cyrilzakka/clinical-trials huggingface dataset:
Topical Treatment for Atopic Dermatitis

Medication adherence is a poorly studied phenomenon that challenges both patients and physicians. 50% of individuals with chronic disease are not adherent to their medication regimen. Within the United States, non-adherence to medical treatment leads to approximately $100 billion in hospital admission costs. While the issue of adherence is not limited to any particular field of medicine, non-adherence occurs in approximately one-third to one-half of dermatological patients. Non-adherence is of importance as it is a significant cause of treatment failure, resulting in worse quality of life, worse health outcomes, and increased insurance costs.

Unlike most modes of medication administration, topical medications do not have a standardized method of dosage administration\] Although qualitative administration measures exist, these measures are often arbitrary and not quantifiable (i.e., "a fingertip"). In such cases, inappropriate dosing (i.e., using too much or too little) is an essential cause of treatment failure, and measurements of adherence for topical medications should consider the amount of medication administered. In a study analyzing the response to treatment in psoriatic patients, patients who received a standardized dose of topical calcipotriol achieved a more significant decrease in mean Psoriasis Area and Severity Index (PASI) (47%) compared to patients who were not standardized (17%, P\<0.0001). Moreover, over two-thirds of psoriatic patients deemed initially poor responders in the standardized regimen group were considered responsive to treatment after further consideration.

Given topical options' low cost, efficacy, and excellent safety profiles, they are the first line treatment option for mild-to-moderate Atopic Dermatitis (AD) treatment. This study will aim to assess differences in the amount of medication dispensed in two groups of patients with atopic dermatitis. The first will undergo a brief educational demonstration by a trained professional to highlight the appropriate amount of topical medication to dispense for their disease involvement. The second group will be a control group and receive the same medication; however, the Participants will receive standard of care education (verbal and written instructions) only. Data from the two groups will be collected and analyzed to measure trends in dosing (i.e., if the correct dosage quantity and frequency was dispensed).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of skin dermatitis
* Age \> 9
* Ability to return for a one-week clinical studies follow-up
* Patients who are candidates for treatment with 0.1% triamcinolone ointment (even if they weren't in the study)
* Adult or pediatric patients with active dermatitis who receive dermatologic care at Atrium Health Wake Forest Baptist, Department of Dermatology.

Exclusion Criteria:

* Patients without the diagnosis of skin dermatitis
* Inability to return for a one week follow up appointment
* Body Surface Area (BSA) affected \<2%
A Clinical Trial Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris

The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

* Dermatological conditions of the face other than acne that could interfere with clinical evaluations
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of SHR-1918 in Patients With Homozygous Familial Hypercholesterolemia

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by SHR-1918 in patients with homozygous familial hypercholesterolemia (HoFH).


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of functional HoFH by either genetic or clinical criteria as defined in the protocol
2. LDL-C ≥2.6mmol/L at the screening visit
3. Body weight ≥40 kg
4. Receiving stable lipid-lowering therapy for at least 28 days before enrollment.

Exclusion Criteria:

1. Treatment with an ANGPTL3 inhibitor within 24 weeks prior before screening
2. Previously diagnosed type 1 diabetes or poorly controlled type 2 diabetes at screening (HbA1c \> 8.5%)
3. eGFR \<30ml/min/1.73m2 at the screening visit
4. CK \>5times ULN at the screening visit
A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

This is a multi-centre, single-arm treatment study combining lenalidomide plus high dose dexamethasone.

Subjects who qualify for participation will receive lenalidomide plus high dose dexamethasone in 4 week cycles. Subjects will be seen every 2 weeks for the first 3 cycles of therapy and then every 4 weeks after the third cycle until disease progression is documented, study drug is discontinued for any reason or lenalidomide becomes commercially available for this indication. Assessments of safety and quality of life are performed during the study.


