cyrilzakka/clinical-trials huggingface dataset:
Safety Study of 89Zr-NY001 PET Imaging in Patients

This is a single arm study to evaluate the safety and biodistribution of 89Zr-labeled NY001 (89Zr-NY001) PET imaging in patients with fibronectin ED-B domain positive solid tumors.

After being fully informed about the study and potential risks, all patients giving written informed consent will be evaluated to determine eligibility for study entry. Patients will receive an injection of 89Zr-NY001 and will undergo PET/CT scanning to determine uptake of 89Zr-NY001 in tumor lesions and the whole body.

Eligibility Criteria:
Inclusion Criteria:

1. Patients voluntarily signed informed consent;
2. Aged \>18, male or female;
3. Patients diagnosed with solid tumors confirmed by histopathology or cytology test;
4. At least two measurable solid lesions has been examined by 18F-FDG PET/CT (RECIST1.1 standard);
5. Patients with biopsy-proven fibronectin ED-B positive;
6. ECOG score ≤ 0\~3; Life expectancy of at least 3 months;
7. Women of childbearing age are required to receive serum pregnancy tests, and only those who have a negative pregnancy test for eligible subjects;
8. ALT, AST shall not exceed 3 times of the normal upper limit; Bun, Cr not exceed 1.5 times of the normal upper limit;
9. Other routine examinations are within the normal range or considered acceptable by the researchers.

Exclusion Criteria:

1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
3. Patients with allergies or allergies to any component of the imaging agent or antibody;
4. Patients who cannot perform PET/CT imaging scan;
5. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
6. Patients with autoimmune diseases, including rheumatoid arthritis;
7. Inadequate control of arrhythmias, including atrial fibrillation;
8. Uncontrolled hypertension;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.
Combi-elastography Assessment of HCC Recurrence After Thermal Ablation Multi-center Study

Combined F index, A index,ATT index and spleen stiffness to predict tumor recurrence in different liver settings after thermal ablation of HCC.

Thermal ablation is one of the established method for HCC treatment. Postoperative recurrence of HCC is one of the major factors leading to poor prognosis of HCC patients. Most studies have shown that the risk factors of recurrence include tumor size, tumor number and intrahepatic spread, etc.

Besides, the carcinogenic effects of inflammatory activity and fibrosis in liver background caused by chronic hepatitis also be related to the recurrence. In the study, combi-elastography imaging technology , not only the F index which is related to liver fibrosis stage can be obtained, but also the A index which is related to inflammation activity can be measured, this may provide a more valuable method for tumor recurrence of early prediction.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 80 years of age, and gender not limited;Chronic hepatitis B patients;The lesions of liver have the histopathological diagnosis of HCC and within MiLan criteria;All lesions were performed thermal ablation surgery;Sign the informed consent.

Exclusion Criteria:

* Lesions that unrealized complete inactivation evaluation by the enhanced imaging;Merging other systems' serious illness that can't cooperate with elastic imaging checking(such as heart failure, renal failure, such as mental illness);After liver transplantation patients;Patients with pregnancy.
Effect of Archwire Gauge on the Rate of Canine Retraction

trial will be done to evaluate the effect of archwire gauge on the rate of canine retraction, canine tip and torque, root resorption and loss of anchorage in maxillary dental protrusion cases requiring first premolars extraction.

Three working archwires of different gauges will be used during canine retraction; st.st 0.019×0.025" as a comparator, st.st 0.016×0.022" and st.st 0.017×0.025" wires as interventions. after levelling and alignment till reaching the working archwire, it will be left in place for a month then maxillary first premolars will be extracted and base line records will be taken(digital models, digital periapical radiographs and panorama). digital models will be taken monthly to measure rate of canine retraction for 6 months. after 6 month evaluation of anchorage loss, change in canine tip and torque will be done on last obtained digital model , panorama will be taken to evaluate the change in canine tip and digital periapical radiograph will be taken and compared with the preretraction radiograph to evaluate amount of root resorption.

Eligibility Criteria:
Inclusion Criteria:

* Adult females (age range 18-28 years old).
* Maxillary dental protrusion indicating first premolars extraction.
* Full permanent dentition (not necessitating third molars).

