cyrilzakka/clinical-trials huggingface dataset:
Butorphanol in Pain Following Ablation for Hepatic Tumor

The objective of this investigation was to evaluate the influence of Butorphanol on postoperative pain mitigation in patients undergoing microwave ablation for hepatic tumor. Employing a rigorously designed multicentral, randomized, and placebo-controlled format, patients subjected to microwave ablation were assigned randomly to either Butorphanol (experimental group) or normal saline (control group). Primary outcomes encompassed intraoperative pain levels assessed through patient-driven evaluation utilizing a 10-point visual analog scale (VAS). Secondary outcomes included postoperative pain levels at the 6-hour mark (VAS) and comprehensive pain assessment outcomes.


Eligibility Criteria:
Inclusion Criteria:

patients performing Microwave Ablation sign the informed consent

Exclusion Criteria:

Patients with a body mass index \> 30 kg/m2 a history of depression opioid dependence poorly controlled hypertension (systolic blood pressure \> 180 mmHg) myocardial infarction severe liver disease significant abdominal pain before surgery patients with sensory system or language dysfunctions who could not cooperate to complete the scale pregnant women.
Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Effect of systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery

This study is proposed to explore the effect of systemic dexamethasone on the duration of popliteal nerve block for analgesia after pediatric ankle surgery.

After ankle or foot surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anesthesia is particularly important in children due to the much lower toxicity threshold of local anesthetics. The use of an effective adjuvant, such as Dexamethasone, could allow for the use of a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

There is multiple research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a huge lack of research regarding children.

In this study, investigators compare different doses of systemic dexamethasone. Before the anesthesia, the patients receive dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg, and 0.2mg/kg.

The investigator's goal is to find a dexamethasone dose that is as low as possible but at the same time covers the need for good pain relief and fast recovery postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* children scheduled for ankle/foot surgery
* body weight \> 5kg

Exclusion Criteria:

* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use
Clinical Efficacy of a Non-Invasive Measure of Intracranial Pressure

This study is designed to evaluate the accuracy of a non-invasive method phase-contrast magnetic resonance imaging (MR-ICP) for assessing intracranial pressure (Phase 1).

To perform second phase contrast imaging to evaluate the patency and flow of ventricular catheters after MR-ICP imaging (Phase 2).

The study will be divided into 2 phases. In Phase 1, patients with an intracranial pressure monitor will be recruited to the study, while in Phase 2, patients with shunts or Cerebral Spinal Fluid (CSF) access devices (Ommaya, reservoir, etc.) will be eligible for the study.

Two separate groups of patients will be recruited to each phase of the study. Each phase of the study will involve MR-ICPs. The MR-ICP is an extra 5-10 minute sequence at the end of a MRI that assesses the pressure in the head. The MRI will take scans of the brain during different phases of the cardiac cycle and will assess the volume changes while the patient is lying flat. The pressure in the head will be estimated based on these calculations. This estimate will be compared to the pressure in the head as determined by the ICP monitor.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred for a MRI by Attendings in the Department of Neurological Surgery at the University of Miam with intracranial pathology with external ventricular drains (EVDs) or intracranial bolts placed for hydrocephalus or intracranial hypertension. Bolts must be placed prior to enrollment in the study to avoid any alterations in standard procedure
* All pathological entities that produce intracranial hypertension will be included (trauma, tumor, vascular, infectious, inflammatory, etc).
* Patients must undergo a MRI for another clinically indicated reason (diagnosis, surveillance, cervical MRI clearance, prognosis, etc).
* English and Spanish-speaking patients

Exclusion Criteria:

* Unable to obtain MRI due to prior implants, metallic material, inability to sit still
* Refractory intracranial hypertension (not controlled with medications, surgery, or EVD)
* Unable to obtain informed consent
The Effects of Wellness Training Given to Fifth Grade Students During the Covid-19 Epidemic Period

This study conducted an experimental study with a randomized control group to decide on the quality of life and physical activity of the Wellness education for fifth grade students during the Covid-19 pandemic process.

After the population and sample calculations were made, the students who had their pre-tests were randomized to the Wellness Education Group and the Control Group. In this study conducted in two state secondary schools affiliated to Kırşehir Provincial Directorate of National Education, the experimental group was given Wellness training. No intervention was made to the control group. Four weeks after the training, the students were post-tested and the data were analyzed.

In order not to affect the groups from the practices to be made, first of all, schools were randomized and the schools were divided into Wellness Education Group and Control Group with a closed envelope lot method. Prof. Dr. Erol Güngör Secondary School (Group I) Wellness Education Group has been assigned to Kırşehir Merkez Yunus Emre Secondary School (Group II) Control Group. Experimental and control groups in order to reduce selection bias and control variables that may have an effect on outcome variables; A randomized assignment was made by a statistician who did not know the names and characteristics of the students. In determining the students to be included in the study; Student lists and the Excel 2016 program were used, and Simple Random Sampling was performed. The student lists assigned to the groups by the expert were submitted to the researcher before the initiatives started.

