cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Conjunctivochalasis

A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis

Phase 2a, randomized, placebo-controlled, pilot study in up to 21 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 2:1 (active:placebo) ratio to one of two treatment groups, LO2A or placebo.

This study with 4 visits, will consist of a screening period of up to 2 weeks and a 3-month treatment period (topical, OU, QID application of eye drops).

Eligibility Criteria:
Inclusion Criteria:

1. Male or female of any race and ≥ 18 years of age.
2. Willing and able to provide voluntary written informed consent.
3. Moderate to severe conjunctivochalasis defined by:

   * LIPCOF score ≥ 2; and
   * Lissamine green conjunctival staining score ≥ 5 according to National Eye Institute/Industry Workshop report.
4. Willing and able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

1. Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:

   * Subject has been diagnosed or treated for another malignancy within 3 years of screening, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy.
   * A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications.
2. Subjects with pterygium.
3. Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
4. Subjects with blepharitis requiring treatment.
5. Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
6. Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial.
7. Subjects who have used any of the following medications or treatments:

   * LASIK or PRK surgery within 12 months of Visit 1.
   * Use of contact lenses within 7 days of Visit 1.
   * Punctal plug insertion within 30 days of Visit 1.
   * Use of topical or systemic cyclosporine within 30 days of Visit 1.
   * Use of medications known to cause ocular drying (e.g. antihistamines, sleep aids, etc.), unless at a stable dose, within 30 days of Visit 1.
8. Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981).
9. Active abuse of alcohol or drugs.
10. Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
11. Participation in a clinical trial of an investigational (unapproved) drug or device within 1 month prior to screening or scheduled to receive another investigational drug or device during this study.
Korea Surgical Quality Improvement Program

The member of National Evidence-based Healthcare Collaborating Agency and the planning committee of Korean Association of hepato-biliary pancreatic Surgery established the protocol of Korean Surgical Quality Improvement Program (KSQIP) with verifying variables of American College of Surgeons - National Surgical Quality Improvement Program (ACS-NSQIP and National Clinical Database (NCD) of Japan; demographics, preoperative information, laboratory values, operation finding, general occurrences, postoperative occurrences, and follow-up data to develop post cholecystectomy complication risk model.

The 50 surgeons from 20 hospitals have decided to participated in the primary prospective study to apply KSQIP to cholecystectomy. The investigators developed web-based database system (http://www.ksqip.org/gb) and surgical clinical reviewer of each hospital will fill out the case report form. Finally, the investigators will provide a risk-adjusted surgical risk calculator and feedback system for reducing complication.


Eligibility Criteria:
Inclusion Criteria:

* Patient who underwent cholecystectomy with cholecystitis or gallbladder polyp or cholelithiasis

Exclusion Criteria:

* Under 18 age
* Who underwent other abdominal surgery simultaneously
* Gallbladder Cancer, cholangiocarcinoma
* Who did not agree with participation
Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis

The research aim to find out whether berberine can reduce the annual recurrence rate of ulcerative colitis in remission.

A total of 238 patients with ulcerative colitis in remission will be randomly divided into two groups.One will receive regular treatment,and the other group will receive extra oral berberine 300 mg three times daily for a year.

The end of the study for every patient is disease recurrence(Mayo Clinic score of 3 points or more ).

The primary analysis is annual recurrence rate, and both endoscopy and Mayo Clinic disease activity index scores at the baseline and final assessments.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis with ulcerative colitis(according to the second European evidence-based consensus on the diagnosis and management of ulcerative colitis);
2. Disease remission of ulcerative colitis(a total Mayo Clinic score of 2 points or less and an endoscopic score of 1 point or less);
3. Diagnosis of moderate or severe ulcerative colitis within 3 months(a total Mayo Clinic score of 6-12 points)

Exclusion Criteria:

1. Prior bowel resection surgery;
2. Women who are planning or actual pregnancy or lactation during study period;
3. Patients allergic to berberine;
4. History of disease that would interfere with their participation in the trial, including malignant diseases, bleeding disorders, active gastric or active duodenal ulcers, autoimmune diseases, and mental or emotional disorder;
5. Take the following treatment:

   * Unstable dose of 5-ASA drugs (oral and/or rectal route) within 14 days prior to screening;
   * Unstable dose of any immunomodulating/suppressive agents and any Anti-TNF therapy within 3 months prior to screening;
   * Traditional Chinese Medicine for the treatment of UC (any pharmaceutical form) within 7 days prior to screening.
A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer

The purpose of this study is to evaluate pharmacokinetics (PK) following a single dose and multiple dose treatment and the safety of apalutamide in Chinese participants with metastatic castration resistant prostate cancer (mCRPC) at dose of 240 milligram (mg).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2
* Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
* Metastatic disease as documented by bone scan or metastatic lesions by computed tomography or magnetic resonance imaging scans (visceral or lymph node disease). Lymph nodes in the pelvis must measure at least 1.5 centimeter in a short axis to be considered target lesion according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 based on the Prostate Cancer Working Group 2 (PCWG2) criteria
* Castration-resistant prostate cancer (PC) demonstrated during continuous androgen deprivation therapy (ADT), defined as 3 rises of prostate-specific antigen (PSA), at least 1 week apart, with the last PSA greater than or equal to (\>=) 2 nanogram per milliliter (ng/mL)
* Prior hormonal interventions (including 1st generation antiandrogens \[flutamide, bicalutamide, nilutamide\], steroids, estrogens, finasteride, dutasteride) for PC are allowed. These therapies, except for gonadotropin releasing hormone analogs (GnRH) analogs and prednisone/prednisolone, must have been discontinued for minimally 4 weeks (2 weeks only for flutamide, nilutamide, or finasteride) before first dose of study drug

Exclusion Criteria:

* Known brain metastases
* Chemotherapy, or immunotherapy within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks.
* Prior treatment with second-generation anti-androgens (example \[eg\], enzalutamide)
* Administration of an investigational therapeutic within 2 weeks or 5 half-lives of the drug prior to the first dose of study drug, whichever is longer, with a maximum of 4 weeks. And participant use radiopharmaceutical agents (eg, strontium-89) or investigational immunotherapy (eg, sipuleucel-T) within 12 weeks prior to the first dose of study drug
* Prior treatment with cytochrome 17 inhibitors (eg, abiraterone acetate, orteronel, galeterone, systemic ketoconazole)
Concentrated Platelet Rich Fibrin (C-PRF) as Adjunct to Non-surgical Periodontal Therapy

The current study is a prospective randomised split mouth study to evaluate the effect of concentrated Platelet Rich Fibrin as an adjunct to the scaling and root planing

Twelve healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.

All the patients underwent scaling and root planing. As it is split mouth study design the test site is treated with Concentrated platelet rich fibrin( C-PRF) and the contralateral site is not treated with C-PRF. Periodotal pack was placed and patient was recalled after 6 weeks for the follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Patient age ranging from 18-45 years
2. Contralateral sites with probing depth 5mm-7mm associated with premolar and molar teeth with no furcation involvement
3. No systemic disease
4. Not under any medication which effect the outcome of periodontal therapy

Exclusion Criteria:

1. History of any periodontal therapy within past 6 months
2. Pregnant and lactating mothers
3. Smokers smoking \>10 cigarettes per day
4. Patients with blood disorders or platelet count less than 50000 cells/ µL
5. Patients with known systemic disease
6. Non-compliant patients
Single-shot Versus Slow Infusion Interscalene Block and Its Impact on Diaphragmatic Function in Patients Undergoing Shoulder Surgery.

Interscalene brachial plexus block is a commonly chosen anesthetic technique for shoulder and proximal arm surgery yet it carry several risks including phrenic nerve block.

Researchers assumed that slow administration of local anesthetic would reduce incidence of phrenic nerve block

patients will be randomly allocated into one of 2 groups ( single shot group) and slow administration group . single shot will receive a 10 ml bolus of 0.5% bupivacaine the other group will receive 10 ml 0.5 % bupivacaine over 10 minutes (at a rate of 1ml/minute) using syringe pump An experienced operator who will be blinded to method of administration will conducted diaphragmatic excursion of ipsilateral hemidiaphragm using curved probe at baseline and at 10 minutes interval for 30 minutes Complete phrenic will be defined as 75% or more reduction in DE, while partial failure as 25%-50% reduction in DE

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II undergoing shoulder surgery under GA

Exclusion Criteria:

-
Essential Oils and Post COVID-19 Fatigue

The purpose of this study is to assess the efficacy of plant based aromas on energy levels among otherwise healthy female survivors of COVID-19.

