cyrilzakka/clinical-trials huggingface dataset:
Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)

This study was conducted to determine and compare the safety and effectiveness of two neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are undergoing general elective surgery with sevoflurane anesthesia.

Study participants received an intubating dose of a neuromuscular blocker (to enable insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed, to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular blocker (onset time) after the intubating dose was measured and compared as the primary outcome.

The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular blocking action.

Eligibility Criteria:
Inclusion criteria:

* at least 20 but under 65 years of age
* American Society of Anesthesiologists (ASA) Class 1, 2 or 3 for general elective surgery
* not considered to be pregnant
* scheduled for elective surgery under sevoflurane or propofol anesthesia with an anticipated duration of about 1.5-3 hours
* normal laboratory values

Exclusion Criteria:

* certain medical conditions or medical histories
* receiving certain medications or treatments
The Effectiveness of Using a Single Post-operative Intramuscular Dexamethasone Injection on Patients with Surgical Extraction of Lower Third Molar

Evaluating the effectiveness of using a single immediate postoperative intramuscular Dexamethasone injection on pain, swelling, trismus and tissue healing in the first seven days.

Methods: A split mouth technique on 16 patients with bilateral similar impacted mandibular third molar were extracted; one side was given 8mg intramuscular injection of dexamethasone (study group) and the other side wasn't given injection (control group) and compare of the two sides were done in the following seven days.


Eligibility Criteria:
Inclusion Criteria:

* bilateral similar impacted lower third molar
* willing to do surgical extraction

Exclusion Criteria:

* Patients who are not fulfill the inclusion criteria
* allergic to dexamethasone
* who has medical diseases
* taking any medications
* pregnant or lactating women
Efficacy and Safety of Topically Applied Medical Therapy for the Treatment of Pediatric Glaucoma

Objectives:

The study will assess the ocular hypotensive effect of latanoprost and dorzolamide in a selected sample of patients affected by primary Pediatric Glaucoma (PG), refractory to surgical procedures. Safety will be assessed, too.In the first version of the protocol 96 eyes were forecasted to complete the enrolment. The protocol was then amended and now to complete the study 68 eyes should be included. This number of eyes could be achieved by recruiting from 34 to 68 patients due to not in all patients both eyes should be eligible for the study.

Study design:

Single arm, prospective, experimental study. Due to ethical reasons and in order to adhere as much as possible to current clinical practice, the presence of a control arm is not planned. Due to the non-comparative nature of the study, no blinding of treatment is planned.

Eligibility Criteria:
Inclusion Criteria:

* Children of either sexes, aged 0-12 years
* Diagnosis of mono- or bilateral primary congenital glaucoma
* IOP greater than or equal to 22 mmHg and lower than 27 mmHg
* Only one previous ocular hypotensive surgical procedure for treatment of glaucoma among the following: goniotomy, trabeculotomy, trabeculotomy with adjunct of mitomycin C) (only for medical treatment at least one month before)
* Parent informed consent to data processing (at registration)
* Parent informed consent before any study procedure

Exclusion Criteria:

* Secondary glaucoma (Sturge-Weber syndrome, type I neurofibromatosis, retinoblastoma, steroid-induced glaucoma, etc.)
* Presence of concomitant abnormalities of the anterior segment of the eye (cataract, iridocorneal dysgenesia, congenital uveal ectropion uvea, etc.)
* Previous treatment with the study drugs
* Presence of concomitant systemic diseases (asthma, hypertension, cardiac disease, renal failure, etc.) that needs treatment with drugs, that could influence IOP (steroids, beta-blockers, angiotensin-converting-enzyme inhibitor -inhibitors diuretics, etc.)
* Abnormalities of the cornea that could influence IOP readings (marked cornea edema)
Pre-surgical Antisepsis of Hands After Washing With Triclosan 0.5% Compared to Propan-1-ol 60%

The present study evaluates the effects of bactericidal load reduction after surgical hand scrub antisepsis using the reference antiseptic product propanol-

1 60% as control versus a surgical hand scrub antisepsis with triclosan 0.5% in order to test if pass the standard european norm 12791.

The investigators conducted a crossover clinical trial to evaluate the antiseptic effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by scrub using the reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub antisepsis with trocilosan 0.5% in order to test if pass the standard european norm 12791. Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.

Eligibility Criteria:
Inclusion Criteria:

* Participants without systemic pathologies, with healthy skin of the hands and short fingernails.
* They do not use substances with antibacterial action.

Exclusion Criteria:

* Taken antibiotics before 10 days of the intervention.
* Wear any jewellery on the hands
The Natural History and Prognostic Factors of Compensated Cirrhosis.

Study Design and Methodology

* Study Population:Compensated Cirrhosis
* Study Design: An Ambi Prospective Cohort study
* Study Period: 2 Years
* Sample size: Retrospective- All patients from Jan 2010 to Mar 2017 Prospective- Assuming the incidence of clinical decompensation is 5%/year.With alpha of 5%, power 80% we need to enroll 138 cases. Further assuming 20% drop out 166 cases will be enrolled.
* Intervention: This is an observational study. No intervention will be given.

Monitoring and assessment: All the routine investigation and clinical information will be collected at 6, 12,18 and 24 months.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 75 years
2. Compensated cirrhosis
3. Biopsy proven cirrhosis or LSM \> 12.5 Kpa.

Exclusion Criteria:

1. Any current or prior clinical decompesnation (ascites, jaundice, encephalopathy or gastrointestinal hemorrhage).
2. Pregnant Women
3. Hepatocellular Carcinoma
4. Known case of severe cardiopulmonary disease
5. Known case of severe Hepato Pulmonary Syndrome
Modifications of the Subchondral Bone in Aseptic Osteonecrosis of the Femoral Head

In this study, the aim is to identify the modifications responsible for aseptic osteonecrosis of the femoral head and its structural evolution by the association of the micro scanner analysis and Raman spectrometry performed on the femoral heads removed during hip replacements. The study of femoral heads will allow the analysis of bone tissue at two different scales, both correlated with the biomechanical properties of the bone. Also, the association with preliminary MRI analysis will provide pathogenic explanations correlated to these modifications.


Eligibility Criteria:
Inclusion Criteria for experimental group:

* Men
* Patients aged from 25 to 70 years
* Patient with an aseptic osteonecrosis of the femoral head established by medical Imaging (CT-scan, MRI or radiography)
* FICAT stage 3 or 4
* osteonecrosis etiologies : alcohol, corticosteroid therapy, idiopathic
* Surgical indication of hip prosthesis determined

Inclusion Criteria for control group:

* Men
* Patients aged from 40 to 70 years
* Patient with a primitive coxarthrosis
* Surgical indication of hip prosthesis determined

Exclusion Criteria for the 2 groups:

* Other causes of osteonecrosis (coagulopathy, barotrauma, trauma)
* Prior fracture of the upper extremity of the femur
* Prior cancer and hematological malignancies with bone locations
* Prior debilitating bone diseases
* Patient refusal to participate in the study
* Patient who isn't affiliated to a social security regimen
Impact of Music Intervention on Pain Control In First Trimester Surgical Abortion Under Local Anesthesia

A surgical abortion under local anesthesia is potentially painful. A protocol using analgetic is systematically used. Also the protocol is relevant , the question of taking care of the pain in a safe manner remains.

The use of Music during surgery can have a real effect on pain and anxiety. This study has for goal to evalued the use of music on pain as adjuvant treatement instead of a standard care for an abortion.

A surgical abortion under local anesthesiac is potentially painful. A protocol using analgetic is systematically used. Also the protocol is relevant, the question of taking care of the pain in a safe manner remains.

The use of Music during surgery can have a real effect on pain and anxiety. This study has for goal to evalued the use of music on pain as adjuvant treatment instead of a standard care for an abortion.

The number of patients needed is estimate to be eighty patients per group.

The result of the study could allow :

* Showing the effectiveness of music intervention before operative abortion as adjuvant treatment on the pain, anxiety and nausea during a surgical abortion by suction aspiration under local anesthesia.
* Improving the experience of an abortion and the satisfaction of the patients as well as lowering the use of drugs.

Eligibility Criteria:
Inclusion Criteria:

* Every patients must have more than 18 years old
* Hospitalised at the Angers Hospital for a surgical abortion under local anesthesia.
* Affiliated or be part of the french Sécurité Sociale ( health service )
* To have signed a consent form

Exclusion Criteria:

* Patients not speaking french
* People who should not use music intervention ( Total or partial hearing difficulties)
* No consent given
* Adults protected by the law
* Not being part of another medical study
The Effect of Oxycodone to the Placental Circulation at Early Labour

Oxycodone is used to treat pain in early labor, however the effect of oxycodone to placental or fetal circulation has not been evaluated. Oxycodone is increasingly used to treat labor pain in the early phase. The aim of the randomised, double blinded, placebo controlled study was to evaluate the effects of oxycodone in placental circulation, efficacy and safety of oxycodone and the effects to the newborn.


Eligibility Criteria:
Inclusion Criteria:

* oxycodone planned for pain relief

  * age 18 years or more
  * Informed consent obtained
  * Full term pregnancy

Exclusion Criteria:

* No oxycodone planned

  * age less than 18 years
  * No informed consent
  * not full term pregnancy
* Other contraindication to oxycodone
Compounded Pain Preparation Absorption Study

Single center, prospective, observational study to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications from Medimix Specialty Pharmacy.

