cyrilzakka/clinical-trials huggingface dataset:
A Comparison of XELOX Regimen and EOX Regimen as Neoadjuvant Chemotherapy Regimen for Locally Advanced Gastric Cancer.

This study is designed to assess what is the better neoadjuvant chemotherapy regimen for patients with initially unresectable locally advanced gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* more than 2 regional bulky lymph nodes macroscopic tumor type is either the Borrmann type 4 or large type 3 tumor invades adjacent structures (T4b)

Exclusion Criteria:

* peritoneal metastasis confirmed by CT scan lung metastasis, liver metastasis, pleural effusion, and/or other distant metastasis
Clinical Diagnosis of Acute Porphyria

The purpose of this study is to test whether a focused questionnaire and laboratory tests can better define risk factors associated with possible genetic porphyria. The investigators hypothesize that the genetic carrier state of acute porphyria is distinctive enough that the Genetic Carrier Profile the investigators devise through this study will be useful in identifying carriers of genetic porphyria among the large population with undiagnosed abdominal pain.

The porphyrias are a group of genetic diseases caused by disturbances in the formation of heme, an essential component of hemoglobin and other proteins, leading to either acute (neurologic) and/or chronic (cutaneous) symptoms. Acute porphyria is often difficult to diagnose because symptoms may not be specific and, unless the patient is in an active attack, laboratory values typically may not be useful for diagnosing porphyria. The purpose of this study is to test whether a focused questionnaire and laboratory evaluation tool can better define risk factors associated with possible genetic porphyria. The goals of this study are:

* To determine the presence and number of abnormal lab tests and porphyria-like symptoms in adult family members of the first person in a family who has been diagnosed with a disease of acute porphyria, 50% of whom are expected to carry the same genetic defect of the index case.
* To devise a Genetic Carrie Profile that could be used to screen people in whom the diagnosis of porphyria is being considered.
* To test the Profile in patients with symptoms suggestive of HCP and/or urine tests showing some elevation of porphyrins.
* To explain other possible causes of minor increases in porphyrin levels in patients with recurrent abdominal pain who have not been diagnosed with porphyria

Eligibility Criteria:
Group 1 Inclusion Criteria:

* Be 15 years of age or older
* Be a first-degree relative (child, sibling, parent, or grandparent) of an individual with genetically proven acute porphyria (AIP, HCP or VP)
* Not have had any previous genetic testing for acute porphyria

Group 2 Inclusion Criteria:

* Be 15 years of age or older
* Have a history of suggestive clinical features, such as abdominal, back or limb pain, recurrent nausea lasting days, reaction to medications, psychiatric history, or sun sensitivity.
* An increase in urinary, fecal or serum porphobilinogen (PBG) and/or porphyrins

Groups 1 and 2 Exclusion Criteria:

* Have previously had genetic testing for acute porphyria
* Have a history of "alarm" symptoms, such as anemia, unintentional weight loss, signs of GI (gastrointestinal) bleeding, or dysphagia (difficulty in swallowing).

Follow Up Sub-Study (Group 3) Inclusion Criteria:

* Have been seen by one of the Porphyria Consortium physicians/investigators 10 or more years prior to study initiation
* Had a slight increase in porphyrins during the initial visit
* Not given a diagnosis of porphyria at the time of the visit

Follow Up Sub-Study (Group 3) Exclusion Criteria:

* You have been seen by the Porphyria Consortium physician/investigator less than 10 years prior to study initiation.
Prevalence of Gabapentinoids and Opioids in Geriatric Falls Patients

This study investigates the prescription patterns of gabapentinoids (gabapentin and pregabalin) in a geriatric fall clinic in Aalborg, Denmark, between 2013 and 2023. Gabapentinoids, often prescribed for neuropathic pain, have seen increased off-label usage, particularly as alternatives to opioids. Despite the lack of robust evidence supporting their efficacy in many neuropathic and non-neuropathic pain conditions, their use has grown, especially in elderly populations. This raises concerns about their potential side effects, such as drowsiness, dizziness, and the risk of falls, especially when combined with opioids.

