cyrilzakka/clinical-trials huggingface dataset:
Topical Gentamicin Nonsense Suppression Therapy of EB

The overall purpose of this study is to address whether topical gentamicin therapy is an effective and feasible treatment. Specifically, we will investigate the effect of non-intensive treatment (once daily or every other day) on skin protein expression, as well as quantify the effect on wound healing in patients with EB caused by PSC (part A). Furthermore, we will address in vitro whether gentamicin restores protein expression of genes affected by SSM in fibroblasts derived from skin biopsies obtained from patients with EB caused by SSM (part B). If these in vitro experiments yield positive results, the patients donating the cells will be offered to enter part A of this study. The overall duration of part A in this study is planned to be 18 weeks per patients and consists of a 6 weeks treatment period followed by a 12 week follow up period. Each patient will attend 3 study visits: at week 0, week 6 and week 18. All patients will be included within a time period of 12 months. The overall duration of part B will be up to 8 weeks per patients of which 4-7 weeks are spent to prepare fibroblasts obtained from skin biopsies. Then 5 days of in vitro intervention and subsequent analysis follows. Altogether, the duration of the GENTELBULL study will be 78 weeks or less.


Eligibility Criteria:
Inclusion Criteria:

1. The patient has EB caused by nonsense mutation
2. The patient has a symmetrical distribution of wounds which allows for wounds on one side of the body to serve as control wounds, while study therapy is applied to the other side.
3. The patient (if an adult) or parent(s)/guardian(s) is capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
4. Women of childbearing potential must use a highly effective contraception method

Exclusion Criteria:

1. Known contact allergy against gentamicin sulfate or other ingredients in the ointment
2. Known intolerance to gentamicin sulfate of any sort
3. Moderate or severely reduced kidney function (eGFR \<45)
4. Use other experimental therapy against EB
5. Receiving systemic aminoglycosides during the last 3 months
6. The patient uses muscle relaxant drug(s)
Clinical Study to Evaluate the Efficacy of the Dietary Supplement UROMANNOSA® in Women With Recurrent Lower Urinary Tract Infections

To analyze the clinical impact of a food supplement composed of D Mannose, cranberry extract (Cran-max) and Vitamin D3 in the prevention of recurrent lower urinary tract infections (UTI)

Once patients have been informed about the study, the potential risks and treatment alternatives, those who meet the selection criteria, agree to participate and sign the informed consent, will be randomly and openly assigned, in a 1:1:1 ratio, to one of the following groups:

Group A: Patients with repeat UTIs who will receive prophylactic treatment for 6 Months.

Group B: Patients with repeat UTIs who will receive prophylactic treatment for 3 Months.

Control group: Patients with recurrent UTIs who will not receive as prophylactic treatment the supplement under study.

The three groups will be treated following standard clinical practice with follow-up at 3, 6, 9 and 12 months after inclusion.

Eligibility Criteria:
Inclusion Criteria:

* History of Recurrent Lower Urinary Tract Infection (at least two episodes in the last 6 months or three episodes in the last 12 months).
* Multiple infections must be spaced a minimum of 2 weeks apart or if less, with a negative urine culture in between.
* Women who agree to participate and give their informed consent in writing

Exclusion Criteria:

* Use of antibiotics or cranberry or other preventive treatment, pharmacological or not, for recurrence of urinary tract infections in the last two weeks.
* Patient with indwelling catheter or intermittent catheterization.
* Patients who present: Interstitial Cystitis, Neurogenic Bladder, Diabetes Mellitus, Nephrolithiasis, Cervical-Uterine Cancer diagnosed and treated less than 5 years ago.
* Use of anticoagulants or contraceptive methods using spermicides or diaphragms.
* Women consuming probiotics or foods, beverages or supplements containing extracts or parts of the genus Vaccinum sp, including other forms of V. macrocarpon (blueberry), V. myrtillus (European blueberry), V.angustifolium (wild or lowbush blueberry), V. corymbosum ( highbush blueberry) or V. vitis-ideae (mountain blueberry), during the two weeks prior to recruitment.
* High consumption of fruits rich in phenolic compounds, with special reference to berries.

Women allergic to berries

* Pregnant or breastfeeding women.
Octylseal Surgical Adhesive in General Surgery

The purpose of this study is to evaluate how surgical adhesive is used.

