cyrilzakka/clinical-trials huggingface dataset:
A fMRI Study of the Treatment of Danish Veterans With PTSD With Prolonged Exposure Therapy

In this article, the investigators report the design and protocol of a functional magnetic resonance imaging study (fMRI) of the treatment of Danish veterans with PTSD with Prolonged Exposure Therapy (PE). In total 30 Danish veterans will be recruited, who meet the ICD-10 diagnostic criteria for PTSD, and treated with PE. A group of controls will be recruited consisting of age-appropriate same sex veterans who have participated in international missions similar to the patient group

Primary outcome measures are the changes in d2-test assessment of attention and concentration, Beck Depression Inventory, Post-traumatic Symptom Scale-Interview version and PTSD Checklist- Military Version.

Secondary outcome measures concern changes of Brain Derived Neurotrophic Factor (BNDF) and changes in the brain structure with focus on the hippocampal function using fMRI.

Eligibility Criteria:
Inclusion Criteria:

* Cases: Danish veterans with ICD-10 diagnostic criteria for PTSD
* Controls: Danish veterans without ICD-10 diagnostic criteria for PTSD

Exclusion Criteria:

* Participants who have an active abuse of psychoactive substances with daily consumption.
* Participants who consume more than 21 units of alcohol per week, and who, during the last month, have had repetitive episodes with craving, episodes of loss of control due to alcohol consumption, and a weakened ability to manage consumption, stop or reduce consumption
* Participants who have a current ICD-10 diagnosis within:

  * F20 to F29 Schizophrenia
  * Schizotypical mental disorder
  * Delusional disorder
  * Acute and transient psychotic disorders and Schizoaffective psychosis
  * F30 Manic single episode
  * F31 Bipolar affective disorder
  * F60.2 Dyssocial personality structure
  * F60.3 Emotionally unstable personality structure
  * F90 Hyperkinetic disorder (ADHD) F98.8 Other behavioural and emotional disorders in childhood and adolescence (ADD)
* Participants who have a daily intake of sedative, anxiolytic
* Participants who score below 23 on the Mini Mental State Examination, and (5)
* Participants who within the last 3 months have had a serious suicide attempt.
* Exclusion criteria related to the fMRI scanning include:

  * Ferromagnetic prostheses (including straps prostheses, clips on blood vessels, pacemakers, and metal splinters)
  * claustrophobia and movements during the scan.
Enhancing Coping Skills in Patients With Cancer

* Approximately 30% of all patients with cancer report levels of psychological distress indicative of the need for psychological intervention.
* Research suggests that learning more adaptive coping strategies improves psychological adjustment to cancer.
* It is imperative to develop cost-efficient, feasible psychosocial interventions.
* The aim is to test the efficacy of the self administered format of a psycho-educational intervention (NUCARE) in reducing distress and enhancing adaptive coping strategies for cancer patients.

It is hypothesized that:

* patients would show significant reductions in distress (i.e., depression and anxiety) over the 6-week treatment period, and that treatment would produce superior results compared to wait-list; patients would maintain or even increase their improvement up to 3 months following treatment.
* the treatment would enhance more adaptive coping strategies.
* greater self-reported adherence to the treatment/homework would be associated with symptom improvement, more autonomous self-regulation and higher perceived competence for adhering to the coping intervention program.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years of age,
* able to read English,
* a cancer patient presenting at the McGill University Health Centre (MUHC) interested in participating,
* willing to receive minimal therapist contact (by telephone) and self administered therapy,
* able to give their own consent.

