cyrilzakka/clinical-trials huggingface dataset:
PROGRESS Trial - Prophylactic Gabapentin for Relief of Symptoms and Improved Swallowing

Enrollment is only available to patients enrolled on the Optima II study (NCT03107182).

The purpose of this trial is to compare rates of opioid use at completion of radiation for patients with Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 2 oral mucositis after receiving definitive nonoperative locoregional therapy with or without prophylactic gabapentin as part of best supportive care for locoregionally-advanced, HPV-related oropharyngeal cancer. Secondary purposes include comparison of total equivalent opioid dosage above baseline opioid use at end of treatment, quality of life metrics, swallowing function, feeding tube dependence, and protocol compliance in patients managed with best support care with or without prophylactic gabapentin. Rates of gabapentin-related side effects and discontinuation will also be investigated.

Enrollment is only available to patients enrolled on the Optima II study (NCT03107182).

Primary objective: To compare rates of opioid requirement as a function of supportive care in patients experiencing CTCAE grade ≥2 oral mucositis at completion of radiation or chemoradiation as part of OPTIMA II

Secondary objectives: To compare total opioid equivalent dose above baseline opioid requirement at end of radiation, quality of life metrics, swallowing function, feeding-tube dependence, and protocol compliance in patients managed with best supportive care with or without prophylactic gabapentin. To investigate rates of gabapentin-related toxicity and discontinuation for patients treated on protocol.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment to OPTIMA II trial (NCT03107182)

Exclusion Criteria:

* Ineligible for enrollment to OPTIMA II trial (NCT03107182)
* Prior gabapentin therapy
* Creatinine clearance of \< 45 mL/minute
* Documented intolerance, allergy, or hypersensitivity to gabapentin
* Hemodialysis or peritoneal dialysis
Controlled Trial of Brexpiprazole For The Treatment of Co-occurring Schizophrenia and Substance Use Disorder

The proposed study is a 3-site, 12-week, novel, feasibility, investigation of patients who have co-occurring diagnoses of schizophrenia and current substance use disorder (alcohol, cocaine, heroin, or cannabis). Eighty patients will be randomly assigned to switch to brexpiprazole (the brexpiprazole group) or remain on the same antipsychotic treatment (the control group). The study will be conducted at 3 sites in the US. The investigators expect to enroll 80 subjects across 3 sites. UMass Medical School, Worcester MA is the lead site. Sub-sites include Massachusetts General Hospital (MGH) and the University of North Carolina at Chapel Hill (UNC).

STUDY OBJECTIVES

The primary objectives of the study include:

1. examine the effect of brexpiprazole treatment on the number of days of substance use in the past week as measured by the Timeline Follow-Back (TLFB) assessment;
2. examine the effect of brexpiprazole treatment on substance craving using 100-mm visual analogue scale (VAS).

The secondary objectives are to examine the effect of brexpiprazole treatment on:

1. the dollar amount spent on substances in the past week;
2. the psychiatric symptoms as measured using PANSS

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years old
2. Meets the DSM-5 criteria for diagnoses of schizophrenia or schizoaffective disorder and substance use disorder (alcohol, cocaine, heroin, or cannabis) based on the Structured Clinical Interview for the DSM-5 (SCID)
3. Uses substance on at least 4 of the past 30 days prior to randomization with at least one use in the week prior to randomization for one of substances (cocaine, heroin, cannabis or alcohol) assessed by the TLFB interview
4. Stable dose of antipsychotic agent for at least one month
5. Well established compliance with outpatient medications
6. Female subjects of child-bearing potential are required to practice appropriate birth control methods during the study.

