cyrilzakka/clinical-trials huggingface dataset:
High Resolution Optical Coherence Tomography

Comparison of high-resolution optical coherence tomography (High-Res-OCT) to conventional imaging modalities for the diagnosis of eye diseases

The high resolution optical coherence tomography (High-Res-OCT) is an improvement of a non-invasive routinely used imaging technique, the optical coherence tomography (OCT), with a light-source capable of providing an increased axial resolution. The routinely used Spectral-Domain OCT has a center wavelength of 880 nm and a spectral bandwidth of 40 nm, resulting in an axial resolution of approximately 7 μm in the eye and is used routinely worldwide. The High-Res OCT works with a central wavelength of 840 nm and an increased bandwidth of 130 nm, making it possible to improve the optical axial resolution in tissue from 7 to 3 µm, without increasing the maximum laser exposure limit. The improved axial resolution of the High-Res OCT results in clearer and more detailed images. The technique is routinely used in clinical practice and the device used for High-Res-OCT (Heidelberg, SPECTRALIS® High-Res OCT- DMR001) has received CE mark (european conformity in the extended Single Market in the European Economic Area) approval in March 2021. We plan to compare High-Res-OCT as an imaging modality to conventional imaging modalities used in clinical routine, such as the Spectral-Domain-OCT (SD-OCT)

Eligibility Criteria:
Inclusion Criteria:

* Patients from the Department of Ophthalmology, University Hospital Bern requiring conventional imaging for eye disease and willing to sign informed consent Patients of 18 years or older

Exclusion Criteria:

* Patients not willing or able to sign informed consent
* Patients younger than 18 years
* Patients with epilepsy.
* Vulnerable subjects (except the objectives of the investigation concern vulnerable subjects specifically),
* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation
* Enrolment of the PI, his/her family members, employees and other dependent persons
Studying DNA in Tissue Samples From Caucasian and African-American Cancer Patients Who Received Docetaxel on Clinical Trial CLB-9871

This research trial studies deoxyribonucleic acid (DNA) in blood samples from Caucasian and African-American cancer patients who received docetaxel on clinical trial CLB-9871. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about how docetaxel is used by the body.

PRIMARY OBJECTIVES:

I. To determine the genotype of ATP-binding cassette, sub-family C (CFTR/MRP), member 2 (ABCC2) and solute carrier organic anion transporter family, member 1B3 (SLCO1B3) (and other genes potentially relevant in the pharmacokinetics and pharmacodynamics of docetaxel in the future) in Caucasian and African-American cancer patients enrolled on clinical trial CLB-9871.

II. Explore the relationships between these genotypes and docetaxel pharmacokinetic parameters (e.g., area under curve \[AUC\], steady-state volume of distribution \[Vdss\]).

OUTLINE:

Blood samples collected on clinical trial CLB-9871 are examined via ABCC2 and SLC01B3 genotyping using TaqMan analysis. Other genes related to the pharmacokinetics and side effects of docetaxel may be considered for future genotyping. In some cases, panels of drug response single nucleotide polymorphisms (SNPs) on high-density arrays may be genotyped.

Eligibility Criteria:
* Registration to CALGB 9871
* Samples present within the CALGB Pathology Coordinating Office that are sufficient to meet study aims
Comparison of Bimatoprost Sustained Release (SR) to Selective Laser Trabeculoplasty (SLT) in Adults With Open-Angle Glaucoma or Ocular Hypertension

This study will evaluate the intraocular pressure (IOP)-lowering effect and safety of bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (e.g., due to intolerance or nonadherence).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of either open-angle glaucoma or ocular hypertension in each eye that require IOP lowering treatment.
* In the investigator's opinion, patient's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
* In the investigator's opinion, both eyes can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog eye drops as the sole therapy if medication was taken as directed, or with SLT monotherapy.

Exclusion Criteria:

* History of previous laser trabeculoplasty
* History or evidence of complicated cataract surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant \[IOL\], sulcus IOL, aphakia, etc) or intraoperative complications (such as a posterior capsular tear \[with or without vitreous loss\], substantial iris trauma, etc) or history of phakic IOL insertion for refractive error correction
* Intraocular surgery (including cataract surgery) and/or any ocular laser surgery within the 6 months prior to treatment
* Previous use of commercially available Bimatoprost SR; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.
Does Nicotine Influence the Risk of Preeclampsia?

This prospective cohort study explores the long-term impact of pre-pregnancy smoking on vascular health in women predisposed to preeclampsia, conducted at the Medical University of Graz. The study specifically targets women at high risk for preeclampsia who are taking aspirin as a preventative measure.

The main question it aims to answer is:

Does smoking before pregnancy influence the development and severity of preeclampsia and its associated vascular changes in high-risk women?

