cyrilzakka/clinical-trials huggingface dataset:
The Association Between Non-vitamin K Antagonist Oral Anticoagulant Concentration and Clinical Outcomes.

Introduction: Non-vitamin K antagonist oral anticoagulants (NOAC) is the first line therapy to prevent ischemic stroke or systemic thromboembolism among atrial fibrillation (AF) patients. Since 2016, our study team enrolled patients under NOAC therapy in National Taiwan University Hospital, and measured their NOAC concentration to develop a cohort of NOAC treatment and NOAC concentration.

Study purpose: Based on the cohort of NOAC therapy, we aim to investigate factors driving high or low NOAC concentration, and link NOAC concentration to clinical outcomes.

Methods: For all the participants in the cohort, we will retrieve their basic characteristic, concurrent medications, laboratory tests and clinical outcomes such as ischemic stroke, systemic thromboembolism, intracranial hemorrhage, major bleeding and death from the electronic medical records. The NOAC concentration will be compared to the expected range reported in clinical trials to define higher, within or lower than expected range. Univariate logistic regression will be used first, followed by multivariate logistic regression to investigate factors associated with high or low NOAC concentration. The relationship between NOAC concentration and clinical outcomes will be investigated by using the Cox proportional hazard model.


Eligibility Criteria:
Inclusion Criteria:

* Age more than 20 years.
* Under NOAC therapy.

Exclusion Criteria:

* Failed to provide at least one blood sample for NOAC concentration measurement.
* Declined to provide informed consent
Quality of Life Study With Adalimumab in Rheumatoid Arthritis

The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.


Eligibility Criteria:
Inclusion Criteria:

* Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
* Subject has a diagnosis of rheumatoid arthritis as defined by the 1987 ACR criteria
* Subjects with treatment failure criteria to Mtx or Mtx + another DMARD

Exclusion Criteria:

* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
* Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months
Perioperative mFOLFOX-6 in Locally Advanced Gastric Cancer

This is a Phase II Trial of Perioperative Chemotherapy with Oxaliplatin, 5-Fluorouracil, Leucovorin(MODIFIED FOLFOX6)in Patients with Locally Advanced Operable Gastric Cancer.

The main purpose of this study is to evaluate response rate (clinical response and pathological response) of oxaliplatin, 5-fluorouracil, leucovorin(MODIFIED FOLFOX6)

Eligibility Criteria:
Inclusion Criteria:

* Previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional LN metastasis are eligible for this study (clinical stage: cT2-4 and N+). At least one measurable regional lymph node metastasis according to the Response Evaluation Criteria in Solid Tumors (RECIST v. 1.0) \[17\] is required. Other eligibility criteria include age between 18 and 75 years, Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1, no prior chemotherapy or radiotherapy, and adequate bone marrow, hepatic and renal function (absolute neutrophil count \[ANC\] ≥ 1.5ⅹ109/L, platelet count ≥ 100ⅹ109/L, total bilirubin ≤ 1.5ⅹupper limit of normal \[ULN\], serum transaminases ≤ 2.5ⅹULN, alkaline phosphatase ≤ 2.5ⅹULN, serum creatinine ≤ 1.5ⅹULN or actual or calculated creatinine clearance ≥ 50 mL/min).

Exclusion Criteria:

* Exclusion criteria include clinical stage T1 tumors, clinical or radiologic evidence of distant metastasis, intestinal obstruction or impending obstruction, active tumor bleeding, interstitial pneumonitis or symptomatic pulmonary fibrosis, peripheral neuropathy of National Cancer Institute Common Toxicity Criteria (NCI-CTC) grade ≥1, pregnant or breastfeeding patients, and other serious diseases.
Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)

This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) \[PR\] treatment in treatment-naïve and prior PR treatment failure participants with chronic Hepatitis C Virus (HCV) genotype (GT)1, GT4, or GT6 infection. The primary objectives are to compare efficacy (assessed by the percentage of participants achieving sustained virologic response 12 weeks after ending study treatment \[SVR12\]) and safety between the grazoprevir plus elbasvir treatment arm and the SOF plus PR treatment arm. The primary hypothesis is that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir treatment arm is non-inferior to that in the SOF plus PR treatment arm.


