cyrilzakka/clinical-trials huggingface dataset:
Primary Diagnosis Study for Validation of Hamamatsu NanoZoomer S360MD Digital Slide Scanner System

The primary objective of this study is to evaluate the safety and accuracy of the Hamamatsu WSI compared to those of the reference method (conventional light microscope (Glass)) under clinical use conditions as an aid for pathologists to view, review and diagnose digital images of surgical pathology slides.

The primary endpoint is the indicator of major discordance in primary diagnosis between ground truth case diagnosis and case diagnosis by each modality, WSI and Glass, separately.


Eligibility Criteria:
Inclusion Criteria:

* Cases originating from and that were diagnosed at that local site
* Cases are available in the site's archive
* Cases are at least 1 year old since accessioning
* Cases are selected because their primary diagnosis is consistent with the assigned target categories
* Cases have a set of slides representative of the primary diagnosis for which it has been selected

Slide selection for a given case must meet the following criteria:

* Slide is obtained by surgical pathology and prepared from FFPE human tissue
* Slides must be stained with H\&E and accompanying special stains (histochemical and/or immunohistochemical)
* All special stains slides (histochemical and/or immunohistochemical) where the slide and stain is used for diagnosis, not prognosis.
* A chosen slide must demonstrate and be representative of the primary diagnosis; 1 slide selection may suffice for biopsy cases,
* For resection cases, a minimum of 5 slides must be selected, which represent the primary diagnosis. If represented with less than 5 slides, additional slides (primary, secondary, or benign slides) from same case may be used to fulfill minimum number
* Slide is intact, has correct size/thickness, good edges, undamaged coverslip, without pen markings that can't be removed, no air bubbles, tidy labels, and fulfills the quality checks per the general clinical practice

Exclusion Criteria:

* Case does not have relevant slides or if case information necessary for the study is missing
* Case is still active (less than 1 year old) at the local site
* Cases for which the control slides for immunohistochemistry and special stains are not available
* Two cases from same individual
* Gross-only cases that have no slides
* Cases that are frozen section, cytology or hematology or immunofluorescence specimens only
* Case where the only available set of slides have evidence only of secondary or no diagnoses and not the primary diagnosis for which the case is being screened.

Slides for a given case will be excluded if they meet the following criterion:

• Glass slide that is broken, has abnormal size/thickness, beveled edges, poor coverslip (cracks, waviness, scratches), is sticky, has many pen markings or dirt that cannot be removed, contains air bubbles and overhanging labels that can't be corrected, and if stain is severely faded.
Volar Locked Plating Versus Bridging External Fixation

A randomized, prospective comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 \& C3.

Hypothesis:

There is no significant difference in using volar plates compared to Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 \& C3 as evaluated by a Quick-DASH score at 24 months follow-up.

We have designed a randomized, prospective study for comparison of volar locked plating versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with comminuted distal radius fractures, AO/OTA type C2 \& C3. On the basis of power analysis a total of 140 patients are to be included in this project. The follow-up period is 2 years and evaluation is based on x-ray analysis, grip strength, range of movement, pain and various tools to measure quality of life and satisfaction with the treatment (EQ-5d, SF-36, Quick-DASH).

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to Ahus and Lillestrom legevakt with a distal radius fracture are to be classified according to the system of the Orthopaedic Trauma Association (AO/OTA).
* All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture, or a dislocated C1-fracture, are eligible for inclusion.

Exclusion Criteria:

* Gustillo-Anderson type III open fractures
* Previous distal radius/ulna-fracture and/or disabling hand injury of the same extremity
* Dementia
* Congenital anomaly
* Bilateral radius fracture
* Pathological fracture other than osteoporotic fracture
* Congenital bone disease (for example osteogenesis imperfecta)
* Age below 18 and above 70
* Disabling nury to other parts og the movement apparatus at the same time as the current injury
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.

Study comparing intrasphincteric injection of iltamiocel with placebo. Subjects unblinded after 12 month visits, but followed for up to 2 years. Subjects randomized to placebo could elect to receive open-label iltamiocel after completing 12 month visit.

Eligibility Criteria:
Inclusion Criteria:

* Female patient has primary symptoms of SUI, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation.

