cyrilzakka/clinical-trials huggingface dataset:
ELIQUIS (APIXABAN) Regulatory Post-Marketing Surveillance In Clinical Practice for Venous Thromboembolism (VTE) Treatment and Prevention Of Recurrent VTE

The primary objectives of this study is to estimate the real-world safety profile of Eliquis in Japanese Venous Thromboembolism patients and to estimate the risk factors likely to affect the incidence of bleeding. Lastly, the secondary objective of this study is to estimate the real-world effectiveness profile of Eliquis in Japanese Venous Thromboembolism patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are initiating Eliquis for the treatment of VTE or prevention of recurrent VTE for the first time

Exclusion Criteria:

* Prior treatment with Eliquis for nonvalvular atrial fibrillation or VTE
* Patients initiating Eliquis for the treatment of atrial fibrillation
* Off-label use of Eliquis

Other protocol defined inclusion/exclusion criteria could apply
Individual Differences in the Response to Drugs

The purpose of this study is to examine whether individual differences in acute responses to drugs co-vary across three drugs from different drug classes: alcohol, amphetamine and delta-9-tetrahydrocannabinol (THC). The investigators hypothesize that individuals who experience greater rewarding effects from one drug will also experience more rewarding effects from the other drugs.

Here, the investigators aim to investigate whether individuals exhibit similar responses to three different drugs from different classes. This study used a within-subjects design (total N = 24). All subjects received alcohol, amphetamine and delta-9-tetrahydrocannabinol (THC) in a double-blind, double-dummy fashion. Subjects completed six sessions wherein they received either alcohol, amphetamine, or THC, or corresponding placebos, on separate days. Subjects completed questionnaires about mood, general drug effects, and specific drug effects.

Eligibility Criteria:
Inclusion Criteria:

* English fluency
* High school education
* BMI between 19 and 26
* Individuals who report drinking at least 4 alcoholic drinks on one occasion in the past month

Exclusion Criteria:

* individuals with a medical condition contraindicating study participation, as determined by our physician
* individuals regularly using any contraindicated medications
* individuals with current dependence on any drug or past dependence on alcohol, marijuana or stimulants
* individuals with a past year DSM-IV Axis I mood, anxiety, eating, or psychotic disorder
* women who are pregnant, nursing, or planning to become pregnant in the next 3 months
* individuals who drink more than 10 alcoholic drinks per week
* individuals who currently use i) any illicit drug weekly or more frequently, ii) stimulant prescription drugs, iii) more than 10 cigarettes per week, and iv) more than 3 cups of coffee per day
Pharmacological Study of Cefazolin Antibioprophylaxis in Liver Transplantation

This study describes Cefazolin pharmacokinetics variation to target levels during liver transplantation.

Cefazolin is one of the many drugs used in antibiotic prophylaxis during liver transplantation. However there are no study describing its pharmacokinetics during liver transplantation.

Due to the severe pharmacokinetics interactions caused by both prior hepatopathy and surgical techniques we suppose that Cefazolin blood levels are very different from those targeted for antibiotic prophylaxis.

This study aim to describe pharmacokinetics of Cefazolin during liver transplantation in order to adapt antibiotic prophylaxis strategy in case of unadapted measured levels.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* patient undergoing liver transplantation
* receiving Cefazolin as perioperative antibiotic prophylaxis to prevent surgical site infections

Exclusion Criteria:

* pregnant women
* legal protection or protected adults
* ongoing antibiotic treatment before liver transplantation
* patient inability to receive information or express opposition to the study.
* patient refusing participation
A Phase 2 Extension of Study GCS-100-CS-4003

The primary objective of this study is to determine the safety and tolerability of extended dosing with a fixed dose of GCS-100 3 mg IV push in patients with Chronic Kidney Disease (CKD).

Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with adverse outcomes (de Boer et. al., 2011, Dang et. al., 2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). Animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney (Dang et. al., 2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). GCS-100 is a galectin-3 antagonist that has been shown to reduce fibrosis pre-clinically. Based on the role of galectin-3 and fibrosis in kidney disease, the Sponsor believes GCS-100 may be effective at treating patients with CKD.

This study will consist of a fixed dose of GCS-100 3mg IV push at least every 30 days for a total of 1 year with a follow-up 4 weeks after the last dose is administered.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent
2. Subject was enrolled in GCS-100-CS-4003.

