cyrilzakka/clinical-trials huggingface dataset:
Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization

The purpose of this study is to test if dexamethasone, an anti-inflammatory medication approved by the US Food and Drug Administration (FDA), can be injected safely into the tissue around the blood vessel wall at the time of an angioplasty or atherectomy.

This is an investigator-initiated, single-arm, external pilot study to assess the safety and feasibility of perivascular administration of dexamethasone following endovascular superficial femoral and popliteal artery angioplasty or atherectomy.

Although dexamethasone is approved by the FDA for injection into blood, skin or joints, it has not been approved by the FDA for injection around blood vessels. The investigators want to find out if this procedure helps prevent re-narrowing of the blood vessel after angioplasty or atherectomy. The dexamethasone will be injected with a Bullfrog® Micro-Infusion catheter, which is an FDA-approved device for injecting medications into tissues around the blood vessel wall. The Bullfrog® Micro-Infusion catheter is similar to other balloon tipped catheters except that it contains a microneedle covered by a fold of semi-rigid balloon. Once the balloon is inflated, the microneedle is uncovered and a medication can be injected into the tissue around the blood vessel.

Eligibility Criteria:
Inclusion Criteria:

* Patient is \> 40 years and \< 80 years of age
* Patient has severe, lifestyle-limiting claudication or critical limb ischemia (Rutherford classification 3-6)
* Patient has TASC II A, B or C disease, SFA revascularization is preferred over medical management, and endovascular approach is preferred revascularization strategy
* Patient has a resting ABI of \<0.9 or an abnormal treadmill ABI. Patients with incompressible arteries must have a TBI \<0.8
* Patient has at least 1 infra-popliteal run-off vessel with patency to the ankle without a \>50% stenosis
* Successful crossing of the lesion with guidewire and successful atherectomy or angioplasty with residual stenosis \<30% as compared to the reference vessels
* Atherectomy procedure does not result in embolization, arteriovenous fistula or perforation
* Patient agrees to return for a clinical assessment duplex ultrasound at 1, 3, 6, 9, 12 and 24 months (routine clinical care)

Exclusion Criteria:

* Patient is simultaneously participating in another investigational drug or device study
* Patient is pregnant or breast-feeding
* Patient has cancer, autoimmune disease, bone marrow or organ transplant, or other concurrent medical illness requiring immunosuppressive therapy
* Patient has end-stage renal disease and chronic kidney disease (eGFR\<30)
* Patient has an active infection
* Patient has a known hypersensitivity or contraindication to heparin, contrast agents, excipients of Dexamethasone Sodium Phosphate Injection, USP, dexamethasone, or other glucocorticoids
* Patient has a life expectancy of less than one year
Extubation Times in Postoperative Congenital Cardiovascular Surgeries

Background: Anesthesia management in pediatric cardiac surgeries focuses on reducing morbidity and mortality, early mobilization and discharge, using health resources sparingly and increasing the quality of life of patients. The duration of postoperative mechanical ventilation is one of the most important factors affecting the process after pediatric cardiac surgery. Besides the view that postoperative mechanical ventilation is safe, there are opposing views that it causes an increase in complications; It caused disagreements about extubation times. In our study, we aimed to investigate the factors affecting extubation times after pediatric cardiac surgery.

Methods: 72 ASA≥III pediatric patients undergoing cardiac surgery with cardiopulmonary bypass were included in our study. The patients were divided into 3 groups according to their extubation time. Those that were extubated in the operating room (OR) or in 6 hours after surgery (Immediate Extubation or IE), those that were extubated within 6-48 hours of admission to the ICU (Early Extubation or EE) and those that were extubated sometime after 48 hours or not extubated (Delayed Extubation or DE). Many variables of preoperative, peroperative and postoperative periods were recorded to see which factors correlated with extubation times.

Children with critical congenital heart disease may need surgical or interventional procedures at some point in their lives.In pediatric cardiac anesthesia, it is important to reduce the need for postoperative mechanical ventilation in order to minimize morbidity, provide optimal vital functions, and reduce unnecessary use of health resources. Researchers aimed to examine the relationships of perioperative and postoperative hemodynamics, laboratory, oxygenation parameters and demographic data with extubation times in pediatric cardiac surgery cases taken in the hospital.

Eligibility Criteria:
Inclusion Criteria:

* elective or emergency patients
* aged 0-18 who are scheduled for congenital heart surgery

Exclusion Criteria:

-in patients who died during the operation
Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent

This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of unruptured intracranial saccular aneurysms.

