cyrilzakka/clinical-trials huggingface dataset:
A Two Week Study to Assess the Tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) Patients

The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate COPD
* Smokers or ex-smokers
* post-menopausal females

Exclusion Criteria:

* Past history or current evidence of clinically significant heart disease
* Lung disease other than COPD
* Treatment with systemic steroids within 8 weeks of study visit 2
* Treatment with antibiotics within 4 weeks of study visit 1 or study visit 2
Evaluation of MMR Status and PD-L1 Expression Using Specimens Obtained by EUS-FNB in Patients With Pancreatic Cancer

Pancreatic ductal adenocarcinoma (PDAC) has a suboptimal response to standard therapies that modestly impact survival due to its ability to evade host immune surveillance. Emerging evidence has shown that the co-inhibitory receptors, such as programmed death 1 (PD-1), play a critical role in cancer immune-editing. Programmed death-ligand 1 (PD-L1) is an immune checkpoint that is often activated in cancer and plays a pivotal role in the initiation and progression of cancer. The advent of immunotherapy, with checkpoint inhibitors, which block PD-L1 interaction between tumor cells and activated T cells, has significantly altered the treatment algorithm for several solid tumors.

However, the clinicopathologic significance and prognostic value of PD-L1 in PDAC remains controversial. The main technical ground may be that PDAC PD-L1 expression quantification is limited to surgical resection specimens and dependent on specific immunohistochemistry (IHC) tests. In addition, PD-L1 expression has not been extensively assessed before surgery in treatment-naive PDAC patients, due to the current IHC test requirement for a histologic rather than a cytologic evaluation. However, a recent study showed that EUS-fine needle biopsy (FNB) can successfully determine primary pancreas malignancy PD-L1 status.

One recently identified subtype within the genomic landscape of PDAC is the mismatch repair-deficient (dMMR) tumor. Evaluation of dMMR status is particularly important following the FDA approval of the PD-1 inhibitor, pembrolizumab, for the treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or dMMR PDAC that have progressed following prior treatment, and have no satisfactory alternative treatment options.

The objectives of the project will include the assessment of tumor PD-L1/dMMR expression in patients with PDAC using EUS-FNB samples and the prospective correlation of MMR status and PD-L1 expression with overall survival and progression-free survival of PDAC patients.


Eligibility Criteria:
Inclusion Criteria

* Age 18 to 90 years old
* men or women
* signed informed consent for EUS and EUS -FNB
* the diagnosis of adenocarcinoma histologically confirmed by FNB
* resectable, Unresectable, locally advanced and/or metastatic disease

Exclusion Criteria:

-previous chemotherapy or radiotherapy
CAS and Length of Hospital Stay After TKA

The purpose of the study is to prospectively evaluate patients who underwent total knee arthroplasty (TKA) using the Cumulated Ambulation Score (CAS)

The number of patients who receive a total knee arthroplasty (TKA) is steadily increasing and although the reliability and the results of this procedure are excellent, intensive functional rehabilitation is needed postoperatively to obtain satisfactory range of motion. Currently, the standard length of stay at our hospital is between 8 and 10 days for patients who undergo TKA.

The length of stay depends not only on factors such as early mobilization, pain management, major or minor complications and logistical or organizational problems (1) (2). It also depends on the availability of adequate services when the patient needs to be transferred to an appropriate facility. Each of these steps can be further developed in order to improve the quality of care for patients, reduce hospital costs and increase the availability of beds (3). As a result, the reduction in average length of stay would not only result in a reduction in cost but also a greater turnover in the number of patients. Several studies show that the application of a post-operative fast-track strategy may reduce the length of stay in a very significant manner with benefit for patients and hospitals (3).Thus, if their condition allows, patients would have rapid post-operative rehabilitation, with early joint mobilization at D0 (operative day) and walking from D1 (the first post-operative day).

The Cumulated Ambulation Score (CAS) (4) is a tool developed and tested for initial predicting the in-patient length of stay following a hip surgery. The CAS consists of documenting the patient's ability and independence while performing 3 basic daily activities (sit to stand, transfer out of bed and mobilization). It is calculated using a score of 0-2 for each parameter, giving a total daily score of 0 to 6 and a score of 0 to 18 during the first 3 post-operative days. The CAS is then the sum of scores of the first 3 post-operative days. This score proves to be an effective tool for predicting the length of stay, and other parameters investigated such as survival rate and return home after a proximal femoral surgery.

Eligibility Criteria:
Inclusion Criteria: Adults after elective TKA -

Exclusion Criteria: No consent form signed, neurological impairment

-
A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee

The purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data. The primary hypothesis is that Marketed Product (MP01) retains its superiority over Surgical Standard of Care (SSOC) at 7 years in term of mean improvement in the overall Knee Injury and Osteoarthritis Outcome Score (KOOS).