Exclusion Criteria:

1. Psychiatrically unstable
2. Currently meets DSM-5 criteria for any substance use disorder other than caffeine, nicotine, alcohol, cocaine, heroin and cannabis
3. Significant, unstable medical conditions including severe cardiovascular, hepatic, renal or other medical diseases
4. History of a seizure disorder
5. Pregnancy or breastfeeding
6. Currently on aripiprazole or cariprazine
7. Currently on medications to treat substance use (disulfiram, naltrexone, acamprosate,methadone, buprenorphine, varenicline or buproprion)
Quantra® System With the QPlus® Cartridge in Double-lung Transplantation

Transfusion in lung transplantation is common, and despite improved techniques and limitations in the use of mechanical circulatory support (MCS), the incidence of massive transfusion has remained stable over the years. The consequences of blood transfusion (blood cells, plasma, platelet concentrates) are deleterious for patients and increase primary graft dysfunction and mortality risk.

Whole blood viscoelastic testing devices have shown its effectiveness in monitoring coagulation and fibrinolytic function during cardiac surgery, liver transplantation or trauma. So far, few delocalized biology tools have been evaluated in lung transplantation.

The main objective of this study is to determine if the use of a transfusion algorithm based on whole blood viscoelastic test with Quantra® test reduce transfusion during lung transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing double-lung transplantation
* Patient is ≥ 18 years-old
* Patient is willing to participate, and is willing to consent
* Patient affiliated to a national health insurance

Exclusion Criteria:

* Patient is younger than 18 years-old
* Patient with an indication for non double-lung transplantation
* Patient under extracorporeal membrane oxygenation in bridge to transplantation
* Patient with surgery under cardiopulmonary bypass
* Patient benefiting from a multi-organ transplantation
* Patient being deprived of liberty or under guardianship
* Patient refusing to participate
Comparison of the in Vivo Stability of 2 Cementless TKA Designs

The goal of this randomized controlled trial is to analyze the stability of a cementless Total Knee Arthroplasty (TKA) over time and compare it to a well-documented implant in patients with knee osteoarthritis. The main aim is to answer if there is a difference in stability over time as a measure of long time survivorship in these 2 implants.

50 participants will be randomly allocated to receive either the Triathlon Tritanium (Stryker) or the Global Medacta Knee Sphere (GMK Sphere, Medacta) 3D printed cementless TKAs.

Total joint replacement is an efficacious treatment for osteoarthritis of hips and knees. Both TKA and Total Hip Artrhoplasties (THA) have excellent implant survivorship. However, patients' satisfaction is lower in TKA than THA. A possible cause of the discrepancy is the unnatural knee kinematics after TKA. Various implants designs have been developed to solve the problem. The most common fixation mode is cemented TKA with good survival up to 15 years. However, newer series in younger patients also have shown lasting survival with cementless implants (Nilsson KG, Prudhon JL). Among various different designs, the medially stabilized total knee, which are designed to reproduce natural knee kinematics with a medial ball-in-socked design, is a promising implant design (No authors listed). Dynamically the medial pivot knee performs more naturally (Bragonzoni L,Petersen ET) compared to other designs. Most data for this design is available only for the cemented version. Up to now there is no safety study performed that confirms the stability over time for this implant with cementless fixation.

In this study, the investigators will therefore analyze the in vivo stability of an uncemented TKA with a medially stabilized design, and compare it with a well-documented comparable implant. In order to do this, the investigators will use the CT based micromotion analysis (Broden C, Broden C). This study will contribute to the understanding of fixation and lead to safety to the patient.

Eligibility Criteria:
Inclusion Criteria:

• Patients referred to Kristiansund Hospital for primary total knee replacement surgery for osteoarthritis with Kellgren \& Lawrence grade 3 or 4

Exclusion Criteria:

* Preoperative severe deformity (Hip-Knee-Ankle angle of \>5 (valgus) or \<-15 degrees (varus) on a full-length leg image at weight bearing
* Preoperative flexion contracture more than 15°
* Less than 50 and more than 75 years of age at the time of surgery
* Use of walking aids because of other musculoskeletal and neuromuscular problems
* Preoperative diagnosis other than osteoarthritis or avascular necrosis (e.g. rheumatoid arthritis, tumours)
* Revision arthroplasty
* Obesity with BMI\>35 g/m2
* Lateral collateral ligament deficient knee
* Previous knee joint infection
* Cognitive dysfunction or severe psychiatric disorders.
Blood Pressure Response to Sodium in the Diet

