cyrilzakka/clinical-trials huggingface dataset:
Clinical Investigation Plan for the AVOPT Data Collection Clinical Study

The purpose of this study is to collect clinical data for the development and evaluation of a new device feature for automatic AV-delay (AVD) optimization.


Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with an Evia DR(T) or Entovis DR(T) pacemaker
* Possessing 1st or 3rd degree AV block
* Implanted with Biotronik bipolar RA and RV leads
* Implantation date should be at least 4 months prior to this study

Exclusion Criteria:

* Patient is a minor (18 years old or younger)
* Patient is pregnant or breast-feeding
* Patient does not have the legal capacity to provide consent
* Patient has Mobitz type I or Mobitz type II heart block
* Patient has persistent supraventricular tachycardia (including atrial fibrillation) or ectopic beats.
* Patient is participating in other clinical studies during the clinical study
* Patient is strictly pacemaker dependent (physician discretion)
The Effect of a Plant-blend Protein Isolate on Post-exercise Myofibrillar Protein Synthesis

Dietary protein ingestion is required to maximise the anabolic response during the recovery from resistance exercise. Whey protein is considered the optimal dietary strategy to maximise post-exercise muscle protein synthesis, but animal-protein production and consumption is associated with growing environmental and ethical concerns. Plant-based protein sources are considered of lesser anabolic quality than isonitrogenous boluses of animal-derived protein attributed to, at least in part, deficiencies in key essential amino acid. Blending different protein sources may overcome amino acid deficiencies and potentiate the post-exercise anabolic response. In the present study the investigators assessed the post-exercise muscle protein synthetic response following the ingestion of a novel plant-based protein isolate when compared with an isonitrogenous bolus of whey protein in healthy young, resistance trained women and men.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 - 30
* Resistance trained (\>3 times per week structured resistance exercise training for at least 3 months)

Exclusion Criteria:

* Any metabolic impairment
* Any cardiovascular impairment
* Smoking
* Lactose intolerance
* Allergies to products containing dairy, meat or nuts
* Prescribed intake of over the counter pharmaceuticals
LUS in Acute Heart Failure Therapeutic Adaptation

Evaluate lung ultrasound aspect according to diuretics dosage evolution in patients hospitalized for acute heart failure.

EPPICA is an observational and prospective cohort study. The study goal is to evaluate LUS aspect evolution according to diuretics dosage in patients hospitalized for acute heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Acute heart failure diagnosed by a senior physician in the medical department, with a confirmation of a second senior physician.
* Hospitalised in the medical department.
* No objection from the patient of his trusted person.

Exclusion Criteria:

* Administrative supervision or deprived of their liberty
* Pulmonary conditions distracting lung ultrasound (pneumonectomy, pulmonary fibrosis)
* Chronically dialysed
Clinical Evaluation of Postoperative Healing After Conventional And Laser Assisted Frenectomy Operations

The aim of this randomized controlled parallel-designed study was to evaluate clinical healing and patient comfort after conventional and diode laser assisted frenectomy operations in case of high papillary frenulum attachment. Forty-eight patients with high papillary frenulum attachments were included in the study. Patients were randomly divided into three groups; conventional frenectomy operation (Group C), frenectomy operation using diode laser (Group L) and diode laser asissted frenectomy with horizontal incision on the periosteum (Group L+P). Postoperative pain, difficulty in speaking and eating scores were assessed postoperative 3 hours and 1, 7, 14, 21 and 45 days using Visual Analogue Scale (VAS). Evaluation of epithelialization of the wound surface was carried out via hydrogen peroxide to the surface using a dental injector at postoperative 7, 14, 21 and 45 days. Plaque index, gingival index, bleeding on probing and probing depth were assessed at baseline and postoperative 7, 14, 21 and 45 days. All data were compared between groups and within each group.


Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy, nonsmoker, aged between 18 and 65, high papillary frenulum attachment diagnosed according to Mirko et al (Mirko et al, 1974), not received any periodontal treatment within the last 3 months, presence of at least central, lateral incisors and canines at the upper jaw, and consent to participate in the study.