This study is a prospective multi-centre observational single-arm clinical trial, aiming to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents combined with coils for the treatment of unruptured intracranial saccular aneurysms. As the protocol, clinical follow-up at 30 days (±7 days) after procedure, DSA or MRA follow-up at 6 months (±30 days) after procedure, and clinical follow-up at 1 year (±30 days) after procedure was conducted for each patient. The primary end-points include major adverse events (cerebral infarct and death) in 30 days post-procedure, complete occlusion rate at 6 months (180±30d) follow-up. The secondary end-points were immediate technical success (successful device placement) rate, immediate complete occlusion rate, recurrence rate at 6 months (180±30d) follow-up and in-stent stenosis or obliteration rate at 6 months (180±30d) follow-up. Duration of this study is 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients meeting all the following criteria will be enrolled:

  1. Patients of the age 18-75 years old.
  2. Patients diagnosed with unruptured intracranial saccular aneurysms via CTA, MRA or DSA.
  3. Patients treated with LVIS stents combined with coils.
  4. Patients willing to follow the clinical trial instructions and receive follow-up assessment.
  5. Patients accepting to participate to the study and sign the consent forms.

Exclusion Criteria:

* Patients meeting any following criterion will be excluded:

  1. Patients without proper artery approach.
  2. Patients with AVM.
  3. Patients with a fusiform or dissecting aneurysm.
  4. Patients with a recurrent aneurysm.
  5. Patients treated with a LVIS stent without coils.
  6. Patients in poor clinical status, with mRS ≥4.
  7. Patients with life expectancy less than 12 months.
  8. Patients participated in other clinical trial, while has not reach the primary endpoint.
  9. Patients can not accept anti-platelet regimen.
  10. Patients allergic to contrast agent or intolerable.
  11. Patients whom the researchers consider should not participate in or continue this clinical trial.
Postoperative Sleep Disturbances After Fast Track Hip and Knee Replacement

The purpose of this study is to quantify the degree of sleep disturbances after hip or knee replacement surgery.

Through polysomnographic monitoring the disturbances in sleep stages will be clarified.


Eligibility Criteria:
Inclusion Criteria:

* above 60
* ASA classification I-IV

Exclusion Criteria:

* general anaesthesia within 90 days
* daily use of sedatives
* alcohol abuse
* insufficient written and verbal Danish
* severe hearing loss and poor sight
* Parkinsons Disease or other functional neurological deficits
* Mini mental status \< 24
Evolving Treatment Modalities for Management of Patients Suffering From Disc Displacement With Reduction

Aim of the current study is to compare the efficacy of Low Level Laser, Botulinum toxin type A, and repositioning appliance in management of reduced temporomandibular joint disc.


Eligibility Criteria:
Inclusion Criteria:

* TMJ with audible and palpable click.
* Patients with anterior disc displacement as detected by MRI.
* Presence of full or nearly full complement of natural teeth.

Exclusion Criteria:

* Patients who have radiographic evidence of degenerative conditions of TMJ.
* Patients who have anterior disc dislocation without reduction.
* Previous history of TMD treatment.
* History of recent trauma.
* The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
* Inability or unwillingness to undergo magnetic resonance imaging (MRI) such as implanted electronic devices.
* Pregnant and lactating females.
* Patients with known allergy to botulinum toxin type A.
* Patients suffering from neurological disorders.
Clinical Trial Using Humanized CART Directed Against BCMA (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma to Proteasome Inhibitors, Immunomodulators and Anti-CD38 Antibody.

To assess the safety and efficacy of CARTBCMA ARI0002h in patients with relapsed/refractory multiple myeloma who have received treatment with proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.


Eligibility Criteria:
Inclusion Criteria:

* Patients between the age of 18 and 75 years with diagnosis of multiple myeloma
* Disease measurable by monoclonal component in serum and/or urine or by free light chains in serum according to the eligibility criteria for clinical trials of the International Myeloma Working Group
* Previous two or more lines of treatment. Patients must have received at least a proteasome inhibitor (such as bortezomib or carfilzomib), an immunomodulatory drug (lenalidomide or pomalidomide) and an anti-CD38 monoclonal antibody (such as daratumumab)
* Refractory to the last line of treatment
* ECOG functional status ranging from 0 to 2
* Life expectancy over 3 months
* Patients who, after being informed, give their consent by signing the Informed Consent document.

