cyrilzakka/clinical-trials huggingface dataset:
The Effects of Hemodialysis on Serum Sclerostin Levels

Background: Parathyroid hormone (PTH) and 1,25-dihydroxy vitamin D (1,25-OHD) as well as mineral bone metabolism modulators like sclerostin are thought to play an important role in in diabetic patients with chronic renal failure. The present study aimed to analyse the levels of serum sclerostin before and after hemodialysis which is a primary element of treatment in such combined disease states.

Methods: Serum sclerostin concentrations were measured using a commercially available enzyme-linked immunosorbent assay kit with 56 individuals who 14 chronic hemodialysis patients with diabetes, 14 chronic hemodialysis patients with non-diabetes and 28 healthy volunteers as a control group.

Sclerostin results in a phenotype characterized by high bone mass (sclerosteosis) in humans, it is produced by osteocytes and chondrocytes, it suppresses osteoblast activity by inhibiting canonicular Wnt / β-catenin signal, it is described as an anti-anabolic protein of 22-kDa size.In diabetes mellitus patients osteoporosis and obesity always create problems, increased levels of sclerostin inhibit canonicular Wnt / β-catenin signal and is potentially held responsible from bone fragility. Bone problems are important both for chronic kidney disease patients and diabetes mellitus patients and in instances where these two diseases coexist, the importance of sclerostin as a new marker of bone turnover increases. The objective of this study is to evaluate how serum sclerostin levels are affected in diabetes mellitus patients undergoing hemodialysis treatment. To this end, the investigators analyzed the levels of serum sclerostin before and after hemodialysis as it is a main element of treatment in such combined disease states.

Eligibility Criteria:
Inclusion Criteria:

* Patients who satisfied inclusion criteria signed informed consent forms before they enrolled in the study.
* Chronic hemodialysis patients receiving treatment at our hospital.
* The patients had Type 2 diabetes mellitus and the patients were not diabetic.
* Healthy volunteers as a control group

Exclusion Criteria:

* Clinical diagnosis of chronic respiratory failure, acute kidney failure, nephrotic syndrome, end-stage liver disease, malignancy, acute infections
* Any health problems necessitating urgent interventions, drinking alcohol and/or smoking as well as pregnant patients
Music Listening to Reduce Pain and Anxiety During LEEP

Loop electrosurgical excision procedure (LEEP) is the primary diagnostic and therapeutic procedure employed in women with high-grade intraepithelial neoplasia of the cervix. The procedure usually performed in the outpatient setting under local anesthesia. However, it could be associated with significant pain and anxiety.

The aim of this study is to examine the effects of listening to music during the procedure in reducing pain and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Women with confirmed or suspected high-grade intraepithelial neoplasia of the cervix

Exclusion Criteria:

* Allergy to local anesthetic agent (lidocaine)
* Pregnancy
* Previous major surgical procedures on cervix (conization, LEEP, laser therapy, cryotherapy) or uterus
* Using cardiac pacemaker or history of cardiac arrhythmia
* Neurological disorder affecting perception of pain
* History of lower urinary tract cancer
* Coagulation defects
* History of drug dependence
* Lower genital tract infection
* Apparent invasive cancer of the cervix
* Hearing difficulty
Red Meat, Increased Iron Load and CVD Risk

Increased iron load could be a risk factor for cardiovascular diseases (CVD). Red meat consumption affects iron status and has also been shown to be related to increased CVD risk. The investigators hypothesized that risk associations between red meat intake and cardiovascular disease risk can to some degree be explained by higher iron load among individuals with higher meat intake. Thus, the investigators evaluate associations between red meat consumption, iron status, and CVD risk in a large-scale population based study, the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg.

