cyrilzakka/clinical-trials huggingface dataset:
Neuro- and Biofeedback in Nonsuicidal Self-injury

Nonsuicidal self-injury (NSSI) is defined as the direct, deliberate destruction of one's own body tissue without suicidal intent, typically including behaviors such as cutting, burning, or hitting oneself. The risk of engaging in NSSI is particularly high during adolescence. NSSI is associated with impairments in emotion regulation and NSSI behavior serves as an attempt to regulate emotion. We propose to examine whether training adolescents with NSSI to self-regulate using emotion regulation skills to down-regulate hemodynamic activity of the salience network, involved in emotional processing. Moreover, we propose to examine whether limbic-prefrontal cortex connectivity can be increased following neurofeedback, thereby helping adolescents find an optimal way to emotionally regulate with the help of neurofeedback, instead of engaging in NSSI to regulate emotions. We also aim to examine effects of real-time biofeedback by investigating if adolescents can regulate their psychophysiological activity during emotional reactivity with biofeedback. Sixty participants with NSSI will be recruited and offered either real-time functional magnetic resonance imaging (rt-fMRI-NF) (n = 30) or real-time biofeedback (n = 30) training. Participants each each condition will then be randomized to either an active or a control condition (n = 15/group). Participants will take part in three runs of feedback training. Changes in emotional reactivity as measured with facial electromyography (EMG) before and after feedback training will be the proximal outcome measure together with changes of the blood oxygenation level dependent (BOLD) response during real-time fMRI-neurofeedback for the neurofeedback training. Proximal outcome measures for the biofeedback will include psychophysiological measures of emotional reactivity (facialEMG). More distal outcome measures for both neuro- and biofeedback will be measures of NSSI: frequency, methods and severity as well as self-report measures of difficulties with regulating emotions, emotional reactivity and psychiatric symptoms.


Eligibility Criteria:
Inclusion Criteria:

* ongoing contact at the child- and adolescent psychiatric clinics in both Linköping and Norrköping, Sweden
* ongoing contact at the primary care facilities in Linköping and Norrköping (Ungdomshälsan, Råd, Stöd \& Hälsa)
* NSSI, independent of psychiatric diagnosis
* between 15 and 19 years of age
* having engaged in five or more instances of NSSI during the last six months
* the patient is cognitively capable to decide for him- or herself

Exclusion Criteria:

* anorexia in starvation with BMI 16 or under
* substance abuse disorder
* psychosis
* needing interpreter
* intellectual disability
* and for those who do the neurofeedback, severe claustrophobia, pregnancy and braces
Wound Dressings For Split-Thickness Skin Graft Donor Sites in Patients Undergoing Surgery

This study is to determine what dressing would work best to heal and keep from hurting, the split-thickness skin graft donor site which will be done as part of the patient's surgical procedure. Currently there is a dressing that is transparent and it is placed on the wound after surgery and wrapped with gauze and an elastic bandage. Two days after the surgery the gauze and elastic bandages are removed and the area is left with the transparent dressing. Sometimes the dressing needs to be changed because it leaks. On the fifth day this dressing is removed and the wound is left open to air. The dressing researchers are studying is a dressing that has been used for different types of wounds, as well as this type of wound. It is applied in the same manner; however, it is left in place until it falls off independently, usually around post-operative (post-op) day 10.

PRIMARY OBJECTIVES:

I. Which dressing type and technique is most effective in minimizing pain and inflammation and promoting epithelialization in patients who have had surgery which requires the use of an anterior thigh split-thickness skin graft?

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.

