cyrilzakka/clinical-trials huggingface dataset:
National Study on the Quality of Life of Patients With Anorectal Malformation

Anorectal malformations, occurring approximately 1 in 5000 live births, mainly involve the distal anus and rectum, but also sometimes the urinary and genital tracts. Defects range from the minor and easily treated with an excellent functional prognosis, to those that are complex and often associated with a poor functional prognosis.

Despite the better knowledge of the anatomy and physiology and the improvement of surgical management after birth, fecal and urinary incontinence can occur, due mainly to deficient nerve supply.

The quality of life of such patients is largely unknown in this country. The aim of the investigators study is to propose specific and generic questionnaires to the patients registered in the national database, correlated to their anatomical and functional status. A better understanding of such correlations should allow improvements in their medical and social management.

Anorectal malformations (ARM), occurring approximately 1 in 5000 live births, mainly involve the distal anus and rectum, but also sometimes the urinary and genital tracts. Defects range from the minor and easily treated with an excellent functional prognosis, to those that are complex and often associated with a poor functional prognosis. Despite the better knowledge of the anatomy and physiology and the improvement of surgical management after birth, fecal and urinary incontinence can occur, due mainly to deficient nerve supply. A few studies and clinical practice have shown that disease-specific problems of ARM have an effect on somatic function, mental health and psychosocial functioning.

The assessment of quality of life requires a self-report questionnaire composed of items related to physical, emotional and social functioning, and disease-related symptoms. A specific ARM questionnaire, the HAQL, was developed by a Dutch team and published in 2001. Associated with generic questionnaire, it allowed quality of life assessment in Dutch population.

The quality of life of such patients is largely unknown in this larger country. The aim of the investigators study is to propose specific (HAQL translated from Dutch to French) and generic questionnaires to the patients registered in the national database, correlated to their anatomical and functional status.

A better understanding of such correlations should allow improvements in their medical and social management.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are between 6 and 30 years old
* Patients initially treated in a french pediatric surgery service for anorectal malformation

Exclusion Criteria:

* Patients lost from sight or dead
* Patients with concomitant malformations that can modify sphincter functions besides anorectal malformation (spina bifida, )
* Patients whose brain functions do not allow to reply to a questionnaire (mental retardation)
The Use of an Inhaled Salt Solution to Treat Viral Lung Infections in Infants.

Bronchiolitis is a common viral lung infection in infants. Standard treatment often includes the use of inhaled medications which are usually first mixed with a standard salt solution. Inhalation of a more concentrated salt solution (hypertonic saline) has been successfully used to treat other types of lung disease in children and adults. The purpose of this study is to see if using inhaled hypertonic saline helps infants with bronchiolitis get better more quickly.

Bronchiolitis is a common illness in infants and is associated with a significant morbidity. Standard therapy is controversial and largely ineffective; care is mostly supportive although nebulized medications continue to be commonly used. These medications are typically mixed with normal saline to produce a sufficient volume for efficient nebulization.

Inhaled hypertonic saline has been used to aid airway clearance in children with cystic fibrosis. It has also been used, in low dose, in two small studies in children with bronchiolitis. The current study is a randomized, double-blind, placebo-controlled, multi-center trial comparing frequent dosing with 3% hypertonic saline compared to normal saline in the treatment of infants hospitalized with bronchiolitis.

Eligibility Criteria:
Inclusion Criteria:

* Corrected age maximum 18 months, plus
* History of preceding viral upper respiratory tract infection, plus
* Presence of wheezing and/or crackles on auscultation, plus
* Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater, or oxygen saturation of 93% or less in room air, plus
* Admitted to hospital

Exclusion Criteria:

* Prior history of wheezing, or
* History of chronic cardiopulmonary disease or immunodeficiency, or
* Critical illness at presentation requiring admission to ICU, or
* Use of nebulized hypertonic saline within previous 12 hours, or
* Prematurity (gestational age 34 weeks or less).
Immediate Effect of Irradiation With Low-level Laser Therapy on the Electromyographic Activity of the Upper Trapezius Muscles and the Level of Pain Among Patients With Non-specific Neck Pain

The aim of the present study is to assess the immediate effect of irradiation with low level laser therapy (LLLT) on the electromyographic activity of upper trapezius muscles and the amount of pain felt by patients with non-specific neck pain (NS-NP).A total of 20 patients with non-specific neck pain will be enrolled in a randomized, single-blind, crossover study. Each subject will receive two forms of treatment in random order: a single session of LLLT and placebo LLLT. In order to eliminate carry-over treatment effects, a one-week wash-out period will be respected between sessions. Surface electromyography will be used to determine nerve conduction velocity and activity in the upper trapezius muscles before and after treatment. The outcome measures will be determined by a numerical pain rating scale. Comparisons before and after irradiation with LLLT will determine the activity of the upper trapezius muscles and the level of pain. The data will be submitted to statistical tests considering a p-value of p \< 0.05.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 40 years
* Male and female volunteers
* History of neck pain for a period of more than two months
* Score ranging from 15 to 24 on the Neck Disability Index
* Score ranging from three to seven points on an 11-point (range: 0 to 10) numerical rating scale (NRS) for perceived pain intensity

