Kornimate/medical-research-clean huggingface dataset:
a phase 1/2 study evaluating abt-751 in combination with alimta in advanced non-small cell lung cancer

Conditions: Lung Cancer; NSCLC; Non-Small-Cell Lung Cancer

Summary: to determine the efficacy of abt-751 when administered in combination with standard pemetrexed in subjects with advanced or metastatic nsclc. the phase 1 portion of the study is complete and the study is currently enrolling subjects in phase 2.


Eligibility criteria:
inclusion criteria: * pathologically documented nsclc * locally advanced (stage iii) or metastatic (stage iv) nsclc * only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy) * only one prior anti-tumor treatment regimen in the curative setting * progressive disease following the previous anti-tumor treatment regimen * measurable disease by recist criteria * brain metastasis must be stable and well-controlled * ecog performance score 0-2 * all anti-tumor therapy discontinued at least 3 weeks prior to study entry * all adverse events from prior treatment are resolved or stable * adequate hematologic, renal, and hepatic function * females must not be pregnant * willing to take adequate measures to prevent pregnancy * life expectancy of at least 3 months * able to complete the quality of life questionnaire * voluntarily signed informed consent exclusion criteria: * greater than grade 1 neurological findings * allergy to sulfa medications * previous treatment with abt-751 or pemetrexed * receipt of more than one investigational agent for nsclc * significant weight loss (\>10%) within 6 weeks of study entry * glucose-6-phosphate dehydrogenase deficiency or porphyria * significant systemic disease that would adversely affect participation * class 3-4 new york heart association classification status * other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator

Keywords: lung cancer abt-751 nsclc alimta non-small-cell lung cancer pemetrexed
the economic burden of chronic obstructive pulmonary disease(copd) in south korea

Conditions: COPD; Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to estimate a direct/indirect medical cost and to provide evidence establishing efficient strategies to reduce medical costs of copd in korea.

this study is a multi-center research on economic burdens of copd for a year. it is composed of three phases detailed as follow. phase 1: direct cost estimation in copd patients (n = 400) direct cost determined as amount of money expended to medical institutes for treatment. estimated costs, based on the information from health insurance review agency(hira) and the national health and nutrition examination survey (nhanes) data, are collected. phase 2: indirect cost estimation by sampling survey in copd patient indirect cost is extra-expanses excluding hospital fees, including cost for transportation, medical instruments, home care services and loss of labor capacity reduction. the information was collected by structured questionnaire for 12 weeks. phase 3: direct/indirect cost is validated and analyzed based on the collected information from phase 1 and 2 according to severity defined by the gold guideline.

Eligibility criteria:
inclusion criteria: * over 20 years old * copd patients exclusion criteria: * patients who disagree with participating in research
clinical trial of clarithromycin, lenalidomide and dexamethasone in the treatment of the first relapsed multiple myeloma

Conditions: Multiple Myeloma in Relapse

Summary: bird regimen consisting of clarithromycin and rd is safe and effective in ndmm. it can significantly increase orr (up to 90.3%) , relief depth (≥vgpr), and prolong pfs to 43 months. in our previous study, thirty rrmm patients treated with bird regimen in 6 centers in china benefited.it suggested that bird regimen may not only improve overall efficacy of rrmm , especially long-term benefits, but also reverse rd resistance in patients who fail to achieve any remission after multiline therapy.the study is a prospective, multicenter, single arm, phase ii clinical trial, which intend to recruit first relapse mm patients over 18 years old. once included, patients will receive the treatment of clarithromycin lenalidomide dexamethasone (bird) regimen. (clarithromycin 500mg，po，bid，d1-21; lenalidomide 25mg，po，daily，d1-21 (dose according to creatinine clearance rate); dexamethasone 20mg，po，daily，d1-2, 8-9,15-16, 22-23) and we will evaluate efficacy and adverse events of the bird regimen at a point of time predetermined.