Exclusion Criteria:

1. Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4003.
2. Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≥100 mmHg at screening
3. Subject has clinical laboratory values of:

   * Hemoglobin: ≤9 g/dL
   * Total bilirubin: \>1.5X the upper limit of normal (ULN)
   * ALT and/or AST: \>2.5X ULN
4. Subject has a concomitant disease or condition, including laboratory abnormalities, which, in the opinion of the investigator, could interfere with the conduct of the study or put the subject at unacceptable risk.
5. Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator.
Stage III Community-based Efficacy Trial for Mothering From the Inside Out

This is a Stage III community-based randomized clinical efficacy trial testing Mothering from the Inside Out (MIO), the first evidence-based parenting intervention designed to be delivered by addiction counselors in addiction treatment settings where parents of young children are enrolled in treatment.

This is a new Stage III community-based randomized clinical efficacy trial testing Mothering from the Inside Out (MIO), the first evidence-based parenting intervention designed to be delivered by addiction counselors in addiction treatment settings where parents of young children are enrolled in treatment. MIO is a weekly individual parenting therapy developed as an enhancement to standard addiction treatment that targets the addicted mother's capacity to recognize and regulate her own emotional distress during stressful parenting situations so that she can support her child's developing capacity for emotional and behavioral regulation. This capacity, called reflective functioning (RF), is a psychological skill that promotes abstinence and also helps parents foster their young children's secure attachment. Now that MIO has demonstrated efficacy in two randomized efficacy trials, the next step will be to conduct a new Stage III community-based efficacy trial where addiction counselors are trained to deliver MIO and PE with fidelity in an addiction treatment setting and to evaluate treatment outcomes and mechanisms of change in this community setting. At the end of this trial, if MIO demonstrates efficacy, all the necessary materials will be ready to train addiction counselors across a broad range of treatment settings in a Stage IV effectiveness trial. 120 mothers in addiction treatment and caring for children ages 11 - 60 months will be randomized to 12 sessions of MIO vs PE with a trained addiction counselor and fidelity will be monitored and maintained for treatment duration. It is expected that MIO-assigned mothers will demonstrate greater improvement in the primary targeted outcome - reflective functioning at week 12 (end of treatment) and week 33 (end of follow up). It is also predicted that MIO-assigned mothers will demonstrate greater improvement in secondary outcomes, including maternal sensitivity, caregiving behavior, psychiatric distress, depression and substance use at week 12 (end of treatment) and week 33 (end of follow up). Finally, it is predicted that children of MIO-assigned mothers will demonstrate greater improvement in the secondary outcome - attachment security - at week 12 (end of treatment) and week 33 (end of follow up).

Eligibility Criteria:
Inclusion Criteria:

* English-speaking female adults (18-65 years of age)
* Receiving outpatient substance abuse treatment services at the APT Foundation
* Caring for at least one child between 11 and 60 months of age
* Express interest in receiving assistance with parenting

Exclusion Criteria:

* Actively suicidal, homicidal, or severe cognitive impairment
Predicting Cerebrovascular Adverse Events Post Cardiac Surgery

The aims of this study are: i) to assess cerebral autoregulation and autonomic control within the different phases of cardiac surgery with cardiopulmonary bypass; ii) to compare cerebral autoregulation measures derived via cerebral blood flow velocity estimated by transcranial Doppler device with simpler measurements derived from near infrared spectroscopy; iii) to develop a predictive model of postoperative cerebrovascular outcome (overt or silent stroke) based on the extracted indices.


Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years
* spontaneous sinus rhythm
* no pregnancy
* signed informed consent

Exclusion Criteria:

* age lower than 18 years
* absence of sinus rhythm
* autonomic disorders
* concomitant carotid intervention
* reintervention
* contraindication to MRI
* pregnancy
* impossibility of informed consent
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders

This study aims to view variations in MRI measurements of the heart and the brain in people with anxiety versus healthy volunteers. The MRI measurements used will be Oxygenation-Sensitive Cardiac MRI (OS-CMR), a recent type of MRI which is safe, fast, and non-invasive.

The investigators will prospectively analyze OS-CMR data from patients with a generalized anxiety disorder from one site. The investigators will observe how an anxiety disorder affects the OS-CMR data. In a follow-up MRI scan, the investigators will look at the OS-CMR of a subgroup who have anxiety disorder and are also undertaking cognitive behavioural therapy to asses how and if this therapy affects the OS-CMR data.

