cyrilzakka/clinical-trials huggingface dataset:
Clinical Study on Treatment of Neurogenic Bladder by Electroacupuncture on Ba Liao Point Under Ultrasound Guidance

To explore acupuncture under the premise of real-time, dynamic and accurate positioning of Ba liao point with ultrasound, observe the clinical efficacy of treating neurogenic bladder, clarify the essence of acupoints, and provide a new method for the standardization of acupuncture and moxibustion.


Eligibility Criteria:
Inclusion Criteria:

1. The diagnosis of neurogenic bladder conforms to the main points;
2. Symptoms and signs: patients with lower urinary tract dysfunction such as frequency of urination, urgency of urination, inadequacy of urine or retention of urine, urinary incontinence; Physical examination showed paresthesia in perineum and saddle area.
3. Auxiliary examination; Routine urine examination, B - ultrasonography of urinary system and urodynamic examination.
4. Indwelling catheter has been removed;
5. Conscious and able to accurately express symptoms and signs;
6. Patients who inform patients and their families of the research situation in detail and obtain their consent for treatment.

   -

Exclusion Criteria:

1. Lower urinary tract dysfunction caused by non-nervous system factors such as urethral calculi and organic obstruction;
2. patients with serious heart and lung diseases, liver and hematopoietic diseases and mental diseases;
3. patients with prostate cancer, urethral stricture, bladder neck fibrosis, interstitial cystitis, glandular cystitis and other diseases;
4. patients implanted with urethral stents or sacral nerve electrodes;
5. pregnant and lactation women;
6. Fear of acupuncture, needle-sickness and blood sickness. -
Chemoreflex Sensitivity in Chronic Kidney Disease

Cardiovascular morbidity and mortality are markedly increased in chronic kidney disease (CKD) and may be explained in part by sympathetic hyperactivity. Impaired hyperoxic chemoreflex sensitivity (CHRS) has been attributed to an increased sympathetic activity. The aim of the present study is to examine whether chemosensor function is altered in patients with stage 3 and stage 4 CKD.

Impaired hyperoxic chemoreflex sensitivity (CHRS) is assessed in patients with stage 3 CKD \[glomerular filtration rate (GFR) 30-59 ml/min/1.73 m2\], in patients with stage 4 CKD \[GFR 15-29 ml/min/1.73 m2\], as well as in patients without any evidence of CKD. CHRS is measured by determination of the venous partial pressure of oxygen and the heart rate before and after deactivation of the chemoreceptors by inhalation of pure oxygen. The difference in the R-R intervals before and after inhalation divided by the difference in the oxygen pressures is calculated as the CHRS. A CHRS below 3.0 ms/mmHg is defined as pathological. It should be shown that using a simple clinical bedside test we provide the first evidence for impaired hyperoxic chemoreflex sensitivity in stage 3 and 4 chronic kidney disease. We thereby may lay the basis for future intervention studies assessing chemosensor function in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from CDK stage 3 (GFR 30-59 ml/min/1.73 m²) or stage 4 (GFR 15-29 ml/min/1.73 m²)
* For the reference Patients without evidence for CDK

Exclusion Criteria:

* Patients with heart failure, history of myocardial infarction or instable angina pectoris, atrial fibrillation, hyperthyroidism, chronic pulmonary diseases, sleep apnoea syndrome, alcohol abuse and drug induced cardiomyopathy
Acute Effect of Continuous Positive Airway Pressure in Heart Failure

Acute effects of CPAP on diastolic function in patients with compensated heart failure (CHF) are unknown. The investigators hypothesized that acutely CPAP improves diastolic function, which is associated with increases exercise tolerance.

Objective: To evaluate the acute effects of CPAP on functional capacity and diastolic indices of patients with CHF. This is a randomized trial including 44 patients with compensated heart failure (functional classes II or III, NYHA). Patients will be allocated in CPAP(CPAP with 10cmH2O) or simulated CPAP (null pressure) after computed randomization, in a 1:1 ratio. All subjects shall complete a 6-minute walk test (6MWT) before and after CPAP (30 minutes; 10 cm H2O pressure). Doppler-echocardiogram will be performed before and at the end of CPAP. Wilcoxon or paired t tests were used to compare results, with significance level at p \< 0.05.