Exclusion Criteria:

* Any systemic disease that might interfere with the prognosis of periodontal disease (i.e., diabetes mellitus, HIV infection), smoking, antibiotics, anti-inflammatory drugs or any other medication taken within the last 6 months that might affect the outcome of the study, any physical limitations or restrictions that might preclude normal oral hygiene procedures.
Assessing Current Clinical Concepts in Dental Practice

This purpose of this database is to collect, store and use appropriately derived data from routine patient care in a specialist dental practice. Comprehensive observational data will be gathered, systematically organised and be continuously updated. This data will be used to evaluate treatment outcomes and identify areas for improvement. This will contribute to the existing evidence base to validate new and current clinical concepts in dentistry. Patient consent will be sought for this, and all data extracted from patient notes will be stored and used anonymously. Use of the Oral Health Impact Profile (OHIP) -14 questionnaire pre and post treatment will be used to assess patient satisfaction with outcomes.

Specialist dentistry uses a combination of techniques resulting from joint decisions between clinicians and patients, aimed at giving the patient what is perceived to be the best possible outcome. However, as new techniques and approaches develop, there is capacity for more evidence to justify one treatment option over another, both clinically and most importantly, from the patient perspective.

The aim of this project is to set up a research database which will enable the collection and storage of appropriately derived data from routine patient care and from patient questionnaires (using OHIP-14). This data will be used in cohort studies/case series reports/comparative studies with other practices.

It is believed that this process will provide an effective way of evidencing predictable outcomes, assist in the development of improved clinical techniques, provide additional guidance and support for patients, and further clinical research in dental practice. In addition, implementation of studies to track patient satisfaction with clinical outcomes will provide advanced support in the decision making process.

All adult patients treated at The Campbell Clinic will be approached for consent. This will be an ongoing process, to maximize sample size. Treatment decisions will be continue to be made jointly by clinician and patient and will not be altered by participation in this study. Patient consent will be sought, and all data will be anonymised for storage in the database.

Eligibility Criteria:
Inclusion Criteria:

1. be a patient at The Campbell Clinic
2. be planning to undergo or have undergone specialist dental treatment, usually involved dental implants
3. be able to read and understand Patient Information Sheet
4. Have signed informed consent form

Exclusion Criteria:

1. concern that patient has not understood patient information sheet (e.g. due to language /interpretation issues)
2. not willing to sign consent form
3. any medical condition/medication that might compromise implant success
Biomarkers In Seizure To Predict Recurrence and Severe Outcomes

We study the hypothesis that combination of Proteine S100 beta and Copeptin within normal ranges can rule out seizure recurrences and severe outcome, and allow early discharge from the emergency department

Prospective study for a 12 month period in Paris (France) and London (UK).

Inclusion criteria :

* seizure within 24h of attendance to an Emergency department (ED)
* or seizure in the ED

Exclusion Criterie :

* pregnancy
* prisoneer

Primary endpoint :

- recurrence of seizure, hospitalisation more than 24 hours or death within seven days

Secondary endpoint :

* Hospital free days at day 7 and day 28
* Death, ICU admission, or neurosurgical intervention at day 7 and day 28
* Return visit to the ED or re admission at day 7 and day 28

data collection:

* demographics
* past medical history, medication
* vital signs (Heart rate, temperature, Pulse oxymetry, blood pressure, GCS) on arrival
* Pathology (White cell count, Sodium, Calcium, Glucose, lactate)
* Protein S100B and Copeptin
* Seizure characteristics (Witnessed, simple, partial, complex, provoked, acute symptomatic, idiopathic)
* Discharge plan, outcomes

Follow up at day 7 and day 28, hospital visit or phone call

Eligibility Criteria:
Inclusion Criteria:

* Seizure within 24 hours of ED attendance
* Or Seizure in the ED

Exclusion Criteria:

* Pregnancy
* Prisoner
* age \< 18 years old
Safety Study of XP12B in Women With Menorrhagia

The purpose of this study is to evaluate the safety of XP12B in women with heavy menstrual bleeding associated with menorrhagia.


