cyrilzakka/clinical-trials huggingface dataset:
A Mobile Health Intervention to Reduce Sweet Beverage Consumption in Latino Children

Sugar-sweetened beverage consumption is a major contributor to childhood obesity, caries, fatty liver disease, and Type 2 diabetes. Latino children are more likely to consume sugar-sweetened beverages (SSBs) and to suffer from all of the aforementioned conditions. Reading out loud to children from birth through age 5 is critical for the promotion of language and early literacy skills. Children whose parents read aloud to them are more likely to start school with the skills required for early reading success. This is important as reading proficiency in third grade is the best predictor of high school graduation and career success. Latino children are less likely to be read to than non-Hispanic white children and at higher risk of entering kindergarten without critical early literacy skills. Thus, there is a pressing need for interventions to reduce SSB consumption among Latino children as well as interventions that promote reading out loud. Primary care is an optimal setting for such interventions. However, multiple demands on providers' time make it difficult to rely on in-person interventions. For this reason, it is critical to test intervention designs that do not rely directly on health care providers and that can be delivered remotely if needed. The investigators have developed two m-health interventions for Latino parents, one that promotes optimal beverage consumption patterns and one that promotes reading out loud to children. The purpose of this study is to test the impact of these interventions on child beverage intake patterns and the frequency with which parents read to children.


Eligibility Criteria:
Inclusion Criteria:

* Parent identifies child as Latino/a/x
* Child age 1 to 5 (12 to 59 months)
* Parent has a cell phone that can receive text messages
* Parent speak English or Spanish

Exclusion Criteria:

• Child does not feed by mouth
Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and over inclusive.
* Males or females
* Patient is in generally good \& stable overall health.
* Patient likely to comply with study guidelines \& study visits.
* Informed consent signed.
* OSDI score \>18 OR
* TBUT \<10 seconds

Exclusion Criteria:

* Corneal refractive surgery or contact lens wear within 6 months of this study.
* Current use of Restasis
* Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
* Pregnant or lactating women.
* Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
Window Study of ZD4054 in Metastatic Prostate Cancer

This is a prospective study in which patients with castrate-resistant prostate cancer and bone metastases will undergo imaging, donate blood, bone marrow and urine samples, and where possible primary tumour and bone metastatic tissue, before and during treatment with ZD4054, an orally active specific endothelin-A antagonist. The samples will be used primarily for biomarker studies, and it is hypothesized that these will inform on the mechanism of action of this drug. Magnetic Resonance Imaging (MRI) will be performed to evaluate emerging functional imaging endpoints as markers of early response in bone metastatic prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* histological confirmation of prostate adenocarcinoma
* documented evidence of bone metastasis on bone scan or MRI
* biochemical progression of prostate cancer
* surgically or medically castrate with serum testosterone ≤2.4nmol/L
* ECOG performance status 0 - 2
* life expectancy of 6 months or more.

Exclusion Criteria:

* radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment.
* prior targeted cancer therapies (such as gefitinib, bevacizumab)
* systemic radionuclide therapy within 12 weeks of starting study treatment.
* current therapy, within 4 weeks of study entry with potent inhibitors of CYP3A4 (ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of CYPs 2D6 and 2C9 (quinidine and fluconazole), and potent P450 inducers (phenytoin, rifampicin, carbamazepine and phenobarbitone)
* definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists
* ineligibility for MRI scanning includes standard MRI criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based MRI contrast agents
Evaluation of Comfilcon A and Senofilcon A Lenses

Evaluation of Comfilcon A and Senofilcon A Lenses

Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.

Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

* Has had an oculo-visual examination in the last two years
* Is at least 18 years of age and has full legal capacity to volunteer
* Has read and understood the information consent letter
* Is willing and able to follow instructions and maintain the appointment schedule
* Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
* Currently wears soft contact lenses at least 3 days a week, 8 hours a day
* Has clear corneas and no active ocular disease
* Has not worn lenses for at least 12 hours before the examination
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

  * No amblyopia
  * No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes)
  * No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
  * No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
  * No aphakia
  * Has prescription to match the available power range.