Exclusion Criteria:

* Patients having systemic diseases or on medications that would affect tooth movement.
* Active periodontal disease or obvious bone resorption in maxillary arch.
* Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting ... etc.).
* Previous orthodontic treatment.
* Missing teeth.
The Effect of Probiotics on Gut Microbiotain After Helicobacter Pylori Eradication

The purpose of this study is to evaluate the effect of probiotics during vonoprazan-amoxicillin dual therapy on the gut microbiota in Helicobacter pylori eradication and to investigate whether the eradication rate of H.pylori will be improved when adding probiotics

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirement will be included in this simultaneous blind test. A total of 100 patients with HP infection were enrolled in this study. All patients were randomly divided into two groups according to the ratio of 1:1. Group A was given vonoprazan 20mg bid, amoxicillin 1000mg tid, Probiotics 3tabltes tid for 14 consecutive days; Group B was given vonoprazan 20mg bid and amoxicillin 1000mg tid for 14 days. On the 14th days of treatment, the researchers will follow up the patients' adverse reactions and medication compliance. The feces of the subjects were collected one day before the treatment, and on the 14th and 42th days after the treatment; After 4 weeks of drug withdrawal, all subjects will be reexamined with 13C-UBT.

Eligibility Criteria:
Inclusion Criteria:

1. Ages between 18 and 65 years; Sexes eligible for study: both;
2. patients who are diagnosed with Helicobacter pylori;
3. treatment-naive patients or patients who failed to eradicate Helicobacter pylori in the past but haven't undergone eradication therapy in the past six months;
4. voluntary to be involved in the study and written informed consent was obtained from all patients

Exclusion Criteria:

1. allergic reactions to the study drugs;
2. patients with peptic ulcer;
3. patients who underwent eradication therapy for Helicobacter pylori during the last six months;
4. patients who took antibiotics,bismuth agents,probiotics within four weeks prior to treatment and those who took H2 receptor antagonists,proton pump inhibitors(PPIs) or potassium competitive acid blockers within two weeks prior to treatment;
5. patients who are taking glucocorticoids, non-steroidal anti-inflammatory drugs or anticoagulants;
6. patients who have history of esophageal or gastric surgery;
7. pregnant or lactating women;
8. patients who have severe concurrent diseases such as hepatic,cardiovascular,respiratory,renal disorders or malignancies;
9. Alcohol abusers
Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)

The overall objective of this proposed project is to prospectively evaluate the epigenetic and developmental effects of paternal cannabis and other drug use in offspring.

This project involves enrollment of 40 healthy mother-father dyads that are between the ages of 18 and 40 years. Urine samples for qualitative drug and cotinine testing will be collected from mother-father dyads, as well as quantitative THC (tetrahydrocannabinol) and THCCOOH (11-nor-9-carboxy-THC) assay. A semen sample will be collected from biological fathers. Relevant birth outcome data including both infant and maternal measures will be extracted from the electronic health record (EHR). Infant developmental assessments will be completed at approximately 6 months of age.

Eligibility Criteria:
Inclusion Criteria:

1. Both mother and father are between 18 and 40 years of age
2. Free from significant medical conditions, as determined by medical history and examination from attending Obstetrician or health care provider.
3. Father is able to be contacted and consents to provide urine and sperm samples
4. Both mother and father consent to participation and for the prospective enrollment of their child after birth
5. Plan on delivering their baby at one of the two main Duke-affiliated hospitals (Duke University Medical Center and Duke Regional Hospital)

Exclusion Criteria:

1. Mother or Father currently prescribed any psychoactive medication;
2. Mother or Father unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the PI.
A Study of Paclitaxel With or Without Ramucirumab (LY3009806) in Participants With Gastric or Gastroesophageal Cancer

The purpose of this study is to evaluate the efficacy of the study drug known as ramucirumab in participants with gastric and gastroesophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Have an Eastern Cooperative Oncology Group Performance Status (ECOGPS) of 0 or 1 at study entry.
* Have a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction (GEJ) adenocarcinoma.
* Have metastatic disease or locally advanced, unresectable disease.
* Have at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1.
* Have experienced documented objective radiographic or symptomatic disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum/fluoropyrimidine doublet for unresectable or metastatic disease.
* Have adequate organ function.
* Have urinary protein ≤1+ on dipstick or routine urinalysis.

