Kornimate/medical-research-clean huggingface dataset:
selective image guided resection of pathologically documented axillary lymph node metastases

Conditions: Breast Cancer

Summary: the purpose of this research study is to determine how feasible and accurate identifying and removing specific lymph nodes in the axilla (armpit) after neoadjuvant systemic therapy is when patients present with breast cancer that has spread to lymph nodes in the axilla. the specific lymph nodes removed would be determined at the time of diagnosis. if a biopsy proves that cancer has spread to a lymph node, a titanium clip will placed in it to mark it for future removal. that lymph node will be removed after systemic therapy and compared with the rest of the lymph nodes removed from that region.


Eligibility criteria:
inclusion criteria: 1. histologic diagnosis of invasive breast cancer, clinical stage t0-3 n1-3 (maximum three abnormal axillary nodes on ultrasound exam) m0. 2. core needle biopsy (or fine needle aspiration (fna)) of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative systemic therapy or surgery. clinical care marker clip placed in the abnormal axillary nodes identified at ultrasound at the time of core needle or fna of an axillary node that documented nodal disease. 3. subjects must be undergoing neoadjuvant systemic therapy (or have just completed it) prior to the surgical intervention. 4. no prior axillary lymph node surgery for pathological confirmation of axillary status. 5. no nitinol (nickel-titanium) allergy. the savi scout ® marker device contains nitinol. 6. females of childbearing potential must have a negative serum pregnancy test within 14 days prior to receipt of chemotherapy. note: females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months 7. females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 30 days after chemotherapy discontinuation. the two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets \<1% failure rate for protection from pregnancy in the product label. 8. as determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study. exclusion criteria: 1. active infection requiring systemic therapy 2. has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer. 3. any distant metastasis by imaging and biopsy (cm1) 4. patients not receiving neoadjuvant systemic therapy.
a new etiological cause for anterior cruciate ligament injury: e-scooter

Conditions: Anterior Cruciate Ligament Tear

Summary: the investigators aimed to find the relationship between e-scooter use and anterior cruciate ligament injury.

the incidence of injuries related to e-scooter use is increasing. there is no study in the literature investigating the relationship between anterior cruciate ligament injury and e-scooter use.

Eligibility criteria:
inclusion criteria: * participants with e-scooter related acl injury exclusion criteria: * participants with other acl injury etiology

Keywords: anterior cruciate ligament injuries e-scooter
evaluation of home treatment for acute psychiatric care

Conditions: Mental Disorder

Summary: the study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. patients who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual), during one year. following two years, the two treatment modalities will be analyzed in terms of inpatient days, cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics.

the study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. therefore, psychiatric patients in need of hospitalization who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual) during one year. home treatment patients are visited by a mobile and multiprofessional care team at their homes. additionally, patients without a health insurance for home treatment and patients who are directly assigned to home treatment are included in separate study groups. following two years, it will be checked whether home treatment leads to a reduction of inpatient days as a primary outcome. further outcomes such as cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics will be also analyzed.

Eligibility criteria:
inclusion criteria: * need for acute psychiatric inpatient care * residence in zurich city * health insurance for home treatment exclusion criteria: * none
korean post-marketing surveillance for xeljanz

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

Summary: the objective of this study is to identify any problems and questions with respect to the safety and efficacy of xeljanz during the post-marketing period as required by the regulation of mfds.


Eligibility criteria:
inclusion criteria: to be included in the study all patients will have received at least 1 dose of xeljanz for the treatment of the following indication as per local labelling. moderately to severely active ra in adult patients who have had an inadequate response or intolerance to previous therapy with at least 1 biological dmard. or active psoriatic arthritis (psa) who have had an inadequate response or intolerance to previous antirheumatic drugs (dmards) exclusion criteria: 1. patients with a history of hypersensitivity to any ingredients of the product. 2. patients with serious infection (eg, sepsis) or active infection including localized infection. 3. patients with active tuberculosis. 4. patients with severe hepatic function disorder. 5. patients with an absolute neutrophil count (anc) \<500 cells/mm3. 6. patients with a lymphocyte count \<500 cells/mm3. 7. patients with a hemoglobin concentration \<8 g/dl. 8. pregnant or possibly pregnant women. 9. because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption. according to contraindication on label, the investigator should discontinue the patient's treatment if the laboratory test results are as below patients with an absolute neutrophil count (anc) \<500 cells/mm3 patients with a hemoglobin level \<8 g/dl
clinical efficacy of adjuvant chemotherapy in patients with locally advanced cervical cancer who did not meet the nccn guidelines for adjuvant treatment after nact combined with surgery

Conditions: Uterine Cervical Neoplasms; Cervical Cancer

Summary: this is a prospective, phase 3 randomized controlled clinical trial. cervical cancer patients with figo stage ib3, ⅱ a2 or iib with tumor size\> 4 cm will be enrolled. patients will undergo 2-3 cycles of neoadjuvant chemotherapyradical (nact) followed by laparotomic or laparoscopic hysterectomy + pelvic lymphadenectomy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. patients meet criteria of adjuvant therapy according to nccn guideline after surgery will be weeded out, and who do not meet criteria of adjuvant therapy will be randomly selected to undergo adjuvant chemotherapy or just follow-up visit. the primary endpoint was disease-free survival (dfs) rate at 5 year. the secondary endpoints were 5-year overall survival (os), safety and quality of life.


Eligibility criteria:
inclusion criteria: 1. clinical stage ib3-iib cervical cancer (figo, 2018 standard) with the tumor diameter \> 4cm before treatment. 2. pathologically confirmed cervical cancer, including cervical squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma. 3. age：18-70 years old. 4. ecog status score ≤1; 5. wbc≥3.5\*10\^9/l, neu≥1.5\*10\^9/l, platelet≥80×10\^9 /l; ast and alt ≤1.5 times normal upper limit; total bilirubin ≤1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen ≤the upper limit of normal value. 6. well-compliance and willing to keep in touch. 7. able to sign informed consent, including complying with the requirements and restrictions listed in the informed consent (icf) and this protocol. exclusion criteria: 1. after 2-3 cycles of neoadjuvant chemotherapy, patients do not undergo laparotomic or laparoscopic extensive hysterectomy + pelvic lymph node dissection with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. 2. neoadjuvant chemotherapy regimens are different from postoperative adjuvant therapy regimens. 3. postoperative high risk factors: ① lymph node metastasis, ② parauterine infiltration, ③ positive surgical margin. 4. postoperative risk factors meet the sedlis standard of the nccn guideline. 5. participate in other clinical trials. 6. severe diseases of other important systems and organs. 7. persons without disposing capacity. 8. drug and/or alcohol abuse. 9. unable or unwilling to sign informed consents. 10. not eligible for the study judged by researchers.

Keywords: cervical cancer nact adjuvant chemotherapy locally advanced cervical cancer
open-label, long-term safety study of avoralstat in subjects with hereditary angioedema

Conditions: Hereditary Angioedema; HAE

Summary: this is an open-label study designed to evaluate the long-term safety of prophylactic avoralstat (500 mg three times daily) when given to approximately 150 patients with hereditary angioedema (hae) for a duration of up to 72 weeks. the study will also evaluate the long-term efficacy and impact on quality of life of avoralstat prophylactic treatment.


Eligibility criteria:
inclusion criteria: * males and non-pregnant, non-lactating females age ≥ 18 years. * provide written, informed consent. * prior completion of an avoralstat therapeutic study or a confirmed diagnosis of hae type 1 or hae type 2. * access to appropriate medication for the treatment of acute hae attacks. * adequate contraception. exclusion criteria: * females who are pregnant or breast feeding. * clinically significant medical condition or medical history. * abnormal screening ecg, laboratory or urinalysis finding that is clinically significant. * investigational drug exposure within 30 days (except avoralstat). * history of or current alcohol or drug abuse. * hiv or active hbv or hcv infection.

Keywords: bcx4161 avoralstat hae hereditary angioedema prophylaxis
pharmacokinetics and bioequivalence of vycavert (10 mg hydrocodone bitartrate/325 mg acetaminophen) compared to the reference drug norco

Conditions: Healthy

Summary: this study aims to determine whether the hydrocodone and acetaminophen exposures following oral dosing of vycavert are comparable to those following oral dosing of norco.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant disease * history of obstructive sleep apnea * life time history and/or recent evidence of alcohol and/or drug abuse

Keywords: pharmacokinetics bioequivalence hydrocodone acetaminophen moderate to moderately severe pain
sterol and isoprenoid disease research consortium: smith-lemli-opitz syndrome

Conditions: Smith-Lemli-Opitz Syndrome

Summary: the purpose of this study is to learn about smith-lemli-opitz syndrome (slos). slos is an inherited condition that is caused by the body not making an enzyme as it should. the body needs the enzyme to help make cholesterol. slos can cause many health problems including slow growth and development, eating disorders, sleep disorders, behavior disorders, and eye diseases. severe slos leads to birth defects and mental retardation and in many cases early death. the investigators plan to measure cholesterol and other sterol levels, perform clinical observations, whole body testing and imaging (brain mris), to learn more about the disease and its progression, differences in the clinical features among individuals with slos, and look at the effect of cholesterol supplementation in this condition. the study is an interventional study to characterize disease progression and correlations between clinical, biochemical and physiological features of the disease. the main hypothesis is that dietary cholesterol supplementation does not improve features of slos related to the brain (e.g. iq, behavior).

smith-lemli-opitz syndrome (slos) is a disorder of cholesterol synthesis, or production. it is caused by mutations in the dhcr7 gene which encodes for 7-dehydrocholesterol- δ7-reductase, an enzyme necessary for the production of cholesterol in the body. affected individuals exhibit multiple malformations and mental retardation. the features of slos are thought to be primarily related to cholesterol deficiency and accumulation of cholesterol precursors. however, the clinical phenotype is not well characterized, the biochemical pathogenesis is incompletely understood, and there is no proven therapy for this devastating condition. thus our primary objective is to better define the clinical and biochemical phenotypes of the disease using a natural history study design. the study will contribute to creating a comprehensive slos patient registry, identify biomarkers that can be used for diagnostic testing, screening and outcome measures in future therapeutic trials. all patients with slos receive dietary cholesterol supplementation with the hope that cholesterol supplementation will improve the clinical manifestation of the disease. however, there is no evidence supporting a clinical benefit of cholesterol supplementation. thus a secondary objective of the study is to determine if cholesterol intake correlates with changes in whole body cholesterol homeostasis and clinical end-points.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of smith-lemli-opitz syndrome (slos) * males and females of all ages * willing and able to travel to ohsu or another stair site exclusion criteria: * subject does not have smith-lemli-opitz syndrome (slos)

Keywords: slos
development and preliminary trial of a brief, portable health intervention for rural sexual minority emerging adults

Conditions: Depression; Suicidality; Substance Abuse; HIV; Minority Stress

Summary: the purpose of this study is to test the feasibility of writing interventions specifically designed for lesbian, gay, and bisexual (lgb) emerging adults (ages 18-29) that are aimed at improving the outcomes: depression, suicidality, substance abuse and hiv risk behaviors.

this study is considered the third part ("phase 3") of a larger study where parts one and two were designed to utilize elicitation focus groups to develop effective intervention materials (phase 1) and then refine the developed materials through structured interviews (phase 2). phase 3 will test feasibility and assess early signs of efficacy of writing interventions. to do this, participants will be randomized to one of three arms (one arm will serve as control). those that choose to participate will be asked to complete outcome measures (depressive symptoms, suicidality, use of alcohol and illicit drugs, hiv risk behavior) and measures of proposed mediators (self-reported and biological stress, behavioral and emotional self-regulation) and moderators (e.g., social support, identity centrality) at baseline, post-intervention, and three-month follow-up. in addition, structured interviews with 15 intervention participants will be used to refine study procedures as the investigators scale up this intervention for a future randomized controlled trial (rct).

Eligibility criteria:
inclusion criteria: * self-identify as lesbian, gay, or bisexual * live in washington county, tennessee (tn), or any of its 6 contiguous counties in northeastern tn * have personal internet access * hair at least 2cm in length exclusion criteria: * failure to meet inclusion criteria

Keywords: expressive writing minority stress lesbian gay bisexual
efficacy of flow restrictors in limiting access of liquid medicines by young children

Conditions: Enhanced Child-safety Packaging

Summary: this study aimed to assess whether adding flow restrictors, adapters added to the neck of a bottle to limit the release of liquid, affects the proportion of preschool-aged children who can access liquid bottle contents, the amount accessed, and the time required for children to empty the bottles compared with traditional bottles without flow restrictors.

