cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Balance and Movement in Order to Prevent the Risk of Falling in the Post-operative Period

This study aims to identify, in patients undergoing hip and knee joint replacement, the functional evaluation tools predictive of the risk of falling upon admission to the orthopedic department and to correlate the results obtained with clinical evaluation scales that are generally used for fall risk stratification and the number of falls actually occurring both in the orthopedic department and in the rehabilitation department.

The goal of this prospective interventional cohort study is to identify functional assessment tools predictive of the risk of falling in patients undergoing hip and knee joint replacement surgery upon admission to an orthopedic department and to correlate the results obtained with the clinical rating scales generally used for the risk stratification of fall. All patients upon admission to the Orthopedic Department of the DRS (Rizzoli Sicily Department), throughin the pre-operative setting will undergo an assessment of mobility level, dynamic stability and co-ordination: Test UP and GO, Il Four Square Step Test, Stabilometric Analysis. After admission to the DRS Rehabilitation Medicine Department, all patients will receive an evaluation, which is currently used, consisting of: History of fall risk through multidimensional assessment, Compilation of ICF(International Classification of Functioning, Disability and Health) and Barthel Index. The following ratings will also be added: Compiling the Morse scale, Pharmacological history, CIRS (Cumulative Illness Rating Scale), The scores obtained from the various measures used in the patients will be correlated to any falls recorded during hospitalization with the aim to obtain a stratification of falls risk in those patients.

Eligibility Criteria:
Inclusion Criteria:

* The patient's ability to perform the required tests, the understanding of the language of the study
* Patients of both sexes between the ages of 50 and 85;
* Patients candidates for hip and knee joint replacement in the Orthopedic Department of the DRS.

Exclusion Criteria:

* Non-ambulatory patients, patients with amputation of one of the 2 lower limbs,
* Serious neurological and/or psychiatric diseases
* Patients with vestibular deficits
Retrospective Prospective Multicentric Clinical Follow up of Patients After Being Treated With TricValve®

Retrospective prospective Multicentric clinical follow up of patients with severe tricuspid regurgitation after being treated with the TricValve® Transcatheter Bicaval Valves System.

The study shall enrol subjects who were treated with the TricValve® Transcatheter Bicaval Valves System® in the Inferior Vena Cava and Superior vena cava. On compliance with the inclusion / exclusion criteria the subject will be enrolled for the observational study.

The study duration for the individual subject will be up to 5 year follow up. The follow-up should be made through pre-established periodic clinical consultations at discharge, 1 month, 6 months, 1 year follow up to 5 years after the procedure. In the consultations, routine exams such as hemogram, renal function, electrocardiogram and echocardiography in order to ascertain the bioprosthesis functioning and its hemodynamic profile are documented as per clinical routine practise.

Eligibility Criteria:
Inclusion Criteria:

* Successful treatment with TricValve Transcatheter Bicaval Valves System
* Patient/patient's authorized legal guardian gives his consent to participate in the study and signed the corresponding inform consent

Exclusion Criteria:

* no exclusion criterion
Understanding the Natural History of REM Sleep Behavior Disorder

The purpose of this research study is to determine if safe, simple and non-invasive tests such as an electrocardiogram (EKG), a smell test, or a blood test could be used to identify neurological disorders before typical symptoms occur. Researchers believe that early identification of these disorders could lead to treatments to prevent, delay, or slow the development of one of more of these diseases. Some people with REM sleep behavior disorder (RBD) may go on to develop Parkinson's disease or another related neurological disorder, but many do not.


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic REM sleep behavior

Exclusion Criteria:

* Parkinson's disease
* Alzheimer's disease
* Multiple system atrophy
* Dementia
* Minors
Local Evaluation of the Saint Francis Ministries Fatherhood FIRE Program

This study is the local process and impact evaluation for Saint Francis Ministries' Fatherhood FIRE Program.

