Kornimate/medical-research-clean huggingface dataset:
als treatment extension study

Conditions: Amyotrophic Lateral Sclerosis

Summary: treatment extension study for als/mnd patients who participated in phase 1 study cmd-2016-001, completed assessments following six 28-day cycles of treatment, and whom the investigator considers would benefit from continued cuatsm treatment.

treatment extension study for als/mnd patients who participated in phase 1 study cmd-2016-001, completed assessments following six 28-day cycles of treatment, and whom the investigator considers would benefit from continued cuatsm treatment. the same safety assessments as in the cmd-2016-001 study will be conducted after each cycle of treatment and the same efficacy assessments as in the cmd-2016-001 study will be conducted after every 3 cycles of treatment. treatment will continue until the first to occur of (1) investigator considers the patient is no longer deriving benefit from cuatsm treatment, (2) patient develops dependence on mechanical ventilation where dependence is defined as being unable to lie flat (supine) without it, unable to sleep without it, or daytime use, or (3) the patient withdraws consent.

Eligibility criteria:
inclusion criteria: * signed informed consent prior to initiation of any study-specific procedures and treatment * documented completion of protocol-specific assessments following completion of six 28-day treatment cycles in study cmd-2016-001 * principal investigator considers the patient would benefit from continued treatment with cu(ii)atsm * not taking riluzole or on the same (or lower) dose used during the cmd-2016-001 study * adequate bone marrow reserve, renal and liver function * women and men with partners of childbearing potential must take effective contraception while on study treatment exclusion criteria: * inability to swallow oral medications or presence of a gastrointestinal disorder (e.g.,malabsorption) deemed to jeopardize intestinal absorption of study drug * dependence on mechanical ventilation (invasive or non-invasive) for any part of day or night, where dependence is defined as being unable to lie flat (supine) without it, unable to sleep without it, or daytime use * dementia that may affect either outcome measures or patient understanding and/or compliance with study requirements and procedures * current use of strong inducers or inhibitors of cyps 2c19 and 2d6
dilapan-s®: a multicenter us e-registry

Conditions: Post Term Pregnancy; Premature Rupture of Membrane; Fetal Growth Retardation; Oligohydramnios; Gestational Diabetes; High Blood Pressure in Pregnancy

Summary: objective of this registry is to collect a representative set of real world data on the use of dilapan-s® for pre-induction cervical ripening in daily clinical practice. upon completion of the registry, relevant collected data will be analyzed and published.

in the us, 23% of pregnant women undergo labor induction. a recent randomized controlled trial showed that elective labor induction at term in low-risk nulliparous women is associated with a lower risk of cesarean delivery and preeclampsia, with no increase in adverse perinatal morbidities. hence, one can assume that labor induction rates will increase. the majority of women undergoing induction have unfavorable cervixes and require cervical ripening agents. dilapan-s®, a hygroscopic cervical dilator made from a patented hydrogel (aquacryl), has been used in the past for cervical ripening for early gestation uterine evacuation. dilapan-s® was approved by the fda for cervical ripening in the third trimester in 2015. the dilapan-s® rods are inserted into the cervical canal, are contained within the vagina, and do not require tension. dilapan-s® works by absorbing fluid from cervical canal cells, resulting in reversible cell membrane dehydration and softening. in addition, the increase in the rod's volume creates a mechanical stretch and leads to the release of endogenous prostaglandins, causing cervical ripening. recently, a multicenter prospective cohort study showed that dilapan-s® is a safe and effective method for cervical ripening in term gestations. lastly, our group performed non-inferiority randomized clinical trial comparing dilapan-s® to foley balloon for cervical ripening in term pregnancies and found that dilapan-s® is non-inferior to foley balloon for pre-induction cervical ripening at term. the dilapan-s® rods are inserted into the cervical canal, are contained within the vagina, and do not require tension. dilapan-s® works by absorbing fluid from cervical canal cells, resulting in reversible cell membrane dehydration and softening. in addition, the increase in the rod's volume creates a mechanical stretch and leads to the release of endogenous prostaglandins, causing cervical ripening. advantages of dilapan-s® over foley include fda approval, safe profile, no protrusion from the introitus, no need to keep under tension and better patient satisfaction.

