cyrilzakka/clinical-trials huggingface dataset:
Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA)

A unique single-lead dual-chamber implantable cardioverter-defibrillator (ICD) system (produced by Biotronik, Germany) features a conventional electrode in the ventricle (anchored in the ventricular apex) and a floating electrode (ring on the lead body) in the atrium, capable of sensing atrial electrical signals. The purpose of this study is to determine whether this system detects a supraventricular tachyarrhythmia (e.g. atrial fibrillation, atrial tachycardia) in the equivalent manner as conventional dual-lead dual-chamber ICDs using two separate electrodes anchored in the ventricle and in the atrium, respectively.

Supraventricular tachyarrhythmia (SVT) is the main cause of inappropriate therapy in patients with single-chamber implantable cardioverter-defibrillators (ICDs). To minimize inappropriate shock delivery, ICDs should sense both atrial and ventricular intracardiac signals. Dual-chamber ICDs are used for this purpose, but are associated with increased postoperative complications due to the implantation of a separate atrial lead. It has to be shown that a novel single-lead dual-chamber ICD-system with enhanced SVT discrimination can achieve the same specificity in discriminating SVT episodes as conventional dual-chamber ICD, without the disadvantage of the implantation of several leads. In this study patients eligible for dual-chamber ICD therapy who do not need atrial pacing will receive either a single-lead dual-chamber ICD (Belos A+ and Kainox A+ electrode) or a dual-lead dual-chamber ICD (Belos DR). SMART detection algorithm will be used in both study groups for discrimination between atrial and ventricular tachyarrhythmias. Atrial tachyarrhythmia episodes are facultatively induced in both groups at implantation or predischarge via a bipolar stimulation catheter. Induced episodes and the corresponding ICD intervention (detection and therapy or inhibition of therapy) are documented. Follow-ups are scheduled for 1, 3, 6 and 12 months after implantation. ICD intervention, particularly related to spontaneous SVT episodes, will be evaluated based on ICD diagnostic memory data interrogated at follow-up controls.

Eligibility Criteria:
Inclusion Criteria:

* ICD indication according to American College of Cardiology/American Heart Association (ACC/AHA) guidelines.
* Informed consent

Exclusion Criteria:

* Permanent atrial fibrillation
* Requirement for atrial pacing
* Patient is underage
* No signed patient agreement
* Patient life expectancy under 6 months
Outcome of TAMIS Mucosal Resection in Patients With ODS

Patients, aged 18 - 90 years, undergoing TAMIS mucosectomy at the Department of General Surgery at the Medical University of Vienna are enrolled into our study.

Primary endpoint is the outcome (improvement of ODS symptoms), defined by ODS score.

Various surgical approaches for the treatment of obstructed defecation syndrome (ODS) commonly associated with rectocele and rectal intussusception have been investigated in the literature. Methods such as stapled transanal resection of the rectum (STARR) and ventral prosthesis rectopexy (VPR) show promising results at least in the short term. In the long-term, however, the results do not seem convincing. Schiano di Visconte et al. report a recurrence of ODS symptoms in 40 percent of the patients, treated with stapled transanal rectal resection in a 10-year follow up. The clinical outcome of surgical treatment of ODS using transanal minimally invasive surgery (TAMIS) in the sense of a mucosal resection without stapling technique has not yet been investigated. This project is designed to show the short-term outcome of non-stapled mucosal resection through TAMIS.

Eligibility Criteria:
Inclusion Criteria:

* Need of minimal invasive mucosal resection due to obstructed defecation syndrome after several unsuccessful conservative treatments over a period of more than 6 months with presence of an organic cause (Symptomatic intussusception with or without rectocele) in medical examinations (defecography, endoluminal ultrasound, endoanal manometry)
* Age: 18-90 years
* Ability and willingness to understand and comply with planned interventions during the study.
* Voluntarily signed informed consent after a full explanation of the study to the participant.

Exclusion Criteria:

* Any physical or mental disorder could interfere with the participant's safety during the clinical trial or with the study objectives.
* Inability to communicate well with the investigator due to language problems or reduced mental development.
* Inability or unwillingness to give written informed consent.
Boom-IBD Clinical Trial

Feasibility study of neuromodulation in patients with IBD.

