cyrilzakka/clinical-trials huggingface dataset:
Music Therapy as an Adjunct in CIED Lead Extraction Procedures

The study will investigate possible effects of music therapy as an adjunct in an invasive cardiac procedure where infected or broken pacemaker leads, or leads from implantable cardioverter-defibrillators are removed from inside the heart through the vein. The procedure is performed in local anaesthesia with the patient awake. Analgesic and anxiolytic drugs are given at the start of the procedure, and repeated if needed. In spite of the drugs, most patients will experience som degree of pain and/or anxiety and increased stress during the procedure. The music therapy intervention contains individually facilitated music listening and coping techniques, aiming to regulate stress responses. The music listening and guidance is provided by a certified music therapist before, during and after the invasive procedure.

See study protocol

Eligibility Criteria:
Inclusion Criteria:

1. Planned pacemaker or intracardiac defibrillator (ICD) lead extraction performed in local anaesthesia.
2. Lead implanted \> 12 months ago
3. Able to speak and read Norwegian
4. Willing to participate All inclusion criteria must be fulfilled.

Exclusion Criteria:

1. Significant hearing impairment
2. Previous and/or acute psychiatric diagnosis
3. Cognitive and mental deficits or impaired functioning
Validation of an Ankle Foot Orthosis With Anterior Support for Foot Drop

The objective of this research is to compare the new ankle foot orthosis (AFO) with prior support developed by Turbomed, with the AFO with posterior support from Turbomed as well as two competing AFOs currently on the market.

With this research, we seek to answer the following questions:

* Is the new AFO as biomechanically efficient as the AFOs currently on the market?
* Is the new AFO more comfortable than the AFO currently on the market?
* Is the new AFO easier to put on and attach than the AFOs currently on the market?


Eligibility Criteria:
Inclusion Criteria:

* Foot drop following surgery or an accident (functional calf, without contracture and not spastic)
* Foot drop following a Cerebral Vascular Accident (with or without spasticity, mild to moderate)
* Ability to stand and walk alone without technical assistance
* Ability to communicate comfort/discomfort

Exclusion Criteria:

* Sore to one of the feet
Muscle Activity and Kinematic Changes With Dry Needling

This study assesses the effects of dry needling with electrical stimulation to the low back on muscle activity and changes in movement. The investigators hypothesize that dry needling and electrical stimulation will elicit changes in muscle activity as well as changes in movement.

This study will utilize a Vicon motion capture system in conjunction with a Noraxon wireless surface electromyography system to analyze movements and muscle activity of each participant pre and post needling.

Eligibility Criteria:
Inclusion Criteria:

* English speaking individuals between the ages of 18 and 60 years old
* without current complaint of low back pain
* no history of low back or lower extremity surgery

Exclusion Criteria:

* individuals with current complaint of low back pain,
* lumbar radicular symptoms
* history of low back surgery or lower extremity surgery
* pregnancy or planning to become pregnant,
* currently taking immunosuppressant or anticoagulation use with INR not within therapeutic range
* needle phobia
* osteoporosis will be excluded
ADDIA Chronobiological Study

The present single center clinical chronobiological study on 24 subjects (12 patients with mild to moderate form of Alzheimer's disease and 12 Healthy subjects) aims at characterizing the ADDIA biomarkers: a) blood cell-based biomarkers measured by flow cytometry using proprietary probes specific of two targeted biomarkers, beta-Amyloid (Aβ) peptide and a kinase, and b) circulating biomarkers in peripheral body fluids. The biomarkers will be analyzed on samples taken at different time points of the day, including under fasting and non-fasting conditions and at two periods: day 1 and day 14.


Eligibility Criteria:
Inclusion Criteria for Alzheimer patient group:

* Signed Informed Consent.
* Male or female subject, between 55 and 85 years inclusive.
* Specific clinical phenotype of AD: Presence of an early and significant episodic memory impairment (isolated or associated with other cognitive or behavioural changes that are suggestive of a dementia syndrome) that includes the following:

  * Gradual and progressive change in memory function reported by patient or informant over more than 6 months.
  * Objective evidence of an amnesic syndrome of hippocampal type, based on significantly impaired performance on an episodic memory test with established specificity for mild to moderate AD.
* Cognitive tests including MMSE score 12 ≤ MMSE ≤ 25 for mild to moderate AD (measured in the last 3 months), b) Scores of other tests routinely practiced at the hospital for measurement of memory and cognition shall be compatible with mild to moderate AD.
* Neuroimaging compatible with a diagnosis of mild to moderate AD.
* Cerebrospinal fluid (CSF) biomarkers showing at least 2 positive levels out of the 3 biomarkers: CSF Aβ1-42 and tau (Phosphorylated-Tau and/or Total-Tau). CSF collection and data being only retrospective.

