cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence of Two Lispro Formulations

This study will compare how the body treats 2 different forms of insulin lispro and how they affect blood sugar levels.

The 2 formulations of insulin lispro will be referred to here as:

Lispro A

Lispro B

Eligibility Criteria:
Inclusion Criteria:

* Are healthy males or females.
* Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m\^2)
* Are nonsmokers.
* Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and clinical laboratory test results within normal reference range at screening.

Exclusion Criteria:

* History of first-degree relatives known to have diabetes mellitus.
* Evidence of significant active neuropsychiatric disease.
* Evidence of an acute infection with fever or infectious disease.
* Intend to use over-the-counter or prescription medication (apart from vitamin/mineral supplements, occasional paracetamol, or birth control methods).
* Have used systemic glucocorticoids within 3 months prior to entry into the study.
* Have donated blood of 1 unit or more within the last 3 months prior to study entry.
* Excessive alcohol intake
* Have a fasting venous blood glucose (FBG, plasma) \>6 millimoles/liter (mmol/L) at screening.
* Have positive hepatitis B surface antigen.
NEFA (Non Esterified Fatty Acid) , Adipose Factors Behind Insulin Sensitivity

We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).


Eligibility Criteria:
Inclusion Criteria obese:

* Bariatric surgery with laparoscopic gastric by-pass

Exclusion Criteria obese:

* diabetes mellitus typ 2 with insulin treatment and/or glitazones
* oral or parenteral steroid treatment
* complicated psychiatric disease
* Warfarin use

Inclusion Criteria non-obese controls:

* BMI under 30

Exclusion Criteria non-obese controls:

* diabetes
* oral or parenteral steroids treatment
* complicated psychiatric disease
* Warfarins use
A Study to Evaluate the Pharmacokinetic Drug Interaction Between Multiple Doses of JNJ-31001074 and a Single Dose of an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel in Women

The main purpose of this research study is to evaluate the effect of multiple doses of an investigational drug known as JNJ-31001074 on the single dose of combination oral contraceptive Ovral-L containing ethinyl estradiol and levonorgestrel in healthy women who cannot bear children. This study will look at the safety, tolerability (how the drug makes you feel) and pharmacokinetics (what your body does to the drug) of either drug alone and in combination in healthy women.

This is an open-label (both the physician and patient know which treatment will be administered), single center randomized, drug-drug interaction study in healthy female volunteers of non-child bearing potential. A total of 32 volunteers will be enrolled. The study consists of a screening phase, an open label treatment period, and end of study/early withdrawal assessments. Volunteers will be randomly assigned to 1 of 2 treatment sequences. The open-label treatment phase will consist of two periods. In each period, volunteers will receive either of the following treatment(s): Treatment A: a single dose of oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel (Ovral-L) on Day 1 and Treatment B: multiple daily doses of 10 mg JNJ-31001074 on Days 1 to 8 and a single dose of oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel (Ovral-L) on Day 7. A washout (no treatment break or drug holiday) period of 28 days separates the two occasions of single dose administration of oral contraceptives in Periods 1 and 2. Safety and tolerability will be assessed from the time of informed consent to the end-of-study evaluations or early withdrawal. Volunteers will be instructed to report any serious adverse events that occur up to 30 days following the last dose of study drugs. For Treatment A, the volunteer will receive a single dose of oral contraceptive. For Treatment B, the volunteer will receive 10 mg tablet of JNJ-31001074 once daily orally for eight days (Days 1 to 8) and a single dose of oral contraceptive on Day 7.

Eligibility Criteria:
Inclusion Criteria:

* Women of non-child bearing potential (i.e., postmenopausal \[no spontaneous menses for at least 2 years\] or surgically sterile) 18 to 65 years of age, inclusive
* negative pregnancy test
* body mass index between 18 and 30
* body weight greater than or equal to 50 kilograms

Exclusion Criteria:

* History of or current clinically significant medical illness
* abnormal lab values or physical exams
* pregnant or lactating
* used any hormonal products 3 months before study
* drug or alcohol abuse
* history of smoking or nicotine use, 2 weeks before start of study
* clinically significant allergy
* use of prescription and non-prescription medications within 2 weeks before the start of the study
Permissive Hypotension After Cardiac Surgery

The objective of this pilot randomized controlled trial is to demonstrate the feasibility of implementing a pragmatic clinical trial randomizing patients to permissive hypotension versus usual care and to determine the impact of permissive hypotension on vasopressor exposure, ICU length of stay, markers of end organ perfusion, and clinically relevant patient outcomes. The data collected from this pilot study will be used as preliminary data for study design and grant applications for a larger multicenter randomized controlled trial.