Eligibility Criteria:
Inclusion Criteria:

* Women with menorrhagia
* 18-49 years of age
* Regularly occuring menstrual periods

Exclusion Criteria:

* History or presence of clinically significant disease or abnormalities that might confound the study
* History of bilateral oophorectomy or hysterectomy
A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus

The purpose of this study is to examine if once-weekly dulaglutide is efficient and safe compared to glimepiride in participants with type 2 diabetes mellitus who have inadequate glycemic control with oral antihyperglycemic medication (OAM) or are OAM-naïve.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus
* OAM-naïve or have been taking OAM monotherapy for at least 3 months
* Glycosylated Hemoglobin (HbA1c) value of ≥7.0% to ≤10.5% for OAM-naïve participants or ≥6.5% to ≤10.0% for participants taking OAM monotherapy
* Adult men or adult non-pregnant, non-breastfeeding women
* Stable weight (±5%) ≥3 months prior to screening
* Body mass index (BMI) of ≥19.0 to ≤35.0 kilograms per square meter (kg/m\^2)

Exclusion Criteria:

* Have type 1 diabetes mellitus
* Have previously been treated with a glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1 analog, or any other incretin mimetic during the 3 months before screening
* Are currently taking dipeptidylpeptidase-IV (DPP-IV) inhibitor and thiazolidinediones (TZD) during the 3 months before screening
* Have gastric emptying abnormality
* Have cardiac disorder defined as unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, heart failure, arrhythmia, transient ischemic attack, or stroke
* Have poorly controlled hypertension (systolic blood pressure above 160 millimeters of mercury \[mmHg\] or diastolic blood pressure above 95 mmHg)
* Have impaired liver function
* Have impaired kidney function
* Have history of chronic pancreatitis or acute pancreatitis
* Have a serum calcitonin ≥20 picogram/milliliter (pg/mL)
* Have a personal or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma or multiple endocrine neoplasia type 2 (MEN 2)
Blood Pressure and Central Haemodynamics in Healthy Adults Stratified by MTHFR Genotype

Approximately 12% of the world's population have a have a common C677T polymorphism in the gene encoding the folate metabolising enzyme, methylenetetrahydrofolate reductase (MTHFR). Homozygosity for the polymorphism (TT genotype) appears to result in an increased requirement for the B-vitamins folic acid and riboflavin and more importantly results in an increased risk of developing high blood pressure (BP). Previous work from our Centre has demonstrated significantly higher BP in those with the TT genotype. This work has been conducted in cohorts with premature cardiovascular disease (CVD) and hypertension without overt CVD, but the effect in younger, healthier individuals is unexplored. To date our studies have also focused on BP as the primary outcome, but newer markers of vascular health including central pressure and hemodynamics have emerged as superior prognostic indicators of CVD. The effect of the TT genotype on these measures is thus an important area for investigation and may help us understand the mechanism linking the genotype with BP, which is currently unknown. As adults with the TT genotype appear to have increased requirements for riboflavin and folic acid, and BP in TT adults appears to be riboflavin dependent, the influence of these vitamins on central measures is an area for consideration. Study Design This is an observational study investigating the blood pressure profiles of healthy adults aged 18-65 years, stratified by MTHFR genotype. Apparently healthy adults will be recruited from workplaces and the general community across Northern Ireland and screened for the polymorphism via buccal swab. Those with the TT genotype and a similar number of non-TT (i.e. CC/CT) genotype individuals will be contacted and asked to come to attend a one-off appointment. Brachial BP will be assessed by an electronic BP monitor, central BP and central haemodynamics (augmentation index, augmentation pressure and pulse wave velocity) will be assessed by SphygmoCor XCEL. In addition, anthropometric measurements, health and lifestyle information and a blood sample will be obtained. Data will be statistically analysed using SPSS software to if determine differences between gentoype groups exist.


