cyrilzakka/clinical-trials huggingface dataset:
Protein Molecular Characteristics and Prognosis of Cervical Neuroendocrine Tumors

The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, TCT results, and colposcopy biopsy pathology results. At the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. Protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value.

1. The clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were used for prognostic analysis.

(1) The diagnosis and treatment information of cervical neuroendocrine carcinoma in multiple hospitals was collected, including clinical and medical data such as age, preoperative HPV genotyping, preoperative biopsy pathological results, postoperative histopathological results, FIGO staging, prognosis and survival information, and follow-up of patients.

2. Protein and other omics analysis was performed on paraffin tissues of 100 cases of cervical neuroendocrine tumors Paraffin samples collected from 100 cases of cervical neuroendocrine tumors were identified, processed and segmtioned, and protein concentration and proteome were determined to establish the molecular characteristics and prognostic targets of cervical neuroendocrine tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with cervical neuroendocrine carcinoma by histopathology
2. Clinical data were complete

Exclusion Criteria:

1. Patients who are not being treated in our hospital
2. Patients with lack of follow-up data, unable to obtain survival information
3. Patients call to refuse to participate in this project
4. The quality of paraffin specimens can not meet the requirements of proteome concentration determination
Evaluation of Correlations Between Volatile Organic Compounds and Venous Blood Glucose in Subjects With Type 2 Diabetes

The goal of this study is to evaluate correlations between VOCs in the breath and venous blood glucose values in various glycaemic states in people living with Type 2 Diabetes. VOCs are measured with a gold-standard GC-IMS device and a prototype of a novel breath analyzer. Participants will be exposed to different blood glucose levels at different rates of change by administering glucose solution and insulin and by a meal challenge.

The research project aims to expand the understanding of correlations between VOCs in the breath and venous blood glucose levels in non-insulin-dependent people with Type 2 Diabetes. To better understand correlations, the subjects are exposed to hyperglycaemic, euglycaemic and hyposglcycaemic states at different rates of change by applying a hand clamp procedure, and the VOCs are compared after a standardized meal and the same excursion by applying a hand clamp procedure. Inter- and intraparticipant variability as well as the timing of changes in the VOC spectra compared to changes in the glucose values are of interest. Secondarily, the feasibility of estimating glycaemic states with a prototype of a novel breath analyzer is being investigated.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* T2D treated with one or more oral anti-diabetic drugs (incl GLP-1 and/or GIP)
* 10 years since T2D diagnosis
* HbA1c ≤8% (HbA1c based on last measurement by treating physician but not older than 120 days)
* Willingness to undergo study procedures
* Age 45 -70 years (inclusive)

Exclusion Criteria:

* Pregnancy and/or lactation period
* Currently on chronic or occasional treatment with pulmonary drugs
* Insulin dependency
* Smoking (last cigarette within the last six months)
* BMI above 30 kg/m²
* Lp(a) above 125 nmol/l
* LDL not in the individual target range of an earlier cholesterol goal according ESC guideline 2021 (LDL based on last measurement by treating physician but not older than 30 days)
* Irregular 12-lead ECG or increased carotid plaque burden based on a three-point sonography. Both examinations are performed and evaluated according to the investigator's judgment.
* History of, or manifested, cardiovascular diseases
* Medical history of epilepsy or other neurological disease associated with seizure events
* Known sensitivity to medical grade adhesives
* Comorbidities that are suspected to alter the VOC spectra
* Participation in another investigation with an investigational drug within the 30 days preceding and during the present investigation
* Not able to understand, write or read German
Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects

The primary objective of this study is to determine the pharmacokinetics (PK) of Clascoterone Cream, 1% after single dose and repeat dose topical administrations in healthy Chinese adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Chinese adult subjects, male or female;
* 18-45 years of age (18 years old and 45 years old are inclusive, on the day of signing the written informed consent);
* Males should be ≥50.0 kg females should be ≥45.0 kg, respectively, and their body mass index \[BMI = weight (kg)/height2 (m2)\] should be within the range of 19.0 to 28.0 kg/m2 (including critical value);
* Female subjects of childbearing potential or male subjects whose partners are of childbearing potential should agree and be able to use effective contraception from the time of signing the written informed consent to within 3 months after the last dosing (see Appendix 2 for details);
* Subjects should be able to communicate well with the investigator and complete the study as per the protocol; subjects should be fully informed about the study and sign a written informed consent voluntarily.

