cyrilzakka/clinical-trials huggingface dataset:
Ozonated Olive Oil in Treatment of Pemphigus Vulgaris and Bullous Pemphigoid

This study assesses the disinfectant and healing promoting effect of ozonated olive oil in treatment of pemphigus vulgaris and bullous pemphigoid in comparison to conventional topical treatment with topical antibiotic.

All participants will be subjected to the following:

* Written informed consent.
* Detailed history and clinical examination and photographic documentation
* Patients with pemphigus vulgaris (epidermal skin blisters) as well as those with bullous pemphigoid (subepidermal skin blisters) will receive systemic treatment, namely; pulse steroid therapy and either mycophenolate mofetil or azathioprine

  +/- monthly IV cyclophosphamide.
* Two comparable contralateral lesions will be selected in every patient, which will be randomly assigned to either ozonated oil or conventional treatment.
* Patients will apply ozonated oil to on one lesion followed by gauze compared to conventional topical gentamycin and potassium permanganate followed by gauze on the contralateral lesion. Role of topical treatment is essentially to prevent / treat secondary bacterial infection of skin erosions as well as promote wound healing by maintaining moist clean environment.
* Surface area of both lesions will be calculated using digital planimetry, prior to starting treatment and by the end of treatment; namely end of the first cycle of intravenous pulse steroids on day 6 which defines end of intervention. Percent reduction on either side will be calculated.
* For assessing disinfectant effect, swabs will be taken from the 2 selected lesions at the same intervals for assessing for bacterial as well as fungal growth.
* Patients with positive cultures for bacterial growth will be given systemic antibiotics according to culture and sensitivity

Eligibility Criteria:
Inclusion Criteria:

Pemphigus vulgaris or Bullous pemphigoid with bilateral skin erosions.

Exclusion Criteria:

- Age \< 18 years . Pregnant/ lactating females.
Influence of a Brief Intervention on CRC Screening

Qualitative data were collected from 5 General Practionners (GPs) focus groups, 24 patient interviews and 35 recorded consultations from 9 GPs to explore colorectal cancer (CRC) screening in France The qualitative data indicated that improvement was needed in patient-centered communication. Educational material was developed based on these triangulated data with two different scenarios to improve communication with patients: one for a compliant patient, another for a non compliant patient The hypothesis is that a brief intervention on GPs can improve the patients' participation rate to colorectal screening

Method : cluster randomized control trial (cluster unit : GPs practices) With a brief intervention on a randomized population of GPs in the district of Val d'Oise Inclusion criteria: GPs with a practice in the district of Val d'Oise and active in the colorectal mass screening

a cluster randomized controlled parallel groups study was conducted in the Val d'Oise department in France All practices of the Val d'Oise department were eligible to participate. Among 585 practices, an independent biostatistician randomized 50 practices per arm in October 2011 according to a computer generated randomization list.Two team members phone called all the GPS of the randomized practices.

GPs from practices in the control group are asked to continue their usual care, as if they were not participating in this trial. GPs of both groups had to send their patients list to the research team to calculate their eligible population. They were also asked to list all the gFOBT delivered during the six months period of the study.

GPs of the intervention group received a four hours educational training focused on patients' centered care.

Eligibility Criteria:
Inclusion Criteria:

Inclusion of GPs practices: All GPs practices of the Val d'Oise department in France were eligible to participate GPs using complementary therapies occasionally were allowed to participate

Exclusion Criteria:

Exclusion of GPs practices : practices were excluded when doctors used exclusively complementary therapies (acupuncture therapy, homeopathy....)

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Efficacy and Safety of a New Botulinum Toxin Type A for Treatment of Facial Expression Lines

The dermatological treatment for reducing facial wrinkles with injectable drug Botulift (botulinum toxin type A - Laboratório Químico Farmacêutico BergamoLtd.) has a not inferior activity when compared with Botox ® (botulinum toxin - Allergan Inc.) in clinical trials.

