cyrilzakka/clinical-trials huggingface dataset:
Korean Registry of Thoracic Endovascular Aortic Repair Timing for Type B Aortic Dissection (K-TEAM Study): A Prospective Multicenter Registry

Prospective, single-arm, multi-center registry study A total of 50 subjects with Type B aortic dissection who meet all inclusion and exclusion criteria will be included.

Patients will be treated with TEVAR using conformable TAG endograft (Gore). Patients will be followed clinically for 12 months after the procedure. CT will be performed at 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. a) In case of acute Type B dissection (14 days from first dissection)

   * Maximum aortic diameter \>40 mm or
   * Increase in aortic diameter \>2 mm from baseline b) In case of subacute (15\~90 days) or chronic (90 days \~ 1 year) Type B
   * Maximum aortic diameter \>55 mm or
   * Increase in aortic diameter \>4 mm from baseline
2. Age 19-80 years.
3. Aorta anatomy appropriate for stent graft therapy,

   1. Proximal landing zone (diameters between 23 and 42 mm) is not aneurysmal, dissected or significantly thrombosed.
   2. Proximal landing zone length \>20 mm (length from the left subclavian artery origin to the primary intima tear or length from the left common carotid artery origin to the primary intima tear when the left subclavian artery is embolized and possibly revascularized), as measured from the outer curve of the aorta.
4. Declaration of voluntary participation in the study with signed informed consent form.

Exclusion Criteria:

1. Endorgan ischemia or evidence of malperfusion due to aortic dissection
2. Aortic rupture or impeding rupture due to aortic dissection
3. Renal dysfunction with serum Cr level \>2.0 mg/dL
4. Marfan syndrome, Loeys-Diets, Ehlers-Danlos syndrome, or other connective tissue diseases
5. Uncontrolled active infection or active vasculitis.
6. Recent myocardial infarction or cerebrovascular accident within 4 weeks prior to study enrollment.
7. Previous thoracic aorta surgery or stent-graft implantation
8. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.
9. Women with positive pregnancy test or at child bearing age
10. Life expectancy \<1 year due to comorbidity
Treating Chinese Smokers With Interactive Expert System

The research study examined the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population.

The research study examines the feasibility, implementation, and efficacy of the interactive expert system intervention for smoking cessation in the Chinese American population. The primary specific aim of the proposed research is to test the following hypotheses: 1) Proactive recruitment approach will be more effective in recruiting smokers who are in precontemplation (no intent to quit smoking in the next 6 months) than a reactive approach. 2) Participants in the experimental condition receiving the interactive stage-matched expert system intervention plus a manual will be more likely to be abstinent at 12 and 18 than those in the control condition receiving a non-interactive standard manual. 3) Participants receiving the interactive expert system intervention will be more likely to report at least one quit attempt than those in the control condition at months 6, 12, and 18. 4) Participants receiving the interactive expert system intervention will be more likely to have a significant decrease in number of cigarettes smoked than those in the control condition at months 3, 6, 12, and 18. After the intervention adaptation and the pilot testing phase of study procedures, the study will achieve the above aims using a randomized trial targeting 400 Chinese American Smokers with follow-up assessments at 3, 6, 12, and 18 months after baseline.

Eligibility Criteria:
Inclusion Criteria:

* residents of the San Francisco Bay Area
* age 18 or older
* self-identified as Chinese in ethnicity
* able to read English or Chinese
* have smoked at least 100 cigarettes in their lifetime
* currently smoke at least 5 cigarettes in the past 7 days

Exclusion Criteria:

* currently engaging in other smoking cessation efforts.
Assessment of Blood and Follicular Fluid Immune Cell Constitution in Patients Undergoing in Vitro Fertilization

The etiology of infertility in the majority of patients with poor response to ovarian stimulation remains unknown. This study will investigate the role of immune cells (T cells, B cells, dendritic cells and NK cells), that constitute the immune system which normally fights infection and cancer. We, the investigators, have found that specialized NK cells that help with new blood vessel formation, are found in the fluid surrounding the egg during IVF, only in patients with good response to ovarian stimulation. We now wish to expand our studies and correlate our findings to ovarian blood flow , as measured by 3D ultrasound and to the presence of other cells in the immune system.


