cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Buprenorphine/Naloxone

Long-term use of opioids for chronic pain is a growing health and social problem, mainly because of the risk of dependence. Buprenorphine/naloxone is used as substitution therapy for opioid dependence. This substitution therapy in patients with opioid dependence lessens withdrawal symptoms and craving. There is limited research on the effectiveness of buprenorphine/naloxone in patients with chronic pain and iatrogenic opioid dependence. The primary aim of this study is to investigate the effectiveness of buprenorphine/naloxone in patients suffering from chronic pain and an iatrogenic induced dependence on opioids. This study will investigate the effects of opioid substitution by buprenorphine/naloxone in patients suffering from chronic pain using long-term opioids, with pain and withdrawal symptoms as primary outcome measures. Secondary outcome measures will be craving, substance use, psychiatric comorbidity and quality of life.

This is a prospective open-label observational cohort study (exploratory pilot). Investigators will include 20 patients between 18 and 65 years with chronic pain and dependence on opioids, who were referred by their physician for replacement of opioids to buprenorphine/naloxone. Exclusion criteria are contraindications for buprenorphine/naloxone and patients with psychiatric disorders requiring acute treatment. The degree of pain and withdrawal symptoms will be assessed by the Quantitative Sensory Testing (QST) measurement and the following questionnaires: Visual Analog Scale (VAS), Objective Withdrawal Scale (OWS) and Subjective Withdrawal Scale (SWS). Secondary, craving and substance use/degree of opioid dependence will be studied using the Current Opioid Misuse Measure (COMM) and Obsessive Compulsive Drug using Scale (OCDS). Psychiatric comorbidity will be assessed using the following questionnaires: Depression, Anxiety and Stress Scale (DASS), Personality Inventory for DSM-5 (PID 5-BF), The 20-item Toronto Alexithymia Scale (TAS-20), Inventory of Depressive Symptomatology (IDS), the Perseverative Thinking Questionnaire (PTQ) and Mini International Neuropsychiatric Interview (MINI). These questionnaires are part of the standard assessment at the department of psychiatry at the Radboud University Medical Centre, Nijmegen. The EuroQol five dimensions questionnaire (EQ5D) will be used to assess the quality of life. During the replacement of opioids to buprenorphine/naloxone, the buprenorphine/naloxone protocol will be used.

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women aged 18 to 65 years
* suffering from chronic pain (pain for more than 6 months)
* iatrogenic opioid dependence (according to the DSM-5 criteria)
* there is informed consent for using the data for scientific analyses.

Exclusion Criteria:

* Contraindications for buprenorphine/naloxone, such as severe respiratory insufficiency, severe hepatic insufficiency, alcohol intoxication or delirium tremens.
* In addition participants with psychiatric disorders requiring acute treatment will be excluded, for instance an acute psychosis, acute manic episode or patients who are suicidal.
Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.

The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Non-emergent elective cardiac surgery requiring median sternotomy for surgical exposure (i.e. CABG, aortic/mitral/tricuspid valve replacements) receiving ESP catheter preoperatively
* Age 18-90

Exclusion Criteria:

* Placement and/or existence of cardiac assist devices (LVAD, RVAD, Balloon Pump, Impella)
* Neurocognitive dysfunction
* Patients who expire before extubation
* Non-English speaking
* Daily opioid therapy prior to surgery
* History of substance abuse
* BMI \> 45
ACL Reconstruction With Simple and Double Bundle Technique Using Two Different Implants for Graft Fixation

In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.

In this study our objective is to compare two tibial ACL graft fixation systems in patients undergoing two different reconstructions technique (with simple and double bundle) in terms of tendon graft osteointegration, functionality and return to sports.

This is a single-center prospective randomized clinical trial with 112 patients diagnosed with anterior cruciate ligament rupture randomly allocated in four groups: single bundle with autologous bioabsorbable implant; single bundle with intrafix implant; double bundle with autologous bioabsorbable implant; double bundle with intrafix implant.

Primary outcome is graft ligamentization assessed in MRI images at 4-6 months

Eligibility Criteria:
Inclusion Criteria:

isolated ACL injury for more than six weeks by physical examination and confirmed by magnetic resonance, adult non-elderly (18 to 60 years), nonobese (body mass index within the normal range)

Exclusion Criteria:

intraoperative complications requiring change in technique of reconstruction and / or anesthesia during surgery, patients undergoing cartilage piercing procedures ( such as microfractures) and / or meniscus suture, those with allergies to medications administered during anesthesia, surgery and / or post-operative patients with tourniquet time of more than two hours and patients who did not sign the consent form
Expert@Work - Effectiveness of a Digital Expert Team on Return to Work

Long-term sick leave is a challenge in Norway, and the healthcare and labor- and welfare services are often not coordinated in helping the sick-listed employees return to work. In this study, the investigators want to evaluate the effectiveness of an intervention where an expert team provides advice for an individualized patient pathway based on information from a digital questionnaire and a video meeting with the sick-listed employee and the participant's general practitioner. The patient pathway should include both healthcare and labor- and welfare services measures.

