cyrilzakka/clinical-trials huggingface dataset:
Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy

To study the effect of different doses of sufentanil on anesthesia induction and analgesia after tonsillectomy in children. According to the different doses of sufentanil used in anesthesia induction, the children were divided into 3groups. The vital signs during anesthesia, the recovery period of anesthesia and the complications after anesthesia were compared among the groups. The anesthetic effects and safety of sufentanil at different doses were discussed, which provided theoretical basis for clinical selection of the best drug dosage.

Fifteen minutes before operation, midazolam 0.1 mg/kg was slowly intravenously injected. Five minutes later, the child entered the operating room. Pi, Narcotrend, blood pressure, ECG, SpO2 and body temperature were monitored. Penehyclidine hydrochloride 0.01 mg/kg, dexamethasone 0.1 mg/kg, propofol 3 mg/kg, sufentanil (0.3μg/kg, 0.4 μg/kg, 0.5 μg/kg) were given during anesthesia induction. cis-atracurium 0.15 mg/kg, using the required type of tube for tracheal intubation. Sevoflurane 1.0 MAC + remifentanil 0.15 ug/kg/min 50% oxygen was given during anesthesia maintenance. Effective analgesia was achieved by adjusting the dosage of remifentanil during operation.

The changes of vital signs including perfusion index, Narcotrend, Bp, HR, oxygen saturation were observed before anesthesia induction, immediately after tracheal intubation, during tonsillectomy and adenoidectomy during operation, after extubation and in the recovery room. Then record the recovery time, restlessness and pain score during recovery period, postoperative pain, nausea and vomiting and other complications.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-12 years,
* ASA I-II grade;
* selective adenotonsillectomy
* BMI 18.5～23.9,
* Sign informed consent

Exclusion Criteria:

* Emergency surgery;
* Abnormal liver and kidney function
* severe dehydration and malnutrition or Hb \< 10g/dl;
* BMI \<18.5 or \<23.9;
* Children with neurological disorders
A Study To Assess The Duration Of Action Of PF-03526299 In Asthmatic Subjects Following Allergen Challenge

The purpose of this study is to find out how long the effect of PF-03526299 last after it is inhaled by assessing the lung function of mild asthma patients after they have been exposed to allergen

To assess duration of action of the compound in suppressing the early and late allergen response in asthma patients

Eligibility Criteria:
Inclusion Criteria:

* Male and/or female subjects between the ages of 18 and 60 years, inclusive.
* A history or diagnosis of asthma that requires the use of beta 2 agonist bronchodilators (eg Salbutamol).
* Women who could become pregnant must use appropriate birth control throughout the study and pregnancy tests must be negative on entering the study and prior to dosing in the clinic.

Exclusion Criteria:

* Subjects who have been hospitalized for the treatment of asthma within three months prior to study entry, or have been hospitalized more than twice in last 12 months.
* Subjects who have experienced a lower respiratory tract infection (eg bronchitis or pneumonia) or significant asthma instability in the 4 weeks prior to study entry.
* Severe additional disease other than asthma
Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers

The primary objective of this study is to determine if rifaximin, administered daily has an effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.

This is a single-site, single-arm, open-label, drug-interaction study that examines the effect of rifaximin (RFX), 550 mg 3 times daily (TID; 1650 mg/day), on orally administered (PO) midazolam (MDZ) 2 mg (administered as a 2 mg dose in 1 mL of midazolam HCL Syrup; 2 mg/mL) when dosed for 7 and 14 consecutive days, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Patient is medically normal
* Patient has normal laboratory values
* Patient has the ability to understand the requirements of the study

Exclusion Criteria:

* HIV
* Hepatitis B
* Hepatitis C
* History of renal, hepatic, endocrine, oncological, gastrointestinal or cardiovascular disease.
* History of epilepsy, asthma, diabetes, psychosis, glaucoma or severe head injury.
Bioequivalency Study of Torsemide Tablets Under Fed Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Torsemide Tablets, 20 mg, to Demadex® Tablets, 20 mg (Roche) under fed conditions using a single-dose, 2-treatment, 2-period, crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Torsemide or any comparable or similar product.
Dynamic CT Myocardial Perfusion Imaging

This study aims at evaluating the feasibility of CT myocardial perfusion imaging in daily clinical practice and compare it to SPECT perfusion imaging in order to assess sensitivity and specifity of CT myocardial perfusion imaging compared to SPECT.

