cyrilzakka/clinical-trials huggingface dataset:
Tamsulosin to Prevent Postoperative Urinary Retention in Laparoscopic Inguinal Hernia Repair

To investigate the effect of tamsulosin on the development of post-operative urinary retention (PUR) after elective laparoscopic inguinal hernia repair (LIHR). This will be accomplished by administering a pre-operative dose of tamsulosin. The primary outcome is the rate of urinary retention necessitating straight catheterization or insertion of foley catheter prior to discharge.

Patients who are scheduled for elective laparoscopic inguinal hernia repair will be consented in the office by the attending physician. An order will be placed during surgery scheduling for tamsulosin with instruction to administer one dose in the preoperative holding area on the day of surgery. The Jewish hospital pharmacy will be responsible for providing randomization and placebo medications for double blinding effect. PUR will be tracked on the basis of urinary catheterization performed prior to hospital discharge. Criteria for catheterization include: i) Inability to urinate within 6 hours post-operatively, and bladder scan showing \>400 mL. ii) Inability to urinate at any time postoperatively with symptoms of urinary retention (i.e. urgency, bladder discomfort). Women of childbearing age will need to have a confirmed negative urine or serum pregnancy test prior to surgery. This will be completed on arrival to the preoperative holding area.

To detect the difference between the treated group and control group with a significant alpha (0.5) and power (80%), at least 178 patients will be needed in each group. This was generated using the Pearson Chi-square test for Two proportions.

This study will be conducted in the hospital setting at a single institution. Patients will be consented for the study in the pre-admission holding area and followed until discharged from the post anesthesia care unit.

Eligibility Criteria:
Inclusion Criteria:

1. All patients undergoing elective laparoscopic inguinal hernia repair, unilateral or bilateral.
2. ≥18 years of age.
3. Patients must leave the operating room without at indwelling urinary catheter.

Exclusion Criteria:

1. History of neurogenic bladder requiring routine intermittent catheterization
2. Emergent laparoscopic hernia repair.
3. Elective laparoscopic hernia repair in conjuncture with an additional operation (e.g. nephrectomy, pelvic surgery) that requires the patient to have a planned, indwelling urinary catheter in the postoperative period.
4. Pregnant women.
Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine

The aim of this randomized clinical study is to show non-inferiority of a change of anti-viral therapy from telbivudine to lamivudine in patients who have achieved an undetectable viral load at week 24 of telbivudine therapy compared to continuous treatment with telbivudine with respect to the viral breakthrough rate at week 108 as the primary clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, \> 18 (having completed their 18th birthday). There is no upper limit of age
* Documented HBeAg negative CHB
* HBsAg positive \> 6 months
* HBV DNA \> 2000 IU/mL
* Patient is willing and able to comply with the study drug regimen and all other study requirements.
* Written informed consent
* Anti-viral HBV treatment naïve or previous treatment with interferon-alpha or pegylated interferon-alpha stopped at least 1 month prior to screening

Exclusion Criteria:

* Decompensated liver cirrhosis according to the judgment of the local investigator
* Hepatocellular carcinoma
* History of or laboratory signs of co-infection with HIV or HCV, HDV
* Previous treatment with anti-viral drugs (previous treatment with interferon-α or pegylated interferon-α is not an exclusion criteria, but has to be stopped one month before screening)
* History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures or their excipients
* Any medical condition that requires frequent or prolonged use of systemic corticosteroids (inhaled, topic or intra-articular corticosteroids are allowed)
* Any medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs.
* Current abuse of alcohol or illicit drugs.
* Use of other investigational drugs at the time of randomization, or within 30 days or 5 half-lives of enrollment, whichever is longer.
* Any other concurrent medical or social condition which is, in the opinion of the investigator, likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study.
* Any of the following laboratory values during Screening:

  * Hemoglobin (HGB) \<11 g/dL for men or \<10 g/dL for women
  * Total WBC \<3000/mm3
  * Absolute neutrophil count (ANC) \<1,500.mm3
  * Platelet count \<50'000/mm3
  * Serum amylase or lipase ≥ 1.5 x ULN
  * Serum albumin \<3 g/dL
  * Total bilirubin \> 51 μmol/L (\> 3.0 mg/dL)
  * Estimated calculated serum creatinine clearance \< 50 mL/min using the Cockcroft-Gault method using actual or ideal body weight whichever is less (Cockcroft and Gault 1976)
  * AFP (alpha-fetoprotein) \> 100 ng/mL
  * ALT \> 10x ULN
* Women who are pregnant or breastfeeding. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) during Screening.
The Lasting Change Study

The study approach is to leverage the most cutting-edge techniques of multi-omics biology, wearable physiology, and digital real-time psychology profiling and using machine learning models to understand the mechanisms underlying the strategies and techniques that enable participants the power to initiate and maintain sustainable behavior change.

