cyrilzakka/clinical-trials huggingface dataset:
Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting

The primary objective of this study is to assess the effectiveness of Tafluprost / Timolol in controlling ocular hypertension, as measured by mean change in intra-ocular pressure (IOP) from baseline to after 6 months of treatment from initiation, in patients with open angle glaucoma (OAG) or ocular hypertension (OHT), who do not respond sufficiently to initial topical treatment, in routine clinical practice.

The primary objective of this study is to assess the effectiveness of Tafluprost / Timolol in controlling ocular hypertension, as measured by mean change in intra-ocular pressure (IOP) from baseline to after 6 months of treatment from initiation, in patients with open angle glaucoma (OAG) or ocular hypertension (OHT), who do not respond sufficiently to initial topical treatment, in routine clinical practice.

This study will include adults with open angle glaucoma or ocular hypertension, who received their first Tafluprost / Timolol prescription at baseline, even if Tafluprost / Timolol was not continued after the first prescription. In addition, patients must have their IOP recorded within 7 days before their first prescription of Tafluprost / Timolol, in order to be eligible for this study. Only those who provide informed consent will be included.

At the time of a scheduled clinic visit, eligible patients will be invited to participate in the study and willing patients will be requested to sign an informed consent form. Once informed consent is obtained, the patient is included in the study and relevant data will be recorded during routine clinical visits. Participation in this study is entirely voluntary; any patient may withdraw consent to participate in this study at any time. The withdrawn patient's data will not be analyzed in this study and the number of patients who withdrew consent will appear in the final study report.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to extraction of data according to the protocol)
* According to the approved indications of Tafluprost / Timolol as indicated in the SPC

  * Male or female patients ≥20 years of age at time of informed consent
  * Diagnosis of open angle glaucoma or ocular hypertension
  * Insufficient IOP control with a monotherapy utilizing topical prostaglandin analogues, necessitating the use of a combination therapy according to the judgement of the treating ophthalmologist
  * Patient judged by their physician to benefit from preservative free eye drops
* Not used Tafluprost / Timolol before

Exclusion Criteria:

* Patient pregnant or nursing
* Pregnancy planned in the following 6 months
* Presence of contraindications as listed in the SPC
* Any ophthalmologic surgery within 6 months prior to the study
* Participation in any other investigational study within 30 days prior to enrolment
Extension Study for 2993-112

This multicenter, open-label extension study of Protocol 2993-112 is designed to assess long-term glucose control as measured by HbA1c (glycosylated hemoglobin) and to evaluate long-term safety and tolerability in subjects treated with metformin who receive subcutaneously injected AC2993 (10 mcg) administered twice daily. Subjects completing Protocol 2993-112 are eligible to enroll.


Eligibility Criteria:
All of the following criteria are to be fulfilled for inclusion of an individual in the study unless the sponsor grants an exception:

* Has completed the 30-week triple-blind treatment initiation/active treatment periods in Protocol 2993-112, including all procedures required at the study termination visit (Week 30).
* Male or female. Female individuals must be either 1) postmenopausal as documented by serum FSH measurement unless using estrogen for hormone replacement therapy; or 2) of childbearing potential and used appropriate contraceptive methods (surgical sterility or oral, injected, barrier, intrauterine, or implanted contraceptives) for the duration of Protocol 2993-112. This individual must have a current, negative pregnancy test (human chorionic gonadotropin \[HCG\], beta subunit) regardless of birth control method used. The individual agrees to continue using birth control throughout the study to prevent pregnancy.
* Able to understand and sign a Protocol 2993-112E-specific informed consent form, communicate with the investigator, and understand and comply with the protocol requirements.

Individuals meeting any of the following criteria are to be excluded from the study unless the sponsor grants an exception:

* Has not completed Protocol 2993-112.
* Female individuals who are pregnant, lactating, or planning to become pregnant.
Study of EN-374 Gene Therapy in Participants with X-Linked Chronic Granulomatous Disease

The goal of this clinical trial is to evaluate the safety and potential efficacy of the EN-374 treatment regimen and identify a dose level for further evaluation in participants with x-linked chronic granulomatous disease.

The main questions it aims to answer are:

* safety of the EN-374 treatment regimen
* effect of the EN-374 treatment regimen on the production of functional neutrophils with NADPH oxidase activity

Chronic granulomatous disease (CGD) is a rare primary immune deficiency disorder characterized by recurrent bacterial or fungal infections starting in infancy. The x-linked form of CGD (X-CGD) is caused by mutations in the CYBB gene.

