cyrilzakka/clinical-trials huggingface dataset:
Prospective Randomized Evaluation of an Ultra Conservative Approach to Implantable Defibrillator (ICD) Programming in Patients With a Left Ventricular Assist Device (LVAD).

We propose to study a strategy empirically applied for the past 6 months at a high volume LVAD center (Vanderbilt Heart and Vascular Institute). This utilizes an ultra conservative device programming strategy to maximize battery longevity, avoid inappropriate implantable cardioverter defibrillator (ICD) therapy, improve quality of life through reduction in overall shock burden, and potentially avoid unnecessary device generator changes prior to transplant. Avoiding CIED (cardiac implantable electronic device) change out device procedures prior to transplant is desirable.


Eligibility Criteria:
Inclusion:

* Age ≥ 18
* Advanced Heart Failure
* Scheduled for Heartmate II LVAD implant
* With existing ICD

Exclusion:

-Age \< 18
Prevent It 2.0/GPP -iCBT to Reduce the Risk of Committing Child Sexual Abuse

Child sexual abuse is a large-scale global problem, and with the internet and communication technologies enabling new ways to sexually abuse children, the problem is drastically increasing.

Prevent It is a free, anonymous, internet-delivered, therapist assisted, cognitive behavioral therapy (CBT) intervention for individuals concerned about their sexual urges or behaviors involving children. The treatment program is based on many years of clinical experience from working with this patient group, results from several previous research projects.

Using the scientifically rigorous design of a randomized controlled trial with waitlist control, we want to evaluate Prevent It 2.0 - an updated cognitive behavioral therapy treatment for individuals who are concerned about their sexual urges regarding children.

The study design is an academically initiated randomized controlled clinical trial where Prevent It 2.0 is compared with waitlist control. Participants in the waitlist control will wait thirteen weeks before starting active treatment. While on the waitlist, participants will respond to questions about ongoing problematic sexual behavior.

Recruitment will be carried out through multiple channels, and takes place on both "Darknet" and "Clearnet". All contact with participants, the treatment, evaluations, and termination of the contact, is conducted via the online treatment platform Iterapi, designed specifically for clinical trials of Internet-mediated CBT.

The treatment contains nine modules over thirteen weeks and the content of the therapy is classic CBT.


Eligibility Criteria:
Inclusion Criteria:

* concern about sexual urges regarding children
* Informed consent to participate

Exclusion Criteria:

* Participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse)
* Participants that are judged to have a limited understanding of the languages that the treatment is delivered in (English)
* Lack serious intention to participate (assessed by the researcher/therapist during the intake interview, which lasts approximately one hour)
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer

This trial studies how well high dose vitamin A compound works in treating participants with non-small cell lung cancer that can be removed by surgery. Vitamin A compound may increase the number of germinal centers (immune centers that make antibodies mature) in tumor and lymph tissues which may be beneficial to patients with cancer.

PRIMARY OBJECTIVES:

I. To compare the percentage of resected cancers containing germinal centers (GCs) in patients who receive neoadjuvant vitamin A compound (vitamin A) to controls.

SECONDARY OBJECTIVES:

I. To compare the abundance of GCs in adjacent lymph nodes in patients who receive neoadjuvant vitamin A to controls.

II. To compare histopathologic responses based on tumor necrosis in lung cancer patients who receive neoadjuvant vitamin A to controls.

III. To compare overall survival of patients who receive neoadjuvant vitamin A to controls.

EXPLORATORY OBJECTIVES:

I. To describe immunophenotypic changes of monocytes including myeloid derived suppressor cells (MDSCs) in pre- and post-treatment blood samples.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive vitamin A compound orally (PO) for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection.

GROUP II: Participants undergo surgical resection.

