cyrilzakka/clinical-trials huggingface dataset:
Implementing PROMs and PREMs in Routine Clinical Care: Assessment of Requirements and Impact

There has been increasing interest in the use of patient-reported outcomes and experience measures (PROMs and PREMs) in clinical practice; yet few empirical studies have been conducted to evaluate the usefulness of such implementation.

Objective: To evaluate the efficacy of the implementation of PROMs and PREMs in routine clinical care for improving health outcomes and satisfaction with health management.

Design: Randomized control trial. Setting: In and outpatient departments of a public hospital in Spain.

Participants: 1,440 adult patients managed for breast cancer, prostate cancer, chronic kidney disease, or bariatric surgery.

Intervention: Patients will monthly complete, through an App from their smartphones, PROMs and PREMs (arm A, n=480), or only PREMs (arm B, n=480). Responses to PROMs will be transformed into a graphic summary, accessible for physicians and patients at the follow-up visits of the project (9 and 18 months after recruitment).

Main outcome measures: Comparison of change among arms on the assessment variables - such as health-related quality of life (EQ-5D-5L), satisfaction with care, or patient-professionals communication. These constructs will be measured at recruitment and at follow up visits for all patients, regardless of their arm allocation (arm C would only be administered these questionnaires, without intervention, n=480).

Expected results: Incorporating PROMs and PREMs in routine clinical care may improve patients\&#39; and health professionals\&#39; experiences on health care, as well as improve patients\&#39; health.


Eligibility Criteria:
Inclusion Criteria:

* Being an active patient of the nephrology service, prostate cancer service, breast cancer service, or bariatric surgery service
* In possession of an email account and having basic knowledge of how to manage emails
* In possession of a smartphone, computer, or tablet with access to the Internet
* Fluent and able to read in Spanish

Exclusion Criteria:

- Under 18 years of age
Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Edema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension

The purpose of this study is to determine whether Non Invasive Ventilation are effective in prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis is that administration of Non Invasive Ventilation during the procedure and systematically in post procedure period is a protective factor against the development and severity of reperfusion pulmonary edema.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years
* First and /or second procedure of pulmonary artery angioplasty
* Mean pulmonary arterial pressure ≥ 40 mmHg and/or pulmonary vascular resistance ≥ 8 WU (Wood unit)
* Patient who signed informed consent
* Patients affiliated to a social security program

Exclusion criteria:

* severe neurological disease: Coma Glasgow Scale \< 8, severe cognitive decline, postural instability, loss of autonomy.
* psychiatric disease (illness)
* sepsis, severe sepsis and septic shock, according to definitions and diagnostic criteria for sepsis of 'Surviving Sepsis Campaign 2012'
* severe respiratory failure defined by a total lung capacity (TLC)\< 50% of the predicted value and/or expiratory volume in 1 second (FEV) \< 30% of predicted value
* obstructive sleep apnea syndrome with Continuous Positive Airway treatment
* preexisting hemorrhagic syndrome or coagulation factors deficiency
* severe renal insufficiency with glomerular filtration rate \< 30 ml/min
* severe hepatic failure with hepatic encephalopathy, hemodynamic disorder, decompensates cirrhosis, metabolic disorder( metabolic acidosis, hypoglycemia) hepatorenal syndrome, coagulation disorder (factor V\< 50%,disseminated intravascular coagulation)
* patient refusal of participation in the study program
* subjects not affiliated to social security program
Effects of MCDG Oil on Postprandial Lipid Metabolism

It is well known that medium chain triglycerides (MCTs) and diacylglycerols (DGs) have effects on lowering circulating triglycerides (TGs). In this study, the mixture of MCTs and DGs (MCDGs) examined whether it has beneficial effects on postprandial lipids metabolism compared to long-chain triglycerides (TGs).

