cyrilzakka/clinical-trials huggingface dataset:
Lucerne Fall Risk Prediction Score for Stroke Rehabilitation

In Switzerland, every year around 16'000 people suffer a stroke. Stroke represents the third most common cause of death in Switzerland and leads to impairments (e.g., motoric, cognitive, sensory) resulting in disability. People with disabilities after stroke should have access to specialised interprofessional rehabilitation settings.

During inpatient rehabilitation, 15-36% of the patients experience one or more falls. It is well known that stroke is an important risk factor for falls. On average stroke patients fall 1.77 times more than the age- and gender-matched controls over 13 months. Falling events during inpatient stroke rehabilitation result in an extension of rehabilitation stay of about eleven days. Wong et al. (2016) suspect that a reduction in the activity level due to falls, fear of falling again as well as changes in discharge conditions could be the reason for this extended length of stay. Walsh et al. (2018) demonstrate that patients who fall once within the first year after stroke cause € 8'600 and recurrent fallers € 12'700 higher healthcare costs.

Fall risk factors after stroke are well investigated. Campbell \& Matthews (2010) have collected multiple factors for falls in inpatient stroke rehabilitation from 1990 to 2009 in an integrative review. A newer systematic review points out physical function, hemi-attention, and stability as the most important factors for falls in inpatient stroke rehabilitation. However, none of the included studies showed a validated prediction model with acceptable performance. Hence, further investigations regarding the impact of various valid and reliable fall risk assessments at admission in inpatient rehabilitation are needed.

The neurorehabilitation team of LUKS systematically assesses the patient's functions and activity to design patient-specific, evidence-based rehabilitation. Therefore, a population-specific fall risk model based on standardized assessments performed in the clinical routine would help to identify patients with a high risk of falling during rehabilitation without the need of implementing an existing model with a low performance.

Aim of the study The main aim of this study is to establish a multivariable prediction model for falls during inpatient rehabilitation in acute and subacute stroke patients admitted to the Clinic for Neurology and Neurorehabilitation of the Kantonsspital Luzern (LUKS) in Lucerne, Switzerland.

The secondary aim is to explore the value of the mini-BESTest as a fall predictor in a subgroup consisting of patients who are ambulatory at admission to the Clinic for Neurology and Neurorehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Acute/ subcute first or recurrent stroke
* Inpatient rehabilitation
* Signed general consent

Exclusion Criteria:

- Re-rehabilitation due to a chronic stroke
Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have mesothelioma of the lung.

OBJECTIVES:

* Determine the proportion of patients with potentially resectable mesothelioma of the pleura remaining operable after treatment with neoadjuvant cisplatin and gemcitabine.
* Determine the response rate and overall survival of patients treated with this regimen.
* Determine the tolerability of this regimen in these patients.
* Determine the number of postoperative hospitalization days and occurrence and duration of surgical complications in patients treated with this regimen.
* Determine the quality of life of patients treated with this regimen.
* Compare the proportion of patients who report psychological distress at 3 months after surgery vs at study registration.

OUTLINE: Patients receive cisplatin IV on day 1 and gemcitabine IV on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses. Within 6 weeks after completion of chemotherapy, patients undergo restaging by CT scan followed by surgical resection.

Quality of life is assessed at baseline, day 1 of course 3, within 4 weeks after surgery, and then at 3 and 6 months.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically and clinically confirmed pleural mesothelioma

  * Stages T1-3, N0-2, M0 by CT scan of the chest

    * Mediastinoscopy required for staging of mediastinal lymph nodes
  * Considered completely resectable

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* WHO 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* No severe liver disease

Renal:

* Creatinine no greater than 1.7 mg/dL

Cardiac:

* Adequate cardiac function
* No cardiac disease that would preclude forced hydration or surgery

Pulmonary:

* Predicted postoperative FEV_1 greater than 1 by spirometry

Other:

* No contraindication to surgery
* No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* No uncontrolled infection
* No uncontrolled diabetes
* No neurologic or psychiatric disorders that would preclude study compliance
* No other serious illnesses that would preclude study participation
* No other circumstances that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* No prior pleurectomy or lung resection except for diagnostic purposes
Evaluation of the BHX Implant in Children with a BAHS

The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of bone anchored hearing systems in the pediatric population.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have decided to undergo a Bone Anchored Hearing Surgery and receive a Ponto system.
2. Signed informed consent.
3. Patients between 5 - 16 years of age.
4. Patients eligible for one stage surgery.
5. Patients who have been using Ponto sound processor on a soft band for at least 2 weeks.

Exclusion Criteria:

1. Patients who cannot attend follow up visits.
2. Patients with single side deafness (SSD).
3. In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
4. Patients who receive other implant than the Ponto BHX.

