cyrilzakka/clinical-trials huggingface dataset:
68Ga-PSMA PET/CT in Detecting Prostate Cancer Recurrence in Patients With Elevated PSA After Initial Treatment

The purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (PET) scan. PET/CT is used to describe information regarding the function, as well as location and size of a tumor.

PRIMARY OBJECTIVES:

I. To evaluate 68Ga-PSMA-11 PET/CT for detection of recurrent prostate cancer after initial therapy in patients with elevated PSA. PSMA refers to prostate-specific membrane antigen.

Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 68Ga-PSMA-11 and undergo a PET/CT. Participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. Clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological proven prostate adenocarcinoma
* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)

  * Post radical prostatectomy (RP) - American Urology Association (AUA) recommendation

    * PSA greater than 0.2 ng/mL measured 6 to 13 weeks after RP
    * Confirmatory persistent PSA greater than 0.2 ng/mL (total of two PSA measurements greater than 0.2 ng/mL)
  * Post-radiation therapy -American Society for Radiation Oncology (ASTRO)-Phoenix consensus definition

    * A rise of PSA measurement of 2 or more ng/mL over the nadir
* Karnofsky performance status of ≥ 50 (or Eastern Cooperative Oncology Group \[ECOG\] / World Health Organization \[WHO\] equivalent)
* Able to provide written consent

Exclusion Criteria:

* Investigational therapy for prostate cancer.
* Unable to lie flat, still or tolerate a positron emission tomograpy (PET) scan.
* Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
Observational Cohort Study of TachoSil (TC-018-IN)

The purpose of this study is to collect information, after exposure to TachoSil ®, of all thromboembolic events, immunological events and drug interactions leading to thromboembolic events or major bleeding. In addition, pharmacoeconomic data will be collected.


Eligibility Criteria:
Inclusion Criteria:

* All subjects, treated with TachoSil ® by the participating physicians, will be registered with a set of basic data from their already existing data (i.e. no additional diagnostic procedures will be performed).
* Subjects who will provide their written informed consent to use existing data, allow direct access to data and data processing.
Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)

This analytical descriptive study aims to describe the fertility and sexuality male adult subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual self-esteem and a semen analysis will be realized at first consultation, semen analysis results wil be explained at second consultation. It is assumed that fertility and sexuality exstrophic men are impaired.


Eligibility Criteria:
Inclusion Criteria:

* Patients followed the Hospices Civils de Lyon
* Consultant spontaneously in adult or pediatric Urology, or neuroperineal rehabilitation and sexology
* Aged over 18 years
* Born with classic bladder exstrophy or epispadias.

Exclusion Criteria:

* Refusal of participation
* Refusal to sign consent
* minor Patients or protected major, under guardianship
* Patients unable to understand the course of the study
* cloacal exstrophy
Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation

The purpose of the proposed study is to examine if a repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral therapy with mindfulness classes.


Eligibility Criteria:
Inclusion Criteria:

* all patients who have agreed to participate in virtual mental health treatment at health care sites throughout Manitoba. Eligible participants will be those enrolled in a range of mental health programs, including CBT, DBT, virtual hospital wards, and group-based treatment (e.g., CBTm, Managing Difficult Emotions, etc). The target population will also include providers and decision makers offering virtual mental health programs. Individuals must meet the following criteria to be eligible to participate in the study: 1) must be a patient/client enrolled in a virtual mental health program OR a provider/decision maker offering a virtual mental health program, and 2) located within Manitoba

Exclusion Criteria:

* contraindication for MRI (e.g., metallic implants and claustrophobia)
Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention

This study is designed to evaluate the efficacy and safety of Recombinant Human Brain Natriuretic Peptide (rhBNP) in improving ventricular remodeling and cardiac function after acute anterior myocardial infarction undergoing percutaneous coronary intervention. 100 patients with acute anterior myocardial infarction after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to rhBNP group(n=50) and control group(n=50) with follow-up of 24 weeks. Both groups are treated with standard therapy of AAMI, with the rhBNP group intravenous dripping rhBNP after pPCI for 3 days and the control group treated with placebo at the same time. The primary endpoint is the change in N terminal pro-B-type natriuretic peptide（NT-proBNP ）and cardiac troponin T(cTnT) level.The secondary endpoint is the change in 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI), arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).


Eligibility Criteria:
Inclusion Criteria:

1. The first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ).
2. Age 18-75 years old, gender unlimited
3. Patients with acute anterior myocardial infarction undergoing emergency PCI within the effective time window
4. Successful reflow after interventional therapy ( TIMI = 3 ).
5. To understand and sign the informed consent.

