cyrilzakka/clinical-trials huggingface dataset:
Zenith® AAA Endovascular Graft Clinical Study

The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm.
2. Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm.
3. Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year.

Exclusion Criteria:

1. Patients less than 18 years of age.
2. Patient with a life expectancy less than 2 years.
3. Patients who are pregnant.
4. Patients unwilling to comply with the follow-up schedule.
5. Patient inability or refusal to give informed consent.
The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents

The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents

Inclusion Criteria:

1. Male and female patients aged 18 to 80 years who have a Ch 4.7-6.0 polyurethane ureteral stent

Exclusion Criteria:

1. Active phase of urinary tract infection
2. Insufficient level of social adaptation
3. The patient does not have a smartphone with Internet access

All patients will be randomized into 2 groups:

* group A - patients who used the Stone MD mobile application
* group B - patients who did not use the mobile application Patients are to be assigned a randomization number that will match their treatment. Block randomization using 10 blocks is to be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.

"Stent Radar" - part of the "Stone MD" mobile application. This tool is designed for the patient to remove the ureteral stent using a mobile application within the time period prescribed by the doctor. After the operation, the patient independently enters the data related to the installation of the stent in the Stent Radar section of the Stone MD mobile application. This data includes: the name of the stent, the side of insertion, and the estimated date of removal. In a few days, a push notification appears in the application stating that it is necessary to consult a doctor for the timely removal of the stent. Thus, it is almost impossible to forget to remove the stent.

At discharge, we strongly recommend that all patients install the Stone MD mobile app on their smartphone. In the postoperative period, all patients will be monitored. In the event that 2 weeks after the expected date of removal, the patient does not get in touch, he will receive a call from the clinic, reminding him of the necessary visit (to remove the stent).

Primary assessed outcomes:

1. Number of patients who removed the stent on time in both groups
2. Number of patients who delayed stent removal in both groups (less than 14 days)
3. Number of patients who forgot to remove the stent in both groups (removed the stent more than 14 days from the expected date of removal)

Secondary assessed outcomes:

1. Assessment of Stone-free status after surgery by performing computed tomography of kidneys and urinary tract without intravenous contrasting 1 month after surgery

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients aged 18 to 80 years who have a Ch 4.7-6.0 polyurethane ureteral stent

Exclusion Criteria:

1. Active phase of urinary tract infection
2. Insufficient level of social adaptation
3. The patient does not have a smartphone with Internet access
Safety and Efficacy of AGN-210669 Ophthalmic Solution Compared With Bimatoprost Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

This study will evaluate the safety and efficacy of AGN-210669 ophthalmic solution compared with bimatoprost ophthalmic solution (Lumigan®) as monotherapy and adjunctive therapy in patients with primary open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma or ocular hypertension in each eye
* Requires bilateral treatment with an IOP-lowering medication
* Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

* Use of oral, intramuscular, intravenous or topical ophthalmic corticosteroids within 2 months
* Inability to fast for up to 10 hours
* Prior refractive laser surgery (eg, LASIK, radial keratectomy, photorefractive keratectomy)
* Intraocular surgery or IOP-lowering laser surgery (eg, laser trabeculoplasty) within 6 months
* Current or anticipated use of artificial tears or any ocular medications aside from study medications during study
* Anticipated wearing of contact lenses during study
Work and Health Disparities Among Rural Women

This is a study of the effects of fast paced assembly line work on women. We are studying problems women in poultry processing have with their muscles, tendons, and nerves as well as acute injuries they have in the workplace. We are also studying how their work affects the quality of their lives.


Eligibility Criteria:
Women employed in poultry processing less than 9 months
Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing Total Joint Replacement

This study is being conducted to investigate the potential benefits of using a special type of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin preparation in patients undergoing total hip replacement (THA) or total knee replacement (TKA). Integuseal is supposed to lock down the skin bacteria and reduce skin infection and other problems. This study will investigate whether Integuseal is effective in reducing persistent wound drainage when used in addition to standard surgical skin preparation for total hip arthroplasty (THA) or total knee replacement (TKA).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are able and willing to provide informed consent;
2. Male and non-pregnant, non-lactating, female subjects who are willing to practice effective means of contraception or postmenopausal/surgically sterilized female subjects, between the ages of 18-80 years old, of any ethnic origin.
3. Subjects deemed able to comply with study schedule visits, procedures and medications as specified by the protocol.
4. Subjects undergoing elective THA or TKA procedures.
5. Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.

