cyrilzakka/clinical-trials huggingface dataset:
Endocuff-assisted vs. Standard Colonoscopy

The aim of this study is to evaluate Endocuff- assisted colonoscopy in terms of its possible additive contribution in the detection of important lesions, namely polyps and cancers, compared to standard colonoscopy, in a series of patients undergoing back-to-back screening or surveillance colonoscopies in a randomized fashion. Moreover, we aim to assess possible changes regarding post-polypectomy surveillance programs following Endocuff utilization.

Tandem colonoscopies studies results, show that novel endoscopic technologies detect about 20% more adenomas than those conventional colonoscopy does (missed adenomas). Since Endocuff-assisted colonoscopy cannot be considered as a perfect examination, we hypothesize that conventional colonoscopy will detect one third of the missed adenomas that Endocuff-assisted colonoscopy detects in a similar setting. Therefore a sample size of 120 adenomas achieves 80% power to detect an odds ratio of 3.0 using a two-sided McNemar test with a significance level of 0.05. The odds ratio is equivalent to a difference between two paired proportions of 14% which occurs when the proportion of detected missed adenomas during Endocuff-assisted colonoscopy is 21% and the proportion of missed adenomas during conventional colonoscopy is 7%. During one year period before the study initiation, our colonoscopy performance quality data show that we detect a mean number of adenomas per patient equal of 0.7 in a population similar to the one recruited in our study. Therefore, 172 patients overall will be required to detect 120 adenomas. Given the uncertainty of our estimation and in order to cope with patients exclusions, withdrawals and unexpected incomplete colonoscopies, we decided to recruit 200 patients.

A more extensive description regarding the investigators study is provided in the following fields.

Eligibility Criteria:
Inclusion Criteria:

* adults undergoing elective screening or surveillance colonoscopy
* symptomatic adults with indication for colonoscopy

Exclusion Criteria:

* age\<18 and \> 80 years
* poor overall health (ASA III, IV)
* recent abdominal surgery
* presence of abdominal wall hernias
* active colitis
* previous bowel resection
* inflammatory bowel disease
* polyposis syndromes
Investigational Drug Versus an Approved Drug in Patients With Osteoarthritis (0663-061)(COMPLETED)

The purpose of this study is to compare the gastrointestinal tolerability of an investigational drug to an approved drug in the treatment of osteoarthritis during one year treatment period.

The duration of treatment is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee, hip, hand or spine which requires the use of medications for pain relief

Exclusion Criteria:

* Known allergies to the study drugs
Molecular Diagnosis and Risk Stratification of Sepsis

Background: Sepsis is a major cause of in-hospital morbidity and mortality. Current tools available to the clinician to initiate therapy of patients with sepsis mainly comprise of symptom classification systems and culture techniques, which provide aspecific and slow information.

Objective: The ultimate goal of this program is to assist the physician at the bedside in tailoring the treatment of an individual patient suffering from sepsis by generating rapid molecular information about the causative pathogen and the host response.

Deliverables: Rapid tests ("sample-in-result-out") that can be used by health care personnel at or close to the bedside and that provide rapid information (within two hours) about the presence or absence of sepsis, the causative pathogen and the risk of the individual patient for sepsis complications and death.

Design: The program is organized into four Work Packages (WPs) along a clinical, discovery and technology platform. In WP1 two university hospitals will enroll 7500 patients admitted to the Intensive Care Unit during the first 3 years of the project; 25% - 40% of these patients will have or will develop sepsis. In WP2 (Pathogen Detection), blood obtained from these patients will be used to develop rapid, fully automated DNA-based bedside tests that identify microorganisms and also provide information about their resistance to antibiotics. In WP3 (Host Response), RNA from blood cells will be analyzed to find novel biomarkers and to develop rapid and easy to perform tests that provide information about the risk profile of the patient. In addition, plasma levels of selected protein biomarkers will be measured for comparison of their value with that of the identified leukocyte molecular signatures. WP4 is responsible for the ICT management of the project. The Clinical Platform (covered by WP1 and WP4) delivers patient data and biological samples to the discovery and technology platforms. The Discovery Platform (covered by WP2 and WP3) uses patient data and biological samples to develop tests for detection of the infectious agent causing sepsis and for stratification of patients according to their risk for sepsis complications, including death. The results generated within the discovery platform will be delivered to the technology platform. The Technology Platform (part of WP2 and WP3) has the specific aim to develop rapid assays that run on a fully automated (micro)fluidics platform that is so easy to operate that it can be used in decentralized settings such as (close to) the ICU. The developed assays will make use of the knowledge generated in the discovery platform.


