cyrilzakka/clinical-trials huggingface dataset:
The Improving Care in Chronic Obstructive Lung Disease Study A Cluster Randomized Trial

Background The Swiss health ministry launched a national quality program "QualiCCare" in 2011 to improve healthcare for patients with COPD.

The aim of this study is to determine whether participation in the COPD quality initiative ("QualiCCare") improves adherence to recommended clinical processes and shows impact on patients COPD care and on quality of life in patients with COPD.

The care in obstructive lung disease study (CAROL) is a cluster-randomized controlled trial with randomization on the practice level. Thirty practices will be randomly assigned to equally sized intervention group or control group.

Each General Practioner (GP) of a practice will approach consecutively and regardless the reason for the current encounter, COPD patients diagnosed by spirometric evaluation (FEV1/ FVC \< 0.70), aged 45 years older, with a smoking history of = 10 pack-years (PY). GPs in the intervention group will receive "QualiCCare" education, which addresses knowledge, decision-making and behavioural aspects as well as delivery of care according to COPD quality indicators and evidence based key elements. In the control group no educational intervention will be applied and COPD patients will be treated as usual. The study period is one year.

The primary outcome measure is an aggregated score of relevant clinical processes defining elements in the care of patients with COPD: smoking cessation counseling, influenza vaccination, motivation for physical activity, appropriate pharmacotherapy, patient education and collaborative care.

Eligibility Criteria:
Inclusion criteria:

* Males and females = 45yrs of age and
* Smoker or ex-smoker (with at least 10 PY) and
* Obstruction in spirometry FEV1/FVC\< 0.7

Exclusion criteria:

* No obstruction in spirometry (FEV1/FVC \> 0.7) or
* Patients with history of asthma or hay fever or
* Other concomitant pulmonary disease or
* Patients with malignancies of any other system and/or other severe disease with an estimated life expectancy of less than six months or
* Insufficient German language skills or
* Patients who contact the practice for emergencies only or as a substitute practice
Multi-Gyn FloraFem Study for Treatment of Vulvo Vaginal Candidiasis Symptoms

Women diagnosed with Vulvovaginal Candidiasis by the health care professional will be enrolled in the study. All participants should fulfil inclusion and exclusion criteria.

The study product will be used for 5 days, once a day. The doctor will evaluate the patients before and at the end of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with Vulvovaginal Candidiasis confirmed by:itching, and/or burning, irritation, edema, redness, crumbly white discharge
* Aged \>18 years
* Signed written informed consent form
* Willing to comply to the follow-up schedule
* Subject affiliated to a health social security system.
* Female of childbearing potential should use a contraceptive regimen recognized as effective since at least 12 weeks before screening visit, during all the study and at least 1 month after the study end.

Exclusion Criteria:

* Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, bacterial vaginosis or aerobic vaginitis (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
* Current genital malignancies
* Chemotherapy for any reason in last 6 months
* Radiotherapy in the genitourinary system in the last 12 months
* Pregnancy or currently attempting to conceive
* Lactation
* Use of other treatment for vaginal conditions during the course of the clinical investigation
* Known allergies to ingredients of the product
* Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation
Building Partnerships With First Responders to Improve Delivery and Access of Mental Health Services

This study will conduct qualitative interviews with firefighters and EMTs/ paramedics across Arkansas. To address this aim, opt-in methods will be used to recruit a diverse group of firefighters and emergency medical technicians/paramedics from across Arkansas to participate in qualitative interviews, defined as focus groups and individual interviews. Through this work, this will generate the scientific foundation to develop a comprehensive, mental health service model that will motivate engagement in services by diverse first responders.

Firefighters and emergency medical technicians (EMTs)/ paramedics respond to more than 50 million emergency calls in the U.S. every year. The daily operations and experiences that are expected and accepted as part of their job expose them to various traumatic events. The nature, frequency, and intensity of duty-related traumatic exposures place these first responders (FRs) at significant risk for mental health (MH) problems, such as post-traumatic stress disorder (PTSD) and suicide. However, due to the stigma of mental illness and the culture of self-reliance and strength that surrounds FRs, few are willing to seek help. There will be a two-stage exploratory, qualitative study that will use a statewide community-engagement approach to conceptualize a MH service model that would motivate FRs to be more engaged in services. In Stage 1, qualitative interviews with firefighters and EMTs/ paramedics will be conducted across Arkansas. In Stage 2, product development process grounded in these findings to conceptualize a MH service model feasible for implementation in real world settings. (Protocol for Stage 2 will be submitted for IRB approval at a later time.) Stage 1, Specific Aim: Identify FRs' preferences and priorities regarding MH service and delivery methods, including the feasibility, acceptability, and value of each method. To address this aim, we will use opt-in methods to recruit a diverse group of firefighters and EMTs/paramedics from across Arkansas to participate in qualitative interviews, defined as focus groups and individual interviews. After all qualitative interviews have been analyzed, a series of product development activities in Stage 2. Through this work, the scientific foundation to develop a comprehensive, MH service model that will motivate engagement in services by diverse FRs. This study's findings will guide a multi-stage, research agenda that will include development and pilot testing of the MH service model, ultimately, promoting engagement in MH services may decrease suicide rates and improve the overall MH outcomes among this at-risk population.

