cyrilzakka/clinical-trials huggingface dataset:
Disease Activity Biomarkers in Patients With Systemic Lupus Erythematosus

The aim of this research project is to better understand the origin and clinical significance of two lupus-specific "genetic signatures" (IFN signature and plasma cell signature) in patient subgroups with well-defined clinical characteristics. Our aim is to correlate these genetic signatures with cell activation profiles and the production of specific cytokines in different populations from whole blood and in short-term cultures of these circulating cells.

The aim of the experiment is, on the one hand, to identify and study the different cell populations from whole blood by flow cytometry and, on the other hand, to assay different cytokines in blood and urine samples from diseased (SLE) and control subjects (with non-inflammatory rheumatic diseases) in order to highlight and correlate the presence of biomarkers to disease activity or to a clinical manifestation of the disease.

In vitro studies will also be carried out on short-term cultures of PBMCs (Peripheral Blood Mononuclear Cells).

Eligibility Criteria:
Inclusion Criteria:

* Fulfilment of the EULAR/ACR classification criteria of SLE.
* 18 years of age or above.
* Incident or Flare biopsy-proven proliferative or membranous LN

Exclusion Criteria:

* Antiphospholipid syndrome nephropathy (APSN).
* Pregnancy at baseline (pregnancy during follow-up will not lead to exclusion).
* Anticipated non-adherence to therapy.
* Medical conditions interfering with outcome evaluations.
* Inability to read and/or sign the informed consent form.
A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of first line treatments for BRAF-mutant mCRC patients. In the absence of targeted/specific treatment for BRAF-mutant mCRC, treatment practices can vary based on local practices and guidelines. There is, therefore, an unmet need to document the current practices for first-line treatment of BRAF-mutant mCRC, and their effectiveness and safety in a real-world setting.

This real-world, multicenter non-interventional study (NIS) will describe the treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in Europe, with the aim to put the clinical study findings of the ongoing Phase 2, single-arm, open label trial (ANCHOR) into context of the current treatment landscape excluding investigational therapies. Additionally, the NIS output may be used to support future health technology assessment submissions and publications.

This retrospective, multi-center longitudinal study on BRAFV600E mutant mCRC patients will be conducted in Europe to characterize the first-line treatment patterns. All BRAFV600E mutant patients having initiated a first-line treatment for mCRC between January 1st, 2016 and December 31st, 2018 (both days inclusive) with drugs registered for mCRC in respective country will be eligible to participate. The study will not provide or recommend any treatment or procedure; all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices and all eligible patients will be considered for enrollment.

The target countries for patient enrollment will include Germany, France, Italy, United Kingdom, Spain, Belgium, Austria and the Netherlands. Approximately 300 adult patients (≥18 years) from a mix of academic and non-academic sites (up to 65 sites) will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically or cytologically confirmed CRC that is metastatic and unresectable
* Presence of BRAFV600E mutation in tumor tissue, as confirmed by a local assay
* Initiated first-line treatment with drugs registered for mCRC in the respective country at the time of treatment between January 1st, 2016 and December 31st, 2018 (both days inclusive)
* Provision of informed consent or non-opposition to the patient (or next of kin, if applicable) for the use of data, according to local regulations

Exclusion Criteria:

Patients will be excluded from the study if they fulfil any of the following criteria:

* Patients with another concomitant cancer at the time of diagnosis\*
* Patients participating in interventional trials on investigational drugs at the time of initiation of first-line treatment

  * Except for non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of mCRC diagnosis.
The Effect of Meal Composition on Blood Lipids

The purpose of this study is to see if a high-protein meal leads to a better postprandial (after a meal) blood lipid profile compared to a high-monounsaturated meal.

The effect of a high-protein diet compared to a high-monounsaturated fat diet on fasting lipids is controversial (1,2), In addition, these studies did not examine the effect of a high-protein compared to a high-monounsaturated meal on postprandial lipid concentrations. Postprandial lipid responses are important to examine since they are associated with heart disease (3,4). In addition, most individuals in Western countries are in a postprandial state for majority of the day. The present study will compare the effect of a high-protein meal versus a high-monounsaturated fat meal on postprandial lipid responses.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-65 years.

