cyrilzakka/clinical-trials huggingface dataset:
TriVerity in the Diagnosis and Prognosis of Emergency Department Patients With Suspected Infections and Suspected Sepsis

This study will analyze gene expression and other laboratory data from biological samples collected from participants with suspected respiratory, urinary, intra-abdominal, and/or skin \& soft tissue infections; or suspected sepsis of any cause.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 year
2. Suspected acute infection (respiratory, urinary, abdominal, skin \& soft-tissue), and at least one of the symptoms OR, Suspected sepsis of any cause as defined by a blood culture order by the treating physician, and at least two of the symptoms:

   * Heart rate: \>90 beats/ minute
   * Temperature: \>38 C or \<36C
   * Respiratory Rate: \>20 breaths / minutes or PaO2 of \<60 mmHg or SpO2 \<90%
   * Systolic blood pressure: \<100 mmHg
   * Altered mental status: Per clinical exam
3. Able to provide informed consent, or consent by legally authorized representative.

Exclusion Criteria:

Participants will be ineligible for this study if they meet any of the following criteria:

1. Patient-reported treatment with systemic antibiotics, systemic antiviral agents or systemic antifungal agents within the past 7 days prior to the emergency department study visit. Participants will not be excluded for use of:

   1. Antiviral treatment for HIV infection and hepatitis B and hepatitis C
   2. Topical antibiotics, topical antiviral or topical antifungal agents
   3. Anti-herpes prophylaxis aiding suppression of a recuring herpes infection
   4. Peri-operative (prophylactic) antibiotics
   5. A single dose of antimicrobials during the present ED visit (\<10h before blood draw); note single dose can be considered mono or combination therapy, wherein combination is administered as part of local Standard of Care and only one dose of each medication is administered within the allowable 10-hour window
2. Patients receiving palliative or hospice care, or those receiving limited interventional care.
3. Prisoners, mentally disabled, or unable to give consent. Should the patient not be able to provide informed consent the legally authorized representative can provide the consent on behalf of the patient.
4. Patients receiving experimental therapy or already enrolled in an interventional clinical trial in which a subject receives some type of intervention, which can include but is not limited to investigational drugs, medical devices, or vaccines.

   a. Subjects that are enrolled in non-interventional or observational clinical trials will be allowed to participate in this clinical trial.
5. Patients previously enrolled in the present clinical trial.
Timing Personalized Feedback After Alcohol Health Education

Heavy episodic alcohol use within the college student population is widespread, creating problems for student drinkers, their peers, and their institutions. Negative consequences from heavy alcohol use can be mild (e.g., hangovers, missed classes), to severe (e.g., assault, even death). Although online interventions targeting college student drinking reduce alcohol consumption and associated problems, they are not as effective as in-person interventions. Online interventions are cost-effective, offer privacy, reduce stigma, and may reach individuals who would otherwise not receive treatment.

In a recently completed randomized, controlled trial, an emailed booster with personalized feedback improved the efficacy of a popular online intervention (Braitman \& Henson, 2016). A second randomized, controlled trial confirmed efficacy for students of legal drinking age for a longer timeline (Braitman \& Lau-Barraco, 2018). Although promising, the booster incorporated in the study needs further empirical refinement.

The current project seeks to build on past progress by further developing and refining the booster. In particular, to identify the most efficacious timing for sending the feedback. The content will be similar across conditions, but will be disseminated at different times to identify the most impactful timeline. There will be 6 study conditions: those who receive the emailed feedback 2, 6, 10, or 14 weeks after baseline, or at all of those times, or not at all (control). Thus, the aim of the current study is to identify optimal timing for sending the tailored booster feedback via booster email.


Eligibility Criteria:
Inclusion Criteria:

* Current college students at the sponsor institution at the time of enrollment
* Between the ages of 18 and 24
* Consumed at least standard drink of alcohol in the past 2 weeks

Exclusion Criteria:

* Under age of 18
* Over age of 24
* Not a college student
* Did not drink alcohol in the past 2 weeks
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalation Study in Healthy Subjects

This is a single center, randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the trial procedures and possible adverse events, volunteers to participate in the trial, and provides written informed consent.
2. Be able to comply with all the requirements and able to complete the study.
3. Male or female aged between 18 years and 55 years (inclusive) at the date of signed consent form.
4. No clinically significant abnormalities in medical history, general physical examination, vital signs, and laboratory tests.
5. Men and women of childbearing potential (WOCBP) must agree to take effective contraceptive methods and have no plan to have a child from signing the consent form to 16 weeks after IP administration.

