cyrilzakka/clinical-trials huggingface dataset:
Use of a Modern Breath Sampling System (the Pneumopipe® Combined With an Array of E-nose Sensors) for the Prediction of Treatment Response in Persistent Asthmatic Children

Due to a large disease heterogeneity, the proper management of childhood asthma may be a challenging task. Despite the screening of lung function is a fundamental tool, spirometry alone may not allow a reliable prediction of the disease prognosis, such as treatment response and asthma exacerbations.

Recently, it has been shown that the detection of volatile organic compounds (VOCs) in exhaled breath (Breathomics) is able to predict asthma exacerbations and to discriminate children with persistently controlled asthma from those with uncontrolled asthma. These studies have been realized through gas chromatography / mass spectroscopy techniques, which also provide information on specific compounds useful for pathophysiologic research; however, they are expensive and time consuming.

An alternative approach, scarcely adopted so far, is based on cross-reactive nonspecific sensor arrays (e-noses), which may provide valuable information on disease status through pattern recognition algorithms or discriminant analyses of the global sensor response pattern (breath-fingerprint). In particular, the Pneumopipe® (European patent 12425057.2, Rome, Italy) is a recent and innovative device allowing direct absorption of VOCs on a cartridge after an individual has normally breathed in it for 3 min. It is a very simple and cheap procedure, suitable for non-collaborative populations. Moreover, cartridges may be preferable over sampling bags in terms of preservation and transportability. This modern breath sampling system provides repeatable measurements, and negligible overlap has been observed with information provided by spirometry.

The main objective of the present study is to assess whether baseline (pre-treatment) spirometry and e-nose measurements may predict asthma prognosis in persistent asthmatic children, in terms of response to the prescribed treatment with inhaled steroid (ICS), and to provide simple rules for discriminating treatment responders and non-responders. The secondary aim is to assess e-nose ability to predict asthma exacerbations, disease control and adherence.


Eligibility Criteria:
Inclusion criteria:

* male or female gender
* age between 6 and 16 years
* first asthma diagnosis according to GINA recommendations (http://ginasthma.org), including assessment of the history of respiratory symptoms (wheezing, shortness of breath, chest tightness and cough) and environmental exposures (smoke, mold, vehicular traffic), spirometry (FEV1/FVC\<0.90 at baseline, \>12% FEV1 increase from baseline after bronchodilator inhalation) and skin prick tests.

Exclusion criteria:

* exacerbations requiring oral corticosteroids in the last four weeks
* use of controller medications (leukotriene receptor antagonists and/or inhaled corticosteroids) in the last four weeks
* respiratory infections in the last four weeks
* immunological, metabolic, cardiac or neurological diseases
* major malformations of the respiratory system
* active smoking.
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Mexico

This is a Mexican, Multicentre, Observational Study to evaluate Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.

Subjects will be enrolled in a multicenter longitudinal observational study. Parents and patients will provide their Informed Consent to upload their data for population-based analyses and optionally to adhere to a patient adherence support program "AUMENTA" designed to improve their adherence and, ultimately, clinical outcomes. Adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. Data will be collected retrospectively and prospectively. This will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. Collected data will be also analyzed in a multinational pooled analysis of comparable national studies.

Primary Objective:

-To assess the level of adherence of subjects receiving SAIZEN® via easypod™

Secondary Objectives:

* To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN® via easypod™
* To identify adherence subject profiling
* To asses the impact of adherence on IGF1 (i.e. above, below or within normal ranges)
* To assess/describe the impact of Mexico patient support program "AUMENTA"

Eligibility Criteria:
Inclusion Criteria:

* Administered growth hormone via the easypod™ electromechanical device according to local Prescribing information
* Over the age of \> 2 years
* Under \< 18 years of age, or over 18 without fusion of growth plates
* Parents' or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parents/guardian may withdraw consent at any time without prejudice to future medical care. If the child is old (over 18 without fusion of growth plates) or able to give written informed consent, a separate assent form will be given
* Patient signed informed consent if has 7-17 years old
* Patient signed informed consent if has 18 years old

Exclusion Criteria:

* Subjects taking growth hormone in whom growth plates have fused (i.e. for taking growth hormone for it's metabolic effects)
* Contra-indications to SAIZEN® as defined in the local prescribing information
* Use of an investigational drug or participation in another interventional clinical study
A Comparison of Saquinavir Hard- and Soft-Gelatin Capsules in HIV-Infected Patients

To compare the antiviral activity, safety, and pharmacokinetics of saquinavir hard gel capsule (HGC) formulation, to 1 of 3 doses of saquinavir soft gel capsule (SGC) formulation administered orally every 8 hours for 4 weeks.