The study will evaluate non-inferiority in clinical improvement in the intensity of expression lines over 16 weeks of drug Botulift (Laboratório Químico Farmacêutico Bergamo Ltd.) compared with Botox ® (Allergan Inc.). So that the homogeneity of the group opted to use in female patients with glabellar wrinkles grade 2 (moderate) and 3 (severe) Scale Standard Facial Wrinkles, established by Honecker et al. (2003). The first area of the face perceived in mime is the glabellar complex, located in the space between the eyebrows, wrinkles eventually show (Almeida et al., 2010).

Patients will be evaluated at each visit, the doctor Principal Investigator and digital photos of the glabellar region at maximum contraction and relaxation will be obtained using the apparatus Visia (Canfield Imaging Systems, version 4.0.2) for further analysis by random team dermatologists.

Eligibility Criteria:
Inclusion Criteria:

* Patients who agree with all study procedures and sign for their own free will the TCLE;
* Adult patients were female between 18 and 65 years, regardless of social condition;
* between skin phototype I and IV;
* With good mental and physical health;
* Patients who have not been treated with botulinum toxin type A;
* Patients who agree to abstain from physical activity for a period of 24 hours, previous and subsequent to the initiation of the study;
* Patients presenting at screening visit, wrinkles in the glabellar region between classes 2 and 3 of Table Wrinkles Pattern Classification, which is diagnosed clinically by the dermatologist.

Exclusion Criteria:

* Patients who are in classes 0 and 1 of the Table Pattern Classification Wrinkle;
* Patients who have disorders or diseases that might interfere with neuromuscular function (myasthenia gravis or Lambert-Eaton syndrome);
* Patients being treated with antibiotics (aminoglycosides) and muscle relaxants;
* Patients with pre-existing conditions such as ptosis or scars in the area to be assessed, as they may endanger the health of the patient and the results of the study;
* Patients who have made treatments fill in the glabellar region (retinoic acid, collagen);
* Patients who have been treated in the dermatological peeling úlitmos three months;
* Patients are using treatments dermacosmetics agents anti age (vitamin C pure retinoids flavanoids acid hyaluronic others) or used past 3 months
* Patients with known hypersensitivity to any component of the study drug;
* Pregnant or lactating women;
Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects

This is a multicentre, 2-part, single-blind, randomised, withdrawal, placebo-controlled study, that includes a 4-week patiromer treatment phase (Part A) followed by an 8-week randomised placebo-controlled withdrawal phase (Part B) and a 2-week follow-up period.

In Part A, participants who meet all eligibility criteria will initiate patiromer at an oral dose of 8.4 g (1 packet/day). The dose will be adjusted based on the serum potassium (sK+) levels.

After the completion of part A, all the participants who meet the eligibility criteria for Part B will be randomised to receive patiromer or placebo. Participants will start Part B with the same dose of patiromer they were receiving at the end Part A. However, Patiromer dose may be up- or down-titrated based on sK+ levels.

The primary objectives of the study are:

Part A - To evaluate the efficacy of patiromer for the treatment of hyperkalemia in Chinese subjects.

Part B - To evaluate the effect of withdrawing patiromer on sK+ control. To determine if the treatment with patiromer will result in continued use of renin-angiotensin-aldosterone system inhibitor (RAASi) medications.

Eligibility Criteria:
Inclusion Criteria:

* Chinese subjects at least 18 years of age.
* Chronic Kidney Disease (CKD) stage 3 and 4.
* Mean of 2 measurement of serum potassium higher than 5.0 and lower than 6.5 mEq/L at baseline.
* Subjects on any stable dose of at least 1 RAASi medication for at least 28 days before Day 0/baseline.
* If on antihypertensive medication, have a stable dose for 28 days before Day 0/baseline.
* Women of childbearing potential must agree to continue using contraception throughout the study and for 4 weeks after study completion.

