Kornimate/medical-research-clean huggingface dataset:
study of oral elagolix tablets in combination with combined oral contraceptive capsules/tablets to assess dysmenorrhea response in adult female participants with endometriosis and associated moderate to severe pain

Conditions: Endometriosis

Summary: endometriosis is a painful disorder of the uterus affecting 6-10% of women of childbearing age. endometriosis affects daily activities, social relationships, sexuality and sexual activity, and mental health. this study will evaluate how well elagolix in combination with combined oral contraceptives (coc) works within the body and/or how safe it is compared to placebo (does not contain treatment drug). this study will assess the dysmenorrhea (painful periods) response in participants with endometriosis and associated pain. elagolix is an approved drug for the management of moderate to severe pain associated with endometriosis. participants are randomly put in 1 of 3 groups, called treatment arms. each group receives a different treatment. there is a 1 in 3 chance that participants will be assigned to placebo. adult female participants who still have periods with a diagnosis of endometriosis will be enrolled. around 800 participants will be enrolled in the study at multiple sites in the united states, including puerto rico. participants will receive oral elagolix or placebo tablets in combination with combined oral contraceptive (coc) or placebo capsules for 3 months. all the participants will receive elagolix tablets in combination with coc tablets from month 4 through month 18. there will be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular visits during the course of the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * documented surgical confirmation of endometriosis and associated moderate to severe pain. * participants must agree to use dual non-hormonal methods of contraception consistently during washout (if applicable), screening, and 3-month double-blind placebo-controlled treatment periods of the study. * participant, in the investigator's opinion must be an appropriate candidate to receive combined oral contraceptives (cocs). exclusion criteria: * pregnant or breastfeeding or planning a pregnancy until completion of the study. * surgical history of hysterectomy or bilateral oophorectomy. * participant has osteoporosis or other metabolic bone disease or clinically significant gynecological findings from screening. * participant has any other active chronic pain condition that would interfere with their assessment of endometriosis-related pain.

Keywords: endometriosis elagolix combined oral contraceptives (coc) orilissa dysmenorrhea
care transitions in renal disease patients

Conditions: Renal Disease

Summary: the goal of this pilot is to reduce the 30-day hospital readmission rate for dialysis patients. it is a quality improvement project that consistent of 4 "tracks." tracks 1 \& 2: implement use of checklists of activities for staff to complete when patients are admitted to the hospital, and post-hospitalization with emphasis on fluid assessment, nutrition management, patient coaching, and communication between institutions. track 3: work with physicians to develop process to individualize post-hospitalization dialysis orders and improve medication reconciliation. track 4: use a renal care transitions case manager to follow patients in the hospital and 30 days post-hospitalization to facilitate care and patient coaching.


Eligibility criteria:
inclusion criteria: * chronic hemodialysis patients * all patients admitted to the hospital during the study period exclusion criteria: * patients \<18 years old
sleep problems in epileptic children and their caregivers

Conditions: Epileptic Children,Sleep Disturbances,Maladaptive Behaviors

Summary: the aim of this study is to investigate the frequency of sleep problems in epileptic children and their caregivers.

the study instruments include two parts. first, data on socio-demographic, height, weight, the sleep duration, caregiver's level of education (illiterate, preliminary school, high school, university), caregiver sleep problems, and medical background were noted. clinical data regarding epilepsy (a type of seizure, etiology, the frequency of seizures, actual and previous antiseizure medications) were collected from interviews of participants/parents and examination. second, the psychometric assessment tools used to evaluate all participants and caregivers; children's sleep habits questionnaire (cshq), strength and difficulties questionnaire (sdq), diagnostic and statistical manual of mental disorders (dsm)-v sleep disorders scale-child report, dsm-v sleep disorder scale- adult report. all participants and their caregivers completed the psychometric questionnaires.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of epilepsy that based on the international league against epilepsy (ilae) operational clinical definition criteria for epilepsy * must be diagnosed by pediatric neurologists * must receive treatment for at least one year. exclusion criteria: * to have an iq ≤80, as measured by the wechsler intelligence scale for children-revised form (wisc-r) or below-average academic performance documented by last year's final school grade * to have a history of psychiatric, developmental disorder, or psychosis * to have a history of progressive neurological disorder other than epilepsy * to have any complaint (e.g., behavior problems, depression, or anxiety) that could interfere with sleep * to have a caregiver who has any medical or psychiatric condition (e.g., depression or anxiety) that could interfere with sleep.

Keywords: children epilepsy cshq sdq caregiver sleep disturbances
adagio follow up study: evaluation of the long-term effects of rasagiline in parkinson's disease subjects

Conditions: Parkinson's Disease

Summary: eligible participants, who participated in the adagio trial and who sign an approved informed consent form, will be enrolled into the study at their original study locations. participants who have stopped rasagiline therapy and in the opinion of the investigator will gain clinical benefit from restarting treatment can also be considered for enrollment in the core follow-up study period. use of any other anti-pd treatment is permitted as deemed necessary by the treating physician (according to the participants clinical status).


