cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Tonabersat for DME

This randomized clinical trial will evaluate the effect of tonabersat compared with placebo on central subfield thickness (CST) in eyes with center-involved diabetic macular edema (CI-DME) and good visual acuity.

The primary objective is to assess the effects of tonabersat, an orally administered Connexin43 hemichannel inhibitor, on central subfield thickness (mean change) compared with placebo in eyes with CI-DME and good visual acuity at 6 months.

Exploratory objectives will evaluate biomarkers of kidney function for potential benefit. Furthermore, this phase 2 study is being conducted to determine whether the conduct of a phase 3 trial has merit and provide information on outcome measures needed to design a phase 3 trial.

Eligibility Criteria:
Key Inclusion Criteria

1. Adults with type 1 or 2 diabetes mellitus
2. At least one eye with:

   * Best corrected E-ETDRS visual acuity letter score ≥ 74 (i.e., 20/32 or better)
   * Ophthalmoscopic evidence of center-involved DME in study eye confirmed by central subfield thickness on spectral domain OCT
   * Zeiss Cirrus: ≥ 290 µm in females, ≥ 305 µm in males
   * Heidelberg Spectralis: ≥ 305 µm in females, ≥ 320 µm in males

     * Recruitment will be monitored with a goal to have equal proportions in the following categories above the CI-DME thresholds: \<75 μm, 75 μm to \<175 μm, ≥175 μm
3. Media clarity, pupillary dilation, and study participant cooperation sufficient for adequate OCT

Key Exclusion Criteria

* Macular edema is considered to be due to a cause other than DME
* Major ocular surgery within prior 4 months, or anticipated after randomization
* History of focal/grid laser or other ocular surgical, intravitreal, or peribulbar treatment for DR or DME within prior 1 year, and no more than 4 anti-VEGF injections within prior 3 years
* Anticipated need to treat DME or DR during the first 6 months, or anticipated need for cataract surgery during study period
* Any history of vitrectomy
* Systemic anti-VEGF or pro-VEGF treatment within 12 months prior to randomization
* History of chronic renal failure requiring dialysis or kidney transplant
* History of moderate to severe hepatic impairment, including known liver function test (LFT) values \> 3x's the upper limit of normal
Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This is a prospective observational study of infants born at \< 30 weeks of gestation. The primary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in premature infants with PDA in comparison to infants without PDA. The secondary aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Infants \< 30 weeks estimated gestational age

Exclusion Criteria:

* Infants with major congenital anomalies
* Infants \>34 weeks post-menstrual age
A Pre-endoscopic Prediction Model for Inadequate Bowel Preparation in Patients Receiving Split Dose Polyethylene Glycol Preparation

After written consent for participating in clinical research studies, all clinical studies conducted to in the one day. The investigators will ask and record about bowel cleansing state in all patients who performed colonoscopy. There is no additional cost and the expected complications.

Based on answer, the investigators will develop a prediction model for inadequate bowel preparation and prove validation. This model can take the additional measures to subjects predicting improper cleansing. It can contribute to improve the accuracy of the test and reduce the discomfort due to re-performing colonoscopy after re-preparation, as well as cost savings due to reduced frequency of re-colonoscopy Ultimately, it will be able to bring a improvement of the quality of management


Eligibility Criteria:
Inclusion Criteria:

* Adults over 20 years old

Exclusion Criteria:

* Less than 20 years old
* Cardiac, renal, and metabolic dysfunction in patients with serious adverse
* Mental or central nervous system disorders
* Individuals with bwel obstruction
* Individuals who can not read and understand the consent form (literacy, foreign, etc.) However, although individuals with vision / hearing disturbance and deterioration of cognitive abilities, they may participate in the research if can be able to complete the survey with one guardian or the help of researchers.
A Phase 1/2 Trial of ADI-270 in CcRCC

This is a Phase 1/2 multicenter, open-label, dose escalation, and dose expansion study of ADI-270 - an Engineered gamma-delta Chimeric Receptor \[CAR\] Vδ1 T Cell product Targeting CD70 - in patients with R/R ccRCC.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confirmed clear cell RCC
2. Documented evidence of advanced or metastatic diseases.
3. Patients must have been treated with an immune checkpoint inhibitor and a VEGF inhibitor (the VEGF inhibitor must have been administered in the advanced and/or metastatic setting).
4. At least one measurable target lesion according to RECIST 1.1
5. At least three weeks, or 5 half-lives, whichever is shorter, from the last dose of the prior line of systemic therapy
6. KPS ≥ 70

