cyrilzakka/clinical-trials huggingface dataset:
Anal Incontinence and Its Impact on Quality of Life and Physical Activity Among Hungarian Women and the Hungarian Language Validation of the International Consultation on Incontinence Modular Questionnaire-Bowels (ICIQ-B)

The aim of the study is to assess the prevalence of anal incontinence among Hungarian women who have given birth at least once before, and to examine the impact of anal incontinence on the quality of life and physical activity of these women. A further aim of our study is to adapt the Hungarian version of the International Consultation on Incontinence Modular Questionnaire - Bowels (ICIQ-B) and to assess its validity and reliability.


Eligibility Criteria:
Inclusion Criteria:

* Have given birth at least once before
* Native Hungarian language

Exclusion Criteria:

* Menopause
* Irritable Bowel Syndrome (IBS)
* Chron's disease
* Ulcerative colitis
* Developmental abnormalities at the level of the pelvic organs
* Uninvestigated pelvic pain
* Malignant pelvic tumor
* Radiotherapy involving the pelvis
* Neurological diseases with muscle weakness
* Parkinson's disease
* Intellectual disability
Descemet Membrane Endothelial Keratoplasty (DMEK)

To evaluate isolated Descemet membrane transplantation as a refinement of previous advanced techniques for corneal transplantation, like Descemet Stripping Endothelial Keratoplasty (DSEK)

See above.

Eligibility Criteria:
Inclusion Criteria:

* Corneal endothelial disorders

Exclusion Criteria:

* N/A
Preventing Weight Gain in African American Reproductive-Aged Women

The purpose of this research study is to evaluate the effect of a Facebook-delivered weight-gain prevention program versus a Facebook-delivered program with general women's health information.

Weight gain is an important health concern, and disparities in the prevalence of obesity between African American and White women increase throughout the reproductive period. This study is a randomized, controlled trial testing the feasibility and acceptability of a peer-coach-administered, Facebook-delivered intervention to prevent weight gain in overweight and obese African American women. Study visits lasting approximately 1 hour will occur at baseline, post-intervention, and 1-month follow-up, to assess effectiveness and acceptability. The core intervention will occur over a 4-week period. Educational content in both the weight-gain prevention program and women's health program will be delivered via Facebook, with new content posted each weekday related to that week's topics. The peer coaches may contact participants via private messaging, when needed, to provide support and encourage engagement. If successful, this intervention could be easily disseminated to populations in under-served and community settings.

Eligibility Criteria:
Inclusion Criteria:

* African American
* Has Facebook account and uses it, on average, at least once a day
* Body Mass Index (BMI) of 25-45
* Has access to the internet
* Able to consent in English

Exclusion Criteria:

* Currently pregnant or breastfeeding, recently postpartum (within 6 weeks)
* Diagnosis of Diabetes Mellitus
* History of contraindicated medical conditions or conditions that can affect weight
* Current use of certain medications
Personalized Approach for Promoting Physical Activity in Mayo Clinic Physicians

The purpose of the study is to determine if providing physicians with a walking workstation, exercise counseling, and accelerometer feedback about activity will increase physician activity.

20 physicians will be given an activity monitoring accelerometer (GRUVE from MUVE, inc.) for 2 weeks prior to starting the study (without feedback) and will continue to have their activity monitored for the duration of the study. The accelerometer (monitors movement and accurately estimates physical activity energy expenditure). The physicians will be randomized to 12 weeks with accelerometer monitoring but no feedback or counseling (control) or to 12 weeks of accelerometer monitoring (experimental) with feedback about activity levels and 20 minute weekly counseling sessions on how to increase activity (including walking while working). In the 12 week period where physicians receive feedback and counseling, they will also be provided a walking workstation. The walking workstation (assembled by the investigators) has a computer keyboard, computer monitor and telephone attached to an exercise treadmill. This allows the user to walk at 1 mile per hour while dictating, typing, responding to e-mail, etc. The treadmill can be placed in an examining room if the physician wishes to use it while dictating notes or it can be placed in a separate office.

Those physicians assigned to monitoring only for the first 12 weeks will then receive monitoring plus feedback, counseling, and walking workstation use for the next 12 weeks. Those physicians assigned to feedback, counseling, and walking workstation use for the first 12 weeks will continue to receive accelerometer feedback but will no longer receive counseling or use a walking workstation for the subsequent 12 weeks.

Ten physicians will complete the above for the first 26 weeks of the study and 10 physicians will complete the above for the last 26 weeks of the study.

The time line of the study is as follows:

12 Wks Experimental → 12 Wks Control 10 MDs (Wk 1-26) → 2 wks Monitor 12 Wks control → 12 Wks Experimental

12 Wks Experimental → 12 Wks Control 10 MDs (Wk 27-52) → 2 wks Monitor 12 Wks control → 12 Wks Experimental

In summary, physicians use an accelerometer without feedback while in the control group. In the experimental group physicians receive three interventions: accelerometer with feedback, exercise counseling, and the use of a walking workstation (treadmill desk).