Exclusion Criteria:

* Patient has symptoms of pure urge incontinence as confirmed by basic evaluation of etiology from a patient medical history, including a focused incontinence history.
* Patient has symptoms of mixed urinary incontinence where urge incontinence is the predominant factor.
* Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent.
* Patient has not previously attempted conservative treatment prior to signing the informed consent. (Examples of conservative treatment include behavior modifications, bladder exercises, biofeedback, etc.)
* Patient has more than 2 episode of awakening to void during normal sleeping hours.
* Patient cannot be maintained on a stable dose and/or frequency of medication (including diuretics) known to affect lower urinary tract function, including but not limited to, anticholinergics, tricyclic antidepressants or alpha-adrenergic blockers, for at least 2 weeks prior to screening or is likely to change during the course of the study.
* Patient is pregnant, lactating, or plans to become pregnant during the course of the study.
* Patient refuses to provide written informed consent.
* Patient is not at least 18 years of age.
* Patient is not available for the follow-up evaluations as required by the protocol.
Effects of Recess Timing and Activity on Children's Eating Behaviors

This study aims to understand the interaction between school recess activity and duration and lunch choices among elementary school children


Eligibility Criteria:
Inclusion Criteria:

* Parental/guardian consent
* 8-11 years of age

Exclusion Criteria:

* No parental/guardian consent
* Below 8 years and above 11 years
Loving-Kindness Meditation for PTSD

This randomized controlled trial will assess whether a novel complementary and alternative medicines (CAM) intervention, Loving-kindness Meditation (LKM), is not meaningfully inferior to another group-based PTSD treatment , Cognitive Processing Therapy (Cognitive Only version; CPT-C) for reductions in PTSD and depressive symptoms. 170 male and female Veterans with current PTSD will be randomized to LKM or CPT-C. The investigators hypothesize that Veterans randomized to LKM will report mean reductions in PTSD and depressive symptom severity that are not meaningfully worse than CPT-C. The investigators further hypothesize that reductions in posttraumatic maladaptive beliefs will more strongly mediate PTSD and depressive symptom improvement for those assigned to CPT-C than those assigned to LKM.

Aim 1: Evaluate if LKM is non-inferior to CPT-C in producing reductions in PTSD symptoms among Veterans with current PTSD. Aim 2: Evaluate the non-inferiority of LKM and CPT-C in producing reductions in depressive symptoms among Veterans with current PTSD. Exploratory Aim: Evaluate potential mediators of response to LKM and to CPT to provide preliminary information regarding whether they are consistent with the mechanisms of change conceptualized by each intervention to be associated with improvement in PTSD and depression.

Methods: A randomized controlled non-inferiority trial comparing LKM to CPT-C. In the proposed project 170 Veterans with PTSD will be randomized to LKM or CPT-C. Comprehensive assessments will be performed at baseline as well as at the end of the 12-week interventions and 3 and 6 months later. PTSD symptoms, depression, posttraumatic maladaptive cognitions and self-compassion will be assessed weekly during the treatment phase to assess temporality of change and to assess mediators of outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Current Diagnostic and Statistical Manual of Mental Disorder (DSM)-5 diagnosis of PTSD,
* 18 or over,
* English fluency,
* Willingness to not participate in Mindfulness-Based Stress Reduction or other meditation programs, as well as Prolonged Exposure (PE) or CPT during the study period.

Exclusion Criteria:

* Any of the following substance use criteria: 1) Use in the past 90 days of illicit substance (do not include cannabis)/ street drug (non-prescribed); 2) Use in the past 90 days of prescription drug of abuse, use is not as prescribed AND poses safety concern
* Alcohol involvement that poses a safety concern or is associated with inability to follow through on assessments and class attendance as evinced by current drinking AND dt's or seizure in past year
* Suicidal or homicidal ideation with intent or plan
* Attempted harm to Self or others in the past month
* A lifetime psychotic disorder or current psychotic symptoms
* Uncontrolled bipolar disorder (ie current mania, current hypomania is not an exclusion)
* Chart diagnoses of borderline personality disorder or antisocial personality disorder
* In-patient admission for psychiatric reasons within the past month
* Prior participation in LKM or CPT
* Dementia
A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors

This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors with FGFR2 and/or FGFR3 genetic alternations.


Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.
2. Previously treated with, not appropriate for, or declined standard-of-care first-line treatment.
3. Have measurable disease per RECIST v1.1.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
6. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug. Exceptions are alopecia, hypothyroidism, or type 1 diabetes mellitus controlled with medical intervention, and paronychia controlled with local intervention.

