Kornimate/medical-research-clean huggingface dataset:
comparison between anterior and direct lateral approach in total hip arthroplasty

Conditions: Coxarthrosis

Summary: in total hip arthroplasty several approaches can be used. the newly introduced minimally invasive anterior approach is supposed to cause less damage to tendons and muscles. at the same time there are reports that there are more complications when this approach is used. the direct lateral approach is the most used in norway and is well documented. there are however those who postulate that there is to high risk of damage to the gluteus medius causing trendelenburg gait. in the investigators hospital both the anterior and direct lateral approach is used with good result. the investigators main study hypothesis is that there is no difference between the use of anterior or direct lateral approach i total hip arthroplasty in regards to postoperative function and pain, complications, radiological finds (x-ray and mri), markers for muscle damage (i.e ck-total) or other clinical outcomes.


Eligibility criteria:
inclusion criteria: * clinical and radiological diagnosis of coxarthrosis exclusion criteria: * previous surgery on affected hip * no mental disability preventing follow-up

Keywords: coxarthrosis hip arthroplasty anterior approach direct lateral approach hardinge approach smith-petersen approach osteoarthrosis
a study of shr-a1912 for injection in patients with b cell lymphomas

Conditions: B Cell Lymphoma

Summary: to assess the safety and tolerability of shr-a1912 in patients with b cell lymphoma, to determine the dose-limiting toxicity (dlt), maximum tolerated dose (mtd), and recommended phase ii dose (rp2d) of shr-a1912.


Eligibility criteria:
inclusion criteria: 1. age greater than or equal to18 years old, male or female; 2. eastern cooperative oncology group (ecog) performance status is 0 to 1; 3. life expectancy \>12 weeks; 4. histologically or cytologically confirmed b cell lymphoma; 5. relapsed and/or refractory disease after at least 1 prior treatment regimen; 6. at least one measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one measurable extra nodal lesion, defined as \> 1.0 cm in its longest diameter (no need for dose escalation stage). exclusion criteria: 1. received autologous stem cell transplantation within 12 weeks before the first study treatment; previously received allogeneic stem cell transplantation; received car-t cell therapy within 12 weeks before the first study treatment; 2. history of recent major surgery or severe trauma within 4 weeks before the first study treatment; 3. received anti-tumour treatment within 2 weeks before the first study treatment; 4. central nervous system (cns) infiltration; 5. active infection with hbv or hcv; 6. history of immunodeficiency, including hiv serotest positive, or other acquired or congenital immunodeficiency diseases, and active tuberculosis; 7. active infection or unexplained fever\>38.5℃; 8. history of severe cardiovascular disease.
effects of mindfulness training on emotion regulation and social cognition.

Conditions: Stress, Psychological; Emotional Stress; Social Cognition; Mindfulness

Summary: the present study will investigate the effects of a mindfulness training on emotion regulation and social cognition, using several psychological, behavioral, psychophysiological and neuroimaging methods.

the aim of the present study is to evaluate the impact of a mindfulness intervention, particularly the mindfulness-based stress reduction (mbsr), on the capacities of emotion regulation and social cognition, in caring/helping professions which are vulnerable to stress. in the context of a longitudinal intervention study, a randomized controlled trial, the efficacy of the mbsr to increase the capacity for self-emotion regulation, empathic attunement, and compassion capacities will be measured. for doing this, several psychological, behavioral, psychophysiological and neuroimaging brain measurements will be used.

