cyrilzakka/clinical-trials huggingface dataset:
The Vesalio NeVa Stent Retriever Study for Treatment of Large Vessel Occlusion Strokes

A prospective, open label, single-arm 90-day study designed to assess the safety, performance and efficacy of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

This is a prospective, open label, multi-center, single-arm trial designed to assess the safety, performance and efficacy of the NeVa stent retriever in the treatment of large vessel occlusion strokes. Up to 150 subjects at up 20 sites will participate in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke, and subject belongs to one of the following subgroups:

   1.1. Subject has failed IV t-PA therapy

   1.2. Subject is contraindicated for IV t-PA administration

   1.3. IV-tPA given within 3 hours of symptom onset
2. Age ≥18 and less than equal to 85
3. NIHSS score ≥ 8 and ≤ 25
4. Prestroke mRS score of ≤ 1
5. Intracranial arterial occlusion of the distal intracranial carotid artery or middle cerebral artery (M1/M2), anterior cerebral artery (ACA), posterior cerebral artery (PCA), basilar artery, or vertebral artery demonstrated with DSA.
6. Thrombectomy procedure can be initiated within 8 hours from symptom onset (defined as time last known well \[TLKW\]) and at least one NeVa pass occurring within 8 hours
7. Imaging Inclusion Criteria:

   7.1. Non-Contrast CT Selection (if CT Perfusion or MRI not utilized): ASPECTS 6-10 , or

   7.2. CT Perfusion core ≤50 cc, or

   7.3. MRI DWI core ≤50 cc
8. Subject or (legal) representative or independent physician (if approved by site's regional ethics committee, see site's informed consent form) is able and willing to give informed consent prior to the interventions.

Exclusion Criteria:

1. Pre-existing medical neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
2. Cardiopulmonary resuscitation, significant cardiac arrhythmia, evidence of ongoing myocardial infarction, concern for pre-treatment pulmonary aspiration.
3. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
4. Cerebral vasculitis
5. History of severe allergy to contrast medium.
6. Known allergy to NeVa materials (nitinol, stainless steel);
7. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis
8. Systemic infection
9. Significant mass effect with midline shift
10. Evidence of intracranial tumor (except small meningioma \[≤ 3cm\])
11. Any CT or MRI evidence of acute hemorrhage products on presentation
12. Inability to deploy NeVA device for at least one pass for any other reason
13. Life expectancy less than 6 months
14. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed.
15. Active malignancy
16. Stenosis or occlusion in a proximal vessel requiring treatment or preventing access to the thrombus.
Retrospective Evaluation of Thrombo-embolic Complication in Pelvic Fracture Surgery

Pelvic fracture are very often treated by surgery ; however there are a high level of thrombotic risk during the surgery (venous thrombo embolic events represent about 10% to 50%.

The aim of our study is to report the number of these events and identify the risk factor associated to these events regarding Greenfield Risk Assessment Profile .


Eligibility Criteria:
Inclusion Criteria:

* indication to pelvic fracture surgery
* age above 18 years

Exclusion Criteria:

* pelvic fracture without surgery indication.
Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.

The Roux-en-Y Gastric Bypass (RYGB) is the procedure of choice in morbid obesity with metabolic disorders in most of the reference centers. Recent data describes the SASI Bipartition as being as efficient on weight loss and co-morbidities as the RYGB, with the advantage of being less technically difficult and less morbidity. In order to draw definite conclusions regarding the procedure, larger series with longer follow-up are necessary.

Patients with BMI over 40, or with BMI over 35 with comorbidities are offered SASI Bipartition with 300 cm common limb or standard RYGB. Follow up is performed through visits at 3, 12, 24, 36, 48, and 60 months after surgery.

Results on weight loss, comorbidities resolution, complications, and need of supplements are registered.

Eligibility Criteria:
Inclusion Criteria:

- Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis)

Exclusion Criteria:

* Mental diseases
* Drug addiction
* Alcoholic
* Malignancy
* Pregnancy
Access BNP Clinical Enrollment Study

The goal of this study is to collect blood from subjects with a suspicion of either new onset or worsened heart failure to be used for testing studies for a new product to aid in the diagnosis of heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Adult greater than or equal to 22 years old, any gender, race, ethnicity
* Presenting with clinical suspicion of new onset heart failure or worsening symptoms suggestive of decompensated or exacerbated heart failure
* Ability to fulfill study data collection requirements (including responding to questions for the NYHA evaluation)

Exclusion Criteria:

* Individuals less than 22 years old
* Impairment in individual's capacity to give informed consent
* Dyspnea clearly not secondary to heart failure (e.g., primary lung disease or chest trauma).
* On dialysis
* On nesiritide infusion
* Subject clinical/medical history access is not available to Sponsor, delegates, and FDA or other regulatory agencies upon request.
* Active participation in a clinical study that may interfere with participation in this study (e.g., investigational drug study)
* Reason(s) determined by the Principal Investigator that would place the individual at increased risk or preclude the individual from fully complying with or completing the study.
A Trial Exploring the Opportune Administration of Nab-paclitaxel in the First Line Treatment, Camrelizumab Combined With Nab-paclitaxel and Famitinib, of TNBC.