Eligibility Criteria:
Inclusion Criteria:

* All patients\> 18 years in the Intensive Care Units of the AMC Amsterdam and UMC Utrecht.

Exclusion Criteria:

* Elective cardiac surgery patients with an uncomplicated stay.
A Study Investigating the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Olamkicept in Healthy Persons

Interleukin (IL)-6 is a cytokine produced in response to infection and tissue damage. IL-6 is believed to act as a key mediator in chronic inflammation and autoimmune diseases such as inflammatory bowel diseases. IL-6 is known to be involved in at least two distinct signalling pathways, classical and trans-signalling. The hypothesis is that classical signalling by IL-6 infers some beneficial effects (e.g. on gut barrier function), while excessive IL-6 trans-signalling may have detrimental effects. Olamkicept (FE 999301) has been shown in vitro to be a selective IL-6 trans-signalling inhibitor, and administered at lower doses (600 mg every 2nd week for 12 weeks) it has proven to induce clinical improvement for patients with ulcerative colitis. The aim of this trial is to investigate safety, tolerability, immunogenicity and pharmacokinetics of Olamkicept at higher doses (up to 2400 mg) to support the clinical development program. Our hypothesis is that treatment with higher doses of Olamkicept will result in greater clinical improvement for patients with inflammatory bowel diseases.


Eligibility Criteria:
Inclusion Criteria:

* Men ≥18 and ≤45 years of age at screening
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations, as assessed by the investigator (or designee) at screening and on Day -1

Exclusion Criteria:

* History of clinically significant medical conditions including, but not limited to, diseases of the renal, hepatic, respiratory, gastrointestinal, cardiovascular, neurological, musculoskeletal, psychiatric, immunological, haematological, oncological, endocrine, and metabolic systems and allergic diseases (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia

This phase II trial is studying how well giving imatinib mesylate together with decitabine works in treating patients with accelerated or blast phase chronic myelogenous leukemia. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving imatinib mesylate together with decitabine may kill more cancer cells

OBJECTIVES:

I. Determine the duration of response and response rate in patients with accelerated or blastic phase chronic myelogenous leukemia treated with imatinib mesylate and decitabine.

II. Determine the survival rate of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Determine the effects of this regimen on gene methylation in the leukemic cells of these patients.

OUTLINE: Patients are stratified according to prior exposure to imatinib mesylate (yes vs no).

Patients receive oral imatinib mesylate daily and decitabine IV over 1 hour daily, 5 days per week, for 2 consecutive weeks. Courses repeat every 4-6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 20-80 patients (10-40 per stratum) will be accrued for this study within 20 months.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed chronic myelogenous leukemia

  * Philadelphia chromosome positive by cytogenetics OR fluorescent in situ hybridization
  * Accelerated or non-lymphoid blastic phase
* Performance status - ECOG 0-2
* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST no greater than 2 times ULN
* Creatinine less than 2.0 mg/dL
* Normal cardiac function
* No New York Heart Association class III or IV heart disease
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior decitabine
* At least 2 weeks since other prior chemotherapy (unless there is evidence of rapidly progressive disease) and recovered
* Concurrent hydroxyurea allowed during the first 2 courses of study therapy in patients with rapidly progressing disease
* Prior imatinib mesylate allowed

  * Patients who received at least 4 weeks of prior imatinib mesylate must have failed therapy, as evidenced by resistance after 8 weeks or disease progression
* No concurrent grapefruit or grapefruit juice
Visceral Adiposity and CVD Risk in Women

To investigate the influence of total body fat and visceral fat on risk factors of diabetes and cardiovascular disease (CVD) in black and white women.

BACKGROUND:

Obesity is associated with increased morbidity and mortality. Concern about obesity has increased as the prevalence and severity have increased and the age of onset has decreased. It has also become clear that the location of fat may play an important role in determining the risk associated with obesity. Intra-abdominal fat has been shown to have particularly adverse consequences related to cardiovascular risk factors. Of interest is the fact that a number of studies have shown that the impact of overall adiposity differs by race. For each unit increase in adiposity, blacks appear to have less of an increase in blood pressure and triglycerides and less of a decrease in HDL cholesterol compared to whites. This racial difference in the relationship of adiposity to cardiovascular risk status may be related to differences in the distribution of fat. It is hypothesized that for a given level and increase in total body fat (measured by DEXA) black women will have less intra-abdominal fat (measured by magnetic resonance imaging).

The cohort to be studied is a defined group of black and white women who were initially recruited into the study as children at age nine or 10 years as part of the National Heart, Lung and Blood Institute National Growth and Health Study. The cohort has been maintained and studied continuously over the past 11 to 12 years with about 75 percent of the original cohort remaining.

