cyrilzakka/clinical-trials huggingface dataset:
Prospective Validation of Pathology-based Artificial Intelligence Diagnostic Model for Lymph Node Metastasis in Prostate Cancer

The goal of this diagnostic test is to prospectively test the performance of pre-developed artificial intelligence (AI) diagnostic model for detecting pathological lymph node metastasis (LNM) of prostate cancer. Investigators had developed this AI model based on deep learning algorithms in preliminary research, and it performed well in retrospective tests.

Investigators will compare the diagnostic performance (sensitivity, specificity, etc.) of the AI model and routine pathological report issued by pathologists, to see if the AI model can improve the clinical workflow of pathological evaluation of LNM in prostate cancer in the real world.

Lymph node metastasis (LNM) is a common mode of metastasis in prostate cancer, and accurate postoperative pathological lymph node staging is of great significance for further treatment and prognosis assessment. However, the current pathological evaluation of lymph nodes relies on manual examination by pathologists, which has a relatively low diagnostic efficiency and is prone to missed-diagnosis for micro metastatic lesions. Therefore, investigators developed an AI diagnostic model for detecting pathological lymph node metastasis of prostate cancer based on deep learning algorithms in preliminary research, and it performed well in retrospective tests.

This study is a diagnostic test with no intervention measures, planning to collect pathological slides of formalin-fixed, paraffin-embedded lymph nodes resected from the enrolled patients and digitise them into whole-slide images (WSIs). The AI model will analyse the WSIs and generate pixel-level heatmaps and slide-level diagnostic results (with or without LNM). The routine pathological examination will be performed as usual. These two processes will not interfere with each other. And if there are inconsistency in slide-level classification between AI and routine pathological examination, investigators would convene senior pathologists for discussion to make the final decision (immunohistochemistry would be performed if necessary). The final result will be presented to the patient in the form of a pathological report.

Eligibility Criteria:
Inclusion Criteria:

* Patients with prostate cancer, undergoing radical prostatectomy and pelvic lymph node dissection.
* Patients with complete clinical and pathological information.

Exclusion Criteria:

* Patients with other tumors that metastasized to pelvic lymph nodes.
* The patient refused to participate in this diagnostic test.
Retrospective Study of Implants With Peri-implantitis Surgically Treated Using Enamel Matrix Derivative (EMD)

The existing records of a private practice limited to the practice of periodontology were reviewed to locate patients who had been diagnosed with peri-implantitis (failing dental implant) and had been surgically treated utilizing enamel matrix derivative (Commercially available FDA product Emdogain sold by Straumann USA). Various clinical factors were gathered from the existing records. Some of the factors recorded were: retention of the implant, presence of bleeding, presence of further damage, and presence of inflammation. All patients had signed an informed consent for treatment and the anonymous use of their data for research purposes. All HIPA requirements were followed.

See brief summary.

Eligibility Criteria:
Inclusion Criteria:

* all adult patients of record who presented with existing peri-implantitis that was clinically deemed treatable (the implant was not considered hopeless.)

Exclusion Criteria:

* none except for routine medical contraindications for periodontal surgery
Resting-State Functional MRI in Glioma Patients Before and After Surgery

This clinical trial studies how well resting-state functional magnetic resonance imaging (MRI) and cerebrovascular reactivity (CVR) MRI performed before and after surgery works in measuring the effects on language in patients with glioma. Mapping language function before brain tumor resection is crucial for preventing post-surgical deficits and maximizing restoration of language function following surgery. Additional imaging, such as resting-state functional MRI and CVR MRI, may help measure the language network in the brain before surgery and any effects on language function after surgery.

PRIMARY OBJECTIVES:

I. To develop a reliable platform for preoperative mapping of language networks using resting-state-functional magnetic resonance imaging (rs)-fMRI in glioma patients.

SECONDARY OBJECTIVES:

I. To explore the reorganizations of resting-state functional connectivity (FC) and their relation to neuropsychological outcomes in glioma patients after surgery.

