Kornimate/medical-research-clean huggingface dataset:
the relationship of cervical sagittal parameters with pain and disability in cervical myofascial pain syndrome

Conditions: Myofascial Pain Syndrome; Neck Pain; Neck Disorder

Summary: participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome will be included in the study. cervical sagittal parameters, numerical pain rating scale, bournemouth neck questionnaire and cervical range of motion will be measured and evaluated.

it is an observational, cross-sectional study. participants between the ages of 18-64 who were diagnosed with cervical myofascial pain syndrome, who applied to the physical medicine and rehabilitation clinic of kanuni sultan süleyman training and research hospital with neck pain for more than 3 months will be included. the pain level of the participants will be evaluated with the numerical pain rating scale, the cervical range of motion and the disability level with the bournemouth neck questionnaire. c0-2 cervical lordosis angle, c2-c7 cervical lordosis angle, cervical sagittal vertical axis (csva), t1 slop, t1 slop - cervical lordosis angle (ts-cl), cervical tilt, thoracic inlet angle (tia) and cranial tilt measurement will be performed by using surgimap software program. the relationship between the level of pain and disability, and cervical sagittal parameters will be evaluated.

Eligibility criteria:
inclusion criteria: * age at 18-64 years * neck pain due to myofascial pain syndrome for more than 3 months * presence of lateral cervical radiograph taken in neutral position in the last 3 months * visible lower border of t1 vertebra on lateral radiographs * absence of other spinal pathologies such as underlying scoliosis, cervical disc herniation, spondylolysis, spondylolisthesis exclusion criteria: * presence of an organic pathology that will cause neck pain * inability to see the lower border of the t1 vertebra on lateral cervical radiographs and the radiographs not taken in neutral position

Keywords: sagittal alignment myofascial pain syndrome neck disability pain intensity
the use of proton pump inhibitor for the treatment of non-erosive gastro-oesophageal reflux disease in chinese population

Conditions: Gastroesophageal Reflux

Summary: the purpose of this study is to evaluate the efficacy of proton pump inhibitor for the treatment of non-erosive reflux disease (nerd) in chinese population. studies from the western population have estimated a worldwide prevalence of gastro-oesophageal reflux disease from 10 to 20 %. monthly symptoms of heartburn or acid regurgitation were found in 9.3% of subjects according to a population survey in hong kong. most of these patients did not show evidence of erosive change during upper endoscopy. however, patients with nerd suffer from similar impairment of quality of life as patients with erosive oesophagitis and their symptoms are as severe as patients with erosive disease. data on the use of proton pump inhibitor for the treatment of nerd in chinese patients are scanty. thus we want to perform a double-blind randomised placebo-controlled study to evaluate the efficacy of proton pump inhibitor for the treatment of nerd in chinese population.


Eligibility criteria:
inclusion criteria: * ambulatory patients with age between 18 -80 years old, * patients with predominant symptoms of heartburn or acid regurgitation at least once weekly with no evidence of endoscopic pathology. exclusion criteria: * patients under 18 or over 80 years of age, * symptoms of gastrointestinal bleeding, * patients who had previous upper gastrointestinal surgery, * patients with concomitant serious medical diseases, * patients who had received h2-receptor antagonists or proton pump inhibitors in the past 4 weeks, * pregnant or lactating women.

Keywords: non-erosive reflux disease
laparoscopic bariatric surgery: two regimens of venous thromboprophylaxis: prospective randomized study

Conditions: Morbid Obesity; Pulmonary Embolism

Summary: obese patients undergoing bariatric surgery warrant vte prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. however, a consensus does not exist on the most effective prophylactic approach.

two regimens of prophylaxis are supposed , the 1st one is to give enoxaparin 40mg 2 hours before surgery and continued daily for 10 days after, and the 2nd one is to start 12 hours before surgery and continued in the same way like the 1st one.