Exclusion Criteria:

* Any level of hyperkalemia at Day 0/baseline that, in the opinion of the Investigator, requires emergency intervention.
* Type 1 diabetes or Type 2 diabetes mellitus with glycated haemoglobin (Hb A1c) higher than 10.0% at screening/Part A baseline.
* History of acute renal insufficiency in the past 3 months prior to the beginning of the study.
* Diseases affecting the hearth muscle and heart's ability to pump blood around the body
* Major surgery including thoracic and cardiac within 3 months prior to the beginning of the study or anticipated need during study participation.
* Heart or kidney transplant recipient or anticipated need for transplant during study participation
* Diagnosis or treatment of a malignancy in the past 2 years before Day 0/baseline.
* Use of potassium supplements, bicarbonate or baking soda in the last 7 days prior to Day 0/baseline.
* Pregnant women or breastfeeding.
Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance

The primary objective of this study is to measure and compare the acute effects of rupatadine 10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers' performance on a standard over-the-road driving test and a car-following test.

The study shall be conducted according to a three-way, double-blind, placebo and active controlled crossover design. Treatment groups are identified as follows.

* Rupatadine
* Hydroxyzine
* Placebo

Eligibility Criteria:
Inclusion Criteria:

1. Normal healthy males or females
2. Subjects must be experienced drivers.
3. Vision: normal binocular acuity, corrected, or uncorrected.

Exclusion Criteria:

1. Pregnant or nursing females.
The Provider and Organization in Asthma Guidelines

The purpose of this study is to examine the interaction between the personal attributes of clinicians and the organizations in which they work and the effect of interventions on their ability to implement an asthma disease management program. +

Less than 20% of primary care providers adhere to national asthma guidelines. Interventions to improve provider adherence to guidelines have had modest success. We believe that changing provider behavior must be viewed in the context of the provider's environment. We hypothesize that providers who are most successful in implementing and sustaining asthma management programs will have a set of personal attributes, related to asthma, characterized by readiness to change, high self-efficacy, positive outcome expectancies and high outcome value AND will work within organizations that facilitate and support such activities. We propose a two phase study. In Phase 1 (Year 1) survey instrument development and testing and provider meetings to discuss the interventions will occur. Providers in 49 practices/clinics that are using an asthma management program called Easy Breathing, will complete these surveys that will characterize the organization and organizational culture of the clinics/practices and the provider personal attributes surrounding asthma. In Years 2-5, a randomized, controlled study of either a behavioral intervention, an organizational intervention or no intervention (control) will be performed in 36 of these clinics/practices. Clinics/practices in the behavioral arm will receive an intervention consisting of expert modeling, program-, clinic- and provider-specific feedback, and use of opinion leaders and academic detailing. Clinics/practices in the organizational arm will receive an intervention consisting of benchmarking, leadership capability training and team building and incentives/ rewards. The primary outcome variable is the number of Easy Breathing surveys completed by provider and by clinic/unit of time. We have previously shown that enrollment in Easy Breathing (which was adapted directly from the national asthma guidelines) as demonstrated by completion of a survey is a surrogate indicator of inhaled corticosteroid use and is associated with decreased medical services utilization. This study will thus investigate the complex interactions between provider personal attributes and the organization and the effect of targeted interventions on provider performance to implement an asthma disease management program. These data will then be used in future studies to determine how to better tailor interventions in a cost constrained environment.

Eligibility Criteria:
Inclusion Criteria:

* Must have used Easy Breathing Disease Management Program for more than one year.

Exclusion Criteria:

* None
Weight Loss Management in Endometrial Cancer Survivors

This study is being done to understand how oncologists can engage a multidisciplinary team to help endometrial cancer survivors with obesity to engage in a weight management program and potentially start a weight loss medication. Obesity often impacts the future health and longevity of early-stage endometrial cancer survivors more than their cancer diagnosis.

Patients will be referred to the KUMC OB/Gyn weight management clinic to discuss weight management options.