Eligibility Criteria:
Inclusion Criteria:

* Weigh ≥40 kg and ≤125 kg
* documented chronic HCV GT1, GT4, or GT6 infection
* cirrhosis/absence of cirrhosis defined by liver biopsy, Fibroscan, or FibroSure®
* either treatment naïve or PR Null Responder, PR Partial Responder, or PR Prior Relapser
* participant and partner both agree to use at least use at least 2 effective methods of contraception from at least 2 weeks prior to Day 1 and continue until up to 6 months after last dose of study drug, or longer if dictated by local regulations

Exclusion Criteria:

* has evidence of decompensated liver disease
* is coinfected with hepatitis B virus (e.g. hepatitis B surface antigen positive) or human immunodeficiency virus
* history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy
* has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
* has any of the following conditions: immunologically-mediated disease, organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial, history of chronic hepatitis not caused by HCV
IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS

The purpose of this study is to compare the efficacy of in vitro fertilization (IVF) versus gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).

Women will be randomly divided into two groups; IVF group and gonadotropin group. Women in the IVF group will undergo one full IVF cycle. Women in the gonadotropin group will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.

Eligibility Criteria:
Inclusion Criteria:

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

Exclusion Criteria:

* Age \< 20 or \> 35 years.
* Presence of any infertility factor other than anovulatory PCOS.
* Previous history of ovarian surgery or surgical removal of one ovary.
* Previous exposure to cytotoxic drugs or pelvic irradiation.
* Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
* Metabolic or hormonal abnormalities.
Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine.

A growing body of literature on the cosmetic use of OnabotulinumtoxinA has suggested that the use of preserved saline exerts a local anesthetic effect, and reduces the procedure discomfort when used in reconstitution in lieu of preservative-free saline. However, this has never been studied in chronic migraine.

While reducing discomfort is a desirable target in all procedures, it has a special importance in the use of OnabotulinumtoxinA for chronic migraine due to the numerous injection locations each session (31 sites) and the ubiquity of scalp tenderness in this population. In addition, the pain during procedure is a known migraine trigger for many of these patients.

We hypothesize that preserved saline (known as bacteriostatic saline) produces lower procedure-related discomfort when used as a dissolving solution for OnabotulinumtoxinA in individuals with chronic migraine as opposed to using preservative-free saline.

In addition, we hypothesize that reduction of procedure-relate pain during the injections will also result in reduced migraine/headache attacks in the week immediately following the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of chronic migraine receiving FDA-approved treatment with OnabotulinumtoxinA injection as per standard protocol. Standard protocol consists of 31 injection sites, with total dose ranging from 155 u to 195u.

Exclusion Criteria:

* Subjects whom OnabotulinumtoxinA injections deviate from standard protocol for any reason, such as head/neck infection, head deformity, recent surgery...etc.
Peritoneal Membrane Dysfunction in Peritoneal Dialysis Using Metabolomics

Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis

Ability and sensitivity of metabolomics analysis to highlight biomarkers or a score of biomarkers that will be able to identify those pediatric patients on peritoneal dialysis at high risk for possible peritoneal dialysis complications and mainly encapsulating peritoneal sclerosis. Identification of peritoneal membrane functional status changes over time, at the same patient (cohort study), by metabolomics, aiming in personalized medicine best practice.

Identification of peritoneal membrane functional status changes over time in immature infants' peritoneal membrane.

Identification of early and accurate markers of peritoneal membrane dysfunction when membrane status is possibly reversible that could predict peritoneal patients at risk for future loss of ultrafiltration and dialysis adequacy of small molecules examined today be PET, KT/V and Cr/Cl (when membrane status is not reversible).

Improve PD survival in infants and children.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric and adolescent patients on peritoneal dialysis
* Aged:1month -20 years

Exclusion Criteria:

-Abdominal surgery
Face-to-face Tracheal Intubation: a Comparison of Airtraq, Glidescope and Fastrach

Trauma victims had to be intubated at the scene of area in different conditions. Face-to-face intubation in an entrapped patient is one of these situations. The investigators want to compare the efficacy of Glidescope, Airtraq and Fastrach in simulating face-ro-face intubation in adult patients aged between 18-60 years.

The investigators record the demographic and the airway data of the patients (thyromental distance, sternomental distance, mallampati score, mandibula protrusions, interincisor distance..etc). The hemodynamic data of the patients baseline preoperatively, after induction, after insertion of the device, after intubation, and 2 minutes intervals after intubation during the ten minutes. Cormack-Lehane grade of the videolaryngoscopes, insertion time, intubation time, need of optimisation maneuvers, mucosal damage, teeth and tongue damage, postoperative sore throat, hoarseness, dysphagia were recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years of age
* Elective surgery requiring endotracheal intubation
* Normal airway variables
* BMI\< 30

Exclusion Criteria:

* \< 18 years or \> 60 years
* Emergency procedures
* Known difficult airways
* BMI\> 30
Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers

The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.

Several studies have already showed the interest of the use of NBI for the early diagnosis of malignancies of the upper aerodigestive tract. For all tumors, the most accurate evaluation of its limits is very important to perform the best strategy of treatment. If surgery seems to be the best option, surgical margins must be widely healthy. Despite the systematic transnasal flexible endoscopy with white lamp followed by laryngoscopy under general anesthesia (LGA) and tomodensitometric evaluation, surgical margins can be unhealthy (in situ carcinoma or dysplasia). We propose to evaluate if the use of the NBI could be useful to determine the superficial spread of squamous cell carcinomas in these locations.

To April 2013 to Mars 2015, all patients with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx and whom a LGA are expected, are included. The day before the LGA, two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light and the second one with NBI. All results are noted on a schema. Superficial extension or synchronous lesions showed by NBI are analysed and compared with with lamp technic.

After surgery, surgical margins were evaluated and healthy margins were measured.

Eligibility Criteria:
Inclusion Criteria:

- Patients who can benefit a laryngoscopic exam under general anesthesia

Exclusion Criteria:

* General anesthesia contra-indications
* Local anesthesia allergy
* Breast-feeding period or pregnancy
Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients

This research aims to compare between bandage contact lens and pressure patching in reducing size of erosion area and pain scale in corneal erosion patients as well as its complications.

This is a randomized open-label clinical trial in patients with mechanical corneal erosion. Subjects were selected to use bandage contact lens (Senofilcon A) or pressure patching. All subjects received combination of Polymyxin B, Neomycin, and Gramicidin eye drops and 0,5% Tropicamide eye drops. Evaluation was done 24 hours after treatment

Eligibility Criteria:
Inclusion Criteria:

* aged 17-55 years
* onset of corneal erosion \< 48 hours
* corneal erosion due to mechanical injury
* extensive corneal erosion \> 3 mm2

Exclusion Criteria:

* bilateral corneal erosion
* corneal erosion due to chemical or thermal injury
* history of systemic analgesic use within 1 week prior to the examination or topical analgesics within 1 hour before the examination
* history of systemic or topical antibiotics within 1 week prior to the examination
* other abnormalities due to trauma
* palpebral or eyelashes position abnormalities
* anterior segment infections
* tear break-up time \< 7 seconds in the contra lateral eye
The Effect of Norepinephrine on Cardiac Output in Patients Undergoing Liver Transplant .

Early administration of NE in liver transplant recipient might enhance cardiac output through an increase in cardiac preload .

The derangement of circulatory blood volume in patients with liver cirrhosis makes intraoperative fluid management during liver transplant is challenging . Cirrhotic patients not only have large blood volume but abnormal blood volume distribution, with a substantial fraction of this volume in the splanchnic circulation (. These hemodynamic changes render volume loading in these patients has little impact on CO because a large proportion of infused fluid is shifted to the splanchnic system . In addition, patients with liver cirrhosis is similar to septic patients who have increased total vascular compliance which may cause pooling of blood in venous pool. Several studies in patients with sepsis found that use of low dose vasopressor may convert unstressed blood volume (i.e the amount of blood not causing pressure on the vessels) to stressed volume (i.e additional blood causing a distending pressure on the vascular walls and reflects the effective circulating volume) . However, no previous studies tested the effect of using norepinephrine (NE) on venous return and cardiac preload in patients undergoing liver transplant. An obvious advantage of this possibility is that NE will be used instead of true ﬂuid replacement which may minimize fluid replacement during operation.

Recently, a method was described to estimate the changes in intravascular volume and vascular capacitance by calculating mean systemic ﬁlling pressure (MSFP) . MSFP is the driving pressure in venous return, and it allows calculation of the arterial and venous components of systemic vascular resistance .

Eligibility Criteria:
Inclusion Criteria:

* All Adults (age \> 18 years) patients undergoing living donor liver transplant (LDLT) will be considered for inclusion in the study..

Exclusion Criteria:

* Patients less than 18 years.
* Patients undergoing liver transplantation for acute liver failure .
* All Chronic Hypertensive patients on medication , whether controlled on not controlled
* Those with high risk of post transplant renal dysfunction (serum creatinine \>1.5 mg/dL at time of transplant)
Efficacy of Modification of Lifestyle in the Treatment of Ankylosing Spondylitis: a Pilot Study

Axial spondyloarthritis (axSpA) is a chronic inflammatory immune disorder with a global prevalence that ranges from 20 to 160 cases per 10000 individuals. axSpA has two forms of clinical presentation (radiographic and non-radiographic) based on the presence or absence of radiographic sacroiliitis. This condition mostly affects the vertebral spine, and is characterized by joint pain and stiffness, fatigue, and restricted function, which leads to a substantial physical, psychological, and socioeconomic burden. The clinical management of axSpA needs to combine pharmacological and non-pharmacological approaches to reduce inflammation and improve health-related quality of life.

The aim of the study will be to determine if a 12-week probiotic supplementation will be more effective than an online-delivered strength training program at improving functional capacity in adults with non-radiographic axSpA. As a secondary aim, we will compare the impact of both interventions on disease activity, spinal mobility, quality of life and biochemical measures. This will be the first randomized controlled trial where probiotics are compared with an active intervention.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be aged 18 years or older and have a confirmed diagnosis of non-radiographic axSpA following the 2009 Assessment of the SpondyloArthritis International Society classification criteria

Exclusion Criteria:

* Any systemic disease or comorbidity that may severely impair exercise capacity.
* A high sensitivity C-reactive protein 10-fold greater than the normal upper limit (2.87 mg/l).
* Any changes to medical treatment within the previous 2 months, and having an active peripheral arthritis
Ticagrelor in Fuwai Hospital

This is a single-arm non-interventional cohort study. This study is to describe the contemporary use of ticagrelor in a "real-world" setting, to reflect its acceptance and patients' compliance, and to observe its one-year safety in patients with acute coronary syndrome in Fuwai Hospital.


Eligibility Criteria:
Inclusion Criteria:

1. ≧18 years
2. Established diagnosis of acute coronary syndrome
3. The use of ticagrelor in hospital
4. agree to join this clinical trial and sign informed consent

Exclusion Criteria:

1. Life-expectancy \<1 year
2. Dialysis required
Personalized Prevention for Couples: A 16-month Digital RCT

This couples-based, digital health intervention project is serostatus neutral and seeks to determine efficacy for: a) use and adherence to evidence-based HIV/STI prevention-care strategies; b) creation and adherence to a tailored prevention-care plan; c) creation and adherence to a tailored sexual agreement; and d) improvements in other relationship dynamics among male couples who are in a relationship (defined as greater than 3 months or more).

The project draws on our strong findings from the preliminary work we conducted in the US (R34 pilot randomized control trial \& mixed method acceptability project). The 5-year project will revise and update an existing digital health couples-based HIV/STI prevention toolkit intervention that showed promise for reducing couples' HIV risk. The intervention is theoretically grounded in Couples Interdependence Theory for health behavior change. The project is a 16-month randomized control trial with 375 at-risk male couples using a delayed, educational control condition of 8 months. Our Specific Aims are to: 1) examine efficacy of the intervention on couples' a) formation and adherence to a risk-reduction plan and agreement, b) relationship functioning, c) self-reported and biomarker-confirmed indicators of risk (sexual behavior and STI), and engagement in HIV prevention (PrEP adherence) and care (ART adherence); 2) evaluate use of the intervention over time by using three different data sources; 3) explore moderating and mediating effects on couples' outcomes a-c. The project has high Public Health significance given the HIV disparities and the importance of attending to couples' unique relationship and prevention needs.

Eligibility Criteria:
Inclusion Criteria:

1. assigned male at birth and currently identify as male (cis-gender) or gender queer;
2. has had condomless anal sex (CAS) within the prior 3 months;
3. both partners endorse being in a relationship with one another, defined as "someone you feel emotionally or romantically committed to above all others, and may be referred to as partner, husband, boyfriend etc.";
4. be in a relationship with current partner for at least 3 months;
5. be at least 18 years of age;
6. not have any history of intimate partner violence since relationship began;
7. self-report not feeling coerced by partner to take part in the study activities,
8. has own Internet/web-connected device (e.g. smartphone, laptop, tablet, computer);
9. lives in the U.S. and plans to live in the U.S. for the next 16 months;
10. willing to complete the activities required to obtain and mail back their biomedical data (i.e., self-administer a rapid HIV test (if applicable), willing to use swabs to self-collect their own specimens for STI testing, willing to provide dried blood spot for ART adherence (if applicable), willing to provide dried blood spot for PrEP adherence (if applicable).

Exclusion Criteria:

* Does not meet one or more of the inclusion criteria