cyrilzakka/clinical-trials huggingface dataset:
Effects on Liver Cirrhotic Patients' by a Nurse-led Clinic

This study compare the effects of traditional follow-up by physician with a combined follow-up alternately by physician and nurse-led clinic. The main variable is; health related quality of Life. Participants are randomized into control group or intervention group.

The incidence of liver cirrhosis in Sweden increase mostly due to life style factors. A large need of care is common in the end stage of the disease. Nurse-led clinics for other groups of patients, e.g. coronary heart disease, have shown high quality which has resulted in an established part of the follow-up.

This study is a randomized controlled study at six Swedish hospitals to study the effect of a changed follow-up process for liver cirrhotic patients by adding a nurse-led clinic to follow up by physician. The intervention implies a larger extend of nursing interventions at the outpatient clinic to increase the patient's quality of life, quality of care and reduce the need of inpatient care.

A few hospitals in Sweden offers a nurse-led clinic for liver cirrhotic patients, the interest in other hospitals are raising. Though there is a lack of evidence in nursing intervention within this population and it is still unknown what the effects are for the individual or on the health economy.

Eligibility Criteria:
Inclusion Criteria:

* within the last 24 months diagnosed liver cirrhosis based on clinical investigation, laboratory findings, histology, magnetic resonance imaging, computer tomography, ultrasound or elastography
* followed at one of the six Gastroenterology departments

Exclusion Criteria:

* Insufficient knowledge of the Swedish language
* Persistent hepatic ecephalopathy grades 2-4
* Comorbidity: Chronic obstructive pulmonary disease grade 3-4, Coronary heart disease New York Heart Association Functional Classification class 3-4, Dementia, Actual advanced cancer, Stroke with sequelae, Severe psychiatric disease, Renal failure requiring dialysis
Pediatric Ease of Use ELLIPTA Items

A range of devices has been developed to administer inhaled therapy for asthma, including dry powder inhaler (DPI) devices. ELLIPTA is a DPI that is preloaded with a drug therapy to treat asthmatic subjects. The objective of this study is to revise ease of use items developed for adults to be appropriate for completion by pediatric subjects in future clinical trials and to evaluate the newly developed items in subjects with asthma aged 5 to 11 years and their caregivers. This is a cross-sectional, qualitative study that will involve pediatric subjects with asthma who are currently using an asthma maintenance inhaler and their caregivers. Two rounds of repetitive cognitive interviews will be conducted with 16 subjects in each interview set. Each interview will last approximately 45 minutes. Data provided by pediatric subjects and their caregivers during interview will be collected as field notes and audio recordings which will be transcribed.


Eligibility Criteria:
Inclusion Criteria:

Child inclusion criteria

* Be 5 to 11 years of age
* Have asthma
* Currently use a maintenance inhaler to treat their asthma
* Be willing and able to provide assent
* Be willing and able to participate in a 45-minute interview in English Caregiver inclusion criteria
* Above 18+ years of age
* Be a caregiver (parent or legal guardian) of a pediatric subject with asthma that meets the criteria above
* Be willing and able to provide signed and dated informed consent and parental permission in English
* Be willing and able to participate in a 45-minute interview

Exclusion Criteria:

* Nil
Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort

The Dallas Heart Study (DHS-1) is a large, multi-ethnic, population-based epidemiological study designed to identify determinants of atherosclerotic heart disease (ASHD) in a representative United States (US) urban environment. This study completed enrollment in 2003.

Our objective is to pinpoint factors contributing to progression:

1. from health to ASHD risk;
2. from ASHD risk to subclinical ASHD; and
3. from subclinical to clinical ASHD.

Identification of the critical factors in these transitions will enable targeted implementation of appropriate therapy to interdict before clinical ASHD develops.

Early medical intervention in asymptomatic individuals at risk is the most effective strategy to combat atherosclerotic heart disease (ASHD). The major roadblock to effective ASHD prevention is that conventional tools to assess ASHD risk are inadequate and new methods are needed to identify susceptible individuals before the disease process is established. Other successful public-health screening programs have incorporated direct imaging procedures (e.g. mammography, colonoscopy); yet in ASHD, direct imaging of the vasculature has not been incorporated into the risk stratification algorithms.