Exclusion Criteria：

1. Patients with a history of coronary artery bypass grafting
2. Patients with cardiogenic shock
3. Patients with systolic blood pressure ( SBP ) ≤ 90 mmHg after treatment with vasopressors
4. Patients with mechanical complications ( ventricular septal perforation, mitral chordae rupture )
5. Patients with suspected aortic dissection
6. Patients with severe liver and kidney dysfunction
7. Allergic or intolerant to rhBNP.
8. Patients with chronic renal insufficiency requiring long-term dialysis
9. Patients using diuretics during the screening period
10. Pregnant / lactating women
11. Heart diseases that are not suitable for vasodilators, such as severe valve stenosis, restrictive cardiomyopathy, restrictive pericarditis, etc
Bioequivalence Study betweenYHP2407 and YHR2502 in Healthy Subjects

A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2407 and YHR2502 in healthy volunteers

40 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "comparator" and "YHP2407" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2407" and "comparator" by crossover design on period 1, 2.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18-30 kg/m2
* Those without clinically significant congenital or chronic diseases

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
* Others who are judged ineligible to participate in the trial by the principal investigator.
* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.
Calf Muscle Atrophy After Achilles Tendon Rupture. A Clinical-Radiological-Biomechanical Multicenter Study.

Multicenter Achilles tendon study Switzerland. Comparing three mainstream treatment types: open, percutaneous and conservative (non-operative) treatments.

Comparing force torque measurements, muscle volume and clinical scores.


Eligibility Criteria:
Inclusion Criteria:

* 20-65 years of age,
* a healthy, contralateral leg
* physiological, clinically determined alignment of the knee, foot and ankle
* no trauma to the healthy leg
* no neuromuscular impairments including muscle dystrophies
* no other posttraumatic injuries or osteoarthritis of the knee, foot or ankle of the affected leg.

Exclusion Criteria:

* re-rupture or reoperation of the Achilles tendon
* surgical site infection
* neuromuscular diseases including muscle dystrophies
* ankle valgus of more than 15° or ankle varus of more than 5°
* other known pathologies of the non-affected leg
* general MRI exclusion criteria (e.g. pacemaker, other metal not qualifying for an MRI, tattoos and claustrophobia)
* body mass index (BMI) of \> 40 kg/m2
Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurological Intensive Care

The investigators aim to compare the complications between centrally and peripherally inserted central venous catheters in neurological intensive care unit patients. The study hypothesis is that peripherally inserted catheters will have more cumulative complications due to venous thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* all patients age \> 18, admitted to the neurological ICU who are require a de novo central venous catheter as standard of care and in which a double lumen 5f PICC or CICVC (triple lumen, 7f) are acceptable for the indication.
* the patients must be expected to survive and need a central venous catheter for at least 7 days.

Exclusion Criteria:

* prisoner
* age \< 18
* expected to die or have care withdrawn prior to ICU day 7
* requiring an emergent central venous catheter
* suspected bacteremia
* recent central venous catheter within the last 30 days
* patients who are not a candidate for bedside placement of either a CICVC or PICC line
* patients with renal insufficiency with creatinine level greater than 3.0 mg/dL (265.2 m mol/L) or who were undergoing hemodialysis
* patients requiring a central venous catheter for prolonged antibiotic therapy\\
* patient who the treating clinician feels clearly needs one particular type of catheter over the other
Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery

Shoulder disorders are frequent, often associated with pain and occur in 7-34% of the general population and in 21% of the elderly population.

Of particular interest is prediction of postoperative pain after outpatient arthroscopic shoulder surgery since the clinical experience is that surgery does not always provides pain relief and the interindividual variation in acute postoperative pain intensity is significant. In addition, a Swedish study has shown that shoulder operations are associated with longer convalescence than other orthopaedic outpatient surgeries.

This study is a prospective cohort with 6 months follow-up. Patients receive 5 questionnaires (preoperatively, 24 hours, 1 week, 3 months, 6 months, 1 and 2 years after surgery). The questionnaires contain questions about:

* Preoperative shoulder pain (type, intensity and duration)
* Preoperative pain in other areas besides the shoulder
* Brief Pain Inventory (BPI)
* Western Ontario Rotator Cuff Index (WORC)
* Single Assessment Numeric Evaluation (SANE)
* 3 validated physiological questionnaires:

  * State Trait Anxiety (STAI)
  * Pain Catastrophizing Scale (PCS)
  * Hospital Anxiety and Depression Scale (HADS)

In addition a cold pressor test is performed on the day of surgery to test the patients' threshold and ability to repress pain.

