cyrilzakka/clinical-trials huggingface dataset:
Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging

Background:

- Non-invasive functional near infrared (fNIR) imaging techniques use infrared light to detect changes in blood volume and oxygen levels during brain activity. fNIR is being studied as a possible way to examine the brain activity of individuals who are unable to undergo standard brain function imaging techniques (such as functional magnetic resonance imaging, or fMRI). For instance, war veterans who have iron shrapnel in the body are not able to have fMRI scans, and very young children or children with autism and related disorders are often not able or willing to cooperate long enough in the MRI environment to allow full imaging studies to take place. Researchers are interested in comparing the results of fNIR and fMRI performed on healthy volunteers to determine if fNIR produces similarly accurate results.

Objectives:

- To examine the capabilities of non-invasive functional near infrared imaging techniques on healthy volunteers and compare the results with the existing outcomes of functional magnetic resonance imaging.

Eligibility:

- Healthy volunteers at least 18 years of age.

Design:

* Participants will have one study visit. Depending on the complexity of the task, the whole exam will take between 5 minutes and 1 hour to perform.
* Participants will be asked to sit as still as possible while wearing a headband that includes light sources and detectors (the fNIR device).
* Participants will be asked to perform a set of tasks (e.g., reading sentences or counting numbers in one s head). Data will be collected during these experiments.

Objective: to a) cross-validate our near infrared spectroscopy (NIRS) imaging system with existing functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) data, and b) to investigate any significant technical issues associated with optode placement and motion artifacts, and to explore techniques that will potentially improve the feasibility and reliability of the system according to the needs of the population for whom existing imaging systems are unsuitable.

Study population: 250 healthy volunteers

Design: The study will look for correlations between NIRS signal changes in healthy subjects when performing functional tasks, and existing fMRI data.

Outcome Measures: graded changes in blood flow and oxygen, measured with NIRS, in response to different functional tasks.

Eligibility Criteria:
* INCLUSION CRITERIA:

Age 18 years or greater.

EXCLUSION CRITERIA:

* Healthy volunteers with any skin disease that, in the opinion of the investigator, would interfere with the study measurements.
* Healthy volunteers with any past or present vascular disease.
* Known adverse reaction to latex.
* Any medical condition that, in the opinion of the Principal Investigator would preclude the inclusion of a patient onto this research study.
* Unable or unwilling to give informed consent.
Saizen® E-Device User Trial

The aim of the study is to evaluate the E-Device performances and handling on the use in common practice, by collecting the impressions of patients, nurses and the investigator on the graphic interface, the instructions manual, the E-Device training and the material itself.


Eligibility Criteria:
Inclusion Criteria:

1. Patients naïve to, or experienced with, Saizen® with growth disorders in registered indications (GHD, Turner's Syndrome, Chronic Renal Failure, patient born Small Gestational Age \[SGA\] according to the local SmPC)
2. Written informed consent must be obtained from the parent(s)/legal guardian(s) at the beginning of the study. Children able to understand the trial should personally sign and date the written informed consent

Exclusion Criteria:

1. Known hypersensitivity to somatropin or any of the excipients
2. Epiphyseal fusion
3. Active neoplasia (either newly diagnosed or recurrent)
4. History of intracranial hypertension with papilledema
5. Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose \> 116 mg/dL
6. Severe congenital malformations
7. Severe psychomotor retardation
8. Known hepatic disease as defined by elevated liver enzymes or total bilirubin (x 2 N)
9. Current congestive heart failure, untreated hypertension, serious chronic oedema of any cause
10. Chronic infectious disease
11. Previous or ongoing treatment with sex steroid therapy such as estrogens and testosterone
12. Previous or ongoing treatment with any therapy that may directly influence growth, including GH, GHRF and long duration corticosteroids therapy
13. Proliferative or preproliferative diabetic retinopathy
14. Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
15. Precocious puberty
16. Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia
17. Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
18. Participation to any clinical study within the 30 days preceding study entry
19. Pregnancy
Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease

The study is proposed as a single-site randomized double-blind placebo-controlled trial requiring 4 study visits, where two of the visits are combined with their appointment for routine clinical care. The study population will consist of patients with quiescent CD and UC and IBD-unspecified recruited from the Massachusetts General Hospital Crohn's and Colitis center. All eligible subjects will have a confirmed diagnosis of CD, UC, or IBD-unspecified according to accepted clinical, endoscopic, radiologic, and histologic criteria. Eligible patients will be contacted at the time of their routinely scheduled office visit and consented for the study. Self-report and review of medical records will be used to obtain detailed information regarding their disease on an intake questionnaire completed by a research study coordinator.

