cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Vortioxetine (Lu AA21004) in the Treatment of Patients With Major Depressive Disorder

The purpose of this study is to determine the efficacy and safety of vortioxetine, once daily (QD), in adults with major depressive disorder.

The drug that was tested in this study is called Vortioxetine. Vortioxetine is being tested to treat depression in adults who have major depressive disorder (MDD). This study looked at MDD relief in people who took varying dosages of vortioxetine.

The study enrolled 611 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the four treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Vortioxetine 2.5 mg
* Vortioxetine 5 mg
* Duloxetine 10 mg
* Placebo (dummy inactive capsule) - this was a capsule that looked like the study drug but had no active ingredient.

All participants were asked to take one capsule at the same time each day throughout the study.

This multi-center trial was conducted in the United States. The overall time to participate in this study was up to 12 weeks. Participants made 8 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria.
* The reported duration of the current major depressive episode is at least 3 months.

Exclusion Criteria:

* Has 1 or more the following:

  * Any current psychiatric disorder other than major depressive disorder as defined in the DSM-IV-TR.
  * Current or past history of: manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
  * Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
  * Presence or history of a clinically significant neurological disorder (including epilepsy).
  * Neurodegenerative disorder (Alzheimer disease, Parkinson disease, multiple sclerosis, Huntington disease, etc).
  * Any Axis II disorder that might compromise the study.
* Has a significant risk of suicide according to the investigator's opinion or has a score ≥5 on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale (MADRS) or has made a suicide attempt in the previous 6 months.
* The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each.
* Has received electroconvulsive therapy within 6 months prior to Screening.
* Is currently receiving formal cognitive or behavioral therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
Virtual Reality in End Stage Kidney Disease

The goal of this clinical trial to compare the social virtual reality and individual virtual reality in patients with end stage kidney disease who are hemodialysis. The main aim is to determine if there are differences in symptoms between the groups. Participants will use virtual reality glasses for 30-45 minutes during dialysis sessions for 4 weeks.

In a single site, 2-arm (Social Virtual Reality group; Individual Virtual Reality Group), parallel, randomized controlled trial we will enroll 60 subjects (n=30 per group) to assess the effects of Social Virtual Reality to Individual Virtual Reality on symptoms in participants with end stage kidney disease who are receiving hemodialysis.

To compare the effects of social virtual reality to individual virtual reality on loneliness To explore the effects of social virtual reality to individual virtual reality on anxiety and depression.

To compare the effects social virtual reality to individual virtual reality on quality of life.

Eligibility Criteria:
Inclusion Criteria

* Diagnosis of end stage kidney disease with hemodialysis 3 times per week for at least 1 month

Exclusion Criteria

* Acutely ill
* Active nausea
* Epilepsy
Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:

A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.

A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.

Eligibility Criteria:
Inclusion Criteria:

* Meets labeling indication for use per information for prescribers
* Target is accessible by Focused Ultrasound per treatment planning parameters

Exclusion Criteria:

* Do not agree to participate or who are unlikely to participate over an extended period of time
Effect of Commute Traffic on Vascular Function

The investigators will assess the vascular effects of riding in a car in heavily trafficked roadways, and whether filtering the car's air reduces those effects.

In this double-blind, crossover trial, randomized to order, recruited participants will be screened and then will accompany the study team on three typical commutes on separate days with sufficient washout (i.e., three weeks) between drives. One day this will occur with an effective filter system in the vehicle and the other two days without effective filtration; ineffective filtration is the most typical actual vehicle condition. Subjects will be unaware of the filtration conditions of the commute on that day. Each subject's experimental sessions will occur at the same time of day and will be separated by at least 21 days. The two sessions (either filtered air or traffic-derived entrained air) will be 120 minutes in duration and will encompass routes on heavily traveled roadways in the Seattle area. Before subjects begin the commute trials, they will go through the consent process and a series of screening tests. The study investigators will assess a series of measures regarding vascular function before and after each drive.

Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* asthma,
* high blood pressure,
* diabetes,
* high cholesterol,
* other chronic conditions requiring ongoing medical care.
Noninvasive Brain Stimulation on Memory in Individuals With Mild Cognitive Impairment and History of Brain Injury

The study will examine the efficacy of high definition transcranial direct current stimulation (HD-tDCS) and its influence on episodic memory in patients with amnestic mild cognitive impairment and a history of Traumatic brain injury. Ten sessions of HD-tDCS to the dorsal anterior cingulate region is expected to result in improvements in episodic memory measures immediately following the last session and at a 3-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 and older
* Native English speakers
* 12 years of education or higher
* Active diagnosis of aMCI
* History of TBI based on VA/DOD criteria

Exclusion Criteria:

* TBI within the past 2 years
* Lifetime history of stroke, transient ischemic attack, heart attack, or congestive heart failure
* Lifetime history of epilepsy
* Major psychiatric disorders (i.e., posttraumatic stress disorder, bipolar disorder, schizophrenia)
* Substance use disorder
* Has metal fragments in head
* Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)
IV Iron in Association With Tranexamic Acid for Hip Fracture

It is a prospective randomized controlled study aiming to test if tranexamic acid combined to intravenous iron before and after surgery for hip fracture in elderly can decrease peri-operative red cell transfusion.

Hip fracture is an increasing problem. Anemia is a common finding in these patients with a prevalence ranging from 24% to 44% and is a strong negative prognostic marker. Several studies have explored whether interventions to improve anemia result in better outcomes. Thus, alternatives to allogenic red cell transfusion have been suggested in hip fracture, such as IV iron and tranexamic acid.

The aim of the study is to test the effect of combination of IV iron with tranexamic acid before and after surgery for hip fracture on incidence of peri-operative red cell transfusion.

It is a prospective randomized single-blinded monocentric study including 150 patients undergoing hip fracture surgery within 72 h after trauma aged ≥ 60 years divided in 3 groups: Group A (IV fer+Tranexamic acid), Group B (Tranexamic acid), Group C (placebo). The main outcome was percentage of patients who receive red-cell transfusion during hospitalization. Hemoglobin levels up to 60 days post-operatively and incidence of thrombotic events were secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing hip fracture surgery within 72 h after trauma.

Exclusion Criteria:

* Vascular events within the last 2 months such as cerebrovascular accident (CVA), Myocardial infarction (MI), Venous Thromboembolism (VTE) and/or recurrent VTE or arterial thrombosis.
* Patients receiving anticoagulation therapy with warfarin or clopidogrel.
* History of seizures.
* Multiple fractures.
* Transfusion received during admission, prior to surgery (Hb\< 8g/dl).
* Creatinine clearance less than 30 mL/min
* Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
* Coronary stent placement within the previous 6 months
* Disseminated intravascular coagulation
* Subarachnoid hemorrhage
* Allergy for tranexamic acid
* Hypersensitivity to Iron sucrose or any component of the formulation
* Clinical signs of acute thromboembolic event
* Malignancy
* Body weight \> 100kg
* Advanced Dementia
Testing Conversation Aid in Practice

The goal of this research study is to develop and test a website to help primary care providers (PCPs) discuss the pros and cons of mammography with women aged 75 and older and to help participants make decisions about mammography.

This research study is to conduct a pilot pretest-posttest trial to learn if providing a web-based conversation aid (CA) on mammography screening to 36 primary care providers facilitates shared decision making (SDM) and 8 medical assistants with 190 of their patients (2-3 per PCP) aged 75-89 years and 23 involved family members.

Research procedures include screening for eligibility, questionnaires, and clinic visits.

Participation in this research study is expected to last about 4 months.

It is expected about 90 participants, 23 participant family members, 36 primary care providers, and 8 medical assistants will participant in this research study.

The National Institute on Aging is supporting this research study by providing funding.

Eligibility Criteria:
Participant Inclusion Criteria:

* English-speaking
* Aged 75 - 89 years
* Seen by an attending-level (non-resident) seen at the recruitment practices who have the -Ability and willingness to provide verbal consent.

Participant Family Members Inclusion Criteria:

* Family member of patient that has agreed to participate in the study
* Age \>18
* English speaking
* Ability and willingness to provide verbal consent

Primary Care Provider Inclusion Criteria:

* Non-resident physician, nurse practitioner, or physician assistant

  -\>18 years old
* English speaking
* Cares for a panel of patients that includes women \>75 years at one of the recruitment practices
* Ability and willingness to provide verbal consent

Participant Exclusion Criteria:

* Last mammogram \<6 or \>30 months (so that participants may be contemplative of their next mammogram)
* History of dementia
* Incapacity for informed consent
* History of invasive or non-invasive breast cancer
* Last mammogram was abnormal
* Non-English speaking
* Already chose to stop being screened (documented in medical records or scores of 1-3 \[do not intend to be screened\] on a validate 15 point intentions to be screened scale.)
* PCP unwilling to have patient participate
* In hospice
* PCP not willing to participate
* Psychiatric illness situations that would limit compliance with study requirements

