cyrilzakka/clinical-trials huggingface dataset:
Bexarotene With Narrow-Band UVB for Psoriasis

To determine if bexarotene gel with NBUVB phototherapy is more effective than placebo plus NBUVB for moderate to severe plaque-type psoriasis.

Subjects will be applying active gel or placebo to target lesions to each side of the body in a blinded manner. They will start at three times a week and increase to daily or even twice a day regimen if tolerated. After 2 weeks of application, NBUVB will be added to treatment regimen (whole body, three times a week). Total study time is 10 weeks.

Eligibility Criteria:
Inclusion Criteria

* Patient must be a male or female aged 18 years or older
* Patient must have moderate to severe psoriasis vulgaris of at least 3% body surface area involvement
* Patient must have failed prior topical therapy
* Patient must be willing to minimize sun exposure, to use sun blockers if deemed necessary by the Investigator and to avoid use of tanning booths or other ultraviolet (UV) light sources
* Women of childbearing potential must have a negative urine ß-HCG pregnancy test with a sensitivity of at least 50 mIU/mL within seven days prior to starting of study gels and repeated every four weeks while patient remains on the study gels. All females of childbearing potential must agree to use 2 effective contraceptive methods or remain sexually abstinent one month prior to initiation of study drug, during the entire study period, and for one month after the last application of Targretin® gel 1%. Acceptable methods of birth control include: condoms with spermicide; diaphragm with spermicide; cervical cap with spermicide; spermicidal sponge; intrauterine device (IUD), oral contraceptives, Depo-Provera; contraceptive implants; vasectomy; or abstinence.
* Male patients must agree to use condoms with sexual partners of childbearing potential during the entire period of treatment and for at least one month after treatment is discontinued.
* Patients who are not sexually active and are not using contraception, must agree to use an approved method of contraception (as described above) should they become sexually active during the study

Exclusion Criteria

* Failure to understand the consent form
* Inability to comply with protocol requirements
* Pregnancy
* Inadequate birth control method
* Lactation
* Contraindication to use of topical retinoids
* Concomitant psoriasis therapies except for emollients and OTC shampoos
* Systemic psoriasis therapies, systemic Vitamin A in doses \> 15,000IU/day, PUVA, (psoralen plus ultraviolet A irradiation), UVB, topical psoriasis therapies (other than emollients and OTC shampoos), other retinoid class drugs or investigational drugs within the past 1 month
* Current skin cancer
* History of previous melanoma
* History of skin sensitizing diseases (such as SLE)
* Concurrent medical illness that would make participation in this clinical trial ill-advised
* Patient unwilling or unable to avoid prolonged exposure to the sun or other UV light sources
Fibroblasts and Thoracic Aortic Aneurysms: in Vitro Characterization in with Marfan Syndrome and Genetic Aortic Diseases

The aim of the present study is to characterise the phenotype of fibroblasts and to classify different mechanisms involved in the onset and progression of TAAD in syndromic and non-syndromic subjects in order to evaluate potential markers related to TAAD.

The aim of the study is to analyse cutaneous fibroblast properties in patients with thoracic aortic aneurysms (both syndromic and non-syndromic) to identify differences in molecular mechanisms in collagen turnover pathways compared to healthy controls in the general population.

Eligibility Criteria:
Inclusion Criteria (general for the study):

signed informed consent; subjects aged 18 years and above.

Inclusion Criteria (Case):

subjects with Marfan syndrome and thoracic aortic aneurysms (in clinical follow-up or with cardiac surgery program); subjects with non-syndromic thoracic aortic aneurysms (in clinical follow-up or with cardiac surgery program);

Inclusion Criteria (healthy controls):

absence of any aortic/thoracic disease;

Exclusion Criteria (all groups):

* Presence of any confounding cardiovascular risk factor (hypertension, dyslipidaemia, diabetes, smoking habits) or previous cardiovascular disease
* Corticosteroid or Steroids or Fluorochinolones treatment within six months before enrollment Subjects on chronic immunosuppressive therapies such as oral steroids, but also on chronic topical steroids in the area of investigation;
* A history of keloid formation (data found in anamnesis and medical records);
* Anaesthetic drug allergy (data found in anamnesis and medical records).
Phase II Study of Cisplatin Plus Epirubicin Salvage Chemo in Refractory Germ Cell Tumors

This study proposes to evaluate the combination of cisplatin plus epirubicin in patients with refractory germ cell tumor not amendable to cure with surgery or standard platinum salvage chemotherapy. This regimen will be used in eligible patients after progression on ECOG Study E39897.