The study is proposed as a 12-week double-blind randomized controlled trial of the probiotic supplement compared to placebo. We propose to examine the effect of a specific probiotic supplement on the changes in the gut microbiome, serum metabolomic profile, and fatigue symptoms in patients with quiescent IBD.

Within 2 weeks of screening, eligible patients will be invited to visit MGH for a baseline visit. The patient will receive either the probiotic supplement or placebo for 4 weeks.

The first follow up visit will be at week 4 to check for adverse events on study treatment, to check accountability of probiotics/placebo, and to complete the set of questionnaires. Also, subjects will receive probiotic/placebo samples for the remaining 8 weeks of treatment.

At week 8, subjects will receive a phone call from a study research coordinator to check in with probiotics/placebo intake for treatment compliance and accountability records, and to complete the set of questionnaires ascertaining subjective symptoms.

Last study visit will be at week 12 which is often combined with a regular office appointment. Subject will provide serum blood and stool sample, as well as complete the set of questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Confirmed CD or UC or IBD-unspecified diagnosed according to standard criteria
* Quiescent disease defined as Harvey Bradshaw index \< 4 at baseline (week 0) or SCCAI \< 2
* Persistent ongoing fatigue symptoms
* Endoscopic or radiologic remission within 12 months of screening
* Washout of non-study probiotic supplements for at least 4 weeks prior to screening.

Exclusion Criteria:

* Patients with clinical or endoscopically active inflammatory bowel disease
* Significant non-IBD comorbidity contributing to the fatigue (such as active cancer).
* Untreated severe depression or anxiety
* Known sleep disorders without adequate treatment,
* Presence of J-pouch or a stoma
* Ongoing use of other non-study probiotics
* Women who are pregnant or lactating
Stem Cell Study for Subjects With Congestive Heart Failure

The purpose of this study is to determine if cell therapy with your own cells (autologous cells) delivered with a catheter to regions of the heart with poor blood flow will be safe and if it will improve your ejection fraction and heart failure symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 21 to 80 years old (inclusive).
* Subjects with functional class (NYHA) II or III ischemic heart failure.
* Subjects who have attempted "best" cardiac medical therapy including long-acting nitrates, maximal use of beta-adrenergic blocking agents, and angiotensin-converting enzyme (ACE)inhibitors without control of symptoms.
* Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist.
* Subjects must have left ventricular ejection fraction \<40% by echocardiography.
* All subjects must have a recent coronary angiogram (within the last 6 months) to document the coronary anatomy and insure the presence of coronary disease that is not amenable to standard revascularization procedures.
* Have serum B-type Natriuretic Peptide (BNP) level \>100 pg/ml.

Exclusion Criteria:

* Myocardial infarction (Q wave or non-Q wave defined as CKMB \>3 times normal) within 30 days of treatment.
* Successful coronary revascularization procedures within 3 months of study enrollment.
* Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
* NYHA Class IV heart failure and patients with idiopathic or non-ischemic heart failure.
* History of severe aortic stenosis (aortic valve area \< 1.0 cm2) or insufficiency (\>2+); severe mitral stenosis (mitral valve area \<1.5 cm2); or severe mitral insufficiency(\>2+).
* Implantation of biventricular pacemaker within 90 days of study treatment.
* Severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (i.e. severe chronic obstructive pulmonary disease, renal failure or cancer).
Blood Sampling of Healthy Volunteers for Immunological Research

This protocol will be used to collect crucial components of the immune system from healthy volunteers for the characterization of immune cells in fresh blood. A pipeline has been set up for comprehensive immune phenotyping of both lymphoid and myeloid cells within 24 hours after blood withdrawal.

In order to properly compare the immunobiology of healthy volunteers to (advanced) cancer patients, the investigators use age-matched controls with no history of cancer and no potentially interfering medication.

Healthy volunteers will be asked to donate 5 tubes of blood

Eligibility Criteria:
Inclusion Criteria:

* Age above 35 years
* Written informed consent
* No history of cancer
* No use of systemic immunosuppressive medication (eg. corticosteroids). Local use of corticosteroids (eg. topical or inhalation) is allowed.

