Kornimate/medical-research-clean huggingface dataset:
to evaluate the efficacy and safety of hsk16149 with l-carnitine in diabetic peripheral neuralgia patients in china

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: observe the effects of hsk16149 capsule combined with acetyl-l-carnitine hydrochloride tablets and lipoic acid combined with acetyl-l-carnitine hydrochloride tablets efficacy and safety in diabetic peripheral neuralgia patients in china

observe the effects of hsk16149 capsule combined with acetyl-l-carnitine hydrochloride tablets and lipoic acid combined with acetyl-l-carnitine hydrochloride tablets efficacy and safety in diabetic peripheral neuralgia patients in china.

Eligibility criteria:
inclusion criteria: 1. able to understand and voluntarily sign written informed consent; 2. male or female over the age of 18 (including the threshold); 3. diabetic peripheral neuralgia (dpnp) diagnosis; 4. the average pain visual analogue scale (vas) score in the past 24 h was assessed as ≥ 40 mm and \< 90 mm during screening. exclusion criteria: * 1. peripheral neuropathy or pain unrelated to dpn that the investigator determined might confuse the dpnp assessment; 2. history of malignant tumors (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary thyroid carcinoma) or history of antitumor therapy within 5 years prior to screening; 3. severe abnormal liver and kidney function, meeting any of the following clinical laboratory test results: 1. liver function: alanine aminotransferase (alt) or aspartate aminotransferase (ast) \> 2.5 × upper limit of normal (uln); or total bilirubin (tbil) \> 1.5 × uln; 2. estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73 m2 (calculated according to simplified mdrd formula); 4. known allergic history to test drug components or other drugs or excipients with similar chemical structure; 5. past suicidal behavior or suicidal intention; 6. women who are pregnant, planning to become pregnant during the study period, or breastfeeding; women who do not wish to use reliable contraceptive methods (including condoms, spermicides, or iuds) for 28 days after signing up for the icf from the beginning to the last trial drug administration, or who plan to use progesterone contraceptives during this period; 7. participated in any other clinical studies within 30 days prior to screening; 8. the researcher determines that there are other conditions that are not suitable for participation in this study.
sleep quality & spinal cord injury

Conditions: Sleep Disorder

Summary: the aim of the study was to evaluate sleep quality in patients with spinal cord injury; to investigate the relationship between sleep and spinal cord level, ambulation status, spasticity, quality of life, daily living activities, depressive status, neuropathic pain

since survival increases in patients with spinal cord injury, sleep disturbances, which are more frequently observed than the general population and have significant impacts on mortality, impair long-term quality of life.the aim of the study was to evaluate sleep quality in patients with spinal cord injury; to investigate the relationship between sleep and spinal cord level, ambulation status, spasticity, quality of life, daily living activities, depressive status, neuropathic pain eighty patients with inpatient rehabilitation of spinal cord injury were included in the study. demographic characteristics, duration of spinal cord injury, spinal cord injury level, etiology, number of intermittent bladder catheterization (ic), number of night time ic, what time they slept, whether they woke up at night, classification of spinal cord injury were recorded. ambulation level with functional ambulation classification (fac), spasticity with modified ashworth scale (mas), depressive symptoms with beck depression index (bdi), quality of life with short-form health survey (sf-36), sleep quality the pittsburgh sleep quality index (psqi), daytime sleepiness epworth sleepiness scale (ess), activity of daily living with barthel index (bi), neuropathic pain were evaluated with the douleur neuropathique 4 questionnaire (dn4) scale.

Eligibility criteria:
inclusion criteria: * 18-65 years of age exclusion criteria: * noncooperativity * traumatic brain injury or other cerebellar-related neurological disease such as hemiplegia. * patients with spinal shock

Keywords: sleep quality
a study to assess pharmacokinetics of preladenant in participants with chronic hepatic impairment (p06513)

Conditions: Chronic Hepatic Impairment

Summary: the purpose of this study is to compare the pharmacokinetics (pk) of preladenant after administration of a single 5 mg oral dose of preladenant in participants with hepatic impairment and healthy volunteers. part 1 of this study compares healthy volunteers with participants with mild hepatic impairment. part 2 compares healthy volunteers with participants with moderate hepatic impairment. healthy volunteers in each part of this study are to be matched with participants with hepatic impairment by race, age, gender, and body mass index (bmi). the primary hypotheses are that in participants with mild or moderate hi, the area under the concentration-time curve from time 0 extrapolated to time of the last quantifiable concentration (auc0-t) of preladenant is similar to that observed in matched healthy volunteers, so that the mean ratio of hepatic impaired/healthy is contained within the interval \[0.50, 2.00\].


