cyrilzakka/clinical-trials huggingface dataset:
Clinical Trials of Adjuvant Androgen Deprivation in Localized Prostate Cancer

The present study is a phase III randomized and multicentric trial evaluating the potential additional impact effect of two years adjuvant androgen deprivation when combined with neoadjuvant (4 months) and high-dose (76 Gy) conformal radiotherapy in moderate high-risk prostate cancer patients. Stratification will be performed by prognostic factors and by participating institution.


Eligibility Criteria:
Inclusion Criteria:

* Histological proven adenocarcinoma of the prostate
* Stage: cT1c-3b N0M0 according to American Joint Committee on Cancer (AJCC) Tumor Node Metastasis (TNM)
* Prostatic Specific Antigen (PSA)\<100 ng/ml
* Intermediate (T1-T2 with Gleason Score \[GS\] 7 and/or PSA 10-20)
* High risk (T3 and/or GS 8-10 and/or PSA \> 20)
* Karnofsky Index (KI) performance status ≥70%
* Written informed consent

Exclusion Criteria:

* T4 N1 M1,
* Previous surgical treatment (prostatectomy or cryosurgery)
* Neoadjuvant hormonal treatment \> 3 months.
* History of pelvic radiotherapy (RT)
* Contraindications for radiotherapy
* Concomitant use of chemotherapy
* Serious psychiatric or medical condition
* Current synchronic malignancies
Screening for Autism in 9-Month-Olds by Measuring Social Visual Engagement

The goal of this project is to measure the clinical utility of an objective and quantitative eye-tracking assay collected on a standalone, mobile investigational device to accurately screen 9-month-old infants for autism spectrum disorder and other actionable delays.

The purpose of this study is to see if measuring how infants look at social information can be used as a screening tool to identify developmental delays or vulnerabilities in infants as young as 9 months of age. What the 9-month-old infant looks at will be measured with eye-tracking technology, which uses a video camera to safely measure the child's eye movements while the child watches video scenes of other children at play. Parents/caregivers will be asked if they would like to participate during their child's 9-month well-baby visit at their pediatrician's office. If they agree to participate, the child will have their first study visit at this time. Children will undergo an eye-tracking session to measure social looking. Parents/caregivers will also complete forms and questionnaires about their child's health and development. The forms will be emailed, to be completed when the child is approximately 9, 12, 15, 18, 21, and 24 months old.

If a child shows signs of developmental delay (DD) or autism spectrum disorder (ASD), the child will be asked to participate in a comprehensive developmental and diagnostic assessment in-person with expert clinicians when the child is between 18-26 months old, to determine the child's strengths and any vulnerabilities, and to recommend any support or treatment if needed.

If the child does not show signs of developmental delay and/or autism, the investigators may still invite the child for an in-person assessment with expert clinicians when the child is between 18-26 months old. Approximately 10% of children who do not show any signs of developmental delay and/or autism will be randomly selected for an in-person assessment. At the end of the assessment, parents/caregivers will be provided feedback on their child's strengths and any vulnerabilities and, if necessary, a report will be written to help them access services for their child.

Eligibility Criteria:
Inclusion Criteria:

* Infants between the chronological ages of 8-10 months;
* Infants must be generally healthy with no acute illnesses likely to prevent successful or valid data collection (e.g., current vomiting, high fever, conjunctivitis affecting vision);
* participants' parents/caregivers must be able to understand and voluntarily provide written informed consent.

Exclusion Criteria:

- Children will be excluded if they have signs of acute illness likely to prevent successful or valid data collection (e.g., conjunctivitis affecting vision, current vomiting, or high fever).
Mitochondrial Capacity in Pregnant Women

This Pilot \& Feasibility study will test the hypothesis that pregnant women who are more active will have better functioning mitochondria in vivo (higher ATPmax, via 31P-MRS), which will be positively related to maternal and infant mitochondrial function in vitro (higher oxygen consumption rates in primary myotubes and umbilical cord derived mesenchymal stem cells, respectively). Twenty pregnant women (10 active and 10 sedentary) will be recruited in the first trimester of pregnancy determined from self-reported physical activity and assessment by activity monitors. Placental biospecimens will be collected during delivery for other molecular mitochondrial analyses.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant female
* BMI between 18.5 kg/m2 and 30.0 kg/m2 prior to the current pregnancy (determined by self report and confirmation of pregravid BMI of the index pregnancy from the prenatal record)
* Medically cleared for participation in the study by primary care obstetrician or midwife
* Medically cleared for participation by the Medical Investigator
* Medical record release (prenatal record, hospital delivery record) for study staff to access information in the medical record related to the current and if applicable, the prior pregnancy.

