cyrilzakka/clinical-trials huggingface dataset:
Study to Compare the the Analgesic Efficacy and Tolerability of Meloxicam Versus Placebo and Ibuprofen in the Treatment of Pain After Surgery of the Third Molar

To assess the analgesic efficacy and tolerability of meloxicam 15 mg, 7.5 mg, 3.75 mg and 1.875 mg oral (rapid release tablet) compared with placebo and ibuprofen 400 mg and 200 mg administered in a single dose, over an observation period of 6 hours in the treatment of pain after surgery of the third molar.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 years or above
* Patients undergoing removal of one impacted mandibular third molar under local anesthesia. (Short duration anaesthetics will be allowed, i.e. mepivacaine 3% in Italy and Spain and xylocaine in USA, both without vasoconstrictors) Only patients with type of inclusion II to IV have to be included (type II, molar in the submucosa; type III, molar partially included in the bone; type IV, molar fully included in the bone)
* Assessment of pain must be at least 50 mm on a 100 mm visual analogue scale (VAS)
* Patient informed consent in accordance with local legislation.

Exclusion Criteria:

* Type I of inclusion (molar partially or totally erupted)
* Known or suspected hypersensitivity to trial drug or their excipients, analgesics, antipyretics or nonsteroidal antiinflammatory drug (NSAIDs)
* Any clinical evidence of active peptic ulceration during the last six month
* Recurrent ulcers
* Pregnancy or breast feeding
* Asthma, nasal polyps, angioneurotic oedema or urticaria following the administration of aspirin or NSAIDs
* Concomitant treatment with anti-coagulants (including heparin), lithium
* Concomitant administration of other anti inflammatory or analgesic agents
* Administration of any drug with analgesic properties in the 24 h previous to the administration of the study drug, except the local anesthetic for the surgery
* Administration of any antibiotics
* Significant perioperative complication judged by the oral surgeon
* Clinical evidence of or known severe cardiac, hepatic, renal, metabolic, hematological disease (including bleeding disorders), mental disturbance, ulcerative colitis
* Any other disease that could interfere with the evaluation of efficacy and safety
* Participation in another clinical trial during this study or during the previous month
* Previous participation in this trial
* Patient unable to comply with the protocol
Driving in Mild Dementia Decision Tool

Based on the literature on dementia and driving, and on knowledge tools available to date including one from our current work, a Driving in Mild Dementia Decision Tool (DMD-DT) will be adapted and tailored to guide physicians in their decisions to report a driver with mild dementia to the provincial licensing agency. The DMD-DT intervention will include a) an algorithm-based computerized clinical decision support system (CCDSS) for facilitating driving assessment and physicians' reporting to provincial transportation authorities, b) an individualized educational package for patients and caregivers about dementia and driving and driving cessation, and c) a modified reporting form to provincial driving regulatory authorities. Months 1 to 6: The DMD-DT will be tailored and adapted to practice with the input of the co-investigators and knowledge-users who represent the perspectives of physicians, patients and their caregivers, as well as transportation authorities. Pilot testing will be done, and input from focus groups of knowledge-users will refine the intervention. Physicians will be recruited to participate in a clinical trial of the DMD-DT. Months 7-18: A parallel-group cluster randomized controlled trial (RCT) will be conducted to compare the effects of the DMD-DT to a legislation reminder on recommendations for reporting to the licensing agency. The effects of the DMD-DT on the doctor-patient relationship will be further explored in focus groups and interviews with physicians. Months 19-24: The knowledge obtained from the study will be used to generalize and sustain use of the intervention beyond Ontario, Canada, and to disseminate the information to knowledge-users. The primary outcome measure is the filing of a report to the Ministry of Transportation of Ontario, indicating that the physician has a concern about the patient's health condition (i.e. mild dementia). The primary outcome of the study is the difference in reporting between the DMD-DT and control arms. Since the current reporting rate is low, approximately 13%, from a public health point of view, the primary outcome expected is that physicians in the DMD-DT group will report more patients with mild dementia than those in the control group.