Exclusion Criteria:

1. Positive hepatitis B virus (HBsAg), hepatitis C virus (HCV-Ab), human immunodeficiency virus (HIV-Ab), or QuantiFERON-TB Gold tests at screening;
2. Participation in clinical trials of other investigational drugs or medical devices within 3 months prior to screening (according to the date of signed consent form), or in the follow-up period of a clinical study
3. Severe injuries or surgeries within 6 months before screening or plan to do surgeries during the trial
4. Any other circumstances that, in the investigator's judgment, may increase the risk associated with the subject's participation in and completion of the study or could preclude the evaluation of the subject's response
Study of the Efficacy and Safety of Apricitabine, a New NRTI, to Treat Drug-resistant HIV Infection

Apricitabine is a new NRTI which is active against drug-resistant HIV. NRTIs are often included as part of patients' treatment, but many HIV-infected patients develop resistance to commonly used NRTIs such as lamivudine (3TC) and emtricitabine (FTC). This study will examine whether including apricitabine as part of patients' treatment is more effective than including lamivudine,when patients change treatment because of drug resistance.

ATC has potent antiviral activity both in vitro (against wild-type HIV-1 and HIV-1 with mutations in reverse transcriptase that confer resistance to NRTIs), and in clinical studies in both treatment-naïve and treatment-experienced patients with M184V, including in the presence of additional NRTI mutations in reverse transcriptase.

The M184V mutation is most commonly present amongst patients failing regimens containing either of the two deoxycytidine analogs lamivudine and emtricitabine. Whilst lamivudine therapy is often maintained in patients harboring the M184V mutation in some settings, there are no deoxycytidine analogs currently available that effectively suppress replication of HIV-1 containing the M184V/I mutation, particularly in the presence of other additional NRTI mutations.

The purpose of this study is to extend the efficacy and safety established in study AVX-201 of ATC in patients who are HIV-1 infected and have failed treatment with lamivudine or emtricitabine and have confirmed M184V/I mutation. Patients to be enrolled will be failing their current lamivudine- or emtricitabine-containing regimen and therefore have limited remaining NRTI treatment options. This study will investigate whether it is possible to improve control of HIV-1 viral replication by including ATC within a treatment experienced patient's new optimized background regimen following ART treatment failure.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 positive with M184V/I mutation in reverse transcriptase;
* 18 years of age or older;
* Currently taking lamivudine (3TC) or emtricitabine (FTC)

Exclusion Criteria:

* Female patients who are pregnant or breastfeeding;
* Current hepatitis B virus (HBV) infection;
* Current treatment for hepatitis C virus infection;
* Renal function not adequate
Comparison of Liver and Renal Function After Transarterial Chemoembolization for Primary Hepatocellular Carcinoma With Iso-osmolar Contrast Media and Low Osmolar Contrast Media

Primary Hepatocellular Carcinoma (PHC) is one of the most common malignant tumors in the world. In men is the fifth most frequently diagnosed cancer worldwide but the second most frequent cause of cancer death. In women, it is the seventh most commonly diagnosed cancer and the sixth leading cause of cancer death. An estimated 748,300 new liver cancer cases and 695,900 cancer deaths occurred worldwide in 2008. Half of these cases and deaths were estimated to occur in China. Surgical resection and liver transplantation can be curative treatment options, but less than 20% of PHC patients are candidates for surgery. The prognosis of patients with unresectable PHC is poor; if left untreated, the median survival is less than 6 months. Since transarterial chemoembolization (TACE) was introduced as a palliative treatment in patients with unresectable HCC, it has become one of the most common forms of interventional therapy. However, the possibility of treatment-related complication may offset the survival benefit, especially by the worsening of liver functions.TACE increases several parameters of hepatic cytolysis and decreases the metabolic activity of the liver. Such a deterioration of liver function due to ischemia following TACE may result in liver failure, or even death. TACE also may have an adverse effect on the kidney. Radiographic contrast medium is used to obtain the hepatogram before TACE. It has been shown that the use of contrast medium increases the risk of renal failure, especially the low-osmolar contrast media. The aim of this trials was to compare the change of liver and renal function after TACE for HCC of iso-osmolar contrast media with that of low-osmolar contrast media.

This was a prospective, randomized, single centre, single-blind study. Patients were randomized (1:1) to use Low-osmolar contrast media or iso-osmolar contrast media for TACE.

On the morning of 2th and 5th days after TACE, a hematologic check was performed, the hematologic check including serum creatinine, blood urea nitrogen, direct bilirubin, indirect bilirubin, alanine aminotransferase, aspartate aminotransferase, γ-glutamyltransferase, lactate dehydrogenase, alkaline phosphatase, cholinesterase. Then, comparing them with the data before TACE.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years;
* PHC that could not be treated with surgery;
* Patients with clear consciousness，Cooperation;
* Informed consent: authorization and signature.

