cyrilzakka/clinical-trials huggingface dataset:
A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease

This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility, followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5/Study Exit). Safety will be assessed at all study visits.

At the end of the Screening Visit, all qualified subjects will be assigned to administer AR-15512 vehicle twice a day to both eyes for 14 days (vehicle run-in period). After the vehicle run-in period, subjects will be re-evaluated for signs and symptoms of Dry Eye Disease (DED). Subjects who requalify based on inclusion/exclusion criteria will be randomized in a 1:1:1 ratio to receive AR-15512 0.0014% (lower dose), AR-15512 0.003% (higher dose) or AR-15512 vehicle administered as 1 drop in each eye twice daily for 84 days.

This study will utilize a Controlled Adverse Environment (CAE) chamber, which serves to (1) minimize the factors that could impact the evaluation (temperature, humidity, and airflow) and (2) stress the ocular surface in a safe, standardized, controlled, and reproducible manner. Subjects will be exposed to the CAE for approximately 90 minutes during each CAE visit. Subjects will be exposed to the CAE at the Screening and Baseline visits as well as on Day 28 (Visit 4) and Day 84 (Visit 5). Efficacy endpoints will be evaluated pre- and post- exposure to the CAE.

Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.

Eligibility Criteria:
Key Inclusion Criteria:

* Previous history of dry eye disease (DED) within the previous 6 months;
* Have used and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit;
* Signs and symptoms of DED at the Screening and Baseline visits;
* Best Corrected Visual Acuity (BCVA) of 20/200 (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits;
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety;
* Current evidence of other significant ophthalmic diseases which, in the opinion of the investigator, may interfere with study findings or interpretation;
* Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study;
* Regular use of ocular medications or nutritional supplements as specified in the protocol within 30 days prior to the Screening visit;
* Positive pregnancy test at Screening or Baseline visits or currently breastfeeding.
* Other protocol-specified exclusion criteria may apply.
Music Therapy With Intubated and Sedated Pediatric Patients

The study is a randomized controlled trial of pediatric patients ages birth to two years of age who are mechanically ventilated and sedated as a result of a respiratory virus. The experimental group will receive twenty minutes of live, preferred music with a board-certified music therapist and the control group will receive twenty minutes of recorded music, also preferred, both interventions conducted at bedside. Caregivers will take a pre and post survey.

Data for heart rate, respiratory rate, and blood pressure will be taken for both control and experimental conditions prior to intervention, immediately following intervention, thirty minutes post, and sixty minutes post intervention. Caregivers will take the Parental Belief Scale for Hospitalized Children prior to intervention and 60 minutes poster intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients with respiratory syntactical virus, pneumonia, rhino, corona, bronchiolitis, or flu
* mechanically ventilated
* sedated
* Patients with underlying diagnosis accepted unless listed below
* Patients must have a primary caregiver present

Exclusion Criteria:

* Patients who are oscillating
* have a previous diagnosis of severe or profoundly deaf
* have a suspicion of child abuse
* in custody of the state.
: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery

To evaluate the pharmacokinetics of thromboprophylactic doses of LMWH enoxaparin in postoperative CABG patients, drug is administered either as a continuous intravenous infusion (CIV) or subcutaneous bolus (SCB) once per 72h. Plasma anti-Xa values are measured 12-14 times during study period and concentration maximums calculated to enable comparison of anti-Xa values between administration routes.

This is a prospective, randomized, controlled trial. After informed consent, 80 elective on pump CABG patients with a clinical indication for post-operative thromboprophylaxis will be studied in the Tampere University Heart Hospital. Study has two independent parts with 40 patients in both. Results are reported separately from these two parts of the study.

Firts part of the study: After written consent, 20+20 patients are randomized to receive enoxaparin either as continuous intravenous infusion (treatment group) or subcutaneous bolus injection (control group). Enoxaparin dose is 40mg/24h either CIV of SCB. Anti-Xa values are measured 12-14 times from blood samples to evaluate the anticoagulation effect of enoxaparin.

Second part of the study: After written consent, 20+20 patients are randomized to receive enoxaparin either as continuous intravenous infusion (treatment group) or subcutaneous bolus injection (control group). Enoxaparin dose is 1mg/kg/24h in CIV group and 0,5mg/kg twice a day in SCB group. In this second part of the study with eleveted enoxaparin dosage, 4 additional blood samples will be taken and analysed by ROTEM to investigate the overall coagulation status of the patients before and after the initiation of enoxaparin.

