cyrilzakka/clinical-trials huggingface dataset:
Virginia Commonwealth University Stress Reduction Study

This research study seeks to understand how stress reduction training influences neural responses (brain activation) and behavior related to stress, including emotions and reactions to social conflict.

The full research project will be conducted over approximately 2-3 weeks, and will consist of two data collection sessions, one before and one after a 14-day stress reduction training course conducted via a smartphone that participants provide. This course entails instructor-facilitated stress reduction exercises previously shown to reduce stress and improve well-being. Participants will be randomly assigned to a mindfulness course or a cognitive reappraisal course. Both of these courses -mindfulness training (MT) and cognitive reappraisal training (RT) - involve expert-facilitated mental wellness techniques. MT emphasizes mindfulness-based techniques to reduce stress and promote wellbeing, whereas CT emphasizes reframing and reappraisal techniques to reduce stress and promote well-being.

Eligibility Criteria:
Inclusion Criteria:

* Stable medication regiment for 8 weeks prior to enrollment if taking antidepressant or anxiolytic medications. (will not be advertised but screened)
* Free of major, uncorrected sensory impairments and cognitive deficits
* Free of a certain psychiatric disorders or history thereof; specifically, a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months, report a hospitalization over the last 3 months, report current drug abuse (e.g., recreational drug use, alcohol intake in excess of 2 drinks per day).
* Adults aged 18 - 55 years of age
* Right hand dominant (will not be advertised but screened)
* Personal SmartPhone (Android or iOS operating systems).
* Naive to meditation practice (will not be advertised but screened)
* At least a moderate level of perceived stress (scale score \> 5 on the 4-item Perceived Stress Scale (PSS; reflects above-average perceived stress)

Exclusion Criteria:

* left-handed
* are unwilling or unable to complete study assessments or treatments
* report a new diagnosis of a (non-acute) medical or psychiatric condition within the last 3 months
* report a hospitalization over the last 3 months
* report current drug abuse (e.g., recreational drug use, smoke more than � pack per day, alcohol intake in excess of 2 drinks per day)
* are prisoners
* no personal SmartPhone (Android or iOS operating systems)
Native Tissue Repair in Pelvic Organ Prolapse -Long-term Results and Risk of Re-operation

This study evaluates the recurrence of pelvic organ prolapse and the rate of re-operation after primary surgery for anterior vaginal wall prolapse with native tissue repair in long term follow-up.

This was a retrospective cohort study including patients undergoing their first surgical intervention for pelvic organ prolapse in Turku University Hospital gynecology department in the years 2000-2005. The point of interest was to study patients with prolapse of the anterior vaginal compartment (i.e. cystocele) with native tissue repair surgical approach as treatment. We made a search from the medical database of surgical procedures for operation codes LEF00 (i.e.anterior colporraphy and LEF13 (i.e. vaginal hysterectomy of descended uterus with/without vaginal/perineal molding) during the studied period. Initially, we found 699 patients with matching operating codes and for those, we went through their medical records. From the final study population, we excluded those who had previously had an operation for pelvic organ prolapse and those whose primary operation didn't include anterior colporraphy and those who weren't eligible for long term follow-up. Thus, the study population constituted of 392 subjects who were followed through medical records until the end of October 2018.

From the medical records, we collected the day of birth, the date of the primary operation, body mass index, history of vaginal childbirth and cesarean section (if available), history of incontinence surgery, the grade of cystocele and diagnosis and before surgery, the operation code and executed surgical procedures, possible complications, and the history of possible re-operations. Also, the date of death was reported as well as the date of changing residence outside the Hospital District of Varsinais-Suomi.

All gathered information were saved without personal details.

Eligibility Criteria:
Inclusion Criteria:

* cystocele treated with native tissue surgery, medical records reaching until the end of follow-up period

Exclusion Criteria:

* history of previous pelvic organ prolapse surgery
Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology

Cirrhotic cardiomyopathy is associated with increased risk of complications like hepatorenal syndrome, refractory ascites, impaired response to stressors including sepsis, bleeding or transplantation, poor health related quality of life and increased morbidity and mortality. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre.

The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality.

In this project the investigators will screen critically ill patients with cirrhosis admitted to the intensive care unit for presence of cirrhotic cardiomyopathy and perform point-of-care echocardiography, electrocardiography, and cardiorenal biomarker tests for determination of outcomes in CCM. In patients who do not survive, the cardiac histology will be assessed by ultrasound guided myocardial biopsy to assess degree of inflammation and fibrosis in CCM.

