cyrilzakka/clinical-trials huggingface dataset:
Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2

Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. As our feasibility study demonstrates, remote breathalyzer monitoring drastically improves the practicality of delivering an alcohol contingency management intervention. In Experiment 2, we will test whether the addition of remote abstinence incentives to treatment as usual improves outpatient treatment outcomes and prevents relapse following inpatient detoxification at a regional hospital system. We will also assess whether readmission rates are reduced using a newly developed smartphone app and breathalyzer.


Eligibility Criteria:
Inclusion Criteria:

* Recently completed or currently completing an alcohol detoxification program through the Carilion Clinic or University of Kentucky Healthcare system.
* Meet DSM-V criteria for alcohol use disorder.
* Abstinent from alcohol at the time of consent.

Exclusion Criteria:

* Alcohol use disorder is secondary to another substance use disorder.
Prevention of Combat-related PTSD Using Attention Bias Modification (ABM): A Randomized Controlled Trial

Military deployment to combat zones involves exposure to trauma at a higher than average rate and therefore presents a unique opportunity to study predisposing factors to posttraumatic stress reactions and test strategies designed to prevent and ameliorate posttraumatic symptoms. Decades of scientific research on the origins of resilience and vulnerability to combat-related posttraumatic stress symptoms revealed various predisposing and protective factors. All these factors however, offer limited opportunity for systematic pre-deployment prevention efforts. Considering the magnitude of psychological adjustment difficulties encountered by combat personnel in deployment and the limited access to existing evidence-based therapies for PTSD, the development and testing of a novel evidence-based and theory-driven prevention protocol for these problems is of considerable significance. The current study translates cognitive-neuroscience knowledge and attention bias modification research into a novel computerized training tool that could be easily delivered to soldiers during different stages of the deployment cycle. If proved efficacious in reducing risk for posttraumatic symptoms ABMT could be integrated into the Army's resilience training program. Thus, we propose a longitudinal double-blind randomized controlled study of ABMT in soldiers. We will assess attention bias and symptoms before deployment, will randomly assign soldiers to either 8 ABMT sessions, 4 ABMT sessions, 8 Placebo training sessions, or no training. Following 6 months of deployment to combat zone symptoms will be assessed again.


Eligibility Criteria:
Inclusion Criteria:

* combat soldiers

Exclusion Criteria:

* Fluent Hebrew
Pilot Study Investigating the Metabolic Activity and Transcriptional Profiling in Vivo in Tumor Biopsies in Melanoma Patients During Treatment With Pazopanib Alone and in Combination With Paclitaxel

This is an open, monocentric, pilot study to determine the metabolic activity (glucose-uptake) in vivo during monotherapy with pazopanib in comparison to combination therapy with pazopanib plus paclitaxel and to investigate the transcriptional profile of cutaneous melanoma metastasis before and during the therapy (pazopanib vs. pazopanib plus paclitaxel) in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy.

Primary Objective:

Evaluation of metabolic activity in vivo

Secondary Objective:

Determination of changes in gene expression profiling Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS). Changes in S100 and LDH during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years
* Diagnosis of histologically or cytologically confirmed melanoma stage III or IV.
* Fresh tumor tissue must be provided for all subjects for biomarker analysis before (within 14 days prior to treatment start) and during (on day 10 of the pazopanib monotherapy and the last day of the treatment with pazopanib, day 70) treatment with investigational product (asservation in RNAlater, for kryo asservation, and for cell cultures)
* Assessable metastases (skin or superficial lymph nodes with a minimal diameter 1 cm)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate organ system function

Exclusion criteria:

* Prior malignancy.
* Central nervous system (CNS) metastases
* Corrected QT interval (QTc) \> 480 msecs using Bazett's formula.
* History of any one or more of the following cardiovascular conditions within the past 6 months:

  * Cardiac angioplasty or stenting;
  * Myocardial infarction;
  * Unstable angina;
  * Coronary artery bypass graft surgery;
  * Symptomatic peripheral vascular disease;
  * Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
* Poorly controlled hypertension
* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
* Presence of uncontrolled infection
* Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
* Evidence of active bleeding or bleeding diathesis
* Any ongoing toxicity from prior anti-cancer therapy that is \>Grade 1 and/or that is progressing in severity, except alopecia.
* Prior exposure to the study drug pazopanib
Study C3S : Comparison Among Healthy Subject

The aim of the C3S study is research an equivalence with longitudinal, radial and circumferential, global and segmental strain value, in left Ventricular in 2 and 3 dimension between two echograph General Electric Vivid 9 (GE Vingmed, Horton, Norway) et Philips Epiq 7.