Sick-listed patients with musculoskeletal- and/or common mental disorders are invited to join the study. They will receive a digital questionnaire and be randomized to either treatment as usual or personalized advice from an expert team. The team will be put together based on the response from the individual's questionnaire.

The investigators will evaluate the effect on return to work and the use of health care services 12 months after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Sick-listed minimum 50% between 11 and 20 weeks
* Musculoskeletal disorder and/or common mental disorder
* Living in the county of Trøndelag or Møre- og Romsdal

Exclusion Criteria:

* Specific conditions such as fracture, trauma, infections, malignancy, dislocations, etc.
* Serious mental conditions or another serious disease that makes participation difficult
* Most likely to return to work within 2 weeks
* Not speaking/reading Norwegian
Dementia Antipsychotics And Antidepressants Discontinuation Study

The aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on Behavioural- and Psychological Symptoms in Dementia (BPSD).

Patients with dementia have cognitive deficits, but also hallucinations, delusions, agitation, aggression and apathy. These symptoms are called Behavioural- and Psychological Symptoms in Dementia (BPSD), and are difficult to treat. Antipsychotic and antidepressant medication is used as treatment, despite its lack of clinical evidence.

We will discontinue risperidone in one group of 30 patients and compere them to 30 controls and we will discontinue antidepressants in a group of 76 patients and compere them to 76 controls. Patients should have dementia of Alzheimer- or vascular origin. They should live in Nursing Homes and have no other psychiatric disease for which they receive psychotropic drug. They will be registered with 7 different questionnaires at baseline and after 3, 6, 12 and 24 weeks. The study period is 24 weeks. The questionnaires are filled in by the patients and the nurses at the nursing homes.

This is a double blind RCT study with placebo-controlled group.

Eligibility Criteria:
Inclusion Criteria:

* Vascular- or Alzheimer Dementia
* Nursing Homes resident for 3 months or more
* Given antipsychotics or antidepressants for 3 months or more
* Clinical Dementia rating 1, 2 or 3

Exclusion Criteria:

* Dementia of other origin
* Psychiatric disease
* Life expectancy less than 3 months
* Acute infection last 10 days
* Unstable Diabetes Mellitus
* Terminal disease
Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI

The precise and noninvasive evaluation of disease activity among patients with Crohn's disease is not easy, especially for children. It deals with clinical, biological, histological and radiological parameters.

Bowel sounds (BS) when evaluated by a stethoscope are modified by several factors including surgery, infection, drugs or intestinal inflammation. These factors can interact on intestinal motricity. There is a direct relationship between gastrointestinal motility and characteristics of BW. The study of BS using a stethoscope is a simple method, although operator dependent and subjective,with a wide inter and intraindividual variability. Some studies among adults showed interest in the spectral analysis of BS to assess gastrointestinal motility. This more precise and reproducible method is not operator dependent.

To date, no such study has evaluated the correlation between disease activity and the spectral pattern of BS.

of this project is to assess the correlation between disease activity and the spectral pattern of BS in pediatric Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Crohn's Disease
* Age between 4 and 17 years
* Follow-up at CHU Amiens-Picardie

Exclusion Criteria:

* Other diseases than Crohn's or treatments affecting the gastrointestinal tract, recent (\< 3 months) surgery or refusal to participate (parents or children)
Effect of Mannitol on Recovery Pattern After Orthognathic Surgery

The aim of this study is to test, whether mannitol infusion in different doses will affect recovery pattern? the investigators hypothesized that infusion of mannitol in doses of 0.5 gm/kg before recovery from anesthesia after orthognathic surgery shortens patients' recovery time, and improves recovery quality, as well as postoperative cognitive function better.

The aim of this study is to test, whether mannitol infusion in different doses will affect recovery pattern? the investigators hypothesized that infusion of mannitol in doses of 0.5 gm/kg before recovery from anesthesia after orthognathic surgery shortens patients' recovery time, and improves recovery quality, as well as postoperative cognitive function better Methodology This prospective randomized double blinded study will be applied on patients scheduled for orthognathic surgeries as Temporo-mandibular joint procedures, Le Forte Ι 0r II osteotomy, bimax or maxillectomy after ethical committee approval.

