cyrilzakka/clinical-trials huggingface dataset:
Brain Function in Children Previously Treated on Clinical Trials POG-9605 and POG-9201

RATIONALE: Assessing the effects of methotrexate on brain function in children may improve the ability to plan treatment and decrease side effects.

PURPOSE: Clinical trial to compare brain function of children who have been previously treated with methotrexate.

OBJECTIVES:

* Compare the incidence of neuropsychological abnormalities and leukoencephalopathy in children previously treated with methotrexate on protocols POG-9605 versus POG-9201.

OUTLINE: This is a multicenter study.

More than 3 years after completion of therapy, patients undergo 9 different tests to assess intelligence, memory, learning, attention, concentration, processing of information, functioning, and visual-motor integration. Patients also undergo MRI of the head.

PROJECTED ACCRUAL: A total of 30-54 patients previously treated on protocol POG-9201 will be accrued for this study. A total of 60-108 patients previously treated on protocol POG-9605 will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Previously enrolled on POG-9201 or POG-9605

  * Good prognosis by NCI risk (9201 and 9605 stratum 1)
* Eligible for the therapeutic study
* Completed therapy by 12/31/2000
* No CNS3 at diagnosis
* No relapsed disease

PATIENT CHARACTERISTICS:

Age:

* 1 to 9 at diagnosis

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No Down syndrome

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* See Disease Characteristics
A Human Proof of Concept Study for [11C]-RO5011232 as Radiotracer and Study of the Binding of RO4917523 to Human mGlu5 Brain Receptor at Steady-State in Healthy Volunteers

This open label, non-randomized, parallel group study will evaluate \[11C\]-RO5011232 as radiotracer for brain mGlu5 receptor occupancy and investigate the binding of RO49917523 to human mGlu5 brain receptor at steady-state in healthy volunteers. In Parts I, II and III, positron emission tomography (PET) assessments of specific uptake of the radiotracer and whole body dosimetry will be made after intravenous injection of \[11C\]-RO5011232. In Part IV, subjects will receive RO4917523 orally daily for 14 days while receiving three single intravenous bolus injections of \[11C\]-RO5011232. The anticipated time on study treatment is up to 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female volunteers as determined by medical history, physical examination, 12-lead ECG, and routine clinical laboratory measurements
* Age 18 to 65 years inclusive
* Body mass index (BMI) between 18 to30 kg/m2 inclusive and body weight at least 50 kg
* Appropriate body size (less than 195 cm \[6 feet and 5 inches\]) in order to accommodate the whole body scanning

Exclusion Criteria:

* History of or presence of clinically significant psychiatric condition, as evaluated by a psychiatrist before enrolment
* History of head trauma with prolonged loss of consciousness (\>10 minutes) or any neurological condition or a history of migraine headaches
* Contraindications to MRI procedures (Part I, III and IV)
* Subjects suffering from claustrophobia or who would be unable to undergo magnetic resonance imaging (MRI) or PET scanning
* Positive pregnancy test at screening or on any day preceding a PET scan
* Lactating women
* Positive for hepatitis B, hepatitis C or HIV infection
* Any history of alcohol or drug abuse within the last 6 months
* Regular smoker or nicotine user (\>10 cigarettes per day)
* Participation in an investigational drug or device study within three months prior to screening
Confocal Laserscanning Microscopy for Detection of Barretts Esophagus

Four quadrant biopsies in regular ranges is the goldstandard in monitoring this disease. The ideal situation for the endoscopist is to visualize cellular structures, which implies having microscopic imaging available. A potential candidate to fill this gap could be confocal fluorescence microscopy (Cellvizio®-GI and Mauna Kea Technologies). To compare the gold standard with the confocal fluorescence microscopy for detection of metaplastic - or intraepithelial neoplastic changes of barrett-suspicious esophageal mucosa this study has been initiated.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* regular esophagogastroduodenoscopy for patients with known barrett esophagus (at least stadium C0M1)
* patients presenting for endoscopic mucosectomy with intraepithelial neoplastic changes \<1cm
* patients presenting with suspected intraepithelial neoplastic changes
* patients receiving acid suppressive therapy in standard dose for at least 4 weeks

Exclusion Criteria:

* no informed consent
* thrombocytopenia, quick \<50%, PTT \>50 sec
* patients with coronary heart disease or existent valve plasties
* women with potential pregnancy
* patients with chronic renal failure
* patients with allergies
* patients with chronic obstructive pulmonary disease
DAILIES® AquaComfort Plus® Multifocal (MF) - Comparative Assessment of Visual Performance

The purpose of this study is to evaluate the visual performance of DAILIES® Aqua Comfort Plus® (DACP) MF contact lens using new objective measurements.

In this 3-treatment, 3-period, 6-sequence crossover study, each subject received all 3 products in randomized order and used 1 product at a time for a duration of 5±1 days before switching to the next assigned product.

