cyrilzakka/clinical-trials huggingface dataset:
Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate

Methotrexate (MTX) is the first-line treatment of rheumatoid arthritis (RA). In case of MTX failure, it is discussed to start a Biologic Disease-modifying Antirheumatic Drug (bDMARDs) according to the latest European recommendations of the EULAR. Before to add a Biologic Disease-modifying Antirheumatic Drug (bDMARDs), an objective estimation of MTX impregnation could be carried out by MTX polyglutamates (MTX-PG). In rheumatoid arthritis patients with active disease estimated by DAS28 (Disease activity Score 28)\> 3.2 insufficiently controlled by MTX subcutaneously and patients in remission obtained with a DAS 28 \<2.6 with methotrexate prescribed since more than 6 months at stable dose for at least 3 months, a concentration of MTX-PG will be achieved.

The assumption is the association between low methotrexate erythrocyte polyglutamate and low clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate. Adherence to MTX will be assessed by the Compliance Questionnaire Rheumatology (CQR). Measurement of this adherence could optimize MTX treatment prior to the use of biotherapy which is costly with a lower infectious tolerance.

Correlation between its concentration and compliance assessed by CQR questionnaire will be tested.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and have social security affiliation.
* Patients followed in the Rheumatology Department at the hospital of St Etienne.
* Patients with rheumatoid arthritis and :

  * Either Rheumatoid arthritis patients in remission (DAS 28\<2.6) with MTX treatment for at least 6months, and with a stable dose for 3months.
  * Or patients with a High Disease Activity Rheumatoid Arthritis activity (DAS 28\>3.2) with MTX treatment (≥ 15 mg/weeks), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (≥ 15 mg/weeks) treatment during the previous 3 months.
* Signed informed consent.

Exclusion Criteria:

* Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD)
* Another diagnostic than rheumatoid arthritis
Very Low Calorie Liquid Diet for Pre op Patients

Despite the relative consensus on the benefits of pre-surgical weight loss, i.e., the reduction of comorbidities associated with surgical act, such as decreased visceral fat, liver volume, hemorrhage perioperative and surgical time, the characteristics of the diet to be employed in this period need to be defined more clearly. As there is no description of comparative studies on diet of normal consistency, using solids and liquids, there are doubts as to the real need for consistency liquid diet in preoperative bariatric surgery. The lack of robust evidence has made nutrition professionals adopt different procedures. There is still a belief that these patients are unable to lose weight in the preoperative period, the ongoing history of previous attempts without success.


Eligibility Criteria:
Inclusion Criteria:

* To be clinically severe obese; To be in preoperative phase of bariatric surgery.

Exclusion Criteria:

* Pregnancy and minors under 18 and adults over 60 years of age.
Pilot Study of a Multimodal Prehabilitation Pancreatic Cancer Program

The purpose of this research is to explore the benefits of an exercise and nutrition program during total neoadjuvant therapy (TNT) in preparation for surgery for participants that have pancreatic ductal adenocarcinoma (PDAC)

This research study involves an exercise and nutrition program that will consist of twice weekly exercise sessions and discussion with a nutritionist with possible nutrition supplementation.

The names of the study interventions involved in this study are:

* Exercise Intervention
* Nutrition Intervention

The research study procedures include: screening for eligibility, study evaluations, and follow up visits.

Eligibility Criteria:
Inclusion Criteria

* Adults age 18 years or older.
* Diagnosed within 8 weeks with upfront resectable, borderline resectable, or locally advanced unresectable PDAC as defined by the National Comprehensive Cancer Network (NCCN).
* Planning to undergo TNT at MGH.
* Planning to receive modified FOLFIRINOX for neoadjuvant chemotherapy.
* Planning to undergo surgical resection of PDAC at MGH.
* Verbal fluency in English.

