cyrilzakka/clinical-trials huggingface dataset:
Orientation for Hearing Aid Users: Information Retention

Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this

Introduction: The understanding and retention of orientations provided by the health professional increases patient's satisfaction and compliance to treatment and reduces treatment duration and costs. Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this. Methods: Participated in this study 30 adults (18 female and 12 male) with age varying from 18 to 88 years, with post lingual uni or bilateral hearing loss of various degrees and types. Orientations were offered at the time of diagnosis and hearing aid fitting. At the first follow up visit patients were interviewed regarding their hearing loss' characteristics as well as hearing aid care and use (probed recall task). It was also evaluated how participants manipulated their devices. A protocol was used to score participant's responses. Results: on average participants could retain 31,6% and 83,6% of the orientation provided regarding their hearing loss and hearing aid care and use. There was a negative correlation between age and amount of information retained. There was no influence of degree of hearing loss, academic and socio-economic statues. Conclusion: The hearing impaired patients have difficulty to recall orientation provided therefore the use of facilitation strategies to information retained is necessary.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years old
* sensorineural hearing loss, hearing aid candidate

Exclusion Criteria:

* severe dexterity or visual problems. Cognitive or memory disorders
Exploratory Study of Molecular Characterization in Patients With Metastatic Germ Cell Tumours Refractory/Resistant to Platinum Treatment

1. To establish whether circulating tumour DNA is detectable in the plasma of patients with platinum refractory/resistant Germ Cell Tumours
2. If ctDNA is detectable, perform exploratory analyses to:

   1. Describe the molecular aberrations in plasma from metastatic GCTs with platinum refractory/resistant disease
   2. Describe aberrations detected in sequential detected in sequential samples form the same individual patient and evaluate whether there are hyposthesis-generating changes that temporarily associate with clinical resistance.

This project will study the plasma of patients who have metastatic GCTs with platinum refractory/resistant disease in order to establish if ctDNA is detectable and then analyse the molecular aberrations. Archival diagnostic tissue will be recalled (this is the tissue used to make the initial diagnosis of testicular cancer). Excess tissue acquired from clinically mandated prospective biopsies will be stored and plasma which has been collected at a maximum of 15 time-points per year will be analysed. Clinical data will be accessed to make clinically meaningful associations with plasma and tissue molecular aberrations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed metastatic GCT refractory/resistant to platinum treatment
* Patients who have signed the 'Tissues for Research' consent form at the Royal Marsden Hospital and have blood samples stored in the RMH Biobank.
* Patients with no prior or current non-testicular invasive malignancy within the last 3 years, other than non-melanoma skin cancer or NCCN low risk prostate cancer (pT1 or pT2a Gleason ≤ 6, PSA ≤ 10 and ≤ 1cc total volume)

Exclusion Criteria:

* n/a
Evaluation and Monitoring of the Protocol Post Operative Atrial Fibrillation

Objectives The aims of this study is to evaluate the efficacy and tolerance of our post-operative AF management protocol after cardiac surgery, including beta-blockers, digoxin, amiodarone.

Methods This study concerns patients From brest university Hospital who underwent cardiac surgery between November 2019 and November 2021. Patients with a previous history of atrial arrhythmias were excluded. The primary endpoint is assess effectiveness of service protocol to maintain cardiac frequency below. 110 bpm. The secondary endpoints included hemodynamic tolerance and outcomes.

Background Atrial fibrillation (AF) is the most common complication after open heart surgery. Its reported incidence is about 30%, and it is associated with a significant increase rate of thromboembolic events, respiratory failure, a longer lenght of stay in hospital and mortality. (1 ;2) Gillinov's study has shown equivalent effectiveness of a rhythm control and rate control strategy, in AF patients after cardiac surgery, with increased side effects in patients treated with rhythm control agents. (3) The introduction of beta-blockers can be poorly tolerated hemodynamically in patients hospitalized in intensive care unit, unless untroducing a cardio-selective beta-blocker..

Methods Patients who underwent a cardiac surgery from Novembre 2019 to Novembre 2021 were included. Patients with a previous history of atrial arrhythmias were excluded. The primary endpoint is assess effectiveness of service protocol to maintain cardiac frequency below. 110 bpm. The secondary endpoints included hemodynamic tolerance and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* POAF after cardiac surgery non-opposition formulated

Exclusion Criteria:

* pregnant woman opposition hemodynamic unstability with inotropic drugs or CI\<2 L/min/m2
Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in Management of Periodontal Intrabony Defects

A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in comparison with open flap debridement for management of periodontal intrabony defects.