OUTLINE:

Patients undergo standard of care functional (f)MRI, CVR MRI over 3 minutes, and rs-fMRI over 6 minutes 1 month before and within 6 weeks after standard of care surgery.

After completion of study, patients are followed up at 4-6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed brain mass suspected to be gliomas
* English speaker
* Right handed
* Tumor is located on or adjacent to Broca's or Wernicke's areas in the hemisphere suspected to be dominant for language
* No prior history of neurologic disease or insult, or neuropsychiatric illness requiring treatment that would affect cognition in the opinion of the attending neuropsychologist
* Patients who will undergo neurosurgical resection
* Patients who are on neurosurgical evaluation will undergo direct cortical stimulation (DCS) as standard of care
* Patients who will complete pre- and postoperative neuropsychological testing per standard of care
* Pregnant women

Exclusion Criteria:

* Patients with prior radiation or chemotherapy
* Patients cannot give informed consent
* Patients cannot undergo MRI and functional MRI examinations
MAST Trial: Multi-modal Analgesic Strategies in Trauma

This is a comparative effectiveness study of current pain management strategies in acutely injured trauma patients. Two different multi-modal, opioid minimizing analgesic strategies will be compared \[original multimodal pain regimen (MMPR) compared to multi-modal analgesic strategies for trauma (MAST) MMPR\].


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the trauma service who are 16 years and older.

Exclusion Criteria:

* pregnant
* prisoner
* patients placed in observation (i.e. not admitted to the hospital)
HIV Prevention and PrEP Intervention for SGM Adolescents and Parents: "Hey, Friend"

In this 24-month pilot study, we will conduct the preparation phase of a multiphase optimization strategy (MOST) to develop a culturally appropriate (for Deep South contexts, to be adolescent friendly, and to be acceptable to parents or guardians) modular HIV prevention mHealth intervention, targeting behavior change related to HIV testing, HIV prevention knowledge, and pre-exposure prophylaxis (PrEP) uptake for sexual and gender minority (SGM) adolescents, that can be seamlessly integrated into the existing school and community environments across the Deep South.

In this 24-month pilot study, we will conduct the preparation phase of a multiphase optimization strategy (MOST) to develop a culturally appropriate (for Deep South contexts, to be adolescent friendly, and to be acceptable to parents or guardians) modular HIV prevention mHealth intervention, targeting behavior change related to HIV testing, HIV prevention knowledge, and pre-exposure prophylaxis (PrEP) uptake for sexual and gender minority (SGM) adolescents, that can be seamlessly integrated into the existing school and community environments across the Deep South. To do so, in Aim 1, we will assess stakeholders' knowledge, sentiments, and beliefs related to HIV risk, HIV stigma, and HIV prevention including preferences related to modality of PrEP and PrEP acceptability. Then, in Aim 2, we will use Aim 1 data, applying the 4-step intervention mapping framework, to inform the development of intervention modules targeting 14-18 year old SGM adolescents (rationale for this age range presented later in this proposal). We will also, develop corollary modules for parents or guardians. After intervention modules have been finalized, in Aim 3, we will conduct a 4-arm randomization to assess each module's acceptability, feasibility, and clinical signal of effectiveness as compared to a time-attention control.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 14-18
* Parental or guardian consent
* SGM identity
* English speaking

Exclusion Criteria:

* Does not fit the inclusion criteria
to Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell)

To see the safety and efficacy of injecting MG4101 as a secondary treatment after curative liver resection on the patient with advanced HCC who has high risk of recurrence.

To see the safety and efficacy of injecting MG4101(Ex vivo expanded allogeneic NK cell) as a secondary treatment after curative liver resection on the patient with advanced HCC who has high risk of recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Under the age of 20 to 69 years of age
2. Child-pugh class A
3. After curative liver resection, diagnosed hepatocellular carcinoma
4. Modified UICC staging : stage 3
5. the women who is childbearing age, agree to maintain adequate contraception measure during clinical trial period.
6. Agreed to participate in this clinical trial, agree to the subject person or legal representative who agrees in writing

Exclusion Criteria:

