cyrilzakka/clinical-trials huggingface dataset:
Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients

This will be a prospective observational trial enrolling 20 patients with osseointegrated prostheses. Participants will be recruited from the orthopaedic outpatient clinic at Walter Reed National Military Medical Center in Bethesda, MD.

All eligible consenting patients will undergo daily stoma management per standard of care.

Patients will integrate antimicrobial photodynamic therapy into their stoma management program. The first treatment will take place in the orthopaedic clinic. All others will take place at home. Topical 5-ALA will be applied to the metal at the penetration site. After 2 hours, the light delivery device will be utilized and light will be administered for 15 minutes.

Data collection: After obtaining informed consent, study personnel will record injury-specific variables, surgery-specific variables, other variables related to their hospital course, demographic variables as well as comorbidities on the study case report forms (CRFs). They will obtain this information directly from the participant, from the participant's medical record, and the participant's treating orthopaedic surgeon or other health care providers. Baseline data collection points include participant characteristics and amputation details such as age, sex, comorbidities, highest education level achieved, social support, initial reason for amputation, type of amputation and all surgical dates. Study participants will be followed at 1 and 2 weeks after initiation of PDT treatment. To ensure research participant safety, serious adverse events (SAEs) will be documented and promptly submitted to the local IRB as per the required reporting processes.

Follow-up: Study participants will be followed at 1 week and 2 weeks.


Eligibility Criteria:
Inclusion Criteria:

* All patients with osseointegrated prostheses 18 years of age or older

Exclusion Criteria:

* Ongoing infection
* Pregnant
* Anticipated issues with compliance or follow-up
Dose-response of Ketamine in Patient Controlled Analgesia in Orthopaedic Surgery Patients

To study the multimodal protocol combining adjunct ketamine with oxycodone in intravenous patient-controlled analgesia bolus dosing and effects in patients scheduled for posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation


Eligibility Criteria:
Inclusion Criteria:

* 20 - 75 years of age
* Scheduled for elective posterolateral lumbar spine fusion with bilateral transpedicular screw instrumentation under general anaesthesia.
* Written informed consent from the participating patient

Exclusion Criteria:

* A previous history of intolerance to the study drug or related compounds and additives
* Concomitant drug therapy with opioids or strong CYP3A4 or CYP2B6 inductor(s) or inhibitor(s) 2 weeks prior to study.
* Patients younger than 20 years and older than 75 years.
* BMI \> 35, sleep apnoea, any other sleep disorder or condition that requires treatment with continuous positive airway pressure or automatic positive airway pressure device.
* Existing significant liver or kidney disease
* History of ischemic heart disease or conduction disturbance
* History of alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate informed consent
* Donation of blood for 4 weeks prior and during the study.
Autologous Serum Skin Testing in Patients With Atopic Dermatitis Autologous Serum Skin Testing in Patients With Atopic Dermatitis

Recently, IgE-type autoantibodies against self proteins have been detected in the serum of the atopic dermatitis patients. The role of this IgE autoantibodies involved in the pathogenesis of atopic dermatitis is not known, yet. But, there may be a correlation between the severity of the disease and the serum levels of this autoantibodies. The autologous serum skin testing is applied to both atopic dermatitis patients and healthy control and the results are estimated in this study.The investigators detected 70% positive autologous serum skin testing in atopic dermatitis patients and test positivity was higher in patients with atopy history, moderately severe disease calculated by SCORAD index and high serum IgE levels.


Eligibility Criteria:
Inclusion Criteria:

* Sixty AD patients and 30 healthy individuals

Exclusion Criteria:

* . The patients showing evidence of any other disease are not included to our study. No drug was allowed fourteen days prior to the test, including antihistamines and steroids.
Ultrasound-guided Continuous Low Serratus Anterior Plane Block in Hepatocellular Carcinoma Surgery

To investigate the clinical application of ultrasound-guided continuous low serratus anterior plane block in open surgery for hepatocellular carcinoma.

METHODS: Patients with hepatocellular carcinoma who attended our hospital from January 2021 to April 2023 were divided into CS group and N group according to the random number table method; CS group underwent ultrasound-guided continuous low anterior serratus plane block and N group underwent ultrasound-guided single anterior serratus plane block combined with rectus abdominis sheath block; the operation time, anesthesia time, incision length, sensory block time and sensory block maintenance time were counted and recorded. Pain score (NRS) was used to detect analgesia; alanine aminotransferase (ALT), liver function aspartate aminotransferase (AST), and prothrombin time (The time of thrombin, NRS) were measured by fluorescent quantitative PCR. （The time of thrombin (APTT), total bilirubin (TBIL) levels and adverse reactions.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-60 years;
2. ASAI-II;
3. BMI: 18-29 kg/m2

