cyrilzakka/clinical-trials huggingface dataset:
Cathartic-Free DECT Colonography for Detection of Colonic Polyps

Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation.

Determine the feasibility to differentiate polyps from stool with or without the use of contrast agents and to assess the feasibility and accuracy of dual energy techniques in a pilot patient study.

1.1 Formulate algorithms that use dual-energy information to quantitatively measure specific material density of colon polyps in physics based simulation.

1.2 Determine optimal scanning parameters on prototype CT equipment.

2.1 Measure the material composition density and Hounsfield number of polyps with and without simulated contrast enhancement.

2.2 Measure the accuracy of dual-energy techniques to differentiate between polyps and stool and if needed using a combination of simulated intravenous enhanced polyps and contrast material tagged stool.

3.0 Asses the clinical performance of dual-energy CTC for the detection of larger polyps 1 cm or larger without cathartic preparation.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a known colorectal polyp or colon carcinoma with pathology, at or greater than 1 cm in size on a colonoscopy that is completed either eight weeks before or after CT Colonography study visit.
* If receiving iodine oral or IV contrast, must have a creatinine less than 1.4 on record within last 30 days of study visit date. If no creatinine is available, one will be drawn for enrollment criteria purposes.

Exclusion Criteria:

* Pregnant females.
* Presence of colostomy or right hemicolectomy.
* Inflammatory bowel disease (Crohn's, chronic ulcerative colitis).
* Familial polyposis syndrome.
* Pregnant female.
* Creatinine at or greater than 1.4
* Severe or uncontrolled chronic obstructive pulmonary disease (COPD) or chronic obstructive lung disease (COLD).
* Iodine contrast allergy.
IV Iron-induced Hypophosphatemia After RYGB

The primary objective of the study is to compare the incidence of hypophosphatemia in RYGB patients treated with intravenous (IV) single dose of iron isomaltoside (Monofer®) or ferric carboxymaltose (Ferinject®).


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Signed informed consent
* Patients with previous RYGB surgery performed \> 12 months ago
* Failed response to oral iron supplementation
* Established diagnosis of iron deficiency by ferritin \< 50 ug/l or serum ferritin ≤100ug/l and low transferrin saturation (TSAT) ≤ 30%
* Normal phosphate blood level (0.8 - 1.45 mmol/l) before infusion
* Normal magnesium blood level (0.65-1.05 mmol/l)
* Outpatient

Exclusion Criteria:

* - Patients with known hypersensitivity to iron preparation and/or anaphylaxis from any cause
* Patients for whom a treatment with one of the IV iron is contra-indicated (based on product summary of product characteristics)
* Women who are pregnant or breastfeeding
* Intention to become pregnant during the course of the study
* Renal failure, chronic kidney disease stage 3b or worse (eGFR ≤ 45 ml/min/1.73m2)
* Patients who received IV iron infusion during the last 3 months before screening
* Treatment with erythropoietin or erythropoietin-stimulation agents, red blood cell transfusion within the last 3 months prior to screening
* Alcohol or drug abuse within the past 6 months
* Planned surgical procedure within the clinical trial period
* Surgery under general anaesthesia within the last 3 months prior to screening
* Hyperparathyroidism
* Kidney transplantation
* Inability to follow study procedures or give informed consent
* Use and inability to stop from V0 to study end, phosphate supplementation (except daily multivitamin preparation recommended after bariatric surgery; the exact amount of phosphate and iron supplementation in the daily multivitamin will be recorded)
* Osteoporosis drug therapy (bisphosphonates, denosumab or selective oestrogen receptor modulators).
* Patient who refuses to be informed of incidental discoveries that may contribute to the prevention, diagnosis, and treatment of existing or probable future illnesses.
Effect of Early Assessment Team for Patients Referred to Outpatient Mental Health Care

Loss of function and incapacity for work as a result of mental disorders are increasing, especially among young people (under 30 years of age), even though the prevalence of mental illness is fairly stable. Many of the patients referred to outpatient mental health care have complex difficulties with both mental and somatic ailments, in addition to difficulties with social conditions related to, for example, education, work, finances and social support. Functional difficulties can come as a result of mental illness. However, it can also be the opposite way; not functioning at work, study or daily life in general can cause mental symptoms and ailments. Many of these people are referred to mental health care even if the basic problem cannot be solved by psychotherapy or medication. Some of the referred patients do not have a psychiatric illness, but a reaction to a stressful and demanding situation and strains over time. Compound health challenges require individualized assessments and clarifications in order to offer the right measures. Traditionally in mental health care, the patient is placed on a waiting list to receive assessment and therapy for a specific condition.

