cyrilzakka/clinical-trials huggingface dataset:
Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery

To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is effective and safe for the prevention of postoperative inflammation as a consequence of cataract extraction surgery.


Eligibility Criteria:
Inclusion Criteria:

* ≧18 years of age
* able to sign an informed consent and complete all required visits
* intends to have a cataract extraction surgery followed by implantation of a posterior chamber Intraocular lens (IOL)
* Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)

Exclusion Criteria:

* Uncontrolled glaucoma or IOP
* use of ocular anti-infectious during the study and within 30 days prior to the enrollment, secondary implantation or replacement of IOL in the study eye
* use of steroid during the study or within 14 days prior to enrollment
Analysis of the Status, Treatment and Outcomes of Rib Fractures

A retrospective analysis of all patient presenting with multiple rib fractures to the emergency room of Penn State Hershey Medical Center between 2010-2012. Patient demographics, cause of fracture, outcomes, chronic medical conditions, vital signs, length of stay, pain levels and treatment, and sequelae will be recorded and analyzed.

This is a retrospective chart review with follow-up phone calls.

The initial part of the study will be a retrospective chart review. For this chart review study, the following data elements will be entered for each participant.

The investigators will perform a retrospective study of patients who have been treated for rib fractures at Penn State Hershey Medical Center (PSHMC). The time period of review will be 1/10/10 - 1/10/12 until 1500 cases have been reviewed. Data collected will be:

* Patient Medical Record Number (MRN)
* Name
* Phone number
* length of stay (admit and discharge date)
* Number of rib fractures per patient
* Cause of rib fracture
* Characteristics of the fracture (unilateral versus bilateral and multiple versus single)
* Pain management used for the rib fracture including pain interventions, medications and all pain scores
* Complications attributable to the rib fracture, including:

  1. Shortness of Breath (SOB)
  2. Hemothorax,
  3. Pneumothorax
  4. Flail chest
  5. Intubation required
  6. Mechanical ventilation required
  7. Opioids required for pain
  8. Chest tube placement required
* Sequelae of rib fracture, including:

  1. Acute Respiratory Deficiency Syndrome (ARDS)
  2. Pneumonia
  3. Death
  4. chronic pain
  5. delayed subclavian vessel thrombosis
  6. aortic aneurysm
  7. tracheobronchial fistula
  8. thoracic outlet syndrome
  9. Horner's syndrome
* Clinical history of

  1. Rib fractures
  2. Other fractures
  3. Osteoporosis
  4. Chronic Obstructive Pulmonary Disease (COPD)
  5. Cancer
  6. Myocardial Infarction (MI) / Coronary Artery Disease (CAD)
  7. Arthritis
  8. Parkinson's disease
* Patient characteristics:

  1. Age
  2. Gender
  3. Race
  4. Body Mass Index (BMI)
  5. Alcohol use
  6. Smoking status
  7. Marital status
  8. Education
  9. Initial blood pressure

7.2.2 Follow-up phone calls

The investigators will then attempt to call the patients for follow-up information using a summary explanation of research phone script to obtain the following information:

1. pain score
2. quality of life via the EuroQol's quality of life survey :EQ-5D-3L questionnaire
3. pain meds

Eligibility Criteria:
Inclusion Criteria:

* must have above and be notated in our medical record

Exclusion Criteria:

* missing data
Acute Renal Failure in the Surgical Intense Care Units - NTUH-SICU-ARF (NSARF) Study

We examine the prognosis and etiology of postoperative acute renal failure

Postoperative acute renal failure is a serious complication resulting in a prolonged stay and high mortality. Acute renal failure (ARF) develops in 5 to 30% of patients who undergo surgery, and for all causes, it is associated with mortality rates of 60-90%. Despite advances in supportive care and innovations in renal replacement therapies over the past three decades, the mortality rate for these patients remains high. In the previous analysis of NSARF (National Taiwan University Hospital-Surgical Intense Care Unit- acute renal failure database), the mortality rate of acute renal failure patients in SICU is 66.4%, dialysis dependent rate after ARF is 5% and renal recovery rate is 28.6%. Therefore, the issue concerned is to increase the survival rate and renal recovery rate after acute renal failure.

