Kornimate/medical-research-clean huggingface dataset:
drug coated ballon in critical limb ischemia

Conditions: Drug Coated Balloon

Summary: evaluate the safety and efficacy of drug coated balloon (dcb) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (cli)

critical limb ischemia (cli) is the most advanced stage of peripheral artery disease (pad); which is estimated to affect more than 200 million people worldwide.(1) cli classified as rutherford category (rc) 4-6, includes ischemic rest pain and tissue loss.(2) the first line revascularization strategy for patients with cli is endovascular percutaneous transluminal angioplasty (pta).(3) the treatment of femoropopliteal lesions displays a huge anatomic challenge as this segment serves various biomechanical functions, which makes endovascular treatment is challenging.(4) plain balloon (pb) angioplasty for femoropopliteal artery disease has a high rate of procedural success and an acceptable safety profile, in spite of initially encouraging technical success after femoropopliteal (pta), postprocedural restenosis remains the major challenge(5) excessive extracellular matrix material synthesized by activated smooth muscle cells (smc) in the media of the arteries leads to neointimal hyperplasia and restenosis.(6) restenosis resulting in loss of primary patency, late lumen loss (lll), occlusion and/or the need for target lesion revascularization (tlr).(7) drug-coated balloons (dcbs) inhibit the neointimal hyperplasia, the biological mechanism of restenosis formation, by application of cytostatic agents in a local therapeutic concentration.(8) the antiproliferative paclitaxel (ptx) seems to be the most effective therapeutic agent for dcbs due to local retention in the arterial wall.(9)

Eligibility criteria:
inclusion criteria: * adults at least 18 years of age with critical lower limb ischemia (rutherford category 4, 5), stenotic (≥70% by visual angiographic assessment) or occlusive lesions in the native sfa or ppa, and vessel diameter ≥4 and ≤6 mm were eligible. * total lesion length ≤190 mm (visual angiographic assessment). * de novo angioplasty * recurrent or recoil lesion exclusion criteria: * pregnancy * breast feeding * iliac lesions * malignancy * patients with raised renal chemistry. * patients with contraindication to antiplatelet therapy.
phase 1 oral solution and crushed tablet relative bioavailability study of apixaban when administered through a nasogastric tube in healthy subjects

Conditions: Healthy Subjects

Summary: the purpose of this study is to assess the bioavailability of apixaban oral solution administered through an nasogastric tube (ngt) in the presence of boost® plus and apixaban administered as crushed tablet through a nasogastric tube relative to apixaban solution administered orally in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations exclusion criteria: * any significant acute or chronic medical illness * any history or evidence of abnormal bleeding or coagulation disorders, intracranial hemorrhage, or abnormal bleeding (including heavy menstrual bleeding that has resulted in anemia within the past 1 year) or coagulation disorders in a first degree relative
a real-world study of nitric oxide generator and delivery system

Conditions: Pulmonary Hypertension of Newborn

Summary: the study is aimed to observe the efficacy and safety of nitric oxide generator and delivery system in pulmonary hypertension of newborn in real clinical settings.


Eligibility criteria:
inclusion criteria: 1. clinically considered to benefit from inhaled nitric oxide (ino) and decided to use nitric oxide generator and delivery system by clinicians 2. admitted to the department of neonatology at the hospital, gender unlimited 3. diagnosed as pulmonary hypertension and undergoing/decided to undergo respiratory support 4. documented oxygenation index (oi) ≥8 prior to the treatment 5. signed informed consent by the parent(s) or the legal representative(s) with fully aware of the benefits and risks of this study exclusion criteria: 1. proven risks of nitric oxide contraindication 2. undergoing or expected to need a combination of other pulmonary vasodilators, surfactants or extracorporeal membrane oxygenation 3. other circumstances that investigators believe unsuitable for enrollment
safety and efficacy of veronate® versus placebo in preventing nosocomial staphylococcal sepsis in premature infants

Conditions: Nosocomial Infections; Sepsis; Staphylococcal Infections; Candidemia

Summary: the purpose of this study is to show whether veronate, a donor-selected staphylococcal human immune globulin intravenous (igiv), can prevent an infection in the blood caused by staphylococcal bacteria in premature babies weighing between 500 and 1250 grams at birth. babies are enrolled between day of life 3 and 5. babies are randomized to either veronate or placebo (50-50 chance of either). babies can receive up to 4 doses of the study drug on study days 1, 3, 8 and 15 and are followed until study day 70 or discharge from the hospital.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from parent or legal guardian * birth weight 500 to 1250 g, inclusive * age 3 - 5 days (49 to 120 hours), inclusive * expected to require iv access for medical care through day of life 14 exclusion criteria: * already received or likely to receive prior to first infusion of study drug: * igiv or \*immune globulin for prevention of hepatitis b * receiving an agent for prevention of staphylococcal catheter related or nosocomial infections (e.g., vancomycin) * active sepsis, as defined by one of the following: * culture proven early onset sepsis and not clinically stable; or * clinical signs of sepsis and pending blood cultures; if the blood cultures are negative after 48 hours and the infant is clinically stable, the infant may be randomized * severe congenital anomaly, where the prospects for survival, the medical complications and treatment, would compromise the study related outcome evaluation(s) in the investigator's opinion * diagnosis of congenital immunodeficiency * evidence of significant fluid overload or significant volume depletion * evidence of abnormal renal function as measured by serum creatinine \> 1.6 mg/dl