Exclusion Criteria:

* Have undergone major surgery within 28 days prior to randomization.
* Have received any first-line chemotherapy other than platinum and fluoropyrimidine with or without anthracycline for advanced gastric or GEJ adenocarcinoma.
* Have received any previous systemic therapy (including investigational agents) targeting vascular endothelial growth factor (VEGF) or the VEGF receptor signaling pathways.
* Have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to randomization.
* Have significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry.
* Have a history of GI perforation and/or fistulae within 6 months prior to randomization.
* Have experienced any arterial thromboembolic event within 6 months prior to randomization.
* Have uncontrolled arterial hypertension (systolic blood pressure ≥160 millimeters of mercury \[mmHg\] or diastolic blood pressure ≥100 mmHg) despite standard medical management.
* Have a serious or nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to randomization.
* Have a serious illness or medical condition(s).
The Effect of the Hyperinsulinemic Normoglycemic Clamp on Myocardial Function and Utilization of Glucose

The overall research plan is to test the hypothesis that intraoperative treatment of hyperinsulinemic normoglycemic clamp (HNC) in cardiac surgical patients improves myocardial function and short-term outcomes compared with standard glucose management.

Specific Aim #1:To determine whether intraoperative use of HNC affords cardioprotective benefits measured by improved echocardiographic measures of myocardial function, serum markers of cardiomyocyte injury, and hemodynamic indices measured immediately (at end of surgery) and during the short-term (initial hospitalization).

Eligibility Criteria:
Inclusion Criteria:

* Age 40 - 84 years old, Aortic stenosis, Scheduled for Aortic valve replacement.

Exclusion Criteria:

* Poor quality echocardiographic images unsuitable for analysis
* Off -pump surgical procedure
* Anticipated deep hypothermic circulatory arrest
* Any contraindications to transesophageal echocardiogram (TEE) or other proposed intervention
* Unable to give written informed consent (non-English speaking, vulnerable patients, etc.)
Intralesional Vitamin D in Alopecia Areata

To evaluate the efficacy and safety of intralesional injection of vitamin D3 versus intralesional injection of corticosteroids in treatment of alopecia areata.

this will be carried out on 40 patients who attend hair outpatient clinic, department of dermatology, Faculty of medicine, Alexandria University, Egypt.

The patients will be randomly assigned into two groups (A and B), each group contains 20 patients. Patients will be blindly subjected to intralesional injection of triamcinolone acetonide (5mg/ml) using sterile saline for dilution every 4 weeks for 3 sessions (11,12) or intralesional injection of vitamin D (an aqueous preparation of cholecalciferol (Devarol® ampoule 200,000 IU/2 mL, Memphis, Egypt) (2.5 mg/mL) every 4 weeks for 3 sessions. The maximum total amount of vitamin D3 injected into a patient in 1 session will be 5 mg Injection will be preceded by topical anaesthesia under occlusion for 30 minutes.


Eligibility Criteria:
Inclusion Criteria:

Site: scalp. Extent: localized alopecia areata (less than 50% scalp involvement).

Exclusion Criteria:

1. Other skin diseases affecting the scalp
2. Pregnant or lactating women.
3. Bleeding or coagulation disorders
4. Immunocompromised patients.
5. Known hypersensitivity to vitamin D3.
6. Patients who received systemic or topical treatment for alopecia areata in the last month.
7. Patients taking vitamin D supplements in the last 6 months.
8. Patients treated with topical vitamin D analogues.
9. Patients with diseases known to alter vitamin D level as autoimmune diseases, liver or renal diseases.
10. Obesity (defined as body mass index ≥ 25).
A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy

To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Women must not be at risk to become pregnant during study participation
* Diagnosis of Rheumatoid Arthritis (RA)
* Current, regular use of Methotrexate, at a stable dose
* Other criteria to be reviewed by study doctor

Exclusion Criteria:

* Use of excluded medications(reviewed by study doctor)
* Have not failed biologic tumor necrosis factor-alpha (TNF-α) inhibitor therapy
* Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
* Evidence of tuberculosis
* Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
* Other criteria to be reviewed by study doctor
A Clinical Study on the Effect of Hypoglycemic Drugs on the Prognosis of Spinal Surgery in Diabetic Patients

Diabetes mellitus is a group of metabolic diseases caused by multiple etiologies and characterized by chronic hyperglycemia. It seriously harms human health and has become a global public health challenge. Diabetes mellitus is present in 5% to 25% of patients undergoing spine surgery, and the prevalence has been increasing over the past decade. It is worth noting that spinal surgery for patients with diabetes has significant risks, mainly manifested in the significant increase of postoperative complications such as wound infection, delayed healing and wound hematoma, which seriously affect the long-term prognosis of patients' quality of life, spinal function and stability of internal fixation. Research shows that hypoglycemic drugs can not only control blood glucose level, but also affect the stability of nerve, bone and internal fixation, which is expected to improve the prognosis of spinal surgery in patients with diabetes. Metformin and sitagliptin are widely used hypoglycemic drugs. Studies have shown that metformin can increase bone mineral density in patients and have a protective effect on bones. Sitagliptin induces macrophage polarization of the M2 phenotype and reduces the impaired behavior of osteoblasts on titanium (TI) implants in a dose-dependent manner, thereby enhancing the bone regeneration required for successful orthopedic and dental implants in diabetic patients. However, the effects of these two drugs on the long-term prognosis of diabetic patients after spinal surgery, such as quality of life, spinal function and stability of internal fixation, have not been reported.