Eligibility criteria:
inclusion criteria: 1. subjects who participated in the adagio study, and who entered the active phase of the study and 2. subjects who are currently on rasagiline treatment (or subjects who have stopped rasagiline treatment, are willing to restart treatment, and in the opinion of the investigator will gain clinical benefit from restarting treatment) and 3. subjects with a diagnosis of parkinson's disease and 4. subjects willing and able to give written informed consent exclusion criteria: 1. subjects who have discontinued rasagiline treatment due to an adverse event and have not restarted rasagiline treatment subsequently. 2. subjects who cannot be given rasagiline due to any exclusion based on the local label (including pregnancy or nursing women) or due to the use of medications contraindicated for concomitant use with rasagiline according to local label 3. subjects with a medical condition that is considered by the investigator as significant enough to prevent participation

Keywords: parkinson's long-term effects adagio rasagiline delayed start
a study to evaluate the efficacy and safety of ibi302 insubjects with diabetic macular edema（dme）

Conditions: Diabetic Macular Oedema

Summary: the study is designed for multi-center,randomized,double-masked,active-contralledstudy to evaluate effective and security of intravitrealinjection of ibi302 in subjects with diabetic macular oedema.


Eligibility criteria:
inclusion criteria： * informed consent form (icf) must be signed before participating in the study, compliance is good, and willing to complete the visit as planned; * subjects aged 18-80 years (inclusive) at the time of screening, and diagnosed with type i or type ii diabetes; * dme involved the macular fovea at screening; * cst≥320 μm as confirmed by oct in the study eye at screening. * at baseline, visual acuity loss in the study eye due to dme with bcva ranging from 19 to 78 etdrs letters (inclusive); * currently use of insulin, or other injectable drugs, or oral hypoglycemic agents to treat diabetes, hba1c ≤10% at screening; exclusion criteria： eye disease * high-risk pdr in the study eye; * dense hard exudation that destroyed the fovea structure of the macula in the study eye; * iris neovascularization in the study eye; * other systemic/ocular disease associated with the study eye may cause subjects fail to respond to study treatment or confuse the interpretation of study findings; * uncontrolled glaucoma in the study eye; eye treatment * any previous treatment with ibi302 in the study eye before baseline; * intravitreal injection of anti-vegf or anti-complement agents in the study eye within 90 days prior to baseline; * panretinal photocoagulation or macular laser (focal, grid or micropulse) in the study eye within 90 days prior to baseline; * cataract surgery was performed in the study eye within 90 days prior to baseline; * yag laser capsulotomy or yag laser peripheral iridotomy were performed in the study eye within 90 days prior to baseline. * any other intraocular surgery (eg, corneal transplantation, glaucoma filtration, pars plana vitrectomy, or radiotherapy) systemic diseases/treatments * currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable antidiabetic medication \<90 days prior to administration. * uncontrolled hypertension. * systemic use of anti-vegf or anti-complement agents within 90 days prior to baseline * the presence of any other pre-existing disease, metabolic disorder, abnormal results on a physical examination or clinical laboratory examination that may reasonably be suspected of causing contraindications with the investigational drug, or affecting the interpretation of study results, or placing subjects at high risk of treatment complications (e.g., coagulation dysfunction, history of acute cardiovascular and cerebrovascular disease, history of treated or untreated malignancies within the past 5 years, etc.); * systemic treatment for suspected or active systemic infection (e.g., tuberculosis, hepatitis b, hepatitis c, etc.); * pregnant or lactating women.
phase ii study of avastin + erbitux + irinotecan as 2nd line treatment of colorectal cancer

Conditions: Colorectal Cancer

Summary: this phase ii study will evaluate the efficacy of the combination of two monoclonal antibodies (avastin + erbitux) with irinotecan, in patients with colorectal cancer progressed after 1st line treatment with folfiri avastin or xeliri avastin.

treating patients with primary resistance to the most active multi-agent combination remains a challenging clinical problem. the reported data demonstrated that addition of erbitux may reverse irinotecan resistance. further data support the feasibility of the combination of two monoclonal antibodies (avastin+erbitux) with irinotecan with better responses compared to historical controls (erbitux±irinotecan). as such, a phase ii study was designed to evaluate the efficacy of the combination of avastin plus erbitux plus irinotecan as second line treatment in patients progressing while on treatment with folfiri avastin or xeliri avastin

Eligibility criteria:
inclusion criteria: * histologically confirmed locally advanced or metastatic colorectal cancer. * measurable or evaluable disease according to the response evaluation criteria in solid tumors (recist) * ecog performance status ≤ 2 * age 18 - 72 years * patients with de novo refractory disease (progression of disease as best response at 1st line therapy with folfox/avastin) * adequate liver (bilirubin ≤ 1.5 unl, sgot/sgpt ≤ 4 unl, alp ≤ 2.5 unl),renal (creatinine ≤ 1.5 unl) and bone marrow (anc ≥ 1,500/mm3, plt ≥100,000/mm3) function * patients must be able to understand the nature of this study * written informed consent exclusion criteria: * history of serious cardiac disease (unstable angina, congestive heart failure, uncontrolled cardiac arrhythmias). * history of myocardial infarction or stroke within 6 months. * clinically significant peripheral vascular disease. * history of abdominal fistula, gastrointestinal perforation or intraabdominal abscess within 28 days prior to day 0. * presence of central nervous system or brain mets. * evidence of bleeding diathesis or coagulopathy. * patients with known hypersensitive reaction to cetuximab * blood pressure \> 150/100 mmhg. * pregnant or lactating woman. * life expectancy \< 3 months. * previous radiotherapy within the last 4 weeks or \> 25% of bone marrow. * metastatic infiltration of the liver \>50%. * patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction or total colectomy. * active infection requiring antibiotics on day 1. * second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer. * psychiatric illness or social situation that would preclude study compliance.

Keywords: metastatic colorectal cancer second line irinotecan erbitux (cetuximab) avastin (bevacizumab)
allergy potential of omeza collagen matrix in human subjects using the skin prick method

Conditions: Allergic Reaction

Summary: single-center, monadic, one day study utilizing the skin prick method to assess the allergy potential of omeza collagen matrix in human subjects


Eligibility criteria:
inclusion criteria: 1. healthy volunteers aged 18 years of age and older as demonstrated by selfreported medical history, concurrent medication, and a brief dermal skin assessment of the test sites; 2. fully informed of the risks of entering the study and willing to provide written informed consent and hipaa authorization to disclose protected health information; 3. subject has normal healthy skin on the either volar forearm. exclusion criteria: subjects must be excluded if any of the following conditions exist: 1. self-reported pregnant or nursing at the screening visit; 2. clinically significant skin disease which may contraindicate participation, including psoriasis, eczema, atopic dermatitis, and active cancer; 3. history of drug abuse or current drug user; 4. treatment with antihistamine or steroid (any route) administered within the last 7 days; 5. history of anaphylaxis to matrix ingredients (e.g. fish, palm oil, hemp oil, beeswax); 6. persistent severe/ unstable asthma; 7. subjects on beta blockers and/or ace inhibitors; 8. medical condition which in the opinion of the investigator would compromise the safety of the subject or confound study results (subjects with the following conditions: chronic renal failure, cva, cancer, spinal cord injury, diabetic neuropathy, recent anaphylaxis, limbs affected by lymphoedema, paralysis, or neurogenic abnormalities; 9. diabetic (type 1 or 2); 10. subjects taking the following: antidepressants such as doxepin, other tricyclics, phenothiazines, and tetracyclics within the last two weeks; 11. subjects taking otc cold and flu remedies, "sinus" analgesics, antitussives, antiemetics, sedatives, relaxants, migraine prophylactics (cyproheptadine, pizotifen); 12. prolonged use of topical corticosteroids; 13. use of topical moisturizers on the volar forearms; 14. dermographism "writing on the skin" - common localized hive reaction, characterized by the abrupt onset of welts and hives where the skin is exposed to pressure, scratching, itching, or stroking; 15. investigator deems the subject an unsuitable candidate for this study.
pci in advanced triple negative breast cancer patients who response to 1st line chemotherapy

Conditions: Breast Cancer; Brain Metastasis

Summary: the purpose of this study is to compare whether prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy could prolong brain-metastasis free survival.

this is a phase iii, randomized, controlled, open, multicenter clinical trial, designed to assess the efficacy and safety of prophylactic cranial irradiation (pci) in advanced triple negative breast cancer who response to the first line chemotherapy. compare the pci group with the observation group to evaluate brain metastasis-free survival,cumulative risk of brain metastases within 1 year,progression-free survival,overall survival,quality of life measured by the the europe organization for research and treatment of cancer, quality of life questionnaire-cancer 30 (eortc-qlq-c30) questionnaire score and function of central nervous measured by the the europe organization for research and treatment of cancer, quality of life questionnaire-brain cancer 20 (eortc-qlq-bn20) questionnaire score in women with advanced triple negative breast cancer who response to the first line chemotherapy.

Eligibility criteria:
inclusion criteria: 1. signed informed consent; 2. age of 18 to 65 years; 3. documented advanced breast cancer, clinical and pathological confirmed; 4. immunohistochemical examination:er\<1%+, progestin receptor (pr)\<1%+, her-2 -/+ or her-2(++)with negative result of fish; 5. a response after four to eight cycles of first line chemotherapy; 6. life expectancy longer than six months evaluated by investigator; 7. a performance status of 0 to 2, according to the criteria of the world health organization (with a higher score indicating a poorer performance status) 8. less than grade 1( common terminology criteria grade version 4.0) of treatment-related toxicities; 9. adequate baseline organ function. exclusion criteria: 1. history of another malignancy. 2. pregnancy or gestation 3. definite diagnosed of central nervous system (cns)or leptomeningeal metastases 4. serious cardiac illness or medical condition 5. known history of related central nervous system or leptomeningeal disease 6. cognition impairment or suffering from mental illness 7. demand a long-term oral administration of psychotropic drugs 8. have a concurrent disease or condition that may interfere with study participation, or any serious medical disorder that would interfere with the subject's safety (for example, active or uncontrolled infection, currently active/requiring anti-viral therapy hepatic or biliary disease)

Keywords: phase 3 randomized controlled trial prophylactic cranial irradiation triple negative breast cancer brain metastasis advanced breast cancer
prospective evaluation of an rdt to screen for gambiense hat and diagnose p. falciparum malaria

Conditions: Human African Trypanosomiasis

Summary: a prototype rapid diagnostic test (rdt) to simultaneously screen for gambiense human african trypanosomiasis (hat) and diagnose p. falciparum malaria (the "hat/malaria combo") has recently been developed. the performance of this prototype has been evaluated in a retrospective study that showed that its diagnostic performance for hat and malaria was equivalent to the performance of the sd bioline hat 2.0 and the sd bioline malaria ag p.f tests, respectively. the purpose of this study is to prospectively evaluate the performance of the test in settings where p. falciparum malaria is endemic, and which are either endemic or non-endemic for hat. this will enable the assessment of the suitability of the hat/malaria combo rdt as a diagnostic test for malaria, and a screening test for hat in pre-elimination and post-elimination contexts, respectively.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 6 years * provision of signed informed consent. for children (under the age of 18) provision of signed informed consent by a parent or legal guardian and an age appropriate assent. exclusion criteria: * severe anaemia preventing collection of a sample of venous blood * severe medical condition preventing informed consent and trial participation (e.g. coma, cognitive impairment, etc.) * for hat true negatives only: history of previous hat infection
robotic and conventional hand therapy after stroke

Conditions: Stroke

Summary: weakness is a major cause of disability in stroke survivors. rehabilitation techniques are often not effective in restoring full function of the upper limb. specifically, many individuals remain with weakness in the hand, preventing its return to full use. robotic therapies have been developed as exercise tools for stroke survivors. devices, such as the inmotion2, have been shown to be useful in restoring some motor function in the upper limb. however, most existing devices designed to be used with the upper limb have primarily been developed to treat the shoulder, elbow and wrist. they have not specifically addressed hand function. tyromotion, inc. has developed the amadeo, which is primarily intended to provide rehabilitation for patients with neurological or orthopedic deficits in hand function. initial clinical testing has demonstrated the practicality of using this device in a population of stroke survivors, although further research is needed to better understand the usefulness of the amadeo device as compared with conventional rehabilitation methods. the purpose of this study was to compare results of training with the amadeo device or training with conventional therapies. a total of 28 subjects from two separate sites participated in the study and underwent baseline testing of upper limb motor and sensory performance and function. subjects were then assigned to one of two treatment groups with a 50:50 chance of being in either group. one group underwent training with the amadeo device and the other group underwent training with conventional therapy. all training sessions were 60 minutes in duration, three days/week for eight weeks (24 total sessions). subjects were reassessed on completion of the training program.


Eligibility criteria:
inclusion criteria: * history of stroke (\>3 months from time of ictus) * paresis or plegia of the upper extremity. exclusion criteria: * severe spasticity (defined on the ashworth scale with a score of 4-5) * severe pain despite conventional pain therapy of the paretic upper extremity * swelling, infection, fracture or ulcers of the paretic extremity * arthritis of the hand joints * pregnant * botulinum toxin- therapy to the upper extremity within 3 months prior to study entry * severe contractions
implementation study with decision support based on data

Conditions: Urinary Tract Infections

Summary: this study evaluates the implementation of a machine learning based clinical decision support system for treatment of patients presenting with an urinary tract infection in general practice. the software was developed to support general practitioners in the choice of antibiotic regimen.


Eligibility criteria:
inclusion criteria: * patients with a urinary tract infection in general practice * age \> 12 years. exclusion criteria: * no.

Keywords: machine learning clinical decision support systems