Eligibility Criteria:
Inclusion Criteria:

* Physicians working in the Department of Medicine at Mayo Clinic Rochester
* Age 25 to 70 years
* BMI \> 25
* Sedentary (exercise for 30 minutes less than 3 times weekly)

Exclusion Criteria:

* Metastatic cancer
* Unable to complete a Bruce protocol exercise stress test
* Planning on retiring in the next 6 months
* Planning on more than 3 weeks of vacation during the 6 month study
* Women of child-bearing age who are pregnant or planning on becoming pregnant.
The Role of Breast Milk Neutrophils From Mothers With Metabolic Diseases After Nutritional Intervention. Impact on Infant Development and Response to Pulmonary Infections

This project aims at identifying variations in breast milk neutrophils among lactating mothers with gestational diabetes or obesity (objective 1), and to describe how a dietary intervention with Omega-3 fatty acids affects these changes (objective 2). The occurrence of respiratory infections on the progeny will be analysed, as well as its development and the impact on gut microbiota and epigenetic changes (objective 3). The involvement of breast milk on the neonate's microbiota (sub-objective 1) and epigenetic variations (sub-objective 2) will be depicted. In addition, the direct engagement of milk neutrophils in the ability of the progeny to react against lung infections will be studied (sub-objective 3).

To attain these mother milk and blood samples will be obtained from three groups of lactating mothers: control, obesity or gestational diabetes, upon a dietary intervention with Omega-3 fatty acids. Neutrophil populations of maternal blood and milk samples will be studied by flow cytometry and in vitro assays. The microbiome and miRNA content of infant's saliva and tool samples will be characterized by 16s rRNA gene sequencing and PCR. The occurrence of respiratory infections and the development the infants participating in the study will be tracked during the first 2 years of life by telephone surveys.

To study the impact of the presented maternal variables on the progeny upon a respiratory inflammation on a systemic level, mouse models will be employed. The offspring of lactating dams with gestational diabetes or obesity will be subjected to an artificial acute lung infection. The progression of the lung disease will be studied by histology and the neutrophil profile in the organs of the litter by flow cytometry. The response to acute lung injury after fecal transplantation with infant's microbiota intro germ-free mice as well as of wild type pups breastfeed by neutropenic dams will complement the animal studies.


Eligibility Criteria:
Inclusion Criteria:

* full term pregnancy (\>37 weeks)
* mother age 18-50 years
* intention to practice exclusive breastfeeding for at least 3 months

Exclusion Criteria:

* preterm pregnancy (\<37 weeks)
* multiple delivery
* delivery complications that compromise the well-being of the newborn
* congenital abnormalities of the baby
* pathologies of the mother such as hypertension, HELLP syndrome, thyroids alterations or nephropathies - drugs or alcohol abuse record
* occurrence of mastitis during the study
* mothers practicing tandem nursing
Improving Outcomes in Cardiac Arrest With Inhaled Nitric Oxide

Sudden cardiac arrest (CA) is a leading cause of death worldwide. CA claims the lives of an estimated 300,000 Americans each year. Despite advances in cardiopulmonary resuscitation (CPR) methods, only approximately 10% of adults with CA survive to hospital discharge, and up to 60% of survivors have moderate to severe cognitive deficits 3 months after resuscitation. Most of the immediate and post-CA mortality and morbidity are caused by global ischemic brain injury. The goal of this grant application is to test the hypothesis that resuscitation from cardiac arrest can be improved by improving cerebral oxygenation through inhalation of nitric oxide. This strategy will also improve the chances of return of spontaneous circulation (ROSC), improve short-term survival and neurologic outcome.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years and above
2. In-hospital cardiac arrest as defined by cessation of heartbeat
3. Presence of Endotracheal Tube

Exclusion Criteria:

1. Age below 18 years
2. Absence of Endotracheal Tube
3. Patients with out-of-hospital cardiac arrest
4. Patients involved in trauma and/or patients in the SICU or CTICU
5. Preexisting intra-cerebral lesions such as any head injury (old or new), brain hematoma, cerebral hemorrhage or known frontal lobe disorders such as tumors
6. Any patient with a terminal condition that cannot be treated (specifically any terminal malignancy, end stage lung fibrosis, chronic heart failure with an ejection fraction \<20%)
7. Patients with do not resuscitate and/or do not intubate (DNR/DNI) status
8. Therapeutic window has passed
Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Lidocaine Patch 5% and Lidocaine Medicated Plaster 5% in Healthy, Adult, Human Subjects

The primary objective of this study was to evaluate the adhesion performance of ZTlido® (lidocaine topical system) 1.8% compared to adhesion performance for Lidoderm® (lidocaine patch 5%) and Versatis® (lidocaine medicated plaster 5%).


