cyrilzakka/clinical-trials huggingface dataset:
Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy

The aim of our study is to identify if there is statistically significant difference in patient reported functional outcomes in cases of unstable ankle fracture managed by ORIF with and without ankle arthroscopy.

Acute ankle fracture is one of the commonest fractures of the lower limb. Anatomical reduction and stable fixation remain the main surgical treatment for unstable ankle fractures . However, its final outcomes are not as good as expected . Fracture malunion, failure to address the disrupted syndesmosis and associated ligamentous or chondral lesions can be reasons for poor surgical outcome.

1-mm of lateral talar shift lead to a 42% increase in contact stress, so the anatomic reduction is critical to the long-term integrity of the joint . It is difficult to assess 1 to 2 mm of mal-reduction with C-arm fluoroscopy. The best assessment of the syndesmotic reduction is performed with axial CT imaging of the ankle.

Ankle arthroscopy is expected to be a more sensitive tool for syndesmotic disruption diagnosis and other intra-articular pathologies and as a guide for anatomical reduction of the syndesmosis . Several studies have reported the incidence of chondral lesions seen during ankle arthroscopy at the time of ankle fracture ORIF, but those studies report the role of arthroscopy as a diagnostic or predictive tool for patient outcome. Very few studies have discussed the rates of arthroscopic intervention, the procedures performed, and the association of these procedures with patient final functional outcomes .

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥16 years of age who will be managed operatively for:

  * rotational ankle fracture Danis-Weber classification B or C fibula fracture
  * fracture dislocation ankle
  * Fractures extending into the tibial plafond,
  * Talus fractures (body or neck) in our institution

Exclusion Criteria:

Pediatric fractures, Polytrauma patients, Fractures managed with closed-contact casting and, patients with lost follow up during this study
Efficacy of Ultrasound in Evaluating Occult Fractures

The purpose of the study is to examine the efficacy and accuracy of Ultrasound in evaluating occult fractures. We want to examine it on children that suffer from suspected fractures of the foot and ankle and the results of the x-ray are either negative or inconclusive.


Eligibility Criteria:
Inclusion Criteria:

* boys and girls aged \<=15 years
* suspected fracture of the wrist or ankle (no later than one week after the injury)
* negative or inconclusive x-ray

Exclusion Criteria:

* unwillingness to sign informed consent
NovoLog Observation Trial in Subjects With Type 1 and Type 2 Diabetes

This trial is conducted in the United States of America (USA). The aim of this trial is to assess control of blood sugar, safety, and patient acceptance of insulin aspart compared to insulin lispro, both in insulin pumps, in standard clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* People with Type I or Type II Diabetes
* 18 Years or Older.
Visualizing Beta Cells After Islet Transplantation

In patients with type 1 diabetes (T1D) that have undergone islet of Langerhans transplantation or are on the waiting list for transplantation, Ga-68-exendin PET imaging is performed to study the visualization of transplanted islet grafts in patients.

Detecting damage to islets with a reliable imaging technique could be important for improving islet survival after transplantation. This could lead to better patient outcomes which would be of great interest for the treatment of type 1 diabetes. In order to assess the possibility of visualizing transplanted islet grafts with Ga-68-NODAGA-exendin-4 PET, a proof-of -concept study is performed in 10 patients with type 1 diabetes who have undergone intrahepatic islet transplantation with biochemically proven functional islet grafts and 5 patients with type 1 diabetes who are on the waiting list for islet transplantation. The investigators propose to determine the uptake of the radiolabeled tracer and compare it to functionality of the islet grafts. These highly relevant data will provide us with more information on the suitability of GLP-1 receptor imaging for monitoring of transplanted islet mass.

Eligibility Criteria:
Inclusion Criteria

Tx-group:

* \>18 years old
* T1D patient undergone islet transplantation
* Clinically proven functional islet graft
* Signed informed consent

Control group:

* \>18 years old
* T1D patients who are on the waiting list for islet transplantation
* Signed informed consent

Exclusion Criteria:

* Treatment with synthetic exendin or Dipeptidyl-Peptidase IV inhibitors within the last 3 months
* Breast feeding
* Pregnancy or the wish to become pregnant within 6 months
* Kidney disease
* Liver disease
* Age \<18 years
* No signed informed consent

Exclusion criteria for MR:

* fragments, clips or devices in brain, eyes, spinal canal
* Implantable defibrillator or pacemaker (wires)
* Mandibular magnetic implants
* Neurostimulator, bladder stimulator, non-removable insulin pump
* Metal tissue-expander in chest
* Cochlear implant
* Ossicular replacement prosthesis
Post-mortem Genetic Testing

This is a prospective observational study to examine the incidence of cardiac ion channelopathies in unexplained still births.