Eligibility Criteria:
Inclusion Criteria:

* functional class II or III (NYHA)heart failure
* agreement to participate in the study
* absence of acute exacerbation of dyspnea
* intact upper airway

Exclusion Criteria:

* valvular heart disease
* chest pain or unstable angina
* acute myocardial infarction in the prior month
* uncontrolled hypertension
* atrial fibrillation or other arrhythmias
* acute infection
* orthopedic limitations
* intolerance to CPAP mask
Insulin Glulisine Administered Pre-meal Versus Post-meal in Adult Subjects With Type 2 Diabetes Mellitus Receiving Insulin Glargine as Basal Insulin

The purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (Apidra) versus post-meal Apidra, in patients receiving insulin glargine (Lantus) as basal insulin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus for at least six months
* 18 to 70 years of age, inclusive
* A1c ≥ 7.5% and ≤ 10%
* At least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2 injections per day) +/- metformin prior to study entry
* Negative glutamic acid decarboxylase (GAD) autoantibodies
* Ability and willingness to perform self-monitoring of blood glucose (SMBG) at least four times a day, and at least 7 times daily during the 7-point blood glucose (BG) profile measurement days
* Ability and willingness to adhere to, and be compliant with, the study protocol
* Must be able to read English or Spanish at the sixth grade level in order to complete the patient-reported outcomes component of the study
* Signed informed consent

Exclusion Criteria:

* Subjects treated with sulfonylureas, thiazolidinediones (TZDs), or any other oral antidiabetic drugs (at study entry) except for insulin and/or insulin analogues with or without metformin
* Planned pregnancy; or pregnant or lactating females
* For subjects treated with metformin: serum creatinine ≥ 1.5 mg/dL (133 µmol/L) for males or ≥ 1.4 mg/dL (124 µmol/L) for females
* Serum creatinine ≥ 3.0 mg/dL (266 µmol/L)
* Any clinically significant renal disease (other than proteinuria) or hepatic disease
* Serum ALT or AST levels greater than 2.5 X the upper limit of normal
* Any current malignancy or any cancer within the past 5 years (except for adequately treated basal cell skin cancer or cervical carcinoma in situ)
* Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Diagnosis of impaired dexterity or vision rendering the subject unable to administer multiple daily injections (MDIs)
* Cardiac status New York Heart Association (NYHA) III-IV
* Hypersensitivity to Lantus or Apidra or any of their components
* Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that, in the opinion of the investigator or sponsor, may interfere with the completion of the study.
* Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
* Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
To Evaluate the Pharmacokinetic of Diacerein and Rhein After Maximum Use in Patients With Epidermolysis Bullosa (EB)

A pharmacokinetic (PK) study in 16-20 EB subjects to be allocated to two cohorts. Cohort 1 to include 8-10 subjects (ages 12 yrs and older); Cohort 2 to include 8-10 subjects (ages 6 months-11 yrs, inclusive). Cohort 2 only included subjects 4 yrs and older. Serial PK blood sampling collected on Days 1 and 10. Analyses were performed to determine the concentrations of diacerein and rhein.

This was an open-label, single-period study that intended to include subjects with EB consisting of infants/ children (ages 6 months to 11 years, inclusive) and adolescents/ adults (ages 12 years and older). The study included 2 cohorts.

Cohort 1 was to include adolescent/adult subjects with EB (ages 12 years and older);

Cohort 2 was to include infants/children with EB (ages 4 to 11 years, inclusive).

