cyrilzakka/clinical-trials huggingface dataset:
Application of Circulating Tumor DNA Test in the Diagnosis and Treatment of Patients With Advanced Rectal Cancer

Application of circulating tumor DNA detection in diagnosis and treatment of locally advanced rectal cancer. First, to explore the feasibility of ctDNA as a detection index for rectal cancer. Second, evaluate the accuracy of ctDNA detection in rectal cancer. Third, to explore whether ctDNA can be used in the evaluation of preoperative concurrent chemoradiotherapy, so as to provide guidance for subsequent treatment. Fourth, to explore the guidance value for the decision of postoperative adjuvant therapy and the frequency of reexamination. Fifth, search for possible recurrence related mutations.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed primary rectal cancer；
* First treatment；
* 18 years of age or older, male or female；
* According to the indications of operation, surgical treatment can be carried out；
* According to the indications of radiotherapy, radiotherapy can be carried out；
* The physical status score of ECOG was 0\~1；
* Organ function is appropriate;
* Expected survival time more than 3 months；
* During the treatment period and 6 months after treatment, contraception was not in lactation；
* The patient volunteered and signed the informed consent.

Exclusion Criteria:

* Poor compliance and failure to receive medication or follow up according to plan；
* There are other serious violations of the programme;
* At present, it has been included in other clinical trials, or at the same time, it has been included in other medical research which is judged to be incompatible with this research；
* It has a history of other cancers. Unless the cancer is completely relieved, the disease is not treated for more than 3 years.
Safety and Diagnostic Performance of uPAR PET Imaging in Localised, Untreated Prostate Cancer

The goal of this clinical trial is to test if the experimental agent accurately determines the aggressiveness of prostate cancer (biopsy-verified ISUP grade). The aim is that the diagnostic PET imaging agent may be used as an alternative or supplement to biopsies in the monitoring of patients with low-risk prostate cancer in active surveillance.

Patients diagnosed with untreated, low-grade, localized prostate cancer may participate in the trial. The experimental diagnostic agent 64Cu-DOTA-AE105 is a radiopharmaceutical which is injected into the veins and binds to uPAR expressing cells in the tumour which can then be visualized in a PET scanner.

The main question the trial aims to answer is: Can the test drug be used alone or as a supplement to repeated biopsies to accurately assess the aggressiveness of prostate cancer?

The trial is divided in 2 parts:

* Participants in the first part will receive 2 injections of test drug on 2 different days.

  * The first day the participant will receive an injection of the test drug and then be asked to lie down in the PET/CT scanner so that images of the prostate can be taken. Before and after the injection/scanning procedure the participant will have tests done. These tests will include evaluation of health status, measurement of heart function by ECG plus blood and urine samples.
  * After 8 days the procedures, including injection of test drug and scanning, will be repeated.
* Participants in the second part of the trial will only have 1 injection of the test drug and subsequent PET/CT scanning. Like in Part 1 of the trial, tests will be done before and after the injection/ scanning procedure.


Eligibility Criteria:
Inclusion Criteria:

* Pathology-verified prostate adenocarcinoma
* International Society of Urological Pathology (ISUP) grade 1 to 3
* Localised prostate cancer (N0 and M0 status) (only required for ISUP 3 patients)

  1. Newly diagnosed patients: Staging must be performed within 6 months from enrolment into the trial.
  2. Active surveillance: N0/M0 at the time of diagnosis and no clinical suspicion of prostate cancer outside the prostatic bed at the time of enrolment into the trial.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Prostate biopsy within 1 to 6 months (patients with a biopsy within the last month are excluded to avoid possible inflammation artefacts on the PET scan)

  1. The biopsy can be part of the primary staging, a confirmatory biopsy, or serial biopsy as part of an AS.
  2. At least 1 core must be MRI-guided.

