cyrilzakka/clinical-trials huggingface dataset:
Substitution of First Phase Insulin Response in Patient With Type 2 Diabetes.

The purpose of the project is to shown whether a little dose of a short acting insulin analogue given 3 time daily before the meals compared with placebo could normalise the increase in blood glucose after teh meals in diet treated Type 2 diabetic patients.

Patients with Type 2 diabtes has a defect in the insulinsecretion combined with an increased insulin resistance. At an intravenously glucosestimulation, patients with Type 2 diabtes has a decresed first phase insulin response compared to healty peoples. Because the hyperglycemia after meal, observed i Type 2 diabetics patients, is related to the defect in the first phase insulin response it is our hypothesis that substitution of the first phase insulin response with a little dose of insulin could normalise the blood glucose after the meal.

20 patients with Type 2 diabetes will in a randomised, placebocontrolled, dobble-dummy study be included for three days treatment with Insulin aspart vs placebo. Primary endpoint is bloodglucose fluctuations monitored by a continously glucose monitor.

Eligibility Criteria:
Inclusion Criteria:

Type 2 diabtes according to the WHO criteria Fasting blood glucose \>7 HbA1c between 6-9 Normal liver function Normal renal function

-

Exclusion Criteria:

Ongoing treatment with antidiabetic medicine Pregnancy and lactation -
Local Phase 4 Pan-European SMART Study

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period


Eligibility Criteria:
Inclusion Criteria:

* Patients at out-patient clinics
* \>18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief

Exclusion Criteria:

* Asthma exacerbation within the last 14 days prior to study start
* subject aged \>40 years with a smoking history of \>10pack-years
* subjects with chronic obstructive lung disease or other significant respiratory disease
Surgical Outcomes After Routine Cataract Extraction & Implantation of a Conventional or Spheric Intraocular Lens

To determine quality of vision post cataract extraction and intraocular lens (IOL) implantation of 2 different acrylic intraocular lenses: Acrysof® Single-Piece IOL and Acrysof® WF, through evaluation of contrast sensitivity, glare testing, visual outcomes, wavefront, corneal topography, and patient satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral cataract
* Eligible for phacoemulsification with primary implantation of a posterior chamber IOL. If bilateral, patient will receive the same IOL than the fellow eye.
* Expected maximum of 4 weeks and minimum of 1 week interval between primary and second eye surgeries when bilateral.
* Best corrected visual acuity (BCVA) should be no better than 20/40 in the presence of a glare source using Snellen visual acuity. In the Snellen visual acuity chart, better than 20/40 will be at least 3 letters read correctly in the 20/30 line.
* Naturally dilated pupil (in dim light) ≥ 4.0 mm in both eyes.

Exclusion Criteria:

* Preoperative ocular pathology potentially affecting visual acuity
* Previous intraocular or corneal surgery.
* Keratometric astigmatism exceeding 1.5 diopters.
* Planned postoperative refraction for mono-vision.
* Current contact lens usage.
* Other ocular surgery at the time of the cataract extraction.
* Uncontrolled diabetes.
* Any neurological condition that might interfere with performance of required test.
* Auto-immune deficiency disease.
* Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
* Use of any systemic or topical drug known to interfere with visual performance.

Surgical Exclusion Criteria

* Significant anterior chamber bleeding.
* Detached Descemet's membrane
* Iris damage
* Posterior capsule rupture
* Radial tear in capsulorhexis
* Vitreous loss
* Zonular rupture.
* Use of corneal sutures for more than 1 week.

Post-implantation Exclusion Criteria

* Haptic not in the capsular bag.
* Descentration of the IOL of more than 1.0 mm
* Ocular pathologies potentially affecting visual acuity that were not evident prior to surgery.
The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19

The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg versus placebo once daily administration with standard of care therapy for 14 days (maximum up to 21 days) in patients with moderate COVID-19.


Eligibility Criteria:
Key Inclusion Criteria:

1. Over 19 years of age
2. COVID-19 confirmed by a real-time RT-PCR tests 4 days prior to clinical trial enrollment
3. Patients with peripheral capillary oxygen saturation (SPO2) greater than 94% at the time of screening
4. Patients whose body temperature is measured according to the measured area without taking a fever reducer during screening:

   \[armpit of greater than 37.0 °C or an oral of greater than 37.2 °C; Patients with rectum greater than 37.6 °C or eardrum greater than 37.5 °C\] (Notes: Although you take a fever reducer, you can still be enrolled in after investigator's judgement whether there is fever or not.)
5. Patients with evidence of lung invasions as a result of radiation tests

Exclusion Criteria:

1. Patients who need breathing device (for example, Invasive ventilation, Invasive mechanical ventilation, Extra-corporeal membrane oxygenation).
2. Patients who participated in other clinical trials related to COVID-19.
3. Patients who were administered drugs directly to COVID-19 24 hours prior to the start of the study.
4. Patients whose AST or ALT has increased by more than 5 times the normal lab value.
Lighting and Human Response in Motor Time, Autonomic Nervous System, and Emotion

Light influences on human movement, autonomic nervous system, and emotion. It is inconclusive whether illuminance (Ev) and colour temperature (Tc) is appropriate to human movement, autonomic nervous systme, and emotion. Effect of Ev and Tc on responses of movement, autonomic nervous system, and emotion in human is investigated.

The adult and elderly sign informed consent form. They sit in a room where Ev and Tc is adjusted. During sitting they are measured response of movement, autonomic nervous system, and emotion.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 - 79 years old
* Normal visual acuity with or without own glasses or contact lens
* Normal visual field
* Normal visual color perception
* Able to following commands
* Able to read, write, and understand in Thai language
* Able to sit independently with or without support
* Able to move dominant upper limb
* No pain in dominant Shoulder, Elbow, Wrist, and Hand during movement

Exclusion Criteria:

* Aggravated pain at trunk and lower limb during movement of dominant upper limb
* Having Neurological disorders
* Having uncontrolled diseases
* Having psychological problems
A Pharmacokinetic Study of CJ30001 and HKB0701/SLM0807 in Healthy Subject

The objective of this study is to demonstrate the bioequivalence of CJ30001(fixed-dose combination tablet of HKB0701 and SLM0807) relative to HKB0701 and SLM0807 co-administered to healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. Ideal weight = \[height -100\]\*0.9
* Subjects with no history of any significant chronic disease
* Judged to be in good health on the basis of their vital sign, ECG, physical exam and routine laboratory data
* Available for the entire study period
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

* Subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration
* Subjects who have symptom of an acute illness within 4 weeks prior to drug administration
* Subjects with a history of clinically significant allergies including drug allergies
* Subjects whose clinical laboratory test values are outside the accepted normal range(Especially,AST or ALT \>1.25 times to normal range or total bilirubin \> 1.5times to normal range)
* Subjects with a history of drug, caffeine abuse(caffeine drink \>5cups/day)
* Subjects with a history of alcohol abuse(alcohol\>30g/day) or who have ever drinked alcohol whinin 7days prior to drug administration
* Heavy smoker ( \>10cigarettes/day)
* Subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice)
* Subjects who have donated plasma within 60days prior to drug administration
* Subjects who have participated in a clinical study within 90days prior to drug administration
* Subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator within 10days prior to drug administration (cimetidine within 7days prior to drug administration)
* Female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
Comparison of Three Meshes in Lichtenstein Hernia Repair

Chronic pain may be a long-term problem after inguinal Lichtenstein hernioplasty. The aim of this study was to compare long-term results of hernioplasty using three different meshes (partly absorbable, lightweight polypropylene and thick polypropylene mesh).

Inguinal hernioplasty was performed under local anesthesia in 300 patients in day-case surgery by the same surgeon and exactly by the same surgical technique. The patients were randomized to receive either a partly polypropylene-polyglactin mesh (Vypro II, 100 hernias), a lightweight polypropylene mesh (Premilene LP, 100 hernias) or a conventional densely woven polypropylene mesh (Premilene, 100 hernias). Pain, patients discomfort and recurrences of hernias were carefully followed 5 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* uni-or bilateral primary or recurrent inguinal hernia
* patients age \>18yrs

Exclusion Criteria:

* previous mesh hernioplasty
* femoral hernia
* emergency operation
* allergy to polypropylene
Magnetic Resonance Elastography of Cardiac Transplant Rejection

Magnetic Resonance Elastography (MRE) for cardiac transplant patients.

Patient will undergo MRE beginning 4-8 weeks post transplant, then with each scheduled cardiac biopsy through 7-8 months post transplant. Results of the MRE will be compared against results of the cardiac biopsy to determine if the non-invasive MRE can predict cardiac transplant rejection.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have undergone cardiac transplantation at the Ohio State University Ross Heart Hospital.
* Patients must be able to lie flat on their back in the scanner for up to 60 minutes
* Patient must be able to hold their breath for up to 15 seconds at a time.

Exclusion Criteria:

* Patients who are claustrophobic
* Patients who are pregnant, due to potential risks to the fetus.
* Patients with any unapproved, non-MRI safe metal/devices in their bodies.
Headache Inducing Effect of NN414 in Migraine Patients

To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.


Eligibility Criteria:
Criteria

Inclusion Criteria:

* Migraine patients of both sexes.
* 18-60 years.
* 50-100 kg.
* Women of childbearing potential must use adequate contraception.

Exclusion Criteria:

* Headache less than 48 hours before the tests start
* Daily consumption of drugs of any kind other than oral contraceptives
* Pregnant or nursing women.
* Cardiovascular disease of any kind, including cerebrovascular diseases.
* Diabetes mellitus and other endocrinologic disease
A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor

Primary Objective:

To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE

Secondary Objective:

To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE

Study Design:

This is a multi-center, randomized, double-blind, placebo-controlled, 3-period crossover study of rhC1INH in prophylaxis of angioedema attacks in patients with HAE.

Medical screening (clinical and laboratory parameters) will be performed and patient medical history specific to HAE attacks will be collected to assess eligibility. Each patient will receive three 4 week periods of treatment twice weekly.

Eligibility Criteria:
Inclusion Criteria:

Patients fulfilling the following criteria at Screening are eligible for participation in the study:

1. Age 13 years or older
2. Laboratory confirmed diagnosis of HAE
3. A history of frequent HAE attacks (at least 4 attacks per month across a minimum of 3 consecutive months).
4. Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception.
5. Provided written informed consent (and written assent for minors)
6. Willingness and ability to comply with all protocol procedures

Exclusion Criteria:

Patients who meet any of the following criteria at Screening are to be excluded from study participation:

1. Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)
2. Diagnosis of acquired angioedema (AAE)
3. Patients who are pregnant, or breastfeeding, or are currently intending to become pregnant
4. Treatment with any investigational drug in the past 30 days
5. Patients with any condition or treatment that, in the opinion of the Investigator, might interfere with the evaluation of study objectives
6. Patients currently treated with angiotensin-converting enzyme (ACE) inhibitors
UHCDS a-tDCS + TE in Fibromyalgia Patients

The present study aims to investigate the effect of a Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise on pain in subjects with FM.

Fibromyalgia (FM) syndrome is characterized as a cardinal symptom of chronic pain. It is one of the rheumatic diseases with the greatest impact on quality of life.

Although the etiology and pathophysiology are not yet completely clear, FM is related to specific changes in brain activity, such as a decrease in blood flow in the thalamus, caudate nucleus and pons tegmentum. This could be related to the appearance of a disorder in pain regulation, characterized by an alteration of the sensory and pain process in the central nervous system, due to neuroplastic changes in the neural circuits related to pain. Imaging studies have shown that FM could be associated with functional changes in the brain, such as a reduction in connectivity in efferent pain inhibitory pathways and central sensitization in afferent pain pathways, resulting in an increase in pain perception.

The most common FM treatment guidelines recommend aerobic exercise as the only non-pharmacological therapy with level A recommendation in the treatment of FM. In the same way, it concludes that it is more than recommended to combine therapies assuming synergistic effects between them.

Neuromodulation treatments with transcranial direct current stimulation (tDCS) have been shown to induce significant analgesia in FM through the modification of sensory processing of pain by thalamic inhibitory circuits. To date, the few studies that have combined tDCS and therapeutic exercise in FM have applied tDCS to the primary motor cortex (M1) in isolation. Currently, several studies conclude that Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation (UHCDS a-tDCS) on the dorsolateral prefrontal cortex (DLPFC) and M1 produces a 50% greater modulation of corticospinal excitability in healthy subjects. To date, there is no study that has evaluated the effectiveness of this novel application of tDCS in subjects with FM on pain.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
* Usual pain intensity of 4 or more points on a visual analogue scale.
* Able to participated in a therapeutic exercise program.
* Understanding of spoken and written Spanish.

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Metallic implants in the head.
* Tumor, trauma or surgery in the brain.
* Epilepsy or stroke.
* History of substance abuse in the last 6 months.
* Use of carbamazepine in the last 6 months.
* Diagnosed psychiatric pathology.
* Rheumatic pathology not medically controlled.
* Coexisting autoimmune pathology.
* Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).
A Pharmacokinetic and Pharmacodynamic Study of Metformin and Canagliflozin in Healthy Adult Volunteers

The purpose of the study is to investigate the potential interaction between multiple oral doses of canagliflozin and a single oral dose of metformin in healthy adult volunteers.

This is an open-label (volunteers will know the names of treatments they are assigned) single-center study of canagliflozin and metformin in healthy adult volunteers. Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM) and metformin is an approved treatment for patients with T2DM. Canagliflozin will be administered orally (by mouth) as a single 300-mg tablet on Days 4, 5, 6, 7, and 8 and metformin will be administered orally as two 1,000 mg tablets on Days 1 and 8. Both canagliflozin and metformin tablets will be taken with 8 ounces (240 mL) of water.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive.

