cyrilzakka/clinical-trials huggingface dataset:
Doxazosin Effects on ABPM in Hypertensive Patients With Diabetic Nephropathy

Few studies have reported the effect of alpha1-adrenergic antagonists on 24-h blood pressure and regulation of sympathetic nervous activity in hypertensive patients with diabetic nephropathy. Using ambulatory blood pressure monitoring devices equipped with spectral analysis of heart rate variability, we assess the effects of doxazosin on blood pressure in diabetic nephropathy patients and compare the results with those in patients with essential hypertension, patients with diabetes mellitus and patients with chronic nephropathy.

The study is an open-labeled parallel prospective trial comparing the effects of doxazosin (2-8 mg/day) on 24-h blood pressure and autonomic nervous activity. Hypertensive patients with non-insulin-dependent diabetic nephropathy, patients with essential hypertension, patients with diabetes mellitus and patients with chronic nephropathy undergo ambulatory blood pressure monitoring before and after treatment with doxazosin. Simultaneously, spectral analysis is performed to calculate the high frequency components as a marker of parasympathetic nervous activity, and the low frequency components/high frequency components ratios as an index of the sympathovagal balance.

Eligibility Criteria:
Inclusion Criteria:

* Hypertensive patients with diabetes mellitus
* Hypertensive patients
* Hypertensive patients with renal disease

Exclusion Criteria:

* Cardiac, hematologic or hepatic disease
* Renal insufficiency (serum creatinine values\> 2 mg/L)
* Hormone-induced hypertension
* Cerebral infarction or hemorrhage
* Other major diseases
Does Increase in Appetite After Iron Treatment Induced by Ghrelin Hormone

The purpose of this study is to examine whether iron therapy in patients with intravenous iron deficiency anemia causes an increase in appetite. And whether this increase is mediated by the hormone ghrelin.

Prior to Iron treatment Investigator will sample subject blood for: counting blood, iron sector indices, renal function, electrolytes, and measure the level of ghrelin fasting plasma. In addition, the patient will fill a structured questionnaire that examines appetite levels. participants will be asked to answer a structured questionnaire which will include information on demographics, clinical data (fever, allergies, weight, height) and comorbidities. Additional data on laboratory tests, comorbidities, medication and regular blood and urine cultures results will be taken from the medical file. Iron treatment will be given according to local standard procedure . At the end of the treatment ghrelin levels and questionaire will be retaken .

iron deficiency anemia is defined: hemoglobin \<12 gr / dl in women and Hb \<13 gr / dl in men with ferritin \<15 ng / ml.

Eligibility Criteria:
Inclusion Criteria:

* Iron deficiency anemia that wasn't responded to oral treatment or wasn't tolerable due to side effects
* sign and dated informed consent form.

Exclusion Criteria:

* chronic inflammatory disease.
* chronic renal failure
* active cancer.
* active Infectious disease.
* non iron deficiency anemia.
* pregnancy.
Sedation Techniques for Outpatient Colonoscopy

This was a prospective, randomized, single-blind controlled clinical trial comparing three sedative regimens for outpatient colonoscopy.

This was a prospective, randomized, single-blind controlled clinical trial comparing target-controlled infusion (TCI) with propofol and patient-controlled sedation (PCS) with propofol, to conventional combination of midazolam and pethidine, in terms of quality and safety of sedation, and patient recovery during outpatient colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II patients
* aged between 18 to 80 years
* scheduled for outpatient colonoscopy

Exclusion Criteria:

* history of or with psychiatric disease
* on psychoactive drugs
* mentally or physically unable to use the hand-held device for PCS
* previous complications from anaesthesia or sedation
* potentially difficult airway maintenance
* obstructive sleep apnoea
* pregnant
* with contraindications to the study drugs
Efficacy of Polyglucosamine for Weight Loss

The polyglucosamine, specification L112 is a medical device and in this clinical trial used for weight reduction of overweight and obese participants. The rationale for this study is to show that overweight can be reduced by taking 2 times daily 2 tablets with the main meals with the highest fat content.

