cyrilzakka/clinical-trials huggingface dataset:
Breast Cancer Screening Uptake: a Randomized Controlled Trial Assessing the Effect of a Decisional Aid

Shared decision-making for organised breast cancer screening (OBCS) could be improved by fostering interaction and exchanges of information between women and General Practitioners (GPs), for instance by including an assistance tool in the dispatch of the invitation letter for Organised Screening for breast cancer. In 2018 the national cancer Institute funded the development of a decisional aid (DA) on the theme of whether or not to take part in breast cancer screening, specific to the French setting. It is the website Discutons-mammo.fr DEDICACES project 1.

DEDICACES 2 is a population-based trial with a cluster design. It studies humans, without modifying their usual care. The experiment assesses the effect of the discutons-mammo.fr tool on the decision to take part (or not) in OBCS among women who are invited for screening.


Eligibility Criteria:
Inclusion Criteria :

- General practitioners (GPs):

The following GPs will be included:

1) Practicing in one of the French départements (administrative area) covered by the study.

- Women:

The following women will be included:

1. Invited to participate in OBCS by the National Health Insurance Agency (Caisse Nationale d'Assurance Maladie; CNAM) during the studied month: eligible for OBCS, therefore aged between 50 and 74 at the time of inclusion;
2. On the patient list of a GP who is covered by the study at the time of inclusion;
3. Covered by one of the CPAM (Caisse Primaire d'Assurance Maladie) in the participating departments.

Exclusion Criteria :

- General practitioners (GPs) :

The following GPs will be excluded:

1. Those who do not have any patients invited for OBCS in the studied month;
2. Those whose practice does not correspond to the usual activities of a GP (known as a Mode d'Exercice Particulier), or who have very few patients (who have seen fewer than 100 different patients in the year preceding the experiment);
3. Those who practice within a health centre (as it is impossible to evaluate the activity of an individual practitioner in health insurance databases);
4. Those who explicitly state that they do not want to take part in the study, in response to an initial letter of invitation. This letter will inform them that the study is being run, and will inform them of the option to refuse to participate if they so wish;
5. Those who are participating in the MyPEBS study (the only national study of OBCS at the time the present protocol was drawn up).

   * Women:

The following women will not be included:

1. Participants in the MyPEBS study ( the only national study of OBCS at the time the present protocol was drawn up); or,
2. If their GP refuses to participate in the study; or,
3. women under guardianship.

The following women will be excluded:

* Those who object to the study in accordance with regulatory procedures issued by the Data Protection Officer (DPO),
* Those who do not respond within 1 month after the questionnaire has been sent.
Single and Multiple Dose Pharmacokinetics of BMS-986165 in a Randomized, Double-Blind, Placebo-Controlled Study in Healthy Chinese Subjects

Main objective of this study is to assess BMS-986165 plasma PK following single and multiple oral doses of BMS-986165 in healthy Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent.
* Healthy participants, as determined by physical examination, ECGs, and clinical laboratory and procedure determinations.
* Body mass index (BMI) of 18 to 24 kg/m2, inclusive, and total body weight \>= 50 kg.

Exclusion Criteria:

* History of allergy to drug class or related compounds.
* History or evidence of active infection within 7 days of study day 1.
* Drug or alcohol abuse within 6 months of study treatment administration.

Other protocol defined inclusion/exclusion criteria could apply
CYP4A11 and CYP4F2 Gene Variants as Makers of Cardiovascular Adverse Events of Non-steroidal Anti-inflammatory Drugs

Randomized, double-blinded, cross-over and placebo controlled clinical trial to evaluate the association between genetic polymorphism of CYP4F2 with cardiovascular adverse effects of non-steroidal anti-inflammatory drugs (NSAIDs). Two groups were included according the CYP4F2 V433M genetic polymorphism (control - MM, N=7 vs. VV or VM variants, N=13). According the sample size planned, a mean difference of total body water delta between groups (control vs. polymorphic) of at least allow 10% could be observed.


