Kornimate/medical-research-clean huggingface dataset:
the effect of scheduled ripcord removal on the outcomes of baerveldt 350 implants

Conditions: Glaucoma

Summary: the purpose of this study is to compare the post-operative complication rates and surgical outcomes in patients with a baerveldt 350 implant following scheduled rip-cord removal in clinic at post-operative week 3 versus spontaneous tube opening. patients age 18 or greater with uncontrolled glaucoma and scheduled to undergo their first superotemporal baerveldt 350 implant will be recruited and randomized at the time of enrollment to either scheduled ripcord removal at post-operative week 3 or no ripcord removal. incidence of complications will be documented and compared between the 2 groups. the final intraocular pressure control between the 2 groups will also be compared in a secondary outcome analysis. this study will help to establish post-operative management guidelines to minimize complications and improve intraocular pressure lowering success following baerveldt 350 implantation.


Eligibility criteria:
inclusion criteria: * men or women aged 18 years and older at screening. there is no upper age limit. * inadequately controlled glaucoma refractory to maximum therapy * suitable candidate for baerveldt-350 implant in the superotemporal quadrant in the study eye, which the physician deems as medically necessary. * capable and willing to provide consent exclusion criteria: * unable or unwilling to provide consent * any previous ocular surgery other than cataract extraction or trabeculectomy * any previous ocular surgeries in the study eye preventing placement of the baerveldt-350 implant in the superotemporal quadrant * any abnormality other than glaucoma in the study eye that could affect tonometry. * presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study. * monocularity (where best corrected visual acuity in the non-operative eye is worse than 20/200) * any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * known pregnant or breastfeeding women

Keywords: glaucoma drainage device baerveldt 350 ripcord complications
thalidomide plus interferon alfa in treating patients with progressive liver cancer that cannot be surgically removed

Conditions: Liver Cancer

Summary: phase ii trial to study the effectiveness of thalidomide plus interferon alfa in treating patients who have progressive liver cancer that cannot be surgically removed. thalidomide may stop the growth of liver cancer by stopping blood flow to the tumor. interferon alfa may interfere with the growth of the cancer cells. combining thalidomide and interferon alfa may kill more tumor cells.

objectives: i. determine the feasibility and activity of thalidomide in patients with unresectable hepatocellular carcinoma. ii. evaluate the toxicity of thalidomide in these patients. iii. assess the use of interferon alfa in patients who develop disease progression while being treated with thalidomide. outline: this is a multicenter study. patients receive oral thalidomide once daily. patients on a stable dose of thalidomide for at least 4 weeks with evidence of progressive disease receive interferon alfa subcutaneously twice daily. treatment continues in the absence of disease progression after initiation of interferon alfa therapy or unacceptable toxicity.

Eligibility criteria:
disease characteristics: * histologically confirmed hepatocellular carcinoma or * diagnosis of hepatocellular carcinoma based on characteristic mass and alpha-fetoprotein greater than 500 in the setting of known cirrhosis or chronic hepatitis b or c * measurable disease * at least 20 mm in one dimension * not amenable to curative surgical resection patient characteristics: age: * 18 and over performance status: * ecog 0-2 hematopoietic: * absolute neutrophil count greater than 1,200/mm\^3 * hemoglobin at least 8.0 mg/dl * platelet count at least 25,000/mm\^3 hepatic: * bilirubin no greater than 5 mg/dl * liver function tests no greater than 5 times normal renal: * creatinine no greater than 1.5 mg/dl other: * not pregnant or nursing * negative pregnancy test * regardless of fertility status: * all women (unless they have undergone hysterectomy or have been amenorrheic or postmenopausal for at least 2 years) must use at least 1 highly active method of contraception and 1 additional effective method of contraception at least 4 weeks before, during, and for at least 4 weeks after study * all men (even if they have undergone a successful vasectomy) must use effective barrier contraception during and for at least 4 weeks after study * no other medical condition that would preclude study * no other prior malignancy in past 5 years except curatively resected basal cell carcinoma of the skin or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: * no more than 1 prior biologic therapy regimen * no prior interferon or thalidomide for hepatocellular cancer chemotherapy: * no more than 1 prior chemotherapy regimen other: * no concurrent barbiturates or alcohol

Keywords: localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma
bez235 trial in patients with advanced endometrial carcinoma

Conditions: Endometrial Cancer

Summary: this is an open label and single arm study to investigate the safety and efficacy of bez235 in adult women with endometrial carcinoma whose disease progressed (or recurred) while on or after first-line antineoplastic treatment for advanced endometrial carcinoma.