The study aims to determine the prevalence of gabapentinoid and opioid prescriptions in the clinics and for what type of pain they are prescribed. Furthermore, the study will look into the development in opioid prescriptions and concomitant gabapentinoid/opioid usage in this population.

The study is a retrospective chart review of patient charts from the years 2013-2014, 2018-2019, and 2023, analyzing patient characteristics, comorbidities, medication lists, and pain classifications.


Eligibility Criteria:
Inclusion Criteria:

* patient in the geriatric fall clinic at Aalborg University Hospital in either 2013-2014, 2018-2019, or 2023

Exclusion Criteria:

* None
Trekking Poles to Aid Multiple Sclerosis Gait Impairment

In this study, the investigators will examine a sample of persons with multiple sclerosis (MS) to determine whether their walking function and ability is different depending on which walking assistive device is used.

In this study, the investigators will examine a sample of persons with multiple sclerosis (MS) to determine whether their walking function and ability is different depending on which walking assistive device is used. In addition, the investigators will examine the psychosocial impact and amount of fatigue induced by each assistive device. Data collection will consist of a series of assessments via survey and physical performance. The analyses will consist of appropriate comparisons of means to determine if the use of different assistive devices alters any of the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Be 18-64 years old with a confirmed diagnosis of MS
* Have perceived walking difficulty
* Have an EDSS score of \< 6, calculated by the physician
* Ability to understand study procedures and to comply with them for the entire length of the study

Exclusion Criteria:

* Have had a MS exacerbation in the prior 8 weeks
* Have other serious medical conditions that would impair their ability to participate in gait performance testing (i.e. severe rheumatoid arthritis or osteoarthritis)
* If the physician deems a participant unsafe to go home with devices
* Cannot communicate in English
* Possess greater than a mild decrease in mentation (i.e. a score of \>2 on the Mental Functions item of the FSS)
* Inability or unwillingness of individual to give written informed consent
MRI-based Biomarkers for Predicting Punctate White Matter Lesions in Neonates

As a common white matter (WM) disease in preterm neonates, punctate white matter lesion (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. However, it is lack of certain methods in identifying the prognosis of PWML. Through using various advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter longitudinal study would be conducted to follow-up the PWML neonates with varying spatial-position and degree lesions. Through tracking the variations in WM microstructures from neonate period to childhood (2 years old and 3 years old), this study aims to explore (1) the potential relations between varying PWMLs and motor and visual disorders (2) the relations between WM MRI-metrics and neurodevelopmental assessment results, and thus determine the early biomarkers to identify CP and amblyopia.


Eligibility Criteria:
Inclusion Criteria:

-(1) Age: 1-28 days (2) PWML (3) High quality MRI scan

Exclusion Criteria:

-(1) Congenital malformations, infections, metabolic disorders, intraventricular hemorrhage (2) Neonates of mothers with gestational diabetes, hypertension, hypoglycemia and history of alcohol
IMPACT OF COMPUTERIZED GLOVE ON FACILITATING HAND FUNCTION RECOVERY AND NEURAL PLASTICITY IN STROKE

Hand impairment post-stroke is a common condition that contributes to disability around the world. An effective intervention is required to optimize functional outcomes in the rehabilitation of hand-in-stroke patients.

Thirty male/female stroke patients in the sub-acute phase were randomly assigned in to the two groups (study and control) in sets of three. The study group (A) (n = 15) underwent a hand rehabilitation program using the computerized glove combined with the selected hand program. The control group (B) (n = 15) received only the selected hand program. The treatment schedules for 18 consecutive treatment sessions, three times per week.

Eligibility Criteria:
Inclusion Criteria:

1. The patient's age ranges from 45 to 65 years old with a minimum score of 24 points on the Mini Mental Test.
2. Duration of illness ranges from (6weeks to 6 months) after stroke onset.
3. first stroke.
4. Upper limb spasticity ranged from 1+ to 2 according to the Modified Ashworth Scale.
5. With a minimum 10° extension and/or flexion of the wrist or fingers, an ability to flex and extend the wrist joint five times continuously without losing active range of motion.

