cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Blue Star MAX-5 Lenses in Myopia Control

The goal of this randomised controlled clinical trial is to compare the effects of a new type of concentric columnar microstructure lens and single-vision spectacle lenses on myopia progression in Chinese children aged 8-11 years with refractive error ranging from -0.50D to -6.00D. Participants will wear spectacles and receive follow-up examinations every half year.


Eligibility Criteria:
Inclusion Criteria:

* Aged 8 to 11 years;
* Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -6.00 to -0.50 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D;
* Best-corrected visual acuity of equal or better than 0.00 LogMAR (\>= 1.0 as Snellen).
* The intraocular pressure of 10 to 21mmHg.
* Volunteer to participate in this clinical trial with signature of the informed consent form.

Exclusion Criteria:

* History of eye injury or intraocular surgery;
* Clinically abnormal slit-lamp findings
* Abnormal fundus examination
* Ocular disease, such as uveitis and other inflammatory diseases, glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function;
* Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses);
* Participation of the drug clinical trial within three month and the device clinical trial within one month;
* Only one eye meets the inclusion criteria;
* Unable to have regular follow-up
* Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursingproducts), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.
Neotililty Trial: Effect of Coenzyme Q10 on Semen Parameters in Men With Idiopathic Infertility

To study the effect of coenzyme Q10 on semen parameters in men with idiopathic infertility

Decreased serum CoQ10 concentrations as well as a decrease in the CoQ10H2 to-ubiquinone ratio have been demonstrated in diseases associated with OS. A strong correlation among sperm count, motility and ubiquinol-10 levels in seminal fluid has also been reported.

The aim of the present study is to investigate whether the effects of the exogenous administration of ubiquinol in the improvement of semen parameters in Pakistani men population.

Patients who full filled the inclusion criteria and gave informed written consent will be included in the trial. Patient will start to take medication and will take it for 26 weeks.

All men undergo a thorough physical examination, a detail history, serum biochemical and hematological laboratory tests and measurement of serum sex and thyroid hormone levels. A questionnaire will be used to collect information on demographic characteristics. Two semen samples 1 and 2 month apart will be obtained after 3 to 5 days of sexual abstinence and process within 1 hour of ejaculation. The mean of the two will be used for statistical analysis. Semen analyses will be performed using WHO recommended methods.

3 ml of blood will be withdrawn from the patient for the serum hormones analysis and total amount of semen will required for analysis of semen parameters.

Sponsor will bear the test cost of patient during the study treatment period.

Eligibility Criteria:
Inclusion Criteria:

* To sign the Informed Consent form
* Patients will be recruited in the study if they will fulfilled the criteria of history of primary infertility of more than 2 years, abnormal sperm count and motility
* age between 20 and 50 years
* No known medical or surgical condition which can result in infertility

Exclusion Criteria:

* Voluntary withdrawal
* Poor compliance of visit/treatment
* A history of cancer chemotherapy or radiotherapy
* A history of genital disease such as cryptorchidism and varicocele; a history of genital surgery
* Body mass index 30 kg/m or greater; any endocrinopathy
* Ychromosome microdeletions or karyotype abnormalities
* leukocytospermia
* Drug or substance abuse; tobacco use;
* Use of anticonvulsants, androgens or antiandrogens
* Significant liver (serum bilirubin greater than 2.0 mg/dl)
* Renal function (serum creatinine greater than 2.0 mg/dl) impairment
* Patients with severe oligozoospermia (less than 5 X 106/ml), azoospermia and testicular volume less than 12 ml will also excluded from study.
Impact of Endothelial and Leukocyte Senescence in Circulatory Shock States

Circulatory shocks (CS) are life-threatening, acute organ dysfunction. Advances in critical care medicine have decreased early hospital mortality, increasing the number of surviving patients. Regrettably, these survivors are at increased risk of new infections but also of cardiovascular disease.

The investigators hypothesize that CS with multi-organ dysfunction is associated with premature senescence of endothelial cells and immune cells and promotes endothelial thrombogenicity and immunosenescence leading to cardiovascular disease and secondary infections.

The aim of this work is therefore to evaluate the contribution of endothelial and leucocytes senescence to the occurrence of secondary events (infectious and cardiovascular) in patients with a CS. It will provide a better understanding of the pathogenesis of cardiovascular and immune diseases following a CS, likely to guide new management strategies to prevent their occurrence.


Eligibility Criteria:
Inclusion criteria:

* Circulatory shock
* patient with health care insurance

Exclusion criteria:

* Patients' refusal to participate in clinical research
* Pregnant woman
* Breastfeeding woman
* A patient with a protective order
Goal Setting and Lifestyle

The primary aim of this feasibility study is to determine if a theory-based lifestyle intervention consisting of telephone counseling is associated with improvements in physical activity and dietary intake.

Goal setting has become an integral part of physical activity and dietary interventions; however, few studies have examined the theoretical constructs that drive goal-setting theory. To address the limitations and gaps in the literature, we designed an 8-week health behavior intervention for a racially and ethnically diverse sample of older adults. The primary aim of this study was to determine whether older adults randomized to a goal-setting intervention for physical activity or fruit and vegetable (F\&V) intake would make significant improvements in physical activity or F\&V intake. The secondary aim of this study was to determine whether participating in goal-setting interventions was associated with changes in theoretical constructs related to goal-setting. We hypothesized that older adults assigned to the physical activity condition would significantly increase metabolic minutes (MET-minutes) of physical activity from baseline to follow-up and that participants assigned to the F\&V intake condition would significantly increase mean servings of F\&V. In addition, we hypothesized that mean scores of goal specificity, difficulty, effort, commitment, persistence, barrier self-efficacy, and task self-efficacy would significantly increase from baseline to follow-up for both groups.

Eligibility Criteria:
Inclusion Criteria:

* must be 55 years or older,
* posses a telephone,
* able to give informed consent, and
* commit to a 10 week study.

Exclusion Criteria:

* currently enrolled in a study promoting physical activity or dietary intake,
* currently exceeding current recommendations for physical activity or F\&V intake at baseline, and
* medical conditions contraindicating physical activity or fruit and vegetable consumption.
Validation Sonic Bone's Ultrasound System for Bone Age Assessment

The selection of talents in junior sports is strongly influenced by the current physical conditions of the athletes. However, the physical abilities, for example in junior football, are largely dependent on the maturation and show a high degree of variability during puberty. For example, the maturity status in an U14 football team fluctuates by up to 5 years between early and late developed players. It is necessary to include the maturation in junior sports in selections in order to give all athletes the same chance of selection regardless of their maturity status. This will make selections fairer and the promotion of athletes with the highest potential will be better implemented. Bone age is considered to be an objective indicator of the maturation. For this purpose, a practicable and preferably radiation-free method for determining bone age is needed. A new medical device promises to determine bone age based on ultrasound technology. This now offers the chance to switch to a significantly less stressful technique. The aim of the study is to determine the quality criteria (validity and reliability) of this new method in order to decide whether the current gold standard of the X-ray method could be replaced by a less stressful method.


Eligibility Criteria:
Inclusion Criteria:

* Age between 10-18
* healthy
* voluntary participation
* consent of the participant or legal representative to participate in the project
* active in a sports club

Exclusion Criteria:

* pregnancy
Innovative Approaches to Increase F&V Intake Thru Worksites

The purpose of this project is to study the efficacy of a delivery system to offer fresh fruits and vegetables (F\&V) at discount prices for purchase at worksites in conjunction with educational interventions on increasing employees' F\&V consumption in comparison to an intervention receiving fruit and vegetable markets alone or a comparison intervention.

"Good to Go" (GTG) is a cluster randomized trial, which is studying the efficacy of innovative multi-level worksite interventions including educational/behavioral interventions and/or a fruit and vegetable (F\&V) market at the worksite to improve F\&V intake of employees. The hypothesis is that providing convenient, inexpensive access to F\&V at the workplace through a F\&V market will increase the availability of F\&V at the workplace as well as at home and increase F\&V intake of the employee. However, because it is unclear if improving F\&V access and availability alone is adequate to increase F\&V intake, the investigators will test the efficacy of the F\&V delivery intervention alone and in combination with a promotional/educational intervention delivered at the worksite. The efficacy of these innovative interventions will be tested during a cluster randomized trial with 21 worksites to determine which interventions are most efficacious in increasing F\&V consumption.

The primary specific aims of this proposed research are to employ a cluster randomized trial to study the efficacy of delivering fresh F\&V at reduced prices for purchase at worksites (access intervention); the F\&V delivery intervention paired with educational interventions to change informational and social environments at the worksite (enhanced intervention); and a comparison intervention acting as an attention placebo. The study will compare the efficacy of the Access intervention and the enhanced intervention with the comparison Arm and will also compare the efficacy of the Access intervention to the Enhanced intervention.

