cyrilzakka/clinical-trials huggingface dataset:
ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections

The objective of this study is to confirm superiority between a test treatment group using Endo GIA stapler with Duet Tissue Reinforcement System (TRS) and a current international standard of care group using a conventional stapler in patients undergoing pulmonary lobectomy surgery, using a randomized comparative study of the frequency of intraoperative air leak.

Air leak is a complication of pulmonary surgical procedures that include pulmonary lobectomy, segmentectomy, and bullectomy, reported to occur in 33% to 75% of cases.

Prolonged air leak continuing for more than 7 days is reported to have a prevalence of greater than 15%. The presence of a history of smoking, preoperative steroid use, emphysema, low pulmonary function, pleural adhesion, and apical lung wedge resection are shown to be risk factors for prolonged air leak which lengthens the duration of drain placement, increases the days of hospitalization, and reduces patient ADL and QOL. Prolonged air leak may also result in serious complications, such as empyema.

Tissue reinforcement materials widely used as a pleural reinforcement to prevent air leaks during lung surgery, and are reported as a safe and effective material for body tissue reinforcement. Covidien Japan Inc. has developed a surgical stapler (Endo GIA Duet TRS) with an attached reinforcement material. This study will investigate the reinforcement effect on the staple line of using the newly developed surgical stapler with an attached reinforcement material.

Eligibility Criteria:
Inclusion Criteria:

* The patient is between 20-79 years of age.
* The patient is eligible to be given pulmonary Lobectomy.
* The patient is scheduled to undergo pulmonary Lobectomy.
* Performance status 0\~1 (Eastern Cooperative Oncology Group classification).
* The patient has no history of lung surgery.
* The patient is healthy organ function.
* The patient is scheduled for surgery with staplers .
* The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

Exclusion Criteria:

* The patient has suffered thoracic trauma or has previously undergone pneumonectomy surgery.
* The patient has an active bacterial infection or fungal infection.
* The patient is undergoing continuing systemic administration (intravenous or oral) of steroids.
* The patient condition is complicated by uncontrolled diabetes mellitus.
* The patient participation is judged difficult due to study complications related to a psychiatric disorder or psychological symptoms.
* The patient undergoes surgical procedure other than lobectomy during surgery.
* Reinforcement material other than the study materials are applied during surgery.
* The patient judged unsuitable for study participation by the investigator for any other reason.
Neoadjuvant Almonertinib Followed by Chemo-immunotherapy in II-IIIB EGFR-mutant NSCLC

Phase II, single-arm, open-label study that assess clinical feasibility and safety of neoadjuvant almonertinib followed by 3 cycles neoadjuvant adebrelimab plus chemotherapy in EGFR-mutant stage IIA-IIIB NSCLC followed by surgery, adjuvant treatment was upon investigators' decisions.

This study plans to include 32 eligible II-IIIB non small cell lung cancer (NSCLC), patients will receive 6 weeks of almonertinib, and to avoid overlap of interstitial lung disease (ILD) and immune-related pneumonitis, 2 weeks of washout period was designed before 3 cycles of adebrelimab + doublet platinum-based chemotherapy is administered. Dynamic blood samples before, during or after neoadjuvant treatment will be obtained for exploratory analysis. Patients with local disease and resectable or potentially resectable NSCLC will receive anatomic resection. Patients who progress upon neoadjuvant treatment and further assessed as unresectable disease will be scheduled for local radiation or other potential subsequent treatment regarding multidisciplinary discussion. After completion of local treatment (surgery or radiation), patients will undergo optional adjuvant treatment including epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) or immunotherapy upon investigators' consideration or CT surveillance. Patients will be follow-up within 5 years after surgery. The primary endpoint of this study is major pathological response (MPR) defined as no more than 10% residual tumor found in primary lung cancer as per International Association for the Study of Lung Cancer (IASLC) criteria.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female，Age: 18 Years and older,
2. Subjects voluntarily joined the study and signed informed consent,
3. pathological proven resectable stage II-IIIB non small cell lung cancer (AJCC 8th edition),
4. ECOG PS=0 or 1,
5. resectable or potentially resectable, or resectability discussed by MDT,
6. harboring EGFR mutation: Ex19del, L858R, T790M, G719X, Exon20 insertions, S768I or L861Q
7. measurable lesion as per RECIST1.1.