Exclusion Criteria:

* History of or current clinically significant medical illness as determined by the Investigator
* History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose
* Known allergy to canagliflozin or metformin or any of the excipients of the formulation of canagliflozin or metformin
* Known allergy to heparin or history of heparin induced thrombocytopenia.
Immersive Virtual Reality in Post Stroke

Physiotherapy intervention programs in the post-stroke patient should develop strategies to assess functional deficit, prevent poorly adaptive plasticity and maximize functional gain. For relearning and functional training, the required activities require motor control and must comply with the following principles: movements close to normal, muscular activation, movement conduction, focused attention, repetition of desired movements, specificity of training, intensity and transfer. These principles underlie the most widely used conventional physiotherapy intervention programs in the hospital setting.

Advances in technology have made it possible to start using immersive VR in the therapeutic approach to various pathologies that affect motor function.

Physiotherapy intervention programs in the post-stroke patient should develop strategies to assess functional deficit, prevent poorly adaptive plasticity and maximize functional gain. For relearning and functional training, the required activities require motor control and must comply with the following principles: movements close to normal, muscular activation, movement conduction, focused attention, repetition of desired movements, specificity of training, intensity and transfer. These principles underlie the physiotherapy intervention programs specifically most used in the hospital setting.

Main aims

1-To determine if the designed immersive VR training program is better in the short term (15 sessions) and in the medium term (30 sessions) than the conventional physiotherapy training with respect to the change of the parameters related to the static balance in sitting and standing and dynamic balance in post-stroke patients.

Secondary aims 2. To determine the efficacy in the short term (15 sessions) and in the medium term (30 sessions) of immersive VR systems compared to conventional physiotherapy procedures regarding the quality of life associated with stroke, the degree of independence and autonomy .

3. To determine the safety of the application of training programs in immersive VR settings in post-stroke subjects with respect to the number of adverse effects produced.

4. Determine prognostic factors associated with insufficient improvement (less than moderate change) after stroke treatment with the designed immersive VR program and with conventional physiotherapy treatment.

Eligibility Criteria:
Inclusion Criteria:

* Adults\> 18 years and \<80 years.
* Diagnosis of hemiparesis or post-stroke hemiplegia.
* Minimum score of 2 points on item 3.2 of the Berg Scale, which establishes that the patient can remain in a sitting position for 30s without help.

Exclusion Criteria:

* Aphasia, scores over 45 on the Mississippi Aphasia Screening Test.
* Cerebellar pathology.
* Hemineglect or previous neurological disorder.
* Visual disturbances that prevent the use of VR glasses.
* Moderate cognitive decline, scores less than 43 on the Mini-mental State examination.
* Previous musculoskeletal disorders that make it difficult or impossible to balance sitting and standing or walking.
SCFE Longitudinal International Prospective Registry

Slipped Capital Femoral Epiphysis (SCFE) is the most common disorder of the adolescent hip and diagnosis and treatment of SCFE remain areas of controversy and investigation. The current issues relating to diagnosis stem from an inability to diagnose the condition early on, resulting in increased morbidity. Once diagnosed, there are multiple different options for surgical treatment, including in-situ pinning, and the Modified Dunn procedure. Research is ongoing to determine the parameters that should be considered when selecting a procedure to ensure an ideal outcome. In particular, there is a focus on investigating which treatment method may result in lower incidence of avascular necrosis of the femoral head and femoroacetabular impingement (FAI), two significant long term concerns associated with SCFE. Despite myriad published studies on SCFE, very few are prospective and most lack sufficient patient numbers for clinically meaningful comparative analysis. The aim of this study is to develop a multi-center, international prospective registry of patients with SCFE to facilitate the comprehensive examination of clinical, functional and radiographic outcomes of each treatment, in relation to specific parameters determined prior to intervention. The general registry will serve as a hypothesis-generating database of prospectively collected outcomes. In turn, this will facilitate the development of targeted, hypothesis-testing randomized controlled trials and observational studies that can be housed within the larger registry.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of SCFE
* Intend to receiving follow-up at participating centre
* Less than 18 years old at time of admission
* Adequate diagnostic information and radiographic imaging (for patients previously treated for SCFE)

Exclusion Criteria:

* No definitive diagnosis of SCFE
* Do not intend to receive follow-up at a participating centre
* Greater than 18 years old at time of admission
* Prior treatment for SCFE not appropriately documented
* Known or suspected underlying conditions (e.g., cerebral palsy, spina bifida, or osteogenesis imperfecta)