cyrilzakka/clinical-trials huggingface dataset:
Effect of "Kangaroo Mother Care" on Premature Infants Physiological Outcomes

This project aims at testing the effect of applying the KMC on the premature infants' physiological outcomes. The findings of this project are expected to contribute to the discipline of preterm infants' care by providing evidence of the benefits, barriers, and facilities of providing the KMC in our Jordanian NICUs.

Premature infants are often unable physiologically to adapt well to the stressful environment of the NICU. These neonates are commonly at risk for the development of short and long term outcomes ranging from mild developmental delay to severe disability. The Kangaroo mother care approach (KMC) is developed to minimize the effect of prematurity and the NICU environmental stressors on premature infants. This project aims at assessing the neonatal nurses' knowledge and attitudes of the application of the KMC approach in the neonatal intensive care unit (NICU), testing the effect of applying the KMC on the premature infants' physiological outcomes, and exploring the mothers' lived experiences of providing KMC for their premature infants. The findings of this project are expected to contribute to the discipline of preterm infants' care by providing evidence of the benefits, barriers, and facilities of providing the KMC in our Jordanian NICUs.

Eligibility Criteria:
Inclusion Criteria:

* all stable preterm or low birth weight infants (stable infants are those who are able to breath unassisted and have no major health problems (WHO, 2003)), weighing more than 1800gm, who are admitted to the NICUs at the time of study and whose mothers consent to participate and willing to practice the KMC with her infant

Exclusion Criteria:

* high risk preterm or low birth weight infants.
Banking of Chronic Lymphocytic Leukemia Tumor Cells for Vaccine Generation

The purpose of this research study is to collect, freeze and store leukemia cells from the blood or bone marrow of patients that have advanced chronic lymphocytic leukemia (CLL) that is not in clinical remission. This study is a companion study to DF/HCC clinical trial 06-196 in which the participants' own CLL cells may form part of a vaccine treatment for their leukemia.

* It is important to understand that even if the participant consents to allow us to save their leukemia cells, we cannot guarantee that they will be able to receive a vaccine. First, we may not be able to make enough vaccine from the collected cells. Second, they may not be able to participate in a vaccine study in the future for reasons related to the status of your overall health. Third, an appropriate vaccine trial may not be available in the future.
* In order to make the vaccine, leukemia cells will be collected by one or more of the following methods: drawing blood during one of two visits to the clinic; leukapheresis; bone marrow aspiration; or, surgery to remove a lymph node.
* The physician will discuss with the participant which approach is best in their case to ensure the highest number of tumor cells collected.

Eligibility Criteria:
Inclusion Criteria:

* Ability to harvest CLL cells from peripheral blood, lymph nodes or bone marrow, defined as \> 30% involvement of bone marrow intratrabecular space, or peripheral blood lymphocytosis \> 5000/microliter, or surgically accessible lymph nodes of greater than or equal to 2cm.
* ECOG performance status 0-2
* 18 years of age or older

Exclusion Criteria:

* Uncontrolled infection
* Leukemia with active CNS involvement
Evaluation of Immune Signaling Networks in Healthy Human Volunteers

The purpose of this study is to better understand whether and to what extent the activity of immune cells in blood varies over time under normal conditions as assessed in healthy subjects. Results of this study will provide the foundation for helping us evaluate changes in immune cell activities in response to surgery and drugs used in anesthesia. The overall purpose of our research is to understand immune health in the context of anesthesia and surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-50
2. Good general health

Exclusion Criteria:

1. Recent cold or flu
2. Chronic use of medications affecting the immune system
3. Chronic illness
4. Smoking habit
5. History of drug abuse
6. Current recreational drug use
Bilateral External Oblique Intercostal Plane Block in Post Operative Pain Management in Hepatectomy

The majority of cases undergoing hepatectomy suffer from inadequate postoperative analgesia. Therefore, multimodal analgesic techniques are required to relieve pain and discomfort such as intravenous, and epidural analgesia, and peripheral nerve blocks. Although epidural catheters are efficient to provide perioperative analgesia, in this type of surgery patients may be more susceptible to catheter related complications due to the alteration in coagulation parameters. That is why safer alternatives are sought for those patients. The use of patient-controlled analgesia (PCA) for postoperative pain management improves patients' quality of recovery. However, there are many concerns regarding the type of opioids used in PCA such as overdosing, underdosing, and the effect of the hepatectomy on the drug metabolism in those patients. External oblique intercostal plane block (EOI block) is a relatively novel block used in upper abdominal incisions especially subcostal laparotomy to provide intraoperative and postoperative analgesia.

