Kornimate/medical-research-clean huggingface dataset:
the effects of cosmetic care on body image in young chinese breast cancer patients receiving chemotherapy

Conditions: Body Image

Summary: this study aimed to explore the effects of cosmetic care on body image (bi), and social avoidance and distress (sad) in young chinese breast cancer patients, aged 18-40 years old, receiving adjuvant chemotherapy. this was a single-center, 2-arm quasi-experimental study. the control group received usual care, while cosmetic care was added to the intervention group. the primary outcomes were bi and sad accompanying chemotherapy, and the secondary outcome was the appearance satisfaction.

background: the diagnosis and treatment of breast cancer may still bring severe psychological trauma to women. cosmetic care is an effective measure to enhance patients' psychosocial functioning, which can help cancer patients cope with disfigurement-related adverse effects. objectives: this study aimed to explore the effects of cosmetic care on body image (bi), and social avoidance and distress (sad) in young chinese breast cancer patients, aged 18-40 years old, receiving adjuvant chemotherapy. study design: this was a prospective, 2-arm quasi-experimental study, comprising two groups: the controlled group and the interventional group. in order to avoid interference, the two groups of participants were recruited at different periods. the control group was recruited from jan 2015 to mar 2015, and the intervention group was recruited from january 2016 to september 2017. all participants came from the department of a breast surgery in shanghai, china. control condition: participants in the control group received usual care during adjuvant chemotherapy. intervention: participants in the intervention group received cosmetic care in combination with usual care. ethical approval: ethical approval of this study was obtained from the ethical committee of a cancer center in shanghai. the approval number was 1403132-2. informed consent was explained to the participants and the forms were signed by them. data analyses: the ibm spss 22.0 was used to analyze all the data.

Eligibility criteria:
inclusion criteria: * primary breast cancer patients * aged 18-40 years old, who received surgery and adjuvant chemotherapy in our department * no prior neoadjuvant chemotherapy * being available to communicate by the novel social application "wechat" exclusion criteria: * diagnosis of psychiatric or intellectual impairment * having a history of neoadjuvant therapy * having distant metastasis * ecog\<2

Keywords: body image cosmetic care psychosocial support social avoidance and distress young breast cancer
integrative care and acupuncture in mohs surgery

Conditions: Quality of Life

Summary: mohs method is an effective surgical technique to remove skin cancerous tumors in the head-neck area. patients undergoing mohs surgery are struggled with emotional stress during the day of surgery, due to fear of significant damage to the body's image and anxiety about the need for repeated surgeries. in this study we will examine the effect of integrative medicine (including acupuncture, touch/manual, and breathing/relaxation modalities) on the reduction of anxiety and pain in patients undergoing mohs surgery.

mohs method is an effective surgical technique to remove skin cancerous tumors in the head-neck area, with immediate microscopic examination in a frozen slice of the full margin. patients undergoing mohs surgery are struggled with emotional stress during the day of surgery, due to fear of significant damage to the body's appearance and image and anxiety about the need for repeated surgeries performed on the same day to remove the tumor. in this study we will examine the effect of integrative medicine (including acupuncture, touch/manual, and breathing/relaxation modalities) on the reduction of anxiety and pain in patients undergoing mohs surgery. the study was designed on the basis of interdisciplinary collaboration of researchers from plastic, integrative and gynecological medicine.

Eligibility criteria:
inclusion criteria: \* patients referred to mohs surgery exclusion criteria: * pregnancy * hypertension treated with alpha and beta-blockers * chronic atrial fibrillation * insulin dependent diabetes type 1 * thyroid disease (hyperthyroidism)

Keywords: integrative medicine peri-operative anxiety pain mohs surgery
the effect of non-invasive auricular acupoint stimulation on slow transmission constipation

Conditions: Slow Transmission Constipation

Summary: objective to examine the therapeutic effect and safety of non-invasive auricular acupoint stimulation application on patients with slow transmission constipation. methods in a randomized clinical trial, 60 patients diagnosed with slow transit constipation (stc), ranging in age from 40 to 75 years, were allocated into two distinct cohorts: a study group and a control group. the study group, comprising 30 individuals, received a combination therapy of non-invasive auricular acupoint stimulation and prucapride, while the control group, also consisting of 30 patients, was administered prucapride as a monotherapy. to assess the efficacy of the interventions, various parameters were monitored, including serum levels of neuropeptide y (npy), nitric oxide (no), fecal water content, and gastrointestinal (gi) transit. the comparative therapeutic outcomes were determined by calculating symptom scores.