After completion of study treatment, participants are followed up for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older.
* Patients must have either biopsy proven or radiographically suspected non-small cell lung cancer.
* Patients must have disease in the chest that is felt to be surgically resectable.
* ECOG performance status of 0-2.
* Ability to understand and the willingness to sign an IRB-approved informed consent document

Exclusion Criteria:

* Patients younger than 18 years of age
* Women who are pregnant or breast feeding.
* Patients may not be receiving any other investigational agents for the treatment of nonsmall cell lung cancer.
* Patients may not be taking the following medications: high dose vitamin A supplement (multivitamin supplements prohibited only if vitamin A content is greater than 3,500 international units), bexarotene, alitretinoin, tretinoin, adapalene, isotretinoin, acitretin, doxycycline, minocycline, or demeclocycline,
* Uncontrolled intercurrent illness including, but not limited to, pancreatitis, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Hypervitaminosis A - toxic effects of ingesting too much vitamin A.
A Single Dose Study to Assess Adverse Events and How Oral Icalcaprant Moves Through the Body in Healthy Adult Japanese and Han Chinese Participants

This study will assess the pharmacokinetics, safety, and tolerability of icalcaprant administered orally in healthy adult Japanese and Han Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese or Han Chinese individuals.
* Japanese participants must be first or second-generation Japanese of full Japanese parentage. First-generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
* Han Chinese participants must be first or second-generation Han Chinese of full Chinese parentage. First-generation participants will have been born in China to two parents and four grandparents also born in China of full Han Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Han Chinese descent. Participants must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* History of epilepsy, seizure (except febrile seizure during childhood), unexplained alteration of consciousness, head injury with associated loss of consciousness, sleep disorder (except mild insomnia not requiring daily therapy), any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. - History of an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class.
* No use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
Food Effect Study of CTP-656 in Healthy Male Volunteers

Three way crossover study to assess the bioavailability of 656 under fed and fasted conditions.

This study will assess in healthy male subjects a solid oral dose formulation of CTP-656 under fasted and fed conditions.

Primary:

• To characterize the relative bioavailability and pharmacokinetic profile of a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.

Secondary:

* To characterize the pharmacokinetic profile of metabolites of CTP-656 following a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.
* To assess the safety and tolerability following a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between 18 and 50 years of age, inclusive
* Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening

Exclusion Criteria:

* History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) conditions
* PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug
* Liver function tests greater than the upper limit of normal.
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
* Urinalysis positive for greater than trace blood, protein or glucose
* A positive screen for alcohol, drugs of abuse, or tobacco use.
* Inability to comply with dietary restrictions during study participation.
* Donation or blood collection or acute loss of blood prior to screening.
Cytokine Expression in Psoriasis Patients with and Without Joint Involvement

The objective of the resarch is to study the cytokine profile of patients with psoriatic arthritis and psoriasis in order to better understand the pathophysiology of the disease and the contribution of cytokines to the presence or absence of joint involvement. This research will compare cytokines levels in sera, in PBMC culture after LPS or CD3/CD28 agonist antibodies, and in skin biopsy.

Psoriatic arthritis and Cutaneous Psoriasis are polygenic inflammatory disorders with high burden on the quality of life of patients. Pathophysiology of those disease remain incompletely understood. Recent publications seem to demonstrate an implication of IL-1 family cytokines in the pathogenesis of both diseases. In the literature, results are discordant and focus mainly on cytokines levels in serum of patients. Moreover, few studies compare psoriatic arthritis patients with cutaneous psoriasis patients. We propose here to study cytokines profiles of patients with those conditions in sera, after ex-vivo stimulation of peripheral blood mononuclear cells, and in skin biopsies.

Eligibility Criteria:
Inclusion criteria:

* For psoriasis patients :

  * Age over 18 years old
  * Signed informed consent
  * 5 year old psoriasis at least
  * At least one skin lesion over 2 cm
  * Without any articular symptoms
  * Without any DMARDs
  * Without anticoagulant treatments or coagulation disease
  * With normal articular and enthesis sonography
* For psoriatic arthritis patients :

  * Age over 18 years old
  * Signed informed consent
  * Psoriatic arthritis according to CASPAR criteria
  * Without any DMARDs
  * Without anticoagulant treatments or coagulation disease
  * With at least one synovitis at inclusion
* For controls

  * Age and sex matched with a patient without any rheumatic or dermatologic medical conditions
  * No treatment with corticosteroïds or non-steroïdial anti-inflammatory drugsAge over 18 years old

Exclusion criteria:

▪ For psoriasis patients :

* Joint damage according to CASPAR criteria
* Echography activity in favor of chronic inflammatory rheumatism
* For patients and controls:
* Without social protection rights
* People under judiciary protection, of less than 18 years old, pregnant woman, breast feeding women, jailed patients.
Diagnostic and Prognostic Value of Cardiac Biomarkers for Early Coronary Bypass Occlusion in Patients Undergoing Coronary Revascularization

This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.