Exclusion Criteria: Patients with the following

1. apraxia or hemianopsia.
2. diabetic polyneuropathy.
3. Aphasia , cognitive deficits.
4. a previous disability in the upper limbs, tactile agnosia (stereognosis).
5. LT hemiplegia, Post Botox injection, recurrent stroke, and Posterior parietal lesion.
DEXRAR: DEXamethasone in Revision ARthroplasty

Trial name: DEXRAR: Dexamethasone in revision arthroplasty: A randomised, blinded, 2-group clinical trial

Trial acronym: DEXRAR

Background: Effective postoperative pain management is essential for the well-being and rehabilitation of the surgical patient. No "gold standard" exists for pain treatment after revision total knee arthroplasty (TKA) and combinations of different medications are used with virtually no evidence for combined analgesic efficacy.

Objectives: The objective is to investigate the analgesic effect and safety of dexamethasone as a single dose after revision-TKA in combination with paracetamol, ibuprofen and local infiltration analgesia

Intervention: The patients are randomised into to groups: A) 24 mg dexamethasone i.v. B) isotonic saline i.v.

Design and trial size: Placebo controlled, parallel 2-group trial with adequate centralised computer-generated allocation sequence and allocation concealment with block size of 12. Blinding of assessor, investigator, caregivers and patients.

Sample size: 108 eligible patients are needed to detect a difference of 11,3 mg morphine for the first 24 h postoperatively with a standard deviation of 20 mg, a type 1 error rate of 0,05 and a type 2 error rate of 0,20.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for unilateral, revision-TKA: Total and major partial revisions were included, i.e. revisions including the femoral and/or the tibial component(s).
* Age \> 18
* American Society of Anesthesiologists (ASA) physical status classification system ASA 1- 3.
* Body mass index (BMI) \> 18 and \< 45
* Women in the fertile age (i.e. until one year after menopause) must have negative urine human chorionic gonadotropin (HCG) pregnancy test
* Patients who gave their written informed consent to participating in the trial after having fully understood the contents of the protocol and restrictions.

Exclusion Criteria:

* Patients who cannot cooperate with the trial.
* Concomitant participation in another trial involving medication
* Patients who cannot understand or speak Danish.
* Patients with allergy to medicines used in the trial.
* Patients with daily use of methadone.
* Contraindications against NSAID, for example previous ulcer, heart failure, liver failure, or renal failure (eGRF \< 60 ml/kg/1,73m2), known thrombocytopenia (\<100 mia/L)
* Patients suffering from alcohol and/or drug abuse - based on the investigator's judgement.
A Study of Transcutaneous Electrical Stimulation As a Noxious Stimulus for the Glasgow Coma Scale

The purpose of this study is to determine whether electrical stimulation can be used to replace physical stimulation to test awareness of patients with impaired consciousness. Physical stimulation can cause bruising, damaged nails and ribs, and other damage with repeated testing, and electrical stimulation may be safer and cause less distress with time. This device has not been approved by the U.S. Food and Drug Administration (FDA).

For patients enrolled in this study, the study doctor or study staff will give non-invasive electrical stimulation to measure response. Depending on what study group, the study team may apply this stimulation several times at one (Phase 1) or two (Phase 2) separate time points approximately 2 hours apart (when GCS would normally be collected as part of clinical care). In addition to GCS using normal physical stimulation, the study team will test responses to electrical stimulation. To do this, electrodes (special wired stickers that conduct electricity) will be placed on the forehead, finger, and toe. Stimulation will be applied to one area at a time by connecting the electrode to a stimulator. For each physical and electrical stimulation, response will be measured (such as flinching, opening eyes, making sounds, etc.). The goal is to create electrical stimulation patterns that cause the same response as the physical exam without causing any physical damage.

