'soft mist' nebulizer in Cystic Fibrosis (CF) subjects. Each treatment period will last 8 weeks. Additionally the PK of patients with a normal forced expiratory flow in 1 second (FEV1) (FEV1≥80% predicted) will be compared to patients with an abnormal FEV1 (FEV1\<80% predicted).


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged ≥6 years at the time of screening, with an Informed Consent Form signed by patient and if appropriate by parent/legal guardians, prior to any study-related procedure.
* Confirmed diagnosis of CF by the presence of one or more clinical features of CF in addition to a quantitative pilocarpine iontophoresis sweat chloride test of \>60 mEq/L; or identification of well-characterized disease-causing mutations in each CFTR gene; or an abnormal nasal transepithelial potential difference characteristic of CF.
* P aeruginosa must be present in sputum or deep throat swab (or bronchoalveolar lavage \[BAL\]) at the screening visit and within 6 months prior to screening.

Exclusion Criteria:

* History of sputum (or BAL) culture yielding Burkholderia cepacia (B cepacia) within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.
* FEV1 \<25% of normal predicted values for age, sex, and height based on Knudson criteria at screening.
* Hemoptysis of more than 60 cc at any time within 30 days prior to study drug administration.
* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
* GFR\<60ml/min/1.73m2 calculated with the Formula by Schwartz, BUN 40 mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria.
* History of tinnitus or pathologic audiometry
* diagnosis of Allergic bronchopulmonary aspergillosis (ABPA) at screening
* Initiation of treatment with macrolide antibiotics within 28 days prior to study drug administration (subjects may be taking macrolide antibiotics at the time of enrollment, but they must have initiated treatment at least 28 days prior to study drug administration).
* Use of loop diuretics within 7 days prior to study drug administration.

Other protocol-defined inclusion/exclusion criteria may apply
Interest in Using Ultrasound Fusion in Percutaneous Interventional Radiology

The investigators want to evaluate the accuracy of an ultrasound fusion guiding system in the positioning of a needle (here the accuracy is evaluated with a 22G spinal needle), by comparing the path indicated by the ultrasound fusion (virtual line) and the path actually obtained on the control CT scan (real line).

Compared with ultrasound guidance alone or CT scan alone, the results are expected to be more accurate, saving time and irradiation (not evaluated here).


Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* male or female
* women of childbearing potential should use effective contraceptive measures and indicate the date of the last menstrual
* Patient requiring the use of computed tomographic guidance to perform a diagnostic (biopsy) or therapeutic procedure (infiltration, ablation) on a mobile organ
* patient signed an informed consent

Exclusion Criteria:

* Contraindications to the use of X-rays (pregnancy)
* Patients using vital electronic devices (eg: pacemaker or defibrillator)
* Subject under judicial protection
* Subject under tutorship or curatorship
* Inability to give informed informations (subject in emergency situations, comprehension difficulties of the subject, ...)
Efficacy and Safety of Fluvastatin in Children With Heterozygous Familial Hypercholesterolemia

The purpose of the study is to assess the safety and efficacy of fluvastatin in children diagnosed with heterozygous familial hypercholesterolemia


Eligibility Criteria:
Inclusion Criteria:

* 10-16 years old Heterozygous familial hypercholesterolemia

Exclusion Criteria:

* Homozygous familial hypercholesterolemia Pregnant or lactating females Major surgery during the six month prior study

Other protocol defined inclusion and exclusion criteria may apply
Early Surgical Intervention of Congenital Hemivertebra in Young Children

Early treatment of congenital hemivertebrae is very important. The investigators design this study to figure out how early hemivertebrae resection be apply to children. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into early operation group and control group. The early operation group will undergo posterior hemivertebra resection. The control group received brace plaster fixation to reduce the progression of scoliosis, and then will undergo operation after 5 years old. Primary Outcome Measure is the length of spine surgery.

Early diagnosis and early effective treatment of congenital hemivertebrae can correct the deformities.Therefore, traditionally, children with a clear diagnosis should be fixed with a brace to delay the aggravation of scoliosis and then undergo surgery after 5 years of age. The design of this study is to conduct a single-center randomized controlled study. Children aged 3-5 years old diagnosed as congenital hemivertebrae will be randomly divided into the early operation group and the control group. The early operation group will undergo posterior hemivertebra resection. The control group received brace plaster fixation to reduce the progression of scoliosis, and posterior scoliosis correction will be performed after the age was over 5 years old. The primary outcome measures are the length of spine surgery for the two groups of children. The secondary outcome measures are change of scoliosis cobb angle, by comparing preoperative and postoperative cobb angle changes. It is expected that the early treatment group will shorten the length of surgery due to the smaller degree of scoliosis. Our research is expected to broaden the age-adaptation of classic spinal surgery in the field of pediatric spine.