This study aims to compare the efficacy of Bilateral External Oblique Intercostal Plain Block versus PCA in pain management and reduction of opioid use in hepatectomy surgery done by subcostal incision.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 65 Years.
* Both sexes.
* Patients will be scheduled for hepatectomy surgery.
* Body mass index (BMI) 18.5-30.0 /m 2 .

Exclusion Criteria:

* Extension of the surgical incision beyond coverage of T12 dermatome.
* Prolonged time of surgery \&gt; 5 hours.
* Hepatectomy surgery combined with another organ resection.
* Patients with hypersensitivity to local anesthetics.
* History of psychiatric problems.
* Recent history of analgesic drugs including opioid abuse or addiction.
* Coagulopathy (International normalized ratio \[INR\] \&gt; 1.4).
* Localized infection at the block site.
* Morbidly obese patients.
The Feasibility and Efficacy of an Immersive Virtual Reality Software in Parkinson's Disease Patients

The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures (dolphin, orca, axolotl). Video games lead to high levels of motivation and arousal, provide immediate feedback and playback, provide explicit reward and implicit success, and titrate difficulty levels. This encourages the practice of exercise, being an important complement to physiotherapy sessions.

The main goal of this study is to evaluate the feasibility, safety and efficacy of an immersive virtual reality software (Dolphin, 2.0) in Parkinson's disease symptomatic control, in a two-arm, randomized, single-blind (blind rater for primary and secondary outcomes), delayed-start feasibility and efficacy trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Parkinson's disease according to MDS criteria;
* Hoehn and Yahr stages between I-III (MED ON);
* Ability to perform the Time Up and Go test in normal pace and without assistance, in less than 11,5 seconds in ON state;
* Stable medication for the past 1 month
* Ability to communicate with the investigator, to understand and comply with the requirements of the study;
* Willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

* History of falls (1 fall in the 3 previous months);
* Psychiatric major co-morbidity (e.g., major depressive disorder as determined by DSM IV criteria);
* A Montreal Cognitive Assessment (MoCA) score \< 21;
* Significant visual or visual-perceptual deficits or neuropsychological impairments that may limit participation in the protocol;
* Having any other neurological/orthopaedic disorders likely to affect gait or exercise capacity, e.g., history of stroke;
* Unstable medical condition including cardiovascular instability in the past 6 months
* Interfering activities performed at high level (sports);
* Inability to correctly respond to the assessment protocol according to the clinician's judgment or lack of support from caregiver for this effect.
Efficacy of Esomeprazole for Non-Allergic Rhinitis: A Double-blind, Placebo Controlled Trial

The purpose of this study was to see if high dose esomeprazole (40mg bid) was effective in treating non-allergic rhinitis


Eligibility Criteria:
Inclusion Criteria:

* age between 18-80, symptoms of perennial rhinitis, negative epicutaneous skin testing to a panel of common aeroallergens, and ability to speak English

Exclusion Criteria:

* pregnancy or breast-feeding, evidence of positive skin tests to a common aeroallergen, treatment with a proton pump inhibitor within the month prior to enrollment, treatment with any other anti-reflux therapy within the last month on a daily basis or within the last two weeks on an as needed basis, and other gastrointestinal disorders leading to reflux symptoms
Vitamin D, Cardiac Surgery and Outcome

We will use a retrospective data analysis to evaluate the association of vitamin D status with clinical outcome in cardiac surgical patients. The occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. In addition, we will assess the association of vitamin D status with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according to vitamin D status.