Participants, divided into former smokers and non-smokers, underwent comprehensive assessments throughout their pregnancies. Measurements included hemodynamic parameters such as heart rate and blood pressure, assessed with an upper arm cuff, and arterial stiffness, evaluated using pulse wave velocity with the Vicorder device. Retinal microvasculature was examined through digital imaging, and the vascular health marker ADMA, nicotine exposure marker cotinine, blood pressure regulatory enzyme neprilysin, and cellular aging indicator telomere length were quantified from blood samples. Cortisol levels were also measured from hair samples to assess stress responses.

The investigators collected extensive data on each participant, including age, BMI (body mass index), and medical history, to understand their baseline health. Routine laboratory tests were conducted to monitor the health status throughout the pregnancy. Preeclampsia biomarkers and Doppler ultrasound examinations of the uterine and umbilical arteries to assess fetal and placental blood flow were conducted. The investigators tracked the development of preeclampsia, gestational hypertension (GH), and gestational diabetes mellitus (GDM).

Outcomes for the babies, such as birth weight, delivery method, gender, and the gestational week at delivery, were meticulously recorded to evaluate the broader impacts of maternal smoking and vascular health on neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* a positive preeclampsia screening or a history of preeclampsia, daily intake of 150mg aspirin , and age over 18 years

Exclusion Criteria:

* twin pregnancies, fetal anomalies, maternal chronic renal diseases and discontinued aspirin intake.
Evaluation of the Reproducibility of Jumping Mechanography

Sarcopenia, the age-related decline in muscle mass and function (widely recognized as "frailty"), is increasingly being appreciated, primarily in the research environment. Interventions to prevent or treat sarcopenia can be anticipated to reduce falls, fractures and thereby to facilitate independence and improve quality of life for older adults. Unfortunately, there is no current consensus definition of sarcopenia, thereby impeding clinical recognition and treatment. It has been advocated that low appendicular (arm and leg) lean mass, as measured by DXA, be utilized as a clinical diagnostic tool to define sarcopenia. While such an approach is possible, however, muscle strength loss is more rapid than mass loss, indicating deterioration of muscle "quality." Muscle quality may be affected by changes at the neuromuscular, cellular or subcellular levels; parameters not detected by measuring mass alone. Clearly, tools evaluating muscle performance, not simply mass, are needed to optimally identify, and subsequently monitor, treatment of older adults with sarcopenia. While current tests of muscle power/function (e.g., chair-rising, self-selected gait velocity, etc.) do correlate with functional limitation in older adults, these existing tests have limitations in that they cannot be performed in all people, may have "yes/no" results rather than a continuous scale and may not be highly precise. Thus, improved muscle function assessment tools are needed, both clinically and in research venues. Jumping mechanography is very likely one such methodology.


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory, community dwelling men and women age ≥ 70 years
* Able and willing to sign informed consent
* Able to stand without assistance

Exclusion Criteria:

* Abnormalities on screening laboratory assessment deemed to be clinically significant by the study investigators
* History of myocardial infarction within the prior six months or ongoing angina
* History of injury or surgery within the prior six months which limits the ability to ambulate
* History of severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which might limit the ability to complete this study
* History of malignancy with metastasis to the musculoskeletal system
* Neuromuscular disease impairing balance to the degree of not being able to stand without assistance
* BMD T-score of less than -3.5 at any measured site and a prior hip or vertebral fracture
Perfusion Magnetic Resonance Imaging in Measuring the Growth of Blood Vessels in Newly Diagnosed Brain Tumors

RATIONALE: Perfusion magnetic resonance imaging may be an effective method of measuring the growth of blood vessels in brain tumors. These measurements may help doctors better diagnose and treat brain tumors.

PURPOSE: Pilot study to determine the effectiveness of perfusion magnetic resonance imaging in measuring the growth of blood vessels in newly diagnosed brain tumors.

OBJECTIVES: I. Correlate the findings of perfusion magnetic resonance imaging with known tissue and serum markers of angiogenesis in patients with newly diagnosed surgically resectable brain tumors.