Exclusion Criteria:

* Subject has a previous history of chronic or serious disease;
* Subject who has undergone major surgical procedure or procedure affecting drug absorption, distribution, metabolism, or excretion within 6 months prior to screening, or plans to undergo surgery during the study;
* Subject has a history of drug abuse and drug dependence;
* Subject who has received any medication prior to screening;
* Subject has previous allergies or has allergic symptoms;
* Subject has skin damages;
* Subject who has consumed alcohol regularly;
* Subject has positive testing result of drug abuse and narcotics screening ;
* Subject who has consumed excessive of strong tea, coffee, or caffeine-containing beverages;
* Subject who has been addicted to smoking;
* Subject who has intake of grapefruit-rich beverages or foods;
* Subject who has participated in a clinical study with another drug or device and has used the drug or device prior to screening
* Subject who has donated blood or bled heavily , or received a blood transfusion or used blood products; or who plans to donate blood or blood components;
* Subject has abnormal physical examination result at screening, or abnormal result of vital signs, or abnormal ECG findings;
* Subject has abnormal and clinically significant results of clinical laboratory tests;
* Subject who is a pregnant or lactation woman or has positive pregnancy test result;
* Subject who is unable to follow a uniform diet;
* Subject who has difficulty in collecting blood, has a history of needle and blood fainting or cannot tolerate venipuncture;
Study for the Early Diagnosis of Parkinson's Disease

The main objective of the study is to design and validate the blood based PDx gene expression and miRNA assay for the early diagnosis of Parkinson's disease patients. Differential diagnosis includes patients with Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia, Essential Tremor and Normal Controls.

In this study, the PDx assay will be designed and validated in order to distinguish between Idiopathic Parkinson's disease (PD) to patients with similar symptoms and healthy controls. The differential diagnosis cohort includes patients diagnosed with Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD), Essential Tremor (ET) or Lewy Body Dementia (LBD) and Healthy Controls.

This is a prospective observational study. Blood samples and clinical data will be collected at the first and only study visit. The expression levels of 5 to 6 genes will be analyzed by blinding technicians concerning the diagnosis, demographic data and clinical data, which will be revealed after sending PDx gene expression values to the clinical sites. The gene expression levels will be compared between Parkinson's disease patients to the differential diagnosis cohort and healthy controls. Additional mRNA and miRNA markers will be explored. The primary aim of the study is to design and validate a clinical classifier that will aid the physician in the diagnosis of Parkinson's disease patients. The analysis will be performed in two stages: Stage 1) Exploration analysis and Stage 2) Validation. After one year of taking a blood sample, the study physician will contacted to confirm the patient's diagnosis.

Blood samples will be collected at specialized movement disorder clinics.

Medical history, clinical diagnostic features, family history in regard to Parkinson's disease, use of medication and routine imaging assessment (not mandatory) will be collected at the first and only patient visit.

Eligibility Criteria:
Inclusion Criteria:

* Patient is able and willing to read the informed consent form
* Patient with clinical diagnosis of Idiopathic Parkinson's Disease according to Queen Square Brain Bank Criteria up to one year prior to enrollment in study
* Patient with diagnosis of MSA, PSP, CBD, Lewy Body Dementia, Essential Tremor or Healthy Control
* Men and Women aged 40-80 years
* Willing and able to comply with procurement of blood sample

Exclusion Criteria:

* Any medical, psychiatric or other conditions which, in the opinion of the investigator, would preclude participation
* Pregnancy
Accelerated Enhanced RECOVERy Following Minimally Invasive Colorectal Cancer Surgery (RecoverMI)

The goal of this clinical research study is to learn if RecoverMI care can help to shorten the time that patients are in the hospital after surgery and if it can help them recover sooner.

RecoverMI includes the following parts:

* Preoperative Education
* Early oral intake
* Early mobilization
* Telemedicine

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one group is the same, better, or worse than the other group.

* If you are assigned to Group 1, you will receive standard enhanced care after your surgery.
* If you are assigned to Group 2, you will receive routine care after surgery, but you will also receive accelerated recovery, early discharge, and Telemedicine. Participants will be loaned an iPad to use for video-conferencing and text messaging in this study.

This is an investigational study. The study doctor can explain how RecoverMI is designed to work.

Up to 32 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has histologically proven colorectal cancer or polyp(s) that is planned to be treated by surgical resection performed with curative intent.
2. Patient is \>/= 18 years and younger than 80 years.
3. Elective minimally invasive operation.
4. No planned ostomy creation at time of enrollment.
5. Serum creatinine \<1.5 measured within 30 days of surgery.
6. Ability to speak, read, and understand English.

