cyrilzakka/clinical-trials huggingface dataset:
A Study on Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

Previous studies have shown that BRAFV600E mutant mCRC patients have a shorter survival time than BRAF wild type mCRC patients. For Chinese patients, however, it remains unclear about the BRAF gene mutation rate, diagnosis, prognosis and survival data in people with BRAFV600E mutant mCRC .

This real-world, multicenter non-interventional study (NIS) will describe the mutation rate, treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in China.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically or cytologically confirmed CRC that is metastatic and unresectable
* Presence of BRAFV600E mutation in tumor tissue, as confirmed by a local assay

Exclusion Criteria:

* patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection
Pilot Study of Hippocampal Function in Type 1 Diabetes Mellitus (T1DM)

This study is an expansion of a previous study done to determine how thinking skills relate to hypoglycemia (low blood sugar) and certain regions of the brain in children and adolescents. In this study, the investigators are testing thinking skills and measuring brain activity in adolescents with and without type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Age 13 - 18
* Right handed
* Diagnosis of Type 1 Diabetes OR normal sibling control
* If diabetic, then diagnosis for at least 2 years

Exclusion Criteria:

* Pregnant or lactating
* Chronic disease other than well-controlled asthma, or Hashimoto's thyroiditis.
* Other current serious medical illness
* Co-morbid psychiatric illness
* Co-morbid neurological illness
* Pre-maturity at birth
* Contraindication to MRI scan
* orthodontic braces.
Post-Market Clinical Follow Up of Rotarex®S Catheter

Post-Market Clinical Follow Up of the Rotarex®S Catheter

A prospective, multi-center, non-randomized, multiple cohorts, observational, post market clinical follow-up study of the Rotarex®S Catheter to evaluate the safety, technical performance and medical efficacy of the Rotarex®S Catheter as a stand-alone and adjunctive therapy for the treatment of acute, subacute and chronic occlusions and sub-occlusions of arteries outside the cardiopulmonary, coronary and cerebral circulations, in accordance with Rotarex®S Catheter intended use.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥18 years old at the time of consent.
2. Subject has provided written informed consent prior to participation in the study, understands the purpose of this study and agrees to comply with all protocol-specified examinations and follow-up appointments.
3. Female patients of childbearing potential have negative pregnancy test ≤7 days before the procedure.
4. Documented symptomatic peripheral arterial disease.
5. Acute, subacute and chronic (sub-) occlusion, with ≥ 90% stenosis in native arteries and/or stents / stent grafts and/or Bypass grafts and/or AV Fistula (Dialysis access).
6. De novo or re-occluded lesion.
7. Vessel and/or stent diameter within treatable range as per Instruction For Use.
8. Occlusion crossed intraluminally by a guidewire.

   For patients requiring lower limb intervention:
9. Patient presenting with a category from 2 to 5 according to the Rutherford classification for chronic limb ischemia or a category from I to IIb according to the Rutherford classification for acute limb ischemia.

Exclusion Criteria:

1. Life expectancy \< 2 years.
2. Pregnant or nursing a child.
3. Contraindication, intolerance, or allergy to contrast media that, in the opinion of the investigator, cannot be adequately pre-medicated.
4. Myocardial infarction within 60 days prior to index procedure.
5. History of severe trauma and/or sepsis within 60 days prior to index procedure.
6. Cerebrovascular accident (CVA) or Transient Ischemic Attack (TIA) within 60 days prior to index procedure.
7. Evidence of intracranial or gastrointestinal bleeding or intracranial aneurysm within 90 days prior to index procedure.
8. Abnormal electrocardiogram or blood test results and/or any other factor that would increase risk by participating in the study in the opinion of the investigator.
9. Target lesion not crossed with guidewire or extraluminal guidewire crossing (even if in short segments only).
10. Additional lesion that is located \>3cm away from the target lesion
11. Treatment plan of the target lesion includes laser, brachytherapy, or atherectomy other than the Rotarex®S Catheter.
12. Patient is currently participating in another investigational drug or device study that has not reached the primary endpoint.
13. Patients contraindicated for antiplatelet therapy, anticoagulants or thrombolytics.
14. Patients with uncorrected bleeding disorders.
15. Thrombophlebitis or deep vein thrombosis within the past 30 days.
Multimodal Magnetic Resonance Imaging in Evaluation of Diabetic Kidney Disease

