cyrilzakka/clinical-trials huggingface dataset:
Menthol Popsicle to Manage the Elderly Patient's Thirst in the Immediate Postoperative Period

Thirst is defined as the desire for water seeking and consumption, and is a prevalent symptom in the immediate postoperative period in all age groups. The elderly surgical patient, despite presenting reduced physiological responses to thirst and satiety, in clinical practice, it is observed that they have high thirst intensity. There is evidence that strategies using cold temperatures are effective in quenching thirst of the surgical patient, for this reason, the present study is justified, in order to find strategies that help to reduce thirst in this specific population that is the elderly surgical patient.

The present study aims to: compare the intensity and discomfort of thirst in the use of the menthol popsicle and usual care in elderly patients in the immediate postoperative period. This is a randomized clinical trial, to be performed in a public tertiary hospital. The sample size calculation will be performed after the pilot test is conducted. Two groups will be formed through randomization. The tested intervention consists of the menthol popsicle (experimental group). Thirst intensity (primary outcome) will be measured by means of the Visual Numerical Scale and the discomfort of thirst (secondary outcome) through the Perioperative Thirst Discomfort Scale, in two moments: at the end of the first assesment of the patient and 20 minutes after the intervention. With the results of this study the intend is to offer to the scientific society subsidies on thirst presented by the elderly patients, generating evidence for the improvement of clinical practice. In addition to contributing to the preparation of health professionals in the assertive care of the elderly population, it is estimated to deepen the knowledge about appropriate and innovative interventions to manage the postoperative thirst of the elderly, considered to be this, a representative and growing part of the world population.

Eligibility Criteria:
Inclusion Criteria:

* Elective Surgeries;
* Aged 60 years and over;
* Being fasting;
* Verbalize thirst;
* Have been approved in the assesment of Safety Protocol of Thirst Management (SPTM)

Exclusion Criteria:

* Patients with ingestion and swallowing restrictions;
* Patients with self-reported allergy to mint;
Feasibility and Acceptability of Offering Self-sampling to Non-attendees in Primary Care

The purpose of this study is to determine whether human-papillomavirus (HPV) self-sampling can be used as a primary screening test for unscreened women.

Women residing in the canton of Geneva, aged between 25 and 69 years, who haven't had a Pap test in the last three years, will be invited to participate. Participation to the study will be encouraged through public displays, social networks, and medical consultations. Women meeting the eligibility criteria will be enrolled in the study. They will be randomized into two groups and will receive a home-sent letter, inviting them to either come in for a Pap test or to perform and send back the HPV self-sample that they'll receive at their domicile. Both groups will also receive a questionnaire, in order to better understand the reasons for their previous non-attendance to cervical cancer screening.

Eligibility Criteria:
Inclusion Criteria:

* No previous cervical cancer screening test in the last three years

Exclusion Criteria:

* pregnancy
* previous hysterectomy
BC179 Against Alcohol-Induced Damage

To assess the effectiveness and safety of probiotic strain BC179 in reducing alcohol absorption in the gut, thereby lowering health risks, as measured by participants' hangover scores.


Eligibility Criteria:
* Inclusion Criteria:

  1. A history of long-term heavy alcohol consumption, equivalent to ethanol intake ≥40g/day for over 1 year. The conversion formula is: ethanol (g) = volume of ethanol-containing beverage (mL) × ethanol content (%) × 0.8 (specific gravity of ethanol);
  2. Body Mass Index (BMI) between 18kg/m² and 25kg/m²; Voluntarily signed a written informed consent form, agreeing to participate in this study;
  3. Agreed to comply with the study protocol and restrictions;
  4. Subjects (including male participants) have no plans for conception from 14 days prior to screening until 6 months after the end of the trial and voluntarily agree to use effective contraception.
* Exclusion Criteria:

  1. Patients with various types of viral hepatitis, autoimmune liver disease, drug-induced liver damage, vascular liver disease, genetic metabolic liver disease, or primary liver cancer;
  2. Individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results;
  3. Patients with severe allergies or immune deficiencies;
  4. Pregnant, breastfeeding, or women with plans for pregnancy;
  5. Individuals with severe diseases of vital organs such as cardiovascular, pulmonary, hepatic, renal conditions, or those with diabetes, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system disorders;
  6. Individuals who have used antibiotics within the past two weeks;
  7. Participants who did not comply with the required consumption of the tested product or missed follow-ups, making it impossible to evaluate the effectiveness;
  8. Other participants deemed unsuitable by the researchers.
Vitamin D Supplementation and Neurocognition

This study will evaluate the effect of vitamin D supplementation on the neurocognitive function of older people with lower than normal levels of vitamin D at baseline

Background: Ageing is associated with an increased risk of cognitive decline. Vitamin D plays an important role in many of the symptoms and conditions related to advanced age, including impaired balance, falls and osteoporosis. Vitamin D also has a physiological effect on the function of the central nervous system, and studies have suggested a relationship between this vitamin and changes in cognitive function of older people. The investigators propose a pilot study to evaluate the effect of vitamin D supplementation on the neurocognitive function of older people.

