Kornimate/medical-research-clean huggingface dataset:
milk production and body weight response to suggested protocol in obese lactating women

Conditions: Breastfeeding

Summary: this study will investigate the milk production and body weight response of both mother and the newborn to aerobic exercise in obese lactating women.

breastfeeding is a normal method of providing nutrition to young infant by breast milk. breastfeeding is equally important and beneficial for not only infant but also for the mother. women with high bmi have delays in establishing lactation after giving birth. in addition, overweight and obesity increase the risk of early cessation of breastfeeding. aerobic exercises have positive effects on breastfeeding frequency and body weight of neonate and can increase blood flow to the chest which is effective in lactation performance. so, this study will help to evaluate the efficacy of aerobic exercise in addition to guidelines for breastfeeding, nutrition and fluid intake on milk production, baby and mother weight.

Eligibility criteria:
inclusion criteria: * multiparous obese mothers having number of parity ranges from two to four times. * lactating mothers within 2nd month after delivery. * all of them diagnosed by gynecologist as having insufficient lactation * age will range from 25-35 years old. * body mass index: 30-40 kg/m². exclusion criteria: * lactating women suffering from postpartum hemorrhage * poor mammary development * cardio respiratory disease * diabetes mellitus * breast cancer * getting pregnant again during breast feeding period * mental disorders * previous surgeries in the chest, breast or the surrounding area * anemia * having twins or causes that hindering normal breast feeding as (mastitis, retracted, cracked, inflamed or inverted nipple)
safety and efficacy of cold laser plaque ablation for lower limb arterial stenosis and occlusive lesions

Conditions: Arterial Disease of Legs; Atherosclerosis of Artery

Summary: this study is a prospective, multi-center, randomized controlled study, which evaluates the effectiveness and safety of cold laser plaque ablation for lower limb arterial stenosis and occlusive lesions from intermittent claudication to chronic threatening limb ischemia.

this study is a prospective, multi-center, randomized controlled study. this study will be conducted at four centers and is expected to enroll 110 patients. and we will evaluate the effectiveness and safety of cold laser plaque ablation compared to excimer laser system for lower limb arterial stenosis and occlusive lesions.

Eligibility criteria:
inclusion criteria: general selection criteria 1. age between 18 and 85, gender is not limited; 2. patients with symptomatic lower extremity arteriosclerosis disease (lead), rutherford grade 2 to 5; 3. the stenosis of lower extremity arteries is greater than 70% or occlusion; 4. the subject is able and willing to comply with all requirements, including 6-month follow-up and evaluation, voluntary participation and informed consent. intraoperative contrast inclusion criteria 1. the internal diameter of the reference vessel proximal to the target lesion is greater than 1.8mm; 2. the stenosis of target lesion is greater than 70%; exclusion criteria: 1. the target lesion is located in the artificial vascular or autologous venous vascular bypass; 2. endovascular or surgical procedure in the target limb performed less than or equal to 30 days prior to the index procedure or planned endovascular or surgical procedure 30 days after the index procedure; 3. intent to use other atherectomy device in the same procedure; 4. flow-limiting dissection within, proximal or distal to the target lesion; 5. evidence or history of aneurysm in the target vessel， intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months; 6. uncorrected coagulation abnormalities (platelet count ≤ 75\*109/ l or inr≥2.0), bleeding constitution, and history of heparin-induced thrombocytopenia (hit); 7. any thrombolytic therapy was performed within 2 weeks before surgery; 8. history of severe trauma, fracture, major surgery, or parenchymal organ biopsy within 2 weeks before surgery; 9. known allergy to contrast agents or perioperative drugs; 10. anticoagulation, antiplatelet or thrombolytic therapy is prohibited; 11. pregnant or lactating women; 12. subjects participating in other clinical trials of drugs or medical devices; 13. other circumstances assessed by the investigator as inappropriate to participate in the trial.

Keywords: cold laser plaque ablation lower limb arterial stenosis occlusive lesions atherectomy
intraoperative detection of lesions using pet (positron emission tomography) probe during secondary cytoreductive surgery for recurrent ovarian, fallopian tube and primary peritoneal cancer

Conditions: Ovarian Cancer; Fallopian Tube; Primary Peritoneal

Summary: the purpose of this study is to see if positron emission tomography (pet) probes make it easier for your surgeon to find cancer and remove it during your surgery. a pet probe is a wandlike device that can detect radioactivity.