Exclusion Criteria:

* Any prior treatment for prostate cancer (surgery, external beam radiation therapy, brachytherapy, hormone therapy, or chemotherapy)
* Chronic prostatitis (any signs or symptoms of chronic bacterial prostatitis or chronic pelvic prostatitis and pain syndrome, or known diagnosis of asymptomatic inflammatory prostatitis)
* Acute infections within the prostatic bed or lower urinary tract infections
* Participants have inadequate bone marrow, kidney, liver, heart, or lung function:
Markers of Severity (CD177,S100A8 &S100A12) in Sever Acute Respiratory Syndrome Coronavirus 2(SARS-COV-2) Patients

Patients infected with covid-19 have a series of clinical manifestations, including fever, cough, myalgia or fatigue, dyspnea, even acute respiratory distress syndrome (ARDS), acute cardiac injury and secondary infection, and a lot of sever patients had to been admitted to the intensive care unit (ICU)

One of the hallmark of COVID 19 is the cytokine storm that provokes primarily pneumonia followed by systemic inflammation. besides the positive viral nucleic acid analysis and the representative pulmonary CT findings (bilateral distribution of patchy shadows and ground glass opacity), most individual patients showed the changes in several immunological and biological markers . CD177 which is one of the most clinically important neutrophil alloantigen because: i) it is a neutrophil-specific marker representative of neutrophil activation, ii) it was the most highly differentiated expressed gene in patients, and iii) the protein can be measured in the serum, making its use as a marker clinically applicable. It is expressed on neutrophils, neutrophilic metamyelocytes, and myelocytes . Given the contribution of the neutrophil activation pathway in the clustering of COVID-19 patients, neutrophil-activation features that could act as possible reliable markers of disease evolution.


Eligibility Criteria:
Inclusion Criteria:

* COVID 19 hospitalized patients (diagnosed by RT-PCR)

Exclusion Criteria:

* Age below 18 years and above 80.
Comparison of Coagulation Profiles Between Zoely and Minidoz: RCT

The purpose of this study is to compare the effects of Zoely® and Minidoz® on hemostatic profiles

compare the effects of Zoely® and Minidoz® on hemostatic profiles : D-dimer, Antithrombin and fibrinogen

Eligibility Criteria:
Inclusion Criteria:

* Woman age 19-40 yr
* Normal uterus and both adnexae
* BMI \< 28.5 kg/m2
* Require contraception with COCs

Exclusion Criteria:

* Pregnancy
* Postartum period within 6 wk
* Smoking
* BP ≥ 140/90 mmHg
* Contraindication to COCs : VTE, cerebrovascular disease, cardiovascular disease, migraine with aura, hepatitis, undiagnosed abnormal uterine bleeding, CA breast, DM with DN/DR
* use of liver-enzyme-inducing drugs, drugs affecting the haemostatic system
* Use contraceptive steroids within 3 months
Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa

The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa.

The overall aim of this trial is to investigate which PrEP support strategies most effectively and efficiently optimize(s) PrEP persistence among female sex workers (FSW) and adolescent girls and youth women (AGYW) in South Africa. The trial will be implemented by TB HIV Care, a South African non-profit organization that provides direct HIV service delivery to FSW and AGYW across 10 districts in South Africa. The investigators plan to individually randomize 304 FSW and AGYW at the TB HIV Care site in uMgungundlovu, KwaZulu-Natal, to a fractional factorial trial, randomizing combinations of four separate strategies to support PrEP continuation. As fthe strategies are being tested, this results in 16 different intervention/study conditions, with one condition serving as a control where FSW and AGYW will receive the standard of care and no additional PrEP support. The other 15 conditions will be a combination of the standard of care alongside different PrEP delivery and support strategies implemented by TB HIV Care: case management, food vouchers, peer support buddies, and PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use and persistence, so that these services can be scaled up to other TB HIV Care sites. By utilizing the fractional factorial design in alignment the multiphase optimization strategy framework (MOST) the trial is feasible to conduct even with 16 arms, as the design compares results in arms with and without each of the strategies, but is not fully powered to test every combination of strategies.Thus, each strategy will be received by half of the participants, though the combinations of strategies will vary.