Participant Family Member Exclusion Criteria:

* Age \<18
* Non-English speaking
* Psychiatric illness situations that would limit compliance with study requirements

Primary Care Provider Exclusion Criteria:

* Resident physician
* Psychiatric illness situations that would limit compliance with study requirements
Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy

The purpose of this study is to improve early detection of treatable relapse of lung cancer and thereby improve survival and quality of life for the patients. The investigators will perform a multicenter, randomized controlled trial to 1) assess if surveillance with whole body Positron Emission Tomography combined with Computer Tomography (PET/CT) including the brain can increase the number of treatable relapses and 2) concurrently collect liquid biopsies for later analysis, potentially enabling even earlier and minimally invasive detection and characterization of relapse.


Eligibility Criteria:
Inclusion Criteria:

* Patient with non-small cell lung cancer (NSCLC), proven by cytology or histology
* Patient in clinical stages I-III
* Age≥ 18 years
* Performance status ≤ 2 at the time of referral to therapy
* Patient referred for definitive treatment (e.g. surgery, surgery followed by adjuvant chemotherapy, concomitant radio-chemotherapy, conventional or stereotactic radiotherapy or radiofrequency ablation).
* Patient has given his/her written informed consent before any specific procedure from protocol

Exclusion Criteria:

* Patient, whose disease has progressed within the first 3 months after cancer treatment, e.g. confirmed progressive disease on CT.
* Persons deprived of liberty or under guardianship or curators
* Dementia, mental alteration, severe psychiatric disease or other circumstances that can compromise informed consent from the patient and/or adherence to the protocol and the monitoring of the trial
* Pregnant or breastfeeding women
* Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention, whereas studies on late effects will not preclude participation in SUPE-R. Participation in protocols related only to initial treatment will not preclude participation in SUPE-R. Cases of doubt will be settled by the steering committee.
Pandemic Triage Score in Patients With Known or Suspected Severe Acute Respiratory Syndrome (SARS) CoronaVirus (CoV) 2 Infection

During this pandemic period, the goal of the health care system is to optimize the use of intensive care services for patients infected with SARS-CoV-2, given the frequency of complications that can lead to high mortality.

When patients with suspected or confirmed COVID-19 are admitted to hospital, whether or not they are symptomatic, there is currently no method to predict who will progress to complications requiring the use of intensive measures in 24-48 hours.

The body undergoes a systemic adaptation response to severe illness. Elevated cortisol and systemic inflammation are two key responses. Along with hypotension, this triad can lead to end-organ failure and death in critical illness. In critical illness, serum cortisol is dissociated from its tissular activity. We have developed a formula that calculates tissular action of cortisol called the cortisol index. It correlates in chronic ambulatory illness, and acute illness such as myocardial infarction (manuscript pending). Elevated neutrophil to lymphocyte ration (NLR) is a marker of systemic inflammation and predictor of mortality on admission to the emergency department. We have confirmed this in a retrospective and prospective study (manuscript pending, data available upon request).

The purpose of this study is to evaluate a triage score (STC-19) based on patients' biological state at the time of diagnosis, to objectively determine which patients are most likely to require intensive medical services within 24-48 hours of presentation of the emergency department.

Eligibility Criteria:
Inclusion Criteria:

* Patient with clinical signs of CoV-2-SARS infection
* Complete blood count test and systolic blood pressure available at the time of diagnosis
* Informed of the study.

Exclusion Criteria:

* Women beyond the 1st trimester of pregnancy
* Persons under-the-age-of or legally-denied medical decision-making capacity by a judicial or administrative decision,
* Persons of full age who are subject to a legal protection measure,
* Persons unable to consent,
* Persons who are not members of or beneficiaries of a social welfare program administered by the Republic of France
* Patient's refusal to participate in the study.
TDCS and Aphasia Therapy in the Acute Phase After Stroke

This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the acute stage after stroke. Half of the participants will receive aphasia therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.

