cyrilzakka/clinical-trials huggingface dataset:
A Registry Study to Observe Clinical Outcomes of Participants With High-risk Metastatic Hormone-naïve Prostate Cancer in Japan

The purpose of this registry study is to longitudinally observe clinical outcomes and patient-reported outcomes (PRO) for participants with high-risk metastatic hormone-naive prostate cancer (mHNPC) in the real-world setting in Japan.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of metastatic, hormone-naïve prostate cancer (mHNPC) after 1 May 2019
* Should have at least 2 of the 3 following high-risk factors: a Gleason score of greater than or equal to (\>=) 8, at least 3-bone lesions, or the presence of visceral metastasis
* Willing to receive androgen-deprivation therapy (ADT) containing regimens for high-risk metastatic, hormone-naïve prostate cancer (mHNPC) in the hospital which have the contract with sponsor for this study, or patient received a regimen containing ADT for high-risk mHNPC
* Possess Japanese nationality
* Each patient (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he understands the purpose of, and procedures required for the study and is willing to participate in the study. For dead cases, the ICF can be waived after approved by Independent Ethics Committee/Institutional Review Board (IEC/IRB)

Exclusion Criteria:

- has any other active malignancies
Effect of Induction and Maintenance of Anesthesia With Etomidate on Hemodynamics and Oxidative Stress in Diabetic Patients

To explore the effect of induction and maintenance of anesthesia with etomidate on hemodynamics and oxidative stress in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years;
* Diabetic patients preparing for elective surgery;
* Body mass index is between 16 and 30 kg/m2;
* Blood glucose is under 8.3 mmol/kg by oral antidiabetic agents or diet control;
* American Society of Anesthesiology (ASA) Physical Status: Ⅰ or Ⅱ;
* Expected operation duration is between 2 and 8 h;
* Signed informed consent form.

Exclusion Criteria:

* Severe cardiac, cerebral, liver, kidney, lung, endocrine disease or infectious disease;
* Chemotherapy or immunotherapy before the surgery;
* Allergy to trial drug or other contraindication;
* Expected or history of difficult airway;
* Suspected abuse of narcotic analgesia;
* Diseases of neuromuscular system;
* Mentally unstable or has a mental illness;
* Trend of malignant hyperthermia;
* Pregnant or breast-feeding women;
* Attendance of other trial past 30 days.
Comparison of the Clinical Response of Total Neoadjuvant Treatment of Two Methods of Long-term or Short-term Chemoradiotherapy in Rectal Cancer

Rectal cancer is one of the most prevalent malignancies in the world, and its prevalence is rising. In more advanced cases neoadjuvant therapy is advised before to surgery, and radiotherapy is one of its cornerstones. For the treatment of rectal cancer, there are primarily two radiation techniques. Long-term radiotherapy is 50.4 Gy delivered in 28 fractions, while short-term radiotherapy is 25 Gy delivered in 5 parts. In earlier studies, these two radiation techniques were combined with various chemotherapy drugs, and a relative comparison was established. Total neoadjuvant treatment, or TNT, has been linked to a better outcome because of the significance of organ preservation. The aim of this research is to compare two TNT radiation techniques with the same regimen of treatment.


Eligibility Criteria:
Inclusion Criteria:

Locally advanced (T3-4, N+)adenocarcinoma of rectum that is located 5 to 15 cm from anal verge .

Exclusion Criteria:

Familial syndromes e.g. lynch Previous history of cancer Previous history of chemotherapy Recurrent disease Metastatic disease Inability to perform MRI (Claustrophobia or prosthetic valve)
Early Changes in Pulmonary Function and Vascular Endothelial Function and the Correlation Between Them in T2DM Patients

Current knowledge: To the best of our knowledge, no studies have reported the correlation between pulmonary function and the vascular endothelial function in diabetic patients during the preclinical period. Indeed, diabetic nephropathy and retinopathy are the leading causes of end-stage renal failure and acquired blindness, respectively. However, when investigators treat patients with type 2 diabetes, investigators seldom consider the pulmonary vascular injury induced by glycemia. Experimental studies have shown that pulmonary function and Vascular endothelial function change during the preclinical stages of diabetic retinopathy. Researchers have already established that compared to healthy subjects, patients with type 2 diabetes have a reduced alveolar gas exchange capacity. The NO and ET-1 can be used to assess the Vascular endothelial function.

What this paper contributes to our knowledge: Regulating glycemia can improve Vascular endothelial function . This study suggests that detecting the NO and ET-1 would allow for the prediction of changes in pulmonary function during the preclinical stages of diabetic retinopathy and the degree of retinopathy in the future.


