cyrilzakka/clinical-trials huggingface dataset:
Oxytocin and Approach-avoid in Grief

This is a completed project which was initiated prior to January 18,2017

Background: Theoretical models of complicated grief (CG) suggest that maladaptive approach (e.g., perseverative proximity-seeking of the deceased) or avoidance (e.g., excessive avoidance of reminders) behaviors interfere with a person's ability to integrate the loss and recover from their loved one's death. Due in part to conflicting evidence, little mechanistic understanding of how these behaviors develop in grief exists. We sought to (1) identify behavioral differences between CG and non-CG groups based on implicit bias for grief-, deceased-, and social-related stimuli, and (2) test the role of the neuropeptide oxytocin in shaping approach/avoidance bias.

Methods: Widowed older adults with and without CG completed an approach/avoidance task measuring implicit bias for personalized, non-specific, grief-related, and other stimuli. In a double-blinded, randomized, counterbalanced design, each participant attended both an intranasal oxytocin session and a placebo session. Aims were to (1) identify differential effects of CG and stimulus type on implicit approach/avoidance bias \[placebo session\], and (2) investigate interactive effects of CG, stimulus type, and oxytocin vs. placebo on approach/avoidance bias \[both sessions\].


Eligibility Criteria:
Inclusion Criteria:

• Adult individual experiencing death of a spouse or partner between 6 and 36 months prior to enrollment

Exclusion Criteria:

* Inability to comprehend English;
* medical contraindications for other components of the study,
* active suicidality
* active homicidality
* active psychotic symptoms
* ongoing major health conditions such as cancer; uncontrolled hypertension; and medications likely to impact the oxytocin system (e.g., systemic corticosteroids).
* pregnant status or suspected pregnant status
* premenopausal status
Sleep Disordered Breathing in Acute Congestive Heart Failure

The goal of this study is to determine if sleep disordered breathing results in a measurable degree of overnight myocardial stress/injury in patients with acutely decompensated congestive heart failure. A secondary goal is to determine of a period of medical management attenuates this sleep disordered breathing-induced cardiac injury in this patient population.

Consecutive patients admitted to the hospital with acutely decompensated heart failure will be identified for potential enrollment in this study. Enrolled patients will first be asked to complete questionnaires to assess their symptoms and risk of having sleep apnea.

Relevant information will be obtained from the electronic medical record (age, gender, body mass index, co-morbidities, medications, prior echocardiography results). Subjects will then undergo a "type III" portable monitoring sleep study on the first or second night of their hospital admission, which measures respiratory effort, nasal airflow, oxyhemoglobin saturation, and heart rate. Blood samples will be collected on the evening before (08:00 PM +/- 2 hours), and the morning after (06:00 AM +/-2 hours) sleep apnea testing. If not otherwise obtained clinically, echocardiography will be obtained within 48 hours of admission. After a period of medical management for acutely decompensated heart failure, subjects will then have a second portable sleep apnea study (with associated pre and post-sleep blood draws) on the evening prior to discharge (approximately hospital day 5 or 6). Later, clinical outcomes such as incidence of renal dysfunction, hospital length of stay etc. will be collected from the electronic medical record. Blood samples will be processed, stored, and subsequently analyzed for high-sensitivity cardiac troponin T and I.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 18-80 years admitted to University of California San Diego La Jolla campus (Sulpizio Cardiovascular Center, Jacobs Medical Center, and Thornton Hospital) with acute decompensated heart failure will be identified in the emergency department, or upon admission to the cardiology or inpatient general medical services.

Exclusion Criteria:

* Known diagnosis of sleep disordered breathing and on treatment while hospitalized.
* Suspected acute coronary syndrome as determined by the primary clinical team.
* Intensive care unit level care.
* Requiring advanced heart failure therapy such as inotrope infusion, mechanical circulatory support etc.
* Intolerance of study procedures.
* Clinical attending physician refusal
Parabolic Flight Induced Neuroplasticity Studied With Advanced Magnetic Resonance Imaging Methods

Weightlessness profoundly modifies many physiological systems and especially the nervous system and the vestibular system. The changes in the nervous system are based in part on brain plasticity mechanisms, that is to say on modifications of neurons and their connections. They are the source of some of the behavioral response observed in the parabolic flight or in astronauts. For example, it is commonly observed that in the second and third days of parabolic flight campaigns with 3 flights, fewer participants are prone to motion sickness during the first day. Similarly, during their first trip into space, astronauts suffer 2/3 for 2 or 3 days of space sickness - special form of motion sickness - while this proportion is much lower in the second trip.

The hypothesis of this study is that short-term weightlessness as well as changes in the level of gravity experienced during parabolic flights, induce neuroplascity phenomena in brain regions involved in the integration of vestibular, visual and proprioceptive.

The goal is to objectify these plasticity phenomena, and assess their changes over time, using methods of Magnetic Resonance Imaging (MRI). A standard MRI will give an anatomical image of the brain. For this study, a variant called diffusion MRI (Diffusion Tensor Imaging - DTI) will visualize nerve bundles and their journey in the brain. The total duration of this review will be about ¾ hour.

The results of this study will be compared with those of an ongoing study of 12 astronauts who have the same MRI scans taken before and after a trip to the International Space Station. Investigators can then evaluate the effect of duration of exposure to weightlessness on the phenomena of neuroplasticity.


Eligibility Criteria:
Inclusion Criteria:

* • Healthy volunteers (men or women)

  * Aged from 21 to 65
  * Affiliated to a Social Security system and, for non-French resident, holding a European Health Insurance Card (EHIC)
  * Who accepted to take part in the study
  * Who have given their written stated consent
  * Who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude. There will be no additional test performed for subject selection.
  * Who has already been included in the Belgium part of this experiment and thus has signed the Belgium informed consent.

Exclusion Criteria:

* • Person who took part in a previous biomedical research protocol, of which exclusion period is not terminated

  * Person who has participated in a parabolic flight in the 2 previous years
  * Person with medical history of claustrophobia
  * Person with countraindication to MRI
  * Pregnant women
Risk Factors for Piperacillin/Tazobactam Resistance in Extended-Spectrum Beta-Lactamase (ESBL) Producing Organisms

This research will be conducted to determine whether risk factors exist for piperacillin/tazobactam resistance in ESBL organisms.

This is chart review at UPMC. NO human subject interaction will occur.

Eligibility Criteria:
Inclusion Criteria:

* Clinical information is collected by chart review of "case" and "control" patients.
* A "case A" patient is defined as follows: One or more clinical cultures are positive for an ESBL producing bacteria and the organism is piperacillin/tazobactam resistant.
* A "case B" patient is defined as follows: One or more clinical cultures are positive for an ESBL producing bacteria and the organism is piperacillin/tazobactam susceptible.
* Additionally, 1 control patient in the hospital at the same time as the case patients will be randomly selected for each case and are not in either case group.

Exclusion Criteria:

* Patients \< 18 years of age
The Advance Trial. Tongue Advancement for Obstructive Sleep Apnea: An Evaluation of the Aspire Medical Advance System

The objective of the study is to assess the effectiveness of the Aspire Medical Advance System in obstructive sleep apnea by demonstrating a statistically significant mean reduction in the apnea-hypopnea index (AHI) from baseline to 6 months, measured by polysomnography (PSG).

Obstructive sleep apnea (OSA) is a major health problem in the United States and can result in excessive daytime sleepiness and cardiovascular problems. The primary treatment for OSA today is continuous positive airway pressure (CPAP). Many patients however are unable to tolerate sleeping with a CPAP machine. Surgery is one of the main treatment options available today to these CPAP-intolerant patients. However, current methods of sleep surgery are painful, morbid, and/or lack decent effectiveness.

