cyrilzakka/clinical-trials huggingface dataset:
Comparison Three Vs Six Months of Dual Anti-platelet Therapy After Sirolimus-eluting Stent Implantation

This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aims to assess the clinical non-inferiority of 3 months (short-term) vs 6 months (long-term) of Dual Anti-Platelet Therapy (DAPT) in patients after implanted NOVA intracranial sirolimus-eluting stent system. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 12 months of DAPT at index procedure.

This study will recruit 478 subjects with intracranial atherosclerotic stenosis (ICAS) in China. All participants met the inclusion criteria will be 1:1 randomized to 3 months or 6 months of DAPT after implanting NOVA stent. Clinical follow-up will be carried out at 30 days, 3 months, 6 months, 12 months, 1 year, 2 years, 3 years, 4 years and 5 years after index procedure. The primary endpoint is the composite endpoint of any stroke, death and major bleeding (intracranial or systemic bleeding requiring hospitalization, blood transfusion or surgery) at 1 year.

Eligibility Criteria:
Inclusion criteria

1. Males or females between 35 and 80 years of age.
2. Symptomatic intracranial arteriosclerosis stenosis with reference diameter 2.25-4.00mm;.
3. Intracranial artery stenosis (≥70%) conformed by DSA.
4. Subjects who voluntarily participate in the study and sign informed consent form.

Exclusion Criteria:

1. Subjects who have surgery within previous 30 days or plan to perform major surgery in the next 90 days (surgery grade 3 and above).
2. Subjects of acute hemorrhagic stroke within 3 months.
3. Disabling stroke with a baseline mRS score ≥3.
4. Lesion artery with severe calcification and close neighbour stenosis.
5. Non-atherosclerotic diseases (e.g. arterial dissection, Moya Moya disease, vascular inflammatory lesions caused by infection, autoimmune diseases, post-irradiation, postpartum status; developmental or genetic abnormalities such as fibromuscular dysplasia, sickle cell anemia, suspected vasospasm).
6. The ischaemic event that is highly suspected to be due to vascular embolism from an extracranial arterial segment such as ipsilateral neck/chest arterial occlusion) or cardio embolism such as atrial fibrillation, mitral stenosis, left ventricular thrombus, patent foramen ovale, myocardial infarction within 6 weeks, etc.
7. More than 50% stenosis of the supplying artery of the lesion artery: 1) MCA severe stenosis (lesion artery) with more than 50% stenosis of ipsilateral ICA (supplying artery). 2) Basilar artery severe stenosis (lesion artery) with more than 50% stenosis of dominant VA (supplying artery) stenosis.
8. Accompanied by intracranial tumours or intracranial arteriovenous malformations.
9. The patient who is allergy response to heparin, aspirin, clopidogrel, rapamycin, contrast agents, anaesthetics, or drug eluted stent components.
10. Women who are pregnant or lactating.
11. Due to cognitive or emotional disorders or mental illness, the patient who cannot finish the follow-up.
12. Investigators consider the patient who is not suitable for enrolling in the present trial.
Safety and Efficacy of Celecoxib Versus Placebo in the Treatment of Knee Osteoarthritis in Patients Who Were Unresponsive to Naproxen and Ibuprofen

To compare the efficacy and safety of celecoxib versus placebo for the treatment of knee osteoarthritis (OA) in patients who were unresponsive to prescription strength naproxen and ibuprofen or who could not tolerate prescription strength naproxen and ibuprofen


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

* Diagnosed, active, and symptomatic OA of the knee in a flare state with a functional capacity class of I-III at baseline visit
* Failed adequate trials of both naproxen and ibuprofen (prescription strength) within the past 5 years due to lack of efficacy, tolerability, or both; duration of prescription strength ibuprofen and naproxen must have been a minimum of 2 weeks for each drug at the respective recommended doses if failure was due to lack of efficacy, and for any duration if failure was due to lack of tolerability

Exclusion Criteria:

Exclusion criteria:

* Inflammatory arthritis or gout/pseudo-gout with acute flare within the past 2 years (subjects with fibrositis or fibromyalgia will not be excluded)
* Received acetaminophen within 24 hours of the baseline visit
* Use of a mobility assisting device for less than six weeks prior to study screening or use of a walker
* History of gastrointestinal (GI) perforation, obstruction, or bleeding
* Diagnosed or treated for GI ulcer within 60 days prior to first dose of study medication
* Received corticosteroids or hyaluronic acid within certain timeframe before study
Efficacy of Hydrotherapy on Balance in Neuropathic Patients Post-Burn

Balance problems are common among neuropathic patients following burns, primarily due to sensory and motor impairments.The goal of the study is to investigate the effect of a hydrotherapy program on balance in neuropathic patients following burns. It is a randomized controlled study will be conducted on fifty male patients (age range from 35 to 45 years) with polyneuropathy following lower limb burn injuries, mainly at the sole of the foot, with 3rd-degree injuries and 30% burn extent.

Balance will be assessed before and after treatment using the Biodex Balance System and the Berg Balance Scale (BBS).

Patients will be randomly assigned into two equal groups:

Group A (study group) will receive hydrotherapy sessions including stretching, resistance, and balance exercises in water.

Group B (control group) will receive traditional land-based balance exercises only.


Eligibility Criteria:
Inclusion Criteria:

* polyneuropathy following burn injuries of the lower limb mainly at the sole of the foot.
* 3rd-degree injuries and 30% burn extent.
* Patients' ages range from 35 to 45 years,
* Ability to understand instructions and following commands.

Exclusion Criteria:

* balance disturbances due to neurological disorders other than polyneuropathy (e.g., Parkinson's disease, inner ear disorders, vestibular or cerebellar dysfunctions).
* Uncontrolled hypertension.
* Diabetes mellitus,
* Cognitive impairments
* Blindness.
* Deafness.
* Significant respiratory or cardiac conditions.
Phase I/II Safety and Immunogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1) in Healthy Thais

The purpose of this study is to evaluate safety and reactogenicity of Pandemic Live Attenuated Influenza Vaccine (PLAIV) manufactured by GPO, Thailand, and to evaluate humoral immune response of the above vaccine after intranasal application by using HAI test, micro neutralization assays.

Part A: 24 volunteers will be enrolled and divided into 2 groups -12 volunteers in each of 2 groups receiving either 5.0-6.5 log 10 EID50 or 6.6-7.5 log10 EID50 respectively. 9 who will received vaccine vaccine strain and 3 who will received placebo.

Part B: Total 324 participants will randomized into 2 group using 3:1 ratio (300 vaccines:100 placebos). There are 3 stratified age groups: \>12-18 years, \>18-49 years and \>49 years.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Age 9 - \>49 years old
* Having Thai ID card or equivalent
* Are seronegative to the specific H1N1 influenza virus determined by antibody titer less than 1:10 by HAI test to the corresponding antigen
* Anti HIV - Negative
* All hematology \& biochemistry within normal range
* Able to read and write and sign written informed consent

Exclusion Criteria:

* Known history of egg allergy
* Having had recently influenza infection confirmed as H1N1 (indeed all other types if Influenza and vaccination with seasonal vaccine will not interfere)
* History of bronchial asthma
* History of chronic lung diseases
* History of chronic rhinitis
* History of immunodeficiency state
* History of immunosuppression
* Acute infectious and noninfectious diseases (within 2 weeks)
* Exacerbation of chronic diseases or cancer or HIV positives
* Anamnestic leukocytosis, hepatitis B and C positives
* The volunteers who have been taking immunoglobulin products or have had a blood transfusion during past three months before the beginning of the experiment
* Participation in other research study
* Pregnancy or plan to become pregnant for 60 days after enrollment or breast feeding
* Any concomitant medication with Aspirin
Cognitive Flexibility Training in Persistent Pain

To determine whether participation in a cognitive training program over a training period of five weeks improves cognitive flexibility in patients with chronic hip, knee, and back pain.