Eligibility Criteria:
Inclusion Criteria:

* Being a fifth grade student,
* Not having any physical or mental disability,
* Agree to participate in research,
* Not allowed to participate in research by their parents.

Exclusion Criteria:

-
HEFTME System for Adjuvant Therapeutic Selection of Locally Advanced UTUC Postoperatively：A Perspective Cohort Study

This multicenter, real-world study introduces a novel Hematoxylin-eosin staining(H\&E)-based four tumor microenvironment (TME) system (HEFTME system) assisting in prognostic prediction and precise adjuvant treatment selection for laUTUC postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* pathological diagnose of UTUC;
* Met more than muscle-invasion stages(pT2+) or lymph nodes metastasis.

Exclusion Criteria:

* Patients with early-local stages (pTa/T1/Tis) without LNM+ and those with incomplete pathologic and prognostic information were excluded
Hemoderivative Imputable Complications in Initial Uncomplicated Heart Surgery

Observational Study of Hemoderivative Transfusion Imputable Complications in Initial Uncomplicated Heart Surgery. Inclusion criteria are patients who discontinued the mechanical ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs up to the beginning of the second postoperative day.

Blood transfusion might be only a marker of the patient severity.

Criteria for blood transfusion during extra corporeal circulation (if used) is volume expansion need leading to a predictable hematocrit lower than 25%.

Criteria for blood transfusion after extra corporeal circulation or in the postoperative period is a hematocrit below 30% with signs of low cardiac output due to hypovolemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acquired heart disease with indication for surgery and who discontinued the mechanical ventilation up to 6 hours after exiting operation room and who discontinued vasoactive drugs up to the beginning of the second postoperative day.

Exclusion Criteria:

* Patients who received blood transfusion previous to the heart surgery.
Supplementation After Bariatric Surgery

The aim of this study is to assess medication adherence to vitamin and mineral supplements after bariatric surgery and identify factors that may influence adherence. All study participants are prescribed life-long treatment with daily oral vitamin B12 and Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation. Post-operative adherence rate is retrieved from Pharmacy refill data, collected from the Swedish Prescribed Drug Register, the five first years after bariatric surgery.

The aim of this study is to assess medication adherence to vitamin- and mineral supplementation after bariatric surgery, identify factors that may influence adherence, as well as study the development of micronutrient deficinencies detectable by blood sampling.

All study participants are prescribed life-long treatment with daily oral vitamin B12 and Calcium/Vitamin-D. Menstruating women are also prescribed daily oral iron supplementation.

Post-operative adherence rate is retrieved from pharmacy refill data, collected from The Swedish Prescribed Drug Register, at one, two and five years after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Patients subjected to bariatric surgery at Vrinnevi Hospital, Norrköping, Sweden

Exclusion Criteria:

* Unable to read and understand Swedish
JASPER Intervention in Down Syndrome

The goal of this study is to determine whether JASPER (Joint Attention, Symbolic Play, Engagement, Regulation), which is an intensive, targeted early behavioral intervention focused on a developmentally based approach for teaching joint engagement, joint attention, and play skills can improve behavioral / emotional regulation, social communication skills, and developmental trajectories in Down syndrome (DS). The investigators will also explore the potential use of EEG and event-related potentials (ERP) as outcome measures, as this approach may help elucidate mechanisms of change in behavior and development, and may help explain differences in development of social communication skills in individuals with DS. EEG and ERP measure may also help to predict treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Trisomy 21
* Age 24-48 months
* Able to walk independently across a room
* Uses at least 5 words / signs
* English speaking
* Parent able to accompany participant to all study visits

Exclusion Criteria:

-Diagnosis of Mosaic / Translocation Down syndrome
A Randomized Trial Comparing a Ventilatory Strategy to Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA Vs. LADS Trial)

To learn if LADS is better than VESPA at preventing atelectasis during a robotic bronchoscopy.

Primary Objective:

To compare the proportion of patients developing target-obscuring atelectasis when using a lateral decubitus strategy (LADS) vs using a ventilatory strategy to prevent atelectasis (VESPA) during robotic bronchoscopy for posteriorly-located peripheral lung lesions.

