cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.


Eligibility Criteria:
Inclusion Criteria:

* · Males or females \> 18 years old

  * Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
  * Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

* · Patients using Restasis® for less than 3 months.

  * Known contraindications to any study medication or ingredients
  * Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
  * Other active uncontrolled ocular diseases or uncontrolled systemic disease
Inflammatory Cytokines in Congenital Cataract After Lensectomy and Anterior Vitrectomy

In this prospective study , a cohort of 58 eyes with congenital cataract from Wenzhou medical university was erolled.33 eyes with congenital cataract was after lensectomy and anterior vitrectomy as post-surger group, 26 eyes without cataract surgery as control group. The cytokines of MCP-1, VEGF, IL-1, IFN-γ, IL-1r,IL-4,IL-17, IL-2,IL-5,G-CSF,IL-12, IL-15 was evaluated

Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and primary IOL implantation in children with congenital cataract were both performed by the same surgeon(Z.Y.E) and videos were collected to review the capsular reconstruction condition and lens implantation position.

Aqueous humor (100-200 μl) was aspirated from each patient before the surgery. The research was to evaluate the relationship between the cytokine profile in aqueous humor and the state of capsule after Lensectomy and Anterior Vitrectomy.Aqueous humor was obtained , Human Magnetic Luminex Screening Assay was used to determine the aqueous humor levels of cytokines.

Eligibility Criteria:
Inclusion Criteria: aphakic children diagnosed with congenital cataract who underwent secondary IOL implantation and children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation

Exclusion Criteria:patients with mild cataracts do not require surgery

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Personality Bleaching

128 patients between 18 and 76 years who attended the Operative Dentistry Clinic at Dental School, Universidad de Chile, were included in the study. 58 patients were bleaching (experimental group) and 70 patients don't accepted the bleaching procedure (control group) were included in this study and signed a consent form.Experimental group Patients who agreed to be bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject With verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications , before and after this procedure was applied again the NEO-FFI personality test form, had 30 minutes to answer it.Control group:Patients who refused to be bleached were administered the personality test NEO-FFI, had 30 minutes to answer it.

Data collection NEO-FFI data was collected in a Microsoft Excel data sheet and analyzed by a psychology that was blind to patient's expectations. According to the answers, each scale might get a score between 0 and 50.

Statistical analysis For comparisons between scales between groups of patients were bleaching and who refused to be bleached Mann Whitney test was used.For each pair of scales it was determined if any one of them predominated over its counterpart by Wilcoxon rank test before and after bleaching . To corroborate the statistical power of this study was calculated post-hoc with the NEO-FFI scores values between the comparisons and showed a high statistical power (0.99) by G-Power software.

Eligibility Criteria:
Inclusion Criteria:

* Participants included in this clinical trial were between 18 and 76 years old and had good general and oral health. Each subject had at least one central incisor with shade A2 or darker, assessed by comparison with a value-oriented shade guide (Vita classical, Vita Zahnfabrik, Bad Säckingen, Germany)

Exclusion Criteria:

* Participants that had undergone previous dental bleaching procedures during orthodontic treatment, or those that were pregnant or lactating women and participants with bruxism habits, were not included in the trial. Additionally, participants with restorations on the labial surfaces of their anterior teeth and non-carious cervical lesions, veneers or full crowns, with gingival recession, spontaneous tooth pain, internal tooth discoloration, and teeth with endodontic treatment or fluorosis were also excluded from this trial
The Effect of The Mindfulness-based Childbirth and Parenting Program

The aim of this study is to determine the effect of Mindfulness-based childbirth and parenting program on prenatal attachment and depression, stress and anxiety levels of pregnants.

The study will be carried out in two different groups. After the pregnants are evaluated in terms of eligibility criteria for the research, the pregnants who are eligible will be informed about the research and written informed consent will be obtained from the pregnants who accept. The random distribution of pregnants to the study groups will be carried out random. The following applications will be made to the groups.


Eligibility Criteria:
Inclusion Criteria:

* Being at 20-30 weeks of gestation
* Being nulliparous

Exclusion Criteria:

* History of psychiatric illness
* Follow-up in the risky pregnancy clinic
* Not completing the study
Cardiac Rhythm and Affecting Factors in Patients Hospitalized in the Physical Therapy and Rehabilitation Clinic

In our study, it is aimed to evaluate the cardiac rhythms of patients who are decided to receive inpatient treatment in the physical therapy and rehabilitation clinic due to any neuromusculoskeletal diseases with 24 hour rhythm holter follow up on the day of hospitalization and three weeks after hospitalization and to determine the factors that may affect this result if a significant change is observed between the two measurements.The present results will guide the determination of the exercise duration, intensity, type and severity of the exercises to be created within the scope of the treatment programs of the patients and will lead to similar studies.

