cyrilzakka/clinical-trials huggingface dataset:
Trial Combining Pembrolizumab and Cesium 131 Brachytherapy With Salvage Surgery in HNSCC

To Study Perioperative PD-1 Inhibitor and Cesium-131 Interstitial Brachytherapy in patients with locally recurrent HNSCC eligible for salvage surgery.

This study is a non-randomized, single-arm, multi-institutional phase 1b/II study including patients with locally recurrent head and neck cancer eligible for resection. Patients who are identified to be eligible for surgical resection will be screened and consented to receive one 200mg IV dose of pembrolizumab followed by salvage surgery. At the time of surgery, they will have Cesium131 seeds implanted. Two to six weeks after surgery, subjects will be started on 200 mg IV of pembrolizumab to be continued every 3 weeks for 6 months. The phase 1b part will enroll 3 patients for a safety run-in, followed by the phase 2 part if no DLTs are seen in these 3 patients. Phase 2 will be used to estimate the 2-year DFS in comparison to a benchmark selected based on a historical control. For correlative studies, archived tissue and surgical specimen will be evaluated by H\&E and IHC for immune phenotype. Blood samples will also be collected as shown in schema above for correlative studies (blood will be collected for correlatives and biomarkers before and after the first of pembrolizumab, before starting adjuvant pembrolizumab and at completion of 6 month course of adjuvant pembrolizumab). Patients will be followed approximately every 3 weeks during treatment for the first 6 months, then monthly for 3 months following treatment and then every 3 months thereafter for 24 months for disease free survival (DFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* locally recurrent HNSCC and be eligible for salvage surgery
* If patient received radiation therapy in the past, they should have recovered from the acute toxicity to \<grade 1
* tumor needs to be deemed resectable

Exclusion Criteria:

* Exposed carotid artery preoperatively requiring sacrifice or bypass intra-operatively
* Patients with active pharyngo-cutaneous
* Patients with more than one site of distant metastatic disease
* Prior immune-based anticancer therapy within last six months
Intramedullary Resorbable Fixation System Versus K-wire for the Treatment of Lesser Toe Deformities

Hammertoe deformity is one of the most common deformities in the foot and is characterized by dorsiflexion of the proximal phalanx at the metatarsal-phalangeal joint and a plantarflexion of the middle phalanx at the proximal interphalangeal joint. Surgical intervention for this type of deformity is indicated when the symptoms progress and conservative treatments are not enough, that is, when we are faced with a rigid painful deformity.Arthrodesis of the proximal interphalangeal joint temporarily fixed with a Kirschner wire is the most commonly used techniques.

Therefore, intramedullary fixation with a PLLA needle may be a good alternative. The use of biomaterial is gaining relevance in foot surgery, with polylactic acid being the most widely used due to its strength. Its total biodegradation requires a time of 16-24 months. No cases of foreign body reaction have been described with this type of osteosynthesis material, due to its characteristics similar to those of bone. Its only drawbacks are that it increases the complexity of the technique and that it increases the cost of the procedure. Being a flexible needle, it allows to leave a functional intraoperative claw. It maintains the functionality of the distal interphalangeal joint and carries a lower risk of infection by carrying osteosynthesis material on the outside.

The purpose of the present study is to prospectively collect clinical and radiographic outcomes of operative correction of hammertoe deformity using a fixation system of intramedullary device of polylactic acid versus a kirschner wire.

A comparative, prospective, randomised study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and radiological evidence of rigid hammer toe.
* Non-smoking patient.
* Have no previous surgical episode or known trauma to the foot or ankle of the same limb.
* Not have any significant medical comorbidity:
* Uncontrolled hypertension.
* Previous myocardial infarction.
* Neoplasms.
* Chronic obstructive pulmonary disease.
* Arrhythmias.
* Morbid obesity.
* Uncontrolled diabetes mellitus.
* Peripheral vascular disease.
* Peripheral neuropathy.
* Lumbar disc herniation.
* Any neuro-muscular alteration.
* That the patient present:
* Palpable peripheral pulses through the posterior tibial artery and pedia.
* Ankle-brachial index or YAO between 1-1.2.
* Partial oxygen saturation\> or = 95%.

Exclusion Criteria:

* That the patient has undergone another previous surgical procedure on the same foot.
* Known trauma to the foot to be intervened.
* History of sensitivity to local anesthetics.
* Pregnant or lactating women.
* Follow-up time less than 90 days.
* Patients with any systemic pathology or in chronic treatment that could interfere with the favorable evolution of the process.
MalnutritiOn Assessment With biOelectrical impedaNce Analysis in gastRic Cancer patIentS Undergoing Multimodal trEatment

The aim of this single-arm prospective, multicenter, cross-sectional study is to evaluate the nutritional status and body composition on tumor regression grade with bioelectrical impedance analysis in gastric cancer patients undergoing multimodal treatment. Results of this study will reveal whether nutritional status and body composition assessment based on bioelectrical impedance analysis will become a validated and objective tool to support clinical decisions in gastric cancer patients undergoing multimodal treatment.

Up to 20% of gastric cancer patients experience unintentional loss of their pretreatment body weight. Malnutrition contributes to increased morbidity, higher risk of perioperative complications and systemic toxicity. A standardized approach to evaluate the nutritional status of gastric cancer patients is yet to be established. Bioelectrical impedance analysis is a non-invasive technique estimating changes in body composition over time.

125 patients with locally advanced gastric adenocarcinoma scheduled for multimodal treatment will be included in the study. Four consecutive nutritional status assessments will be performed throughout the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma)
3. Stage II - III disease (cT2 cN+ and cT3-T4 cN+/-) based on the 8th edition of TNM classification
4. Qualification for multimodal treatment by the decision of the multidisciplinary tumor board

Exclusion Criteria:

1. Early gastric cancer (cT1N0-3M0) scheduled for endoscopic treatment by multidisciplinary team
2. Gastric stump carcinoma
3. Distant metastasis
4. Upfront surgery
5. Other malignancies
6. Contraindications to bioelectrical impedance analysis (e.g., implanted cardiac devices, metal implants or pregnancy)
A Smartphone Application to Improve Medication Adherence Among People With Type 2 Diabetes Mellitus in Singapore

Background: Diabetes mellitus (DM) is a major cause of morbidity and mortality worldwide. Long-term glycemic control is important to prevent or delay the onset of DM related complications. Patients often fail to achieve optimal glycemic control from pharmacotherapy due to non-adherence. With the high prevalence of smartphone usage locally and among the developed countries, there has been a growing interest to deliver interventions through mobile applications. In this study, a mobile application targeted at improving medication adherence among people with Type 2 DM will be developed and evaluated.

Aims: This study aims to (i) design a smartphone application to improve medication adherence and (ii) evaluate its impact on clinical outcomes, health-related quality of life (HRQoL) and health status among patients with Type 2 DM.

Hypothesis: The use of a smartphone application can improve medication adherence among patients with Type 2 DM, as well as clinical outcomes, HRQoL and health status.

Methods: This is a randomized, open-label controlled trial involving patients with Type 2 DM managed at Singapore General Hospital. Patients seen at the institution's Diabetes Centre and those referred to the pharmacist-led Medication Therapy Management service are eligible to participate. Patients in the intervention group will have the mobile application downloaded onto their smartphones, while those in the control group will receive the usual standard of care. The primary outcome will be change in self-reported medication adherence, determined using the 8-item Morisky Medication Adherence Scale. Secondary outcomes include change in HbA1c, blood glucose, frequency of dose titrations, addition or removal of oral hypoglycemic agents, HRQoL (measured using the Audit of Diabetes Dependent Quality of Life) and health status (measured using the EuroQol-5D-5L and EuroQol Visual Analogue Scale). All outcomes will be measured at baseline and at the end of the 6-month study period (± 4 weeks).

Significance: The development and evaluation of a mobile application to improve adherence among patients with Type 2 DM in Singapore is the first of its kind, and the findings of this study will provide the much-needed evidence to demonstrate the effectiveness of this intervention.


Eligibility Criteria:
Inclusion Criteria:

* Existing Type 2 DM managed at SGH Diabetes Centre and those referred to the pharmacist-led MTM service
* Age≥ 40 years
* HbA1c≥ 8.0
* Suspected non-adherence (e.g. admitted to have missed doses, HbA1c not at target despite frequent dose titrations, recent DM related hospitalization/ emergency visit)
* Owns a iOS smartphone with Wi-Fi or data plan

Exclusion Criteria:

* Unable to manage own medications (e.g. taken care of by caregiver, nursing home patients, cognitive impairment)
* Unable to read and comprehend English
* Physical impairment that precludes the use of smart phone functions (e.g. deformed finger joints, amputation)
Extension to a Randomized, Double-blind, Placebo Controlled Study of LCQ908 in Subjects With Familial Chylomicronemia Syndrome.

This study was to determine long-term safety and tolerability, and continued efficacy in lowering triglycerides of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS) (HLP type I).

This study was an 52 weeks open label extension starting at the lowest treatment dose used in CLCQ908B2302/NCT01514461 (i.e., 10 mg) with optional up-titrations, to evaluate the overall long-term safety and tolerability of LCQ908 in patients with Familial Chylomicronemia Syndrome, who either discontinued from the CLCQ908B2302/NCT01514461 study (due to tolerability issues) or completed the CLCQ908B2302/NCT01514461 study after 52 weeks. In addition, patients who had previously completed study CLCQ908A2212/NCT01146522 were eligible to participate.

Following Protocol amendment 2, the original 52 week duration of this study (CLCQ908B2305) became Part A of LCQ908B2305 and a 78 week extension became Part B. However, following Protocol amendment 3, Part B was ended at the same time as the last patient of Part A completed 52 weeks. The reason for termination of Part B was the findings from the December 2014 interim analysis which suggested that the size of benefit that was anticipated from continued participation of patients in the 18 month extension trial (Part B) no longer supported trial extension beyond Part A.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Subjects that either discontinue prematurely or complete the CLCQ908B2302 study after 52 weeks or FCS subjects who have previously completed study CLCQ908A2212.

Exclusion Criteria:

1. Subjects discontinued from the CLCQ908B2302 study for serious, potentially study drug related adverse events.
2. Subjects from the CLCQ908B2302 study who have developed any other contraindication to participation (for example, renal failure)
3. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
5. Subjects with type 1 diabetes mellitus or type 2 diabetes mellitus if HbA1C is ≥ 8.5%.
6. Treatment with fish oil preparations within 4 weeks prior to randomization.
7. Treatment with bile acid binding resins (i.e., colesevelam, etc) within 4 weeks prior to randomization.
8. Treatment with fibrates within 8 weeks prior to randomization. Washout may occur following screening if required.
9. Glybera \[alipogene tiparvovec (AAV1-LPLS447X )\] gene therapy exposure within the two years prior to screening.
10. eGFR \<45 ml/min/1.73m2 or history of chronic renal disease.

Other protocol defined inclusion/exclusion criteria may apply.
Human Milk Fortifier and Cytokine Profile

This is a research study investigating if adding human milk fortifier to a preterm babies breast milk feedings affects the baby's immune system.

