cyrilzakka/clinical-trials huggingface dataset:
Pharmaceutical Care and Quality of Life in Conditions Related to Psychotropic Drug Use

This study aims to assess and describe the impact of pharmaceutical care on identified drug-related problems (DRPs) in subjects using psycholeptics and psychoanaleptics in primary care, improving subjects' self-assessed quality of life (QoL)

The hypothesis of the study are:

1. Side-effects are the most common DRPs in subjects using psychotropic medicines in primary care,
2. Treatment effectiveness and safety affect the subjects´ QoL

The study objectives are to:

1. assess QoL in subjects using psycholeptics and psychoanaleptics,
2. analyze identified DRPs and their causes in subjects using psycholeptics and psychoanaleptics
3. evaluate the correlation between the type and total number of DRPs identified in a single subject with QoL,
4. describe the impact of pharmacists´ intervention in the identification and resolution of the DRPs and their causes on subjects´ QoL.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants (years 18+)
* Usage of psycholeptic or psychoanaleptic medicines
* Residence in Istrian County (Croatia)

Exclusion Criteria:

* Minor participants
* Hospitalization during study participation
* Unable to live by themselves
* Unable to participate in study for 3 months
Efficacy of Acupuncture for Shoulder Pain Based on Remote Point Selection According to the Meridians

This double blind randomized controlled trial investigates the immediate efficacy of acupuncture for shoulder pain using remote point selection based on meridian theory. A total of 90 participants with shoulder pain (Numerical Rating Scale ≥ 4) will be randomly assigned in a 1:1:1 ratio to one of three groups: acupuncture SC, acupuncture CS, and rehabilitation. Meridian selection will be determined based on the patient's most painful shoulder movement and corresponding pain location, followed by standardized distal acupoint application. Outcome measures include changes in pain intensity (NRS) and shoulder range of motion assessed at baseline, post-first acupuncture, post-second acupuncture, and 30 minutes post-treatment. Blinded evaluators will conduct all assessments. The study aims to assess the effectiveness of meridian-based remote acupuncture and explore its relationship with shoulder movement patterns and soft tissue involvement.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years old.
* Shoulder pain persisting for at least one week.
* Numerical Rating Scale (NRS) score ≥ 4.

Exclusion Criteria:

* Patients with cervical radiculopathy or other localized neurological disorders affecting the upper limb.
* Psychiatric disorders that may interfere with examination, treatment, or evaluation of disease progression.
* Pregnant patients.
* Inability to provide informed consent.
Fiber Intake & Fecal Bulk Enhanced Response

Some dietary fibres, including wheat fibres, have shown to increase fecal bulk and improve stool. In previous studies, this effect on fecal bulk was especially studied for intact wheat fibers. Moreover, in most studies, the wheat fiber was offered daily as a single dose in cereals. In this study, we investigate whether an increased intake of extracted wheat fiber, implemented at several time points in a normal daily dietary pattern, can also increase fecal bulk and improve stool frequency and consistency. Here we want to demonstrate that an increase in VITACEL Wheat Fiber intake will enhance fecal bulk, both wet and dry weight and that the enhanced wheat fiber intake will also increase stool frequency and consistency. The study is a double-blind crossover design in which the intervention is based on products enriched by VITACEL Wheat Fiber and control products. Both the control and fiber-enriched intervention will last for 10 days with a wash-out period of at least 4 days. The study will be conducted with 25 healthy male human volunteers in the age between 18-70 years old.Persons will be assigned to the intervention groups. In one of the intervention periods participants receive 'control boxes' with products low in wheat fiber and in the other period they will receive boxes with products enriched with VITACEL Wheat Fiber. During an intervention period of 10 days participants will receive 10 boxes, one for each day. In the last 5 days of the intervention + 1 additional day after the intervention (so in total 6 days), participants will collect their fecal samples to analyse fecal bulk. Daily also a diary has to be kept and questionnaires have to be completed to check compliance to the intervention and assess stool consistency, gut-related complaints.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Apparently healthy (no gastrointestinal complaints, no food allergies and no medication that can influence the outcome of this study
* Age range between 18-70 years old
* BMI between 20 and 30 kg/m2
* Average fiber intake of \<23grams per day
* Living in the surrounding area of Wageningen (radius \~20 km)