To determine the feasibility and toxicity of combining epirubicin to fixed does cisplatin; to determine the partial and complete response rate and duration of remission; to determine the toxicity; to ascertain the potential for greater than 12 month continuous disease-free survival and, therefore, potential curability.

Eligibility Criteria:
Inclusion Criteria:

* histologic or serologic proof of metastatic germ cell neoplasm(gonadal or extragonadal primary) w/ disease not amenable to cure with either surgery or chemotherapy. Pts w/ seminoma \& non-seminoma are eligible, as are women w/ ovarian germ cell tumors.
* Must have failed initial cisplatin combination therapy administered w/ curative intent. In addition, pts should have failed and demonstrated progressive disease following the administration of at least one "salvage" regimen for advanced germ cell neoplasms unless they have primary mediastinal nonseminomatous germ cell tumor, or are considered to be a late relapse (\>2 yrs since becoming a complete response).
* Pts must have adequate system function (WBC\>/= 4,000 \& plts \>/=100,000; SGOT \</=4x normal; bilirubin \</=2.0; serum crt \</=2.5) obtained \</= 4 wks prior to entry.
* ECOG performance status of 0,1, or 2.
* Pts must be at least 3 weeks post major surgery, radiotherapy, or chemotherapy, and have recovered from all toxicity.
* Exclusion Criteria:
* Active, unresolved infection and/or are receiving concurrent treatment w/ parenteral antibiotics. \*Eligible after antibiotics have been discontinued for at least 7 days.
* Pregnant or lactating
* Progression w/in 4 wks of lst course of cisplatin combination chemotherapy.
Biomarkers and Inflammation in Solid Organ Transplantation: Relationship With Short- and Long-Term Outcomes

This is a prospective, tissue-based, low-risk, non-pharmacological study that will include adult patients undergoing solid organ transplantation (heart, liver, lung, kidney) followed at the following Units of the IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO):

* Heart Failure and Transplants (heart-lung)
* Internal Medicine for the Treatment of Severe Organ Failures (liver)
* Nephrology, Dialysis, and Transplantation (kidney).

The aim of this study is to perform objective biological measurements of inflammation and cellular senescence (i.e., plasma profiles of cytokines, inflammatory miRNAs, circulating free DNA, extracellular vesicles), immunosenescence (i.e., circulating and tissue-based leukocyte profiles of aging), and systemic and tissue aging (i.e., epigenetic clocks) in the collected cohort. These measures may help to stratify patients at higher risk of transplant failure (graft damage) or those at higher risk of cardiovascular, renal, metabolic, neoplastic complications, or increased mortality. Additionally, the study aims to implement therapeutic or prophylactic measures based on biological stratification to prevent the progression of biological damage.

It is also important to highlight that the identification of markers of cellular senescence, immunosenescence, and epigenetic aging in the recipient could define patterns that guide more appropriate and personalized immunosuppressive treatments.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥ 18 years old at the time of enrollment) who have undergone at least one of the following: Liver transplant, Kidney transplant, Heart transplant, Lung transplant during the study period.
* Informed consent acquisition.

Exclusion Criteria:

* none
Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Out of 30,000 new cases per year in France, 30% of epileptic patients are drug-resistant. Neurosurgery, which consists in resecting the epileptogenic zone, is the only chance of cure. In the case of temporal epilepsy of the language-dominant hemisphere (TLE), this procedure presents a high risk of increasing cognitive difficulties and may even be contraindicated for this reason alone. The difficulties found are impairments in lexical access (anomia) and verbal memory and affect more than 60% of patients . Preoperative cognitive rehabilitation could influence brain plasticity mechanisms but there are currently no recommendations on this topic. In this context, the investigators have developed a speech rehabilitation procedure specific to the needs of ELTPR patients. They rely on cognitive hypotheses explaining the disorders but also on models of rehabilitation-induced neural plasticity likely to improve cognitive reserve before surgery. The investigators hypothesize that preoperative cognitive language rehabilitation in ELTPR patients may decrease surgical risk and improve postoperative language prognosis.

The primary objective is to demonstrate the protective efficacy of preoperative speech rehabilitation on language performance postoperatively.


Eligibility Criteria:
Inclusion Criteria:

1. Patient 16 years of age and older,
2. Patient whose epileptogenic area involves the temporal structures of the hemisphere specialized for language,
3. Patient whose hemispheric specialization for language is known
4. Patient willing to undergo resective surgery such as anterior temporal lobectomy or resection in the temporal lobe involving the hippocampus and/or the baso-temporal language area and whose planned surgery date is compatible with the performance of the study,
5. Patient with a known NTB score
6. Patient who has signed an informed consent or patient whose parents or legal guardians have signed the informed consent (or a single parent or legal guardian if applicable)
7. Patient whose first language is French (1st language learned by the patient),
8. Patient declaring to be familiar with the use of a computer and having access to an internet connection from home
9. Patient affiliated or benefiting from a social security system.

Exclusion Criteria:

1. Patient with a speech disorder that may impair intelligibility and compromise the use of the interface;
2. Patient with an uncorrected hearing impairment,
3. Patients with a total intelligence quotient (IQ) \<70 (assessed in the context of care, in the year preceding the surgical procedure)
4. Patients who are pregnant, nursing, deprived of liberty, under guardianship or curatorship.
Primary Care Referrals to Community-based Lifestyle Programs for Management of Obesity

The purposes of this study is to evaluate the feasibility of providing a community based referral to Mayo Clinic Employee and Community Health patients for weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are between 18-65 years of age
* Patients who have a BMI between 25-39.9 kg/m2
* Ability to provide informed consent
* Ability to complete the Diabetes Prevention Program including dietary and physical activity recommendations
* Motivated to lose weight (assessed to be in the preparation or action stage)

Exclusion Criteria:

* Have used weight loss medications or participated in a weight loss program within the past 30 days.
* Are currently enrolled in DPP or other ExercisAbilities weight loss programs
* Are currently taking supplements known to affect weight.
* Have had weight fluctuations of 20 pounds or more in the past 6 months (EMR check and self-report)
* Have an active untreated clinically significant psychiatric condition (psychosis, bipolar disorder, or depression)
* Are currently pregnant or breastfeeding, or are of child-bearing potential and are likely to become pregnant during the study (within the next 4 months following enrollment)
* Have a history in the past 4 months of any major cardiovascular events including heart valve disease, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease
* Have current uncontrolled hypertension (systolic \> 160 mm Hg or diastolic \> 95 mm Hg) documented on 2 separate occasions
* Have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as diabetes) or active cancer or are within 1 year of cancer remission
* Have a known history of any condition or factor judged by the investigator/study team to preclude participation in the study or which might hinder adherence
* Have any co-morbidity that is deemed exclusionary at the discretion of the provider.
Safety, Tolerability, PK, and PD Study of PGN-EDODM1 in Participants with Myotonic Dystrophy Type 1

The primary purpose of the study is to evaluate the safety and tolerability of single intravenous (IV) doses of PGN-EDODM1 administered to participants with Myotonic Dystrophy Type 1 (DM1).

The study consists of 2 periods: A Screening Period (up to 30 days) and a Treatment and Observation Period (16 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of DM1, as defined as having a repeat sequence in the DMPK gene with at least 100 CTG repeats
* Medical Research Council (MRC) score of ≥ Grade 4 in bilateral tibialis anterior (TA) muscles (the ability to move through full range of motion and hold against at least moderate pressure from the examiner)
* Presence of myotonia

Exclusion Criteria:

* Congenital DM1
* Known history or presence of any clinically significant conditions that may interfere with study safety assessments
* Abnormal laboratory tests at screening
* Medications specific for the treatment of myotonia within 2 weeks prior to screening
* Percent predicted forced vital capacity (FVC) \<40%

Note: Other inclusion and exclusion criteria may apply.
A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis

The purpose of this study is to evaluate the efficacy and safety of IBI112 administered in different dose regimens for the treatment of patients with plaque psoriasis


Eligibility Criteria:
Inclusion criteria

* Diagnosis of plaque-type psoriasis with or without psoriatic arthritis for at least 6 months prior to first administration of any study agent
* Must be a candidate for phototherapy or systemic treatment for psoriasis (either new to treatment or having had previous treatment)

Exclusion criteria

* History of or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
* Participant has history of erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis
* Has received any therapeutic agent directly targeted to IL-12, IL-17, or IL-23within 6 months of the first administration of study agent
* Has received any therapeutic agent directly targeted toTNF-a within 3 months of the first administration of study agent
* Has received any conventional therapeutic agent within 1 months of the first administration of study agent
* Has received any topic therapeutic agent within 2 weeks of the first administration of study agent
The Role of the Pulmonary Vasculature in the Fontan Circulation

This study aims to explore the structural and functional characteristics of the pulmonary vasculature in adult Fontan patients.

Objectives:

* Determine the effect of pulmonary vasodilatation on indexed cardiac output during simulated exercise.
* Characterization of structural properties of small pulmonary arteries.

Rationale:

The Fontan circulation is a palliation for patients with a functionally univentricular heart. The Fontan circulation is characterized by impaired exercise capacity and gradual attrition over time. To date treatment options are extremely limited. It has been proposed that pulmonary vascular resistance (PVR) is the controlling and limiting factor of cardiac output in the Fontan circulation. Remodeling of the pulmonary vasculature and increasing PVR are possible key factors in the long term failure of the Fontan circulation. Optical Coherence Tomography (OCT) is an intravascular imaging modality used for structural characterization of blood vessels. Nitric oxide is a pulmonary vasodilator used in pulmonary vascular response tests, aimed at lowering PVR which may improve cardiac output in the Fontan circulation. These two diagnostic procedures are tools to study the structural and functional characteristics of the pulmonary vasculature in the Fontan circulation. The results of this study could identify the pulmonary circulation as a future treatment target in Fontan patients and may provide clues for new therapeutic treatment strategies to improve the long term outcome of these patients.

Study procedure:

The study protocol will be performed during a clinically indicated cardiac catheterization. In the context of this study additional measurements will be performed which will include a pulmonary vascular response test, trans-thoracic echocardiography and pulmonary artery OCT measurements.

Eligibility Criteria:
Inclusion criteria:

Fontan group

* written informed consent
* Clinical indication for cardiac catheterization

Control group

* written informed consent
* Clinical indication for right heart catheterization
* Absence of pulmonary vascular disease
* Normal pulmonary vascular hemodynamic profile

Exclusion criteria:

Fontan group

* Standard exclusion criteria for cardiac catheterization
* Obstruction in Fontan conduit
* Inability to measure a reliable cardiac index and PVR (rhythm instability, hemodynamic or anatomic reasons)

Control Group

- No specific exclusion criteria apart from the standard exclusion criteria for right heart catheterization.
Study of Amiloride on Vascular Phenotypes in Young Adults With Prehypertension

Primary Specific Aim: To test the hypothesis that amiloride will improve vascular health of young adults with prehypertension.


Eligibility Criteria:
Inclusion Criteria:

* Prehypertensive: Having systolic BP between 120 to 139 mmHg and/or diastolic BP between 80 to 89 mmHg during screening visit. BP will be measured manually tree times at 10 minutes interval after subjects sit quietly for at least 5 minutes in a chair. The average of last two BP measurements will be taken into consideration.
* Male or female of Caucasian or African-American origin.
* No history of any major past and current medical illness (such as diabetes, renal disease, liver disease etc.)
* Not taking any medication that affects blood pressure.

Exclusion Criteria:

* HbA1C \> 7.0 % during screening visit.
* Serum potassium \> 5.5 mEq/L during screening and/or any testing visit due to risk of developing hyperkalemia.
* Serum creatinine \> 1.5 mg/100 ml and/or creatinine clearance \< 50 ml/min\* (Glomerular Filtration Rate Estimate by Abbreviated MDRD Study Equation)35 during screening and/or any testing visit due to risk of developing renal dysfunction.
* Female having positive pregnancy test during screening and/or any testing visit.
Cognitive Remote Assessment Using FLAME (CRA-FLAME)

We aim to use a multimodal approach comprising conventional neuropsychological cognitive tests, fluid and imaging biomarker data, to explore their association with the FLAME unsupervised cognitive computerized assessment. We believe that this would provide critical information to move forward the current research framework in the field.

Participants will be selected from BBRC-sponsored studies, such as the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the Beta-AARC study (β-AARC_BBRC2020) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018)

We aim to use a multimodal approach comprising conventional neuropsychological cognitive tests, fluid and imaging biomarker data, to explore their association with the FLAME unsupervised cognitive computerized assessment. We believe that this would provide critical information to move forward the current research framework in the field.

Participants will be selected from BBRC-sponsored studies, such as the ALFA project (STUDY 45-65 FPM/2012), the ALFA+ cohort study (ALFA - FPM - 0311), the Beta-AARC study (β-AARC_BBRC2020) or the BarcelonaBeta Dementia Prevention Research Clinic study (BBRC-DemPrev-2018)

Eligibility Criteria:
Inclusion Criteria:

Participants must meet ALL the following criteria:

1. To sign the study informed consent form approved by the corresponding authorities.
2. Men and women that have participated/are participating in a BBRC-sponsored study.
3. To accept that:

   * The results obtained in this study may be published in scientific journals and at BBRC's communication channels (e.g. web page)
   * The data gathered may be used in combination with those gathered in other BBRC-sponsored studies in which they may (have) participate(d)

Exclusion Criteria:

1. Not having an ICT literacy enough to access and complete the online tests.