cyrilzakka/clinical-trials huggingface dataset:
Acceptance and Commitment Therapy (ACT) for OEF/OIF Veterans

This trial compares two psychotherapies, Acceptance and Commitment Therapy (ACT) and Present Centered Therapy (PCT), for veterans of the conflicts in Iraq and Afghanistan. We hypothesize that ACT will be more effective than PCT at reducing emotional distress and improving functioning. We further hypothesize that both interventions will be highly acceptable to participants.

The proposed study is a randomized controlled trial (RCT) of Acceptance and Commitment Therapy (ACT) as compared to a control psychotherapy, Present Centered Therapy (PCT), for individuals with distress and impairment who deployed as part of Operation Enduring Freedom and/or Operation Iraqi Freedom (OEF/OIF). ACT was selected for study because it has a number of advantages for this population. It is not tied to any particular symptom constellation, so it can be applied to a variety of presenting concerns (Hayes, Luoma, et al., 2006; Öst, 2008, Powers et al., 2009), resulting in reduced training burden for clinicians and less need for applying sequential treatments to address co-morbidities. ACT has good face validity (i.e., "it makes sense") and conveys a compelling message to young Service Members and Veterans. ACT asks individuals to move forward in accordance with one's values regardless of limitations rather than struggling against those limitations. ACT appears to be acceptable to patients (mean attrition of 15.4% in 13 RCTs (Öst, 2008). ACT is being widely disseminated without adequate evidence of its effectiveness for this important population.

Eligibility Criteria:
Inclusion Criteria:

* Previous deployment to OEF or OIF
* Current distress and impairment \[at least one Diagnostic and Statistical Manual version IV (DSM-IV) anxiety or depressive disorder as determined by the Mini International Neuropsychiatric Interview (MINI) or post-concussive symptoms (PCS) as determined by a positive traumatic brain injury (TBI) screen with a score of 25 or greater on the Rivermead with distress or impairment related to PCS\].
* Capable of giving informed consent.

Exclusion Criteria:

* Cognitive impairment that would interfere with treatment. Potential participants will be excluded if they screen positive for more than mild cognitive impairment on the Montreal Cognitive Assessment (MoCA; excluded if score \< 26).
* Severe psychopathology (psychosis, bipolar illness, urgent suicidality or self-injurious behavior) or untreated substance dependence in the past month.
* Anticipated change in pharmacologic intervention. Patients may stay on their current medications during the study but will be asked to refrain from beginning or altering medication use during the study to the extent possible.
* Other psychotherapy focusing on the same target symptoms. Patients may attend self-help groups or treatment for other types of problems (e.g., couples counseling) but not other treatment for the same presenting problems.
* Anticipated deployment or other circumstance that would interfere with completion of all study procedures.
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder

The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided consent prior to any study specific procedures
* Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for MDD
* New patients must have ongoing inadequate response to protocol allowed ADTs as reported in Antidepressant Treatment Response Questionnaire (ATRQ)
* For rollover patients from RGH-MD-72 \[NCT01715805\], completion of Study RGH-MD-72 (either double-blind or single-blind treatment periods) with continued ADT treatment.

Exclusion Criteria:

* Patients who do not meet the DSM-IV-TR criteria for MDD.
Effect of Sevoflurane, Propofol and Dexmedetomidine on Delirium & Neuroinflammation in Mechanically Ventilated Patients

Assessment of sedative effects of sevoflurane, dexmedetomidine and propofol on the clinical course of delirium, SIRS and neuroinflammation in mechanically ventilated patients using CAM-ICU scale, GSK-3beta and protein S100b in serum.


Eligibility Criteria:
Inclusion Criteria:

* presence of delirium

Exclusion Criteria:

* presence of Alzheimer's disease
* any mental disorder
* presence of cancer
Value of Physical Capacity Tests in Lung Cancer

The study examines the physical capacity of lung cancer patients assessed with the six minute walk test and handgrip strength. Demographic and selfreported exercise behavior is registered to explore correlations to functional and physical capacity.