Eligibility Criteria:
Inclusion Criteria:

* ages 18 and over volunteer and career personnel active, inactive, and retired

Exclusion Criteria:

* Non- English speaking (due to the nature of focus group/interview discussions)
Emotional Intelligence in Patients With Addictive Disorder

The study aims to evaluate the level of emotional intelligence in patients diagnosed with substance use disorder and to evaluate the benefits in emotional skills after a brief intervention based on emotional intelligence.

Patients will be recruited by consecutive non-probabilistic sampling in the Addictions Day Hospital of the Addictions Unit of the Hospital de la Santa Creu i Sant Pau in Barcelona. The level of emotional intelligence will be assessed through the following measurement instruments: MSCEIT for the objective emotional intelligence coefficient and the TMMS-24 for the perceived emotional intelligence. Patients will attend 9 sessions of brief group intervention based on emotional intelligence and pre-post intervention differences in participants' TMMS-24 scores will be analyzed

Eligibility Criteria:
Inclusion Criteria:

* Substance Use Disorder (DSM-5)
* 18 to 80 years old

Exclusion Criteria:

* Presence of severe psychopathological alteration (including severe intoxication)
* Inability to understand the Spanish language or difficulties writing or reading
The Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus

The purpose of this observational, non-controlled, multicenter trial with a retrospective design is to evaluate the visual performance of one cohort of patients who received the EDOF MINI WELL® intraocular lenses following refractive lens exchange (RLE) or cataract surgery.

The study aims at evaluating the visual performance of the EDOF MINI WELL® in qualitative and quantitative terms of the progressive vision. The cohort of subjects includes all patients submitted in the six involved Centers. for the surgical procedure for cataract extraction or Refractive Lens Exchange (RLE) using the MINI WELL® with a pre-operative visit (from the day - 60 to day -1 before surgery) and a post-operative follow-up visit performed 30-60 days after implant.

Eligibility Criteria:
Inclusion Criteria:

* Any gender and age above 18 years
* Refractive lens exchange (RLE) or cataract surgery
* Symmetrical preoperative keratometric astigmatism \< 0.75 D
* Healthy corneas, not treated surgically

Exclusion Criteria:

* Previous corneal surgery (i.e. pterygium, refractive surgery)
* Eye diseases with visual acuity \< 20/32
* Pseudoexfoliation
* Abnormal pupil size and position.
* Use of contact lens 30 days before the preoperative visit.
* Corneal warpage
Feasibility and Efficacy of HABIT for Enhancing Daily Hand-Use Post Stroke

This experimental design will assess the feasibility \& initial effectiveness of HABIT - a novel occupational therapy to increase the daily hand-use of the affected upper extremity post stroke.

Assessments will be conducted at four time points: baseline, pre, post the HABIT intervention and follow-up (by phone) .

The goal of this study is to test the feasibility and efficacy of HABIT (Hand Activities Behavior Intervention) in increasing daily hand-use of the affected upper extremity among individuals with good motor ability post-stroke.

The aim of HABIT is to increase the daily use of the weaker hand in everyday activities by improving non-motor components (such as self-efficacy, raising the frustration threshold for performing tasks with the affected upper extremity, and creating opportunities for hand use). HABIT will include group discussions, analysis of challenges in using the affected upper extremity, home exercises, problem-solving and practice and dual-task activities. The intervention will focus on raising awareness, changing habits, and practicing the use of the affected upper extremity.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 and above residing in their own homes
* Hebrew speakers
* Up to 10 years post-stroke
* Mild upper extremity motor impairment but still report difficulty using their hand. This will be determined by a total score of 43/66, including the Hand subtest score of 7/14 points of the Fugl-Meyer Motor Assessment.
* No significant cognitive decline (score of 19 and above on Montreal Cognitive Assessment)
* Able to walk with or without assistive devices
* Able to provide informed consent by signing a consent form
* Full function of both hands and independent in daily function prior to stroke

Exclusion Criteria:

* Other neurological conditions or psychiatrists
* with moderate or significant proprioception deficit (Thumb Localization Test \>1)
Custom Surgical Tray in ACLR Procedure

In the Toulouse University Hospital, the Custom Surgical Tray (CST) were not referenced. The nurse had to prepare and open all the components of the procedure separately. This is a long and wasteful process.