This project is a single-center prospective, randomized study to assess whether cognitive flexibility can be improved through training on a Lumosity®-based training module over the course a five week timeframe in patients with chronic hip, knee, and back pain; and whether changes in cognitive flexibility will correlate with perceived pain scores.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 to 70 with chronic hip, knee, or low back pain for \>3 months
* Documented moderate to severe chronic pain
* English as a primary language
* Access to a computer at home and an email account

Exclusion Criteria:

* Diagnosed Alzheimer's or documented severe cognitive impairment
* Lack of email/lack of basic computer skills
* Has undergone an interventional pain procedure within one week prior to enrollment
* Are scheduled to undergo a pain procedure during the five weeks of complete cognitive training
Impact of Priming the Infusion System on the Performance of Target-controlled Infusion of Remifentanil

The investigators attempted to determine an adequate priming volume for our infusion system, and investigated the extent of a possible delay of the drug effect, that would result from mechanical defects of the infusion system, with or without priming the infusion system, using direct gravimetrical measurements of virtual infusate amounts during target controlled infusion of 2 remifentanil diluents.

Priming the infusion system (PRIMING) was performed using an evacuation of 2.0 ml to the atmosphere prior to Target-controlled Infusion (TCI). Forty eight TCI, using 50 μg/ml or 20 μg/ml of remifentanil diluents, were performed targeting 4.0 ng/ml of effect site concentration (Ceff), with or without PRIMING. Using simulations, the gravimetrical measurements of the delivered infusates reproduced actual predicted concentrations.

Eligibility Criteria:
Inclusion Criteria:

* electric medical records of the patients who had undergone general anaesthesia

Exclusion Criteria:

* body weight exceeding 20% of ideal body weight
Short-term Effects of a Carob Snack on Postprandial Glycemic Responses and Energy Intake and Satiety

This study investigated any potential associations between two preloads offered as snacks and postprandial glycemic response, subjective and objective appetite and energy intake in healthy, normal-weight adults.

This study aimed at 1. firstly determine the glycemic index (GI) of a carob snack compared with an isoenergetic, equal weight chocolate cookie and 2. test the hypothesis that a carob preload consumed as snack before a meal, compared to chocolate cookie would: (a) have greater short-term effect on satiety measured by subsequent ad libitum meal intake, (b) induce greater satiety as assessed by visual analogue scales (VAS), and (c) reduce postprandial glycemic response.

Eligibility Criteria:
Inclusion Criteria:

- Healthy, non-smoking, non-diabetic men and women individuals with normal body mass index (BMI; between 18.5 and 24.9 kg/m2)

Exclusion Criteria:

* Severe chronic disease (e.g. tumors, manifest coronary heart disease, diabetes mellitus, severe kidney or liver conditions, endocrine and immunological conditions)
* Gastrointestinal disorders (e.g. chronic inflammatory bowel disease)
* Lactose intolerance
* Pregnancy
* Competitive sports
* Lactation
* Alcohol
* Drug dependency
Non-invasive Brain Stimulation to Enhance Treatment of Dysarthria Post-stroke

The proposed study aims to determine if transcranial direct current stimulation can enhance the effect of speech therapy in post-stroke patients with dysarthria.

A total of 60 Cantonese-speaking post-stroke patients who are suffering from dysarthria will be recruited and randomly divided into real tDCS and sham groups. All the participants will receive individualized speech therapy based on the results of their speech assessment.

For the real tDCS group, an anodal high-definition tDCS of 2 milliamperes (mA) lasting for 20 minutes will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy. For the sham tDCS group, stimulation given during speech therapy will only last for 30 seconds in order to cause a similar sensation on the scalp as the real stimulation group. There will be a total of 10 daily sessions during a 2-week period.