Perioperative ischemic reperfusion injury may result in acute renal failure (ARF), from which patients can invariably recover. However, there remains a large number of patients whose kidneys fail to recover from ARF, and therefore long-term dialysis is required. The dys-regulation of the inflammatory response in critically ill patients has been implicated as an important mechanism underlying the development of multiple organ system dysfunction, septic shock, and death. Furthermore, an increase in oxidative stress is considered an important pathogenic mechanism in the development of ischemic and toxic renal tubular injury. We hypothesize that extensive immune dys-regulation and increased oxidative stress might be an important factor leading to ARF, and/or associated with their all-cause mortality in critically ill patients.

In this study, we will find out (1) first year, the relationship between cytokine storm and free radical storm with urine output during post-surgical ARF, and the effect of renal replacement therapy on serum cytokines and free radical level (2) 2nd year, the difference outcome between low low-efficient daily dialysis (SLEDD), and low low-efficient daily dialysis-hemofiltration (SLEDD-f), the pharmacokinetics of the SLEDD (3) the 3rd year, we sill established the disease severity score of post-operative ARF patients. (NSARF score) and focus on long-term outcomes for survivors of postoperative ARF. From diagnosis to prognosis, we will incorporate important markers of disease diagnosis, treatment and long term outcome. Finally, we hope to improve the mortality and the life quality of postoperative ARF.

Eligibility Criteria:
Inclusion Criteria:

* Postoperative acute renal failure

Exclusion Criteria:

* Patients with ECMO or IABP
EMLA Cream in Hysteroscopy Practice

The aim of this study is to investigate the efficacy of 5% lidocaine 25 mg-prilocaine 25 mg/g cream (EMLA®) applied to the uterine cervix for reducing pain during diagnostic hysteroscopy, using a visual analogue scale (VAS) for pain, and whether it can replace general anesthesia that may be required for some cases of office hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients that must perform a diagnostic hysteroscopy.
2. Acceptance to participate in the study.
3. Signed informed consent.
4. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) 6h before admission.
5. Absence of sedative use 24 h before admission

Exclusion Criteria:

1. Hypersensitivity or allergy to anesthetics
2. refusal of the patient
3. Patients under age 18 and pregnant.
4. Patients on anti-arrhythmic drugs due to possibility of drug interaction.
5. Unbearable pain that involves other analgesic measures.
6. Allergic reactions to topical anesthetics
Sulfation of Bile Acids as a Biomarker for Hepatobiliary Diseases

The investigators hypothesize that the extent of sulfation of toxic BAs and their urinary elimination can be used as a biomarker to predict the severity and prognosis of hepatobiliary diseases. The investigators rationale in this project is that the discovery of biomarkers specific to liver injury would provide the foundation for a specific and non-invasive tool to evaluate disease prognosis, determine patients with higher risk of developing end-stage liver diseases, and determine patients with higher risk of recurrence of hepatobiliary complications after liver transplant.

Patients on the liver transplant list are continuously monitored during their hospitalization and are scheduled for follow-up visits for 12 months after their release post-surgery. Disease progression will be evaluated by monitoring MELD scores, survival, incidence of liver transplant, and incidence of complications related to hepatobiliary conditions such as fluid retention, GI bleeding, encephalopathy, and biliary stricture complications.

The investigators propose the following specific aims to test the investigators hypothesis:

Specific Aim #1: Establish a baseline of individual and total urinary BAs and BA-sulfates in healthy controls and patients with hepatobiliary diseases. A baseline reference of the average and distribution of the percentage of urinary BA-sulfates will be determined in healthy subjects and in patients with hepatobiliary diseases including chronic hepatitis C/B, alcoholic liver disease, hereditary, drug-induced, and autoimmune hepatobiliary diseases. The investigators working hypothesis is that patients' capability to sulfate total or specific BAs, as determined by the percentage of total or specific BAs excreted in the sulfate form, can predict the severity of hepatobiliary diseases, as determined by mayo model for end-stage liver disease (MELD) score and compensation status(compensated and decompensated). Patients with higher MELD score are considered to be at higher risk of developing severe hepatobiliary complications.

