cyrilzakka/clinical-trials huggingface dataset:
Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - an Observational Study

For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 24/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. The WARD-COPD project aims to determine the correlation between cardiopulmonary micro events and clinical adverse events during the first four days after hospital admission with acute exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted with AECOPD
* Recruitment and monitoring start is possible within 24 hours after admission

Exclusion Criteria:

* Patient expected not to cooperate
* Patient allergic to plaster, plastic or silicone
* Active therapy withdrawn
* Patients with dementia or not able to give informed consent
* Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit
* Expected discharge within less than 24 hours from possible inclusion
Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia

The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Men or women between 18 and 60 years (extremes included)
* BMI of ≤38
* Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)
* Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at screening and baseline
* PANSS total score ≤80
* Score ≤4 (moderate) on the following PANSS items at screening and safety baseline: P7 (hostility), G8 (uncooperativeness)
* Willing to be hospitalised for 4 to 5 weeks after the Safety Baseline Visit

Exclusion Criteria:

* The patient experienced an acute exacerbation requiring hospitalization within the last 6 months
* The patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks
* The patient has a diagnosis or history of substance dependence (except nicotine) or substance abuse according to DSM-IV-TR® criteria ≤3 months prior to screening
* The patient smokes \>20 cigarettes per day

Other protocol-defined inclusion and exclusion criteria may apply
Evaluation of Therapeutic Effect of 0.5 mg Colchicine and 5 mg Prednisolone on Oral Aphthae

The purpose of this study is to determine whether low doses of prednisolone, or colchicine are effective in the treatment of oral aphthae.

Treatment of recurrent aphthous stomatitis (RAS) remains, to date, empirical and non-specific. The main goals of therapy are to minimize pain and functional disabilities as well as decrease inflammatory reactions and frequency of recurrences.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of clinical diagnosis of aphthae
* Having the experience of oral aphthae at least once in a month
* Two weeks wash out periods after the last treatment

Exclusion Criteria:

* History of any systemic disease
* Using drugs which affect immune system
* Pregnancy and breast feeding
* Aphthous related syndromes
The Effect of Different Degree of Temperature on Levobupivacaine Spinal Anesthesia

This study will be conducted to evaluate the effect of different temperature on the spinal anesthesia characteristics and incidence of complications

Regional anesthesia techniques are also superior to systemic opioids agents with regard the analgesic profile and adverse effects .Spinal anesthesia is the most commonly used technique due to its unmatchable reliability,simplicity and cost-effectiveness. It provides a fast and effective onset of sensory and motor block, excellent muscle relaxation and prolonged postoperative analgesia .

Bupivacaine is commonly used local anesthetics because of its long duration of action and combined motor and sensory blockade. However, it has many drawbacks .It has a high propensity to cause hypotension and bradycardia. There is also cardiac toxicity.Levobupivacaine is an attractive alternative to bupivacaine because of the lower affinity for cardiac sodium channels and reducing the risk of cardiac toxicity.Moreover ,the isobaric levobupivacaine had more stability in cerebrospinal fluid and thus lead to more predictable drug spread, decreasing the incidence of hypotension and bradycardia. But its main disadvantage is the delayed onset .

A number of strategies have been used to hasten the onset of local anesthesia .The addition of fentanyl mixtures of local anesthetics and alkalization of the local anesthetics all shorten the onset time of sensory block. Recently the warming of the anesthetic agents (namely, lidocaine and bupivacaine) to 37° C hastens the sensory block in various surgical settings .

Up till now there is no study suggestive of any appropriate degree of temperature as adjuvant .Hence the present study will be conducted to evaluate the effect of different temperature on spinal anesthesia characteristics and the incidence its complication

Eligibility Criteria:
Inclusion Criteria:

* ASA-I or II

Exclusion Criteria:

* patient refusal; Any known hypersensitivity or contraindication to levobupivacaine pregnancy bleeding disorders local skin infections. Sepsis at the site of injection Coagulation abnormality Psychiatric disorders
An fMRI Study of Opioid-related Changes in Neural Activity

The purpose of the study is to explore the effect of blocking opioids on affiliation-related neural activity.


Eligibility Criteria:
Inclusion Criteria:

* good health
* between the ages of 18 and 35,
* fluent in English
* right-handed (for the fMRI scan)

Exclusion Criteria:

* Self-reported current or past diagnoses of physical or mental illness.
* Score on the Patient Health Questionnaire (depressive symptoms) above a 13
* Positive urine drug test (for Tetrahydrocannabinol (THC), Opiates, Cocaine, Amphetamine (AMP), and Methamphetamine (mAMP))
* Positive urine pregnancy test
* Use of any prescription medication, except for birth control
* Use of any over-the-counter medications on the day of the fMRI session and 24 hours after the fMRI session
* Self-reported problems with liver functioning, including hepatitis or liver failure
* Difficulty swallowing or taking pills
* BMI greater than 35 or weight greater than 400 lbs
* Claustrophobia
* Nonremovable metal in the body
Effect of Naltrexone in Achieving and Maintaining Abstinence From Alcohol in Patients With Cirrhosis.

