cyrilzakka/clinical-trials huggingface dataset:
Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Guided Biopsy in Men With Elevated PSA

In 22% of patients with elevated Prostate-specific antigen (PSA) MRI guided biopsy will not detect significant prostate cancer (PCA) (defined as either: Gleason score (GS) ≥ 3+4 or tertiary pattern 5, or final stage ≥ pT3a and/or pN1). Therefore this study evaluates the ability of \[68Ga\]PSMA PET/MRI to detect and localize significant primary PCA to accurately direct prostate needle biopsy using the Gleason score from the histology of the core biopsies as standard of truth.

In this open label, single center, non-randomized, diagnostic study we plan to include 40 men with elevated PSA (ages 30-50 PSA \>2.5 ng/mL; ages 50-80 PSA \> 4ng/mL), which are assigned to a MRI guided biopsy.

These patients will undergo one additional PET/MRI scan with \[68Ga\]PSMA within two to three weeks before the biopsy (Arm A), or in case of an unclear/negative MRI scan but positive biopsy two to three weeks after biopsy (Arm B). In Arm A a radiologist will delineate the suspected areas on (A) multiparametric magnetic resonance image (mpMRI) and a nuclear medicine physician will delineate and color code the suspicious areas on the PET/MRI: (B) \[68Ga\]PSMA. The images will be loaded into the BiopSee® system. Lesions positive on both modalities will be labeled as "AB". Every suspicious lesion will be targeted with 3 cores. A maximum of 3 targets will be selected per patient.

For arm B: PET/MRI results will be correlated with the template biopsy results.

The data analysis of Arm A and Arm B will be identical. For the analysis the Gleason score from the histology of the core biopsies will serve as standard of truth.

After completion of the PET/MR study part - an amendment for PET/CT was submitted to the local ethics commity and acknowledged to include 10 more participants with PSMA PET/CT to investigate the use of PET/CT guided biopsy and intraoperative verivication of the target with a gamma counter.

Eligibility Criteria:
Inclusion Criteria:

1. Previously undiagnosed patients with elevated PSA (ages 30-50 PSA \>2.5 ng/mL; ages 50-80 PSA \> 4ng/mL), eligible for prostate needle biopsy.
2. Patients can have negative prior needle biopsy(ies) for suspected prostate cancer
3. mpMRI with at least one suspicious target lesion (Arm A), or negative mpMRI but positive biopsy (Arm B).
4. Written informed consent
5. Age \> 30

Exclusion Criteria:

1. Age\> 80
2. Contraindication to MRI or prostate biopsy (e.g. extreme claustrophobia, metallic implants incompatible with MRI, anatomical contraindications, coagulopathy, severe medical comorbidity prohibiting halting of anticoagulation therapies)
3. Active urinary tract infection or indwelling catheter
4. Prior pelvic irradiation
5. Prior prostatectomy
6. Prior androgen deprivation hormonal therapy
7. Prostate biopsy within 8 weeks prior to study
8. Prior transurethral resection of the prostate (TURP)
Unravelling the Role of KCTD Protein Family in the Clinical Management of Childhood Acute Lymphoblastic Leukemias

A transcriptomic analysis of bone marrow from B-ALL patients was performed by our research group for identifying novel protein/factor with a putative role of disease biomarker. Along with some already known B-ALL biomarkers, our analysis highlighted deregulation of some members of an emerging protein class denoted as KCTD (Potassium ChannelTetramerization Domain-containing proteins). Starting from our preliminary observations, and considering that KCTDs havenever been studied in ALL, we decided to study these proteins in B- and T-ALL affected pediatric patients, enrolled by our research group in collaboration with AORN Santobono-Pausilipon pediatric oncological hospital.Indeed, the present research program aims at opening a new scenario for the study of KCTD proteins in childhood leukemias. The final goal of the project will be to evaluate the translational relevance of selected deregulated KCTDs as novel biomarkers useful for B-ALL and T-ALL diagnostics, and patient management.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 1-18 years of both sexes diagnosed with B- ALL and T-ALL;
* Patients who will have signed the informed consent

Exclusion Criteria:

* Patients who refuse to participate in the study;
* Patients who do not fall within the age range mentioned above
Intervention Development and Pilot Study to Prevent Untreated Native Hawaiian and Pacific Islander Opioid Use Disorder

This study will design and pilot/feasibility test a culturally grounded intervention to increase the treatment seeking of Pacific Islanders with opioid use disorders in formal services.

For the clinical trial arm of this pilot/feasibility study, the investigators will conduct a pilot/feasibility test of our conceptual model of culturally grounded intervention components with 20 Pacific Islander adults with experience with opioid use disorders, then conduct 2 focus groups per site to finalize the components and items for larger R01 pilot and randomized wait-list controlled testing.