The early diagnosis of the periprocedural myocardial infarction (MI) due to the bypass graft occlusion is an important element, in order to introduce early therapeutic strategies. Invasive coronary angiography (CA) is the gold standard to evaluate the postoperative myocardial ischemia due to the graft occlusion. Since this procedure has several important risks, such as thromboembolic events, dissection, bleeding, and contrast dye-induced nephropathy, in daily clinical practice, only patients with strong clinical suspicion of early MI following coronary artery bypass grafting (CABG) undergo this invasive procedure. There is a clinical need for the development of safe and accurate non-invasive diagnostic approaches to assess the early coronary bypass graft occlusion and to predict the consequent MI. A new clinical approach for the identification of the early post-procedural graft occlusion in patients undergoing CABG surgery is the high-sensitivity cardiac troponin (hs-cTn) cut-off level. The peri-operative bypass occlusion will be assessed by a Coronary Computed Tomography (CCT) scan which is a widely available non-invasive approach that permits an accurate evaluation of coronary stenosis. This study is to evaluate the correlation between hs-cTn level as cardiac biomarker for ischemia and early graft occlusion as assessed by CCT in patients undergoing coronary bypass surgery.

Eligibility Criteria:
Inclusion Criteria:

* patients with isolated coronary bypass surgery

Exclusion Criteria:

* Patients withholding or lacking informed consent
* Patients requiring a concomitant procedure
* Exclusion criteria concerning the CCT scan
* Patients with known allergy to iodine-containing contrast agents
* Renal function impairment (serum creatinine \>140 mmol/l; estimated glomerular filtration rate (GFR) \<30 ml/min/1.73 m2).
* Pregnancy
* Unstable clinical state or severe heart failure
* Patients with registered MI and registered bypass occlusion in coronary angiogram
* Patients that didn't undergo a CCT prior to discharge
Multi-centre Randomised Controlled Trial of Pelvic Floor Muscle Training for Prolapse

The aim of this study is to determine the effectiveness and cost-effectiveness of pelvic floor muscle training in the management of pelvic organ prolapse in women.

Pelvic organ prolapse is a common problem that adversely affects the daily activities and quality of life of many women. Pelvic floor muscle training interventions are commonly used by physiotherapists to manage prolapse. However, a Cochrane review found limited evidence to support the effectiveness of such interventions. Based on the findings of a successful feasibility study, this multi-centre randomised controlled trial will address the paucity of evidence. 556 symptomatic women with diagnosed prolapse will be enrolled in 16 UK centres and 1 New Zealand centre over 16 months and randomised to pelvic floor muscle training plus lifestyle advice, or to receive a lifestyle leaflet only. Principal measures of outcome are: prolapse symptoms, prolapse severity, and subsequent further treatment up to 12 months after trial entry.

Eligibility Criteria:
Inclusion Criteria:

* New attendee at outpatient gynaecology clinic
* Any type of prolapse

Exclusion Criteria:

* Stage 0 or IV prolapse
* Women reporting no symptoms of prolapse
* Previous treatment for prolapse (surgery or formal instruction in Pelvic Floor Muscle Training \[PMFT,\]unless completed more than 5 years ago, pessary, unless pessary removed more than 12 months ago)
* Unable to comply with PFMT
* women who have urogenital atrophy requiring treatment with local oestrogens (after an 8 week course of local oestrogen such women can be included);
* Pregnant or less than 6 months post-natal
* Unable to give informed consent
Prospective Data Analysis of a Quality Improvement Initiative in High Risk Cardiac Surgery Patients

