cyrilzakka/clinical-trials huggingface dataset:
Ramelteon and Citicoline for Delirium

Primary aim of this study is to assess the feasibility of conducting clinical research for delirium (confusion due to medical problems) at Clements University Hospital in Dallas, Texas. A secondary aim is to assess whether an FDA-approved sleeping aid called Ramelteon or an over-the-counter supplement called Citicoline are safe and beneficial in delirium.

This will be a 5-day, non-randomized, open-label, consecutive case series of ramelteon treatment followed by a separate consecutive case series of citicoline treatment, both running in parallel with a non-randomized, observation-only, treatment as usual arm in hospitalized patients with delirium.

On the drug treatment arm, first five consecutive subjects meeting Diagnostic and Statistical Manual (DSM)-5 criteria for delirium will be given ramelteon 8 mg daily at bedtime for 5 days. The next five consecutive patients will be given citicoline 250 mg daily at bedtime for 2 days, followed by 500 mg daily at bedtime for 3 days. Patients on the observation-only arm will be screened and followed similarly, except they will not be given any experimental drugs. All subjects will continue to receive standard medical care for delirium, including optimal medical treatment, psychotropic medications and consultations with specialty services as necessary.

The study is a small pilot to see if there is good feasibility, tolerability and a signal for delirium improvement efficacy with the two medications. The goal is to develop the ability to conduct delirium research at this institution and obtain some preliminary pilot data. These data will be used to design and obtain funding for future, larger research studies. the data from each medication will be examined to look for patterns suggesting that one may be preferable for further research. However, given the very small sample size, meaningful between-group statistical analyses are not possible.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to inpatient units commonly known as 12-South or 12-North at Clements University Hospital
* Has capacity to give informed consent OR legally authorized representative is available at bedside
* Expected duration of hospitalization longer than 48 hours
* Fluent in English
* Can be screened by study physician within 24 hours of admission

Exclusion Criteria:

* History of angioedema or any other allergic reaction with previous ramelteon therapy
* Pregnant or currently breast-feeding
* Concurrent use of fluvoxamine
* Severe hepatic impairment
* Severe obstructive sleep apnea
Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.

To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.

2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.

Eligibility Criteria:
Inclusion:

* healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.

Exclusion:

* children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs;
* children having received any additional pneumococcal vaccine than in the primary study;
* children with any disease that affect the immune system and history of seizures and/or allergic disease.
Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients

The purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability.

Hemodialysis patients experience higher rates of cardiovascular morbidity and mortality than the general population and many populations with other chronic diseases. This exceptional risk is explained in part by known risk factors such as diabetes, hypertension, and other uremia-related factors, including vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating inflammatory mediators. However, additional unidentified risk factors also likely contribute to the disproportionately high prevalence of cardiovascular morbidity in hemodialysis patients. Blood pressure variability may represent one plausible cardiovascular risk factor. Data from nonuremic human populations show an association between greater blood pressure variability and cardiovascular events,nonfatal cardiovascular events,stroke,and increased left ventricular mass. There has been comparatively little work examining the causes and effects of blood pressure variability in hemodialysis populations. So the purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years or older
* receipt of thrice-weekly in-center hemodialysis
* no anticipation of imminent(\<6 months)living related kidney transplant
* not transfer of care to a nonparticipating facility
* no dialytic modality change
* free of vascular, infectious, or bleeding complication within 1 month Exclusion Criteria:
* who missed \>2 hemodialysis treatments over 1 month
* abused drugs
* severe anemia，malnutrition，chronic atrial fibrillation
* body mass index of 40 \>kg/m2
BOTOX® (Botulinum Toxin Type A) as Headache Prophylaxis in Chinese Participants With Chronic Migraine

This study will evaluate the efficacy and safety of BOTOX® (Botulinum Toxin Type A) compared with placebo as headache prophylaxis in Chinese participants with chronic migraine.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic migraine prior to the baseline phase based on the revised criteria for chronic migraine listed in International Classification of Headache Disorders (ICHD)-3 beta (2013)
* Fifteen or more headache days during the 4-week baseline phase, with each day consisting of 4 or more hours of continuous headache
* Routine non-headache medications of stable dose and regimen for at least 1 month prior to the start of screening.

Exclusion Criteria:

* Participants diagnosed with any of the following headache disorders: Familial hemiplegic migraine, Sporadic hemiplegic migraine, Migraine with brainstem aura, Migrainous infarction, Chronic tension-type headache, Hypnic headache, Hemicrania continua, New daily-persistent headache and Recurrent painful ophthalmoplegic neuropathy
* Participants with a confirmed history of medication overuse headache
* Participants with a diagnosis of retinal migraine, persistent aura without infarction or migraine-triggered seizure
* Headache attributable to another disorder (eg, cervical dystonia, craniotomy, head/neck trauma)
* Use of any headache prophylactic medication within 28 days prior to the start of the screening
* Any medical condition that may put the patient at increased risk with exposure to Botulinum Toxin Type A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interfere with neuromuscular function
* Participants with a known or suspected Temporomandibular Disorder (TMD), including pain in or around the Temporomandibular Joint (TMJ)
* Participants with a concurrent diagnosis of fibromyalgia
* Previous treatment with botulinum toxin therapy for any reason, or immunization to any botulinum toxin serotype
* Acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, nociceptive trigeminal inhibition or occipital nerve block treatments, or injection of anesthetics or steroids into the study target muscles within 28 days prior to the start of the screening
* Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
The Impact of Epigenetic MMRd in Endometrial carcinomas-a Real World Study