Eligibility Criteria:
Inclusion Criteria:

* works at least 25 hours per week at the worksite
* is on-site at least half of every day shift during the week
* reads and understands English.

Exclusion Criteria:

* has a medical condition that would prevent consumption of most fruits and vegetables,
Enhancing Behavioral Treatment for Women With Pelvic Floor Disorders

The purpose of this proposal is to test a novel behavioral treatment - Unified Protocol Cognitive-Behavior Therapy (UP-CBT)1 - to enhance quality of life in women with pelvic floor disorders. Emotional distress is treatable using behavioral procedures, and effective treatment would increase women's emotional health and help to reduce urinary symptoms (e.g., incontinence, frequent urination). Women with pelvic floor disorders are often seen in the urogynecology clinic, which makes this setting ideal for offering additional interventions that may improve their quality of life. Unfortunately, many women with pelvic floor disorders may not receive effective behavioral treatment, such as cognitive behavior therapy, because urogynecologists and other medical professionals may not be aware of providers in their community who offer this treatment. The investigators will enhance treatment options by 1) providing evidence for an all-purpose cognitive-behavioral intervention (i.e., UP-CBT), 2) offering treatment in the urogynecology clinic, maximizing convenience, and 3) improving clinical outcomes for these patients.

Specific Aims:

1. To demonstrate that UP-CBT is an effective form of therapy for women with lower urinary tract symptoms.
2. To use baseline characteristics in moderation analyses to determine which women will be most likely to have a good response to therapy.
3. To use mediation analyses to test a possible causal chain of events - Does treatment lead to lower anxiety, which in turn leads to fewer urinary symptoms?


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18 years or older
* Presence of one or more of the following urinary symptoms in past 12 months and currently seeking treatment: frequency, nocturia, urgency, leakage, hesitancy, straining, or dribbling
* Willing and able to provide informed consent
* Anxious presentation and/or history of anxiety
* English speaking
* Willing to defer usual treatment for urinary problems

Exclusion Criteria:

* Blood in the urine, positive urine culture, signs of infection
* Pregnant, or 6 months or less postpartum
* Psychosis, dementia, or other cognitive impairment that would preclude participation
* Recent (within 6 months) pelvic or endoscopic surgery, urethral stricture, pelvic malignancy, current chemotherapy or other cancer therapy, pelvic device or implant complication
* Recent (within 12 months) Botox injection to the bladder or pelvic structures
* Currently in psychotherapy
* Current alcohol or substance use disorder
* Difficulty communicating in English
Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome

This study is conducted in Japan. The aim of this study is to collect information about the efficacy and safety of Norditropin® (somatropin) in the long-term treatment of short stature with GHD (Growth Hormone Deficiency) where epiphysial discs are not closed and short stature with Turner Syndrome where epiphysial discs are not closed.


Eligibility Criteria:
Inclusion Criteria:

* Growth hormone deficiency or short stature due to Turner Syndrome where the epiphyseal discs are not closed

Exclusion Criteria:

* Diabetic
* Patients with malignant tumors
* Women who are either pregnant or likely to be pregnant
* Known or suspected allergy to study product(s) or related products
Personalized Objects Can Improve the Diagnosis of EMCS From MCS

In this study，researchers will use personalized objects to assess patients' level of consciousness in chronic patients in minimally conscious state (MCS).

The Coma Recovery Scale-Revised (CRS-R) is an important tool for the assessment of behaviors in DOC.Clinical practice has shown that self-referential stimuli, such as the patient's own name and face, are more effective to elicit the patient's response than that of non-self-referential stimuli.

The item "Functional Object Use" was assessed by using personalized objects (e.g., cigarette, paper) and non-personalized objects, which presented in a random order.The rest assessments were performed following the standard protocol of CRS-R. The differences between functional use of the two types of objects was analyzed by Chi-square test.

Researchers expected to see some of the patients in MCS are re-diagnosed as EMCS with the using of personalized objects.

Eligibility Criteria:
Inclusion Criteria:

* patients in minimally conscious state;
* patients with stable condition;
* each patient has athletic ability to some extent.

