cyrilzakka/clinical-trials huggingface dataset:
Prioritising Patient Medication Review: Hospitals Reaching Out

To examine the effect of a cross-sectoral medication review intervention to admitted multi-morbid, polypharmacy patients aged 65+ at SHS in two settings; an acute admission unit (typical admission time \< 48 hours) and a medical outpatient setting (patients routinely visits for follow-up, diagnosis or treatment, but do require a bed or overnight care).

Lack of medication treatment coordination among especially multi-morbid patient's results in suboptimal medication treatment, adverse effects, increased use of resources, hospital admissions and premature death. Further, an aging population is a challenge to healthcare systems worldwide as older adults are vulnerable to non-communicable diseases and multi-morbidity. The age distribution varies across Denmark creating demographic inequality with a higher proportion of elderly in several municipalities in Southern Jutland and on a national level, the population aged 70+ already accounts for more than a third of all hospital days.

As the population ages, the concept of frailty becomes increasing in the provision of health care to an ageing population, and the Clinical Frailty Scale (CFS) can be used as a judgement-based frailty tool to evaluate specific domains including comorbidity, function, and cognition to generate a frailty score. In addition, an attempt to detect patients at high risk of medication errors is the Medicine Risk Score (MERIS) where acutely admitted patients are allocated into low and high risk of potential ADEs by predefined detection limits. Further, These components will be used to determine

In addition, an understudied patient group within polypharmacy and PIPs, are patients with dementia creating inequality among patient groups. The use of polypharmacy and Potential Inappropriate Prescribing are widespread in this patient group, and dementia is well-known to have a negative effect on overall mortality, which demonstrates the need for interventions to improve medication treatment in people with dementia. Intervention studies have examined the effects of pharmacist-led medication reviews in different hospital settings with various outcomes, but no exact model for prioritising patient medication review exists. Thus, there is a need to identify patients who will benefit most from a medication review in terms of outcomes, such as readmission, emergency department and general practitioner contacts. The aim of this project is to examine the effect of a cross-sectoral medication review between a clinical pharmacist and a medical specialist in coordination with the General Practitioner (GP), including patients from Hospital Sønderjylland, University Hospital of Southern Denmark (SHS).

Eligibility Criteria:
Inclusion Criteria:

* all hospitalized patients who are prescribed at least seven medications specified in the Electronic Patient Journal (EPJ) at admission

Exclusion Criteria:

* terminal patients or patients with a short life expectancy, patients residing in another region, patients who are discharged on the day of inclusion, and finally patients who do not speak Danish.
Predictors of Failed Thrombolysis in Acute Myocardial Infarction

The purpose of this observational study is to assess why thrombolytic treatment with tissue-plasminogen activator (t-PA) fails in patients with acute ST-segment elevation myocardial infarction (STEMI). The study will include 200 STEMI patients at the time of arrival at Oslo University Hospital Ullevål after receiving prehospital thrombolysis. A blood sample will be taken immediately for the study of factors related to coagulation, fibrinolysis and inflammation. Levels of the biomarkers will be compared between patients with successful and failed thrombolysis.

This study aims to explore why thrombolytic treatment with tissue-plasminogen activator (t-PA) fails in up to 50 % of pasients with acute ST-segment elevation myocardial infarction (STEMI). This is important in Norway due to the long geographic distances and the fact that up to 70 % of STEMI patients in some Norwegian areas receive thrombolysis in stead of primary, invasive revascularization with percutaneous coronary intervention (PCI). Today, no well-defined biomarker or score can predict the successfulness of thrombolytic therapy during STEMI. As failed thrombolysis leads to larger myocardial infarctions and poorer outcome, defining factors for improved risk stratification is important.

The TROFAMI study is a prospective study which will include 200 STEMI patients given prehospital thrombolysis. A blood sample will be taken immediately after hospital admission for the analysis of potential relevant biomarkers related to coagulation, fibrinolysis and inflammation. The biomarkers will be evaluated against the successfullness or not of thrombolysis.

Oslo University Hospital is the largest STEMI center in Norway. Each year, approximately 100 STEMI patients given prehospital thrombolysis are hospitalized at Ullevål. The inclusion is anticipated to take place during the time period 2022-2024.

Eligibility Criteria:
Inclusion Criteria:

STEMI patients \> 18 years given prehospital thrombolysis.

Exclusion Criteria:

None.
The Efficacy and Safety of Using the Novel Tyto Device

To investigate the efficacy and safety of using the novel Tyto device for remote physical examination by co-investigators as compared to a standard medical physical examination by physicians.

