Kornimate/medical-research-clean huggingface dataset:
bolt csp-m holter study

Conditions: Heart Failure; Bradycardia

Summary: the purpose of this study is to investigate the cardiac electrical characteristics in different pacing outputs and body positions in lbb area pacing (lbbap), from which the findings may help to develop and support data validation of a novel algorithm for lbb capture determination for lbbap.

among lbb area pacing (lbbap), it has been reported that left ventricular (lv) septal pacing (lvsp), which refers to a pacing approach that only captures the lv septal myocardium, produces homogeneous electrical propagation in the septum and leads to delayed lv lateral wall activation. although large randomized trials are lacking, small observational studies have shown more preserved physiological ventricular depolarization, or superior electrical and mechanical synchrony of the lbb capture over lvsp. during the implantation of a device, the most commonly used method to distinguish lvsp from the lbb capture is to pace with different pacing outputs. a transition will be found in the ecg morphology with changes in the lv activation time if the pacing capture threshold (pct) of the local myocardium is different from that of the lbb (i.e., lbb-pct), indicating a transition between capturing the lbb and lvsp without any lbb capture. so far, there is no systematic investigation on the egm characteristics or correlation between ecg and egm characteristics at different conduction system capture status. findings from this study will help to better characterize egm characteristics and to develop an optimal lbbap modality to differentiate lbb capture.

Eligibility criteria:
inclusion criteria: * patients aged \>=18 years * patients who are willing to provide informed consent * patients who have received lbbap therapy \>= 1 month for 1 to 4 months (including 1 and 4 month) * patients implanted with a single/dual-chamber pacemaker or a crt-p with lbbap lead connected to rv port * implanted device can provide at least 3-channel real-time intracardiac electrogram exclusion criteria: * patients who are pregnant or have a plan for pregnancy during the study * patients who have medical conditions that would limit study participation * patients who were already enrolled in clinical trial(s) which would impact study participation

Keywords: lbbap lbbp lvsp
a trial of hrs-4508 in subjects with locally advanced or metastatic non-small cell lung cancer

Conditions: Solid Tumor

Summary: the study is being conducted to evaluate the efficacy, safety, and orr of hrs-4508 in subjects with locally advanced or metastatic non-small cell lung cancer; evaluate the pharmacokinetic (pk) characteristics of hrs-4508 and other efficacy endpoints for the treatment of locally advanced or metastatic non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: 1. age: 18 to 80 years old; both men and women are welcome; 2. locally advanced or metastatic non-small cell lung cancer that has failed standard treatment or cannot tolerate standard treatment regimens. 3. ecog ratings of 0 or 1. 4. expected survival period ≥ 12 weeks. 5. at least one measurable lesion outside the central nervous system that meets the recist v1.1 standard definition. 6. willing to participate and comply with the requirements of the research protocol, and willing to cooperate with follow-up visits. exclusion criteria: 1. accompanied by untreated or active central nervous system (cns) tumor metastasis. subjects with a history of meningeal metastasis or current meningeal metastasis 2. there have been significant severe infections and major surgeries in the past 4 weeks 3. existence of previous or concurrent malignant tumors 4. difficult to treat nausea, vomiting, or other gastrointestinal diseases that affect the use of oral medication 5. having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration; experiencing traumatic minor surgery within 7 days prior to the first administration of medication
clinical and molecular study of endometriosis and adenomyosis

Conditions: Endometriosis; Adenomyosis

Summary: the purpose of this study is to determine whether endometriosis and adenomyosis are progressive diseases, in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions size, and recurrences. we also aimed to address molecular questions on immune dialogues between ectopic lesions and the eutopic endometrium, auto-immunity in endometriosis and adenomyosis and the role of the microbiota in their respective pathophysiologies.

endometriosis and adenomyosis are benign gynecological conditions which affect more than 10% of women, that typically cause pain and / or infertility, thereby exerting a negative impact on the patients' quality of life. although the pathogenesis of endometriosis and adenomyosis are controversial, both diseases are defined by the presence of endometrial tissue outside the uterine cavity. endometriosis is a heterogeneous disease, with three phenotypes: superficial peritoneal endometriosis (sup), ovarian endometrioma (oma), and deep infiltrating endometriosis (die) the most widely accepted pathophysiological hypothesis for endometriosis is that of the implantation of ectopic endometrial cells following peritoneal reflux. endometriosis can be associated with adenomyosis, also heterogeneous, characterized by the infiltration of endometrial tissue into the myometrium, presenting different forms: diffuse, focal or cystic. due to diseases heterogeneity, the diagnosis of endometriosis and adenomyosis is difficult and affected patients are subject to a long delay for appropriate management. we hypothesize that the disease may be progressive in terms of symptoms (pain, abnormal uterine bleeding and infertility), anatomical lesions and recurrences. furthermore, highlighting specific clinical and molecular markers would shorten the diagnostic time.

