cyrilzakka/clinical-trials huggingface dataset:
Anti-inflammatory Nutritional Intervention in Patients With Fibromyalgia

This is a randomized clinical trial, aimed to analyse the effects of a potentially anti-inflammatory nutritional intervention in disease assessment parameters, inflammatory markers, and quality of life of Fibromyalgia patients. Patients in the intervention group will adopt an anti-inflammatory diet and a diet with a low ingestion of fermentable oligo-, di- and monosaccharides, and polyols (FODMAPs), for a 3 months period. Group control will adopt a diet based on general recommendations for healthy eating in accordance with the World Health Organization.

The presence of low grade intestinal inflammation has been reported in Fibromyalgia (FM) patients. Other studies associate the persistence of symptoms described in FM to possible alterations of the intestinal microbiota composition, i.e. dysbiosis, with consequent existence of Small Intestinal Bacterial Overgrowth (SIBO). A sample of 100 female patients diagnosed with FM, followed-up at Portuguese Rheumathology Institute in Lisbon, will be distributed randomly in two groups. Group 1 will adopt an anti-inflammatory diet, which is characterized by the exemption of the intake of potentially inflammatory foods, namely gluten, dairy and ultra-processed foods, over a consecutive period of 3 months. During the first month, a low FODMAPs diet will be implemented, along with the anti-inflammatory diet, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2 months, for a total of 3 months of intervention. Group 2 will adopt a diet based on general recommendations for healthy eating in accordance with the World Health Organization. The Ethics Committee of the Portuguese Institute of Rheumathology approved this intervention study.

The results of this study are expected to determine whether a change in patient nutrition helps to alleviate symptoms, which would optimize medical intervention.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FM performed by the physician, according to the Rome III criteria of the American College of Rheumatology, revised in 2010;
* Ability to read and sign the Informed Consent;
* Stable dose therapy within 4 weeks before study start.

Exclusion Criteria:

* Patients with pathologies that prevent the follow-up of the given dietary protocol;
* Patients currently undergoing lactation or pregnancy;
* Prior or current clinical history of abuse of drug or other substances;
* Change of therapy during the intervention period;
* Presence of other inflammatory diseases;
* Uncontrolled medical conditions (eg. Diabetes Mellitus, decompensated heart disease, renal failure, neoplastic diseases, liver diseases).
Study to Assess the Efficacy and Safety of Orismilast in Psoriasis

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe plaque-type psoriasis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe plaque-type psoriasis and assess the safety aspects of these 3 different doses.The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Capable of giving signed informed consent.
2. Male and female patients ≥18 years of age
3. Body weight of \>40 kg
4. Diagnosis of chronic, stable plaque-type psoriasis. If the patient is diagnosed with psoriasis arthritis, the arthritis should be stable.
5. Moderate-to-severe plaque-type psoriasis as defined by Psoriasis Activity and Severity Index (PASI) ≥12, body surface area (BSA) ≥10%, and Investigator Global Assessment (IGA) ≥3.
6. Candidate for systemic antipsoriatic treatment or phototherapy.

Exclusion Criteria:

1. Therapy-resistant psoriasis
2. Unstable psoriasis or psoriatic arthritis with acute deterioration within 4 weeks of the Screening visit.
3. History of allergy or hypersensitivity to any component of the study treatment.
4. Active infection (eg, bacteria, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the Screening visit.
5. Malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinomas.
Protein Intake in Patients With Coronary Heart Disease

Sarcopenia is a skeletal muscle disease, characterised by low muscle strength and muscle mass, and associated with higher medical care costs, shorter life expectancy and physical dependence. Sarcopenia affects around 1 in 10 older adults in the general population. However, in patients with coronary heart disease (CHD), this number is almost 3 in 10. Patients who have CHD are offered cardiac rehabilitation (CR); a multicomponent programme designed to improve long-term health outcomes. Nutritional education is an important part of CR and typically focuses around modifying fat and carbohydrate intake to lower cholesterol levels and achieve a healthy weight. Currently there is little focus on increasing protein intake, which might reduce the risk of sarcopenia. Eligible patients with CHD and low protein intake will receive the standard nutritional education delivered during CR. Next, participants will be randomised to one of two groups: protein education (intervention), or standard information (control). Whilst COVID-19 restrictions are in place, education will be delivered remotely via pre-recorded video. Outcome measures, including protein intake, sit to stand performance, sarcopenia risk score (modified SARC-F), Physical Activity Vital Signs (PAVS) and waist circumference, will be assessed at baseline, at the end of the standard CR programme and after a follow-up period of the same duration as the CR programme.


Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years or older.
* Recent diagnosis of coronary heart disease or a cardiac event related to coronary heart disease.
* Have been offered standard cardiac rehabilitation in a Newcastle upon Tyne Hospitals NHS Foundation Trust.
* Usually receive dietary education as part of their cardiac rehabilitation program.
* Able to understand and undertake the tasks described as part of this study.
* Able to provide written informed consent.

Exclusion Criteria:

* Patients advised against participation in light exercise by a medical professional.
* Patients younger than 50 years.
* Patients unable to alter their diet due to medical reasons; including patients that have been prescribed artificial feeding, texture modified diets, and specialist renal diets.
* Patients with known stage 4 or 5 chronic kidney disease.
* Patients without access to teleconferencing technology or without another adult present (≥18 years; and with capacity to supervise the activity) will be excluded from participating in the remote sit-to-stand test for their safety.
Effect Of Maraviroc On The Pharmacokinetics Of Digoxin

This is an open labelled study to estimate the effect of maraviroc on the pharmacokinetics of digoxin, a probe for p-glycoprotein.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 25.5 kg/m2.
* Total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
* Subjects with an estimated creatinine clearance (CLcr) \<80 ml/min.
* Pregnant or nursing females.
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to the first dose of study medication until completion of study.
Calciphylaxis : Population, Risk Factors, Diagnostic Practice, Therapeutic and Outcome

Calciphylaxis, also called Calcific Uremic Arteriolopathy (CUA) is a lethal affection mostly affecting patient in end stage renal disease. The survival rate is described around 20 to 46% at one year.

Clinical presentation is very painful skin lesions with ulceration mostly located on the trunk or thigh.

Current knowledge about physiopathology, diagnostic practice and therapeutic is very limited.

Actually there is no European study about calciphylaxis and risk factors, diagnostic practice and outcome factors.


Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 18 years with chronic renal failure with Glomerular Filtration Rate \< 30ml/min/1,73m²
* diagnosis of calciphylaxis between 2006 and 2016
* living in the Regions of Bretagne, Pays de la Loire, Poitou-Charentes or Centre Val de Loire.

Exclusion Criteria:

* realized biopsy in favor of differential diagnosis
* significant arterial lesion of lesion area or differential diagnosis more valid
* if the diagnosis is not based on the following criteria: 3 clinical criteria or 2 clinical criteria and biopsy in favor, criteria which are :

  * Patient in chronic hemodialysis or stade 4 chronic kidney disease
  * At least 2 painful sores and hardly curable with concomitant painful purpura
  * Sore and purpura localisation in trunk, extremities and penis.
Effect of Rivaroxaban on Coagulation Parameters- an ex Vivo Study

Rivaroxaban represent a new class of anticoagulation agents. As an oral direct factor Xa inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Xarelto® on different coagulation parameters.

To validate the effects of Rivaroxaban on coagulation parameters plasma samples of patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d are investigated.

Plasma samples are obtained by blood collection before, after 2 hours and after 12 hours after Rivaroxaban dosing in steady state (on 3rd - 5th day).

Several techniques, including clot-based tests, chromogenic assays and ELISA´s are used for coagulation assays in our coagulation laboratory Frankfurt/Main. The influence of Rivaroxaban on different coagulation assays should be investigated in our coagulation laboratory.

Eligibility Criteria:
Inclusion Criteria:

* patients after hip or knee replacement surgery treated with Rivaroxaban 10 mg/d
* must be able to accept blood sampling
NEMO - an App for Side Effect Management in Oncology

This study investigates the use of digital and standardized documentation by patients of frequently occurring adverse events in oncological therapies.

This research study is structured as a Phase I and II clinical trial. In phase I, the feasibility of using a smartphone application to document adverse events that have occurred during oncological therapies by the patient will be investigated. In phase II we will investigate whether the use of the smartphone app allows an improvement of patient care by reducing occurred adverse events.

Eligibility Criteria:
Inclusion Criteria:

* infusional combination therapy with at least two chemotherapy substances with or without further targeted therapies
* combination of at least two immune-checkpoint inhibitors
* able to read and understand German

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded:

* severe neurological disorders
* severe psychiatric disorders
Sub-Cutaneous Insulin in Hyperglycaemic Emergencies

Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay.

This is a randomised trial concerning patients presenting in A \& E with a diabetic emergency, either a Diabetic Ketoacidosis (DKA) or a Hyperosmolar Non-Ketotic Coma (HONC). Once informed consent has been given, each patient will receive standard intravenous treatment. They will also receive a daily sub-cutaneous bolus of either a long-acting insulin or a placebo.

Blood will be taken at regular intervals to analyse the rate of fall of glucose and normalisation of blood pH.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with a diabetic emergency aged 18 and above.

Exclusion Criteria:

* Patients who do not speak English and need a translator.
* Patients under the age of 18 years.
* Patients who are unable to give their consent and who do not have a relative present wiling to give assent.
Possible Effects of Energy Drink Ingestion on Perceived Alcohol Intoxication

The purpose of this study is to determine whether the ingestion of caffeine, Energy Drinks has an effect on perceived alcohol intoxication.

In each of the four study periods, subjects will receive one of the four study treatments in a double blind, randomised, manner. The effects of study treatment on alcohol intoxication will be determined by measurement of breath alcohol concentration and subjective effects of intoxication. Safety and tolerability will be monitored by measurement of vital signs, in particular pulse, and review of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers
* Able and willing to comply with the requirements of the study, confirmed by written informed consent
* Aged 20 to 26 years
* Within acceptable range for weight and body mass index (70-85 kg and 21 to 25 kg/m2)
* At least 12-14 years of formal education
* In good general health as determined by medical history and screening investigations (see below)
* Taking no regular medication
* No history of psychiatric disorders
* Moderate alcohol consumption (less than 190.4 g/week) according to the Daily Drink questionnaire (Collins et a., 1985)
* "sporadic" users of Energy Drinks (fewer than 10 cans of 250 ml in the last 6 months)
* Confirmation that the general practitioner/primary care physician knows no reason that would prevent their participation
* Similar in social and demographic data, similar quality of life
* similar patterns of use of alcoholic beverages and Energy Drinks as well as quality of life (Martinez et al., 2000)
* similar level of physical activity (physical activity questionnaire) (Baecke et al., 1982)

Exclusion Criteria:

* Any condition that the investigator and/or sponsor consider might increase the risk to the volunteer or decrease the chance of obtaining satisfactory data
* Consumed 2\>x\>4 caffeine-containing drinks/day within 3 months of screening
* Smoked \>10 cigarettes/day or equivalent within 3 months of screening
* Consumed more than 190.4 g alcohol per week, or have a history of alcohol or drug abuse or
* Consumed less than one alcoholic drink per week
Investigation of Burnout, Musculoskeletal System and Aerobic Capacity in Nurses

The aim of our study was to evaluate the relationship of aerobic capacity with burnout status, musculoskeletal system, physical performance and exercise benefit/obstacle perception in nurses, who have an important place in the health profession group, and to bring the results to the literature. Demographic information will be obtained from the participants who volunteered to participate in the study. Burnout, musculoskeletal pain and physical performance will be evaluated with relevant scales and aerobic capacity will be measured with a bicycle ergometer.

In the literature, there are studies on the general effects of aerobic exercises on the cardiovascular system, musculoskeletal system, endocrine system, nervous system and psychosocial status. However, despite the benefits of aerobic exercises and the physiological and psychological importance of high aerobic capacity, there are no studies in the literature that examine the factors associated with the aerobic capacity of nurses. These factors affect the professional life of nursesThe aim of our study was to evaluate the relationship of aerobic capacity with burnout status, musculoskeletal system, physical performance and exercise benefit/obstacle perception in nurses, who have an important place in the health profession group, and to bring the results to the literature. Demographic information will be obtained from the participants who volunteered to participate in the study. Burnout, musculoskeletal pain and physical performance will be evaluated with relevant scales and aerobic capacity will be measured with a bicycle ergometer.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* At least 1 year of experience
* Nurses not working in the academic field

Exclusion Criteria:

* Pregnancy
* Malignancy
* Nurses with lower extremity problems
Pharmacy Implementation Trial: Adherence to Antihypertensive Therapy

The purpose of this study is to determine the effectiveness of maximal support of community pharmacies to implement a pharmaceutical care model for establishing and - if necessary - improving adherence to antihypertensive medication in patients with medication-resistant hypertension.

Cardiovascular disease is the main cause of death in large parts of the world. Hypertension is an important risk factor for cardiovascular disease. Although hypertension treatment has improved in the last decade, the effectiveness of antihypertensive therapy still needs attention. Adherence to medication appears to play an important role in that.

Pharmacists can support the general practitioners in their efforts to optimize antihypertensive therapy, by establishing adherence to medication of patients with hypertension in spite of the use of one or more antihypertensive drugs. This is performed with the electronic Medication Event Monitoring System (MEMS®). Registered adherence and accompanying blood pressure are discussed with the patient by the GP.

Implementation of the above-mentioned intervention is studied in two randomized groups of pharmacies. One group receives minimal support in the intervention, the other group also receives interactive educational meetings, reminders and feedback, and support of multiprofessional cooperation.