Exclusion Criteria:

* Previous allogeneic transplant in the prior 6 months to inclusion or GVHD that requires active systemic immunosuppressive treatment
* Absolute lymphocyte count \<0.1x10\^9/ L
* Previous neoplasia, except if patients have been in complete remission \> 3 years, except for cutaneous carcinoma (non-melanoma)
* Active infection that requires treatment
* Active infection by HIV, HBV or HCV.
* Uncontrolled medical disease
* Severe organic condition that meets any of the following criteria: EF \<40%, DLCO \<40%, EGFR \<50 ml / min, bilirubin\> 3 times normal value (except Gilbert syndrome)
* Previous diagnosis of symptomatic AL amyloidosis
* Pregnant or lactating women. Women of childbearing age should have a negative pregnancy test in the screening phase
* Women of childbearing age, including those whose last menstrual cycle was in the year prior to screening, who cannot or do not wish to use highly effective contraceptive methods from the beginning until the end of the study.
* Men who cannot or do not wish to use highly effective contraceptive methods from the beginning to the end of the study.
* Contraindication to receive conditioning chemotherapy
Evaluating Changes of Spino-pelvic Radiological Parameters During Muslim Prayer Positions

This observational study aims to investigate the spinopelvic relationship parameters change during the five main positions during Muslim prayers. The main questions the study is going to answer: What are the changes of the spinopelvic parameters during different Muslim prayer positions?

The spinopelvic relationship refers to the intricate and dynamic interaction between the spine and the pelvis, which plays a crucial role in maintaining posture, balance, and overall musculoskeletal function. The alignment and movement of the spine and pelvis are interdependent, with changes in one structure often influencing the other. Understanding this relationship is essential for diagnosing, managing, and treating various spinal and pelvic conditions; furthermore, these parameters profoundly affect acetabular cup positioning and could affect dislocation rate after total hip arthroplasty.

Evaluating the normal spinopelvic parameters for any particular population is the first step toward detecting abnormal relationships, these were evaluated in various populations, such as Indian, Brazilian, Korean, and Caucasians.

Besides the deficiency of such reports from our area (Middle East), most of the published reports evaluated the change in spinopelvic relationship by evaluating the differences occurring from standing to 90 degrees sitting positions, which ignores most of the positions occurring during Muslim prayer, which necessitates more flexion of the hips and spine during specific position such as prostration (sujud). Activities that involve dynamic movements, such as Muslim prayer positions, can influence spinopelvic parameters. The sequence of postures in Muslim prayers, which includes standing, bowing, and kneeling, places unique demands on the spinopelvic alignment. Understanding how these positions affect spinopelvic parameters is essential for providing insights into the potential implications for musculoskeletal health, particularly in populations that engage in these activities regularly; furthermore, the possibility of proceeding with prayers after THA surgery if the dislocation risk due to impingement is low. What are the changes of the spinopelvic parameters during different Muslim prayer positions and if these changes are different between males and females and if these parameters are affected by participants' body habits, mainly the Body Mass Index (BMI).

Eligibility Criteria:
Inclusion Criteria:

Adult participants (18 to 55 years old) who are willing to volunteer to participate in the study, reporting performing prayer positions without difficulty, had no hip or spine surgeries or complaints (pain or stiffness)

Exclusion Criteria:

* Participants refusing to volunteer.
* Participants who are not able to perform prayer positions comfortably.
* Those who had prior spine or hip surgeries.
Real-World Study on the Efficacy of IBI-322 in Combination With Lenvatinib for the Treatment of Extensive Stage Small Cell Lung Cancer

This is a descriptive observational study, in which data are collected in an epidemiological fashion and prospective. This study does not intend to intervene the current medical practice of the recruited patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥18 years.
* Provision of fully informed consent prior to any study specific procedures.
* Patients with extensive stage SCLC diagnosed by pathology (as staged by the American Veterans Lung Cancer Association (VALG)), who do not have an imaging response during first-line treatment with PD-(L)1 inhibitors, or who progress after imaging reactions on first-line therapy (the most recent regimen prior to enrollment must contain PD-(L)1 inhibitors).
* According to the RECIST 1.1 standard, the patient must have at least one measurable lesion.

Exclusion Criteria:

* None
A Study of RSLV-132 in Females With Sjögren's Syndrome

The goal of this clinical study is to learn if RSLV-132 improves the symptoms of SS in adults. It will also learn about the safety of RSLV-132. The main questions it aims to answer are:

* Does RSLV-132 improve the cardinal symptoms of Sjogren's including fatigue, dryness and pain?
* Does RSLV-132 improve the tiredness/fatigue caused by Sjogren's?
* What are the blood levels of RSLV-132 over time?
* What is the immune (antibody) response in the body to RSLV-132?
* What is the safety profile of RSLV-132?

