Kornimate/medical-research-clean huggingface dataset:
therapeutic effects of endoscopic ablation of hunner lesions in interstitial cystitis/ bladder pain syndrome patients

Conditions: Interstitial Cystitis

Summary: efficacy of endoscopic ablation of hunner lesions in patients with ic/bps and the characteristics of hls based on a long-term follow-up


Eligibility criteria:
inclusion criteria: 1. male and female aged 18 yrs or greater 2. patients diagnosed with bps(bladder pain syndrome) 3. symptom persisted more than 6 months 4. pain vas ≥4 5. o'leary-sant interstitial cystitis questionnaire (ic-q) scores 12 or greater with pain and nocturia domain scores \> 2. 6. pelvic pain and urgency/frequency patient symptom scale(puf) \>13 7. no history of cystoscopy within 2yrs. exclusion criteria: 1. history of augmentation cystoplasty or previous transurethral coagulation/resection due to bps 2. child-bearing potential, pregnant or nursing women. 3. mean voided volume lesser than 40ml or over than 400ml. 4. hematuria exceeds 1+ in the urinary dipstick (dipstick) examination. 5. urinary tract infection during run-in periods. 6. genitourinary tuberculosis or bladder,urethral and prostate cancer 7. recurrent urinary tract infection 8. history of hysterectomy,mid-urethral sling,pelvic organ prolapse repair,vaginal delivery or cesarean section,prostate operation or treatment etc within 6months. 9. neurologic disease history of cerebral infarction,multiple sclerosis or parkinsonism etc.-
impact of a nutritional intervention program for weight control during pregnancy

Conditions: Pregnancy Complications; Weight Gain

Summary: this is a randomized clinical trial for evaluate the impact of a nutritional intervention in the weight control of pregnant women according to the nutritional status, and consequently, the reduction of pregnancy complications. the sample of this study will be composed by 318 pregnant women in the pre-natal care unit of the health center in viamão city / rio grande do sul, including women between the 10th and 25th weeks of gestation, aged up to 35 years old. the eligible pregnant women will be invited by the fieldworks to participated in the trial after be informed about the overall aims of the study. these women willing to participate will be randomly allocated to either the intervention or control group. the intervention group received specific guidelines about feeding practices appropriate to each nutritional status. data on pregnant women will be collected through a questionnaire in both groups, and to assess the food intake, three 24-hour food recall will be applied in the interventional group and two recall in the control group, in initial and final gestational period. in all appointments pregnant women of the two groups will be weight and classified according to body mass index of pre-gestational (bmi). the dietary advices will be elaborated by the author of the project and nutrition graduation students of federal university of health science of porto alegre.


Eligibility criteria:
inclusion criteria: * women between the 10th and 25th weeks of gestation * to concern in the prenatal care group in basic health unit exclusion criteria: * pregnant with diseases that require specific treatment at the onset enrollment (hiv, diabetes, hypertension and anemia) * women 36 years or older.

Keywords: pregnancy prenatal care weight nutritional status
trastuzumab and trastuzumab-mcc-dm1 administered intravenously and gdc-0941 administered orally to patients with her2-positive metastatic breast cancer who have progressed on previous trastuzumab-based therapy

Conditions: Metastatic Breast Cancer

Summary: this multicenter, phase ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (po) gdc 0941 administered in combination with either intravenous (iv) infusion of t-dm1 or iv infusion of trastuzumab.