Healthy volunteer will be inform about the study by email and press. They could join the clinical research team by email and phone to ask more questions about the study. Then the investigator, verify the eligibiliy of the volunteers and schedule an appointment for the visit of inclusion. During this visit, the patient's consent will be collected. One echocardiography will be complete on echograph General Electric Vivid 9 to collect the clinical data necessary for the study and to eliminate the presence of criteria of exclusions, the acquisition of the loops of ultrasound will be realized on both echographs by a first investigator. A second investigator will make the post-treatment of the ultrasound images on consoles ECHOPAC PC version 201, General Electric Medical System and Q Station version 3.5, Philips Healthcare in two different times, to obtain the values of the various strain.

Furthermore, an clinical exam, an ECG, a questionnary will be realized.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years' old
* Without any cardiac pathology
* Not taking long-term treatments, except oral contraception
* Consented to participate in the study

Exclusion Criteria:

* Existence of heart disease : myocardial revascularization, primitive cardiopathy (dilated or hypertrophic cardiopathy), moderate or severe valvulopathy, pulmonary hypertension, congenital heart disease operated or not, previous cardiac heart failure, previous rhythm disturbance and/or pacemaker, hypertension treated or untreated, peripheral artery disease : occlusive arteriopathy of the lower limbs, peripheral arterial aneurysm, stenosis or peripheral arterial occlusion.
* Practicing intensive sport (more than 6 hours per week)
* Untreated type 2 or 1 diabetes , treated dyslipidemia, chronic alcoholic intoxication (men more than 3 units of alcohol per day and women more than 2 units per day)
* Existence of heart disease or previous heart disease
* Pregnant or lactating women,
* Dependent adult
* Patients minor,
* Decline the study,
* Existence of a psychiatric pathology
* Inability to grant its informed consent
* No affiliation to a social security scheme
Pelvic Floor Muscle Function Among Running Women

This study will examine pelvic floor muscles function amongst women who run on a regular basis compared to controls. Women who do not run, will begin running protocol, and second evaluation will be performed following 2 months of training. Urinary incontinence will also be assessed.

The study will include women who have been running on a regular basis over two years, at least 3 times a week for half an hour (research group) and women who do not run at all (control group). The participants will answer a personal information questionnaire (including birth and exercise background), and the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF). Outcome measures will include an evaluation of the PFM function using Vaginal palpation and abdominal ultrasound examination.

Women who do not run at all, will begin running training protocol, and second evaluation will be performed following 2 months of training.

Eligibility Criteria:
Inclusion Criteria:

* at least six months after giving birth or who have not given birth at all, The running group will recruit healthy women who run at least 3 times a week, 30 minutes, for two consecutive years.

The control group will recruit healthy women who do not physical active on a daily basis

Exclusion Criteria:

* pregnancy
* grade 3 or higher of pelvic organ prolapse.
Testosterone Gel in Poor Responders Undergoing IVF

The main purpose of this study is to compare the number of oocytes retrieved after using transdermal testosterone gel 10 mg per day or Dehydroepiandrosterone (DHEA) 75mg per day for 6-8 weeks as pre-treatment for poor ovarian responders undergoing in-vitro fertilization (IVF).

A randomized controlled multiple centers study. The study is designed as a superiority trial. The sample size for this trial of 120 subjects in both groups, based upon the primary endpoint of the number of oocytes retrieved.

IVF patients who have failed to conceive and had poor ovarian response (oocytes retrieved ≤ 3) in the last stimulated cycle though using the maximal dose, which is ≥ 300 IU Follicle-stimulating hormone (FSH) or human menopausal gonadotropin (hMG).

Patients will be randomized to use DHEA or testosterone gel as pretreatment. Randomization will be performed using sealed envelopes developed via a computer generated list with blocks of four. Doctors will be blinded to the randomization, but not patients and nurses.

* Study group 1 use 10 mg transdermal testosterone gel per day.
* Study group 2 use 75mg DHEA per day.

Serum testosterone are measured before treatment. Duration of androgen supplement is 6-8 weeks. After completing the pretreatment, patients are asked to come back when they have menses to begin IVF treatment. Serum testosterone is measured again after the pretreatment in both groups. Patients will be interviewed for side effects and compliance of treatment.

After treatment, patients in both group undergo IVF treatment. IVF treatment will then be performed for all patients, according to the current hospital treatment protocols.

Patients will be followed up until 7th week of gestation, if they have positive pregnancy test after embryo transfer.

