cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Tele-exercise Training on Cardiorespiratory Fitness in Patients With Cardiometabolic Multimorbidity

This trial aimed to assess whether assumed increase in physical activity after tele-exercise training can improve cardiorespiratory fitness of patients with cardiometabolic multimorbidity.

A parallel-group randomized controlled trial was conducted. Eligible patients with cardiometabolic multimorbidity were randomized 1:1 to either experimental group (EG, received a tele-exercise training program) or control group (CG, usual care only). The intervention encompassed tele-exercise training program (30 min/session, 3 sessions/week) and weekly remote monitoring for maintenance of exercise. Physical activity and cardiorespiratory fitness were assessed at baseline and 12 weeks. Generalized estimating equations were used to examine the intervention effects via the interaction of time and group.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnoses of cardiometabolic multimorbidity, defined as the presence of two or more cardiometabolic conditions (i.e., hypertension, type 2 diabetes, hyperlipidaemia, heart disease, metabolic syndrome, or gout)
* Aged 18-80 years
* Able to speak and understand Mandarin
* Able to walk without assistance
* Had mobile phones and could easily access the Internet

Exclusion Criteria:

* Not match the diagnosis of cardiometabolic multimorbidity; and a history of arrhythmia, cancer, end-stage renal disease with dialysis, being diagnosed with mental illness, recent stroke within 6 months
* Not able to speak and understand Mandarin
* Not able to walk independently or inability to participate due to comorbid neurological, musculoskeletal conditions that produce moderate-to-severe physical disability
* Did not have mobile phones or could not access the internet at home and whenever necessary
Preoperative Oral Hydration in the Ambulatory Arthroplasty Population

The purpose of this study is to investigate if the consumption of a complex carbohydrate drink preoperatively, decreases the length of stay and causes for failure to launch in patients undergoing ambulatory total joint arthroplasty.

The way total joint arthroplasty is practiced continues to evolve as CMS removed total hip arthroplasty (THA) from the inpatient-only list and added total knee arthroplasty (TKA) to the ASC Covered Surgical Procedures List (CPL) in 2020. Thus, surgeons must find subtle interventions that improve patient outcomes while minimizing the risk of adverse reactions. Current literature has not assessed the influence of preoperative hydration, using a complex carbohydrate drink, on the same-day discharge rate and causes for failure to launch. Considering variabilities in perioperative fluid management leading to postoperative nausea, vomiting, and dizziness, the investigators seek to reduce the incidence of these events by optimizing patients using a preoperative oral hydration protocol, reducing the length of stay, and improving same-day discharge rates.

Eligibility Criteria:
Inclusion Criteria:

* Candidates for ambulatory total knee arthroplasty
* Candidates for ambulatory total hip arthroplasty
* Candidates for ambulatory revision knee arthroplasty (liner exchange only)
* Candidates for ambulatory revision hip arthroplasty (liner exchange only)
* Case scheduled before noon (12 pm)
* Patient agrees to same-day discharge and has a responsible adult to spend the night on the day of discharge

Exclusion Criteria:

* BMI less than 18.5 or greater than 37.0
* Patients with diabetes, chronic kidney disease, clotting disorders, or neurological conditions preventing control of the affected limb.
* Pregnant women
* Patients scheduled as ambulatory due to insurance mandates
* Patients with a history of active ischemia, significant valvular disease, significant arrhythmias, obstructive sleep apnea as per Hospital for Special Surgery guidelines, chronic opioid dependence (chronic daily opioid use for six or more months), and glomerular filtration rate \< 60ml/min.
Epidemiologic Features of Kawasaki Disease in Shanghai From 2008 Through 2012

To investigate the epidemiological pictures of Kawasaki disease (KD) in Shanghai from 2008 through 2012, and illustrate the risk factors of coronary arterial lesions .

A questionnaire form and diagnostic guidelines for KD will be sent to 50 hospitals providing pediatric medical care in Shanghai, China. All patients with KD diagnosed during January 2008 through December 2012 will be recruited and analyzed. Distribution of age at onset and seasonal features of disease incidence wil be described. Univariate and multivariate association analyses will be performed to identify risk factors to Coronary arterial lesions (CAL) defined as ectasia or aneurysm by using multivariate logistic regression model.