unsupervised ingestion of medications by young children is an important public health concern, leading to tens of thousands of emergency department visits and many more calls to poison control centers each year. current knowledge on the specific circumstances in which young children gain access to medications is limited; however, a number of studies have shown that improper replacement of child-resistant packaging (crp) by a caregiver leads to a substantial number of these incidents. beginning in 2011, several pharmaceutical manufacturers introduced flow restrictors on over-the-counter (otc) infants' acetaminophen; however, the efficacy of flow restrictors in limiting accessibility of liquid medicines by young children has not been formally assessed. this study sought to determine whether adding flow restrictors, adapters added to the neck of a bottle to limit the release of liquid, to liquid medicine bottles can provide additional protection against unsupervised medicine ingestions by young children. a modified version of the standard child test protocol for re-closeable packages outlined in the poison prevention packaging act (pppa protocol) was used to assess the efficacy of flow restrictors in limiting children's access to liquid medicines. preschool-aged children participated in two 10-minute trials in which they were asked to try to "get everything out" of bottles filled with test liquid (a food product with similar flow characteristics to liquid medicine). randomized block design was used to assign specific bottles to participants. each child tested an uncapped bottle with a flow restrictor (fr-bottle) for one trial (1 of 3 designs randomly assigned). for the other trial, the child tested a control bottle (a traditional bottle either no cap or an incompletely-closed child-resistant cap). the amount of liquid the child removed from each bottle was measured and the time required to empty bottles was recorded. if flow restrictors limit the amount of liquid a young child can access, even when the outer child-resistant cap is not fully secured, their use could potentially be expanded to other liquid medicines.

Eligibility criteria:
inclusion criteria: * attends one of the participating preschools * is between 36 - 59 months of age * is an english speaker exclusion criteria: * has an obvious or overt, temporary or permanent, injury, illness, or physical or mental disability * has known allergies/restrictions to ingesting any ingredients in the test liquid

Keywords: child injury child-resistant packaging pediatric poisoning medication safety injury prevention
fight inflammation to improve outcome after aneurysmal subarachnoid hemorrhage

Conditions: Aneurysmal Subarachnoid Hemorrhage

Summary: aneurysmal subarachnoid hemorrhage (sah) is a fatal disease with high morbidity and mortality. while the primary injury results from the initial bleeding and cannot be influenced, secondary injury through vasospasms and delayed cerebral ischemia (dci) during the course of the disease might be a target for intervention in order to improve outcome. to date, beside the aneurysm treatment to prevent re-bleeding and the administration of oral nimodipine, there is no causal therapy available, so that novel treatment concepts are desperately needed. there are strong indications that inflammation contributes to dci and therefore poor outcome and plays a major role in sah. some studies suggest a beneficial effect of anti-inflammatory drugs like glucocorticoids (gc) in sah patient, but there are no data from randomized controlled trials proving or disproving the beneficial effect of gc, so that current guidelines do not recommend the use of gc in sah so far. this multi-center trial aims to generate the first confirmatory data in a controlled randomized fashion that dexamethasone (dex) improves the outcome in a clinically relevant endpoint in sah patients. moreover, this trial will generate first data in a secondary analysis, whether the initial inflammatory state of sah patients defines a subgroup that particularly responds to a treatment with dex.


Eligibility criteria:
inclusion criteria: 1. male or female subjects, equal or older than 18 years old 2. written consent to participate in the study by the patient or his legal representative (emergency inclusion by next of kin or consultant physician under the responsibility of the principal investigator is possible) 3. confirmed diagnosis of aneurysmal sah and onset within 48 hours before inclusion. exclusion criteria: 1. sah due to any other cause than aneurysm rupture (e.g. traumatic, arteriovenous malformation (avm), fistula, dissection) 2. any condition that, in the judgement of the investigator, could impose hazards to the patient if study therapy is initiated or affects the participation of the patient in the study 3. patients with obvious evidence of irreparable brainstem or thalamic injury 4. patients with foreseeable difficulties to attend follow-ups adequately 5. subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial 6. current positive pregnancy test (e.g. β-hcg test in serum) 7. known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure 8. severe infectious diseases 9. known angle-closure or open angle glaucoma 10. known ulceration in the gastro-intestinal tract 11. history of gastro-intestinal bleeding 12. long-term treatment with corticosteroids prior sah