To have a comparable diet condition, all participants in both groups had to follow the recommendations of the German clinical practice guidelines on the management and prevention of obesity.

One group had to take the polyglucosamine tablets and the other group placebo tablets for at least 24 weeks. It is known, that polyglucosamine is a fat binder acting in a physical-chemical manner, the positive charged fiber is bound to the negative charged dietary fat and this complex in unable to pass the gut wall into the body but is naturally excreted, hence this energy is not available. Therefore, this medical device should show a measurable reduction in body weight.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 26 and \< 45
* waist circumference of more than 88 cm for women and greater than 102 for men.

Exclusion Criteria:

* pregnancy or breast-feeding, alcohol abuse, drug abuse or drug addiction, inability to fulfill the criteria of the trial protocol, cancer diseases, malignant tumors, pre-existence of chronic intestinal disease and known hypersensitivity reactions to crustaceans
Effects of a Combined Supplementation of Conjugated Linoleic Acid (CLA) and Probiotics (Vivomixx®) as add-on to a First-line Immunotherapy in Relapsing-remitting Multiple Sclerosis

The goal of this randomized, double-blind, placebo-controlled multicenter study is to investigate whether the combination of food supplementation with Tonalin® and specific probiotics is a safe and effective add-on to first-line disease modifying treatment (DMT, interferon-beta derivatives as well as glatirameracetate and other glatirameroids) in relapsing remitting MS (RRMS).

100 patients will be randomly assigned in a 1:1 ratio to receive either both food supplements for 48 weeks or to receive placebo in addition to their established first-line disease modifying treatment (DMT). The two randomized groups will be compared concerning the change in volume of T2-weighted hyperintense lesions from baseline to 48 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Relapsing-remitting multiple sclerosis according to current McDonald Criteria, EDSS maximal 5.5, 18-60 years
* stable treatment with first-line DMT (IFNbeta, teriflunomide or glatiramer acetate/ other glatirameroids) for at least 6 months
* absence of a clinical relapse for at least 3 months before inclusion
* Written informed consent

Exclusion Criteria:

* diagnosis of primary or secondary progressive MS or other active autoimmune disease
* intake/administration of the following disease modifying therapies:

  1. at any time point: alemtuzumab, cladribine
  2. during the last 6 months before inclusion: natalizumab, fingolimod, dimethyl fumarate, siponimod
  3. during the last 12 months before inclusion: mitoxantron, ocrelizumab, ofatumumab, rituximab
* ingestion of other dietary supplementation (e.g. vitamins, probiotics, iron, calcium, prebiotics, such as omega-3-fatty acids)
* significant gastroenterological abnormality (e.g. inflammatory bowel disease, short bowel disease, preexisting digestive lesions)
* accompanying systemic immunosuppressive treatment
* relevant dietary restriction (e.g. strictly vegan nutrition)
* women during pregnancy or lactation
Optimal Exercise Regimens for Persons at Increased Risk

To assess exercise training adherence and compliance over two years in subjects who were at relatively high risk for coronary artery disease. Also, to test strategies for improving adherence and compliance and to assess the effect of exercise training.

BACKGROUND:

Regular physical exercise is associated with lower coronary heart disease mortality, favorably affects coronary risk factors, and increases cardiovascular functional capacity. Fewer than one-third of Americans engage in regular physical exercise and only 20 percent of men and 10 percent of women over age 45 do so. This is largely because effective strategies for increasing the exercise habit in a broadly-based segment of Americans have not been developed. This study applied physiological and behavioral knowledge derived in numerous laboratories over the past 10-15 years to a clinical setting.