Exclusion Criteria:

1. Subjects with CNS metastases or spinal cord compression are not eligible, unless they have completed therapy and have discontinued the use of corticosteroids for at least 8 weeks and remained stable prior to enrollment.
2. Clinically significant CNS dysfunction of any etiology in the opinion of the Investigator.
3. Prior radiation therapy within 21 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions (palliative radiotherapy to bone lesions must be completed at least 2 weeks prior to the first dose of LD).
4. Active malignancy (except for RCC, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past 24 months
5. Treatment with gene therapy, genetically modified cell therapy, or adoptive T cell therapy within 6 weeks before initiating LD in this study.
6. Receipt of CD70 targeted therapies for any indication
7. Require corticosteroid therapy \> 5 mg per day of prednisone or equivalent.
8. History of any form of primary immunodeficiency such as severe combined immunodeficiency disease.
9. Presence of active autoimmune disease requiring ongoing systemic immunosuppressive therapy.
Aveir AR Coverage With Evidence Development (CED) Study

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Atrial Leadless Pacemaker device (aka Aveir™ AR LP system).

This CED study utilizes a real-world evidence (RWE) method merging multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir AR LP health outcomes among Medicare beneficiaries.

The study will enroll all Medicare patients with continuous claims data implanted with the Aveir AR LP or a single-chamber atrial transvenous pacemaker system from any manufacturer.

Due to the RWE data collection methods used in this study, a central institutional review board (IRB) approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.

Eligibility Criteria:
Inclusion Criteria:

1. Medicare beneficiaries implanted with an Aveir AR leadless pacemaker on or after the study start date (i.e., the date of Aveir AR market approval) will be included in the study.

   OR
2. Medicare beneficiaries implanted with a full system (e.g. lead and generator) single chamber atrial transvenous pacemaker on or after the study start date

Exclusion Criteria:

* None
Uncontrolled Donation After Circulatory Determination of Death (uDCDD)

World-wide, patients waiting for organ transplantation exceed the number of organs available. Many European countries have a uDCDD program which contribute to 10-15% of the donor pool. In Canada, this type of program does not exist. The purpose of this study is to report how many deceased person fulfill the criteria for uncontrolled DCDD in a Canadian medical center.

While transplantation has become the definitive treatment for many people suffering end-stage organ failure, demand exceeds supply. For many years, donation after neurological death represented the principal source of organs for transplantation. In the last decade, prevention measures, improvements in neurocritical care, and decompressive craniectomy have led to a significant decrease in the number of non-directed donors (NDDs). In such situations, alternative sources for organ donation must be identified. Cardiac-arrest patients could provide a solution to this organ shortage. Patients who have experienced unexpected in or out of hospital cardiopulmonary arrest could become organ donors. Organ donation following uncontrolled cardiocirculatory death is currently practiced in many European countries. However, in Canada, it's not yet authorized. Yet, each deceased could save up to four lives. The purpose of this study is to determine the organ potential for a cohort of patient who had died from a cardiopulmonary arrest at the CHUS in 2015 and assess the effect of the implementation of a uDCD program on the number of additional donors.

Eligibility Criteria:
Inclusion Criteria:

* All patients treated for cardiocirculatory arrest at the CIUSSS-Estrie CHUS in 2015.

Exclusion Criteria:

* Patients with a status of no resuscitation
* Pediatric patients (\<18 years old)
* Adults \>65 years old
Feasibility of Uninterrupted Infant Respiratory Support Treatment

Feasibility study of a simplified respiratory support system for newborn infants

The study is a "proof-of-concept" feasibility trial that evaluates usage of a simplified respiratory support system for newborn infants. The study aims to evaluate both the feasibility of providing uninterrupted support for the first hours of life as well as a modified respiratory support system.