Eligibility criteria:
inclusion criteria: * healthy volunteers: men or women * right-handed * normal or corrected-to-normal visión * german as a first language * no history of neurological or psychiatric problems, or use of controlled medication that might interfere with emotion or attention. * no symptoms of claustrophobia * written informed consent form to participate in the study and neuro-imaging experiment. exclusion criteria: * chemical dependence, including nicotine and alcohol * dementia or psychotic condition. * depression or use of antidepressants * pregnant or breast-feeding women * prior mbsr class or regularly practicing mindfulness meditation (or yoga) for three or more months. * non-controlled severe medical disease that might interfere with the performance of the study, such as neoplasias, cardiopathies, digestive pathologies, diabetes mellitus type i or type ii * neoplasias in the central nervous system * tremor or dystonia in cephalic segment that hinders the performance of the mri study (tremor equal to or higher than 3 in each corporal segment, according to the updrs scale) * fulfillment of any criterion of contraindication for the mri exam (for instance, metallic implants, claustrophobia, pregnancy, use of pacemaker; intracranial aneurism clip; cochlear implants). * presence of odontological devices that might disturb the magnetic field or any sources of variation of the magnetic susceptibility * any other conditions the investigator might deem problematic for the inclusion of the volunteer in a trial of this nature will also be considered.
clinical efficacies of different agents in molar-incisor hypomineralization

Conditions: Molar-Incisor Hypomineralization

Summary: this study aims to assess the clinical effectiveness of gc fuji triage ® (gc america inc., alsip, illinois) and beutisealant (shofu, kyoto, japan) in children aged 8-13 with multiple molars affected by molar-incisor hypomineralization (mih). the comparison focuses on permanent first molars affected by mih.

the study targets children within the specified age range with mih-affected molars, comparing the clinical outcomes of gc fuji triage and beutisealant. the assessment will provide valuable insights into the efficacy of these agents in managing severe hypomineralization, contributing to our understanding of effective treatment modalities for mih. the evaluation criteria include restoration success, prevention of further decay development, prevention of post-eruption breakdown, alleviation of tooth sensitivity, and measurement of life quality. these criteria will be compared with those of resin fissure sealant.

Eligibility criteria:
inclusion criteria: * healthy children aged 8-13 with hypomineralization in their first permanent molars. * children without systemic diseases or developmental dental anomalies that could affect hypomineralization. * those with at least two molars exhibiting molar-incisor hypomineralization (mih), specifically scoring 1 and 3 according to the mih-tll index. * children with a positive or 'definitely positive' cooperation according to the frankl behavior rating scale (frankl et al., 1962). * absence of spontaneous pain, abscess, mobility, or inter-radicular lesions in the tooth to be treated. * patients or their parents consenting to participate in the treatment. exclusion criteria: * children with systemic diseases or developmental dental anomalies that could affect hypomineralization. * to have mih outside the specified scores. * children unable to continue treatment in the chair due to cooperation problems. * failure to attend control sessions or a desire not to continue with the study. * patients and their parents unwilling to participate in the treatment. * if the patient cannot attend control sessions or disrupts sessions, they will be withdrawn from the study.
tadalafil and acetazolamide versus acetazolamide in acute mountain sickness prevention

Conditions: Pulmonary Edema; Cerebral Edema

Summary: to evaluate the additive value of tadalafil given together with diamox (acetazolamide) in preventing acute mountain sickness in travelers to high altitude areas.

a randomized controlled study comparing: tadalafil \[20mg x1/day\] and acetazolamide \[125mg x2 day\], versus acetazolamide \[125mg x2 day\] alone, in trekkers to altitude \> 3,000 m.

Eligibility criteria:
inclusion criteria: * participant in trekking to high altitude * agreement to sign the informed consent. exclusion criteria: * no agreement to sign informed consent.

Keywords: acute mountain sickness travellers acetazolamide tadalafil acute mountain sickness assessed by lake louise score high altitude pulmonary edema high altitude cerebral edema
orthokeratology for keratoconus

Conditions: Orthokeratology; Keratoconus

Summary: to investigate a possible benefit of orthokeratology contact lenses to improve uncorrected visual acuity of keratoconus patients


Eligibility criteria:
inclusion criteria: * moderate keratoconus * no apical scars exclusion criteria: * advanced keratoconus * apical scaring * contact lens intolerance

Keywords: orthokeratology keratoconus
faecal bacteriotherapy for postantibiotic diarrhoea in critically ill patients

