cyrilzakka/clinical-trials huggingface dataset:
Consumer Health IT Tools: Impact on Experience, Access, and Outcomes for Patients With Complex Chronic Conditions

Patient use of health IT tools to interact with healthcare providers and delivery systems, including exchanging secure messages with their medical providers and using other web-based tools, has great potential to increase patient access to care, change the way healthcare is delivered, and affect patient clinical outcomes. This study will examine the impact of implementation and use of consumer health IT tools on patient-reported access to care, utilization of medical care services, and clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic conditions
* Patient had at least 10-month membership in 2005

Exclusion Criteria:

* Patients less than age 18
PM8002 in Combination With Paclitaxel Compared With Chemotherapy as Second-line Treatment in Small Cell Lung Cancer

PM8002 is a bispecific antibody targeting PD-L1 and VEGF. This study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel as second-line treatment for SCLC

This multicenter, randomized, open-label phase III study will evaluate the efficacy and safety of PM8002 in combination with Paclitaxel versus Investigator's Choice (Topotecan or Paclitaxel) as second-line treatment for subjects with SCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation in this clinical study; full understanding of the study and voluntary signing the informed consent form; willing to follow and abling to complete all trial procedures;
2. Age ≥18 years but ≤75 years;
3. Histologically or cytologically confirmed SCLC;
4. Advanced SCLC that has progressed or replased after first-line platinum-containing chemotherapy (extensive-stage patients must have received immune checkpoint inhibitors);
5. Having adequate organ functions;
6. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
7. Life expectancy of 12 weeks or more;
8. Having at least one measurable tumor lesion according to RECIST v1.1;

Exclusion Criteria:

1. History of severe allergic disease, severe drug allergy or have known allergy to any component of the study drugs;
2. Previous treatment with Paclitaxel or Topotecan or anti-vascular endothelial growth factor (VEGF) target drugs;
3. Current presence of severe superior vena cava syndrome and spinal cord compression;
4. Adverse events resulting from prior anti-tumor therapies should be assessed and graded according to the CTCAE 5.0 criteria, subjects whose AEs have not returned to Grade 1 or below;
5. Evidence of significant clotting disorder or other significant bleeding risk;
6. History of severe, uncontrollable, or active cardiovascular diseases within 6 months;
7. Current presence of uncontrollable pleural, pericardial, and peritoneal effusions;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome;
9. History of allogeneic hematopoietic stem cell transplantation or allogeneic organ transplantation;
10. History of alcohol abuse, psychotropic substance abuse or drug abuse;
11. Pregnant or lactating women;
12. Other conditions considered unsuitable for this study by the investigator.
The SUPPORT-Pro Online Platform for Healthcare Professionals Treating Individuals Living With T1D

Health care professionals (HCPs) help an support patients living with type 1 diabetes (PWT1D) who need to achieve optimal blood glucose control in order to prevent short and long term complications of T1D. However, studies show that not all HCPs are aware of T1D management as most of them only see PWT1D occasionally. This makes it difficult for HCPs to remain aware of the particularities of the condition and stay up-to-date on rapidly evolving technologies and therapies available. Moreover, low confidence levels and the inaccessibility to continuing medical education on the specificities of new therapies and technologies might increase the failure of HCPs to propose the optimal treatment plan to their PWT1D.

The SUPPORT online platform, that was first developed for PWT1D, was adjusted to suit the needs of HCPs (SUPPORT-Pro). The regularly updated bilingual (English and French) peer-reviewed content of SUPPORT, which covers the various elements that an individual with T1D needs to know to manage the disease and aims at making a better use of technologies and new therapies, is the first in its kind and is highly relevant for HCPs.

The main objective of this study is to determine if the SUPPORT-Pro online training platform can increase HCPs' (dietitians, nurses, pharmacists, medical doctors) confidence level in treating individuals with T1D. This study is a non-randomized pre-post trial. We hypothesize that the training provided through the SUPPORT-Pro online platform will significantly increase HCPs' confidence level in treating individuals with T1D after 3 months when compared to their confidence level before the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Certified Health Care Professional (nurse, physician (including resident in medicine), dietitian, pharmacist) who is member of a regulatory body in Canada
2. Self-reported working with at least 1 patient with type 1 diabetes in the last six months
3. Has access to the Internet
4. Use of an active email address
5. Comprehension of English or French

Exclusion Criteria:

1. Certified diabetes educators
2. Working in a T1D specialized clinic
3. Living with T1D
4. Currently living with someone with T1D (e.g. kid, partner, etc.)
5. Working in the pharmaceutical industry
Ultrasound Elastography Combined With Conventional Mri in Differentiating Solid Renal Parenchyma Masses

Investigate the diagnostic accuracy of Ultrasound Elastography combined with conventional MRI in evaluation of solid renal masses using histopathology as a gold standard.

