cyrilzakka/clinical-trials huggingface dataset:
Visio-conference for Pre-hospital Triage of Stroke Suspicions

Interventionnal Study to investigate the accuracy of our clinical based algorithm performed by using a visioconference device to assess the eligibility of acute recanalisation treatment (intraveinous thrombolysis (IVT) and/or mechanical thrombectomie (TM). Clinical identification of type of treatment is needed is pre-hospital triage of these patients.

The outcome of ischemic stroke (IS) with large artery occlusion (LVO) is related to the volume of infarcted brain witch is related to the delay of arterial recanalisation. IVT is available in multiple stroke units in France but, in case of LVO, the association with TM is needed. The availability of endovascular capable centers is limited to tertiary care hospitals. As a result, pre-hospital identification of these patients is a priority and the optimization of the triage can be done by a clinical algorithm carried out by a neurological tele-evaluation.

OPTIC-AVC is a multi-phase study. This phase is about the evaluation of accuracy of our algorithm performed by a quick and standardized neurological tele-evaluation to predict the eligibility for recanalisation treatment (IVT and/or TM) of patients suspected of acute stroke in the emergency setting. The effective therapeutic decision for each patient, performed by another neurologist, will be blind to the theoretical therapeutic decision resulting from the algorithm.

Theoretical and effective therapeutic decision will be compared a posteriori

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Suspicion of acute symptomatic stroke whose first symptoms are less than 24 hours old
* Free Consent, informed writing signed by the participant or the person of confidence and the investigator (no later than the day of inclusion and before any examination required by research)

Exclusion Criteria:

* Stupor or coma requiring orotracheal intubation
* Rankin pre stroke \> 4
* Severe cognitive impairement
* Contraindication to the realiszation of angiographic imaging
* Participation refusal
* Patient under legal protection
Cocoa Extract-enriched Meals and Cardiovascular Risk in Older Population

Obesity prevalence in elderly populations has increased in the last years, and the reduction of overweight and obesity is a priority target in populations of all age ranges worldwide. Obesity is a disease frequently accompanied by a pro-inflammatory state, in which metabolic functions may be compromised, and therefore there is a risk of developing comorbidities such as type-2 diabetes, hyperlipidemias, hypertension, atherosclerosis, etc. In this context, plant extracts are a good source of antioxidant compounds. Among these compounds, polyphenols have been shown to have an important antioxidant effect. Scientific evidence based on epidemiological studies suggest that flavonoids from the diet play an important role on the prevention of cardiovascular disease. Cocoa and related products are an important source of flavonoids, providing even more than tea or wine. Generally, benefits associated to cocoa consumption are related to the ability for improving lipid profile and insulin sensitivity, reducing blood pressure, platelet activity and improving endothelial dysfunction. Some studies have also shown an improvement of inflammatory conditions, mainly due to the capacity of the polyphenols contained to modify cellular transcription, and the secretion of proinflammatory cytokines in peripheral blood mononuclear cells, macrophages and lymphocytic strains. Therefore, the hypothesis of this study is that the consumption of cocoa extract-enriched prepared meals, within a hypocaloric diet, will help to reduce body weight and to improve cardiovascular risk factors compared to the same diet with standard prepared meals.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index between 27 and 35.5 kg/m2
* Subjects with central adiposity (waist circumference over 94 cm in males and 80 cm in females)
* Subjects presenting insulin resistance non pharmacologically treated
* Subjects presenting hyperlipidemia non pharmacologically treated

Exclusion Criteria:

* Subjects following dietotherapy to loose weight at the moment of the study or in the past three months.
* Subjects with variations of weight greater than 5% of their body weight in the last three months).
* Subjects with deficient nutritional or hydration status.
* Subjects suffering from chronic diseases such as cancer, diabetes, hyperlipidemia, etc.
* Subjects with functional or structural impairments in digestive tract (peptic ulcer, malabsorption syndrome, inflammatory state, etc.)
* Subjects having gone under digestive surgery and have permanent consequences.
* Subjects suffering from allergy to cocoa or derived products.
* Subjects being physically or psychologically affected, with difficulties to attend the facilities with the required frequency.
* Smokers and frequent (more than 3 portions of beer/wine/spirits per day in males and 2 portions of beer/wine/spirits per day in females)
Can Vignettes Be Used to Improve Practice & Outcome