If after the clinically indicated CCTA a myocardial perfusion examination is indicated, first a single ultra low dose CT scan will be performed to look for late enhancement of potentially scarred myocardium. Together with the contrast agent co-injection of the clinically indicated tracer 99mTc-Tetrofosmin will be performed for later scintigraphic perfusion evaluation. After stress perfusion imaging CT rest perfusion imaging will be performed in a similar fashion. After acquisition of CT rest perfusion images scintigraphic stress and rest image acquisition will be performed as in daily clinical routine with an additional administration of 99mTc-Tetrofosmin resting dose if necessary.

CT stress and rest perfusion will be compared to the clinically indicated and well established SPECT examination.

Eligibility Criteria:
Inclusion Criteria:

* Referral for cardiac hybrid imaging with CCTA and SPECT
* Male and Female subjects 18 years of age or older,
* Written informed consent by the participant after information about the project

Exclusion Criteria:

* Contraindications for CCTA (including renal failure with a GFR \<60ml/min/1.73m2, allergies to ionidated constrast agents)
* Inability to follow the examination procedure due to language barriers, mental disease, dementia etc.
* Pregnancy or breast feeding
* Known allergies to iodinated contrast agent (Visipaque ®), 99mTc-Tetrofosmin (Myoview ®), betablockers (Beloc i.v. ®) or nitrates (Isoket -Spray®)
* Hypersensitivity to adenosine
* Asthma bronchiale
Identification of Minimum Focal Points in Vision Curve Formation

The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery.

This is a prospective, non-inferiority trial. 80 participants that underwent uncomplicated pseudophakic presbyopia surgery with bilateral premium intraocular lenses (IOL) implantation will be recruited, and their postoperative Visual Curves (VAC) will be evaluated for nine distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Then, using polynomial and spline interpolation methods on the measured data, the aim is to generate a unique polynomial of degree ninc -1 that satisfies all data points.

Eligibility Criteria:
Inclusion Criteria:

* age over 40,
* previous bilateral premium cataract surgery,
* best corrected visual acuity (BCVA) \< 0,2 logMAR

Exclusion Criteria:

* taking topical medication to reduce intraocular pressure (IOP),
* macular diseases,
* corneal diseases,
* inability to understand the procedure,
* postoperative astigmatism \>1.50 diopters,
* postoperative clouding of the posterior capsule
Efficacy of Face Mask in Reducing Respiratory Allergic Symptoms in Birch-allergic Subjects in ALYATEC Exposure Chamber

There is no clinical evidence that face masks are efficient in birch pollen-induced asthma. As the use of face masks has become widespread worldwide to limit the spread of SARS-CoV-2, this study aims to demonstrate the clinical efficacy of medical masks in patients allergic to birch in the same way that clinical trial with drugs.

All patients should have positive skin prick tests and specific IgE to birch at screening visit. 24 patients with asthma response during 1-hour baseline exposure to airborne Bet v 1 in ALYATEC environmental exposure chamber.will be randomized into 2 groups: with (n=12) and without (n=12) a KOLMI® surgical face mask (OP-Air), for a 6-hour exposure to birch allergen.

Allergic symptoms will be observed during the 6-hour exposure and compared between the 2 different groups (with and without face mask) to evaluate the efficacy of the face mask.

