Kornimate/medical-research-clean huggingface dataset:
a study of tilvestamab (bgb149) in relapsed, platinum-resistant, high-grade serous ovarian cancer (hgsoc) participants

Conditions: Ovarian Neoplasms

Summary: the primary purpose is to assess the safety and tolerability of tilvestamab following iv administration of multiple doses to participants with hgsoc who have been treated with at least 1 complete course of platinum-based chemotherapy and whose disease has relapsed with platinum resistance (\[prr\]-hgsoc) and to determine the plasma pharmacokinetics (pk) exposure by comprehensive profiling (at single dose and steady-state) of multiple ascending doses of tilvestamab.


Eligibility criteria:
inclusion criteria: * females of non-childbearing potential at the time of provision of informed consent * ability to understand and provide written confirmation of informed consent after reading study information, discussion with the investigator, and adequate time to decide on participation * consents to storage of study-related samples and data for exploratory use * histologically confirmed hgsoc * platinum-resistant relapsed disease; defined as progressive disease based on imaging within \<= 6 months from completion of most recent regimen exclusion criteria: * primary platinum-refractory disease (ie, progression during the first platinum regimen or within 4 weeks of completion of the first platinum regimen) with rapid progression and life-threatening disease manifestation * life expectancy \< 6 months * concurrent anticancer therapy * participants who are breastfeeding * known uncontrolled central nervous system metastases. participants without known brain metastases do not require radiological imaging prior to enrolment
a clinical investigation of the c2a-taper™ acetabular system

Conditions: Osteoarthritis; Avascular Necrosis; Congenital Hip Dysplasia; Traumatic Arthritis

Summary: the objective of this study is to gather clinical and survivorship information for the c2a-taper™ acetabular system, a ceramic-on-ceramic hip articulating system.

study design: phase 1 sites will collect the following types of data: clinical-total harris hip score, radiographic evaluation- measurements on acetabular and femoral components survivorship-removal/revision of one or more components (i.e. liner, head, shell and/or stem) safety- all other adverse events follow-up visit schedule * 6 week ± 2 weeks * 6 month ± 1 month * 1 year ± 3 months * 2 years ± 3 months * 3 years ± 3 months * 4 years ± 3 months * 5 years ± 3 months phase 2: patients continue to be followed on an annual basis (years 6-10) via mail. a self assessment form is sent directly to the subject on an annual basis starting in the 6th post-operative year.

Eligibility criteria:
inclusion criteria: * skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis exclusion criteria: * patients with: osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, vascular insufficiency, muscular atrophy, and neuromuscular disease

Keywords: hip arthroplasty hip arthritis
oocyte donor application discrepancies

Conditions: Infertility

Summary: retrospective observational study comparing information received on inception central donor recruitment's standardized online egg donor application compared to information reported during a genetic risk assessment (gra) consultation with a certified genetic counselor with contracted third party genetic counseling service, genescreen. all donor applicants completing a full application with inception's central donor recruitment and a gra consultation with genescreen will be included.

background: historically, it has been considered sufficient to have an egg donor applicant complete a written application that is reviewed by an egg donor program for acceptability. in 2021, asrm put forth recommendations that "family history review and assessment of donors should be performed by a certified genetic counselor". in 2022, inception central donor recruitment (cdr) established a process for screening donor applicants that included genetic risk assessment (gra) with a certified genetic counselor. this study seeks to illustrate the discrepancies between personal and family history information documented on a standardized online application compared to a gra consultation with a certified genetic counselor. objectives: investigate the rate of new information obtained at gra which was not included in the full application, as follows: * new information with no change to health risk assessment (i.e. change in number of relatives) * new information with a change to health risk assessment (i.e. known or suspected diagnoses for od or family), with one of the following decisions * still acceptable/approved for clinic (ie new multifactorial condition reported, such as diabetes) * decline based on tpn internal guidelines alone (ie meets nccn criteria for genetic testing) * decline based on asrm guidelines (ie first degree relative with a major malformation) hypothesis: information obtained through gra with a certified genetic counselor will lead to more detailed and accurate assessment of donor applicant eligibility. some information obtained through gra, which was not apparent on application, will lead to a donor applicant being declined based on internal prelude network donor screening guidelines and/or guidelines set forth by the american society of reproductive medicine.

