cyrilzakka/clinical-trials huggingface dataset:
Quartet 1457Q Left Ventricular (LV) Lead Investigational Device Exemption (IDE) Study

The primary intent of this study is to assess the safety of the model 1457Q Quartet LV lead at 3 months in a patient population indicated for cardiac resynchronization therapy.

This is a prospective, multi-center, IDE clinical study designed to evaluate the safety of the Model 1457Q Quartet LV lead.

A minimum of 94 and a maximum of 430 subjects will be enrolled in this study at up to 40 centers worldwide.

All subjects successfully implanted with a Quartet 1457Q lead will be followed every 6 months post implant until Pre Market Approval (PMA) is obtained or the study is closed.

Eligibility Criteria:
Inclusion Criteria:

1. Meets current St. Jude Medical clinical indication for implantation of a cardiac resynchronization therapy system:

   " to provide a reduction of the symptoms of moderate to severe heart failure (New York Heart Association Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration, OR " to maintain synchrony of the left and right ventricles in patients who have undergone an Atrio Ventricular nodal ablation for chronic (permanent) atrial fibrillation and have New York Heart Association Functional Class II or III heart failure.
2. Is receiving a new market-approved St. Jude Medical quadripolar cardiac resynchronization therapy system implant with the Quartet 1457Q LV lead.
3. Have the ability to provide informed consent for study participation and is willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
4. Are 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

1. Had a previous unsuccessful commercial or non-Quartet 1457Q LV lead implant attempt
2. Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate
3. Patient is currently participating or plans to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in other studies may be allowed if pre-approval is granted from the study manager.
4. Are pregnant or planning pregnancy in the next 6 months
5. Have a life expectancy of less than 24 months due to any condition
Specialize Dysphagia Training and Knowledge/Competency of Nurses

The aim of this research is to determine the effect of specialized dysphagia training on knowledge and competency of nurses.


Eligibility Criteria:
Inclusion Criteria:

* Nurses of both gender
* At least one year of experience
* Nurses working at Govt. hospital

Exclusion Criteria:

* Undergraduate nursed working as intern at hospital
Comparative Effects of Sprint and Power Training in Cricket Fast Bowlers

Sprints can be a really effective way to improve participants cardiovascular fitness, strength and power, and running economy. Participants can gain bigger improvements and in less time with sprinting than with continuous easy running. Power training typically involves exercises which apply the maximum amount of force as fast as possible. Both these trainings are vital to increase the speed and repeated sprint ability in cricket fast bowlers.

Fast bowling requires a highly specialized and unique training approach as the whole body is used in the delivery of the ball to achieve maximum velocity. For this purpose, the fast bowlers must perform the sprint training which is high intensity interval training as it boosts the speed and power, helps to run faster, build muscles and increase the cardiovascular health. Along with sprint training fast bowlers undergo power training which also helps to run faster, improve strength and speed and maintain fitness.

It will be a Randomized clinical trial with sample size of 34 calculated by G-power with 10- m sprint test, using non probability convenient sampling technique. The study will include physically fit and healthy fast bowlers of age 18-30 years. Participants will be divided into 2 equal experimental groups. One group will perform sprint training which include 10 meter run or repeated sprint ability and other will perform power training including squat jump or countermovement jump consisting of 12 sessions for 4 weeks (3 sessions each week). Data will be assessed by using SPSS version 25

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18- 30 years
2. Fast bowlers (male and female)
3. Physically fit and healthy athletes
4. Players must have fast bowling experience of at least 2 years. -

Exclusion Criteria:

1. Fast bowlers with musculoskeletal conditions ( back pain, foot and ankle injuries, fracture of lower limb and bone deformity, patellar tendinopathy, ligamentous and meniscal injury)
2. Vestibular and visual disorders
3. cardiac and respiratory issues -
The Place of Consultations Specializing in the Diagnosis of Mood Disorders in Strasbourg University Hospital

Mood disorders (depressive disorders and bipolar disorders) are among the ten most worrying diseases of the 21st century according to the WHO.

