cyrilzakka/clinical-trials huggingface dataset:
A Trial to Assess the Effect of Delgocitinib Cream 20 mg/g on the Molecular Signature, Safety, and Efficacy in Adults With Frontal Fibrosing Alopecia

This purpose of this trial was to investigate the molecular signature of frontal fibrosing alopecia (FFA) and the effect of delgocitinib cream 2% on reversing the FFA disease signature in active lesions. The trial also investigated the clinical effect of delgocitinib cream on FFA compared to a placebo cream.


Eligibility Criteria:
Inclusion criteria

For Group 1 only (subjects with FFA):

1. Male or female subject aged 18 years of age or older at the time of consent.
2. Subject has clinically confirmed diagnosis of FFA.
3. Subject has a target area with a perifollicular erythema score ≥ 2 and a perifollicular scale score ≥ 2 at Screening and Day 1.

For Group 2 only (healthy subjects):

1. Female subject aged 45 years of age or older at the time of consent.
2. Female is postmenopausal.
3. Subject is in good general health.

Exclusion criteria

For all subjects:

1. Subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the trial.
2. Presence of hepatitis B or C infection or HIV infection at screening.

For Group 1 only (subjects with FFA):

1. History of other scalp/hair disease including discoid lupus erythematosus and central centrifugal cicatricial alopecia.
2. Subject who has undergone scalp reduction surgery or hair transplantation.
3. Subject is known to have immune deficiency or is immunocompromised.
4. Subject has used intralesional scalp corticosteroids or platelet rich plasma injection in the last 4 weeks prior to randomization.
5. Subject has used systemic treatment with immunosuppressive/modulating medication or medication within 4 weeks prior to randomization.
6. Subject has used any topical medicated treatment that could affect FFA within 2 weeks prior to randomization.
7. Subject has received any phototherapy within 4 weeks prior to randomization.

For Group 2 only (healthy subjects):

1. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the trial assessments.
2. Subject has used a topical medicated treatment on the targeted skin sites within 2 weeks prior to trial assessments.
Emergent Prep for IV Dye in Acute Stroke Patients With Allergy

Our institution implemented a protocol to administer an emergent IV dye preparation for stroke alert patients requiring advanced neuroimaging. The emergent IV dye preparation consists of diphenhydramine 50 mg IV once, famotidine 20 mg IV once, and dexamethasone 10 mg IV once, followed immediately by Computed Tomography (CT) Angiography and/or CT Perfusion.

Patients with documented IV dye allergy were given emergent dye preparation immediately prior to advanced neuroimaging that consisted of three drugs: diphenydramine 50 mg IV, famotidine 20 mg IV, and dexamethasone 10 mg IV. In contrast, elective dye preparation commonly done in non-emergent or outpatient settings is separated into two different options. The first option is for a patient to take Prednisone 50 mg three times prior to the study: one tablet by mouth 13 hours prior, one tablet by mouth seven hours prior, and the last tablet by mouth one hour prior to the study. The second option is for the patient to be prescribed dexamethasone 4 mg or 6 mg dispensed four times: two tablets by mouth 12 hours prior to the study and 2 tablets by mouth one hour prior to the study. If the patient is prescribed dexamethasone, they also take famotidine 150 mg and diphenhydramine 50 mg, both drugs by mouth 12 hours prior and one hour prior to the study.

To evaluate the relationship between dye allergy and any adverse reactions, our study's inclusion criteria consisted of all stroke alert patients from 2021-2022 who required advanced neuroimaging of CTP/CTA and received emergent IV dye preparation. Exclusion criteria included patients who reported dye allergies specific to airway edema or anaphylaxis. A retrospective chart review was done to evaluate stroke patient's stated allergies, the number of patients that received emergent IV dye preparation, and any adverse reactions despite the emergent IV dye preparation. Data was then analyzed to determine if there was a relationship between prior contrast dye allergy and allergic reactions that occurred after emergent IV dye administration.

