cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation Of The PARADYM RF Device

The PARADYM RF ICDs (DR, VR and CRT)have been implemented with 3 innovative features:

The new RV autothreshold algorithm which will help the physician in his diagnosis avoiding potential lost of capture.

Then, the ICD devices have also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study.

Finally the study will report the electrical and handling performances of the new left ventricular lead.

In the PARADYM RF clinical study, the sponsor aims at:

* Demonstrating the performances of the right ventricular autothreshold algorithm ;
* Reporting the adverse events documented in the study;
* Reporting electrical performances of Sorin Group PARADYM ICDs, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives;
* Assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data.
* Reporting the Situs 2 MV left ventricular lead performances;
* Reporting the Situs 2 MV LV lead mechanical handling.

Thus, this study intends to show that PARADYM RF ICDs operate safely and appropriately in intended-use as part of an ICD system.

Eligibility Criteria:
Inclusion Criteria:

* In case of implantation of VR 9250: patient has been prescribed the implantation or replacement of a single-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of single-chamber ICD;
* In case of implantation of DR 9550: patient has been prescribed the implantation or replacement of a dual-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC2 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of dual-chamber ICD;
* In case of implantation of CRT 9750: patient has been prescribed the implantation or replacement of a triple-chamber ICD system accordingly to the relevant currently-approved ACC/AHA/ESC3 guidelines or any relevant currently-approved local guidelines for the implantation or replacement of triple-chamber ICD;

Exclusion Criteria:

* 1 VT/VF is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause;
* 2 VT/VF occurred during the acute phase of infarction (\< 3 weeks) or during an unstable ischemic phase;
* 3 VF was caused by electrocution;
* 4 Incessant VT/VF ;
* 5 Implanted pacemaker that is not going to be explanted or otherwise disabled;
* 6 Patient is unable to attend the scheduled follow-ups at the implanting centre;
* 7 Patient is already enrolled in another ongoing clinical study;
* 8 Patient is unable to understand the aim of the study and its procedure;
* 9 Patient refuses to cooperate;
* 10 Patient is unable or refuses to provide informed consent;
* 11 Patient is minor (less than 18-year old);
* 12 Patient is pregnant;
* 13 Patient has life expectancy of less than 1 year;
* 14 Patient is forfeiture of freedom or under guardianship.
Interaction of Muscle Dystrophy, Glucose Metabolism and Insulin Sensitivity

The aim of this project to characterize systemic and organ-specific (subcutaneous adipose tissue and skeletal muscle) metabolic responses at rest and during standardized, moderate exercise after an oral glucose load in patients with various geneticaly heritable foms of skeletal muscle dystrophies. Metabolic responses will be monitored by indirect calorimetry (canopy and/or metabolic chamber at rest and during exercise) and microdialysis (adipose tissue and skeletal muscle at rest) before and after an oral glucose load (75 g).


Eligibility Criteria:
Inclusion Criteria:

* controls: healthy, no metabolic, endocrine, neurologic or other diseases
* patients: genetically confirmed diagnosis of muscle dystrophy

Exclusion Criteria:

* known hemorrhagic diseases / coagulopathies
* intake of oral anti-coagulant drugs (control of PTT, INR and platelet count before study entry)
* insulin-dependent Diabetes mellitus
* pregnancy and lactation period
* chronic use of non-steroidal antiphlogistics
* alcohol and drug abuse
* Claustrophobia • gleichzeitige Teilnahme an einer anderen Studie; Teilnahme an einer Studie vor weniger als zwei Monaten Unfähigkeit, die mündlichen und schriftlichen Informationen zur Studie zu verstehen und das schriftliche Einverständnis zu geben
Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes Patients

This study is being carried out to see if dapagliflozin as an addition to metformin is effective and safe in treating patients with type 2 diabetes when compared to glipizide (sulphonylurea) as an addition to metformin treatment.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Treated with oral anti-diabetic drug therapy therapy including Metformin for at least 8 weeks prior to enrolment
* HbA1c \>6.5% and \</=10%

Exclusion Criteria:

* Type 1 Diabetes
* Insulin therapy within one year of enrolment
* Renal (kidney) failure or dysfunction
Effects of LDL Apheresis System on the Expression of Genes Involved in Lipoprotein Metabolism and Inflammation in Homozygotes for Familial Hypercholesterolemia

Familial hypercholesterolemia (FH) is an autosomal codominant single-gene disorder caused by mutations in the LDL receptor gene that disrupt the normal clearance of LDL particles from the plasma compartment. Heterozygous patients present a 2- to 3-fold raise in plasma LDL-cholesterol (C) concentrations, tendinous xanthomatosis and premature atherosclerotic coronary heart disease (CHD), usually occurring between the age of 35 and 55 years. Since the mid-1970s, LDL-C has been removed from the blood of patients using plasmapheresis, and this technique has been shown to improve the life expectancy of FH homozygotes. LDL apheresis selectively removes LDL particles but not immunoglobulins and other beneficial proteins, thereby overcoming a potential drawback of the traditional plasmapheresis method. LDL-C is effectively reduced by more than 60% immediately after LDL apheresis, although LDL levels rebound rapidly.