Eligibility criteria:
inclusion criteria: * female ≥ 18 years * histological confirmed diagnosis of advanced endometrial carcinoma with available tissue specimen, either archival tissue or fresh formalin fixed tumor biopsy * objective and radiologically confirmed progression of disease after prior first-line treatment * recovery (to grade ≤ 1) from all clinically significant toxicities related to prior therapies (except alopecia) with adequate bone marrow and organ functions * at least one measurable lesion as per recist * eastern cooperative oncology group (ecog) performance status ≤ 2 exclusion criteria: * previous treatment with pi3k and/or mammalian target of rapamycin (mtor) inhibitors * more than one line of prior treatment for advanced or metastatic disease * active uncontrolled or symptomatic central nervous system (cns) metastases * concurrent malignancy or malignancy in the last 3 years prior to start of study treatment * wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to enrollment in this study * active cardiac disease (e.g. left ventricular ejection fraction (lvef) \ 480 msec on screening electrocardiogram (ecg), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias) * inadequately controlled hypertension * impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bez235 * drugs with a known risk to induce torsades de pointes, moderate and strong inhibitors or inducers of cyp3a4, warfarin and coumadin analogues, luteinizing hormone-releasing hormone (lhrh) agonists * pregnant or nursing (lactating) woman other protocol-defined inclusion/exclusion criteria may apply

Keywords: endometrial cancer, uterine cancer, pi3k, mtor, targeted therapy
interrupted versus continuous subcuticular skin suturing in elective cesarean section.

Conditions: Cesarean Section Wound

Summary: non-diabetic pregnant women who undergo elective cs will be randomized into two groups: group i included women who has their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group ii included women who has their skin closed with subcuticular continous suture using the same suture material

non-diabetic pregnant women who undergo elective cs will be randomized into two groups: group i included women who had their skin closed with subcuticular interrupted mattress suture using non-absorbable polypropylene, and group ii included women who had their skin closed with subcuticular continous suture using the same suture material.

Eligibility criteria:
inclusion criteria: * 18 years or older * overall good health * elective cesarean section asa class 1 or 2 exclusion criteria: * allergy to synthetic suture materials * diabetes whether gestational or pregestational * use of steroid or immunosuppresive medication within last 6 month of procedure * skin sepsis or systemic fever * bmi \> 35 * history of keloid or hypertrophic scar formation or dermatologic conditions known to impair wound healing asa class 3 or 4
misoprostol versus oxytocin for prevention of post partum hemorrhage

Conditions: Post Partum Hemorrhage

Summary: post partum hemorrhage (pph) is one of three main causes of death in pregnant women. oxytocin is widely used for prevention of pph. some studies suggested misoprostol as an alternative treatment when oxytocin isn't available. the aim of this study is to compare the safety and efficacy of oxytocin and misoprostol for prevention of pph.

in a double blind randomized controlled trial 400 pregnant women who has vaginal delivery at shariati hospital are assigned into two groups either to receive 20 unite oxytocin in 1000cc ringer and 2 placebo tablet or 400mcg oral misoprostol and 2cc normal saline in 1000cc ringer.

Eligibility criteria:
inclusion criteria: * were women with singleton pregnancy * with cephalic presentation * who had nvd spontaneously or by induction exclusion criteria: * placenta previa * placental detachment * coagulation problems * previous cs * macrosomia * polyhydramnios * and uncontrolled asthma

Keywords: misoprostol oxytocin post partum hemorrhage (pph) third stage of labour
the effect of embryo culture under a continuous co2 setting versus a sequential co2 setting

Conditions: Infertility

Summary: the purpose of this study is to determine if embryo culture under a single co2 setting improves blastocyst formation rate.

following enrollment, patients will undergo ovarian stimulation and oocyte retrieval per routine as previously consented to at the clinic. ivf stimulation protocol will be at the discretion of the patient's individual provider, per routine. intracytoplasmic sperm injection (icsi) will be performed and embryos will be cultured to the blastocyst stage per routine. there are no changes to the embryology care itself, the only difference within the study is the co2 level within the incubator pending the patient's randomization.

Eligibility criteria:
major inclusion criteria for participants: 1. patients undergoing ivf stimulation cycle with plan for subsequent fet major exclusion criteria for participants: 1. all patients who do not voluntarily give their written consent for participation 2. male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable) 3. use of surgical procedures to obtain sperm
phase ii clinical study of befotertinib in egfr non-classical mutant nsclc

Conditions: NSCLC (Non-small Cell Lung Cancer)

Summary: this is a prospective, multi-cohort, single-arm phase ii clinical trial evaluating the efficacy and safety of befotertinib, a third-generation egfr tyrosine kinase inhibitor (tki), in patients with advanced or metastatic non-small cell lung cancer (nsclc) harboring egfr non-classical mutations. the study comprises two independent cohorts: cohort 1: patients with egfr uncommon mutations (g719x, l861q, or s768i). cohort 2: patients with egfr exon 20 insertion mutation primary endpoint: objective response rate (orr) assessed by recist 1.1. secondary endpoints: disease control rate (dcr), duration of response (dor), progression-free survival (pfs), overall survival (os), and safety profile (ctcae v4.03).