In a retrospective data analysis, we will evaluate the association of vitamin D status (circulating 25-hydroxyvitamin D) with MACCE (major cardiac or cerebrovascular event) in cardiac surgical patients. The occurrence of several postoperative adverse events such as myocardial infarction, low cardiac output syndrome, stroke and in-hospital death will be assessed from cardiac surgery to discharge. Approximately 4,500 data sets from January 2010 until the end of 2011 will be analyzed.In all patients, we will also assess the association of vitamin D status with the duration of mechanical ventilatory support and intensive care unit stay from cardiac surgery to discharge. Moreover, in-hospital stay will be assessed according to vitamin D status.

Eligibility Criteria:
Inclusion Criteria:

* cardiac surgical patients aged 18 years and older

Exclusion Criteria:

* age \< 18 years
* heart transplant recipients
* pacemaker or defibrillator implantation
Safety and Initial Efficacy Study of the Vortx Rx for Treatment of Benign Prostatic Hyperplasia (Canada)

The HistoSonics' Histotripsy BPH Device, the Vortx Rx, is a portable ultrasound therapy device. The purpose of this study is to assess and monitor the performance of the Vortx Rx for initial safety and efficacy for the treatment of Benign Prostatic Hyperplasia.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of BPH and eligible for endoscopic BPH surgery including Transurethral Resection of the Prostate \[TURP\], PVP, electrovaporization
2. Prostate volumes 30 - 80 gm based on transrectal ultrasound
3. Men ≥ 50 years of age
4. IPSS symptom score \> 15 and IPSS bother score \> 2
5. Baseline peak flow rate Qmax \< 12 cc/s on two separate occasions with voided volume at least 150 cc

Exclusion Criteria:

1. History of prostate or bladder cancer, pelvic radiation, untreated bladder stones, urethral strictures/bladder neck contracture (BNC), renal insufficiency (i.e. creatinine \> 1.4)
2. Neurogenic bladder, Parkinson's disease
3. Prior treatment for urinary incontinence
4. Micturition frequency AND urgency. Micturition frequency defined as \> 8 micturitions per 24 hours as assessed by a thorough subject history including the question: "On average, how many times do you void during a 24 hour period? // \< 4, 5-7, 8 or more." Urgency defined as an uncontrollable urge to void that occurs \> 3 per 24 hours as assessed through the subject history/question: "On average, how many times a day do you have an uncontrollable urgency to void? // 0, 1-2, 3 or more?"
5. Intravesical prostate lobe protrusion \> 1 cm on TRUS. Note: this is distinct from lateral lobes protruding up to the bladder such as an intravesical protrusion without median lobe
6. Active Urinary Tract Infection \[UTI\] (i.e. must have a screening urinalysis without signs of infection or a negative urine culture)
7. PVR \> 250 at time of enrollment or catheter dependent bladder drainage
8. History of chronic prostatitis within the last 5 years
9. Not able to temporarily discontinue aspirin, Coumadin, Plavix and any other anticoagulant at least seven days prior to the time of treatment
10. History of known bleeding disorders (e.g. von Willebrand disease)
11. Prior BPH prostate procedures (e.g. Transurethral Microwave Therapy \[TUMT\], TUNA, water induced thermotherapy, TURP, PVP)
12. Men with confirmed or suspected malignancy of the prostate based on a digital rectal exam (DRE), prostate biopsy or PSA \> 10 ng/mL. Men with free PSA \< 25% and with PSA within an age and race-specific range may only be enrolled after a negative biopsy. If a biopsy is required, the subject shall have a six-week waiting period between the biopsy and histotripsy treatment, if he is deemed eligible to participate in the study.
13. Men interested in future fertility
14. Declines or unable to provide informed consent
15. Non-English-speaker
16. Life expectancy estimated to be less than one year
17. Unable or unwilling to complete all required questionnaires and follow-up assessments
18. In the opinion of the investigator, it is not in the subject's best interest to participate in the study.
KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka

The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation protocol in treating traumatized children when applied by locally trained teacher counsellors as well as the effectiveness and adequacy of such a treatment in a south-asian war affected stayee child community.

