cyrilzakka/clinical-trials huggingface dataset:
Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment

A randomized, single-site, parallel-group, prospective study of patients who are candidates for SLT, to study the effect of IOP change with Rocklatan vs artificial tears.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years and older
* Documented diagnosis of mild to moderate primary open angle glaucoma or ocular hypertension. Diagnosis of primary open angle glaucoma must be supported by the following:

  * 24-2 SITA faster within the last 6 months

    - With a mean deviation of 0 to -12 dB, excluding patients that meet severe criteria by having defects involving fixation or in two hemispheres.
  * OCT RNFL and optic nerve examination within the last 6 months

    * Diffuse or focal narrowing or notching of the optic disc rim, progressive narrowing of the neuroretinal rim, diffuse or localized thinning of the parapapillary RNFL, optic disc asymmetry of the two eyes consistent with loss of neural tissue, or thinning of the RNFL/GCA on examination or imaging
    * Progressive thinning on SD-OCT of 7 microns in inferior and superior quadrants or \>4 micron loss in global RNFL thickness
    * Deviation from this ISNT rule (inferior, superior, nasal and temporal order of RNFL thickness with the inferior RNFL quadrant being the thickness)
* Candidate for bilateral SLT
* Post-washout, post-SLT IOPs between 28-10
* Gonioscopy findings of Schafer grade III and IV

Exclusion Criteria:

* Patients MD \<-12, HVF defects in both hemispheres or involving fixation
* Medication conditions that prevent SLT
* Prior use of rho kinase inhibitor
* Previous SLT performed on either eye
* Prior MIGS implanted in either eye
* Prior or current intolerance of a Rho kinase inhibitor
* Uncontrolled IOP on maximum tolerated medical therapy; unable to washout
* Narrow angles or other angle abnormalities
* History of corneal disease or dystrophy, including endothelial dysfunction
* History of corneal edema
* Current or history of intra-ocular infection or inflammation
* History of retinal diseases that will could affect diagnostic testing
* Anticipated use of intra-ocular or topical steroids not associated with the study protocol
* Current participation of study drugs or devices or within 6 months prior to screening
* Pregnant or planning to be pregnant throughout the study
* Any condition in the opinion in the investigator that would potentially confound the results of this study
Allergy Towards Grass and Bronchial Inflammation - Related to Immunotherapy and Exhaled Nitrogen Oxide

The purpose of this study is to evaluate the immunomodulatory effect of treatment of allergic rhinitis symptoms with specific immunotherapy by measurement of pulmonary inflammatory markers, and among others, exhaled nitric oxide.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years old
* Skin prick test or RAS test and physical examination conclude that the patient will have a beneficial effect from specific immunotherapy

Exclusion Criteria:

* Other diseases except atopic disease
* Pregnancy
Resolution of Neuro-muscular Block in Great Obese Patients: Neostigmine vs Sugammadex

It is a observational prospective study. The aim of this study is to compare neostigmine vs sugammadex in the resolution of neuro-muscular blockade in great obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Great obese
* Videolaparoscopic surgery

Exclusion Criteria:

* Age under 18
* No acceptation of informed consent
* New York Heart Association \> 2
A Study of Tirzepatide (LY3298176) Versus Insulin Lispro (U100) in Participants With Type 2 Diabetes Inadequately Controlled on Insulin Glargine (U100) With or Without Metformin

The purpose of this study is to compare the safety and efficacy of the study drug tirzepatide to insulin lispro (U100) three times a day in participants with type 2 diabetes that are already on insulin glargine (U100), with or without metformin.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 2 diabetes mellitus (T2DM)
* Have HbA1c between ≥7.5% and ≤11%
* Have been treated for at least 90 days prior to day of screening with once or twice daily basal insulin with or without stable dose of metformin ≥1500 mg/day and up to maximum approved dose per country specific approved label, sulfonylureas or dipeptidyl peptidase 4 inhibitors
* Be of stable weight (± 5%) for at least 90 days
* Have a BMI ≥23 kilograms per meter squared (kg/m²) and ≤45 kg/m² at screening