Eligibility criteria:
inclusion criteria: * pregnant woman whose plan of care is induction of labor * maternal age ≥ 18 years * gestational age ≥ 37 +0/7 weeks * dilapan-s® used for cervical ripening exclusion criteria: * data not available for extraction

Keywords: induction of labour induction of labor labour induction labor induction dilapan dilator cervical ripening cervical priming preinduction pre-induction
happy older latinos are active - cognitive decline

Conditions: Cognitive Decline

Summary: the purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older latino adults living with hiv.

the purpose of this study is to look at the best ways to prevent cognitive decline (loss of memory and/or functioning) in midlife and older latino adults living with hiv. it assesses the feasibility of running a health promotion program, led by a community health worker (chw) intended to help prevent cognitive decline (loss of memory and/or functioning) through a culturally tailored health promotion intervention . eligible participants will be latino/hispanic individuals 50 years of age or older, living with hiv, who may be at risk of developing chronic diseases such as dementia and alzherimer's.

Eligibility criteria:
inclusion criteria: * are latino (self-identified); * are age 50+; * are hiv infected but are virologically suppressed (viral load \<200 copies/ml); * volunteer informed consent exclusion criteria: * have diagnosis of any neurodegenerative disorder or dementia (parkinson's disease, alzheimer's disease, vascular, frontotemporal dementia, etc.) or significant cognitive impairment as indicated by a mini mental status exam score \<24; * have other conditions that could impact cognitive functioning or testing (e.g., legally blind or deaf), currently undergoing radiation or chemotherapy, a history of brain trauma with a loss of consciousness greater than 30 minutes. * have contraindications to physical activity outlined in the american college of sports medicine standards or severe medical illness that precludes them from safely participating in a health promotion intervention. * are unable to complete 10-meter walk test. * have plans to move outside of the miami metropolitan area within the next 6 months or are not living in stable housing (e.g. group home).
vitamin d3 supplementation in participants diagnosed with early-stage prostate cancer who decide to undergo active surveillance treatment regimen.

Conditions: Prostate Cancer

Summary: this clinical trial is aimed at measuring the effect of vitamin d3 supplementation on serum prostate-specific antigen (psa) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (gleason score less than/equal to 6; psa less than/equal to 10; clinical stage t1c or t2a), who elect to have their disease monitored through active surveillance for at least one year.


Eligibility criteria:
inclusion criteria: * lowgrade prostate cancer * serum psa less than/equal to 10 ng/ml * gleason score less than/equal to 6 * referred from their treating physician with treatment plan of active surveillance for one year * serum creatinine less than/equal to 2.0 mg/dl * serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dl * serum calcium greater than 8.5 and less than 10.5 mg/dl exclusion criteria: * concurrent malignancy, except non-melanoma skin cancer * history of sarcoidosis * history of high dose (greater than 1,000 iu daily) vitamin d3 supplementation * history of hypercalcemia * treatment with lithium medication

Keywords: prostate cancer vitamin d3 early stage active surveillance
combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab for macular edema secondary to branch retinal vein occlusion

Conditions: Branch Retinal Vein Occlusion

Summary: this study compares the efficacy of intravitreal bevacizumab monotherapy only or combined therapy of posterior subtenon's triamcinolone acetonide and intravitreal bevacizumab for the treatment of macular edema associated with branch retinal vein occlusion.


Eligibility criteria:
inclusion criteria: 1. the participant must have macular edema associated branch retinal vein occlusion. 2. the participant has retinal photographs, optical coherence tomography (oct) and angiography of sufficient quality, allowing assessment of the macular area according to standard clinical practice. 3. the participant must be willing and able to comply with the protocol. exclusion criteria: 1. the participant has brvo with other ocular vascular diseases such as central retinal vein occlusion, hypertensive retinopathy, etc. 2. the participant has any additional ocular diseases that have irreversibly compromised or could likely compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema, severe non proliferative diabetic retinopathy, or proliferative diabetic retinopathy. 3. the participant has a history of treatment for brvo in the study eye with focal laser photocoagulation, intravitreal triamcinolone acetonide injection or intravitreal bevacizumab injection 4. the participant has a history of intraocular surgery (including lens replacement surgery). 5. the participant has a history of ocular trauma, or current ocular or periocular infection (including any history of ocular herpes zoster or simplex).

Keywords: branch retinal vein occlusion bevacizumab triamcinolone acetonide
long-term results of two surgical methods for scleral iol implantation and fixation in eyes without capsular support: yamane- versus 4-flanged technique

Conditions: Lens Luxation; IOL Subluxation; IOL Opacification; Aphakia - No Lens Capsule

Summary: this study is a comparison of the surgical techniques and postoperative outcome between the two intrascleral iol fixation techniques: yamane technique versus the 4-flanged technique. the main objectives are postoperative lens tilt, duration of surgery, intra- and postoperative complication rates and scleral integrity around the flanges.


Eligibility criteria:
inclusion criteria: * - necessity for iol (re)fixation in the absence of capsular support * willing to give informed consent and follow-up the duration of study exclusion criteria: * anatomical or other contraindications for suture less iol fixation, such as presence of a trabeculectomy bleb or scleromalacia * active inflammatory diseases of the eye

Keywords: scleral fixated iol yamane 4 flanged technique
assess efficacy and safety of the dopamine agonist pramipexole versus levodopa / benserazide (madopar® dr) in patients with restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: the primary objective of this study is to determine that pramipexole (sifrol) 0.25 mg to 0.75 mg daily is not inferior to levodopa 100 mg to 300 mg (in combination with benserazide 25mg to 75mg = madopar dr) daily in the treatment of patients with idiopathic restless legs syndrome fulfilling the international diagnostic criteria. the efficacy parameters include an objective measure of the leg movements during the time spent in bed, and a quantitative clinical assessment of the severity of rls, in the form of the rls-score. in addition, the efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome measures such as quality of life and sleep.


Eligibility criteria:
inclusion criteria: * patients diagnosed with idiopathic restless legs syndrome fulfilling the international diagnostic criteria 1 . * male or female patients, aged 25 to 85 years. * patients presenting rls symptoms almost every day, as judged by the investigator and with more than 5 plm/h during bedtime in each of three screening actigraphy nights. * patients must have given written informed consent in accordance with ich-gcp and local legislation prior to participation in the study. exclusion criteria: * patients with significant diseases other than restless legs syndrome will be excluded. a significant disease is defined as a disease that, which in the opinion of the investigator may put the patient at a risk because of the participation in the study, that may influence the result of the study or the patient's ability to participate or that is expected to relevantly reduce life expectancy. * patients with known hypersensitivity or contraindications to pramipexole, levodopa or benserazide or any other substances present in the study medications. * patients with iron-deficiency * patients with disabilities or other incapacities that preclude regular attendance at clinic for the study visits, and patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle. * patients who have been previously treated with pramipexole or levodopa. * pregnant or nursing women or women of childbearing age who are at risk of pregnancy and are not willing to use adequate contraceptive methods (hormonal contraception or intrauterine devices) during the study period.
surgical treatment of peri-implantitis with and without systemically adjunctive antibiotics

Conditions: Periodontal Diseases; Periimplantitis

Summary: the purpose of this study is to investigate if the use of systemic adjunctive antibiotics in the treatment of periimplantitis is needed.

this study will give the opportunity to draw scientifically based conclusions on the recommendations of the use of adjunctive systemic antibiotics in the treatment of peri-implantitis. this study will also be able to determine the ecological impact on the oropharyngeal and intestinal microflora between different antibiotic treatments. the lack of knowledge in this area has been highlighted by the food and drug administration and the swedish council on health technology assessment (sbu)

Eligibility criteria:
inclusion criteria: 1. male or female ≥18-65 year 2. patients who has been referred by a general dentist to a specialist clinic in periodontology for treatment of peri-implantitis. 3. having sign of peri-implantitis around at least one osseointegrated dental implant that has been in function for ≥ one year 4. peri-implantitis is diagnosed when; ppd of ≥ 6mm can be found at a dental implant in association with bop and/or suppuration together with the loss of marginal alveolar bone of more than 2 mm detected on intraoral radiographs (giving radiographic exposure of at least ≥ 3 fixture threads). 5. partially or completely edentulous subjects with healthy or treated periodontal conditions enrolled in a regular supportive program. 6. full-mouth plaque score (fmps) ≤ 25 7. signed informed consent exclusion criteria: 1. known allergy to amoxicillin, penicillin (pcv), metronidazole or betalactamic 2. contraindication for dental surgical treatment (i.e. immunocompromised, uncontrolled dm (b-ghb-a1c 8-9 %, 64-75 mmol/mol), osteoporosis, i.v bisphosphonate treatment due to malignancy, pregnant and lactating women). 3. incapability to perform basal oral hygiene measures due to physical or mental disorders. 4. received systemic antimicrobial therapy in the past three months. 5. currently on allopurinol, digoxin, disulfiram, lithium, busulfan, 5-fluorouracil, methotrexate, phenytoin, cyclosporine and warfarin. 6. known severe chronic peripheral or central disease of the nervous system 7. known alcohol abuse 8. known hepatic encephalopathy 9. known lactose intolerance, galactose intolerance 10. untreated periodontal condition. 11. implant showing sign of mobility. 12. implants with bone loss exceeding 2/3 of the length of the implant or implants with bone loss beyond any transverse openings in hollow implants. 13. any medical condition or on any concomitant medication that, in the opinion of the investigator, might interfere with the evaluation of the study objectives or jeopardize patient safety patients with xerostomia or having slow bowel motion will be excluded from the group of patients providing salivary and fecal samples.
baduanjin on patients with schizophrenia