Exclusion Criteria:

1. Strong, self-reported history of postoperative nausea and vomiting.
2. History of congestive heart failure. Systolic heart failure defined as Ejection Fraction (EF) \</= 40%), or diastolic heart failure defined as EF \>40% PLUS systemic manifestation of heart failure.
To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis

To Evaluate the Efficacy and Safety of Levocetirizine Versus Loratadine for Treatment of Seasonal Allergic Rhinitis


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 60 years old, inclusive
* two-year history of allergic rhinitis due to tree, grass or weed pollen
* sufficient histamine-dependent symptoms of rhinitis during the selection week (T5SS ≥ 5)

Exclusion Criteria:

* An ear, nose or throat (ENT) infection
* asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
* atopic dermatitis or urticaria requiring an antihistamine or corticosteroid treatment
* an associated ENT disease
* use of decongestants
* nasal or ocular topical treatment
Impact of Disease Activity and Nutrition Treat on Postoperative Recurrence and Complications After Bowel Resection for Crohn's Disease

The study was aimed to determine whether perioperative nutrition treat and(or)the perioperative disease activity were associated with postoperative recurrence and complications after bowel resection for Crohn's disease.

The investigators want to assess the impact of possible risk factors on intestinal resection and postoperative recurrence in Crohn's disease (CD) and to evaluate the disease course.

In our clinical treatments, the investigators found that perioperative CDAI and nutrition treatment may have same impact on postoperative recurrence and complication in Crohn's disease. The investigators design this study to test it.

The study prepare to collect the clinical data of patients who need bowel resection for CD to analyzed. The investigators divide those patients into two groups (N,I group). They accept intestinal nutrition with the respective aim that get the inflammatory index (erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Crohns Disease Activity Index (CDAI)) norm or nutritional index norm before they accept surgery. Postoperative recurrence and complications in patients will be recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

Patients had a CRP level of more than 8mg/L Patients had a preoperative weight loss \>5% over the past 6 months and had a serum albumin of less than 35g/L at the enrollment
Melody Transcatheter Pulmonary Valve (TPV) Post-Market Surveillance Study

This non-randomized, prospective, interventional observational multi-center study is designed to assess the long-term clinical performance of the Medtronic Melody™ Transcatheter Pulmonary Valve (TPV) in the post market environment over a period of five years after transcatheter implantation in patients with dysfunctional RVOT conduits. In addition, the quality of life of implanted subjects will be assessed over five years.


Eligibility Criteria:
Prospective subjects have complex congenital heart defects that have been palliated with RVOT conduits that have become dysfunctional and have a clinical indication for invasive intervention. Prospective subjects must meet all of following inclusion and exclusion criteria:

Inclusion Criteria:

* Age greater than or equal to 5 years of age
* Weight greater than or equal to 30 kilograms
* Existence of a full (circumferential) RVOT conduit that was equal to or greater than 16 mm in diameter when originally implanted
* Any of the following by transthoracic echocardiography

For patients in NYHA Classification II, III, or IV:

* Moderate (3+) or severe (4+) pulmonary regurgitation, or
* Mean RVOT gradient greater than or equal to 35 mmHg.

For patients in NYHA Classification I:

* Severe (4+) pulmonary regurgitation with RV dilatation or dysfunction, or
* Mean RVOT gradient greater than or equal to 40 mmHg.

Exclusion Criteria:

* Active endocarditis
* A major or progressive non-cardiac disease (e.g. liver failure, renal failure, cancer) that results in a life expectancy of less than one year
* Patient or - for patients who cannot legally give consent themselves- the guardian unwilling or unable to provide written informed consent or comply with follow-up requirements
* Obstruction of the central veins (including the superior and inferior vena cava, bilateral iliac veins) such that the delivery system cannot be advanced to the heart via transvenous approach from either femoral vein or internal jugular vein
* Known intravenous drug abuse
Drug-Drug Interaction Study of Lorecivivint and Triamcinolone Acetonide in Healthy Volunteers

This study will be an open-label, parallel-arm study to determine if a prior intra-articular (IA) injection of lorecivivint (LOR) affects the safety, tolerability, and/or pharmacokinetics (PK) of a subsequent IA injection of the corticosteroid triamcinolone acetonide (TA) into the same knee, and to determine if a prior IA injection of TA affects the safety or tolerability of a subsequent IA injection of LOR into the same knee.


