cyrilzakka/clinical-trials huggingface dataset:
Detecting Lung Infections Through Vibration

The purpose of this study is to test a lung air vibrator device for vibrating air inside the lung. This exploratory diagnostic trial will test a novel and non-invasive means of detecting lower airway infections using exhaled breath sample.

This study has two phases. Once the subject has consented phase 1 will start by the subject breathing air out of their lungs into the device. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air.

In phase 2, the subjects will breathe air out of their lungs into the device for 15 minutes. Next, the subject will simply breathe through the mouthpiece with the machine turned on and take samples of exhaled air for 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-50

Exclusion Criteria:

* History of major respiratory compromise (except cystic fibrosis if included within cystic fibrosis cohort)
A Phase 2 Study of Radiprodil in Subjects With Drug-resistant Infantile Spasms (IS)

The purpose of the study is to evaluate the safety and tolerability, the pharmacokinetics and the efficacy of radiprodil in abolishing clinical spasms in subjects with drug-resistant infantile spasms

The study is divided into 3 parts:

Part A - exploratory, Part B - confirmatory, Part C - open label extension

Eligibility Criteria:
Inclusion Criteria:

Part A and B:

* Subject is male or female between 2 and 14 months of age
* The diagnosis of infantile spasms (IS)
* Subject has drug-resistant IS

Part C:

* Subject participated in EP0078 Part A and received 2 radiprodil treatment cycles
* Subject experienced a relapse of spasms during the down taper or within 5 half-lives (3 days) discontinuation of radiprodil treatment in Cycle 2 of Part A
* Electroencephalogram (EEG) on baseline Part C is compatible with the diagnosis of infantile spasms

Exclusion Criteria:

Part A and B:

* More than 6 months have passed since the diagnosis of Infantile Spasms (IS)
* Current treatment with cannabinoids
* Subject has hematocrit greater than 60
* Subject has any medical condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject's ability to participate in this study
* Subject has a history or current condition predisposing to respiratory dysfunction
* Current treatment with felbamate
* Current treatment with perampanel
* Ketogenic diet
* Clinically significant lab abnormalities
* Clinically significant abnormality on ECG that, in the opinion of the Investigator, increases the safety risks of participating in the study
* Subject has a lethal or potentially lethal condition other than IS, with a significant risk of death before 18 months of age such as non-ketotic hyperglycinemia
* Body weight is below 4 kg
* Known history of severe anaphylactic reaction secondary to medication intake or serious blood dyscrasias

Part C:

* Subject experienced any acute tolerability issues in either treatment cycle in Part A which the investigator and the sponsor medical monitor consider a risk for further participation
* Subject met any withdrawal criteria in Part A
* Subject has experienced any adverse effects or developed any new medical conditions since enrollment in Part A which the investigator considers could significantly increase the safety risks of participating in Part C
US & HILT Comparative Effect on Neuropathic Pain, Strength & QOF in Diabetic Foot

To compare the effects of therapeutic ultrasound and high intensity laser therapy on neuropathic pain , strength and quality of life in patients with diabetic foot

therapeutic ultrasound and laser therapy with routine physical therapy are used to improve neuropathic pain and foot related quality of life. the scarcity of evidence regarding the application of high intensity laser therapy necessitates a comprehensive investigation. The effects of HILT and comparative effects with ultrasound remains largely unexplored in diabetic peripheral neuropathy

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes.
* Diabetic Patients of age 50 to 75 years.
* Diabetic patient of Both genders
* Diagnosed Diabetes Mellitus with at least 7 years of duration
* Distal symmetrical or asymmetrical polyneuropathy with pain in the lower extremity for ≥6 months
* DNS (Diabetic neuropathy symptoms questionnaire) score greater than 4 (90 percent probability of neuropath

Exclusion Criteria:

* Pregnant females
* Lower limb Amputated patients
* History or evidence of neurological disorders other than peripheral neuropathy associated with Diabetes mellitus.

  * Evidence of musculoskeletal dysfunctions like scoliosis, lumbar disc prolapses and lumbar spine associated radiculopathy.
  * History of any low back surgeries and lower limb surgeries
* Patient with malignancy. Patient with epilepsy
* Patient with hemophilia
* Patient with pacemaker, metal implants prosthesis and internal fixation screws.
* Patient with severe cervical and lumbar neuropathy, rheumatoid arthritis, hereditary neuropathy
* Patient with a history of neurosurgery
Representational Approach to Hippocampal Functions : a fMRI Study

Although traditional neuropsychological models associate medial temporal lobe (MTL) regions to memory, and the hippocampus to episodic memory, there is growing evidence supporting an alternative view. The representational view of the MTL proposes that such regions depends on the representations processed rather than the cognitive processes. The aim of this project is to characterise the role played by MTL areas, and particularly the hippocampus, in mnemonic and non-mnemonic cognition. Hypotheses stemming from the representational view will thus be tested, using functional MRI among young healthy participants.