Eligibility criteria:
inclusion criteria: * histologically documented locally advanced or metastatic breast cancer that has progressed on at least one trastuzumab-based regimen in the metastatic or locally advanced setting * her2-positive disease documented by one of the following results using fda-approved testing methods: fish-positive, chromogenic in situ hybridization (cish)-positive, or ihc 3 + by local laboratory assessment * life expectancy \>= 90 days * agreement to use an effective form of contraception for the duration of the study exclusion criteria: * history of grade \>= 3 hypersensitivity reaction to trastuzumab, or grade \>= 1 with the most recent trastuzumab infusion before study entry, or continued requirement for prolonged trastuzumab infusions to prevent hypersensitivity reactions * history of intolerance to trastuzumab and/or adverse events related to trastuzumab that resulted in trastuzumab being permanently discontinued * prior anti-cancer therapy (e.g., biologic or other targeted therapy, chemotherapy, hormonal therapy) within 2 weeks prior to day 1 * prior investigational anti-cancer therapy within 4 weeks prior to day 1 * grade \>= 2 peripheral neuropathy * history of grade \>= 3 hyperglycemia (fasting) * history of type 1 or type 2 diabetes requiring daily medication * history of clinically significant cardiac or pulmonary dysfunction * history of malabsorption syndrome or other condition that would interfere with enteral absorption * clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hiv, hepatitis b virus, or hepatitis c virus * any condition requiring anticoagulants, such as warfarin, heparin, or thrombolytic agents * any condition requiring \> 2 grams of acetaminophen daily * need for current chronic corticosteroid therapy * pregnancy, lactation, or breast-feeding * current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) * major surgical procedure or significant traumatic injury within 28 days prior to day 1, or anticipation of the need for major surgery during the course of study treatment * symptomatic hypercalcemia requiring continued use of bisphosphonate therapy * known brain metastases that are untreated, symptomatic, or require therapy to control symptoms

Keywords: tdm-1 her2 her2+ her2+ breast cancer her-2 mbc trastuzumab emtansine
hfit versus tens study for chronic low back and knee pain

Conditions: Chronic Pain; Knee Pain Chronic; Back Pain, Low

Summary: a high-frequency impulse therapy (hfit) device (enso, san francisco, ca) is a portable device for the treatment of musculoskeletal pain. this three-arm randomized controlled trial study compares a hfit group to a standard transcutaneous electrical nerve stimulator (tens) group and a control group.


Eligibility criteria:
inclusion criteria: * age 18 or over and under age 65 * baseline pain is 40 or more out of 100 on a nprs * member of digital msk program's chronic back or knee pain program, after january 1, 2023 * member engaged in the most recent 3 weeks * experiencing chronic pain for at least 3 months * subject able to understand and provide informed consent * has an email account exclusion criteria: * diagnosis of cancer/malignant tumors in the last 5 years * back or knee surgery in the last 6 months * has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other implanted electronic device * patients with history of opioid, alcohol, or drug abuse in the last 1 year * cognitive, behavioral, neurologic, or psychiatric disorder (e.g., dementia, parkinson's, schizophrenia, stroke) that may interfere with the study or prevent the subject from complying with the requirements of the protocol * pregnant or plan on becoming pregnant in the next year * have epilepsy * have cardiovascular disease * current pain (in the past 24 hours) is less than 40 out of 100 on a nprs

Keywords: musculoskeletal chronic pain knee pain back pain
melatonin for sleep in children with autism

Conditions: Autistic Disorder; Insomnia

Summary: the purpose of this study is to determine if liquid supplemental melatonin is an effective treatment for children with autism who have sleep problems related to insomnia (difficulty falling asleep).

sleep difficulties in children with autism spectrum disorders (asd) are common reasons why parents seek medical intervention for their children. identifying a safe and effective pharmacologic agent that promotes sleep in asd would favorably impact the lives of these children and their families. in this study we plan to determine the dose-response, tolerability and any adverse effects of supplemental melatonin in 30 children with asd.the melatonin dose levels are 1mg, 3mg, 6mg, and 9mg. after a 3 week baseline period, the child will begin melatonin at 1mg and will dose escalate every three weeks until he/she is falling asleep within 30 minutes of bedtime at least 5/7 nights per week. no child will take more than 9 mg of supplemental melatonin.

