cyrilzakka/clinical-trials huggingface dataset:
Comparison of the Effect on the Glucose Infusion Rates Between Inhaled Technosphere Insulin and a Subcutaneous Injection of Regular Human Insulin

A prospective, single center, open randomized, six way crossover study comparing the dose response effect of four different doses of Technosphere Insulin after pulmonary function delivery in comparison to s.c. injection of two different doses of regular human insulin.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be in good health, as judge by brief history and physical examination.
* Sex: both, male and female.
* Age: 18-40 years.
* Body mass index: 18-27 kg/m2.
* Capability to reach peak inspiratory flow of \>41/sec measured by a computer assisted spirometry.
* FEV1 equal to or greater than 80% of predicted normal.

Exclusion Criteria:

* Diabetes Mellitus type 1 or type 2.
* Human insulin antibodies.
* Anamnestic history of hypersensitivity to the study medication or to drugs with similar chemical structures.
* Having a history of severe or multiple allergies.
* Treatment with any other investigational drug in the last three months before study entry.
* Progressive fatal disease.
* History of significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and /or hematological disease.
* Having ongoing respiratory tract infection.
* Smoker defined as subjects with evidence or history of tobacco or nicotine use in the last year prior to entry in the study.
* Blood donation within the last 30 days.
* A woman who is lactating.
* Pregnant women or women intending to become pregnant during the study.
* A sexually active woman of childbearing age not actively practicing birth control or using medically accepted device or therapy.
* A lack of compliance or other reasons, which prevent to the opinion of the investigator the participation of the subject in the study.
Study to Compare Marginal Bone Loss Around Implants From Two Dental Implant Systems.

The purpose of this study is to compare marginal bone level changes between ASTRA TECH Implant System; Fixture ST and Biomet 3i; Osseotite® Implants. Subjects with partial edentulism in the posterior maxilla and/or mandible will be included and a one-stage surgical protocol will be used. Implants will be loaded within 15 weeks from installation. The subjects will be followed for 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent
* Age 18 - 75 years
* Partial edentulism, Kennedy class I or II, last natural tooth must be cuspid or first bicuspid
* Edentulous in the area/s if implant placement for more than 2 months

Exclusion Criteria:

* Untreated caries and/or periodontal disease of residual dentition
* Need for pre-surgical bone or soft tissue augmentation in the planned implant area/s.
* Absence of occlusal stability in centric occlusion
* Any systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
* Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration
* Pregnancy
* Present alcohol or drug abuse
* Tobacco smoking during the last 6 months
* Unable or unwilling to return for follow-up visits for a period of 3 years
A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.


Eligibility Criteria:
Inclusion Criteria:

Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS.

Exclusion Criteria:

Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.
Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?

To evaluate the efficacy and safety of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing urethral stricture recurrence after direct visual internal urethrotomy.

The most common aetiology of urethral strictures is idiopathic, followed by iatrogenic causes, including transurethral resection, urethral catheterization, prostate cancer treatments, and previous hypospadias surgery.

The recurrence rates are higher with previously treated, long and multiple strictures, penile compared with bulbar strictures, and those with perioperative infection.

It has been reported that post-transurethral resection of the prostate (TURP) to receive or not receive a COX-2 inhibitor (rofecoxib 25 mg/day) for 20 days. At 1 year of follow-up, a urethral stricture had been diagnosed in 17 and 0 % of cases without and with COX-2 treatment, respectively

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* American Society of Anesthesiologists (ASA) score ≤3.
* Urethral stricture length ≤ 1.5 cm

Exclusion Criteria:

* Recurrent urethral stricture ≥ 2 times.
* Pelvic fracture urethral distraction defect (PFUDD).
Study of Evaluation Indexes for Antibody Production in Sera After Immunization

The aim of this study is to evaluate analytical methods such as ELISA and OPKA that measure the activity of vaccine-induced pneumococcal antibodies. After validation of ELISA and OPKA, pneumococcal antibodies were measured by ELISA and OPKA in paired samples before and after immunization (pneumococcal PS vaccine) in children, adults and elderly.

