cyrilzakka/clinical-trials huggingface dataset:
Lotemax® Gel 0.5% and Restasis 0.05% in Participants With Mild or Moderate Keratoconjunctivitis Sicca (Dry Eye Disease)

This study is being conducted to investigate the safety, comfort, and tolerability of 3 treatments: loteprednol etabonate ophthalmic (Lotemax®) gel 0.5 percent (%) administered twice daily (BID) with or without cyclosporine ophthalmic emulsion (Restasis) 0.05% administered BID, and Restasis 0.05% treatment alone for 12 weeks and at a follow-up safety visit 1 week post-treatment. This study will also investigate the relative efficacy of Lotemax gel 0.5% administered BID with or without Restasis 0.05% treatment administered BID and of Restasis 0.05% treatment alone for the reduction of clinical signs or symptoms of keratoconjunctivitis sicca (DED) over the first 4 weeks of a 12-week treatment period and at the end of a 12-week treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with or treated for keratoconjunctivitis sicca (DED) within 6 months prior to screening visit (Day -14).
* Have a baseline intraocular pressure (IOP) measurement of greater than or equal to (≥) 5 millimeters of mercury (mmHg) and less than or equal to (≤) 22 mmHg in each eye, with or without anti-glaucoma therapy.
* Have mild to moderate DED in 1 eye or both eyes at screening visit (Day -14) and randomization visit (Day 0).

Exclusion Criteria:

* Have a known hypersensitivity to corticosteroids, cyclosporine, fluorescein, lissamine green, topical anesthetic, or any component of either of the study drugs.
* Have severe DED.
* Have corneal erosive disease or other conditions suggestive of extensive damage of the cornea.
* Have a history of elevated IOP, a history of glaucoma, or IOP greater than (\>) 22 mmHg in either eye at the screening visit (Day -14).
* Have had penetrating intraocular surgery in the past 12 months or require penetrating intraocular surgery during the study.
* Have had eyelid surgery within the 6 months prior to Visit 1 (Day -14) or have DED secondary to surgery.
* Have visible evidence of anterior lid Demodex spp. infection or infestation.
* Have had corneal refractive surgery or corneal transplantation.
* Have congenitally absent lacrimal or meibomian glands or have any obstructive disease of the lacrimal glands, sarcoidosis, or any other lacrimal gland deficiency.
* Have a diagnosis of on-going ocular infection, active anterior blepharitis, moderate to severe pinguecula, Stevens-Johnson syndrome, ocular cicatricial pemphigoid, significant conjunctival scarring, ocular chemical burn, or ocular neurotrophic keratitis.
* Have any serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance.
* Have a history of ocular herpetic keratitis or have had active blepharitis in the 4 weeks prior to the first dose.
* Have had ocular surgery (including laser) within 6 months prior to the first Treatment Period, or plan or require ocular surgery during the study. Neodymiumdoped:yttrium aluminum garnet (Nd:YAG) laser posterior capsulotomy is allowed.
Peripheral Choroidal Layer Response

The study aims to examine how the vascular layer of the eyeball (choroidal layer) responds when part of the visual field is exposed to specially generated visual stimulus. The study goal will be accomplished by producing specific blur visual stimulus at a particular visual field position and measure any consistent thickness change pattern in the choroidal layer.

We propose to test the hypothesis that regional changes in the choroidal thickness may be induced differently after short-term exposure to specific visual stimuli.


Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

* Is between the ages of 18 and 40 yrs old
* Has normal best corrected visual acuity being 20/20 or better
* Has spherical refractive error between +1.00D and -6.00D.
* Is capable of fixating on the target.
* Has no prior ocular surgery.
* Has no ocular pathology except keratoconus.
* Can tolerate dilating eye drops

Exclusion Criteria:

A person will be excluded from the study if he/she:

* Does not fall within above mentioned age group.
* Has chronic or systemic eye disease that would interfere with pupil dilation via eye drops.
* Underwent ocular surgeries or history of ocular trauma
* Has shallow anterior chamber angle and/or glaucoma.
* Has clinically significant dry eye.
* Has signs of any choroidal or retinal pathology, and abnormalities in the visual pathway
* Has spherical refractive error that exceeds the limits outlined above.
* Has binocular anomalies (e.g. convergence insufficiency, strabismus, pseudo-myopia, amblyopia).
* Is an adult unable to consent
* Is an individual who is not yet adult (infants, children, teenagers)
* Is a pregnant woman
* Is a prisoner
* Is a student for whom you have direct access to/influence on grades
* Is an economically and/or educationally disadvantaged person
Changes of GCF Levels of RANKL and Osteoprotegerin in Postmenopausal Osteoporosis