Methods: A total of 30 subjects of both genders older than 65 years with levels of 25-OH Vitamin D lower than 30 ng/ml on routine laboratory screening will be included in the study. Exclusion criteria will include any unstable medical condition as determined by the treating physician, a diagnosis of dementia, the use of supplements containing vitamin D in any dose, significant visual or hearing impairment not corrected by spectacles or hearing aids, and a level of literacy that limits the performance of computerized neurocognitive testing. Following provision of written informed consent for inclusion in the study, subjects will answer a questionnaire providing demographic details, undergo cognitive screening by use of the MoCA test, and computerized cognitive assessment using the Neurotrax battery. All subjects will undergo repeat testing for level of 25-OH Vitamin D, and where below-normal levels are confirmed patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months. Levels of serum calcium will be repeated monthly (end of month 1, 2, 3). At 3 months subjects will undergo repeat testing for level of 25-OH Vitamin D, and repeat computerized cognitive assessment using the Neurotrax battery.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 65 years and older.
* Level of vitamin D (25-OH vitamin D) is less than 30 ng / ml.
* Stable health status as assessed by the treating primary care physician.
* Do not take supplements containing vitamin D.
* Normal cognitive function as determined by MoCA Test screening and clinical assessment
* Adequate literacy to enable the performance of cognitive assessment instruments
* Provide informed consent as required by the Ethics Committee.

Exclusion Criteria:

* Age younger than 65 years
* Health status not stable as determined by the treating primary care physician
* A diagnosis of dementia
* Taking supplements containing Vitamin D
* Significant visual or hearing impairment not corrected by spectacles or hearing aids
* Impaired competency limiting the subject's ability to provide informed consent
What to Eat for Lunch? A Pilot Study to Improve Healthier Eating at Work

This pilot study will test the feasibility and potential effectiveness of a novel approach to improve food choices by employees about what to eat for lunch. The intervention involves the testing of an on-line pre-ordering food program with nutritional information linked to a hospital cafeteria. In this study, the investigators use positive reinforcement of feedback and price discounts during the intervention phase, and then withdraw those components in order to assess the potential for changes to be retained after the study is over.

The study draws on principles from the field of behavioral economics and behavioral change. The investigators test the effectiveness of the intervention with 30 employees (study participants) who are overweight or obese. Based on a recent screening of over 5600 Einstein employees, 66% of those screened were identified as either overweight or obese. There are 3 phases to the trial: baseline (P1), 4 week intervention, (P2) and tapering (intervention without reinforcement) (P3). Participants are randomized to one of two groups (intervention and wait-listed controls).

Our primary hypotheses are that:

1. Participants will purchase lunches with fewer calories during the intervention compared to baseline.
2. Participants will purchases lunches with fewer calories in the tapering phase compared to baseline.

Secondary hypotheses include that, compared with baseline, participants will order lunches with less fat. Changes in participant weight based on self selected goals, and in a measure of mindful eating will also be investigated. The investigators expect that participant adherence will be associated with improved outcomes compared to those who are less adherent.


Eligibility Criteria:
Inclusion Criteria:

* Interested in improving their food choices as it relates to healthier eating and weight loss
* Adult employee at large, urban hospital in Philadelphia at which study is being conducted
* Eats at least 4 lunch meals a week at study cafeteria
* BMI greater than or equal to 25.0 (based on standard classification).
* Willingness to allow researchers to collect data about their lunch purchases
* Willingness to "swipe" their employee card for lunch purchases during the study
* Access to a computer at work
* Capable of providing informed consent
* Has a way of being contacted by telephone, email, fax, or receiving a text message

Exclusion Criteria:

* Planning to terminate hospital employment within the next 4 months
* Individuals unable to consent
* Individuals who are not yet adults
* Employees who are pregnant
* Employees with hypertension, dyslipidemia or coronary artery disease whose medical therapy has changed in the past 3 months.
4-week Seaweed Supplementation on Menopause Symptoms and Psychological Wellbeing

Menopausal symptoms have a substantial effect on quality of life as well as potentially serving as markers for future health. Previous research has suggested that diet can impact menopausal symptoms. Seaweed is marketed as a treatment to alleviate menopause symptoms, but no research has tested whether it is effective in reducing the symptoms and psychological effects associated with menopause.

The aim of this study is to investigate the effects of consuming a seaweed supplement over a 4-week time period on menopausal symptoms and psychological well-being.

Menopause and peri-menopause are associated with a number of symptoms and psychological well-being. Previous literature has found a relationship between diet and menopause management. For example, following the Mediterranean diet consuming a variety of vegetables, fruits, legumes and whole grains has found to improve menopausal symptoms particularly vasomotor symptoms. Few studies have explored the effects of dietary supplements on psychological well-being in menopause. The aim of the study is to explore the impact of an iodine-rich seaweed food supplement on menopause symptoms and mental well-being in those experiencing menopause. Online assessments of symptoms will take place pre-intervention and post-intervention and will be compared to the effects of a placebo.

Eligibility Criteria:
Inclusion Criteria:

* Self-assess as healthy
* Experienced menopausal or peri-menopausal symptoms in the past 6 months

Exclusion Criteria:

* Are currently taking HRT, anti-depressants, or anti-anxiety medication
* Are lactating or pregnant (or seeking to become pregnant)
* Have a thyroid disorder
* Are currently taking iodine supplements
* Have any relevant food intolerances
Pilot Study on Auricular Vagus Nerve Stimulation Effects in Chronic Diabetic Wounds

The purpose of this pilot study is to evaluate the effect of auricular autonomous nervous system stimulation on vital parameters of wound healing in diabetics. It is investigated if auricular vagal nerve stimulation has an effect on heart rate variability as well as peripheral local blood perfusion, and if this effect depends on the health status of the study participants (diseased/healthy).


Eligibility Criteria:
Inclusion Criteria:

* diabetes mellitus type 2
* ulcus cruris (plantar)
* min. 6 weeks of standard wound therapy without success
* intact big toe on wound side

Exclusion Criteria:

* participation in a clinical trial in the last 5 weeks
* confounding medical treatment, e.g. prostaglandin
* vascular diseases other than peripheral arterial occlusive disease
* diseases which may affect the autonomous nervous system or wound healing, except diabetic concomitant diseases (e.g., polyneuropathy, angiopathy)
* drug abuse
* active implanted devices
* pregnancy or nursing
A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants

The purpose of this study is to assess whether taking lasmiditan and sumatriptan together will have any additional effects on heart rate and blood pressure compared to taking lasmiditan and sumatriptan individually. This study will also look at the amount of study drug that gets into the blood stream and how long it takes the body to get rid of it when these two drugs are taken together.

This study will last about 21 days, not including the screening. Participants will spend 16 days/15 nights in the clinical research unit (CRU) followed by follow-up. Screening is required within 28 days prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males or females, as determined by medical history and physical examination
* Have a body mass index of 19.0 to 35.0 kilograms per meter squared (kg/m²) inclusive

Exclusion Criteria:

* Have known allergies to Lasmiditan, Sumatriptan, related compounds, or any components of the formulations of Lasmiditan and Sumatriptan
* Have a history of, or electrocardiogram (ECG) findings of, clinically significant bradycardia, heart block, tachy or brady arrhythmias
* Have a history, signs, or symptoms of arrhythmia or Wolff Parkinson White syndrome that could affect the participant's safety
* Have an estimated glomerular filtration rate (eGFR) of less than (\<) 60 milliliter per minute (mL/min) per 1.73 m²
* Have a resting systolic blood pressure (SBP) greater than (\>) 135 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) \>85 mmHg at screening
* Have a supine pulse rate (PR) of \<50 or \>90 beats per minute (bpm) at screening
* Have a history, signs, or symptoms of vasospastic coronary artery disease
* Have known or ongoing neuropsychiatric disorders (for example, manic depressive illness, schizophrenia, depression) considered as clinically significant by the investigator
* Use of monoamine oxidase-A inhibitors and other drugs associated with serotonin within the 3 months prior to the first dosing occasion
Hemodynamic Effects of Cold Versus Warm Fluid Bolus

Fluid boluses are often administered with the aim of improving tissue perfusion in critically ill patients. It is unclear whether the temperature of the fluid has an impact on the hemodynamic response. The aim of this study is to describe the hemodynamic effects of a fluid bolus with two different temperatures.

A randomized, controlled, cross-over study in 21 healthy volunteers. The participants will receive a fluid bolus of 500 ml Ringer's Acetate at either 22°C or 38°C over 15 minutes in a randomized order. Non-invasive measures will be made of cardiac index, mean arterial pressure, systolic blood pressure, diastolic blood pressure, heart and pulse rate, saturation and temperature. Hemodynamic measure will be made using the Clearsight® system. Measurements will be made during 120 minutes. The second session will take place at least one day later, and the participant will then receive the other fluid temperature.

