cyrilzakka/clinical-trials huggingface dataset:
Maximal Use Study of Tapinarof Cream, 1% in Adults With Extensive Plaque Psoriasis

This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in adults with plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects age 18 to 75 with a confirmed clinical diagnosis of plaque psoriasis and stable disease for at least 6 months prior to the study
* BSA involvement ≥ 20%
* PGA score of ≥ 3 at screening
* Females of child bearing potential and male subjects who are engaging in sexual activity that could lead to pregnancy agree to follow the specified contraceptive guidance throughout the study
* Capable of giving written informed consent

Exclusion Criteria:

* Psoriasis other than plaque variant
* Any sign of infection of any of the psoriatic lesions
* Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric, or cardiovascular (CV) system abnormalities or laboratory abnormality that will affect the health of the subject or interfere with the interpretation of the results
* Ultraviolet (UV) light therapy or prolonged exposure to natural or artificial sources of UV radiation within 4 weeks prior to the Baseline visit and/or plans to have such exposures during the study which could potentially impact the subject's psoriasis
* Use of any prohibited medication within the indicated period before the first dose of study drug
* Pregnant females or lactating females
* The subject has received an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the study drug (whichever is longer) prior to first dose of study drug
* Current or a history of cancer within 5 years except for fully excised skin basal cell carcinoma, squamous cell carcinoma or carcinoma in situ of the cervix
* Previous known participation in a clinical study with tapinarof
Biomarkers of Renal Dysfunction in Neuroblastoma Survivors

The main purpose of this study is to learn more about biomarkers of kidney function in the blood and urine of neuroblastoma survivors. A biomarker is a biological molecule found in blood, urine, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neuroblastoma between 0-18 years of age
* \< 21 years of age at time of study enrollment
* Two or more years from completion of systemic chemotherapy and/or radiation therapy

Exclusion Criteria:

* Patients treated with observation only
* Patients with multiple primary cancers
A Panel of Biomarkers in Diagnosing Late-onset Neonatal Sepsis and Necrotizing Enterocolitis in Sibu Hospital

This is a cross-sectional study to evaluate the utilities of a panel of biomarkers (Procalcitonin, Interleukin-6, Serum Amyloid A and Apolipoprotein C2) versus the gold standard blood culture result diagnosing late-onset neonatal sepsis (LONS) and/or necrotizing enterocolitis (NEC). Neonates who meet the initial screening criteria for suspected LONS or NEC will be recruited into the study. A group of 50 neonates who are clinically well, admitted to the nursery or general ward for reasons other than neonatal sepsis or NEC will also be recruited into the study.

The diagnosis of neonatal sepsis is challenging especially the very low birth weight infants as the signs and symptoms of sepsis are nonspecific and can be attributed to non-infected aetiologies including exacerbation of bronchopulmonary dysplasia, apnoea of prematurity and gastroesophageal reflux. Blood culture remains the gold standard for diagnosing septicaemia (either bacteremia or fungemia). However, its effectiveness in the population of preterm infants is compromised.Given the dire consequences of not treating the sepsis early, clinicians tend to have a low threshold for treatment. This leads to overuse of antimicrobials, promotion of antimicrobial resistance, exposure of infants to avoidable side effects from the antimicrobial treatment, prolonged hospitalisation and increased healthcare costs. Hence, there is a need for a clearly defined algorithm for diagnosing LONS and NEC. This study aims to examine the diagnostic utilities of a panel of sepsis biomarkers and explore if they can be incorporated into a diagnostic algorithm which hopefully, can be translated into clinical practice in the future.

