cyrilzakka/clinical-trials huggingface dataset:
Knowledge-based Iterative Model Reconstruction at Low-kilovoltage (kV) Cardiac Computed Tomography (CT)

The purpose of this study was to compare FBP-, hybrid IR-, and IMR techniques to assess their role in the identification of coronary artery disease and abnormalities in cardiac structures.


Eligibility Criteria:
Inclusion Criteria:

* A BMI of 27 kg/m2 or less and a coronary calcium score of less than 1,000 Agatston units.

Exclusion Criteria:

* BMI exceeded 27 kg/m2
* renal dysfunction (serum creatinine level \> 1.5 mg/dl)
* atrial fibrillation
* prior coronary artery bypass grafting
* heart failure (New York Heart Association class III-IV)
To Evaluate the Pharmacokinetic Interactions and Safety in Healthy Volunteers

To evaluate and compare the pharmacokinetic interactions and safety of multiple dose of Treatment A and Treatment B alone and in combination

The objective of this study was to evaluate pharmacokinetic characteristics and safety after oral concurrent administration of Treatment A and Treatment B compared to each single administration in Healthy volunteers.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, aged between 19 to 45 years (both inclusive) at the screening.
* Subjects who are informed of the investigational nature of this study, and voluntarily agree to participate in this study and signs informed consent

Exclusion Criteria:

* Subjects who have a clinically significant past or present medical history of hepato-biliary, renal, gastrointestinal, respiratory, hematologic/neoplastic, endocrine, urologic, psychiatric, musculoskeletal, immunologic, Otorhinolaryngological, and cardiovascular diseases.
* Subjects who have a medical history and/or condition that is considered to be dangerous to take the study drug.
Impact of Sunitinib Bioavailability on Toxicity and Treatment Efficacy in Patients Treated for Metastatic Renal Cancer

Patients treated on the first line of Sunitinib-targeted therapy for metastatic kidney cancer.

Collection of additional blood tubes during routine blood tests for patient follow-up, to evaluate the plasma concentration of Sunitinib and its active metabolite desethyl-Sunitinib (DES)


Eligibility Criteria:
Inclusion Criteria:

* Patient at least 18 years old
* Patient who read and understood the newsletter and signed the consent form
* Renal cell carcinoma histologically proven stage IV
* Metastatic stage proven on CT, synchronous or metachronous examination
* Patient operated on or not from the primary tumor
* Eligible for first-line systemic therapy with Sunitinib-targeted therapy for oncology urology
* Affiliation to a social security scheme
* Effective contraception (as defined by the WHO) for at least 3 months at the inclusion visit, during treatment and for 1 month after the end of the research (negative pregnancy test)
* Postmenopausal woman: confirmatory diagnosis (amenorrhea not clinically induced for more than 12 months at inclusion visit)
* General condition WHO 0 to 2
* Life expectancy estimated at more than 6 months at baseline

Exclusion Criteria:

* Non-metastatic disease
* Other cancer proven histologically, or in complete remission for less than 2 years
* Contraindication to SUTENT 50 mg hard capsules: Hypersensitivity to the active substance or to any of the excipients
* History of immunotherapy treatment for kidney cancer, previous treatment with targeted therapies for the same or previous cancer
* Pregnant or lactating woman or wishing to breastfeed within 6 months after the last treatment or no known contraception,
* Person deprived of liberty by an administrative or judicial decision or person placed under the protection of justice / sub-guardianship or curatorship
* Patient currently involved in an interventional trial
Comparative Study With Photodynamic Therapy And Triamcinolone Versus Photodynamic Therapy, Triamcinolone And Ranibizumab In Patients With Subfoveal Choroidal Neovascularization

The purpose of this study is to compare the efficacy of photodynamic therapy with verteporfin (PDT) and IVTA vs triple therapy (TT) in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

The investigators designed a prospective, comparative, randomized, double blind, controlled study. 15 patients with classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized. Triple therapy can potentially offer a new treatment modality for choroidal neovascularization in patients with macular degeneration and other diseases.

Purpose: To compare the efficacy of photodynamic therapy with verteporfin (PDT) and IVTA vs triple therapy (TT) in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Methods: Prospective, comparative, randomized, double blind, controlled study. 15 patients with classic subfoveal choroidal neovascularization secondary to age-related macular degeneration were randomized. Group 1: receive PDT followed by 4 mg IVTA (n=7) or group 2: TT (triple Therapy) PDT followed by 4 mg IVTA + 0.5 mg Ranibizumab (n=8).The main outcome measures were visual acuity (VA), mean change in lesion size, mean change in foveal thickness, retreatment rate and the incidence and severity of adverse events.

