Kornimate/medical-research-clean huggingface dataset:
classic yin and yang tonic formula for osteopenia

Conditions: Osteopenia

Summary: the purpose of this study is to evaluate the efficacy and safety of the classic yin and yang tonic formula for osteopenia and to research the mechanism of efficacy.

osteoporosis is a growing problem worldwide, with the greatest burden resulting from fractures. nevertheless, the majority of fractures in adults occur in those with "osteopenia" (bone mineral density (bmd) only moderately lower than young normal individuals) since life long drug therapy is an expensive option with uncertain consequences and side effect, natural herbal therapy offers an attractive alternative. the classic yin and yang tonic formula (eg.zuogui pill, yougui pill) have been used for osteoporosis or osteopenia in traditional chinese medicine(tcm) for a long time. for this reason, chinese guidelines for the treatment of osteopenia include natural herbal therapy, however, there is currently no randomize placebo controlled trial to verify the efficacy for treating low bmd. this trial is randomized, double blind, placebo controlled design. results of this study will provide evidence regarding the value of the classic yin and yang tonic formula as an intervention for increase bmd and decreasing fracture risk in osteopenia. furthermore, the mechanisms of action can be identified by this study.

Eligibility criteria:
inclusion criteria: * bmd t-scores of the hip (femoral neck or trochanter)and/or spine between -1.0 and -2.5; * pattern differentiation is kidney deficiency in tcm. * informed consent. exclusion criteria: * osteoporotic (t-score\< -2.5) at any site or a fracture in the past 2 years not caused by motor vehicle accident; * prior or current use of medication that increase risks of fracture (e.g. steroids, anti-convulsants, anticoagulants,lithium); * prior or current use of medications that modify bone metabolism (e.g. bisphosphonates, selective estrogen receptor modulators such as raloxifene); * use of calcium supplements above levels suggested within the recommendations of standard care (i.e., above 1200-1500 mg); * current or prior year use of estrogen or calcitonin; * malignancies other than skin cancer; * conditions that cause secondary osteoporosis (e.g. cushing's syndrome, marfan's syndrome); * lactation and gestational period; * physical or mental disabilities that will preclude informed consent or active study participation; * supersensitivity body constitution. * osteoporotic fracture of having operating indication.

Keywords: osteopenia,chinese herb
community-based nutrition-lifestyle therapy for pregnant latina women with diabetes

Conditions: Diabetes Mellitus, Type 2; Diabetes Mel Gestational - in Pregnancy

Summary: socioeconomically disadvantaged (sed) pregnant latina women are disproportionately burdened by type 2 diabetes (t2d). although lifestyle interventions can help to improve diabetes control, there are barriers to sed, spanish-speaking pregnant people participating. the purpose of this proposal is to develop and test a culturally tailored, dietary-lifestyle behavioral intervention that supports eating plant-based foods such as fruits, vegetables, nuts and grains instead of processed foods and meat, and is implemented through community health workers (chws) to prevent excessive weight gain during pregnancy and improve control of blood sugar levels in pregnant latina women with t2d. this study takes advantage of our existing strong relationships with the local latino community, chws, and santa barbara county public health, which includes eight multidisciplinary healthcare clinics with sliding fee programs, and rooted santa barbara, a community plant-based lifestyle organization. cultural sensitivity focuses on delivering health information based on norms, values, beliefs, environmental factors, and historical context that is unique to a racial/ethnic population. therefore, for our program to be culturally sensitive, it will include delivery of the program by chws primarily in the spanish language with english as needed and incorporation of culturally relevant eating and physical activity recommendations. the specific aims of the project are: 1) in year one, develop the dietary-lifestyle behavioral intervention that encourages a plant-forward diet for pregnant latina women with t2d to prevent excessive weight gain during pregnancy and improve blood sugar control in collaboration with chws and participants by conducting focus groups to incorporate feedback on the program; 2) initiate in year one, and in year two, conduct a randomized controlled trial with 30 pregnant latina women with t2d to evaluate the how well the nutrition-behavior lifestyle program works; and 3) evaluate the acceptance and delivery of the dietary-lifestyle behavioral intervention in chws and participants. if successful, this study will establish the how well a culturally sensitive program delivered by chws incorporating plant-forward diets for pregnant latina women with t2d prevents excessive weight gain during pregnancy, and control of blood sugar levels.