Eligibility Criteria:
Inclusion Criteria:

* Age 27-43 years
* Diagnosis of infertility due to endometriosis, severe male factor, tubal occlusion.
* Patient undergoing IVF

Exclusion Criteria:

* Body mass index (BMI) \> 38 kg/m2
* Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
* Any current use of systemic steroid medication or any infertility treatment within 3 months of study enrollment.
* Any contraindication to being pregnant and carrying a pregnancy to term.
* Any ovarian or abdominal abnormality that may interfere with adequate TVS evaluation.
* Absence of one or two ovaries
* Clinically relevant systemic disease (e.g., Insulin-dependent diabetes, adrenal dysfunction, organic intracranial lesion, polycystic ovarian syndrome, hyperprolactinemia, or hypothalamic tumor) or serious illness (Neoplasia).
* History (within past 12 months) or current abuse of alcohol or drugs.
* Administration of any investigational drugs within three months prior to study enrollment.
* Any medical condition that may interfere with the absorption, distribution, metabolism or excretion of the study drugs, gastrointestinal diseases, mal absorption syndromes and liver dysfunction
* Unexplained gynecological bleeding.
* Ejaculated sperm is not sufficient for ICSI
* Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
* Abnormal COH screening blood done for both partners, including: prolactin, thyroid stimulating hormone, HIV serology, Hepatitis B and C serology, Rubella, group and screen and syphilis serology prior to participation in study.
* Unwillingness to give written informed consent. Previous entry into this study or simultaneous participation in another clinical trial.
A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines

A prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of the cryo-touch II device for the treatment of forehead and/or glabellar lines


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a male or female, 30 to 70 years old.
2. Subject is willing and able to give written informed consent.
3. Subject has a forehead wrinkle rating by the investigator/designee of at least "2" in animation on the 5-point Wrinkle Scale (5WS) which upon physical manipulation/separation of the skin demonstrates a reduction in wrinkle severity. Subject may also have a glabellar score of "1" or higher in animation on a 4-point scale.
4. Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
5. Subject is in good general health and free of any disease state or physical condition that might impair evaluation of forehead and/or glabellar wrinkle rating or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation.

Exclusion Criteria:

1. Subject is currently enrolled in an investigational drug or device study.
2. Subject has used an investigational drug or investigational device treatment within 30 days prior to first administration of the device.
3. Subject has a clotting disorder or has used an anticoagulant (e.g., Coumadin, clopidogrel, etc.) within seven (7) days prior to administration of the device.
4. Subject has used aspirin, or non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen, and naproxen) within seven (7) days prior to administration of the device.
5. Subject has had prior surgery that alters the subcutaneous anatomy of the target treatment sites.
6. Subject has undergone another facial cosmetic procedure at or above the level of the cheekbones within the past six (6) months.
7. Subject has any of the following conditions:

   1. History of facial nerve palsy,
   2. Marked facial asymmetry,
   3. Ptosis,
   4. History of neuromuscular disorder,
   5. Chronic dry eye symptoms,
   6. Allergy or intolerance to lidocaine,
   7. Other local skin condition (e.g., skin infection) at target treatment site,
   8. Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation.
   9. Chronic medical condition that in the investigator's opinion would affect study participation (such as diabetes, hepatitis, HIV, etc.).
   10. Any chronic condition contraindicated for the use of nerve mapping device including heart disease, use of a cardiac pacemaker, and pregnancy.
8. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients

It has been shown that the stress that occurs during cardiac surgery leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to complications after surgery.

This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the outcome and complications after cardiac surgery.

Patients undergoing cardiac surgery are at significant risk for multiple major complications beyond those associated with other major operations. Most patients survive these events, but up to 10% develop injury to organ systems including the kidneys, lungs, pancreas, brain, etc. It has been shown that the stress that occurs during this critical period (cardiac surgery) leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which seem to contribute to these complications.

This study will investigate the effects of high doses of intravenous (IV) Vitamin C administered before, during and after the cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18 years or older undergoing elective or urgent (prior to hospital discharge) cardiac surgery.

Exclusion Criteria:

* History of renal insufficiency, nephrolithiasis, G6PD (glucose-6-phosphate dehydrogenase deficiency) or the chronic use of steroids.
Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D.

The automated TALAS measurement tool, working with the Cone Beam 3D scanner under load, provides a reproducible measurement of the Foot Ankle Offset (FAO). It is possible to determine an average value and the standard deviation of FAO in the relevant population. And to differentiate significantly the populations with a neutral alignment, varus or valgus.

The analysis of the alignment of the foot is fundamental in the management of pathologies of the foot and ankle. The advent of 3D imaging under load (Scanner Cone Beam), less radiant and more precise, requires the development and evaluation of new measurement tools.