Eligibility criteria:
inclusion criteria: * age ≥18 years, ecog performance status 0-2 * histologically confirmed locally advanced/metastatic nsclc * documented egfr mutations: cohort 1 (g719x/l861q/s768i) or cohort 2 (exon 20 insertion) * no prior egfr-tki therapy * progression or intolerance to ≥1 line of platinum-based chemotherapy -≥1 measurable lesion per recist 1.1 exclusion criteria: * previous egfr-tki treatment * active cns metastases (asymptomatic patients with stable lesions allowed) * severe cardiovascular disease (e.g., qtc ≥450 ms, myocardial infarction within 6 months) * active hbv/hcv/hiv infection * pregnancy or lactation
orbital radiotherapy in grave's ophthalmopathy 1 week vs 2 weeks (orago-1 trial)

Conditions: Thyroid Associated Ophthalmopathy

Summary: thyroid ophthalmopathy, also known as thyroid eye disease or graves' ophthalmopathy, is a condition characterized by inflammation and swelling of the tissues around the eyes, often accompanied by protrusion of the eyeballs. this condition can lead to significant discomfort, visual disturbances, and in severe cases, permanent vision loss. primary treatment modalities are intravenous methylprednisolone (ivmp) and other medications for patients with moderate to severe and active thyroid eye disease. in addition, external beam radiation therapy (ert) is an another treatment option in combination with ivmp. radiation therapy delivers targeted doses of ionizing radiation to the affected orbital tissues, effectively reducing inflammation. this approach is particularly beneficial for patients who may not respond adequately to steroid therapy alone or those who experience recurrent disease flares. this study will test the efficacy of a shortened treatment regimen comprising 5 sessions of ert to a standard protocol of 10 treatments. the primary aim is to ascertain the effectiveness of shorted radiation treatment while improving patients' quality of life.

the research methodology of this study involves comparing the standard protocol of 10 radiation treatments with a modified approach comprising 5 treatments of daily external beam radiation therapy (ert). the primary objective of this investigation is to assess whether reducing the number of radiation treatments while maintaining the effectiveness of the therapy can lead to improvements in the quality of life for patients with thyroid ophthalmopathy. by comparing these two treatment regimens, researchers aim to evaluate the efficacy and safety of the abbreviated radiation schedule in managing the symptoms and progression of the disease. participants enrolled in the study will be randomized into two groups: one receiving the standard 10 treatments and the other receiving the modified 5-treatment regimen of daily ert. throughout the study period, participants will undergo comprehensive assessments to monitor changes in symptoms, vision, and quality of life. these evaluations will include ophthalmic examinations, imaging studies, and patient-reported outcome measures to capture both objective and subjective measures of treatment response.

Eligibility criteria:
inclusion criteria: * patient with active moderate to severe thyroid eye disease with a cas \> 4 with/ without diplopia before starting ivmp * patient with poor response to 3 doses of ivmp (cas drop \ 3 after 3 doses of ivmp * patients with diplopia after 3 doses of ivmp * patients with graves' ophthalmopathy who have maintained euthyroidism * non-pregnant adults (aged 35 years or older) exclusion criteria: * individuals with severe hypertension or diabetic retinopathy

Keywords: radiation therapy
a study of reduced dosing of the nonavalent hpv vaccine in women living with hiv

Conditions: HPV; Human Papilloma Virus; Human Immunodeficiency Virus

Summary: there are very little data on human papillomavirus (hpv) vaccination among the 18 million women living with hiv (wlwh) globally, who constitute a population most vulnerable to hpv and the resultant cervical cancer. particularly, there are no data to date on reduced-dose schedules of nonavalent hpv (9vhpv) vaccination in wlwh and there are very little data on the 9vhpv vaccine in this population overall. it is critical to examine the 9vhpv vaccine in wlwh now because the quadrivalent hpv (4vhpv) vaccine has been discontinued. additionally, in order to reach the world health organization's global goal of cervical cancer elimination, we must determine the role of various hpv prevention strategies in this important population including reduced vaccine dosing which can drastically increase the feasibility of hpv vaccination programs globally. this randomized clinical trial will enrol wlwh aged 18-45 from across canada who have not previously received an hpv vaccine. participants will be randomized 1:1 to receive 3 doses of 9vhpv vaccine at the routine vaccine schedule of 0/2/6 months or 2 doses at an expanded schedule of 0/6 months with a third dose at month 12 to adhere to current recommendations for wlwh. we will compare the immune response generated to two versus three doses of 9vhpv vaccine and will follow participants for 2 years to examine the immune response over time. this study, which builds upon our team's prior work on hpv vaccination in wlwh, will determine whether two doses of 9vhpv vaccine can be used in wlwh instead of three, and will examine additional aspects of hpv vaccination in wlwh including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected hpv samples in this population. these data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.


