cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Upper GI Ulceration Induced by PL2200 Versus Aspirin in At-Risk Subjects

This trial is a Phase 2, randomized, controlled study to compare the degree of mucosal injury after the oral administration of an investigational product, PL2200, and a marketed 325 mg immediate-release aspirin product.

Each group will be treated with either an immediate-release aspirin tablet or PL2200 capsule at 325 mg per day for 6 weeks, and evaluated via an endoscope for any gastrointestinal injury that may have been caused by study medication.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, ≥50 and ≤75 years of age.
* No endoscopically observed baseline gastrointestinal lesions.

Exclusion Criteria:

* Baseline gastrointestinal lesions or abnormal screening/baseline laboratory parameters deemed clinically significant by the Investigator.
* Significant history of substance abuse or uncontrolled acute or chronic medical illness.
* Active H. pylori infection.
* Current use of low-dose aspirin for cardioprevention, or other ulcerogenic medications, gastroprotective, or anti-platelet agents.
* Hypersensitivity to aspirin or other NSAIDs.
Local Oestrogen Versus Placebo as Preoperative Treatment in Patients With Severe Hypospadias: Effects on Post-operative Complications

Hypospadias is a congenital abnormality of the penis that is caused by incomplete development of the anterior urethra. This pathology is one of the most common genital anomalies in paediatric urology .The incidence is reported to be 1 out of 250 live male births and is increasing regularly. The hypospadias surgeries present a high risk of post operative complications requiring re-interventions.

A great part of the post operative complications is related to imperfect healing issues. If androgen stimulation seems to be deleterious, at the opposite, oestrogen could impact positively on the skin healing process. This point leads to the hypothesis that local transcutaneous oestrogen stimulation on the ventral and dorsal penile faces decreases the number of skin healing post-operative defects.

The objective of the study is to assess the effect of oestrogen (applied once daily for 2 months prior to surgery) on the post-operative complications.


Eligibility Criteria:
Inclusion Criteria:

* Severe hypospadias with a division of the corpus spongiosum behind the midshaft of the penis and for which repair requires a urethral substitution by onlay urethroplasty.
* Subjects operated between 9 and 36 months old.
* Subjects operated in one of the departments of paediatric urology involved in the study.
* Surgery performed by a surgeon with at least 5 years of practical experience in the hypospadias surgery.
* Written informed consent obtained from parents or legal guardians prior to the participation to the study
* All hypospadias aetiology (hormonal, karyotype or genetic)

Exclusion Criteria:

* Refusal to participate
* Subjects with glandular hypospadias
* Subjects aged \<9 months or \> 36months old at time of surgery.
* Subjects who had prior surgery of penis (circumcision or hypospadias surgery)
* Subjects treated with androgens (Human Chorionic Gonadotrophin or delayed testosterone) within 6 months prior to surgery.
* Intolerance to promestriene or its excipients.
* Not affiliated to a healthy or social security cover.
* Known tumoral risk
* Pure or mixed gonadal dysgenesis (45, X0/46,XY)
Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis

The purpose of this study is to determine the pharmacokinetics and safety of inhaled vancomycin in patients with cystic fibrosis.

The prevalence of methicillin resistant Staphylococcus aureus (MRSA) respiratory infection in patients with cystic fibrosis has increased dramatically over the last decade. Epidemiologic evidence suggests that persistent infection with MRSA may result in an increased rate of decline in FEV1 and shortened survival. Treatment of MRSA is a top priority. Inhaled antibiotics offer the advantage of high concentrations of antibiotic at the site of infection (the airway) while minimizing systemic side effects. Vancomycin is a glycopeptide antibiotic that has activity against MRSA. Anecdotal and retrospective peer-reviewed studies have demonstrated that inhaled vancomycin is safe and potentially effective in patients with cystic fibrosis and MRSA airway infection. Data evaluating the pharmacokinetics of vancomycin in sputum are needed before pursuing treatment trials.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age.
* Confirmed diagnosis of CF based on the following criteria:

  * positive sweat chloride \> 60 mEq/liter (by pilocarpine iontophoresis) and/or
  * a genotype with two identifiable mutations consistent with CF or abnormal NPD, and
  * one or more clinical features consistent with the CF phenotype.
* Chronic sputum producer able to spontaneously produce sputum
* FEV1 \> 40% of predicted normal for age, gender, and height
* Previous use of any inhaled antibiotics within the last year
* Ability to provide written informed consent
* Ability to adhere to the protocol

Exclusion Criteria:

* Use of inhaled or intravenous vancomycin within two weeks of the study visit
* Known history of intolerance to inhaled vancomycin or inhaled albuterol.
* Known history of hypersensitivity to vancomycin or other glycopeptide antibiotics
* History of sputum culture with Burkholderia cepacia complex in the last two years.
* Pregnancy
* Woman who are lactating and not willing to stop nursing on the day of the study visit and the subsequent 48 hours.
* Current use of oral corticosteroids in doses exceeding the equivalent of 10mg of prednisone a day or 20mg of prednisone every other day.
* Patients not willing to hold other inhaled antibiotics (for example TOBI, Cayston, or Colistin) for at least 2 days prior to the study visit.
* Patients not willing to hold loop diuretics (i.e. furosemide, torsemide, ethacrynic acid) on the morning of the study visit.
* History of ABPA or reactive airways disease that has required treatment within the last year.
* Creatinine greater than 2.0 mg/dL within the last year.
* Oxygen saturation ≤ 92% on room air.
* History of patient reported hearing loss
* Any serious or active medical or psychiatric illness, which in the opinion of the investigator, would interfere with patient treatment, assessment, or adherence to the protocol.
* History of or listed for solid organ or hematological transplantation
Comparison of Endotracheal Intubation Success Rates Using Video Laryngoscopes in Entrapped Patients - a Manikin Study

The investigators will compare the success rates of endotracheal intubation in a simulated entrapped car accident victim (manikin) using different video laryngoscopes by experienced emergency physicians.

The investigators hypothesized that video laryngoscopes may improve success rates.


Eligibility Criteria:
Inclusion Criteria:

* experienced emergency physicians

Exclusion Criteria:

* no experience in out-of-hospital emergency medicine
Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy

The purpose of this study is to determine whether nerve growth factor (cerebrolysin®) therapy will improve the psychomotor outcome in infants with moderate and severe hypoxic ischemic encephalopathy after hospital discharge.

Infants with perinatal history of moderate to severe Hypoxic ischemic encephalopathy HIE will receive 10 injections of cerebrolysin IM. Assessment of neurodevelopment will be done before , 3 and 6 months after therapy

Eligibility Criteria:
\*Inclusion Criteria: Infant aged 3-6 months with perinatal history of moderate or severe HIE collected from his NICU's file. Criteria of neonatal asphyxia and encephalopathy according to the American College of Obstetricians and Gynecologist and American Academy of Pediatrics, metabolic acidosis with a cord pH of 7.0 or less or a base deficit of at least 12 mmol/L, early onset of encephalopathy, and multisystem organ dysfunction with exclusion of other possible causes for findings.

Criteria of neonatal asphyxia:

* Full term neonate more than 36 weeks of gestation
* pH of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical-cord blood or any blood during the first hour after birth.
* If, during this interval, a pH is between 7.01 and 7.15, a base deficit is between 10 and 15.9 mmol per liter, or a blood gas is not available, additional criteria are required. These includes an acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest) and either a 10-minute Apgar score of 5 or less or assisted ventilation initiates at birth and continues for at least 10 minutes.

Criteria of neonatal encephalopathy according to Sarnat and Sarnat. Presence of one or more signs in at least three of the following six categories:

* level of consciousness.
* spontaneous activity.
* posture.
* tone.
* primitive reflexes (suck or Moro.
* autonomic nervous system (pupils, heart rate, or respiration). The number of moderate or severe signs determined the extent of encephalopathy; if signs were equally distributed, the designation was based on the level of consciousness.

  \*Exclusion Criteria:
* Severe intrauterine growth retardation.
* Congenital malformations.
* Suspected inborn error of metabolism.
* Suspected inherited neurologic disease.
* Intracranial hemorrhage
* Meningitis
Phase 2 Dose-finding Study to Evaluate the Effects of BA058 in the Treatment of Postmenopausal Women With Osteoporosis

The purpose of this study is to determine whether BA058 is effective in building bone in postmenopausal women with osteoporosis.

This is a randomized, parallel-group, multi-center, dose-finding study to evaluate the effects of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis.

Eligibility Criteria:
Primary Inclusion Criteria:

* The patient has a bone mineral density T-score ≤ 2.5 at the lumbar spine or hip (femoral neck) by dual energy x-ray absorptiometry (DXA). Women with a bone mineral density T-score of 2.0 or lower and a prior low-trauma forearm, humerus, vertebral, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years, or who have an additional risk factor such as age 65 or greater or a strong maternal history of osteoporosis defined as a fracture related to osteoporosis or osteoporosis itself as determined by BMD criteria, are also study candidates.
* The patient is in good general health as determined by medical history and physical examination and is without evidence of clinically significant abnormality in the opinion of the Investigator.

