cyrilzakka/clinical-trials huggingface dataset:
Gefitinib Long-term Survivor Study

The primary objective is to describe the genomic profile of long-term survivors, especially to find out potential genomic prognosis and/or predictive factors for gefitinib long-term efficacy as compared to rapid PD patients


Eligibility Criteria:
Inclusion Criteria:

For inclusion in the long-term survivors group, the study subjects must fulfil the following criteria at the time of screening:

1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
2. Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
3. EGFR mutation positive
4. Patients who continuously received gefitinib for at least 3 years without evidence of PD
5. Patients with OS ≥ 5 years from NSCLC diagnosis will be preferred
6. Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue are optional); tumor tissue samples requirements: 1) slices requirements: \>1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage \> 20% and necrosis \< 30% by pathology QC.

For inclusion in the rapid PD group, the study subjects must fulfil the following criteria:

1. Provision of informed consent or EC approve informed consent waiver prior to any study specific procedures
2. Histological or cytological confirmed locally advanced NSCLC (stage III B) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy
3. EGFR mutation positive
4. Patients who had undergone PD after gefitinib treatment≤3 months (Rapid PD)
5. Collect archival tumour tissue before gefitinib treatment (blood and re-biopsy tumour tissue samples are optional) ; tumor tissue samples requirements: 1) slices requirements: \>1 cm2, thickness 4-5 μm, ≥ 15 slices. or, whole FFPE block; 2) tumor percentage \> 20% and necrosis \< 30% by pathology QC.

Exclusion Criteria:

For the active patients, who must not enter the study if any of the following exclusion criteria are fulfilled 1. Patients who disagree to participate this study.

For the terminated patients, who must not enter the study if any of the following exclusion criteria are fulfilled

1. Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.
Effect of Externally Implantable Tissue Expansion Device on Scar Length

The purpose of this study is to assess whether brief use of an externally implantable tissue expansion device following excisional skin cancer surgery will significantly reduce the diameter of the final wound defect, and hence the length of the final linear primary closure. The secondary objective is to assess the functional benefits, if any, associated with use of the tissue expander.


Eligibility Criteria:
Inclusion Criteria

* Subjects ages 18-80 years old
* Subjects who are undergoing an excision of a large cutaneous lesion
* Subjects with an immediate post-excision wound defect at least 2.5 cm in diameter
* Subjects undergoing surgery on the trunk or extremities
* The subject has willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator.
* Subjects who are willing to undergo no other treatments for the scars for the duration of the study.

Exclusion Criteria

* Subjects with scalp wounds
* Subjects who are unable to understand the protocol or give informed consent
Dapsone Gel 5% and Tretinoin Gel 0.025% Versus Tretinoin Gel 0.025% Monotherapy for Facial Acne Vulgaris

A 12-week evaluation of the safety and efficacy of dapsone gel 5% when used with tretinoin gel 0.025% compared with tretinoin gel 0.025% monotherapy in treating moderate to severe facial acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Facial acne vulgaris characterized by the following:

  * 30-100 facial inflammatory lesions; and, 25-100 facial non-inflammatory lesions;
  * Stable disease, non-rapidly regressing facial acne vulgaris; and, less than or equal to 3 nodules and/or cysts (diameter greater than or equal to 1cm)
* Female subjects of childbearing potential must have a negative pregnancy test at baseline and practice reliable method of contraception throughout the study

Exclusion Criteria:

* Non-compliance with washout period;
* History of clinically significant anemia or hemolysis;
* Skin disease/disorder that might interfere with diagnosis or evaluation of acne vulgaris;
* Allergy or sensitivity to any component of the test medications
Mobile Intervention for Mental Health of Family Caregivers in Thailand

The goal of the R21 project is to develop a culturally informed Caregiver Mental Health Mobile Application program that will promote early detection of mental health problems and deliver an evidence-based self-care intervention for family caregivers providing care to adults with chronic disease in Thailand.

