cyrilzakka/clinical-trials huggingface dataset:
Comparison of Two Approaches to Insulin Therapy in Patients With Type 2 Diabetes (IOOX)

A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes
* Have been receiving oral antihyperglycemic medications (OAM) without insulin including at least two of the following at maximally tolerated doses, AND meet the minimum dosing criteria shown: Metformin 1500 mg/day, Sulfonylurea 1/2 the maximum daily dose, according to package insert, Thiazolidinedione (TZD) 30 mg/day pioglitazone or 4 mg/day rosiglitazone. The OAMs also must be used in accordance with the product label
* Have a hemoglobin A1c greater than or equal to 7.5% and less than or equal to 12.0%.

Exclusion Criteria:

* Are taking a TZD dose greater than what is indicated in combination with insulin according to the TZD label.
* Are taking any other glucose-lowering agents not mentioned in Inclusion Criterion.
* Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks or for a total of 30 days or more in the last 24 weeks.
* Have a body mass index greater than 40 kg/m2.
* Have had more than one episode of severe hypoglycemia in the last24 weeks
* Are pregnant, intend to be pregnant during the course of the study or are breastfeeding
* Have clinically significant cardiac, renal, hematologic, oncologic, or hepatic disease
Predicting Hypotension Related to Spinal Anesthesia for Caesarean Section With Ultrasonography

Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by a hypotension in 40% to 90% despite preventing tools. Hypotension is responsible of foetale and maternal suffering. It would be interesting to have a tool that could detect patient who are at risk to have hypotension.This study consist in measuring variations of under aortic velocity peak (ΔITVAo) which estimate the modification of the cardiac output by Trans thoraciq echography.

Spinal anesthesia is the main technique for caesarean section. This anesthesia is followed by a hypotension in 40% to 90% despite preventing tools (fluid challenge and vasoactives drugs). Hypotension is responsible of foetale and maternal suffering. Fluid challenge is able to upgrade cardiac output for some patient, for some other it is unusefull or it can deteriorate it. Actually fluid challenge is not individualized. It would be interesting to have a tool that could detect patient who are at risk to have hypotension.

Trans thoraciq echography is an easy non invading tool. Dynamic criteria which is recognized for predicting vascular filling , with spontaneus breathing, is the passive leg rising (PLR). PLR mime à vascular filling of 500 ml. Modification of this cardiac outpout is measured whith the echocardiograph. This consist in measuring variations of under aortic velocity peak (ΔITVAo) which estimate the modification of the cardiac output.

Eligibility Criteria:
Inclusion Criteria:

* Included patient are all women having a spinal or spinal-epidural anesthesia for elective caesarean section. All patients are more 18 years old and more 37 weeks pregnancy.

Physical statut score (ASA):1 or 2

Exclusion Criteria:

* Woman presenting a contraindication to the spinal epidural anesthesia : constitutional or acquired disorder of the haemostasis
* allergy in the local anesthetics,
* infectious context (hypertherm \> 38.5 ° C)

  · cardiac, right or left Insufficiency
* eclamptic toxemia
COMParison of the EffecT of dEvice Closure in Alleviating Migraine With PFO (COMPETE-2)

Migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (PFO). Clinical Observational studies have been linking PFO occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. However, several RCTs have shown negative primary results, making it unclear whether PFO occlusion is effective in treating migraine. Our study is a prospective, double-blind, multi-center, and randomized study designed to test the effectiveness of migraine alleviation by performing percutaneous closure of patent foramen ovale in patients who are also diagnosed with PFO and migraine.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 ；
2. Diagnosed migraine by ICHD-3
3. History of migraine longer than 1 year
4. TCD/TTE/TEE diagnosed patent foramen ovale
5. Willing to participant and agree to follow-ups
6. Undertook medication therapy for three months without a responder rate higher or equal to 50%

Exclusion Criteria:

1. Migraine caused by other reason
2. Had TIA/stroke history
3. Hypersensitive or hyposensitive to the study drug
Safety & Efficacy of Symbicort® Turbuhaler® (1, 2, and 4 x 160/4.5 µg Twice Daily) in Japanese Patients With Asthma

This study is to confirm the safety of Symbicort® Turbuhaler® 160/4.5 µg 1, 2 or 4 inhalation b.i.d. over a 52 week treatment period in asthmatic patients who are being treated with IGCS and long acting β2-agonist (LABA) and/or other anti-asthmatic drugs.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of asthma with a documented history of at least 6 months duration prior to Visit 1
* Prescribed daily use of an IGCS for ≥12 weeks prior to Visit 1
* Prescribed daily use of at least one of the following:

