cyrilzakka/clinical-trials huggingface dataset:
System to Avoid Fall Events

Rinicare Ltd, a Lancaster-based SME, and University Hospitals of Morecambe Bay Trust (UHMB) will collaborate on a research study to determine the feasibility, suitability, and acceptability of the Rinicare developed SAFE (System to Avoid Fall Events) fall prevention and detection system in a hospital environment. The study is designed to determine if the implementation of the SAFE system will help clinicians to prevent in-patient falls from hospital beds. In-patient falls are a serious problem with more than 245,000 incidents reports in 2015-2016. 77% of these falls involve a patient over the age of 65, and the injuries patients suffer due to falls is estimated by NICE to cost the NHS £2.3B annually. This study will test the performance of the SAFE technologies against the current interventions to prevent falls, and it will investigate the impact of the SAFE technology on the workflow of the carers.

The SAFE study is designed as a comparison study combining a descriptive, quantitative methodology measuring the number of fall events with a normative analysis of the qualitative aspects experienced by the clinicians using the SAFE system during the project period.

The primary research objective of this study is to determine if the implementation of the SAFE system will quantifiably reduce the number of fall events in the ward compared to a similar control period. The secondary research objective is to determine if the SAFE system has a positive or a negative impact on the ward staff's workflow, i.e. the ability of the ward staff to provide care to the patients.


Eligibility Criteria:
Inclusion Criteria:

Patients who are deemed by the ward clinicians to be at risk of falling from the bed due to one or more of the following reasons:

* Frailty due to old age (E.g. 65 years or older)
* Frailty due to medical conditions (E.g. hypotension)
* Frailty due to mental conditions (E.g. dementia)
* Frailty due to physical conditions (E.g. amputation or injury)
* Frailty due to medication(s)

Patients who are able to give informed consent will be included. In addition, any patients who are unable to consent to participation in this study due to a lack of mental capacity but are assessed by the ward matron to benefit from participation in this study will also be included. Where possible, consent will be obtained from close relatives or legal guardians in this case. These patients are a particularly vulnerable group and their interests must therefore be protected. They should be given the same opportunities to participate in ethically designed research projects as those who do not lack capacity but must not be put at unwarranted risk.

Exclusion Criteria:

Patients under 18 years of age Patients who are in an unconscious or comatose state, physically restrained to the bed, or otherwise completely unable to move under their own power and thus not at risk of falling out of their bed
Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles

The investigators are proposing to use a wearable device, MultiSenseTM, developed by Rhythm Diagnostic Systems, Inc. which has many sensors inside in a "Band-Aid" like strip in order to see if it can help diagnose capabilities in individuals suspected of having obstructive sleep apnea. The MultiSenseTM sensor is a self-contained, reusable, rechargeable, battery-powered, flexible strip, measuring 4 X 1.2 inches that simultaneously tracks and records a number of physiological health related parameters such as ECG, heart rate, pulse synchronized oxygen saturation, temperature, respiratory rate, depth of respiration and motion/position. One advantage of this device over current home diagnostic systems is the capability for recording over several nights.

The objective is to compare multiple biometric parameters tracked by the MultiSenseTM to gold standard monitoring in an accredited sleep lab using polysomnography. Home monitoring will explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights. Enrolling 10 adults already scheduled for a medically indicated sleep study will help us to make these determinations. Subjects will wear the device, which is the size of a Band-Aid, via adhesive to their chest over a period of 10 days. Subjects will go about their normal daily activities and return the device via mail once completed.


Eligibility Criteria:
Inclusion Criteria:

* Adults over age 18
* Considered to be at high likelihood for sleep apnea and already scheduled for a formal sleep study.