Exclusion Criteria:

* Risk of early delivery (eg. history of preterm birth, spontaneous abortion, evidence of gestational hypertension (SBP \>160 mmHg \& DBP \>110 mmHg) or pre-eclampsia in the current pregnancy)
* History of intrauterine growth-restriction
* Persistent second- or third-trimester bleeding
* Placenta previa after 26 weeks gestation
* Incompetent cervix or cerclage
* Severe anemia
* High-order pregnancy (e.g. triplets)
* Family history of diabetes
* Heart or lung disease
* HIV or AIDS (self-reported)
* Individuals with contraindication to magnetic resonance spectroscopy such as having magnetic metallic objects in their body
* Unwillingness for placental biospecimens to be collected at delivery
SGLT2i As Anti Arrhythmic Therapy to Prevent Sudden Cardiac Deaths.

Failing heart negative remodeling alterations might provide electrical heterogeneity and cardiac remodeling, thus potentially contributing to the occurrence of ventricular arrhythmia and subsequent sudden cardiac death (SCD). In this study we have prospectively investigated whether sodium glucose transporte-2 inhibitors (SGLT2i) could modulate serum markers of heart failure (ultra sensitive Troponin , B type Natriuretic Peptide (BNP), C reactive protein (CRP), the heart rate (HR) and serum catecholamines in patients with type 2 diabetes mellitus (T2DM), and be used as predictors for the occurrence of malignant ventricular arrhythmias (VTAs) in patients who had received an Implantable Cardioverter Defibrillator (ICD) for primary prevention. In these T2DM patients with ICD we investigated the functionality of devices, the appropriate and inappropriate shocks, and the hospitalizations for heart failure and the cardiac deaths.


Eligibility Criteria:
Inclusion Criteria:

* stable heart failure; indication for a ICD and/or a CRT-d system; NYHA Class II-III; left ventricle ejection fraction \<35%; patients receiving optimal medical therapy without controindications to receive SGLT2i; diagnosis of T2DM.

Exclusion Criteria:

* NYHA Class I, and IV; co-morbidities which may limit life to \<6 months; history of cardiac surgery or intervention within the preceding 90 days; history of moderate to severe chronic obstructive pulmonary disease (COPD), defined as needing chronic oxygen therapy, or recent (within 30 days) hospitalization for COPD flare-up; pregnancy; history of primary pulmonary hypertension.
Pronator Quadratus Preservation Following Volar Plate Fixation. RCT

The purpose of this study is to determine pronator quadrutus preservation have clinical impact following volar plate fixation


Eligibility Criteria:
Inclusion Criteria:

* Fractures of distal radius with instability (Aofoundation.org)
* Age between 15-75 años
* Informed consent approval for ethical comitte

Exclusion Criteria:

* Previos surgery of the hand, wrist or forearm
* Inflammatory arthropathy
* Carpal tunel syndrome
* Sensory or mixed neuropathy
* Bilater wrist fracture
* Functional deficits of ipsilateral extremity
* Functional deficits of contralateral extremity
* Complications after surgery with motor deficit
* Disease that can evolve with neuropathy during study time
Determination of Peripheral Immune Cell Activity During Treatment With Either Surgery or Radiotherapy in Patients With Early Stage NSCLC

