Kornimate/medical-research-clean huggingface dataset:
assessment of complete pathologic response after neoadjuvant chemotherapy for breast cancer

Conditions: TN ER-/PR-/HER2- Breast Cancer; Triple Negative Breast Cancer; HER2-positive Breast Cancer; ERany/PRany/HER2+ Breast Cancer

Summary: this is a feasibility study to gain preliminary information regarding whether breast imaging with or without a core needle biopsy after neoadjuvant chemotherapy (nac) but before surgery can accurately predict complete pathologic response (pcr) in women with triple negative or her2- positive breast cancer. pcr is defined as having no residual invasive breast cancer or ductal carcinoma in situ.


Eligibility criteria:
inclusion criteria: * biopsy proven triple negative (tn) (er-/pr-/her2-) or her2 positive (erany/prany/her2+) breast cancer for which neoadjuvant chemotherapy is planned * a biopsy clip placed at the time of diagnostic biopsy * 18 years of age or older * must be able to read and write in english due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation * able to provide written consent prior to any research related activities exclusion criteria: * stage iv breast cancer * t4 breast cancer * previous ipsilateral breast cancer * any contraindication for undergoing a contrast-enhanced breast mri and/or the breast biopsy between chemotherapy and surgery

Keywords: breast cancer
outcome evaluation of patients after percutaneous tracheostomy due to respiratory failure in an intensive care unit

Conditions: Respiratory Insufficiency

Summary: to determine the morbidity and mortality of patients who have undergone percutaneous tracheostomy due to respiratory failure in the critical care unit and after intensive care in the internal medicine department, including follow-up of quality of life of these patients.


Eligibility criteria:
inclusion criteria: * mechanically ventilated critical care patients exclusion criteria: * all others

Keywords: tracheostomy
study about effect of preoperative bowel preparation versus no bowel preparation before spinal surgery

Conditions: Constipation; Ileus; Surgery

Summary: this study investigated the effect of preoperative bowel preparations for patients undergoing spinal fusion surgery.

this was a randomised clinical trial with one control group and two treatment groups. forty-five elective spinal fusion patients were randomised into three groups who received preoperative treatment with either enema of sorbitol and docusat natrium, bisacodyl suppository or no bowel preparation.

Eligibility criteria:
inclusion criteria: * patients undergoing spinal fusion surgery * age 15 years or older * the patients had to understand oral and written norwegian. * postoperative pain management via epidural catheter should have been planned. * exclusion criteria: * constipation * regularly use of enema

Keywords: spinal surgery bowel preparation ileus constipation well-being
investigation of efficacy and tolerability of wo 2707, a moistcream cremolum, in postmenopausal women suffering from symptoms of vaginal dryness

Conditions: Vaginal Atrophy

Summary: the objective of the clinical investigation is to evaluate the efficacy and tolerability of wo 2707, a moistcream cremolum, with respect to the application in postmenopausal women with symptoms of vaginal dryness.


Eligibility criteria:
inclusion criteria: 1. post-menopausal women with the subjective symptomatology of vulvovaginal atrophy with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 and a score of at least "2" (moderate) for the parameter dryness at screening and visit 1 (day 1) * thereof at least for 48 included patients: sexual activity with dyspareunia * thereof at least 32 included sexually active patients with at least moderate (score of "2") dyspareunia 2. natural cessation of last menstruation more than 12 months before screening or bilateral oophorectomy with or without hysterectomy more than 3 months before screening 3. signed written informed consent before participation in the clinical investigation exclusion criteria: 1. vaginal inflammation which is not caused by vulvovaginal atrophy 2. non-healed vaginal surgery 3. systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of serms (selective estrogen receptor modulators) within 3 months before visit 1 (day 1) and / or during the conduct of this clinical investigation 4. local hormonal therapy (vagina/vulva) within 3 months before screening (also when used for the brightening/pretreatment of cytological smears) 5. any use of products (including lubricants), other than the investigational medicinal device, applied intravaginally or on the vulva during the clinical investigation (except usual cleansing products) 6. systemic corticosteroids within 21 days before visit 1 (day 1) and during the conduct of this clinical investigation (corticoid asthma sprays are allowed) 7. use of antibiotics, antiseptics or antimycotics with expected or suspected systemic or vaginal/vulvar bioavailability within 21 days before visit 1 (day 1) and / or during this clinical investigation 8. known hypersensitivity against any of the ingredients of the investigational medical device 9. employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company
optimal dose of extracorporeal shock wave therapy after botulinum toxin type a injection for post-stroke spasticity