The investigators will perform a single center, open-label, randomized controlled trial in patients admitted to the HCICU after cardiac surgery at MGH. Patients who are hypotensive (MAP \< 65mmHg) and/or require vasopressor support to maintain a MAP ≥ 65mmHg during the first 24 hours of ICU admission will be eligible for randomization. Patients will be randomized in 1:1 fashion to either a) Permissive Hypotension (MAP target \>60mmHg) or b) Usual Care. The duration of the intervention will extend until the patient no longer needs vasopressors to maintain prespecified MAP. Outcomes of interest include continuous hemodynamics (both recorded values from EHR as well as the arterial line waveform data), vasopressor exposure (as measured by maximum Vasopressor-Inotrope Score, mean Vasopressor-Inotrope Score, and duration of vasopressor use), lactate clearance, rates of atrial fibrillation, need for renal replacement therapy, ICU length of stay, survival to hospital discharge, cognitive state at discharge using Montreal Cognitive Assessment score. Additionally, the investigators will perform exploratory analyses using the continuous arterial line waveform data to evaluate for potential differences in arterial waveform morphologies between groups to help discern the hemodynamic impacts of permissive hypotension and to potentially identify subphenotypes who may derive greater benefit.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Schedules for elective or non-emergent cardiac surgery

Exclusion Criteria:

* Arrival to the CICU with severe shock determined any of the following: Norepinephrine dose \>20mcg/min, Epinephrine \>3mcg/min, Dobutamine \>2.5mcg/kg/min, Milrinone \>0.2mcg/kg/min
* Rapidly increasing pressors within 60 mins of arrival.
* Significant prior renal dysfunction (CKD \>4), hemodialysis dependence
* Cirrhosis
* A neuropathology diagnosis warranting blood pressure goal
* Pre-specified MAP goal as determined by clinical team
* Carotid stenosis (\> 50%) or prior stroke
* Bleeding requiring return to the OR
* Need for mechanical circulatory support
* Heart and Lung transplantation
* Aortic dissection
Extracellular Vesicles and Particles (EVP) as Biomarkers of Recurrence in Non-Small Cell Lung Cancer

The purpose of this study is to find out if fluid rinsed from peoples' airways (bronchial washing samples) during routine surgery to remove (resect) their non-small cell lung cancer (NSCLC) tumors contains enough vesicles to do testing that may help the researchers learn more about their NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* All patients ≥ 18 years of age undergoing consideration of surgical resection, including lobar resections, sublobar resections, and pneumonectomies, for primary lung cancer will be eligible.
* Patients with previously resected disease and/or previous radiation therapy will be considered on a case by case basis.

Exclusion Criteria:

* Patients with active infection or pneumonia which may impact exosome makeup
* Additionally, if at the discretion of the operating surgeon, obtaining bronchial washings would lead to undue morbidity, the patient would be excluded and replaced
A Study of Carboplatin + Paclitaxel and MK0683 in Patients With Chemotherapy-naive Non-Small Cell Lung Cancer (NSCLC)(0683-066)

The clinical study will evaluate safety, tolerability and Pharmacokinetics of MK0683 in combination with carboplatin and paclitaxel in chemotherapy-naive NSCLC patients.


Eligibility Criteria:
Inclusion Criteria:

* Chemotherapy-naive patients who are histologically or cytologically diagnosed NSCLC with stage IIIB (not applicable of radical thoracic radiation) or stage IV
* Patients with normal organ function and bone marrow function

Exclusion Criteria:

* Given radical thoracic radiation for NSCLC or radiation for other than original lesion within 3 weeks
* Any peripheral neuropathy above grade 2
* Any ascites, pleural effusion or pericardiac effusion which requires treatment
* Any uncontrolled concomitant illness
* Pregnant or breast-feeding
The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hypertension in Patients With Interstitial Lung Disease

Pulmonary hypertension (PH) is a common disorder among patients with interstitial lung disease (ILD). The symptoms are usually nonspecific and overlooked. Thus, a noninvasive screening modality is recommended for early detection of PH because of its potentially significant impact on treatment strategy and clinical outcomes.

Objectives: To evaluate the usefulness of assessing forced vital capacity (FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), and FVC%/DLCO% ratio to predict pulmonary hypertension among patients with ILDs.


Eligibility Criteria:
Inclusion Criteria:

* This retrospective study included all patients diagnosed with interstitial lung disease (ILD) who were followed up by the chest department of a tertiary hospital between September 2016 and January 2017

Exclusion Criteria:

* patients with occupational history
* collagen vascular disease predisposing them to lung disorders
* patients who could not undergo pulmonary function testing
Precise High Resolution MRI to Increase Accuracy and Gain Confidence to Diagnose Patients With Optic Disc Edema

The presence of optic disc swelling at the fundus is a non-specific clinical sign that can occur in many ophthalmologic, neuro-ophthalmologic or encephalic pathologies. The diagnostic range is vast, including inflammatory pathologies of the optic nerve, infiltrative or compressive orbital pathologies, idiopathic or secondary intracranial hypertensions, not to mention the pseudo optic disc swelling found in drüsens.

