cyrilzakka/clinical-trials huggingface dataset:
Observational Study of iv Ibandronate in Women With Postmenopausal Osteoporosis

This observational study assess the safety of intravenous Ibandronate (Bonviva) intermittent administration in patients with postmenopausal osteoporosis and the efficacy of IV Ibandronate (Bonviva treatment through relative lumbar spine and hip bone mineral densitometry form baseline at year 1)


Eligibility Criteria:
Inclusion Criteria:

* Patients had post menopausal osteoporosis
* Patients had no contraindication for bisphosphonates
* Patients had been naive for ibandronate therapy
* Patients who have signed informed consent and are willing to share their data for data analysis

Exclusion Criteria:

* Is not Ibandronate naïve
* Hypersensitivity to any component of the bisphosphonates Ibandronate;
* Administration of any investigational drug within 30 days preceding the first dose of the study drug.
First-pass Recanalization With EmboTrap II in Acute Ischemic Stroke (FREE-AIS)

This study is a prospective, open-label, multi-center, registry study, designed to to documents that EmboTrap II usage as a thrombectomy device for emergency large vessel occlusion (ELVO) in terms of the rate of First Pass Recanalization (FPR). Patients with ELVO will initially underwent mechanical thrombectomy usig EmboTrap II. FPR is defined as modified Tissue Thrombolysis In Cerebral Ischemia (mTICI) 2b or 3


Eligibility Criteria:
Inclusion Criteria:

1. Subjects experiencing acute ischemic stroke due to large vessel occlusion (intracranial internal carotid artery and middle cerebral artery M1 or proximal M2 segment, intracranial vertebral artery and basilar artery
2. Age 19 or greater
3. mRS before qualifying stroke, 0 to 2
4. Baseline NIHSS score 4 or more
5. CT ASPECTS \> 5 or MR ASPECTS \> 4
6. Good collateral statues on CT angiogram (collateral grade by Calgary group, 4 or 5) or corresponding to DEFUSE 3 or DAWN trial on perfusion imaging.
7. Onset (last-seen-well) time to femoral puncture time \< 24 hours
8. Anticipated life expectancy of at least 12 months
9. Patients who undergo endovascular thrombectomy with EmboTrap II as the first-line device
10. Signed informed consent for study enrollment

Exclusion Criteria:

1. Multiple simultaneous large vessel occlusions
2. Pregnancy
3. Severe contrast allergy or absolute contraindication to iodinated contrast agent
4. Patient has a severe or fatal combined illness that will prevent improvement of follow-up or will render the procedure unlikely to benefit the patient.
Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Spain.


Eligibility Criteria:
Inclusion Criteria:

* Healthy 2-month-old infants
* Available for the entire study period

Exclusion criteria:

* Previous vaccination with any vaccine before the start of the study
* Known contraindication to vaccination
Comparison of Gastric Bypass and Sleeve Gastrectomy in Metabolic and Cardiovascular Indices

Morbidly obese patients undergoing either Roux en Y gastric bypass or sleeve gastrectomy were examined preoperatively, 3, 6, and 12 months after surgery. On each occasion, anthropometric data were collected, resting metabolic rate was measured, and the patients underwent a panel of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart ultrasound). Following that, they consumed a test meal and completed visual analog scales for the subjective assessment of hunger and fullness every 30 minutes for 3 hours. At the same time points, blood samples were collected for the consequent measurement of glucose, insulin, lipids, and gastrointestinal hormones.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>40 kg/m2
* Age between 18 and 65 years
* Proven failure to lose weight through non-surgical interventions

Exclusion Criteria:

* Serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy)
* Patients' inability to adhere to postsurgical instructions
* Alcohol or other substance abuse
* Concurrent psychiatric illness
Intact Liver Innervation and Glucose and Glucagon-like Peptide-1 (GLP-1) Induced Insulin Secretion

The aim of the study is to investigate the significance of intact nerve supply to the liver for the glucagon-like peptide-1 (GLP-1) induced insulin secretion.

The hypothesis is that the effects of GLP-1 is transmitted through the GLP-1 receptor and that these effects involve sensory afferent neurons, probably primarily parasympathetic.

GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers.

The aim of this study is to investigate the significance of intact liver innervation for the GLP-1 induced insulin secretion in liver transplanted patients; kidney transplanted control patients matched for immunosuppressive treatment, age, gender and body weight; and ten control persons matched for age, gender and body weight.

The insulin secretion will be evaluated from blood samples that will be analyzed for insulin and c-peptide.