Exclusion Criteria:

* history of neurological disorders
* neck surgery
* chronic neck pain resulting from a traumatic incident
* chronic musculoskeletal condition
* medical diagnosis of fibromyalgia; systemic disease
* connective tissue disorder
* having undergone physical therapy use of analgesic, muscle relaxant.
A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair

This is a research study testing SABER-Bupivacaine (an experimental pain-relieving medication). SABER-Bupivacaine is designed to continuously deliver bupivacaine, a common local anesthetic, for a few days in order to treat local post-surgical pain. This study is testing SABER-Bupivacaine in people having surgery to repair a hernia.

The purpose of the study is to measure and compare the safety (side effects), tolerability (ability to tolerate), and efficacy (how well it works) of two different volumes of SABER-Bupivacaine with SABER-Placebo.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 to 65 years of age, scheduled for hernia repair surgery
* Patients must be in good health prior to study participation
* Patients must have blood pressure within normal range or with Stage 1 high blood pressure
* Male and female patients must agree to use medically acceptable method of contraception throughout the entire trial period and for 1 week after the trial is completed
* Patients must refrain from strenuous activities and avoid changes to prescribed exercise levels throughout the course of the trial
* Ability to read, understand, communicate, and voluntarily sign the informed consent form prior to any trial specific procedures

Exclusion Criteria:

* Patients with previous abdominal surgery scar tissue
* Patients with clinically significant abnormalities of any body system unrelated to the disease under study
* Connective tissue disorders
* Patients who are pregnant or lactating
* Current or regular use of analgesic medication for other indications
* Patients with current or regular use of antidepressants or monoamine oxidase inhibitors at screening
* Use of any drugs or medication that may interfere with the study and its results
* Patients with known hypersensitivity to the study drugs or their components
* Patients with known or suspected alcohol abuse or illicit drug use
* Participation in another clinical trial at the same time or within 30 days of this trial
* Patient is unwilling to comply with the study procedures
Low Dose Bupivacaine Spinal for Trans Uretral Prostatectomy.

Spinal anesthesia, is used during the transuretheral resection of the prostate.Low dose hyperbaric local anesthetics have been used to enhance the resolution of the spinal block. We compared the efficacy and duration of the spinal block with two different bupivacaine baricities.

* Group I: low dose isobaric group
* GroupII: Low dose hyperbaric group

Patients undergoing TURP were randomly allocated into two groups.

* Group I: Received fentanyl 20 µgr (0.4ml),heavy bupivacaine 0.5% (1.5 ml)and normal saline % 0.9 NaCl ( 1.1ml)
* Group II: Received fentanyl 20 µgr (0.4 ml), plain bupivacaine 0.5%(1.5 ml) normal saline 0.9% NaCl (1.1 mL) in total bupivacaine 0.25% (3ml) intrathecally.

Onset and duration of the sensory block, the degree of the motor block, side - effects and perioperative analgesic requirement assesed.

Eligibility Criteria:
Inclusion Criteria:

* 50-85 years ASA 1-4 BENİGN PROSTAT HYPERPLASİ

Exclusion Criteria:

* Allergy of study drugs
* Morbid obesity
* Spinal anesthesia contrindications
* Bleeding dyscrasias
Application of Ectoine Containing Nasal Spray and Eye Drops in Patients With Allergic Rhinitis

This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin Allergy Nasal Spray and Eye drops. In addition the effectiveness and safety shall be compared to Azelastine containing nasal Sprays and Eye drops. The patient applied Ectoin® Rhinitis Nasal Spray / Eye drops or takes Azelastine nasals spray and eye drops according to the instructions for use. The observation takes place over a period of 7 days. Response to treatment is recorded at day 7 by the physician and in daily by the patient in a dairy.


Eligibility Criteria:
Inclusion Criteria:

* male or female patients
* aged 18-70 years
* Patients with proven allergy and acute symptoms in nose and eye which are treated with Ectoin Allergy Nasal Spray and Ectoin Allergy Eye Drops or Azelastine Nasal Spray and Azelastine Eye Drops during the observational period

Exclusion Criteria:

* pregnancy and nursing women,
* drug addicts and persons unable to give consent to study participation,
* patients with intolerance against ingredients of any of the study treatments,
* previous eye or nose surgery,
* concomitant treatment with anti-allergic drugs, and
* diseases which might influence the output of the study according to the physicians' judgment.
* contra indications according to the label
Pacing for Heart Failure With Preserved Ejection Fraction

The purpose of this research study is to evaluate the safety of a new pacing method (Fusion Pacing) for heart failure patients with an ejection fraction (EF) greater than 50% over a period of 4 months, and determine the effects on different measures of heart failure. This new pacing method may allow the heart to pump more efficiently. Participation in this study will last approximately 8 months.