MRI is increasingly being used as a first-line examination to obtain an etiologic diagnosis in a patient with optic disc swelling. It allows a rapid diagnosis to be made in cases of inflammatory pathology or compressive or infiltrative pathology. It can provide very suggestive elements in the case of intracranial hypertension. It appears to be potentially useful in diagnosing ischemic optic neuropathy or in directing towards an etiological diagnosis of Giant Cell Arteritis.

The development of new high-resolution MRI sequences has made it possible to obtain extremely fine resolutions of a few hundred microns in the plane. Apart from a few clinical cases and small series, there is no precise evaluation of the interest of these new sequences in the positive and etiological diagnosis of ophthalmological, neuro-ophthalmological and encephalic pathologies responsible for the presence of optic disc swelling.

The objective of our study is therefore to evaluate the diagnostic contribution and the gain in diagnostic confidence provided by these new sequences in the context of pathologies manifesting as optic disc swelling.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* presenting a papillary edema detected clinically at the back of the eye
* Express consent to participate in the study
* Affiliate or beneficiary of a Social Security scheme

Exclusion Criteria:

* MRI contraindication (electrical device, metallic foreign body, claustrophobia)
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman
A Trial of Oral BEZ235 and BKM120 in Combination With Paclitaxel With or Without Trastuzumab

The purpose of the trial is to determine the maximum tolerated dose (MTD) of BEZ235 and BKM120 in combination with weekly paclitaxel and weekly paclitaxel/trastuzumab.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with metastatic or locally advanced solid tumors, for whom weekly paclitaxel treatment is indicated (BEZ235-paclitaxel /BKM120-paclitaxel treatment)
* HER2+ metastatic or locally advanced breast cancer patients eligible for weekly paclitaxel and trastuzumab (BEZ235-paclitaxel-trastuzumab /BKM120-paclitaxel-trastuzumab treatment)
* Adult patients (≥ 18 years) (males, females)
* World Health Organization (WHO) performance status ≤ 2
* Adequate bone marrow function:
* Adequate hepatic and renal function:

Exclusion Criteria:

* Patients with primary central nervous system (CNS) tumor or CNS tumor involvement. However, patients with a metastatic CNS lesion may participate in this trial, if the patient is \> 4 weeks from therapy (including radiation and/or surgery) completion, clinically stable with respect to the tumor at the time of study entry, and not receiving enzyme-inducing antiepileptic drugs or corticosteroid therapy or taper, as treatment of the brain metastases
* Patients who have received prior systemic anticancer therapy within the following time frames
* Cyclical chemotherapy: ≤ 3 weeks before study treatment (6 weeks for patients treated with nitrosoureas)
* Biological therapy: ≤ 4 weeks before study treatment, except treatment with trastuzumab (both parts of the trial)
* Investigational drug: ≤ 4 weeks before study treatment
* Patients who have undergone major surgery ≤ 4 weeks before study treatment
* Patients receiving chronic treatment with corticosteroids or other immunosuppressive agents
* Patients with uncontrolled, unmanageable, treatment-refractory diabetes mellitus
* Active or history of major depressive episode, bipolar disorder, obsessive-compulsive disorder, schizophrenia, history of suicide attempt or ideation, or homicide, as judged by the investigator and/or based on recent psychiatric assessment

Other protocol-defined inclusion/exclusion criteria may apply
Exercise Programs on Gait in Children JIA

Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. All these situations can lead to postural imbalance and asymmetrical loading pattern, which we often encounter in children with JIA. Current studies describing various exercise methods effective on postural alignment. However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children JIA.

Juvenile Idiopathic Arthritis (JIA) is one of the common chronic diseases in childhood. Problems such as weakness or pain may occur in JIA, especially in the joints and the muscles around the trunk. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. These conditions may lead to abnormal displacement of the center of gravity, deterioration of biomechanics, and muscle imbalance in children with JIA. All these situations can lead to postural imbalance and asymmetrical loading pattern, which we often encounter in children with JIA. Current studies describing various exercise methods effective on postural alignment. However, no study was found in the literature that searching the effects of these exercise methods on gait parameters in children JIA. Therefore, this study aimed to investigate the effects of two different exercise programs (core based exercise program against neuromuscular training) on gait parameters in children JIA.

In this study, the participants will be evaluated and then they will be divided into two groups randomly. The first group will be administered as a core based exercise program group and the second one will be undergone as a neuromuscular training group. After the interventions, they will be re-evaluted by the physiotherapist and the outcomes will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of oligoarticular JIA
* Being between the age of 8 and 16
* Having included knee joint.

