cyrilzakka/clinical-trials huggingface dataset:
Artificial Intelligence-based Prediction of Radio-cephalic Arteriovenous Fistula Maturation Using Preoperative Duplex Examination

The goal of this observational study is to assess the efficacy of AI-driven models in analyzing comprehensive ultrasonographic variables across multiple forearm locations to predict successful AVF maturation. The main question it aims to answer is:

Can AI-driven models analyzing comprehensive ultrasonographic variables accurately predict the successful maturation of arteriovenous fistulas (AVFs)?

Participants who underwent radiocephalic arteriovenous fistula (AVF) creation had their preoperative ultrasonographic data analyzed using AI-driven models to predict successful AVF maturation over a four-year retrospective period.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent RCAVF due to advanced chronic kidney disease from 2018 to 2022

Exclusion Criteria:

* Patients who did not have follow-up data available
Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed choroidal melanoma undergoing proton therapy
* Tumors \>15 mm in largest diameter and/or \>5 mm in height
* Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye

Exclusion Criteria:

* History of prior treatment for choroidal melanoma
* Pregnancy or lactation
* Presence of diabetic retinopathy
* History of retinal vascular occlusion or other retinal vascular disease
* Active ocular inflammation or history of uveitis in either eye
* History of uncontrolled glaucoma (defined as intraocular pressure \>30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
* Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days.
* Concurrent use of systemic anti-VEGF therapy
Jumping Gap Dimension at Maxillary Teeth: Cone-Beam Computed Tomography (CBCT) Study

To assess the important anatomical structures involved in the treatment planning of immediate implants, particularly the jumping gap distance at the different maxillary teeth in the esthetic zone using CBCT analysis. Additional relevant radiographic aspects are evaluated as well to aid in decision making related to immediate implants.


Eligibility Criteria:
Inclusion Criteria:

* teeth at upper jaw including : incisors, laterals, canines and premolars

Exclusion Criteria:

* teeth having: extensive restorations, crowns, implants
* CBCT scans showing scattering
* teeth showing bone loss around them indicative of periodontal disease
Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis

TRK-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by selectively suppressing the expression of transforming growth factor-beta 1 (TGF-β1) protein, at the gene expression level. This study is a double-blind, randomized, placebo-controlled Phase I study. The primary objective of the study is to assess the safety and tolerability of single and multiple inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis (IPF).


Eligibility Criteria:
Inclusion Criteria:

* Clinical, radiographic, and histologic features consistent with the diagnosis of IPF
* SpO2 ≥90% at rest by pulse oximetry while breathing ambient air.
* FVC ≥50% of predicted.
* FEV1 ≥50% of predicted.
* Ratio of FEV1 to FVC ≥0.7.
* DLCO corrected for hemoglobin 30% to 79% of predicted, inclusive.

Exclusion Criteria:

* History of acute exacerbation of IPF or respiratory tract infection within 3 months prior to Screening.
* Planned surgery during the study.
* History of malignant tumor within 5 years prior to Screening.
* History of emphysema or clinically significant respiratory diseases (other than IPF).
* Other known causes of interstitial lung disease (eg, drug toxicities, environmental exposures, connective tissue diseases).
* End-stage fibrotic disease expected to require organ transplantation within 6 months.
* Taking a systemic corticosteroid, cytotoxic therapy, vasodilator therapy for pulmonary hypertension, or unapproved treatment for IPF within 4 weeks prior to Screening. (Treatment with pirfenidone or nintedanib, though not both concurrently, is permitted, provided that the subject has been on a stable dose for at least 4 weeks prior to Screening and it is anticipated the dose will remain unchanged throughout enrollment.)
PRECEDE-PROCEED Model-based Program on Genital Hygiene Behaviors

The study was conducted to investigate the effect of a training program based on the PRECEDE-PROCEED Model on improving genital hygiene behaviors.It was carried out using experimental research design with pre-test and post-test, randomized and a control group. The study was conducted at Erzurum Saltuklu Family Health Center between June 2017 and January 2018. Of the women with genital infections, 120 women were included in the study, of which 60 were in the experimental group and 60 were in the control group. The data were collected by "Personal Information Form," "Genital Hygiene Knowledge, Attitude and Beliefs, Questionnaire" and "Genital Hygiene Behavior Inventory". In study, genital hygiene training intervention prepared according to the Precede-Proceed model was applied to the women in the experimental group. The women in the experimental group were measured at three different times: pre-test before training, post-test through training completition, and follow-up test after 4 weeks. The women in the control group did not receive any training intervention, the pre-test at the first encounter in the family health center and the post-test 5 weeks later.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-49,
* married,
* At least primary school graduate,
* No mental and communication problems,
* No chronic disease,
* Non-pregnant.

