cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.


Eligibility Criteria:
Inclusion Criteria:

* Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen
* Positive screening skin prick test (wheal diameter \> 3 mm)
* Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication
* Signed and dated patient´s Informed Consent,

Exclusion Criteria:

* Previous immunotherapy with grass and/or rye pollen extracts within the last 3 years,
* Simultaneous participation in other clinical trials,
* Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance),
* Auto-immune disorders,
* Severe chronic inflammatory diseases,
* Malignancy,
* Alcohol abuse,
* Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection,
* Patients being in any relationship or dependency with the sponsor and/or investigator,
* Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
Vitrectomy for Branch Retinal Vein Occlusion

To evaluate the long term outcomes of pars plana vitrectomy (PPV), with and without internal limiting membrane (ILM) peeling, in eyes with persistent macular edema secondary to branch retinal vein occlusion (BRVO).

Results suggest the following hypothesis:

* PPV, with and without ILM peeling, appears to be beneficial in eyes with persistent macular edema due to BRVO
* Effectiveness is maintained long term
* ILM peeling does not significantly affect postoperative best corrected visual acuity (BCVA)


Eligibility Criteria:
Inclusion Criteria:

* duration of symptoms lasting 27 weeks

Exclusion Criteria:

* vitreous hemorrhage
* severe cataract
* biomicroscopic vitreomacular traction and epiretinal membrane
* previous vitreoretinal surgery
* other ocular diseases that could contribute to visual loss.
* patients with macular branch vein occlusion
* patients with a history of previous grid laser photocoagulation
Behavioral Change Following Alzheimer's Disease (AD) Biomarker Disclosure

The proposed project will assess long-term changes to health/lifestyle, advanced planning, and research engagement that Black and White patients with Amnestic Mild Cognitive Impairment (aMCI) make following disclosure of positron emission tomography-based amyloid and tau burden and associated risk of conversion to Dementia-Alzheimer's Type. Healthcare access will be explored as potential barrier to or facilitator of behavior change.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Amnestic Mild Cognitive Impairment within the past 12 months,
* Available PET Aβ and tau imaging

Exclusion Criteria:

* Significant neurologic diagnosis (e.g., Alzheimer's dementia or other neurodegenerative dementia, Parkinson's disease, seizure disorder, tumor, multiple sclerosis)
* Neurologic injury (e.g., significant stroke or moderate-severe head injury, defined by loss of consciousness \> 5 minutes, presence of significant post-traumatic amnesia, or the need for extended hospitalization or intervention)
* Motor abnormalities indicative of a non-AD etiology
* Severe mental illness (e.g., bipolar disorder, psychosis), moderate-severe mood or anxiety disorder, active substance use disorder (o reduce the likelihood of severe psychological distress, participants must screen negative for moderate-severe depressive or anxiety symptoms at study enrollment.)
* Inability to provide independent informed consent.
Groin Complications in Open Vs. Percutaneous Peripheral Cannulation in Minimally Invasive Cardiac Surgery

The aim of this randomized trial is to investigate the groin complications in open vs percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery

The femoral artery (FA) and vein (FV) are considered the preferred site for peripheral cannulation during cardiac surgery. Normally, a small incision is made to access the FA and FV, which is also called open surgical cannulation. Afterwards, the incision site is traditionally closed with sutures (1, 2). However, groin complications such as hematoma, access-site infection and fistulas are complications that can eventually lead to a longer hospital stay (3).

Recently, suture-mediated closure systems (SMCS) have been developed to achieve hemostasis (4). This allows for percutaneous cannulation. Still, little is known about the effects on groin complications after percutaneous cannulation in cardiac surgery. Therefore, a prospective randomized study is now being conducted to investigate the groin complications in open vs. percutaneous peripheral cannulation for cardiopulmonary bypass in minimally invasive cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years
* Patients undergoing elective endoscopic cardiac surgery

Exclusion Criteria:

* Patients that do no understand Dutch, French, or English
* Heavily calcified cannula introduction site
* Central cannulation
Acceptability and Persistence of the Use of a Patient-centred E-health Tool for Lupus Patients Followed in a Specialised Centre in France

Systemic lupus erythematosus (SLE) is a complex disease whose evaluation in daily practice and clinical research requires consideration of several aspects, in particular disease activity and quality of life.

Health systems are increasingly using Patient Reported Outcome measures (PRO) data to measure different dimensions of the disease and its experience.

In addition, there is a growing number of "e-health" tools for patients. Indeed, the collection of health-related data via an electronic system makes it possible to modernise and facilitate communication between patients and doctors within the framework of medical follow-up and therapeutic education. Nevertheless, very few studies measure the acceptability and effective long-term use of such tools, particularly in the context of SLE.

The Sanoïa patient platform is a digital tool already used in therapeutic areas similar to SLE (discoid lupus erythematosus and rheumatoid arthritis), offering a guarantee of safety and a reduced individual cost.