Outcome measures include PTSD symptom score, Depression score, Suicidal ideation and related functioning measures (including school grades)

Eligibility Criteria:
Inclusion Criteria:

* all children with PTSD Diagnosis from six surveyed schools in Vallikamam/Jaffna educational zones age range 11-15

Exclusion Criteria:

* none
The Additive Analgesic Effects of Transversus Abdominis Plane Block in Abdominoplasty Under Spinal Anaesthesia

The primary outcome is the time to first request of opioid analgesia. The secondary outcomes are intraoperative analgesic needs, incidence of conversion to general anaesthesia, the total opioid dose in 24 hours, Visual analogue scale (VAS) scores at 2, 4, 6, 12, and 24 hours postoperatively, and the incidence of postoperative side effects (nausea, vomiting, hypotension, bradycardia, and pruritic).

Abdominoplasty is designed to remove fat, skin laxity, and excess skin with the abdominal skin flap. It is a moderately invasive extraperitoneal procedure with or without liposuction. Ambulatory office-based abdominoplasty procedures have recently increased owing to lower cost and global availability of plastic surgeons in addition to better and safer anaesthetic techniques Spinal anaesthesia has many advantages such as pre-emptive analgesia, better control of pain, suppression of the surgical stress response, preservation of perioperative immune function, preservation of oxygenation and pulmonary functional residual capacity and improved visceral vascular flow in addition to reduction in the incidence of venous thrombotic disease and hence pulmonary embolism, as it facilitates early ambulation The addition of adjuvant drugs to local anesthetics and augmenting spinal anesthesia with peripheral nerve blocks would provide time for prolonged surgeries, and it is the ideal technique for procedures below T3-T4. The investigators assume that performing a transversus abdominis plane block (TAP block) just before spinal anesthesia in abdominoplasty would prolong the duration of postoperative analgesia and lessen the number of cases needing sedation or conversion to general anesthesia when compared to spinal anesthesia alone.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists physical status grade I and grade II.
* Age \> 18 years and less than 65 years.
* Both sexes.

Exclusion Criteria:

* Patient refusal.

  -. Bleeding or coagulation abnormality.
* Local skin infection and sepsis at site of the block.
* Known hypersensitivity to the study drugs.
* Body Mass Index \> 50 Kg/m2.
a-Klotho in Relation to Calcification in the Coronary Arteries and Aortic Valve in Patients With Chronic Kidney Disease

To define the correlation of the levels of a-Klotho with the severity of vascular calcification in the coronary arteries and aortic valve.

Vascular calcification is a well-defined risk factor for cardiovascular disease and a-Klotho has been suggested to be an implicating factor in the process of vascular calcification, particularly in patients with chronic kidney disease (CKD).

With this study the investigators will examine the possible correlation of the levels of secreted a-Klotho with the severity of vascular calcification in the coronary arteries and aortic valve in patients with CKD at different stages of CKD. More precisely, a-Klotho was measured in 30 patients with end-stage renal disease under intermittent regular hemodialysis and 30 outpatients with stable CKD stage III (estimated glomerular filtration rate between 30 and 59 mL/min/1.73\^2).

Participants in both groups were eligible only if stable for at least the last 3 months pre-enrollment. Calcification will be calculated using the well-established Agatston score after submitting all patients to multi-slice computed tomography.