The present study part of the the European Prospective Investigation into Cancer and Nutrition (EPIC) - Heidelberg, a large-scale observational cohort study located at the German Cancer Research Center, Heidelberg, Germany. The study started between 1994 and 1998, when 25 540 adults from the local general population were recruited. Study participants are being followed-up by active and passive procedures. The main aim of the study is to evaluate associations between diet, lifestyle as well as metabolism and risks of major chronic diseases (cancer, cardiovascular diseases, diabetes).

Here, the investigators register a project from within EPIC-Heidelberg on prediagnostic iron status as a potential mediator of associations between pre-diagnostic red meat consumption and cardiovascular disease risk. For this particular project, an embedded case-cohort set-up was chosen, i.e. iron status markers (primary marker: serum ferritin; secondary markers: serum transferrin, serum iron) were measured in baseline blood samples from a random subcohort (n=2738) and all validated incident cases of myocardial infarction (n=556), stroke (n=513), and CVD death (n=327) that occured until the closure date of the present study (12-31-2009).

Statistical analyses follow four steps to assess whether iron status may mediate associations between red meat consumption and CVD risk, as proposed by Wittenbecher et al. (Am J Clin Nutr, 2015: www.ncbi.nlm.nih.gov/pubmed/25948672):

1. Multivariable Cox regression analyses on red meat consumption and CVD risk, assuming a significant positive association
2. Multivariable linear regression analyses on red meat consumption and iron status, assuming a significant positive association
3. Multivariable Cox regression analyses on iron status and CVD risk, assuming a significant positive association
4. Multivariable Cox regression analyses on red meat consumption and CVD risk, additionally adjusting for iron status, assuming that the association will be attenuated by adjustment for iron status

Eligibility Criteria:
Inclusion Criteria:

General population, age 35-65 years

Exclusion Criteria:

Prevalent myocardial infraction or stroke
Overlap FGIDs and Genetic Polymorphism

1. To analyze the prevalence of overlap syndromes among NERD or RH, FD, and IBS patients, and to identify and to compare the differences in their characteristics and symptoms, and to determine their risk factors.
2. To identify the differences in clinical features according to sex and gender.
3. To analyze the effect of genetic polymorphisms on overlap FGIDs over long-term follow-up period.


Eligibility Criteria:
Inclusion Criteria:

FGID group

* No organic diseases in routine laboratory tests, abdominal imaging, esophagogastroscopy, and colonoscopy
* NERD or reflux hypersensitivity (RH): typical heartburn occurring at least once a week without visible esophageal mucosal break detected by endoscopy
* FD or IBS: based on the Rome III criteria

Control group

- Subjects who underwent GI evaluations as part of health check-up or for other problems, such as mild abdominal discomfort or pain for a relatively short period of time, but had no organic problems during GI endoscopy

Exclusion Criteria:

* history of GI surgery except appendectomy
* inflammatory bowel disease
* any malignancy, or systemic diseases requiring chronic medication except for hypertension and diabetes mellitus
* pregnant or lactating women
* hepatic, biliary, or psychiatric disorders requiring medication.
Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer

The purpose of this first-in-man study is to evaluate safety and tolerability of ODM-208 in patients with metastatic castration-resistant prostate cancer.

Safety and tolerability profile of ODM-208 will be explored

Eligibility Criteria:
Main Inclusion Criteria:

* Written informed consent (IC) obtained.
* Male aged ≥ 18 years.
* Histologically confirmed adenocarcinoma of the prostate.
* Castration resistant prostate cancer with serum testosterone \< 50 ng/dl.
* Metastatic disease.
* Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
* Received at least one prior line of novel hormonal androgen receptor (AR) targeted therapy (e.g. abiraterone, enzalutamide).
* ECOG performance status 0-1.
* Adequate marrow, liver and kidney function.
* Able to swallow study treatment.
* Part 1: Treatment with at least 1 line of chemotherapy or ineligibility for chemotherapy. Part 2: Treatment with at least 1 line of taxane-based chemotherapy in castration-sensitive prostate cancer (CSPC) or in CRPC.