Exclusion Criteria:

* Women who have entered menopause,
* Women who had received any training on genital hygiene before
AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)

AcQMap Registry is an observation study

AcQMap Registry is an observational, prospective, multi-center, open-label registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic AcQMap System.

Eligibility Criteria:
Inclusion Criteria:

Male or female 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.

Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.

Willing and able to give written informed consent.

Exclusion Criteria:

In the opinion of the Investigator, any known contraindications to an ablation procedure.

Current enrollment in any study protocol sponsored by Acutus Medical. Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).
A Study on Factors of Biochemical Response in Autoimmune Hepatitis

The goal of this observational study is to clarify the clinical characteristics of autoimmune hepatitis (AIH) in China. The main questions it aims to answer are:

Human leukocyte antigen (HLA) gene susceptibility in Chinese AIH patients prognostic factors associated with AIH Participants will provide liver tests results and details of treatment during follow-up.

This study aims to establish a high-quality, standardized prospective cohort of AIH with regular follow-up, clarify the clinical characteristics of AIH in China, construct a prognostic model, and explore new serum markers or AIH gene susceptibility, so as to provide key clinical evidence for the prevention and treatment of AIH in China.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old at the time of onset;
2. AIH simplified score ≥6 and/or AIH revised score ≥10;
3. Liver biopsy was performed and consistent with the pathological diagnosis of AIH;
4. Patents were treatment naive or who were diagnosed and treated in other hospitals but have stopped glucocorticoid/immunosuppressive therapy for more than 3 months;
5. Agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. concomitant liver diseases: hepatotropic viral hepatitis (A, B, C, D, and E) and non-hepatotropic viral hepatitis (cytomegalovirus and Epstein-Barr virus (EBV) infection);
2. concomitant with drug-induced liver injury, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease, genetic and metabolic liver diseases;
3. bone marrow or liver transplantation;
4. incomplete baseline medical history and laboratory examination results;
5. for previously diagnosed patients, immunosuppressive therapy was discontinued less than 3 months;
6. Pregnancy or lactation;
7. patients with contraindications to glucocorticoid/immunosuppressive therapy;
8. complicated with other malignant tumors;
9. complicated with mental disorders.
Post Marketing Clinical Follow Up of the BioProtect Balloon Implant System

Long-Term Prospective Post Marketing Clinical Follow Up for Evaluation of the BioProtect Balloon Implant™ System

Multi-center, long-term, prospective, observational study for assessment of late rectal toxicity and quality of life in prostate cancer subjects undergoing radiotherapy by means of IMRT following implantation of the BioProtect Balloon Implant System.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has previously participated in the BP-007 clinical study and completed their IMRT treatment.
2. Subject agrees to complete all required follow-up visits.
3. Subject provides written Informed Consent prior to any study related procedure

Exclusion Criteria:

1. Subject who completed 48 months of follow-up in the BP-007 study.
2. Subjects who are receiving at the time of the study, any other investigational agents/ devices.
3. Subjects unwilling and/or unable to comply with the provisions of the study protocol.
Performance Evaluation of a Non-Invasive Glucose Monitor as Compared to CGM Data Acquired by the iPro2

This study is for adults and adolescents with type 1 diabetes. The purpose of this study is to learn more about an investigational system to measure blood glucose. This system does not require blood to be drawn from the body, and it does not require a glucose sensor to be worn under the skin (subcutaneously). This device instead estimates blood glucose levels by shining infrared light on the skin and then using sophisticated statistical analysis on how the light bounces back or gets absorbed (spectral data). The researchers in this study will compare the accuracy of the new device to glucose measurement devices that are already approved by the FDA, including glucose meters and subcutaneous continuous glucose monitoring (CGM) sensors. Information learned from this study will be used in the development of tools for managing diabetes.

The purpose of the study is to evaluate the utility of a novel approach to non-invasive glucose sensing. The testing for each patient includes fingerstick and alternate site capillary blood measurements taken nearly simultaneously with a series of near-infrared spectra collected via a novel, proprietary fiber-optic probe. Simultaneously, subjects will be wearing a commercial continuous glucose measuring system (Medtronic iPro 2). The spectral data are converted to a prediction of tissue glucose using a proprietary pre-defined universal algorithm. Subjects are tested every 20 minutes for up to 12 hours per day and up to 6 visits per patient over a period of up to 4 months.

