cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of TF002 in Cutaneous Mastocytosis

The current study will investigate the effects of TF002 on cutaneous mastocytosis or cutaneous involvement of systemic mastocytosis as compared to clobetasol proprionate (positive control) and a general skin care product without active ingredient targeting mastocytosis (negative control) based on clinical effects on Darier´s signs and the histological evaluation of mast cell numbers in skin bioptic material.

This is a randomised, double-blind, placebo- and active-controlled study with intra-individual comparison of test areas.

The primary study target is to evaluate the safety and efficacy of TF002 for the treatment of cutaneous mastocytosis or systemic mastocytosis with skin involvment. The treatment period of 14 days was adjusted to the maximum recommended treatment period for the comparator Dermoxinale®.

Since there are no approved therapies for this indication a placebo controlled design was chosen.

There are some reports about transient treatment effects using high potent steroids like clobetasol in mastocytosis. This triggered the decision to use Dermoxinale® as positive control.

To validate the clinical scores used in the study, surrogate markers describing the Darier´s sign (thermography, volumetric test) will be evaluated optionally.

Eligibility Criteria:
Inclusion Criteria:

* Chronic stable symptomatic maculopapulous cutaneous mastocytosis or systemic mastocytosis with involvement of the skin and with positive Darier's Sign
* 3 comparable skin lesional areas
* Otherwise healthy according to physical examination
* Informed consent signed and dated

Exclusion Criteria:

* Aggressive systemic mastocytosis
* Other dermatological diseases at treated skin site
* Known hypersensitivity to study drugs or their components
* Mental disorders
* Drug or alcohol dependency
* Any other chronic or acute illness requiring systemic treatment which might have any influence on the outcome of the study in the 4 weeks before start of treatment and during the study (investigator's decision).
* Immunodeficiency including HIV
* Pregnancy or lactation
* Participation in another clinical trial within the last 30 days
* Malignant skin lesions
* Radiation therapy of target areas excluding UV therapy longer then 4 weeks before start of study treatment
* Dermal comorbidities within the target areas
* Any concomitant medication which might influence the study objectives or are known to provoke or aggravate mastocytosis
A Phase 4 Study to Assess the Impact of Patient Support Program on Health Related Quality of Life and Adherence in Subjects With Relapsing-Remitting Multiple Sclerosis Administered Rebif® With the RebiSmart™ Device

This is a randomized, comparative, and multicenter study to assess the impact of a patient support program (MinSupport Plus) on health related quality of life (HRQoL) and adherence in subjects with relapsing-remitting multiple sclerosis administered Rebif® with the RebiSmart™ device.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18 or older
* A diagnosis of relapsing-remitting multiple sclerosis according to the revised McDonald Criteria (2010)
* Treatment with Rebif® 22 or 44 mcg subcutaneously three times a week in accordance to the Summary of product characteristics
* Rebif® administered by the RebiSmart™ device
* Provided a signed informed consent form

Exclusion Criteria:

* Has received any components, except for technical support, of MinSupport Plus prior to study entry
* Has difficulty reading and/or understanding Swedish
* Has a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
* No access to computer
* Participation in another clinical study
Incretin-mimetic Hypoglycemic Drugs and Severe Retinopathy

Experimental data suggest that GLP-1 promote endothelial cell growth and angiogenesis which may have beneficial effects on the cardiovascular system but harmful effects on the retina . This project investigate the possible link between incretin therapy and Severe Diabetic Retinopathy. The prevalence of severe DR in patients exposed to incretin therapy (GLP-1 analogs or DPP4 inhibitors) is compared to that in non-exposed patients to these antidiabetic classes.

This study is dedicated to investigate the impact of routinely prescribed hypoglycaemic treatments on the prevalence of severe retinopathy and to seek possible biomarkers of severe retinopathy. Hypoglycemic treatments taken by the patients are those prescribe by the usuel diabetogist in the context of routine care.

