cyrilzakka/clinical-trials huggingface dataset:
AI Assessment and Prediction Models for Geriatric Trauma

To fill up the research gaps and build up a healthcare service model for geriatric trauma patients, this two-stage study aims to (a) develop geriatric trauma Artificial Intelligence (AI) prediction models by comparing the outcomes from clinical assessment and AI joint images; and (b) examine the long-term effects of an innovative health service program in geriatric trauma patients.

Background: About 40% trauma patients will be over age 65 years by 2050, thus geriatric trauma constitutes an increasingly recognized problem that should be concerned. However, little is known about complicated causes of injury and long-term outcomes in older injured patients. Previous study strategies to promote health outcomes for geriatric trauma still are inconclusive. Due to the limited healthcare resources and workforce, health service for geriatric trauma care should be refined in the new era.

Expected outcomes/impacts: This study attempts to build up a modern healthcare model that may influence geriatric trauma care as well geriatric assessment. The AI prediction model can be used to quickly assess "degree of balance" for geriatric trauma patients. This study will involve a nursing student and healthcare professionals, and help them to learn how AI connects to geriatric trauma care. This would be an opportunity to cultivate potential experts for AI and healthcare. Last, the outcomes are highly associated with the government's policies related to smart health, smart healthcare, and long-term care workforce.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the hospital due to injury first time
* able to communicate in Mandarin
* agree to participate in this study from hospital discharge to one month after hospital discharge
* patients and their primary caregivers have smart mobile phones and internet access available
* can move independently before trauma

Exclusion Criteria:

* not frequent user for smart phones
* severe cognitive impairment
* victims of hangings and poisonings
Transfusion in Gastrointestinal Bleeding

Aim: To evaluate the feasibility and safety of a restrictive versus liberal red blood cell (RBC) transfusion policy in adult patients admitted with Acute Upper Gastrointestinal Bleeding (AUGIB) in order to inform the design of a definitive phase III randomised controlled trial.

Trial overview: TRIGGER is a pragmatic trial aiming to recruit adult patients admitted with all cause AUGIB (non-variceal and variceal). The study will take place in six United Kingdon hospitals and they will be randomly allocated to a transfusion policy at the cluster level; three sites will be allocated to a restrictive transfusion policy and three to a liberal transfusion policy. Given the challenges that will be involved in early recruitment and cross-speciality care, a feasibility study is essential to determine whether a sufficient proportion of eligible patients can be recruited into the trial and that clinicians can adhere to the allocated transfusion policy. Recruitment will operate for 6 months in total. The investigators will compare recruitment rate, protocol adherence, clinical characteristics of patients recruited, exposure to RBC transfusions and the difference in Hb concentrations between the restrictive and liberal transfusion policies. The investigators will collect important clinical outcomes which the investigators anticipate being central to the phase III trial, including 28-day mortality, further bleeding rates and serious adverse events between the restrictive and liberal transfusion policies. The investigators will also collect data to enable us to plan a health economic evaluation and quality of life assessment for the phase III trial.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 or over years presenting with AUGIB, defined by haematemesis or melaena.

Exclusion Criteria:

* Patients with whom the responsible clinician considers there is a need for immediate RBC transfusion prior to obtaining or regardless of the initial Hb result due to severity of bleeding.
* Existing hospital in-patients who develop AUGIB.
Noninvasive Modulation of Chronic Neuropathic Pain

This study will apply low-intensity transcranial focused ultrasound to dorsal root ganglia in patients with chronic neuropathic pain. The target will be validated using magnetic resonance imaging. The stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The level of pain will be evaluated using the Numerical Rating Scale (NSR-11) and the Patient-Reported Outcomes Measurement Information System (PROMIS) numerical rating scales of pain.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of chronic pain
* Moderate-to-severe chronic pain lasting at least 2 months
* Stated willingness to comply with all study procedures and avoid changes to current treatments (medications, physical therapy, cognitive behavioral therapy) for the duration of the study
* For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
* Capacity to provide informed consent; provision of a signed and dated consent form

Exclusion Criteria:

* Poorly managed general medical condition
* Pregnant or breast feeding
* Implanted device in the back
* Lifetime history of a serious suicide attempt
* Clinically inappropriate for participation in the study as determined by the study team
Patient Utilization of Opioid Destruction Bags in the Post-op Period

This is a study on how patients use and store opioid pain medications at home after surgery and what happens to left over pills when patients are done taking them. Participants will be taught the proper storage and destruction of opioid pain medications, then contacted in 6-8 weeks about pain medication used, stored disposed of.