The Dallas Heart Study (DHS-1) is a large, multi-ethnic, population-based epidemiological study designed to identify determinants of ASHD in a representative US urban environment. This study completed enrollment in 2003.

In DHS-2 we will transform the Dallas Heart Study from a cross-sectional health survey (DHS-1) into a longitudinal cohort study (DHS-2). We will perform state-of-the-art cardiovascular (CV) imaging coupled to biomarkers, genetic markers and classical ASHD risk factors. We will repeat the detailed clinical phenotyping performed between 2000-2003 to capture interval changes in ASHD risk and disease burden. Our objective is to pinpoint factors contributing to progression:

1. from health to ASHD risk;
2. from ASHD risk to subclinical ASHD; and
3. from subclinical to clinical ASHD.

Identification of the critical factors in these transitions will enable targeted implementation of appropriate therapy to interdict before clinical ASHD develops.

Eligibility Criteria:
Inclusion Criteria:

* Age 35-70
* Participant in DHS-1 study completing visit 2 (blood sampling) and visit 3 (clinic visit)
* Provision of informed consent

Exclusion Criteria:

* None--population study
Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty

To prove that anterior approach total hip arthroplasty using the HANA table can be performed with little, if any, need for opioids using a combination of education, optimized pre op and post op pain protocols and optimized recovery tools.

Methods:

Data Collection:

* pre-op assessment/physical therapy evaluation
* post op assessment - PACU, phase II (Prior to discharge)
* phone calls after discharge (post op day 1, 2, 3)
* follow up assessment in surgeon's office (3 and 6 weeks post op)
* Ortech
* Swiftpath
* HOOS jr

Pre-optimization:

* All patients enroll in SwiftPath education program
* Optimized BMI, hemoglobin, albumin, glucose control, A1C and blood pressure control

Total Joint procedure:

-anterior approach using the HANA table THA preformed with intra-articular block

Pain Management regimen:

* Pre op PT teaching
* post op multimodal pain regimen

Eligibility Criteria:
Inclusion Criteria:

* Elective total hip arthroplasty
* unilateral
* patient surgeries scheduled to be performed at the hospital and surgery center
* patients must enroll in SwiftPath
* Ability to read and understand English

Exclusion Criteria:

* Patient diagnosis of schizophrenia, bipolar disease, dementia
* previous burn to affected extremity
* BMI \> 40
* Hemoglobin \<12 female, \<13 male
* Albumin less than 3.5
* A1C \>8.0
Aspheric Monofocal Intraocular Lens in Pediatric Patients

To evaluate the performance a new aspheric monofocal intraocular lens (IOL) with higher order aspheric optic for far, intermediate, and near vision, in pediatric patients after monolateral cataract surgery.

thirteen patients (mean age 7.6±3.8 years) who underwent cataract surgery and simultaneous implantation of the Tecnis Eyhance ICB00 IOL were evaluated. Visual acuity was assessed three months after surgery for distance (CDVA), intermediate (CIVA) and near visual acuity (CNVA).

Eligibility Criteria:
Inclusion Criteria:

* monolateral cataract

Exclusion Criteria:

* other ocular diseases
* systemic diseases
Safety and Efficacy of Evolocumab in Combination With Statin Therapy in Adults With Diabetes and Hyperlipidemia or Mixed Dyslipidemia

The primary objective of this study was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) in combination with statin therapy (atorvastatin) on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in diabetic adults with hyperlipidemia or mixed dyslipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Males and females with type 2 diabetes (receiving pharmacologic treatment for at least 6 months or longer) with stable diabetes therapy
* Lipid-lowering therapy must be unchanged for at least 4 weeks or more
* Subjects receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 100 mg/dL
* Subjects not receiving statin therapy at screening must have a fasting LDL-C of greater than or equal to 130 mg/dL

Exclusion criteria:

* New York Heart Association (NYHA) class III or IV heart failure
* Uncontrolled cardiac arrhythmia
* Uncontrolled hypertension
* Type 1 diabetes or poorly controlled type 2 diabetes
* Uncontrolled hypothyroidism or hyperthyroidism.
Nebivolol and the Endothelin (ET)-1 System

The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.