Traditional neuropsychological models associate the medial temporal lobe (MTL) with episodic memory. Further, the hippocampus would be responsible for recollection, or the rich and contextualised retrieval of a memory; whereas the perirhinal cortex (PRC) would process familiarity, or the feeling that a stimulus has been encountered before, without remembering where or when it happened. However, there is growing evidence questioning this view, and supporting an alternative proposal. The representational view of the MTL proposes that such regions would not be organised according to cognitive processes, but rather according to the representations (or the mnemonic content, represented by a pattern of neuronal spikes. A 2018-fMRI study demonstrated that the engagement of the hippocampus in recollection depends on the presence of a spatial scene in the memory that is retrieved, and not on the reconstructive nature of the retrieval. However, this demonstration is incomplete, as the only process that was investigated is recollection. The current project aims to extend such results to memory processes such as familiarity, and even to non-mnemonic processes such as visual discrimination. A fMRI study will thus be conducted, where 30 healthy participants will first perform a visual-discrimination task on scenes and objects, before taking a recognition task, in which images will either be presented in full or in the form of circular cues only. Multivariate-Pattern Analyses (MVPA) will complete traditional fMRI analyses, in order to determine whether activity in the MTL can be categorised on the basis of representations through a machine-learning classifier.

Eligibility Criteria:
Inclusion Criteria:

* Affiliation to French Healthcare system
* No contraindication to MRI examination
* Age between 18 and 35 years-old
* Visual acuity permitting normal perception of stimuli or corrected sight

Exclusion Criteria:

* Existence of a pathology incompatible with the protocol : Heart, respiratory, haematological, caner, neurological disorder...
* Brain-modulating medical treatment
* Alcohol intake before examination
* Uncorrected visual disorder
* Cognitive deficit (criterion MMSE \< 27)
* People protected by articles L1121-5 to L1121-8 of the CSP (pregnant women, under-18 subjects, people under judiciary or administrative surveillance)
The SAFE Prospective Registry

Secretoneurin (SN) is a neuropeptide from the chromogranin family that influences intracellular calcium handling. SN suppresses calcium leakage from the sarcoplasmic reticulum through the ryanodine receptor. SN is a novel biomarker that has shown the potential to predict adverse arrhythmic events.

The aim of the study is to sample SN before and after catheter ablation (CA) for atrial fibrillation (Afib) to predict the recurrence after CA. Also, the uric acid/albumin ratio will be assessed as a marker of Afib recurrence. Since the uric acid/albumin ratio has been shown to be predictive of Afib in patients with myocardial infarction moreover incidence of atrial fibrillation is higher in patients with gout. As a side branch marker for silent brain injury, neuron-specific enolase (NSE) and protein S100B will be evaluated. NSE showed in small trials a significant increase after catheter ablation, as well as S100B. The prognostic power is not clear yet. From the systematic review, the most powerful predictors seem to be N-terminal (NT)-prohormone B-type natriuretic peptide (NT-Pro-BNP/BNP), high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and Carboxy-terminal telopeptide of collagen type I. Biomarkers are divided into 3 main types: congestion, inflammation, and renal function.

Patients will be enrolled before catheter ablation/electrical cardioversion for Afib after signing IS, and the blood sampling will be performed the day before and the day after catheter ablation. In the electric cardioversion arm, the blood sampling will be performed before electrical cardioversion and 2h after the cardioversion before discharge.

Patients will be followed for recurrency - all patients will have a 24-hour ECG Holter and External loop recorder (MDT) for two weeks after the three months of the blanking period. Clinical outpatient control will ensue in the 4th, eighth,12, and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Atrial fibrillation (Afib); (paroxysmal, persistent)
* Patients indicated for catheter ablation and/or electrical cardioversion
* Signed informed consent

Exclusion Criteria:

* Longstanding or permanent atrial fibrillation
* Severe mitral regurgitation
* Heart failure with a permanently reduced ejection fraction
* Cerebral ischaemic stroke in \< 3 months
* Severe kidney injury
* Severe renal insufficiency
* Hepatic insufficiency limiting biomarker sampling
* Myocardial infarction \< 3 months
Nutritional Study of Fish Oil in Skin Quality in Healthy Women

The skin acts as a barrier against the external environment and prevents water loss from the body. Aging is a natural process leading to changes in the skin and fish oil has been shown to prevent inflammation, hyperpigmentation and UV-damage. This pilot study will determine skin characteristics after intervention with north atlantic fish oil.

Women will be recruited to a placebo or fish oil group and be examined at pre- and post for skin quality parameters such as wrinkles, fine lines and trans-epithelial water loss.