* If patients decide to use medications for weight loss, then the study will collect data from their chart that is recorded as part of routine monitoring for patients on weight loss medications.
* If patients decide not to use any medications, the study will monitor physical exam and lab data collected as part of their routine medical care.

The study will also try to understand reasons why patients did or did not start using a weight loss medication.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* ECOG 0-2
* BMI ≥ 30kg/m2
* Completed surgical staging with no evidence of residual disease
* Endometrioid endometrial adenocarcinoma, p53 wild type
* Stage 1
* Undergoing active surveillance +/- brachytherapy

Exclusion Criteria:

* Unable to participate in behavior weight loss
* Stroke, heart attack, end stage liver disease, or end stage kidney disease during the last 6 months.
* Currently on a GLP-1 agonist
* Currently on insulin
How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?

Cervical stenosis may occur in up to 19% after conization. It is a cause of infertility and amenorrhea. This study will test a new device named DUDA Device ("Dispositivo Uterino para dilatar canal endocervical") placed just after the conization, in order to evaluate the safety, efficacy and quality of life.

This device has the potential to improve outcomes by means of a significant stenosis reduction and maintain patency of the endocervical canal to view the squamo-columnar junction (SCJ) of the cervix during follow-up of this patient.

Eligibility Criteria:
Inclusion Criteria:

* High Grade Cervical Dysplasia, Grades 2 and 3, in the biopsy cervical
* Patient eligible for conization
* Patient must consent for the appropriate surgery
* Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1
* Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

* Pregnancy
* Previous conization
* limited comprehension of the study
* the risk of the American Society of Anesthesiologists, III or IV
* HIV or immunodepression
* Patients with a history of the invasive malignancies
Adjuvant Vitamin D With Corticosteroids in Active Crohn's Disease

The purpose of this study is to determine whether the addition of vitamin D to standard corticosteroids improves onset of remission in active Crohn's Disease, a form of Inflammatory Bowel Disease (IBD).

Crohn's Disease is a form of Inflammatory Bowel Disease (IBD). It is caused by abnormal immune-mediated gut inflammation and is both chronic and difficult to treat. Symptoms are often unpleasant (e.g. abdominal pain, diarrhoea, disfiguring fistulation) and often lead to surgery to remove diseased bowel.

There is emerging evidence that Vitamin D, a nutrient largely produced in the skin upon exposure to sun-light, may possess properties regulating the immune system in IBD. In addition, vitamin D deficiency appears common in Inflammatory Bowel Disease.

This study aims to determine if the addition of vitamin D to standard corticosteroid treatment in active Crohn's Disease helps to achieve remission (resolution of symptoms).

Eligibility Criteria:
Inclusion Criteria:

1. Active Crohn's Disease Activity (CDAI) Score \>200 to 450;
2. Diagnosis of IBD and distribution of disease previously confirmed
3. The participant able to give informed consent form;
4. Stable doses of the following concurrent IBD medications prior to inclusion:

   * 5-aminosalicylates (≥4 weeks)
   * Thiopurines (≥8 weeks)
   * No corticosteroids (within 4 weeks)
   * No biological agents (within 8 weeks).

Exclusion Criteria:

1. Unable to give informed written consent;
2. Co-existence of any other chronic inflammatory conditions
3. Failure to meet concurrent IBD medication criteria;
4. Hypercalcaemia (Corrected serum calcium \> 2.66 mmol/L) or history of vitamin D hypersensitivity;
5. Diagnosis of any of the flowing: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy, active TB, sarcoidosis or lymphoma or other granulomatous disease;
6. Known intolerance or contraindication to vitamin D or trial medication (i.e. corticosteroids / infliximab);
7. Biochemical disturbance at enrolment: serum corrected calcium \> 2.66 mmol/L) or serum creatinine \>250 micromol/L;
8. Pregnancy or breast-feeding.
Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a month under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).


Eligibility Criteria:
Inclusion Criteria:

* Ages eligible for study : 18 years to 74 years
* Genders eligible for study : Male and Female
* Diagnosed with T2DM
* Taking a stable dose of metformin monotherapy
* HbA1c levels of between ≥ 7.0% and ≤ 10.0%
* Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control
* Written informed consent must be obtained

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Diagnosis of type 1 diabetes mellitus
* Uncontrolled diabetes defined as a FPG level of \> 240 mg/dL at screening
* A significant change in body weight in the 3 months before screening
* Any history of GI intolerance
* Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
* Known history of acute or chronic pancreatitis
* A history of alcohol or drug abuse or drug addiction
Effect of Artificial Sweetener (AFS) on Glucose Metabolism in Patients with Type 1 Diabetes (T1D)

The goal of this randomized crossover study is to test the prediction that consuming carbohydrates will affect insulin release differently depending on whether Non-Nutritive Sweeteners (NNSs) are consumed simultaneously. We aim to determine whether the predicted effects are associated with oral or post-oral sweet taste receptor signaling,. Our study will focus on patients diagnosed with type 1 diabetes (T1D) who are using an artificial pancreas (AP) system, as it allows us to monitor glucose and insulin levels over time.

Participants will drink four different flavored beverages, some with sweet taste blockade and some without, in a counter-balanced order. They will then rate the sweetness of each beverage, and we will collect data from their AP system to monitor insulin and glucose level.

To achieve this, we will conduct a pilot study to assess the effectiveness and best timing of sweet taste blockade in healthy individuals. Insights gained from the pilot study will inform the main study.

Sucralose will be used as the NNS, maltodextrin as the carbohydrate, and Gymnema Sylvestre (GS) as the sweet taste receptor blocker.


Eligibility Criteria:
Inclusion Criteria:

* Participants with a diagnosis of T1D
* HbA1C ≤ 8 %
* Insulin pump therapy
* Adults of any gender or biological sex aged 18-45 years old,
* Body Mass Index (BMI) between 18.5-29.9 kg/m,
* Non-smokers,
* English or French speaker. ●. Who can consume chicken and fish

Exclusion Criteria:

* A major medical diagnosis that could potentially influence metabolic dysfunction
* A major medical diagnosis other than T1D,
* Alcohol or substance use disorder,
* Eating disorder or history of malabsorptive syndrome,
* Inflammatory bowel disease,
* Self-reported impairment in taste or smell,
* A known taste or smell dysfunction (e.g., anosmia),
* Active pregnancy and/or lactation,
* Food allergies or intolerances,
* Dislike of the test beverages,
* History of bariatric surgery at any point in the past ●. Regular consumer of Gymnema sylvestre
Emotion Regulation Group Therapy for Bipolar Disorder

Psychoeducation has been the only group treatment developed for bipolar disorder thus far. Deficits in emotion regulation, a core impairment among patients with bipolar disorder, are not directly addressed in this treatment. The objective of this study is to develop a group treatment for bipolar disorder that focuses on emotion regulation strategies (Enhancing Emotion Regulation; EER). This study will examine the efficacy of this treatment using an open trial design. It is hypothesized that patients who receive EER will show a reduction in mood symptoms and improvement in well-being. Reductions in emotion regulation difficulties will predict improvements.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of bipolar I disorder.
2. Able to provide written informed consent.
3. Men or women aged 18-65.
4. Able to read and understand English.
5. Psychiatrist prescribing mood-stabilizing medication.
6. Participates in bimonthly individual psychotherapy

Exclusion Criteria:

1. Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment.
2. History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc).
3. History or current diagnosis of the following Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, major depressive disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance dependence disorders, including alcohol, active within the last 12 months.
4. Patients who currently meet criteria for a major depressive episode, a manic episode, or a mixed episode. Excluded participants may remain on a waiting list to partake in a future group dependent on mood stabilization.
5. Patients who have had electroconvulsive therapy (ECT) within the 6 months preceding enrollment.