With this background, the investigators believe it is important to early identify the referred patients who will benefit from measures other than traditional assessment and treatment in mental health care. Knowledge of other aid agencies is important to find the right measures at the right time. This is important for the individual patients, who are often young people going to "get started in life". It is also important for the health services because the capacity to provide a good health service is a limited resource. From a societal perspective it is important that the health care offered contributes to reducing social security dependence.

The purpose of this randomized, controlled trial is to compare the effect of traditional management of newly referred patients in outpatient clinics with assessment through an Early Assessment Team. The investigators believe that early assessment may have a positive effect on mental health, quality of life and function. The outcome goals can be summarized as less use of resources in outpatient clinics and society and better function and life for patients.


Eligibility Criteria:
Inclusion Criteria:

* all patients referred to a general psychiatric outpatient clinic
* necessary capacity to consent
* master Norwegian language to such an extent that the patient can understand the written consent

Exclusion Criteria:

* patients that an admission team at the outpatient clinic consider obviously must have a TAU for some time
* patients too healthy to receive specialized mental health care
* patients in need of acute psychiatric assessment
* relevant participants who do not respond digitally or who do not confirm consent in writing within given deadlines
IL-4(38-37)-PE38KDEL Immunotoxin in Treating Patients With Recurrent Malignant Astrocytoma

RATIONALE: IL-4(38-37)-PE38KDEL immunotoxin may locate tumor cells and kill them without harming normal cells. This may be an effective treatment for recurrent malignant astrocytoma.

PURPOSE: Phase I trial to study the effectiveness of IL-4(38-37)-PE38KDEL immunotoxin in treating patients who have recurrent malignant astrocytoma.

OBJECTIVES: I. Determine the maximum tolerated dose of intratumorally infused IL-4(38-37)-PE38KDEL immunotoxin in patients with recurrent malignant astrocytoma. II. Determine the safety of this regimen in these patients. III. Determine preliminarily any efficacy of this regimen in these patients.

OUTLINE: This is a dose escalation, multicenter study. Patients undergo a stereotactic biopsy under MR/CT guidance. Catheters are then placed into the tumor under stereotactic guidance. The catheter is filled with IL-4(38-37)-PE38KDEL immunotoxin (IL-4 toxin), with infusion beginning 24 hours after catheter insertion. The IL-4 toxin is infused over 4 days. The catheter is removed 45 minutes after the infusion is completed and a MR scan is performed. Cohorts of 3 patients each receive escalating doses of IL-4 toxin until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose preceding the dose at which 2 of 3 patients experience dose limiting toxicity. Patients are followed every 4 weeks for 16 weeks, then every 8 weeks for up to 3 years.

PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent glioblastoma or anaplastic astrocytoma Stereotactically accessible, enhancing mass no greater than 50 mL total volume by MRI No significant mass effect Recent craniotomy allowed No anaplastic oligodendroglioma No tumors of the brainstem, cerebellum, or both hemispheres No diffuse subependymal or CSF disease If on stable or increasing dose of steroid, must have evidence of increasing contrast enhancement by MRI or CT scan Prior external beam radiotherapy required

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9.5 g/dL Hepatic: Bilirubin less than 2 mg/dL AST and ALT less than 2 times upper limit of normal (ULN) PT/PTT no greater than ULN Renal: Creatinine less than 2 mg/dL Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No systemic diseases to cause unacceptable anesthetic/operative risk No active infection requiring treatment No unexplained febrile illness

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent blood or platelet transfusions Chemotherapy: At least 4 weeks since prior chemotherapy Endocrine therapy: See Disease Characteristics Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Medically able to undergo surgery Other: No other concurrent investigational agents
Study of Virtual Reality Therapy and Cognitive Behavior Therapy in Panic Disorder With Agoraphobia

The study aims at comparing virtual reality therapy (VRT) with a usual cognitive behavior therapy (CBT) program for agoraphobia. A waiting list represents the control condition. The investigators' purpose is to test a pure VRT compared with a pure CBT, as previous works suggest that the combination of the two methods are clinically effective. Patients receive a two-page information leaflet about the trial and sign an informed consent. After the first evaluation, they are randomized, in three centers (Lyon, Paris, Luxemburg), either to VRT (12 sessions) or CBT (12 sessions), or a waiting-list control condition for three months. After three months the waiting list is randomized to VRT or CBT. The follow-up is one year from entry into the active part of the trial.