Exclusion Criteria:

1. pathologica or cytological proven small cell lung cancer, mixed small cell lung cancer or other than non small cell lung cancer,
2. non small cell lung cancer harboring other driver gene alteration with approved targeted drugs,
3. with malignant plural effusion,
4. previous treatment to non small cell lung cancer other than this regimen,
5. received thoracic radiotherapy,
6. currently enrolled in other clinical trial,
7. active or known or suspected autoimmune disease.
Effect of Dipeptidyl Peptidase-IV Inhibitor and Sulfonylurea on Glucose Variability and Oxidative Stress

This research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin

Sitagliptin might improve not only the mean glycemic control during study period but also 24 hour glycemic fluctuation by restoring the physiologic pattern of insulin secretion. Furthermore decrease postprandial glycemic excursion should decrease the oxidative stress markers. Those effects might be amplified in Asian patients because of prominent early phase insulin secretory defects accompanied with relatively less degree of insulin resistance. Based on this assumption, this research will focus on the effect of Sitagliptin on 24 hour glycemic excursion and improvement of oxidative stress markers compared to long acting sulphonylurea Glimepiride in type 2 diabetic patients with inadequate glycemic control on metformin.

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes
* duration of diabetes less than 10 years
* HbA1c 6.5-8.0%
* BMI 20-30
* on stable dose of metformin (more than 1000mg) for at least 2 months

Exclusion Criteria:

* having oral hypoglycemic agents other than metformin
* using insulin
* serum creatinin \>= 1.5 mg/dL
* SGOT, SGPT \>= 90
* ischemic heart disease
* congestive heart failure (NYHA class \>=2)
* severe diabetic complication (PDR, CRF, CVA)
* on medication affecting glucose profile (such as steroid)
* infectious disease
* malignancy
* pregnant or breast-feeding woman
System Accuracy of BGM GL60

This study assesses the system accuracy a blood glucose monitoring systems pursuant to ISO 15197

This study assesses the system accuracy ofthe blood glucose monitoring systems for personal use GL60 as outlined in DIN EN ISO 15197:2015.

Eligibility Criteria:
Inclusion criteria:

* Male or female patients with hypo-, eu- or hyperglycaemia
* The written informed consent had to be signed
* The volunteers must be older than 18 years
* The volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved

Exclusion criteria:

* Pregnancy or lactation
* Acute or chronic diseases with the risk of aggravation by the measure
* A current constitution that does not allow participating in the study
* Participation in another study or activity with the blood glucose measuring system evaluated in the present study
* Application of substances listed in Appendix A of DIN EN ISO 15197:2015
A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Properties and Immunogenicity of 9MW3811 in Healthy Subjects

This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants between 18 and 55 years of age, inclusive.
2. Male body weight ≥50.0 kg, or female body weight ≥45.0 kg, and body mass index (BMI) between 18.0 and 26.0 kg/m2, inclusive.
3. In good health determined by the investigator based on a medical evaluation.

Exclusion Criteria:

1. Clinically significant histories determined by the investigator of cardiovascular, hepatic, renal, gastrointestinal, neurological, respiratory, hematological, endocrinological, immunological, metabolic, and musculoskeletal abnormalities.
2. Having any history of an allergy to biological agents or any components of study drug; those who have a history of allergies and judged by the investigator to be ineligible for enrolment.
3. Use of any prescription medication 14 days prior to dosing or over-the-counter medication, vitamins, and/or herbal medicines 7 days prior to dosing (Excluding oral contraception, occasional paracetamol, ibuprofen and standard dose of multivitamins at the discretion of the PI or designee)
4. Participants who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study
5. Participants who received immunosuppressants except for previous use of inhaled or nasal corticosteroids 4 weeks earlier before administration or any oral corticosteroids 8 weeks earlier before administration, and who had received a single dose of monoclonal antibodies for any reason within 1 year prior to screening
6. Participants with one or more clinically significant positive test results of hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody or human immunodeficiency virus (HIV) antibody
7. History of active tuberculosis, or participants with active or latent tuberculosis infection during screening
8. History of drug abuse including narcotic and psychiatric drugs within 6 months prior to screening or a positive drug abuse test result at baseline (Morphine, Methamphetamine, Tetrahydrocannabinol acid)
Needless Laser Injector for Antiaging Effect of Dermal Filler

The investigators aimed to evaluate the efficacy and safety of needless laser injector for antiaging effect of dermal filler.

A 24-week prospective, single-center, assessor-blinded, randomized, split-face study was conducted to compare the clinical efficacy and safety of needless laser injector versus needle injection for anti-aging effect of dermal filler.