After being informed about the study, participants will provide informed consent, then will be randomized into one of two groups in a 1:1 ratio. Participants will either inhale an inert blend twice a day or an active aroma twice a day for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-49
* Lives in the United States
* Otherwise Healthy
* COVID-19 Diagnosis between December 1, 2020 and March 31, 2021
* Decreased energy or fatigue at a level that was not present prior to the diagnosis

Exclusion Criteria:

* Positive COVID-19 test any time before December 1, 2020
* Positive COVID-19 test any time after March 31, 2021
* COVID vaccine of any type scheduled during the intervention period or the week prior to the start of the study
* Allergy to any of the ingredients
* Pregnant, trying to conceive, or breastfeeding
* Regular smokers in the home
* Abnormal pulmonary function
* Chest pain
* Recurring headaches
* Uncontrolled hypertension
* Chronic Fatigue Syndrome diagnosis
* Persistent fatigue prior to COVID-19 diagnosis
* Hypothyroidism
Exploring Water-free Sodium Storage

The overarching goal of this proposal is to definitively establish if acute water free Na storage and release occurs, if the amount stored/released is of a quantity that is physiologically relevant, and if the location is intracellular vs. extracellular.

This study is designed as a an ultra-rigorous inpatient balance study. The main purpose of the study is to determine if significant mobilizable non- extracellular volume (ECV) Na storage occurs in humans. This is a randomized, blinded crossover study. Patients will be randomized to Na free 5% dextrose solution or 1.5% standard peritoneal dialysis (PD) fluid (Dianeal 1.5% low calcium PD solution with standard 132 mmol/L Na and osmolarity of 344 mOsmol/L) and will receive treatment for 5 days, following a 6 week wash out patient will return to undergo 5 days of alternate therapy.

Eligibility Criteria:
Inclusion Criteria:

* ESRD Patients actively undergoing PD with a reliably functioning PD catheter
* Systolic blood pressure \> 130 mmHg
* Serum sodium \>135 mmol/L
* daily urine output \< 400ml
* stable PD prescription for at least 2 months without requirement of 4.25% glucose PD solution
* PD vintage of at least 6 months
* Euvolemic as defined by the patient at their dry weight and free of any signs or symptoms of volume overload, per referring nephrologist

Exclusion Criteria:

* Poorly controlled diabetes with hemoglobin A1C\>9%
* 1 or more episodes of peritonitis in the previous 6 months or active infection of the peritoneal dialysis catheter
* Anemia with hemoglobin \<8g/dL
* Inability to give written informed consent or follow study protocol.
* Urinary incontinence
* Body weight \< 60kg
* gastrointestinal disease that causes diarrhea or expectation of sodium losses in stool.
* use of amiodarone in the last 6 months (which will interfere with tissue iodine ascertainment).
Safety Profile of Secotex ® in Patients With Benign Prostatic Hyperplasia

The Objective of this study is to conduct a Prescription Event Monitoring (PEM) involving patients treated with Secotex® (Tamsulosin) in "real life" settings. The aim of a PEM is to monitor the safety profile of Secotex® in a cohort of patients with Benign Prostatic Hyperplasia as used in general practice


Eligibility Criteria:
Inclusion Criteria:

* Patients of any age with a diagnosis of symptomatic Benign Prostatic Hyperplasia (BPH) and/or that, according to the Physician, their symptoms require medical treatment to improve their quality of life. The patients could be naïve to treatment or could be on treatment with other drugs but have not responded adequately to treatment. This study is non-interventional, so the decision to treat must be based on the best standard accepted clinical practice, and according to Secotex® prescribing information

Exclusion Criteria:

* Patients with known hypersensitivity to Tamsulosin, or any other component of the product
* Patients with a history of orthostatic hypotension or severe liver failure
Stocking of a Busy Emergency Department

Stocking of essential supplies in an emergency department (ED) is crucial in order to efficiently and effectively take care of patients. When equipment and supplies are not available to patient care providers, an imbalance in the delivery of care is created. The amount of time nurses spend away from the bedside obtaining supplies has only been superficially studied; however, one study proposed that the majority of nurses spend 5 to 20 percent or more of their time during a shift. This results in 30 minutes to two-and-a-half hours of a twelve hour shift being lost to retrieving supplies that are not available.

Cabinets and drawers have recently been eliminated in the rooms and stock is kept in "supply towers" that contain all the necessary supplies to adequately take care of patients with the exception of medications, or stationary supplies. Towers are restocked every morning by a stocking technician by taking the towers to the stock room, resupplying them based on previously established PAR levels, and utilizing a standard chart that describes exactly what supply, and how many to stock within a specified area of the cart.

During their shift, the stocking technician must also respond to pages concerning low stock levels.

Hypothesis:

Nurses spend a significant amount of time away from the patient bedside during their shift looking for supplies.