The study is being conducted to evaluate the Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib with/without Nab-paclitaxel, of Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.


Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance Status of 0-1
* Expected lifetime of not less than three months
* Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
* Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection.
* Adequate hematologic and end-organ function, laboratory test results.
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) • Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer

Exclusion Criteria:

* Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .
* A history of bleeding, any serious bleeding events.
* Important blood vessels around tumors has been infringed and high risk of bleeding.
* Coagulant function abnormality
* artery/venous thromboembolism event
* History of autoimmune disease
* Positive test for human immunodeficiency virus
* Active hepatitis B or hepatitis C
* Uncontrolled pleural effusion and ascites • Known central nervous system (CNS) disease.
* Long-term unhealing wound or incomplete healing of fracture
* urine protein ≥2+ and 24h urine protein quantitative \> 1 g.
* Pregnancy or lactation.
* Thyroid dysfunction.
* Peripheral neuropathy grade ≥2.
* People with high blood pressure;
* A history of unstable angina;
* New diagnosis of angina pectoris.
* Myocardial infarction incident ;
Does the Presence of Cervical Facet Tropism Affect the Response to Interlaminar Epidural Steroid Injections?

Facet joints are synovial joints located on the dorsolateral side of the vertebral column. Normally, both facet joints are symmetrical. Facet tropism (FT) is defined as asymmetry between the angles of orientation of the joints, in which a facet joint in the same segment is more sagittally oriented than the other. In 1967, Farfan and Sullivan first reported that FT is a possible risk factor for the development of disk herniation. However, this is controversial as there are other views advocating that FT is not a risk factor for the development of cervical disc herniation. Further, it has been emphasized that patients with FT have a greater need for adjacent segment degeneration and new spinal surgery after spinal fusion surgeries than those without FT.

In the current literature, studies have been conducted to examine the clinical and radiological parameters that may be related to the effectiveness of cervical interlaminar epidural steroid injections (ILESI). The aim of this study was to examine the effect of the presence of FT on ILESI results in patients with cervical disc herniation-induced radicular pain.


Eligibility Criteria:
Inclusion Criteria:

aged 18-75 years, who applied to the pain medicine outpatient clinic, had axial neck and unilateral radicular extremity pain for at least 3 months, and were diagnosed with protruded disc herniation by magnetic resonance imaging were included in the study

Exclusion Criteria:

Patients with systemic inflammatory disease, bleeding diathesis,history of psychiatric illness, malignancy, contrast material or local anesthetic agent allergy, cervical spinal stenosis, history of cervical ESI, or neck surgery in the last 3 months were excluded from the study
Effect of Music in Reducing Pain and Anxiety During Hysterosalpingography in Women With Primary Infertility

This study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility

This study aims to demonstrate the value of music in lowering pain and anxiety during hysterosalpingography in women with primary infertility

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.

Exclusion Criteria:

* Using analgesics before or after the procedure, using antidepressants or sedative medications, being allergic to radio-opaque material, Current pregnancy or suspicion of pregnancy.Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.
Renal Function and Pharmacogenetics in Renal Transplant Recipients Converted From Tac BID to Tac OD

In Kidney transplant recipients Once daily Tacrolimus has the poteb\]ntial advantage of better adnerence, and perhpas improvement in reanl function compred with the twice daily tacrolimus formulation.

Our center has the largest experience in North America with once-daily tacrolimus ( advagraf) in Renal transplant recipients.

Recently we converted \~500 stable patients from the twice daily to once-daily tacrolimus.

We are interested in:

1. change in renal function
2. dose changes based on ethnic diveristy
3. dose changes based on pharmacogenetics

This will helpnus understand better ways to utilize this anti-rejection medication

The Renal transplant program at St. Michael's is one of the largest in Canada. The CNI of choice since 2000 has been tacrolimus based therapy. In 2009 our program decided to switch from bid prograf to once daily advagraf for all de-novo renal transplant recipients (RTR). Our Advagraf experience is currently the largest in North America. Because of concerns regarding generic prograf, we began a conversion of \> 600 prevalent transplant patients on bid prograf to OD advagraf in January 2012. At present this is nearly completed.