DESIGN NARRATIVE:

Subjects will be studied at age 23 and again at age 25 years. At each examination, subjects will have measurement of total fat (DEXA), intra-abdominal fat (MRI), fasting lipids and lipoproteins, insulin and glucose, blood pressure, and left ventricular mass (by echocardiography). In addition, the timing of pubertal maturation and dietary intake of fat and sucrose will be evaluated as potential determinants of intra-abdominal fat using data previously collected from age nine years to age 22 years. Study of this cohort provides a unique opportunity to evaluate whether differences in deposition of intraabdominal fat are related to racial differences in the relationship between adiposity and cardiovascular risk factors. It will also allow evaluation of childhood and adolescent determinants of adult intra-abdominal adiposity. The results of this investigation may provide insight into the prevention of intra-abdominal fat accumulation and ultimate lowering of risk for cardiovascular disease.

Eligibility Criteria:
No eligibility criteria
Clinical Characteristics, Management and Outcomes of Chinese Patients With Acute Aortic Dissection

Data reported by the international registry of acute aortic dissection (IRAD) in not sufficient to reflect clinical characteristics of acute aortic dissection in China. Moreover, clinical characteristics of Acute aortic dissection have not evaluated to data. The aim of this study is analyze changing trend of clinical characteristics of Chinese patients with acute aortic dissection.

Acute aortic dissection is the most common aortic emergency, with an annual incidence of 3-5 cases per 100 000 population. About 50% of these patients are dead within 48 hours, if untreated. To assess the clinical manifestation, diagnosis, management, and outcomes of patients with AAD, the International Registry of Acute Aortic Dissection (IRAD) was established in 1996, and has grown to include about 2000 patients from 26 large referral centers to date. All patients from IRAD are caucasians from developed countries wiht advanced medical care, however, the proportion of Asian is very low. Data reported by the IRAD in not sufficient to reflect clinical characteristics of Acute aortic dissection in China. Clinical characteristics of Chinese patients with acute aortic dissection have not evaluated to data. The aim of this study is to analyze clinical characteristics of Chinese patients with acute aortic dissection and clinical trend of acute aortic dissection.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute aortic dissection
* Type A dissection
* Type B dissection
* Retrograde type B dissection

Exclusion Criteria:

* Aortic aneurysm
* Myocardial infarction
* Cerebral accident
* Active infection
* Unwillingness to cooperation with study procedures or follow-up visits
Withdrawal of Colchicine in Behçet Syndrome

Behçet's syndrome is a multisystem variable vessel vasculitis. Clinical features include mucocutaneous manifestions such as oral ulcers, genital ulcers, papulopustular lesions and nodular lesions, musculoskeletal manifestations, uveitis, venous thrombosis, arterial aneurysms and thrombosis, central nervous system involvement and gastrointestinal involvement. Management of Behçet's syndrome depends on the type of organ involvement, disease severity, and prognostic factors. The main objective in patients with major organ involvement is to rapidly suppress the inflammation and prevent relapses in order to prevent organ damage. On the other hand, mucocutaneous and musculoskeletal manifestations do not cause damage and in patients with only mucocutaneous and joint involvement, the aim is to improve the quality of life.

Colchicine is usually the first-line systemic treatment in patients with only mucocutaneous and joint involvement. Conflicting results were reported on the efficacy of colchicine on different mucocutaneous manifestations in randomized placebo-controlled trials. The relapsing and remitting nature of these manifestations in Behçet's syndrome may cause challenges in disease assessment during clinical trials. Another approach to evaluate the effectiveness of a medication is to evaluate whether the lesions recur or increase after discontinuation of the drug. The aim of this study is to assess mucocutaneous disease activity among Behçet's syndrome patients after discontinuation of colchicine treatment and compare it to patients who continue to use colchicine.


Eligibility Criteria:
Inclusion Criteria:

Fulfilling International Study Group criteria. Being between the ages of 18 and 65 years. Having mucocutaneous involvement. Using colchicine at a stable dose (1-2 mg/day) for at least 3 months. Showing no adverse events related to colchicine use. Providing informed consent to participate in the study. -

Exclusion Criteria:

Patients with active uveitis. Patients with active venous involvement. Patients with active arterial involvement. Patients with active nervous system involvement. Patients with active gastrointestinal involvement.

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Clinical Outcome of Extended-depth-of-focus Intraocualr Lens (SAV) Implantation

Clinical outcome of extended-depth-of-focus intraocular lens (SAV) implantation

In this study, we are trying to evaluate the clinical outcome of extended-depth-of-focus intraocular lens (SAV).