1. The investigators hypothesize that nebivolol will reduce ET-1-mediated vasoconstrictor tone in adult humans with elevated blood pressure to a greater extent than either metoprolol or placebo.
2. The investigators further hypothesize that reducing ET-1 vasoconstrictor activity contributes to the improvement in endothelial vasodilator function associated with nebivolol.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be men and women of all races and ethnic backgrounds aged 45-65 years.
* Subjects will be prehypertensive/hypertensive defined as resting systolic blood pressure \>130 mmHg and \< 160 mm Hg and/or diastolic blood pressure \>80 mmHg and \< 100 mm Hg.
* All of the women in the study will be postmenopausal (at least 1 year from last menstrual cycle) and not receiving hormone replacement therapy (HRT) currently or in the preceding 3-year period.
* Lastly, candidates will be sedentary as determined from the Stanford Physical Activity Questionnaire (\<35 kcal/wk) and will not have engaged in any program of regular physical activity for at least 1 year prior to the study.

Exclusion Criteria:

* Candidates who smoke (currently or in the past 7 years), report more than low-risk alcohol consumption as defined as no more than 14 standard drinks/wk and no more than 4 standard drinks/day for men and 7 standard drinks/wk and 3 standard drinks/day for women (a standard drink is defined as 12 ounces of beer, 5 ounces of wine, 1½ ounces of 80-proof distilled spirits)
* Potential candidates who are taking cardiovascular-acting (i.e. statins, blood pressure medication an aspirin) medications will not be eligible.
* Fasting plasma glucose \>126 mg/dL.
* Potential candidates with a resting heart rate of \< 50 beats/minute will be excluded.
* Use of hormone replacement therapy.
* In hypertensive subjects, a seated systolic blood pressure greater than 160 mmHg or a seated diastolic blood pressure greater than 100 mmHg.
Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece

The Enhanced Recovery After Surgery (ERAS) program includes preoperative counseling, fasting avoidance, non-opioid analgesia, fluid balance, normothermia and early mobilization. ERAS pathways were developed to reduce hospital length of stay, reduce costs and decrease perioperative opioid requirements, and be beneficial for patients. We propose the hypothesis that the ERAS pathway could reduce the length of stay (LOS) in hospital for patients undergoing major gynecologic oncology surgery (MGOS).

Patients were randomly allocated in two groups: An ERAS pathway group including preoperative counseling, early feeding/mobilization, and opioid-sparing multimodal analgesia; and a classic model group of post operative recovery as control.

The Gynecological Cancer of the inner genital organs includes ovarian cancer, endometrial and cervical cancer and its therapeutic approach is surgical removal of the organ with cancer.

The last decade has developed various postoperative recovery protocols aimed at safe and rapid recovery of the patient after a surgery and early discharge from the hospital. These protocols are known as ERAS (Enhanced Recovery After Surgery) protocols or Fast-Track (FT) and combine various evidence-based perioperative care techniques.

The ERAS protocols include specific approaches preoperative, intraoperative and postoperative, by the multidisciplinary team (surgeon, anesthetist and nurse), and aim at reducing the postoperative stress and pain, fasten the feeding and the mobilization of the patient after the surgery and rapid the hospital discharge.

This trial is designed to evaluate the superiority of the ERAS pathway to conventional non-ERAS clinical practice in reducing the LOS. The results may provide new insight into the clinical applications of the ERAS pathway for MGOS.

This doctoral thesis aims to compare the effectiveness of the Protocol ERAS against the classical model of recovery, in the postoperative recovery of patients with Gynecological Cancer undergoing MGOS, in a Public Oncology Hospital in Greece.

The importance of ERAS programs is expected to emerge in the length of hospital stay, in pain control, in perioperative stress, in the early feeding and mobilization of patients who have undergone MGOS.

