Kornimate/medical-research-clean huggingface dataset:
hsv oral reactivation in children

Conditions: HSV-1; HIV

Summary: in the proposed study, the investigators will carry out novel research to evaluate both symptomatic and asymptomatic daily oral herpes simplex virus (hsv) shedding rates and copy number in children with and without hiv. study objectives: 1. to evaluate the frequency of oral hsv reactivation in hiv-infected and uninfected children secondary objectives: 2. to determine the acceptability of performing daily oral swabs in children age 3-12


Eligibility criteria:
inclusion criteria: * age \> 3 and ≤12 years old * parental/guardian consent and children's assent must be obtained and participants and parent/guardian must be able to comply with study procedures * for hiv-infected group: positive hiv serology by either elisa x 2, elisa + wb or pcr testing exclusion criteria: * age \ 12 years old * acute illness which by opinion of the investigator makes enrollment in the trial unfeasible (including active tuberculosis, malaria or other opportunistic infection requiring treatment) * co-enrollment in other therapeutic/intervention trials (observational trial enrollment is permitted). * stable co-administration of other medications is permitted (e.g. bactrim) * for hiv-infected children; receiving or eligible for antiretroviral (art) therapy by local standards
urinary creatinin/protein ratio in preterms

Conditions: Preterm Infant; Renal Failure

Summary: from the first days of life, the newborn presents a "physiological" proteinuria explained by the coexistence of a glomerular and tubular immaturity, all the more marked as the gestational age (ga) is weak. in the child term, proteinuria decreases the first month and its persistence is the marker of kidney damage. the persistence of proteinuria in preterm infants is also considered a marker of renal impairment; however, neither the "physiological" values nor the pattern of urinary excretion of proteins in the first month of life are known. the proteinuria / creatininuria ratio is a validated indicator of proteinuria, as it is correlated with 24-hour urine proteinuria.


Eligibility criteria:
inclusion criteria: * premature gestational age at birth superior or equal to 32 week of amenorrhea hospitalized in the intensive care unit or neonatal intensive care unit of the university hospital of reunion, southern site, saint pierre, in the first 24 hours of life * informed consent form legal representant exclusion criteria: * renal malformation known in antenatal
an integrative model for palliative care in end-stage liver disease

Conditions: End Stage Liver DIsease

Summary: the purpose of this research study is to understand the impact of palliative care in esld on quality of life, emergency room or hospital visits, and on care provider burden, and to work to develop the best way to provide palliative care in esld.

patients with end-stage liver disease (esld) have multiple symptoms that impact their quality of life and result in more emergency room and hospital visits. palliative care is a medical model that can help alleviate pain and suffering and reduce need for urgent medical care and can do so while continuing other appropriate medical care. while palliative care consults are used in those with esld, despite the pain and suffering that accompanies esld, palliative care is often used too little and too late.

Eligibility criteria:
inclusion criteria: primary participant: * admission for decompensated cirrhosis, age ≥ 18 * willingness to sign consent * able to read and understand english * presence of decompensated cirrhosis with portal hypertension (jaundice, ascites, he, hepatohydrothorax, aki, hrs and/or variceal bleeding) or hcc caregiver: * identified as the primary caregiver of the participant * age ≥ 18 * willingness to sign consent * able to read and understand english exclusion criteria: primary participant: * prior liver transplant * lack of capacity to provide informed consent (in the judgement of the investigator) * already in receipt of palliative or hospice care * those who are likely to receive a lt during the index admission caregiver: • none
evaluation of rapid maxillary expansion facilitated by micro-osteoperforation in adolescent patients with skeletal maxillary constriction

Conditions: Posterior Crossbite

Summary: the aim of this study is to evaluate and compare the effect of rapid maxillary expansion with and without microosteoperforation in patients with skeletal maxillary constriction.theoretically, the force generated by the activation of the hyrax expander leads initially to the compression of the periodontal ligament, bending of the alveolar bone, and tipping of the anchor teeth. this in turn contributes to the unfavorable changes in the supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone thickness, marginal bone loss and alveolar bone fenestration and dehiscence. in this trial, it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation (mop), the alveolar bone bending and buccal tipping that usually occur during expansion will be reduced and thus facilitating the bone expansion.