DESIGN NARRATIVE:

Following stratification by gender and cigarette smoking status, subjects were randomized to one of four groups: home exercise of moderate intensity which was individually monitored; home exercise of high intensity which was individually monitored; exercise of high intensity which was group supervised; and a no program control group. The intervention program was conducted for one year followed by a one-year maintenance program. Main outcome measures included treadmill exercise test performance, exercise participation rates, and heart disease risk factors. Variables measured over two years included plasma lipids, lipoproteins, apoproteins, lipase activity, glucose and insulin, sex hormones, cardiovascular reactivity to psychological stress, cigarette smoking, nutrient intake, psychological status, and cardiovascular functional capacity.

Eligibility Criteria:
Sedentary men and women, ages 50 to 65. Women were postmenopausal and not taking hormone replacement therapy. All subjects were free from, but at increased risk for, coronary heart disease.
Self-management in Chronic Obstructive Pulmonary Disease (COPD) Patients Compared to Usual Care

Evaluation of the effectiveness of COPD self-management interventions compared to usual on Quality of life, functional status, patient education, depression, and anxiety in primary healthcare users in the prefecture of Heraklion, Greece.

To the best of our knowledge, no previous study has examined the effects of self-management programs on patients with COPD in Greece. Therefore, the investigators conducted a randomized controlled trial with a post-test design, to evaluate the implementation and clinical effectiveness of a COPD self-management intervention compared to usual care in terms of the following outcomes: Quality of life, functional status, patient education, depression, and anxiety.

Eligibility Criteria:
Inclusion Criteria:

* patients aged ≥18 years
* had previously been given a physician-diagnosis of mild COPD
* stable on their medications (no treatment modifications) in the last three months
* able to speak, read and/or understand Greek

Exclusion Criteria:

* refusal to participate
* concurrent oncological diseases
* severe cognitive impairment
* neurological, or psychiatric disability
Mouth Handicap in Systemic Sclerosis

In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.

Systemic Sclerosis is an autoimmune connective tissue disease with fibrosis. Although its etiology and pathogenesis have not been clearly defined, it has a chronic course. Systemic sclerosis is estimated to affect approximately 300,000 people in the United States. Most commonly, it affects adults and women.

Narrowing of the mouth opening and mouth pain are the two most important causes reported by adults with systemic sclerosis. In patients with systemic sclerosis, orofacial findings such as microstomy or reduced mouth opening are frequently seen. Microstomy is defined as the distance between the incisors is less than 40 millimeters. In severe microstomy, this distance is less than 30 millimeters. It is approximately 33 millimeters in adults with systemic sclerosis. Microstomy in systemic sclerosis mainly results from submucosal collagen deposits that contribute to fibrosis in the perioral tissue. Microstomy is seen in 43% to 80% of adults with systemic sclerosis.

When the current literature is examined, Bongi et al. evaluated the effectiveness of face-specific programs, which are applied together with general rehabilitation programs in patients with systemic sclerosis; they demonstrated that these techniques improve disability, health-related quality of life (HRQoL), and facial functionality.

In this study, it is aimed to investigate the mouth handicap in Systemic Sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with systemic sclerosis
* Stability of medical treatments
* Turkish literacy

Exclusion Criteria:

* The patient has a history of neurological disease or trauma that may affect his symptoms
* Oral treatment for the last 6 months
* Being in active phase of the disease
* Skin infection and presence of open wound
* Having used dental orthosis in the last month
* Disorder of cognition or cooperation
HRV and Coaching Preparation Phase Study

This pilot study will evaluate possible intervention components to be included in a future stress management and health behaviour change trial and to pilot test their feasibility and acceptability in a small sample.

Work is one of the greatest contributors to chronic stress. Chronic stress is a critical risk factor leading to several negative work- and health-related outcomes. Developing scalable stress-management interventions will improve workers' health and wellness. The purpose of this project is to develop an optimized a stress reduction behavioural coaching and biofeedback intervention to supplement an existing mHealth platform (consisting of behavioural web-based modules). By testing coaching and biofeedback, this project can determine what level of interaction with a trained coach is necessary to optimally reduce workers' stress, and improve their health and well-being. To achieve this purpose, the multiphase optimization strategy (MOST) will be employed to develop, optimize, and evaluate the efficacy of this intervention. The three-phases include: preparation (selecting which intervention components are feasible to examine), optimization (determining the optimized package of components), and evaluation (evaluating the efficacy of the optimized package through a randomized control trial). This trial will cover the first phase of the MOST protocol. This pilot study will evaluate possible intervention components to be included in a future stress management and health behaviour change trial and to pilot test their feasibility and acceptability in a small sample.

