cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Safety, Pharmacokinetics and Immunogenicity of CR8020 in Japanese Healthy Participants

The purpose of the study is to assess the safety, pharmacokinetics (what the body does to the drug) and immunogenicity (ability of a particular substance to provoke an immune response in the human body) of CR8020 in japanese healthy participants

This study is a randomized (study medication is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), placebo-controlled (placebo comparator is compared with the study medication to evaluate safety profile of the study medication in clinical study), single-dose study in Japanese healthy adult male participants. The study will include screening phase (28 to 2 days prior to the study medication administration), treatment phase (Study medication will be administered on Day 1), and follow-up phase (up to 99 days). Twelve participants will be randomly assigned to CR8020 50 mg/kg or placebo groups in a 2:1 ratio and receive an assigned treatment on Day 1. Safety will be assessed by evaluating adverse events, clinical laboratory tests, 12-lead Electrocardiogram, vital signs, and physical examination. Total maximum duration of participation of an individual participant will be 127 days.

Eligibility Criteria:
Inclusion Criteria:

* Have signed an informed consent document
* Body mass index between 18 and 30 kg/m2, with body weight greater than or equal to 50 kg at screening
* Must agree to use an adequate contraception method (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm from the study drug administration until Day 99
* Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic at screening
* Non-smoker or participant who smokes no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before the study drug administration

Exclusion Criteria:

* History of or current clinically significant medical illness determined by the investigators including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, and coagulation disorders
* Clinically significant abnormal values for hematology, clinical chemistry or urinalysis
* Clinically significant abnormal physical examination, vital signs or 12-lead electrocardiogram
* A diagnosis of influenza infection or any constellation of clinical symptoms consistent with influenza infection within 14 days before the study drug administration is scheduled
* Participants with a fever of over 37.5°C on Day -1 or at predose
Study of Etanercept in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Adalimumab or Infliximab Plus Methotrexate

The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.

This study was prematurely terminated on June 25, 2014 due to significant and continuing delays in achieving the study B1801355 enrolment target. The decision to stop the study was not driven by any safety concerns.

Eligibility Criteria:
Inclusion Criteria:

1. Met the 1987 ACR Revised Criteria for RA
2. A history of inadequate response to infliximab or adalimumab in combination with methotrexate.
3. A stable dose of oral methotrexate for at least 6 weeks before the baseline visit.

Exclusion Criteria:

1. ACR functional class IV
2. Prior treatment with etanercept; both infliximab and adalimumab; or any immunosuppressive biologic agent other than infliximab or adalimumab.
3. Discontinuation of infliximab or adalimumab for a primary reason other than inadequate efficacy response.
Low-Dose Naltrexone in Combination With Standard Treatment in Women With Endometriosis

The purpose of this study is to determine if the addition of Low Dose Naltrexone to standard endometriosis treatments will improve patient reported endometriosis associated pain.

The central hypothesis of the research study is that low dose naltrexone (LDN), in combination with hormonal suppression of endometriosis (standard of care), will lead to significant improvement of endometriosis-related pain.

The proposal seeks to:

1. determine if the addition of LDN to standard endometriosis treatments will improve patient- reported endometriosis associated pain using daily Visual Analogue Scale (VAS) scores and
2. measure the impact of treatment on quality of life as measured by validated questionnaires including the Endometriosis Health Profile-30 (EHP30) and the Patient's Global Impression of Change (PGIC).

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal female ages 18 to 45 years old on the day of signing informed consent.
* Must agree to use only study-specific analgesic medications during the study and is not known to be intolerant to them.
* Diagnosed with endometriosis and has had, within the last 10 years prior to signing the informed consent, surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis.
* Is not expected to undergo gynecological surgery or other surgical procedures for treatment of endometriosis during the study period.
* Agrees to use contraception if not surgically sterile during the entire study.
* Patients using oral contraceptives, LARCs and/or GnRH agonists/antagonists for contraception and/or management of endometriosis, with a stable regimen, will be able to continue in the study, however, women using oral contraceptives and GnRH agonist/antagonists will be switched to Norethindrone acetate during the 1-2 week run-in period as prescribed by principle investigator.