Eligibility Criteria:
Neonates with suspected LONS/NEC

Inclusion Criteria:

* Infants with signs and symptoms suggestive of sepsis and/or NEC and requiring full sepsis screening and start of intravenous antibiotic(s), or a change of antibiotics (if already on)
* Infants with postnatal age greater than 72 hours and less than 28 days of life, of all gestation
* Parents of potential neonates who are willing to give written informed consent

Healthy subjects

Inclusion Criteria:

* Clinically well infants admitted to Sibu Hospital for reasons other than neonatal sepsis or NEC
* Infants with postnatal age greater than 72 hours and less than 28 days of life, of all gestation

Exclusion Criteria:

* Infants who have lethal or life-threatening congenital abnormalities
* Infants who have chromosomal abnormalities
* Infants who have hypoxic ischemic encephalopathy
* Infants who are on steroid treatment
* Infants who received blood transfusions
* Post-operative infants
Study of Lactulose in Children With Chronic Liver Disease

Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.

In addition ,serum ammonia levels will be obtained at beginning of study,post-washout and at end of study to evaluate Lactulose effect on serum ammonia.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy

Exclusion Criteria:

* patients with neurological,psychiatric or unstable medical conditions which may contribute to impaired cognitive function.
* patients with known hearing or vision difficulties.
* those patients who do not speak English will be excluded.
Blinding Assessment of Manual Therapy Interventions of the Back in Swiss Graduate Students

There is marked uncertainty regarding the feasibility of achieving adequate blinding in randomized controlled trials of manual therapy. In other words, whether participants and outcome assessors can accurately perceive randomly assigned interventions is unclear. This feasibility trial was conducted as part of a doctoral epidemiology course at the University of Zurich, Switzerland. Within the practice-based context of the class and using a study population of healthy graduate students enrolled in the course, the investigators aimed to evaluate blinding of participants randomly assigned (similar to tossing a coin) to one of two manual therapy interventions (active versus control). The investigators also aimed to assess blinding among outcome assessors.

Manual therapy remains a guideline-compliant, first-line therapeutic option for back pain. Yet, maintaining methodological quality in randomized controlled trials of manual therapy interventions poses challenges, particularly concerning: (a) The design of adequate 'sham' controls and (b) the blinding status of participants and outcome assessors. Optimal implementation of large-scale manual therapy trials requires testing the feasibility of control manual therapy interventions and effective blinding of participants and outcome assessors. Even when conducted in healthy populations and non-clinical settings, blinding feasibility trials remain an opportunity for methodological advancement in the field of manual medicine, and a research priority for unbiased treatment effect estimation in future trials.

The primary objective of this methodological trial was to quantitatively assess blinding feasibility among participants (graduate students enrolled in an epidemiology Ph.D. course) assigned to an active or control intervention immediately after a one-time intervention session. The secondary objective was to assess blinding feasibility among outcome assessors and explore factors influencing perceptions about intervention assignment among participants and outcome assessors. These two objectives contributed to obtaining valuable preliminary measures of blinding (blinding indices) for a future methodological blinding feasibility trial to be carried out in a real-world clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* enrolled in a doctoral-level epidemiology course at the University of Zurich, Switzerland.

Exclusion Criteria:

* serious pathology (i.e., cancer, severe scoliosis, inflammatory disease, infection, cauda equina syndrome or progressive motor deficit)
* history of spine surgery
* obvious contraindication to manual therapy (i.e., spinal fracture)
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

This study will evaluate the efficacy and safety of ALKS 5461.


Eligibility Criteria:
Inclusion Criteria:

* Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
* Agree to use an acceptable method of contraception for the duration of the study
* Have a Major Depressive Disorder (MDD) primary diagnosis
* Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
* Additional criteria may apply

Exclusion Criteria:

* Have a current primary Axis-I disorder other than MDD
* Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
* Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime
* Have attempted suicide within the past 2 years
* Have a positive test for drugs of abuse
* Are pregnant, planning to become pregnant, or breastfeeding
* Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Have had a significant blood loss or blood donation within 60 days
* Additional criteria may apply
Advancing Nutritional Science for Children With Functional Dyspepsia

This study evaluates four different meals and how they induce gastrointestinal symptoms in children with functional dyspepsia. All subjects will receive each meal and rate their gastrointestinal symptoms during each meal.

Food can often exacerbate gastrointestinal symptoms in adults and children with functional dyspepsia. However, it is unclear which foods exacerbate symptoms more than others.