Inclusion Criteria for healthy controls:

* Signed Informed Consent.
* Male or female subject, between 55 and 85 years inclusive.
* Normal clinical and cognitive scores as measured using standard neuropsychological tests.
* Normal scores in other neuropsychological tests routinely practiced at the hospital for measurement of memory and cognition.
* No abnormal neuroimaging findings in at least structural MRI.

Exclusion Criteria:

* Any subject who did not sign the informed consent form.
* Any chronic neurodegenerative disease (vascular dementia, Parkinson's disease, Creutzfeldt Jacob, Huntington's disease, etc.), acute neurodegenerative disease (stroke), history or presence of clinically relevant psychiatric history (schizophrenia, psychosis), some chronic inflammatory diseases that impact blood cells (e.g. anemia of inflammation and chronic disease) and some cancers (that impact blood cells: e.g. leukemia), major sensory deficits that could interfere with cognitive assessment (visual and auditory), epilepsy.
* Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
* Blood donation, any volume, within 2 months before inclusion.
* Neutropenia (Neutrophils \< 1500/mm3).
* Thrombocytopenia (platelets: \< 100,000/mm3, rule out EDTA-induced pseudothrombocytopenia).
Bioequivalence Study of Torrent Pharmaceuticals Ltd's Alfuzosin ER Tablets Under Fed Conditions

Objective:

Primary objective of the present study was to assess the relative bioavailability of two formulations of Extended Release Alfuzosin 10 mg under Fed conditions, in healthy adult male subjects after an oral administration with 7 days washout period.

Study Design:

Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence Study


Eligibility Criteria:
Inclusion Criteria:

* The volunteers were included in the study based on the following criteria:

  * Sex: male.
  * Age: 18 - 45 years. .
  * Volunteer with BMI of 18-27 (inclusive both) kg/m2 with minimum of 50 kg weight.
  * Healthy and willing to participate in the study.
  * Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
  * Non-smokers or smoker who smokes less than 10 cigarettes per day

Exclusion Criteria:

* The volunteers were excluded from the study based on the following criteria:

  * Clinically relevant abnormalities in the results of the laboratory screening evaluation.
  * Clinically significant abnormal ECG or Chest X-ray.
  * Systolic blood pressure less than 100 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 60 mm Hg or more than 90 mm Hg.
  * Pulse rate less than 50/minute or more than 100/minute.
  * Oral temperature less than 95°P or more than 98.6°P.
  * Respiratory rate less than 12/minute or more than 20/minute
  * History of allergy to the test drug or any drug chemically similar to the drug under investigation.
  * History of alcohol or drug abuse
  * Positive breath alcohol test
  * Recent history of kidney or liver dysfunction.
  * History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
  * Volunteers suffering from any chronic illness such as arthritis, asthma etc.
  * History of heart failure.
  * HIV, HCV, HBsAg positive volunteers.
  * Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, - - - Cocaine positive volunteers based on urine test.
  * Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
  * Administration of any study drug in the period 0 to 3 months before entry to the study.
  * History of significant blood loss due to any reason, including blood donation in the past 3 months.
  * History of pre-existing bleeding disorder.
  * Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
  * Inability to communicate or co-operate due to language problem, poor mental development or impaired cerebral function.
Correlation Between NRT and Radiological Measurements in Detection of Position of the Electrode Inside the Cochlea.

The study will be conducted as Prospective study including 50 patients (aged \<6years ) at Otorhinolaryngology department, Assuit University Hospital (aged \<6years ) who will undergo cochlear implantation. All subjects will undergo implantation with Medel sonata flex 28 or standard electrodes with a standard surgical procedure. The standard surgical procedure will include extended end aural approach ,posterior tympanotomy and a round window insertion.The results of immediate postoperative Neural Response Telemetry (NRT) measurements \& postoperative CT imaging will be obtained.

Each patient will be subjected to the following scheme:

* immediate postoperative Neural Response Telemetry (NRT) measurements
* postoperative CT imaging
* Data obtained from both measurements will be used to determine the intra cochlear electrode position then both data will be correlated.