Eligibility Criteria:
Inclusion Criteria:

* Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment.
* Subjects must discontinue all anti-myeloma drug or non-drug therapy prior to the first dose of study drug with the exception of radiation therapy initiated prior to baseline.
* Females of childbearing potential must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence.

Exclusion Criteria:

* Pregnant or lactating females
Data Collection Protocol for Patients With Von Hippel Lindau Disease

To collect information from patients with vHL disease. Information collected will include data on the status of the disease, any surgeries or therapies patients have received for vHL disease, and quality of life.

Primary Objectives:

* Obtain prospective and retrospective data on lesion development, surgical history and systemic therapy use in patients with vHL disease
* Assess genotype-phenotype correlation between VHL mutation type and patterns of lesion development
* Assess genotype-phenotype correlation for response to belzutifan in an organ-specific manner

Secondary Objectives:

--Obtain quality of life data in patients with vHL disease

Eligibility Criteria:
Inclusion Criteria:

* Presence of genetic confirmation or clinical criteria consistent with vHL disease.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients with psychiatric illness/social situations that would limit compliance with study requirements.
Bladder Lavage as Decontamination Method for Asymptomatic Bacteriuria With Uropathogens in Catheterized Patients

In patients with advanced multiple sclerosis, permanent urinary catheters are often used to manage the urinary incontinence and bladder emptying problems. These catheters will lead to urinary tract infection, blocking of the catheter etc.. Especially infections with certain bacteria such as proteus, enterobacteriaceae and ESBL producing enterobacteriaceae and pseudomonas can pose a problem for the hospital infection control and for the patient.

This study wants to evaluate the potential role of regular bladder lavage with saline, a solution of betadine, an acid solution of acetic acid and of URotainer Twin Suby G ( Braun)in the decontamination of these bladders and the prevention of clinically relevant urinary tract infections.

PAtients will be selected from the catheterised patient population of the National MS Center in Belgium for this prospective randomised comparative pilot studyon bladder lavage.

The potential benefit for the patient is a reduction in number of clinical urinary tract infections and a reduction of antibiotic use.

According to the type of bacteria that is cultured from the urine, patients will be allocated to one of 4 subgroups:

* 30 patients will recieve bladder lavage with a Isobetadine Dermicum Solution
* 20 patients will revieve bladder lavage with acetic acid solutions
* 10 patients will recieve bladder lavage with saline
* 10 patients will receive bladder lavage with Urotainer Suby G

The effect will be measured by two repeat urine cultures after the bladder lavage( 2days and 5 days).

From a safety perspective and to assess the irritation caused by the lavage, white blood cell counts in the urine will be done.

Adverse events will be monitored according to GCP regulations.

Eligibility Criteria:
Inclusion Criteria:

* patients with an indwelling catheter
* catheter associated bacteriuria with proteus, enterobacteriaceae or pseudomonas
* willing and able to give informed consent to the study

Exclusion Criteria:

* patients with a clinically relevant UTI ( fever, pain or cloudy urine)
* cognitively impaired patients
* patients not able or willing to give informed consent
* patients with allergies for ISobetadine dermicum or other substances used in the protocol
* patients who only have a catheter for less than 1 month
* patients taking systemic antibiotics during the last 48h
Impact of the Spatial Resolution of Several Contrast-enhanced 3D T1-WI Sequences When Diagnosing Giant Cell Arteritis (GCA)

Giant cell arteritis (GCA) (or Horton's disease) is a segmental and focal inflammatory arteritis affecting large and medium-sized arteries. Its incidence is estimated at 17.8/100,000 in subjects over 50 years old (and 46/100,000 in subjects over 70 years old). This disease remains a severe pathology due in particular to its vascular, ophthalmological, neurological, cardiac and aortic complications. In case of suspected CAG, management is a real therapeutic emergency. Indeed, only corticosteroid therapy started as early as possible can prevent the occurrence of these complications.

The gold standard for the diagnosis of CAG has long been the temporal artery biopsy, but imaging is now considered as a 1st line diagnostic examination for the diagnosis of CAG according to the EULAR 2018 recommendations. Notably, temporal artery MRI has excellent sensitivity and specificity for diagnosis.

