cyrilzakka/clinical-trials huggingface dataset:
Influence of Lens Design on Particulate Exchange in the Post-lens Tear Film

This is a 5-visit, controlled, bilateral, randomized, subject-masked, crossover (4 treatments x 4 period), non-dispensing study. Subjects will attend all study visits in their spectacle correction having not worn contact lenses on the day of the visit.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. The subject must be between 18 and 40 (inclusive) years of age at the time of screening.
  4. The subject must own a wearable pair of spectacles and be willing to wear them to each study visit.
  5. The subject must be an adapted soft contact lens wearer in both eyes, having successfully worn contact lenses in the last six months by self-report.
  6. The subject must agree not to participate in other clinical research for the duration of this study.
  7. The subject's refractive cylinder must be \<-1.25DC in each eye.
  8. The subject must have best corrected visual acuity of 0.20 logMAR or better in each eye.

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or breast feeding (self-reported).
  2. Any systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the Investigator's discretion).
  3. Use of topical medication such as eye drops or ointment within 24 hours prior to the study visit.
  4. Any history of anaphylaxis or severe allergy.
  5. Any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.)
  6. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment
  7. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
  8. They have any slit lamp findings of grade 3 or higher (e.g. corneal edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings of \< Grade 3 which in the investigator's opinion would contraindicate contact lens wear.
PACEPro - Mood Management Pilot

Researchers at the University of California at San Diego (UCSD) are conducting a 12-week study to test the PACEPRO program. This program is designed to reduce depression by providing:

Lexapro, an antidepressant medicine...Learn More Physical activity information and pedometer Mood management skills and a Mood Mastery Guide Personalized support from a Family Nurse Practitioner


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with mild to moderate depression
* Are willing to take the antidepressant Lexapro
* Can access and use Email and the Internet
* Are willing and able to be physically active
* Access to a primary care physician

Exclusion Criteria:

Subjects will be excluded from participation for the following reasons:

* Pregnancy or breastfeeding
* Narrow angle glaucoma
* Any uncontrolled medical condition or any medical condition which would represent a contraindication to Escitalopram Oxalate Lexapro® pharmacotherapy. Any concomitant non-psychotropic medications that the physician determines are a contraindication to Escitalopram Oxalate Lexapro® pharmacotherapy Bipolar disorder, or any psychotic or organic mental disorder or dementia
* History of intolerance or allergy to Lexapro, or of prior failed treatment for depression with Lexapro
* Current substance abuse or dependency
* Current active suicidal ideation
* Current use of herbal psychoactive treatments such as St. John's Wort
* Concurrent psychotropic medication is not permitted for 2 weeks prior to randomization (4 weeks in the case of fluoxetine) or at any point after
* Receipt of formal psychotherapy concurrently
* Inability, in the investigator's opinion, to comply with study procedures or assessments
* Inability to exercise
The Surgical Gastrointestinal Diseases Registry Protocol

By placing the medical record information of many subjects into a research registry, researchers will be able to conduct research studies directed at increasing our knowledge about Gastrointestinal Diseases.

Researchers are asking for past, current and future medical record information.

Eligibility Criteria:
Inclusion Criteria:

* Subjects being seen by the University of Pittsburgh Medical Center for gastrointestinal diseases
A Study of LY3478045 in Healthy Participants

The main purpose of this study in healthy participants is to learn more about the safety of LY3478045 and any side effects that might be associated with it. The study will also measure how much LY3478045 gets into the bloodstream and how long it takes the body to get rid of it.

This study has two parts: Part A (one dose) will last about six weeks and Part B (more than one dose) will last about eight weeks for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy participants as determined through medical history and physical examination
* Have a body mass index greater than or equal to (≥)18.5 and less than or equal to (≤)40 kilograms per square meter (kg/m²)
* Have had a stable weight for 3 months prior to screening and enrollment (less than \[\<\]5 percent \[%\] body weight change) and have not received dietary intervention in the 3 months prior to screening and enrollment
* Have safety laboratory test results within the normal reference range for the population or investigative site, or results with acceptable deviations that are judged as not clinically significant by the investigator

Exclusion Criteria:

* Have a history of fructosuria
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG (QT) data analysis
* Have blood pressure greater than (\>)160/90 millimeters of mercury (mmHg) and pulse rate \<50 or \>100 beats per minute (bpm), supine (at screening), or with minor deviations judged to be acceptable by the investigator
* Use of any drugs or substances that are known strong inducers or inhibitors of cytochrome P450 (CYP)3A or organic anion-transporting polypeptides (OATPs) are specifically excluded within 14 days prior to the first administration of study drug and during the study
A Study of Thymic Humoral Factor (THF Gamma 2) in HIV-Infected Patients

To investigate the safety of thymic humoral factor (THF gamma 2), its effect on HIV load based on at least a 75 percent decrease in HIV quantitative PCR RNA copies/ml, and its persistence when administered in combination with an antiretroviral nucleoside derivative (zidovudine; AZT). To assess the effects of THF gamma 2 on T-cells, quality of life, and progression of disease.

