cyrilzakka/clinical-trials huggingface dataset:
BPA Biomonitoring Study in Cashiers

We intend to conduct a pilot study designed to measure BPA levels before and after occupational exposure to thermal paper used in cash registers. We will recruit cashiers from a local commercial store that is currently still using BPA-laden thermal paper and plans to switch to BPA-free paper in the near future. The study uses a within-subject comparison design, using serum and urine samples to determine whether BPA is detectable in the study population at sufficient levels to measure differences in paired samples. Two phases of sample collection are proposed: Phase I - collecting paired samples on two separate occasions before the implementation of BPA-free thermal paper use in cash registers; and Phase II - collecting paired samples on two separate occasions after the implementation of this change in thermal paper.

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We intend to conduct a pilot study designed to measure BPA levels before and after occupational exposure to thermal paper used in cash registers. We will recruit cashiers from a local commercial store that is currently still using BPA-laden thermal paper and plans to switch to BPA-free paper in the near future. The study uses a within-subject comparison design, using serum and urine samples to determine whether BPA is detectable in the study population at sufficient levels to measure differences in paired samples. Two phases of sample collection are proposed: Phase I - collecting paired samples on two separate occasions before the implementation of BPA-free thermal paper use in cash registers; and Phase II - collecting paired samples on two separate occasions after the implementation of this change in thermal paper.

Eligibility Criteria:
* INCLUSION CRITERIA:
* Male or female 18 years of age or older at the time of enrollment
* Employed as a cashier at the site location
* Anticipate continued employment at this business for the duration of both phases of the study
* Able to understand and provide written informed consent to participate in the study
* Have a minimum of 24 hours off from work before providing pre-shift samples
* Participants may be healthy or have preexisting conditions.

Field Site Inclusion Criteria:

* Have a minimum of 20 employed cashiers
* Use BPA-laden thermal paper and is planning to switch to BPA-free thermal paper
* Have a private area that the study nurse can use for enrollment and collection of biological samples
* Willing to collaborate with study team to conduct study on-site

EXCLUSION CRITERIA:

-There are no additional exclusion criteria
Antimicrobial Resistant Organism Decolonization After Microbiome Perturbation

ARO-DECAMP is a multi-centre, placebo-controlled, pilot and feasibility randomized controlled trial for the microbial consortium Microbial Ecosystem Therapeutic-2. Non-intensive care unit patients ≥ 18 years old diagnosed with a bloodstream infection and receiving treatment for an antibiotic resistant organism will be included. Participants will be randomized to receive either MET-2 or placebo for 10 days. Recruitment rate and study intervention adherence will be evaluated for feasibility. Participants will be followed for 180 days, and biological samples will be collected periodically for clinical, ecological, and biomarker outcomes.

Reconstituting the perturbed microbiome is a novel therapeutic modality with the potential to decrease ARO colonization and infection and combat AMR without additional pressure for selection of further antimicrobial resistance. No trial has yet assessed the potential of a therapeutic microbial consortium for ARO decolonization and infection prevention after antibiotic treatment.

The investigational product, Microbial Ecosystem Therapeutic-2 (MET-2), is a defined microbial community derived from healthy donor stool. MET capsules are orally administered mixtures of bacterial strains cultured from the stool of a healthy donor. This study is designed to determine if a trial of administration of MET-2 after antibiotic treatment for bloodstream infections is feasible. Stool and plasma biomarkers to assess the effects of the intervention will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥18 years old) inpatient not admitted to the ICU or equivalent (step-up and step-down units are eligible)
2. Positive blood culture with an ARO:

   * AmpC beta-lactamase producing species: Enterobacter cloacae, Citrobacter spp., Klebsiella aerogenes, Serratia spp., Morganella morganii, Hafnia alvei OR
   * ESBL-producing gram-negative bacilli
3. Currently receiving treatment for the bloodstream infection

Exclusion Criteria:

1. Inability to swallow oral MET-2 or placebo capsule
2. Recipient of small bowel transplant
3. Inflammatory bowel disease, short bowel syndrome, diverting/non-diverting ileo/colostomy
4. Use of \>3 days over-the-counter or prescription probiotics (not including food additives) within 10 days of enrolment
5. Receipt of fecal microbiota transplant (FMT) within 3 months of enrolment
6. Absolute neutrophil count \<0.5x109/L
7. Death expected within 72 hours of enrolment
8. Planned continuation of non-prophylaxis antimicrobial therapy active against the bloodstream isolate for \>42 days
9. Known pregnancy, planning to become pregnant during the study period, or breastfeeding
10. Any other reason in view of the site investigator or treating team
SELVA: A Phase 3 Study Evaluating QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

SELVA: A Multicenter, Phase 3 Baseline-Controlled Study Evaluating the Safety and Efficacy of QTORIN 3.9% Rapamycin Anhydrous Gel in the Treatment of Microcystic Lymphatic Malformations

The main purpose of this study is to assess the change in microcystic lymphatic malformations IGA after 24 weeks of treatment with QTORIN 3.9% Rapamycin Anhydrous Gel in approximately 40 participants with microcystic lymphatic malformations. Efficacy will be evaluated at 24 weeks and patients have the option of continuing on treatment for \>24 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant must be at least 6 years of age at time of consent
* Participant must have a clinically confirmed superficial/cutaneous microcystic lymphatic malformation

Key Exclusion Criteria:

* Participants who have vascular malformations that interfere with evaluating the target microcystic lymphatic malformation
* Participants with complicated vascular anomalies with severe systemic symptoms that require systemic therapy
* The participant's treatment area is mainly in any wet mucosa or within the orbital rim
* Participants who are pregnant or planning to become pregnant
Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis

To study the efficacy and safety of combination of Ro-Peg-interferon-α2b (RoPegIFN) with Bosutinib (BOS) in comparison to BOS monotherapy, as frontline therapy for newly diagnosed chronic myeloid leukemia patients, and to estimate efficacy of the addition of RoPegIFN to BOS in terms of deep molecular response with the aim of increasing the proportion of patients who may achieve treatment free remission. (NCMLSG study #NordCML012)


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent form (ICF) before any procedure related to the study
* Newly diagnosed (≤ 3 months) BCR-ABL positive chronic myeloid leukemia (CML) in chronic phase
* Major BCR-ABL transcripts (p210 b2a2(e13a2) and/or b3a2 (e14a2)
* Not previously treated for CML except with hydroxyurea or anagrelide
* ECOG Performance Status (ECOG PS) ≤ 2
* Adequate organ function: Total bilirubin \< 1,5 times the institutional Upper Limit of Normal (ULN); Hepatic enzymes ASAT and ALAT \< 2 times the institutional ULN; Serum Creatinine \< 1.5 time the institutional ULN; Lipase \< 1.5 time the institutional ULN
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
* WOCBP must have a negative serum or urine pregnancy test at screening.
* Free subject, without guardianship nor subordination
* Health insurance coverage

Exclusion Criteria:

* Patients with BCR-ABL transcript other than M-BCR-ABL
* Patients previously treated with tyrosine kinase inhibitors (TKIs).
* Inability to freely provide consent through judiciary or administrative condition.
* Ongoing participation to another clinical investigational study.
* Medical history and concurrent diseases: a) Hypersensitivity to any of the excipients of BOS or RoPegIFN, b) Prior treatment with Interferon-α, contraindication to interferon-α, c) Autoimmune disorder, concomitant immunosuppressive treatment or corticosteroids, d) Pre-existing thyroid disease unless controlled with conventional treatment, auto-immune thyroiditis, e) Chronic liver disease, f) Prior or ongoing severe psychiatric disease, g) HIV positivity, chronic hepatitis B or C, h) Uncontrolled or severe cardiac (NYHA Class III or IV) or pulmonary disease, echocardiography with LVF \< 45% or LLN, peak velocity of tricuspid regurgitant flow \> 2,8 m/s, pulmonary arterial hypertension (PAH), QTc\>450 ms (by Barrets correction)
* Other malignant disease during the last 5 years prior to the inclusion except non-melanoma skin carcinoma or carcinoma in situ of the cervix,
* History of significant bleeding disorder unrelated to CML or diagnosed congenital bleeding disorder,
* Subjects with an uncontrolled undercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the subject or compliance with the protocol.
* Prohibited treatments and/or therapies: strong inhibitors/inducers of the CYP 3A4,
* History / any condition for poor compliance to medical treatment.
* Women who are pregnant or breastfeeding are not eligible for this study
A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis

Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults.


Eligibility Criteria:
Main Inclusion Criteria:

* Good general health
* Phototype I to IV
* Mild to moderate SCORAD (between 15 and 25)

Main Exclusion Criteria:

* Pregnant/breastfeeding female or who have planned a pregnancy during the study period
* Positive history for atopy or hypersensitive skin
* Subjects under systemically pharmacological treatment
* Subjects under locally pharmacological treatment on the skin area monitored during the test
* Subjects with congenital or acquired immunodeficiency
* Subjects under treatment with food supplements which could interfere with the functionality of the product under study
* Subjects which show other skin alterations on the monitored area except for acne lesions
* Subjects with known or suspected sensitization to one or more test formulation ingredients
TEAM (Thiotepa, Etoposide, Cytosar, Melphalan ) for AutoSCT in Lymphoma

Study is designed to explore whether the introduction of Thiotepa, to the pre autologous stem-cell transplantation (ASCT) conditioning will reduce toxicity and thus improve outcome following transplantation in up to 24 patients with malignant lymphoma including both non-Hodgkin's lymphoma (NHL) and Hodgkin's lymphoma ( HL) improving toxicity profile , reducing side effects while potentially improving the antitumor response. Specifically,we speculate that using the novel Thiotepa based TEAM consisted of THIOTEPA 5mg/kg on days -7-6, etoposide 200 mg/m2 , Cytosar (ARA-C) 200 mg/m2 on days -5,-4, -3, -2 and melphalan 140 mg/m2 on day -1, pre transplantation conditioning regimen may allow transplantation with lower transplant related toxicity and thus improve outcome in this setting. Toward this aim the impact on toxicity profile ,engraftment and disease control will be assessed.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with non-Hodgkin's and Hodgkin's lymphoma as confirmed by a pathological biopsy report.
2. Patients who are candidates for Autologous stem-cell transplantation due to refractory or relapsing disease by standard institutional indications and comply with standard transplant eligibility criteria.
3. Age less than physiologic 70 years.
4. Patients with an adequate autologous stem cell collection for transplantation and backup (\>5 x 106 CD34(cluster of differentiation 34)+ cells/kg) .Patients must sign written informed consent.
5. No limitation on bulky disease or bone marrow involvement. No limitation on the number and response to prior therapy. Prior autologous transplantation and/or treatment with rituximab allowed. All prior chemotherapy completed at least three weeks before study treatment

Exclusion Criteria:

1. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
2. Creatinine \> 2.0 mg/dl
3. Eastern Cooperative Oncology Group (ECOG) Performance status \> 2
4. Uncontrolled infection
5. Pregnancy or lactation
6. Abnormal lung diffusion capacity (DLCO \< 40% predicted)
7. Severe cardiovascular disease
8. CNS (central nervous system) disease involvement
9. Pleural effusion or ascites \> 1 liter
10. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
Reduction of Drug Use and HIV Risk Among Out-of-Treatment Methamphetamine Users

There is a need to identify and test effective strategies to reduce meth use and human immunodeficiency virus (HIV) risk behaviors in heterosexuals. This project will compare the efficacy of a manually-driven HIV testing and counseling (HIV T/C) intervention, with HIV T/C plus a manualized Contingency Management (CM), with HIV T/C plus CM plus a manualized Strengths-Based Case Management (CM/SBCM) model. As HIV T/C is the standard of care, the investigators are testing to determine if the investigators can enhance this standard. The specific aims and hypotheses of this protocol are:

1. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing drug use, specifically meth use. Hypothesis 1: CM/SBCM will reduce drug use more than those in CM (which will have more reduction than HIV T/C), potentially mediated through increased service utilization.
2. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on reducing HIV and STI risk behaviors, specifically sex risk behaviors but also needle risk for injection drug users (IDUs). Hypothesis 2: CM/SBCM will have greater decreases in HIV risk behaviors than those in CM (which will have greater decreases than HIV T/C), potentially mediated through reduced drug use.
3. To compare the relative efficacy of HIV T/C vs. CM vs. CM/SBCM on improving mental health status. Hypothesis 3: CM/SBCM will have greater improvements in mental health status than those in CM (which will have greater improvements than HIV T/C), potentially mediated through increased service utilization and reduction of drug use, and potentially moderated by baseline meth use.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Be competent (not too intoxicated or mentally disabled) to give informed consent at the time of the interview
* Meth use (verified through urine drug screening and a self-report of meth use of at least 4 times per month for the last 3 months)
* Self-reported sex with someone of the opposite sex in last 30 days
* Ability to provide a reliable address and phone number for contact
* Not in drug treatment in the past 30 days
* Willingness to be tested for HIV at baseline and follow-up
* Not transient and no know reason why he/she will not be available for follow-up interviews
* Not currently mandated by the criminal justice system to receive treatment based on self-report.

Exclusion Criteria:

* Participation in drug treatment in the past 30 days
* Currently participating in another Project Safe study
* Pregnant or attempting to become pregnant
* Intoxicated or impaired mentally to the point that they cannot voluntarily consent to participate tin the project and/or respond to the interview
Early-stage Ovarian Clear Cell Carcinoma (OCCC) Patients at Risk of Recurrence

The goal of this observational study is to determine the risk of recurrence in early-stage OCCC (Ovarian Clear Cell Carcinoma) patients who received postoperative adjuvant treatment.

Participants were received platinum-based adjuvant therapy following debulking surgery will be included for the study.

This is a retrospective, global multicenter, single-arm, study for early-stage OCCC (Ovarian Clear Cell Carcinoma) patients at risk of recurrence following the first-line treatment. This study is planned to enroll 272 patients eligible for participation from two study sites in Taiwan, one in Korea, and one in Japan. The study will use archival Formalin-Fixed Paraffin-Embedded (FFPE) samples from patients who have received adjuvant therapy following debulking surgery. The study is designed to identify OCCC patients at risk for relapse and apply clinical stratification by IHC staining of 3 selected markers (CD45, CD8, tryptase) to prepare as clinical assays.

Eligibility Criteria:
Inclusion Criteria:

* Women aged ≥20 years old.
* Participant with histologically confirmed OCCC of stage IC2, IC3, IIA and IIB by International Federation of Gynecology and Obstetrics (FIGO) 2014 system.
* Participant has received platinum-based regimens for 3 to 6 cycles combined with paclitaxel, gemcitabine, cyclophosphamide, or bevacizumab adjuvant therapy following debulking surgery.
* Formalin-fixed paraffin-embedded (FFPE) tissue samples available.

Exclusion Criteria:

* Absence of histological confirmation of the diagnosis.
* Unusable sample or biologically deteriorated.
Bacteremia in Periodontal Patients

