cyrilzakka/clinical-trials huggingface dataset:
Efficacy in Controlling Glycaemia With Victoza® (Liraglutide) as add-on to Metformin vs. OADs as add-on to Metformin After up to 104 Weeks of Treatment in Subjects With Type 2 Diabetes

This trial is conducted globally. The aim of the trial is to investigate efficacy in controlling glycaemia with Victoza® (liraglutide) as add-on to metformin background treatment vs. OADs as add-on to metformin background treatment for 104 weeks of treatment in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria: - Male or female at least 18 years of age at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes equal to or above 90 days prior to the screening visit - Stable daily dose of metformin as monotherapy equal to or above 1500 mg or maximum tolerated dose within 60 days prior to the screening visit - HbA1c 7.5-9.0% (59-75 mmol/mol) (both inclusive) and measured within the last 90 days prior to the screening visit Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) - Treatment with any medication for the indication of diabetes other than metformin in a period of 60 days before the screening visit. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with intercurrent illness - Receipt of any investigational medicinal product within 30 days before the screening visit - Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses

The purpose of this study is to develop an Auditory Brainstem Response (ABR) based neurological screening method to detect increased risk for Autism Spectrum Disorders (ASD) and other neurological conditions in newborns.

In the proposed study, a screening method for neurological deficits, with an emphasis on its application to ASD, will be developed and its feasibility demonstrated. The proposed method will utilize high rate stimulation to acquire Auditory Brainstem Responses in order to determine peak latency and amplitude differences in children with ASD compared to non-ASD. Similarly to newborn hearing screening, the output of the screening method will provide an automated pass or refer outcome that can be used by a physician to determine if the child needs further evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Children with autism spectrum disorder diagnosis
* Normally developing age- and gender-matched controls

Exclusion Criteria:

* Permanent or temporary hearing loss at the time of testing.
* Craniofacial abnormalities
Microbiomes in Patients of Recurrent Common Bile Duct Stones

Bile duct stones is a common biliary tract disease, which is characterized by high morbidity and frequent recurrence. Endoscopic retrograde cholangiopancreatography (ERCP) is an effective therapy for common bile duct stones, and endoscopic sphincterotomy (EST) which associated with recurrent cholangiolithiasis often carried out on difficult intubation or extracting stones, probably due to enhanced reflux of intestinal contents that changes the microenvironment. Patients with cholangiolithiasis were consecutively recruited and their bile was collected intra-operatively for high-throughput experiments. Pyrosequencing of 16S ribosomal RNA gene was performed to characterize the microbiota in the bile and other body fluids. A liquid chromatography mass spectrometry-based method was used to profile bile composition. Clinical manifestation, microbiome, and bile composition were compared between patients with or without recurrent of bile duct stones. The aim of our study was to identify the impact of microbiomes on the recurrent of bile duct stones after ERCP+EST therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with recurrent common bile duct stones.
2. No antibiotics or probiotics are used for nearly three months.
3. In addition to common bile duct stones, possibly without other digestive diseases.

Exclusion Criteria:

1. Significant neurological or psychiatric disorders (psychotic disorders, dementia or seizures) that would prohibit the understanding and giving of informed consent.
2. Pregnant or lactating females.
3. Active Hepatitis B or C or history of an HIV infection.
4. Active uncontrolled infection.
5. Billroth II or roux-en Y gastrointestinal alteration people.
Single Dose Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) Associated Pulmonary Hypertension.

This study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of BAY63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (COPD).

In addition to the pharmacodynamic and pharmacokinetic variables, the following laboratory variables were assessed:

* Hematology: Leucocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), platelets, white blood cell (WBC), partial thromboplastin time (PTT), prothrombin time (Quick), international normalized ratio (INR) (prothrombin time expressed in relation to normal value) ;
* Clinical chemistry: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (AP), gamma glutamyl transpeptidase (GGT), creatine phosphokinase (CK), lipase, cholinesterase (CHE), glucose, creatinine, urea, uric acid, bilirubin, total protein, serum albumin, sodium, potassium, calcium, chloride.

And due to the small number of subjects analyzed at several local labs, no summary statistics were provided.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary hypertension due to COPD, undergoing routine invasive measurement of hemodynamic parameters.
* Catheters for measurement of hemodynamic parameters (PAP \[pulmonary artery pressure\], PCWP \[pulmonary capillary wedge pressure\], CO \[cardiac output\], SBP \[systolic blood pressure\]) must be in place independent of the trial.