Exclusion Criteria:

* Fever 14 days before blood withdrawal
* Donated blood for the same program within the last 2 years
* Pregnancy
Utility of Point-of-care Device for Rapid Determination of Cogulopathy in Trauma Patients

Traumatic coagulopathy is frequent and is an independent risk factor of mortality. Its detection mainly relies upon classic biological test like the prothrombin time and the international normaliezd ratio (INR). These tests are not available at the bedside. Point of care (POC) device for INR measurement are now available like the Coaguchek, Roche, France. The aim of the present study is to test the correlation between the POC INR and the laboratory INR.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 15 y-o
* Admission for severe trauma

Exclusion Criteria:

* Patients under oral anticoagulant
Behavioral Economics and Mobility After Stroke (BE Mobile)

In this pilot, randomized controlled trial, the investigators will compare the preliminary effectiveness of a gamification with social incentives 8 week intervention to increase physical activity for adults with stroke.

In this 2 arm randomized trial, the investigators will compare the preliminary effectiveness of a social incentive-based gamification intervention to increase physical activity relative to a control arm among adults with stroke. All participants will use a Fitbit wearable device to establish a baseline step count, select a step goal increase of 33% to 50% above their baseline and then participate in an 8 week intervention. The gamification arm will be entered into a game with points and levels designed using insights from behavioral economics. They will be asked to select a social support partner who will receive weekly updates on their progress in the game.

Eligibility Criteria:
Inclusion Criteria:

* History of ischemic or hemorrhagic stroke (confirmed with ICD-10 or DRG code) at least 3 months prior to enrollment
* Ability to provide informed consent
* Life Space Assessment mobility level 3
* Ability to ambulate outside of their home (self-reported)
* Owns a smartphone or tablet compatible with required applications for the wearable tracking device
* Sufficient cognitive ability to participate (5-minute Montreal Cognitive Assessment Score ≥ 11 points)

Exclusion Criteria:

* Inability to provide informed consent, illiteracy or inability to speak, read, and write English
* Self-reported history of falls within the last 3 months
* Severe cognitive impairment (MoCA score ≤ 10 points)
* Medical condition that may limit participation in physical activity program (e.g. metastatic cancer, end-stage renal disease)
* Currently institutionalized in skilled nursing or long-term care facility
* Baseline step count \> 7500/day
* Currently receiving physical therapy services
Boosting REcanalization of Thrombectomy for Ischemic Stroke by Intra-arterial TNK (BRETIS-TNK)

Thrombolysis and endovascular thrombectomy are the most efficient treatments for acute ischemic stroke patients in time window. However, sufficient recanalization (mTICI2b-3) can 't be acquired in all patients under thrombectomy. The EXTEND-IA TNK study indicated that tenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase among patients with ischemic stroke treated within 4.5 hours after symptom onset. This study intends to explore whether a combination of thrombectomy and intra-arterial TNK administration can increase recanalization rate after the first attempt of thrombectomy device pass for ischemic Stroke.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years;
2. Patients who presented with acute ischemic stroke and a large vessel occlusion in the anterior circulation and met the criteria of mechanical thrombectomy;
3. The subtype of ischemic stroke is large-artery atherosclerosis according to TOAST classification;
4. The availability of informed consent.

Exclusion Criteria:

1. Other sub-types of ischemic stroke such as cardioembolism.
2. Hemorrhagic stroke such as cerebral hemorrhage, subarachnoid hemorrhage.
3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<100000/mm3).
4. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis.
5. Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg).
6. Patients allergic to any ingredient of drugs in our study.
7. Unsuitable for this clinical studies assessed by researcher.
Effect of Influenza Vaccination of Healthcare Workers (HCW) on the Risk of Influenza in Patients Hospitalized in Short Stays Units

Hospital acquired influenza is associated with significant morbidity and mortality in hospitalized patients notably elderly patients. Vaccination of HCW is recommended to prevent influenza transmission in healthcare setting.

Outbreaks of hospital acquired influenza were reported in stays with high vaccine coverage in patients (higher than 85%). It is necessary to underline that an adequate vaccine cover in the elderly population will not necessarily result in a total control of the incidence. Consequently, the prevention of influenza outbreaks in this vulnerable population must also include the reduction of the exposure to the influenza viruses, in particular thanks to the vaccination of HCW.