Previous studies have demonstrated that single nucleotide polymorphisms (SNPs) of the sodium-bicarbonate co-transporter gene (SLC4A5) are associated with hypertension. We tested the hypothesis that SNPs in SLC4A5 are associated with salt sensitivity of blood pressure in 185 whites consuming an isocaloric constant diet with a randomized order of 7 days of low sodium (Na+) and 7 days of high Na+ intake. Salt sensitivity was defined as a ≥7-mm Hg increase in mean arterial pressure during a randomized transition between low and high Na+ diet.

A total of 35 polymorphisms in 17 candidate genes were assayed, 25 of which were tested for association. Association analyses with salt sensitivity revealed 3 variants that associated with salt sensitivity. Of these, 2 SNPs in SLC4A5 (rs7571842 and rs10177833) demonstrated highly significant results and large effects sizes, using logistic regression. These 2 SNPs had P values of 1.0×10-4 and 3.1×10-4 with odds ratios of 0.221 and 0.221 in unadjusted regression models, respectively, with the G allele at both sites conferring protection. These SNPs remained significant after adjusting for body mass index and age (P=8.9×10-5 and 2.6×10-4 and odds ratios 0.210 and 0.286, respectively). Furthermore, the association of these SNPs with salt sensitivity was replicated in a second hypertensive population. Meta-analysis demonstrated significant associations of both SNPs with salt sensitivity (rs7571842 \[P=1.2×10-5\]; rs1017783 \[P=1.1×10-4\]).

In conclusion, SLC4A5 variants are strongly associated with salt sensitivity of blood pressure in 2 separate white populations.

Subjects are placed on an isocaloric diet, one week with high sodium(300mEq) and one week with low sodium(10mEq), in randomized order. Twenty-four hour urine sodium and urine creatinine levels verify diet compliance. Blood pressure measurements are recorded during each diet week by automated blood pressure monitoring system. Each blood pressure is taken in the right arm 3 times while the subject is sitting quietly for 45 minutes .

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-70 (inclusive)
* Sex Male and female
* Race Caucasian and African-American/black
* BMI 18.-0-29.9
* BP Normal

Exclusion Criteria:

* hypertension
* blood pressure \> 140/90 mmHg
Empagliflozin in Heart Failure Dialysis Patients

Empagliflozin is not still approved for glomerular filtration rate \< 20 cc/min/1.73m2. Considering the cardiac and renal benefits of this drug, the evaluation of the safety and efficacy of Empagliflozin for heart failure dialysis patients seems to be mandatory.

Heart failure dialysis patients with residual renal function will be followed up on Empagliflozin based on echocardiographic parameters, pro-brain natriuretic peptide levels, diuresis volume, and serum acidity.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure on dialysis with residual renal function

Exclusion Criteria:

* Dialysis patients with no residual urine
Study to Evaluate the Impact of the Use of Alternative and Complementary Therapies on Therapeutic Adherence in Patients Treated With taMoxifen for Early Stage Breast Cancer

This is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer.

200 patients will be included in the study.

Each patient will be followed for one day.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at entry into the study.
2. Patient treated for hormone-dependent localized breast cancer requiring adjuvant Hormonal Therapy (HT) with tamoxifen.
3. Patients treated with tamoxifen for a maximum of 1 to 3 years.
4. Patient affiliated with a Social Security system in France.
5. Patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Any psychological, family, geographical or sociological condition that does not allow the medical follow-up and/or the procedures foreseen in the study protocol to be respected.
3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Acute Effect of Animal and Vegetable Protein Rich Meals With Comparable Dietary Fibers Content on Appetite Sensation and Energy Intake

Background:

* New Nordic diet guidelines advocate a reduction in consumption of protein from animal sources such as beef and pork, due to environmental concerns.
* Instead, intake of protein from vegetable sources such as legumes and pulses should be increased.
* A previous study showed that a meal enriched with vegetable protein increased the subjective sensation of satiety and decreased hunger and ad libitum energy intake (EI) compared to animal protein.
* This study did, however, not document that vegetable protein per se is more satiating than animal protein as the vegetable meal had higher fiber content. Fiber is a likely confounder.
* The protein from egg is sparingly investigated in relation to appetite. Few studies have found that eggs have a high satiety index but further investigation is needed.