Theophylline, long acting β2-agonist (LABA), other anti-asthmatic drugs (leucotrine antagonists, inhaled anti-cholinergics, Th2 cytokine inhibitor) for at least 4 weeks prior to Visit 1 at a constant dose

Exclusion Criteria:

* Any significant disease or disorder that may jeopardize the safety of the patient
* Respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to Visit 1
* Treatment with oral, parenteral or rectal GCS within 4 weeks prior to Visit 1
Patient Satisfaction in Post-LASIK Patients With Presbyopia-Correcting IOLs vs. Post-Lasik Patients With Monofocal IOLs

Compare functional visual outcomes and patient satisfaction of post-LASIK patients having received presbyopia-correcting IOLs versus post-LASIK patients having received monofocal IOLs


Eligibility Criteria:
Inclusion Criteria:

* Post-LASIK
* Post cataract surgery
* Implantation of ZLB00, ZXR or ZXT, ZCB00, or AO60 intraocular lenses
* Spherical values greater than ± 0.50 and/or cylinder magnitude greater than 0.75D

Exclusion Criteria:

* Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
* Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
* Max sphere no greater than ± 0.50D and cylinder less than and/or equal to 0.75D
Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT

Background: Among preterm infants, those born at a gestational age less than 26 weeks are considered the most vulnerable with a high risk of short- and long-term health problems that include chronic lung disease, brain bleeds, gut injury, kidney failure and death. Patent ductus arteriosus (PDA) is the most common heart condition with almost 70% preterm infants in this gestational age group being diagnosed with a PDA. Though many PDAs spontaneously resolve on their own, research suggests that if the PDA persists, it may contribute to a number of these short- and long-term health problems. Non-steroidal anti-inflammatory medications such as ibuprofen are commonly used to treat a PDA. Such drugs can also have harmful effects on the gut and kidneys of extremely preterm infants. Therefore, we are unsure if early treatment of a symptomatic PDA in this age group is at all beneficial. Given the wide variation in PDA treatment approaches in this age group, a randomized trial design, where extremely preterm infants with a symptomatic PDA are randomly assigned to early treatment or no early treatment, is essential to address this question.

Purpose of the study: The overall purpose of this pilot study is to assess the feasibility of conducting a large study to explore the following research question: In preterm infants born \<26 weeks' gestation, is a strategy of selective early medical treatment of a symptomatic PDA better than no treatment at all in the first week of life?

The main feasibility objectives of this study are:

1. To assess how many eligible infants can be enrolled in the study
2. To assess how many enrolled infants properly complete the study protocol

Importance: To our knowledge this will be the first study on PDA management in preterm infants that specifically aims to enroll preterm infants born at \<26 weeks of gestational age who are at the highest risk for PDA-related problems but have been mostly under-represented in previous PDA studies.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants less than 26 completed weeks (i.e., up to and including 25 weeks and 6 days) of gestation

Exclusion Criteria:

* no PDA on initial screening echocardiography
* congenital heart disease (excluding patent foramen ovale, atrial septal defect or ventricular septal defect with a defect size less than 2mm)
* other major congenital anomaly
* decision to withhold/withdraw care
Evaluating the Effects of Folic Acid Supplementation in Older Adults: The Folic Acid Supplementation Trial (The FAST Study)

High levels of homocysteine, which is an amino acid in the blood, have been linked to an increased risk of heart disease. This study will examine the effect that differing levels of folic acid have on reducing homocysteine levels among older adults.

Elevated levels of homocysteine may be a risk factor for coronary heart disease, stroke, and peripheral vascular disease. Folate is a type of B vitamin that occurs naturally in food. In nutritional supplements, folate is known as folic acid, and it has been shown to lower the concentration of homocysteine in blood. Folic acid supplements are a simple way for people to increase their folate intake, lower their homocysteine levels, and reduce their risk of developing heart disease. However, more research is required to determine the most effective dose of folic acid needed to lower homocysteine levels. The purpose of this study is to examine the effect that varying doses of folic acid have on folate levels and homocysteine concentration levels in older adults.

This 6-week study will enroll healthy adults over the age of 60 who do not currently take multivitamins or B-vitamins. At a screening visit, participants will complete questionnaires on medical history, demographics, and diet. Also, height and weight will be measured, and a blood collection will occur. At a baseline study visit, participants will be randomly assigned to receive either placebo or one of four doses of folic acid-100 mcg, 400 mcg, 1000 mcg, or 2000 mcg-to be taken once a day for 6 weeks. Participants will attend a final study visit at Week 6, at which time another blood collection will occur.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Living in the Baltimore area

Exclusion Criteria:

* Taking multivitamins or B-vitamins
* Unwilling to discontinue supplements for 8 weeks before study entry
* Use of intramuscular vitamin B12
* Seizure disorder
* Pernicious anemia
* Long-term use of anti-folate drugs (e.g., methotrexate, sulfa-antibiotics)
Study of Spino-pelvic Sagittal Balance by Vicon® Optoelectronic System

Spinal diseases often induce gait disorders with multifactorial origins such as lumbar pain, radicular pain, neurologic complications, or spinal deformities. However, radiography does not permit an analysis of spinal dynamics; therefore, sagittal balance dynamics during gait remain largely unexplored. This prospective and controlled study try to assess the Vicon system for detecting sagittal spinopelvic imbalance and to determine the modification induced by ant induced anterior sagittal imbalance on the kinetics walking parameters


Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* Aged between 20 to 40 years
* Height between 165 to 190 centimeters
* Asymptomatic subjects from spinal point of view
* BMI \< 30 kg/m²
* Affiliated to French Social Security
* Subjects having read the information note and signed informed consent

Exclusion Criteria:

* Subjects with neurological, vestibular, rheumatological or orthopedic pathology which can influence walking and balance
* Subjects with known spinal pathology
* Subjects with visible morphologic spinal deformity
* Subjects with significant visual impairment (visual acuity \< 6/10) despite an optical correction port
* Subjects unable to walk without help
* Person placed under the safeguard of justice, guardianship or curatorship
* Subjects involved in other biomedical research during this study
* Subjects presenting an asymptomatic spinal pathology discovered at the inclusion on the spinal EOS images.
Post Marketing Study to Evaluate the Two Dose Regimens of Nicardipine Injection in Hypertensive Emergency Patients

To compare the efficacy and safety of two dose adjustment regimens (i.e. weight-based and non-weight-based) for the treatment of Chinese hypertensive emergency patients.

This study is a prospective, multi-center, open-label, randomized and controlled study. Subjects are selected from hypertensive emergency patients with a BP (Blood Pressure) of \>180/120mmHg (SBP/DBP) and accompany with end target organ damage. All subjects are randomized into two groups receiving the Nicardipine Injection: Control Group (at a weight-based dose adjustment, i.e. according to the current Package Insert approved by SFDA) and Study Group (at a non-weight-based dose adjustment, i.e. according to the Package Insert approved by FDA).

Patients meet the inclusion/exclusion criteria are randomly allocated at 1:1 proportion to Control Group and Study Group. Before the treatment, investigators should define the target BP value for every subject according to different illness state, According to the BP, the dose of Nicardipine Injection is adjusted through different methods until reaching of target BP value. After reaching target BP value or 60min after the dosing initiation, BP and pulse rate are measured every 5\~15min for 2h. Two to six hours after dosing, BP should be controlled at 160/100\~110mmHg, and the maintenance dose is determined by the investigators according to the illness state.

Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure (SBP) ≥180mmHg and/or diastolic blood pressure (DBP) ≥120mmHg, and with the evidences or manifestations of end-organ damage (i.e. with any following hypertension emergency symptom: Chest pain, short breath, upper abdominal discomfort, syncope, vertigo, blurred vision, consciousness, hematuria or ischemic change under 12-lead ECG)
* Able to and voluntary to complete this study according to this study protocol, and sign the Informed Consent Form by himself/herself (or via his/her legal guardian)

Exclusion Criteria:

* Allergy to the Nicardipine Injection or its compositions
* Serious aortic valve stenosis
* Peri-operative hypertension
* Cerebral hemorrhage caused by the cerebrovascular malformation, hemangioma or cerebral infarction, cerebral hemorrhage into cerebral ventricle, and cerebral trauma with concomitant cerebral hemorrhage
* Other possible influencing factors for the safety or efficacy judgment in the investigators' opinions
Clinical Value of Left Atrial Appendage Flow for Prediction of Successful Catheter Ablation for Persistent Atrial Fibrillation

The purpose of this study was to determine whether left atrial appendage flow velocity, as determined using trans esophageal echocardiography (TEE), predicts the outcome after catheter ablation of persistent Atrial fibrillation( pAF).

40 PAF patients underwent 3D mapping and ablation. A stepwise approach including circumferential pulmonary vein (PV) isolation, continuous complex-fractionated electrogram (CFE) ablation and linear ablation was performed by the same operator. The procedural end point was termination of persistent AF by catheter ablation, either by conversion directly to sinus rhythm or to atrial tachycardia. Left atrial appendage (LAA) peak flow velocities were measured with transesophageal echography and averaged within each RR interval of 10 consecutive cardiac cycles.