Eligibility Criteria:
Key Inclusion Criteria:

* Must be healthy based on by medical history, laboratory work, and physical exam with BMI range between 18.00 and 30.00 kg/m2 inclusive.
* Non-smokers
* Be at least 18 years of age
* If childbearing potential, use of acceptable form of birth control
* In the case of females of childbearing potential, have a negative serum pregnancy test

Key Exclusion Criteria:

* Allergy or known hypersensitivity to lidocaine, amide-type local anesthetics, or any component of the product formulation
* Any major medical illness 3 months prior or any significant history or ongoing chronic medical illness
* Presence of any current dermatological condition including psoriasis, eczema, and atopic dermatitis
* Presence of any skin condition such as scratches, cuts, scars, abrasions, excessive hair, tattoos, moles, recently shaved skin, uneven skin texture, irritated (e.g., redness, rash or having blister, etc.) or excessively oily skin at the application areas that may affect the application of the product or adhesion properties of the product.
* History of significant dermatologic cancers (e.g., melanoma, squamous cell carcinoma) except basal cell carcinomas that were superficial and do not involve the investigative site
* History of addiction, abuse, and misuse of any drug
Dopaminergic Enhancement of Learning and Memory in Healthy Adults and Patients With Dementia/Mild Cognitive Impairment

This study aims to determine whether levodopa is effective in boosting learning and memory in healthy subjects and patients with dementia or Mild Cognitive Impairment.

We also examine in healthy subjects using functional magnetic resonance imaging which brain regions mediate improved learning after levodopa administration.

Prior work of our group shows that the dopamine precursor levodopa markedly improves word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind trial, we probe whether administration of levodopa improves learning performance as compared to placebo administration on neuropsychological tests and in an associative learning paradigm. We postulate that levodopa improves learning success and memory performance in healthy subjects, while the effect in patients with dementia or Mild Cognitive Impairment might depend on other factors, including severity of memory impairment.

Eligibility Criteria:
Inclusion criteria for patients with dementia:

* Patients: clinical diagnosis of AD or mild cognitive impairment
* primary language German

Exclusion Criteria for healthy subjects and patients with dementia/MCI:

* Known allergy to levodopa or tetrazine
* History of medication/drug abuse
* Acute nicotine withdrawal or \> 15 cigarettes per day
* \> 6 cups/glasses of coffee, caffeine drinks or energy drinks per day
* \> 50 grams of alcohol per day
* Severe hypertonia (systole \>160 mm Hg)
* Severe arteriosclerosis
* Diabetes, asthma, or glaucoma
* Severe hearing disability
* no focal brain lesions
* Premorbid depression or psychosis
* Medication with dopamine agonists or antagonists
* Parkinsonian symptoms
Multifactorial Intervention on Diabetes (MIDiab Study)

The prevalence of diabetes mellitus has been increasing in recent decades in China, and vascular complication is the major burden in patients with type 2 diabetes. Previous studies demonstrated that only glycemic control was not effective enough to prevent or improve diabetic vascular complications, but guidelines from the Chinese Diabetes Society and other national guidelines recommend an integrated multifactorial treatment approach. In this study, we aim to evaluate the effect on diabetic vascular complications of a multifactorial intervention comprising behavior modification, polypharmacological therapy and periodical monitoring in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

1. 35-75 years old;
2. diagnosed as type 2 diabetes according to the criteria of the World Health Organization in 1999.

Exclusion Criteria:

1. type 1 diabetes，specific types of diabetes，gestational diabetes or pregestational diabetes;
2. acute cardiovascular or cerebrovascular accidents within past 3 months;
3. severe hepatic or renal dysfunction;
4. malignant tumor;
5. allergic history or contraindication for any drugs in trials;
6. taking part in other clinical trials;
7. obviously poor compliance.
The Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women

To evaluate the safety and long-term (approximately one year) effectiveness of the Essure System for Permanent Birth Control ESS505 device in preventing pregnancy.