Eligibility criteria:
inclusion criteria: * children with autism ages 4-10 years. * diagnosis of autism based on autism diagnostic observation schedule (ados). * time to fall asleep of 30 minutes or longer by parent report at least 3 nights/week in the last 3 months. * children may take seasonal allergy medications. * children may take the following medications for the same dose at least 3 months: citalopram (celexa), escitalopram (lexapro), amphetamine-dextroamphetamine (adderall), atomoxetine (strattera), methylphenidate(ritalin), dextroamphetamine(dexedrine), risperidone (risperdal. exclusion criteria: * children taking medications other than those in the inclusion criteria. * children with primary sleep disorder other than insomnia (such as sleep-disordered breathing). * children with non-febrile unprovoked epileptic seizure within the last two years. * children with liver disease or high fat diets, as melatonin metabolism may be affected in these children. * children who are visually impaired (partially or completely blind) as light suppresses melatonin synthesis and these children may have altered diurnal melatonin rhythms. * children with known genetic syndromes co-morbid with autism including fragile x, down syndrome, neurofibromatosis, or tuberous sclerosis. * children who have outside normal limits on blood work for complete blood count, liver and renal function and hormone levels of acth, cortisol, lh, fsh, prolactin, testosterone and estradiol. * tanner staging beyond level 1 at any time point in the study. * children whose assessment score does not place them on the autism spectrum.

Keywords: autism children sleep insomnia
cryocompression to reduce chemotherapy-induced peripheral neuropathy in gynecologic cancer

Conditions: Gynecologic Cancer; Chemotherapy-induced Peripheral Neuropathy

Summary: the aim of this study is to evaluate the effect of cryocompression therapy on the incidence and degree of taxane-induced peripheral neuropathy in gynecologic cancer patients receiving chemotherapy. subjects will serve as their own controls, and will be randomized to cryocompression therapy on their dominant versus non-dominant hand and foot, with standard of care treatment (no intervention) on the opposite hand and foot. compression therapy will be performed using commercially available compression socks and disposable surgical gloves, and cryotherapy will be achieved by applying bags of ice to the compression devices. subjects will complete baseline neuropathy surveys including the patient neurotoxicity questionnaire (pnq) and the functional assessment of cancer therapy (fact) -taxane (fact-ntx), which includes the sensory subscale of the fact-ntx. subjective symptoms will be assessed at baseline, before each cycle of chemotherapy and cryocompression, and one month after completion of 6 cycles. in addition, tactile sensation will be assessed with the monofilament test at baseline and one month after completion of 6 cycles of chemotherapy and cryocompression. the primary outcomes are the proportion of patients with pnq grade c or higher and decline in tactile sensitivity from baseline based on the monofilament test. the investigators hypothesize that cryocompression will reduce chemotherapy-induced peripheral neuropathy in patients with gynecologic cancer.


Eligibility criteria:
inclusion criteria: * gynecologic cancer diagnosis (ovarian, cervical, endometrial cancer; adenocarcinomas of likely primary gynecologic origin based on cytology or fna in conjunction with radiologic impression will be eligible) * plan to receive at least 6 cycles of paclitaxel administered every 3 weeks at duke cancer institute. patients receiving neoadjuvant chemotherapy with a plan for interval debulking will be eligible. * ecog performance status of 0-1 * latex allergy does not exclude a subject from the study. non-latex gloves will be provided. exclusion criteria: * treated with prior neurotoxic chemotherapeutic agents * baseline diagnosis of peripheral neuropathy such as diabetic neuropathy, or associated with conditions including but not limited to fibromyalgia, cryoglobulinemia and raynaud's disease.
a non-interventional study of rheumatoid arthritis patients treated with roactemra/actemra (tocilizumab) in monotherapy

Conditions: Rheumatoid Arthritis

Summary: this observational study will evaluate the use and efficacy of roactemra/actemra (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid arthritis. eligible participants initiated on roactemra/actemra treatment according to the licensed label will be followed for 6 months.


Eligibility criteria:
inclusion criteria: * adult participants, \>/= 18 years of age * moderate to severe rheumatoid arthritis according to the revised (1987) acr criteria * participants in whom the treating physician has made the decision to commence roactemra/actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that roactemra/actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received roactemra/actemra treatment within 8 weeks prior to the enrolment visit * concomitant treatment with nsaids and/or corticosteroids is allowed exclusion criteria: * participants who have received roactemra/actemra more than 8 weeks prior to the enrolment visit * participants who have previously received roactemra/actemra in a clinical trial or for compassionate use * participants receiving concomitant dmard treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study * participants who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra * participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
quantiferon change during anti-tuberculosis medication

Conditions: Tuberculosis; Interferon-gamma Release Assay

Summary: the aim of this study is to evaluate the change of quantiferon-tb gold in tube assay (qft) during the treatment of active tuberculosis.

patients with active pulmonary tuberculosis are enrolled and, qfts are performed for each subjects before treatment and 1, 3, 6 months after treatment. investigators check the level of interferon-gamma, and reversion and conversion of this test.

Eligibility criteria:
inclusion criteria: * all subjects with active tuberculosis exclusion criteria: * subjects who cannot complete study * subjects who have taken anti-tuberculosis medication for more than a month before visit of our hospital
the effect of stellate ganglion block on insomnia patients

Conditions: Insomnia

Summary: a prospective study was conducted on insomnia patients. all the patients were provided with stellate ganglion block. the quality of sleep was evaluated to see if stellate ganglion block can improve insomnia.

insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or experiencing non-restorative sleep, despite having adequate opportunity for sleep. it is a common condition that can significantly impact an individual's quality of life and overall well-being.a prospective study was conducted on insomnia patients. all the patients were provided with stellate ganglion block. the quality of sleep was evaluated to see if stellate ganglion block can improve insomnia.

Eligibility criteria:
inclusion criteria: * insomnia patients with the ages over 18. * meeting the diagnostic criteria for chronic insomnia as per the international classification of sleep disorders (icsd) or the diagnostic and statistical manual of mental disorders (dsm). * experiencing insomnia symptoms persistently for at least three months. * not currently using or ceased using medication for insomnia for at least four weeks. * willing to undergo stellate ganglion block treatment and participate in the study. exclusion criteria: * patients with severe cardiovascular disease, pulmonary disease, or other serious physical health issues. * pregnant or lactating women. * patients with mental disorders (such as major depression, anxiety disorders, schizophrenia, etc.) or cognitive impairments. * patients with known allergies or contraindications to stellate ganglion block treatment. * patients currently participating in other clinical trials or receiving experimental treatments.
tipranavir dose-response study using a prototype self-emulsifying drug delivery system (sedds) formulation in treatment-naive hiv-1 infected patients report on the post-study option, a treatment of triple therapy with delavirdine, zdv and 3tc without tipranavir

Conditions: HIV Infections

Summary: to investigate the safety of a standard triple therapy regimen of delavirdine (dlv), zidovudine (zdv), and lamivudine (3tc) following 14 days of experimental treatment with regimens of tipranavir (tpv) with and without ritonavir (rtv)


Eligibility criteria:
inclusion criteria: * hiv-1 rna ≥ 5,000 copies/ml by roche amplicor assay * cd4 cell count ≥ 50 cells/mm3 * karnofsky performance status ≥ 80 * age ≥ 13 years * screening laboratory values indicative of adequate baseline organ function, grade 0 or 1 for laboratory values based on the actg toxicity scale grade. selected stable \[2 months or longer\] grade 2 laboratory abnormalities were subject to sponsor's approval * acceptable medical history and physical examination * agreement to use a barrier contraceptive method for at least 1 month prior to the administration of the study medication, during the study, and for 30 days after the end of the study * signed informed consent * to enter the post-study option, patients have to have completed the 14-day tipranavir phase of the trial exclusion criteria: * previous treatment with any antiretroviral drugs for more than 2 weeks * clinically significant, active and/or acute (onset within the prior month) medical problems including opportunistic infections, such as active cryptococcosis, pneumocystis carinii pneumonia (pcp), herpes zoster, histoplasmosis or cytomegalovirus (cmv) , or non-opportunistic diseases including, but not limited to, progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy * history of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair compliance with the study * receipt of any known enzyme-inducing drugs including rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfamidine, sulfinpyrazone, or troleandomycin within 30 days prior to participation in the study * receipt of any investigational medication within 30 days prior to participation in the study * receipt of oral contraceptives within 30 days prior to participation in the study * pregnancy or lactation (serum ß-human chorionic gonadotropin (ß-hcg) test negative at second screen visit of the tipranavir phase of trial) * evidence of active substance abuse that, in the investigator's opinion, could affect study adherence * in the investigator's judgment, inability to comply with the protocol requirements for reasons other than those specified above
turkish version of telephone based abiloco-stroke

Conditions: Cultural Adaptation; Stroke; Reliability; Validity

Summary: the aims of this study were to perform cultural adaptation of the telephone based abiloco-stroke instrument and provide information regarding the factor structure, reliability and validity of the instrument in turkish speaking patients with stroke.


Eligibility criteria:
inclusion criteria: * hemiparetic individuals who were ≥ 18 years of age * were at least 4 weeks after the onset of the stroke * able to walk with or without assistive devices. exclusion criteria: * cognitive impairments * aphasia * any other non-stroke-related conditions.
a study to access of daratumumab combined with vrd in the treatment of patients with standard-risk newly diagnosed mm

Conditions: Newly Diagnosed Multiple Myeloma

Summary: this is an open-label, single arm study to access the effect of treatment with d-vrd in patients with newly diagnosed standard risk multiple myeloma.

research object:newly diagnosed standard-risk multiple myeloma (ndmm) diagnosed according to the international myeloma working group (imwg) standards and who have been assessed to receive autologous stem cell transplantation (asct) but actively refused.objective: to explore the therapeutic options of daratumamab (d) combined with bortezomib (v), lenalidomide (r) and dexamethasone ( d) for objective assessment of patients who can receive asct but not to receive transplantation.main indicators:negative rate of minimal residual disease (mrd) upon completion of cycle 8 (24 weeks).

Eligibility criteria:
inclusion criteria 1. age ≥ 18 years and ≤ 70 years, male or female； 2. newly diagnosed multiple myeloma (ndmm) ； 3. transplant-eligible； 4. non-17p-, t(4;14) , t(14;16)； 5. expected survival ≥12 weeks; 6. eastern cooperative oncology group (ecog) scores 0 - 2. 7. subjects should have adequate hemostatic and liver and kidney meet the following examination criteria: (without ongoing supportive treatments): 1. complete blood count (cbc) results: absolute neutrophil count（anc） ≥ 1.0 × 109/l, platelet count ≥ 75 × 109/l (if the proportion of plasma cells in the bone marrow is \> 50%, subjects with platelets ≥ 50 × 109/l will be eligible), hb ≥ 70 g/l. 2. blood biochemistry: creatinine clearance ≥ 30 ml/min, alanine aminotransferase (alt) ≤ 2.5 × upper limit normal (uln)，aspartate aminotransferase (ast) ≤ 2.5 × uln, total bilirubin ≤ 1.5 × uln. serum calcium ≤14.0 mg/dl (≤3.5 mmol/l); 8. normal cardiopulmonary function; 9. the patient agrees to join the clinical trial and signs an informed consent form. exclusion criteria 1. poor hypertension control; 2. have received asct or anti-tumor systemic therapy; 3. peripheral neuropathy or neuralgia of grade 2 or higher; 4. during pregnancy or lactation or planning to become pregnant; 5. history of other malignant tumors within 5 years; 6. subjects positive for any following tests: human immunodeficiency virus (hiv) antibody, treponema pallidum (syphilis) antibody, hepatitis c virus (hcv) antibody, hepatitis b virus (hbv) surface antigen (hbsag) and hbv dna. 7. participating in other clinical trials; 8. allergic to the drugs in the treatment plan; 9. receiving any other experimental drugs or experimental medical devices; 10. the investigator believes that the patient has other conditions that are not suitable for participating in this study. 11. patients with r-iss phase iii -