Keywords: late onset sepsis premature infants staphylococcus candida prevention
cognitive-behavioral treatment of gambling

Conditions: Gambling; Mental Health

Summary: this study will determine the effectiveness of cognitive behavior therapy (cbt) and contingency management (cm) in reducing gambling behaviors and other related problems in pathological gambling. study hypothesis: participants who receive cbt and cm will attend more treatment sessions and show better outcomes than those who receive cbt alone.

pathological gambling has become an increasingly problematic condition in the united states, often causing serious financial, psychological, and public health consequences. in an effort to treat this growing problem, researchers have evaluated numerous therapies; one such therapy is cbt. cbt has been shown to improve pathological gambling outcomes. however, evidence suggests that adding cm to cbt could result in even more improved outcomes. this study will compare the effectiveness of cbt and cm with that of cbt alone in reducing pathological gambling. this study will last 12 months. participants will be randomly assigned to receive either cbt and cm or cbt alone for 8 weeks. cbt will focus on reducing gambling urges and helping patients develop alternative behaviors to gambling. cm will focus on encouraging patients to avoid gambling. participants in the cbt and cm group will receive voucher incentives for completing homework assignments and engaging in non-gambling social activities. the vouchers will allow participants to take part in non-gambling activities of their choice. changes in gambling activities and problems will be assessed with self-report scales and interviews at study start and at weeks 10, 24, and 52. participants will be asked to identify at least one person who knows about their gambling and will have regular contact with them over the 12 months of the study. this person will be interviewed at study start and at months 2, 6, and 12. contact persons will be asked about participants' gambling behaviors, personal relationships, legal problems, use of health care and mental health services, and how the participant can be contacted if he or she moves. for information on related studies, please follow these links: http://clinicaltrials.gov/show/nct00158314 http://clinicaltrials.gov/show/nct00618462

Eligibility criteria:
inclusion criteria: * diagnosis of pathological gambling * at least 1 gambling episode within 30 days prior to study entry * able to read english at a 5th grade level * willing and able to comply with all study requirements exclusion criteria: * uncontrolled psychiatric conditions

Keywords: pathological gambling cbt cm
tele-coaching community-based exercise (cbe) study

Conditions: Hiv

Summary: the primary aim of this research is to evaluate the implementation of an online tele-coaching community-based exercise (cbe) intervention with adults living with hiv.

investigators will use the re-aim (reach-effectiveness-adoption-implementation-maintenance) framework to evaluate the tele-coaching cbe intervention. the re-aim framework includes criteria to evaluate the impact and translation of an intervention at both individual and organizational levels in order to promote uptake, transferability and ultimate enhance the impact of health promotion interventions. specific study objectives are: 1) to determine the extent (proportion of sessions attended, frequency, intensity, time, type) to which adults living with hiv participate in the intervention (reach); 2) to assess the impact of the intervention on physical activity, health, and engagement in the care cascade (effectiveness); 3) to assess engagement in exercise for adults living with hiv over time (physical activity, adherence) (maintenance); and 4) to evaluate the a) process (strengths, challenges, accessibility, cost, fidelity) and b) feasibility of sustainability of the implementation, from the perspective of adults living with hiv, representatives of community-based organizations (cbos), health and fitness centres, health providers, and policy stakeholders to build capacity, products, and considerations for broader implementation (implementation and adoption). investigators will conduct a prospective longitudinal mixed methods intervention study to evaluate the implementation of an innovative online tele-coaching cbe intervention with adults living with hiv. they will use a combination of quantitative (self-reported questionnaires, fitness assessments) to assess outcomes bimonthly during the tele-coaching cbe intervention (6 months) and during a follow-up monitoring phase (6 months) to evaluate the short and long term impact of online cbe. investigators will use a qualitative longitudinal design using interviews to assess processes and outcomes at baseline (0 months), post-intervention (6 months) and post-follow-up (12 months).

Eligibility criteria:
inclusion criteria: * adults (18 years and older) living with hiv who consider themselves medically stable and safe to engage in exercise. * access to technology (computer/tablet, wi-fi, web-cam). * willing to take part in a 12 month study involving thrice weekly exercise. exclusion criteria: • not applicable.

Keywords: hiv exercise community-based exercise tele-rehabilitation tele-health rehabilitation disability tele-coaching
impact of the betaconnect auto-injector on betaseron therapy adherence and patient satisfaction

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the primary objective of this study is to assess adherence and persistence to betaseron therapy in patients who are using the betaconnect auto-injector device (betaconnect device). the secondary objective of this study is to assess patient-reported satisfaction with the betaconnect device.


Eligibility criteria:
inclusion criteria: * male and females greater than or equal to 18 years of age * diagnosis of rrms according to revised mcdonald criteria (2010) or (cis) * prescribed betaseron (note: decision to treat with betaseron must be made independent of participation in this study) * confirmation of insurance coverage for betaseron treatment * access to a personal computer to complete online patient satisfaction survey at week 6 exclusion criteria: * currently enrolled in a clinical trial or other observational study for multiple sclerosis treatment * documented substance abuse within the previous 6 months prior to study enrollment * any major laboratory value abnormality that the investigator believes would preclude the patient from participating in the study * any medical disorder, condition or history that in the opinion of the investigator would impair the patient's ability to participate in or complete the study * pregnant or nursing

Keywords: adherence persistence patient satisfaction
single cell sequencing analysis of thymoma

Conditions: Thymoma

Summary: the purpose of this study is to understand how genetics play a role in thymoma. intratumoral heterogeneity is among the greatest challenges in precision cancer therapy. however, developments in high-throughput single-cell rna sequencing (scrna-seq) may now provide the statistical power to dissect the diverse cellular populations of tumors. this study aims to find out how it affects genetic and protein expression in patients with malignant thymoma, compared to benign thymoma, at a single-cell level using a flow cytometry and rna-sequencing protocol.


Eligibility criteria:
inclusion criteria: * patients diagnosed with thymoma * ability to provide written consent and comply with the protocol * at least 18 years of age exclusion criteria: * patients undergoing thymoma treatment * patients with previous malignancy * known hiv positive status. * evidence of abnormality of any immune cell population from a drug-induced or genetic cause.
controlling myopia progression with soft contact lenses (contact lens control)

Conditions: Myopia

Summary: this study is to investigate whether novel soft contact lens optical designs can slow myopia progression


Eligibility criteria:
inclusion criteria: 1. the subject must be between 8 and 12 years of age. 2. at least one of the subject's parents or legal guardian must read and understand english or chinese. 3. the subject's manifest objective refraction (measured with an auto refractor) must be sphere: between -0.25d and -4.50d, and cylinder: \<1.50d in each eye. 4. the subject's best sphere contact lens correction must lie between -0.75d (better of the two eyes)and -4.25d (poorer of the two eyes). 5. the subject's cycloplegic objective refraction must be here: between -0.75d and -4.00d cylinder: \< or equal to 1.00d in each eye. 6. the subject must have 1.00d or less difference in spherical equivalent between the two eyes with cycloplegic refraction. 7. the subject must have a spectacle lens best-corrected visual acuity of 0.8 (20/25) or better in both eyes. 8. the subject's parent or legal guardian must read and sign the staement of informed consent and the subject must read and sign the child's assent form and be provided a copy of each form. 9. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. exclusion criteria: 1. ocular or systemic allergies or diseases that may interfere with contact lens wear. 2. systemic disease or autoimmune disease or use of medications (e.g. antihistamine), which may interfere with contact lens wear. 3. clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear. 4. clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear. 5. any ocular infection. 6. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. any infectious disease (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. hiv) 8. diabetes 9. anisometropia of greater than 1.00d by cycloplegic refraction. 10. astigmatism of greater than 1.00d in either eye by cycloplegic refraction. 11. eye injury or surgery within eight weeks immediately prior to enrollment for this study. 12. previous refractive surgery, orthokeratology, keratoconus, or other corneal irregularity in either eye. rigid contact lens wearers cannot be enrolled in the study unless they are off rigid contact lenses for at least 4 weeks. 13. strabismus in either eye. 14. pupil or lid abnormality or infection in either eye 15. central corneal scar in either eye 16. aphakia in either eye 17. contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear. 18. history of participation in prior clinical trials aimed to control myopia progression. 19. surgically altered eyes, ocular infection of any type, ocular inflammation. 20. an anterior chamber angle grade 2 or narrower by the van herrick method
sensorimotor dysfunction in achalasia

Conditions: Achalasia

Summary: this study is being done to assess the esophageal muscle (swallowing tube) in patients with and without achalasia to further understand and help direct the treatment for patients with achalasia.