This is a pilot study to first measure the cross-sectional relationship between variations in physicians� vignette scores and aggregated scores of individual physicians� patient health outcomes; and second to (longitudinally) determine whether feedback of vignette scores improves physicians� clinical performance as measured by vignettes

1. Study Design: Physicians will complete computerized vignettes for four conditions � diabetes, coronary artery diseases (CAD), chronic obstructive pulmonary disease (COPD), and depression. We will collect retrospective outcomes data and develop composite outcome measures for on two conditions, Diabetes and CAD. For the longitudinal analysis, only vignette data will be collected and fed back to providers. Feedback will consist of specific data on vignette outcome scores for the individual physicians and for the sites overall.
2. Site Selection: Primary care clinics at 2 VAMCs
3. Study Population and Sampling: We will enroll primary care physicians at 2 VAMCs. 30 consenting physicians will be prospectively randomized into two groups. One group will receive feedback of their vignette scores, and the other group will serve as control, receiving no feedback.
4. Variables and Measurement Instruments: Computerized vignettes measuring clinical practice completed by the physicians for diabetes, CAD, COPD, and Depression and a composite health outcome measures from the medical records of these physicians� patients with diabetes and CAD.
5. Data Collection Strategy and Timeline: Vignettes will be administered to all physicians at baseline, with feedback of scores 3 months later and readministration of vignettes 9 months thereafter to measure the trend in improvement. The composite outcome data will only be collected at baseline only.
6. Data Analysis: The statistical analysis will compare the effects within the context of an analysis of covariance (ANCOVA) model. The analyte is the quality of care physicians give to patients with four common conditions. The relationship between vignette scores and patient outcomes will be modeled accounting for clustering effects. The prospective experimental design will be used to quantify possible differences between the intervention and control groups. The data will be analyzed using a three-way crossed, one-way nested ANCOVA model where the covariate is the baseline vignette score. This model can be used to look at case effects, by domain, level of training, and by site.

Eligibility Criteria:
Inclusion Criteria:

Physician at SF VAMC with panel of primary care patients

Exclusion Criteria:

None
Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.

Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181037 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.

Eligibility Criteria:
Inclusion Criteria:

* renal cell carcinoma that is not amendable to standard therapy with curative intent

Exclusion Criteria:

* current treatment in another therapeutic clinical trial
SHMT1 Polymorphism in Parkinson's Disease,

Parkinson Disease (PD) is the most common movement disorder and represents the second most common degenerative disease of the central nervous system . SHMT has been shown to be associated with various diseases.

This case -control observational prospective study will conducted on 40 patients with PD.

Eligibility Criteria:
Inclusion Criteria:

* Patients age ≥ 50 years.
* Patients with PD diagnosed according to the United Kingdom Parkinson's Disease Society Brain Bank (UK PDS Brain Bank diagnostic criteria)

Exclusion Criteria:

* Patients with parkinsonian plus syndrome

  * Patients with secondary parkinsonism
  * Patients with other chronic comorbidities (renal, hepatic, and endocrinal disturbances and chronic chest disease.)
  * Past and /or present history of epilepsy.
  * Patients with disturbed conscious level.
Safety, Tolerability and Pharmacokinetics of Single Rising Intravenous Doses of BI 44370 BS Solution in Healthy Male Volunteers

Study to investigate safety, tolerability, and pharmacokinetics of BI 44370 BS solution for intravenous (i.v.) infusion


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs (Blood Pressure (BP), Pulse Rate (PR), Respiratory Rate (RR) and body temperature), 12-lead ECG, clinical laboratory tests
* Age 21 to 50 years inclusive
* Body Mass Index (BMI) 18.5 to 29.9 kg/m2 inclusive
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and German law

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR, RR, body temperature and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
* A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
* Not willing to use adequate contraception (condom use plus another form of contraception, e.g. spermicide, oral contraceptive taken by female partner, sterilisation, or intrauterine device) during the whole study period from the time of the first intake of study drug until three months after the last intake
Detection of Borrelia Bacteria in Early Stage Lyme Borreliosis Using the T2Lyme Panel

The T2Lyme assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease.