Eligibility criteria:
key inclusion criteria for healthy participants groups: * must be healthy with normal hepatic function and be free of any clinically significant disease or condition that requires a physician's care and/or would interfere with study evaluations or procedures. key inclusion criteria for hepatic impaired groups: * must have mild or moderate hepatic impairment. * must have a diagnosis of chronic liver disease for \>6 months. * clinical laboratory tests, physical examination, and electrocardiographs must be clinically acceptable to the investigator and sponsor. * must be free, other than chronic liver disease, of significant medical conditions unrelated to their hepatic disorder except for conditions that in the opinion of the investigator may not interfere with the study evaluations, procedures or participation. key exclusion criteria * must not be on any prohibited medications for entry into the trial.

Keywords: parkinson disease
surgeon experience restor a +4 intraocular lens (iol)

Conditions: Cataract

Summary: to collect visual outcome data post acrysof restor aspheric +4 implantation from surgeons throughout the united states.


Eligibility criteria:
inclusion criteria: * operable cataracts; candidate for presbyopic correcting intraocular lens (iol) exclusion criteria: * ocular comorbidities confounding study outcomes

Keywords: restor aspheric +4 iol
letrozole alone protocol versus using letrozole and hcg protocol

Conditions: PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Summary: letrozole is a chemical compound, cgs 20267 which is a third-generation, nonsteroidal aromatase inhibitor. letrozole blocks estrogen synthesis by directly affecting the hypothalamic-pituitary-ovarian axis, subsequently, increases gonadotropins which increase pregnancy rates. possible positive outcomes of aromatase inhibitors over selective estrogen-receptor modulators include a more physiologic hormonal stimulation of the endometrium which increases receptivity, a lower multiple-pregnancy through single follicle growth, a lesser side-effect especially vasomotor and mood symptoms, and more prompt clearance from blood, hence, reducing the probabilities of periconceptional exposure

the first pilot study for the clinical use of letrozole for ovarian induction in polycystic ovary syndrome (pcos) patients was done in 2000. in large randomized study, letrozole was superior to clomiphene as a treatment for anovulatory infertility in women with the polycystic ovary syndrome. letrozole was also associated with higher live-birth and ovulation rates. ovulation induction with letrozole is associated with an ovulation rate of 70%-84% and a pregnancy rate of 20%-27% per cycle. while in another study which compare the effect of letrozole alone with letrozole plus n-acetylcysteine on pregnancy rate in patients with polycystic ovarian syndrome, the pregnancy rate was 7.5% in letrozole alone group . human chorionic gonadotropin (hcg) hormone will replace the naturally surging luteinizing hormone at mid-cycle, subsequently, will lead to full maturation of oocytes resulting in ovulation. additionally, hcg will also enhance the endometrial quality by stimulating the corpus luteum. hcg is a hormone that is produced mainly by the placental syncytiotrophoblasts cells, it is also produced by other organs in minute amounts (liver, colon and pituitary gland). hcg main function is maintaining pregnancy through stimulating the corpus luteum to produce progesterone. this hormone is the cornerstone drug for inducing final maturation of follicles during a diversity of infertility treatment protocols. in order to diagnose polycystic ovarian syndrome two out of three rotterdam criteria should be present. these criteria are: chronic anovulation, clinical and/or biochemical evidence of hyperandrogenism, and polycystic ovaries by ultrasound . incidence of pcos from 6% to 21% when the eshre/asrm 2003 criteria were applied. infertility (clinical definition) is currently defined as 1 year of unwanted non-conception with unprotected intercourse in the fertile phase of the menstrual cycles

Eligibility criteria:
inclusion criteria: * infertile women with pcos * normal hysterosalpingography * normal semen analysis according to who parameters are major prerequisites exclusion criteria: * infertile women with causes other than pcos, * ages \ 35 years * women taken confounding medications like other infertility drugs * insulin sensitizers or hormones * abnormal hysterosalpingography * subnormal semen analysis
an imaging trial of the distribution of topical gel in the human vagina: assessment of bare spots

Conditions: HIV Infections

Summary: this study will assess the distribution of a microbicidal gel in the vagina and confirm the presence of bare spots. mris will be done with and without the addition of the mri contrast gadolinium to the microbicide in order to determine whether the bare spots are an artifact of the mri technique.


Eligibility criteria:
inclusion criteria: * 18 -45 year old women * normal pap smear * not pregnant exclusion criteria: * abnormal pelvic exam * history of claustrophobia * allergy to product formulation * pregnant or breastfeeding

Keywords: hiv seronegativity hiv
a comparative efficacy and safety study of nexium delayed-release capsules (40mg qd and 20mg qd) versus ranitidine 150mg bid for the healing of nsaid-associated gastric ulcers when daily nsaid use is continued in subjects in the us only

Conditions: NSAID Associated Gastric Ulcers

Summary: nonsteroidal anti-inflammatory drugs (nsaids) are often associated with gastric ulcers. this study looks at the treatment of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the us only.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily nsaid treatment for at least 2 months. * a gastric ulcer \>= 5mm in diameter, but no ulcer \>25 mm at its greatest diameter, at the baseline endoscopy. * other key inclusion criteria, as specified in the protocol. exclusion criteria: * history of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer. * history of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. * many other conditions and criteria, as specified in the protocol.

Keywords: nsaid nexium esomeprazole gastric ulcers
spiration ibv® valve system and spiration airway sizing kit

Conditions: Management of BPF (Bronchopleural Fistulae)

Summary: this procedure allows patients to use the humanitarian use device, ibv® valve system.

ibv® valve system the spiration® ibv valve system is a device to control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). an air leak present on postoperative day 7 is considered prolonged unless present only during forced exhalation or cough. an air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise. ibv valve system use is limited to 6 weeks per prolonged air leak.

Eligibility criteria:
inclusion criteria: * unresolved bpf * not candidate for surgical repair

Keywords: bpf(bronchopleural fistulae)
syl040012, treatment for open angle glaucoma

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: the purpose of this double-masked, randomized, controlled study is to assess the safety and ocular hypotensive efficacy of four different doses of syl040012 (bamosiran) eye drops compared to timolol maleate 0.5% after 28 treatment days in patients with elevated intraocular pressure.


Eligibility criteria:
inclusion criteria: * patients older than 18 years of either sex * good or fair general health as assessed by the investigator. * signed informed consent prior to any clinical trial-related procedures * diagnosis of open angle glaucoma (oag) or ocular hypertension (oht) * post-washout mean iop above target range * bcva 1.0 logmar or better by etdrs in each eye (equivalent to 20/200) * stable visual field * central corneal thickness 480-620 μm * shaffer gonioscopic grade of ≥ 3 (in at least 3 quadrants) in both eyes exclusion criteria: * pregnant or breastfeeding females * females of childbearing potential not willing to use a medically acceptable contraceptive method * clinically significant systemic disease * changes of systemic medication that could have a substantial effect on iop * known hypersensitivity to any component of the formulations * unable to comply with the clinical trial requirements * clinically significant abnormalities in laboratory tests * severe visual field defect * any secondary glaucoma * pseudoexfoliation or pigment dispersion component, history of angle closure or narrow angles. * iop ≥ 35 mm hg in any eye * previous non-laser glaucoma surgery or glaucoma laser procedures (e.g., laser trabeculoplasty) and refractive surgery * any ocular surgery or laser treatment, cataract extraction or ocular trauma within 6 months prior to baseline * evidence of ocular infection, inflammation, clinically significant blepharitis or conjunctivitis at baseline (visit 0), or a history of herpes simplex keratitis * clinically significant ocular disease

Keywords: syl040012 bamosiran sirna rnai glaucoma ocular hypertension
clinical pharmacy guided patient counselling and adherence support on renal transplant recipients

Conditions: Transplant;Failure,Kidney

Summary: as a result of the shortage of donor organs and the close relationship between allograft or even life loss and non-adherence after kidney transplantation, improvement of patient adherence appears essential. so the current study aimed to monitor adherence barriers of renal transplant recipients and evaluate possible consequences of nonadherence on recipients' clinical outcomes as well as to implement a structured adherence management program consisting of intensified patient counselling and adherence support by a dedicated clinical pharmacist as an adjunct to standard post-transplant patient education carried out by transplant physicians to investigate the efficacy of the implemented program on patients adherence and health outcomes as compared to standard physician patient care. the study is a prospective self-controlled interventional study that recruited 69 living donors-renal transplant patients attending the transplant clinic of nasser institute and satisfying the inclusion criteria. on enrolment, patient-related baseline data that could determine and affect patients' adherence as well as patients' clinical outcomes were recorded. after all patients received the adjuvant adherence management program by the clinical pharmacist for 6 month, patients' health outcomes were re-evaluated to compare them to baseline data


Eligibility criteria:
inclusion criteria: \>18 years at least 1 year post-transplant to allow for stabilization of the prescribed immunosuppressant therapy (ist) regimen independent of others for medication management and willing as well as able to repetitively visit the outpatient clinic for educational training \& data collection. exclusion criteria: * pediatric older than 65 years. multi-organ transplant. pregnant or lactating. cancer patients.
deep-learning for automatic polyp detection during colonoscopy

Conditions: Screening Colonoscopy

Summary: the primary objective of this study is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine whether a combination of colonoscopy and an automatic polyp detection software is a feasible way to increase adenoma detection rate compared to standard colonoscopy.


Eligibility criteria:
inclusion criteria: * patients presenting for routine colonoscopy for screening and/or surveillance purposes. * ability to provide written, informed consent and understand the responsibilities of trial participation exclusion criteria: * people with diminished cognitive capacity. * the subject is pregnant or planning a pregnancy during the study period. * patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active gi bleed) * patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation) * patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation). * patients with inflammatory bowel disease * patients with any polypoid/ulcerated lesion \> 20mm concerning for invasive cancer on endoscopy.
the influence of seat height on hemiplegic-pattern propulsion of manual wheelchairs

Conditions: Wheelchairs; Hemiplegia

Summary: this study evaluates the effect of seat height on hemiplegic-pattern wheelchair propulsion. each subject will act as their own control and measures will be obtained in a one sixty minute session. five seat heights relative to the subject's leg length will be measured in a random order to see the effect on forward and backwards wheelchair propulsion.

many people who have suffered a stroke require a wheelchair for mobility. hemiplegia is a common result of stroke.many people with hemiplegia propel themselves using their sound-side arms and legs ("hemiplegic-pattern propulsion") in manual wheelchairs.often people using this pattern are prescribed wheelchairs with a reduced seat height to facilitate foot propulsion. despite the seeming obviousness of the need to lower the seat height for people who use foot propulsion,there is little available evidence to help establish optimal wheelchair seat height. the study objective is to test the hypothesis that there is an optimum wheelchair seat height (expressed as a percentage of the lower leg length) for hemiplegic-pattern wheelchair propulsion. the investigators expect that the optimum seat height will be lower than that usually used for wheelchairs that are hand-propelled. a single-subject design with able-bodied participants will be used to investigate 5 randomized seat heights. the 5 seat heights will be set relative to the subjects leg length at a single 60 minute data collection session all measures will be obtained during one session. the optimal seat height will be chosen based on wheelchair propulsion speed, push frequency and effectiveness over 10m going forward on smooth surface, and 5m going backwards over a soft surface.

Eligibility criteria:
inclusion criteria: * willing to participate * is right-hand dominant (to simplify wheelchair and laboratory set-up) * has a subjective unshod height of ≤ 183 cm (6'0") * is able to be comfortably seated in the manual wheelchair used for the study * is 18 years of age or older, is alert and cooperative * is competent to provide informed consent * is able to communicate in english * does not have an unstable medical condition exclusion criteria: -
evaluating the efficacy and safety of fluticasone furoate inhalation powder in the treatment of asthma in adults and adolescents

Conditions: Asthma

Summary: a randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of fluticasone furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.

this is a multi-center, randomized, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of fluticasone furoate inhalation powder 100mcg once daily and fluticasone propionate inhalation powder 250mcg twice daily with placebo. subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). the primary endpoint consists of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) fev1 at the end of the 24 week treatment period. the nominated powered secondary endpoint is the change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period. safety assessments include adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion. for subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.

Eligibility criteria:
inclusion criteria: * signed informed consent * outpatient at least 12 years of age * both genders; females of child bearing potential must be willing to use approved birth control method * pre-bronchodilator fev1 of 40-90% predicted * reversibility fev1 of at least 12% and 200mls * current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks prior to first visit exclusion criteria: * history of life threatening asthma * respiratory infection or candidiasis * asthma exacerbation within 6 months prior to first visit * concurrent respiratory disease or other disease that would confound study participation or affect subject safety * allergies to study drugs, study drug excipients, medications related to study drugs * taking another investigational medication or medication prohibited for use during this study

Keywords: fluticasone propionate fluticasone furoate