Primary Exclusion Criteria:

* History of bone disorders (e.g., Paget's disease) other than postmenopausal osteoporosis.
* Prior treatment with approved or as yet unapproved bone-acting investigational agents.
* History of carcinoma, nephrolithiasis or urolithiasis within the past five years or osteosarcoma at any time.
* History of radiotherapy (radiation therapy).
Target Planning for Placement of DBS-electrodes and Follow-up of the Clinical Efficacy of Stimulation

Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's disease and other indications. A common target for stimulation is the subthalamic nucleus (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical improvement.

The project aims to describe the variability of target coordinates in the patient group and to relate it to clinical outcome as documented in standardized questionaires.

* Trial with surgical intervention

Deep brain stimulation (DBS) has been established as therapy for severe forms of Parkinson's disease and other indications. A common target for stimulation is the subthalamic nucleus (STN). Nevertheless, there is no agreement on the mechanisms how DBS leads to clinical improvement.

The project aims to describe the variability of target coordinates in the patient group and to relate it to clinical outcome as documented in standardized questionaires.

Eligibility Criteria:
Inclusion criteria:

* Patients fullfill all criteria for implantation of deep brain stimulation (DBS) electrodes
* Patients are able to give informed written consent

Exclusion criteria:

* Patients do not their give informed written consent
Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas

The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic cystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women 18-40 years old
* A diagnosis of endometrioma with diameter of at least 3 cm.
* Candidates for laparoscopic cystectomy

Exclusion Criteria:

* Patients' refusal to participate
* Not candidate for depot medroxyprogesterone acetate such as: cirrhosis, chronic kidney disease, venous thrombosis
* Use of estrogen-suppressive drugs in the preceding 3 months, such as:

Oral contraceptives, GnRH analogues, Progestins, Danazol

* Pathology report present no endometriosis
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of the study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of either sex of any race diagnosed with open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Under age 18.
* Other protocol-defined exclusion criteria may apply.
Renal Blood Flow Measurement With Positron Emission Tomography (PET)

Two investigational chemical tracers, 62Cu-ethylglyoxal bis(thiosemicarbazone) (62Cu-ETS) and 15O-water, will be used in this study to look at how blood moves through the kidneys. The purpose of the study is to see if 62Cu-ETS is effective in showing the blood supply to the kidneys compared to 15O-water. The tracer mixes with the blood and moves through the body. Using positron emission tomography (PET scan) the researchers can see the tracer and can learn more about how the blood moves through the kidneys. The study invites participants who are healthy, without any heart or kidney disease, patients who have kidney disease that require dialysis, and patients who may have a blockage in one of the arteries supplying blood to the kidneys.


Eligibility Criteria:
Arm 1.

Inclusion Criteria:

* males and females, age 18-40 years
* willingness to provide written informed consent

Exclusion Criteria:

* history of coronary artery disease (CAD)
* history of renal disease
* risk factors for cardiac disease, renal disease, or atherosclerosis, including diabetes mellitus, hypertension, tobacco abuse, hyperlipidemia, family history of CAD or chronic renal failure
* history of liver disease or other significant disease
* pregnant females

Arm 2.

Inclusion Criteria:

* males and females, age \> 18 years
* active hemodialysis or peritoneal dialysis for at least six months
* any etiology of chronic renal failure except active glomerular nephritis
* presence of two kidneys
* willingness to provide written informed consent

Exclusion Criteria:

* decompensated heart failure (subjects must be on stable medical therapy for one month)
* any previous renal transplant (subjects may be on renal transplant waiting list)
* history of liver disease
* pregnant females

Arm 3.

Inclusion Criteria:

* males and females, age \> 18 years
* documented evidence of renal artery stenosis equivalent to a 75% stenosis by one of the following clinical tests: MRA, Doppler, Renal Angiogram, Abnormal captopril renal scan
* evidence of renal insufficiency with serum creatinine \>= 1.3 mg/dL
* presence of two kidneys
* willingness to provide written informed consent

Exclusion Criteria:

* revascularization of stenotic renal artery
* decompensated heart failure (subjects must be on stable medical therapy for one month)
* any previous renal transplant (subjects may be on renal transplant waiting list)
* history of liver disease
* pregnant females
Comparison of the Clinical Efficacy and Safety of Endoscopic Superior Rectal Mucosal Ligation and Hemorrhoids Ligation

Endoscopic superior rectal mucosal ligation and hemorrhoids ligation are two types of endoscopic ligation, The aim of this study is to compare the clinical efficacy and safety of these two approaches.If you accept this study,you need to provide case information before the operation, complete the endoscopic treatment according to the routine colonoscopy procedure, and follow-up survey after the operation.


