cyrilzakka/clinical-trials huggingface dataset:
A Study for Patients With Attention-Deficit/Hyperactivity Disorder Treated With Atomoxetine

The purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in Asian children treated with atomoxetine.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients between 8 and 11 years of age at study entry
* Attention-Deficit/Hyperactivity Disorder (ADHD) meeting the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria
* Patients who have never received medications psychotropic medications specifically to treat ADHD, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry
* Normal intelligence in the judgment of the investigator
* Must be able to swallow capsules

Exclusion Criteria:

* Current or past history of bipolar I or II disorder, psychosis, autism, Asperger's syndrome, pervasive developmental disorder, or conduct disorder
* History of seizure disorder or currently taking anticonvulsants for seizure control
* Serious suicidal risk as determined by investigator
* Cardiovascular disease; current or past history of hypertension
* Previous treatment with atomoxetine
The Efficacy of Erector Spinae Block Versus Transversus Abdominis Plane Block in Laparoscopic Nephrectomy

The investigators hypothesis that erector spinae block better than transversus abdominus plane block regarding the post operative pain management.

Aim of the work:

The purpose of this study to compare erector spinae block to transversus abdominus plane block in laparoscopic nephrectomy regarding analgesic efficacy and postoperative morphine consumption.

Statistical Analysis

I. Sample size:

Sample size was calculated using G-power software. A previous study (reference) reported that the amount of morphine used in the first 6 hours in patients received TAP block in nephrectomy was 12.4 ± 8.4. Assuming that the amount will change by 50% at least with the other block, a power of 80% and an alpha error of 0.5, the minimum sample size required will be 60 patients (30 in each group). We will increase it to 35 in each group to compensate for drop-outs. (15)

II. Statistical analysis:

All measurement indexes will be expressed as mean ± SD/standard error of the mean or number (%). After analysis of normality of data distribution, normally distributed data will be compared by the independent sample t-test. Unpaired quantitative variables will be evaluated by the Student t-test and analysis of variance. The Mann-Whitney U test will be employed for intergroup comparison, and the Wilcoxon signed-rank test for comparison between different time points within the same group. Intergroup comparison of categorical variables will be performed by the chi-square test. Values of A P value less than 0.05 will be considered statistically significant. All data will be statistically analyzed by statisticians using the SPSS 16.0 software package (IBM Corp., Armonk, NY, USA).

Eligibility Criteria:
Inclusion Criteria:

* Patient age (\>18 and \<60)
* Both sexes
* American Society of Anesthesiologists (ASA) physical status classes I and II
* Patients scheduled for laparoscopic nephrectomy surgery.

Exclusion Criteria:

* Refusal of regional block
* Patients with uncontrolled diabetes or hypertension
* Patients with neurological, psychological disorders or those lacking cooperation
* Patients with anatomic abnormalities at site of injection, skin lesions or wounds at site of proposed needle insertion.
* Patients with bleeding disorders defined as (INR \>2) and/ or (platelet count \<100,000/µL)
* Patients with hepatic disease e.g. liver cell failure or hepatic malignancy or hepatic enlargement.
* Patients who are allergic to amide local anesthetics.
* Cases converted to open surgery will also be excluded from the study
Repetitive Brake Activation

The appearance of intact macronutrients in the small intestine induces an intestinal brake; a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. Several studies showed that intraileal infusion of nutrients resulted in a reduction in food intake. However only acute effects were investigated in these studies and thus far it is not known whether repetitive (intermittent) infusion results in adaptation to repeated exposure and, thus, a lowered ileal brake response.


Eligibility Criteria:
Inclusion Criteria:

* Based on medical history and previous examination, no gastrointestinal complaints can be defined.
* Age between 18 and 65 years. A higher age comes with a higher chance of comorbidities. These could influence our study outcomes and therefore this age range was chosen. Furthermore, we think this study would be too invasive for subjects over the age of 65. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
* BMI between 18 and 25 kg/m2)
* Weight stable over at least the last 6 months (≤5% weight change)

Exclusion Criteria:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
* Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
* Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
* Dieting (medically prescribed, vegetarian, diabetic, macrobiological, biological dynamic)
* Pregnancy, lactation
* Excessive alcohol consumption (\>20 alcoholic consumptions per week)
* Smoking
* Blood donation within 3 months before the study period
* Self-admitted HIV-positive state
* Evidence of casein or hypersensitivity
Effect of Intraoperative Virtual Reality on Anxiety and Vital Findings in Patients Total Knee Replacement Surgery

Although total knee replacement surgery improves the quality of life of the patients, a significant reduction in knee pain and normalization of the knee joint, the awareness of the surrounding events is a major concern for the patients and negatively affects their vital signs, since most of the patients are awake during the surgery. When the literature is examined, there are no pharmacological methods to reduce anxiety.