Eligibility Criteria:
Main Inclusion Criteria:

* Subjects who signed the written informed consent,
* Subjects covered by health social identification number,
* Subjects able to understand and complete study-related procedures,
* Subjects reported history of symptomatic birch pollen allergen-triggered asthma (GINA1) with associated allergic rhinitis,
* Positive skin prick test (SPT) with cat hair extract with mean wheal diameter ≥ 5 mm compared to negative control (NaCl reaction \< 2 mm),
* Positive sIgE tests for birch tree pollen and Bet v 1 (≥0.7 kUa/L),
* Subjects with FEV1 ≥ 70% predicted at screening and before allergen exposure,
* Subjects with at least one drop in FEV1 ≥20% during the 1-hour baseline exposure
* ACT≥ 20,
* Women of childbearing potential with a negative pregnancy test throughout the study period and a highly effective contraception: oral contraceptives, condom with spermicide, intrauterine device, bilateral tubal ligation, vasectomized partner.

Main Exclusion Criteria:

* Allergen immunotherapy to birch pollen allergen for more than 1 month in the 3 years prior to the screening visit,
* Ongoing allergen immunotherapy to another allergen,
* History of anaphylactic reactions to birch allergen exposure or birch allergen immunotherapy,
* History of anaphylactic reactions to another allergen in the last 6 weeks before inclusion,
* Nasal polyposis, deviation of nasal septum or diagnosis of uncontrolled non-allergic rhinitis,
* Subjects allergic to indoor environmental allergens (molds, house dust mite allergens) with obvious exposure to these allergens causing allergic symptoms,
Safety and Efficacy of Low-Fluence PRP for PDR

To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetics
* Proliferative diabetic retinopathy

Exclusion Criteria:

* Previous treatment with PRP
* Media opacities
* Previous treatment for macular edema (LASER or intravitreal injections)
* Recent (less than 6 months) ophthalmic surgery
* Only eyes
* Intra-retinal or sub-retinal fluid with foveal involvement
* Chronic renal failure
* History of liver or pancreatic transplant
Accelerated Tooth Movement With AcceleDent® and Aligners - a Pilot Project

The AcceleDent® device has been introduced to the specialty of orthodontics in order to reduce treatment time. The theory behind AcceleDent® is that high frequency vibratory forces (30Hz) delivered to the teeth will stimulate the bone remodeling that is necessary for tooth movement to occur more quickly.

Additionally, one claim of the AcceleDent® product is that it may reduce pain and discomfort during orthodontic treatment.

This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.

This study will be a parallel group, triple-blind randomized clinical trial comparing two groups of subjects with 12 participants in each group. Subjects will be randomized to receive one of two vibrational units, which will differ in frequency and/or amplitude of vibration. The subjects will be asked to change their aligners every week instead of every 2 weeks, which is common with Invisalign.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with malocclusions that require minor or no anterior-posterior or transverse correction in the posterior teeth, and are planned for \<= 25 aligners to complete treatment.
2. Treatment must be dual arch in order for patients to qualify for this study.
3. Patients must be 18 years or older

Exclusion Criteria:

1. Patients with systematic diseases or syndromes
2. Patients with a history or current use of Bisphosphonates
3. Patients with current use of nonsteroidal anti-inflammatory drugs (NSAIDs)prostaglandin inhibitors.
4. Patients with generalized moderate to severe periodontitis
5. Patients with active oral hard tissue or soft tissue lesions
6. Patients with chronic oral and maxillofacial conditions such as trigeminal neuralgia, temporomandibular disorder and orofacial pain.
Safety and Efficacy Study of Altabax Ointment in the Treatment of Secondarily Infected Atopic Dermatitis

Skin infections may complicate the treatment of atopic dermatitis.The use of topical ointments has become very important to avoid the use of oral antibiotics. There is little supporting literature regarding the use of topical antibiotics in secondarily infected atopic dermatitis.

This study will investigate the safety and effectiveness of Altabax ointment use in treating secondarily infected atopic dermatitis caused by Staphylococcus aureus and Streptococcus pyogenes.