the study consists of 2 groups that are divided divided equally and randomly.the first group will receive a tooth borne hyrax expander supported on first premolar and first permanent molar , whereas the second group will receive the same appliance associated with microosteoperforation(mop). the mop will be performed on the buccal segment bilaterally along the maxilla starting from the distal of the canine till the distal of the first permanent molar. the assessment will be done using cbct scans immediately after expansion and 6 months postretention.

Eligibility criteria:
inclusion criteria: * female adolescent patients with an age range 11- 14 years. * having apical constricted maxillary arch reflected by posterior cross-bite and verified through howe's analysis on the dental study models. * normal vertical growth pattern. * fully erupted maxillary first premolars and first permanent molars. exclusion criteria: * previous orthodontic treatment. * any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement. * active periodontal affection or severe gingival inflammation.
predictors of health service utilizations among key population in washington dc

Conditions: Pre-exposure Prophylaxis; HIV; Health Behavior

Summary: the primary objective of the proposed study is to investigate how prep use might result in an increase in the utilization of health and social services offered at a local community-based organization. our primary hypothesis is that the investigators will observe higher utilization of sexual health (sti screenings), psychosocial health (psychotherapy, and substance use treatment) and other social services (emergency cash assistance, food pantry, transportation assistance, clothing,and housing resources) among prep users (lai-prep or daily oral) compared to participants who are prep naïve over the 12-month follow-up period.


Eligibility criteria:
inclusion criteria: * age of 18 years or above; * confirmed hiv-negative status; * residence in the washington, dc metropolitan area; * one of the following prep profiles (prep naïve \[no history of any prep use in the past\] currently on daily oral prep or receiving lai-prep). exclusion criteria: * being younger than18 years of age * being unable to speak and/or read english * a reported residence outside of the defined washington, dc metropolitan area * being unable or unwilling to provide written informed consent * being unable to comply with the requirements of the protocol (i.e. persons with mental health conditions, persons who are intoxicated or incoherent for other reasons) * evidence of suspected hepatoxicity
a study of changes in ki67 expression in people with breast cancer receiving endocrine therapy before surgery

Conditions: Breast Cancer

Summary: the researchers are doing this study to look at changes in ki67 expression after at least 2 weeks of endocrine therapy in people with er+/her2- breast cancer undergoing cancer removal surgery. participants will receive the endocrine therapy before their surgery. the researchers will look at how changes in ki67 expression compare between participants who are carriers of the brca2 mutation and participants who are noncarriers of the brca2 mutation.


Eligibility criteria:
inclusion criteria: * postmenopausal women aged ≥18 years with biopsy-proven stage i-iii invasive breast cancer that is er+/her2- * scheduled to undergo upfront surgery * eligible for genetic testing in accordance with national comprehensive cancer network guidelines exclusion criteria: * history of breast cancer * receipt of et for risk reduction in the previous 3 months * stage iv disease at presentation * scheduled to undergo neoadjuvant systemic chemotherapy * pregnant

Keywords: ki67 expression brca2 mutation er+/her2- endocrine therapy 23-311
combined ldr boost and hdr whole gland

Conditions: Carcinoma Prostate

Summary: this is a dose finding phase i/ii study of combined focused ldr brachytherapy boost with whole gland single fraction hdr for men with low and intermediate risk prostate cancer and dominant intraprostatic lesion (dil) visible on multi parametric mri. patients will receive 19 gy hdr to the whole gland with concurrent ldr brachytherapy boost to the dil, in a sequential dose escalation manner. primary endpoints are early toxicity.

eligible patients will have low and intermediate risk prostate cancer with a dominant intraprostatic lesion definable on multi parametric mri (pirads 4 or 5). patients will have mr planned ldr focal brachytherapy to the dil using iodine-125, while at the same time have single 19 gy delivered to the whole prostate using ultrasound directed high dose-rate brachytherapy (hdr). the ldr boost dose will start at 50 gy, and increase dil dose in sequential cohorts of patients up until a dose of 80 gy. up to 20 patients will be included. primary endpoint is toxicity at 3 months.