Exclusion Criteria:

* Any digestive tract disorder that is expected to interfere with this study (e.g. (partial) gastric resection, (hemi)colectomy, Crohn's disease, ulcerative colitis, irritable bowel disease, Coeliac disease)
* Known food allergy (e.g. lactose, gluten, nuts, egg, etc)
* Vegetarians
* Use of pro- or prebiotics
* Use of medication that can interfere with study outcomes (including laxatives, diuretics, antidepressants, codeine or antibiotics)
* Alcohol intake ≥ 40g/day (≥ 3 glasses of beer/wine per day)
* Drug abuse
* Current smokers
* Participation in other clinical trials in the past month
Impact of Undernutrition in Patients Over 70 Years of Age Thrombolysed and/or Thrombectomized for Stroke

Undernutrition is a frequent problem in hospitals (at least 30% of patients, SENECA-NHANES studies). Its impact on morbidity and mortality is well known in gerontology, oncology and intensive care. There are very few neurovascular studies dealing with the consequences of undernutrition present before the stroke. Indeed, most of the medical literature concerns only undernutrition acquired after a stroke. The investigator propose to analyze medical data from a cohort of patients over 70 years of age thrombolysed and/or thrombectomized in the neurovascular department between the years 2014 and 2019.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 70 years of age with cerebral infarction, thrombolysed and/or thrombectomized between 2014 and 2019, managed in the Neurology and Neurovascular Department of the Paris Saint-Joseph Hospital
* French-speaking patient

Exclusion Criteria:

* Patients with non-thrombolyzed stroke
* Patient with a TIA (Transient Ischemic Attack)
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
* Patients who object to the use of their data for this research
Do Self-Report and Physician Impressions of Adherence to Oral Antipsychotic Medication Agree With Objective Data?

The purpose of this study is to prospectively examine adherence to oral atypical antipsychotics in patients with schizophrenia. We are psrticularly interested in examining the level of agreement among self-report, physician impressions and objective measures of adherence. We believe that physicians, casemanagers, and clients significantly overestimate the level of adherence.

Fifty schizophrenia patients will be recruited at the time of their clinic visit to Tri-County MHMR Services and the El Paso Community MHMR Center. Both physicians and patients will be asked to rate the patient's medication adherence on their index clinic visit. Initial ratings will also occur at this visit. After filling their medication prescription, all subjects will be given electronic medication caps that record each time and date their medication container is opened. Patients will then be followed in the community for the next 12 weeks to observe actual adherence to medication from the index visit to the next successive clinic visit. Every two weeks pills will be counted and data will be retrieved from the electronic medication caps. During the first and last two weeks of study, blood will be sampled on two randomly selected occasions approximately 72 hours apart. Self-report and physician assessment of adherence, symptom and attitudinal measures will be obtained a second time at the second clinic visit 12 weeks after the index visit.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia or Schizoaffective disorder
* Between the ages of 18-55
* no documented history of head injury, mental retardation or neurological disorder
Study to Describe the Actual Situation of Hepatitis C Treatment in Brazil

The purpose of the study is to describe: 1) the clinical profile, past and current management of participants with hepatitis C in Brazil reference centers; 2) the current situation about demographics characteristics, liver disease progression and clinical outcomes in Brazilian Hepatitis C virus (HCV) participants naive, in treatment and previously exposed to antiviral treatment without sustained virological response (SVR).