A randomized, double-blinded, controlled, cross-over trial was conducted to verify the effects of MCDGs. Twenty-eight healthy male and female subjects aged 21-29 years with normal body weight \[18.5 kg/m\^2 ≤ body mass index (BMI) \< 25 kg/m\^2\] were recruited. The subjects visited the research site twice over with a seven-day interval after an overnight fast at least 12 hr. On the first visit, the participants were randomly assigned to consume a test or placebo product \[test product: muffins containing MCDG oil (MCDG muffin); placebo product: muffins containing LCT oil (LCT muffin)\] and ingested the assigned product. On the second visit, the participants consumed the other product that they did not eat on the first visit. On both visit day, the 6-hr meal tolerance test was conducted and started at 8:00 in the morning; venous blood samples were collected before (0 hr) and after ingestion (2, 3, 4, and 6 hr) of the products.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with normal body weight (18.5 kg/m\^2 ≤ body mass index (BMI) \< 25 kg/m\^2)

Exclusion Criteria:

* history/presence of hypertension, diabetes mellitus, hyperlipidemia, cardiovascular disease, liver disease, gastrointestinal disease, thyroid disease, or any other acute or chronic diseases requiring treatment
* Use of any medication affecting body weight or energy expenditure for 1 month before screening
Effect of Involving Community-dwelling Older Adults in Activities in Relation to Meals

Community-dwelling older adults receiving support at home such as meals-on-wheels may lose the ability to preserve social, cognitive, and functional abilities, when becoming accustomed to and dependent of community aged care. When still able to cook older adults often hold some control over the foods that are prepared and which they eat, and which helps to foster identity. The purpose of this study is to evaluate community-dwelling older adults being involved in activities in relation to meals in a rehabilitation program.


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling older people (64+ years)
* Able to eat and drink
* Receive meals-on-wheels from the municipality at the time of recruitment
* Live in the city of Odense

Exclusion Criteria:

* Moderate-severe dementia as judged by the home -care staff
* Being deaf and/or not understand the language of Danish.
* Not being able to sign the informed consent
* Receiving (or likely to receive in the next 6 months) enteral tube feeding or parenteral nutrition;
* Participating in other project in the municipality about nutritional support in the form of dietetic advice;
* Or on an end-of-life care pathway
Effects of a Supplement Containing Fucoidan on Basal Body Temperature

We aim to determine whether a supplement containing fucoidan isolated from Mekabu (sporophyll of Undaria pinnatifida), EPA, and DHA has effects of elevating basal body temperature in subjects with low basal body temperature.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women with basal body temperature \< 36.0 ºC
* Healthy as based on medical history and physical examination
* Willing not to donate blood during the study
* Informed consent signed

Exclusion Criteria:

* Renal or hepatic dysfunction
* Heart disease
* Participation in any clinical trial within 90 days of the commencement of the trial
* Subjects who are taking medicines or functional food that may affect basal body temperature
The Role of Angiogenesis-related Pathways in the Development of Port Wine Stains

1. Port wine stain (PWS) is a congenital, progressive vascular malformation of human skin involving the superficial vascular plexus that occurs in estimated 3-5 children per 1,000 live births. In childhood, PWS are flat red macules, but lesions tend to darken progressively to purple and, by middle age, often become raised as a result of the development of vascular nodules. Because most malformations occur on the face, PWS is a clinically significant problem in the majority of patients.
2. The late-stage cobblestoning appearance of PWS subjects is comprised by not only pronounced vascular ectasia with proliferation of thin and/or thick-walled vessels and their stroma, but also numerous epithelial, neural and mesenchymal hamartomatous abnormalities. Despite these histologic observations, the specific mechanisms involved in PWS nodular formation remains unclear.
3. In one nodular PWS subject, we found that phosphatidylinositol 3-kinases (PI3K)/protein kinase B (AKT) and phosphoinositide phospholipase C g subunit (PLC-g) were activated in both hypertrophic areas and nodules within the lesion. These observations led us to hypothesize that the PI3K pathway may play an important role in nodular formation.


Eligibility Criteria:
Inclusion Criteria:

* Age 1 month - 70 years old, male or female;
* The patient and the family of the child agreed to participate in the experiment and signed an informed consent form;
* Clinical diagnosis of refractory port wine stains with thickened nodular or PDL resistance; .There is no bleeding, ulceration, infection, etc. affecting the visual field of laser surgery operation.

Exclusion Criteria:

* Patients with severe infectious diseases;
* Heart disease patients;
* Epilepsy patient;
* Pregnant patient;
* Researchers believe that patients who are not suitable for this experiment
Practical Ultrasonographic Detection of Sarcopenia in Patients With Long-term Gastrectomy

The investigators aimed to evaluate long-term sarcopenia in patients with total and distal gastrectomy by measuring the anterior thigh muscle with USG, which is a more specific and easy method.

Sarcopenia was found to be significantly increased in patients who underwent total, proximal and distal gastrectomy compared to those who did not undergo gastrectomy in the long term.

To date, very few studies have investigated the development of sarcopenia in the long term after gastrectomy. In these studies, sarcopenia was usually assessed using BIA and DEXA. Muscle thickness measured by ultrasound has high sensitivity and specificity in determining regional muscle mass.

Patients who underwent total(n=20) and subtotal gastrectomy(n=35) and patients who did not undergo gastrectomy(n=35) were included in the study.

Ultrasonographic measurements Anterior thigh muscle thickness of the dominant side was measured at the mid-point between the anterior superior iliac spine and the upper border of the patella. Transverse measurements were obtained between the outer fascia of rectus femoris muscle and the periosteum of femur. Sonographic thigh adjustment ratio (STAR) was calculated by dividing the anterior thigh muscle thickness (mm) by BMI.

Functional evaluations Grip strength was measured with an electronic hand dynamometer. Three repeat measurements were performed from the dominant side and the maximum value was taken for the analyses. Chair stand test (CST) was performed while participants were asked to stand up and sit down from a chair - without arm rest, for five times as quick as possible, with their arms crossed over their chests. Three measurements were performed and median values were taken for the analyses.

Diagnosis of sarcopenia The ISarcoPRM algorithm was used whereby the diagnosis of sarcopenia was established if low muscle mass (i.e. STAR values \<1.4 for males and \<1.0 for females) was combined with low grip strength (\<32 kg (males) and \<19 kg (females)) and/or increased CST time (≥12 sec).

Eligibility Criteria:
Inclusion Criteria:

* Who agreed to participate in the study
* Total or subtotal gastrectomy at least 1 year ago
* The control group consisted of patients without gastrectomy with similar exclusion criteria as the patient group

Exclusion Criteria:

* Rheumatic/neurological diseases
* Any organ failure,
* Limitation of mobility
* History of major orthopedic surgery,
* Chemotherapy programs
* Gastric carcinoma recurrence
* Parkinson's disease, previous stroke, cerebellar diseases, multiple sclerosis
* Major depression
* Those who use any assistive device for walking
* People with severe knee, hip and hand osteoarthritis
* Active malignancies (currently or within the last 1 year receiving radiotherapy/chemotherapy
* Severe chronic obstructive pulmonary disease
* Visual impairment and vestibular disorders
* Pregnancy
A Phase I/II Study of KDX-0811(Dexrazoxane) in the Treatment of Accidental Extravasation of Anthracycline Anti-cancer Agents

The purpose of this study is to evaluate the efficacy and safety of KDX-0811(Dexrazoxane) in the treatment of accidental extravasation of anthracycline anti-cancer agents.


Eligibility Criteria:
Inclusion Criteria:

* Patients suspected to have been exposed to extravasation of anthracycline

Exclusion Criteria:

* Patients reasonably suspected to have been exposed to extravasation by other compounds than anthracyclines through the same IV access, e.g. vincristine, mitomycin, and vinorelbine, all of which may cause ulceration
A Phase I/II Study of the Safety and Efficacy of Topical 1-(S)-(3-Hydroxy-2-Phosphonylmethoxypropyl)Cytosine Dihydrate (Cidofovir; HPMPC) in the Treatment of Refractory Mucocutaneous Herpes Simplex Disease in Patients With AIDS

To evaluate the safety and tolerance of topical cidofovir (HPMPC) therapy for refractory mucocutaneous herpes simplex virus disease in AIDS patients. To determine whether topical HPMPC therapy can induce re-epithelialization and healing of refractory mucocutaneous herpes simplex virus disease in AIDS patients. To evaluate the virologic effects of topical HPMPC therapy on herpes simplex virus shedding from refractory lesions.

