cyrilzakka/clinical-trials huggingface dataset:
The Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Evogliptin in Hemodialysis Patients

A clinical study to investigate the pharmacokinetics/ pharmacodynamics and safety/tolerability of Evogliptin in hemodialysis patients


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who aged 20 to 80 at the time of screening
2. Subjects with 50.0kg≤Body Weight≤90.0kg and 18.0kg/m2≤BMI≤27.0kg/m2
3. Subjects who meet the following kidney functions

   * group1(hemodialysis patients): MDRD-eGFR ≤ 15 mL/min/1.73m2
   * group2(helthy control): MDRD-eGFR ≥ 90 mL/min/1.73m2

Exclusion Criteria:

1. Subjects who have a uncontrolled or unstable disease such as liver, nervous system, immune system, respiratory system, endocrine system or blood / tumor disease, cardiovascular disease, mental disorders (mood disorder, obsessive compulsive disorder, etc.) or history
2. Subjects who have a gastrointestinal disease (such as Crohn's disease, ulcers, acute or chronic pancreatitis, etc.) or history of gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of the test drug.
3. Subjects with a history of significant hypersensitivity reaction such as anaphylaxis or angioedema to DPP-IV inhibitors
4. Subjects who have AST (SGOT) and ALT (SGPT) greater than 1.5 times the upper limit of normal range, at the time of screening test including additional tests.
Effects of Video Game on Patients With Knee Osteoarthritis

To investigate the effects of video game play therapy in patients with knee osteoarthritis

A total of 80 patients with knee osteoarthritis were randomized into two groups, including video game group and exercise group.

Physical activity, quality of life, emotion, and balance were assessed at before treatment and follow-up assessments, including at after 2 week of treatment; after 4 weeks of treatment; and 1 and 3 months after treatment is terminated, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis with Kellgren/Lawrence grade II of greater ambulatory for more than 15 meters without support or orthosis usage

Exclusion Criteria:

* Knee operation history participants with pregnancy stroke history infection or fracture over lower limbs previously
Randomized Comparison of Endocardial Versus Epicardial - From the Coronary Sinus - Left Ventricular Pacing for Resynchronization in Heart Failure.

Biventricular pacing is a validated treatment for patients suffering from heart failure resistant to medical treatment. However, up to 30% of the patients are non responsive to this strategy using the coronary sinus approach to pace the Left Ventricle (LV).

It has been demonstrated that the magnitude of the improvement was highly dependant on the LV pacing site. The coronary sinus approach rarely offers more than 1 or 2 potential pacing sites. Resynchronisation using a transeptal approach to pace the left ventricle on the cardiology has been shown feasible on small series. We therefore would like to compare these two approached in a randomised prospective study to confirm the hypotheses that endocardial LV pacing by offering multiple choices for the pacing sites reduces the number of non responders and is associated with greater hemodynamic benefit when compared to the conventional coronary sinus approach.


Eligibility Criteria:
Inclusion Criteria:

* Adult (aged 18 or above)
* Cardiac insufficiency of whatever cause (ischemic or non-ischemic)
* Left ventricular ejection fraction \<35%
* NYHA Class III or IV with optimal medical treatment
* QRS duration \> 120 ms
* Sinus rhythm
* Patient must have signed informed consent
* Patient must be registered in the national health care system

Exclusion Criteria:

* Aged under 18
* Patient with a mitral or aortic prosthesis
* Patient with contraindication to anti-coagulants
* Pregnant women
* Participation in another study
* Patient with contraindication for left ventricle catheterization by retrograde aortic approach , as a severe aortic stenosis requiring surgery, or an ascending aorta aneurism
VIGIP-SEP2: Evaluation of the Impact of the Training of Patients by a Nurse on the Adverse Drug Reaction Reporting by RRMS Patient Via a Mobile Application: Randomized Real-life Study

The patient's reporting of adverse drug reactions (ADRs) is recognized as being of interest for post-marketing safety monitoring, but is still underdeveloped in France, with an average lower than the European average. A multidisciplinary team of the University Hospital of Caen, composed of neurologists and pharmacovigilants, has been carrying out since autumn 2017 a national study (VIGIP-SEP1) with 24 research centers in France (12 universitary hospitals, 6 general hospitals, and 6 private-practice neurologists) whose main objective was to evaluate the impact of multiple sclerosis (MS) patients' use of a mobile application (App) to report their ADRs. My eReport France® has been developed by the eVedrug company: ADR reports are sent by patients directly to the Regional Pharmacovigilance Centers, after analyze, clinical pharmacologist send it to the National Competent Authority. As part of VIGIP-SEP1, the accompaniment for the use of the App was carried out very simply by neurologists.