Neuromusculoskeletal disorders include a variety of fairly common pathologies that can have a major impact on a person's health. Today, neuromusculoskeletal diseases are the main causes of occupational diseases and chronic physical disability leading to high health care costs globally. Exercise therapy is seen as an important part of the treatment of many neuromusculoskeletal diseases.

Patients hospitalized in the physical therapy and rehabilitation clinic are generally elderly people with chronic neuromusculoskeletal system disorders. While the presence of ventricular premature beat is detected in more than 50% of healthy adults in 24 hour rhythm holter examination, this rate rises above 90% in the elderly.Although many studies have noted that regular exercise and high cardiovascular fitness reduce the risk of cardiovascular arrhythmias, exercise may paradoxically increase the risk of sudden cardiac death in those with preexisting cardiac abnormalities.

There are no studies evaluating the changes in heart rhythms during hospitalization of patients hospitalized for treatment in physical therapy and rehabilitation clinics where exercise therapy is frequently applied.In our study, it is aimed to evaluate the cardiac rhythms of patients who receive inpatient treatment in the physical therapy and rehabilitation clinic with 24 hour rhythm holter follow up on the day of hospitalization and three weeks after hospitalization and to determine the factors that may affect this result if a significant change is observed between the two measurements.

Eligibility Criteria:
Inclusion Criteria:

* Be over 18 years old
* To be evaluated for any neuromusculoskeletal system disease and decided to be treated as an inpatient in the physical therapy and rehabilitation clinic
* Having agreed to participate in the study

Exclusion Criteria:

* A change in medication that may affect cardiac rhythm in the last two weeks
Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy

This study is to compare polyethylene glycol and sodium phosphate for colonic cleansing of colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients meet the following criteria: 1) age 18-60 years; 2) BMI 18.9-28; 3) Heart, lung, liver, and kidney function can tolerate colonoscopy; 4) Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent

Exclusion Criteria:

* 1) colorectal surgery history (except appendectomy); 2) patients with intestinal obstruction, incomplete obstruction, intestinal hemorrhage; 3) patients with renal insufficiency; 4) patients with hirschsprung disease; 5) patients with inflammatory bowel disease during active period, which affects intestinal observation; 6) patients who are bedridden and lose the moving ability ; 7) have a history of severe mental illness; 8) pregnant or lactating women; 9) patients with other clinical conditions considered by some researchers should not participate in the trial.
Community Health Workers and Prevention of Mother-to-Child HIV Transmission in Tanzania

The investigators implemented and evaluated a pilot program in Shinyanga Region, Tanzania to bring prevention of HIV services to communities using community health workers (CHWs). The intervention aimed to integrate community-based maternal and child health services with HIV prevention, treatment, and care-bridging the gap between women and facility, and enhancing the potential benefits of Option B+. Option B+ is the current World Health Organization recommendation for prevention of mother-to-child transmission, but its success in sub-Saharan Africa may be threatened by overburdened clinics and staff. Consequently, paraprofessionals like CHWs can be key partners in the delivery and/or enhancement of health services in the community.

The study focuses on whether this approach: increases retention in care; improves adherence to antiretrovirals (ARVs); or improves the number of women initiating antiretroviral therapy and the timing of initiation. Investigators hypothesize improvements along primary and secondary outcome indicators in the treatment group. This evaluation helps illuminate both the impact and feasibility of the intervention, and the role that CHWs may play in the elimination of mother-to-child transmission services.


Eligibility Criteria:
Inclusion Criteria:

* Women who were identified in one of the medical registers used for sampling at the facility, were HIV-positive, and had a child born in either the baseline or endline cohort time windows (January and December 2014 or April and October 2015).

Exclusion Criteria:

* Did not have sufficient information to link them across registers
Feasibility of Telesurveillance and Home Cough Assistance for Amyotrophic Lateral Patients (ALS)

The investigators want to test feasibility of a structured program of telesurveillance and home cough assistance for ALS patients.

Background: Amyotrophic Lateral Sclerosis (ALS) patients present reduction in the inspiratory and expiratory muscle strength, frequent secretions increase, insufficient expectoration ability with inevitable risk of acute respiratory failure (ARF) and necessity of hospitalizations. Recently, new mechanical tools (In-Exoflator EmersonR) are available in our hospital to help patients to expectorate during ARF. It is well noted these patients are particularly reluctant to be hospitalized to avoid further worsening in their quality of life.

Aim: the investigators want to test feasibility of a structured program of telesurveillance and home cough assistance for ALS patients.

Methods: A telesurveillance program (TP), a pulsed saturimetric device, 2 hours educational hospital sections (air stacking with Ambu balloon, manual manoeuvres and In-Exoflator indications and use) will be offered to all ALS consecutive patients.