Exclusion Criteria:

* currently receiving psychological/psychiatric treatment/counselling,
* indicate at the time of recruitment that they intend to seek psychological treatment elsewhere during the study period,
* a history of psychosis or bipolar disorder,
* substance abuse/dependence in last 6 months,
* taking psychotropic medication with altering dosages in the past 3 months.
Feasibility and Acceptability of a Remote Glucose Monitoring Program for Pregnant Marshallese Women

The overall objective is to test the feasibility and acceptability of a remote glucose monitoring program among Marshallese women with PGDM (pre-gestational diabetes mellitus) or GDM (gestational diabetes mellitus) and with limited English proficiency.

iGlucose Remote Monitoring System. iGlucose is a remote patient monitoring system. The iGlucose monitor works by analyzing a small amount of blood placed on a strip that is inserted into the monitor, similar to a standard glucometer. The iGlucose monitor will show the patient their glucose reading and will automatically send the patient's glucose reading to a database via cellular networks when the patient removes the strip from the device. The iGlucose monitor does not require any recording on the part of the patient. The iGlucose data is managed through a HIPAA-compliant Amazon Web Services (AWS) database maintained by Smartmeter. The data is available to the provider to monitor the patient's blood glucose levels accurately and in a timely manner, allowing for treatment to be adjusted. The data is available for the physician during every patient contact for review and discussion.

Patients will be provided with the iGlucose monitor at the baseline data collection. A trained bilingual research assistant will review the iGlucose guide with the participant, provide training on the use of the monitor, taking a blood glucose reading with the monitor, and the patient will use the iGlucose monitor once in front of the research assistant. The patient will receive a packet of information in their language of choice (English and/or Marshallese). The packet will include information on how to use the monitor (including the iGlucose Guide) and contact information if there are any problems with the monitor during the study. The patient will use the monitor as instructed by their healthcare team to monitor their blood glucose. The patient will return the equipment at the completion of the study.

The participant will provide their physician's information as part of the study, so that the investigators may provide access to the iGlucose blood glucose readings through the electronic guidebook and contact the physician post-intervention to complete a survey.

Eligibility Criteria:
Inclusion Criteria:

* Women who self-identify as Marshallese
* 18 years of age or older
* ≤30 weeks pregnant
* Receive prenatal care at University of Arkansas for Medical Sciences (UAMS) and partner clinics and hospitals
* Have used a paper log for at least two weeks
* Have a diagnosis of PGDM (pre-gestational diabetes mellitus) or GDM (gestational diabetes mellitus).

Exclusion Criteria:

* Women who are unable to use a glucometer by themselves
* Have not used a paper log
* Have a continuous glucose monitor
* More than 30 weeks pregnant
Reproductive Hormonal Alterations in Obesity

The purpose of this study is to determine why obese women have lower hormone levels and less fertility than women of normal body weight. The proposal will examine the reproductive system at the level of the brain and the ovary to define the changes that happen leading to lowered hormone production. Women will be studied throughout a menstrual cycle and given medications that will test how well their pituitary gland can make hormones that stimulate the ovary (luteinizing hormone (LH) and follicle stimulating hormone (FSH)). They will also be given a medication to abolish estrogen production in the body and their response to this medication will be assessed. Finally, the ovary's ability to produce progesterone after ovulation will be examined.

--Hypotheses:

1. Obese women have reduced pituitary sensitivity to exogenous gonadotropin-releasing hormone (GnRH), but normal clearance of exogenous LH. (comparative study of obese compared to normal weight women)
2. Obese women have abnormally increased sensitivity to estradiol negative feedback which will be reversed by an aromatase inhibitor. (comparative study of obese compared to normal weight women)

AIM 1: test the hypothesis that reduced pituitary sensitivity to GnRH-induced LH and FSH secretion causes the relative hypogonadotropic hypogonadism of obesity AIM 2: test the hypothesis that the hypothalamic-pituitary axis is abnormally sensitive to estradiol negative feedback in obesity

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40 at study entry
* BMI either 18-25 kg/m2 or ≥30 kg/m2
* prolactin (PRL) and thyroid-stimulating hormone (TSH) within normal laboratory ranges at screening
* Baseline hemoglobin \>11 gm/dl
* History of regular menstrual cycles every 25-35 days if BMI 18-25 kg/m2
* History of regular menstrual cycles every 25-40 days if BMI ≥30 kg/m2

Exclusion Criteria:

* History of chronic disease affecting hormone production, metabolism or clearance
* Use of medications that are known to alter or interact with reproductive hormones (e.g., thiazolidinediones, metformin)
* Use of hormones within three months of enrollment
* Excessive exercise (\>4 hours per week)
* Pregnancy, breast-feeding or current active attempts to conceive
A Study for Participants With Metastatic Renal Cell Carcinoma

This study will compare the effects of Enzastaurin plus Sunitinib versus Sunitinib alone in metastatic Renal Cell Cancer.