Eligibility Criteria:
Inclusion Criteria:

* First-time radiofrequency catheter ablation for pAF. pAF was defined as continuous AF lasting longer than 1 month, resistant to either electrical or pharmacological cardioversion.
* Informed consent

Exclusion Criteria:

* Severe valvular disease requiring surgery
* Valvular prosthesis
* Known severe coronary artery disease
* Atrial and/or ventricular thrombosis
* New York Heart Association functional class III to IV
* Cerebrovascular disease
* Pulmonary embolism
* Latent or manifest hyperthyroidism
A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

The purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment on erythroid response in anemic subjects with low risk Myelodysplastic Syndrome (MDS).


Eligibility Criteria:
Eligibility Criteria: General: - Low risk MDS (low or intermediate-1 risk as defined by IPSS) and FAB classification of RA, RARS, or RAEB with blasts less than or equal to 10% determined via a bone marrow biopsy and CBC - Adequate iron stores determined by bone marrow film or section staining for iron via a bone marrow biopsy - ECOG Performance status score of 0, 1, or 2 Laboratory: - Local laboratory screening Hgb less than or equal to 11.0g/dL - Adequate renal function (serum creatinine concentration less than or equal to 2.0 mg/dL) - Adequate liver function (total bilirubin less than or equal to 2 times, ALT less than or equal to 3 times, and AST less than or equal to 3 times the upper limit of the respective normal range) Ethical: - Must be 18 years of age or older - Provide written Institutional Review Board (IRB)-approved informed consent before any screening procedures are performed
The Use of Doppler to Diagnose Myometrial Masses

Colour Doppler sonography has also been evaluated in differentiating adenomyosis from fibroids. Two dimensional color Doppler ultrasound revealed that 87% of adenomyosis cases had vessel distributions different from those found in leiomyoma cases, in addition to a high pulsatility index (PI) .Adenomyotic lesions had randomly scattered vessels or intratumoral signals while leiomyomas usually had peripheral scattered or outer feeding vessels.

Because it is more sensitive, less angle-dependent, and not susceptible to aliasing , power Doppler Sonography has the potential to detect fluctuations in blood flow , with results superior to those of frequency-based color Doppler sonography, particularly in situations of low-velocity blood flow. Three dimensional power Doppler ultrasonography can be applied to differentiate between uterine adenomyosis and leiomyoma ,and it may reduce the number of false positives by detailed investigations.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20 \& 60 years.
* Asymptomatic pts which discover the mass accidentally .
* Patients with symptoms like menorrhagia, menometrorrhagia, dysmenorrheal , abdominal masses.
* Patients scheduled for hysterectomy(abdominal/vaginal or Laparoscopic)
* Patients scheduled for myomectomy.

Exclusion Criteria:

* Pregnant patients
* Age over 60 or under 20years.
* Conservative management (Non surgical)
Wearable Sensor-based Balance Training for Patients With Knee Osteoarthritis

Knee osteoarthritis (KOA) is one of the leading causes of lower limb disability among the elderly and can cause loss of knee joint proprioception that contributes towards deterioration of postural balance. Maintaining a good postural stability is essential while performing everyday functional activities and to avoid falls. Exercise training has been reported to reduce pain as well as improve performance of functional tasks in patients with KOA however compliance to exercise can be challenging due to pain, lack of motivation and traditional nature of exercise that can easily overtax patients. Furthermore, there are not exercise programs that are specifically designed for patients with KOA in order to address lost knee joint proprioception. Recent studies have also demonstrated that visual feedback during exercise can enhance the benefits of exercise training. Therefore, the aim of the proposed study is to implement an interactive sensor-based exercise training to improve postural balance, gait and activities of daily living in patients with KOA.

The exercise intervention procedure is based on wearable sensor game-based balance-training program (Exergame). Subjects will perform progressive balance exercises such as ankle reaching or weight shifting, obstacle crossing, and ankle trail making task (i.e. motor-cognitive task). Real-time visual/audio lower-extremity joint motion feedback will be provided using wearable sensors (LEGSys, Biosensics LLC, Cambridge, MA, USA) to assist and encourage subjects to accurately execute each exercise task. The same wearable sensor technology is also used to quantify changes in balance and gait.

Changes in balance, gait, fear of falling, physical activity, pain, and quality of life parameters will be assessed at the beginning and conclusion of the training program.

Subjects will perform sensor-based interactive balance training (on computer screen), 2 x week, for a period of 6 weeks. The training consists of three balance tasks shown on a computer screen (1. ankle reaching task or weight shifting , 2. obstacle negotiation task, and 3. ankle trail making task (i.e. motor-cognitive task) intended to improve postural stability.

Eligibility Criteria:
Inclusion Criteria:

* age 18 and above
* ability to walk 50 m independently (with or without aid)
* ability to stand for 5 minutes .

Exclusion Criteria:

* disorder other than osteoarthritis that may severely affect gait and balance