In recent years, the incidence of endometrial carcinoma (EC) has increased significantly and patients tends to be younger. In addition to known risk factors such as obesity, hypertension and diabetes, genetic factors also play an important role in the occurrence and development of EC. Among them, Mismatch Repair Defect (MMR) can produce mutant phenotypes, leading to cancer susceptibility. Although some articles indicated that epigenetic MMRd, one type of MMRd, predicted poor prognosis among endometrial carcinoma patients, hitherto, the clinicopathological significance and prognosis of epigenetic MMRd has not been determined. To date, there are no relevant large-sample data to investigate the prevalence of epigenetic MMRd in Chinese population, as well as the impact on the prognosis of endometrial cancer. In this setting, The purpose of this study was to investigate the prevalence of epigenetic MMRd and its impact on clinicopathology and prognosis on endometrial cancer among Chinese patients.

We conducted a retrospective real-world study of all endometrial carcinoma cases from 2019 to 2022. The inclusion criterion is all patients diagnosed with endometrial cancer in our hospital from 2019 to 2022 and exclusion criteria are those without histological specimens in our hospital. After immunohistochemistry and MLH1-promoter methylation testing, tumors were classified into 3 groups according to status of mismatch repair defects. Tumors with MMR abnormalities by IHC and MLH1 methylation were classified as epigenetic MMR deficiency while those without MLH1 methylation were classified as probable MMR mutations, and those without MMRd were classified as MMR proficient. The first outcome is the prevalence of epigenetic MMRd in endometrial cancer, and the second outcome is Whether the clinicopathological features and prognosis of endometrioid adenocarcinoma differ between the epigenetic MMRd population, MMR proficient population and the Lynch/ Lynch-like population.

Eligibility Criteria:
Inclusion Criteria:

* all patients diagnosed with endometrial cancer in our hospital from 2019 to 2022

Exclusion Criteria:

* those without histological specimens in our hospital
Biomarkers to Detect Mesothelioma Early in Patients Exposed to Asbestos or Vermiculite

RATIONALE: Studying samples of body fluid and blood from patients who have been exposed to asbestos or vermiculite in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking for biomarkers to detect mesothelioma early in patients exposed to asbestos or vermiculite.

OBJECTIVES:

* Identify patients with known asbestos exposure at early stages of disease development (i.e., indolent premalignant pleural plaques and fibrosis vs malignant pleural mesothelioma).
* Determine the expression levels of tumor-associated proteins in these patients.
* Analyze samples of serum and pleural effusions obtained from these patients.
* Determine the proteomic profile of samples obtained from these patients.
* Determine the molecular mechanisms associated with the regulation of the extracellular matrix microenvironment proteins (e.g., osteonectin, intelectin, or matrix metalloproteins) involved in disease onset and progression.

OUTLINE: This is a multicenter study.

Patients undergo collection of body cavity fluid, including pleural effusion, and blood. Specimens, including fresh frozen malignant pleural mesothelioma tumor tissue, if available, are analyzed for proteomic profile, gene expression profile, and tumor-associated protein expression levels.

PROJECTED ACCRUAL: A total of 200 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Exposure to vermiculite or asbestos insulation

  * Symptomatic or nonsymptomatic exposure-related disease
* Seen at a clinic in Libby, Montana (CARD Clinic) or Michigan (COEM)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Study Comparing Pursestring Wound Closure vs Conventional Closure to Reverse Stoma of Colorectal Cancer Patients

Temporary stomas has been performed to reduce complications after colorectal cancer surgery, especially in high-risk anastomosis. Different closure technics showed different outcome. The aim of this study is to compare the scar length , surgical site infection and pain score of purse-string wound closure vs conventional closure.


Eligibility Criteria:
Inclusion Criteria:

* Receiving temporary ostomy because of colorectal cancer at least 3 months ago;
* Age of≥18 and ≤80

Exclusion Criteria:

* Not willing or incapable to comply with all study visits and assessments
* Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that puts the patient at high risk for treatment-related complications
Validation of the Utility of an Intelligent Visual Acuity Diagnostic System for Children

Visual development during early childhood is a vital process. Examining the visual acuity of children is essential for the early detection of visual abnormality, but performing such an assessment in children is challenging. Here, the investigators developed a human-in-the-loop artificial intelligence (AI) paradigm that combines traditional vision examination and AI with integrated software and hardware, thus making the vision examination easy to perform. The investigator also establish a entity intelligent visual acuity diagnostic system based on the paradigm, and conduct clinical trial to validate if the diagnostic system can offsetting the shortcomings of human doctors.


Eligibility Criteria:
Inclusion Criteria:

* Paediatric patients from eye clinic written informed consents provided
Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors

This study is a multi-center, single-arm phase I clinical trial. A total of 26\~42 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.

