cyrilzakka/clinical-trials huggingface dataset:
Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT)

The objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of Olea europaea in the rhinitis or allergic rhinoconjunctivitis

Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with two arms of treatment: placebo and active.

Eligibility Criteria:
Inclusion Criteria:

* Positive suggestive clinical history of allergic seasonal rhinitis or rhinoconjunctivitis
* Patients of both gender \> 18 years old
* Positive prick test results using non modified Olea europaea allergen extract (wheal size \> 3mm2)
* Specific IgE to Olea europaea
* Written informed consent

Exclusion Criteria:

* Use of immunotherapy during the last four years.
* Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria:
* Treatment with ß-blockers
* Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
* Patients suffering from immune deficiencies
* Patients with serious psychiatric / psychological disturbances
* In addition, the following was considered as exclusion criteria:
* Pregnant or/ in lactation patients
* Patients aspirin intolerance
A Dose Response Trial to Evaluate Clinical and Mycological Effect of Nitric Oxide in Subjects With Tinea Pedis

A multi-arm trial to evaluate the efficacy and safety of using gaseous nitric oxide to treat moderate to severe tinea pedis.


Eligibility Criteria:
Inclusion Criteria:

* Positive clinical findings (moderate to severe, indicated by a CSSS ≥ 6) for interdigital or bullous tinea pedis as determined by clinical examination (subjects with moccasin symptoms in addition to above may also be included at the discretion of the investigator).
* Written informed consent must be obtained from the subject.
* Must ≥ 18 years of age, unless local laws dictate otherwise.
* Must agree to avoid professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit until the conclusion of the trial.
* Must not be pregnant or nursing, and if of childbearing potential, agree to take measures to avoid pregnancy during the study period

Exclusion Criteria:

* Has a diagnosis of either psoriasis or eczema, in or immediately around the area under evaluation.
* Has a visual diagnosis, by the investigator, of onychomycosis at a level, which in the opinion of the investigator would compromise the integrity of the study.
* Use of topical antifungals e.g. (clotrimazole, ketoconazole,miconazole, oxiconazole- (Oxistat®, Glaxo Smith Kline), sulconazole, naftifine (Naftin®, Merz), terconazole, econazole nitrate (Spectazole®, Ortho-McNeil), butoconazole ,Fluconazole, ciclopirox olamine-(Loprox®, Medicis), tolnaftate, haloprogin), Zeasorb-AF , antibacterials and corticosteroids in the preceding 14 days of screening visit (Day 1), on or immediately around the area under evaluation.
* Use of oral or injectable systemic corticosteroids in the preceding 7 or 30 days respectively, of screening visit (Day 1)
* Use of systemic antifungals in the preceding 30 days of screening visit (Day1) including - (terbinafine - (Lamisil®, Novartis), Itraconazole - (Sporanox®, Janssen), fluconazole- (Diflucan®, Pfizer), ketoconazole, miconazole, griseofulvin (Gris-PEG®, Pedinol), butoconazole, terconazole, Potassium iodide)
* Has used any investigational drug(s) within 30 days preceding screening visit (Day 1)
* Is pregnant or is a nursing mother
* Is a woman of child bearing potential who is not using an adequate form of contraception (or abstinence)
* Is \< 18 years of age, unless local laws dictate otherwise.
* Is immunosuppressed (undergoing chemotherapy, neutropenia (PMNs , \< 500/mm3), HIV with CD4+ \< 200/mm3.
* Suffers from a condition, which, in the opinion of the medical investigator, would compromise his/her safety and / or the quality of the data. Such conditions may include collagen vascular disease, diabetes mellitus, Cushing's Disease, hematological malignancy, chronic mucocutaneous candidiasis or atopy STATISTICS This clinical evaluation is intended to demonstrate
An Observational Study Examining the Use of Triple Combination Therapy With Boceprevir, Peginterferon Alfa-2a and Ribavirin in the Re-Treatment of Chronic Hepatitis C Patients

This prospective, national, multicenter, non-interventional study examined the use of triple combination therapy with boceprevir, pegylated interferon (peginterferon) alfa-2a and ribavirin in re-treating participants with genotype 1 chronic hepatitis C (CHC) infection. Dosing and treatment duration were at the discretion of the investigator in accordance with local clinical practice and local labeling. Participants were to be observed for the duration of their triple combination therapy and for up to 24 weeks thereafter.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or over
* Genotype 1 CHC infection
* Prior unsuccessful treatment with peginterferon alfa plus ribavirin (null-response, partial response and relapsed participants)
* Receiving triple combination therapy with boceprevir, peginterferon alfa-2a and ribavirin according to standard of care and in line with local labeling
* Enrollment in the study no later than 4 weeks after start of triple combination therapy (including peginterferon alfa-2a and ribavirin lead-in phase)

Exclusion Criteria:

* Naïve participants not responding to peginterferon alfa plus ribavirin at week 4 (HCV RNA drop \< 1 log10) or at week 12 (HCV RNA \>/= 15 international units/milliliter \[IU/mL\]) and switching to triple combination therapy with boceprevir
Cytokines of Patients With Transversus Abdominis Plane Block After Laparoscopic Colonic Surgery

The investigators designed a study to determine whether with combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokines in patients undergoing Laparoscopic Colonic Surgery.