Conditions: Schizophrenia

Summary: as an ancient, popular chinese exercise, baduanjin is characterized by symmetrical posture, deep breathing and meditation and easy to learn. previous studies showed immediate effect of baduanjin on cognition in patients with schizophrenia.the purpose of this study is to investigate the immediate effect and chronic effect of baduanjin exercise on physical fitness, cognition and daily functions in middle-aged and older adults with schizophrenia.

a single-blind, 2-arm randomized controlled trial investigating the benefits of baduanjin exercise on middle-aged and older patients with schizophrenia. a total of 48 participants will be assigned to either 12 weeks of 60-minute two sessions per week baduanjin exercise group or a brisk walking group. primary outcomes are physical fitness and cognition functions. secondary outcomes are dual task performance and daily functions. evaluation will be completed at baseline, immediately after treatment and 4-week follow up.

Eligibility criteria:
inclusion criteria: * having a diagnosis of schizophrenia according to the dsm-5. * independent adult aged 40 years or older in the day-care center. * having a stable mental status without shift in medication and keep in same dose for at least one month. exclusion criteria: * serious physical conditions that will impede participation, such as cardiovascular disease, musculoskeletal disease or pulmonary system disease. * visual or auditory impairment that precludes completion of assessment. * acute psychosis requiring hospitalization. * presence of severe withdrawal or profound cognitive disability that cause difficulties in following instructions. * participating in another clinical trial at the same time.

Keywords: schizophrenia, mind body intervention ,baduanjin
acceptance of hepatitis c screening by self-testing in high risk and general population

Conditions: Hepatitis C

Summary: the main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (dbs) testing assisted by center of origin or referral hospital, as a strategy for screening for hepatitis c virus (hcv) in high risk population (ex-users of drug dependence centers) compared to the general population assisted by primary care centers.

this is a randomized clinical trial involving patients who between 2013 and 2017 have contacted the drug dependence center and patients from general population. after selecting those who do not meet any exclusion criteria, a letter will be sent to them inviting them to participate in this study. this letter will contain the study information sheet and informed consent, and a self-testing kit with an explanatory leaflet so that each person can carry out the test in a simple and easy way. the main purpose of the study is to evaluate the acceptance and viability of self-testing using dried blood spot (dbs) testing, to study whether support improves participation and to identify predictors of participation. for the present study, assuming an increase of 18% participation (from 18% to 28% offering support by the patient's referral center, and based on a previous study in our environment of self-testing in the general population), taking into account a power of 80%, alpha error of 5%, and losses of 20%, will require 346 patients per group.

Eligibility criteria:
inclusion criteria: * all subjects who have contacted a drug dependence center between 2013 and 2017, as well as patients from a group of a primary care center. * signed informed consent. exclusion criteria: * patient's refusal to participate in the study. * negative hcv serology or viral load in the last year. * death. * belonging to another health area * not having the patient's address in the hospital's computer system.
effect of electrosurgery on blood loss and intraoperative transfusions in musculoskeletal tumor surgery

Conditions: Blood Loss, Surgical; Transfusion Rate; Electrosurgery; Tumororthopaedics

Summary: resection of malign musculoskeletal tumors and reconstruction with large tumor prostheses often results in relevant blood loss requiring hemodynamic stabilization and transfusion. the use of novel electrosurgical electrodes is assessed retrospectively regarding the potential to reduce blood loss and the need for transfusions.

background resection of malign musculoskeletal tumors and reconstruction with large tumor prostheses often result in relevant blood loss requiring hemodynamic stabilization and transfusion. since machine autotransfusion is contraindicated in tumor surgery, other measures are necessary to reduce intraoperative blood loss. objectives tungsten needle electrodes can be used to simultaneously cut skin and seal bleeding vessels for superficial dissection. spatula electrodes coated with teflon (polytetrafluoroethylene ptfe) are used for coagulation and dissection of deeper tissues. the coating reduces eschar build-up and thus smoke creation compared to conventional stainless-steel electrodes. this study assesses the effect of these novel electrodes on blood loss and transfusion rates. methods: the investigators retrospectively investigate all cases of tumor resection and reconstruction with tumor prostheses that were operated five years before the introduction of the new electrodes (2012-2016) and five years after (2018-2021) by one single surgeon with over 25 years of experience. data are extracted from digital patient records and analyzed by descriptive statistics and t-test for normally distributed data or mann-whitney test in case of non-normal distribution.

Eligibility criteria:
inclusion criteria: * patients who received hemipelvectomy, hip disarticulation, or major tumor prosthesis implantation at our hospital between 2010 and 2021 * operated by one single surgeon exclusion criteria: - implantation of a megaprosthesis without history of tumor