cyrilzakka/clinical-trials huggingface dataset:
Investigating Age Dependence of Fibroblast and Extracellular Matrix Responses to Cross-linked Hyaluronic Acid Filler in Human Skin

The purpose of the study is to investigate the impact of the injection of dermal filler on the quality of the skin dermal extracellular matrix in persons between the ages of 30-50 years. The quality of the dermal extracellular matrix will be assessed following injection of dermal filler compared to injection of saline vehicle.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must understand and sign the informed consent prior to participation
* Subjects must be in generally good health
* Subjects must be able and willing to comply with the requirements of the protocol

Exclusion Criteria:

* Pregnant, plan to become pregnant during the study, or are nursing a child. Participants will be asked to self-report pregnancy
* Individuals with bleeding disorders
* Tend to heal poorly or form very thick scars called keloids
* Have a lidocaine sensitivity, including those with epilepsy, impaired cardiac conduction, severely impaired hepatic function or severe renal dysfunction.
* Individuals with active inflammation or infection of the skin, including active herpes infection.
* Have a significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation, including history of frequent herpes infections, and subjects planning to be exposed to excessive sun, Ultraviolet lamps and extreme cold weather during the first week after injection.
* History of allergies to gram positive bacterial proteins
* Individuals with who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
* Have an active inflammation or infection of the skin near the site of injection
* Are taking any medications that suppress your immune system
* Have severe allergies to medications or other things that we believe might make participation unsafe for you
* Have a history of connective tissue diseases, such as:

  * rheumatoid arthritis
  * scleroderma
  * polymyositis/dermatomyositis
  * systemic lupus erythematosus (SLE)
Examining Bluetooth Haptic Device Use for Pain and Anxiety Reduction in Vascular Access Procedures

This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.


Eligibility Criteria:
Inclusion Criteria:

* Between age 4-99
* Will undergo a vascular access procedure
* English speaking participant and parent or LAR

Exclusion Criteria:

* Legal guardian not present to obtain consent
* Child is unable to self-report pain or anxiety
* Child with a significant neurological condition, or major developmental disability
* Child with active infection of the hand or arm
* Major surgery within the last 48 hours
Effect of Three Fibres on Glycaemic and Insulinaemic Responses in Healthy Adult Volunteers

The purpose of this study is to determine whether DuPont Experimental Dietary Fibre products 1 and 2 are digested using glycaemic and insulinaemic response as markers.

DuPont Experimental Dietary Fibre products 1 and 2 glycaemic and insulinaemic response will be compared against that of polydextrose and dextrose when given to adult healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18-27 kg/m2.
* Self-diagnosed as healthy at the time of recruitment, confirmed by medical questionnaire: no reported current or previous metabolic diseases or chronic gastrointestinal disorders.
* No blood donations during the study.
* Reported intense sporting activities \< 10hr/w.
* Reported alcohol consumption ≤21 units/w (female volunteers) or ≤28 units/w (male volunteers).
* Feasibility to give blood sample as per study protocol.
* Informed consent signed

Exclusion Criteria:

* Dislike, allergy or intolerance to test products.
* Fasting blood glucose levels \<4.4 or \>6.1.
* Volunteer has any health conditions that would prevent him/her from fulfilling the study requirements, put the subject at risk or would confound the interpretation of the study results as judged by the Principal Investigator.
* Volunteer with history of diabetes and high blood pressure.
* Having consumed anything apart from plain water in the twelve hours prior to the first test day.
* Volunteer and/or immediate family member is an employee of the investigational site directly affiliated with this study, the sponsor or the clinical research organization.
* Reported lactating (or lactating \< 6 weeks ago), pregnant (or pregnant \< 3 months ago) or wish to become pregnant during the study.
* Reported participation in another biomedical trial 1 month before the start of the study.
Long-Term Safety of Drug Eluting Stents in the "Real World" (FReIburger STent Registry)

The FReIburger STent Registry (FRIST) is designed to determine the long term safety and efficacy of Drug Eluting Stents (DES) in a "real-world" patient population requiring stent implantation.

FRIST included patients treated with DES and bare-metal stents (BMS) in the University Hospital of Freiburg, Germany, according to a non-restrictive inclusion criterion, in which virtually all consecutive patient subsets were considered eligible.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients undergoing percutaneous coronary intervention

Exclusion Criteria:

* Patient refusal or inability to provide written informed consent
Effect of Opioid Cessation on Opioid-Induced Esophageal Dysfunction

The purpose of this study is to evaluate the effect of opioid cessation on opioid-induced esophageal dysfunction (OIED).