Bacteremia represents the presence of live germs in the blood stream. Patients with gum disease show damaged tissues and seem to be more susceptible to bacteremia. In fact, daily activities such as mastication can induce bacteremia in these patients. Dental procedures related to bleeding also induce bacteremia. However, there are many questions that should be clarified. Among them, clinical strategies that are able to reduce the levels of germs in blood should be determined. This desirable effect could be particularly important for some patients, for example, for those at higher risk for endocarditis. Therefore, this study tested if 0.12% chlorhexidine solution used as a single mouth rinse before dental instrumentation could reduce the levels of bacteria in the blood. In addition, the occurrence and magnitude of bacteremia in patients with gum disease were investigated by two different laboratorial techniques. After receiving verbal and written explanations and after signed the informed consent form, 80 systemically healthy volunteers diagnosed with gum disease having dental plaque and tartar were randomly allocated in one the following groups: a) mouth-rinse use and dental instrumentation and b) dental instrumentation with no mouth rinse. In a preliminary visit volunteers underwent a complete periodontal examination which included clinical measurements (inflammatory and debris accumulation indicators), microbial (tongue and dental plaque samples collected with paper points), saliva (to determine volume and biological indicators) and gingival crevicular fluid sampling (to monitor gingival inflammation profile). In the next visit, dental instrumentation was performed under local anesthesia, after the mouth rinse single use in the most diseased periodontal teeth/quadrant. Blood samples were collected before any dental procedure, 2 and 6 minutes after dental instrumentation. Oral hygiene instructions and periodontal treatment were performed in additional visits according to individual needs. Finally, the relation between bacteremia and several indicators of periodontal status was investigated.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate plaque related gingivitis (gingivitis group)
* mild to moderate periodontitis (periodontitis group)
* at least 20 natural teeth
* with no recognized systemic risk related to bacteremia
* no need for antibiotic prophylaxis before dental procedures

Exclusion Criteria:

* systemic diseases or other conditions that could influence the periodontal status;
* alcohol or other drugs abuse;
* orthodontic devices;
* extended prosthetic fixed devices, removable partial dentures or overhanging restorations;
* pregnancy or breast-feeding;
* history of sensitivity or suspected allergies following the use of chlorhexidine;
* antibiotics and/or anti-inflammatory drug use in the three months prior to the beginning of the study;
* regular use of chemotherapeutic antiplaque/antigingivitis products;
* any furcation lesions;
* periodontal treatment performed within six months prior to study initiation;
* unwillingness to return for follow-up.
Investigation of the Psychosocial Factors Responsible for the Late Recourse to HIV Testing Within MSM

The present study will try to investigate and analyze the psycho-social hindrances and levers concerning the recourse to late HIV testing among the MSM population.

This study is divided in two parts. The first one will consist of individual and groups interviews. Then, depending on the items that will rise from the first part of the study, groups interview will take place based on theses items. Finally, a questionnaire build from the collected information will be sent to MSM community in order to obtain quantitative results.

The late recourse to HIV testing, among the population in general way and among MSM population in a more specific way, participates in the dissemination of the HIV epidemic. Actually, there is no cure for HIV infection, but treatments that reduce viral charge to undetectable level exists. When diagnosed and treated earlier, seropositive people will be less communicating the virus because of the reduction of their viral charge.

This study aims to uncover the reasons behind the late recourse to HIV testing in MSM population facing a high risk of contamination.

The study hypothesis, is that late recourse to HIV testing is probably related to social and economics factors like age, social standing, accessibility to the diagnosis or even to a traditional beliefs or a fear of stigma etc. To shed the light on these factors, the main objectives of the investigator will try to investigate and analyze the psycho-social hindrances and levers through a quantitative and qualitative approach. This plurality of approaches is a part of a methodological triangulation method described by Kalampalikis \& Apostolidis, 2016.

People among MSM community having had a late or very late HIV test (as defined by biological parameters :CD4≤200/mm3 or having been diagnosed with AIDS), will be recruited in this study. During the first phase of the study, the eligible population will participate to individual or group interview . This qualitative part of the project will allow the set up of a questionnaire that will be diffused widely to the MSM community to have quantitative results.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive
* Self-reported homo-or bisexual contamination mode
* TCD4 + / mm3 200 200 lymphocyte count or Have an AIDS classifying event
* Diagnosis of HIV positive for at least two months and for a maximum of 24 months

Exclusion Criteria:

* Primary infection