cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Clinical Efficacy and Safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in Patients With Branch Retinal Vein Occlusion (BRVO)

This is a phase III, double-masked, randomized, active-controlled, parallel-group, 52-week study to assess the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) compared to laser treatment in patients with macular edema secondary to BRVO.


Eligibility Criteria:
Inclusion Criteria:

The following inclusion criteria include, but are not limited to:

1. Adults ≥ 18 years of age with foveal center-involved macular edema (ME) secondary to BRVO diagnosed within 12 months before the screening visit
2. ETDRS BCVA: letter score of 73 to 24 (20/40 to 20/320) in the study eye at screening and at day 1
3. Provide signed informed consent

Exclusion Criteria:

The following exclusion criteria include, but are not limited to:

1. Current bilateral manifestation of BRVO
2. Uncontrolled glaucoma defined as ≥ 25 mmHg on optimal medical regimen, or previous filtration surgery in either the study eye or the fellow eye
3. Insufficient clearing of macular hemorrhage that would prevent the patient from receiving laser treatment safely on day 1 (patients that meet this criterion may be rescreened once the macular hemorrhage resolves)
4. Uncontrolled diabetes mellitus (DM)
5. Previous use of intraocular corticosteroids or anti-angiogenic drugs in the study eye
6. Use of periocular corticosteroids in the study eye within 3 months before day 1
7. Use of intraocular or periocular corticosteroids or anti-angiogenic drugs in the fellow eye within 3 months before day 1
8. Previous administration of systemic anti-angiogenic medications
9. Panretinal scatter photocoagulation, sector laser photocoagulation, or macular grid photocoagulation in the study eye
Effect of Removal of Double Antibiotic Paste on Post Operative Pain

Recruited patients with necrotic pulp after application of double antibiotic paste are assigned to group (XP Endo Finisher file) and group( Passive ultrasonic irrigation) and group (conventional syringe irrigation with side vented needle) to remove intracanal medication and record postoperative pain afterwards.

The investigator will recruit patients who are found eligible to the criteria, double antibiotic paste will be inserted inside the canals. After 7 days, patients will be randomly assigned to either removal of intracanal medication using, the XP-Endo Finisher file, passive ultrasonic irrigation (PUI) and conventional syringe irrigation with side vented needle.

After the visit, patients will be asked to record post operative pain by Visual Analog Scale)in a given sheet

Eligibility Criteria:
Inclusion Criteria:

* Medically free patients.
* Patient's age between 20-50 years.
* Both sexes.
* Necrotic pulp as indicated by thermal or electric pulp testing.
* No history of previous endodontic treatment of the tooth.
* Enough crown structure for adequate isolation.

Exclusion Criteria:

* Pregnancy or lactation
* Medically compromised patients
* Previous endodontic therapy of the affected tooth.
* Teeth diagnosed with vital pulp.
* Teeth with periodontal pocket more than 3mm deep.
* Teeth with abnormal anatomy or calcified canals.
* Teeth with caries below the bony level (non-restorable tooth).
* Immature teeth with open apices.
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer

For unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.


Eligibility Criteria:
Inclusion Criteria:

1. The patient shall sign the Informed Consent Form.
2. Aged 18 ≥ years.
3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS).
4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1.
5. Life expectancy is at least 12 weeks.
6. At least 1 measurable lesion according to RECIST 1.1.
7. Patients with good function of other main organs (liver, kidney, blood system, etc.)
8. Patients with normal lung function can tolerate surgery;
9. Without systematic metastasis (including M1a, M1b and M1c);
10. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative.
11. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later).

Exclusion Criteria:

1. Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment;
2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases;
3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment;
4. Participants who are allergic to the test drug or any auxiliary materials;
5. Participants with Interstitial lung disease currently;
6. Participants with active hepatitis B, hepatitis C or HIV;
7. Pregnant or lactating women;
8. Participants suffering from nervous system diseases or mental diseases that cannot cooperate;
9. Participated in another therapeutic clinical study;
10. Other factors that researchers think it is not suitable for enrollment.
Dynamic PET acquisition-a Quantitative Technique for Grading of Malignant Tumors and Prediction of Response to Treatment

To assess a quantitative kinetic model of FDG uptake measurement using PET in patients with aggressive Non-Hodgkin's lymphoma and cancer of the pancreas, malignancies with known variability in disease aggressiveness and prognosis, for optimized tailoring of the therapeutic strategy in the individual patient.