When distraction techniques are used, patients' anxiety levels are significantly reduced, vital signs are normalized, patient satisfaction is increased and pain is relieved.

It has been emphasized that there is a successful method in reducing One of the distraction techniques is the application of virtual reality. This study will be carried out in a randomized controlled experimental design to determine the effect of virtual reality application during surgery on patients who will undergo total knee replacement surgery, on the anxiety level and vital signs of the patients.

The aim of this study is to determine the effect of virtual reality application on patients' anxiety level and vital signs during surgery for patients who will undergo total knee replacement surgery.

It will consist of patients over the age of 18 who will have total knee replacement surgery, which will be carried out in the Operating Room Unit. Patients meeting the sample selection criteria were randomized into experimental and control groups.

will be divided into two groups. Virtual reality glasses will be applied to the experimental group. In the collection of data; "Patient Information Form", "State Anxiety Inventory Scale" and "Vital Signs Follow-up Form" will be used.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily agreed to participate in the research
* Being 18 years or older
* Being able to read and write Turkish
* No vision and hearing problems
* Not using glasses
* Absence of any psychiatric, cognitive or neurological disease

Exclusion Criteria:

* Patients with visual or hearing impairment
* Patients receiving general anesthesia
* Those who have previously had total knee replacement surgery
Lazanda Fentanyl Nasal Spray Pre Radiofrequency Nerve Ablations(RFA) of Lumbar Facet Joints

The purpose of this study is to evaluate the effectiveness, feasibility and safety of intranasal fentanyl (Lazanda) as an alternative to the current gold standard (diazepam) to produce anxiolysis and improve patient comfort during and after radiofrequency ablations of the lumbar facet joints. If this pilot study shows a positive effect and Lazanda is found to be feasible and safe for use during procedures, future larger scale studies can be done.

The morning of the procedure/procedures the medication will be obtained from the omnicel by one of the qualified pain clinic study staff for the volunteers that have consented for that day. . It will be signed out on the designated form created for tracking and accountability purposes Patient consent for study participation will be confirmed.

Once in the procedure room a DVPRS (Defense and Veterans Pain Rating Scale) baseline pain score and POSS (Pasero Opioid-induced Sedation Scale) score will be assessed by a member of the research team. Baseline non-invasive blood pressure, heart rate, and oxygen saturation will be documented and continuous monitoring of these vital signs will commence by a provider credentialed by WAMC (Womack Army Medical Center) to perform anxiolysis with documentation every 15 minutes until discharge. A qualified RN (Registered Nurse), or physician will administer 100 mcg of Lazanda ten-fifteen minutes prior to the procedure The administration will be witnessed and confirmed on Appendix D. The unused 7 mcg will be wasted in a charcoal filled bag provided by the manufacturer and that bag will be disposed of per hospital policy. The waste will also be witnessed and noted. The Pasero Opioid-Induced Sedation Scale and a DVPRS pain score will be assessed every 15 minutes through the conclusion of the procedure and every 15 minutes up until discharge or for 1 hour post procedure whichever comes first. If naloxone is required during the procedure this will be noted as well. Any adverse or serious adverse events will be reported per regulatory regulations.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients ASA(American Society of Anesthesiologist physical classification system) I-III
* 18 years of age and older Referred for lumbar facet RFA (radio-frequency ablation) by Womack IPMC (Interdisciplinary Pain Management Center)

Exclusion Criteria:

* Known allergy to Fentanyl or naloxone
* Diagnoses of allergic rhinitis with active rhinorrhea
* Pregnant or Breastfeeding
* Asthma or COPD (chronic obstructive pulmonary disease) that requires frequent rescue medications.
* Hepatic insufficiency with abnormal liver enzymes
* Noted decreased mental function
* Heart rate under 50 or BP below 90 systolic and/or 60 diastolic
* Myasthenia gravis diagnoses
* Acute narrow angle glaucoma
* Allergy to meperidine
* On medications with a known dangerous drug interactions to Fentanyl
Real-Time (TRUS) Guidance in Endoscopic Treatment of BPH

The study aims to evaluate the role of TRUS in improving the efficacy and safety of endoscopic enucleation of prostate and TURP.

Standard TURP is an established procedure for managing BPH but has limitations, including the risk of incomplete adenoma removal and complications such as bleeding. Research on transurethral enucleation techniques has demonstrated potential for improved outcomes, especially in larger prostates. However, challenges persist in achieving precise resection boundaries and minimizing intraoperative risks.