The aim of the study is to study the safety and tolerability of Naltrexone in patients with Alcohol liver disease over a 12 week duration without liver related side effects. The project will be conducted at ILBS from March 2020 to February 2021. The concept is to estimate the usage of naltrexone and establish its safety in cirrhotics and study its effect on achieving and maintaining abstinence and in reducing lapses and relapses. Thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality.

All ALD patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives. In case of any reactions, the drug will be stopped as per the study stopping rule.

After following the inclusion and exclusion criteria, ALD patients will be recruited into the study. It's a double blind RCT, hence both the patient and the investigator will be blinded and the drug will be issued by the trial co-ordinator after taking informed written consent and explaining the side effects. Naltrexone at a dose of 50 mg per day and placebo are included in the tablets. Placebo tablets will be identical in size, colour, shape, and taste. Naltrexone tablets will be entrusted to a family member to administer every dose and monitor for side effects.


Eligibility Criteria:
Inclusion Criteria:

1. All consecutive alcohol dependent cirrhotic aged between 18-60 yrs.
2. Fulfilling DSM - 5 criteria for alcohol use disorder (Association, 2013).

Exclusion Criteria:

1. Current Hepatic Encephalopathy
2. Total Bilirubin \> 3 mg/dl.
3. Recent bleed.
4. Treatment with corticosteroids within the past 60 days.
5. Unwilling to participate.
6. Dependence on any other substance (except Nicotine).
7. Psychotic disorder requiring treatment/Suicidal tendency.
Cytochrome P450 2C19 Variant is Related to Pharmacokinetics of Glipizide Extended Release Tablet in Chinese Subjects

Diabetes mellitus is a growing global disease now and future, and in China, 1.2 million peoples per year have been diagnosed as diabetes mellitus. 90% diabetes mellitus patient is Type 2 diabetes mellitus. Glipizide is a potent drug to service patients who suffer from Type 2 disease. Little information has been presented for the relationship between CYP2C19 genetic polymorphism and glipizide, since recently the investigators reported that there existed a tendency. In this study the investigators found that CYP2C19 polymorphism significantly influenced the pharmacokinetics of glipizide.

Blood samples were obtained from 127 unrelated healthy male Chinese subjects in Gansu Province. After genotyping, 14 subjects (age, 19-26; weight, 59.5-70.0 kg) were enrolled in the study. They were divided into two groups, EMs homo and PMs group. There were no significant differences in age or body weight seen in the two groups.

Each subject received 5 mg glipizide extended release tablet once daily for 7 days. For the first 6 days, glipizide was administered just after a standard breakfast. On day 7, after an overnight fast, each subject received a glipizide extended released tablet (Glucotrol XL, Pfizer, USA) with 100 mL water. Standard meals were given in 4 h and 10 h after dosing. Venous blood samples were collected immediately before and at 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 36, and 48 h after dosing. Blood samples, collected in EDTA tubes, were centrifuged (2500 g) immediately for 10 min and plasma samples separated were stored at -80ºC until assay.

For safety, blood glucose levels were determined directly by use of a Glucose Meter (Accu-Chek, Roche, Germany) at 0, 2, 4, 6, 8, 10, 12, 14, 16, 20and 24 h after last dosing (on day 7).

Eligibility Criteria:
Inclusion Criteria:

* male
* healthy
* nonsmokers

Exclusion Criteria:

* BMI \> 24 or BMI \< 19
* had any family history of diabetes mellitus
Generating Novel Translational and Therapeutic Strategies Based on a Multicenter, Pediatric and AYA Evolutionary Tumor Board (pedsETB)

To evaluate the ability of a multidisciplinary and multisite group, the Pediatric Evolutionary Tumor Board (pedsETB), to develop additional therapeutic strategies in patients without curative options or with suboptimal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be considered likely incurable given the standard of care. This is inclusive of patients newly diagnosed, relapsed or in remission but at high risk of recurrence, with suboptimal responses to previous therapy, or with many potentially beneficial, but unlikely curative options for care.

The site investigator will make this determination based on their experience.

* Participant must have an age-appropriate performance status: Karnofsky 50 or more for patients 16 years of age or older OR Lansky score of 50 or more for patients less than16 years of age.
* Participant and/or parents or legal guardian and primary oncologist must be willing to consider the therapeutic strategies recommended by the pedsETB.
* Participant must be willing to be followed over time and allow collection of clinical data including scans, available blood and lab samples, and optional pedsETB serial blood sampling.
* All Participants and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.

