cyrilzakka/clinical-trials huggingface dataset:
Teaching: Individual to Increase Adherence to Therapeutic Regimen in Hypertension Arterial and/or Diabetes Type 2

The purpose of this study is to improve the adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2. Our hypothesis is the nursing intervention "Teaching: Individual", is more effective to increase adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2, than usual care.

Introduction: The hypertension arterial and diabetes mellitus are chronic diseases with a high burden of disease. It affects approximately 25% of the adult population worldwide and is an important risk factors for global mortality. As for the diabetes, worldwide there are about 346 million people with diabetes and 80% of them live in countries with low and middle income. The recommendations for treating of these diseases includes the pharmacological treatment and modification of lifestyle: salt restriction, moderation in alcohol consumption, high consumption of fruits and vegetables, low-fat diet, weight reduction and regular physical activity. The adherence to these guidelines are essential keys to success in handling these pathologies. The lack of adherence to the prescribed treatment regimen remains a problem among patients with long-term treatment.

Objective: To evaluated the efficacy of nursing intervention "Teaching: Individual" compared with usual care, to increase adherence of therapeutic regimen in people with hypertension arterial and/or diabetes mellitus type 2.

Methods: Randomized controlled trial. 200 patients with hypertension arterial and/or diabetes mellitus type 2 attending cardiovascular risk programs of Bucaramanga, Colombia will include . Nursing intervention to evaluate is "Teaching: Individual" consisting in six educational sessions. The investigators will measure 0, 6 y 12 months: Treatment Behavior: Illness or Injury (1609) (adherence treatment), glycosylated hemoglobin (HbA1c) and systolic blood pressure for 24 hours. Base characteristics of the groups will be compare through chi-square/Fisher´s exact or Students-T/Mann-Whitney U test. Outcomes will be evaluate by paired T-tests or Wilcoxon test at different follow-up times and statistical significance with p-value \< 0.05 will considered.

Eligibility Criteria:
Inclusion Criteria:

* Adult population ≥ 18 years old
* Medical diagnosis of hypertension arterial and/or diabetes mellitus type 2.
* Attendees cardiovascular risk programs of Empresa Social del Estado Instituto de Salud de Bucaramanga (ISABU)
* People totally independent of their care.
* Access to a fixed telephone line or mobile itself
* Be residents of Bucaramanga

Exclusion Criteria:

* Changes in the mental sphere. Abbreviated Mental Test (Minimental) and Yesavage depression test.
* Communication limitations or chronic or serious alterations that make it hard compression of interventions.
* Subjects who are participating in a research study currently or during the last six months.
A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).


Eligibility Criteria:
Inclusion Criteria:

* Caucasian origin
* Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive
* Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)

Exclusion Criteria:

* Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®)
* Previous participation in this trial, defined as randomised to receive trial product
* Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator
* Known history of atherosclerosis or thromboembolic events
* Overt bleeding, including from gastrointestinal tract
* Hepatitis B or C infection
* HIV infection
* Positive test for drugs of abuse
The Role of Therapy for Muscle Tension Dysphagia

Muscle tension dysphagia is a novel diagnostic taxonomy describing a subset of patient population with reported dysphagia who exhibit normal oropharyngeal and esophageal swallowing function as evidenced by videofluoroscopic swallow study. These patients also demonstrate abnormal supraglottic muscle tension during laryngoscopy as well as signs of laryngeal hypersensitivity and laryngopharyngeal reflux. Treatment of these patients with Proton Pump Inhibitor (PPI) therapy is a common practice however voice therapy invention targeting the unloading of the supraglottic muscle tension has been shown to be highly effective in symptom resolution per the investigators' clinical experience. The study is designed to answer efficacy of treatment being offered to patients with muscle tension dysphagia.


Eligibility Criteria:
Inclusion Criteria

* Age 18-99
* Diagnosed with Muscle Tension Dysphagia

Exclusion Criteria

* Physical or emotional disorder preventing the completion of therapy
Effectiveness and Safety of Semaglutide Combined With Dietary Fiber (Soloways) in Adults With Overweight or Obesity

This clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active fiber supplements and the other with Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing Semaglutide's efficacy.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥30, or ≥27 with comorbidities.

Exclusion Criteria:

* Serious chronic illnesses.
* History of bulimia or anorexia.
* Pregnancy or lactation.
Role of Nitric Oxide in Optic Nerve Head Blood Flow Regulation During Isometric Exercise in Healthy Humans

Autoregulation is defined as the ability of a vascular bed to adapt its vascular resistance to changes in perfusion pressure. In the eye, several studies have reported that retinal blood flow is autoregulated over a wide range of ocular perfusion pressures. The investigators recently showed that nitric oxide (NO) is a key metabolite in the regulation of vascular tone in the eye and plays an important role in the blood flow autoregulation of the choroidal circulation. However, no data is yet available for the optic nerve head. Thus, the present study is designed to test the hypothesis that NO plays also a role in optic nerve head blood flow autoregulation. Therefore, subjects will perform squatting to increase systemic perfusion pressure during administration of either a nitric oxide synthase inhibitor (L-NMMA), an α-receptor agonist (phenylephrine) or placebo. Optic nerve head blood flow will be continuously measured during the procedure to investigate optic nerve head autoregulation.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years, nonsmokers
* Men and women will be included in equal parts
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
* Normal findings in the laboratory testings unless the investigator considers an abnormality to be clinically irrelevant
* Normal ophthalmic findings, ametropia less than 3 diopters

Exclusion Criteria:

* Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Treatment in the previous 3 weeks with any drug (except intake of oral contraceptives)
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of study drugs
* Blood donation during the previous 3 weeks
* Pregnancy
Iron Absorption and Transfer to the Fetus During Pregnancy in Normal Weight and Overweight/Obese Women and the Effects on Infants Iron Status

Overweight and obesity causes low-grade systemic inflammation, which sharply increases risk for iron deficiency. Studies in our laboratory have shown that this is mainly the result of reduced dietary iron absorption because of increased hepcidin concentrations. During pregnancy, women have a large increase in iron needs because of the expansion of maternal blood volume and fetal needs. Iron deficiency anemia in infancy can impair cognitive development. Whether maternal adiposity impairs absorption and transfer of iron to the fetus, and thereby increases risk of iron deficiency in the mother and the infant is unclear.

In obese subjects, hepcidin concentrations are increased and iron absorption is believed to be reduced, leading to iron deficiency over time. How all this will influence iron supply of the fetus in obese pregnancy has not been well investigated to date. Even if maternal and fetal iron uptakes are regulated separately, it is unclear to what extent maternal subclinical inflammation might influence this process. A small study by Dao et al. indicated that maternal-fetal iron transfer was impaired in obese pregnant women, possibly due to hepcidin up-regulation. In this study, both maternal BMI as well as hepcidin were negatively correlated with cord blood iron status. Maternal hepcidin and c-reactive protein were significantly higher and cord blood iron was significantly lower in the obese compared to the normal weight. Hepcidin was shown to have an effect on iron transfer across the placenta in the study by Young et al.: the transfer was increased in women with undetectable hepcidin at delivery compared to those with higher levels. As of now, clear associations between maternal BMI or maternal hepcidin concentration and fetal iron status were not shown.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with either normal pre-pregnancy BMI (BMI 18.5 - 24.9kg/kg2) or with overweight or obesity (BMI \> 27.5kg/m2) before pregnancy (assessed based on data reported by the women at their first visit at the hospital)
* 18 to 45 years old
* singleton pregnancy
* week of pregnancy 14±3

Exclusion Criteria:

* underlying malabsorption disease
* chronic illness, which influences iron absorption
* inflammatory status other than obesity
* medical problems known to affect iron homeostasis
* smoking during pregnancy
* no regular use of medication, which influences iron absorption
Free Fatty Acids and Vascular Function in Subjects With Diabetes

This study will test the hypothesis that reduction in release of free fatty acids from adipocytes will restore insulin-mediated endothelium-dependent vasodilation and skeletal muscle glucose metabolism in subject with type 2 diabetes.