The study will consist of two independent parts.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18-33 kg/m2
* Elective on-pump CABG operation
* Indication for post-operative pharmacological thromboprophylaxis
* Written informed consent obtained from the patient or his/her legal representative.

Exclusion Criteria:

* Other indications for anticoagulant therapy than thromboprophylaxis
* Known heparin induced thrombocytopenia (HIT), or hypersensitivity to enoxaparin or heparin
* Any long-term anticoagulant medication, expect low-dose aspirin
* Major bleeding within the last week unless definitively treated
* Blood platelet count \<20, P-TT \<20 % or INR \>1.7
* GFR less than 30 ml/min/1.73 m2 estimated from serum creatinine by applying Cockcroft-Gault equation 13 or chronic dialysis
* Known HIV, HBV, or HCV infection
* Pregnancy
Collaboration Live

Collaboration Live is a prospective, single-arm clinical study of subjects who provide written consent. Subjects are scanned using a Philips EPIQ 5 or EPIQ 7 Ultrasound System equipped with Collaboration Live software. The study investigator will evaluate performance of the Collaboration Live tool with regard to performance of conferencing, sharing and control capabilities. Adverse events will be reported and the study investigator will assess potential relationship to the study device or study procedure. Additionally, the utility of Collaboration Live in remote consult of study patients will be evaluated. No patient follow-up beyond the initial consultation will be conducted with the Collaboration Live software solution.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Subject in indicated for a routine Obstetrics/Gynecology ultrasound examination at the site.
* Subject is willing and capable of providing informed consent and participating in this study

Exclusion Criteria:

* A medical condition or co-morbidity that would be unduly affected by study participation, per investigator discretion
Kinesiotape and Core Exercises in Federated Boxers

Introduction. Nonspecific lumbar pain is a very common cause of sports decline in boxers, possibly due to the repetitive movements of flexion and rotation in their sport, so the investigators believe it is interesting to seek an intervention that helps these athletes to reduce their incidence.

Aim. To improve non-specific low back pain, range of motion of trunk flexion; the muscular resistance of the spinal erectors and the subjective perception of the effort in federated boxers older than 18 years.

Study design. Randomized, multicentric and double-blind clinical trial with follow-up period.

Methods. 60 federated boxers of legal age will be recruited, who will be randomly assigned to the study groups: experimental (Core and Kinesiotape® exercises) and control (Core exercises and Kinesiotape® tubes without tension). The intervention will last 4 weeks, with 2 weekly sessions, lasting 35 minutes. Three evaluations will be carried out (pre-treatment, post-treatment and follow-up) for the dependent variables. The analysis of normality will be carried out with the Kolmogorov Smirnov test and in case of homogeneity of the sample, with the t-student test of related samples and the ANOVA of repeated means, the difference between the evaluations and the intra e effect will be calculated. intersubject, respectively.

Expected results. It is expected to observe the effectiveness of the Core and Kinesiotape® exercises in the perception of nonspecific lumbar pain, the range of movement of trunk flexion and lumbar resistance, and the perception of effort.


Eligibility Criteria:
Inclusion Criteria:

* Federated boxers
* Over 18 years
* Male
* With non-specific back pain that does not incapacitate them for the realization of their sport or work activity.

Exclusion Criteria:

* Federated boxers with lumbar injury with medical diagnosis
* Who are or have been treated by pharmacological or physiotherapy in the last 6 months
* Presenting allergies or alterations of the skin
* Not sign the informed consent document.
Clinical Evaluation of Investigational Multifocal Toric Contact Lenses

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

This non-dispensing study is to evaluate the clinical performance of a test multifocal toric silicone hydrogel contact lens compared to a marketed multifocal toric contact lens (control).

Eligibility Criteria:
Inclusion Criteria:

* Has had a self-reported oculo-visual examination in the last two years.
* Is aged 40-75 years, inclusive and has full legal capacity to volunteer.
* Has read and understood the participant information sheet.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is able to participate in Parts A and B related to this work.
* Has a contact lens spherical prescription between +10.00 to -10.00D (inclusive).
* Has an Add component to their spectacle refraction (between +0.75 and +2.50DS).
* Has astigmatism between -0.75 and -5.75DC (based on the vertexed ocular refraction in each eye.
* Can be satisfactorily fitted with the study lenses.
* Is correctable to a visual acuity of 20/40 (0.30 logMAR) or better (in each eye) with their habitual vision correction or 20/25 (0.10 logMAR) best-corrected.
* They have successfully worn soft contact lenses in the last six months
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination.
* Has an up-to-date pair of spectacles.