Eligibility Criteria:
Inclusion Criteria:

* Initiated PrEP within the past 48 hours by the TB HIV Care PrEP programme in uMgungundlovu through the female sex worker (FSW) or adolescent girls and young women (AGYW) PrEP programme teams

Exclusion Criteria:

* Not eligible for PrEP
* Currently on PrEP, but initiated onto PrEP more than 48 hours previously
* Under 16 years of age if AGYW OR under 18 years of age if FSW
COVID-19 Surveillance and Exposure Testing in School Communities

This is a prospective, observational study of COVID-19 surveillance and exposure testing in school communities. Participating school communities are providing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) tests to students and staff at their schools per school, local, and national guidelines. This study will combine data received from the schools with data collected directly from participants to guide analysis of the co-primary objectives. Participants will be grouped into two different cohorts, depending on each school's SARS-CoV-2 test administration practices.

Surveillance Cohort: Schools participating in this cohort will be performing surveillance testing weekly on approximately 10-20% of students and 100% of staff.

Exposure Cohort: Schools participating in this cohort will be performing exposure testing on students and staff who have been identified as having close contact with school members diagnosed with SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Data from all participating school communities will be included in this study (no inclusion/exclusion criteria will be assessed).

Exclusion Criteria:

* None
Assessment of Serum interleukin10 Level in Patients With Immune Thrombocytopenic Purpura at Sohag University Hospital

Autoimmune diseases are characterized by various factors that contribute to a breakdown in self-tolerance, that is, the ability of the immune system to effectively distinguish self from non-self and to refrain from attacking self. Autoimmune diseases include a broad spectrum of disorders, such as idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, and inflammatory bowel disease. Although significant progress has been achieved in the development of approaches to the treatment of autoimmune diseases, the etiologies, and pathogenesis of autoimmune diseases remain obscure (Tao et al., 2016) Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L (Neunert et al., 2019).

ITP is classified based on course of disease into acute (3- \<12 months), and chronic (≥12 months) (Provan et al., 2019). ITP usually has a chronic course in adults (Moulis et al., 2017) whereas approximately 8090% of children undergo spontaneous remission within weeks to months of disease onset (Heitink et al., 2018).

The main pathogenesis of ITP is the loss of immune tolerance to platelet auto-antigens, which results in increased platelet destruction and impaired thrombopoiesis by autoantibodies and cytotoxic T lymphocytes (CTLs) (Adiua et al., 2017).

Among these abnormalities include the increased number of the T helper 1 (Th1) cells (Panitsas et al.,2004). the decreased number or defective suppressive function of regulatory T cells (Tregs) (Yu et al., 2008) , and the


Eligibility Criteria:
Inclusion Criteria:

* Patients with platelet less than 100 × 109/L diagnosed as immune thrombocytopenia according to bone marrow findings .

Exclusion Criteria:

* Other causes of thrombocytopenia as:

  * Hypersplenism.
  * Bone marrow diseases including : aplastic anemia, leukemia and myelodysplastic syndromes.
  * patients on chemotherapy and radiation therapy for cancer management
Study of Avutometinib (VS-6766) + Adagrasib in KRAS G12C NSCLC Patients

This study will assess the safety and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with G12C Non-Small Cell Lung Cancer (NSCLC) who have been exposed to prior G12C inhibitor and experienced progressive disease.