The study will evaluate responses of patients with IBD treated with neuromodulation at various intervals.

Eligibility Criteria:
General Inclusion Criteria:

* Male or female
* 18 to 75 years of age
* Diagnosed with Crohn's Disease or ulcerative colitis
* Ability and willingness to consent to participate by signing the informed consent form
* Ability to comply with the protocol and willingness to comply with all follow-up requirements
* Still have part or all of their colon

General Exclusion Criteria (The subject must not meet ANY of the following criteria):

* Any significant medical condition that is likely to interfere with study procedures, device operation, or likely to confound the results of the study
* Any psychiatric or personality disorder at the discretion of the study investigator
* Any active bacterial infection with a risk of bacteremia or sepsis (e.g. presence of abscess)
* Active clostridium difficile infection of the colon
* Active cytomegalovirus (CMV) infection of the colon
* Evidence of colonic perforation
* Fulminant colitis requiring emergency surgery
* Microscopic, ischemic or infectious colitis
* Unresected neoplasia of the colon
* Colonic stricture unable to pass a colonoscope
* History of cancer including melanoma (except for localized skin cancers) within 2 years
* Participation in another clinical trial within the past 30 days of device implant
* Investigational drug for the treatment of inflammatory bowel disease within 6 months of device implant
* Inability to operate the patient programmer
Bone Mineral Density Changes Among Clinical Subtypes of Parkinson's Disease

The bone loss in Parkinson's disease (PD) emerges as a non-motor symptom with motor and non-motor outcomes, such as fracture and musculoskeletal pain. Bone mineral density (BMD) is decreasing in patients with PD when compared to sex and age-matched healthy controls. The changes in BMD according to clinical subtypes of PD is unknown. The investigators are planning to compare the BMD status between the tremor dominant and postural instability and gait difficulty type of PD.

The investigators are planning to complete this study between January and February 2019. This study will be performed at Ordu University Education and Research Hospital, Neurology Department.

All patients admitted to the outpatient clinic will be evaluated in terms of inclusion criteria. The control group consisted of people who do not have any orthopedic, neurological or metabolic disorders which may affect the BMD.

Eligibility Criteria:
For TDT and PIGDT PD group

Inclusion Criteria:

Clinical diagnosis of idiopathic Parkinson's disease Age of 40-85 years

Exclusion Criteria:

Having additional orthopedic and neurological disorders Having metabolic disease, Having steroid drug use

For Control group

The similar age and sex-matched healthy individuals who have no orthopedic, metabolic and neurological disorders, and steroid use will be included in the study.
Exploratory Study to Evaluate the Effect of SYN111 (Rufinamide) in Patients With Generalized Anxiety Disorder (GAD)

A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder.

This was an exploratory study to evaluate the effect of 500 or 1000 mg per day for 8 weeks of Rufinamide compared to placebo on measures of anxiety in patients with Generalized Anxiety Disorder, and to determine tolerability of Rufinamide in this population.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient 18-65
* Meet Diagnostic and Statistical Manual,(DSM) IV criteria for GAD
* Have moderate to severe anxiety
* Sign IRB (Institutional Review Board) approved consent and can comply with visits and procedures
* Women of childbearing potential must use acceptable method of contraception

Exclusion Criteria:

* Have diagnosis of adjustment disorder or anxiety disorder Not otherwise specified (NOS)
* Have diagnosis of specific phobia
* Have diagnosis of antisocial personality disorder or other Axis II Disorder
* Have diagnosis of substance abuse disorder within 3 months of study entry
* Have diagnosis of major depressive disorder or panic disorder within 6 months of study entry
* Have diagnosis of PTSD, eating disorder substance dependence disorder within 12 months of study entry
* Have diagnosis anytime during lifetime of schizophrenia or other psychotic disorder, bipolar mood disorder, Obsessive-Compulsive Disorder (OCD), psychosurgery
* Require medication to treat GAD other than study medication
* Failed to show improvement with past treatment for GAD
* Excessively consume caffeine
* Are receiving treatment with prohibited medications
* Uncontrolled thyroid condition
* Positive urine drug screen
* Obese
* Clinically significant ECG finding
* Participating in other clinical trial
* Clinically significant out of range lab value
* Past exposure to rufinamide
* Pregnant or nursing females
Study of the Influence of Vaccination in HIV Viral Load and Immunologic Responses Against HIV

The purpose of this study is to determine whether an immunization schedule is beneficial to HIV-infected patients with CD4 recount over 500 cells/mm3 and undetectable viral load.