Eligibility criteria:
inclusion criteria: * all oocyte donor applicants completing a full application with inception's central donor recruitment and a gra consultation with genescreen will be included. exclusion criteria: * not applicable
effects of intensity of early communication intervention

Conditions: Communication Disorders; Developmental Disabilities

Summary: the purpose of the study is to determine if a more intensive application of communication intervention, i.e. 5 hours per week, will result in more frequent intentional communication acts, greater lexical density, and a better verbal comprehension level than children who receive the same communication intervention only one time per week.

our research team has pioneered the development of a prelinguistic communication intervention referred to as parent responsivity education-milieu communication teaching (pre-mct). this intervention is designed to establish and enhance the development of intentional communication prior to the onset of spoken language in children with language delays and disorders. in the early stages of intervention, clinicians target children's use of gestures, vocalizations, and eye contact to produce more frequent and more complex nonverbal communication acts. as the children develop, goals shift to the direct teaching of words and sentence structures. our preliminary research using randomized experimental designs has tested the effects of the intervention when delivered in a very small 'dose', averaging just over one hour per week for six months. this standard dose has led to significant but modest effects in the children's use of intentional communication and early language, such that it could be adopted by speech-language pathologists as part of standard care. unfortunately, the early benefits have not always been maintained 6 and 12 months after the therapy phase ends and have not always benefitted all children. this research is a test of the hypothesis that a more intensive application of the intervention will have dramatically more positive outcomes than the standard dosage.

Eligibility criteria:
inclusion criteria: * must produce at least one intentional communication act during administration of the communication and symbolic behavior scale * a minimum raw score of 34 or a composite score not greater than 75 on the cognitive subtest of the bayley scales of infant development exclusion criteria: * spontaneous production of more than 20 words * failure of a screening test for autism * english is not the primary language spoken in the home * corrected hearing or corrected vision is not within normal limits
clinical study on screening of nursing evaluation indicators of stroke patients

Conditions: Stroke

Summary: the purpose of this study was to use delphi method to screen the nursing observation indexes of patients with stroke, and to screen the sensitive indexes with high correlation with the severity of stroke.it is used to guide nursing staff to observe the nursing of patients with cerebral apoplexy.


Eligibility criteria:
inclusion criteria: ①according to the diagnostic criteria which was revisied in 1996 at the fourth national cerebrovascular disease conference,patients were diagnosed with cerebral apoplexy through computerized tomographic scanning or magnetic resonance imaging examination. ②patients who volunteer to participate in the study and sign the consent form. exclusion criteria: ①patients with other serious diseases, such as tumor, grade 2 or above of cardiac function. ②had a history of mental illnes.

Keywords: stroke；nursing assessment；condition of a patient；deterioration；
teledermatology and modulation of antibiotic dose in acne vulgaris

Conditions: Acne Vulgaris

Summary: to see if teledermatology can be used to reduce antibiotic burden in patients on doxycycline or minocycline for acne vulgaris

the investigators are going to ascertain if antibiotic burden can be reduced with tele dermatology use. there are two arms of the study: 1. feedback group 2. non feedback group all subjects will be randomised to either group, all subjects will take photos of their face and answer questions at baseline, visit 2 (1 month), visit 3 (2 months), visit 4 (3 months). the investigators will then use measurements of acne grading (patient grading, investigator global assessment, lesion counting, global acne grading) to reduce/taper antibiotics in the feedback group.

Eligibility criteria:
inclusion criteria: * subjects aged 15 years and older * subjects who have been prescribed doxycycline or minocycline by their physician for acne vulgaris but have not initiated treatment yet. exclusion criteria: * subjects who have used isotretinoin in the last 6 weeks * those who have used oral antibiotics within the last 4 weeks * those who have been initiated or changed brand of oral contraceptive pill within the last one month. * those subjects who cannot engage with the teledermatology platform * prisoners * adults unable to consent
effects of tens during the performance of a therapeutic exercise protocol in individuals with knee osteoarthritis.

Conditions: Osteoarthritis, Knee

Summary: research participants diagnosed with knee osteoarthritis will be randomized through a draw using sealed opaque envelopes indicating two groups: 1. therapeutic exercises + transcutaneous electrical nerve stimulation and 2. therapeutic exercises + placebo transcutaneous electrical nerve stimulation. therefore, individuals of both sexes, aged 40 years or over, with a clinical diagnosis of unilateral osteoarthritis of the knee, who present with knee pain for more than three months, morning stiffness for less than 30 minutes, crepitus, bone sensitivity and absence of palpable heat, and diagnosis established radiographically (determined by kellgren and lawrence grade 1 to 3 on scale 1 to 4). exclusion criteria are bilateral knee osteoarthritis, hip osteoarthritis, severe osteoporosis, fibromyalgia, clinical history of tumors or cancer, active inflammatory joint diseases (rheumatoid arthritis, gout), undergoing any lower extremity joint replacement, neurological disorders (parkinson's disease, stroke, multiple sclerosis, muscular dystrophies, motor neuron disease, alzheimer's disease), infected wounds or osteomyelitis in the knee region, deep vein thrombosis or thrombophlebitis, sensory changes in the lower limbs, cognitive impairment, and cardiopulmonary disorders that may prevent or limit the execution of exercises, use of a walking assistance device, history of recent trauma to the knee, having undergone any form of treatment involving physiotherapy, intra-articular corticosteroids, anti-inflammatories or chondroprotective within the six months before the start of interventions.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of unilateral osteoarthritis of the knee * presenting knee pain for more than three months * morning stiffness for less than 30 minutes * crepitus, bone tenderness, and absence of palpable heat. exclusion criteria: * bilateral knee osteoarthritis, hip osteoarthritis * severe osteoporosis * fibromyalgia * medical history of tumors or cancer * active inflammatory joint diseases (rheumatoid arthritis, gout), * undergoing any lower extremity joint replacement * neurological diseases (parkinson's disease, accident cerebral vascular, multiple sclerosis, muscular dystrophies, motor neuron disease, alzheimer's disease) * infected wounds or osteomyelitis in the knee region * deep vein thrombosis or thrombophlebitis * sensory changes in the lower limbs * cognitive and cardiopulmonary impairment that may prevent or limit performing the exercises * using a walking assistance device * having a history of recent trauma to the knee, * having undergone any form of treatment involving physiotherapy * intra-articular corticosteroids, anti-inflammatories, or chondroprotective in the six months before the start of the interventions.
left atrial appendage occlusion study iii