The goal of the 2-year R21 project is to develop a culturally informed Caregiver Mental Health Mobile Application (hereafter referred to as CAMMA) program that will deliver an evidence-based intervention to reduce mental health problems in family caregivers of adults with chronic disorders in Thailand. Specific aims include: 1) Conducting qualitative research on family caregivers of persons with chronic disorders, focusing on their experience with mental health problems, caregiving practice, coping mechanisms, and socio-technological barriers to technology acceptance and use; 2) Develop a mobile application for the delivery of the CAMMA intervention; and 3) Conduct a formative evaluation of the CAMMA Intervention Components to ensure acceptability and usability of individual intervention components.

Eligibility Criteria:
Inclusion Criteria:

* adult (age 18 +) family caregiver (CG)
* has a minimum of 4 months of experience as a caregiver and provides at least 4 hours a day of care to the care recipient (CR);
* screen positive on depressive symptoms (score above 5 on PHQ-9), or generalized anxiety (score above 3 on GAD-2), or stress measured with Perceive Stress Scale (score above 6 on PPS-4)
* Access to a mobile device with internet access

Exclusion Criteria:

* Caregiver who refuses to provide informed consent
Plasmatic Factor V as a Predictor of Graft Dysfunction After Liver Transplantation

Factor V is a coagulation cofactor that is primarily produced by the liver. Previous data has suggested a correlation between factor V levels and graft dysfunction. The investigators hypothesize that Factor V may be a reliable biomarker for hepatic function after LT. Therefore, the aim of this study is to validate the use of Factor V as a predictor of graft dysfunction after LT. This is a single-center prospective validation study. Patients undergoing LT at the University Health Network will have plasmatic Factor V levels measured during postoperative week 1. Patients will be followed up to 12 months. The study outcomes will be early graft dysfunction, and graft and patient survival. Graft loss will be defined as need for retransplantation in the study period.

There is no widely accepted biomarker to assess hepatic function after Liver Transplantation (LT). Factor V is a coagulation cofactor that is primarily produced by the liver. Factor V has a short half-life and its production does not depend on vitamin K, relying mainly on liver function. These singular characteristics make Factor V plasmatic levels strictly linked to liver function. Previous data has suggested a correlation between factor V levels and graft dysfunction. The investigators hypothesize that Factor V may predict graft dysfunction after LT, and become a reliable biomarker for hepatic function after LT. Therefore, the aim is to validate the use of Factor V as a predictor of graft dysfunction after LT. This is a single-center prospective validation study. Participants (patients undergoing LT at the University Health Network) will have plasmatic Factor V levels measured on postoperative days (POD) 1º, 2º, 3º, 5º and 7º. Participants will be followed up to 12 months. The study primary outcome will be early graft dysfunction as defined by Olthoff et al. Secondary outcomes will be 3-, 6- and 12-months graft and patient survival. Graft loss will be defined as need for retransplantation in the study period. Potential confounders will be assessed in a multivariate regression model. No other intervention will be done to the patients. The results of this study may validate the use of this biomarker for graft dysfunction and mortality after LT. These results will impact LT research and direct patient care.

Eligibility Criteria:
Inclusion Criteria:

* Listed for a deceased donor liver transplant at University Health Network
* Able and willing to provide informed consent

Exclusion Criteria:

* Patients unable to provide informed consent
* Recipients of live donor liver transplantation
* Re-transplants
* Recipients of multiple organs
IHERO Study: Insurance, Health and Economic Resources Online for Emerging Adults with Type 1 Diabetes

This research study aims to test a financial and health insurance iHERO Toolkit for young adults with type1 diabetes. The iHERO Toolkit was developed over one year with the type 1 diabetes community, The Diabetes Link organization, and experts. Now, the investigators want to understand the impact of the iHERO Toolkit on diabetes self-management, financial stress, and health insurance literacy outcomes. The investigators are doing this study because it will help to better understand how to support health insurance and financial stress and improve self-management outcomes in young adults with type 1 diabetes. The investigators want to understand how the iHERO Toolkit helps all young adults with diabetes, but especially those on Medicaid and who are racially or ethnically diverse. The investigators will ask participants to participate at four-time points over one year. For the first time, participants will fill out online enrollment and demographic forms and 9 surveys. The 9 surveys have 8-40 short questions each, estimated to take about 45 minutes. Participants will also be asked to complete a home A1c collection with a University Hospitals team member on Zoom.


Eligibility Criteria:
Inclusion Criteria:

* Age range: 18-30 years
* Diagnosis of type 1 diabetes (T1D)
* T1D duration for one year or longer
* Geographical location: residing in the United States.

Exclusion Criteria:

* Inability to answer questions due to cognitive status.
* Inability to read or understand English.
* Diagnosis of insulin-dependent diabetes that is not T1D such as cystic fibrosis-related diabetes, maturity-onset diabetes of the young, or insulin-dependent type 2 diabetes.
Comparison of AMCOP Bioactivator and High-pull Headgear in Treating Skeletal Class II Hyperdivergent Pediatric Patients

The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.

Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.

Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1).

The aim of the present study was to retrospectively compare the clinical use of high-pull headgear versus AMCOP bioactivators for hyperdivergent pediatric patients.

Cephalometric radiographs from pediatric patients treated at the Unit of Orthodontics and Pediatric Dentistry, Section of Dentistry, Department of Clinical, Surgical, Diagnostic and Pediatric Sciences, University of Pavia, Pavia, Italy and at the private practice of Dr. Cardarelli, Isernia, Italy will be collected.

Cephalometric tracing from Giannì analysis will be performed at the baseline (T0) and after 18 months of treatment (T1).

Eligibility Criteria:
Inclusion Criteria:

* mixed or permanent dentition
* skeletal class II malocclusion diagnosed with ANB angle \> 4° from cephalometric radiograph
* skeletal hyperdivergency calculated from AnsPns\^GoGn angle \> 25°, and at least S-Ar\^Go \> 149° or Ar-Go\^Gn \> 137°

Exclusion Criteria:

* lack of compliance in the use of the orthodontic appliance
* syndromic patients, cleft lip or cleft palate, severe malformations and asymmetries of the jaws.
Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial

CrossBoss First is a single-blind randomized controlled trial that will randomize 246 patients undergoing clinically-indicated Chronic Total Occlusion Percutaneous Coronary Intervention, to upfront use of the CrossBoss catheter vs. antegrade guidewire escalation strategy The "CrossBoss First" study has two primary objectives. The primary efficacy objective is to compare the procedure time required to cross the CTO or abort the procedure with a CrossBoss first vs. antegrade wire escalation strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be associated with shorter procedure time required for CTO crossing compared with an antegrade wire escalation strategy.

The primary safety objective is to compare the frequency of procedural major adverse cardiovascular events (MACE) with upfront use of CrossBoss vs. a guidewire escalation strategy. The investigators hypothesize that upfront use of the CrossBoss catheter will be associated with similar incidence of MACE compared with an antegrade wire escalation strategy.

The secondary endpoints are: (1) technical and procedural success4-6; (2) total procedure time (defined as the interval between administration of local anesthesia for obtaining vascular access and removal of the last catheter); (3) fluoroscopy time to cross the CTO and total fluoroscopy time; (4) total air kerma radiation exposure; (5) total contrast volume; and (6) number of wires, microcatheters, balloons, and stents used.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or greater
* Willing and able to give informed consent
* Undergoing clinically-indicated CTO PCI with a planned antegrade crossing approach

Exclusion Criteria:

* Plan for primary retrograde approach for CTO crossing
* Ostial CTOs (within 5 mm of vessel ostium)
Patient Decision Aid for the Treatment of Actinic Keratosis

This study evaluates whether a Patient Decision Aid for the field-directed treatment of actinic keratosis has an effect on shared decision making and patient satisfaction.

Actinic keratosis is the most common epithelial precancerous lesion among the Caucasian race. With an increase in prevalence worldwide due to an aging population and rise of ultraviolet exposure actinic keratosis are among the most frequently encountered skin lesions in clinical practice.

There are many therapeutic modalities for the treatment of actinic keratosis, depending on multiple factors such as distribution, characteristics, patient preference, side effects, availability and costs. Treatment options can be divided into: lesion directed therapy en field directed therapy.

A Patient Decision Aid for field-directed therapies for actinic keratosis may attribute to better shared-decision making and patient satisfaction which on their part may benefits treatment compliance and health outcomes and may lead to fewer disputes between patients and doctors.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis actinic keratosis in MaastrichtUMC+ or CatharinaHospital, Eindhoven
* age \>18 years

Exclusion Criteria:

* no knowledge of Dutch language
Monitoring of Glycocalyx for Prediction of Complications After Cardiac Surgery

This is a prospective observational study of the evolution of the microcirculation and the sublingual glycocalyx in perioperative cardiac surgery under cardiopulmonary bypass. Our main objective is to evaluate the prognostic value of the variation of the thickness of the perioperative glycocalyx for the occurrence of a major complication in the first 24 hours after surgery.


Eligibility Criteria:
* Patient of legal age (age ≥ 18 years)
* Patient undergoing scheduled cardiac surgery with cardiopulmoary bypass (CPB) (expected duration of CPB \> 60 min)
* Person informed with collection of non-opposition at the latest, the day before the operation - Person affiliated to a social security system
Phase 2 Trial of TD-6424 (Telavancin) Versus Standard Therapy for Complicated Gram Positive Skin and Skin Structure Infections (Gram Positive cSSSI)

Serious infections caused by resistant bacteria are becoming more of a medical problem throughout the world. This study will measure how well TD-6424 (Telavancin) can control infections and whether the drug is safe to give to patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of one of the following complicated skin and soft tissue infections and either a suspected or confirmed Gram positive organism

  * major abscess requiring surgical incision and drainage
  * infected burn (see exclusion criteria for important qualifications)
  * deep/extensive cellulitis
  * infected ulcer (see exclusion criteria for important qualifications)
  * wound infection
* Patients must be expected to require at least 4 days of intravenous (IV) antibiotic treatment

Exclusion Criteria:

* Previous systemic antibacterial therapy (with the exception of aztreonam and metronidazole) for \> 24 hours within 7 days prior to the first dose of study drug unless the pathogen was resistant to prior treatment or the patient was a treatment failure (no clinical improvement after 3 days)
* Burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis
Vascular Changes in Pre-Eclamptic Patients and Its Impact on Pregnancy Outcome.

Normal pregnancy is associated with vasodilation and decreased peripheral resistance, which is detected as early as 5 weeks' gestation .

Pre-eclampsia is a multi-system disorder of the second half of pregnancy , which is characterized by increased vascular reactivity and peripheral resistance with pathological changes that are consistent with impaired blood flow to the affected vascular beds. Investigators will evaluate fetal and maternal vascular changes in normotensive and pre-eclamptic patients by Ultrasound and Doppler and their impact on prediction of pregnancy outcome.

Pre-eclampsia affects 2-8% of all pregnancies, although treatment is generally effective. However, 10-15% of direct maternal deaths are associated with Pre-eclampsia and eclampsia(WHO, 2011). There is a considerable evidence that generalized endothelial dysfunction underlies the clinical manifestations of the disease (Oladipupo et al., 2014).

It has been demonstrated that peripheral nutritive blood flow is impaired in pregnancies complicated by pre-eclampsia and precedes onset of the disorder (Kenny et al., 2014).

The pathophysiological mechanism is characterized by a failure of the trophoblastic invasion of the spiral arteries which may be associated with an increased vascular resistance of the uterine artery and a decreased perfusion of placenta. (Al-Jameil et al ; 2014 ) Ultrasound of the brachial artery, and Doppler ultrasound of the carotid artery and uterine artery are propaedeutic , non-invasive methods that contribute to the understanding of the pathophysiology of PE and Eclampsia (Takata et al., 2002 ).

Doppler assessment of the placental circulation plays an important role in screening for impaired placentation and its complications of preeclampsia, intrauterine growth restriction and perinatal death. Assessment of the fetal circulation is essential in the better understanding of the pathophysiology of a wide range of pathological pregnancies and their clinical management(Ghidini \& Vergani, 2012).

Eligibility Criteria:
Inclusion Criteria:

1. All women will be :

   * Nonsmokers,
   * Nondiabetic,
   * With no family history of vascular diseases.
2. Gestational age at enrolment \>28 and \<34 weeks of gestation.
3. Singleton pregnancy.
4. Informed consent.
5. 50 Normotensive pregnant women without complications will be defined as controls.
6. 50 Pre-eclamptic patients.

Exclusion Criteria:

* 1. Patients who presented to labor and delivery were excluded as subjects. 2. Growth-restricted fetus due to:

  * marginal insertion of the umbilical cord,
  * placental infarction,
  * fetal minor heart anomaly,
  * Fetal viral infection. 3. Refusal of patient to participate in the study. 4. Multiple gestations. 5. Autoimmune diseases 6. Previous history of PE or IUGR.
Single-arm Clinical Trial of TACE in Combination With Acoradine as Adjuvant Therapy After Surgery in Patients With Hepatocellular Carcinoma at High Risk of Recurrence

To assess 1-year recurrence-free survival (RFS) in patients with hepatocellular carcinoma (HCC) who are at high risk of Inguinal orchiectomy recurrence usingTACE combined with Acoradine


Eligibility Criteria:
Inclusion Criteria:

1. The subjects voluntarily cooperated with the study and signed the informed consent,
2. Male or female, 18 years old ≤ age ≤75 years old,
3. The histopathologic diagnosis was hepatocellular carcinoma
4. R0 resection was performed within 4 to 8 weeks before recruitment (patients who were confirmed to have R0 resection by imaging and pathological examination were excluded from the study group if the residual R1, residual R2 or the margin of resection were not clear)
5. To satisfy any of the following high risk factors for postoperative recurrence of hepatocellular carcinoma:

   I) BCLC stage B (\&gt; 3 tumors, regardless of size or number, at least one of which is \&gt; 3 cm in diameter) ; ii) single tumor ≥5 cm in diameter; III) intraoperative or postoperative pathological findings of vascular invasion (including microvascular invasion and VP1/VP2 portal vein invasion) ; IV) histopathologic grade of low differentiation; v) capsular invasion or loss with unclear border; VI) direct invasion of adjacent organs
6. ECOG performance status score of 0-1 and Child-Pugh score of 5-6
7. None of the patients had received anti-tumor therapy for hepatocellular carcinoma, including systemic therapy and local therapy (except for 1-2 prophylactic TACE or HAIC 4-8 weeks after radical therapy) .
8. Subjects who received radical therapy, if required, were allowed to receive 1-2 prophylactic TACE/Haic treatments 4-8 weeks after surgery (on demand and not necessarily)

Exclusion Criteria:

1. Known sarcomatoid hepatocellular carcinoma/mixed hepatocellular carcinoma-cholangiocarcinoma/fibrolamellar hepatocellular carcinoma;
2. A history of other malignancies in the past 5 years or at the same time;
3. Severe functional impairment of other important organs such as heart, brain, lung and kidney;
4. Patients with a history of immunodeficiency or autoimmune disease;
5. Evidence of tumor recurrence or metastasis before enrollment;
6. Known hypersensitivity to active ingredients, excipients, or history of severe allergy to any other monoclonal antibody, anti-angiogenic drugs;
7. Patients with a history of hepatic encephalopathy;