Eligibility Criteria:
Inclusion Criteria:1) symptoms of diabetes (thirst, polydipsia, diuresis, and unexplainable weight loss); 2) random blood sugar ≥11.1 mol/L, fasting plasma glucose ≥7.0 mol/L or an oral glucose tolerance test outcome (2-hour postprandial blood glucose) ≥11.1 mol/L; or 3) no symptoms of diabetes but either random blood sugar ≥11.1 mol/L or fasting plasma glucose ≥7.0 mol/L.

-

Exclusion Criteria:1) diagnosis of type 2 diabetes according to the guidelines of the American Diabetes Association;11 2) no history of smoking (never smoked), pulmonary disease or pulmonary infection (during the treatment or recovery period); 3) no hepatopathy, nephropathy, or gastrointestinal disease; and 4) a high likelihood of good compliance and the ability to visit our hospital for periodic assessments. The exclusion criteria were as follows: 1) diagnosis of type 1 diabetes; 2) pregnancy and/or active lactation; 3) intensive care with insulin treatment; 4) renal inadequacy, hypohepatia, or heart disease; 5) pneumonia, influenza (during the treatment or recovery period), phthisis or other pulmonary infection; 6) presence of multiple pulmonary cysts, bullae of the lung, or diffuse pulmonary calcifications confirmed via CT; 7) combined diabetic retinopathy and hypertension (for which antihypertensive drugs are used); 8) aneurysm, dissection of aorta; 9) inadequate control of serum lipid parameters by cholesterol-lowering drugs; 10) body mass index ≥32; and 11) the use of systemically injected glucocorticoids within 3 months prior to our study.

-
A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers

The purpose of this study is to evaluate the product performance of a new adjustable compression system for the treatment of venous leg ulcers.

The purpose of this study is to evaluate the product performance of a new adjustable compression system for the treatment of venous leg ulcers. The new compression system consists of a compression stocking and and adjustable compression sleeve. It will be used over primary dressings to provide compression that is beneficial to the healing of venous leg ulcers.

Eligibility Criteria:
Inclusion Criteria:

1. Is the subject 21 years or older?
2. Does the subject have an active venous leg ulceration? If multiple ulcers are present, the investigator will need to select a single ulcer of the study leg that is \> 2cm apart from any other ulcer?
3. Does the subject have an ulcer size between 1cm2 and 12cm2?
4. Does the subject have an ABPI between 0.8 and 1.3 that was taken within the past 28 days?
5. Is the subject ambulatory?
6. Is the subject or family member willing to self-manage the venous leg ulcer therapy at home in collaboration with the medical staff, including the ability to properly readjust the closure straps as indicated by tension indicators, and apply new dressings when needed?
7. Is the subject able to understand questionnaire items and action items (e.g., Subject Diary)?
8. Is the subject willing to give written informed consent, including permission to take photographs of the study leg?

Exclusion Criteria:

1. Does the subject have severe arterial occlusive disease?
2. Does the subject have decompensated heart insufficiency NYHA Class IV, ACC.AHA Stage D?
3. Does the subject have septic phlebitis?
4. Does the subject have severe deep vein thrombosis (phlegmasia cerulea dolens) and other conditions contraindicated according to established guidelines and local procedures?
5. Does the subject have known hypersensitivity to any of the component materials?
6. Does the subject have a suspected clinical infection of the ulcer or any other systemic infection (requiring antibiotics)?
7. Is the subject scheduled for surgery for the ulcer during the 12 weeks following inclusion?
8. Does the subject have a hospital stay planned for the 12 weeks following inclusion?
9. Does the subject have a suspected or confirmed cancerous ulceration?
10. Does the subject have severe peripheral sensitive neuropathy?
11. Is the subject participating in any other prospective study interfering with this study?
12. Does the subject have any medical condition which in the professional opinion of the investigator disqualifies the subject from enrollment into the study?
13. Does the subject have a history of noncompliance to therapies?
Individualized Elective Neck Irradiation Based on MRI in NPC Patients

Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.

Currently, most protocols of nasopharyngeal carcinoma (NPC) of various research bodies such as the Radiation Therapy Oncology Group require routine elective irradiation to the retropharyngeal area and to levels II-V lymph nodal areas regardless of the status of nodal metastasis. Previous studies had confirmed that the pattern of cervical lymph node (LN) metastasis in NPC followed an orderly manner. Retropharyngeal LNs were the most commonly involved, followed by upper neck levels II, III, or VA nodes, and finally to the lower neck nodes including level IV and VB nodes; and the incidence of LN skip metastasis is rare, ranging from 0.5% to 7.9%. It was rare for NPC patients without neck LN metastases to experience neck failure after elective irradiation to levels II, III and VA. It was also confirmed that with unilateral LN metastases of higher-level LNs usually spread down ipsilateral LNs. Thus, the investigators conduct the non-inferior randomized trial to determine the value of elective neck irradiation in NPC patients with unilateral or bilateral uninvolved neck.