Eligibility Criteria:
Inclusion Criteria:

* History of soft contact lens wear (hydrogel or silicone hydrogel) in both eyes during the past 3 months and able to wear lenses at least 8 hours a day, 5 days a week
* Spectacle add between +1.50 and +2.50 diopters (D) (inclusive)
* Requiring lenses within the power range of both study contact lenses to be fitted
* Cylinder, if present, less or equal to 0.50D in both eyes at Visit 1
* Vision correctable to 20/30 (0.2 logMAR) or better in each eye at distance
* Acceptable fit with both study contact lenses
* Willing to wear lenses every day or at least for a minimum of 5 days per week 6 hours per day, every day if possible
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Current multifocal contact lens wearer
* Current monovision wearer or failed attempt with monovision
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
* Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator
* Eye injury or surgery within 12 weeks immediately prior to enrollment in this trial
* Any moderate or severe ocular condition observed during the slitlamp examination at the enrollment visit
* History of herpetic keratitis, ocular surgery or irregular cornea
* Prior refractive surgery (e.g. LASIK, PRK, etc)
* Monocular (only 1 eye with functional vision) or fit with only 1 lens
* Habitually uncorrected anisometropia \>2.00D
* Clinically significant anisocoria
* Participation in any clinical trial within 30 days of the enrollment visit
* Other protocol-defined exclusion criteria may apply
Work Productivity in Active Ankylosing Spondylitis (AS) Patients Treated With Enbrel.

Patients with Ankylosing spondylitis more frequently discontinue work. This study measures the impact of Enbrel on work participation.

Purely descriptive

Eligibility Criteria:
Inclusion Criteria:

* Active AS patients (as judged by the treating MD) who are currently employed.
* Patients who are scheduled by their rheumatologist to initiate treatment with Etanercept.

Exclusion Criteria:

* Patients who initiated a procedure for eligibility of work disability/pension.
* Patients with previous use of TNF-alpha inhibitors either in commercial use, or in a study for the treatment of AS or a related spondylarthropathy condition.
Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection

Compare the quality of life at 6 months between 2 populations of patients followed for terminal ileitis of Crohn's disease treated with anti-TNF or ileocecal resection.

Two groups of patients suffering from Crohn's terminal ileitis will be matched by sex, age (A2, A3), the time evolution of the disease, the length of the diseased ileal segment (less than 10 cm; 10 to 30; 30 to 50 cm) and the Montreal classification (B1, B2). The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time. The surgical group are the patients operated on for the first time by means of ileocecal resection by laparoscopy or laparotomy without any severity criteria or perianal lesions and do not require prophylactic treatment of recurrence.

Eligibility Criteria:
Inclusion Criteria:

* isolated Crohn's ileitis without history of bowel resection and never previously been treated with anti-TNF
* Men and woman over 18 years
* Patient with social security cover
* reapproved indication during multidisciplinary meeting
* Patient able to receive clear information in written and oral
* Informed consent signed by the patient

Exclusion Criteria:

* Prophylactic treatment of recurrence before endoscopic control at the 6th postoperative month.
* Contraindication to Anti-TNF after the initial lap works.
* The side effects of surgery or anti-TNF are not exclusion criteria.
Comparison of VT Ablation Outcomes Using Remote MAGNETIC Navigation Versus Manual Approach in a Low LVEF Population

The study purpose is to demonstrate that ventricular tachycardia (VT) ablation using the Niobe™ ES system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT in a low ejection fraction population.

This study is a randomized, single-blind, prospective, multi-center post market evaluation. Subjects will be screened for study eligibility and asked to complete written informed consent prior to any study specific testing assessments. After completing written informed consent, a total of 386 subjects will be randomized on a 1:1 basis to receive VT ablation treatment using either the Niobe ES or standard manual catheter ablation treatment using commercially available products. This will be the largest randomized VT study comparing outcomes from RMN to manually guided catheter ablation procedures. Subjects will be randomized according to a computer-generated randomization scheme. Randomization will be blocked at the study site level and subjects will be blinded to group assignment. Since quality of life measurements will be collected during follow-up, this study is single-blinded in order to mitigate patient bias. Clinical evaluations will not be masked to the treating physician.