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

* Greater than 0.75 of refractive astigmatism in either eye
* Has never worn contact lenses before
* Wears contact lenses on an extended wear basis
* Has any systemic disease affecting ocular health
* Is a known sufferer of ocular allergies
* Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
* Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
* Is aphakic
* Has undergone corneal refractive surgery.
* Is wearing monovision
* Is participating in any other type of clinical or research study
* Female who is currently pregnant or is breast-feeding
* Has \> grade 1 ocular corneal staining in both type and extent by \> grade 2 in either type or extent
Debio 1143-201 Dose-finding and Efficacy Phase I/II Trial

The use of multiple drugs in a single clinical trial or as a therapeutic strategy has become common, particularly in the treatment of cancer. Because traditional trials are designed to evaluate one agent at a time, the evaluation of therapies in combination requires specialized trial designs. In place of the traditional separate phase I and II trials, this trial uses a single phase I/II clinical trial to evaluate simultaneously the safety and efficacy of combination dose levels, and select the optimal combination dose.

Therefore, this is a two part trial of Debio 1143 combined with concurrent cisplatin and radiotherapy (CRT) in participants with previously untreated stage III, IVa or IVb head and neck cancer. The trial begins with an initial period of dose escalation (Phase I) to investigate the maximum tolerated dose (MTD) of Debio 1143 that can safely be given in combination with CRT.

Using the MTD determined in the Phase I portion, the randomized phase II trial in 94 participants compares Debio 1143 to placebo, both with concomitant CRT. The aim is to evaluate the efficacy and safety of Debio 1143.


Eligibility Criteria:
Inclusion Criteria:

* Meets protocol-specified criteria for qualification and contraception
* Is willing and able to comply with study procedures and restrictions related to food, drink and medications
* Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion Criteria:

* Has history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters
* Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff;
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding);
  3. the analysis of results
Evaluation of Hypertension Management and Cardiovascular Adverse Event Prevention in Patients with B-cell Malignancies Undergoing Treatment with Bruton Tyrosine Kinase Inhibitors, the HALT Study

This study evaluates the incidence and management of new and worsening high blood pressure in patients with B-cell cancers on BTKi treatment.

PRIMARY OBJECTIVES:

I. To prospectively define the incidence of new and/or worsening HTN in patients with B-cell malignancies on BTKi.

II. To identify the hemodynamic changes associated with new and/or worsening HTN in patients with B-cell malignancies on BTKi by impedance cardiography (ICG) and thereby to define the optimal anti-hypertensive strategies.

III. To compare 1-year MACE rates between patients with B cell malignancies on BTKi with new or worsening HTN on optimal anti-HTN strategies with patients who do not develop HTN on BTKis.

OUTLINE: This is an observational study.

Patients attend hypertension clinic visits, undergo optional blood pressure monitoring, electrocardiograms, impedance cardiography testing and blood and urine sample collection and have medical records reviewed throughout study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom macroglobulinemia (WM), and marginal zone lymphoma (MZL), planned to begin Bruton tyrosine kinase inhibitors (BTKi) treatment or who will start a new BTKi agent after a 5-day wash out period (either as a single agent or on combination with other chemotherapies), who are willing to return to Mayo Clinic for ongoing follow-up

Exclusion Criteria:

* Patients with known central nervous system (CNS) involvement of their B-cell malignancy
MERITnI - Mindray-hs-cTnI Assay: Analytical and Clinical Evaluation for the Diagnosis and RIsk AssessmenT of Myocardial InfarctIon.

The Mindray High Sensitivity Troponin-I Measurement System is an in vitro diagnostic test for the quantitative determination of high sensitivity cardiac troponin I (hs-cTnI) in human serum or plasma.

The Mindray High Sensitivity Troponin-I Measurement System is to be used as an aid in the diagnosis and rule out of acute myocardial infarction (AMI).

Study purpose/objective:

* Determine the sex-specific 99th percentile upper reference limits (URLs) for the Mindray hs-cTnI assay using the CL-1200i Instrument.
* Method comparison across the dynamic range of cTnI concentrations between the Mindray hs-cTnI assay and the Abbott Alinity hs-TnI assay used in clinical practice at Hennepin Healthcare/Hennepin County Medical Center.
* Evaluate the clinical performance of the Mindray hs- cTnI measuring system for the diagnosis of myocardial infarction (MI), for early rule out MI and myocardial injury, and assessment of 30-day safety outcomes in patients presenting to the emergency department (ED) in whom serial cTnI measurements (0h, 2h, 4h, 6h) are obtained on clinical indication at Hennepin Healthcare / Hennepin County Medical Center (Minneapolis, MN USA) to rule-in and rule-out MI.