This trial will measure the effectiveness of the Advance System, an implantable medical device to treat OSA. In the trial, patients who meet the study entry criteria receive a baseline sleep study (PSG). The Advance System is then implanted and 6 months after implantation, another PSG is performed. The trial will compare the baseline and the 6 month apnea-hypopnea indices

Eligibility Criteria:
Inclusion Criteria:

* Previously diagnosed or screened with moderate to severe sleep apnea who have an AHI of between 15 and 60
* Age between 18 and 65
* Body mass index (BMI) \</= 32
* Patient has been offered CPAP and has refused or failed to continue CPAP treatment
* Identified evidence of airway collapse at the base of the tongue
* Signed informed consent

Exclusion Criteria:

* Prior OSA surgery except tonsillectomy, adenoidectomy, and nasal surgery
* Enlarged tonsils (3+ and 4+)
* Anatomy unable to accommodate the implant
* Severe mandibular deficiency/retrognathia
* Significant rhinitis/nasal obstruction
* Unable and/or not willing to comply with treatment follow-up requirements
* Pregnancy (female subjects of childbearing age mus have a negative pregnancy test prior to enrollment and should maintain adequate contraception during the study) or breastfeeding
* Active systemic infection
* Allergy to latex or any medication used during implantation
* Previous history of neck or upper respiratory tract cancer
* History of radiation therapy to neck or upper respiratory tract
* Dysphagia
* History of major cardiovascular disorders including MI, angina, uncontrolled hypertension, and CHF
* Major pulmonary disorders including COPD and uncontrolled asthma
* Patient is suffering from untreated/inadequately treated major depression, as determined by history
* History of falling asleep driving or motor vehicle accident secondary to excessive sleepiness
* Anesthesia risk group ASA Class IV or V
* Other medical, social or psychological problems that, in the opinion of the investigator, could complicate the procedure and/or recovery from this treatment or could complicate the procedures and evaluations pre- and post-treatment
* Enrollment in another pharmacological or medical device study
Determining the Impact of a New Physiotherapist-led Primary Care Model for Low Back Pain

This is a cluster randomized controlled trial to to evaluate the individual and health system impacts of implementing a new physiotherapist-led primary care model for back pain in Canada.

This study aims to evaluate the individual health outcomes and health system impacts of implementing a new physiotherapist-led primary care model for people with low back pain (LBP).

The overarching goal of this study is to determine the impact of integrating a physiotherapist (PT) within primary care teams for people with LBP and making them available to patients as the first point of contact. The specific aims of the research are to determine:

1. Whether a PT-led primary care model for LBP is effective at improving function (primary outcome), pain intensity, quality of life, global rating of change, and adverse events in comparison to usual physician led primary care.
2. The impact of a PT led primary care model for LBP on the healthcare system and society (healthcare access, primary care physician workload, healthcare utilization, missed work, and cost-effectiveness). A process evaluation will assess the healthcare delivered, potential mechanisms, context of implementation, and perspectives of patients and primary care providers towards the PT-led primary care model.

Eligibility Criteria:
Inclusion Criteria:

* Adults (19 years and over) with low back pain of any duration who are seeking primary care for back pain at a participating site (primary care visit may be a first or repeat visit).

Exclusion Criteria:

* Patients who do not consent to participation
* Patients who report being unable to understand, read, and write English
* Patients for whom the cause of their back pain is cancer
BLI (Blue Light Imaging) for the Histological Characterization of Colorectal Polyps

The accuracy of real-time histology prediction (hyperplastic vs. adenomas) of colonic polyps using white light high-definition endoscopes is suboptimal. Blue laser imaging (BLI) is a new system for image-enhanced endoscopy using laser light, that is incorporated in the last generation Fuji high- definition videocolonscopes ELUXEO. Blue laser imaging (BLI) utilizes two monochromatic lasers instead of xenon light: a 410 nm laser visualizes vascular microarchitecture, similar to narrow band imaging, and a 450 nm laser provides white light by excitation.This system should enhance the microvascular pattern of superficial lesions, making the histological prediction easier.

Aim of the study is to compare the accuracy of white light and BLI systems in real-time histology prediction of colonic polyps.

For this purpose all colonscopies will be performed in a standard fashion using white light. When a polyps \<10mm in size will be identified, patients will be randomized in two groups. In the Group 1 (White Light Grroup), all polyps \<10mm will be evaluated with white light and prediction of histology (hyperplastic versus adenomatous) will be made by means of white light. In the Group 2 (BLI Group) , all polyps \<10mm in size will be evaluated with BLI and scored as hyperplastic (type 1) or adenomatous (type 2) by applying the NICE (Narrow-band Imaging International Colorectal Endoscopic) classification, indicating color/vessel/surface pattern. The level of endoscopist's confidence in predicting histology (high or low confidence) for any polyp will be also recorded.

Diagnostic performances of the endoscopists (sensitivity, specificity, positive and negative predictive values) will be calculated comparing endoscopist's prediction and pathology report, considered as reference standard in both study groups in order to evaluate the accuracy of real-time histology prediction by using BLI or white light.


Eligibility Criteria:
Inclusion Criteria:

* All outpatients referred for colonoscopy

Exclusion Criteria:

* inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) \< 2 in one colonic segment)
* previous colonic resection
* inflammatory bowel disease
* ereditary polyposic syndromes
* patients on antithrombotics precluding polyp resection
* absence of informed consent
* inpatients or patients undergoing urgent colonscopy
Three Doses of Hepatitis A Vaccine in Patients With Immunomodulating Drugs

Hepatitis A vaccine is the most frequently used traveler's vaccine, yet data on its ability to induce protective immunity in immunosuppressed travelers are scarce. The investigators assess the hepatitis A virus (HAV) antibody response in patients with rheumatoid arthritis (RA) treated with Tumor Necrosis Factor (TNF) - inhibitors and/or methotrexate (Mtx).

In a previous study, 2 doses were not considered effective and there is therefore need for a study with an additional dose

Methods: Parameters registered at baseline were: age, sex, duration of disease, medications, activity of disease (Visual Analogue Scale), Health Assessment Questionnaire Disability Index, Disease Activity Score, Acute phase reactant and total immunoglobulin G in plasma). Hepatitis A vaccine (Epaxal or Havrix) were given at 0 and 6 months. Hepatitis A virus (HAV) antibodies is measured before vaccination and at month 1, 6 (before dose 2), 7 and 12 with quantitative HAV IgG, using the HAVAb-IgG Architect System, and by the HAVAB 2.0 assay on the AxSYM machine from Abbott. The level of protective immunity to HAV is defined as HAV IgG \> 10mIU/mL.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis
* TNF-alfa blocker and / or methotrexate in use as a medication against RA
* A desire to get protected against hepatitis A
* Men and women age 18-65 years
* Written informed consent
* Women of childbearing potential must use effective contraception -

Exclusion Criteria:

* Treatment with rituximab within 9 months before study start
* Known previous hepatitis A infection
* Previous vaccination against hepatitis A
* Allergy to eggs or formaldehyde
* Pregnancy or lactation
* Excessive use of alcohol
* Mental retardation
* Acute disease at the time of examination (fever \> 38 degrees)
* Volunteer works as an employee of the researchers
* Previous vaccination against hepatitis A
* Egg-, hen-protein- or formaldehyde allergy
* Pregnancy or lactation
* Excessive use of alcohol
* Another vaccine given within a month
* Acute disease at the time of examination (fever \> 38 degrees)
* Not suitable for other reason in the investigator's opinion (other serious disease, i.e. AIDS/HIV-positive, cancer with ongoing cytostatic treatment)
Prevention of Cardiovascular Diseases Caused by Complex Treatment of Patients With Primary Operated Breast Cancer

To develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications

Purpose of the study: to develop a method of medical prevention of cardiovascular diseases caused by cardiotoxicity against the background of complex treatment of patients with primary resectable breast cancer to reduce the risk of cardiovascular complications

Eligibility Criteria:
Inclusion Criteria:

* women with breast cancer, with a morphologically confirmed diagnosis before the appointment of anticancer therapy.