However, the high diagnostic performance of MRI has been achieved by performing 3D T1 black blood and fat saturation sequences in high resolution (\<0.7mm), which are not accessible in all centers in France and worldwide.

The realization of identical sequences with a lower resolution could allow a greater generalization of these sequences and improve the diagnostic management of GCA patients, including in non-expert centers.

The objective of our study is to investigate the diagnostic performance of several 3D T1 black blood and fat saturation sequences for the diagnosis of GCA.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Referred for imaging for an injected MRI for suspected GCA
* Suspicion of GCA based on the presence of three major criteria or two major and one minor criteria defined as follows:

  * Major criteria: Age \> 50 years; Headache of recent onset; Claudication of the jaw, tongue or swallowing disorders; Visual problems (blindness, diplopia, blurred vision - including visual accidents occurring during the first week of treatment); Sedimentation rate at 1st hour \> 50 and/or CRP \> 8mg/l
  * Minor criteria: Hypersensitivity or induration of the scalp or presence of nodules remote from the temporal artery; Temporal artery abnormalities on palpation; Facial pain or feeling of facial edema; General signs (fever \>38°C, weight loss \>10%, anorexia, malaise, asthenia).
* Cconsent to participate in the study
* Affiliated or beneficiary of a social security plan

Exclusion Criteria:

* Newly diagnosed malignant disease (diagnosed less than one year prior to inclusion)
* Active infectious disease
* Autoimmune disease (especially but not limited to: Wegener's disease, Takayasu vasculitis, ANCA vasculitis, rheumatoid arthritis, lupus erythematosus, periarteritis nodosa).
* Systemic corticosteroid therapy for more than 10 days at high dose (\>0.5mg/kg/d of prednisone)
* Contraindication to MRI
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
Efficacy and Safety Study of Udenafil in Patient With Pulmonary Arterial Hypertension(PAH)

This is a placebo-controlled, double-blind, phase II clinical study to evaluate the efficacy and safety of Udenafil in patient with Pulmonary Arterial Hypertension(PAH).


Eligibility Criteria:
Inclusion Criteria:

• Subjects aged 18 and over who have any of the following diseases

* primary Pulmonary Arterial Hypertension
* secondary Pulmonary Arterial Hypertension caused by connective tissue disease
* \[Phase IIb\] Pulmonary Arterial Hypertension caused by congenital heart disease(including Eisenmenger syndrome)

Exclusion Criteria:

* Subjects with pulmonary arterial hypertension caused by any etiology other than those specified in the inclusion criteria
* BMI(Body Mass Index) \< 18.5kg/m2
* Subjects with hypotension(SBP/DBP\<90/50mmHg) or uncontrolled hypertension(SBP/DBP\>170/100mmHg)
* Creatinine clearance ≤ 30mL/min
* History of non-arteritic anterior ischemic optic neuropathy(NAION)
Local Anesthetic Concentration and Rebound Pain

The rebound pain after nerve block could interfere with patient's recovery and rehabilitation. It is not known how local anesthetic concentrations affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.

Shoulder surgery is related to more than moderate pain after surgery. Interscalene nerve block could reduce the postoperative pain effectively. When the effect of nerve block ends, however, rebound pain could appear. The rebound pain could interfere with patient's recovery and rehabilitation.

The mechanism of rebound pain is not well known. One of possible mechanism is that the pain stimulus that was blocked suddenly comes out, and it is perceived as more severe pain. The strength of the block may vary depending on the concentration of the local anesthetic. Therefore, the concentration of local anesthetics could affect rebound pain. The aim of this study is evaluation of the effect of local anesthetic concentration on rebound pain after interscalene block for shoulder surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective shoulder surgery under general anesthesia and interscalene block for postoperative pain

Exclusion Criteria:

* Contraindication of interscalene block: pulmonary disease, lung resection history, brachial nerve injury
* Diabetic neuropathy
* Adverse drug reaction history to ropivacaine, fentanyl
* Impaired coagulation
NF-1, Nutraceutical Intervention

The treatment plan is identical for all participants with the exception of the curcumin dose level that is assigned at study enrollment. Participants are instructed to take the curcumin and olive oil one after the other (order does not matter) twice a day on an empty stomach ideally 30 minutes before breakfast and dinner.

