cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Change to Prevent Diabetes Via African-American Churches

Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of the GLB program compared with a health education intervention.


Eligibility Criteria:
Inclusion Criteria:

* Self-described African American
* BMI ≥25kg/m2
* Planning to remain within the community for 1 year
* Non-diabetic

Exclusion Criteria:

* Fasting plasma glucose ≥ 126 mg/dl following at least an 8-hr fast or A1C≥7.0%
* HIV/AIDS
* Active tuberculosis
* Cancer requiring treatment in past 5 years except for cancers that have been cured or in the opinion of the researchers has a good prognosis
* Stroke within the past 6 months
* Cirrhosis of the liver
* Currently pregnant or planning pregnancy within the study period
* Gastric weight-loss surgery
* Weight loss \> 10% in past three months for any reason other than childbirth
* Anti-diabetic medications
* Prescription weight- loss medications
* Anti-neoplastic agents
* Anti-psychotic agents that have gluco-corticoid effect
* Oral corticosteroid use \>6 weeks
* Unwilling or unable to give informed consent
* Unable to communicate with the church team or research group
* Participation in another research study that would interfere with FBAS
Does Altering Magill Forceps Affect Nasal Intubation Time

The purpose of this study is to see whether altering the angle of the Magill forceps by 45 degrees will affect nasal intubation time in pediatric dental surgery patients.

The null hypothesis is that their will be no difference between the nasal intubation times of those patients intubated with the conventional Magill forceps and those intubated with the altered Magill forceps.

The Magill forceps (MF) is the instrument of choice for nasal tracheal intubation (NTI). It serves as an aid for inserting the endotracheal tube tip past the vocal cords during NTI. NTI is preferred over oral tracheal intubation (ETT) in certain instances such as pediatric dental surgery. This is because NTI permits excellent access to all intraoral structures while reducing risk of inadvertent displacement of an orotracheal tube. Although there is literature looking at MF design alterations to reduce complications and improve its other uses, there is no literature examining the effect of design alterations on time to successful intubate (TTI). Our study premise is based on the concept that a MF is not ideally structured for the pediatric airway anatomy. Knowing that the larynx is considerably anterior in the pediatric airway, we hypothesized that a + 45° angle change 2cm from the tip of the MF will help align the direction the instrument carrying the endotracheal tube with the anatomic direction of the airway and thus help reduce the TTI.. If a reduction in TTI can be shown it would be of significant benefit and could add another tool for NTI. Even though, the current MF has been satisfactory in its use, this should not deter us from looking for opportunities to improve on the current standard. To test this hypothesis, we will include a hundred participants as part of an open label, controlled, single center, and randomized study in which 50 patients will be intubated with the conventional MF and 50 patients will be intubated with the altered MF. We expect the results to show at least a 5 second reduction in TTI and thus be statistically significant with a p value less than 0.05 for our sample size. Our expected conclusion is that a reduced TTI is clinically beneficially as it will reduce apnea time in the pediatric patients, a population with known physiological limitations in respiratory reserve. This, in turn, could point to a reduction in intra-operative and post-operative respiratory complications.

Eligibility Criteria:
Inclusion Criteria:

* age 0-15yrs, ASA \< or = 2, Mallampati \< or = 3, presenting of dental surgery

Exclusion Criteria:

* patients at risk for aspiration, upper airway abnormalities, known difficult airway
Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia

This study is designed to verify the clinical efficacy and safety of different statins in dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired glucose regulation.

Study Objective:

1. The main Objective: To explore the effects of different statins lipid-lowering treatment on glucose metabolism in patients with impaired glucose regulation in a large sample of Chinese population;
2. The secondary Objective: To obtain real-world evidence of the clinical efficacy and safety of statins lipid-lowering therapy in Chinese patients.

Study Design: The study was an open-label, multi-center network register-based follow-up study.

The total sample size: 10000 participants.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a clinical diagnosis of ASCVD (Acute coronary syndrome, Stable coronary heart disease, Postoperative revascularization, Ischemic cardiomyopathy, Ischemic stroke, Transient ischemic attack, Peripheral atherosclerotic disease).
2. ASCVD overall risk assessment for high-risk groups: Diabetic patients with LDL-C≥1.8mmol/L（70mg/dl）and age was equal or greater than 40 years old;
3. Patients with hypertension, LDL-C \> 2.6mmol/L (100mg/dL) and combined with at least two risk factors. Risk factors include smoking, low HDL-C (HDL-C\<1mmol/L, 40mg/dL), male aged over 45 years old or female aged over 55 years old; \*\*\* The above (1)-(3) are juxtapositions, patients can be included into the group if only they are satisfied with at least one of the inclusion criteria.