Eligibility criteria:
inclusion criteria: 1. diagnosed as symptomatic multiple myeloma. 2. the first relapse/progression with thalidomide, bortezomib or lenalidomide based current first-line treatment or resistance to the first-line treatment (previous treatment line number =1). 3. there must be measurable lesions to determine disease progression (pd): according to the imwg 2016 efficacy evaluation criteria. 4. the expected survival time is longer than 3 months. 5. ecog score less than 2 points. 6. the serum ast/alt level \<3 times higher than the normal value; the serum total bilirubin level\<2 times of the normal value; creatinine clearance rate was ≥30ml/mi. 7. neutrophil count \>1000/mm3 ; platelet count \>75000/mm3 (if bone marrow plasma cell \ 30000/mm3 (if the plasma cells in the bone marrow is not less than 50%). 8. women of childbearing age were negative for pregnancy before admission, and agreed to carry out pregnancy screening during the study (once a month until 4 weeks after the last dose), and agreed to use contraceptive measures within 3 months after the study and the last dose. 9. all patients were required to sign informed consent. exclusion criteria: 1. under the age of 18 2. ecog score \>2 3. non secretory myeloma, defined as serum protein m \< 1g/dl, urinary m protein \< 200mg/24h and sflcr ≤100mg/l 4. there is growing demand, pregnant or lactating women within one year 5. hiv infection 6. activity of hbv or hcv infection 7. 4 weeks before entering the group of thromboembolic events 8. not signed informed consent

Keywords: clarithromycin lenalidomide dexamethasone regimen treatment response survival
clinical study for palliative/preventive treatment of chronic back pain

Conditions: Supplementation; Back Pain

Summary: randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a botanical supplement on the prevention of non-joint pain.

subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned). the product to be consumed is a botanical extract. participants will consume the product for 84 days. it should be taken half an hour before breakfast, two capsules per day. the study subjects will have to make 5 visits to the laboratory. on the first and last visit, they will have their blood drawn, their sleep quality will be evaluated and they will complete a series of questionnaires to evaluate their quality of life and type of back pain. in the rest of the visits they will only have to take the tests on paper.

Eligibility criteria:
inclusion criteria: * men and women between 20 and 65 years of age. * the subjects must have localized myofascial pain in the back area (cervical, dorsal and lumbar), with an evolution time of at least 3 months. * the pain must present an initial score of at least 30 mm in the pain evaluation by means of the vas scale. * the pain must be episodic. * bmi 18.5 - 29.9 kg/m2. * subjects should not be treated with narcotic drugs or steroidal anti-inflammatory drugs. steroidal anti-inflammatory drugs or immunosuppressants. exclusion criteria: * severe or terminal illnesses. * subjects with pain associated with trauma. * subjects with pain associated with chronic conditions (rheumatoid arthritis, herniated discs, ankylosing herniated disc, ankylosing spondylitis, etc.). * subjects with known allergy to any of the components of the investigational product. the investigational product. * subjects undergoing physiotherapy treatment during the course of the study. development of the study. * pregnant or lactating women. * inability to understand the informed consent.

Keywords: botanical extracts
nail bed repair with or without nail bed coverage

Conditions: Infection; Laceration Repair; Laceration Repair, Children; Nail Bed Injury

Summary: a randomized clinical trial conducted at patel hospital, karachi, from march 2024 to february 2025, to evaluate infection in patients undergoing nailbed repair with and without nailbed coverage, with minimum follow up for one month post operative.