Exclusion Criteria:

* Use of medications or supplements that affect lipid levels, body weight, or blood glucose,
* following a weight loss diet,
* being a vegan,
* smoking,
* heavy alcohol use,
* pregnancy,
* lactation,
* severe depression,
* eating disorders,
* presence of liver, kidney, gastrointestinal, adrenal, or untreated thyroid disease,
* diabetes,
* lactose intolerance,
* documented mal-absorption, or
* bowel surgery that affects absorption.
The Feasibility of a Prehabilitation Program in the Liver Transplant Population at Barnes-Jewish Hospital

The primary outcome of this study is to demonstrate the feasibility of a prehabilitation program at Barnes Jewish Hospital for liver transplant candidates. Those patients who consent to participate in the study and are placed on the transplant list will be randomized into either the control or intervention group. The intervention group receives a personalized home exercise program along with weekly phone calls to provide coaching, mentoring and motivation. Data collected at baseline, post-transplant and, post-transplant follow up will be compared among the two study groups. The secondary outcomes include: normative data of functional measures for patients with end stage liver disease and to determine the effect size for future research on prehabilitation in the patient population.


Eligibility Criteria:
Inclusion Criteria:

* Being evaluated for liver transplantation by Barnes Jewish Hospital medical team

Exclusion Criteria:

* Non-english speaking
* Medical contraindications to exercise as determined by the medical team
Web-Based Training for EAP Alcohol Screening, Brief Intervention, and Refer

The goal of the proposed research is to complete the development of a web-based program to train Employee Assistance Program (EAP) and EAP-affiliated managed behavioral health organization (MBHO) practitioners to conduct screening, brief intervention, and referral to treatment (SBIRT) for problem alcohol use among working adults.

In Phase 2, the investigators propose to develop the SBIRT Training \& Support Tool with two components: (1) online SBIRT Training for call-center and face-to-face practitioners conducting alcohol SBIRT and (2) SBIRT Support Tool with mobile/web interactive alcohol screening tools and brief intervention protocols to facilitate use of SBIRT by practitioners. The SBIRT Training component will provide practitioners with the skills, knowledge, motivation, and self-efficacy to: (a) screen their clients for unhealthy alcohol use with validated screening tools; (b) provide brief, motivational interviewing-informed intervention; and (c) make appropriate referrals. The training program will incorporate the Phase 1 content and expand the curriculum to include the use of additional validated alcohol screening tools. Content for alcohol SBIRT will be derived from NIAAA evidence-based materials.

The SBIRT Support Tool will provide a mobile/web interface for practitioners to use interactive screening and brief intervention forms with (a) prompts for validated questions in the screening or brief intervention; (b) motivational interviewing-informed dialogue suggestions; (c) online resources (i.e., standard drink list; importance, confidence rulers); and (d) alcohol education and referral information. The practitioner will use the SBIRT Support Tool to (a) screen clients for alcohol use with interactive validated screening tools; (b) provide brief intervention for individuals based on their screening score; and (c) provide referral to treatment for individuals based on their screening score.

Eligibility Criteria:
Inclusion Criteria:

* EAP/BH practitioners will be employed at an EAP or behavioral health organization
* have an e-mail account
* access to high-speed Internet connection
* speak and read English

Exclusion Criteria:

* younger than 18
* not an EAP practitioner
* no access to e-mail
* no access to the Internet
* do not speak and read English
The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections

Postpartum infection if a major cause of maternal morbidity and mortality and surgical site infections are some of the common complications following cesarean section. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.

Postpartum infection is a major cause of maternal morbidity and prolonged hospitalization, and places a large burden on the healthcare system with an additional cost of $3,700 (Olsen et al., 2010). Surgical site infection (SSI) is one of the most common post-operative complications following cesarean section, with an incidence of 3-15% worldwide (Zuarez-Eaaston et al., 2017). Wound dressings that are applied after closure of a surgical incision may help healing by providing physical support, protection from external contaminants, and by absorbing exudate (Dumville et al., 2016). A new FDA-approved microbicidial liquid adhesive, Steri3X, has been shown to reduce the incidence of pin-tract infection by 100% in a randomized-controlled trial following external fixation in patients undergoing reconstructive surgery for deformity correction (Pema, 2020). Steri3X is reported to be effective against S. aureus (both MSSA and MRSA), Candida albicans, E. coli, P. aeruginosa, and Candida auris, which are common organisms involved in dermatological infections. The most common organisms responsible for cesarean section SSI include enteric gram negative bacilli, enterococci, and group B streptococcus (Gur et al., 2015). The advantage of this polymer following C-sections is unknown, and a larger study is needed to provide a more robust analysis. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.