Exclusion Criteria:

1. Subjects undergoing revision, hemiarthroplasty, or bilateral THA or TKA
2. Subjects undergoing non-elective THA or TKA procedures.
3. Pregnant or lactating females or females of childbearing potential not practicing an effective method of contraception.
4. Subjects with known allergies to iodine and/or chlorhexidine
Preventive Intervention to Promote Healthy Ageing

The aim of the project is the support of healthy ageing of older adults in acommunity. Efficient educational and psychosocial intervention will besuggested and verified to prevent anxiety, depression, and cognitivedisorders of selected older adults, to im-prove their self-esteem,meaningfulness of life, sense of coherence, quality of life, and attitudes toold age. Correlations among anxiety, depression, cognitive functions, andcertain psychosocial aspects will be analyzed.

The main objective of the project is to determine the efficiency ofeducational pro-grams and psychosocial interventions to maintain mentalhealth, to prevent and timely diagnose any depression, anxieties, andcognitive disorders in older adults living in a community. Furthermore, theaim is to ascertain the incidence of depression, anxiety, and cognitivedisorders in these older adults and its correlation to the assessment of lifemeaningfulness, self-respect, attitudes to old age and ageing, and the levelof social support. An intervention study will be carried out. A preventionprogram will be for-mulated based on the individual needs of older adults asidentified in the focus groups. Selected interventions will be performed in apresent form (face to face) as well as distance form (e-Health) and will runat least for 6 months. The assessment of anxiety, depression, cognitivefunctions, and other psychosocial aspects will be done before theinterventions start, when they finish, and 3 months after that. Based on-quantitative analysis, there will be evaluated the efficiency of the providedinterven-tion with respect to depression, anxiety, cognitive function, andpsychosocial aspects (attitudes to old age, self-esteem, the sense ofcoherence, quality of life, level of social support). Older adults in thecentrum for prevention and support healthy ageing in the community will beincluded in the research sample. Based on the findings, recommen-dations will be formulated regarding the selected interventions used in communi-tycare.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 60 years
* living at home in Moravian-Silesian region
* consent with partici-pation in the study
* no dementia diagnosis.

Exclusion Criteria:

* dementia diagnosis
Evaluating a Pharmacokinetic Drug Interaction Between HGP0918 and HGP0816

The investigators investigate the potential pharmacokinetic drug-drug interaction between HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and both together in a 3 period repeatedly


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
* Healthy male volunteers, aged 19 to 55 years.
* The result of Body Mass Index(BMI) is not less than 18.5 kg/m2 , no more than 27.0 kg/m2

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Someone has a declined liver function and Liver enzyme (AST, ALT or total bilirubin) level exceeds more than one and a half times normal upper range
* Somenone has a declined kidney function and his eGFR \< 60mL/min/1.73m2
Whole Body Vibration Therapy in Participants With MS Related Balance Deficits

The purpose of this investigation is to determine the effect of Whole Body Vibration Therapy (WBV) on balance in participants with multiple sclerosis (MS) related balance deficits as measured by the NeuroCom Balance Master, the Sapphire IIME EMG Device and the Kurtzke Expanded Disability Status Scale (EDSS) and the Berg Balance Score.


Eligibility Criteria:
Inclusion Criteria:

* Logan student, staff, or faculty or general public with a minimal of 2 year history of diagnosed Multiple Sclerosis (MS)

Exclusion Criteria:

* Visual or vestibular condition that would affect balance
* Non-Ms related systemic illness that would have an adverse effect on balance
* Local infection, acute inflammation, injury, tumors or other malignancy, recent wounds, diabetes
* Any unstable joints of the lower extremity, recent hip and knee joints or fitted hip or knee pins, bolts and/or plates
* Acute thrombosis
* Severe migraine, epilepsy
* Serious cardiovascular disease, wearing a pacemaker
* Any Spinal manipulation within 48 hours
* Acute disc herniation, discopathy or spondylolysis
* Prescription or herbal muscle stimulants, relaxants, etc. that could affect balance
* Any implanted device or prosthesis or intrauterine IUD type of device
* Pregnancy
Influence of Strength Training and Protein Supplementation on Fitness of Institutionalized Elderly

The aim of this randomized, observer-blind, controlled intervention study with parallel groups is to study the effect of strength training (2x/week for 6 months) with and without additional dietary supplementation (protein-enriched) on muscle strength, function and mass, oxidative stress parameters and the immune system in elderly institutionalized persons.

The participants (n = 120) are recruited from Viennese senior residencies (Kuratorium Wiener Pensionistenwohnheime). After a pre-participation screening participants will be distributed randomly but stratified by sex and age to one of the 3 intervention groups (cognitive training, strength training, strength training + supplement).