It has been recognized that dosing of tacrolimus is highly dependent on pharmacogenentic differences related to the CYP3A5 genotype. CYP3A%\*3 (nonexpressors) require significantly higher doses of tacrolimus than CYP3A5\*1 (expressers) with heterozygotes being somewhere in the middle. Our study will examine the demographics, renal function and tacrolimus dosing and Co levels, both pre and post conversion from tac BID, to tac OD in our cohort of converted patients.

Of More scientific interest, will be to retrospectively determine the CYP3A5 genotypes in recipients who required significant dose adjustments in the tac OD following conversion and compare to a matched cohort of recipients in whom no dose adjustment was needed.

The hypothesis is that recipients who require dose increase when converted from the BID to the OD formulation, will have a different CYP3A5 genotype and will tend towards CYP3A5\*3.

This will be the largest cohort to look at this question. Specifically this may lead to better dosing of tac OD, if pre-emptive genotyping prior to transplantation were to be employed.

Eligibility Criteria:
Inclusion Criteria: Renal transplamnt recipients on prograf converted to advagraf

-

Exclusion Criteria:

* none
Drug Interactions When DA-8010 is Co-administered With Paroxetine or Mirabegron in Healthy Adults

This is an open-label, 2-Part, phase 1 study to evaluate drug interactions when DA-8010 is co-administered with Paroxetine or Mirabegron in healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteer 19 years to 50 years
* Body weight in the range of 40.0 to 90.0 kg and body mass index in the range of 18 to 28kg/m2
* The subjects personally signed and dated informed consent document after informed of all patient aspects of the study, fully understanding and determined spontaneously to participate
* In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in a surgical infertility condition (both tubular obstruction, hysterectomy, bilateral tubular resection, etc.)
* The subjects who are judged appropriate to participate this clinical trial according to the physical examination, routine laboratory examination and questionnaire

Exclusion Criteria:

* Subject with serious active hepatobiliary (severe hepatic failure, etc.), renal(severe renal impairment, etc.), neurologic, immunologic, respiratory, digestive, endocrine, hematologic, cardiovascular(heart failure, Torsades de pointes, etc), urologic, psychological disease or history of such disease
* Subject with gastrointestinal disease (peptic ulcer, gastritis, gastrospasm, gastroesophageal reflux disease, Crohn's disease, etc.) or history of such disease/surgery (excluding simple appendic surgery, hernia surgery, hemorrhoid surgery)
* Subject Hypersensitive to any of the IP components or other drug components(Aspirin, Antibiotics, etc.)
* Subject who is positive for serum test results (hepatitis B test, hepatitis C test, HIV test, syphilis test)
* Subject who have history of drug/alcohol abuse or Positive in Urine drug screen test
* Subject who determined that Investigator is unfit to participate in a clinical trial due to other reasons other than the above items
Follicular Revival in Androgenic Alopecia: Evaluating Use of Micro-needling

The intent of this study is to evaluate the efficacy of microneedling through use of a professional tattoo machine in hair regrowth in patients with androgenic alopecia (AGA) over up to 6 treatments (6 months).

Proposed is an open label trial of tattoo machine microneedling in ten patients with androgenic alopecia. Ten healthy male patients older than 18 years will undergo 6 microneedling sessions. Over the course of six months, subjects will undergo up to six treatment sessions (one session every 30 day). Patients will be evaluated at 8 visits over 8 months with the first visit for screening purposes.

Eligibility Criteria:
Inclusion Criteria:

* Symmetric hair loss from AGA
* Hamilton-Norwood IIIa, III, III vertex, IV, Iva, V with low density hair coverage over majority of alopecic areas
* No or minimal scalp hair regrowth on oral and/or topical minoxidil

Exclusion Criteria:

* Any male with hair loss for other reasons
* Unilateral or asymmetric hair loss
* Hamilton-Norwood I, II, IIa, Va, IV, VII x
* Patients without hair
* Patients with the following who would make poor candidates for microneedling such as skin conditions, diabetes, or history of keloid formation
* Anything additional existing comorbidities that in the opinion of the investigator may cause unnecessary risk for the patient to participate
Neuromodulatary Efficacy of Transcranial Direct Current Stimulation in Severe Refractory Primary Dysmenorrhea

Primary Dysmenorrhea (PDM), defined as menstrual pain without discernable organic causes, is inexorably common in adolescent women, about 40-90% of women may suffer from it, and 20% of them can be severe in the context of being refractory to medication, daily function impairment, and having pain of severe degree. Novel therapeutic method is in need for pain alleviation for this particular phenotype. It has been reported that PDM females may engage motor-cortex based descending pain modulation system in our resting-state functional Magnetic Resonance Imaging (rs-fMRI) and thermal pain-activation fMRI studies. Based on the reported analgesic efficacy of transcranial Direct Current Stimulation (tDCS) on the motor cortex for various experimental painful conditions and clinical pain disorders, it is plausible that tDCS can be effective for the severe and medication-refractory PDM patients. This study aim to investigate the analgesic efficacy of tDCS in severe PDMs and to elucidate the dynamic brain neuroplasticity in the context of experimental pain after tDCS intervention. Thirty severe PDMs will be recruited and randomly allocated to either real or sham group in a triple-blind manner. Experimental pain electrical stimulation will be performed before and after the tDCS intervention. The experimental pain-evoked magnetoencephamographic (MEG) data will be correlated with behavioral and psychological measurements. This is the first study in the literature investigating the tDCS efficacy for acute pain in severe PDM. The result can promise a new possibility for clinical application.