TRUS, widely utilized for prostate biopsy and volume assessment, has recently gained attention for its intraoperative applications. Studies show that real-time TRUS provides accurate imaging of prostate anatomy and resection planes, helping surgeons better differentiate adenomatous tissue from surrounding structures. This enhances surgical precision, reduces intraoperative bleeding, and minimizes residual tissue, leading to better outcomes in procedures like TURP and enucleation.

Current TURP and enucleation approaches depend heavily on endoscopic visual guidance, which, despite significant advancements, can lead to residual tissue, excessive bleeding, and prolonged recovery. While enucleation techniques have addressed some of these challenges, they remain less accessible due to high costs and steep learning curves, making them unsuitable for all healthcare settings.

Integrating TRUS into TURP or enucleation offers the potential to address these limitations by enhancing tissue differentiation and guiding precise resection. This study aims to evaluate the efficacy of TRUS in reducing complications, achieving complete tissue removal, and improving patient recovery outcomes, potentially paving the way for its routine adoption in BPH surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 50-80 years
* Diagnosed with benign prostatic hyperplasia (BPH) and scheduled for TURP or prostatic adenoma enucleation.
* The patients have clear indication for endoscopic surgery (according to the guidelines).
* Clinically fit patients for surgery.
* Signed an informed consent.

Exclusion Criteria:

* • Prostate cancer

  * Previous urethral or prostate surgery
  * Neurogenic bladder
  * Urethral stricture
Mindful Awareness in Body-Oriented Therapy for Women's Substance Abuse Treatment

The primary purpose of this exploratory and developmental study is to evaluate a mind-body intervention for relapse prevention for women in addiction treatment. The proposed intervention, Mindful Awareness in Body-Oriented Therapy (MABT), is a novel mind-body intervention designed to enhance embodiment and to facilitate mindfulness through the combination of massage, body awareness exercises and the acquisition of mindfulness skills. The treatment goals of MABT include reduction of avoidant coping responses, increase of emotional-regulation, and decrease of trauma symptoms through access to and acceptance (vs. avoidance) of sensory and emotional experience. These are thought to be important for relapse prevention given the positive association between stress, negative affect and relapse; and risk of relapse associated with PTSD symptoms. Mind-body interventions in relapse prevention are of increased clinical and scientific interest, particularly for the potential to overcome automatic response patterns that are associated with lapse and relapse in substance use treatment. This proposal falls within the current NIDA research portfolio focus on the development of interventions that will help people better cope with stress, negative affect, and trauma.

Specific Aims:

* Aim 1: To examine feasibility of recruitment to and retention in MABT as an adjunct to substance abuse treatment. Specifically, to describe a) study enrollment and barriers to recruitment, b) sample characteristics, c) response to randomization, d) session attendance, and e) loss to follow-up.
* Aim 2: To describe MABT acceptability to study participants and substance abuse treatment staff.
* Aim 3: To compare the effect of body-oriented therapy plus treatment-as-usual vs. treatment-as-usual only on reported days abstinent for overall substance use and primary drug use among women receiving substance abuse treatment, in order to estimate the effect size. Secondary analyses will examine for intervention effects on related outcomes including days abstinence on biochemical screens for substance use, body connection indicators, avoidant coping, stress reactivity, co-morbid psychological distress, and physical well-being.


Eligibility Criteria:
Inclusion Criteria:

* Female
* enrolled in weeks 1-3 of Residence XII inpatient program
* plans continued out-patient treatment at Residence XII
* willing to sign release to contact the Residence XII mental health therapist in the case of concern regarding participant safety and well being
* willing to forgo (non-study) body therapy between baseline and post-intervention assessment (3 months)
* willing to accept random assignment to study treatment conditions

Exclusion Criteria:

* Current domestic violence
* Pregnant
A SMART Design for Attendance-based Prize CM

The purpose of this study is to compare different forms of treatment for substance abuse. This study will involve a type of treatment called contingency management, in which patients receive incentives (prizes) for attending outpatient treatment. This study will compare contingency management to standard treatment that does not involve incentives. This study will also compare contingency management treatment that lasts 6 weeks to contingency management that lasts 12 weeks. Finally, this study will compare contingency management treatment delivered at the beginning of outpatient treatment to contingency management treatment delivered later during outpatient treatment. The investigators hypothesize that (1) a 12-week attendance-based contingency management intervention will improve retention and enhance drug abstinence versus standard treatment, (2) initial short-term exposure to attendance-based contingency management (in weeks 1-6 only) will improve substance abuse treatment outcomes compared to standard treatment alone, and (3) contingency management in weeks 7-12 will be particularly useful for those with sporadic attendance or continued drug use during initial stages of treatment.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* current DSM-IV diagnosis of cocaine abuse or dependence or recent cocaine use (self-reported use in past 30 days or positive urine toxicology screen)
* willing to sign informed consent and able to pass an informed consent quiz