The investigators designed a study to determine whether combined general-transversus abdominis plane block anesthesia or standard general anaesthetic would provide same level of cytokine in patients undergoing Laparoscopic Colonic Surgery.

Eligibility Criteria:
Inclusion Criteria:

* •Participants were deemed eligible if they were candidates for spinal anesthesia undergoing Laparoscopic Colonic Surgery

Exclusion Criteria:

* •Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24 (of the 30 possible points)

  * A history of neurological and psychiatric diseases including stroke, and psychosis
  * Severe visual or hearing impairment
  * Unwillingness to comply with the protocol or procedures
IT Enhanced Peer Integrated Collaborative Care for US Trauma Care Systems

This study evaluates two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in US trauma care systems. The two approaches to be compared are a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists to trauma surgical team notification of patient emotional distress with recommended mental health consultation. The collaborative care intervention will be supported by a novel Emergency Department (ED) health information exchange technology platform.

Collaborative care models are an established standard of care for treating combined mental health and chronic medical conditions in acute and primary care medical settings. However, very few interventions exist for the acute injury population transitioning between settings. While peer interventionist programs have been instituted for care delivery in many conditions, they have not yet been comprehensively integrated into acute post-injury interventions. Literature reviews support the need for comparative effectiveness trials of health care system interventions targeting high need injured patients with multiple complex mental health and medical comorbidities who are at risk for fragmented post-injury health service utilization. This study evaluates two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in US trauma care systems. The two approaches to be compared are a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists to trauma surgical team notification of patient emotional distress with recommended mental health consultation. The collaborative care intervention will be supported by a novel Emergency Department (ED) health information exchange technology platform.

Eligibility Criteria:
Inclusion Criteria:

* Inpatient/emergency admission for intentional and/or unintentional injury
* Score of ≥35 on the PTSD checklist
* Endorsement of ≥ 1 severe posttraumatic concern

Exclusion Criteria:

* Patients who required immediate psychiatric intervention
* Patients who are not Washington or Oregon State residents
* Patients who are currently incarcerated
* Patients not speaking Spanish or English
The Influence of Probiotics in a Drinkable Yogurt on Skin Health

The aim of this study is to test if probiotics administered to healthy female subjects in a dairy format have any skin health benefits.

This is a placebo-controlled, double blind, randomized, single center, human clinical trial aimed at assessing the influence of probiotics on skin health in healthy female subjects, when administered in a food matrix over a period of 5 months.

It will consist of five groups(40 subjects/group). The first group (1) of subjects will receive acidified milk that does not contain bacterial strains. The second group (2) will receive acidified milk that contains one specific probiotic strain. The third group (3) will receive fermented milk that contains a standard mix of yogurt bacterial strains. The fourth group (4) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 plus the same specific probiotic strain as in group 2. Finally, the fifth group (5) will receive fermented milk, containing the same standard mix of yogurt bacterial strains as in group 3 and 4 plus the same specific probiotic strain as in group 2 and 4 plus a mix of antioxidants.

This study will address whether:

A.The bioefficacy of a specific probiotic strain is influenced by a milk matrix.

B.Whether other bacterial strains impact the bioefficacy of this specific probiotic strain, and validate whether or not the bioefficacy is related entirely to the activity of this specific probiotic strain.

C.Whether nutritional supplements impact the bioefficacy of a specific probiotic strain.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women as assessed by medical history and standard medical examination
* Caucasian
* Age: 25-55 y (inclusive)
* Normal BMI ≤ 30
* Skin type 1-111
* Regular Hormonal Cycle
* Having given his/her written informed consent
* Willing to avoid the consumption of fermented dairy products
* Minimum consumption of dark chocolate during the period of the study

Exclusion Criteria:

* Smoker
* Pregnant or lactating women
* Post menopausal women
* Heavy alcohol intake (usually consuming more than 3 standard drinks/day)
* Intake of chronic medications except oral contraceptive
* Vitamin and/or mineral and/or antioxidant supplementation over the 3 months preceding the initiation of the study and throughout the study.
* Having skin cancer or genetic disposition to skin cancer
* Regular exposure to artificial UVR
* Daily exposure to sun more than one week over the 2 months preceding the initiation of the study
* Planned vacation to sun during the period of the study.
* Excessive tea drinkers (more than 2 cups a day of green or black tea).
* Excessive consumer of fermented dairy products (more than 150g per day).
* Excessive consumer of dark chocolate (\> 25g per day).
* Regular high exercise such as a marathon
* Subject who regularly takes saunas (dry or wet) or swims daily.
* Subject who cannot be expected to comply with treatment
* Currently participating or having participated in another interventional clinical trial during the last 3 months prior to the beginning of this study.
Trabeculectomy With MMC Versus Ahmed Glaucoma Implant for Treatment of Pediatric Aphakic Glaucoma

In this randomized clinical trial we compare trabeculectomy with mitomycin-C (T+MMC) and Ahmed glaucoma implant (AGI) in treatment of aphakic glaucoma in children under 16 years of age.Complete and qualified success were defined as 5≤IOP≤21mmHg without and with medication respectively and we came to this point that; T+MMC and AGI are comparable in terms of success rate and complications in pediatric aphakic glaucoma.


Eligibility Criteria:
Inclusion Criteria:

* congenital cataract
* history of cataract surgery
* under 16 years old
* Ocular pressure more than 21 mmHg

Exclusion Criteria:

* interruption of the follow up before 6 month
* Anterior segment dysgenesis
School-Based Telemedicine Enhanced Asthma Management

This project aims to improve guideline-based asthma care using enhanced communication and screening tools, telemedicine and directly observed therapy of preventive medications in city schools. Web-based screening will be used to identify children with persistent or poorly controlled asthma and to send reports to the child's primary care doctor. Children in the SB-TEAM group will receive a telemedicine asthma assessment in school and be prescribed a daily preventive asthma medication to be taken through school-based directly observed therapy. The overall aim of this study is to evaluate the use of the SB-TEAM intervention for improving guideline based care, enhancing adherence to effective preventive medications and at reducing morbidity among young urban children with asthma.


Eligibility Criteria:
Inclusion Criteria:

1. Physician-diagnosed asthma (based on parent report)
2. Persistent asthma or poor asthma control (based on NHLBI guidelines). Any 1 of the following:

   * In past month, \>2 days per week with asthma symptoms
   * \>2 days per week with rescue medication use
   * \>2 days per month with nighttime symptoms
   * \>=2 asthma episodes during the past year that required systemic corticosteroids.
3. Age \>=3 and =\<10 years
4. Attending school in Rochester City School District preschools or elementary schools

Exclusion Criteria:

1. Inability to speak and understand English or Spanish
2. No access to a phone for follow-up surveys
3. Family planning to leave the district within fewer than 6 months.
4. The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
5. Children in foster care or other situations in which consent cannot be obtained from a guardian.
Epigenomic and Machine Learning Models to Predict Pancreatic Cancer

The goal of the multicentric and interdisciplinary IMAGene project is to pursue early diagnosis for Pancreatic Cancers in high-risk asymptomatic subject groups, by developing and validating a comprehensive cancer risk prediction algorithm (CRPA) as a clinical support tool to calculate a personalized risk profile.

The study is a longitudinal, non-randomized exploratory clinical study. A total of 170 asymptomatic first-degree relatives of PC patients.

The study is a longitudinal, non-randomized exploratory clinical study. A total of 170 asymptomatic first-degree relatives of PC patients.

The study population consists of 170 first (1st) degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer, where the patient satisfies one OR more of the following conditions:

* was diagnosed with pancreatobiliary cancer \<50 years of age;
* was diagnosed with pancreatobiliary cancer \>50 years of age AND personal history of any solid cancers.

The CRPA will be assessed in 170 first degree relatives of PC patients, in whom the development of pancreatic cysts will be assessed by WB-MRI at baseline and at one year.

Eligibility Criteria:
Inclusion Criteria:

* 1st degree healthy/asymptomatic relatives of patients with exocrine pancreatic cancer, where the patient satisfies one OR more of the following conditions:

  * was diagnosed with pancreatobiliary cancer \<50 years of age;
  * was diagnosed with pancreatobiliary cancer \>50 years of age AND personal history of any of the following cancers: Breast cancer, Ovarian, fallopian tube or primary peritoneal cancer, Melanoma, Colorectal cancer, Endometrial cancer, Prostate cancer, Oesophagogastric cancer, Urinary tract cancer, Small bowel cancer, Brain tumour, Sebaceous skin tumour;
  * was confirmed diagnosis of any of the following conditions in the family: Hereditary Breast and Ovarian Cancer, Peutz-Jeghers syndrome, hereditary pancreatitis, Lynch Syndrome, Familial Atypical Multiple Mole Melanoma Syndrome;
  * significant family history in first degree relatives for cancer (e.g. two or more cancers in one individual or the same cancer in more individuals;
  * a single 1st degree relative with pancreatic cancer;
  * being a patient alive after 5 years from diagnosis (cancer free or currently treated).
* Cancer free at the time of enrollment;

