Kornimate/medical-research-clean huggingface dataset:
ulipristal emergency contraception used before or after ovulation

Conditions: Contraception

Summary: this was a prospective, open-label, single-drug, uncontrolled, observational clinical study. women attending the family planning association of hong kong (fpahk) for emergency contraception within 120 hours of upsi were recruited. subjects were recruited from both the birth control clinics and youth health care centres of the fpahk. depending on the timing in relation to ovulation in the current menstrual cycle at the time of presentation, the women were classified into two groups: group 1: pre-ovulatory group 2: post-ovulatory after counseling and obtaining informed consent, eligible subjects received a single dose of ulipristal acetate 30 mg (ellaone®) under direct supervision. a baseline blood test for hormonal profile (lh, oestradiol and progesterone) and ultrasound scan for ovarian follicle assessment were carried out by a designated doctor or research nurse at the clinic visit. the subjects were advised not to have further acts of coitus before the return of menstruation. they were given a diary chart to record vaginal spotting and bleeding, possible side effects and further acts of intercourse, if any, and the contraceptive method used. a follow-up appointment were be arranged about 1-2 weeks after the expected next menstruation. any events of unplanned pregnancy and adverse effects were recorded for analysis.


Eligibility criteria:
inclusion criteria: 1. healthy women aged 18 years or above; 2. regular menstrual cycles (every 21-35 days) within the past three cycles; 3. requesting emergency contraception within 120 h of a single act of unprotected intercourse in the current menstrual cycle; 4. willing to abstain from further acts of unprotected intercourse and; 5. available for follow-up over the next 6 weeks exclusion criteria: 1. post-abortion or postpartum patients whose period had not yet returned 2. regular use of prescription drugs before admission to the study and 3. intercourse during the treatment cycle more than 120 h before admission into the study. 4. found pregnant at the time of presentation 5. breastfeeding women 6. women who have been sterilized (or partner being sterilized) or have intrauterine contraceptive device in-situ 7. uncertain about the date of the last menstrual period 8. women who had used hormonal contraceptive in the current or past one cycle

Keywords: emergency contraception ulipristal acetate efficacy
novel rinse to treat in oral candidiasis in cancer patients

Conditions: Candidiasis, Oral; Thrush; Candidiasis

Summary: the purpose of the study is to evaluate the efficacy of iocide oral rinse as a treatment for oral candidiasis in any patient including but not limited to patients receiving radiation therapy or who have previously received radiation therapy for head and neck cancer, or patients positive for hiv/aids or are transplant patients.

a four-week study has been designed as an assessment of the clinical cure and mycological eradication of oral candida isolates in 40 cancer patients referred by radiation oncologists during the course of his/her treatment. an estimated 35 patients will be evaluable at the end of the study. candida infection is defined as positive clinical signs (white plaques) with positive potassium hydroxide (koh) preparation and positive cultures. colonization is defined as a positive culture without signs of clinical infection.

Eligibility criteria:
inclusion criteria: * males or non-pregnant females currently receiving or post radiation therapy for head and neck cancer; * 18 years of age; * with signs and symptoms of oral candidiasis as determined by investigator(s); * females using an effective contraception method during study. * patients must be able and willing to comply with study requirements, and have full understanding of all elements of, and signature and dating of, informed consent prior to initiation of protocol specified procedures. * participating female subjects must agree to use adequate contraceptive measures during the trial. before entering the study, women of childbearing age will be tested for pregnancy with a urine pregnancy test. exclusion criteria: * history, or current evidence, of any significant acute or chronic medical or psychiatric condition that would render examination difficult or invalid or prevent the subject from active study participation; * inability to use an oral rinse; * use of concomitant medication that, in the opinion of the study director, might interfere with the outcome of the study (e.g. anabolic steroids or excessive corticosteroids, large doses of aspirin (no more than one 325 mg tablet per day), phenytoin, lithium, coumadin or iodine containing preparations \[use of iodized table salt is acceptable\]). steroids, therapeutic doses of non-steroidal anti-inflammatory agents, estrogen therapy agents and oral contraceptives are ok to use as long as the baseline dose remains steady through the end of the study; * use of antifungal medication in the last 30 days, purported sensitivity or allergy to iodine; * pregnant or nursing patients as the effect of iocide in the fetus or infant are not established; * history thyroid disease.