Eligibility Criteria:
Inclusion Criteria: Healthy volunteers 18-65 years-old -

Exclusion Criteria: Use of drugs and without clinical history of adverse effects of NSAIDS

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Safety of Non-delayed Weight Bearing After Total Hip Replacement With Non-Cemented Fiber Metal Taper Stem

The purpose of this study is to determine if full weight bearing following total hip replacement can speed recovery when the hip replacement in the long bone of the leg is not cemented into the bone. When cement is used, most surgeons allow full or nearly full weight bearing following hip replacement. One drawback to cementless implants has been the restriction of weight bearing for six to eight weeks after surgery, during which time patients are allowed to only put their foot flat on the floor of the operated leg without bearing weight on that leg. This study compares the effect of immediate weight bearing on the speed of recovery from hip replacement surgery in two groups of patients receiving a non-cemented total hip replacement: one group is randomly assigned to not bear weight, and the other group is randomly assigned to allowed, tolerated weight bearing from the day of surgery forward.

Patients undergoing non-cemented total hip arthroplasty with a Zimmer Fiber Metal Taper Stem and who meet the inclusion and exclusion criteria are offered the informed consent process. Those consenting are randomized following surgery by flip of a coin into one of two groups: Weight Bearing as Tolerated or Toe Touch Weight Bearing Only. Each patient is followed for two years, and is seen at 6 weeks, 3 months, 1 year and two years. Questionnaires are completed including the Harris Hip Score and the SF-36. Patients complete a compliance survey to determine behavior related to their study group assignment and compliance with their study group. Radiographs are obtained at each post-operative interval and subsidence is evaluated and recorded. Range of motion and ambulation are assessed and recorded also.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* English Speaking
* any form of hip arthritis
* primary total hip arthroplasty
* willing to sign informed consent

Exclusion Criteria:

* under age 18
* non-English speaking
* critically ill patients
* people who are unable to follow-up appropriately due to travel concerns or mental illness.
* revision total hip arthroplasty
* trochanteric osteotomy
* intra-operative fracture
* prisoners
* not willing to sign informed consent
Preoxygenation Before Prehospital Tracheal Intubation With NIV Versus Balloon

Recent studies reports feasibility, effectiveness and even less complications of using NIV for preoxygenation during tracheal intubation in ICU and in Operating Room. None study has been done in emergency out-of-hospital medical rescue. This trial attempts to demonstrate same results or even more in that conditions.

This trial will compare classical preoxygenation strategy with unidirectional valve autofilling balloon versus NIV.

Eligibility Criteria:
Inclusion Criteria:

* Patients needing chest tube intubation

Exclusion Criteria:

* Cardiac arrest
* Children
* Pregnancy
* Incompetents
Meridian Activation Remedy System for Parkinson's Disease

In this study, the investigators aim to evaluate the clinical efficacy and cost-effectiveness of MARS-PD. Conventional, usual care will be used as the comparator because this trial aims to assess the add-on effect of MARS-PD. The investigators hypothesize that the complex therapy will relieve motor and nonmotor symptoms, improve gait performance, and enhance neuroplasticity in PD patients, and will be safe and cost-effective.

This study is a randomized controlled trial conducted at a single center with raters blinded to the intervention. We will look at the clinical effect of MARS-PD, consisting of 16 interventions over an 8-week period, in 88 individuals with Parkinson's disease. Patients will be assigned to either the experimental (n=44) or control (n=44) groups at random. he experimental group will receive the MARS intervention, while the control group will receive usual care only. The treatment duration is 8 weeks, followed by a 12-week follow-up. The primary outcome is the change in MDS-UPDRS Part III (Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III) score from baseline to 8 weeks. Secondary outcomes include assessments such as MDS-UPDRS, International Physical Activity Questionnaire Short Form, Parkinson Self Questionnaire, Parkinson's Disease Sleep Scale, Timed Up and Go test, GAITRite metrics, Functional Near-Infrared Spectroscopy measurements, smart band results, gut microbiome composition and diversity, and iris connective tissue texture.

Eligibility Criteria:
Inclusion Criteria:

1. 45 to 75 years of age
2. Patients with PD, diagnosed according to the United Kingdom Parkinson's Diseases Society Brain Bank Criteria
3. Hoehn and Yahr scale stage I to III
4. Patients who have voluntarily decided to participate in the clinical study and signed the informed consent form

Exclusion Criteria:

1. Clinically unstable patients (e.g., elevated aspartate transaminase (AST) or alanine aminotransferase (ALT) more than three-fold the upper limit of normal in the research institute's laboratory, heart failure, respiratory failure, etc.)
2. Patients who are planning to undergo deep brain stimulation within the study period
3. Pregnant or lactating women
4. Patients with MMSE-K (Mini-Mental State Exam) score of 18 or less
5. If there has been a change in the dosage of antiparkinsonian drugs (e.g., L-dopa, COMT (catechol-O-methyltransferase) inhibitor, Dopamine agonist, MAO-B (monoamine oxidase B) inhibitor, etc.) according to a doctor's prescription within the last 4 weeks prior to enrollment
6. Patients who are receiving manual therapy, exercise therapy, or rehabilitation therapy for Parkinson's disease according to a doctor's prescription within the last 4 weeks prior to enrollment, or are planning to receive such therapy within the study period
7. Patients who are not suitable for participation in this clinical study according to the judgment of the researcher
Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM)

Clinical alopecia occurs due to miniaturization of the hair shafts as well as loss of active production of hair shafts. PRFM has been shown to induce dermal angiogenesis, and anecdotal findings of improvement of hair appearance after PRFM injection in the scalp suggest that PRFM may play a role in the treatment of thinning hair. Patients will be treated on a monthly basis with intradermal injections of autologous PRFM for 3 months. Changes in hair density will be assessed by comparing pre- and post-treatment photographs and non-invasive measurements of hair density at 1, 2, 3, 4 and 6 months after initial treatment.


Eligibility Criteria:
Inclusion Criteria:

* age 18- 75 years old
* frontal and/or crown alopecia

Exclusion Criteria:

* bleeding disorder
Acute Cardiovascular and Metabolic Effects of Exercise Training in Individuals With Insulin Resistance

The overall aim of the project is to determine whether or not exercise influences cardiovascular or nervous responses to meal ingestion in individuals with insulin resistance or type 2 diabetes.

Participants will undergo a screening procedure, including telephone screening and physical examination, as well as determination of body composition and fitness. Participants will be asked to complete 5-10 days of supervised exercise training and will undergo testing to assess cardiovascular and metabolic responses to an oral glucose tolerance test, including muscle sympathetic nerve activity, blood flow, and circulating glucose and insulin concentrations at baseline and following training. In addition, day-to-day variations in blood glucose will also be monitored. The overall aim of the project is to determine whether or not acute exercise training influences postprandial metabolic, vascular or autonomic nervous system responses in individuals with insulin resistance or T2D.

Eligibility Criteria:
Inclusion Criteria:

* Insulin resistant: diagnosed with pre-diabetes or fasting blood glucose \>/= 100 mg/dL
* T2D: diagnosed by primary care physician
* BMI: less than 43 kg/m2
* Age: 30-65

Exclusion Criteria:

* Smoking
* Insulin use (other than once daily)
* Underlying conditions that limit ability to exercise safely
* Recent weight gain or loss (\>5% of body weight in 3 months)
* Physically active (\>30 min aerobic exercise, 2 d/wk)
* Recent (\<3 mo) changes in medication use or dose
* Uncontrolled T2D (HbA1c\>10%)
* Advanced retinopathy or neuropathy
* Pregnancy
Non-Interventional Post Marketing Surveillance Study of Neovasculgen® in Patients With Chronic Lower Limb Ischemia

Aim of the study is to gain more knowledge about efficacy and safety of Neovasculgen® in daily clinical practice and obtain information about the quality of life in patients treated with Neovasculgen®.

This is an open, controlled, prospective, comparative, multicentre study design. All patients received standard conservative therapy for chronic limb ischemia without cilostazol and prostaglandins and without surgical or endovascular vessel reconstruction. Surgical and endovascular vessel reconstruction was unsuitable for all of the patients

Eligibility Criteria:
Inclusion Criteria:

* Male or female person aged 40 or older
* Subject with diagnosed lower limb ischemia (Fontaine-Pokrovsky Stages IIa-III of chronic limb ischemia)
* Signed informed consent

Exclusion Criteria:

* Any disease that can, in the opinion of the treating physician, affect the outcome of the study
* Patients with addictive disorders or substance abuse
* Pregnancy or nursing
* All other exclusion criteria listed in the summary of product characteristics (SmPC)
Gastric Residual Volumes in Infants Fed at 4 and 6 Hours Prior to General Anaesthesia

The safety implications of prolonged fasting in young children prior to general anaesthesia are well described. Current UK guidance recommends a fasting time of 6 hours for formula milk prior to general anaesthesia. European guidance published in 2022 recommended a reduced fast of 4 hours for infants taking formula milk, albeit with a downgraded level 2B of evidence given the paucity of high quality research in this area. Although pulmonary aspiration of gastric contents under anaesthesia in children is a rare event, animal studies suggest that aspiration of particulate matter at volumes greater than 0.8 ml/kg gastric volume are associated with demonstrable lung injury and mortality. Although rate of gastric emptying of formula preparations has been extensively studied in neonatal intensive care settings for preterm babies using ultrasound, few studies have measured gastric volume directly in healthy term infants undergoing anaesthesia.

Traditional fasting guidelines of 6 hours for formula milk may be unnecessarily long. In practice, children also tend to be fasted for longer than the guidelines advise, as they may not always feed on cue, and delays in the hospital can occur on the day of surgery. Prolonged fasting in young children and infants is less well tolerated than in adults and can lead to hunger, dehydration and low blood sugar, as well as distress for the child and parents. We know from previous research in smaller babies that after a formula feed, the stomach empties by half in around 80 minutes, and empties completely by around 3 hours.

The investigators want to find out if young children and infants who are fed with formula milk 4 hours prior to an anaesthetic have similar levels of stomach contents at the time of their anaesthetic as those who are fed at 6 hours.

The investigators will carry out a clinical trial where children are randomised into 2 groups. Parents of children in Group 1 will be asked to offer a formula feed to their child 6 hours prior to the planned start time of their anaesthetic. Parents of children in Group 2 will be asked to offer a formula feed to their child 4 hours prior to the planned start time of their anaesthetic. Prior to having their anaesthetic a study team member will perform an abdominal ultrasound scan to check and record antral cross sectional area. Once asleep, gastric aspiration will be performed via naso-gastric tube. Volume, colour and pH of the fluid will be measure

The volume and acidity of any stomach contents will be compared between group 1 and group 2.

Eligibility Criteria:
Inclusion Criteria:

Term or term corrected (\> 37 weeks) upto 12 months Formula fed ASA 1-3

Exclusion Criteria:

Significant reflux Co-administration of drugs known to impact gastric motility or PH of gastric contents Significant respiratory comorbidity including chronic lung disease on home oxygen Significant cardiac comorbidity
Driving Pressure as a Predictor of Mechanical Ventilation Weaning Time on Post-ARDS Patients in Pressure Support Ventilation.

With the birth of Mechanical Ventilation in the 1950s came the ventilation induced lung injuries (VILI). Numerous works have since then shown the benefit of "protective ventilation", notably by controlling the delivered tidal volume and pressures. However, as the respiratory condition improves and the weaning is started by shifting to Pressure Support Ventilation (PSV), these parameters stop being tightly controlled. This study aims to determine whether there is a relationship between the driving pressure measured in PSV and the weaning time.

