cyrilzakka/clinical-trials huggingface dataset:
A Single Center Study to Characterize the Absorption, Distribution, Metabolism and Excretion (ADME) of ASA404 After a Single Infusion in Patients With Solid Tumors

This study is designed to characterize the absorption, distribution, metabolism and excretion (ADME) of ASA404 following a single intravenous administration of 3000 mg (approximately 1800 mg/m2) ASA404 containing 60 µCi of 14C over a period of 20 minutes in patients with advanced solid tumors. Metabolic pathways, route (s) of elimination, distribution characteristics in plasma and blood, and exposure characterization in plasma and blood, and exposure characterization of the parent drug and metabolites will be obtained from the study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of advanced or metastatic solid tumors for whom either refractory to standard therapy exists, or for whom treatment with an investigational agent alone or in combination with docetaxel, paclitaxel, carboplatin, or paclitaxel plus carboplatin is appropriate;
* ANC≥ 1.5 x 109/L;
* Hgb ≥ 9.0 g/L;
* PLT ≥ 100,000/mm3;
* Total bilirubin ≤ 1.5;
* Willing and able to remain in the clinic for at least 4 days

Exclusion Criteria:

* Patients with CNS and/or leptomeningeal disease metastases allowed on the study unless asymptomatic and not requiring corticosteroid therapy. Patients having any clinical signs of CNS metastases must have a CT or MRI of the brain performed to rule out CNS metastases in order to be eligible for study participation. Patients who have had brain metastases surgically removed or irradiated with no residual disease confirmed by imaging are allowed;
* Patients unable to undergo intravenous infusion;
* Patients with a Baseline 12-lead EGC QTc of \>450 msec;
* Radiotherapy in less than two (2) weeks prior to study entry;
* A history of noncompliance to medical regimens or inability or unwillingness to return for all scheduled visits

Other protocol-defined inclusion/exclusion criteria may apply
Clinical Study of Efficacy and Safety of Chung A Won in Women's Patients With Osteoporosis

A randomized, single center, double blind, parallel, placebo-controlled, clinical study of efficacy and safety of Chung A Won and placebo for 24 weeks three times a day on the improvement of osteoporosis and symptoms in Women's older than 50 patients with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

1)Female more than 50 years old in osteoporosis

Exclusion Criteria:

1. Wash out peroid: using agents more than 3 months against osteoporosis
2. Subject who takes drugs that may affect the clinical trials (Corticosteroids, anticonvulsants, tranquilizers, antidepressants, hypnotic, diuretic)
3. Subject who has a chronic liver disease, thyroid disease and chronic renal disease
4. Subject who is chronic alcoholics and undernourished
5. Other conditions were not suitable in study : Severe physical defects mental defects
6. Pregnant woman
7. Subject who is not calibrated hypercalcemia/hypocalcemia
8. Secondary osteoporosis : Subject who takes drugs(Glucocorticoid, Diabetes Medications)
9. Subject who has 60% more fracture risk in FRAX(WHO fracture risk assessment tool)
Turkish Adaptation of the Activity Limitations in Cerebral Palsy Questionnaire

This study aimed to make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties. Eighty-nine individuals with CP, aged between 2-18 years were included in the study. PEDİ, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM questionnaires were used for validity analysis. Test re-test method was used for reliability.

Cerebral Palsy (CP) is a clinical picture with permanent disorders of the development of movement and posture whether assessing activity limitations matters. This study aimed to make the Turkish adaptation of ACTIVLIM-CP and to examine its psychometric properties.

The internal consistency of the scale was evaluated using Cronbach's alpha value and the inter-measurement reliability using the intraclass correlation coefficient (ICC). In construct validity analysis; ACTIVLIM-CP score; was correlated with PEDİ, ABILOCO-Kids, and ABILHAND-Kids scores and Wee-FIM total scores. A known group comparison was made according to ambulation and epilepsy existence with the Principal Components Explanatory Factor Analysis.