Eligibility Criteria:
Inclusion Criteria:

* Unexplained still births,
* No cause of death after detailed autopsy

Exclusion Criteria:

* Lack of parental consent
Safety, Pharmacokinetics and Pharmacodynamics of BIRT 1696 BS in Healthy Human Subjects

The objectives are:

1. To assess safety, pharmacokinetics, and pharmacodynamics of BIRT 1696 BS in rising single doses.
2. To assess safety, pharmacokinetics, and pharmacodynamics of single dose of 100 mg BIRT 1696 BS after grapefruit juice.
3. To asses safety and pharmacokinetics of single dose of 400 mg BIRT 1696 BS after a 67 g fat and high caloric breakfast.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects as determined by results of screening
* Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
* Age ≥18 and ≤60 years
* Body Mass Index ≥18.5 and ≤29.9 kg/m2

Exclusion Criteria:

* Female subjects who are lactating or of child bearing potential as defined by surgically sterile or post menopausal (no periods for at least 12 months and elevated follicle stimulating hormone with low estradiol while on no estrogen supplementation unless surgically sterile). Females should use barrier contraception (e.g. condoms) prior to administration of study medication, during the study and at least one month after release from the study. Women must have had negative blood pregnancy tests
* Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* Relevant history of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (\< 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial, (\< 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (\< 2 months prior to administration or during trial)
* Smoker (\> 10 cigarettes or \>3 cigars or \>3 pipes/day)
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Use of methylxanthine-containing drinks or foods (coffee, tea, cola, energy drinks, chocolate, etc.), grapefruit or grapefruit juice, alcohol, green tea, or tobacco \< 5 days prior to administration of study drug or during trial
* Blood donation or loss \> 400 mL, \< 1 month prior to administration or during the trial
* Excessive physical activities \< 5 days prior to administration of study drug or during trial
* Clinically relevant laboratory abnormalities
* Any ECG value outside of the reference range of clinical relevance including, but not limited to QRS interval \> 110 ms or QTcB \> 450 ms (males) or QTcB \> 470 ms (females)
* Inability to comply with dietary regimen of study centre
* Inability to comply with the investigator's instructions
Repetitive Transcranial Magnetic Stimulation in Fibromyalgia

The purpose of this study is to determine the analgesic effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation exercises in patient suffering from fibromyalgia.

A double blind clinical trial with two randomized parallel groups:

* Placebo rTMS and rehabilitation exercise
* Active rTMS and rehabilitation exercise

Fibromyalgia is the most frequent chronic diffuse painful disease (3 to 4% of the general population).

Analgesic drugs are widely used in fibromyalgia, pain being the main symptom. However the effectiveness of analgesic drugs is often insufficient.

Among non-drug therapies, rehabilitation exercise plays an important role with a special interest in terms of the quality of life, strain and pain.

More recently the Transcranial Magnetic Stimulation effects have been evaluated in patients suffering from fibromyalgia with a statistically significative analgesic effect.

Both rehabilitation exercise and Transcranial Magnetic Stimulation (rTMS) have shown their respective analgesic effectiveness in fibromyalgia. It now seems important to evaluate the combination of these two therapies.

Main objective: To evaluate the analgesic effect of rTMS in fibromyalgia patients doing rehabilitation exercise.

Primary endpoint:

The evaluation methode used is a visual analog scale (VAS) of pain. Patients will note down every day VAS of over the last 24 hours.

The evolution of the VAS during the treatment period with respect to baseline, will be compared in both groups, active rTMS and placebo rTMS.

The investigators will analyze the average daily VAS for different weeks (W2, W4, W8, W14) compared to the average daily VAS at the baseline.

After a baseline period of 15 days, patients will begin sessions of rTMS and rehabilitation exercise for a period of 14 weeks.

The study is composed of three assessment visits : a baseline visit, a visit corresponding to the end of the therapy with exercise period and a last assessment visit at 26 weeks after the end of the treatment.

