cyrilzakka/clinical-trials huggingface dataset:
LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.

A Phase 3, Multi-Center, Double-Masked, Vehicle Controlled, Randomized, Parallel-Group Study to Assess Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.

Eligibility Criteria:
Key Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
2. Be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
3. Be willing and able to comply with all treatment and follow-up/study procedures.
4. Be a candidate for routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens \[IOL\] implantation, not combined with any other surgery).
5. In the Investigator's opinion, have potential postoperative pin-holed Snellen visual acuity (VA) of at least 20/200 in the study eye at Visit 1 (Screening) and at least 20/200 in the fellow eye.

Key Exclusion Criteria:

1. Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
2. Be a female subject who is pregnant or breastfeeding.
3. Be monocular (fellow eye is nonfunctional or fellow eye's pinhole vision is worse than Snellen 20/200).
4. Have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to Visit 1 (Screening).
Evaluation of the Performance of the Motus Cleansing System

The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.

Subjects indicate for colonoscopy procedure undergo a limited bowel preparation including 20 mg Bisacodyl (4\*4 tables of 5 mg each) in split dose undergo standard colonoscopy with MCS.

following the procedure 2 follow-up call were conducted at 48 hours and 14 days after to the procedure.

Eligibility Criteria:
Inclusion Criteria:

* Subjects in the age range of 18-75 years
* Subjects with BMI within the range of 18.5-35
* Subject is willing to sign informed consent form

Exclusion Criteria:

* Active or severe IBD
* Subjects with severe diverticulitis \\ diverticular disease (known or detected)
* Known or detected colonic stenosis
* Known or detected bowel obstruction
* History of prior colon surgery
* ASA≥IV (sever systemic disease)
* Sever Renal insufficiency
* Sever Liver insufficiency
* Contraindication for "colonoscopy" anesthesia \\ sedation \\ prep agent pregnancy
* Subjects with altered mental status/inability to provide informed consent
* Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly
Effect of Goal-directed Fluid Therapy on Postoperative Complications

* It has been known that the recent application of a goal-directed fluid therapy (GDFT) to the intraoperative fluid infusion in patients contributes to decreasing the prevalence of postoperative complications and shortening the length of study in the intensive care unit as well as hospital stay compared with conventional methods.
* Laparoscopic surgery is in a trend that its application is being expanded recently, but there has been no report on the application of GDFT to laparoscopic surgery so far.
* To this end, this study aims to apply the intraoperative GDFT protocol in patients undergoing laparoscopic hepatobiliary or pancreatic surgery and to find out whether there is any difference in postoperative recovery and incidences of postoperative complications, by comparing with patients applied with the fluid therapy using existing conventional methods


Eligibility Criteria:
Inclusion Criteria:

* Laparoscopic hepatobiliary or pancreatic surgery

Exclusion Criteria:

* Patients who do not consent to participation in the study
* Pregnant women, breastfeeding women
Predicting Oxycodone Dose From Oral Fluid Drug Levels

This study will develop and test an algorithm that will estimate drug dosage from drug levels measured in oral fluid (saliva). Traditionally, urine has been used as the principle medium to monitor drug compliance in patients receiving opioids for chronic pain as well as those being treated for substance abuse. Recently, the use of saliva as an alternative to urine drug testing has been gaining in popularity. Oral fluid has several advantages over urine as a medium for drug screening. In this study, oral fluid, urine and blood specimens will be collected from volunteer patient donors with chronic pain taking opioid medications. Samples from the anonymous donor will be analyzed for opiate class drugs, using New York State Department of Health approved and validated laboratory methods. Analytical results and other information collected will assist in evaluating the use of oral fluid as a specimen to detect opiate drug levels. The measurement of drug concentrations in blood and oral fluid simultaneously will allow for the determination of the amount of oral fluid that will be needed for successful drug testing. It is proposed that by measuring oral fluid drug levels an estimate of the amount of drug taken will be possible.

Each potential subject will be requested to verify their willingness to participate in the study by signing and dating an Informed Consent Form and the Health Insurance Portability and Accountability Act (HIPAA) Authorization for use of protected health information in research.

The donor will produce a sample by placing a collection swab under his or her tongue until the indicator window turns blue. To ensure the validity of the sample, the donor may not eat, drink, or consume candy for ten minutes prior to the collection time.