Eligibility Criteria:
Inclusion Criteria: Stroke alert patients that required advanced neuroimaging of CTP/CTA and received emergent IV dye preparation -

Exclusion Criteria: patients who reported dye allergies specific to airway edema or anaphylaxis

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Lumbar Disc Herniation Outcome Measures

This study is being conducted to examine outcome measurements on patients who undergo surgery to removed a damage lumbar spine disc versus those that chose not to have surgery. These outcomes are based on patient responses to quality of life and pain questionnaires.

Lumbar discectomy is the most common surgical procedure performed for back and leg symptoms in US patients, but the efficacy of the procedure relative to non-operative care remains controversial.

Several studies have compared surgical and non-operative treatment of patients with herniated discs, but baseline differences between treatment groups, small sample sizes, or lack of validated outcome measures in these studies limit evident-based conclusions regarding optimal treatment.

There is increasing emphasis on the use of health-related quality of life(QOL)outcome measures to determine the efficacy of treatment, particularly for diseases that are not life threatening but affect the patient's QOL. In the treatment of lumbar disc herniation, the Medical Outcomes Study Short Form (SF-36), Oswestry Disability Index (ODI) and Visual Analog Scale (VAS), are validated and common scales that are used to measure treatment outcomes.

Information is routinely collected on activity limitations in the course of the doctor's assessment of the patient, however, the data may not always be collected in a standardized format that yields measurement with known reliability and validity. Standardized self-report questionnaires provide a convenient method of collecting and synthesizing a large amount of information on the pain, activity limitation and general health status of each patient.

The objective of this prospective study is to evaluate the efficacy of surgery for lumbar intervertebral disc herniations using the SF-36, ODI and VAS as primary outcome measures. Patients experiencing acute or chronic lumbar spine pain in the Orthopedic practice will be given a choice to participate in this study. On patient's who wish to participate, the data will be collected and entered into the REMARK OMR 7 database, and evaluated for outcomes.

This study is for current patients in the Upstate Orthopedic office.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age and no older than 90 years of age
* Must have diagnosis of Lumbar disc herniation
* Must be able to understand English, and willing to consent to data collection
* Must be a current patient in our practice

Exclusion Criteria:

* Prisoner
* Unable to complete questionnaires
Clinical Impact of Automated Oxygen Administration on Confirmed or Suspected COVID-19 in the Emergency Department.

The aim of this study is to evaluate the impact of the FreeO2 system on the quality of the oxygen therapy in confirmed or suspected SARS-CoV-2 patients in the emergency department.

The aim of this study is to evaluate the impact of the FreeO2 system on the quality of the oxygen therapy in confirmed or suspected SARS-CoV-2 patients in the emergency department. The quality of oxygen therapy is evaluated by the time spent in the SpO2 target (+/- 2% SpO2 target), time spent in hyperoxemia (\> 5% SpO2 target), time spent in hyperoxemia (\<5% SpO2 target).

Eligibility Criteria:
Inclusion Criteria:

* Hypoxemic patients on automated oxygen therapy during their emergency department stay
* Confirmed or suspected SARS-CoV-2 patients in the emergency department

Exclusion Criteria:

* Patient on automated oxygen therapy in the emergency department without accessible data of the FreeO2 device.
Drug-Drug Interaction of ASN51 With Fluvoxamine, Itraconazole and Paroxetine in Healthy Subjects

The drug-drug interaction study has been designed to investigate the effect of Fluvoxamine, Itraconazole and Paroxetine on the pharmacokinetics of ASN51


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy males or females of nonchildbearing potential
* Aged 18-55 years (inclusive) at time of Screening
* Deemed healthy based on medical history, physical and neurological examination, electrocardiogram (ECG), vital signs, and laboratory tests of blood and urine
* Body weight ≥ 50.0 kg (men) or ≥ 45.0 kg (women) at Screening
* Body mass index (BMI); Quetelet index in the range 18.0-30.9 kg/m2 (inclusive) at Screening

Key Exclusion Criteria:

* Clinically relevant abnormal medical history, physical or neurological findings, ECG, or laboratory values at Screening, or before the first dose of any study medication, that could interfere with the objectives of the study or the safety of the subject
* History or presence of acute or chronic illness, or clinically-significant medical abnormality, sufficient to invalidate the subject's participation in the study or make it unnecessarily hazardous
* History or presence of any disease, medical condition, or surgery (e.g., stomach bypass), likely to affect the absorption, distribution, metabolism, or excretion of medicines. Subjects with a history of cholecystectomy
* Presence or history of severe or clinically significant adverse reaction to any drug; or a history of sensitivity to ASN51 (all subjects), or any components of the medications
* Receipt of an investigational product or device within 6 weeks (or 5 half-lives, or twice the duration of the biological effect, of the investigational product, if known - whichever is longer) before the first dose of study medication; in the follow-up period of another clinical study at the time of Screening for this study
* Use of a prescription medicine during the 14 days (or 5 half-lives of the medicine, if known - whichever is longer) before the first dose of study medication
* Use of an over-the-counter medicine, including vitamins, herbal, or dietary supplements (including St John's Wort), with the exception of acetaminophen (paracetamol), during the 7 days (or 5 half-lives of the medicine, if known - whichever is longer, or 28 days if the medicine is a potential hepatic enzyme inducer) before the first dose of study medication
* Positive test for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Circadian Rhythm Impact on TNBC Response to Neoadjuvant Immunotherapy

CIRCADIAN is a prospective randomized clinical trial designed to evaluate the impact of pembrolizumab infusions' time-of-day on pathological complete response (pCR) rate among TNBC patients undergoing neoadjuvant treatment.

Patients will be randomized 1:1 to receive all neoadjuvant pembrolizumab cycles (400 mg every 6 weeks) before versus after noon. Subjects will be stratified based on clinical stage at diagnosis (St. II vs III).

Primary outcome will be pCR rate. As a secondary outcome, we will assess for treatment related toxicity.

For planned exploratory circadian rhythm evaluation, daily body temperature and salivary cortisol variation will be measured before each ICI infusion and the Munich Chronotype Questionnaire (MCTQ) will be applied. To assess for emotional stress, physical exercise habits, stimulating substances use and light exposure, patients will also be subjected to the Distress Thermometer and a lifestyle questionnaire. For planned exploratory biomarker research, tumor infiltrating lymphocytes (TILs) analysis will be performed on the initial diagnostic biopsy and after surgery, on residual tumor (in patients not achieving pCR). Cytokine quantification and bulk RNA sequencing plus flow cytometry studies for immune populations profiling will be performed on peripheral blood, at baseline and before surgery, to check for potential biomarkers of circadian modulation.

Eligibility Criteria:
Inclusion Criteria:

* Female sex
* Age 18 - 75 years old
* Diagnosed with Stage II or III TNBC and candidates for neoadjuvant treatment with ChT+pembrolizumab after multidisciplinary group discussion.

Exclusion Criteria:

* Patients unable to understand or consent to the study;
* Patients not completing ≥2 cycles of planned neoadjuvant pembrolizumab cycles or ≥50% of planned neoadjuvant ChT cycles;
* Patients under daily ≥10 mg of prednisolone or equivalent
Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with auto-immune hepatitis based on liver biopsy results, with the indications of immunosuppressive therapy;
* High levels of total bilirubin (TB) (≥10 X ULN);
* High levels of immunoglobulin G(IgG) (≥1.5 X ULN);
* Agreed to participate in the trial, and assigned informed consent;

Exclusion Criteria:

* The presence of hepatitis A, B, C, D, or E virus infection;

  * Patients with presence of liver cirrhosis or portal hypertension;
  * Primary sclerosing cholangitis, non-alcoholic steatohepatitis, drug induced liver disease or Wilson disease confirmed by liver biopsy;
  * Pregnant and breeding women;
  * Patients with severe anemia (hemoglobin \< 8 g/dL), leukopenia (WBC \< 2500/mm3), or thrombocytopenia (platelet count \< 50,000/mm3);
  * Severe disorders of other vital organs, such as severe heart failure, cancer;
  * Parenteral administration of blood or blood products within 6 months before screening;
  * Recent treatment with drugs having known liver toxicity;
  * Taken part in other clinic trials within 6 months before screening.
Vitamin/Mineral Absorption From Two Different Supplements

The objective of this project is to evaluate the postprandial serum and plasma vitamin and mineral levels in healthy adult men and women between 18 and 32 years of age, following a single intake of a multivitamin and mineral supplement processed in two different ways.

