cyrilzakka/clinical-trials huggingface dataset:
Accelerated Resolution Therapy for Complicated Grief

This study will examine whether accelerated resolution therapy (ART) is effective for the treatment of prolonged and complicated grief and associated psychological trauma among older adult hospice caregivers who have experienced the death of an immediate family member at least 12 months ago.

ART is an evidence-based therapy for the treatment of depressive symptoms and trauma and stress-related disorders that includes the core components of trauma-focused therapy including imaging rescripting, voluntary image replacement, guided visualization with use of eye movements, desensitization and processing of distressing memories, and in-vitro exposure to future feared triggers. Mental health professionals are delivering ART in clinical practice to assist with grief; however, there is a need for formal research evaluation of the effects of ART on complicated grief and psychological distress.

Eligibility Criteria:
Inclusion Criteria:

* Adult age 60 years of age or older
* previous primary caregiver of immediate family member who died after enrollment in hospice with the death occurring at least 12 months prior to enrollment
* current symptoms indicative of proposed diagnostic criteria for complicated grief disorder, as proposed by Shear et al. (2011)
* current score of \>25 on the 19-item Inventory of Complicated Grief
* current symptoms indicative of significant psychological trauma, as documented by score \>33on the 20-item DSM-5 PTSD checklist (PCL-5)26 or score \>4 on the PDSQ PTSD subscale
* denial of suicidal ideation or intent, with no evidence of psychotic behavior

Exclusion Criteria:

* engaged in another psychotherapy regimen that could also influence symptoms of PCG - - major psychiatric disorder (e.g. bipolar disorder) deemed likely to interfere with treatment delivery
* current substance abuse dependence (alcohol and/or drug) treatment anticipated to interfere with treatment delivery.
Intravitreal Bevasizumab Versus Intravitreal Triamcinolone in Central Retinal Vein Occlusion (CRVO)

This randomized clinical trial is conducted to evaluate the effect of three intravitreal injections of bevasizumab versus two intravitreal injections of triamcinolone in acute central retinal vein occlusion. The outcomes are visual acuity and central macular thickness. The follow-up time is 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Recent onset (less than 3 months) central retinal vein occlusion

Exclusion Criteria:

* Any previous intervention
Reducing Reintubation Risk in High-Risk Cardiac Surgery Patients With High-Flow Nasal Cannula

The purpose of this study is to compare reintubation rates and outcomes of patients treated with high-flow nasal canula oxygen therapy (HFNC) and patients treated with provider choice of standard care.

HFNC may be employed as a strategy to facilitate early extubation and prevent reintubation of patients following cardiac surgery. HFNC is routinely employed by providers in the cardiovascular intensive care unit and is selectively employed in patients who are judged by the provider to be high-risk, along with other therapies: bi-level positive airway pressure, non-rebreather masks, among others. Currently, no high-quality clinical data exist to demonstrate that HFNC may decrease the risk of reintubation in this critically-ill adult population.

To guide a future, larger, multicenter randomized controlled pragmatic clinical trial, a pilot study in a single, high-volume cardiovascular intensive care unit will be performed. The prospective, randomized, pragmatic pilot clinical trial will compare HFNC to provider choice of standard care in these high-risk patients.

Randomization will occur at the time that the patient is deemed ready for extubation by the attending physician in the cardiovascular intensive care unit. Through randomization, patients will be assigned one of two physician order sets in the electronic medical record system: standard order set with or without recommendation for the use of HFNC. Reintubation and outcome data will be collected until patient discharge.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and over treated in the Vanderbilt Cardiovascular Intensive Care Unit following cardiac surgery (defined as surgery on the heart or thoracic aorta, excluding percutaneous procedures)
* Surgical duration (anesthesia start to anesthesia stop) of at least 3 hours.
* Intubated at the time of arrival in the Cardiovascular Intensive Care Unit
* Extubated to occur at some point following arrival in the Cardiovascular Intensive Care Unit with an order to extubate the patient by a treating provider.

Exclusion Criteria:

* Does not meet inclusion criteria
Safety & Effectiveness of the BEAM Device in Mild-to-moderate Acne

This study will determine if the use of the BEAM device reduces the signs and symptoms of mild-to-moderate acne.