As HIV-infected patients are considered immunocompromised, it is generally recommended that they have to receipt appropriate vaccines. However data are conflicting concerning potential harmful effects following the administration of commercial vaccines in HIV-infected patients. Transient increases ("blips") in the viral load have been described associated with a single dose of vaccine, with the potential risk of developing resistance to HAART. On the other hand, there has been described that patients with blips can have an increase in HIV-specific immune responses, which may help to improve the viral control.

Comparison: We have performed a clinical trial to evaluate the effect of a vaccination program in successfully treated HIV-infected adults on HAART compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Asymptomatic HIV infection
* CD4\>500/mm3 \>6 months prior to inclusion
* CD4 nadir \>300/mm3
* Being under HAART \> 1 year prior to inclusion
* Viral load\<200 copies/mL \> 6 months prior to inclusion
* Viral load previous to treatment \>5000 copies/mL
* Informed consent

Exclusion Criteria:

* Pregnant women
* Basal creatinine \>2.5 mg/dL
* Allergy to either a vaccine or a ingredient of it
* Chronic hepatitis B
* GOT/GPT \> 250 IU/L
Study Evaluating Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects

Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of non-childbearing potential aged 18 to 50 years inclusive on study day 1.
* Body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram.

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, hematologic, neurologic, or psychiatric disease.
* Clinically significant abnormal standard EEG at screening.
* Consumption of any caffeine-containing products or alcoholic beverages within 48 hours before study day 1.
Evaluation of the Body Slimming Effect of TCI904

To assess the efficacy of Lactobacillus delbrueckii ssp. bulgaricus TCI904 on body slimming


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20
* BMI ≥ 23 or male body fat ≥ 25%, female body fat ≥ 30%.
* History of Atherosclerotic cardiovascular disease (including cerebrovascular disease, coronary heart disease, peripheral vascular disease) or Type 2 diabetes or have any of the following factors: Age Men ≥ 45 years, Women ≥ 55 years or amenorrhea, hypertension, hyperlipidemia (total cholesterol \> 200 mg/dL or low-density lipoprotein cholesterol LDL-C \> 130 mg/dL or triglyceride TG \> 130 mg/dL), high-density lipoprotein cholesterol HDL-C \< 40 mg/dL.
* If people have routinely taken drugs for lowering blood sugar, blood pressure or blood lipids, there is no significant dose change within three months (variation ≤ 20%).
* Volunteers who are willing to participate in and complete the trial plan after explaining by the researchers, and sign the consent form.

Exclusion Criteria:

* History of diabetic ketoacidosis.
* Medical records documented cerebrovascular disease, acute myocardial infarction or coronary artery bypass surgery or placement of coronary artery stents or peripheral vascular disease within the last 6 months.
* Known acute infectious illness within the past month with \> 7 days of antibiotics.
* Known short-term use of steroids, NSAIDs, anti-rejection drugs, interferon, immunomodulators or changes in long-term doses due to any factors in the past month.
* Have used any weight loss drugs (including Orlistate, Lorcaserin, liraglutide) within the past three months.
* History of any cancer in the past 5 years or still receiving cancer treatment.
* Patients with abnormal liver function (GOT or GPT greater than 3 times the upper limit of normal) or known cirrhosis.
* Patients with abnormal kidney function (eGFR \< 30 mL/min/1.73 m\^2).
* Patients with a history of alcoholism.
* Have participated in any other interventional clinical research within the last month.
* Pregnant and lactating women.
* Known history of allergy to the test substance.
* Patients who are judged inappropriate by the trial host.
Study Of Factors Favoring The Onset Of Novo Atrial Fibrillation In The Immediate Aftermath Of Coronary Artery Bypass Surgery

Before la surgery:

Transthoracic cardiac echography will be done systematically, to measure among other things the size of the left atrium.

