cyrilzakka/clinical-trials huggingface dataset:
Central Apnea in Patients Receiving Ticagrelor

all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy

all patients with a left ventricular ejection fraction superior or equal to 50% less than 2 years after an acute coronary event and receiving ticagrelor will undergo a sleep polygraphy the main objective of the study will be to look for central sleep apnea

Eligibility Criteria:
Inclusion Criteria:

* patient receiving ticagrelor 10 days to 2 years after an acute coronary syndrome

Exclusion Criteria:

* left ventricular ejection fraction \< 50%
* patients refusal
Corneal Endothelial Cell Changes After Phacoemulsification in Patients With Type 2 Diabetes Mellitus

This study investigate the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

The investigators do the clinical prospective study including 30 patients with type 2 diabetes and 30 control patients without diabetes scheduled to undergo cataract surgery. The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.Then, the investigators compared the two sets of data. At last observing the change of the corneal endothelial cells in patients with type 2 diabetes after phacoemulsification with intraocular lens implantation.

Eligibility Criteria:
Inclusion Criteria:

the experimental group:

1. Clinical diagnosis of cataract
2. Type 2 diabetes mellitus
3. The recent blood glucose control was stable
4. The glycosylated hemoglobin \< 8%

The control group:

1. Clinical diagnosis of cataract
2. No history of type 2 diabetes

Exclusion Criteria:

1. Corneal lesions
2. Anterior inflammation
3. Ocular trauma or surgical history
4. Glaucoma
5. Corneal endothelial cell density \< 1500 / mm squared
Penile Prosthesis in Patients With Erectile Dysfunction

Erectile dysfunction (ED) is defined as the persistent inability to attain and or maintain an erection sufficient to permit satisfactory sexual performance

In the literature, well- designed studies evaluating safety and efficacy of inflatable penile prosthesis (IPP) is lacking. So, this series aimed at investigating this prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Patients complaining of ED with contraindication or failure of medical treatment

Exclusion Criteria:

* Patients lacking manual dexterity or mental abilities necessary to operate the pump
* General contraindications as uncorrectable bleeding tendency
Multidisciplinary Combined Exercise and Nutrition Intervention for Sarcopenia

This study aims to demonstrate the effect of combined exercise-nutrition intervention in old adults with sarcopenia. This study will be conducted with prospectively randomized controlled trial comparing outcome of combined exercise-nutrition intervention with conventional medical care. Handgrip strength, gait speed, knee extensor muscle power, physical performance, muscle mass using DEXA, quality of life, activities of daily living, sarcopenia screening questionnaire, nutritional assessment will be evaluated on baseline, 12-weeks and 24-weeks after intervention.

The definition of sarcopenia is age-related loss of skeletal muscle and physical functions. Sarcopenia is emerging health problem and increases medical expenditure as the population ages. Sarcopenia is closely related to chronic diseases and geriatric diseases. In particular, patients with metabolic syndrome showed a high prevalence of muscle loss and muscle weakness. It has been reported exercise in sarcopenia patients not only improved insulin sensitivity and physical performance but also helped the treatment of the diseases. Also, it is recently demonstrated that combined exercise-nutrition intervention improved muscle function in elderly patients. However, there is still not established standard protocol for the combined exercise-nutrition intervention. Therefore, the aim of this trial is to compare the effects of combined exercise-nutrition intervention in sarcopenia patients with multicenter, multidisciplinary, randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* patients older than 65 years and under 90 years
* patients who meet the criteria for the Asian Working Group for Sarcopenia (AWGS) 2019
* patients who had metabolic syndrome

Exclusion Criteria:

* patients with less than estimated glomerular filtration rate (eGFR) 30
* patients with musculoskeletal or chronic lung disease incapable of exercise
* patients with untreated or uncontrolled cardiovascular disease which may affect muscle mass or performing exercise
* patients less than 5 years after treatment of malignant tumor
* patients with liver cirrhosis, diabetes and other chronic disease
* patients who cannot perform combined exercise nutrition intervention for other reasons
Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with brentuximab vedotin in patients with hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Hodgkin's Lymphoma
* Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Known hepatitis B virus, hepatitis C virus or HIV infection
* Autologous hematologic stem cell transplant within 3 months of study entry. Patients who had prior Allogeneic hematologic stem cell transplant are excluded
Worksite Exercise Intervention Effects on Cardiovascular Disease Risk Factors and Physical Activity Levels Among Healthy Employees

Objective: To investigate the effects of a one-year worksite individual exercise intervention on lifestyle-related modifiable health risks, physical capacity and work performance.