For both cohorts, the study intended to enroll subjects with epidermolysis bullosa simplex (EBS), dystrophic epidermolysis bullosa (DEB), and junctional epidermolysis bullosa (JEB) with lesions encompassing \>/=2% BSA. The diacerein application area was \>/=5% BSA and included lesioned and non-lesioned skin (if lesions accounted for \<5% BSA); however, topical administration was \</=30% BSA. On Days 1 and 10, the topical dose of study drug was applied by study staff, and blood was sampled for PK analyses of diacerein and rhein pre-dose and through 8 hours post-application. On Days 2 to 9, study drug was applied to the application area(s) at home. For Cohort 1, trough PK samples were collected on any 2 available days from Days 3 through 9, and study drug was applied after blood draw, while for Cohort 2 trough PK analyses were not performed.

Eligibility Criteria:
Key Inclusion Criteria:

* At least 12 years of age (Cohort 1) or at least 6 months of age to 11 years, inclusive (Cohort 2) at screening. For US only: at least 4 years of age to 11 years, inclusive (Cohort 2)
* The subject must weigh at least 9 kg (19.8 lbs) at Screening.
* Subject has a documented genetic mutation consistent with EB.
* Subject has EB lesions on ≥ 2% body surface area (BSA) and the EB lesions are in the following body areas: a. Localized: plantar and/or palmar areas, b. Generalized: arms, legs, torso, hands and feet.

Key Exclusion Criteria:

* Subject has EB lesions where drug will be applied that are infected
* Subject has used any diacerein containing product within 1 month prior to Visit 1
* Subject has used systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to dosing.
* Subject has used systemic steroidal therapy or has used topical steroidal therapy on the EB lesions in the application area within 14 days prior to dosing
* Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to dosing
Donating Oral Mucosal Cells for the Study of ex Vivo Culture of Cells Sheets

Cultivated oral mucosal epithelial sheets on amniotic membrane have been reported to have good clinical results in treating patients with ocular surface disorders in both human and animal studies. However, such technique has not been well established in this hospital. The main purpose of this study is to obtain the discarded oral mucosal tissue from healthy donors who volunteer to donate their oral mucosa from buccal area. The obtained oral mucosal tissue will be cultured under different types (co-culture with or without 3T3 cells)。Inverted light microscopy, electron microscopy and immunostaining with K3/K12, K14, Ki67, P63, connexin 43, and involucrin will be preformed to test the effects of foreskin cell line co-culture system on cell condition. The investigators plan to start the study from Jan. 1st, 2011 to Dec. 31th, 2015. Thirty patients will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* The age 20 to 55 year-old healthy contributor.
* does not have disease of the oral cavity.

Exclusion Criteria:

* In the past had the oral mucosa disease, wound cicatrization bad, or hemoglutination condition not good medical history. Sickness must stop using above any anti-hemoglutination medicine one week.
A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children

This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine.

This study will also evaluate the immunogenicity and safety of the investigational vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they and/or their parent(s) or legally acceptable representative(s) can and will comply with the requirements of the protocol.
* A male or female child aged between 3 and 8 years inclusive at the time of the first vaccination; children are eligible regardless of history of administration of influenza vaccine in a previous season. However, subjects who have received any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine will not be enrolled.
* Written informed consent obtained from the subject/from the parent(s)/legally acceptable representative(s) of the subject.
* Written assent obtained from the subject if/as required by local regulations.
* Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
* Access to a consistent means of telephone contact

Exclusion Criteria:

* Child in care.
* Use of an investigational or non-registered product other than the study vaccines within 30 days before study vaccination or planned use during study period. Routine registered childhood vaccinations are permitted.
* Prior receipt of any seasonal or pandemic influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. Prior receipt of more than one dose of a licensed hepatitis A vaccine, with the first dose administered at \>=12 months of age.
* Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.
* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
* History of Guillain-Barre syndrome within 6 weeks of receipt of prior influenza virus vaccine.
* Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to constituent of vaccine; or a history of severe adverse reaction to a previous influenza vaccine.
* Fever at the time of enrolment.
* Acute disease at the time of enrolment.
* Any significant disorder of coagulation or treatment with Coumadin derivatives or heparin.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Ongoing aspirin therapy.
* Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
The Appropriate Anticoagulation Duration for Chronic Obstructive Pulmonary Disease With Pulmonary Thromboembolism