Results: At 6 months 5 of 7 patients (71.4%) of group 1 and 8 of 8 patients (100% ) of group 2 had lost fewer than 15 letters (P\<.001). Three patients (37.5%) of group 2 had an improvement of 3 lines or more. Lesion type, patient age, and lesion size had no influence on the outcome, but baseline VA had a statistically significant effect (P =.006). The median number of treatments in both groups was one. The 28% of PDT-triamcinolone group and 25% of triple therapy group had an increase in intraocular pressure (IOP) that required therapy. Progression or development of cataract was observed in 14.2 % in PDT- IVTA group and 12.5% in Triple therapy group. There were no cases of endophthalmitis. No cardiac or cerebrovascular accidents where presented.

Conclusions: The combination of PDT, intravitreal triamcinolone acetonide and intravitreal ranibizumab is a safe treatment option for neovascular AMD and prevents a considerable decrease in VA. In our patients it seems to be superior than combinated therapy with PDT and triamcinolone.

Clinical Relevance: Triple therapy can potentially offer a new treatment modality for choroidal neovascularization in patients with macular degeneration and other diseases.

:

Eligibility Criteria:
Inclusion Criteria:

* Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD)
* Any visual acuity

Exclusion Criteria:

* Previous treatment
* Glaucoma
Pravastatin and Protease Inhibitors in HIV-Infected Patients

To assess the use of pravastatin in hypercholesterolemic HIV-infected patients treated with protease inhibitors in a randomised double blind study.

Background. Highly Active AntiRetroviral Therapy including protease inhibitors is associated with elevated plasma lipid levels.

Design. randomized double-blind, multicentric.

Intervention. Pravastatin versus placebo for 12 weeks.

Eligibility criteria. Positive for anti-VIH antibodies, stable antiretroviral therapy including at least one PI for \>= 3 months, plasma HIV-RNA level of \< 50 copies/mL for \>= 3 months before randomization, total cholesterol \>= 5.5 mmol/L with LDL-cholesterol \>= 3.4 mmol/L on fasting status after three months of standardized dietary advice, written informed consent

Outcomes. HIV RNA at 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* confirmed HIV-1 infection (ELISA confirmed by Western-Blot test) ;
* Age above 18 years
* Stable antiretroviral therapy including at least one PI for \>= 3 months,
* Plasma HIV-RNA level of \< 50 copies/mL for \>= 3 months before randomization,
* Total cholesterol \> = 5.5 mmol/L with LDL-cholesterol \> = 3.4 mmol/L on fasting status after three months of standardized dietary advice,
* signed informed consent

Exclusion Criteria:

* Current AIDS event or infectious disease
* Tumoral, inflammatory, muscle diseases; kidney or hepatic failure
* Psychiatric conditions
* Biological elevated muscular enzymes
* Chronic alcohol consumption
* Pregnancy
Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence

The purpose of this study is to assess the effectiveness of an interactive, online safety decision aid among diverse Canadian women who are experiencing intimate partner violence (IPV). The investigators will also explore how the online intervention works, and whether it has different effects for different groups of women.

1 in 3 Canadian women experience IPV in their lifetimes. Over time, chronic stress of living in an abusive relationship has been shown to contribute to depression, anxiety and PTSD. Safety planning to reduce the risk of physical and emotional harm in abusive situations is one of the most widely recommended interventions for women in abusive relationship. However, fewer than 1 in 5 Canadian women access support from violence services to assist them in safety planning. Rural, Aboriginal, racialized, immigrant, sexual minority women and women who prioritize their privacy face particular barriers to accessing information and support for safety planning.

We adapted an interactive, online safety decision aid (SDA) recently developed and tested in the U.S. (Glass and colleagues, 2010) so that it applies to diverse groups of Canadian women, and extends the focus on emotional safety. The tool was revised based on a pilot testing for content and usability with 30 women (15 women who had experienced IPV and 15 service providers/experts). In this study, we test the effectiveness of this new tool, called "I CAN Plan 4 Safety" in a sample of 450 women from 3 provinces (ON, BC, New Brunswick). Women will be randomly assigned to complete either the personalized online safety decision aid (intervention) or an online tool which contains general risk and safety information (usual care control). Both tools are located on a confidential, password protected website. After initial completion of the online tools, they will be asked to login to the websites 3, 6 and 12 months later to complete standard outcome assessments. Women may access the information and resources in the online tools at any time for a 12 month period after they enrol in the study.

Eligibility Criteria:
Inclusion Criteria:

* Women
* 19 years and older,
* English-speaking,
* Living in Ontario, New Brunswick, or British Columbia,
* Reports current physical, sexual or emotional abuse in the context of coercive control from a current or former partner (boyfriend, girlfriend, husband, wife, or intimate/sexual partner)
* Expresses comfort with and access to a safe computer with internet
* Access to safe email and mailing address

Exclusion Criteria:

* Men
* Under 19 years of age
* Cannot read/speak English
* Living outside of the 3 study sites
* Uncomfortable using a computer or internet
* No access to a safe computer with internet
* No access to safe email and mailing address
* Does not report current violence from an intimate partner
Epinephrine in Irrigation Fluid for Visualization During Ankle Surgery

The purpose of this study is to evaluate the effect of epinephrine in irrigation fluid for visual clarity in ankle arthroscopic surgery.

The primary outcomes are:

* visual clarity during ankle arthroscopic surgery, which will be evaluated by visual analog scale from 0-10,
* and the intraoperative surgeon's discomfort related to bleeding, that will be measured by visual numeric rating scale from 0-3.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females ages over 18 years
* Patients who undergo ankle arthroscopic surgery
* Patients who are able to read and give informed consent on their own behalf

Exclusion Criteria:

* Patients with any known cardiac diseases
* Uncontrolled hypertension (\> 180/110 mmHg)
* Revision case
* Younger than 18 years of age
* Pregnant women
A Pilot Text Messaging Intervention to Reduce Smoking in Office-based Buprenorphine and Inpatient Detoxification Patients

The primary purpose of this study is to understand the feasibility of a text messaging intervention developed by the National Cancer Institute, known as Smokefreetxt, to improve smoking cessation among opiate and/or alcohol dependent participants discharged from an inpatient detoxification unit and enrolled in an office-based buprenorphine program patients (OBBP). Participants will be randomized to 1) treatment as usual (TAU) comprised of informational pamphlets and information for a 1800 quit line; and a prescription for a nicotine replacement therapy (NRT) (i.e. nicotine replacement patches based on the quantity of baseline self-reported smoking, or nicotine replacement gum (2mg) #10, for 28 days which is offered routinely to all inpatients at Bellevue at the time of discharge) versus the SmokeFreeTXT intervention plus prescriptions for NRT.


Eligibility Criteria:
Inclusion Criteria:

* self-described every or some day smoker
* diagnosed with opiate dependence and/or alcohol dependence (DSM-IV) per Physician medical records (MISYS)
* Fluency in English and able to provide a written informed consent
* Currently owning a mobile phone with a working phone number
* Expected to reside in the New York City area for the next 12 months
* Understands and able to respond to the intervention text message

Exclusion Criteria:

* inability to read or understand English
* currently using nicotine replacement therapies (patch, gum, e-cigarettes), pharmacotherapy for smoking cessation such as bupropion (zyban, wellbutrin), varenicline (Chantix).
* suicidal or homicidal ideations
* any ongoing psychotic disorder, life-threatening medical or psychiatric condition
* leaves the inpatient detoxification unit prior to completing study enrollment
* is pregnant, nursing or planning to conceive within the duration of the study period
The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now

In 2014, a team of parents, nurses, and physicians created Patient and Family Centered I-PASS (PFC I-PASS), a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. PFC I-PASS changed how doctors and nurses talk to patients and families on rounds when they're admitted to the hospital. (Rounds are when a team of doctors visit patients every morning to do a checkup and make a plan for the day.) Rounds used to happen in a way that left out patients and families. Doctors talked at, not with patients, used big words and medical talk, and left nurses out. PFC I-PASS changed rounds by including families and nurses, using simple non-medical words, and talking in an organized way so nothing is left out. When PFC I-PASS was put in place in 7 hospitals, patients had fewer adverse events and better hospital experience. But it didn't focus on how to talk with patients with language barriers. This project builds upon upon PFC I-PASS to make it better and focus on the special needs of patients who speak languages other than English. This new intervention is known as PFC I-PASS+. PFC I-PASS+ includes all parts of PFC I-PASS plus having interpreters on and after rounds and training doctors about communication and cultural humility. The study team will now conduct a stepped-wedge cluster randomized trial to compare the effectiveness of PFC I-PASS+ and PFC I-PASS to usual care at 8 hospitals.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the pediatric inpatient study units of participating hospitals
* Patients themselves who are age 13 and up (if they provide assent and their parent or guardian gives permission)\*
* Parents/caregivers of patients of all ages who speak English, Arabic, Armenian, Bengali, Chinese (Mandarin and Cantonese), Karen, Korean, Nepali, Quiche, Spanish, Somali, and Vietnamese (and/or other languages if resources allow)
* Nurses working on these units
* Residents working on these units
* Medical and nursing students working on these units
* Hospital leaders working at these hospitals
* \*Note for Consenting: Patients (13-18yo) who are in state custody and assent for themselves to complete surveys but lack legal guardian/caregiver present to offer consent are not being approached to complete surveys. These patients may still be enrolled in the study but not consented to complete patient-facing forms.

