Kornimate/medical-research-clean huggingface dataset:
umbilical cord mesenchymal stem cells therapy (19#isclife®-sa) for patients with spinocerebellar ataxia

Conditions: Spinocerebellar Ataxia Type 1; Spinocerebellar Ataxia Type 2; Spinocerebellar Ataxia Type 3; Spinocerebellar Ataxia Type 6

Summary: the purpose of this study is verify the safety and efficacy of human umbilical cord mesenchymal stem cells (uc-msc) therapy for patients with spinocerebellar ataxia, and in addition, explore the possible mechanisms of uc-msc therapy in spinocerebellar ataxia.

this is a random, open label, and parallel controled experiment. 45 patients are selected and sign consent forms, then divided into three groups. doctors collect the basic information of patient (including age,height, mental condition, vital sign, history of disease, pharmaco-history, genotype test, and so on.) all patients receive laboratory and image examination as baseline. then, they will give cell treatment based on the clinical protocol. doctors have follow-up visit on 1, 2, 3, 6, and 12 months after treatment, and do efficacy evaluation.

Eligibility criteria:
inclusion criteria: * clinical and genomic test diagnoses as spinocerebellar ataxias (sca) (include sca 1, sca 2, sca 3, sca 6), sara (scale for assessment and rating of ataxia) score is 2-5, can complete 8-meter walking test（8mw） * do not receive stem cells treatment in 6 months * participants sign the consent form based on the experiment process and statement exclusion criteria: * cardiac, renal, hepatic insufficiency; total bilirubin is 1.5 times higher than normal value, aspartate transaminase（ast）or alanine aminotransferase（alt）is 2.5 times higher than normal value * hemogram: total white blood cells \<3.0 \* 10\^9 cells/l, blood platelet \<75 \* 10\^9/l, hemoglobin \<100g/l * pneumonia, or severe infection * with severe allergic history * brain organic disorder, like brain tumor * serum with hiv, syphilis antibody positive * severe mental disease, cognitive disorder patients * other severe system or organ organic disease * pregnant, breast feeding, or planning pregnant women * participate other clinical experiments in 3 months * with some other conditions that doctor propose not to participate

Keywords: spinocerebellar ataxia,mesenchymal stem cells
a study to investigate the use of hydrogel vehicle in maintaining the skin barrier in persons with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: while the repair of the epidermal barrier in atopic dermatitis is of major importance in the treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of an impaired epidermal barrier. hydrogel vehicle is anecdotally known to be moisturizing and hydrating.this study will compare the use of hydrogel vehicle and eucerin lotion in maintaining the epidermal barrier in subjects with atopic dermatitis.


Eligibility criteria:
inclusion criteria: * definitive diagnosis of atopic dermatitis as characterized by hanifin and rajka criteria: * 3 out of 4 major characteristics * at least 3 minor characteristics * mild to moderate disease score of 2 or 3 by investigator global assessment * minimum 5% body surface area at baseline * uniformly bilateral signs and symptoms of atopic dermatitis * able to understand and comply with the requirements of the study and sign informed consent/hipaa forms. subjects under the legal age of consent must also have written informed consent of the parent or legal guardian. exclusion criteria: * allergy or sensitivity to any component of the test articles. * subjects who have not complied with the proper washout periods for prohibited medications. * significant coagulation disorder or any medical condition that, in the opinion of the investigator, contraindicates the subject's participation in the study. * recent alcohol or drug abuse is evident. * history of poor cooperation, non-compliance with medical treatment or unreliability * participation in an investigational drug study within 30 days of the baseline visit.