Patients are randomly assigned to one of the four treatment groups as follows:

Group 1: 10 patients receive saquinavir HGC. Group 2: 10 patients receive saquinavir SGC. Group 3: 30 patients receive saquinavir SGC at an intermediate dose. Group 4: 30 patients receive saquinavir SGC at the highest study dose. Upon completion of the initial 4 weeks, all patients may have the option to continue their originally-assigned therapy as monotherapy unless significant drug toxicity intervenes. If the analysis of the initial 4 week data identifies an optimal dose of saquinavir SGC, patients may have the option to change to this optimal dose in a treatment extension phase of the protocol. Patients in this extension phase may choose to remain on monotherapy unless they experience significant drug toxicity, their CD4 count or HIV-RNA levels return to baseline, until saquinavir is approved by the FDA or study termination, whichever comes first.

NOTE: A washout \>= 28 days is required for patients on antiretroviral therapy.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* CD4 count of 100 to 500 cells/mm3.
* Greater than 20,000 HIV-RNA copies/ml.

Exclusion Criteria

Prior Medication:

Excluded:

Prior treatment with protease inhibitors.

Required:

* Less than 8 weeks prior antiretroviral treatment (For at least 25% of patients).
* At least 8 weeks prior antiretroviral treatment (For at least 25% of patients).
EHP-5 in Preoperative Assessment in Women With Endometriosis

There is no validated tool in quality-of-life assessment of women with endometriosis in Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing this questionnaire in clinical practice. After validation, we will prospectively follow women with endometriosis through whole process - pre- and postoperatively.

There is no validated tool in quality-of-life assessment of women with endometriosis in Croatia. First aim is to validate Endometriosis Health Profile-5 (EHP-5) before implementing this questionnaire in clinical practice. After validation, we will prospectively follow women with endometriosis through whole process - pre- and postoperatively, including comparison with rASRM and Enzian score which are already established in our Clinic.

We will try to identify correlation between EHP-5 score and surgical findings and to provide better insight in quality of life consideration of women with endometriosis particularly in Croatia. Since we are tertiary referral centre with almost 250 operative procedures which include ovarian, pelvic and/or extra pelvic endometriosis, we believe that this study will bring new tool not only for preoperative assessment but postoperative surveillance.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 50 years; symptoms of endometriosis (pelvic pain, dyspareunia, dysmenorrhea) for at least 6 months or previously verified primary sterility; pathohistological confirmation of diagnosis after surgical treatment or indicated diagnostic laparoscopy; fluent and literate in Croatian language; ability to independently understand the questions in the questionnaires

Exclusion Criteria:

* pregnant women; cognitive impairment or intellectual disability; neurological disorders (e.g. epilepsy, Parkinson disease, multiple sclerosis, cerebrovascular insult); lack of independent mobility and polytraumatic patients; diagnosed vulvodynia and active vulvovaginitis; ongoing urinary tract infection; any form of prior conservative and/or surgical treatment for endometriosis; lack of informed consent
Effectiveness of Bonding-Based Education Intervention

The study aimed to determine the impact of the Father-Preterm Newborn Bonding Programme (B-PreBAP) on fathers' parenting behaviours, stress levels, and support needs. Additionally, the study aimed to investigate the effect of B-PreBAP on the stress levels of preterm newborns.

This study constitutes a part of the doctoral thesis titled "Development of Father-Preterm Newborn Bonding Model".

Eligibility Criteria:
Inclusion Criteria:

1. Characteristics of the father; Turkish speaking Literate 18+ Open to communication and co-operation Fathers who agree to participate in the study will be included
2. Characteristics of the preterm newborn Hospitalised in the NICU from the first postnatal day Preterm newborns born between 32 and 33 weeks

Exclusion Criteria:

1. Characteristics of the father; Has a diagnosed psychiatric diagnosis Having twin preterm newborns
2. Characteristics of the preterm newborn Intubated
Lenalidomide Combined With Rituximab as Front-line Therapy for DLBCL Patients Aged Over 80 Years

About 40% of Diffuse large B cell lymphoma relapse or is refractory, age is a prognostic factor of DLBCL, as elderly patients are not capable to received standard treatment, the prognosis of elderly patients is poor especially those aged over 80 years. In this study,we aimed to investigate the safety and efficacy of the combination of lenalidomide and rituximab in elderly patients aged ≥ 80 years with untreated DLBCL.


Eligibility Criteria:
Inclusion Criteria:

1. Age≧80 years ;
2. ECOG score 0-2；
3. untreated with pathologically conﬁrmed CD20+ DLBCL ;
4. expected life expectancy of ≥ 12 weeks;
5. capable of swallowing tablets;
6. GFR(by Cockcroft- Gault)≥30 ml/min;
7. can sign written informed consent to participate in the study.