Eligibility Criteria:
Inclusion Criteria:

* The 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002, was adopted. Cases were included in the study if the patients had at least five of the following six clinical manifestations or at least four signs together with coronary abnormalities documented by echocardiography or coronary angiography:

  1. fever persisting 5 days or longer (inclusive of those cases in whom the fever has subsided before the 5th day in response to therapy)
  2. bilateral conjunctival congestion
  3. changes of lips and oral cavity, such as reddening of lips, strawberry tongue, diffuse congestion of oral and pharyngeal mucosa
  4. polymorphous exanthema
  5. changes of peripheral extremities, such as reddening of palms and soles, indurative edema at initial stage, or membranous desquamation from fingertips at convalescent stage
  6. acute nonpurulent cervical lymphadenopathy. In addition, the cases of incomplete KD, diagnosed with referring to the guidelines for incomplete KD made by American Academy of Pediatrics (AAP) and American Heart Association (AHA) in 2004, were also included in this investigation

     Exclusion Criteria:
* The cases were not in accordance with the recruited criteria
Screen Free Time With Friends: a Cluster-randomized Controlled Trial

The Screen Free Time with Friends study is a cluster-randomized controlled trial aiming to promote more time face-to-face with friends and reduce recreational screen media use after school and during weekends among children aged 9-11 years. The primary aim is to investigate the between group difference in change in children's time spend face-to-face with peers. Secondary aims are to investigate the between group difference in change in children's screen media use, physical activity, wellbeing, social relations, smartphone addiction, sleep and parents smartphone use and risk of smartphone addiction.

During the past fifteen years, children's leisure time spent interacting with friends in person has decreased, while the time they spend engaging with digital screens has increased. These changes in behavior can potentially have adverse effects on both their physical and mental wellbeing.

This cluster-randomized controlled trial aims to evaluate an intervention aiming to increase face-to-face interaction with peers and reduce screen media use in 3rd - 4th grade-children. The study is built upon experiences gained from a recently conducted non-randomized single group feasibility trial. The feasibility trial aimed to 1) examine the feasibility of the intervention 2) examine participant recruitment and retention rates, 3) examine the feasibility of the data collection plan and completeness of the compliance and outcome assessment, and 4) obtain baseline and follow-up data on the planned full trial primary outcome.

To recruit schools and afterschool clubs for the RCT, schools will be contacted directly by a member of the research team or via the municipality. Schools and their belonging afterschool clubs are eligible if they meet the following criteria:

1. the school must have an afterschool or youth club (or similar) within walking distance,
2. the afterschool club's leader and staff must be willing to develop the club by participating in a training course.

After the baseline measurements the schools and afterschool clubs will be randomized into an intervention and control group. The Screen Free Time with Friends intervention is targeted children in 3rd to 4th grade and their families, school- and afterschool club staff, as well as stakeholders in the local community. It comprises an initial gathering for all stakeholders, family workshops held at the school, an exercise during a parent-school meeting, lectures conducted during school hours, a training program for afterschool club staff, and workshops involving local stakeholders.

A process evaluation will be conducted to monitor the implementation of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* the school must have an afterschool or youth club (or similar) within walking distance
* the afterschool club's leader and staff must be willing to develop the club by participating in a training course.

Exclusion Criteria:

* no exclusion criteria
Extension to Study HMR1964A/3011 in Belgium

The purpose of this trial is to allow patients to continue on HOE 901 until launch and to gather additional long-term safety data.


Eligibility Criteria:
Inclusion Criteria:

* Subjects treated with HOE901 and who, in the judgement of the investigator, have benefited from the use of HOE 901 in a previous clinical study with HOE 901.
* Subjects treated with HOE 901 in a previous clinical study with HOE 901 for whom a change of basal insulin would destabilise glucose metabolism.
* Subjects who are likely to comply with the investigator's instructions.

Exclusion Criteria:

* Evidence of an uncooperative attitude.
* Subject not on adequate contraception, or who is pregnant, or breast feeding.
* Subject unable to understand informed consent.
* Patient receiving or likely to receive HOE901 treatment outside of SPC or PI recommendations.
* Subject becomes pregnant or is planning to become pregnant.
Avera Cancer Sequencing and Analytics Protocol (ASAP)

The purpose of this study is to understand the breadth of molecular characteristics present in participants cared for in a large integrated, community-based health care system. Using comprehensive genomic profiling and proteomics, the investigators seek to identify the underlying genomic drivers of premalignant or malignant conditions in participants across different stages of disease development and cancer types.

Comprehensive molecular profiling will consist of somatic tumor testing (tissue and/or blood) using whole exome sequencing, whole transcriptome sequencing, proteomics, and selected instances of whole genome sequencing. In addition, the investigators seek to perform broad hereditary cancer testing in affected participant populations. Hereditary testing has implications in screening, prognosis, and therapeutics for affected participants, as well as broad implications for genetic counseling and cascade testing.