All patients receive 12 weeks of AZT before being randomized to self-administer one of two doses of THF gamma 2 or placebo for 15 consecutive days and then twice weekly for an additional 50 weeks.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* AZT or another antiretroviral agent (marketed or investigational under a Treatment IND).
* Primary prophylaxis for Pneumocystis carinii pneumonia (PCP), toxoplasmosis, and Mycobacterium avium-intracellulare (MAI) if patient's CD4 count decreases to \< 200 cells/mm3.
* Other marketed drugs as required.

Patients must have:

* HIV seropositivity and be either asymptomatic or have persistent generalized lymphadenopathy (PGL).
* No history of symptoms in Category B or C of 1993 Case Definition, other than oral candidiasis following previous broad-spectrum antibiotic therapy.
* Mean CD4 of 200-500 cells/mm3.
* HIV-1 positive PCR RNA.
* Ability to self-administer study drug by IM injection.
* Ability to tolerate AZT at 600 mg daily during first 8 weeks of run-in period (if AZT naive) OR tolerated AZT at \>= 500 mg daily for at least 3 months but no more than 12 months prior to randomization.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Malignancy.
* Hematuria.
* Proteinuria \> 1+.

Concurrent Medication:

Excluded:

* Non-antiretroviral agents with known or suspected activity against HIV.
* Investigational new drugs that are not antiretroviral agents distributed under a Treatment IND.

Patients with the following prior conditions are excluded:

Myositis within the past 6 months.

Prior Medication:

Excluded:

* Experimental therapy, including interleukin-2, interferon, erythropoietin, or filgrastim nucleoside within 6 weeks prior to study entry.
* Prior antiretroviral therapy (AZT-naive patients only).

Prior Treatment:

Excluded within 6 weeks prior to study entry:

* Blood transfusion or blood products. Active alcoholism, drug abuse, or a mental or psychiatric problem sufficient to prevent adequate compliance with study.
Exogenous Ketone Supplementation and Exercise Performance

20 healthy recreationally active men and woman aged 18-35 will participate in the study. There will be three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. The three main trials will be separated by at least 1 week. After providing the corresponding treatment, participants will be given 30 minutes and after, they will perform a standardized 10-minute warm-up, followed by the 20 km time trial and a 30-second all-out Wingate test.

Some researchers support that a state of ketosis, reached through the use of ketogenic diet, has the potential to improve athletic. To attain such state, individuals must restrict carbohydrate intake to a maximum of 50g/ day or 10% while keeping protein intake moderate. One of the biggest challenges to achieve and maintain ketosis is complying with the diet due to its restrictive nature. Consequently, manufacturers have developed supplements that can induce a state of ketosis acutely (\~1 hour). Unfortunately, there is very little evidence supporting the use of these supplements to enhance athletic performance. Hyperketonemia (blood ketone concentration \> 0.2 Mm) seems to elevate the rate of utilization of ketone bodies. These changes in substrate utilization may allow athletes to preserve, something that would be advantageous for exercise performance. Ketone salts have been shown to elevate the concentration of ketones in blood and as such they may allow the body benefit from the apparent sparing of carbohydrates. Manufacturers now provide ketones salts combined with other ingredients such as caffeine. However it is unknown whether or not the addition of these ingredients has any positive or negative effect on athletic performance. Caffeine alone has been shown to improve athletic performance in several studies. Therefore, the purpose of this study is to compare the effectiveness of a caffeine free ketone salt supplement vs a caffeinated ketone salt supplement and their effects on a 20km time trial and a 30 second all-out Wingate test.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female recreationally active individuals
* aged 15-35 years
* non regular caffeine users.

Exclusion Criteria:

* Smoker
* Taking part in other research
* Sedentary
* For women, if they are pregnant or become pregnant during the study
* Injury limiting exercise ability.
* Have symptoms or take medication for respiratory disease
* Have symptoms or take medication for cardiovascular disease
* Have symptoms or take mediation for neuromuscular disease
* Use heart rate or blood pressure medications
* Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
Comparing Visual Inspection, Performance Observation, and Aerobic Colony Counts for Evaluating Hospital Cleanliness

This study aims to compare correlation between outcome and performance observations and effectiveness by using aerobic colony counts as a comparator in order to find out which method would be better to be used to assess hospital cleanliness.

Design and Setting We perform a prospective study which is conducted in a 17-bed adult medical intensive care unit with approximately 352 annually admissions at a tertiary hospital in Taiwan from July 2021 to December 2022. Cleaning performance observation will be performed according to the environmental checklist for monitoring terminal cleaning released by Centers for Disease Control and Prevention in 2014, to select sampling areas of high-touch surfaces in patient rooms, including bed controls, bed rails, cart pulls, light switches, machine controls, tray tables and call buttons.