Exclusion Criteria:

* Congestive heart failure or other major medical illness that would complicate the diagnosis of OSA.
* Psychological or social situation that would make the study difficult for the patient.
Dry Eye Screening and Referral System

Dry eye is one of the most common ocular surface diseases. Its pathogenic factors are related to multiple etiology. Because of the complexity of the pathogenesis of dry eye, the diversity of related examinations, and the inconsistency of symptoms and signs of dry eye patients, the diagnosis of dry eye has higher requirements on the professional technology and examination equipment of ophthalmologists.

The purpose of this study is to establish a case-control cohort of dry eye patients. Multimodal data will be collected from participants, including medical history information, ocular surface disease index scale (OSDI), anterior segment photography, and treatment outcome of dry eye patients. The correlation between the characteristics of anterior segment images and dry eye diagnosis will be explored by artificial intelligence algorithms. The purpose of this study was to develop an artificial intelligence dry eye screening and referral system.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects whose age are greater than or equal to 18 years old;
2. Subjects who can cooperate with the inspection;
3. Subjects who agree to participate in the study and sign the consent form.

Exclusion Criteria:

1. Subjects who cannot do the inspection.
2. Subjects who suffer from diseases that compromise the inspection.
Genetic and Immunologic Basis of COVID-19 Infection

We will study genetic factors causing severe disease due to infection with SARS-COV-2 which may help to find targeted therapy


Eligibility Criteria:
Inclusion Criteria:

* severe COVID-19 infection

Exclusion Criteria:

* Comorbidity ((DM, hypertension, Chronic liver or Kidney diseases, HIV, morbid obesity, Malignancy, Immunosuppressive therapy)
Examining Carryover Effect in Patients Treated witH Spinal cOrd Stimulation (ECHO)

Spinal cord stimulation is a minimally invasive surgical treatment for severe, chronic, neuropathic pain that is refractory to conventional treatment.

The treatment consists of an electrode implanted in the epidural space of the spinal cord, either via a percutaneous approach (using the so-called percutaneous leads) or via a surgical (hemi-) laminectomy (using the so-called surgical leads or plate leads).

It is a well-known clinical observation that when activating or deactivating SCS stimulation, there is a variable interval before the patient perceives a clinical effect of the change. This variation goes by different names (carryover, echo, after effect, etc.) and might be dependent on the clinical condition and treatment duration. To our knowledge only very little research has been published on the topic of carryover effects; a recent study showed that the interval is highly variable between patients.

While patients may experience immediate pain relief at the onset of SCS treatment, the effect in patients with a long-term SCS treatment history may have different characteristics, possibly due to ongoing changes in the nervous system.

The aim of this pilot study is to lay the foundation for investigating the carryover effects in spinal cord stimulation.

This will be carried out in a mixed population of patients with different indications for SCS, and with different treatment durations.

Patients will be asked to deactivate their device via their remote control or with a magnet in a standardized fashion.

They will be asked to reactivate the device when specific parameters have been met, and the time is recorded.

In the post-hoc analysis the carryover and reverse carryover effect will be analyzed and correlated to a number of parameters including, but not limited to: Indication, treatment duration, symptom duration, preoperative pain score, stimulation paradigm, gender, age.

Data will be collected and stored using a dedicated REDCap database under the auspices of Aarhus University.

Eligibility Criteria:
Inclusion Criteria:

* patient age minimum 18 years
* signed informed consent
* implanted with full SCS system for neuropathic pain
* SCS treatment duration minimum 6 months before inclusion
* maximum pain score 7 or less on a 0-10 NRS at the area of pain treated with SCS during the last 48 hours before study-related deactivation of the device

Exclusion Criteria

* any surgical SCS lead revision for the last 6 months before inclusion
* any changes in the programming patterns of the device (except patient-controlled changes in amplitude) for a minimum of 30 days before the study-related deactivation of the device
* any other ongoing neuromodulatory treatment (PNS, TENS, etc.)
* any other neuromodulatory treatment with lasting effect (RFA, sympathectomy, infiltration anesthesia, nerve blockade) within the last 60 days
* any changes in analgetic medication within the last 30 days (pn. dosings are allowed)
Role of Immune Activation in Response of Head and Neck Squamous Cell Carcinoma to Therapy