Preparation phase objectives:

1.1 Determine which candidate components will be tested in a later optimization phase and at what dose they will be tested 1.2 Examine the feasibility of delivering the different components 1.3 Examine the acceptability of delivering the different components 1.4 Evaluate whether the outcomes can be feasibly measured

Design overview: A 2\^4 (2x2x2x2) factorial experiment will run in the next phase of this project to test all combinations of four candidate components "turned on and off" with 16 different conditions. In the present study, we will ask 16 participants to each participate in and evaluate one of the sixteen conditions. The four candidate components being tested are: Daily resting HRV biofeedback, Momentary HRV biofeedback, Behavioural initiation coaching, and Practice with feedback coaching. Additionally, all participants will be asked to use complete the 8-week health behaviour change and stress management program on the Core health mHealth platform. Participants will be randomized to completing one of the sixteen conditions while completing the eight-week CoreHealth program.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Able to read and comprehend English
* Have smart phone (Android or iPhone 8 or higher)
* Self-report BMI under 40
* report at least Moderate daily stress

Exclusion Criteria:

-
MAD Study of NX210c

This study will investigate the safety and tolerability of multiple intravenous infusions of NX210c with two ascending doses as well as NX210c pharmacokinetics (PK), and pharmacodynamics (PD) effects in healthy elderly subjects.

The prevalence of neurocognitive disorders (NCD), including neurodegenerative diseases (NDDs) such as Alzheimer's disease (AD) is increasing. NDDs are most common and prevalent in elderly people worldwide and cause progressive neuronal dysfunction, toxicities, and death. These diseases lead to an irreversible weakening of all brain functions, including cognitive impairment. There is not one single cause of cognitive impairment but rather several factors that can contribute to trigger or accelerate cognitive decline.

Preclinical in vitro and in vivo data have shown that NX210c exhibits important properties, which may be suitable for the treatment of neurological disorders in humans. (i.e., neuroprotection, neuro-regeneration, synaptic transmission, positive effects on cognition, anti-neuroinflammatory action).

The First In Human Single Ascending Dose study has been completed. In that study, NX210 was administered and well tolerated. The current project is a multiple ascending dose (MAD) study and designed to investigate the safety, tolerability, PK and pharmacodynamics (PD) effects of multiple intravenous infusions of NX210c in two dose levels in healthy elderly subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male or female participants, as determined by the Investigator, based upon a medical evaluation including medical history, physical examination, neurological examination, MMSE, MRI, lab tests and ECG.
* Aged ≥ 55 years, inclusive at screening, and with a maximum weight of 110 kg.
* Body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening.

Exclusion Criteria:

* Evidence of any history, or any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator
* History of any known neurologic disease, cognitive impairment, or diagnosed decline in cognitive function abnormal related to the age, or history of seizure, (significant) head trauma, loss of consciousness, or significant neuroimaging findings, including but not limited to any previously known or discovered abnormalities on screening brain MRI that evoke neurological diagnosis indicative of clinically significant abnormality
Examination of Transcranial Focused Ultrasound on Brain Activity in Adults

The investigators aim to examine the immediate effect of transcranial focused ultrasound (tFUS) on brain activity in healthy adults.

The investigators will examine ventral striatum (VS) target engagement by tFUS in healthy adults using a reward processing task that reliably activates the VS.

