cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial

The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).


Eligibility Criteria:
Key Inclusion Criteria:

* Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator system, per local directions for use (DFU).
* Subject signed a valid, EC/IRB-approved informed consent form.
* Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law when written informed consent is obtained.
* In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain.

Key Exclusion Criteria:

* Subject meets any contraindication in BSC neurostimulation system local DFU.
* Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy.
* Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information.
* Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments.
Disulfiram as a Modulator of Amyloid Precursor Protein-processing

A causal therapeutic approach for treatment of Alzheimer's disease has not been established so far. The protein ADAM10 represents a promising target for an A-beta peptide preventing strategy. Treatment of human neuronal cells with Disulfiram, a drug which is used in clinical routine for recrudescence prevention of alcohol dependency, revealed an increased expression of ADAM10. This finding indicates a neuroprotective potential of Disulfiram. The investigators' research purpose aims at the verification of the results obtained in cell culture experiments in the human organism. Therefore, include alcohol addicted patients were included, which take the drug Disulfiram for recrudescence prevention, in our study. Patients are recruited from the patient-collective of the University Medical Center Mainz and the Central Institute for Mental Health Mannheim. Blood samples (max. 5 ml) are taken from the participants before the intake of Disulfiram and about two weeks after treatment. Demographic data are collected (such as age or onset of addiction). Gene expression is analyzed via reverse transcription polymerase chain reaction(RT-PCR) from blood cell-derived messenger ribonucleic acid (mRNA).


Eligibility Criteria:
Inclusion Criteria:

ambulant or stationary patients, which receive Disulfiram for recrudescence prevention

Exclusion Criteria:

Diagnosed Alzheimer's dementia Previous Disulfiram treatment less than four weeks before baseline blood collection
Efficacy of Philips Sonicare Flexcare Platinum Toothbrush® Compared to Manual Brushing in Healthy Patients: a 1 Year Follow up

Professional oral hygiene has become a customary procedure in everyday dentistry. Both manual and sonic brushes are part of normal oral hygiene education practice. Compared with manual toothbrushes, ergonomic instruments, such as sonic toothbrushes, can be a more practical and less demanding mean to remove biofilm and plaque efficiently. Studies in literature investigate the efficacy of toothbrushes in plaque removal, but the investiagator's study would validate efficacy of toothbrushes post-causal therapy, towards lower plaque accumulation, and reduction in bleeding.

The objective of this study is to compare two methods (manual VS sonic) of tooth brushing in terms of impact on the gingival index and plaque index after one session of Full Mouth-Erythritol Powder Air Polishing Therapy (FM-EPAPT) in healthy patients.

The hypothesis of the present randomized controlled trial is that sonic tooth brushing accumulates less plaque (-10%) than manual tooth brushing.

To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups and, after a session of professional oral hygiene, will be instructed to use:

* CONTROL: manual toothbrush
* TEST: sonic toothbrush. Gingival index and plaque score will be evaluated at 2, 4, 6 weeks and 6 and 12 months.

Everyone's goal to have a healthy mouth is the removal of biofilm, plaque and calculus from the dental surface everyday. Moreover routine recalls ensure a better oral health and greater protection against caries, gingivitis and periodontitis. Regular attendance to oral hygiene sessions plays an important role but has to be accompanied by the compliance with home oral care instructions. The patients should be adequately instructed to take care of their oral health.

TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of parallel design.The trial will have one-year duration.

STUDY POPULATION: Healthy subject affected by gingivitis are included in the study. Presence of gingivitis is defined as bleeding on probing (BOP) \> 25%.

PRIMARY OUTCOME: Change in Plaque Index (PI): change in 10% less of the site in test group.

SECONDARY OUTCOME:

* Change in Gingival Index (GI): change in presence or absence of bleeding after gently run on the surface of the marginal gingiva.
* Change in Recession (REC): change in gingival reduction.
* Change in Clinical Attachment Level (CAL): change in clinical attachment level.

Eligibility Criteria:
Inclusion Criteria:

* Patients affected by gingivitis is defined as bleeding on probing (BOP) \> 25%.
* Healthy young patients (18-40 years)
* Patients with almost 5 teeth per quadrant
* Patients smoking less than 10 cigarettes a day

Exclusion Criteria:

* Presence of periodontitis (pocket depth - PPD \> 4 mm)
* Patient with BOP and/or plaque index \< 25%
* Patient with any systemic disease
* Orthodontic or prosthesis patient
* Patient with split
* Impossibility to come to the recall appointments
* Not willing to follow the agreed protocol
Heart Rate Variability (HRV) Testing Compared With Exercise Stress Test in Hospitalized Patients With Chest Pain

There are many patients hospitalized for chest pain, which don't have high risk features that require invasive coronary angiography, but are considered intermediate risk and for which ischemic heart disease can not be excluded.

The current management for these patients is to perform a non invasive test in order to classify their risk.

Exercise ergometry is a commonly used non invasive test to detect ischemia. that test is non-invasive, and does not involve radiation or intra-venous contrast. The test is limited for many patients, because of un-ability to exercise, or because of non-interpetable Electro Cardio-Graphy (ECG).

Heart rate variability is well known to be a marker of ischemic heart disease. Heart rate variability testing is a non-invasive ECG monitoring technique.

The study design is to identify hospitalized patients who are candidates for non-invasive stress testing, and to monitor their heart rate variability for one hour prior to the stress test.

Ischemic heart disease is among the leading causes of death and disability in the modern world. Effective treatment for cardiac ischemia is based on identification of the proper patients and assigning prompt treatment to those patients.

It is not simple identifying the proper patients. There are many patients complaining of typical anginal chest pain without coronary heart disease, and there are many patients with active angina who complain of non-typical symptoms or who don't feel any symptoms.

Management of hospitalized patients with suspected angina pectoris is based on their complaints, their risk factors and laboratory results (ECG, troponin). They are classified into low-risk, high risk and intermediate.

Intermediate risk patients usually require additional testing in the hospital in order to re-classify them into high or low risk.

Heart rate variability is a well-known marker of active cardiac ischemia. The investigators plan to perform a 60 minute heart rate variability monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Hospitalized for Chest pain
* Intermediate probability for ischemic heart disease
* Selected management strategy is non invasive cardiac stress testing

Exclusion Criteria:

* Active Ischemic symptoms
* ECG changes suggestive of myocardial ischemia
* Troponin elevation on blood tests
* Atrial flutter
* Multiple APB's or VPB's on resting ECG
Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)

This study aims to clarify, in patients with more or less abundant pericardial effusion in the acute phase of a myocardial infarction, the correlation between the existence of this effusion during the acute phase with clinical parameters, biological, angiographic, therapeutic and with transmurality, extent, microvascular obstruction and intra myocardial hemorrhage found on MRI made beyond one week and before the 3rd month of the constitution of the necrosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 and 90 years old
* Patient admitted to the acute or semi-recent phase (within the next fifteen days) of a myocardial infarction (primary or recurrent myocardial infarction) documented by a significant enzymatic release of troponin (threshold value at 100) in the course of: chest pain or shock, or flare-up of heart failure (left or global) or successfully resuscitated cardiac arrest, or paroxysmal ventricular arrhythmia with or without sus shift of the ST segment on the input trace, with or without Q wave of necrosis formed. This IDM may or may not be complicated by a more or less abundant pericardial effusion of more than 10 mm in the left parasternal, which may in the extreme be the cause of tamponade;
* Subject affiliated or beneficiary of a social security scheme;
* Patient having signed the free and informed consent.

Exclusion Criteria:

* Patient with a pericardial detachment of less than 10 mm, or only systolic;
* Patient who had a break-in during the primary angioplasty guide or complicated coronary dissection extravasation with secondary pericardial effusion;
* Patient with advanced chronic renal failure
* Patient unable to perform an MRI (with a defibrillator or pacemaker).
* Known allergy to contrast agents, in particular gadolinium
* claustrophobic patient;
* Protected patient: adult under guardianship or other legal protection, deprived of liberty by judicial or administrative decision;
* Pregnant or breastfeeding woman;
* Patient hospitalized without consent.
Assessing the Minimal Important Difference (MID) of the Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD)

This study is conducted in the United States of America (USA). The aim of the study is to assess the minimal important difference (MID) of the TRIM-AGHD.


Eligibility Criteria:
Inclusion Criteria:

* Able to speak read and write English
* GHD (Growth Hormone Deficiency) treatment naïve which is defined as not being on a prescription treatment for their GHD currently and for at least 6 months
* Beginning a new prescription GHD treatment and expected to be on this treatment for GHD for a minimum of 6 months
* GHD of either one of the following criteria: a) Adult onset: subjects who have GHD, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or traumatic brain injury (TBI), b) Childhood Onset: Subjects who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes
* Confirmed diagnosis of growth hormone deficiency (if a subject satisfies any one of the three following criteria): a) For the insulin tolerance test (ITT) or glucagon test both performed within the last five years: the validated cut-off for GHD in adults is a peak GH response of below 3.0 ng/mL (3 microg/L), b) For growth hormone releasing hormone (GHRH) +Arginine test performed within the last five years: for those subjects with a body mass index (BMI) below 25 kg/m\^2, a peak GH below 11 ng/mL (microg /L); for BMI 25-30 kg/m\^2, a peak GH below 8 ng/mL (8 microg/L); for BMI above 30 kg/m\^2, a peak GH below 4 ng/mL 341 (4 microg/L ), c) Three or more pituitary hormone deficiencies at screening
* Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol)

Exclusion Criteria:

* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
* Patients who have been on a prescription medication for treatment of GHD in past 6 months
* Patients with a total Beck Depression Inventory II (BDI-II) score greater than 25
* Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
* Acute severe illness associated with weight loss in the last 6 months (defined as a loss of more than 5.0% total body weight)
* Active Cushings syndrome within the last 24 months
* Subject with overt diabetes mellitus
* Previous participation in this study
Evaluation of the Effects of Berry Leaf Extract on Cognitive Processing in Healthy Elderly Adults

This study aims to explore the positive effect of a dietary supplement composed of berry leaf extract on the cognitive performance and regulation of stress, mood, sleep and fatigue in healthy elderly adults with self-reported memory complaints

This study is designed as a randomized double-blind placebo-controlled interventional study. One hundred and six participants (aged between 60 and 80), with self-perceived memory complaints, will be randomly allocated to the control (placebo supplement) or test (active supplement) group. Participants will be supplemented during 12 weeks with those products. Cognitive performance and psychological and emotional processing will be measured with tests and questionnaires before (baseline), at the middle (6 weeks), and at the end (12 weeks) of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Healthy woman or man
* Aged of 60 to 80 years (inclusive)
* With self-perceived memory complaints (CDS score ≥ 15)
* With a Body Mass Index (BMI) comprised between 18 and 30 kg/m2 (included)
* Participants must have completed a minimum of 12 years of formal education, starting from the age of 6. This corresponds to an education level equivalent to the completion of secondary school (e.g., a high school diploma or equivalent)
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Stated willingness to maintain their usual life habits (diet, physical activity, alcohol consumption...)
* Speaking French

Exclusion Criteria:

* Subject with severe medical or cognitive problems which, in the opinion of the Principal Investigator, could interfere with the evaluation of the study criteria or with participant safety
* Subject with a MMSE score ≤ 24
* Subject with a coffee consumption of more than 5 cups per day
* Subject consuming drugs and/or with historical drug addiction (\<5 years)
* Subject with a regular alcohol consumption exceeding 3 standard drinks per day (10 g of pure alcohol each), equivalent to 3 glasses of wine (12 cl), 3 glasses of beer (5°, 25cl), or 3 glasses of spirits (18°, 7 cl)
* Smoker or subject consuming regularly products containing nicotine
* Subject following a vegetarian or vegan diet
* Subject with known hypersensitivity to any component of the study product
* Subject who has taken in the 28 days preceding the screening visit or is currently taking drugs or food supplements aiming at improving memory, concentration, sleep, stress, anxiety or other substances which could, in the opinion of the Principal Investigator, interfere with cognitive and emotional processing
* Subject participating in another intervention trial
Determination of Citrate Clearance Used in Regional Anticoagulation of Continuous Venous Hemofiltration Circuits

Citrate anticoagulation is becoming the gold standard in dialysis in intensive care units. It is now accepted that citrate prolongs the life of filters with a lower risk of bleeding.

However, the management of citrate is complex. Optimization is based on citrate flow, blood flow and the amount of calcium reinjected. Frequently the citrate level is sub-dosed.Currently, the fraction of excretion of citrate by the hemodialysis machine is unknown. Knowing this information would allow, if it is important enough, to add an additional parameter of citrate management by adapting the level of dialysis.

The determination of citrate in an extracorporeal circulation circuit has already been performed and has been validated in the literature. We propose to perform the assay on subjects with the same starting parameters, in order to deduce the clearance of citrate.


Eligibility Criteria:
Inclusion Criteria:

- Intensive care dialysis patients (Continuous Venous Hemofiltration with citrate).

Exclusion Criteria:

- None
Pilot Community Clinical Study of Hypothermia in Cardiac Arrest

The overall goal of this study is to determine the feasibility of initiating hypothermia in cardiac arrest patients as soon as possible in the field. In this pilot study we will randomize 125 patients after return of spontaneous circulation (ROSC) to hypothermia with rapid infusion of 2 liters of 4oC Normal Saline IV solution over 20 to 30 minutes, IV sedation and muscle paralysis or to standard of care following ROSC. The primary objectives of this study will be to determine whether temperature of 33-34oC can be achieved and maintained using this strategy. The primary outcome measures will include: temperature changes of the patients at time of admission to the hospital. Secondary analysis will include determining if the proportion of patients discharged from the hospital is increased in the group receiving hypothermia. If this initial pilot study can demonstrate feasibility in achieving and maintaining hypothermia, a larger randomized clinical trial to test the hypothesis that hypothermia initiation in the field will increase the proportion of patients surviving following cardiac arrest will be planned.


Eligibility Criteria:
Inclusion Criteria:

* Resuscitated out-of-hospital cardiac arrest defined as having a palpable pulse comatose IV access Intubated

Exclusion Criteria:

* age less than 18 traumatic cause of cardiac arrest
Has The COVID-19 Pandemic Affected Injury in Football?

This study aims to compare the injuries that occurred in the football players after the isolation and lack of training caused by New Coronavirus Disease (COVID-19), with the previous season, based on the example of a professional football team in Turkey.

This study aims to compare the injuries that occurred in the football players who faced an intense match tempo after the isolation and lack of training caused by COVID-19, as well as the stress and uncertainty, with the previous season, based on the example of a professional football team in Turkey. Injury follow-up data were examined.

Eligibility Criteria:
Inclusion Criteria:

* Having a musculoskeletal injury during the official match or team training in the 2019-2020 or 2020-2021 season

Exclusion Criteria:

* Signing a contract with Trabzonspor A Team in the 2020-2021 season
Sex-unique Disparities in Survival and Resuscitation After Out-of-hospital Cardiac Arrest - a Danish Analysis

The goal of this observational study is to investigate characteristics in out-of-hospital cardiac arrests (OHCA) related to sex differences.

The main questions it aims to answer are:

* are there possible differences in help provision by bystanders, cardiopulmonary resuscitation (CPR), pre-hospital treatment by emergency medical services (EMS)?
* are there differences in the presence of shockable initial rhythm (SIR) and survival rates after OHCA at successive stages of treatment? Researchers will compare all emergency medical services treated resuscitations in Denmark between 2016 and 2021 to see if there are possible differences between sexes.

This analysis will be based on data from the national electronic based Danish OHCA registry. Data on OHCAs with resuscitative attempts in Denmark have been collected in the electronic based Danish Medical Service report system since 2016. The registry covers detailed data including the EMS report, executive entries, and advanced text searches of prehospital charts. All cases go through an elaborate validation process where all identified events are read through manually by an external verification team. This ensures high quality of data, collected according to the Utstein recommendations, throughout the approximately 5400 cases of OHCA in Denmark annually. During this verification process, supplementary sources of data are linked to each OHCA, among others information about survival, localization, initiation of bystander CPR and EMS personnel operation.

Eligibility Criteria:
Inclusion Criteria:

- All emergency medical services treated resuscitations in Denmark between 2016 and 2021

Exclusion Criteria:

- Patients that are found dead at emergency medical service arrival, with sure death indicators such as rigor mortis or livores.
Cardiac Rehabilitation: Optimisation of the Functional Capacity of Patients Hospitalized With Cardiac Disease

The World Health Organization \[WHO\] (2021) states that Cardiovascular Diseases \[CVD\] are the leading cause of death in the world, and in 2019 around 17.9 million deaths were caused by CVD and the national picture is no different. In Portugal, demographic ageing continues to be established by the increase in average life expectancy, which in turn leads to an increase in the percentage of the population with CVDs. Of particular note is Ischemic Heart Disease \[IHD\], which is the second leading cause of death in Portugal In order to prevent and combat the progression of CVD and its complications, Cardiac Rehabilitation \[CR\] programs have emerged as a secondary prevention method supported by relevant scientific evidence. In this sense, the Portuguese Society of Cardiology recognizes the role of the Rehabilitation Nurse Specialist as a crucial element of CR teams.

Objective: To evaluate the effectiveness of the phase I cardiac rehabilitation program in patients hospitalized with ischemic heart disease, in terms of functional capacity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Myocardial Ischemia
* Patients who agree to take part in the rehabilitation exercise program
* Patients with the cognitive capacity to understand the instructions given, the exercises to be carried out and the teaching provided
* Patients with clinical and hemodynamic stability
* Patients participating in the rehabilitation exercise program for at least 2 sessions.

Exclusion Criteria:

* Patients who do not meet the safety criteria for exercising after a cardiac event
* Patients with osteoarticular pathology that compromises their ability to exercise.
Perinatal Outcomes in Umbilical Cord Entanglement

Umbilical Cord Entanglement and Perinatal Outcomes.

Umbilical Cord Entanglement and Perinatal Outcomes neonatal outcomes and the effect on mode of delivery

Eligibility Criteria:
Inclusion Criteria:

* all vaginal deliveries with or without Umbilical Cord Entanglement

Exclusion Criteria:

* multible pregnancy