Exclusion Criteria:

* serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination
* in recovery from pathological gambling (meet DSM-IV criteria for lifetime pathological gambling and are actively trying to refrain from gambling)
* do not speak English (all treatment is provided in English at these clinics)
Osteoporosis School

The purpose of this study is to investigate the efficacy of systematic education (osteoporosis school) on fall frequency, compliance and quality of life of a group of patients more than fifty years of age.

Hypothetically, systematic information can increase compliance to the medical treatment, decrease the frequency of falls and increase the quality of life.

In most randomized trials compliance to medical treatment in osteoporosis is very high, but compliance tends to be considerably inferior in routine treatment compared to scientific trials. This fact is caused by a narrow selection of motivated patients in the randomized trials. Perhaps, the information given to the patients in scientific trials is more thorough than information given in a routine setting.

There are no trials available that document that compliance to medical treatment of patients with osteoporosis can be increased by intensive systematic information.

Change of lifestyle is an important part in the treatment of these patients. The patients are encouraged to eat more healthy food combined with an intake of calcium and vitamins, reduction of alcohol and tobacco consumption if needed and prevention of fall incidence through changes in the house.

The quality of life is often reduced, partly due to chronic pain, altered social status, physical handicap and partly due to the heavy knowledge of having a chronic decease.

Adaption to the last-mentioned factors can possibly lead to a considerably better quality of life in spite of the unchanged physical handicap.

Randomized trials on efficacy of systematic patient education has in general been positive in other contexts. Young patients with diabetes offered coping skills training have therefore a better metabolic control and quality of life.

No similar randomized trials are available on the efficacy of a systematic education program in osteoporosis.

Eligibility Criteria:
Inclusion criteria:

* fracture caused by osteoporosis
* fifty years or more of age
* informed consent

Exclusion criteria:

- Physically or mental state that does not participation
Premedication for Non-Emergency Endotracheal Intubation In the NICU

Those infants who received the muscle relaxation in combination with the vagolytic (reduce vagus nerve impulses) and pain medication will have reduced time to successful intubation (placement of tube into the lungs), a decrease in the number of attempts, and better intubation conditions reported by the practitioner. The objectives of the study include: 1.) Does the medication protocol outlined in this study provide optimal intubation conditions? (i.e.good jaw relaxation, open and immobile vocal cords and suppression of gag reflex) 2.) Does the addition of a muscle relaxant prior to intubation contribute to less attempts and achieving successful intubation as opposed to neonates who do not receive the muscle relaxant.

The investigators project will study two different strategies of pre-medication in an attempt to eliminate the pain and discomfort associated with the elective intubation procedure. The study will be blinded and patients will be randomized in two different arms according to gestational age and identified by study number for pre-medication protocols. Demographic as well as study information prior, during and post intubation attempt will be recorded and closely monitored. Each patient will be monitored for study purposes for at least 24 hours after intubation attempt to record any potential side effects of the medication. The investigators plan to have a data safety monitoring board established composed of three pediatric doctors / specialists not associated with this study.

The response of paralysis, onset and duration will be assessed clinically. Onset of muscle relaxation will be described as the absence of spontaneous movements and flaccidity, measured in seconds from the end of the medication administration. Duration of paralysis will be determined by the difference in time from the onset of paralysis to the return of spontaneous movements and pre-intubation tone

Eligibility Criteria:
Inclusion criteria:

1. Infants admitted to the NICU at Beaumont Children's Hospital Royal Oak and Troy.
2. Gestational Age 28 0/7 weeks (or post menstrual age 28 0/7 weeks) or higher
3. Infants who require endotracheal intubation on a non-emergent basis
4. Signed informed consent by parents

Exclusion criteria:

1. intubations that occurred in the delivery room or for other emergent basis,
2. absence of intravenous access
3. abnormality of the airway
4. known or family history of neuromuscular disorder
5. renal insufficiency (urine output \<0.6 mL/kg per hour or creatine \>1.7 mg/dL if \> 1 day of age)
6. known hepatic insufficiency (abnormal liver function or coagulation laboratory results)
7. Current diagnosis of pulmonary hypertension
8. Any infant deemed by the attending neonatologist as unstable or unfit for the study