as above

Eligibility Criteria:
Inclusion Criteria:

* family physicians and specialist physicians (geriatricians, geriatric psychiatrists, cognitive neurologists) practicing in Ontario, Canada, who assess and treat patients with mild dementia
* must speak English and have computer access at the point of delivery of care

Exclusion Criteria:

* family physicians must see at least 10 new patients per year with mild dementia, and specialist physicians must see at least 12 new patients per year with mild dementia
* participants must not have participated in, attended a continuing medical education (CME) event about, or read about our "Dementia and Driving in Ontario" study (2010-2012)
Comparison Of Epidural Analgesia Techniques In Percutaneous Nephrolithotomy With Surgical Pleth Index

Primary aim of this study is to evaluate affect of SPI guided antinociception on total intraoperative consumption of local aneshesics during analgesia. Secondary aims are defining time interval between LA administration and SPI value dropping under 50 and hemodynamy. Tertiary results are total mean local anesthesic consumption per hour, mean LA bolus number, total norepinephrine, ephedrine and atrophine consumption, mean intraoperative heart rate, mean arterial pressure, BIS and minimal alveolar concentration, percentage of intraoperative surgery time during which SPI\>50, time passed until first post operative analgesia need, time needed to be discharged from PACU after operation (evaluated via Aldrte score) and post operative side effects (nausea, vomiting, sedatition and piruritis)


Eligibility Criteria:
Inclusion Criteria:

* aged 18-60
* ASA I-III
* grade I unilateral PNL

Exclusion Criteria:

* BMI \> 40 kg/m2
* drug or alcohol abuse history in the last 6 mounts
* chronic opoid usage or had chronic pain longer than 6 weeks
* peripheral and central neurological disorders
* preoperative hemodynamic disorders
* irregular sinus rhythm and pace makers
* diabetes, severe lung and major liver diseases with increasing biluribin
* use of anti-muscarinics, α2-adrenergic agonists, β1-adrenergic agonists, anti arrhythmic; who used chronic psychoactive drugs in last 90 days
* who are pregnant and breast feeding
* not willing to participate
* allergic or intolerant to any of the drugs in the study
* procedures that take less than 2 hours
Mild Water-Filtered Near Infrared Whole-Body-Hyperthermia as an Adjunct in the Treatment of Fibromyalgia

The purpose of the study is to evaluate whether mild walter-filtered near infrared hyperthermia produces an additional benefit when applied as an adjunct to standard multimodal rehabilitation compared to standard multimodal rehabilitation only in patients with fibromyalgia.

Mild systemic heat agents, including infrared whole-body hyperthermia, are used as treatment options in multimodal rehabilitation programs for fibromyalgia in Germany. However, no randomized controlled clinical trial exists on their effectiveness for this condition.

This study is designed as an add-on study to evaluate the additional benefit of mild walter-filtered near infrared hyperthermia and a standard multimodal rehabilitation program compared to a standard multimodal rehabilitation program only. Standard multimodal rehabilitation is configured as usually applied in clinical trials with exercise, cognitive behavioral therapy, and health education as the main treatment components.

Mild walter-filtered near infrared hyperthermia (heating-up to 38.1 degrees C body core temperature followed by a 15-min heat retention period) is administered twice a week over 3 weeks during a rehabilitation hospital stay.

Primary outcome measures are measured at baseline, postintervention, 3 and 6 months postintervention. Analysis is done by intention to treat, for significance testing Repeated Measures ANCOVA is used.