The availability of this health-related quality of life data collection tool via a site and a mobile application adapted to patients with SLE should:

* Facilitate the collection by patients of their quality of life as part of their routine follow-up (patient access)
* Limit the impact of patients' clinical profiles on the frequency of the collection of quality of life data
* Enable internal medicine specialists to systematically use their patients' quality of life data during consultation (physician access).

This study therefore proposes to evaluate this digital platform within the framework of SLE by measuring the distribution of access by physicians according to the data reported by patients and according to the characteristics of the facilities where the subjects were recruited for the study. These data will allow us to evaluate the influence of factors extrinsic to patients on the adoption of the tool. This area has been very poorly evaluated in the few studies that have focused on the adoption of such tools.


Eligibility Criteria:
Inclusion Criteria:

* Adult \> 18 years old
* Having given oral consent for participation
* Confirmed systemic lupus diagnosis (ACR criteria)
* Regular follow-up in the centre for more than 12 months
* With Internet access at home
* Affiliated with national health insurance system or other system

Exclusion Criteria:

* Persons subject to a legal protection measure (curatorship, guardianship)
* Persons subject to limited judicial protection
* Adults who are incapable or unable to express their consent
* Patients who cannot read French
* Patients whose cognitive status does not allow them to track their health data on a digital platform
* Patients to be followed up in another centre within 12 months
Post-menopausal Women Osteoporosis(Phase III)

The purpose of this study is to evaluate the efficacy and the safety of Risedronate, cholecalciferol combination tablet in patients with Osteoporosis

The purpose of this study is to evaluate the efficacy and the safety of Monthly Risedronate with cholecalciferol on 25 Hydroxyvitamin D level and bone markers patients with osteoporosis.

Eligibility Criteria:
Inclusion Criteria:

1. women osteoporosis
2. patients with a diagnosis of Postmenopausal over 6 Months if they had a bone mineral density T-score of \< -2.5 at the mean lumbar spine (L1-4), femoral neck, or total, or a T-score of \< -1.0 with radiologic evidence of at least one vertebral fracture. Menopause was defined as no natural menses for at least 1 year and a serum FSH level \> 40 IU/L, with a reported hysterectomy
3. low levels of 25(OH)D \> 9 ng/mL
4. patients who give written consent of agreement to voluntarily participate in the clinical study
5. patients who can read and understand written instructions

Exclusion Criteria:

1. patients who had contraindications to oral bisphosphonates, such as esophageal strictures
2. ALT, AST ≥ 2×UNL and Serum Creatinine ≥ 1.5×UNL
3. low levels of 25(OH)D (less than 9 ng/mL).
4. Previous use of oral bisphosphonates and vitamin D were allowed, but a washout period was needed, depending on the duration of treatment. Two-year washout periods were needed for bisphosphonate users and 3-6-month periods were required for vitamin D users of \> 200 IU.
5. drug administration after diagnosing as alcoholic or psychical disease
6. patients whom the investigators judge as improper to participate in this clinical trial 7)13.patients who have experience to participate in other clinical trial within 30 days prior to study participation
Action of the Vidaza on the Atrial Fibrillation

Genomic studies on atrial fibrillation patients have identified polymorphisms in regions surrounding the PITX2 gene, suggesting it could be the locus responsible for atrial fibrillation. The PITX2 gene is essential for establishing the asymmetry between systemic and pulmonary blood flow, which is absolutely required for proper heart functions. In addition, PITX2 is required for the development the atrium myocardium. Investigators have performed transcriptomic analysis on left atrium tissues from atrial fibrillation patients and identify genes whose expression is altered in atrial fibrillation. Among affected genes, PITX2 expression is strongly decreased in the left atrium of atrial fibrillation patients. Moreover, investigators observed that the PITX2 promoter region is hypermethylated in atrial fibrillation patients. Interestingly, DNA methylation is a key actor of gene expression and directly regulates RNA transcription either by directly modulating transcription factor (TF) binding to gene promoters or by modifying local chromatin structures, therefore limiting access of TFs to DNA. These epigenetic modifications are reversible and therefore represent an interesting therapeutic target. Hence, many compounds that inhibit DNA methyl-transferase are currently tested in different disease models. Recently-designed hypomethylating molecules are available, such as the 5'azacytidine (Vidaza®, Celgen Inc.) or the 5-aza-2'-deoxycytidine (Decitabine) (Dacogen®, Janssen Cilag). Investigators have performed preliminary studies on the effect of Decitabine on DNA methylation and proper cardiac function recovering in a SHR model. Results indicate that the chronic delivery of Decitabine improves the arrhythmia profile by reducing tachyarrhythmia, fibrosis, as well as the oxidative stress in SHR left atrium submitted Acute Leukemia is a rare pathology with an incidence of 4 per 100,000 in France. Azacytidine, which is closely related to Decitabine, is commonly used for treating Acute Leukemia and possesses anti-neoplastic effect through multiple mechanisms, including direct cytotoxicity of blood cancer cells and DNA hypomethylation. The goal of this study is to evaluate the effects of azacytidine on arrhythmia and left atrium fibrosis as well, which are the two mains phenotypic manifestation of atrial fibrillation in humans. Investigators hypothesize that azacytidine decreases PITX2 promoter methylation and increases PITX2 expression. Hence, investigators expect to ameliorate the duration of atrium action potential and to observe a decrease of atrium fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient with history of paroxysmal atrial fibrillation, and /or presenting a dilatation of the left atrium.
* Patient selected for a first Vidaza® treatment
* Non-opposition of the patient to participate in the study

Exclusion Criteria:

* Age \< 18 years old
* No paroxysmal atrial fibrillation
* Patients with previous history of Vidaza® treatment
Neuromuscular Characteristics of Individuals With Down Syndrome (DS)

Evaluation of muscle strength and central activation of muscle in individuals with Down Syndrome


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years old
* good health with no contraindications to exercise
* documented DS (not for control subjects)

Exclusion Criteria:

* contraindications to exercise,
* severe or profound MR
* documented atherosclerotic heart disease
* documented atlantoaxial instability
* uncorrected congenital heart disease
* implanted prosthetic device
* implanted pacemaker
Nutritional Status in Children With IBD

Malnutrition and growth retardation are major extraintestinal presentations of inflammatory bowel disease (IBD) in childhood and are especially prevalent among those with Crohn's disease. We aimed to evaluate nutritional status of children with IBD at the time of diagnosis.

Data for this study will be derived from the web-based National Registry for Pediatric IBD. The children (age: ≤ 18 years) who diagnosed with IBD according to international criteria will be eligible for enrollment. Data on demographic, clinical and laboratory characteristics at the time of diagnosis were extracted from the registry. All cases in the registry will be screened for eligibility criteria by principal investigator (senior gastroenterologist). The patients with other chronic disease known affect nutritional status will be excluded. The cases who had the missing major outcome variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis will be excluded from the analysis, if they had all of these outcome variables, they were included.

The nutritional status of participants will be evaluated based on anthropometric parameters. The weight status will be assessed by weight-for-length in children \<2 years of age, and BMI-for-age in children 2 years of age and older. Height status will be evaluated by length/height-for-age in all cases. Age-and-sex specific percentile and the corresponding z score for all anthropometric parameters will be calculated in the WHOAnthro for under five years and WHOAnthroplus (WHO, Geneva, Switzerland) for those aged 5-18 years by using WHO standards and references. Z-scores between +2.0 and -2.0 for all parameters will be considered normal. Wasted/thinness and overweight will be defined by weight-for-length/BMI z score \< -2.0, and \> +2.0, respectively. Stunting (short stature) and tallness will be defined as length/height-for-age z score \< -2.0 and \> +2.0, respectively. Children will be stratified into two age groups for analysis: \< 10 years of age and older. A p value of \<0.05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≤ 18 years
2. Diagnosis of IBD with clinical, laboratory, endoscopic and histopathologic findings
3. No other chronical diseases known affect nutritional status
4. No missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis

Exclusion Criteria:

1. Age: \>18 years old
2. Another chronical disease known affect nutritional status
3. Missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis
Increasing Patient Knowledge of the Signs of Opioid Overdose and Naloxone in a Suburban Treatment Program

The purpose of this study is to determine the effect that an educational intervention has on patient knowledge of the signs of opioid overdose and appropriate use of naloxone in a suburban outpatient treatment program.

The outpatient Addiction Services program at Linden Oaks will begin implementing an educational program on the signs of opioid overdose and naloxone for all patients who have a diagnosis of opiate dependence in the investigators suburban treatment program. Subjects will be recruited from that population and administered a new, empirically validated scale (i.e. the Opiate Overdose Knowledge Scale; OOKS) both pre- and post-intervention to measure the effect that the educational program has on patient knowledge.

Patients will also be surveyed (i.e. History Survey) about their experiences over the previous 12-months (e.g. exposure to opiate overdoses, access/use of naloxone) prior to treatment; and, this History Survey will then be re-administered by phone, 1-3 months after discharge. The aim is to measure whether education influences patient behavior. Finally, all subjects will be administered an empirically-validated measure to assess subject shame and guilt (i.e. Guilt and Shame Proneness Scale; GASP), and response patterns in their behavior, to evaluate whether shame and guilt predict behavior at follow-up. The investigators will compare to data (i.e. OOKS, GASP, and History Survey) from a historical control group prior to the implementation of the educational program - and, also at 1-3 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects who have been diagnosed with a DSM opioid use disorder by LOH staff.

Exclusion Criteria:

* Subjects who are deemed to have moderate to severe cognitive impairment - as assessed by standard psychiatric evaluation from Linden Oaks clinical staff - will be excluded from the study.
Vacuum Myofascial Therapy Device and Physical Activity for the Treatment of Chronic Non-specific Low Back Pain. A Single Blind Randomized Clinical Trial

The term non-specific low back pain refers to the painful symptoms located in the lumbar region, which is delimited between the lower margin of the ribs and the lower limit of the buttocks

This study aimed to investigate the efficacy of a vacuum myofascial therapy device (VT) for improving pressure pain thresholds (PPTs), functionality, range of motion (ROM), low back pain-related disability, pain, and quality of life in patients with non-specific low back pain. Methods: A randomized controlled trial in which participants with non-specific low back pain (NP) were randomly assigned to either an experimental (VT) or a comparison physical therapy program (PTP) group.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed of Chronic Nonspecific Low Back Pain that do not improve with conventional physiotherapy or pharmacological therapy protocols.
* Subjects who are in an active state of pain

Exclusion Criteria:

* Individuals who have received surgery intervention in the spine
* Individuals have received the proposed treatment in one month´s period previously.
* Individuals who suffering from fibromialgia síndrome, cardiac patients with pacemakers, cancer, infectious processes, or generalized lymphedema.
* Pregnant women can not receive this treatment intervention.
Personalized Lifestyle Program in Treatment Resistant Irritable Bowel Syndrome

Patients with treatment resistant irritable bowel syndrome (IBS) are recruited from secondary care gastroenterology clinics in Stockholm and screened for eligibility criteria. Participants follow a 12 month treatment program at Nordic Clinic, a clinic offering personalized lifestyle interventions based on the functional medicine model. In parallel with the treatment program, the participant are clinically assessed for the evaluation of the treatment after 6 months, 12 months, 18 months and 24 months

Patients with treatment resistant irritable bowel syndrome (IBS) are recruited from secondary care gastroenterology clinics in Stockholm. Eligible participants are screened for eligibility criteria at a baseline visit at the Karolinska Institutet. Patients providing written informed consent for participation are invited to Nordic Clinic, a clinic offering personalized lifestyle interventions based on the functional medicine model. Before the first visit to the clinic, the participant fill out a longer questionnaire that is used for the planning of the participant's personal treatment program. At the first visit, the therapist goes through the responses together with the participant. Based on the participant's symptom profile, it is determined which tests are taken in the first step. Based on symptoms and test results, the therapist and participant come up with a treatment plan that can include several of the following components:

* Dietary changes
* Dietary supplements
* Measures to improve sleep / circadian rhythm
* Stress management
* Physical exercise
* Medicines, in exceptional cases.

The treatment plan is evaluated continuously by the participant and the therapist and adjusted accordingly.

The treatment involves a total of 9 visits to the Nordic Clinic during one year. The subsequent visits are planned by the therapist at the Nordic Clinic together with the participant.

In parallel with the treatment program, the participant makes return visits to Karolinska Institutet to collect follow-up data for the evaluation of the treatment after 6 months, 12 months, 18 months and 24 months after the start of treatment where participants are clinically assessed and fill out forms for the evaluation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Fulfills Rome IV criteria for IBS
* Symptom burden on IBS-SSS \>175
* No symptom relief from standard medical treatment
* No organic finding explaining the IBS symptoms (e.g. inflammation, parasites, thyroid disease, lactose intolerance, celiac disease, bile acid malabsorption)

Exclusion Criteria:

* Pregnancy
* Disease or life circumstances that prevent participation in the treatment program
The Role of Music Stimulation in Disorders of Consciousness State: an fMRI Study

The aim of the present study was to evaluated the neural effect of music on the cerebral activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by using functional magnetic resonance imaging (fMRI).

Background: Sensory stimulations were used widely to evaluate the preserved cerebral functions for these patients with disorders of consciousness. Among these, the most alerting or common stimuli are probably familiar voice and music.

Objective: The aim of the present study was to evaluated the neural effect of music on the cerebral activation in unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) by using functional magnetic resonance imaging (fMRI).

Methods: Eleven severely brain-damaged patients (6 UWS and 5 MCS) were assessed by functional magnetic resonance imaging while they were exposed under the condition of their personal music. To examine the prognostic value of these patients, longitudinal behavioral assessments were repeatedly conducted by means of the CRS-R after fMRI acquisition.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years old;
* no administration of neuromuscular blockers or sedation within the 24 hours of enrolment;
* brain damage with eye opening (indicating wakefulness and rest cycles)

Exclusion Criteria:

* Coma;
* neurodegenerative disease;
* psychiatric or neurologic illness;
* with intracranial metal or other body metal.