The purpose of this study is to investigate the role of the immune system in the response of squamous cell cancers of the head and neck to treatment that includes radiation therapy. Current research demonstrates that several natural immune cells and molecules affect the way the body's immune system interacts with a cancerous growth. Some cancers may be related to infection with a virus, such as the Human Papilloma Virus (HPV). Studying the activity of the immune system in head and neck cancers, especially cancers related to HPV infections, can provide valuable information to better understand the body's interaction with cancer cells.

This is a study of the immune response in patients with oropharyngeal cancer who undergo treatment with radiation, chemoradiation, or robotic surgery. Many oropharyngeal cancers are caused by infection with the human Papillomavirus (HPV), and patients with HPV-mediated tumors have much better prognosis and treatment response compared to patients with HPV-negative tumors. The investigators will test the hypothesis that radiation-based therapy of oropharyngeal cancer is associated with activation of the endogenous HPV-specific immune response. In this study the investigators will collect blood at several time points before, during, and after treatment to monitor the immune response in patients with tumors positive and negative for HPV versus normal healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* The patient has biopsy-proven squamous cell carcinoma, Stage II-IV, of the oropharynx or larynx.
* The patient is to undergo treatment with radiation, chemo-radiation, or robotic surgery.
* The patient is able to give informed consent.
* The patient is at least 18 years old.
* The patient's ECOG performance status is \</=2.

Exclusion Criteria:

* The patient has had prior head and neck squamous cell carcinoma, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
* The patient has active cancer in another part of the body, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
* If a cancer survivor, the disease free interval is less than 5 years, with the exception of superficial cutaneous basal cell or squamous cell carcinomas.
* The patient is a minor.
* The patient is pregnant.
* The patient is a prisoner.
* The patient is incapable of understanding the consent process.
* The patient has previously received definitive surgical, radiation, or chemoradiation treatment for HNSCC.
* The patient has a history of HIV or other known cause of immunosuppression, or is actively taking immunosuppressive medications due to organ transplantation, rheumatoid disease, or other medical conditions.
Thyroid Hormone Supplementation in Patients With Septic Shock

The primary aim of the study would be to determine whether there is a difference in survival in the Intensive Care Unit between the group of patients with septic shock diagnosed with euthyroid sick syndrome who were treated with T3 hormone compared to the group of patients not treated with this hormone. Secondary objectives of the research would be:

Compare the level of thyroid hormones between the examined groups and

1. laboratory indicators of septic shock (C-reactive protein-CRP, procalcitonin, leukocytes, acid-base status, lactates)
2. APACHE II, SOFA and SAPS II patient assessment scales,
3. inflammatory prognostic systems (ratio of CRP and albumin-modified Glasgow prognostic score-mGPS, ratio of neutrophils and lymphocytes - NLR, ratio of platelets and lymphocytes - PLR, and ratio of leukocytes and CRP, prognostic index - PI)
4. hemodynamic stability of patients (MAP, systolic and diastolic pressure) in the periods of admission T0, T3, T6, T12, T24 and every 24 hours for 4 days,
5. effect of vasoactive drugs,
6. the need for mechanical ventilation categorized as yes or no, in case - number of respirator days,
7. length of stay in the Intensive Care Unit,
8. treatment outcome categorized as 28 day survival.


Eligibility Criteria:
Inclusion Criteria:

* all patients who meet the criteria for septic shock according to the definition of Surviving sepsis campaigning (The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016): persistent hypotension requiring the use of vasoactive drugs to maintain mean arterial pressure ≥65 mm Hg ; blood lactates\> 2 mmol / L despite adequate resuscitation volume,
* patients with laboratory-proven euthyroid sick syndrome, according to diagnostic criteria which include: normal levels of TSH hormone, low levels of T3 hormone that may accompany low levels of T4 hormone (depending on the stage of critical disease) and absence of previous primary thyroid and pituitary disease.