Exclusion Criteria:

* Women that are pregnant, breastfeeding or trying to conceive.
* Patients with chronic daily narcotic use and any chronic pain or frequently reoccurring pain condition, other than endometriosis, that is treated with opioids or requires analgesics for more than 7 days per month.
* Patients with abnormal liver function tests (greater than 3x normal limit) in the past year or history of liver disease. Routine screening of liver function is not required.
* Non-English speaking or inability to read and understand English secondary, in part, to the need to read and report daily results in English.
* Undiagnosed vaginal bleeding
* Patients with history of opioid, illicit drug or alcohol abuse
* Patients currently taking thioridazine
* Patients with a history of suicidality
* Patients with current or history of unstable depression or other psychiatric disorder who, by PI judgement, are unstable or not well controlled
* Known, suspected or history of cancer of the breast
* Active deep vein thrombosis, pulmonary embolism or history of these conditions
* Active or recent arterial thromboembolic disease (e.g., stroke, myocardial infarction)
Glioma Developmental and HyperActive Ras Tumor (DHART) Board

This study will collect medical records, scan results, and complete surveys to create a registry about people with a neurofibromatosis type 1-associated brain tumor (NF1-associated glioma). A registry is a collection of health information about individuals, and it is usually focused on a specific diagnosis or condition.

This registry study will help the researchers learn more about the diagnosis, treatment, and quality of life of people with NF1-associated glioma. The researchers want to understand what happens as a result of different treatments for NF1-associated glioma and how these treatments and the disease itself affect people's lives over a period of time. Information collected during this study could affect how doctors diagnose, test, and treat NF1-associated glioma, and the study could help future patients with this type of cancer.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis that meets NIH criteria for NF1 disease by either 1) documented clinical record establishing NF1 or 2) self-reported with supported documentation upon medical record collection.
* Willing to have historical and future NF1 related health records sent to registry for review.
* Radiologic or pathologically confirmed glioma.
* Individuals ≥18 years of age on the date of informed consent.

Exclusion Criteria:

* Unwillingness to sign informed consent.
* No proficiency in English or Spanish as determined by the Investigator.
Cardiac Speckle Tracking Myocardial Strain Balance

The investigators intend to evaluate the function of left heart and right heart and the motion balance between four chambers of the heart by speckle tracking technique during the follow-up of patients with pulmonary hypertension, and explore the relationship between the balance and prognosis of patients.

Pulmonary hypertension is a fatal disease with progressive progressive vascular resistance that leads to the loss of right heart function. Right heart failure is the cause of death in most patients with end-stage pulmonary hypertension, and right heart function is also an important factor in determining the prognosis of patients.

Echocardiography speckle tracking technology is a noninvasive technique for evaluating global and local cardiac function by tracking myocardial ultrasonic spots through computer image analysis technology and quantifying myocardial deformation.

The investigators intend to evaluate the function of left heart and right heart and the motion balance between four chambers of the heart by speckle tracking technique during the follow-up of patients with pulmonary hypertension, and explore the relationship between the balance and prognosis of patients.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed with pulmonary hypertension by right cardiac catheterization The patient is between 18-80 years of age The date of diagnosis was from 2007 to 2017

Exclusion Criteria:

Cardiomyopathy Severe complications Pregnancy Atrial fibrillation, or other irregular heart rhythm Poor ultrasonic image quality
Ultrasound-guided Quadratus Lumborum Block for Postoperative Pain Relief After Cesarean Delivery

The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics close to the anterior border of the quadratus lumborum muscle. In our randomized, controlled, double-blinded study ultrasound-guided QL-blocks in 20 female patients after cesarean delivery will be compared with a placebo control group of 20 patients to investigate analgesic consumption, pain level, opioid related side effects and mobilization.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cesarean delivery
* American Society of Anesthesiologists classification (ASA) \< 3
* adequate communication skills
* Body mass index \< 32

Exclusion Criteria:

* ASA \> 2
* chronic pain
* neurological illness/ neuropathy
* contraindication against local anesthetics
Treatment of Acne Scarring With a Novel Procedure Combination

The primary objective of this study is to look at the efficacy of subdermal manipulation and filler injection in the improvement of acne scar appearance.

The primary objective of this study is to determine whether the use of subcision in conjunction with calcium hydroxylapatite injections will improve the appearance of rolling acne scars better than subcision alone.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Have two acne scar areas
* The subjects are in good health
* The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.

Exclusion Criteria:

* Under 18 years of age
* Pregnancy or Lactation
* Subjects who are unable to understand the protocol or to give informed consent
* Subjects with mental illness
Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma

The purpose of the present study is to find out if MRI techniques examining (1) the motion of water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition of the prostate (MR spectroscopy), can be used to detect prostate cancer early and non-invasively. Localization of the cancer within the prostate would be of particular importance in focal cryoablation of prostate carcinoma which we hope to improve as a result of this project.

Additional aim of the study is to correlate expression of genes believed to pay a role in prostate cancer with MRI findings.