Dextran sulfate adsorption is a commonly apheresis technique used in familial hypercholesterolemia patients. In this apheresis plasma is separated from red blood cells and passed over columns of cellulose beads containing dextran sulfate which binds apolipoprotein B (apoB) by a highly selective electrostatic binding mechanism. Since LDL, very-low density lipoprotein (VLDL), and Lipoprotein (a) all contain apoB, dextran sulfate adsorption apheresis selectively reduces these lipoproteins while having little effect on the non-apoB containing HDL particles. In clinical practice, LDL apheresis reduces the rate of future cardiovascular events and has been postulated to have additional effects on potentially pro-atherogenic factors. Some proteins have been identified with adhesive characteristics to lipoproteins, rheological, immunological and inflammation relevant proteins16-19 that influence microcirculation as well as the inflammatory response. However, no studies have yet to investigate the impact of LDL apheresis on the expression of different genes involved in cardiovascular disease.

The main objective of the present research project is to investigate the impact of the LDL apheresis dextran sulfate adsorption system on the messenger ribonucleic acid (mRNA) expression of genes involved in cardiovascular disease using microarrays analysis in 9 FH homozygotes.


Eligibility Criteria:
Inclusion Criteria:

* Homozygotes for familial hypercholesterolemia who receive lipid apheresis
* Aged between 18-60 years

Exclusion Criteria:

* Smokers (\> 1 cigarette/day)
* Subjects with a previous history of cardiovascular disease
* Subjects with type 2 diabetes
* Subjects with a monogenic dyslipidemia that it is not homozygote for familial hypercholesterolemia
* Subjects with endocrine or gastrointestinal disorders
* History of alcohol or drug abuse within the past 2 years
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
Meriter Mindfulness Training for Smokers Program and Study

The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking Cessation Program. The Meriter Smoking Cessation Program has two interventions, the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention. Study activities include one 10-minute study visit and two 5-minute survey phone calls.

The Meriter Smoking Cessation Study tests participants in the Meriter Smoking Cessation Program. Meriter Hospital and clinic patients will be recruited into the Meriter Smoking Cessation Program. The Meriter Smoking Cessation Program has two interventions, the Mindfulness Training for Smokers (MTS) intervention and the Quit Line (QL) Intervention. Study activities include one 10-minute study visit and two 5-minute survey phone calls.

MTS: Mindfulness Training for Smokers Intervention. This is the 7-week quit smoking intervention developed by the PI.

QL: Quit Line Intervention. This is a program starting at makes use of the Wisconsin Tobacco Quit Line.

Meriter Smoking Cessation Program: A program offering the MTS and QL interventions to smokers at Meriter Hospital and Clinics.

Meriter Smoking Cessation Study: This is a study comprised of 2 phone surveys and 1 study visit that tests participants in the MTS and QL intervention. Participants in the Meriter Smoking cessation program will have the opportunity to decide if they would like to be in the study.

Eligibility Criteria:
Inclusion Criteria:

* everyday smoker

Exclusion Criteria:

* current alcohol or other drug addiction
New Interactive Sensor-home-based Hand Training to Improve Dexterity

Primary objective of this study is to explore the impact of a 3-week upper limb hand function training in patients with PD, MS or stroke. The benefits on hand function of this training program will be evaluated. The hypothesize is that the 3-week upper limb hand function training improves finger dexterity.

Patients with Parkinson's disease (PD), multiple sclerosis (MS) or stroke often suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as cooking, shopping and regular medication intake. The investigators explore the effects of a new, interactive, sensor-home-based upper limb hand training on upper limb related ADL in patients with PD, MS or stroke.

Eligibility Criteria:
Inclusion Criteria:

* Patients with confirmed PD, according to UK Brain bank Criteria (Hughes et al., 1992) or
* MS patients with relapsing-remitting MS (RRMS), secondary-progressive MS (SPMS) or primary progressive MS (PPMS) according to the revised McDonald's criteria or
* subacute stroke
* written and signed informed consent
* self-reported hand function problems

or

* healthy subject
* written and signed informed consent
* no self-reported hand function problems

Exclusion Criteria:

* MoCA \<21/30
* psychiatric disease
* participation on other interventional trials
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Effect of Probiotic Supplement on Improvement of Depressive Symptoms in Patients with Substance-Induced Depressive Disorder

This study investigates the potential of probiotics as a therapeutic intervention for Substance-Induced Depressive Disorder (SIDD). The primary question the study aims to answer is: Can a four-week course of probiotics improve depressive symptoms and alter immune markers in patients diagnosed with SIDD, compared to a placebo?

