cyrilzakka/clinical-trials huggingface dataset:
Caudal Bupivacaine vs Bupivacaine Plus Two Doses of Dexmedetomidine for Postoperative Analgesia in Children

The aim of this prospective randomized double-blind study was to compare the analgesic efficacy and the side effects of two doses of dexmedetomidine (1 and 2 µg.kg-1) co-administered with bupivacaine with bupivacaine alone for caudal analgesia in children undergoing infra-umbilical surgery.

* Quality assurance plan for data validation and registry: After Data was registered, it was reviewed by a second person who compared it to the Data in patient data collection forms.
* Data check: carried out using Statistical Package for the Social Sciences (SPSS) variable definition protocols. Also data were entered in EXCEL sheets for comparisons to guarantee consistency.
* Source data verification: Paper case report forms and medical records.
* Standard Operating Procedures to address registry operations and analysis activities: Eligible patients were recruited after obtaining consent. Data was collected by qualified personnel rained on the process. Data was entered into Excel sheets and SPSS programs and compared for consistency. Analysis of Data was carried out by a qualified statistician. Adverse events were reported as yes/no variables. Data of patients who had Change in management was omitted from analysis.
* Sample size assessment: Sample size was calculated to detect a 65% reduction in the analgesic requirement during the first 24 h from 75% in the bupivacaine group with α= 0.05 and β=0.80.
* Plan for missing data: Patients with missing Data were omitted from statistical analysis.
* Statistical analysis plan: carried out using International Business Machines (IBM) statistics 19.0 statistical package for windows. Data were compared using analysis of variance for continuous variables, Kruskal-Wallis test for ordinal, and chi square test for categorical ones. Post hoc analyses were carried out as appropriate.

Eligibility Criteria:
Inclusion criteria:

* Patients with American Society of Anesthesiologists (ASA) - I
* Scheduled for lower abdominal and perineal surgery
* Under general anesthesia

Exclusion criteria:

* history of developmental delay or mental retardation
* known or suspected coagulopathy or recent use of anticoagulant/antiplatelet drugs.
* known allergy to any of the study drugs.
* any signs of infection or congenital abnormalities at the site of the proposed caudal block
Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial

This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy
* Postmenopausal
* Hysterectomized or non-hysterectomized
* Moderate or severe vaginal dryness and soreness
* Successful completion of the study VAG/PD/009/USA

Exclusion Criteria:

* Known, suspected, or past history of breast cancer
* Known, suspected, or past history of hormone-dependent tumor
* Genital bleeding of unknown etiology
* Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use
* Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA
* Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days
Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department

Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of back pain. A total of 150 patients age 18-65 presenting to the emergency department with chief complaint of backpain will be enrolled from April 2024 - April 2025. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 65 years old
* Presenting to the Bronson ED with a chief complaint of acute, non-traumatic back pain
* VAS score \>5 cm

Exclusion Criteria:

* Back pain due to traumatic injury
* Experiencing saddle anesthesia
* Has bowel or bladder dysfunction
* Has an abnormal neurological exam
* Requires imaging in ED
* Has a Glascow coma score \<15
* Has one or more abnormal vital signs:

HR\>120, SBP\>180 or \<90, temperature \>38°, O2 saturation\<92%

* Has an allergy to ketorolac or haloperidol
* Has a known diagnosis of Lewy Body Dementia
* Has a known diagnosis of glaucoma.
* Is known to be pregnant or breastfeeding
* Is a prisoner or ward of the state
* Is unable to consent for themselves/ non-english speaking
* In the opinion of the attending physician or investigator the patient should not participate in the research
Investigating Interventions to Reduce Residual Opioids in the Home Following Legitimate Opioid Prescribing in Children.

The overall objective of this study is to evaluate strategies to reduce unused opioids prescribed for pediatric acute post-surgical pain management.

Prescription opioids are abused by an estimated 12.5 million Americans, and accidental opioid overdose is the leading cause of injury death in the US. Many of these drugs originate from leftover prescription opioids related to postoperative overprescribing, lack of proper disposal, and unsafe home storage. Governmental guidelines indicate that leftover prescription opioids should be preferentially returned to a drug take back site; however, many people do not utilize these programs due to travel distance, lack of transportation, or other factors.

The aims are to quantify the amount of unused opioids in the home following painful pediatric surgical procedures, investigate the impact of formal interventions on disposal of residual opioids in the home following these surgeries, and to identify current behaviors of adolescents and their family members in the handling of unused prescribed opioids.

