cyrilzakka/clinical-trials huggingface dataset:
The Effects of Lower Right Limb Orthopedic Immobilization on Driving Performance

Abstract Background: Effects of orthopedic immobilizations of the lower right limb on driving performances are unknown. Therefore, clinicians and legislators cannot put forth recommendations for road safety for patients requiring such immobilizations. The objective of the present study was to evaluate the effects of different orthopedic immobilizations on braking performances in simulated driving conditions.

Methods: The braking performances of 48 healthy volunteers were evaluated under 3 conditions: wearing their running shoes, and 2 types of orthopedic immobilizations of the lower right limb, a walking cast and an Aircast walker. A computerized driving simulator was used to measure the maximum force applied on the brake pedal during braking, the braking reaction time and the total braking time during emergency braking with and without a distracter.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between 25 and 60 years old
* Valid Québec driving license
* Driving for at least five years
* Must used exclusively the right foot for accelerating and braking

Exclusion Criteria:

* Non-compensated visual acuity deficits or other visual problems
* Drug or alcohol abuse
* Use of psychotropic drugs
* Central nervous system illnesses such as epilepsy
* Sleep issues
* Metabolic problems
* Cardiovascular disease
* Cerebrovascular disease
* Peripheral vascular disease
* Psychiatric illness
* Renal disease
* Musculoskeletal disease
* Motion sickness and
* Simulator sickness
IV and Intrathecal Ketamine in Cesarean Section

In the current study, the investigators will compare the effects of low-dose intravenous (i.v.) ketamine versus intrathecal Ketamine added to spinal anesthesia on the time to first request for analgesia and maternal pain scores and overall satisfaction in patients undergoing cesarean section.


Eligibility Criteria:
Inclusion criteria:

• Pregnant undergoing elective cesarean section

Exclusion Criteria

* Significant coexisting diseases (pregnancy-induced hypertension or diabetes)
* body mass index ≥40kg/m2, height \<150cm
* Current use of pain medication including opioids
* history of substance abuse or hallucinations, cardiovascular disease, diabetes, multiple gestations
* chronic pain was excluded.
* contraindications to spinal anaesthesia,
* severely compromised fetus requiring general anesthesia and those patients who received labor analgesia
The Relation Between Serum Level of Amioterminal Propeptide of Type I Procollagen and Diastolic Dysfunction in Hypertensive Patients Without Diabetes Mellitus

In the present study, we assessed the relation between diastolic dysfunction and myocardial fibrosis in hypertensive patients without diabetes mellitus. A total of 20 medically treated ambulatory non-diabetic hypertensive patients with normal left ventricular (LV) systolic function were enrolled into this study. Myocardial fibrosis was evaluated by serum concentrations of amino-terminal propeptides of type I and III procollagen (PINP and PIIINP). All patients underwent examinations of diastolic function by echocardiography and technetium-99m (99mTc) radionuclide ventriculography. There were 8 patients with PINP ≦53 μg/l (group 1) and 12 patients with PINP \>53 μg/l (group 2). Patients in group 2 had significantly lower LV peak filling rate (PFR; 3.2 ± 0.3 vs. 2.5 ± 0.2 end-diastolic volume/s) and shorter time to PFR ( 257 ± 41 vs. 174 ± 22 ms). Besides, the group 2 patients also had lower right ventricle PFR (1.9 ± 0.2 vs. 1.5 ± 0.1 end-diastolic volume/s) and shorter time to PFR ( 221 ± 29 vs. 154 ± 29 ms). Echocardiographic parameters for LV diastolic dysfunction (E/A ratio of mitral flow, deceleration time of E flow, velocities of pulmonary venous flow \[retrograde A wave, systolic /diastolic velocity ratio\], isovolumetric relaxation time, Tei index) were all comparable between two groups. In multiple regression analysis, LV time to peak filling rate was the only parameter that independently predicted serum PINP level (p\<0.05). In conclusion, elevated serum PINP level reflected LV diastolic dysfunction in hypertensive patients without diabetes.