In very low birth weight (VLBW) infants and preterm infants human milk fortifier (HMF) is often added to breast milk feedings in order to add extra calories, vitamins, and minerals. It is well known that breast milk feedings are easier to digest and have immune benefits compared to formula feedings. Cytokines, marker of immune function, can be found in blood, stool, and breast milk. This study involves collection of blood and stool samples to monitor cytokines. The purpose of this study is to understand whether human milk fortifier alters infants' cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Infants born weighing less than 1500 grams
* exclusive breast milk feedings with intention to fortify with human milk fortifier

Exclusion Criteria:

* positive blood culture
* history of necrotizing enterocolitis
* significant lung disease at the start of the study
Pathophysiological Mechanisms of Dyspnea and Activity-limitation in Mild Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease (COPD) is a growing cause of death, disability and health care costs in Canada. Nevertheless, COPD remains largely under-diagnosed and under-treated, particularly in its early stages. Patients with mild COPD have variable respiratory symptoms and often go unrecognized by their caregivers. Recent studies indicate that even smokers with near normal breathing test results can have extensive small airway disease/dysfunction at rest, which becomes more pronounced during the stress of exercise thus leading to unpleasant breathing difficulty. This study seeks to better understand the nature and causes of breathing discomfort and activity limitation in a group of patients with mild COPD. The investigators will compare detailed tests of small airway function and conduct an evaluation of several key physiological parameters during the stress of exercise in patients with mild COPD and in healthy, age-matched, non-smoking control subjects. The investigators will also compare detailed physiological responses to exercise under conditions of chemical loading and mechanical unloading of the respiratory system in patients with mild COPD.

The proposed study will be the first to systematically test the hypothesis that pathophysiological abnormalities in ventilatory demand, pulmonary gas exchange, small airway function, dynamic ventilatory mechanics and respiratory muscle function contribute significantly to exertional dyspnea and activity-limitation in patients with mild COPD. This study will be the first to determine if these abnormalities can be manipulated.


Eligibility Criteria:
Inclusion Criteria:

* Post-bronchodilator forced expiratory volume in 1 sec (FEV1) ≥ 80%predicted and a FEV1/forced vital capacity (FVC) ratio \< 0.70;
* Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospitalizations in the preceding 6 weeks;
* A cigarette smoking history ≥ 20 pack-yrs;
* Body mass index between 18.5 and 30 kg/m2;
* Able to perform all study procedures and provide informed consent.

Exclusion Criteria:

* A diffusing capacity of the lung for carbon monoxide (DLCO) \< 40 %predicted;
* Presence of active cardiopulmonary disease (or comorbidities) other than COPD that could contribute to dyspnea and exercise limitation;
* Clinical diagnosis of sleep disordered breathing;
* History or clinical evidence of asthma;
* Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s);
* Use of daytime oxygen or exercise-induced arterial oxygen desaturation to \<80% on room air.
Impact of Physician Directed Education on Patient Compliance With Hepatitis C Therapy

The purpose of this study is to evaluate the impact of a physician directed education program on treatment compliance of hepatitis C patients administered triple drug therapy of pegylated interferon, ribavirin and boceprevir.

The new treatment paradigm for HCV in the era of protease inhibitors will add a level of complexity that was previously not seen with pegylated interferon and ribavirin. In addition to new concepts such as utilization of a lead-in period, compliance with a TID dosing regimen of a third agent, development of resistance, and futility rules and decision points have yet to be assessed in a real life practice setting. The OPTIMAL trial is designed to evaluate the impact of an education program for community sites participating in a CLDF study treating chronic HCV genotype 1 patients. Group A will be comprised of approximately 30 CLDF designated Hepatology Centers of Educational Expertise (HCEE) and Group B will be comprised of approximately 60 community sites. Group A will also deliver the educational program regarding the use of HCV protease inhibitors, and the overall treatment of HCV to approximately two (2) community sites in it's geographic region. Group B will be comprised of community sites that have no previous clinical trial experience with boceprevir or an HCV protease inhibitor. For the purpose of this study, each community site in Group B will be assigned to an HCEE.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Hepatitis C (HCV) genotype 1
* Detectable HCV-RNA within 180 days of screening
* Age ≥ 18 years
* Weight \> 40 kg
* Patient and partner(s) must agree to use acceptable methods of contraception
* Written informed consent

Exclusion Criteria:

* Known co-infection with HIV or HBV
* Previous interferon or ribavirin regimen requiring discontinuation for an adverse event considered related to ribavirin and/or interferon
* Currently taking or planning on taking any prohibited medications
* Evidence of decompensated liver disease including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy
* Diabetes and/or hypertension with clinically significant ocular examination findings
* Pre-existing psychiatric condition(s)
* History of severe and uncontrolled psychiatric disorders
* Active alcohol or drug abuse (not including marijuana)
* Pre-existing medical condition that could interfere with the patient's participation in the study
* Chronic obstructive pulmonary disease
* Abnormal lab values
Organosilane for Surface Cleaning in Intensive Care Units

The purpose of this study is to evaluate if surface disinfection with organosilane associated with traditional cleaning reduces the incidence of healthcare-associated infections (HAIs) in intensive care units when compared with traditional cleaning alone.


Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 years and older who will be admitted to the participating ICUs

Exclusion Criteria:

* Patients under 18 years
* ICUs that may use any organosilane formulation for surface disinfection
Posterior Capsule Opacification and Optical Quality of Different Hydrophobic Acrylic Intraocular Lenses

The most frequent long-term complication of cataract surgery remains to be posterior capsule opacification (PCO). During the past decades many new intraocular lenses (IOL) with optimized lens material and design were introduced. We propose a study comparing three acrylic single-piece IOLs with different design and hydrophobic material. All IOLs (Hoya NY-60, HOYA Surgical Optics GmbH; EyeCee One, Nidek Co., Aichi, Japan) are commercially available and are used for routine cataract surgery. In this study a comparison of PCO score of all two IOLs, a comparison of optic quality with wavefront analyses, visual acuity, contrast sensitivity, IOL decentration and tilt, slitlamp examination, fibrosis, glistening intensity (subjectively scored), YAG capsulotomy rate, and safety parameters (IOL related adverse reactions) of the investigated IOLs will be performed. Since PCO develops slowly within years, a long-term follow-up of three years will be necessary.

As those IOLs are currently often implanted IOLs, their performance on PCO development and their optical quality is of high interest for the ophthalmologic community.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral age-related cataract for which phacoemulsification extraction and posterior IOL implantation has planned
* Age 40 and older
* Visual potential in both eyes of 20/30 or better as determined by investigators estimation
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant

Exclusion Criteria:

* Preceding ocular surgery or trauma
* Relevant other ophthalmic diseases (such as pseudoexfoliation, retinal degenerations, etc.)
* Uncontrolled systemic or ocular disease
Prognostic Impact of Programmed Death Ligand-1 Expression in Advanced Endometrial Cancer

The aim of this study was to assess the frequency of PD-L1 expression in stage III-IV ECs and to investigate its correlation impact with progression-free survival (PFS), and clinicopathological features including microsatellite instability and quantified stromal and intraepithelial tumor-infiltrating CD8+ lymphocytes (TILs)


Eligibility Criteria:
Inclusion Criteria:

* All patients consecutively enrolled from January 2004 to December 2014 treated for Endometrial cancer
* Stage III-IV endometrial cancer with available tissue blocks, including biopsies, hysterectomy specimens and resections of metastatic foci

Exclusion Criteria:

* A patient record captured outside the time frame from January 2004 to December 2014
A Study to Evaluate Patient Characteristics and Treatment Patterns Among Rheumatoid Arthritis Patients

This is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among Rheumatoid Arthritis patients initiating treatment comparator groups of interest between January 2014 and September 2016 across three United States insurance claims databases.


Eligibility Criteria:
Inclusion Criteria:

* first pharmacy claim for Tofacitinib and then Etanercept or Adalimumab between Jan 2014 and Sep 2016 represents the index claim
* First, select patients receiving ≥1 Tofacitinib pharmacy claim (Jan 2014-Sep 2016) who did not have a Tofacitinib claim anytime prior to index
* Patients do have \>1 advanced therapy filled on index date
* Physician diagnosis of Rheumatoid Arthritis (in any position) during the 1-year pre-index period, or on the index date
* Age 18+ years at index

Exclusion Criteria:

-None