The goal of this study is to investigate the value of noninvasive evaluation of multimodal magnetic resonance imaging in diagnosis and treatment of diabetic kidney disease (DKD). We aim to explore the feasibility of multimodal magnetic resonance imaging in the staging diagnosis of DKD, and establish a non-invasive method for evaluating the progression of DKD disease by combining imaging and biochemical indicators. Multimodal magnetic resonance examinations will be performed on diabetic patients with different stages as well as regular follow-up during treatment, in order to investigate the relationship between imaging findings and pathophysiological changes of the kidneys.

At present, the clinical diagnosis of diabetic kidney disease (DKD) relies mainly on the detection of urine microalbumin，which is influenced by many other factors. Renal biopsy is another modality to detect DKD, but it cannot be widely used in clinical practice because of its invasiveness. Thus, a reproducible and reliable noninvasive method is needed for more accurate diagnosis.

Multimodal magnetic resonance imaging, which including but not limited to magnetic resonance elastography (MRE), blood oxygen level-dependent magnetic resonance imaging (BOLD-MRI), arterial spin labeling (ASL), incoherent motion diffusion-weighted imaging (IVIM-DWI), T1mapping and T2mapping, is able to provide valuable information about subtle structural and functional changes, and has shown promising potential in the diagnosis, classification and prediction of pathological and molecular features.

In this clinical trial, multimodal magnetic resonance examinations will be performed on diabetic patients with different stages as well as regular follow-up during treatment, in order to investigate the relationship between imaging findings and pathophysiological changes of the kidneys. We aim to explore the feasibility of multimodal magnetic resonance imaging in the staging diagnosis of DKD and establish a non-invasive method for evaluating the progression of DKD disease by combining imaging and biochemical indicators, in order to provide reference for clinical medication. This research could be helpful for better understanding and management of DKD, and pave the way for more accurate diagnosis, improved clinical decision-making, personalized treatment approaches for DKD patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed diabetes
* No other diseases that affect renal function (such as gout, blood related diseases, primary hypertension, nephrotic syndrome, etc.),
* No contraindications for magnetic resonance imaging examination

Exclusion Criteria:

* Image quality does not meet the measurement requirements.
* Renal function damage caused by non-diabetes factors
* Combined with other important organ dysfunction
* Combined with malignant tumor
* Combined with other metabolic diseases anemia
User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use

User Site Testing Study to evaluate usability of the Q300™ device under "real-life conditions" in a reproductive laboratory environment use.

Testing the Usability of the Q300™ device.

Specific objectives of this evaluation are as follows:

* Confirm the comprehensiveness of the User Manual in providing adequate instructions for proper system operation and application.
* Assist in further improving the User Manual and generate input to Manufacturer on way to improve the Q300™ device.
* Demonstrate that Q300 can be used by the intended users without use errors or problems that negatively impact system use.
* Evaluate the effect of using the Q300™ on the user's (i.e. embryologist's) ability to prospectively select morphologically-compliant sperm cells.
* Assist in determining the inclusion/exclusion criteria for subsequent clinical investigations.
* Further improve the QART Feature Extraction algorithm observing general morphological phenotypes in sperm cells.
* Evaluate effect of using the Q300 on the clinical outcome

Eligibility Criteria:
Inclusion Criteria:

* Patient intended for ICSI recruited from the hospital's IVF (both male and female are considered patients in this study).
* Male, Age \>18 yrs
* Female age \< 40 yrs
* Patients signed informed consent prior study procedures.
* Fresh Oocytes
* Fresh ejaculated motile sperm and presence of motile sperm at the time of sperm selection for ICSI
* Fresh oocytes
* Non severe male factor (TMC\>1\*10\^6/mL)
* Unexplained factor infertility
* AFC \>=13mm during ovarian stimulation prior to ovulation trigger or induction#\>=5 in the cycle

Exclusion Criteria:

* Frozen spermatozoa
* Immotile sperm
* Severe Oligozoospermia (less than 1 million sperm cells after preparation).
* Spermatozoa extracted by TESA/ TESE
* Frozen oocytes
* Egg or ovulatory female factor such as low ovarian reserve (menstrual cycle, per AFC. AMH test- if performed) or non-typical eggs or eggs with severe pathology (qualitative; please find
* That the instructions for use of Q300TM have not been fully followed (poor quality of images etc...)
* Inability to reliably trace sperm-oocyte-embryo clinical outcome throughout the process.
Promoting Flu Vaccination Through a Mobile Wellness Program

The investigators design a 6-week messaging campaign aimed at promoting flu vaccination among fully insured members of a national payer that participate in a wellness program offered by the insurer through a mobile app. Outcomes measured will include uptake in flu vaccination rate as measured by the insurer and engagement with the campaign through the app.

The goal of the research is to assess the effectiveness of pervasive computing messaging in promoting preventative care treatments such as flu shots. An additional goal is that of quantifying the importance of emphasizing incentives to increase efficacy of the messages.


Eligibility Criteria:
Inclusion Criteria:

* belongs to fully insured population
* continuous health coverage between January 1, 2015 and June 1, 2016
* has downloaded and installed the wellness platform app

Exclusion Criteria:

* has declined the messaging from the platform
Study of Once Daily Elvucitabine Versus Lamivudine in Participants With a Documented M184V Mutation

Human immunodeficiency virus (HIV)-1 infected participants receiving long-term therapy with lamivudine or emtricitabine (nucleoside reverse transcriptase inhibitors \[NRTIs\]) are at risk for the development of a mutation at position M184 on the HIV reverse transcriptase gene. This mutation confers resistance to both drugs (\>100 fold increase in the concentration of drug producing 50% inhibition \[IC50\]).

In-vitro studies with elvucitabine have shown that HIV-1 isolates with the M184V mutation show only a 10-fold increase in IC50 as compared to wild type HIV-1. Alexion Pharmaceuticals Inc. intention is to demonstrate that 10 milligrams (mg) of elvucitabine, administered once per day for 14 days with continued background anti-HIV-1 medications, will demonstrate a fall in HIV-1 ribonucleic acid (RNA) plasma levels, as compared to baseline. The data from this study will guide dosing in future long-term studies in HIV-1 infected participants with the M184V mutation.

This was a Phase 2a, 14-Day randomized, double-blind, comparative viral kinetic study of10 mg elvucitabine as compared to lamivudine that was administered once daily (QD) to HIV-1 infected participants with a documented M184V variant. This study also demonstrated the antiviral activity as well as the assessment of safety of the elvucitabine therapy

Participants must be receiving a stable antiretroviral regimen (defined as no change in antiretroviral therapy for at least 4 weeks prior to randomization) that includes lamivudine or emtricitabine. At 72 hours prior to randomization, only lamivudine or emtricitabine will be stopped for washout; participants will continue to receive the other drugs in their prescribed regimen (background antiretroviral therapy) during the 72-hour washout period. Participants will then be randomized to receive blinded elvucitabine or lamivudine in a 1:1 ratio and continue to receive their prescribed background antiretroviral therapy for 14 days on an outpatient basis. Participants will be followed for an additional 14 days post-treatment for safety unless they enroll in the ACH443-018 extension study where they will continue to be treated and followed for safety.