Eligibility criteria:
inclusion criteria: * confirmed adenocarcinoma of the prostate * single pirads 4 or 5 lesion on multiparametric mri * t1c-t2b on rectal exam * gleason 3+3 and psa \< 20ng/ml * gleason 3+4 and psa \<10ng/ml * less than 50% of the cores positive in an untargeted prostate biopsy. * prostate volume \< 60 cc exclusion criteria: * incapable or ineligible for mri imaging * previous trans-urethral resection of prostate (turp) * previous or current use of androgen deprivation * baseline international prostate symptom score (ipss) \> 15 * evidence of distant or nodal metastasis * disease that contraindicates treatment with radiation (e.g connective tissue disease) * unsuitable for anesthesia due to comorbidity

Keywords: brachytherapy ldr hdr monotherapy focal
effect of emotional freedom technique on symptoms in dysmenorrhea

Conditions: Woman; Pain

Summary: 1. reducing symptoms with eft in young women suffering from dysmenorrhea 2. improving the quality of life of young women suffering from dysmenorrhea 3. raising women's awareness for eft 4. reducing healthcare costs for dysmenorrhea

primary dysmenorrhea, the most common form of dysmenorrhea, is a problem characterized by pain that begins in the lower abdomen before or with menstruation, lower back pain and pain radiating to the legs. the emotion freedom techniqu has become a manualized method that has led to uniform application research, education, and clinical practice. eft is a brief intervention that combines exposure, cognitive therapy, and somatic stimulation of acupressure points on the face and body. it has been reported in the literature that eft, a "needle-free and emotional" form of acupuncture, reduces or eliminates dysmenorrhea symptoms and premenstrual complaints.

Eligibility criteria:
inclusion criteria: * • being a female student at karabük university faculty of health sciences * being between the ages of 18-25 * voluntarily agrees to participate in the study, * t.r. to be a citizen, * not having any chronic disease, * those whose symptom complaints are 5 or above according to the vas scale exclusion criteria: * • leaving the study at any time, * having any diagnosed psychiatric disorder. * not having secondary dysmenorrhea pathology

Keywords: dysmenorrhea woman quality of life
vivatmo protm eu-study: feno monitoring in asthmatic patients responding to ics treatment

Conditions: Asthma

Summary: this is a multi-center study to evaluate fractional exhaled nitric oxide (feno) measured with the vivatmo pro in adult and pediatric subjects.

subjects will be screened, enrolled and tested at study visit #1 and then prescribed inhaled corticosteroid (ics) treatment as per routine clinical care. subjects will return for study visit #2 in two weeks and repeat fractional exhaled nitric oxide (feno) measured with the vivatmo pro,

Eligibility criteria:
inclusion criteria: 1. subject is 7 to 80 years of age. 2. has asthma 3. has been identified as a candidate for inhaled corticosteroid (ics) treatment 4. is willing and able to perform vivatmo pro™ testing exclusion criteria: 1. subject has used corticosteroids prior to enrollment. 2. subject has other current serious medical conditions 3. subject has not been clinically stable for at least 2 weeks prior to the study 4. subject is unwilling or unable to perform vivatmo pro testing
efficacy and safety of insulin glulisine in type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: * to evaluate non-inferiority in the efficacy of hmr1964 as compared with insulin lispro in terms of the change in hba1c from baseline to endpoint. * to compare the safety of hmr1964 with insulin lispro.

* to compare hmr1964 with insulin lispro in terms of the change in hba1c from baseline to week 12 and week 28; consecutive change in hba1c by every 4 weeks, blood glucose parameters, symptomatic hypoglycemia and insulin doses (rapid-acting, basal and total). * to collect 6-month safety data of hmr1964.