Eligibility Criteria:
Inclusion Criteria:

* Male or female children ages 12-17.9 years old
* ASA physical status 1 and 2
* Patients undergoing primary posterior spinal fusion surgery for correction of idiopathic scoliosis.
* Patients undergoing Nuss bar correction of pectus excavatum deformity.

Exclusion Criteria:

* Oxycodone allergy
* severe sleep apnea
* developmental delay
* neurological disorders
* liver disease/impairment
* renal disease/decreased renal function
* patients on opioid therapy prior to surgery
* Requires a translator for communication in English
The Association Between Periodontal Disease and Malnutrition in a Group of Elderly People in Thailand.

This study will be determine the association between periodontitis and malnutrition status in older adult.

Ageing may accompany with an accumulation of diseases and impairments cause by physiological, socioeconomic and psychological changes. The older adults are more prone to nutritional deficiencies due to combination of factors such as ageing, excessive polypharmacy, general health decline, poor socioeconomic status, cognitive decline, poor appetite, impaired efficacy of swallowing and limit eating ability.

Periodontitis is a multifactorial disease predominantly a bacterial infection involving the dental biofilm or dental plaque. Periodontitis increases in extent and severity across a large proportion of the human population with ageing. The effects of ageing on the immune system include distinct alterations in both innate and adaptive immune-cell function and effector biomolecules, resulting in processes reflecting immunosenescence, immunoactivation and inflammaging. Moreover, genetic contribution alters immunity and inflammation that play a role in the dysregulation of host responses in ageing. The combination of chronic antigenic burden and uncontrolled inflammatory response can enhance immunosenescence and ageing-associated disease. Periodontitis also has an effect on food intake, nutritional status and quality of life in older adults.

However the relationship between chronic periodontitis and malnutrition in older adult is not clear and needs further study. In this study will be determine the association between periodontitis and malnutrition status in older adult.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who has aged ≥ 60 years old.
2. Subjects who not receive periodontal treatment within the previous 6 months.
3. Subjects who are able to read Thai and express verbal communication.
4. Subjects who are functional independent older adults (get ≥ 12 points from Barthel Index for Activities of Daily Living) \[50, 51\].
5. Subjects who are cognitive functional independent older adults (get \> 23 points from Thai Mental State Examination) \[52\].

Exclusion Criteria:

1. Subjects with completely edentulous area.
2. Subjects who require antibiotic prophylaxis for dental examination
Diagnostic Agreement of iFR and QFR.

A Prospective, observational, single center diagnostic study to investigate the the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting.

During coronary angiography, intermediate stenoses can not be adequately assessed by visual assessment alone. It is necessary to evaluate the functional significance to guide their treatment.

Fractional Flow Reserve (FFR) is the current gold standard for determining this functional significance but its adoption in clinical practice remains low. The instantaneous wave-free ratio (iFR) is an alternative way to determine the flow-limiting characteristics of a coronary stenosis with a pressure wire but without the need to induce hyperemia. Large randomised trials have confirmed the non-inferiority of iFR in respect to FFR in terms of outcome.

Quantitative Flow Ratio (QFR) is another new method for evaluating the functional significance of coronary stenosis It is a software-based analysis of conventional angiographic images to estimate the pressure drop caused by a coronary stenosis. The diagnostic agreement with FFR seemed promising in the FAVOR Pilot Study and a larger trial is enrolling for confirmation.

A stepwise approach of QFR and iFR could make the functional assessment of intermediate stenoses more practical and cost-effective. However before being used as a combination in daily practice, QFR has to be validated in respect to iFR.

The primary objective of the trial is to investigate the diagnostic agreement between QFR and the pressure wire-based iFR in a real world setting

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 with symptoms of myocardial ischemia and angina or angina equivalent (chest pain, abnormal stress testing, abnormal noninvasive testing)
* Patients witch semi recent (\>3 days) acute coronary syndromes can be included but only for the non-culprit vessels and outside of primary intervention during acute myocardial infarction.
* Willing to participate and able to understand, read and sign the informed consent document before the planned procedure
* Eligible for coronary angiography and/or percutaneous coronary intervention
* Coronary artery disease with at least 1 or more visually assessed de novo coronary stenosis (30-90% diameter stenosis) in native major epicardial vessel or its branches by coronary angiogram.