In details the TP is structured as follows: 1) Domiciliary Telesurveillance by only one 24-h Service Centre (SC) for enrolled pts with ALS in hospital discharge phase, 2) Patients - taken care of five days/week by a nurse-tutor (NT) and respiratory therapist (RT) according to a predefined appointments, 3) for 24-hr. duration (in case of symptoms) patients can call SC and talk to pneumologists that can intervene whenever needed for diagnostic-therapeutic adjustments. 4) In case of need the patient can contact the neurologist or psychologist; 5) The RT in accordance with pneumologist can decide for a domiciliary visit to patient.

Home RT accesses and In-Exoflator activation will be prescribed when patients will present worsening of three points in pSaTO2, 30% in peak cough expiratory flow (PCEF), lack of cough ability with increase in secretions and or suctions necessity (in tracheotomy patients) and clinical symptoms (dyspnoea, fever, headache, somnolence).

Number of In-Ex and air stacking activations, ARF episodes, hospital accesses, antibiotic therapy, customer satisfaction, PCF/PEF, MIC-VC, respiratory function (MIP, MEP, FEV1, FVC, FEV1/FVC, ABG), dyspnoea (Borg scale), general disability (Hoevelaken scale and ALS Functional Rating Scale) and survival will be collected.

Expected results: 30 ALS patients (VC \< 80% and 40% with tracheotomy) will be enrolled after discharge from Respiratory or Neurological units of S. Maugeri Foundation. This study will allow:

1. To test a possible alternative of care for ALS patients
2. To check patients and caregivers' acceptance
3. To measure time consuming for care team
4. To quantify patient's comfort
5. To test costs/effectiveness ratio.

Eligibility Criteria:
Inclusion criteria:

* 40 ALS patients (VC \< 80% with or without tracheostomy)will be enrolled after discharge from Respiratory or Neurological units of S. Maugeri Foundation.

Exclusion Criteria:

* None
Enteral Feeding Composition and Acute Respiratory Failure

This study aimed to investigate the effect of enteral feeding's macronutrient composition on inflammatory mediators, oxidative stress and outcomes in Intensive Care Unit (ICU) patients with acute respiratory failure. In this double-blind randomized control trial, 42 patients of both sexes and diagnosed with acute respiratory failure in ICU that receive enteral feeding, will be randomly assigned to three groups of 14 each. First Intervention group; high-protein low-carbohydrate diet with high olive oil, the second intervention group; high-protein low-carbohydrate diet with high sunflower oil and control; high-protein kitchen formula. Intravenous levels of uric acid, high sensitive C-Reactive Protein (hs-CRP), Interleukin 6 (IL-6) and Total Antioxidant Capacity (TAC) measured at days 0 and 10. As well as, organ failure, duration of ventilation, length of ICU stay and mortality rates will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in ICU
* age older than 18 years old
* need to be mechanically ventilation
* have enteral feeding
* no previous diabetes
* no previous HIV infection
* no previous nervous system
* no previous liver failure
* no previous nephrotic syndrome
* not passed more than 48 hours from diagnose of acute respiratory failure

Exclusion Criteria:

* death at less than three days of enteral feeding administration
* extubation at less than three days of enteral feeding administration
Study to Assess Function and Satisfaction of Oral Ubrogepant in Adult Participants After Multiple Migraine Attacks In Canada

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate function and satisfaction with oral ubrogepant in treating adult participants after multiple migraine attacks.

Ubrogepant is a drug approved for the acute treatment of migraine in adults. Approximately 167 participants will be enrolled in approximately 10-15 sites across Canada.

Participants will receive ubrogepant as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 12 weeks.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants able to give voluntary informed consent before starting any study-related assessments or procedures (to be obtained/documented as per local regulations).
* Adults (≥18 years of age) at time of informed consent.
* Participants with at least 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3 (2018).
* Participants with history of experiencing at least 3 migraine attacks per month with moderate to severe symptoms
* Participants prescribed ubrogepant by investigator for the acute treatment of migraine according to local product label, independent of and prior to study participation
* Participants willing and able to comply with the requirements of the study.
* Participants with access to an electronic device (mobile phone, tablet, laptop, etc.) with internet access.

Exclusion Criteria:

* Participants previously exposed to a ubrogepant or rimegepant as routine therapy or through a clinical trial.
* Participants with history of known contraindications to ubrogepant as per local labeling.
* Participants Pregnant or planning to be pregnant or of childbearing potential not using contraception
* Participants enrolled in any interventional studies that may include investigational compounds for migraine or non-AbbVie observational studies.
* History or current evidence of any condition that might interfere with their ability to comply with the study requirements, in the opinion of the investigator.
Expanded Access Program for RP in Adults

This intermediate-size patient population expanded access program is to provide access to investigational product OCU400 for up to 75 patients with Retinitis Pigmentosa (RP) outside of the ongoing clinical trial Phase 3 program for patients who do not have access to alternative Food and Drug Administration (FDA)-approved products for treatment of the disease.