Eligibility Criteria:
Inclusion Criteria:

* Of Pacific Islander/Native Hawaiian or part-Pacific Islander/Native Hawaiian heritage.
* Live in Utah or Hawaii.
* For all lay Pacific Islander adult participants: must be over 18 years of age.
* Fluent (oral and reading) in English or Native Hawaiian.

For target Pacific Islander participants with OUDs, additional inclusion criteria is:

- Presence of active OUD, as screened via 8-item Rapid Opioid Dependence Scale.

Exclusion Criteria:

* Do not meet inclusion criteria,
* Are unwilling to participate,
* Fails to provide or retracts consent,
* Reside outside the target communities of Utah or Hawaii
Calypso Knee System Clinical Sub-study, OUS Continued Evaluation

Calypso Knee System Clinical Study, OUS for subjects with symptomatic osteoarthritis of the medial compartment of the knee. The sub-study will achieve continued evaluation of the safety and clinical effectiveness of the Calypso Knee System.

This sub-study will be a single-arm, prospective, multi-center sub-study for continued evaluation of the safety and clinical effectiveness of Calypso Knee System using an additional measure of post-operative activity improvement.

Eligibility Criteria:
Inclusion Criteria:

1. Participants age - 25 to 65 years
2. Body Mass Index (BMI) of \< 35, Weight \< 300 lbs
3. Knee osteoarthritis pain on the inner side of knee that has continued after at least 6 months of non-operative treatment

Exclusion Criteria:

1. Symptoms of osteoarthritis in the other knee or in lateral (outer) or patellofemoral compartments of the target knee
2. Knee ligament or meniscal instability
3. Other bone or joint conditions such as Rheumatoid arthritis, Paget's disease, Charcot's disease or general conditions such as allergy or hypersensitivity to certain metals, active infection, certain neurological conditions, use of medication such as steroids or chemotherapy that could impact study participation or results
Detection of Coronary Artery Calcifications by Whole Blood Transcriptome Analyzed by Artificial InTelligence Algorithms

The goal of this observational study is to determine the diagnostic accuracy of peripheral whole blood transcriptomes analyzed by an artificial intelligence algorithm to detect the presence and extent of coronary calcification in individuals without a history of known cardiovascular disease.

The main question it aims to answer is:

1. Will the proposed method predict the presence and extent of coronary artery calcification from the peripheral whole-blood transcriptomes?

This study will be a prospective observational single-site study. A convenience sample will be carried out to include 800 patients who attend the Clinic, to undergo a cardiac CT without contrast (coronary calcium score), either for a medical indication or volunteers for an assessment of cardiovascular risk. The study will have a baseline stage in which a clinical evaluation will be performed, blood samples will be drawn for transcriptome analysis and laboratory analysis. Then, a DNA sample obtained by swabbing the buccal mucosa will be taken. Subsequently, a non-contrast gated cardiac CT will be performed to assess the presence and extent of coronary calcification and other outcomes of interest. At the end of patient enrollment, biological samples will be sequenced for in silico evaluation of the results. Finally, a 5-year clinical (telephone) follow-up will be carried out to collect data on the incidence of fatal and non-fatal cardiovascular events.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 30 and 75 years attending the institution for a non-contrast cardiac CT scan (coronary calcium score) either by medical indication or voluntary for cardiovascular risk assessment.
* Signature of the informed consent form

Exclusion Criteria:

* Previously known chronic renal or hepatic insufficiency.
* Active chronic lung disease, defined as exacerbated asthma, exacerbated chronic obstructive pulmonary disease (COPD), or pulmonary fibrosis.
* Active and/or previous cardiovascular disease, defined as previous acute myocardial infarction, stable or unstable angina, cerebrovascular accident, history of vascular interventions (coronary or another territory), heart failure, severe cardiomyopathies, or valvulopathies.
* Uncontrolled hyper or hypothyroidism.
* Suprarenal insufficiency.
* Previous surgeries in the last 3 months.
* Severe trauma in the last 6 months, defined as one that involved bone fractures and/or surgical interventions.
* Known active cancer disease or under treatment (acute or preventive), or history of cancer disease without criteria for a cure.
* Known autoimmune disease active or in treatment.
* Ongoing pregnancy, postpartum period of fewer than 12 months, or breastfeeding.
* Other serious illnesses with an estimated life expectancy of fewer than 12 months (according to the investigators).
* Temperature greater than 37.5°C recorded by a thermometer or any acute infection caused by viruses or bacteria confirmed by a health professional in the previous 30 days.
* Pathologies under immunosuppressive treatment
Multimodal Analgesia With Interfascial Continuous Wound Infiltration: A Randomized Clinical Trial

Objectives: For major laparoscopic surgery, as with open surgery a multimodal analgesia plan can help control postoperative pain. Placing a wound catheter intraoperatively following colon surgery could optimize the control of acute pain with less consumption of opioids and few adverse effects.