Exclusion criteria:

* Contraindication to adenosine administration
* Previous Coronary Artery Bypass surgery with patent grafts to the interrogated vessel
A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants

The main purpose of this study is to assess the effect of carbamazepine on the amount of orforglipron in the bloodstream and how long it takes the body to get rid of orforglipron when given orally in healthy study participants. The safety and tolerability of orforglipron and carbamazepine when given separately or together will also be evaluated. The study may last up to approximately 77 days for each participant.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be overtly healthy individuals, assigned male at birth (AMAB) or individuals not of childbearing potential (INOCBP).
* Have a body weight equal to or greater than 45 kg, and body mass index (BMI) between 18.5 and 35.0 kilograms per meter squared (kg/m²), inclusive, at screening.
* Have a hemoglobin level of

  * at least 11.4 g/dL for individuals assigned female at birth (AFAB) and
  * at least 12.5 g/dL for AMAB.
* Have venous access sufficient to allow for blood sampling.

Exclusion Criteria:

* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking orforglipron; or of interfering with the interpretation of data.
* Have an abnormal 12-lead electrocardiogram (ECG).
* Have human leucocyte antigen-B (HLA-B)\*1502 or HLA-A\*3101 allele; participants with other alleles that demonstrate strong evidence of association with carbamazepine-induced hypersensitivity reaction or hepatic impairment may also be excluded.
* Have a history or presence of multiple or severe allergies, or severe post treatment hypersensitivity reactions.
* Have known allergies to carbamazepine or to orforglipron, related compounds, or any components of the formulation.
Lumbar Spine on MRI and Low Back Pain in Elite Cross-country Skiers

The investigators will examine the prevalence of low-back pain and disc degeneration among Finnish elite skiers between 16 and 35 years of age and compare these findings with the data collected among healthy volunteers studied between 1994-2021.

The study population will consist of Finnish elite cross-country skiers between 18 and 35 years of age. Invitation letters will be sent to all skiers who are selected to national teams at season 2022-2023. The study population for the current study will be approximately 100 individuals. Study protocol for the current study will consist of a semi-structured interview, clinical examination, lumbar spine MRI and patient reported outcome measures. All participants will sign an informed consent before commencement of the study. If a participant is younger than 18 years, also his/her caregiver will be asked for a signed consent.

The interview comprised of questions about the athletes training volume and possible LBP without associated trauma. (suspension from training or competition due to LBP, possible contacts to health-care providers).

Body height and weight were self-reported. Leg length inequality was assessed comparing the height of the left and right iliac crests in standing position with straight knees. Wooden blocks of different thickness (with 0.5 cm increment) were used for correction of possible leg length inequality. Symmetry of the back was measured in forward bending using a scoliometer.

From MRI (high field 1.5 T) the signal intensity of the nucleus pulposus will be assessed both qualitatively and quantitatively. The midline T2-weighted images will be independently evaluated visually by three evaluators using a Pfirrmann classification. The quantitative nucleus signal intensities will be assessed by two evaluators using a relative measure comparing the signal intensity of the nucleus pulposus to that of the adjacent cerebrospinal fluid on T2-weighted images.

Eligibility Criteria:
Inclusion Criteria:

* Finnish elite cross-country skiers (national teams from the age of 16)

Exclusion Criteria:

* none
Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study

Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense emotional or physical stress. Recovery of this condition varies and many patients continue to suffer from symptoms such as fatigue and breathlessness for a protracted period after their event. Research conducted in our unit has found that the heart function does not recover fully as is commonly believed and that the energetic status of the heart remains impaired for an extended period of time. The purpose of our study is to establish whether following a structured exercise program or a mental wellbeing program compared to usual care for 12 weeks after an episode of Takotsubo will improve the energy status of the heart, their physical conditioning and improve the general mental wellbeing of patients.

Acute takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. The researchers have shown that recovery is more protracted than previously appreciated, and is associated with persistent major morbidity and a long-term heart failure phenotype. In the absence of any effective therapeutic options, the researchers propose a mechanistic three-arm pilot feasibility trial of early rehabilitation (standardised physical exercise training or cognitive behavioural therapy) versus current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy. The primary end-point will be the restoration of cardiac energetic status assessed by 31P-magnetic resonance spectroscopy and the secondary end-points of cortisol awakening response, global longitudinal strain by echocardiography and the 6-minute walk test. If successful, this has the potential for rapid implementation into a large randomised clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* A patient who has recently suffered an episode of takotsubo cardiomyopathy within the last three weeks
* Participant who is willing and able to give informed consent for participation in the study.