This project is based on federal legislation that requires evaluation of a program being implemented and delivered by Saint Francis Ministries, a community-based non-profit organization serving children and families. Saint Francis Ministries received federal funds to expand and deliver the Fatherhood FIRE Program to community-based and justice-system involved fathers in their service area. The FIRE program, which stands for Family-Oriented, Interconnected, Resilient, and Essential, aims to promote responsible and positive fatherhood parenting practices and develop and maintain healthy relationships with their partners and other co-parents (e.g., mothers of their children). Evaluation of the program is a condition of Saint Francis Ministries' grant award from the U.S. Department of Health and Human Services. The KU evaluation team at the School of Social Welfare has been contracted by Saint Francis Ministries to conduct the evaluation. The evaluation will be carried out in two parts: 1) a process evaluation and 2 an outcomes evaluation. The process and target populations for both the process and outcomes components are as follows. PROCESS EVALUATION: The process study involves individuals involved in the implementation of the Fatherhood FIRE program at Saint Francis Ministries. Specific populations eligible for inclusion in the process evaluation include: (1) implementation teams facilitating the Fatherhood FIRE program in three states in Saint Francis Ministries service area (Kansas, Nebraska, \& Texas), (2) members of the Fatherhood FIRE Data, Assessment, and Dissemination Workgroup, an advisory group comprised of Saint Francis program administrators and the evaluation team charged with planning and overseeing data collection, evaluation, and dissemination efforts, and (3) the evaluation study team. OUTCOMES EVALUATION: Fathers ages 18 and older who are not incarcerated and are enrolled and participating in the Fatherhood FIRE program. To be eligible for inclusion in the evaluation study, program participants must not be incarcerated, have children up to age 24, and may be living with or apart from their children. Eligible participants may be biological parents, adoptive or foster parents, or other caregivers in the parenting role if they have children who meet the age criteria.

Eligibility Criteria:
Inclusion Criteria:

* Fathers with children up to 24 year old
* Fathers participating in the Saint Francis Fatherhood FIRE Program

Exclusion Criteria:

* Fathers who are incarcerated
Taurine in Periodontitis and Aging

Aging leads to a decline in physiological functions and increases the risk of chronic diseases. Periodontitis is a chronic inflammatory disease that causes progressive destruction of the tissues supporting the teeth. Taurine, an amino acid with anti-inflammatory and antioxidant effects, might impact both periodontitis and aging. This study investigated taurine, SIRT1, and TNF-α levels in saliva and blood of 66 healthy people in different age groups, with or without periodontal disease. The findings showed that young people with healthy periodontal status had higher levels of taurine and SIRT1 compared to others. TNF-α, a marker of inflammation, was linked to the severity of periodontitis and may help identifying it in younger individuals. Overall, higher TNF-α levels are associated with periodontal inflammation, while taurine levels decrease with age-related inflammation.


Eligibility Criteria:
Exclusion Criteria:

* ages 18-25 or 45-64
* use of antibiotics, anti-inflammatory drugs, immunosuppressants, beta-blockers, calcium channel blockers, or anticoagulants within the last 6 months
* presence of diabetes, rheumatoid arthritis, or other systemic conditions such as cardiovascular, renal, hepatic, and neurodegenerative disorders
* pregnancy or lactation
* alcoholism
* smoking
* nonsurgical periodontal treatment in the past 6 months or surgical treatment in the past 12 months
* having less than 20 natural teeth, excluding third molars
* use of orthodontic appliances
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 years and older.The lower age limit may be higher if legally required in the participating country
* Women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active.
* Subjects with type 2 diabetes mellitus fulfilling at least 1 of the following criteria

  * are on oral antidiabetics and / or insulin,
  * have a documented fasting glucose \>/= 7.0 mmol/L in the medical history,
  * have a 2 hour plasma glucose \>/=11.1 mmol/L during an oral glucose tolerance test in the medical history, or
  * have a glycated hemoglobin (HbA1c) \>/=6.5% \[National Glycohemoglobin Standardization Program (NGSP) / Diabetes Control and Complications Trial (DCCT)\] in the medical history or at the run-in visit
* Subjects with a clinical diagnosis of diabetic nephropathy (DN) based on at least 1 of the following criteria:

  * Persistent very high albuminuria defined as urinary albumin-to-creatine ratio (UACR) of \>/=300 mg/g ( \>/= 34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) \>/=30 mL/min/1.73 m² but \< 90 mL/min/1.73m² (Chronic Kidney Disease Epidemiology Collaboration, CKD EPI) (mL = milliliter; min = minute; m2 = square meter; g = gram; mmol = millimole) or
  * Persistent high albuminuria defined as UACR of \>/=30 mg/g but \<300 mg/g in (\>/=3.4mg/mmol but \<34 mg/mmol) in 2 out of 3 first morning void samples and eGFR \>/=30 mL/min/1.73 m² but \< 90 mL/min/1.73m²
* Subjects treated with an angiotensin-converting enzyme inhibitor (ACEI) and/or angiotensin receptor blocker (ARB) for at least 3 months without any adjustments to this therapy for at least 4 weeks prior to the screening visit
* Serum potassium \</= 4.8 mmol/L at both the run-in visit and the screening visit

Exclusion Criteria:

* Non-diabetic renal disease
* Glycated hemoglobin (HbA1c) \>12% at the run-in visit or the screening visit
* UACR \>3000 mg/g (339mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
* Hypertension with mean sitting systolic blood pressure (SBP) \>/=180 mmHg or mean sitting diastolic blood pressure (DBP) \>/=110 mmHg at the run-in visit or mean supine SBP \>/=160 mmHg or mean sitting DBP \>/=100 mmHg at the screening visit
* Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
* Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
* Dialysis for acute renal failure within the previous 6 months prior to the run-in visit
Regional COVID Epidemiology in England (RECEDE)