Children with post-prandial distress functional dyspepsia will receive four different meals with variables being: semi-solid vs. solid and high fat vs high carbohydrate. At the time of ingestion and for up to 3 hours after each meal, subjects will rate their gastrointestinal symptoms. Comparisons of symptom onset and severity will be made for each meal.

Enrolled subjects will have undergone previous gastrointestinal evaluations: gastric emptying study and/or upper endoscopy. In addition, subjects will complete psychosocial measures: Behavioral Assessment for Children-3, childhood somatization inventory.

The first goal is to compare the severity of gastrointestinal symptoms with different composition and consistency meals. The second goal is to correlate the severity of postprandial gastrointestinal symptoms to psychosocial distress, gastric neuromotor function (emptying and accommodation), and duodenal inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Rome IV Functional Dyspepsia with post-prandial distress
* Previously completed normal upper endoscopy with duodenal biopsies and/or previously completed a gastric emptying scintigraphy study

Exclusion Criteria:

* Previous abdominal surgery
* Current or previous formal psychiatric diagnosis (e.g. anxiety disorder) requiring therapy or psychotropics
* Serious chronic medical condition requiring regular medical care
* Allergy to meal components to be ingested during the study
* On specialized diet required for a medical condition
* Pregnancy
* Inability to eat by mouth
Controlled Study of ONO-5046Na in Patients With Acute Respiratory Failure Associated With Community-Acquired Pneumonia

The purpose of this study is to determine the safety and efficacy of ONO-5046Na in patients with acute respiratory failure associated with community-acquired pneumonia


Eligibility Criteria:
Inclusion Criteria:

* Patients with community-acquired pneumonia
* Patients with acute respiratory failure

Exclusion Criteria:

* Patients with nosocomial pneumonia
* Patients on mechanical ventilation
Effects of Repetitive Transcranial Magnetic Stimulation Combined With Sensory Cueing on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke

The objective was to compare the effects of repetitive Transcranial Magnetic Stimulation (rTMS) combined with sensory cueing (SC), rTMS alone, and conventional rehabilitation on reducing unilateral neglect (UN) and improving hemiplegic arm functions and performance of activities of daily living (ADL). Sixty subacute patients with left UN after right-hemispheric stroke were randomly assigned to three groups; rTMS combined with SC, rTMS alone, and conventional rehabilitation. rTMS at 1 Hz was applied over P5 of the contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the hemiplegic arm, five days per week for two weeks. The first two groups received the same dosage of conventional rehabilitation on top of their experimental interventions. Blinded assessments were administered at baseline, 2 weeks postintervention, and four-week follow-up upon completion of training.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of right-hemispheric stroke
* Duration since onset of more than one week
* Presenting with unilateral neglect, confirmed by the conventional subtests of the BIT with cutoff scores of 129
* First-ever stroke, or unilateral neglect as the consequence of the last stroke
* Being aged 18 or over
* Mini Mental State Examination score of ≥17
* Giving written consent to participate.

Exclusion Criteria:

* Duration since onset of stroke of more than six months
* Medically unstable
* Epileptic seizures, unconsciousness, or intracranial hypertension
* Serious heart disease
* Gravid
* Severe aphasia so as to have difficulty understanding the therapists' instructions
* Metal implants in vivo
Chemotherapy Followed by Radiation Therapy in Treating Patients With Malignant Glioma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of cladribine followed by radiation therapy in treating patients who have malignant glioma.

OBJECTIVES: I. Determine the maximum tolerated dose of cladribine in combination with radiotherapy in patients with high grade glioma. II. Assess this regimen in terms of toxicity and survival in these patients. III. Assess the acute neurotoxicity of continuous infusion cladribine in these patients. IV. Assess this regimen in terms of response, local control, and time to progression in these patients. V. Define a dose level of cladribine associated with potentiation of acute and/or delayed radiation toxicity (radiosensitizing dose level).

OUTLINE: This is a dose escalation study of cladribine. Patients receive cladribine by continuous IV infusion 5 days a week for 4 weeks and undergo radiotherapy twice a day, beginning 3 hours after initiation of cladribine, 5 days a week for 4.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of cladribine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed at 1 month, then every 3 months thereafter for survival.