   -
Semi-automatic Response System(SARS)in Type 2 Diabetes

Background

* Various kinds of interactive online communication systems have been introduced for long-term diabetes management, and their importance in managing patients is increasing. The investigators investigated the amount of physician time needed to maintain such a system, and the investigators developed software to maximise the cost effectiveness.

Methods

* The investigators conducted a prospective, randomised, controlled trial to investigate the efficacy and safety of a semi-automatic response system (SARS) for online glucose monitoring over a 24-week period of patients with type 2 diabetes. In the SARS group, the "SARS" software filtered the recorded self-monitoring of blood glucose data automatically to reduce the physicians' time, and the physicians managed patients regularly but only manually in the control (manual) group. The investigators measured the time spent by the physicians for online management and compared the HbA1c levels at enrolment and follow-up.


Eligibility Criteria:
Inclusion Criteria:

* men or women aged 20-70 years with type 2 diabetes
* lasting more than one year who had used the online communication system for diabetes management at the web site https://www.bi odang.com for more than six months
* baseline HbA1c level was 6-10%
* Patients who able and willing to complete glucose-monitoring diaries on a web chart as instructed.

Exclusion Criteria:

* patients who required intensive insulin therapy (multiple insulin injections or insulin pump therapy) or who were unwilling to use self-monitoring of blood glucose (SMBG)
* acute metabolic complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar non-ketotic hyperglycaemia, lactic acidosis)
* serum creatinine concentration \>2.0 mg/dl at screening
* active liver disease or ALT or AST activities \>2.5 times the upper limit of normal
* acute illness, chronic infection, heart failure of NYHA Class III or IV
* recent myocardial infarction or stroke during the past six months
* pregnancy or GDM, or any other factor likely to limit protocol compliance or reporting of adverse events
The Role of Timed Awakening in Treatment of Enuresis

The goal of this clinical trial is to evaluate the effectiveness of nightly timed awakening in the treatment of nocturnal enuresis in children aged 6-17. The main questions it aims to:

* Determine feasibility of nightly timed awakenings
* Determine the role, if any, of comorbidities on resolution of enuresis
* Determine incidence of daytime accidents
* Obtain patient and parental satisfaction scores

Researchers will compare a control group to treatment groups to see if there is any impact on nocturnal enuresis.

Participants will be woken up by parents in the middle of the night to use the restroom. In addition, participants will receive 30 minute psychotherapy sessions using telehealth.


Eligibility Criteria:
Inclusion Criteria:

* Our inclusion criteria are new and recently evaluated (within past 6 months) patients who are English-speaking
* aged 6-17
* referred to the urology clinic for enuresis (Enuresis in our study is defined as nocturnal or diurnal enuresis (more than 1 bedwetting episode/week) for greater than 3 months)

Exclusion Criteria:

* Diagnosis of enuresis with comorbid diagnosis of diabetes mellitus (type 1 and 2), diabetes insipidus, chronic kidney disease, polyuria and/or polydipsia
* Structural urologic disease (evaluated via baseline imaging)
* Diagnosis of neurodevelopmental delays or conditions (i.e. celebral palsy, autism spectrum disorder) that hinders inability to follow age-appropriate instructions
* Not potty trained
* Improved or resolved enuresis for patients recently evaluated (within the past 6 months)
* Non-English speaking
* Patients currently on any over-active-bladder (OAB) medications (b3- agonists, antichloingerics) or alpha blockers for urinary symptoms (i.e. alfuzosin, tamsulosion, etc) or anti-diurectic medications for urinary symptoms (i.e.: desmopression (DDAVP))
* Patients currently using bed-wetting alarms
* Patients and families who are actively seeing Pediatric Clinical Urologic Psychologist.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent or participate in the study
Analysis of Peripheral Blood ILC2s and Th2 Cells in Response to ANB020

This exploratory laboratory only study will assess alterations in immune cells in blood samples that may be responsive to an inflammatory mediator in asthma called IL-33 (Innate lymphoid type 2 cells, basophils and Th2 cells) in response to treatment with ANB020/placebo (a drug that targets IL-33, in the linked clinical trial ANB020-004). The study will involve additional 10ml blood draws on scheduled study visits in the ANB020-004 clinical trial at baseline, 1 week, 5 weeks, 18 weeks (4 visits total). Total number of subjects is 24 at the same 3 participating UK sites as the main linked clinical trial ANB020-004.

Blood samples will be sent on the same day to a flow cytometry laboratory at the NIHR Leicester Biomedical Research Centre (BRC) - Respiratory. A dedicated post doctoral, trained laboratory scientist will analyse the blood samples for the required cell types using a technique called flow cytometry - this technique identifies cell surface and intercellular markers, that together provide a unique cell identity. The experiments will be supervised by a senior research scientist and flow cytometrist Professor Dave Cousins, at the University of Leicester and results of the experiments will be fed back to AnaptysBio (the linked clinical trial Sponsor). Professor Salman Siddiqui at the University of Leicester will oversee the clinical conduct of this laboratory study and act as the Chief Investigator. Professor Siddiqui is also the local site lead Principal Investigator at Leicester for the linked ANB020-004 clinical trial described below.