Eligibility Criteria:
Inclusion Criteria:

* Patients with cirrhosis who have been diagnosed by clinical, biochemical, histological (when available) criteria plus ultrasound imaging will be included if they meet the following:

  * Age range of 18-65 years
  * Cirrhosis with critical illness admitted to the Liver Intensive Care Unit

Exclusion Criteria:

* Age \>65 years
* Chronic renal disease
* Pregnancy and peripartum cardiomyopathy
* Valvular heart disease
* Sick sinus syndrome/ Pacemaker
* Transjugular intrahepatic porto systemic shunt (TIPS) insertion
* Hepatocellular carcinoma
* Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males at the time of assessment
Lifeflight: Fentanyl Versus Morphine

The study is exempt from informed consent by the MetroHealth Medical Center institutional review board (IRB), because two standards of care are used and there is no increased clinical risk to the patient due to the study. The researchers randomize either fentanyl or morphine to be given to trauma patients and record how their pain scale is treated along with observing for adverse events. They are looking to see if the hypothesized benefits of fentanyl (which is much more expensive than morphine) actually exist.

Periodic reports are made to the IRB.

Eligibility Criteria:
Inclusion Criteria:

* Trauma patient
* Able to speak/communicate a pain scale

Exclusion Criteria:

* Age \<18
* Age \>69
* Initially or any time hypotensive
* Prisoner
First in Human Study of UCT-03-008 in Participants With Advanced Solid Tumors

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of UCT-03-008 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Advanced solid tumor
* Measurable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function

Exclusion Criteria:

* Has not recovered \[recovery is defined as NCI CTCAE, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
* Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of UCT-03-008
* Progressive or symptomatic brain metastases
* Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
* History of significant cardiac disease
* History or current evidence/risk of retinopathy
* History of myelodysplastic syndrome (MDS) or AML
* History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
* If female, is pregnant or breastfeeding
Impact of Dental Anxiety Coping Module on Children with Dental Anxiety

The aim of this study is to evaluate the impact of the Dental Anxiety Coping Module (DACM) in children with dental anxiety. The main questions to answer are:

1. Will the Dental Anxiety Coping Module has any effect on dental anxiety in primary school children based on MY-ACDAS and HRV-Biofeedback?
2. Is there any difference in dental anxiety between control and intervention group on baseline and post-test measured with MY-ACDAS?
3. Is there any difference in dental anxiety between control and intervention group on baseline, during and post-test measured with and HRV-Biofeedback?

Dental Anxiety Coping Module (DACM) is a combination of Dental Tour and Expressive Art Therapy. Participants will be randomised into 2 groups, Control group and Intervention group (with DACM). Control group will have dental procedure without any intervention. While the Intervention group will start with dental tour where they will be shown around the dental clinic followed by Expressive Art Therapy where they will have collage and finger painting done. After DACM, participants will continue with the same dental procedure as the control group.

Eligibility Criteria:
Inclusion Criteria:

* Malaysian child, age 7 to 11 years old that understand basic Malay and English language.
* Children that fulfil both MY-ACDAS score 26 and above and HRV-Biofeedback of very low coherence score (incoherence).
* Children with American Society of Anaesthesiologists (ASA) I and ASA II classification.

Exclusion Criteria:

* Children requiring emergency treatment such as pain, facial cellulitis, and trauma cases.
* Child with learning disabilities, hearing, or visual impairment, developmental or intellectual disability and cognitive impairment.
* Parents/guardians who refuse to allow their child to participate in this trial.
Exhaled Nitric Oxide in Asthma Management

This study will compare the absolute and relative effectiveness of managing real-life asthma with and without the use of NIOX MINO® and NIOX Flex® to measure exhaled nitric oxide (eNO) as a marker of underlying airway inflammation to guide appropriate management. As exhaled nitric oxide responds rapidly to environmental changes and can act as a marker of underlying inflammation it is proposed that incorporating eNO monitoring into routine asthma management treatment allows strategies to be more accurately tailored to the patients needs, increasing the probability of good asthma control.


Eligibility Criteria:
Inclusion Criteria:

1. Aged: 6-80 years
2. Evidence of active asthma (diagnostic code and/or ≥6 prescriptions for asthma therapy at any time in their records)
3. Evidence of current asthma treatment (≥2 asthma prescriptions during baseline year and outcome year)
4. Have at least one year of up-to-standard (UTS) baseline data and at least one year of UTS outcome data (following the IPD)

Exclusion Criteria:

1. Had a COPD read code at any time; and/or
2. Had any chronic respiratory disease, except asthma, at any time; and/or
3. Patients on maintenance oral steroids during baseline year
4. Smoker or ex-smoker aged over 60
Evaluation of Laser and Tranexamic Acid in Treatment of Melasma

Melasma Is an acquired, chronic, recurrent, symmetrical hypermelanosis, which is characterized by brown patches of variable darkness on sun exposed areas of the body. It is more common in women. It is common psychologically and emotionally distressing cosmetic problem in affected patients .