In this Case Series Study, clinician experience and subject outcomes will be recorded in the use of a topical skin adhesive (Octylseal) on the closure of skin incisions from General surgical procedures.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for use of a topical surgical skin adhesive

Exclusion Criteria:

* Subjects with know sensitivity to topical surgical tissue adhesive products or degrading products (cyanoacrylates or formaldehyde)
* Subjects with a history of keloid formation, hypotension, insulin dependent diabetes mellitus, blood/clotting disorders, peripheral vascular diseases or hypertrophy history
* Subjects who present with a contraindications for product usage as per labeling
* A wound with evidence of active infection or gangrene or wounds of decubitus etiology
* Mucosal surfaces or across mucocutaneous junctions or skin that might be exposed to bodily fluids or with dense natural hair
* Subjects with known hypersensitivity to cyanoacrylate or formaldehyde
Low-dose ITI Strategy for Children in Hemophilia A With High-titer Inhibitor and Poor ITI Risk in China

The study start on January 18, 2017. The Severe(FⅧ\<1%) and moderate hemophilia A (FⅧ1%～5%)children with high titer inhibitor(historical peak inhibitor titer≥5BU ) combining with poor ITI risk(s) were enrolled. The low-dose ITI was alone or combined with immunosuppression.

Poor risk(s) includes:①peak historical inhibitor titer≥200BU ②inhibitor titer≥10BU before ITI initiation ③peak inhibitor titer during ITI≥200BU ④time to titer decline to\<10BU before ITI≥24 months ⑤age≥8 years at start of ITI ⑥ITI initiated ≥5 years after inhibitor diagnosis ⑦interruptions in ITI≥2 weeks in duration. The low-dose ITI strategy consist of FⅧ（25-50IU/kg）alone or combining with immunosuppression: prednisone and Rituximab when the inhibitor titer ≥40BU ml/ml before or during ITI.

Eligibility Criteria:
Inclusion Criteria:

* Males
* from 1 to 14 years old
* severe or moderate hemophilia A;
* inhibitors positive before ITI started.

Exclusion Criteria:

* Females
* \<1 or \>14 years old
* hemophilia B or mild haemophilia A;
* inhibitor negative before ITI started.
Physical and Chemical Study of Atherosclerosis Mechanisms

Study the mechanisms of atherosclerosis based on a comparative study of physical and chemical properties of lipid tissues at various localization with subsequent development of concept of treatment and prevention.

The chemical and physical properties of different lipids of body. The clinical part of the work is a prospective randomized comparative controlled clinical trial of patients with atherosclerotic diseases.

Developed the concept of "limited biological resources" of the body based on the increase in the expenditure of energy reserves of the body, allowing a critical look at overweight.

The role of overweight in the development of atheromatous fat was revealed. The positive results from the weight loss in patients with atherosclerotic disease were drawn. Developed the metabolic concept of atherosclerosis associated with evolutionary aging and conversion of lipids in hard atherosclerotic fat.

Eligibility Criteria:
Inclusion Criteria:

* written informed consent form
* dyslipidemia (HDL \<1.0 mmol / l, triglycerides (TG) in plasma ≥ 1,7 mmol / l or cholesterol ≥ 5,6 mmol /l)
* waist circumference ≥ 94.0 cm in men or ≥ 80,0 cm in women,
* BP ≥140/95 mm Hg or a patient is taking antihypertensive medications,
* fasting glucose ≥ 6,1 mmol / l or the patient is taking hypoglycemic agents,
* the possibility of treatment for 6 months and follow-up for 1 year

Exclusion Criteria:

* Absence of consent form
* Non-compliance of patient to necessary recommendations.
* The presence of mental illness.
* Complete immobilization of a patient (paresis, and paralysis).
Influence of Public Parks on Physical Activity Levels of Diverse Communities

Engaging in physical activity is an important health behavior for maintaining good health and preventing disease. Public parks offer community members readily accessible areas for recreation and exercise. Modifying park programs and facilities to meet the specific needs of community members may encourage people to engage in more physical activity. Furthermore, using feedback from the community might be the best way to determine how park funds should be allocated for modifications. This study will compare two approaches to park programming and will determine which approach is best at increasing physical activity within the community.

Regular physical activity, such as walking, running, or biking, is known to have substantial health benefits. Exercise is important not only in weight management, but also in reducing the risk of certain diseases and promoting psychological well being. In fact, each year about 1.9 million deaths are attributed to physical inactivity, making programs to promote increased physical activity a public health priority. Public parks are easily accessible recreational areas, and they provide beneficial places to implement programs that encourage physical activity among community members. Using information on park use and assessments of community feedback may help improve park outreach, programming, and features aimed to increase physical activity in the community. This study will compare two approaches to park programming and will determine which approach is best at increasing physical activity within the community. The first approach is CBPR, a research program that involves community members in scientific and systematic park assessments that are then analyzed to guide park programming. The second approach simply provides park utilization and community feedback data to park directors to guide park programming.

Park participation in this study will last 1 year. Participating parks will be assigned randomly to one of three conditions:

* Parks assigned to Condition 1 will participate in CBPR, which will include assessments of observations and surveys about park programs and facilities. Anonymous members of the surrounding community will be involved in the assessments, which will be conducted at baseline and Year 1.
* Parks assigned to Condition 2 will receive the director-only condition. These parks will not take part in any assessments, but park directors will be provided with park utilization data, community feedback, and ways to improve park features to increase physical activity.
* Parks assigned to Condition 3 will receive the control condition and will not take part in the assessments or be provided with park utilization data and community feedback.