Assessments are made before first chemotherapy cycle and after fourth chemotherapy cycle, an expected average of 12 weeks between first and second assessment.


Eligibility Criteria:
Inclusion Criteria:

* Non small cell lung cancer stage I-IV
* Small cell lung cancer
* Patients \>18 years
* WHO performance status 0-2
* undergoing chemotherapy

Exclusion Criteria:

* unstable angina during the previous month
* myocardial infarction diagnosed within the last month
* not approval for physical activity by primary oncologist
* inability to provide informed consent.
Efficiency Of Different Intraoral Scanning Techniques In Orthodontic Patients Before And After Brackets Positioning: A Cross Sectional Study

A Cross-sectional study, in which we compare the efficiency of different scanning techniques in orthodontic patients before and after brackets positioning.

Scanning of the maxillary and mandibular dental arch will be performed for the same group of patients twice. The first time is before bracket positioning using two different scanners and the three different techniques. The second time is after brackets positioning using the same two different scanners and the same three different scanning techniques.

Then these scans will be compared to by superimposition techniques and linear measurement techniques.

In this study two scanners will be utilized Medit i500 and Trios 3. For each scanner three techniques will be used at two different interventions. One before brackets positioning and the other after bracket positioning. American orthodontics ROTH prescription, 0.022 slot metal brackets will be positioned using direct bonding technique.

Three different scanning techniques will be used: buccopalatal technique, S-shaped technique and palatobuccal technique. The buccopalatal technique (A) involves scanning the arch top side starting from the left second molar then run longitudinally to the contra-lateral one. Then go to the buccal side scan from this right side to the contra-lateral side and then palatal scan. Palatal scan done in two steps first was with counterclockwise movement along the palatal vault and then longitudinal movement in postro-anterior direction.

The S-shaped technique (B) involves scanning the arch starting from the palatal side of the left second molar then moving the scanner tip in alternating palatobuccal and buccopalatal S-shaped movement along the arch to the contra-lateral side. Then scanning the mid area of the palate by longitudinal movement in postro-anterior direction.

The palatobuccal technique (c) done by scanning the arch top side first starting from the left second molar runs longitudinally to the contralateral side. Then start palatal scanning by moving the scanner tip with circular movement in a clockwise direction across the palatal vault from the right-side second molar then along the palate to the contralateral second molar. Then the same circular scanning but in the counterclockwise direction to record the remaining part of the palate staring from the left second molar to the contralateral one. The buccal scan will follow starting from the right second molar then run longitudinally to the contralateral side.

Eligibility Criteria:
Inclusion Criteria:

Adolescent patients.

Fully erupted permanent dentition from second molar to the contra lateral second molar in both jaws.

Exclusion Criteria:

Severe degree of malocclusion that prevent full arch bracket positioning

Dento-facial deformity such as cleft lip/ palate or cranio-facial syndrome.

Severe Skeletal discrepancy in any of the three planes of space.

TMD problem

Limited mouth opening

Presence of crowns or bridges.
Cranial Electrotherapy Stimulation (CES) for Soldiers With Combat-Related Symptoms

The purpose of this double-blind randomized control research study is to determine if CES given in a group setting for soldiers experiencing irritability is effective to reduce the symptom of irritability.