Specific Aim #2: Determine the relationship between BA sulfation and the progression of hepatobiliary diseases. This is an exploratory aim to collect preliminary data on the relationship between urinary BAs and the progression of hepatobiliary diseases in liver-transplant and non-liver-transplant patients, as monitored over a1-year period. The investigators working hypothesis is that patients' capabilities of sulfating BAs determine the progression of the disease.

Eligibility Criteria:
Healthy Controls

Inclusion Criteria:

* Male or female, age 19-65, no apparent signs of hepatobiliary diseases

Exclusion Criteria:

* Levels higher than 50, 56, 78 U/L for ALT, AST, and GGT, respectively.

Patient Population

Inclusion Criteria:

* Male or female, age 19-65, visiting the UNMC hepatology clinic for treatment from hepatobiliary diseases

Exclusion Criteria:

* MELD score less than 6
Therapeutic Optimization in Patients in Acute Geriatric Care at University Hospital of Montpellier

This study involves patients who will be discharged from Montpellier University Hospital (acute geriatric care unit) between January and March 2020.

The primary objective is to assess the number of difference(s) in patient's medicines between the discharge from hospital (acute geriatric care unit) and one month after this discharge.

The secondary objectives are:

* to assess the number of changes of medicines between the patient's admission and discharge from hospital (acute geriatric care unit);
* to evaluate the number of inappropriate medicines in patient's treatment at hospital admission (in acute geriatric care unit) and one month after the discharge from hospital;
* to evaluate the number of failures found in the transmission of information between the hospital and the general practitioner/pharmacy one month after the patient's discharge from hospital (acute geriatric care unit).


Eligibility Criteria:
Inclusion Criteria:

* patients who will be discharged from hospital (acute geriatric care unit) between January and March 2020 and who will return to their home or to institution for elderly persons
* patients for whom there will be at least one change in their medicines between their admission and their discharge from hospital

Exclusion Criteria:

* Patients who don't want to participate in this study
Baylor Infant Biomarker of Nutrition Study

The study evaluates the the utility of a non-invasive skin measurement as a biomarker of infant food intake during complementary feeding.

RATIONALE: During infancy, children go from consuming primarily breast milk or formula, to consuming a variety of baby foods and table foods. Doctors, researchers, and community health workers are interested in knowing what foods infants eat, but since many infants have multiple adult caregivers, it can be hard for one caregiver to accurately recall the dietary pattern of the infant. A rapid, non-invasive biomarker of food intake in infants could serve as a useful monitoring tool.

PURPOSE: In order to develop a non-invasive measure of infant food intake, the association between infant dietary patterns, skin carotenoids, and blood carotenoids will be evaluated at 4, 6, and 8 months of age.

OUTLINE: Infants will visit the research center at 4, 6, and 8 months of age for length, weight, skinfold thickness, and skin colorant measures. An infant blood sample will be collected at each visit and lactating mothers will be asked to provide a breast milk sample. The caregiver will complete a food survey at each visit, will keep an infant food diary for a week at 4, 6, and 8 months of age, and will enter the food diaries into an online survey 3 times during each of the diary weeks.