Eligibility Criteria:
Inclusion Criteria:

* 20-35 years old PDM patients
* Right-handedness
* A regular menstrual cycle: 27-32 days
* Cramping pain during the menstrual period in the last 6 months , VAS ≧ 7
* Abstinence for daily activities due to PDM
* Need analgesic or Physical therapy despite of no prominent effect

Exclusion Criteria:

* History of head injury
* Pathological pituitary gland disease
* Organic pelvic disease, psychiatric disorder
* Pregnancy, childbirth
* A metal or pacemaker implant.
* Take hormone agents within 6 months
Skin Stretch Sensory Stimuli and TENS in Diabetic Neuropathy

The aim of the research was to find and compare the effects of skin stretch sensory stimuli and transcutaneous electrical nerve stimulation (TENS) on balance in diabetic neuropathy. Randomized controlled trial done at District Headquarter hospital Okara. The sample size was 46. The subjects were divided into 3 groups, 15 subjects in skin stretch sensory stimuli group, 15 subjects in TENS group and 16 subjects in control group. Study duration was of 6 month. Sampling technique applied was convenient non-probability sampling. Patients aged range from 45 to 80 years, having moderate peripheral neuropathy, and decrease sensations were included. Tools used in this study were Berg Balance scale and Toronto clinical neuropathy score system. Data was being analyzed through Spss 21.

Literature shows that various studies was done on diabetic patients for pain reduction, increase proprioception, improve muscle function and muscle recruitment by using kinesio tape and transcutaneous electrical nerve stimulation. There is particularly limited literature available on the effects of skin stretch sensory stimuli on balance in DN patients. Therefore, based on the literature study, there is crucial need for studying the effects of skin stretch sensory stimuli and TENS as a treatment approach. Thus, the current study will be an attempt to know the results of skin stretch sensory stimuli and TENS in DN patients.

Eligibility Criteria:
Inclusion Criteria:

* participants age ranged from 45 to 80 years' old
* Both genders.
* patients with moderate peripheral neuropathy 9-11 on Toronto Clinical Neuropathy Scoring system
* HbA1c levels
* peripheral neuropathic pain of \>6 months' duration involving the lower extremities
* history of diabetes treated with diet, oral hypoglycemic or insulin therapy
* lower extremity symptoms such as muscle pain, decrease in sensations, Achilles tendon reflex, joint position sense of thumb
* Sensory polyneuropathy because of type 2 diabetic diseases
* Ability to walk household distance without assistance or with the use of assistive device such as cane.

Exclusion Criteria:

* Considerable musculoskeletal deformity such as fracture, amputation, abnormality of ROM.
* Previous history of knee or back surgery
* Lower extremity arthritis that prevents standing
* History of cardiovascular problems such as angina, MI
* Symptomatic postural hypotension
* Foot ulceration.
* Skin problems such as rashes etc.
Comparison Study of Surgical Staplers for the Treatment of Hemorrhoids

The purpose of this study is to demonstrate that the Covidien EEA™ Hemorrhoid and Prolapse Stapling Set for the treatment of hemorrhoids is non-inferior to the competitor device based on the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* The subject is able to understand and sign Informed Consent Form
* The subject is between 18-85 years of age.
* The subject has (symptomatic) Grade 2-3 Hemorrhoids and is eligible for stapled hemorrhoidopexy

Exclusion Criteria:

* The procedure is needed as revision hemorrhoid surgery.
* Any female patient, who is pregnant, suspected pregnant, or nursing.
* The participant has an active or a history of infection requiring antibiotics at the intended operative site within thirty (30) days prior to the planned surgery date.
* The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
* The participant has a 1 year history of drug or alcohol abuse.
* The participant has a history of venous thrombosis or pulmonary embolism.
* The participant has a history of coagulopathy.
* The participant has taken aspirin, anti-coagulation and/or anti platelet therapies (e.g. Warfarin, Lovenox) within 7 days prior to the planned date of surgery.
* The participant has a history of fecal incontinence
* The participant has had injection therapy, infrared laser treatment or rubber band ligation for treatment of hemorrhoids within 1 month of screening
* The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.