Eligibility Criteria:
Inclusion Criteria:

* Soldiers over 18 years old or emancipated minors willing to sign an informed consent and complete all protocol requirements.
* Soldiers who score 4 or greater on the visual analog scale for irritability

Exclusion Criteria:

* Seizure disorders.
* Pregnancy. All female Soldiers will verify in the informed consent that they are not currently pregnant. Safety of stimulation has not been established during pregnancy and therefore we will exclude women who are or want to become pregnant during the course of the study.
* Concomitant therapy with an investigational drug or device, or participation in an investigational drug or device study within one month prior to entering this study
* Patients with a pacemaker or implanted defibrillator. The Alpha-Stim 100 may effect the operation of cardiac pacemakers (particularly demand type pacemakers) and therefore this population will be excluded from this study.
Vascular Thrombus Involvement in Nephroblastoma

Nephroblastoma (Wilms tumor) is the most common kidney tumor in children. It is a malignant embryonic tumor with a good prognosis with more than 85% long-term survival with appropriate chemotherapy, surgery (which most often consists of a total nephrectomy) and radiotherapy for locally invasive forms. Some nephroblastomas (approximately 10%) present with vascular extension with vena cava thrombus, a situation which may worsen the prognosis due to the complexity of the surgery. While the oncological treatment of nephroblastoma is highly formalized, to date there is no specific guideline on the surgical management of this rare clinical presentation of nephroblastomas.

The aim of the study is to provide recommendations for the surgical management of nephroblastomas with vena cava thrombus in a large multicenter series.

Nephroblastoma (Wilms tumor) is the most common kidney tumor in children. It is a malignant embryonic tumor with a good prognosis with more than 85% long-term survival with appropriate chemotherapy, surgery (which most often consists of a total nephrectomy) and radiotherapy for locally invasive forms. Some nephroblastomas (approximately 10%) present with vascular extension with vena cava thrombus, a situation which may worsen the prognosis due to the complexity of the surgery. While the oncological treatment of nephroblastoma is highly formalized, to date there is no specific guideline on the surgical management of this rare clinical presentation of nephroblastomas.

The management of children with nephroblastomas with vena cava thrombosis is very specific because of the vital risks to diagnosis, especially pulmonary embolism but also cardiac arrest (in the event of extension in the right atrium) and Cerebrovascular accidents by embolism, rarer. Surgery of the primary tumor and its intravascular extension is complex and may require the use of extracorporeal circulation, a source of significant morbidity and even mortality. These patients who will actually have a single kidney are at high risk for renal failure due to possible contralateral kidney damage during surgery. Surgery is not clearly codified because cases are rare, including in expert centers.

The aim of the study is to provide recommendations for the surgical management of nephroblastomas with vena cava thrombus in a large multicenter series.

Eligibility Criteria:
Inclusion Criteria:

* Minors with nephroblastoma with vena cava thrombosis +/- atrial extension.
* Cared between 1999 and 2019 in the centers of the study.

Exclusion Criteria:

- Other renal and non-renal tumors with vena cava thrombosis.
RIGHT: Rhythm ID Going Head-to-Head Trial

RIGHT is a randomized, prospective, two-arm study that will assess the differential efficacy of VITALITY 2 implantable cardioverter defibrillators (ICDs) using Rhythm ID™ versus selected Medtronic ICDs.

RIGHT will compare the incidence of Ventricular Tachycardia/Fibrillation (VT/VF) therapies delivered for Supraventricular Tachycardia (SVT) episodes using VITALITY 2 devices with Rhythm ID™ to that of ICDs employing other rhythm discrimination algorithms. Appropriateness of therapies will be assessed after independent adjudication of all VT/VF events leading to therapy. Comparisons will be made between device manufacturers across patient populations receiving either a dual- or single-chamber device.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet current indications for an ICD
* Patients who sign and date a Patient Informed Consent form prior to the implant visit
* Patients who remain in the clinical care of the enrolling physician in approved centers
* Patients who are able to tolerate ICD programming as specifically prescribed in the study protocol

Exclusion Criteria:

* Patients who are in third degree heart block
* Patients whose life expectancy is less than 12 months
* Patients who have other cardiac surgeries or procedures planned but not yet performed during the duration of the study
* Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study
* Patients who are younger than 18 years of age
* Patients who are mentally incompetent and cannot sign a Patient Informed Consent form or comply with the study
* Patients who are pregnant or plan to become pregnant during the study
Acute Effects of Vigorous-intensity Aerobic Exercise on Glymphatic Flow in Healthy Adults

This study investigates changes in glymphatic flow in the brain acutely after vigorous-intensity steady-state aerobic exercise. Twenty subjects (10 male and 10 female) perform 25 minute submaximal cycle ergometry exercise and the changes in the glymphatic flow and cerebral perfusion are evaluated using a variety of MRI sequences (e.g. MREG).

