Kornimate/medical-research-clean huggingface dataset:
combination chemotherapy in treating patients with refractory or recurrent solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of combination chemotherapy with paclitaxel and cisplatin plus flavopiridol in treating patients who have refractory or recurrent solid tumors.

objectives: i. determine the maximum tolerated dose of flavopiridol when administered in combination with paclitaxel and cisplatin in patients with refractory adult solid tumors. ii. investigate the clinical pharmacokinetics of intravenous flavopiridol when administered in combination with paclitaxel in these patients. iii. obtain preliminary data on the therapeutic activity of flavopiridol when administered in combination with paclitaxel in these patients. iv. evaluate surrogate markers of activity such as inhibition of pkc or cdk1 in these patients. outline: this is an open label, dose escalation study. patients receive paclitaxel iv over 3 hours on day 1. on day 2, patients receive cisplatin iv over 20 minutes followed by a 24 hour infusion of flavopiridol. courses are repeated every 21 days in the absence of disease progression or unacceptable toxicity. sequential dose escalation of flavopiridol is followed by sequential dose escalation of cisplatin. dose escalation in cohorts of 3-6 patients each continues until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. patients are followed every 6 weeks. projected accrual: approximately 46-73 patients will be accrued for this study within 6 more months.

Eligibility criteria:
disease characteristics: histologically proven solid tumors that are refractory or recurrent -no cns primary or metastatic disease patient characteristics: age: 18 and over performance status: karnofsky at least 60% hematopoietic: wbc at least 3,500/mm3 absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl ast and alt no greater than 2.5 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl cardiovascular: at least 6 months since prior cardiac arrhythmias, myocardial infarction, or congestive heart failure other: not pregnant or nursing effective contraceptive method must be used for 2 months after study completion not hiv positive no uncontrolled or serious infection no pre-existing grade 3 or greater neurotoxicity must be mentally capable of understanding the explanation of the study prior concurrent therapy: biologic therapy: at least 4 weeks since prior immunotherapy chemotherapy: at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy surgery: not specified other: no presence of toxic effects from prior therapy

Keywords: unspecified adult solid tumor, protocol specific
posterior tibial nerve prf for painful calcaneal fracture

Conditions: Calcaneus Fracture

Summary: patients who underwent pulsed radiofrequency (prf) treatment of the posterior tibial nerve under ultrasound guidance, which is routinely performed in our clinic for severe heel pain following a calcaneal fracture, were evaluated through interviews. the assessment was conducted using the visual analog scale (vas) for pain and the american orthopaedic foot and ankle society (aofas) score.

pain following a calcaneal fracture can arise from direct injury, traction injury, idiopathic mechanisms such as reflex sympathetic dystrophy/complex regional pain syndrome (crps), or nerve damage. since there is no single standardized definition or diagnosis for post-surgical nerve pain, such cases are described in the literature as neurapraxia, postoperative neuroma, unexplained heel pain, hypersensitive scar, or crps. typically, this type of pain manifests as burning, paresthesia, dysesthesia, and hyperesthesia. the tibial nerve plays a crucial role in the sensory and motor innervation of the heel. following a calcaneal fracture, direct nerve injury, compression, or inflammation of the surrounding tissues may contribute to pain. pulsed radiofrequency (prf) has been shown to alleviate chronic pain by delivering an electrical field to the nerve tissue at a controlled temperature of \<42°c without causing nerve damage. additionally, there is evidence supporting prf's effectiveness in pain relief for patients with various chronic conditions. in our study, the investigators aim to evaluate patients with persistent pain after a calcaneal fracture who have undergone prf treatment of the posterior tibial nerve. by monitoring these patients immediately after the intervention, we will assess changes in their pain scores. additionally, the investigators will compare them to patients with post-calcaneal fracture pain who have opted not to undergo the procedure.