To evaluate the immune response to the pneumococcal polysaccharide vaccine in the elderly, samples from children, young adults and elderly were obtained before and one month after vaccination. The quantitative and qualitative response to the vaccine were measured by the ELISA and opsonophagocytic killing assay for eight vaccine type serotypes (4, 6B, 9V, 14, 18C, 19A, 19F, 23F) and one vaccine-related serotype (6A).

Eligibility Criteria:
Inclusion Criteria:

* elderly subjects over the age 65 years who had not received pneumococcal vaccination
* adult subjects under the age of 45 years (healthy volunteers with no previous history of pneumococcal vaccination)
* children subjects over the age of 2 years with no previous history of pneumococcal vaccination

Exclusion Criteria:

* immunocompromised, asplenia, cancer, liver or renal failure, and history of hypersensitivity to vaccine
Under-Represented Communities Diagnosed With SCD or MCI Through Tele-Cog

Overall, this study's primary aim is to establish a prospective, longitudinal, observational cohort study of older adults at risk for dementia from under-resourced/underrepresented communities. More specifically, older adults diagnosed with subjective cognitive decline (SCD) or Mild Cognitive Impairment (MCI) during clinical care offered via the Tele-Cog clinic would be recruited for more comprehensive data collection to characterize the clinical presentation and course of illness over multiple timepoints spread out longitudinally.

Clinical data obtained as part of standard of care will be collected from the medical record (including clinical diagnosis, cognitive and other neuropsychological test scores, lab results, neuroimaging data, etc.) and additional data (neuropsychological test batteries and clinical questionnaires if not already obtained) would be obtained at research study visits.

Participants will be asked to participate in annual research visits for up to 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ages 50 years and older
2. Diagnosed with subjective cognitive concerns (SCD) or objective cognitive decline with mostly intact functioning (MCI diagnosis) as part of clinical work up
3. Fluent in English
4. Able to provide voluntary informed consent
5. Willing and able to undergo all study procedures
6. Able to delegate, if possible, a study partner to contribute information regarding daily activities and cognition

Exclusion Criteria:

1. Diagnosis of dementia at baseline.
2. Inability to give informed consent.
3. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).
B-type Natriuretic Peptide (BNP) in Human Hypertension

The investigators working hypothesis is that human hypertension is in part due to a derangement in the endocrine function of the heart - a primary or secondary mechanism - resulting in a relative deficiency of the natriuretic peptides (NP). The remodeled hypertensive heart could result in altered processing and degradation of B-type NP resulting in altered molecular forms with decreased biological activity. The investigators further hypothesized the chronic administration of BNP in subjects with hypertension, is feasible, safe and will induce a sustained reduction in blood pressure.

Ongoing investigations by our laboratory group and others have established that the heart is an endocrine organ as well as a pump. The heart synthesizes and secretes two peptide hormones - atrial natriuretic peptide (ANP) and B-type natriuretic peptide (BNP) - that are endogenous ligands for a particulate guanylyl cyclase receptor (NPR-A). Following receptor binding and generation of its second messenger cGMP, the natriuretic peptides (NPs) mediate biological actions which include natriuresis, inhibition of the renin-angiotensin system and vasodilatation with local autocrine and paracrine actions in the heart to include inhibition of fibrosis and enhancement of diastolic function.

Hypertension remains a global burden in cardiovascular disease leading to stroke, myocardial infarction and heart failure. Its myocardial complications result from increased mechanical load on the heart. Under physiological conditions of increased myocardial load and resulting myocardial stretch, ANP and BNP synthesis and secretion occur contributing to maintenance of optimal cardiorenal and blood pressure homeostasis.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Subjects with stage 1 hypertension (SBP: 140-159 mm Hg or DBP 90-99 mm Hg) If on therapy, it must be stable for at least 1 month.