Eligibility Criteria:
Inclusion Criteria:

1. Presents to the ED, or ambulatory care center equivalent, with signs or symptoms suspicious of a possible ACS/ischemic event.
2. Baseline cTn-I measurement and one additional cTn-I measurement at two hours after the first measurement.
3. At least one 12-lead electrocardiogram

Exclusion Criteria:

1. Less than 21 years old
2. Pregnancy
3. Trauma
4. Declines to participate or has indicated that their blood/ medical information cannot be used for investigational purposes
5. Did not present through the ED
6. Transferred from an outside hospital or clinic
7. Has already been enrolled in the study
Phenotype, Genotype & Biomarkers in ALS and Related Disorders

The goals of this study are: (1) to better understand the relationship between the phenotype and genotype of amyotrophic lateral sclerosis (ALS) and related diseases, including primary lateral sclerosis (PLS), hereditary spastic paraplegia (HSP), progressive muscular atrophy (PMA), and frontotemporal dementia (FTD); and (2) to develop biomarkers that might be useful in aiding therapy development for this group of disorders.

This study will recruit patients with ALS, ALS-FTD, PLS, HSP, and PMA, with a focus on incident cases. Patients with both familial and sporadic forms of these diseases will be enrolled and followed longitudinally using a standardized set of evaluations. Biological samples (blood, urine, CSF) will be collected from all study participants, and will be used for biomarker discovery and validation. Family members of affected individuals may also be enrolled and asked to contribute DNA and biological samples to aid genetic and biomarker discovery.

Eligibility Criteria:
Inclusion Criteria:

* Member of at least one of the following categories:

  1. Individuals with a clinical diagnosis of ALS or a related disorder, including FTD, HSP, PLS, PMA and MSP (sporadic or familial).
  2. Family member of an enrolled affected individual.
* Able and willing to comply with relevant procedures.

Exclusion Criteria:

* Affected with end or late stage disease.
* A condition or situation which, in the PI's opinion, could confound the study finding or may interfere significantly with the individual's participation and compliance with the study protocol. This includes (but is not limited to) neurological, psychological and/or medical conditions.
Effect of Hip Adductors Isometric Contraction on Knee Extensors Isokinetic Torque in Patellofemoral Pain Syndrome

the study will be done to investigate the effect of hip adduction isometric contraction on the pain level by VAS and knee extensors peak torque by using the isokinetic dynamometer in patients with unilateral patellofemoral pain syndrome

the study will be done to investigate the effect of isometric hip adduction that will be measured by the hand held dynamometer (the manual muscle tester) to measure the produced adduction torque and its effect on the peak torque of knee extension by the knee extensors which will be measured by the isokinetic dynamometer in addition to measuring the pain intensity before and through the assessment by using the visual analogue scale

Eligibility Criteria:
Inclusion Criteria:

* Anterior or retro-patellar knee pain from at least 2 of the following Activities: (1) prolonged sitting; (2) stair climbing; (3) squatting; (4) running; (5) kneeling; and (6) hopping/jumping (Tyler et al., 2006).
* Insidious onset of symptoms unrelated to a traumatic incident and persistent for at least 6 weeks (subacute or chronic pain).
* They will be diagnosed as a PFPS case by a physician
* The patient's age will be ranged from 18-35 years to limit the possibility that PFPS over age 35 may have been complicated by arthritic changes, and also the patients should have closed epiphyseal growth plates (Robinson and Nee, 2007).

Exclusion Criteria:

* A history of any of the following condition: meniscal or other intra articular pathologic conditions; cruciate or collateral ligament involvement.
* A history of traumatic patellar subluxation or dislocation.
* Previous surgery in the knee and hip joints.
* Any lower limb bony/congenital deformity.
* Ankle, Knee and hip joints osteoarthritis.
* A history of any conditions affects muscle strength: diabetes mellitus, rheumatoid arthritis.
* Pregnancy.
Effects of Oral Stimulation in Preterm Infants

Preterm infants with gestational age inferior to 34 weeks were included in the study. A prospective experimental group received the oral stimulation protocol and the effects of the intervention were compared with a historical control group that did not receive any oral stimulation intervention.

The study hypothesis is that oral stimulation in preterm infants has beneficial effects on the feeding performance, the length of hospitalization and anthropometric variables, including weight at discharge, height at discharge and head circumference at discharge.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with gestational age inferior to 34 weeks

Exclusion Criteria:

* Instability caused by respiratory, cardiac or gastrointestinal issues
* Orofacial malformations.
Clinical Trial of Electro-Acupuncture Preconditioning in Patients Underwent Heart Valve Replacement Surgery

The purpose of this study is to investigate the protective effect of electro-acupuncture preconditioning in patients underwent cardiac surgery.