Eligibility criteria:
inclusion criteria: * women of age between - 18 and 42 years old. * in-service care for one of the pelvic pain and/or infertility, or for a pelvic mass. * having a radiological diagnosis made by a referral practitioner and/or operated in the department exclusion criteria: * hiv-positive women, hbv and hcv * during pregnancy * having a cancer diagnosis * refusing to sign a consent.

Keywords: endometriosis adenomyosis pain infertility disease progressiveness
fecal microbial transplantation for the treatment of fecal incontinence in women

Conditions: Fecal Incontinence

Summary: open label pilot study assessing fmt to treat fecal incontinence in women 50 years of age and older.

fecal incontinence, also known as accidental bowel leakage, is a common condition that is an immense burden to older women, caregivers, and the health care system. the overall goal of this study is to gather pilot data in order to conduct a future randomized controlled trial (rct) for a novel treatment for fecal incontinence in older women utilizing fecal microbial transplantation (fmt). the investigator's hypothesis is that infusion of intestinal microbiota from healthy donors to older women with fecal incontinence will increase microbial diversity, reduce symptom severity, and improve quality of life. this study is a single arm, open-label clinical trial of fmt for the treatment of fecal incontinence refractory to conservative management. the investigators will measure the impact of fmt on change in symptom severity and quality of life and stool microbial diversity at 4 and 12 weeks after fmt.

Eligibility criteria:
inclusion criteria: * women 50 years of age and older with self-reported fecal incontinence defined as: * uncontrolled bothersome loss of liquid or solid fecal material that occurs at least weekly over the last 3 months and * failure of response to conservative management using fiber, diet modification, supervised pelvic floor exercises * baseline st. mark's score of greater than or equal to 12 * intolerance, unwillingness or inadequate response to constipating medications * self-reported current negative colon cancer screening based on the 2016 us preventive services task force recommendation (applies to participants age 50-75). n/a if participant is over 75 * able and willing to sign the informed consent form and agree with study procedures exclusion criteria: * known food allergy that could lead to anaphylaxis * contraindications to naso-gastric tube placement including: * recent mid-face trauma * history basilar skull fracture * recent ent surgery * known coagulation abnormalities * esophageal varices and/or esophageal strictures * untreated prolapse beyond the hymen * history of inflammatory bowel disease (does not include ibs) * unrepaired rectovaginal fistula/chronic 4th degree laceration * full thickness rectal prolapse * history of congenital anorectal malformation * history of bowel resection surgery for any indication * minor anal procedures within 6 months for treatment of accidental bowel leakage (abl) (injection of bulking agent or radiofrequency energy) or ligation of hemorrhoids * prior pelvic or abdominal radiation * diagnosis of cancer of the descending colon or anus
develop and validate ultrasonic device for osteoporotic fracture risk assessment

Conditions: Osteoporosis; Fracture; Aging

Summary: study to demonstrate that the bone ultrasonic scanner (buss) can aid in detection of osteoporosis and predict prevalent osteoporotic fractures. measurements derived from the buss parameters will be able to discriminate between postmenopausal women with osteoporotic fractures when compared to matched controls without history of osteoporotic fracture.

one of several studies to develop and clinically validate a novel ultrasonographic device, buss, for the assessment of osteoporosis and fracture risk.

Eligibility criteria:
inclusion criteria: * postmenopausal women with osteoporotic fracture at spine or wrist * postmenopausal women no history of fracture at spine or wrist exclusion criteria: * women with a history of metabolic disease * stroke * tibia fracture or surgery * bmi ≥ 35 kg/m2 * teriparatide use currently or within the past 6 months, * any skin issues (open wounds or rashes, and/or skin infections) of the tibial area.

Keywords: osteoporosis fracture risk aging tibia sonometer ultrasound bmd bone mineral density dxa 3d-hrpqt waveform profiles
first line treatment of metastatic colorectal cancer with mfolfox6 in combination with regorafenib

Conditions: Colorectal Neoplasms

Summary: this is a study to evaluate the efficacy (effectiveness) and the safety of regorafenib when given in combination with chemotherapy mfolfox6 as first line therapy in patients with metastatic colorectal cancer (crc). mfolfox6 is an approved chemotherapy. regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. a kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. by specifically targeting these proteins, regorafenib may stop cancer growth. the growth of the tumor may be decreased by preventing these specific proteins from functioning. the primary endpoint (the most meaningful result to be tracked) of this study is based on the rate of response, i.e. the disease getting smaller. the aim is to show that the therapy of colorectal cancer with mfolfox6 in combination with regorafenib improves the response rate observed for the standard therapy only.


Eligibility criteria:
inclusion criteria: * male or female subjects aged ≥ 18 years * histological or cytological documentation of adenocarcinoma of the colon or rectum * suitable to receive mfolfox6 regimen as first line metastatic treatment * at least 1 measurable lesion as per recist version 1.1 * unresectable or unlikely becoming resectable metastatic disease * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy of at least 3 months * adequate bone marrow, liver, and renal function exclusion criteria: * prior systemic anticancer therapy for metastatic colorectal cancer (crc). adjuvant chemotherapy for crc (stage i, ii, iii) is permitted, if the adjuvant therapy ended \> 6 months before screening and recurrent disease was documented. * prior treatment with antivascular endothelial growth factor (anti-vegf) agents and any signal transduction inhibitors (stis) * uncontrolled hypertension * subjects with symptoms, signs, or history of brain metastases * any hemorrhage or bleeding event ≥ common terminology criteria for adverse events (ctcae) grade 3 within 4 weeks of start of study treatment * sensory neuropathy (\> ctcae grade 1), unresolved toxicity \> ctcae grade 1 attributed to any prior therapy/procedure excluding alopecia
daily nevirapine to prevent mother to infant transmission of hiv

Conditions: HIV Infections

Summary: infants who are breast-fed by hiv infected mothers have an increased risk of becoming infected with hiv. standard therapy for the prevention of hiv infections in infants included zidovudine (zdv) prior to the onset of labor, a single dose of nevirapine (nvp) for women during labor, and a single dose of nvp for newborns given 72 hours after birth. this study will determine if giving low dose daily nvp to breastfed infants of hiv infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing hiv infections in these infants.

this study will evaluate the safety and effectiveness of adding daily infant nvp to standard prevention measures to decrease vertical transmission of hiv. according to current statistics from the study site, approximately 70% of the pregnant hiv infected women in this study will have begun antenatal zdv prior to the initiation of nvp at labor. the remaining 30% of the hiv infected women enrolled in this trial will have been previously undiagnosed. these women will be diagnosed with hiv infection either at the time they present to the delivery room in stage 1 of labor or immediately postpartum if they present for delivery late in labor and cannot provide informed consent for hiv screening prior to delivery. all infants will receive the standard does of nvp at 72 hours postpartum. infants will then be randomized to receive either daily nvp and a daily multivitamin (mvi) or a daily mvi alone. infants will take nvp/mvi or mvi alone during weeks 2 to 6 postpartum. the primary outcome measure is infant hiv infection rates at 6 months. two additional related cohorts of women will be followed for comparison: 1) an equal number of hiv uninfected women and their children will be enrolled for comparison of postpartum morbidity and mortality; and 2) consenting hiv infected women and their children who choose not to enroll in the clinical trial or are ineligible because they are not breastfeeding will be enrolled in an ancillary cohort.

Eligibility criteria:
inclusion criteria for pregnant or postpartum mothers * hiv infected * planning to breastfeed * able to tolerate oral drugs and available for 12 months of postpartum follow-up exclusion criteria * significant physical or emotional distress * infant with serious or life threatening disease or severe fetal abnormality * obstetrical complications affecting maternal health * prior antiretroviral drugs (except antenatal zdv or intrapartum (nvp)

Keywords: nevirapine pregnancy maternal to infant transmission infant breastfeeding hiv seronegativity
a virtual navigation intervention to reduce behavioral health admissions from rural emergency departments

Conditions: Depression; Anxiety; Substance Use Disorders

Summary: this research project is a pragmatic, randomized evaluation of a quality improvement initiative which seeks to evaluate the effects of standardizing the use of a bh-vpn program among patients with a telepsychiatric consult. the outcomes evaluation of this intervention has been designed to integrate with routine care and minimize frontline staff burden by deploying an evaluation in a real-world setting.

hospital admissions are common amongst those with mental illness. significant morbidity exists for patients who are being admitted to a psychiatric hospital from the emergency department (ed).additionally, commitment to a hospital setting may have adverse effects on patients psychologically, degrade relationships with therapists, and disrupt continuity of care. ed providers often decide to admit to a psychiatric hospital because of limited availability of behavioral health resources. to better enhance transitions of care for those with mental illness, atrium health has designed a behavioral health virtual patient navigation (bh-vpn)program that helps coordinate services and follow-up care, while facilitating the safe discharge of patients. patients presenting to an ed that have a tele psychiatric consult who are recommended for discharge are eligible for services. the behavioral health service line is expanding the program to additional rural emergency departments. using an outcomes evaluation, the investigators will inform atrium health on the effect of the bh-vpn program to reduce hospital admissions among patients with a tele psychiatric consult in the ed. the proposed hypothesis is that by having the bh-vpn program available in an ed, more patients will be discharged from the ed than admitted.

Eligibility criteria:
inclusion criteria: eligible patients must meet each of the following criteria: * present to an ed at participating sites * complete a telepsychiatric consult as captured in the electronic medical record * complete a telepsychiatric consult during the navigator's hours of operation * ≥ 18 years of age at time of ed admission exclusion criteria:• patients currently enrolled in the bh-vpn program upon their index ed encounter -
the arise study - use of vertical positioning

Conditions: Acute Respiratory Distress Syndrome

Summary: the pilot study will randomize 40 ards patients who if proning were required would be randomized to upright bed positioning or to stand of care with bed in the head of bed elevation position

patients will be randomized to receive either daily upright bed positioning or to receive standard of care with head of bed elevated.

Eligibility criteria:
inclusion criteria: - acute respiratory distress syndrome exclusion criteria: * cancer * active tracheostomy

Keywords: bed position
internal carotid artery blood flow in pediatric moyamoya patients

Conditions: Carotid Artery, Internal

Summary: little is known about how general anesthesia-induced decrease in cerebral blood flow in pediatric moyamoya pateints. we investigated this question in patients undergoing moyamoya surgery, hypothesizing that cardiorespiratory changes during this procedure would reduce cerebral perfusion.


Eligibility criteria:
inclusion criteria: * pediatric patients undergoing encephaloduroarteriosynangiosis surgery for moyamoya disease exclusion criteria: * cutaneous lesion on the neck
tolerability of enecadin (inn) in acute ischemic stroke trial - test

Conditions: Stroke

Summary: the main objective of this study is to investigate the tolerability of enecadin in patients with acute ischemic stroke. furthermore, the pharmacokinetics of enecadin in both male and female patients with acute ischemic stroke will be assessed. efficacy trends will be evaluated up to day 30 post stroke.

in the acute stage of ischemic stroke, an ischemic core characterized by a marked decrease in blood flow is present, leading to irreversible neuronal damage at an early stage. around the boundary of the ischemic core, there is a region called ischemic penumbra in which functional recovery is possible after recirculation of blood flow within several hours after the onset, even though the blood flow is markedly decreased. prevention of nerve cell death in the ischemic penumbra by neuroprotective therapy should greatly improve outcome and prognosis of acute ischemic stroke.

Eligibility criteria:
inclusion criteria: * patients with acute ischemic stroke (scoring 3-20 on the national institutes of health stroke scale \[nihss\]) with level of consciousness score: 0 or 1 (conscious patients) are eligible to be treated within 9 hours of onset of stroke symptoms. * for female patients: post-menopausal or surgically sterile (post-menopausal: age ≥55 years and last menses ≥3 years ago). exclusion criteria: * participation in any investigational study in the previous 30 days. * patients unable to understand trial related information. * history or evidence of severe heart diseases further specified in the protocol. * history or evidence of additional diseases or results of baseline visit as specified in the protocol. * use of concomitant and prior medications as defined in the protocol.

Keywords: acute ischemic stroke
a study to evaluate and compare injections of autologous dermal and epidermal cells into the balding scalp of subjects with hair loss

Conditions: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness

Summary: evaluate the ability of injections of ji gami(tm) and ji gami(tm) do to induce hair growth in male and female subjects with hair loss.


Eligibility criteria:
inclusion criteria: * male and female volunteers 18 to 65 years old, inclusive * hair loss consistent with ≥ grade iii-vertex, iv, va, v, and vi, based on norwood-hamilton scale providing there is bridging of hair in the anterior edge of the vertex circle. * have no clinically significant disease or abnormal laboratory results taken at the screening visit. exclusion criteria: * known sensitivity to dmem/f-12 or any component of the study material. * known hypersensitivity to clindamycin hydrochloride, amphotericin b or streptomycin sulfate. * subjects who have used minoxidil, or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening. * a history of drug or alcohol abuse within 1 year of study enrollment. * clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator. * any clinically significant abnormal laboratory parameters. * a positive result at screening for human immunodeficiency virus (hiv 1 or 2), hepatitis b or c, htlv i/ii. * dermatologic condition in donation and/or study areas. * prior surgery in the treatment area. * insufficient hair or scarring in the donor area that might impact cell growth. * any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.

Keywords: androgenetic alopecia male pattern baldness female pattern baldness hair loss baldness