Eligibility Criteria:
Inclusion Criteria:

1. According to the Goligher classification in the Chinese guidelines for the diagnosis and treatment of hemorrhoids (2020) , patients who are diagnosed with grade II-III internal hemorrhoids .
2. Patients who voluntarily participate and sign the informed consent form.

Exclusion Criteria:

1. patients who had severe heart, liver, and kidney disease.
2. patients who had severe immune deficiency.
3. patient\&#39;s general condition is too poor to tolerate endoscopic therapy.
4. patients had a history of pelvic chemoradiotherapy.
5. patients had severe infection or inflammatory lesion in the rectum or anal canal,or the rectum or anal canal had undergone surgery.
6. patient is a pregnant woman.
7. patients who disagree with endoscopic treatment and are concerned about the possible risks refused to sign the informed consent form.
8. the follow-up time is insufficient and the clinical data were incomplete.
Full-dose Atorvastatin After Acute Coronary Syndrome (ACS) in Non-revascularisable Coronary Artery Disease

This study was designed to test the hypothesis that the addition of full-dose atorvastatin (80 mg/day) to conventional medical treatment could reduce ischaemic recurrences after non-ST-elevation acute myocardial infarction (NSTE-AMI) in patients with severe and diffuse coronary artery disease (CAD) not amenable to any form of mechanical revascularisation.


Eligibility Criteria:
Inclusion Criteria:

* non-ST-segment elevation acute myocardial infarction.
* coronary angiography within 48 hours from admission.
* angiographic evidence of severe and diffuse coronary artery disease,not amenable to conventional direct revascularisation techniques by coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI).

Exclusion Criteria:

* ST-segment elevation acute myocardial infarction,
* clinical history of heart failure
* left ventricular ejection fraction \<35%,
* any form of severe valvular dysfunction,
* previous implantation or indication to implant a cardioverter-defibrillator during the index admission,
* any increase in liver enzymes,
* history of any liver or muscle disease,
* renal failure with serum creatinine \>2.5 mg/dL (221 mmol/L),
* need for continued use of intravenous medications to relieve anginal symptoms,
* presence of any major comorbidity with life expectancy \<24 months.
Evaluating the Change of Overactive Bladder Symptoms in Women Post Pubovaginal Sling Procedure for Stress Incontinence

Pubovaginal sling (PVS) procedures are designed to curtail bladder leakage brought about by strenuous events such as child birth. A common purported side effect of PVS is urgency, the feeling of a compelling need to void with little warning. Other overactive bladder (OAB) adverse effects that some claim to develop post-op include further leakage (incontinence), frequency and nocturia (night time leakage). Anecdotal evidence from our clinic however, suggests that such de novo OAB symptoms are rarely induced by PVS, and may in fact be alleviated by said procedure. It is our aim to investigate this relationship in our clinic.

As a prospective member of this study, you will be asked to complete five surveys. The first survey will be administered prior to your pubovaginal sling. This will be used to establish your baseline experience of OAB. Over the course of the next year, you will be asked to complete the four remaining surveys at regularly scheduled check-ups.


Eligibility Criteria:
Inclusion Criteria.

* Post-pubovaginal sling patient.
* Complete agreement and signing of Informed Consent Form.

Exclusion Criteria.

* Currently taking antimuscarinics or α1 blockers.
* Patients with urinary retention, dependent on dialysis, gastroparesis or narrow angle glaucoma.
ACTIVATE: Standard Worksite Health Program vs. Activated Consumer

A 3-year, randomized, controlled trial comparing a traditional worksite health promotion program and an activated consumer program on health practices, health status and patient activation measures.

The design is a cluster, randomized controlled trial of two companies with three arms in each company. The arms include two control groups (one from each company), two intervention groups using a standard health promotion intervention, and two intervention groups that constitute using an activated consumer intervention. The standard intervention includes educational offerings to address health behaviors. The activated consumer intervention offers shorter education sessions and includes decision tools and skills development for working with heath care providers to better manage health and clinical conditions. Variables include health risk assessments, clinical measures such as lipids, blood pressure, body mass index, and tobacco use, perception of health care consumer practices, claims costs, and absenteeism analysis.

Eligibility Criteria:
Inclusion Criteria:

* Airline and health care employees

Exclusion Criteria:

* Minors