In order to maximize the value of genomic information, participants consented to this protocol will have their electronic health records (both retrospectively and prospectively) abstracted, curated, annotated and linked to genomic information obtained though the testing performed. Given the long-term value of this data, participants will also be asked to voluntarily consent to have their samples stored in a biobank and have their de-identified information used for future research.

Information collected across this participant population will aid in advancing the investigators' knowledge of cancer biology, to discover and validate biomarkers associated with clinical outcomes, and shared in collaborative projects in order to promote the study of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Must be undergoing a workup or being followed for a premalignant condition or have a diagnosis of cancer
* Must voluntarily sign and understand the most current IRB-approved consent form prior to study participation

Exclusion Criteria:

* Participants incapable of understanding the items listed in the consent form and process
* Participants with a history of or known psychiatric illness deemed unable to consent or adhere to study requirements
Duke Transplant University

The purpose of this research study is to determine the effectiveness of educational videos for patients who have just had kidney transplant compared to usual patient education practices. Eligible patients will have the opportunity to enroll in this study after their transplant procedure either before hospital discharge or at their first follow up clinic visit.

Participants will then complete a demographic survey and knowledge assesment to establish their baseline of knowledge regarding post-transplant care, medication adherence and patient satisfaction. Participants will then be randomly selected to receive either the usual patient education care provided for patients following kidney transplant, or to receive the usual care plus access to educational videos designed especially for post- transplant patients. Videos can be viewed on a tablet computer with their transplant team during clinic visits and at home using a smartphone.

At 3 months post-transplant, all participants will be asked to repeat the knowledge assessment. Hospital re-admissions and patient satisfaction will be measured at 6 months after transplant.

Eligibility Criteria:
Inclusion Criteria:

* recent kidney transplant recipients
* competent with the capacity to give legal written consent

Exclusion Criteria:

* Unable to sign informed consent.
* Patients with delirium, dementia, or other cognitive impairment that would not allow informed consent to enter the study.
* patients with severe vision or auditory impairment who are unable to view or hear electronic videos at close range.
* patients who are unable to understand the English language.
Hyponatremia Due to Poly Ethylene Glycol (PEG)

Colonoscopy is a useful tool used in modern medicine and it is increasingly being employed for both diagnostic and therapeutic purposes. (Polyethelene glycol)PEG is very often used for bowel preparation.There are some cases of hyponatremia reported due to the use of PEG. This study was designed to find frequency of sodium disorders after bowel cleansing by Polyethylene glycol solution for colonoscopies in Dr. Ruth K.M. Pfau, Civil Hospital Karachi.

Colonoscopy is a useful tool used in modern medicine and it is increasingly being employed for both diagnostic and therapeutic purposes. PEG is very often used for bowel preparation. PEG solutions clean the bowel with less water and electrolyte shifts, primarily by causing mechanical effect of large-volume lavage 1. However, there are some cases of hyponatremia reported due to the use of PEG. Life-threatening fluid and electrolyte disturbances are more likely to occur in patients with risk factors, such as old age, use of SSRIs and thiazide diuretics, chronic kidney disease, congestive heart failure or with a history of electrolyte abnormalities 2.

Although sporadic case reports of hyponatremia and other electrolyte imbalances after bowel preparation have been reported, but well-designed studies are lacking on this subject. Literature search did not reveal any local studies on this subject. This study was designed to find frequency of sodium disorders after bowel cleansing by Polyethylene glycol solution for colonoscopies in Dr. Ruth K.M. Pfau, Civil Hospital Karachi.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of either gender of age between 18-80 years undergoing colonoscopy.
2. Patients should have normal electrolytes before taking solution.
3. Patients should have given informed consent.
4. Patients should have taken solution adequately before procedure.

Exclusion Criteria:

1. Patients with chronic kidney disease
2. Patients on diuretics
3. Patients who are hyponatremic on first sample, i.e., before taking bowel cleansing agent.
4. Hypothyroidism

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Satisfaction of Patients With the Chosen Method of Inhibition of Lactation

The aim of the study is to improve the standard of care in case of the inhibition of lactation.

The participant qualified for the study will answer the questions contained in the survey. The patient will have her breast palpated and then will be instructed on the possible options for the inhibition of lactation. The participant, who decides to inhibit lactation with medications, will be consulted by a doctor.

Each patient will receive information of the possible ways to relieve the symptoms of overfilled breast and be able to contact with lactation consultant. The participant will also receive a card to assess the severity of symptoms in the following days. The investigators will call the patient between the third and fifth day by phone.