Eligibility Criteria:
Inclusion Criteria:

* Age 16 years old or older
* C-section patients only (primary, repeat, or stat)
* Diabetes, obesity ok to include (but not required)
* Patients receiving PCN for GBS prophylaxis ok to include (but not required)
* Application of Steri3X immediately post-op

Exclusion Criteria:

* Chorioamnionitis or other existing infection excluded (Single maternal fever \>39 C, 2 maternal fevers \> 38, or clinical risk factors for chorioamnionitis)
* Patients receiving antibiotic treatment for existing or prior infection other than PCN for GBS prophylaxis
* Patients receiving Prevena or other wound vac
* Rupture of membranes \>24 hours
Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate

This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF biologic).


Eligibility Criteria:
Inclusion Criteria

* Subjects between the ages of 18 and 75 years, inclusive
* Must have moderate-to-severe, active Rheumatoid Arthritis
* Must have had an inadequate response to Methotrexate
* Subjects may have received one approved TNF inhibiting biologic agent that was inadequately effective and/or not tolerated

Exclusion Criteria

* Subjects with any acute or chronic infections or infection history
* Have acute or active chronic dermatological disorders prior to study start
* Any major illness/condition(s) or evidence of an unstable clinical condition that in the judgment of the investigator would make the subject inappropriate for entry into this study
* Known immunodeficiency disorder or a first degree relative with hereditary immunodeficiency
* Any live (attenuated) vaccines or current routine household contact with anyone who has received live (attenuated) vaccine
Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment

Functional dyspepsia (FD) is one of most common chronic gastrointestinal disorders. Several types of drugs were demonstrated to be effective in reduction or remission of symptoms and severity of FD, including proton pump inhibitors (PPI), Tricyclic antidepressant and prokinetics. However, the clinical course of FD after taking medication-based treatment was unknown. Furthermore, 20-50% patients remained persistent or worsening of dyspepsia symptoms after treatment. Previous studies have suggested psychological factors (eg. anxiety, sleep disturbance) were related to less improvement of symptoms in natural clinical course. However, there is limited evidence in terms of clinical and psychological factors for less improvement in patients receiving medication treatment for dyspepsia.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years old
2. Patients who met Rome IV criteria
3. Normal upper endoscopy and abdominal ultrasonography within one year

Exclusion Criteria:

1. Patients with local or systemic diseases which may cause dyspeptic symptoms:

   Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; Known acute or chronic injury of liver or kidney; Obvious hematological abnormality, or endocrine and metabolic diseases; Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
2. organ failure defined by Marshall standard
3. severe psychiatric illnesses
4. known malignancy
5. pregnancy or lactation
6. unable to provide consent
7. suspected or identified bowel obstruction
The Effect of Tranexamic Acid on Postpartum Hemorrhage During and After Cesarean Delivery

Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. Term pregnancy
2. Single fetus
3. Maximally only one previous cesarean delivery

Exclusion Criteria:

1. More than one previous cesarean delivery
2. Hx of other abdominal or pelvic surgery
3. Hx of medical disorders
4. Hx of thromboembolic disorders
5. Polyhydramnios
6. Macrosomia
7. Preeclampsia
8. Hx of sensitivity to Tranexamic acid
9. Abnormal Pt, PTT, PT or INR
Evaluation of Gadolinium Deposits in Healthy Women Participating in a High Risk Screening Program for Early Breast Cancer Detection

Purpose: To determine whether patients at high risk to develop breast cancer having received at least 6 cumulative dosages of macrocyclic Gd-based contrast media in the context of breast cancer screening by means of contrast-enhanced MRI.

Methods: Diagnostic study encompassing two arms: first, 50 patients having received ≥6 dosages of macrocyclic Gd-based contrast media in the course of MRI-based breast cancer screening will undergo brain MRI assessment for signal alterations due to Gd-deposits. The second arm consists of 50 healthy volunteers that never received Gd-based contrast agents, and undergoes the same brain MRI assessment as the patient-based arm 1 of the study. Signal intensities will be compared to assess the potential presence or absence of macrocyclic Gd-based contrast agent deposits in the brain.

In case of presence of signal alterations in arm 1 these will be further stratified by number of previously administered macrocyclic Gd-contrast agent doses.

Projected outcome: High cumulative dosages of macrocyclic Gd-based contrast agent either result or do not result in brain MRI signal alterations in healthy women participating in a high-risk screening program for the early detection of breast cancer that necessitates Gd-contrast agent enhanced breast MRI at regular intervals.


Eligibility Criteria:
Inclusion Criteria:

* Female; cumulative exposure to ≥6 dosages of macrocyclic Gd-based agents in the course of breast MRI screening for breast cancer OR no exposure to Gd-based contrast media

Exclusion Criteria:

* Previous chemotherapy; serious illness including cardiovascular and neurological diseases; contraindications to MRI; exposure to non-macrocyclic Gd-based contrast agents
Hyaluronic Acid Application Following Frenectomy

This randomized clinical study aimed to compare the outcomes of the laser-assisted frenectomy with and without topical hyaluronic acid application to evaluate the effect of HA on secondary wound healing after frenectomy surgery.

The study included a total of sytemically healthy 40 patients , with high labial frenulum attachment requiring frenectomy. Following laser-assisted frenectomy operation HA gel was applied to the wound surface in the test group, and no application was made to the control group The HA application was made topically to completely cover the surgical area on days 3, 7, and 14 postoperatively. Photographs of the operation area were taken on days 3, 7, and 14. The changes in the area measurements between the digital images according to the healing periods were calculated on a computer. according to Visual Analogue Scale (VAS) was used to evaluate Patient comfort and pain levels.

the aim of this study was to clinically evaluate the effect on secondary wound healing of the topical application of hyaluronic acid to the surgical field after frenectomy operation performed with laser, through evaluation of the amount of reduction of the wound site and postoperative pain levels.The study included a total of 40 patients who had maxillary high labial frenulum attachment and were planned to undergo frenectomy and met the study inclusion criteria. All the patients were informed about oral hygiene control and attention was paid that optimal oral hygiene was maintained throughout the study. Phase I periodontal treatment was applied to patients where necessary. The area measurements of the wound site formed after frenectomy was taken immediately after the frenectomy and on days 3, 7, and 21 postoperatively. HA gel was applied topically after the frenectomy operation to the test group and not to the control group. All the surgical procedures were performed by the same surgeon.

Eligibility Criteria:
Inclusion Criteria:

* No systemic disease,
* the presence of high labial frenulum attachment diagnosed according to Mirko et al., -periodontally healthy or a requirement for periodontal treatment that would only require removing of dental plaque,
* full mouth plaque score \<15%,probing pocket depth \<3mm in all teeth
* no history of periodontal surgery.

Exclusion Criteria:

* not meet the optimal level of oral hygiene,
* had any condition that could affect wound healing,
* were pregnant or lactating,
* were cigarette smokers or were takiing any medication that might affect the outcome of the study,
Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs

The purpose of this study is to look at how Alpha-1-antitrypsin (AAT) deficiency and Cystic Fibrosis (CF) affect white blood cells in the lungs, called macrophages, and their ability to work.

AAT deficiency is a genetic disorder that affects around 100,000 people in the USA, including 1-3% of all people diagnosed with chronic obstructive pulmonary disease (COPD). In AAT deficient people diagnosed with COPD, it was originally believed the cause of the disease was due to a lack of supply of alpha-1 antitrypsin. However, early information gathered in our laboratory suggests another cause of the development of COPD and the progressing of the disease may be due to a malfunction in macrophages.

CF is also a genetic disorder which affects 1/300 births among the Caucasian population. One of the main symptoms of CF is inflammation of the lung tissue. Lung macrophages play a major role in lung inflammation as well as in helping to resolve the inflammation.

Inflammation is an important defense of the body. It is the body's response to infection causing germs and things that may cause irritation, as well as, a way for the body to repair damaged tissue.

We suggest that the effects of AAT deficiency and CF decreases the inflammation response in the lungs and also restricts the ability of macrophages to correct that inflammation once it occurs.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Male or female 18 years of age or older
* Negative pregnancy test for women of childbearing potential
* Hemoglobin \>12.5 g/dl measured on the day of participation
* Negative urine nicotine test

Exclusion Criteria:

* Pregnancy or breastfeeding
* Weight \< 50 kg
* History of anemia requiring blood transfusions, erythropoietin supplementation, or iron supplementation within the past 36 months
* Known hemoglobin \<12.5 g/dl within the past 90 days
* Systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \>100 mmHg
* Poor venous access
* Large volume blood donation (\>200 ml or 7 ounces) within the previous 56 days (e.g. blood donation for the purposes of blood banking)
* Clinically significant cardiac, hemostatic or neurological impairment or any other significant medical condition that, in the opinion of the investigator would affect subject safety (e.g., recent myocardial infarction, history of prolonged bleeding time, cerebral vascular accident, advanced cancer or uncontrolled medical condition)
* Psychiatric or cognitive disturbance or illness that would affect subject safety
* Current smoker