Eligibility Criteria:
Inclusion Criteria:

* age\>18
* newly diagnosed untreated aggressive NHL
* newly diagnosed untreated cancer of pancreas

Exclusion Criteria:

* none
Application of Mobile DR in the Diagnosis of Bone Trauma in High Cold Environment

In the high cold environment, mobile digital radiography (DR) is used to collect the imaging of bone injury patients, and the artificial intelligence diagnosis module is used to diagnose the injury. The quality of images obtained by mobile or conventional DR and the consistency between artificial intelligence and pure artificial diagnosis will be analyzed respectively. Finally, the application value of mobile DR loaded with artificial intelligence diagnosis function in high cold environment is determined.


Eligibility Criteria:
Inclusion Criteria:

* Patients with new bone injury

Exclusion Criteria:

* Life threatening.
* Head injury and fracture.
* There are congenital malformations in the bone injury site.
A Smoke-Free Home Intervention in Tribal Communities

This clinical trial evaluates a smoke-free home intervention for reducing exposure to secondhand smoke from commercial tobacco in homes of participants who live in rural tribal communities. Smoke-free homes are an innovative and relatively untapped strategy for cancer prevention in rural tribal communities. Smoke-free policies, including those that target homes, can reduce exposure to secondhand smoke and support smoking cessation. Rural and racial/ethnic inequities intersect to increase tobacco-related harms among Indigenous populations. A smoke-free home program may improve the health of the household as well as impact smoking behavior among the family unit by reducing secondhand smoke exposure.

PRIMARY OBJECTIVE:

I. To assess the effectiveness of a smoke-free homes intervention for tribal communities.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive the smoke-free home program, consisting of mailed educational information about smoke-free homes at enrollment and in weeks 4 and 6, and attend one coaching call in week 2.

GROUP II: Participants receive usual care on study. Participants may optionally receive the smoke-free home program following the 6 months follow-up.

After completion of study intervention, participants are followed up at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* Self-report as being a smoker or living with a smoker
* Indicate that they do not reside in a smoke-free home
* Identify as living in an American Indian household

Exclusion Criteria:

* Children under the age of 18 will not be included
Efficacy and Safety of Transbronchial Bronchoscopic Thermal Vapor Ablation (BTVA) in Heterogeneous Emphysema

Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥40 and ≤75 years old
2. Heterogeneous emphysema
3. 20% predicted value ≤ FEV1 ≤ 50% predicted value, TLC ≥ 100% predicted value, RV ≥ 150% predicted value, DLCO ≥ 20% predicted value
4. 6-minute walking distance (6MWD) \&gt; 140m
5. mMRC index ≥ 2
6. The patients have fully understood the content of the trial and voluntarily signed the informed consent form

Exclusion Criteria:

1. Contraindications to bronchoscopy include: myocardial infarction within the past month, active massive hemoptysis, coagulation dysfunction, pregnancy, malignant arrhythmia, severe pulmonary hypertension, extreme systemic failure, and other conditions
2. Concomitant diseases that may significantly increase the risk of complications after BTVA treatment include, but are not limited to: immune system disorders, bleeding disorders, unstable cardiovascular disease, a history of asthma, and alpha-1 antitrypsin deficiency
3. Concomitant medications known to significantly increase the risk of complications after BTVA treatment include, but are not limited to: immunosuppressive drugs (except topical medications), anticoagulants, and antiplatelet drugs
4. Receiving morphine derivatives within 4 weeks prior to screening
5. Respiratory tract infection or exacerbation of chronic obstructive pulmonary disease (COPD) within 6 weeks prior to screening
6. The upper and lower lobes of the other lung have high-grade emphysematous lesions, defined as HRCT showing that the low-density attenuation area (less than -950 Hu) accounts for more than 40% of the total lung volume.
7. The lobe of the lung where the intended treatment segment is located has large bullae (defined as bullae that occupy more than one-third of the lobe) or paralobular septal emphysema.
8. Symptoms or abnormal laboratory values suggesting active infection (e.g., fever, elevated white blood cell count, etc.).
9. Patients who have undergone or plan to undergo lung or chest surgery during this study, including but not limited to lung resection or lung transplantation.
10. Patients evaluated by specialists to have highly suspected malignant pulmonary nodules.
11. Women who intend to become pregnant, are pregnant, or are breastfeeding during the study.
12. Patients participating in other drug or medical device clinical trials.
13. The investigator believes the patient has other conditions that make them unsuitable for inclusion in this study.
A Trial of SHR-1707 in Healthy Young Adult and Elderly Subjects

A randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707

The study will consist of two parts: Subjects will be randomized to receive SHR-1707 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial,
2. Male or female aged between 18 years and 45 years (inclusive) at the date of signed consent form in Part 1 and aged between 55 years and 80 years (inclusive) in Part 2
3. Total body weight of 45\~100 kg (inclusive), with a body mass index (BMI) of 19\~32 kg/m2 (inclusive) at screening and baseline
4. Subjects with good general health, no clinically significant abnormalities, or have underlying disease which is believed to have minimal impact on the study treatment in elderly subjects
5. WOCBP agree to take effective contraceptive methods