We designed a randomized controlled trial based on the assumption that a nurse training of the patient, after the initial prescription of an oral MS drug, with a telephone follow-up within 6 months, will increase by 3 times the number of patients who report ADRs compared to a simple information presented by the neurologist. The number of subjects required is 23 subjects per group.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years
* multiple sclerosis in initiation with a DMT
* patient informed and who gave informed consent

Exclusion Criteria:

* patient without mobile or tablet
Studies of Pancreatic Islet Mass by Positron Emission Tomography (PET)

This study investigates the hypothesis that differences in beta-cell mass in patients with diabetes and healthy individuals can be monitored by the positron emission tomography (PET) tracer \[11C\]5-hydroxytryptophane.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with type 1 diabetes
* Adult, healthy controls

Exclusion Criteria:

* Pregnancy
* Impaired renal function
The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer

The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.

There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
* Measurable lesion and/or non-measurable lesion defined by RECIST
* ECOG performance status ≦ 1
* Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
* Creatine ≦ upper normal limit (UNL)
* Total bilirubin ≦ 1.5 X UNL
* AST, ALT and ALP ≦ 2.5 x UNL
* Subjects must be able to take orally
* No prior chemotherapy
* Life expectancy estimated than 3 months
* Written informed consent

Exclusion Criteria:

* Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
* Known brain metastases
* History of hypersensitivity to fluoropyrimidines, oxaliplatin
* Active double cancer
* Treatment with any investigational product during the last 4 weeks prior to study entry
* Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0
* Any previous chemotherapy or radiotherapy for AGC
Alcohol Screening and Preoperative Intervention Research Study - 2

This sequential, multiple assignment, randomized trial will test treatments designed to reduce alcohol use before and after surgery to promote surgical health and long-term wellness.


Eligibility Criteria:
Inclusion Criteria:

1. Completed consent form, baseline survey, and enrollment phone call
2. Willingness to comply with all study procedures and availability for the duration of the study
3. Scheduled for select major elective surgery (non-cancer) in the next 5-12 weeks
4. Score ≥ 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications
5. Access to a smart device or computer access with internet or wi-fi connection throughout the study period

Exclusion Criteria:

1. Exclude participants enrolled in another research study focused on alcohol use
2. History of severe alcohol withdrawal
3. Unable to speak, understand, or read English
A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329

This study will characterize the effect of PF-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood samples will be collected to measure the amount of active metabolite of PF-04217329 in the plasma following dosing.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes
* Intraocular Pressure (IOP) of at least 22 mmHg and not more than 30 mmHg in either eye at 8 AM after discontinuing previous glaucoma treatment
* Visual acuity correctable to 20/100 or better in each eye.

Exclusion Criteria:

* Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
* Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye.
* Advanced glaucoma or a history of severe central visual field loss in either eye.
* History of ocular surgery or trauma in either eye within 6 months of the screening visit.
* History of ocular infection, ocular inflammation, or laser surgery in either eye within 3 months of the screening visit.
The Effect of a Combination of Orange- and Pomegranate Actives on Physical Fitness in Elderly People

The primary objective of this study is to determine the effect of daily supplementation of a combined orange- and pomegranate extract for a period of 4 weeks on physical fitness compared to placebo.

In this crossover study, participants will daily receive either a placebo or Actiful®, a supplement containing 500 mg orange extract and 200 mg pomegranate actives, for 4 weeks followed by a wash-out period of 4 to 8 weeks. Subsequently, the second intervention period of 4 weeks (active product or placebo) will take place. The product and placebo will be supplied in capsules that participants can ingest with a glas of water (daily, prior to breakfast).

Dietary habits and physical activity are two important components of a healthy lifestyle. Targeted nutritional interventions may improve health and stimulate physical activity. Both orange extracts and pomegranate concentrate have been shown to exert beneficial effects on health and exercise performance. However, the effects of a combination of the two extracts on exercise and physical activity have not been investigated yet. It is expected that this combination may be an effective dietary way to improve exercise performance, physical activity in the free-living state, and quality of life in a middle aged population.