Eligibility criteria:
inclusion criteria: * men or women with type 1 diabetes mellitus, an hba1c range of \>=6.0 - =\<11.0%, and on a basal-bolus insulin regimen. they must have had at least 1 year of continuous insulin treatment at the date of informed consent. exclusion criteria: * subjects who received an oral hypoglycemic agent other than insulin within 4 weeks prior to informed consent * subjects who received oral or intravenous corticosteroid within 4 weeks prior to informed consent * subjects who were treated with another investigational product within 12 weeks prior to informed consent * subjects with likelihood of requiring concomitant treatment during the study period with drugs not permitted by this study protocol * subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, other serious complication or systemic disease making implementation of the protocol or interpretation of the study results difficult * subjects who have undergone pancreatectomy or pancreas/islet cell transplant * night shift workers * subjects unlikely to comply with the study protocol, e.g., inability to periodic return for follow-up visits, and unlikelihood of completing the study * subjects who have previously been treated with hmr1964 * subjects who are pregnant, breast feeding or wish to become pregnant during the study period * female subjects who are possibly pregnant \[female subjects of reproductive potential who have serum human chorionic gonadotropin (hcg) level \> 0.7 miu/ml as determined by central laboratory, srl medisearch inc., during screening phase\] * subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 24 weeks prior to informed consent, or who are expected to have these surgical treatments during the study period * subjects with history of alcohol abuse * subjects with hypersensitivity to insulin preparations * subjects with impaired hepatic function (sgot or sgpt ³=\<80 iu/l determined by central laboratory, srl medisearch inc., during screening phase) or impaired renal function (serum creatinine =\<2.0 mg/dl determined by central laboratory, srl medisearch inc., during screening phase) * subjects who are judged by the investigator or subinvestigator as inappropriate as the subjects of this study for any other reason

Keywords: hmr1964, insulin glulisine, diabetes mellitus, type 1
prevalence of aspirin resistance in chronic kidney disease patients

Conditions: Chronic Kidney Disease

Summary: the primary objective of the study is to determine the prevalence of aspirin resistance in chronic kidney disease patients. the secondary objectives are to determine possible risk factors contributing to aspirin resistance in this population.

a cross-sectional of "aspirin resistance in hemodialysis patients" previously done in our institution showed that 23/66 (34.7%) hemodialysis patients were aspirin resistant. in a recent systematic review, renal impairment was associated with aspirin resistance . this association was seen in only two out of the twenty studies used in this meta-analysis . both these studies are from the same center with a predominant asian population. in this study we will try to evaluate the prevalence of aspirin resistance in ckd patient without being limited to a specific ethnicity.

Eligibility criteria:
inclusion criteria: * patients with known structural kidney disease as evident by history or by urinalysis and ckd stage iii or iv determined by mdrd formula and who are taking aspirin. exclusion criteria: * younger than 18 years of age. * bleeding disorder or myeloproliferative disorders. * thrombocytopenia with platelets \< 100.000. * malignancy. * acute hemorrhagic disease. * a recent history of receipt of platelet glycoprotein iib/iiia blockers. * liver disease as evident by abnormal liver function and total bilirubin \> 2mg/dl. * use of anticoagulation.

Keywords: aspirin chronic kidney disease
assessment of elderly undergoing allogeneic hematopoietic stem cell transplantation

Conditions: Stem Cell Transplant

Summary: patients older than 60 years are more and more transplanted. comprehensive geriatric assessment (cga) have been developed and are currently used in patients with cancer, it has been correlated with the prognosis. there is still few data in transplanted patients and the aim of this study is to assess these patients before and after transplantation in order to monitor their general health and quality of life (qof) and correlate them to the prognostic.


Eligibility criteria:
inclusion criteria: * 60 years or more at time of transplantation * patient receiving a hematopoietic stem cell allograft for myeloid hemopathy (myeloid acute leukemia, myelodysplastic syndrome, myeloproliferative neoplasm) or for an acute lymphoblastic leukemia * no opposition to participate exclusion criteria: * patient opposed to the protocol * vulnerable patients protected by curatorship or administrative supervision * patients not covered by a social security scheme
breast reconstruction with external pre-expansion and autologous fat transfer versus standard therapy

Conditions: Breast Cancer

Summary: this multicentre randomized controlled trial aims to evaluate a new breast reconstruction technique- autologous fat transfer (aft). female patients with breast cancer schedule to receive a mastectomy (or having undergone mastectomy in the past) will be randomized to undergo breast reconstruction with either aft (intervention group) or reconstruction with implants (control group). aft will be evaluated in terms of quality of life, aesthetic result, complications, oncological safety and cost-effectiveness.


Eligibility criteria:
inclusion criteria: * female gender * age of 18 years and older * history or in candidate for a mastectomy procedure in the near future * patients' choice to undergo a breast reconstruction * wanting to participate in this study * patient is able to wear the brava device exclusion criteria: * active smoker or a history of smoking 4 weeks prior to surgery * current substance abuse * history of lidocaine allergy * history of silicone allergy * 4 weeks or less after chemotherapy * history of radiation therapy in the breast region * oncological treatment includes radiotherapy after mastectomy * kidney disease * steroid dependent asthma (daily or weekly) or other diseases * immune-suppressed or compromised disease * uncontrolled diabetes * bmi\>30 * large breast size (i.e. larger than cup c), unless the patient prefers reduction of the contralateral side towards cup c * extra-capsular silicone leaking from the encapsulated implant from a previous breast reconstruction * the treating plastic surgeon has strong doubts on the patient's treatment compliance * claustrophobia for an mri-scan

Keywords: fat grafting fat injection lipoaspirate fat transfer lipofilling liposculpturing lipoinjection lipotransfer breast reconstruction external pre-expansion brava eve
evaluation of the percutaneous scs trial using the dssep collision testing

Conditions: Back Pain With Radiation

Summary: this study is to objectively evaluate the success of a spinal cord stimulator (scs) trial using testing (dssep) to determine if the paresthesia (tingling sensation) or pain reduction achieved correlates with the degree of stimulation.

the scs trial leads will be placed as per standard of care, using fluoroscopic guidance and leads will be checked for proper positioning. leads will be tested for appropriate paresthesia coverage of the patient's painful area(s), using multiple electrode configurations and lead positions (dependent on the location of the pain). after the leads are secured, the patient will be sent to the recovery room where the dssep test will be performed. a technologist will glue/tape recording electrodes to the patient's head, neck, back or legs. one or two stimulating electrodes are also placed on the patient's leg. each electrode is checked with a meter to ensure proper functioning. pulsing stimulus will start in one of the stimulating electrodes. each time a different area is tested, the pulsing will be started again. each area tested will take 10-15 minutes. the painful dermatomal distribution area, specific to each patient will be used for dermatomal ssep stimulation. placement will be correlated with nerve roots involved with the corresponding dermatomes. measurements will be obtained to determine collision criteria.

Eligibility criteria:
inclusion criteria a subject will be eligible for inclusion in this study only if all the following criteria apply: a. subject understands the procedures, agrees to participate in the study, and has signed and dated the informed consent form prior to the initiation of any study-related activities. b. subjects are male or female greater than 18 years old at the time of screening visit. c. pain in one or both lower extremities. d. pain is not responding to conservative treatment such as physical therapy or medications. e. average pain rating of at least 4 on a scale 0 to 10, on average, prior to enrollment in the study. f. patient is mentally competent to make decisions. exclusion criteria a subject will not be eligible for inclusion in this study if any of the following criteria apply: a. female subject with childbearing potential (a premenopausal female, who is not surgically sterile). b. subjects who poorly cooperate or have any cognitive impairment. c. patient with severe concomitant depression. d. inability to communicate adequately with physician and /or study coordinator. e. patient is diagnosed with a psychiatric condition that will likely interfere with diagnostic accuracy of the workup protocol or with recovery following the anticipated procedure

Keywords: lumbago low back pain leg pain