Atopic dermatitis patients are commonly secondarily infected with Staphylococcus aureus and/or Streptococcus pyogenes, more recently with Methicillin-resistant Staphylococcus aureus (MRSA), due to impaired barrier function. As cutaneous infections such as MRSA and others may complicate the treatment of atopic dermatitis, the use of topical antibiotics have become very important to avoid oral antibiotics and their side effects, especially in the pediatric population.

The current study will investigate the safety and efficacy of Altabax ointment use for treatment of secondarily infected lesions caused by Staphylococcus aureus and Streptococcus pyogenes in both the pediatric and adult populations.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception.
* Secondary infection of atopic dermatitis with S.aureus or S.pyogenes as the probable causative agent.
* An infected area less than or equal to 100 centimeters squared for subjects 18 years of age or older, or, 2% body surface area for subjects under 18 years of age.
* Skin Infection Rating Scale score greater than or equal to 8.
* Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization Forms. Subjects under the legal age of consent must also have the written informed consent of parent or legal guardian.

Exclusion Criteria:

* Female subjects who are pregnant, trying to get pregnant, breast feeding or who are of childbearing potential and not practicing reliable birth control.
* Allergic to any component of the test medication.
* Clinical diagnosis of impetigo, folliculitis or minor soft tissue infection.
* Use of topical antibacterial medication to the study treatment area within 1 day of Visit 1.
* Signs of systemic infection or evidence of abcess or cellulitis at the site to be treated.
* Medical condition that,in the opinion of the investigator, contraindicates the subject's participation in the clinical study.
* Recent alcohol or drug abuse is evident.
* History of poor cooperation, non-compliance with medical treatment or unreliability.
* Participation in an investigational drug study within 30 days of Baseline Visit.
MRI Assessment of Arrythmia Ablation Lesions

This study will evaluate the feasibility of visualization and characterization of arrhythmia ablation lesions by MRI immediately following standard ablation techniques. The appearance of the ablation lesion will be correlated with clinical outcomes and risk of arrhythmia recurrence.

Children's National Heart Institute (CNHI) with major contractual support from the National Institutes of Health / National Heart, Lung and Blood Institute has installed a combined X-ray / Magnetic Resonance Imaging cardiac catheterization lab suite allowing for experts in the fields of cardiac MRI, interventional cardiac MRI and clinical pediatric interventional electrophysiology to work together to make substantial advancements in the development of novel techniques and applications to reach the goal of improved survival and care for the congenital heart disease population. The CNHI X-ray/MRI suite will allow for streamlined transfer of patients from fluoroscopy directly to the MRI scanner under the same sedation thereby allowing for immediate post procedure imaging and minimizing risk to the patient.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from any patient willing to participate who is undergoing an electrophysiology study with potential for arrhythmia ablation
* Written informed assent, if applicable

Exclusion Criteria:

* Women who are pregnant
* Women who are nursing and who do not plan to discard breast milk for 24 hours
* Patients with a contraindication to MRI scanning will be excluded. These contraindications include patients with the following devices:

  * Central nervous system aneurysm clips
  * Implanted neural stimulator
  * Implanted cardiac pacemaker or defibrillator which are not MR safe or MR conditional according to the manufacturer
  * Cochlear implant
  * Ocular foreign body (e.g. metal shavings)
  * Implanted Insulin pump
  * Metal shrapnel or bullet.
  * Any intracardiac or intravascular device that is not MR safe or MR conditional according to the manufacturer based on both material and timing of device placement
Surveying Knowledge, Attitudes, and Practices of Primary Care Physicians in Turkey Regarding Osteoporosis Management.

This study aims to assess the knowledge of primary care physicians on the diagnosis and treatment of osteoporosis.