Eligibility Criteria:
Inclusion Criteria:

* Pre-screened for MTHFR 677TT genotype
* Aged at least 18 years old

Exclusion Criteria:

* Younger than 18 years
* Pregnant
Study of Prognostic Factors in Aortic Dissection Type B

Clinical outcomes of chronic type B aortic dissections are unknown, especially in case of false lumen expansion and risk of rupture. Data of literature give us some indications about prognosis. The 1-year survival rate is about 80%, but we deplore the 25% rate of mortality at 3 years despite follow-up.The only known predictive factors are the initial diameter of more than 4 cm and the persistence of a false lumen patent.However, actual means of follow-up do not allow to predict severe complications. The aim of the sudy is to propose a diagnostic and preventive strategy for the follow-up of chronic type B aortic dissections treated medically.

The primary objective is then to evaluate the prognostic role of 18-FDG-PET Scan in such patients in order to predict the risk of aortic diameter growth of more than 5 mm in 1 year and/or of an aortic dissections extension at 1 year. The secondary objectives are to evaluate the link between fibrosis biomarkers MMP et TIMP) and the results of imaging results (evolution of diameter and extension and results of PET-Scan imaging) Methods: 100 patients to be included in 3 years History of chronic type B aortic dissection, treated medically, evolving since more than 1 month and less than 5 years.

Expected results: Prognostic contribution of 18FDG-PET-Scan and biomarkers for the identification of patients at high risk of evolution. Elaboration of a decisional algorithm about follow-up modalities of chronic aortic dissections. Demonstration of a correlation between aortic diameter growth or aortic dissection extension and intensity of marker fixation with 18-FDG-PET-Scan.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Chronic type B aortic dissection, without surgical treatment
* Medically treated patient
* Medical treatment since more than 1 month and less than 5 years
* Aortic dissection localization : below left subclavian artery and alow femoral artery
* Affiliation to a social security system
* Patient who have given informed consent

Exclusion Criteria:

* History of malignant pathology
* Aortic dissection since less than 1 month or more than 5 years
* Inflammatory or infectious disease of the aorta
* Uncontrolled infectious disease
* Iodine Allergy
* Severe renal insufficiency (cockcroft clearance \<30 mL/min)
* Patient under guardianship or curators
* Any associated medical or psychological condition wich could compromise the patient's ability to participate in the study
* Inability to be submitted to the study follow-up for geographical, social or psychological reasons
* Current pregnancy or lack of effective contraception during their reproductive years
* Suckle
Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome

The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).

Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 3 weeks ; while in group B (Coasting group), coasting (withholding gonadotrophins while maintaining pituitary suppression) follow up every day by measuring E2 for 3 days then either giving triggering or cycle cancellation is done

Eligibility Criteria:
Inclusion Criteria:

* Infertile women undergoing intracytoplasmic sperm injection or polycystic ovarian syndrome (PCO) with one of the following:

  * Presence of more than 20 follicles by ultrasound
  * E2 more than 3000 pg/ml
  * Retrieval of more than 15 follicles

Exclusion Criteria:

* None
SAVE- Oral Antibiotics for Treatment of Vertebral Osteomyelitis

Background The current Danish National Guideline for treatment of pyogenic vertebral osteomyelitis (PVO) recommends 6 weeks antibiotic (AB) treatment, with a 2-week intravenous (IV) AB lead-in followed by 4 weeks oral AB for uncomplicated PVO, and 12 weeks AB treatment with a 2-4-week IV AB lead-in followed by 8 weeks oral AB for complicated PVO.