Eligibility Criteria:
Inclusion Criteria:

Patient population:

Age 18-55,

* Confirmation of an anxiety disorder as identified by the PSWQ,
* No known, current or history, of significant medical conditions that may affect or directly involve the neurological, cardiovascular or respiratory system (except anxiety and depression)
* Non-smoker

Healthy Volunteers:

* Age 18-55
* No known, current or history, of significant medical conditions that may affect or directly involve the neurological, cardiovascular or respiratory system
* Non-smoker

Exclusion Criteria:

* General MRI contraindications: pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, pregnancy
* History of significant neurological disease or illness that is not anxiety (e.g. Dementia, stroke)
* Hemodynamically unstable conditions
* Significant or uncontrolled arrhythmias
* Severe pulmonary disease
* Recent (\<90 days) myocardial infarction
* Recent (\<90 days) surgery or coronary intervention
* Consumption of caffeine (caffeinated beverages, coffee, tea, cocoa, chocolate) within 12h of the exam
* Use of benzodiazepines or other short-acting anxiety medications (\<1 day)
Home-based tDCS for Prevention of Suicidal Ideation

Risk for suicide is elevated in the period after discharge from hospital among adults with major affective disorder. The primary objective of this study is to investigate the feasibility of delivering tDCS sessions for high-risk patients for suicide at home in the days following discharge from an emergency department or inpatient unit. This is a single-center, randomized, sham-controlled, double-blind clinical study. We plan to assess up to 80 adult patients for eligibility over 12 months of which 20 will be enrolled and randomized. Clinical assessments will be performed at baseline, post-treatment day 14 (14 days after the first tDCS session), and follow-up day 30 and 60 (30 and 60 days after the first tDCS session, respectively).


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 65 years
* diagnosis of mood or bipolar disorder registered in the electronic hospital medical record
* history of suicidal ideation and/or suicidal behavior at the time of admission registered in the electronic hospital medical record
* absent of suicidal ideation at the time of enrollment (defined as questions 1 and 2 of the C-SSRS answered "no")
* ability and willingness to provide information and permission to contact at least one person in the case of a need to contact them to promote subject safety or inability to reach the subject for follow-up
* a living situation with access to a private space suitable for the administration of the RS-tDCS sessions in the next three weeks
* agree to use a medically acceptable form of birth control while receiving the treatment if you are an individual able to become pregnant
* living in Monroe County region, as this is the area covered by the Mobile Crisis Team, a URMC psychiatric emergency team serving anyone within Monroe County
* device or computer with internet access for a URMC-approved remote RS-tDCS supervision
* ability to manage proper use of the device in a practice session

Exclusion Criteria:

* acute psychiatric instability or substance abuse (e.g., psychotic symptoms, alcohol misuse in the previous three months, use of any illicit drugs in the previous three months)
* unstable medical condition with reduction of functional capacity
* history of epilepsy or seizures in the last year
* history of neurodegenerative diseases registered in the electronic hospital medical record
* presence of or implanted any ferromagnetic metal in the head or the neck
* pregnant or breastfeeding or willingness to become pregnant in the next month
* history of head trauma (e.g., head injury, brain injury) or neurosurgery
* history of skin disorder or sensitive skin area near stimulation locations
* the presence of pacemaker
* current treatment with electroconvulsive therapy or transcranial magnetic stimulation
HNC: Human Neural Circuits Electrophysiology During Cognition

The purpose of this study is to understand how ketamine brings about dissociative symptoms.

The goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during antidepressant therapy and the side effect of dissociation. This research is designed to probe altered cognitive states associated with dissociation, depression, and other neuropsychiatric conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patient in clinical neuro inpatient units at Stanford Medical Center
* Age \>18 years old
* Female participants are expected to use an effective method of birth control throughout the study which includes: hormonal methods (birth control pills, patches, injections, vaginal ring or implants), barrier methods (condom or diaphragm) used with spermicide, intrauterine device (IUD), or abstinence (no sex)

Exclusion Criteria:

* Lifetime psychotic disorder
* Pregnant or nursing females
* Prior adverse ketamine response
* Use of ketamine in past 7 days
Comparison of Prosthetic Femoropopliteal Bypass Versus Viabahn Endoprosthesis for Treatment of Symptomatic Femoral Artery Occlusive Disease

This study is a comparison of two different ways to treat blockage in the artery of the thigh. The first is an older way with incisions in the groin and just above the knee. A plastic tube is then inserted to make a bypass from the groin to the knee. The second treatment offered is through a needle hole in the groin. A thin plastic tube covering a metal stent is inserted into the artery and released to bypass the blockage from inside the artery. No incisions are needed. Patients are enrolled and then selected for one treatment method or another by chance. The patients will be followed for two years to see how the two different treatment methods work compared to each other.


Eligibility Criteria:
Inclusion Criteria:Patients that had atherosclerotic stenotic or occlusive lesions of the superficial femoral artery with no significant aorto-iliac disease. The infra-popliteal segment had to be patent with at least single vessel run-off to the ankle. Patients had to be acceptable surgical candidates in the event they were randomized to the surgical arm.

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Exclusion Criteria:Non-operative candidate,Contraindication to IV contrast use, Planned surgery with venous conduit, previously stented segment of the superficial femoral artery, poorly compliant patient.

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Comparison of Pelvimetric Measurements Between MRI and Low-dose Stereoradiography (EOS® Imaging System)

The main objective of this study is to compare pelvimetric measurements performed by Magnetic Resonance Imaging (MRI) and by the EOS imaging system.

During pregnancy, after failure of External Manual Version (EMV) in case of breech fetal presentation, a radiological pelvimetry is performed to evaluate the measurements of the pelvis and decide on the appropriate mode of delivery.

Several imaging modalities are used, including pelvic computed tomography (CT),and magnetic resonance imaging (MRI) of the pelvis.

CT scan has the disadvantage of maternal irradiation and MRI has the disadvantage of an inaccurate morphological analysis.The EOS® system is an imaging tool used in radiopediatric to allow precise morphological analysis of bone masses with minimal irradiation.

The quality of the morphological analysis and measurements provided by the EOS® imaging system is the reason for proposing this study comparing the pelvimetric measurements obtained by MRI and by the EOS® imaging system.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years of age
* Patient requiring pelvimetry (breech fetus)
* Gestation \> 36 SA (weeks of amenorrhea)
* Patients with BMI \< 35
* Affiliated to social security or similarly regime
* Patients who gave their consent to participate in the study (Patient having agreed to perform both examinations: MRI and EOS system)

Exclusion Criteria:

* Patient with a contraindication to MRI (claustrophobia, pace-maker, intracorporeal metallic element)
* Patient with a contraindication to performing EOS® (person not standing alone)
* Patient who are in exlusion period of another interventiionnal study
* Person deprived of freedom by judicial or administrative decision; person hospitalized for psychitric care; person under legal protection measure.
Feasibility, Acceptability, and Preliminary Efficacy of a Mobile App (nOCD) for OCD

The purpose of this study is to evaluate the feasibility, acceptability, and potential usefulness of using a mobile application (nOCD) for treatment of obsessive compulsive disorder (OCD) in a sample of 25 adults (ages 18-65) in an 8 week trial. nOCD is a free iOS/Android application that provides treatment strategies. The study team will evaluate the effect of the application using gold-standard clinician-administered and self-report measures. Prior to downloading the application, participants will receive 4 (up to 5) in-person visit (orientation to the app and psychoeducation) and receive brief weekly phone check-ins. The long-term goal of this study is to use this information to develop new treatments for patients with OCD. All study procedures will be conducted on site at the New York State Psychiatric Institute.

The purpose of this study is to evaluate the feasibility, acceptability, and potential usefulness of using a mobile app (nOCD) for treatment of OCD in a sample of 25 adults (ages 18-65). nOCD is a free iOS/Android app that provides EX/RP-consistent treatment strategies. The study team will evaluate the effect of the app using gold-standard clinician-administered and self-report measures. Prior to downloading the app, participants will receive 4 (up to 5) in-person visits and receive brief weekly phone check-in. The long term goal of this line of research is to increase access to evidence-based treatment and to ultimately reach more patients giving them access to tools to reduce their OCD symptoms and improve their quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Primary DSM-5 diagnosis of obsessive-compulsive disorder
* Age 18-65
* Not currently receiving psychotherapy focused on OCD symptoms, and no EX/RP within the past 12 weeks
* For those currently on medication: On a stable dose of psychiatric medication (for at least 12 weeks)
* Capacity to provide informed consent

Exclusion Criteria:

* Comorbid psychiatric conditions that significantly elevate the risk of study participation (e.g. psychotic disorders, bipolar disorder, evidence of dementia or other cognitive disorder, suicidality).
A Study to Learn About the Safety of TALZENNA for the Treatment of Breast Cancer

The purpose of this study is to learn about the safety of TALZENNA for the patients with breast cancer that cannot be removed by surgery and has come back. These participants also have a past treatment with medicines that try to stop the growth of cancer cells.

This study is seeking for participants who:

* have breast cancer that cannot be removed by surgery and has come back
* have not used this medicine before. All patients in this study will receive TALZENNA according to the prescriptions.

Patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (Day 1). However, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with BRCA mutation-positive and HER2- negative unresectable or recurrent breast cancer with a history of cancer chemotherapy
* No history of previous use of this drug

Exclusion Criteria:

* None