Over the years, millions of people worldwide have attended immersive personal development seminars aiming to improve participants' health behaviors and wellness. Nevertheless, there's a scarcity of large-scale studies to assess their effects on behavior change and investigate their mechanism of action. A recent publication by the Science of Behavior Change Program (SOBC), launched by the National Institute of Health (NIH), recognized that: "science has not yet delivered a unified understanding of basic mechanisms of behavior change across a broad range of health-related behaviors, limiting progress in the development and translation of effective and efficacious behavioral intervention." As such, understanding the mechanisms underlying sustainable behavior change is key.


Eligibility Criteria:
Inclusion Criteria:

* 18-years-old and older
* English speaker
* Live in the US
* Participate in the DWD seminar (December 2-7, 2022)

Exclusion Criteria:

* Any physical or mental condition that limits the ability to participate in the study (e.g., answering e-questionnaires and wearing an electronic device)
* Serious active comorbidity or terminal illness
* Pregnancy
* Participation in any other clinical study focusing on psychological or behavioral intervention.
Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (upper extremity) is more effective at preventing infection than the current standard dose which is given intravenously (IV).


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing upper extremity reconstruction by a single surgeon.
* Surgical cases will include:

  * Trapeziectomy/suspensionplasty.
  * PIPJ/MPJ arthroplasty.
  * Proximal row carpectomy.
  * Distal ulnar resection.
  * Distal radius fracture fixation.

Exclusion Criteria:

* Inability to adequately cannulate a superficial vein in the upper extremity within 5 minutes of tourniquet inflation.
* Evidence of subcutaneous extravasation in Bier block group.
* History of renal dysfunction.
* Vancomycin allergy.
* ASA\>/= 3.
* History of lung cancer.
* Known HIV infection.
* History of organ transplantation.
A French Multicenter Observational Retrospective Study of Rare Primary Liver Cancers

The aim of this French multicenter retrospective study is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences. This retrospective cohort will be the backbone of future translational studies aimed at identifying new molecular, histological, circulating and radiological tumor biomarkers, potentially useful at every stage of diagnosis and prognostic or theranostic evaluation.

The aim is to describ rare primary hepatic cancers clinical, histological and radiological features, to obtain a biological tumor and blood collection, and to evaluate the efficacy of treatments received in clinical practice in order to determine optimal therapeutic sequences.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older,
* with histologically proven hepato-cholangiocarcinoma, fibrolamellar hepatocellular carcinoma, epithelioid hemangioendothelioma or hepatic angiosarcoma
* diagnosed after January 01, 2018 living or deceased at the time of registration in the cohort
* for living patients who have not objected to the research: (note of non-objection to be attached° agreeing to participate in ancillary studies must sign the biological consent form for participation in biological studies.

Exclusion Criteria:

* without social security
* No access to tumor block
COMP.ACT for Chronic Pain Exercises in an ACT Group Intervention for Chronic Pain

This study tests the efficacy of adding explicit self-compassion meditation exercises in an ACT intervention for chronic pain (COMP.ACT). COMP.ACT is an 8-session, 2h each, psychological intervention for women with chronic pain. Half of participants will receive an ACT intervention + 2 Q\&A sessions, and half of participants will receive an ACT intervention + 2 compassion-focused sessions with explicit self-compassion exercises.

Acceptance and Commitment Therapy (ACT) is a transdiagnostic approach, with empirical support in adapting to several chronic health conditions, such as chronic pain (CP), and its main purpose is to improve functioning and decrease interference of pain with valued life goals. Although the American Psychological Association (APA) has stated ACT as having empirical support in CP (http://www.div12.org/PsychologicalTreatments/treatments/chronicpain_act.html), with several studies showing its efficacy, there is still room for improvement. This might be attained by adding theoretically compatible components such as self-compassion. Although ACT has recently incorporated self-compassion as one of its outcomes, this has not been considered in any ACT intervention study for CP. Compassion-based approaches has been effective in targeting self-criticism, and has been effective in reducing a large array of psychopathological symptoms that are also common in CP (e.g. depression and anxiety). The current study aims to test the adding value of explicit self-compassion exercises in an ACT group intervention for CP.

General study design Participants previously diagnosed with CP by a physician will be assigned into two different conditions/groups: a group intervention for CP that includes explicit self-compassion exercises (COMP.ACT); and a group intervention that does not include explicit self-compassion exercises (ACT). The efficacy of COMP.ACT will be assessed by comparing it with the ACT condition.

Sample This study aims to focus on musculoskeletal CP as it is the most common cause of CP. Also, the study will recruit women with CP. Patients will be provided a study description, a consent form and the research team contact for further clarifications.

The COMP.ACT protocol has the following goals: (a) promote engagement in meaningful and effective activities, even with pain and distress, (b) improving present-focused awareness and acceptance of thoughts, feelings, and physiological sensations; (c) developing a self-compassion stance towards personal difficulties, and (d) promote commitment and engagement with valued actions.

Eligibility Criteria:
Inclusion Criteria:

* chronic pain diagnosis(es),
* age between 18-65,
* residence in center region of Portugal,
* Availability to attend sessions.

Exclusion Criteria:

* Symptoms of psychosis,
* Non-suicidal self-injury,
* Suicide ideation,
* Severe Depression,
* Substance Abuse.
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects

This protocol represents the first in human study of TUTI-16, and is being conducted to establish the safety and human immunogenicity (anti-HIV-1 Tat titers) of subcutaneously administered TUTI-16. Activity of TUTI-16 will also be determined in minimizing HIV-1 viral loads and sustaining CD4+ T-cell levels.

HIV-1 Tat protein, a virally encoded toxin, is secreted by HIV-1 infected cells and acts on uninfected cells, rendering them permissive for HIV-1 replication. HIV-1 Tat enhances chronic viral replication and induces immune suppression. Antibodies to Tat inhibit this Tat-mediated transcellular activation in vitro and minimize chronic plasma viremia. HIV-1 Tat activities can be blocked in vitro and in vivo by anti-Tat antibodies.

The Thymon Universal Tat Immunogen (TUTI-16) is a fully synthetic, self-adjuvanting lipopeptide vaccine that is water soluble and administered by subcutaneous injection. In preclinical studies, a priming dose and a three week boost in rats induced a high titer antibody response to the eight known distinct epitope variants of HIV-1 Tat protein. These antibodies block the function of the HIV-1 Tat protein (toxin), which is essential to the maintenance of chronic HIV-1 viremia. Therefore, TUTI-16 has potential as a therapeutic vaccine for HIV-1 in humans.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females
* Age ≥18 and ≤50 years at Screening
* HIV-1 seropositive
* asymptomatic and in generally good health
* no prior anti-retroviral therapy within 6 months of screening
* viral load ≥ 3,000 ≤ 100,000 HIV-1 RNA copies/mL
* CD4+ T-cell count ≥ 400/mm3.

Exclusion Criteria:

* Pregnant/nursing females
* positive for HBV or HCV
* acute Herpetic event
* any clinically significant out-of range laboratory value
* subject is unable or unwilling to discontinue during the study
* participation in another investigational drug/vaccine study within 30 days preceding the first injection of investigational agent in this study.
Web-based Personalized Feedback for University Students

Excessive alcohol consumption in university students continues for be a serious public health concern with a variety of negative consequences. There have been a number of different brief interventions developed to address this issue among university students. The current project will add to this literature by evaluating the use of a personalized feedback intervention (www.CheckYourDrinkingU.net; CYDU). Specifically, this trial will examine whether providing access to the CYDU will result in short-term reductions in drinking. This issue is important as use of these interventions is not a mandatory requirement for university students so the issue is whether making materials of this type available leads to any reductions in risky drinking. It is hypothesized that students provided access to the CYDU will display greater reductions in drinking at a six-week follow-up as compared to students who were not provided access to the CYDU.


Eligibility Criteria:
Inclusion Criteria:

* AUDIT-C score of 4 or more at baseline

Exclusion Criteria:

-
A Study Using Human Papillomavirus (HPV) DNA Testing to Detect HPV-Related Oropharyngeal Cancer (OPC)

The researchers think that a blood test (NavDx®) may be able to identify cancer early by looking for circulating DNA from Human Papillomavirus/HPV. Circulating DNA are small pieces of genes that are released into the bloodstream. The purpose of this study is to find out whether using this blood test to test for HPV DNA will help detect HPV-related Oropharyngeal Cancer/OPC.