Exclusion Criteria:

1. Patients with any allergy to statins;
2. ACS patients in acute stage；
3. Patients with severe liver disease or biliary obstruction；
4. Patients taking cyclosporine；
5. Patients who have being treated with statins currently or in the past;
6. Pregnant or lactating women and those women who planning to be pregnant;
7. Immunodeficiency or Immunocompromised patients;
8. Patients with hypothyroidism (expect those patients whose thyroid function returned to normal level after drug therapy);
9. Patients using systemic hormone drug;
10. Researchers decided that the patients who was not suitable to participate in the study.
Performance and Safety of Routine Cataract Surgery With Visiol

In this clinical investigation, the performance and safety of routine cataract surgery with VISIOL will be assessed


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years and older;
* Candidate for cataract surgery via phacoemulsification;
* Ophthalmic surgeon's recommendation to use VISIOL prior to recruitment;
* Eligible for the use of VISIOL as indicated in the instructions for use;
* Written informed consent.

Exclusion Criteria:

* Known allergy or hypersensitivity to any of VISIOL components;
* Known pregnancy or breast feeding;
* Participation in any other clinical research study within the last 90 days;
* Patients with legally restricted autonomy, freedom of decision and action (e.g. those with measure of custody or judicial protection);
* Incapacity to understand the informed consent and/or to comply with the Clinical Investigation Plan (CIP), per investigator's appreciation.
A Study to Evaluate the Efficacy and Safety of GDC-8264 in Preventing Cardiac Surgery-Associated Acute Kidney Injury (AKI) and Major Adverse Kidney Events (MAKE)

The aim of this study is to evaluate the efficacy and safety of GDC-8264 compared with placebo in participants undergoing cardiac surgery who are determined to be at moderate to high risk of developing AKI and subsequent MAKE at 90 days after surgery (MAKE90). The study will be performed in two parts- Part 1 and Part 2.


Eligibility Criteria:
Inclusion Criteria:

1. One of the following non-emergent cardiac surgery types that requires cardiopulmonary bypass (CPB) to be done in one procedure rather than separate procedures: Isolated Coronary Artery Bypass Grafting (CABG); Isolated Surgical Aortic Valve Replacement (AVR), Mitral Valve Replacement (MVR), Mitral Valve repair (MVr); Combined CABG+AVR, CABG+MVR, CABG+MVr, AVR+MVR, AVR+MVr
2. At least one or at least two of the following AKI risk factors, depending on the type of surgery: age \> 70 years, history of CKD with eGFR \< 60 milliliters/ minutes/ 1.73 meter square (ml/min/1.73 m\^2) within the last 6 months, diabetes (type 1 or type 2) requiring at least one oral hypoglycemic agent or insulin, history of chronic obstructive pulmonary disease (COPD) requiring medical therapy, left ventricular ejection fraction (LVEF) \< 40%, preoperative anemia \[hemoglobin \<10 grams/deciliters (g/dL)\]
3. Stable kidney function with no known episodes of AKI within 2 weeks of screening

Exclusion Criteria:

1. Need for renal replacement therapy (peritoneal dialysis or hemodialysis)
2. Need for intra-aortic balloon pump, temporary mechanical circulatory support, or extracorporeal membrane oxygenation prior to scheduled surgery
3. Presence of a durable left ventricular assist device
4. Need for concurrent aortic surgery that requires circulatory arrest and deep hypothermia or repair of congenital heart defects
5. Heart transplant
6. Transcatheter valve replacements
7. Hypotension or shock requiring hospital admission
8. Cardiopulmonary resuscitation
9. eGFR \< 20 mL/min/1.73 m\^2
10. Heart failure with ejection fraction \< 20%, or episode of decompensated heart failure requiring intervention within 2 weeks prior to screening
11. History of kidney transplant or only one kidney (due to donation)
12. Renal agenesis, total nephrectomy, or partial nephrectomy of \> 50%
Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Study

The purpose of this long-term safety study is to follow up subjects treated with CTX0E03 DP to monitor for delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival

The goal of this study is to assess the long-term safety of subjects treated with intracerebral CTX0E03 DP as measured by the onset of delayed adverse events of special interest (AESIs). AESIs are defined as adverse events leading to death, new oncological adverse events, new neurological adverse events and any other adverse event, which in the opinion of the Safety/Project Physician is related to CTX0E03 DP.

Eligibility Criteria:
Inclusion Criteria:

Subjects who have received CTX0E03 DP as part of the active arm in the PISCES III study Have provided appropriate written informed consent

Exclusion Criteria:

* None
Progress at Work - The Impact of Adalimumab on Work Related Productivity in Patients With Rheumatoid Arthritis

The purpose of this study is to describe the impact of treatment with adalimumab on work related productivity and economic burden in patients with Rheumatoid Arthritis (RA) treated in Canada.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects with moderate to severe RA for whom the physician has decided to initiate treatment with adalimumab
2. Adult male or female ≥ 18 years old that has been newly prescribed adalimumab therapy according to the local product label and are with PROGRESS
3. Subjects should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB
4. Subject is able to give written patient authorization and is willing to comply with the requirements of this study protocol.