Eligibility Criteria:
The eligibility criteria are: newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; with unilateral or bilateral uninvolved neck; aged between 18 and 65 years; Karnofsky performance-status score \> 70; adequate haematological function, with a leucocyte count \> 4 × 109/L, haemoglobin \> 90 g/L, and a thrombocyte count \> 100×109/L.

The exclusion criteria include: previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy; lactation or pregnancy; or severe coexisting illness.
Comparison of Time-Restricted Feeding Versus Grazing

The purpose of this pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the body's ability to control blood sugar and to the health of its blood vessels.

The investigators hypothesize that time-restricted feeding will be more effective at improving glucose tolerance and vascular condition (inflammation and micro- and macro-vascular function) than grazing.

Each participant will eat according to one of the two eating schedules (grazing or time-restricted feeding) for 5 weeks, have a 7-week washout period, and then eat according to the other eating schedule for 5 weeks. Measurements of glucose homeostasis and vascular condition will be performed before and after a participant follows each eating schedule.

Eligibility Criteria:
Inclusion Criteria:

* Are male
* Overweight: Have a body mass index between 25 and 50 kg/m\^2 inclusive (a number calculated from height and weight)
* Are 35-70 years of age
* Have a hemoglobin A1C between 5.5 - 6.4% or prior medical indication of prediabetes
* Have a blood sugar level between 140 and 199 mg/dL two hours after drinking a sugary solution (OGTT)
* Have been eating dinner at least 8.5 hours after eating breakfast at least 90% of the time during the past year
* Have not fasted (go for a day without any food) more than 12 days total during the past year
* Be willing to eat most meals at Pennington Biomedical and/or under supervision
* Not eat any food other than that served by Pennington Biomedical
* Not drink any alcohol, juice, or other beverages that have calories other than what is served by Pennington Biomedical
* Keep water and no-calorie drinks like tea or diet soda the same during both of the timed eating periods
* Be willing to eat your meals according to the fixed schedules

Exclusion Criteria:

* Have diabetes or are on anti-diabetes medication
* Have evidence of cardiovascular disease
* Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
* Evidence of significant gastrointestinal issues or surgery that impacts nutrient absorption
* Regularly use medications such as steroids, beta blockers, and adrenergic-stimulating agents
* Are on any regular medicine that has not had the same dose for 1 month or longer
* Have a clinically significant abnormality as measured by a blood test
* Regularly drink alcohol (more than 2 servings per day)
* Have to do any kind of heavy physical activity
* Currently perform overnight shift work more than one day a week
* Are not able to eat only the food served to you by Pennington Biomedical, while in the study
* Are not able to stop drinking alcohol or other drinks with calories (e.g., soda, juice) other than what is served to you by Pennington Biomedical, while in the study
China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes

The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study in patients with T1D and in pediatric adolescent patients with diabetes who had an age of onset \<= 20 years.

CD1S compromises a retrospective study enrolling inpatients hospitalized from Jan 1st, 2016 to Dec 31, 2021, and a prospective study beginning from the year 2022.

The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study to investigate the demographic characteristics, metabolic control, complications occurrence as well as risk factors of patients with T1D, and to investigate the clinical features, complications' burdens and risk factors in pediatric adolescent patients with diabetes who had an age of onset \<= 20 years.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3)

  1. Clinical diagnosis of type 1 diabetes by a specialist
  2. Age at onset \< 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide \< 200 pmol/L
  3. Initiation and continuation of insulin therapy (except pancreatic or islet transplantation) after diagnosis; positive islet autoantibodies Or 2. Children and adolescents with diabetes mellitus at age of onset \<= 20 years, regardless of type and duration of disease.

Exclusion Criteria:

* For enrolment of patients with T1D, exclusion was made if any of the following criteria were met (not applicable to those with onset under 20 years of age)

  * No insulin dependence for at least 6 months after diagnosis of diabetes mellitus.

    * No DKA for 1 month off insulin for those with a history of diabetes \> 1 year. ③ C-peptide \> 800 pmol/L at any time point.
Topotecan in Treating Patients With Recurrent or Refractory Cancer of the Uterus

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of topotecan in treating patients with recurrent or refractory cancer of the uterus.

OBJECTIVES: I. Estimate the antitumor activity of topotecan in patients with recurrent or refractory carcinosarcoma of the uterus who have failed standard therapy. II. Determine the nature and degree of toxic effects of topotecan in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes daily for 5 days. Treatment repeats every 3 weeks for a minimum of 1 course in the absence of disease progression or unacceptable toxicity. Patients with complete response, partial response, or stable disease continue treatment for at least three courses. Patients are followed every 4 months for 2 years, every 6 months for 3 years, and then periodically thereafter until death.