This is a randomized single-center prospective survey study to describe the utilization of opioid destruction bags in the post-operative period. Participants who underwent surgery for Total Knee Arthroplasty (TKA) or Total Hip Arthroplasty (THA) will be eligible for inclusion if discharging to home with an opioid prescription. Eligible participants will be randomized between two groups: 1) Control group will receive current standard of care 2) Intervention group will receive a specialized handout and patient education on the safe storage of opioid medications, importance of opioid destruction, opioid destruction options and medication destruction (Deterra) bag before discharge. Participants will be phoned/emailed six to eight weeks post-surgery to complete a survey. Attempts will be made on three separate days to reach the participant via phone. If email is preferred, three reminders will be sent to complete the survey. If participant is unreachable, they will be considered lost to follow up. Survey questions will be comprised of various question styles, including: yes/no, multiple choice, and free text answers.

Eligibility Criteria:
Inclusion Criteria:

19 years of age or older Discharging to home and prescribed opioids at discharge post total knee arthroplasty or total hip arthroplasty

Exclusion Criteria:

Under 19 years of age Opioid medication use prior to surgery Not prescribed an opioid to take after discharge
A Phase I/II Study of VTX-801 in Adult Patients With Wilson's Disease

The objectives of this clinical trial are to assess, for up to 5 years, the safety, tolerability and pharmacological activity of a single ascending doses of VTX-801, a gene therapy, administered intravenously (IV) to adult patients with Wilson's Disease prior to and following background WD therapy withdrawal.


Eligibility Criteria:
Main Inclusion Criteria:

* Male or female aged 18 and 65 years inclusive
* Confirmed diagnosis of WD
* Treated for WD according to international recommendations with no current evidence for inadequate treatment
* Stable WD for ≥ 1 year, defined as: (i) No significant change in neurologic examination and in status of mood disorder and (ii) Stable laboratory parameters used to assess copper metabolism

Main Exclusion Criteria:

* ALT level ≥ 2 ULN that is not readily explained by extrinsic factors
* Total bilirubin \> 1.5 x ULN in the absence of proven Gilbert's syndrome; in case of Gilbert's syndrome, direct bilirubin \> ULN
* INR \> 1.2
* Any signs of liver cirrhosis decompensation, including gastrointestinal bleed within 6 months (24 weeks) prior to screening/enrollment visit
* Patient has moderate or severe renal impairment defined as eGFR CKD-EPI \< 60 mL/min/1.73 m2, or patient has nephritis or nephrotic syndrome
* Any history or current evidence of HIV-1, HIV-2, HTLV 1, or HTLV-2 infection
* Any history or current evidence of hepatitis B infection
* Any history of hepatitis C infection, unless previous viral RNA assays in two samples, collected at least 6 months apart, are negative
* Positive QuantiFERON®-TB Gold tuberculosis test result
* Any concomitant disorder/condition - including hepatic disorders - or treatment possibly interfering with the conduct or evaluation of the study
* Any history of diabetes
* Pregnancy or breastfeeding
* Body Mass Index ≥ 35 kg/m2

Other protocol defined Inclusion/ Exclusion criteria may apply
Safety of Aerius Syrup in Pediatric Patients Aged 1-5 Years Old With Allergic Rhinitis or Chronic Idiopathic Urticaria (Study P04446AM1)(COMPLETED)

The objective of this non-interventional study is to evaluate the safety of Aerius syrup in pediatric patients aged 1-5 years old with allergic rhinitis or chronic idiopathic uticaria. The patients will receive 2.5 ml (1.25 mg) once daily.

Pediatric patients aged 1-5 years

Eligibility Criteria:
Inclusion Criteria:

* Patients with allergic rhinitis or chronic idiopathic urticaria
* Aged 1-5 years old
* Caregiver's consent to participate

Exclusion Criteria:

* Healthy individuals
* Younger or older than the 1-5 year old age range
Incidence, Clinical Characteristics and Outcomes of Unstable Angina in the contempoRary Area.

The study aims to evaluate clinical characteristics and prognostic of a contemporary population of patients with UA defined using T hs-cTn measurements The study includes all patients admitted in 2 French university centers with the confirmed diagnostic of UA defined with clinical ischemic symptoms and T hs-cTn concentrations \< 99 percentile (undetectable: \<5ng/l or non-elevated: \<14ng/l), or ≥ 99 percentile but mildly elevated (14-50ng/l) .The primary end-point included major events at 1-year follow-up (total mortality, new ACS, hospitalization for cardiac causes).