In order to support psychiatrists in their diagnostic reflection, structures have been created. Since 2009, the Psychiatry Service 2 within the Psychiatry, Mental Health and Addictology Pole of the University Hospitals of Strasbourg has offered specialized consultations in mood disorders.

More than 10 years after the creation of these consultations, it seems interesting to study the profile of the users and to describe the nature of the reports of these in-depth evaluation consultations (diagnosis, therapeutic advice)


Eligibility Criteria:
Inclusion criteria:

* Major subject
* Specialized primary consultation highlighting symptoms of mood disorders with Prof. Berstchy in the psychiatry department 2 in the University Hospital of Strasbourg (patients whose consultation request was linked to symptoms or a diagnosis of ADHD will not be included in the study population).
* Consultation that took place in 2018 and 2019.
* Patient who did not express his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

* Patient opposition to the use of their personal data for scientific research purposes.
* Prior existence of a previous specialist consultation in mood disorders with Prof. Berstchy (the information collected during the first consultation is not accessible)
* Patient under curatorship, guardianship or legal protection
Insulin Resistance as Primary Pathogenesis in Newly Diagnosed, Drug naïve Type 2 Diabetes Patients in Korea

The purpose of this study is investigating the clinical characteristics of newly diagnosed, drug naïve type 2 diabetic patients according to insulin secretion and insulin resistance.

Primary Objective:To investigate whether insulin resistance or insulin deficiency is primary in the pathogenesis of type 2 diabetes mellitus in Korea Secondary Objectives:To investigate proportion of patients with severe insulin deficiency at diagnosis,To investigate proportion of metabolic syndrome in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus,To investigate proportion of obesity in patients with newly diagnosed, drug-naïve type 2 diabetes mellitus

Eligibility Criteria:
Inclusion Criteria:Newly diagnosed, drug naïve type 2 DM patients who gave informed consent, Diagnosis of type 2 DM will be made according to ADA guideline 2009 Exclusion Criteria:Patients age under 18 years
TIMES: Ticagrelor vs. Placebo/ Clopidogrel With Aspirin in Anterior STEMI Patients Treated With Primary PCI

This is a single-centred, double blind randomized controlled trial comparing ticagrelor with placebo in clopidogrel and aspirin loaded patients.

The very early benefit of ticagrelor in STEMI is co-mediated by adenosine cardioprotection maintaining/ improving myocardial microcirculatory function, as well as via platelet inhibition or possibly other pleiotropic effects.

Ticagrelor increases circulating adenosine by reducing cellular re-uptake. Adenosine is a cardioprotective agent that utilizes cellular survival kinase pathways that may have beneficial effects on the microcirculation and myocardium in patients presenting with STEMI. Adenosine is currently used as a treatment for no-reflow and improves MVO post-STEMI when administered during PPCI. A recent study of healthy volunteers has confirmed that non-invasive coronary flow is augmented by ticagrelor and that this is mediated by adenosine. The Investigators propose that the very early beneficial effects of Ticagrelor in ACS may be adenosine mediated cardioprotection, rather than only due to an antiplatelet effect. This important research is original and a natural progression of the ticagrelor story. It expands the adenosine hypothesis and mode of action of ticagrelor and addresses a novel cardioprotective/ microcirculatory mechanism of action.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed verbal consent prior to any study specific procedures taking place with written consent confirmed prior to in-patient cardiac MRI.
2. Male or female adult patient aged 18 - 90 years old
3. Anterior STEMI (ST elevation ≥ 2mmHg in contiguous chest leads) with chest pain symptom onset \< 12 hours

Exclusion Criteria:

1. Cardiogenic shock\*
2. Previous anterior myocardial infarction
3. Unfavourable coronary anatomy for PCI: left main / surgical or distal coronary disease
4. Already prescribed Ticagrelor at the time of admission
5. Factors affecting study drug administration/ absorption: vomiting or allergy
6. Concomitant use of potent CYP3A4 inhibitors/ inducers (e.g ketoconazole and rifampicin) or CYP3A4 substrates with a narrow therapeutic window (e.g. cisapride and ergot alkaloids) or simvastatin / lovostatin \>40mg oral dose.
7. Severe bleeding diathesis or current active bleeding\*
8. History of intracranial haemorrhage
9. Moderate or Severe hepatic impairment
10. Severe asthma or bradycardia/ complete heart block (contraindications to adenosine)\*
11. Severe co-morbidity with a life expectancy \< 3 months.
12. Women of child bearing potential (as determined by direct questioning of the patient to confirm and this will be documented in the medical notes).