The investigators evaluated the effect of initial periodontal treatment on clinical findings and receptor activator of Nuclear Factor-kappa B ligand (RANKL) and osteoprotegerin (OPG) in gingival crevicular fluid (GCF) of patients with osteoporosis under bisphosphonate therapy within 12 months' follow-up. Clinical recordings and GCF were obtained from postmenopausal women; with chronic periodontitis and osteoporosis (Group A, n=13), with chronic periodontitis and no osteoporosis (Group B, n=12), without chronic periodontitis and osteoporosis (Group C, n=12), systemically and periodontally healthy controls (Group D, n=10) at the baseline. Recordings were repeated at the 1st, 6th and 12th months in Group A, B and C. RANKL and OPG values were measured by enzyme-linked immunosorbent assays.

The study groups were selected from postmenopausal patients those referred to Department of Endocrinology, School of Medicine, Ondokuz Mayis University. Bone mineral density (BMD) measurements were performed by dual energy-X-ray absorptiometry from L1-L4 site of lumbar vertebra and/or femur (g/cm2). Osteoporosis was defined as T scores less than -2.5 at L1-L4, femur neck or total femur. Women with T scores less than -2.5 (groups A and C) were started on bisphosphonate treatment after their initial periodontal examination.

Eligibility Criteria:
Inclusion Criteria:

* Women with T scores less than -2.5 (groups A and C)
* The periodontitis patients were selected based on the radiographical evidence of bone loss, presence of four or more sites with bleeding on probing (BOP), ≥5 mm pocket depth (PD) and ≥6 mm clinical attachment loss (CAL).
* The clinically healthy control groups were selected on the basis of no radiographic bone loss or CAL and PD≤3 mm.

Exclusion Criteria:

* Any known systemic disease rather than osteoporosis
* Smoking
* Antibiotic therapy within the last 3 months
* Periodontal treatment within the last 6 months.
Cali Sin Tos Aim 2

The overall objective of this Aim is to design and iteratively adapt a home-based, mHealth- and oral testing facilitated strategy for implementing tuberculosis (TB) contact tracing in Cali, Colombia. Investigators will employ an iterative, community-engaged, participatory co-design process to optimize the feasibility, acceptability, usability, and appropriateness of the mobile health (mHealth) and oral testing strategy, in preparation for a future, appropriately powered implementation-effectiveness trial.

This protocol includes the baseline contact tracing protocol and the procedures for determining adaptations to the mHealth strategy (i.e., nominal group technique).

This study will examine the diagnostic performance of oral samples for TB molecular testing in clinic and household settings; as well as utilize a community-engaged design methodology to iteratively refine a mHealth strategy for implementing contact tracing optimized for feasibility, acceptability, usability, and appropriateness.

There is a Certificate of Confidentiality in place for this study.

After contact tracing procedures have concluded, investigators will administer study instruments to characterize the feasibility, acceptability, appropriateness, and usability of the chatbot. Investigators will also conduct up to \~12 key informant interviews with purposively sampled index persons with TB and their household contacts to elicit views on the mHealth strategy during each cycle (for a total of up to \~36 key informant interviews).

After \~40 households (index persons with TB and their household contacts) have been enrolled using these procedures, and all scales and key informant interviews have been completed, the mHealth implementation strategy will be adapted using nominal group technique. Investigators will repeat this cycle twice for a total of three rounds of design and adaptation of chatbot-facilitated contact tracing procedures.

Eligibility Criteria:
Inclusion Criteria:

For index persons with TB:

* assigned by the SoPH to receive contact investigation services from the study community health worker
* may be of any age (represented by a parent or legal guardian for those age\<18)

For contacts of index persons with TB:

* include the index person's named household contacts, defined as those spending one or more days or nights within the past 3 months sleeping under the same roof as the index person;
* may be of any age (represented by a parent or legal guardian for those age\<18).

Exclusion Criteria:

For index persons with TB:

* who are living outside the city of Cali;
* who lack capacity to agree to testing.

For contacts of index persons with TB:

* who have already been diagnosed with and treated for active TB within the past two years;
* who lack capacity to agree to testing.
S-Frame CT Immobilization Masks For Patients Undergoing Radiation Therapy For Head and Neck Cancer

Immobilization devices such as thermoplastic masks are used routinely in the radiation treatment of head and neck cancer patients. It is important to assess how well they function at preventing patient motion while the radiation treatment is being delivered. (i.e. isocentre set-up margins, patient motion with the mask). If these new thermoplastic masks such as MedTec S-frame allow less movement, then smaller margins are needed during radiation therapy which, in turn, would decrease side effects from the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of mucosal malignancy in the head and neck (H\&N) region
* Undergoing radiotherapy (RT) with curative intent using a lateral parallel pair treatment with an anterior or anterior/posterior low neck filed technique using a MedTec S-frame mask
Association Between the Support of NICU Team and Subjective Health of Parents

Preterm birth is a traumatic event for parents. They cope with threatening and unfamiliar environment of hospital, losing the parental role, and frustration. The NICU team is the main support source for these parents. Support and providing information are most important for parents, as they can have some control, involvement and self confidence during the hospitalization, and also feel healthier. The hypothesis of this study is that better support to parents lead to better subjective health feeling by them.