Eligibility Criteria:
Inclusion Criteria:

* Greek language speakers
* Have complete mental clarity
* Age \>18 years

Exclusion Criteria:

* Refusal to sign consent
* Patients receiving treatment for chronic pain
* Patients receiving antipsychotic therapy, Psychopathy
* They have acute or chronic kidney and / or liver disease
* History or family history of malignant hyperthermia
* Known allergy to propofol, desflurane, or any other anesthetic agent
* Impairment of cognitive function or communication
* History of postoperative delirium
Navigation With X3 vs Non-Navigation With X3 Study

The purpose of this study is to compare the effect of the large head in THA with a navigation system and without a navigation system.


Eligibility Criteria:
Inclusion Criteria:

1. Patient who is a candidate for a primary total hip arthroplasty (THA) with cementless acetabular and femoral components.
2. Patient who has a diagnosis of degenerative joint disease and no bacterial infectious disease.
3. Patient who is age 20 or over.
4. Patient who signed an Institutional Review Board (IRB)-approved, study specific Informed Patient Consent Form.
5. Patient who is willing to and able to comply with postoperative scheduled evaluations.

Exclusion Criteria:

1. Patient who has a bacterial infectious disease or has a high risk of a bacterial infection.
2. Patient who requires revision surgery of a previously implanted total hip arthroplasty.
3. Patient who is morbidly obese, defined as having a Body Mass Index (BMI) \> 45.
4. Patient who is or may be pregnant female.
5. Patient who has neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
6. Patient with diagnosed systemic disease (i.e. Paget's disease, renal osteodystrophy).
7. Patient who is immunologically suppressed or receiving chronic steroids.
8. Patient who is judged ineligible with specific reason by primary doctor.
Prevention Program Promoting Self Resilience,Positive Self-Image and Body Image Among Adolescence Aged 15-17

The study was a group randomized controlled trial. Within each school Classes of high school students were allocated by randomization to the intervention or control group by a function Randomization in Excel program. Outcomes were measured by questionnaire at pre- intervention, post-intervention and 3-month follow-up. The study protocol was approved by Tel Hai college institutional review board. Parents of all participants, in the intervention and in the control group, received information about the program and the study and were choose whether to provided informed consent or not.

Participants and setting Two high schools were recruited for the study, in each school classes from grades 9th and 10th were chosen to participate in the study all mixed gender classes. The two high schools are in northern Israel, one in a rural area and the second in a small city, both serving the Jewish population. The size of the schools were similar. All data were collected within the school setting.

Program description "Towards a more resilient self" is an interactive, cognitive behavior program aiming to address low resilience, low self-esteem and body dissatisfaction. The program contains a range of coping strategies to help adolescents improve resilience, self-esteem and body image. The program consists of nine 90-min sessions delivered by one group leader in the presence of the classes' teachers. Participants in the control group received one session of 90 minutes with health nutrition education.

Eligibility Criteria:
Inclusion Criteria:

* Participants who filled out the questionnaires before and after the program, and if their parents have signed a letter of agreement

Exclusion Criteria:

* Participants who do not completed the questionnaires at least twice
Brain Mechanism and Outcome of Surgical Intervention of Conductive Hearing Loss.

This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data.

This study explores the brain region activation and remodeling of poor connections of brain regions in the postoperative outcomes of conductive hearing loss patients with tinnitus by comparing pre - and post-operative audiological assessment, tinnitus assessment and EEG data. Including audiological assessment (pure tone audiometry, speech test), tinnitus assessment (tinnitus matching, tinnitus handicap inventory, tinnitus function index, visual analogue scale)and non-invasive brain imaging assessment (EEG, fNIRS).

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 60 years;
* diagnosed with conductive hearing loss with tinnitus;
* treated with surgery;
* able to cooperate with all Chinese version evaluation;
* right-handed.