Eligibility Criteria:
Inclusion Criteria:

* 60 - 75 years old
* non smoking
* BMI 18 -28 kg/m²

Exclusion Criteria:

* Allergy to test product/placebo or citrus fruits
* BMI lower than 18 or higher than 28
* Recent muscle injury in less than one month before the start of the study
* Inability to perform the fitness tests
* Medical conditions that might influence outcome measure or participant safety during testing, including but not limited to: severe cardiovascular disease, cancer, Parkinson's disease. To be decided by PI.
* High blood pressure (systolic ≥ 140 mmHg, diastolic ≥ 90 mmHg)
* Use of medication that may interfere with the study results, use of beta-blockers
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
* Abuse of products; alcohol (\> 20 alcoholic units per week) and drugs
Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

The goal of this study is to assess the role of battlefield acupuncture in the reduction of pain scores status post adult tonsillectomy. Secondary goals of this study include reduction in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an increased risk of worsening pain or improved response with acupuncture.


Eligibility Criteria:
Inclusion Criteria:

* Any adult patient who meets criteria and is scheduled for tonsillectomy

Exclusion Criteria:

* Any patient with prior use of acupuncture
* Individuals under age 18
* Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy,
* Patients with a known personal or family history of a bleeding disorder will be excluded.
* Patients with a history of kidney or liver problems will also be excluded.
* Patients found to be pregnant will be excluded from participation.
* Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.
Low Salicylate Diet in Aspirin Exacerbated Respiratory Disease

The purpose of this study is to determine whether a low salicylate diet will improve the quality of life of patients with Aspirin Exacerbated Respiratory Disease (AERD).

Aspirin-exacerbated respiratory disease (AERD) is clinically diagnosed in patients who suffer from allergy to aspirin, asthma, nasal polyps, and chronic sinusitis. Patients with AERD are often resistant to medical management of nasal polyps, and require multiple endoscopic sinus surgeries to manage recurrences of nasal polyps. Control of AERD can be obtained through aspirin desensitization, which consists of taking aspirin every day. However, there are substantial risks and adverse side effects to taking moderate amounts of aspirin daily. Furthermore, patients experience progressively worsening nasal and respiratory disease even with complete avoidance of aspirin and other NSAIDs.

The active and major component in aspirin/NSAIDs is salicylate, which is also found naturally in some foods. Diet modification is a cost-effective intervention that has the potential to provide long-term remission of AERD. Our study will evaluate whether a low salicylate diet, which is a more cost effective and benign intervention with minimal risks, will improve nasal, sinus or respiratory symptoms, such as congestion, sinusitis, smell, or asthma.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of AERD

Exclusion Criteria:

* Recent use of Prednisone or other systemic steroid (greater than three (3) doses in past three (3) months). This does not include the use of nasal steroids.
* Endoscopic sinus surgery / polypectomy within the past six (6) months
* Other significant systemic disease or immunocompromised state
Increasing HPV Vaccination in Pediatric, Adolescent, and Young Adult (PAYA) Cancer Survivors

The primary objectives of this study are to increase HPV vaccination initiation and 3-dose completion among pediatric, adolescent, and young adult (PAYA) cancer survivors

PAYA cancer survivors are 2.8 times more likely to develop a secondary human papillomavirus (HPV)-associated cancer than the general population. Unfortunately, HPV vaccination coverage among PAYA cancer survivors is even lower than that in the general population. Provision of adequate vaccine information and instructions for timing of vaccination post-treatment is associated with an increased intention to vaccinate. Nonetheless, research show a minority of cancer care teams specifically discuss HPV vaccination with PAYA cancer survivors and their caregivers. The purpose of this study is to test the efficacy of an oncologist- and clinic-level intervention and the additional effect of a patient-level app-based intervention to improve initiation and 3-dose completion of the HPV vaccine series.

Eligibility Criteria:
Inclusion Criteria:

* Current patient in the University of Minnesota CCSP clinic or the Children's Minnesota Long-Term Follow-up (LTFU) Program clinic.
* Patients seen in the CCSP clinic who do not have a history of cancer but who have received immunosuppressive therapy or HSCT for treatment of a hematologic disorder.
* Survivor of childhood cancer (defined as diagnosed with cancer at age 25 years or younger) who is currently 18-26 years of age OR a caregiver of a survivor of childhood cancer who is currently 9-17 years of age.
* 6+ months post-treatment; current treatment for graft-versus-host disease allowed
* No previous HPV vaccination or incomplete HPV vaccination (defined as \<3 doses post-cancer therapy). Individuals who are unsure of their HPV vaccination status who are unable to find vaccination records per the procedures detailed in Section 5.2, EHR support will be eligible, in concordance with real-world clinical practice regarding HPV vaccination.

Exclusion Criteria:

* Previous completion of the HPV vaccination series. Those who are eligible for re-vaccination per the CDC guidelines will be encouraged by their oncologist to re-vaccinate, but will not be included in the QI study or RCT.
* Unable to read/write in English per self-report (only applies to participants in the RCT \[Aim 2\]).
* Pregnant at the time of enrollment or plans to become pregnant in the next year. Pregnancy test at the time of enrollment is not required if pregnancy not clinically suspected in concordance with clinical guidelines for HPV vaccine administration.
* Currently receiving treatment for cancer or hematologic disorder or plan for treatment within 12 months of enrollment; treatment for graft-versus-host disease allowed.
* Other contraindications to the HPV vaccine (e.g. history of immediate hypersensitivity reaction to any vaccine component, including yeast).
Cochlear Implant Speech in Noise Processing

The study will help us in understanding the neural mechanisms by which listeners with a cochlear implant detect speech in noisy environments.

Despite the success of a cochlear implant (CI) for providing or improving hearing ability for people with severe hearing loss, everyday conversations in background noise are still the main clinical complaint. The goal of this study is to understand the neural mechanisms by which listeners with a CI detect speech in noisy environments, and to understand how these mechanisms differ across a variety of CI listeners, in order to determine what variables are most relevant for predicting successful outcome. Therefore the purpose of PET neuroimaging in this study is to find the brain regions that relate to speech in noise effort using PET during auditory stimulation on a single session across a variety of CI users with different device configurations. An age-matched typical hearing control group provides a baseline for comparison. PET neuroimaging will be performed using a radioactive form of water, O-15 (an investigational agent), that will be injected into the body to examine brain blood flow using a PET/CT scanner.

Eligibility Criteria:
Cochlear Implant subjects (enrollment is planned at N=120) - Inclusion criteria:

1. Between 18 and 99 years of age.
2. Have a cochlear implant activated for more than one year.
3. Eligible for research under the Iowa Cochlear Implant Project VIII.
4. Ability to understand and willingness to sign a written informed consent document.
5. Severe hearing loss after age 16.

Normal Hearing subjects (enrollment is planned at N=30) - Inclusion criteria:

1. Between 18 and 99 years of age.
2. Have age typical hearing.
3. Eligible for research under the Iowa Cochlear Implant Project VIII.
4. Ability to understand and willingness to sign a written informed consent document.

Exclusion criteria (all groups):

1. Medical history includes seizure disorder, head injury, neurologic, metabolic, cardiovascular disease, or previous cerebrovascular event (unless approved by PI).
2. Female self-reporting pregnancy. A urine pregnancy test will be performed prior to injection of the radiopharmaceutical.
3. Currently taking medications which may affect cerebral blood flow (e.g., papaverine, ginkgo biloba, acetazolamide).
4. Uncontrolled intercurrent illness that would limit compliance with study requirements per investigator.
Pilot Study of Glycemic Control in Diabetic Hemodialyzed Patients

The purpose of the study is to evaluate the effect of the basal-bolus detemir-aspart insulin regimen coupled with continuous glucose monitoring (CGM) on glycemic control in hemodialyzed patients with diabetes

We conducted a pilot prospective multicenter study in five French centers (Strasbourg University Hospital, Strasbourg Sainte Anne Hospital, Colmar, Mulhouse, Valenciennes) designed to evaluate the feasibility and effects of a 3 month treatment regimen with rapid-acting insulin and basal long-acting insulin analogues (i.e., aspart and detemir, respectively) along with CGM on glucose level control in diabetic hemodialyzed patients.

All patients who were admitted to the nephrology departments and matched the inclusion criteria between January 1st, 2010, and June 30th, 2012, were consecutively included in the study. CGM was used to analyze blood glucose excursions at baseline and 1 and 3 months of treatment. It was started during the first dialysis session and then continued for the next two days at home under ambulatory conditions. The CGM was continued during the next dialysis session. Therefore, in total, CGM (Navigator®; Abbott, Rungis, France) was performed for 54 hours, including two consecutive hemodialysis sessions and at 0, 1, and 3 months of treatment. The probe for the system was subcutaneously inserted at the beginning of the first dialysis session to analyze interstitial glucose, and it was removed at the end of the second dialysis session. Due to the time required for CGM calibration, plasma glucose levels were only partially recorded during the first dialysis session.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 83 years
* diagnosis of type 1 or type 2 diabetes
* treatment with insulin injections or oral hypoglycemic agents
* HbA1c ≥ 7% (i.e., 53 mmol/mol)
* on hemodialysis for more than three months

Exclusion Criteria:

* unstable anemia or blood transfusions within the two months prior to the beginning of the study
* a life expectancy of less than 1 year
* chronic inflammatory disease
* evolutive cancer requiring steroid treatment, chemotherapy, radiotherapy, or programmed surgery
* noncompliant patients