Exclusion Criteria:

* Participants without known therapies to reliably induce a response are excluded from pedsETB and should seek clinical trials.
Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation

To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-75 yr
* Willingness to provide written informed consent
* Ability to understand the study procedures

Exclusion Criteria:

* Life expectancy \< 3 months
* Claustrophobia
* Allergy to iodinated contrast
* Treatment incompliance
* Pregnancy
* Highly HLA-sensitized patients
* Severe dyslipidemia or proteinuria
* Severe leucopenia or thrombocytopenia
* GFR \< 30 ml/min
Measuring the Effect of Chair Massage on Stress Related Symptoms for Nurses

The purpose of this study was to assess the feasibility and effect of chair massage provided during working hours for nurses in an inpatient psychiatric and an outpatient pain rehabilitation unit and on the nurses stress related symptoms.

Nursing staff working in a hospital in-patient psychiatric unit and out-patient pain rehabilitation/ fibromyalgia units each have varying causes of stress as both are intensely demanding environments. The physical and psychosocial demands of these stress-loaded work environments place a significant amount of strain on the physiological well-being of the employee.

Nurses in these settings are considered healthy employees and able to participate in the workforce, although symptoms such as headaches, shoulder tension, insomnia, fatigue, and muscle and joint pain are often a part of their work day. As these stress related symptoms become more chronic, they lead to days missed and become pre-cursors to physiological illnesses so warrant further search for prevention tactics.

Massage therapy has been noted to decrease levels of anxiety and fatigue which is essential to maintaining employee's efficient care in a dynamic environment. This study will provide massage in the workplace utilizing chair massage as it is easy to set up, does not need a great deal of space, and can be provided in semi-private areas, as the participant remains clothed. A 2006 report on a small study indicated chair massage can be effective in reducing stress perception in nurses within a hospital setting, at least in the short-term. Another study reported some short-term positive effects on stress related symptoms; and came to the conclusion that further studies are indicated to examine the efficacy of workplace-based massage therapy programs.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18-65 able to give informed consent
* Able to speak and understand English
* Minimum of 8-hour per day shift schedule with .75 - 1.0 FTE.
* Need to be able to schedule one massage per week in the available massage schedule time slots.

Exclusion Criteria:

* Individuals being treated for acute musculoskeletal symptoms
* Individuals currently on work restrictions
* Undergoing treatments for a malignancy
* Pregnancy (due to this being chair massage)
* Recent head, neck, shoulder or back surgeries
* Pins or joint fusion of the head or neck
* Current sinus infections, earaches, or vascular migraines
* Nursing staff that float on to the unit
Angioplasty + SBCV vs. Angioplasty Alone for Femoropopliteal Artery Stenosis

The purpose of this study is to compare balloon angioplasty plus SBCV against balloon angioplasty alone for treatment of stenosis within the femoropopliteal artery.

This first-in-human study will evaluate the safety and effectiveness of a novel adjunctive therapy, SBCV, used with balloon angioplasty as compared to balloon angioplasty plus a control agent (saline) when used for the treatment of stenosis within the femoropopliteal artery. Effectiveness will be measured by late lumen loss at 24 weeks post treatment as evaluated by an independent, blinded core lab.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for balloon angioplasty for stenosis of femoropopliteal lesion(s)
* Rutherford Clinical Category 1-4 (claudication or critical limb ischemia)
* Lesions are ≥70% stenosis by visual estimate
* A patent inflow artery free from significant lesion
* At least one patent native outflow artery to the ankle

Exclusion Criteria:

* History of haemorrhagic stroke within 3 months of screening
* History of myocardial infarction, thrombolysis or angina within 2 weeks of screening
* Renal failure or chronic kidney disease
* Severe calcification that renders the lesion undilatable
Metastatic Prostate Cancer Men's Attitudes Towards Treatment of the Local Tumour and Metastasis Evaluative Research

Systemic therapy (i.e Androgen Deprivation Therapy with Docetaxel, Enzalutamide, Apalutamide or Abiraterone Acetate) has increased overall survival in men with hormone-sensitive metastatic prostate cancer.

Novel local cytoreductive treatments and metastasis directed therapy are being evaluated, these can confer additional harm, but might improve survival.

We aim to elicit men's preferences for and willingness to accept trade-offs between potential improved survival and cytoreductive treatment risks using a 'discrete choice experiment'.

OBJECTIVES: To determine the attributes associated with treatment that are most important to men with hormone-sensitive metastatic prostate cancer (mPCa). To determine men's preferences for, and trade-offs between, the attributes (survival and side-effects) of different treatment options in metastatic prostate cancer including systemic therapy, local and metastases-directed physical therapies.