CST brings together all the single-use medical devices necessary for an intervention, including draping and dressing elements, in the same single packaging.

Following the new local call for tenders on draping kits, and with the aim of standardizing and rationalizing practices, the implementation of CST within the requesting blocks whose orthopedic and traumatology block has been validated.

The hypothesis is that the CST would save time on preparing the trolley and on opening single-use equipment in the room while limiting the amount of waste.

To determine the social impact, the study assess the quality of life at work by measuring the difference, after implementing CST, in time needed for preparation of the trolley before entering the OR, for opening the instruments necessary by the surgical and circulating certified perioperative nurse (CNOR) in the Operating Room (OR), and for sorting the waste derived from the instrument's packages between plastic and paper after the intervention. In addition, the study assessed the biomechanical risk factors related to musculoskeletal disorders by evaluating the number of movements made by the CNOR when opening the instruments and sorting the waste, with and without CST. Finally, the study evaluate CNOR and surgeon's satisfaction after the implementation of CST.

To determine the ecologic impact, the difference in the number and weight of waste due to packaging of the disposable instruments, with and without CST was evaluated.

To determine the economic impact, the difference in cost of the instruments used, with and without CST was evaluated.

The hypothesis is that the use of CST enhances Sustainable Development (SD) by maintaining social development and environment protection, despite a possible additional cost.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old patients
* patient necessitating a Anterior Cruciate Ligament reconstruction

Exclusion Criteria:

* patient refusing to participate.
A Clinical Investigation to Confirm the Ability of MammoWave in Breast Lesions Detection

This is a multicentric, single arm, prospective, stratified by breast density clinical investigation to confirm the ability of the microwave mammogram 'MammoWave' to detect breast lesions.

MammoWave is a innovative medical device, class IIa marked CE, which uses microwaves instead of ionazing radiation (x-ray) for breast lesions. Specifically MammoWave employs a novel technique wich generates images by processing very low power (\<1mW) microwave.

The MammoWave exam takes few minutes for breast and is performed with the patient lying in a confortable facing down position.

MammoWave is safe to be used at any age, in any condition (pregnancy, specific illness and for unlimited number of times.

The maximum number of participants to the clinical investigation will be 600 (for all the sites). The study will be composed of two phases: a preliminary phase to 'optimize the imaging algorithm for each apparatus installed at each centre', where 15 volunteers (in each centre) having breast with no lesions (NL) will be examined by MammoWave. In the second phase, the remaining people will be enrolled (BL will be 50% of total) and examined by MammoWave by the clinical investigator, and results will be compared with the effective diagnosis already obtained by standard clinical methods. BL includes malignant lesions (BC) and benign lesions, and may be palpable or non-palpable lesions. BL includes also isolated clustered microcalcifications.

The primary gol of the clinical study is to assess MammoWave's ability in BL detection.

The study will involve investigational sites in Italy, Germany and Spain.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed consent Form
* Women
* Adult ≥ 18 years old
* Having a radiologist study output obtained using mammography within the last month. Such radiologist study output may be integrated with ultrasound and /or magnetic resonance imaging output if deemed necessary by the responsible investigator and when available. The radiological output will be integrated with histological one if deemed necessary by the responsible investigator and when available.
* Patients willing to comply with study protocol and recommendations

Exclusion Criteria:

* Patients who belong to any vulnerable group
* Patients with implanted electronic devices
* Patients who have undergone biopsy less than one week before MammoWave scan
* Patients with nipple piercings (unless they are removed prior to examination)
* Pregnancy or breastfeeding
Yogic Breathing and IBS

Adults with irritable bowel syndrome (IBS) are being randomized to a yogic breathing or control condition. Participants randomized to the yogic breathing group will be asked to complete a 2-minute yogic breathing video 5 to 7 days per week at home for 4 weeks and control group participants will be asked to maintain their current activities. Participants in this group will be given access to the yogic breathing video at the end of the 4-week control period. IBS symptoms and autonomic and vascular function will be assessed at baseline and at the end of week 4 in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Must have a formal diagnosis of IBS and not be enrolled in any other clinical trials.

Exclusion Criteria:

* 1) current, regular practice of yogic breathing at least 5 minutes per day and 2) chronic obstructive pulmonary disease
Lifetech CeraFlex™ Post-Market Surveillance Study

The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™ occluders for patients with secundum type Atrial Septum Defect (ASD), Patent Foramen Ovale (PFO) or Patent Ductus Arteriosus (PDA).

This study is designed as a post-market, prospective, multi-center, non-interventional clinical study to collect data regarding procedural success, clinical performance and cost-effectiveness of the Lifetech CeraFlex™ occluders in patients with secundum ASD, PFO and PDA.

Patients will be recruited in up to 12 investigational centers located in Europe and the Middle East.