Exclusion Criteria:

* Individuals with comorbidities that adversely influence their ability to tolerate the screening procedures or the screen-detected findings, or tolerate treatment of an early- stage screen-detected cancer, or that limit their life expectancy.
* Subjects already diagnosed with cancer currently in treatment;
* Subjects who are already in the process of clinical assessment or included in a screening program for a suspected tumour.
* Contraindications for the Whole-Body Magnetic Resonance Imaging (WB-MRI) radiological exam
A 2-part Study Consisting of Multiple Ascending Dose (MAD) Safety Study, and a Dose-finding Masked Study to Assess the Safety and Efficacy of Intravitreal (IVT) EYE103 in Patients With Diabetic Macular Edema (DME) or Neovascular Age-related Macular Degeneration (NVAMD)

EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.

In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.

In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.

EYE103-101 is a 2-part study assessing safety and preliminary efficacy of EYE103 in patients with diabetic macular edema (DME) given as monotherapy or neovascular macular degeneration (NVAMD) given in combination with anti-VEGF.

In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE103 will be assessed at escalating doses. Approximately 12 participants will be entered in this part of the study.

In the second part of the study, called the dose finding part two doses of EYE103 will be selected and their effectiveness will be compared. Approximately 80 participants will be entered in this part of the study.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
* DME patients must be ≥ 18 years of age, NVAMD patients must be ≥ 50 years of age
* Diagnosis of either DME or NVAMD. DME patients must be treatment naïve. NVAMD patients can be either treatment naïve or treatment experienced.
* DME patients must have vision loss in the study eye
* NVAMD patients can be either treatment-naïve or treatment experienced with vision loss in the study eye

Exclusion Criteria:

* Be pregnant or breastfeeding
* History of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) within 3 months of Screening
* Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 2 months of Screening
* Any other condition except for DME or NVAMD or that could affect interpretation of study assessments
Electrical Stimulation in Women With Pelvic Organ Prolapse

The aim of this study is to search the effects of electrical stimulation on clinical symptoms such as pelvic floor muscle strength, stage of POP, symptoms of pelvic floor, quality of life and sexual function in women with pelvic organ prolapse (POP)

This study is planned as a prospective, sham radomized controlled study. Individuals who volunteered to participate in the study, complying with the inclusion criteria and signed the consent paper will be randomly allocated into ES and Sham ES groups.

The study includes women aged 18-65 diagnosed with staged 1-2 POP by the physician.All patients were evaluated by the same doctor who performed the POP-Q measurement, who was blinded to the baseline results. The treatment of patients will be given by the same therapist. Measurements will be made 3 times at baseline (before treatment), interim period (4th week) and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Being in the age range of 18-65 ,
* Having stage1-2 symptomatic prolapse according to the POP-Q system,
* Being a volunteer and literate

Exclusion Criteria:

* Being pregnant,
* being stage 3-4 prolapse, Those whose evaluation parameters are missing and who do not regularly participate,
* Inadequate understanding and cooperation in treatment and evaluation parameters,
* Have malignant disease, urinary infection,
* accompanying neurological disease, diabetes mellitus and cardiopathy with complications,
* have electronic and metal implant, loss of sensation, sacral peripheral nerve lesion
* Patients with at least one of the kidney failure requiring hemodialysis
Remotely Monitored Exercise Program in Pregnant Women With Obesity

Pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored

Pregnant women with obesity will be invited to participate in structured home-based exercise programme, remotely monitored. The remote system use inertial motion trackers, digitizes pregnant women motion and provides real-time feedback on performance through a mobile app. It also includes a web-based platform that allows the clinical team to prescribe, monitor and adapt the exercise program remotely. This way, the system allows patients to perform independent exercise program at home without the need for constant therapist supervision, ensuring remote monitoring throughout the rehabilitation program. The exercise programme will be performed since the first gestational trimester until delivery.

Data of gestational weight gain, gestational diabetes mellitus, low back pain and quality of life will be colected.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with obesity (BMI ≥ 30 kg/m2) at first gestational trimester

Exclusion Criteria:

* pre-pregnancy BMI \< 30 kg/m2;
* previous bariatric surgery;
* hemodynamically significant heart disease;
* restrictive lung disease;
* incompetent cervix or cerclage;
* multiple gestation;
* persistent second- or third-trimester bleeding;
* placenta previa after 26 weeks of gestation;
* premature labor during the current pregnancy;
* ruptured membranes;
* preeclampsia or pregnancy-induced hypertension;
* severe anemia;
* inability to read and understand Portuguese; -\>15 weeks gestation.