    * Patients that are found to have any excluding factor (e.g., unfavourable coronary anatomy for PCI) or develop any excluding factor (e.g., vomiting or cardiogenic shock) before the point of final IMR assessment will be discontinued from the study and followed up at discharge and by telephone at 3 and 12 months for adverse event monitoring purposes only.
Platelet Aggregation and Adenosine Levels Among Patients Taking Ticagrelor or Prasugrel

Prospective, single-center, double blind, double dummy, randomized trial. Platelet function tests and adenosine levels were assessed at baseline and 15 days after taking Ticagrelor with Prasugrel placebo or Prasugrel with Ticagrelor placebo in stable patients with coronary artery disease

This was a prospective, double blinded, randomized trial that compared platelet inhibition and adenosine levels with ticagrelor (180mg loading dose, followed by 90 mg BID) versus prasugrel (60mg loading dose, followed by 10 mg QD) .

Patients were eligible if they were between 18 and 75 years old, were on aspirin without P2Y12 inhibitor at baseline and \> 1 year after documented ACS. Platelet aggregation was compared with the Multiplate ADP® assay, performed at baseline and after 15 days on study medication. Adenosine plasma levels were measured with high performance liquid chromatography at the same time points

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 75 years old
* were on aspirin
* without P2Y12 inhibitor at baseline
* \> 1 year after documented acute coronary syndrome

Exclusion Criteria:

* use of oral anticoagulation or P2Y12 at baseline
* Weight \< 60kg
* History of tia or stroke
* Any coagulation disorders
* Refuse to sign the written consent
Impact of the Cycle Ergometer in Muscle Strength and Pulmonary Function in Patients in Hemodialysis

Muscle strength can be measured by dynamometry, but the investigators did not find in the literature the study of this technique in the quadriceps of patients with chronic kidney disease on hemodialysis. Analyze training impact conducted by cycle ergometer in quadriceps muscle strength in patients with chronic kidney disease during hemodialysis. This study will be a prospective, randomized. Inclusion of 46 patients followed by the dialysis unit of a university hospital, over 18 years, of both genders who underwent hemodialysis for more than six months and signed the consent form and enlightened. Patients will be divided into two groups: Intervention (n = 23) and control (n = 23). All will be evaluated for demographics and quadriceps strength given by standardization of technique, with hard and windy belt. The control group will be reassessed after two months of the initial assessment, since the intervention group held two months of training in hemodialysis a physical therapy protocol with the cycle ergometer.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years
* Performing HD over six months
* Clinically stable
* Patients no diagnosis of lung disease
* Neurological or mioarticular previous or current and agreed to participate in the study and signed informed consent and informed

Exclusion Criteria:

* Patients undergoing elective surgery or emergency six months before or during the performance of the protocol
* Cardiac decompensation
* Used continuous or nocturnal oxygen
* Patients using bracing of the lower limbs.
Multiple Dose Study of Safety and Pharmacokinetics of MEDI0618 in Healthy Volunteers

This is a single centre, randomised, double-blind, placebo-controlled, multiple ascending dose study of MEDI0618 in healthy male and female volunteers.

Subjects will receive MEDI0618 or placebo administered by intravenous infusion or subcutaneous injection.