Eligibility Criteria:
Inclusion Criteria:

Healthy women in the age of 30-65

Able to follow the following dietary restriction for 4 months (4 weeks wash-out, 3 months intervention):

* Do not take omega-3 supplements
* do not take supplements containing vitamin A
* do not take supplements containing collagen
* try to avoid using skin products containing vitamin A
* do not undergo skin treatment

Exclusion Criteria:

Pregnancy or breast feeding known allergy to seafood skin treatment the last 6 months planned skin treatment during the study period

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The Effect of Facial Exercise on the Appearance of Aging

This study seeks to evaluate the effects of facial exercises on aging of the face.


Eligibility Criteria:
Inclusion Criteria:

* Aged 40-65 years
* No significant medical illness
* No chronic smokers
* Subject with mild to moderate facial atrophy
* Subjects who provide and interest and who understand the importance of consistently executing the program daily.
* Subjects with the willingness and ability to understand and provide informed consent.

Exclusion Criteria:

* Under 40 years of age, Over 65 years of age
* Pregnant or lactating
* Subjects who have ever had any invasive cosmetic procedure, including facelifts, neck lifts, laser resurfacing, dermabrasion, or liposuction
* Subjects who have non-invasive or minimally invasive cosmetic procedures, such a non-ablative lasers, medium-depth or deeper chemical peels, injectable neurotoxins or fillers, within the past year.
* Subjects who have used topical or oral retinoids within the past year.
One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction

The objective of this study is to evaluate the safety and effectiveness of the enVista® One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens has been removed by an extracapsular cataract extraction method (eg, small incision phacoemulsification).


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinically documented diagnosis of age-related cataract that is considered amenable to treatment with standard phacoemulsification/extracapsular cataract extraction.
* Subjects must have a best corrected visual acuity (BCVA) equal to or worse than 20/40 in the study eye, with or without a glare source.
* Subjects must have a BCVA projected to be better than 20/30 after IOL implantation in the study eye.

Exclusion Criteria:

* Subjects with any anterior segment pathology for which extracapsular phacoemulsification cataract surgery would be contraindicated.
* Subjects with any other serious ocular pathology, or underlying serious medical conditions, which based on the Investigator's medical judgment, could confound the results of the study.
Transcranial Direct Current Stimulation and Antisocial Behavior

The main objective of this study is to investigate the causal relationship between prefrontal cortex activity and antisocial behavior, as well as risk factors for antisocial behavior. Specifically, this study tests the hypothesis that upregulating activity in the prefrontal cortex through a non-invasive form of brain stimulation, transcranial direct current stimulation (tDCS) will reduce antisocial and aggressive behavior. The effects of 3 days of anodal stimulation over the prefrontal cortex are assessed.


Eligibility Criteria:
Inclusion Criteria:

* Above 18 (with parental consent) or above 21 (without parental consent)
* Able to understand the nature of the study and give informed consent

Exclusion Criteria:

* History of or active neurologic, cardiovascular, or psychiatric disease including anxiety disorders (e.g., PTSD, panic attacks, obsessive-compulsive disorder) and mood disorders (e.g., depression)
* Currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications
* Currently consuming anti-depressants
* History of seizures
* Metallic implants on scalp
* Participated in any other non-invasive brain stimulation study in the same day
* Ever had an adverse reaction to tDCS
Post-market Clinical Follow-up of Pfmmedical Ports

Prospective, monocentric, non-randomised, observational post-market clinical follow-up study in Germany to obtain post-market information on the pfmmedical ports with a follow-up (FU) of 6 months. The focus is on patient reported satisfaction, clinical application, and complication rates.


Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years.
* Medical indication for port catheter implantation.
* The patient is mentally able to understand the nature, aims and possible consequences of the PMCF study.
* Patient information has been provided and written consent exists.

Exclusion Criteria:

* Contraindications according to the manufacturer´s instructions for use (IFU).
* The patient is institutionalised by court or official order (MPDG §27).
* Patient participates in another operative clinical investigation if it relates to the area of port devices and/or influences the primary endpoint of the PMCF study.
* Patients who currently already have a port implanted.
Atypical Orofacial Pain Diagnostics and Differentiation.

Orofacial pain is diagnosed for more than 1.9 percent of general population and for 0.3 percent origin of the facial pain is unknown. Commonly atypical facial pain is treated as a neurological condition without an emotional or psychiatric evaluation. Since atypical pain and mood affective disorders can be related, patients do not receive proper care for this condition.

The aim of this study is to evaluate the relationship between atypical facial pain syndrome and affective mood disorders. We aim to assess patients' with no diagnosed organic pathology tendency towards anxiety, depression, sleep disorders and one of big five personality traits through self-rating questionnaires. We will compare the gathered data with biosensors from iMotions software.


Eligibility Criteria:
Experimental group The experimental group will consist only of adult patients (18-70years old), who were clinically diagnosed with atypical pain syndrome (G50.1) after all diagnostic measures were performed.