Eligibility Criteria:
Inclusion Criteria:

* Are between the ages of 12-75 years
* Have been diagnosed with type 1 diabetes mellitus
* Use insulin to treat your diabetes
* Agree and are able to follow the study plans as described in this informed consent form.

Exclusion Criteria:

* Are a pregnant woman or nursing mother
* Have skin conditions that could cause a problem wearing a glucose sensor on your abdomen (stomach area) and/or having spectral data measured from your forearm with the non-invasive device.
* Are currently taking part in another clinical study
* Have taken part in this study before
* Have experienced severe hypoglycemia (an episode of low blood sugar that you were unable to treat yourself - e.g., seizure, coma, unconsciousness) any time within the past six months
* Have any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent you from completing the study
Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets

The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for implantation of a pacemaker or ICD in the deltopectoral region at Mayo Clinic Hospital in Phoenix.

Exclusion Criteria:

* Allergy to one of the closure materials.
A Study of Cetrelimab in Participants With Chronic Hepatitis B Virus Infection

The purpose of the study is to characterize the pharmacokinetic (PK) profile of cetrelimab administered subcutaneous (SC) and optionally intravenous (IV) in chronic hepatitis B (CHB) participants.

Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver and can cause either acute (less than 6 months) or chronic (more than 6 months) infection. Persistence of HBV infection requires antigen-specific immune tolerance that prevents clearance of infected cells. Cetrelimab (JNJ-63723283) is a fully human immunoglobulin (Ig) G4 kappa monoclonal antibody (mAb) that binds to programmed cell death receptor-1 (PD-1) with high affinity and specificity. PD-(L)1 inhibitors could possibly reverse the immune dysfunction from HBV. The study will be conducted in 3 phases: a screening phase (6 weeks), a single dose intervention phase (1 day), and a 24-week follow-up phase. The duration of individual participation will be up to 30 weeks. Key safety assessments include monitoring of Adverse Events (AEs), physical examination, vital signs, Electrocardiogram (ECGs), Injection site reaction (ISRs), Infusion-related reaction (IRRs), and clinical laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Must have chronic hepatitis B virus (HBV) infection documented
* Participants should be virologically suppressed, Hepatitis Be antigen (HBeAg) status (positive or negative) be on stable Nucleotide analog (NA) treatment for at least 6 months
* Must have: a) A liver biopsy result classified as Metavir F0-F2 within 2 years prior to screening; b) If a liver biopsy result is not available: Fibroscan liver stiffness measurement less than or equal to (\<=) to 9.0 kilopascals (kPa) within 6 months prior to screening or at the time of screening
* Must be medically stable
* Must have a body mass index (weight in kilogram \[kg\] divided by the square of height in meters) between 18.0 and 30.0 kilograms per meter square (kg/m\^2), extremes included

Exclusion Criteria

* History or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices
* Participants with evidence of liver disease of non-HBV etiology.
* Participants with history or signs of cirrhosis or portal hypertension (nodules, no smooth liver contour, no normal portal vein, spleen size greater than or equal to \[\>=\] 12 centimeters) or signs of hepatocellular carcinoma (HCC) on an abdominal ultrasound performed within 6 months prior to screening or at the time of screening
* History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
Tandem High Dose Chemotherapy and Autologous Stem Cell Rescue for High Risk Pediatric Brain Tumors

The investigators plan to improve event free survival rate and reduce treatment related toxicities of pediatric patients with high risk/recurrent CNS tumors by administrating tandem high dose chemotherapy and autologous stem cell rescue.

High risk/recurrent central nervous system (CNS) tumors have a poor prognosis so that tandem high dose chemotherapy (HDCT) with hematopoietic progenitor stem cell rescues has been chosen as potentially curative therapy. Many institutions have used carboplatin, thiotepa, etoposide (CTE) for conditioning regimen of 1st HDCT and cyclophosphamide, melphalan (CM) for conditioning regimen of 2nd HDCT. Our institution applied this regimen to the 38 pediatric patients with high risk brain tumor since 1996. Although the 3 year overall survival rate and event free survival rate were improved to 69% and 47.9%, respectively, the results showed relatively high treatment related mortality (TRM) rate of 21%. Toxicity of this tandem regimen was also reported as being high up to 32% in other researches as well so that this regimen is considered not feasible due to toxicity. In this study, the investigators plan to improve event free survival rate and reduce treatment related toxicities of pediatric patients with high risk/recurrent CNS tumors by administrating tandem high dose chemotherapy and autologous stem cell rescue with topotecan, thiotepa, carboplatin (TTC) for 1st HDCT and melphalan, etoposide, carboplatin (MEC) for 2nd HDCT.