Exclusion Criteria:

1. Combined cardiac, cerebral, hepatic, and renal failure;
2. Comorbid psychiatric and neuromuscular disorders;
3. A history of allergy to anesthetic drugs;
4. Participation in other recent clinical or drug trials.
DSE vs. FFR in SCAD and BYSTANDER Lesions

Enrollment:

* Patients with stable coronary artery disease (SCAD) and moderate coronary artery stenoses (30-70 %)
* Patients with acute myocardial infarction and moderate stenosis of non-culprit arteries (NCL; BYSTANDER LESION)

Aims:

* To assess the diagnostic accuracy of dobutamine stress echocardiography (DSE) and invasive fractional flow reserve (FFR) measurement
* To assess the prognostic impact of reclassification by a mismatching negative test

Hypothesis:

* DSE and FFR have similar prognostic value in both clinical settings (SCAD and NCL)
* Considering the strong negative predictive value of both DSE and FFR, one negative test is sufficiently enough to defer revascularisation, even in the case of mismatch

Easy accessibility made fractional flow reserve (FFR) a widely accepted method to evaluate myocardial ischaemia in patients with moderate coronary artery stenosis, although the prognostic value for "hard" endpoints such as myocardial infarction and cardiovascular death is equivocal.

Dobutamine stress echocardiography (DSE) is a useful and safe non-invasive functional test for myocardial ichaemia evaluation. There are robust data confirming the prognostic value of DSE regarding the same "hard" endpoints.

In patients with SCAD there are clear recommendations in the recent guidelines both for DSE guided or FFR guided revascularization but the data about prognosis is limited, especially in the case of FFR guidance. The outcome is also equivocal if there is a difference between the invasive and non-invasive test result.

In patients with acute myocardial infarction, more than 50% of patients have multivessel disease. There are clear recommendations for the management of infarct related artery, however controversy still exists for the management of angiographically moderate NCLs.

In DSE vs. FFR prospective trial, the Investigators plan to perform both the DSE and FFR tests in the above mentioned clinical settings, to investigate the correlation between them. The causes of differences between them would be investigated as well as the prognostic impact of reclassification by a second test (either DSE or FFR).

If both tests are positive, revascularisation is planned to be performed (PCI Group). In cases of either double negative or mismatching tests, optimal medical therapy will be chosen (OMT Group) with clinical follow up of at least 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18 years
* Moderate Coronary Stenosis (30-70 %)
* Stable coronary artery disease or patients with acute myocardial infarction and at least one moderate non-culprit vessel stenosis

Exclusion Criteria:

* Left Main Coronary artery stenosis
* Age\>80 years
* Known non-cardiovascular disease with poor prognosis
* Patients for whom coronary angiography or stress echocardiography is contraindicated per institutional standard of care (e.g. History of severe and/or anaphylactic contrast reaction)
* Inability to provide informed consent;
* Inability to cooperate with the investigation
* Pregnancy
Artificial Intelligence for Learning Point-of-Care Ultrasound

Point-of care-ultrasonography has the potential to transform healthcare delivery through its diagnostic and therapeutic utility. Its use has become more widespread across a variety of clinical settings as more investigations have demonstrated its impact on patient care. This includes the use of point-of-care ultrasound by trainees, who are now utilizing this technology as part of their diagnostic assessments of patients. However, there are few studies that examine how efficiently trainees can learn point-of-care ultrasound and which training methods are more effective. The primary objective of this study is to assess whether artificial intelligence systems improve internal medicine interns' knowledge and image interpretation skills with point-of-care ultrasound. Participants shall be randomized to receive personal access to handheld ultrasound devices to be used for learning with artificial intelligence vs devices with no artificial intelligence. The primary outcome will assess their interpretive ability with ultrasound images/videos. Secondary outcomes will include rates of device usage and performance on quizzes.


Eligibility Criteria:
Inclusion Criteria:

* Internal medicine residents rotating on the general inpatient wards service.

Exclusion Criteria:

* Residents who had taken an ultrasound elective offered by our residency program
Optimisation of ECT Based on ASTI vs Narcotrend

The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (\>15sec), the sympathic response and the postictal EEG-suppression.

- Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. Standard treatment is to use Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric stimulation.

The aim of the study is to assess if timing of electric stimulation aiming for ar an anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than standard approach of using ASTI 1-2 minutes.

The Electro-Convulsion-Therapy (ECT) is a well accepted treatment option in severe depression. The quality of ECT is evaluated basing on minimal seizure duration (\>15sec), the sympathic response and the postictal EEG-suppression.

- Page 1 of 3 - For the treatment general anaesthesia is needed. On the other hand anaesthesia strongly influences the quality of the seizure. Standard treatment is to use Anaesthesia to intervention time (ASTI) of 1 to 2 minutes for ideal timing of the electric stimulation.