Eligibility Criteria:
Inclusion Criteria:

* normal fasting plasma glucose
* normal hemoglobin
* informed consent

Exclusion Criteria:

* type 1 diabetes mellitus or type 2 diabetes mellitus
* body mass index \> 30
* inflammatory bowel disease
* intestinal surgery
* serum creatinine \> 250 µM and/or albuminuria
* ALAT \> 2 x normal value
* Severe cardiac insufficiency
* in treatment with medicine which cannot be paused for 12 hours
Clinical Study to Evaluate the Safety and Efficacy of Heating and Cooling Combination Therapeutic Device(OCH-S100)

The purpose of this study is to verify the efficacy and safety of heating and cooling combination therapeutic device (OCH-S100) for patients with chronic low back pain (LBP).

The investigators targeted the patients with chronic LBP. After treatment in 2 groups - real heating and cooling combination treatment and sham heating and cooling combination treatment - the investigators will compare the effects of pain relief and improvement in disability and range of motion of lumbar region. So the investigators will confirm the efficacy of heating and cooling combination therapy, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. At least 20 years of age, but below 75 years of age
2. Low back pain in the last 3 months or more
3. Low back pain rated over 40 mm on a 100 mm Visual Analog Scale (VAS)
4. Those who are reliable and willing to cooperate in this test, and obey the restrictions for the treatment period.
5. An understanding of the objectives, methods and efficacy of the clinical trial, and willingness in completing the consent form.

Exclusion Criteria:

1. Trauma to or surgery on the lumbar region within 6 months prior to enrollment
2. Low back pain accompanied by sciatica
3. Systematic disease, and severe dysfunction due to the medical illness (e.g. cancer, infection, etc.)
4. A history of medication, oriental medical treatment, physiotherapy for treating low back pain within the last 4 weeks
5. Neurological disease, such as topical or whole body hypoesthesia in temperature sensation (e.g. stroke, peripheral neuropathy, etc.)
6. Hypersensitivity in heating and cooling stimulation
7. Pregnant and lactating women
8. Participate in the other clinical trials within the last 3 months or after enroll this trial
9. When researchers evaluate that it is not appropriate to participate in this clinical test
Whether Patients With Achilles Tendon Tears Have Different Lipid Levels Than Healthy People: a Retrospective Study

To explore the difference of blood lipid levels between patients with Achilles tendon rupture and healthy people without Achilles tendon rupture, and to provide clues for further exploration of its mechanism.

Data were collected from 287 patients with Achilles tendon rupture repaired by Yang Yuping, deputy chief physician of the Institute of Sports Medicine of Peking University Third Hospital from January 2017 to December 2017. A total of 10,375 subjects who underwent physical examination in the Physical Examination Center of Peking University Third Hospital during the same period were selected as the control group, and 9,193 subjects were selected as the control group after excluding patients without blood lipid test results, professional athletes, hypertension and diabetes patients. The general data, blood glucose, blood lipid, blood uric acid, smoking and alcohol consumption of the subjects were collected through the hospital information system. The blood glucose, blood lipid, uric acid and other data of the control group and the Achilles tendon rupture group were detected, and it was concluded that the blood lipid level of the patients with Achilles tendon rupture group was higher than that of the control group.

Eligibility Criteria:
Inclusion Criteria:

* Rupture of Achilles tendon repair surgery experience

Exclusion Criteria:

* hypertension
* diabetes
* Professional athlete
* No blood lipid test results
Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients

This is an interventional randomized ope-label two-arm trial on the peri-operative use of immunonutrition in Crohn's Disease (CD) patients undergoing colorectal elective surgery.The aim of the trial is to assess the effectiveness of immunonutrition therapy in decreasing the rate of post-operative infective complications and 6 months endoscopic disease recurrence.

Crohn's Disease (CD) patients undergoing abdominal surgery are at high risk to develop post-operative surgical and medical infective complications. Infective complications affect almost 24% of patients. Post-surgical disease recurrence afflicts 35-85% of CD patients in the first year after surgery. Immunonutrition has been successfully applied to surgical patients in several randomized trials, demonstrating a decreased rate of post-operative infective complications. The aim of the study is to compare the incidence of surgical and medical post-operative infective complications and six months endoscopic and clinical disease recurrence (DR) in CD patients receiving immunonutrition in the peri-operative setting compared to patients treated as for standard of care.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years old, females or males;
* Established Crohn's Disease at the time of surgery indication;
* Patients scheduled for elective open or minimally invasive bowel resection or strictureplasty;
* Patients planned for concomitant perianal surgery for CD-related perianal disease can be included in the study.