Many studies examined multiple treatment options for melasma , but none of them is completely satisfactory with recurrence in most cases.

Tranexamic acid is is a relatively new drug for melasma . It is currently used via a spectrum of delivery routes including oral, topical, intradermal, and microneedling .

Laser-assisted drug delivery (LADD) is a technique that facilitates the delivery of topical medications .

On reviewing the previous literatures, few studies have focused on therapeutic effects of combined laser and TXA (topical and intradermal) in melasma, with variations in parameters of laser, in dose, concentration, form and routes of TXA application; and in follow up duration. These studies revealed variable unproven results, and since melasma is a challenging disease, additional studies are needed to determine the optimal laser parameters and the best absorbable topical TXA formula, ensuring the best efficacy and less complications.

To the best of our knowledge, this is the first study that will use topical TXA gel as an additive effect between sessions, and to confirm the effect of laser and TXA by histopathology and immunohistochemistry.

Eligibility Criteria:
Inclusion Criteria:

* - Gender: Only female patients.
* Age: 18-50 years old.
* Type of melasma: Bilateral symmetrical facial melasma of all types.
* Fitzpatrick skin phototypes: Types III, IV and V.

Exclusion Criteria:

* - Pregnancy and lactation.
* Patients taking oral contraceptive pills, hormonal replacement therapy or isotretinoin at the time of the study or during the past 6 months. Concomitant use of anticoagulants, bleeding disorders.
* Scarring and keloid tendency, active skin infections, active HSV, and those with facial cancer.
* History of photosensitivity or photosensitizing medications such as sulfonamides and tetracycline.
* Previous history of post inflammatory hyperpigmentation.
VIBRANT Registry: Value of Information Based From Pacemaker Recordings and New Technologies

The purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers.

The purpose of this registry is to gain a better understanding of how diagnostic capabilities in four Vitatron pacemakers (Selection AFm, Clarity, C-Series, and T-Series) are being utilized for the clinical management of a general pacing population. Pacemaker information and health status is collected from all patients enrolled.

Eligibility Criteria:
Inclusion Criteria:

• Class I or Class II indication for dual chamber pacing

Exclusion Criteria:

* Has an ICD or is a known candidate for an ICD
Ankle Trauma in Children, Application of Ottawa Ankle Rules From 5 Years Old, What is the Impact

Ankle sprain in children is a very common pathology. Currently in France, a standard X-ray is done in almost all cases. However, the literature has for several years validated the consideration of the Ottawa ankle rules in children to avoid the realization of these X-rays.

Our study is an evaluation of clinical practice. The aim is to assess the impact of the implementation of a new protocol using the Ottawa ankle rules from the age of 5. In particular, radiographic sparing and absence of diagnostic error.

Main objective: To compare the rate of X-rays performed before and after implementation of the protocol in pediatric emergencies.

Secondary objectives (if applicable):

* Compare the time spent in the emergency room of patients before and after implementation of the protocol
* Evaluate the gain in terms of cost for the healthcare system
* Evaluate the adherence of caregivers to compliance with the protocol
* Evaluate the decrease in the rate of X-rays performed in different age groups.
* Evaluation of the consultation rate in the month for the same reason

Primary endpoint = X-ray rate as a % of X-rays performed on the number of children presenting to pediatric emergencies over the period studied (before implementation of the protocol in a similar period = May to October 2022 / after implementation of the protocol = May to October 2023) Secondary endpoints =

* Time spent in the emergency room in min
* Estimation of the cost for the healthcare system by taking the cost of an x-ray and evaluating the gain on the reduction in the rate of x-rays performed (number of x-rays - cost of an x-ray)
* Evaluation of caregiver compliance by measuring the number of X-rays performed outside the protocol (X-ray performed despite the absence of Ottawa criteria)
* X-ray rate by age group
* Spontaneous reconsultation rate within 1 month

Eligibility Criteria:
Inclusion Criteria:

* 5 to 18 years old
* consulting in pediatric emergency in Nancy children hospital
* for ankle injury

Exclusion Criteria:

Constitutional bone disease Polytrauma Inability to assess the patient (inebriated, altered consciousness, neurosensitive disease, intoxication) Non-acquired walking Injury more than 10 days old Patient re-consults for the same injury previously assessed in the same centre Patient with previous radiographs prior to consultation Open fracture Sensory or vascular deficit Haemophilia Metabolic disease with proven osteopenia
The Association Between Endometriosis, Obesity and nesfatin1

The association between endometriosis, obesity and nesfatin1.