Inclusion criteria:

* Adult patients (18-70years old) who were clinically diagnosed with atypical pain syndrome (G50.1).
* Patients who accepted terms of this research and has signed informed consent form.
* Patients were not previously diagnosed with a psychiatric disorder.

Exclusion criteria:

* A potential participant of the study is not able to comprehend information regarding this study's protocol in both written and verbal forms or fails/refuses to sign an informed consent form.
* Patients who have a diagnosed organic pathology causing orofacial pain.
* Patients who are diagnosed with systemic diseases which may interfere with the study or patients who present with head or neck oncology pathologies.
* Patients who were previously diagnosed with a psychiatric disorder.

Control group Control group will consist of patients who were subjected to maxillofacial fracture (any jaw unilateral fracture). These patients will be involved in this study if they are hospitalized/or have visited Lithuanian University of Health Sciences hospital Kaunas Clinics Department of maxillofacial surgery.

Inclusion criteria:

* Adult patients (18-70year old) who have been diagnosed with orofacial pain due to jaw fracture (S02.3, S02.4, S02.6).
* Patients who have signed an informed consent form.
* Patients who were not previously diagnosed with a psychiatric disorder.

Exclusion criteria:

* A potential participant of the study is not able to comprehend information regarding this study's protocol in both written and verbal forms or fails/refuses to sign an informed consent form.
* Patients who are diagnosed with systemic diseases which may interfere with the study or patients who present with head or neck oncology pathologies.
* Patients who were previously diagnosed with a psychiatric disorder.
Development of Human Laboratory Study Model of Cocaine Relapse Prevention II - 1

To study of classical conditioning mechanisms associated with arousal, craving and cocaine use.

This is a single-site, double-blind, placebo-controlled crossover study of classical conditioning mechanisms associated with arousal, craving and cocaine use.

Eligibility Criteria:
Inclusion Criteria:

* Be English-speaking volunteers who are cocaine dependent
* Be non-treatment seeking at the time of the study
* Meet DSM-IV criteria for cocaine dependence
* Have ECG showing normal sinus rhythm, normal conductivity, and non clinically significant arrhythmias
* Females must provide a negative pregnancy test and agree to use birth control
* Have baseline laboratory tests within normal limits

Exclusion Criteria:

* Please contact site for more information
Prospective Evaluation of Treatment for Clubfoot

Specific aim:

To evaluate the outcome of infants who undergo one of two nonsurgical treatment interventions

PURPOSE: The purpose of this project is to help orthopaedic surgeons better understand and treat patients with a diagnosis of clubfoot. This proposed research will establish a protocol for the collection of relevant clinical and functional outcome measures on our patients with a diagnosis of clubfoot.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of clubfoot deformity
* Spanish speaking patients will be eligible to participate in the study.

Exclusion Criteria:

* All patients without a diagnosis of clubfoot
Cilostazol and Aspirin in Stroke and TIA

This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin or to clopidogrel plus aspirin. The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis.

This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin (aspirin 100mg with cilostazol 200 mg for 21 days) or to clopidogrel plus aspirin (aspirin 100mg with clopidogrel 75mg for 21 days). The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis. The primary safety outcome was the moderate-to-severe bleeding event according to (GUSTO) definition. The secondary outcomes were new clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of an acute minor ischemic stroke or TIA
* Acute minor stroke was defined by a score of 3 or less at the time of randomization on the National Institutes of Health Stroke Scale (NIHSS; scores range from 0 to 42, with higher scores indicating greater deficits)

Exclusion Criteria:

* Intracerebral Hemorrhage
* Brain tumor
* Brain abscess, or other major non-ischemic brain disease;
* Isolated sensory symptoms (numbness, isolated visual changes, or isolated dizziness or vertigo) without evidence of acute infarction on baseline CT or MRI of the head
* A score of more than 2 on the modified Rankin scale, immediately before the occurrence of the index ischemic stroke or TIA, indicating moderate disability or worse at baseline
* An NIHSS score of 4 or more at randomization
* A clear indication for anticoagulation therapy (presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardiac valve) or a contraindication to clopidogrel, cilostazol or aspirin
* History of intracranial hemorrhage
* Anticipated requirement for long-term non-study antiplatelet drugs or for nonsteroidal anti-inflammatory drugs affecting platelet function
* Heparin therapy or oral anticoagulation therapy within 10 days before randomization
* Gastrointestinal bleeding or major surgery within the previous 3 months
* Planned or probable revascularization (any angioplasty or vascular surgery) within 3 months after screening (if clinically indicated, vascular imaging was to be performed before randomization, whenever possible)
* Planned surgery or interventional treatment requiring cessation of the study drug
* TIA or minor stroke caused by angiography or surgery
* Severe non- cardiovascular coexisting condition, with a life expectancy of less than 3 months