During surgery:

Surgery under extracorporeal circulation: tissue samples will be harvested from the right atrium (one before clamping of the aorta (T0= pre-ischemia sample), immediately before declamping of the aorta (T1= post-ischemia sample).

Surgery without extracorporeal circulation: tissue samples from the right atrium before CABG (T0) and a second sample after CABG (T1).

In parallel with the harvesting of cardiac tissue, blood samples will be taken at different times (H0, H3, H24) to correlate tissue data with systemic data. These will be taken by the anesthetists.

After the surgery:

Holter ECG will be set up for 7 days of continuous recording. Each patient will fill in an observation notebook. The biological samples will be analysed immediately and the biological data obtained will be recorded in the observation notebook.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided written informed consent
* Patients covered by the national health insurance scheme
* Heart surgery (CABG) with and without extracorporeal circulation
* Elective or deferred emergency surgery
* Consecutive patients aged less than 80 years

Exclusion Criteria:

* Patients less than 18, under guardianship
* Patients over 18, under guardianship
* Patients who do not understand the study data
* Patients undergoing emergency surgery who therefore cannot be given or understand the explanations for the study (patients in shock, intubated patients with mechanical ventilation)
* History of heart surgery
* History of AF
* Treatment with Cordarone.
Exendin PET/CT for Imaging of Paragangliomas

Functional imaging of paragangliomas (PGLs) is not unequivocal. Existing functional imaging modalities show good but variable results in PGLs, warranting the search for additional molecular imaging targets. Investigators aim to evaluate the glucagon-like peptide 1 receptor (GLP-1R) as a novel target for molecular imaging of PGLs. For this purpose investigators will use the tracer 68Ga-NODAGA-exendin 4 for positron emission tomography/computed tomography (PET/CT) imaging.

Rationale:

Functional imaging of paragangliomas (PGLs) is not unequivocal. Existing functional imaging modalities show good but variable results in PGLs, warranting the search for additional molecular imaging targets. Investigators aim to evaluate the glucagon-like peptide 1 receptor (GLP-1R) as a novel target for molecular imaging of PGLs. For this purpose investigators will use the tracer 68Ga-NODAGA-exendin 4 for positron emission tomography/computed tomography (PET/CT) imaging.

Objective:

The primary objective is to examine the feasibility of 68Ga-exendin-4 PET/CT for localization and functional characterization of PGLs.

Study design:

In this prospective pilot imaging study 68Ga-exendin-4 PET/CT will be performed in 10 patients with confirmed PGL who have undergone CT, somatostatin receptor (SSTR) PET/CT and 18F-FDG PET/CT (as standard diagnostic procedures) and are scheduled for surgery. 100 ± 10 MBq 68Ga-NODAGA-exendin-4 will be administered to 10 patients in total. In the first 5 patients PET/CT imaging will be performed 1, 2 and 4 hours after injection to determine the optimal imaging timepoint for the remainder of the patients, which will be applied in the remaining patients.

The images will be reconstructed and evaluated by a nuclear medicine physician who is blinded to the results of the CT, SSTR PET/CT and 18F-FDG PET/CT to assess tumor detection. Additionally, quantitative analysis of 68Ga-exendin-4, SSTR PET and 18F-FDG PET/CT images will be performed. After the patients have undergone surgery, immunohistochemical analysis of surgical specimens will be performed to assess GLP-1R expression, which will be compared with in vivo tracer uptake.