Researchers will compare RSLV-132 to a placebo (a look-alike substance that contains no drug) to see if RSLV-132 improves the symptoms of pSS.

Participants will:

Take RSLV-132 or a placebo 13 times over 22 weeks Visit the clinic once every week for the first 2 weeks, then every 2 weeks until the end of treatment and then for a final time 4 weeks later (Day 211) for check-ups, tests and to answer questionnaires about their symptoms Record their symptoms every day on an electronic device


Eligibility Criteria:
Inclusion Criteria:

* Providing written informed consent
* Weight at least 45 kg
* Meet the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for pSS
* Diagnosis in the last 10 years
* Positive anti-Ro/SSA antibody test
* Score of 5 or higher on the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) scale and the ESSPRI fatigue scale
* Of non childbearing potential or of childbearing potential and using highly effective contraceptive measures

Exclusion Criteria:

* Diagnosis of any active autoimmune disease other than pSS that could affect the efficacy assessments
* Uncontrolled hypothyroidism or severe fibromyalgia
* New medications or change in medications in the last 4 weeks for pSS symptoms
* Receipt of other prohibited medications
* Apheresis or blood donation
* Allergic reaction to RSLV-132 or biologic therapy
* Clinically significant infection in last 30 days
* Participation in another clinical study
* Malignancy in last 5 years
* Positive test for HIV or hepatitis
* Major surgery in last 30 days or anticipated surgery during the study
* Pregnancy or breast feeding
* Laboratory blood tests outside of specified ranges
* Other medical conditions or medications that would make the participant unsuitable
Transfer From Methadone to Buprenorphine Maintenance Treatment Using Buprenorphine Patches

Buprenorphine is an important alternative to methadone in the maintenance treatment of heroin addiction. Transfer from methadone to buprenorphine requires a reduction of daily methadone dosage below 30 mg to avoid withdrawal after the first buprenorphine intake. The study hypothesis states that the transfer from a daily methadone dosage between 60 mg and 100 mg to buprenorphine can be carried out without withdrawal using buprenorphine patches (35 micro grams per hour) within 12 to 48 hours after last methadone intake.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 60 years
* Methadone maintenance treatment for at least 3 months preceding the study
* Daily methadone dosage between 60mg amd 100mg
* Sufficient knowledge of German language
* Ability to give informed consent

Exclusion Criteria:

* Daily methadone dosage below 60mg amd over 100mg
* Prescribed use of benzodiazepines over 30 mg equivalent to diazepam
* Misuse or dependence of alcohol and/or GHB/GBL
* Pregnant or breast-feeding women
* Known intolerance of buprenorphine
* Somatic diseases interfering with the study plan
Heartmath Migraine Study

This is a two arm study comparing smartphone based heart rate variability biofeedback using the HeartMath app and InnerBalance sensor to waitlist control on migraine quality of life.

The primary objective of this study is to determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) compared to wait list control in migraine quality of life. Investigators will also look:

* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in depression in people with migraine.
* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in anxiety in people with migraine.
* To determine whether there is any superiority between an 8-week program of app based HRV biofeedback (HeartMath) and wait list control in insomnia in people with migraine.

Eligibility Criteria:
Inclusion Criteria:

* International Classification of Headache Disorders (ICHD) 3 criteria for migraine
* 4-20 headache days/month
* Has not done behavioral therapy for migraine in the past year
* Has a smartphone and willing to try HRV biofeedback using an app and ear monitor
* English speaking
* HS graduate or higher level of education
* Patients must not make preventive medication changes for the course of the study. If patients just changed their preventive medication, they must wait a month before enrolling.

Exclusion Criteria:

* Doing any form of behavioral therapy for pain in the past year
A Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of YPI 011 to Rabeprazole in Healthy Adult Subjects

A study to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

This study is to compare the safety, pharmacokinetics and pharmacodynamics of YPI 011 to Rabeprazole in healthy adult subjects

Eligibility Criteria:
Inclusion Criteria:

* Age 19\~55 years in healthy volunteers
* BMI is more than 18.0 kg/m\^2 , no more than 28.0 kg/m\^2
* Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

* Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
* Subjects who were judged ineligible by the investigator
Fetal Cell Analysis From Maternal Blood

The aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a viable singleton or twin pregnancy
* Women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure
* Participant is at least 18 years old and can provide informed consent

Exclusion Criteria:

* Unable to provide informed consent
* Prenatal diagnosis of clinical Chorioamnionitis
* Intake of drugs or exposure to teratogenic agents
* Infections that carry a risk of vertical transmission
* Known maternal viral diseases: HIV and HCV, HBV