Exclusion Criteria:

1. with CNS involvement;
2. with other malignancy (not including adequate-treated non-melanoma cutaneum carcinoma); patients with other cancer but disease-free for ≥5 years can enter this study;
3. with ≥ grade 2 peripheral neurophathy;
4. with cardiopathy including unstable angia or myocardial infarction over the past 8 weeks;
5. received live vaccine within 28 days.;
6. HIV-positive;
7. thrombosis ;
8. GFR\<30 mL/min;
9. other conditions not suitable for rituximab or lenalidomide application.
Epidemiology of Carotid IMT Progression in MESA - Ancillary Study

To determine the factors associated with progression of sub-clinical atherosclerosis and to evaluate the associations between the progression of sub-clinical atherosclerosis and the development of clinically manifest atherosclerosis.

BACKGROUND:

Cardiovascular disease remains the leading cause of death in the United States and one of the leading causes of morbidity. New technology recently has allowed the non-invasive investigation of the extent of atherosclerosis in different vascular beds. Unfortunately, the clinical implications and significance of this new technology have not yet been fully examined nor has the interrelationship between these various measurements of clinical and sub-clinical atherosclerosis. The study is ancillary to the Multi-Ethnic Study of Atherosclerosis (MESA), an NHLBI-supported epidemiological study of atherosclerosis in several ethnic groups.

DESIGN NARRATIVE:

A longitudinal assessment of the carotid intima media thickness (IMT) will be added to the scheduled follow-up visits in MESA subjects in order to study the relationship between carotid IMT and a measure of calcium burden in the coronary vessels. In addition, studies will be conducted on how these two non-invasive markers of atherosclerosis relate to cardiovascular disease risk factors and clinical events.The study will utilize the MESA cohort involving 6500 subjects who will have baseline and four follow-up examinations. coronary artery calcification (CAC) and IMT are being obtained at baseline, with CAC determinations also scheduled at follow-up. IMT determinations will be added in conjunction with the CAC studies in the second and third exams and detailed analyses will be carried out on these two measures of atherosclerotic burden that may reflect different biologic processes.

Eligibility Criteria:
Members of MESA study
Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection

The purpose of this study is to investigate the role of T helper 17 cells (Th17) in the pathogenesis of MRSA infections.


Eligibility Criteria:
All participant inclusion criteria:

* Greater or equal to 18 years of age
* Willingness to undergo blood draw. Skin biopsy will be requested, but is optional

-AND-

HIV-positive and MRSA-negative Group:

* Documented positive HIV test result
* Negative colonization swabs for S. aureus within 14 days of enrollment
* No evidence of skin/soft tissue infection

HIV-positive and MRSA-Colonization Group:

* Documented positive HIV test result
* History of of colonization with MRSA w/in 14 days of study enrollment

HIV-positive and MRSA Infection Group:

* Documented positive HIV test result
* Skin/soft tissue infection with a positive wound culture showing MRSA within 7 days of enrollment
* MRSA infection is not associated with an intravenous catheter or other nosocomial procedure

HIV Negative groups:

* Same criteria used for the HIV-negative groups as listed above.
* No history of HIV infection.
* Willing to undergo an HIV blood test, which must have a negative result.

Exclusion Criteria:

* Women with positive urine pregnancy test within 7 days of study enrollment
* Women who are within 6 months of being postpartum or who are currently breastfeeding
* Subjects unable or unwilling to complete questionnaires and blood draw.
Practical Alternative to Hospitalization

The investigators test the PATH program to evaluate whether the program allows patients to spend more days at home in comparison to patients who receive regular care. The program will involve patients from Penn Presbyterian Medical Center with a set of diagnoses and will provide patients with enhanced services upon discharge from the emergency department.

The PATH program seeks to provide patients with enhanced services upon discharge from the emergency department, including visiting home nurses, visiting home physical and occupational therapists, scheduled frequent telephone visits with a medical provider, care coordination to arrange outpatient evaluation and testing, social work services, and other services. The purpose of this study is to evaluate whether the PATH program allows patients to spend more days at home in comparison to patients who receive regular care.

The broad goal of this program is to provide patients with a personalized package of enhanced services following discharge from the emergency department. In some cases, patients enrolled in the PATH program are likely to be discharged home regardless of enrollment, but are deemed potentially high-risk for returning to the hospital due to their illness or other factors. In other cases, enrolled patients might otherwise have been hospitalized but decide with their clinician that recovery at home is possible with the increased supervision and care provided by PATH. For all patients, we seek to determine whether PATH is effective in expediting patient recovery from acute illness and reduce the time spent in hospital or nursing facilities.

Eligibility Criteria:
Inclusion Criteria:

* Stable (Patients are deemed stable by ED clinician and PATH clinician per review of vital signs, history, exam, test results, and functional status)
* Have active insurance
* Domiciled at home (Patients must live in the community and not in nursing facility, shelter, or otherwise homeless)
* Safe home environment
* Live in Penn Medicine Home Health (PMHH) geographic catchment if enrolled in PMHH services

Exclusion Criteria:

* Substance use disorder (No active untreated SUD, including alcohol, opioids, cocaine, or stimulants)
* Serious mental health condition
* Police custody
* Homelessness
* Anticipated procedures or surgeries
* IV access (Patients with need for home infusion services or frequent blood testing after discharge must have standard level of IV access)
A Study of WVT078 in Patients With Multiple Myeloma (MM)

The design of a phase I, open-label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent WVT078 alone and in combination with WHG626 in patients relapses and/or refractory Multiple Myeloma (MM)

This first-in-human trial with WVT078 is a dose escalation study whose primary purpose is to characterize the safety, tolerability, and determine recommended dose regimen(s) of WVT078 alone and in combination with WHG626 in subjects with MM who have received two or more standard of care lines of therapy including an IMID, a proteasome inhibitor, and an anti-CD38 agent (if available) and are relapsed and/or refractory to or intolerant of each regimen. In addition, this study will assess preliminary anti-MM response of and characterize the pharmacokinetics and immunogenicity of WVT078 alone and in combination with WHG626. The results of this study will inform the future development of WVT078 alone and in combination with WHG626 as a treatment for relapsed and/or refractory MM.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are relapsed and/or refractory to two or more regimens including an IMID, proteasome inhibitor, and an anti-CD38 agent (if available)

Exclusion Criteria:

* Use of systemic chronic steroid therapy (\>or= 10mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment
* Malignant disease other than being treated on this study
* Active known or suspected autoimmune disease
* Impaired cardiac function or clinically significant cardiac disease
* Treatment with cytotoxic or small molecule antineoplastics or any experimental therapy within 14 days or 5 half-lives whichever is shorter
* Active central nervous system involvement by malignancy or presence of symptomatic CNS metasteses
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)

The investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium (Ca) supplementation in overweight (BMI \> 27) premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and who were deficient in vitamin D as reflected by serum 25-hydroxy (25-OH) vitamin D (serum levels \< 20 ng/mL).

We had hypothesized that in women with PCOS, administering optimal daily doses of vitamin D3, as recommended by the National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of calcium, both per oral (PO), over a three month period will improve their metabolic picture, and possibly hormone profile.

Over the course of the trial, after the first 5 subjects had completed 3 month intervention,we observed that daily 2000IU D3 dosing regime was inadequate in normalizing vitamin D status in the study population; the dosing regimen was therefore modified to include weekly supplementation with 50,000IU D2 in addition to daily dosing with 2000IU D3.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women (ages 18-40 years) with normal thyroid function and prolactin levels.
* PCOS diagnosis based on Rotterdam criteria: presence of at least 2 of the following criteria:

  * oligomenorrhea-menstrual cycles \> 35 day intervals
  * hyperandrogenemia (elevated serum testosterone \[free or total\] \&/or androstenedione levels) or features of hyperandrogenism i.e. acne or hirsuitism \[Ferriman-Gallaway score \> 3\]
  * polycystic ovaries on vaginal ultrasound as defined by ESHRE/ASRM criteria (ovarian volume ≥ 10mL or ≥ 12 follicles of diameter between 2-9mm in at least one ovary)
  * Overweight (BMI ≥ 27 Kg/m2)
  * Biochemical evidence of Vitamin D insufficiency (i.e. serum 25 OHD levels \< 20ng/mL)

Exclusion Criteria:

* Pregnancy
* Known causes of oligomenorrhea other than PCOS, e.g. hypothyroidism/Cushing's Disease/late onset congenital adrenal hyperplasia (fasting 17-alphahydroxyprogesterone levels \< 200ng/dL)
* Use of hormonal treatment (birth control pill/patch/depot medroxyprogesterone/medroxyprogesterone) within 3 months of the study onset.
* Use insulin sensitizers (metformin, sulfonylureas, TZDs, incretins) within 3 months of the study onset.
* Use of lipid lowering agents or medications known to influence insulin sensitivity (e.g. niacin, corticosteroids, beta blockers, calcium channel blockers, thiazide diuretics) or influence serum androgens (estrogen, anti-androgens, androgens) within 3 months of the study onset.
* Known history of renal calculi or current use of Calcium and Vitamin D supplements.
* Spanish Speaking.