Objective:

- To examine if vegetable protein (beans and peas) can suppress subjective appetite (VAS and ad libitum energy intake) compared to isocaloric meals enriched with either red meat or egg with similar distribution of macronutrients and content of dietary fibers.

Design:

Single-blind randomized 4-way crossover meal study

Subjects:

33 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2). Expected completers: n=30.

End points:

1. Subjective appetite (VAS) (every 30 min for 3 hours)
2. Ad libitum EI (3 hours after lunch test meal)


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI: 18.5-30.0 kg/m2
* Weight stable (within +/- 3 kg) two months prior to study inclusion,
* Non-smoking
* Nonathletic (\< 10 h hard physical activity)

Exclusion Criteria:

* BMI \> 30 kg/m2
* Change in smoking status
* Daily or frequent use of medication that can affect appetite
* Suffering from metabolic diseases
* Suffering from psychiatric diseases
* Suffering from any other clinical condition, which would make the subject unfit to participate in the study
* alcohol and drug abuse
* food allergies or relevance for the test meals
Electronic Platform for Diabetic Patients Activation

The purpose of this study is to assess the efficacy of an electronic platform for doctor-patient communication in order to reduce severe and non-severe hypoglycemia events as well as inadvertent hypoglycemia events.

This is an open randomized clinical trial without drugs. Patients with type 2 diabetes and treated with insulin will be included. Patients allocated in the intervention group will use the electronic platform as a communication channel with their health provider during the time between visits.

The name of the platform is ti.care (https://ti.care/es) and it will be a complement of the control visits to resolve doubts through chats, email or video call. Health providers will answer the patient requests.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 17 years
* Patients with type 2 diabetes diagnosis
* Patients who start insulin treatment or with intensification of treatment
* Patients who sign informed consent

Exclusion Criteria:

* Patients with type 1 diabetes diagnosis
* Life expectancy less than one year
* Pregnancy
* Patients with dementia
* Patients with treatment different to insulin
* Patients who, in the opinion of the researcher, cannot follow the recommendations of the self-care health education plan.
Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)

Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially. However, even after a procedural success there is a high risk of recurrence, particularly due to the inability to create transmural lesions. Indeed, only the endocardium of the LV has been ablated, while a significant part of the arrhythmia substrate may be located on the other side of the myocardial thickness, on the epicardial side of the LV.

First described in 1996, epicardial ablation, performed via a percutaneous subxyphoid approach, has since undergone considerable development. Electrophysiologists often use a double endo- and epicardial approach as first line therapy for the ablation of VTs complicating myocarditis or arrhythmogenic dysplasia of the right ventricle, where the substrate is most often epicardial.

For VT in ischaemic heart disease, electrophysiologists perform endocardial ablation, and often perform epicardial ablation only after several endocardial failures. Several observational studies suggest that a combined endo- and epicardial approach as first line therapy is associated with a reduced risk of VT recurrence. Since recurrent VT in patients with ischaemic heart disease as a prognostic impact in terms of morbidity and mortality, it appears essential to optimise rhythm management by ablation, by offering a combined approach from the as first approach to reduce the risk of recurrences.