Eligibility Criteria:
Inclusion Criteria:

* Ages 45 and older
* Self-reported history of four or more lifetime sexual partners
* Self-reported history of one or more lifetime oral sexual partner
* No previous history of diagnosed HPV-related head and neck cancer

Exclusion Criteria:

* History of diagnosed HPV-related OPC
* Less than three sexual partners in lifetime
* No history of oral sex performed
* Younger than age 45
Pharmaceutical Care in Ambulatory Hemodialysis Patients

The purpose of this study is to evaluate the effectiveness of pharmaceutical care, compared to usual care, in improving medication adherence behaviour of ambulatory hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or more
* Chronic renal patients undergoing regular hemodialysis
* Receiving their scheduled medications (at least one drug)

Exclusion Criteria:

* Unable to answer the questionnaire or to sign the informed consent form
* Inability to obtain prescription drugs
Patient Navigation in Cancer Survivorship at a Safety Net Institution

This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan.

This study seeks to enroll patients receiving a Survivorship Care Plan following curative therapy for cancer. Participants will be randomly assigned to receive usual care or to be followed by a Patient Navigator as part of their Survivorship Care Plan.

Study participation for all participants will be for up to 9 months, with study visits approximately every 3 months, based on standard clinical follow-up. All participants will be administered quality of life surveys by a Clinical Research Associate at study entry, mid-study (approximately 3-6 months) and at study completion.

The following factors will be compared between arms:

* Missed/kept appointments
* Use of urgent/emergent care
* Quality of Life in relation to survivorship care
* Participants lost to care

Eligibility Criteria:
Inclusion Criteria:

* Stage I, II, III or IVa Cancer diagnosis (may include Solitary plasmacytoma, Diffuse Large B-Cell Lymphoma (DLBCL), ductal carcinoma in situ (DCIS) of the breast)
* Completed treatment with curative intent within the past 12 months. (May be on maintenance therapy.)

Exclusion Criteria:

* Distant Metastatic disease
* Non-curable disease
* Recurrence of disease prior to enrollment
* Require ongoing navigation from the treatment navigator
* Enrolled/active in another randomized study (Project SUPPORT)
Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS

Multiple Sclerosis (MS) is a chronic, autoimmune, neurodegenerative disease; clinical events are mainly attributed to myelin destruction and inflammatory of the central nervous system.

The diagnosis resides in clinical and radiological criteria according to 2017 McDonald criteria.

Once the diagnosis of MS has been made, treatment should be initiated promptly, in order to delay the onset of severe disability in the long-term, even more ocrelizumab are a treatment of high efficacy.

Ocrelizumab is used as a first-line or second-line treatment in Relapsing Remitting MS (RRMS) It is an anti-CD20 monoclonal antibody that provides rapid depletion of circulating CD20+ B lymphocytes by complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity.

The main objective is the retrospective evaluation of the impact of ocrelizumab on the outcome of MS.

The secondary objective is the search of predictive factors of response to treatment.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Suffering from relapsing-remitting MS (RRMS)
* Supported in a neurology department at Strasbourg or Nancy University Hospital between 10/01/2018 and 11/31/2020.
* Treated with ocrelizumab 600mg every 6 months during the period from 01/10/2018 to 01/05/2020.
* Have had an M0, M3 / M6 and M12 MRI after initiation of treatment.
* Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Primary progressive multiple sclerosis (MS-PP), secondarily progressive (MS-SP)
* Subject not meeting all the inclusion criteria
* Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.)
* Subjects under safeguard of justice
* Subject under guardianship or guardianship
Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation

The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.

The ALIGN study is a single arm, prospective study. The objective of the study is to investigate the safety and performance of a catheter-based plication device intended to reduce the circumference of the dilated mitral valve. The study will enroll up to 50 subjects from up to 5 sites (Paraguay, Columbia, Dominican Republic, Brazil, and India) who will be followed for 36 months post index procedure. Enrollment is defined at the time the study device is inserted into the body and patients will be followed at 30 days, and Months 6, 12, 24 and 36 post index procedure.

Eligibility Criteria:
Inclusion Criteria:

* NYHA II-IV
* Structurally normal mitral valve
* At least Grade 2 mitral regurgitation
* Left ventricular ejection fraction not less than 20% and not greater than 45%
* Left ventricular end diastolic diameter not less than 5.0 cm and not greater than 7.5 cm

Exclusion Criteria:

* Pregnant or lactating female
* Mitral stenosis
* Mod/severe aortic stenosis or regurgitation
* Mod/severe tricuspid stenosis or regurgitation
* Endocarditis
* Previous mitral valve repair or MV replacement
* Bioprosthetic or mechanical aortic valve
* Known unstable angina or MI within 30 days prior to procedure
* CVA within past 6 months
* Known contraindications to blood transfusion, contrast dye, DAPT