Keywords: transepidermal water loss epidermal barrier skin hydration
natural sleep and drug-induced sleep endoscopy

Conditions: Obstructive Sleep Apnea

Summary: drug induced sleep endoscopy (dise) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea (osa). however, there are no studies comparing dise to sleep endoscopy during natural sleep. objectives: to compare dise to natural sleep endoscopy in osa patients referred for surgical treatment. methods: osa patients referred to surgical treatment (lateral pharyngoplasty) will be enrolled in this study. natural sleep endoscopy will be performed at the sleep lab during the night. propofol induced sleep will be performed at the operating room before surgery. the vote (velum, oropharyngeal lateral walls, tongue base and epiglottis) classification will be used to compare site and configuration of collapse between studies. peak inspiratory flow will also be compared between studies.

drug induced sleep endoscopy (dise) has been performed worldwide since 1991 to determine the site and configuration of upper airway obstruction in patients with obstructive sleep apnea. however, there are no studies comparing dise to sleep endoscopy during natural sleep. objective: to compare natural sleep endoscopy to drug induced sleep with propofol. the study population will include 28 patients who are candidates to surgical treatment. methods detailed clinical history and physical examination will be performed before natural sleep endoscopy. a 2-hour fast will be required. during both natural sleep and propofol-induced sleep, pharyngeal pressure will be measured using a pressure-tipped catheter (model tc-500xg; millar).the nasopharynx will be numbed with xylocaine (10%) and oxymetazoline (0.05%), the catheter will be passed through a nasal mask into one nostril, and placed at the tongue base as confirmed by visual inspection of the oropharynx.a 2.8mm pediatric bronchoscope (olympus) will be passed through the mask and into the other nostril. a nasal mask will be fitted and a heated pneumotachograph with differential pressure transducer connected to the mask will quantify airflow. the endoscope will be located at velopharynx, lateral wall of the pharynx and 2 cm above tongue and epiglottis.the vote endoscopic classification will be used to describe site and configuration of pharyngeal collapse in each study. the study will be scored by two experienced investigators, blind to the patient identification and type of study (natural sleep or drug-induced). propofol-induced sleep will be performed at the operating room before surgery.

Eligibility criteria:
inclusion criteria: * bmi less than 35kg/m2 * apnea-hypopnea index \> 5 events/hour of sleep * clinical indication of surgical treatment for sleep apnea exclusion criteria: * severe or decompensated cardiac or respiratory diseases * previous pharyngeal surgery * tonsils grade iii or iv * other sleep disturbance (parasomnias, primary insomnia, narcolepsy) * sedative medication use (opioids, benzodiazepines and muscle relaxants) * uncontrolled diabetes or hyperthyroidism

Keywords: sleep endoscopy sedation
aquatic therapy for freezing of gait in parkinson's disease patients

Conditions: Parkinson Disease; Gait Disorders, Neurologic; Gait Disorder, Sensorimotor

Summary: evaluation of the effectiveness of aquatic therapy for the treatment of freezing of gait in parkinson's disease patients undergoing a multidisciplinary and intensive rehabilitation treatment.

freezing of gait (fog) is an often dramatic, disabling episodic gait pattern that is common in parkinson's disease (pd). fog highly impairs mobility, causes falls, and reduces quality of life. given the limited effectiveness of both the dopaminergic therapy and the deep brain stimulation on this symptom, it represents a challenge in the field of rehabilitation. in the last years, some studies described the effectiveness of aquatic therapy on balance dysfunction in patients with pd, correlating it to the safe conditions offered by the aquatic environment and to the physical properties of water. nevertheless, the issues concerning the feasibility and the effectiveness of aquatic therapy for the treatment of fog have never been addressed before. the aquatic environment may act on the sensorial peripheral receptors, thus widely stimulating the proprioceptive system. pd patients show an altered processing of the proprioceptive information that could potentially underline fog. the investigators aim at investigating the effects of aquatic therapy for the treatment of fog in pd patients undergoing a multidisciplinary intensive rehabilitation treatment (mirt), whose effectiveness on several motor and functional parameters has been already demonstrated.

Eligibility criteria:
inclusion criteria: * diagnosis of pd according to gelb et al; * hoehn \& yahr (h\&y) stage 2.5-3; * presence of fog confirmed in the patient assessment prior to participation in the study; * stable pharmacological treatment for the last 8 weeks and during the rehabilitation period; * mini mental state examination (mmse) ≥ 24; exclusion criteria: * cardiac, pulmonary, vestibular and orthopedic diseases; * urinary incontinence; * severe dyskinesias; * patients treated with deep brain stimulation; * visual deficits; * comorbilities other than pd determining reduction of motor autonomy
glucotoxicity and acute exercise

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: experimental hyperglycemia (5 hours) will be induced via a constant- or fluctuating-rate glucose infusion to establish different patterns of glycemia in healthy individuals. the effects of these acute models of hyperglycemia on the adaptations to a single aerobic exercise bout will be tested. changes in pancreatic endocrine function, insulin sensitivity, endothelial function, and oxidative stress will be measured.


Eligibility criteria:
inclusion criteria for participation: * male * age 18-50 years * body mass index 19-30 kg/m2 * generally healthy exclusion criteria for participation: * regular use of anti-inflammatory medication * smokers * more than 2 kg weight change in prior 6 months * previous weight loss surgery * cancer, or evidence of chronic haematological, pulmonary, cardiac, hepatic, renal, or gastrointestinal disease * evidence of diabetes * engaged in moderate or vigorous activity on more than 5 days per week

Keywords: glucotoxicity exercise beta-cell function
single dose morphine and fentanyl added to intrathecal mixture on orthopedics patients with undiagnosed obstructive sleep apnea

Conditions: Obstructive Sleep Apnea of Adult

Summary: obstructive sleep apnea (osa) is a common clinical problem with a reported prevalence of 2% to 4% in the general population. the incidence was double on patients who had a diagnosis of osa going for orthopedics surgery. little literature composed mostly of case reports or small retrospective case-control studies exist examining the use of intrathecal opioids on outcomes in osa patients is inconclusive. the primary objective of this study is to compare the post operative respiratory effect after single dose intrathecal morphine and intrathecal fentanyl on orthopedics patients who suspected or undiagnosed obstructive sleep apnea. hypotheses undiagnosed osa patients who received intrathecal morphine are more likely to have respiratory events post-operatively.

this is a prospective, randomized study to compare the post operative respiratory effect after single dose intrathecal morphine (0.1mg) and intrathecal fentanyl (40mcg) on orthopedics patients who suspected or undiagnosed obstructive sleep apnea.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 2. asa i - ii 3. patients who admitted for orthopedic surgery and consented for regional anesthesia 4. stop - bang score ≥ 5 exclusion criteria: 1. refused to give informed consent 2. previous diagnosis and treatment of osa or any sleep-related breathing disorder 3. allergic to morphine / fentanyl / local anesthetic 4. contra-indicated for regional anesthesia 5. pregnant woman 6. contraindication to either of the oral analgesia as in protocol
improving diabetes outcomes for persons with severe mental illness

Conditions: Diabetes

Summary: persons with severe mental illness are at great risk for developing type 2 diabetes (t2dm). unfortunately, persons with mental illness and t2dm are less likely to receive recommended diabetes monitoring and are more likely to have poorly controlled diabetes, which leads to microvascular and macrovascular complications later in life. evidence-based diabetes self-management education and support interventions have yet to be adapted for persons with mental illness and there have been no randomized controlled trials (rcts) to examine their feasibility and efficacy. the purpose of this study is to assess the feasibility of conducting a rct of a diabetes self-management intervention for persons with severe mental illness and t2dm.


Eligibility criteria:
inclusion criteria: type 2 diabetes plus severe mental illness - exclusion criteria: none -
study to evalutate long-term immunity of hantavax in high risk population of hfrs

Conditions: Infection

Summary: this study was aimed evaluate long-term immunity response by neutralizing antibody test of adults in high risk population of hfrs .

this clinical trial was designed as a multicenter, non-comparable, open-label clinical trial.this trial was conducted written informed consent form by voluntary agreement, negative result of hantaanvirus antubidy by neutralizaing antibody test, test drug was administrated 0, 1, 13 months according to drug label. for antibody test, sampling was conducted pre-dose(t0), 1 month after vaccination(t1), 1 year after vaccination(before booster vaccination, t2) and 1 month after vaccination(t3). also, 1 month after vaccination (t3) after completion of booster vaccination for antibody retension duration observed for subjects with antibody to conduct a three-year follow-up survey was conducted, and the antibody test every year.in conclusion, sampling was conducted 12 months(t4), 24 months(t5), 36months(t6) after the booster vaccionation. however, follow-up survey was terminated when the antibody titer was determined as a negative by neutralizing antibody test and fluorescent antibody technique.

Eligibility criteria:
inclusion criteria: * the subjects who have the vaccination history of ah the time of screening * the subjects whose hantaan virus virus's antibody shows negative using neutralizing antibody test at the time of screening exclusion criteria: * the subjects who have a history of hemorrhagic fever with renal syndrome * the subjects who have a fever or significant dystrophy
safety and efficacy of obatoclax mesylate (gx15-070ms)for the treatment of myelodysplastic syndromes (mds)

Conditions: Myelodysplastic Syndromes

Summary: defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogeneic signal is present. obatoclax is designed to restore apoptosis through inhibition of the bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells. this is a multi-center, open-label, phase ii study of obatoclax administered in 2-week cycles to patients with previously-untreated myelodysplastic syndromes with anemia and/or thrombocytopenia. treatment may be administered on an outpatient basis. no investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. supportive care measures including those directed at controlling symptoms resulting from myelodysplastic syndromes are allowed


Eligibility criteria:
inclusion criteria: * pathological confirmation of myelodysplastic syndromes (mds) * patients must have had no prior systemic therapy * must have normal organ functions * must have the ability to understand and willingness to sign a written informed consent form exclusion criteria: * must not be a result of prior chemotherapy and/or radiotherapy for another malignancy * no other agents or therapies administered in the intent to treat * uncontrolled, intercurrent illness * pregnant women and women who are breast feeding
interdialytic peritoneal ultrafiltration in hemodialysis patients

Conditions: End Stage Renal Disease on Dialysis; Hemodialysis; Peritoneal Dialysis; Nonosmotic Sodium Storage

Summary: sodium accumulates in the tissues of patients with kidney disease and impairs survival. three-times weekly, standard hemodialysis alone cannot remove excess sodium efficiently. a sample of 10 chronic hemodialysis patients will undergo a 5-week, pilot, interventional study to test the efficacy of additional sodium removal in-between hemodialysis sessions, twice per week, for three weeks. tissue sodium removal will be achieved with peritoneal dialysis after the surgical insertion of a peritoneal dialysis catheter. tissue sodium removal will be assessed at the beginning and at the end of the study with sodium magnetic resonance imaging of a peripheral limb (leg). patients will also undergo monitoring for symptoms and blood pressure throughout the study to assess the safety of this procedure.

hypothesis: interdialytic peritoneal ultrafiltration (ipuf) via tenckhoff peritoneal dialysis catheter using 10% dextrose infusate is feasible and provides effective volume management and sodium removal in prevalent hd patients. overview: this is a prospective, interventional pilot study from the london health sciences centre (lhsc) prevalent hd population. study patients will undergo the surgical implantation of a tenckhoff peritoneal dialysis catheter before study start. after the successful insertion of the tenckhoff catheter, study patients will enter a run-in phase, where their residual renal function, volume, hemodynamic and cardiac status during hd will be assessed. during the following weeks (intervention weeks 1, 2, 3), study patients will receive in-center ipuf intervention, consisting of peritoneal infusate instillation of a 10% dextrose solution via a tenckhoff catheter, immediately after the first two hd sessions of the week (monday, wednesday); the infusate will be dwelling in the study patient's peritoneal cavity for 2 hours, at the end of which the solution will be drained and the patient sent home. study patients will be monitored during infusate administration and for the first four hours thereafter. the study intervention will be discontinued at the beginning of week 5 (wash-out); during week 5 and the first hd session of week 6, study patients will be monitored to observe potential residual effects of the ipuf intervention.

Eligibility criteria:
inclusion criteria * at least one of the following: * average per-session interdialytic weight gain ≥ 4.0 % of their dry weight in the last month; * inability to consistently achieve dry weight with the current treatment schedule; * need for additional hd treatments to achieve prescribed dry weight. * weekly hd sessions - up to three times/week * age ≥18 years * willing and able to give informed consent exclusion criteria * contraindications to peritoneal dialysis * contraindications to mri * uncontrolled diabetes mellitus * active infections * non-compliance to hemodialysis prescription * pre-study serum sodium \< 130 mmol/l
costs, efficiency and the role of management in hiv prevention interventions for female sex workers in nigeria

Conditions: HIV/AIDS

Summary: this study seeks to measure the costs associated with hiv prevention service delivery to female sex workers (fsw) in nigeria, as well as examine the relationship between management practices at the community-based organizations (cbos) and costs. to complete these goals, the study will collect both retrospective and prospective data from cbos and from centralized information from study partners (society for family health, sfh). in the prospective section of the study, cbos will be sampled and assigned to either treatment or control groups. data collected at the cbos will be aggregated by the cbo managers, and those in the treatment group will receive feedback on their performance on a monthly basis. those in the treatment group will additionally receive a management training to guide their management practices. researchers hypothesize that there will be improvements in management indicators and therefore decreases in costs at cbos in the treatment group. results will be disseminated to local, national, and international stakeholders.


Eligibility criteria:
inclusion criteria: * clusters: community-based organizations that serve female sex workers under society for family health, through the ships or global fund grants * participants: managers ("officers") that oversee the functions of the organization and supervise volunteer staff exclusion criteria: * clusters: excludes organizations not serving female sex workers and not working under society for family health, through global fund or ships grants * participants: excludes anyone not explicitly working as a manager overseeing volunteer implementation

Keywords: costing behavioral intervention management
shaping the health of adolescents in zimbabwe

Conditions: HIV

Summary: the shaz! study was a randomized trial that compared a package of life skills education, reproductive health care services, and economic livelihood development to a control package of life skills education and reproductive health care services alone. shaz! enrolled young women 16 to 19 years old who had been orphaned and who were currently out of school and not infected with hiv. individuals participated in the project for up to two years.


Eligibility criteria:
inclusion criteria: * 16 to 19 years old * out of school * orphaned * willing to participate in intervention activities * living in chitungwiza exclusion criteria: * hiv infection * currently pregnant

Keywords: hiv adolescents
phase ii trial of combined modality treatment in primary central nervous system lymphoma

Conditions: Lymphoma, B Cell

Summary: aim of the study is to establish in a prospective, randomized clinical trial the activity of primary chemotherapy containing high dose-methotrexate, alone or combined with high dose cytarabine, in patients with primary central nervous system lymphoma


Eligibility criteria:
inclusion criteria: 1. histological or cytological diagnosis of non-hodgkin's lymphoma. 2. diagnostic sample obtained by stereotactic or surgical biopsy, csf cytology examination or vitrectomy. 3. disease exclusively localized into the central nervous system, cranial nerves or eyes. 4. untreated patients (patients treated with steroids alone are eligible). 5. at least one measurable lesion. 6. age 18 - 75 years. 7. ecog performance status \< 3 8. hbsag-negative and ab anti-hcv-negative serologic status. 9. no known hiv disease or immunodeficiency. 10. adequate bone marrow (plt \> 100000 mm3, hb ≥ 9 g/dl, anc ≥ 2.000 mm3), renal (creatinine clearance ≥ 60 ml/min), cardiac (vef ≥ 50%), and hepatic function (total serum bilirubin \< 3 mg/dl, ast/alt and ggt \< 2 per upper normal limit value). 11. no previous or concurrent malignancies with the exception of surgically cured cervical intraepithelial neoplasia type 1 (cin1) or localized non-melanomatous skin cancer and of other cancers without evidence of disease since at least 5 years (patients with a previous lymphoma diagnosis will be excluded). 12. absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 13. non-pregnant and non-lactating status for female patients. adequate contraceptive measures during study participation for sexually active patients of childbearing potential. 14. no concurrent treatment with other experimental drugs. 15. informed consent signed by the patient before registration