Secondary Objectives:

* To compare the proportion of patients with atelectasis in the target lobe in VESPA vs. LADS during robotic bronchoscopy.
* To compare the proportion of patients with atelectasis obscuring 100%, 50% or more, and less than 50% of the target during robotic bronchoscopy using LADS vs. VESPA.
* To compare the proportion of patients in whom a biopsy sample was not taken due to atelectasis using LADS vs. VESPA.
* To compare the diagnostic yield using LADS vs. VESPA.
* To compare the proportion of tool in lesion (TIL) using LADS vs. VESPA.
* To compare the diagnostic accuracy (sensitivity and specificity) for malignancy using LADS vs. VESPA.
* To compare the proportion of LADS-induced vs. VESPA-induced complications.
* To compare the proportion of bronchoscopy-induced complications in LADS vs. VESPA.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥ 18 years old) undergoing diagnostic robotic bronchoscopy for a lung nodule suspicious for malignancy bronchoscopy under general anesthesia.
2. Lung nodules should be up to 3 cm in diameter and located in right or left bronchial segments B2, B6, B9, and B10. Greater than 50% of the volume of the lesion needs to be below a horizontal line traced at the most anterior edge of the corresponding vertebral body.
3. Chest CT performed \< 4 weeks prior to bronchoscopy.
4. Voluntary informed consent to participate in the study.

Exclusion Criteria:

1. Patients with prior lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) as seen on most recent CT
2. Lesions outside of the designated lung areas defined as inclusion criteria.
3. Known pregnancy
4. Vulnerable population
5. Ascites
6. Known diaphragmatic paralysis
7. Smokers or ex-smokers with known or suspected severe air-trapping defined as residual volume \> 150% of predicted
8. History of primary or secondary spontaneous pneumothorax
9. Lung bullae \> 5 cm
10. Patients with mediastinal or hilar adenopathy with high suspicion for malignancy in whom lymph node sampling is indicated and should occur prior to robotic bronchoscopy of the peripheral lesion.
11. Patient with active COVID pneumonia.
Evaluation of Treatments for Allergic Rhinitis (Rhinal 2)

The goal of this clinical study is to perform a post-market clinical follow-up of 2 medical devices (liquid bandage in the form of a spray : ALLERSPRAY G (product A - code AAG), PCNS (product B - code PC) indicated for symptomatic treatment of allergic rhinitis. This follow-up will consist in collecting real-life clinical data to confirm the safety and efficacy of medical devices used in the treatment of allergic rhinitis of adults patients while allowing an assessment of the product's risk/benefit ratio.

The main questions it aims to answer are:

* Primary objective : Evaluate in real life the tolerance of medical device A and B used in the treatment of allergic rhinitis.
* Secondary objectives : Evaluate the efficacy of medical device A and B on allergic rhinitis and the quality of life using the device A and B.

No comparison group will be constituated because of the type of study (post market follow up) and no comparison between device A and B will be done.

58 participants (29 for medical device A and 29 for medical device B) with allergic rhinitis will be asked to :

* use medical device A or B during 2 weeks (from inclusion visit to end of study visit),
* complete each day at home a diary (recording intensity of 4 nasal symptoms, adverse events, concomitant treatments),
* complete " Quality of life evaluation (sleep, daily activities, fatigue, irritability) " at inclusion visit and end of study visit.


Eligibility Criteria:
Inclusion Criteria:

* " Score For Allergic Rhinitis " ≥ 8
* Age ≥ 18
* Able to refrain from using any treatment for allergic rhinitis or any other treatment that could interfere with the purpose of the study,
* Effective contraception for women of reproductive age,
* Cooperation and understanding sufficient to comply with the requirements of the study,
* Acceptance to give written consent and inscription to VRB french platform for the duration of the study,
* Affiliation to the French Social Security system,

Exclusion Criteria:

* Known hypersensitivity to any of the components of the evaluated products,
* Use of any treatment to treat allergic rhinitis,
* pregnant or breastfeeding women,
* participating in another clinical trial, or being in the exclusion period, or having received a total amount of benefits exceeding EUR 6000 over the 12 months preceding the start of the trial,
* benefiting from a measure of legal protection (guardianship, deprivation of liberty, safeguard of justice),
* having a medical and / or surgical history judged by the investigator or his representative to be incompatible with the test
Visual Perceptual Motor Training on Kindergarteners

The study aims to investigate the effects of different visuomotor training programs on children's visuomotor skills and handwriting performance.

The purpose of this project is to investigate the effectiveness of visuomotor activities with different activity materials on fine motor, visual perception, visual-motor integration and handwriting performance of kindergarten children. Kindergarteners will be randomized into the three groups: control, Chinese, and traditional groups. Children in the Chinese and traditional groups will receive a visual perceptual motor training program twice every week for 12 weeks and those in the control group will not receive any intervention during the study period. in the end of fall semester of the first grade, the effectiveness of the interventional programs on handwriting performance of participants will be examined again.