This is a multicenter, Phase 2 study of enzastaurin and sunitinib versus placebo and sunitinib as first-line therapy in participants with metastatic renal cell carcinoma, containing 2 parts. Part 1 is a safety lead-in study with 12 participants and possible dose escalation. Part 2 is a randomized, double-blind, Phase 2 study in 110 participants.

Eligibility Criteria:
Inclusion Criteria:

* Participants with metastatic Renal Cell Carcinoma (RCC) who have not received prior treatment with systemic (adjuvant or neoadjuvant) therapy for RCC (including targeted therapy such as tyrosine kinase inhibitors or bevacizumab, immunotherapy, chemotherapy, hormonal, or investigational therapy)
* Histologically confirmed RCC with metastases with a component of clear (conventional) cell histology
* Evidence of unidimensional measurable disease, measured by computed tomography (CT) scan or magnetic resonance imaging (MRI)
* Primary tumor has been surgically removed by nephrectomy or nephron-sparing surgery
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Participants must sign an informed consent document

Exclusion Criteria:

* Have received prior treatment with sunitinib or enzastaurin
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
* Have had any of the following within 12 months prior to study drug administration:

  * myocardial infarction,
  * severe/unstable angina,
  * coronary/peripheral artery bypass graft,
  * symptomatic congestive heart failure (CHF),
  * cerebrovascular accident,
  * transient ischemic attack, or
  * pulmonary embolism
* Note: Ongoing treatment with therapeutic doses of Coumadin® (warfarin) or a derivative of Coumadin or phenprocoumon is not allowed, but prophylactic, low-dose Coumadin (≤ 2 mg daily) for deep vein thrombosis is allowed. In such cases, prothrombin time/international normalization ratio (PT/INR) should be very closely monitored as clinically indicated
* Ongoing cardiac arrhythmias \>New York Health Association Class II, atrial fibrillation of any grade, or prolongation of the QTc interval to \>450 millisecond (msec) for males or \>470 msec for females.
* Have uncontrolled hypertension \[\>150/100 millimeter of mercury (mm/Hg) despite optimal medical therapy\], or history of poor compliance with antihypertensive treatment
* Require concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inducer, for example, rifampicin or potent CYP3A inhibitors, such as ketoconazole.
* Significant surgery or radiation therapy \<4 weeks of starting study treatment. Prior palliative radiotherapy to metastatic lesion(s) is/are permitted, provided there is at least 1 measurable lesion that has not been irradiated
* Participants who are pregnant or breast feeding
QuickOptTM Study - Using the QuickOptTM Method for Timing Cycle Optimization

QuickOptTM optimization method provides a quicker, simpler and reliable alternative to standard echocardiography methods for optimization of sensed AV, paced AV and V-V delays in patients with CRT-P devices


Eligibility Criteria:
Inclusion Criteria:

* Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system
* Patient is able to provide written informed consent for study participation

Exclusion Criteria:

* Patient has limited intrinsic atrial activity (≤ 40 bpm)
* Patient has persistent or permanent AF
* Patient has a 2o or 3o heart block
* Patient is unable to provide analyzable echocardiogram images
* Patient's life expectancy is \<12 months
* Patient is \<18 years old
* Patient is pregnant
* Patient is on IV inotropic agents
Consequences of Human Inactivity

Epidemiological studies as well as both longitudinal animal and human inactivity studies indicate that low physical activity is associated with the pathophysiology of type 2 diabetes mellitus (T2DM) and obesity, and recently it has been estimated that physical inactivity (worldwide) causes 7% of the burden of disease related to e.g. T2DM. Physical inactivity, a high energy dietary intake, and T2DM are also associated with dementia, depression, and impaired cognitive function. It is critical that we understand how inactivity alters body composition, glucose and lipid metabolism, and cognitive function, if normal physical activity can prevent these changes, and if there are any differences between sexes.