Eligibility Criteria:
Inclusion criteria:

* Patients with ischemic symptoms at rest or minor exercise without evidence of acute myocardial necrosis.
* Ischemic symptoms may include typical or atypical angina pectoris and worsening/deterioration of previously stable angina with or without electrical signs of ischemia on the electrocardiogram.
* hs-cTn concentrations are in the normal range or may be slightly elevated \> 99th percentile (i.e. low troponin T elevation ≤ 50 \* Elecsys Roche) but with absence of significant kinetics according to criteria defined in the literature (\<20%).
* One of the following angiographic criteria is required:

  * Coronary angiography revealing a stenosis with a diameter of at least 70%.
  * Stenosis of at least 50% diameter in the left common trunk.
  * FFR (Fractional Flow Reserve) documenting ischemia per coronary angiography of a coronary lesion in the case of intermediate stenosis (50-70%).
  * If there are no significant lesions, a spasm must be proven by an ergonovine test.

Exclusion criteria:

* NSTEMI and STEMI.
* Coronaries normal or without significant lesions unless proven spasm.
Studying Tumor Tissue Samples From Patients With Soft Tissue Sarcoma

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor tissue samples from patients with soft tissue sarcoma.

OBJECTIVES:

* To develop a pilot program for the collection, archiving, and experimental analyses of soft tissue sarcomas (STS).
* To obtain STS tumors from cancer patients undergoing tumor removal or core needle biopsies.
* To evaluate cellular and molecular factors involved in STS oncogenesis by studying samples derived from human tumor specimens.
* To develop an accompanying bioinformatics database of the demographics of STS patients from which tumor specimens are derived for experimental study.

OUTLINE: Tumor tissue samples are analyzed for gene and protein expression by cDNA microarray analysis, RT-PCR, immunohistochemistry, in vitro transformation assays, RNA interference, and Western blot or immunoprecipitation.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * Patients with soft tissue sarcoma (STS) undergoing evaluation, treatment, and/or follow-up at the Arizona Cancer Center or University Medical Center
  * Patients undergoing surgical treatment for STS removal or core needle biopsy for medically indicated diagnostic or therapeutic purposes

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Home-based Gait Rehabilitation Service Using the Insole-type Gait Analysis Device for Children With Cerebral Palsy

Walking is a crucial daily activity that requires complex coordination of muscular systems. It is essential for bone and muscle health, cardiovascular fitness, and activities of daily living, making it an important indicator of prognosis and patient function. Insole gait analysis devices are affordable and easy to use, and they align well with standardized 3D gait analysis. However, their use outside of hospital settings is limited.

This study aims to assess the usability and satisfaction of utilizing insole gait analysis devices for monitoring and providing feedback on the walking status of children with cerebral palsy exhibiting walking impairments in a home environment. Additionally, adherence to a home-based exercise program developed in this study will be evaluated.

The screening test is conducted after obtaining consent, and it involves assessing whether the subject can independently walk more than 10 meters, regardless of the use of assistive devices, following an evaluation of their baseline symptoms and signs.

Subjects who pass the screening test are provided with information about their current walking status and what constitutes normal walking. Following the initial evaluation, they are instructed to participate in the 6-week home exercise program and how to record an exercise log. Additionally, researchers provide participants with an insole gait analysis device and instruct them on its operation, encouraging prolonged usage to ensure that usage time and walking patterns are recorded.

Based on the collected measurement data, feedback is provided over the phone at weeks 3 to 4. After completing the 6-week home exercise program, a final evaluation is conducted in the same manner as the initial evaluation. Satisfaction with the insole gait analysis device is assessed only at the time of the final evaluation.

Usage and satisfaction with the insole gait analysis device will be analyzed, and evaluation indicators will be compared before and after the home exercise program. Additionally, adherence to the home exercise program will be evaluated through exercise logs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with cerebral palsy aged 7 to 18 years old
2. Patients classified as Gross Motor Function Classification System level 1 or 2
3. Individuals who visited Severance Hospital, comprehended the study, agreed to participate, and submitted the informed consent form

Exclusion Criteria:

1. Individuals with complications such as severe foot deformities where the sensors of the insole gait analysis device cannot be recognized
2. In addition to above, individuals with clinically significant findings deemed inappropriate for this study by the study director or person in charge based on medical judgment
Early Treatment of Recurrent HCV- Infection Post Liver Transplantation in the Era of DAAs

The study aimed to present our experience in treating recurrent HCV genotype 4 infection post living donor liver transplantation (LDLT) since introduction of the second generation direct acting antiviral drugs (DAAs) in Egypt.

This was a cohort study conducted in patients who had undergone LDLT for HCV related disease from 2014 to 2016 at in Ain Shams Center for Organ Transplantation (ASCOT) .The hypothesis early initiation of DAAs( after 12 weeks of the operation ) is effective and safe strategy in transplant recipients following LDLT. Patients who take the sofosbuvir and ribavirin after 6 months after transplantation were compared with those who take early treatment after 3 months of transplantation with sofosbuvir and daclatsvir+/- ribavirin..Patients were on regular follow up visits monthly to assess the clinical condition, any side effects, laboratory tests including complete blood picture, liver functions , renal functions and trough level of immunosuppressant drugs.