The study includes T2D patients according to ADA criteria treated with any kind of hypoglycemic treatment and attending a diabetes center (three in Marseille: Department of Endocrinology, Hôpital Nord, Assistance Publique des Hôpitaux de Marseille and Service d'Ophtalmologie, Hôpital Saint-Joseph and Service de Diabétologie, Hôpital Saint-Joseph, and two in Paris : Centre Universitaire du Diabète et de ses Complications Hôpital Lariboisière, Université Paris 7, Assistance Publique des Hôpitaux de Paris and Service d'Endocrinologie, Diabétologie et Nutrition, Hôpital Bichat).

It consists of two visits: Visits1 "Inclusion" and Visits 2 "three years after the inclusion". In each visit, the investigators will collect results of eye examination (fundus) and annual diabetes check up including anthropometric data, routine biology, diabetes complication status as well as medications taken by the patients (past and current). A bio-banking (blood, urine and hairs) will be also collected. Primary objective : to compare the prevalence of severe DR in patients exposed to incretin therapy (GLP-1 analogs or DPP4 inhibitors) to that in non-exposed patients at baseline.

Secondary objective: To compare the proportion of patients who worsen DR between V1 (inclusion) and V2 (after 3-yr of treatment) in patients exposed to incretin-based therapy from baseline vs non-exposed patients: patients with no DR or mild to moderate non proliferative DR at V1 who progress to severe DR at V2.

To evaluate whether the concentrations of angiogenic/inflammatory molecules and circulating endothelial and inflammatory cells are associated with severe DR in relation with the use of GLP-1 based therapy at V1 and V2.

Eligibility Criteria:
Inclusion Criteria:

* T2D patients according to ADA criteria treated with any kind of hypoglycaemic treatment
* Age above 18 years

Exclusion Criteria:

* Type 1 diabetes
* Patients with cataract preventing DR grading
* Patients who had panretinal photocoagulation more than 10 years ago
* Documented pregnancy or lactation
The Effect of Exercise on Fatigue in White-collar Workers

A survey will be conducted on the Internet for desk workers. The questionnaire; International Physical Activity Questionnaire will be filled out to evaluate the exercise level of the participants, the visual analog scale to question the general pain levels, and the fatigue severity questionnaire to investigate the fatigue levels. The patients will also be divided into the presence of osteoarthritis, the presence of fibromyalgia, and healthy group, and an evaluation will be made between the groups.

A survey will be conducted on the Internet for desk workers. The questionnaire; International Physical Activity Questionnaire will be filled out to evaluate the exercise level of the participants, the visual analog scale to question the general pain levels, and the fatigue severity questionnaire to investigate the fatigue levels. The patients will also be divided into the presence of osteoarthritis, the presence of fibromyalgia, and healthy group, and an evaluation will be made between the groups.

Eligibility Criteria:
Inclusion Criteria:

* 20-75 years old
* white-collar worker
* agree to participate in the study

Exclusion Criteria:

* history of musculoskeletal surgery
* the presence of illness that will prevent him/her from exercising
Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use

This study deploys a novel digital pill with Emtricitabine/Tenofovir (TDF/FTC) among MSM with substance use to monitor PrEP adherence. The investigators will enroll N=15 HIV uninfected MSM with self reported substance use who are on PrEP or initiating PrEP to use digital pills over encapsulating TDF/FTC for 3 months. The investigators will assess the feasibility of using digital pills in this study population as well as understand the acceptability of digital pills for adherence measurement using semi-structured individual interviews. Additionally, the investigators will measure adherence over time, as well as episodes of suboptimal PrEP adherence.

Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will complete a quantitative assessment on their history fo substance use, sexual risk and PrEP adherence, and be trained to use the digital pill for 90 days and instructed to take PrEP daily during the course of the study. Participants will return each month for a study visit to assess their use of the technology. At study visit 1 and 3, we will obtain dried blood spots (DBS) to measure drug levels and to confirm adherence detected by the digital pill. The investigators will also obtain drugs of abuse screens from DBS. At the final study visit (3 months), participants will undergo a semi-structured qualitative interview to understand the user response to digital pills.