To avoid bias in the study population the following measures will be taken:

* All sponsor or designee and external study personnel will be trained on the latest version of the Clinical Investigation Plan (CIP) and related study materials.
* Patients will be screened to confirm study eligibility with pre-defined inclusion/exclusion criteria prior to enrollment.
* This study will follow consecutive screening and enrollment.

The study will enroll 120 patients. The patient population will consist of up to approximately 40 consecutive enrolled patients with a confirmed secundum type ASD, up to approximately 40 enrolled patients with PFO and up to approximately 40 enrolled patients with PDA resulting in a significant shunt and in need of an intervention. These estimated upper limits per therapy group can however be exceeded depending on the enrollment trend, to account for a minimum of 10 patients to be enrolled per therapy group and a total study population of 120 enrolled patients.

Eligibility Criteria:
Inclusion criteria

To participate in this study, the patient must meet all of the following inclusion criteria:

1. Confirmed ASD, PFO or PDA and patient characteristics consistent with the corresponding IFU and sizing guidelines;
2. The patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has signed the applicable Consent Form, approved by the appropriate Ethics Committee (EC)/IRB (where required);
3. The patient agrees to comply with requirements of the study including the 12 months followup.

Exclusion criteria

Patients will be excluded if any of the following conditions apply:

1. Any contra-indication mentioned in the corresponding IFU;
2. Currently participating in another investigational drug- or device study.
Activation Innate Immune System in Type 1 Diabetes

Hyperglycemia is a well-known cardiovascular risk factor. It has also been shown that episodes of hyperglycemia increase the risk for cardiovascular diseases despite return to normoglycemia, a phenomenon termed 'glycemic or metabolic memory'. The molecular mechanism underlying this phenomenon remains unclear.

Cardiovascular events, such as myocardial infarction and stroke are caused by atherosclerosis, which is characterized by low grade inflammation of the vascular wall, including accumulation of innate immune cells such as monocytes and macrophages.

The investigators hypothesize that chronic hyperglycemia shifts intracellular metabolism of innate immune cells towards glycolysis and changes the epigenetic state of (progenitors of) innate immune cells (monocytes and macrophages), which reprograms these cells towards a more aggressive, pro-atherogenic phenotype, thereby accelerating atherosclerosis.

In this study, the investigators aim to test this hypothesis. This research will reveal whether the innate immune cells of patients with chronic hyperglycemia show a durable shift in intracellular metabolism and epigenetic changes and whether this associates with vascular inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Group 1 and 2 (patients with type 1 diabetes):
* Diagnosis based on clinical criteria
* Duration of diabetes ≥10 years
* Age ≥20 years, ≤ 60 years
* Group 1: HbA1c \>64 mmol/mol
* Group 2: HbA1c ≤64 mmol/mol
* Written informed consent

Group 3 (healthy controls):

* Absence of disease, no use of medication
* Matched for age, gender and BMI
* HbA1c \<42 mmol/mol
* Written informed consent

Exclusion Criteria:

* Inability to provide informed consent
* Smoking
* Specific Medication use:

  * Use of immunosuppressive drugs
  * Use of statins \< 2 weeks before performing PET-CT (Those that use statins will be asked to discontinue for two weeks. This can be safely done in the context of primary prevention.)
  * Use of acetylsalicylic acid
* Previous cardiovascular events (ischemic stroke/TIA (transient ischemic attack), myocardial infarction, peripheral arterial disease)
* Auto-inflammatory or auto-immune diseases
* Current or recent infection (\< 3 months)
* Previous vaccination (\< 3 months)
* Renal failure (MDRD \<45)
* BMI\>30 kg/m2
* Pregnancy
* Claustrophobia
* Severe hypoglycaemia \< 1 week before PET-CT
The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms

The purpose of this study is to assess Mixhers HERTIME supplements efficacy in alleviating menstrual cycle symptoms.

All participants, after providing written informed consent, will drink a daily self-administered powder-mix supplement in water of either placebo or Mixhers HERTIME for 120 consecutive days. Surveys will be administered electronically to each participant in the first month to assess baseline menstrual cycle symptoms. In addition, before starting the supplement, participants will take the electronic survey "The Premenstrual Symptoms Screening Tool". During the first month of taking the supplement, participants will take an allergy and constitutional symptom survey electronically to assess for any adverse reactions to the product. Each month for four months, participants will complete an electronic survey assessing menstrual cycle symptoms after a menstrual cycle is completed.

Eligibility Criteria:
Inclusion Criteria:

* Must be biologically female, must have a regular menstrual cycle (defined as a menstrual bleed every 23-35 days), must be a student, staff, or faculty member at Midwestern University Glendale, Arizona campus

Exclusion Criteria:

* not pregnant or planning to become pregnant, must not be on anticoagulants, must not have allergies to lemon or stevia