The study uses a double-blind, placebo-controlled, randomized clinical trial design with 40 participants to explore this question by measuring clinical outcomes using BDI and HAM-A and immunological markers.


Eligibility Criteria:
Inclusion Criteria:Males and females, aged between 18 and 70 years. Diagnosis of Substance Induced Depressive Disorder as per DSM-5 criteria. Absence of significant internal diseases as per exclusion criteria

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Exclusion Criteria: Pregnant or lactating. Patients who for any reason cannot comply with adequate follow-up.

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Preimplantation Genetic Diagnosis (PGD) With Gonadotropin-releasing Hormone (GnRH) Agonist Versus Antagonist

The aim of our study is to define the optimal ovarian stimulation protocol concerning PGD and for this reason we plan a randomized controlled trial (RCT) comparing gonadotropin-releasing hormone (GnRH) agonist protocol versus GnRH antagonist protocol. The follicle stimulating hormone (FSH) preparation in both arms will be highly purified FSH (Menopur®).

Patients will be randomized at the outpatient clinic in two groups.

Eligibility Criteria:
Inclusion Criteria:

* ≤ 39 years the day of oocyte retrieval
* BMI ≤ 29
* cycle rank 1
* menstrual cycle 25-36 days
* PGD or preimplantation genetic screening (PGS) requested
* ICSI
* Single embryo transfer (SET) on day 5

Exclusion Criteria:

* Polycystic Ovary Syndrome (PCOS) (according Rotterdam criteria)
* Hormonal disturbances
* Endometriosis grade III and IV
Investigation of a New 2-piece Ostomy Product in People With an Ileostomy or Colostomy

The purpose of this study is to investigate the influence of a new ostomy product on the peristomal fit for people with an ileo- or colostomy.


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent and in DK: signed a letter of authority
* Be at least 18 years of age and have full legal capacity
* Have had their ileostomy or colostomy for at least 3 months
* Able to use a baseplate size 15 to 40 mm
* Be able to handle the product themselves
* Normally experience faeces under the baseplate at least 3 times during 2 weeks
* Currently using a 2-piece flat product with mechanical coupling
* Willing to test both the Coloplast test product and the comparator product
* Willing to use an open bag size maxi during the investigation
* Willing to use Coloplast test product and comparator products without initial use of accessories (except tube paste / belt)
* Willing to use at least 1 baseplate every 3rd day during the investigation
* Is able to use a custom cut product
* Be suitable for participating in the investigation

Exclusion Criteria:

* Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer)
* Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (lotion or spray). Systemic steroid (tablet/injection) treatment are allowed
* Are pregnant or breastfeeding
* Are participating in other interventional clinical investigations or have previously participated in this investigation
* Use irrigation during the investigation (flush the intestines with water)
* Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
* Have a loop ostomy
* Have known hypersensitivity towards any of the products used in the investigation
Clinical Test Report for Blood Pressure Meter CH-609

Blood pressure meter model CH-609 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.


Eligibility Criteria:
Inclusion Criteria:

* 85 subjects with a wide range of blood pressure were selected.

Exclusion Criteria:

* Subjects could be taking antihypertensive medication, but excluded in atrial fibrillation or with any sustained arrhythmia.
Cord Blood 25(oh)-Vitamin D Level in Preterm Infants and Associated Morbidities

Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. The aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.

It was shown that vitamin D play important role in the pathogenesis of long term morbidities of newborn. Experimental and observational studies have shown that vitamin D deficiency may be associated with an increased risk for non-bone diseases and/or abnormal development for the other systems of fetus. The aim of this study is to determine the relationship between cord blood 25-hydroxyvitamin D (25 (OH) D) concentrations and the subsequent risk of morbidities including RDS, PDA, NEC, BPD AND ROP in preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* infants \<32 weeks of gestational age

Exclusion Criteria:

* infants with major congenital abnormality
* infants \>32 weeks of gestational age
The Effect of Calisthenic Exercise on Aerobic Capacity, Muscle Strength and Quality of Life in Hemodialysis Patients

The aimed this study is to examine the effects of calisthenic exercises on aerobic capacities, muscle strength and quality of life in patients receiving hemodialysis treatment.

