Kornimate/medical-research-clean huggingface dataset:
study to evaluate the efficacy and safety of filgotinib in participants with active psoriatic arthritis who are naive to biologic dmard therapy

Conditions: Psoriatic Arthritis

Summary: the primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the american college of rheumatology 20% improvement (acr20) response in participants with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drug (dmard) therapy. the study consists of two parts, the main study and the long term extension (lte).


Eligibility criteria:
key inclusion criteria: * meet classification criteria for psoriatic arthritis (caspar) and have a history consistent with psoriatic arthritis (psa) ≥ 6 months at screening * have active psa defined as ≥ 3 swollen joints (from a 66 swollen joint count \[sjc\]) and ≥ 3 tender joints (from a 68 tender joint count \[tjc\]) at screening and day 1; these may or may not be the same joints at screening and day 1 * must have a documented history or active signs of at least one of the following at screening: * plaque psoriasis * nail changes attributed to psoriasis * have had inadequate response or intolerance to ≥1 conventional synthetic disease-modifying anti-rheumatic drug (csdmard), apremilast and / or nsaid, administered over the course of ≥ 12 weeks for the treatment of psa, as per local guidelines / standard of care key exclusion criteria: * prior psa or psoriasis treatment with a biologic dmard * prior exposure to a janus kinase (jak) inhibitor \> 2 doses * any active / recent infection * any chronic and / or uncontrolled medical condition that would put the individual at increased risk during study participation or circumstances which may make an individual unlikely or unable to complete or comply with study procedures and requirements, per investigator judgement * any moderately to severely active musculoskeletal or skin disorder other than psa or plaque psoriasis that would interfere with assessment of study parameters, as per judgement of investigator note: prior history of reactive arthritis or axial spondyloarthritis is permitted if there is documentation of change in diagnosis to psa or additional diagnosis of psa * any history of an inflammatory arthropathy with onset before age 16 years old * active autoimmune disease that would interfere with assessment of study parameters or increase risk to the individual by participating in the study (e.g. uveitis, inflammatory bowel disease, uncontrolled thyroiditis, systemic vasculitis, transverse myelitis), per judgement of investigator * pregnancy or nursing females * active drug or alcohol abuse, as per judgement of investigator note: other protocol defined inclusion/exclusion criteria may apply.
ai-based los prediction in hip fracture patients

Conditions: Hip Fractures

Summary: with increasing life expectancy, the elderly population is growing. hip fractures significantly increase morbidity and mortality, particularly within the first year, among elderly patients. managing anesthesia in these elderly patients, who often have multiple comorbidities, is challenging. identifying perioperative factors that can reduce mortality will benefit the perioperative management of these patients. the aim of this study is to develop and validate a machine learning based model to predict the length of hospital stay for hip fracture patients after pacu. different machine learning algorithms such as r language gradient boosting, random forest, artificial neural networks and logistic regression will be used in the study and the best performing model will be determined. in addition, the prediction mechanism of the model will be examined with shap analysis and its applicability in clinical decision processes will be evaluated. thus, by predicting the length of hospital stay, clinicians will be enabled to manage patient care processes more effectively.


Eligibility criteria:
inclusion criteria: * patients who underwent hip fracture surgery at our institution between 2017 and 2024 * patients aged 65 years or older * patients with hip fractures resulting from a low-energy trauma (simple fall from standing height) exclusion criteria: * patients with pathological hip fractures due to malignancy * cancer patients with multiple organ metastases * patients who underwent revision hip fracture surgery
treatment of cocaine dependence: comparison of three doses of dextro-amphetamine sulfate and placebo

Conditions: Cocaine-Related Disorders

Summary: dextro-amphetamine sulfate is a central nervous system stimulant that increases the release of the neurotransmitter dopamine in the brain. the purpose of this study is to further examine dose ranges of dextro-amphetamine sulfate as a treatment for cocaine dependence.