Continuous variables will be described as median (25th-75th percentile) and categorical variables as N (%). Variables will be compared between groups using the non-parametric Mann-Whitney U test for continuous and Fisher's exact test for categorical variables. Bivariate correlations of a-Klotho levels with clinical variables and calcification scores using the Spearman correlation coefficient will be examined. Identification of a-Klotho determinants, log-transformation of a-Klotho levels was done because of log-normal distribution and stepwise linear regression was used, with probability to remove the variable\>0.1. Identification of determinants of coronary and aortic calcification was done via log-transformation of the corresponding calcium scores, (a value of 0 was assumed; log-transformed-1 for absent calcium) and, stepwise linear regression was used as above. Because of the small sample size, all regression estimates, and confidence intervals were calculated with re-sampling so that robust variable selection and stable estimates can be ensured.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable chronic kidney disease stage V under intermittent hemodialysis and, patients with stable chronic kidney disease stage III

Exclusion Criteria:

* Active cancer
* Inflammatory or granulomatous disease
* Primary hyperparathyroidism
* Patients unable to provide informed consent
The Effect of Daily Living Activities Mobile Application Developed for Individuals With Chronic Mental Disorder on Functionality

The study was conducted to evaluate the functionality of a mobile application programme developed to help individuals with chronic mental disorders plan and implement their daily activities and its impact on activities of daily living.

The main questions it aims to answer are:

Does the activities of daily living mobile application programme improve participants' activities of daily living? Does the activities of daily living mobile application programme improve the activities of daily living? Does the activities of daily living mobile application programme improve participants' medication adherence?

This study was conducted to evaluate the effect of a mobile application program developed to enable individuals with chronic mental disorders to plan and implement their daily activities on their functionality, daily activities, and medication adherence.

The study was designed as an experimental study with a control group, including pre-test, post-test, and follow-up measurements. A total of 64 patients with chronic mental disorders who met the inclusion criteria were included in the study, with 32 in the intervention group and 32 in the control group. Data were collected using the Introductory Information Form, the Social Functioning Assessment Scale (SFAS), the Lawton Instrumental Activities of Daily Living (IADL) Scale, and the Morisky Medication Adherence Scale (MMAS). Participants in the intervention group were administered the Activities of Daily Living-Based Mobile Application Programme developed in this study.

Eligibility Criteria:
Inclusion Criteria: - Individuals diagnosed with schizophrenia and bipolar disorder according to DSM-V

* Individuals aged between 18 and 65
* I've been in treatment for the last 3 months
* Can speak and understand Turkish
* Open to communication and co-operation
* Those who did not get 0 points from the phone usage step of the Lawton IADL (Lawton instrumental activities of daily living scale) data collection tool
* Android phone owner

Exclusion Criteria:

* Hearing, vision, speech and comprehension problems
* Individuals who did not attend the two scheduled sessions
Fluid Intake Application to Reduce Kidney Stone Risks

The purpose of this investigation is to prospectively evaluate the benefit of different methods of educating patients regarding their fluid intake through a readily available daily cellular phone application to improve overall urine output and reduce risk factors for stone recurrence.

The prevalence of kidney stone disease in the United States is increasing. Recurrence of kidney stone disease has been reported as high as 50% at five years. Urine supersaturation is a predominant factor in the formation of crystallization and stone disease and is dependent on fluid volume. High fluid consumption that dilutes the urine has been shown both in vitro and in clinical studies to reduce the tendency for stone crystallization as well as effectively decrease stone recurrence. As a result, water intake greater than two liters per day is a common initial therapy for prevention of stone disease. However, studies have shown that despite physician counseling most patients are only able to modestly increase their urine volume through fluid intake. This finding may be due to a discrepancy in patient perception of their actual fluid intake and resulting urine volume. The purpose of this investigation is to prospectively evaluate the benefit of different methods of educating patient regarding their fluid intake through a readily available daily cellular phone application to improve overall urine output and reduce risk factors for stone recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years old
2. Seen in urology or nephrology clinic at UNC with a diagnosis of kidney stone
3. Prior 24-hour urine result with volume less than 2 to 2.5 liters

Exclusion Criteria:

1. Patient without cellular phone capable of utilizing Android / Apple application
2. Patient already using some form of monitoring fluid intake / volume
3. Inability to take fluid by mouth
4. Patient with urinary diversion, chronic diarrhea, bowel diversion or other forms of excessive fluid loss
5. Inability to obtain informed consent
6. Non-English speaking