The automated TALAS measurement tool, working with the Cone Beam 3D scanner under load, provides a reproducible measurement of the Foot Ankle Offset (FAO). It is possible to determine an average value and the standard deviation of FAO in the relevant population. And to differentiate significantly the populations with a neutral alignment, varus or valgus.

Eligibility Criteria:
Inclusion Criteria:

* Patient selected for a preoperative assessment in foot or ankle surgery, or patient seen in follow-up consultation for which a Cone Beam under load is prescribed
* Patient having been informed of this study and having given their consent
* Patient over 18 years old
* Unprotected adult

Exclusion Criteria:

* Patient with a contraindication to the Cone Beam under load
* Patient refusing to participate in this study
* Non-plantigrade foot under load (impossibility of simultaneously resting M1, M5 and Calcaneus on the ground)
* Patient who has already participated in the 3D HAM study (patients who would have participated in the study during the preoperative consultation for which another Cone Beam would be prescribed during the follow-up consultation. These patients would not be able to participate again in this study).
Performance Evaluation of TB Breath- and Cough-testing Platforms

This will be a prospective, multicentre study conducted to evaluate the diagnostic accuracy of two TB breath-based technologies independently of the manufacturers. Assay error and failure rates and device operational characteristics will also be assessed during this study. Participants will be enrolled in this study in line with FIND sample banking activities. Results from index tests will not be used to make clinical decisions. Participation in this study will not alter the standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Symptoms suggesting pulmonary TB, i.e. persistent cough (generally \> 3 weeks or as per local definition of TB suspect) and at least one other finding listed below:

  1. Persistent cough
  2. Fever
  3. Malaise
  4. Recent weight loss
  5. Night sweats
  6. Contact w/ active case
  7. Hemoptysis
  8. Chest pain
  9. Loss of appetite
  10. Other \[specify\]
* Provision of informed consent to sample collection, banking and HIV and breath-based assay testing
* Production of adequate quantity of sputum (sputum induction whenever possible)
* Adult age (\>18 years old)

Exclusion Criteria:

* Participants receiving any anti-tuberculosis medication, including fluoroquinolone and aminoglycosides in the 60 days prior to enrolment.
* Participants with ONLY extra-pulmonary disease will be excluded.
* Participants for whom complete follow-up and a clear final diagnosis are judged to be difficult (e.g. residents elsewhere or about to move).
Comparison of Self-Fixating vs Non-Fixating Hernia Mesh

The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.

This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years
* ASA Classification I, II, III
* scheduled for elective TEP inguinal hernia repair

Exclusion Criteria:

* ASA Classification IV or greater
* needing emergency surgery
* known history of narcotic dependence
* undergoing bilateral inguinal or combined umbilical hernia repair
* undergoing other procedures during same anesthetic
* undergoing recurrent inguinal hernia repair
Screening of Fabry Disease in Portuguese Patients With Idiopathic Cardiomyopathies

In Portugal, the prevalence of Fabry disease is largely unknown as recently has been stressed by the Portuguese hypertrophic cardiomyopathy registry investigators.

On the other hand, few data on Fabry screening protocols in patients with compromised ejection fraction including burned-out hypertrophic cardiomyopathy series have been published.

This project intends to perform screening of Fabry disease in patients with distinct cardiomyopathy phenotypes of unknown or dubious etiology and explore the less knew impact of the disease in other cardiac phenotypes.


Eligibility Criteria:
Inclusion Criteria:

Patients with heart disease diagnosed after the age of 30:

* unexplained hypertrophic cardiomyopathy (Group A)
* unexplained left ventricle hypertrophy confirmed in two different examinations using the same or different imaging methods (Group B)
* unexplained burned-out hypertrophic cardiomyopathy (Group C)
* unexplained dilated cardiomyopathy with evidence of late gadolinium enhancement involving the basal posterolateral wall segments (Group D)

Exclusion Criteria:

* previous exclusion of Fabry disease
* previous identified causal pathogenic/likely pathogenic genetic variant
* evidence of cardiomyopathy under the age of 30
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant

This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 18-74 years of age
* Single primary liver transplant from a deceased donor
* CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours)
* Patients with hepatitis C-positive status may be entered if they have had an intraoperative (back table) biopsy of the transplanted liver or will have a biopsy at the time of randomization. This is not required for patients negative for hepatitis C.

