cyrilzakka/clinical-trials huggingface dataset:
Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma

This study is as an extension study of SD-004-0765, to assess the safety profile of long-term use of budesonide inhalation suspension in Japanese young children with bronchial asthma. Children completing study SD-004-0765 continued administration of budesonide inhalation suspension as judged by the investigator; the dose is adjusted as appropriate within the range of 0.25 to 1.0 mg per day administered once or twice daily, according to the symptoms.


Eligibility Criteria:
Inclusion Criteria:

- 1. Clinical benefit from continued treatment with budesonide inhalation suspension was expected in patients with bronchial asthma participating in study SD-004-0765, as judged by the investigator(s) at the completion of that study (Visit 11, Week 24), and the patient's caregiver wished the continued treatment with budesonide inhalation suspension A written consent to participate in this study had been obtained from the patient's legal representative (a person who exercises parental authority for the patient, or if no one was applicable, a guardian: in principle, the patient's parent).

3. The patient was younger than 5 years old. Patients aged 5 years could be included in this study if no other effective treatment for the patient's bronchial asthma was available as judged by the investigator(s).

Exclusion Criteria:

-1. Concurrent severe diseases of liver, kidney, heart or other complications. 2. Contra-indications (eg, known or suspected allergy) to budesonide or excipients contained in the investigational product.

3. Other conditions, in which the investigator(s) judges patient's participation in this study inappropriate.
Clinical Sciences Research Proposal- The Effect of Physical Exercise on PCOS Overweight Female Adolescents

The Poly Cystic Ovary Syndrome (PCOS), is one of the most common reasons for subfertility, oligomenorrhea and amenorrhea. With the occurrence of 6-20% of the general adult women population. One of the main criteria of this syndrome is a hyper androgenic state.

More than 50% of women who have PCOS are overweight. In the teenage population, PCOS is common in 5-10% of teenage girls. A recent research has shown that elite athlete teenage girls have higher serum androgen levels, especially in anaerobic types of sport.

The purpose of this experiment is to examine the reaction of teenage PCOS overweight girls towards anaerobic exercise. To determine if their hyperandrogenic state is more adapted to excel in anaerobic exercise compared to teenage overweight girls without PCOS.

30 teenage and young adult females, aged 10-25 years old. The minimum hormonal age for inclusion is menarche. Overweight- with a Body Mass Index (BMI) percentage above 85%, divided into 2 groups: 15 girls with diagnosed PCOS, and 15 girls without diagnosed PCOS, without any other medical comorbidities. Followed at the pediatric endocrinology unit.

The 2 groups would participate in 2 anaerobic tests to evaluate their performances. The data received will be used to evaluate their anaerobic attributes, and for comparison between the 2 groups to determine any differences.

The participants will be asked to refrain from any form of physical exercise during the previous day.

After explanation to the patient and his parent and obtaining an informed consent, the participants will start the tests.

The first test is the Repeated Sprint Test: The participant will run a distance of 40 meters, for 6 repetitions. The optimal running time will be calculated, total running time and the Performance Decrement of the run will be calculated.

After that, there will be a 1-1.5 hours resting phase. The second test is the "Wingate Test"- the participants will be instructed to pedal at a maximal pace for 30 seconds on an ergometric bicycle against a resistance adjusted according to their BMI. The Peak Anaerobic Power, the Mean Anaerobic Power and the Fatigue Index will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* post menarche female
* PCOS diagnosis
* overweight- BMI above 85 percent.

Exclusion Criteria:

* inability to complete the physical activity due to health issues
* Thyroid dysfunction (hyper-, hypo-)
* hyperprolactinemia
* congenital adrenal hyperplasia
Steroid Diabetes in Patients With Kidney Disease

If steroid diabetes is not recognized in time, it will cause irreversible damage to the body. Nephropathy patients are more likely to have steroid diabetes ,the incidence rate up to 25%,due to hypoalbuminemia, high-dose hormone and other reasons, so they need to be closely followed up, identified and intervened in time.

1. Patients with nephrosis who had taken glucocorticoid for the first time were followed up, and those who had diabetes themselves were excluded.
2. Regularly follow up and record information on glucocorticoid medication, medications that have an impact on blood sugar, fasting blood sugar, 2-hour postprandial blood sugar, and glycated hemoglobin.
3. Notify relevant doctors of any cases of elevated blood sugar.
4. The total follow-up time is 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who need to use glucocorticoids due to the following diseases: nephrotic syndrome, Immunoglobulin A nephropathy, membranous nephropathy, Anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis (AAV), systemic lupus erythematosus；
2. Initial daily dose of glucocorticoids greater than or equal to 10mg of prednisolone；

Exclusion Criteria:

1. Patients with diabetes；
2. Those who are unable to communicate through language；
3. Uremic patients；
4. Unable to perform blood glucose monitoring and follow-up as required；
5. Those who have used glucocorticoids within the past 3 months and have accumulated a dose of 10mg or more of prednisone；
6. Participated in other clinical studies。
An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%

The purpose of this study is to determine the cosmetic appearance of metronidazole gel (MetroGel®) 1% with commonly marketed facial foundations.

