Kornimate/medical-research-clean huggingface dataset:
the clinical trial research of stem cell transplantation treats cerebral

Conditions: Stroke

Summary: all experimental group patients of 100 patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the first time transplantation. the control group gives injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

the control group of 20 patients accept injection through intravenous and lumbar puncture ways separately in the corresponding time, but the transplantation matter is physiological saline not the stem cell.

Eligibility criteria:
inclusion criteria: 1. all tested patients with cerebral infarction, cerebral hemorrhage must tally with the diagnosis standard which in 1995 the chinese fourth session of brain blood vessel of academic conference formulated, and after the head ct, mri confirmation. all patients should be taken bad completely within for 24 hours. 2. patient's age and gender: 40-65years，the gender is not limit; 3. the hemorrhage, block region：one side basis festival area, one side brain stem; 4. the patient must catch the apoplexy at the first time and the accidence causes the obvious clinical symptoms. exclusion criteria: 1. progressive apoplexy; 2. other internal organs strict illness sickness, like serious heart disease, diabetes, liver, kidney vigorous sickness and so on; 3. the patient with tumor in every system on there body; 4. having the primary or the sequential epilepsy medical history, within one year had the epileptic paroxysm; 5. can not accept mri inspection, for some metal implant in there body(such as inner support in heart or brain blood vessel).

Keywords: umbilical cord mesenchyma stem cell transplantation
viscoelastic properties of respiratory and peripheral muscles of copd patients

Conditions: COPD; Muscle Tone Abnormalities

Summary: the aim of this study was to compare the viscoelastic properties of auxiliary respiratory muscles and peripheral muscles of chronic obstructive pulmonary disease patients with healthy subjects. myotonometry was used to evaluate the viscoelastic properties of the muscles. the viscoelastic properties of the sternoclaidus mastoid, pectoralis major, upper trapezius, deltoid, biceps brachii, rectus femoris, gastrocinemius, and tibialis anterior muscles were evaluated.

muscle viscoelastic properties; muscle tone, stiffness and elasticity. these features may vary due to muscle overuse, lack of relaxation and recovery. the aim is to investigate these differences in copd patients and healthy individuals.

Eligibility criteria:
inclusion criteria: * male gender, * body mass index (bmi) between 18.5-29.9 kg/m2, * stable copd patients exclusion criteria: * being in the acute exacerbation period for copd patients, * having undergone any neurological, orthopaedic or thoracic surgery, * presence of malignancy in any organ, * presence of comorbidities affecting muscle atrophy (myasthenia gravis, muscular dystrophy, etc.).
window of opportunity trial, parp inhibitor rucaparib affect on pd-l1 expression in triple negative breast tumors

Conditions: Breast Cancer

Summary: this is a single arm window of opportunity trial conducted in patients with early stage triple negative breast tumors to evaluate if treatment with a poly(adp-ribose) polymerase (parp) inhibitor will increase expression of programmed cell death-1 with ligand (pd-l1) in triple negative breast tumors.

this is a single arm window of opportunity trial conducted in patients with early stage triple negative breast tumors. patients who are planning to undergo surgery as part of their initial treatment will be eligible for this study. they will be treated with single agent rucaparib for 3 weeks and then proceed to surgery. core-biopsies obtained at the time of diagnosis and tumor from the surgical resection will be assessed for change in expression of pd-l1 by immunohistochemical assay (ihc).

Eligibility criteria:
inclusion criteria: 1. have histologically documented triple negative breast cancer (tnbc) (defined as er expression ≤10% by ihc, progesterone receptor (pr) expression≤10% by ihc and her2 0 or 1+ by ihc or fluorescence in situ hybridization (fish) ratio \<2 or human epidermal growth factor receptor 2 (her2) gene copy number of \<6) 2. early stage breast cancer (stage i-iii) and not be candidate for neoadjuvant chemotherapy 3. be informed of the investigational nature of the study and all pertinent aspects of the trial 4. have eastern cooperative oncology group (ecog) performance status of 0-2 5. have the ability to understand and the willingness to sign a written informed consent document in accordance with institutional and federal guidelines 6. be ≥ 21 years of age 7. have serum creatinine \< 1.5 x institutional upper limit of normal (iuln) or a calculated creatinine clearance ≥ 30ml/min (calculated by cockcroft gault equation), bilirubin ≤ 2.0, and an serum glutamic oxaloacetic transaminase (sgot)/s erum glutamic pyruvic transaminase (sgpt)/alkaline phosphatase ≤ 2.0 x iuln 8. have adequate bone marrow function (anc \>1000, platelets \>100,000/ml, hemoglobin \>10gm/dl) 9. women of childbearing potential or male patients of reproductive potential with female partners of childbearing potential must not consider getting pregnant and must avoid pregnancy during the study and for at least 6 months after the last dose of rucaparib. female and male patients of reproductive potential must practice highly effective methods of contraception with their partners, if of reproductive potential, during treatment and for 6 months following last dose of rucaparib exclusion criteria: 1. ongoing or prior treatment with a parpi for breast cancer or other malignancies 2. receiving concurrent anti-neoplastic therapy for their breast cancer or another malignancy 3. known documented or suspected hypersensitivity to the components of the study drug or analogs. 4. pre-existing gastrointestinal disorders or defects (like duodenal stent etc) that would, in the opinion of the investigator, interfere with absorption of rucaparib