Eligibility Criteria:
Inclusion Criteria:

* 4-4.5 months old at baseline
* born at term (\>/=37 weeks gestation)
* within the 5th-95th weight-for-age percentile (inclusive)
* primary caregiver can speak, read, and understand English
* infants are exclusively breast- and/or formula-feeding at baseline
* consenting parent or caregiver must be 18 years old or older

Exclusion Criteria:

* has a sibling enrolled in the study
* metabolic, digestive, or malabsorptive disorders
* known bleeding or clotting disorder
* requires a special diet
* exposed to tobacco smoke in the home
* currently taking any isolated carotenoid supplements
* using medications or complementary or alternative medications that interfere with dietary fat absorption
* has a history of endocrine disorders requiring hormone administration.
Moyamoya Disease Biomarkers in Patients With Intracranial Atherosclerotic Stroke

The aim of this study is to investigate the proportion of patients with moyamoya disease among the patients who were diagnosed as having intracranial atherosclerotic stroke. To do this, biomarkers (gene and imaging) for moyamoya disease are tested and follow up angiography are performed during follow up (in selected patients).

1. Purpose Both moyamoya disease (MMD) and intracranial atherosclerotic stenosis (ICAS) are more prevalent in Asians than in Westerners, although the reason for the race-ethnic differences is unsettled. It is possible that patients with adult-onset MMD were misclassified as having ICAS, which may in part explain the high prevalence of intracranial atherosclerosis in Asians. It is important to differentiation between these two diseases because MMD and ICAS have differential therapeutic strategies (surgical revascularization in MMD vs. the use of antithrombotics/statins and stenting in ICAS). The ring finger 213 (RNF213) was recently identified as a susceptibility gene for MMD in East Asians. Characteristic high-resolution (HR) MRI findings of MMD and ICAS have recently been reported. The aim of this study is to investigate the proportion of patients with moyamoya disease among the patients who were diagnosed as having intracranial atherosclerotic stroke. To do this, biomarkers (gene and imaging) for moyamoya disease are tested and follow up angiography are performed during follow up (in selected patients).
2. Conditions: Stroke, intracranial occlusive lesion
3. Intervention: None
4. Study period: Jan 22, 2014 \~ Dec 31, 2016
5. Study design: Observational model Time perspective: Retrospective-Prospective

Eligibility Criteria:
Inclusion Criteria:

1. Intracranial atherosclerotic stroke

   * Patients with age over 20 years
   * Patients with focal neurological deficits presented within 7 days of symptom onset
   * Patients with acute ischemic lesions on diffusion-weighted image (DWI)
   * Patients with stenosis on the relevant intracranial vessels (distal ICA and/ or M1)
2. Moyamoya disease

   * Patients with age over 20 years
   * Patients who performed conventional angiography
   * Patients who are diagnosed as having either definite or probable Moyamoya disease
3. Healthy subjects

   * Subjects with age over 20 years
   * Subjects with no history of cerebrovascular disease

Exclusion Criteria:

* Patients with extracranial stenosis more than 50%
* Patients with potential sources of cardio-aortic embolism
* Patients with moderate to severe renal disease
* Pregnancy or lactation
* Patients with short life expectancy
Long-term Treatment with Ustekinumab in Patients with Crohn's Disease and Ulcerative Colitis: a Cohort Study

Monocentric observational retrospective/prospective pharmacological study. Clinical records of patients with Ulcerative Colitis and Crohn's Disease who started therapy with Ustekinumab between February 2019 and March 2021 at the IBD Unit will be reviewed. The main objective is to evaluate the overall persistence of patients with Crohn's Disease and Ulcerative Colitis who started Ustekinumab between February 2019 and March 2021, as well as the impact of treatment on the natural history of the disease. The study involves the collection of follow-up data for a maximum period of 24 months from the start of therapy. For patients who began therapy with Ustekinumab from February 2019 up to 24 months before the start of enrollment, data collection will be conducted retrospectively. For patients who have undergone therapy with Ustekinumab within 24 months prior to the start of enrollment, and up to March 2021, data will be collected both retrospectively and prospectively.

The medical records of patients with Crohn's Disease and Ulcerative Colitis who started therapy with Ustekinumab between February 2019 and March 2021 have been selected. Initially, it was estimated that approximately 350 patients would be eligible for enrollment in the study.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male and female patients, aged ≥18 years
* Patients who began treatment with Ustekinumab according to the indications for marketing authorization, following clinical practice and the information contained in the product's technical data sheet, during the period from February 2019 to March 2021.