Keywords: candidiasis, oral thrush candidiasis
effect of intravenous intralipidtherapyon pregnancy outcome in women with history of recurrent implantation failure undergoing intracytoplasmic sperm injection-embryo transfer cycle: a randomized controlled trial

Conditions: Infertility Due to Nonimplantation

Summary: to evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (rif) undergointracytoplasmic sperm injection (icsi).

the aim to evaluate the effect ofempiricintralipidinfusion therapy on pregnancy outcomes in patient withunexplained recurrentimplantation failure (rif) undergointracytoplasmic sperm injection (icsi). a total of 142 patients with history of unexplained rif3 or more cycles were included in the study. patient were randomized into two groups, study group (n=71) and control group (n=71). the study groupreceivedintralipid 20%infusionon the day of embryo transfer (et) and a second dose on the day of pregnancy test. the control group underwent et without intralipidinfusion.allpatientswereclosely monitored for any side effectsincluding allergic reactions.

Eligibility criteria:
inclusion criteria: * age \< 42 years * bmi \< 30 kg/m2 * history of 3 or more recurrent implantation failure undergoing intracytoplasmic sperm injection (icsi ) cycle. exclusion criteria * women with medical contraindications of intralipidinfusion. * uterine fibroid. * endometrial polyp. * endometriosis,hydrosalpinx. * intrauterine adhesion and uterine anomalies. * women with positive thrombophilia screen. * diminished ovarian reserve. * severe male factor infertility . * chronic medical illnesses which may contribute in impaired chance of pregnancy .

Keywords: infertility , implantion failure, intracytoplasmic sperm injection
average volume-assured pressure support as rescue therapy in obesity hypoventilation syndrome

Conditions: Obesity Hypoventilation Syndrome (OHS)

Summary: it remains unclear whether cpap therapy should be prescribed if significant hypoxemia persists during cpap titration, despite optimization of upper airway obstructive events, if maximum cpap pressure is reached. the goal was to examine the effects of 6 months of home avaps therapy in patients with obesity hypoventilation syndrome as a potential option for patients who failed cpap titration due to persistent hypoxemia.

obesity hypoventilation syndrome (ohs) is one of the leading indications of home non-invasive ventilation (niv) initiation. in patients with ohs, niv improves daytime vigilance, decreases paco2, improves sleep quality, and improves physical activity. thus, the primary aim of this study was to evaluate the effects of 6-month noninvasive ventilation with average volume-assured pressure support (avaps-ae) ventilation on objective sleep quality and adherence to therapy in stable patients with ohs who failed cpap titration.

Eligibility criteria:
inclusion criteria: * all clinically stable ohs patients with * body mass index of 30 kg/m2 , * daytime hypercapnia (paco2 \&gt;45 mm hg) who had failed to respond to cpap therapy * had no other cause for their chronic respiratory failure and were naive to any pap therapy. exclusion criteria: * patients with evidence of acute respiratory failure (patients with worsening symptoms during the last 2 weeks before the screening visit, a breathing frequency of 30 breaths/ minute, or signs of respiratory infections) * patients who had been intubated during the last 3 months * patients who had received any other form of ventilatory support before hospital admission were also excluded from the study

Keywords: ventilation, obesity
a phase 3 study of ni-071 in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to investigate similarity between ni-071 and infliximab(the comparator) in terms of efficacy in patients with rheumatoid arthritis not adequately responding to methotrexate.


Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of ra as defined by the american college rheumatology (acr) and european league against rheumatism (eular) criteria (acr/eular 2010) 2. patients who received mtx treatment (6- 16mg/week) for 2 weeks for at least 12 weeks prior to the screening visit exclusion criteria: 1. patients with a following past history or concomitant diseases * other connective tissue disorders which may interfere the efficacy assessment * chronic or recurrent infectious disease * demyelinating disease * congestive heart failure * lymphoproliferative disorder or myelodysplastic syndrome * malignancy * interstitial lung disease 2. patients with active or latent tuberculosis or history of tuberculosis
dose response study of dexamethasone in combination with bupivacaine 0.25%

Conditions: Post Surgical Pain

Summary: when used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (sbp) in arthroscopic shoulder surgery. this study seeks to determine if there is a relationship between the duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (sbp) when combined with increasing doses of dexamethasone.

the exact mechanism of dexamethasone on peripheral nerve block is unclear. the current theory is that the effect is not dose related, while only 4mg and 8mg doses were studied. our hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect on the duration of analgesia. therefore, we are not considering any patients to receive suboptimal dosing of preservative free dexamethasone in this study.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already elected to receive and are eligible for regional anesthesia (brachial plexus nerve block) prior to consenting for study. 2. ability to sign informed consent. 3. ability to follow study protocol, and speak, read and write in english. 4. must have valid phone number for follow-up purpose. 5. must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet. exclusion criteria: 1. patient younger than 18 years old and older than age 70 2. patient refusal to sign consent 3. chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record 4. allergy to any of the protocol medications 5. patients with severe lung disease, contra lateral phrenic nerve injury, insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as documented in patient's medical record 6. pregnancy (positive urine pregnancy test result in preop area on morning of surgery)
dose range finding study to assess efficacy and safety of tozorakimab in adults with uncontrolled asthma on medium-to-high dose inhaled corticosteroids

Conditions: Asthma

Summary: this is a dose-range finding, double-blind, placebo-controlled, phase iib study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated written informed consent prior to any study-specific procedures. 2. adults aged 18-75, inclusive when signing the informed consent. 3. documented physician-diagnosis of asthma for at least 12 months. 4. treated with medium or high dose ics in combination with laba. 5. demonstration of uncontrolled asthma through acq-6 score ≥ 1.5 . 6. pre-bronchodilator fev1 ≥ 40% to ≤ 90% of predicted normal. 7. documented exacerbation history in the last 12 months and biomarker requirements of: 1. 2 severe exacerbations or 2. 1 severe exacerbation and: (i) eosinophils ≥ 150 cells/µl or (ii) feno ≥ 25 ppb 8. participants need to demonstrate a ≥70% compliance for asthma daily diary. 9. women of child bearing potential (wocbp) must have a negative pregnancy test. 10. contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. exclusion criteria: 1. completed treatment for respiratory infection with antibiotics in the 4 weeks prior to visit 1. 2. clinically significant pulmonary disease other than asthma . 3. current smokers, former smokers with \>10 pack-years history. 4. clinically significant aortic stenosis or pulmonary arterial hypertension. 5. active tuberculosis, hepatitis, hiv, or current diagnosis of cancer or immune complex disease. 6. unstable cardiovascular disorders.
an early safety and efficacy study of ascites management: standard paracentesis or early intervention with pleurx catheters in patients with malignant ascites

Conditions: Malignant Ascites

Summary: the purpose of this study is to assess in a controlled prospective setting, the safety of the use of pleurx catheters and standard therapeutic paracentesis in patients with malignant ascites.

study design: single institution, open-label, randomized study study device: pleurx catheter treatment plan: cohort a: 15 patients treated with standard therapy (therapeutic paracentesis +/- diuretics) cohort b: 15 patients treated with peritoneal pleurx catheter duration of participation: patients will be followed for one year, or until death, whichever comes first. primary outcome: safety of the pleurx catheter procedure or paracentesis secondary outcomes: overall complications, quality of life, overall survival, and symptom control

Eligibility criteria:
inclusion criteria: (patients can receive chemotherapy at the discretion of treating oncologist) 1. patients with recurrent malignant ascites 2. patients with refractory malignant ascites 3. proven malignancy 4. age \>= 18 years old 5. eastern cooperative oncology group (ecog) performance scale =\< 2 6. ability to understand and willingness to sign a written informed consent definitions: malignant ascites: one of the following criteria 1. positive ascitic fluid cytology 2. histology proven malignancy with imaging studies with evidence of liver metastasis and ascites 3. malignant budd chiari syndrome with associated ascites 4. hepatocellular carcinoma and ascites 5. chylous ascites due to lymphoma 6. peritoneal carcinomatosis and concurrent ascites 7. proven abdominal malignancy with concurrent ascites refractory / recurrent ascites: one of the following criteria 1. symptomatic ascites that recurred after one paracentesis in a patient with known malignant ascites. 2. symptomatic ascites that did not respond clinically to at least two weeks of diuretics. use of diuretics at the discretion of the treating physician. 3. intolerance or relative contraindications to diuretics: (serum sodium (na) concentration of \ 1.5 mg/dl, hyperkalemia (potassium \>5.2 meq/l or azotemia bun/creatinine ratio \> 20). 4. removal of at least 5 l in the preceding two months for symptoms relief exclusion criteria: 1. life expectancy less than one month 2. coagulopathy (international normalized ratio \[inr\] \> 2 that does not correct with fresh frozen plasma) 3. hepatorenal syndrome 4. active skin infections at abdomen before procedures 5. inability to provide inform consent 6. platelet counts \< 50,000/mcl 7. uncontrolled illness including, but not limited to, ongoing or active infection requiring intravenous (iv) antibiotics, that the physician feels would increase the risk of infection with the procedures or white blood cell (wbc) count \> 20,000/mcl 8. absolute neutrophil count \<1000 / cu mm 9. pregnant women 10. multiloculated ascites

Keywords: pleurx catheter malignant ascites
gene therapy to improve wound healing in patients with diabetes

Conditions: Wounds and Injuries; Diabetes; Diabetic Foot Ulcers; Foot Wounds

Summary: patients with diabetes may develop chronic wounds that respond poorly to treatment. gene therapy with the platelet-derived growth factor-b gene has been shown to help with the healing of chronic wounds. this study will evaluate a new way to deliver the gene to the wound tissue.