OUTLINE: Patients undergo perfusion magnetic resonance imaging (MRI) scanning with contrast in conjunction with preoperative conventional MRI scanning with contrast. Patients receive gadopentetate dimeglumine IV over 5 seconds prior to perfusion MRI. Gadopentetate dimeglumine is administered at a slower rate prior to conventional MRI. Patients undergo blood draw to determine urokinase type plasminogen activator levels. After completion of perfusion and conventional MRI scanning, brain tumor tissue samples are obtained during surgical resection to determine tumor grade and type and urokinase type plasminogen activator and basic fibroblast growth factor levels. If CSF removal is required during surgery, then CSF samples are collected to determine urokinase type plasminogen activator and basic fibroblast growth factor levels.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Newly diagnosed surgically resectable brain tumor

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Able to tolerate gadopentetate dimeglumine contrast Medically stable

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics
Water-aided Colonoscopy in Inflammatory Bowel Disease Patients

Water-aided insertion of the colonoscope has been repeatedly proven to beneficial in terms of lower discomfort and need for sedation during colonoscopy. Patients with inflammatory bowel diseases (IBD) undergo repeated colonoscopy in course of their disease. According to our preliminary experience, water immersion could be beneficial while scoping these patients. As far as the investigators know, water-aided colonoscopy has never been studied in this indication. Results of our trial might support use of water-aided colonoscopy in common practice and decrease associated discomfort in IBD patients.


Eligibility Criteria:
Inclusion Criteria:

* known diagnosis of inflammatory bowel disease
* planned diagnostic outpatient colonoscopy
* signed informed consent
* willingness to undergo unsedated colonoscopy

Exclusion Criteria:

* ulcerative proctitis
* bowel resection longer than ileocecal resection
* requirement for sedation
Effectiveness Study of Hylan G-F 20 to Preserve Cartilage in Osteoarthritis of the Knee

That Hylan G-F 20 may act to protect cartilage from the expected degree of degradation over a 12 month period in subjects with moderate to marked osteoarthritis of the knee

Two courses of Hylan G-F 20 ( Synvisc) administered by intra-articular injection at 6 monthly intervals. MRI examinations of the knee for estimation of cartilage volume prior to treatment, before second course and at 12 months in 40 subjects with Grade 2/3 osteoarthritis of knee . A further 40 subjects with similar degree of osteoarthritis of knee who do not receive Hylan G-F therapy will be assessed by MRI in identical manner.

Eligibility Criteria:
Inclusion Criteria:

* grade 2 or 3 osteoarthritis knee age 18 - 80 pain score VAS \>39 mm on 100mm scale

Exclusion Criteria:

* surgery in prior 12 months significant valgus deformity recent trauma use of opioid analgesia unstable medical condition recent corticosteroid injection morbid obesity
Pulmonary Nodule Cohort

The aim of this study is to identify the clinical features of pulmonary nodules and establish a cohort to identify biomarkers for lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* age \>= 18
* pulmonary nodule(s) on chest CT, which satisfy at least one of the following two criteria,

  * 4A or above in Lung-RADS v1.1
  * lung cancer risk \>= 5% in Brock model

Exclusion Criteria:

* already proven lung cancer
The Effect of Fat Mass, Fat-free Mass and Resting Metabolic Rate on Energy Intake

The present study was based on secondary analysis using the non-intervention control conditions of five separate studies with common measures. The current analysis examine the indirect and direct effects of fat-free mass, fat mass and resting metabolic rate on energy intake in individuals at or close to energy balance.

The current analysis examine the indirect and direct effects of fat-free mass, fat mass and resting metabolic rate on energy intake in individuals at or close to energy balance.

The present study was based on secondary analysis using the non-intervention control conditions of five separate studies conducted between the dates of 1998 and 2007. In total, 242 subjects (114 males; 128 females; mean body mass index = 25.6 ± 5.0 kg/m2) were included. In these studies, body composition (air displacement plethysmography), energy expenditure (indirect calorimetry and flex heart rate) and energy intake (weighed dietary records) were measured using common procedures.

Eligibility Criteria:
Inclusion Criteria:

* Weight stable (weight change of \<2 kg in the previous three months)
* Non smoker
* Not dieting,
* No history of eating disorders,
* Free from disease

Exclusion Criteria:

* Taking medication known to effect metabolism or appetite
* Pregnant
The ARCTIC Trial: Aerosolized Inhaled Adenosine Treatment in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by COVID-19

This is a phase II study to test adenosine efficacy for down-regulation of the overwhelming inflammation of COVID-19 in the lungs as reflected by clinical recovery of lung function; resolution of clinically relevant markers of lung function, and resolution of systemic markers of inflammation and coagulation.


Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old) male and female patients with diagnosed COVID-19 respiratory infection, verified by culture/swab RNA. Impending ARDS respiratory collapse with progressive increasing oxygen requirements, and in line with sub-study as defined below.
* Patients intubated within the prior 24 hours.
* Hemodynamically stable (not requiring vasopressors or catecholamine agents to support systemic blood pressure; no existing shock defined as BP \< 100 mmHg systolic).
* In-place continuous arterial line for blood sampling.

