cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial Using Spy Elite System in Planning Tissue Advancement Flaps After Ventral Hernia Repair

The purpose of this project is to assess the efficacy of the Spy Elite System (LifeCell Corporation, Branchburg, NJ, USA) in planning tissue advancement flaps and reducing wound complications after complex ventral hernia repairs. Complex ventral hernia repairs are associated with a high rate of wound complications. To a large degree these complications are caused by creating tissue advancement flaps to close the abdomen, which can compromise the blood supply to the skin and subcutaneous tissues. The current standard of care for assessment of blood perfusion to the flaps is a surgeon's clinical judgment. It is, however, often inaccurate. The Spy Elite System was developed to address this problem. The Spy Elite System is a device that enables surgeons to visualize and evaluate tissue perfusion in real time. It can help the surgeon to identify optimal flap design and reduce the risk of postoperative wound complications related to tissue ischemia. The primary goal of this study is to evaluate the efficacy of Spy Elite System to aid a surgeon in creating tissue flaps with adequate blood supply through a prospective, randomized clinical trial. The Spy Elite System has been used successfully for assessing the viability of mastectomy flaps in breast surgery and has been shown to be extremely sensitive in predicting mastectomy flap necrosis. However, no clinical trial has been conducted in order to evaluate the efficacy of the Spy Elite System for assessing the viability of abdominal subcutaneous flaps in complex ventral hernia repairs.

More than 90,000 ventral hernia repairs are performed in the US annually. Large ventral hernias often require a complex abdominal wall reconstruction including creating tissue advancement flaps. Complex abdominal wall reconstructions are associated with up to 20% rate of wound complications including skin flap necrosis and wound breakdowns. Prevention of skin necrosis and ischemia would significantly reduce the morbidity associated with these procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ventral hernia that will require tissue advancement flaps at time of hernia repair
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* ASA score IV or above
* Age \< 18 years
* Patients with iodine allergy
* Patients with current wound or mesh infection
* Pregnant patients
* Patients with End Stage Renal Disease
5 Year Follow-up of Adolescents With Knee Pain

The prevalence of adolescent knee pain is 33%, and patellofemoral pain (PFP) is the most common diagnosis with a nontraumatic onset. The 5-year prognosis of adolescent PFP compared with other types of knee pain is unknown.

In 2011, a cohort of 2200 adolescents aged 15 to 19 years answered an online questionnaire on musculoskeletal pain. Of these, 504 reported knee pain, and 153 of these were clinically diagnosed with PFP. Now, after 5 years, the 504 adolescents, as well as 252 randomly selected adolescents who did not report knee pain in 2011, will be contacted again to gain insights into their prognosis.


Eligibility Criteria:
From the 504, 153 were diagnosed with PFP, the criteria for which included:

- insidious onset of anterior knee or retropatellar pain for longer than 6 weeks that was provoked by at least 2 of the following: prolonged sitting or kneeling, squatting, running, hopping, or stair climbing; tenderness on palpation of the patella; pain when stepping down; or double-leg squatting.

Exclusion criteria were:

* concomitant injury or pain from the hip, lumbar spine, or other knee structures
* self-reported patellofemoral instability
* knee joint effusion.
Brain Health Virtual Reality Study

The Interventions for Brain Health Virtual Reality Study is a NIH-funded clinical research trial at the University of California San Diego (UCSD) Health under the supervision of the study principal investigator Dr. Judy Pa. The overarching goal of this trial is to use a novel virtual reality (VR) based intervention that simultaneously engages physical and cognitive activity aimed at improving brain health and cognition in older adults. The investigators will compare 3 types of interventions: physical activity, VR cognitive activity, and combined VR physical and cognitive activity over 16 weeks to evaluate physical and brain health changes.


Eligibility Criteria:
Inclusion Criteria:

1. 50-85 years of age
2. Fluent in English
3. Can safely ride a stationary bike

Exclusion Criteria:

1. Dementia
2. History of a neurological disorder
3. Severe sensory deficits
4. Inability to perform intervention (e.g., inability to cycle safely)
5. Contraindications to MRI scan (e.g., pacemaker)
6. Fear of needles/ blood
7. Prior history of fainting due to sight of needles of blood
Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma

The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.


Eligibility Criteria:
Main Inclusion Criteria:

* Patients must have histological or cytological evidence of Hodgkin's Lymphoma (all subtypes are acceptable)
* Patients must have relapsed or refractory Hodgkin's Lymphoma (HL) defined as relapse following initial therapy or lack of response to first line therapy and treatment with second-line (salvage therapy). Patients may have also undergone high-dose chemotherapy with autologous stem cell transplantation at least 12 weeks prior to study entry
* Patients must have measurable anatomical disease present on CT scan
* Patients must have an ECOG Performance Score of 0, 1 or 2

Main Exclusion Criteria:

* Patients who have received previous treatment with an HDAC inhibitor
* Patients who have undergone allogeneic hematopoietic stem cell transplantation
* Patients with known or suspected involvement of the CNS by HL
* Patients treated with agents known to prolong the QT interval or with a confirmed QTcF \> 450 msec
* Patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease, excluding patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate with a current PSA \< 0.1 ng/ml; or cervical intraepithelial neoplasia
* Patients with a history of significant cardiovascular, neurological, endocrine, gastrointestinal, respiratory or inflammatory illness that could preclude their participation in the trial, pose an undue medical hazard or interfere with the interpretation of the trial results, including, but not limited to, patients with congestive heart failure (NYHA Class 3 or 4); unstable angina; cardiac arrhythmia; recent (within the preceding 6 months) myocardial infarction or stroke; hypertension requiring \> 2 medications for adequate control; diabetes mellitus with \> 2 episodes of ketoacidosis in the preceding 12 months
Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.

The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.

This study is a Single center, randomized, open-label, Phase IV study to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) administration for 24 Weeks in patients after renal transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Over 19 years old(male or female)
* Patients who are planning to receive a kidney from a deceased or a living non-related/related donor
* Agreement with written informed consent

Exclusion Criteria:

* Previously received organs other than kidneys or who are planed to be transplanted simultaneously
* Diagnosed with cancer in the last five years \[Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be enrolled.\]
* Patients or donors who have positive HIV test result
* Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders
* Severe systemic infection requiring treatment
* Prior to the kidney transplantation

  * Treatment with active liver disease or Liver function test(T-bilirubin, Aspartate transaminase(AST), Alanine transaminase(ALT))is over 3 times than upper normal limit
  * White Blood Cell(WBC) \<2.5 x10\^3/μL, or platelet \<75 x10\^3/μL
* Pregnant women or nursing mothers
* Fertile women who not practice contraception with appropriate methods
* Participated in other trial within 4 weeks
* In investigator's judgment
Surgical Outcome of BCS Using ICG-F in Breast Cancer Patients After Preoperative Chemotherapy

Neoadjuvant chemotherapy for advanced breast cancer has led to an increased rate of breast-conserving surgery (BCS) in these patients. As the demand for preoperative localization methods grows among surgeons performing BCS, traditional localization techniques have shown limitations. For non-palpable breast lesions, preoperative localization has commonly been achieved using ultrasound-guided skin markings or needle localization. However, these methods present challenges, including difficulty in depth localization for patients with large breasts and limitations in real-time re-verification during surgery due to air artifacts after incision. Needle localization, although commonly used, is invasive and poses risks such as displacement or detachment of the needle.

Indocyanine green (ICG), a fluorescent dye that appears green to the naked eye and is detectable by near-infrared (NIR) cameras, has been widely and safely used in clinical practice via intravenous or subcutaneous administration. Recently, ICG combined with NIR imaging has been adopted for sentinel lymph node biopsy in breast cancer and melanoma surgeries and is increasingly used as a localization method for various tumors, replacing conventional techniques.

A preliminary study (IRB No. NCC2016-0071) conducted at the institution evaluated ICG injection and NIR fluorescence imaging for tumor localization in early breast cancer patients undergoing BCS. The study demonstrated the efficacy of ICG-based localization in reducing the rate of positive surgical margins.

The objective of this study is to evaluate the effectiveness of ICG-guided tumor localization with NIR fluorescence imaging in patients with advanced breast cancer treated with neoadjuvant chemotherapy. It is hypothesized that this technique will allow for more accurate tumor excision compared to conventional methods, ultimately improving surgical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* The Patient with locally advanced breast cancer who is eligible for breast-conserving surgery after receiving neoadjuvant chemotherapy
* Aged over 18 years old
* ECOG performance status: 0 or 1
* The patients with written informed consent

Exclusion Criteria:

* The patient who requires total mastectomy after receiving neoadjuvant chemotherapy
* The patient with no residual mass on ultrasonography or only with microcalcifications
* Pregnant or lactating patient
* The patient with a disability to understand and provide consent
* The patient with severe allergic history to indocyanine green
* Iodine-sensitive patient
Evaluation of Human Brain Tumor Therapy Response by Magnetic Resonance (MR)

The purpose of this study is to determine if new MRI methods that measure various information and chemical makeup in the brain, will give early information regarding response to treatment in patients with brain tumors.

The purpose of this study is to see if new MRI methods which measure information related to water, blood flow, and chemical makeup in the brain, can give early information of how well treatment is working in patients with brain tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients over the age of 18 who have been diagnosed with a brain tumor of the central nervous system and a treatment plan has been discussed.
* Must be willing/able to undergo 3-5 MRI scans with IV contrast.
* You can take part in this study if you are NOT afraid of small, enclosed places.

Exclusion Criteria:

* A patient who is claustrophobic.
* Females who are pregnant or lactating.
* Patients who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prosthesis or or implanted neurological stimulator.
* Any patient who has a history of allergic reactions to MR contrast agent (Omniscan, Magnevist, MultiHance)
* Patients who require general anesthesia to complete MRI exam or patients who have had a negative reaction to MRI sedation. (Chloral Hydrate, Pentobarbital or Versed)
* You should NOT have any metals, or implanted devices in your body (such as aneurysm clips, pacemakers, or artificial joints or limbs.). You will need to tell us about your medical history including any surgeries you have had.

Also, if your job or any other experience might have left metal fragments in your body, please let us know, as the MRI has a strong magnetic field could move a metal fragment in your body or interfere with an implanted device, such as a pacemaker, causing you harm.
China Diabetes Cardiovascular Initiative

As a collaborative project between American Heart Association, Chinese Society of Cardiology, American Diabetes Association and Chinese Diabetes Society, the China Diabetes Cardiovascular Initiative aims to enhance the attention and awareness of cardiovascular health care professionals (HCPs) in the managements of cardiovascular diseases and diabetes, to reduce diabetes-related complication and minimize adverse events in patients with cardiovascular disease, and to reduce the risk of cardiovascular morbidity and mortality in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients hospitalized with acute coronary syndrome and diabetes.
2. Aged at least 18 years.

Exclusion Criteria:

None
Topical Vitamin D in Acute Graft Versus Host Disease of the Skin

The purpose of this study is to evaluate the efficacy of Calcipotriene cream. This is a synthetic vitamin D3 derivative for topical use. It is used to treat grade 1-3 acute skin graft versus host disease (GVHD) in hematopoietic stem cell transplant (HSCT) recipients. Calcipotriene will be used as the exclusive topical therapy in addition to standard of care GVHD treatment prescribed for the study subject by the primary physician.

Acute skin GVHD affects about one third of pediatric and adult transplant recipients. Chronic GVHD (cGVHD) affects 40-60% of adult patients who have undergone allogeneic HSCT. It is a major cause of non-relapse mortality and morbidity. Systemic prednisone is the first-line treatment for cGVHD; however, about one-half of all patients do not respond to this initial therapy, and there is no standard second-line therapy. Immunosuppressive therapy used for treatment of GVHD brings significant risk of infection, poorly affecting clinical outcomes.

Vitamin D affects immunoregulation, fibroblast proliferation, collagen synthesis and endothelial cell function, and the investigators hypothesize that topical vitamin D application will have a positive effect on acute and chronic skin GVHD. The investigators hypothesize that topical vitamin D cream may restore normal cell function and decrease the use of steroid creams in acute GVHD of the skin.

Eligibility Criteria:
Inclusion Criteria:

* HSCT recipients with acute Grade I through III GVHD based on Glucksberg criteria. Recipients of multiple transplants are still eligible to participate in this research study.
* Each study subject is to have calcium and vitamin D level prior to starting study, if not obtained within 30 days of beginning treatment.

Exclusion Criteria:

* Patient with active cellulitis at the start of the treatment.
* Patients with hypercalcemia or vitamin D levels above 100 μg/L.
* Patients with known allergy to any of the topical therapy components.
* Patients who have received previous treatment with topical vitamin D cream.
Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial

The aim of this study is to compare three different blood transfusion strategies for coagulopathy correction before central venous catheterization in patients with chronic liver failure (cirrhosis and/or chronic liver graft dysfunction) admitted in intensive care unit.

Central venous catheterization is a ubiquitous procedure in intensive care units and is mainly used for drug administration, hemodynamic monitoring and hemodialysis. Only in US more than five million catheters are inserted annually. One of the main complications associated to central venous lines are the mechanical ones, i.e. arterial puncture, bleeding and hematoma formation, which varies between 5% and 19%. The use of real-time ultrasonography to accomplish central venous catheterization was associated to a drastic reduction in complication rates, and when performed by trained personnel, some series show complications rates \<1%, even in patients with coagulopathy.

Patients presenting with chronic liver failure has a complex coagulation system balance, resulting from reduction in the majority of procoagulant and anticoagulant factors, opposed by preservation of thrombin generation. Thus, these patients are prone to develop hemorrhagic and thrombotic phenomena. The coagulation of cirrhotic patients have been classically evaluated by standard coagulation tests. Nevertheless, these tests present important limitations, as evaluation of plasmatic component only, and do not predict bleeding risk. The thromboelastometry is a point-of-care real-time coagulation system evaluation with the advantage of evaluating the cellular and plasmatic components of the coagulation and present a more comprehensive evaluation of blood coagulation, specially in cirrhotics. This technology is associated with reduced costs in diverse clinical settings.

In clinical practice, approximately 90% of physicians empirically transfuse blood components to cirrhotic patients before invasive procedures. This practice is associated to increased risks related to blood transfusion per se, e.g. blood borne infections, immunologic and non-immunologic adverse reactions, to cite some. Several randomized clinical trials have shown that restrictive blood transfusion strategies are associated to better outcomes, including mortality.

Eligibility Criteria:
Inclusion Criteria:

* Chronic liver failure (cirrhosis or chronic graft dysfunction) from any cause and medical indication of central venous line placement

Exclusion Criteria:

* Acute liver failure or
* Use of therapeutic doses of oral or parenteral anticoagulants (unfractionated heparin or low molecular weight heparin or oral anticoagulants) or
* Use of oral or parenteral platelet aggregation inhibitors or
* Patients with von Willebrand syndrome or
* Over-the-guidewire central venous catheter changing
* Patients previously included in this study protocol during the same hospital stay
Pertussis Infection in Adolescents and Adults With Prolonged Cough

This study aims to determine the burden of pertussis infection among adolescents and adults with prolonged cough in four Asian countries, namely Malaysia, Philippines, Taiwan and Thailand. This study also aims to assess the health economic (HE) impact of pertussis.

Data from this cross-sectional study will be useful in reviewing the need for introduction of booster doses of pertussis vaccines in adolescent and adult population in Malaysia, Philippines, Taiwan and Thailand.

This study will enrol patients with prolonged cough of 2 weeks or more and detect pertussis with serological tests in order to estimate the prevalence of pertussis infection among such patients. No vaccine will be administered during this study.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged 13-18 years or adults aged \>18years.
* Presenting with prolonged cough of 2 weeks (14 days) or more.
* Subjects who the investigator believes that they/ their parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* Written informed consent obtained from the subject/ from the parent(s)/LAR of the subject. If the subject below the age of consent is legally eligible, his/her signature on the informed assent form should be obtained.

Exclusion Criteria:

* Child in care.
* Subjects with known chronic cough-causing disease and immunodeficiency.
* Subjects treated with angiotensin-converting enzyme inhibitors (ACEI), within the past 4 weeks (28 days).
The Brugada Syndrome: a Follow-up Study

Although for many years the Brugada syndrome has been labelled as a purely electrical disease in the structurally normal heart, the evolution of imaging techniques has enabled the discovery of subtle morphofunctional alterations in some of the Brugada syndrome patients. We will use new echocardiographic techniques to assess cardiac function in these patients and new parameters will be evaluated for their prognostic value as risk stratificators.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Diagnosis of Brugada syndrome

Exclusion Criteria:

* history of pericarditis, ischemic heart disease, cardiomyopathy of any origin, structural heart disease, or any other channelopathy
Learning Early Infant Feeding Cues

The goal of this clinical trial is to learn more about responsive infant feeding (recognizing baby's signs of hunger and fullness) in mothers and infant enrolled in government-funded maternal-child home visiting programs. The main questions it aims to answer are:

* What are the contributors and barriers to use of responsive infant feeding?
* How can we refine an intervention focused on responsive infant feeding (the Learning Early Infant Feeding Cues intervention) so that mothers will like it and learn skills to help their baby be healthy.
* Will the refined intervention improve use of responsive feeding and be feasible and acceptable to mothers and home visiting programs?

Participants will be asked to:

* Participate in focus groups to talk about their experiences feeding their baby.
* Participate in a study to learn about responsive feeding and how to use it with their baby. This study will start when mothers are in their final month of pregnancy and finish when their baby is 6 months old. Participation will include:

  * Having someone come to the family home during a time when the baby is eating (either from the breast or the bottle). The mother will receive information on the baby's signs from an experienced coach.
  * Agreeing to be video recording during the session when the baby is eating.
  * Completing surveys online.


Eligibility Criteria:
Maternal Inclusion Criteria

* Pregnant mother in the 3rd trimester (28 weeks or beyond)
* Enrolled in a government-funded maternal-child home visiting program
* Maternal age 18 years or older
* English or Spanish speaking
* Anticipated to have custody of infant after birth
* Healthy pregnancy, no complications that are anticipated to result in a preterm birth or extended hospital stay for mother or infant

Maternal Exclusion Criteria

* Gave birth to multiple fetuses
* Age less than 18 years
* Not fluent in English or Spanish
* Expected to not have custody of the infant after birth

Infant inclusion criteria

* Born as a singleton (not a twin, triplet, etc.) to a mother enrolled in a maternal-child home visiting program
* Born full term (37 weeks or beyond)

Infant exclusion criteria

* Congenital anomaly that may interfere with infant feeding or growth after birth (i.e., Down Syndrome, cleft lip/palate)
* Born preterm (born prior to 37 weeks)
* NICU stay beyond 48 hours
* Infant diagnosis of failure to thrive
* Supplemental oxygen
* Enteral feeding device used for feedings