The study is a randomized single-blind placebo-controlled study. . At the beginning and end of the study, all patients will be asked to answer questions including demographic information and a quality of life questionnaire for kidney patients. A 6-minute walking test and a 30-second sit-stand test will be applied by the research physiotherapist to measure their aerobic capacity. Again, a dynamometer will be used to measure muscle strength.

The hypotheses the investigators will test for this purpors; H0 Calisthenic exercise in hemodialysis patients increases aerobic capacity. H1Calisthenic exercise in hemodialysis patients increases muscle strength.H2 Calisthenic exercise in hemodialysis patients improves the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Being treated in the Hemodialysis unit of Aydın Adnan Menderes University Faculty of Medicine Research and Application Hospital,
* Having good cognitive functions
* Not having regular exercise habits
* Not having a physical disability
* Being between 18-60 years old
* Speaking and understanding Turkish
* Being willing to participate in the study

Exclusion Criteria:

* Neurologically affected patients (such as cerebrovascular accident, Gullian Barre)
* Patients with musculoskeletal problems that prevent exercise
* Patients with advanced heart failure, patients with unstable angina pectoris
* Patients with chronic liver failure
* Patients with a history of cardiovascular events (recent within 12 months)
Genetic Basis of Pacing-induced Cardiomyopathy

The purpose of this study is to collect a saliva sample from patients with a pacemaker to study genes involved in cardiomyopathy, a condition where the heart muscle is abnormal.

DNA will be extracted from the saliva to test for changes in genes related to cardiomyopathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been assessed for cardiomyopathy

Exclusion Criteria:

* Patients who do not have adequate follow up care to determine if they do or do not have cardiomyopathy
Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain

This single arm study will evaluate whether Xermelo (telotristat ethyl) associated weight gain is affects lean body mass, dietary intake, and physical and cognitive functioning among neuroendocrine tumor (NET) patients with a history of carcinoid syndrome.

The purpose of this study is to examine the mechanisms of weight gain associated with the drug telotristat ethyl (Xermelo) among patients with a neuroendocrine tumor (NET) with history of carcinoid syndrome. We want to know if taking Xermelo affects patients' lean body mass, quality of life, dietary intake, and physical and cognitive functioning during treatment. A better understanding of the mechanisms of weight gain from Xermelo may allow us to determine whether this drug may be beneficial for treating carcinoid syndrome, cachexia, or weight loss seen in other diseases.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Histopathologically confirmed diagnosis of a metastatic NET.
* Documented history of carcinoid syndrome.
* Currently receiving treatment with long-acting SSAs with a plan to initiate therapy with telotristat-ethyl as per standard of care.
* ECOG performance status 0-1 and/or Karnofsky \>60%.
* Greater than or equal to 3 month life expectancy.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Patients experiencing more than 12 watery BMs per day associated with volume contraction, dehydration, or hypotension, or showing evidence of enteric infection.
* History of short bowel syndrome.
* Clinically important baseline elevation in liver function tests.
* Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* Malignant ascites requiring paracenteses.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Bowel obstruction, partial, or total.
* Pregnancy
* Patients with unresolved grade 3/4 adverse effects of prior therapy at time of enrollment, other than diarrhea
Surgery in Treating Patients With Liver Metastasis From a Gastrointestinal Stromal Tumor

RATIONALE: Surgery may be an effective treatment for liver metastasis from a gastrointestinal stromal tumor.

PURPOSE: This phase II trial is studying how well surgery works in treating patients with liver metastasis from a gastrointestinal stromal tumor.

OBJECTIVES:

* To evaluate the safety and efficacy of surgery in patients with resectable hepatic metastasis secondary to gastrointestinal stromal tumor.

OUTLINE: This is a multicenter study.

Patients undergo surgical resection of hepatic metastasis.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of gastrointestinal stromal tumor (GIST)
* Hepatic metastasis meeting the following criteria:

  * Clinically diagnosed as surgically resectable with no macroscopic residual tumor
  * No more than 3 hepatic metastases
  * Synchronous hepatic metastasis allowed provided primary tumor is also resectable
  * Does not require radiofrequency ablation and/or microwave coagulation therapy to control the disease
* No extrahepatic metastasis
* No history of GIST recurrence

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Leukocyte count ≥ 3,000/μL
* Neutrophil count ≥ 1,500/μL
* Hemoglobin ≥ 8.0 g/dL
* Platelet count ≥ 75,000/μL
* Total bilirubin ≤ 2.0 mg/dL
* ALT and AST \< 120 IU/L
* GTP \< 210 IU/L
* Not pregnant
* No poorly controlled diabetes mellitus
* No NYHA class III-IV cardiac function
* No hepatitis B or hepatitis B carriers
* No other malignancy requiring treatment

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No prior interventional radiology for metastatic disease
* No prior or concurrent imatinib mesylate
* No other concurrent treatment