Exclusion Criteria:

* Liver allograft from a living donor or a split liver
* Multiple organ transplant
* Dialysis therapy for \>14 days from transplantation to randomization
* History of malignancy in the last 5 years (except hepatoma or non-melanoma skin cancer)
* Previous sirolimus therapy
Spinal Versus Local Anesthesia for Hernia Repair

patients underwent inguinal hernia repair; Group A patients received Subarachnoid anesthesia; Group B Patients underwent surgery with local anesthesia (Mepivacaine 2%) performed by the surgeon; Pain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,

All patients underwent inguinal hernia repair with the Trabucco's technique (15), performed by the same surgical team. Every patient was adequately informed of the procedural sequence of anesthesia and surgery and signed informed consent before being enrolled in the study.

For both groups, patients received mild sedation with Midazolam 0.03 mg/kg i.v.; Paracetamol 1 gr and Ketorolac 30 mg i.v. were given before surgery as multimodal pre-emptive analgesia.

Group A Subarachnoid anesthesia was performed with a 27G Whitacre needle at L2-L3 interspace, with patients on the lateral decubitus corresponding to the side of surgery. The introducer was inserted in the middle point of the space between two spinous processes, with a slightly cranial direction. The spinal needle was passed through the introducer and advanced till the subarachnoid space was reached, as confirmed by cerebrospinal fluid outflow.

Subsequently, 60 mg of Prilocaine 2% were administered in the subarachnoid space, with a low-flow injection technique and the needle bevel turned laterally towards the sloping surgical side. Lateral decubitus was maintained for at least 10 minutes (16).

At 15 minutes from spinal anesthesia execution, and before surgery started, sensory and motor block were assessed by ice-test and numerical 0-3 Bromage Scale, respectively.

Group B Patients underwent surgery with local anesthesia (Mepivacaine 2%) performed by the surgeon before skin incision. Further infiltrations of local anesthetic were ensured in case of pain during the surgery, for a maximum of 400 mg of mepivacaine.

In case of uncontrolled pain, fentanyl 50 mcg i.v. was given for a maximum of two intraoperative administrations. If pain persisted, a deep sedation was performed with propofol continuous i.v. infusion.

Pain assessment was performed using a 0-10 Numerical Rating Scale (NRS). Intraoperative pain was assessed every 10 minutes,

Eligibility Criteria:
Inclusion Criteria: indication for inguinal hernia repair; signed informed consent

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Exclusion Criteria: neurological disorders; allergy to local anesthetics; liver disease; serious cardiac conduction problems; severe anemia; cardiogenic or hypovolemic shock; congenital or acquired methemoglobinemia; primitive changes in coagulation; patients treated with class III antiarrhythmics (amiodarone); patients who did not suspend anticoagulants/antiplatelet agents; pregnant patients.
Longitudinal Surveillance Study of the 4-SITE Lead/Header System

Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.

The objective of the LSS of 4-SITE Study is to prospectively determine the chronic complication-free rate of the 4-SITE Lead/Header System in order to verify its clinical performance, long-term reliability and functional integrity. The LSS of 4-SITE Study is a non-randomized, multi-center, global clinical investigation of subjects implanted with the 4-SITE Lead/Header System. The study is designed to collect product performance information, any reportable adverse events and withdrawal data.

The primary purpose of this study is to evaluate, document and report on the appropriate clinical performance, the long-term reliability and the functional integrity of the 4-SITE Lead/Header System. This 4-SITE Lead/Header System consists of a 4-SITE ENDOTAK® RELIANCE defibrillation lead connected to a 4-SITE Header (which is the only PG component under study) of a single or dual chamber (VR and DR) implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy ICD (CRT-D) BSC pulse generator. Additionally, system-related diagnostic information and implant data will be collected during the conduct of this study.

Eligibility Criteria:
Inclusion Criteria:

* medically indicated for ICD/CRT-D
* received/plan to receive study lead
* willing for long-term follow-up

Exclusion Criteria:

* unwilling to comply with protocol
Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia

The purpose of this study is to test the efficacy of a mobile application named ProFibro to promote self-care, and improve symptoms and health-related quality of life in Brazilian patients with fibromyalgia.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of fibromyalgia, according to the 2010 American College of Rheumatology diagnostic criteria
* smartphone user
* complete primary education

Exclusion Criteria:

* being in physical therapy treatment for fibromyalgia or having been treated in the last 3 months
* diagnosis of other chronic pain conditions (neuropathies, rheumatoid arthritis, osteoarthritis, spinal stenosis or cancer)
* severe mental disorders (schizophrenia, psychosis, bipolar affective disorder, severe depression)
* moderate or severe intellectual disability
* hearing or visual impairment