cyrilzakka/clinical-trials huggingface dataset:
Patients Treated by the Danish Emergency Medical Services Following Non-drowning Water Rescues From 2016 to 2023

Since 2015, all Danish prehospital EMS have used the nationwide Prehospital Electronic Medical Record (PEMR). In 2023, the investigators developed the Danish Drowning Formula (DDF), a text-search algorithm designed to search the unstructured text fields in the electronic medical records with comprehensive search criteria to identify all potential water-related incidents. This protocol describes the first study to analyse the prehospital data from a nationwide Danish cohort of patients treated by the EMS from 2016 to 2023 following non-drowning aquatic rescues.

Purpose The purpose of this study is to establish recommendations towards specific educational, preventative, or rescue strategies to reduce the number of aquatic rescues in Denmark (e.g., campaigns targeting high-risk groups, or fencing, allocating rescue equipment, or establishing lifeguard stations in high-risk areas). This may not only enhance prevention of aquatic rescues but also decrease the mortality and the total number of drowning incidents in Denmark.

Objectives The primary objective is to estimate the yearly incidence of patients treated by the Danish EMS following a non-drowning aquatic rescue from 2016 to 2023 and calculate the aquatic rescue to drowning ratio. The secondary objectives are to characterise the rescues (e.g., lay rescuer or professional rescuer, use of equipment) and to report the spatial distribution.

Study design This study is a nationwide registry-based study with data from the Danish nationwide PEMR from 2016 to 2023.

Methods Since 2015, all Danish prehospital EMS have used the nationwide Prehospital Electronic Medical Record (PEMR). In 2023, the investigators developed the Danish Drowning Formula (DDF), a text-search algorithm designed to search the unstructured text fields in the electronic medical records with comprehensive search criteria to identify all potential water-related incidents. This study will be the first to analyse the prehospital data from a nationwide Danish cohort of patients treated by the EMS from 2016 to 2023 following non-drowning aquatic rescues.

Eligibility Criteria:
Inclusion Criteria:

* All the patients registered in the Danish Prehospital Electronic Medical Record from 2016-2023 will be screened by the Danish Drowning Formula and the medical records containing one or more trigger words will be extracted for manual validation.
* All records where the patient was immersed or submersed in liquid but did not experience mild, moderate, or severe respiratory impairment following the drowning process will be included.

Exclusion Criteria:

* All records where the patient was immersed or submersed in liquid and did experience mild, moderate, or severe respiratory impairment following the drowning process).
* All records where the patient was not immersed or submersed in liquid.
Mechanical Thrombectomy of Acute Ischemic Stroke Anterior Circulation Distal Vessel Occlusion

Ischemic stroke continues to be of the leading causes of disability and death. Distal vessel occlusion one of most presenting and disabling varieties of ischemic stroke. Distal vessel occlusion stroke is a type of ischemic stroke that affects the small arteries in the brain, usually beyond the M2 segment of the middle cerebral artery. These strokes can cause various neurological symptoms depending on the location and size of the occluded vessel and the extent of the brain tissue damage

DMVOs are defined by the Distal Thrombectomy Summit Group consensus statement as thromboembolic occlusion of the anterior cerebral artery, M2-M4 middle cerebral artery (MCA), posterior cerebral artery (PCA), posterior inferior cerebellar artery, anterior inferior cerebellar artery or superior cerebellar artery. It is estimated that 25-40% of all AIS is due to DMVO.Though distal vessel occlusion associated with poor disabling comorbidities'.With different aetiology weather primary Embolic from (heart, carotid or aorta),thrombotic (atherosclerotic, hypertension or Diabetes ,smoking \&hyperlipidaemia) or Secondary distal vessel occlusion that occurs as a complication of a proximal large vessel occlusion, either spontaneously or after treatment with intravenous thrombolysis or endovascular thrombectomy. This can be due to thrombus fragmentation and migration or incomplete reperfusion of the affected vascular territory . Endovascular thrombectomy is well established as a highly effective treatment for acute ischemic stroke (AIS) due to proximal, large vessel occlusions (PLVOs). Recent advances in stent retriever and aspiration catheter technology are more promising results to reach more distal vessels, with a good outcome. However, MT in M2 emerging with different technique using stent Retriever or aspiration or both nowadays, evidence of other MT in distal vessel occlusion is poor.

Eligibility Criteria:
Inclusion Criteria:

* a. Inclusion criteria:

  1. Diagnosis of an acute ischemic stroke due to an occlusion of the anterior cerebral artery (ACA) in the A1-A3 segment 2. Diagnosis of an acute ischemic stroke due to an occlusion of the middle cerebral artery in the distal M2 segment or the M3 segment.