Evaluate the relationship between treatment with MetroGel® 1% and cosmetic performance with the Subjects' usual cosmetic products. It is expected that the female subjects will be able to use their routine cosmetics after application without affecting the cosmetic product's performance or causing side effects.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with moderate Rosacea (Global Severity Score of 3),
* Subjects willing to stop their current rosacea medication for at least 2 weeks
* Subjects must have an established routine of cosmetics application (e.g. must have been using the same facial foundation for at least 3 months and it is not expected to change during the study)
* Subjects must be willing to use their routine facial foundation and not change products while on study

Exclusion Criteria:

* Subjects who do not routinely wear facial foundation
* Subjects who failed to undergo a washout period of 14 days for the use of topical rosacea therapy, (for example: metronidazole, azelaic acid, sulfacetamide)
* Subjects who are unwilling to stop their current rosacea medications for 2 weeks
Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses

The purpose of this study is to assess if BEPREVE (bepotastine besilate ophthalmic solution) 1.5% will have an effect on contact lens wear in patients with contact lens intolerance due to allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* History of allergic conjunctivitis
* History of contact lens intolerance
* 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.
* Are willing/able to return for all required study visits.
* Are willing/able to follow instructions from the study investigator and his/her staff.
* If a woman capable of becoming pregnant, agree to have urine pregnancy testing performed at screening (must be negative) and agree to use a medically acceptable form of birth control throughout the study duration and for at least one week prior to and after completion of the study. Women considered capable of becoming pregnant include all females who have experienced menarche and who have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy).
* Have signed informed consent approved by Institutional Review Board or Independent Ethics Committee.

Exclusion Criteria:

* Corneal refractive surgery 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.
* Systemic or injected corticosteroids (including oral, parenteral, intravenous, rectal) 30 days;
* Nasal or inhaled or ocular corticosteroids 14 days;
* Nasal or inhaled ipratropium bromide (or atropine), inhaled nedocromil, or nasal, inhaled, or ophthalmic sodium cromolyn 14 days;
* Agents with antihistaminic/anticholinergic activity (e.g. antidepressants, antipsychotics) 14 days;
* Leukotriene pathway modifiers (Accolate, Singulair, Zyflo) 10 days;
* Ocular anti-allergy medications including lodoxamide (Alomide), olopatadine (Patanol/Pataday), emedastine difumarate (Emadine), epinastine (Elestat), levocabastine (Livostin) 7 days;
* Non-steroidal anti-inflammatory ophthalmics including bromfenac (Xibrom), ketorolac (Acular/Acuvail), nepafenac (Nevanac), flurbiprofen (Ocufen), suprofen (Profenal), diclofenac (Voltaren) 7 days;
* OTC ophthalmic decongestant, antihistamine, or decongestant/antihistamine combinations 3 days;
* Other anticholinergic agents 3 days
* Immunotherapy injection 1 day.
Exploring the Intervals in Distributed Laparoscopic Skills Training

The objective of this trial is to investigate if short intervals (1-2 days) between training sessions are more efficient than practicing with longer intervals (6-8 days) between sessions during proficiency-based laparoscopic simulator training. Our hypothesis is that just 1-2 days of break between sessions is optimal for the acquisition of laparoscopic skills and that a shorter interval between sessions is optimal for training.


Eligibility Criteria:
Inclusion Criteria:

- Master's degree medical students, enrolled at a Danish University.

Exclusion Criteria:

* Medical students that have participated in prior studies or similar involving laparoscopic training.
* Performing laparoscopy surgery between the intervention and the retention test 3-5 weeks after.
* No informed consent.
* Does not speak Danish on a conversational level.
* Any disability or injury regarding eyesight and mobility.
PMEI Post-Market Clinical Follow-Up

Confirm safety and performance of passive middle ear implants (PMEIs) in subjects with pre-existing condition which made the implantation of a MED-EL PMEI necessary

Collect retrospective audiological and safety results of PMEI implanted subjects. A post-operative minimum and maximum follow-up period was not defined. The mean of the post-operative follow-up period of all patients was calculated.