During the past two decades, there has been a steady increase in the incidence of diabetes mellitus, such that nearly 17 million people are now afflicted. The vast majority of these have type 2 diabetes. Over the next 40 years, the type 2 diabetic population in the United States is expected to increase to nearly 30 million.

Diabetes substantially increases the risk of atherosclerosis, and thereby, cardiovascular morbidity and mortality. Indeed, cardiovascular disease causes more than 50% of the mortality in patients with diabetes. People with type 2 diabetes manifest two cardinal signs of dysmetabolism: hyperglycemia and insulin resistance. Insulin resistance is a progressive phenomenon that occurs well before the onset of frank diabetes, and results in alterations in insulin signaling. Experimental studies suggest that insulin signaling is required for vascular homeostasis, and its impairment is associated with endothelial dysfunction. In the clinical setting, insulin resistance is associated with atherosclerosis and predicts cardiovascular events independent of hyperglycemia. Therefore, we will study the importance of insulin signaling in endothelial biology in humans and the effects of free fatty acids on endothelial function in people with type 2 diabetes.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus (as defined by the National Diabetes Data Group)
* normal cardiovascular exam
* non smoker (for 1 year prior to entry)
* Healthy volunteers
* no known medical problems
* normal cardiovascular exam
* fasting glucose \< 110 mg/dL
* non-smoker (for 1 year prior to entry)

Exclusion Criteria:

Type 2 Diabetics

* untreated hypertension (\>140/90 mmHg)
* untreated hypercholesterolemia (LDL \> 75th percentile for age)
* cigarette smoking within 1 year
* neuropathy requiring medication
* nephropathy (\> 300mg/24 hour urinary albumin, or serum creatinine \> 1.4 mg/dL
* abnormal cardiovascular exam
* treatment with thiazolidinedione within 1 year
* post-menopausal women taking hormone replacement therapy

(Note: subjects taking angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) must stop these medications for 2 weeks prior to taking study drug. If blood pressure rises to \>140/90, subjects will be prescribed an alternative medication or be withdrawn from the study.

Healthy Volunteers

* abnormal cardiovascular exam
* use of prescription medications
* fasting glucose \> 110mg/dL
* cigarette smoking within 1 year
Dual-task Exercise in People With Cognitive Impairment

The purpose of this study is to explore how performing two exercise-based tasks simultaneously (dual-task exercise) affects the neurovascular and cognitive responses of people with cognitive impairment, which is a growing concern globally. Specifically, the study will examine how motor-cognitive dual-task exercises, such as using elastic resistance bands combined with visual perception training, including eye movement exercises, can immediately improve outcomes such as Brain-derived neurotrophic factor (BDNF) levels, cerebral blood flow, cognitive function, and mobility. BDNF is a special chemical in our brain that helps with the connections between brain cells. Participants will be asked to complete a single 30-minute exercise session and undergo assessments before and after the intervention. Participants with cognitive impairment will be initially assessed using Mini-Mental State Examination (MMSE) which is a 30-point questionnaire used extensively in clinical and research settings to measure cognitive impairment. Any score of 24 or more (out of 30) indicates normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points), or mild (19-23 points) cognitive impairment. Participants with lower MMSE scores (\&lt;10) will be removed from the study.