Eligibility criteria:
inclusion criteria: * bmi \>40 or \>35 with comorbidities exclusion criteria: * no

Keywords: morbid obesity laparoscopic surgery compression ultrasonography pulmonary embolism bleeding
lifitegrast 5% ophthalmic solution and contact lens dryness

Conditions: Contact Lens; Contact Lens Discomfort; Contact Lens Dryness

Summary: the most common reason for contact lens discontinuation is contact lens discomfort. the investigators believe that inflammation plays a role in contact lens discomfort and the use of lifitegrast 5% ophthalmic solution may reduce end of the day contact lens discomfort. this study will enroll 21 contact lens users who will be receiving lifitegrast 5% ophthalmic solution and monitor the contact lens discomfort for a 8 week period while.

contact lens discontinuation is mostly associated with ocular discomfort. most patients identifying dryness as the primary reason for contact lens discontinuation. patients often resort to contact lens solutions, lubricating and/or rewetting drops to temporality improve their contact lens wearing experience. clinicians often resort to changing contact lens designs, solutions and wearing modalities to improve comfort. contact lens discomfort is believed to be mediated by many factors including inflammation and very similar in clinical symptoms of dry eye disease and symptoms of dryness. lifitegrast 5.0% ophthalmic solution is an fda approved solution for the management of signs and symptoms of dryness of dry eye disease. studies have shown lifitegrast 5% ophthalmic solution may work by blocking the interaction between icam-1 and lfa-1 leading to a decrease in activation and recruitment of t-cells, an initial step in inflammation. the safety and efficacy of xiidra has been studied in four, 12 week clinical trials involving over 2,100 patients for signs (https://www.xiidra-ecp.com/efficacy-treating-signs) and symptoms (https://www.xiidra-ecp.com/efficacy-symptom-improvement). the purpose of this open label, interventional study is to examine the effect of lifitegrast 5% ophthalmic solution in contact lens wearing experience by using the cldeq-8.

Eligibility criteria:
inclusion criteria: 1. agree with study protocol 2. provide informed consent 3. age 21 or over 4. previous 10 months history of self-assessed comfortable wear samfilcon a contact lenses exclusion criteria: 1. unable or unwilling to comply with study protocol 2. unable of unwilling to provide informed consent 3. self-reported symptomatic intolerance of contact lenses 4. history of an active anterior segment, eyelids, eyelashes, corneal or conjunctival pathology, ongoing ocular infection, inflammation or any other ocular problem that would require management with additional topical ophthalmic medications. 5. have had a history of corneal surgery (corneal transplants, lasik, prk). -

Keywords: keratoconjunctivitis sicca dry eye disease eye dryness
adults with sma treated with nusinersen

Conditions: Spinal Muscular Atrophy

Summary: this is a single center, 22-month observational study of nusinersen treatment in adult patients with spinal muscular atrophy (sma). there will be a total of seven visits. nusinersen is provided as standard of care and not considered research in this study. information will be collected regarding the general health, and function including muscle strength of, as well as any positive and/or adverse events experienced by the study participants.

this is a single center, 22-month observational study of nusinersen treatment in adult patients with sma. there will be a total of five visits. all subjects will be evaluated at a screening visit no more than four weeks before starting their standard of care nusinersen treatment to determine their eligibility for participation. eligible patients will complete their standard induction intrathecal nusinersen treatment on day 1, 15, 29 and 60 followed by maintenance doses every four months. subjects will be reevaluated after completing the loading doses at 2 months followed by every four-month evaluations for the total duration of the treatment of 22 months. currently, there is no data published on patients receiving this treatment over the age of 18. without published data collected from research, it is difficult for adult patients to get approval from their insurance companies to receive this treatment. this study hopes to collect data, in order to make this treatment option easier for patients with sma to access and in general learn how well nusinersen is working in adult patients with sma overtime.