Exclusion Criteria

* Have type 1 diabetes mellitus
* Have had chronic or acute pancreatitis any time prior to study entry
* Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy requiring immediate or urgent treatment
* Have disorders associated with slowed emptying of the stomach, have had any stomach surgeries for the purpose of weight loss, or are chronically taking drugs that directly affect gastrointestinal motility
* Have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
* Have been taking weight loss drugs, including over-the-counter medications during the last 3 months
* Have an estimated glomerular filtration rate \<30 mL/minute/1.73 m² \[for participants on metformin, estimated glomerular filtration rate \<45 mL/min/1.73 m2 (or lower than the country-specific threshold for using the protocol-required dose of metformin per local label)\]
Risk Factors and Complications of Ventral Hernia Repair

The aim of this study is to evaluate risk factors and complications of ventral hernia repair. A retrospective study of journal files with patients undergoing ventral hernia repair, and an analyses of complications by use of the Clavien-Dindo classification of surgical complications.


Eligibility Criteria:
Inclusion Criteria:

* Surgically treated ventral hernia repair

Exclusion Criteria:

* All surgically treated patients are included
Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection

Aim:This study was conducted to investigate the effects of music, kaleidoscope and video watching methods on children's pain perception and anxiety level during the blood collection procedures.

Methods: This randomized controlled experimental study was carried out with 134 children in the 5-10 age group in the pediatric blood collection unit of a Training and Research Hospital between August and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Music Group (n=33), Kaleidoscope Group (n=36), Video Group (n=31). The routine blood collection procedure was used for the children in the control group (n=34). The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)", and the "Wong-Baker Faces Pain Rating Scale (WB-FPRS)".


Eligibility Criteria:
Inclusion Criteria:

* being healthy
* ability to express himself/herself verbally
* no analgesic taken in the last 6 hours
* having no visual or auditory problems

Exclusion Criteria:

* chronic disease
* mental disease
* neurological disease
Dat'Aids Prevention

DatAIDS prevention is a cohort study of HIV prevention in over 23 HIV sites in France including overseas, aiming to describe HIV prevention in every aspect including HIV screening, STI and hepatitis screening, post-exposure prophylaxis and pre-exposure prophylaxis


Eligibility Criteria:
Inclusion Criteria:

* Male and female over 18 years old,
* HIV negative
* Attending for :
* HIV screening
* Hepatitis screening
* STI screening / treatment
* Blood, body fluid or sexual exposure
* Post-exposure prophylaxis
* Pre-exposure prophylaxis
* Signed consent

Exclusion Criteria:

* HIV-infection
* Refusal to participate
Comparison of Different Refraction Measurements in Adults

The combatant is likely to carry out missions any time, any place, day or night. The very strong degradation of natural vision performance in these conditions justifies the use of visual replacement means, based on optronic sensors whose sensitivity is more adapted to these luminous environments than that of the human eye.

The duration and repetition of missions carried out with night vision sensors lead to visual complaints from users.

The literature on night vision binoculars adjustment states that a binocular adjustment of the equipment provides more convex settings. The latter would then limit the strain on the accommodative component, which is one of the possible sources of operator visual fatigue. In order to allow a more appropriate adjustment, it is proposed to rely on a measurement of the refraction (optical defect of the eye) of each operator. Like binocular adjustments, binocular refractive methods would limit accommodative stimulation and thus visual fatigue. However, these methods are little used in favour of conventional methods. It is therefore necessary to evaluate the interest of binocular refraction for the adjustment of night vision binoculars.

The purpose of this study is to compare refraction measurements by procedure in adult subjects free of ophthalmological disorders.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 ;
* Non-presbyopic subject;
* Stereoscopic acuity ≤ 60 arc seconds.

Exclusion Criteria:

* Accommodative insufficiency;
* Accommodative inertia;
* Compensation by orthokeratology (i.e. night lenses);
* Present or past binocular pathology (strabismus or amblyopia);
* Pregnant or nursing woman;
* Incomprehension of French (written and spoken).
Real World Study of Diagnosis and First-line Treatment Among Patients With Cancer of Unknown Primary in China

This study is a prospective, real world study.The objective is to observe the diagnosis and first-line treatment of Chinese patients with cancer of unknown primary, and collect the clinicopathological characteristics, treatment outcomes, survival and other data of the patients.