Aphasia is present in about one third of all stroke patients in the acute phase. The first few months after stroke, considerable spontaneous recovery is initiated, including neuronal plasticity and reorganization processes. Language recovery in aphasic stroke patients involves reorganization of brain functions. Longitudinal fMRI studies reveal that the right hemisphere shows increased activity at different times in the recovery process, but in the long-term is correlated with poorer performance. Left re-lateralization, if possible, seems to be the most effective in restoring language function. For a large subgroup of patients, aphasia therapy is not sufficient to resolve language deficits and not all patients are capable to endure intensive aphasia therapy. Therefore, non-invasive techniques (NIBS) such as transcranial direct current stimulation (tDCS) are currently explored as an add-on treatment to improve or accelerate therapy outcomes. tDCS is a painless and safe stimulation tool that modulates cortical excitability through weak polarizing currents (1 mA - 2 mA) between two electrodes. These weak currents are thought to induce a subthreshold shift of resting membrane potentials towards depolarization or hyperpolarization. The effects of stimulation depend on the polarity of the applied current relative to the axonal orientation. It has been found that tDCS not only triggers immediate aftereffects, but also long-lasting effects that persist beyond the stimulation time, even for up to 12 months. It was suggested that long-term potentiation (LTP) and long-term depression (LTD) might be responsible for these long-term effects, however the precise physiologic mechanisms of action are not yet fully understood.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with mild-moderate aphasia (Token Test Score between 7 and 40)
* Inclusion in the first few days after stroke (acute phase)
* Age 18 - 85 years
* Being right-handed
* Mothertongue: Dutch
* Able to undergo functional and specific linguistic testing and therapy in the acute phase following stroke
* Imaging (CT or MRI) prior to inclusion (standard of care)
* Signed Informed Consent

Exclusion Criteria:

* History of other diseases of the central nervous system, psychological disorders and (developmental) speech and or language disorders
* Serious non-linguistic, cognitive disorders (as documented in the patients' medical history and inquired in anamneses)
* Prior brain surgery
* Excessive use of alcohol or drugs
Assessing Effect of Withdrawal Time on Adenoma Detection Rate for Screening Colonoscopy

The investigators' null hypothesis is that a withdrawal time of 9 to 10 minutes is non-inferior to a withdrawal time of 12 minutes or greater. Thus, the goal of this tandem design trial is to compare the additional diagnostic yield (# of missed lesions) for withdrawal times exceeding 10 minutes for screening/surveillance colonoscopies. Although withdrawal times longer than the standard 6-minute recommendation have been shown to be beneficial, there is limited prospective evidence investigating the benefit or lack thereof for withdrawal times greater than 9-10 minutes.


Eligibility Criteria:
Inclusion Criteria:

* Must be between the ages of 18 and 75 years
* Must be a patient undergoing screening or surveillance colonoscopy
* Must be able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Inability to provide informed consent.
* Personal history of colorectal cancer (CRC)
* Personal history of colon surgery or colon resection
* Personal history of Inflammatory bowel disease
* Personal history of familial polyposis
* Current pregnancy
* Active GI bleeding
* Colonoscopy exams where the cecum cannot be reached (randomization will occur after cecum is reached).
Straberi Epistamp Needling Treatment For Skin Rejuvenation

This pilot study will expand knowledge and application needling using the Epistamp device for the improvement of a new vitalized epidermal layer with new vibrant active cells, supported by more robust collagen and elastin fine lines, deep wrinkles, and collagen production.

This pilot study will expand the knowledge and application needling using the Epistamp device and its benefits for improving the appearance of fine lines, deep wrinkles, and collagen production. The pilot aims to objectively measure skin quality using the Derma Scan, photographs and provide objective data showing improvement by way of the Universal Skincare Institute Blood Flow Scale.

Eligibility Criteria:
Inclusion Criteria:

* Derma Scan showing aging including skin texture, wrinkles, brown spots, and pores.
* Patients willing to sign informed consent.
* Patients willing to be photographed and video documented
* Patients willing to consent to 3 months of treatment

Exclusion Criteria:

* History of eczema in the treatment area; psoriasis and any other chronic skin conditions
* History of actinic (solar) keratosis in the treatment area;
* History of hemophilia
* History of diabetes
* The presence of raised moles, warts on the targeted area.
* Collagen vascular diseases or cardiac abnormalities
* Blood clotting problems
* Active bacterial or fungal infection
* Facial melanosis
* Malignant tumors
* Immunosuppression
* Use of blood thinners or prednisone
* Corticosteroids within two weeks of the procedure
* Chronic liver disease
* Porphyria or other skin diseases.
* Patient not willing to sign informed consent.
* TCA peels in the last 5 weeks
* Subject currently has moderate to severe acne on the face.
* Microneedling within the last 6 months
* Subject has an active infection.
* Subject has a history of a bleeding disorder
* Subject has a history of keloidal tendency
* Subject has received ablative or non-ablative laser treatments in the previous 6 months.
* Subject has taken Accutane within the previous 3 months.