Serum or plasma levels of five vitamins and four minerals will be measured at baseline, and 1, 2, 4, and 6 hours after the intake of a multivitamin/mineral supplement processed by two different methods. The two methods involve using either conventional isolated vitamins and minerals blended together to provide approximately 100% of the Daily Value, or using the same amount of vitamins and minerals that have first been processing into liposomal forms before blending.

Participants are required to come for two study visits which are 5 to 7 days apart. Health screening will also be done at Study Visit 1. The order of supplement assignment will be randomized, performed in a double-blind manner.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females 18-32 years of age
* BMI 18.5-32 kg/m2
* Free from disease
* Normal blood levels in the comprehensive metabolic panel, or values slightly out of range as approved by the study physician
* Normal blood pressure (individuals whose average blood pressure is greater than 140/90 will be excluded from the study)
* Suitable vein structure and access for successful placement of an indwelling catheter, as determined by our nurse phlebotomist

Exclusion Criteria:

* Alcohol consumption \> 3 drinks/week (i.e., 1 bottle of beer, 1 glass of wine, and 1 shot of hard liquor)
* Smoking
* Vaping or using cannabis in any form
* Using multivitamin/mineral supplements in the past two months
* Currently taking supplements including botanical supplements, probiotics or fiber
* Fruit consumption ≥ 2 cups/day
* Vegetable consumption ≥ 3 cups/day
* Coffee/tea ≥ 3 cups/day
* Chronic/routine high-intensity exercise
* Any chronic health conditions
* Self-reported malabsorption
* Currently taking prescription drugs
* Indications of substance or alcohol abuse within the last 3 years
* Unable to consent
Ceramic Versus Composite in the Treatment of Posterior Teeth by Inlays or Onlays

The main purpose of this trial is to determine which material, between ceramic and composite, is best to manufacture dental inlays and onlays in the treatment of moderate dental substance losses, generally due to dental caries. Restorations will be done using direct Computer Assisted Design and Manufacturing (CAD-CAM). Another aim of this study is to determine which factors influence the success of these restorations.

WHO estimates dental caries prevalence to be over 90% adults worldwide. When tooth substance loss due to the decayed tissue is small, a filling is done by the dentist directly. When the substance loss is important, dentists often treat it with a crown, which presents the disadvantage of further mutilating the tooth. An intermediate technique consists in manufacturing an inlay or an onlay: these restorations become more and more common since they are a minimally invasive solution in such cases. Inlays and onlays can be made of metal, ceramic or composite. Patients tend to refuse metallic restorations, so that dentists generally have to choose between composite and ceramic. Composite wears whereas ceramics fracture. Published in vitro studies provide possible answers to which material is most effective but very few clinical studies have been conducted to confirm them. Material\\'s choice for inlay manufacturing is thus more country-based than evidence-based (Most french dentists choose composite while US dentists prefer ceramics for example). The main objective of this trial is to compare the clinical performance of ceramic and composite inlays/onlays. Other objectives include looking for the prognostic factors of these restorations and validating the criteria proposed by the World Dental Federation (FDI) to evaluate dental restorations.

Eligibility Criteria:
Inclusion criteria :

* patient aged 18-70,who tolerates restorative procedures and presents a moderate-sized dental caries or restoration (that needs to be replaced) necessitating an inlay/onlay restoration.

Exclusion criteria :

* allergy to one of the materials employed, bruxism, severe or acute periodontal or carious disease, poor oral hygiene
* Tooth presents a mobility \> II, a periodontal socket \> 3mm or supports a removable partial denture

Randomization criterium :

* tooth necessitates an inlay-onlay restoration after caries or former restoration removal

Exclusion from randomization criteria :

* subgingival margin after cavity preparation, rubber dam cannot be placed, all tooth cuspids need to be covered by the restoration.
Overnight Pant Study for Children With Nocturnal Enuresis

This study will evaluate the in-use tolerance of an absorbent disposable underwear pant developed for children with nocturnal enuresis by assessing adverse events. In addition product performance will be assessed by the parent at home via a daily diary.


