cyrilzakka/clinical-trials huggingface dataset:
Transcriptome Analysis in Idiopathic Nephrotic Syndrome: Steroid Responsiveness

Idiopathic nephrotic syndrome (INS) affects the glomerular barrier by damaging the podocytes with foot process effacement, leading to a pathological increase of permeability and protein loss. INS classification is based on the clinical response to glucocorticoid (GC) therapy. When GCs treatment fails to induce remission in a four-six weeks course, patients are defined as affected with steroid-resistant nephrotic syndrome (SRNS).

The whole transcriptome sequencing could consent the INS classification at onset, prior to glucocorticoids (GCs) treatment, allowing to reduction of unuseful GCs treatment. RNA sequencing technologies allow an extensive characterization of the transcriptomic profile and permit global changes in gene expression levels between different conditions such as active and remission of the disease.

Of great interest is the research of a molecular biomarker to predict steroid resistance, a predictor that is not yet available. Among the candidate biomarkers, pharmacogenomic determinants are promising, even if available studies are still limited. Among these, some epigenetic factors have been previously suggested. Data obtained in animal models suggests that nucleotide-binding oligomerization domain-like receptors (NOD-like receptor) pyrin domain containing 3 (NLRP3) inflammasome can be deregulated in a wide variety of glomerular diseases, including those causing INS. Another potential marker involved in steroid response is the long noncoding RNA GAS5. Data reported in the literature indicate that abnormal levels of GAS5 in peripheral blood mononuclear cells (PBMCs) may alter steroid effectiveness in autoimmune diseases, such as inflammatory bowel disease.

Preliminary findings show that the study of NLRP3 promoter methylation could be reduced in the blood of SRNS compared with steroid-sensitive nephrotic syndrome (SSNS) patients. Moreover, unpublished encouraging results on the association between Growth Arrest Specific 5 (GAS5) expression and steroid response in INS in PBMCs were obtained in a preliminary study conducted on 8 patients with the first episode of INS. PBMCs were obtained and GAS5 gene expression was evaluated using TaqMan technology. Patients affected with SRNS presented significantly higher levels of GAS5 in comparison with the SSNS group. In PBMCs from SRNS patients, the GAS5 expression could reduce the availability for binding to GCs target genes of the activated GCs receptor and suppresses GC transcriptional activity.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of INS
* age 1 - 12 years
* signed informed consent by parents or legal guardians
* For controls: aged-matched individuals with Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)

Exclusion Criteria:

* Patients aged \<1 year or \> 12 years
* Patients diagnosed with a secondary or genetic form of NS
* For controls: the presence of coexisting chronic kidney failure, autoimmune or autoinflammatory disease, or endocrinologic disorders.
Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting

This is a collaborative study that will provide a comprehensive source of observational data that can be used to obtain real world evidence of ASD. The study will contain demographic and observational clinical data for eligible participants. All decisions regarding patient care will be determined by the ECHO Autism Clinician (EAC). All clinical outcomes will be assessed by the EAC as would occur in routine clinical practice.

The study will be conducted by the University of Missouri ECHO Autism Communities Research Team (RT). Research participants recruited by the RT will include: 1) University of Missouri ECHO Autism Community trained clinicians (EACs) in both rural and suburban areas across the United States; 2)Caregivers/Patients with a suspicion of autism. Caregivers/Patients with a suspicion of autism and EACs will complete the informed consent process prior to entering the study. Once enrolled, EACs will provide routine clinical care and conduct best-practice ECHO Autism diagnostic evaluations with the addition of Canvas Dx to patients who have a suspicion of autism spectrum disorder. Canvas Dx will be prescribed; the caregiver will download and access the diagnostic app with a code. The caregiver will then complete the following activities:

* Complete Caregiver Questionnaire in the mobile app
* Upload two 90 sec to 5-minute videos of the participant through the mobile app

Eligibility Criteria:
Inclusion Criteria:

1. English is spoken proficiently by the participating patient/family, in the opinion of the EAC.
2. Meets labeling of device
3. Parent, guardian, or legally authorized representative (LAR) must be able to read, understand, and sign and date the Informed Consent Form (ICF)
4. Sex assigned at birth (Female or male or non-binary)
5. Female or male, \> 18 to \< 72 months of age
6. Caregiver, HCP or community-based professional concern for developmental delay or Autism
7. Parent/guardian/LAR must have smartphone utilizing the most recent and previous version of iOS and Android operating systems (iOS 13 or 14; Android 10 or 11, excluding Android Go)
8. Participants must be willing to be videotaped as part of the device input

Exclusion Criteria:

1. Participants with a prior diagnosis of Autism Spectrum Disorder (ASD) rendered by a healthcare professional
2. Participants with any other medical, behavioral, or developmental condition that in the opinion of the ECHO Autism Clinician may confound study data/assessments
3. Participants whose age on the date of enrollment is outside the target age range
4. Participants or caregivers who have, to the best of their knowledge, been previously enrolled in any Cognoa clinical study or survey
Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than or equal to 18 years of age
2. Karnofsky Performance Status of greater than or equal to 60
3. FIGO Surgical Stage I, II, and III
4. Pathologic confirmation of endometrial cancer
5. Patient status post hysterectomy
6. Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases
7. Patients must have adequate:

   * Bone Marrow Function:

     * ANC ≥ 1,500/mcl (\< CTCAE v 3.0 Grade 1).
     * Platelets ≥ 100,000/mcl (\< CTCAE v3.0 Grade 1).
   * Renal Function:

     * Serum creatinine ≤ institutional upper limit normal (ULN) (CTCAE v 3.0 Grade 0). Note: if serum creatinine \> ULN, a 24-hour creatinine clearance must be collected and must be \> 50 mL/min.
   * Hepatic Function:

     * Bilirubin ≤ 1.5 x ULN (\< CTCAE v 3.0 Grade 1).
     * SGOT≤ 2.5 x ULN (\< CTCAE v 3.0 Grade 1).
     * Alkaline phosphatase ≤ 2.5 x ULN (\< CTCAE v 3.0 Grade 1).
   * Neurologic Function:

     * Neuropathy (sensory and motor) \< CTCAE v 3.0 Grade 1.

Exclusion Criteria:

1. Age less than 18 years of age
2. Karnofsky Performance Status less than 60
3. Radiographic or pathologic evidence of metastatic disease (other than pelvic or para-aortic lymph nodes)
4. Prior pelvic radiation therapy
Presence or Absence of Blood in the GI Lumen

Bleedings in the upper digestive tract are common. Usually, laboratory and clinical parameters are considered to establish a suspicion for a bleeding in the digestive tract and to estimate urgency of the situation. If these parameters suggest the presence of a bleeding in the digestive tract, endoscopies are often performed to further investigate a patient's status. The above-mentioned laboratory and clinical parameters are sometimes not specific enough to reliably identify a bleeding in the upper digestive tract. The HemoPill acute is capsule device, that has a built in sensor that detects blood in the upper digestive tract. This information is valuable for the medical personnel and complements the information that is obtained from other laboratory or clinical tests

The purpose of the study was to access safety and accuracy of Hemopill and its receiver. Patients scheduled for endoscopy on the basis of suspected UGIB are generally eligible for inclusion into the trial. After patient screening, information and obtaining informed consent, a patient is enrolled into the trial. Shortly before the scheduled endoscopy is performed, the patient ingests a HemoPill acute. Endoscopy is performed as scheduled. Blood within the GI lumen is identified if present and pictures are taken. Pathologies, if found, are treated as per clinical standard. The HemoPill acute measurement regarding presence or absence of blood in the GI lumen is compared to observations made during endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for endoscopy due to suspicion of UGIB based on clinical and / or laboratory findings
* Signed informed consent
* Age ≥ 18 years
* Willingness and ability to participate in the study procedure

Exclusion Criteria:

* Contraindications to the use of the HemoPill acute, such as:
* Known gastrointestinal obstruction, stricture, fistula, or diverticula
* Dysphagia or other swallowing disorders
* Pregnancy
* Incapacity to provide informed consent
* In patients with cardiac pacemakers and other implanted medical devices
Identifying Right Ventricular Dysfunction in COPD Through Right Heart Catheterization, Imaging and Exercise

This study plans to learn more about heart function among individuals with chronic obstructive pulmonary disease (COPD). In particular, the investigators want to understand the different patterns of right ventricular response to pulmonary hypertension (high pressure in the lungs) during rest and exercise. By identifying patterns of right ventricular dysfunction, this study will help identify better treatments for patients with COPD in the future.