1. Less than 20 years old, 70 years old or older
2. Metastasis of hepatocellular carcinoma with external parties surgery
3. who had Rupture of hepatocellular carcinoma (HCC)
4. Hepatocellular carcinoma treated with radiofrequency surgery therapeutics (Radiofrequency ablation, RFA), the carotid artery chemical embolization (Transarterial chemoembolization, TACE), underwent radiation therapy, such as topical therapeutics
5. suspected serious infection
6. Who have severe cardiovascular disease (coronary artery disease requiring treatment, heart failure, arrhythmias, myocardial infarction, etc.)
7. Pregnant, planning a pregnancy or breast-feeding women
8. Autoimmune Disease
9. Those who Latest within four weeks of administration of systemic steroids (However, inhalation, intranasal corticosteroids and topical administration of corticosteroids and short-time administration of a blood transfusion, if such reasons are excluded)
10. Latest within four weeks of taking immunosuppressive drugs such as Cyclosporine A
11. Within the last 5 years diagnosed with liver cancer and other malignancies
12. Investigator did not complete or the effectiveness or safety of pharmaceutical products of this clinical trial evaluation for any medical condition that can interfere with characters judged
Intraoperative Methylprednisolone and Sugammadex

Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses the effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows its activity by encapsulating these. Likewise, some other steroid hormones and drugs like flucloxacillin, toremifene, fusidic acid can also be effected. Thus, assuming that methylprednisolone would also be encapsulated by sugammadex and decrease its efficiency, in this study we aimed to compare the recovery times from recuronium-induced muscle relaxation after reversal with sugammadex between patients who receive intraoperative methylprednisolone or not.

After institutional review board (IRB) approval and informed consent, 100 patients will be enrolled in this prospective, single center, controlled study. Anaesthesia will be induced with propofol (3mg/kg) and rocuronium (0.6 mg/kg), followed by sevoflurane maintenance. Patients will be divided randomly into two groups methylprednisolone administered group and control group respectively). Neuromuscular blockade will be monitored using calibrated acceleromyography train-of-four (TOF WATCH SX Organon Ltd, Dublin, Ireland). Once rocuronium-induced neuromuscular blockade recovers spontaneously to TOF-count-two, all patients will receive 2.0 mg/kg of sugammadex. Neuromuscular monitoring will be continued until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time to recovery of TOF to 0.9 will be compared in both groups. The statistical analyses will be performed using Student T Test and Mann-Whitney U test.


Eligibility Criteria:
Inclusion Criteria:

* patient operated under general anesthesia and endothracheal intubation.
* 18-65 years old
* ASA II

Exclusion Criteria:

* Neuromuscular desease
* Renal desease
* Liver failure
* Hypersensitivity to the medications used in the study.
* Being on steroid medication
* Pregnanacy, Lactation
Longitudinal Changes in Serum KL-6 in IPF

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with a poor prognosis. More accurate tests to predict disease progression and response to treatment are required.

Krebs von den Lungen-6 (KL-6) is a blood marker associated with IPF. Results from previous studies have shown that levels of KL-6 are higher in patients with IPF compared to people without the disease. In addition, it is not clear what impact treatment has on KL-6 levels, and whether this could help us to monitor how effective treatment for IPF is.

The investigators plan to perform a study in which KL-6 levels in the blood of patients with a new diagnosis of IPF are measured at baseline, 3, 6 and 12 months to look for and changes in the levels of KL-6 in the blood.

Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease with a poor prognosis. Effective treatment which slows the progression of IPF has recently become available however, it is costly and at present is limited to patients who meet specific criteria based on their breathing tests. The breathing tests currently available to monitor progression of the disease are not always reliable and do not predict which patients will respond to treatment. More accurate tests to predict disease progression and response to treatment are required.

Krebs von den Lungen-6 (KL-6) is a blood marker associated with IPF. Results from previous studies have shown that levels of KL-6 are higher in patients with IPF compared to people without the disease. The majority of studies using KL-6 in IPF have taken place in Japan and there is limited evidence of how useful it is in a European population. In addition, it is not clear what impact treatment has on KL-6 levels, and whether this could help us to monitor how effective treatment for IPF is.