Eligibility criteria:
inclusion criteria: ① conformity to the diagnostic benchmarks for stc as delineated in the rome iv criteria; ② absence of ingestion of any medication influencing gastrointestinal motility within the preceding three months; ③ provision of informed consent after a comprehensive understanding of the study's objectives; ④ an age range of 40 to 75 years. - exclusion criteria: ① withdrawal from the therapeutic regimen; ② auricle or ear canal pathologies; ③ organic defecation disorder; ④ pregnant or lactating. -

Keywords: slow transmission constipation
inspiratory muscle training and low back pain

Conditions: Inspiratory Muscle Training; Low Back Pain; Respiratory Disorders

Summary: proprioceptive weighting changes may explain differences in postural control performance. in addition, the respiratory movement has a disturbing effect on postural balance. postural balance seems to be impaired in individuals with respiratory disorders. besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance. deficits in proprioception are found in a subgroup of patients with low back pain. in addition, disorders of respiration have been identified as strongly related to low back pain. the aim of the study is to clarify whether inspiratory muscle training has a positive effect on proprioceptive postural control in individuals with recurrent low back pain.


Eligibility criteria:
inclusion criteria individuals with low back pain: * age: 18-45 years old * at least 1 year of low back pain with/without referred pain in buttock/thigh * at least 3 episodes of disabling low back pain * at least a score of 20% on the oswestry disability index * willingness to sign the informed consent exclusion criteria: * history of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant * one of the following conditions: parkinson, multiple sclerosis, stroke, history of vestibular disorder, respiratory disease, pregnancy * radicular symptoms * not dutch-speaking * strong opioids * neck pain * smoking history
comparison of a new formulation of insulin glargine with lantus in patients with type 2 diabetes mellitus on basal plus mealtime insulin

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: * to compare the efficacy of insulin glargine new formulation and lantus in terms of change in hba1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus secondary objectives: * to compare the efficacy of insulin glargine new formulation and lantus in terms of occurrence of nocturnal hypoglycemia

the maximum study duration was up to approximately 58 weeks per participant, consisting of: * up to 2 week screening period * 6-month comparative efficacy and safety treatment period * 6-month comparative safety extension period * 4-week safety follow-up period in a subset of participants * a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to hoe901-u300

Eligibility criteria:
inclusion criteria : * participants with type 2 diabetes mellitus * substudy inclusion criteria: * completion of the 6-month study period in main study (visit 10) * randomized and treated with insulin glargine new formulation during the 6-month treatment period (baseline - month 6) exclusion criteria: * age less than (\<) 18 years * hba1c \ ) 10% at screening * diabetes other than type 2 diabetes mellitus * less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose * any contraindication to use of insulin glargine as defined in the national product label * participants using human regular insulin as mealtime insulin in the last 3 months before screening visit * use of an insulin pump in the last 6 months before screening visit * initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit * history or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period * pregnant or breast-feeding women or women who intend to become pregnant during the study period * substudy exclusion criteria: * participant not willing to use the adaptable injection intervals on at least two days per week the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
open-label study of ab-729, nucleos(t)ide analogue and pegylated interferon alfa-2a in subjects with chronic hepatitis b infection

Conditions: Chronic Hepatitis b

Summary: this is a randomized, open label, multicenter phase 2 study investigating the safety and antiviral activity of ab-729 in combination with ongoing na therapy and short courses of peg-ifnα-2a in subjects with chb.


Eligibility criteria:
inclusion criteria: * chronic hepatitis b virus infection with documentation at least 6 months prior to screening * subjects must have been receiving either taf, tdf (or equivalent), or etv consistently for ≥12 months prior to dosing day 1 * hbv dna \<lloq at screening * hbsag between 100 and 5,000 iu/ml at screening * subjects must be hbeag-negative at screening * fibroscan® result of ≤8.5 kpa within 6 months prior to dosing day 1 * medically stable based on physical examination, medical history, vital signs, laboratory values, and 12-lead electrocardiogram (ecg) at screening exclusion criteria: * evidence of co-infection with hepatitis a, c, d or e virus or human immunodeficiency virus (hiv) at screening * history of any clinically significant medical condition associated with chronic liver disease, cirrhosis, evidence of decompensated liver disease, or findings suggestive of hepatocellular carcinoma (hcc) at any time * contraindications to the use of peg-ifnα-2a or incapable of self-administration or assisted administration of peg-ifnα-2a * previous treatment with an experimental hbv-directed rna-interference or antisense oligonucleotide product.

Keywords: hepatitis b virus chronic hepatitis b hbv hepatitis chb
validation of a new algorithm for screening sleep apnea syndrome from electrocardiogram

Conditions: Sleep Apnea

Summary: sleep apnea syndrome is a prevalent disease, recognized as an independant risk factor for cardiovascular diseases the gold standard for the diagnosis of sleep apnea is the polysomnography. but polysomnography is time-consuming and very expensive. we developed an algorithm for screening sleep apnea from electrocardiographic signal. this would lead to the simplification of screening sleep apnea by using a two-channels recording device and computerizing the scoring of respiratory events. the validation of the algorithm will consist in comparing the number of apnea and hypopnea per hour of sleep (ahi) detected by the algorithm from the electrocardiographic signal recorded during a standard polysomnography in the center for sleep medicine and research in nancy, with the ahi resulted from the standard interpretation of the same polysomnography by experts in sleep scoring (gold standard).


Eligibility criteria:
inclusion criteria: * all patients with a polysomnography recorded in the center for sleep medecine and research (csmr) in nancy from january 2019 and june 2020 * results of standard interpretation of polysomnography giving a number of hypopnea and apnea per hour of sleep (ahi) superior to 5 exclusion criteria: * refusal to participate

Keywords: sleep electrocardiogram screening apnea polysomnography algorithm
safety and effectiveness of intravitreal conbercept for exudative circumscribed choroidal haemangioma

Conditions: Circumscribed Choroidal Haemangioma

Summary: this prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

this prospective clinical trial aims to evaluate the safety and effectiveness study of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma: (1)to evaluate therapeutic effect (including both anatomical and functional responses to intravitreal conbercept injection) of intravitreal conbercept injectionfor exudative circumscribed choroidal haemangioma; (2)to evaluate the safety (including side effects of the eye as well as side effects of system) of intravitreal conbercept injection for exudative circumscribed choroidal haemangioma.

Eligibility criteria:
inclusion criteria: * 1) patients with circumscribed choroidal haemangioma who was diagnosed using ophthalmoscopy, fluorescein/indocyanine green angiography, and ultrasonography; 2) presence of reduced visual acuity or metamorphopsia; and 3) subretinal fluid involving the fovea. exclusion criteria: * patients with abnormal liver function test results, liver disease, porphyria, or previous treatment for circumscribed choroidal haemangioma.

Keywords: conbercept circumscribed choroidal haemangioma safety effectiveness
population pharmacokinetics of ropivacaine

Conditions: Knee Osteoarthritis

Summary: the aim of this study was to investigate the pharmacokinetics of free and total ropivacaine after unilateral and bilateral tka. a population model was successfully built and peak free ropivacaine concentration stayed below previously proposed toxic thresholds in patients undergoing unilateral as well as bilateral tka receiving lia with high dose ropivacaine.

thirteen unilateral tka and fifteen bilateral tka patients were included in the study. all patients were operated in a well-described fast-track setup without use of drains or tourniquet.21 a standard midline skin incision with a medial para-patellar capsulotomy was used. all patients were operated with cemented cr components. in bilateral tka cases, both knees were operated in one setting with the left knee always being operated first, and the second knee being operated sequentially in the same setting immediately following closure of the first knee. patients undergoing unilateral tka received spinal anesthesia with 2 ml 0.5% hyperbaric bupivacaine, whereas patients scheduled for bilateral tka received spinal anaesthesia with 3 ml 0.5% hyperbaric bupivacaine. local infiltration anesthesia was performed as previously described with 200 ml 0.2% ropivacaine (400 mg) mixed with 1 ml 1 mg/ml epinephrine injected periarticularly in each knee. the first 50 ml were injected into the posterior capsule, 100 ml were injected into medial, anterior and lateral structures of the knee and capsule and the final 50 ml were injected in the subcutaneous tissue. all patients were mobilized on the day of surgery and thromboembolic prophylaxis started 6-8 hours postoperatively with rivaroxaban tablets (10 mg) given once daily until discharge. no extended thromboembolic prophylaxis was given to any patient. all patient received 1 g intravenous tranexamic acid preoperatively and 1 g 3 hours postoperatively. preoperative blood samples were taken within a week of surgery including electrolytes, hemoglobin and serum creatinine levels. baseline blood sample was taken just before incision of the first knee, and additional blood samples were drawn at 1, 5, 30 and 60 minutes as well as 2, 4, 8 and 24 hours after incision following unilateral tka and at 1, 5, 30 minutes after the incision of the first knee and 0, 5 and 15 minutes after incision of the second knee as well as after 1,2, 4 8 and 24 hours (total 9 and 12 timepoints within 24 hours for unilateral and bilateral tka, respectively). patient demographics were recorded and included age, gender, height and weight. ropivacaine measurement ropivacaine concentrations were determined in plasma samples using liquid-chromatography coupled to mass spectrometry following a fully validated method

Eligibility criteria:
inclusion criteria: patients undergoing unilateral tka (n=13) and bilateral tka (n=15) receiving lia according to standard protocol. exclusion criteria: patients not receiving lia revision tka
transcranial direct current stimulation for postoperative pain in knee arthroplasty

Conditions: Knee Replacement

Summary: the objective of this study is to detect the effect of trans-cranial direct current stimulation on postoperative pain and opioid consumption in total knee arthro-plasty patients. fifty patients undergoing unilateral tka will be randomly assigned to receive 4 sessions, total of 80 minutes of real (n=25) or sham tdcs (n=25). stimulation will be given on 4 consecutive postoperative days, group 1 will receive real stimulation with the active electrode over the leg representation of the motor strip (cortical motor area of the leg) and the reference electrode over the arm, group 2 will receive sham tdcs. pain level will be evaluated according to visual analogue scale (vas) and lanss pain scale before (base line) after 1st, 2nd, 3rd and 4th sessions.

the study aims to to detect the effect of trans-cranial direct current stimulation on postoperative pain and opioid consumption in total knee arthro-plasty patients. fifty patients undergoing unilateral tka will be randomly assigned to receive 4 sessions, total of 80 minutes of real (n=25) or sham tdcs (n=25). stimulation will be given on 4 consecutive postoperative days, group 1 will receive real stimulation with the active electrode over the leg representation of the motor strip (cortical motor area of the leg) and the reference electrode over the arm, group 2 will receive sham tdcs. pain level will be evaluated according to visual analogue scale (vas) and lanss pain scale before (baseline) after 1st, 2nd, 3rd and 4th sessions.

Eligibility criteria:
inclusion criteria: 1. providing informed consent to participate in the study. 2. age \>30 years and \<60 years both genders. 3. asa i to ii patients. 4. postoperative unilateral total knee arthroplasty. exclusion criteria: 1. contraindications to transcranial brain stimulation: presence of a history of epilepsy, implantable devices (ventriculo-peritoneal shunts, pacemakers, intracranial metal implants). 2. neurological or psychiatric pathology. 3. patients taking major centrally acting drugs (anti-epileptics or antidepressants) or high-dose opioid. 4. history of substance abuse. 5. severe cardio-pulmonary, renal, hepatic diseases. 6. pregnancy and lactation.

Keywords: arthroplasties, knee replacement
a study to investigate the safety, tolerability and pharmacokinetics of suvn-d4010 in healthy subjects

Conditions: Cognitive Disorders

Summary: the purpose of this study is to investigate the safety, tolerability and pharmacokinetics of suvn-d4010 in healthy male subjects following single or multiple ascending doses.

this is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of suvn-d4010 administered orally once a day to healthy male subjects. the study will be conducted under double blind conditions. the primary objective is to evaluate the safety and tolerability of suvn-d4010 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of suvn-d4010,if possible. the secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of suvn-d4010 in healthy male subjects.

Eligibility criteria:
inclusion criteria: * healthy male aged 18 to 45 years with a bmi between 18 and 30 kg/m2, (inclusive). exclusion criteria: * standard exclusion criterion for phase 1 clinical trial in healthy subjects. * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate * history or presence of gi, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by investigator.

Keywords: suvn-d4010 serotonin 4 (5-ht4) receptor first in human safety pharmacokinetics tolerability single dose repeat dose
genomic evolution of metastasis in gastric cancer

Conditions: Gastric Cancer; Metastasis

Summary: the aim of this study is to track tumor evolution of regional and distant metastases in gastric cancer using the next generation sequencing technologies.

gastric cancer is the fourth most common cancer in vietnam with high mortality rate. metastasis is the leading cause of death in gastric cancer patients, with median overall survival of less than 1 year. currently, there is no effective treatment because the molecular mechanism of metastasis remains unclear. the aim of this study is to use advanced ngs technologies to dissect the genomic changes (genetic, epigenetic and transcriptional changes) of the primary tumor and associated metastatic sites of the same patients. with that, the investigators can reconstruct the clonal evolution from primary tumor to metastasis, identify key pathways governing metastasis development that can be targeted for future therapeutic development.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18 years and older 2. histologically proven primary gastric adenocarcinoma and clinical evidence of metastasis (n1-3m1) 3. biopsies can be taken at multiple sites 4. no known other concomitant cancer diagnosis 5. signed informed consent exclusion criteria: 1. gastric adnocarcinoma cannot be confirmed primary 2. unable to undergo biopsy or surgery

Keywords: gastric cancer metastasis