Kornimate/medical-research-clean huggingface dataset:
anxiety reduction in type 2 diabetes through breathing exercisespatients with type 2 diabetes

Conditions: Type 2 Diabetes; Type 2 Diabetes Treated With Insulin

Summary: injection-related anxiety is a significant barrier to the management of type 2 diabetes, adversely affecting treatment adherence and glycemic control. this study investigated the effectiveness of breathing exercises in reducing anxiety during the first insulin injection.

this study is designed as a randomized, double-blind, experimental study. data from patients who agree to participate in the study was collected by the researcher prior to testing. variables collected include age, gender, marital status, education level, occupation, body mass index (bmi), hba1c levels and diabetes duration, as well as scores on the subjective disorders scale (suds), state anxiety inventory (stai-i) and trait anxiety inventory (stai-ii). patients were then randomly assigned to the intervention (breath) and control groups using a computer-generated randomization table. allocation continued until the blocks in each group are equal in size. participants in the breath and control groups was identified prior to the intervention. all participants completed a form with demographic information. the participants in the control group completed the suds, stai-i and trait anxiety inventory (stai-ii) scales before the test. they then had 30 minutes of free time. the suds, stai-i and stai-ii scales were then completed for the post-test. in the breath intervention group, participants were first instructed on the breathing exercises (at the lowest point of breathing, close the left nostril with the right index finger and exhale through the right nostril). breathe in through the right nostril, then close it with your thumb and breathe out through the left nostril. this cycle was repeated at least three more times. participants completed the suds, stai-i and stai-ii scales before the test, following by a single breath session (approximately 30 minutes). after the test, the suds, stai-i and stai-ii were administered. standard treatment for all patients was not interrupted during the study. appointments for the randomized patients were made by telephone to avoid encounters and mutual interference between the groups.

Eligibility criteria:
inclusion criteria: * type 2 diabetes diagnosis for at least one year, * followed up at the diabetes outpatient clinic, * literate and able to understand and complete study forms, * first-time insulin injectors in addition to oral antidiabetics, exclusion criteria: * younger than 18 years * older than 65 years * having visual, auditory, or mental impairments that would affect to complete the forms
contribution of f18-fdg pet/ct to the early assessment of pazopanib therapy efficacy in advanced soft tissue sarcoma

Conditions: Soft Tissue Sarcoma (STS)

Summary: soft tissue sarcoma (sts) is a rare tumor but can grow in different areas, for example, in 60% in limbs and about 20 % in retroperitoneum; and frequently is inoperable. despite novel therapy in advanced cases survival is still short, approximately 12 month. pazopanib oral angiogenesis inhibitor was recently shown as promising drug for advanced pretreated sts. functional imaging especially f18-fdg pet/ct is a good modality for fdg avid tumor either for pre- / post- treatment evaluation or follow up. early detection of treatment response to therapy by whole body fdg pet/ct allows for change of treatment as early as possible,when the tumor is non-responsive before serious side effects appear or before depletion of body resources. the aim of the study is to investigate the contribution of fdg pet/ct to assessment of treatment response.


Eligibility criteria:
inclusion criteria: * patients with advanced soft tissue sarcoma prior to pazopanib treatment exclusion criteria: * other treatment * fdg negative tumor

Keywords: soft tissue sarcoma pazopanib f18-fdg pet/ct
improving aphasia using electrical brain stimulation

Conditions: Stroke; Aphasia

Summary: language and communication are essential for almost every aspect of human life, but for people who have aphasia, a language processing disorder that can occur after stroke or brain injury, even simple conversations can become a formidable challenge. speech and language therapy can help people recover their language ability, but often requires months or even years of therapy before a person is able to overcome these challenges. this research will investigate non-invasive brain stimulation as a way to enhance the effects of speech and language therapy, which may ultimately lead to better and faster recovery from stroke and aphasia. the investigators hypothesize that participants with aphasia who receive speech and language therapy paired with active electrical brain stimulation will improve significantly more on a language comprehension task than those who receive speech and language therapy paired with sham stimulation.