Eligibility Criteria:
Inclusion Criteria:

* subject has had an ICD previously implanted
* subject has drug-refractory monomorphic VT
* subject is a candidate for ischemic VT RF ablation
* subject has had a myocardial infarction
* subject has a LVEF less than or equal to 35%

Exclusion Criteria:

* subject has non-ischemic VT
* subject has a history of stroke within 1 month prior to enrollment
* subject has had an acute myocardial infarction within 30 days prior to enrollment
* subject has unstable angina
* subject has undergone cardiac surgery within 60 days prior to enrollment
* subject is pregnant or nursing
* subject has a limited life expectancy of 1 year or less (Subjects requiring LVAD/IABP intraprocedural support may be enrolled as long as life expectancy is at least 1 year following the ablation procedure.)
* subject is unable or unwilling to cooperate with study procedures
* subject has a known presence of intracardiac thrombi as determined by echocardiography
* subject has a major contraindication to anticoagulation therapy or coagulation disorder
* subject has had a previous pericarditis or cardiac tumor
* subject has had previous thoracic radiation therapy
* any other reason the investigator considers the subject ineligible
The Effect of Two Methods Applied to Mothers on Insufficient Milk Perception, Breastfeeding Motivation, Fatigue, Anxiety

Although the World Health Organization predicts the caesarean section rate to be 10-15%, the caesarean section rate in Turkey is 52%, more than three times the international standard. It is very important to eliminate the physical and psychosocial problems experienced by women during this period, to encourage breastfeeding, and at the same time to protect and improve maternal health. Maintaining the mother's well-being after cesarean section and supporting pharmacological treatment with non-pharmacological practices have an important place in nursing care. Therefore, this study will examine the effects of oxytocin massage and reflexology applied to mothers in the post-cesarean period on the perception of insufficient milk, breastfeeding motivation, fatigue, anxiety and uterine involution.


Eligibility Criteria:
Inclusion Criteria:

* Mothers who gave birth at the age of 18 and over
* The one who is married
* At least primary school graduate,
* Primiparous mothers who gave birth by cesarean section,
* Having a single, healthy newborn at full term,
* Those who did not experience any problems during pregnancy and the early postpartum period,
* The tissue integrity in the area to be applied is complete and healthy,
* Breastfeeding her baby after birth,
* The baby is healthy, has no problems with the sucking reflex and does not have any congenital anomalies,
* Women who agree to participate in the research will be included in the study.

Exclusion Criteria:

* Those who gave birth by cesarean section before the 37th week of pregnancy,
* Women who gave birth by cesarean section with combined anesthesia,
* Discharged before 36 hours after birth,
* Having chronic diseases such as heart disease, diabetes, hypertension,
* Those with infectious diseases, infections, open wounds, masses, fractures, dislocations, deformities, varicose veins, burns, eczema, hematomas, thrombophlebitis, deep vein thrombosis on the foot skin,
* Experiencing any postpartum complications,
* Their baby is not with their mother for any reason,
* Those who have received a psychiatric diagnosis such as anxiety and depression,
* Women who want to leave the research at any stage of the research
Mini-Crush or Controlled Balloon-Crush for True Coronary Bifurcation Lesions

The mini-crush technique is one of the leading 2-stent techniques frequently applied by interventional cardiologists to treat complex bifurcation lesions. In the last 20 years, many technical innovations and iterations of mini-crush technique have been developed, and it maintains its popularity among invasive cardiologists. Moreover, mini-crush and double kissing-crush techniques have been compared in terms of clinical results in both left main and non-left main coronary bifurcation patient populations and no significant difference was found. However, the most important challenges of the mini-crush technique are the rewiring and advancement of a 1:1 non-compliant side-branch balloon after the main branch stent has been implanted. These challenges usually necessitate the use of a low profile balloon or additional support maneuvers (such as anchor balloon). Recently, a novel modified mini-crush-crush technique (controlled balloon-crush) has been introduced to the literature and is one of the most up-to-date crush techniques. The main advantage of this technique over the contemporary mini-crush technique is that the side branch can be easily rewired and the 1:1 size non-compliant balloon can easily pass through the crushed stent structure in the ostial part of the side branch. The basic rationale of this is that the crushing of the side branch stent is done in a more controlled manner (by slowly deflation of the side branch stent balloon) and this causes less disruption of the stent cells. This prospective observational study aims to assess the procedural and 1-year clinical outcomes of the contemporary mini-crush and controlled balloon-crush (modified mini-crush) double stenting techniques in patients with true coronary bifurcation lesions.


Eligibility Criteria:
Inclusion Criteria:

* Aged \>18
* PCI with mini-crush or controlled balloon-crush
* Complex coronary bifurcation lesion (Medina 0.1.1 and Medina 1.1.1)

Exclusion Criteria:

* Non-complex bifurcation anatomy
* Bail-out 2-stent (reverse mini-crush or reverse controlled balloon-crush)
* ST-elevation myocardial infarction
* Cardiogenic shock status
* In-stent restenosis
* A history of coronary artery bypass grafting
* Implantation of bare-metal stent
* End-stage hepatic or renal disease
* \<1-year life expectancy
Carotid Intima Media Thickness (CIMT) in Epistaxis

Epistaxis is a very frequent emergency among adults and often needs specialised treatment in an ENT-department. Among others, atherosclerosis is often named as a reason for an increased risk for Epistaxis. To evaluate whether or not this is the case, the investigators examined the carotid intima media thickness via ultrasound in patients who were treated in the ENT-department of the University Hospital of Zurich.