Eligibility Criteria:
Inclusion Criteria:

* patients who wanted to improve facial skin aging

Exclusion Criteria:

* a history of skin rejuvenation treatment (including filler, botulinum toxin, lasers, chemical peeling, and topical retinoid) within 6 month prior to the start of the study
* having a plan for skin rejuvenation treatment during the study
* current pregnancy or breastfeeding
* an allergy to polylactic acid (PLA) or hyaluronic acid (HA)
* uncontrolled medical diseases
Oral Bacteria on Suture Materials - Clinical Comparison of an Antibacterial-coated and a Non-coated Suture Material

Antibacterial Triclosan-coated suture material (VICRYL PLUS®, Ethicon) and non-coated (VICRYL®) was compared for bacterial colonization after third molar extraction. Sutures were removed postoperatively and adhered bacteria were investigated.


Eligibility Criteria:
Inclusion Criteria:

* planned surgical extraction of 1 to 4 wisdom teeth
* no inflammation and pain within the planned surgical area
* legal age
* clinically healthy patient

Exclusion Criteria:

* allergy to Triclosan or phenols
* gravidity/lactation
* immunosuppression due to drugs or diseases
* severe general diseases
* long-term medication
* intake or use of other antibiotical drugs/devices
Total Lymphoid Irradiation Pre-HSCT in Severe Congenital Neutropenia

Severe congenital neutropenia (SCN) is a group of primary immunodeficiencies caused by distinct gene mutations and characterized by neutrophil maturation impairment, which leads to neutropenia, predisposition to severe bacterial and fungal infections, and myeloid malignancies. Granulocyte-colony stimulation factor is used for pathogenetic therapy, however, no adequate response is seen in some patients.

The only curative option for SCN is hematopoietic stem cell transplantation (HSCT). An indication for HSCT in SCN is: no adequate response to G-CSF therapy, or development of malignancies, or found unfavorable mutations of SCN genes, leading to poor response to G-CSF and high risk of malignant transformation.

One of the major peculiarities of HSCT in SCN is a high risk of graft failure. That was described in few studies in SCN transplantation and was also observed in our SCN HSCT cohort. We also consider the role of TCRab/CD19 graft depletion, which is routinely used in our center for GVHD prophylaxis in increased risks of graft failure.

Another problem often observed in our patients is the relatively high risks of death of infections, developed after graft failure.

Due to predominantly early HSCT graft failure development, non-sufficient immuablation is presumed as the main reason for graft failure. Because of the low level of toxicity, associated with TCRab/CD19 depletion usage, this strategy is planned to be used in the current study. To increase an immunoablative potential of conditioning regimen in SCN, total lymphoid irradiation will be studied in combination with myeloablative agents and standardly used serotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical indications for HSCT in SCN: clinical diagnosis of SCN with (1) no adequate response to G-CST therapy or (2) with malignant transformation or (3) unfavorable mutations of known SCN genes
* GATA2 deficiency
* SCN patients age at HSCT 18 months - 21 years
* GATA2 deficiency patients age at HSCT more than 10 years
* Signed informed consent to participate in the study
* Presence of HLA-matched unrelated or HLA-mismatched related donor

Exclusion Criteria:

* Presence of HLA matched related donor in absence of pathologic SCN gene mutation
* Inability to perform TCRab/CD19 graft depletion
* Contraindications for HSCT due to patients somatic condition
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.

Up to 70 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.

Eligibility Criteria:
Inclusion Criteria:

* A male or female patient with a clinical diagnosis of BA
* Age at Kasai HPE ≤90 days
* Eligible to start study treatment within 3 weeks post-Kasai HPE

Key Exclusion Criteria:

* Patients with intractable ascites
* Ileal resection surgery
* ALT ≥10× upper limit of normal (ULN) at screening
* Patients reliant only on total parenteral nutrition, or not able to take study medication orally, at randomization
* Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
* Choledochal cystic disease
* INR \>1.6 (the patient may be treated with Vitamin K intravenously; sample may be redrawn and if INR is ≤1.6 at resampling the patient may be randomized)
* Any other conditions or abnormalities, including congenital abnormalities, major cardiac surgery, hepatic, biliary, or GI disease which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the patient, the integrity of study results, or patient compliance with study requirements
* Weight \<3.5kg at randomization
A Phase III Study of Travoprost/Timolol Combination in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of this study is to demonstrate equivalent safety and IOP-lowering effectiveness of two Travoprost/Timolol combination products in patients diagnosed with open-angle glaucoma or ocular hypertension. This global study will be conducted in the US (C-07-64, NCT00672997) and Japan (C-08-08, NCT00760539).