The study will be held among mothers to infants in NICU who are at least 7 days old. The study will use a questionaire to assess the subjective health feeling and the estimation of the support from the team. Sample size is about 150 mothers.

Preterm birth is a traumatic event for parents. They cope with threatening and unfamiliar environment of hospital, losing the parental role, and frustration. The NICU team is the main support source for these parents. Support and providing information are most important for parents, as they can have some control, involvement and self confidence during the hospitalization, and also feel healthier. The hypothesis of this study is that better support to parents lead to better subjective health feeling by them.

The study will be held among mothers to infants in NICU who are at least 7 days old. The study will use a questionaire to assess the subjective health feeling and the estimation of the support from the team. Sample size is about 150 mothers.

Eligibility Criteria:
Inclusion Criteria:

* Mothers to preterm infants in NICU

Exclusion Criteria:

* Mothers to Infants in NICU who are not preterm
* Mothers to Infants in NICU who died during hospitalization
* Mothers to Infants in NICU who were transferred to another hospital during hospitalization
Different Intravitreal Injection Techniques and Pain Level

The purpose of this study is to determine whether certain intravitreal injection techniques cause less pain than others and would therefore be beneficial for the patient's well being.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving intravitreal anti vascular endothelial growth factor (VEGF) injections
* Informed consent

Exclusion Criteria:

* Dementia or any other reason for cognitive deterioration
* Technical limitations not allowing injecting by the protocol
Intubation of Patients With Odontogenic Abcesses

This study is a comparison of two techniques for endotracheal intubation (Glidescope versus Macintosh) in patients with odontogenic abscesses.

Patients with odontogenic abcesses have to be treated by surgical drainage of the abscess under general intubation with endotracheal intubation. Because of a limited mouth opening and swelling within the oral cavity, intubation can be difficult and sometimes impossible with conventional direct laryngoscopy. Therefore, alternative techniques are desirable. We want to compare the success rate of intubation in these patients using the Glidescope technique vs. conventional Macintosh technique.

Eligibility Criteria:
Inclusion Criteria:

* Patients have to have an abscess which has to be treated surgically.
* Mouth opening (Inter-incisor gap) has to be less than 3.5 cm and more than 1.4 cm.

Exclusion Criteria:

* Age under 18 years.
Comparisons of Blood Pressure Control Ability Between HPI, ClearSight, and Conventional NIBP During Neuraxial Anesthesia in Cesarean Section

The goal of this study is to compare the blood pressure control ability with HPI, ClearSight, and conventional NIBP during neuraxial anesthesia in cesarean section. The main question it aims to answer is:

Anesthesiologists can have a better control of blood pressure during cesarean section with HPI than with conventional NIBP.

During the surgery, the participants will be monitored with standard monitor and HPI with ClearSight and will be randomly assigned to three groups, including HPI group, ClearSight group, and NIBP group. Anesthesiologists will treat intraoperative hypotension with different protocols according to the participants' allocation. Investigators will compare the time-weighted average mean arterial pressure \< 65mmHg with in three groups. Secondary outcomes includes the intraoperative hypotension rate, total duration of hypotension, the hypotension symptoms and signs of parturients.


Eligibility Criteria:
Inclusion Criteria:

* 20 - 50 year-old parturients
* scheduled cesarean delivery
* neuraxial anesthesia

Exclusion Criteria:

* parturients with preeclampsia
* parturients with cardiovascular disease above NYHA functional class 2
* parturients with arrhythmias, preoperative severe hypertension, or other severe cardiopulmonary diseases.
* severe perioperative arrhythmias with or without hemodynamic instability
* failed neuraxial anesthesia or regional blockade level below T6
Pain Prevalence in the Trauma Population

The incidence of pain in the post traumatic population is an area that has little to no investigation. This study seeks to determine the incidence and experience of pain in this vulnerable population at different time points - while in hospital, 4 weeks post injury, 3 months post injury.