This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc., Bayer is now the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Female with age range 21 to 44 years
* Subjects who are seeking permanent contraception
* Subjects with body weight within range of 40 - 136 kilograms (90-300 pounds)
* Subjects willing to accept the risk of pregnancy occurring while relying solely on the ESS505 as contraception
* Subjects for whom medical history and physical examination indicates bilateral viable and patent fallopian tubes
* Subjects who are able to comply with the protocol required follow-up visits (e.g., 3 month clinic visit, and the 12-month telephone interview)
* Subjects who provide written informed consent prior to enrolment
* Subjects who have sufficient mental capability to provide clinically relevant and reliable feedback regarding her experience wearing the device
* Subjects agrees that her anonymised personal data will be made available to Study sponsor, requisite regional and international regulatory bodies
* Subjects for whom there are no contraindications for use as described in the ESS505 Instructions for Use (IFU)

Exclusion Criteria:

* Subjects with known proximal tubal occlusion in either fallopian tube
* Subjects who have undergone fallopian tube sterilization procedure
* Subjects diagnosed with unicornuate uterus
* Subjects diagnosed with endometrial or myometrial pathology which may prevent fallopian tube ostia assessment
* Subjects scheduled to undergo concomitant intrauterine procedures at the time of ESS505 placement; IUD removal is not considered a concomitant procedure
* Subjects suspected of being or confirmed pregnant
* Subjects post-partum or has undergone pregnancy termination ≤6 weeks of scheduled ESS505 placement
* Subjects diagnosed with active upper or lower pelvic infection
* Subjects for whom there are one or more contraindications for use as described in the ESS505 IFU
* Subjects have positive pre-procedure pregnancy test
Bioavailability Study of Hemp Phenolics

The aim is to determine the bioavailability of the polyphenol fraction form a commercially available hemp hull fiber at two different amounts in generally healthy adults. Additional objectives include determining specific metabolites produced over a 24 to 48-hour period following the hemp fiber consumption. Subjects will consume a study pudding that will be used to deliver a low and a high dose fiber product. Blood samples will be collected to measure background levels of metabolites. At day 0 participants will consume a low dose study product and day 6 the high dose study product and provide blood samples over an 8 hr period after study product consumption, to be followed by a 24 hr blood sample and 48 hr blood sample. Additionally following the low / high dose study product 24 and 48 h urine samples will be collected.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.50 - 29.99
* non Tobacco or vaping user
* non-user of hemp products within 12 months of first visit
* Willing to stop dietary supplement use within 7 days of visit
* Generally heathy

Exclusion Criteria:

* History or presence of clinically important disorders that may affect subjects ability to participate in the study
* Clinically important GI conditions that potentially interfere with evaluation of study product
* Uncontrolled hypertension or unstable use of antihypertensives
* Recent antibiotic use
* extreme dietary habits
* recent or currently on weight loss regimen
* Known allergy or sensitivity to the study products
* History or presence of cancer in prior 2 years, except for non-melanoma skin cancer
* History of any major trauma or major surgical event within 2 months of first visit
* Pregnancy or willing to become pregnant during study
* Alcohol abuses
* Exposure to any non-registered drug product within 30 days prior to first visit
Using Stories to Address Disparities in Hypertension

The purpose of this study is to determine if patients with high blood pressure are better able to control their blood pressure after watching a DVD about blood pressure.

This project consists of two phases: (1) Collecting of stories and creating a stories DVD; and (2) delivering the DVD in a randomized control trial (RCT). Both phases are described below.

The investigators will make two DVDs of African-American Veterans who will tell their success stories with controlling hypertension (HTN). The investigators want to help African-American Veterans control their hypertension by showing them stories that are interesting and that they can identify with, as well as giving them information about ways they can manage hypertension in their everyday lives. This is important because a disproportionate number of minority patients, including Veterans, have poorly controlled blood pressure. By showing them stories, rather than using more traditional methods of health education, the investigators hope to overcome some typical barriers to HTN control among the African-American population, including: lower levels of health literacy and numeracy, less trust in the medical system, and different (non-medical) models to explain their illness.

The Veteran storytellers will come from three VA sites (Charleston, Chicago, and Philadelphia) and their stories will be chosen based on (1) the proven effectiveness of the strategies they suggest for controlling BP and (2) how authentic they are, or how much they will "ring true" with the experiences of other Veterans, including their struggles and lessons learned.

After the DVD is complete, the investigators will conduct a randomized control trial to evaluate how effective it is in helping vets control their hypertension: 780 African-American vets with uncontrolled hypertension, from the same three VA sites, will participate. Half of them will watch the "Stories" DVD the investigators created; and the other half will watch a control, a DVD with the same medical information but without the narrative component. The investigators will measure their blood pressure (BP) just before they watch the DVD and again six months later. The investigators hypothesize that, six months after enrollment, the Veterans who watched the "Stories" DVD will have greater reduction in BP, as compared with those who watch the control. The investigators will also test the "Stories" DVD's impact on medication adherence and HTN management behaviors.

Eligibility Criteria:
Inclusion Criteria:

* African-American
* Diagnosis of HTN
* Uncontrolled BP as defined by BP \>140/90 twice in the preceding 12 months

Exclusion Criteria:

* active substance abuse
* severe mental illness
* cognitive disabilities that might prevent them from actively or reliably participating in the interviews