A single center, prospective, qualitative study. Patients referred to the emergency department will be triaged according to The Canadian Triage \& Acuity Scale (CTAS).

Patients presenting with complaints suitable for examination with the Tyto device (ear/throat/respiratory/cardiac complaints) and meeting the inclusion criteria will be informed and asked for consent. Patients participating in the study will be referred to a room dedicated for the purpose.

A minimum of a hundred volunteer patients will be selected and enrolled for a preliminary Pilot Study. Final study design and its extent will be determined accordingly.

Physical examinations using the Tyto device will be performed by the co-investigators, and sent online to the principle investigator for remote analysis.

The emergency department physician will examine the patient using conventional examination instruments (i.e. stethoscope, otoscope).

The data collected will be recorded on predetermined case report form (CRF), timed, stored and analyzed by the principle and co-investigators. The findings of the co-investigators' examination will be compared to the conventional examination instruments used by the emergency department physician.

Results will be checked and compared categorically (0-inconclusive; 1-normal; 2-pathological findings)

Eligibility Criteria:
Inclusion Criteria:

* Patients who present to the Emergency department and are categorized between 2-5 on the Canadian Triage \& Acuity Scale (CTAS) scoring scale.

Exclusion Criteria:

* CTAS 1.
* Pregnant adolescent.
* Multi-drug resistant carriers.
* Intellectual disability disorders.
* Unsigned informed consent.

  * Patients with CTAS score of 2-3, will be first addressed by a physician to ascertain their eligibility to be enrolled to the study.
Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS)

The Collaborative Italian-American Clinical Trial of Nutritional Supplements and Age-related Cataract (CTNS) is a 13-year study designed primarily to evaluate the safety and efficacy of a vitamin-mineral supplement (Centrum) containing recommended daily-allowance dosage (RDA) in preventing age-related cataract or delaying its progression in participants with early or no cataract at baseline.

Despite dramatic increase in the rates of cataract surgery during the last decades, age-related cataract is still responsible for about 50% of cases of severe visual impairment in developing countries, and for high and growing health care costs in western countries. CTNS was designed to complement the U.S. Age-Related Eye Disease Study (AREDS) by evaluating a much broader spectrum of nutrients at RDA dosages. Whereas about 60% of the AREDS control group was taking RDA dose multivitamin supplements, none of the participants in CTNS had taken any type of nutritional supplement for at least one year before the qualification visit. Therefore, the CTNS will be able to evaluate the effect of RDA doses versus no supplementation at all. CTNS and AREDS will use similar procedures, including those for grading the presence and severity of lens changes.

CTNS is a randomized,parallel group, placebo controlled, double blinded, single center, intervention trial.

Primary Outcomes: photographic evaluation of a prespecified increase from baseline in nuclear, cortical, or posterior subcapsular cataract (PSC) opacity grades or cataract surgery.

Secondary Outcomes: increase in type-specific opacity grade, cataract surgery, and visual acuity loss from baseline \> or = 15 letters.

Patients will be followed for a maximum of 10 years.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and photographic diagnosis of early or no age-related cataract
* Participants with early cataract must have at least one eligible eye with VA score 20/32 or better
* Participants with no cataract must have VA score 20/32 or better in both eyes.

Exclusion Criteria:

* Advanced cataract
* Bilateral aphakia or pseudophakia
* Any ocular disease or condition that might complicate the future evaluation of cataract
* Regular use of nutritional supplements
* Failure to take at least 75% of run-in medication
* Cancer with evidence of recurrence in the past 5 years
* Major cerebral or cardiovascular events in past 12 months
* Current participation to other clinical trials
* Any condition likely to prevent adherence to CTNS follow-up schedule
Gene Editing as a Therapeutic Approach for Rett Syndrome

We designed the project to validate CRISPR/Cas9-based gene editing combined with AAV-based delivery for correction of the most common MECP2 mutations both in vitro and in vivo.

The project aims to validate CRISPR/Cas9-based gene editing combined with AAV-based delivery for correction of the most common MECP2 mutations both in vitro and in vivo. The laboratory of the principal investigator is an active member of the European Reference Network for rare malformation syndromes and rare intellectual and neurodevelopmental disorders (ERN-ITHACA).

Eligibility Criteria:
Inclusion Criteria:

* Patients -exclusively female- since the pathology is linked to the X chromosome, with a clinical diagnosis of Rett syndrome confirmed at the genetic level by the identification, through NGS analysis, for one of the recurrent mutations (mutational hotspots) in the MECP2 gene object of the study:

  c. 473C\>T - (p.(T158M)), c.502C\>T (p(R168X)), c.763C\>T (p.(R255X)), c.916C\>T (p.(R306C));
* Age above 6 months;
* Availability of parents or legal guardians to provide free and informed consent to participate in the study

Exclusion Criteria:

* NGS diagnosis with the normal outcome;
* Positive NGS diagnosis for mutation in MECP2 but with the presence of a mutation different from those under study.
* Unwillingness of parents or legal guardians to provide free and informed consent to participate in the study;
A Study to Evaluate the Efficacy and Safety of AD-224

The purpose of this study is to evaluate the efficacy and safety of AD-224

Condition or disease : Essential Hypertension

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Patients with Essential Hypertension
* Other inclusions applied

Exclusion Criteria:

* Patient with Secondary Hypertension
* Other exclusions applied
GH and Cardiovascular Risk Factors

Rationale: Abnormally low and high levels of insulin-like growth factor-I (IGF-I) are both associated with increased metabolic risk. Since (U-shaped) associations of IGF-I, within the normal range, have also been found with cardiovascular risk factors and disease in the general population, it would be interesting to investigate if this association can also be found in growth hormone deficient (GHD) adults treated with Growth Hormone (GH). This could be of interest for endocrinologists prescribing GH in clinical practice because strict dosing may become even more important. Next to that, scientific evidence for clinical practice is wanted.

Objective: Next to cardiovascular risk factors (main objectives: body composition and lipid profile; secondary objectives: remainder) we investigate the effect on glucose metabolism, physical performance, and neuropsychological functioning of different levels of IGF-I in GH treated GHD men and women.

Study design: Open-label randomized trial.

Study population: At least 32 subjects, both childhood as adult onset GHD men and women, receiving GH treatment for at least one year, with an age between 20 and 65 years.

Intervention: At entry subjects are already receiving GH treatment according to general clinical practice, and are expected to demonstrate an IGF-I concentration of 0 - 1 SD score (SDS) (normal dose). The group of men and group of women will be randomized to receive either a decrease of their regular dose of GH treatment (IGF-I target level of -2 - -1 SDS) (low dose), or an increase of their regular dose, (IGF-I target level of 1 - 2 SDS) (high dose) for at least 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Ongoing surveillance at our centre (VUmc)
* Stable substitution therapy for other pituitary hormone deficiencies

Exclusion Criteria:

* Subjects with a craniopharyngioma as cause of their GHD or pituitary deficiencies
* Contraindications for the use of GH treatment
* (Receiving treatment for) malignant disease (in the past)
* Cardiovascular event less than one year prior to inclusion
* Participation in other studies
* Subjects, who in the opinion of the investigator, are unsuitable in any other way to participate in this study
A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3)

This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.


Eligibility Criteria:
Inclusion Criteria:

* adults, \>/=18 years of age
* metastatic melanoma, stage IIIC or IV (AJCC)
* treatment-naïve (no prior systemic anticancer therapy)
* positive for BRAF V600E mutation
* measurable disease by RECIST criteria
* negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion

Exclusion Criteria:

* active central nervous system metastases
* history of carcinomatous meningitis
* severe cardiovascular disease within 6 months prior to study drug administration
* previous malignancy within 5 years prior to study, except for basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix
A Study of Mycophenolate Mofetil (CellCept) in Lung Transplant Recipients

This open-label, single center study will assess the pharmacokinetics, efficacy and safety of mycophenolate mofetil in lung allograft recipients. Participants will be split into 2 groups according to the original disease: Group A (cystic fibrosis) and Group B (chronic obstructive pulmonary disease \[COPD\], emphysema, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency \[A1AD\]). All participants will receive mycophenolate mofetil orally, 1.5 grams (g) twice daily (BID) from Day 2 to 30 post transplantation, and 1 g BID from Day 31 to 90 post transplantation. Anticipated time on study treatment is 90 days, and target sample size is 50-100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* primary single or bilateral lung allograft
* original disease cystic fibrosis, COPD, emphysema, idiopathic pulmonary fibrosis or A1AD

Exclusion Criteria:

* lung allograft retransplantation
* multiple organ transplantation
* severe gastrointestinal disorder
* malignancies or history of malignancy
Serum Procalcitonin Study in the Management of Ventilated Patients

The purpose of this study is to test a new method for diagnosing and monitoring Ventilator-Associated Pneumonia, which is a major killer among ICU patients. The method requires analysis of a small amount of the patient's blood for concentration of a hormone called Procalcitonin.

Ventilator-associated pneumonia is a leading cause of mortality in critically ill patients. The purpose of this study is to evaluate the relationship between the onset/progress/resolution of pneumonia and the levels of Procalcitonin, a prohormone whose concentrations fluctuate in response to bacterial infection.

Eligibility Criteria:
Inclusion Criteria:

* Are willing to give or who's proxy is willing to consent to be a study subject
* Are at least 18 years of age;
* Who are mechanically ventilated surgical intensive care unit patients.

Exclusion Criteria:

* Participation in any investigational device or drug trial within 30 days prior to enrollment.
Study of an Internet-delivered Treatment Based on Experiential Dynamic Psychotherapy for Social Anxiety Disorder

The aim of this randomized, controlled study is to examine an internet delivered, self-help program for social anxiety based on psychodynamic therapy. The study will compare three conditions: the psychodynamic program with therapist support, without therapist support and a waitlist control.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Fulfill the DSM-5 criteria for social anxiety disorder (Score \> 60 on the self-assessment instrument LSAS-SR)
* Have access to a computer/smartphone/tablet with internet connection
* Be able to read and write Swedish.

Exclusion Criteria:

* Suicidal (within the previous month, assessed with the self-assessment instrument C-SSRS)
* Partaking in psychological treatment
* Ongoing treatment with psychopharmacological drugs with dose adjustments within the nearest month or planned dose adjustments.

The following self-reported diagnoses are excluded:

* Autism spectrum disorder
* Serious depression (Score ≥ 20 on the PHQ9)
* Indications of psychosis or bipolar disorder (type 1 or 2).
Pilot Study of Strength Testing in Overweight Women With or Without Insulin Resistance

Background:

- Some people who are obese may have decreased muscle strength. They may have greater muscle mass shown in scans, but they show poor results in exercise tests. Poor muscle strength might cause some of the difficulty with exercise performance. Researchers want to test muscle strength in the arms and legs of overweight women. They will also see how insulin resistance affects muscle strength in these women.

Objectives:

* To test muscle strength in overweight women.
* To see if insulin resistance affects muscle strength.

Eligibility:

- Women at least 18 years of age who are overweight (body mass index greater than 25 kg/m2).

Design:

* Participants will be asked to fast before having an initial blood test to measure glucose and insulin levels.
* On a different day, they will have the strength testing. The first test will measure leg muscle strength by testing the quadriceps and the hamstrings. The second test will measure arm muscle strength by testing the biceps and triceps. The final test will measure hand muscle (grip) strength.
* All the tests should take about an hour.

We have observed in our protocol (08-H-0108: Effects of Worksite Wellness Interventions on Vascular Function, Insulin Sensitivity and High-Density Lipoprotein in Overweight or Obese Women) that despite increased lean (muscle) mass in the extremities as measured by dual x-ray absorptiometry, obese women have poorer exercise tolerance than overweight women who have less muscle mass.1 Exercise testing, however, is an integrated function of cardiopulmonary capacity, in addition to muscle strength and endurance. We propose to determine whether muscle strength of elbow flexors and knee extensor muscle groups correlates with muscle mass of these groups in overweight and obese women selected for normal or abnormal insulin sensitivity. Our hypothesis is that subjects with impaired insulin sensitivity and high insulin levels will have greater muscle mass but lower muscle strength than subjects with normal insulin sensitivity and normal insulin levels. This is a feasibility study to be conducted in 10 non-diabetic women (5 with insulin resistance, 5 with normal insulin sensitivity) who previously participated in 08-H-0108, the outcome of which will provide data for planning a larger study of muscle mass and strength which may be important to achieving exercise goals important to successful weight loss.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Non-diabetic female employees of NIH who participated in protocol 08-H-0108 and underwent insulin sensitivity testing and also protocol 02-H-0050 for muscle mass determination.
* BP\< 140/90 mmHg (medications allowed)
* Subject understands protocol and provides written, informed consent.

EXCLUSION CRITERIA:

* Medical or surgical condition that would prohibit upper and lower extremity strength testing (e.g., painful arthritis, prior knee or elbow surgery)
* Infection or injury to hand, knee or elbow requiring medical attention within 3 months of testing