Eligibility Criteria:
Inclusion Criteria:

* Kindergarten children who will study the first grade in coming September
* Both parents are native Mandarin Chinese speakers

Exclusion Criteria:

* A diagnosis of significant neurological, muscular, and skeletal system disorders
* Visual or hearing problems that cannot be corrected to be normal
* Genetic or chromosomal abnormality
* Significant neurological, muscular, and skeletal damage to the trunk or upper extremities
* moderate or severe intellectual disabilities
Couplelinks.ca - An Online Intervention for Couples Affected by Breast Cancer

Women diagnosed with breast cancer (BC) at or before the age of 50 experience more distress and poorer quality of life than women diagnosed later in life. Although adequate spousal support is a protective factor for women with BC, spouses are often unprepared to handle the myriad practical and emotional demands posed by the illness. Furthermore, despite the growing number of recommendations for couple interventions in relation to BC, traditional counselling approaches may fail to meet the needs of young couples who have unique concerns and tight constraints on their time. The proposed project addresses the void in the psycho-social support available to young couples via an innovative, online psychoeducational intervention tailored specifically to their needs.

Couplelinks.ca is a custom-designed website offering a professionally facilitated, couple-centred intervention that entails informational, experiential, and interactive components. Six Dyadic Learning Modules (DLM) form the core of the program and are undertaken on a weekly basis.

A funded pilot study examining the feasibility and benefit of Couplelinks.ca utilized a non-randomized, pre-post test design to assess the process and outcomes of the intervention. Qualitative feedback also informed the evaluation. Preliminary findings were promising and provided justification for further evaluation of the program's effectiveness.

The current study is the next logical step: a larger-scale Phase III study to determine whether this BC-specific, relationship-enhancement program leads to improved relationship and psychological outcomes for young couples affected by BC. It is a randomized controlled trial (RCT) comparing level of distress and dyadic adjustment in couples who have participated in the Couplelinks.ca educational program to those who have not participated and were instead put on a wait-list for participation.

Eligibility Criteria:
Inclusion Criteria:

* couples where woman has received a diagnosis of nonmetastatic breast carcinoma;
* diagnosis was within the last 36 months;
* woman is age less than or equal to 50 at age of diagnosis;
* completed or are nearing the end of active treatment;
* couples must be in a committed, heterosexual relationship;
* fluent in English with the ability to read and write in English.

Exclusion Criteria:

* non-heterosexual couples;
* women older than 50;
* previous diagnosis of moderate to severe psychological problems that may interfere with capacity to benefit from the intervention;
* couples who plan to participate in couple counselling during the 5-month study duration.
Interindividual Variation in Response to Green Coffee

The study is a multifaceted approach to investigate the effects of regular consumption of green coffee rich in polyphenols (hydroxycinnamic acids) on weight, body composition, cardiometabolic and inflammatory biomarkers in a sample population of overweight and obese people aimed at identifying a population of responders to green coffee experimenting the highest benefit from this product, and to contribute to the understanding of the influence of some of the main factors on the response to green coffee and their association with the differences between individuals (high-responders vs. low-responders).

A randomized, cross-over, blind clinical trial will be carried out to evaluate the health effects of a polyphenol-rich green (slightly roasted) coffee in comparison with traditional roasted coffee to identify high- and low-responders.

Participants will consume the green and roasted coffee in a randomized order during 12 weeks, separated by a 4-week wash-out (and a previous 2-week run-in). Fasting blood samples will be collected in each of the 6 visits to the research centre. Blood pressure and body composition and anthropometric variables will be measured. In addition, urine and fecal samples will be obtained at the beginning and end of each intervention stage to analyze the bioavailability and metabolism of phenolic compounds, and the intestinal microbiota, respectively. Physical activity and energy expenditure will be measured in each of the interventions.

Besides a thorough cardiometabolic and inflammatory characterization of the volunteers, the frequency of specific genotypes (related with obesity, energy metabolism, inflammation and coffee intake) will be analyzed, as well as lifestyle and dietary habits of the participants, including aspects such as chrono-nutrition, sleep quality and wellbeing perception with the aim to contribute to clarify the determinants of inter-individual variability in the health effects of coffee bioactive phenolic compounds.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index 25-35 kg/m2

Exclusion Criteria:

* Smoking
* Vegetarian/Vegan
* Pregnant/lactating women
* On prescription drugs other than for thyroid/hypertension/dyslipemia, or changes in dosage in the last 3 months.
* Consumption of vitamins or dietary supplements
* On weight-reduction dietary regime or physical training to reduce body weight
* Having taken antibiotics 3 months before starting the intervention
* Intestinal, hepatic or renal diseases, coffee intolerance