cyrilzakka/clinical-trials huggingface dataset:
A Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses

The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.

This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.

Eligibility Criteria:
Inclusion Criteria:

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

* Has had a self-reported oculo-visual examination in the last two years
* Is 50 years of age or greater and has full legal capacity to volunteer
* Is able to read and understand the informed consent
* Is willing and able to follow instructions and maintain the appointment schedule
* Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
* Near Add Power requirement of +2.25D or greater
* Has spectacle cylinder 0.75 D in both eyes
* Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
* Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
* Has clear corneas and no active ocular disease
* Has not worn gas permeable contact lenses for 1 month prior to the study

Exclusion Criteria:

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

* 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 abnormality that would affect the wearing of contact lenses
* Is aphakic (i.e. missing their natural lens inside their eye)
* Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study.
A Phase 3 Study Comparing Dinaciclib Versus Ofatumumab in Patients With Refractory Chronic Lymphocytic Leukemia (P07714)

This study is being conducted to demonstrate the superiority in progression-free survival (PFS) of dinaciclib compared to ofatumumab in chronic lymphocytic leukemia (CLL) participants with del 17p or in the overall population who are refractory to either fludarabine treatment or chemoimmunotherapy.

Dinaciclib is a cyclin-dependent kinase (CDK) inhibitor, specific for CDK 1, 2, 5 and 9.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL)
* Fludarabine or chemoimmunotherapy refractory disease defined as: failing to respond to or relapsed within 6 months of completing fludarabine or another purine analog alone or in combination regimens, or failing to respond to chemoimmunotherapy or relapsed within 24 months of completing therapy with a combination of chemotherapy plus an anti-CD20 monoclonal antibody
* Eastern Cooperative Oncology Group (ECOG) Performance status 0, 1, or 2
* Adequate organ function and laboratory parameters
* Women of child-bearing potential who are not currently sexually active must

agree to use a medically accepted method of contraception should they become

sexually active while participating in the study

Exclusion Criteria:

* Symptomatic brain metastases or primary central nervous system malignancy
* Treatment with a CYP3A4 inhibitor or inducer within 1 week prior to randomization, or any chemotherapy or biologic therapy within 4 weeks prior to randomization
* Known human immunodeficiency virus (HIV) infection or a known HIV-related

malignancy

* Participants with with clinically active hepatitis B or C defined as disease that requires therapy
* Positive test for glucose-6 phosphate dehydrogenase (G6PD) deficiency
* Prior allogeneic bone marrow transplant
* Presence of Richter's transformation
* Indeterminate deletion 17p status
* Previous treatment with ofatumumab, dinaciclib, or other CDK inhibitors
* Active autoimmune anemia or thrombocytopenia unless stable, which is defined as being responsive to corticosteroids or other standard therapy
A Pharmacokinetic and Pharmacodynamic Study of Phenoxymethylpenicillin for Children

The aim of this trial is to evaluate the pharmacokinetics and pharmacodynamics of penicillin V in non-infectious children to estimate the optimum dosage regime in children.

Although occasionally questioned, the efficacy of penicillin in eradication of respiratory tract infections in children has not been convincingly reported in the literature. Two randomized multicenter antibiotic efficacy trials have been reported in eradication of group A streptococci where both oral and intramuscular administration of penicillin had relatively high microbiologic failure rates. But the trials only confirm that the treatment is not effective in the given dose. The recent recommendations on penicillin are unfortunately based upon past practices, clinical trial results and recent resistance trends and pharmacodynamics have not been considered to support the choice of drug and dosage regimen. Some pharmacodynamic trials have been made on meropenem, cefotaxime, piperacillin-tazobactam and amoxicillin in children but so fare no trials have been described on penicillin. It is well described in adults but the absorption and secretion might be depended on age. Penicillin exhibit a time-dependent killing which means that the time over minimal inhibitory concentration (MIC) is the parameter best related to efficacy.

Methods:

The investigators evaluate the pharmacokinetics and pharmacodynamics of penicillin V in non-infectious Danish children at age 0-10 years who were admitted for a chromium-51-EDTA-clearance test. The investigators excluded children with allergy to penicillin and children with a prior known reduced glomerular filtration rate. The parents of each child who participated gave written informed consent before the study and ethical approval was obtained.

Antimicrobial dosage and administration:

40 children were assigned to receive per oral penicillin suspension 22-32 mg/kg. The dosage was estimated 25 mg/kg by the weight the parents rapported and they had a weight control at admission. The exact given dose was then calculated. The penicillin were not taken on an empty stomach to imitate reality as much as possible and the time of administration was noted. Another 40 children were given 50 mg/kg penicillin mixture.

Samples:

Blod samples of 1 ml were taken after 0, 15, 30, 60, 90, 120 minutes after the Crom-EDTA examination had started giving a dispersion in time compared to the intake of penicillin. The samples were collected in vacuum tubes containing EDTA as an anticoagulant and then centrifuged quickly. The separated serum were placed in cryovials before frozen.

Eligibility Criteria:
Inclusion Criteria:

* Non-infectious Danish children at age 0-10 years who were admitted for a chromium51EDTA clearance test

Exclusion Criteria:

* Children with allergy to penicillin and children with a prior known reduced glomerular filtration rate
ALFAsleep: Exploring Cognitive and Biological Correlates of Sleep Quality and Their Potential Links With Alzheimer's Disease

The main goal of this study is to perform a multimodal characterization of brain structural and functional changes, as well as changes in Alzheimer's disease (AD) biomarkers, as a function of sleep quality measures. Cross-sectional data will enable us to confirm and expand previous knowledge in a large and well-phenotyped population, while longitudinal data will allow us to test the hypothesis of the existence of a bidirectional relationship between sleep quality and AD.

The main goal of this study is to perform a multimodal characterization of brain structural and functional changes, as well as changes in Alzheimer's disease (AD) biomarkers, as a function of sleep quality measures. Cross-sectional data will enable us to confirm and expand previous knowledge in a large and well-phenotyped population, while longitudinal data will allow us to test the hypothesis of the existence of a bidirectional relationship between sleep quality and AD.

Eligibility Criteria:
Inclusion Criteria:

* Subjects that are currently participating in the ALFA+ study (cognitively healthy adults aged between 45-65 years at the moment of the inclusion in the 45-65/FPM2012 study).
* Subjects from whom CSF and/or neuroimaging biomarkers have been acquired during the last 36 months prior to their enrollment in the current study.

Exclusion Criteria:

* Presence of cognitive impairment.
* Presence of clinically relevant neurological disorder, psychiatric disorder or other medical conditions that may jeopardize the interpretation of the study results according to the investigator criteria
* For the PSG sub-study, participants currently treated with drugs that may interfere in PSG data interpretation (e.g. antidepressants or benzodiazepines).
Minnesota HealthSolutions Cellular Car Seat Study

The objective of the study is to evaluate an innovative child safety seat user engagement system (CCS system) designed to actively educate, instruct, and alarm caregivers with information associated with automatically-sensed safety seat misuses/errors via a smartphone application.

The primary objective of the study is to evaluate whether child safety seat users correct more critical misuse errors in child safety seat usage with the seat with the CCS system than the same seat with no sensor system. The CCS system will provide ongoing, tailored support to users at the time of an error. Videos will be available to users via a smartphone and provide short "how to" instructions that demonstrate how to correctly perform each safety seat behavior (e.g., tighten harness straps) and how to avoid common mistakes. The overall goal of the CCS system is to prevent child safety seat critical misuses and reduce deaths and injuries in children riding in motor vehicles. In the proposed study, adult participants will be asked to attend one in-person study visit and complete three (3) scenarios in which they will be asked to identify and correct errors in child safety seat use. Participants will be randomized to either the intervention group which will use the CCS system during each scenario or the control group which will not use the CCS system during each scenario.

Eligibility Criteria:
Inclusion Criteria:

* Males or Females ages 18-75 years
* Has harnessed/fastened a child into a car seat in the last five (5) years
* Has a valid driver's license

Exclusion Criteria:

* Non-fluency in written and/or spoken English
* Participant cannot install a safety seat due to a physical or health limitation
A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients

Randomised, double-blind, parallel group study to compare PK and PD profiles between IBI301 and rituximab in patients with CD20+ B-cell Lymphoma


Eligibility Criteria:
Inclusion Criteria:

1. CD20-positive B-cell lymphoma.
2. 18 years to 65 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
4. Signed an informed consent.
5. Obtained CR (complete remission) or CRu (uncertain complete remission) after the prior therapy.

Exclusion Criteria:

1. Participation in another interventional clinical trial in the past 28 days.
2. Known allergic reactions against monoclonal antibody or rituximab.
3. Rituximab and other anti-CD20 monoclonal antibody used in the past 4 months.
4. Blood concentration of Rituximab\>24ug/ml.
5. HIV positive patients.
6. HCV antigen and antibody positive.
7. Acute and chronic hepatitis B virus infection.
Clinical Study to Assess a Dietary Supplement on Sleep Health and Quality

The primary objective of this study is to evaluate the effects of a proprietary oral supplement on the sleep health and quality of people with sleep problems. It is a double-blinded placebo-controlled crossover clinical study.


Eligibility Criteria:
Inclusion Criteria:

* Non-smokers
* Judged by the Investigator to be in general good health on the basis of medical history
* Willing to wash out of all dietary supplements, essential oils, and non-prescription sleep aids or Rx sleep aids for the duration of the study
* Insomnia Severity Index score of ≥ 8
* Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study

Exclusion Criteria:

* Pregnant and/or lactating women
* Known allergy or adverse reaction to ingredients in the product: Tri Factor (bovine colostrum and egg yolk extracts), Ashwagandha root extract, Lavender, Pyridoxal-5-Phosphate, Melatonin, gamma aminobutyric acid (GABA) or Magnesium
* Prescription sedative or psychoactive (including anti-depressant) medication use
* Diagnosis of a sleep disorder (e.g., sleep apnea, periodic limb movement disorder, etc.) or high clinical probability of another sleep disorder based on sleep history
* A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 4 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer)
* Routine consumption of more than 2 alcoholic beverages per day or consumption of caffeine past 2 PM for the duration of the study
* Illicit drug use
* Use of prescription stimulants (modafinil, dextroamphetamine, etc.)
* Use of prescription medications known to affect sleep (antidepressants, anti-anxiety, opioids, alpha-blockers, beta-blockers, corticosteroids, ACE inhibitors, angiotensin II-receptor blockers, cholinesterase inhibitors, allergy medication, asthma medication, glucosamine and chondroitin, statins, anti-smoking or thyroid medication, muscle relaxants, anticonvulsants)
* Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 10th grade reading level; visual, hearing or upper extremity motor deficit
* Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months
* Unwilling to consume or unable to swallow capsules/tablets
* Previous exposure to this product in earlier testing phases
Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.


Eligibility Criteria:
Inclusion Criteria:

* HIV-1 infected on HAART regimen containing 2 NRTI and boosted PI for at least 12 weeks prior to screening. Subjects may not have experienced virological failure to more than one prior PI-containing regimen. Must be able to swallow tablets
* Viral load \<400 c/mL at screening and stable for at least 6 months
* Signs of fat redistribution and lipohypertrophy (abdominal) Waist to Hip Ratio \>0.90 and Waist Circumference \>88.2 cm for men and Waist Circumference \>75.3 for women

Exclusion Criteria:

* Pregnant or breastfeeding women
* New HIV-related opportunistic infections
* Active alcohol or substance use
* Grade 4 lab toxicity
* History of taking atazanavir (ATV)
* Prohibited therapies, including non-nucleoside reverse transcriptase inhibitors (NNRTI)
Trans-spinal Magnetic Stimulation (TsMS) in Parkinson's Disease- Related Musculoskeletal Pain

Parkinson disease is the second most common neurodegenerative disease. Pain is the frequent non-motor symptom that significantly compromises the quality of life, affecting 80% of patients during the course of the disease. There is currently no evidence-based treatment for PD-related pain in general. Nociceptive pain is the most frequent pain in PD an is frequently musculoskeletal in nature. Epidural spinal cord stimulation is known to provide analgesic effects in several types of pain syndromes. Here we test analgesic effects of a non-invasive trans-spinal magnetic stimulation as an add-on treatment for nociceptive (musculoskeletal) pain directly related to Parkinson disease.

Background: pain is frequent non-motor symptom in Parkinson's disease (PD) that significantly compromises the quality of life, affecting 80% of patients during the course of the disease. Nociceptive pain is the most frequent subtype, mainly musculoskeletal in nature. There is currently no evidence-based treatment for PD-related pain in general. The present study tests the effectiveness and safety of non-invasive trans-spinal magnetic stimulation (TsMS) to treat musculoskeletal pain directly related to PD in a sham-controlled randomized approach.

Patients and Methods: this is a randomized, sham-controlled trial including 40 subjects, aged between 18 and 85 years, with musculoskeletal pain directly related to PD, that will be randomized to receive TsMS active or TsMS sham in a 1:1 ratio. Enrollment will take place at the Pain Center of the University of São Paulo and Movement Disorders Center of the University of São Paulo.

We have decided to perform an interim analysis when 24 patients will be included in the trial in order to assess safety and calculate effect size of the active intervention, after meeting with the research and statistical board. A decision will thereafter be made to, either: 1: halt the study due to futility, 2: continue the study with a new target sample size based on the calculations made with the effect from the n= 24 sample.

Expected results: the study hypothesis is that non-invasive trans-spinal magnetic stimulation is superior to sham and it is safe to use that device in patients with nociceptive (musculoskeletal) pain in PD.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson disease
* Parkinsson disease related musculoskeletal Pain
* Signed term of informed consent

Exclusion Criteria:

* Pregnant or lacting women
* Predominant neuropathic pain
* The presence of psychiatric disorders such as uncontrolled posttraumatic stress disorder, uncontrolled depression, uncontrolled anxiety disorder and suicidal ideation;
* Who wishes at any time to abandon the study;
A Study of YM060 in Diarrhea-predominant Irritable Bowel Syndrome (d-IBS)

This study will examine the efficacy, safety and tolerability of different oral dose of YM060, 5-HT3 receptor antagonist, in patients with d-IBS.


Eligibility Criteria:
Inclusion Criteria:

* Patient meets Rome II criteria for IBS and the subgroup of diarrhea predominant IBS

Exclusion Criteria:

* Patient with severe cardiovascular disease, respiratory diseases, renal diseases, hepatic diseases, digestive tract diseases (excluding IBS), blood diseases, or neurological or psychiatric diseases
* Patient reported having any Type 1 or Type 2 stool on the Bristol Stool Form Scale during the run-in period
Molecular Characterization of Moraxella Catarrhalis From Pneumonic Children at Pediatric Assiut University Hospital

moraxella catarrhalis is responsible for respiratory tract infection in children and adults with streptococcus pneumonia and haemophilus influenza.Moraxella catarrhalis is gram negative diplococci, non-motile and non spore bearing bacteria. Until, 1995 it was considered as a non pathogenic respiratory tract flora.This bacteria is an important pathogen and a common cause of both upper and lower respiratory tract infections, pneumonia, sinusitis and conjunctivitis in infants, children and in elderly patients. In adults, M. catarrhalis also causes chronic obstructive pulmonary disease (COPD) and pneumonia. However, it is associated with a number of respiratory infections affecting both children and adults, including laryngitis, bronchitis and pneumonia .

This institution is polymicrobial community with other pathogens such as Streptococcus pneumoniae and Haemophilus influenza (Sethi and Murphy, 2008). The pathogenicity of M. catarrhalis is mediated by several virulence genes, including the ubiquitous surface protein genes A1 (uspA1) and A2 (uspA2), which encode virulence factors that promote colonization and successful host infections (Bernhard S et al.,2012).Bacterium was first isolated in 1896, it was considered to be a harmless commensal of the upper respiratory tract for a long period of time. The bacterium rapidly colonizes the nasopharynx soon after birth asymptomatically (Blakeway et al., 2017).

Eligibility Criteria:
Inclusion Criteria:

* all children with bacterial pneumonia

Exclusion Criteria:

* viral pneumonia , tuberculosis and immunocompromised
Evaluation of a Motion-Activated Refusal-Skills Training Video Game for Prevention of Substance Use Disorder Relapse

The project proposes to continue the development of an intervention for relapse prevention in the form of a professional quality video game which rewards drug-rejecting physical motions and spoken refusal phrases. Phase I research findings showed that youth in recovery experienced increased low craving levels, strong levels of satisfaction, and interest in attending treatment sessions where the intervention is available - an important outcome since failure to attend treatment is highly correlated with relapse. In Phase II, the investigators propose to modify and expand the prototype based on customer feedback from treatment centers, counselors and patients. The investigators will test the effectiveness of the motion and voice-controlled game in a randomized controlled trial of youths in treatment for opioid use disorder who have access to the game for a month. The investigators will measure the effect of gameplay on successful completion of detoxification/inpatient treatment and rates of linkage to next level of outpatient treatment. The investigators will also measure the effect of gameplay compared to treatment as usual (TAU) during a subsequent episode of outpatient treatment (following inpatient), on rates of treatment attendance, treatment retention, urine drug test results, substance use self-report, treatment alliance, drug craving, and treatment satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* attending the MMTC inpatient program for primarily opioid or marijuana use disorder treatment
* ability to speak English

Exclusion Criteria:

* presence of a comorbid psychiatric condition that would make participation unsafe (eg, acute suicidality or unstable psychosis)
* pregnancy (because of the physical exertion required to play the game)