Rationale: An anatomical surgical resection is considered to be the standard of care in fit patients who present with early stage non-small cell lung cancer (NSCLC). However, surgery is less frequently performed in both elderly patients (aged ≥75 years), who represent the fastest-growing group of patients with stage I/II NSCLC, and in patients who have significant co-morbidity. Following the introduction of stereotactic ablative radiotherapy (SABR), an outpatient treatment that is typically delivered in between 3-8 fractions, the median survival of all elderly patients undergoing radiotherapy in The Netherlands increased by 9.3 months. Randomized trials comparing SABR and surgery have yet to be completed and results of the ongoing ACOSOG Z4032 studies will not be available in the within 5 years. A recent data retrospective study comparing both modalities has raised interesting questions about the impact of local therapy on recurrence patterns. It was found that a better loco-regional disease control rate was achieved with SABR.

Objective: To study the effect of surgery and SABR on both immunostimulatory (with primary endpoint CD8 positive cells) and immunosuppressive cells in peripheral blood in patients with early stage non-small cell lung cancer who are treated with either modality.

Study population: 40 patients with cT1-2aN0M0 either cytologically or histologically proven NSCLC.

Main study parameters/endpoints: To determine whether an increase in CD8 activity can be established after SABR in patients with early stage lung cancer and to compare this increase with that in patients undergoing a surgical intervention. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Only risks in participation are the risks with drawing blood. Subjects will not have any benefits. This pilot study will be used to generate information concerning both treatments useful for the decision to plan a future study in a larger series of patients.


Eligibility Criteria:
Inclusion Criteria:

* Cytologically or histologically proven cT1-2aN0M0 NSCLC
* Patients ≥ 18 years old
* Patients should be fit to undergo both treatments in accordance with institutional protocols

Exclusion Criteria:

* Patients with any signs of any co-existing infectious disease or immunosuppressive treatment (inhalation steroids are permitted)
* Mentally incapacitated subjects
Prevalence and Kinetics of Diaphragmatic Dysfunction in Elderly Patients With Acute Respiratory Distress

Acute respiratory distress (ARD) is one of the most frequent reasons for consultation and hospitalization in emergency medicine. The use of ultrasound methods as a diagnostic and clinical assessment tool in emergency medicine is increasingly important. As such, ultrasound is a simple, non-invasive means of assessing diaphragmatic function in the patient's bed. Several methods of ultrasound assessment of diaphragm function have been described. Among these different methods, the diaphragmatic excursion seems to have a better intra and interobserver reproducibility as well as a greater feasibility, in particular because of its speed of realization and its learning curve seeming faster in comparison with the measurement. of the thickening fraction. Measuring the diaphragmatic excursion could therefore ultimately represent a simple means of assessing respiratory function, both diagnostic and prognostic, in patients with acute respiratory distress in the emergency departments. The etiologies of acute respiratory distress in very elderly patients (i.e.\> 75 years) admitted to the emergency reception service are multiple.

To our knowledge, there is no data available in the literature on the prevalence of diaphragmatic dysfunction and its short- and long-term course in this category of patients. The main objective of this study is therefore to assess the prevalence of diaphragmatic dysfunction and its evolutionary kinetics in patients over the age of 75 admitted for acute respiratory distress in the emergency medicine department.


Eligibility Criteria:
Inclusion Criteria:

* Patient in spontaneous ventilation at the admission on emergency room
* Presence of acute respiratory distress defined by at least 1 of the following criteria:

  * Respiratory rate \> 25/min and/or clinical signs of acute respiratory distress,
  * Hypoxia defined by Sp02 \< 90 %,
  * Hypercapnia defined by PaC02 \> 45 mmHg with respiratory acidosis defined by a pH value \<7.35.
* Absence of opposition of the patient to his participation in the study and the use of his data or the trusted person if the state of the patient does not allow it.