These visits will include clinical examination, blood test, an effort test, an orthostatic test, a resistance to fatigue test and polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* primary fibromyalgia according to the American College of Rheumatology
* no contraindication to rehabilitation exercise
* pain with VAS \> 4 during at least six months
* FIQ score \> 50
* no change in drug therapy over the last month
* affiliation to French Health Service

Exclusion Criteria:

* BMI \> 35kg/m²
* patient who has already benefited from rTMS
* rTMS contraindication
* restless legs symptom
* patient suffering from major depression
* patient suffering from inflammatory rheumatism, autoimmune disease, other chronic pain pathology
* sleep apnea syndrome
* no contraindication to rTMS or MRI
* pregnant women
European Trial of Dronedarone in Moderate to Severe Congestive Heart Failure

The purpose of this study is to assess the efficacy, tolerability and safety of dronedarone versus placebo in patients with symptomatic congestive heart failure (CHF) and left ventricular dysfunction (LVD) when added to evidence based treatments for CHF.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized with symptomatic CHF, current New York Heart Association (NYHA) class II-IV requiring treatment with a diuretic, who had had within the last month at least 1 episode of dyspnea or fatigue at rest, or on slight exertion corresponding to NYHA class III or IV
* Wall motion index (WMI) ≤1.2 determined by a blinded central evaluation of a recorded standard echocardiography, equivalent to a left ventricular ejection fraction (LVEF) ≤35%.

Exclusion Criteria:

* acute pulmonary edema within 12 hours prior to start of study medication
* various heart conditions (cardiogenic shock, obstructive valvular disease, obstructive cardiomyopathy; acute myocardial infarction, cardiac surgery, acute myocarditis or constrictive pericarditis, history of torsades de pointes, bradycardia \<50 bpm and/or PR-interval ≥280 ms, QTc-interval \>500 ms, significant sinus node disease)
* any illness or disorder other than CHF (cancer with metastasis, organ transplantation)
* current participation in another clinical study or currently taking an investigational drug including dronedarone or concomitant prohibited medication or treatment with other class I or III anti-arrhythmic drugs
* pregnant and/or breastfeeding women or women of child-bearing potential without adequate birth control
* serum potassium \<3.5 mmol/L.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of Carbon-14-Labelled [14C] LY3372689 in Healthy Male Participants

The main purpose of this study is to evaluate how much of the study drug (LY3372689), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream, how its broken down, and how long it takes the body to get rid of it. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Male participants who are overtly healthy as determined by medical evaluation
* Have a body mass index within the range 18.5 to 32.0 kilograms per meter squared (kg/m²)
* Males who agree to use highly effective/effective methods of contraception for 14 weeks following the dose of LY3372689 may participate in this trial.

Exclusion Criteria:

* Have a clinically significant abnormal blood pressure and/or pulse rate as determined by the investigator at screening or check-in
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Have evidence of significant active neuropsychiatric disease, as determined by the investigator
* Have participated in \>3 radiolabeled drug studies in the last 12 months
Biomechanical Properties of the Lumbar Paravertebral Muscles

Cesarean delivery (CD) is an obstetric surgery for fetal delivery that involves both an abdominal incision (laparotomy) and a uterine incision (hysterotomy). It is presently the most prevalent surgery in the United States, with over 1 million women giving birth by cesarean section each year.

The anaesthetic types of choice for cesarean delivery are neuraxial and general anaesthesia.

Neuraxial anesthesia is the gold standard anaesthesia for CD; it includes spinal and epidural anaesthesia. For spinal anaesthesia, local anesthetics are injected into the spinal canal, while for epidural anaesthesia, they are injected into the epidural space.

Despite the superiority of neuraxial anaesthesia for cesarean delivery, general anesthesia is still performed to some extent especially when neuraxial anaesthesia is failed or inconsistent.

General anesthesia involves a transient state of unconsciousness through the administration of inhaled anesthetic gases combined with intravenous drugs.

LBP patients showed changes in their neuromuscular activity, reduction in the lumbar muscle flexibility, and alteration of the biomechanical properties of the lumbar muscles.

Eligibility Criteria:
Inclusion Criteria:

1. All women gave birth through a cesarean delivery.
2. All women either primiparous or multiparous have not had anaesthesia (epidural, spinal, or general) for at least one year prior to the last obstetric anaesthesia.
3. Their ages ranged from 18 to 35 years.
4. All participants had a body mass index (BMI) of not more than 30, and a waist-to-hip ratio of not more than 1.
5. Participants were assessed between the 6th week to the 12th week postnatal.
6. All participants were able to continue all assessment procedures.
7. They were medically stable.

Exclusion Criteria:

1. Women who delivered through vaginal delivery.
2. Women who delivered through cesarean delivery, but the used anaesthetic technique was the paramedian approach for either the epidural or spinal anaesthesia.
3. Women with urinary tract infections.
4. Women who were below 18 years old or above 35 years old.
5. Women who had a (BMI) above 30 or a waist-to-hip ratio above 1.
6. Women who did not continue all assessment procedures.
7. Women who had any specific low back pain as women who were diagnosed with lumbar disc prolapse, scoliosis, or spondylolisthesis.
Trial Evaluating the Efficacy of the Combination of ROpivacaine With Reference XYlocaine in the Evaluation of Pain During the Installation of Percutaneous Radiological GASTrostomy

Gastrostomy is an intra-gastric nutritional enteral device that could be put in place by percutaneous technique under radiological guidance: allowing local anesthesia. However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action. The association of these two drugs could enhance the analgesia post procedure. The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.