Eligibility criteria:
inclusion criteria: * diabetes in pregnancy * ≥ 18 years old * self-reported hispanic and/or latino/a heritage * bmi ≥ 26.0 kg/m2 and ≤ 42.0 kg/m2 exclusion criteria: * type 1 diabetes * active substance abuse with alcohol or drugs by self-report * treatment with non-diabetes medications (e.g., corticosteroids, anti-psychotics) known to have metabolic/body weight effects that could affect outcome measures * non-singleton fetus * evidence of fetal malformation * hba1c ≥ 10% * unable to provide informed consent or unwilling to complete the study
pediatric nmosd observational study

Conditions: Neuromyelitis Optica; NMO Spectrum Disorder

Summary: this study is being done to develop a database of pediatric patients in order to study the cause, early detection and best treatment for neuromyelitis optica spectrum disorder (nmosd) in pediatric patients.

this study is being done to collect information on the natural history of nmosd in pediatric aqp4-igg seropositive patients. a major restriction in performing drug studies in pediatric patients with nmosd is limited information on the course of the disease in these patients. collecting clinical information over the course of a 1 year observational study would inform on the natural history of the disease in these patients. a repository of pediatric patients with rare diseases can increase knowledge on the natural history of the specific disease, assist in identifying appropriate patients fulfilling specified criteria for drug studies and potentially serve as a control group. timepoints: baseline, 3mo, 6mo, 9mo, 12mo (+/- 1 mo for each time point). baseline data: * demographics \[age/sex/ethnicity\], * clinical presentation information including date of initial diagnosis, * clinical phenotype * immunotherapy used current and past, * family history of autoimmune diseases, * serological data results * radiologic data as available self-report assessments will be: * current impairment, as measured by the expanded disability status scale (edss) score self-reported using ratzker (1997) edss self report form, * quality of life as measured by the eq-5d and varni's (1998) pedsql over the phone/mail/email. at follow-up visits 3mo, 6mo, 9mo, 12mo (+/- 1 mo for each time point): * attacks/relapses * any hospitalizations * confirm medications and update records if changes self-report assessments at follow-up will be: * current impairment, as measured by the edss score self-reported using ratzker (1997) edss self report form, * quality of life as measured by the eq-5d and pedsql over the phone/mail/email.

Eligibility criteria:
inclusion criteria: * aqp4 positive * ability to give informed consent by patient or caregiver exclusion criteria: - inability to complete required forms via phone, mail, or email.

Keywords: pediatric aquaporin-4 aqp4 nmosd nmo neuromyelitis optica
a study of semorinemab in patients with moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this phase ii, multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the clinical efficacy, safety, pharmacokinetics, and pharmacodynamics of semorinemab in patients with moderate ad. the study consists of a screening period, a double-blind treatment period, an optional open-label extension (ole) period, and a safety follow-up period. there may be up to two study cohorts.


Eligibility criteria:
inclusion criteria: * national institute on aging/alzheimer's association core clinical criteria for probable ad dementia * evidence of the ad pathological process, by a positive amyloid assessment either on csf aβ1-42 as measured on elecsys β-amyloid(1-42) test system or amyloid pet scan * ad dementia of moderate severity, as defined by a screening mmse score of 16-21 points, inclusive, and a cdr-gs of 1 or 2 * availability of a person with sufficient contact with the participant to be able to provide accurate information on the participant's cognitive, behavioral and functional ability exclusion criteria: * pregnant or breastfeeding * inability to tolerate mri procedures or contraindication to mri * contraindication to pet imaging * residence in a skilled nursing facility * any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or bias the assessment of the clinical or mental status of the participant to a significant degree * any evidence of a condition other than ad that may affect cognition * substance abuse within the past 2 years * use of any experimental therapy within 90 days or 5 half-lives prior to screening, whichever is greater, or any passive immunotherapy against tau * use of any passive immunotherapy (immunoglobulin) against aβ, unless the last dose was at least 1 year prior to screening or any active immunotherapy (vaccine) that is under evaluation to prevent or postpone cognitive decline * any other biologic therapy or previous treatment with medications specifically intended to treat parkinsonian symptoms or any other non-ad neurodegenerative disorder within 1 year of screening * systemic immunosuppressive therapy within 12 months of screening through the entire study period * typical antipsychotic or neuroleptic medication within 6 months of screening * daily treatment with any of the following classes of medication (except for intermittent short-term use): opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally-acting antihistamine or anticholinergic activity * stimulant medications, unless the dose has been stable within the 6 months prior to screening and is expected to be stable throughout the study
osteoradionecrosis and pentoclo protocol: retrospective study

Conditions: Osteoradionecrosis of Jaw

Summary: osteoradionecrosis (orn) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. differents therapeutics exist but there is no consensus concerning the management of the maxillary orn. the understanding of new pathological mechanisms opens the way to new therapeutic perspectives.


Eligibility criteria:
inclusion criteria: * patient over 18 being or having been treated by pentoclo combination for an osteoradionecrosis of the jaw exclusion criteria: * tumoral recidivism * precocious stop of pentoclo
how does your genetic make-up (profile) influence your glaucoma?

Conditions: Primary Open Angle Glaucoma

Summary: glaucoma is a group of diseases in which visual loss occurs because of damage to the optic nerve. research has shown that certain genes may cause glaucoma in some cases. so far, research has only been able to find the genes responsible for glaucoma in a small percentage of people who have glaucoma. the purpose of this project is to study the genes in patients with and without glaucoma to find additional genes that may be responsible for causing glaucoma.

four tubes of blood will be taken from 100 people. of those, half will have primary open angle glaucoma (poag) and the other half will be controls (normals), half will be caucasians and the other half will be african americans, half male and half female. all groups will have a routine ophthalmic eye exam, color vision, snellen vision, and visual field done.

Eligibility criteria:
inclusion criteria: * 40 yrs * caucasian or african american * male or female with poag, pacg, pxfg, * normal exclusion criteria: * other ophthamic co-morbidities * other ethnic groups * unable to understand and give informed consent

Keywords: primary open angle glaucoma nuclear genetics mitochondrial dna poag
single centre study to compare harmonic scalpel to conventional diathermy in free tissue transfer breast reconstruction

Conditions: Breast Reconstruction

Summary: the purpose of this single centre study is to evaluate whether the use of harmonic synergy dissecting hook (harmonic scalpel) in breast reconstruction surgery is superior to conventional diathermy in terms of improving ease and speed of perforator dissection, reducing postoperative pain, days of hospital stay and time taken to return to daily activities.


Eligibility criteria:
inclusion criteria: 1. female patients aged between 18 and 80 years old 2. able to comprehend, follow, and provide written informed consent. 3. willingness to comply with study requirements including follow-up visits exclusion criteria: 1. patients who have a pacemaker 2. pregnant or breast feeding females. 3. general contraindication for surgery as deemed by the pi (e.g. physically unfit) 4. patients who smoke 5. diabetic patients 6. patients who are receiving permanent analgesics 7. patients receiving anti-coagulation therapy. 8. patients with a physical or psychological condition which would impair participation in the study. 9. participation in any other device or drug study within 90 days prior to enrollment. 10. planned participation in any other medical device study during the timeframe of this study.

Keywords: breast reconstruction halmonic scalpel diathermy free tissue transfer
a randomised, controlled study of bimesh, pelvicol for vaginal wall prolapse

Conditions: Vaginal Prolapse

Summary: anterior vaginal wall prolapse is a common problem. until now many different surgical techniques have been evaluated but so far recurrence is often still observed. therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced.

anterior vaginal wall prolapse is a common problem. until now many different surgical techniques have been evaluated but so far recurrence is often still observed. therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced. however, is is now known whether these methods are superior to the replication of the pubocervicale fascia, a method which is well described and have been used for many years. furthermore, most studies evaluating the used of mesh for anterior vaginal wall prolapse have not been controlled studies and been irrespective to whether the repair was a primary or secondary operation.

Eligibility criteria:
inclusion criteria: * anterior vaginal wall prolapse greater than grade 2 ics qualifications, international continence society committee for standardisation of terminology exclusion criteria: * recurrent vaginal prolapse, wault prolapse

Keywords: anterior vaginal wall prolapse, pelvicol, biomesh anterior vaginal wall prolapse
patient perspectives in squamous cell carcinoma clinical trials

Conditions: Squamous Cell Carcinoma

Summary: clinical research participation has historically been heavily biased toward specific demographics. this study will invite several participants to gather a wide range of information on clinical trial experiences for squamous cell carcinoma patients. the aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of squamous cell carcinoma. people with squamous cell carcinoma who are invited to take part in clinical research will benefit from the analysis of the data.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years old * confirmed diagnosis of squamous cell carcinoma * subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination. exclusion criteria: * inability to provide written informed consent * is pregnant, breastfeeding or expecting to conceive within the projected duration of the study * enrolled in another research study

Keywords: squamous cell carcinoma
short-term effects of connective tissue massage after hysterectomy

Conditions: Massage; Hysterectomy; Pain

Summary: the aim of this study to investigate the effects of connective tissue massage (ctm) on pain, intestinal peristaltism and functionality after total laparoscopic (tlh) or abdominal hysterectomy (tah). patients who underwent tlh randomly group as tlh-ctm (n=15) and tlh control (n=16), and tah randomly group as tah-ctm (n=14) and tah control (n=15). the postoperative daily monitoring sheet, visual analogue scale (vas), time of intestinal peristaltism employees to collect research data.

interventions in the control groups (tlh control and tah control) only in-bed activities and walking recommendations will be given, and routine care (analgesics and wound care) applies. in addition, ctm applies in the ctm groups (tlh-ctm and tah-ctm). connective tissue manipulation: the patients are informed about ctm and its mechanism of action before starting the ctm application. ctm is performed by a trained physiotherapist as the patient was in a sitting position. all posterior connective tissue areas (sacral, lumbar, lower thoracic, scapular, inter-scapular, and cervical) are stimulated. both short and long strokes will use during the manipulation. each stroke will repeate three times, first on the right and then on the left of all desired zones. all sessions will terminated with long bilateral strokes to the iliac crest and subcostal regions. during manipulation, the pad of the middle finger will be in contact with the patient's skin. application will take approximately 30-35 minutes depending on the area treated. ctm will apply twice: at postoperative 3rd hour and after 24 hours. routine care and advising: in-bed activities will advice to the patients in both groups. in-bed activities are; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. in addition, hourly walking activities are recommended after the anesthetic effect wore off. vital signs (pulse rate, blood pressure, and respiratory rate) and body temperatures will evaluate regularly. the investigators, will determine the severity of severe pain with the vas scale. according to the vas scale, if the patient reports pain intensity between 7-10 out of 10, it means that she has severe pain. patients will encourage for early ambulation. initially, they walked 10-15 m inside their rooms and the amount of walking increased over time.

Eligibility criteria:
inclusion criteria: * volunteered to participate in the study, * those who underwent benign abdominal or laparoscopic hysterectomy, * who were stable at post-operative vital signs and those with no complications in the early postoperative period exclusion criteria: * they had oncological diseases, * chronic pain history, prolapse, * those who had previous abdominal surgery, * those with known psychological problems. for the ctm groups, * those with local infection (abscess etc.), open lesion/wound, scar tissue, edema, and hematoma in the lumbar region.
an open-label study of hydromorphone oral solution in subjects aged 28 days to 16 years for postoperative pain

Conditions: Postoperative Pain

Summary: the primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. the secondary objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.

hydromorphone is an opioid analgesic that has been used for decades as an alternative to morphine in the treatment of moderate to severe malignant and nonmalignant pain. only a small number of analgesics have been studied in children. the benefits to the subjects include contribution of knowledge that will provide for appropriate dosing regimen recommendations for future pediatric subjects. treatment consisted of both parenteral and oral hydromorphone. for up to 48 hours immediately following surgery, subjects were administered hydromorphone by iv pca pump. dosing with the oral hydromorphone hcl began when the subject was ready to take clear oral liquid. subjects were administered oral hydromorphone hcl every 6 hours for up to 9 doses. the investigator determined the timing of the first dose based on each subject's clinical condition. the duration of the treatment phase was up to 102 hours (up to 48 hours for the parenteral treatment period and up to 54 hours for the oral treatment period). efficacy was based on the oral hydromorphone treatment. adverse events were collected for both the oral and parenteral treatments.

Eligibility criteria:
inclusion criteria: * pediatric subjects aged 28 days to 16 years, * prospective subjects anticipated to have postoperative pain requiring oral opioid analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral analgesia (up to 48 hours), * prospective subjects have received no more than a total of 7 doses of opioids in the 30 days prior to surgery. exclusion criteria: * prospective subjects with clinically significant hepatic or renal dysfunction and impaired cardiac and/or respiratory reserve, * prospective subjects who have received opioid analgesic therapy other than hydromorphone or morphine sulfate during the up to 48-hour postoperative period prior to administration of first dose of oral hydromorphone, * prospective subjects who have received regional anesthetic blockade or analgesic treatment with nonopioid medication within 6 hours prior to administration of first dose of oral hydromorphone. other protocol-specific inclusion/exclusion criteria may apply.

Keywords: postoperative pain hydromorphone oral solution opioid pharmacokinetics pharmacodynamics
effect of pre-emptive assessment of self-care peritoneal dialysis (pd) ability on pd choice in patients with stage 5 chronic kidney disease

Conditions: Chronic Kidney Disease (CKD) Stage 5

Summary: peritoneal dialysis is an effective renal replacement therapy with higher quality of life and lower treatment cost than hemodialysis.however, the application rate of peritoneal dialysis is much lower than that of hemodialysis. one of the reasons is that patients need to complete fluid changing operation independently, which is especially challenging for elderly and frail patients. assisted peritoneal dialysis can help patients with independent dialysis disorders to complete dialysis. currently, there is a lack of standard tools to assess patients' ability to conduct independent dialysis and to determine whether assisted dialysis is needed. moreover, routine assessment is arranged after the training of dialysis operation, which leads to some patients giving up the procedure at an early stage, resulting in a low selection rate of the procedure.the purpose of this study was to investigate the effect of using a standard scale to evaluate the ability to perform abdominal dialysis in patients with stage 5 chronic kidney disease (ckd) before deciding on dialysis modality.


Eligibility criteria:
inclusion criteria: 1. age \>=18 years old; 2. need dialysis within 6 months; 3. informed consent. exclusion criteria: 1. absolute pd contraindications; 2. need urgent dialysis; 3. rtx as initial renal replacement therapy.