Eligibility Criteria:
Inclusion Criteria:

* Arthroscopic shoulder surgery (subacromial decompression and acromioclavicular joint resection).

Exclusion Criteria:

* • \< 18 years

  * mental disorders
  * Unable to speak and/or read Danish
  * Shoulder surgery within the last year
  * Raynauds phenomenon
  * Cuff suture
  * Biceps tenodesis
  * Labrum suture
A Study of GZR4 Injection at Different Injection Sites

This trial is conducted in China. This study is a randomized, single-center, open, three-period crossover trial in healthy subjects to compare the PK, PD, and safety of a single administration of GZR4 at different injection sites (abdomen, deltoid region of upper arm, and thigh).


Eligibility Criteria:
Inclusion Criteria:

* 1. Signing the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
* 2. A Male adult subjects aged 18-55 years old.
* 3. Body mass index (BMI) between 19.0-24.0 kg/m2

Exclusion Criteria:

* 1. Known or suspected hypersensitivity to investigational medical product(s) or related products.
* 2. Participation in a clinical study of another study drug within 3 months prior to randomization.
* 3. Physical examination, vital signs, laboratory examination, imaging examination, 12-lead electrocardiogram and other auxiliary examination results that the researchers considered abnormal clinical significance during screening.
* 4. Donation of blood or blood products (more than 100mL) or significant blood loss (more than 200 mL) within 6 months prior to screening
* 5. More than 14 units of alcohol per week within 3 months prior to randomization
* 6. Smoking more than 5 cigarettes per day within 3 months prior to randomization
The Study is Being Conducted to Evaluate the Efficacy and Safety of SHR-1316 in Combination With Chemo-radiotherapy in Patients With LS-SCLC.

The study is being conducted to evaluate the efficacy and safety of SHR-1316 in combination with chemo-radiotherapy in patients with LS-SCLC.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18-75 years of age.
2. Subjects with histologically confirmed Limited-Stage SCLC without previous systematic treatment.
3. ECOG PS 0\~1.
4. At least 1 measurable lesion as defined by RECIST v1.1.
5. Adequate organ function.
6. Female subjects of childbearing potential or male subjects must be willing to use a recognized effective contraceptive measure during the study and within 3 months after the last dose of the study drug. And female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose.
7. Signed the informed consent form.

Exclusion Criteria:

1. Mixed SCLC or NSCLC.
2. Subjects who previously received systemic antitumor or Immune checkpoint inhibitor therapy.
3. Extensive-stage SCLC.
4. Subjects who is surgically resectable.
5. Subjects with malignant pleural effusion.
6. Subjects highly suspected of interstitial lung disease, or with conditions that may interfere with the testing or management of suspected treatment-related pulmonary toxicities, or other moderate to severe diseases that seriously affect pulmonary function.
7. Active, known, or suspected autoimmune diseases.
8. History of malignant tumors.
9. Subjects with severe cardiovascular disease.
10. Events of arterial/venous thrombosis within 6 months prior to the first dose.
11. Subjects with serious infection.
12. Subjects with active pulmonary tuberculosis (TB).
13. Subjects with immunodeficiency diseases.
14. Subjects with active hepatitis B virus or hepatitis C virus infection.
15. Systemic immunosuppressants administation within 14 days prior to the first dose.
16. Subjects who received major surgery within 28 days prior to the first dose.
17. Subjects who plan to receive or have received live vaccines within 28 days prior to the first dose.
18. Subjects who have previously received tissue/organ transplants.
19. Subjects with history of severe allergic reactions to monoclonal antibodies/fusion protein drugs.
20. Subjects with mental illness, alcohol abuse, inability to quit smoking, and drug or substance abuse.
A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer

Comparison of the number of ER plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms.