background: the fingernail serves as a protective barrier for the dorsal fingertip while also enhancing its aesthetic appeal. fingertip injuries account for approximately two-thirds of pediatric hand injuries, with nail bed injuries comprising 15% to 24% of these cases. in the united kingdom, 96% of surgeons routinely remove the nail plate, repair the nail bed, and reposition the nail plate onto the nail bed. the rationale for repositioning includes protecting the repair, reducing infection risk, minimizing pain during dressing changes, and preventing adhesions by supporting the nail fold. when the autologous nail is unavailable, alternatives such as silver foil is used. objective: this study aims to evaluate the risk of surgical site infection after nail bed repair with and without nail bed coverage. methods: this is a two-arm randomized clinical trial enrolling 152 patients (76 in each group) over a 12-month period from march 2024 to february 2025. patients undergoing nail bed repair will be randomized into two groups-one receiving nail bed coverage (repositioned nail or substitute) and the other without coverage. the primary outcome is the incidence of surgical site infection. secondary outcomes include pain during dressing changes and cosmetic results.

Eligibility criteria:
inclusion criteria: * patients of all age groups and genders, * presented to the emergency or outpatient department within 48 hours of injury, * provided written informed consent (or had consent given by a parent/guardian in the case of minors), * injury to a single finger, * fractures that do not involve an open wound or require fixation. exclusion criteria: * infected injuries, * underlying nail diseases, * pre-existing deformities in the injured or contralateral finger, * distal phalanx fractures requiring fixation, * amputations, * partial or complete loss of the nail bed requiring reconstruction, * multiple nail bed injuries, * known allergies to prescribed postoperative medications.

Keywords: nail bed repair nail bed coverage infection after nail bed repair fingertip laceration pediatric nail bed injury randomized clinical trial
lifestyle intervention for toddlers pilot study

Conditions: Obesity

Summary: study aims to pilot a family-centred tailored nutrition intervention at child welfare clinics, targeting the previously observed dietary defaults of finnish children.

eating habits can predict diet-related health problems and obesity. the defaults observed previously in the diet of finnish children include low consumption of vegetables, fruits and vegetable oil-based fats, high consumption of sucrose, poor quality of drinks and low frequency of family meals. child welfare clinic is the place to promote healthy lifestyles because most finnish families visit there at regular intervals.

Eligibility criteria:
inclusion criteria: * all families at their child's standard 6-month child welfare clinic visit exclusion criteria: * families with twins * families who do not speak finnish
expanded access for the treatment of advanced cholangiocarcinoma with abc294640 (yeliva ®)

Conditions: Cholangiocarcinoma; Cholangiocarcinoma Non-resectable; Cholangiocarcinoma, Perihilar; Cholangiocarcinoma, Extrahepatic; Cholangiocarcinoma, Intrahepatic

Summary: this is an expanded access program (eap) for eligible participants who do not qualify for participation in, or who are otherwise unable to access, the ongoing clinical trial abc-108. this program is designed to provide access to abc294640 (yeliva ®) for treatment of cholangiocarcinoma (cca) prior to approval by the local regulatory agency. availability will depend on territory eligibility. participating sites will be added as they apply for and are approved for the eap. an oncologist must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility criteria:
inclusion criteria: 1. diagnosis of cholangiocarcinoma 2. ineligible to participate in the abc294640 clinical trial for the treatment of cholangiocarcinoma or geographically inaccessible to the trial. 3. judged by the treating oncologist to be medically suitable for treatment with abc294640 4. willing and able to provide written, signed informed consent 5. approval by redhill of the treating oncologist's clinical trial experience for the purpose of making abc294640 available 6. regulatory approval by the appropriate jurisdiction exclusion criteria: 1. any medical condition that may cause treatment with abc294640 to be potentially harmful as judged by redhill

Keywords: clinical trial, phase ii multicenter trials clinical study clinical trials, non-randomized oral capsule single arm anti-cancer anti-inflammatory abc294640 expanded access program compassionate use special access program yeliva ® opaganib
the role of transcutaneous electrical nerve stimulation (tens) for menstrual pain relief

Conditions: Primary Dysmenorrhea

Summary: the present study aims to verify the analgesic potential of a transcutaneous electrical nerve stimulation (tens) device using patients with primary dysmenorrhea and compare it with a control period without usage.