Exclusion Criteria:

* Preexisting dialysis;
* Known hypersensitivity to the contrast media;
* Complete portal vein thrombosis (main trunk or both branches);
* With severe cardiovascular or renal disease;
* Extensive arteriovenous shunting;
* Insufficient function of the remaining liver (Child-Pugh class C).
Comparison of Vaginal and Transdermal Oestrogen Before Frozen Thawed Embryo Transfer

The purpose of this study is to compare pregnancy outcomes of frozen-thawed embryo transfer after endometrial preparation with vaginal estradiol or transdermal estradiol and to evaluate women's satisfaction

Frozen-thawed transfer embryo are more and more frequent but to date, there is no consensus on the ideal management of the adequate endometrial preparation.

Artificial preparation of endometrium is commonly used in assisted reproduction center because it is more easy to schedule.

Estradiol could be administrate by oral, vaginal or transdermal, but no protocol seems to improve clinical pregnancy rates.

To investigator's knowledge, transdermal estradiol has never been compare to vaginal administration before frozen-thawed embryo transfer.

Because transdermal administration could improve satisfaction of patients and reduce duration of treatment (when compare to oral administration), the investigators conduct a prospective study to compare clinical pregnancy rate after transdermal or vaginal estradiol administration to prepare the endometrium before frozen-thawed embryo transfer.

The investigator also evaluate side effects and patients satisfaction in both protocol.

The patients choose if they prefer vaginal or transdermal protocol after receiving sufficient information during medical consultation.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 and \<43
* frozen-thawed embryo transfer after exogenously administered estrogen in either way transdermal or vaginal
* patients who accepted being included and signed the consent forms.

Exclusion Criteria:

* patient who refuse to participate
* frozen-thawed embryotransfer after stimulated or natural cycle
* oocyte or sperm donation
* endometrial thickness after 21 days \<6mm
* non-french speaking patients
* women under legal guardianship
* women with no health or social security coverage
Screening for Endometrial Abnormalities in Overweight and Obese Women

The purpose of this study is to develop an endometrial biopsy screening program for endometrial cancer and its precursor lesions in overweight and obese women.

There is a BMI threshold at and above which optimal screening parameters exist for identifying endometrial cancer and its precursor lesions in overweight and/or obese women. Prevention, diagnosis and treatment of endometrial cancer and its precursor lesions in overweight and/or obese women offers substantial health benefits.


Eligibility Criteria:
INCLUSION CRITERIA:

* Have BMI ≥25.
* Be patients of the St. Luke's and Roosevelt Gynecology Clinics and Faculty Practices OR be receiving bariatric surgery.
* Complete a full medical history, a detailed menstrual and/or postmenopausal bleeding history, and endometrial biopsy.
* Have a negative pregnancy test, if of childbearing age.
* Be at least 18 years of age.
* Have signed a written Informed Consent Document.
* Be willing and able to comply with the study requirements.

EXCLUSION CRITERIA:

* Have a BMI \<25.
* Have a prior hysterectomy.
* Be pregnant or have a positive pregnancy test
* Have untreated vaginal, cervical, or adnexal infection.
* Recent treatment of STD
CBD Cigarettes Instead of Normal Cigarettes as Innovative Treatment for Schizophrenia

Interventional study using Cannabidiol containing cigarettes as replacement of usual cigarettes

Reduction of enforcement measures, improved acute treatment, harm reduction, and improvement of psychotic symptoms


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia or Related Disorders
* PANNS \> 21,
* Tobacco-smokers
* inpatient status
* within age 18 - 65 years
* German-speaking

Exclusion Criteria:

* personality disorder
* non-smokers
* organic psychotic diseases
* breast feeding
* pregnancy
Study Evaluating LXR-623 in Healthy Japanese Adults

The purpose of this study is to evaluate the safety of LXR-623 in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, Japanese Males aged 20-45 years

Exclusion Criteria:

* A history or active presence of clinically important medical disease
Treatment of Anal Incontinence With Intersphincteric Implants

The purpose of this study is to determine whether treatment with intersphincteric implants is an effective and safe treatment option for patients with anal incontinence

Treatment of anal incontinence (AI) remains a challenge - although conservative treatment can reduce the severity of many patients' AI, many continue to experience symptoms that severly affect their quality of life and ability to function properly both socially and professionally.

The level of AI is measured with the St Marks score (ranging from 0-24 where zero is complete continence).

Some patients with AI are shown to have defects in the anal sphincters (i.e. traumatic lesions post partum) and can be helped with reconstructive surgery. These procedures are effective but carry substantial risk for postoperative infection, and the healing process is painful.