Cochlear implantation (CI) is a worldwide accepted and effective surgical procedure for patients with profound sensory neural hearing loss to gain near normal hearing.1 The position of electrode inside the cochlea affects the outcomes. Full insertion of the CI electrode array and insertion in scala tympani usually has optimal results and better words recognition.2 Translocation of electrode array from scala tympani to scala vestibule or outword migration of electrode array may result in poor response.2 There are many intraoperative and post operative techniques to determine the position of electrode array inside the cochlea, some are radiological as transorbital view plan x-ray or computed tomography or 3D rotational x ray and others are electrophysiological measurements.3 Although the accuracy of the radiological techinques they are time and cost consuming1. The electrically evoked cochlear action potential (ECAP) threshold is dependent on the distance between the electrodes and the spiral ganglion cells. The neural response telemetry-ratio (NRT-ratio) is one of the electrophysiological measurments techniques and it is based on each individual electrode's ECAP threshold and can identify the intracochlear electrode array position 4. According to a study done by Philipp Mittmann in 2015, a NRT-ratio above 1.05 indicates an electrode translocation from scala tympani to scala vestibuli and a NRT-ratio below 1.05 shows correlation to a pure scala tympani placement5, but another study found variation of the NRT-ratio in a group of patients with an electrode placement within scala tympani.6

Eligibility Criteria:
Inclusion Criteria:

* patients aged \< 6years who will undergo cochlear implantation

Exclusion Criteria:

* Revision cochlear implantation.
* incomplete post-operative electrophysiological measurements.
* unfit patients for surgery
Exploration of the Reward System by Functional MRI in Narco-cataplexy Patients With and Without REM Sleep Behavior Disorder

Up to 50% of Narcolepsy-cataplexy (NC) patients suffer from REM sleep behavior disorder (RBD), a parasomnia.

A strong link was found between RBD and impulse control disorders (ICD) in Parkinson disease (PD) patients. ICD are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so called ''reward system''.

A recent study in IRMf shows that RBD is associated with impaired reward system.

A strong link was found between these two disorders and therefore we believe that RBD is associated with impaired reward system in NC

The main objective of this study is to evaluate differences in brain activation between NC patients with and without RBD.

The investigators hypothesize that NC patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD.

Type of study: Prospective, case control study.

Number of centers: 3 (Clermont-Ferrand, Vichy and Montlucon)

Patients :

The study will be performed in 66 subjects (22 PD patients with RBD, 22 PD patients without RBD and 22 healthy volunteers, age-and sex-matched without any contraindications to perform an MRI)

Study Performance :

During the first visit (Baseline, inclusion visit, 2 hours), each subject will perform a clinical and neurological examination and neuropsychological assessment (depression by the Beck Depression Inventory (BDI); apathy by the Lille Apathy Rating Scale (LARS), impulsivity by the Urgency, lack of Premeditation, lack of Perseverance, Sensation Seeking scale (UPPS)) Eligible patients will be welcomed for a video Polysomnography in the sleep center, for one night (Month 1, 1 night) and in a subsequent visit at the MRI department for the functional MRI (Month 1, 1 hour). This session will be of about 45 minutes. The reward system will be explore using an experimental task during functional Magnetic Resonance Imaging (fMRI). The name of this task is the"monetary incentive delay task".

Eligibility Criteria:
Inclusion Criteria:

* - Men or women, right handed, 18 to 80 years
* Patients with type 1 Narcolepsy according to the criteria of the International Classification of Sleep, 3rd version, 2014
* Acceptance of the protocol and signature of a written consent
* Social security affiliation

Exclusion Criteria:

* Previous history of psychosis or psychiatric disease
* History of stroke or vascular lesion on MRI.
* Perceptual disorder (vision, hearing) may hinder the realization of the protocols,
* Dementia defined by a score across Montreal Cognitive Assessment (MoCA) \<26/30.
* Major depressive state defined by a score scale Beck Depression Inventory (BDI)\> 14
* Apathy defined by a score ≥ 14 on the Apathy Scale of Starkstein. Patients with a score ≥ this one will be excluded.
* Usual contraindications to MRI, knowing that no contrast agent injection is performed.
* Pregnant woman.
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2

This trial investigates the immunogenicity of FE 999049 in repeated cycles.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Documents signed prior to screening evaluations related to this protocol
* Participation in the pivotal efficacy trial (trial 000004/ESTHER-1)
* Anti-FSH antibody results from baseline and at least one post-dosing assessment in the previous cycle(s) available.
* Having undergone the oocyte retrieval procedure, or having had cycle cancellation prior to oocyte retrieval due to poor ovarian response or excessive ovarian response, in the previous cycle(s).
* Failure to achieve ongoing pregnancy in the previous cycle(s).

Exclusion Criteria:

* Non-compliance to protocol compliance in the previous cycle(s).
* Having undergone any stimulation with gonadotropins since the end-of-trial / end-of-cycle visit in the previous cycle
* One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to start of dosing on stimulation day 1
* Severe OHSS in a previous cycle.
* Any clinically relevant change to any of the eligibility criteria in the previous cycle(s).
* Clinically relevant medical history since the previous cycle which precludes gonadotropin stimulation or is associated with a reduced chance of pregnancy.
The Role of Vitamin D3 and Calcium Supplementation in Attenuating T2DM Severity

The purpose of this study is to investigate the effect of vitamin D3 and calcium supplementation in attenuating type 2 diabetes mellitus outcomes in ethnic diverse, diabetic patiens.