PROJECTED ACCRUAL: Approximately 25-40 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent or refractory carcinosarcoma (mixed mesodermal tumors) of the uterus Measurable disease

PATIENT CHARACTERISTICS: Age: Not specified Performance Status: GOG 0-2 Life Expectancy: Not specified Hematopoietic: Platelet count at least 100,000/mm3 Absolute granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance greater than 20 mL/min Other: No invasive malignancies within the past 5 years except nonmelanomatous skin cancer No significant infection

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior topotecan or camptothecin therapy No more than 1 prior chemotherapy regimen (either single or combination chemotherapy) Endocrine therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Prior surgery allowed and recovered
Single Session Consultation for Parents

Single-Session Consultation (SSC) is a rapidly provided, low-intensity, goal-directed counseling service used for treatment of diverse mental health problems. Research on SSC suggests that, for some clients, a single session of counseling (60 minutes) may help reduce clinical distress.

Despite its benefits, SSC has yet to be evaluated as an alternative for parents (18+) of school-age children (5-12 years old) in the United States with elevated stress levels.

The current research aims to evaluate SSC's feasibility, acceptability, and efficacy as an intervention for this population.

First, perceived acceptability (i.e., parents' participation and successful completion, reschedules, and/or cancellations), usefulness, and client satisfaction will be examined. The investigators will also evaluate whether mechanisms of change (e.g, hope, agency), parental (e.g, stress, mental health), and child (e.g, behavior) outcomes, are improved following the SSC.

The investigators expect SSC to be acceptable, for clients to find SSC to be useful, to be satisfied, and experience an increase in hope and agency after the SSC and hypothesize a reduction in stress levels and improvement in mental health among parents. However, the investigators believe behavior outcomes for the child will remain unchanged.

The investigators will recruit parents via online advertisement on social media. Potential participants will complete a screener through Qualtrics to determine eligibility, which includes location in the United States, age (18+), child's age (5-12 years old), preferred language, child's legal guardianship, technology access, and stress levels. Once eligible, participants will provide consent and make an appointment for their SSC.

The 60-minutes-session will be conducted using HIPAA complaint NYU Zoom with Study Consultants. Parents will complete assessments of parental stress, parental mental health, and child behavior to assess mechanisms (i.e., hope, agency) outcomes and measures of usefulness and satisfaction prior and post the SSC, and another 2-week follow-up questionnaire to monitor progress.

Sessions will be recorded for supervision and treatment fidelity purposes. Upon completion, parents will receive an Action Plan, a written record of the discussion, recommendations, and resources.


Eligibility Criteria:
Inclusion Criteria:

1. Adult parents (18+ years old) who are legal guardians of their school-age children (5 to 12 years old)
2. Must have elevated stress levels based on validated measures obtained through parent self-report
3. Parent must reside in the United States
4. Must be English dominant
5. Can access video-based Zoom conference

Exclusion Criteria:

1. Parent has significant cognitive delays that prohibit involvement in SSC
2. Parent expresses significant personal mental health challenges/child abuse during SSC that warrant immediate discontinuation from SSC.
Study to Evaluate the Efficacy, Safety and PK of Intravenous Single Injection LC28-0126 Immediately Before PCI in STEMI Patients

Evaluate the efficacy, Safety and Pharmacokinetics of Intravenous single injection LC28-0126 immediately before Percutaneous Coronary Intervention (PCI) in Patients with ST-segment Elevation Myocardial Infarction (STEMI).


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 and 75
* Within 12 hours after the onset of chest pain
* ST-segment elevation of more than 0.1 mV in two contiguous leads or new left bundle-branch block (LBBB) patients
* Signed for written informed consent

Exclusion Criteria:

* Left Main disease
* Multi-vessel disease
The Study of the Phenotype of Hereditary Xerocytosis

Hereditary xerocytosis is a dominant red blood cell membrane disorder characterized by an increased leakage of potassium from the interior to the exterior of the red blood cell membrane, leading to water loss, red cell dehydration, and chronic hemolysis. In 90% of cases, it is associated with heterozygous gain-of-function mutations in PIEZO1, a gene that encodes a mechanotransducer responsible for converting mechanical stimuli into biological signals. The remaining 10% of cases are linked to mutations in the GARDOS channel gene.


Eligibility Criteria:
Inclusion Criteria:

* Any patient diagnosed with hereditary xerocytosis according to the 2021 PNDS guidelines
* Covered by a social security plan
* Signature of the consent form for study participation by the patient, or for minors, by the parent(s)/legal representative(s).

Exclusion Criteria:

* patients with other hemolysis reason