Exclusion Criteria:

* premorbid neurology antecedent;
* patients in coma or vegetative state;
* patients \< 1 months after the acute brain injury.
CareLink Connect - Technical Evaluation Study

The purpose of this study is to evaluate the performance, patient satisfaction and safety of connectivity gateway device CareLink Connect, transferring CGM (Continuous Glucose Monitoring) data from a VEO insulin pump to CareLink online (every 5th minute) and thereby making it available for patients or Care Partners individual web connected devices such as smartphones, tablets and PCs.


Eligibility Criteria:
Inclusion Criteria:

1. Subject between the age of 12 - 65 years that has a clinical diagnosis of insulin requiring diabetes for at least 1 year
2. Subject is currently using a Paradigm® Veo™ Medtronic insulin pump for at least 3 months and willing to continue to use for the duration of the study.
3. Subject has sufficient Continuous Glucose Monitoring use experience, as determined by the Investigator, and is willing to continuously use CGM for the duration of the study.

   Guidelines to evaluate the patients experience are:

   i. Subject has a minimum of 30 days of CGM use within a year prior to enrollment.

   ii. Subject has experience with and is able to, or has a Care Partner who can:
   1. Insert/change sensor,
   2. Recharge the transmitter.
   3. Read sensor data in real-time on the insulin pump screen.
4. Subject is willing to, or has a Care Partner who can, perform at least the minimum required (2 per day) Blood Glucose readings to maintain CGM Sensor calibration.
5. Subject, if under the age of 18, has a Care Partner who is willing to participate to the study, attend the study visit with the subject, and complete user's feedback questionnaires and Care Partner diary. Care Partners are optional for patients of 18 years of age or older.
6. Subject and/or Care Partner have access to a computer with Internet access.
7. Subject and/or Care Partner have access to an Internet connected device.
8. Subject, or their legal guardian, is willing to allow a Care Partner to receive and view information transmitted by their Paradigm® Veo™ Medtronic insulin pump to a Mobile phone/Smartphone/tablet/PC via the CareLink Connect/CareLink Personal System.
9. Subject is willing to keep CareLink Connect device in the same room as themselves or regularly carry the study device with them and maintain its operational status (at approximately 16h per 24h).
10. Subject is willing to keep a short diary during the device use reporting time periods away(for more than one hour) from the CareLink Connect device.
11. Subject is in good general health as judged by the PI.

Exclusion Criteria:

1. Female subject is pregnant, per urine pregnancy test performed at screening in women of child-bearing potential
2. Female subject plans to become pregnant during the course of the study
3. Subject is unable to tolerate tape adhesives of the infusion set and CGM sensor
4. Subject has any unresolved adverse skin condition in the area of the pump infusion set or the CGM sensor placement (e.g. psoriasis, rash, Staphylococcus infection)
5. The subject has known cellular connectivity problem at their home
6. The subject is by the PI judged ineligible or unable to perform the study procedures jeopardizing the study results.
A Prospective Non-interventional Study to Evaluate Clinical Outcomes of Ribociclib Combined With Endocrine Therapy in Elderly Patients With HR+HER2 - Advanced Breast Cancer in Routine Clinical Practice in Russian Federation

This is а prospective, non-interventional, primary data collection study to evaluate the effectiveness, safety and quality of life in older patients (≥65 years) with HR+HER2- advanced breast cancer receiving ribociclib with ET in the first or second line in the real-life settings in Russia.

In this study, an index event is a start of ribociclib+ET treatment. Post-index follow-up period is 24 months or until treatment discontinuation. The recruitment period is planned for 12 months. The interim analyses will be performed after enrollment is complete, and further one year later. Patients will visit the sites in accordance with routine clinical practice. It is assumed according to the clinical practice that visits will be conducted every 3-4 months. Patients will undergo standard procedures and tests according to clinical guidelines and physician's judgement.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 65 years at the moment of ribociclib+ET initiation
2. Female/Male gender
3. Confirmed diagnosis of locally advanced/metastatic not eligible for curative surgery HR+HER2- BC for whom the treating physician took the decision to initiate treatment with ribociclib+IA/FUL in the first or in the second line of the treatment
4. Patient who initiated treatment with ribociclib+IA/FUL no longer than 4 weeks (28 days) prior to written informed consent for this study
5. Provision of written informed consent.

Exclusion Criteria:

1. Patients with a life expectancy of less than 3 months per the investigator's judgment
2. Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study)
3. Patients on active treatment for malignancies other than aBC within 3 years before BC diagnosis
4. Patients with active cardiac disease, or history of cardiac dysfunction, including prolonged QT interval corrected using Fridericia's formula (QTcF \> 450 msec).