Eligibility Criteria:
Inclusion Criteria:

* No present/lifetime history of major depressive disorder (MDD), psychosis, Bipolar Disorder; Hamilton Depression Rating Scale (HDRS)\>7; Young Mania Rating Scale (YMRS)\>10), borderline personality disorder, and present suicidal ideation
* No family history of MDD, psychosis, Bipolar Disorder, or epilepsy

Exclusion Criteria:

* Present/lifetime history of MDD, psychosis, Bipolar Disorder (HDRS\>7; YMRS\>10), borderline personality disorder, and present suicidal ideation. Childhood history of, but not present, anxiety disorders and Attention-deficit/hyperactivity disorder (ADHD) will be allowed as these are common disorders in childhood
* Family history of MDD, psychosis, Bipolar Disorder, or epilepsy
* History of head injury, neurological (e.g., epilepsy), pervasive developmental disorder (e.g., autism), systemic medical disease and treatment (medical records, participant report)
* Use of substances with seizure risk (e.g., stimulants) in the past month, as for other non-invasive neuromodulation techniques, assessed as screening and before each tFUS session
* Mini-Mental State Examination (MMSE) score (cognitive state) \<24
* Premorbid North American Adult Reading Test (NAART) intelligence quotient (IQ) estimate \<85;
* Visual disturbance: \<20/40 (Snellen visual acuity)
* Left/mixed handedness (Annett criteria)
* History of alcohol or other substance use disorder (SUD), daily nicotine use, and/or illicit substance use over the last 3 months (SCID-5). Note: lifetime/present cannabis use (\<3 times in the past month) at non-SUD levels will be allowed, given its common usage in young adults. Urine tests on scan days will exclude current illicit substance use. Salivary alcohol tests on scan days will exclude intoxicated individuals
* Binge drinking (as defined by National Institute on Alcohol Abuse and Alcoholism (NIAA) criteria: consuming 5 or more drinks (male), or 4 or more drinks (female), in about 2 hours.) in the week before, and/or \>3 drinks/day for the 3 days before, and/or alcohol in the last 12 hrs before, any alcohol on tFUS scan day, confirmed at screening and scan days. Alcohol/nicotine/caffeine/cannabis use (below SCID-5 SUD and binge levels) will be allowed
* MRI exclusion criteria: metallic objects, e.g., surgical implants; claustrophobia; positive pregnancy test for females or self-report pregnancy
* Unable to understand English
* Taking any psychotropic medications in the past 3 months
* Any implanted neural device
Study of the Role of Oncostatin M in Head and Neck Squamous Cell Carcinoma

The ROMCOR study will be interested in the impact and the role of oncostatin M (OSM), a cytokine belonging to IL-6 superfamily, in the physiopathology of head and neck squamous cell carcinoma. The study team will study the impact of the presence of OSM and its main receptor OSM-R2 on several survival outcomes (overall survival, progression free survival) by multiple technics such as immunohistochemistry, transcriptomic in situ assays and spatial transcriptomic. Furthermore, the study team will try to show a link between serum level of several cytokines and in situ tumoral OSM.


Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age;
* with suspected squamous cell carcinoma of the oral cavity, oropharynx or pharyngolarynx (any stage);
* with healthy, untreated contralateral mucosa and no contraindications to biopsy;
* with no history of any type of cancer;
* with a WHO performance status index of 0 to 2 inclusive ;
* able to receive treatment according to current European Society of Medical Oncology guidelines ;
* without guardianship, curatorship or subordination;
* benefiting from a Social Security scheme or benefiting from one through a third party;
* have given informed consent to participate in the study.

Exclusion Criteria:

* previously pre-treated in the ear, nose, throat sphere by radiotherapy or having already received anti-cancer chemotherapy;
* on long-term immunosuppressive therapy, defined as taking an immunosuppresseur, identified as such in the ATC classification, for 7 days, cortico-therapy \> 7.5mg/day for more than 3 months, treatment or history of anti-CD20 treatment within the year, or regular plasmatic exchange or gamma globulin infusion;
* benefiting from enhanced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection;
* pregnant or breast-feeding women of childbearing age (menopause must be documented and more than 2 years old) who refuse or do not have an effective method of contraception (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy) for the duration of the study.
* final diagnosis of non-squamous cell carcinoma