This pilot study will be a convenience sample from trauma inpatients at the Sunnybrook Campus. The purpose of the study is twofold: to investigate the prevalence of chronic pain that develops in the trauma population at Sunnybrook, and to see if neuropathic pain exists in this population, acute and/or chronically.

Eligibility Criteria:
Inclusion Criteria:

* Over 16 years of age
* ability to read / write in English
* ability to complete an informed consent

Exclusion Criteria:

* history of chronic pain
* unable to give informed consent
* unable to read / write English
Surveillance of Patients With Adenocarcinoma of the Gastroesophageal Junction or Esophagus

The purpose of this study is to find out more information about patients who have cancer (adenocarcinoma) of the esophagus or gastroesophageal junction (GEJ) who have been treated with chemotherapy and radiation but have not had surgery. The study will follow patients for 5 years to monitor for their cancer and to see how the standard medical care affects the daily life of patients.


Eligibility Criteria:
Inclusion Criteria:

* Adenocarcinoma of esophagus or gastroesophageal junction (nidus of the cancer within 5 cm from the gastroesophageal junction) confirmed by biopsy with clinical stage I, II, or III. The superficial adenocarcinoma of the esophagus will be excluded.
* Received no previous treatment for esophageal cancer.
* Measurable or evaluable disease
* ECOG performance status: 0 to 2 that is able to perform activities of daily living with minimal assistance
* Adequate bone marrow function (hemoglobulin ≥8 g/dl, neutrophil ≥1.5x109/L and platelet ( ≥100x109/L)
* Adequate liver function

  * Bilirubin normal, Meets 1 of the following criteria:
  * Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times upper limit of normal (ULN)
  * AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN
  * AP ≤ 5 times ULN AND AST/ALT normal
* Adequate kidney function (creatinine ≤1.5 UNL and creatinine clearance ≥ 60 )
* Be at least 4 weeks from recent major surgical procedures.
* Patients must be able to understand the nature of the study and give written informed consent
* At least one measurable lesion on CT, MRI or esophageal barium exam.

Exclusion Criteria:

* Age \< 18 years and \>80 years
* Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or hematemesis
* Participating in other clinical trials
* Pregnancy
* Clinically significant and uncontrolled major medical conditions including but not limited to active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements
* any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities
Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer

1. Metastatic gastric cancer patients who failed standard treatment will be enrolled in this study.
2. After consent form, patient-derived cancer cell will be collected and tested with 3 kinds of drugs (sunitinib, gefitinib, imatinib).
3. Drug sensitivity prediction software (IRCR-DReSS) will present level of sensitivity and patients will be treated with sensitive drugs.
4. Patients will be evaluated every 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* age\>-20
* metastatic gastric cancer
* life expectancy \>-3 months
* ascites and pleural effusion that can be drained
* ECOG 0-2
* Proper organ function
* Patients who will be enrolled in sunitinib, gefitinib, imatinib clinical trial

Exclusion Criteria:

* HBeAg, HCV, HIV (+)
* Active infection
* Uncontrolled systemic disease
PATient Navigator to rEduce Readmissions

Staying out of the hospital is valued by patients and their caregivers. Their interests converge with those of hospitals now that high 30-day readmission rates for some conditions place hospitals at risk for financial penalties from the Centers for Medicare and Medicaid Services. This study focuses on developing and testing a program that combines a community health worker (lay patient advocate, acting as a "Patient Navigator") and a peer-led telephone support line to improve patient experience during hospital to home transition.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older on date of hospital admission
2. Hospitalized at the University of Illinois Hospital, Chicago
3. Admission diagnosis, per treating physician, of pneumonia, COPD, sickle cell disease, heart failure, or myocardial infarction
4. Receive medical care on an inpatient medical service

Exclusion Criteria:

1. Unable to understand and speak English
2. Unable/decline to give informed consent
3. Previous participant in PArTNER
4. Planned transfer to another acute care facility
5. Planned discharge to facility other than home (e.g. long term care facility)
6. Currently on hospice or plans to discharge home to hospice
7. Current plans to leave against medical advice
Internet-based Treatment for Chronic Insomnia

Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia.

Design This is a randomized controlled trial with online treatment and waiting list control conditions.

Participants

Participants are adults in Manitoba Canada with chronic insomnia.

Setting

Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Access to high speed internet, insomnia duration \> 6 months and occurring at least 4 nights per week, sleep-onset latency \> 30 minutes and/or time awake at night \> 30 minutes, and/or early morning awakening \> 30 minutes before desired time, at least one type of daytime impairment.

Exclusion Criteria:

* Shift work, acute suicidality, mania, schizophrenia, head injury, alcohol intake \> 14 drinks/week for males, \> 12 drinks per week for females, current or past behavioral treatment for insomnia