Eligibility Criteria:
Inclusion Criteria:

* Clinically stable HIV-1 infected participants
* Ages \>18 and \<65 years
* Documented M184V mutation
* CD4 cell count \>100 cells/mL
* Plasma HIV-1 RNA levels \>5000 and \<150,000 copies/milliliter (mL)
* Currently receiving lamivudine or emtricitabine
* Other hematologic and metabolic parameters must be met.
* Provide written informed consent
* Other inclusion criteria apply.

Exclusion Criteria:

* Hepatitis B antigen positive
* HIV-1 genotype positive for more than or equal to 4 protease mutations
* HIV-1 genotype positive for more than or equal to 2 non-nucleoside reverse transcriptase inhibitor (NNRTI) mutations
* Previous therapy with cytotoxic or myelosuppressive drugs in the past 3 months
* Evidence or history of cirrhosis
* Women who are pregnant or breast feeding
* Other exclusion criteria apply.
Acute Mechanisms of Cervical Transcutaneous Electrical Stimulation of the Spinal Cord

The purpose of this study is to examine how delivery of subthreshold electrical stimulation of the spinal cord alters the excitability of neural pathways and consequently movement performance in healthy and spinal cord injured individuals. Specifically, we assess how stimulation parameters such as electrode configurations and stimulation frequency affect spinal excitability, corticospinal excitability, intracortical excitability, motor unit properties and force production. This study is not an intervention study, but a mechanistic study trying to shed light on how this novel neuromodulatory technique acutely affects the central nervous system.


Eligibility Criteria:
Inclusion Criteria:

* cervical level injury (C5 to C7)
* at least 1 year post-injury

Exclusion Criteria:

* individuals with damage to the nervous system other than to the spinal cord
* pregnant women (effects of stimulation on the fetus are unknown).

Transcranial magnetic stimulation-specific exclusion criteria:

* participants with active or inactive implants including cardiac pacemakers, implantable defibrillators, ocular implants, deep brain stimulators, vagus nerve stimulator, and implanted medication pumps
* participants with conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head
* participants with a history of seizures or epilepsy
* participants taking any medication which may reduce seizure threshold
Outcomes of 20 and 23-gauge Combined Transconjunctival Pars Plana Vitrectomy

In a retrospective study, a combined 20 and 23-gauge pars plana vitrectomy procedure was performed in 21 eyes for various indications and proposed as a transition procedure to 23-gauge transconjunctival vitrectomy. Through use of combination of procedures postoperative complications, surgical trauma and healing time was decreased; operating time was reduced; costs were decreased.


Eligibility Criteria:
Inclusion Criteria:

* eyes requiring pars plana vitrectomy for various indications: such as dropped lens, intraocular blood, retinal detachments...etc.

Exclusion Criteria:

* patients who did not observed periodically during postoperative period.
Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.

A multicentre, matched-pair, cluster randomised controlled superiority trial to investigate the effect of a proactive basal bolus insulin regimen compared to the reactive sliding scale insulin regimen, targeting a glucose level of 3.9-10.0 mmol/L, to reduce the number of surgical site infections within the first 30 days postoperatively in adult patients with diabetes mellitus type 2.

People with type 2 diabetes mellitus (PWT2D) are at increased risk of postoperative complications, especially surgical site infections (SSI).

The aim of this study to reduce SSI in PWT2D by implementing a proactive basal-bolus insulin regimen, compared to the reactive sliding scale regimen.

Adult patients with type 2 diabetes will be included in this multi-centre study.

Participants will receive a blind CGM, i.e. glucose data are masked for the participants and study team, from admission to the ward until discharge from the hospital. In addition, all participants are asked to complete several questionnaires 30 days after surgery.

Both regimens are currently used in clinical practice. Therefore, there is no additional trial-related burden depending on the intervention group allocation.

Participants will be monitored intensively and insulin dosage will be adjusted adequately to the measured glucose values by the treatment team.

