cyrilzakka/clinical-trials huggingface dataset:
Different Volumes of Local Anesthetics in Thoracolumbar Interfascial Plane Block

Ultrasound-guided thoracolumbar interfascial plane block (TLIP)was first described in 2015 by Hand et al which also target the dorsal rami of the thoracolumbar nerves as they pass through the paraspinal musculature(between the multifidus muscle (MF) and the longissimus muscle (LG)). The block was performed bilaterally at the level of L3 and they reported a reproducible area of anesthesia to pinprick in a mean (SD) area covering 137.4 (71.0) cm2 of the lower back (including the midline) after 20 minutes of the block. This procedure has subsequently been modified by Ueshima H et al in 2016 by targeting the injection in the plane between the longissimus and iliocostalis muscles (mTLIP) which helps avoiding the spread of local anesthetics to the ventral ramus and neuraxial space, thus, the modified TLIP block is considered to be a more refined version of the original TLIP block and safer and easier to perform.

There are limited number of studies investigating the analgesic efficacy of mTLIP block however, no previous study has demonstrated the ideal local anesthetic volume for this block in lumber spine surgery. Moreover, this technique is considered new regional anesthetic techniques and so both of them should be involved in further studies, on the other hand the comparison between both of them at the same study wasn't discussed before, and so we will proceed at this study.

The aim of this study is to compare the post-operative analgesic efficacy of two different volumes of local anesthetics in bilateral modified thoracolumbar interfascial plane block in lumbar spine surgeries.

Prospective randomized double blinded study The study will be conducted in Kasr Alainy hospital orthopedic surgical theater. Adult patients undergoing lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae (eg. laminectomy, discectomy ...). at Kasr Alainy hospital.

Eligibility Criteria:
Inclusion Criteria:

* ● Both gender

  * Type of surgery: lumbar spine surgeries involving 1 up to 3 adjacent lumbar vertebrae
  * Physical status ASA I, II.
  * Age 18 to 65 Years.
  * Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.

Exclusion Criteria:

* ● Patients on preoperative opioid regimen for more than 1 month.

  * Patients with history of previous surgical operations in the lumbar region.
  * Patients with spinal deformities (eg. Scoliosis.....).
  * Hypersensitivity to Bupivacaine.
  * Extensive Lumbar spine surgeries like large tumor excisions, scoliosis correction or more than 2 level spine fixations.
  * Patients with communication difficulties.
  * Lumbar spine operations that will be performed with the patient in any position other than the prone position.
  * Severe neurological compromise (severe muscle weakness such as foot drop or sphincter disorders such as urinary incontinence).
A Comparative Study of Different Hypothermic Circulatory Arrest Strategies on Aortic Surgery.

By comparing the clinical outcome of patients underwent different hypothermic circulatory arrest (mild hypothermic versus moderate hypothermic) during aortic arch surgery, this study aims to determine the optimal hypothermic circulatory arrest strategy for aortic surgery.

Hypothermic circulatory arrest (HCA) is the cornerstone of aortic surgery. It provides a bloodless and still operative field. But the side effect of hypothermia also draws people's concern. With the development of surgical techniques and cardiopulmonary bypass (CPB) management, the temperature of HCA has been raised from deep hypothermia (14.1-20 degree) to moderate hypothermia (20.1-28 degree), and it has been a primary choice for many surgeons around the world. Some of surgeons still tried to push the limit and started using mild hypothermia (28.1-34 degree), and satisfactory outcome was obtained. However, the optimal temperature of HCA has not yet been determined.

In this randomized controlled study, 80 informed and consenting patients who are scheduled for total arch replacement with concomitant proximal aortic reconstruction will be randomized to mild (28.1-34 degree) or moderate (20.1-28 degree) hypothermia during circulatory arrest. Clinical outcomes of both groups will be analyzed to determine the optimal temperature for HCA.

Eligibility Criteria:
Inclusion Criteria:

1.Patients with confirmed diagnosis (i.e.aortic dissection, marfan syndrome, aortic arch aneurysm and so on), which require total aortic arch replacement.

