cyrilzakka/clinical-trials huggingface dataset:
Pressure Sore Prevention Strategy for the Prone Position

The aim of this clinical trial is to determine whether 5-layer hydrocellular dressings are effective in preventing the development of pressure sores during prone positioning in the intensive care unit. The main questions it aims to answer are:

- are hydrocellular dressings the best strategy for preventing pressure sores? is this strategy simpler and less costly? The researchers will compare hydrocellular dressings with hydrocolloid dressings to find out whether they are more effective in preventing the development of pressure sores in the prone position.

Participants will be given either hydrocellular or hydrocolloid dressings, and caregivers will assess whether or not pressure sores develop after prone positioning.

Hydrocellular dressings will be compared with hydrocolloid dressings to determine their effectiveness in preventing pressure ulcers during ventral decubitus in intensive care. The dressings will cover the skin in at-risk areas, and caregivers will assess whether or not pressure sores develop in these areas after prone positioning. The stage of these pressure sores will also be assessed.

The time spent on each strategy and the cost per strategy will also be evaluated. Dressings will be applied for the entire period during which participants are placed in the prone position. If they develop pressure sores during this period, they will be followed up until their discharge from intensive care to study the evolution of these pressure sores.

Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Moderate to severe acute respiratory distress syndrom (Arterial oxygen pressure /Inspired Fraction of oxygen ratio \< 200) requiring at least one VD session.
* Affiliated to the French social security system
* Sedated patient on mechanical ventilation

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patient under guardianship or trusteeship
* Minor patients
Video-Assisted Surgery or Talc Pleurodesis in Treating Patients With Malignant Mesothelioma

RATIONALE: Video-assisted surgery to remove part of the tissue layer covering the inside of the chest cavity may be effective in treating pleural effusion and cause less damage to normal tissue. Talc pleurodesis may keep fluid from building up in the chest cavity. It is not yet known which therapy is more effective in treating pleural effusion caused by malignant mesothelioma.

PURPOSE: This randomized phase III trial is studying video-assisted surgery to see how well it works compared with talc pleurodesis in treating patients with malignant mesothelioma.

OBJECTIVES:

Primary

* Compare the effectiveness of video-assisted thoracoscopic cytoreductive pleurectomy vs talc pleurodesis, in terms of 1-year survival, in patients with suspected or proven malignant mesothelioma.

Secondary

* Compare the control of pleural effusion in these patients.
* Compare procedure-related complications in these patients.
* Compare the symptoms and quality of life of these patients at 3, 6, and 12 months after treatment.
* Compare the length of hospital stay for these patients.
* Compare the exercise tolerance of these patients at 3, 6, and 12 months after treatment.
* Determine the cost to the health service, in terms of resources used for procedures, hospital bed usage, and cost of primary and secondary care over 12 months.

OUTLINE: This is a multicenter study. Patients are stratified according to risk (high vs low). Patients are randomized to 1 of 2 treatment arms.

* Arm I (video-assisted thoracoscopic \[VAT\] cytoreductive pleurectomy): Patients undergo VAT cytoreductive pleurectomy either at the time of biopsy or after confirmation of biopsy results.
* Arm II (talc pleurodesis): Patients undergo talc pleurodesis via an indwelling intercostal chest drain or via thoracoscopy either at the time of biopsy or after confirmation of biopsy results.

Quality of life, complications, and resource use are assessed at baseline and at 1, 3, 6, and 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Confirmed or suspected mesothelioma

  * Any subtype allowed
* Pleural effusion must be present

PATIENT CHARACTERISTICS:

* Clinically fit and suitable for video-assisted thoracoscopic cytoreductive pleurectomy
* Prior malignancy allowed provided it no longer requires treatment AND patient has a confirmed diagnosis of mesothelioma

PRIOR CONCURRENT THERAPY:

* No prior attempted pleurodesis by any approach
Effect of the Copenhagen Plank on Aductional Strenght and Vertical Jump in Female Football Players

There is enough evidence to know the high incidence of groin injuries in soccer. Despite this, there is not enough about these in women's football. The researchers perform the Copenhagen plank to obtain an improvement in the improvement of adductor strength and the reduction of groin injuries

At present, there is enough evidence to know the high incidence of groin injuries in soccer. Despite this, there is not enough about them in women's football. Strengthening the adductor muscles is beneficial in preventing these injuries. The Copenhagen plank is beneficial in programs for the prevention and treatment of groin injuries. A randomized controlled trial was carried out. The sample was made up of 26 players between 18 and 31 years of age from the CAP Ciudad de Murcia soccer team. The experimental group (n=12) performed the Copenhagen plank protocol for 4 weeks, the control group continued their training as normal. Performance was assessed using the CMJ jump and the hip adduction strength test using manual dynamometry. 3 measurements were made.

Eligibility Criteria:
Inclusion criteria:

* Girls of legal age
* At least 4.5 hours of weekly training
* Active female soccer team players

Exclusion Criteria:

* Current injury
* Injury in the previous 6 months
Pharmacological Optimization by a Specialized Outpatient Consultation Team

Background Polypharmacy is a common condition among older adults and is a major issue of concern for its association with adverse drug reactions and adverse health outcomes, including falls, functional and cognitive impairment, frailty, and increased use of healthcare resources. Therefore, an appropriate interprofessional collaboration is essential to face this growing concern. In our outpatient clinic, we have initiated a new approach to provide specialized care for older adults based on a close collaboration between different professionals to optimize drug therapy. With the aim to assess the impact of this specialized outpatient clinic on patients' abilities, a prospective study will be conducted in community-dwelling older adults with polypharmacy.

Methods The present study will be conducted with geriatric outpatients with polypharmacy (defined as ≥ 5 prescribed medications at the time of inclusion) in the Navarra University Hospital, a Spanish Public tertiary University Hospital. At least 104 patients aged 75 years or older, with a life expectancy ≥ 3 months willing to provide informed consent will be recruited from the outpatient clinic. Drug optimization in the first consultation will be accompanied by subsequent face-to-face and/or telephone follow-up at intermediate (\~ 3 months) and end of study (\~ 6 months). The primary endpoint will be the change in functional and cognitive capacities measured at baseline and follow-up. Secondary endpoints will be the analysis of medication changes (i.e. number of medications and drugs, type of intervention, anticholinergic burden, and the number of STOPP/START criteria), change in patient's quality of life, rate of falling, and use of healthcare resources.

Discussion Regarding geriatric outpatients, studies in which medication review has been conducted by a multidisciplinary team (at least comprising a physician and a pharmacist) functional and cognitive patient's capacities have not been reported. What this study adds is the impact of a specialized consultation team focused on pharmacotherapy optimization in functional and cognitive abilities of community-dwelling older adults with polypharmacy. A multidisciplinary approach to polypharmacy could be an effective way for improving patients' functional and cognitive abilities. We expect that the association of different complementary professional roles working together will have a synergistic effect and will be an effective strategy for this purpose.


Eligibility Criteria:
Inclusion criteria:

* ≥ 75 years old
* Willing to provide informed consent
* Life expectancy ≥ 3 months
* Present polypharmacy (defined as ≥ 5 prescribed medications at the time of inclusion).

Exclusion Criteria:

* Refusal to sign the informed consent form by the patient/primary caregiver/legal guardian or inability to obtain it.
* Participation in a clinical trial related to medication.
* In the event of a no-show or cancellation of the appointment at the first visit.
Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery

Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.