Conditions: Post-Stroke Elbow Spasticity

Summary: recently, it is known that the efficacy of botulinum toxin type a (btx-a) with extracorporeal shock wave therapy (eswt) is greater than that of btx-a with electrical stimulation in the management of post-stroke spasticity of the upper limb. however, it was not determined which dose of eswt is optimal as a adjuvant therapy after btx-a injection on the upper limb in patients with stroke. therefore, the aim of this study is to evaluate the optimal dose of eswt after botulinum toxin type a injection for post-stroke spasticity


Eligibility criteria:
inclusion criteria: * male or female * age ≥20 years * inpatients * elbow flexor spasticity in patients, confirmed to be mainly due to biceps brachii * modified ashworth scale (mas) ≥2, * at least a 3-month period from stroke, * written informed consent has been obtained exclusion criteria: * fixed contractures and/or deformities at the elbow, * previous fractures of the paretic upper limb, * peripheral nervous system disorders/myopathies, * previous btx-a treatment and/or eswt, * structural alterations in the soft tissue (e.g., fibrosis), * known allergy or sensitivity to the study medication or its components * presence of an unstable medical condition or uncontrolled systemic disease * any medical condition that may put the patient at increased risk with exposure to botulinum toxin therapy. (ex. myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis, or any other significant disease that might interface with neuromuscular function. * bleeding tendency and/or anticoagulation therapy * presence of infection or skin disorder at injection sites * females were are pregnant, nursing, or are planning a pregnancy during the study * females of child-bearing potential (including pre-menstrual woman), not using a reliable means of contraception * participant who should be withdrawn from the study in the opinion of the investigator for any reason
minimally invasive procedure versus conservative treatment in the management of calcaneal joint fractures

Conditions: Calcaneus ; Fracture ; Traumatology

Summary: calcaneal fractures, which affect the heel bone, are the most common type of tarsal fractures and often occur in young people, leading to long recovery times and significant social and economic consequences. traditional treatments include either non-surgical methods, like immobilizing the foot in a cast, or open surgery, which involves a large incision to fix the bone with plates. however, open surgery has a high complication rate, including issues with wound healing. recent advances have introduced minimally invasive surgical techniques, which use smaller incisions and have shown better results with fewer complications. this study aims to compare two treatment options for displaced calcaneal fractures: a minimally invasive surgery group and a non-surgical treatment group using a plaster boot. the goal is to determine whether minimally invasive surgery provides better outcomes for patients, such as faster recovery, fewer complications, and improved long-term function, to guide future treatment practices. thus, this is a prospective, randomised comparative study of the management of articular fractures of the calcaneus: conservative treatment versus minimally invasive surgery.


Eligibility criteria:
inclusion criteria: 1. patient aged 18 or over 2. patient with a posterior articular fracture of the calcaneus sanders ii to iv, less than 15 days old 3. patient affiliated to a social security scheme, 4. patient having given written consent following written and oral information. exclusion criteria: 1. patient with open calcaneal fracture 2. patient with bilateral calcaneal fracture 3. patient with extreme varus or valgus impingement of the fibula 4. patient with associated talar, tibial, femoral and/or pelvic fracture or associated spinal cord injury. 5. patient unsuitable for loco-regional anaesthesia (lra). 6. patient with neuro-psychiatric disorders resulting in an inability to follow a post-surgical or post-immobilisation rehabilitation protocol. 7. pregnant women 8. patient protected by law under guardianship or curatorship, or unable to participate in a clinical study under article l. 1121-16 of the french public health code.
the effect of functional activities and balance ability with taping in subjects of hemophilia

Conditions: Hemophilia

Summary: background hemophilia is a sex-linked genetic disorders. when the joint or the muscles is bleeding, it may cause haemarthrosis, synovium, cartilage tissue thickening, joint activity (range of motion) decreasing and other musculoskeletal and related disorder. patients will produce pain in the action, compensatory action occurs, thus causing recurrent of bleeding, and joint damage. there is high rate of ankle joint bleeding in hemophilia. the ankle articular joint disease will affect lower limbs activities, and the functional activities will impaired. review studies, in addition to physical therapy, kinesio taping is a common intervention to improve other subjects' static balance, proprioception, functional ankle stability, correct poor posture. the main intervention of this study is physical therapy and kinesio taping, expect to improve the stability and muscular strength of lower extremities, and balance, correcting gait and lower extremity functional activities of subjects with hemophilia.

methods: this study is a randomized controlled trial, the subjects were randomly divided into two groups, the control group received physical therapy once a week for a period of three months; experimental group received the same physical therapy in addition to treatment, but each will be accepted kinesio taping. experiments group carried out before and after the relevant tests, including: muscle strength, balance, lower extremity functional activities. the participants will be followed for the duration of physical therapy , an expected average of 3 months.

Eligibility criteria:
inclusion criteria: * subject of hemophilia * 20-65 years old exclusion criteria: * any history of surgery
combination oral acetazolamide and intravenous furosemide on acute decompensated heart failure outcomes

Conditions: Acute Decompensated Heart Failure

Summary: based on advor trial, the potential of adding acetazolamide in increasing the success of decongestion, the amount of natriuresis and diuresis. however, the use of intravenous acetazolamide may not be possible in indonesia, where the intravenous formulation is not available. this clinical research study is being conducted in single hospitals in indonesia. we aim to learn if oral acetazolamide in addition to furosemide intravenous works to treat congestion in acute decompensated heart failure, besides evaluating the total urinary output, change of nt pro bnp level, and safety profile of oral acetazolamide. the hypothesis of this study is oral acetazolamide works well to achieve successful decongestion.

this is a randomized, double blind study with 2 treatment groups. participants diagnosed with adhf who meet the inclusion criteria and no exclusion criteria are given an explanation regarding the research and additional therapy that will be given, then informed consent is requested. participants will be randomized to one of the two treatment groups by chance. patients randomized to the first group will receive intravenous furosemide and oral acetazolamide. patients randomized to the other treatment group will receive a combination of iv furosemide and placebo. it is expected that the patients of the treatment group with the combination therapy will have a faster reduction of their fluid overload. in consequence the treatment duration and total dose of diuretics administered will be shorter.

Eligibility criteria:
inclusion criteria: * agree to be included in the research by signing informed consent * patients with a clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload with a congestion score ≥2 (advor score) (e.g. edema (score 2 or more), ascites confirmed by physical examination or ultrasonography or pleural effusion confirmed by chest x-ray or echocardiography). * patients on routine oral loop diuretic therapy with a dose of ≥40 mg furosemide for ≥1 month * plasma nt-probnp levels that increase ≥300 pg/ml or the applicable cut-off according to the age range at the time of examination in the er. exclusion criteria: * subjects with acute coronary syndrome * history of congenital heart disease requiring surgical correction. * subjects in cardiogenic shock. * estimated glomerular filtration rate \<20 ml/min/1.73m² at the time of examination. * use of renal replacement therapy or ultrafiltration at any time before the study was included. * treatment with acetazolamide within 1 month before randomization. * exposure to nephrotoxic agents (i.e. contrast dye) is anticipated within the next 3 days * subjects who are pregnant or breastfeeding. * subjects with urinary incontinence who are unwilling to use a bladder catheter.

Keywords: oral acetazolamide acute decompensated heart failure congestion
dairy foods and blood pressure in multi-ethnic children

Conditions: Blood Pressure, High

Summary: to prevent excess increases in blood pressure in children by providing two servings of dairy foods as snacks daily at school. we hypothesize that children who receive the two dairy snacks will exhibit significantly less of an increase in blood pressure over six months as compared to control children.

the primary aim of the study is to determine the impact of dairy foods on blood pressure; however, we will also evaluate the effect of the intervention on body weight and composition. specifically, we will evaluate change in body mass index (bmi, kg/m2\], waist circumference in all subjects and body composition by bioelectrical impedance (bia) in a subset. we hypothesize that children receiving the dairy snacks will exhibit less increase in bmi and body fat than control subjects. we are studying a group of children at high risk for elevated blood lipids and glucose intolerance due to their racial/ethnic makeup and high prevalence of overweight and obesity. thus, we will evaluate the impact of the intervention on blood lipids, glucose and insulin in a subset of subjects. we hypothesize that children receiving the dairy foods will exhibit improvements in their lipids, glucose and insulin as compared to control children. we also plan to determine their eating habits through a 24 hour dietary recall at the beginning, middle and end of the study, with 2 additional recalls for the subset at each time point. dietary behavior and self efficacy will be analyzed before and after the intervention through a questionnaire. physical activity levels will be assessed by a short physical activity questionnaire on all students and through the utilization of accelerometers in the subset. our control schools will undergo the same testing, but will not receive any intervention.

Eligibility criteria:
inclusion criteria: * willingness to participate in the study * signed informed consent form by the parents and/or guardians * assent from the child exclusion criteria: * children with food allergies or other dietary requirements that restrict their ability to consume the snack * children with a chronic medical condition that may influence blood pressure or calcium metabolism such as renal disease or type 1 diabetes mellitus
effects of hypocaloric diets with different glycemic loads on pulse wave velocity

Conditions: Glycemic Index; Overweight; Obesity; Pulse Wave Velocity

Summary: worldwide, in terms of attributable deaths, the main intermediate risk factor for the development of cardiovascular diseases is systemic arterial hypertension, followed by overweight and sustained hyperglycemia. these factors have positively influenced public and private spending on health. the more robust studies showed that age is one of the main determinants of arterial stiffness. however, there is a possibility that other variables, such as elevated glucose levels, obesity, and systemic inflammation itself, as well as insulin resistance are important factors in this scenario. on the other hand, the measurement of the pulse wave velocity is widely acceptable for the evaluation of the arterial stiffness, inferring the cardiovascular risk in different populations. since arterial stiffness is influenced by hemodynamic forces and inflammatory mediators, which may be related to sodium and glucose balance, it is necessary to evaluate whether a hypocaloric and low glycemic load diet, in a thesis that decreases lipid and inflammatory levels, may have favorable effects on pulse wave velocity in overweight adults.

the diets will be calculated in microsoft excel 2018 software, using tables of nutritional composition, glycemic index and glycemic load, which have foods with high glycemic index or glycemic load (white rice, white bread, corn flakes, mashed potatoes, orange juice (brown rice, whole wheat bread, whole noodles, oat bran, yogurt, milk, apple, pear, peach). the methodology for calculating gc estimates will be based on the fao / who protocol. the diets will be designed in 1200, 1400, 1600, 1800 and 2000 kcal / day. all participants will be categorized according to one of the five levels of the diet's energy content. in addition, all patients will receive a leaflet with nutritional guidelines according to their diet. during the study, participants will be required to maintain their medication consumption, if any, as prescribed by a physician. to assess adherence to the diet, participants will consult with a nutritionist on a weekly basis and complete the 24-hour food recall. it will be measured the pulse wave velocity.this outcome will be evaluated before the beginning of the diets and 6 weeks after the beginning of the diets.

Eligibility criteria:
inclusion criteria: * both sex * between 20 and 59 years old * body mass index ≥ 25.0 kg/m² * physically inactive (physical activity \<150 min/week) exclusion criteria: * pregnant women * vegetarians * vegans * users of dietary supplements * smokers * alcohol abusers (men: more than 4 doses in a single day or more than 14 doses per week; women: more than 3 doses in a single day or more than 7 doses per week) * individuals with a previous diagnosis of hypertension * chronic kidney disease * type 1 or 2 diabetes mellitus * hypothyroidism * hyperthyroidism * events in the last 6 months (coronary artery disease, acute myocardial infarction, cerebral vascular disease, peripheral arterial disease, or heart failure)
study of amn107 with imatinib in gastrointestinal stromal tumors (gist)

Conditions: Gastrointestinal Stromal Tumors

Summary: this study is an open-label, multicenter, phase i dose-escalation study of the combination of amn107 and imatinib (sti571) in patients with imatinib-resistant gist. this study is designed to determine the phase ii dose of amn107 and imatinib when administered together in patients with imatinib-resistant gist, and to characterize the safety, tolerability and pharmacokinetic (pk) profile of this combination.


Eligibility criteria:
inclusion criteria: * patients with gastrointestinal stromal tumor (gist). * patients who have had disease progression during imatinib therapy with 800 mg. * ability to understand and willingness to sign a written informed consent document. exclusion criteria: * patients with prior or concomitant malignancies other than gist with the exception of previous or concomitant basal cell skin cancer or previous cervical carcinoma in situ. * a history of impaired cardiac function or uncontrolled cardiovascular disease. * severe and/or uncontrolled concurrent disease that could cause unacceptable safety risks such as impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of amn107. * currently taking certain medications that could affect an electrocardiogram result. * women who are pregnant or breast feeding. * patients unwilling or unable to comply with the protocol. note: additional inclusion and/ or exclusion criteria may apply.

Keywords: gist amn107 gastrointestinal stromal tumors
outcomes of emotion regulation therapy in young autistic adults

Conditions: Autism

Summary: this pilot study is designed to investigate the clinical outcomes and neural mechanisms of emotion regulation behavioral treatment , in a small sample of young adults diagnosed with autism spectrum disorder.

five young adults with asd with emotional/behavioral challenges that are attributed to emotion dysregulation will be enrolled into an emotion regulation (er) intervention administered twice weekly for a total of 16 sessions. participants will be evaluated pre- and post-treatment using behavioral and imaging measures, and at mid-treatment and 2-month follow-up using behavioral measures administered electronically and/or via phone interview.

Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder * ages 18-40 * estimated full-scale iq ≥ 80 * t score \> 60 on either the externalizing or internalizing symptoms scores of either the adult behavior checklist (abc-l) or the adult self report (asr) * participation in previous study at the olin center ("social emotional study"; e-hhc- 2018-0241) exclusion criteria: * intellectual disability (estimated full scale iq\<80 * history of a significant head injury (severe concussion, hospitalization) * history of neurosurgery * history of epilepsy, stroke, ms, a neurodegenerative disorder, or any other neurological disorder * a current major medical condition (e.g. cancer, heart failure) * current substance use (determined by urine screen done to all participants before each mri scan) * in-body metal implants (e.g. surgical clips, certain pacemakers) or history of exposure to metal shards or other mri contraindications * pregnancy

Keywords: emotion regulation