Administrative data about parks and park functions will also be collected from all participating parks.

Eligibility Criteria:
Inclusion Criteria:

* Neighborhood park with an advisory board
* Park director who is willing to participate

Exclusion Criteria:

* Park that is NOT a neighborhood park
Light Therapy on Major Depression Disorder

Background:

Major depression disorder is a common psychological disease. It is the second-ranked cause of disability worldwide. The pathophysiology is not yet understood. The main theory is monoaminergic theory based on the effect of monoaminergic drugs. Current treatment includes psychotherapy, medication and electroconvulsive therapy. The onset of action for antidepressant is often slow, therefore strategies to improve the outcome are important. Bright light therapy has been found to be effective in reducing the severity of depression not only in seasonal affective disorder but also in other affective disorder. Previous meta-analyses of light therapy for non-seasonal major depression, however, has yielded conflicting evidence for efficacy.

Purpose:

1. To investigate possible imaging biomarkers of major depression disorder
2. To evaluate the effect of light therapy on depression

Materials and Methods:

This prospective study will recruit 100 patients, randomized into 2 study groups: (1) antidepressant plus treatment light, and (2) antidepressant plus placebo light. All patients will accept a thorough psychological evaluation (including Hamilton Depression Rating Scale, Montgomery-Asberg Depression Rating Scale, Clinical Global Impression-Severity and Patient Health Questionnaire-9 items) at baseline and at the 1st, 2nd, 4th, 8th week during the 8-week experiment intervention, by a blind assessor. Morningness- Eveningness Questionnaire-Self-Assessment Version (MEQ-SA) was only evaluated at baseline. Adverse events were evaluated at baseline, 2nd,4th,8th weeks. MRI study will be arranged at baseline and in 4-week experiment.

Predicted Results and Influence:

1. To evaluate the additional effect of the treatment light on depression disorder
2. To compare the difference of functional magnetic resonance imaging(fMRI), structural MRI among the two groups and between the patients with and without treatment effect in order to detect imaging biomarkers.


Eligibility Criteria:
Inclusion Criteria:

1. Fulfill diagnosis of Major depression disorder based on Diagnostic and Statistical Manual of Mental Disorders(DSM-V) for at least 6 weeks and under medication treatment for at least 4 weeks.
2. at least 20 years old
3. Hamilton Depression Rating Scale(HAMD-17) \>= 13
4. No medication change for at least 4 weeks and no medication change will be considered in the next 8 weeks.
5. Agree to participate in this study and sign the permit.

Exclusion Criteria:

1. Seasonal depression disorder
2. Other psychological or neurological disorder
3. Drug or alcohol abuse within 30 days
4. Visual problem
5. Light-induced seizure or migraine
6. Contraindication for MRI study
7. Severe illness and might be admitted in the near future
8. Might have a long trip in the near future
Newly-diagnosed Intermediate/High Risk Pediatric B-cell ALL Protocol

Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I/HR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I/HR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore:

1. The efficacy of two randomized Blinatumomab application scheme on I/HR-ALL as determined by MRD negatvitiy rate.
2. The efficacy of modified mini-hyperCVD + Venetoclax in I/HR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.

The study shown above will lead to the following revisions to the CCCG-ALL2025 I/HR-B-ALL plan, which will be based on the CCCG-ALL2020 plan.

1. After the induction remission phase, all I/HR-B-ALL patients can afford blinatumomab will participate in a blinatumomab+HDMTX randomized controlled trial as consolidation.
2. For patients cannot afford blinatumomab will be treated with venetoclax + modified mini-hyperCVD during the induction phase, then subsequently with CAT as consolidation phase. CAT will removed from induction phase.
3. For patients who received blinatumomab randomization, the CAT+ course was canceled.
4. All patients will continued with 6 cycles of alternated 5-day venetoclax or Dauno-based CCCG-2020 continuous therapy regimen.
5. Adding IgH rearrangement NGS MRD as an evaluation indicator.
6. Adding pharmacotyping study for I/HR B-ALL.
7. Three more bone marrow punctures and IT will be added with the aims to evaluate the CR rate with deepen remission during or after consolidation.

Eligibility Criteria:
Inclusion Criteria:

1. Age older than 1 month to younger than 18 years.
2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.
3. Diagnosis of B-ALL by immunophenotyping.

Exclusion Criteria:

1. Low-risk ALL
2. sIgM+
3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.
4. ALL evolved from chronic myeloid leukemia (CML).
5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction
6. Secondary leukemia
7. Known underlying congenital immunodeficiency or metabolic disease
8. Congenital heart disease with cardiac insufficiency.
9. Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)
Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children

Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission

This study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at Children's hospital Zagreb.