Exclusion Criteria

* Metastatic disease.
* Previous treatment for pancreas adenocarcinoma and no prior therapy for any cancer within 5 years.
* Known history of cognitive or psychologic impairment.
* Known history of physical impairment such as immobility, use of walking aids, or required wheelchair use.
* Known history of the following orthopedic comorbidities: advanced osteoarthritis or rheumatoid arthritis, mobility-limiting amputations, orthopedic injuries, or widespread chronic pain (e.g. fibromyalgia).
* Known history of the following pulmonary comorbidities: severe chronic obstructive pulmonary disease (COPD) defined as FEV1 ≤ 50%, emphysema, interstitial lung disease, and/or use of supplemental oxygen.
* Known history of the following cardiovascular comorbidities: uncontrolled hypertension, severe congestive heart failure (NYHA Class IV), and/or myocardial infarction within the last 6 months.
* Inability to tolerate diet through routine oral routes and/or patients with strict nutritional restrictions, allergies, and/or dietary preferences.
Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with liver metastases.

OBJECTIVES:

* To identify the maximum tolerated dose of stereotactic radiation therapy in patients with hepatic metastases.
* To determine the toxicity and adverse events profile of this patient population.
* To examine patient response, treatment effect on blood chemistry, and hematology values and patient quality-of-life in this patient population.

OUTLINE: Patients are stratified according to stereotactic radiotherapy level (1 vs 2 vs 3) and the number of liver lesions present (1-2 vs 3-5 vs \> 5).

Patients undergo percutaneous placement of metallic fiducial markers within the liver for stereotactic targeting and planning. Patients then undergo 1 fraction of stereotactic radiotherapy within 1 week of the marker placement.

Patients complete Brief Pain Inventory and Brief Fatigue Inventory questionnaires to assess quality of life at weeks 2, 4, 6, 8 and months 3, 6, and 9 after completion of study treatment.

After completion of study treatment, patients are followed for at least 8 weeks.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Metastatic liver lesion ≤ 5 cm in dimension
* Willing and able to undergo percutaneous placement of localization seeds

PATIENT CHARACTERISTICS:

* ECOG performance status 0-1
* Life expectancy ≥ 12 weeks
* Platelet count ≥ 75,000/µL
* Hemoglobin ≥ 9 g/dL
* ANC ≥ 1,500/mL
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* AST ≤ 3 x ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to complete questionnaires alone or with assistance
* No medical, social, or economic circumstance, that is likely to prevent adherence with the protocol

PRIOR CONCURRENT THERAPY:

* No prior radiation therapy to the liver
* No chemotherapy ≤ 4 weeks prior to registration
* Able to safely go without chemotherapy for 4 weeks after stereotactic radiotherapy (e.g., patients must not have or need chemotherapy in the 8 weeks \[4 weeks prior to and 4 weeks after registration\] surrounding stereotactic radiotherapy
A Digital Flu Intervention for People With Cardiovascular Conditions

A 6-month prospective, digital randomized controlled trial targeting approximately 49,000 individuals to evaluate the effectiveness of an influenza vaccination intervention during influenza season for people with cardiovascular conditions


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Resides in the U.S.
* Speaks, reads, and understands English
* Has self-reported being diagnosed with any of the following cardiac conditions below in their Achievement profile:
* Atrial Fibrillation or Afib
* Abnormal or irregular heart rhythm, other arrhythmic heart disease
* Cardiac arrest, or heart attack (myocardial infarction)
* Coronary heart disease like a heart blockage, treated with medications, a stent in the heart, or sometimes bypass surgery-
* Heart failure, like congestive heart failure
* Stroke or cerebrovascular accident (CVA)

Exclusion Criteria:

* Participated in Step 1, Part 2 semi-structured interviews used to obtain feedback on the intervention messages
Cold Snare Polypectomy for Small Bowel Polyps in Patients With Peutz-Jeghers Syndrome

This study aims to evaluate the feasibility and safety of Cold snare polypectomy for removing 5-9mm small intestinal polyps in patients with Peutz-Jeghers Syndrome (PJS),in order to provide some reference for clinical strategy of endoscopic treatment of small intestinal polyps in PJS patients, and may prolong the follow-up period of PJS patients Intervals.


Eligibility Criteria:
Inclusion Criteria:

* Age 8-60, male or female.
* Diagnosed with Peutz-Jeghers Syndrome
* Undergo enteroscopy for small bowel polypectomy.

Exclusion Criteria:

* Absence of at least one study polyp (5-9mm stubby pedicle, wide pedicle and sessile small bowel polyps);
* Be evaluated during enteroscopy for requiring surgical intervention (such as endoscopically difficult to handle giant polyps, intussusception, etc.)；
* With more than 50 polyps ≥1cm found in this enteroscopy examination;
* The polyp has been confirmed to be malignant by pathology, or highly suspicious of malignant transformation under endoscopy;
* Receiving anticoagulant therapy during this treatment;
* Unable or unwilling to provide informed consent.
The Dystonia Coalition Natural History and Biospecimen Repository for Isolated Dystonias

Dystonia is a disorder characterized by excessive involuntary contraction of muscles with repetitive and patterned movements. The isolated dystonias are the most common type of dystonia and include Limb dystonias (like writer's cramp), Cervical dystonia (spasmodic torticollis), Laryngeal dystonias (like spasmodic dysphonia), and Craniofacial dystonias (like blepharospasm). The purpose of this study is to create resources to help learn more about the isolated dystonias, myoclonus dystonia, and dopa-responsive dystonia and to develop and validate various dystonia rating scales.

This collaborative, international effort has one primary goal. This is to create a biospecimen repository and associated clinical database to be used as a resource for dystonia and related disease research. Across sites, the investigators hope to enroll at least 5,000 adult patients.

Subjects of this study will be asked to complete a neurological exam which will be video recorded, complete some questionnaires, and donate a blood sample. A study visit will take between 45 minutes and 1 hour. All subjects will be asked to return every 1, 2, 3, or 4 years for a one hour follow-up visit. People may participate in this study without agreeing to participate in the follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with isolated dystonia or myoclonus dystonia or dopa-responsive dystonia
* To be included in laryngeal dystonia group, nasolaryngoscopy (voice box exam) must have been completed to confirm diagnosis (this voice box exam is not part of the study)

Exclusion Criteria:

* Any evidence of a secondary cause for dystonia (other than myoclonus dystonia or dopa-responsive dystonia)
* Less than 2 months since last botulinum toxin injection
* Inability to provide informed consent
* Significant medical or neurological conditions that preclude completing the neurological exam
* Significant physical or other condition that would confound diagnosis or evaluation, other than dystonia or tremor
Substance Abuse Treatment to HIV Care (SAT2HIV): The Motivational Interviewing-based Brief Intervention Experiment

To test the effectiveness of a single 20-30 minute motivational interviewing-based brief intervention for substance use within HIV/AIDS settings.

The Substance Abuse Treatment to HIV care (SAT2HIV) project, a Type 2 Effectiveness-Implementation Hybrid Trial, seeks to address this gap in services by providing new knowledge regarding the effectiveness of brief intervention (BI) for substance use within community-based HIV/AIDS service settings, as well as new knowledge regarding how to address the well-documented underutilization of evidence-based practices in real-world settings. The specific aims of this project are: Aim 1: To experimentally test the effectiveness of a motivational interviewing-based BI for substance use within community-based HIV/AIDS service organizations, relative to usual care (UC). Aim 2: To experimentally test the effectiveness of adding an organizational-level implementation intervention called Implementation \& Sustainment Facilitation (ISF) to enhance the effectiveness of the implementation strategy currently used by SAMHSA-funded Addiction Technology Treatment Centers (ATTCs; i.e., online introductory training, 2-day training workshop, ongoing feedback and coaching).

Eligibility Criteria:
Inclusion Criteria:

* Have HIV/AIDS.
* Be 18 years of age or older.
* Acknowledges use of at least one substance within the past 28 days and endorse 2+ substance use disorder symptoms during the past 12-months.
* Provide signed and dated assurance of consent.

Exclusion Criteria:

* Are unable to speak English.
* Are unwilling to allow brief intervention sessions to be audio recorded.
* Are unwilling to participate in the study.
Reducing Suicidal Ideation Through Treatment of Nightmares-Post Traumatic Stress Disorder (PTSD)

Patients with PTSD, and frequent nightmares, and mild-moderate suicidal ideation, who are already taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) will be randomized to either prazosin or placebo. The investigators hypothesize that patients receiving prazosin will have a greater reduction in suicidal ideation.


Eligibility Criteria:
Inclusion Criteria:

* PTSD
* Frequent nightmares
* Suicidality

Exclusion Criteria:

* Schizophrenia
* Bipolar
* Substance abuse
An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis

The purpose of this study is to determine whether PF-04383119 is effective in the treatment of pain associated with interstitial cystitis.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults at least 18 years of age;
* Moderate to severe interstitial cystitis, with a mean pain intensity score above a pre-defined level.

Exclusion Criteria:

* Less than 6 months since onset of interstitial cystitis symptoms;
* History of recurrent urinary tract infections, or genitourinary cancer;
* History of hepatitis B, C or human immunodeficiency virus (HIV);
* Use of certain drugs given into the bladder up to 1 month prior to study entry.
Comparison of Calcium Phosphate Cement With Patient-specific Implants for Cranial Reconstruction

Background Cranial reconstruction after monocortical bonegraft harvesting remains a clinical challenge for the maxillofacial surgeon. At present, there is no gold standard technique advised. Patient-specific implants are gaining terrain in the field of craniofacial reconstruction. Comparative studies on differences in success rates between different biomaterials for application in craniofacial surgery are lacking.

Aims The primary objective is to evaluate, in terms of cosmetic result, the postoperative successful outcome of patient-standardized implants for cranial reconstruction after bonegraft harvesting for jaw augmentation of patients with severely atrophic jaw.

Design Patients considered eligible for cranial bone-augmentation of the severely atrophic jaw, that provide their consent for participation in the trial, will be randomized at recruitment into either the patient-specific implant (P) or cement (C) group. In the P group, the cranial bone defect will be reconstructed with a patient-specific implant (KLS Martin, Tuttlingen, Germany). In the C group, the cranial bone defect will be reconstructed with HydrosetTM (Stryker, New Jersey, USA), calcium phosphate cement, according to the current standard practice at the department.

Parameters representing ease of application of the biomaterial , postoperative complication rate, cosmetic and functional outcome will be measured at fixed time-points during surgery and postoperative follow-up. A cone-beam computed tomography (CBCT) scan of both the donor (cranium) and receptor site (jaw) will be taken preoperatively, within 10 days postop, and 6 months post-operatively to measure biomaterial positioning.

Conclusions Systematic reviews demonstrate the need for randomized prospective studies regarding implantable biomaterials used in facial reconstructive surgery. We hypothesize that patient-specific implants provide more user-friendly alternatives to the standard care, with better cosmetic results.


Eligibility Criteria:
Inclusion Criteria:

* patients aged 18 years or older
* patients of all genders
* patients with moderate to extreme bone atrophy of the jaw, caused by periodontitis or edentulism
* patients requiring a full reconstruction (both anterior and posterior region)
* patients receiving their surgery and follow-up care at the AZ Sint-Jan Brugge-Oostende AV
* patients providing written informed consent

Exclusion Criteria:

* - Patients not eligible according to abovementioned criteria
* Patients with severe uncontrolled diabetes
* Patients with contraindications for general anesthesia
* Patients with known allergies to the biomaterials used
* Patients with cranial vault without diploe and/or cranial vault thickness \<3mm, as defined with cone-beam CT
* Patients with previous surgery of the skull region
* Patients with an explicit risk of bleeding from cranial venous structures, as described by the radiologist based on his/her evaluation of the preoperative CBCT
Active Management for Low Back Pain for 6 to 8 Year Old Schoolchildren