Multiple choice questions will be used to assess information related to the diagnosis and treatment of osteoporosis, including knowledge of various medications, their mechanisms of action and side effects, and recommended dosage of vitamin D supplementation. The participating physicians will also be asked about their sources of knowledge acquisition and how they keep updated on this topic, as well as their self-evaluation of knowledge. Furthermore, background information will be collected, including professional and demographic characteristics. A questionnaire previously used in other studies will be adapted for the study based on the 'Updated approach for the management of osteoporosis in Turkey: a consensus report'.

Eligibility Criteria:
Inclusion Criteria:

* Giving consent.
* Working as a family physician assistant, family physician specialist or general practitioner in Turkey.

Exclusion Criteria:

* Not giving consent.
* Having any physical or mental illness that may prevent reading, understanding and filling out the form.
Maca in Healthy Subjects After Strenuous Endurance Exercise

The aim of this study is to investigate Lepidium meyenii (Maca) extract supplementation on exercise-induced responses of the biochemical, and physiological parameters.

Thirty healthy male participants were divided into Maca group (2.25 g of Maca extract, twice per day for 12 weeks) and placebo group (n = 15). All participants conducted a graded exercise test on treadmill to determine the maximal oxygen consumption (VO2max) before and after supplementation, and the speed equivalent to 70% VO2max was conducted for an exhaustive endurance exercise test by treadmill for 1 hours, followed by 90% VO2max until exhaustion.The time to exhaustion, peak oxygen consumption, maximal heart rate and average heart rate will be recorded during the exercise period. Venous blood samples will be drawn before, immediately after, 2-hour after, 4-hour after, and 24-hour after the exhaustive endurance exercise test. Data was analyzed by Two-way mixed design ANOVA.

Eligibility Criteria:
Inclusion Criteria:

-

The volunteers included have conditions as stated below :

1. male adult whose no history of cardiovascular, liver, kidney and diabetes disease
2. no acute sport injury
3. did not participated in any clinical trials or research in the last 3 months before our experiment
4. no supplements were taken during the experimental period
5. were requested to maintain their regular daily life style and avoid alcohol intake

Exclusion Criteria:

-

The volunteers were excluded if they have the situation stated below:

1. history of cardiovascular, liver, kidney and diabetes disease
2. acute sport injury
3. participated in any clinical trials or experimental research in the last 3 months before our experiment
4. taking supplement during the experimental period
5. did not maintain their regular eating habit or drink alcohol
The Effect of Brain Anatomy on the Efficacy of Brain Stimulation Therapy

The purpose of this research study is to determine whether brain anatomy impacts the efficacy of transcranial magnetic stimulation (TMS) which is a form of non-invasive brain stimulation. TMS is used to stimulate different areas of the brain and it is well tolerated and generally a safe procedure. It has been studied by researchers for 20 plus years. This brain stimulation device and technique used in this study is an investigational device that has not been approved by the U.S. FDA for treating any muscle or nerve problems. A copy of the device brochure can be found at: https://www.magstim.com/product/rapid-family/


Eligibility Criteria:
Inclusion Criteria:

* nonimpaired individuals
* free of contraindications for MRI and TMS

Exclusion Criteria:

* musculoskeletal injury of the arm
* neurologic deficit affecting motor or sensory function
* concurrent severe medical illness
* diagnosis of SARS-CoV2, or symptoms consistent with COVID-19, or close contact with someone with SARS-CoV2 in the past 3 weeks
Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation

This is a retrospective review of the COLTT program outcomes and factors that predict recovery of functional status after lung transplantation.

The Center of Life for Thoracic Transplant (COLTT) program is a daily (5 days per week) intensive rehabilitation program for patients who have undergone lung transplant. Patients are enrolled in COLTT as part of standard care after hospital discharge. This study is a retrospective review of seventy patients that measures the efficacy of the COLTT program and establishes predictors of patient success.This study will also measure the effect of functional outcomes on hospital readmission post COLTT discharge.

Eligibility Criteria:
Inclusion Criteria:

* All patients who completed the COLTT program from May, 2016 to July, 2017.

Exclusion Criteria:

* Any COLTT patients who were not new lung transplant recipients.