Eligibility Criteria:
Inclusion Criteria:

Participants are eligible for enrollment if the parent/legal guardian responds positively ("Yes") to the following questions:

1. Have you read, understood and signed the Informed Consent document?
2. Is your child generally healthy?
3. Is your child 4-7 years of age?
4. Does your child weigh approximately 37-63 pounds and fit into the test pant?
5. Thinking of the past 3 months, does your child wet the bed at night at least once per week?
6. Is your child currently using overnight pants or diapers?
7. Is your child willing to use their usual and/or supplied overnight pant products every night for the duration of the study?
8. Are you and your child willing to refrain from using wet wipes in the pant area for the duration of the clinical trial?
9. Are you willing to refrain from enrolling your child in other clinical or consumer studies for the duration of this clinical trial?
10. Are you and your child willing to refrain from using lotions, creams, ointments, oils, moisturizing bubble baths, powders, sunscreen and/or skin preparations in the child's pant area and on thighs for the duration of this clinical trial, unless required for medical reasons?
11. Are you and your child willing and able to comply with all study instructions?
12. Are you able to fill in the required questionnaires in English?

Exclusion Criteria:

Participants are ineligible for enrollment if the parent/legal guardian responds positively ("Yes") to any of the following questions:

1. Does your child have any acute or chronic skin conditions (excluding skin rash) in or around the pant area?
2. Does your child currently have (or have a history of) any significant illness or chronic medical condition?
3. Is your child currently using any medications?
4. Does your child currently wear absorbent products during the day?
5. Does your child suffer from any other lower urinary tract symptoms (e.g., increased frequency, daytime incontinence, urgency, genital, or lower urinary tract pain) or a history of bladder dysfunction?
Detection of Colorectal Adenoma by Optical Enhancement Technology vs. High-Definition Colonoscopy

Optical Enhancement Technology might be superior to the conventional HD-WL in detecting colorectal adenomas

Colorectal cancer is the third most common cancer in the world.Colonoscopy is the gold standard screening test for colorectal cancer.There are also emerging data to support that screening by colonoscopy reduces both the incidence and mortality of colorectal cancer.However,Colonoscopy could still miss colorectal adenomas and even cancer.The miss rate for colonic adenomas was reported to be ranging from 15 to 32% in tandem colonoscopy studies.The reasons for the miss rate may be technical(insufficient during excessively fast instrument withdrawal),but may also be the imaging method.Smaller lesions ,particularly flat ones ,may be missed as a result of their subtle appearance and limited contrast in relation to the surrounding mucosa.

Some image-enhanced modules were developed with an aim to improve colorectal polyp or adenoma detection.The widely available modules is the narrow band imaging(NBI).However,most studies failed to demonstrate any superiority of NBI system over white light colonoscopy in detecting colonic polyps.NBI provides dimmer images of the colonic mucosa ,which may limit its performance on polyp and adenoma detection.

Like NBI,OE technology is image-enhanced module,providing a more intense look at the vascular pattern morphology.Besides,OE technology provides an much brighter image compared to NBI.This may possibly increase polyp detection by enhancing visibility of the colonic mucosa with brighter image.The current study aims to tested whether OE technology would improve adenoma detection when compared with high-definition colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients were selected if they presented for diagnostic colonoscopy for a variety of indications(eg positive fecal occult blood test, abdominal pain, diarrhoea,post-polypectomy surveillance).

Exclusion Criteria:

* Patients with prior resection of the proximal colon, advanced colonic cancer, inflammatory bowel disease, or polyposis syndrome.
* The cecum could not be intubated.
* Inadequate bowel preparation (Aronchick Bowel Preparation Scale score poor or inadequate).
* Biopsies were not available.
* Unable to provide informed consent.