cyrilzakka/clinical-trials huggingface dataset:
Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study

The hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus, the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted endoscopy with that of conventional endoscopy using high definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI) in patients with Barrett's esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age.
* Must be patients undergoing standard of care EGD for the confirmation of dysplasia in BE or EET for dysplasia in BE.
* Must be able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Prior endoscopic treatment for BE.
* Unable to tolerate sedation due to medical comorbidities.
Comparison of Techniques for Assessing Cardiac Output and Preload in Critically Ill Pediatric Patients

The ability to measure cardiac output (CO) accurately and reproducibly at frequent intervals remains elusive to the clinician caring for critically ill pediatric patients even though a large proportion of these children are known to have hemodynamic compromise as a result of their illness. Current techniques used in adults to measure CO are not suitable for routine use with pediatric patients. A new ultrasound dilution approach provides an opportunity to measure cardiac output and blood volumes in pediatric patients. The main aim of this study is to compare CO measured by the new method with the clinician's estimate and implied CO from the measurement of the arteriovenous oxygen content difference.


Eligibility Criteria:
Inclusion Criteria:

* Patients with in situ central venous and arterial catheters
* Ability to draw blood from arterial and central venous catheters
* Presence of parent or guardian to provide consent

Exclusion Criteria:

* Patients over 16 years of age.
Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique

The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.

In conventional cleft grafting technique, there is always risk for grafted bone resorption and recurrence of fistula formation. So alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments will work more efficient and prevent the fore mentioned risk of graft resorption and recurrence of fistula.

In conventional cleft grafting techniques, most of the cases reported in literature raised a debate regarding the final gained amount of bone, with subsequent recurrence of oronasal fistula. In this study, alveolar cleft grafting using anterior iliac crest bone particles combined with microplate fixation of maxillary segments and the conventional grafting technique will be compared to evaluate which technique will offer better reconstruction of the alveolar ridge with maintained bone width and height.

Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old).
* repaired cleft lip.
* Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
* Both genders males and females will be included.

Exclusion Criteria:

* General contraindications to surgical intervention of the area.
* Patients with unilateral maxillary alveolar cleft.
* Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft
* Subjected to irradiation in the head and neck area less than 1 year before surgery.
* Untreated periodontitis.
* Poor oral hygiene.
* Uncontrolled diabetes.
* Immunosuppressed or immunocompromised.
* Active infection or severe inflammation in the area intended for graft placement
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly followed.
* Unable to attend a 9-month follow-up.
A Study in Healthy Male Volunteers Investigating the Safety, Absorption and Elimination of Single Doses of GLPG4059

The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of GLPG4059 in healthy volunteers after single oral administrations of GLPG4059 (SAD), compared to placebo (part 1). The effect of food (FE) (high-fat, high calorie) on the pharmacokinetics and relative bioavailability (rBA) of GLPG4059 will be assessed (part 2).


Eligibility Criteria:
Inclusion Criteria:

* Male between 18-54 years of age (extremes included), on the date of signing the informed consent form (ICF).
* A body mass index (BMI) between 18-30 kg/m2, inclusive.
* Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests, available at screening and prior to randomization. ECG and vital signs parameters must be within the normal ranges. Bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) must be no greater than 1.5x upper limit of normal (ULN). Fasting plasma glucose must be \<6.99 mmol/L, fasting defined as no caloric intake for at least 8 hours and hemoglobin A1c (HbA1c) \<6.5% (48 mmol/mol). The test should be performed in a laboratory using a method that is national glycohemoglobin standardization program (NGSP) certified and standardized to the diabetes control and complications trial (DCCT) assay. Other clinical laboratory safety test results must be within the reference ranges or test results that are outside the reference ranges need to be considered not clinically significant in the opinion of the investigator.

This list only contains the key inclusion criteria.

Exclusion Criteria:

* Known hypersensitivity to Investigational Medicinal Product (IMP) ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator.
* Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) or history of hepatitis from any cause with the exception of hepatitis A that was resolved at least 3 months prior to first dosing of the IMP.

This list only contains the key exclusion criteria.
Procalcitonin as a Tool to Shorten Antibiotic Therapy in the ICU

Recently, biomarkers like procalcitonin have been studied in order to help physicians to decrease the duration of the antibiotic therapy. The investigators objective was to assess whether the decrease in procalcitonin levels could be used to reduce the antibiotic therapy in critically ill patients with a proven infection without risking a worse outcome.


Eligibility Criteria:
Inclusion Criteria:

* all patients admitted in the intensive care unit with sepsis, severe sepsis and septic shock with a microbiologically confirmed infection (blood, urine, tracheal aspirate or bronchoalveolar fluid culture)

Exclusion Criteria:

* onset of the antibiotic therapy more than 48 hours before the date when the cultures were performed
* patients less than 18 years old
* known pregnancy
* infections requiring prolonged antibotic therapy such as endocarditis, hepatic or brain abscess, deep abscess, mediastinitis and osteomyelitis
* severe infection caused by virus, parasites, fungi or chronic prostatitis
* negative cultures in patients with suspected sepsis, severe sepsis or septic shock
Thalidomide and Cyclophosphamide in Treating Children With Recurrent or Refractory Childhood Cancers

RATIONALE: Thalidomide may kill tumor cells by stopping the growth of new blood vessels to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and cyclophosphamide in treating children who have recurrent or refractory childhood cancers.

OBJECTIVES: I. Determine the efficacy and toxic effects of thalidomide and cyclophosphamide in patients with recurrent or refractory pediatric malignancies.

OUTLINE: Patients receive oral thalidomide 4 times daily. Cyclophosphamide is administered IV over 1 hour once every 4 weeks, beginning on the same day as thalidomide. Treatment continues in the absence of unacceptable toxicity or disease progression. Tumor response is assessed every 3 months.

PROJECTED ACCRUAL: A total of 45-80 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically proven pediatric malignancy, except when there is appearance consistent with brainstem tumor on MRI, a tumor marker positive for germ cell tumor, or ophthalmologic diagnosis of intraocular retinoblastoma Failed conventional treatment or conventional therapy is not available Measurable disease by MRI, CT scan, biochemical tumor markers, cytology, or bone marrow examination

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Lansky 60-100% OR Karnofsky 60-100% Life expectancy: At least 6 weeks Hematopoietic: Absolute neutrophil count at least 750/mm3 (between 300-750/mm3, if due to bone marrow infiltration by malignancy) Platelet count at least 75,000/mm3 (between 20,000-75,000/mm3, if due to bone marrow infiltration by malignancy) Hepatic: Bilirubin less than 2.0 mg/dL ALT less than 3 times upper limit of normal (ULN) Renal: Creatinine less than 2 times ULN OR Creatinine clearance at least 70 mL/min Neurologic: No peripheral neuropathy grade 3 or 4 No seizure disorder in patients without CNS malignancies Other: Not pregnant or nursing Negative pregnancy tests during study and for 1 month after final dose of thalidomide Fertile patients must use effective contraception during and for at least 1 month after study

PRIOR CONCURRENT THERAPY: See Disease Characteristics No limit on the number of prior agents or regimens received Biologic therapy: Prior bone marrow transplantation allowed Chemotherapy: Recovered from prior chemotherapy No prior thalidomide Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 4 weeks since prior major surgery (2 weeks for minor surgery, excluding central venous catheter placement procedures)
Turkish Validity and Reliability of Gait Outcomes Assessment List (GOAL)

The aim of this study is to investigate the reliability and validity of the Turkish Gait Outcomes Assessment List (GOAL) Questionnaire, in children with cerebral palsy (CP) with GMFCS level1, 2, and 3.

Most children with cerebral palsy (CP) can walk. Musculoskeletal disorders of these children cause deterioration in gait functions. Disruptions in gait limit children's participation. To minimize these impairments, various interventions are usually applied to children with CP who can walk. The ultimate goal of these interventions is to help these children achieve the best possible participation in activities of daily living. In addition, goal determination by children and families in treatment planning is important in terms of treatment success. The Gait Outcomes Assessment List (GOAL) is a scale developed to contribute to the determination of these goals. This questionnaire includes the priorities, expectations, and goals of children with CP who can walk and reveals their walking characteristics. The questionnaire is used in two languages, English and German, and there is no Turkish version of the questionnaire. Therefore, the aim of this study is to create the Turkish version of the 'Gait Outcomes Assessment List (GOAL)' family and child questionnaires and to examine its validity and reliability.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Cerebral Palsy
* Being able to read and write Turkish

Exclusion Criteria:

* Children who have had botox or orthopedic surgery in the last 6 months
Comprehensive Analysis of Hypoxia in Prostate Cancer: Diagnostic Markers and Prognostic Significance

A single-center cohort study to identify uni- and multivariate associations between marker gene expression and clinico-pathological parameters for the detection of robust and novel prognostic tools in prostate cancer

1. To perform a large scale assessment of tissue hypoxia by pimonidazole and hypoxia marker gene expression in human prostate cancers
2. To characterize expression and hypoxia/HIF-responsiveness of myoglobin, cytoglobin, α-hemoglobin in prostate tumors and cell lines
3. To identify uni- and multivariate associations between marker gene expression and clinico-pathological parameters for the detection of robust and novel prognostic tools in prostate cancers

Eligibility Criteria:
Inclusion criteria:

* Patients with biopsy-proven adenocarcinoma of the prostate who are to be treated with radical prostatectomy at the Department of Urology, University Hospital of Zurich
* Written informed consent

Exclusion criteria:

* Metastatic prostate cancer
* Contraindications to the class of investigational product under study, e.g. known hypersensitivity or allergy to the investigational product
* Severe heart or lung disease
* Severe liver or kidney dysfunction
* Severe stridor
* Distant metastases
* Concurrent treatment for other malignant disease
* Prior hormonal therapy or radiotherapy
Validation Study Using a Time-lapse Morphometry MIRI Imaging Incubator

The purpose of this study is to evaluate the safety and efficacy of the MIRI-TL time-lapse incubator and CultureCoin dish compared to standard big-box incubators and standard culture dishes used for embryo culture.

Following randomization and standard ovarian stimulation protocols to obtain a sufficient number of mature (MII) oocytes, these oocytes will be fertilized by Intra-Cytoplasmic Sperm Injection (ICSI). If a patient has been randomized to the study group, all inseminated oocytes and subsequently all fertilized diploid (2PN) zygotes will be placed in the CultureCoin and then into the MIRI-TL Time-lapse incubator and cultured as per normal protocol to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur in a fresh or frozen embryo transfer cycle.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Women undergoing in vitro fertilization treatment using their own or frozen oocytes
* Fresh or Frozen Embryo Transfer
* Fertilization by ICSI
* At least 4 diploid (2PN) embryos at fertilization check
* Willing to have all inseminated oocytes imaged by Miri
* Willing to comply with study protocol and procedures Willing to provide written informed consent

Exclusion Criteria:

* Fertilization using surgically removed sperm
* History of cancer
BAX 326 (rFIX) Continuation Study

The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric study 251101.


Eligibility Criteria:
Main Inclusion Criteria:

* Subject and/or legal representative has/have voluntarily provided signed informed consent
* Subject has completed Baxter clinical study 250901 (pivotal study) or Baxter clinical study 251101 (pediatric study)
* Subject was 12 to 65 years old at the time of screening for Study 250901 or \< 12 years old at the time of screening for Study 251101
* Subject has severe (FIX level \< 1%) or moderately severe (FIX level 1-2%) hemophilia B (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested at screening at the central laboratory
* Subject has not developed an inhibitory FIX antibody during Baxter Pivotal Study 250901 or Pediatric Study 251101

Main Exclusion Criteria:

* Subject received factor IX product(s) other than BAX 326 upon completion of Baxter Pivotal Study 250901 or Pediatric Study 251101
* Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B
* For subjects transferring from Pivotal Study 250901: Subject's weight is \< 35 kg or \> 120 kg
* Subject is planned to take part in any other clinical study, with the exception of BAX 326 Surgery study as described in this protocol, during the course of the Continuation Study
Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition

This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition.

1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy.

1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients\>18 years of age undergoing endoscopy for any of the following indications:

Indications for Tissue Apposition:

* Closure of perforations
* Closure of full thickness defects created during endoscopic full thickness resection
* Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection
* Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM)
* Stent fixation
* Closure of fistulas
* Natural Orifice Transluminal Endoscopic Surgery defect closures
* Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair)
* Primary endoscopic sleeve gastroplasty

Exclusion Criteria:

* Patients unable or unwilling to provide consent
* Pregnant patients
* Coagulation disorders (INR \>1.8, platelet \<50,000)
* GI Bleeding
* Hemodynamic instability
* Enrollment in another device or drug study that may confound the results
Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of PF-00299804 In Patients With Advanced Solid Tumors

The primary purpose of this study is to study the side effects of PF-00299804 and determine the highest dose that can be safely administered in patients with advanced cancer.


Eligibility Criteria:
Inclusion Criteria:

* Malignant solid tumor for which there is no currently approved treatment
* Adequate bone marrow, liver, cardiac, and kidney function

Exclusion Criteria:

* Cardiac disease
* Anticancer therapy within 4-6 weeks (depending on therapy)
* Pregnant or breast-feeding
A Randomized, Open-Label, Crossover, Multicenter, Single Dose Comparator Study Evaluating Onset Of Penile Rigidity In Men With Erectile Dysfunction Who Are Treated With Sildenafil And Tadalafil

The objective of this study was to determine and compare the minimum time required to achieve penile rigidity greater than or equal to 60% at the base of the penis that is sustained for at least 3 minutes measured by Rigiscan®, following visual sexual stimulation post dose of 100 mg sildenafil citrate and 20 mg tadalafil in men with erectile dysfunction (ED).


Eligibility Criteria:
Inclusion Criteria:

* Included subjects were 18 years of age or older
* A clinical diagnosis of erectile dysfunction
* Known responders to either 100 mg sildenafil or 20 mg tadalafil.

Exclusion Criteria:

* Excluded were subjects who were unable to achieve penile rigidity of greater than or equal to 20% at the base of the penis that was sustained for at least 3 minutes
* Subjects who are able to achieve penile rigidity of greater than or equal to 60% at the base of the penis that was sustained for for at least 2 minutes or subjects who are able to achieve penile rigidity of greater than or equal to 80% at the base of the penis that is sustained for for at least 1 minute measured by Rigiscan®, at screening with no therapy, within 60 minutes following visual sexual stimulation
* Subjects currently using any commercially available treatments for erectile dysfunction
* Subjects on nitrates.
Effect of Coadministration of Itraconazole on the Pharmacokinetics of CRD-740

This is a Phase 1, single-site, open-label, fixed sequence crossover study to investigate the effect of coadministration of itraconazole on the pharmacokinetics of CRD-740 in healthy male and female subjects. Subjects will be admitted into the study site on Day -1 and will be confined to the study site until discharge on Day 16. Subjects will receive CRD-740 orally on Days 1 and 10. Itraconazole will be given once daily, orally, on Days 7 through 15.


Eligibility Criteria:
Inclusion Criteria:

1. Males or females, of any race, between 18 and 55 years of age, inclusive.
2. Body mass index between 18.0 and 32.0 kg/m2, inclusive.
3. In good health, determined by no clinically significant findings as assessed by the investigator.
4. Adhere to all contraception criteria.

Exclusion Criteria:

1. Significant medical history as determined by the investigator.
2. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, including itraconazole, unless approved by the investigator (or designee).
3. History of stomach or intestinal surgery or resection that would potentially alter absorption or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
4. Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, as judged by the investigator.
5. History or presence of an abnormal ECG.
6. Use or intend to use any medications/products/herbal remedies known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to check-in, unless deemed acceptable by the investigator (or designee).
7. Drugs affecting CYP3A4 should be refrained from use for 3 weeks, or 5 half-lives (whichever is longer), prior to check-in through to follow-up.
8. Positive urine drug screen at screening or positive alcohol breath test result or positive urine drug screen at check-in.21. History of alcoholism or drug/chemical abuse within 12 months prior to check-in.
9. Ingestion of poppy seed, Seville orange, or grapefruit containing foods or beverages within 7 days prior to check-in.
Robotic Assisted Early Mobilization in Ventilated ICU Patients

Feasibility trial investigating robotic assisted early mobilization vs. early mobilization in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Invasive mechanically ventilated and expected to be ventilated for another 24 hours
* Cardiovascular stability, allowing mobilization
* Respiratory stability, allowing mobilization

Exclusion Criteria:

* Bed-bound before ICU admission
* Bed-rest order or contraindication of weight load of the lower extremity or spine
* Severe skin lesions or fasciitis in the area of contact with the device or rhabdomyolysis
* Fresh SAB, ICB or elevated ICP
* Status epilepticus
* Acute intoxication
* Shock with catecholamine doses \>0.3µg/kg/min or acute bleeding including organ ruptures
* Multiorgan failure with lactate \> 4 mmol/l
* Body height outside the range 150-195 cm
* Body weight outside the range 45-135 kg
* pAVK IV°
* Pacemakers or other electrical stimulators
* Implanted medical pumps
* Pregnancy
* Life expectancy below 7 days or acute palliative care situation
* Death inevitable or maximum therapy is not carried out by the treating physicians or due to patient's request
* Unable to understand the official language
* ICU stay \> 72h at the time of enrolment

Translated with www.DeepL.com/Translator (free version)