Exclusion Criteria:

* Acute exacerbation of COPD,
* Pre-existing lung disease other than COPD,
* Acute or severe chronic left heart failure,
* Severe coronary artery disease,
* Uncontrolled arterial hypertension;
* Severe left ventricular hypertrophy,
* Congenital or acquired valvular or myocardial disease,
* Systolic blood pressure \< 100 mmHg,
* Heart rate \< 55 bpm or \>105 bpm,
* PaO2 (arterial partial oxygen pressure)/FiO2 (fraction of inspired oxygen) \< 50 mmHg,
* PaCO2 (arterial partial pressure of carbon dioxide) \> 55 mmHg,
* Severe hepatic insufficiency,
* Severe renal insufficiency.
Surgical Treatment of Low Energy Pelvic Fractures in the Elderly

Since May 2010 the Department of Trauma, Basel University Hospital has performed surgical stabilisation of the posterior pelvic ring on 55 patients. These patients have not received a structured follow up examination or evaluation of outcome after surgery.

Functional outcome of elderly patients with surgical treatment of low energy pelvic ring fractures.

Eligibility Criteria:
Inclusion Criteria:

* Elderly patients (age ≥55y ears) of any ethnic / sociodemographic background
* Pelvic ring fracture after low energy trauma affecting the posterior ring or both (posterior and anterior ring)
* Surgical stabilisation of the pelvic ring at Basel University Hospital between May 2010 and December 2014
* Ambulatory before surgery
* Informed consent for study participation by the patient or legal representatives

Exclusion Criteria:

* Refusal of consent by the patient or legal representatives to participate in the study
* Fractures within the last 3 months before follow-up
* Suspicion of a pathological fracture in the context of known or unknown malignancy
* Symptomatic low back pain with morphological changes, i.e. intervertebral disc displacement, neoplasm metastasis in the axial skeleton, spinal stenosis, vertebral fracture, spondylarthropathy etc.
* Pre-trauma mobility status that precludes achieving a post-trauma mobility status enabling the patient to perform the timed up and go test (e.g. patient in a wheel chair)
DNA Damage and Subfertility in Males - Impact on ART Outcome

A obvational prospective cohort study of men undergoing IUI, IVF and ICSI treatment in Denmark. The aim is to asses the impact of sperm DNA damage, measured as DNA fragmentation index (DFI), on reproductive outcomes after assisted reproductive technology (ART).


Eligibility Criteria:
Inclusion Criteria:

* First cycle treatment

Exclusion Criteria:

* TESA/PESA, more than one cycle
Safety and Immunogenicity of Trivalent Split Influenza Vaccine Using the Strain Composition 2008/2009

Annual trial for registration influenza vaccine with the strain composition for season 2008/2009


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age, mentally competent, willing and able to give informed consent prior to study entry
* available for all the visits scheduled in the study and able to comply with all study requirements
* in good health as determined by: medical history physical examination clinical judgment of the investigator

Exclusion Criteria:

* They Have any serious (in the judgment of the investigator) disease, including but not limited to:

Cancer, except for localized skin cancer Advanced congestive heart failure Chronic obstructive pulmonary disease (COPD) Autoimmune disease (including rheumatoid arthritis) Acute or progressive hepatic disease Acute or progressive renal disease Severe neurological or psychiatric disorder Severe Asthma

* They have a history of any anaphylactic reaction and/or serious allergic reaction following a vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to ovalbumin, chicken protein, chicken feathers, influenza viral protein neomycin or polymyxin).
* Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age) resulting for example from:

receipt of immunosuppressive therapy (any parental or oral cortical steroid or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study; Receipt of immunostimulants, Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study, Suspected or known HIV infection or HIV-related disease.

* Known or suspected history of drug or alcohol abuse.
* They have a bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject;
* Women who are pregnant or woman of childbearing potential unwilling to practice acceptable contraception for the duration of the study (21 days).
* Influenza vaccination or laboratory confirmed influenza within the last 6 months and more than one influenza vaccination within the past 12 months
* Within the past 4 weeks they have received:

another vaccine any investigational agent;

* Any acute or chronic infection requiring systemic antibiotic treatment or antiviral therapy within the last 7 days.
* They have experienced fever (i.e., axillary temperature ≥ 38°C) within the last 3 days
* Simultaneous participation in another clinical study.
* Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives.
* Severely obese with Body Mass Index (BMI) \> 35
* Site personnel involved in evaluation of safety and their immediate relatives are excluded from participation.
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be able to be included in the 48-week follow-on period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser solution, 300 mg twice daily in 4 mL unit dose vials).


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of Core Study
* At least 6 years of age
* Males and females
Compare Sudden Stopping and Weaning of Anticholinergics in Recurrence of OAB Symptoms

Our study included 60 patients with idiopathic OAB and treated with solifenacin 5mg twice daily for one month. After improvement of their condition, we divided the responders into 2 groups, group I stopped the drug suddenly, while group II underwent gradual weaning of the drug.