This investigation is a prospectie cohort study. The purpose of this study is to determine whether metformin and sitagliptin are associated with patient-reported outcomes and internal fixation stability at one year following elective spine surgery. Providers may use this information to help patients who need elective spinal surgery choose hypoglycemic drugs and to counsel patients with diabetes on expectations following spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective spinal surgery;
* Clinical diagnosis of diabetes (using the diagnostic criteria proposed by the WHO Expert Committee on Diabetes in 1999);
* Use metformin or sitagliptin;
* The age ranges from 18 to 90;
* Sign informed consent.

Exclusion Criteria:

* Acute traumatic injury;
* Patients with cerebral hemorrhage, cerebral infarction, Parkinson's disease, spinal cord transverse syndrome, spinal cord hemiere syndrome, Guillan-Barre syndrome and other neurological diseases affecting patients' somatosensory and motor;
* Combined with rheumatoid arthritis, ankylosing spondylitis and other rheumatoid arthritis;
* Patients with long-term use of glucocorticoids;
* complicated with malignant tumor;
* Pregnant women;
* Suffering from schizophrenia, bipolar disorder, hysteria and other mental diseases;
* The use of two or more than two mechanisms of hypoglycemic drugs;
* Do not sign informed consent.
Evaluating the Effectiveness of Colon Preparation for Endoscopy Using Specialized Clinical Nutrition

This study is an open, prospective, comparative diagnostic studies aimed at improving the colonoscopy results, by optimizing the way of preparation for endoscopy

Objective: to improve the quality of bowel preparation for endoscopy.

Research objectives:

1. Compare the three methods of colon preparation for endoscopy
2. To develop a rational strategy of preparing patients for endoscopy on the basis of the data obtained.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years with the recommendation to conduct a diagnostic colonoscopy
2. Absence of contraindications to the use of specialized clinical nutrition products

Exclusion Criteria:

1. Conditions which are contraindicated for colonoscopy:

   * The acute phase of cerebrovascular accident
   * Acute myocardial infarction
   * severe cardiovascular, pulmonary insufficiency and mixed
   * Violations of the cardiac rhythm (paroxysmal bradyarrhythmia, atrial fibrillation with atrial fibrillation or paroxysmal atrial fibrillation, severe transverse heart block)
   * Severe clinical forms (fulminant) inflammatory diseases of the colon (ulcerative colitis, Crohn's disease, ischemic colitis, radiation colitis, diverticulitis)
   * Aortic aneurysm or heart
   * Acute inflammatory infiltrates abdominal cavity (including diverticulitis)
   * Suspicion of abscess of the abdominal cavity
   * Peritonitis
   * Hepatosplenomegaly
   * Tense ascites
   * hydrothorax, hydropericardium
   * Severe blood coagulation
   * Hemorrhagic vasculitis
2. Pregnancy
3. The patient's refusal to participate in the study
4. Intolerance of specialized clinical nutrition products
Safety and Efficacy of YHD001 in Asthma

The main objective is to evaluate the safety/tolerability and efficacy of YHD001 compared to singulair or placebo in patients (n=96) with partially controlled asthma.

The study will conduct with 4 comparative groups orally treated with YHD001 dose level 1(t.i.d.), YHD001 dose level 2(t.i.d.), singulair 10mg(q.d.) or Placebo for 8 weeks.

Singulair: Montelukast sodium (leukotriene modulator)

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent
* Acceptable medical history, physical exam,laboratory tests and EKG, during screening
* Nonsmoking (for longer than 1 year) patients with asthma
* Reversible airways obstruction (an increase in FEV1 absolute value of 12% or greater) 20 to 30 minutes after inhalation of b-agonist
* FEV1 between 50% and 85% of the predicted value (withholding short-acting, inhaled b2-adrenergic agonist for 6 hours)

Exclusion Criteria:

* History of any clinically significant disease
* History of drug/chemical/alcohol abuse
* Active upper respiratory tract infection within 3 weeks, emergency room treatment for asthma within 1 month, or hospitalization for asthma within 3 months of the prestudy visit