The glymphatic system is a drainage system for the brain to help maintain fluid balance and extract waste metabolites. Glymphatic system function (healthy glymphatic flow) may prevent accumulation of harmful substances and therefore slow down the onset of neurodegenerative diseases.

The hypothesis is, that glymphatic flow could be increased through exercise and enhanced cerebral arterial pulsality, which might explain some of the brain health benefits of exercise proven in epidemiological studies. This study indirectly investigates the acute changes in the glymphatic flow acutely after aerobic exercise using MREG that measures pulse wave propagation as an indirect surrogate marker for glymphatic flow.

Twenty healthy subjects (n=20, 10 male, 10 female, age 18-45 years) will perform 25 minute 70%VO2max cycle ergometry exercise. The glymphatic flow and cerebral perfusion will be measured using magnetic resonance imaging sequences before and after exercise. The glymphatic flow is measured using 10 Hz fMRI technique called magnetic resonance encephalography (MREG). In addition, perfusion MRI is used to evaluate changes in brain perfusion.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45
* BMI 18-30
* Resting Blood pressure \< 140/90 mmHg

Exclusion Criteria:

* History of a cardiac event
* Insulin or medically treated diabetes
* Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results
* Presence of ferromagnetic objects that would make MR imaging contraindicated
* Claustrophobia
* Abundant use of alcohol
* Use of narcotics
* Smoking of tobacco or consuming snuff tobacco
* Diagnosed depressive or bipolar disorder
* Abnormalities in resting ECG (revised by the study physician)
* Pregnancy
Validity of the PortionSize App to Measure Children's Food Intake

The purpose of this study is to assess the validity of the PortionSize™ app to quantify children's own dietary intake and children's intake by parents or caregivers.

The investigators will recruit 40 dyads (40 children aged 7-12 years old and 40 parents or caregivers) using a convenience sample for this pilot study. Children and their parents or caregivers will be trained to use the PortionSize app at Pennington Biomedical Research Center (PBRC). Children will use the PortionSize app and estimate food intake from pre-weighed meals (simulated meals) at PBRC clinic. Children will not consume the simulated meals. Children's parents or caregivers will also use the PortionSize app and estimate the food intake of their children (at least one meal and a snack each day) for two consecutive days at home.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Children (7-12 years) and their parents or caregivers (18-62 years)
* Parents who have Willingness to use the PortionSize app to estimate the intake of their child food intake (normal/regular diet) from at least a snack and a meal of child for two consecutive days
* Have iPhone (version 6 or above) and an operable Apple ID, password, and email address, and able to use iPhone

Exclusion Criteria:

* Any condition or circumstance that could impede study completion
* Child who is a very choosy eater or has a very limited food choice
Improvement of the Selenium Supply in a Vegan Diet by Different Selenium Sources

As vegans are among the individuals with the lowest serum selenium levels, the randomized controlled SelVeg study aims to address the question of whether Brazil nuts could be an adequate source of selenium for diets potentially low in selenium. For this purpose, we will investigate in individuals with a vegan or omnivorous dietary pattern how a daily selenium intervention in the form of a food (here Brazil nut butter) or an over-the-counter selenium supplement affects the selenium status.

The vegan diet is characterized by an exclusion of all animal foods and is associated with positive health effects. However, dietary restriction can lead to inadequate intake of both macro- and micronutrients. Selenium and zinc, among others are critical nutrients in a vegan diet. Brazil nuts represent a particularly selenium-rich plant food. In addition to selenium Brazil nuts have also relevant amounts of other trace elements, including zinc, iron and copper.