Eligibility Criteria:
Inclusion Criteria:

- Patients enrolled in the Pain Rehabilitation Center for opioid cessation, with or without esophageal symptoms.

Exclusion Criteria:

* Inability to provide informed consent.
* Patients with previous gastroesophageal surgery or pneumatic dilation.
* Esophageal botulinum toxin injection within the prior 12 months.
* Esophageal stricture
* Achalasia types I and II
* Allergy to Lidocaine or other local anesthetics
* Subjects on anticoagulation
* Bilateral nasal obstruction
* Pregnancy or breast feeding
Safety and Efficacy Study of ChimeriVax™-JE and JE Inactivated Mouse Brain Vaccine in Children of Descending Age

This randomised, double-blind study is to be conducted on 96 subjects at multiple sites in India. Subjects will be enrolled by age group and randomised to either ChimeriVax™-JE (JE-CV) or JE Mouse Brain Derived Vaccine (JE-MBDV). Study consists of a screening period, a treatment period and a 2 year follow-up period.

Primary safety endpoints will be the adverse event (AE) rates 28 days after completion of vaccination course. The primary efficacy endpoints will be the rate of seroconversion 28 days after completing vaccination.


Eligibility Criteria:
Inclusion Criteria:

* All aspects of the Protocol explained and written informed consent obtained from the subject's parent or guardian and assent from the child if ≥ 8 years of age.
* Aged ≥ 9 months to \< 10 years
* In good general health, without significant medical history, physical examination findings, or clinically significant abnormal laboratory results
* Subject had to be available for the study duration for the study duration, including all planned follow-up visits.

Exclusion Criteria:

* A history of vaccination against, or infection with, JE or other flaviviruses (e.g. Kyanasur Forest Disease, West Nile virus, dengue fever). Previous JE vaccination was to be determined by history (interview of subject's parent or guardian) or by inspecting the child's official vaccination record.
* Demonstration of parasitemia on malaria blood smear at Screening.
* History of residence in or travel to a JE-endemic region of India or elsewhere in Asia (for periods of 4 weeks or more).
* hypersensitivity to thimerosal or gelatin
* Have received a transfusion of blood, blood products or serum globulin in the preceding 6 months,
* Have an immunodeficiency or neurological disorder, or take drugs that suppress the immune system,
* Have a history of severe reaction to other vaccines,
* Have a chronic condition requiring medication,
* Intend to travel out of the area during the study period,
* Have spent at least 4 weeks in a JE-endemic region,
* Plan to receive any other vaccination within the double-blind treatment period, or who have received a vaccination in the month preceding Screening,
* Exhibit signs of secondary or tertiary malnutrition,
* Are seropositive to human immunodeficiency virus (HIV), Hepatitis B or C,
* Have malaria infection, or who have a fever within 3 days before vaccination.
* Those with an acute fever, or with previously scheduled vaccinations, may be rescheduled.
* Consideration of the routine immunisation schedule should be made such that it is ensured that routine vaccinations due are either given before entry to the trial, or afterwards if delayed because of the trial.
Optimal Time to Start Antiretroviral Therapy in HIV-infected Adults With Cryptococcal Meningitis

The goal of this randomized clinical trial is to compare early versus standard timing of initiation of antiretroviral therapy (ART) with respect to clearance of Cryptococcus neoformans from cerebrospinal fluid (CSF) among HIV-infected adults with Cryptococcal Meningitis.

The investigators hypothesize that early ART mediates more rapid clearance of C. neoformans from CSF, as manifested by a greater rate of decrease in C. neoformans colony forming units (CFUs) during the first 28 days after initiating antifungal treatment.

Secondary hypotheses are that recovery of pathogen specific cellular immunity directed at C. neoformans, as manifested by increases in the number and function of C. neoformans-specific peripheral blood mononuclear cells is associated with 1) ART and 2) pathogen clearance. In addition, patients randomized to the intervention arm will have more rapid clearance of antigen levels in CSF and serum and will have a lower incidence of grade 3 and 4 Adverse events.