Exclusion Criteria:

* age below 18,
* patients with a history of thyroid disease or an enlarged thyroid gland,
* psychiatric patients,
* patients on hormone therapy (excluding insulin),
* those taking amiodarone, corticosteroids or dopamine
* pregnant or postpartum mothers 6 months ago,
* patients who refuse to participate in the study
Comparing Hand-sewn (END-TO-END or Kono-S) to Stapled Anastomosis in Ileocolic Resection for Crohn's Disease

The aim of this multicenter randomised controlled trial is to compare the handsewn (end-to-end and Kono-S) to the stapled side-to-side ileocolic anastomosis after ileocolic resection for Crohn's disease with respect to 6 months endoscopic recurrence, functional outcome and health care consumption.

Within the surgical IBD society there has been a lot of attention to technical aspects of ileocolic resection aiming to reduce recurrent Crohn's disease after surgery. Despite optimal surgical and medical management, recurrent disease after surgery is common. Different types of anastomoses with respect to configuration and construction can be made after resection e.g., handsewn (end-to-end and Kono-S) and stapled (side-to-side). The various types of anastomoses might affect endoscopic recurrence and its assessment, the functional outcome, and costs. It is hypothesised that patients who had an end to end reconstruction will have less endoscopic recurrence (less overscoring, and less stases), a better function and consequently health care consumption than the stapled side to side anastomosis.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged \>16 years
* Ileocolic disease or disease of the neoterminal ileum with an indication for resection
* Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted.
* All patients should have undergone a colonoscopy and a recent update of imaging (e.g. Ultrasound, MR enterography (or CT enterography if MR is contraindicated))- Ability to comply with protocol.
* Competent and able to provide written informed consent.
* Patient must have been discussed in the local MDT

Exclusion Criteria:

* Inability to give informed consent.
* Patients less than 16 years of age.
* Clinically significant medical conditions within the six months before the operation : e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
* History of cancer \< 5 years which might influence patients prognosis
* Emergent operation.
* Pregnant or breast feeding.
* Inability to follow up at 3, 6 and 12 months for postoperative assessment, imaging and endoscopy.
Helius in Hypertension-I: The UK Hypertension Registry

The purpose of this study is to demonstrate the use of a digital health offering in the management of persistent hypertension during chronic anti-hypertensive treatment.

In patients with persistent essential systolic hypertension,who are undergoing assessment of their current pharmaceutical burden for blood pressure control, a digital health offering is used (1) to provide automatic and passive electronic documentation of medication adherence and patterns of medication taking, (2) to assist providers in distinguishing inadequate medication adherence or pharmacologic unresponsiveness as the root cause for persistent hypertension, and (3) to inform management decisions (dose adjustment, medication addition or substitution, adherence counseling, referral to a hypertension specialist).

Participating patients wear an adhesive Wearable Sensor ("Patch") continuously with replacement after one week, and ingest an inert tablet ("Pill") containing an Ingestible Sensor daily whenever they take their prescribed anti-hypertensive drugs.

The Patch automatically detects and records the dates and times of each "Pill" ingestion, daily step count, sleep duration and sleep interruptions, and the circadian pattern of rest and activity. After completion of each Patch's use, the recorded data are downloaded and incorporated into a report that includes blood pressures that are obtained at the time of clinic visits at the beginning and after 2 weeks of service use.