Eligibility Criteria:
Inclusion Criteria:

* Single-segment thoracic or lumbar hemivertebrae scoliosis diagnosed by X-ray and CT.

Exclusion Criteria:

* Diagnosed with syndrome of scoliosis, osteochondrodysplasia, multi-segment hemivertebrae deformity, cervical hemivertebrae deformity
Comparing Warm Versus Cool Temperature Water During Colonoscopy

The purpose of this study will be to determine if the temperature of water used during insertion of colonoscopy makes a difference in patient discomfort and sedation requirements. The hypothesis of this study is patients receiving screening colonoscopy utilizing the water insertion method with room temperature (cool) water will have similar pain scores and medication requirements compared to water insertion method using body temperature (warm) water.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 to 85 years undergoing elective outpatient screening colonoscopy for colon cancer screening

Exclusion Criteria:

* Patients undergoing colonoscopy for any other indication besides colon cancer screening
* Patients with prior colonic resections
* Patients with chronic narcotic or benzodiazepine use
* Poor bowel preparation (i.e. Boston bowel preparation score \< 8)
* Patients with obstructing colonic lesions detected on colonoscopy
Oxidative Stress in Women Treated With Atosiban for Impending Preterm Birth

Oxidative stress is recognized as a important factor in the pathogenesis premature birth. Preterm birth is defined as delivery before 37 completed weeks of gestation and it is the leading cause of neonatal morbidity and mortality. The investigators conducted this analysis to investigate the safety of administration of Atosiban - a reversible, competitive antagonist of the oxytocin receptor in the treatment of preterm labor and its impact on the level of oxidative stress after 48 hours of tocolytic treatment.

Atosiban (1-(3-mercaptopropanoic acid)-2-(O-ethyl-D-tyrosine)-4-L-threonine-8-L-ornithine-oxytocin) is licensed for clinical use in women suffering from threatened premature birth and is widely used in clinical practice in Europe because of its low side effect profile. The impact of Atosiban on pregnancy outcomes in women has been investigated in recent years and the research has shown its ability to reduce intracytoplasmic calcium release and downregulate prostaglandin synthesis as oxytocin receptor antagonist. While a role of Atosiban in the modulation of myometrial contractility is well-described, its effect on many other functions is not so well known.

The serum and plasma samples take for the measurement of total oxidant status (TOS), total antioxidant status (TAS), level of 3-nitrotyrosine (3-NT), and carbonyl and thiol groups will be stored at -70°C in aliquots for subsequent biochemical analysis and processed within two months.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women between 24-35 weeks' gestation receiving prenatal care due to the risk of premature birth
* intact membranes
* evidence of premature labor (regular, painful and persistent uterine contractions; cervical changes)

Exclusion Criteria:

* acute fetal distress
* other conditions requiring immediate delivery (eclampsia and severe pre-eclampsia, placenta previa, abruptio placenta)
* vaginal bleeding,
* premature rupture of membranes
* chorioamnionitis,
* fetal congenital malformations,
* intrauterine growth restriction,
* the use of any tocolytic drugs during pregnancy before admission to the hospital
* circulatory system diseases (e.g. heart defects, hypertension),
* symptoms of infection
* other diseases that may increase oxidative stress
High-fidelity Simulation in Health Care Education

The purpose of this study is to determine whether the use of high-fidelity simulation in health care education is an effective training and evaluation model.

High-fidelity simulation has many advantages in medical education. Simulation-based critical care training is especially valuable due to error-prone work settings and the high cost of patient adverse events. This study was conducted to assess the effectiveness of implementing the high-fidelity simulation in critical care training, and the feasibility of high-fidelity simulation as an evaluation tool.

Eligibility Criteria:
Inclusion Criteria:

* healthcare trainees, including medical students, nursing students, residents, nursing staff and emergency medical technicians.

Exclusion Criteria:

* any trainees unwilling to receive simulation-based training
Assessment of Impact of Inspiratory Muscle Training on Movement Fear Due to Dyspnea in Chronic Obstructive Pulmonary Disease

In our study, it was aimed to evaluate the effect of inspiratory muscle training on fear of movement due to dyspnea in COPD patients. Participants will be randomly assigned to two groups. Inspiratory muscle training in the training group will be administered at least 5 days a week, 15 minutes twice a day, beginning at 30% of the MIP for 8 weeks. Patients will come to the control once a week, the MIP values will be re-measured and the new training intensity will be determined at 30% of the new value. For the control group, a fixed training session will be given for at least 5 days a week, 15 minutes twice a day, not exceeding 15% of the MIP for 8 weeks.

Pulmonary diseases are a common cause of mortality and morbidity worldwide. Chronic Obstructive Pulmonary Disease (COPD) causes respiratory muscle weakness, but also causes hypercapnia, dyspnoea, oxygen desaturation, and gait disturbances. In COPD, the main symptom is dyspnea and leads to activity limitation. It has been shown that with exercise, the diaphragm workload increases in COPD patients and requires more MIP than healthy humans. This is associated with dyspnea during exercise and tiredness in the respiratory muscles. Dyspnea is defined as the difficulty in breathing of a person. Painful situations are defined as 'kinesiophobia' as a result of physical injuries and fear of repetition of the problem as a result of injury. Similarly, COPD patients avoid themselves from dyspnea-related activities or compensate by reducing the rate of activity. This reduces the severity of the symptom that precedes the symptom that may occur. As a result, fear of movement occurs due to dyspnea. Decrease in the level of activity; social isolation, fear of dyspnea, depression and anxiety result in a stubborn cycle, reducing the quality of life. In order to increase respiratory muscle strength and endurance, to improve the length tension relationship of respiratory muscles and to increase respiratory capacity, respiratory muscle training is performed by using the training principle of skeletal muscles. In COPD, inspiratory muscle training has been shown in many studies to reduce dyspnoea perception, increase exercise capacity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* FEV1/FVC\<%70
* To be able to read and understand Turkish

Exclusion Criteria:

* Having undergone a COPD exacerbation in the last 6 weeks
* Having comorbidities affecting ambulance
* Having cognitive disorders
Transcranial Direct Current Stimulation and Autism

This research is being done to determine whether transcranial direct current stimulation (tDCS) can improve certain mental abilities, such as speech, language and other efforts at communication in individuals with autism.

In this research, battery powered device is used to deliver very weak electrical current to the surface of the scalp while participants are involved in tasks aimed at training or measuring communicative efforts, speech, language or related cognitive functions. Our aim is to find out whether tDCS will improve these mental abilities.

Participants in the study will be asked to do the following things:

* Grant permission for the researchers to view medical/psychological and/or educational and/or speech records associated with the diagnosis of low-functioning autism.
* Complete a questionnaire and provide a health history.
* Complete evaluations by our study team to assess the diagnosis and gain a clearer understanding of the participant's current functioning.
* Give permission to audio and video-tape test sessions for later scoring and observation.
* Give permission to audio or video-tape in the classroom or home environment using non-intrusive audio-visual recording devices.
* Complete several tasks and training interventions that involve such things as learning new words or pictures, saying words out loud, or naming objects.
* Participate in an eye tracking study while completing a task on the computer which involves wearing a headband, attached by a velcro fastener, which contains a magnetic sensor. This equipment allows us to track the position of the head in order to record more accurate measurements. It is used with eye tracking equipment which measures the gaze on a set point on a computer screen. The equipment poses no risk and is non-invasive.
* Participate in computerized tasks while monitoring brain responses that are a direct result of a thought or perception. In order to monitor these responses, electrodes would be placed over various points on your scalp. The electrodes will record the on-going activity of the brain; it does not produce or introduce any electrical activity. The equipment poses no risk and is non-invasive.
* Wear electrodes that will be placed on the scalp with a large rubberized band. These electrodes will administer very weak electrical current (tDCS) from a battery powered device for 20 to 60 minutes.

The experimental sessions will last about 1 hour and participants may be asked to have more than one testing session in a day or to return for additional sessions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of autism or related conditions
* Identified language deficit(s) and/or other cognitive or behavioral impairments (which will be specific to each sub-study)
* Adequate ability to perform the research tasks set for the individual's particular level of performance

Exclusion Criteria:

* Peripheral blindness or deafness
* Any implanted metal device (precludes use of tDCS)
* Any implanted cardiac pacemaker
Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease

The purpose of the study is to learn whether people who are experiencing an MCD (multicentric Castleman's Disease) flare will improve after taking valganciclovir. MCD is a type of inflammatory disease associated with Human Herpesvirus 8 (HHV-8). Valganciclovir is FDA approved for treating a different type of Human Herpesvirus, but not approved for the treatment of HHV-8. It is therefore considered experimental in this study.

All participants will undergo an initial screening appointment. At this visit, participants will be tested for Human Herpesvirus 8 (HHV-8), the virus that is associated with MCD, and we will review participants' medical history and medical records to determine whether he/she has MCD. If participants do not live within the Seattle area, this visit may occur over the phone.

Those who qualify for the study will be followed for up to 2 years. During that 2 year period, participants will be asked to collect oral swabs once a week and have blood drawn monthly. If subjects do not live within the Seattle-area, they will be asked to ship these samples to UW for testing. We will provide subjects with instructions for these shipments. This will be done at no cost to the participant.

If during the 2 year period the participant experiences a MCD flare, he/she will be admitted to the University of Washington Medical Center's Clinic Research Center for 14-days. If the participant does not live within the Seattle-area, all travel expenses will be covered.