Eligibility Criteria:
Inclusion Criteria:

* Cantonese-speaking adults who had their first stroke and have suffered dysarthria post-stroke.
* Both acute and chronic stroke participants will be recruited.

Exclusion Criteria:

* Individuals with a personal or family history of epilepsy or seizures;
* Individuals with a history of another neurological condition (which is not a result from the initial stroke);
* Individuals with a history of speech disorders, voice disorders, oro-maxillo-facial surgery involving the tongue and/or lip, severe cognitive impairment, severe aphasia;
* In an unstable or serious medical condition;
* Have a cardiac implant metallic foreign body implant and/or any medications that lower neural thresholds (e.g. antidepressants, neuroleptic agents, etc.).
Cholecystectomy Blunt Dissection

Day case laparoscopic cholecystectomy can be made with conventional diathermy hook starting at triangle of Calot´s. 5mm suction irrigation blunt dissection starting from the gallbladder fundus is another option. The aim is to test the hypothesis that with 5mm suction irrigation blunt dissection technique a better same day discharge and a shorter operative time can be achieved.

After initiation of general anaesthesia patients are randomized either to conventional(cautery) or 5mm suction irrigation blunt dissection group. The patients and recovery room personnel are blinded to the operative technique used.

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* BMI under 35
* normal liver enzymes
* no bile duct dilatation in ultrasound
* cholecystolithiasis

Exclusion Criteria:

* NSAID allergy
* previous upper gi-surgery
* common bile duct stones in preoperative imaging
* history of severe acute pancreatitis
Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy

This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.

Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 30 patients with ischemic retinopathy, including diabetic retinopathy with severe loss of retinal capillaries undergoing intravitreal injection of bone marrow derived stem cells.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Ischemic Retinopathy
* Enlargement of foveal avascular zone-FAZ (ischaemia or capillary drop out of \>30% on Fluorescein retinography
* logarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse
* Able (in the Investigator's opinion) and willing to comply with all study requirements

Exclusion Criteria:

* previous ocular surgery other than cataract
* presence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation
* other ophthalmic disease like glaucoma and uveitis
* previous history of blood disorders like leukemia
* known allergy to fluorescein or indocyanine green
Efficacy of EXPAREL in Comparison to Standard of Care for the Treatment of Post Operative Dental Implant Pain

This study is researching managing postsurgical pain by injecting both short-acting local anesthetics and EXPAREL® at the time of surgery and reviewing if it could reduce or eliminate the need for postsurgical opioids and improve clinical outcomes following the FAST dental implant surgery procedure. This approach is being compared to the current standard of care.

Postsurgical pain following the Full Arch Surgical Therapy (FAST) dental implant surgery procedure is commonly managed with a variety of interventions, including local infiltration with short-acting local anesthetics during surgery and the use of postsurgical opioid and non-opioid analgesics. Although this approach to managing postsurgical pain is considered the current standard of care, its reliance on opioid analgesics to provide analgesia beyond the duration of short-acting local anesthetics exposes patients to opioid-related adverse events (ORAEs) that may delay their recovery and have other deleterious clinical consequences. The primary objective of this study is to determine the efficacy and safety of local infiltration of EXPAREL for the FAST dental implant surgery procedure compared to standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older;
* Ability to speak, read, and write in English;
* Ability to communicate via telephone;
* Scheduled to undergo FAST dental implant surgery procedure at a study center within the next 30 days for both maxillary and mandibular repair with at least 4 upper and 4 lower teeth to be extracted;
* Willing to provide informed consent, participate in study, and comply with study protocol.

Exclusion Criteria:

* Daily opioid consumption for more than 30 days prior to surgery;
* Any opioid consumption within 3 days prior to surgery.
* Prior treatment for alcohol, recreational drug, or opioid abuse.
* Hypersensitivity or allergy to local anesthetics, non steroidal anti-inflammatory drugs, or opioids;
* Breastfeeding, pregnant, or contemplating pregnancy prior to surgery.
Comparing Paroxetine and Duloxetine on Cardiovascular Measures

This double-blind placebo-controlled trial is designed to test and to compare the cardiovascular profile of paroxetine controlled release (CR) with duloxetine in outpatients with depressive symptoms.

This double-blind placebo-controlled study will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine than paroxetine in outpatients with major depressive disorder. We will also examine the relationship between changes in heart rate variability to the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug.

Eligibility Criteria:
Inclusion Criteria:

* Depressive symptoms
* Ages 20-60
* In good medical health and not pregnant

Exclusion Criteria:

* Bipolar disorder
* Schizophrenia or other psychotic disorder
* Alcohol or other substance abuse within the last 3 months
* Cognitive impairment
* History of attempted suicide in the past 2 months and who score 4 or more on the suicide item of the MADRS
Using Different Kinds of B-cun Scales to Mark Some Acupoints at Governor Vessel on the Head

We are expecting that there are remarkable differences location at BaiHui(GV20) or Houding(GV19)showing from same person in our study.


Eligibility Criteria:
Inclusion Criteria:

healthy volunteers

Exclusion Criteria:

1. craniectomy
2. Psychotic symptoms
Sleep Disordered Breathing and Its Impact on Neuro-cognitive Performance and Quality of Life in Parkinson Disease

The purpose of this study is to determine the impact of sleep and breathing problems during sleep on memory, attention, and general well being (quality of life) in people with Parkinson Disease.

During the 2 year award period, we will prospectively enroll 200 patients with idiopathic Parkinson Disease (PD), who meet eligibility criteria below. All patients will undergo a baseline polysomnography (PSG) to diagnose Sleep Disordered Breathing (SDB) and will be asked to complete validated questionnaires to measure Sleep Quality, SDB risk, insomnia severity, daytime sleepiness, presence of restless leg syndrome (RLS), anxiety/depression, and quality of life. Medical records will be reviewed to determine co-morbidities and medication use. Each PD participant will undergo a full neurological examination, including the Unified Parkinson's Disease Rating Scale (UPDRS), the Hoehn \& Yahr stage and a battery of neuro-cognitive measures at baseline. Patients with SDB will be offered PAP titration and treatment for 4 months. All patients (SDB \[PAP compliant, non-compliant\], and no SDB \[controls\]) will complete repeat neuro-cognitive evaluation, questionnaires, neurological evaluation and UPDRS assessment at 4 month and at 1 year follow-up. PD participants will be assessed in the "on" state in the morning. In the event that a participant goes "off" during testing, a break will be taken and participants will be given the option of taking their medication to return to the "on" state and resume testing or they can return later in the week to complete the evaluation. Although participants will understand the general purpose of the study, they will be blinded to the major study hypothesis. Neuropsychological examiners and the neurologist conducting the neurological exam will be blinded to the SDB status of the patient. Four month follow-up will be staggered according to enrolment date and will be completed by Year 2.

Eligibility Criteria:
Inclusion Criteria:

* Able to give consent.
* ≥18 years and have a Hoehn and Yahr stage at the time of enrollment of ≤3, clinical diagnosis of idiopathic Parkinson's Disease meeting the United Kingdom Parkinson's Disease Society Brain Bank criteria.
* Stable medical condition, including medications in the 1 month prior to enrollment.

Exclusion Criteria:

* Previous diagnosis of SDB with active use of Positive Airway Pressure (PAP), surgery for SDB or tracheostomy.
* Inability to read and comprehend English and/or Spanish at a grade 5 level.
* Prior history of neurosurgical procedures for PD or any other condition.
* Diagnosis of dementia as defined by Mini-mental state examination (MMSE) of \< 26.
* History of major uncontrolled psychiatric illness.
* History of drug or alcohol abuse/dependence.
* History of major head injury or other neurological disease.
* Patients with observable craniofacial abnormalities that may be a relative contraindication to PAP.