The aim of our prospective, multicentre, controlled, randomized study is therefore to compare the rate of VT recurrence after ablation performed as first line therapy either by endocardial approach alone or by combined endo-epicardial approach.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age
2. 1st radiofrequency ablation of VT complicating ischaemic heart disease
3. Patients with an ICD and remote monitoring
4. Having, for women of childbearing age, effective contraception until discharge from hospital
5. Have given their free and informed consent in writing
6. are affiliated to or have health insurance

Exclusion Criteria:

1. History of cardiac surgery compromising the epicardial approach (coronary artery bypas s grafting, valve replacements, or other surgeries that may have caused pericardial adhesions)
2. Anticoagulant therapy that cannot be temporarily discontinued
3. Double antiplatelet therapy that cannot be temporarily replaced by single antiplatelet therapy
4. History of pericarditis
5. Previous thoracic radiotherapy
6. Contraindication to general anaesthesia
7. Pregnant or breastfeeding woman
8. History of heparin-induced thrombocytopenia type 2 (as injection is required during the procedure)
9. Person under legal protection (safeguard of justice, curatorship, guardianship), deprived of liberty, or unable to express consent
Antibiotic Resistance in Danish EDs.

The spread of multiresistant bacteria is an increasing problem which will mean increased costs, morbidity and mortality in the coming years. Emergency departments (ED) play a key role in the early identification and management of patients who are carriers of multiresistant bacteria, but today there is very limited knowledge about both prevalence in the EDs and risk factors for the carrier status of methicillin resistant Staphylococcus aureus (MRSA), extended spectrum beta lactam producing enterobacteria (ESBL), vancomycin resistant enterococci (VRE), carbapenem resistant enterobacteria (CPE) and toxin-producing Clostridium difficile (CD). This knowledge is necessary to prioritize and target the preventive response to the spread of multiresistant bacteria.

The aim of this project is to provide a comprehensive overview of prevalence and risk factors for carrier status at a national level, and to develop screening tools for early identification of MRSA, ESBL, VRE, CPE and CD carriers among patients admitted to Danish emergency departments.

For hospitalized patients in 8 emergency departments in 4 Danish regions, a total of 10,600 patients are asked for possible risk factors for resistant bacterial carrier status, and are swabbed in the throat, nose and rectum openings and examined for MRSA, VRE, CPE, ESBL and CD with the same analytical method of 4 clinical microbiological departments.

The results are analyzed so that the prevalence of resistant bacteria can be described at the hospital level, regional level and national level. Risk factors are analyzed for applicability for carrier identification, and based on this, screening models for the identification of carriers are developed.

The vision for the project is that, based on the collected data, a comprehensive picture of the extent of the problem in Denmark can be drawn up and new screening tools for early identification of carriers can be developed so that the intra-hospital spread of resistant bacteria can be met through early intervention with infectious hygiene measures.

The project has been granted a grant of DKK 3,000,000 from the Ministry of Health and the Elderly on December 7, 2016 and DKK 554,871 from the Region of Southern Denmark on 28 August 2017.


Eligibility Criteria:
* Must be over 18 years
* Must be admitted to one of the emergency departments selected for the project for more than 4 hours.
* Must be mentally competent
* To consent to participate

Exclusion Criteria:

* admitted more than 16 hours before inclusion
* no operation in rectum less than 2 weeks before the admission
Evaluation of Non Specific Symptoms and Quality of Life Before and After Surgery for Mild Primary Hyperparathyroidism

The purpose of this study is to evaluate the evolution of the non specific symptoms for 116 patients with mild primary hyperparathyroidism before and 3, 6 and 12 months after surgery. A clinical score predicting clinical improvement at one year will be created.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with known moderate HPTI will be considered for participation.

Patients with sporadic mild HPTI defined by:

* calcemia \> 2.6 mmol/L , PTH \> 25 ng/L and creatininemia \< 160µmol/L OR
* calcemia between 2.5 and 2.6 mmol/L and PTH \> 35 ng/L
* calcemia ≤2.85 mmol/L
* urine calcium level / 24 hours \< 10 mmol (400 mg),
* decrease of the creatinin's clearance : 30% lower than normal population with the same age
* patients younger than 50
* patients who can't be followed

Exclusion Criteria:

* familial hypercalcemia
* multiple endocrinal neoplasia
* treatment with lithium or thiazides
* impossibility for the patient to complete the forms
* impossibility to follow the patient
* patient with serious disease which impact the quality of life