Eligibility criteria:
inclusion criteria: 1. age 18 to 60 years 2. genetic confirmation of 5q sma documented by the homozygous deletion of both smn1 genes on standard genetic tests for the disorder 3. smn2 copy number of 3 or greater 4. subjects must be able to walk thirty feet without assistance (i.e. no canes, walkers) 5. interest in participating and the ability to meet the study requirements 6. women of childbearing-age are required to be on birth control or abstain while participating in the research study exclusion criteria: 1. subjects with history of spinal disease that will interfere with the lumbar puncture procedure 2. subjects with history of bacterial meningitis or encephalitis 3. subjects with history of use of investigational drug treatment for sma in the last six months, or plan on enrolling in any other treatment trial during the duration of this trial 4. history of treatment with gene therapy, stem cell or antisense oligonucleotide 5. patients with co-morbid conditions that preclude travel, testing or study medications 6. patients who are, in the investigator's opinion, mentally or legally incapacitated from providing informed consent for the study, or are otherwise unable to meet study requirements or cooperate reliably with study procedures, especially strength testing 7. women who are pregnant or who intend to become pregnant while participating in the research study or who are breastfeeding

Keywords: nusinersen spinraza
improving outcomes in cardiac arrest with inhaled nitric oxide

Conditions: Cardiac Arrest

Summary: sudden cardiac arrest (ca) is a leading cause of death worldwide. ca claims the lives of an estimated 300,000 americans each year. despite advances in cardiopulmonary resuscitation (cpr) methods, only approximately 10% of adults with ca survive to hospital discharge, and up to 60% of survivors have moderate to severe cognitive deficits 3 months after resuscitation. most of the immediate and post-ca mortality and morbidity are caused by global ischemic brain injury. the goal of this grant application is to test the hypothesis that resuscitation from cardiac arrest can be improved by improving cerebral oxygenation through inhalation of nitric oxide. this strategy will also improve the chances of return of spontaneous circulation (rosc), improve short-term survival and neurologic outcome.


Eligibility criteria:
inclusion criteria: 1. age 18 years and above 2. in-hospital cardiac arrest as defined by cessation of heartbeat 3. presence of endotracheal tube exclusion criteria: 1. age below 18 years 2. absence of endotracheal tube 3. patients with out-of-hospital cardiac arrest 4. patients involved in trauma and/or patients in the sicu or cticu 5. preexisting intra-cerebral lesions such as any head injury (old or new), brain hematoma, cerebral hemorrhage or known frontal lobe disorders such as tumors 6. any patient with a terminal condition that cannot be treated (specifically any terminal malignancy, end stage lung fibrosis, chronic heart failure with an ejection fraction \<20%) 7. patients with do not resuscitate and/or do not intubate (dnr/dni) status 8. therapeutic window has passed
efficacy and safety study of saxagliptin + metformin immediate release (ir) versus metformin ir alone in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to compare the reduction in hemoglobin a1c (a1c) for participants taking saxagliptin in combination with metformin immediate release (ir) versus metformin ir alone.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * 18-78 years of age * taking stable twice daily (bid) dosing of metformin ir (at least 1500 mg) for at least 8 weeks * a1c: 7-10% * c-peptide: ≥ 0.8 ng/ml * body mass index (bmi): ≤45 kg/m\^2 exclusion criteria: * women of childbearing potential unable or unwilling to use acceptable birth control * women who are pregnant or breastfeeding * fasting plasma glucose (fpg) \>270 mg/dl * significant cardiovascular history * symptoms of poorly controlled diabetes * history of diabetic ketoacidosis or hyperosmolar nonketotic coma * insulin therapy within one year of screening * cardiovascular even within the prior 6 months * new york heart association stage iii/iv congestive heart failure and/or known left ventricular ejection fraction \<=40% * significant history of renal or hepatic disease * history of a psychiatric disorder, alcohol or drug abuse within the previous year * treatment with potent cyp3a4 inhibitors or inducers * immunocompromised participants * active liver disease or clinically significant abnormal hepatic, renal , endocrine, metabolic, or hematological screening tests
xvivo heart perfusion system (xhps) with supplemented xvivo heart solution (sxhs)

Conditions: Heart Failure; Transplant; Failure, Heart

Summary: the purpose of this study is to evaluate if non-ischemic heart preservation (nihp) of extended criteria donor hearts using the xvivo heart preservation system (xhps) is a safe and effective way to preserve and transport hearts for transplantation.

preserve heart study - this is a prospective, multicenter, non-randomized, single arm, open label study in subjects requiring a heart transplant. study donor hearts meeting extended criteria are preserved via non-ischemic heart preservation (nihp) using the xvivo heart preservation system (xhps).

Eligibility criteria:
recipient inclusion criteria: 1. age ≥18 years. 2. signed informed consent form (icf). 3. listed for heart transplantation recipient exclusion criteria: 1. previous solid organ or bone marrow transplantation. 2. requires a multi-organ transplant. 3. subject is enrolled and ongoing in another investigational pharmaceutical or medical device clinical trial (exception: observational studies are permitted). 4. subject is on mechanical circulatory support pre-transplant other than durable lvad, impella or intra-aortic balloon pump. 5. history of complex congenital heart disease ie: single ventricle physiology (per investigators discretion). 6. subject on renal replacement therapy/dialysis. 7. ventilator dependence (subject is intubated at time of transplant/unable to provide consent or re-affirmation of consent). 8. sensitized subject is undergoing desensitization treatment. donor inclusion criteria: 1. estimated cross clamp time ≥ 4 hours, or 2. estimated cross clamp time ≥ 2 hours, and any one or more of the following: * age ≥ 50 years * lvef 40-50% at time of provisional acceptance * down-time ≥ 20 mins * hypertrophy/septal thickness \>12- ≤16mm * angiographic luminal irregularities with no significant cad, or 3. donation after circulatory death (dcd) donors. donor exclusion criteria: 1. unstable hemodynamics requiring high-dose inotropic support. 2. significantly abnormal coronary angiogram defined as cad \> 50% stenosis of one or more vessels. 3. moderate to severe cardiac valve pathology. 4. investigator's clinical decision to exclude from trial. 5. previous sternotomy.
clinical trial to explore papilocare gel efficacy to repair of the cervico-vaginal mucosa with hpv high risk lesions.

Conditions: Human Papilloma Virus; Human Papilloma Virus Infection; Cervix Lesion

Summary: phase ii, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel papilocare in the repair of the cervico-vaginal mucosa with lesions caused by hpv-hr. all the patients included in the study will be randomized (1:1:1:1) in 4 arms.

phase ii, exploratory, randomized, open, controlled and parallel groups clinical trial to evaluate the effectiveness of exploratory gel papilocare in the repair of the cervico-vaginal mucosa with lesions caused by hpv-hr. all the patients included in the study will be randomized (1:1:1:1) to arm a (papilocare schedule a), arm b (papilocare schedule b) and arm c (papilocare schedule c) arm d (usual clinical practice-without treatment-). selection period of 1 month, followed by randomization and 6 months of treatment followed by a period of another 6 months without treatment. patients will visit the site into a total of 5 visits throughout the study. total study duration: 13 months.

Eligibility criteria:
inclusion criteria: 1. woman between the ages of 30 and 65 (both inclusive). 2. able to read and understand the patient information sheet and the informed consent form. 3. acceptance in the participation of the essay and signature of the informed consent form. 4. asc-us or lsil or ag-us cytological result (maximum 3 months prior to inclusion) with concordant colposcopic image (performed at the screening visit). 5. high risk hpv positive by pcr performed at screening visit. 6. is able, at the discretion of the researcher, to comply with the requirements of the trial and without hindrance to follow the instructions and assessments throughout it. exclusion criteria: 1. clinically relevant immune system alterations, or any other autoimmune disease or in treatment with immunosuppressants. 2. non-diagnosed abnormal genital hemorrhage (during the 6 months prior to the screening visit). 3. to had been vaccinated against hpv. 4. other symptomatic vulvovaginal infections. 5. surgical cervical excision in the last year or total hysterectomy. 6. previous history of gynecological cancer. 7. participation in any other clinical trial at present or in the 4 weeks prior to the inclusion of the trial. 8. any planned surgery that prevents the correct compliance with the guidelines. 9. use of vaginal contraceptives or other vaginal hormonal treatments. 10. contraindications for the use of papilocare® gel or known allergies to any of its components. 11. women of childbearing age who do not use effective contraceptive methods, pregnant women, with suspicion of pregnancy or woman who are breastfeeding.

Keywords: hpv
impact of phonatory and facial morphology disorders, on the quality of life of adolescents with pierre robin sequence

Conditions: Pierre Robin Syndrome

Summary: the study team has made the hypothesis that the intensity of the phonatory disorders (rhinolalia), and of the maxillo-mandibular growth anomalies (facial morphology), may have negative effects on the quality of life of adolescents with pierre robin sequence. the investigators also want to assess the impact of 2 different surgical protocols of closure of the cleft palate (1 or 2 step(s)), on the current phonatory and morphology aspects. these 2 protocols were performed, by 2 parisian clinical teams, that have now been merged at necker hospital.

in this protocol, the investigator will include patients who were treated, via maxillo-facial surgery, in their early childhood for a pierre robin sequence. in the frame of a follow-up visit, if they accept to participate in the study, they will fulfill with 2 psychologists, 3 quality of life questionnaires, and 1 depression assessment questionnaire. this will aim at evaluate their quality of life and their social integration, at the time of adolescence.

Eligibility criteria:
inclusion criteria: * having a pierre robin sequence, either isolated, either integrated to a collagenopathy, or associated to any other malformation, but without any mental retardation * being schooled in normal environment, with a maximum of 2 years of academic delay * having being treated, in the early childhood, for a maxillo-facial surgery, either in paris-necker or paris-trousseau hospitals (1 or 2 step(s) protocols) exclusion criteria: * having any other form of pierre robin sequence (syndromic or associated to a mental retardation) * having more than 2 years of academic delay, or being schooled in a specialized environment * having an organic severe intercurrent disease, that could have an impact on the quality of life of the patients.
pharmacokinetic guided dose escalation and dose confirmation with oral decitabine and oral cytidine deaminase inhibitor (cdai) in patients with myelodysplastic syndromes (mds)

Conditions: Myelodysplastic Syndrome; MDS

Summary: this first-in-human, 3-stage, open-label study evaluated the safety and pharmacokinetics of astx727, as well as determined the dose for later stages.

the trial was designed to define daily doses of the individual components (cedazuridine \[e7727\] or decitabine) so that decitabine exposure after oral administration would be comparable to exposure after iv decitabine at the approved daily dose of 20 mg/m\^2. the main objective of phases 1 and 2 was to establish and confirm the doses of the 2 components to be used in the final fixed-dose combination (fdc) product (astx727) using mainly pharmacokinetics and pharmacodynamics as endpoints.

Eligibility criteria:
inclusion criteria: * international prognostic scoring system (ipss) low, intermediate -1, intermediate-2, or high risk mds (including chronic myelomonocytic leukemia; cmml) in dose escalation and dose confirmation-randomization; only intermediate-2, or high risk mds in dose confirmation-open label * eastern cooperative oncology group (ecog) 0 to 2 * no major surgery within 2 weeks of starting study treatment * no cytotoxic chemotherapy within 2 weeks of starting study treatment * able to swallow pills exclusion criteria: * previous treatment with 2 or more courses of decitabine (all stages) or azacitidine (dose confirmation stage only) * treatment with investigational therapy within 2 weeks of study treatment * uncontrolled medical disease(s) or active, uncontrolled infection * diagnosed with acute myeloid leukemia (aml) * active uncontrolled gastric or duodenal ulcer * known history of hiv or hepatitis c or b

Keywords: myelodysplastic syndrome mds