Exclusion Criteria:

1. Posterior circulation small vessel occlusion
2. Tandem lesions with occlusion of the ipsilateral ICA were excluded.
Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents

The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents.

The study duration will be up to 12 months for all participants.

The study duration will be approximately 12 months for all participants

Eligibility Criteria:
Inclusion Criteria: - Aged 18 to 25 years or 10 to 17 years on the day of inclusion

* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator.
* Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
* Known or suspected congenital or acquired immunodeficiency
* History of any Neisseria meningitidis infection
* At high risk for meningococcal infection during the study
* Individuals with active tuberculosis
* History of Guillain-Barré syndrome
* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Computerized Evaluation of the Endometrial Myometrial Junction During a Natural Menstrual Cyle.

The investigators aim to evaluate the width of the endometrial myometrial zone in participants during natural menstrual cycle by using specific computerized application on 3 dimensions sonographic images of their uteri.

The uterine endometrium and the uterine myometrium have different acoustic characterization in transvaginal ultrasound(TVS).TVS can also demonstrate the interface between these tissues - the endometrial myometrial zone(EMJ) .This is optimally achieved in 3 dimensions images in a coronal section of the uterus.A specific computerized algorithm was developed in our unit by using MATLAB software for the quantitative measurements of the EMJ width in different uterine planes.The investigators aim to evaluate changes in the width of the EMJ in different uterine planes in participants during natural menstrual cycle .

Eligibility Criteria:
Inclusion Criteria:patients with regular menstrual cycles -

Exclusion Criteria:patients on contraceptive pills.patients after uterine surgery

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Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills

The aim of this research will be to perform a small randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of primary care patients with type 2 diabetes and low literacy and/or numeracy.

Results of the National Adult Literacy Survey (NALS) suggest that over 90 million adult Americans have poor quantitative skills. Numeracy, the ability to understand and use numbers and math skills in daily life, may be particularly important to patients with diabetes because caring for diabetes often requires self-management skills that rely on the daily application of math skills, such as counting carbohydrates, interpreting blood glucose monitoring, applying sliding scale insulin regimens, and calculating insulin to carbohydrate ratios. Presumably diabetes patients with poor numeracy have more difficulty with self-management and are at risk for poorer clinical outcomes, but to date, there are no published studies that rigorously examine the role of numeracy in diabetes. We have recently completed the initial development of a new scale to measure numeracy in patients with diabetes: the Diabetes Numeracy Test (DNT).

The aim of this research will be to perform a small randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor literacy and numeracy skills among a sample of patients with type 2 diabetes and low numeracy or literacy skills. We hypothesize that a group of patients with poor literacy and/or numeracy who are taught self-management skills that accommodate their poor numeracy will have: (1) improved treatment satisfaction and perceived self-efficacy, (2) improved performance in self-management tasks, and (3) improved glycemic control compared to a control group that receives usual education and care.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Type 2 Diabetes
2. most recent A1C \>= 7.5%
3. Referred to the Diabetes Care Program for diabetes care
4. Age 18-85; 5. English Speaking.

Exclusion Criteria:

1. Patients with corrected visual Acuity \>20/50 using a Rosenbaum Pocket Vision Screener
2. Patients with a diagnosis of significant dementia, psychosis, or blindness.
Calf Muscle Tightness in Flat Foot Subjects

The purpose of the current work is to determine the prevalence of calf muscle tightness in asymptomatic flat foot subjects.

Pes planus (Flat foot) deformity is a common chronic foot and ankle condition characterized by flattening of the medial longitudinal arch (MLA), rearfoot valgus and abduction of the midfoot on the hind foot.

A flexible pes planus is caused by tibialis posterior dysfunction, ligament loosening, Achilles tendon shortening, and weakness of the intrinsic foot muscles. These deformations cause plantar flexion and adduction of the talus bone and valgus of the calcaneus bone.

Up to our knowledge:

1. No previous studies investigated whether all flat foot is usually associated with gastrocnemius and soleus muscle tightness or it is a random association.
2. And whether tightness of gastrocnemius and soleus is highly found in all cases of flat foot.

Consequently this study is conducted.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects should have flexible flat foot.
2. Age between 20 and 40 years.
3. Navicular drop of more than 10 mm.
4. Body Mass Index from 18.5 kg/m2 to 29.9 kg/m2.
5. Subjects will sign the written consent form after the aim and methods of the study are explained clearly.

Exclusion Criteria:

1. Subjects with history of foot and ankle surgery, trauma, fracture or dislocation.
2. Subjects with congenital deformities in the ankle and foot.
3. Subjects with systemic or neurologic diseases that could affect lower extremity biomechanics.
Trial of PICO Versus Standard Care in Chronic and Sub-acute Wounds

Randomised Controlled Trial of PICO (a portable Negative Pressure Wound Therapy) versus standard care in patients with chronic and sub-acute wounds. Sample size 100 patients to investigate Time to healing, health economic and patient reported outcomes.