Eligibility Criteria:
Inclusion Criteria:

1. KPS\>=60
2. histology confirmed invasive breast cancer
3. received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)
4. surgical margins negative
5. primary tumor ≤5cm in the largest diameter
6. no internal mammary node or supraclavicular node metastases or distant metastasis
7. can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy
8. for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date
9. for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy
10. patients signed written inform consent form

Exclusion Criteria:

1. ductal carcinoma in situ
2. prior neoadjuvant chemotherapy
3. prior breast cancer history
4. bilateral breast cancer
5. pregnant or during lactation
6. prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ
7. active collagen vascular disease
8. prior neoadjuvant hormone therapy
9. immediate ipsilateral breast reconstruction
Study of Long-term Efficacy and Mechanisms Underlying the Impact of a Web-based Sexual and Relationship Health Promotion Program With Young Adult Community College Students

Community college students are an underserved and at-risk population in terms of their sexual and relationship health. This is a three-arm randomized control trial to evaluate the long-term efficacy of a web-based sexual and relationship health promotion program among U.S. community college students (expected N = 2010) and explore the mechanisms underlying the program efficacy.

Community college students are an underserved and at-risk population in terms of their sexual and relationship health. One promising avenue for improving sexual decision making among this population is media literacy education (MLE). Though studies show MLE is an effective approach to sexual health promotion there is a need to better understand the mechanisms by which MLE programs impact health outcomes. The ultimate goals of this study are to 1) advance theoretical frameworks of media literacy to better understand the underlying mechanisms that lead to sexual health behavior change and 2) enhance the sexual and relationship health of community college students by identifying successful methods of health promotion and strategies to implement health programs at community colleges. This study is a three-arm randomized control trial (RCT) with 2010 community college students (ages 18-19) from 30 colleges across the U.S. All components of this study (i.e., interventions, surveys) are web-based.

Participating students will be randomized to one of three conditions: 1) students who receive a sexual health program grounded in MLE (Media Aware); 2) students who receive a sexual health program with no MLE; and 3) a wait-list control group. Participants will complete pretest, posttest, 6-month follow-up, and 12-month follow-up surveys to examine changes across the three groups in our primary outcomes (e.g., risky sexual behavior) and secondary outcomes (e.g., sexual health knowledge, rape myth acceptance, perceived realism of media messages).

Eligibility Criteria:
Inclusion Criteria:

* Students must be 18 or 19 years of age.
* Students must attend one of the community colleges from which this study is recruiting participants.
* Students must have an email address to receive study communication.
* Students must have access to a computer, tablet, or phone device with internet access as the questionnaires and programs are web-based.
* Students must be able to speak and read English because the study materials (e.g., questionnaires, programs) are in English.

Exclusion Criteria:

-
Behavioral Expressions in Alzheimer's Disease

Behavioral expressions, such as agitation and aggression, affect up to 90% of persons with dementia and are a major source of patient and caregiver distress, nursing home placement, anti-psychotic medication use, restraints, and increased health care costs. The purpose of the research study is to investigate whether reducing pain reduces behavioral expressions of Alzheimer's disease (agitation and aggression).

The research study will investigate if routine analgesic use will reduce behavioral expressions of dementia and pain in older adults with Alzheimer's disease or other dementias. Using a randomized, placebo-controlled, double-blind, cross-over design, the investigators will compare effects of a routine acetaminophen intervention (650 mg administered routinely by mouth three times per day for 4 weeks) to those of routine placebo (methylcellulose), also given for 4 weeks. The maximum dose to be administered will be 1,950 mg per 24 hours, which is below the current FDA recommendations (maximum dose of 3,000 mg/day).

Participants will be randomly assigned to either treatment or placebo group. The initial treatment phase will last for 4 weeks. At the end of the first 4 weeks, the treatment will be reversed after a 3 day washout period. During the 2nd intervention period, the study drug will be reversed (those receiving acetaminophen will receive the placebo drug and vice versa). The second treatment phase will last for 4 weeks. At the end of 2nd treatment phase, all study treatments will be discontinued

Eligibility Criteria:
Inclusion Criteria:

* documented diagnosis of Alzheimer's Disease or other dementia
* history of a typically painful condition, such as osteoarthritis, back pain, or other chronic musculoskeletal pain
* able to swallow oral medication
* history of aggressive or agitated behavior (defined as score of \> 39 on the Cohen-Mansfield Agitation Inventory),
* Mini Mental State Exam (MMSE) score \< 23

Exclusion Criteria:

* currently taking acetaminophen or opioid medication on a routine (regularly-scheduled, round the clock) basis
* receiving hospice care
* history of liver or renal disease
* drinks more than 3 alcoholic beverages per day
* known allergy or adverse reaction to acetaminophen
* bed-ridden or comatose
* currently taking warfarin
Metabolic and Functional Impact of Various Breakfast Models

In the present study the investigators compared the hormonal and metabolic effects of three meal loads very popular among Italian eating habits, both in the resting- and exercising state. Given the lack of time is considered a common barrier to exercise adherence, we wanted to identify a low dose of exercise capable to produce health benefits in the post-absorptive status elicited by three commonly consumed meal-models in Mediterranean countries. To this end, healthy young volunteers firstly underwent an oral glucose tolerance test (OGTT) and three meal tolerance tests. Secondly, in an extra set of experiments, subjects cycled at low intensity for the last 20 minutes of the same glucose/meal tolerance test. Glycemia, insulinemia, ghrelinemia, lipidemia, and satiety were measured throughout OGTT and each test-meal load.

The investigators evaluated postprandial responses (glucose, insulin, ghrelin, free fatty acids (FFA)) elicited by three diverse test-meal loads followed by a 20-min bout of low-intensity aerobic exercise were investigated. All subjects underwent a 50-g OGTT (A) and 3 test-meal loads: milk and cereals (B1); milk, apple and chocolate cream-filled sponge cake (B2); milk, bread, apple and hazelnut chocolate cream (B3). In the exercise trial, participants cycled for 20 minutes at 40% VO2max, 100 minutes after load ingestion.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 40 years
* normal body weight (BMI =18.5 - 24.9 according to NHLBI)
* stable diet

Exclusion Criteria:

* Diabetes, tipe 1 and 2 (ADA criteria)
* Glucose intolerance (ADA criteria)
* Dyslipidemia (ATP III according to NCEP)
* Metabolic syndrome
Memory for Health Research Findings

This experiment tests young (ages 18-35) and older adult (ages 60-80) participants. Participants will watch a brief video, will complete a memory task, and will complete measures about their beliefs.

Participants (360 young adults and 360 older adults) will complete a baseline beliefs measure and will then be randomly assigned to one of two study conditions. They will watch a 2.5-min video that presents research findings related to their health. Their memory for the video will be tested, and participants will also complete a demographic questionnaire and another survey about their beliefs. Participation will last 15-20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 35 years old or 60 to 80 years old
* Fluent English speakers

Exclusion Criteria:

-
Tissue Sodium in Patients With Psoriasis

Sodium can be buffered in the skin, which mechanism is altered during aging and in certain diseases such as hypertension. High salt environment can promote autoimmunity by expanding pathogenic IL-17 producing T helper (Th17) cells. Psoriasis is a relapsing and remitting inflammatory autoimmune disease affecting the skin and joints and involves proinflammatory Th17 cells. Here we tested the hypothesis if psoriatic skin has a higher sodium content in humans.

The cytokine interleukin-17A (IL-17A) is a crucial player in the pathogenesis of the autoimmune disease of psoriasis. This neutrophil recruiting cytokine is produced by IL-17A producing CD4+ T cells (Th17) and gamma/delta T cells of the skin and evokes an inflammation circuit finally leading to the classical clinical picture of psoriasis with hyper- and parakeratosis, erythema, scaling and neutrophil abscess formation.

Besides genetic factors, lifestyle factors are relevant and decide if an autoimmune disease becomes manifest. It was shown previously that increased salt (sodium chloride, NaCl) concentrations boost the induction of murine and human Th17 cells. However, more - and also clinical - studies are needed to understand the correlation between salt content and IL-17A in autoimmune diseases.