Eligibility Criteria:
Inclusion Criteria:

* Age \&gt;65 (PwD or cognitively impaired older adults) (ICD-10)
* People with and without cognitive impairment (MMSE score 13-30)
* Subjects must be able to exercise at a moderate intensity level (see exclusion criteria)
* Subject must be willing and able to provide a blood sample

Exclusion Criteria:

* • Subjects with other neurological disease (stroke, Parkinson's, or multiple sclerosis)

  * Significant current orthopaedic (fractures, hemiplegia, pain, arthritis etc.), cardiovascular and pulmonary conditions (arrhythmias, uncontrolled hypertension, acute bronchitis, cardiac insufficiency etc.) that would limit the ability to perform cardio-respiratory fitness assessment, tasks or exercise
  * Psychiatric conditions (depression, anxiety disorder, etc.) and a history of severe psychiatric disorders (schizoaffective/bipolar disorders, or schizophrenia)
  * Severe vision/hearing impairments that cannot be corrected with aids
  * Unable to comprehend questionnaire material study procedures
Phase I Study to Evaluate Bioavailability of Overencapsulated Celecoxib

Phase I study designed to test the hypothesis that overencapsulated celecoxib 200 mg qd is bioequivalent to commercial celecoxib 200 mg qd. Approximately 90 healthy volunteers will be randomized to yield approximately 80 completers. The study is an open label, randomized, 2-way crossover with single dosing followed by a 7-day washout period between treatment arms


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects 18-55 yrs. of age (inclusive) at Screening Visit
* Body Mass Index (BMI) of greater than or equal to 19 to less than or equal to 30 kg/m2 and weight of greater than or equal to 50 to less than or equal to 100 kg
* Clinically normal physical exams and laboratory measurements

Exclusion Criteria:

* Subject has received another investigational drug within 4 weeks preceeding this study or planning to participate in another study at any time during the period of this study
* Any significant medical or psychiatric condition that could affect the interpretation of the PK data, or which otherwise would contraindicate participation in a clinical trial
* Any GI disease, abnormality or gastric surgery that may interfere with gastric emptying, motility and drug absorption
* Subject who has donated a unit of blood or plasma within 3 months prior to the Screening Visit
AdHerencE to Treatment and quAlity of Life in COPD

The present non-interventional observational study in the Greek population aims at collecting the characteristics of COPD patients selected to be given the inhaled combination of fluticasone propionate and salmeterol in doses of 100 μg mcg (250 μg) mcg (500 g) mcg through the Elpenhaler® device, to investigate (a) the effectiveness of the treatment for compliance and the quality of life of the patients; and (b) the safety of the drugs in patients whose disease is treated either in a hospital or in a private physician.

Rolenium® is an inhalable combination the active ingredients of which is the inhaled combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg, (500 + 50) mcg administered via the Elpenhaler ®, developed by ELPEN. It has been approved as a bronchodilator therapy for COPD (a fast-exiting volume in the first second (FEV1) after a bronchodilator less than 60% predicted) with a history of repeated seizures that have significant symptoms despite regular bronchodilator therapy. For COPD in adults an inhalation of 500 micrograms of fluticasone propionate and 50 micrograms of salmeterol twice daily is recommended4. More information on the efficacy and safety of the investigational medicinal product is provided in the Summary of Product Characteristics (SPC).

Eligibility Criteria:
Inclusion Criteria:

* Patients to be started on Rolenium®, an inhaled combination of fluticasone propionate and salmeterol in doses (100 + 50) mcg, (250 + 50) mcg, (500 + 50) mcg administered via the Elpenhaler®
* Patients who should be diagnosed with severe COPD and FEV1 \<60% of the expected normal rate and a history of repeated exacerbations that have significant symptoms despite regular bronchodilator therapy:

  1. Single LABA bronchoconstriction
  2. Under dual bronchoconstriction LABA / LAMA
  3. Never have received inhaled or systemic corticosteroids (ICS)
  4. Previous ICS use in the past may be present, as long as the patient is not in the same treatment for the last three months.
* Male or female patients over 18 years of age
* Compliance with treatment
* Compliance with study procedures
* Signed informed consent form