This is an observational, non-interventional, cross-sectional, multicenter study to describe demographic characteristics, treatment performed and clinical outcomes of Brazilian participants with HCV chronic infection in about 12 Brazilian reference centers. It will expect that approximately 2000 participants will be enrolled in the study. Analysis set will consist of participants with HCV chronic infection who are registered at the Brazilian reference centers and meet all the inclusion criteria and have sufficient information to identify the diagnosis of chronic HCV infection with identification of genotype. The study related data will be collected from the medical records in the predesigned electronic Case Report Form (eCRF).

Eligibility Criteria:
Inclusion Criteria:

* Participants with diagnosis confirmed with Hepatitis C infection being followed into the reference centers
* There is no restriction on fibrosis stage or clinical liver disease
* There is no restriction for comorbities or coinfections
* Diagnosis of chronic HCV infection detected by anti-HCV (ELISA assays), HCV Ribonucleic acid (RNA) (polymerase chain reaction \[PCR\] reaction) with identification of genotype

Exclusion Criteria:

* Male or female participant with age greater than or equal to 18 years
* participating in another interventional clinical trial
* Treated participants who achieved sustained Virological Response (SVR)
Choline and Cardiometabolic Health

Trimethylamine-N-oxide (TMAO), a metabolite produced by gut microbial metabolism of dietary choline, has recently been causally linked to atherosclerosis in animal models and has been shown to be predictive of cardiovascular disease (CVD) risk in some but not all cohort studies. The relevance of observations in animals to humans is unclear and little information is available on the mechanisms linking TMAO to increased CVD risk. Vascular dysfunction plays a critical role in the initiation and progression of atherothrombotic disease. Whether TMAO impairs vascular function in humans is not known. The purpose of this study is to determine if short term supplementation of dietary choline, which increases TMAO, affects CVD risk factors, such as glucose homeostasis and vascular function.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-79 years
* Weight stable for previous 6 months (+2.0kg)
* Sedentary to recreationally active (\<30 min aerobic exercise \<2x/wk)
* No plans to gain/lose weight or change physical activity level
* Verbal and written informed consent
* Willing to be randomized to treatment order
* Fully vaccinated against COVID-19

Exclusion Criteria:

* BMI \> 35 kg/m2
* Smoking
* Pregnant or plans of becoming pregnant
* Vegetarian or Vegan
* Changed dietary patterns within the last month
* Diabetes (or use of diabetes medications) or unstable heart disease
* Untreated high blood pressure or high cholesterol
* Health problems that mide it unsafe to participate
* Taking medications, vitamins or supplements that could affect study outcomes (including but not limited to aspirin, antibiotics, prebiotics, and probiotics)
* Known allergy, hypersensitivity, intolerance to choline supplement or its ingredients
* Trimethylaminuria or "fish odor" syndrome
A Clinical Study in Children and Adolescents With Mild to Moderate Atopic Dermatitis

To show therapeutic efficacy of Zarzenda cream compared to Elidel cream in children and adolescents with mild to moderate atopic dermatitis


Eligibility Criteria:
Inclusion Criteria:

* male and female children and adolescents (aged 2 - 17)
* mild to moderate atopic dermatitis
* patients in whom a treatment with topical corticosteroids in not recommended or possible
* wash out periods to be observed

Exclusion Criteria:

* known allergy to one of the two treatments
* known immunodeficiency
* known hepatic or renal insufficiency
* acute skin infections
Diagnostic Accuracy of DIAGNOdent Compared to ICDAS II

There is a paradigm shift in conservative dentistry by substituting the surgical model with the medical model of treatment. Early detection of initial carious lesions will aid in clinical decision making during management ; either no care advised, preventive care advised or operative care advised. According to recent systematic reviews meticulous visual examination using ICDAS II presented a substantial level of reproducibility and accuracy for assessment of carious lesions and was considered the reference for clinical visual assessment . However, visual examination is subjective and is highly dependent on the dentist's skills and experience, with high specificity and low sensitivity. New devices have been developed to detect and quantify incipient demineralization. Besides visual detection systems, laser fluorescence assessment can be considered a suitable method. In vitro data suggested that the visual examination and fluorescence method have similar accuracy to detect initial carious lesions.