Data Analysis and Statistics:

The investigators use Statistical Package for the Social Sciences (SPSS) software 20th version to analyze data. The primary end-point mean of number of retrieved oocytes will be compared between two groups using the Student's t test. The secondary end-points will also be compared between the 2 groups using either the Student's t test or chi-square test.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for enrolment into this trial, each female subject must fulfill all of the following criteria at the start of enrolment, unless specified otherwise:

* Had one or two previous failure IVF cycle, using GnRH antagonist protocol (≥ 300 IU FSH/hMG per day) and the number of retrieved oocytes are ≤ 3;
* Antral follicle counts (AFC) \< 6 or Anti-Mullerian Hormone (AMH) \< 1.26 ng/ml

Exclusion Criteria:

To be eligible for enrolment in this study each subject must not meet any of the following criteria:

* Oocyte donation cycle
* Patients have thyroid disease
* Patients have liver or kidney dysfunction
* Patients have abnormal puberty or genital development.
* Patients have previous surgery on ovaries
Measurements of Breast Tissue Optical Properties

Approximately twelve percent of the women in the United States will develop breast cancer, the most common form of cancer affecting women, with 183,000 new cases projected for 1995. Despite the increasing incidence, the age-adjusted death rate from carcinoma has remained relatively stable. Although the reason for this has not yet been demonstrated, this stability may be a direct consequence of early detection and improved therapy. Screening mammography as an early detection technique has been shown to reduce mortality by 23%. Mammographic abnormalities that go on to biopsy show 24% being positive for malignancy with great variability (6-75%). Breast biopsy is an expensive procedure with the risks of anesthesia and surgery which may be obviated by more specific non-invasive testing.

Diffuse Optical Spectroscopic Imaging a new method for quantitative characterization of the optical properties of tissues. The diagnostic tools utilize anomalies in the transmission of diffusing near infra-red light for the rapid detection of oxygenated and deoxygenated hemoglobin, near infra-red absorbing drug levels, blood volume changes, and scattering properties in tissues.

Diffuse Optical Spectroscopic Imaging measurements of breast tissue optical properties probe is similar in shape to an ultrasound probe. The imaging can measurements on different areas of the breast including diseased location and normal area. Optical measurements can guided by co-registered ultrasound measurements for the purpose of determining lesion size and location. Each measurement will require about 5-60 seconds to record the data and calculate optical properties. The process will be repeated until an adequate number of measurements are performed and measurements take 30 to 90 minutes.

The researcher can determine that breast optical properties on demographic information, such as age and menopausal status as well as medical history.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant woman age 18 yrs and older.

Exclusion Criteria:

* pregnant woman and younger than 18 yrs of age.
Efficiency And Quality In Post-Surgical Pain Therapy After Discharge

Following inpatient surgery, more than 80% of patients are prescribed opioids for use after discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize non-opioid therapy. The proposed research seeks to test a provider-facing decision support tool and a patient-facing smartphone app to reduce the amounts of opioids prescribed and taken following discharge, while ensuring effective treatment of pain after surgery.

Prior to discharge from the hospital, patients will be approached regarding interest in the study with an introductory letter that describes the content and purpose of the study. Following informed consent, patients will be randomized to receive the consumer health informatics app (UControlPain) versus provision of an app with only data collection function (no educational components). Randomization will be implemented via REDCap by the study coordinators. Further, information on which type of app was installed will not be shared with providers or patients.

Eligibility Criteria:
Inclusion Criteria:

1. \>19-89 years old
2. Access to a smartphone (iOS or Android)
3. inpatient surgery requiring at least over-night hospitalization with anticipated discharge to home

Exclusion Criteria:

1. Patients re-hospitalized within 30 days of previous hospitalization
2. Pregnant patients
3. Patients not able to read the English language
4. Patients discharged to a post-acute care facility
5. Patients with contraindications to opioids, acetaminophen, or NSAIDs
6. Patients meeting the AHRQ definition of long-term opioid therapy (opioid use on most days \>3 months) prior to surgery.
Bicalutamide (Casodex™) Versus Placebo in Patients With Early Prostate Cancer

The purpose of this trial is to study the effect - in terms of time to progression and overall survival - of 2 years of adjuvant bicalutamide 150mg monotherapy, versus placebo, in subjects with histologically or cytologically confirmed non-metastatic adenocarcinoma of the prostate gland.


Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer in the early stage of disease
* Prostate removed and/or radiation therapy to the prostate area

Exclusion Criteria:

* Previous systemic therapy for prostate cancer
* Previous history of another form of cancer (not prostate) within 5 years of study start.
Heparin 100U/L for Prevention of PVC Complications

Flushes with saline solution are used for maintaining patency of peripheral intermittent intravenous catheters in many institution based on the results of previous studies showing that 10 U heparin/mL is not better than saline in this respect. The latest meta-analysis investigated also safety and efficacy of heparin concentrations of 100 U/ml used as an intermittent flush, but no firm conclusion was reached because of limitations of the few available studies.