Conditions: Diarrhea Caused by Drug; Clostridium Difficile Infections

Summary: rationale: postantibiotic diarrhoea in critically ill patients is common, often prolonged and currently there is no effective treatment of it. aim: to test safety and feasibility of faecal microbial transplantation in critically ill patients with postantibiotic diarhoea. design: prospective, single center, parallel group randomised controlled trial. subjects: icu patients (both general and burn icu) who developed diarhea after a course of antibiotic therapy that is persistent for 24 hours and is not due to other causes. patients with septic shock or approaching death will be excluded. treatment in the intervention group: faecal bacteriotherapy (fbt) delivered as enema (and repeated once in the subgroup of patients with c. dif. infection) of 350 ml of standardised mixed transplantate prepared from faeces of 7 healthy donors. control group: standard-of-care protocolised treatment of postantibiotic diarhea (which includes vancomycine 250 mg p.o. 6 hourly in the subgroup with c. dif. infection). primary outcome: percentage of patients with treatment failure at day 7 after randomisation, which is defined as treatment either not being delivered or not being effective. secondary and exploratory outcomes: influence of the intervention on colonic microbiome and metabolome, small bowel and colonic permeability, bacterial translocation and systemic inflammation response to procedure.


Eligibility criteria:
inclusion criteria: * signing of informed consent (see below) * age \> 18 yrs. * in-patient in icu or hdu (incl. burn unit) and expected to stay for \>7 days * diarrhea following antibiotic treatment defined as 3 or more stools per day or bristol type 7 stool in the volume \>300 ml/day if stool derivative device is in place, persisting for 24 hours despite enteral feeding formula has been stopped. exclusion criteria: * death appears imminent or ceilings of care put in place * presence of new-onset sepsis defined as per 2016 definition * lactate \>2.0 mm, colon diameter \> 9 cm on plain axr * the necessity of ongoing antibiotic treatment for another reasons * unable to tolerate enema for any reason (e.g. surgery of the gi tract in the past year) * pregnant and lactating woman * patients with a history of severe anaphylactic food allergy, any other reason which - as per judgement of the treating clinician - makes faecal transplantation unsafe or not feasible (note: all screening failures based on this criterion will be reported separately, inc. the reason why it was considered unsafe or not feasible to proceed).

Keywords: gut microbiota critically ill fecal microbial transplantation
a safety and effectiveness prospective blinded clinical study to validate xbar system as monitoring tool for anastomotic leaks detection

Conditions: Colorectal Surgery; Anastomotic Leak

Summary: purpose: to validate the safety and effectiveness of xbar monitoring tool for detection of post-operative anastomotic leaks in subjects undergoing rectal/sigmoid resections with anastomosis. the clinical team is blinded to the leak detection of the xbar system.

study design: pivotal, prospective, blinded, multi-center study. study population: this study will enroll approximately 190 eligible subjects undergoing scheduled colorectal surgery with anastomosis, without concomitant diversion. xbar is an investigational device intended for post-op monitoring of patients undergoing gi surgery. the device is comprised of a surgical drain with embedded electrodes, connected to a small electronic device that records and relays data from the electrodes. the collected data is processed for early detection of complications. study description: the study is intended to validate the performance of the xbar system's anastomotic leak detection monitoring tool following colorectal resection with drain placement. during the index surgery the xbar device will be placed according to institution standard procedures and data recording will commence for a period of at least 3 days. safety and complication detection performance will be evaluated retrospectively by comparing the diagnosis on a subject level done by the clinical team, who is blinded to xbar results, and the system.