Methods: We conducted a prospective, randomized, study of 103 patients scheduled to undergo laparoscopic colon surgery for cancer in Galdakao-Usansolo Hospital.

Patients were recruited and randomly allocated to wound catheter placement plus standard postoperative analgesia or standard postoperative analgesia alone. A physician from the acute pain management unit monitored all patients for at multiple points over the first 48 hours after surgery. The primary outcome variables were verbal numeric pain scale (NRS) scores and amount of intravenous morphine used via patient controlled infusion.


Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible for the study if they were aged 18 years or older, with an American Society of Anesthesiologists (ASA) 14 grade of I to IV (anaesthetic risk), were scheduled to undergo laparoscopic colon surgery, and voluntarily agreed to participate by signing an informed consent form.

Exclusion Criteria:

* Patients were excluded if they were allergic to amides or pyrazolones, were likely to require conversion to open surgery with laparotomy, were long-term users of opioids, required emergency surgery, were unable to participate due to cognitive deterioration, or declined to participate in the study.
Infraclavicular or Supraclavicular Brachial Plexus Blocks for Elbow Surgery

This study compares the infraclavicular approach to supraclavicular approach of brachial plexus block for elbow surgery.

Traditionally, infraclavicular as well as supraclavicular approaches to brachial plexus have been recommended for elbow surgery. Supraclavicular approach is considered to have a more rapid onset. However, investigators have noticed that the supraclavicular approach needs more supplementation if it is used for elbow surgery. Therefore more and more anesthesiologists now choose the infraclavicular approach for elbow surgery (though both approaches are recommended in the text books).

None of the published studies have addressed if one approach is indeed superior to the other specifically for elbow surgery. Therefore the investigators propose to undertake a study that will evaluate the two approaches to the brachial plexus specifically for elbow surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for ambulatory elbow surgery under block
* ASA 1-3

Exclusion Criteria:

* Narcotic dependent
* Severe systemic illness
* Refusal of block
* localized infection
The Association of Microbiota Composition With cGVHD After Allo-HSCT

Previous studies had found that the microbe in intestinal after allogeneic hematopoietic cell transplantation(allo-HSCT) were closely associated with overall survival and post-transplantation complications, especially graft versus host disease (GVHD).Due to the limited data on the association of microbiota composition with chronic GVHD(cGVHD) after allogeneic hematopoietic stem cell transplantation, the relationship between microbiota composition and post-transplantation complications, especially cGVHD, needs to be further evaluated.Detailed studies of the microbiome and host immune system will lead to the discovery of microbiome markers for early identification of patients at high risk for cGVHD. This may regulate patients' gut microbiota in an individualized manner to achieve optimal treatment outcomes while avoiding severe post-transplant cGVHD. We will operate a prospective, multicenter, nonrandomized, observational study. Patients will be asked to provide blood and stool samples during allo-HSCT.

Previous studies had found that the microbe in intestinal after allogeneic hematopoietic cell transplantation(allo-HSCT) were closely associated with overall survival and post-transplantation complications, especially graft versus host disease (GVHD).Due to the limited data on the association of microbiota composition with chronic GVHD(cGVHD) after allogeneic hematopoietic stem cell transplantation, the relationship between microbiota composition and post-transplantation complications, especially cGVHD, needs to be further evaluated.Detailed studies of the microbiome and host immune system will lead to the discovery of microbiome markers for early identification of patients at high risk for cGVHD. This may regulate patients' gut microbiota in an individualized manner to achieve optimal treatment outcomes while avoiding severe post-transplant cGVHD. We will operate a prospective, multicenter, nonrandomized, observational study. Patients will be asked to provide blood and stool samples during allo-HSCT. This blood will be used for plasma banking for further analysis, including miR, chemokine and metabonomics detection. Stool will be used for microbiome studies - isolation of total DNA/RNA and 16S rRNA gene sequencing for bacterial taxonomic classification. Furthermore, metagenomic sequencing and subsequent taxonomic and functional classification of microbial genes will be used.

Eligibility Criteria:
Inclusion Criteria:

1. aged between 18 years and 65 years
2. patients planned to be treated by allogeneic hematopoietic cell transplantation
3. signed written informed consent

Exclusion Criteria:

patients not-matching inclusion criteria
iPad Application to Treat Prosodic Deficits in Students With Communication Disorders

The purpose of this study is to evaluate the utility of a specialized iPad application designed to treat difficulties with intonation (e.g., melody in voice) in children with autism spectrum disorders (ASD) and other communication disorders.


Eligibility Criteria:
Inclusion Criteria:

* SLPs, in Connecticut Public Schools, who provide intervention to students with autism spectrum disorders and related disorders
* Students, ages 4-18, who attend school in Connecticut and demonstrate prosodic difficulties secondary to a diagnosis of ASD, apraxia of speech, or other communication disorder

Exclusion Criteria:

* Students with concomitant genetic disorders
A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Prostate Cancer

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).


Eligibility Criteria:
Inclusion Criteria:

* Part 1 A-G (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \[AAP\]): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram \[ng\]/milliliter (mL); Part 2H (apalutamide): (a) metastatic hormone-sensitive prostate cancer(mHSPC) with non-castrate levels of testosterone (greater than \[\>\] 150 ng/ deciliter \[dL\]) and a minimum PSA of 2 ng/milliliter \[mL\]; (b) Metastatic disease documented by greater than equal to (\>=) 1 bone lesion(s) on technetium-99m (99m\^Tc) bone scan. No definitive evidence of metastatic visceral disease
* Measurable or evaluable disease
* (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G and 2G (AAP)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant must not have received prior cytotoxic chemotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ functions

Exclusion Criteria:

* Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
* Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (\<=) 1 or baseline levels (except for alopecia, vitiligo, Grade \<=2 peripheral neuropathy)
* Solid organ or bone marrow transplantation
* Known allergies, or intolerance to any of the components (example, excipients) of JNJ-78278343, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E), darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G)
* Significant infections or serious lung, heart or other medical conditions
A Study to Evaluate SU-VEID™ for Improving Peripheral Venous Access Success in Children

The purpose of this study is to determine if use of the SU-VEID™ in children facilitates an increase success rate of peripheral intravenous starts, in comparison to the conventional method of vein entry techniques.


Eligibility Criteria:
Inclusion Criteria:

* Patient age \< 18 years old.
* Pediatric patients in surgical pre-op (0-18 years old), requiring an I.V. catheter for surgery who are difficult venous access.
* Written informed consent/ assent from the patient or legal guardian.

Exclusion Criteria:

- Patient age \> 18 years old.
Effects of Preoperative Frailty on Postoperative Recovery

This study aims to evaluate frailty using Short Physical Performance Battery (SPPB) before surgery and find out how frailty affects short-term postoperative recovery after surgery using Quality of Recovery-15 (QOR-15) questionnaire in patients undergoing minimally invasive distal gastrectomy for early gastric cancer.

As the elderly population increases, the evaluation and management of preoperative frailty is becoming important. In patients with frailty, exposure to external stress, such as surgery, can reduce physical function, increase postoperative complication, and raise the risk of death. This study aims to evaluate frailty using an automated device performing SPPB (Andantefit) and find out how frailty affects postoperative recovery.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 70 years of age, undergoing minimal invasive (laparoscopic, robot-assisted) distal gastrectomy for early gastric cancer, who can assess short-term postoperative recovery

Exclusion Criteria:

* Patients who have a difficulty in communication
* Patients who have a major medical or mental disease that can affect treatment outcome
* Patients unsuitable for this clinical trail on the opinion of researcher
TurboPower + DCB Treatment of Femoropopliteal De Novo/ Restenotic and In-Stent Restenosis Lesions

A retrospective study to evaluate Turbo Power laser atherectomy + drug coated balloon (DCB) angioplasty for the treatment of femoropopliteal de novo/restenotic lesions and in-stent restenosis (ISR).


Eligibility Criteria:
Inclusion Criteria:

* All patients treated for femoropopliteal de novo/restenotic lesions or in-stent restenosis using Turbo Power laser atherectomy plus drug coated balloon angioplasty

Exclusion Criteria:

* Any incomplete data on procedural approach and treatment
The Comparison Between Computed Tomography and Colonoscope in Detecting Colorectal Tumors in Patients With FIT+

Colonoscopy is the mainstay modality of choice in colorectal cancer screening worldwide. However, the rate of colonoscopy for colorectal cancer screening is very low (approximately 5-10%) because of the limited local medical resources (such as endoscopists and regional endoscope). This observational diagnostic test study aims to compare the diagnostic yield of routine computed tomography and colonoscopy in detecting colorectal tumors in patients at risk of colorectal cancer (aged more than 50 years and FIT+). The main question\[s\] it aims to answer are:

1. To compare the diagnostic yield between the routine computed tomography and colonoscopy.
2. To compare the procedure-related adverse events between the routine computed tomography and colonoscopy.

All enrolled patients underwent routine CT scans of whole abdomen, then subsequently under went a colonoscopy on the next day

Eligibility Criteria:
Inclusion Criteria:

1. Fit test +
2. Normal platelet count and normal result of PT, PTT

Exclusion Criteria:

1. pregnancy or lactation
2. uncontrolled Diabetes Mellitus, hypertension, asthma, congestive heart failure
3. recent coronary artery disease within 3 months
4. eGFR lesser than 30 mL/min/1.73m2
5. hemophilia or uncontrolled or uncorrected coagulopathy