Keywords: breast cancer triple negative breast tumors pd-l1 parp parpi rucaparib
tropisetron on postoperative pain

Conditions: Pain, Postoperative

Summary: the role of 5-ht3a receptors in nociceptive processing has been demonstrated in several animal models. however, studies in human volunteers have not been reported except for one recent study suggesting that ondansetron could alleviate propofol-induced nociception. previous studies demonstrated that patients anaesthetized with sevoflurane have more pain than those anaesthetized with propofol. and we further posit that the difference is due to the nociceptive processing induced by the action of 5-ht3a receptors. in this prospective, randomized, double-blind, placebo-controlled study, we assessed the analgesic action of a 5-ht3a receptor antagonist (tropisetron) in women after gynaecological laparoscopy under general anaesthesia maintained with either sevoflurane or propofol.


Eligibility criteria:
inclusion criteria: * female patients * american society of anaesthesiologists physical status (asa-ps) i or ii * undergoing selective gynaecological laparoscopies for infertilities exclusion criteria: * aged under 18 years old * body mass index (bmi) \> 30 * history of cardiovascular disease * history of respiratory disease * history of neurologic disease * history of chronic antidepressants * history of anxiolytics * history of chronic analgesics intake * participating in other studies

Keywords: general anaesthetics gynaecological laparoscopy anaesthetic i.v. propofol anaesthetic volatile evoflurane antiemetics reopisetron postoperative pain
vascular and skeletal protective effects of genistein in postmenopausal women

Conditions: Menopause; Osteopenia

Summary: the present research program is proposed deepening some pharmacological effects of the genistein therapy in order to individualize alternative treatments to the conventional hormonal replacement therapy useful to reduce the cardiovascular morbidity and mortality and the osteoporotic consequences in postmenopausal women.

genistein is a phytoestrogen of the isoflavone family which has been shown to have beneficial effects on endothelial function and bone metabolism. on the basis of the so far obtained results, aim of our research was to investigate for a two years period the effects of genistein on cardiovascular risk factors, endothelial function and oxidative stress markers, bone metabolism and finally clarify pathophysiology mechanisms (by dosage of cytokines and endothelial markers) by which this molecule could interfere on atherosclerosis and bone mass loss progression. particularly, and in extreme synthesis the following parameters have been studied during the treatment: 1. inflammation markers as fibrinogen 2. lipid profile - total cholesterol, ldl cholesterol, hdl cholesterol, triglycerides, lipoprotein(a)- 3. endothelial function markers as vcam-1 and icam-1 4. oxidative stress by the evaluation of the f(2)-isoprostane 5. cytokines as il-6, opg, rank and rankl 6. bone mineral density, by dexa, at lumbar spine and femoral neck 7. bone turnover markers as b-alp, pyr, d-pyr 8. pap-test, transvaginal uterine ecography and mammography.

Eligibility criteria:
inclusion criteria: * at least one year of menopause * no use of hormone replacement therapy * bone mineral density t-score at the femoral neck minor than one s.d. exclusion criteria: * concomitant disease * smoke habit

Keywords: post-menopausal women osteoporosis phytoestrogen genistein
does preventive analgesia improve the outcome of demerol-vistaril procedural sedations in pediatric dentistry

Conditions: Pain

Summary: all healthcare providers strive continually to improve the outcome of their treatment approaches. the investigators hypothesize that preventive analgesics administered before a child is sedated with a demerol-vistaril regimen will improve the outcome of a sedation.

to increase outcomes for patients receiving dental sedation by providing significant evidence that the new regimen improves the quality of sedation and results in an improved post sedation ability to eat, drink, resume normal activities and require less additional pain medications.

Eligibility criteria:
inclusion criteria: * we intend to enroll 300 children between the ages of 2 - 8 years of all ethnicities for this prospective, placebo controlled, randomized, and double-blind trial. all children that fulfill our general selection criteria for this sedation regimen will be eligible for this study. exclusion criteria: * children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.

Keywords: analgesia
a phase ii study of cpc-201 to treat alzheimer's disease type dementia

Conditions: Alzheimer's Disease

Summary: this is a phase ii, single-blind, placebo-controlled, sequential treatment, multiple ascending dose study to evaluate the safety and tolerability of cpc-201 in patients with alzheimer's disease type dementia.


Eligibility criteria:
inclusion criteria: * aged 50 - 79 years inclusive. * meeting the diagnosis of probable alzheimer's disease * of moderate severity (mini-mental status exam \[mmse\] score 10 - 20 inclusive). * patients must be in generally good health as indicated by their medical history and physical examination, vital signs, electrocardiogram (ecg), and standard laboratory tests. exclusion criteria: * women of child bearing potential. * history or presence of a seizure disorder. * history of peptic ulcer disease, urinary or gastric retention; asthma or obstructive pulmonary disease. * history or presence of bladder outflow obstruction, gastrointestinal obstructive disorder or reduced gi motility, or narrow-angle glaucoma. * history or presence of gastrointestinal, hepatic, or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. * history or presence of myasthenia. * known hypersensitivity to donepezil, solifenacin or related drugs. * any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives. * patients who have participated in another clinical trial with an investigational drug within previous 30 days.
studio tiara: alessitimia ed emicrania cronica

Conditions: Migraine; Alexithymia

Summary: the aim of this observational, cross-sectional study is to investigate the relationship between alexithymia and migraine frequency (considering alexithymia a condition that can influence the severity of the clinical phenotype of migraine, favoring its chronicization), in an analysis adjusted for psychiatric comorbidity (for anxiety and depression, potentially influencing migraine chronicization) and for personalogical factor represented by apathy.


Eligibility criteria:
inclusion criteria: * diagnosis of episodic migraine with or without aura, chronic migraine and/or moh according to ichd-3 2018 criteria; * patients aged 12-65 years; * female patients exclusion criteria: * ongoing major depressive episode; * comorbidities for major internal diseases (hepatopathy, nephropathy, heart failure, etc.); * alcohol or substance abuse disorder (eoin, cocaine, cannabis, hallucinogens); * language barrier; * low cultural/cognitive level; * no informed consent.
prevention of uv-induced carcinogenic skin alterations in immunosuppressed solid organ transplanted patients

Conditions: Actinic Keratoses; Squamous Cell Carcinomas

Summary: the purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of md-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ transplant recipients.

this open-label multicenter, randomized, inter-individual comparative, prospective clinical trial was designed to evaluate the efficacy and safety of md 3511356 sunscreen in preventing ak and scc in post transplant immune-suppressed patients compared to standard of care. the present multicenter trial is intended to contribute to the evidence that daily sun protection will have a prophylactic effect in this high risk population of chronically immune compromised patients.

Eligibility criteria:
inclusion criteria: * out-patients of either sex aged ≥ 40 years * life-expectancy of 2 years at minimum * solid organ-transplant recipients who received a kidney (including pancreas), liver, lung, or heart transplant * patients treated for 5 years with an immunosuppressant medication * severe sun damage of the skin * multiple actinic keratoses (2-5 lesions) and/or multiple dysplastic naevi * no present squamous cell carcinoma, basal cell carcinoma or malignant melanoma; but history of cutaneous/cutaneous invasive malignancy with restitutio ad integrum is allowed * patients who are able to understand and provide written informed consent to participate in the clinical trial (signed informed consent) according to ich gcp exclusion criteria: * non-caucasian * absence of sun damage i.e. no signs of ak * multi-organ transplantation (exception: simultaneous transplantation of kidney and pancreas) * evidence of systemic infection, except viral hepatitis, at the time of recruitment * known or supposed systemic malignant tumour or systemic chemotherapy within the last 5 years prior to randomisation * patients participating in a clinical trial within the last four weeks before trial * patients treated with the antitumour/antiangiogenetic immunosuppressant sirolimus, respectively everolimus, or acitretin or any other systemic treatment for ak at the time of randomisation * patients treated with a topical drug for the ak at the time of randomisation (exception: excision or cryotherapy for hyperkeratotic lesions are allowed) * change of the immunosuppression-treatment less than 3 months ago or planned * present or planned interferon therapy (in liver transplant patients with hepatitis b/c) * female patients with childbearing potential with a positive pregnancy test, breast feeding, or female patients with childbearing potential without adequate contraception
efficacy of a physical activity counselling on the severity of chronic low back pain in patients with cardiovascular risk

Conditions: Low Back Pain; Physical Activity

Summary: objective: to determine the influence of a counseling of physical activity (pa) versus usual care (uc) in the magnitude of chronic pain (cp) in patients diagnosed with chronic low back pain (clbp). methods: a total of 64 subjects with (clbp) and older were randomly divided into two groups: an experimental group (uc) + counseling of (af) and control group (uc). each group consisted of 32 participants and were evaluated twice (pre and post-intervention), being spaced one month, both groups received telephone follow-up for their participation. the primary endpoint was the magnitude of the (cp) measured by the tool grading scale of chronic pain (egdc), while as secondary were considered the cardiovascular risk factors, catastrophism, kinesiofobia, disabled by back pain, quality of life, anxiety and depression and the (fa).


Eligibility criteria:
inclusion criteria: * patients with low back pain more than 3 months * age over 18 years old * low or medium cardiovascular risk exclusion criteria: * cardiovascular risk factors ≥ 5 * quirurgic procedures at spine last 10 years * past of cancer, or fibromialgia

Keywords: cardiovascular risk
contralateral study of wavelight® femtosecond laser devices for corneal flap creation

Conditions: Refractive Errors

Summary: the purpose of this study is to assess the wavelight ultraviolet femtosecond laser system, model 1026 (uv fs-laser) corneal flap creation accuracy as compared to the already marketed wavelight fs200 infrared femtosecond laser, model 1025 (ir fs-laser).

subjects who qualify to participate will have both eyes treated in the study (one eye with the uv fs-laser and the other eye with the ir fs-laser) and will attend a total of 5 study visits over a period of approximately 2 months. this study will be conducted outside the united states.

Eligibility criteria:
key inclusion criteria: * good ocular health; * natural lens with no evidence of cataract; * eligible for lasik; * stable refraction; * other protocol-defined inclusion criteria may apply. key exclusion criteria: * presence of dry eye; * contraindicated systemic disease or ocular conditions; * treatment with a contraindicated medication; * other protocol-defined exclusion criteria may apply.
us 10 ml biologic lung volume reduction (blvr) phase 2 emphysema study

Conditions: Pulmonary Emphysema

Summary: evaluate the efficacy and safety of the 10 ml blvr system in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

prospective, open-label, non-controlled, multi-center phase 2 study evaluating the efficacy and safety of the 10 ml blvr system in patients with advanced upper lobe predominant emphysema. twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. patients will be followed 96 weeks after completion of the final blvr treatment. all patients will receive standard medical therapy in addition to blvr treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of advanced upper lobe predominant emphysema * age \>/= 40 years * clinically significant dyspnea * failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic) * pulmonary function tests within protocol-specified ranges (post bronchodilator fev1 \ 110% predicted; rv \> 150% predicted) * 6 minute walk distance \>/= 150 m exclusion criteria: * alpha-1 protease inhibitor deficiency * homogeneous disease * tobacco use within 4 months of initial visit * body mass index \ 35 kg/m2 * clinically significant asthma, chronic bronchitis or bronchiectasis * allergy or sensitivity to procedural components * pregnant, lactating or unwilling to use birth control if required * prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endobronchial valve placement, airway stent placement or pleurodesis * comorbid condition that could adversely influence outcomes * inability to tolerate bronchoscopy under conscious sedation (or anesthesia)

Keywords: emphysema copd lung volume reduction nett blvr biologic lung volume reduction bronchoscopic lung volume reduction
extracorporeal shock-wave therapy for supraspinatus calcifying tendonitis: a randomized clinical trial comparing two different energy levels

Conditions: Supraspinatus Calcifying Tendonitis

Summary: the purpose of this study is to compare two different ranges of energy flux density with extracorporeal shock wave therapy in treatment of supraspinatus calcifying tendonitis.


Eligibility criteria:
inclusion criteria: * no visible clinical benefits by previous conservative treatment * medium and large calcific deposits, according to bosworth classiﬁcation * type i and ii gartner deposits exclusion criteria: * presence of tiny calcific deposits, according to bosworth classiﬁcation * type iii, according to the gartner classification * age (if less than 18 years old), diabetes, coagulation diseases or anticoagulant therapy, tumors, bone infections, previous shoulder surgery, pregnancy, pace-maker, acute bursitis demonstrated by ultrasound imaging, rheumatoid arthritis or other connective tissue diseases
recombinant human c1 inhibitor for the treatment of acute attacks in patients with hereditary angioedema

Conditions: Genetic Disorders

Summary: the purpose of this single-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human c1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.


Eligibility criteria:
main inclusion criteria: * clinical and laboratory diagnosis of hae * plasma level of functional c1inh of less than 50% of normal * severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral hae. main exclusion criteria: * acquired angioedema * pregnancy or breastfeeding * participation in another clinical study within prior 3 months