Single center, prospective, observational, open-label, cohort study of participants that receive a combination topical pain medication from Medimix Specialty Pharmacy with no comparator group designed to assess serum concentration of ingredients used in multi-ingredient, topical compounded medications.

Eligibility Criteria:
Inclusion Criteria:

* Participants must apply and consistently use the supplied cream for 1 month at a prescribed
* Participants must be ≥ 30 and \<65 years of age
* Participants must be able to provide sound written and verbal informed consent
* Participants must be diagnosed with an ICD9 code indicative of chronic pain

Exclusion Criteria:

* Participants must not have prior hypersensitivity or adverse events to any of the components in the customized prescription
* Participants must not be pregnant or breastfeeding
* Participants must not have used any study drug greater than 180 days from the day of Screening
* Participants must not be utilizing medications that may interact with those being used in the topical formulation as determined by the PI
* Participants must not be using any systemic medications that may influence drug serum concentrations of ingredients being used in the topical compound. These include medications from the same class of studied drugs or drugs that may falsely increase or decrease serum levels of the study drugs
Diabetes Prevention Program in Youth

The purpose of this study is to test the effectiveness of an out-of-school diabetes prevention program for youth (ages 7-15) with a family history of pre-diabetes or type 2 diabetes.

The Insulin Superheroes Club (ISC) is based on the Diabetes Prevention Program for adults (Knowler WC et al., 2002), which was developed by the Centers for Disease Control and Prevention (CDC). We have adapted the curriculum for youth to serve a supplement to the adult program. This program lasts 12 months, and the goals are to improve participants' health and reduce their risk of developing pre-diabetes or type 2 diabetes. The ISC program includes 16 weekly (Phase 1), 3 bi-weekly (Phase 2), and 6 monthly (Phase 3) sessions. Sessions include 60 minutes of physical fitness and 30 minutes of education. The education portion includes interactive teaching of a health-related topic (e.g., nutrition, exercise, physiology, mindfulness, and stress reduction) using a hand-on learning activity (e.g., cooking, crafts, games, and role play). All physical fitness activities incorporate moderate intensity exercises (e.g., push-ups, yoga, basketball, tag, and dance).

Eligibility Criteria:
Inclusion criteria

* Between 7-15 years old
* Parent or grandparent with pre/type II Diabetes
* Able to participate in physical activity
* Parent or caregiver participation

Exclusion criteria

* Pregnant females
* Those with significant physical or mental health illness that would hinder study participation
* Medications that would interfere with testing results
Ventriculomegaly and Gait Disturbance in the Senior Population in the Region of Västerbotten

Idiopathic normal pressure hydrocephalus (INPH) is a treatable disease of the elderly, typically causing gait impariment, dementia and urinary incontinence. The objective of this study is to make an epidemiological survey of INPH in Umeå, Sweden. Subjects with self-perceived gait impairments will be identified through a questionnaire. They will go through clinical examinations and have an MRI of the brain. A control population will also be investigated to enable comparisons between the populations. The main hypothesis is that the prevalence of INPH in the population is higher than what is previoulsy known.


Eligibility Criteria:
Inclusion Criteria:

- Living in Umeå, Sweden.

Exclusion Criteria:

* Age \<65 or \>84 years when the questionnaire was sent out.
* Death at the time for the clinical evaluation.
PCI With AXXESS Biolimus A9 Eluting Bifurcation Stent in Treating Coronary Artery Bifurcation Disease

1. To compare the safety and efficacy of AXXESS stent with conventional DES in patients with coronary artery bifurcation disease
2. To assess the impact of optical coherence tomography (OCT) guidance on clinical outcomes following the stent type


Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures,
* Patients ≥ 19 years old,
* Patients who are expected to undergo PCI for bifurcation lesions.

Exclusion Criteria:

* Age\> 85 years,
* Cardiogenic shock or unstable patients,
* Increased risk of bleeding, anemia, thrombocytopenia,
* A need for oral anticoagulation therapy,
* Pregnant women or women with potential childbearing,
* Life expectancy \< 1 year.
A Study to Investigate the Effect of ACT-132577 on the Pharmacokinetics of Midazolam and 1-hydroxy Midazolam in Healthy Male Subjects

The purpose of this study is to evaluate the effect of ACT-132577 on the pharmacokinetics of midazolam and 1-hydroxy midazolam and to evaluate the safety and tolerability of ACT-132577 when administered alone and in combination with midazolam.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in the local language prior to any study-mandated procedure
* Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
* Healthy on the basis of medical history, physical examination, cardiovascular assessments and serology and laboratory tests

Exclusion Criteria:

* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Finding LCX AMI With Posterior ECG LeadS

Along with symptoms of chest pain, the presence of ST segment elevations on ECG is the criterion usually used in practice to identify patients with acute coronary artery occlusion and is essential for the direct and acute referral of patients for primary PCI. However, ECG does not always reflect changes in the posterior wall of the heart, often equivalent to the left circumflex coronary artery's (LCX) supply area, resulting in an underrepresentation of LCX as culprit artery in STEMI populations. There is a general concern that some patients with genuine acute occlusion of LCX may present without ST segment elevation and be denied reperfusion therapy, resulting in larger infarction and worse outcome.