Eligibility Criteria:
Inclusion Criteria:

* The study includes 90 patients, aged from 18 to 60, with DSM-4 panic disorder with agoraphobia.
* Patients should not be clinically depressed and present a Hamilton Scale of Depression score of less than 18.

Exclusion Criteria:

* Patients with active medication (antidepressants, neuroleptics, mood stabilizers, benzodiazepines, Kava Kava, or hypericum) or street drugs. Minor herbal medicine is tolerated.
Safety, Tolerability, and Pharmacokinetics of Multiple Rising Doses of BI 425809 Tablets for 12 Days to Young and Elderly Healthy Male and Female Volunteers and Comparison of Pharmacokinetics of a Single Oral Dose of BI 425809 (Morning Versus Evening)

The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the evening.


Eligibility Criteria:
Inclusion criteria:

* Healthy male or female subjects according to the investigator´s assessment, based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), 12-lead electrocardiogram (ECG), and clinical laboratory tests
* age of 18 to 50 years (incl.) for young healthy volunteers or age of 65 to 80 years (incl.) for elderly healthy volunteers
* Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with good clinical practice (GCP) and local legislation
* Female subjects who meet any of the following criteria:

  1. Surgically sterilised
  2. Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

Exclusion criteria:

* Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg in young subjects, and systolic blood pressure greater than 150 mmHg, diastolic blood pressure greater than 95 mmHg in elderly subjects, or pulse rate outside the range of 50 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* History of relevant orthostatic hypotension, fainting spells, or blackouts
* Chronic or relevant acute infections
* Further exclusion criteria may apply
Cohort B of the Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter

A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions


Eligibility Criteria:
Inclusion Criteria:

* Adult aged 25-80
* Patient understands and has signed the study informed consent form
* Patient has an angiographic documented Chronic Total Occlusion (i.e. \>3 months occlusion duration) showing distal TIMI flow 0, with a reference diameter of at least 2 millimeters.
* Left ventricle ejection fraction \> 25%

Exclusion Criteria:

* Patient unable to give informed consent.
* Elevated CK-MB or troponin at baseline
* Patient is known or suspected not to tolerate the contrast agent
* Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion
* Appearance of a fresh thrombus or intraluminal filling defects
* Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor)
* Cardiac intervention within 4 weeks of the procedure
* Severe renal insufficiency with eGFR\<30 ml/min/1.72 m2
* Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV
* Life expectancy \< 2 years due to other illnesses
* Acute or unstable medical disorder/disease that may cause a risk to patient, including:

  i. Recent myocardial infarction (MI) (within the past two weeks) ii. Significant anemia (e.g. hemoglobin \< 8.0 mg / dl) iii. Recent major cerebrovascular event (history of stroke or TIA within 1 month) iv. Severe uncontrolled systemic hypertension (e.g., \>180/100 mmHg) v. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
Investigation of a Novel Silicone Dressing to Maximize the Outcomes of Scar Revision Procedures (IMPROVE)

Neodyne has developed an investigational dressing for post-operative incision care. Neodyne is conducting this research to study whether the investigational dressing, called the Neodyne Dressing, can minimize scar formation in a simple manner.

It is proposed to study a dressing designed to reduce the appearance of scars after scar revision surgery. It is expected that by managing the incision site after primary closure but during the longer term healing phase, scar formation may be minimized.

Eligibility Criteria:
Inclusion Criteria:

* The scar to be revised is:

  * at least 12 months old
  * linear and suitable for revision by excision and direct closure
  * appropriate size and location for Neodyne Dressing
* The subject:

  * age \> 18 and \< 65 years old

Exclusion Criteria:

* Subjects with a skin disorder that is chronic or currently active.
* Subjects who are involved in ongoing litigation in connection with the scar to be revised.
* Subjects with a history of collagen vascular disease
* Subjects diagnosed with scleroderma
* Subject who currently smokes
* Subjects with known adverse reactions to steri-strip tapes, medical tapes, or adhesives
* Subjects with oozing, dehiscence, non-closed/healed incisions at time of first application.
* Subjects with inability to maintain adequate care of incision.
Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Correction for Low Toric Lens Correction in Cataract Surgery

Examination of the accuracy of toric predictive power in patients with 1.5 diopters of astigmatism or less.

Based on preoperative keratometry and using the Baylor Nomogram and a standard factor for surgically-induced astigmatism, the investigators will calculate "keratometry-based total astigmatism" for each patient. This will be compared to "aberrometry-based total astigmatism", i.e. the total astigmatism measured by ORA in each case. With this information the investigators will determine in what portion of patients keratometry-based total astigmatism vs aberrometry-based total astigmatism predicts a need for astigmatism correction, (i.e., total astigmatism is greater than or equal to 0.5 D) during cataract surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent conventional (non-femtosecond) cataract surgery and whose "data to be collected" are accessible and available from the ORA database.
* Patients whose medical records show they did not exhibit any significant ocular morbidity that would be expected to influence outcome measures.

Exclusion Criteria:

* Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their visual outcome or ability to be refracted after.
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
* Patients with previous refractive surgery.
Effectiveness of Ultrasound Combine TENS in Treatment of Upper Trapezius Myofascial Pain

To assess the effectiveness of therapeutic ultrasound combine transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound in treatment of myofascial pain syndrome in upper trapezius muscle measured by mean change between pre and post treatment of pressure pain threshold (PPT), patient's complaint in pain intensity and the number of total tablet usage of acetaminophen in both groups.

Myofascial pain syndrome (MPS) is one of the most common causes of musculoskeletal pain and can affect any skeletal muscles in the body.Myofascial pain is not fatal condition but it can significant reduced quality of life and is a major cause of time lost from work. There are various treatments, which divided into invasive and non-invasive therapies. In the recent clinical practice, there is a new type of combine treatment unit which composes of electrotherapy and ultrasound therapy in one unit. However, there is no conclusive evidence for supports the effectiveness of this combine therapy compare with the conventional ultrasound in treatment of myofascial pain especially in aspect of pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 years old
* Clinical diagnosis of myofascial trigger point pain at upper trapezius muscle(s) persisted more than 1 week but less than 6 months before recruitment time, first or recurrence episodes
* Baseline VAS more than or equal 4 at upper trapezius muscle

Exclusion Criteria:

* During the past 2 weeks had received injection or physical therapy at upper trapezius muscle or shoulder area
* Had experience of ultrasound combine transcutaneous electrical nerve stimulation (TENS)
* Had history of accidence or severe trauma to shoulder region
* Had serious musculoskeletal condition that need surgical intervention such as acute shoulder subluxation, abnormal neurological examination
* Insensate skin or sensory impairment around shoulder area
* Skin infection at shoulder area
* Had contraindication for U/S such as cardiac pacemaker, implantation, malignancy in relevant area, bleeding disorder, acute inflammatory musculoskeletal disease, pregnancy, lactation
* Unable to communication
* Unable to complete treatment session and follow protocol
Factors Analysis Related to Prolonged Stay in the Pediatric Post-Anesthesia Care Unit(PACU)

The purpose of this study is to determine which factors contribute to prolonged stay of children in the PACU.

Studying the factors associated with prolonged stay of children in the PACU is of great significance to the medical team, as it can improve the quality and speed of anesthesia recovery, not only in line with the concept of accelerated rehabilitation surgery, but also through intervention and optimization of specific factors to improve the efficiency of children's postoperative discharge from the PACU, reduce the incidence of complications, lower medical costs, and increase patient and family satisfaction. Therefore, this study aims to explore the factors associated with prolonged stay of children in the PACU through retrospective analysis.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 0-18 years old; Child entering the Pediatric Post-Anesthesia Care.
* Emergency surgery; Pediatric patients with incomplete medical history; Pediatric patients requiring postoperative ICU care; Pediatric patients with preoperative altered consciousness; Neurological disorders; Severe liver, kidney, lung, and heart diseases.