PROJECTED ACCRUAL: A total of 12-42 patients will be accrued for this study within 18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven high-grade glioma confined to 1 or both hemispheres of the brain and including: Grade III astrocytoma (anaplastic astrocytoma) Grade IV astrocytoma (glioblastoma multiforme) ineligible for NCI-95-C-0069 protocol Histologic confirmation of high-grade astrocytoma by NIH neuropathology division required (including mandatory review of slides from biopsy or resection) No evidence of metastatic or leptomeningeal spread

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% ECOG 0-2 Life expectancy: Greater than 6 months Hematopoietic: WBC at least 3,500/mm3 Absolute granulocyte count at least 900/mm3 Absolute leukocyte count at least 900/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Liver function tests no greater than 2.5 times upper limit of normal Renal: Creatinine clearance at least 95 mL/min Creatinine no greater than 1.3 mg/dL Other: No history of psychiatric disease that would prevent compliance No other malignancy within the past 5 years except: Basal cell carcinoma of the skin Carcinoma in situ of the cervix Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No systemic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior cranial radiotherapy Surgery: No more than 3 months since surgery (biopsy; subtotal or near-total resection)
12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients

This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on Poser or McDonald criteria (may include patients with secondary progressive disease)
* Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months
* Baseline EDSS score of 0 - 6.5
* Female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception

Exclusion Criteria:

* Primary progressive MS
* Any medical condition that predisposes to immunocompromise
* History of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection
* Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus)
* Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation
* Treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation
* Treatment with interferon beta or glatiramer acetate within 2 months of study initiation
* Prior treatment with natalizumab or rituximab
Oral Imaging for Porphyrin Biomarkers

The purpose of this study was to use the principle of fluorescence to identify oral diseases not readily visible to the naked eye. A imaging device with a removable and modular head consisting of arrays of Light Emitting Diodes (LEDs) with differing wavelengths (405nm,450nm or white) was used to image teeth to detect fluorescent biomarkers such as porphyrins associated with poor oral health (plaque). The process utilizes illumination of the teeth and gums using a specific array of LEDs in the visible and near-visible spectrum and is non-invasive. Successful implementation of the device would provide proof-of- concept validation for its use as a safe, rapidly deployable solution to assess oral hygiene.

To use the device, an interchangeable head with a specific LED wavelength was selected (to target a specific oral disease). The optical filter can be exchanged for another if necessary (this is done prior to the subject visit as to not prolong the time of the visit). During operation, LED intensity can be altered using the rotary dimmer switch. The procedure took place during a routine dental visit once consent was obtained. The device was covered in a clear disposable plastic sheath (Consolidated Plastics, Stow, OH) or equivalent sterile disposable camera bag. After both the subject and clinician wore UV protective eyeware, a series of images and videos were taken. These included detailed frames of all 4 incisors and all 4 canines. A video of the camera aperture passing over the select teeth was also taken. Additional images focusing on areas of interest to the clinician were taken, with area of capture and device mode recorded. The total time required to capture all images and video is expected to be approximately 5 minutes. As a control, an Acteon Soprocare a commercial device operating under the same fluorescence principle was also used. Images and video of the aforementioned eight target teeth in each mode were similarly captured for comparison to the test device.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-70. Subjects with identifiable dental diseases must have otherwise healthy tissues/structures in which to control against.

Exclusion Criteria:

Subjects under 18 years of age will not be invited to participate
Asthma Exacerbation Study

This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of asthma
* Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
* FEV1 of fifty to ninety percent of predicted
* Currently using inhaled corticosteroid therapy
* History of one or more asthma exacerbations requiring treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization in previous year

Exclusion Criteria:

* History of life threatening asthma in previous 5 years (requiring intubation, and/or associated with hypercapnia, hypoxic seizure or respiratory arrest
* Respiratory infection or oral candidiasis
* - Uncontrolled disease or clinical abnormality
* Allergies
* Taking another investigational medication or prohibited medication