Eligibility Criteria:
Inclusion Criteria:

1. Age 15 years or older of either gender and of any racial/ethnic group.
2. At least 8 acne inflammatory lesions (see section 9) in the treatment and control areas.
3. Presence of clinically-evident facial acne of mild-to-moderate severity (score 2-4 on the Global Acne Severity Scale, see below)
4. Subjects must be in generally good health.
5. Subjects must be able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

1. Oral retinoid use within six months of entry into the study.
2. Systemic acne therapies (oral antibiotics) within 2 weeks of entry into the study.
3. Topical acne therapies (retinoids, antibiotics) within 1 week of entry into the study.
4. Microdermabrasion or superficial chemical peels at the site to be treated within 2 months of entry into the study.
5. Subjects with a history of dermabrasion or laser resurfacing at the site to be treated.
6. Use of topical lipid absorbing substances (Clinac AC) within 1 week of entry into the study.
7. Non-compliant subjects.
8. Subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation.
9. Subjects using alcohol-based topical solutions or "exfoliating" agents within 1 week of entry into the study.
10. Subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections.
11. Pregnant or nursing females.
12. Subjects with known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
13. Subjects who have a history of significant post-inflammatory hyperpigmentation at the sites of acne lesions.
Transcutaneous Electrical Stimulation & Sinoatrial Node Function

Transcutaneous electrical stimulation (TES) is used in clinical practice to diagnose or treat a diverse range of medical conditions for over a century. Although the benefits of TES are well known, its potential side effects on the heart have not been convincingly clarified. This study will test whether TES has any effect on the sinoatrial node (SAN).

It was hypothesized that: 1) TES has effects indirectly via peripheral afferents or directly on the SAN, and 2) TES causes a change in the R-R interval (HRV). The aim of this study was to test these hypotheses.

This research protocol will have three phases: first, the effect of a single electrical pulse on heart rate variability (HRV) will be examined in Experiment I. The effects of conventional TENS and acupuncture-like TENS on HRV will be also investigated in Experiment II. Finally, the effect of time and rest on the HRV will be tested in Experiment III. Subjects will be in a sitting position with 90-degree flexion at the elbow and supination of the hand during electrical stimulation. A pair of square (4 x 4 cm), self-adhesive, pre-gelled skin electrodes will be used for stimulation. The electrodes will be placed over the flexor aspect of the right forearm. Three-lead electrocardiogram (ECG) recording will be obtained to determine the change of HRV during rest and electrical stimulation sessions. The participant's ECG data will be continuously captured by noninvasive sensors \[self-adhesive pre-gelled Ag/AgCl surface electromyography (sEMG) electrodes, Redline® Istanbul, Türkiye\] transmitted through a data acquisition system.

The main outcome variable is the heart rhythm. In this context, electrical stimulus-related QRS wave and RR interval change (heart rate variability) will be examined. The possible direct effect of an electrical stimulus on the appearance of the QRS wave will be investigated in the time domain using the Peristimulus time histogram and the Waveform average technique. ECG data will be analyzed using a software package (Cambridge Electronic Designs, Cambridge, UK).

Eligibility Criteria:
Inclusion Criteria:

* Healthy young adult volunteer

Exclusion Criteria:

* Pregnancy
* Alcohol or drug abuse,
* Any medication with potential effects on the cardiovascular system
Development, Piloting and Evaluation of an Evidence-based Informed Consent Form for Total Knee Arthroplasty

Every medical intervention requires informed consent. Informed consent may include comprehensible information about the necessity and kind of the intervention, material risks and consequences or alternative treatments. Practitioners frequently use consent forms to support the physician-patient conversation and to document informed consent. Studies show, that informed consent forms used in practice, are heterogeneous.

This study aims at investigating the effects of evidence-based informed consent forms for Total Knee Replacement and related anaesthesia procedures.

Evidence-based informed consent forms include best and latest evidence in lay language. It is hypothesized that evidence-based informed consent forms - compared to standard consent forms - improve patients' risk perception, reduce anxiety of complications and reduce the nocebo effect (unspecific negative effects caused by the way of communicating risks).

To compare evidence-based and standard informed consent forms, an Interrupted Time Series pilot study will be conducted. It is planned to include 220 patients, who are scheduled for elective total knee replacement surgery.

The accompanying qualitative analyses ensure that the (German) legal requirements for informed consent are met.