Exclusion Criteria:

* Younger than 18 years old.
* Prisoners
* Pregnant women.
* Unable to obtain next of kin consent.
* End-stage cardiac disease with COVID-19.
* Non COVID-related causes of ARDS/respiratory failure, septic shock, or post trauma shock, respiratory failure after blood transfusion or surgery.
* Unstable asthma or history of frequent/poorly controlled asthmatic attacks.
* Not expected to live more than 6 months due to underlying condition such as cancer.
Absorption, Metabolism, Excretion and Absolute Bioavailability of EDG-5506 in Healthy Volunteers

This is a Phase 1 2-part, single-center, open-label study in healthy male volunteers. Part A will assess the absorption, metabolism, excretion, and pharmacokinetics of one oral dose of radiolabeled EDG-5506. Part B will assess bioavailability of EDG-5506 with a single oral dose of EDG-5506 and a single intravenous dose of radiolabeled EDG-5506.

This is a Phase 1 2-part, single-center, open-label study.

Up to 15 (8 in Part A and 7 in Part B) healthy male subjects will be enrolled in the study.

Part A:

Potential subjects will be screened to assess eligibility within 28 days prior to dose administration. Subjects will be admitted on Day -1 and confined to the study site until at least Day 30. On Day 1, subjects will receive a single oral suspension. Blood, urine and feces samples will be collected for determination of EDG-5506 concentration, total radioactivity, and metabolite profiling and identification. Between Day 30 and Day 36, subjects will be discharged.

Part B:

Potential subjects will be screened to assess their eligibility within 42 days prior to dose administration. Subjects will be admitted on Day -1 and confined to the study site until Day 8. On Day 1, subjects will receive a single oral dose of EDG-5506 in the fasted state followed 2 hours later by a single dose of radiolabeled EDG-5506. Subjects will be discharged from the study site on Day 8. Blood samples will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. For both Part A and Part B, males, of any race, between 18 and 55 years of age, inclusive.
2. For both Part A and Part B, a body mass index between 18.0 and 32.0 kg/m2, inclusive, and a total body weight greater than or equal to 50 kg.
3. In good health, determined by no clinically significant findings from medical history, 12-lead electrocardiogram, vital signs measurements, and clinical laboratory evaluations at screening and check-in.

Exclusion Criteria:

1. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, genitourinary, immunological, or psychiatric disorder, as determined by the investigator (or designee).
2. Participation in a clinical study involving administration of an investigational drug in the past 30 days or 5 half-lives (whichever is longer) prior to dosing.
3. Participation in more than 3 radiolabeled drug studies in the last 12 months.
4. Poor peripheral venous access.
5. Subjects with exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
Comparative Study of Laparoscopic Versus Open Appendectomy in Children

The study intends to compare the results of two surgical methods to remove the appendix in children with appendicitis. Specifically, up to 500 children over 3 years will be placed in two groups where the only difference in treatment is open or laparoscopic (scope) operation. Each group will be tracked for their baseline characteristics, events during operation and recovery, pain medication requirements, duration of hospital stay, and patient/family satisfaction.

The investigators hypothesize that their will be no difference in the parameters measured between the techniques of appendix removal.


Eligibility Criteria:
Inclusion Criteria:

* All children under the age of 18 years with diagnosed appendicitis

Exclusion Criteria:

* Refusal of consent
* Primary language other than English or Spanish.
Specific Immunotherapy for Allergic Child

The recent interest that the Specific Immunotherapy (ITS) has aroused is due to the positive potential role that could be played, in particular in the forms of allergic asthma, because this method constitute the only intervention (unlike that pharmacologic) able to act on the same causes of the disease, altering the natural history. To achieve this the investigator has tried to use the specific subcutaneous immunotherapy (SCIT), to which there are studies that, with scientific rigor, have demonstrated the benefits.

The Investigator proposes to compare, in children with allergic rhinitis and / or allergic asthma to grasses, the pain caused by the administration of the Specific Immunotherapy (ITS) via epicutaneous with autoinjector (INJEX) pressure without needle vs. the traditional subcutaneous immunotherapy (SCIT).

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from both parents / legal guardian;
* Of both sexes;
* Between the ages of 5 to 18 sensitized to grasses Awareness for grasses will be established with prick test;
* Rhinitis established according to the ARIA (Allergic Rhinitis and its Impact on Asthma) guidelines and / or stage 1 or 2 Asthma according to GINA classification (Global Initiative for Asthma)
* It may, or not, be going on ITS with s.c. administration

Exclusion Criteria:

* Children under age 5 and age\> 18 years;
* Autoimmune diseases and immunodeficiencies;
* Neoplasms;
* Severe psychological problems;
* Treatment with β-blockers;
* Poor compliance, including language training;
* Severe asthma uncontrolled by medication or irreversible airway obstruction (FEV1 less than 70% of the predicted value);
* Severe cardiovascular diseases in which may be hazardous in the administration of adrenaline