Eligibility Criteria:
Inclusion Criteria:

* COPD (determined by ratio of forced expiratory volume in 1 second to forced vital capacity \[FEV1/FVC\] \<0.7) • Pulmonary artery enlargement determined by pulmonary artery-to-aorta ratio \>1 or \>30 mm on most recent CT

Exclusion Criteria:

* Exacerbation of COPD or use of systemic corticosteroids in the 3 months prior to enrollment
* Change in COPD therapy in the 3 weeks prior to enrollment
* Requirement of \>6 LPM supplemental oxygen at rest
* Requirement of \>10 LPM with exertion
* Active/uncontrolled cardiovascular disease (e.g. hypertension with blood pressure \>150/100 despite antihypertensives; coronary artery disease with angina; left ventricular ejection fraction ≤40%; arrhythmia; pulmonic, mitral or aortic valvular abnormality greater than mildin severity; tricuspid regurgitation greater than moderate in severity; diabetes with HbA1c \>8.5%)
* Volume overload (jugular vascular distension or greater than trace peripheral edema)
* Interstitial lung disease
* Untreated severe obstructive sleep apnea
* Active malignancy
* Medical conditions that limit exercise on an upright stationary bicycle (e.g. osteoarthritis, etc.)
* Pregnancy
* Body mass index \<18 or \>35
* Hematocrit \<25% or \>55%
* For optional Part 2 i.e. exercise training and Visit 2, residence \>90 miles from University of Colorado Anschutz Medical Campus or unwillingness/inability to attend exercise training sessions for approximately 35 minutes 3x/week for 12 weeks
* For optional Part 2 i.e. exercise training and Visit 2, already engaged in routine exercise training (\>30 minutes at \>3 METs 3 times/week or more)
The Effects of Whey, Rice and Potato pRotein isOlates on appeTite rEgulatIoN in Healthy Men

INTRODUCTION: Global protein consumption has been increasing for decades due to changes in socio-economic demographics and consumer trends towards higher protein intake, which may be related to their health benefits in performance nutrition and appetite regulation. The additional intake of protein often occurs in the form of supplements. One of the main ingredients used in sports and weight loss supplements are animal-derived proteins such as whey, which are of high quality, containing all the essential amino acids required in human nutrition with a high absorption rate. However, whey protein has a high environmental footprint, and it may contribute to insulin resistance in susceptible groups (e.g. obese, T2DM, insulin resistant, or those with sarcopenic obesity).

Rice and potato protein isolates are high-quality plant proteins containing all essential amino acids comparably to whey protein. These plant-derived proteins may provide a more sustainable and accessible alternative to animal-derived proteins for appetite regulation and weight management.

Intervention study with three treatment groups in a randomised, single-blind, triple crossover design.

Study population: Healthy male participants will receive three different isocaloric and -volumetric protein shakes prepared using whey, rice and potato protein powders on different trial days with at least a one-week washout period apart.

Biological samples (blood and saliva samples) are collected at various time points during the visit. Blood samples are collected at baseline 10 min prior (T-10), then at 30 min (T30), 60 min (T60), 120 min (T120) and at 180 min (T180) after protein shake consumption. Saliva samples are collected at baseline (T-10), then at every 30 minutes following protein shake consumption (T30, T60, T90, T120, T150, T180). In addition, pertinent questionnaires Visual Analogue Scale \[VAS\] for the assessment of satiety and VAS for the assessment of protein shakes' perception will be collected at T-10, T30, T60, T90, T120, T150, T180 and at T0, respectively