Exclusion Criteria:

* Having an additional neurological or orthopedic diagnosis other than JIA Affecting treatment results,
* Having had any surgery on the spine or the extremity joints
* Being at a level that will not understand the questions asked.
Thiol/Disulphide Homeostasis and Albumin in Vertigo

Vertigo is a common complaint in the Emergency Department (ED). The differential diagnosis of central and peripheral vertigo is a difficult issue that directly affects mortality. Magnetic resonance imaging (MRI) is the preferred diagnostic tool, but may not be suitable in all patients due to logistic and economic conditions. In this study, the investigators evaluated the role of thiol/disulfide homeostasis (TDH) parameters and ischemia modified albumin (IMA) levels to assist in the value of being used instead of MRI.

The study was conducted in the ED using a prospective, non-randomized method, and included patients with complaints of acute onset vertigo over 18 years of age and who underwent brain MRI. Pregnant women, smokers, and those with significant neurological signs were excluded. Patients with acute ischemia with MRI were included in the central vertigo group, and patients with normal MRI were included in the peripheral vertigo group. Blood samples for native thiol (NT), total thiol (TT), disulfide, and IMA were collected from all patients at admission. Statistical analyzes were performed with IBM SPSS Statistics for Windows 16.0 Package Program.

Eligibility Criteria:
Inclusion Criteria:

* Patients with complaint of vertigo
* Patients over18 years of age

Exclusion Criteria:

* Patients contraindicated for MRI due to metal prosthesis or claustrophobia
* Patients under 18 years of age
* Pregnant patients
* Tobacco users
* Patients exhibiting significant neurological signs or symptoms such as motor or sensory neurologic deficit, speech disorders, unconsciousness, or seizure
* Patients found to have any type of lesion such as a hematoma, mass, cyst, aneurysm, arteriovenous malformation, etc. other than ischemic infarcts on MRI
* Patients with an ischemic lesion other than posterior fossa lesions
* Patients with any type of infection, including upper respiratory tract and ear infections
* Patients previously diagnosed with peripheral vertigo
* Patients where the cause of lightheadedness was blood pressure disorders, cardiac ischemic and arrhythmic disorders, thromboembolic diseases, metabolic disorders, trauma, etc. rather than central and peripheral vertigo.
Effects of Lacosamide on Human Motor Cortex Excitability: a Transcranial Magnetic Stimulation Study

This study has been designed to explore dose-depended effects of lacosamide (LCM) on motor cortex excitability with TMS in a randomized, double-blind, placebo-controlled crossover trial in young healthy human subjects, and to compare the pattern of excitability changes induced by LCM with those of carbamazepine (CBZ). LCM selectively enhances slow inactivation of voltage-gated sodium channel, and, in contrast to CBZ, does not affect steady-state fast inactivation (Errington et al., 2006). The enhancement of slow inactivation of sodium channels by LCM is a novel manner to modulate sodium channels and leads to normalization of activation thresholds and a reduced pathophysiological hyper-responsiveness, thereby effectively controlling neuronal hyperexcitability without affecting physiological activity (Beyreuther et al., 2007). Therefore, it is thought that LCM, compared to CBZ, will be better tolerated in clinical settings while being as or even more effective in controlling seizure activity. On the basis of the results from nonhuman studies, it is hypothesized that the TMS profile of LCM will be distinguishable from that of CBZ. CBZ, like other 'classical' sodium channel blockers such as phenytoin, predominantly demonstrated elevated TMS motor thresholds indicating reduced neuronal membrane excitability, without developing significant changes of synaptic intracortical inhibition and facilitation (Ziemann et al., 1996; Chen et al., 1997; Lee et al., 2005). Because of its novel mode of action it can only be speculated which TMS parameters LCM might affect. For example, more than exclusively affecting neuronal membrane excitability, LCM could possibly also affect inhibitory mechanisms such as short- and long-latency intracortical inhibition (Valls-Sole et al., 1992; Kujirai et al., 1993). This would in line with other well-tolerated modern antiepileptic drugs (Ziemann et al., 1996; Reis et al., 2002; Lang et al., 2006).


Eligibility Criteria:
Inclusion Criteria:

* healthy
* male
* right-handed
* aged 18-45 years

Exclusion Criteria:

* cardiac pacemaker
* metal implants in the head
* intake of any medication
* previous neurologic, psychiatric, or chronic internal diseases
* pregnancy or breastfeeding; drug, nicotine, or alcohol abuse
* known or expected intolerance to soy beans, peanuts, LCM or CBZ; abnormal ECG with prolonged PQ-interval
* participation in another clinical trial within the previous 8 weeks