achalasia is currently defined solely on the basis of esophageal manometry. however, this fails to assess sensory function which may relate more to symptoms such as chest pain and heartburn. to date, the importance of sensory dysfunction in achalasia is poorly understood. the investigators want to define the relationship between esophageal sensory and motor dysfunction and symptoms in achalasia. following standard diagnostic evaluation including esophagogastroduodenoscopy (egd), barium esophagram, and esophageal manometry, symptoms will be assessed utilizing a standardized questionnaire. the subjects will then undergo transoral placement of an esophageal barostat. following a standard protocol of esophageal distension, esophageal body compliance will be recorded with esophageal body pressure and volume. mechanosensitivity will then be assessed utilizing a stepwise esophageal distension, with patients reporting symptoms utilizing a likert scale. patients will then undergo conventional achalasia treatment with either pneumatic dilation or heller myotomy at the discretion of the treating gastroenterologist. thereafter patients will be followed via a standardized phone survey at 3 months, 6 months, 2 years, and 4 years after treatment to assess symptoms and treatment response. patients will have standard clinical follow ups, including barium esophagram, at 1 year, 3 years, and 5 years following treatment. outcomes: from 100 new patients with achalasia seen yearly at mayo, the investigators anticipate recruitment of 40 eligible patients over 12 months and 10 healthy volunteers. the correlation between mechanosensitivity and esophageal body compliance with symptoms such as dysphagia, chest pain, and heartburn will be measured in types i, ii and iii achalasia. the association of these parameters with conventional manometrically defined achalasia subtypes will also be measured. finally, the relationship between sensorimotor dysfunction in achalasia and therapeutic outcomes will be assessed with development of predictive models to assess symptomatic outcome by barostat measurements.

Eligibility criteria:
inclusion criteria: * adults ages 18-90 * patients with achalasia, defined by an esophageal manometry study consistent with the diagnosis exclusion criteria: * patients with egd or esophagram findings suggestive of pseudoachalasia * previous history of pneumatic dilation, heller myotomy, or botulinum toxin injection to the distal esophagus * esophageal diameter greater than 6 cm * previous history of upper gastrointestinal surgery * medical conditions such as severe heart or lung disease that preclude safe performance barostat * inability to read due to: blindness, cognitive dysfunction, or english language illiteracy

Keywords: trouble swallowing food sticking achalasia
developing and testing of culturally adapted cognitive behavior therapy (cacbt) for pashto speaking pakistanis and afghans

Conditions: Depression, Anxiety

Summary: cbt for common mental disorders has a strong evidence base in both the usa and the uk. there are wider cultural and linguistic differences between non pashtun and pashtun population of pakistan and afghanistan and there is evidence from research to suggest that cbt might need some adaptations when working with clients from non-western background. this study, thus, aims to culturally adapt cbt for common mental disorders for pashto speaking population in pakistan and afghanistan and to test the effectiveness of this adapted cbt through a small scale pilot study. the study will be carried out using mixed methods; quantitative and qualitative. qualitative part will consist of structured interview with a minimum of 10-15 patients; carers; and mental health professionals, respectively, using the interview questionnaires. the data will be analysed by systematic content and question analysis which will identify the emerging themes and categories. the data will then be reorganized into wider themes and categories and written for guidelines to culturally adapt therapy manual for common mental disorders. quantitative phase will be a rct involving 40 patients (20 in each arm) to assess the effectiveness of a "cacbt intervention" for pashto speaking patients. all those who fulfill the diagnostic criteria of depressive episode or recurrent depressive disorder using icd 10 rdc, are living near or can easily travel to the psychiatry departments in peshawar, will be included in the study. the intervention group of the rct will receive cacbt intervention in addition to the treatment as usual (tau) while the control group receives tau. the assessment will be carried out at base-line and at the end of therapy (8-12 weeks). bradford somatic inventory (bsi), hospital anxiety and depression scale (hads) and brief disability questionnaire (bdq)/ who das will be used to measure somatic symptoms, anxiety, depression and disability due to physical and psychological problems, respectively. schwartz outcome scale will be used at follow up to measure the outcome.


Eligibility criteria:
inclusion criteria: * all those who fulfill the diagnostic criteria of depressive episode (f32) or recurrent depressive disorder (f33 except 33.4) or anxiety disorder using icd10 rdc and who live within travelling distance of the psychiatry department in peshawar will be approached. those patients, who have agreed to enter the study, will be assessed 2 weeks later, to fill in the baseline measures when they attend their first appointment. patients will be asked to attend a further appointment at the end of study period and will be assessed again. exclusion criteria: * excessive use of alcohol or drugs (using icd 10 rdc for alcohol or drug abuse or dependence) significant cognitive impairment (for example learning disability or dementia) and active psychosis.

Keywords: cognitive behavior therapy depression anxiety pashto pakistani afghan