Eligibility criteria:
inclusion criteria: * history of calcaneal fracture * vas score \>5 * pain persisting for more than 3 months after the fracture exclusion criteria: * presence of other foot pain-causing conditions (e.g., plantar fasciitis, heel spur) * additional fractures other than the calcaneus * pregnancy * coagulopathy or use of antiplatelet medications * mental illness impairing decision-making ability

Keywords: pulsed radiofrequency treatment tibial nerve
aesthetic outcomes of oncoplastic breast surgery for breast cancer in the upper inner quadrant

Conditions: Oncoplastic Breast Surgery; Breast Cancer; Aesthetic Outcomes

Summary: oncoplastic breast surgery, combining oncological resection with plastic surgical techniques, has emerged as an important surgical strategy to optimize conventional breast-conserving surgery. the upper inner quadrant is one of the most difficult and challenging tumor locations for surgeons to perform oncoplastic breast surgery. there is a pressing need to develop a simple and effective oncoplastic surgical technique to cope with the unfavorable anatomy and location of tumors in the uiq. here, we present a new oncoplastic volume displacement technique for uiq using the dsg flap. this trial was design to estimate the aesthetic outcomes of an oncoplastic technique using a droplet-shaped glandular flap for breast cancer in the upper inner quadrant.


Eligibility criteria:
inclusion criteria: * signed the informed consent. * female aged between 18 and 70 years. * pathologically diagnosed operable breast cancer. * who eastern cooperative oncology group (ecog) performance status of 0-1. * cancer located in the upper inner quadrant; single tumor or multiple tumors in the same quadrant. * the important organ functions meet the following criteria: * wbc \>=3.0 x 10\^9/l; neutrophilic granulocytes \>=1.5×10\^9/l; platelet \>=100 x 10\^9/l; hb \>=9 g/dl; * total bilirubin no more than 1.5 times the normal upper limit (uln); ast and alt no more than 1.5 times uln; akp no more than 2.5 times uln; * serum creatinine no more than 1.5 times uln or clearance rate of creatinine \>= 60ml/min; * thyroid stimulating hormone (tsh) \<= uln (t3, t4 levels need to be detected simultaneously if abnormalities, the patient can be included if t3, t4 levels is normal); * lvef basement \>= 50%. * adjust to the criteria of breast conserving surgery. exclusion criteria: * multifocal or multicentric disease. * tumor localized in the central quadrant or the distance to the nipple \< 2 cm； * diffused calcifications with fine plemorphic or fine linear or fine-linear branching morphology. * the ratio of tumor to breast \> 20%; * the diameter of tumor is up to 4 cm; * women in the early or intermediate stage of pregnancy; * prior history of breast radiation; * any severe comorbidities, inability to give informed consent or unavailability for follow-up.
carbohydrate restriction for gestational diabetes mellitus

Conditions: Gestational Diabetes Mellitus (GDM)

Summary: there is evidence that controlling total amount of carbohydrates is a strategy for controlling glucose levels in diabetes mellitus. there is not major evidence that any given macronutrient percentage may be recommended to treat a woman with gestational diabetes mellitus (gdm). in the investigators' country, insulin is the second-line treatment once medical nutrition therapy (mnt) has failed to control glucose levels during pregnancy. insulin treatment is more expensive and not as well accepted as mnt. the investigators have designed a randomized-controlled trial to assess whether a diet with 40% total calories from carbohydrates may reduce the need of insulin treatment in women with gestational diabetes, without having unfavourable pregnancy outcomes, in comparison with a diet with 55% total calories from carbohydrates.


Eligibility criteria:
inclusion criteria: * gestational diabetes mellitus * single pregnancy exclusion criteria: * multiple pregnancy * high risk pregnancy (any other concomitant illness, excluding hypertension and obesity) * low ability to understand and follow a diet * need to use insulin different from regular insulin

Keywords: gestational diabetes carbohydrate diet insulin
developing a peer support intervention for depression in scd

Conditions: Subjective Cognitive Decline; Depression in Old Age

Summary: the purpose of this study is to assess the feasibility, acceptability, and fidelity of an 8-week intervention where peer coaches will deliver depression care to adults 60 years of age or older who have depression and subjective cognitive decline.

with support from the madrc ore core, we will recruit 30 community-dwelling older adults to conduct an open pilot study of peerscog. trained and supervised peer coaches will deliver depression care to adults 60 years of age and older with depression and subjective cognitive decline in an 8-week intervention using video chats and texts. we will use mixed methods to assess feasibility, acceptability, and fidelity. we will use validated instruments to assess the preliminary outcomes, including depression, scd, functioning, and social factors at baseline, 8 weeks, and 3 months, and we will conduct post-intervention interviews with stakeholders at 8 weeks. older adult participants will be asked to name a study partner who will support the older adult throughout the study in terms of study enrollment. they may also have additional perspectives on the impact of impaired cognition and depression on daily living and related needs. the older adult will not be excluded if the study partner is not available.

Eligibility criteria:
inclusion criteria: * older adults aged 60+ * endorse subjective cognitive decline * endorse depressive symptoms * not currently experiencing suicidal ideation nor active, untreated manic, psychotic, or substance use disorder * fluent in english and able to give informed consent exclusion criteria: * meets diagnostic criteria for mild cognitive impairment or alzheimer's dementia * meets diagnostic criteria for a current major depressive disorder * have a history of neurological and psychiatric comorbidities such as major depressive disorder in the past 12 months
effects of docosahexanoic acid on neurocognitive impairment in hiv-infected patients

Conditions: Neurocognitive Impairment

Summary: neurocognitive impairment (nci) is one of the serious complications of elderly hiv-infected patients. the destruction of intestinal mucosal barrier and imbalance of bacterial flora caused by aging and hiv infection may be an important factor promoting the occurrence of nci. therefore, it is important to understand changes in gut microbiota of hiv-infected patients with nci. higher dietary intake of the essential fatty acid docosahexaenoic (dha) has been associated with better cognitive performance in several epidemiological studies. to date, data are limited showing that dha administration leads to benefits for behavioral disorders by modulating gut microbiota composition; the few studies on this subject, mostly completed in animal models. moreover，low levels of dha have been found in hiv-infected patients. the effect of dha supplementation on gut microbiota and nci status of hiv-positive patients have not been evaluated yet. investigators aim to implement a case-control study to identify the relationship between gut microbiota and nci in hiv-infected patients. at the meantime, investigators aim to implement a randomized, double-blind, placebo-controlled clinical trial to assess dha supplementation in hiv-infected patients with nci for 16 weeks. the effect of dha on gut microbiota and nci were evaluated. also, investigators aim to identify if the benefits for nci of dha caused by modulating gut microbiota composition and metabolites.


Eligibility criteria:
inclusion criteria: * male and female patients * age ≥18 years * established diagnosis of hiv-1 infection, under stable cart for the prior 6 months and throughout the study period * presence of neurocognitive impairment was assessed using the global deficit score (gds), calculated as the average of deficit scores across all neuropsychological test. the cut-off for nci was a gds score ≥ 0.5 exclusion criteria: * age \<18 years, * bmi \>30 kg/m2 * pregnancy or lactation * a history of diabetes mellitus, cardiovascular and cerebrovascular diseases, or serious diseases such as liver, kidney and hematopoietic system disease * known intolerance to n-3 pufa preparations.

Keywords: hiv-infected patients neurocognitive impairment gut microbiota fatty acid docosahexaenoic randomized controlled trial
teledermatology vs. face-to-face visits in the follow-up of patients with acne

Conditions: Acne Vulgaris

Summary: acne vulgaris is a common cutaneous inflammatory condition of sebaceous follicles that can profoundly affect patients' quality of life, especially at a young age. in this context the use of teledermatology can potentially reduce the healthcare costs associated to traditional consultations as well as the costs related to travel and loss of school/working time for the patient, with a clear benefit for the whole community. since 2016, the department of dermatology at inselspital hospital in bern has a portal and a smartphone app for online advice service. hereby the investigators propose to explicitly investigate the efficacy of this system in reducing healthcare costs as compared to traditional face-to-face consultations, in a cohort of patients with mild-to-moderate acne vulgaris.


Eligibility criteria:
inclusion criteria: * given written informed consent * mild-to-moderate acne as assessed by iga scale * willingness and ability to adhere the study protocol exclusion criteria: * need for systemic therapy for acne with isotretinoin * inability to use the teledermatology system

Keywords: acne telemedicine teledermatology
physical exercise for colorectal cancer patients after transanal total mesorectal excision

Conditions: Rectal Cancer

Summary: fecal incontinence is common in patients with rectal cancer after surgery. previous studies showed that pelvic floor muscle and external sphincter muscle training after stoma closure could improve the severity of incontinence and other fecal symptoms, but there is no study about the effects of pelvic floor muscle exercise intervention before stoma closure. we are wondering would the symptom of fecal incontinence recover sooner and better if we give the pelvic floor muscle exercise intervention before the stoma closure. this article aims at comparing the effects of pelvic floor muscle training before stoma closure on fecal incontinence (pre-intervention group) with pelvic floor muscle training after stoma closure (post-intervention group), and we hypothesise that the severity of fecal incontinence will improve sooner and better in pre-intervention group.


Eligibility criteria:
inclusion criteria: * rectal cancer patients who have received transanal total mesorectal excision(tatme) surgery; 20\~75 years old exclusion criteria: * terminal stage of cancer; unable to following orders due to poor cognitive condition; too weak to follow the experimental procedures; central nervous system lesions
effect of early education on the observance of cpap treatment

Conditions: Sleep Apnea Syndrome

Summary: sleep apnea (sa) affects more than 4% from general population and is largely underdiagnosed. sa can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). cpap is currently the gold standard treatment of sa and to prevent these events, with a major clinical benefit, long term adherence to cpap is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.

sleep apnea (sa) affects more than 4% from general population (20% of people over 65 years) and is largely underdiagnosed, it can be rise up by some factors such as: obesity, male gender. sleep apnea can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). cpap is currently the gold standard treatment of sa and to prevent these events, with a major clinical benefit, long term adherence to cpap is a significant problem where a significant rate of rejection and abundance after 6 months of treatment. the investigators hypothesize that an early education and information of sa (in the first 2 weeks after diagnosis of sa and one telephonic call/month while 5 months) would allow to increase significantly the optimal observance of cpap (\> 5 h/night). thus, in this study, we will compare evolution of the observance of cpap (h/night), of the apnea hypopnea index (ahi), patient knowledge of their sa and its deleterious health consequences in an early education and information during five months against a control group receiving only usual care (standard).

Eligibility criteria:
inclusion criteria: * patients affiliated or entitled to a french medical insurance * patients of both gender, aged from 18 to 80 years * patients with ahi \> 30/hour or between 15 \& 30/h with sleep fragmentation index (sfi) of more than 10/h * signature of consent exclusion criteria: * known diseases which contraindicated used of cpap treatment

Keywords: sleep apnea cpap
detoxification from the lipid tract

Conditions: COVID-19 Vaccine Adverse Reaction

Summary: apart from electroencephalogram biofeedback and electrical brain stimulation adopted for maintenance treatment, the study utilizes ultra-low frequency transcranial magnetic stimulation (ulf-tms) for initial γ-aminobutyric acid (gaba) stimulation. the cocktail therapy starts after the primary efficacy endpoint, and concomitant therapy is adopted throughout the study.

it was tested that gaba, in the joint action with topiramate, modulates macrophage activities by modulating cholesterol-metabolism associated molecules. gaba a receptors exhibit highly dynamic trafficking and cell surface mobility and influence on post-endocytic effects. benzodiazepines (bzds) exercise the mechanism of action by facilitating the binding of the inhibitory neurotransmitter gaba at various gaba receptors throughout the central nervous system (cns). alprazolam, a type of bzd, was tested by al-tubuly, aburawi, alghzewi, gorash and errwami in joint action with water-soluble beta blocker atenolol, in comparison with the non-selective β-adrenoceptor antagonist propranolol on the pharmacological effects on depression. the study hypothesizes that by replacing the water-soluble beta blocker to lipid-soluble one metoprolol, the effect of detoxification from the lipid and sebaceous immunobiological pathways can be achieved by the clathrin-dependent endocytosis process. even though partial progress was made in the nct05839236 trial by statin therapies, the therapeutic effects have not been lasting nor significant. the study develops from the previous protocol for a cocktail therapy by the joint mechanism of actions of alprazolam, metoprolol, and pravastatin sodium for the detoxification process.

Eligibility criteria:
inclusion criteria: * people who received full doses of covid-19 vaccines. exclusion criteria: * women during pregnancy.

Keywords: sebaceous immunobiology lipid depression
lapec for the treatment of severe constipation

Conditions: Cecostomy; Complications; Constipation

Summary: effective treatment for constipation is a real clinical challenge especially in patients with severe symptoms. dietary measures (bulking agents) and drugs (laxatives, stool softeners, suppositories and enemas etc.) have limited efficacy in severe cases. if conservative measures do not help, surgical therapies might be considered. subsequently, antegrade enemas through percutaneous colonic catheter were introduced as a less invasive option for treating severe constipation. the cecostomy has been performed laparoscopically, percutaneously, and with the laparoscopic-assisted percutaneous endoscopic cecostomy (lapec) technique. this approach allows patients to deliver osmotic agents to the right colon.the procedure has been demonstrated to be safe and effective in young adults and pediatrics. to date, there are only few studies evaluating the safety and efficacy of the lapec procedure in adults and all have retrospective profile. the aim of this prospective study is to compare short and long-term efficacy and safety of lapec in patients with severe constipation. symptoms of defecation will be the main outcome criteria.


Eligibility criteria:
inclusion criteria: * refractory (\> 6 months) and severe (based on a =kess \>11) and non-invasive therapeutic approaches, including an enhanced fiber diet, lifestyle changes, laxatives, and biofeedback failed. * slow transit constipation * anorectal malformation * mixed constipation (combination of outlet obstruction and slow transit) * hirschsprung's disease * idiopathic constipation ineffective to standard treatment * cauda equine syndrome * combination of spina bifida and tethered cord * colonic neuropathy. * persons 18 years or older at the time of signing the informed consent * signed informed consent exclusion criteria: * non-lapec cecostomy procedure * pre-existing severe electrolyte imbalance * chronic high rectal tone * advanced liver cirrhosis (child b or child c) * pregnancy or puerperium * advanced colorectal cancer * presence of ventriculoperitoneal shunt * colonic disease or surgery that might impact safety of percutaneous colostomy tube placement (right hemicolectomy, ic resection, previous apendicostomy) and confirmed inflammatory bowel disease * any other condition, which in the opinion of the investigator would interfere with study requirements

Keywords: laparoscopic-assisted percutaneous endoscopic cecostomy
aromatherapy to reduce pain and anxiety during cervical colposcopy

Conditions: Colposcopy

Summary: the purpose of this study is to determine whether aromatherapy with lavender oil compared to placebo lowers anxiety levels in women during colposcopy.

aromatherapy is a modality that might reduce anxiety. women experience high levels of anxiety and negative emotional responses at all stages of cervical cancer screening. high levels of anxiety before and during colposcopy can be bad. if lavender oil aromatherapy reduces anxiety, then simple use of this modality may improve experiences during colposcopy.

Eligibility criteria:
inclusion criteria: * tricare insurance beneficiary (military insurance) receiving care at nellis afb * all women at least 18 yrs of age undergoing colposcopy who have not previously participated in this protocol. exclusion criteria: * age \<18 years * pregnancy * breastfeeding * asthma * poor sense of smell * allergy to one of the essential oils * consumption of any analgesic * short-term anxiolytic (i.e. benzodiazepines) or chronic anxiolytic medications (i.e. ssri)

Keywords: colposcopy