The selected patients were randomly allocated into two groups each containing 30 patients:

* Group M: in which mannitol will be given in doses of 0.5 gm/kg 30 minutes before the end of the surgery
* Group C: similar volume of the infused mannitol but of lactated Ringer will be given 30 minutes before the end of the surgery

Anaesthetic technique:

For all Patients, atropine sulphate 0.015 mg/kg intramuscular (IM) as anti-sialgogue together with dexamethasone 8 mg. Hydrocortisone 100 mg and ranitidine 50 mg, will be given IV as pre-medications 15-30 minutes before induction of anaesthesia patient will be transferred to the operating theatre where ASA-basic monitors will be applied to the patient (pulse-oxymitery, non-invasive blood pressure, ECG 3-Leads and capnography).

Induction of anesthesia:

Regular IV induction will be applied for patients with normal mouth opening where difficult intubation is not suspected: fentanyl 2 μg/kg IV, propofol 1 mg/kg IV, atracurium 0.5 mg/kg IV then nasotracheal intubation with armored tube of appropriate size.

Patients with difficult mouth opening will undergo awake fiberoptic intubation. Anesthesia will be maintained by 100% O2 + 1-1.5 MAC isoflurane Thirty minutes before the end of surgery patients will receive an IV solution which is either mannitol 0.5 gm/kg or lactated Ringer.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years
* ASA status I and II patient.
* No contraindication to use of mannitol.

Exclusion Criteria:

* ASA III and IV status
* Extreme of age: paediatric and geriatric patients
* Severe cardio respiratory, rheumatological or endocrinal disorders
* Pregnancy and lactation
* Contraindications to the use of mannitol, e.g. serum osmolality \> 330, renal failure systemic hypertension, proved intra-cranial brain haemorrhage or sub-dural haematoma and hypotension.
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)

The purpose of this study is to determine whether resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have recently achieved disease control with previous systemic therapy.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients with histologically confirmed MF (Stage IIB-IVB) or SS in an ongoing complete response (CR), partial response (PR) or stable disease (SD) after at least one prior systemic therapy according to local standards (including but not limited to α-interferon, bexarotene, total skin electron beam irradiation, chemotherapy) \[the most recent systemic therapy must have been completed as planned or stopped due to unacceptable toxicity 2-12 weeks prior to randomisation\]
* Eastern Cooperative Oncology Group (ECOG) status score 0-2
* Adequate haematological, hepatic and renal function

Main Exclusion Criteria:

* Patients with progressive disease (PD)
* Baseline corrected QT (QTc) interval \> 500 milliseconds
* Concurrent use of any other specific anti-tumour therapy including psoralen photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy, radiation therapy, or experimental medications
Effect of Different Concentrations of Xylitol and Erythritol on Gut Peptide Release and Gastric Emptying in Humans

Xylitol and erythritol have become increasingly popular as sugar substitutes in the food industry. Both substances are freely available. While glucose ingestion stimulates satiation hormone secretion in the gut and slows down gastric emptying, artificial sweeteners such as aspartame, sucralose and acesulfame-K have no such effect. However, acute intake of 50g xylitol or 75g erythritol in 300mL tap water leads to a marked increase in the satiation hormones and induces a significant retardation in gastric emptying. The concentrations used to Show this effect were rather high (50g xylitol and 75g erythritol) and led to bloating and diarrhea in 60-70% of all subjects two hours after administration. The aim of the present study is to find an effective concentration of xylitol and erythritol still stimulating satiation hormone release without any gastrointestinal adverse events.


Eligibility Criteria:
Inclusion Criteria:

* Healthy normal weight subjects with a body-mass index of 19.0-24.9
* Normal eating habits (no diets; no dietary changes; no special dietary habits, such as vegetarian/vegan)
* Age 18-40 years
* Stable body weight for at least three months
* Informed Consent as documented by signature

Exclusion Criteria:

* Pre-existing consumption of xylitol or erythritol on a regular basis (usage of xylitol or erythritol as sugar replacement; xylitol or erythritol containing toothpaste is allowed)
* Regular intake of medications (except for oral contraceptives)
* Evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other diseases at screening
* Clinically relevant abnormalities in haematological laboratory parameters
* Food allergies, food intolerance
* Pregnancy
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
Postcath Radial Arterial Clamp Time In the CAth Lab

The investigators will assess the effect of different times of radial clamp post procedure on radial artery occlusion and bleeding.