Exclusion Criteria:

1. Preoperative heart attack or coma.
2. Patients with surgical contraindication, including but not limited to severe cardiac,pulmonary,renal or hepatic insufficiency.
3. Pre-existing heart condition or neurological disease.
4. Variation of aortic arch or its branch vessels.
5. Patient is currently on anticoagulation therapy or has other medical condition that compromises the coagulation.
6. Patient with active infection.
7. Allergy to anaesthetic or contrast agent.
8. Pregnant or lactating female.
9. Patient is already on other medical trial.
10. Other medical, psychological or socioeconomics condition determined by investigator that is not eligible for the study.
EXCEL Clinical Trial (Universal Registry)

The purpose of the Universal Registry is to assess the proportion and reasons for which subjects with angiographically significant ULMCA disease requiring revascularization during the time course of this study are not randomized; to compare the baseline characteristics of subjects; and to assess the variability in randomization eligibility and treatment patterns.

Approximately 100 consecutive subjects who otherwise meet all enrollment criteria, will be analyzed separately as intermediate lesion subjects, and will be followed through the time of initial treatment per standard of care with intended PCI, CABG or medical treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are either not eligible for randomization or for other reasons are not randomized will be consented for the Universal Registry
Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Subjects treated with insulin for minimum 3 months
* Duration of diabetes for at least 12 months
* Body Mass Index (BMI) below 30 kg/m\^2
* HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria:

* Current treatment with insulin above 1.2 U/kg/day
* Current treatment with insulin glargine
* Current treatment with drugs known to interfere with glucose metabolism
* Current treatment with oral antidiabetic drugs
Orexin Antagonism for Suicide Risk: a Proof-of-Concept Clinical Trial

The goal of this proof-of-concept clinical trial is to evaluate the initial safety, feasibility, and tolerability of the orexin mixed antagonist suvorexant in a sample of veteran adults with Major Depressive Disorder and elevated suicide risk. The main question it aims to answer is: Is Suvorexant safe, feasible, and tolerable for participants?

Participants will:

* Take Surovexant every day for four weeks (10mg in the first two weeks and 20mg in the second two weeks)
* Visit the medical center at the beginning of the study (week 1), after taking Suvorexant for two weeks (week 3) and following the full Suvorexant dose (week 5) for in-person assessments.
* Fill out self-report assessments (remotely) at week 2 (after one week of Suvorexant) and week 4 (after three weeks of Surovexant)


Eligibility Criteria:
Inclusion Criteria:

* Veteran
* At least 18 years of age (up to 70 years)
* Primary diagnosis of Major Depressive Disorder as determined by the study psychiatrist and confirmed by the Mini-International Neuropsychiatric Interview (MINI)
* Lifetime suicide attempt history and suicidal ideation at baseline as determined by a score ≥2 on the Columbia-Suicide Severity Rating Scale (C-SSRS)

Exclusion Criteria:

* Clinically significant medical or neurological condition
* Current use of strong CYP3A live enzymes or moderate CYP3A inhibitors or strong CYP3A inducers
* Current use of digoxin
* Currently pregnant, not using contraception, nursing, or trying to become pregnant
* Active substance use disorder in the last six months, disorder, or current or past psychotic disorder, bipolar disorder, or obsessive-compulsive disorder
* Severe traumatic brain injury
* Imminent suicidal or homicidal risk
* Free of unstable medical conditions or any contraindication to suvorexant (per FDA prescribing label) as determined by patient interview and review of available medical records.
Follow Up of High Risk Hodgkin Lymphoma in First Complete Remission

Cohort study enrolled high-risk Hodgkin Lymphoma patients in first relapse after induction therapy followed after remission either with a systemic imaging-based surveillance (Imaging cohort) or with standard clinical-based surveillance (standard cohort).