This is a multicenter, non-randomized, open-label Phase 1/2 study designed to evaluate safety, tolerability and efficacy of avutometinib (VS-6766) in combination with adagrasib in patients with KRAS G12C mutant NSCLC who have been exposed to prior G12C inhibitor and experienced progressive disease.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects ≥ 18 years of age
* Histologic or cytologic evidence of NSCLC
* Known KRAS G12C mutation
* The subject must have received prior therapy with a KRAS G12C inhibitor and experienced progression
* Must have received appropriate treatment with at least one prior systemic regimen, but no more than 3 prior regimens, for Stage 3B-C or 4 NSCLC
* Measurable disease according to RECIST 1.1
* An Eastern Cooperative Group (ECOG) performance status ≤ 1
* Adequate organ function
* Adequate recovery from toxicities related to prior treatments
* Agreement to use highly effective method of contraceptive

Exclusion Criteria:

* Prior chemotherapy, targeted therapies, radiotherapy, immunotherapy or treatment with an investigational agent within 14 days of receipt of study drug (within 6 weeks for nitrosoureas, mitomycin C and chest radiation; within 6 months prior to Cycle 1 Day 1 for chest radiation \> 30Gy)
* History of prior malignancy, with the exception of curatively treated malignancies
* Major surgery within 4 weeks (excluding placement of vascular access)
* Exposure to strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose and during the course of therapy
* Exposure to strong inhibitors of breast cancer resistance protein (BCRP) within 14 days prior to the first dose and during the course of therapy
* Symptomatic brain metastases requiring steroids or other local interventions within the 2 weeks prior to initiation of therapy
* Known SARS-Cov2 infection ≤28 days prior to first dose of study therapy
* Known hepatitis B, hepatitis C, or human immunodeficiency virus infection that is active
* Active skin disorder that has required systemic therapy within the past 1 year
* History of rhabdomyolysis or interstitial lung disease
* Concurrent ocular disorders
* Concurrent heart disease or severe obstructive pulmonary disease
* Subjects with the inability to swallow oral medications
Retinal Imaging in Patients With Inherited Retinal Degenerations

The purpose of this study is to determine whether the structure and function of the human retina can be studied with high resolution in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser Ophthalmoscope (AOSLO).

Retinal degenerations are a group of inherited diseases that result in progressive death of the vision cells, or photoreceptors. Currently there is no treatment or cure for any of these diseases and they ultimately cause blindness in affected patients. We propose to investigate the structure and function of the human retina in patients with inherited retinal degenerations using the Adaptive Optics Scanning Laser Ophthalmoscope (AOSLO). We will correlate the images of retinal structure produced by the AOSLO with Optical Coherence Tomography (OCT) images of the retina. In addition, we will study the vision of individual photoreceptors using the AOSLO to perform a novel technique, microperimetry, in patients with retinal degenerations. We will compare the results of microperimetry with standard measures of vision used in Ophthalmology clinics, including visual acuity, automated perimetry, fundus photography and multifocal electroretinography (mfERG).

The results of this work will provide insight into the mechanism of vision loss among patients with diverse retinal disorders. Specifically, we will study cone structure and function in patients with retinal degenerations with different etiologies: retinitis pigmentosa, a disease usually caused by rod-specific mutations; cone-rod dystrophy, which primarily affects cones rather than rods; and Best's disease, a disease caused by a defect in the retinal pigment epithelium (RPE). In addition, we will study the effect that lipofuscin, a byproduct of photoreceptor metabolism that accumulates in the RPE in diseases such as Stargardt's disease, Best's disease and age-related macular degeneration (AMD), has on cone structure and function, with the goal of understanding how these diseases cause blindness. Better understanding of the mechanisms of vision loss in patients with retinal degeneration should ultimately lead to treatments for these blinding conditions.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must speak and understand English
* Subjects must have pupils that dilate to at least 6 millimeters diameter.
* Subjects must be willing to travel to University of California (UC) Berkeley.
* Subjects are financially responsible for their travel to the San Francisco area if they are not San Francisco residents.

Exclusion Criteria:

* Cataract
* Irregular corneal astigmatism (keratoconus)
* Prior refractive surgery
A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs

To make stavudine (d4T) available to patients with advanced HIV disease for whom no alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose levels in a twice-daily regimen.


Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV positivity with CD4 count \< 300 cells/mm3.
* Intolerance to or failure on approved antiretroviral therapy.
* Ability to provide informed consent (of parent or guardian if appropriate).