Objectives:

* Determine the amount of time nurses spend outside of a patient room obtaining supplies to care for the patient.
* Determine what supplies are obtained when the room is left.
* Determine how many times per shift the nurse leaves to obtain the same item.
* Determine if utilizing a "supply tower" located in patient rooms decreases the amount of time nurses spend obtaining supplies outside of a patient room to care for patients.
* Determine if implementation of a full time stocking technician decreases the amount of time that nurses spend outside a patient's room obtaining stock.
* Conduct spot checks on carts to determine if PAR levels are over, under, or exactly as established.

Eligibility Criteria:
Inclusion Criteria:

* Nurse is an employee of LVHHN, and is working at the CC site.
* Nurse is working a full shift (7a-7p, 7p-7a, 7a-3p, 3p-11p, 11p-7a).
* The nurse being observed is working in Pod 1, Pod 2, Pod 3, or Pod 4 at the CC site.
* The supply needed is related to a procedural task for patient care.

Exclusion Criteria:

* The nurse is working at LVH-M or LVH-17.
* The nurse being observed is working in the express care area or trauma bay.
* The supply being obtained is a supply that is not maintained in the cart (Appendix 2).
* The nurse is scheduled for a shift less than 8 hours.
Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture

Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing surgery for fracture shaft of femur

Exclusion Criteria:

* Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia
* Patients with known coagulopathy
* Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit \<24%)
* Patients with documented DVT or PE at screening or in past three months
* Patients having known hypersensitivity to tranexamic acid or any other constituent of the product
* Patients with any associated major illness (e.g., severe cardiac or respiratory disease)
* Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week
Construction of a Prediction Model for MACCE in Elderly Patients After Elective Non-cardiac Surgery

Severe cardiovascular and cerebrovascular complications, including cardiac death, non-fatal angina/myocardial infarction, non-fatal heart failure, stroke, severe arrhythmia, etc., are one of the main types of postoperative complications in elderly patients, and are also the main causes of perioperative death in elderly patients. With the aging population and the large proportion of elderly patients undergoing non-cardiac surgery, it is increasingly important to establish a prediction model for postoperative severe cardiovascular and cerebrovascular events in elderly patients undergoing noncardiac surgery.

This project intends to use a multi-center, prospective cohort study method to include about 3000 elderly patients over 65 years old who are planning to undergo non-cardiac surgery, collect relevant data before, during and after surgery, observe the occurrence of serious cardiovascular and cerebrovascular complications in the perioperative period, establish a "MACCE risk prediction model for elderly patients after elective non-cardiac surgery", and verify its effectiveness and reliability. The results of this study will help to improve the predictive ability of postoperative complications of severe cardiovascular and cerebrovascular events in elderly patients undergoing elective non-cardiac surgery, which is conducive to early risk assessment, risk classification, strengthening perioperative patient management, reducing the incidence of postoperative MACCE, and improving the prognosis of elderly patients.

Eligibility Criteria:
Inclusion Criteria:

* The subjects were patients with elective non-cardiac surgery;
* Older than 65 years;
* Patients signed informed consent.

Exclusion Criteria:

* The anesthesia should be received in any of the following ways: local anesthesia;
* local anesthesia enhancement, and simple nerve block anesthesia;
* Patients who are scheduled to undergo day surgery;
* Expected operation time \<1 hour for patients;
* Patients who are expected to stay in hospital for less than 3 days after surgery;
* Patients who refuse to enroll.
Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis

Bronchiolitis is the leading cause of pediatric intensive care unit admission in infants. Seizures during bronchiolitis may be a neurological complication of respiratory viruses but also of the treatments. The investigating team's hypothesis is that the incidence of seizures is not so so uncommon in infants hospitalized in the pediatric intensive care unit for severe bronchiolitis.


Eligibility Criteria:
Inclusion Criteria:

* age \< 90 days
* hospitalization from January 1st, 2010 to April 30th, 2018 in the Pediatric Intensive Care Unit (PICU) of pediatric hospital in Lyon
* with bronchiolitis (clinical diagnosis according to American Academy of Pediatrics)

Exclusion Criteria:

* neurological history that may explain the occurrence of seizures
* significant congenital heart disease
Safety and Tolerability of Repeated Subcutaneous Injections of CAD106 in Mild Alzheimer's Patients.

This study will evaluate the safety and tolerability of repeated subcutaneous injections of CAD106 in patients with mild Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Mild Alzheimer's Disease
* Mini-Mental State Examination (MMSE) 20 to 26 at screening, untreated or on stable dose of cholinesterase inhibitor or memantine over the last 6 weeks

Exclusion Criteria:

* Previously participated in an AD vaccine study and received active treatment
* History or presence of an active autoimmune and/or with an acute or chronic inflammation, and/or clinically relevant atopic condition.
* History or presence of seizures and/or cerebrovascular disease.
* Presence of an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)