cyrilzakka/clinical-trials huggingface dataset:
Prospective Research Rare Kidney Stones (ProRKS)

The purpose of this study is to determine the natural history of the hereditary forms of nephrolithiasis and chronic kidney disease (CKD), primary hyperoxaluria (PH), cystinuria, Dent disease and adenine phosphoribosyltransferase deficiency (APRTd) and acquired enteric hyperoxaluria (EH). The investigator will measure blood and urinary markers of inflammation and determine relationship to the disease course. Cross-comparisons among the disorders will allow us to better evaluate mechanisms of renal dysfunction in these disorders.

Severe, hereditary forms of nephrolithiasis cause marked excretion of insoluble minerals important in stone formation, including primary hyperoxaluria, cystinuria, Dent disease, and adenine phosphoribosyltransferase deficiency (APRTd). Patients with these disorders experience recurring stones from childhood and are at high risk for chronic kidney disease caused by crystal nephropathy. Enteric hyperoxaluria is an acquired disease characterized by hyperoxaluria and calcium oxalate crystal nephropathy associated with chronic kidney disease, and in that respect similar to the inherited stone diseases. The investigators will collect longitudinal data of individual patients in order to provide clues about potentially modifiable factors that influence disease severity and identify factors leading to kidney injury. the investigator will measure blood and urinary markers of inflammation and determine relationship to the disease course. Cross-comparisons among the disorders will allow to better evaluate mechanisms of renal dysfunction in these diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of primary hyperoxaluria
2. Diagnosis of enteric hyperoxaluria
3. Diagnosis of Dent Disease
4. Diagnosis of Cystinuria
5. Diagnosis of adenine phosphoribosyltransferase deficiency (APRTd)
6. Diagnosis of Lowe Syndrome
7. Diagnosis of Dent Disease Carrier

Exclusion Criteria:

1. Prior renal failure
2. History of liver and/or kidney transplant.
Neutrophil Elastase and Elafin as Prognostic Biomarker for Acute Respiratory Distress Syndrome

The acute respiratory distress syndrome (ARDS), characterized by alveolar flooding with protein-rich pulmonary edema fluid, is one of the most common disease in the intensive care unit (ICU) throughout the world. In recent years, much effort has been focused on the biological markers for their potential values to diagnose ARDS and outcomes.

ARDS is generally accompanied by the disruption in alveolar-capillary barrier permeability, which subsequently caused an influx of neutrophils into the interstitium and alveolar space. It was reported that the aggregation, adhesion activation and release proteases of neutrophils are the key pathogenesis of ARDS pulmonary edema. Neutrophil Elastase (HNE), the most crucial protease generated in neutrophil azurophilic granules, plays an important role in various inflammations, especially the lung injury. The destructive action of HNE on almost all extracellular matrix influences cell signaling through cleavage of surface receptors. Once released in circulation, HNE is rapidly inactivated by conjugation with PI3. This local inhibitor reduces HNE mediated tissue injury and inflammation. Thus, the investigators plan to conduct a cohort study with repeated measures to examine the diagnostic and prognostic value of HNE and PI3 for ARDS.


Eligibility Criteria:
Exclusion Criteria:

* Age \<18 years
* History of chronic lung diseases, such as interstitial pulmonary fibrosis or bronchiolitis
* history of pneumonectomy
* Treatment with immunomodulating therapy other than corticosteroids, such as granulocyte colony stimulating factor, cyclophosphamide, cyclosporine, interferon, or TNF-α antagonists
* Presence of other immunodeficient conditions, such as HIV infection, leukemia, or neutropenia (absolute neutrophil count \<1000/μl)
* History of organs or bone marrow transplant other than autologous bone marrow transplant
* Directive to withhold intubation
* ICU stay duration\<72h
* Patient developed ARDS before ICU admission. Sepsis and septic shock were defined according to the Berlin definition
Effects of Strength Training on Musculoskeletal Overuse Injuries in Female Runners

The purpose of this study is to look at the effect of strength training in preventing overuse injuries in female runners

This randomized clinical trial will compare the effects of 9-months of strength training to a control group on: (1) injury rates in female runners during the 9 month intervention period, and for 9 months after completing the intervention, and (2) on the potential mechanisms of injury including strength, joint and tissue loading, and psychosocial factors.