Using a pragmatic cluster-randomized trial design, 20 Ontario cancer centres that provide care to patients with breast cancer will be randomly allocated to one of two arms: pro-active telephone toxicity management (intervention), or control (routine care). All patients with early stage (I-III) breast cancer who commence adjuvant or neo-adjuvant chemotherapy at participating institutions during the 6 to 12-month intervention period (will vary between centres depending on the number of incident cases) will be evaluated using Ontario healthcare administrative data. A sub-set of at least 25 patients at each participating institution will participate in a PRO sub-study involving the completion of standardized questionnaires to measure: a) severity of chemotherapy treatment toxicities; b) self-care for management of chemotherapy toxicities; c) self-efficacy (confidence) for managing symptoms; d) quality of life; and e) coordination of care. Patients participating in the PRO sub-study will be asked to provide consent to link their PRO data to Ontario healthcare administrative data so that correlations between the symptom self-assessments and Quality of Life (QoL) measures can be made with the administrative data on ED+H visits and use of supportive care medications. the investigators will compare the use of supportive care medications (i.e. anti-emetics, growth factors) by patients in the intervention and control arms to assess their influence on severity of chemotherapy-related toxicities as part of an exploratory sub-group analysis in patients \>65 years of age as administrative data on supportive care medication use is only available for this age group.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years of age or older
* Diagnosis of early stage (I-III) breast cancer
* Starting adjuvant or neo-adjuvant chemotherapy within the intervention period at a participating centre

Exclusion Criteria:

* Currently participating in a clinical trial involving an investigational agent

Inclusion Criteria for PRO Sub-Study

* Willingness to participate in the study and complete PRO questionnaires as required
* Ability to understand and provide written informed consent
* Language and literacy skills consistent with completing study questionnaires
The Medtronic RESOLUTE US Clinical Trial

The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm.

The trial is comprised of four studies: the 2.25 mm - 3.5 mm main study (1242 patients), the 2.25 mm - 3.5 mm Angio/IVUS sub-study (100 patients), the 4.0 mm sub-study (60 patients), and the 38 mm Length Sub-study (114 patients). A patient's inclusion in a given study is dependent on the size (diameter or length) of the stent(s) the patient receives.

Eligibility Criteria:
General and Angiographic Inclusion Criteria highlights:

* Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
* Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
* Informed consent
* Patient agrees to comply with specified follow-up evaluations at same investigational site
* Single target lesion or two target lesions located in separate coronary arteries
* De novo lesion(s) in native coronary artery(ies)
* Target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent)
* Target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent)

General and Angiographic Exclusion Criteria highlights:

* Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; WBC count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
* Acute MI within 72 hrs of the index procedure (QWMI or any elevation of CK-MB \> lab upper limit of normal)
* Previous PCI of target vessel(s) within 9 months prior to the procedure
* Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
* History of stroke or TIA within prior 6 months
* Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
* Inability to comply with required trial antiplatelet regimen
* Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
* Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis
* Unprotected left main coronary artery disease
Research on Early Diagnosis and Clinical Transformation of Nuclide Probe Based on Bioorthogonal-gastric Cancer Mucin Target Visualization

The symptoms of early gastric cancer are extremely insidious and most patients are identified as advanced at the time of initial diagnosis. Starting from the clinical needs, this project selects solid tumors and pathogenic glycoprotein synthesis of key glycopeptide antigen determinant mucin (MUC) family of multiple molecules as the research object. Based on the digestive system tumor research cohort established in the early stage, this project intends to verify the tumor microenvironment characteristics of the MUC family and gastric cancer treatment resistance through immunohistochemistry, COSMC gene sequencing and other technologies, and screen key MUC family proteins. Based on the discovery of differential recognition of COSMC deficient cells by antibodies, MUC1-targeted specific monoclonal antibody was developed. Further development of spatial mucinomics based on laser ablation inductively coupled plasma mass spectrometry (LA-IPC-MS) and spatial metabolome based on desorption electrospray mass spectrometry (DESI-MS) to analyze the structure and immunosuppressive mechanism of key gastric cancer glycoprotein MUC. After obtaining key targeted antibodies, with the help of biological orthogonal and click chemistry technology, the original clinical translational research based on mucin targeting was carried out, and a high-affinity nuclide conjugate drug (RDC) with "triple binding" of gastric cancer mucin was constructed and clinical translational research was carried out, which provided new ideas for the accurate diagnosis and treatment of gastric cancer in the early stage.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥18 years old; ECOG 0 or 1;
2. Patients with solid tumor confirmed by histopathology;
3. Patients with imaging confirmed measurable lesions;
4. life expectancy \>=12 weeks.

Exclusion Criteria:

1. Significant hepatic or renal dysfunction;
2. ls pregnant or ready to pregnant;
3. Cannot keep their states for half an hour;
4. Refusal to join the clinical study;
5. Suffering from claustrophobia or other mental diseases；
6. Any other situation that researchers think it is not suitable to participate in the experiment.