Thirty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched two- or three-walled intrabony defects. Patients were equally assigned into the experimental group; Nano-crystalline hydroxyapatite silica gel or the negative control group;open flap debridement. Clinical and radiographic parameters were recorded at baseline and at 3 and 6 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Severe chronic periodontitis patients.
* having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs.

Exclusion Criteria:

* Pregnant women
* Subjects had \<22 permanent teeth
* Having any given systemic disease
* Taking any type of medication and/or antibiotic therapy during the 3 months before the study
* Received periodontal treatment within the past 12 months Current or former smokers
Effects of Whole Egg Consumption on Inflammation, Mood, and Recovery in Collegiate Female Gymnasts

The objectives were to investigate the effects of whole egg consumption by collegiate female gymnasts on inflammatory markers, mood, and recovery.


Eligibility Criteria:
Inclusion Criteria:

* Membership on the university gymnastics team

Exclusion Criteria:

* egg allergies, asthma, coronary artery disease, depression, diabetes, hypertension, migraines, cancer or cancer-related complications, or auto-immune disorder
Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity

Bacille Calmette-Guerin (BCG) is a live attenuated vaccine administered for prevention of tuberculosis. Recently, several groups have hypothesized that BCG may "train" the immune system to respond to a variety of unrelated infections, including viruses and in particular the coronavirus responsible for COVID-19. Trials are currently being conducted in Australia, Netherlands, Germany and the United Kingdom to evaluate its effectiveness.

Front line workers includes members of municipal and provincial police services, emergency medical personnel, firefighters, public transport employees, health service workers and food manufacturing employees. They are at high risk of infection from COVID-19, with potentially high infection rate. The investigators propose an interventional trial to evaluate the effectiveness of BCG vaccination to prevent COVID-19 infection and reduce its severity in front-line employees in Ontario.


Eligibility Criteria:
Inclusion Criteria:

* Eighteen years of age or older
* Employee/member of: municipal or provincial police service, emergency medical services, fire services, public transport service, health service, food manufacturing facility

Exclusion Criteria:

* Prior intravesical BCG or intradermal BCG, with the exception of tuberculosis vaccination in childhood.
* Previous known history of latent or active tuberculosis
* Known kidney, liver or blood disorders which impairs organ and marrow function
* Chronic administration of steroids (\>10 mg prednisone) at the time of randomization
* Current or planned concomitant biologic therapy in the next 7 months.
* Known hypersensitivity or allergy to components of VPM1002
* Pregnant or planning to become pregnant in the future 7 months.
* Breastfeeding.
* Current suspected viral or bacterial infection.
* Body temperature \> 38° C
* Participation in another interventional study with potentially conflicting medication within 30 days before screening.
* The presence of an impaired immune response irrespective of whether this impairment is congenital or caused by disease, drugs or other therapy (e.g., anti-TNF therapy, methotrexate, azathioprine, antimalarials).
* Active malignancy requiring treatment.
* Known positive HIV serology.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to BCG vaccine.
* Previous positive COVID-19 confirmed infection.
* Uncontrolled intercurrent illness.
* Psychiatric illness/social situations that would limit compliance with study requirements.
Molecular Phenotypes for Cystic Fibrosis Lung Disease

The purpose of this study is to develop an integrated view of molecular mechanisms underlying CF lung disease severity.

BACKGROUND:

Cystic fibrosis (CF) is a recessive genetic disorder caused by mutations in CF transmembrane conductance regulator (CFTR) gene. CF has multi-organ involvement, but respiratory disease is the major cause of morbidity and mortality. The median age of survival in CF is only 37 years, but there is a broad range of disease severity in the lung, even among patients with identical CFTR genotypes, including deltaF508 homozygotes.

DESIGN NARRATIVE:

This project holds great promise for defining a robust molecular phenotype for CF lung disease, which relates to prognosis, and new targets for therapy. By using a large and well-defined population of deltaF508 homozygotes who also have whole genome single nucleotide polymorphism (SNP) data, and by studying gene expression across the whole transcriptome in a large number of samples of two relevant tissues (respiratory epithelium and transformed lymphocytes), we will be uniquely positioned to develop an integrated view of molecular mechanisms underlying CF lung disease severity.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with CF
* Participation in Genetic Modifiers of CF Lung Disease study (NCT00037765)

Exclusion Criteria:

* History of lung transplant
* Fully anticoagulated or clotting abnormalities
* Large nosebleed in the last 2 months
* Acutely ill
The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori

The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori). Through checking various parameters including anthropometric, antioxidants, and CDR.