Eligibility Criteria:
Inclusion Criteria:

* participants must meet the American College of Rheumatology 1990 criteria for fibromyalgia
* participants must report a score ≥ 4 on the pain intensity subscale of the Fibromyalgia Impact Questionnaire (range: 0-10)
* participants must report a score ≥ 4 on the normalized physical functioning subscale of the Fibromyalgia Impact Questionnaire (range: 0-10)
* participants must be aged between 18 and 70 years

Exclusion Criteria:

* severe cardiovascular disease
* metabolic disease
* nervous system disorder
* blood coagulation disease
* cancer
* acute inflammatory disease
* status after organ transplantation
* reduced general health (Karnofsky Index ≤ 50)
* pregnant women
* breast feeding women
* persons involved in a pending litigation for early pensioning due to fibromyalgia
* persons planning to apply for a pension due to fibromyalgia
A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas

The first indication of hysterectomies in France are uterine leiomyomas. When they are symptomatic leiomyomas are particularly responsables of an increase of menstruations duration and volume. Echography is the reference exam for the diagnosis. It exists two treatments ways:-firstly progestatives and antifibrinolytics for the treatment of hemorragic symptoms, -secondly LH-RH analogs for the treatment of leiomyomas volume and hemorragic symptoms but just used for a small period because of the risk of osteoporosis.

Different studies with different doses of mifepristone were released. The authors observe a decrease of leiomyomas volume. Based on this experience the present placebo controlled study has for objectives:-to confirm the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease and in symptoms of leiomyomas, - to assess the safety of the treatment. The aim is to avoid or delay the hysterectomy of non menopausal patients. During the study patients will be evaluated with biological exams, clinical exams, echographies, medical interrogations and their diary cards.


Eligibility Criteria:
Inclusion Criteria:

* patients who are willing and able to participate in the study
* patients from whom written informed consent has been obtained
* patients who contribute to the National Insurance Scheme
* patients with an age between 25 and 49 years old
* non menopausal patients
* patients who use a non hormonal contraception
* patients with one or several , interstitial or subserous, uterine leiomyomas
* echographic diameter of leiomyomas must be equal or higher than 30 mm
* leiomyomas must be symptomatic
SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis

Liprotamase consists of 3 soluble, non-porcine digestive enzymes, lipase, protease, and amylase, combined in a fixed ratio. Liprotamase is stable in the stomach and can be formulated without enteric coating for administration either as a capsule or as a dosing solution dissolved in water or juice. The purpose of the present study is to provide efficacy and safety data for a new, soluble formulation of liprotamase, Liprotamase Powder for Oral Solution, in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).


Eligibility Criteria:
Inclusion Criteria:

* For Part A: males or females ≥7 years of age
* For Part B: males or females 28 days to \<7 years
* Diagnosis of cystic fibrosis based on presentation, genotype and/or sweat chloride
* Low fecal elastase
* Fair-to-good nutritional status

Exclusion Criteria:

* History or diagnosis of fibrosing colonopathy
* Distal intestinal obstruction syndrome in 6 months prior to screening
* Receiving enteral tube feedings
* Chronic diarrheal illness unrelated to pancreatic insufficiency
* Liver abnormalities, or liver or lung transplant, or significant bowel resection
Epidemiology and Cost-effectiveness of Out-Of-Hospital Cardiac Arrest in Finland

Observational study of all out-of-hospital cardiac arrest during 6 months in regional areas of Helsinki University Hospital and Kuopio University Hospital from activation of EMS system until follow up to 6 months of survival.Simultaneous observation of out-of-hospital cardiac arrest primary survivors admitted to all Finnish ICUs.


Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest patients

Exclusion Criteria:

* None
Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients

Gait impairment remain one of the main problem for hemiplegic stroke patients. After the 6 first months, stroke patients are classically described with moderate or no improvement. Here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular strengthening program with conventional physiotherapy delivered by the local physiotherapist of the patient, in a very ecological way.

Gait impairment remain one of the main problem for most of chronic hemiplegic stroke patients. After the 6 first months, stroke patients are classically described with moderate or no improvement for motor skills. However, physiothertapy is very often delivered to try to increase motor performance. Here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular strengthening program with conventional physiotherapy delivered by the local physiotherapist of the patient, in a very ecological way. Patients will be randomly affected to one group with the same amount of physiotherapy (at least 3 times weekly for 6 weeks). Assessment will be done blindly by another physiotherapist, before, after the 6-week treatment and 6 weeks later to evaluate immediate and remaining benefits of each treatment.