A second oral fluid sample will be obtained for the purpose of determining salivary pH at the time of collection. The donors will expel oral fluid into a small collection cup or spoon, and the collector will determine pH using specialized pH strips.

Urine samples will be collected from donors in approved specimen cups according to protocols indicated by the New York State Department of Health guidelines. Blood samples will be collected by trained and certified medical professionals using appropriate collection tubes.

Participating donors will also be requested to complete a questionnaire regarding information including age, weight, and medication information (including type of medication, dosage, dosing pattern, and time of last dose), and medical history (concerning known health issues).

Eligibility Criteria:
Inclusion Criteria:

* Adults between 18 and 72 years of age
* Chronic pain patient at Weill Cornell Medical College Pain Medicine Center

Exclusion Criteria:

* taking any medications that can alter the metabolism of oxycodone or oxymorphone in the body
* not a chronic pain patient at Weill Cornell Medical College Pain Medicine Center
Evaluation of New Specifications (2.25mm) of FirehawkTM in the Treatment of Coronary Heart Disease ( Firehawk_2.25 )

The purpose of this study is to evalute the clinical safety and effectiveness of released specification (2.25mm) of FirehawkTM Sirolimus target-eluting coronary stent system.


Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years of age, males or non-pregnant women;
2. Evidence of silent ischemia, stability or in patients with old myocardial infarction or unstable angina;
3. Primary target lesion, in situ coronary artery disease;
4. Target lesion length ≤ 60mm, target lesion diameter 2.25mm (Visual method);
5. The target lesion diameter stenosis ≥ 70% (Visual method);
6. Each target lesion implantation the same stent (Firehawk stent);
7. With indications for coronary artery bypass surgery;
8. To understand the purpose of testing, voluntary and informed consent, patients agreed to achieve invasive imaging and clinical follow-up.

Exclusion Criteria:

1. Within 72h of any acute myocardial infarction;
2. Unprotected left main coronary artery disease, triple vessel lesions which need treated all; bifurcation lesions and vascular lesions of the bridge;
3. Severe calcified lesions that cannot be successfully expanded and distorting lesions not suitable for stent delivery;
4. Artery and/or vein bypass graft lesions;
5. Intracoronary implantation of any branding stents within 1 year;
6. Severe congestive heart failure (NYHA class III and above), or left ventricular ejection fraction \<35% (ultrasound or left ventricular angiography);
7. Preoperative renal function serum creatinine \>2.0mg/DL;
8. Bleeding, active gastrointestinal ulcers, brain hemorrhage or subarachnoid hemorrhage and half year history of ischemic stroke, antiplatelet agents and would not allow an anticoagulant therapy contraindications patients undergoing antithrombotic therapy;
9. Aspirin, clopidogrel, heparin, contrast agent, poly lactic acid polymer and rapamycin allergies;
10. The patient's life expectancy is less than 12 months;
11. Top participated in other drug or medical device and does not meet the primary study endpoint in clinical trials time frame;
12. Researchers determine patient compliance is poor, unable to complete the study in accordance with the requirements;
13. Heart transplantation patients.
Efficacy and Safety of Olanzapine for the Treatment of Nausea and Vomiting in Palliative Cancer Care

Oral olanzapine showed superior antiemetic efficacy to metoclopramide as rescue treatment to control breakthrough emesis induced by chemotherapy. This study aims to evaluate safety and efficacy of olanzapine for nausea and vomiting in advanced cancer patients.

This will be a pilot study; open-label prospective clinical trial. Oral olanzapine 5 mg tablet will be given to patients who fail two standard treatment medications for nausea and vomiting within 30 minutes after the first vomiting episode. Other doses of olanzapine will be given at 12, 24, and 36 hours following the first dose concurrently with standard regimen.

Patients with emesis will be followed up after receiving olanzapine every 12 hour for 48 hours. We will record the frequency of vomiting, nausea, and retching.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years.
2. Diagnosis of advanced malignancy.
3. Failed two standard medications for nausea/vomiting (after 6 hours from last dose).
4. Adequate organ function, including the following:

   1. Hepatic: bilirubin ≤1.5 times the upper limit of normal (x ULN); aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤3.0 x ULN (AST, and ALT ≤5 x ULN is acceptable if liver has tumor involvement), alkaline phosphatase (AP) ≤5.0 x ULN.
   2. Renal: calculated creatinine clearance (CrCl) ≥30 mL/min based on the original weight based Cockcroft and Gault formula.
5. Expected life expectancy \> 1 month.
6. Patients must be able to read Thai.
7. Patients must sign an informed consent document.

Exclusion Criteria:

1. Patients with history of abdominal radiotherapy.
2. Patients who receive chemotherapy within 1 week.
3. Patients who take fluoxetine.
4. Patients with heart failure or myocardial infarction in the past 6 months.
5. Patients with QTc prolongation from baseline ECG.
6. Known hypersensitivity to olanzapine.
7. Patients who are unwilling to participate in the study.
Different Anesthesia Maintain Protocol Effect the Outcome of the Patients

This prospective open-label randomized study, patients were having elective urological surgery scheduled to last longer than 1 h under necessitating general anesthesia.Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3 mg kg-1 min-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued to maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase

Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3 mg kg-1 min-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued to maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase. Due to the ethical requirements of adequent analgesia, 0.3 μ g kg-1 min-1 remifentanil was continuously pumped as background input dose during anesthesia maintenance in all groups.

Eligibility Criteria:
Inclusion Criteria:

* the aged 18-65 yr,
* ASA physical status I, II or III patients
* having elective urological surgery
* operation scheduled to last longer than 1 h
* under necessitating general anesthesia

Exclusion Criteria:

* refused to participate in the study;
* were not able to communicate due to alterations in the level of consciousness, - a history of allergy to opioids
* contraindications inhalational anaesthesia
* family history of malignant hyperthermia
* alcohol or drug abuse
* received central nervous system-active drugs;
* body mass index ≥40 kg/m2
* represent conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics
* previous head injury, neurologic or psychiatric disease
* any disabling central nervous
* cerebrovascular disease
* current use of psychoactive or anti-convulsive medications
* unstable angina
* manifest congestive heart failure
* airway management was expected to be difficult
Study of BLU-808 in Allergic Rhinoconjunctivitis

This study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of BLU-808 in participants with ragweed (Ambrosia artemisiifolia)-induced allergic rhinoconjunctivitis (ARC). Participants will undergo eligibility assessments that include exposure to ragweed pollen in an allergen exposure chamber (AEC).


Eligibility Criteria:
Key Inclusion Criteria

1. Adults, 18 years of age or older, willing to provide written informed consent, and willing to comply with all study requirements.
2. History (\>2 years) of ragweed-induced ARC.
3. A positive ragweed skin prick test (mean diameter of ≥ 5 mm) in the last 6 months.
4. Must meet clinically relevant nasal and ocular symptoms as defined by the protocol.

Key Exclusion Criteria

Participants are excluded from the study if any of the following criteria are met:

1. Receiving medications (oral, nasal, topical, ocular, or injectable) to treat their ragweed or other allergy symptoms and/or receiving any medications that impact participants' safety or interfere with study assessments or interpretation of study results.
2. Have active rhinitis, sinusitis, and/or other severe allergies not associated with the ragweed pollen that may interfere with study symptom assessments.
3. Any prior or ongoing clinically significant illness, medical or psychiatric condition, surgical history, or physical finding that may interfere with the assessment or interpretation of study results.
4. Clinically significant moderate to severe, uncontrolled cardiovascular, renal or hepatic disease.
5. Significant bleeding risk or coagulation disorders.
6. Any form of smoking, vaping or history of alcohol and drug abuse.
7. Any malignancy within the past 5 years prior to Screening/AEC 1, except for basal cell or squamous cell carcinomas of the skin or carcinoma in situ.
8. Inadequately controlled asthma that could affect the safety of the participant or interfere with the assessment or interpretation of study results.
9. Known active/latent infection (viral, bacterial, fungal, helminth, or mycobacterial) such as tuberculosis, hepatitis B, hepatitis C, AIDS-related illness, or COVID-19 infection.
10. History of sinonasal conditions that may confound the assessment or interpretation of study results.
Long-Term Safety Follow-Up Study of SCM-AGH in Subjects Who Participated and Administered SCM-AGH in to Severe Atopic Dermatitis Clinical Trials

This is a long-term safety follow-up study of the Phase I/II multicenter study of SCM-AGH in subjects with moderate to severe atopic dermatitis. subjects will be followed up for a maximum period of 240 weeks after the first dose of investigational product. Only subjects previously enrolled in protocol ADT2002 (ClinicalTrials.gov ID: NCT04179760) will be eligible for this long-term follow-up protocol.