The investigators plan to perform a study in which KL-6 levels in the blood of patients with a new diagnosis of IPF are measured at baseline, 3, 6 and 12 months to look for and changes in the levels of KL-6 in the blood

The objective of this study is to assess changes in serum KL-6 levels in patients with IPF over a 12-month period and assess if this correlates with changes in lung function and if KL-6 levels change in response to treatment with antifibrotic therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Multi-disciplinary team (MDT) diagnosis of idiopathic pulmonary fibrosis as per international consensus guidelines

Exclusion criteria

* Significant respiratory co-morbidity (i.e. where the major respiratory diagnosis is not IPF)
* FEV1/FVC ratio \< 70% on full lung function testing
* Current smoker (within 4 week of enrollment)
* Received treatment for acute lower respiratory tract infection with last 4 weeks
* Use of long-term (greater than 4 weeks) oral corticosteroids or immunosuppression within 4 weeks of enrolment
* Current participation in a double-blind placebo-controlled pharmaceutical trial
Effects Of Food And Dose Regimen On The Antiviral Effects Of Maraviroc (UK-427,857) In Patients With Human Immunodeficiency Virus

To investigate the effects of food and dose regimen on the antiviral effects of Maraviroc (UK-427,857) in patients with human immunodeficiency virus (HIV)


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic HIV-1 infected male and female patients
* Weight between 50 and 100kg and within the permitted range for their height
* Patients with virus that targets CCR5 receptor

Exclusion Criteria:

* Patients with a CD4 count \<250 cells/mm3 or HIV viral load \<5000 copies/mL
* Patients whose HIV infection has been diagnosed less than 3 months prior to screening, or for who there is evidence of recent seroconversion
* Patients with acquired immunodeficiency syndrome (AIDS) or a previous AIDS diagnosis
* Patients who are taking or have taken antiretroviral drugs in the eight weeks prior to the study screening visit
Safety and Efficacy of Sustained Interferon Alfa 2b (INF) Therapy of Relapsing Hepatitis C (HCV) Patients Using InfraDure Biopump

Patients who completed the conventional treatment against HCV and relapsed (the virus appeared again in their blood) have no effective therapy.

The rational behind the proposed study is that most patients can not tolerate the prolonged IFN injections because the side effects. The new proposed treatments allows continous low doses of IFN to be secreted by the patients himself using his own skin in which the dermo fibroblasts are enriched by a human gene of erythropoietin. The "biopump" continues to secret the IFN for several months avoiding the spikes of IFN in the plasma which are beleived to cause the undesired effects.

Patients will be able to complete a long treatment with low IFN dose and Ribavirin hoping to induce prolonged remission and cure

Eligibility Criteria:
Inclusion Criteria:

* Signed patient consent form
* Chronic HCV patients in relapse following conventional treatment regimen (INF+Ribavirine) with detectable plasma level of HCV RNA
* Hepatitis B and human immunodeficiency virus negative at screening visit
* Able and willing to follow contraception requirements
* Screening laboratory values, test, and physical exam within acceptable range

Exclusion Criteria:

* Current enrollment in another investigational device or drug study
* Anticipated inability to complete all clinic visits and comply with study procedures
* History of, or any current medical condition, which could impact the safety of the subject during the study
* Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
* Alcoholism or substance abuse with \<6 documented months of sobriety
* Known allergy or sensitivity to interferons or ribavirin
* Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries

Brain Entrainment Technology (BET), also known as Binaural Beat Technology (BBT); is an auditory-neurophysiologic technique which uses auditory tones (often embedded in music, nature sounds or white noise) dichotically via stereo headphones to manipulate brainwave activity in turn affecting the listener's mental, physical and/or emotional state. Although this technology is widely marketed to the general public and can be found free in on the internet, only a hand full of scientific studies have shown its efficacy. This study is a follow-on study to the "Sound Mind Warrior (SMW) Study" (ClinicalTrials.gov \[NCT02328690\]) conducted 2012-2015 which assessed the efficacy of the technology (in the "theta" brainwave frequency) on the cardiovascular stress response in a group of service members with complaint of chronic stress. This study will now assess BET (in the "delta" brainwave frequency) on sleep quality in a population of military healthcare beneficiaries with complaint of poor sleep quality.