Methods: Two hundred ninety-five employees volunteered to participate (n=191 women, n=104 men), aged 38 ± 8 years and body mass index (BMI), 24.71 ± 3.79. Measures of physical activity levels were assessed by the long self-administrated version of the International Physical Activity Questionnaire-Long Form (IPAQ-L), and all subjects performed a maximal cardiopulmonary treadmill graded exercise test. Blood samples and anthropometry measures were collected from participants at baseline survey, at 6 months and 1-year after. Components of the program included supervised moderate to high intensity cardiorespiratory exercise, resistance training, and flexibility.


Eligibility Criteria:
Inclusion Criteria:

Working in ASISA company, middle-age (20-60)

Exclusion Criteria:

No medical condition contraindicating exercise participation
Endomicroscopy in Ulcerative Colitis

This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be available before any trial-related procedures
* Male and female patients aged 18 years and older
* Clinically and histologically verified UC
* Duration or Colitis ulcerosa \>8 years (date of first diagnosis)
* Colitis Activity Index ≤ 8
* Activity index of Truelove and Witts: mild
* Ability of subject to understand character and individual consequences of clinical trial
* For women with childbearing potential, adequate contraception.

Exclusion Criteria:

* Known intraepithelial neoplasia or colorectal cancer
* Coagulopathy (Prothrombin time \<50% of control, Partial thromboplastin time \>50 s)
* Impaired renal function (Creatinine \>1.2 mg/dL)
* Pregnancy or breast feeding
* Inability to obtain informed consent
* Active GI Bleeding
* Known allergy to methylene blue or fluorescein
* Participation in other clinical trials within the last 4 weeks
Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment

The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.

The intent of this study is to evaluate the clinical performance of an experimental dental bonding agent (adhesive) for use with dental restorative composites with and without pretreatment of the tooth dentin and enamel using phosphoric acid etching.

Eligibility Criteria:
Inclusion Criteria:

* Patients in need of Class I and Class II restorations in premolars and molars.

Exclusion Criteria:

* Patients with fewer than 20 teeth
* Patients exhibiting poor oral hygiene or uncontrolled periodontal disease
* Pregnant women or lactating mothers
* Patients with known allergies to HEMA or resin-based materials
* Patients with medical conditions that would contraindicate dental treatment
* Patients with xerostomia
Walk With Me: a Mobile Application to Improve Walking in Persons With MS

During 10 weeks the subjects will use a mobile application (Walk with Me). The aim of this study is to investigate the usability of the mobile application, as well as investigating if the mobile application effects walking.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis according to the McDonald Criteria
* Able to walk independently or with unilateral support for 10 minutes

Exclusion Criteria:

* Exacerbation or relapse within last 3 months before study
* Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia, stroke, Parkinson).
Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome

This study investigates the use of glycomacropeptide (GMP) as a means to manipulate the gut microbiome, metabolome and protein profile of subjects with irritable bowel syndrome (IBS).

In vitro assays show that GMP strongly promotes the growth of beneficial bacteria including Bifidobacterium breve, B. bifidum, B. infantis and Lactococcus lactis. GMP also binds to pathogenic bacteria and prevents their adhesion to intestinal cells, which could prevent enteric infection. GMP also modulates the inflammatory response of key gut immune cells called macrophages. However, the extent to which daily consumption of GMP alters the gut microbiome, metabolome and protein profile of subjects with IBS remains unknown.

This study will investigate how daily GMP consumption can alter the gut microbiome, metabolome and protein profile of subjects with IBS.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* IBS diagnosis with Rome IV criteria
* People who have a primary care provider

Exclusion Criteria:

* Lactose or milk protein intolerance
* Any known other gastrointestinal disease or disorder beyond IBS, or major gastrointestinal surgery
* Habitual use of laxatives or antacids
* Pregnant or nursing.
* Use of pre or probiotics within one month prior to the study
* Use of antibiotics within one month prior to the study
A Long Term Safety Study With Atrasentan

The primary purpose of the study is to evaluate long-term safety and tolerability of atrasentan 10 mg in men with hormone refractory prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years, inclusive;
* Subject is currently active in an atrasentan clinical study OR has histologically or cytologically documented diagnosis of prostate adenocarcinoma and is considered hormone refractory;
* Karnofsky Performance Score greater than or equal to 60;
* Adequate hematologic function and liver function tests;
* No New York Heart Association (NYHA) class greater than or equal to 2.
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients

The aim of this research to examine the effectiveness of video-education on pain, anxiety, and knowledge levels on adult patients undergoing coronary artery bypass graft surgery.

A video based patient education will be used in this randomized controlled study. Patient education via video aims to reduce the patient's anxiety levels, control their pain, and improve their health outcomes by increasing knowledge levels. In addition, since this training is visual-based, it is aimed to provide effective learning by reducing the inequality due to sociodemographic and individual differences between participants. The video-education includes information about pre and post-surgical process and care.

Eligibility Criteria:
Inclusion Criteria:

* Being at least 18 years old
* Being hospitalized in Cardiovascular Surgery Clinic and Cardiovascular surgery intensive care unit
* Undergoing coronary artery bypass graft surgery for the first time, by sternotomy method
* Patients who agree to participate in the research and read and sign the "Informed Volunteer Consent Form for Scientific Research"

Exclusion Criteria:

* Patients with visual or hearing impariment
* Patients with psychiatric illness,
* Patients with known cognitive impairment (dementia, Alzheimer's).
Influence of Age on Trauma Femoral Fractures

This study aimed to determine the influence of ageing on the incidence and site of femoral fractures in trauma patients, by taking the sex, body weight, and trauma mechanisms into account.

This retrospective study reviewed data from adult trauma patients aged ≥ 20 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2016. According to the femoral fracture locations, 3859 adult patients with 4011 fracture sites were grouped into five subgroups: proximal type A (n = 1,359), proximal type B (n= 1,487), proximal type C (n = 59), femoral shaft (n = 640), and distal femur (n = 466) groups. A multivariate logistic regression analysis was applied to identify independent effects of the univariate predictive variables on the occurrence of fracture at a specific site. The propensity score accounts for the risk of a fracture at a specific femoral site was calculated and presented visually with age in a two-dimensional plot.

Eligibility Criteria:
Inclusion Criteria:

* Patients to be aged ≥20 years and hospitalized for the treatment of femoral fracture following injury

Exclusion Criteria:

* Patients with incomplete data were excluded
Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease

This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA) using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral Artery disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and above
* Subject with claudication or critical limb ischemia(Rutherford classification level 2\~5)
* Subject with total occlusion or stenosis ≥70%(de novo, restenosis)
* Vessel diameter 4\~6mm
* Success to guide wire pass
* Patients who don't have known hypersensitivity or allergy for dual-platelets
* Willing and able to provide informed written consent

Exclusion Criteria:

* Acute stage
* Acute thrombosis in target limb or target vessel
* Failure to guide wire pass
* Distal outflow
* Lesion with poor inflow
* Life expectancy ≤ 2 years
* Allergic to paclitaxel
* Pregnant or breast feeding woman or disagree with contraception or having children
AI to Support Mental Health Case Management Providers

The goal of this clinical trial is to assess the effectiveness of an artificial intelligence (AI) platform for case managers in a nonprofit health system specializing in mental health and substance use disorder. The main questions it aims to answer are:

1. Is the AI platform acceptable and feasible for case managers?
2. Does the AI platform improve providers' productivity and reported interventions? Participants will be approximately 30 case managers and their 250 adult clients receiving case management services. Researchers will compare the provider productivity and work satisfaction prior to the implementation of the AI platform to following its implementation.


Eligibility Criteria:
FOR PROVIDERS:

Participating providers must be Centerstone case managers.

FOR CLIENTS:

Inclusion Criteria:

1. Participants must be adults.
2. Participants must be receiving case management services from a Centerstone provider

Exclusion Criteria:

1. Participants currently involved in any other concurrent research study will be excluded to avoid potential confounding factors.
2. Participants with any medical conditions or medications that may significantly interfere with the study outcomes will be excluded.
Health Effects of Wood Smoke and Traffic-Related Air Pollution Exposures: a Necessary Comparison

Accumulating evidence demonstrates that breathing air pollutants leads to devastating increases in sickness and death worldwide over time. However, there is little data comparing the effects of different types of air pollution on health. In Canada, traffic-related air pollution and wood smoke (wildfires and wood burning for heating) are very common air pollutants. This study aims to safely complete a controlled human exposure study to test how these air pollution types acutely affect health.

Healthy adult participants (total 48; 24 of each biological sex assigned at birth) will breathe filtered air (control), wood smoke (WS), diesel exhaust (DE), and DE plus WS (DEWS) each for 2 hours, with 4 weeks between each exposure (washout). Before and after each exposure, participants will answer questions, perform breathing tests, and give blood samples. At 24 hours after each exposure, participants will undergo a bronchoscopy to collect samples from their lungs.

The study will look at what (if any) are the differences between breathing in fresh air (filtered air - FA) or polluted air containing either wood smoke (WS), diesel exhaust (DE) or diesel exhaust plus wood smoke (DEWS). The research team will use wood smoke generated from pine wood, since it is one of the most common types of wood found in Western Canadian forests where forest fires occur.

The investigators will evaluate multiple endpoints as detailed in the Outcome Measures section. For each applicable endpoint, the investigators will evaluate stratified analyses and effect modification by biological sex, participant age, gene score, and microbiomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-40
* Healthy, with no history of respiratory disease
* Lifetime non-smoker and non-vaper.

Exclusion Criteria:

* Pregnant, planning to become pregnant, or breastfeeding during the study period (confirmed through pregnancy tests at each visit if applicable)
* Frequent WS or DE exposures (e.g. home fireplace used for heating/cooking, or employment in transportation, mining, or as a firefighter).
Modalities of Renal Replacement Therapy in Pediatric Acute Kidney Injury

Limited prospective data is available to compare morbidity and mortality between renal replacement modalities in pediatric acute renal failure.

In the absence of clear standard of care, the choice of the extra renal replacement therapy modality is subject to clinical judgement, practical aspects, and costs.

This study will supply important data about usual modalities of pediatric acute extra renal replacement therapy and their impact on patient outcome and renal recovery. An obvious next step will be to conduct a randomized controlled trial comparing the different strategies.

In children, there are limited data on extra renal replacement therapy. Pediatric studies are often retrospective, or often limited to specific disease processes or specific extra renal therapy. The lack of large studies including different usual modalities in pediatrics limits any formal recommendation on use in relation to patient outcomes, including renal recovery and mortality. Some of the issues that need consideration are the choice of dialysis modality (including Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis), the indications for and timing of dialysis intervention, the dose of dialysis and their effects on outcomes from acute kidney injury in children.

This study will supply important data about pediatric acute extra renal replacement therapy, including the epidemiology of pediatric acute kidney injury leading to extra renal replacement therapy, the variety of the treatment modalities, and their effects on the course of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years, including the newborn ;
* Acute kidney injury as defined by pRIFLE classification requiring extra renal replacement therapy, whatever is the method.

Exclusion Criteria:

* Treatment by extra renal replacement therapy for terminal renal failure;
* History of renal transplantation;
* Extra renal replacement therapy for an inborn errors of metabolism without acute renal failure;
* Extra renal replacement therapy in the context of a drug intoxication without acute renal failure;
* Treatment by technique in MARS (Molecular Adsorbent Recirculating System);
* Modified ultrafiltration during surgery.
Safety and Effectiveness Study of an Experimental Topical Ointment (GS-9191) for the Treatment of Genital Warts

The purpose of this study is to assess the safety, tolerability and activity of GS-9191 ointment in the treatment of genital warts. GS-9191 ointment is intended for topical application directly to genital warts on the skin.


Eligibility Criteria:
Inclusion Criteria:

* Have 2 or more genital warts of prespecified sizes on external surfaces of the body.
* If HIV positive, have HIV RNA \< 400 copies/mL, CD4 count of ≥ 400 cells/mm3, and be taking a triple combination antiviral medication regimen

Exclusion Criteria:

* Prior genital wart treatment within 8 weeks
* Pregnancy or breast-feeding
* Presence of broken or non-intact skin near the wart site or other skin disease at the wart site (e.g., herpes genitalis)
* Treatment with systemic steroids, systemic immunomodulators, immunosuppressants, or chemotherapeutic agents within 3 months
* Current or prior diagnosis of Bowenoid papulosis, cancer, or pre-cancerous tissue in the genital area
A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden

This trial is conducted in Europe. The aim of this study is to investigate a retrospective database assessment of clinical effectiveness in type 2 diabetes patients treated with liraglutide from primary care centers in Sweden.


Eligibility Criteria:
Inclusion Criteria:

* Patients from EMR (electronic medical record) system in the primary care in Sweden
* Patients equal to or more than 18 years of age
* Starting treatment with liraglutide or sitagliptin from January 2010 to December 2013
* Minimum of 180 days of prior follow-up/history within the database before their index date

Exclusion Criteria:

* Patients with cancer, end stage liver disease, end stage renal failure (non-diabetes related)
* Female patients with gestational diabetes during pregnancy
* Patients with previous GLP-1 (glucagon-like peptide-1) or DPP-IV (dipeptidyl peptidase-4 ) inhibitor use, i.e. patients should be incretin naïve