Eligibility Criteria:
Inclusion Criteria:

* High risk Hodgkin Lymphoma
* achievement of complete response to first line therapy

Exclusion Criteria:

* comorbidities that could impair participation in follow-up procedures
Hyperintense: Midlife Hypertension and the Brain

Cerebral small vessel disease (SVD) describes a set of pathologies affecting the smallest blood vessels in the brain. SVD contributes to up to a fifth of ischemic and hemorrhagic strokes en is the main vascular cause of dementia. On MRI, SVD is marked by different types of lesions, including white matter abnormalities, and small infarcts and hemorrhages. Recent studies indicate that SVD develops slowly over the years, starting presumably decades before the typical MRI lesions become apparent. High blood pressure plays an important role in the development of SVD MRI lesions. However, it remains unclear exactly how hypertension leads to vascular pathology. To gain more insight into how hypertension leads to SVD it is important to study mechanisms in individuals (largely) free of SVD, that is before midlife.

Therefore, the investigators aim to examine abnormalities in brain (micro) structure and vascular function in young patients with hypertension. Furthermore, the investigators aim to determine the effects of blood pressure increase and subsequent blood pressure reduction during a period of withdrawal and restart of blood pressure lowering drugs on brain (micro)structure and vascular function.


Eligibility Criteria:
Study 1: cross-sectional study

Inclusion Criteria:

* Age 18-40 years
* Blood pressure above 140/90 mmHg, measured within three months prior to study participation

Exclusion Criteria:

* Pre-existing cerebrovascular disease
* Pregnancy
* Contraindications for 3 T MRI
* Renal function eGFR below 30 ml/min (for Dynamic Contrast Enhanced \[DCE\]-MRI
* Major risk factors for acute ischemic stroke other than SVD according to the TOAST criteria, including, but not limited to, large-artery atherosclerosis, cardioembolism and vasculitis based on medical history and ultrasound of the carotids collected at baseline or any chronic disease that could lead to brain lesions mimicking SVD
* Major (neurological/psychiatric) disease (e.g. multiple sclerosis)
* Not able to give informed consent

Study 2: longitudinal study

Inclusion criteria:

* Age 18-55 years
* Undergoing diagnostic routine of temporary antihypertensive withdrawal for biochemical analysis as part of clinical work-up

Exclusion criteria:

* Pre-existing cerebrovascular disease
* Pregnancy
* Contraindications for 3 T MRI
* Renal function eGFR below 30 ml/min (for Dynamic Contrast Enhanced \[DCE\]-MRI
* Major risk factors for acute ischemic stroke other than SVD according to the TOAST criteria,22 including, but not limited to, large-artery atherosclerosis, cardioembolism and vasculitis based on medical history and ultrasound of the carotids collected at baseline or any chronic disease that could lead to brain lesions mimicking SVD
* Major (neurological/psychiatric) disease (e.g. multiple sclerosis)
* Not able to give informed consent
Immune Response in IXIARO Batch JEV09L37 Recipients Before and After Revaccination

IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.

IC51-319 is a single-arm, open-label study that investigates immune responses in subjects undergoing revaccination after receiving the subpotent batch of IXIARO JEV09L37 during primary immunization.

A total of up to 50 subjects having received primary immunization of IXIARO batch JEV09L37 and who have not yet been revaccinated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 years or older having received IXIARO batch JEV09L37 during primary immunization
* In female subjects, either childbearing potential terminated by surgery or 1 year post-menopausal, or a negative urine pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception
* Written informed consent obtained from the subject prior to any study-related procedures

Exclusion Criteria:

* Vaccination against Yellow fever, Dengue Fever, West Nile Fever or TBE or vaccination with any JE vaccine since primary immunization with IXIARO JEC09L37
* Clinical manifestation of any flavivirus infection since primary immunization with IXIARO JEC09L37
* Acute febrile infections or exacerbation of chronic infection on the day of IXIARO vaccination
* Pregnancy, lactation or unreliable contraception in female subjects with child-bearing potential and unreliable contraception in male subjects.
* Use of any other investigational or non-registered drug within 30 days prior to the first vaccination with IXIARO Visit 1 and during the study period
* Any condition which might interfere with study objectives or would limit the subject's ability to complete the study in the opinion of the investigator
* Persons who are committed to an institution
* At Day 0, upcoming scheduled travel to a JE endemic region
ENT FiberLase CO2 Study

This study is intended to collect data regarding treatment with a new flexible fiber used to transmit laser emitted from a Carbon dioxide (CO2) laser to the transoral region. This study will include a single treatment that is performed transorally (through the mouth) for oral or laryngeal indications in the field of Ear, Nose and Throate (ENT).