Main Exclusion Criteria:

* History of pituitary or adrenal dysfunction.
* Known brain metastases or active leptomeningeal disease.
* Active infection or other medical condition that would make corticosteroid contraindicated.
* Poorly controlled diabetes.
* Hypotension or uncontrolled hypertension.
* Clinically significantly abnormal serum potassium or sodium level.
* Active or unstable cardio/cerebro-vascular disease including thromboembolic events.
* Prolonged QTcF interval.
Nasal Desmopressin Versus Topical Epinephrine in Endonasal Dacryocystorhinostomy

Dacryocystorhinostomy aims to create a channel between the lacrimal sac and nasal mucosa to relieve nasolacrimal duct occlusion. General anesthesia is still preferred by many surgeons to secure the airway and control blood pressure.

Bleeding even minor can obscure the surgical field. This can extend the operative time \& increase the failure rate. The hemostatic effect of desmopressin on the quality of the surgical field was investigated in patients undergoing endoscopic sinus surgery and revealed that desmopressin could reduce intraoperative bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-45 years old.
* Physical status: ASA I \& II.
* Type of operations: elective endonasal dacryocystorhinostomy under general anesthesia.
* Written informed consent from the patient.

Exclusion Criteria:

* Patient refusal.
* Known hypersensitivity to study drugs.
* Nasal pathology as active infection or an anatomical abnormality.
* Hyponatremia "serum Na+ less than 135".
* Coagulation disorders.
* Renal or cardiovascular disorders.
Innovative Device for Pain Management by Millimeter Band Radiation: Electronic-Pain Killer

The objective of this study is to evaluate a new medical device in the management of pain. The principle of this new treatment is based on the emission of electromagnetic radiation in millimeter band. This new modality of pain management is evaluated in a perioperative management in patients undergoing surgery for aortic valve replacement.

The hypothesis is that the use of this medical device in perioperative would reduce the consumption of postoperative morphine with an identical quality of analgesia. The decline in morphine consumption would allow a decrease in opioid adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* candidate for an aortic valve replacement with extra-corporal flow.
* wrist size between 14.5 and 18.5 centimeters (for the experimental group)
* patient affiliated to social security
* signature of the informed consent (for the experimental group)

Exclusion Criteria for the control group :

* patient with diabetes
* patient with an evolutive cancer
* patient with cardiac assistance
* patient under the influence of opioid in the 48 hours before the surgery
* patient deprived of liberty by judicial or administrative decision
* patient subject to legal protection or unable to express his consent (guardianship or curators)

Exclusion Criteria for the experimental group :

* patient with diabetes
* patient with an evolutive cancer
* patient with surgery planning within 48 hours
* patient with cardiac assistance
* patient under the influence of opioid in the 48 hours before the surgery
* patient suffering from a dermatological disease such as oozing dermatitis, hyper sweating, or an unhealed lesion in the wrists.
* patient who has a piercing in the wrist or another metal material
* patient known for having a multi-resistant bacterial strain
* protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
* exclusion period of another interventional study
Prevalence of Severe Asthma in Spanish Hospitals

Asthma is a chronic disease. Prevalence of asthma in 2014 among Spanish population was 5%, of which 10% were diagnosed with severe asthma. According to Spanish National Guideline for the Management of Asthma (GEMA) 4.1 criteria, asthma can be classified according to its severity (intermittent, mild persistent, moderate persistent or severe persistent) or level of asthma control (controlled, partly controlled or uncontrolled). This Guideline describes that only 1 in 10 subjects with severe asthma is well controlled, meaning that there is a 90% prevalence of non-controlled severe asthma.