Eligibility Criteria:
• Inclusion Criteria: Implanted with a MED-EL PMEI; initial implantation or revision implantation receiving a MED-EL PMEI

• Exclusion Criteria: None
Morphofunctional Lung Analysis by PET and CT After Lung Transplantation

72 hours after lung transplantation, patients undergo a positron emission tomography (PET) scan and a computed tomography (CT) scan in order to analyse lung function and morphology.

Aim of the study is to analyse complications onset (in particular primary graft dysfunction), and evaluate 90 days mortality after lung transplantation.

Pulmonary transplantation is considered as a lifesaving procedure in end-stage pulmonary disease. However morbidity and mortality after lung transplantation are still significant.

Primary graft dysfunction (PGD) is the main cause of early death. PGD is similar to acute lung injury (ALI)/ acute respiratory distress syndrome (ARDS): oxygenation is compromised, pulmonary compliance is decreased, chest Rx shows several infiltrates, and alveolar damage is present.

25% of patients develops PGD within 72 hours from transplantation and 30 days mortality is eight times higher in patients who develop PGD.

72 hours after lung transplantation, patients, whose clinical condition allow to bring them to nuclear medicine department, will undergo pulmonary computed tomography (CT) to study lung morphology and measure lung recruitability and positron emission tomography (PET) to study lung functionality and estimate lung inflammation.

Aim of this study is to investigate the onset of PGD and other complications and to determine 72 hours and 90 days mortality after lung transplantation.

Eligibility Criteria:
Inclusion Criteria:

* lung transplantation
* ≥ 18 years

Exclusion Criteria:

* \< 18 years
* patient' s clinical conditions not allowing patient transport from ICU to Nuclear Medicine Unit
Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders

Injection in the Suprachoroidal space has potential of increasing the efficacy of the drug upto six times with direct effect on retinal tissues sparing the crystalline lens and trabecular meshwork.

A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana with the help of gentle pressure on the sclera will help to inject medication such as triamcinilone or VEGF blockade agents (Ziv aflibercept or Bevacizumab) in the potential Suprachoroidal space which offers direct effect of injected drug on the retina and choroid sparing both crystalline lens, trabecular meshwork and other ocular tissues, hence improving efficacy of the drug upto six times and reduce potential complications such as cataract and glaucoma.

Eligibility Criteria:
Inclusion Criteria:

* 20 years and older
* Patients with macular edema or degeneration from various pathologies
* Central macular thickness more than 250 microns
* Patients who are able to come for all follow-up

Exclusion Criteria:

* Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
* Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
* For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
* Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART)

The purpose of this study is to test an adaptive adherence intervention, which utilizes two mobile health (mHealth) intervention designs, in an effort to promote adherence to antiretroviral therapy (ART) and achieve and maintain viral load (VL) suppression in youth living with HIV (YLH) while increasing understanding of the context for wide-scale implementation of cell phone support (CPS) and text messaging support (SMS), with and without incentives.

The study will consist of two points of randomization. The first step involves randomization of participants to receive either CPS or SMS using a 1:1 allocation ratio. Both intervention conditions will receive 3 months of intervention (i.e., 12 weeks of CPS or SMS).

The second step involves a stratified randomization in blocks with 8 possible intervention trajectories. Within each condition, participants are categorized into two groups - responders with VL\<200 (Rsp) and non-responders with VL ≥200 (NRsp). Responders in the CPS condition will be randomly assigned to receive either 3 months of CPS tapered (CPS-T) intervention followed by standard care (SC) or only SC. Similarly, responders in the SMScondition will be randomly assigned to receive either 3 months of SMS tapered (SMS-T) intervention followed by SC or only SC. Non-responders in both CPS and SMS conditions will be randomly assigned to receive either 3 months of incentivized CPS (CPS-I) followed by 3 months of CPS-T and 3 months of SC or 3 months of incentivized SMS (SMS-I) followed by 3 months of SMS-T and 3 months of SC.

Eligibility Criteria:
Inclusion Criteria:

* HIV diagnosis
* Viral load ≥ 200 copies/mL within 3 months prior to enrollment or self-reported adherence ≤ 80%
* ART medication regimen prescribed minimum of 3 months prior to eligibility VL or self-reported adherence
* Sole owner of device capable of sending/receiving calls and text messages
* Willingness to permit research team to communicate with their HIV care provider team

Exclusion Criteria:

* Mental, physical, or emotional capacity prevents completion of protocol as written
* Inability to understand written/spoken English
* Concurrent participant in any adherence behavioral research intervention
A One-Week Crossover Dispensing Evaluation of New Daily Wear Soft Contact Lenses

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period 1 week compared to nelfilcon A (control).

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 1 week compared to nelfilcon A (control). The primary outcomes of interest is lens fit acceptance.

Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years of age and has full legal capacity to volunteer.
* Is no greater than 55 years of age.
* Has read and understood the information consent letter.
* Is willing and able to follow instructions and maintain the appointment schedule.
* Is an adapted soft contact lens wearer having worn lenses for a minimum of 4 weeks prior to the study.
* Has spectacle cylinder ≤1.00D in both eyes.
* Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
* Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
* Wears CLs in both eyes (monvision acceptable, but not monofit)
* Has clear corneas and no active ocular disease.
* Has not worn lenses for at least 12 hours before the examination.
* Is willing to wear the study contact lenses for a minimum 8 hours per day/6 days per week

Exclusion Criteria:

* Has never worn contact lenses before.
* Has any systemic disease affecting ocular health.
* Is using any systemic or topical medications that will affect ocular health.
* Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
* Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
* Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
* Is aphakic.
* Has strabismus/amblyopia.
* Has undergone corneal refractive surgery.
* Is pregnant, lactating or planning a pregnancy.
* Is participating in any concurrent clinical or research study.
Oxytocin and Attachment-related Interpretation Bias

The purpose of this study is to investigate the effects of oxytocin and a cognitive bias modification (CBM) procedure on children's trust in their mother.

Previous research has shown that children can be trained to interpret ambiguous interactions with mother in a more secure way by use of a CBM procedure. A secure attachment-related processing bias can causally increase children's trust in mother's availability. The present study tests whether intranasal administration of oxytocin can increase the effect of a secure cognitive bias training. Oxytocin is a neuropeptide that is involved in human attachment and bonding. Intranasal administration of oxytocin can increase trust among people. After oxytocin or placebo administration, children are either trained to interpret ambiguous interactions with mother in a secure way or receive a neutral training unrelated to interpretation of maternal behavior. Pre- and post-intervention children's trust in mother, support seeking behavior and interpretation of maternal behavior is assessed. Moreover, possible oxytocin side-effects will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Between 8 and 13 years old
* Mother can also participate

Exclusion Criteria:

* Known oxytocin allergy
* Currently using medication
* Kidney or cardial condition
Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients

This is a prospective cohort study aimed to evaluate change of cardiovascular calcification after parathyroidectomy in patients with end-stage renal disease on dialysis compared with control group on conservative treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years
2. ESRD patients receiving long-term hemodialysis or peritoneal dialysis treatment
3. Severe secondary hyperparathyroidism defined as iPTH level \> 800 pg/ml, followed with hypercalcemia and/or hyperphosphatemia; with presence of one or more nodular or diffuse parathyroid hyperplasia confirmed with CT

Exclusion Criteria:

1. Primary hyperparathyroidosis as a cause of ESRD
Xiyanping Injection Combined With Azithromycin VS Azithromycin for Children With pneumoniaProtozoal Pneumonia

Mycoplasma pneumoniae pneumonia in children is one of the major diseases in children's respiratory department in China, but there are still large clinical unmet needs.

In order to further verify the clinical value and safety of Xiyanping injection in children with Mycoplasma pneumoniae pneumonia, to provide references for subsequent confirmatory research, and to provide more reasonable and standardized application guidance and basis for clinical practice, we intend to adopt more rigorous Scientific design to carry out a multi-center, randomized, double-blind, parallel-controlled study of Xiyanping injection in the treatment of children with Mycoplasma pneumoniae pneumonia.

Eligibility Criteria:
Inclusion Criteria:

1. 5 to 14 years of age at the time of screening;
2. Children who meet the Western medicine clinical diagnosis standard of Mycoplasma pneumoniae and the mycoplasma pneumoniae IgM antibody titer ≥1 : 80, or Mycoplasma pneumoniae DNA or RNA (PCR) test positive, or rapid identification of Mycoplasma pneumoniae antibodies positive;
3. Heat course ≤ 5 days;
4. The total number of peripheral blood routine leukocytes is within the normal range;
5. The child's legal guardian or / and himself voluntarily participate in the study, and the legal guardian agrees and signs the informed consent form (while children ≥8 years of age need to voluntarily sign the informed consent form);
6. According to the researcher's judgment, the subject / legal guardian is believed to be reliable and able to comply with this plan, visit plan and medication arrangement.

Exclusion Criteria:

1. Have a disease that needs to be distinguished from Mycoplasma pneumoniae pneumonia (MPP);
2. Patients with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, abnormal lung development, aspiration pneumonia, lung malignancies, etc .;
3. Congenital abnormalities of heart and lung, combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system, or any laboratory test indicators meet the following criteria: alanine aminotransferase (ALT), aspart Amino acid aminotransferase (AST)\> 2.0 times, serum creatinine (Cr)\> 1.5 times the upper limit of normal value (ULN);
4. Those who have been diagnosed with Mycoplasma pneumoniae in the past 3 months;