ARM II: Patients receive native collagen wound dressing after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Population of otolaryngological or surgical oncology patients experiencing an autologous split-thickness skin graft as part of their surgical procedure
* Patients will have a Glasgow Coma score of 15 (or 10 with a tracheostomy)
* Patient donor sites will be limited to the anterior thigh
* Patients will be free of documented circulatory deficits, neuropathy, or mental illness which prohibits their ability to independently consent or respond to questions regarding pain
* Patients will be able to give consent independently
* Patients will be able to read and write in English

Exclusion Criteria:

* Patients unable to give independent consent for any reason
* Skin graft donor sites other than the anterior thigh
* Patients with a concurrent diagnosis of diabetes, peripheral vascular disease, and/or paresthesias or paralysis of the lower extremities
* Patients who are unable to complete a self-report pain scale
* Patients who are prisoners
* Patients who are known active alcoholics
* Patients on steroids or other medications known to affect healing
Nurse-To-Family Telehealth

This study will be a pilot test of using telehealth to allow nurses to connect with parents/guardians of pediatric patients who are being transferred between hospitals.


Eligibility Criteria:
Inclusion Criteria:

Children who:

* are aged 8 days to \<=18 years
* present to a participating community hospital ED
* are accepted for inter-facility transfer to UC Davis
* are assigned to UC Davis unit D10, D7, or T6
* have an English-speaking adult parent/guardian at the bedside

Exclusion Criteria:

* does not have an English-speaking adult parent/guardian at the bedside

For parent surveys --

Inclusion Criteria:

* are parents/guardians of the eligible patients (described above)
* are age 18 years and older
* are English-speaking

Exclusion Criteria:

* are age less than 18 years
* have a preferred language that is other than English
Enhancing Independence Using Group-based Community Interventions for Healthy AGing in Elders: the ENGAGE Pilot Study

This study will be conducted to determine the safety and feasibility of translating a physical activity intervention (LIFE Study) into a community setting. Study outcomes include physical performance, safety, and feasibility of conducting the LIFE PA intervention in a community setting.

Older adults who lose their mobility experience a poorer quality of life, are less likely to remain independent in the community and have higher rates of chronic disease, falls and mortality. Recent results from the Lifestyle Interventions and Independence for Elders (LIFE) study demonstrated that a structured program of physical activity (PA) reduced the onset of major mobility disability in at-risk older adults by up to 28% over a 2.6 year period. Despite the public health significance of this study, to-date no study has attempted to translate LIFE PA to broader populations of at-risk older adults in community-based settings. To address this knowledge gap, and to aid the design of a larger pragmatic trial of LIFE PA in community-based settings, the investigators conducted the ENhancing independence using Group-based community interventions for healthy AGing in Elders (ENGAGE) pilot study. The investigators examined the safety and feasibility of translating LIFE PA into the existing infrastructure of a community-based senior center. The investigators also explored the preliminary real-world effectiveness of PA on physical performance and several other important health related outcomes for older persons, including cognitive function, quality of life, depressive symptoms and frequency of falling.

Eligibility Criteria:
Inclusion Criteria:

* Males and Females age ≥ 65 and ≤89 years
* Community dwelling
* Short Physical Performance Battery ≤ 9
* No participation in a structured physical activity program within the previous 3 months
* Willingness to be randomized and participate for 24 weeks
* Written permission from primary care physician
* Having obtained his/her informed consent

Exclusion Criteria:

* Acute or terminal illness
* Modified Mini-Mental State Examination Score \<80(\<76 if African American)\*
* Myocardial Infarction in the previous 6 months
* Symptomatic coronary artery disease
* Upper or lower extremity fracture in the previous 6 months
* Resting blood pressure \>180/100 mmHg
* Unable to communicate due to severe hearing loss or speech disorder
* Severe visual impairment that may preclude participation in the study assessments or interventions
* Non-English speaking
Biological Risk Factors for Onset of Binge Eating and Compensatory Behaviors

The purpose of this proposed project is to test whether several biological factors (such as elevated brain reward region and attention region response to high-calorie foods, weaker inhibitory region response to high-calorie foods, habitual caloric deprivation, and elevated limbic region responsivity) increase the risk of problematic eating (bingeing and purging) in female adolescents.