Exclusion Criteria: None
Multiple Ascending Dose Study of TD-0714 in Healthy and Elderly Subjects

Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy adult and elderly subjects


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
* Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
* Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
* Males must abstain from sex or use highly effective methods of birth control
* Negative for HIV, and Hepatitis A, B, and C

Exclusion Criteria:

* Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
* Subjects with a history of angioedema.
* Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
* Subject has acute illness (gastrointestinal, infection \[e.g., influenza\] or known inflammatory process)
* Subject bradycardia
* Subject has hypertension
* Subjects has orthostatic hypotension
* Subjects has orthostatic tachycardia
* Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.
* Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.
* Additional exclusion criteria apply
Anodal Transcranial Direct Current Stimulation (tDCS) in the Treatment of Tobacco Addiction

The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking and constitute a treatment of tobacco addiction.

Tobacco is estimated to cause more than 5 millions yearly deaths in the developed world. Although most smokers would like to quit, relapse rates remain high. It seems that this relapse is linked with the process of craving, which is a powerful desire to smoke elicited by smoking deprivation or exposure to situations or cues that are associated with smoking. Neuroimaging studies have shown that the dorsolateral prefrontal cortex (DLPFC), and especially the right part, is critically involved in processing the craving of smoking. Increasing the activity of the DLPFC by noninvasive brain stimulation has been demonstrated to be effective in decreasing craving symptoms in cigarette smokers.

The aim of this study is to determine whether a powerful technique of noninvasive brain stimulation, transcranial direct current stimulation (tDCS), could reduce cigarette smoking. tDCS is a painless and safe brain stimulation method capable of modulating cortical excitability. The nature of these modulations depends on stimulation polarity: anodal tDCS is thought to cause neuronal depolarisation and thus enhancing cortical excitability whereas cathodal stimulation is proposed to reduce excitability. The investigators hypothesize that anodal tDCS applied repetitively to the right DLPFC could constitute a treatment of tobacco addiction. Therefore, the investigators will conduct a sham-tDCS-controlled, randomized, double-blind study.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 55 years old
* Tobacco consumption from 10 to 25 cigarettes, for at least 1 year
* Strong tobacco dependence at the Fagerstrom Test (score \>= 5)
* Motivation to quit with a score \>=12 at the Motivation to Quit Smoking Scale (Q-MAT)
* Informed consent

Exclusion Criteria:

* Concomitant Axe I psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
* Other addictive disorder (DSM IV)
* No history of smoking cessation drug the previous year
* Psychotropic treatment
* Pregnancy or nursing
Quality of Life in Caregivers of Hospitalized Older Patients With Cancer

This clinical trial studies quality of life in caregivers of hospitalized older patients with cancer.

PRIMARY OBJECTIVES:

I. Identify patient and caregiver factors associated with increased caregiver burden and decreased quality of life in caregivers of older adults with cancer.

SECONDARY OBJECTIVES:

I. Determine characteristics of informal caregivers of older adults with cancer admitted to hospital.

II. Determine type and amount of care informal caregivers provide for older adults with cancer admitted to hospital.

III. Determine quality of life in informal caregivers of older adults with cancer admitted to hospital.

IV. Identify caregiver needs, both informational and resource related. V. Explore the association between re-admission to the hospital within 30 days and caregiver burden.

VI. Explore whether feedback of information attained from the assessment of the caregiver influences services implemented by the health care team.

VII. Determine reasons for non-participation.

OUTLINE:

Caregivers complete a questionnaire about their sociodemographics, physical health, social supports, social activity, mental health and caregiver burden. They will also provide an assessment of the person they care for.

Eligibility Criteria:
Inclusion Criteria:

* PATIENT: Age \>= 65 years old
* PATIENT: Diagnosis of cancer (solid or hematologic malignancy)
* PATIENT: Be able to provide informed consent
* PATIENT: Unplanned admission to hospital
* CAREGIVER: Primary caregiver (person who provides all of the majority of the unpaid care for the care recipient)
* CAREGIVER: Be able to provide informed consent

Exclusion Criteria:

* PATIENT: Planned admission to hospital for treatment (chemotherapy, transplant)
* CAREGIVER: Not fluent in English (because not all questionnaires have been validated in other languages)
* CAREGIVER: Paid and trained to care for the patient
Sonographic Predictors of Difficult Epidural Placement.

Epidural placement is a commonly used procedure for pain management during labor, delivery, and surgeries. However, epidural placement is often considered a technically challenging and complex procedure that requires a high level of skill and experience. In cases where the epidural is improperly placed or fails to produce effective analgesia, the discomfort and distress experienced by the patient may be heightened. Hence, the use of predictors, such as sonographic ones, may prove to be a valuable tool for healthcare professionals in the placement of epidurals, ultimately ensuring successful pain management for patients.

The present study aims to identify predictors of difficult epidural placement in patients undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

* Surgery with epidural placement
* Age \> 18 years

Exclusion Criteria:

* patient refusal