A video recording will also be taken of the participant's telemetry unit (the screen showing their heart rate and other vital signs throughout the study. This video, in addition to the information from the participant's medical record, is to make sure that there are no unexpected changes in vital signs during the study. The participant will not be visible on this video.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is admitted to the Barrow Neurological Institute's neuro ICU
2. Patient is in a comatose state, which is defined as a patient who is both non-responsive and has a GCS eye or motor response sub-score that requires noxious stimulation
3. Age greater than or equal to 18 years
4. Patient has an available surrogate decision maker with the capacity to consent for participation in a research study

Exclusion Criteria:

1. A neurologic decline immediately prior to study participation that requires urgent or emergent workup or management\*
2. Patients in whom the frequency or extent of neurologic assessments is being limited due to concern that noxious stimulation may provoke intracranial hypertension, cardiorespiratory instability, or other adverse events
3. Patients with an implantable or external pacemaker that is currently in use
4. Ongoing refractory cardiorespiratory instability
5. Pregnant females
6. Prisoners
Postconditioning by Cyclosporin A in Pulmonary Transplantation

The morbidity and mortality of patients undergoing lung transplantation in the acute phase following surgical intervention is mainly due to the primary graft failure (PGF).

The occurrence of PGF is multi factorial but is mainly caused by ischemia-reperfusion injury. The pulmonary graft suffers two periods of ischemia one when it is explanted from the donor (cold ischemia) followed by another when it is grafted into the recipient's thoracic cavity (warm ischemia). The brutal reperfusion of the graft exposes it to reperfusion injury that causes PGF. PGF occurs in up to 20% of transplanted patients and is associated with significantly higher levels of 30-days all-cause mortality. Patients with PGF have a 40% mortality at 30-days versus a 6% mortality in patients without PGF.

Ischemic postconditioning, has recently been described in experimental models of ischemia-reperfusion injury in the heart, and although not yet fully understood. Several studies suggest that the mitochondria play a central role in cellular survival mechanisms after a prolonged period of ischemia-reperfusion (with the mitochondrial permeability transition pore (mPTP)).

Experimental studies have shown that cyclosporin A (CsA) administered prior to reperfusion binds to cyclophilin D and blocks the opening of mPTP after reperfusion. This protective effect of ischemia-reperfusion injury by CsA has been shown in experimental studies and in clinical phase II trials in reperfused myocardial infarction patients.

The hypothesis of this study is that the administration of CsA in transplanted patients (before re-opening of the first pulmonary graft vessels) protects the transplanted lung(s) from the deleterious effects of ischemia-reperfusion injury and thus reduce the frequency and severity of PGF.


Eligibility Criteria:
Inclusion Criteria:

* All patients over 18 years old, man or woman, who are listed for pulmonary transplantation either mono or double lung transplantation.

Exclusion Criteria:

* No contra-indication to CsA administration.
Effect of Antiviral Therapy on HVPG in Patients With Viral Cirrhosis

Complications associated with portal hypertension are the leading cause of death in patients with cirrhosis. Until now, hepatic venous pressure gradient (HVPG) - the difference between the wedged hepatic venous pressure (WHVP) and the free hepatic vein pressure (FHVP)- has been the criterion standard to determine portal pressure. Antiviral therapy may decrease HVPG which needs to be verified.


Eligibility Criteria:
Inclusion Criteria:

* Patients with viral cirrhosis were diagnosed;
* Age 18-80 years;
* Need and willing to accept measure HVPG;
* First HVPG measurement of more than 5 mmHg;
* Signed Informed Consent

Exclusion Criteria:

* Patients with viral cirrhosis have been treated with antiviral therapy and have achieved virological response;
* Ready to accept or have accepted a TIPS procedure;
* Splenic embolization was performed;
* Inaccurate measurement of HVPG due to combined hepatic venous shunt;
* Complicated with alcoholic liver disease, autoimmune liver disease or other types of liver disease;
* Complicated with liver cancer or other organ malignancy;
* Combined with severe cardiopulmonary disease affects survival;
* Complicated with severe renal insufficiency;
* Concomitant portal vein cavernous degeneration or extensive portal vein thrombosis;
* Women who are planning to become pregnant or who are pregnant or breastfeeding.
Body Composition Monitoring(BCM) for Determination of the Fluid Status in Patients Undergoing General Anesthesia