Participants will be adolescent girls aged 13-16, some of whom will have parental history of eating pathology. Participants will be recruited from the general population but their age, gender, and the presence of parental lifetime eating pathology will create a high-risk sample. The goals of the proposed project are to (1) conduct a prospective high-risk study to test whether proposed biological risk factors predict the future onset of core ED symptoms (e.g., binge eating, compensatory behaviors); (2) test hypotheses regarding how these biological risk factors and established self-report ED risk factors may work together to predict ED behavior onset; (3) examine if certain biological factors account for the effects of certain established self-reported ED risk factors (e.g., elevated brain response to thin models accounts for the effect of questionnaire-measured thin-ideal internalization). The participants will complete a baseline assessment and then follow-ups assessments over a span of three years. In addition, participants will complete one fMRI scan after the first assessment.

During the COVID-19 shelter-at-home order, the investigators will not measure in person only outcomes including fMRI scans, height and weight measurement for BMI calculation nor IAT computer paradigms for all participants that have assessments due during this order.

Eligibility Criteria:
* Inclusion Criteria:

  * Female
  * Aged 13-16 years
* Exclusion Criteria:

  * Adolescents who report functional magnetic resonance imaging (fMRI) contraindications
  * Current Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) substance abuse disorder, eating disorder (ED), conduct disorder, attention deficit hyperactivity disorder (ADHD), or bipolar disorder
  * Weekly or greater use of psychoactive drugs (e.g., analgesics, cocaine, marijuana)
  * Serious medical complications (e.g., cancer, diabetes)
  * History of head injury
  * Relevant food allergies
  * BMI \> 35
Observational Study on Efficacy and Safety of Liraglutide in Subjects With Type 2 Diabetes

This observational study is conducted in Europe. The aim of this non-interventional (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess the conditions of use of Victoza® in daily medical practice in France.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type 2 diabetes
* Patients having recently started (for less than one week) or starting liraglutide (Victoza®) treatment

Exclusion Criteria:

* Hypersensitivity (allergy) to liraglutide or to any of the excipients
* Patient is participating in a clinical trial at the inclusion
* Type 1 diabetes
Working Memory Training for Chronic Neuropathic and Fibromyalgia Pain

The goal of this project is to investigate and improve executive control function in two distinct pain conditions, namely neuropathic pain and fibromyalgia (FM). It is hypothesized that there is a significant difference in the executive control function of patients with neuropathic pain and FM pain. It is also hypothesized that all participants with poor executive control functioning will report significant improvements in pain intensity, functioning and cognitive complaints following cognitive training. The study tests and influence the working memory concepts of inhibition, updating and flexibility through an experimental, cross-over treatment design.

To perform the experiment, we will recruit 160 participants (80 with neuropathic pain and 80 with FM) from the Departments of pain management and research at St Olav's University Hospital and Oslo University Hospital (OUS). The proposed design will be able to determine whether or not executive control, processing speed and memory function differs in two distinct populations of pain patients. Moreover, whether impairments are amended by computerized training.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of fibromyalgia or neuropathic pain
* Confirmed objective cognitive impairments on the CANTAB battery compared to IQ control

Exclusion Criteria:

* Mania, suicidal ideation and/or active psychosis
* No objective cognitive impairments
* Personality disorders
* Pregnancy
Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (RADOA). Focus on New Antidots

Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need urgent interventions/operations that cannot wait are included in this registry, or during emergency operations

The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC, aPCC, rVIIa, specific antidots in patients needing urgent interventions/operations or in severe bleeding patients treated with oral anticoagulants.

By collecting case reports from several university hospitals and clinics, different treatment strategies in clinical practice will be observed and evaluated, and may serve as a comprehensive information resource for the safe management with DOA, but also with the long-term anticoagulation based on coumarin derivatives in the near future.