Renal masses are increasingly detected incidentally during imaging that plays a key role in the characterization of these masses. Renal masses are a biologically heterogeneous group of tumors ranging from benign masses to cancers that can be indolent or aggressive.Typical imaging methods available for differentiating benign from malignant renal lesions include ultrasound (US), contrast-enhanced ultrasound (CEUS), computed tomography (CT), and magnetic resonance imaging (MRI). Renal mass biopsy is considered the gold standard for determining the presurgical histology of renal masses. US can easily characterize most incidental renal masses , but it cannot always differentiate between benign and malignant solid renal tumors.MR imaging has been gaining popularity in recent years as a problem-solving tool in the evaluation of renal masses.It has several advantages including no exposure to radiation and a superior soft-tissue contrast, and may be a feasible initial imaging option for characterization of renal tumors.Ultrasound elastography (USE) is an imaging technology sensitive to tissue stiffness that was first described in the 1990s.It takes advantage of the changed elasticity of soft tissues resulting from specific pathological or physiological processes. Ultrasound-based methods include strain elastography, two-dimensional shear wave elastography (2D-SWE), point shear wave elastography (pSWE), and vibration-controlled transient elastography (VCTE). US elastography is a non-invasive technique that can assess tissue elasticity, has shown promising results in many clinical settings, and could be able to differentiate between benign and malignant renal lesions based on tissue stiffness.

Eligibility Criteria:
Inclusion Criteria:

* patient with solid renal masses.

Exclusion Criteria:

* patient with cystic renal masses.
Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.

The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical \[F-18\]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer \[F-18\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as measured with \[F-18\]DPA-714-PET/MRI.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 65 years of age
2. Healthy volunteer OR Clinical diagnosis of Multiple Sclerosis (MS) OR Meets 2016 American College of Rheumatology (ACR) case definition criteria for fibromyalgia OR Meets 1994 Fukuda case definition criteria for Chronic Fatigue Syndrome

Exclusion Criteria:

1. Contraindication to MRI
2. Pregnancy
3. Lactation
4. Individuals who are unable to participate in the imaging portion due to severity of their medical condition
5. Chronic infectious disease (e.g. HIV, HCV)
6. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation
7. Diagnosis of cancer, including leukemia
8. Blood or blood clotting disorder
9. Except for individuals with MS, a diagnosis of autoimmune disease is exclusionary
10. Positive urine β-hCG test day of procedure or a serum -hCG test within 48 hours prior to the administration of \[18F\]DPA-714
11. Currently enrolled in a clinical trial utilizing experimental therapies
Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS

The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).

Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the mid-luteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle

Eligibility Criteria:
Inclusion Criteria:

* Infertile lean women with PCOS as defined by the Rotterdam criteria.
* CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion Criteria:

* Age \< 20 or \> 35 years.
* Body mass index (BMI) \< 18.5 kg/m2 or \> 25 kg/m2.
* Presence of any infertility factor other than anovulatory PCOS.
* Previous history of ovarian surgery or surgical removal of one ovary.
* Previous exposure to cytotoxic drugs or pelvic irradiation.
* Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
* Metabolic or hormonal abnormalities
CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens

Analgesia in labour is not readily available in many parts of Sub-Saharan Africa. The overall cost of Epidural services in terms of human personnel and financial implication makes this inaccessible to many women in labour. Thus, a cheaper, less technically demanding and easier option that can produce as much satisfaction for the parturient and would allow her participate in the second stage of labour by being able to bare down is being studied.

The Single Shot Spinal (SSS) would provide pain relief in these women however its draw back is its time limitation as the option of a top up is not available.

Two regimen of drug options would be considered using opioids. These would be compared to see how well they are able to provide analgesia in women who hitherto have had vaginal birth. Their onset, duration of action and possible side effects would be compared.

NULL HYPOTHESIS: Single Shot Spinal with Bupivacaine Fentanyl (BF) cannot provide a statistically significant difference in labour analgesia in comparison with Bupivacaine Fentanyl Morphine (BFM) ALTERNATE HYPOTHESIS: Single Shot Spinal with BF can provide a statistically significant difference in labour in comparison with BFM

A double blinded randomized study comparing 2 intrathecal mixtures for labour analgesia.

94 multiparous parturients in active labour who have given informed consent would be recruited into the study. They would be randomly allocated into 2 groups using simple random sampling. An Assistant would know the code and prepare the intrathecal solutions.

Baseline vitals would be taken and patient's pain score noted. Due protocol would be followed and a combined spinal epidural sited but with the epidural not activated until the effect of the spinal wears off.

Routine monitoring would be done and various parameters and indices noted. Where the effect of the spinal lasts the duration of labour thus no need to activate the epidural, this would also be noted.

Data would be analysed using Statistical Package of Social Sciences (SPSS) version 20.

Eligibility Criteria:
Inclusion Criteria:

* Parturients in active labour \>4cm dilatation
* American Society of Anesthesiologists (ASA) classification I and II

Exclusion Criteria:

* Significant co-morbidities like uncontrolled hypertension or diabetes
* Maternal hemorrhage with hypotension
* Significant bleeding/clotting disorders
Lung Ultrasound in Neonatal Intensive Care Units

Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray .

* Lung disease is the most common cause of neonatal respiratory distress.
* It can result in respiratory failure and death in severe cases.
* The mortality rate is approximately 11%:32%.
* Identification of the etiology of lung disease is important for neonatologists.
* Traditionally, chest X-ray has been considered as the most valuable imaging modality for the diagnosis of lung diseases, but it unavoidably causes radiation damage to the patient.
* Neonates are susceptible to radiation because they have rapidly dividing cells that cannot repair mutated DNA.
* The risk of cancer induction in infants receiving a single small dose of radiation is 2-3 times higher than the average population and 6-9 times higher than the risk from an exposure of a 60-year-old patient.
* New imaging modalities have been introduced in clinical practice in recent years such as lung ultrasound.
* One of the most common causes of neonatal respiratory distress that can be diagnosed by ultrasound is :Respiratory Distress Syndrome:

  * Respiratory distress syndrome.. is a major cause of neonatal mortality.
  * It mainly occur in preterm infants due to structural and functional lung immaturity.
  * Pulmonary surfactant insufficiency is an important pathogenesis in respiratory distress syndrome.
  * The ultrasonic features of respiratory distress syndrome are: Compact B-Lines, white lung appearance, abnormality in pleural line (thick and irregular),lung consolidation.
* Lung ultrasound has the advantages of :

  * Non-ionizing.
  * Easy to operate.
  * Low coast.
  * Portable for bedside use.
  * The imaging is performed in real-time.
* Thus making it as a potential tool to be used in neonatal intensive care units.

Eligibility Criteria:
Inclusion Criteria:

* Neonates in neonatal intensive care units

Exclusion Criteria:

* Patients with poor-quality of lung ultrasound image.
* Subcutaneous emphysema.
The Effects of PG102, a Water Soluble Extract From Actinidia Arguta, on Serum Total IgE Levels

The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE in asymptomatic subjects with atopy.


Eligibility Criteria:
Inclusion Criteria:

* subjects who have atopy but no allergy-related symptoms
* subjects with total IgE levels of 300IU/ml or more
* acquisition of written informed consent prior to commencement of study
* no serious clinical symptoms and normal laboratory test results; in case of abnormal finding, subjects whose conditions are not deemed severe from the judgement of investigators

Exclusion Criteria:

* individuals with normal levels of total serum IgE
* ue of one or more allergic drugs
* serious clinical conditions (such as malignancies, severe cardiovascular disease etc.)
* serious mental disorder
* pregnant woman or woman of childbearing potential within 3 months
* subjects who participated in other clinical trials in the past 6months
* individuals who have a plan to participate in another clinical trials during this trial
* subjects with a history of kiwi allergy
* subjects whose conditions are inappropriate by investigators
Safety and Efficacy Study of a New Device for Tattoo Removal

A new mechanical device is evaluated for tattoo removal, comparing two types of needle washing fluids. 30 healthy subjects with tattoos will be treated. The study hypothesis is that the device can be used to achieve satisfactory tattoo removal.

The new device (Eraser TM) uses multiple needles action with a washing fluid to remove tattoos. Healthy patients who wish to remove a tattoo will be enrolled. The study will test the removal of a small part of the tattoo (5cm2 area). Treatment lasts about 20 minutes (with local analgesia if needed), after which an absorptive bandage is put over the treated area for an hour and removed. Treatment may be performed using one of two washing fluids. For one of them, blood samples for material blood level will be taken before and several times after treatment. Pictures of the tattooed area being removed will be taken before and after treatment, and at each follow-up evaluation.

Follow up evaluations will be performed at 1 week, two weeks, one month and two months post treatment. Overall health and skin condition will be evaluated, and the tattoo area will be pictured. Efficacy of tattoo removal will be evaluated after two months, by visual estimation of the percent area that reacted to treatment, and the change in brightness (both evaluated on a 1-5 analog scale). Depending on the result of tattoo removal, and on skin condition, the study treatment will be stopped (if treatment is successful), or may be repeated (up to a limit of two additional times) if the tattoo was not completely removed.

The results of tattoo removal using both washing fluids will be analyzed and compared. A result of 3 or more on the brightness change scale will be considered as a successful treatment.

Pharmacokinetic data for washing fluid no. 2 will be collected and analyzed, to provide Cmax and AUC.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years or older, of any race
* Subject has a tattoo for removal on the back, shoulders or abdomen (areas that can usually be hidden)
* Subjects willing to participate as evidenced by signing the written informed consent

Exclusion Criteria:

* Subject has a dermatological disease, active or latent (e.g. psoriasis)
* Subject has a known tendency for Keloid formation.
* Subject has a known tendency for skin hyperpigmentation.
* Subject is susceptible to Koebner reaction.
* Subject has blood transmittable diseases (HIV, HBV, HCV, etc.)
* Subject has known allergy to device components/ treatment fluids
* Subject has medical conditions that may be worsened by concomitant use of washing fluid, or worsened by local anesthesia materials.
* Subject is taking certain medications or topical preparations.
* Female subject who is pregnant or lactating.
* Subject participating in any other clinical study at the same time
Effect of Acute Nitrate Supplementation on Vascular Function in Hispanic, Black and White Population

The purpose of the study is to assess vascular function in African Americans, Hispanic and Caucasian Americans to better understand racial differences in cardiovascular health. The investigators will further investigate the affect of Beetroot juice on the vascular function of all participants.

African Americans and Hispanic individuals have the highest incidence of type 2 diabetes, which increases their risk of all cardiovascular diseases. One of the hallmarks of type 2 diabetes is vascular dysfunction, caused by a lack of nitric oxide bioavailability. Vascular function and blood flow responses to exercise have been shown to improve after nitrate supplementation (beetroot juice), However, whether nitrate supplementation will improve vascular function in African American and Hispanic individuals remains unknown. The investigators will perform a randomized, placebo-controlled study in healthy African American, Hispanic and Caucasian subjects. They will be studied before and 90 minutes after consuming Beetroot juice (high nitrate supplement) or Placebo, with at least 1-week washout period between the two visits (Kenjale AA et al., J Appl Physiol 2011).

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women who are either Caucasian American, Hispanic, or non-Hispanic African American

Exclusion Criteria:

* Blood pressure higher than or equal to 140/90 mmHg
* BMI \> 35kg/m2
* Have a history of cardiovascular, neurological or vascular diseases
* Take prescription medications
* Are smokers
* Are pregnant
Noninvasive Skin Spectroscopy for Diabetes Screening

The objective of this study is to assess the performance of a noninvasive device for the early screening of Diabetes Mellitus.

Approximately 18 million people have Type II diabetes, and of these, an estimated thirty-five percent are unaware of their condition. This translates to roughly 6.3 million undiagnosed cases worldwide in 2002. Many diagnoses are made years after the onset of the disease. This allows progression of the vascular lesions that arise during the time of uncontrolled glucose levels. As a result, microvascular retinopathy, nephropathy, and neuropathy are on the rise, as well as macrovascular complications such as: coronary heart disease, and cerebral vascular accidents. The prevalence and trends of diabetes underscore the need for effective and widespread screening. Our fluorescence based system under development will noninvasively measure skin glycation end products that are known to be strongly correlated with diabetes status and complications. Since the test would be painless and require no patient fasting, significant obstacles to screening compliance would be mitigated. The system offers hope for a screening test that is more sensitive and specific than the invasive tests currently used for diabetes screening (Oral Glucose Tolerance Test (OGTT) and the Fasting Plasma Glucose (FPG) test).

Eligibility Criteria:
Inclusion Criteria:

* Volunteers without Diabetes.
* Volunteers at risk for developing Type II diabetes.
* 18 years of age and older.

Exclusion Criteria:

* Under 18 years of age.
* Those diagnosed with Diabetes.