This is a post approval, multicenter, prospective, comparative, non blinded 10-year follow-up observational study of Marketed Product - MP01 vs SSOC used for the treatment of joint surface lesions of the knee. Up to 12 sites in the United States (US) and outside of the US (OUS) that participated in the pivotal study "A Prospective Multicenter Open-label Randomized Controlled Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee" (Marketed Product - MP01 vs. SSOC) will enroll up to 170 subjects who participated in the pivotal study and were not withdrawn due to the index knee requiring a unicompartmental or total knee arthroplasty. Enrolled subjects will be followed up to an additional 5 years post pivotal study procedure. As randomization was 2:1 in the pivotal study, the expected number of Marketed Product - MP01 and SSOC subjects enrolled into this study are approximately 114 and 56, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Participated in the pivotal study.
2. Must be physically and mentally willing and able to comply with the follow-up schedule.
3. Signed and dated the IEC/IRB approved Informed Consent Form and HIPPA (if applicable).

Exclusion Criteria:

1. Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.
2. Chemotherapy in the past 12 months.
3. Participation in other clinical trials involving knee procedures.
4. Vulnerable individual including prisoners (i.e., unable to fully understand all aspects of the study that are relevant to the decision to participate or could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).
Stem Cell Infusion in the Treatment of Patients with Neurological Sequelae After Ischemic Stroke

This trial is to investigate the safety and potential therapeutic efficacy of allogeneic administration of umbilical cord-derived MSCs (UC-MSCs) in combination with standard neurological complications after ischemic stroke treatment in Vietnam.

Stroke is the second leading cause of death behind ischemic heart disease worldwide. Traditional treatments have some limitations whereas preclinical data suggest that stem cell therapy is a promising regenerative medical treatment given the limited capacity of the central nervous system for self-repairs after ischemic stroke. Previous studies have shown that umbilical cord blood-derived Mesenchymal stem cell (UC-MSC) infusion improves the outcomes of several neurological damage conditions, including stroke. These results encouraged us to initiate the phase I/II clinical trial aiming to evaluate the safety and the efficiency of UC-MSC transplantation in the treatment of patients with neurological complications after ischemic stroke. This case-control phase I/II trial is conducted at Vinmec Times City International Hospital, Hanoi, Vietnam between 2021 and 2023. In this trial, 48 patients with neurological complications after ischemic stroke will be enrolled into 3 groups: UC-MSC infusion via intravenous route group (16), UC-MSC infusion via intrathecal administration route group (16), and control group (16). The UC-MSC group (IV/intrathecal) will receive two doses of thawed UC-MSC product at 1.5x106 cells/kg patient body weight with an intervention interval of three months. The primary outcome measures will include the incidence of prespecified administration-associated adverse events (AEs) and serious adverse events (SAEs). The potential efficacy will be measured using these scales including National Institutes of Health Stroke Scale-NIHSS, Functional Independence Measure -FIM, Modified Ashworth Scale-MAS, Fine motor skills-FMS, 36-Item Short Form Survey -SF-36. The clinical evaluation will be conducted at baseline and 3-, 6- and 12-months post-intervention.

Eligibility Criteria:
* Age: from 40 to 75 years.
* Gender: either sex
* Patients have been discharged/patients who are hospitalized but their general condition is stable:

  * No need for vasopressor drugs
  * No need for mechanical ventilation or oxygen support
  * No signs of infection (fever, high WBC, high CRP/Procalcitonin)
  * No kidney failure, liver failure, heart failure.
* Time from onset to study participation ≤ 24 months
* National Institutes of Health Stroke Scale (NIHSS) score \>=5
* Agree to participate in the study

Exclusion Criteria:

* Hematologic cause of stroke
* There is evidence of active infections, failure of heart, lung, liver, or kidney, respiratory distress syndrome, anemia, clotting disorder
* Cancer.
* Pregnancy.
* Tracheostomy, coma, complete quadriplegia, vegetative.
Study of Social Cognition by Morphological and Functional Imaging in Multiple Sclerosis Patients

In recent years, studies have brought knowledge of the difficulties of social cognition in Multiple Sclerosis (MS). The brain tissue alteration at the origin of these difficulties in social cognition mechanisms remain poorly understood. Although recent behavioral studies indicated social disturbances in many of these patients, functional studies investigating specific theory of mind in MS are lacking. The use of new techniques for morphological and functional Magnetic Resonance Imaging (MRI) can identify brain activation networks, mapping the achievement and tissue integrity may be related to disorders of social cognition and cognitive. The investigators propose to study social cognition in MS patients using morphological and functional imaging to determine the mechanisms underlying phenomena such as cerebral compensation and its relationship with cognitive impairment.


Eligibility Criteria:
Inclusion Criteria (patient group):

* Aged 18-59 years
* Right handed
* Fluent French speaker
* MS diagnosis according to McDonald criteria (Polman et al., 2005).
* Relapsing-remitting MS (RRMS) according to Lublin et al. (1996);
* Having signed an informed consent (later than the day of inclusion and before any examination required by research)
* Being affiliated to health insurance

Inclusion Criteria (healthy control):

* Aged 18-59 years
* Right handed
* Fluent French speaker
* Having signed an informed consent (later than the day of inclusion and before any examination required by research)
* Being affiliated to health insurance

Exclusion Criteria (patient group):

* Other progressive neurological disease;
* psychiatric comorbidity including severe depression according to Diagnostic and Statistical Manual-IV (DSM-IV),
* alcohol or other addiction to toxic,
* Expanded Disability Status Scale (EDSS) \> 6; disabling visual or motor problems preventing participation to neuropsychological assessments,
* relapse since less than one month,
* change of disease-modifying therapy or psychotropic drug since less than one month,
* Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI
* Illiteracy, is unable to count or to read
* Pregnant or breastfeeding women
* Being under guardianship

Exclusion Criteria (healthy control):

* History of neurological disease;
* family history of MS;
* psychiatric comorbidity including severe depression according to DSM-IV;
* alcohol or other toxic addiction;
* psychotropic drugs; known cognitive complaint or neuropsychological affection;
* Prior neuropsychological testing with the same tests less than one year
* Contra-indication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, claustrophobia) or refusing MRI
* Illiteracy, is unable to count or to read
* Pregnant or breastfeeding women
* Being under guardianship
Temsirolimus + Weekly Paclitaxel + Carboplatin for Recurrent or Metastatic Head and Neck Squamous Cell Cancer (HNSCC)

The purpose of this study is to find out the good and bad effects that occur when temsirolimus is added to standard chemotherapy with carboplatin and paclitaxel.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have microscopically confirmed head and neck squamous cell carcinoma (HNSCC), recurrent and/or metastatic.
* Confirmation of HNSCC may be obtained from the primary site or metastatic disease.
* Patients must be at least 18 years of age.
* Karnofsky Performance status must be ≥ 70%.
* Disease must be measurable by RECIST criteria.
* At least 6 weeks must have elapsed from previous radiation therapy. Patient must have recovered from the acute toxic effects of treatment prior to study enrollment.
* Adequate organ function, as follows:
* Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 100 X 109/L, and hemoglobin ≥ 9 g/dL.
* Hepatic: total bilirubin within normal limits (≤ 1.0 mg/dL); alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 1.5 X ULN (upper limit of normal)
* Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine \> 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 45 mL/min based on the standard Cockroft and Gault formula.
* Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 3 months following the last dose of study drug.
* Patients must sign an informed consent document.

Exclusion Criteria:

* Previous exposure to temsirolimus or other mTOR inhibitors
* More than 2 prior cytotoxic regimens in the recurrent/metastatic disease setting
* History of any brain metastases
* Patients who require concomitant medications that are metabolized by hepatic CYP3A4, due to potential drug-drug interaction with temsirolimus
* Patients with known active interstitial pneumonitis
* Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
* Women who are pregnant or lactating
* Other active malignancy, other than indolent malignancies which the investigator determines are unlikely to interfere with treatment and safety analysis
* Diagnosis of Nasopharyngeal cancer is excluded.
* Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living)
* Therapeutic anticoagulation with Coumadin (warfarin)
* Hypertriglyceridemia ≥ grade 2 (CTCAE version 3.0).
* Impaired lung function: O2 saturation 88% or less at rest on room air by Pulse Oximetry. If O2 saturation is ≤ 88% at rest, further pulmonary function tests (PFTs) should be ordered to confirm normal pulmonary function and eligibility.
Advance Care Planning Impact on the Consistency of Older Adults With Lung Cancer and Their Potential Surrogates Regarding Life-Sustaining Treatment Preferences

Background: Globally and nationally, malignant tumors persist as the leading cause of high incidence and mortality rates. In Taiwan, cancer tops the list of causes of death, with the elderly being predominantly affected, especially by lung cancer, which is the most prevalent type with the highest mortality and incidence rates in the nation. The Patient Autonomy Rights Act, implemented by the government in 2019, is designed to promote advance medical care consultation in medical institutions, respecting patient's autonomous decisions. In Chinese culture, medical decisions are typically family-oriented rather than individualistic, leading the elderly to frequently rely on their relatives'choices. This cultural practice may prevent meaningful conversations between potential agents and the elderly, causing misunderstandings of the elderly's preferences and affecting the consistency of medical decisions. Presently, interventions like board games for Advance Care Planning (ACP) are not well received, highlighting the need for more captivating content in intervention strategies.