Eligibility Criteria:
Inclusion Criteria:

* We enrolled 20 medically treated ambulatory, non-diabetic, hypertensive patients in this study.

Exclusion Criteria:

* Patients with abnormal liver functions, leukocytosis, elevated serum levels of C-reactive protein, systolic dysfunction (LV ejection fraction \<50%) and LV hypertrophy due to etiologies other than hypertension were excluded from this study.
Safety and Efficacy of MBI 226 2.5% and 5.0% Topical Acne Solutions in the Treatment of Acne

This study investigates the safety and efficacy of MBI 226 2.5% and 5.0% Acne Solutions, applied topically for six weeks, in the treatment of acne.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, ages 13 and up, exhibiting high levels of facial P. acnes
* Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

* Acne conglobata, acne fulminans, or secondary acne (chlorine, drug-induced acne, etc.)
* Active facial cysts
Safety, Toleration and Pharmacokinetics of Single Intravenous Doses of Peptide YY in Overweight Adults

The purpose of this trial is to evaluate the safety and tolerability of single escalating doses of Peptide YY3-36 and to determine effects on food intake and serum hormones when administered by intravenous infusion to otherwise healthy overweight adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI 27-35 kg/m2

Exclusion Criteria:

* Women of childbearing potential
Evaluation of Non Inferiority of Non Capsular Suture in Femoroacetabular Impingement Arthroscopic Treatment

Since last past decade, arthroscopic hip surgery proved its efficacy in femoroacetabular impingement treatment. However, no consensus exist concerning capsular suture or not. According to capsular incision size, articular instability can persist if no suture is performed. In contrast, tightly suture can cause post-operative joint stiffness.

This study aims to evaluate the non inferiority of non capsular suture after hip arthroscopy treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up.

Main Objective :

Non inferiority evaluation of non capsular suture after hip arthroscopy treatment of cam or mixed-type femoroacetabular impingement, without hip dysplasia, after 2 years follow-up.

The primary study endpoint is the patient reported outcomes (HAGOS score; iHOT-12 and MHHS) at 2 years follow-up.

Secundary objectives :

* Clinical results at 6 month and 1 year follow-up
* Specific complications occuring and frequences
* Patient quality of life,
* The return to sport,
* Sport level after surgery compare to sport level before surgery
* Pain

Eligibility Criteria:
Inclusion Criteria:

* patient \< 18 years old
* Patient who can be followed for 2 years
* Patient with confirmed diagnostic of femoroacetabular impingement came or mixed-types, without dysplasia and with VCE angle \> 25°, without prearthrosic lesion and Tonnis 0 ou Tonnis 1, radiographic assement
* Patient must sign an informed consent form indicating that he or she understands the purpose of procedure required for the study and accepts to participate in the study.
* Patient affiliated to a social security system

Exclusion Criteria:

* Patient with no wittren informed consent
* Patient presenting osteoarthritis (Tonnis stage 2) or only pincer impingement
* Hyperlaxity
* Dysplasia (VCE \<25°)
* Patient already underwent hip arthroscopy
* Patient already underwent previous hip surgery
* Patient needing bilateral hip arthroscopy \< 2 years
* Persons deprived of their freedom or under guardianship or incapable of giving consent
Observational Biologic or Prosthetic Mesh

The purpose of this study is to assess the incidence of hernia recurrence with the use of biologic and prosthetic mesh in ventral hernia repair.

Incisional hernias are very common, leading to over 380,000 operative repairs done annually. Despite the commonality of this problem, there has been no single operative repair that has become the standard. This is due to the high recurrence rates with all types of repairs, especially primary suture repair. Because of this, most repairs are done with some type of mesh, either made out of a prosthetic material or biologic material. Mesh repairs, however, have their own problems, namely surgical site infections and potential bowel erosion. Potential complications associated with prosthetic mesh for hernia repairs include: adverse reactions to the mesh, mesh erosion, stricture formation, adhesions resulting in bowel obstruction, enterocutaneous fistulas, injuries to nearby organs, nerves or blood vessels, infection, chronic pain and hernia recurrence. Potential complications associated with biological mesh include: adverse inflammatory response, laxity, eventration, and recurrent herniation. To address these mesh related complications, the separation of components technique was developed to reduce tension on the midline repair and the underlay technique was developed to place the mesh in the retrorectus space. Nevertheless, this technique still has a significant recurrence rate.