NOTE:

* Incarcerated persons may be eligible to participate.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Grade 2 or worse disease-related peripheral neuropathy.
* Unresolved drug-related peripheral neuropathy of any severity that is attributable to other nucleoside analogs (AZT, ddC, ddI).
* Malignancy likely to require systemic chemotherapy with myelosuppressive or neurotoxic drugs in the first 3 months of stavudine treatment.
* Pregnancy (physicians of pregnant patients may contact Bristol-Myers to determine eligibility for stavudine therapy in another protocol).

Strongly discouraged:

* AZT, ddI, ddC, and other antiretroviral agents.
SKin Uncertainties Modeling

The study is based on measurement device and will provide a database of viscoelastic properties of the forearm skin among healthy volunteers.

These data will be used to develop a mathematical model representative of the mechanical behavior of the skin.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers aged 18 to 50 years old
* non-opposition to participating in SKUM study
* Affiliation to french social security

Exclusion Criteria:

* Refusal to participate
* Volunteer with any skin disease likely to interfere with the primary outcome
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and / or weak cooperation
* Subject without health insurance
* Pregnant woman
* Subject being in the period of exclusion from another study
we Use Recovery Time to Assess Post-dialysis Fatigue and we Use Also Two Different Fatigue Scales 1- Visual Analogue Scale 2- Fatigue Severity Scale and we Address Risk Factors of PDF and Apply the Scales on Regular Hemodialysis Patients in Hemodialysis Unit of Assiut University Hospital

To improve the quality of life of hemodialysis patients and provide better control for post dialysis fatigue in regular hemodialysis patients.

Post-dialysis fatigue (PDF) is a prevalent and debilitating symptom among patients undergoing regular hemodialysis, characterized by a persistent sense of physical and mental exhaustion following dialysis sessions This condition adversely affects patients' quality of life, daily functioning, and adherence to treatment regimens .Despite its high prevalence, PDF remains under-recognized and inadequately addressed in clinical practice. The etiology of PDF is multifactorial, encompassing physiological, psychological, and lifestyle-related factors. Recent studies have identified several predictors of PDF, including sleep disorders, the presence of comorbidities, the number of weekly dialysis sessions, and the duration of hemodialysis treatment . The symptoms and severity of PDF are evaluated using various scales. In cases of PDF, to examine the subjective symptoms of patients themselves, it is useful to utilize patient-based outcomes. However, in conventional PDF studies, the evaluation indices have not been uniform. First, in studies evaluating fatigue after dialysis based on the "time," "frequency," and "intensity" the reliability and validity of the scales were not examined. Second, the recovery time is not an index that measures PDF directly but instead an indirect indicator that measures the "time to recover from hemodialysis." Third, the fatigue scale does not measure true PDF but rather chronic fatigue experienced by dialysis patients .

in that research we use time recovery to assess post-dialysis fatigue and we use also two different fatigue scales visual analogue scale to evaluate fatigue severity and fatigue severity scale In that research we address risk factors of PDF and apply the scales on regular hemodialysis patients in hemodialysis unit of Assiut University Hospital.

Eligibility Criteria:
Inclusion Criteria:

* • End stage renal diseases (ESRD) patients who receive hemodialysis 3 times a week for 4 h each time.

  * \> 20 years of age.
  * Both sexes.
  * Patients with stable clinical examination.
  * Patients who receiving hemodialysis for more than 3 months.
  * All patients were able to go to the center for hemodialysis on their own.
  * All patients who accept to share in the research.

Exclusion Criteria:

* • Ages below 20 years.

  * Patients with severe cardiovascular and cerebrovascular diseases.
  * Mental illness that is difficult to diagnose and treat.
  * Surgery within the past month.
  * Patients with acute infections.
  * Pregnancy.
  * Presence of malignancy.
  * Undergoing fracture treatment, and serious mobility.
  * patients with eye problems.