Eligibility Criteria:
Inclusion Criteria:

* pharmacies: resident in the south of the Netherlands
* patients:

  * 18 years or older
  * diagnosis of hypertension
  * systolic blood pressure between 150 and 180 mm Hg despite the use of antihypertensive drug(s)
  * indication for treatment escalation

Exclusion Criteria:

* patients:

  * impossibility to establish blood pressure properly
  * patient treated by medical specialist
  * change of antihypertensive therapy because of adverse effects of current medication
  * insisting on using dose organisers
  * not managing their drug intake themselves
  * not able to come to the pharmacy
Comparative Effectiveness of Family vs. Individually Focused Diabetes Education and Support

The objective of this study is to compare the effectiveness of a novel program-Family Support for Health Action (FAM-ACT) - to individual patient-focused diabetes self-management education and support (I-DSMES).

FAM-ACT uses three innovative approaches to enhance the impact of family support on diabetes management for adults with diabetes (AWDs):

1. coach family supporters in regular discussions about AWDs' diabetes progress and goals that uses empathetic and autonomy-supportive communication,
2. coach family supporters in practical roles that support diabetes-specific tasks tailored to AWDs' personal goals,
3. leverage family support in the setting of other types of social support for AWDs (support from other AWDs and their family members and Community Health Workers (CHWs))

FAM-ACT will be developed and implemented in culturally-concordant ways, in partnership with the community participating in the program.

Adults with type 2 diabetes and either poor glycemic or blood pressure control will be randomized together with a Support Person (a chosen adult family member or friend) to receive either FAM-ACT or more traditional CHW-led patient-focused I-DSMES over 6 months.

See our published protocol (Deverts et al 2022; full citation in references section) for additional details on the protocol including any changes made after the study started.

Eligibility Criteria:
Patient Inclusion Criteria:

1. Have a diagnosis of Type 2 diabetes
2. Most recent HbA1c done in the 3 months prior to screening phone call \>= 7.5%
3. Plan to use recruiting site for health care over the next 12 months after enrollment
4. Must be able to identify a family member or friend who is willing to be involved in their health care

Patient Exclusion Criteria:

1. Diagnosis (active or prior) of Alzheimer's disease or dementia
2. Preferred language is not English or Spanish
3. Diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder in CHASS EMR Problem list as of screening call date
4. Diagnosis of gestational diabetes without any other diabetes diagnoses
5. Diagnosed with diabetes at age \< 21 years
6. Pregnant or planning to become pregnant in the next 12 months
7. Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
8. Have a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)

Support Person Inclusion Criteria:

1. Able to attend intervention sessions in person or remotely via online video-conferencing
2. At least 21 years old

Support Person Exclusion Criteria:

1. Does not speak English or Spanish
2. Receives pay for caring for the patient
3. Has self-reported serious mental illness (schizophrenia)
4. Has a life-limiting severe illness (e.g. chronic obstructive pulmonary disease requiring oxygen)
5. Has significant cognitive impairment (Alzheimer's disease or dementia)
6. Lives in a nursing home or long-term care facility
7. Concerns that may make it difficult to participate (ongoing health issues, personal events, etc.)
Prediction Model for Response to Biologics and Small Molecular Agent for UC

This prospective observational study is going to develop and validate a prediction model of response to biologic agents and small molecular agents for Korean patients with ulcerative colitis.

In this prospective observational study, patients with confirmed ulcerative colitis, who are going to receive vedolizumab, ustekinumab, or tofacitinib will be enrolled after an informed consent. In the screening period, inclusion/exclusion criteria will be checked and if eligible and consented, demographic data, medical history, disease characteristics and disease activity data will be collected. Before drug administration (week 0), baseline lower GI endoscopy will be performed and colon tissues will be collected. Blood sample and fecal sample will also be collected. After induction therapy with each drug, clinical and endoscopic response will be evaluated at week 14 to week 16 and patients will be classified into responders non-responders. Combing clinical data, blood laboratory data, fecal inflammatory biomarker, genetic data, and colonic transcriptomic data, a prediction model for response to induction therapy will be developed and it will be validated in another patient group. Similarly, based on evaluation at week 52, a prediction model for maintenance response will also be developed and validated.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an established diagnosis of ulcerative colitis based on clinical symptoms, endoscopic features and histopathologic features
* Patients who are going to receive vedolizumab, ustekinumab, or tofacitinib treatment

Exclusion Criteria:

* Not Korean ethnicity by family history
* Inflammatory Bowel Disease Unclassified
* Patients who already received colectomy due to ulcerative colitis
Triglyceride-Glucose Index In Heart Failure Patients In Sohag University Hospital

study the relationship between Triglyceride glucose index and heart failure patients


Eligibility Criteria:
Inclusion Criteria:

* All Heart Failure patients attend to sohag university hospital aged above 18 year old .

Exclusion Criteria:

* Patients on lipid lowering medications
* Patients on antidiabetic drugs
* Patients with comorbidities eg liver cirrhosis or malignancy