The primary objective of the current study is to investigate whether shortening the duration of IV AB to one week for both complicated and uncomplicated PVO is non-inferior to the current Danish National Guideline.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Diagnosed with PVO by a physician based on clinical symptoms and findings consistent with PVO in combination with diagnostic imaging (MRI, PET/CT or PET/MRI)
3. The physician responsible for the patient decides to treat the patient for PVO
4. At time of randomization CRP has decreased to \< 75% of peak value or to \< 20 mg/l
5. At the time of randomization patient has received maximum 7 days of appropriate IV AB for PVO -

Exclusion Criteria:

1. Previous episodes of PVO within the past 24 months
2. Spinal implants inserted prior to current episode of PVO
3. Hypersensitivity to an AB intended for use in the patient and no alternative drugs available.
4. Oral ABs not possible due to suspicion of reduced absorption
5. Oral Abs not possible due to verified or expected bacterial susceptibility or due to expected toxicity of available regimen
6. Identification of fungus, mold, TB, Brucella, Actinomyces, Nocardia and P. aeruginosa as etiology
7. Severe immunocompromise defined as primary immunodeficiencies, uncontrolled HIV/AIDS, organ transplant recipients, hematological malignancies, patients undergoing biological therapy or chemotherapy and patients treated with prednisolone \>=20 mg daily \>14 days
8. Verified or expected reduced compliance (for example iv drug use)
9. Pregnancy
10. Breastfeeding
11. Women of childbearing potential, who at the time of inclusion are not using and/or who will not use an effective anticonception method during the treatment period.
12. Patients not capable of providing informed consent at time of screening for inclusion
13. Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization -
PARACHUTE V PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE.

Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the CE marked CardioKinetix Parachute Implant System.

Prospective, multi-center, post-market, non-randomized, nested-control, observational study of the European Conformity Approved (CE marked) CardioKinetix Parachute Implant System. The primary objective is to establish quality-of-life and cardiac output benefit of the Parachute Implant of patients presenting with symptoms of heart failure due to ischemic heart disease. A maximum of 105 treated patients and approximately 25 control patients may be enrolled, with a maximum of 25 treated patients enrolled from any one center. The Primary Endpoint is an improvement of Quality of Life of patients treated with the Parachute Implant at 6 months compared to baseline using the Minnesota Living with Heart Failure (MLWHF) Questionnaire. The Secondary Endpoint is an improvement in Stroke Volume Index (mL/m2) of patients treated with the Parachute Implant at post-procedure compared to pre-procedure.

Eligibility Criteria:
Inclusion Criteria:

* Post MI structural heart dysfunction represented by left ventricular (LV) wall motion abnormality (WMA)
* Symptomatic Heart Failure with reduced Ejection Fraction (EF) (≤ 40%)
* Receiving stable medication for heart failure according to the European Society of Cardiology (ESC) Heart Failure (HF) Guidelines
* \>18 years of age
* Provide written informed consent
* Agree to the protocol-required follow-up

Exclusion Criteria:

* Acute myocardial infarction (MI) of the left anterior descending territory within 90 days of enrollment or patients with suspected evolving MI at time of enrollment
* Cardiogenic shock within 72 hours of enrollment
* A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated
* Other hemodynamically structural heart interventions or heart failure device treatment at time of Parachute implant, e.g. mitral valve clip or cardiac resynchronization therapy).
* Co-morbidities associated with a life expectancy of less than 12-months
* Treatment Arm only (Control Arm excluded from this criteria): Anatomical characteristics not suitable for treatment with the Parachute Implant device as screened by magnetic resonance imaging (MRI) or computerized tomography (CT). (Characteristics include inappropriate size and shape of the left ventricle, pseudo chordae or trabeculations interfering with device placement.)
Expert Behaviors USGRA

Expert-performance begins by focusing specifically on the end-product of training and experience in the hands of the expert. By defining expert behaviors and techniques, investigators can guide learners and non-expert practitioners by offering them models to emulate. At Toronto Western Hospital (TWH), there are more than ten expert attending regional anesthesiologists who routinely provide clinical patient care in the block room. The primary objective of this study is to qualitatively and quantitatively examine behavior of experts performing ultrasound guided regional anesthesia techniques to identify those which are consistent and unique, and which may underpin expert performance.


Eligibility Criteria:
Inclusion Criteria:

* All elective patients coming to the regional BR at TWH aged 18-80

Exclusion Criteria:

* Any contraindication to USGRA (LA allergy, patient refusal, infection at injection site, etc.)
* Inability to read or speak or comprehend English fluently