Exclusion Criteria:

1. Subject cannot or will not sign a patient authorization
2. Subject with a known hypersensitivity to Adalimumab, or any of its components
3. Presence of any condition that, in the opinion of the treating physician, prohibits the subject from participating in the study or obscures the assessment of the treatment of RA
4. Subjects currently participating in an investigational clinical trial
5. Subjects treated with \>1 prior biologic disease-modifying antirheumatic drugs (DMARDs) for RA. Any prior treatment with adalimumab is prohibited
6. Subjects previously treated with targeted synthetic disease modifying agent.
Basal Like Bladder Cancer : Signature and Therapeutic

Muscle invasive (MIBC) and/or metastatic bladder cancer is associated with poor prognosis and no target therapies for this pathology are currently validated. By 40 gene expression signature realized on frozen samples, we have previously identified an aggressive sub-class of MIBC, called basal. This sub-class (20% of MIBC) showed strong EGFR dependence in vitro and in vivo (Rebouissou et al. Science Translational Medicine 2014). This observation suggests a possible response to EGFR targeted therapy in patients of this subgroup. Our aim is to establish a standard diagnostic tool to differentiate the basal subtype of bladder cancer and evaluate the effect of anti-EGFR therapy, by analyzing previous clinical trial (GETUG19) and preclinical models, which compare the classical chemotherapy to anti-EGFR associated chemotherapy.

The aim of this study is:

1. To validate a diagnostic test for formalin-fixed paraffin-embedded (FFPE) samples by Nanostring technology, using the 40 genes signature as reference. First, we will compare frozen and FFPE tissues (n=120), to establish a transcriptional signature in FFPE samples. Secondly, to further characterize basal subtype of bladder cancer, we will study the mutational and gain/loss landscape and immunohistochemistry markers in a new series of tumors after classifying them by our gene signature (n=510). These characteristics will be included in a new signature by defining the optimal prediction discrimination AIC et Net Reclassification Index.
2. To assess the prognosis after cisplatine treatment in 510 patients treated by cystectomy with or without adjuvant chemotherapy (pT2/pT3/pT4, N0 or N+) and in another multicentric series of 188 patients treated by cystectomy and adjuvant chemotherapy (pT3/pT4 et/ou N+). Uni and multi variant analysis will be realized by adjusted Cox model, and the added value of basal subtype as compared to standard prognostic factors will be evaluated. The propensity score will be realized to assess the association of basal subtype and response to chemotherapy. The anti-EGFR response will be analyzed in the clinical trial GETUG19 which uses Panitumumab in patients with metastatic urothelial carcinomas (n=93)
3. To study the treatment response in preclinical models. We characterized previously preclinical murine models derived from xenografts of MIBC (n=14 and new xenografts will be added). We will study the effect of anti-EGFR alone or in combination with chemotherapy in basal and non basal subtypes of xenografts.

By this study we will be able to better characterize the basal subtype of bladder cancer and confirm its aggressive behaviour as compared to other subtypes of MIBC. These results will further help to establish new clinical trials which include anti-EGFR in patients of basal subtype.

Eligibility Criteria:
Inclusion Criteria:

Muscle invasive bladder cancer Treatment by cystectomy Adjuvant chemotherapy for 3rd cohort Clinical trial GETUG 19 for 4th cohort

Exclusion Criteria:

FFPE material not available Follow-up data not available
Radiomics of Intra-abdominal and Subcutaneous Adipose Tissue Predict the Efficacy of Bariatric Surgery (RISABS)

Using radiomics of intra-abdominal and subcutaneous adipose tissue and clinical features to predict the weight loss efficacy and remission of type 2 diabetes mellitus after bariatric surgery.

In this study, the investigator intend to collect abdominal CT from patients who are proposed to undergo bariatric surgery, to extract the radiomics of intra-abdominal fat and subcutaneous fat, and to establish a prediction model for predicting the efficacy of weight loss and remission of type 2 diabetes mellitus at 1 year, 3 years, and 5 years postoperatively, in conjunction with the clinical data.