Curcumin and high phenolic extra virgin olive oil (HP-EVOO) may continue for up to 12 months in the absence of unacceptable side effects.


Eligibility Criteria:
Inclusion Criteria:

* NF1 diagnosis based on NIH Consensus Conference Criteria and/or genetic testing
* Measurable cutaneous neurofibromas (cNFs) with or without plexiform NF
* Aged 18 years or older at the time of written consent
* Voluntary signed written consent obtained before the performance of any study-related procedure not part of normal medical care

Exclusion Criteria:

* Concurrent treatment with selumetinib or other MAPK, MEK or mTOR inhibitors, other targeted therapies, chemotherapy or radiation
* Conditions requiring systemic immunosuppression
* Swallowing difficulties or strong gag reflex which may interfere with study compliance
* Any comorbidities that may affect study participation in the judgement of enrolling investigator
* Psychiatric illness, cognitive challenges, social situations, or other circumstances that would limit compliance with study requirements, per judgment of the enrolling investigator
* Treatment with high phenolic olive oil or curcumin within six months of study entry
* Known pregnancy or anticipated conception during the 1 year study period
Virtual Reality (VR) Diagnostic Tool for Attention Deficits/Hyperactivity Disorder (ADHD)

Attention deficit/ hyperactivity disorder (ADHD) is a common neurodevelopmental disorder. The common diagnostic of ADHD is based on psychiatric examination and interview. So far, there is not any other diagnostic tool for ADHD nowadays. Therefore, virtual reality (VR) technology can be used as a stimulus, replacing real stimuli, recreating experiences, which are in the real world would be impossible. Consequently, ADHD-VR diagnostic tool development should be started to justify the ADHD diagnosis in psychiatric out-patient clinical services.

Diagnostic test is a very essential in modern medical practices, especially in child and adolescent psychiatry field because the main diagnostic tool is only based on psychiatry interview and observation. Using Diagnostic tool can help a confirmation towards specific clinical diagnosis, provide more evidence for eliminating one diagnosis versus another, provide more evidence for parents, or to rule out the differential diagnosis. Even though psychiatric examination is the main approach on ADHD diagnostic procedure, however the laboratory testing or imaging examination is also used especially to rule out the general medical condition or to find out any medical conditions that mimic ADHD but not to facilitate the ADHD diagnosis per se. Nowadays, the expand study in biological psychiatry has found a lot of biological markers in ADHD as well; but none is really sensitive and specific for ADHD diagnostic test. Therefore, there should be another approach for developing diagnostic tool in ADHD. VR is one of the best approach bacasue these days, because VR as an ADHD diagnostic tool could create and replace real stimuli, recreating experiences, which could not be observed by the clinician at the out-patient clinic.

Eligibility Criteria:
Inclusion Criteria for ADHD group:

* Children with ADHD drug naive
* Parent willing to participate in the study by signing informed consent
* Children willing to participate the ADHD-VR diagnostic tool for at least 30 minutes

Exclusion Criteria:

* Having untreated chronic physical illnesses
* Having other mental disorders except ADHD

Inclusion Criteria for healthy children group:

* Do not have any mental disorder
* Do not have untreated chronic physical illnesses
* Parent willing to participate in the study by signing informed consent
* Children willing to participate the ADHD-VR diagnostic tool for at least 30 minutes
The Development of Upper Extremity Rehabilitation Program Using Virtual Reality for the Stroke Patients

Using the upper extremity rehabilitation program developed by virtual reality would help the recovery upper extremity function in patients with stroke.

