cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of AN2728 Topical Ointment to Treat Adolescents With Atopic Dermatitis

The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with atopic dermatitis (AD)


Eligibility Criteria:
Inclusion Criteria:

* Male or female 12 to 17 years of age, inclusive
* Clinical diagnosis of atopic dermatitis (according to the criteria of Hanifin and Rajka)
* Total body surface area (BSA) of atopic dermatitis involvement ≤35%
* Presence of two comparable target lesions
* Willing and able to comply with study instructions and commit to attending all visits
* Females of childbearing potential must use a highly effective method of birth control. Males with partners of childbearing potential should inform them of their participation in this clinical study and use a highly effective method of birth control during the study.
* Parent/guardian has the ability to understand, agree to and sign the study Informed Consent Form (ICF) prior to initiation of any protocol-related procedures; subject has the ability to give assent

Exclusion Criteria:

* Significant confounding conditions as assessed by study doctor
* Unstable or actively infected AD
* Active or potentially recurrent dermatologic condition other than atopic dermatitis in the target lesion area that may confound evaluation
* History or evidence of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis)
* Concurrent or recent use of certain topical or systemic medications or phototherapy without a sufficient washout period
* Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within the last 5 years
* Current pregnancy or lactation, or intent to become pregnant during the study
* Known sensitivity to any of the components of the study drug
* Participated in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study
* Participated in a previous AN2728 clinical study
Effect of the Use of Simulation (Video) on the Oral Hygiene

The care of the oral cavity is an important way to prevent local and systemic infections. This study aimed to: evaluate the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy. The methodological design used was quasi-experimental before-after intervention. The sample consisted of 23 subjects who performed the technique of oral hygiene before and after watching an educational video. To do so was given a kit with a toothbrush with soft bristles, toothpaste with low abrasivity, mouthwash or product to mouthwash and dental floss for oral hygiene. For data analysis we applied the parametric test t "Student" paired.

General Purpose Evaluating the use of video as a teaching strategy of oral hygiene for patients undergoing chemotherapy.

Specific Objectives Assess the steps taken by the subjects to oral hygiene before (initial performance) and after (final performance) exposure to an educational video on oral hygiene; To investigate the effect of an educational video on oral hygiene in this clientele; Identify patient acceptance of the teaching method employed.

Methods and Procedures Delineation The research was quasi-experimental in nature, before-after intervention (the intervention in this study was the teaching learning strategy employed used an educational video on oral hygiene.) Patients will be evaluated individually, before and after exposure to video. It is not foreseen monitoring at other times.

Eligibility Criteria:
Inclusion Criteria:

* Physical conditions for self-care during the oral hygiene;
* Score less than or equal to three according to scale performance general condition was drafted and approved by the American Eastern Cooperative Oncology Group (ECOG)
* Accept oral diet
* Lack of nasal catheter or probe nasogastric and nasoenteric
* Present platelet counts \> 20,000 mm3
* Neutrophils \> 1,000 mm3
* Absence of pathologies or buccal devices which prevent attainment the procedure
* The presence of teeth
A Medical Assistant-Based Program to Promote Healthy Behaviors in Primary Care

The purpose of the study is to determine whether a program of screening and intervention for four health risk behaviors (smoking, problem drinking, sedentary lifestyle, unhealthy diet) carried out by medical assistants in primary care practices can help patients improve their behaviors. The hypothesis is that patients who receive the intervention will demonstrate higher rates of health behavior change than patients who receive usual care.

Unhealthy behaviors are the most common actual causes of death in the United States. The high prevalence of behavioral risk factors in primary care calls for a response of appropriate scale. One strategy to achieve a greater scale of delivering interventions is to relieve the bottleneck of physician assessment and management. Creating a system that engages other members of the primary care team to link patients who are ready to change with practice, health system and community resources is a mechanism to amplify the practice's impact and thus achieve the necessary scale.

The project evaluates a model of primary care that manages population risk with appropriate expertise at the necessary scale. We test the effectiveness of a medical assistant-based program to link patients with behavioral risk factors to interventions at the practice, health system, and community levels. We hypothesize that intervention-group patients will achieve higher rates of behavior change than control patients.

The study is a controlled trial in the PRENSA network, which includes six urban practices serving a disadvantaged Latino population. Using data from a health risk assessment (HRA) routinely collected in PRENSA practices, medical assistants will assess 4500 patients' behavioral risks and apply behavior-specific "assess-advise-agree-assist-arrange" algorithms to engage behavioral interventions in the practices, health system, and local public health department. Outcomes data will be collected at 6-9 month follow-up with repeated completion of a standardized health risk assessment. The primary analyses will compare outcome measures for smoking, problem drinking, sedentary lifestyle, and unhealthy diet in intervention and control patients.

We anticipate the study will show a medical assistant-based program to address smoking, risky drinking, sedentary living, and unhealthy diet in primary care to be feasible and effective. We will evaluate program effectiveness by assessing the number of patients reached, interventions requested and completed, impact on medical assistant workflow and satisfaction, costs to the practices, and impact on health behaviors.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over
* Uninsured, enrolled in Bexar County CareLink program
* Has completed baseline Health Risk Assessment

Exclusion Criteria:

* Unwillingness to participate
A Clinical Study, to Evaluate the Safety and Tolerability of Intradermal IMM-101 in Adult Melanoma Cancer Patients

To evaluate the safety and tolerability of intradermal injections of IMM-101 (Heat-killed Mycobacterium obuense) in melanoma cancer patients.

The proposed study is a first-in-man, placebo-controlled, dose escalation trial to evaluate the safety and tolerability of three different doses of IMM-101 administered intradermally to melanoma patients. Additionally, the study aims to characterize local responses to this vaccine in order to delineate unexpected / unacceptable local reactions from those indicative of appropriate immunological response in this patient group.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of disease free stage III or stage IV melanoma (with or without metastases) or stable disease (if with metastases) and receiving no other treatment
* willing to use effective contraception for the duration of the study
* able to comply with the requirement to complete a diary card

Exclusion Criteria:

* Pregnant or lactating females
* Major surgery within the 14 days preceding the screening visit
* Suspicion of a previous infection with mycobacteria including previous tuberculosis (TB) prophylaxis
* Treatment with another investigational medicinal product within the last 30 days prior to the screening visit
* Previous treatment with M. vaccae
* Exposure to Bacille Calmette Guérin vaccine (BCG) within the last 12 months
* Concurrent uses of drugs likely to reduce inflammation at the local injection site or dampen/modulate the immune system
* Depot injection of corticosteroids within 6 weeks of the screening visit or chronic systemic corticosteroids in the 2 weeks prior to the screening visit
* Ongoing treatment with radiotherapy, cytotoxic chemotherapy or chemotherapy in the last 30 days prior to the screening visit
Regional Distribution of Ventilation at Different Respiratory Rates

This study will investigate the distribution of gas during mechanical ventilation in patients undergoing robot assisted laparoscopic prostatectomy. The gas distribution of ventilation are monitored and data extracted using electric impedance tomography in different respiratory rates.

Mechanical ventilation during anaesthesia and intensive care often results in an uneven gas distribution of ventilation. Patients anaesthetized for laparoscopic surgery and patients positioned i a Trendelenburg position is particularly at risk.

A less harmful mode of ventilation could possible lead to a more optimal ventilation with avoidance of ventilator induced lung injuries. The project will investigate if volume controlled ventilation with a higher respiratory frequency can be used in this purpose.

The researchers intend to investigate patients, without previously known lung disease, undergoing robot-assisted laparoscopic prostatectomy. After the patients have given informed consent, they will be included in the project. The distribution of ventilation will be monitored with electric impedance tomography (EIT). Once the patients have been anaesthetized, positioned with the head down and the surgical procedure have been started with insufflation of carbon dioxide we will start our test.

The investigators will perform three episodes of standardized ventilation with the respiratory rate (RR) of 20, 40 and 60. With a higher RR the tidal volume will be reduced tom maintain a constant inhaled minute volume. Data will be collected from the EIT-equipment, the anaesthesia machine and the monitoring system.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for robot-assisted laparoscopic prostatectomy
* \> 18 years
* Consent to take part in the study

Exclusion Criteria:

* Impaired cognitive function
* Previously known lung disease
* Insufficient skills in Swedish language to understand information about the study
Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection

Clostridium difficile (C. difficile) can cause symptoms ranging from mild diarrhea to life-threatening colitis. Illness from C. difficile most commonly affects patients in hospitals and long-term care facilities and typically occurs after a patient has received antibiotics.

In vitro data indicate Calcium Aluminosilicate Anti-Diarrheal (CASAD) has the potential to bind TNFα, IL-1, IL-6, and IL-10 in the intestines and, therefore, may act to reduce severity of fever, leukocytosis, and bowel injury in patients with C. difficile infection. This would likely occur in conjunction with neutralization of C. difficile toxins A\&B by CASAD. Computer modeling of CASAD performed by Phillips et al. at Texas A\&M University supports this hypothesis.

The investigators hypothesize that adding CASAD 1.5 grams po tid to any standard-of-care therapy will reduce the duration and severity of diarrhea and other symptoms in patients with C. difficile infection.


Eligibility Criteria:
Inclusion Criteria:

* C. difficile-associated diarrhea at the time of enrollment
* 18 years old and up
* Ability to take oral medications
* Negative urine pregnancy test for women of childbearing age
* Must have the ability to understand and the willingness to provide a written informed consent to participate in the study

Exclusion Criteria:

* History of known allergy to silicates
* Patients with signs of toxic megacolon, peritonitis, pseudomembranous colitis or bowel perforation
* Patients with hypotension (systolic blood pressure \< 90 mm Hg) or septic shock requiring pressors
* Patients with other known causes of diarrhea or colitis
* Pregnancy or lactation
* History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up
* Participation in any other study where the subject is actively taking investigational medication within the last 30 days
* More than 5 doses of metronidazole or oral vancomycin prior to starting on study drug for the current C. difficile diagnosis. Administration of metronidazole or oral vancomycin for treatment of prior C. difficile diagnosis is not exclusionary as some patients may be experiencing a relapse of C. difficile.
* Any other antibiotic, toxin-binding agent or fecal transplant used for the treatment of C. difficile prior to or added to the subject's standard-of-care treatment regimen. Use of intravenous vancomycin is not exclusionary.
Transepithelial Corneal Collagen Cross-linking (CXL) in Treatment of Keratoconus

Transepithelial CXL (performed without epithelial removal) seem to have similar clinical effect on keratoconic eyes compared to the standard CXL (which includes epithelial removal). The current study attempts to prove that hypothesis.

A prospective, controlled, randomized, contralateral trial, will involve one eye of the patient to be treated with transepithelial CXL, while the control eye will be treated with the standard CXL. Totally 20 patients (age \>18 and \<40 years) referred by an ophthalmologist to the eye department of the University Hospital North Norway for CXL treatment of bilateral progressive keratoconus, will be recruited.

CXL appears to hinder the development of keratoconus by strengthening the cross-bindings in the corneal stroma with a resultant increase in corneal biomechanical strength of up to 300%. The method was introduced in the mid-nineties and has been approved for use in the EU countries since 2007. Standard treatment protocol, involving the removal of the corneal epithelium before the Riboflavin application, has been used. In order to avoid potential complications following removal of the epithelium (infection, delayed healing, scar formation, as well as discomfort and pain), a modified procedure where the epithelium is kept intact, so called transepithelial CXL, has been suggested. According to the preliminary results of the published retrospective studies, no significant difference in the clinical effect between the standard CXL with epithelial removal and the transepithelial CXL was found.

Eligibility Criteria:
Inclusion Criteria:

* Documented keratoconus progression in both eyes during the last 12 months before the treatment - decrease in best spectacle-corrected visual acuity (BSCVA) and/or increase in cornea curvature or asymmetry
* Corneal thickness ≥400μm at the thinnest point
* Age range from 18 to 40
* Amsler-Krumeich classification graded stage I to III

Exclusion Criteria:

* Corneal thickness \<400μm at the thinnest point
* History of viral keratitis
* Severe dry eye
* Concurrent corneal infections
* Previous ocular surgery
* Hard contact lens wear for ≤4 weeks before baseline examination
Transdermal Contraceptive Delivery System (TCDS), Also Known as AG200-15 Patch Arm

The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Eligibility Criteria:
Inclusion Criteria:

* sexually active women requesting contraception
* Regular menses every 24 - 35 days
* In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values

Exclusion Criteria:

* Known or suspected pregnancy
* Lactating women
* Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
* Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
* Use of other contraceptive methods than study medication
Cash Plus Interventions for Prevention of Acute Malnutrition in Children Under 5 and Their Mothers in Somalia

This trial studied different combinations of cash assistance to families that live in food insecure areas of Somalia and aimed to understand if this cash assistance provided reduced malnutrition of children and mothers.

This study was a mixed-methods cluster-randomized controlled trial implemented in the Bay and Hiran regions of Somalia to study monthly cash assistance interventions across 3 study arms. The intervention was provided for 6 months and included cash plus social and behavior change communication intervention. The investigators studied which combination of assistance was most effective and cost-effective at reducing and preventing child and maternal malnutrition (wasting, stunting, etc.). Enrolled participants were children under 5 and mothers of children under 5. The investigators collected qualitative, quantitative, and cost data to study the intervention across study arms, household experiences with receiving cash, and household factors related to malnutrition. Quantitative household data and anthropometry was collected at baseline, 3 months, and 6 months. Qualitative data was collected through focus group discussions on health/nutrition topics with mothers and fathers of children under 5 who participated in the study. Cost data was collected in consultation with study and program staff to evaluate the cost-efficiency, cost-effectiveness, and societal costs of the intervention. Investigators also monitored the local markets for food availability and price fluctuations to understand its impact on malnutrition in the communities where the trial was being implemented.

Eligibility Criteria:
Inclusion Criteria for Child Participants:

* Enrolled in Save the Children Cash Plus for Nutrition Program
* Ages 6-59 months at baseline
* Mother is enrolled in the study

Exclusion Criteria for Child Participants:

* Received treatment for wasting at baseline
* Had an episode of severe acute malnutrition in the past 12 months

Inclusion Criteria for Mothers:

* Enrolled in Save the Children Cash Plus for Nutrition Program
* At least 18 years old at baseline
* Have a child that is 6-59 months old at baseline
* Voluntarily willing to participant through signed consent form.

Exclusion Criteria for Mothers:

* Currently receiving treatment for wasting
* Had an episode of severe acute malnutrition in the past 12 months
Rapid Versus Prolonged Inpatient Up-Titration of Captopril

The primary objective of this study is to establish a safe and effective method of up-titration of captopril for hospital inpatients.

Angiotensin converting enzyme inhibitors (ACEi) are one of the most frequently prescribed pediatric cardiac medication and overall their safety in children is widely accepted. Pediatric formulary recommendations for ACEi suggest starting with a low initial dose (0.1 mg/kg), to avoid hypotension, and up-titration for a maintenance dose. However, side ranges are quoted for maintenance doses and no guidance is given as to the best method of up-titration, The physician is left uncertain of the optimal dose and how best to achieve it.

The ultimate goal of this study is to be in a position to provide physicians caring for children with heart disease information about how to safely up-titrate this widely used medication, and by doing so to improve dosing in the wider pediatric population.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric cardiology in-patients at The Hospital for Sick Children
* Primary physician has decided to commence ACEi (the division has agreed that our institutional choice will be to start patients on captopril and up-titrate to optimal dose before converting to other ACEi)
* Patients who have been initiated on captopril within the prior 24 hours, but have not yet started up-titration, will be eligible to be randomized

Exclusion Criteria:

* Known sensitivity to ACEi
* Infants on the neonatal intensive care unit
* Treatment with any ACEi for more than 24 hours within the preceding 6 months
* Age \> 18 years
Genotype-guided Versus Standard for Warfarin Dosing

To compare the efficiency and safety between gene-oriented group and standard care group during 90 days of initial warfarin-treatment for requiring anticoagulation patients with valve replacement or atrial fibrillation with or without valvular heart disease。

Due to narrow therapeutic window, and individual differences in dosage, inappropriate use of warfarin may lead to serious complications and ineffective. Based on the results of the research on the transformation of warfarin pharmacogenomics, this study investigates the clinical application of gene-directed warfarin dose prediction model through the preset dosage regimen of warfarin during the initial treatment phase. Compared with the conventional treatment, that is to say empirical medication, this study is to verify the feasibility and value of gene-oriented warfarin dose prediction model, in order to establish a practical guidance to optimize the rational use of warfarin treatment program, to enable patients to obtain effective, safe warfarin dose, and to achieve the established anticoagulant strength faster and safer, as the same time, to reduce the times of patients was blood and the incidence of bleeding/embolism, and to save costs and ensure the safety of warfarin clinical medication.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 18 to 70 years old, requiring anticoagulation because of valvular or non-valvular atrial fibrillation or after valvular replacement. Patients could visit to be followed up in our hospital clinic regularly and agree to participate in the clinical trial and sign a written informed consent.

Exclusion Criteria:

* Patients will be excluded from the trial if aged \<18 years old or \> 75 years old, pregnant and lactating, if treated tricuspid valve replacement, or coronary artery bypass grafting before, if diagnosed with congenital heart disease, if known their CYP2C9 or VKORC1 genotype, if taken dicoumarol drugs previously or taking them now, if not suitable for enrollment judged by researchers.
Analgesia After Video-Assisted Thoracic Surgery

Although less invasive, postoperative analgesia remains challenging in patients undergoing uniportal video-assisted thoracic surgery (VATS).

Although less invasive, postoperative analgesia remains challenging in patients undergoing uniportal video-assisted thoracic surgery (VATS).

Adequate postoperative pain relief is imperative to hasten functional recovery, accelerate discharge from the hospital, and reduce chronic postsurgical pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for uniportal VATS under general anesthesia, ASA status I-III, aged from 18 to 70 years old of both sex.

Exclusion Criteria:

* Contraindications to regional block
* Pregnancy
* Body mass index (BMI) \> 30 Kg/m2
* Psychiatric diseases
* Severe renal, liver, or cardiac dysfunction