Eligibility criteria:
inclusion criteria: * history of lower abdominal pain (dysmenorrhea) for more than 6 consecutive menstrual cycles with a moderate or severe pain rating ≥5 out of 10 over course of last year * bmi of 18.5-29.9 as a bmi below or above these cut points results in highly varied menstrual cycle lengths * not taking contraception or other types of medication that could influence reproductive status * regular menstruation * medically free from chronic diseases * free from known gynecological problems (ie. endometriosis, fibroids, ovarian cysts) * history of analgesic pill intake during menstruation * no pelvic pathology exclusion criteria: * amenorrhea * on a form of contraception * secondary dysmenorrhea and/or other gynecological problems that may cause pain * no discomfort, pain, or other symptoms during menstruation * history of surgery over lower abdomen area * allergy to ibuprofen * cardiac disability * pacemaker * arterial disease * uncontrolled hemorrhage * blood clots * pregnancy or trying to become pregnant * cancerous lesions * exposed metal implants * history of seizures * sensory or mental impairment * unstable fractures
prospective study of the diagnostic and therapeutic management of congenital glaucoma in france

Conditions: Congenital Glaucoma

Summary: evidence of a relationship between age at discovery of congenital glaucoma and visual acuity at 4 years of age. the delay in diagnosis is a factor of poor visual acuity. will justify the implementation of information programs with health and education professionals in order to improve the functional prognosis of patients with congenital glaucoma.

prospective multicentre prospective cohort enabling the identification and follow-up of an almost exhaustive population of incidents of congenital glaucoma in 23 ophthalmology centers in france inclusion over 4 years epidemiological data, all reports of consultation, medical and surgical procedures collected in an e-crf. database for gene research related to congenital glaucoma to provide screening, genetic counseling and personalized care

Eligibility criteria:
inclusion criteria: * boys or girls under the age of 4, without antecedent, french or resident in france, suspected glaucoma exclusion criteria: * antecedent of surgery for glaucoma

Keywords: visual acuity prognosis epidemiology
assessment of diabetic maculopathy changes after phacoemulsification by using optical coherence tomography

Conditions: Maculopathy

Summary: investigators aimed to assess the macular changes with oct after uncomplicated phacoemulsification surgery in diabetic patients with non proliferative diabetic retinopathy (npdr) at the time of surgery and the effect of perioperative and postoperative topical nsaids on macular changes .

diabetic patients pose a particular challenge because of the tendency for early formation of cataract in them and propensity to develop macular edema after cataract surgery. macular edema (me) is a major cause of vision loss after cataract surgery in patients with diabetes . macular edema is a common cause of unfavorable visual outcome after cataract surgery. clinically significant cystoid macular edema (csme) has a reported incidence of 1% to 2% after cataract surgery. diabetes has been associated with an increased incidence of postoperative macular edema. the incidence of macular edema on optical coherence tomography (oct) was 22% in diabetic eyes undergoing cataract surgery. the macular edema after cataract surgery in diabetic patients could be caused by the cataract surgery or diabetes itself, but it might be hard to differentiate between these two causes . the level of the preexisting diabetic retinopathy (dr), the presence of clinically significant macular edema (csme) before the surgery, and duration and regulation of diabetes are all important indicators of postoperative cme . optical coherence tomography (oct) has been established as a practical method for examining retinal architecture. oct, with its noninvasive nature, has been proven to be an indispensable tool for diagnosing retinal pathologies, including cystoid macular edema (cme). many studies have reported incidences of cme and macular thickness changes, determined by oct following uneventful cataract surgeries .nonsteroidal anti-inflammatory drugs (nsaids) are widely used and studied by cataract surgeons for varied benefits in the perioperative and postoperative period. nonsteroidal anti-inflammatory drugs (nsaids), a class of medications that inhibit cyclooxygenase (cox) enzymes from producing pro-inflammatory prostaglandins, have multiple indications in the perioperative period including pain control, reducing inflammation, improving intraocular mydriasis, and preventing postoperative cystoid macular edema (cme) .cataract surgeons often use nsaids postoperatively to control patient pain, inflammation, and prevent cme, the most prevalent complication affecting postoperative visual recovery .