Scientific justification :

As mechanical ventilation developed since the 1950s, researchers started to recognize characteristic lung disease associated with it, Nash et al giving an anatomopathological description of "Respiratory Lung" on post-mortem examination of lungs after mechanical ventilation in 1967 \[2\]. It progressively led to the concept of VILI and of the protective ventilation to minimize it, enhancing lower tidal volume and plateau pressure \[3\], controlled Driving Pressure \< 15cmH2O\[4\], neuromuscular blockade\[5\] and prone positioning\[6\]. However, these parameters can only be controlled for sedated patients in Controlled Ventilation. As the respiratory conditions improve, the onset of spontaneous breathing uses PSV \[7\] but because pressure support is added to the inspiratory effort of the patient, tidal volume and driving pressure stop being tightly controlled. It is therefore possible for the driving pressure to be higher than 15 cmH2O in case of a major inspiratory effort. One ought to wonder whether a high driving pressure is associated with a prolonged weaning phase following a moderate to severe ARDS.

Strategy description:

Patients that enter the weaning phase following a moderate to severe ARDS equipped with a nasogastric allowing measures of EAdi will be included. Driving Pressure will be measured following the method used by Bellani et al \[1\]. A weaning test will be conducted daily.

Follow up description:

* Daily measures of End Inspiratory Pressure with respiratory synchronisation optimised by use of EAdi
* Daily spontaneous breathing trial using low levels of pressure support
* Pplat, Respiratory System Compliance, Driving Pressure, PEEP, Tidal Volume will be monitored daily as well as clinical and other routine ventilatory data. Data concerning initial severity of ARDS, and duration of ARDS, controlled mechanical ventilation, sedation and neuromuscular blockade and date of first spontaneous breathing trial will be collected. A weaning test will be conducted daily.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patients hospitalized in the ICU and who have suffered moderate to severe ARDS (Berlin criteria) equiped with nasogastric feeding tube allowing measures of Eadi

Exclusion Criteria:

* COPD or measured or suspected auto-PEEP higher than 3 cmH2O at beginning of Pressure Support
* Admission in the ICU more than 15 days before the initiation of weaning
* Broncho-pleural leaks
* ECMO
* Pregnant woman.
NUtrition and ORal Health in Orthopaedic Surgery

This prospective observational study evaluates the relationship between the objective oral health status and the patient reported diet in 64 adult patients undergoing elective major orthopaedic surgery (hip, knee, or spine surgery).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥55
* Male and female gender
* Major elective orthopedic surgery (hip, knee, spinal)
* Signature of the informed consent

Exclusion Criteria:

* Inability to follow the study protocol
* Neuropsychiatric disease, developmental disorders
Trial of Two Electric Breast Pumps in Mothers of Term Infants.

This is a randomised trial of two modern single electric breast pumps allocated to mothers who are exclusively breast feeding their healthy term infants. Mothers will be recruited when their infants are around a month old, they will be randomised either to use one of two state of the art modern single electric breast pumps or to act as controls with no breast pump (but will receive a baby care voucher of similar value). If allocated to a breast pump, mothers will be asked to take part in a physiological study when their babies are 6 weeks old. In this test the mothers will be asked to express breast milk for 10 minutes on each breast. The primary hypothesis is that the total weight of milk produced in a 20 minute period and the weight of milk produced at 1 minute intervals at age 6 weeks will be greater for mothers using one of the pumps. A small sample of breast milk (\~5ml) will be collected for analysis, the remaining expressed milk will returned to the mother.

Each month between the age of 3 and 6 months, all the mothers will be asked to complete online questionnaires about their breast-feeding and the use of their breast pumps (if they have one). At the end of the six months the mothers will be given a small voucher for a child-care store as a way of saying 'thank-you' for the inconvenience caused.


Eligibility Criteria:
Inclusion Criteria:

Mothers who have delivered healthy, term, singleton infants with no contra-indications for successful breast feeding.

Mothers who are exclusively breast feeding and are willing to be randomised to either use a breast pump or to continue breastfeeding without using a breast pump.

Not already using a breast pump. Can speak, read and write in English (or Chinese for Beijing centre or Russian for Moscow centre)

Exclusion Criteria:

Mothers are ineligible to join the study:

If they are mixed or formula feeding. Have an illness that may prevent them from expressing breast milk. Are not willing to be randomly assigned to the pump or the control group Already expressing milk regularly.

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