this randomized, double-blind dose study will compare the effectiveness of three active medication doses of dextro-amphetamine sulfate to placebo in the treatment of cocaine dependence. participants will be randomly assigned to one of the four following dosages of dextro-amphetamine sulfate: 0 mg, 40 mg, 60 mg, or 80 mg. participants will undergo a 2-week stabilization period followed by a 25-week study period. the study period will include administration of the stable medication dose for 21 weeks, followed by 1 week of dose reduction, and then 3 weeks without medication. all participants will receive weekly cognitive behavioral therapy and electrocardiograms. participants will be given the option to participate in a voluntary plasma blood draw during weeks 4, 8, and 20 and will be scheduled for follow-up assessments at months 1 and 3 post-treatment.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of cocaine dependence, as determined by the structured clinical interview for dsm-iv * agreement to use an adequate method of contraception for the duration of the study * electrocardiogram confirmation by a cardiologist * cocaine-positive urine test prior to study entry exclusion criteria: * high blood pressure * significant heart disease * clinically significant cardiovascular abnormality * angina * kidney, liver, or gastrointestinal disorder * current axis i disorder not related to drug use * current dependence on any drug other than nicotine * attention deficit disorder (add) or attention deficit hyperactivity disorder (adhd) * on probation or parole for reasons other than those related to drug abuse charges * pregnant or breastfeeding * sought treatment for drug dependence within 3 months prior to study entry * currently taking prescribed medications

Keywords: cocaine abuse dextro-amphetamine sulfate
effect of water exchange method on adenoma miss rates in patients undergoing selective polypectomy

Conditions: Adenoma

Summary: patients with colorectal adenomas are suggested to receive polypectomy. a substantial number of adenomas may be missed in patients with polyps found by previous colonoscopy. and water exchange (we) method may increase the detection of missed adenoma compared with traditional air insufflation (ai) colonoscopy. the investigators aim to investigate whether water exchange colonoscopy method, compared with air insufflation method, can improve the detection of missed adenomas in patients undergoing selective polypectomy.

for we method, the air pump was turned off for the full duration of insertion to avoid inadvertent air insufflations and colon elongation. residual air in the lumen was suctioned to minimize angulations at flexures. water at 37°c was infused with a pump (olympus) through the biopsy channel to confirm correct tip orientation for scope advancement. the infused water was removed predominantly by suction when the colonoscope was smoothly advanced during the insertion phase, and turbid luminal water due to residual feces was exchanged by clean water until the lumen was clearly visualized. occasionally, if it was difficult to determine whether the colonoscope tip was in the cecum, air was allowed to be insufflated for observation. if the position of the scope tip was confirmed to be not in the cecum, insufflated air would be removed by suction and the we method would be continuously used until successful intubation. for the ai method, water was not used, and air was insufflated during insertion. air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal for both methods. polyps will be removed by forceps biopsy (polyps size \<3mm), cold snare technique (3-6mm) or endoscopic mucosal resection (size≥6mm).

Eligibility criteria:
inclusion criteria: * age 18-80 patients undergoing selective polypectomy exclusion criteria: * polyps found more than 6 months * patients with polyposis syndrome or hereditary nonpolyposis colorectal cancer * patients with history of inflammatory bowel disease * patients with planning to undergo endoscopic submucosal dissection(esd) * patients not undergoing standard bowel preparation * patients with solid feces in the last stool after bowel preparation * patients considered to be high risk for bleeding during endoscopic mucosal resection (emr), e.g. using antiplatelet drugs (clopidogrel) within 5 days before the current colonoscopy * hemodynamically unstable * pregnant women * unable to provide informed consent

Keywords: water exchange colonoscopy adenoma miss rate polyps
an extension study of treprostinil palmitil inhalation powder (tpip) for pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension

Summary: the primary purpose of the study is to evaluate the safety and tolerability of the long-term use of tpip in participants with pah from studies ins1009-201 (nct04791514), ins1009-202 (nct05147805) and other lead-in studies of tpip in participants with pah.


Eligibility criteria:
inclusion criteria: * male and female participants who completed end of treatment study visit in study ins1009-201, ins1009-202, or any other lead-in pah tpip study. participants for whom the ole study was not available at the time of their completion of the lead-in study are eligible for enrolment within one year of their lead-in end of treatment visit. * complete baseline screening assessments to confirm eligibility to participate if more than 30 days have elapsed since the end of the study visit in study ins1009-201, ins1009-202, or any other lead-in pah tpip study. exclusion criteria: * initiation of parenteral administration of prostacyclin analogues (eg, tre, epoprostenol) since the completion of studies ins1009-201, ins1009-202 or other tpip studies. initiation of inhaled prostacyclin analogues (eg, tre \[tyvaso\] or iloprost) and oral prostacyclin analogues (eg, tre \[orenitram\]) or receptor agonists (eg, selexipag) are permitted if stopped 24 hours prior to the start of study drug administration. * any new ventricular or supraventricular tachyarrhythmia except for paroxysmal atrial fibrillation and any new symptomatic bradycardia. * new-onset of heart disease including left ventricular ejection fraction (lvef) ≤40% or clinically significant valvular, constrictive, or symptomatic atherosclerotic heart disease (eg, stable angina, myocardial infarction, etc). * new evidence of thromboembolic disease as assessed by ventilation/perfusion (vq) scan, pulmonary angiography, or pulmonary computed tomography (ct) scan. * active and current symptomatic coronavirus disease 2019 (covid-19) or previous severe disease and/or hospitalization due to covid-19. * interval organ transplantation. * new active liver disease or hepatic dysfunction. * interval malignancy with exception of completely treated in situ carcinoma of the cervix and completely treated non-metastatic squamous or basal cell carcinoma of the skin. * use of any investigational drug/device or participation in any investigational study within 30 days prior to screening, not including tpip of the lead-in study. * current use of cigarettes (as defined by centers for disease control and prevention \[cdc\]) or e-cigarettes: an adult who has smoked at least 100 cigarettes in his or her lifetime, who smokes either every day or some days. * participants who currently inhale marijuana (recreational or medical). note: other inclusion/exclusion criteria may apply.

Keywords: treprostinil palmitil
wrist arthroscopy during surgical treatment of distal radius fractures

Conditions: Fracture; Radius Fracture Distal

Summary: wrist arthroscopy (wa) is a potentially useful adjuvant procedure in the surgical treatment (osteosynthesis) of distal radius fractures (drfs). previous research on the contribution of wa to drf treatment has shown different results. objectives of the study: (1) validate wrist functional outcome questionnaires; (2) to determine whether arthroscopically assisted repositioning of fracture fragments in articular drfs leads to a better treatment outcome; (3) to determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in articular drfs leads to a better treatment outcome; (4) to determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in extraarticular drfs leads to a better treatment outcome. research hypotheses: (1) validated questionnaires will have satisfactory measurement properties (validity, reliability) and will be able to be used in a wa randomized controlled trial; (2) wa as an adjunct to drf osteosynthesis improves the clinical outcome of treatment. subjects: 56 female patients with indication for drf osteosynthesis aged 50-69 years divided into 2 groups: 1. examined - 28 patients with indication for drf osteosynthesis (14 patients with extraarticular drf and 14 patients with intraarticular drf) with associated wa, and 2. control - 28 patients with indication for drf osteosynthesis (14 patients with extraarticular drf and 14 patients with intraarticular drf) without associated wa. methods: as a primary outcome measure, functional outcomes of treatment will be analyzed with the disabilities of the arm, shoulder and hand (dash) score at 3 and 6 months after surgery. as a secondary outcome measures it will be analyzed pain level according to a visual analog scale (vas), preoperative and postoperative radiographic parameters of distal radius, and clinical outcomes of treatment with the mayo wrist score (mws) and patient-rated wrist evaluation (prwe) score at 3 and 6 months after surgery. expected scientific contribution: providing answers on the role of wa in the treatment of drf and associated injuries as well as its impact on treatment outcome.


Eligibility criteria:
inclusion criteria: * distal radius fractures with an indication for surgical treatment according to the ao/ota classification of patients aged 50-69 years who have signed an informed consent to participate in the research. exclusion criteria: * distal radius fractures( drf) that have an indication for surgical treatment in all patients and in patients younger than 50 and older than 69, * drf that do not have an indication for surgical treatment, * refusal to participate in the research, * inability to decide independently about participation in the research (persons under guardianship), * open fractures, * presence of severe soft tissue injuries, * infections, * poor general condition of patients and internal medicine contraindications.

Keywords: arthroscopy radius fractures surveys and questionnaires treatment outcome wrist
a long-term, extended treatment study of aripiprazole in pediatric patients with schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to investigate the safety and efficacy of aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over a period of 52 weeks in subjects who complete a short-term treatment study of pediatric patients (aged 13-17 years) with schizophrenia (031-09-003 study).


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of schizophrenia (295.30, 295.10, 295.20, 295.90, 295.60), according to dsm-iv-tr * male and female patients aged 13-17 years * patients completing the 031-09-003 study * patients who, in addition to their legal guardian, provide written informed consent, having understood the details of this study * inpatient or outpatient status exclusion criteria: * patients who have a diagnosis of any other disease except schizophrenia, according to dsm-iv-tr * patients who have been compulsorily admitted to hospital * patients with mental retardation * patients with thyroid disorder * patients who fall under a contraindication listed in the abilify package insert * patients with a serious hepatic, renal, cardiac or hematopoietic disorder * patients with a history or a complication of organic brain disorder or convulsive disorder such as epilepsy * patients with a history or a complication of diabetes and patients who fall under any of the following: fasting blood glucose level ≧ 126 mg/dl, non-fasting blood glucose level ≧ 200 mg/dl, hba1c ≧ 6.5% * patients with a history or a complication of suicide attempt, suicidal thought or self-harm * patients with a score of ≧2(mild) on part1 evaluation of cgi-ss * patients with a history or a complication of malignant syndrome, tardive dyskinesia or paralytic ileus * patients in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition * patients with a history or a complication of water intoxication * patients with parkinson's disease * pregnant women, parturient women, nursing women, women of childbearing potential who wish to become pregnant during this trial. however, women of childbearing potential who are practicing an appropriate method of contraception (refer to 8.6) and have a negative pregnancy test result are eligible for inclusion in this study. * study enrollment is otherwise judged to be inappropriate by the investigator or subinvestigator