This randomized, double-blind, controlled trial included 24 patients with ischemic stroke. The intervention group received 30 min of conventional occupational therapy (OT) and 30 min of the mobile upper extremity rehabilitation program using a smartphone and a tablet PC (MoU-Rehab). The controls (n = 12) received conventional OT alone for 1 h per day. Rehabilitation consisted of 10 sessions of therapy, 5 days per week, for 2 weeks. The outcome measures (Fugl-Meyer Assessment of the upper extremity \[FMA-UE\], Brunnstr¨om stage \[B-stage\] for the arm and the hand, manual muscle testing \[MMT\], modified Barthel index \[MBI\], EuroQol-5 Dimension \[EQ-5D\], and Beck Depression Inventory \[BDI\]) were assessed at the beginning and end of treatment, and at 1 month. User satisfaction was evaluated by a qestionnaire.

Eligibility Criteria:
Inclusion Criteria:

* ischemic or hemorrhagic stroke confirmed by brain imaging study
* upper extremity dysfunction
* possible to use a simple device

Exclusion Criteria:

* delirium, confusion or other evidence related to the consciousness
* uncontrolled medical or surgical disease
* unable to command to the order due to severe cognitive impairment
* visual impairment
* unable to sit
Biomarkers in Patients With Rhabdomyosarcoma

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in patients with rhabdomyosarcoma.

OBJECTIVES:

* Determine genome-wide alterations in DNA methylation in ARMS and ERMS.
* Determine genome-wide DNA copy number alterations in ARMS and ERMS.
* Determine pathogenic genes and pathways by integrative genomic analysis.

OUTLINE: Genome-wide DNA-methylation analysis on ARMS, ERMS, and normal human skeletal myoblasts will be conducted using the HELP (HpaII tiny fragment Enrichment by Ligation-mediated PCR) assay. The methylation status of 1.3 million CpGs at promoters, gene bodies, and intergenic areas will be analyzed. Parallel gene expression analysis will be done and correlated with changes in methylation to uncover genes regulated by epigenetic alterations and altered by genomic losses or gains.

Genes that are altered by both genetic and epigenetic alterations in different sets of patients will be selected by the MIGHT (Multi-dimensional Integration of Genomic data from Human Tissues) algorithm to uncover new genes that are potentially involved in the pathogenesis of ARMS and ERMS. Gene ontology, pathway, and DNA motif analysis algorithms, and other computational approaches will be used to determine the biological consequences of the changes. Prioritized set of epigenetic and genetic alterations will be validated by bisulfite MassArray, FISH, and qRT-PCR in larger numbers of ARMS and ERMS samples.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* 10 ARMS and 10 ERMS frozen samples will be collected from the COG bank via the Cooperative Human Tissue Network (CHTN)
* Human skeletal myoblasts (ZenBio, Research Triangle Park, NC) will serve as controls

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Efficacy and Safety of Astragalus for Non-motor Symptoms of α-Synucleinopathy

α-Synucleinopathy is a cluster of neurodegenerative disease with motor and non-motor symptom. However, there is still a lack of research on the treatment for non-motor symptoms of α-synucleinopathy, especially autonomic dysfunctions such as orthostatic hypotension. Efficacy and safety of astragalus for non-motor symptoms of α-synucleinopathy will be assessed by an open-label self-controlled before-and-after study.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a clinical diagnosis of PD, MSA and DLB, with orthostatic hypotension.
* Participants with cognitive disorder.
* Adults signed informed consents.

Exclusion Criteria:

* Patients with history of astragalus allergy.
* Patients with secondary Parkinsonism that cannot be excluded.
* Patients with diseases that may cause other types of hypotension or similar symptoms/signs because of hypotension
* Patients with other medical conditions requiring treatments that may affect blood pressure.
* Patients with other neurological disorders.
* Patients with serious comorbidities and immune diseases.
* Uncooperative patients.
* Pregnant or lactating women.