One of the main treatment options for anal incontinence today is Sacral Nerve Stimulation (SNS), which is an effective but invasive and expensive treatment with a rather high level of infection. It is normally performed in two separate sessions and require life-long follow up and new surgical procedures every 6-7 years.

Historically artificial anal sphincters have been studied and shown to be effective but with high rates of infections leading to removal of the device. In more recent years studies have instead focused on "bulking agents" (injection of i.e. silicone in the submucosal space with the aim to increase the resting pressure of the anal canal), but the effect seems to be limited and the agents injected are rapidly resorbed by the body.

Treatment with intersphincteric implants is a novel treatment option for these patients. Available studies have shown good results regarding effect and a low frequence of postoperative infections. The implants rarely dislocate and are not resorbed by the body, which contributes to their long-term effectiveness. The operation is performed under a short general anaesthesia and in available studies the postoperative symptoms are few. The first technique described was called Gatekeeper (six implants), and this has since been completed by the Sphinkeeper (ten implants), which is the focus of the present study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.
2. Subject must be at least 18 years of age
3. Subject must have a St Marks score of at least 11
4. Subject must be able to comply with study and study follow-up requirements.

Exclusion Criteria:

1. Subjects with Crohn's disease or Ulcerative colitis
2. Subject has (a history of) malignancy in the rectum or anal canal
3. Subject has an ongoing treatment with chemotherapy (all indications)
4. Subject has verified active anal fistula(e)
5. Subject is unable or unwilling to provide informed consent.
Efficacy of Er,Cr:YSGG Laser in Partial Pupotomy

The aim of this study was to compare the efficacy of partial pulpotomy treatment using MTA and Er,Cr:YSGG + MTA in permanent immature molar teeth with deep dentin caries. The study was performed in children aged between 6-15 who had at least one deep dentine caries in permanent immature molar tooth. The patients' therapies were completed in Kırıkkale University, Faculty of Dentistry, Department of Pediatric Dentisry. A total of 90 teeth (caries exposed) were included in the study. According to the treatment, the teeth were randomly divided into two groups: 1. MTA group (n=45), 2. Laser+MTA group (n=45). In the MTA group, after removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl. In the same session, the tooth was restored with resin modified glass ionomer cement and composite resin. In the laser+MTA group, the treatment procedures were the same as the MTA group, and before the MTA condensation, Er, Cr: YSGG laser was applied to the exposure area after bleeding control to provide biostimulation. Patients were called for followup appointments at 1, 3, 6 and 12 months after treatment and control radiographs were taken.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of immature molar tooth with deep dentin caries.

Exclusion Criteria:

History of any systematic disease Uncompliance with dental treatment
Study CB-839 in Combination With Nivolumab in Patients With Melanoma, Clear Cell Renal Cell Carcinoma (ccRCC) and Non-Small Cell Lung Cancer (NSCLC)

This study is an open-label Phase 1/2 evaluation of CB-839 in combination with nivolumab in participants with clear cell renal cell carcinoma, melanoma, and non-small cell lung cancer.


Eligibility Criteria:
Addition eligibility criteria based on tumor type apply

Inclusion Criteria:

* Ability to provide written informed consent in accordance with federal, local, and institutional guidelines
* Histological or cytological diagnosis of metastatic cancer or locally advanced cancer that is not amenable to local therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Life Expectancy of at least 3 months
* Adequate hepatic, renal, cardiac, and hematologic function
* Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria
* Resolution of treatment-related toxicities except alopecia

Exclusion Criteria:

* Unable to receive oral medications
* Unable to receive oral or intravenous (IV) hydration
* Intolerance to prior anti-PD-1/PD-L1 therapy
* Prior severe hypersensitivity reaction to another monoclonal antibody (mAb)
* Any other current or previous malignancy within 3 years except protocol allowed malignancies
* Chemotherapy, TKI therapy, radiation therapy or hormonal therapy within 2 weeks
* Immunotherapy or biological therapy, or investigational agent within 3 weeks (Note: Some cohort exceptions allow anti-PD-1 therapy)
* Active known or suspected exclusionary autoimmune disease
* Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other systemic immunosuppressive medications within 2 weeks
* History of known risks factors for bowel perforation
* Symptomatic ascites or pleural effusion
* Major surgery within 28 days before Cycle 1 Day 1
* Active infection requiring parenteral antibiotics, antivirals, or antifungals within 2 weeks prior to first dose of study drug
* Patients who have human immunodeficiency virus (HIV), Hepatitis B or C
* Conditions that could interfere with treatment or protocol-related procedures
* Active and/or untreated central nervous system (CNS) disease or non-stable brain metastases