Keywords: schizophrenia, pediatric patients
pulmonary rehabilitation and inspiratory muscle training (imt) for patients following lung transplantation

Conditions: Lung Transplantation

Summary: lung transplantation (lt) is now an established treatment option for patients with a wide variety of end-stage lung diseases- aims to improve quality of life and survival. pulmonary rehabilitation (pr) is widely recognized as an important component of care of patients with chronic obstructive pulmonary disease (copd), it improves dyspnea, exercise tolerance, quality of life, and reduces healthcare resource utilization. the goal of pulmonary rehabilitation following lung transplantation is to enhance the physiological and functional benefits resulting from surgery. inspiratory muscle training (imt) is defined as any intervention with the goal of training the inspiratory muscles. imt can improve inspiratory muscles strength, endurance and exercise capacity in adults with copd. imt provides additional benefits to patients undergoing pr program and is worthwhile even in patients who have already undergone a general exercise reconditioning (ger) program. imt will provide additional benefits (together or without) pr to patients following lung transplantation. no formal guidelines exist regarding the optimal methods of exercise training component of pulmonary rehabilitation for patients recovering from lung transplantation. this study will evaluate the unique influence of imt in patients following lung transplantation.

the post lung transplant patients will participate in a rehabilitation program for 6 months. participants in the proposed study will belong to one of four intervention groups: 1. conventional or regular pulmonary rehabilitation program alone(an exercise program that consist 3 main components: aerobic conditioning, resistance training, and flexibility exercises). 2. very low load imt(sham imt) alone. 3. conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold imt. 4. targeted inspiratory resistive or threshold imt alone.

Eligibility criteria:
inclusion criteria: * post lung transplant patients attending the pulmonary institute , will be invited to participate,they will be co-operative and able to perform spirometry; and other lung tests. * patients will be stable clinically,for at least one month,the patients will be all new to an imt program. exclusion criteria: * patients with cardiac disease,poor compliance,or requirement of supplemental oxygen.

Keywords: inspiratory muscle training pulmonary rehabilitation
using chws and hpv home tests to increase cervical cancer screening in minority populations

Conditions: Cervical Cancer

Summary: caribbean immigrants (both hispanics and blacks from haiti) are less likely to be screened for cervical cancer than the general population. one promising approach is outreach strategies that employ community health workers (chws). yet even in well structured chw programs, many women remain unscreened. in our nci community networks sponsored project, we are testing an approach that combines chws with self sampling for the human papilloma virus (hpv) as a screening strategy among such hard to reach populations.

building on our existing community partnerships, we propose a randomized cbpr study among 600 women in three underserved communities in miami-dade county to determine optimal approaches to increase cervical cancer screening among caribbean and other underserved women. the study is a three arm study with 200 women randomized at each site over 3 years. women in the control group would be exposed to nci approved culturally and linguistically appropriate outreach and educational materials on cervical cancer screening. our two specific aims are 1) to determine if as compared to our control group, women randomized to the community health worker intervention group consisting one on one health education and facilitation of referrals to existing screening programs results in increase proportion of women who are screened 2) to determine if as compared to the chw group, women randomized to a chw intervention with the addition of a home based self-sampling strategy results in an additional increase in proportion of women who are screened versus the chw group without hpv sampling. secondary outcomes include comparisons of a) measures of access to care (health insurance, having a usual source of care, and visit to provider in six months) b) cost of providing the intervention in order to determine the cost of recruiting an individual woman into screening c) among women having abnormal screens, time to follow-up and further testing.

Eligibility criteria:
inclusion criteria: * haitian, hispanic or african american women * ages 30-65 years * not having had a pap smear in the last three years * live in miami-dade county exclusion criteria: * having had a hysterectomy * history of cervical cancer * plan to move out of the neighborhood during the next six months * are enrolled in any other cancer prevention/outreach related study

Keywords: screen cervical, cancer hpv women community health workers hispanic/ latinas haitian