Exclusion Criteria:

* Congestive Heart Failure (any NYHA class).
* EF \< 50%.
* Myocardial infarction within 3 months of screening.
* Unstable angina within 14 days of screening, or any evidence of myocardial ischemia.
* Moderate to severe pulmonary hypertension.
* Valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis.
* Sustained VT or V-fib within 14 days of screening.
* Sustained Atrial Fibrillation.
* Second or third degree AV block without a permanent cardiac pacemaker.
* CVA within 3 months of screening, or other evidence of significantly compromised CNS perfusion.
* Total bilirubin of \>1.5 mg/dL or AST and ALT 1.5 times the upper limit of normal range.
* Renal insufficiency assessed by calculated GFR \< 60 ml/min (Cockroft-Gault equation).
* Serum sodium of \< 125 mEq/dL or \> 160 mEq/dL.
* Serum potassium of \< 3.5 mEq/dL or \> 5.0 mEq/dL.
* Women taking hormonal contraceptives.
* Body Mass Index (BMI) \> 35.
Pelvic Floor Muscle Training With Leva System for Urge Incontinence

This is a pilot non-comparative study to assess the effectiveness of pelvic floor muscle training guided by the leva® system for improving change in subject-reported incontinence-related quality of life and urgency urinary incontinence (UUI) episode frequency based on voiding diaries in women at 8 weeks.

Our study aims to investigate a new alternative to formal pelvic floor physical therapy that may provide subjects with a more accessible, private method of undergoing pelvic floor muscle training (PFMT) with real-time biofeedback on performance. The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes. We hypothesize that women using the leva® System will experience significant improvements in subjective urge-related incontinence symptoms. In addition, changes in incontinence-related quality of life and UUI episode frequency will be determined.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years old
* Urinary incontinence for ≥ 3 months
* Reporting at least "moderate bother" on Item 2 on the UDI-6, "Do you experience urine leakage in related to the feeling of urgency" (on new patient paperwork)
* If mixed urinary incontinence, Medical Epidemiologic Social Aspect of Aging Urinary Incontinence Questionnaire (MESA) score indicating urge-predominant MUI (Urge subscale % \> Stress subscale %)
* Presence of ≥ 1 UUI episode on 3-d bladder diary (see Appendix 2)
* Is the baseline bladder diary consistent with the patient's typical habits?
* Not currently taking anti-muscarinic or beta3 agonist therapy (after at least 2 week wash-out period)
* Brink Score \> 3 (see below)
* Access to smartphone technology, including iOS or Android™

Exclusion Criteria:

* Non-English speakers
* Severely impaired mobility or cognition
* Spinal cord injury or advanced/severe neurologic condition including Multiple Sclerosis, Parkinson's Disease
* Concomitant prolapse beyond the hymen or repair of prolapse in the previous 6 months
* Received intravesical botulinum injection within the previous 12 months
* History of implanted nerve stimulator for incontinence
* History of prior sling or vaginal mesh placement
* Previous diagnosis of Interstitial cystitis
* Active pelvic organ malignancy
* History of pelvic radiation
* Urethral obstruction
* Urinary retention or prolonged catheter use
* Less than 12 months post-partum are currently pregnant, or plan to become pregnant in the following 12 months
* Untreated symptomatic urinary tract infection
* Unevaluated hematuria
* Medical instability
* Not available for follow-up in 6 months
* Participation in other research trials that could influence results of this study
Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy

Pancreaticoduodenectomy (PD)is the treatment of choice for patients with periampullary tumour (benign or malignant). In the recent years, the mortality rate of PD has decreased to 5% in many centers. However, pancreatic fistula (POPF) still occurs in 5 % to 40% of patients after PD. The hypothesis that isolated Roux loop PJ with isolated pancreatic drainage decrease the incidence of PF and severity with preservation of pancreatic function.