Heart valve replacement surgery has been proved to be an effective method in treating both regenerative and rheumatic valve disease. Current studies showed that cardiopulmonary bypass (CPB) and operation related myocardial injury, as indicated by the release of perioperative cardiac enzymes, is associated with worse patient morbidity and mortality after elective valve replacement surgery. Although the actual mechanism is still unclear, it has been shown that ischemic preconditioning is one potential strategy for reduction of myocardial injury in open heart surgery. Recently, Electro- acupuncture (EA) was proved to produced cerebral protective and antiarrhythmic effects by mimicking ischemic preconditioning. This study aims to assess whether electroacupuncture preconditioning is also effective in reducing myocardial injury in adults with acquired heart valve disease undergoing elective valve replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients who have the indication for aortic or mitral valve replacement
* patients would like to accept the follow-up and sign the informed consent
* patients with heart function of NYHA I-III degree.

Exclusion Criteria:

* pregnant or nursing women
* comorbid with coronary artery disease
* patients with heart function of NYHA IV degree
* renal dysfunction with serum creatinine level\>or=2mg/dl(177umol/L)
* anticipated life span \< 12 months
* enrollment in other clinical trials at the same time not reaching the primary endpoint and probably interference the present trial.
Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti^® in Knee Cartilage Defects

Subjects aged 50 to 65 years with knee cartilage defects will undergo microfracture treatment for cartilage regeneration and MegaCarti\^® will be applied.

The MegaCarti\^® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow.

To evaluate cartilage regeneration, the study group is compared with the microfracture group alone through MOCART evaluation at 48 weeks after treatment for cartilage regeneration. In addition, a biopsy is performed to evaluate the formation of hyaline cartilage and the area ratio of regenerated cartilage is measured.

Eligibility Criteria:
Inclusion Criteria:

1. 50 years to 65 yaers
2. After receiving a detailed explanation of this clinical trial and fully understanding it, the subject or legal representative voluntarily decides to participate in the clinical trial and sign the consent form
3. Subjects with localized full-thickness cartilage defects in the knee joint, International Cartilage Repair Society(ICRS) Grade III or IV
4. Subjects whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms
5. knee cartilage defect size :1.5cm\^2 to 10cm\^2

Exclusion Criteria:

1. Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
2. When screening, Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (However, arthroscopy for diagnostic purposes is possible. Additionally, it is possible if hightibial osteotomy (HTO) has been performed in advance or is scheduled)
3. When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 1 month
4. When screening, Patients who took oral steroid within 2 weeks
5. Patients who can't take MRI scan
6. BMI index : 30kg/m\^2 or over
7. Patients who have gout or gout history in the knee
8. Women who are pregnant or breast-feeding, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
9. Patients with risk factor for bleeding
10. Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
Stretching and Pain Sensitivity

Stretching is frequently used in clinical practice to manage musculoskeletal discomfort and to prevent sports injuries. It is not known if stretching affects pain sensitivity. The purpose of this study is to investigate if a 4 week daily stretching protocol alters pain sensitivity.

The investigators hypothesize that stretching reduces pain sensitivity.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 40
* In general good health, in the opinion of the Investigator, based on medical and physical history.
* Speaks, reads and writes Danish language.

Exclusion Criteria:

* Regular use of stretching
* History of surgery to the lower limb(s)
* History of traumatic and overuse injures to the lower limb(s), including but not limited to: Tendinopathies, Bursitis, Muscle injuries, Significant ankle sprains, other ligament injuries
* Hyper mobility syndromes, including but not limited to Ehlers-Danlos syndrome, Generalised hyper mobility syndrome
* History of symptoms of autoimmune disorders (e.g., inflammatory bowel disease, multiple sclerosis, lupus, rheumatoid arthritis).
* Planned surgical procedure during the duration of the study
* History, diagnosis, or signs and symptoms of clinically significant neurological disease, including but not limited to: Stroke or transient ischemic attack, Alzheimer's disease or other types of dementia, Clinically significant head trauma within the past year, Peripheral neuropathy, Epilepsy or seizure, Impaired balance
* Alcohol or drug abuse within the last 5 years
* History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder
* Diabetes
* Subjects with regional pain syndromes suggestive of lumbar compressions with radiculopathy or at risk of developing radiculopathy.
* Any other condition, which in the opinion of the Investigator, would put the subject at increased safety risk or otherwise make the subject unsuitable for this study.