Eligibility Criteria:
Inclusion Criteria:

* Males (18-65 years of age)
* Healthy subjects

Exclusion Criteria:

* \<18 years or \>65 years
* Consumption of \>21 units of alcohol/week
* Dieters
* Any allergies/health issues related to items being ingested
* Any serious illnesses or those on medication
* Any illness affecting taste or appetite
* Any gastrointestinal disorders
* Any eating disorders
* Any depression/mental disorders
* Smoking
Examination of Textile Solutions for Reducing Physiological Stress

Using protective or combat garments under heavy heat stress conditions, during rest or exertion, may hinder the body's ability to effectively exchange heat with the environment and thereby can lead to heat injuries. The purpose of this research is to physiologically examine the new textile solutions that are planned to be integrated in the protective garments, combat garments and work uniforms in the army, by evaluating the physiological stress obtained during exertion under hot climatic conditions.

10 young, healthy civilian volunteers will participate in this study. After reading and signing an informed consent form, all subjects will undergo medical examination which includes ECG, anthropometric measurements and Vo2max test. Afterwards, the subjects will perform 6 acclimatization days carried out by the standard protocol of Heat Tolerance Test (HTT). After acclimatization, the subjects will undergo 4 experiment days under heavy heat stress in a climatic chamber, dressed in each experiment day with one out of 4 clothing combinations (NBC protective garment \[charcoal base\], combat garment and 2 different types of work uniforms). Physiological stress will be evaluated from rectal temperature and heart rate measurements.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-30 years.
* Healthy civilian volunteers.
* Without known medical illness or medication use.

Exclusion Criteria:

* The existence or suspicion of existing cardiac or respiratory disease.
* Hypertension.
* Diabetes.
* Psychiatric condition.
* Any muscles or skeledon condition.
* Any hormonal disease or any other chronic illness that may inhibit participation in the experiment.
* Infectious disease 3 days prior to the experiment.
Prostaglandin E1 in Outpatients With Intermittent Claudication

Investigate, under outpatient conditions, both the effect of 4 weeks of daily treatment with Prostaglandin E1 and that of 4 weeks of interval treatment (two infusions per week) on the pain-free walking distance in patients with Intermittent Claudication.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Peripheral Arterial Occlusive Disease (PAOD) of the lower extremity in Fontaine stage II
* Maximum walking distance on the treadmill (12 %, 3 km/h) between 30 and 150 m
* Stable Intermittent Claudication of at least 6 months standing with no acute shortening of walking distance over the past 3 months
* Stenoses or occlusions below the Femoral Bifurcation (above-knee or below-knee type) confirmed by duplex US or angiography
* Ankle/brachial index ≤ 0.90 with a decrease in systolic ankle pressure of ≥ 10 % after maximum loading (maximum walking distance on the treadmill at 3 km/h, 12 %)
* The patient is physically and mentally capable of participating in the trial
* Patient age \> 40 years, male and female
* Patient is informed and given ample time and opportunity to think about her/his participation and has given her/his written informed consent
* Patient is willing and able to comply with all trial requirements

Exclusion Criteria:

* Surgical or other interventional measures performed on the affected extremity and Prostaglandin treatment within the 6 months immediately prior to the trial
* Rest pain and Necroses
* Systolic ankle pressure less than 50 mmHg
* Change in maximum walking distance during the one-week Run-in Phase of more than ± 25 % of Baseline
* Successful physical walking training within the 6 months immediately prior to the trial
* Inflammatory vascular diseases
* Polyneuropathy in Diabetes Mellitus
* Diseases limiting walking distance (Arthrosis, inflammatory diseases of the joints, neurological disease, diseases of the Vertebral Column, cardiopulmonary diseases)
* History of Pulmonary Oedema
* Myocardial infarction within the past 6 months
* Pregnancy or nursing
* Known hypersensitivity to any components of the trial medication or comparative drug
* Renal insufficiency, compensated retention (creatinine \> 2.0 mg/dL)
* Severe retinal Haemorrhage
* Massive Haemorrhage
* Known existing malignant diseases
* Vasoactive concomitant medication (e.g. Naftidrofuryl, Pentoxifylline, Buflomedil, Cilostazol), or other Prostaglandins
* Untreated or uncontrolled Hypertension (systolic blood pressure ≥ 180 mmHg, diastolic blood pressure ≥ 110 mmHg)
* Previous participation of the patient in the present trial
* Participation of the patient in a trial with the same objectives within the past 6 months, or is currently participating in another trial
* Illness of the patient due to alcohol or drug-abuse within the past 6 months
* Serious illness of the patient that the investigator considers to compromise his/her participation in the trial
Clinical Study of Light Therapy to Control Myopia Progression in Children

