cyrilzakka/clinical-trials huggingface dataset:
A Study of Atezolizumab as First-line Monotherapy for Advanced or Metastatic Non-Small Cell Lung Cancer

This was a Phase II, open-label, prospective, multicenter study designed to evaluate the efficacy and safety of single-agent atezolizumab as a first-line therapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC). In addition, the primary biomarker objective was to measure blood tumor mutational burden (bTMB) and evaluate whether it can predict for improved clinical outcome with atezolizumab.


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Histologically or cytologically confirmed Stage IIIB-IVB NSCLC
* For participants who have received prior neo-adjuvant/adjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease: a treatment-free interval of at least 6 months prior to enrollment
* Participants with any programmed death-ligand 1 (PD-L1) test result by immunohistochemistry (IHC) are eligible for the study
* Participants without a PD-L1 test result are eligible for the study
* Measurable disease per RECIST v1.1
* Adequate hematologic and end-organ function
* Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods among women of childbearing potential

Exclusion Criteria:

* Prior treatment with immunotherapy for any stage NSCLC, including early-stage (neoadjuvant or adjuvant) disease
* Participants with epidermal growth factor receptor (EGFR) sensitizing mutations and anaplastic lymphoma kinase (ALK) rearrangements
* Active central nervous system (CNS) metastases requiring treatment
* Spinal cord compression not definitively treated or not clinically stable
* Leptomeningeal disease
* Uncontrolled tumor-related pain
* Uncontrolled pleural, pericardial effusions, or ascites requiring recurrent drainage procedures
* Uncontrolled or symptomatic hypercalcemia
* Malignancies other than NSCLC within 5 years prior to enrollment, except for those curatively treated with negligible risk of metastasis or death
* Pregnant or lactating women
* History of autoimmune disease, significant pulmonary disease, or significant cardiovascular disease
* Positive human immunodeficiency virus (HIV) or hepatitis B or C
* Active tuberculosis
* Severe infection or major surgery within 4 weeks, or oral or IV antibiotics treatment within 2 weeks prior to enrollment
* Prior treatment with or hypersensitivity to study drug or related compounds
* Prior allogeneic bone marrow or solid organ transplant
* Administration of a live, attenuated vaccine within 4 weeks prior to enrollment
* Treatment with systemic immunostimulatory agents within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to enrollment
* Treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to enrollment
SafeMedWaste At-Home, Environmentally-Friendly Opioid Disposal Kit for Orthopedic Post-Operative Surgical Patients to Reduce Opioids Available for Diversion

There is an urgent unmet medical need for a cost-effective, environmentally friendly, in-home opioid disposal solution for surgical patients that is clinically proven to reduce opioid use disorder that is substantiated with economic data. SafeMedWaste, Inc. (SMW) has developed the patented SafeMedWaste in-home drug disposal container, that completely destroys opioids within minutes and can be placed in the regular trash, without risk of ground or municipal water contamination.

A pilot randomized clinical trial will evaluate the use of SafeMedWaste in 300 adult patients in outpatient surgery clinics undergoing shoulder and knee surgery.

The trial will evaluate opioid disposal rates and events related to opioid diversion and use disorder in 300 adult patients 18 years of age and older undergoing outpatient knee and shoulder surgery who are prescribed opioids to manage their acute post-surgical pain.

Patients will be randomized into two arms. During the standard of care post op visits (2-, 6- and 10- weeks), when the treating physician has determined that the patient will no longer need opioids to manage their post-surgical pain, all patients will receive general instructions by video on opioid disposal recorded by one of the orthopedic surgeons. Patients in the treatment arm will also be given the SafeMedWaste opioid disposal system and watch an instructional video on how to use the product.

All patients will complete a pre-surgery survey and a post-surgery survey 90 days after surgery. Patients will self-report their disposal or non-disposal of the drugs, documented with pictures uploaded to the patient's MyChart account. Data from the surveys will be statistically analyzed to identify significant factors that influenced patients' behavior vis-à-vis opioid disposal.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

  * Subject is 18 + years of age
  * Subject is opioid naive (within the last 3 months), as evidenced by MyChart patient record or response to medical history questions
  * Subject is scheduled to undergo shoulder and/or knee surgery

Exclusion Criteria:

* Subject has a history of opioid addiction, as evidenced by MyChart patient record or response to medical history questions
* Subject is currently utilizing prescription narcotics for any reason, as evidenced by MyChart patient record or response to medical history questions
* Subject does not have the mental capacity to make their own healthcare decisions
* Subject is unable to provide written consent
Arthritis Research UK Gout Treatment Trial - Phase 2

The purpose of this study is to determine in community-derived patients with gout the effectiveness, and cost effectiveness, of a nurse-led complex intervention that reflects recommended best practice (including patient information concerning gout, its prognosis and its non-pharmacological and drug options).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of gout
* At least one acute attack of gout within previous 12 months

Exclusion Criteria:

- Inability to give informed consent and known terminal or mental illness
Effects of Interdisciplinary Treatment on Sickness Absence in Patients With Chronic Pain

Chronic pain is a globally prevalent condition that causes enormous social costs; largely due to sickness absence. A common intervention for patients with chronic pain problems is interdisciplinary treatment (IDT), which consists of a combination of physical exercise, cognitive behavioural therapy and work training coordinated in an interdisciplinary team. Based on data from Swedish National Registers, this study evaluates the effects of IDT on sickness absence.

This is a completely register-based observational cohort study. The study population is defined from the Swedish Quality Registry for Pain Rehabilitation (SQRP), which routinely aggregates data from specialist IDT pain management clinics across Sweden. SQRP contains information on the exposure/intervention: whether a patient that visited a SQRP-affiliated clinic was allocated to an IDT program (test) or not (control); t0 defined as the day of the IDT assessment. Microdata from SQRP is linked to other Swedish registers via the unique personal identification number held by all Swedish residents. Outcome data is obtained from the Swedish Social Insurance Agency. Registers managed by the National Board of Health and Welfare include data on dispensed prescription pharmaceuticals and specialist health care.

Markov multistate survival-based methods will be used to compare the sickness absence between groups. Specifically, length of stay per sickness absence state (no sickness absence, sick leave, and disability pension) will be compared over five years from t0. Both crude and adjusted estimates will be presented. Adjustment will be made based on our hypothesis about causal relationships and include: history of sickness absence, sociodemographics (age, sex, sociodemographic status), patient disability (emotional distress, everyday interference, and confidence in future improvement), and governmental policy (IDT assessment year and geographical region of IDT clinic).

Eligibility Criteria:
Inclusion Criteria:

* IDT startyear: 2009-2016
* Age 18-60 yeras
* Pain duration of minimum 90 days

Exclusion Criteria:

* Cancer in the previous 5 years
* An IDT assessment in the previous 2 years
* Full or partial disability pension in the year preceding the IDT assessment
Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's Disease

The purpose of this observational study is to determine whether the vaccine (UB 311), targeting the N-terminal amino acids (1-14) of the amyloid beta peptide, has long-term immunogenicity and efficacy in individuals diagnosed with mild or moderate Alzheimer's disease (AD) who previously received UB 311-treatment. Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with mild to moderate Alzheimer's disease who received three (3) injections of UB 311 in the initial Phase I V118-AD trial

Exclusion Criteria:

* Individuals with Alzheimer's disease who are currently on prohibited medications, have severe or uncontrolled systemic disease, or are unable or unwilling to comply with study protocol requirements.
Preoperative Magnetic Resonance Imaging Abnormalities Predictive of Lumbar Herniation Recurrence

There are currently no standard criteria for evaluating the risk of recurrent disk herniation following surgical repair. This study investigated the predictive values of five presurgical imaging parameters, paraspinal muscle quality, annular tear size, Modic changes, modified Pfirrmann's disc degeneration grade, and presence of sacralization or fusion.

Clinical status and MRI findings were evaluated before surgery and 4, 12, and 24 months post-surgery using a Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Short Form 36 (SF36).


Eligibility Criteria:
Inclusion Criteria:

* first operation for a single-level lumbar disk herniation
* no concurrent spinal pathology such as stenosis, spondylolisthesis, or deformity
* complete data on clinical and radiological parameters

Exclusion Criteria:

* the operation was for multi-level pathologies
* recurrent surgery
* exhibited concurrent spinal pathology
* was missing or incomplete clinical and radiological data
Non-heme Iron Absorption From Single Meals of Fava Bean Protein, Beef Protein and Cod Protein

The aim of this study is to investigate the non-heme iron absorption from single meals of texturized fava bean protein, which has been suggested as a protein source suitable for replacement of meat, compared to the non-heme iron absorption from beef protein and cod protein meals. The study participants are women of fertile ages, which is one of the main groups at risk of developing iron deficiency. Since a dietary shift towards increasingly plant based is being pushed, investigating nutritional effects of such a shift is essential to avoid potential negative effects such as an increase of nutritional deficiencies. The study includes two cross-over single-blinded iron isotope trials in apparent healthy Swedish women of the ages 18-45 years, each of whom served as their own control. Participants will be served matched test meals containing beef and fava bean protein (Study 1), or cod and fava bean protein (Study 2) with radiolabeled non-heme iron 55Fe and 59Fe. Absorption of non-heme iron from test meals will be measured by whole-body counting, and erythrocyte incorporation by liquid scintillation.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-45
* Is tolerant to intake of fava bean
* Eats fish and meat
* Feels healthy
* Can eat a breakfast consisting of three potato-based patties

Exclusion Criteria:

* Other sex than female
* Age \<18 and \>45
* Has an ongoing infection
* Is vegetarian
* Is pregnant or lactating
* Takes iron supplements
Kirschner Wires Fixation Versus Cannulated Screws Internal Fixation for Displaced Lateral Condyle Humeral Fracture in Children

Lateral condyle fracture of the distal humerus is the second most common injury around the elbow and accounts for 20% of all the elbow fractures in children.The average age for the fracture involving the lateral condyle is around six years.

There are different treatment options of the lateral condyle fractures include

* non-operative management with plaster cast immobilization for undisplaced or minimally displaced fractures.
* Whereas the fractures displaced \>2 mm need operative management. The objective of treatment in the displaced fracture is to obtain and maintain the articular congruity.

In the operative management, the reduction technique includes open or closed methods.


Eligibility Criteria:
Inclusion Criteria:

* Children up to 14 years.
* closed lateral condylar fracture.
* displacement more than 2mm .
* fracture Less than two weeks of injury.

Exclusion Criteria:

* Patients with open fractures.
* otherassociated injury in the same elbow .
* elbow with preexisting anatomical deformity .
Discontinuation of Levothyroxine Therapy for Patients With Subclinical Hypothyroidism

The investigators propose the following hypothesis: discontinuation of levothyroxine (LT4) for veterans with subclinical hypothyroidism (SCH) will be feasible, acceptable, and safe and will not negatively affect their Quality of Life (QoL). The investigators aim to evaluate the feasibility of LT4 discontinuation among veterans with SCH and determine the changes in QoL measures, lipids, and adverse events.

This is a pilot, randomized, double-blind, placebo-controlled trial.

Methodology:

The investigators will conduct a double-blind, placebo-controlled clinical trial where eligible veterans diagnosed with SCH and on LT4 will be 1:1 randomized to either continue LT4 or change to placebo. The primary outcome is intervention feasibility (willingness to enter the trial, recruitment rate, and completion rate). Secondary outcomes are: 1) changes in QoL measures (Hypothyroid Symptom \[HSS\] and Tiredness scale scores of the Thyroid-Specific Patient-Related Outcome Measure \[ThyPRO\], EuroQoL 5-Dimension Self-Report Questionnaire) measured at baseline, 6-8 weeks and 6 months and 2) changes in lipids assessed at baseline and 6 months, and 3) incidence of adverse events (overt hypothyroidism, hyperthyroidism, atrial fibrillation, fractures, acute myocardial infarction, stroke, acute coronary syndrome, heart failure, mortality).

Eligibility Criteria:
Inclusion Criteria:

* Veterans
* diagnosis of SCH

Exclusion Criteria:

* thyroid-stimulating hormone (TSH) \> 10 milli-international units per liter (mlU/L) (at any point)
* Levothyroxine (LT4) dose more than 75 mcg daily
* use of antithyroid medications, amiodarone, tyrosine kinase inhibitors or lithium
* history of thyroidectomy or radioactive iodine therapy
* LT4 suppressive therapy for thyroid cancer, goiter, or inflammation
* pregnancy or plans for pregnancy in the next 6 months
* an unstable medical condition that would jeopardize safety or interfere with study participation
* severe hypothyroidism-related symptoms
* strong family history of hypothyroidism
* severe dyslipidemia
* hospitalization for major illness within the previous 4 weeks
* acute coronary artery syndrome, acute myocarditis, or pancarditis with the previous 12 months
* grade IV New York Heart Association heart failure
* receiving services from hospice
* lack of decision-making capacity
* terminal medical condition for which life expectancy would be less than 6 months
* not willing to stop LT4
* self-reported non-adherence to LT4 therapy
* abnormal TSH at time of screening for participation (assessed during Baseline Visit)
Improving Neurological Outcome for Acute Basilar Artery Occlusion With Sufficient Recanalization After Thrombectomy by Intraarterial Tenecteplase (INSIST-IT)

The potential benefit of intraarterial tenecteplase in acute basilar artery occlusion (BAO) patients with successful reperfusion following endovascular treatment (EVT) has not been studied. The current study aimed to explore the efficacy and safety of intraarterial tenecteplase in acute BAO patients with successful reperfusion after EVT.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Patients with basilar artery occlusion who received endovascular treatment within 24 hours of estimated time of stroke onset as per BASICS trial definition;
* National Institute of Health Stroke Scale (NIHSS) ≥ 6 before endovascular treatment;
* Successful recanalization (mTICI 2b-3) after endovascular treatment;
* PC-ASPECTS ≥ 6 on CT;
* Absence of parenchymal hematoma on CT images done in the angio suite immediately after the procedure;
* Modified Rankin Scale score before stroke onset ≤ 3;
* Signed informed consent by patient or their legally authorized representative.

Exclusion Criteria:

* baseline PC ASPECTS \< 5 on CT;
* More than six retrieval attempts in the same vessel;
* Hemorrhagic stroke: cerebral hemorrhage, subarachnoid hemorrhage;
* Coagulation disorders, systemic hemorrhagic diathesis, thrombocytopenia (\<100000/mm3), or INR \> 1.7;
* Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
* After recanalization, severe and sustained (i.e., \> 5 minutes) uncontrolled hypertension (systolic blood pressure over 180mmHg or diastolic blood pressure over 105 mmHg) refractory to antihypertensive medication;
* Patients with contraindication or allergic to any ingredient of drugs in our study
* Pregnancy, plan to get pregnant or during lactation
* The estimated life expectancy is less than 6 months due to other serious diseases;
* Other conditions unsuitable for this clinical study assessed by researcher.
1-month vs 12-month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials

Prospective, multicenter, randomized, double-blind, placebo-controlled trials.

A total of 3486 subjects with ACS who met inclusion criteria and do not have any exclusion criterion will be randomized to IVUS- or Angiography-guidance group (first randomization). In the IVUS-guidance group, IVUS will be used to evaluate the lesion's specificity and to measure lesion length, landing zone, and reference vessel diameter prior-to stenting; and to assess stent expansion, extension, apposition, and possible complications after stent implantation. The IVUS- defined criteria for the optimal stent deployment included: 1) the minimal stent area (MSA) in the stented segment is \>5.0 mm\^2, or 90% of the MLA at the distal reference segments; 2) plaque burden 5-mm proximal or distal to the stent edge is \<55%; and 3) absence of \>Type B edge dissection. Further treatment will be required if stenting procedure is defined as suboptimal according to IVUS definition. IVUS will be not allowed to be used in the Angiography-guidance group.

Those patients who have had no death, STEMI, stroke, ST, TVR or major bleeding (BARC 3 or 5) within 30 days and have continued on aspirin and ticagrelor for 30 days without interruption for \>48 hours will be randomized 1:1 to:

1. Ticagrelor plus+ matching placebo for an additional 11 months (SAPT group)
2. Ticagrelor plus aspirin (study drug) for an additional 11 months (DAPT group) Follow-up of all subjects will continue for 1 year with an option for additional follow-up to 3 years.

Eligibility Criteria:
Inclusion Criteria:

Enrollment into the study will require meeting at least one of these clinical syndromes within 1 month.

* Unstable angina, defined as rest pain for 5-30 minutes or deteriorative exertional angina with either a) transient ST segment depression or elevation, or b) angiography showing a visually estimated diameter stenosis ≥90% or a ruptured plaque or thrombotic lesion
* Non-ST elevation myocardial infarction (NSTEMI), defined as positive troponin consistent with clinical syndrome.
* ST elevation MI (STEMI)

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Stroke within 3 months or any permanent neurologic deficit, and prior intracranial bleed, or any intracranial disease such as aneurysm or fistula
* Previous coronary artery bypass graft (CABG)
* Any planned surgery within 90 days
* Any reason why any antiplatelet therapy might need to be discontinued within 12 months
* Severe chronic kidney disease defined as an estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m\^2
* Need for chronic oral anticoagulation (warfarin/coumadin or direct oral anticoagulants)
* Platelet count \< 100,000 mm\^3
* Contraindication to aspirin
* Contraindication to ticagrelor
* Liver cirrhosis
* Women of child-bearing potential
* Life expectancy \< 1 year
* Any condition likely to interfere with study processes including medication compliance or follow-up visits (e.g. dementia, alcohol abuse, severe frailty, long distance to travel for follow-up visits, etc.)
Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta.

Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta. The investigators are looking at EOA and the Pressure Gradients over the valve by patients with the same annulus measured by a hegar dilatator.


Eligibility Criteria:
Inclusion Criteria:

* Aortic valve disease

Exclusion Criteria:

1. Pregnant
2. Breast feeding
3. Aortic valve bigger than 23 mm
4. Endocarditis
5. EF \< 50%
The Effects of Periodontal Therapy on Glycemic Control in Diabetic Patients

Is the non-surgical periodontal therapy can improve glycemic control in type 2 diabetic patients with chronic periodontitis?

The aim of the present study was to monitor the clinical outcomes and the metabolic response of non-surgical periodontal therapy in patients with chronic periodontitis and uncontrolled type 2 diabetes.

Regarding clinical and metabolic parameters at baseline, no differences were displayed between two groups. However, at 3-months follow-up period the patients within a test group were demonstrated better clinical outcomes than patients in a control group

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of diabetes type 2 for more than five years Type 2 diabetes with HbA1c level from 7% to 9% at the last medical evaluation Diagnosis with chronic periodontitis

Exclusion Criteria:

Pregnancy

* Alcoholism and smoking
* Presence of any systemic disorders other than hypertension and diabetes
* Diabetic major complications
Developing an Interdisciplinary Pharmacogenomic Treatment Approach to Reduce Medication Burden and Improve Outcomes

There is no common rule as to how a drug will affect patients. This is due to the effect specific DNA sequences of genes have on drug response, by the effect they have on how medications are metabolized. The primary objective of this research is to optimize medication therapy and to reduce the number of medications used, specifically medications for people with developmental disabilities and co-occuring psychiatric illnesses.

The primary goal of this study is to develop a process for utilizing pharmacogenomic analysis as a strategy to improve the quality of life, safety, decrease medication burden, and enhance the effectiveness of medications in people with psychiatric illnesses and developmental disabilities. Ultimately, this inter-disciplinary service could be developed into a standard screening and consultation tool for healthcare providers to utilize when determining the most appropriate medication for their patients.

Eligibility Criteria:
Inclusion Criteria:

* Current resident of the South Dakota Developmental Center (SDDC)
* Currently taking a high number of medications per month
* Eligibility of the subjects will be determined by the treatment team which consists of 3-4 of the following individuals: treating psychologist, behavior therapist, case manager, supervisors, counselors, dietitians, physician assistants, occupational therapists, and physical therapists

Exclusion Criteria:

* To be determined by the research staff