Exclusion Criteria:

* Presence of a preexisting diaphragmatic dysfunction appearing in the history or the medical file of the patient and explored on the electro-physiological level,
* Patient with acute respiratory distress on arrival at the SAU with clinical criteria justifying immediate use of invasive mechanical ventilation and not allowing ultrasound measurements to be carried out or patient admitted to the SAU with mechanical ventilatory support from the outset,
* Poor command of the French language or state incompatible with the patient's understanding and / or informed adherence to the study protocol,
* History of surgery involving the integrity of the diaphragmatic muscle (diaphragm plication or diaphragmatic lumpectomy or placement of diaphragmatic pacemaker),
* Criteria for shock or severe hemodynamic instability,
* Intra-cranial hypertension.
Effects of Consuming Artificial Sweeteners and Sugar on Cerebral and Physiological Responses

This study aims at investigating the acute influence of artificially sweetened beverages consumption (as compared with sugar-sweetened beverages and water consumption) on brain responses to the viewing of food images, on physiological responses (gut-derived hormones and lipid metabolites) and on the food intake behavior.

This study is made on a randomized controlled crossover design including three conditions (water, sugar, artificial sweeteners). Measurements will be performed in fasting and fed conditions. The test-meal will comprise either an artificially or sugar-sweetened beverage or water (control). The spatio-temporal brain dynamics to the viewing of food pictures will be assessed by means of electroencephalography (EEG) recordings and electrical neuroimaging analyses. Venous blood and urine will be collected. Blood pressure, cardiac frequency and bio-impedance measurements will be performed. Food intake behavior will be assessed by means of questionnaires and a free-choice buffet. Each tested condition (water, sugar, artificial sweeteners) will be preceded by a run-in period during which the participants' diet will be controlled (2-day isoenergetic diet).

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Caucasian
* Right-handed
* Weak to normal physical activity (\< 3hours per week)
* Normal-weight (19\<BMI\<25 kg/m2)
* Regular consumption of sugar-sweetened beverages (\>33cl per week)

Exclusion Criteria:

* Consumption of artificially sweetened beverages exceeding 33cl per week
* Diabetes
* Cardiovascular, kidney, hepatic and/or psychological disorders
* Blood pressure at rest \> 140/90mmHg
* Body weight \< 50kg
* Hemoglobin \< 13.5g/dl
* Ferritin \< 50microg/l
* Drug consumption
* Alcohol consumption (\>10g/day)
* Smoking
* Any particular diet (e.g. vegetarianism), food allergy and/or intolerance
* Body weight gain or loss of \>3kg during the last 3 months
E. Faecalis Prevalence in Primary and Secondary Endodontic Infections: a Pre-post Microbial Analysis Following Chemo-mechanical Preparation

Post-treatment apical periodontitis is a fairly prevalent condition frequently caused by a persistent endodontic infection due to failure of the endodontic treatment. Microbial species in treated or untreated root canals were found to be different, with the former being less diverse and mainly characterized by Gram positive, facultative anaerobes bacteria than the latter. Enterococcus faecalis is the most frequently detected species in root-filled teeth in many studies (Zhang et al., 2015). In fact, E. Faecalis retains many virulence factors allowing adhesion to host cells and extracellular matrix, tissue invasion and damage through toxins release, as well as the ability to survive even in harsh environmental conditions. Further studies are needed to clarify E. faecalis prevalence among the different forms of pulpal and periapical lesions as well as its correlation with clinical symptoms.


Eligibility Criteria:
Inclusion criteria:

* between the ages of 18 and 70;
* good systemic health.
* patients in need of an endodontic treatment/retreatment

Exclusion criteria:

* taking antibiotic therapy in the previous 3 months;
* presence of communication between the canal system and the oral cavity;
* teeth that are not perfectly isolated;
* teeth with probing depth \>4 mm with positive BOP.
Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.

This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding.

This study is a Multicenter, Randomized, Parallel and Prospective study to compare Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and to investigate Prevention of gastrointestinal bleeding.

Participants are defined as persons who underwent a Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer. For 8 weeks, Participants treated as Ilaprazole 20mg or Rabeprazole 20mg once a day. After treatment, The ulcer healing rate was evaluated by Endoscopy at 4, 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 19 year old ≤ Male or female \< 85 year old
* Subject who underwent Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer
* Subject who agrees to participate and spontaneously sign the Informed consent form(ICF).