Eligibility Criteria:
Inclusion Criteria:

* HIV 1 infection confirmed by licensed ELISA kit and/or detectable Viral load.
* Confirmed Cryptococcal meningitis on the current admission by India ink or CSF cryptococcal antigen
* ART naive at the time of enrollment
* 21 years old and above
* Ability and willingness to give written informed consent to participate in the study
* Able (as assessed by the patient's medical team)to initiate amphotericin B for cryptococcal meningitis
* Initiated amphotericin B 72 hours or less prior to assessment for enrollment or not on amphotericin B at the time of assessment for enrollment
* Agrees to obtain outpatient care after discharge within 50 kilometers from Princess Marina Hospital,Scottish Livingstone Hospital and Bamalete Lutheran Hospital

Exclusion Criteria:

* Recent (within the past 4 weeks) antifungal use
* Pregnant or breastfeeding
* Initiated anti-tubercular therapy 2 weeks or less prior to assessment for enrollment.
* Bacterial meningitis at the time of assessment for enrollment.
* Recent (within the past 1 month) use of the following:systemic cancer chemotherapy,oral or intravenous corticosteroids or other immunomodulators.
* Judged by study coordinator to be likely to initiate chemotherapy or any other immunomodulatory therapy prior to the 4 week LP.
* Imprisoned.
Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients

The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.

Patients will receive OSI-774 once daily without interruption. There are no pre-determined number of cycles or planned dose interruptions. For the purposes of evaluation, toxicity and efficacy, a four week (28 day period) will be considered 1 cycle.

Patients will continue to receive OSI-774 until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study.

Patients will have radiographic evaluations after every two cycles of therapy. After cycle 2, patients will also be evaluated by FDG-PET scanning.

Patients will also be asked to fill out a Lung Cancer Symptom Scale (LCSS) on the first day of each cycle.

Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age: 70 years of age or older
* Stage IV or IIIB non-small cell lung cancer (NSCLC)
* Measurable tumor(s)
* Three or more weeks since prior radiation therapy
* Three or more weeks since prior major surgery
* Must at least be able to walk and capable of taking care of oneself although unable to carry out work activities.
* Must be up and about more than 50% of waking hours.
* Life expectancy of 8 weeks or more
* Blood tests that show kidneys, liver and bone marrow to be working adequately
* Completely healed from previous oncologic or other major surgery

Exclusion Criteria:

* Prior chemotherapy regimen for non-small cell lung cancer
* Prior exposure to OSI-774 or similar treatments such as trastuzumab, ZD1839, C225, etc.
* Uncontrolled central nervous system metastases
* Concurrent active cancer
* Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
* Prior chemotherapy for any malignant disease
* Difficulty swallowing
* A disease or disorder that interferes with ability to digest and absorb food
* A medical condition that could make it unsafe for patient to participate in this study
CRM and Fusion Beats: Effects of Progressive Fusion on Intra-left Ventricular Mechanical Function

This study is looking at cardiac rhythm management (CRM) and fusion beats in patients who have a pacemaker or implantable cardioverter-defibrillator (ICD), to determine if there is a correlation between the time between the contraction of the upper chambers of the heart (atrium) and the lower chambers of the heart, (ventricle) and heart function.

Some studies of people with pacemakers have been done to determine if shortening the time of contraction between the atrium and ventricle could benefit the function of the left ventricle. These studies have shown that there is no benefit in heart function.There have been other studies which have shown that chronic pacing of the right ventricle, especially with the lead placed at the tip of the right ventricle, can lead to a decrease in the function of the left ventricle and congestive heart failure. In some patients long term pacing of the right ventricle has also been associated with a reduction in the ability of the left ventricle to pump blood. This is know as a reduced left ventricular ejection fraction, which can be documented by an echocardiogram.

This study proposes to evaluate the acute effects of progressive paced fusion beats on the left ventricle to answer the question whether there is an delay between the atrium and ventricle that is "too long" or "too short".


Eligibility Criteria:
Inclusion Criteria:

* Dual chamber pacemaker or ICD device
* Left Ventrical Ejection Fraction (LVEF) 40% or less
* Sinus Rhythm with intact atrioventricular conduction with a PR interval greater than 200 msec QRS less than 120 msec
* Pacing right ventricle lead in the right ventricular apex (RVA), system implanted within 6 weeks or chronically implanted system with histograms showing 20% or less right ventricle pacing

Exclusion Criteria:

* LVEF greater than 40%,
* Any rhythm other than sinus rhythm
* Second degree or higher atrioventricular block
* Native Heart Rate less than 40 beats per minute or greater than 90 beats per minute
* Left ventricle or Chronic Sinus lead in non-RVA location
* Chronically implanted system with greater than 20% right ventricle pacing
Topical Ascorbic Acid for Treatment of Squamous Cell Skin Cancer

Randomized comparative trial of a 30% solution of ascorbic acid in 95% dimethylsulfoxide applied topically twice a day for 8 weeks vs 5% imiquimod cream in the treatment of biopsy proven squamous cell carcinomas of the skin in otherwise healthy adult patients. Outcome measure was biopsy proven resolution of the carcinoma.