chronic wounds, such as diabetic ulcers, pressure ulcers, and venous stasis ulcers, cause significant morbidity in millions of patients each year in the united states. individuals with long-standing diabetes develop both peripheral vascular disease and peripheral neuropathy. these patients may not feel pressure from shoes or objects which can damage their skin. once a wound is formed, it may heal very slowly or not at all due to diabetic complications. platelet-derived growth factor-b (pdgf-b) has been approved for use in diabetic ulcers. however, delivery and maintenance of the drug at the wound site in sufficient quantities for a sufficient period of time is a major hurdle to widespread use. gene activated matrix (gam) technology offers the opportunity to place a therapeutic gene contained within a structural matrix into a wound site. this study will evaluate the safety and potential clinical utility of topical applications of gam501, a gene for pdgf-b contained within an e1-deleted adenoviral vector and formulated in a bovine type i collagen gel. this formulation allows for the migration of wound repair cells into the structural matrix, where they encounter the viral vector and subsequently produce the therapeutic protein within the local wound environment. participants in this study will receive up to four treatments with gam501. participants will be followed by multiple observations over a 6 to 7 month period.

Eligibility criteria:
inclusion criteria * adequately controlled diabetes mellitus (type i or ii) as defined by hba1c \< 10.0% * cutaneous, lower extremity, plantar medial or lateral surface ulcer between 1 and 10 cm2 post-debridement * ulcer present for \> 6 weeks prior to study entry * ulcer free of all necrotic and infected soft tissue * affected limb transcutaneous oxygen pressure (tcpo2) \> 30 mmhg at screening or a palpable dorsal pedal or posterior tibial pulse * inability to perceive 10 grams pressure using a semmes-weinstein 5.07 monofilament in the peri-ulcer area

Keywords: gene transfer adenovirus platelet-derived growth factor-b collagen diabetic ulcer foot wounds diabetic ulcers
vivexx carotid revascularization trial (viva)

Conditions: Carotid Artery Stenosis

Summary: to evaluate the safety and efficacy of the bard vivexx carotid stent and emboshield barewire rapid exchange embolic protection system in the treatment of extracranial carotid artery stenosis in patients at high risk for carotid endarterectomy.

patients with clinically significant stenosis within the common and/or internal carotid artery who are at high risk for carotid endarterectomy and are amenable to percutaneous treatment including embolic protection, balloon angioplasty and the carotid stent placement.

Eligibility criteria:
inclusion criteria: * the patient has a symptomatic or asymptomatic carotid artery stenosis that meets one of the following criteria: * symptomatic: \> than or = to 50% carotid stenosis by angiography and a history of non-disabling stroke, transient ischemic attack (tia) in the hemisphere supplied by the target vessel within 180 days of the procedure. * asymptomatic: \> than or = to 80% carotid stenosis by angiography without neurological symptoms. * high risk for carotid endarterectomy: anatomical and co-morbid. exclusion criteria: * history of symptoms of stroke or tia within 24 hours of the procedure * extensive or diffuse atherosclerotic disease * severe vascular tortuosity or anatomy that would preclude the safe introduction of the device

Keywords: carotid artery stenosis
a study to evaluate the adverse events, and efficacy of intravenous (iv) of telisotuzumab adizutecan in combination with iv oxaliplatin, fluorouracil, folinic acid/leucovorin, bevacizumab, panitumumab in adult participants with metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: crc is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. the purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5fu), leucovorin (lv) (folfox), and bevacizumab or panitumumab. telisotuzumab adizutecan is an investigational drug being developed for the treatment of mcrc. fluorouracil and leucovorin are drugs approved for the treatment of mcrc. this study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with folfox and bevacizumab or 5fu/lv and panitumumab until the dose reached is tolerable and expected to be efficacious. participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with folfox and bevacizumab or 5fu/lv and panitumumab, or a comparator of folfox and bevacizumab or panitumumab. approximately 390 adult participants with mcrc will be enrolled in the study in 100 sites worldwide. in the dose escalation stage participants will be treated with increasing intravenous (iv) doses of telisotuzumab adizutecan with folfox and bevacizumab or 5fu/lv and panitumumab until the dose reached is tolerable and expected to be efficacious. in the dose optimization stage participants will be receive folfox or receive 5fu/lv, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of folfox and bevacizumab/pantitumumab. the study will run for a duration of approximately 6 years. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the study at an approved institution (hospital or clinic). the effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1. * laboratory values meeting the criteria within the protocol. * has measurable disease per response evaluation criteria in solid tumors (recist) v1.1. exclusion criteria: * prior systemic regimen containing c-met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and/or any topoisomerase inhibitor(s) (e.g., irinotecan). * history of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.

Keywords: metastatic colorectal cancer andrometa-crc-533 telisotuzumab adizutecan