Exclusion Criteria:

* None
Tamsulosin Hydrochloride 0.4 mg Capsules Under Fasting Conditions

The objective of this study is to evaluate the comparative bioavailability between Tamsulosin Hydrochloride 0.4 mg Capsules (Teva Pharmaceuticals USA) and Flomax® 0.4 mg Capsules (Boehringer Ingelheim Pharmaceuticals, Inc. USA), after a single-dose in healthy subjects under fasting conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male subjects, 18 years of age or older.
* BMI greater than or equal to 19 and less than or equal to 30.
* Negative for:

  * HIV.
  * Hepatitis B surface antigen and Hepatitis C antibody.
  * Using drugs of abuse test (marijuana, amphetamines, barbiturates, cocaine, opiates, benzodiazepines and methadone).
  * Urine cotinine test
* No significant diseases or clinically significant findings in a physical examination.
* No clinically significant abnormal laboratory values.
* No clinically significant findings in vital signs measurements and a 12-lead electrocardiogram (ECG).
* Systolic blood pressure between 100-140 mmHg and diastolic blood pressure between 60-90 mmgHg.
* Be informed of the nature of the study and given written consent prior to receiving any study procedure.

Exclusion Criteria:

* Known history or presence of any clinically significant medical condition, illness or surgery within 4 weeks prior to drug administration.
* Known or suspected carcinoma.
* Known history or presence of:

  * Hypersensitivity or idiosyncratic reaction to tamsulosin and/or any other drug substances with similar activity.
  * Alcoholism within the last 12 months.
  * Drug dependence and/or substance abuse.
  * Use of tobacco or nicotine-containing products within the last 6 months.
* Use of any prescription medication within 14 days prior to Period 1 dosing. Use of any over the counter (OTC) medication within 7 days prior to Period 1 dosing.
* Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to Period 1 dosing.
* On a special diet within 4 weeks prior to drug administration (e.g. liquid, protein, raw food diet).
* Participated in another clinical trial or received and investigational product within 30 days prior to drug administration.
* Donated up to 250 mL of blood within the previous 30 days OR Donated from 251 to 500 mL of blood in the previous 45 days OR Donated more than 500 mL of blood in the previous 56 days (based on the Canadian Blood Services guideline for blood donation.
* Difficulty fasting or consuming the standard meals.
* Do not tolerate venipuncture.
* Unable to read or sign the ICF.
Application Breathing Exercises With Load Inspiratory Postoperative Abdominal Surgery

The aim of this study is to evaluate the effects of the use of breathing exercises with inspiratory loading on respiratory muscle strength and endurance, lung volumes and capacities and thoracoabdominal mobility in patients after bariatric surgery.

It is believed that the use of inspiratory load may mitigate the negative effects of surgical trauma on respiratory muscle dysfunction, preserving respiratory muscle strength, lung volumes and diaphragm mobility, thus reducing the risk of pulmonary complications in the postoperative period.

This is a prospective, randomized and blinded study, where volunteers will be selected anthropometric measurements, assessment of lung volumes and capacities, through spirometry, thoracoabdominal mobility through the circumference, assessment of inspiratory muscle strength and endurance.

After these evaluations will be done by lottery randomization, where the volunteers will be divided into five groups. They are: control, incentive spirometry to flow, the volume incentive spirometry, Threshold ™, Power breathe ®, according to their resources to be performed during the postoperative period. Each appeal will be held in 6 sets of 15 repetitions, totaling seven sessions, two in the immediate postoperative period, and five on the first postoperative day. At the end of the intervention volunteers will be reassessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 40 and 55 Kg/m²
* Aged between 25 and 55 years
* Submitted to Roux-en-Y type gastric by-pass by laparotomy
* Normal preoperative pulmonary function test

Exclusion Criteria:

* Hemodynamic instability
* Hospital stay longer than three days
* Presence of postoperative complications
* Smoking