Eligibility Criteria:
Inclusion Criteria:

1. General good health allowing patient to undergo general anaesthesia or heavy sedation according to the specific procedure.
2. Adult
3. Able and willing to comply with all visit, treatment and evaluation schedule and requirements
4. Able to understand and provide written Informed Consent
5. Disease which requires tissue ablation for treatment

Exclusion Criteria:

1. Having a bleeding disorder or taking anticoagulation medications, including heavy use of aspirin, in a manner which does not allow for a minimum 10 day washout period prior to each treatment (as per the patient's physician discretion);
2. Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Physician would interfere with the anesthesia, treatment, or healing process
3. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
4. Any condition which, in the Physician's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research
Remote Digital Care Effects in Adolescents With Type 1 Diabetes

Pilot study to evaluate effects of an experimental additional remote digital care (TELEDUC-DIAB) to adolescents with poorly controlled type 1 diabetes using digital monitoring platform and educative app

The use of digital technologies for the support and monitoring of diabetes have gradually become essential in recent years. The scientific literature reveals contrasting effects of digital and mobile technologies, both on adolescents with T1D (type 1 diabetes) and on their relatives. While the majority of studies have focused on connected devices for continuous blood glucose measurement, the specific effects of other tools, such as those of mobile patient therapeutic education applications or medical telemonitoring, are to this day still poorly documented or even unknown.

The study aim to describe the evolution of the glycemic control of adolescents with poorly controled type 1 diabetes during6 months individual TELEDUC-DIAB remote digital care in addition to their conventional follow-up.

The Medical-educational care (TELEDUC-DIAB) consist of:

* a personalized intensified remote care with a healthcare professional
* myDiabby platform: remote monitoring device integrating a data collection platform and systematized monitoring by alarms
* the Kidia application = a patient therapeutic education mobile application: developed by the Enfance, Adolescence et Diabète association, is a mobile application that patients can personalize (avatar,...) and help them understand and empower to deal with their diabetes.

This project offers original and innovative complementary monitoring: remotely, adapted to the specific needs of adolescents and aimed at improving glycemic control by developing self-efficacy and autonomy in adolescents in the management of diabetes.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent aged ≥12 and \<18, with primary type 1 diabetes detected for at least 12 months, treated with multi-injection insulin or insulin pump
* Glycated hemoglobin greater than or equal to 8% for more than 3 months
* Use a continuous interstitial glucose recording system (CGM)
* Have at least one parent/guardian with a significant caregiver role in the management of the adolescent's diabetes (as determined by the investigator) participating in the study
* Have digital media compatible with the digital applications of the TELEDUC- DIAB (Mobile phone and computer)

Exclusion Criteria:

• Other pathologies associated with diabetes which, according to the investigator, could interfere with glycemic control or the management of adolescent diabetes (examples: secondary diabetes, cystic fibrosis, Down syndrome; transplants, corticosteroid therapy, etc.)
Completely Abdominal Approach Laparoscopic Partial Intersphincteric Resection for Rectal Cancer

The conventional intersphincteric resection (ISR) for low rectal cancer requires a combined abdominal and perineal approach, and followed with a handsewn coloanal anastomosis, which is time consuming and difficult to accomplish. A complete laparoscopic abdominal approach partial intersphincteric resection has been proved to be a safe and feasible alternative for low rectal cancer treatment, with the advantages of technical convenience and avoiding a permanent ostomy. But there are few reports concerning differences in clinical outcomes between patients with or without neoadjuvant chemoradiotherapy undergoing partial ISR surgery. Therefore, it is necessary to compare the functional outcomes (including anal and sexual function, and postoperative quality of life \[QOL\]) and oncologic outcomes of patients who underwent completely abdominal approach laparoscopic partial ISR surgery after neoadjuvant chemoradiotherapy, with those who received ISR surgery directly. Furthermore, the operation difficulty between the above two groups is also worthy of intensive study.