The final report is generated automatically and provided electronically to practitioners for review with their patient. The information that is obtained is incorporated by practitioners in advising next steps for blood pressure management.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of age ≥ 18 years
* Essential hypertension, consisting of:

  1. Blood pressure ≥150 or ≥90 during chronic treatment with 2 or more drugs for patients ≥80 years of age; or,
  2. Blood pressure ≥140 or≥90) during chronic treatment with 2 or more drugs for patients \<80 years of age
* Ability to read and understand the instructions for participating
* Capacity to read and to speak English proficiently
* Capacity to provide informed consent

Exclusion Criteria:

* History of skin sensitivity to adhesive medical tape or metals
* History of acute or chronic dermatitis
* Any other condition that in the investigators opinion would compromise patient safety while participating
* Alcohol or other substance abuse
* Terminal illness
Clinical and Genomic Factors for Prognosis of AIDS Primary Effusion Lymphoma

This research trial studies clinical factors and gene expression analysis for prognosis in tissue samples from patients with acquired immune deficiency syndrome (AIDS)-related primary effusion lymphoma. Gathering health information over time and studying samples of tissue from patients in the laboratory may help doctors learn about the prognosis of patients with AIDS-related primary effusion lymphoma.

PRIMARY OBJECTIVES:

I. Identify baseline clinical characteristics and treatment strategies in patients with AIDS-associated primary effusion lymphoma (PEL) that correlate with long-term survival (\>= 2 years). (Primary clinical objective) II. Identify differentially expressed genes in PEL that are associated with long-term survival (\>= 2 years). (Primary genomic objective)

OUTLINE:

Medical chart review is performed and patient information is collected regarding human immunodeficiency virus human immunodeficiency virus (HIV)/AIDS medical history, staging of AIDS related malignancy, and type of treatment. Previously collected tissue samples are analyzed via ribonucleic acid (RNA) sequencing and microarray.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with primary effusion lymphoma (HIV seropositive or negative) on or after January 1, 1998 on whom survival status at 2 years post PEL diagnosis is available
* Participants may be enrolled to either or both the clinical or genomic portions of the study
* The minimum data required to be able to include a subject for analysis of clinical prognostic factors are:

  * HIV status, and for HIV subjects include cluster of differentiation (CD)4 count, HIV viral load closest to time of diagnosis
  * Age at PEL diagnosis
  * Gender
  * Stage at diagnosis
  * Treatment of PEL
  * Response to treatment
  * Survival status at 2 years
  * Pathology slides (or paraffin block) for central review
* The minimum data required to be able to include a subject for analysis of genomic prognostic factors are:

  * Availability of a pathologic specimen of PEL that will be submitted for genomic analysis
  * Survival status at 2 years

Exclusion Criteria:

* Patients who do not fulfill the criteria as listed above are ineligible
Efficacy of Prazosin Versus Placebo Associated With Peg-Interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis

Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis.

Treatment of hepatitis C with interferon and ribavirin has a virological effect. Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. In vitro studies of prazosin suggest an effect against hepatic fibrosis, but the clinical effect of prazosin on the hepatic fibrosis induced by hepatitis C infection is unknown. The purpose of this multicentric national study is to compare the effects among the hepatic fibrosis of peg-interferon alpha 2b and ribavirin with prazosin or not (placebo). 112 patients with a viral hepatitis C, genotype 1 or 4, and severe fibrosis, will be randomly assigned to one of two treatment groups: peg-interferon alpha 2b and ribavirin, with prazosin or with placebo. Peg-interferon alpha 2b will be administered once a week (1.5 micro g per kg) during 48 weeks, ribavirin 1,000 to 1,200 mg per day (according to weight) during 48 weeks, prazosin/placebo 5 mg (2 pills) per day during 96 weeks. Evaluation will be done at 96 weeks. The primary end-point is the proportion of patients presenting a decrease of fibrosis. Secondary end-points are other criteria of histological response, virological response, biochemical response.

Eligibility Criteria:
Inclusion Criteria:

* Chronic viral hepatitis C, genotype 1 or 4
* Fibrosis F3 or F3-F4, assessed by the scoring Metavir system
* Initial treatment against HCV

Exclusion Criteria:

* Psychiatric pathology
* Alcool consummation
* Pregnancy or plan of pregnancy
* Breastfeeding