Exclusion Criteria:

* Men or women under 18 years of age
* Non-compliance with treatment
* Inappropriate use of inhaled therapies
* Non-compliance in study procedures
* Unsigned patient consent
O-ARM Stereotactic Imaging in Deep Brain Stimulation for Parkinson's Disease

During deep brain stimulation procedures in Parkinson's disease (PD), the most important prognostic element is the positioning of the surgical electrode in the subthalamic nucleus which is the anatomical target. The main objective of this project is therefore to compare 2 techniques thanks to a prospective comparative randomised open-label study: the use of O-ARM to acquire stereotactic imaging directly in the operating room and the standard technique requiring stereotactic imaging to be performed in the radiology department.

Prior to electrode implantation we perform stereotactic imaging which requires the fixation of a stereotactic frame on the patient's head before imaging (Magnetic Resonance Imaging MRI / Computed Tomography CT). Currently, it is necessary to transfer the patient to the imaging department outside of the operating room after the stereotactic frame has been placed, for imaging (either MRI or CT) and then to return to the operating room to begin the electrode implantation procedure. Since 2016, the new generation O-Arm 2 allows the acquisition of stereotactic imaging with the stereotactic frame in place by increasing the field of view (40 cm versus 20 cm previously) directly in the operating room. As a result, the transfer step to the MRI and CT scanner preoperatively may no longer be necessary, and the procedure can be started more quickly with greater comfort and safety for the patient and the anaesthesia team. Several teams around the world have begun to use framed O-Arm as the gold standard for stereotactic imaging. However, no randomised controlled study has been performed to date comparing O-Arm stereotactic imaging with pre-operative CT and/or MRI reference imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of idiopathic Parkinson's disease at the stage of motor fluctuations despite optimal medical treatment
* Indication for Deep Brain Stimulation (DBS) of the subthalamic nucleus approved by the local multidisciplinary deep brain stimulation committee after an operability assessment (see Appendix)
* Informed and signed patient consent
* Affiliation to a social security scheme

Exclusion Criteria:

* Significant cognitive decline assessed in a dedicated multidisciplinary consultation
* Contraindication to Magnetic Resonance Imaging (MRI)
* Presence of pathologies contraindicating deep brain stimulation
* No contraceptive treatment for women of childbearing age
* Pregnant or breastfeeding woman
* Anticoagulant or antiaggregant treatment that cannot be stopped
* Persons under legal protection (persons deprived of liberty or incapable of giving consent or under guardianship or tutelage...)
* Patient with severe psychiatric disorders
Quality of Life Related to Health in Spa Users

Hypothesis: The spa therapy treatment could improve health-related quality of life (HRQOL) in subjects with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis.

Main objective: Analyze if HRQOL in patients with knee and/or hip osteoarthritis, and patients with rheumatoid arthritis is modified by spa therapy treatment in the spa of Fitero (Spain).

Design: Prospective observational study Participants: Fitero's spa users aged between 45-80 years old, diagnosed with knee and/or hip osteoarthritis, and also with rheumatoid arthritis. At least 40 patients of each type will be included in the study. Participants must be receiving a treatment of at least ten days.

Main Variable: The scores obtained in the Euroqol5Dimensions-5Levels questionnaire (EQ-5D-5L) (for all subjects), the Western Ontario MacMaster Universities Osteoarthritis Index (WOMAC) questionnaire, for subjects with knee and/or hip osteoarthritis, and the Health Assessment Questionnaire (HAQ), for subjects with rheumatoid arthritis.

Other variables: sociodemographic, anthropometric, clinics, and related with spa treatment.

Follow-up duration: 9 months.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed arthrosis of knee or hip and/or rheumatoid arthrosis
* balneotherapy treatment of at least 10 days.
* physically and mentally able to complete questionnaires

Exclusion Criteria:

* have followed a balneotherapy treatment in the six previous month