Patients are randomized to receive topical therapy with placebo (vehicle alone) or HPMPC at either 0.3 or 1.0 percent once daily for 5 days. Patients are assessed to day 15; those with no significant toxicity are eligible to receive open-label topical HPMPC for up to 6 months.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral therapy with AZT, ddI, ddC, or d4T.
* Oral trimethoprim/sulfamethoxazole.
* Dapsone.
* Atovaquone.
* Fluconazole.
* Rifabutin.
* Clarithromycin.

Patients must have:

* HIV seropositivity.
* Mucocutaneous herpes simplex virus (HSV) infection confirmed by previous viral culture and persisting without improvement despite at least 10 days of acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).
* Measurable lesions.
* Consent of parent or guardian if less than 18 years of age.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Active medical problems sufficient to hinder study compliance or assessment of treatment effect.

Concurrent Medication:

Excluded:

* Acyclovir.
* Immunomodulators (such as corticosteroids or interferons).
* Lymphocyte replacement therapy.
* Biologic response modifiers.
* Ganciclovir.
* Foscarnet.
* Vidarabine.
* Topical trifluridine.
* Other investigational drugs (except d4T).
* Amphotericin.
* Intravenous therapy for PCP.
* Chemotherapeutic agents.

Prior Medication:

Excluded within 14 days prior to study entry:

* Immunomodulators (such as corticosteroids or interferons).
* Lymphocyte replacement therapy.
* Biologic response modifiers.
* Ganciclovir.
* Foscarnet.
* Vidarabine.
* Topical trifluridine.
* Other investigational drugs with potential anti-HSV activity.
* Amphotericin.
* Intravenous therapy for PCP.

Excluded within 4 weeks prior to study entry:

* Chemotherapeutic agents.

Required:

* At least 10 days of prior acyclovir at a minimum dose of 1 g/day (oral) or 15 mg/kg/day (intravenous).

Substance abuse.
The Effect of Kombucha on Blood Sugar Levels in Humans

As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans.

Consumption of kombucha, a fermented tea beverage, has been promoted for a wide range of health benefits. However, a systematic literature review (Kapp \& Sumner, 2019) revealed a lack of evidence for human health benefit. Despite the lack of evidence, U.S. retail sales of kombucha and other fermented beverages have increased 37.4% in 2017, and kombucha is the fastest growing product in the functional beverage market.

As a phase 0 clinical trial, we will learn how kombucha influences glucose metabolism in humans. We plan for 20 subjects to take part in this study.

This is a randomized-controlled counter-balanced study design. Subjects will be asked to complete 4 in-person visits over 2 months time (twice per month). At the first visit, subjects will be randomized into one of four groups. At each subsequent visit, subjects will be randomized into one of the remaining groups until they have completed each arm.

Arms (at least 5 subjects in each arm, minimum total=20 subjects)

1. Intervention group 1: commercial kombucha: drink 8oz kombucha
2. Intervention group 2: brewed kombucha: drink 8oz kombucha
3. Control group: drink 8oz tea (the same type as used to brew the kombucha)
4. Control group 2: drink 8oz tap water

Eligibility Criteria:
Inclusion Criteria:

* Men or women ages 30-65 years old
* English-speaking
* Have transportation to campus
* Overweight (BMI \>= 25 kg/m2) or obese (BMI \>=30 kg/m2)

Exclusion Criteria:

* Currently use any type of nicotine product
* A diagnosis of any of the following:

  * Diabetes (type 1 or 2)
  * Cancer
  * COPD
  * Chronic alcoholism
  * Peripheral vascular disease
  * Autoimmune disease
  * Chronic kidney disease
* Pregnant or breastfeeding
* Prescribed medication for insulin, glucose-lowering drugs, or steroids, such as prednisone
* Have routinely taken prebiotic or probiotic supplements in the past 3 months
* Have routinely consumed any of the following more than one time per week in the past month: kombucha, kefir, yogurt, kimchi, cottage cheese, raw apple cider vinegar (with the "mother"), sauerkraut, kvass.
Seating Posture and Its Relation to Pain

A study has been designed to evaluate pain levels experienced by subjects in relation to different sitting postures. The objective is to investigate how various ergonomic sitting positions affect pain intensity, by systematically assessing pain across a range of sitting postures to identify significant differences and correlations.