Eligibility Criteria:
Inclusion Criteria:

* Female civilian runners between 18-60 years old
* Run at least 5 miles per week for the past 6 months
* No overuse injuries in the past 6 months
* Plan to stay in the area for the next year and a half
* Live less than 30 miles from Wake Forest University or High Point University

Exclusion Criteria:

* Male
* Under age 18 and over age 60
* Chronic diseases, orthopedic conditions, past anterior cruciate ligament tears
* Currently pregnant or planning to conceive within the next 18 months
* Observed by study staff as unwilling to attend testing/intervention sessions
* Observed by study staff as unwilling to communicate via telephone and email regularly with study personnel
* Participated in formal strength training in the past 6 months
* Current active military or active military reserve
Study of AT-527 in Subjects With Normal and Impaired Renal Function

Study of AT-527 in Subjects with Normal and Impaired Renal Function


Eligibility Criteria:
Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* BMI of 18.5 to 42.0 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Subjects with Normal Renal Function (Group E):

* Medically healthy, in the opinion of an Investigator
* Normal renal function with eGFR ≥ 90 mL/min/1.73m2 at Screening

Renal Impaired Subjects (Groups A, B, and C):

* Considered stable in the judgement of an Investigator
* Presence of severe renal impairment (eGFR ≥ 15 and \< 30 mL/min/1.73m2), moderate renal impairment (eGFR ≥ 30 and \< 60 mL/min/1.73m2) or mild renal impairment (eGFR ≥ 60 and \< 90 mL/min/1.73m2) at Screening: renal impairment should have been stable for at least 1 month prior to Screening.

Subjects with End-Stage Renal Disease -ESRD (Group D)

* Considered clinically stable in the opinion of the Investigator
* Presence of ESRD (eGFR \<15 mL/min/1.73m2 and being on intermittent hemodialysis) at Screening and have been stable for at least 1 month prior to Screening

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities

Subjects with Normal Renal Function (Group E):

• Any clinically significant illness in the opinion of the investigator

Subjects with Impaired Renal Function (Group A, B, C and D):

* History of renal transplant
* Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) \> 10%
* Subjects requiring treatment for renal impairment or other chronic disease must be on a stable treatment plan
An Investigational Scan (Me-4FDG PET/CT) for the Detection of Sodium-Glucose Transport for Early Diagnosis of Lung Cancer

The phase I/II trial assess the safety and efficacy of a new positron emission tomography (PET) test for early diagnosis of lung cancer. This study uses PET and Me-4FDG new glucose tracer (alpha-methyl-4-deoxy-4-\[(18)F\]fluoro-D-glucopyranoside) designed specifically to determine glucose update into cells in the body. PET is a non-invasive imaging method used to detect cancer in patient. Me4FDG is a radioactive glucose tracer used in PET to locate cells in the body taking up glucose by SGLT2. SLGT2 is a sodium glucose transport protein that accumulates glucose in some cells, e.g. kidney cells and tumors. This study may help researcher determine how effective PET with ME4FDG tracer works in detecting lung cancer.

PRIMARY OBJECTIVE:

I. Assess the safety and efficacy of alpha-methyl-4-deoxy-4-\[(18)F\]fluoro-D-glucopyranoside (Me-4FDG) for early diagnosis of lung cancer.

SECONDARY OBJECTIVE:

I. Evaluate the correlation of Me-4FDG positivity with histopathological features of the disease (tumor grade, expression of sodium-glucose cotransporter-2 inhibitors.(SGLT2).

OUTLINE:

Patients receive Me-4FDG tracer intravenously (IV) and then undergo PET/CT over 15 minutes.

After completion of study , patients are followed up at 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Lung nodule \>= 1 cm visualized by CT imaging
* CANCER ARM: Pathologically confirmed lung adenocarcinoma. For patients who are surgical candidates, the pathologic report on the surgical specimen will confirm the diagnosis. For patients who are not surgical candidates, the enrollment will be contingent upon a pathologic diagnosis of lung cancer obtained by needle biopsy
* BENIGN ARM: Lung nodules considered to be clinically benign, according to the Guidelines for Management of Incidental Pulmonary Nodules from the Fleischner Society. Will consider "benign" the nodules with a lung-RADS score of 1-3

Exclusion Criteria:

* Pregnancy
* Diagnosis of diabetes
* Current treatment with SGLT2 inhibitors or metformin
MRI-Guided Cryoablation for Focal Native Prostate Cancer

The purpose of this research is to collect data about the MRI cryoablation procedure your doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after the participants treatment is performed.

Participants have been asked to take part in this research because the participants have been diagnosed with prostate cancer and scheduled to have an ablation procedure.

The purpose of this study is to evaluate MR-guided cryoablation of biopsy proven prostate tumors using the Galil MRI-compatible cryoablation system. The system has been approved by the United States Food and Drug Administration (FDA) for soft tissue ablation and has been utilized successfully at Mayo. All procedures will be performed according to approved indications. the investigators wish to monitor the technique and collect data at the participants follow-up visits.

The study only collects data about the MRI-guided cryoablation procedure the participants doctor(s) would normally perform in order to treat the participants focal prostate cancer and to evaluate the participants condition after there treatment is performed. The participants doctor will advise the participants when the participants should return for follow-up visits. These visits will be according to the participants doctor's standard of care; usually return visits are at 3-6months, 12 months, 24 months, 36 months, 48 months and 60 months after the procedure, although the participants doctor may ask that the participants return for more frequent visits.

Eligibility Criteria:
Inclusion Criteria:

* Patients with "biopsy proven" Gleason7 prostate cancer referred to Urology and/or Interventional Radiology for treatment
* Surgery and/or Radiation is not a desirable alternative therapy at the time of enrollment
* Tumor size is \< 2 cm at its largest diameter
* Tumor does not encompass the rectal wall or external urethral sphincter
* Patient is able to undergo MRI

Exclusion Criteria:

•
Psychiatric Disorders Related to Diabetes Mellitus Type 1 Among Children in Egypt

Type 1 diabetes is the most common endocrine disorder in children and adolescents. It is characterised by a deficiency in insulin synthesis and requires daily insulin injections to manage glucose levels. Therefore, there are numerous medical approaches to its therapy, such as levels of glycosylated haemoglobin (HbA1c) as a marker of glycaemic control during the last 3 months and monitoring of blood glucose levels, influencing the mental health and the quality of life of the patient and family. Hens, the importance of the psychological adjustment to children and adolescents with type 1 diabetes besides insulin injection, adequate diet and regular exercise rises, in order to maintain stable psychological status and functional mental health, and prevent psychological disorders such as anxiety, depression and sleep disorders. Approaching the comorbidity in these children and adolescents starts with the diagnosis and with the health changes in all aspects.


Eligibility Criteria:
Inclusion Criteria:

1. Both boys and girls aged 6-12 years.
2. Willing of the parents or the caregivers to participate in the study.
3. Duration of type 1 DM of at least 1 year.

Exclusion Criteria:

1. Children with intelligence quotient below 70.
2. Children with history of substance use.
3. Children with another medical or neurological conditions.
Chemotherapy-related Cognitive Impairment and Acute Leukemia

This is an ancillary study of an intervention study (NCT04570709). The parent study is a single institution, feasibility trial of 20 (10 control and 10 intervention) patients with the primary objective of assessing feasibility, acceptability, and change in pre and post measures of symptoms, function, and quality of life by administering the Palliative and Collaborative Care InTervention (PACT). We will further assess cognitive function in the patients who participate in the control of the parent study.

The study objective is to observe patient-reported and researcher-assessed cognitive function in adults with acute myeloid leukemia with chemotherapy treatment. We will assess cognitive function using a battery of neuropsychological assessments, patient-reported questionnaire, and semi-structured interviews among participants in control group only. The group assignment will be conducted through parent study (NCT04570709). Participating in this study will not affect participants' group assignment.

Eligibility Criteria:
\[Patient\]

Inclusion Criteria:

* ≥ 60 years of age
* diagnosis of AML
* Receive 1) low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy OR 2) low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy and any investigational drugs
* have caregiver(s) willing to participate
* participate in the parent study (PACT study, NCT04570709)

Exclusion Criteria:

* referred to hospice care

\[Caregiver\]

Inclusion criteria:

* identified by patient as a caregiver
* ≥18 years of age
* speak and read English
Heterogeneity of Oral Squamous Cell Carcinoma Analysis by Single Cell RNA Sequencing

The goal of this project is to characterise the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and leucoplasic) counterparts by scRNAseq in OSCC patients.

Epidermoid carcinomas of upper aerodigestive tract are the 8th most common cancers in the world. Worldwide, this represents more than 500.000 cases per year and 20.000 cases per year in France (statistics 2018-2020). Among these cancers, oral squamous cell carcinoma (OSCC) are the most common location, leading to significant morbidity and mortality.

OSCC treatment is based on surgery and/or radiotherapy and/or chemotherapy. Immune Check point Inhibitors (ICIs) targeting PD-1 have been approved for recurrent and metastasic OSCC. However, only 15-20% of these patients are treated thanks to this anti-PD-1. Thus, there is a real need to improve the efficacy of ICIs in the treatment of HNSCC. The scRNAseq is a method which allows to study the tumoral heterogeneity, the microenvironment and the dynamic and regulation mecanisms in cells cancer. This technology could improve patient stratification, identify pronostic biomarkers, constitute an important tool in the therapeutical take care and lead to understand tumoral evolution and develop new prevention strategies.

The aim of the study is to characterise the heterogeneity of all cell populations (tumour cells, stromal and immune microenvironment) present in the tumor and their normal (and leucoplasic) counterparts by scRNAseq in OSCC patients.