Once again, after 2 weeks from the beginning of the inhibition of lactation in order to ask questions contained in the survey (the course of the process, problems that occurred and the level of satisfaction with the chosen method).


Eligibility Criteria:
Inclusion Criteria:

* Mother during the period of six weeks after childbirth
* Decision to inhibit lactation
* Patient's age at the time of enrollment (at least 18 years old)

Exclusion Criteria:

* Less than 18 years of age
* Lack of patient's consent
* To the pharmacotherapy group- contraindications for the use of the medication
Cleft Palate With Intravelar Veloplasty Repair

Cleft palate repair is the most important component of cleft surgery, not only in that it determines the outcome as far as speech and communication are concerned, but also in that it potentially has the greatest impact on maxillary growth and the dental arch relationship. Sommerlad technique has been described as a more physiological approach, aiming to restore the anatomy of the velum. This technique, often described as radical intravelar veloplasty, has the following distinctive components: a radical retroposition of velar musculature (m. levator veli palatini, m. palatoglossus, and m. palatopharyngeus), combined with minimal dissection of the hard palate, a tensor tenotomy, and the repair of the m. levator sling


Eligibility Criteria:
Inclusion Criteria:

* Patients with isolated cleft palate age from 9 months to 18 years.
* Patients with submucous cleft.
* Velopharyngeal incompetence (VPI) for palatal re-repair.

Exclusion Criteria:

* Medically unfit patients.
* Syndromic patients with cleft lip and palate.
* Patients with cleft palate associated with multiple congenital anomalies.
* Patients with neurological disorders.
Fluid Responsiveness Evaluation in Patients With Acute Circulatory Failure and Arrhythmia With Atrial Fibrillation: Indice Delta ITV / Delta RR

Fluid therapy is often used as first line treatment of acute circulatory failure, aiming an increase in cardiac output (by improving preload) and in tissue perfusion. Depending on left ventricular systolic function, fluid challenge could lead to an increase in cardiac ouput and tissue perfusion, or only detrimental consequences (by fluid overload and aggravation of lung and tissues oedema, increase of morbi-mortality). Patients are defined as responders to fluid therapy if one can observe an increase of cardiac output up to 15% after fluid therapy (500ml of crystalloids): gold standard test used in most of the studies on the subject. Literature reports on heterogenous populations a reproductible and constant response rate to this fluid challenge of 50%. It seems reasonable to dispose of indices allowing to predict fluid responsiveness without resulting in fluid intake. Statics markers have been abandonned for several years and dynamics methods have been developped.

In front of arrythmia, validated methods are scarce. Passive leg rising method appears to be the only one and it's validity seems to be less well documented than in sinusal patients. The purpose of this study is to determine a new method to assess fluid responsiveness in arrythmic patients.

In atrial fibrillation, RR interval varies widely between cardiac cylces. Systolic interval remain constant. Variations will occure at expense of diastolic interval, or ventricular filling interval. One can reliably assume that when RR is longer, preload is rising. If the patient is on the ascendant part of the Franck-Starling curve, a longer RR should cause au greater VTI (Vitess Time Integral, surrogate of cardiac output).

The evaluation by transthoracic echocardiography of the indice delta ITV / delta RR should determine the degree of fluid responsiveness in arrhythmic patients.

After decision of fluid expansion, patients will have haemodynamic and echocardiographic data measured, delta ITV / delta RR indice assessed, then passive leg rising and fluid expansion with 500 ml of cristalloids administered, with evaluation of VTI (as surrogate of cardiac output) at each time. Fluid responders will be compared to non-responders to evaluate the diagnostic performances of the indice delta ITV / delta RR.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients in the units of Surgical ICU and Cardiothoracic ICU of the Universatory Hospital of Poitiers
* With atrial Fibrillation
* With spontaneous ventilation
* With acute circulatory failure and medical decision to fluid therapy (Systolic Arterial Blood Pressure \< 90 mmHg and/or vasopressors agents)
* With no left or right ventricular dysfunction

Exclusion Criteria:

* Patients \< 18 yrs
* Contraindictions to passive leg rising
* Clinical evidence of hemorrhagic shock
* Cardiogenic shock
* Necessity of fluid expansion in emergency
* No echographic windows
A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.

This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV);
* eligible to start treatment with Tarceva, or receiving Tarceva for \<=5 days.

Exclusion Criteria:

* presence of skin rash or other signs of skin toxicity;
* treatment with any systemic or intranasal antibiotic within 7 days before randomization;
* treatment with other topical formulation within 14 days before randomization;
* other anticancer therapy in addition to Tarceva.