Safety, tolerability and pharmacokinetics of multiple ascending doses of MEDI0618 will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women of non-child bearing potential
* Aged 18 to 50 years, inclusive
* Weigh more than 50 kg
* Body Mass Index between 18 to 30 kg/m2
* Healthy, in the opinion of the Principal Investigator
* Able to understand and comply with the protocol requirements

Exclusion Criteria:

* Participation in another clinical study with a study drug within 5 half-lives of that study drug or within 3 months prior to screening, whichever is longer
* Donation of blood or plasma within 2 months prior to screening and until after the final follow-up visit
* Poor venous access
* History of severe allergy/hypersensitivity reactions or history of hypersensitivity to immunisations, immunoglobulins or biologics
* Prescence of any clinically significant illness, such as cardiovascular, neurological, pulmonary, hepatic, renal, metabolic, gastro-intestinal, urologic, immunologic or endocrine disease or disorder
* History of cancer within 5 years of screening
* History of drug abuse
* Use of prescriptions or non-prescription medicines within 7 days or 5 half-lives, whichever is longer, prior to administration of study treatments
* Any clinical abnormality on complete physical examination, vitals signs, ECG or clinical laboratory test results at screening or between screening and randomisation
Screening Protocol to Evaluate Volunteers for NIA Approved Studies

The National Institute on Aging (NIA) Intramural Research Program (IRP) has a number ofiRB approved research studies involving human subjects, both normal volunteers and patients. As a means of identifying interested volunteers and other participants in the research process, this screening mechanism is established to identif'y potential eligible participants for NlA protocols.

To participate, volunteers/patients must meet the specific requirements of at least one of the available NlA research studies; this protocol serves as a first step for admitting volunteers/patients to an appropriate approved protocol and creating a contact database for approved NlA studies.

This protocol will facilitate their recruitment into NIA approved studies and provide NlA staff the opportunity to examine subjects where diagnostic observations can be documented and evaluated for research potential.

The screening protocol is designed to evaluate volunteers/patients for participation in IRB approved clinical studies of the National Institute on Aging (NIA). An additional purpose of this protocol is to develop a registry of individuals who have been evaluated through the NIA Clinical Research Unit screening clinic. To participate, volunteers/patients must meet the specific requirements of at least one of the available NIA research studies. This protocol serves as a first step for admitting volunteers/patients to an appropriate approved protocol, and it is used to develop a registry of individuals who meet eligibility criteria for existing research projects.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. All volunteers/patients who meet the criteria of an approved NIA protocol.
  2. People with diagnosed or undiagnosed conditions
  3. Patients may be eligible if they have rare, unusual, interesting or unknown conditions that require diagnosis

EXCLUSION CRITERIA:

1. Subjects unable to provide informed consent.
2. The volunteer/patient does not meet the criteria of any approved NIA protocol and does not wish to remain in the contact database for future studies.
3. Volunteer/patient has contacted the NIA Clinical Research Protocol Office and notified them that they would like to be removed and no longer contacted for NIA approved studies. They will be removed.
Influence of Bio-Oss Collagen Grafting at Implant Placement on Buccal Bone Volume Regeneration

to validate the capacity of bio-oss collagen (xenograft block+ collagen type I) placed solely without a membrane on a thin (0.5-1.8mm) buccal bone wall after delayed implant placement to regenerate bone volume. 30 patients requiring dental implants and presenting a deficient bone ridge (a ridge with reduced marginal bone width ≤ 2mm) were selected. The bone regeneration technique used in this study:

* Pre-operatively:

  * cone beam computed tomography CBCT
  * 1 minute mouthwash with a 0.12% Chlorhexidine solution
  * Full thickness muco-periosteal flap and ridge curettage.
  * Drilling and implant placement (any implant system)
  * Adjustment and placement of the "Bio-Oss Collagen" in the regeneration site without a fixation membrane.
  * Hermetic wound closure with U-shaped and simple stitches using 5/0 and 6/0 PGA resorbable material.
* Post-operatively:

  * Medication:

    * Amoxicilline (1g) or Clindamycine (300mg)
    * Analgesic, (paracetamol + codeine)
  * Mouthwash with a solution of 0.12% Chlorhexidine
  * cone beam computed tomography CBCT

    * 4 months postoperatively: CBCT

Bio-oss collagen is placed on the buccal side after implant placement and adapted to have the bone defect morphology. the full thickness flap is then closed without membrane placement and the bone bock is fixed in place through sutures only. CBCT images were taken immediately postoperatively and at 4 months after bone grafting. Imaging superposition (on ITK software) and measurements of buccal bone gain were effectuated to evaluate the efficiency of this regeneration technique. evaluation of buccal bone regeneration through linear radiographic measurements and evaluation of the % of grafted bone resorption will indicate the success of this technique


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* Smoking \<10 cigarettes/day (Light smoker)
* Good general health.
* Absence of acute infection: edema, suppuration, abscess, spontaneous bleeding.