The aim of the study is to assess if timing of electric stimulation aiming for ar an anaesthesia depth of Narcotrend values 41-64 may provide better convulsion quality than standard approach of using ASTI 1-2 minutes.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3
* Age: 18 -90 years
* Signed informed consent
* Severe depressive disorder

Exclusion Criteria:

* ASA \>3
* Age \< 18 or \> 90
* denial of the patient
* Impossibility to fix Narcotrend electrodes
* Patients unable to consent
* Pregnancy
Risk Assessment for Progression to DMEK Following Cataract Surgery in Fuchs Endothelial Corneal Dystrophy

Justification. Fuchs' corneal endothelial dystrophy (FECD) is one of the main causes of corneal transplantation. In many cases, the corneal decompensation derived from this dystrophy is triggered as a consequence of cataract surgery, so the dilemma of facing isolated cataract surgery or combined with endothelial keratoplasty is often raised.

Objective. The present study aims to evaluate and select the most important predictive factors for corneal decompensation after cataract surgery in patients with FECD.

Method. Prospective observational study of the preoperative and intraoperative variables presumably associated with postoperative corneal edema requiring Descemet stripping endothelial keratoplasty (DMEK). Consecutive candidates for cataract surgery with FECD will be selected and anterior segment imaging will be performed, along with a complete ophthalmological examination. Clinical, pachymetric, tmographic, densitometric, specular microscopy, and intraoperative variables will be registered.


Eligibility Criteria:
Inclusion Criteria:

* FECD grade 2 or worse (modified Krachmer scale)
* Cataract requiring surgery
* Epithelial corneal edema evident in slit lamp examination

Exclusion Criteria:

* Concurrent anterior corneal dystrophy
* History of ocular trauma, ocular surgery, previous ocular inflammation or infection,uncotroled glaucoma, amblyopia, neovascular age-related macular degeneration, or active vacular retinal disease.
* Non-collaborative or unable to receive postoperative care at our institution.
The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Migraine

The purpose of this study is to investigate the safety and effectiveness of trigeminal nerve electrical stimulator on reducing the frequency of migraine onset. It is applied to migraine patients and analyzes the results by comparing them before and after 4weeks.

* Duration of study period (per participant): Screening period (-6\~0weeks), Intervention period (4weeks).
* Patient needs to visit site at least 3 times (Screening, Baseline, V4), V2 can be done with screening visit. V3 is tele-Visit.
* The clinical trial device performs a personal electrical stimulation around the trigeminal nerves for 4weeks (6 times/week), 20 minutes each time.
* During the study period, examination and treatment methods are carried out in the same way.

Eligibility Criteria:
Inclusion Criteria:

* Men and women over 19 years old
* Patients with migraine with or without migraine aura who meet ICHD-III (2018) diagnostic criteria 1.1 1.2
* Patients with history of migraine more than 1 year
* Patients who have headaches at least twice a month
* Those who do not take migraine prevention drugs from 12 weeks before screening to the end of the study, or who can maintain migraine prevention drugs during clinical trials without changing or adding additional migraine prevention drugs
* A person who voluntarily agreed to participate in this clinical trial

Exclusion Criteria:

* Those who are diagnosed with primary headaches (exception: low-frequency intermittent tension type headaches) and secondary headaches in addition to migraine headaches
* Those who are diagnosed with medication overuse headache in addition to migraine headaches
* Pregnant or lactating of women within 6months
* Among female subjects who are likely to be pregnant, those who disagree to contraception in a medically permitted manner during this clinical trial period. \*Medically permitted contraception: condom, Oral contraception that lasted for at least 3 months, contraceptive injection, contraceptive implant, intrauterine device, etc
* Patients with mental illness who can interfere with their participation in the study.
* In the case where medical devices for clinical trials cannot be applied due to being sensitive to orbital nerve stimulation.
* Patients with a history of drug or alcohol abuse
* Those who participated in other clinical trials within 30 days of screening.
Study of Endostar Combined With TP Regimen for Esophageal Cancer

a randomized controlled trial of endostar combined with TP regimen(liposomal paclitaxel-carboplatin) for chemoradiotherapy in esophageal squamous cell carcinoma(Ⅱ-Ⅲ)

This study was a controlled clinical trial.A total of 402 patients with pathologically confirmed esophageal squamous cell carcinoma would be enrolled.Patients were randomly divided into two group ,with 201 in the treatment group and 201 in the control group.The treatment group was treated with endostar,chemotherapy (liposomal paclitaxel-carboplatin)and concurrent radiotherapy.The control group was treated with chemotherapy (liposomal paclitaxel-carboplatin)and concurrent radiotherapy .The efficiency and safety would be evaluated. The objective response rate and progress free survival would be analyzed.This data of this study might provide a more effective treatment for esophageal squamous cell carcinoma