Eligibility Criteria:
Inclusion Criteria:

* I1. Male or female at least 18 years old.
* I2. Patient with OSCC and undergoing surgery at the Centre Léon Bérard.
* I3. Patient who has agreed to participate in this research and sign consent.
* I4. Patient affiliated to a medical insurance.

Exclusion Criteria:

* NI1. Pregnant or nursing woman.
* NI2. Contraindication to general anesthesia.
* NI3. Suspicion of rare tumor of particular histology other than squamous cell carcinoma (Sarcoma...).
* NI4. Patient under curatorial or guardianship or placed under the protection of justice.
A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression

To see if an extract of green tea can affect certain markers of breast cancer and breast cancer progression in women with a recent biopsy positive for cancer and who are scheduled for surgery.

To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between breast biopsy and surgery in women with recently diagnosed breast cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.

The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective.

1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with breast cancer

1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with breast cancer

1.3 Determine the effects of Polyphenon E on MAPK activation in patients with breast cancer

1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with breast cancer

1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with breast cancer

1.6 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) and Hepatocyte Growth Factor HGF

1.7 Evaluate the safety and tolerability of Polyphenon E in this subject population

Eligibility Criteria:
Inclusion Criteria:

* Definitive biopsy demonstrating primary breast cancer
* Residual breast cancer requiring additional surgical resection
* Stage I, II or III disease
* Patient has ability to give signed informed consent
* Normal hepatic and renal function (creatinine\<1.5, transaminases \<1.5 times upper limit of normal).
* ECOG Performance status of 0 or 1.
* Age ≥ 21 years and less than 75

Exclusion Criteria:

* Prior hormonal or surgical therapy for breast cancer
* Abnormal liver function test
* Liver or kidney problems that would interfere with metabolism of study drug
* Any condition that would hamper informed consent or ability to comply with study protocol
* Participation in another research study in the last three months
* Known malignancy at any site other than breast
* Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
* Allergy or intolerance to any component of green tea
* Inability or refusal to comply with definitive surgical therapy
PAVS in Cardiology

Brief Summary This is a pilot study implemented physical activity assessment, promotion and monitoring in patients. Patients will be assessed by the physical activity vital sign (PAVS) during check-in for their appointment. During their visit with the cardiologist, a clinical decision support tool will alert the cardiologist to patients achieving low (\<50% of recommended) physical activity. The cardiologist may refer the patient to cardiac rehabilitation if appropriate and/or counsel them to increase their physical activity levels. The patients may opt to enroll in the monitoring phase of the study. They will be given a Fitbit pedometer and their Fitbit account can sync to their MyChart account. After that sync, the patients step counts will be available for their cardiologists to review as needed.


Eligibility Criteria:
Inclusion Criteria:

Adult patients in the Center who are age 18 and above will be assessed with the PAVS as part of routine care. To enroll in the home monitoring of PA:

1. Patients must achieve \< 50% of PA recommendations according to PAVS screening questions
2. Have a cellular phone with data plan or a computer to sync Fitbit data
3. Speak English or Spanish
4. Be willing to wear a Fitbit Zip for 3 months

Exclusion Criteria:

1. Adults with a physical disability or medical diagnosis limiting their ability to exercise (e.g. wheelchair bound, aortic stenosis, unstable angina)
2. Planned surgery within three months
3. Those with decisional incapacity therefore unable to comply with study requirements (i.e. related to cognitive deficits or psychiatric diagnosis)
4. Pregnant or breastfeeding women.
Clinical Effectiveness of Microwave Ablation Using Starwave Microwave Generator for Hepatic Malignancies

The purpose of this study is to determine the technical success rate of creating a safety margin of 5 mm or more including the tumor by performing image-guided percutaneous microwave thermal therapy using a microwave generator and antenna developed by StarMed for the treatment of small liver cancer and the 1-year local recurrence rate based on follow-up imaging tests.


Eligibility Criteria:
Inclusion Criteria:

* Child-Pugh Class A or B
* Patients with suspected hepatocellular carcinoma or residual/recurrent hepatocellular carcinoma of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days or Patients with suspected metastatic liver cancer of 4 cm or less on MDCT, CEUS, or MRI performed within the last 60 days, for whom microwave thermal ablation is being considered

Exclusion Criteria:

* In cases where there are three or more malignant liver tumors
* When the maximum size of the tumor exceeds 4 cm
* Diffuse infiltrative type of cancer with unclear tumor boundaries
* When the tumor is adhered to the central hepatic portal vein, hepatic vein, or bile duct by 5 mm or more
* Severe liver failure (Child-Pugh Class C)
* In cases of vascular invasion by malignant liver tumors
* Severe coagulopathy (platelet count below 50,000/mm³ or INR prolonged by more than 50%)
* In cases of multiple extrahepatic metastases
* Situations where it is highly unlikely to obtain appropriate data for research purposes