Exclusion Criteria:

* A pregnant or nursing mother
* Pathologies that may impair bone healing: diabetes, autoimmune diseases, corticosteroids, chemotherapy.

Orthodontic treatment in progress or planned

- Adjacent risk teeth
Living Kidney Donor Lost Wages Trial

This study aims to evaluate the effectiveness of offering reimbursement for living donor lost wages on the rate of live donor kidney transplantation.

Live donor kidney transplantation (LDKT) accelerates the path to transplantation and yields superior outcomes compared to dialysis and deceased donor kidney transplantation (KT). However, the annual number of LDKTs has declined over the last decade, particularly among minority and low-income patients. The investigators hypothesize, and have preliminary data to support, that the financial impact on living donors (LDs) is a major contributor to the LDKT decline and for persistent racial disparities in LDKT rates. Many LDs have substantial non-reimbursed direct and indirect costs, most notably the loss of income or wages following surgery. In this study, the investigators will: (1) evaluate the effectiveness of offering reimbursement for LD lost wages on the LDKT rate; (2) examine whether offering reimbursement for LD lost wages reduces known racial disparities in LDKT; and (3) determine whether study outcomes differ significantly by maximum reimbursement amount for LD lost wages.

Eligibility Criteria:
Inclusion Criteria:

* For KT patients:
* Chronic Kidney Disease (CKD) stage 4/5
* Approved for kidney transplant (KT) listing or active on KT waiting list
* For patients listed at multiple centers: primary listing at Beth Israel Deaconess Medical Center (BIDMC)
* For LDs:
* Their KT candidate is enrolled in the trial

Exclusion Criteria:

* For KT patients:
* KT candidate has a potential LD approved, with surgery scheduled
* Listed for multi-organ transplantation
* Temporarily unavailable (TU) status on KT waiting list
* Current enrollment in another study to increase LDKT likelihood
* For LDs:
* Not residing in the US
Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus

Primary objective of this study was to assess the impact of the two prevalent therapeutic options, CxL and CxL combined with topography-guided photorefractive keratectomy (t-PRK), on both anterior and posterior corneal High order aberations (HOAs).

The Pentacam Classic (Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04) was used for the sake of the study.32 patients with keratoconus were included in the study. Of them, 19 patients underwent CxL treatment (CxL group), while the rest 13 patients underwent CxL combined with t-PRK (tCxL) \[tCxL group\]. If both eyes were eligible, only one eye was enrolled in the study.Regarding Scheimpflug camera (Pentacam Classic, Oculus Optikgerate GmbH, Heidelberg, Germany, software version 1.14r04 ) measurements, acceptable maps had at least 10.0mm of corneal coverage. Moreover, images with extrapolated data in the central 9.0mm zone were excluded.

For both anterior and posterior corneal surfaces, Pentacam-derived HOAs parameters for both pupil diameters of 4mm and 6mm were calculated, as well as the HOA root mean square (RMS)values. Pentacam-derived HOA measurements were obtained one day prior to treatment and then one year post-op.The impact of the surgical technique (either CXL or tCXL) on spherocylindrical error was evaluated by power vector analysis as described before. Furthermore, manifest refractions comprising of sphere (S), cylinder (C) and axis (φ), were converted into three dioptric powers (M, J0 and J45). Moreover, we calculated the overall blurring strength (B) of the spherocylindrical error by measuring the length of the produced vector.

Eligibility Criteria:
Inclusion Criteria:

* progressive keratoconus

Exclusion Criteria:

* glaucoma or suspicion for glaucoma,
* central corneal thickness (CCT) less than 400μm,
* K-readings more than 60D,
* history of herpetic keratitis,
* pregnancy or nursing,
* underlying autoimmune disease