Eligibility Criteria:
Inclusion Criteria:

* Had a diagnosis of cancer of unknown primary (CUP) after a standard evaluation .
* Prepared to receive first-line therapy for CUP

Exclusion Criteria:

* Patients who had previously received systemic therapy for CUP
* Previous history of other cancers, except cervix cancer or basal cell carcinoma of the skin that has been cured
* The investigator considered that there were contraindications to treatment or were not appropriate to participate in this study
Effects of Chocolate on Motor Symptoms of Parkinson's Disease

Chocolate consumption has long been associated with enjoyment and pleasure. Popular claims confer on chocolate the properties of being a stimulant, relaxant, euphoriant and antidepressant. These possible pharmacological actions might be related to various biogenic amines, such as serotonin, dopamine, tyramine, histamine, phenylethylamine and cannabinoid-like substances. Most amines are metabolized by monoamineoxidase-A (MAO-A) and are therefore unable to pass the blood-brain-barrier. In contrast, phenylethylamine is a direct dopamine releasing ingredient and as a substrate of MAO-B and due to its lipophilic structure even capable to pass the blood-brain-barrier. Within this line, own clinical observations suggested an increased chocolate consumption in patients with Parkinson's disease (PD) compared to healthy subjects and to their pre-disease state.

In a previous study, we assessed the consumption of chocolate and non-chocolate sweets in PD patients and their partners (as household controls) using a self-questionnaire. Consumption of chocolate was significantly higher in PD patients compared to controls, while consumption of non-chocolate sweets was similar in both groups. Our study suggests that chocolate consumption is increased in PD independent of concomitant depressive symptoms measured by BDI-1. Although reasons for increased chocolate consumption in PD remain elusive, it may hypothetically be a consequence of the high content of various biogenic amines as a content of cocoa influencing dopamine metabolism.

Therefore, in the present study we aim to study the effects of dark chocolate with high cocoa content (85%) compared to chocolate without any cocoa (white chocolate) on motor symptoms in PD patients as measured with UPDRS part III (motor score). The principle design of the intervention is similar to the standard pharmacological challenge test for studying effects on motor symptoms in PD (e.g. levodopa challenge test).


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 Years or older
* Idiopathic Parkinson's disease, according to UKBB criteria
* Hoehn \& Yahr Score II-III
* 16 Points or more in UPDRS part III scale
* Sufficient ability to follow the study procedure for at least 3 hours
* Ability to give informed consent
* Stable antiparkinsonian medication for at least 4 weeks prior to study inclusion

Exclusion Criteria:

* Psychiatric conditions, severe enough to interfere with study procedures
* motor or affective fluctuations or dyskinesias
* treatment with COMT and/or MAO inhibitors
* Diabetes mellitus
Evaluation of the Effects of Cannabidiol (CBD) Compared to Delta-9-Tetrahydrocannabinol (THC) and Alprazolam

The purpose of this study is to evaluate the abuse potential of CBD to determine whether it should remain as a Schedule I drug under the Controlled Substances Act, or be recommended for decontrol.

This is a single-dose, randomized, double-blind, placebo- and active-controlled crossover study that evaluates CBD in comparison with THC, alprazolam, and placebo in healthy recreational drug users.