Eligibility Criteria:
Inclusion Criteria:

* Hemipegia due to ischaemic or hemorrhagic stroke more than 6 months ago
* 1st and unique cerebral lesion (Xscan or MRI)
* ability to walk 15 m with or without cane or crutch
* able to understand and give approved consent
* quadriceps at 3/5 (MRC) or stronger

Exclusion Criteria:

* Current treatment with botulinum toxin for spasticity of the paretic flexor or extensor of the knee
* Cardiovascular disease contra-indicating effort and strengthening
* Pregnancy
* Evolving pathology
* Rheumatic disease of the knee contraindicating strengthening
* Aphasia with severe comprehension impairment
Dialectical Behavioral Therapy Skills for Impulsive Aggression

This trial aims to Study the efficacy of DBT skills for impulsive aggression and executive dysfunctions in drug naïve children who are presented with impulsive aggression and ADHD and attending Child and adolescent clinic at Alexandria university hospitals using weekly group therapy for 8 month and testing pre and posttreatment biomarkers of aggression.


Eligibility Criteria:
Inclusion Criteria:

* Patients from 6 to 13-year-old.
* Patients diagnosed with ADHD and presented with impulsive aggression.
* Commitment to therapy from the child and the parent.
* Written consent of all the children parents.
* Male gender.
* Drug naïve or stopped medications for at least one month.

Exclusion Criteria:

* Patients younger than 6 years of age as it's the starting age for DBT-C.
* Patients who dropped from DBT skills group (missing more than 3 consecutive sessions) whether the child or his parent.
* Patients diagnosed with drug abuse.
* Patients with severe sensory impairment or intellectual disability.
* Drug induced aggression as levetiracetam, topiramate and benzodiazepines.
* Patients diagnosed with Autism spectrum disorder or psychotic disorders.
Multi Station Training in Soccer Players Hamstrings Strain

The study is a randomized controlled trial. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Group A will be the wobble board proprioceptive training program lasting for four weeks, while Group B will be administered the multi-station proprioceptive training program lasting for four weeks.

The objective of the study is to determine the effects of Multi-station Proprioceptive training on hamstring strains in Soccer Players. The study is a randomized controlled trial. Ethical approval is taken from ethical committee of Riphah International University, Lahore. Participants who meet the inclusion criteria will be enrolled and allocated in group A \& B through sealed envelope method by Non-probability Convenient random sampling technique. Group A will be the wobble board proprioceptive training program lasting for four weeks, while Group B will be administered the multi-station proprioceptive training program lasting for four weeks. Outcome measures will be assessed by using NPRS, Sit And Reach Test. Lower Extremity Functional Scale. Proximal Hamstring Injury Questionnaire. Balance Training Tool. The collected data will be analyzed in statistical Package for the social Sciences (SPSS) 25.0 .Parametric ∕non\|-parametric tests will be applied after test normality of data

Eligibility Criteria:
Inclusion Criteria:

* Male football players (trained - not trained) between 14 and 30 years of age, Players with a history of hamstring strain had reduced SLH scores, Players with a history of right knee injury also had reduced SLHB scores on the injured side

Exclusion Criteria:

* Children and older adults, Upper body proprioceptive training, Presence of pain in any part of upper limb,lower limb, trunk or body which can interfere in training session
The Effects of Intraoperative Esketamine on Postoperative Pain and Mood in Patients With Inflammatory Bowel Disease

Crohn's disease (CD) is a chronic inflammatory disease of the gastrointestinal tract with symptoms evolving in a relapsing and remitting manner. Typically, the peak incidence of CD is 18 to 35 years , which means that patients with CD will be plagued by the disease during their most precious years, and nearly 35% of them will develop depressive symptoms. For 70% of patients with CD who need surgery, the incidence of preoperative depression may be higher. The CD cohort with diagnosable psychological condition has been shown to experience a higher rate of disease exacerbation than the CD cohort without psycho complication. At the same time, this depressive mood may make postoperative recovery more difficult, so it is necessary to alleviate postoperative depression.