Subjects who meet all eligibility criteria for Long Term Follow Up(LTFU) study participation at the ADT2002 End of Treatment(EOT) visit may continue LTFU for a maximum period of up to 240 weeks post first dose of investigational product. No additional dosing will be administered on this LTFU protocol.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who provide written informed consent
2. Subjects who have received at least 1 dose of SCM-AGH in the ADT2002 study
3. Subjects who are willing to comply with the visit schedule and study requirements for reporting relevant information to the site.

Exclusion Criteria:

1. Subjects who are unable to comply with the visit schedule prior to Week 240 after first dose of SCM AGH
Multicentre Prospective Clinical Database for the Construction of Predictive Models on Risk of Intrauterine Adhesion

1. To establish a follow-up database for uterine adhesions and a library of biological specimens for Intrauterine Adhesion. 2. using epidemiological surveys and biological analyses to screen risk factors for the development and prognosis of Intrauterine Adhesion. 3. Predictive models based on clinical and biochemical indicators, specimen testing and hysteroscopic images are also combined with statistical analysis and machine learning algorithms to enable patients' risk stratification and prognostic assessment.


Eligibility Criteria:
Inclusion Criteria:

* Previously diagnostic hysteroscopy confirmed adhesions combined with infertility or recurrent pregnancy loss (early pregnancy loss \>2)
* Desiring to conceive
* Ages between 20-45 years;
* Patients without gynecological endocrine disorders (e.g. PCOS) and AMH\>1ng/ml;
* Signing informed consent.

Exclusion Criteria:

* Hysteroscopy contraindications;
* Hormone therapy contraindications;
* Pregnancy contraindications;
* History of malignant pelvic tumor and radiotherapy;
* Severe hepatic or renal dysfunction;
* Complicated with hematological disorders (eg.platelet dysfunction, severe anemia, blood-borne infections);
* Male factor infertility(eg.seminal abnormalities).
Choline Source, Gut Microbiota and Trimethylamine-N-oxide Response

The purpose of this research is to determine the production of trimethylamine-N-oxide (TMAO) from different forms of choline and whether this response is modified by the gut microbiota composition.

The overall goal of this research is to identify dietary and physiological factors contributing to elevated levels of trimethylamine-N-oxide (TMAO), a choline-derived gut-microbiome-dependent metabolite that has been identified to increase cardiovascular disease risk. Our recent findings indicate that the gut microbiome may account for variations in TMAO levels, whereby those with a greater enrichment of Firmicutes to Bacteroidetes had elevated TMAO response to dietary precursor intake. However, the interaction between choline intake and gut microbiota composition as a determinant of interindividual variations in TMAO response has not been investigated. This study sought to i) compare plasma and urinary TMAO response after acute challenge containing different forms of choline; and ii) to determine the association between differences in TMAO response with differences in gut microbiota composition. To accomplish these objectives, a randomized, controlled cross-over study was conducted in healthy participants (n=41). The study incorporated three arms comprised of study meals containing (i) 600 mg choline as choline bitartrate; (ii) 600 mg choline as phosphatidylcholine; or (iii) no choline. Each meal was served with a bagel with margarine-butter spread and one cup of water, administered in a single day and separated by a 1-week washout period. Baseline blood sample was obtained by a phlebotomist using a standard venipuncture procedure, and participants collected their baseline urine sample. They also turned in a one-time self-collected baseline stool sample. Following the consumption of the study meal, serial blood samples were collected at 30 min and 1, 2, 4 and 6 h, and urine samples collected throughout the 6 h study period. At 4.5 h, participants were provided a fixed fruit snack (i.e., 2 single serving prepackaged applesauce) and water.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women of any race or ethnicity
* Age 21-50 y
* BMI 20-24.9 kg/m2 or BMI 30-39.9 kg/m2

Exclusion Criteria:

* Age \> 50 y
* BMI outside of the normal-weight or obese range (BMI \< 20 kg/m2; BMI 25-29.9 kg/m2; or BMI \> or = 40 kg/m2)
* Pregnant or planning to become pregnant during the course of the study; currently breastfeeding (females)
* Vegetarians
* Smokers or recreational drug users
* Individuals with gastrointestinal diseases or complaints, chronic illnesses or other metabolic diseases (including trimethylaminuria)
* Individuals who have taken antibiotics within the past 2 months
* Individuals who are not willing to discontinue pre- and probiotics and dietary supplements for the time leading up to 2 months before the study and during the study