Therefore, the purpose of this study is to evaluate the effectiveness of biological or prosthetic mesh in incisional hernia repair, by assessing the associated rates of hernia recurrence and complications.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients \> 21 years old.
* Able to provide informed consent in English or Spanish.
* Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study, if applicable.
* Allergy or hypersensitivity to materials in porcine-based study products, prosthetic or biological meshes, or personal preference.
* Male and female patients ≤ 21 years old
* History of drug addiction (recreational drugs, prescription drugs or alcohol) that in the Investigator's opinion may interfere with protocol assessments and/or the subject's ability to complete the required follow up.
* Serious or active medical or psychiatric condition which, in the opinion of the Investigator, may interfere with treatment, assessment, or compliance with the protocol.
Levetiracetam for Benign Rolandic Epilepsy

This study is designed to test if the language problems commonly seen in children with benign rolandic epilepsy would improve by switching anticonvulsants to levetiracetam.

This is a 6 month study in which children on another anticonvulsant would have EEG, language testing, and a clinic visit at baseline. They would then be rapidly transitioned off of their current anticonvulsant and onto levetiracetam (Keppra). Repeat EEG and language testing would be done after 6 months to evaluate for improvement.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6-12
* Benign rolandic epilepsy
* Language difficulties as reported by parents or teachers
* On another anticonvulsant other than levetiracetam

Exclusion Criteria:

* Prior use of levetiracetam
* On 2 or more anticonvulsants
* Language problems prior to epilepsy
* Another seizure disorder
* Status epilepticus within the past 6 months
* Significant psychiatric disease
* Progressive neurologic disease
Study on Sotrovimab and Its Impact on the Immune Response to COVID-19 Infection in Real-life in the UAE and Bahrain

The United Arab Emirates (UAE), the Kingdom of Bahrain, Kuwait, Oman, and Qatar have authorised sotrovimab for emergency use. Local experience among physicians include recent successful COVID-19 vaccine pivotal studies supported by the authorities' willingness to expedite understanding of the role of monoclonal antibodies such as sotrovimab in the management of COVID-19 and expertise to integrate the latest knowledge into the local or regional COVID-19 management guidelines. The aim of this study is to collect local clinical evidence for sotrovimab effect in the real-life setting in the UAE and the Kingdom of Bahrain. Overall study population is 20,000 and the duration of the study will be approximately six months from recruitment date.


Eligibility Criteria:
Inclusion Criteria:

* Adults and paediatric patients (≥ 12 years of age weighing at least 40 kg)
* Mild-to-moderate COVID-19
* Positive results of direct SARS-CoV-2 viral testing
* High risk for progression to severe COVID-19

Exclusion Criteria:

* Patients who are hospitalised due to COVID-19 before sotrovimab administration
* Patients who require oxygen therapy due to COVID-19 before sotrovimab administration oPatients who received pharmacological treatment including monoclonal antibodies to any components of SARS-CoV-2 virus within 6 months prior to enrolment into the study in retrospective and prospective arms.
Comparison of Two Pain-treatment Techniques After Tympanomastoid Surgery Pain

Analgesia following tympanomastoid surgery is critical for the prevention of postoperative . There are very few regional anesthesia methods used to achieve this goal.

In this study, it was aimed to investigate the effect of Ultrasound guided superficial cervical plexus block versus greater auricular nerve block for on postoperative tympanomastoid surgery analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Tympanomastoid surgery.