Ketamine, a widely used anesthetic, is also used to treat depression. The most used ketamine in clinical practice is racemic ketamine, but its use is associated with many complications such as psychotic adverse effects and neurotoxicity. In recent years, S-ketamine has received attention for better efficacy and fewer complications . In 2019, the Food and Drug Administration (FDA) approved S-ketamine nasal spray for the treatment of refractory depression and subsequently received approval from numerous health authorities around the world. This proves that S-ketamine can provide a rapid antidepressant effect in patients with depression in a non-surgical setting. However, it is inconclusive whether S-ketamine affects surgical patients, mainly because of differences in the type of surgery, the dosage administered, the interaction with analgesics, and the evaluation tools implemented. Studies have shown that small doses of S-ketamine in breast cancer surgery and cervical cancer surgery can reduce postoperative depression. However, the effects of S-ketamine on postoperative depression (POD) and pain in patients with CD have not been studied.


Eligibility Criteria:
Inclusion Criteria:

1. subjects who volunteered and signed informed consent for the trial, (b) patients aged between 18 and 60, (c) patients with CD who underwent surgery, (d) American Society of Anesthesiologists (ASA) grade Ⅰ\~Ⅲ, (e) Hamilton depression score 8-24.

Exclusion Criteria:

1. allergy to narcotic drugs or ketamine used, (b) patients with other serious systemic diseases (including severe heart, kidney, and liver disease), (c) chronic opioid therapy (more than twice a week for more than three months), (d) inability to understand the digital pain scale, (e) Hamilton depression score \< 8 or \> 24.
French Cohort of Myocardial Infarction Evaluation

Over the last two decades, considerable progress has been made in the management of Acute Myocardial Infarction (AMI), both in the acute phase and in monitoring beyond the hospital phase. Nevertheless, the evolution of care practices and their impact on the mid- and long-term prognosis of patients admitted to the intensive care unit for acute myocardial infarction remain relatively little studied exhaustively.

The aim of this study is to assess the profile of AMI patients, their management and follow-up in order to evaluate the relationship between these factors and outcomes.

The FRENCHIE registry is a French multicenter prospective observational study. All the eligible consecutive patients admitted within 48 hours after symptom onset in a cardiac ICU for an acute myocardial infarction.

This hospital registry will be linked to the national databases, in order to collect follow-up clinical outcomes and health care consumption.

Eligibility Criteria:
Inclusion Criteria:

* Myocardial infarction (IDM) within 48h of symptom onset, characterized by the typical increased or fall of troponin (or CPKMB) associated with at least one of the following elements :
* Symptoms compatible with myocardial ischemia
* Appearance of pathological Q waves
* ST- T changes compatible with myocardial ischemia (ST segment elevation or depression, T-wave inversion)
* Written consent.
* Covered by French medical insurance ("Sécurité Sociale")

Exclusion Criteria:

* Iatrogenic MI defined as MI occurring within 48h of a therapeutic procedure
* AMI diagnosis invalidated in favor of another diagnosis
Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* pathologic proven colon cancer

Exclusion Criteria:

* Tumor located in distal transverse colon, splenic flexure, and descending colon
* distant metastasis
* acute obstruction and/or perforation
* associated with FAP or HNPCC
* synchronous malignancy
* ASA score 3 or 4
* pregnancy
* no consent
Opioid Induced Bowel Dysfunction in Patients Undergoing Spinal Surgery

In the present study, the primary aim was to evaluate if oxycodone-naloxone combination compared to oxycodone reduced opioid induced constipation in patients with or without chronic opioid treatment undergoing spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* BMI 17 - 35 kg/m2
* elective spine surgery
* informed consent obtained

Exclusion Criteria:

* allergy to the used drugs
* other contraindication to oxycodone medication
* no informed consent