Key Exclusion Criteria:

1. Received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
3. Clinically significant corneal or retinal disorders or current evidence of retinal detachment.
4. Received more than 2 prior FGFRi therapies
5. Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.
Ovarian Cancer and Immune Response to Flu Vaccine

The purpose of this study is to determine what the immune response is of ovarian cancer patients in remission, when they are given the flu vaccine. After receiving the flu vaccine, patients will have blood drawn 5 times in 12 months to study antibody response to the flu vaccine.


Eligibility Criteria:
Inclusion Criteria:

* All subjects must have a histologic diagnosis of epithelial ovarian cancer or primary peritoneal carcinoma. Time from completion of chemotherapy will be no more than 6 months.
* If no clinical evidence of disease is present after diagnosis with Stage III or IV disease and completion of primary surgery and chemotherapy, or, if no clinical evidence of disease is present after completion of chemotherapy for a disease recurrence diagnosed after a progression-free interval of at least 2 years, for patients of any initial stage.

Exclusion Criteria:

* Prior malignancy (except basal cell or squamous cell skin cancer) within the past five years.
* Presence of active CNS disease.
* Active bacterial, viral or fungal infections.
* Chemotherapy, biologic therapy, or radiation therapy \< 4 weeks prior to study entry.
* History of active autoimmunity or immunosuppression.
* Use of immunosuppressive drugs within 4 weeks prior to study entry. Patients may receive chemotherapy or other immunosuppressive medications at the discretion of their physician during the subsequent year after influenza vaccination without exclusion from the study.
* Patients with tumors of low malignant potential (borderline tumors) will not be eligible.
* Prior influenza vaccination with the current vaccine.
* History of serious sensitivity to eggs, or previous influenza vaccine.
* Pregnant of breastfeeding subjects.
Novel Imaging Techniques for the Characterization of Musculoskeletal Tumors II

This study aims at evaluating the value of various artificial intelligence based techniques to improve the characterization and image post-processing for patients with musculoskeletal tumors.

Comparison of values relating to the texture parameters of tumors evaluated by MRI and ultra-high resolution CT between benign and malignant lesions using histological analysis as the standard of reference.

Comparison of the diagnostic performance of texture parameters derived from different MRI sequences and ultra-high resolution CT for musculoskeletal tumor characterization.

Evaluate the impact of ultra-high resolution with respect to standard resolution on CT images Comparison of the diagnostic performance of the texture parameters for the tumor on the diagnostic performance of texture analysis derived parameters for the characterization of musculoskeletal tumors.

Evaluate the effectiveness and accuracy of automatic artificial intelligence (AI) based tumor segmentation tools.

Evaluate the use of trabecular analysis on ultra-high resolution CT images for the evaluation of tumor-bone interfaces.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected to have a bone or soft-tissue tumor referred for imaging for initial tumors characterization and staging.

Exclusion Criteria:

* Pregnancy
* Breast feeding patients
* Renal insufficiency
* Contra indications to MRI or CT
* Prior surgery or treatment to the evaluated lesion.
Intrathecal Double Checkpoint Inhibition in Combination with Pemetrexed

The objective of the present study is to evaluate the tolerability, feasibility, safety and therapeutic response of intrathecal administration of double checkpoint inhibition(QL1706) in combination with pemetrexed in patients with leptomeningeal metastasis.

Previous studies have demonstrated that combining PD-1 monoclonal antibody immunotherapy with intrathecal pemetrexed is both safe and effective.

The treatment regimen within the IT-P-QL1706 study consists of intrathecal administration of iparomlimab and tuvonralimab (QL1706) in combination with intrathecal pemetrexed.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of solid tumors; Cerebrospinal fluid cytopathology is positive.
2. Male or female aged between 21 and 75 years; Normal liver and kidney function; WBC≥4000/mm3, Plt≥100000/mm3.
3. No history of severe nervous system disease; No severe dyscrasia.

Exclusion Criteria:

1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
3. A history of HIV or AIDS, acute or chronic hepatitis B or C infection, previous anti-PD1 therapy-induced pneumonitis, or have ongoing \>Grade 2 adverse events of such therapy; or ongoing autoimmune disease that required systemic treatment in the past 2 years.
4. Patients with poor compliance or other reasons that were unsuitable for this study.
Beat COVID-19 - Observational Trial

JUPITER is an observational study protocol that aims to understand factors that can help prevent/mitigate the spread of COVID-19 and understand factors that help reduce disease progression in patients with COVID-19. We aim to accomplish this by obtaining self-reported historical and longitudinal data from study participants.

This is an observational study that will electronically collect self-reported participant data in a database that follows HIPAA security requirements for those with a clinically confirmed case of COVID-19 or those who have had exposure to COVID-19.

The aim of this study is to gather a large, diverse dataset from a large population of participants in order to gather longitudinal observational data on what health practices participants are practicing and what, if any, benefits these practices may be providing the participants.

Data for this study will be gathered via self-reporting from participants who wish to participate in the fight against COVID-19. This will include getting a baseline of each participant's health and then monitor their health over time while looking at how their symptoms are progressing or regressing. The JUPITER study may also seek historical data from patients who have recovered from COVID-19.

The JUPITER dataset may be shared (in accordance with applicable state, federal, and local laws) so that others may utilize the data from the dataset for further analysis to determine relevant trends in the data and in turn hopefully use these trends to determine potential treatment protocols or lifestyle recommendations to help prevent COVID-19 spread and reduce hospitalization rates, as well as to understand how certain factors may aide in the COVID-19 disease progression.

Eligibility Criteria:
Inclusion Criteria:

1. Adults residing in the United States aged 18 years or older proficient in understanding and reading the English language who wish to participate in the fight against COVID-19 by providing self-reported health information.
2. Ability to complete electronic informed consent process.
3. Ability to use the internet and check email regularly.
4. Consent to provide a HIPAA waiver of health information to share protected health information.

Exclusion Criteria:

1. Inability to provide regular updates to their health status when contacted by the BEAT COVID study personnel via email or SMS.
Ultrasound-guided Arterial Catheterization in Pediatric Patients

Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.


Eligibility Criteria:
Inclusion Criteria:

* Surgery under general anesthesia
* Requires invasive arterial blood pressure monitoring

Exclusion Criteria:

* Infection/hematoma/skin disease/arteriovenous fistula/recent catheterization scar in radial artery or posterior tibial artery
* Peripheral vascular disease
* Congenital aortic disease
Efficacy of Perifosine Alone and in Combination With Dexamethasone for Patients With Multiple Myeloma

This is a phase 2 study of perifosine in patients with multiple myeloma. Patients will receive perifosine 150 mg at bedtime (qhs) daily. Patients will be assessed by serum and/or urine-electrophoresis at least every 3 weeks.

Treatment: Patients will take three 50 mg tablets of perifosine qhs daily with food. All patients should continue therapy unless disease progression is documented on two occasions at least 1 week apart. Progressing patients will have dexamethasone 20 mg twice per week added to the perifosine. Patients who experience toxicity may continue on treatment with doses delayed or reduced.

Evaluations: Serum and/or urine-electrophoresis will be evaluated for progression or response at 3 week intervals.

This study will enroll a total of up to 64 patients.

Eligibility Criteria:
Inclusion Criteria:

Major criteria:

1. Plasmacytomas on tissue biopsy.
2. Bone marrow plasmacytosis (\> 30% plasma cells).
3. Monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin G (IgG) \> 3.5 g/dL or immunoglobulin A (IgA) \> 2.0 g/dL; kappa or lambda light chain excretion \> 1 g/day on 24 hour urine protein electrophoresis.

Minor criteria:

1. Bone marrow plasmacytosis (10 to 30% plasma cells)
2. Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria
3. Lytic bone lesions
4. Normal immunoglobulin M (IgM) \< 50 mg/dL, IgA \< 100 mg/dL or IgG \< 600 mg/dL.

Any of the following sets of criteria will confirm the diagnosis of multiple myeloma:

1. Any two of the major criteria.
2. Major criterion 1 plus minor criterion b, c or d.
3. Major criterion 3 plus minor criterion a or c.
4. Minor criteria a, b and c or a, b and d.

Exclusion Criteria:

1. Renal insufficiency (serum creatinine levels \> 3 mg/dL).
2. Patients who present with either ALT or AST ≥ 2.5 X upper limit of normal.
3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine).
4. Concomitant therapy medications that include corticosteroids (except as indicated for other medical conditions, or up to 100 mgs of hydrocortisone as premedication for administration of certain medications or blood products) or other chemotherapy that is or may be active against myeloma, or therapy with chemotherapy within 3 weeks prior to Day 1. Nitrosoureas must be discontinued 6 weeks prior to Day 1.
5. Subjects with a hemoglobin \< 8.0 g/dL.
6. Any condition, including laboratory abnormalities, that in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study.
7. Women of childbearing potential (WCBP) who are pregnant, or breast-feeding or men and women who are not using adequate contraception are excluded.
8. Plasma cell leukemia.