Exclusion Criteria:

* Pure tone audiometry indicates that the average pure tone hearing threshold (500Hz, 1kHz, 2kHz, 4kHz) is \> 91dB HL;
* acoustic neuroma, nasopharyngeal carcinoma;
* hearing loss caused by noise or drugs.
A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency

This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first conduct an exploratory single dose study in pediatric patients to assess safety and tolerability in this patient population. In addition this will add pediatric data to facilitate the prediction of the optimal therapeutic dose to be tested in repeated dose phase 2b trials in children, using PK/PD modeling

The study terminated on 10-Dec-2007. Pfizer's decision to terminate the program was due to cases of injection-site lipoatrophy that were reported in the clinical Phase 2 studies after a single injection of PHA 794428.

Eligibility Criteria:
Inclusion Criteria:

* 1.Male and female children with a minimum age of 6 years
* 2. Prepubertal as defined by Tanner staging
* 3. Growth hormone deficiency

Exclusion Criteria:

* 1. PGHD patients with uncontrolled pituitary tumor growth
* 2. Tumors within 3 mm of the optic chiasm
* 3. Serum ALT and/or AST \>= 1.5 times the upper limit of normal range
Health and Road Safety: Influence of Drugs Use and Health Status

In France, drugs affecting driving ability directly or by indicating at-risk diseases are classified in a 4-level standardized classification associated with a graded pictogram.

When the French authorities required this graded pictogram, they commissioned the CESIR-U1 study, a study designed to describe the use of labelled medicines by drivers involved in serious road accidents (hospitalization \> 24h). This study, conducted in Bordeaux, Limoges and Toulouse, recruited 679 drivers involved in serious road accidents. When the responsibility of the driver is taken into account, it appears that the association of risk factors (alcohol, sleep, ...) and the use of labelled drugs increases this responsibility. Even though labelled medicines seemed slightly more at risk than unlabelled ones, this did not reach significance.

This conclusion is different from the conclusion of CESIR-A, a data linkage study of the police and the health insurance databases which showed a correlation between the use of grade 2 or 3 labelled medicines and driver responsibility.

This difference between CESIR-U and CESIR-A could be related to a lack of power or to the characteristics of the subjects included (mostly young men and motorcycle drivers). That is why it was thought interesting to increase the size of the sample and to include non serious road accidents (hospitalization \< 24 hours) that represent around 73% of accidents.


Eligibility Criteria:
Inclusion Criteria:

* Driver involved in a road accident and admitted in an emergency department
* Aged over 18 years
* Able to respond to a structured questionnaire
* Having agreed to participate in the study

Exclusion Criteria:

* Minors
* Passenger
* Pedestrian
* Discharge or transfer to another hospital/clinic before the interview
ADSC Injections for Pain Management of Osteoarthritis in the Human Knee Joint

This safety and feasibility study used autologous adipose-derived stromal cells (ADSC), the stromal vascular fraction (SVF), to treat 8 osteoarthritic (OA) knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under Institutional Review Board (IRB) approved protocol.

This safety and feasibility study used autologous adipose-derived stromal cells, the stromal vascular fraction, to treat 8 osteoarthritic knees in 6 patients of grade I to III (K-L scale) with initial pain of 4 or greater on a 10 point scale, under IRB-approved protocol. Evaluation of the safety of intra-articular injection of the stromal vascular fraction cells was the primary objective of the study. Adipose-derived stromal vascular cells were obtained through enzymatic disaggregation of lipoaspirate, resuspended in 3 ml of Lactated Ringer's Solution, and injected directly into the intra-articular space with a mean of 12 million viable nucleated SVF cells per knee.

Eligibility Criteria:
Inclusion Criteria:

* voluntarily provided written Informed Consent
* ages 20-70
* male or female
* grades I-III radiologically documented OA of one or both knees
* American Society Anaesthesiologists (ASA) physical status class I-II and a • BMI less than 35
* knee pain graded as greater than 3 out of 10 on screening questionnaire
* able to speak, read and understand English -

Exclusion Criteria:

* patient parameters falling outside of the inclusion criteria
* current oral or parenteral steroid or blood thinner use
* hyaluronic acid-based injection to the affected knee joint within the previous six months
* corticosteroid injection to the affected knee joint within the previous three months
* end stage (Grade IV) OA