Eligibility criteria:
inclusion criteria: * pathologically proven diagnosis of ovarian carcinoma, fallopian tube, or primary peritoneal not to include tumors of low malignant potential (all stage, grade, and histology) * first recurrence * platinum sensitive as defined by disease free interval ≥ 6 months * radiological evidence of recurrent disease on preoperative pet/diagnostic ct * planned surgical secondary cytoreduction via laparotomy * \>18 years old exclusion criteria: * secondary cytoreduction via laparoscopy or robotically assisted laparoscopy * tumors of low malignant potential * beyond first recurrence * with the exception of non-melanoma skin cancer, subjects with other invasive malignancies, who had (or have) any evidence of the other cancer present within the last 5 years, are excluded * active infection requiring parenteral antibiotics * for subjects with diabetes mellitus, a blood sugar will be checked preoperatively and must be \<200 for participation in the study

Keywords: pet (positron emission tomography) 18f-fdg cytoreductive surgery 13-017
effect of no drainage tube on blood loss and recovery after high tibial osteotomy

Conditions: Osteoarthritis, Knee

Summary: the objective of this study was to evaluate the safety and efficacy of topical combined with intravenous tranexamic acid for high tibial osteotomy without placement of a drainage tube the clinical scores of patients and their possible risks were tracked. the investigators hypothesized that a combination of tranexamic acid and no drainage tube could reduce blood loss and facilitate early recovery. the implementation of the study will provide a new perioperative blood loss control program for high tibial osteotomy, reduce the cost of hospitalization, promote patients to get out of bed early, reduce the number of days in hospital.

the condition of the patients was evaluated, and the total length of both lower limbs, anteroposterior position of knee and mri of knee were included. the preoperative dose of tranexamic acid was calculated according to body weight of 20 mg / kg, 100 ml of tranexamic acid sodium chloride solution was dripped 30 minutes before operation, and after incision closure, 30 ml of normal saline solution containing 2 g of tranexamic acid was injected through drainage tube or subcutaneously. postoperative intravenous drip of 100 ml sodium chloride solution containing 20 mg / kg tranexamic acid. arthroscopy was first used to further confirm the cartilage defect, and a new type of lower limb alignment meter and a customized precise osteotomy template were used to perform the osteotomy according to the preoperative plan. one group was not placed drainage tube, the other group was placed drainage tube. visual analogue pain score (vas) and american special surgical hospital (hss) knee function score were recorded 3 month after surgery. throughout the trial, the investigators will carefully observe and manage your complications and the outcome of your surgery.

Eligibility criteria:
inclusion criteria: 1. simple knee medial compartment osteoarthritis high tibial osteotomy. 2. with varus deformity, medial proximal tibia angle \<85° 3. unilateral high tibial osteotomy 4. informed consent: participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process exclusion criteria: 1. patients who underwent other knee surgery within 6 months 2. preoperative combined anemia (hb\<100g/l) 3. patients with severe cardiovascular, hepatic, renal and hematopoietic diseases 4. patient with preoperative coagulation abnormalities 5. patients with allergies and patients allergic to txa.
gene mutation spectrum of malignant hyperthermia in china

Conditions: Malignant Hyperthermia

Summary: in this study, case information and specimens of patients with malignant hyperthermia(mh) will be collected from all over china, and gene fragment analysis, sanger sequencing method and/or high-throughput whole-genome sequencing will be performed. the mh bioinformatics database will be established to find the pathogenic gene and mutation site of mh in chinese. based on the bioinformatics database, the genetic law of mh family will be studied. according to the results of the study, the guideline for the diagnosis and treatment of mh that is in line with chinese population biology characteristics will be formulated.

when mh cases or suspected cases occur in china, anesthesiologists can seek help through malignant hyperthermia emergency rescue wechat group in which experts from all over the country will give therapy instructions. afterwards, the responsible anesthesiologist will complete the case report form (crf) and collect family history of mh. the quality of crf is reviewed by the investigator and all the queries are solved within 1\~2 weeks. upon obtaining the informed consent, all biological specimens of mh confirmed or suspected patients and their blood relations will be collected in the local hospitals and transported to west china hospital, sichuan university in dry ice packaging. all specimens will be checked by the trained investigator, registered and labeled in a standardized manner, and then stored in the biological sample bank of west china hospital, sichuan university. firstly, investigators will use the method of gene fragment analysis to detect the samples at the diagnostic mutation sites included in the current european malignant hyperthermia group. secondly, investigators will use sanger sequencing method to verify the mutation variants. if the screening results are negative, then high-throughput whole-genome sequencing will be performed. the mh bioinformatics database will be established to find the pathogenic gene and mutation site of mh in chinese. based on the bioinformatics database, the genetic law of mh family will be studied. according to the results of the study, the guideline for the diagnosis and treatment of mh that is in line with chinese population biology characteristics will be formulated.

Eligibility criteria:
inclusion criteria: * chinese whose malignant hyperthermia susceptibility had been confirmed after a positive clinical manifestation of malignant hyperthermia which defined as their scores of clinical grading scale for malignant hyperthermia are more than 35 and their blood relations. * sign informed consent exclusion criteria: * patients who have no adverse anaesthetic event, such as those patients referred with a history of exertional heat illness, exertional or recurrent rhabdomyolysis, or a congenital myopathy.

Keywords: malignant hyperthermia gene mutation spectrum bioinformatics database
restore trial: a phase 2 study evaluating the efficacy and safety of pemvidutide in the treatment of alcohol-associated liver disease (ald)

Conditions: Alcohol Liver Disease

Summary: this is a phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ald. * pemvidutide: 2.4 mg sc once weekly * placebo: placebo sc once weekly


Eligibility criteria:
inclusion criteria: 1. male or female ages 18 to 75 years, inclusive 2. overweight or obesity, defined as bmi ≥ 25 kg/m2 3. history of alcohol misuse for the prior 3 years, with an alcohol intake ≥ 50 grams per day for males and ≥ 40 grams per day for females on average in the past year 4. liver stiffness of 10.0-18.5 kpa by vcte, inclusive exclusion criteria: 1. presence of clinically significant alcohol withdrawal symptoms, defined as ciwa-ar score ≥ 10 at screening and/or prior to randomization 2. history of hospitalization for alcohol intoxication or alcohol withdrawal within the past year 3. history of seizures related to alcohol within the past year 4. history and/or current dsm-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder, or another severe psychiatric disorder, unless documented as well-controlled by the investigator for at least 6 months prior to screening and cleared by the medical monitor
factors affecting early progress of cochlear implant outcomes in adults

Conditions: Sensorineural Hearing Loss, Bilateral

Summary: the aim of this study is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition score in adults using currently a nucleus cochlear implant.


Eligibility criteria:
inclusion criteria: * adult subjects, 18 years or older * subjects unilaterally implanted or bilaterally implanted with at least 6 months separating the two cochlear implantations. * subjects who have been implanted between january 2016 and december 2021. * subjects have received a nucleus ci: ci512, ci522 or ci532 cochlear implants with non-rotating magnet, or ci600 series equivalent ci612, ci622 and ci632 with rotating magnet and external sound processors cp900 or cp1000 behind-the-ear, or kanso or kanso 2 off-the-ear types. * subjects who are fluent in french (language used in the questionnaire and speech tests) * subjects who are not opposed to participating in the study * subjects for who the medical record data is available throughout the defined data search period. exclusion criteria: * subjects with single-sided deafness (ssd). * subjects who are not affiliated to the french social security. * subjects who are under legal protection.

Keywords: cochlear implant sentence recognition cognitive processing electrophysiology
caelyx, cyclophosphamide and herceptin in patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: eligible patients must receive caelyx plus cyclophosphamide plus herceptin for 6 cycles that will be administered every 4 weeks.

sample size calculation will be done by means of simon's method in 2 stages for phase ii studies and will be based on the principal aim of the study (evaluation of the rate of objective response). the hypothesis brings over of the efficiency of the treatment it will be accepted if a rate of objective response of at least 55 % is obtained, rejecting the efficiency of the treatment when the rate of response targets be lower than 35 %. in this case, considering an alpha error of 0.05 and 80 % power, 14 patients will be included in the first stage; the study would continue if more than 5 objective responses were found. the total number of patients to including in the study would be 44. the results will be significant if they find at least 20 objective responses. assuming a drop-out rate of 10 %, the total number of patients needed is 49 patients.

Eligibility criteria:
inclusion criteria: * patients must sign an informed consent before of specific procedures of clinical trial. * patients with histologically confirmed breast cancer and overexpression of her2neu. * age\> 18 years. * eastern cooperative oncology group (ecog) equal or \< 2. * patients have not been treated previously with chemotherapy for metastatic disease. * patients must have at least one measurable lesion according to recist criteria. * patients should have an adequate organ function to tolerate chemotherapy. exclusion criteria: * patients with hypersensitivity reactions to any of the medications of the clinical trial. * patients who are pregnant or lactating are not eligible. * hepatic disease. * not controlled active infection * symptomatic metastatic brain cancer * previous adjuvant treatment with anthracyclines with a total accumulated dose \> 300 mg/m2 (doxorubicin) or \> 600 mg/m2 (epirubicin)

Keywords: her2 positive breast cancer metastatic breast cancer
prevalence of covid-19 antibodies kingman az

Conditions: Covid19

Summary: the covid-19 disease outbreak is a historic event that has challenged medical systems in the united states. currently, most reports of confirmed cases rely on the testing of symptomatic patients. these estimates of confirmed cases miss individuals who have recovered from infection, with mild or no symptoms, and individuals with symptoms who have not been tested due to the limited availability of tests. we are conducting serology testing within the community for sars-cov-2-specific antibodies through a serologic test could give insight into past covid-19 infections within our community.

adult participants aged 18 or greater will be recruited from the greater kingman az area through social media, radio, newspaper, and a press release. participants self-selected inclusion in the study by calling into a covid-19 hotline and will be included in the sample data following self-report of absence of covid-19 symptoms. participants will be scheduled for testing on the weeks of 09/28/2020 and 10/05/2020. upon recruitment, participants will be asked to complete a demographic and behavioral survey, assessing socioeconomic status, interpersonal interactions, personal protective measures, and covid-19 symptomology in the preceding two months. two months after initial testing, all negative sars-cov-2-specific antibodies participants will be contacted for repeat testing and surveying. sars-cov-2-specific antibodies will be tested using a lateral flow immunoassay with the vitros anti-sars-cov-2 igg test (ortho-clinical diagnostics, inc.) under the emergency use authorization (eua) from the food and drug administration (fda). the diagnostic sensitivity of the immunoassay was 87.5% and specificity was 100%. the positive and negative predictive value with a prevalence of 5% in the community was 100% and 99.3% respectively. all data will be de-identified and stored in a password protected file only visible to study investigators. all positive results were called back to participants by the lead author. data obtained was then used to estimate the population prevalence of sars-cov-2-specific antibodies in the kingman, arizona population. unweighted and weighted proportions of positive tests were calculated to match the 2018 census on sex, race, education, and income. confidence intervals for unweighted data will be estimated using exact binomial models and for weighted and adjusted estimates using bootstrap methods. all data was analyzed using spss.

Eligibility criteria:
inclusion criteria: * adults aged 18+ * resident of mohave county az exclusion criteria: * children under 18yo * previous positive sars-cov2- antibody test * active symptoms of respiratory illness
intensive referral to al-anon: benefits to concerned others and their drinkers

Conditions: Alcohol Use Disorder

Summary: this study is examining the effectiveness of al-anon intensive referral (air) with concerned others (cos) of individuals in treatment for alcohol use disorders ("drinkers"). air's goal is to facilitate al-anon participation and positive outcomes among cos.

in a randomized controlled trial, this 4-year project is evaluating air's effectiveness for cos. cos and their drinkers are assessed at baseline and 3-month, 6-month, and 1-year follow-ups. hypotheses are that, compared to usual care, air will increase al-anon participation and improve co outcomes. we will examine hypotheses using generalized mixed-effects regression models (glmm). this project is built on the foundation that it is essential to help cos because of their own suffering.

Eligibility criteria:
inclusion criteria: 1. the drinker is an adult (≥19 years old) entering a treatment episode for the primary substance of alcohol; 2. the drinker signs a release for researchers to contact a co (also an adult) he or she identifies as a family member or close friend who has had contact with the drinker on at least 12 (40%) of the past 30 days; and 3. the drinker and co can communicate in english. - exclusion criteria: 1. the drinker is \<19 years old, not entering a treatment episode for alcohol use disorder; 2. the drinker does not sign a release for researchers to contact a co; 3. the drinker and co cannot communicate in english. -
comparison of glue with sutures for pterygium surgery

Conditions: Pterygium

Summary: pterygium excision surgery involves excising the abnormal growth from the cornea and filling the defect with a conjunctival (white of the eye) graft from the superior part of the eye. this is the best method of pterygium excision but it is recognised that in 10-15% of cases it will grow back (recurrence). currently the investigators use small sutures to sew the graft in place. recently it has been described that glue can be used instead of the sutures. it has been shown in one study that the patient discomfort is less and so is the surgical time. the investigators want to confirm these findings and also compare the recurrence rate between the two types of surgery. they plan to complete a prospective, randomised, control trial of 40 participants. twenty will have traditional pterygium surgery with the conjunctival autograft sutured. twenty will have cut and paste surgery with tisseel glue. the two groups of participants will be compared for pain and discomfort, surgery time, and recurrence rate of the pterygia.

this is a prospective, randomised, control trial of 40 participants. twenty patients in each arm. twenty patients undergo standard pterygium excision with the conjunctival autograft sutured. twenty patients undergo pterygium surgery with tisseel glue replacing sutures as a method of attaching the conjunctival autograft. participants will be reviewed, selected, and consented on a pre-assessment day. surgery will be performed 10 at a time on an all day surgery operating list. randomisation of the surgery type will be done at the time of surgery after the pterygium has been excised and the autograft taken. one surgeon (r. hall) will perform all of the procedures. follow-up will occur at week 1, 2, 4, 26, 52. a questionnaire answered by participants will indicate their pain, foreign body sensation, tearing, and discomfort. there will be observation of any complications such as graft failure and recurrence rate. photographs will be taken pre-op and post-op.

Eligibility criteria:
inclusion criteria: * primary pterygium exclusion criteria: * ocular surface disease * previous pterygium surgery

Keywords: pterygium excision cut and paste tisseel fibrin glue conjunctival autograft