Subjects of this study received a total of 1800 IU vitamin D3 and 720 mg of calcium per day for 3 years. The study was conducted in Toronto, Ontario, Canada.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* Non-white, post menopausal female
* Have access to Community Health Center

Exclusion Criteria:

* neurodegenerative disease
* kideny disease
* gluten allergy
A Study of the Effects of Oxytocin in Adults With Obesity and Binge-eating Disorder

This study evaluates the impact of intranasal oxytocin vs placebo in patients with obesity and binge eating disorder with obesity. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes \[weight loss, reduction in bingeing frequency\], and have a satisfactory safety and tolerability profile. We will also explore the predictive value of changes in homeostatic appetite, reward sensitivity, and impulse control, the identified underlying mediators, as assessed 4 weeks into the intervention, for treatment success after 8 weeks of the intervention

Study staff will screen patients for eligibility as per eligibility criteria. At least 60 eligible patients will be randomized 1:1 (active oxytocin: placebo) by an unblinded pharmacist. All other study staff and test subjects will be blinded. Study subject medical histories, physical exams, anthropometric measurements, labs, EKG's, and eating habits will be monitored over 8 weeks. Subjects will be evaluated at the following intervals: Baseline, week 2, week 4, and week 8.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18-45 years old
* BMI 30-50 kg/m2
* BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV)

Exclusion Criteria:

* Substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at the time of screening based on history and/or laboratory results
* Medication changes within 4 weeks of baseline visit
* Use of prescription or over-the-counter drugs or dietary/herbal supplements for weight loss (e.g., lorcaserin, phentermine, topiramate, liraglutide). Metformin will be allowed if participants are on a stable dose with stable weight for at least 3 months
* History of any of the following medical conditions: inflammatory bowel disease; bariatric surgery (except for those participants with a history of laparoscopic adjustable gastric band surgery); epilepsy; untreated thyroid disease
* History of known cardiovascular disease, including coronary artery disease, heart failure, reduced ejection fraction, hypertrophic cardiomyopathy, ventricular arrhythmias, or prolonged QT
* Hematocrit \>2% below normal
* Hemoglobin A1c \>8%
* ALT or AST \>2.5 times upper limit of normal
* Glomerular filtration rate \< 60 mL/min
* Hyponatremia
* Pregnancy or breastfeeding
* Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
* History of psychosis or active suicidality as assessed by the SCID-5-RV
* Weight change \>5 kg within 3 months prior to randomization
* Current smoking or tobacco use
* Participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization
* Any significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or patient safety
The Efficacy of Topical Bupivacaine and Triamcinolone Acetonide Injection in the Relief of Pain After Endoscopic Submucosal Dissection for Gastric Neoplasia: A Randomized Double-blind, Placebo-controlled Trial

Although pain is a common complication of endoscopic submucosal dissection (ESD), management strategies are inadequate. bupivacaine is used for visceral pain control in chronic pain and in pain associated with surgery in clinical practice. Further, triamcinolone, a type of steroid, is often mixed with bupivacaine to lengthen the analgesic effect. The aim of this study was to evaluate the efficacy of topical bupivacaine and triamcinolone acetonide for abdominal pain relief and as a potential method of pain control after ESD for gastric neoplasia. We hypothesized that topical bupivacaine and/or triamcinolone acetonide injection after ESD would be effective for pain relief. For this, we designed randomized, double-blind, placebo-controlled trial. Eligible patients with early gastric neoplasm were randomized into one of three groups: bupivacaine (BV) only, bupivacaine with triamcinolone (BV-TA), or placebo. To evaluate the pain after ESD, the Present Pain Intensity (PPI) score and the Short-Form McGill Pain Questionnaire (SF-MPQ) were used to evaluate pain at 0, 6, 12 and 24 h after ESD.


Eligibility Criteria:
Inclusion Criteria:

* Age, between 20 and 80
* Patients who were scheduled to undergo ESD for gastric epithelial neoplasm at Severance Hospital between July 2012 and April 2013

Exclusion Criteria:

* Not providing written informed consent
* A history of any cardiac arrhythmias
* Current or regular use of analgesic medication for other indications
* Known other disease such as peptic ulcer disease or reflux esophagitis which could induce upper gastrointestinal pain
* Multiple lesions requiring ESD in a single patient
* Evidence of infectious disease or antibiotics therapy within 7 days prior to enrollment
* Participation in another clinical trial within 30 days prior enrollment
* Current pregnancy or breast feeding.