Therefore, the aim of this study is to evaluate the effect of a daily selenium supplementation in the form of Brazil nut butter in comparison to a selenium supplement. As primary outcome, the serum selenium concentration and other serum biomarkers of the selenium status will be analyzed. Additionally, serum levels of other trace elements such as zinc will be quantified. Dietary questionnaires will provide information on dietary intake of nutrients (focus on dietary fiber, zinc and phytate intake) to identify potential factors influencing selenium bioavailability.

The SelVeg study will enroll 90 healthy subjects with either a vegan (defined as exclusion of animal products) or omnivore (defined as weekly consumption of meat and/or sausage) dietary pattern. After categorizing in vegans or omnivores, participants are than randomized in one of the three intervention groups (placebo, Brazil nut or selenium supplement) and will receive 55 µg of additional daily selenium (as Brazil nut butter or tablet) or no additional selenium in case of placebo. The intervention period is 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy participant
* Adherence to one of following eating habit (vegan or omnivore) confirmed by food frequency protocol (5 d), lifestyle and nutrition questionnaires
* Stable eating habit for at least 1 year before enrollment

Exclusion Criteria:

* Diet other than omnivore or vegan
* Changing diet during the study period
* Baseline serum selenium concentration \> 150 µg/L
* Acute or chronic disease (tumor, infection, other), gastrointestinal diseases, chronic renal disease, diseases of the parathyroids, diseases necessitating regular phlebotomies
* Nut allergy
* Pregnancy or lactation
HyperAldosteronism in Pregnancy Predicted Impacts (H.A.P.P.I. Trial)

Primary hyperaldosteronism confers a higher risk of cardiovascular complications compared to essential hypertension. Preliminary data is controversial in regards of excessive maternal fetal and neonatal excessive risks in pregnancy.

This study aims at establishing the prevalence of PHA in an population with a recent episode of hypertensive disorder of pregnancy (HDP). The goal is to determine if a universal screening for PHA after a HDP is worthed. The investigators also wish to evaluate the complication rate in pregnant women with PHA compared to women without PHA.

This is a prospective cohort study where all eligible women will be screened for PHA after a HDP episode in the last pregnancy. We will then compare PHA women to non PHA women according to pregnancy complications.

This is a pilot study to evaluate feasibility and proof of concept. This is a prospective multicenter cohort study. Two university centers will participate (Sherbrooke and Montreal).

Participants will be recruited from post-partum Obstetric Medicine clinic in two tertiary care centers. They will be included if they presented a hypertensive disorder of preganncy (HDP) in their last pregnacy (from 4 weeks to 24 months after delivery). Women with pheochromocytoma, Cushing syndrome, secondary hyperaldosteronism, and those who are currently pregnant will be excluded.

All participants will be screened for PHA (with an aldosterone/renin ratio) and if the screening test is positive, they will be referred to a specialist to confirm the diagnosis.

Data will be collected from the participants and their babies' charts. Demographic data, obstetrical data, delivery data, maternal/fetal/neonatal complications, and diagnostic of PHA data will be collected.

A convenient sample size of 200 women will be used. If the prevalence of HPA is 5% or more, this would justify a larger study.

Primary outcome: establish the prevalence of PHA in women with a hypertensive disorders of pregnancy in last pregancy.

Secondary outcome include:

1. to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (PHA) and pregnant women without PHA.
2. to establish the prevalence of PHA for each sub-type of hypertensive disorder of pregnancy
3. to compare maternal, fetal and neonatal outcomes among women diagnosed with primary hyperaldosteronism (PHA) before pregnancy and pregnant women diagnosed with PHA after pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Between 4 and 24 weeks post-partum women who had a hypertensive disorder during their latest pregnancy.

Exclusion Criteria:

* Ongoing pregnancy
* Diagnosed pheochromocytoma
* Diagnosed Cushing syndrome
* Diagnosed secondary hyperaldosteronism