Conditions: Cardiac Surgery With Cardiopulmonary Bypass; Atrial Fibrillation

Summary: atrial fibrillation (af) is a common heart rhythm disorder that leads to one-sixth of all strokes. prevention of strokes in af is achieved through the use of blood thinners such as coumadin. although these blood thinners are effective, they are limited by the risk of serious bleeding, by physician and patient reluctance to use, and by noncompliance and discontinuation. the left atrial appendage is a structure on the upper chamber of the heart that is the most common source of stroke in patients with af. this structure is easily accessible during open heart surgery for removal, and has been an area of interest for stroke prevention. however, there is currently no strong evidence that removing it works. the laaos iii trial will randomly (like the flip of a coin) assign patients with af undergoing heart surgery for other reasons to have the left atrial appendage removed or not. these patients, other than this small procedure which has been shown to be quite safe, will be treated in the usual manner. the full study of 4700 patients, followed for an average of 4 years, will determine if removing the left atrial appendage can reduce stroke and other complications on top of usual therapy. a positive study will change the way heart surgery is performed on af patients and results in a large reduction in the number of strokes in a large population. further, it will promote further research into this approach that could be applied beyond af patients undergoing heart surgery.


Eligibility criteria:
inclusion criteria: 1. greater than 18 years of age 2. undergoing a clinically indicated cardiac surgical procedure with the use of cardiopulmonary bypass 3. have a documented history of atrial fibrillation or atrial flutter 4. cha2ds2-vasc score ≥ 2 5. have provided informed consent exclusion criteria: 1. patients undergoing off-pump cardiac surgery 2. patients undergoing any of the following procedures: * heart transplant * complex congenital heart surgery * sole indication for surgery is ventricular assist device insertion * previous cardiac surgery requiring opening of the pericardium * mechanical valve implant 3. patients who have had a previous placement of a percutaneous left atrial appendage closure device

Keywords: cardiac surgery left atrial appendage atrial fibrillation stroke non-cns systemic embolism
a study of oral btd-001 in adults with idiopathic hypersomnia

Conditions: Idiopathic Hypersomnia

Summary: this is a randomized, placebo-controlled, double-blind, crossover study of oral btd-001 in adults with idiopathic hypersomnia.

this is a randomized, placebo-controlled, double-blind, crossover study of oral btd-001 in adults with idiopathic hypersomnia (ih). the objectives of this study are two-fold: 1) to evaluate the efficacy of btd-001 in subjects with ih as reflected by changes in cognitive, sleep, functional, and quality-of-life measures and 2) to characterize the safety and tolerability of oral btd-001 administered to subjects with ih.

Eligibility criteria:
inclusion criteria: * males or females age 18 to 70 years old * onset of hypersomnia between age 10 and 30 years of age * an epworth sleepiness scale score of greater than or equal to 11 * able to comply with requirements for concomitant medications and consumption of caffeine, alcohol, tobacco and nicotine (if on stimulants, agree to adhere to stable regimen throughout the trial) * females with a negative pregnancy test and who are non-lactating * sexually active females of childbearing potential must be willing to use a highly effective method of birth control * sexually active males must have a vasectomy or use condoms exclusion criteria: * history of any disorder causing hypersomnia other than ih * evidence of circadian-rhythm disorder * sleep apnea syndrome * use of cpap * obese subjects with bmi greater than or equal to 35kg/m2 * history of or current seizure disorder or history of syncope, unexplained loss of consciousnesses or seizure in the past 3 years as well as any past history of benzodiazepine and/or barbiturate and/or alcohol-related withdrawal seizures * columbia-suicide severity rating scale (c-ssrs) findings consistent with significant history of or current suicidal ideation or behavior * subjects who fail to wash out medications for ih or any other prohibited medications * positive toxicology screen test during the screening or baseline visits. * clinically significant abnormal findings from physical, electrocardiogram (ecg) or laboratory assessments at screening * history of or current significant pulmonary, cardiac, neurological or psychiatric disease, substance dependence, porphyria, malignancy (with exception of local cutaneous squamous or basal cell carinomas or local cervical squamous cell carcinoma resolved after resection) or hypothyroidism (unless euthyroid at screening visit and treated with a stable dose of medication for at least 3 months prior to the baseline visit). * participation in a clinical drug trial within 4 weeks of screening visit
clinical trial of epass with hot axios system