Importance:

Skin cancer is the most common cancer in the United States, with more people diagnosed each year than all other cancers combined. Basal cell and squamous cell cancers are the most common forms with an estimated 6-7 million cases diagnosed annually. Costs of treating these cancers in the U.S. are estimated at $9-10 billion annually. Task force consensus guidelines suggest Mohs surgery as the treatment of choice, and as the single most precise and effective treatment method. However, cost and issues of cosmesis are principal disadvantages. Previous studies show the effectiveness of a topical solution of ascorbic acid in the treatment of BCC. This study extends previous work to evaluate efficacy in the treatment of SCC of the skin.

Objective:

To evaluate efficacy of a therapeutic regimen in treating squamous cell cancer, consisting of 30% ascorbic acid in 95% dimethylsulfoxide topically applied at home by patients twice a day for 8 weeks, vs 5% imiquimod cream which is an FDA approved treatment for SCC.

Design, Setting, and Participants:

This study was carried out in accordance with principles of the Declaration of Helsinki. Detailed informed consent was obtained from each patient.

Eligible participants of any age had histologically confirmed primary, previously untreated, nodular or superficial SCC. Patients with cancers larger than 2 cm or deeper than 2 mm were excluded from the study. Imiquimod was applied once daily for 5 days per week as per manufacturer instructions for treatment of SCC. Patients were randomly assigned to treatment group. Participants and outcome assessors were blinded to treatment protocol. Patients were seen at initial visit, 4 weeks, 8 weeks, and six weeks after treatment conclusion for final biopsy. The AA treatment was a solution while the IMQ a cream, however participants were simply told they would be receiving a topical treatment with instructions on how to apply, thus the blinding was intact.

Main Outcomes and Measures Number of lesions out that were cancer free after 8 wks of treatment.

Eligibility Criteria:
Inclusion Criteria: Presence of biopsy proven squamous cell cancer of the skin -

Exclusion Criteria: Previous history of malignancy, diabetes, immunocompromised

-
An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.

The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

- Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications:

Evaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening

* At least 18 years of age
* Otherwise in good health, as determined by physical exam and medical history
* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration
* Subjects who are undergoing colonoscopy for foreign body removal and decompression
* Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics
* Subjects who are taking drugs that may affect electrolyte levels
* Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study
* Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia
* Subjects who are pregnant or lactating, or intending to become pregnant during the study
* Subjects of childbearing potential who refuse a pregnancy test
* Subjects who are allergic to any preparation components
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
Study to Evaluate the Efficacy and Safety of Subcutaneous Sonelokimab Compared with Placebo in Adult Participants with Moderate to Severe Hidradenitis Suppurativa

This is a study to evaluate the clinical efficacy and safety of sonelokimab administered subcutaneously compared with placebo in the treatment of adult participants with moderate to severe hidradenitis suppurativa. Participants will be randomized 2:1 to either sonelokimab or matching placebo up to Week 16.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be at least 18 years of age at the time of signing the informed consent.
2. Participants who are diagnosed with hidradenitis suppurativa as determined by the investigator and have a history of signs and symptoms of hidradenitis suppurativa for at least 6 months before signing the informed consent.
3. Participants who have had an inadequate response to appropriate systemic antibiotics for treatment of hidradenitis suppurativa (or demonstrated intolerance to, or had a contraindication to, systemic antibiotics for treatment of their HS), in the investigator's opinion.
4. Participants who have a total AN count of ≥5.
5. Participants who have HS lesions present in ≥2 distinct anatomical areas, at least one of which must contain single or multiple fistulas (ie, be Hurley Stage II or III).

Exclusion Criteria:

1. Participants with a known hypersensitivity to sonelokimab or any of its excipients.
2. Participants with any other active skin disease or condition that may, in the opinion of the investigator, interfere with the assessment of HS.
3. Participants with underlying conditions that, in the opinion of the investigator, potentially places the participant at unacceptable risk.
4. Participants with current severe or uncontrolled disease(s) that put(s) the participant at increased risk in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.
5. Participants with any other known autoimmune disease or any medical condition that in the opinion of the investigator would interfere with an accurate assessment of clinical symptoms of HS.
6. Participants with a gastrointestinal condition including inflammatory bowel disease or diagnosis of ulcerative colitis or Crohn's disease.