Exclusion Criteria:

1. Severe injuries or surgeries within 6 months before screening
2. ALT, or AST or total bilirubin level \<1.5x upper limit of normal range (ULN) at screening or baseline visits
3. QTcF \> 450msec (Male), QTcF \> 470msec (Female) in 12-lead ECG test during screening and baseline
4. Known history or suspected of being allergic to the study drug.
5. Use of any medicine within 14 days (including any prescription, or over-the-counter medicine, herbal remedy or nutritional supplement, except for vitamins and acetaminophen with recommended dose \[The dose of acetaminophen should be less than 2g/day, and no more than 3 days for continuous use\]), or within 5 half-lives
6. Live (attenuated) vaccination within 1 month before screening
7. Blood donation or loss of more than 400 mL of blood within 3 months; or received blood transfusion within 3 months before screening.
8. History of alcohol abuse in the past 12 months of screening
9. History of illicit or prescription drug abuse or addiction within 12 months of screening
10. More than 5 cigarettes daily for 12 months before screening
11. Participation in clinical trials of other investigational drugs (include placebo) or medical devices within 3 months prior to screening
12. Researchers and relevant staff of the research center or other persons directly involved in the implementation of the program
Prognostic Value Related to the Presence of Thrombosis or Portal Vein Invasion in Patients With Hepatocellular Carcinoma Submitted to Surgery

A retrospective study based on analysis of medical records of patients with hepatocellular carcinoma treated at the Hospital Sírio-Libanês (Sao Paulo-Brazil) between 2001 and 2011 with diagnosis confirmed by imaging or histological specimen underwent surgical resection with curative intent. The study aims to determine the prognostic value of vascular complications related to cancer and to evaluate the survival rate of these patients, comparing the data with those reported in the literature.


Eligibility Criteria:
Inclusion Criteria:

* hepatocellular carcinoma confirmed by imaging or histological specimen underwent surgical resection, with or without hepatic cirrhosis association;
* presence of venous outflow obstruction, either by direct tumor invasion or thrombosis, on portal vein or one of its main vessels;

Exclusion Criteria:

* Patients undergoing prior systemic treatment;
* Patients presenting incomplete data that do not allow their classification according to the stratification models;
* Patients whose information of progression or death can not be recovered;
The Immediate Effect of Defocus Spectacles On the Choroid Thickness Using Optical Coherence Tomography on Children

The purpose is to examine temporary changes in the subfoveal choroid thickness after removal and after resumed use of Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS).


Eligibility Criteria:
Inclusion Criteria:

* Myopic children using Defocus Incorporated Multiple Segment Spectacle Lenses (DIMS) from the ongoing randomized clinical non-inferiority study: "Defocus Spectacle Lenses (DIMS) versus Orthokeratology lenses (OKL) for slowing myopia progression in children" (ClinicalTrials.gov Identifier NCT05134935)
* Myopia at the time of inclusion in the NISDO study: -2.00 to -4.75 D spherical component and up to -2.50 D of regular astigmatism (both eyes)
* Anisometropia \< 1,5 D cycloplegic spherical equivalent refractive error
* Best corrected visual acuity (inclusive): 1.0 Snellen (equivalent to ≥ 3/5 letter on the 1.0 line = 83 ETDRS letters)

Exclusion Criteria:

* Manifest or intermittent squint
* Contraindications to the use of OKL comprising (not exhaustive): keratoconus, chronic allergic conjunctivitis, and keratoconjunctivitis sicca
* Previous eye surgery
* Chronic eye disease demanding daily use of eye drops
* Non-compliance to eye examinations (unstable fixation or anxiety towards contact lenses)
ABT-378/Ritonavir in Combination With Reverse Transcriptase Inhibitors in Antiretroviral Naïve HIV-Infected Subjects

To assess the safety, tolerability and antiviral activity of lopinavir/ritonavir when administered orally in antiretroviral-HIV-1 infected subjects.