EN-374 is a helper-dependent adenoviral (HDAd)-based gene therapy in development for the treatment of X-CGD using an in vivo approach, which is administered by IV infusion, to genetically modify hematopoietic stem cells (HSCs) to express a wild-type CYBB gene. The EN-374 treatment regimen includes HSC mobilization, immune prophylaxis, EN-374 administration, and enrichment of genetically modified HSCs.

Adult participants with X-CGD will be enrolled into the dose-escalation part of the study. Following completion of the adult cohorts, then pediatric participants will be enrolled into the dose-expansion part of the study in decreasing age cohorts from ≥ 12 and \< 18 years of age, to ≥ 2 and \< 12 years of age, and finally to ≥ 3 months and \< 2 years of age.

Eligibility Criteria:
Inclusion Criteria:

* Male
* ≥ 18 years of age during dose escalation, then ≥ 3 months of age during dose expansion
* Diagnosis of X-CGD with DHR+ cells ≤ 5% and a pathogenic mutation in the CYBB gene
* History of at least 1 severe infection requiring medical intervention or chronic inflammatory disorder
* Does not have a suitable, available, and willing human leukocyte antigens (HLA)-matched (10/10) related donor
* Non-sterile male participants who are or may become sexually active with female partners of childbearing potential are required to use highly effective contraception
* Informed consent, with informed assent from capable participants
* An anti-EN-374 capsid antibody titer below an established threshold (ie, negative)
* Adequate organ function

Exclusion Criteria:

* Active bacteremia or fungemia
* History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
* History or clinical evidence of any medical or social issues likely to put the participant at additional risk or to interfere with study conduct
* History of HSCT or granulocyte transfusions
* Known hypersensitivity to elements in the treatment regimen
* Undergone investigational gene therapy
* Treated with another investigational drug product within 30 days before screening
* Unable to comply with the visits and requirements of the protocol as determined by the Investigator
Video-Based Functional Performance and Assessment Following Stroke

For hemiplegic, stroke patients wheelchair transfers is a critical, safety-related area of physical function.

This project will develop a personalized training and clinical assessment instrument based on the Video-Based F-PAT (Functional Performance Assessment and Training.) The objectives of the study are: (1) Enhance the pilot F-PAT web site to allow clinicians password-protected access to the digitized video and assessment information; and (2) train an Occupational Therapist collaborator to create the personalized videotapes for patients to take home with them. This study has the dual goal of evaluating the effectiveness of the personalized training videotapes and the effectiveness of the video-based assessment methodology.

For people who have become hemiplegic as a result of a stroke, a critical safety-related retraining area for physical functions is wheelchair transfers. In addition, to incorporate the relatively unsupervised home care into the rehabilitation process, clinicians require a better means to assess functional gains and provide effective training tools. Our goal is to develop a personalized training and clinical assessment instrument based on the Video-Based F-PAT (Functional Performance Assessment and Training) which relies on the manipulation of digitized videoclips. Our development objectives are (1) to enhance the pilot F-PAT web site to allow clinicians password-protected access to the digitized video and assessment information; and (2) to train an Occupational Therapist collaborator to create the personalized videotapes for patients to take home with them. Our clinical objective is to implement a 2-year evaluation of the F-PAT design concept with 30 subjects, divided in 3 groups, who as patients undergo acute rehabilitation at the VA Comprehensive Rehabilitation Center and are discharged to their homes or a sub-acute facility. This study has the dual goal of evaluating the effectiveness of the personalized training videotapes and the effectiveness of the video-based assessment methodology.

The study will divide the subjects into three treatment groups to compare the effectiveness of accepted practice, generic videotape, and personalized videotape home-based instruction for clients and care providers. Comparison of outcomes will be done using videotape of task performance before release from the acute therapy program and at the follow-up evaluation one month later. The subjects will be evaluated by a blinded physiatrist viewing and rating digitized videoclips of task performance on the F-PAT web site. This study will determine if personalized videoclip-based instructional material is effective, and if videoclip comparisons by a clinician is an effective diagnosis and assessment instrument. If it is not possible for logistical reasons for a subject to return to the clinic for the follow-on evaluation, the F-PAT team will visit the subject's home and perform the videotaping on-site. The remainder of the evaluation with input from the physiatrist will occur subsequently at the clinic.