Eligibility Criteria:
Inclusion Criteria:

1. Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
2. Age-related cataract
3. A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
4. A patient want presbyopia correction at the same time as cataract surgery
5. A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
6. Written informed consent to surgery and participation in the study

Exclusion Criteria:

1. Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
2. Pregnant woman and lactating woman
3. A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
4. A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
5. If expectations for presbyopia correction are too high
6. Those who are not able to read and understand the informed consent (illiterate or foreigners)
Assessing the DSR Ankle

This research is being done to conduct a preliminary investigation into a new prosthetic microprocessor controlled (MPC) ankle, called the Damping, Stiffness, and Repositioning (DSR) ankle. The DSR ankle is a new design to support a person while they walk on both even and uneven ground, as well as with bending the ankle for safe foot clearance while a person takes a step. In particular, in this study we are interested in seeing how this type of new device may benefit people who are rated as a K2-level ambulator.

Synchro Motion, LLC developed a novel MPC ankle. Because of its unique actuation scheme, the prosthesis can behave as: (1) a lockable conformal damper, (2) a variable set-point spring, and (3) an actively repositionable joint.

The investigators therefore refer to the device as the damping, stiffness, and repositioning (DSR) ankle. The DSR ankle is small, lightweight, quiet, and runs for multiple days on a single charge. No other commercially available prosthesis combines this set of features. It will be shown in preliminary work that the features of the DSR ankle can increase toe clearance in swing, reduce the time-to-foot-flat after heel strike, and improve weight bearing symmetry when standing on slopes for K3 Individuals with Lower Limb Amputation (ILLAs). These biomechanical functions have all been linked to improved safety and stability, which leads the investigators to hypothesize that the DSR ankle may provide benefits to K2 ILLAs as well.

The main purpose of this research is to determine the ways in which the DSR ankle may be adapted to provide benefits specifically to ILLAs who use their prosthesis at the K2 level. For purposes of the Phase I work, the development and assessment will be performed exclusively with K2 ILLAs in order to provide an opportunity to implement any necessary refinements to the DSR ankle to ensure optimal K2 performance. The remainder of the research is to quantify the effectiveness of the DSR ankle as compared to a predicate non-MPC ankle in improving performance for K2 ILLAs.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged 18-89 years
2. Patients who have a unilateral transtibial amputation who are able to use a prosthesis and who currently use a passive, non-MPC prosthesis
3. K2 level ambulators

Exclusion Criteria:

1. Pregnant women
2. Children (\<18 years old)
3. Prisoners or institutionalized individuals
4. Individuals who have the inability to give informed consent
5. Participants unable to walk for 2 minutes without an assistive device
6. Participants with complicating health conditions that interfere with the study
7. Inability to read and understand the English language. As this is a pilot study with a small sample size, it is prohibitive to translate Study documents to other languages as recruitment will be from a sample of convenience.
Formulation Comparison in Normal Volunteers

This is a double-masked, single-center, crossover study in which normal volunteers will be randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8 days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment for 8 days.

Not desired.

Eligibility Criteria:
Inclusion Criteria:

* Normal volunteers

Exclusion Criteria:

* Active ophthalmic or systemic disease
Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

This study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can produce subject discomfort with medical and economic consequences. This study was designed to evaluate the treatment efficacy and safety of palonosetron for the subjects who undergo gynecologic or simple laparoscopic surgery. As the previous studies of palonosetron evaluated only the prevention of postoperative nausea and vomiting (PONV), there was no evidence-based guideline of palonosetron for treatment of PONV. The aim of the present study is to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* 19 years and older, younger than 70 years old
* American society of Anesthesiologists physical status classification I to III
* those who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia
* surgery for which anesthesia is expected to last at least 30 minutes
* if a subject has or may develop prolongation of cardiac conduction intervals, particularly corrected QT interval, he/she may be enrolled at the discretion of the investigator.

Exclusion Criteria:

* known hypersensitivity/ contraindication to 5-hydroxytryptamine antagonists or study drug excipient
* inability to understand or cooperate with the study procedures as determined by the investigator
* women who are pregnant, nursing or planning to become pregnant, are not using effective birth control, or that have had a positive serum pregnancy test within 7 days prior to surgery day 1.
* has received any investigational drug within 30 days before study entry
* having taken any drug with potential antiemetic efficacy within 24 hour prior to anesthetic procedures.
* any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia
* known or suspected current history of alcohol abuse or drug abuse.
* any condition, which in the opinion of the investigator would make the subject ineligible for participation in the study