Anticoagulation is the most important treatment for pulmonary thromboembolism (PTE). The thromboembolism risk is especially high in patients with chronic obstructive pulmonary disease (COPD) exacerbations. However, there's no agreement on the most appropriate duration of anticoagulation in COPD with PTE to balance the risk of recurrence of thrombosis and bleeding. This randomized, controlled trial aims to evaluate the risk and benefit of prolonged anticoagulation compared with the regular 3-month anticoagulation in COPD with PTE.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients due to chronic obstructive pulmonary disease exacerbation and diagnosed as newly developed pulmonary thromboembolism
* Regular anticoagulation for 3 months and got CT pulmonary angiography

Exclusion Criteria:

* Patients with major bleeding during prior anticoagulation
* Patients need long term anticoagulation to treat other diseases
* Patients unwilling to receive prolonged anticoagulation
Cardiac Arrhythmia in Patients with End-Stage Renal Disease

The study will examine the presence of cardiac arrhythmias in patients receiving hemodialysis and the role of diabetes, hypoglycemia and parameters related to uremia and the dialysis procedure.

The study is designed as a prospective cohort study with 18 months follow-up. 70 patients receiving chronic hemodialysis will be recruited and equipped with implantable loop recorders (ILR): 35 patients with diabetes and 35 patients without diabetes.

Data collection during the follow-up includes continuous monitoring of the heart rhythm by the ILR for the entire follow-up period, continuous glucose monitoring for 10 days every second month, and monthly collection of blood samples and dialytic parameters.

After the initial 18-month follow-up, heart rhythm monitoring will continue until the ILR battery runs out for those participants who wish to continue.


Eligibility Criteria:
Inclusion Criteria:

Patients with diabetes:

* Type 1 diabetes or Type 2 diabetes diagnosed according to the criteria of the World Health Organization
* Treated with glucose-lowering drugs at inclusion
* Receiving in-center maintenance hemodialysis for more than 3 months
* Age ≥ 18 years

Patients without diabetes:

* No known diagnosis of diabetes
* No previous treatment with glucose-lowering drugs
* HbA1c \< 48 mmol/mol at screening
* Receiving in-center maintenance hemodialysis for more than 3 months
* Age ≥ 18 years

Exclusion Criteria:

For both groups:

* Cardiac pacemaker or implantable cardioverter defibrillator (ICD)
* Known permanent (chronic) atrial fibrillation
* History of sustained (\> 30 seconds) ventricular tachycardia (more than 200 bpm) or ventricular fibrillation (note that ventricular premature beats is not considered an exclusion criterion)
* Known cardiac ion-channel disease (such as Long QT syndrome and Brugada syndrome)
* Not suitable for implantation (left-sided dialysis catheter or other condition expected to interfere with implantation)
* Previously complications in relation to wearing a CGM sensor, e.g. allergic reaction
* Inability to give written informed consent
Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations

Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either Rasagiline or Placebo


Eligibility Criteria:
Inclusion Criteria:

Men and women with idiopathic Parkinson's disease whose diagnosis is confirmed by at least two of the cardinal signs (resting tremor, bradykinesia, rigidity) being present, without any other known or suspected cause of parkinsonism.

Subjects must experience levodopa related motor fluctuations averaging at least 2.5 hours daily in the OFF state.

Subjects must be taking optimized levodopa/carbidopa or levodopa /benserazide carbidopa/levodopa therapy (based on investigator's judgment), stable for at least 14 days prior to baseline. Subjects must be receiving at least 3 daily doses of levodopa, not including a bedtime dose.

Selegiline must be discontinued for at least 90 days prior to baseline.

Subject must be age 30 or older.

Subjects must be willing and able to give informed consent.