Study participants are eligible if they are male or female with an age over 65 years and if their cognitive status as well as their physical fitness level allows to participate at the strength training sessions. Exclusion criteria comprise chronic diseases which contraindicate the medical training therapy, serious cardiovascular disease, diabetic retinopathy and manifest osteoporosis, medication with anticoagulants or cortisone drugs and also regular strength training during the last six months.

Primary outcome measure is the change in isokinetic torque of knee extensors. Secondary outcome measures comprise anthropometric data, functional performance tests, immunological and oxidative stress parameters. The change in muscle signaling pathways will be assessed from muscle biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Adequate mental condition in order to follow the instructions and to perform the resistance exercise independently (Mini-Mental-State \>23)
* Ability to walk 10 meters independently (without orthopaedic devices)
* 4 or more points at the Short Physical Performance Battery

Exclusion Criteria:

* Chronic diseases, which contraindicate a medical training therapy
* Serious cardiovascular diseases (congestive chronic heart failure, severe or symptomatic aortic stenosis, unstable angina pectoris, untreated arterial hypertension, cardiac arrhythmias)
* Diabetic retinopathy
* Manifest osteoporosis
* Regular use of cortisone-containing drugs
* Regular strength training (\> 1x / week) in the last 6 months before inclusion
Impact of HIV-1 and Aging on Mucosal Vaccine Responses

The purpose of this study is to learn more about both HIV-1 infection and advancing age, and their association with increased risk of serious infection and impaired response to the Prevnar 13 vaccine.

After being informed about the study and potential risks, patients will be screened to determine eligibility for the study and consented. Patients who meet eligibility requirements will be immunized with PCV 20. HIV-infected adults will be tested prior to and after vaccination by blood, nasal filter paper, and stool samples to characterize mucosal and systemic antibody responses . HIV-uninfected control adults will be tested at vaccination and post vaccination to characterize mucosal and systemic antibody responses .

Eligibility Criteria:
Inclusion Criteria:

* Veterans only (accessibility to non-veterans pending)
* Age 21-45 or 55-75 Years Old
* Have not received pneumococcal vaccine Prevnar PCV-13
* Able to attend 2-3 study visits over 1 month

HIV+:

-Undetectable Viral load

HIV negative controls:

-no history or risks for HIV infection

Exclusion Criteria:

* Spleen removed
* Chronic Kidney disease (creatinine ≥ 2.0 mg/dL)
* Active liver disease
* Currently taking: Corticosteroids (prednisone, medrol, etc), Chemotherapy, Immunosuppressive medication (cyclosporine, methotrexate, azathioprine, infliximab, adalimumab, rituximab, etanercept, etc), or illicit drugs (methamphetamine, cocaine, crack, or heroin)
Exploration the Effect of Walking Program in Patients With Colorectal Cancer

The aims of this four-year study are to

1. explore the relationships between fatigue and muscle strength (i.e., upper limbs and lower legs)
2. comparison with the effects of 8-week, 12-week moderate intensity of walking program on muscle strength and fatigue.
3. develop a clinical guidelines of home-based walking program for patients with colorectal cancer receiving active treatment and survivors in Taiwan.
4. explore the relationships among the self-report fatigue intensity and metabolism.


Eligibility Criteria:
Inclusion Criteria:

* Patients with colorectal cancer in receiving active treatment or completed treatment within 5years.
* Patients in Different Stages.
* Aged above 18.

Exclusion Criteria:

* KPS\<60
Remote Magnetic Versus Manual Navigation-guided Ablation for Non-outflow Tract Premature Ventricular Contractions: a Prospective, Randomized, Controlled Trial

This prospective, randomized, controlled trial is designed to compare the safety and efficacy of remote magnetic navigation-guided ablation for ventricular premature complexes arising from non-outflow tracts with manual control navigation.


Eligibility Criteria:
Inclusion Criteria:

1. non-outflow tract PVCs
2. Holter\>10,000/24h or PVCs load\>10%
3. the first ablation procedure
4. failure of at least one AAD to treat PVCs before ablation

Exclusion Criteria:

1. PVC ablation history
2. HF with NYHA IV
3. 3 months prior to AMI or PCI
4. Cardiac thrombosi
5. Hyperthyroidism
6. Pregnancy
Assesment of Salivary Alpha-amylase Levels Before and After Ovulation

Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women.

Saliva is a readily available specimen, which can be collected by noninvasive procedures and contains many hormones, drugs and antibodies of interest in screening and diagnosis. With a salivary specimen, one can collect multiple specimens at the optimum times for diagnostic information. Saliva can be collected in remote sites by unskilled personnel and, is stable at ambient temperatures for several weeks. Because of diurnal and monthly variations, several steroid hormones need multiple samples collected early in the morning or late at night or at the same time every day for a month to give meaningful results. Such collections are often very expensive, inconvenient or impossible to do with blood.

Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PCOS (study group)
* Reproductive age regular menses women

Exclusion Criteria:

* pregnancy,
* breastfeeding,
* known liver disease,
* alcohol abuse,
* diabetes mellitus,
* smoking
* treatment with oral glucocorticoids
* treatment with hormonal contraceptives.
A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers

This is a Phase 1 study during which patients with advanced cancer will receive investigational study drug ARRY-382. Patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* A histologically or cytologically confirmed diagnosis of advanced or metastatic solid cancer refractory to standard treatment, for which no standard therapy is available or for which the patient refuses standard therapy.
* Measurable disease or evaluable, nonmeasurable disease.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2.
* Hemoglobin ≥ 9.0 g/dL, ANC \> 1500/uL and platelet count ≥ 100,000/uL.
* AST/serum glutamic oxaloacetic transaminase (SGOT) and ALT/serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 × the upper limit of normal (ULN).
* Bilirubin ≤ ULN.
* Serum creatinine ≤ 1.5 × ULN.
* Potassium, magnesium and calcium (corrected calcium when serum albumin levels are abnormal) within the normal range.
* Additional criteria exist.

Key Exclusion Criteria:

* 12-lead ECG demonstrating a mean QTcF \> 450 msec (triplicate assessment) at the Screening Visit or history/evidence of long QT syndrome.
* History of acute coronary syndromes, including unstable angina, coronary angioplasty, or stenting, within the past 24 weeks.
* Use of concomitant medications that prolong the QT/QTc interval, as assessed by the Investigator, within 14 days prior to first dose of study drug.
* Use of concomitant medication that is a strong CYP3A inhibitor or inducer within 14 days prior to first dose of study drug.
* Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
* Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must have been stable for at least 30 days).
* Active refractory nausea and vomiting, chronic gastrointestinal diseases (e.g., inflammatory bowel disease) or significant bowel resection that, in the judgment of the Investigator, would preclude adequate absorption (a previous Whipple procedure is allowed).
* Additional criteria exist.
Treatment With MSC in HIV-infected Patients With Controlled Viremia and Immunological Discordant Response

Phase I/IIClinical trial, proof of concept, double blind, and placebo-controlled, randomized 2:1 (MSCs: placebo), total sample size is 15 subjects

This is a phase I-II, randomised, placebo-controlled, clinical trial, currently ongoing in a single Spanish hospital (Hospital Virgen del Rocío, Seville), to evaluate the safety and feasibility of a 4-doses treatment regimen with MSCs (1 million cells/Kg MSCs, weeks 0-4-8-20) in HIV infected adults with swith discordant virological and immunological response to antiretroviral therapy. In the initial phase of the trial (n=5), patients were sequentially recruited, with a safety period of 15 days, receiving unblinded cell therapy. In the second phase of the trial, subjects are block randomised (1:1) to receive either MSCs (n=5), or placebo (n=5), as the control treatment. Immune response variables, adverse events, opportunistic infection signs are evaluated as determinants of safety and efficacy of MSCs. Study endpoints are measured along a follow-up period of 24 months, that includes 17 visits according to a decreasing frequency rate. Intention to treat, and per protocol, and safety analysis will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed HIV infection
* Age\> 18 years, both sexes
* In treatment with antiretroviral therapy (ART)
* Sustained HIV viral load \<50 copies / ml for ≥ 1 years prior to study entry
* CD4 + cell count \< 350/mL
* Immunological discordant response defined as: an increase \<75 or \<150 in CD4+ cell counts within one or two years of undetectable viraemia, respectively; or CD4 + cell count \<350/mcl after 3 years of ART and undetectable viraemia (\<50 copies/ml) ≥ 1 year
* Writen informed consent
* In women of child bearing potential or her partners:commitment to use contraceptive method of proved efficiency throughout the duration of the clinical trial

Exclusion Criteria:

* Pregnancy, breastfeeding, or refusal to the use of contraceptive methods
* Opportunistic infections in the last 12 months prior to study entry
* Active co-infection with hepatitis B virus/hepatitis C virus
* Child Pugh's scale stage C cirrhosis of the liver of any a aetiology
* Portal hypertension and / or hypersplenism of any aetiology
* Malignant neoplasia
* Treatment with steroids, immunomodulators, interferon, chemotherapy or any other medicinal product that could modify the number of CD4+ within the last 12 months prior to study entry
* Confirmed analytical 3 or 4 grade (AIDS Clinical Trials Group scale) abnormalities