Radical prostatectomy patients will undergo an MRI prior to their scheduled surgery. Ex vivo imaging will be done on prostates once removed. Results from the final pathology with be compared with results of imaging to determine the accuracy of the image analysis in cancer localization and staging.

Brachytherapy patients will undergo an MRI prior to their scheduled procedure. Two areas of suspected cancer and two areas without suspected cancer will be prospectively identified based on the MRI imaging. At the time of brachytherapy, transrectal needle biopsies will be obtained from the previously identified areas. The needle cores will be reviewed by study pathologist to determine the accuracy of the image analysis in cancer localization and staging.

Eligibility Criteria:
Inclusion Criteria:

* patients who have been diagnosed with prostate cancer and are scheduled for radical prostatectomy or for brachytherapy
* patients who have not received any preoperative treatment for their diagnosis of prostate cancer

Exclusion Criteria:

* patients with implants that are electronically, magnetically, or mechanically active
* patients with intracranial aneurysm clips
* patients who have undergone cosmetic eyelid surgery
* patients with history of pheochromocytoma, insulinoma and acute glaucoma
* patients with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2
A Multicentric Validation Study on the Accuracy of Artificial Intelligence Assisted System in Clinical Application of Digestive Endoscopy

This is an artificial intelligence-based optical artificial intelligence assisted system that can assist endoscopists in improving the quality of endoscopy.

Endoscopic diagnosis and treatment play an important role in the discovery and treatment of gastrointestinal diseases.With the rapid increase in the number of endoscopies, the workload of endoscopists increases further.The high workload reduces the quality of endoscopy, leading to incomplete coverage and incomplete detection of lesions.With the rapid increase in the number of endoscopies, the workload of endoscopists increases further.The high workload reduces the quality of endoscopy, leading to incomplete coverage and incomplete detection of lesions.Therefore, carrying out deep learning and other artificial intelligence methods has good academic research and practical value for improving the quality of endoscopic diagnosis and treatment.The research and development, testing and functional evaluation of artificial intelligence devices need to use a large number of endoscopic images, and at the same time, the effectiveness and safety of artificial intelligence devices need to be verified in different hospitals and environments.Based on this, our research group intends to collect endoscopic image data from different hospitals for training and validation of the model.

Eligibility Criteria:
Inclusion Criteria:

1. male or female aged 18 or above;
2. endoscopy and related examinations should be performed to further clarify the characteristics of digestive tract diseases;
3. be able to read, understand and sign the informed consent;
4. the researcher believes that the subject can understand the process of the clinical study, is willing and able to complete all the study procedures and follow-up visits, and cooperate with the study procedures;

Exclusion Criteria:

1. have participated in other clinical trials, signed the informed consent and have been in the follow-up period of other clinical trials;
2. drug or alcohol abuse or psychological disorder in the last 5 years;
3. pregnant or nursing women;
4. subjects with previous history of gastrointestinal surgery;
5. the researcher considers that the subject is not suitable for endoscopy and related examination;
6. high-risk diseases or other special conditions that the investigator considers inappropriate for the subject to participate in the clinical trial.
Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure

The purpose of this study is to evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.

To evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.We star with the dose M2ES 15mg,then escalate to 30mg 45mg 60mg,to find the recommended dose in clinic practise.

Eligibility Criteria:
Inclusion Criteria:

1. histologically or cytologically confirmed pancreatic adenocarcinoma that was not amenable to potentially curative surgery.
2. All patients must have developed progressive disease (PD) while receiving or within 6 months after discontinuing palliative gemcitabine-based chemotherapy
3. Prior radiation therapy was allowed provided that the only sites of measurable disease were not located within the radiation port.
4. 18 years of age or older
5. Karnofsky performance status (KPS) of 60-100 points
6. measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
7. Adequate hematologic, renal, and hepatic function was required as deWned by the following: WBC ≥3.5×109/L, absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥100 × 109/L, hemoglobin≥9g/dL, total bilirubin ≤2.5 upper limit of normal \[ULN\],AST≤2.5 ULN, or≤5 ULN if there was evidence of liver metastases;alkaline phosphatase≤ 2.5 ULN, or≤ 5 ULN if there was evidence of liver Metastases creatinine clearance≤50 mL/min,
8. life expectancy of at least 12 weeks

Exclusion Criteria:

1. patients had clinically apparent CNS metastases or carcinomatous meningitis
2. another active malignancy, or any history of other malignancy within the past 5 years except for nonmelanoma skin cancer and carcinoma in situ of the cervix
3. more than 3 weeks intervals between the last administration of the prior chemotherapy regimen and study entry
4. more than 4 weeks intervals between the last administration of the targeted therapy regimen and study entry
5. major surgery within the prior 6 weeks;
6. Pregnant or lactating women
7. tumor involvement of major blood vessels
8. uncontrolled intercurrent illness
9. A history of myocardial infarction or stroke within the last 6 months, uncontrolled hypertension, unstable angina
10. clinically significant cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication, or myocardial infarction)
11. urine protein ≥ 500 mg in 24 hours;
12. evidence of bleeding diathesis or coagulopathy
13. Patients on therapeutic doses of low-molecular weight heparin
14. Patients who received thrombolytic agents within the previous month or who required full-dose anticoagulation.
Diagnostic Accuracy of Using Point-of-care Ultrasonography for Confirming Nasogastric Tube Placement

A prospective observational diagnostic study will be conducted to assess the sensitivity and specificity of ultrasound in verifying the correct nasogastric tube placement, using X-ray as the reference standard.

This study is a prospective observational diagnostic investigation aimed at evaluating the accuracy of ultrasound in confirming nasogastric tube (NGT) placement. Participants aged 18 years or older requiring NGT insertion will be recruited via convenience sampling from community nursing centres across five clusters and medical and geriatric wards in four acute or convalescent hospitals. Nurses performing index tests will complete standardized POCUS training (8-hour theory and practical sessions, written exams, 3-month bedside practicum with ≥20 positive scans) prior to competency assessment. Direct visualisation of an NGT in both the oesophagus and stomach will be interpreted as correct stomach placement. When the acoustic shadow of an NGT was not seen in the stomach, 50cc of air was injected through the NGT, and it was considered well-placed if the ultrasonography showed dynamic fogging. Correct gastric placement is assumed if the acoustic shadow of an NGT is visible in the oesophagus and stomach, even if fogging is not detectable. The reference standard will be post-index test X-ray confirmation. Diagnostic performance metrics, including sensitivity, specificity, positive and negative predictive values, and likelihood ratios, will be calculated to assess the efficacy of ultrasound. Variability in diagnostic accuracy across participant characteristics will be analyzed. Additionally, the study will compare the time intervals between ultrasound and X-ray, delays in feeding initiation post-placement, and associated costs, including emergency department admissions, unplanned hospitalizations, and ambulance transportation.

The findings will provide critical evidence on the diagnostic utility of ultrasound for NGT placement verification, informing potential revisions to clinical practice guidelines and supporting stakeholder decisions on integrating ultrasound as a reference test.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older;
* Living in the community or admitted to a medical and geriatric ward;
* Requiring the use of an NGT during the recruitment period for assessment, monitoring, nutritional assistance, drainage, and/or medication administration;
* Aspirated fluids with a pH value of more than 5.5 after insertion or with insufficient fluids for pH testing after insertion;

Exclusion Criteria:

* Uncooperative patients;
* Had head and neck injury
* Have had a gastrectomy or by-pass surgery;
* History of abdominal trauma or receiving emergency life support intervention at time of recruitment.
A Study to Evaluate the Efficacy and Tolerability of Zoledronic Acid in Patients With Metastatic Prostate Cancer Who Can be Treated With a Group of Medications Known as Bisphosphonates

The purpose of this study is to assess the efficacy and tolerability of zoledronic acid in preventing skeletal-related events in patients with prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained
* Age \> 18 years
* Histologically confirmed diagnosis of carcinoma of the prostate
* Current (or previous) objective evidence of metastatic disease to the bone
* Currently receiving 1st line hormonal therapy with LHRH agonists or other hormonal treatments
* ECOG performance status of 0, 1, or 2

Exclusion Criteria:

* Patients with abnormal renal function as evidenced by either a serum creatinine determination 1.5 x or greater above the upper limit of normal or by a calculated creatinine clearance of 60 ml/minute or less
* Corrected (adjusted for serum albumin) serum calcium concentration \< 8.0 mg/dl (2.00 mmol/L)
* WBC\<3.0x1'000'000'000, ANC \< 1500/mm3, Hgb\<8.0 g/dL, platelets \< 75 x 1'000'000'000/L.
* Liver function tests \>2.5 ULN, serum creatinine \>1.5 ULN.
* Patients with another nonmalignant disease which would confound the evaluation of primary endpoints or prevent the patient complying with the protocol.
* Known hypersensitivity to zoledronic acid or other bisphosphonates
* Subjects who, in the opinion of the investigator, are unlikely to cooperate fully during the study

Other protocol-defined inclusion / exclusion criteria apply.