A study has been designed to evaluate the pain levels experienced by subjects in relation to different sitting postures. The primary objective of this research is to investigate how various ergonomic sitting positions impact the intensity of pain reported by individuals. This will involve systematically assessing pain levels across a range of sitting postures to determine any significant differences and correlations. The findings are expected to provide insights into the relationship between sitting posture and pain, potentially guiding recommendations for ergonomic improvements.

Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 18 and 65, Not having undergone any surgery affecting spinal posture in the last two years

Exclusion Criteria:

* • Psikiyatrik hastalık tanısı olması ya da tedavi alıyor olması Omurganın duruşunun etkilenmesine sebep olabilecek nörolojik, romatizmal, ortopedik hastalık tanısı almış olmak
Patients With Low Cardiac Output Syndrome Undergoing Local Dental Anesthesia

Patients with low cardiac output syndrome requiring surgical and periodontal dental treatment will be selected to undergo the dental procedure using local dental anesthetic: 2% lidocaine with epinephrine and 2% lidocaine without vasoconstrictor. Cardiovascular events and the safety of using two cartridges (3.6 mL) will be evaluated. They will be evaluated by Holter monitoring in the period of 1 hour before, during and 1 hour after the procedure and blood pressure correction will be performed


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced heart failure, in INTERMACS III using dobutamine at 5 to 20 µg/kg/minute due to low cardiac output syndrome
* Presence of periodontal disease, in the 4th or 6th sextant with indication of supragingival and/or subgingival periodontal scaling;
* Residual root or teeth with periodontal disease in the jaw, with simple extraction indicated.

Exclusion Criteria:

* Patients with a ventricular assist device such as an intra-aortic balloon implanted less than 24 hours after the dental procedure or with extracorporeal membrane oxygenation (ECMO);
* Using other inotropes;
* On mechanical ventilation;
* Continuously using a non-invasive ventilation mask;
* In septic shock;
* Presence of acute myocardial infarction \<30 days;
* Patients with terminal non-cardiac disease, cyanotic congenital heart disease or cardiomyopathies with arrhythmogenic potential (arrhythmogenic dysplasia, hypertrophic cardiomyopathy, non-compacted myocardium);
* Pregnant women;
* History of sudden death recovered \< 1 month ago;
* In the recent postoperative period of cardiac surgery (5 days);
* Allergic to sodium bisulfite and methylparaben, preservatives of epinephrine and the anesthetic cartridge, respectively.
Interventions for HIV+ Mothers With Problem Drinking

The purpose of this study is to evaluate the efficacy of a 14-session behavioral intervention for HIV-infected and uninfected mothers with problem drinking. The intervention targets alcohol and drug problems, sexual risk behavior, and parenting. We hypothesize that mothers in the 14-session intervention condition will show improvements in alcohol and drug use, sexual risk behavior, and parenting in comparison to the control condition, which receives a one session brief video intervention.

The purpose of this study is to evaluate the efficacy of a 14-session behavioral intervention for HIV-infected and uninfected mothers with problem drinking. We targeted 118 mothers of adolescent children (aged 11-18). The intervention is based on Social Action Theory (Ewart, 1991) and targets alcohol and drug problems, sexual risk behavior, and parenting. Mothers are followed and interviewed at four intervals over 18 months. Because we anticipate that the intervention will have effects on adolescent behavior, these youth are also enrolled and interviewed at three intervals over 12 months. Adolescents do not attend intervention sessions. We hypothesize that mothers in the 14-session intervention condition will show improvements in alcohol and drug use, sexual risk behavior, and parenting in comparison to the control condition, which receives a one session brief video intervention.

Eligibility Criteria:
Inclusion Criteria for adult participants (mothers):

* Age over 18
* Meets criteria for problem drinking on the AUDIT (score of 6 or greater)
* Has one biological/adopted child aged 11-18 who was in the home at least half the time in the past month

Exclusion Criteria:

* Injection drug use in the past three months
ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.


Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years with planned elective major abdominal, noncardiac thoracic, head and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease with left ventricular dysfunction (systolic ejection fraction \< or = 30%)

Exclusion Criteria:

* Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic instability Cardiac biomarker instability Need for surgical procedure interfering with placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical need for IABP ASA score \> or = 5 Pregnancy Inability to provide informed consent