So the investigators compare isolated Roux Loop Pancreaticojejunostomy (PJ) Versus Pancreaticogastrostomy (PG) as regards incidence of POPF, severity of POPF and functional outcome.

The hypothesis that isolated Roux loop PJ decrease the incidence of PF and severity with preservation of pancreatic function (exocrine and endocrine functions).

Preoperative evaluation included abdominal CT, liver function, tumor marker CEA, CA19-9, preoperative ERCP were optional in selected cases (patients with high bilirubin with high enzymes. Patients with distant metastasis or locally advanced were excluded.

Informed consent was obtained from all patients entered in the study Randomization: enrolled patients were randomized intraoperatively after PD resection to either isolated Roux PJ with isolated pancreatic drainage group or PG group by closed envelope which withdrawn by the nurse.

Operative technique. Standard PD with regional lymphadenectomy was performed. PG was done between pancreatic stump and posterior surface of the stomach with 2 layer interrupted anastomosis,and duct to mucosa.

Isolated Roux PJ group, reconstruction was begun using the transected jejunum and, which was anastomosed in end to side fashion. A separate Roux loop was performed for HJ, by dividing the jejunum about 40 cm beyond the pancreatic anastomosis and GJ was done in this loop (30 cm caudally from HJ). The PJ loop was anastomosed to the main loop (20 cm caudal to GJ).

One intrabdominal drains in morrison space. Intraoperative data and postoperative data were collected. Pancreatic function assessment.

The primary outcome was assessment the incidence of POPF after isolated Roux PJ and PG. The secondary outcomes were intraoperative blood loss, drain amount,day to resume oral intake hospital stay, operative duration, pancreatic function, postoperative complications delayed gastric emptying,

Eligibility Criteria:
Inclusion Criteria:

* All periampullary tumour either benign or resectable malignant tumour

Exclusion Criteria:

* locally advanced tumour infiltrating SMA
* Metastasis
* unfit
Xeljanz Special Investigation for Long-term Use in UC Patients

Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

This investigation aims to examine the safety and effectiveness of Xeljanz in post-marketing clinical settings when it is administered chronically to patients with ulcerative colitis, based on the approval conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ulcerative colitis treated with XELJANZ
* Patients naive to XELJANZ in the treatment of ulcerative colitis

Exclusion Criteria:

- None
Effect of a Family-Based CBT Self-Help Intervention for Adolescents With OCD

The goal of this clinical trial is to learn if self-help book can be used to treat obsessive-compulsive disorder (OCD) in adolescents aged 10 to 17. The main questions it aims to answer are:

Can adolescents and their parents effectively reduce the severity of the obsessive-compulsive symptoms in adolescents who are already stably taking medications through self-help books? What are the characteristics of adolescents who are best suited to use self-help intervention book to treat obsessive-compulsive symptoms?

Researchers will compare the use of a self-help books plus medication with medication alone to see if the combination of the self-help intervention and drug treatment can improve the obsessive-compulsive symptoms of adolescents more effectively.

Participants will:

* Read one chapter of a self-help book and complete the corresponding exercise each week for 12 weeks
* Visit the clinic before and after intervention for checkups and tests


Eligibility Criteria:
Inclusion Criteria:

1. Age between 10 and 17 years
2. Satisfied with the diagnostic criteria for OCD in DSM-5
3. 16≤CY-BOCS score ≤23
4. Taking medication stably for 6 weeks
5. Education level ⩾6 years
6. At least one parent can accompany the patients throughout the entire intervention process
7. The patient and the participating parent have sufficient reading and writing skills to complete the treatment intervention
8. The patient and the participating parent have adequate auditory and visual abilities skills to complete the necessary examinations for the study

(7) Right-handed (this criterion is for fMRI subjects only) (8) Subjects and their guardians understood the study and signed informed consent.