Exclusion Criteria:

* Previous history of opioid use preoperatively,
* Allergy to local anesthetics,
* The presence of any systemic infection,
* Uncontrolled arterial hypertension,
* Uncontrolled diabetes mellitus.
Desflurane and Sevoflurane on Remifentanil Requirement

The primary purpose of this study is to compare the desflurane and sevoflurane on remifentanil requirement using analgesia nociception index-guided anesthesia in patients undergoing spine surgery.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of herniated disc, injury of spinal cord, and neoplasm of spinal meninges

Exclusion Criteria:

* Hyperbilirubinemia
* Prior chronic pain
* Prior opioid abuse
* Cardiac arrythmia
Analytical Validation of the abioSCOPE Device With an IgE Test Panel: Point-of-Care Precision, Sample Type Comparison and Method Correlation

This is a multicenter, prospective, observational study to evaluate the analytical performance of the Abionic IgE Multi-Allergen Test Panel on the abioSCOPE® device in a U.S. point-of-care environment within a clinical laboratory operating under a CLIA certificate for tests of moderate complexity. The study will assess point-of-care ('external') precision, sample type comparison and correlation with a reference method (Phadia Laboratory System, ThermoFisher Scientific).


Eligibility Criteria:
Inclusion Criteria:

* Provision and understanding of signed and dated written informed consent by the subject prior to any mandatory study-specific procedures, sample collection, or analysis.
* Male or female, 18 years of age or older.

Exclusion Criteria:

* Subject participating in another study that may influence test results.
* Subject taking any of the following medications: systemic steroids (inhaled or nasal steroids are allowed), anti-cytokines or cytokines, systemic interferon (injection local interferon α for the treatment of HPV is allowed), anti-IgE therapy (approved or investigational) or treated with systemic chemotherapy.
* History of cancer, autoimmune, or immune deficiency disease.
* Suffering from a hematological pathology (coagulation disorder, severe anemia) that could interfere with the blood draw procedure.
No Axillary Surgery for Early Breast Cancer.

After breast cancer (BC) screening was introduced for all Swedish women in 1989-90 the number of early invasive BC, clin N0 rose dramatically. For these BC it was known that only 10 % or less was N+ after axillary dissection and the morbidity for axillary surgery was substantial. Omitting axillary dissection in a randomized trial was ruled out because of anticipated few events. A national cohort was decided for invasive unifocal BC, histological grade 1 or 2, T=max 10mm, free margins, clin node neg. No axillary dissection should be undertaken. This was before the Sentinel Node era. Adjuvant treatment could be given according to regional guidelines for early breast cancer. Not uniform concerning postoperative radiotherapy and antihormonal treatment. Follow-up was clinical the first 5 years with mammography and then by hospital records and national Death register. Primary aim: Number of axillary recurrence and BC specific survival.

After national breast cancer screening was introduced in Sweden in 1989-90 the number of early invasive BC, clin N0 rose dramatically. Only 10 % or less of these was N+ after axillary dissection with a substantial morbidity after the axillary intervention. Omitting axillary dissection in a randomized trial was ruled out because of anticipated few events. A national cohort was decided for invasive unifocal BC, Screening or clinical diagnosis were eligible, only histological grade 1 or 2, T=max 10mm, free margins , clinical node negative. No axillary dissection should be undertaken, only radical removal of the breast cancer. (Note; This was before the Sentinel Node era). Adjuvant treatment could be given according to regional guidelines for early breast cancer as no regular national guidelines existed then concerning postoperative radiotherapy and antihormonal treatment. Chemotherapy was not recommended to this type of breast cancer. Follow-up was done by the treating surgeon the first 5 years including mammography. Then hospital records including mammography and reports from Pathology and Oncology and Death register were followed at intervals 5, 10 and 15 years. Primary aim: Number of axillary recurrence and distant metastases/ BC specific survival. Correlation to adjuvant therapy. Inclusion started in 1997 and ended in 2002. 1584 patients were included. If the axillary recurrence rate was more than 1% per year the first five years the inclusion should be stopped.

Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer, unifocal
* T=max 10mm
* Clinical node negative and clinical M0
* Histological grade 1 or 2
* Both screening / clinical detected accepted
* Radical operation = free margins in breast specimen
* Partial mastectomy and mastectomy accepted
* Fit to understand inclusion criteria

Exclusion Criteria:

* Previous breast cancer diagnosis, including carcinoma in situ
* Previous ipsilateral axillary dissection
* Non radical operation = no free margins
* Multifocal cancer
* Previous treatment for other cancer.
* Unable to understand information (informed consent)
* Bilateral breast cancer at diagnosis
Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease

The purpose of this study is to assess the efficacy of N-acetylcysteine (NAC) in preventing those with mild or moderate COVID-19 from progressing to severe disease

After being informed of the study and potential risks and benefits, patients meeting eligibility requirements will be randomized to receive oral N-acetylcysteine (NAC) as follows:

Inpatients:

* N-acetylcystine (NAC) 25 mg/kg PO (rounded up to the nearest 600 mg) q4hrs until discharge
* N-acetylcysteine (NAC) 1200 mg PO BID x 1 week post-discharge

Outpatients:

- N-acetylcysteine (NAC) 2400 mg PO x 1 then 1200 mg PO BID x 2 weeks

Eligibility Criteria:
Inclusion Criteria:

* known or suspect COVID-19 disease AND one or more of the following influenza-like symptoms, including: diarrhea vomiting fever (subjective or measured) chills myalgias fatigue sore throat headache cough nasal/sinus congestion or rhinorrhea shortness of breath chest pain

Exclusion Criteria:

* Minors, pregnant women and people unable to provide informed consent are excluded from this study
Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered subcutaneously, at two different dose levels, in healthy Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male Japanese subjects defined as: Subjects born in Japan, time residing outside of Japan does not exceed 5 years, both parents and all 4 grandparents of Japanese descent
* Body weight between 50 and 100 kg, both inclusive
* Body mass index (BMI) between 18.0 and 30.0 kg/m\^2, both inclusive

Exclusion Criteria:

* Male subjects who are sexually active and not surgically sterilised who, or whose partner, are unwilling to use two different forms of effective contraception, one of which has to be a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for 3 months following the last dose of trial medication
* Planned surgery 30 days prior to trial product administration and/or during the entire trial period
* Known hepatic dysfunction during the last 12 months prior to screening (Visit 1)
* Positive urine test for drugs of abuse
* Active hepatitis B and/or hepatitis C infection
* Positive for human immunodeficiency virus (HIV)
* Subjects with clinical signs of thromboembolic events, considered to be at high risk of thromboembolic event or subjects with a known first degree family history of thromboembolism
* Participation in any other trial investigating other products or involving blood sampling within the last 30 days prior to screening
* Use of non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (ASA), but not ibuprofen and cyclooxygenase-2 (COX-2) specific inhibitors within 2 weeks prior to trial product administration (Visit 2)
* Positive alcohol test at screening (Visit 1) and/or history of alcohol or drug abuse within the last 12 months prior to screening (Visit 1)
* Smokers; defined as tobacco users smoking more than 5 cigarettes per day or the corresponding amount of tobacco consumption
* Blood donation within the last 3 months prior to screening and/or during the entire trial period
* Strenuous exercise (as judged by the trial physician) within the last 4 days prior to screening (Visit 1)
Mechanisms Underlying Drug-Diet Interactions

Similar to the well publicized "grapefruit juice effect", ongoing studies are evaluating the interaction potential of other dietary substances on drug disposition. This study is designed to determine whether the mechanism underlying the enhancement of the anticoagulative effect of warfarin by cranberry juice is due to inhibition of warfarin metabolism by the juice. A secondary objective is to determine whether cranberry juice elicits a grapefruit juice-type interaction with midazolam.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* Healthy
* Not taking medications known to modulate CYP2C9 and CYP3A activity
* Able to understand the consent process

Exclusion Criteria:

* Allergy to cranberry products, warfarin, vitamin K, or midazolam
* Pregnant or breast-feeding women
* Baseline INR \>1.2
* History of significant medical conditions that could increase risk
* Concomitant medications known to modulate CYP2C9 and CYP3A activity