Eligibility Criteria:
Inclusion Criteria:

* children with CP who were diagnosed by a child neurologist
* having physical therapy sessions at special education and rehabilitation center
* age between 2 and 18

Exclusion Criteria:

* whose parent was illiterate or doesn't speak Turkish
* whose parent wasn't complete the questionnaires
Genomic Profiling of Pancreatic Cystic Tumors

This study aims to find out whether quantitative and qualitative analysis, including genetic mutation analysis, of samples obtained from patients with pancreatic cysts is associated with the risk of malignancy, and helpful in the differential diagnosis of mucinous and serous cysts. The study design is a single-arm prospective cohort observational study. Using blood, pancreatic cyst fluid, and pancreatic cyst tissue, genetic mutation analysis and measurement of various biomarkers are performed, and the relationship between these and malignancy or whether they are helpful in distinguishing mucinous and serous cysts is analyzed. The primary outcome is genetic variants of pancreatic cysts associated with malignancy. The secondary outcomes are factors including genetic variants that differentiate mucinous from serous cysts.

Pancreatic cysts, especially mucinous cysts, are precancerous lesions that can cause pancreatic cancer, and follow-up surveillance is important. However, there is a lack of clear medical evidence for the proper method and timing of follow-up, so the current follow-up strategies rely heavily on the opinions of experts. Although mucinous pancreatic cyst is known as a precancerous lesion, the incidence of cancer is about 1-5%. Therefore, if the risk of malignant disease can be more accurately predicted in patients with pancreatic cysts, patients with a high risk of malignant disease can be more intensively monitored and improved survival rates can be expected through early detection of pancreatic cancer. In addition, unnecessary medical resource consumption can be reduced by increasing the follow-up interval of pancreatic cyst patients with low risk of malignancy or not following them at all. To this end, in addition to imaging characteristics of pancreatic cysts, which are currently suggested as risk factors for malignancy in most guidelines for pancreatic cysts, differential diagnosis of pancreatic cysts based on new biomarkers such as genetic mutations and malignant risk assessment are necessary. Therefore, in this study, the investigators comprehensively analyze the blood, pancreatic cyst fluid, and pancreatic cyst tissue of patients with pancreatic cysts to explore biomarkers including genetic mutations that are helpful in the differential diagnosis of pancreatic cyst and the diagnosis of malignant tumors.

Eligibility Criteria:
Inclusion Criteria:

* Pancreatic cyst patients undergoing cyst aspiration or biopsy or surgical resection
* Patients who gave written informed consent

Exclusion Criteria:

* Anyone who has not signed a written consent form.
* Patients deemed unsuitable for research (severe infection, drug abuse, severe mental illness, etc.)
Implication of Human Papillomavirus (HPV) in Lichen Physiopathology in Human (HPVLichen)

Lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration of cluster of differentiation (CD) CD8 T lymphocytes, localized under the basal membrane and associated with apoptosis of basal keratinocytes, suggesting a reactivity of T lymphocytes toward keratinocyte antigen(s), so far unidentified. In a recent study, the research team at Institut Pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive lichen planus), that the immunogenic target of CD8 T lymphocytes could be the immunodominant peptide of Human Papilloma Virus (HPV) 16.

In line with this recent work which shows for the first time a link between HPV-16 and an autoimmune disease, erosive lichen planus, the aim of te study is to test the hypothesis that HPV could be also involved in the pathogenesis of other clinical forms of lichen, such as non erosive lichen planus or lichen sclerosus.

Lichen planus is a chronic cutaneous and mucosal disease characterized by the infiltration of cluster of differentiation (CD) CD8 T lymphocytes, localized under the basal membrane and associated with apoptosis of basal keratinocytes, suggesting a reactivity of T lymphocytes toward keratinocyte antigen(s), so far unidentified. In a recent study, the research team at Institut Pasteur has demonstrated in a peculiar clinical form of lichen planus (erosive lichen planus), that the immunogenic target of CD8 T lymphocytes could be the immunodominant peptide of Human Papilloma Virus (HPV) 16.

In line with this recent work which shows for the first time a link between HPV-16 and an autoimmune disease, erosive lichen planus, the aim of te study is to to test the hypothesis that HPV could be also involved in the pathogenesis of other clinical forms of lichen, such as non erosive lichen planus or lichen sclerosus.

Regarding erosive lichen planus, the aim is to test the cytotoxic function of the previously identified CD8 T lymphocytes specific for HPV16 E711-20.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 year-old
* Clinically or histologically confirmed lichen : Non-erosive lichen planus, Erosive lichen planus, or Sclerosus lichen
* At diagnosis of desease before treatment, or during flares of the disease, with or without intake or topical application of immunosuppressants
* Affiliated or beneficiary of a social security system
* Informed and written consent

Exclusion Criteria:

* Under 18 year-old,
* Legal protection measures,
* Inability to consent
* Pregnant or breastfeeding women.
Randomized Controlled Comparison of Pre-op TLIP Vs Intra-op TLIP

Single-center, randomized study will enroll 50 subjects who are scheduled for 1-3 level posterior laminectomy \& fusion. Study participants who are eligible for the posterior lumbar laminectomy and fusion procedure will be scheduled and also consented as a part of the study. Participants will be stratified based on age and gender to ensure equal distribution.

This is a single-center, randomized study. The study will enroll 50 subjects who are scheduled for 1-3 level posterior laminectomy \& fusion. Potential participants who are eligible for the posterior lumbar laminectomy and fusion procedure will be scheduled as a study participant, consented as a part of the study, and stratified based on age and gender to ensure equal distribution.

For each participant, demographics including age, sex, smoking and alcohol use history, body mass index (BMI), Cranial Cervical Instability (CCI), American Society of Anesthesiology classification (ASA), prior opioid use for pain management, pain levels, function, and prior history of other spinal surgery will be collected prior to surgery. Participants will be randomly assigned to one of two treatment groups: Pre-op ultrasound Thoracolumbar Interfacial Plane Block (TLIP) group or Intra-operative Thoracolumbar Interfacial Plane Block (TLIP) group.

The participant will then undergo the planned 1 to 3 level posterior lumbar laminectomy and fusion procedure.

Post-operative opioid analgesia will be assessed using the Visual Analog Scale (VAS) upon arrival to the post-anesthesia unit (PACU) until discharge and in the outpatient setting. Pain, satisfaction, and opioid analgesia consumption will also be assessed at 2-3 weeks post-operatively, 4-6 weeks post-operatively, and 3 months post-operatively. Pain will be assessed using VAS. Satisfaction will be assessed using a Likert scale. Opioid analgesia is defined as oxycodone, oxymorphone, hydrocodone, hydromorphone, fentanyl, morphine, codeine, methadone, tramadol, and buprenorphine. Opioid consumption will be measured in morphine milligram equivalents (MME).

Eligibility Criteria:
Inclusion Criteria:

* greater than or equal to 18 years of age on the date of service
* require a 1 to 3 level posterior laminectomy with fusion
* compliant with study requirements and outpatient follow-up
* a daily MME less than 25 MME per day in the per-operative period

Exclusion Criteria:

* younger than 18 years of age on the date of service
* does not consent to participating in the program or to be refusal to follow-up at 2-3 weeks, 4-6 weeks, and 3 months post-operatively
* requiring revision surgery at the same level for posterior laminectomy with fusion
* a daily MME score \>25 MME/day in the pre-operative period will be excluded
* a positive drug screen for cocaine and/or tetrahydrocannabinol (THC), defined in the standard Corewell Drugs of Abuse Screening as cocaine \> 300 ng/mL and cannabinoid \> 50 ng/mL-any
* ongoing lawsuits, workers compensation, and litigation will be excluded.
Integrating the Quit and Stay Quit Monday Model Into Smoking Cessation Services for Smokers With Mental Health Conditions

The Quit and Stay Quit Monday model is an innovative smoking cessation approach that guides smokers' behavior without requiring additional resources. The investigator will conduct a randomized control trial evaluating the effectiveness of this model as compared to usual smoking cessation care in a population of smokers with a mental health condition.

The overall objective of this proposal is to innovate the tobacco treatment paradigm for smokers with mental health conditions (MHC) by integrating the Quit and Stay Quit Monday Model into smoking cessation services for this vulnerable population.

The investigator will conduct a two-group, parallel-randomized controlled trial (RCT). The target population will be generated by the NYU Langone electronic medical record (EMR). The investigator will proactively contact patients to offer enrollment and randomize participants 1:1 to one of two groups (n=50/group): (1) Quit and Stay Quit Monday Model or (2) Usual Care. For evaluation, phone surveys will be conducted at baseline and 3-months to assess quit attempts, intervention satisfaction, and smoking cessation.

Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18 years old
2. Has smoked a cigarette in the past 30 days, even a puff
3. Has been diagnosed with a mental health condition or received care from a mental health clinic within the NYU Langone Health system in the prior 12 months
4. Interested in quitting smoking
5. English language
6. Has a phone that can receive text messages
7. Able to provide informed consent

Exclusion Criteria:

1. age \< 18 years of age
2. Non-smoker
Factors Influencing Inclusion in Digestive Cancer Clinical Trials

Since the early 1990s, evidence-based medicine has played an increasingly important role in decision-making for the treatment of patients with cancer. The highest level of evidence is attributed to the results of randomized comparative studies, and the public health authorities require proof from randomized therapeutic trials before authorizing the use of new treatments. Patients included in therapeutic trials benefit either from the best current treatment (control group) or from a treatment supposed to present a better or similar efficacy, together with an extremely rigorous surveillance protocol. Inclusion in a randomized therapeutic trial represents the optimal therapeutic strategy.In order to optimize the fight against cancer, French public health policies have led to the progressive implementation of successive nationwide "Cancer Plans" since 2003. One of the objectives is to increase the proportion of patients included in clinical research trials. Thus, the fraction enrolled in France has progressively increased but remained low at around 8% in 2010. The current 2014-2019 plan aims to expand inclusion to 50,000 patients per year. In a context of socio-economic inequalities that concern resources, residence and access to services, identifying factors that determine inclusion in trials will in turn highlight the reasons for non-inclusion.

The aim of this study was to determine, at a population level, the influence of demographic characteristics and socio-economic status of patients with digestive cancer on inclusion in a clinical trial.

Between 2004 and 2010, 4632 patients were recorded by the Burgundy Digestive Cancer Registry. According to a balancing score, the 136 patients included in a clinical trial were matched with 272 patients who met the eligibility criteria for trials. Deprivation was measured by the ecological European deprivation index. A conditional multivariate logistic regression was performed.


Eligibility Criteria:
Inclusion Criteria:

* patient with digestive cancer residing in Burgundy, France

Exclusion Criteria:

* associated cancer
Comparison of the Effects of Different Exercise Protocols in Individuals with Hallux Valgus

The aim of this study was to determine the effects of 8 weeks of supervised in addition to stretching exercise resisted concentric and eccentric contraction protocol of toe spread out exercise on the angular severity of hallux valgus deformity, changes in the cross-sectional area, stiffness and thickness of the abductor hallucis muscle, electromyographic activities, plantar pressure distribution, foot morphology and gait characteristics, balance and physical performance at the end of the medium and long term.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Being diagnosed with mild or moderate HV according to the radiographic evaluation result,
* Having flexible HV,
* Being a volunteer

Exclusion Criteria:

* Having a neurological disease,
* Having a systemic disease,
* Having cognitive disorders such as dementia, Alzheimer's, etc.,
* Having spinal problems such as disc herniation, lumbar stenosis, scoliosis, etc.,
* Having claudication,
* Having idiopathic numbness, tingling, etc. complaints in the lower extremity,
* Having had lower extremity surgery before,
* Having a fracture, ligament, or muscle injury in the lower extremity within the last 6 months,
* Having received foot-related treatment within the last 6 months.
* Not understanding the exercises,
* Not being able to continue with exercise sessions,
* Low homework exercise compliance,
* Foot structure not suitable for elastographic US examination,
* Incorrectly measured elasticity values in SWE,
* Not participating in the first or last evaluation.
Potential Lead Exposure Through Eating Self-harvested Wild Game

This is a clinical research protocol to determine the feasibility of assessing lead levels in hunters who use lead projectiles. This study will determine if it is possible to perform an interventional double-blind placebo-controlled study of lead levels in hunters using lead or lead-free projectiles following consumption of self-harvested wild game. The hypothesis for the subsequent study is that minute lead particles from shrapnel dispersed through the animal during harvest are ingested and result in increased lead serum levels. This current observational study establishes if this conclusive interventional study is possible through establishing if hunters using lead projectiles in New Zealand have elevated lead levels after eating animals harvested with lead projectiles. This study will be conducted in compliance with the protocol, Good Clinical Practice Standards, associated regulations and institutional research requirements.