Exclusion Criteria:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would, in the opinion of the investigator, affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye that would, in the opinion of the investigator, be problematic for their participation in the study.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has undergone corneal refractive surgery.
* Has a history of anaphylaxis or severe allergic reaction.
* Has diabetes or an infectious or immunosuppressive disease which could contraindicate contact lens wear or pose a risk to the investigator.
* They are pregnant or breast-feeding.
* Is participating in any other type of eye-related clinical or research study.
Early Detection of Cognitive Dysfunction in Diabetes

The rate of cognitive decline due to ageing is increased 1.5-fold to 2.0-fold in individuals with type 2 diabetes.There are no established specific treatment measures to prevent or ameliorate cognitive impairments in patients with diabetes. we want to detecte early clinical dementia in diabete.

Clinically relevant cognitive decrements in relation to diabetes mainly occur during two crucial periods in life: the period of brain development in childhood, and the period when the brain undergoes neurodegenerative changes associated with ageing.Potential leads for treatment are to optimise glycaemic control and avoid and treat vascular risk factors.we want to detecte early clinical dementia in diabete by MMSE and Olfactory function.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes(Age\>50 years)

Exclusion Criteria:

* with stroke or other complications.
A Comprehensive Peer Mentor-based Disease Management Program for Medically Complex Substance Users

Substance-using adults are admitted to hospital for medical complication from their drug and alcohol use at very high rates; yet, their care is often defined by low rates of referral to addiction treatment programs and recidivism. In 1997, we instituted an integrated medical-substance use treatment program at Johns Hopkins, the First Step Day Hospital, designed for intensive post-acute care of previously hospitalized substance using adults. We have shown that patients with dual diagnoses admitted to First Step more often complete their course of medical care and stay in recovery longer than patients not admitted to First Step.(1;2) On discharge from First Step, patients are medically stable and drug-free. Their substance abuse care is transferred to an out-patient substance abuse treatment facility and their medical care is transferred to their primary care provider. Unfortunately, many patients are lost to follow-up during this transition. We believe that a peer mentor-based disease management program (PM) can provide continuity of care that begins in First Step and continues after discharge thereby increasing the proportion of patients who remain in treatment for their addiction and medical conditions. Peer mentors are persons from the target community who have been in recovery for 5 or more years. In cooperation with patients and providers, peer mentors improve the integration of care, quality of care, and access to healthcare services. This pilot study will test the effectiveness of a peer mentor-based disease management program. The specific aims are to compare the impact of the PM intervention verses enhanced usual care on outcomes in three domains (1) medical/psychiatric health status, (2) addiction recovery, and (3) social resource acquisition. If successful, this study will provide evidence supporting a larger randomized controlled trial of the impact of field workers on post-acute care among patients with dual diagnoses.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to an intensive day hospital focused on medically complex substanse users are eligible for enrolment

Exclusion Criteria:

* Inability to provide informed consent
Evaluation of Snakebite Cases in Assiut Governorate, Egypt (Prospective Study)

1. Study the sociodemographic profile of snakebite victims in Assiut Governorate.
2. Portray the clinical profile of snakebite victims admitted to Assiut University , El Eman General Hospital and Assiut General Hospital.
3. Assess the predictors of severity and outcome of cases.

Snake's envenomation is a serious socio-medical problem, which causes considerable mortality and morbidity, with approximately 125,000 deaths worldwide annually. There were 4.5 to 5.4 million bites every year, and of those figures, 40-50% had some clinical disability as a result. Furthermore, the death from such an issue could go somewhere between 80,000 and 130,000 individuals each year. In the Middle East and North Africa, there are over 70,000 snakebites bites each year.

There are many species of snakes, approximately 3,700 species of snakes worldwide only about 15% are venomous belong to the four large families including Viperidae, Colubridae, Elapidae and Atractaspidinae. Two of these toxic species are widespread in Egypt; the family Viperidae and the family Elapidae Egyptian copra Naja Haje.

Snake venoms are complex mixtures consisting of enzymatic components e.g., proteolytic enzymes e.g., serine protease and metalloproteases (SVMPs), non-enzymatic components e.g., cysteine-rich secretory proteins (CRISP), amines, lipids, nucleotides, and carbohydrates. Venoms also contain inorganic cations that are presumed to function as cofactors and include sodium, calcium, potassium, magnesium, and zinc.

Snake venoms are usually classified as hemotoxic or neurotoxic. Snakes of the Viperidae family have venom containing proteins that can disrupt the coagulation cascade, the hemostatic system and tissue integrity. In contrast, neurotoxic venoms, which are typical of the Elapidae snakes, contain several toxins that primarily affect the peripheral nervous system, in particular the neuromuscular junction.

Depending on the species of snakes, manifestations can be localized symptoms of mild pain, progressive edema, ecchymosis, and tissue necrosis and generalized ones as spontaneous bleeding e.g., bleeding per gums, epistaxis, hematuria, vaginal bleeding, hematemesis, hematochezia, hemoptysis, hemolytic anemia and hemolytic jaundice with hemototoxic snake venom. In severe cases patients may develop acute renal, myocardial infarction, disseminated intravascular coagulation, or even death. Ptosis, diplopia, dysphagia, trunk and limbs weakness, and respiratory paralysis which can lead to respiratory failure and apnea with neurotoxic snake venom.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted with a reliable history of snakebite.
* Presence of fang marks and/or signs of local and systemic envenomation.

Exclusion Criteria:

* Fake or uncertain snakebites.
* Patients with history of hematological disorders, liver diseases, renal diseases and anticoagulation therapy in the past week.
* Patients who are not willing to participate in the study.
Electronic Intervention for HIV Medication Adherence

The purpose of this study is to develop and examine the feasibility and initial efficacy of a computer-based intervention to improve medication adherence among people living with HIV.


Eligibility Criteria:
Inclusion Criteria:

* infected with HIV
* over age 18
* currently prescribed a Highly Active Antiretroviral Therapy (HAART) regimen
* prescribed a regimen for the first time, changing regimens, or report adherence below 95% agree to brief follow-up interviews

Exclusion Criteria:

* physical impairment that would prevent them from successfully completing the computer-based program (e.g., blind, deaf, severe neuropsychological impairment)
* Actively psychotic
* Not fluent in English
Changes of Soft Tissue Grafting: A Randomized Study

To correct gum recession, patient's own tissue from the roof of the mouth is harvested and placed where there is root exposed. This is considered gold standard of treatment. Sometimes patient don't want to have second surgical site in their mouth and at the same time do not want to use alternative tissue from human or animal donor. Using patients' blood and preparing it as a membrane is the next best thing to correct gum recession.

Patients that are interested in having corrective surgery for recession due to esthetic concerns or sensitivity will be enrolled in the study. The treatment site will randomly receive the procedure assignment. Intraoral scanner will be utilized to establish pre-op volume and will be repeated at each follow up visit. Total of 12 visits and 5 year duration is anticipated for the study.

Eligibility Criteria:
Inclusion Criteria:

1. Adults 18yrs or older
2. Need of MG-tx for 2 or more sites for root coverage RT I and II (Cairo classification)
3. Class A +/-
4. No class V restoration present

Exclusion Criteria:

1. Patients who do not consent to recommended therapy
2. Patients who smoke
3. Patients who will not be able to comply with follow up protocols
4. Those who self report that they are pregnant.
WeChat Intervention for Smartphone Addiction in College Students: a Randomized Trial

The goal of this clinical trial is to assess the effectiveness of an intervention based on the Information-Motivation-Behavioral Skills (IMB) model to treat smartphone addiction in college students. The main questions it aims to answer are:

Does the IMB model-based intervention via WeChat public accounts significantly reduce smartphone addiction scores compared to a control group? Does the intervention lead to an increase in motivation and behavioral skills scores among participants? Researchers will compare the intervention group, which receives IMB-enhanced content through WeChat public accounts, to the control group, which maintains regular activities, to see if there are significant improvements in addiction scores, motivation, and behavioral skills in the intervention group.

Participants will:

Be stratified by gender and randomly assigned to either the intervention or control group.

The intervention group will receive information, motivation, and behavioral skills enhancement via WeChat public accounts over a period of 6 weeks.

Both groups will be assessed for smartphone addiction scores, information-motivation-behavioral skills scores, average daily smartphone use time, sleep duration, sleep quality, and somatic and psychological symptoms before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

Meeting the criteria of the Smartphone Addiction Scale-Short Version (SAS-SV), with a score of ≥31 for males and ≥33 for females indicating smartphone addiction.

College students over 18 years old. Active use of WeChat software. Voluntary participation in this study and signing of the informed consent form.

Exclusion Criteria:

Currently not enrolled in school due to reasons such as suspension. Currently participating in other research projects. Self-reported diagnosis of any neurological or psychiatric disorder.