The objective of this study is to demonstrate the clinical performance of the T2Lyme Panel on the T2Dx instrument. The assay will be compared to Borrelia culture from erythema migrans (EM) biopsy and/or detection of the C6 antigen in serum collected prospectively from patients suspected of early Lyme disease. The data from this study will be used to support a de novo application for the T2Lyme Panel to the U.S. Food and Drug Administration (FDA) for product approval.

The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Presence of erythematous skin lesion, consistent with erythema migrans (EM).
* Age 18 or older.
* Ability to read, comprehend, and sign the informed consent form.
* Two (2) or more signs/symptoms of Lyme Disease

Exclusion Criteria:

* Subject has medically diagnosed bleeding disorder.
* Having had taken antibiotics in the past 30 days.
* EM located on face or neck.
* Unable to provide consent.
Comparison of Insulin Aspart Produced by the NN2000 Process to the Current Process in Type 1 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the safety and efficacy of insulin aspart produced by current process compared to that of insulin aspart produced by NN2000 process in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 1 diabetes
* Duration of diabetes for at least 12 months
* Treatment with insulin aspart for at least 3 months before trial start
* Body Mass Index (BMI) below 35.0 kg/m2
* HbA1c below 12.0%

Exclusion Criteria:

* Total insulin dosage more than 1.4 IU/kg/day
* Recurrent major hypoglycaemia that may interfere with trial participation (as judged by the investigator)
* Known hypoglycaemia unawareness as judged by the investigator
* Known hypersensitivity or allergy
Personalized Non-invasive Neuromodulation by rTMS for Chronic and Treatment Resistant Catatonia

Investigators hypothesize that personalizing rTMS targets using functional MRI will allow to improve symptoms of patients suffering from chronic catatonia.

Two dysfunctional networks or regions will be chosen (verum 1 and 2) based on their abnormal rCBF. In line with the symptoms, dorso-lateral prefrontal and premotor regions are expected to be chiefly concerned. A normal region regarding its rCBF will be used as placebo. Targets will be stimulated using intermittent or continuous theta-burst according to the rCBF anomaly as an attempt to "normalize" their activity. The coil will be positioned using a robotic device under the control of a neuronavigation system in order to deliver a homogeneous stimulation. Using a balanced blinded randomized cross-over design, patients will be stimulated on 5 consecutive days (4 sessions per day) and evaluated pre-, post-stimulation and 1 month after. In this pilot study the primary outcome measures will be the clinical global impression scale whereas MRI will insure that stimulations achieved the correction of the rCBF anomalies. Secondary outcome measures will include personalized target symptom scales, and scales for catatonic, apathic and obsessive-compulsive symptoms.

Eligibility Criteria:
Inclusion criteria:

* Aged from 18 to 70 Y
* Affiliated to the health insurance
* Having signed an informed consent
* Suffering from catatonia according to the DSM5, unremitted since \> 2Y
* Unresponsive or incomplete remission after at least one trial of benzodiazepine and/or Electroconvulsivotherapy
* Treatment stable for \> 6 weeks

Exclusion criteria:

* Contraindication for MRI, rTMS or tDCS: non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump clip or vascular stent, heart valve or ventricular shunt, seizure disorders, skin pathology in the region of tDCS electrode placement.
* Pregnancy
* Severe and non-stabilized somatic pathology
* Patients deprived of liberty or hospitalized without their consent
* Patients unable to give informed consent.
Effect of Meal Replacement Beverage(Glucerna) on Body Composition,Lipid Metabolism and Blood Pressure

Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and blood pressure

The Effect of Meal Replacement Beverage(Glucerna) on Body Composition,lipid metabolism and blood pressure in Patients with Obesity

Eligibility Criteria:
Inclusion Criteria:

1. age：14\~60years
2. BMI ≥ 28kg/m2
3. without liver, kidney, gastrointestinal and other major organic serious diseases,lactating women, pregnancy
Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication

The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.