We started an open-label, prospective, two-arm, randomized controlled trial at Beni-Suef University, from January 2018 to January 2019, including 60 patients suffering from OAB symptoms. Patients were recently diagnosed with idiopathic OAB which was not treated prior to enrollment. All participants signed written informed consents. The study protocol was approved by the ethics committee of our faculty. Patients were allocated into 2 equal groups (30 patients in each group) according to a computer-generated random numeric table after exclusion of those who are not eligible or refused to be included in the study

Eligibility Criteria:
Inclusion Criteria:

* OAB patients.
* Recently diagnosed.

Exclusion Criteria:

* Previous trials of treatment
* UTI, stones, tumors, or Infravesical obstruction.
Interval Training and Resting Metabolism

It has been reported that obese individuals are seated 2 ½ hour more than lean individuals and that non exercise thermo genesis (NEAT) may vary with as much as 2000 Kcal/day between equal size people due to different occupational and leisure time activities. The primary aim of the study is to investigate if 10 weeks of exercise training increase NEAT in sedentary men.

Subject will be randomized to three different training intervention, with 3 exercise session each week for 10 weeks. NEAT will be measured using an activity sensor and recorded over a 7 day period both before and after training.


Eligibility Criteria:
Inclusion Criteria:

* Male gender
* Age 18-50
* BMI 25-30 kg x m2
* No significant comorbidities
* Abel to exercise
* Not partaking in organized physical activity

Exclusion Criteria:

* Inability to exercise due to musculoskeletal conditions
* Known ischemic cardiovascular disease
* High daily physical and occupational activity levels
Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.

Eligibility Criteria:
Inclusion Criteria:

* AHI≥5 from the diagnostic night
* ≥18 years of age
* Prescribed CPAP or Bi-level therapy for OSA
* Existing F\&P Pilairo Q, Eson, Simplus mask users

Exclusion Criteria:

* Inability to give informed consent
* Patient intolerant to CPAP
* Anatomical or physiological conditions making CPAP therapy inappropriate
* History of respiratory disease or carbon dioxide (CO2) retention
* Pregnant or think they may be pregnant
* Investigated by Land Transport Safety Authority
APERTO CVS PMCF Study

Prospective Observational Single Arm study aimed to assess safety and effectiveness of APERTO OTW DCB in treating stenosis and restenosis of central veins in dialysis patients

The APERTO CVS PMCF study is aimed to evaluate safety and effectiveness of treatment of central veins (re)stenosis in dialysis patients at short and mid-term follow up, after treatment with APERTO OTW DCB. Primary endpoint will consist in evaluating the intervention free period for patients treated with APERTO OTW.

APERTO CVS PMCF Study will also collect data for post-market clinical follow up (PMCF) in a CE mark device used according to intended use

Eligibility Criteria:
Inclusion Criteria:

* Patients age \>18, no pregnant women, able to perform fup visits, life expectancy \> 12 months
* Dialysis patients undergoing endovascular angioplasty due to clinically symptomatic stenosis (de novo or restenosis) of the central veins with significant (\>50%) stenosis and diameter
* The target lesion consists of one or more lesions with a target lesion length of less than or equal to 100 mm
* The target blood vessel diameter of the target lesion is between 6.0 and 16.0 mm (in angiographic or ultrasound evaluation);
* If there are other non-target lesions, then non-target lesions must be successfully cured with a not drug coated balloon before treating the target lesion;

Exclusion Criteria:

* Patients with CVS observed and estimated as nonsignificant (\< 50% stenosis) or a vessel \> 12 mm in diameter by visual estimation;
* the patient is now participating in another clinical trial to evaluate drug or medical device;
* patient enrolled for this trial before;
* prenatal pregnancy test result for women of childbearing potential is non-negative, Lactating woman;
* patients, who underwent major surgical procedures (such as thoracotomy, craniotomy, etc.) within 30 days prior to the study;
* patients scheduled to undergo major surgery (eg, thoracotomy, craniotomy, etc.) within 30 days after enrolment;
* central veins lesions have been already treated with DCB before
* presence of a bare metal stent (BMS) or stent graft or vascular access thrombosis in central veins
* patients allergic or intolerant to paclitaxel, or contrast media;
* patients whose life expectancy is less than 1 year
* presence of Thrombus in central veins
* tumor compression
* thoracic inlet syndrome
* patients implanted with pacing or cardioverter devices with leads
* any other central line within the target lesion
* Patients with any contraindications as mentioned in the Instructions for Use (IFU) of the Investigational Device
Robot-assisted Training for Stroke Recovery

The robot assisted therapy is one of the new developed technologies for recovery after stroke. This study aimed to evaluating the effect of robotic gait therapy for motor recovery after stroke.