Eligibility Criteria:
Inclusion Criteria:

- Volunteers 18 years or older Previously healthy

Exclusion Criteria:

* American Society of Anesthesiologists classification 2 or above.
* Known pregnancy
A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy

Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing. The most valuable data for assessments of this type comes from adhesion and wear time studies involving application to living human skin on volunteers. The purpose of the study is to assess the safety and performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a group of subjects with an ileostomy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who provide written informed consent.
* Subjects who have an ileostomy and be over 18 years of age.
* Subjects who are currently using a one piece drainable pouch.
* Subjects who have unbroken peri-stomal skin (healthy normal skin defined as "normal unbroken skin with certain variations normal for this subject" to L1 on the SACs Instrument Scale).
* Subjects with a stoma considered 'normal' in appearance in accordance with the stoma, colour, moisture and structure rating scales.
* Subjects who are willing to attend clinic for a maximum of 5 separate occasions for scheduled visits.
* Subjects who are willing to discontinue the use of pastes, adhesive strips and rings/seals used to seal the area between the skin barrier wafer and stoma during the use of the study device.
* Subjects who other than their ileostomy considered to have a healthy/stable health status.
* Subjects who have good manual dexterity and be able to take care of their stoma independently, or have a consistent care provider.
* Subjects who are willing and able to complete a diary card for the duration of the study.

Exclusion Criteria:

* Subjects with a history of sensitivity to any one of the ostomy products or the components being studied.
* Subjects with stoma duration of less than 3 months.
* Subjects who currently use a belt with their usual appliance.
* Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
* Subjects who require convexity or other skin fillers (pastes, rings, seals) to even undulations of the skin.
* Subjects undergoing chemotherapy or radiotherapy.
* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study.
The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality

The association between weight, and cardiovascular disease and mortality is well established, however, the causal effect of weight-loss in midlife on these outcomes is less clear. Bariatric surgery results in substantial weight-loss and is an ideal candidate to study the causal effects of weight-loss. The investigators propose a project that will use causal inference and machine learning methods to answer two important questions:

1. Is bariatric surgery effective for reducing cardiovascular disease and mortality, and if so, for who?
2. Which type of bariatric surgery (gastric bypass or sleeve gastrectomy) is most effective, and for who? The investigators will use data from various Swedish registers to identify individuals with obesity who are eligible for bariatric surgery. We will then compare cardiovascular and mortality outcomes among those undergoing different types of bariatric surgery with those receiving non-surgical obesity management using causal inference methods. The investigators will use causal forests and expert knowledge to estimate indiviual treatment effects, and identify the groups of patients who benefit the most from these surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of reproductive age with a diagnosis of obesity, no prior history of cardiovascular disease or cancer, and no contraindications for surgery after 1982

Exclusion Criteria:

* Contraindications to bariatric surgery
SafeTy and Outcome of contemPorary Treatment Strategies for Cardiogenic SHOCK

International, observational registry to investigate the outcome in patients with cardiogenic shock. The primary aim of this study is to investigate the clinical outcome of patients in cardiogenic shock.

There is a focus on interventional therapies, mechanical circulatory support and new cardiovascular therapeutics in patients with cardiogenic shock (CS). The investigators will describe current practice in study sites including concomitant patients with CS. Therefore, the investigators will monitor drug therapies initiated, devices being utilized as well as outcome and side effect of possible interventions

Eligibility Criteria:
Inclusion Criteria:

* Patients with cardiogenic shock treated at a tertiary care hospital.

Exclusion Criteria:

* Age ≤17 years.
Risedronate In The Prevention Of Osteoporosis In Osteopenic Postmenopausal Women

To confirm the superiority of 5 mg daily risedronate as compared to placebo in maintaining or increasing bone mass in lumbar spine in osteopenic postmenopausal women

To confirm the efficacy of 5 mg daily risedronate in osteopenic postmenopausal women in maintaining or increasing bone mass in proximal femur and decreasing bone resorption

To confirm general safety of 5 mg daily risedronate as compared to placebo


Eligibility Criteria:
Inclusion Criteria:

* Ambulatory, healthy postmenopausal women with

  * Natural menopause and more than 5 years after their last menstrual period
  * or surgical menopause and more than 5 years after surgery
  * osteopenia (lumbar spine T score between 1 and 2.5 SD below the mean value in normal young women).
* With at least one risk factor for osteoporosis

Exclusion Criteria:

* Women who have received hormone replacement therapy (with estrogen and/or progestogen and/or androgen) or raloxifene within 3 months before visit 2 or calcitonin or calcitriol within 4 weeks before visit 2