The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections.

The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) probiotic per serving.

The placebo product is an identical product except for the absence of probiotics.

The study includes an intervention period lasting the length of the hospital stay.

The study product will be consumed daily in the morning together with breakfast.

The consumption of the study products will be taken under the surveillance of the physician.

Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of infections will be analyzed based on the information recorded in the CRF.


Eligibility Criteria:
Inclusion Criteria:

* Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb
* Age from 1 year to 18 years
* Signed informed consent by the parents

Exclusion Criteria:

* Immunodeficiency
* Infants from neonatal period until 1 year of age
* Re-hospitalisation (readmission in a hospital within one month)
* Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to hospitalization)
* Neoplasms
* Severe chronic diseases
* Hospitalization shorter than 3 days
Microbes and Respiratory Illnesses

This study is called the Microbes and Respiratory Illnesses (MARI) Study. Children growing up on farms are exposed to many types of microbes that could be beneficial. It is thought that increased exposure to certain types of microbes early in life helps to develop a healthy immune system and reduce the risk for severe common cold illnesses, breathing problems, and allergies.

Respiratory viruses, most notably rhinoviruses (RV), commonly infect school-age children during the month of September and are a well-known exposure for asthma exacerbations. Allergic sensitization is a risk factor for increased viral respiratory illness burden and wheezing. Nasal Airway Epithelial Cell (NAEC) responses to viral exposure show distinct transcriptional programs that differ in individuals with allergies or asthma. There is a growing body of evidence strongly suggesting nasal airway microbial communities enriched in several commensal bacteria are associated with protection from symptomatic RV infections. Metagenomic sequencing from previously collected nasal samples obtained at age 2 years showed distinct microbial communities and function in the Plain Community Cohort compared to farm and non-farm children. How the early life nasal microbial community can impact risk for viral respiratory infection symptoms and NAEC biology remains an important and unresolved question. To address this important question, this proposal includes an observational study to identify patterns of nasal airway gene expression among three cohorts of school-age children that markedly differ in their susceptibility to respiratory illnesses and wheezing: children from Plain/Amish communities, suburban children without asthma, and suburban children with asthma.

Eligibility Criteria:
Inclusion Criteria:

1. Participant and/or parent guardian must be able to understand and provide informed consent
2. Children ages 4-12 years of age
3. Cohort 1: Family is self-identified as Plain community member
4. Cohort 2: Madison-area children with parental report of doctor-diagnosed asthma
5. Cohort 3: Madison-area children with no history of asthma by parental report
6. Cohort 4: Madison-area children who have an active respiratory illness

Exclusion Criteria:

1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol
2. Chronic sinusitis (frequent sinus infections)
3. Plans to move out of the area before completing the study
4. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
5. Enrolled family member
Unipolar vs. Bipolar Hemostasis in Total Knee Arthroplasty: A Prospective Randomized Trial

The use of Aquamantys during total knee arthroplasty will reduce drain output and the necessity for blood transfusions.


Eligibility Criteria:
Inclusion Criteria:

* Patient indicated for total knee arthroplasty

Exclusion Criteria:

* Patients undergoing revision total knee arthroplasty
* Patients with blood disorders
* Patients on chronic anti-thrombotic medication such as Coumadin
* Patients with a history of deep vein thrombosis
* Patients with a history of pulmonary embolism
Study to Assess Safety and Tolerability of EO2002

The goal of this clinical study is to assess the safety of intracameral injection of EO2002 in subjects post-cataract surgery.


Eligibility Criteria:
Key Inclusion Criteria:

1. Age ≥ 18 years.
2. Subject has uncomplicated history of cataract that has progressed to a level requiring standard cataract extraction with intraocular lens implant surgery.
3. Decreased endothelial cell count

Exclusion Criteria:

All ocular criteria apply to study eye unless otherwise noted.

1. Other corneal disease
2. Macular disease that in the investigator and/or sponsor's opinion would limit the ability of the subject to demonstrate improvement in BCVA.
3. Descemet membrane detachment.
4. History of uveitis or other ocular inflammatory disease.
5. History of incisional glaucoma surgery
6. Prior incisional eye surgery within 3 months prior to study treatment or penetrating or endothelial keratoplasty.
7. History of ocular neoplasm.
8. ETDRS BCVA in the fellow eye is worse than 35 letters (Snellen equivalent of 20/200).
9. Female who is pregnant, nursing, or planning to become pregnant, or who is of childbearing potential and not using a reliable means of contraception during the study.
10. Subject is currently participating in or has participated within the last 3 months in any other clinical trial of an investigational drug by ocular or systemic administration.
11. Any concomitant medical or psychological condition that could interfere with study participation or is otherwise not suitable for entry into the study in the opinion of the investigator.