Patients with an EF greater than 50% and a regional mechanical delay of \>= 65ms (an indication of mechanical dyssynchrony) will receive an implantable cardioverter defibrillator (ICD) with a special pacing feature. When the feature is active, the device wil pace the left ventricle to target improved pump efficiency. Patients will have the feature active for 4 months and inactive for 4 months. The order will be randomized and the patient will not know whether the pacing is active or not. Echocardiography, biomarkers, exercise testing, quality of life (QOL) testing and device information will be used to compare the patient's status while the feature is active vs. inactive.

Eligibility Criteria:
Inclusion Criteria:

* Patients with quantitative ejection fraction (EF) of greater than 50 percent
* Patients with active heart failure (symptomatic American Heart Association/American College of Cardiology stage C) despite optimal medications
* Patients greater than 18 years of age
* Patients willing and able to give informed consent
* Patients available for appropriate follow-up times for the length of study
* Patients able to complete cardiopulmonary exercise (CPX) testing
* Patients expected lifespan is greater than 12 months beyond study enrollment
* Patients with a regional mechanical delay (RMD) (septal-lateral) greater than 65 milliseconds

Exclusion Criteria:

* Patients who have undergone cardiac surgery 60 days prior to enrollment
* Patients who have had a myocardial infarction 90 days prior to enrollment
* Patients with hemodynamically significant uncorrected cardiac valvular disease
* Patients with active myocarditis and amyloidosis (if documented)
* Patients with a permanent pacemaker
* Patients with creatinine greater than 2 milligrams per milliliter or estimated glomerular filtration rate (eGFR) less than 30 to 50 milliliters per hour
* Patients with permanent or chronic sustained atrial fibrillation (fibrillation lasting 7 days or more at a time)
* Patients with a PR interval greater than 250 milliseconds
* Patients with severe chronic obstructive pulmonary disease
* Patients with high risk coronary artery disease
* Patients who are or expect to become pregnant during this study
* Patients enrolled in concurrent studies which could confound the results of this study
* Patients with hypertrophic cardiomyopathy (obstructive or non-obstructive)
* Patients with infiltrative disease or restrictive cardiomyopathy
* Patients with indication for percutaneous coronary intervention (PCI) at enrollment
A Prospective Study Evaluating the Performance of Nanotite Osseotite Implants When Placed by Graduate Student Programs

This study will evaluate the contributions of the Nanotite implant design when used by graduate students in their first year of placing implants.

This multicenter, prospective, randomized-controlled study will compare the performance of the Nanotite vs. the standard Ossotite implants when placed by graduate students with little or no prior experience. Enrolled patients will have the study site(s) randomized to either a Nanotite (test) or an Osseotite (control) implant. The manner of treatment observed at the participating center will be followed for this study.

Study Hypothesis: The performance of the Nanotite implant in this study will be no different than or superior to that of the Osseotite implant placed during the early period of graduate student training.

Eligibility Criteria:
Inclusion Criteria:

* patients of either sex and of any race, 18 years of age or older
* patients for whom a decision has already been made to use dental implants for treating edentulism in the mandible or maxilla

Exclusion Criteria:

* patients who are known to be pregnant
Study of ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung Disease

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ARO-MUC5AC in normal healthy volunteers (NHVs), patients with moderate-to-severe asthma and patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In part 1 NHVs will receive a single dose of ARO-MUC5AC or placebo. In part 2 of the study, NHVs, adult patients with asthma, and adult patients with COPD will receive 3 doses of ARO-MUC5AC or placebo.


Eligibility Criteria:
Inclusion Criteria:

* Normal pulmonary function tests at Screening (NHVs only)
* Confirmed diagnosis of asthma or COPD based on source verifiable medical record (asthma and COPD patients only)
* No abnormal finding of clinical relevance at Screening (NHVs only)
* Stable dose of asthma controller medications for at least 28 days prior to Screening (asthma patients only)
* Documented treatment with an inhaled corticosteroid and at least 1 additional maintenance asthma controller medication for at least 3 months prior to Screening (asthma patients only)
* Non-smoking (NHVs and asthma patients)
* Current smoker or ex-smoker with smoking history of ≥ 10 pack-years (COPD patients only)
* All COPD treatments have been stable for at least one month prior to Screening (COPD patients only)
* Able to produce an induced sputum sample at Screening
* Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. Males must not donate sperm during the study and for at least 90 days following the last dose of study drug
* Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