The aim of this trial is to implement record of posterior ECG leads (V7, V8 and V9) in addition to the standard 12-lead ECG in the pre-hospital setting and to evaluate the clinical impact of this implementation: In comparison to a control cohort of STEMI patients diagnosed with a pre-hospital standard 12-lead ECG prior study start, the investigators hypothesize that introducing V7-V9 leads as a clinical routine in the pre-hospital setting will identify patients with STEMI involving LCX and with a non-diagnostic standard 12-lead ECG.


Eligibility Criteria:
Inclusion Criteria: Intervention group:

* All STEMI patients referred directly from the pre-hospital setting, treated with primary PCI and with available standard 12-lead ECG and ECG with V7-V9 leads.

Exclusion Criteria:

* STEMI patients treated with primary PCI and no ECG with V7-V9 leads.
GIP, GLP-1 and GLP-2 in Type 2 Diabetic Hyperglucagonemia

In order to investigate the mechanisms underlying the hyperglucagonemia characterizing patients with type 2 diabetes mellitus (T2DM) we wish to test the following hypothesis: Do pancreatic alpha-cells exhibit inappropriate glucagon responses to substances released from the small intestine (GIP, GLP-2 and GLP-2) in patients with T2DM?

Patients with T2DM are not able to suppress their secretion of glucagon after a meal or after oral ingestion of glucose. Patients actually respond with pathological high plasmaglucagon concentrations to these stimuli. Previous studies have shown that postprandial hyperglucagonemia results in increased hepatic glucose production and therefore contributes significantly to the hyperglycemia characterizing these patients.

Recently we have shown that patients with T2DM exhibit a normal suppression of glucagon secretion following an adjustable intravenous (iv) glucose challenge mimicking the glucose excursion following a 50-g oral glucose tolerance test (OGTT) with the latter resulting in lack of glucagon suppression. Why this difference? A possible explanation could be that the oral administration stimulates intestinal factors resulting in a differentially glucagon response to the two similar glucose excursions. We wish to establish whether GIP, GLP-1 and/or GLP-2 are responsible for the inappropriate glucagon suppression following OGTT and meals in patients with T2DM.

Eligibility Criteria:
Inclusion Criteria:

* Caucasians with diet and/or tablet treated T2DM of at least 3 months duration (diagnosed according to the criterias of the World Health Organization (WHO))
* Normal Hemoglobin
* Prior Informed Consent

Exclusion Criteria:

* Liver disease (ALAT/ASAT \> 2 x upper normal value)
* Diabetic nephropathy (se-creatinin \> 130 um and/or albuminuria
* Treatment with drugs that cannot be discontinued for 12 hours
Study on the Efficacy of HE and Therapeutic Group Factors on CR and QoL

This randomised study evaluates the efficacy of health education and therapeutic group factors on cardiac rehabilitation and quality of life in coronary patients attending cardiac rehabilitation programmes in Extremadura.

Cardiac rehabilitation has been shown to be effective in improving the quality of life of patients who have suffered a cardiovascular event, as well as in preventing future cardiovascular events, demonstrating an increase in survival of between 20% and 30%, with a Class IA recommendation. Due to the prevalence of cardiovascular disease, both nationally and globally, it is important to study the benefits of these cardiac rehabilitation programmes in order to encourage their use. However, several studies have shown that for the programme to be effective, 5% to 10% weight loss must be achieved in patients, adequate nutritional education must be implemented, and behavioural and psychological intervention programmes must be incorporated in order to have an impact on adherence, psychological well-being, and coping with exercise intolerance. This project aims to study the effectiveness of health education and therapeutic group factors in cardiac rehabilitation and on quality of life in coronary patients in Cardiac Rehabilitation Units in Extremadura, including in the analysis anthropometric and body composition, nutritional, cognitive, emotional and lifestyle factors, which could act as mediators of cardiac function, reactivity to neuro-cardiovascular stress, anxiety, depression, anger-hostility, rehospitalisation, adherence, and adherence to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of coronary heart disease, referred to the "Cardiac Prevention and Rehabilitation Unit".

Exclusion Criteria:

* Patients with disabling psychiatric disorders.
* Existence of pacemaker or automatic defibrillator.
* Presence of pregnancy or breastfeeding.
* Presence of medical conditions related to oncological conditions requiring chronic treatment with drugs or other substances.
* Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.