PHASE: Prospective multi-centre observational cohort

DESIGN: Discrete choice experiment, single-visit, electronic questionnaire design

SAMPLE SIZE: Multi-centre Stage (Stage 3) n = 300 patients

POPULATION: Men with newly-diagnosed metastatic prostate cancer who have not consented to a form of local cytoreductive or metastasis directed therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with prostate cancer within 4 months of screening visit
2. Performance status 0-2

Exclusion Criteria:

1. Castrate-resistant metastatic prostate cancer
2. Patient has consented to a form of local cytoreductive treatment to prostate
3. Patient has consented to a form of metastasis directed therapy
Impact of Inspired Oxygen Fraction on Outcome in Patients With Traumatic Brain Injury

Aim of the study is to investigate the impact of two different fractions of inspired oxygen (FiO2) on outcome in patients with severe traumatic brain injury (TBI).

The high oxygen group is treated during mechanical ventilation with either a fraction of inspired oxygen of 0.7 (high oxygen group) or a fraction of inspired oxygen 0.4 (control group). The intervention continues until withdrawal of mechanical ventilation, ICU discharge or until 14 days from ICU randomisation.

Primary outcome is worse than expected outcome in the corresponding treatment arms based on outcome meas-ured by the probability of bad outcome using the CRASH® risk calculator (prognostic model for predicting outcome after traumatic brain injury).

Secondary outcome is occurence of lung injury during mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with isolated non-penetrating traumatic brain injury
* Multiple trauma patient with brain injury and traumas outside abdomen, thorax or pelvis not affecting oxygenation
* Glasgow coma scale eight or less (inclusive)
* Expected need for intubation and for mechanical ventilation more than 24 hours.
* Are recruited \<18 hours after admittance to ICU and
* Time from TBI is less than 36 hours
* Informed consent from patients representative

Exclusion Criteria:

* Age \<18 or \>65 years,
* Anticipated brain death in 12 hours (donor treatment) or otherwise moribund patient expected to die in 24 hours
* Expected need for mechanical ventilation less than 24 hours
* Insufficient oxygenation assessed by a clinician or multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation.
* No consent
* Insufficient oxygenation with the treatment modality of the lower oxygenation group (Pa02 less than 13 kPa or SpO2 95% with Fi02 40%, PEEP 10 or less) or oxygenation failure probable during ICU care (severe aspiration, multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation)
* Penetrating TBI
* No consent
* Suspected pregnancy (perform urinary or serological pregnancy test if suspected)
The Role of Quantitative Measures on Dual-energy CT in the Prediction of Colorectal Adenocarcinoma

To demonstrate the potential role of dual-energy computed tomography (DECT) by iodine maps data, aimed at discriminating colon cancer from colon wall pseudo-thickening.

Prospectively, 50 consecutive patients with pathology-proved colorectal tumor (detected by optical colonoscopy) who undergo routine thoraco-abdominal DECT for initial staging in the Department of Radiology at our institution from April 2020, will be included. The exclusion criteria are as follows: patients with body mass index (BMI) above 30 kg/m2, patients with renal insufficiency (estimated glomerular filtration rate \< 30 ml/min), allergy to iodinated contrast and a known history of previous abdominal radiotherapy.

All patients will undergo a staging enhanced thoraco-abdominal CT by 256-slices CTs (Revolution CT, GE healthcare) at Fribourg hospital. DECTs will be acquired without an enema, rectal insufflation or oral contrast to have collapsed colorectal wall for further measurements and to simulate routine clinical practice. No additional screening procedures, such as a laboratory or diagnostic tests are necessary for the present study.

Upon acquiring 50 patients, CT quantitative assessments will be performed. Initially, data will be transferred to AW Advantage workstations (GE Healthcare). Thereafter, for each patient, the iodine map images will be created by post-processing by. All CT quantitative measurements will be performed independently by two radiologists. Three regions of interest (ROI) will be applied to colorectal tumor and the normal collapsed colorectal wall (confirmed previously by colonoscopy) and consequently, the mean of these measurements will be reported. These measurements correspond to mean iodine uptake of colorectal tumor and normal collapsed wall, respectively. Finally, the iodine uptake of the tumoral lesion and normal collapsed wall in each patient will be compared to demonstrate the significant difference in iodine uptake. Investigators anticipate that the obtained cut-off value will be a new benchmark in clinical practice, to exclude the colorectal tumors on non-prepared collapsed colon wall and eliminate the need for a complementary colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

. pathology-proved colorectal tumor

Exclusion Criteria:

* BMI above 30 kg/m2
* renal insufficiency (estimated glomerular filtration rate \< 30 ml/min),
* allergy to iodinated contrast, and a
* known history of previous abdominal radiotherapy