Eligibility Criteria:
Inclusion Criteria:

* active or very recently active anterior or posterior epistaxis
* at least 18 years old

Exclusion Criteria:

* posttraumatic or postoperative epistaxis
Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs

Primary Objective:

To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic drugs

Secondary Objective:

To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs To assess change in participant's treatment satisfaction using DTSQs (Diabetes Treatment Satisfaction Questionnaire)

The maximum study duration per participant is 27 weeks including a screening period of up to 2 weeks, a 24-week treatment period and a post-treatment follow-up phone call visit after 3 days after the end of treatment.

Eligibility Criteria:
Inclusion criteria :

* Participants with Type 2 diabetes mellitus
* Participants who are insulin naïve on at least one oral antihyperglycemic drug (metformin,sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) with or without glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for a minimum period of 6 months prior to screening.
* HbA1c between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.

Exclusion criteria:

* History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit.
* Proliferative retinopathy or maculopathy requiring treatment according to the Investigator
* Treatment with any insulin including basal insulin, mixed insulin (premixes), rapid insulin, and fast-acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted).
* Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Open-label Trial to Check the Safety and Tolerability of RTX-GRT7039 Injections for Pain Associated With Osteoarthritis of the Knee

An open-label, single-arm clinical trial to confirm the safety of monoarticular injections or bi-lateral intra-articular injections of RTX-GRT7039 in patients who have pain associated with osteoarthritis of the knee despite standard of care.

This trial comprises a total observation period of up to 78 weeks.

Eligibility Criteria:
Inclusion Criteria:

* The participant has given written informed consent to participate.
* The participant is 18 years of age or older at the Screening Visit.
* The participant has a diagnosis of osteoarthritis of the knee based on American College of Rheumatology criteria and functional capacity class of I to III.
* There is a documented history indicating that participant has insufficient pain relief with previous Standard of Care.

Exclusion Criteria:

* The participant has past joint replacement surgery of the index knee.
* The participant has a history of significant trauma or surgery (e.g., open or arthroscopic) to the index knee within 12 months of Screening.
* The participant has periarticular pain at the index knee from any cause other than osteoarthritis, including referred pain, bursitis, tendonitis.
* The participant has clinical hip osteoarthritis on the side of the index knee.
* The participant has a history of osteonecrosis, subchondral insufficiency fracture, atrophic osteoarthritis, rapidly progressing osteoarthritis (RPOA) Type I or Type II,pathologic fracture, primary or metastatic tumor, or joint infection in the index knee.
* The participant has significant malalignment of anatomical axis (medial angle formed by the femur and tibia) of the target knee (varus \>10°, valgus \>10°) by radiograph as assessed by independent Central Readers at Screening Visit.
* The participant has other conditions that could affect trial endpoint assessments of the index knee.
* The participant has current clinically significant disease(s) or condition(s) that may affect safety assessments, or any other reason which may preclude the participant's participation for the full duration of the trial.
* The participant has a history of hypersensitivity to resiniferatoxin (RTX) or any similar component (capsaicin, chili peppers).
* The participant is currently participating or was participating in another investigational drug trial within 3 months prior to the Screening Visit.
* The participant is an employee of the investigator or trial site, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial site or is a family member of the employees or the investigator.

The non-index knee is not eligible for treatment in the trial, if any of the knee-related exclusion criteria applies to the non-index knee.
WaveLight® Refractive Myopic Study

The purpose of this study is to evaluate outcomes of subjects undergoing myopic surgery using the WaveLight® Refractive Suite (Excimer EX500 and Femtosecond FS200 lasers).


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to understand and sign an informed consent form.
* Have refractive error (in both eyes) that requires refractive surgery.
* Willing to undergo LASIK surgery using the Wavelight® Refractive Suite.
* Myopia between 0.00 to -12.0 diopters pre-operatively.
* Astigmatism between 0.00 to +6.00 diopters pre-operatively.
* Willing and able to attend post-operative examinations per protocol schedule.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Participation in a clinical study within the last 30 days.
* History of previous corneal surgery in either eye.
* Multifocal ablations in either eye.
* PRK or PTK surgery in either eye.
* Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc.
* Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study.
* Unable to discontinue contact lens wear as specified in protocol.
* History of Herpes simplex or Herpes zoster keratitis.
* Active ocular rosacea.
* Lyme disease.
* History of dry eye that is unresponsive to treatment.
* Severe ocular allergies.
* Other medical conditions and use of medications as specified in protocol.
* Pregnant or planning to become pregnant during the study.
* Other protocol-specified exclusion criteria may apply.