Eligibility Criteria:
Inclusion Criteria:

1. High risk pediatric brain tumors Newly diagnosed medulloblastoma, CNS PNET, ATRT, Choroid plexus carcinoma, pineoblastoma with residual tumor over 1.5cm2 after operation or with leptomeningeal seeding at diagnosis
2. All high grade or malignant brain tumor, age \< 3 years
3. Recurrent embryonal brain tumors, recurrent CNS germ cell tumor
4. Age : no limitation
5. Performance status : ECOG 0-2.
6. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases.

   Heart: a shortening fraction ≥ 28%. Liver: total bilirubin \< 2 ⅹ upper limit of normal; ALT \< 3 ⅹ upper limit of normal. Kidney: creatinine \< 2 ⅹ normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
7. Patients must lack any active viral infections or active fungal infection.
8. Patients (or one of parents if patients age \< 20) should sign informed.

Exclusion Criteria:

1. Patients who do not reach partial response prior to high dose chemotherapy.
2. Pregnant or nursing women.
3. Malignant (except brain tumor) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
4. Psychiatric disorder that would preclude compliance.
5. Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
Circadian Rhythm and Attack-timing in Episodic Cluster Headache Patients in- and Outside of Bout: an Actigraphic Study

The aim is to investigate circadian rhythm in episodic cluster headache using actigraphy.

The aim is to investigate circadian rhythm in episodic cluster headache patients in- and outside of bout. This will be done using actigraphy and a short diary for 2 weeks in each period. A secondary outcome is to look at attack occurence and physical activity before and during an attack.

Eligibility Criteria:
PATIENTS

Inclusion Criteria:

* Age between 18 and 65 years of age
* Episodic cluster headache
* The patient can differentiate cluster headache from other primary headaches if he suffers from any.

Exclusion Criteria:

* Circumstances, determined by the PI, that makes the patient ineligible.
* Changes in preventive medication within 7 days before the study initiation and during the 2 weeks.
* Changes in antidepressive medication or antipsychotic medication within 2 weeks before the study initiation and during the 2 weeks.
* Serious somatic and/or psychiatric disorders
* Alcohol intake \> 50 units pr.week
* Pregnancy / breastfeeding
* Patient cannot accept the conditions of the trial
* Patient does not understand Danish.

CONTROLS

Inclusion Criteria:

- Age between 18 and 65 years of age

Exclusion Criteria:

* Circumstances, determined by the PI, that makes the patient ineligible.
* Any primary headache more than 1 day / month
* Diagnosed with a secondary headache
* Treatment with antidepressive medication or antipsychotic medication within 2 weeks before the study initiation and during the 2 weeks.
* Serious somatic and/or psychiatric disorders
* Alcohol intake \> 14 / 7 units pr.week (males / females)
* Pregnancy / breastfeeding
* Patient cannot accept the conditions of the trial
* Patient does not understand Danish.
A Retrospective Study Reveals the Relationship Between gp42-IgG Epitopes and EBV-associated NPC

Epstein-barr virus (EBV) infection is a necessary factor of nasopharyngeal carcinoma (NPC). The incidence of NPC in endemic regions reaches 24.60/100,000 people, far higher than that of the worldwide average. However, no EBV prophylactic vaccines is clinically available so far, which is largely hampered by the difficulties in selecting optimal vaccine design target out of 13 glycoproteins on the surface of EBV. In this study, we utilized humanized gp42-IgG antibodies to explore the dominant epitopes of gp42, one of the functional EBV glycoproteins during virus entry, to facilitate prophylactic vaccine design.


Eligibility Criteria:
Inclusion Criteria:

* Controls underwent physical examinations or primary NPC cases confirmed by pathology or cytology.
* If cases, at stage I-IVB diagnosed by radiology according to AJCC/UICC 8th.
* If cases, Karnofsky score (KFS)≥70, estimated survival span\>12 months.
* If cases, no disordered of major organs is found; blood test, liver, and kidney functions are basically normal.
* If cases, at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1.

Exclusion Criteria:

* History of other malignant diseases.
* History of severe systemic diseases or heart, lung, liver, or kidney disfunction.
* History of severe neurological, metal, endocrine diseases.
* History of HBV, HCV, HIV, TP, or TB infection.
* If controls, physical examination reveals systemic diseases including malignant diseases.
* If cases, incomplete blood and pathological sample data.
* If cases, not receiving primary treatment in this facility.
* Other individuals investigators find not suitable for the trial.