Exclusion Criteria:

* presence of other oncological diseases
Comparison of 24 Hour Bronchodilator Efficacy of Tiotropium 18 mcg Delivered Via DISCAIR Versus SPIRIVA 18 µg Delivered Via HANDIHALER® in Patients With Moderate to Severe COPD

The objective of this study is to compare the bronchodilator efficacy a of tiotropium inhalation via DISCAIR (18 mcg once daily) and SPIRIVA HANDIHALER® (18 mcg once daily) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40 years and older with moderate to severe COPD diagnosis
* Current/former smokers with at least a 10 pack-year history of cigarette smoking
* Patients with established clinical COPD and severity defined as a post-broncodilator FEV1/FVC ratio of ≤0.70 and FEV1 ≤80 % of predicted normal at screening
* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
* Have no excacerbation within last 4 weeks
* Hava capability of communicate with investigator
* Accept to adapt the procedures of study protocol
* Signed and dated informed consent

Exclusion Criteria:

* History of hypersensitivity to anticholinergics
* Diagnosis of asthma
* History of alergic rinit and athopy
* Current or history of lung cancer
* Known symptomatic prostatic hypertrophy requiring drug therapy
* Known narrow-angle glaucoma requiring drug therapy
* Have experienced exacerbation of COPD or lower respiratory inflammatory disease requiring use of antibiotics, oral or parenteral corticosteroids (CS) within 4 weeks prior to screening visit and/or during run-in period
* Patients vaccinated with poored virüs vaccinate within 2 weeks prior to screening visit and/or during run-in period
* Patients with a recent history of myocardial infarction, acute ischemic cardiac disease or severe cardiac arrhythmia requiring drug therapy
* Women who are pregnant or lactating or are planning on becoming pregnant during the study
The Relationship Between Urinary Incontinence and Motor Symptoms

There is no study in the literature examining the relationship between urinary incontinence and motor symptoms in individuals with stroke. The aim of this study is to determine the relationship between urinary incontinence and spasticity, balance and walking, which negatively affect quality of life and functional performance after stroke.

Evaluation parameters used in the study:

Modified Rankin Score 24 hours pad test Tinetti Balance and Gait Scale Modified Ashworth scale Danish Prostatic Symptom Score

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years old, having a stroke history of at least 3 months, having had only one stroke, scoring between 0-2 points according to MRS, being able to stand and walk independently or with a walking aid, being able to speak Turkish.

Exclusion Criteria:

* Those with incomprehensible speech disorders,
* Those who have additional neurological diseases other than stroke,
* orthopedic, cardiovascular, etc., which may cause balance disorders. those with illnesses,
* those who are pregnant,
* Those with vision and hearing loss
Virtual Reality (VR) Regulators

The purpose of this study is to test how well a virtual reality simulation helps adults learn new skills for managing children's emotions.


Eligibility Criteria:
Inclusion Criteria:

* Adult 18 years old or higher AND
* Caregiver of a child ages 3-6 years old OR educator or child allied health or medical professional that regularly works with children ages 3-6 years old

Exclusion Criteria:

* adults who do not speak English or Spanish
* adults with a history of significant motion sickness, active nausea, and vomiting or epilepsy
PoC in Rheumatoid Arthritis With Methotrexate

The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate


Eligibility Criteria:
Inclusion Criteria:

* Must have a diagnosis of RA for at least 6 months
* Must be taking methotrexate for at least 3 months \& on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
* Must have at least 6 swollen and at least 8 tender joints
* CRP above upper limit of normal or ESR \> 28 mm/hr
* Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication

Exclusion Criteria:

* Any infection including TB, HIV, Hepatitis B or C
* Recent infection requiring antibiotics within 4 weeks
* History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
* Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)