Eligibility Criteria:
Inclusion Criteria:

* Patients are scheduled for an elective total knee arthroplasty surgery
* Patients are at least 18 years old
* Patients are able to understand and speak German
* Patients are mentally competent to give consent and answer questions

Exclusion Criteria:

* Patients with revision
* Patients with posttraumatic arthrosis
Open-Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Tamoxifen When Coadministered To Healthy Post-Menopausal Female Subjects

The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy post-menopausal female subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy post-menopausal female subjects, at least 45 years of age, with confirmed post-menopausal status
* Hysterectomized subjects
* Body Mass Index (BMI) less than or equal to 34.0 kg/m2
* Nonsmoker or smoker of fewer than 5 cigarettes per day as determined by history
* An informed consent document signed and dated by the subject

Exclusion Criteria:

* History of significant blood, kidney, endocrine, lung, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic disease
* Presence or history of deep vein thrombosis or transient ischemic attack
* History of seizure disorder
* Presence or history of glaucoma or increased intraocular pressure
* Allergy to or unable to tolerate tamoxifen, desvenlafaxine, or venlafaxine
* History of substance abuse within 1 year of study
* A positive urine drug screen
* Treatment with an investigational drug within 30 days
* Consumption of grapefruit or grapefruit related citrus fruits
* 12 lead ECG demonstrating QTc \>450 msec at screening
* Pregnant or nursing females
* Use of prescription or nonprescription drugs and dietary supplements
* History of sensitivity to heparin or heparin induced thrombocytopenia
* Severe acute or chronic medical or psychiatric condition or laboratory abnormality
* Use of CYP 2D6 inhibitors and CYP 3A4 inhibitors/inducers
Effect of a New Infant Formula With Specific Ingredients

The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life.

Nowadays, almost all commercial infant formulas resemble the "gold standard" of breast milk in terms of composition of essential nutrients, but it is still a challenge to identify and incorporate certain bioactive components capable of replicating those stimuli typical of breast milk that can program growth, infant development and maturation of the immune system.

The purpose of this study is to test whether the addition of certain bioactive ingredients to a new infant formula (HMOs, osteopontin and probiotics) can have a favorable impact on the development of the infant's immune system in the first months of life.

In addition, considering that the quality of feeding at these early ages will program (Early programming) the health and physiology of the child and the future adult, the study wants to obtain evidence of the effects of this new infant formula on the immune system and the development of the child compared to breast milk during the first year of life, hoping that it promotes proper growth, adequate cognitive development and maturation of the immune system as similar as possible to children fed to the mother's breast.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion age from 0 to 2.5 months of age.
* Gestational age \>37 weeks and \<41 weeks inclusive.
* Appropriate birth weight appropriate for your gestational age (between 10-90 percentiles).
* APGAR score normal birth to 1' and 5' of 7 - 10.
* Umbilical pH ≥ 7.10.
* Availability to continue throughout the study period.
* Written informed consent

Additional Inclusion Criteria for groups 1 and 2:

* Infants who, at the time of recruitment, have already passed the diet with a majority or exclusive formula for medical reasons, by decision of the parents or any other reason agreed with the pediatrician.

Additional Inclusion Criteria for group 3 (breastfeed infants):

* Infants who have been breastfed until the second month with exclusive or majority breastfeeding.
* Infants who are expected to be exclusively or predominantly breastfed up to 6 months.

Exclusion Criteria:

* Simultaneous participation in other clinical trials.
* Infants suffering from gastrointestinal disorders (allergy and/or intolerance to cow's milk protein or lactose).
* Mother's pathology history and during gestation: neurological diseases, metabolic disorders, type 1 diabetes mellitus, chronic disease (hypothyroidism), maternal malnutrition, TORCH syndrome.
* Treatment of the mother's anxiolytics or antidepressants. Other treatments with drugs potentially harmful to neurodevelopment.
* Inability of the parents to follow up the study (medical decision).
Lid Wiper Epitheliopathy Trial

The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.

This study will be conducted in two stages. In Stage 1, participants will wear either spectacles or contact lenses for two weeks to determine the impact of interruption of contact lens wear on LWE. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and LWE and ocular discomfort will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Sign Informed Consent document.
* Severe lid wiper epitheliopathy (upper lid) in either eye.
* Currently wearing spherical daily disposable soft contact lenses or daily wear soft contact lenses in both eyes with at least 3 months of contact lens wearing experience.
* Symptomatic as determined by the SPEED questionnaire.
* Willing to follow visit schedule.
* Habitual contact lens power with the range of -1.00 to -6.00 diopters (D) with best corrected distance visual acuity greater than or equal to 20/25 in each eye.
* Astigmatism less than or equal to 0.75D.
* Possess spectacles which provide visual acuity of at least 20/25 in each eye.
* Willing and able to complete daily diaries.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury within 12 weeks immediately prior to enrollment.
* Any ocular condition that would contraindicate contact lens wear.
* Any use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator.
* Currently wearing toric or multifocal soft contact lenses.
* Participation in a clinical study (including contact lens or contact lens care product) within the previous 30 days.
* Routinely sleeps in lenses for at least 1 night per week.
* Other protocol-defined exclusion criteria may apply.
Gamified App on Increasing Physical Activity and Reducing Anxiety in Autism