The present protocol is divided in several in several sub-studies:

1. To test whether and how a physically inactive lifestyle will influence body composition, glucose and lipid metabolism, and cognitive function.
2. To test whether normal physical activity can prevent the deleterious effect of a physically inactive lifestyle despite a high-caloric intake.
3. To test whether the influence of a physically inactive lifestyle combined with a high-caloric intake differs between sexes.


Eligibility Criteria:
Inclusion Criteria:

* Normal physical active
* Healthy
* 18-40 y of age
* Non-smokers

Exclusion Criteria:

* Pregnancy
* Diabetes in family
Screening of Specific Genes for Pigmented Villous Nodular Synovitis

This study retrospectively analyzed the history of present illness of PVNS patients in our hospital. The enrolled patients were followed up by telephone to follow up their postoperative recovery and living conditions. Take the patient's pathological specimens for immunohistochemical testing, evaluate the relationship between the expression of different molecular targets, clinical manifestations and patient prognosis, and explore new molecular targets related to disease diagnosis and treatment.

This study retrospectively analyzed the symptoms, time of onset, injury history, laboratory examinations, imaging examinations, and intraoperative conditions of PVNS patients in our hospital. The enrolled patients were followed up by telephone to follow up their postoperative recovery and living conditions (VAS score, SF-36 score). Take the patient's pathological specimens for immunohistochemical testing, evaluate the relationship between the expression of different molecular targets, clinical manifestations and patient prognosis, and explore new molecular targets related to disease diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of pigmented villonodular synovitis.
2. Clinical diagnosis of giant cell tumor of tendon sheath

Exclusion Criteria:

1. No surgical treatment.
2. There were no pathological specimens during the operation.
3. The age of the patient is less than 18 years old or more than 60 years old.
4. The operation record shows nodular type.
A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump

This trial is conducted in the United States of America (USA). This is an in-patient trial investigating stepwise dose increase in a period of up to 3-weeks followed by a 10-week out-patient maintenance period. A telephone contact visit is scheduled as a follow-up for the final clinic visit. A subject's participation in this trial would be expected to be up to 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes diagnosis at least 2 years ago
* Body Mass Index (BMI): 26-40 kg/m\^2 (both inclusive)
* HbA1c: 7.5-10% (both inclusive)
* FPG values at least 140 mg/dl (7.8 mmol/l)

Exclusion Criteria:

* Use of drugs, which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action or glucose utilization (steroids or non-specific beta-blockers)
* Current addiction to alcohol or substances of abuse or positive results on urine screen for drug and alcohol use
* Known or suspected allergy to trial products or related products
A Study to Evaluate the Impact on Skin (Injection Site) Reactions of Taking an Antihistamine (Zyrtec®) or Placebo Prior to Daily Injections of Copaxone®.

This study is designed to compare injection skin (injection site) reactions when an antihistamine (Zyrtec®) or placebo is taken prior to performing daily Copaxone® injections. Patients will be assigned (like a flip of a coin) to take either a placebo or an antihistamine (Zyrtec®) prior to performing their daily Copaxone® injections. The patient and physician will be unaware whether they are taking a placebo or antihistamine during the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years of age or older
* Diagnosis of RRMS
* Beginning or recently (within \< 3months) began self-injecting Copaxone®

Exclusion Criteria:

* Taking any other immunomodulatory therapy in conjunction with Copaxone®
* Unable to perform subcutaneous self-injection
* Pregnant or trying to become pregnant, or breast feeding during the study
* Previously participated in this study or in another clinical trial in the past 30 days
Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study

The aim of the study is to assess visual function from neonatal age to 36 months of age in infants at risk of visual impairment due to brain lesion or ocular pathology


Eligibility Criteria:
Inclusion Criteria:

* Age between 34 weeks of post-menstrual age and 36 months of life in children born before 37 weeks gestational age
* Genetic syndroms
* Hypoxic Hischemic Encephalopathy
* Brain malformation
* Metabolic diseases
* Ocular pathologies

Exclusion Criteria:

* Patients at low risk of developing neurological outcomes
* Refusal of informed consent
Anesthetic Depth and Postoperative Delirium Trial - 2

Recent limited evidence suggests that anesthetic depth may influence postoperative cognitive outcomes, however, the mechanism between this association is unclear.