* Acute lower respiratory infection within 30 days prior to first dose and/or acute upper respiratory infection within 7 days prior to first dose
* Positive COVID-19 test during Screening window
* Any history of chronic pulmonary disease (NHVs only)
* Any concomitant pulmonary disease in asthma or COPD patients that could interfere with the evaluation of the study drug or interpretation of patient safety or study results
* Use of theophylline within 30 days prior to first dose
* History of lung volume reduction surgery or pneumonectomy (COPD patients)
* Need for chronic oxygen support at Screening
* Clinically significant health concerns (other than asthma in asthma patients)
* Human immunodeficiency virus (HIV) infection, seropositive for hepatitis B virus (HBV), seropositive for hepatitis C virus (HCV)
* Uncontrolled hypertension
* Unwilling to limit alcohol consumption to within moderate limits for the duration of the study
* Use of illicit drugs
* Use of an investigational agent or device within 30 days prior to first dose

Note: additional inclusion/exclusion criteria may apply per protocol
Hyaluronic Acid Injection in the Glans Penis Versus Selective Serotonin Reuptake Inhibitors for Lifelong Premature

The aim of this study was to compare the effectiveness and safety of selective serotonin reuptake inhibitors (dapoxetine) and hyaluronic acid gel injection in the glans penis for lifelong premature.

Over the past 30 years, the common knowledge of Premature ejaculation (PE) has advanced strikingly. PE is a very common and upsetting sexual male dysfunction. It is disturbing for both partners affecting their sexual experience, reducing their quality of life up to sexual abstinence, causing lack of self-confidence and even depression. It has a prevalence of a variable range, yet it is thought that one third of all males might complain of PE at a certain point throughout their lives and the incidence is rising.

Many treatment modalities have been currently used for PE varying from behavioral therapy to medical treatment and finally surgical therapy. Methods of behavioral therapy are: Squeeze technique and Start/stop technique. Pharmacological therapies include: nonselective and selective SSRIs, topical therapy with anesthetics, PDE5 inhibitors, opioid agonists and others. As for surgical modalities for PE there are several techniques including: glans augmentation, frenectomy, dorsal selective neurectomy, pulsed radiofrequency neuromodulation, removal of foreskin remnants and varicocelectomy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* Males.
* Suffering from lifelong premature ejaculation not responding to the behavioral therapy.

Exclusion Criteria:

* Erectile dysfunction.
* Prostatitis.
* Acquired premature ejaculation.
* Addiction.
* Psychiatric disorders (e.g., schizophrenia, bipolar disorder, and other psychoses).
* Historical use of ejaculatory medication within the previous three months.
RDS MultiSense® SpO2 Calibration

Data will be collected with the MultiSense® pulse oximetry system during non-motion conditions over the range of 70-100%. A Clinimark reference system, previously correlated to arterial blood CO-Oximetry will be the basis for comparison. A minimum of fifteen (15) up to fifty (50) healthy adult subjects, ranging in pigmentation from light to dark, with at least six (6) subjects with dark pigmentation (Fitzpatrick 5-6), will be enrolled in the study to meet the study design requirements defined by ISO 80601-2-61 and by the FDA's Guidance for Pulse Oximeters (March 4, 2013). SpO2 data will be evaluated during non-motion conditions. SpO2 data will be evaluated during stable step plateaus of induced hypoxic levels. The investigational device will be placed on the thorax of the subjects (patch on the upper back and external electrode on the right pectoral). Simultaneous data collection will be set up for the reference and the systems under test.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have the ability to understand and provide written informed consent
* Subject is 18 to 50 years of age
* Subject must be willing and able to comply with study procedures and duration
* Subject is a non-smoker or who has not smoked within 2 days prior to the study.
* Male or female of any race
* Subject demographics include a range of skin pigmentations, including at least 3 darkly pigmented subjects or 15% of the subject pool, whichever is larger.

Exclusion Criteria:

* Subject is considered as being morbidly obese (defined as BMI \>39.5)
* Compromised circulation, injury, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites, tattoo in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow subjects to participate if the condition is noted and would not affect the particular sites utilized.)
* Females who are pregnant, who are trying to get pregnant, (confirmed by positive urine pregnancy test unless the subject is known to be not of child-bearing potential)
* Subjects who have smoked in the last 2 days with COHb levels \>3% as assessed with a Masimo Radical 7 (Rainbow)
* Subjects with known respiratory conditions (self-reported)
* Subjects with known heart or cardiovascular conditions (self-reported, except for blood pressure and ECG review) or with an implantable active medical device such as pacemaker or automatic defibrillator
* Self-reported health conditions as identified in the Health Assessment Form (self-reported)
* Subjects with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
* Unwillingness or inability to remove colored nail polish from test digits.
* Unwillingness to have chest or other test site shaved
* Other known health condition, should be considered upon disclosure in health assessment form