Exclusion Criteria:

* Patients \< 18 years old;
* Pregnant or breastfeeding women;
* Diagnosis of undetermined colitis;
* Concomitant diagnosis of malignancy;
* Established malnutrition, according to clinical definition, requiring nutritional intervention;
* Patients with more than two criteria for high risk of recurrence among the following: previous abdominal resection, penetrating disease phenotype or active smoking;
* Any condition that, in the opinion of the investigator, can interfere with the consent procedure or the conduction of the trial;
* Patients known to have allergic history to any component of the investigational product;
* Patient with liver and kidney dysfunction (alanine aminotransferase ALT ≥ 2 times the upper limit of normal; total bilirubin TBIL ≥ 2 times the upper limit of normal; creatinine Cr ≥ 2 times the upper limit of normal);
* Patients diagnosed with diabetes or fasting blood glucose≥ 10mmol/L;
* Planned recovery shorter than 48 hours;
* Surgery in emergency setting;
* Any concomitant surgery not related to CD or perianal CD.
Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise

Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care Unit (PICU) stays. NIRS estimates the amount of oxygen in tissues by comparing the tissue's absorption of two wavelengths of light corresponding to hemoglobin carrying oxygen and hemoglobin without oxygen.

During cardiac surgery, multi-site NIRS monitoring is used to determine the heart's output by comparing the amount of oxygen available to discrete regions of the body nourished by different parts of the circulatory system. NIRS leads placed on the forehead detect oxygen available to the brain (cerebral), while leads placed over the kidney reflect oxygen available to the internal organs (somatic).

NIRS monitoring has been used for studying muscle oxygen usage during exercise in normal and disease states. Cerebral oxygenation at peak exercise at has been studied with NIRS monitoring. The use of multi-site NIRS monitoring during exercise stress testing for studying cardiac output through the patterning of somatic and cerebral oxygenation in combination with exercise stress test data has not been researched.

We hypothesize that addition of multi-site NIRS monitoring to the standard data collection already achieved during exercise testing, will enable calculation of anaerobic threshold and cardiac output prediction. This will assist in determining appropriate timing for surgical intervention, predicting the post operative course and testing response to medication.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents from age 6 to 20 undergoing exercise stress testing on treadmill

Exclusion Criteria:

* Children and adolescents unable to exercise or unable to follow directions or unable to understand English.
INtravesical Antimicrobial Agents v STANDard Oral Antibiotics for the Treatment of Acute UTI in Women With rUTI

Women have problems with oral antibiotics, including vagina and bowel infections. Also, bacteria causing urinary infections are becoming more resistant to oral antibiotis. Placement of antibiotic directly into the bladder does not cause these problems and are at doses that are may be able to stop bacteria from being resistant to antibiotics.

Each participant once enrolled returns with an active Urinary Tract Infection (UTI), confirmed by urine void. Participants will complete an UTI questionnaire, and if consistent with a simple non-febrile UTI will be randomized to one of two arms: oral nitrofurantoin treatment for 7 days, or intravesical gentamicin instillation once a day for three days. Patients will be followed for symptom relief with a repeat voided urine in 7 to 10 days, and with a repeated questionnaire for symptom relief.

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

* Patients who report that they are pregnant.
* Patients with a positive urine pregnancy test
* Patients with a history of renal transplantation.
* Patients with bladder augmentation procedures using bowel.
* Patients with poorly controlled Type II diabetes, Hgb A1C \>6.5%
* Patients with spinal cord injury, ASIA Impairment Scale of C or higher.
* Patients with pelvic surgery within 6 months.
* Patients with urologic procedure within 6 months.
* Patients with a history of reconstructive urologic surgery, such as reflux, congenital abnormality.
* Immunocompromised patients being treated for malignancy or a history of actively treated malignancy within 5 years.
* Patients with active systemic autoimmune disease.
* Patients on systemic immunosuppression.
* Use of antibiotic prophylaxis within 6 months
* Use of antibiotics within 10 days of active infection
* Allergy/sensitivity to gentamicin or nitrofurantoin.
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual to give written informed consent.
Influence of Pantoprazole on the Pharmacokinetics of Fradafiban After Multiple Oral Doses of Lefradafiban Over 5 Days in Healthy Subjects

To assess the absorption of 30 mg Lefradafiban in two formulations, each under physiological conditions and with 40 mg Pantoprazole


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age ≥ 18 and ≤ 60 years, planned stratification: age \< 40 years (4 subjects) and ≥ 40 years (8 subjects)
* Broca ≥ - 20 % and ≤ + 20 %

Exclusion Criteria:

* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Participation in another trial with an investigational drug within 2 months prior to administration or during the trial
* Drug abuse
* Alcohol abuse (\> 60 g/day)
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Excessive physical activities within 5 days prior to administration or during the trial
* Blood donation within 1 month prior to administration or during the trial
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
* Chronic or relevant acute infections
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* History of

  * Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * Any bleeding disorder including prolonged or habitual bleeding
  * Other hematologic disease
  * Cerebral bleeding (e.g. after a car accident
* Recent surgical procedures
* Thrombocytes \< 150000/µ
* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Any laboratory value outside the clinically accepted reference range
* Other disease or abnormality of clinical relevance
Development and Pathological Changes of High Myopia Among Children and Adolescents in China

The study aims to observe the relationship between the changes of ocular structure parameters and pathological changes among children and adolescents with high myopia. Environmental factors and family history will also be collected to explore their impacts on high myopia progression.

This study aims to observe children and adolescents with high myopia for 3 years, and to collect data of ocular pathological changes, family history and environmental factors so as to understand the natural course and internal laws of the development of high myopia.

Eligibility Criteria:
Inclusion Criteria:

* 9 to 18 years old school students in Guangzhou, with either eye had myopia equal or greater than 6.0D
* Or 6 to 8 years old school students in Guangzhou, with either eye had myopia equal or greater than 3.0D
* Written informed consent for study participation
* Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

Exclusion Criteria:

* None school students in Guangzhou
* Other contraindications
* A history of allergy to tropicamide or topical anesthetics
* Missing ability to give informed consent
Effect of Liraglutide in Obese Women With Polycystic Ovary Syndrome

The aim of this study is to compare the hormonal, metabolic and clinical effects of metformin and liraglutide in infertile women with PCOs.

It is a Prospective randomized controlled trial .The study will include 80 randomly selected infertile women aged between 18 and 45 years, from Gynecology and obstetrics department Beni-Suef University Hospital whom diagnosed with polycystic ovarian syndrome (PCOS), The study will include two groups; each group consists of 40 patients:-

* Group1 (n=40) will be treated by liraglutide monotherapy.
* Group 2 (n=40) will be treated by metformin monotherapy.
* Group 3 (n=40) will be a control group.

To assess the metabolic effect of each treatment, the following parameters will be assessed before and after the treatment

* To assess the hormonal effect of each treatment, the following tests will be assessed before and after treatment
* Total Testosterone (TT)
* Dehydroepiandrosterone (DHEA)

To assess the clinical effect of the drugs, the following will be assessed before and after treatment:

The number of medium size follicles and large size follicles and the endometrium thickness were assessed on the tenth or eleventh day of menstruation. The chemical and clinical pregnancy rates were evaluated

Eligibility Criteria:
Inclusion Criteria:

* aged between 20 and 45 years
* PCO

Exclusion Criteria:

1. congenital adrenal hyperplasia
2. poorly controlled thyroid disease
3. Taking antidiabetic drugs which can affect insulin resistance
4. chronic kidney disease and history of recurrent urinary tract infections
5. liver dysfunction
6. documented use of oral hormonal contraceptives and hormone-releasing implants
Effects of Linagliptin on Active GLP-1 Concentrations in Subjects With Renal Impairment

This is a bi-centric, prospective, open study comparing the effects of linagliptin on active GLP-1 concentrations in subjects with renal impairment compared to subjects with normal renal function.


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 diabetes mellitus based on the disease diagnostic criteria (WHO) classification

Exclusion Criteria:

* Subjects with type 1 diabetes, maturity onset diabetes of the young (MODY) or secondary forms of diabetes such as due to pancreatitis.
A Study of Dovitinib Versus Sorafenib in Adult Patients With Hepatocellular Carcinoma (HCC) as a First Line Treatment

The purpose of this open-label, randomized, phase II study is to compare the safety and efficacy of dovitinib versus sorafenib as first-line treatment in adult patients with advanced Hepatocellular Carcinoma (HCC). This trial will be opened in countries of the Asia-Pacific region.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of advanced Hepatocellular Carcinoma (HCC) according to the AASLD Guidelines

* Advance HCC Stage B and C according to BCLC staging classification
* Child Pugh A
* At least one measurable lesion as assessed by CT or MRI
* ECOG PS of 0 or 1
* Adequate bone marrow, liver, and renal function

Exclusion Criteria:

* Prior systemic therapy for HCC
* Brain metastases
* Active bleeding (including variceal bleeding as the result of esophageal varices) Patients who have received a liver transplant or are awaiting an immediate transplant

Other protocol-defined inclusion/exclusion criteria may apply