The COVID-19 pandemic has exposed the unwanted variation in outcomes as evidence by Public Health England's report on increased mortality in regions of the country. For example, UHDB, in East Midlands, has reported a high crude mortality as compared to other Trusts in the region.8 There may also have been variation in the incidence of complications of COVID-19 in the form of AKI, which may have influenced mortality. Variation in outcomes may be because of various factors - differing population demographics, underlying health conditions in the population, deprivation, physician preference and knowledge and ethnic diversity. Unwanted variation is care that is not consistent with a patient's preference or related to \[their\] underlying illness. It is important to understand the reason for unwanted variation in outcomes associated with COVID-19 to minimise patient harm and reduce morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

This study will have two work packages (WP). Work Package 1 (WP1): Regional epidemiology of COVID-19 in England All patients who are admitted to hospital with COVID-19 infection between 1st March 2020 and 30th June 2020 and who meet following criteria will be included

1. Diagnostic code for COVID-19 (U07.1) in any of the 20 diagnoses codes
2. Adult patients greater or equal to 18 years of age.

Work Package 2 (WP2): Epidemiology of COVID-19 associated AKI in England All patients who are admitted to hospital with acute kidney injury (AKI) between 1st March 2020 and 30th June 2020 and who meet following criteria will be included

1. Diagnostic code for AKI (N17) in any of the 20 diagnoses codes
2. Adult patients greater or equal to 18 years of age.

Exclusion Criteria:

WP1:

The following patients will be excluded from the study

1. Patients not admitted to the hospital
2. Paediatric patients \< 18 years of age

WP2:

The following patients will be excluded from the study

1. Patients not admitted to the hospital
2. Paediatric patients \< 18 years of age
3. Patients on chronic maintenance haemodialysis or peritoneal dialysis
Observational Study of How Patients Take Eye Drops

This study is interested in monitoring how patients take eye drops, both through video-recordings and adherence monitoring, as well as their perceptions about their eye medications; including the dosing schedules, instillation techniques and effect on their disease.


Eligibility Criteria:
Inclusion Criteria:

* \>18 year old
* currently taking 1 or more hypotensive topical eye drops takes drops in the right eye for more than 6 months expect to continue drop use for the next 3 months
* subjects instill their own eye drops
* subject is able to take HVF tests
* subject will expect to complete the 3 months enrollment period

Exclusion Criteria:

* unable/unwilling to instill own medications
* eye drops are discontinued
* unable to take HVF test
* unable to complete follow-up
* investigators discontinue subject for safety reasons
* not using drops in left eye
Strategy Therapy on Cancer Therapy-Related Cardiac Dysfunction

The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. The investigators planned an earlier initiation of Sacubitril/Valsartan treatment on breast cancer and lymphoma patients before the chemotherapy, and starting therapeutic intervention by Sacubitril/Valsartan once the heart damage sign appeared via novel echocardiography. The investigators aim to assess the protective and therapeutic benefit of cardioprotective drugs on the cardiotoxicity of anti-cancer therapy.

The investigators use the cancer registration system of National Cheng Kung University Hospital to timely screen and evaluate those patients having breast cancer or lymphoma to enroll patients to participate in this clinical trial. Also, the Patient Recruitment System support to complete the patients' database. The investigators cooperate with other hospitals in South Taiwan to carry on an early phase clinical trial, named "Strategy by novel anti-heart failure therapy on early phase Cancer Therapeutics-Related Cardiac Dysfunction (CTRCD) patients" focusing on the either preventive strategy to earlier initiation of Sacubitril/Valsartan treatment on breast cancer and lymphoma patients before the chemotherapy, and starting therapeutic intervention by Sacubitril/Valsartan once the heart damage sign appeared via novel echocardiography, and collect clinical and genetic information from the enrolled patients. These patients randomized into 2 groups: cardioprotective drug vs. placebo. The regular assessment of cardiac function is as following: baseline (prior to anti-cancer treatment) and every 3 months. Thereafter. The investigators aim to assess the protective and/or therapeutic benefit of cardioprotective drugs on the cardiotoxicity of anti-cancer therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are newly diagnosed with breast cancer or lymphoma and never accepted anti-cancer therapy
* Age 20-65 years old
* Systolic blood pressure ≥ 110 mmHg

Exclusion Criteria:

* End-stage renal disease (estimated Glomerulus Filtration Rate \<15 mL/min/1.73 m2)
* Echocardiography Baseline left ventricle ejection fraction \< 50%
* Allergy history to angiotensin receptor blockers
* Life expectancy \< 1 year
* Pregnancy
* Unwilling to participate in this clinical study
Effects of Maternal Interpretation Biases on Child Anxiety and Related Responses