Data collection The housekeepers start to do terminal cleaning after patients are transferred or discharged, the researcher also starts to observe directly the practices of cleaning at the same time and recorded "compliant" or "not compliant" whenever surfaces are cleaned and disinfected properly or on the contrary. The high-touch surfaces are disinfected with solution which contained Sodium dichloroisocyanurate (NaDCC). Right after the surfaces are cleaned, the researcher inspect the surfaces and record "clean" or "not clean" whenever surfaces are free of dust, debris, and stains immediately after terminal cleaning or on the contrary.

Ten minutes after surfaces are cleaned and disinfected, Hygiena Ultrasnap Surface ATP test will be applied to swab a standard 10\*10 cm area on selected surfaces by samping templet. After completing sampling, swabs are replaced back in swab tube and all liquid in bulbs was expelled to activate the reaction. Once activated, samples were read right after shaking swab tube for 5-10 seconds. The ATP readings less than 10 RLU (relative light unit, RLU) are interpreted as "pass".

The designated cleaner and the researcher will be assigned to clean high-touch room surfaces and to be in charge of evaluating and sampling, respectively.

Statistical analysis Descriptive statistics are calculated including numbers, percentage, mean and standard deviation. Inferential statistics are analyzed with SPSS (version 22) to determine correlation between results of performance observation, Visual inspection and ATP interpretation by using Chi-square test or Fisher's exact test. The phi coefficient are calculated to measure strength between two sets of data. The phi coefficient refers to the meaning of Pearson's Correlation coefficients, values 0.01-0.19 as no or negligible, 0.2-0.39 as weak positive, 0.4-0.69 as medium positive, 0.7-1.0 as strong positive.12 The ATP readings were compared between "not compliant" and "compliant", and between "not clean" and "clean" respectively by using Mann-Whitney U test.

Eligibility Criteria:
Inclusion Criteria:

rooms after patients are discharged

Exclusion Criteria:

no
Radioactive Stents for Treatment of Unresectable Biliary Tract Cancer

The purpose of this study is to determine whether radioactive stents and common used plastic stents are effective and safety in the treatment of unresectable biliary tract cancer.

Patients with unresectable biliary tract cancer (intrahepatic or extrahepatic cholangiocarcinoma, or ampullary carcinoma) were enrolled and placed with a stent loaded with radioactive seeds (irradiation stent group) or a conventional plastic stent (traditional stent group). After stent placement, the outcomes were compared in terms of tumor response, progression-free survival, overall survival time, and complications related to the procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients were eligible if they had received a histopathological or cytologic diagnosis of nonresectable, recurrent, or metastatic biliary tract carcinoma (intrahepatic or extrahepatic cholangiocarcinoma,or ampullary carcinoma)
* Patients aged between 18 and 80 years
* an estimated life expectancy of more than 3 months
* Disease had to be measurable by computed tomography scan (as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 criteria
* TNM stage III-IV
* no evidence of cancer of another organ.
* no prior chemotherapy for advanced disease was allowed, but adjuvant/neoadjuvant therapy was allowed
* Karnofsky index of ≥60%
* ECOG index ≥2
* previous technically successful stenting or ENBD derange
* Accept of informed consent

Exclusion Criteria:

* Clinically significant cardiovascular disease
* coagulation disorders
* contraindication of Endoscopic
* pregnant or breastfeeding women
* known sensitivity sensitivity to investigated agents or components
* recent invasive procedure
* prior chemotherapy or radiotherapy for biliary cancer
* refusal of informed consent
Transoral Removal of Specimen During Laparoscopic Gastric Resection

Investigators aimed to present the patients who underwent laparoscopic gastrectomy with transoral specimen extraction.

Minimally invasive surgical procedures such as NOSE (Natural orifice spesmen extraction) and NOTES (Natural orifice translumenal endoscopic surgery) are gradually increasing. The transoral way is probably the least used for NOSE.

Eligibility Criteria:
Inclusion Criteria:

* laparoscopic gastric resection
* Patients aged 18-70 years

Exclusion Criteria:

* other transorally removed organs (appendix, gallbladder, surrenal)
Atrophic Gastritis Predicts the Risk of Gastric Cancer

Despite declining incidence rates, gastric cancer (GC) ranks the fourth leading cause of cancer-related mortality and the fifth most common cancer worldwide, with the highest incidence reported in Eastern Asia. The 5-year overall survival rate of early GC exceeds 90%, which was well above advanced GC. Most intestinal-type GCs follow the Correa cascade-inflammation,atrophy, intestinal metaplasia (IM), dysplasia and subsequent carcinoma. The presence of gastric mucosal atrophy and intestinal metaplasia are important risk factors for GC. The purpose of this study was to investigate the incidence of GC attributed to atrophic gastritis in a region with high incidence of GC.