This study designed an assessor-blinded, randomized, controlled clinical study. The participations followed the study protocol and were randomly divided into the control group and Walkbot group. The control group received conventional functional rehabilitation for 40 min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. Whereas the Walkbot group received conventional physical therapy (session I for 40 min/day) companied with Walkbot training (session II for 30 min/day) 5 days a week for 4 weeks, 40 session in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug treatment can be done at the same time.

Eligibility Criteria:
Inclusion Criteria:

* The subjects (age\>19) with stroke 4 weeks after the onset but within 12 months were included.

Exclusion Criteria:

* Participated in the clinical studies, or received the rehabilitation therapy or therapy associated with the rehabilitation for the purpose of motor function improvement within thirty days before the start of this study.
* Cognitive disabilities or serious psychiatric illness.
* Difficulty in walking due to orthopedic problems.
* Ejection fraction less than 30% due to severe heart disease or with a diagnosis of unstable angina.
* Weight more than 135 kg or height less than 150 cm.
* Pregnancy subjects.
Supplementation of Land-based Stearidonic Acid (SDA)-Rich Oils in Humans

The objective of this study is to investigate the conversion of the precursors ALA and SDA into n-3 LC-PUFA (EPA, DPA and DHA) in humans by oral supplementation of Echium oil in comparison with SDA soybean oil (positive control). In addition, the accumulation of n-3 LC-PUFA is compared between subpopulations of different age, gender and physiological conditions (overweight, increased serum total cholesterol).

N-3 PUFA are important for human health and nutrition. Due to the increasing world population, overfishing of the seas and generally low amounts of n-3 PUFA in major oil crops, there is a demand for new sources of n-3 PUFA.

One approach involves searching for potential vegetable sources of n-3 PUFA; especially those rich in ALA and SDA. The conversion of ALA to SDA in humans depends on the rate-limiting ∆6-desaturation. Plant-derived SDA is therefore a promising precursor regarding endogenous synthesis of n-3 LC-PUFA in humans. The enrichment of n-3 LC-PUFA in human lipids during the supplementation of ALA- and SDA-rich Echium oil will be compared with SDA-rich soybean oil.

Eighty volunteers will be recruited and allocated into four study groups depending on age and BMI. Three groups (each n=20) will receive daily ca. 20 g Echium oil ( group 1 and 2: mean BMI \< 25, with mean age: 25 or 55 years; group 3: mean age 55 and BMI \> 25). One group (n=20) will receive SDA soybean oil ( dose with comparable amount of SDA; BMI \< 25; mean age 25 and 55). The double-blind, randomized, parallel-designed study will start with a two-weeks run-in period, followed by an eight-weeks supplementation period. After the run-in period, one week and eight weeks of oil supplementation blood will be drawn and 24-h urine will be sampled.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* cholesterol lowering drugs
* chronic diseases
* pregnancy, lactation
* intake of nutritional supplements
The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy

To compare the incidence of internal hernia, overall survival and short-term surgical safety of routine closure of the surgically created mesenteric defects versus non-closure for patients with adenocarcinoma of the gastric or esophagogastric junction who underwent radical gastrectomy (D1+/D2 lymph node dissection).


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years；
* Primary lesion is diagnosed with endometrial biopsy as adenocarcinoma of the stomach or esophagogastric junction, including: papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), mixed adenocarcinoma, etc.；
* The gastric primary lesion is located in the antrum, body or fundus of stomach or the esophagogastric junction. It is expected that radical gastrectomy with D1+/D2 lymph node dissection achieves R0 resection (multiple primary cancers are also applicable)；
* BMI(Body Mass Index) \< 30 kg/m2；
* No history of upper abdominal surgery (except for laparoscopic cholecystectomy)；
* No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.；
* Preoperative ECOG (Eastern Cooperative Oncology Group) performance status score 0 or 1；
* Preoperative ASA (American Society of Anesthesiologists) scoring I-III；
* Sufficient vital organ functions；
* Signed informed consent.

Exclusion Criteria:

* Women during pregnancy or lactation；
* Suffer from other malignant tumors within 5 years；
* Preoperative body temperature ≥ 38°C or complicated with infectious diseases requiring systemic treatment；
* Severe mental illness；
* Severe respiratory disease；
* Severe liver and kidney dysfunction；
* History of unstable angina or myocardial infarction within 6 months；
* History of cerebral infarction or cerebral hemorrhage within 6 months；
* Continuous application of glucocorticoid within 1 month (except for topical application)；
* Accompanied by gastric cancer complications (bleeding, perforation, obstruction, etc.) ；
* The patient has participated in or is participating in other clinical studies (within 6 months).