The system is a modified version of the commercially available rPAP system. The revised design has a simplified gas supply and allows elimination of a complicated driver. The new system has low resistance to breathing equal to the rPAP system. The study will recruit 40-60 infants in a single centre without a comparison arm.

The trial is conducted as a first step towards a large randomised trial.

Eligibility Criteria:
Inclusion Criteria:

* Vaginal delivery at gestational age between 28+0 and 34+6
* Caesarean section at gestational age between 28+0 and 37+6
* Infants in need of respiratory support in delivery-room

Exclusion Criteria:

* Carciac malformations
* Airway malformations
* Known syndromes or neuromuscular disorders
* Transfer to other hospital within 4 hours likely
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.


Eligibility Criteria:
Inclusion Criteria:

1. Are ≥ 18 years of age at the Screening Visit.
2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
3. Have a QMG score ≥ 11 at the Screening and Baseline Visits.
4. Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.
5. Additional inclusion criteria are defined in the protocol.

Exclusion Criteria:

1. Have experienced myasthenic crisis within 3 months of the Screening Visit.
2. Have had a thymectomy performed \< 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
3. Have any active or untreated malignant thymoma.
4. Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies) within the past year.
5. Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRn treatment.
6. Additional exclusion criteria are defined in the protocol.
Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)

Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive reflux disease(NERD)


Eligibility Criteria:
Inclusion Criteria:

* subjects who signed written informed consent form
* more than 20 yr subject
* subjects who agree the use of medically accepted birth control during trial
* grade N, M by EGD test
* subject who experience 2 day out of 1 week during recent 1 month
* subject who experience 2 day out of 1 week during run-in period

Exclusion Criteria:

* subjects who can write the diary by himself, herself
* pregnant woman, breastfeeding woman
* allgeric or intolerabiliy to revaprazan or esomeprazole
* feeling of heavy stomach, distention
* surgery history in stomach or esophagus
* active medical history of stomach, esophagus area
* other system disorder which can disturb this trial
* Hep B, C virus, HIV carrier or patients
* past history of malignant tumor
* any psychiatric past or current history
* abnormal lab test
* abnormal ecg test
* zollinger-ellison disease
* current or past history of substance, drug abuse
* subject who should regulary takes medication which can disturb this trial
Interest of Bone Scintigraphy in the Search for Scaphotrapezoidal Osteoarthritis

Rhizarthosis can be treated by prothesis of the carpo-metacarpal (CM) joint of the thumb. But, if the scaphotrapeziotrapezoid (STT) joint is also affected by arthrosis, treating the CM joint exclusively may result in partial pain relief. Thus, bone scintigraphy could identify early arthrosis of the STT joint when its appearance seems to be normal on planar radiography, suggesting another surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* failure of medical treatment of rhizarthrosis
* eligibility for prothesis
* no osteoarthritis of the STT joint on planar radiography
* no opposition from the patient

Exclusion Criteria:

* Refusal by a patient
Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)

Immunotherapy shows satisfactory effectiveness and safety in patients with esophageal cancer. Immunotherapy-based regimens have a better survival benefit compared to previous chemotherapy and radiotherapy. Patient-reported outcomes (PRO) provide a reliable assessment of patients' functional status during treatment. However, the spectrum of symptoms in esophageal cancer patients receiving immunotherapy is uncertain, and there are no studies applying the symptom bank based on PRO to the immunotherapy model for esophageal cancer. In this prospective study, the investigators aimed to preliminarily screen for symptoms associated with immunotherapy for esophageal cancer through a systematic literature review and expert evaluation, and build a symptom item bank for esophageal cancer patients receiving immunotherapy. Adverse symptoms in esophageal cancer patients treated with immunotherapy were collected prospectively. The distribution and severity of the symptoms, as well as the trajectory of symptom change were further analyzed to demonstrate the validity and reliability of the symptom item bank. It would refine the spectrum of symptoms for esophageal cancer patients receiving immunotherapy and provide a foundation for assessing the specific symptom burden in patients with esophageal cancer receiving immunotherapy regimens.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed resectable, locally advanced, advanced metastatic esophageal cancer
* Having received or undergoing an immunotherapy-based treatment regimen
* Age 18-75 years
* ECOG PS of 0-2
* Adequate organ function
* Life expectancy \> 6 months
* Participants are fully informed about the whole study and are willing to sign the informed consent