Exclusion Criteria:

1. Obsessive-compulsive symptoms were too severe to participate in the experiment(CY-BOCS score ≥24)
2. High risk of suicide
3. Comorbid brain organic diseases, severe somatic diseases, learning disabilities, autism spectrum disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder, severe eating disorders, or substance abuse
4. Completed a Cognitive Behavioral Therapy (CBT) course for OCD within the past 12 months.
5. An IQ lower than 80
6. Currently undergoing other psychological/physical treatments
7. Uncooperative or unable to complete treatment
8. With metal implants in the body, such as pacemakers, intracranial silver clips, metal dentures, arterial stents, arterial clips, joint metal fixation, or other metal implants, etc. (this criterion is for fMRI subjects only)
Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)

Early glaucomatous visual field changes can be missed with the routinely used Standard Automated Perimetry (SAP) and the 24-2 test pattern due to limited sampling of the central 10 degrees. While this shortcoming can be overcome with the addition of a 10-2 test, performing both tests places extra demand on the perimetric services (doubling test times) and patients.

Smart Supra Perimetry (SSP) uses a new faster algorithm that can complete both 24-2 and 10-2 test patterns in a similar time frame to a single 24-2 SAP test. This comparative study aims to determine the sensitivity and specificity (i.e. diagnostic accuracy) of SSP in identifying early glaucomatous visual field loss. A sample of 100 patients with early/suspect glaucoma will undergo SAP 24-2 and 10-2 (SITA algorithm) using Humphrey visual field perimetry and SSP 24+10-2 using Henson 9000. Eyes will be categorised into 2 groups i.e., glaucoma and non-glaucoma, on the basis of structural changes to the disc as evaluated by the clinician. The sensitivity and specificity of the SAP and SSP tests will be established along with test duration. The size and location of defects established with both the SAP and SSP strategies will also be compared.


Eligibility Criteria:
Inclusion Criteria:

* Reliable SAP visual field results (fixation loss \< 33%, false positive \< 15% and false negative \< 20%).
* Visual acuity better or equal to 0.20 logMAR.
* Spherical refractive error within -6.00 to +6.00D and cylindrical error \<2.00D
* No ocular co-morbidity likely to affect the visual field or OCT results.
* Age: 40-80 yrs

Additional inclusion criteria for glaucomatous group:

* Optic disc showing glaucomatous changes.
* SAP MD not worse than -6dB

Additional inclusion criteria non-glaucoma group:

* Normal SAP visual field data (MD, PSD, GHT within normal range)
* No evidence of glaucoma or other Ocular co-morbidity in the eye suitable for the study.

Exclusion Criteria:

Exclusion criteria glaucomatous and control groups:

• Anomalous discs, Tilted discs, myopic discs.
Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter)

This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic PAD.

The primary objective of the clinical investigation is to evaluate the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries (SFA/PA) of patients with symptomatic PAD.

The performance of the GORE® DCB Catheter is superior to a performance goal derived from literature reports of uncoated PTA balloons, measured six months after intervention.

Eligibility Criteria:
Inclusion Criteria:

* PAD patients with Rutherford Class 2 - 4
* De novo or restenotic lesions, including total occlusions of the SFA/PA
* 1 lesion which may include one or more regions of luminal narrowing ≥70% with a total combined lesion length between 30 - 150mm and a reference vessel diameter of 4 - 6mm
* 1 patent tibial or peroneal artery

Exclusion Criteria:

* Surgical or endovascular access in the Target limb/vessel within the previous 30 days
* Prior treatment of the Target lesion with PTA within 90 days or any prior treatment with drug-coated balloon
* Prior treatment of the Target vessel with stenting or bypass
* Iliac artery inflow lesions that cannot be successfully treated during the Index procedure
* Acute or subacute thrombus or arterial aneurysm in Target limb
* Severe calcification that renders the Target lesion non-dilatable
* Acute or chronic renal dysfunction (serum creatinine ≥2.5 mg/dL)