cyrilzakka/clinical-trials huggingface dataset:
Study of TJ011133 in Participants With Relapsed/Refractory Advanced Solid Tumors and Lymphoma

The purpose of this study is to assess the safety and tolerability of TJ011133 in participants with solid tumors and lymphoma.

This is an open-label, multi-center, multiple dose, Phase 1 study to evaluate the safety, tolerability, maximum tolerated dose (MTD) or maximum administered dose (MAD), pharmacokinetic (PK), pharmacodynamic, and recommended Phase 2 dose (RP2D) of TJ011133, an anti-CD47 antibody, in participants with advanced relapsed or refractory solid tumors and lymphoma. The study will be conducted in 2 parts. Part 1 comprises a single agent dose escalation (Part 1A) and 2 separate combination therapy dose escalations (Part 1B with pembrolizumab and Part 1C with rituximab) and Part 2 includes a dose expansion study.

Eligibility Criteria:
Inclusion Criteria:

* Part 1: Participants with advanced relapsed/refractory solid tumors and lymphoma.
* Part 2 with Rituximab: Participants with diffuse large B-cell lymphoma (DLBCL) or Indolent B-cell Lymphoma, with at least one measurable lesion by Lugano and available fresh metastatic biopsy sample prior to study entry.
* Part 2 with Pembrolizumab: Participants with locally advanced non-small-cell lung carcinoma (NSCLC) with disease progression or immune-oncology treatment naive Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer, with at least one measurable lesion defined by Response Elevation Criteria in Solid Tumors (RECIST) 1.1, and available fresh metastatic biopsy prior to study entry.
* All Parts: Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 and adequate bone marrow, renal, and liver functions.

Exclusion Criteria:

* Participants with known symptomatic central nervous system tumors or known central nervous system metastases or leptomeningeal disease requiring steroids. Participants who document stable and central nervous system metastases and are off steroids for more than 4 weeks may be enrolled in the study.
* Participants with Burkitt's lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma.
* Participants with mantle cell lymphoma.
* Impaired cardiac function or clinically significant cardiac diseases.
* Prior treatment with CD47 or SIRPα inhibitors.
* Prior autologous stem cell transplant \<=3 months prior to starting study.
* Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning.
* Prior chimeric antigen receptor or chimeric antigen receptor T-cell therapy.
* History of autoimmune anemia or autoimmune thrombocytopenia.
* Positive Direct Antiglobulin Test.
* Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD.
Translating ATP III Cholesterol Management Guidelines Into Primary Care Practice

This quality improvement trial aims to evaluate whether giving patients information about their coronary heart disease risk via a computer kiosk in the doctors waiting room and providing primary care doctors with a personal digital device with a decision support tool to help with cholesterol management will improve cholesterol management compared to usual care.

This project will demonstrate and evaluate the translation of the ATP III Cholesterol management guidelines into primary care practice. During phase I, a needs assessment will evaluate barriers and facilitators to implementation of ATP III guidelines into clinical practice through focus groups of primary care patients and providers. Using formative evaluation and feedback from semi-structured individual interviews of patients and providers and participant observation during pilot testing in 6 primary care practices, three tools will be refined and tailored: a computerized patient activation tool based upon NHLBI web-based 10-year CHD risk score that will be placed in each primary care office's waiting room for patient use; an ATP III interactive guidelines tool for hand held device (PDA) to be used by primary care providers as a decision support tool at the point of care and academic detailing materials consisting of a practice manual, interactive, PowerPoint slides, and practice materials to be used during an academic detailing session. During phase 2, a block, randomized designed cluster trial will be performed with one year of intervention within primary care practices (30 practices/55 providers) throughout the state of Rhode Island and Southeastern New England to test the effectiveness of the materials developed in phase I to improve physician performance around ATP III guideline implementation and to improve clinically relevant outcomes, the percentage of patients with LDL-cholesterol at their ATP III goal. Products for dissemination from this grant will include the results of the focus groups barriers and facilitators to implementation of ATP III guidelines findings, a Medical Abstraction tool for quality of care assessment regarding ATP III guidelines, a refined computerized patient activation tool, a tailored ATP III interactive guideline tool for the PDA, tailored academic detailing materials and results of the randomized clinical trial on the effectiveness of these tools to improve primary care practice.

Eligibility Criteria:
Inclusion Criteria:Practices- within 50 miles of research unit,primary care providers, had at least 20 patients agreeing to have chart audited, agreed to be randomly allocated to the intervention or control.