Eligibility Criteria:
Key Inclusion Criteria:

1. Males and females between 18 and 55 years of age, inclusive, in general good health
2. Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at Screening
3. Negative drug test for amphetamine, cocaine, methadone, opiates, phencyclidine (PCP), barbiturates, benzodiazepines, tricyclic antidepressants, and marijuana

Key Exclusion Criteria:

1. Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as 12 months with no menses without an alternative medical cause) or permanently surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) who have a positive or indeterminate pregnancy test result at the Screening Visit or Day -1
2. Women who are not post-menopausal or permanently surgically sterile who are sexually active, and who are not willing to use birth control during the study period
3. Men who are sexually active and of reproductive potential, who have partners who are capable of becoming pregnant, and who are not willing to use birth control during the study period
4. Any chronic medical condition that requires medication
5. Any history of IA injection, surgery (e.g., arthroscopy), infection, major orthopedic injury, or inflammatory rheumatic diseases (e.g., rheumatoid arthritis, gout, pseudogout) of either knee
6. Any contraindications for an IA injection in the right knee in the opinion of the Investigator
7. Previous treatment with lorecivivint (LOR)
8. Treatment with any glucocorticoids (oral, intravenous, intramuscular, IA, topical, or inhaled) within 12 weeks before Day 1
9. Consumption of grapefruit, grapefruit juice, Seville oranges, or vegetables from the mustard green family (e.g., kale, broccoli, watercress, collard greens, kohlrabi, brussels sprouts) within 10 days before Day 1
10. Known hypersensitivity to triamcinolone acetonide (TA)
11. Significant blood loss (\> 500 mL) or donation of blood within 30 days of screening
12. Regular use of nicotine-containing products, including, but not limited to, cigarettes, e-cigarettes, or nicotine gum or patches
13. Any condition, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation
14. Estimated glomerular filtration rate (eGFR) of \< 60 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease (MDRD) equation at the Screening Visit
Evaluation of Apelin-13 and Apelin-36 in Women With Recurrent Pregnancy Loss

Lower Apelin levels are associated with hypertensive disorders with pregnancy, yet no studies investigated its levels in recurrent pregnancy loss


Eligibility Criteria:
Inclusion Criteria:

* pregnant women in first trimester
* negative antiphospholipid markers
* normal karyotype

Exclusion Criteria:

* multiple pregnancy
* fetal malformations
* maternal diseases
* smoking or alcohol use
* history of or risk factors for preterm labor
Clinical Research on Retinal Neovascularization of Diabetic Retinopathy

Retinal neovascularization of diabetic retinopathy might be associated with genetic risk factors and environmental risk factors.


Eligibility Criteria:
Inclusion Criteria:

* T2DM was diagnosed according to the World Health Organization Expert Consultation Report 1999 and consisted of one of the following: fasting blood glucose (FBG) ≥7.0 mmol/L (≥126 mg/dL), blood glucose ≥11.1 mmol/L (≥200 mg/dL) 2 hours after an oral glucose tolerance test (OGTT); or a random blood glucose ≥11.1 mmol/L (≥200 mg/dL).
* DR was clinically graded in accordance with the International Clinical Diabetic Retinopathy guidelines based on fundus fluorescence angiography.
* All participants with PDR underwent a comprehensive dilated fundus examination to detect DR by indirect ophthalmoscopy and were diagnosed by fundus fluorescence angiography.

Exclusion Criteria:

* Patients were excluded if they had acute complications of diabetes mellitus, type 1 diabetes mellitus, other types of diabetes, serious cardiovascular, hepatic, nephritic or other complications, other serious primary diseases or mental illness.
A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis

This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Relapsing Multiple Sclerosis (RMS) according to the revised McDonald 2017 criteria (Thompson et al. 2018)
* Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
* Absence of relapses for 30 days prior to the screening visit
* For the dose escalation phase for participants pretreated with ocrelizumab (Group A):

treatment with IV ocrelizumab for at least 1 year prior to screening (i.e., at least two 600-mg doses of ocrelizumab separated by 24 weeks)

* For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab.
* For female perticipants without reproductive potential:

Women may be enrolled if post-menopausal unless the participant is receiving a hormonal therapy for her menopause or if surgically sterile (i.e., hysterectomy, complete bilateral oophorectomy).

Exclusion Criteria:

* MS disease duration of more than 15 years for participants with an Expanded Disability Status Scale (EDSS) score \<2.0 at screening.
* Known presence of other neurologic disorders that may mimic MS, including, but not limited to, the following:
* History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia of the spinal cord
* History or known presence of Central Nervous System (CNS) or spinal cord tumor (e.g., meningioma,glioma)
* History or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency)
* History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-lymphotropic virus 1, herpes zoster and myelopathy.
* History of genetically inherited progressive CNS degenerative disorder (e.g., hereditary paraparesis and mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke syndrome)
* Neuromyelitis optica
* History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjögren syndrome, Behçet disease, sarcoidosis).
* History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression