cyrilzakka/clinical-trials huggingface dataset:
Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder

This project aims to comparing the effectiveness of transcranial direct current stimulation with common pharmacological treatments on behavioral problems and cognitive deficits of children with autism spectrum disorder

45 children with autism spectrum disorder are recruited in Fatemi Hospital at Ardabil University of Medical Sciences. The patients will be randomized into 3 Intervention groups of 15 with tDCS stimulation, risperidone, and placebo medication as the interventions. The study will be a randomized double-blind controlled design. The experimenter and the patient are blinded and are not aware of the study. Intervention group 1: TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the F3 and cathodal electrode will be placed over the Fp2. They will also receive a placebo tablet (Galenus pharmaceutical company) in each stimulation session. Intervention group 2: Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days. Intervention group 3: Participants in this group undergo 10 daily sessions of sham tDCS concurrent with a placebo tablet (Galenus pharmaceutical company) for 10 consecutive days.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism spectrum disorder by a psychiatrist and behavioral checklist
* being 6-16 years old
* providing written informed consent signed by parents

Exclusion Criteria:

* comorbidity with other neurodevelopmental disorders
* comorbidity with other neurological disorders
* previous history of neurosurgery
* presence of any ferromagnetic metal in the head
* implanted medical devices in the head or neck region
* history of noncontrolled epilepsy with seizures in the last year
A Study of the L-PPDS With Adjunctive Xalatan® Eye Drops in Subjects With OH or OAG

The objective of this study is to investigate how the intraocular pressure (IOP)-lowering effect of the L-PPDS is altered by adjunctive Xalatan therapy.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Diagnosed with bilateral Open-Angle Glaucoma or Ocular Hypertension
* Currently on prostaglandin therapy

Exclusion Criteria:

* Uncontrolled medical conditions
* Subjects who wear contact lenses
* Subjects requiring chronic topical artificial tears, lubricants, and /or - requiring any other chronic topical medications
Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041)

The purpose of this study is to assess whether timely feedback to providers on patient experiences with delayed chemotherapy induced nausea and vomiting (CINV) lead to differences in patient outcomes for subsequent cycles.


Eligibility Criteria:
Inclusion Criteria:

* Highly or moderately emetogenic chemotherapy planned for at least 2 cycles

Exclusion Criteria:

* Concurrent other anti-cancer therapy (e.g. radiation, hormone, etc.); vomiting during the 24 hours prior to first chemotherapy cycle; having a disease/condition or taking medication that may cause emesis
A Trial of Evonail® Solution for Prevention or Treatment of Onycholysis

This study is a prospective randomized controlled study of EVONAIL® solution for prevention or treatment of onycholysis in patients with breast cancer receiving docetaxel chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with breast cancer receiving adjuvant/neoadjuvant docetaxel chemotherapy

Exclusion Criteria:

* Patients with breast cancer receiving palliative docetaxel chemotherapy
* Patients having onycholysis before docetaxel treatment
A Combination Study to Determine the Safety and Efficacy of Panzem NCD With Avastin in Metastatic Carcinoid Tumors

This single center, open-label study will evaluate the safety and efficacy of Panzem (2-methoxyestradiol, 2ME2) Nanocrystal Dispersion (NCD) administered orally with recombinant human monoclonal antibody against vascular endothelial growth factor (bevacizumab) administered intravenously, in patients with locally advanced or metastatic carcinoid tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented locally unresectable or metastatic carcinoid neuroendocrine tumor
* Measurable disease, according to RECIST, with at least one lesion that is unidimensionally measurable by conventional techniques to be greater than or equal to 2 cm in diameter, or by spiral CT to be greater than or equal to 1 cm in diameter
* 18 years or older

Laboratory data to include (next 7 bullet points):

* Aspartate aminotransferase(AST)and alanine aminotransferase (ALT)less than 2.5 times the upper limit of normal (less than 5 times upper limit of normal if liver metastasis present)
* Total bilirubin less than or equal to 2 mg/dL
* Serum creatinine less than or equal to 1.5 mg/dL
* Total white blood cell count greater than 3,500/mm3
* Absolute neutrophil count greater than or equal to 1,500/mm3
* International normalized ratio less then or equal to 1.5
* Platelets greater than or equal to 100,000/mm3
* Agree to use effective contraceptive methods
* Have an ECOG performance status of less than 2
* Life expectancy of greater than 12 weeks
* Ability to understand the requirements of the study, have provided written consent, and agree to abibe by the study restrictions

Exclusion Criteria:

* Pregnant or nursing, or refusal to use appropriate birth control
* An active infection
* Have a history of myocardial infarction or angina pectoris/angina equivalent in the last 12 months (the patient may be on antianginal medications if the symptoms can be fully controlled), or have uncontrolled congestive heart failure
* Have apparent central nervous system metastasis or carcinomatous meningitis
* Have had any active cancer in addition to the carcinoid tumor within the last 5 years, with the exception of superficial skin cancer
* Be receiving concurrent treatment with therapeutic doses of any anticoagulant including all forms of heparin and Coumadin
* Have current or a history of severe bleeding
* Uncontrolled / severe hypertension
* Previous history of nephrotic syndrome
* Urine protein: creatinine ratio greater than or equal to 1.0 at screening
* Have received radiotherapy or chemotherapy within the previous 4 weeks
* Participated in any clinical trial involving conventional or investigational drugs or devices within the previous 4 weeks
* Have had major surgery within 4 weeks or plan to undergo elective surgery during treatment
* Additional uncontrolled serious medical condition or psychiatric illness
* Have any condition that is likely to interfere with regular follow-up
Evaluation of Safety and Efficacy of Two Ticagrelor-based De-escalation Antiplatelet Strategies in Acute Coronary Syndrome

The ELECTRA-SIRIO 2 study is a randomized, multicenter, double-blind, investigator-initiated clinical trial aimed to evaluate safety and efficacy of two ticagrelor-based de-escalation antiplatelet strategies in patients with acute coronary syndrome (ACS). During the hospitalization due to ACS, participants will be randomized in a 1:1:1 ratio into one of three arms: low-dose ticagrelor with aspirin (LDTA), low-dose ticagrelor with placebo (LDTP), and standard-dose ticagrelor with aspirin (SDTA), the latter being the control arm. Up to day 30, all enrolled patients will receive standard-dose ticagrelor (2x90mg) + aspirin (1x100mg). Starting from day 31 LDTA and LDTP patients will receive low-dose ticagrelor (2x60mg) + aspirin (1x100mg), SDTA - continuation of previous treatment. Starting from day 91 LDTP patients will receive low-dose ticagrelor (2x60mg) + placebo, SDTA and LDTA - continuation of previous treatment. The aim of the study is to evaluate the influence of ticagrelor maintenance dose reduction from 2x90mg to 2x60mg with or without continuation of aspirin versus dual antiplatelet therapy with standard dose ticagrelor in reducing clinically relevant bleeding and maintaining anti-ischemic efficacy in ACS patients.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of STEMI or NSTEMI or unstable angina
* for patients with STEMI, the following three inclusion criteria will have to be met: 1) new ST-elevation at the J-point in two contiguous leads with the cut-point ≥1 mm in all leads other than leads V2-V3, where the following cut-points apply: ≥2mm in men ≥40 years; ≥2.5 mm in men \<40 years, or ≥1.5 mm in women regardless of age; or a new left bundle-branch block 2) the intention to perform primary PCI 3) detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit
* for patients with NSTEMI or unstable angina, at least two of the following three criteria will have to be met:

  1. symptoms indicating myocardial ischaemia
  2. ST-segment changes on electrocardiography indicating myocardial ischaemia
  3. detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit in addition to at least one of the following:

  <!-- -->

  1. ≥60 years of age;
  2. previous MI or coronary artery by-pass grafting;
  3. ≥50% stenosis in ≥2 coronary arteries;
  4. previous ischaemic stroke or transient ischaemic attack;
  5. ≥50% carotid stenosis or cerebral revascularisation;
  6. diabetes mellitus;
  7. peripheral artery disease;
  8. chronic kidney disease with glomerular filtration rate \<60 mL/min.

Exclusion Criteria:

* contraindications to ticagrelor or/and aspirin
* indications for oral anticoagulation therapy
* second or third grade atrio-ventricular block
* previous stent thrombosis on treatment with ticagrelor
* end stage kidney disease with glomerular filtration rate \<15 mL/min or on haemodialysis
* administration of prasugrel during the index event
* pregnancy
Multicentre Retrospective Study to Understand Anti-thrombotic Treatment Patterns and Outcomes of Acute Coronary Syndrome (ACS) Patients

TRACE is a Multicentre Retrospective Study planned to gather follow up data for a period of 1 year in order to understand anti-thrombotic management patterns and outcomes of Acute Coronary Syndrome patients in India.

This retrospective study is designed to provide a rapid and quick analysis of the existing database of ACS patients. So as to ensure quality check in the study, a pilot study will be conducted with around 500 patients at 10 centres across India and based on the meaningful results of the pilot study, full retrospective multi-centric study will be initiated at various selected centres across India. This study will use available registry data from a defined time period of Jan 2007-Dec 2009.


Eligibility Criteria:
Inclusion Criteria:

* Patients of the age of 18 years or older and hospitalized for ACS within the previous 3 years.
* Diagnosis of STEMI, NSTEMI or UA using Standard and Universal Definition of Myocardial Infarction

Exclusion Criteria:

* UA, STEMI and NSTEMI precipitated by or as a complication of surgery, trauma, or GI bleeding or post-PCI.
* UA, STEMI and NSTEMI occurring in patients already hospitalized for other reasons
Effect of Oasis® Wound Matrix on Stage III and IV Trunk Pressure Wounds Treated With Negative Pressure Wound Therapy

This study evaluates the therapeutic effect of Oasis® Matrix along with Negative Pressure Wound Therapy (NPWT) on pressure wounds. Either Oasis or standard foam will be applied to the wound prior to activating the NPWT.

In this study, patients being treated with Negative Pressure Wound Therapy (NPWT) will be randomized to receive either:

1. Oasis® matrix, applied to the wound, along with standard of care including NPWT OR
2. Standard foam, applied to the wound prior to activation of NPWT, which is standard care.

Wounds will be examined weekly for up to 12 weeks. At weeks 4, 8, and 12, the NPWT evacuation canister will be collected for specimen analysis.

The aim of this study is to determine the therapeutic effect of using Oasis® Wound Matrix with NPWT. Outcomes include: a) closure rate of non-healing wounds, and b) levels of growth factors and interleukins in fluid evacuated from the wound.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-89 who exhibit stage III or IV trunk pressure wounds with no signs of infection.
* HbA1C \< 8 (if patient is diabetic)
* Adequate nutrition including albumin above 2.0 and prealbumin above 15.

Exclusion Criteria:

* Wounds that cannot have a NPWT device properly applied due to location (too close to anus), diarrhea, periwound skin issues.
* Patients with Infected wounds.
Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis

OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes.

METHODS:

Design: Retrospective cohort study. Setting: Academic Level I Trauma Center. Patient Selection Criteria: Included were patients with femoral neck fractures treated with DHS or cannulated screws, with follow-up data available.

Outcome Measures and Comparisons: Main outcomes were femoral neck shortening, incidence of AVN, and Harris Hip Score (HHS) for functional assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 80 years and younger
* Minimum of 2 years' follow-up
* Diagnosed with a femoral neck fracture
* Treated with either cannulated screws or a Dynamic Hip Screw (DHS).

Exclusion Criteria:

* Patients with multiple fractures in the same extremity
* Presence of malignancy
* Diagnosis of osteoporosis
* Systemic inflammatory or metabolic diseases
* Infection or malignancy in the hip joint
* Insufficient medical records
* Patients unwilling to participate in the study.
Valproic Acid With Methylprenisonlone for the Treatment of Acute GVHD

aGVHD remains as complication in patients after allogeneic stem cell transplantation. Methylprednisolone at 1\~2mg/kg is considered as standard first-line treatment. In recent lab study, we demonstrated that valproic acid (VPA) as histone deacetylase inhibitor can inhibit CD4+ Th1 and Th17 cells and control the aGVDH in mice model while preserve the GVL effects. In this study, we tested the hypothesis that adding VPA to standard dose steroid treatment may improve the outcome of aGVHD.

To evaluate the complete response rate of VPA+Methylpednisolone in patients with Grade II-IV aGVHD after allogenetic stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Grade II-IV aGVHD
* No previous history of allergy to valproic acid
* No active and severe infection

Exclusion Criteria:

* Inclusion in other clinical trial
* GVHD Prophylaxis with valproic acid
* severe organ dysfunction: heart, lung, liver and kidney
Neramexane for Tinnitus

Tinnitus is commonly referred to as "ringing of the ears" - the perception of sounds in the absence of an external source of acoustic signals. Tinnitus may represent a severe disease and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing loss. One hypothesis is that tinnitus is caused by an increased activity of NMDA glutamate and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous system. Neramexane may alleviate tinnitus symptoms due to its NMDA and alpha9/alpha10 nACh receptor blocking activity. The purpose of this study is to assess the safety and efficacy of Neramexane compared with placebo in patients with subjective tinnitus.


Eligibility Criteria:
Inclusion Criteria:

* main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus

Exclusion Criteria:

* main exclusion criterion: intermittent or pulsatile tinnitus
Changes in Cardiac Deformation Following Physiologic Alterations and Inotropic Support.

The investigators want to compare the effects of two drugs, levosimendan and milrinone, on cardiac muscle, both in terms of contractility and relaxation. Half of the participants will be randomized to each drug. The effects will be measured through echocardiographic deformation analyses.

Since deformation analyses could be dependent on different loading conditions of the heart, a second purpose of the study is to investigate the changes on deformation parameters after applied changes in preload and afterload, but also heart rate.

Aortic stenosis is associated with myocardial hypertrophy and diastolic dysfunction. In patients undergoing open aortic valve replacement surgery due to stenosis, the investigators want to compare the effect on myocardial relaxation between two commonly used drugs, levosimendan and milrinone, using catheter-based measurements in combination with echocardiographic evaluation.

Standard anaesthesia and surgical care for these patients is performed. After surgery is completed and the participant is transferred to the intensive care unit, the studies are performed during general anaesthesia and the participants still connected to a respirator with controlled ventilation.

Echocardiographic data will be collected simultaneously with hemodynamic parameters - first at two control measurements, then after each of two different doses of the drug. Preload, afterload and heart rate will be kept stable during this intervention. The echocardiographic data is later analyzed offline for strain and strain rate.

To further investigate the dependency of strain and strain rate on changes in preload, afterload, and heart rate, these variables are consecutively changed prior to drug administration. For this purpose, all patients first have their baseline data recorded, thereafter are paced at two different rates, then preload and afterload is altered by passive leg elevation and phenylephrine, respectively. Hemodynamic and echocardiographic data are collected simultaneously at baseline and after each intervention. Before administration of the drugs, baseline conditions are restored.

Eligibility Criteria:
Inclusion Criteria:

* Subject has aortic valve stenosis
* Subject is scheduled for open heart aortic valve replacement with or without simultaneous coronary artery bypass grafting

Exclusion Criteria:

* Less than normal systolic function, defined as ejection fraction less than 0,5
* Non-sinus rhythm
* Any major surgical complication
* Problems understanding the informed consent
French Adult Primary Immune Thrombocytopenia

Primary immune thrombocytopenia (ITP) is rare. First-line treatment is corticotherapy. Then, several second-line treatments (SLT) are available: splenectomy, off-label rituximab and thrombopoietin-receptor agonists since 2009. The compared efficacy and safety on clinical events in the long-term are unknown. The main objective of the FAITH study is to build the cohort of all treated adult persistent (≥3 months) primary ITP patients in France, to assess the benefit-to-risk ratio of SLT in real-life practice. Data source is the database of French Health Insurance System (SNIIRAM) which covers the entire French population. It collects demographic, chronic disease, hospitalization and drug dispensing data. All patients with ITP were extracted from 2009 to 2012, and then every year for 10 years. The investigator will build the cohort from raw data. Outcomes (death, hospitalization, drug dispensing) will be compared according to SLT, with controls from the general population and untreated patients.


Eligibility Criteria:
Inclusion Criteria:

* Incident case of immune thrombocytopenia or control patient

Exclusion Criteria:

* Patient not registered in the database between 2009 and 2012
Severe Legionellosis Cases Admitted to Grenoble University Hospital, 2006-2011.

The study aimed at further describing the epidemiological, clinical, diagnostic and prognostic features in legionellosis cases admitted to Grenoble University Hospital during the 2006-2011period. The investigators also tested lower respiratory samples collected from these patients during their routine medical care, using a number of molecular tools allowing determination of the involved Legionella species, the bacterial load, and the presence of antibiotic resistant mutants. Our primary goal was to define biological markers that could predict severity and outcome of infection in legionellosis cases requiring hospitalization.

Patients admitted to Grenoble University Hospital between 2006 and 2011 for severe legionellosis were retrospectively included in the study.

Clinical, epidemiological, diagnostic and prognostic data of these patients were recorded retrospectively.

Lower respiratory samples collected from these patients on a routine basis for microbiological analysis, especially Legionella culture, were tested using traditional microbiological methods. The remaining part of these samples was stored at -80°C fur further molecular analyses.

The molecular tools developed by our bacteriology laboratory included the following: a real-time polymerase chain reaction (qPCR) test allowing detection and differentiation of L. pneumophila and other Legionella species; a qPCR test allowing determination of the Legionella DNA load in lower respiratory samples; a qPCR allowing detection of gyrA (the gene encoding subunit A of DNA gyrase) mutations that the investigators previously determined to be correlated with fluoroquinolones resistance in L. pneumophila; a high-throughput sequencing approach allowing confirmation of gyrA mutations and determination of the percentage of mutated alleles.

The microbiological data, especially those obtained with the developped molecular tools, were tentatively correlated with the severity and outcome of infection in our patients' cohort.

Eligibility Criteria:
Inclusion Criteria:

* age higher than 18 years
* proven legionellosis case (positive culture and/or PCR and/or urinary antigen test)
* severe case requiring hospitalization

Exclusion Criteria:

* age under 18 years
* pregnant women
Impact of the Contamination Mode on the Clinical Evolution During Pseudomonas Aeruginosa Ventilator Acquired Pneumonia (PYO GEN)

Pseudomonas aeruginosa is the main pathogen of nosocomial respiratory infections. Its increasing resistance to antibiotics requires the development of new strategies for prevention and control, demanding a better understanding of the modes of transmission and evolutionary dynamics of this bacteria. In patients under invasive mechanical ventilation, the main mode of contamination by Pseudomonas remains debated, with 3 modes of contamination (endogenous, crossed transmission between patients, or environmental origin) of varying importance, mainly depending on the endemic situation of the place of study.

The emergence of new genotyping technologies (DiversiLab) can now facilitate studies of molecular epidemiology. Thanks to the multidisciplinary collaboration and innovative techniques, the investigators wish to study the impact of the mode of contamination on the outcome of ICU patients, intubated and ventilated for more than 72 hours.

The presence of environmental reservoirs can cause infections and multidrug-resistant P. aeruginosa colonization with P. aeruginosa is itself a prognostic factor, but the impact of the route of infection on the evolution of the history and future of the infectious patient is not established.

A second factor that may influence the evolution infectious is the degree of genetic heterogeneity of the bacterial population. Multiple exposure pathways could also influence the genetic diversity.

Eligibility Criteria:
Inclusion Criteria:

* Patients\> 18 years
* hospitalized in the intensive care unit
* with more than 72 hours of mechanical ventilation
* Presenting a positive bacteriological sample P. aeruginosa.

Exclusion Criteria:

* Minors.
* Pregnant or lactating women.
* Patients under guardianship, under judiciary placement, or hospitalized without their consent.
* Patients not affiliated to a social security scheme.
* Long-term corticosteroid therapy (\> 2mg/kg or\> 1 month before the onset of established infection suspected)
* Ongoing chemotherapy, AIDS, transplant patient under immunosuppressive drugs.
* Bedridden patient or therapeutic decision at ICU arrival