Eligibility criteria:
inclusion criteria: controlled type 2 non proliferative diabetic retinopathy (npdr) patients. immature cataract which does not interfere with ocular imaging. exclusion criteria: * patient with dense cataract or vitreous hemorrhage interfering with measurement of central macular thickness chronic uveitis any posterior segment pathology that could affect retinal thickness patient with complicated cataract surgery.
rhizarthrosis surgery and functional recovery: arthroplasty vs. trapezectomy

Conditions: Rhizarthrosis

Summary: rhizarthrosis is a form of osteoarthritis that affects the trapeziometacarpal joint at the base of the thumb, which is more common in women over 50. genetic and hormonal factors as well as the frequency of certain physical movements may contribute to its appearance. surgical treatment is recommended if medical treatment fails, and trapezectomy is currently considered the standard method, although 3rd generation trapeziometacarpal prostheses are also available. the aim of this study is to compare the clinical and radiographic results after surgical treatment of rhizarthrosis: prosthesis versus trapezectomy.

this is a two-center, randomized, prospective, comparative study. the functional, clinical and radiographic evaluation in the early, medium and long term will make it possible to determine the possible superiority of arthroplasty if it exists. the close evaluation of the patients during the first 3 months will make it possible to update the superiority of the arthroplasty on the functional recovery in the short term if it exists.

Eligibility criteria:
inclusion criteria: 1. age \>45 years 2. symptomatic trapezius-metacarpal osteoarthritis after failure of medical treatment ( night orthosis 3 months + failure of 2 infiltrations/year) 3. patient who has given his/her consent to participate in the study after being informed by the surgeon, 4. patient living in france and able to answer the survey alone. 5. subject affiliated to a social security system or beneficiary of such a system 6. no participation in any other clinical study exclusion criteria: 1. minor patient 2. trapezium height \< 8 mm 3. major subject protected by law, under curatorship or guardianship 4. known allergy to the materials of the medical device 5. local infection 6. local skin necrosis or unhealed wound 7. pregnant or nursing women

Keywords: osteoarthritis - trapezectomy
effect of ramadan fasting on ovulation and insuline resistance in patients with pcos

Conditions: Polycystic Ovary Syndrome

Summary: polycystic ovary syndrome (pcos) has a heterogeneous clinical presentation comprising reproductive (hyperandrogenism, menstrual irregularity, anovulation, infertility, pregnancy complications), metabolic \[insulin resistance (ir), increased type 2 diabetes mellitus (t2dm) and cardiovascular disease (cvd) risk factors\] and psychological features (worsened quality of life and increased anxiety and depression) whether prolonged fasting during ramadan breaks the insulin resistance state of polycystic ovarian syndrome and subsequently improve the ovulation and spontaneous pregnancy will happen without ovarian stimulation.

question of the study: the question is raised whether prolonged fasting during ramadan breaks the insulin resistance state of polycystic ovarian syndrome and improve the metabolic syndrome does prolonged fasting decrease glucose level, insulin level, insulin resistance markers such as adipokines and subsequently improve ovarian function and causes spontaneous ovulation.

Eligibility criteria:
inclusion criteria: * females with pco in child bearing age who presented at reproductive and endocrinology clinics at ain shams university maternity hospital, and welling to fast for 30 days from 5 am until 7 pm and do not plan to induce her ovulation in the next 4 months to get pregnant. * does not have any other medical illnesses other than pco. * welling not to start any ovulation induction in the next 4 months after the first blood sample was taken and after fasting month. exclusion criteria: * known androgen secreting tumor. * pco on ovarian stimulation medications * pco with any other medical illness. * non-compliance with fasting 30 days from 5 am- 7 pm.