This study will be conducted to evaluate the diagnostic accuracy of laser fluorescence device (DIAGNOdent) compared to to visual examination (ICDAS II) in detection of incipient carious lesions for decision making during caries management

Eligibility Criteria:
Inclusion Criteria:

* Non cavitated white spot lesions.
* Patient compliance

Exclusion Criteria:

* Cavitated lesions.
* Medically compromised patients.
* Enrollment in another clinical trials.
The Long-term Study to Evaluate the Safety of Eplerenone in the Treatment of Hypertension in Children Aged 6 to 16 Years

To assess the long-term safety and toleration of eplerenone in the children aged 6 to 16 years with high blood pressure. The study will last at least 1 year and about 140 patients will participate.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 6 to 16 years
* The seated systolic blood pressure greater than or equal to the 95th percentile for age, gender and height, measured on at least 3 separate occasions

Exclusion Criteria:

* K/DOQI classification of stages of chronic kidney disease equal to 4 or 5
* Serum or whole blood potassium \> 5.5. mEq/L
Circadian Misalignment and Insulin Sensitivity

This study will evaluate the effect of circadian misalignment on insulin sensitivity in healthy lean subjects in a randomized cross-over design. Subjects will be admitted to the research facility for two study periods of 3 and 3.5 days. In one of the study periods, the behavioral cycle will be shifted by 12 hours. Insulin sensitivity will be measured with a hyperinsulinemic euglycemic clamp.

Recent evidence shows that misalignment of the circadian rhythm (e.g. by rotating shift work) impairs glucose metabolism markedly, possibly by decreasing insulin sensitivity in peripheral tissues and liver. Nowadays our society is indispensably connected to a lifestyle that allows wakefulness at every time of the 24 hours cycle. Social jetlag is a phenomenon that affects a large part of the general population, thus circadian misalignment extends far beyond those who are on a shift work schedule. Therefore, decreased insulin sensitivity in individuals affected by circadian misalignment may help to explain the increased prevalence of T2DM in night shift workers that has been found in epidemiological studies.

The study is an interventional randomized crossover trial in which each subject serves as it owns control. For the study, the investigators ask the subjects to participate in two study periods, one of 3 days length (control condition) and the other of 3.5 days length (misalignment condition). During the 3.5 day misalignment condition, subjects will shift their day-night rhythm by 12 hours, which will lead to maximal circadian misalignment. Insulin sensitivity will be measured by a hyperinsulinemic euglycemic clamp. Secondary parameters will include ex-vivo skeletal muscle mitochondrial function and whole-body energy metabolism.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* Healthy (as determined by dependent physician based on medical questionnaire)
* Male
* Age: 18-35 years
* Normal BMI (18-25 kg/m2)
* Regular sleeping time (normally 7 - 9h daily)
* Habitual bedtime at 11 PM ± 2 hours

Exclusion Criteria:

* Extreme early bird or extreme night person
* Heavily varying sleep-wake rhythm
* Shiftwork during last 3 months
* Travel across \>1 time zone in the last 3 months
* Engagement in exercise \> 3 hours total per week
* Using \> 400mg caffeine daily
* Smoking
* Unstable body weight (weight gain or loss \> 3kg in the last 3 months)
* Significant food allergies/intolerance (seriously hampering study meals)
* Participation in another biomedical study within 1 month before the first study visit
* Claustrophobia
* Medication use hampering the study (as determined by responsible physician)
* Recent blood donation.
* Any contra-indication to the telemetric pill:
* Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's opinion interfere with the study
The Microbial Impact on Intestinal Fibrosis and the Associated Immune Microenvironment in Crohn's Disease

The goal of this study is to find out if there is a direct connection between an imbalance of gut bacteria and the development of scar tissue in the gut by identifying important bacterial proteins found in scarred gut tissue. Our aim is to identify which types of cells and biological processes are affected by these bacterial proteins in people with Crohn's Disease. We will also study how these bacterial proteins cause changes in 3D models of gut fibrosis.