An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period


Eligibility Criteria:
Inclusion Criteria:

* 1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.

  2.At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes.

  3.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.

Exclusion Criteria:

* 1.Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment.

  2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Risk of major bleeding as assessed by investigators. 4.Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function.

  5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy .

  6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;
Efficacy and Safety of a Multiple-Action Tear Substitute (TriMix) in Dry Eye Disease

The objective of the study is to assess the efficacy and safety of TriMix tear substitute in patients with dry eye disease. For this purpose, a randomized, double-blind clinical trial has been designed, using an Hyaluronic acid-based tear substitute as a control.


Eligibility Criteria:
Inclusion Criteria:

1. Self-reported history DED while working with computer screens ≥ 6 hours per day.
2. ocular surface disease index (OSDI) \> 13 points.
3. non-invasive tear film break-up time (NIBUT) \< 10 s.
4. Schirmer test (ST) without anesthesia ≥ 5 mm.
5. MGD grade ≤ 1. For MGD, the Sirius device (CSO, Florence, Italy) was used, which determines MGD grade based on loss area of meibomian glands (LAMG). MGD grade was scored from 0 to 4 (MGD grade 1 = LAMG \< 25%; MGD grade 2 = LAMG ≥ 25% and \< 50%; MGD grade 3 = LAMG ≥ 50% and \< 75%; MGD grade 4 = LAMG ≥ 75%).

Exclusion Criteria:

1. abnormal lid anatomy, including active blepharitis, and active lid margin.
2. all corneal disorders that affect diagnostic test, such as active corneal infection and corneal dystrophies.
3. active ocular allergies.
4. vectored thermal pulsation (VTP) intense pulse light (IPL), quantum molecular resonance (QMR), or other procedure to treat DED within the previous 6 months.
5. intraocular surgery or laser ocular surgery within the previous 6 months.
6. use of topical antibiotics and anti-inflammatory treatments, including steroids and non-steroidal anti-inflammatory drugs.
7. systemic autoimmune diseases.
8. contact lens wearers.
9. pregnant or lactating women.
10. patients who did not understand or comprehend the informed consent.
Can Tranexamic Acid Reduce Bleeding After Post Partum Hemorrhage in Cesarean Section Delivery

The purpose of this study was to evaluate the effect of early administration of tranexamic acid (TXA) on post partum hemorrhage caused by uterine atony after cesarean section delivery.

This was a randomised, placebo controlled trial including 74 patients. The investigators included ASA1 parturients with correct haemostatic status undergoing cesarean section under spinal anesthesia. The randomization begins after the inefficacy of oxytocin injections and starting up sulprostone perfusion at the request of the surgeon. TXA Group received 10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours. Placebo Group received same volumes of normal saline. The investigators compared blood loss and transfusions in both groups.


Eligibility Criteria:
Inclusion Criteria:

* ASA1 parturients
* aged from 20 to 40
* correct preoperative haemostatic status (prothrombine ratio \> 60 % and platelet rate \> 100 000),
* cesarean section under spinal anesthesia complicated by uterine atony needing the introduction of Sulprostone

Exclusion Criteria:

* abnormal placentation
* severe pre-eclampsia
* coagulopathy and uterine rupture
* the contra indications of TXA : past history of vascular occlusive event, convulsion, and allergy.
The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination

This study aims to investigate the effect of providing additional information about possible mild side effects of the yellow fever vaccination on the reporting of physical symptoms. Additionally, the project aims to investigate the relationship between individual characteristics (trait anxiety and perceived sensitivity to medication) and the reporting of physical symptoms, as well as possible interactions between the level of information provided and individual characteristics. We hypothesize that more information about mild symptoms provided to participants will increase the number of reported symptoms after vaccination.


Eligibility Criteria:
Inclusion Criteria:

* Receiving yellow fever vaccination
* English speaker
* Aged over 18

Exclusion Criteria:

* No phone for follow-up
Risk Factors for AD-Associated Switch to Mania

The present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage.

Treatment of bipolar depression with antidepressants is strongly debated for the methodologically poor and insufficient data supporting their use and the widely held belief that antidepressants can induce new episodes of abnormal mood elevation or accelerate the rate of cycling. The present study aimed at identifying clinical risk factors for switch into (hypo)mania or mixed states, within 8 weeks after introduction of an antidepressant or after increasing its dosage, in a prospective, longitudinal design.

Eligibility Criteria:
Inclusion Criteria:

* Bipolar I and II disorder.

Exclusion Criteria:

* Major medical comorbidities.
MRI Study of the Gastric Insufflation After High-flow Nasal Oxygen (HFNO)

HFNO CAN BE USED AS A PREOXYGENATION TECHNIQUE BUT IS IT A SAFE TECHNIQUE IN TERMS OF GASTRIC INSUFFLATION?

The objective of this study is to evaluate by MRI whether the stomach is insufflated during HFNO use in healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Adults Volunteers

Exclusion Criteria:

* Pregnancy
* Claustrophobia
* Gastric surgery
* Gastric pathology