Eligibility Criteria:
Inclusion Criteria:

* All transplanted patients for HCV related disease in the period from 2014 to 2016

Exclusion Criteria:

* Patients transplanted for other causes rather than HCv
* Patients with HBV and HCV co infection
Asthma Severity in Children and Environmental Agents

This study measures residential exposures (indoor allergens, mold, nitrogen dioxide, nicotine) and relates exposure levels to daily symptoms (wheeze, persistent cough, chest tightness, shortness of breath) and medication use, in a population of children with physician diagnosed asthma, followed for 12 months.


Eligibility Criteria:
* Siblings of a birth cohort recruited 1997-1999
* Age less than 11 years
* Physician diagnosed asthma
* Active symptoms (wheeze, persistent cough, chest tightness, shortness of breath) or medication use in the 12 months prior to enrollment.
Salvage Living Donor Liver Transplantation for HCC Beyond All Criteria Yield Equivalent Results to Milan Criteria

The present study aims to evaluate the impact of expanding criteria beyond Milan on tumor recurrence and patient survival that will help identify the best selection criteria for HCC transplanted patients.

Introduction:

HEPATOCELLULAR CARCINOMA (HCC) is the second leading cause of cancer mortality worldwide. Living donor liver transplantation (LDLT) for HCC patients has emerged as a rewarding therapy for a cure and a successful alternative where a Deceased donor liver transplantation (DDLT) program is lacking. Therefore, trials for careful expansion to Milan criteria have been adopted.

Aim of the study:

To evaluate the impact of expanding criteria beyond Milan on tumor recurrence and patient survival that will help identify the best selection criteria for HCC transplanted patients

Eligibility Criteria:
Inclusion Criteria:

* All patient transplanted for HCC eligible for transplant (no vascular invasion-no extra hepatic metastasis)
* age\>18y

Exclusion Criteria:

* other etiology for liver transplant rather than HCC
* patient not fit for surgery
* age \>70y
Rehabilitation Programmes for Scapholunate Instability

Two different exercises approaches were tested in patients with Scapho-Lunate (SL) instability; one to strengthen the tendons in static positions and the other to strengthen the tendons whilst the wrist is moving.

Scapho-Lunate (SL) instability is the most common form of wrist instability, but is complex to diagnose and is often missed entirely. The natural progression of SL instability has been suggested to lead to osteoarthritis. The management of SL instability can be broadly divided into conservative and surgical, with the former being the first option taken by most medical professionals, which primarily involves physiotherapy. The evidence base for physiotherapy management of SL instability is limited; however cadaver research has identified loading some of the wrist tendons may stabilise the scaphoid and lunate.There is currently no research as to whether this clinically makes any difference to the patients symptoms, or how to do it. This research therefore aimed to test the protocol and methods, and act as a platform for larger studies, to investigate this.

Two different exercises approaches were tested; one to strengthen the tendons in static positions and the other to strengthen the tendons whilst the wrist is moving.

Eligibility Criteria:
Inclusion Criteria:

* Ages eighteen to sixty,
* wrist pain,
* confirmed scapholunate ligament disruption on MRA or XR (partial or full),
* referred from orthopaedic wrist specialist,
* for conservative management,
* consent to trial.

Exclusion Criteria:

* Under eighteen or over sixty years,
* previous fracture,
* degenerative changes in the wrist,
* previous surgery,
* complex regional pain syndrome or diagnosis of rheumatological conditions,
* no wrist injection in preceding twelve months or other wrist conditions.
Improving Sleep Quality After Total Joint Arthroplasty ( TJA)

The purpose of this study is the evaluate and improve sleep quality after Total joint replacement.

Patients in early stage after TKA tend to suffer from sleep problem. Sleep disturbances frequently occur in patients after surgery, and its occurrence is harmful for postoperative recovery. Many factors can affect the quality of sleep after a major surgery including anesthesia-type, narcotic use and discomfort due to pain or restricted leg movements. Pain directly leads to sleep disruption or even deprivation and, in turn, poor-quality sleep aggravates pain sensation. There seems to be a vicious circle: pain - poor-quality sleep - intensified pain - even poorer-quality sleep.

Presumably, if a patient suffers from catastrophizing, depression and anxiety , the result of TKA will be worse due to poor sleep.

Eligibility Criteria:
Inclusion criteria -Adults 18 years and older

Exclusion criteria -

1. No chronic pain
2. Patients underwent revision or bilateral surgery.
3. Patients underwent fracture.
4. Patients suffering from dementia / delirium
5. Patients on narcotics greater than 10mg hydrocodom before surgery
6. Not willing to participate