Conditions: Gastric Outlet Obstruction

Summary: a prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with eus-guided double-balloon-occluded gastrojejunostomy bypass (epass)

primary objective is to investigate the safety and effectiveness of the axios™ lumen-apposing metal stent used in the eus-guided double-balloon-occluded gastrojejunostomy bypass (epass) for the management of symptoms associated with gastric outlet obstruction (goo) secondary to malignant unresectable neoplasm. primary endpoint is gooss 3 rate without mae at 30 days post procedure.

Eligibility criteria:
inclusion criteria: * unresectable malignant duodenal obstruction confirmed by biopsy * eligible for endoscopic intervention * gooss score of 0 or 1 * 18 years of age or older * willing and able to comply with the study procedures or legally authorized representative (lar) must provide written informed consent form (icf) to participate in the study exclusion criteria: * goo symptoms are not expected to improve after the index procedure * life expectancy is about 3 months or less, which is not assumed applicable for surgical gj * prior metallic stent placement for goo * contraindicated to surgery and general anesthesia * neoplasm invading the target site of puncture in gastric and/or jejunum * abnormal coagulation inr \> 1.5 and not correctable (per the discretion of the physician) or who require continuous complete anticoagulation * bleeding diathesis * altered anatomy of the upper gastrointestinal tract due to surgery of esophagus, stomach and duodenum that might preclude endoscopic drainage * presence of ileus caused by peritoneal carcinomatosis, or expected to present within 30 days post procedure * intervening gastric varices or vessels at the target site of stent insertion * ascites that may interfere the safety of the index procedure * biliary tract obstruction requiring treatment at the same day of the index procedure * allergic to any of the device materials * contraindications to use of electrosurgical devices * pregnancy, breastfeeding or intending to become pregnant during the study period * subject is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the study sponsor) * vulnerable subject * subject has other reason not to be eligible for this study per investigators' discretion * guidewire doesn't cross the area of goo * ep-db doesn't advance to the target site in jejunum * the distance between the gastric wall and jejunal wall when visualized on ultrasound after saline is introduced into the space between the two inflated balloons of ep-db is deemed about 2 cm or more
evaluation of safety and efficacy of mersina, an ayurvedic formulation: a double blind, placebo controlled study in type 2 diabetic patients with secondary failure to oral drugs

Conditions: Antihyperglycemic Effect in Type 2 Diabetic Patients With Secondary Failure to Oral Hypoglycemic Agents

Summary: to determine the safety and efficacy of an ayurvedic formulation, mersina in type 2 diabetic patients with secondary failure to oral hypoglycemic agents, a randomized double blind, single centre, study of 3 months duration was carried out.


Eligibility criteria:
inclusion criteria: secondary failure to oral hypoglycemic agents was diagnosed if the patient had hba1c levels \> 8.5% even after supplementation of maximal dose of a combination of a sulphonylurea (15 mg glybenclamide or 160 mg gliclazide or 15 mg glipizide) and metformin 1500 mg/day. exclusion criteria: patients with ketosis, diabetes related complications, hepatic or renal disease, pancreatitis, cardiac problems, uncontrolled hypertension, malnutrition and severe immune deficiency

Keywords: ayurvedic formulation type 2 diabetes mellitus secondary failure to oral hypoglycemic agents antidiabetic
study comparing tigecycline versus ceftriaxone sodium plus metronidazole in complicated intra-abdominal infection

Conditions: Appendicitis; Cholecystitis; Cross Infection; Diverticulitis; Peritonitis

Summary: this is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with ciai (complicated intra-abdominal infection). subjects with clinical signs and symptoms of ciai will be included for enrollment. subjects will be stratified at randomization for acute physiologic and chronic health evaluation scale (apache ii) score \ 10. subjects will be followed for efficacy through the test-of-cure assessment. safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours. * fever over 100.4°f (38.0°c) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain. exclusion criteria: * cancer * medicines that suppress the immune system * dialysis

Keywords: complicated intra-abdominal infection appendicitis with abscess perforated diverticulitis purulent peritonitis complicated cholecystitis