Exclusion Criteria:

* Absence of immunotherapy regimen, or recieving radiotherapy.
* Presence of primary tumours elsewhere, such as gastric cancer, lung cancer or cervical cancer
* Severe organ function deterioration and intolerance to immunotherapy
* Pregnant or breast-feeding women
* Previous autoimmune disease
* Any other conditions that may affect patients' safety and compliance
* Psychological, family, social and other factors leading to inability to inform consent
NKG2D-CAR-NK92 Cells Immunotherapy for Solid Tumors

The purpose of this clinical investigation is to evaluate the safety and effects of NKG2D-CAR-NK92 infusions in the treatment of relapsed/refractory solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥ 18 years old and ≤ 75 years old, male or female.
2. Histopathology confirmed the diagnosis of malignant tumors (including breast cancer, lung cancer, gastric cancer, ovarian cancer, cervical cancer, renal carcinoma, malignant melanoma, osteosarcoma and lymphoma).
3. Expected survival time ≥3 months.
4. Disease must be measurable according to the corresponding guidelines.
5. Fail or unwilling to receive third-line treatment.
6. ECOG: 0-2.
7. The last cytotoxic drug, radiotherapy or surgery≧4 weeks.
8. HB≧90g/L, ANC≧1.5×10\^9/L, PLT≧80×10\^9/L, TBIL≦1.5×upper limit of normal, ALT/AST≦2.5×upper limit of normal, ALT/AST≦5×upper limit of normal if have liver metastasis, Cr≦1.5×upper limit of normal or CCr≧60ml/min.
9. Women of childbearing age must be tested negative for pregnancy within 7 days, and subjects of childbearing age must use appropriate contraception during both the trial and for 3 months after the test;
10. Written informed consent form must be signed before enrollment.
11. Patient with MICA/B+ cell tumors confirmed by pathology and histology.

Exclusion Criteria:

1. The patient has other malignancies or has been diagnosed with other malignancies within the last 5 years (except clinically cured carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, and thyroid papillary carcinoma).
2. Patients with brain metastases with symptoms or with symptom control for less than 3 months.
3. Active autoimmune disease.
4. Severe autoimmune diseases or congenital immunodeficiency.
5. Concomitant serious infection or other serious underlying medical condition.
6. Active hepatitis patients (including hepatitis B and C).
7. History of severe immediate hypersensitivity to any of the biological products including penicillin.
8. Drug abuse, medical, psychological or social conditions that may interfere with a subject's participation in the study or evaluation of the results of the study.
9. Simultaneous participation in another clinical trial within 4 weeks.
10. Cell therapy or gene therapy in the previous 1 month.
11. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation.
12. Investigator considers that the subject has any clinical or laboratory abnormalities or compliance problems and is not suitable to participate in this clinical study.
Comparison of Vitamin D Status and Vitamin D Receptor Polymorphisms in Patients With High Myopia and Primary Open-angle Glaucoma

Vitamin D deficiency is known to be significantly associated with high myopia. This study investigated the vitamin D status in patients with high myopia and primary open-angle glaucoma, in order to understand the relationship between high myopia and the development of primary open-angle glaucoma.110 primary open-angle glaucoma patients, 110 high myopia patients and 110 age-matched people in the Han population were enrolled. Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay.Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique.


Eligibility Criteria:
Inclusion Criteria:

-primary open-angle glaucoma (1) intraocular pressure above 21 mmHg or more in each eye without therapy; (2) wide anterior chamber angle; (3)glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect in at least one eye;(4) visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry in at least one eye.

c(with refractive error \>6D) were recruited.

Exclusion Criteria:

* the presence of any secondary glaucoma with an exfoliation syndrome or a history of ocular trauma, high myopia, macular degeneration, other ocular diseases, and also a known history of systemic diseases and administration of vitamin D3 or other analog.

High myopia patients with ocular disease such as glaucoma, a history of administration of vitamin D3 or other analog or a history of retinopathy or connective tissue disorders associated with myopia, such as Stickler or Marfan syndromes, were not included.