Eligibility Criteria:
Inclusion Criteria:

* Must understand and provide written informed consent prior to the initiation of any protocol-specific procedures.
* Male or female subjects 18 to 55 years of age, inclusive.
* Body mass index (BMI) within the range of 19.0 to 30.0 kg/m2, inclusive, and a minimum weight of at least 50.0 kg.
* Healthy, as determined by no clinically significant medical history, physical examination,
* 12-lead ECG, vital signs or laboratory (including hematology, clinical chemistry biochemistry, urinalysis, and serology) findings at Screening, as judged by the investigator.
* Must be a recreational drug user, defined as meeting all of the following criteria:

  * ≥10 lifetime non-therapeutic experiences (i.e., for psychoactive effects) with CNS depressants (e.g., benzodiazepines, barbiturates, zolpidem, eszopiclone, propofol/fospropofol, gamma-hydroxy-butyrate).
  * ≥10 lifetime non-therapeutic experiences with cannabinoids (e.g., cannabis, hashish, THC, nabilone).
  * At least 3 non-therapeutic uses of a sedative, and at least 3 non-therapeutic uses of a cannabinoid, within the 3 months prior to Screening.
* Must pass Qualification Phase eligibility criteria.
* Female subjects of childbearing potential who are not abstinent must be using and willing to continue using medically acceptable contraception throughout the trial and for 30 days after last dose. In the context of this trial, highly effective methods of contraception are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include hormonal contraceptives, intrauterine devices/hormone-releasing systems, double-barrier methods, bilateral tubal occlusion, vasectomized partner, or sexual abstinence. Abstinence is only acceptable as true (total) abstinence, when this is in line with the preferred and usual lifestyle of the patient; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
* Non-vasectomized male subjects must agree to a highly effective method of contraception with female partner(s) of childbearing potential and may not donate sperm throughout the trial and for 90 days after the last study drug administration.
* Able to speak, read, and understand English sufficiently to allow completion of all study assessments.
* Must be willing and able to abide by all study requirements and restrictions.

Exclusion Criteria:

* contact site directly for more information
Developing and Testing Implementation Strategies for Evidence-Based Obesity Prevention in Childcare

Investigators will pilot test the impact of an enhanced implementation strategy on implementation and child health outcomes using continuous formative evaluation. Investigators will test the hypothesis that better fidelity to the implementation strategy (WISE) is positively related to child outcomes (e.g., child fruit and vegetable intake, BMI).

Investigators will determine whether the enhanced strategy is feasible, acceptable, and demonstrates improved implementation, fidelity, and sustainability using a Hybrid Type 3 implementation design. Investigators expect that the effectiveness of WISE on child outcomes will vary by the level of implementation fidelity, and a Hybrid 3 design allows for us to explore this hypothesis).

Eligibility Criteria:
Inclusion Criteria:

* Early childhood educators from our partnering Head Start agency

Exclusion Criteria:

* Secondary Outcome Inclusion Criteria:
* Children aged 3-5 years old in our partnering Head Start agency
Sequentially Combined Vitrectomy, IVTA and Macular Focal Laser Photocoagulation for Diabetic Macular Edema

Macular edema constitutes the primary cause of visual impairment in diabetic patients with a disease duration of 20 years or more. Intravitreal triamcinolone (IVTA) and macular focal laser photocoagulation were reported to generate favorable results in the treatment of diabetic macular edema, but there have been patients with diffuse diabetic macular edema refractory to such treatment modalities. The present study will test the safety and the efficacy of the combined treatment of vitrectomy, IVTA and macular focal laser photocoagulation in the treatment of intractable diffuse diabetic macular edema.

Fifty eyes from 50 diabetic patients were included, who had been diagnosed with intractable diffuse diabetic macular edema (DME). Intractable diffuse DME was defined as a biomicroscopically, angiographically and tomographically proven diffuse DME, which did not respond to or recurred after the previous intravitreal triamcinolone acetonide (IVTA) and/or macular focal laser photocoagulation. The central macular thickness (CMT) had to be greater than 250 μm. Preoperative ocular examination included best corrected visual acuity (BCVA) using the ETDRS chart, applanation tonometry, slit-lamp biomicroscopy, dilated fundus examination, optical coherence tomography (OCT) and fluorescein angiography. Pars plana vitrectomy with removal of retinal internal limiting membrane (ILM) was performed in all the 50 subject eyes. On the day after vitrectomy, triamcinolone acetonide (0.1 mL, 40 mg/mL) was injected intravitreally. Macular focal laser photocoagulation was performed 2 weeks after vitrectomy. As main outcome measures, BCVA was recorded and the CMT was measured using OCT by independent observers for all subjects at 3 and 6 months after the laser photocoagulation.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of diabetes mellitus
* intractable diffuse DME (diffuse DME which did not respond to or recurred after the previous IVTA and/or macular focal laser photocoagulation)
* the central macular thickness (CMT) greater than 250 μm