The current objective of this registry is to:

1. Document the clinical course and outcome of various clinical bleeding events associated with DOA or VKA in patients with severe life-threatening bleeding making intervention necessary
2. Document the clinical course and outcome of urgent surgical interventions within 24 hours after admission in patients under DOA or VKA treatment.
3. Characterisation of therapeutic strategies in stopping acute life-threatening bleeding including following agents and methods:

   1. blood transfusion,
   2. platelet concentrates
   3. reversal agents \[e.g. vitamin K, prothrombin complex concentrate (PCC), activated PCC (aPCC), activated factor VII (aVII), fibrinogen concentrate, fresh frozen plasma (FFP)\]
   4. specific antidots, e.g. idarucizumab, Andexanet alpha
   5. haemodialysis
   6. desmopressin
   7. tranexamic acid
   8. no specific treatment in respect to the above mentioned treatments (e.g. stop of medication and waiting until anticoagulant effect of DOA is decreased).

Eligibility Criteria:
Inclusion Criteria:

Group a) Bleeding patients:

* Anticoagulated patients with DOA or VKA with clinically overt major bleeding according to a specified ISTH definition for non-surgical patients:
* Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome
* Bleeding causing a fall in hemoglobin level of 2 g L-1 (1.24 mmol L-1 ) or more leading to transfusion of two or more units of whole blood or red cells.

OR

Group b) Acute surgical need patients

* treated with DOA or VKA and who need urgent operation which cannot wait (\< 24 h after last intake of drug)
* with or without reversal agent use (e.g. PCC, aPCC, rVIIa) (and/or haemodialysis for dabigatran)
* provides informed consent after the acute event

Exclusion Criteria for Group a and b:

* Conscious patient by him-/ herself or his/ her available legal representative does not agree with inclusion in the registry
* Age \< 18 years
* Concomitant participation in an interventional trial
Pelvic Floor and Sexual Dysfunction in Women with Sjogren's Syndrome

Sjogren's syndrome (SS) is a chronic, systemic, autoimmune disease characterized by lymphocytic infiltration of all exocrine glands, especially tear and salivary glands, and is more common in women.

Sexual functions are affected by symptoms such as pain, fatigue, stiffness, and hormonal imbalance in rheumatological disorders. Vaginal dryness and dyspepsia negatively affect participation in sexual activity. The aim of the study is to examine the pelvic floor problems of women with SS with a self-report, to compare them with healthy individuals, and finally to examine the relationship between pelvic floor problems and sexual dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 18-65
* being a woman,
* having sex partner,
* no smoking, no alcohol

Exclusion Criteria:

* physical, psychological, cognitive impairment,
* having a non-Sjögren additional disease,
* malignancy,
* pregnancy,
* no urogenital disease,
* sarcoidosis,
* AIDS,
* anticholinergic drug use,
* had a gynecological or urological operation other than cesarean
Study Evalutating the Pharmacokinetics (PK) and Safety of a Single Dose of Desvenlafaxine Sustained Release (DVS SR)

To assess the initial pharmacokinetic profile of single doses of 25mg and 50 mg of DVS SR to healthy subjects.


Eligibility Criteria:
* Men or non-pregnant, non-lactating women
* Body mass index 18 - 30 kg/m2
* Body weight greater than or equal to 60kg
Rheumatoid Arthritis Response to Methotrexate

Observational and prospective study of the ultrasound response to methotrexate in rheumatoid arthritis patients who started methotrexate

* Rheumatoid arthritis patients with active disease who start subcutaneous methotrexate by their rheumatologist prescription methotrexate will be included.
* Patients will participate in a prospective and observational study in which the response to methotrexate will be assessed by ultrasound (US) of joints and tendons.
* The main objective of the study is the change in B mode and Doppler mode US after 24 weeks of methotrexate treatment.

Eligibility Criteria:
Inclusion Criteria:

* Active rheumatoid arthritis fulfilling EULAR criteria.
* Prescription of methotrexate by a rheumatologist.
* Informed consent signed by the patient.