This expanded access protocol provides access to OCU400 for a subset of patients. Subjects will undergo specific ocular testing included in the study. Subjects will follow-up with physical examination, review of concomitant medication, blood work and ocular examinations for up to 52 weeks (about 12 months) post dosing.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females ≥18 years of age at the time of informed consent.
2. Confirmed clinical and CLIA certified genetic diagnosis of RP (except subjects with AD-NR2E3 mutation)
3. Presence of photoreceptors as determined by spectral-domain optical coherence tomography (SD-OCT).

Exclusion Criteria:

1. Subject lacks evidence of outer nuclear layer, i.e., containing the nuclei of the retinal photoreceptors as determined by SD- OCT.
2. Considered unsuitable for any reason that may either place the subject at increased risk during participation or interfere with the interpretation of the study outcomes by the Investigator, or the Sponsor after reviewing the subject medical history and condition.
3. Previous treatment with a gene-therapy or cell therapy product, excluding OCU400.
4. Previous treatment with any investigational drug or device within one year, excluding OCU400.
5. Any contraindications for subretinal injection.
6. Cataract surgery within 3 months. YAG capsulotomy within 1 month. Any other intraocular surgery within 6 months
Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University Hospital

One centre follow-up study on safety and efficacy of treatment with rituximab among patients with RA during 4 year period. Basic data is collected for the national register of biologicals.

Data is collected on regular visits in the outpatient department. In collection national register forms have been used.

Eligibility Criteria:
Inclusion Criteria:

* active RA without response to earlier treatment

Exclusion Criteria:

* contraindications to rituximab
Using Immersive Virtual Reality to Treat Pediatric Anxiety

Anxiety is a common and impairing problem for children. The principle treatment for pediatric anxiety involves facing a child's fears in a stepwise approach through a therapeutic exercise called exposures. While exposures are effective, some feared situations cannot be confronted in a clinician's office (e.g., heights, public speaking, storms). This poses a logistical challenge in treatment that: (1) takes time away from patient care, (2) leads clinicians to rely on imagined exposures, and/or (3) requires families to complete exposures outside of the therapy visits. This creates a burden for clinicians and families, and impedes treatment success. Immersive virtual reality (VR) presents an innovative solution that allows children to face fears without leaving the clinician's office. While VR has been used to distract children during painful medical procedures, it has not been well examined as a primary treatment for pediatric anxiety. This study proposes to examine the effectiveness and acceptability of using immersive VR exposures to treat children and adolescents with specific phobias.


Eligibility Criteria:
Inclusion Criteria:

* 8-17 years (inclusive),
* meet diagnostic criteria for one or more phobias on a structured diagnostic interview (ADIS-C/P). This specifically includes natural environments (e.g., storms, heights) and/or situational settings (e.g., airplanes, public speaking).
* be fluent in English.

Exclusion Criteria:

* unable to complete rating scales, or
* attend study visits.
Bioequivalence of Imeglimin Tablet Formulations

This is an open-label assessment of the bioequivalence of two 500 mg-tablet formulations of imeglimin (Tablet A \[reference product\] and Tablet B \[test product\]), in at least 16 healthy Caucasian volunteers.


Eligibility Criteria:
Inclusion Criteria:

* BMI : 18.5-29.9
* Body weight ≥ 60 kg
* willing to use reliable contraception
* able to give fully informed written consent.

Exclusion Criteria:

* Positive tests for hepatitis B \& C, HIV
* severe adverse reaction to any drug; sensitivity to trial medication and/or food allergies
* drug or alcohol abuse
* smoking of more than 5 cigarettes daily or drinking more than 5 cups of caffeinated drinks daily
* over-the-counter medication, vitamins and herbal remedies, or prescribed medication in the 20 days before the first dose of trial medication (with the exception of paracetamol \[acetaminophen\] and oral contraception);
* participation in other clinical trials of unlicensed medicines, or loss of more than 400 mL blood, within the previous 3 months
* vital signs outside the acceptable range
* clinically relevant abnormal findings at the screening assessment; estimated glomerular filtration rate (eGFR) at screening \< 80 mL/min/1.73 m2
* acute or chronic illness
* clinically relevant abnormal medical history or concurrent medical condition;
* surgery or medical condition that might affect the absorption of medicines;
* possibility that volunteer will not cooperate
* pre-menopausal females who are pregnant or lactating, or who are sexually active and not using a reliable method of contraception;
* objection by the volunteer's General Practitioner (GP).