Exclusion Criteria:

* presence of vitreomacular traction
* a prior history of treatment for the DME within 3 months or vitreoretinal surgery
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder

The purpose of this study was to examine if group ear acupuncture improves Post-Traumatic Stress Disorder sleep difficulties among veterans who participated in Operations Enduring Freedom and Iraqi Freedom. This study also examined the degree of veteran acceptance for a group ear acupuncture procedure.

Background: Approximately 70-91% of veterans with Post-Traumatic Stress Disorder (PTSD) report insomnia. Presently, conventional treatments for PTSD-related insomnia include medications, psychotherapy, and cognitive behavioral therapy. While some of these conventional treatments do improve PTSD-related insomnia, many of these treatments have limitations (e.g., medication effects, lengthy time commitments, psycho-social stigma). Because of these limitations, many veterans are increasingly turning to complementary and alternative therapies to relieve their symptoms. There is a growing body of research that shows that acupuncture may improve many health symptoms including depression, PTSD, addiction, headaches, musculoskeletal pain, and insomnia. However, to date, no study has specifically explored how acupuncture may affect PTSD-related insomnia. Because so many veterans with PTSD experience PTSD-related insomnia, and because the current conflicts in Southwest Asia are producing a new generation of combat veterans, it is critical that the VA explore innovative treatments for PTSD-related health concerns.

Eligibility Criteria:
Inclusion Criteria:

1. Combat veteran of Operation Iraqi Freedom or Operation Enduring Freedom conflicts;
2. Diagnosed with Post Traumatic Stress Disorder (PTSD) per Diagnostic Statistical Manual (DSM) IV criteria;
3. Have insomnia as indicated by a score equal to or greater than 8 on the Insomnia Severity Index (ISI);
4. Diagnosis of insomnia made after PTSD diagnosis; and
5. If on psychotropic medications, must be on stable psychotropic medication regimen for one month prior to enrollment in study.

Exclusion Criteria:

1. Does not speak English;
2. Not competent to sign informed consent;
3. History of moderate or severe traumatic brain injury
4. Start use of Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) during the study.
5. Experiencing severe psychiatric illness defined as suicidal ideation, homicidal ideation, or psychosis;
6. History of substance abuse Dependence (as defined per DSM IV criteria) during the one year preceding enrollment in the study OR history of illicit substance use for 3 months prior to study enrollment OR positive Audit C score at study enrollment (defined as score of 5 and above).
7. Received acupuncture during past 3 months.
8. On Coumadin, Heparin, or Lovenox
9. Pregnancy
Controlled Trial of Prenatal Vitamin D3 Supplementation to Prevent Vitamin D Deficiency in Mothers and Their Infants

The purpose of this research study is to compare the effects of higher dose vitamin D with commonly recommended dose in pregnant women to see which is better in achieving and/or maintaining sufficient vitamin D blood levels during pregnancy and in newborn infants as well as improving growth in the infant.

Three dosages of Vitamin D will be administered; 400IU, 2000IU and 4000IU per day to pregnant women starting at less than 16 week gestation continued until delivery. The dose will be provided using a randomized control method. Serum levels of 25 hydroxy D will be measured in mothers at 12, 16, 28 and delivery. Cord blood 25 hydroxy D and the infants' birthweight, length and head circumference will be measured at birth.

Eligibility Criteria:
Inclusion Criteria:

* Women who are within the ages of 18-45 years
* In good general health
* 12 weeks pregnant (based on last menstrual period)

Exclusion Criteria:

* Mothers with preexisting type I or type II diabetes
* Mothers with preexisting hypertension
* Mothers with preexisting parathyroid disease or uncontrolled thyroid disease
* Mothers with multiple fetuses (e.g., twins, triplets, etc.)