Exclusion Criteria:

* None
Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency

The purpose of this study is to evaluate the safety and effectiveness of adipose derived mesenchymal stem cells (AD-MSCs) therapy on sexual hormone deficiency in the middle-aged patients

The purpose of this study is to evaluate the safety and efficiency of adipose-derived mesenchymal stem cells in 30 patients with sexual hormone deficiency at Vinmec International Hospital, Hanoi, Vietnam

Eligibility Criteria:
Inclusion Criteria:

* Age: 35 years to 70 years (Male) and from 35 years to menopause age (Female)
* Male: decrease in libido, decrease in intercourse frequency, erectile dysfunction, Difficulty in concentration, testosterone level ≤ 12 nMol/dL
* Female: reduced or absent menstruation after radiation exposure or chemotherapy; Hot flushes, excessive sweating, and anxiety, together with other symptoms associated with the menopause, AMH level ≤ 2 ng/ml and/or FSH level ≥ 10 mIU/ml.
* Patients signed the informed consent form

Exclusion Criteria:

* Surgery removal of endocrine glands
* Abnormalities in the endrocrine glands
* Hormone deficiency due to diabetes and other metabolic disorders
* Active autoimmune diseases
* Current usage of immunosuppressive drugs
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
Machine-learning Algorithm to Differentiate Intraoperative Ketamine Dosing Based on Electroencephalographic Density Spectrum Array Analysis

Ketamine is widely used in the setting of multimodal general anesthesia, and the Electroencephalographic density spectral array (DSA) monitoring has been implemented in the practice of anesthesia. The purpose of this study is to investigate the dose-response EEG changes in patients during the perioperative period when ketamine is used. With the application of machine-learning algorithm, we aim to interpret the ketamine dosing precisely and accurately, based on the DSA obtained.

In this single-blinded randomized controlled trial, we enroll 90 patients undergoing major spine surgery, and candidates are divided into 3 groups: A (control group using sevoflurane only), B (sevoflurane + 3µg/kg ketamine infusion), C (sevoflurane + 6µg/kg/min ketamine infusion). Throughout the perioperative period, under standardized perioperative care, each patient will be monitored with EEG DSA. The data obtained will be utilized for machine-learning in the development of a algorithm to interpret the precise dosing of ketamine in respect of its effect on the EEG DSA. This study is also anticipated to boost the development of dose-response algorithm of other agents, promoting the advancement of the concept of "multimodal general anesthesia"

Eligibility Criteria:
Inclusion Criteria:

1. Patients undergoing elective spine surgery
2. Aged 20-80 years old

Exclusion Criteria:

1. Pregnancy
2. Presence of major brain disorders: stroke, epilepsy, Parkinson's disease, etc.
3. Any of the following major organ disorders:

   1. Chronic pulmonary disease (Clinically diagnosed severe chronic obstructive pulmonary disease or FEV1/FVC \<70% or FEV1 \<50%)
   2. Heart failure (NYHA III or IV)
   3. Chronic renal failure (eGFR\<60ml/min/1.73m2)
4. Ongoing sepsis or infection
5. Ongoing of history of CNS-acting medications/substances use (e.g.: sedatives, hypnotics, stimulants, etc.)
Retrospective Analysis of Hospital Medical Records on Medication and Supplement Use in Pregnant Women

Monocentric study in University Hospitals Leuven (campus Gasthuisberg).

Hospital medical records from all pregnant women who delivered between 01/07/2015 and 31/12/2015 in University Hospitals will be analyzed for the presence of medication and supplements.

Some demographic and obstetric parameters will be collected as well.

The anonymized dataset will be analyzed using descriptive statistics (Excel). There will be no intervention among the selected sample.


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women who delivered in the University Hospital of Leuven between 01/07/2015 and 31/12/2015