More than 50% of CD patients develop a penetrating disease or stenosis due to fibrostenosis, which in most cases requires surgery, as no effective therapies have yet been found. The disease leads to both structural and functional alterations of the intestinal mucosa. Although the functional alteration of the mucosa is mainly caused by the continuous tissue damage that occurs during the chronic inflammation associated with CD, recent studies have suggested that the fibrosis associated with CD may be driven by triggering factors independent of inflammation, such as dysbiosis of the microbiota. Our proposal aims to establish the causal link between gut dysbiosis and fibrosis by studying the role of key bacterial proteins present in fibrotic gut tissue.

This project will ultimately offer new molecular targets for the development of possible tailor-made antifibrotic treatments, with likely benefits for healthcare, as it will facilitate the management of severe CD, avoiding surgery and reducing SSN costs.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18 and \<70 years
* Patients able to autonomously sign the informed consent
* Non pregnant or breastfeeding patients
* For CD patients: CD patients with established diagnosis and additionally classified according to 3 stages: B1 (more inflammatory, non-stricturing), B2 (stricturing, non-penetrating) and B3 (stricturing and penetrating). Patients will be stratified on the basis of CT, MRI or ultrasound analysis (stratification already known before surgery)
* For non-IBD patients: patients with other pathologies but not affected by IBD according to the previously reported clinical and endoscopic evaluation criteria (ex. diverticulitis)

Exclusion Criteria:

* Patients \<18 years or \> 70 years
* Pregnant or breastfeeding patients
* For CD Patients: Subjects with CD who do not meet evaluation criteria described above
* For non-IBD patients: Patients undergoing anti-inflammatory and/or immunosuppressive treatments for IBD-related diseases
The Long-term Safety and Effect of Renal Denervation

The goal of this observational study is to learn about the effects of renal denervation in patients with resistant hypertension. The main question it aims to answer is: What are the long term effects of renal denervation on blood pressure and flow within the arteries? Participants will undergo an assessment of their blood pressure, echocardiogram and invasive measurements of blood pressure and flow in the aorta and renal arteries before undergoing the renal denervation procedure. 6 months later these assessments will be repeated.

Renal denervation is emerging as a succesful technique in the treatment of high blood pressure particularly for those people who's disease is resistant to drug therapy. It involves insertion of an catheter through the femoral artery and into the renal artery where it delivers a controlled radiofrequency ablation to the renal artery wall.

The purpose of this ablation is to interupt the sympathetic nervous system which is inappropriately activated in hypertension. Its beneficial effects on BP reduction has been borne out in a recently published randomised clinical trial which demonstrated a reduction in blood pressure in patients who underwent denervation compared to those managed with medication alone and it is now being used worldwide to manage hypertensive patients.

The safety of this procedure has been demonstrated in the peri-operative setting and short term particularly regarding anatomical changes and kidney function. However, its effects have not been demonstrated with invasive imaging or physiological testing in the long term. Therefore, the investigators recognise that a repeat assessment 6 months after denervation using invasive measures (to perform detailed assessments of the effects on aortic, flow and artery stiffness) would be of great benefit in stratifying this technique, which is likely to become widespread in the very near future.

The investigators therefore plan to perform denervation in 20 patients and obtain detailed information on kidney and aortic blood pressure and flow. They will then reassess these parameters after 6 months in the same patients to ensure preservation of pressure, flow and energy transfer and document the effects of denervation on vascular stiffness.

Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure \>160mmHg despite 3 antihypertensive agents
* eGFR \>45

Exclusion Criteria:

* Secondary causes of hypertension
* Prior renal artery intervention
* Renal insufficiency
* Significant stenotic valvular heart disease
* Myocardial infarction, unstable angina or stroke within the preceding 6 months