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 to 75 years;
2. Pathology confirmed as esophageal squamous cell carcinoma and Clinical stage is II-III;
3. Initial treatment, No surgery history;
4. ECOG 0\~2;
5. Expected survival \>=3 months;
6. All the patients should have target lesions that are measurable and evaluable;
7. Should be able to consume liquid diet, no esophageal perforation symptoms, no distant metastases;
8. The main organ function is normal, which meets the following criteria:

(1) The standard of blood test should be met (14 days without blood transfusion and blood products, no G-CSF and other hematopoietic stimulation factor correction): Hb\>=100g/L;ANC\>=1.5x10\^9/L;PLT\>=100x10\^9/L; (2) Biochemical inspection shall meet the following criteria: TBIL \< 1.5 ULN; ALT and AST \< 2.0 ULN.Serum Cr is less than 1.5 ULN or endogenous creatinine clearance rate \> 50 ml/min (the Cockcroft Gault formula); (3) Pulmonary function FEV1 \>=1 L or \>50% of corresponding value of normal people;

9. Female during the reproductive period should be ensured contraception during the study period; 10. Participants voluntarily joined the study, signed informed consent, and had good compliance and follow-up.

Exclusion Criteria:

1. Patients who do not meet the pathological type of the inclusion criteria and the primary site;
2. Allergic to recombinant endostar, carboplatin, paclitaxel, and contrast agents;
3. Have a distant metastasis;
4. The primary focal tumors or lymph node already had a surgical treatment (except for biopsy), chemoradiotherapy or targeted therapy;
5. Patient who suffered from other malignant tumor;
6. Subject with severe pulmonary and cardiopathic disease history;
7. Pregnant woman or Lactating Women and Women in productive age who refuse take contraception in observation period;
8. Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct;
9. Received other medicine trials in past 4 weeks;
10. Refuse or incapable to sign the informed consent form of participating this trial;
11. The researchers judged other conditions that could affect clinical research and the results of the study.
The Predictors of the Neonatal Hyperbilirubinemia

The oxygen tension increases more than 3 times from fetus to neonate. The oxidant stress happens. And it will cause the destruction of RBC. So, we propose that the ROS may play an important role of neonatal hyperbilirubinemia. There is strong association between the bilirubin level and ROS levels at 3 days old in our pilot study.

The incidence of neonatal jaundice is higher in Eastern population than western people. The bilirubin comes from the destruction of RBC which heme is released and catabolized. If the bilirubin enters into the brain and deposits in basal ganglion, it will cause apoptosis of the neuronal cells, that is so called kernictrus, which is the major complication of the neonatal jaundice. However, the bilirubin has its own antioxidant protective effect. Many clinical or basic studies tried to find out the relationship of bilirubin and reactive oxygen species (ROS) in recent years.

The American Association of Pediatrics proposed the management principle of neonatal jaundice in 1994. It postponed the management criteria of neonatal jaundice Besides, early discharge (before 48 hour-old) was the trend in many countries. It may be dangerous because the neonatal jaundice appears after 48 hour-old. Whether the criteria and the trend will cause the elevation of the incidence of kernictrus, is always the major concern of clinicians. So, searching factors to predict neonatal hyperbilirubinemia causes the interest of many investigators. The predictors are divided into risk-factor based and normogram based. But they are still not suitable for all populations.

Eligibility Criteria:
Inclusion Criteria:

* Health neonate

Exclusion Criteria:

* perinatal insults prematurity
Epi-GERD Study: Epidemiological Evaluation in Patients With Gastro-Esophageal Reflux Disease (GERD)

Cross-sectional epidemiological study in patients with diagnosis of GERD (Gastroesophageal Reflux Disease) and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor), in order to evaluate the persistence and / or relapse of symptoms of GERD.

OBJECTIVE: To carry out an evaluation about the persistence and / or relapse of symptoms in Colombian patients with diagnosis of GERD.

MATERIALS AND METHODS: A multicentric cross-sectional epidemiological study will be carried out in Colombian patients with diagnosis of GERD and with current treatment or with a history of recent treatment with some PPI (Proton Pump Inhibitor). The persistence and / or relapse of symptoms will be evaluated as the main variable. The secondary variables to be evaluated include: Demographical analysis, treatment (s) used by patients, adverse events associated with the treatments, comorbidities and risk factors. The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach, with a level of significance of 5%.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Previous diagnosis of Gastroesophageal Reflux Disease (GERD)
* CURRENT treatment with a proton-pump inhibitor (PPI), OR NOT CURRENT treatment with some PPI but YES in the last year

Exclusion Criteria:

* Refusal to participate in the study by the patient.
* Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer to the questions.
* Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.