A pilote case-control study, implemented in Edouard Herriot hospital (at Lyon University hospitals), indicates that a shielding effect of more than 35% of vaccinated HCW on hospital acquired influenza among patients (Bénet et al.; BMC Infectious Diseases 2012). The results suggest a protective effect but investigations, carried out on a more important sample are needed to validate the benefit of HCW vaccination.

The aim of this prospective multicentric cohort study is to estimate incidence of influenza among hospitalized patients according to % of influenza vaccination of HCW in short stay units.


Eligibility Criteria:
Inclusion Criteria:

* All adults patients and healthcare workers of the participating units
* With Influenza Like Illness

Exclusion Criteria:

* Patients aged \< 18 years
Miniscrews as Anchorage Device for Orthodontic Treatment

The purpose of this trial is to study and compare two different anchorage techniques. Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both groups are treated with extractions of the maxillary first premolars and fixed appliance. Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B.

The hypotheses are:

* that placement of miniscrews does not cause more pain or discomfort than premolar extractions
* that molarblock provides increase of anchorage
* that miniscrews have a better anchorage capacity than molarblock
* that miniscrews are more cost-efficient than conventional anchorage techniques

Participants are recruited from the orthodontic specialist clinic in Gävle, Sweden. After informed consent participants are randomized into Group A and B. The treatment starts with extractions of the maxillary first premolars. Extractions are performed by the participants´ general practitioner. Orthodontic treatment starts after the tooth extractions.

All participants get treatment with fixed appliance according to the straight wire concept (3M Victory brackets, .022 slot size, McLaughlin-Bennet-Trevesi prescription). The recommended wire sequence is: .016 Heat Activated Nickel Titanium, .019x.025 Heat Activated Nickel Titanium, .019x.025 Stainless Steel. Treatment time is about two years.

The following measurements are taken at:

T0 (Before treatment start): Study models, baseline questionnaire,

T1 (after tooth extractions, before the orthodontic treatment): Study models, cephalographic x-ray, questionnaire at the evening after tooth extractions, questionnaire one week after tooth extractions.

T2 (After miniscrew placement (Group A), Before space closure): Study models, cephalographic x-ray, questionnaire at the evening after miniscrew placement, questionnaire one week after miniscrew placement.

T3 (After space closure and miniscrew removal): Study models, cephalographic x-ray, questionnaire after screw removal

Eligibility Criteria:
Inclusion Criteria:

* Adolescents in need of orthodontic treatment with fixed appliance including extractions of the maxillary first premolars
* Need for Anchorage reinforcement
* Permanent dentition including the maxillary second molars in occlusion (DS4M2 according to Björk)
* Regular dental care in Sweden since the age of three.

Exclusion Criteria:

* Experience of previous orthodontic treatment
* Need for orthognathic surgery
* Need for maximum anchorage.
Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer

Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rectal adenocarcinoma
* Clinical staged T3/4 or any node-positive disease
* Age of 18-75 years
* Karnofsky Performance Status \> 80
* Adequate bone marrow reserve, renal and hepatic functions
* Without previous antitumoural chemotherapy
* No evidence of metastatic disease
* Written informed consent before randomization
* UGT1A1's genotype of 6/6 or 6/7

Exclusion Criteria:

* Clinical staged I or IV
* Age of \<18 or \>75 years
* Karnofsky Performance Status \< 80
* Previous pelvis radiotherapy
* Previous antitumoural chemotherapy
* Clinically significant internal disease
* Refuse to write informed consent before randomization
* UGT1A1's genotype of 7/7
The Labor and Delivery Teamwork Intervention Trial

A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery.

A cluster-randomized controlled trial was conducted at 7 intervention and 8 control hospitals to evaluate the effect of teamwork training on the occurrence of adverse outcomes and processes of care in labor and delivery. The intervention, called the Labor \& Delivery Team Coordination Course, was a standardized teamwork training curriculum based on crew resource management that emphasized communication and team structure. The primary outcome was the proportion of deliveries at greater than or equal to 20 weeks gestation in which one or more adverse maternal and/or neonatal outcomes occurred (Adverse Outcome Index, AOI). Additional outcomes included 11 clinical process measures.

Eligibility Criteria:
Inclusion Criteria:

* delivery at a participating hospital between 12/31/02-03/31/04
* pregnancy of 20-43 weeks gestation

Exclusion Criteria:

* delivery at less than 20 weeks or greater than 43 weeks