Eligibility Criteria:
Inclusion Criteria:

* requiring i.v. therapy for an expected duration longer than five days
* admitted to the 3rd medical ward of IRCCS Policlinico San Matteo

Exclusion Criteria:

* bleeding tendency
* platelet count less than 100 x 109/L
* coagulation defects
* previous adverse reaction to heparin
* programmed cytotoxic therapy
* inability to give an informed consent
Can Dietitians Reduce Interdialytic Weight Gain in at Risk Hemodialysis Patients Through Tailored Education on Dietary Sodium and Fluid Intake?

The purpose of this project is to understand if more frequent education of dialysis patients (patients with kidney failure who get their blood cleaned and fluid removed by a machine instead of their kidneys) on reducing sodium intake reduces the amount of fluid weight that patients gain between dialysis sessions. Patients who usually gain more fluid than is considered ideal will be recruited for this project. Because all patients gain different amounts to start, data will be collected for 3 months while the patients receive their usual amount of dietitian education. Then the patients will receive intensive (2x/month) education on reducing sodium intake from the dietitian and the same data will be collected to see if they gain less after the education. After 3 months of intensive education, data will be collected for one more month to see if patients keep gaining less or if they go back to their old patterns.


Eligibility Criteria:
Inclusion Criteria:

* Average Interdialytic weight gain (IDWG) for 2 weeks prior to screening period greater than or equal to 4% estimated dry weight
* Able to sign the locally approved informed consent
* Willing to receive dietitian education on sodium and fluid control during normal dialysis time
* Receiving thrice weekly maintenance hemodialysis for greater than or equal to 6 months Age greater than or equal to 18 years

Exclusion Criteria:

* On hospice or international equivalent
* Receiving corticosteroid treatment
* Less than 18 years old
* On interdialytic parenteral nutrition
* Transfer to another facility expected within 3 months
* Severe malnutrition, as assessed by Subjective Global Assessment (SGA) or other standard assessment tool
Pralatrexate Combined With Chidamide Bridging Allogeneic HSCT for Refractory/Relapsed Peripheral T-cell Lymphoma

This is a multicenter, prospective study of Pralatrexate combined with Chidamide bridging Allogeneic Hematopoietic Stem Cell Transplantation for Refractory/Relapsed Peripheral T-cell Lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Patients fully understand the study, voluntarily participate in and sign on the informed consent;
* Diagnosed by histopathology Peripheral T-cell lymphoma;
* ECOG PS score 0 or 1;
* Relapsed or Refractory Peripheral T Cell Lymphoma；
* According to the 2014 version of the Lugano criteria for lymphoma, there must be at least one CT/MRI measurable lesion (measurable lymph node diameter\>1.5cm; measurable extranodal lesion diameter\>1.0cm)；
* Provided a written pathological/histological diagnosis report during the screening period and agreed to provide tumor tissue sections or tumor/lymph node tissue specimens for testing at the central laboratory;
* Expected survival at least 12 weeks；
* Agreed to receive treatment with Pralatrexate

Exclusion Criteria:

* NK/T-cell lymphoma;
* Achieving CR or PR after induction chemotherapies without relapse;
* Dysfunction of vital organs;
* Serious history of autoimmune diseases and immunodeficiency, including: positive for human immunodeficiency virus (HIV) antibodies; Or other acquired or congenital immunodeficiency diseases; Or have a history of organ transplantation;
* Unwilling to accept allogeneic hematopoietic stem cell transplantation;
* Undergoing other clinical studies within a month;
* Without donor for transplantation;
* Allergies to similar drugs and excipients of the research drug
Non - Invasive Evaluation of the Left Atrium Anatomy and Function

The aim of the study is to evaluate the accuracy and reproducibility of the left atrium (LA) anatomy and function in different populations and in patients with atrial fibrillation who have undergone cryoballoon ablation.

This study implies three parts. The first part of the study aims to evaluate the variability and reproducibility of rest two - and three-dimensional echocardiography for the left atrium anatomy and function and to assess their correlation with clinical variables.

The second part of the study aims to evaluate the accuracy and reproducibility of the left atrium anatomy and function using echocardiography and to validate it with cardiac CT. Moreover, the study aims to evaluate which parameters can predict the recurrence of atrial fibrillation in patients who have undergone atrial fibrillation ablation.

The third part of the study aims to assess the accuracy and variability of echocardiographic measurements compared to cardiac magnetic resonance and to find predictors of recurrence after cryoballoon ablation for atrial fibrillation.

Eligibility Criteria:
Inclusion Criteria:

* subsequent group of patients sent to the echocardiography laboratory for any indication/patients who have undergone a cryoballoon ablation
* older than 18 years old

Exclusion Criteria:

• inadequate image quality during echocardiography, contraindications for computed tomography or cardiac magnetic resonance