Eligibility criteria:
inclusion criteria: 1. age ≥ 22 years 2. indication for sigmoid or rectal resection surgery. 3. usage of drain during the surgery (to be confirmed during the surgery) 4. willing and able to comply with the study follow up. 5. able and agree to provide an informed consent. exclusion criteria: 1. contraindication for surgery and/or general anesthesia. 2. pregnancy or lactation. 3. planned or unplanned fecal diversion during the surgery (to be confirmed during the surgery) 4. known electronic device implanted in the chest or the abdominal cavity (e.g., pacemaker, cardioverter/defibrillator). 5. major medical or psychiatric illness or condition, or other factors that may affect general health or ability to adhere to the follow-up schedule. 6. known allergic reactions to materials used in the components of the xbar system, i.e., silicone, rubber and stainless-steel. 7. participation in another interventional study during the xbar system usage.
amrubicin study for elderly patients with extensive-disease small-cell lung cancer (ed-sclc)

Conditions: Small-cell Lung Cancer

Summary: the purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.


Eligibility criteria:
inclusion criteria: * extensive-disease small-cell lung cancer * aged 70 years or older * performance status of 0-2 * no prior chemotherapy exclusion criteria: * prior therapy for primary lesion * pneumonitis and/or pulmonary fibrosis * active concomitant malignancy

Keywords: extensive-disease small-cell lung cancer (ed-sclc)
a real world study of paxlovid for the treatment of hospitalized patients confirmed with covid-19

Conditions: COVID-19

Summary: the study was designed to analyze the efficacy and safety of paxlovid for the treatment of covid-19.

the study is a real-world study and the case records of patients with covid-19 who visit huashan hospital affiliated to fudan university from 2022 to 2027 and receive paxlovid therapy will be collected in this study. the medical data including patient demographic, clinical characteristics, laboratory examination, history of treatments, adverse reactions and treatment outcome will be extracted to analyze the effectivity and safety of paxlovid and explore the prognosis-relevant factors of covid-19.

Eligibility criteria:
inclusion criteria: * participants who have a positive sars-cov-2 test result; * participants who have one or more mild or moderate covid-19 symptoms. exclusion criteria: * no specific exclusion criteria in this real world study.

Keywords: paxlovid
cardiovascular risk in toledo population

Conditions: Cardiovascular Risk Factor; Cardiovascular Diseases

Summary: this epidemiological and observational study is aimed to assess cardiovascular risk (cvr) by investigating the prevalence of cvr factors (cvrf), target organ damage (tod) and cardiovascular disease (cvd) in general population of the sanitary area of toledo.

epidemiological and observational study that is analyzing a sample from the general population aged 18 years or older, randomly selected from a database of sanitary cards stratified by age and gender. clinical history, physical examination and complementary tests are being performed. total blood and serum samples are being frozen (-85ºc) for future genetic studies. the biobank is currently being registered at the "virgen de la salud" hospital of toledo. cvr is assessed by score scale calibrated for spanish population and the framingham heart study scale. patients will be periodically visited, with a minimum follow-up of 5 years. standard statistical analysis will be performed.

Eligibility criteria:
inclusion criteria: * subjects aged 18 years or older, randomly selected from a database of health cards stratified by age and gender exclusion criteria: * individulas aged under 18 years. * subjects who do not sign the informed consent. * subjects that due to different conditions (physical, mental or social) is expected that do not complete the expected follow-up.

Keywords: hypertension diabetes dyslipidemia smoking cardiovascular toledo
robotic top-down intersphincteric resection

Conditions: Colorectal Cancer

Summary: the present study is to develop the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer.

the intersphincteric resection (isr) for the treatment of distal rectal cancer has been a complex two-step surgical procedure consisting of transabdominal mobilization of the anorectum and transanal bowel resection with handsewn coloanal anastomosis. the availability of robotic systems may facilitate the transabdominal approach, simplify the surgical procedures, and achieve better anorectal function for patients with distal rectal cancer requiring an isr. consecutive 40 patients with distal rectal cancer undergoing the single-step robotic transabdominal isr with the intent-to-treat principle will be recruited. the risk factors for a failed transabdominal isr were identified from the prospectively maintained clinicopathologic data using univariate and multivariate analysis. the surgical outcomes, the anorectal function, and the tumor recurrence were compared between patients with a successful or failed robotic transabdominal isr. the investigators believe that the present project can facilitate the development of the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer in our hospital and even in taiwan.

Eligibility criteria:
inclusion criteria: * ct1-3 or yt 1-3 rectal adenocarcinoma whose low border was located below the anorectal sling (4 cm from anal verge), in which the required surgery meets the definition of isr; * clinically tumor-node-metastasis (tnm) stage i-iii rectal adenocarcinoma; * curative and elective surgery; * american society of anesthesiology (asa) class ⅰ to ⅲ patients; * age between 20 and 75 years. exclusion criteria: * ct4 adenocarcinoma, i.e., the rectal cancer invaded to external sphincter or adjacent pelvic organs; * evidence of distant metastasis; * primary tumor mass≧8 cm in diameter; * morbidly obese patients, i.e., body mass index (bmi) ≧ 40 kg/m2 ; * previous major surgery of low upper abdomen; * the adenocarcinoma has invaded to lateral pelvic side wall requiring a lateral pelvic lymph node dissection. (7) patients with poor anorectal function (wexner incontinence score≧ 10)

Keywords: intersphincteric resection (isr) transabdominal isr top-down isr transanal isr rectal cancer
counseling on injectable contraception and hiv risk in tanzania

Conditions: Contraception

Summary: the main objective of the evaluation was to assess the effect of providing injectable and hiv risk counseling messages on contraceptive knowledge and behavior during a three month pilot intervention in ten healthcare facilities in tanzania.

the evaluation assessed the effect of providing injectable and hiv risk counseling messages on contraceptive knowledge and uptake during a three month pilot intervention. the intervention was conducted september-november 2018 in ten healthcare facilities located in the iringa and njombe regions of tanzania. data collection for the evaluation occurred november-december 2018 and included 471 client exit interviews, 26 healthcare provider interviews, and the extraction of monthly aggregate service statistics for 12 months prior to the intervention and three months of the intervention. univariate and bivariate analyses were used to assess quantitative interview data. thematic qualitative assessment was used to assess qualitative interview data from healthcare providers. interrupted time series analysis was used to assess changes in the trend of monthly contraceptive uptake.

Eligibility criteria:
inclusion criteria: * expressed interest in injectable use * hiv-negative or unknown hiv status exclusion criteria: * positive hiv status known to healthcare provider

Keywords: counseling tanzania
study of aoc 1001 in adult myotonic dystrophy type 1 (dm1) patients

Conditions: DM1; Myotonic Dystrophy 1; Myotonic Dystrophy; Myotonic Dystrophy Type 1 (DM1); Dystrophy Myotonic; Myotonic Disorders; Steinert Disease; Myotonic Muscular Dystrophy

Summary: aoc 1001-cs1 is a randomized, double-blind, placebo-controlled, phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple-doses of aoc 1001 administered intravenously to adult myotonic dystrophy type 1 (dm1) patients (marina). part a is a single dose design with 1 cohort (dose level). in part a, the patient duration is 6 months as the treatment period is 1 day followed by a 6 month follow-up period. part b is a multiple-ascending dose design with 2 cohorts (dose levels). in part b, the patient duration is 6 months as the treatment period is 3 months followed by a 3 month follow-up period.


Eligibility criteria:
key inclusion criteria: * genetic diagnosis of dm1 (ctg repeat length ≥ 100) * clinician assessed signs of dm1 * ability to walk independently (orthoses and ankle braces allowed) for at least 10 meters at screening key exclusion criteria: * diabetes that is not adequately controlled * bmi \> 35 kg/m2 * uncontrolled hypertension * congenital dm1 * history of tibialis anterior (ta) biopsy within 3 months of day 1 or planning to undergo ta biopsies during study period * recently treated with an investigational drug * treatment with anti-myotonic medication within 14 days of day 1 note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: dm1 myotonic dystrophy 1 myotonic dystrophy type 1 (dm1) myotonic dystrophy dm dystrophy myotonic myotonic disorders steinert disease marina avidity biosciences avidity aoc 1001 myotonic muscular dystrophy