Patients with cT1 to cT2 low rectal cancer are directly operated through completely abdominal approach laparoscopic partial ISR surgery. Patients with cT3 low rectal cancer are firstly treated with standard neoadjuvant chemoradiotherapy until down staged to ycT1 to ycT2. The postoperatively functional outcomes and oncologic outcomes between the two groups are compared, including anal and sexual function, QOL and local recurrence rate. The operation difficulty between the above two groups is also investigated, including operation time, the intraoperative and postoperative complications, mesorectum integrity, time for mobilizing the intersphincteric plane, the intactness of the fascia of the levator ani muscle, pubis coccygeus, puborectalis, and external sphincter.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven moderate or well differentiated adenocarcinoma
* Rullier classification of low rectal cancer (types Ⅱ: juxta-anal tumor)
* Clinical staging: initially staged as T1 -2 or down staged to T1-2 after neoadjuvant chemoradiotherapy;

Exclusion Criteria:

* Without signing informed consent, poor compliance
* Unfit for laparoscopy
* Other serious diseases not suitable for participating in this clinical trial
* A degree of preoperative fecal incontinence
* After preoperative neoadjuvant chemoradiotherapy, the sphincter function, sexual function and others involved in this trail are seriously affected
Intermittent Negative Pressure to Improve Blood Flow in Patients With Peripheral Artery Disease: Effects After Long-term Treatment

Studies have shown that intermittent negative pressure (INP) can induce short-term increase in blood flow in the extremity in patients with peripheral artery disease (PAD). Case reports also have indicated that INP treatment has beneficial hemodynamic and clinical effects in patients with lower limb ischemia and hard to heal leg ulcers. However, the clinical and physiological effects of long-term INP treatment are not well documented and needs further investigation.

A double-blinded randomized sham-controlled trial.

Otivio AS is the developer of FlowOx, a noninvasive CE marked device to increase blood flow to the lower extremity. The device acts as a pressure chamber sealed around the patient's lower leg, applying pulses of intermittent negative pressure and atmospheric pressure. The pressure pulses are generated by a control unit, alternating between removing air from- and venting the pressure chamber.

Preliminary tests indicate a significant increase in blood flow to the extremity during INP treatment at -40 mmHg, but a similar increase in blood flow was not detected during treatment INP treatment at -10 mmHg. Hence, treatment with -10 mmHg, may serve as a sham intervention, when evaluating the clinical and physiological effects of long-term INP treatment.

All patients will receive best medical treatment including advice for smoking cessation, dietary advice, and advice for physical exercise, and pharmacological treatment with statins and platelet inhibitors. Patients will be randomized into two groups, one group receiving INP treatment with a pressure of -10 mmHg, the other group receiving INP treatment with a pressure of -40 mmHg. Treatment will be conducted by the patient him/herself at home, one hour in the morning and one hour in the evening for 12 weeks.

Pain-free- and maximal walking distance, ankle-brachial index, arterial blood flow during application of INP, maximal blood flow, and biomarkers of inflammation and endothelial dysfunction will be registered at baseline and after 12 weeks to evaluate the effects of long-term INP treatment.

Eligibility Criteria:
Inclusion Criteria:

* Ankle-Brachial Index \< 0,9, and intermittent claudication

Exclusion Criteria:

* Incapable to make an informed consent
* Inability to perform a treadmill test
* Inability to independently operate FlowOx
* Severe heart disease such as unstable angina pectoris, severe heart failure (NYHA IV), severe valve failure
* Severe COPD