Eligibility criteria:
inclusion criteria: * living with hiv * has a uterine cervix exclusion criteria: * unable to give fully informed consent * pregnant or unwilling to avoid pregnancy during vaccination * allergy to the vaccine or its components * prior receipt of any hpv vaccine

Keywords: hpv vaccination
short-term effects of good metabolic control on cognitive function, wellbeing, and metabolic parameters in adult patients with phenylketonuria

Conditions: Phenylketonurias

Summary: the goal of this study is to evaluate if in adult patients with phenylketonuria (pku) without strict metabolic control during the last 12 months, strict metabolic control for 8 weeks results in an improvement of cognitive function.


Eligibility criteria:
inclusion criteria: * men and women with classical pku * age ≥ 18 years * good metabolic control during childhood (at least until 12 years of age) * plasma phe levels ≥ 15 mg/dl for ≥ 1 year * written informed consent prior to study participation exclusion criteria: * reduced cognitive function (unability to perform test battery) * drug and or alcohol abuse * treatment with bh4 * treatment with drugs known to affect cognitive function

Keywords: cognitive function adults
controlled sedation for cataract surgery

Conditions: Failed Conscious Sedation During Procedure

Summary: this study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation

this is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. the surgery was done under local anesthesia and sedation.

Eligibility criteria:
inclusion criteria: * subject has cataract, * subject older than 18 years, * local anesthesia and sedation. exclusion criteria: * general anesthesia, * history of consumption of sedatives.

Keywords: sedation dexmedetomidine remifentanil cataract surgery surgeon satisfaction patient satisfaction
reduce sedentary behavior during cancer treatment - the redsedcan study

Conditions: Breast Cancer; Colorectal Cancer (CRC); Prostate Cancer; Neoadjuvant Therapy; Adjuvant Therapy

Summary: summary reducing sedentary behavior during treatment is important to reduce the risk of future health problems in individuals undergoing cancer treatment. therefore, the goal of this project is with a multicenter randomised controlled design investigate whether a digital self-management program during ongoing neo- or adjuvant cancer treatment for breast, prostate or colon cancer is effective in reducing sedentary lifestyle and improving well-being in the short and long term.

description of the project this project is about investigating the effect of a digital self-management program to reduce sedentary behavior in people with breast, prostate, or colorectal cancer during neo- or adjuvant cancer treatment. the self-management program has been developed with patients and researchers and consists of existing high-quality technology that provides support for setting and following goals. the people who use the self-help program also receive support from a physiotherapist to set goals for reduced sedentary time and get to choose which activities will replace the time spent sedentary. the goal of the project the goal of the project is to investigate the effects of a digital self-management program on reduced sedentary and well-being during ongoing cancer treatment, both in the short and long term. in addition, the project will study the health-economic effects, and climate benefits of using the digital self-management program. by focusing on reducing a sedentary lifestyle and replacing it with daily activities and/or physical activity, the health of individuals is expected to be positively affected in the short term through, for example, increased well-being and reduced side effects from cancer treatment, and the long term through a reduced risk of developing complications and new illness related to the cancer treatment, such as cardiovascular disease.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with breast, prostate, or colorectal cancer planned for or resently started neo- or adjuvant treatment (e.g. chemotherapy, radiotherapy, endocrine treatment) at the hospitals in uppsala and västerås, sweden. exclusion criteria: * individuals diagnosed with dementia. * individuals diagnosed with severe psychiatric disease. * individuals with severe loss of vision, or communicative ability. * individuals who cannot walk independently indoors with or without a walking aid. * individuals completed treatment for other cancer diseases less than 12 months ago or not recovered from previous cancer treatment.

Keywords: sedentary behavior behavior change intervention randomized controlled trial
stroke card long-term follow-up

Conditions: Ischemic Stroke; TIA

Summary: we undertook the stroke-card trial (nct02156778) between 2014 and 2018 with follow-up until 2019 to evaluate the efficacy of the post-stroke disease-management program stroke-card care. to further investigate the long-term efficacy of stroke-card care all participants of the original trial will be invited for a long-term in person follow-up (3 - 6 years).


Eligibility criteria:
inclusion criteria: * inclusion in the previous stroke-card trial (nct02156778) * written informed consent exclusion criteria: * none

Keywords: ischemic stroke secondary prevention transient ischemic attack disease management