The current study is being conducted to assess the clinical and cost effectiveness of managing patients with a chronic or sub-acute wound in a community setting with PICO and to explore the patient experience and issues of concordance that affect patients treated with PICO. The study will provide information on the level of clinical benefit that PICO can deliver in the population studied in order to justify a sample size for a definitive evaluation of PICO and the study will further assess wound types that may benefit from treatment with PICO.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old
* Males and females. If female, they must not be pregnant or lactating. If female and of reproductive age, a pregnancy test will be provided.
* The patient or their legal representative (if the patient is incapable of giving legal consent), is able to understand the trial and is willing to consent to the trial.
* Patients with sub-acute or chronic wounds (diabetic foot ulcer, pressure ulcer, venous leg ulcer, or other chronic) suitable for treatment with a PICO dressing.
* Wound duration ≤52 weeks - Amended to remove criteria.
* Wound area range ≥5 cm2 at start of screening period
* Wound maximum linear dimension ≤ 15cm
* Able to use English for the interview

Exclusion Criteria:

* Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing).
* Wounds which have an infection which is not being treated with systemic antibiotics.
* Wounds which are actively bleeding.
* Exposure of blood vessels, organs, bone or tendon at the base of the reference wound
* Exclude undermining or tunnelling present or suspected in the wound
* Use of negative pressure device on wound in the last 30 days. Amended to remove criteria
* Malignant wounds/malignancy in the wound
* Systemic infection not being treated with systemic antibiotics
* Simultaneous treatment with other experimental wound care procedures, biologics or devices
* Patients with a known history of poor compliance with medical treatment.
* Patients who have participated in this trial previously and who closed or were withdrawn.
* Patients who are unable to understand the aims and objectives of the trial.
High-need Community Older Adults Care Delivery Model

This study is proposed to: (1) establish a "High-need Community Older Adults Care Delivery Model" (HCOACDM) as a guide to handle complex needs of the high-need community older adults by the care managers at community care centers; and (2) evaluate the effectiveness of applying the HCOACDM to improve the functional ability, quality of life (QOL), depressive symptoms, healthcare and social service utilizations, and care delivery satisfaction of the high-need community older adults.

A cluster randomized controlled trial with repeated measures design will be conducted to test the effectiveness of six-month HCOACDM on the functional ability, QOL, depressive symptoms, healthcare and social service utilizations, and care delivery satisfaction of the high-need community older adults. The high-need community older adults, screened based on the "High-need Community Older Adults Screening Scale" (HCOASS), will be cluster randomized based on the community care centers, to the intervention group (4 centers) or comparison group (4 centers). Intervention group will receive six-month HCOACDM care and comparison group will receive original routine care provided by the care managers at community care centers. One pre-test and two post-tests, three months apart, of outcome measurements will be conducted on all participants. Moreover, individual semi-structured interviews will be carried out to explore opinions and suggestions toward the HCOACDM of the care managers in intervention group. It is expected that the developed HCOACDM will be useful to provide the long-term care for community older adults and enhance the quality of diverse and complex care delivery system.

Eligibility Criteria:
Inclusion Criteria:

* lived in the community at least three months
* over 65 years old
* fluently communicated in Mandarin or Taiwanese
* screened by the High-need Community Older Adults Screening Scale (HCOASS) as high-need older adults

Exclusion Criteria:

* diagnosed as dementia
Food Structure of Pulses and Satiety

Diets containing (whole) pulses have been associated with the potential to increase satiety (and acute food intake). In vitro digestion studies of pulses have shown that (thermal) processing has the potential to modulate macronutrient digestion kinetics. Changes in food (micro)strucutral properties have been identified to retard nutrient release, with a possible effect on appetite sensations. Based on distinct in vitro digestion behaviour, two differently processed pulse meals were chosen to be investigated in humans with the aim to confirm in vitro findings and gain a mechanistic understanding of the influence of structural aspects of pulses on appetite sensations.