This study aims to assess if hunters eating meat shot with lead projectiles experience elevated lead levels. Hunters will be asked to provide blood samples 2-4 days after they eat meat harvested with lead bullets and provide a subsequent sample when they have abstained from eating wild game harvested with lead bullets. We have chosen to use deer as the species for this study to reduce variation and New Zealand is the ideal place to conduct this study because of year-round hunting of deer. This design will allows paired testing of subject lead levels.


Eligibility Criteria:
Inclusion Criteria:

* New Zealand firearms license

Exclusion Criteria:

* Smoker
* Any type of kidney dysfunction
* Individuals working in the following industries that may entail lead exposure:

  1. lead-acid battery manufacture
  2. lead smelting
  3. non-ferrous smelting and casting (e.g. brass)
  4. steel scrap smelting
  5. scrap lead metal handling
  6. cutting/welding steel scrap
  7. machining or polishing lead-containing alloys
  8. plastic production (where lead compounds are used as stabilisers)
  9. demolition
  10. lead soldering
  11. plastic recycling
  12. panel beating
  13. paint removal
  14. sandblasting
  15. leadlight window manufacture
  16. lead casting, e.g. fishing weights, toy soldiers
  17. radiator repair,
  18. car exhaust repair and engine reconditioning (for older makes and models of vehicles)
  19. jewellery (silver) production
  20. shooting range
Pazopanib In Stage IIIB/IV NSCLC Lung Cancer After Progression on First Line Therapy Containing Bevacizumab

This is an open label Phase II Trial that using the investigational anti-cancer agent, Pazopanib to see whether non-squamous non-small cell lung cancer will respond to its use by decreasing the size of the tumor or stopping its growth.

This multi-centered phase II trial will examine pazopanib stage IIIB/IV non-squamous NSCLC patients who have progressed on first-line therapy containing bevacizumab. Treatment should continue until disease progression, unacceptable toxicity, study withdrawal, or death. Patients who progress will be treated at the discretion of their physician. all patients who initiate treatment will be evaluated for disease control rate, which is the primary endpoint of this study.

The primary objective is to estimate the disease control rate of pazopanib alone in patients with stage IIIB/IV non-squamous NSCLC who progressed while on bevacizumab. Disease control rate id defined as complete (CR) + partial response (PR) + stable disease (SD) lasting greater than or equal to 12 weeks as defined by RECIST.

Secondary Objectives To estimate the combined response rate (CR + PR) of pazopanib according to RECIST To estimate the progression free survival (defined as time of enrollment until disease progression or death) and overall survival (defined as time of enrollment until death) of patients treated with pazopanib.

To evaluate the safety and tolerability of pazopanib using the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 4.0 To explore potential correlations between blood biomarkers and clinical response.

Pazopanib is dosed continuously throughout the study. Cycle lengths are identified as 21 days for purposes of the calendar.

The treatment dosage and administration for participating subjects will be, Pazopanib, 800 mg by mouth daily during a 21 day cycle until disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Stage IIIB (with malignant pleural or pericardial effusion or supraclavicular lymph node involvement) or stage IV NSCLC
* Evidence of progression while on bevacizumab
* Patients treated for CNS metastases who are asymptomatic with no requirement for steroids for 2 weeks prior to first dose of study drug

Exclusion Criteria:

* Prior malignancy
* Clinically significant gastrointestinal abnormalities
* Presence of uncontrolled infection or nonhealing wound, fracture, or ulcer
* History of cardiovascular conditions within the past 6 months