Exclusion Criteria:

* Known hypersensitivity to any component of ilaprazole
* Subjects who are taking contraindicated medications(ex. atazanavir) for experimental and concomitant drug.
* Subjects with abnormal levels in the laboratory tests

  * Total Bilirubin, Creatinine\> 1.5 times upper limit of normal
  * Alanine transaminase(ALT), Aspartate transaminase(AST), Alkaline phosphatase, Blood urea nitrogen(BUN)\> 2 times upper limit of normal
* Subjects diagnosed with other cancer within 5 years other than stomach cancer.
* Subjects with a history of Zollinger-Ellison syndrome, Barrett's esophagus, primary esophageal motility abnormality, esophageal strictures, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease
* Subjects with a history of major surgery that can affect gastric acid secretion.
* Subjects should continue taking the following medicine during the study period : anticholinergics, promoting motility agents, prostaglandin analogs, sucralfate, aspirin, steroid, NSAIDs drug
* Subjects with uncontrolled organ failure (liver dysfunction, renal dysfunction)
* Pregnant and/or lactating women
* Subjects participating in a clinical trial before another trial within 30 days
* Inconsistency judged subject by researcher
The CUSA Clarity Bone Tip Study

The aim of the Study is to investigate the clinical performance and surgeon preferences of the CUSA Clarity Bone Tip during skull base surgery with removal of bony, and other cranial calcified tissue.


Eligibility Criteria:
Inclusion Criteria:

* Subject is at least 18 years of age
* Subject requires a cranial skull base procedure involving removal of bone with ultrasonic aspirator
* Subject is an appropriate candidate to receive use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery, per the study surgeon
* Subject signed the IRB/EC-approved informed consent form demonstrating that the subject is willing and able to participate in this clinical study and to comply with all study procedures

Exclusion Criteria:

* Subject is currently pregnant or plans to become pregnant prior to the study index surgery
* Subject has any significant medical condition that in the opinion of the investigator will interfere with protocol evaluation and participation
* Subject's surgical plan includes utilizing CUSA Clarity Bone Tip for bone removal anywhere besides the cranial skull base in an open craniotomy (e.g. transsphenoidal approach or spinal procedures).
* Subject is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or ethics committee.

Intra-operative exclusion criteria :

* Surgeon does not utilize CUSA Clarity Bone Tip for cranial skull base bone removal during surgery or utilizes CUSA Clarity Bone Tip anywhere else besides the cranial skull base
Expanded Access to Avelumab for Treatment of Metastatic Merkel Cell Carcinoma (mMCC)

Expanded access to Avelumab solution for infusion will be made available for adult patients with mMCC whose disease has progressed after receiving at least one prior chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Measurable metastatic Merkel cell carcinoma according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1), has failed at least one line of adequately dosed chemotherapy in the metastatic setting and has subsequently progressed (where adequate dosing is defined as a minimum of 2 cycles)
* Not eligible for participation in any ongoing clinical trial for Merkel cell carcinoma including the Javelin Merkel 200 study (NCT02155647)
* Adequate hematological, hepatic and renal function as defined in the protocol

Exclusion Criteria:

* Brain metastases
* Prior organ transplantation, including allogeneic stem cell transplantation
* History of testing positive for human immunodeficiency virus (HIV) or known AIDS or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Concurrent, active, malignant disease (other than Merkel cell carcinoma) with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ as defined in protocol
* Previous or active autoimmune disease requiring systemic immunosuppressive therapy
* Known severe hypersensitivity reactions to monoclonal antibodies, any history of anaphylaxis, or uncontrolled asthma
* Clinically significant (that is, active) cardiovascular disease: cerebral vascular accident / stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment) unstable angina, congestive heart failure (New York Heart Association Classification Class ≥ II), or serious cardiac arrhythmia requiring medication
* Persisting toxicity related to prior therapy of Grade \>1 NCI-CTCAE v 4.03 (alopecia and sensory neuropathy Grade ≤ 2 is acceptable)
* Being treated with chronic systemic corticosteroids or other chronic therapeutic immunosuppression
* Pregnant or lactating (for women of childbearing potential)
* Not using a highly effective contraception if the risk of conception exists