This study investigates the hypothesis if skin sodium content in human psoriasis is increased in order to get further insight into the IL-17A-salt-interplay.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-80
* Body mass index (BMI) 18.5- 40 kg/m2
* Glomerular filtration rate \>60 ml/min/1.73m2

Exclusion Criteria:

* Diagnosed or treated hypertension and/or blood pressure above 140/90 at screening
* Palpable peripheral oedema during phyisical examination at screening
* Any type of diabetes mellitus and/or HgbA1c\>6.5% at screening
* Subjects with a thyroid-stimulating hormone \>4.2 mU/L at screening
* Psoriasis patients treated with systemic corticosteroids, chemotherapy agent (methothrexate) or with any kind of biologics/biosimilars
* Subjects with acute disease
* Pregnant or lactating women
* Metal or medical device implant in the body
* Tattoo on the lower extremities
* Subjects with a history of drug or alcohol abuse
* Subjects who are legal incapacitated or their circumstances do not enable the patient to fully understand the nature, significance and scope of this study.
Empiric Treatment for Acute HIV in the ED

An acceptance and feasibility study for immediate ART initiation and storage of laboratory specimens for individuals with suspected acute HIV infection who are diagnosed in one of the 7 participating emergency rooms

Individuals with suspected acute HIV infection willing to start immediate ART treatment will be given the ART regimen (bictegravir 50mg + tenofovir alafenamide 25 mg + emtricitabine 200 mg fixed dose combination) on the day of diagnosis. Those patients beginning immediate ART in the ED who are willing to have additional laboratory specimens drawn in the ED and become part of a cohort to receive ART and have ongoing biological specimens obtained and will be followed for 48 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Suspected acute HIV infection
* agree to start immediate ART and to storage of laboratory specimens

Exclusion Criteria:

* Known chronic HIV infection
* severe renal or liver disease
* drug allergy/hypersensitivity
* prohibited medications
* pregnancy
* co-morbidity that the investigator feels would compromise safety, data interpretation, or achieving study objectives
An Evaluation of the Tolerability and Acceptability of a New Plant-based Formula for Young Children

An evaluation of the tolerability and acceptability of a new plant-based formula in 45 healthy young children

The aim of this study is to evaluate the tolerability and acceptability of a new plant-based formula for young children. The study population consists of 45 healthy children of ≥12 and \<36 months of age

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female children as per the clinical judgement of the Investigator
2. Singleton children
3. Children ≥12 and \<36 months of age at screening
4. Children who have been drinking dairy based beverages or plant-based milk replacements (in combination with breastfeeding or not) for at least 3 weeks prior to screening
5. Children are familiar with drinking ≥400 ml/day of dairy based beverages or plant-based milk replacements,
6. Written informed consent from the parent(s) and/or legal guardian(s) (≥ 18 years of age)

Exclusion Criteria:

1. Children with medical conditions requiring a special diet such as fibre-free diet, food allergy, or food intolerances
2. Children with current or previous illnesses/conditions or interventions which could interfere with the study or its outcome parameters (e.g. diarrhoea requiring treatment, constipation requiring treatment, regurgitation requiring treatment, dental/medical procedures which may impact oral feeding), as per the clinical judgment of the Investigator, within 3 weeks prior to screening
3. Use of medication or nutritional/food supplements known to impact GI tolerance (e.g. anti-regurgitation (including any thickening agent), anti-reflux, anti-diarrheal, laxative medication, systemic antibiotic, probiotic supplements) within 3 weeks prior to screening
4. Children who are using diapers
5. Siblings of participating children
6. Participation in any other study involving investigational or marketed products concomitantly or within 3 weeks prior to screening
7. Children of employees and/or family members or relatives of employees of Danone Nutricia Indonesia or of the participating research institute and local community facilities
8. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol instructions, including daily completion of the diaries by the parents.