Recently, it has been proposed that use of a processed electroencephalogram (EEG) monitor during surgery may be associated with a lower rate of postoperative delirium. In fact, some suggest that older patients undergoing surgery should routinely be monitored with an anesthetic depth monitor to allow the titration of anesthetics or sedation medications to lighter levels to promote better postoperative cognitive outcomes. Recent studies, including preliminary results from our group, have demonstrated electroencephalogram (EEG) suppression to be an independent risk factor for postoperative delirium.

Prior studies that have focused on risk prediction have shown age and prior cognitive impairment to be the most consistent risk factors for postoperative delirium. However, as of yet, no clinical trial has identified a relationship whether use of processed EEG monitor resulted in a reduction of incident postoperative delirium through a reduction in EEG suppression, with proper consideration of patients' baseline cognitive status as a potential moderator. Additionally, use of anesthetic depth monitor to keep patients' anesthetic depth above a specified value has never been validated or proven to be feasible or safe.

Accordingly, the investigators plan an exploratory study to: 1) determine whether the use of processed EEG to keep anesthetic depth above a specified level, results in a reduction in EEG suppression when compared to standard anesthetic care, 2) to determine whether preoperative level of cognitive function moderates the effect of group assignment on EEG suppression, and 3) to determine the feasibility and safety of using processed EEG-guided to keep patients' anesthetic depth above a specified value. A secondary aim was to determine the effect size for the intervention to reduce postoperative delirium for subjects with and without preoperative cognitive impairment for a future trial.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older of age undergoing non-cardiac surgery, requiring hospital stay of 2 or more days.

Exclusion Criteria:

* patients who are not fluent in English or cannot provide informed consent
* patients who may not tolerate either light or deep anesthesia (history of heart failure, coronary artery disease, substance abuse)
* history of intraoperative recall or awareness during anesthesia
* pathologies of the brain which may affect EEG monitoring
* patients who are anticipated to have consecutive surgery within 3 days of first procedure
* patients who have had surgery with general anesthesia in the past 30 days
Characterization of New Human Models of Non-histaminergic Itch

In this experiment the investigators would like to test a new new human itch model based on papain, and to characterize the sensory quality and temporary aspects of papain skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.

The most used model of non-histaminergic itch is cowhage but this models presents several problems, such us the impossibility of standardizing the amount of the spicules inserted in the skin and the difficulty of obtaining the substance. These aspects bring us the necessity to find a new and more standardized model of non-histaminergic itch.

Papain is a cysteine protease extracted from papaya plant that is known to cause itch if applied to the skin. For these reasons the investigators would like to test a new new human itch model based on papain, and to characterize the sensory quality and temporary aspects of papain skin prick test (SPT) in comparison to the inactivated-cowhage delivery system.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* 18-60 years
* Speak and understand English

Exclusion Criteria:

* Pregnancy or lactation
* Drug addiction defined as any use of cannabis, opioids or other addictive drugs
* Previous or current history of neurological, dermatological, immunological musculoskeletal, cardiac disorder or mental illnesses that may affect the results (e.g. neuropathy, muscular pain in the upper extremities, etc.).
* Lack of ability to cooperate
* Current use of medications that may affect the trial such as antihistamines, antipsychotics and pain killers, as well as systemic or topical steroids.
* Skin diseases
* Moles, scars or tattoos in the area to be treated or tested.
* Hypersensitivity to papaya and mango fruit, cashew nuts, rubber latex
* Consumption of alcohol or painkillers 24 hours before the study days and between these
* Acute or chronic pain
* Participation in other trials within 1 week of study entry (4 weeks in the case of pharmaceutical trials)