Eligibility Criteria:
Hemiplegic patients
Serial FES PET/CT to Measure Hormone Expression in Patients Undergoing Endocrine Targeted Therapy

This clinical trial studies use of F-18 16 alpha-fluoroestradiol (\[F-18\] FES) positron emission tomography (PET)/computed tomography (CT) in measuring tumor hormone receptor expression in patients undergoing endocrine-targeted therapy for newly diagnosed breast cancer or breast cancer that has come back or spread to other places in the body. Comparing results of diagnostic procedures done before, during, and after hormone therapy may help measure a patient's response to treatment.

OUTLINE:

Patients undergo F-18 FES PET/CT scan at baseline. Patients also undergo F-18 FES PET/CT and FDG PET/CT between 1-12 weeks after starting therapy, and then 1-12 weeks after the second FES PET/CT scan. Repeat FDG PET may be omitted in patients on selective estrogen receptor degrader.

After completion of study, patients are followed up for up to 20 years.

Eligibility Criteria:
Inclusion Criteria:

* Adult, non-pregnant patients with biopsy-proven or clinically obvious primary, recurrent or metastatic breast cancer
* Breast cancer from ER+ primary that is seen on other imaging tests. Tumor ER expression must have been confirmed by immunohistocytochemistry of primary tumor or recurrent disease.
* At least one site of disease 1.5 cm or greater is needed to meet the spatial resolution limits of PET imaging.
* Patients must have been off tamoxifen or other estrogen receptor blocking agents for at least 6 weeks and off chemotherapy for 3 weeks for the initial baseline FES.
* Patients must be selected for an endocrine targeted therapy regimen for treatment of their breast cancer by the referring oncologist. Selected treatments may be part of experimental treatment protocols for which the patient would be separately consented.
* Patients must be willing to undergo serial imaging procedures.
* Patients must agree to allow access to clinical records regarding response to treatment and long term follow up.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* An inability to lie still for the tests
* Individuals weighing more than 300 lb. (this is the weight limit of the scanner table)
* Pregnant or lactating. Women of childbearing potential with either a positive or no pregnancy test at baseline are excluded.
* Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication).
* Use of tamoxifen, faslodex, DES or any other ER blocking agent \< 6 weeks or chemotherapy \< 3 weeks prior to imaging scan.
* Uncontrolled diabetes mellitus (fasting glucose \> 200 mg/dL)
* Adult patients who require monitored anesthesia for PET scanning.
Optimizing Third-Generation Video Laryngeal Mask Position: SaCoVLM™ vs. Fiberoptic Bronchoscope

This study aims to compare the effectiveness of SaCoVLM™ in artificial airway ventilation during general anesthesia, focusing on the correlation between native video camera imaging and fiberoptic endoscopy. Primary outcomes include the analysis of imaging correlation, while secondary outcomes assess initial placement success rates, difficulty, blood clot adherence, vital sign changes, and postoperative complications.

In modern medicine, the management of artificial airways is a crucial component of patient care in emergency departments, operating rooms, and intensive care units, where it plays a vital role in providing respiratory ventilation. The laryngeal mask airway (LMA) is a type of supraglottic airway device. Due to its ease of placement and improvements in ventilation seal and overall angle design, it is now widely used in various clinical situations and can even replace some functions of endotracheal intubation.

However, despite the LMA's ease of placement, operators with limited experience often struggle to adjust it to the optimal position, significantly impacting ventilation effectiveness. Traditionally, to confirm the correct placement of the LMA, practitioners rely on both experiential physical examinations and objective data such as capnography waveforms, leak pressure measurements, ultrasound, and fiberoptic endoscopy images.

The SaCoVLM™ video laryngeal mask is a third-generation supraglottic device that integrates an imaging system, allowing for real-time lateral video recording during placement to observe the relative position of the LMA tip with respect to the vocal cords and surrounding structures.

The aim of this study is to compare the use of SaCoVLM™ for artificial airway ventilation during routine surgical general anesthesia, specifically evaluating the placement adjustments using two different imaging perspectives: the native video camera and fiberoptic endoscopy. The primary outcome is the analysis of the correlation between the two types of imaging. Secondary outcomes include the success rate and difficulty of initial placement of the SaCoVLM™, whether visible blood clots adhere to the device upon removal, changes in vital signs before and after placement, and postoperative adverse events.