The purpose of this study is to evaluate a recently developed device, which measures body composition (i.e. the water content of the body) in the perioperative setting. Specifically the investigators will test the hypothesis, that extracellular water content after surgery correlates to the amount of intraoperative infusion and positive fluid balance. Furthermore the investigators will test, if preoperative evaluation of body water helps to determine intraoperative fluid requirements and to guide fluid administration.

Patients undergoing anesthesia and surgery receive intravenous fluids during the procedure. The amount of administered fluid depends on the type of surgery, cardiovascular stability and intraoperative losses like hemorrhage. Fluid overload as well as hypohydration might be detrimental and might adversely effect outcome after surgery. Specifically overhydration results in significant weight gain, tissue edema and increased morbidity. Technically assisted assessment of volume status before surgery may be useful to direct intraoperative fluid administration and to prevent postoperative volume overload. As a prerequisite the investigators will test a recently developed whole-body bioimpedance spectroscopy device to determine the pre-to postoperative fluid distribution. This body composition monitor (BCM, Fresenius Medical Care, Germany) separates between extracellular and intracellular fluid volume non-invasively by applying a frequency sweep from 3-1000 kilohertz through the entire patient via electrodes placed on the wrist and ankle.

The investigators will test the hypothesis that

1. the amount of administered fluid correlates with the amount of overhydration measured postoperatively.
2. that preoperative BCM measurements and thus information about the preoperative hydration state might help to guide fluidmanagement and to reduce the amount of over/ hypohydration postoperatively.

Eligibility Criteria:
Inclusion Criteria:

18-80 Years

Exclusion Criteria:

liver, heart, kidney failure, patients with pacemaker
Artificial Intelligence System for Assessing Image Quality of Slit-Lamp Images and Its Effects on Diagnosis

Slit-lamp images are widely used in ophthalmology for the detection of cataract, keratopathy and other anterior segment disorders. In real-world practice, the quality of slit-lamp images can be unacceptable, which can undermine diagnostic accuracy and efficiency. Here, the researchers established and validated an artificial intelligence system to achieve automatic quality assessment of slit-lamp images upon capture. This system can also provide guidance to photographers according to the reasons for low quality.


Eligibility Criteria:
Inclusion Criteria:

* Patients should be aware of the contents and signed for the informed consent.

Exclusion Criteria:

* 1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
* 2. Patients who do not agree to sign informed consent.
A Study to Investigate Lung Deposition of Inhaled Amikacin-loaded Liposomes in Healthy Male Participants

The primary purpose of this study is to determine the intra and extra pulmonary deposition and clearance of inhaled amikacin-loaded liposomes by gamma scintigraphy in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a body mass index (BMI) of 20-28.
* Participants with negative human immunodeficiency virus (HIV) and Hepatitis B and C results.
* Participants with no clinically significant findings in 12-lead electrocardiogram (ECG) determined within 14 days of the start of the study.

Exclusion Criteria:

* Participants who had clinically diagnosed asthma.
* Participants with a known allergic reaction to amikacin, liposomes or any of the radiolabelling products (i.e. \[\^99m\]Tc, or \[\^111\]In, and \[\^81m\]Kr).
* Evidence of clinically significant pulmonary, renal, hepatic, cardiovascular or metabolic dysfunction.
* History of smoking within the past 12 months.
* History of chronic cough or wheezing within the previous 21 days.
* Participants who had an upper respiratory illness or infection within the previous 21 days.
* A history of drug or alcohol abuse.
* Donation of 450 milliliters (mL) or more blood within the previous 12 weeks.

Note: Other inclusion/exclusion criteria may apply.