Eligibility Criteria:
Inclusion Criteria:

* BMI\>27.5kg/m2; Type 2 diabetes mellitus; Patients who will undergo bariatric surgery

Exclusion Criteria:

* Patients without abdominal CT scan; Patients did not undergo sleeve gastrectomy or Roux-en-Y gastric bypass.
Study of VVN001 Ophthalmic Solution in Dry Eye Disease

This is a Phase 2a, multi-center, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the safety and tolerability and to explore the efficacy activity of VVN001 ophthalmic solution versus vehicle in subjects with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent prior to any study-related procedures .
* Are 18 years of age or older.
* Are willing and able to follow instructions and willing to be present for the required study visits for the duration of the study.
* Have a best corrected visual acuity (BCVA), using corrective lenses if necessary, in the qualifying eye(s) of +0.7 or better as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) at the screening visit and randomization visit.
* Have a history of dry eye disease in both eyes
* Are currently using artificial tears and have been using within 30 days of the screening visit.
* Have an Eye dryness score ≥40 at Visit 1 and ≥35 at Visit 2, one score for both eyes (0-100 point VAS)
* Have ongoing dry eye disease in the same eye or both eyes, as defined by all of the following criteria in the study eye and the same eye at Visit 1 and Visit 2:
* Inferior CFS (iCFS) score of ≥2 (NEI; 0-4 scale; using 0.5 unit increments)
* Have a Schirmer score (without anesthesia) of ≥1 and ≤7 mm/5 min.

Exclusion Criteria:

* Have a known hypersensitivity or contraindication to the IP or components of IP.
* Have a Schirmer score (without anesthesia) of \<1 or \>7 mm/5 min in the study eye.
* Have history of uncontrolled glaucoma, IOP over 21 mmHg in either eye at the screening visit or are being treated with eye drops for glaucoma in the study eye. Or the subject has had laser or surgery for glaucoma in the study eye within 90 days of the study.
Comparison of Caudal Block and Erector Spinae Block for Postoperative Analgesia

Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients.

Circumcision and any lower abdominal surgery in the pediatric population result in a very painful postoperative period, even when each procedure is evaluated separately. Caudal block (CB), a regional anesthesia technique, is the most commonly used neuraxial block method for postoperative pain control in sub-umbilical surgeries in children. However, peripheral nerve blocks have been reported to be preferred in recent years in the literature since they provide longer and safer analgesia. One of these blocks, the erector spina plane (ESP) block, has been shown to provide effective postoperative analgesia when administered from the lumbar level for sacral and lower abdominal surgeries and urogenital surgeries in pediatric patients. As far as we know, there is no previous study in the literature comparing CB and ESP block in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* 1-7 years of age
* ASA (American Society of Anesthesiologists) I-II group
* Scheduled for circumcision and unilateral lower abdominal surgery at the same session
* Able to communicate in Turkish
* Willing to participate to the study (parents and children)

Exclusion Criteria:

* Less than 1 or more than 7 years of age
* A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital lumbar anomaly, liver and/or kidney disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
* Unwilling to to participate to the study ((parents or children)
Effects of a 3D-Printed Port-A Catheter Model Training Course

The aim of this study is to develop a highly realistic 3D-printed Port-A catheter upper body model to improve the knowledge and self-care skills of patients and primary caregivers regarding Port-A catheter placement through patient education.

Background： Cancer patients often require long-term administration of chemotherapy drugs, nutritional supplementation, and blood transfusions. During these treatments, an implantable central venous access (port-a catheter) is often utilized to avoid the inconvenience of repeated needle insertions for treatment and to minimize the risk of medication leakage. Port-A catheters are considered a safer clinical measure. However, poor care and maintenance of the catheter can lead to complications such as infection, catheter damage, and leakage, which can even result in death. The study aims to assess the impact of patient discharge education on their knowledge and satisfaction regarding catheter care.

Methods： This study focuses on patient education and evaluating its effectiveness. It employs a prospective randomized controlled trial with a cross-sectional design and parallel groups. The participants are divided into the 3D model group (experimental group) and the conventional education group (control group). A total of 120 subjects from the hematology-oncology ward are included in the study. The participants are randomly assigned to either the experimental group (60 participants) or the control group (60 participants) based on the month of admission, following a cluster randomization approach.

Effect： The investigator anticipate that the use of a 3D-printed upper body Port-A catheter model will yield better results in patient discharge education.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the hematology and oncology ward of Fu Jen Catholic University Hospital
* Have Chinese communication skills

Exclusion Criteria:

* Refused to participate in the study.
Evaluation of Remote Monitoring of Liver Cirrhosis Patients

The goal of this longitudinal prospective study is to investigate disease course in patients with liver cirrhosis treated in hospitals that implemented a remote monitoring care pathway as part of their standard liver cirrhosis care pathway.

Participants will be asked to share their medical data and remote monitoring data. Therefore, this study does not contain an intervention.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis diagnosis, based on liver biopsy, fibroscan (elastography), radiographic imaging and/or clinical criteria according to applied guidelines at the time of inclusion
* Age 18 years or older
* Treated at Gastroenterology department

Exclusion Criteria:

* Patients who have declined participation in scientific studies.