The study will enroll a total of 8 patients who will receive open-label valganciclovir for 14-days. Everyday during the hospitalization, participants will have blood drawn (to check your HHV-8 levels), 1 oral swab will be collected and a general physical exam will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years
* Negative pregnancy test (for female participants)
* Diagnosis of MCD for over one year, with a history of at least one MCD recurrence annually
* Evidence of infection with HHV-8
* A willingness to travel and reside temporarily in Seattle for completion of the study protocol.
* For HIV-infected participants, a stable antiretroviral regimen for the past 6 months

Exclusion Criteria:

* Concurrent Kaposi sarcoma or non-hodgkin's lymphoma
* A history or evidence of CMV disease
* Hypersensitivity to ganciclovir or valganciclovir
* Use of high-dose acyclovir (\>800 mg bid), valacyclovir (\>1000 mg qd) or famciclovir (\>1000 mg qd), ganciclovir, foscarnet, or cidofovir
* Neutropenia (ANC \<1500)
* Renal insufficiency with serum creatinine \> 1.5 mg/ml or CrCl \< 60
* AST or ALT \> 5 times upper limit of normal
* Concurrent administration of medications which are often associated with severe neutropenia or thrombocytopenia (i.e., chemotherapy, etc)
* Concurrent administration of probenecid or didanosine.
* Inability to read and understand English
Evaluation Of Striatal Glucose Metabolism With Positron Emission Tomography Following PF-02545920 In Healthy Subjects

We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain called the striatum.


Eligibility Criteria:
Inclusion Criteria:

* Healthy right-handed male and female subjects between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)
* An informed consent document signed and dated by the subject
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Women of reproductive potential
* History of agranulocytosis or movement disorder
* Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI) contraindications
Safety and Efficacy of YPEG-rhG-CSF in Cancer Patients Receiving Chemotherapy

This study is to examine which dose of YPEG-rhG-CSF, once-per-cycle, has similar efficacy and safety, comparing to PEG-rhG-CSF, once-per-cycle, in chemotherapy-induced neutropenia


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-small cell lung cancer or Breast cancer, and adequate for carboplatin combined with taxol or cyclophosphamide combined with pharmorubicin chemotherapy
* Karnofsky Score ≥ 70
* Life Expectancy \> 3 months
* Age: 18～70yrs.
* Peripheral blood test: WBC≥3.5×106/mm3, PLT≥100×106/mm3, ANC≥1.5×106/mm3; Normal bone marrow function; Bone marrow biopsy shows active hematopoietic without cancer cells.
* Normal coagulation function, no evidences of hemorrhage tendency.
* No exiting diseases or condition that may influence drug absorption, distribution, metabolism, and excretion.
* Adequate liver, cardiac, kidney function. Indicators of liver function test ≤ 2.5ULN, Indicators of kidney function test ≤ 1ULN
* Understand and voluntarily sign an informed consent form.

Exclusion Criteria:

* Pregnant or lactating females
* Evidence of tumor metastasis in bone marrow
* Lack insight due to tumor metastasis in the central nervous system
* Prior bone marrow transplant or stem cell transplant
* Infective symptom before enrollment into this study
* Other malignancy history
* Known hypersensitivity to any component of the drug(e.g. rh-G-CSF) that to be administered
* Subject enrolled in any other investigational drug or device trial within 3 months of informed consent date
* Drug abuser or alcoholist
* Prior radiotherapy or expected to received radiotherapy
* Unstable or uncontrolled cardiac or hypertension
* Other conditions which in the opinion of the investigator preclude enrollment into the study
Effect of Tegoprazan for Elective Surgery Patients Under General Anesthesia

The aim of this study is to compare gastric pH right after endotracheal intubation for general anesthesia in patients pretreated with tegoprazan, famotidine, or placebo.

This clinical trial is a prospective, randomized, double-blind, multicenter, investigator-initiated trial that aims to demonstrate the preventive effect of tegoprazan on preoperative aspiration in patients scheduled to undergo surgery using general anesthesia.

Subjects who meet the inclusion/exclusion criteria will be randomly assigned to the tegoprazan administration group (Group T), famotidine administration group (Group F), or placebo administration group (Group C) in the same ratio of 1:1:1.

Eligibility Criteria:
Inclusion Criteria:

1. Has a plan to undergo surgery with general anesthesia with inhalation or total Intravenous
2. Subjects aged between 20 and 69 years
3. ASA classification I - III

Exclusion Criteria:

1. Conduct Emergency surgery
2. BMI(Body Mass Index) ≥ 35
3. Has a history of drug abuse or depandency.
4. Has a history of Anesthetic allergy
5. Has a plan to undergo resection(gastric cancer, esophageal cancer)