The linked study (ANB020-004) is a Double-blind Placebo-Controlled Proof of Concept Study to Investigate ANB020 (a drug that targets an inflammatory mediator called IL-33) Activity in Adult Patients with Severe Eosinophilic Asthma. The expected duration of the study is up to 141 days. Screening period of 7-14 days and treatment and follow-up period of 127 days.


Eligibility Criteria:
Inclusion Criteria: Consenting participant in the ANB020-004 clinical trial (EudraCT 2017-000647-40) -

Exclusion Criteria:1) Unwilling to have four additional blood samples (10 mls per sample) for flow cytometry as part of the flow cytometry biomarker study linked to existing ANB020-004 study. (EudraCT 2017-000647-40)

-
Luteal vs Follicular Surgical Oophorectomy and Tamoxifen in Premenopausal Women With Metastatic Hormone Receptor Positive Breast Cancer

This study will determine if hormone receptor positive premenopausal metastatic breast cancer patients who undergo removal of the ovaries in mid-luteal versus mid-follicular phase have a longer survival.

Rationale: Previous research suggests that women who have their ovaries removed as part of their treatment for breast cancer may live longer if the ovarian surgery is performed during the luteal phase (last 14 days of the menstrual cycle) rather than the follicular phase (the first 14 days of the menstrual cycle). The current study will evaluate this important research question in premenopausal women with metastatic hormone receptor-positive breast cancer who will be treated with surgery and tamoxifen.

Purpose: The purpose of this research is to find out if premenopausal women with breast cancer that has spread to other parts of the body live longer if their ovaries are removed during the second half of the menstrual cycle. This study will compare how long women live if they have their ovaries removed during the first half of their menstrual cycle (follicular phase) to how long women live if they have their ovaries removed during the second half of their menstrual cycle (luteal phase). Tamoxifen will also be given to study participants.

Treatment: Study participants will have tests performed in advance of surgery to remove their ovaries. Surgery will be performed within four weeks of these tests. The exact day will be determined by the study participant's menstrual history and by a process called randomization, which is a random decision making process to determine if each study participant will have their surgery during the first or second half of their menstrual cycle. On the day of surgery, blood will be taken immediately prior to surgery and three hours after surgery for hormone tests. After the surgery, study participants will be given tamoxifen in oral pills for daily consumption. Study participants will be asked to return to the hospital every two months for tests and distribution of additional tamoxifen tablets. Treatments will be discontinued for disease progression or unacceptable adverse effects.

Eligibility Criteria:
Inclusion Criteria:

* Estrogen receptor or progesterone receptor positive breast cancer
* Premenopausal with regular menstrual cycles

Exclusion Criteria:

* Current oral contraceptives
Antidepressant Drug Exposure and Risk of Suicide Attempt Resulting in Medical Intervention in US Adults

The primary objective of the study is to estimate the incidence of suicide attempts resulting in a medical encounter or hospitalization in seven propensity matched cohorts of subjects: patients treated with duloxetine for depression, patients treated with one of three other antidepressants or antidepressant classes (venlafaxine, SSRIs, or TCAs) for depression, patients treated with multiple antidepressants for depression (either concurrently or consecutively), depressed patients with no pharmacologic treatment, and a non-depressed general population sample.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older at index date
* Have at least 6 months of continuous enrollment data prior to index date.
* Have complete medical, facility, and pharmacy records (the latter of which will include complete quantity and days supplied information).

Exclusion Criteria:

* None
Influence of Glitazones on the Vasodilatory Effect of High-density Lipoprotein (HDL) Lipoproteins

HDL from patients with type 2 diabetes show a significant reduction of their endothelium-dependent vasodilatory effect.

The primary objective of the study is to analyze whether treatment with glitazones (pioglitazone and rosiglitazone)may improve the endothelium-dependent vasodilatory effect of HDL lipoproteins in patients with type 2 diabetes.

The secondary objectives are:

* to analyze the effect of glitazone treatment on phospholipase A2
* to look for possible differences between the effects of pioglitazone and those of rosiglitazone
* to analyze the glycemic response to glitazone therapy according to clinical and biological baseline characteristics.

The study will be performed as follows:

At baseline, before initiating glitazone treatment, clinical data will be recorded and blood samples will be obtained for biological measurements (blood glucose, HbA1c, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, liver enzymes), phospholipase A2 measurement and the study of the vasodilatory effect of HDL particles.For this purpose, we will study,using rabbit aorta rings,the ability of HDL to suppress the inhibition of vasodilation that is induced by oxidised LDL.