Eligibility Criteria:
Inclusion Criteria:

* ASA classification I\~III, age 18\~65 y/o, BMI 18\~30kg/m2, elective surgery, surgery duration \< 2 hours, supine position, general anesthesia with laryngeal mask airway insertion

Exclusion Criteria:

* Smoking, betel nuts use, any known anatomical variation or disease of facial or airway structure, anticipated difficult airway, limited mouth opening distance or neck motility, loosening teeth, gastroesophageal reflux history, ongoing upper airway infection or inflammation symptoms
Efficacy of Pilocarpine As a Secretagogue Versus Artificial Tears for the Treatment of Dry Eye

Management approaches for dry eye disease (DED) typically start with low-risk, easily accessible, patient-applied therapies like artificial tears for early-stage disease. As the condition worsens, treatment progresses to more advanced therapies for severe forms of DED. This study aims to compare the effectiveness and safety of pilocarpine as a secretagogue versus artificial tears in the treatment of dry eye disease. Our goal is to provide reliable, high-quality evidence regarding the efficacy of secretagogues, thereby contributing to the development of recommendations that aid clinicians in their decision-making process


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with DED

Exclusion Criteria:

* Previous Occular surgery.
* Refuse to particupate.
* Patients with sjogren syndrome
New Prognostic Predictive Models of Mortality of Decompensated Cirrhotic Patients Waiting for Liver Transplantation

The MELD score is a predictive model of cirrhosis mortality used in France since 2007 to prioritize access to liver transplantation for patients enrolled in the national waiting list. The predictive value of this score was recently revised downward with a C index of the order of 0.65-0.67 and 20% of the patients enrolled for decompensated cirrhosis have access to liver transplantation by a subjective system of "expert component" independent of the MELD because of this lack of precision. The use of the MELD score to individually define access to the transplant should so be reconsidered. Recently new predictive models of cirrhosis mortality better than MELD have been developed and new mortality predictors independent of MELD have been published.

The goal of this study is to design prognostic predictive models of mortality for decompensated cirrhotic patients enrolled on the national liver transplant waiting list including known (MELD, MELD Na) as more recent (CLIF-C AD, CLIF - CACLF) predictive models and new objective predictors studied in combination in order to optimize the system of allocation of hepatic allografts in France.

The expected benefits of this search are twofold:

* At the individual level: The possibility for patients at high risk of death but with intermediate MELD score to be transplanted.
* Public health plan:

  * Improving the equity of graft allocation system.
  * Decreased mortality in the waiting list by improving the fairness and efficiency of the graft allocation system, a major public health issue


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years old) newly registered on national waiting list with main diagnosis "cirrhosis"
* Patients enrolled on the national waiting list under the "national liver score" allocation scheme whether an expert component is considered or not
* Patients (or trusted person or family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent
* Patients affiliated to a health insurance scheme

Exclusion Criteria:

* Patients enrolled with decompensated cirrhosis associated with hepatocellular carcinoma
* Patients on AVK (INR and therefore MELD and CLIF scores uninterpretable)
* Vulnerable population (person under guardianship or curatorship or deprived of liberty by a judicial decision)
* Pregnant and / or breastfeeding woman
Short-Term Prognosis Evaluation of Transient Ischemic Attack Patients Using ABCD2 Score

The purpose of this study is to determine whether the ABCD2 score can be used in patients with transient ischemic attack, admitted to Beijing anzhen hospital, to evaluate the prognosis, risk factor of those patients.

The feasibility of risk stratification of patients with acute transient ischemic attack admitted to Beijing anzhen hospital by the ABCD2 score system is yet to be determined. The aim of this paper was to evaluate and validate the short-term prognosis of TIA patients in Peking area using this new score system.

Eligibility Criteria:
Inclusion Criteria:

* Every patient admitted to Beijing anzhen hospital with transient ischemic attack will be enrolled in this study, from 06/2007 to 12/2008. duration of the symptom not larger than 1 hour.
* Magnetic resonance imaging negative on DWI(no fresh infarction).
* Old infarction or not the criminal infarction.

Exclusion Criteria:

* Patients with hemorrhage stroke were excluded.
Urethral Length and TOT (Transobturator Tape) Positioning

This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure.

This is a prospective, observational, multicenter study of women with surgically-correctable stress urinary incontinence who undergo a TOT-sling operative procedure. Data will be collected from preoperative urogynecological testing and medical histories. Outcome data will be collected 1-3 days and 6 months after procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test.
2. Patient is age 18 or older.
3. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Institutional Review Board (IRB)/Ethic commission (EC)-approved informed consent.
4. Patient is able to fill in all questionnaires (on judgement of investigator)

Exclusion Criteria:

1. Patient has an associated or suspected neurological disease.
2. Patient has an active lesion or present injury to perineum or urethra.
3. Patient has a urethral obstruction.
4. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment.
5. Patient currently has an urinary tract infection.