Eligibility Criteria:
Inclusion Criteria

* HIV-1 positive
* antiretroviral-adult males
* non-pregnant
* non-lactating females at least 18-years old with plasma HIV-1 RNA \> 5000 copies/mL, who were not acutely ill

Exclusion Criteria

* History of:

  * prior antiretroviral therapy
  * significant drug hypersensitivity
  * psychiatric illness that precludes compliance
  * an active substance abuser
  * positive test results for drug abuse
  * abnormal lab test results (hemoglobin, absolute neutrophil count, platelet count, SGPT/AST or SGPT/ALT, creatinine, fasting triglycerides, significant abnormal ECG results
  * pregnancy or lactating female
  * received another investigational drug within 28 days of study initiation
  * unlikely to comply or unsuitable candidate in the opinion of the investigator
A Prospective Clinical Investigation to Evaluate the Safety and Performance of 877PTY Toric IOL for Visual Correction of Corneal Astigmatism

Medicontur preloaded hydrophobic monofocal toric intraocular lenses (IOLs) are indicated to improve vision at far distance in adults with or without cataract and correction of pre-existing corneal astigmatism secondarily to removal of the crystalline lens.

The intraocular lens is intended to be surgically implanted into the eye with the purpose of restoring optical function in the aphakic eye to provide an optical system with high predictability of the precalculated dioptric power.

The investigation will be performed as a prospective, non-comparative, single arm study with a single center design. Patients will be enrolled who are assigned to be implanted with the 877PTY IOLs mono- or binocularly between January 2024 - June 2025.

Data from six visits will be collected:

* Visit 1: Screening and Baseline (up to 90 days prior to the surgery)
* Visit 2: IOL implantation (Day 0)
* Visit 3: Day 1 post-operatively (+/- 0 day)
* Visit 4: Day 7 post-operatively (+/- 3 days)
* Visit 5: Month 1 post-operatively (+/- 2 weeks)
* Visit 6: Month 6 post-operatively (+/- 1 month)


Eligibility Criteria:
Inclusion Criteria:

* adult patients (18 years old and older);
* cataract and/or corneal astigmatism diagnosis;
* indication for cataract surgery or refractive lens exchange;
* recommended cylinder correction with toric IOL with cylinder power ≥1.0D;
* clear intraocular media other than cataract;
* signed informed consent form;

Exclusion Criteria:

* irregular astigmatism;
* patients who are not targeted to emmetropia (predicted residual spherical equivalent and/or astigmatism is out of the range of ±0.5D and ±0.38D respectively);
* any retinopathy or maculopathy that affects the vision;
* iris neovascularization;
* congenital eye abnormality affecting visual performance;
* advanced glaucoma;
* pseudoexfoliation syndrome affecting IOL stability;
* amblyopia;
* uveitis;
* retinal detachment;
* prior ocular surgery in personal medical history;
* irregular corneal curvature or corneal diseases affecting visual performance;
* high myopia (axial length ≥ 26,5 mm);
* inadequate visualization of the fundus on preoperative examination;
* dilated pupil size not large enough to visualize toric IOL axis markings postoperatively based on the Investigator's decision;
* eye trauma in medical history;
* instability of keratometry or biometry measurements;
* prior corneal refractive surgery such as LASIK, PRK, or SMILE;
* patients deemed ineligible by the investigator because of any systemic disease or treatment;
* pregnancy or lactation;
* current use of systemic steroids or external ophthalmic drugs;
* concurrent participation in another drug or device investigation.

Intraoperative exclusions: the presence of the following intraoperative exclusion criteria will lead to the exclusion of the subject:

- Any unexpected or serious intraoperative complication that makes IOL implantation impossible or results in implantation of another type of IOL that is outside the scope of this clinical trial.
Children's Hospital Academic Medical Organization (CHAMO) MyChart Study

Evolving technology and clinical innovation have led to dramatic changes in the management of type 1 diabetes (T1D). These changes have led to a need to collect a growing number of details from families during their visits. As a result, much of the physician-patient visit is spent transferring information instead of focusing on diabetes care, contributing to increased time pressures in clinic and unmet needs for patients.

In response to this reality, the investigators have developed a tool that allows families to input their diabetes-related information into their physicians' electronic health record (EHR) documentation tool before their clinic visit, using a questionnaire administered via CHEO's secure patient portal (MyChart®). The investigators will evaluate the impact of an integrated electronic patient questionnaire, on quality of care (patient-reported), diabetes control and clinic efficiency. The investigators hope that our study will determine whether having families input clinical data prior to a visit is an effective strategy to improve the quality of diabetes care. The investigators believe that the findings will be of interest to all those studying the value of incorporating patient-entered data both within diabetes care and beyond.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T1D
* Age \<11 years at enrollment

Exclusion Criteria:

* Patients ≥ 11 years of age at enrollment
* Patients who are not fluent enough in English to complete all study related procedures
* Patients unable or unwilling to provide consent and/or assent
* Patients followed in Eating Disorder Clinic or Child and Youth Protection Clinic (there are MyChart activation restrictions for individuals followed in these clinics)