The objective is to assess the effectiveness of a prevention campaign promoting active management in shifting beliefs in 6 to 8 year old schoolchildren. Subjects will be taken from a random sample of schools in Majorca, Spain: private, public and concerted. A 10 item questionnaire will be given to all children in that age group, to be answered in class on days 1, 14 and 97. Schools will be randomly assigned to the study and control groups. In the study group the students will get a Back Comic-Book (promotes active management) after the first assessment. The control group will have no other intervention than the questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Students in randomly selected private, public and concerted Majorca schools
* Must be present in class on day of intervention and assessments

Exclusion Criteria:

* Absent from class on day of intervention and assessments
Evaluation of Sodium Bicarbonate to Reduce the Incidence of Contrast Induced Chronic Kidney Injury in Patients With Kidney Disease

Patients with Stage 3B, 4,or 5 Chronic Kidney Disease who are to undergo an angiography procedure with contrast agent will be asked if they are willing to join the trial. If so they will be screened and randomized to receive either sodium bicarbonate or saline before, during and after the contrast media is given. They will be asked for serum samples 1 to 3 days, 7, 30, 90 and 180 days after the procedure to evaluate whether the sodium bicarbonate has reduced the incidence of contrast induced chronic kidney disease by measuring their serum creatinine, as well as whether they have required renal dialysis or other renal replacement therapy.


Eligibility Criteria:
Inclusion Criteria:

* Candidate for angiography
* Stage 3B, 4 or 5 Chronic kidney disease (i.e. eGFR \<=44)
* Either sex over 18 years of age

Exclusion Criteria:

* Pregnant or breast feeding
* On any kidney replacement list
* Gastric tube in place or gastric drainage
* Uncorrected hypoglycemia
Observation Study of the Medication Switch at Patients Treated With Sitaxentan to a Regime Without Sitaxentan

Due to the withdrawal of Thelin (Sitaxentan) in December 2010 all patients with pulmonary hypertension treated with Sitaxentan need to be switched to an alternative therapy. This study will observe in which way the change of medication - in the clinical routine, without exception in charge of the treating physician - affects clinical and laboratory parameters and patient's quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Pulmonary hypertension
* Treatment with Sitaxentan

Exclusion Criteria:

* Inability or unwillingness to give written informed consent
Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus

The mechanism by which vision loss in glaucoma occurs is still unknown, but it is clear that increased Intraocular Pressure (IOP) is a major risk factor. It is also thought that the lamina cribrosa (LC) is a site of primary damage during the pathogenesis of the disease. The changes caused by intraocular pressure (IOP) modulation at the level of the optic nerve head and LC will be evaluated in the present study. Subjects with keratoconus exhibit abnormal collagen properties that can impair their LC behavior. By evaluating their lamina biomechanical response we can advance our understanding on the role of the lamina in glaucoma pathogenesis. A better understanding of the process will ultimately lead to improved detection and management of glaucoma.

It is hypothesized that subjects with keratoconus have an abnormal biomechanical response of the lamina cribrosa in response to IOP modulation.


Eligibility Criteria:
Inclusion Criteria:

Candidates must meet the following inclusion criteria in order to participate in the study.

* Ability to provide informed consent and to understand the study procedures

Keratoconus:

* Clinical diagnosis of keratoconus
* Central thinning of the cornea
* Abnormal posterior ectasia.

Glaucoma:

* Glaucomatous ONH abnormality: rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.
* Two consecutive abnormal SITA standard perimetry tests with GHT outside normal limits.

Exclusion Criteria:

Candidates that meet any of the exclusion criteria at baseline will be excluded from study participation.

* Media opacity (e.g. lens, vitreous, cornea).
* Strabismus, nystagmus or a condition that would prevent fixation.
* Diabetes with evidence of retinopathy.
* Previous intraocular surgery or ocular trauma (with the exception of laser procedures and subjects that have undergone uneventful cataract surgery more than 6 months from enrollment date).
* Neurological and non-glaucomatous causes for visual field damage.
* Any intraocular non-glaucomatous ocular disorders.