This study will follow a prospective, one group pre- and post-intervention design.

A sample of 162 military healthcare beneficiaries (within the Kaiserslautern Military Community footprint) with complaints of poor sleep quality will be instructed to wear sleep actigraphy monitors and complete daily sleep diaries upon waking for a total of four weeks. On weeks 3 and 4, participants will use BET at bedtime for a minimum of 30 minutes. Pre and post sleep quality measures will be compared along with pre- and post- c-reactive protein (CRP) measures and a post-study questionnaire to assess participants' perception about the technology.

Eligibility Criteria:
Inclusion Criteria:

* Score greater than or equal to 15 on the Insomnia Severity Index (ISI)
* Affiliated with at least one of the 13 installations within the Kaiserslautern Military Community (KMC) area
* Eligible to receive healthcare at Landstuhl Regional Medical Center (LRMC)
* Are 18 years or older
* Can read and speak English
* Are able to commit to a 4 week study

Exclusion Criteria:

* Are taking any type of medication that causes drowsiness
* Have been diagnosed with moderate to severe traumatic brain injury (TBI)
* Have a history of epilepsy
* Are taking any medication in the anti-seizure category
* Have been diagnosed with, taking medication for, or are currently being evaluated for a psychological health issue as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) that will prohibit them from using intervention as perscribed.
* Have ear trauma, difficulty hearing or wear a hearing aide
* Have a chronic inflammatory health issue
* Are pregnant or are trying to become pregnant in the next 4 weeks

  \*Women of child bearing age will be asked to provide a urine sample for a pregnancy test
* Are currently using BET
Valganciclovir for Treatment of Cytomegalovirus Infection in Solid Organ Transplant Patients

The objectives of this study were:

1. To demonstrate the efficacy/safety of a short therapeutic strategy of treatment of CMV infection/disease in SOT patients (kidney, liver and heart recipients) based on 21 days of treatment.
2. To compare the exposure to ganciclovir, at steady state, after oral valganciclovir with respect to ganciclovir given intravenously (i.v.).
3. Evaluate the security of this treatment with valganciclovir.

SOT recipients (kidney, liver and heart transplant) presenting CMV infection or disease were eligible for inclusion if they were ≥18 years of age and presented a positive CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC). Patients excluded were those with severe CMV tissue invasive disease, unable to receive oral medication, absolute neutrophil counts less than 500/ mm3, platelets \<25000 platelets/mm3, Hemoglobin\< 80g/l or estimated glomerular filtration rate\< 10 mL/min (according to the Cockcroft-Gault formula).

Patients received a short induction treatment with ganciclovir i.v (Cymevene®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at the dose of 5 mg/kg/12h, by a peripherical vein infusion of one hour, during 5 days followed by treatment with oral valganciclovir (Valcyte®; F. Hoffmann-La Roche Ltd, Basel, Switzerland) at 900 mg/12h during 16 days, after meals, until complete a total of 21 days of treatment. In patients with impaired renal function ganciclovir i.v. and oral valganciclovir doses were adjusted at each visit according to estimated Glomerular Filtration Rate (GFR) by Cockcroft-Gault equation, as recommended by the manufacturer.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age, solid organ transplant recipients.
* presented a CMV infection demonstrated by CMV antigenemia (pp65) defined as ≥ 20positive cells/105 peripherical blood mononuclear cells (PBMC).
* gave written informed consent.

Exclusion Criteria:

* HIV patients.
* Multiorganic transplant.
* Severe CMV tissue invasive disease.
* Unable to receive oral medication.
* absolute neutrophil counts less than 500/ mm3.
* Platelets \<25000 platelets/mm3.
* Hemoglobin\< 80g/l.
* Estimated glomerular filtration rate\< 10 mL/min (according to the Cockcroft-Gault formula)