For all the patients included into the study, a treatment by pioglitazone (at an initial dose of 30 mg/day) or rosiglitazone (at an initial dose of 4 mg/day) will be given by randomization.

A visit will be performed at week 12, in order to titrate the glitazone dose (up to 45 mg/day for pioglitazone, up to 8 mg/day for rosiglitazone)according to HbA1c level and values of self-monitoring blood glucose.

At week 24, the last visit will take place. During this visit, clinical data will be recorded and blood samples will be obtained for biological measurements (blood glucose, HbA1c, total cholesterol, triglycerides, LDL-cholesterol, HDL-cholesterol, liver enzymes), phospholipase A2 measurement and the study of the vasodilatory effect of HDL particles.

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes treated by oral antidiabetic agents (except glitazones) and/or insulin
* age\> 18 years
* HbA1c \> 6.5%

Exclusion Criteria:

* renal failure
* heart failure
* primary hyperlipidemia
* pregnancy
* treatment that may modify lipid metabolism (glucocorticoids, oestrogens, retinoids, HIV antiviral drugs)
Community Based Self Management of COPD Facilitated by a Palliative Care Team:Impact on Health Care Utilization and QOL

The purpose of this study is to compare in home support services for patients with COPD with usual care. The study is designed to evaluate the impact of an interdisciplinary palliative care team on community based self management of advanced COPD.

A total of thirty patients will be enrolled into this study. Twenty patients will be randomly assigned to receive usual care, and ten patients will be randomly assigned to usual care plus in home support services. This study will use objective criteria to identify patients with COPD likely to benefit from home based palliative care services. The patients will undergo initial assessment by medical, social work, and spiritual care personnel followed by a family meeting to establish a care plan. Periodic scheduled visits, and as needed unscheduled visits to address urgent needs will occur over one year's time in an attempt to return patients with COPD to the center of decision making regarding their care, avoid acute exacerbations and thereby avoid unscheduled clinic and ER visits. Patients will complete the QOL survey and symptom assessment scale upon initial intervention. After obtaining information from all patients who qualify for the study, participants will be randomized into cohorts. Those who are randomized to serve as cases will be provided with community based self management services by an interdisciplinary palliative care team. The control group will receive standard care. At the conclusion of 12 months both cases and controls will again complete the QOL survey,medical utilization, and symptom assessment.


Eligibility Criteria:
Inclusion Criteria:

* Age 60 or greater
* Dx of COPD
* Received 2 or more unscheduled acute care visits during the 12 months from Jan 2007-Dec 2007
* SMDC primary care provider
* Lives within 50 miles of Duluth Minnesota
* Informed consent

Exclusion Criteria:

* Non English speaking
* Too ill or cognitively impaired to provide baseline data or informed consent
* Lives more than 50 miles from Duluth
* Nursing home resident
Interactive Training in Sports Concussion Prevention and Management

This study evaluated Brain 101: The Concussion Play book, an intervention that provides education and resources on concussion management for high schools. The study hypotheses were that athletes and parents who viewed the Brain 101 program would demonstrate increased knowledge and self efficacy in concussion management, and that use of the intervention would positively affect school concussion management practices.


Eligibility Criteria:
Inclusion Criteria for participating schools:

* athletic trainer (AT) on staff or contracted by school for services
* school access to a high-speed internet connection
* agreement to expose all students participating in fall sports to the training.

Exclusion Criteria:

* didn't meet inclusion criteria
'Improving Urinary Tract Infection Diagnosis in Older Patients: Validation of a Biomarker Panel (UTI-GOLD)'

The goal of this study is to improve the diagnosis of urinary tract infections (UTI) in older people (≥65 years). The main research questions are:

Research questions

* What is the optimal cut-off for each individual biomarker NGAL,IL-6,AZU,TIMP2 and CXCL9 and associated, sensitivity, specificity, negative and positive predictive value.
* sensitivity, specificity, negative and positive predictive value of a urine leukocyte count cut-off of 200 cells/microL (validation)
* What is the optimal combination of biomarkers for UTI diagnosis in older patients
* As a secondary objective this study aims to evaluate the association between the levels of individual biomarker levels and 1) duration of symptoms 2) complications, 3) recurrence of UTI within 2 months, and length of hospital stay. Next to this, the performance of the astrego PA100 will be validated in diagnosing bacteriuria.

Participants will:

* be asked to provide a urine sample once at the beginning of the study
* be asked to answer some questions about their symptoms and overall health at the beginning of the study and after 8 weeks
* have their vital parameters (temperature and blood pressure) measured once at the beginning of the study


Eligibility Criteria:
Inclusion criteria:

* Age 65 years or older
* Clinically suspected UTI by treating physician
* Sufficient understanding of the Dutch language

Exclusion criteria:

* Inability to obtain urine
* Inability to provide written consent
* The presence of an indwelling catheter