Low-lever red light therapy (LLLT) has been used to control myopia progression in China for a few years besides amblyopia therapy for a few decades. This study is to test the efficacy of PBM therapy to myopia children as well as to compare two types of PBM therapy to control myopia progression within one month.

LLLT utilized the 650-nm red light to provide sufficient energy to stimulate the tissue without causing damage to the surrounding tissues. And several researchers reported the long-term efficacy of LLLT in slowing the progression of myopia to date. These studies were reported various illumination and irradiance. This study is to test the efficacy of LLLT comparing to the control group as well as to test whether two types of lighting design will be different to the efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

1. Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is not limited;
2. Equivalent sphere (SER): -0.50D \~ -6.00D (including-0.50 and-6.00D);
3. Best corrected vision in one eye under glasses correction: 0.1 log MAR;
4. No strabismus: no more than 15 prism constant dominance strabismus after far and near cover tests;
5. No myopia control measures within the previous 4 weeks: such as orthokeratology lens, gradient lens, double light lens, eye drops for myopia control (such as atropine), myopia defocus glasses, red light for myopia control, other specially designed myopia light treatment instruments or contact lenses for special design to control myopia (such as Misight);

Exclusion Criteria:

1. Any ocular(including constant dominant strabismus with more than 15 prisms) and systemic diseases or abnormalities can significantly affect visual function or promote the progression of myopia;
2. Other interventions for myopia control before 4 weeks before enrollment, For example, orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control, other specially designed comprehensive treatment devices, myopia, amblyopia, or specially designed contact lenses (such as Misight), etc.
3. Subject participated in other clinical trials within 4 weeks before the enrollment;
4. The investigator for safety reasons or the interests of the patient, Other circumstances in which the patient should not participate in this trial, If suffering from serious heart, liver and kidney disease. -
A Retrospective Study on the Relationship Between Donor Leukocyte Telomere Length and Prognosis of Acute Leukemia Patients Treated With Allogeneic Hematopoietic Stem Cell Transplantation

This post hoc analysis included patients with acute leukemia who underwent allo-HSCT at the First Affiliated Hospital of Zhejiang University School of Medicine and Ruijin Hospital Shanghai Jiaotong University School of Medicine. Patients and their donors were assessed for eligibility to join this study. The inclusion criteria were: (1) age ≥ 5 years; (2) diagnosis of acute leukemia including acute myeloid leukemia, acute lymphocytic leukemia, and mixed phenotype acute leukemia; (3) patients attained complete remission (CR) and achieved full engraftment with 100% donor chimerism following allo-HSCT; (4) telomere testing was conducted on peripheral leukocytes of donors before granulocyte colony-stimulating factor (G-CSF) mobilization, and the results were obtained. Written informed consent was obtained from all included patients and their donors, and the study was conducted in compliance with the Declaration of Helsinki. Ethical approval was approved by the ethics review committee of the First Affiliated Hospital of Zhejiang University School of Medicine.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 5 years
* First allo-HSCT from matched related, unrelated, or haploidentical donors
* Achievement of complete remission after allo-HSCT
* Donor blood sample collection before granulocyte colony-stimulating factor mobilization

Exclusion Criteria

* Non-acute leukemia diagnoses, including acute myeloid leukemia, acute lymphocytic leukemia, and mixed phenotype acute leukemia
* Failure to achieve engraftment with full donor chimerism after allo-HSCT
* Inability to extract DNA for telomere length analysis.