Eligibility Criteria:
Inclusion Criteria:

* Age at the time of enrollment: Adults 18 and older
* Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
* Fluent in English
* Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
* Lives in the United States

Exclusion Criteria:

* Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies.
* Any current drug or alcohol abuse.
* Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
* Pregnancy, breast-feeding or wanting to become pregnant.
* Patient is unable to communicate properly with staff (i.e., severe speech problems).
* Excessive drooling
Neural Respiratory Drive of Patients With Chronic Obstructive Pulmonary Disease

To investigate the relationship among the neural respiratory drive (NRD), the sensation of the dyspnea and the effect of the bronchodilator on each stage COPD patients.

Different stage COPD subjects were recruited. Administration of bronchodilators was prohibited 24 hours prior to the experiment. After the application of topical anesthesia (10% xylocaine) the subject was asked to swallow the multipair esophageal electrode catheter through the nose into their right position. At the first period, the stable signals of spontaneous breathing (about 10 minutes) were collected as the baseline data. At the second period, each subject inhaled compound ipratropium bromide solution (3mg salbutamol and 500μg ipratropium, Boehringer Ingelheim Limited, Germany). A multi-pair esophageal electrode catheter with 10 coils that provided five pairs of electrodes was used to obtain the NRD signals. All NRD signals the were recorded before and after the compound ipratropium bromide solution was inhaled (about 10 minutes). The subjects scored their comfort sensation with a visual analog scale (VAS) ranging from 0 (best) to 10 (worst) at each period.

Eligibility Criteria:
Inclusion Criteria:

The diagnosis of COPD was made according to the global initiative for chronic obstructive lung disease (GOLD) guideline.

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Exclusion Criteria:

(1) Malignancy （2）Severe cardiovascular diseases （3）Neuromuscular and chest wall deformity (4) Cardiovascular instability (hypotension, arrhythmias, myocardial infarction) (5) Change in mental status; uncooperative patients (6) Extreme obesity （7）renal failure and severe blood electrolyte disturbances (8) Asthma-
Effects of Aminophylline Bolus on TCI (Target Controlled Infusion) Concentrations at Return of Responsiveness

Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.

We aimed to compare its effect during a total Intravenous Anaesthesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital.

Aminophylline is an intravenous drug commonly utilized for asthma. However, some preclinical studies and few case reports and case series have described its utility in decrease the timing of return of consciousness after Propofol anaesthesia with an intravenous bolus of 4 mg/kg.

We aimed to compare its effect during a total Intravenous Anasethesia with Target Controlled Infusion (TIVA-TCI) routinely utilized for general anaesthesia in our hospital (with Eleveld or Schnider Pharmacokinetic/Pharmacodynamic-PK/PD model).

The timing from stop of propofol infusion to eye opening and return of responsiveness, the relative Concentration of Propofol (CeP) and the power spectrum of the Bispectral Index (BIS) with or without aminophylline bolus were taken into account.

Eligibility Criteria:
Inclusion Criteria:

* Undergo general anaesthesia with Targeted Controlled Infusion of Propofol (Eleveld or Schnider model) and Remifentanil (Minto model)

Exclusion Criteria:

* Neurological disease
* Psychiatric disease
* Obesity
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The HERMES Study (BY217/M2-125)

The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).


Eligibility Criteria:
Main Inclusion Criteria:

* COPD patients having at least one exacerbation within last year
* FEV1/FVC ratio (post-bronchodilator) ≤ 70%
* FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

* COPD exacerbation not resolved at first baseline visit
* Diagnosis of asthma and/or other relevant lung disease