Eligibility Criteria:
Inclusion Criteria:

* Ability and willingness to participate in the study and to sign and give informed consent
* Biopsies were collected based on the recommendation of updated Sydney system

Exclusion Criteria:

* under 18 or over 80 years old
* history of gastrectomy
* severe systemic diseases or malignancy
Spanish Validation of Tool Questionnaire to Assess Patients´Perception About Antipsychotic Treatment

Non-interventional, prospective study to validate Spanish version of TOOL questionnaire in patients with schizophrenia and bipolar disorder under antipsychotic treatment


Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia and bipolar disorder (DSM-IV criteria)
* Stabilized out-patients
* Treated with the same oral antipsychotic at least in the last month

Exclusion Criteria:

* Participation in another clinical trial within 6 months prior to enrolment into this study
* Administration of a depot antipsychotic medication
The Association of Baseline Characteristics of Male Patients Presented With LUTS and Long Term Clinical Outcomes

Non-neurogenic male lower urinary tract symptom (LUTS) is one of the most common symptom presented in urological clinic. Male LUTS could be a result of a combination of many different conditions, including benign prostate hypertrophy, overactive bladder, diabetes, noctural polyuria, sleep apnoea etc. Also male LUTS has shown to have close relationship with metabolic and cardiovascular conditions. Because of the increasing evidences to suggest a close relationship of cardiovascular condition and metabolic problems and male LUTS, this is a study to retrospective review of the patients assessed in this urology clinic and have a more in-depth assessment of the relationship of the baseline characteristics of these medical conditions with the presenting symptoms, as well as the long term urological and overall clinical outcomes of these patients.

This is a retrospective study.Male patients who presented with lower urinary tract symptom to our centre and assessed in the urology clinic from 2005 to 2019 would be enrolled to the study. This study will be conducted by observation; that is, data will be captured from medical records and central medical system (CMS), but patients will not be contacted. All the demographic and medical background, as well as investigations performed during the assessment including uroflowmetry, post-voiding residual, questionnaires, blood pressure, pulse, vascular assessment and blood result will be collected. Follow-up data including usage of medication, clinical outcomes (such as development of urinary retention, cardiovascular events, need of surgical intervention, mortality etc.) will be captured from the medical records.

Eligibility Criteria:
Inclusion Criteria:

* Men aged between 35 and 90 years old with LUTS/nocturia and received assessment at urology centre.

Exclusion Criteria:

* Men having history of prostatic surgery, prostate cancer, active urinary tract infection, aortic aneurysm, marked cardiac arrhythmia and severe peripheral vascular disease
Cryotherapy Against Oral Mucositis After High-dose Melphalan

In this prospective, randomised, controlled, open-label, Phase III, non-inferiority clinical trial trial patients with a diagnosis of myeloma who were undergoing autologous HSCT were randomised 1:1 to receive cryotherapy for 7 hours or 2 hours . Oral mucositis was evaluated prospectively.

We searched MEDLINE and PubMed with the following phrases: "oral mucositis", "oral toxicity", "cryotherapy", "myeloma", "autologous haematopoietic stem cell transplantation", "randomised trial" and "high-dose melphalan".

Oral mucositis, which is a side effect of high-dose chemotherapy, has a major negative impact on the quality of life and survival of patients who undergoing autologous haematopoietic stem cell transplantation (auto-HSCT). For patients with myeloma cryotherapy gives a significant reduction in oral mucositis. The mechanism of action is suggested to be vasoconstriction that is induced by the cooling of the oral mucosa, thereby protecting it from the cytotoxic effects of the chemotherapy. The therapeutic efficacy of cryotherapy in this setting has been confirmed in several trials, it is currently regarded as the standard of care prophylactic regimen for oral mucositis in patients undergoing auto-HSCT for myeloma. However, the long duration of the treatment (7 hours), as reported in the original, placebo-controlled study in 2006, has been associated with significant discomfort for the patients, with negative consequences for compliance.

Uncontrolled trials have previously tested cryotherapy for less than 7 hours in patients with myeloma who receive auto-HSCT. At the time of the planning of the current study in 2014, those results were not yet confirmed in any randomised trial. However last year a randomised trial was published, showing that 2-hour cryotherapy is equally as effective as 6-hour cryotherapy in preventing oral mucositis in patients with myeloma who are treated with high-dose melphalan. The present prospective, randomised study aimed to investigate whether 2 hours of cryotherapy is as effective as 7 hours of cryotherapy in protecting against oral mucositis those patients who are subjected to high-dose melphalan as a conditioning agent for auto-SCT for myeloma.

Eligibility Criteria:
Inclusion Criteria: myeloma, autologous HSCT -

Exclusion Criteria:

-