Eligibility Criteria:
Inclusion Criteria:

* Proven sympathetic PGL with a single tumor detected using standard diagnostic imaging
* No evidence of metastatic disease
* CT, SSTR PET/CT and 18F-FDG PET/CT performed (golden standard diagnostic imaging)
* Scheduled for surgery
* Able to sign informed consent

Exclusion Criteria:

* Breast feeding
* Pregnancy or the wish to become pregnant within 1 month
* Calculated creatinine clearance below 40ml/min
* Evidence of other malignancy than PGL in conventional imaging (suspicious liver, bone and lung lesions)
* Age \< 18 years
* Not able to sign informed consent
Düsseldorf Bread Study

The hypothesis is to be tested that eating carbohydrate-reduced bread over three months leads to a significant weight difference compared to conventional, carbohydrate-rich bread.

Carbohydrate reduction is an important element for weight loss or can also be used to keep weight constant. Since the majority of the carbohydrates consumed daily in industrialized countries come from bread and rolls, the present study will examine the effect of two different types of bread on the weight development of overweight bread consumers. The two types of bread differ in their carbohydrate content and the hypothesis is to be tested that eating carbohydrate-reduced bread over three months leads to a significant weight difference compared to conventional, carbohydrate-rich bread. The comparison of the two types of bread is carried out triple blinded. During two visits (before and after the bread consumption phase), the health status is determined with physical parameters and laboratory parameters from a blood test. The primary endpoint is body weight. Overall, this study will for the first time allow extensive statements to be made on the health value of the three-month consumption of two different types of bread.

Eligibility Criteria:
Inclusion Criteria:

- body mass index of at least 27 kg/m2

Exclusion Criteria:

* serious illness with hospitalization in the last 3 months
* Changes in body weight (estimated weekly average) by more than 2 kg in the past 4 weeks
* Non-smoking status for less than 3 months
* Change of smoking habits planned during the study
* acute diseases such as respiratory or gastrointestinal infections
* Chronic diseases, e.g. Tumor diseases, chronic obstructive pulmonary disease (COPD), asthma, dementia, intestinal diseases, diabetes
* regular use of medication (except contraceptives) such as Lipid lowering, blood pressure lowering, weight-regulating medication, aspirin
* no contraception in women of childbearing age or breastfeeding a child
* high sporting activity (≥ 1 hour per day)
* planned absence of\> 7 days during the intervention phase
A Phase I Study of BMS-641988 in Japanese Patients With Castration Resistant Prostate Cancer

The purpose of this clinical study is to assess the safety and tolerability of BMS-641988 once daily orally in Japanese patients with castration resistant prostate cancer


Eligibility Criteria:
Inclusion Criteria:

* Patients with castration-resistant prostate cancer and serum testosterone ≤50 ng/dL progressive to current therapy who satisfy the inclusion and exclusion criteria
Comparison of Anterior Vaginal Sacrospinofixation With Laparoscopic Promontofixation for the Treatment of Anterior and Apical Genitourinary Prolapse

The investigators anticipate a reduced risk of post-operational de novo stress urinary incontinence following surgery for vaginal sacrospinofixation, associated with reduced costs, comparable functional and anatomical efficacy and no increase in morbidity and rate of dyspareunia with the new treatment


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* Patient must be available for 12 month follow-up
* Patient is ≥50 and \<80 years old
* Patient has pelvic prolapse stage 2 or above according to international POP-Q score, concerning the anterior and apical compartments, justifying surgical treatment
* Patients not having preoperational stress urinary incontinence or having mild stress urinary incontinence not causing significant functional problems (response \<2 to question 17 of PFDI-20 questionnaire). It is possible that patients with hidden stress urinary incontinence will be recruited

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The patient is under safeguard of justice or state guardianship
* The subject refuses to sign the consent
* Patient with communication issues preventing comprehension of information and administration of questionnaires
* Pelvic prolapse not affect anterior and apical compartments, regardless of stage
* Patient with preoperative dyspareunia (patients with mild sexual discomfort related to prolapse may be included
* Patient presents with preoperative stress urinary incontinence responsible of significant functional incapacity (response ≥2 to question 17 of PFDI-20 questionnaire).
* Indication for concomitant suburethral sling
* Patient with previous history of surgery for stress urinary incontinence
* Indication of concomitant perineorrhaphy surgery with or without myorrhaphy (in both groups).
* Contra-indication for general anesthetic
* Current urinary infection
* Current vaginal infection