Eligibility Criteria:
Inclusion Criteria:

* Open-angle glaucoma or confirmed ocular hypertension.
* Mean IOP in at least one eye, the same eye(s):22-36 mmHg at 9 AM on eligibility visits 1 \& 2 and 21-36 mmHg at 11 AM and 4 PM on Eligibility Visits 1 \& 2.
* Sign an informed consent form.
* Discontinued use of all IOP-lowering medications(s) for a minimum of 4 days to a minimum of 27 days or more prior to the Eligibility 1 Visit.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential who are pregnant, planning to become pregnant during the study period, breast-feeding, or not using adequate birth control measures.
* Any form of glaucoma other than open-angle glaucoma (with or without a pigment dispersion or pseudoexfoliation component) or confirmed ocular hypertension.
* History or current evidence of chronic or recurrent severe inflammatory eye disease in either eye.
* History or current evidence of clinically relevant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment in either eye.
* Best-corrected visual acuity (BCVA) worse than 0.6 logMAR in either eye.
* Severe central visual field loss in either eye.
* Not able to safely discontinue use of all IOP-lowering ocular medication(s) according to the Ocular Hypotensive Medication Washout Schedule.
* History or current evidence of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) that would in the opinion of the investigator preclude the safe administration of a topical beta-blocker.
* History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for the study.
* Other protocol-defined exclusion criteria may apply.
Study of Extracellular Vesicles (EV) in Patients Undergoing CAR-T Cell Therapies

Patients with refractory/relapse hematologic oncology disease may benefit from innovative therapy such as Car-T cells. Factors strongly predictive of outcome and response are unknown. Extracellular vesicles are recognized as a mode of intercellular communication and are reminiscent of the cell of origin. They are currently candidates to be biomarkers for this biomarker of phenomena occurring in tissues. The working hypothesis is that they may be predictive of outcome and toxicity, as some preliminary data have suggested.

Therefore, the aim of the study concerns I dentification of potential CAR-EV biomarkers associated with neurological toxicity after infusion of CAR-T cells.


Eligibility Criteria:
Inclusion Criteria:

* patients affeccted by any hematological malignancies (r/r B cell lymphoma, B cell acute leukemia and multiple myeloma) undergoing (or whit indication to) CAR-T cell infusion with a CAR-T cell product;
* age: 18 years or greater;
* obtained written consent to the study participation.

Exclusion Criteria:

* none
Implementation and Effectiveness of the BJC-Pink and Pearl Project on Lung Cancer Screening

The investigators proposal is ripe for executing as the investigators seek to leverage this "natural experiment" initiated by the BJC health system to evaluate the effectiveness of the Pink \& Pearl Campaign as an implementation strategy to promote lung cancer screening (LCS) uptake among LCS-eligible women undergoing mammography at BJC West County. This evaluation is grounded in the Integrated Screening Action Model that depicts individual- and environmental-level influences on the screening behavior process. Using an explanatory sequential mixed methods design, which combines both quantitative and qualitative approaches, the research questions and specific aims for this proposal are to: a) evaluate the baseline prevalence of LCS among LCS-eligible women; b) assess whether the Pink \& Pearl Campaign increases referrals and uptake/ completion of LCS among LCS-eligible women undergoing screening mammography; and c) evaluate individual and environmental factors influencing LCS uptake, and implementation outcomes of the campaign. These implementation outcomes will help identify whether the campaign was put in place successfully or not. This proposal will inform strategies for integrating cancer screening programs to improve poorly performing programs like LCS.


Eligibility Criteria:
Inclusion Criteria for Participants:

* Undergoing screening mammography
* Between the ages of 50-80 years (inclusive)
* Reporting a 20 pack-year equivalent of either current smoking history or have quit in the past 15 years
* Can speak and understand English
* Ability to understand willingness to provide informed consent.

Exclusion Criteria for Participants:

* Diagnosed with a serious health problem that will likely limit life expectancy (such as previous history of lung cancer, symptoms of lung cancer such as hemoptysis or unexplained weight loss of more than 6.8 kg (15 lb) in the previous year)

  * Subjects with symptoms of lung cancer should get a diagnostic CT scan
* Unable or unwilling to get treatment if lung cancer is found

Eligibility Criteria for Providers:

* Older than 20 years of age