Eligibility Criteria:
Inclusion Criteria:

1. MSM (cisgender male)
2. Self-reported use of non-alcohol substances of abuse in past 6 months
3. Currently taking PrEP
4. Has qualifying laboratory tests (Cr, hepatitis B immunization, STI testing and syphilis)
5. Age 18 or older

Exclusion Criteria:

1. Does not speak English
2. HIV positive
3. Identifies as transgender
4. Estimated creatinine clearance \<60ml/min
5. Active hepatitis B treatment
6. Does not own a smartphone
7. Taking proton pump inhibitors
8. History of Crohn's disease or ulcerative colitis
9. History of bowel surgery, gastric bypass, bowel stricture
10. History of GI malignancy or radiation to abdomen
11. Unable/unwilling to ingest digital pill
Metyrapone as Additive Treatment in Major Depression

The purpose of this study is to test whether metyrapone is an effective and safe augmenting agent in the treatment of major depression.

The investigators' understanding of the neuroendocrine pathophysiology of depression has made significant progress in recent years, which should help to develop new remedies. Alterations of the hypothalamic-pituitary-adrenocortical (HPA) axis are the most consistent pathological endocrine findings in depression. Hence, attempts have been made to treat depression by directly targeting HPA-axis activity. Currently, three major pathways are investigated:

* Administration of CRH-antagonists;
* Administration of glucocorticoid-receptor-antagonists; and
* Treatment with steroid-synthesis inhibitors like ketoconazole, aminogluthethimide or metyrapone.

The investigators' aim was to conduct the first prospective, randomized, placebo-controlled, double-blind clinical trial of metyrapone as additive treatment in depression. Metyrapone was preferred, since this compound inhibits selectively the 11β-hydroxylase and the 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD-1), thereby exerting direct effects within the central nervous system (CNS). The additive approach was applied because the intended inclusion of severely depressed patients made a pure placebo group ethically challenging. Furthermore, the continuous use of an antidepressant allowed a standardized follow up after the double-blind period.

The hypotheses to be tested were, whether metyrapone exerts potentiating effects during a standard antidepressant therapy and whether an earlier onset-of-action and an improved overall and sustained treatment response can be achieved. Since GR/MR distribution as well as 11β-HSD-1 activities are subject to sexual dimorphism in humans, the sample was prospectively stratified for gender and balanced for treatment with two selected serotonergic antidepressants, allowing further analysis of gender effects and neuroendocrine treatment effects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder; single or recurrent according to DSM-IV criteria (296.2 or 296.3)
* A minimum baseline Hamilton score of 18 points on the Hamilton Rating Scale for Depression (HamD; 21-item version)
* Age from 18 to 75 years
* A drug free period of at least 5 days from antidepressants, antipsychotics, mood stabilizers and all other medications except for mild antihypertensive agents
* A negative urinary drug screening diagnosis

Exclusion Criteria:

* A current DSM-IV diagnosis for other axis I psychiatric disorders
* Serious medical conditions, especially those associated with adrenal insufficiency
* Pregnancy, nursing or refusal to use a reliable method of birth control in women.

Participants were randomly assigned to a study group if they met these criteria.
XL119 Versus 5-Fluorouracil (5-FU) Plus Leucovorin (LV) in Subjects With Advanced Biliary Tumors

The main purpose of this study is to determine if XL119 is more effective than the combination of 5-fluorouracil (5FU) and leucovorin (LV) in prolonging the survival of subjects with advanced biliary tumors.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects with advanced histologically confirmed biliary cancer (gallbladder cancer or cholangiocarcinoma) that is not amenable to conventional surgical approach
* 18 years or older
* Life expectancy of at least 12 weeks
* Eastern Cooperative Oncology Group (ECOG) Performance Status score less than 3
* Willing and able to sign informed consent
* Sexually active men and women must use an accepted and effective method of contraception (including barrier contraception with spermicide)
* Women of child-bearing age must have a negative pregnancy test
* Laboratory criteria

Exclusion Criteria:

* Prior chemotherapy (excluding chemotherapy given as adjuvant treatment completing more than 6 months prior to entry into study)
* Unstable angina, or class III or IV New York Heart Association heart disease
* Central nervous system metastases
* Uncontrolled diabetes mellitus
* Uncontrolled seizure disorder
* Major surgery, chemotherapy, immunotherapy, or radiotherapy during the 28 days preceding the first study treatment
* Need for concomitant anticancer therapy (chemotherapy, immunotherapy, or radiation) or other investigational agents during study participation or 28 days prior to study participation
* Pregnant or breast-feeding
* A known history of human immunodeficiency virus (HIV) infection
Effect of Genotyping for CYP450 Polymorphisms Versus Intense Clinical Monitoring on Antipsychotic Drug Treatment

The purpose of this study is to determine whether genotyping for CYP2D6 and 2C19 polymorphisms or intense clinical monitoring of treatment and adverse effects improves the antipsychotic treatment in patients with schizophrenia. This study is designed as a three-armed prospective randomized controlled clinical trial and includes 300 patients with schizophrenia. Patients are followed for a period of one year.

During the study period the following effect measures are registered:

* Time to discontinuation of all antipsychotic medications
* Number of changes in medication dose
* Number of changes in medication
* Compliance (patients´ adherence to medical treatment)
* Clinical symptoms
* Adverse effects


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with schizophrenia
* Able to give written informed consent

Exclusion Criteria:

* Genotyped prior to inclusion
Light Emitting Diode for theTreatment of Genitourinary Syndrome of Menopause Associated With Breast Cancer Treatment

Breast Cancer treatment may cause several side effects, some long lasting. Adjuvant hormone therapy helps avoiding recurrence triggers vulvovaginal atrophy syndrome. This study evaluate a photodynamic treatment with light emitting diode to improve vaginal dryness and irritation, pruritus, pain or discomfort in intercourse.

The Genitourinary Menopause Syndrome (MMS) affects up to 70% of in treatment breast cancer patients. Symptoms are due to a decrease in hormone levels or block to circulating hormones and induce functional changes in the vagina cutting in quality of life and impacting sexual function.

This is a randomized, double blind trial in a sample of 74 individuals that will be performed at an specialized Pelvic Floor Care Center (CAAP) in Brazil. Will be included women age between 18 and 65 years, in adjuvant hormone therapy, with clinical signs and symptoms of vulvovaginal atrophy syndrome and cytologic evidence of atrophy, (pH \<5.0 and vaginal cytology with predominance of superficial cells).

Will be excluded from the study the patients in hormonal replacement for less than 6 months, diagnosis of vaginal infection, pregnant women, difficulty understanding the proposed instruments and patients with chronic neurological degenerative diseases.

Three 405 nm light emitting diode (LED) sessions will be performed, with a seven days interval between them compared with sham procedure, and both groups will perform five sessions of kinesiotherapy sessions.

Maturation vaginal index will be checked before and after all treatment and self- administered questionnaires will be performed before each session with Female Sexual Function Index (FSFI) - Female Version (QS-F), Female Genital Self-Image Scale - 7 (FGSIS-7), International Consultation on Incontinence Questionnaire - Short Form, (ICIQ-SF), Functional Assessment Of Cancer Therapy - Breast Cancer (FACT-B).

At the end of treatment, the visual analog scale and Likert scale will be used to measure the individual's satisfaction

Eligibility Criteria:
Inclusion Criteria:

* 18-65 anos
* Pathological proven Breast Cancer diagnosis
* Stage 0-III by American Joint Committee on Cancer (AJCC) and International Union Against Cancer (UICC) of Classification of Malignant Tumours, TNM (Acronym for Tumor-Node-Metastasis) 8ª edition
* Genitourinary Syndrome of Menopause confirmed through patient-reported symptoms and gynecological examination (of external structures, introitus, and vaginal mucosa)
* Vaginal pH \>5,0

Exclusion Criteria:

* Hormone replacement less than 6 months
* Diagnosis of vaginal infection
* Difficulty in understanding the proposed instruments
* Patients with chronic neurological degenerative diseases that preclude to be on position
* Metastatic disease
* Any vaginal photodynamic treatment less than 3 months
Additional 6-Month Safety Follow-up After Completion of Precursor Study 880801

The purpose of this study is to verify the long-term safety of a 2.5 µg, adjuvanted (aluminium hydroxide) dose of Ross River Virus (RRV) vaccine.