All women in this study were subjected to all of the following:

1. Verbal consent was obtained.
2. History taking:

   1. Personal history.
   2. Menstrual history.
   3. Use of contraception.
   4. Use of any hormonal treatment in the three months prior to the laparoscopy.
   5. History of infertility and its duration and type.
   6. Sexual history.
   7. Past history.
3. Complete physical examination: general, abdominal and local gynecological examination.
4. Complete preoperative workout for laparoscopy was done.
5. Laparoscopy was done postmenstrual, during follicular phase. All patients gave an informed consent and were fasting for at least 8 hours prior to the laparoscopy, and general anesthesia was used for all patients.

   The pelvis and its structures were observed and checked for presence of endometriotic lesions (uterus, tubes, ovaries and ovarian fossae, uterosacral ligaments, Douglas pouch, uterovesical pouch, broad ligaments and lateral pelvic walls).

   The Endometriotic patients were then classified into stages I-IV according to the revised American Fertility Society scoring system for endometriosis.
6. Venous samples for measurement of nesfatin-1 were taken by venipuncture from patients during the laparoscopy procedure immediately after initial evaluation and before any intervention.
7. Biopsy from lesions suspected as endometriosis was taken during laparoscopy and sent to histopathology for confirmation.
8. The blood samples were centrifuged immediately after their collection at 5000 rpm for 10 min and serum samples were stored at -20 °C until analysis.

   Patients and Methods

   -67-
9. Nesfatin-1 was measured by Enzyme-Linked Immuno Sorbent Assay "ELISA" technique using commercially available kits (Boster Biological Technology Human Nesfatin-1 ELISA kits, Catalog number EK1138, USA) in the Central Labs of Ain Shams University Hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Women in reproductive age group scheduled for laparoscopy for any indication.

Exclusion Criteria:

* Women subject to any hormonal therapy in the last 3 months.
* Women with chronic endocrine disease like diabetes mellitus.
* Women diagnosed with pelvic inflammatory disease (PID).
* Severe medical disorder that prohibits the laparoscopic procedure, such as cardiovascular disease and pulmonary disease.
Orismilast for the Treatment of Mild to Severe Hidradenitis Suppurativa

The purpose of this study is to assess the efficacy and safety of oral administration of orismilast for treatment of mild, moderate, or severe hidradenitis suppurativa (HS) in adults.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female adult patients, 18 years of age or older.
2. Have mild to severe HS for at least 1 year prior to the baseline visit, as determined by the investigator through participant interview and/or review of the medical history.
3. Have HS lesions in at least 2 distinct anatomic area (right/left axillary, inguinal, inframammary, abdominal, perineal).
4. Has a total inflammatory lesions (AN) count of greater than or equal to 2.
5. Total draining fistula count of less than or equal to 30.
6. A stable analgesic dose for 2 weeks prior to baseline.

Exclusion Criteria:

1. Presence of active skin lesions other than HS that could interfere with the assessment of HS.
2. Receipt of prescription topical therapies for HS within 7 days prior to the baseline visit (Visit 2).
3. Receipt of systemic therapies for HS, within 28 days prior to the baseline visit.
4. Any oral antibiotic within 28 days prior to baseline visit.
5. Receipt of a live vaccine within 14 days prior to screening.
6. Biologic use for indications other than HS within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
7. Treatment with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives of the drug, whichever is longer, prior to baseline.
N-acetyl Cysteine and Patients with Non-alcoholic Fatty Liver Disease

Effect of N-acetyl cysteine on markers of oxidative stress and insulin resistance in patients with Non-alcoholic fatty liver disease


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18-60 years diagnosed with NAFLD

Exclusion Criteria:

* History of alcohol consumption, drug addiction or the use of medications known to precipitate steatohepatitis.
* Patients with schistosomiasis, active hepatitis B or C, autoimmune and diabetes mellitus.
* current Consumption of any antioxidant supplements and hepatotoxic drug.
* Pregnancy or lactation or expecting to get pregnant during the study.
* Medical, psychological, or pharmacological factors interfering with the collection or interpretation of study data.
* Active Cancer patients.
* Anyone having hypersensitivity to N-acetylcysteine.
* Anyone already taking N-acetylcysteine.