This prospective, non-interventional, observational, multicenter and case-control study aims to assess the prevalence of severe asthma in Spanish Hospitals. The study will describe the characteristics of severe versus non-severe asthmatic subjects, assess their eligibility to receive biological treatments approved for this disease, resource consumption and evaluate the most prevalent phenotypes of severe asthma in Spain. Enrolled subjects will be divided into two cohorts, based on asthma severity according to the Global Initiative for Asthma (GINA) and the International European Respiratory Society (ERS)/American Thoracic Society (ATS) Guidelines. Cohort A: subjects diagnosed of severe asthma and Cohort B: subjects with non-severe asthma. Approximately 320 severe asthmatic subjects and 160 non-severe asthmatic subjects will be enrolled in the study. A software of big data will be used to do a sub study for comparing the results obtained through this software tool against results obtained through Gold standard classical methods used in this prospective observational study (the descriptive assessment of severe asthma prevalence and the prospective evolution of subjects).


Eligibility Criteria:
Inclusion Criteria

* Group A: Subjects with Severe asthma can be enrolled, when they fulfill the following criteria:
* Subjects \>= 18 years
* Subjects diagnosed with "severe asthma" defined as asthma that requires high-dose inhaled corticosteroids (ICS) plus Long-Acting Beta2-Agonist (LABA), leukotriene modifier/ theophylline in the last 12 months or continuous/almost continuous treatment with systemic glucocorticosteroids (CS) for \>= 50% of the previous year to maintain control of asthma
* Subjects treated with ICS/LABA, with the maximum dose recommended by Specific Product Characteristics (SPC).
* Subjects who give voluntary written informed consent after explanation of study´s procedures.
* Group B: Subjects with Non-Severe asthma can be enrolled, when they fulfill the following criteria:
* Subjects \>= 18 years
* Subjects diagnosed with non-severe asthma per GINA Guidelines Classification
* Subjects who give voluntary written informed consent after explanation of study´s procedures

Exclusion Criteria

* Subjects who are not able to complete all the follow-ups of the study with all the study procedures
Gut Peptides and Intestinal Permeability in Celiac Disease and Irritable Bowel Syndrome

It is well known that the intestinal barrier is altered in celiac disease (CD), an autoimmune disease that develops in genetically predisposed subjects exposed to ingestion of wheat gliadin and of related prolamines of barley and rye. More recently, defective epithelial barrier has been implicated in the pathogenesis of other conditions such as irritable bowel syndrome (IBS). At present IBS is still considered a functional condition although low-grade inflammation has been associated with its manifestation, particularly that following infection. Different substances have been implicated in the (dis)regulation of intestinal barrier, among them zonulin seems to play a key role. Other gastrointestinal peptides are GPL-2, Ghrelin, and Epidermal growth factor (EGF). In order to shed light on the hormonal regulation of intestinal barrier function in celiac patients before undergoing a gluten free diet and possible differences with those of IBS patients, in the present study the investigators will apply the non-invasive lactulose/mannitol permeability test toward the evaluation of intestinal damage. The pattern of intestinal permeability and the GI peptides concentration will be compared in celiac patients, IBS patients and healthy controls.


Eligibility Criteria:
Inclusion criteria of celiac disease patients:

* Diagnosis of CD was based on the detection of IgA antiendomysial and IgA antitissue transglutaminase antibodies in serum
* Diagnosis must be confirmed by a small intestinal biopsy obtained at the time of gastrointestinal endoscopy.
* All patients must show Marsh 3 grade villous atrophy at the time of the diagnosis.

Inclusion criteria of IBS patients.

* Subjects suffering from irritable bowel syndrome according to the Rome III criteria.
* Availability of at least one GI imaging study during the last five years (colonoscopy, sigmoidoscopy, abdominal ultrasound, barium enema)

Exclusion criteria for both the above groups:

* None were taking anti-inflammatory drugs (including mast cell stabilisers, histamine antagonists, anticholinergics, anti-diarrhoea medication, probiotics, immunosuppressants and steroids)
* Presence of organic syndrome, including food allergy, atopy and severe clinical depression or anxiety.
* Abnormal laboratory data or thyroid function
* Major abdominal surgery Healthy subjects will be recruited in the administrative staff of the Institute after thorough exclusion of GI symptoms.
Visuo-Tactile Integration and Body Ownership in the Human Brain

The present project exploits brain imaging and neuroscience robotics to investigate the role of quantifiable visual input on the relationship between visuo-tactile integration and body ownership (the feeling that "this" body belongs to "me").

Observational study, fundamental research, multicentric, national. The analysis of questionnaires, self-reports, and brain imaging associated with the RHI is used to understand the influence of visual input on body ownership. To this aim, participants lay down in the magnetic resonance (MR) scanner (Figure 1B), are presented with visual stimuli (videos of the virtual rubber hand - visual stroking) simultaneously in real time with tactile stimuli (robotic stroking of the participant's hand - tactile stroking), and in combination or not with the measurement of autonomic arousal (GSR) associated with the observation of a video showing the virtual rubber hand in a threatening situation (e.g. a knife approaching the virtual hand - unconscious RHI effects). By means of structured questionnaires and semi-structured self-reports, participants (i) evaluate eventual sensations felt during the visuo-tactile stimulation and (ii) report the personal feelings and impressions about body ownership for the virtual rubber hand (conscious RHI effects).

Eligibility Criteria:
Inclusion Criteria:

* general health
* personal interest
* age between 18 and 55 years old
* fulfil standard guidelines for fMRI studies

Exclusion Criteria:

* history of seizures, epilepsy
* specific medications or treatment
* concomitant diseases (e.g. cardiopathy)
* pregnancy
* unexplained loss of consciousness
* chronic headaches
* neurological illnesses
* head concussion,
* presence of metal in the neck or head
* implanted medical devices
* drug abuse
* inability to give consent
Sensory Versus Motor Level Neuromuscular Electrical Stimulation

Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support these different modes of stimulation is lacking. This study compared the effectiveness of sensory and motor level stimulation on post-stroke dysphagia.

Objective: Dysphagia is a serious cause of morbidity and mortality in stroke survivors. Electrical stimulation is often included as part of the treatment plan for dysphagia, and can be applied at a sensory or motor level intensity. However, evidence to support sensory versus motor stimulation is lacking. This study compares the effect of sensory and motor stimulation on post-stroke dysphagia.

Design: Randomized controlled trial

Setting: Inpatient rehabilitation facility.

Participants: Participants (50-75 years of age) who had dysphagia caused by a stroke within 6 months prior to enrollment were included. Participants were excluded if they had a contraindication for electrical stimulation, previous stroke, psychiatric disorder, contraindications for MBS, or pre-stroke swallowing disorders.

Interventions: Each patient received ten, 45-minute anterior neck sensory or motor level electrical stimulation sessions in addition to standard speech therapy. Motor stimulation was administered as a stimulus intensity sufficient to produce muscle contractions. Sensory stimulation was defined as the threshold when the patient feels a tingling sensation on their skin (approximately 4-5mA).

Main Outcome Measures: Swallow FIM, National Outcome Measurement System (NOMS), Dysphagia Outcome Severity Scale (DOSS), and change in modified diet.

Eligibility Criteria:
Inclusion Criteria:

* 18-80
* acute ischemic CVA within the first month and confirmed by MRI.
* Diagnosis of dysphagia will be obtained by bedside swallowing exam and MBS/FEES studies.

Exclusion Criteria:

* patients who have contraindications for electrical stimulation (malignancy, DVT/thrombophlebitis, hemorrhagic conditions, pregnancy, pacemaker or other electrical hardware)
* known premorbid swallowing disorders
* GERD
* dementia or psychiatric disorder
* bilateral cerebral involvement
* contraindications for FEES/MBS (infectious disease such as HIV, HCV, HBV, nasal obstruction, decompensated heart disease, risk of bleeding such as active ulcers, allergy to contrast).