The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori).

Preclinical studies (In vitro model) were conducted using 3T3-L1 adipocyte cells to check the anti-adhesion activity of BR.

For the clinical trial, a total of 21 obese mild AZ patients were recruited and separated into 2 groups: Experimental (BR group) and Placebo group.

Experimental group and Placebo group subjects were requested to take either 50 g of BR or 50 g of dextrin respectively for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≧ 27, Waist circumference: men ≧ 90cm, women ≧ 80cm,
* Body fat: male ≧ 25%, female ≧ 30%,
* UBT 13C test value\> 10‰ (H. pylori (+)),
* CDR (clinical dementia rating) = 0.5

Exclusion Criteria:

* BMI\< 27
* Severe chronic diseases (liver disease, cardiovascular disease, kidney disease)
* Alcohol abuse
* Smoking habit
* Taking berry-related supplementation or any known allergies related to berries.
* Subjects with prior history of H. pylori infection were treated with triple therapy.
Caffeine in the Prevention of Post-operative Nausea and Vomiting

The objective of this study is to determine if caffeine 500 mg intravenously is efficacious when added to standard anti-emetic prophylaxis in the prevention of post-operative nausea and vomiting (PONV) in patients undergoing ambulatory surgery under general anesthesia.

This is a prospective, randomized, double-blind, placebo-controlled study of caffeine, 500 mg, intravenously, in addition to standard anti-emetic prophylaxis, in the prevention of post-operative nausea and vomiting in patients undergoing ambulatory surgery under general anesthesia.

Consenting patients will be randomized to receive either a single dose of caffeine, 500 mg, or saline placebo, administered as a single IV dose approximately 15 minutes before emergence from anesthesia. All patients will receive our customary anti-emetic prophylaxis, determined by four major risk factors for PONV: female gender, nonsmoking status, history of PONV or motion sickness, and perioperative opioid use. Patients at low risk for PONV (no risk factors) will receive no prophylaxis; patients at moderate risk for PONV (1 or 2 risk factors) will receive dexamethasone 8 mg at induction plus dolasetron 12.5 mg approximately 15 min before the end of anesthesia; patients at high risk for PONV (3 or 4 risk factors) will receive the same treatment as those at moderate risk, plus additional prophylaxis at the discretion of the attending anesthesiologist (e.g., scopolamine patch, metoclopramide 10 mg IV, or other standard drugs).

Postoperatively, the presence of PONV will be recorded. If rescue medication is used, the amount and time of administration will be recorded. The length of stay in the PACU (Phase I and Phase II) will be recorded. Patients will be asked to report any headache, and to rate their nausea, pain, alertness, fatigue, and overall satisfaction in the PACU, and again by phone 24 hours postoperatively. Amount of pain medication utilized in the PACU will also be measured.

Eligibility Criteria:
Inclusion Criteria:

* Patient having ambulatory surgery
* Patient receiving general anesthesia

Exclusion Criteria:

* Patient is not willing to sign informed consent
* Patient does not speak or understand sufficient English
Nutritive Sucking Patterns in Premature Infants

In this pilot trial, the investigators will determine the feasibility of monitoring nutritive sucking patterns to facilitate the transition from tube to oral feeding in extremely-low-birth weight (ELBW) infants

In this parallel-group randomized controlled trial, ELBW infants (birthweight \< 1000 grams) will be randomly assigned in a 1:1 ratio to either weekly reporting on objective measurements of sucking activity during oral feeding (intervention group) or usual care without information on sucking activity (control group).

Eligibility Criteria:
Inclusion Criteria:

* Birthweight \< 1000 grams
* Gestational age \< 32 weeks of gestation
* Full enteral feeding established before or on postnatal day 21
* Oral feeding initiated before or at 33 weeks of postmenstrual age

Exclusion Criteria:

* Major congenital/chromosomal anomalies
* Patent ductus arteriosus causing significant cardiovascular symptoms
* History of necrotizing enterocolitis stage 2 or greater
Safety Skills Training: Parents of School-Aged Children

Injuries are the leading cause of death and disability in children in America. Most injuries can be prevented when parents implement effective child safety practices. This project will create a behaviorally based program to teach parents what to do to prevent injuries to their school aged child, in an effort to reduce the number of injuries, hospitalizations, medical costs, and missed work days.

This project will produce a comprehensive, interactive multimedia (IMM) program to teach childhood injury prevention skills to parents of children 6 through 11 years of age. This is one of a four-part series of funded programs to address injury prevention issues for three age groups of children (birth through 24 months, 2-5 years of age and 6-11 years of age). The program will be created in three formats: Internet/intranet, CD-ROM, and linear video (DVD) suitable for use in homes, worksites, medical settings, service agencies, and health information Web sites. On-screen narrators will guide the user through program material comprised of short video presentations, modeling vignettes demonstrating desired behaviors, supportive testimonials, and suggestions for modifications to home and recreational environments.

Eligibility Criteria:
Inclusion Criteria:

* The basic lower age limit for parents or guardians of children aged 6-11 for this study was 18. Parents or legal guardians could potentially be as old as 65 or older.

Exclusion Criteria:

* Only English-speaking participants were accepted because the program was developed only for English speakers. All English-speaking parents or guardians living in the U.S., with children aged 6-11 years old, who wished to participate were included. Parents under 18 were excluded from this online study because parental consent cannot be obtained online.
Frailty Assessment by Edmonton Frail Scale to Predict Outcome in Patients Undergoing Cardiovascular Surgery

The aim of the study is to assess frailty of patients admited for cardio-vascular surgery in Cliniques Universitaires Saint Luc in Brussels. And analyse the correlation between frailty, functionnal decline and postoperative mortality.

Frailty is a state of loss of functional reserve resulting in an increased vulnerability to a stressor event. From a pathophysiological point of view, it is an accelerated decrease in physiological reserve related to ageing.

Currently, evaluation of the outcome after cardiac surgery is commonly based on scores not taking into account the concept of frailty (Society of Thoracic Surgeons (STS) and Eurosore II) Recent studies have shown an independent association between post cardiac surgery mortality and pre-operative frailty. Beyond cardiac surgery, frailty has been shown to be associated with higher mortality and morbidity among intensive care unit (ICU) patients. Frailty is commonly assessed for patients older than 75 years of age but the prevalence in younger patients admitted to the hospital is significant. There is therefore need to evaluate all patients for frailty in the preoperative period.

Since the Edmonton Frail Scale (EFS) allows easy screening of all frailty domains, we hypothesized that it could be a reliable and feasible score to assess preoperative frailty and to predict postoperative morbidity and mortality.

Objectives:

The primary objective of this study is to evaluate preoperative frailty in all adult patients undergoing cardiac and vascular surgery.

The secondary objectives are:

* to evaluate the association between frailty and postoperative mortality.
* to evaluate the association between frailty and postoperative functional decline (nursing home admission or care dependency)
* to evaluate impact of each frailty domain on the post-operative outcomes (mortality and functional decline)
* to evaluate how to integrate frailty with the others preoperative clinical parameters to better predict postoperative outcome

Measurement:

Assessment of frailty will be performed using EFS. Other clinical conditions related to frailty will be collected: Body Mass Idex (BMI), tobacco use, alcohol consumption, preoperative albumin and pre-albumin level. STS and Eurosore II will be systematically calculated.

A one-year follow-up will assess the following parameters:

* all-cause mortality
* functional decline with admission to a nursing home or care dependency. Care dependency will be defined by a Katz index more than 0 \[19\].

Follow-up will be realized by a phone call to the patient, his relatives or his general practitioner.

Based on a prevalence of frailty of 11%, we have determined that the enrollment of a minimum of 2080 patients would provide a power of 80% at a significance level of 5% to detect a difference of 5% mortality at one year between frail and non-frail patients.

Eligibility Criteria:
Inclusion Criteria:

* Any cardiac surgery under cardiopulmonary bypass
* Any vascular surgery

Exclusion Criteria:

* Salvage surgery
* Cirrhosis CHILD B or C
The Efficacy β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists

A double-blind, placebo-controlled, randomised, with two arms (product and placebo) unicentric clinical trial to analyse the efficacy on physical performance parameters of a product designed for sport during a lapse of two weeks (7 days).

After recruitment, subject will be randomised and allocated to one group of the 2 study arms: treatment group or control group (placebo).

A simple randomisation will be performed using software by a random number generator, and assigned to participants.

Eligibility Criteria:
Inclusion Criteria:

* Not respecting rest the day before physical tests.
* Not being in a fasted state (at least 2 h from last meal).
* Having consumed stimulants acutely before the trial, or under drug treatment affecting perceived effort of the trial.
* Not being available to perform every trial on the same conditions at the same time of the day.
* Not sticking to the same diet, 24 h before each trial.

Exclusion Criteria:

* Adverse event
* Protocol violation
* Lost to follow-up
* Allergy to any of the components of the treatment or placebo product. This includes allergy to β-alanine, wheat, soy, nuts (including peanuts), sesame and its byproducts.