Eligibility Criteria:
Inclusion Criteria:

* BMI (between 18 and 30 kg/m2)
* Healthy men
* Age between 18-45
* Regular breakfast eaters (≥ 4 times a week)
* No allergies

Exclusion Criteria:

* Chronic diseases (diabetes, cardiovascular diseases, or other metabolic diseases that could affect the study)
* Use of daily prescription medicine
* Use of dietary supplements that could affect appetite (used within the last month up to or during the study)
* Smoking or use of any nicotine product (used daily within the last three months up to or during the study)
* Over 10 h of strenuous physical activity per week
* Participation in other clinical studies (participation within the last month up to the study or during the study)
* Food allergies
* Weight change of more than ±3 kg from screening until the trial will be completed
* Inability to comply with the procedures required by the study (including an 8-10 h fast before the trial days).
Utilization of Simulated Grid (SimGrid™) Technology for the Reduction of Ionizing Radiation Dose on X-ray Examination in Obese Patients

The purpose of this research study is to learn if a new imaging processing technique called Simulated grid (SimGrid™) will help in getting better quality X-ray images in obese subjects. The GM85 digital radiography machine will be used to obtain X-ray images.


Eligibility Criteria:
Inclusion Criteria:

* Obese adult volunteers with Body-Mass Index (BMI) exceeding 30
* subjects that require at least one X-ray for continuation of care

Exclusion Criteria:

* subject who is known to have lung disease(s) which would interfere with the interpretation of the chest radiography image
* subject who is pregnant or breastfeeding
Fiber Use in Pediatric Short Bowel Syndrome

Short bowel syndrome (SBS) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. Infants with short bowel syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the lack of effective therapies.

Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children.

The purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with SBS

Short bowel syndrome (SBS) is a form of disease that results from removal of a significant portion of the intestine leading to poor nutrient absorption. Infants with short bowel syndrome suffer from diarrhea and poor growth. The care of these infants is limited by the lack of effective therapies. As the intestine tries to grow back some of its length, a process that can take many months, these infants become dependent on intravenous (IV) nutrition in order to survive. Liver disease and sepsis (a blood stream infection) are common complications of IV nutrition and are the two most common causes of death in this population. Therefore, clinicians have tried different ways to improve feeding and shorten the amount of time of IV nutrition, for example continuous feedings through the intestine, use of partly digested formulas and change in diet.

Soluble fiber (guar gum) is an indigestible form of sugar that is mostly contained in fruits and vegetables. Soluble fiber can reduce the severity and duration of persistent (constant) diarrhea in children.

The purpose of this research study is to evaluate the many effects of fiber added in the diet of infants with SBS.

Eligibility Criteria:
Pediatric infants (less than 1 y of age) who

1. Have Short Bowel Syndrome defined by a history of congenital or surgical loss of intestinal absorptive function resulting in parenteral nutrition dependency of longer than 30 days;
2. Are receiving at least 20% of their caloric needs from enteral nutrition and have been on enteral nutrition for at least 1 week following intestinal resection;
3. Have increased stool output as manifested by watery stools (3-12/day) and increased ostomy output (20-50 cc/kg/day);
4. Have not received antibiotics, probiotics or prebiotics for 2 weeks prior to study entry;
Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional Hernia

Incisional hernia is one of the most common complications of abdominal surgery and carries a significant burden for both patients and the economic health service. However, no consensus for the surgical treatment of incisional hernia in contaminated field is currently available. The purpose of the COMpACT-BIO study is to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair.

The current standard of incisional hernia repair is reinforcement with permanent synthetic mesh. However, permanent synthetic mesh is contraindicated in contaminated surgical field due to higher risk of postoperative infection. In order to resist to infection, absorbable meshes, such as biological and biosynthetic meshes, have been developped. However, some controversies exist about the clinical benefit of biological meshes in the long term. Reasons for theses controversies are their overall risk of complication and recurrence and the lack of consensus in which surgical technique to apply. Moreover, the financial cost of biological meshes is very high. Recently developed, biosynthetic meshes appear to be a promising option ; Compared to biological meshes, they seem to have several advantages. However, such data demonstrating the beneficial use of biosynthetic mesh in contaminated incisional hernia repair is not available. In this regard, the COMpACT-BIO study aims to investigate the clinical and economic benefit of the use of biosynthetic mesh in contaminated incisional hernia repair in comparison to the standard of repair. This is a multicenter, prospective, longitudinal and randomized study, which also offers a standardized technique of repair.

Eligibility Criteria:
All the following inclusion criteria must be fulfilled:

* Age ≥18 years old
* Physical status ASA \< 4
* Patient with a mid-line IH
* Patient presenting with an IH without loss of domain
* Surgical indication in elective surgery
* "Potentially contaminated" grade III surgical environment according to the classification of the modified VHWG
* Cure of mid line IH feasible according to the defined standard technical modality (placement of a retromuscular prosthesis)
* No emergency surgical procedure
* Status of social insured or entitled to a social insurance
* Informed and signed consent of the patient after clear and appropriate information

The exclusion criteria are as follows:

* One or multiple incisional hernia out of the midline incision
* Pregnancy, breastfeeding, parturient or childbearing patients without contraception
* Known allergy to tetracyclines;
* Persons protected by law