The purpose of this study is to determine the safety of shorter radial artery clamp time post cardiac catheterization with respect to achieving hemostasis and the incidence of radial artery occlusion. The investigators hypothesize that shorter radial artery clamp times following cardiac catheterization will achieve similar hemostasis to longer clamp times with a decrease in the incidence of radial artery occlusion.

Eligibility Criteria:
Inclusion Criteria:

* All patients who require cardiac catheterization via the radial approach for the investigation and treatment of coronary artery disease.
* Patients must have evidence of pre-procedural radial artery patency using Barbeau test.
* Patients must be able to give informed consent

Exclusion Criteria:

* Evidence of pre-procedural radial artery thrombosis
* Inability to give informed consent
* Patient desire not to participate in the study
* Emergent procedures when the delay associated for obtaining informed consent may affect patient outcome
Effectiveness of Puppet Modeling Technique on Children Undergoing Stressful Dental Procedures

The goal of this RCT is to compare puppet modeling technique vs tell show and do on children undergoing stressful dental procedures'

* The main question\[s\] it aims to answer are:

  1. To compare the effect of puppet modeling vs tell show and do on the cooperation of children during the administration of local anesthesia.
  2. To compare the effect of puppet modeling vs tell show and do on the anxiety level of children during the administration of local anesthesia.

type of study: clinical trial participant population/health conditions: Healthy

In this randomized crossover clinical trial, study subjects were randomly allocated into two groups:

* Group I : Children who received puppet behavior guidance during their first visit and tell-show-do guidance in their second visit, 2 weeks later. (P-TSD)
* Group II : Children who received the tell-show-do behavior guidance during their first visit and puppet behavioral guidance in their second visit, 2 weeks later.(TSD-P)

Aim of the Study: The aim of this research is to compare the effectiveness of tell show and do (TSD) vs puppet play therapy on children's behavior during the administration of local anesthesia.

Materials and Methods: This was a randomized crossover clinical trail that was conducted at King Abdulaziz University Faculty of Dentistry for a period of 12 months starting from Jan 2023 to Dec 2023 on 41 children (aged 3-7 years) randomly divided into two groups of. Group I (23 children): Children who received the TSD behavior guidance during their first visit and puppet play therapy in their second visit 2 weeks later. Group II (18 children): Children who received puppet play therapy during their first visit and TSD guidance in their second visit 2 weeks later. The anxiety level was determined using Facial Index Scale(FIS) and Venham anxiety rating scale and pulse rate (PR) at the beginning, middle and the end of each anesthesia administration. Patient behavior was also scored using Frankl behavior rating scale (FBRS) , Venham behavior rating scale. The FLACC scale was used to assess pain.

Eligibility Criteria:
Inclusion Criteria:

* • Children having no previous experience of local anesthesia

  * Children aged 3-8 years old
  * Children with negative history of any particular underlying disease.

Exclusion Criteria:

* • Children who needed procedures with no local anesthesia.

  * Children who were allergic to local anesthesia.
  * Children who were indicated for advanced behavioral guidance.
Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities

The objective of this study is to implement and test the efficacy of the "Summer Harvest Adventure," a comprehensive garden-based behavioral, social, and environmental intervention for children (ages 8-11 years) residing in low-resource communities.

The investigators will conduct a 2-arm randomized controlled trial designed to determine the efficacy of a multifaceted obesity prevention and lifestyle intervention in low-resource children and parent/adult caregiver (PAC) called "Summer Harvest Adventure." A total of 240 children (ages 8-11 years) will be randomized to the garden-based intervention (SHA) or an enhanced control group (MSP). Summer Harvest Adventure includes: 1) remote and group coaching using a focused motivational interviewing approach; 2) weekly fruit, vegetable, and herb harvesting to increase summer food access; and 3) group education for children and their families in a social setting. Assessments for both groups will be collected at orientation held one week prior to the intervention (week 0), and immediately following the completion of the intervention (week 10) by trained personnel that are blinded to participants' treatment arm assignment.

Eligibility Criteria:
Inclusion Criteria:

* Children 8-11 years of age (as of June 1) from assenting and consenting families
* English-speaking families that agree to participate; 3) residents of SNAP-eligible communities in Franklin County, Ohio.

Exclusion Criteria:

* Inability to functionally participate in harvesting; accommodations can be implemented in the future for children with special needs
* Communication difficulties (e.g. severe developmental delay)
* Lack of transportation to weekly classes or harvesting activities
* Non-English speakers; because coaching and classroom-based education are all conducted in English, we will of necessity restrict to English-speakers only during this phase