Eligibility Criteria:
Inclusion Criteria:

Subjects who participated in precursor Study 880801 and meet all of the following criteria:

* Subject received 3 RRV vaccinations in Study 880801
* Subject has completed Visit 6 in Study 880801
* Subject and, if applicable, subject´s parent(s)/legal guardian(s), understand the nature of the study and its procedures, agree to its provisions and provide written informed consent prior to study entry
* Subject provides written assent according to his/her age, if applicable

Exclusion Criteria:

* Subject has participated in another clinical study other than Study 880801 involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Acute, Affective, Organic Disorders.

The purpose of the study is to investigate whether patients with brief depressive periods together with other fluctuating psychiatric symptoms, have this condition due to epilepsy or an other organic brain disorder.

A limited number of patients admitted to psychiatric acute wards or Psychiatric Intensive Care Units are admitted with a fluctuating array of psychiatric symptoms including brief depressive episodes. These patients do not fit into the present diagnostic systems due to short duration of affective symptoms and the fluctuating arrays of other symptoms. Case histories indicate that these patients have psychiatric conditions due to epilepsy or organic brain dysfunctions.

In the study acutely admitted patients filling criteria for two recent DSM-4 axis 1 diagnoses (one is a brief depressive period) during the last two weeks are compared to age- and sex-matched patients acutely admitted with a major depressive disorder. The patients are rated with a number of rating scales at admittance, day 5, after two weeks and three months. EEG and QEEG are taken three times the first week. MRI, drug screening and blood screening of medication-concentrations are taken.

Eligibility Criteria:
Inclusion Criteria:

* Acutely admitted psychiatric patients who have at different times the last 2 weeks filled criteria for at least two new DSM-4 Axis 1 psychiatric diagnoses. One of them has to be a depressive episode (MADRS\>20)

Exclusion Criteria:

* Patients not speaking Norwegian or English.
* Patients not willing to participate.
* Patients with dementia or mental retardation to an extensive degree.
Examining Community-based Effectiveness of a Substance Use and HIV Risk Reduction Intervention for Young Men of Color

This study will conduct an effectiveness trial of the 4-session evidence-based YMHP intervention for young men who have sex with men (YMSM) of color ages 15-29 at two CBOs in New York City, compared to usual care.

We will conduct a comparative effectiveness trial (CET) with two intensities of treatment to be offered following field-based HIV counseling and testing (C\&T) - the young men's health project (YMHP) intervention and an enhanced "treatment as usual" (eTAU) condition involving HIV prevention services provided at two community based organizations (CBOs) to test their relative effectiveness in reducing substance use and sexual risk behavior among HIV-negative YMSM. In collaboration with two CBOs, our goals are to better understand substance use and sexual health-related outcomes among HIV-negative YMSM who are unlikely to be treatment seeking and to implement the YMHP intervention in a way that will maximize portability and scalability. Working together with our collaborators will help to address practical problems at the frontline of service provision to pave the way for a comprehensive program to reduce substance use and HIV infection among YMSM.

Eligibility Criteria:
Inclusion Criteria:

* HIV-negative test result from the past 90 days
* 15-29 years of age
* Born biologically male or currently identifying as male
* Sex with men in the past 90 days
* ≥ 5 days of illicit drug use in the past 90 days
* ≥ 1 episode of condomless anal sex (CAS) in the past 90 days, or a positive sexually transmitted infection test result in the past 90 days.
* Living in the New York City area
* Able to communicate in English

Exclusion Criteria:

* Serious cognitive or psychiatric impairments
* ≥5 days of injection drug use in the past 90 days
* Currently taking Truvada as Pre-Exposure Prophylaxis (PrEP)