The sample size is based on the SSI incidence rates. Wards are matched into pairs with comparable baseline incidence rates and in each pair, one ward will be randomly assigned to the intervention group; the other serves as the control. 18 wards from 8 participating centres are planned to be recruited, this translates to 9x2x56=1008 evaluable participants.

Keywords:

Diabetes mellitus, basal bolus, sliding scale, insulin regimen, surgical site infections

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 or older
* Diagnosed with type 2 diabetes mellitus
* Undergoing gastointestinal or vascular surgery
* Admitted to one of the participating surgical wards
* Expected duration of stay at least one overnight stay
* Willing and able to provide informed consent

Exclusion Criteria:

* Diagnosed with type 1 diabetes mellitus
* Female of child-bearing potential who is pregnant or breastfeeding.
* Undergoing complete pancreatectomy
* Undergoing bariatric surgery
* Patients using a continuous insulin pump at home
* Patients undergoing a necrotectomy/wound debridement from a pre-existent wound.
Treatment of Graft Failure After Hematopoietic Stem Cell Transplantation

This is a guideline for the treatment of graft failure after hematopoietic stem cell transplant (HSCT). This regimen, consisting of cyclophosphamide and fludarabine with low dose total body irradiation (TBI) is designed to promote donor engraftment by day 42 after initial graft failure.

The graft will consist of bone marrow or G-CSF mobilized peripheral blood from a haploidentical related donor. The source of stem cells will be determined by the transplant team based on factors such as patient's age, medical history, donor availability and will be according to the current University of Minnesota Blood and Marrow Transplantation Program selection guidelines.


Eligibility Criteria:
Inclusion Criteria:

* Patients with primary or secondary graft failure, as defined below, may receive a second transplant:

  * Primary graft failure is defined as not achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42 following the first transplant.
  * Secondary graft failure is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive days by day 35 - 42, but subsequently drops below 0.5x10\^9/L without recovery.
  * Loss of chimerism is defined as achieving an ANC ≥0.5x10\^9/L for three consecutive, but with less than 10% CD15+ donor cells in the marrow or peripheral blood.
* Recipients should have acceptable organ function defined as:

  * Renal: creatinine \< 2.0 (adults) and creatinine clearance \> 30. For creatinine clearance \< 70, consultation with a BMT pharmacist is necessary for chemotherapy dose adjustments.
  * Hepatic: bilirubin, AST/ALT, ALP \< 10 x upper limit of normal
  * Cardiac: left ventricular ejection fraction \> 40%

Exclusion Criteria:

* Uncontrolled infection at the time of transplant.
* Patients with Fanconi Anemia or other DNA breakage syndromes.
Osteopathy and Children With Congenital Heart Disease Surgery

Osteopathic care impact on postoperative pain assessed by osteopathic session, evaluated by EVENDOL scale surgery on children with congenital heart disease

The management of pain in children after cardiac surgery is the key to ensure a better comfort and fast home return.

Aside drugs and psychology or physical therapy, no other alternative is proposed in the medico-surgical unit of pediatric cardiology at the Necker hospital.

Following a feasibility study within the department, osteopathic care showed significant pain reduction in postoperative surgery assessed through the EVENDOL scale.

The goal was mainly to improve mobility restricted areas due to the operation, and so help to reduce post-operative pain.

Investigators propose to continue the assessment of the overall osteopathic taking care of the child after heart surgery while retaining EVENDOL scale as primary endpoint. Population will include children from the age of 5 days to less than 7 years old.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 5 days to 7 years old
* Congenital heart sternotomy or thoracotomy operated
* Postoperative management at the Necker hospital in Paris, followed by Professor Damien Bonnet team
* Agreeing to participate of one of the holders of parental authority
* Oral Agreement child age
* Minimal knowledge of French language by parents
* Covered by the French social security system

Exclusion Criteria:

* Heart disease treated by interventional catheterization
* Postoperative complications requiring more than three weeks of intensive care
* Participation in an other biomedical research protocol
* Refusal or linguistic or mental disabilities or parents of the child