Exclusion Criteria:

* Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them for taking part in a physical exercise training program.
* Any patient who is not able or not willing to travel to the cardiovascular research facility for their study visits.
* Any patient who is not able to commit to a 12 week supervised training program.
* Inability to exercise on a cycle ergometer (i.e. use of walking aids or prosthetic limbs).
* Contraindication to magnetic resonance scanning such as an implantable cardiac device.
* Pregnancy
Cytokines, POD, Health Status, Older Hip Fracture

An investigation of the change in inflammation marker levels across hip fracture surgery and an exploration of any association with change in self reported health status and incidence of postoperative delirium


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years old
* Admitted for primary hip fracture surgery

Exclusion Criteria:

* Preoperative cognitive impairment
* History of neurosurgery, neurologic diseases or head trauma
* Current systemic bacterial or viral infection
* Complex or multiple injuries
SAFE Nerve Sparing Guided by Micro-ultrasound (MUS)

Robotic-assisted radical prostatectomy (RALP) has become the standard of care in the management of localized prostate cancer. However, post-prostatectomy erectile dysfunction (ED) and urinary incontinence still pose a challenge that adversely affects the patient's quality of life. Hydrodissection (HD) was introduced in 1987 in the medical field and it was tested for the first time during a retropubic radical prostatectomy back in 2005. Since then, research has indicated an improvement in erectile function results, presumably because of a less traumatic neural dissection and a decreased risk of neuropraxia. In an effort to achieve a balance between oncological excision and functional preservation, prostate surgery is evolving to incorporate intraoperative real-time evaluation of extracapsular extension. Recently, a micro-ultrasound operating at 29 MHz has been introduced. It provides a resolution down to 70 μ to assess the glandular pattern and cellular density of the prostatic tissue. Given the experience in more than a thousand cases with this technology, and the growing literature showing promising results in the detection and staging of prostate cancer; the researchers decided to implement this tool as guidance for hydrodissection of the layers of the lateral prostatic fascia.

Robotic-Assisted Laparoscopic Prostatectomy and SAFE (Saline assisted fascial engorgement) nerve preservation guided by Microultrasound (MUS) is a prospective randomized controlled trial designed to evaluate the impact of normal saline solution hydrodissection (HD) on erectile function outcomes after RALP. This innovative approach consists of a transrectal ultrasound-guided HD using a high-resolution Microultrasound (MUS) (ExactVu micro-ultrasound, Exact Imaging, Markham, Canada). The technique will be applied to those patients who undergo grade 1, 2, or 3 NS approach taking into account the grading system proposed by Tewari et al.

The hypothesis is that the SAFE technique could minimize the risk of a traumatic neurovascular bundle dissection while assessing the prostatic capsule integrity with a high-resolution MUS. The researchers also hypothesize that the use of SAFE along with RALP will optimize the post-surgery recovery of erectile function.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years at the time of consent.
* Men who are potent (SHIM ≥ 17) and sexually active, who are planned to undergo a grade 1, 2, or 3 nerve-sparing approaches, as per the grading system during RALP.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Subjects who are candidates for salvage RALP
* Subjects on androgen deprivation therapy (ADT)
* Subjects in whom PDE5 inhibitors are contraindicated
A Research Study Looking at How 50 mg Semaglutide Daily Affects Food Intake and Emptying of the Stomach in People With Obesity

This study tests if semaglutide tablets of 50 mg can help people with obesity to lower their food intake compared to placebo. This study also tests how semaglutide 50 mg works on appetite, control of eating (such as cravings and restraints) and how long time the food stays in the stomach after a meal.

In addition, how much semaglutide is in the blood will also be tested. Participants will either get semaglutide or placebo - which treatment participants will get is decided by chance. Participants will receive one semaglutide (or placebo) tablet per day during the 20-week treatment period. The dose of semaglutide is slowly increased every 4 weeks during the study to reach the treatment dose of 50 mg semaglutide taken for 4 weeks.

The study lasts for up to 29 weeks for each person and includes a screening period (up to 4 weeks), a treatment period (20 weeks) and a follow-up period (total of 5 weeks after the last dosing). Participants will have 12 visits with the study doctors at the institute.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
* Body mass index between 30.0 and 45.0 kilogram per meter square (kg/m\^2) (both inclusive)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
* Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions