cyrilzakka/clinical-trials huggingface dataset:
Identifying Biological Markers of Cardiovascular Events in Patients With Aortic Stenosis or TAVI

Aortic stenosis, a common cardiovascular disease, is pathophysiologically associated with a chronic inflammatory myocardial reaction and fibrosis leading to cardiac dysfunction and impaired coronary perfusion. These elements may precede the onset of symptoms. The assessment of inflammatory and fibrosis factors (in particular by means of biomarkers) in patients with aortic stenosis will make it possible to identify asymptomatic patients at greater risk who could benefit from intervention earlier. This is part of a personalised medicine adapted to the patient.

Patients will be recruited during their TAVI (Transcatheter Aortic Valve Implantation) assessment consultation. If the patient agrees to take part in the study, information relating to routine care procedures will be collected (patient history, clinical examinations, electrocardiogram, echography, coronary angiography, TAVI procedure if applicable, biology).

Outside of routine care, a biocollection will be established (serum, plasma), quality of life questionnaires will be carried out and adverse events will be collected where present.

Patients will be divided into 3 groups according to the indication for TAVI (Group A - symptomatic severe aortic stenosis with indication for TAVI, Group B - asymptomatic severe aortic stenosis without indication for TAVI, Group C - asymptomatic moderate aortic stenosis without indication for TAVI).

The main objective is to compare the levels of biomarkers of inflammation and fibrosis between the 3 groups at each sampling time common to all three groups between inclusion and 1-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>=18 years of age
* Patient with symptomatic or asymptomatic severe or moderately severe aortic stenosis (according to the recommendations of the European Society of Cardiology - ESC).
* No opposition.

Exclusion Criteria:

* Conjunctive heart disease (e.g. amyloidosis).
* Presence of a contraindication to TAVI.
* Impossibility of giving the subject informed information.
* Privation of civil rights (curatorship, tutorship, protection of justice).
Randomized Controlled Trial of Acupuncture for Dysmenorrhea

Since there is unsatisfactory effect by currently pharmacologic therapies and preventive strategies for dysmenorrhea, this study is designed to evaluate the efficacy and quality of life of acupuncture for patients with dysmenorrhea based on the theory of traditional Chinese Medicine.

There were abundant clinical experiences and medical records for dysmenorrhea in traditional Chinese medicine. So we follow the worldly trend to do the research of integrative Chinese medicine and western medicine since WHO launched the first global strategy on traditional and complementary/alternative medicine (TM/CAM) to assist countries to create a stronger evidence base on the safety, efficacy and quality of the TM/CAM products and practices.

The purpose of our study is to create the evidence of effect on dysmenorrhea by acupuncture. The study will be performed under randomized, open, controlled design. The effect of acupuncture and control group will be compared including the following outcomes: pain score (Visual Analogue Scale), quality of life (SF-36, Taiwan version), overall improvement in dysmenorrhea, adverse effects from treatment, requirements for additional medication, restriction of daily life activities, absence from work or school.

Eligibility Criteria:
Inclusion Criteria:

* non-pregnant women who are at least 13 years old
* the one who meet any one of the following two criteria: 1.suffering from dysmenorrhea in recent 3 menstrual periods; 2.dysmenorrhea with poor response to non-steroid anti-inflammation drugs

Exclusion Criteria:

* intrauterine device-related dysmenorrhea
* history of alcohol or drug abuser
* women who are pregnant, as determined by a urine pregnancy test
* history of adverse reaction to acupuncture
* received herb or acupuncture therapy within one month prior to enrollment
* poor compliance to investigator's advice
Pressure Wire Guided Cardiac Resynchronisation Therapy

Heart failure patients may benefit from having a special pacemaker implanted that can make the heart pump in a more coordinated and efficient way Cardiac Resynchronisation Therapy (CRT). For the heart to pump well it is necessary for the pacing wires to be placed in optimal positions. Only two thirds of people respond to CRT and this may be because of non-ideal pacing wire position. A potential marker for response is the change in heart pump pressure change over time. The aim of this study is to use a specialised wire in the main pumping chamber of the heart to record the pressure changes with the pacing lead in various positions to determine the optimal position. It is postulated that the improved pressure changes will increase the proportion of responders.

Pilot study work has shown that the work is technically feasible and safe. The initial data has been published in a highly regarded scientific journal. This main study will be a multicentre randomised controlled trial whereby patients will be randomised to either standard treatment or pressure wireguided treatment. The patients in the pressurewire guided arm will have a specialised wire implanted into the main pumping chamber of their heart via a blood vessel at the top of the leg (or less commonly a blood vessel in the wrist). This will measure acute pressure changes over time and the pacing lead will be positioned in the site that gives the greatest change in pressure.

If the patients in the pressurewire guided arm fare better than those receiving standard treatment it may alter how a large proportion of heart failure patients are treated around the world. The study requires 282 patients and is likely to take two years to complete.


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling standard criteria for CRT
* Ischaemic or non-ischaemic heart failure

Exclusion Criteria:

* Contraindication to pressure wire assessment including:
* Severe aortic valve disease
* Mechanical aortic valve replacement
* Severe peripheral vascular disease
* LV thrombus
The Effect of Music and Environmental Noise Isolation on Bronchiolitis Severity in Hospitalized Children: a Randomized Control Trial

Bronchiolitis is an infectious disease, with no effective treatment. Music and Mozart's works specifically, has been shown to have a positive effect on physiological parameters, while environmental noise is considered to be harmful. We aimed to evaluate the short-time effect of listening to music and detachment from environmental noise on the severity of bronchiolitis in hospitalized children.

MP3 player devices were uploaded with 3 different pieces: 1) sonata for 2 pianos in D major, K.488 by Mozart (2) instrumental music ("To the Point", by Dean Evenson \& Tom Barabas) and (3) silence. All music or silence pieces were identical in length (24 minutes in accordance to the duration of the sonata).

Music fragments were played using headphones suitable and approved for use in children - GSI (Grason-Standler) Insert Earphone TIP-50 (50 ohm) (Grason Standler Inc. Madison, WI, USA). Sound frequency and volume were adjusted to the age appropriate values33 Children were randomly divided into 3 groups according to the type of intervention. Randomization, numbering of the MP3 players and coding of the content were done by a research coordinator not involved in evaluation of the patients nor in analysis of the results.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 0-24 months, with the clinical diagnosis of bronchiolitis.

Exclusion Criteria:

* Children who failed neonatal hearing screening or in whom the results of the screening were not available were excluded from the study.
* Children who were not able to maintain listening for at least 10 minutes were excluded from data analysis
Does the Disinfection of the Subcutaneous Tissue Reduce the Contamination of the Operative Field by P. Acnes During Primary Shoulder Surgery?

Propionibacterium acnes is a pathogen frequently identified during postoperative infections of the shoulder. A recent study has shown that P. acnes is likely to be disseminated in the operative field from the subcutaneous layer by soft tissue manipulation by the surgeon and the instruments (Falconer 2016). This study seeks to evaluate the effectiveness of subcutaneous tissue disinfection on P. acnes contamination during primary shoulder surgery. The literature shows that approximately one-third of patients have a P. acnes-infected surgical drape during primary shoulder arthroplasty (Falconer 2016). The source of this contamination would be the subcutaneous tissue. The hypothesis is that a disinfection of the subcutaneous tissue would reduce the contamination of the operative field with the aim of reducing the infection rate after shoulder surgery.

It is a randomized, single-center, open-label, category A clinical trial, a research project on people involved in the collection of biological material and the collection of health-related personal data with the existence of consent.

The investigators will study the effectiveness of Betadine subcutaneous tissue disinfection during primary shoulder surgery. They will randomize 105 patient on two arms. The control group receiving no disinfection of the subcutaneous tissue (A) and intervention group, receiving disinfection of the subcutaneous tissue (B). The investigators estimate that 4 years is enough to recruit the number of patients needed for this study.

All patients 18 years of age or older admitted to the Valais Hospital to receive primary shoulder surgery and who have signed the consent of the study will be eligible.

Eligibility Criteria:
Inclusion Criteria:

1. = or\> 18 years
2. Supported at the Valais Hospital for primary surgery of the shoulder.
3. Have signed the consent

Exclusion Criteria:

1. \<18 years old
2. History of shoulder surgery
3. History of infection of the shoulder
4. Antibiotherapy in the 2 weeks preceding the intervention
5. Infiltration of cortisone in the 6 months preceding the intervention
6. Iodinated contrast medium allergy or cefuroxime
7. Allergy to the povidone iodine complex or other contraindication to Betadine namely:

   Hypersensitivity to the active ingredient, iodine or povidone iodine complex, or to any of the excipients according to the composition.

   Hyperthyroidism and other overt thyroid diseases. Dermatitis herpetiformis of Duhring. Before and after radioactive iodine treatment (until the end of treatment)
8. Refusal of the terms of the study
Effects of Moderate Physical Activity on Glycemic Control in Type 2 Diabetes Mellitus

The study design is to determine the effectiveness of moderate physical activity on g;lycemic control in type 2 diabetes mellitus.

To the best of authors knowledge so far the studies have been conducted on different modes of moderate physical activity on glycemic control in type 2 diabetes, current study goal is to evaluate which mode of moderate physical activity has more significant result on glycemic control in type 2 diabetes and is sustainable in Pakistani society according to the socioeconomic status and cost effectiveness of the modes of moderate physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Participants falling in this category would be recruited into the study.
* Male/female
* Diabetic type 2 patients
* Age: 30-70 years
* BMI \>25
* Overweight
* Fat % in male\> 25
* Fat % in female \>35
* HbA1c level more than 48mmol/mol or \>6.5%
* Fasting Plasma Glucose level \>126 mg/dl (7.0 mmol/l)
* Random Plasma glucose level \>200 mg/dl (11.1 mmol/l)
* Physically active ( have no mobility problems)

Exclusion Criteria:

* Participant failing to fall in this category would be excluded of the study.
* Type 1 diabetes
* Insulin dependant type 2 diabetes
* Gestational Diabetes
* Hypertension
* Cigarette smoking
* Cardiovascular Disease
* Cerebrovascular disease
* Cardiopulmonary Disorders
* Cognition Problems
* Peripheral Artery Disease
* Dyslipidemia
* Proliferative or preproliferative retinopathy
* Nephropathy
* Neuropathy
Dermacyd PH_DETINBACK (Lactic Acid) Sweet Flower - Photo Avaluation

The purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product Dermacyd PHDETINBACK Sweet Flower.


Eligibility Criteria:
Inclusion criteria:

* Phototype Skin II and III;
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection;
* Diseases which can cause immunity decrease, such as HIV, diabetes;
* Use of drug photosensitizer;
* History of sensitivity or irritation for topic products;
* Active cutaneous disease which can change the study results;
* History of photodermatosis active;
* Family or personal antecedent of cutaneous photoinduced neoplasias;
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium;
* Intense solar exposure in the study area;
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Decision-making for Food Consumption in Young Adults

Background: Experimental and cross-sectional evidence suggests that poor executive function can lead to heightened reactivity to food cues and perceived greater reward of unhealthy but palatable foods and subsequently lead to overeating or clinical eating disorders. This may be an important reason for the increasing trend of obesity in our society.

Aims: This study will investigate the interrelationships among executive function, reactivity to food-related cues and eating style in young adults. In addition, this study will examine the influence of food environment and stress on reactivity to food-related cues and executive function and how executive function and reactivity to food-related cues would influence health risky behaviours in young adults. We will also conduct a pilot randomized control trial (RCT) to develop the culturally specific goal priming intervention for the Chinese adults and test its effect on decision-making for food choice among adults with low executive function.

Design and subjects: This will be a three-wave cohort study in young adults who are recruited in their final-year of first post-secondary education and follow-up at six months and 12 months after their graduation. For the pilot RCT, a 2 (low vs. high executive function) x 2 (with vs. without goal priming intervention) will be used to test the effect of goal priming intervention on food choice. The goal priming intervention will be 5-min word-searching task to prime goals of healthy eating.

Main outcome measures: Participants will be invited to complete a series on computerized tasks and other assessments online in each wave to assess their executive function, risk taking propensity, reactivity to food-related cues, perceived stress, exposure to food-related cues, eating style and other health-related behaviours. Structural equation modelling will be used to test the interrelationships among executive function, reactivity to food-related cues and eating style, among exposure to food-related cues, perceived stress and reactivity to food-related cues, and among executive function, reactivity to food-related cues, risk taking and adoption of health-related behaviours. For the pilot RCT, the effect of intervention on tendency of choosing healthy and low-calorie foods will be evaluated using logistic regression model with level of executive function and goal-priming intervention as the main between-group factors.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults who can speak Chinese or Mandarin
* Aged between 18 and 30 years

Exclusion Criteria:

* Having cognitive difficulties to understand the study instruments
* Having a physical or medical condition that requires certain food or dietary restrictions
* Having been diagnosed with any pathogenic eating disorders
* Participants whose subject is related to psychology
Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis.

The aim of this study is to evaluate the incidence of short-term urinary retention and the cure rate in patients with stress urinary incontinence undergoing surgical treatment with fascial pubovaginal sling with two tension adjustment techniques: the classic adjustment technique ("2 fingers") and measuring the distance between the fixation knot and the aponeurosis of 4 cm.

A randomized double-blind clinical trial will be conducted in women over 18 years of age with stress urinary incontinence and indication for surgical treatment, who have not undergone previous surgical treatment. Postoperative follow-up will be 1 month when the incidence of urinary retention and the rate of cure after the procedure will be evaluated. The incidence of urinary retention in 1 month postoperatively will be evaluated in the two different techniques (post-voiding residue \> 200ml or the need for intermittent bladder catheterization) and the cure rate for urinary incontinence (cough test and response "No" to the question 3 of the Urogenital Distress Inventory questionnaire).

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and no improvement with conservative management

Exclusion Criteria:

* Prior anti incontinence surgery
A Randomized Control Trial Testing Connective Tissue Grafts vs. Allograft on Dental Implants

This randomized controlled clinical pilot trial compared the efficacy of two soft tissue grafting methods for correcting esthetic discrepancies associated with non-molar implants in the maxilla. Specifically, it was explored whether defects treated with connective tissue grafts (SCTG) differed in their outcomes from defects treated with acellular dermal matrix allografts (ADM).

Thirteen patients who presented with implants displaying recession, thin biotype, concavity defects or a combination thereof associated with single crowned dental implants participated in this randomized control trial. The control group (N=7) received SCTG and the test group (N=6) received ADM, both under coronally positioned flaps. Data were collected before surgery, and 6 weeks, 3 months, and 6 months after the surgery. Outcome measures included soft tissue, hard tissue, and esthetics parameters and psychosocial data.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults of at least 18 years of age
* Maxillary non-molar implant with failing pink esthetic profile
* Implants with adjacent landmarks (only one can be an implant)
* Healthy implants measured by the lack of peri-implantitis and mucositis
* Good oral hygiene.

Exclusion Criteria:

* Unstable systemic diseases, compromised immune system, or unstable bleeding disorders
* History of radiation or cancer in the oral cavity
* Use of IV bisphosphonate or steroid medication
* Use of tobacco products (\>1/2 pack per day)
* Pregnancy
* Mucogingival surgery or implant placement within the past six months
An Intracavitary Electrocardiographic System for Real-time Positioning Peripherally Inserted Central Catheter Tip

The purpose of this study is to compare a new intracavitary ECG guiding method for real-time positioning the tip of three-way valve type peripherally inserted central catheters versus conventional surface prediction length method in terms of single-time target rate.

The use of peripherally inserted central catheters (PICCs) has increased significantly for cancer patients receiving chemotherapy. For these patients, PICCs afford many advantages with regards to complications and treatment convenience.

Current practice utilizes the estimated length of the catheter from puncture site to the junction of superior vena cava / right atrium (SVC-RA) for guiding tip placement. Next the catheter tip placement was confirmed by radiographic imaging prior to use of the line for administration of chemotherapy medications. In this case, the catheter is often mal-positioned and requires adjustment and repeat radiographic imaging in order to ensure proper placement, ideally at the SVC-RA junction. These potentially additional procedures are time-consuming and also expose patients, nurses and physicians to radiations.

Intracavitary electrocardiogram with an electrode placed inside the catheter during insertion has shown identifiable changes in P-wave, which are sufficient to guide PICC tip placement. Moreover, less procedural time and radiation are expected.

This study aims to demonstrate if this intracavitary electrocardiogram guided method is superior to conventional surface prediction length method in terms of single-time target rate of correct tip placement. In addition, we would like to investigate symptomatic thrombosis incidence and its risk factors after three-valve PICC implanted among patients with malignant tumors; to clarify procedure time used and cost of the new intracavitary ECG guiding method and to explore the maximal P-wave amplitude of intracavity ECG real-time positioning technology and its predictive factors.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with malignant tumors who will require periodical infusion of chemotherapy drugs using three-valve PICC;
2. Aged \>18 to \< 80 years old;
3. Baseline ECG records prior to PICC catheter showed normal P wave;
4. Agreed to participate in this study, and signed PICC informed consent.

   Exclusion Criteria:
5. Patients with heart diseases, such as valvular heart disease, atrial fibrillation, supraventricular tachycardia, pulmonary heart disease or having a pacemaker and post cardiac surgery which may affect P waves.
6. Patients unable to lie in the prostrate or semi-supine position.
mCVI Confirmatory Clinical Study: Algorithm Verification

This single center confirmatory clinical study is to verify the algorithm of mCVI® to accurately capture pulse rate and respiratory rate in 20 healthy subjects in comparison to commercially-available Masimo pulse oximeter devices. This is a non significant risk device.

In this confirmatory clinical study the mCVI® device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing. There is no facial recognition technology. There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions. In real time, the mCVI® device will be compared to two commercially available Masimo pulse oximeter devices in a single visit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults between the ages of 21 - 70

Exclusion Criteria:

* Medical conditions that could compromise a participant's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
* Medications that could compromise a participant's ability to participate in the study
* Documented medical history of respiratory or cardiovascular disease
* Excessive facial hair, facial deformities, or obstructions (like glasses or face masks/shields) that could compromise the recording of pulse rate and respiratory rate of the mCVI®
* Any face lotions or make up foundations that could compromise the recording of pulse rate and respiration rate of the mCVI®
* Missing digits or fingers on one or more hand that would prevent proper recording of Masimo pulse oximeter devices
* Participants wearing nail polish, acrylic nails, or rings on the ring finger of either hand that would prevent the proper use of Masimo pulse oximeter device
* Recent (≤ 1 month) surgical procedure of any kind
* Current participation in another investigational clinical trial
* Inability to provide informed consent