Patients- age 18-80,expected to survive for at least 2 years,agreed to have limited chart audits - Exclusion Criteria:Practices- specialty practices not primary care, more than 50 miles away, involved in another cholesterol management trial, anticipating closing in the next two years.

Patients- children or adolescents,over the age of 80, dementia,comfort measures only.

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Treatment of Cutaneous Ulcers With a Novel Biological Dressing

The aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.

The hypothesis of this trial is that the cutaneous model SASS, a dermal epidermal skin substitute, created by the LOEX could be as high-performant, or even better, than the one's already existent in North America for the wound care. We anticipate showing on 6 patients that ulcer that did not close with conventional treatment, will heal or at least improve with this treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Men or women from 18 to 85 years old
2. Have a venous ulcer or a mixed ulcer

Exclusion Criteria:

Diabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy
Confronting Cancer as a Community

This study aims to better understand the cause of colorectal cancer and how to find the best treatment for Hispanic patients with colorectal cancer. The genetic information in the blood and tissues may explain why patients who have the same type of cancer and receive the same treatment do not always have the same results. By combining genetic (certain qualities or traits passed from parents to offspring) information with clinical data, such as the responses of different kinds of cancers to different treatments, this study could lead to more knowledge about why certain cancers occur and why they respond differently to treatments. Information gathered from this study may help researchers match treatments to the genetics of each patient and the genetic changes in their tumor. This approach is known as personalized medicine.

PRIMARY OBJECTIVE:

I. To create a well-characterized cohort of Hispanic patients with colon cancer, with patient-level data, genomic, transcriptomic, clinical, and outcomes data.

SECONDARY OBJECTIVES:

I. To identify genomic/transcriptomic predictors of treatment outcomes (time to recurrence, time to progression, and overall survival).

II. To identify associations between somatic tumor deoxyribonucleic acid (DNA) methylation patterns and clinical outcomes.

III. To examine patterns of patient engagement in genetic/genomic testing among Hispanic patients with colorectal cancer (CRC).

IV. To characterize the gut microbiome through a stool collection kit and nucleic acid extraction process.

EXPLORATORY OBJECTIVES:

I. To validate, characterize and discover molecular processes in the CRC tumor common to other CRC populations and specific to Hispanic patients.

II. To determine whether comorbidities are associated with variation in tumor molecular pathways and whether comorbidities are effect modifiers of associations between tumor molecular variation and disease outcomes and response to treatment in Hispanic CRC patients.

OUTLINE: This is an observational study.

Patients undergo blood sample collection, collection of archival tumor tissue and genetic testing, and complete questionnaires on study. Patients also have their medical records reviewed on study.

After return of genetic testing results, patients are followed up at 2 weeks, 12 months, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported Hispanic ethnicity
* Diagnosed with colon or rectal cancer (at any time and stage; lifetime diagnosis and in survival are eligible)
* Has a tumor tissue sample archived or plans to have tissue archived from a standard care procedure
* Age \>= 18 years

Exclusion Criteria:

* Inability to understand and the willingness to sign a written informed consent
Single-cell RNA Sequencing Resolves the Regulatory Role of HBV on the Hepatocellular Carcinoma Immune Microenvironment

In summary, with the help of single-cell sequencing technology, this study aims to focus on elucidating the influence of HBV-induced hepatocellular carcinoma cell metabolic changes on microenvironment remodeling. With the help of hepatocellular carcinoma microenvironment changes, this study provide a more accurate diagnosis and treatment method for HBV-induced hepatocellular carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary liver cancer (hepatocellular carcinoma (HCC)), with evidence of histological or cytological diagnosis, or with HCC meeting conventional clinical diagnostic criteria.
* Both sexes, aged 18-80 years old
* The results of HBVDNA test were in line with the inclusion criteria
* The patient had at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST V1.1)
* Agreed to comply with the study protocol for treatment and follow-up, agreed to provide clinicopathological and follow-up data required by the study, and agreed to use the study data for subsequent research and product development

Exclusion Criteria:

* Other malignant tumors;
* Patients with severe organic diseases do not meet the requirements of infectious liver cancer in this study;
* Suffering from mental illness cannot guarantee the compliance of this study;
* Previous recipients of any cell or organ transplantation;
* Received local regional liver therapy (including various ablations, percutaneous ethanol or acetic acid injections, high-intensity focused ultrasound, transarterial embolization, chemotherapy, or chemoembolization plus embolization) within 14 days prior to study treatment initiation.
Study of MAR001 in Adults With Metabolic Dysfunction

The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to provide informed consent and comply with the intervention
* Women of childbearing potential and men agreeing to use an appropriate method of contraception for the duration of the study
* Evidence of metabolic dysfunction at screening (triglyceride levels \> 2.8 mmol/L)

Exclusion Criteria:

* Any condition which in the opinion of the investigator prevents the participant from complying with study procedures or prevents the participant from completing the study or interferes with the interpretation of study results
* Pregnant or breastfeeding mothers
* Terminal illness with expected survival of less than 1 year

Note: additional inclusion/exclusion criteria may apply, per protocol
Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation

The purpose of this study is to compare clinical outcomes (change in bleeding sites (BOP) and probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic therapy (aPDT) and assess the microbiologic profile of plaque samples before and after treatment with or without aPDT samples.


Eligibility Criteria:
Inclusion Criteria:

* at least one implant with peri-implant inflammation that requires non-surgical treatment.
* Peri-implant diseases included are peri-implant mucositis and peri-implantitis

Criteria for diagnosis of peri-implant mucositis or peri-implantitis:

1. Red, swollen gingival tissues surrounding the implant
2. Presence of bleeding and/or suppuration on gentle probing around the implant
3. Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth)
4. May or may not have progressive bone loss in relation to radiographic bone levels assessed either 1 year following restoration of the implant OR ≥3mm of radiographic bone loss from the implant platform -systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.

Exclusion Criteria:

* current heavy smokers (\>10 cigarettes/day)
* have diabetes or other systemic diseases that may comprise healing
* take antibiotics within 3 months before the procedure
Effectiveness of Holmium and Thulium Lasers With Ureteroscopy for Urinary Lithiasis

Holmium laser is the current gold standard for lithotripsy on urinary lithiasis, while Thulium is brand new. The latter has been released in July 2020 in Europe, and only in-vitro studies have been published.

The aim of this study is to compare the stone free rate in ureteroscopy, for all consecutive patients treated with laser fragmentation, between both Holmium and Thulium lasers.

The costs and complications will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* renal ou ureteral stone confirmed by an abdominal and pelvic computed tomography
* treatment with rigid or flexible ureteroscopy
* laser lithotripsy during the procedure
* bacteriological examination of urine (sterile, bacterial colonization or treated by antibiotics)

Exclusion Criteria:

* non-use of laser for stone lithotripsy
* pregnant women
* under 18 years old
* refusal to give informed consent
* urinary malformation
A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers

This study will be conducted in healthy volunteers to investigate the effect of single dose GSK561679 on the changes of brain activation, as it compares to an active comparator, lorazepam.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males
* Non-smokers
* Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-29.9 kg/m2
* Normal ECG.

Exclusion Criteria:

* Any serious medical disorder or condition.
* Any history of an endocrine disorder.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* History or current diagnosis of acute narrow angle glaucoma.
* Left handed
Rehabilitating (Stroke-induced) Apraxia With Direct Current Stimulation

The objective of the clinical trial is to investigate whether weak transcranial direct current stimulation (tDCS) can ameliorate the motor cognitive deficit apraxia during stroke rehabilitation. Stroke patients with apraxia will either receive a real stimulation or a sham stimulation (placebo) for 10 minutes at a time on 5 consecutive days during their in-patient stay in a rehabilitation center. Additionally, motor tasks are performed before and after the stimulation. The effect of the weak current stimulation on motor function is assessed 3-4 days after the last stimulation and 3 months after enrollment.

Despite the high incidence of the motor cognitive deficit apraxia after left-hemispheric stroke, evidence-based therapies do not exist. This randomized controlled clinical trial (RCT) investigates whether anodal transcranial direct current stimulation (tDCS) as an add-on therapy during neuro-rehabilitation can ameliorate apraxic deficits in patients with left hemisphere stroke. Therefore, anodal tDCS is applied over the parietal cortex of the left, lesioned hemisphere with an intensity of 2 mA for 10 minutes at a time on 5 consecutive days in combination with motor tasks before and after the stimulation. The effect of the stimulation is compared to a sham stimulation. Moreover, application of a pre-programmed study mode ensures a double-blind study design (patient and investigator). The performance in the apraxia test KAS (Cologne Apraxia Screening) 3-4 days after the last stimulation, compared to baseline, serves as primary endpoint of the study. Secondary endpoints are evaluated using various apraxia tests, motor tests and neuropsychological tests 3-4 days after the last stimulation and 3 months after enrollment.

Eligibility Criteria:
Inclusion Criteria:

* left hemispheric ischemic stroke in the subacute/ chronic phase (\>10 days and \<180 days post-stroke)
* clinical confirmation of apraxia by KAS (Cologne Apraxia Screening), Cut-off ≤ 76/ 80 points;
* age 18 - 90 years;
* written Informed Consent

Exclusion Criteria:

* pregnancy, breastfeeding and women without exclusion of pregnancy
* patients with clinical manifestation of a stroke prior to the index-stroke
* malignant disease with affection of central nervous system
* life expectancy \<12 months
* current addiction to alcohol or drugs or other addictive disease (exception: nicotine)
* current clinically manifest psychiatric disorders, such as schizophrenia or severe depressive episode
* epileptic seizure within the past two years
* continuous medication during the intervention phase with benzodiazepine, antipsychotics of high potential and anti-epileptic drugs taken for prophylaxis of epileptic seizures
* enrollment in other studies with brain stimulation in the time period after the index stroke
* heart pacemaker
* electrodes for deep brain stimulation or other metal implants in the head (expected are dental fillings and inlays)
* craniectomy or trepanation
* vulnerable skin lesions at electrode positions
* poor motivation/ cooperation
Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer

ICK-breast is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in early and advanced or metastatic triple negative breast cancer (TNBC) under immune checkpoint inhibitor (ICI) therapy on pathological complete response (pCR) and event-free survival in early TNBC patients, and objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in advanced or metastatic TNBC.

Immunotherapy, which involves activating the body's immune system for cancer treatment, has already been widely incorporated into the standard care of breast cancer patients with early and metastatic triple-negative breast cancer (TNBC).

This study aims to investigate how inflammatory markers such as C-reactive protein (CRP) change during and after immunotherapy. Study findings from other tumor types (kidney, lung, bladder) suggest that immunotherapy is particularly effective when a mild inflammatory response is triggered in the body. The investigators want to examine this using CRP measurement. CRP measurement can easily be integrated into clinical routine as it only requires a blood sample. And since the patients already need a blood draw for chemotherapy, CRP measurement can be performed directly from the blood sample.

The goal of this prospective study is to determine whether changes in CRP levels in the blood can predict the disease progression or response to immunotherapy.

Eligibility Criteria:
Inclusion Criteria:

* women ≥ 18 years of age
* histologically proven early or advanced or metastatic invasive breast cancer irrespective of therapy line
* ER-negative and progesterone receptor (PR)-negative and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0-2+, Fluorescence In Situ Hybridization (FISH) neg.)
* patients with advanced or metastatic disease must be programmed cell death ligand 1 (PD-L1)-positive (IC ≥ 1 or combined positive score (CPS) ≥ 10) in the experimental group
* planned ICI therapy in combination with chemotherapy in the experimental group
* written informed consent into ICK-breast

Exclusion Criteria:

* ER-positive or PR-positive
* HER2-positive (IHC 2+, FISH pos or IHC 3+)
* any systemic breast cancer therapy before inclusion into the trial for early breast cancer patients
* any ICI therapy before inclusion into the trial
* pregnant or lactating patients
* inadequate general condition (not fit for chemotherapy)
FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma

The goal of this clinical trial is to evaluate the performance characteristics of O-(2-\[18F\]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of \[18F\]FET-PET in delineating disease. The main question\[s\] it aims to answer are:

* whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression
* whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET/CT of the brain in SGH.


Eligibility Criteria:
Inclusion Criteria:

* Men or Women, aged 21 years or older at time of screening
* Histologically confirmed diagnosis of malignant glioma (defined as WHO grade III or IV) with previous RT to tumour
* With enlarging contrast-enhancing and/or T2W/FLAIR-hyperintense lesion(s) on MRI within the previous RT field
* Gliomas with Isocitrate dehydrogenase (IDH) wild-type status, as defined on immunohistochemistry
* Subject must consent to undergo all study procedures

Exclusion Criteria:

* Low-grade gliomas (histology grade 1 or 2 by WHO classification)16,17
* Previous bevacizumab or other vascular endothelial growth factor (VEGF) targeting agents or anti-angiogenic treatments.
* Proven cerebral metastases
* IDH-mutated gliomas
* Pregnancy/ breast-feeding