Eligibility criteria:
inclusion criteria: 1. 18 years or older. 2. no diagnosis of neurological disorder (other than stroke). 3. no diagnosis of psychiatric disorder. 4. no seizure within the past 6 months. 5. not pregnant. 6. in chronic phase of recovery, defined as at least 6 months post-stroke. 7. not undergoing speech and language therapy targeting auditory comprehension or attention for the duration of the study. 8. no metal implants in the head. 9. no unhealed skull fractures. 10. onset of aphasia related to left hemisphere stroke. 11. damaged brain tissue from stroke does not overlap with left hemisphere dorsolateral prefrontal cortex. 12. mild to moderate aphasia. 13. cognitive ability minimally within functional limits. 14. able to pass vision and hearing screening (with use of corrective aids if needed; eyeglasses, hearing aids). 15. willing to allow audio-recording of study sessions. exclusion criteria: 1. younger than 18 years old. 2. diagnosis or history of neurological disorder other than stroke. 3. diagnosis or history of psychiatric disorder. 4. history of seizures within the past 6 months. 5. pregnant. 6. \<6 months post-stroke (however, if this is only exclusionary criterion met, participant can be re-evaluated at the 6-month mark if still interested in the study) 7. currently undergoing speech and language therapy targeting auditory comprehension or attention. 8. metal implants in the head. 9. currently has a skull fracture. 10. onset of aphasia related to etiology other than left hemisphere stroke. 11. damaged brain tissue includes left hemisphere dorsolateral prefrontal cortex. 12. no aphasia or severe aphasia. 13. cognitive ability below functional limits. 14. unable to pass vision and/or hearing screening with use of corrective aids. 15. unwilling to allow audio-recording of study sessions.

Keywords: tdcs attention language speech-language therapy
language function in patients with brain tumors

Conditions: Brain Cancer; CNS Cancer

Summary: the purpose of this study is to use an imaging method called functional magnetic resonance imaging (fmri) in patients who have a tumor near an area of the brain that is believed to control language. the fmri is a new kind of imaging that uses a strong magnetic field to look at functioning brain tissue. this kind of imaging will be used to study the effect of the brain tumor on your speech.


Eligibility criteria:
inclusion criteria: * patient in whom a tumor invades or is directly adjacent to the expected location of one of the language centers. * at least 18 years of age * english as first language exclusion criteria: * patients with high grade tumors * history of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia), * history of the following neurological conditions: cva, demyelinating conditions, cerebral palsy, alzheimer's disease. * history of significant claustrophobic reactions. * pregnancy * standard contraindications to mr examinations (e.g. implanted stimulator) * patients, who were treated prior to our first scan, will not be eligible to participate in this study
cross-sectional study of anorectal function and quality of life in patients with middle and low rectal cancer

Conditions: Rectal Cancer

Summary: understanding the quality of life and anorectal function changes in patients with middle and low rectal cancer after surgery can guide patients to recover after surgery and provide a valuable reference for surgeons in the selection of surgical methods. the purpose of this study is to: (1) investigate the complication rate, recurrence and metastasis rate and survival of patients with middle and low rectal cancer. (2) qlq-c30 and qlq-cr29 questionnaires were used to assess the quality of life of patients with low- and middle-level rectal cancer at different periods after surgery. (3) wexner constipation score and lars syndrome score for anorectal function after operation for low rectal cancer. (4) the cipe ejaculatory function score, iief-5 international erectile function score, and fsfi-6 female sexual function index were used to assess the changes in sexual function of patients with low- and middle-position rectal cancer after surgery.


Eligibility criteria:
inclusion criteria: 1. postoperative patients with middle rectal cancer 2. postoperative patients with low rectal cancer exclusion criteria: (1)patients refused to participate
clinical relevance of detecting molecular abnormalities in glial tumor exosomes

Conditions: Glioma

Summary: the purpose of this pilot study is that exosomes constitute a more interesting support for analyzes allowing a broader screening of molecular alterations to be carried out with more reliable, more sensitive and more efficient results than the reference foundation one liquid cdx test.

gliomas are the most common primary brain tumors in adults. the heterogeneity of tumors, the lack of reliable criteria for identifying different subtypes make their histopathological diagnosis and their management complex. the molecular profiling from circulating exosomes is one of the most promising approaches to better characterize gliomas. we will demonstrate the superiority of detection by ngs of molecular abnormalities present in exosomes from glioblastomas, compared to detection by the foundation one liquid cdx test on ctdna.

Eligibility criteria:
inclusion criteria: * subject of both sexes at least 18 years of age with glioblastoma. * patient for whom an fmi test is indicated, progressing after a 1st line following the chemotherapy and radiotherapy protocol (stupp protocol) * patient affiliated to french social security exclusion criteria: * patient included in another research protocol using an experimental molecule. * any medical or psychiatric condition which, in the investigator's opinion, would preclude the patient from adhering to the protocol or completing the study per protocol * patient under legal protection, guardianship or curatorship * patient with active malignancy or a previous malignancy within the past 5 years; except for patient with resected basocarcinoma and resected carcinoma in-situ of the cervix.
a safety study to determine the maximum tolerated dose of elesclomol sodium in patients with solid tumors

Conditions: Metastatic Solid Tumors

Summary: the aim of this study is to determine the safety and tolerability of elesclomol sodium at escalating doses (ultimately identifying the maximum tolerated dose). this study will also characterize the pharmacokinetics of elesclomol and evaluate its anti-tumor activity in advanced solid tumors that are metastatic and unresectable.


Eligibility criteria:
inclusion criteria * males and females at least 18 years of age * histologically- or cytologically- confirmed solid tumor (except melanoma) that is metastatic or unresectable * advanced or metastatic cancer for which no standard therapy exists or that has progressed despite standard therapy * acceptable organ and marrow function during the screening period as defined by the protocol. * reliable venous access suitable for weekly study drug infusions * willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures exclusion criteria * pregnant or breast-feeding women * have had chemotherapy or radiotherapy within 4 weeks prior to entering the study * primary brain tumors or active brain metastases * treatment with chronic immunosuppressants * significant cardiovascular disease, severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration

Keywords: cancer metastatic elesclomol sodium tumor advanced solid tumors that are metastatic and unresectable
a phase iiib study of duotrav to treat glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to assess patient compliance with duotrav versus concomitant administration of timolol 0.5% plus travatan in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * adult patients with open-angle glaucoma or ocular hypertension; * other protocol-defined inclusion criteria may apply. exclusion criteria: * visual acuity worse than 0.60; * other protocol-defined exclusion criteria may apply.

Keywords: open-angle glaucoma or ocular hypertension
carbetocin versus oxytocin in caesarean section for the control of postpartum haemorrhage

Conditions: Postpartum Haemorrhage

Summary: post-partum haemorrhage is one of the life threatening emergencies. it accounts for nearly one-quarter of all maternal death worldwide. atonic uterus contributes about 80% among the causes. uterotonic drugs are administered following the delivery of baby both in vaginal and caesarean delivery for prevention of pph. however postpartum haemorrhage cannot always be prevented. but, the incidence and especially its magnitude can be reduced by assessing the risk factors and following the guidelines. the intelligent anticipation, skilled supervision, prompt detection and effective institution of therapy can prevent a normal case from undergoing disastrous consequences. this study will be carried out at bangabandhu sheikh mujib medical university (bsmmu) within six months after approval. this is a randomized control trial which will compare efficacy of carbetocin and oxytocin for the control of pph. structured questionnaire, data sheet, hospital indoor documents i.e. patient chart, operation notes, surgeons visual estimation of blood loss etc will be used as study tool. ethical clearance will be obtained from institutional review board of bsmmu. written informed consent will be obtained from the patient or from her legal guardian. patient confidentiality will be strictly maintained. no name, address or contact details of the patient will be divulged.


Eligibility criteria:
inclusion criteria: * patient with risk factors for primary post-partum haemorrhage such as: multiple pregnancy, one or more previous caesarean section, presence of uterine fibroids, previous myomectomy, presence of placenta previa, past history of pph, fetal macrosomia and fetal malformations associated with polyhydramnios exclusion criteria: * presence of hypertension, eclampsia, cardiac, renal or liver diseases, epilepsy, general anaesthesia, as well as women with history of hypersensitivity to carbetocin according to the br national formulary. patients unwilling to give consent for this study are also excluded

Keywords: general: to compare carbetocin and oxytocin for the control of pph.
upper extremity rehabilitation with the burt robotic arm

Conditions: Stroke; Hemiparesis

Summary: the overall objective of the proposed study is to carry out usability and design-evaluation assessments of the burt robotic device for delivering long-term intervention in stroke survivors. the burt is an upper extremity robotic device that enables the user to see and feel engaging games that encourage intensive therapy. the investigators intend to recruit up to 10 stroke survivors over the course of the study. participants will train their arm with the burt for 18 sessions over approximately 6 weeks then participate in a question/answer formatted discussion with research staff to discuss the usability of the device. the investigators will also assess participant's arm function at baseline and after the training sessions.


Eligibility criteria:
inclusion criteria: * male and female, age 18-80; * having had a stroke (ischemic or hemorrhagic) at least 6 months prior to study * moderate to severe upper-limb motor impairments (score of 15-45 out of 66 on the fugl- meyer scale); * community dwelling; * able to physically fit in the device. exclusion criteria: * current participation in rehabilitation program targeting upper extremity function; * cognitive impairment resulting to inability to follow instructions or inability to sustain attention for more than 10 minutes; * visual impairments not corrected with lenses (visual loss); * aphasia sufficient to limit comprehension and completion of the treatment protocol; * no more than moderate impairments in paretic ue sensation, passive range of motion, and pain that would limit ability to engage in therapy; * increased muscle tone (passive movement is difficult); * previous diagnosis of neurological diseases other than stroke; * other conditions affecting function of the stroke affected upper limb; * individuals who present with the following: open wounds, fragile skin, active infection

Keywords: stroke hemiparesis robotic
personalized transcranial magnetic stimulation treatment for depression

Conditions: Depression

Summary: this proposal seeks to conduct a pragmatic single arm, open label pilot implementation to validate our individualized functional magnetic resonance imaging (fmri) connectome-guided localization approach for accelerated tms among asian patients with depression. participants will be patients with major depressive disorder not responding to standard treatment, with no exclusions to fmri or transcranial magnetic stimulation (tms) (essentially metal implants in the head) and willing to participate in the pilot. all participants will undergo mri scans before and after the accelerated tms treatment. the multi-session hierarchical bayesian model (ms-hbm) approach will be used to estimate individualized connectome-guided target locations. patients will undergo accelerated tms applied to individualized connectome-guided target locations (based on the ms-hbm approach). patients will undergo 10 sessions (each session lasting 10 min) spread out over 10 hours each day for 5 consecutive working days. all clinical outcome data will be collected for each patient by a pre-defined questionnaire at four time points: at baseline, post-treatment, 1 month and 3 months during follow-up. the clinical outcome data will be analyzed using linear regression or repeated analysis of variance (anova) after adjusting for baseline clinical characteristics and socio-demographics. trajectories of the clinical outcome data at baseline, post-treatment and all follow-up time points will be plotted and compared with time series statistical analysis models with the other clinical and socio-demographic characteristics included as confounders.


Eligibility criteria:
inclusion criteria: 1. age ≥ 21 years. 2. dsm-5 diagnosis of current major depressive episode. 3. montgomery-asberg depression rating scale score of 20 or more. 4. inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication. 5. able to give informed consent. exclusion criteria: 1. dsm-5 psychotic disorder 2. drug or alcohol abuse or dependence (preceding 3 months). 3. rapid clinical response required, e.g., high suicide risk. 4. significant neurological disorder, which may pose increased risks with tms, e.g., epilepsy. 5. metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device. 6. pregnancy. 7. unsuitable for mri.

Keywords: neuronavigated itbs accelerated
tens unit to decrease pain after laminaria insertion

Conditions: Second Trimester Abortion

Summary: the purpose of the study is to learn more about the transcutaneous nerve stimulation (tens) unit, an over-the-counter option for pain relief that is not a medication. the investigators are hoping to find out if this device decreases pain during and after laminaria placement for patients undergoing both elective and medically indicated second-trimester termination of pregnancy.

to compare the maximum pain scores reported during the interval between osmotic dilator placement and d\&e procedure of patients receiving the standard of care plus sham placebo and those who use an adjunctive transcutaneous electrical nerve stimulation (tens) unit in addition to standard of care. secondary objectives include comparing pain scores at the time of laminaria insertion, assessing the number and duration of tens sessions, additional analgesic use, satisfaction with pain management, and patient perception of the ease of use of the tens unit.

Eligibility criteria:
inclusion criteria: * patients undergoing laminaria insertion for d\&e procedure * age 18 years or older * capability and willingness to send and receive sms messages by phone and complete web-based surveys * capability to read and understand directions for using a tens unit * capability to operate a tens unit according to provided directions exclusion criteria: * inability to complete the informed consent in english * exposure to adjunctive pharmacologic cervical preparation (misoprostol or mifepristone) within 48 hours of the d\&e procedure * contraindication to ibuprofen or bupivacaine * contraindication to tens, including cardiac pacemakers, epilepsy, bleeding disorders, cancer, and concurrent use near transdermal drug delivery systems * previous participation in this trial * prior use of tens unit
double-blind ipragliflozin add-on study in japanese participants with type 2 diabetes mellitus who have inadequate glycemic control on sitagliptin (mk-0431j-843)

Conditions: Type 2 Diabetes Mellitus

Summary: this is a study to assess the safety and efficacy of the addition of ipragliflozin once daily in japanese participants with type 2 diabetes mellitus (t2dm) who have inadequate glycemic control on sitagliptin, diet, and exercise therapy. the primary hypothesis for this study is that the addition of ipragliflozin compared with placebo provides greater reduction in hemoglobin a1c (hba1c) as assessed by change from baseline at week 24.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * inadequate glycemic control on diet/exercise therapy and sitagliptin monotherapy * hba1c ≥7.0% and ≤10.0% before study start exclusion criteria: * history of type 1 diabetes mellitus or a history of ketoacidosis * history of any of the following medications: thiazolidinediones (tzd) and/or insulin within 12 weeks prior to study participation and sodium glucose cotransporter 2 (sglt2) inhibitors anytime * currently has a urinary tract infection or genital infection with subjective symptom