Eligibility Criteria:
Inclusion Criteria:

1. lung cancer age ≧ 60
2. The elderly with lung cancer are conscious and have no severe visual or hearing impairment.

3.3. The potential agent is designated by the elderly person with lung cancer who may be a family member who may make medical decisions in the future. The potential agent must be at least 18 years old.

Exclusion Criteria:

1. People with severe hearing loss and visual impairment who are unable to communicate in Mandarin and Taiwanese.
2. The potential agent is under 18 years old
Impact of Electronic Cigarettes on Perinatal Immune Responsiveness and Birth Outcomes

There has been a dramatic escalation of electronic cigarette (e-cig) use among women of childbearing age, including pregnant women. The overall goal of this study is to determine the effects of e-cigs on prenatal biomarkers and birth outcomes. It is imperative that more data about these effects be available to better inform women of childbearing age.

The United States has the largest and fastest growing market for electronic cigarettes (e-cigs), and adult women of childbearing age are the most common users. However, no data exist regarding the health effects of e-cigs on pregnant women or their babies. It is well known that tobacco use during pregnancy is the most modifiable risk associated with adverse birth outcome, yet nearly one in four women in Kentucky continue to use tobacco products during pregnancy. E-cigs also contain varied (unregulated) concentrations of nicotine, despite nicotine being classified as a pregnancy class-D drug (exhibiting teratogenic effects on the fetus). The addictive nature of nicotine may explain continued use during this vulnerable time.

E-cigs have been the center of recent controversy regarding novel smoking cessation or harm reduction products. There is also concern that marketing strategies promoting harm reduction may increase the appeal and obfuscate the known adverse effects of nicotine on fetal development. In addition to the adverse effects of prenatal nicotine, maternal tobacco use alters immune response during pregnancy, placing women at increased risk for preterm birth.

The overall goal of this study is to determine the effects of e-cigs (and dual use) on perinatal biomarkers and birth outcomes. Three hundred and sixty pregnant women will be recruited. Participants will complete a survey to measure tobacco related behaviors, and provide perinatal biomarkers at four time points (each trimester and postpartum). Data analysis will include a series of repeated ANCOVAs to determine the association of perinatal cigarette smoking (conventional, e-cigarettes-only, and dual use) with perinatal biomarkers. A one-way ANCOVA will be used to determine the association with birth outcomes. Primary biomarker measures include: expired air carbon monoxide, urine and serum cotinine, serum immune markers and urinary NNAL. Gestational age at birth and birth weight are the primary birth outcomes.

Until more data about the effects of e-cigs and dual use on perinatal immune response and birth outcomes are available, promotion of e-cigs during pregnancy would be premature. There is an urgent need to investigate the impact of e-cigs and dual use on perinatal biomarkers and birth outcomes. The lack of research may unnecessarily place women-and their babies -at risk for lifelong adverse health outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. current tobacco use (traditional cigarettes and/or electronic cigarettes ecig, ENDS)
2. pregnant in the first or second trimester
3. age 18-44
4. can read and write in English.

Exclusion Criteria:

-
Post Marketing Surveillance Of Fesoterodine In Filipino Patients With Over Active Bladder

This is an observational study and will determine the safety profile of fesoterodine in Filipino patients prescribed the drug. This is in compliance with the requirements of the Philippine Food and Drug Administration.

Sampling method is not applicable in this study. Only patients prescribed Fesoterodine will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Over-active bladder
* Prescribed with Fesoterodine

Exclusion Criteria:

* Hypersensitivity
* Urinary retention
Epidural Stimulation in Chronic Spinal Cord Injury Patients

Investigators propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular, urinary and sexual function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment. In addition investigators suggest to prove on functional magnetic resonance imaging if there are some significant changes before and after the stimulation.


Eligibility Criteria:
Inclusion Criteria:

* non-progressive SCI with complete motor paralysis below T1; American Spinal Injury Association Impairment Scale (AIS) A or B
* 18 - 60 years of age;
* longer than 2 years post injury;
* stable medical condition
* unable to voluntarily move all single joints of the legs;
* spinal cort lesion between C7 and Th10

Exclusion Criteria:

* ventilator dependent;
* painful musculoskeletal dysfunction, unhealed fracture, contracture, or pressure sore that might interfere with training;
* clinically significant depression or ongoing drug abuse;
* cardiovascular, respiratory, bladder, or renal disease unrelated to SCI;
* severe anemia (Hgb\<8 g/dl) or hypovolemia; and HIV or AIDS related illness.