The purpose of this study is to expand our understanding of the intergenerational transmission of cognitive risk for childhood anxiety disorders by examining whether changes in maternal interpretations of situations result in changes in child interpretations and child anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Children ages 8-12
* Children with primary diagnosis of anxiety disorder
* Mothers with clinical levels of anxiety symptoms on the Depression, Anxiety, and Stress Scales (DASS; Lovibond \& Lovibond, 1995)

Exclusion Criteria:

* Physical disability impairing ability to use a computer
* Intelligence Quotient \<80
* Reading comprehension and fluency composite \<75
* Concurrent primary diagnosis of any non-anxiety disorder
* Currently receiving psychological or pharmacological treatment for anxiety
* Danger to self/others
* Non-English speaking child/parent
* Maternal current involvement in cognitive-behavioral therapy
* Maternal changes in pharmacological treatment in the 12 weeks prior to enrollment.
IVES for Treatment of UUI and OAB

The pilot study is intended to show the efficacy of intravesical electrical stimulation in treating overactive bladder with or without frequency and/or urgency urinary incontinence.

The EMED Technologies detrusetTM intravesical electrical stimulation (IVES) catheter is indicated for use with the EMED detrusanTM 500 electrical generator for the treatment of overactive bladder and urge urinary incontinence (UI) in women who are not satisfied with or cannot tolerate other conservative treatments. EMED is interested in conducting a prospective randomized multi-center study of IVES therapy vs conventional UI treatments. In order to gain sufficient knowledge of the treatment effect and variability of IVES therapy to power an RCT, a pilot study will be initially conducted.

The pilot study is intended to show the efficacy of IVES in treating overactive bladder with or without frequency and/or urgency urinary incontinence with safety profile of IVES being no worse than with standard urological catheters.

A primary endpoint at 3 months showing reduction in incontinence events via a 7-level patient global impression of improvement will be established. Secondary endpoints will include PCI for subsets of symptoms, 3 day voiding diary, and patient satisfaction questionnaires.

Follow up at end of therapy and 3 months from the first therapy session will be conducted. 6-month, 9-month, and 12-month follow up can be conducted to establish durability of IVES therapy if it is found to be effective at 3 months after the first treatment

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-90 years old
* Urinary urge incontinence OR overactive bladder
* Prior trial of medical treatment for UUI or OAB

Exclusion Criteria:

* pelvic organ prolapse greater than stage 1
* multiple sclerosis
* parkinson's disease
* spinal cord injury
* long-term DM type I
* prior surgeries that may affect innervation of the detrusor nerves or the spinal cord
* pregnancy
* pacemaker/defibrillator
* PVR \>150ml
* dementia
* Stress urinary incontinence
* intravesical botox injection within 1 year, PTNS within 6 months, or medical treatment for OAB within 3 weeks; bulking agent injection within 6 months
Subjects With T2D or at Risk of T2D Cohort Follow-up

The main objective of this study is to prospectively follow the subjects included in "Descendance" cohort and to describe the occurrence of type 2 diabetes in non-diabetic subjects, which will allow us to iteratively update the "Descendance" Type 2 Diabetes risk prediction model.

High risk families will be prospectively follow in order to better understand the risk of transmission of type 2 diabetes from one generation to another. The cohort will also allow us to collect additional data on diabetic patients.

The monitoring of the cohort will take place for at least 10 years with a follow-up of all participants every three years. To detect individuals who develop dysglycemia during the study, a glucose tolerance test (GTT) and HbA1c measurement will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Subjects have participated in the Descendance study
* Subjets who sign informed consent to participate in the study

Exclusion Criteria:

* Subjects not enrolled in Descendance study
* Subjects refusing to participate
* Pregnant or breastfeeding
* Subjects in emergency situations, under legal protection or unable to provide informed -consent
* Subjects lost to follow-up or died
Digital PCR for Quantifying Periodontal Pathobionts

Comparison of quantitative polymerase chain reaction (qPCR) and digital polimerase chain reaction (dPCR) quantification of subgingival plaque samples.


Eligibility Criteria:
For inclusion, each subject had to be systemically healthy and aged 20 to 80 years. Subjects were excluded if they: had less than 5 teeth in each jaw quadrant, regularly used a mouthwash as part of their oral hygiene routine, had received antibiotics during the last 6 months or during the study period, were pregnant or lactating, had a known systemic illness (i.e. HIV/AIDS, diabetes mellitus, cancer, diseases of bone metabolism, diseases affecting wound healing) or were treated with immunosuppressants, chemotherapy, radiation, calcium antagonists, antiepileptics and non-steroidal anti-inflammatory drugs.