Gastrostomy is an intra-gastric nutritional enteral device, allowing the nutritional support for patients presenting oral feeding disorders. Gastrostomy could be put in place by different manners:

* Chirurgical technique or endoscopy: with general anesthesia;
* Percutaneous technique under radiological guidance: allowing local anesthesia. This last one is better tolerated by weak patients, and involves less complication.

However, there is no clear recommendation about local analgesia during this exam. Operator can chose Lidocaine with a short period of action, or Ropivacaine with a longer period of action.

The association of these two drugs could enhance the analgesia post procedure. Indeed, pain felt during the twenty four hours post procedure seems to be the most frequent adverse effect reported by patients.

Pain could decrease significantly when Ropivacaine is added to the reference Xylocaine. Ropivacaine had already proved its efficacy in association with other antalgics.

The main objective of this study is to decrease maximal pain felt during a twenty four hour stay, after a gastrostomy under percutaneous technique with radiological guidance.

Eligibility Criteria:
Inclusion criteria :

* Major patient;
* Having an indication for placement of PRG (percutaneous radiological gastrostomy);
* Patient hospitalized for a minimum of 24 hours post gastrostomy;

Non-inclusion criteria :

* Pregnant or lactating woman;
* Legal incapacity or limited legal capacity. Medical or psychological conditions which do not allow the subject to understand the study and sign the consent (art. L.1121-6, L.1121-7, L.1211-8, L.1211-9);
* Not knowing how to read and / or write French;
* Allergy and / or known hypersensitivity to lidocaine and / or ropivacaine or to other local anesthetics with amide bond or to one of the excipients;
* Recurrent porphyrias (genetic, hereditary diseases affecting the production of hemoglobin);
* Patient on beta blockers during the installation of PRG (Percutaneous Radiological Gastrostomy);
* Indication of gastrostomy button placement.
Cardioprotective Activities Of Whole Eggs On Vascular Endothelial Function In Prediabetic Adults

Cardiovascular disease (CVD) is largely a lifestyle-related condition that is the #1 killer of adults in the United States. Our work is aimed at understanding how short-term increases in blood sugar, like those that accompany eating a meal, affect blood vessel function and the risk of CVD. This research is aimed at understanding how meals composed of eggs affect short-term increases in blood sugar from eating, which are connected with increased risk of CVD. In particular, the investigators are trying to identify a specific meal composed of either whole eggs, egg yolks, or egg whites, that best reduces acute increases in blood sugar brought on by meals that consist of majority carbohydrate. At the same time, the investigators are trying to explore the protective affects that eggs may have on blood vessel function and the reduction of CVD risk.

Cardiovascular disease (CVD) is the leading cause of death in the United States \[1\]. The inability of your blood vessels to properly enlarge and shrink, known as vascular endothelial dysfunction (VED), is an early event leading to CVD and can be caused by postprandial hyperglycemia (PPH) \[1\] or short-term increases in blood sugar that occur after you have eaten. Although we do not know how this occurs, research shows that temporary increases in blood sugar impair the blood vessel's ability to properly enlarge and shrink. We also know that impaired vessel function is an early event leading to CVD and that research shows that short-term increases in blood sugar impair blood vessel function, even in healthy people \[2\].

Because high blood levels of cholesterol increase CVD risk, this has triggered flawed guidelines to restrict cholesterol in our diet \[3\], including limiting egg consumption. The misguided fear towards eating eggs has been routinely challenged by large-scale studies failing to associate eggs with heart disease risk \[4-8\]. Research shows that eggs improve the functioning of insulin to reduce blood sugar \[9\]. They also contain bioactive peptides that may attenuate oxidative stress \[10-11\]. This provides rationale for their study as a dietary strategy to reduce PPH and VED. Thus, the objective of this study is to define the potential benefits of eggs and its components (egg yolk and egg whites) on blood vessel health in adults with prediabetes.

Eligibility Criteria:
Inclusion Criteria:

1. fasting glucose 100-125 mg/dL,
2. non-dietary supplement user,
3. no medications affecting vasodilation, inflammation, or energy metabolism,
4. no CVD,
5. nonsmokers,
6. individuals having blood pressure \<130/85 mmHg and total cholesterol \<240 mg/dL.

Exclusion Criteria:

1. unstable weight (±2 kg),
2. vegetarian or egg allergy,
3. alcohol intake \>3 drinks/d or \>10 drinks/wk), or
4. ≥7 h/wk of aerobic activity.