This project is designed to assess the impact of implementing a hemodynamic optimization protocol, utilizing flow guided parameters that is provided by technology from Edwards Lifesciences, for patients undergoing high risk cardiac surgery. Importantly, this project is being targeted as a QI initiative because there is no evaluation of new technology or procedures. All technologies and procedures are currently being used for patients undergoing cardiac surgery. Rather this project is evaluating the implementation of a multi-dispclinary developed protocol that seeks to remove variability in which providers are currently treating patients hemodynamics during and acutely after cardiac surgery. Previous research has demonstrated that implementation of hemodynamic management protocols improves perioperative outcome in surgical patients. This project seeks to evaluate the impact of implementing this protocol as the new clinical standard for high-risk cardiac surgery patients. Specifically, this protocol would be a comprehensive hemodynamic management strategy that would-be initiated in the operating room post-bypass and then continued for the first 12 hours in the intensive care unit (see figure below). To restate, all technologies and procedures are currently being performed for these patients, however, there has not been a protocol guiding how practionioners use this technology. The project is evaluating the impact of protocolized treatment strategies. Importantly this protocol has been designed, reviewed and agreed by the motivation of the physicians who are currently responsible for managing these patients hemodynamics. Since this project does involve alterations in procedures or technologies we are seeking to proceed as a quality improvement project. Additionally the protocol is one that has been reviewed and agreed to provide the optimal management strategy for these patients. This again is the overall focus of this project, to implement a hemodynamic management protocol to improve outcomes in patients undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

(1) the procedure was a first-start case, (2) the procedure was scheduled, (3) the procedure is considered non-emergent, and (4) the cardiac surgery required cardiopulmonary bypass

Exclusion Criteria:

(1) Patients less than 18 years of age, (2) failure to undergo CPB, (3) non-first-start or emergent classification, (4) as well those who did not receive at least 12 hours of inotropic and/or vasoconstrictive agents were excluded from the study.
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic Patients

This placebo-controlled study will assess the safety and efficacy of a 90-day course of treatment with ifetroban for portal hypertension in cirrhotic patients


Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis
* baseline hepatic venous pressure gradient (HVPG) \>= 8 mmHg and \<= 18 mmHg
* stable liver function enzymes

Exclusion Criteria:

* portal or splenic vein thrombosis
* Transjugular intrahepatic portosystemic shunt (TIPS) or portocaval shunt
* variceal bleed in last 2 months
* hemodialysis
* Child-Pugh Score \>= 12
* Model for End-stage Liver Disease- Sodium score (MELD-Na) \>= 20
* Acute kidney injury, Chronic kidney disease and/or Serum Creatinine \>= 2.0 mg/dL
* current alcohol consumption \> 2 drinks per day
* Platelet count (PLT) \< 60 x 10\^3/microliter (uL)
* A change in statin therapy in the last 3 months
* Current Hepatitis Virus B or C (HBV or HCV) therapy; or planned initiation of therapy during the treatment period
* Myocardial infarction within 30 days
* History of bleeding diathesis or current (within previous 14 days) or planned use of anticoagulant or antiplatelet drugs including aspirin
The Use of Constant-flow Technique for Determining the Lower Inflexion Point of Pressure-volume Curve and Intrinsic PEEP During One-lung Ventilation

One method for treating intraoperative hypoxia during one-lung ventilation (OLV) is application of PEEP to the dependent lung. However, only a minority of patients benefit from this maneuver. The effect of applied PEEP on oxygenation depends on the relation between the total end-expiratory pressure and the lower inflexion point (LIP) of pressure-volume curve (1). LIP during OLV can be determined with super-syringe technique, but is too complicated for routine operating room use. An alternative is the constant-flow method which is easy and widely used in intensive care settings (2). The investigators goal was to confirm that the constant-flow method as applied by an intensive care ventilator works during OLV.

Methods: After IRB approval and written, informed consent, data were obtained from 20 patients during OLV for thoracic surgery who were ventilated with an AVEA (VIASYS Healthcare) critical-care ventilator. During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used. During OLV, ventilation periods of ten minutes, with and without 5 cmH2O PEEP were alternated. During each period, the investigators recorded arterial blood partial pressures, respiratory and hemodynamic values, intrinsic PEEP (PEEPi), and LIP. PEEPi and LIP were determined using the automatic mode of the ventilator; specifically, LIP was determined with a continuous flow of 3L/minute.


Eligibility Criteria:
Inclusion Criteria:

* thoracic surgery lung ventillation