Background: Physical activity (PA) has an impact on physical and mental health in neurotypical populations, and addressing these variables may improve the prevalent burden of anxiety in adults with autism spectrum disorder (ASD). Gamified mobile apps using behavior change techniques present a promising way of increasing PA and reducing sedentary time, thus reducing anxiety in adults with ASD.

Objective: This study aimed to compare the effectiveness of a gamified and behavior change technique-based mobile app, PuzzleWalk, versus a commercially available app, Google Fit, on increasing PA and reducing sedentary time as an adjunct anxiety treatment for this population.

Methods: A total of 24 adults with ASD were assigned to either the PuzzleWalk or Google Fit group for 5 weeks using a covariate-adaptive randomization design. PA and anxiety were assessed over 7 days at 3 different data collection periods (ie, baseline, intervention start, and intervention end) using triaxial accelerometers and the Beck Anxiety Inventory. Group differences in outcome variables were assessed using repeated-measures analysis of covariance, adjusting for age, sex, and BMI.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported medical diagnosis of anxiety or self-identification of experiencing anxiety symptoms for the past 3 or more months
* Access to a supported device (smartphones with Android 4.4 and higher or iOS 9.0 and higher operating system)
* Cognitive ability to understand the purpose of the study
* No prior experience using the PA mobile apps used in the study

Exclusion Criteria:

* Individuals with low cognitive function, co-occurring intellectual disabilities, or mobility impairments
Efficacy of Augmentation of Cognitive Behavioral Therapy With Transcranial Direct Current Stimulation for Obsessive-Compulsive Disorder (OCD)

This study aims to evaluate the feasibility and clinical outcome of the Exposure-based Cognitive-Behavioral Therapy (CBT) concurrent with Transcranial Direct Current Stimulation (tDCS) in treating obsessive-compulsive disorder (OCD) patients, and explores the potential neural mechanisms of treatment effect by magnetic resonance imaging (MRI) and electroencephalography (EEG).

The current study aims to evaluate feasibility and clinical outcome of exposure-based CBT（ERP）combined with tDCS over the prefrontal cortex (mPFC) in treatment of OCD patients. 60 OCD patients whose symptom were mainly associated with "contamination/clean" will be randomized into two groups (i.e. ERP+active tDCS or ERP+sham tDCS stimulation). Over a two-month period, all patients are received 10 sessions of individual CBT, including 8 sessions of concurrent tDCS with ERP (tDCS+ERP). Three independent evaluators will rate the severity of patients' obsessive-compulsive symptoms using Y-BOCS at four assessment points: baseline (prior to the treatment), after the first (session 2#), fourth (session 5#), and eighth treatment of tDCS+ERP (session 10#). The patients will also receive MRI scan and EEG.

The current study aims to explore whether the administration of online tDCS together with ERP (tDCS+ERP) will improve the efficacy of ERP and tries to provide some early evidience that reveal potential neural mechanisms of the treatment.

Eligibility Criteria:
We recruited outpatient adults with OCD confirmed by the Mini-International Neuropsychiatric Interview (MINI). The following inclusion and exclusion criteria were also applied:

Inclusion Criteria:

(1) 18-50 years old, with at least 9 years of education, (2) Y-BOCS score ≥16, (3) no history of serious medical, neurological illness or other psychotic disorders other than OCD (anxiety or mild to moderate depression secondary to OCD was not exclusionary), (4) medication-free or had received stable medication for at least 2 months before entering the study and continued the same medication throughout the study (5) no previous exposure to ERP or tDCS.

Exclusion Criteria:

* history of serious medical, neurological illness or other psychotic disorders other than OCD
* The inability to receive tDCS because of metallic implants, or history of seizures，or history of head injury, or history of neurosurgery.
* Participants who have received ECT, rTMS, tDCS and CBT in the past.
* Participants with claustrophobic, heart pacemaker, mechanical heart valve, mechanical implant such as an aneurysm clip, hip replacement, or any other pieces of metal that have accidentally entered their body.
* serious suicide risk