Exclusion Criteria:

Subjects with a clinically significant or unstable medical or surgical condition which would preclude safe and complete study participation. Such conditions may include cardiovascular, pulmonary, hepatic, renal, or metabolic diseases or malignancies as determined by medical history, physical exam, laboratory tests, chest x-ray, or ECG for Parkinson's disease \[e.g., pallidotomy, thalamotomy, and deep brain stimulation (DBS)\] within the 12 months preceding the Baseline visit.

Subjects who have undergone neurosurgical transplantation are excluded regardless of when the procedure(s) was performed. No programming changes are permitted in subjects who have undergone DBS.

Participation in a previous clinical trial of rasagiline. Concomitant therapy with MAO inhibitors, reserpine, methyldopa within the past three months, or treatment with an anti-emetic or neuroleptic medication with central dopamine antagonist activity with the past six months.
Changes in Cerebral Oxygenation and Cognitive Functions

The present study aimed to assess the influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and postoperative cognitive function in patients undergoing nasal surgery.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* patients with ASA physical status of I-II
* aged 18-65 years

Exclusion Criteria:

* Age under 18 or above 65
* ASA \> II
* coagulation disorders
* history of cardiovascular and cerebrovascular disease
* poor Blood Pressure control
* anemia, pregnancy, addiction to opioids
* body mass index (BMI) \> 35
* intraoperative systolic BP \< 65 mmHg
* surgical duration less than 30 minutes or more than 160 minutes
* need for an intraoperative sympathomimetic drug and the use of other hypotensive drugs
* preoperative Mini-Mental State Examination (MMSE) score of 23 or less.
Comparative Study for the Optimal Treatment Method of Lateral Epicondylosis

The purpose of this study is to find the optimal treatment method for chronic lateral epicondylosis, and focused on the 'healing mechanism' and 'pain modulation' of degenerated tendon.The hypothesis is that there will be significant difference between treatment groups and control group (physiotherapy) and also there will be significant difference among treatment groups.

231 patients were randomized using a Random Sequence Generator (Random.org) into 4 groups: Group A (physiotherapy as a control, n=58), Group B (ESWT, n=62), Group C (Prolotherapy, n=56) and Group D (PRP, n=55). In group A, patients were educated to do stretching and eccentric strengthening exercise of wrist extensor muscles. In group B patients were treated with 3 sessions of high-energy shock wave therapy ESWT (Evotron, Switech medical, Kreuzlingen, CH) in 2 weeks interval. Total energy flux density ranged from 0.1 to 0.14 mJ/mm2 (1500 impulses). Shockwave was targeted over lateral epicondyle where maximum tenderness was located. In group C, injection of 20% dextrose (3cc mixed with 0.3cc of lidocaine) to ECRB tendon was done under ultrasound guidance and in group D, 3 cc of PRP (Harvest SmartPReP 2 APC 30 Process Kit, Harvest Technologies, Plymouth, MA) was injected into ECRB tendon under ultrasound guidance. 22G needle was used for injection in group C and D. The primary outcome measure is DASH scoring system which is recorded on the initial, 3rd, 6th, 18th and 24th month. Secondary outcome measures were ultrasonography (measured on initial, 6th and 24th month) and SSS (Subjective Satisfaction Score) measured on initial and 24th month. After 24 months from the last procedure, all serial questionnaires and physician-filled-SSS sheets were gathered and analyzed by a one-way analysis of variance and Scheffe post-test. A value of p\<0.01 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* 35 to 80 years of age
* history of elbow pain in the region of the lateral epicondyle for more than 6 months
* more than 3 months of treatment for lateral epicondylosis before enrollment in the study with no subjective improvement
* pain on resisted extension of wrist
* local tenderness to palpation at the lateral epicondyle
* confirmed as lateral epicondylosis on ultrasound imaging

Exclusion Criteria:

* history of steroid or botulinum injection(s) within 6 months before study enrollment
* other elbow pathology including nerve compression, previous elbow fracture, limited elbow range of motion, abnormal simple radiographic findings, history of elbow surgery and inflammatory arthropathies
* upper extremity pain or discomforts from shoulder or wrist or hand