Kornimate/medical-research-clean huggingface dataset:
the effect of gender on antidiuresis - evaluated by graded low dose desmopressin infusion

Conditions: Gender Difference in V2 Receptor Function in Response to dDAVP Infusion; Nocturia; Nocturnal Enuresis

Summary: there is substantial evidence that women throughout life have significantly lower plasma levels of the antidiuretic hormone vasopressin (pavp) compared to men. the importance of this is not yet fully elucidated, but in relation to the observations of lower pavp levels, no significant difference in renal response parameters was found. this could be interpreted an increased renal sensitivity in females compared to males. the theory of increased renal sensitivity in females is supported by a few pharmacodynamic studies currently available on this topic. however none of the studies was designed with the purpose of investigate the gender difference. the aim of this study is to investigate possible gender differences in the renal sensitivity to ddavp and the effect of age on these differences. this will be done by low dose graded infusion of the synthetic avp analog ddavp. participants are 80 healthy volunteers equally distributed between four age groups, 8-10 years of age, 16-18 years of age, 25-40 years og age and 65+ years of age.


Eligibility criteria:
inclusion criteria: * healthy * normal clinical examination * normal residual urine measurements * normal urine dip stick * informed consent by participant or legal guardian exclusion criteria: * smoking, alcohol or drug abuse * conditions of importance to the results (endocrinological, renal or cardial) * current or previous history of incontinence, bedwetting or nocturia * drug use of importance (diuretics, hormone replacement therapy, birth control pills, desmopressin) * pregnancy * allergy towards ddavp/desmopressin
artificial intelligence (ai) validation study for polyp detection

Conditions: Polyp of Colon

Summary: interventional prospective multicenter study: polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy

this is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (cad) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (adr \> 20% and \< 50%) while a second observer will follow the procedure on a bedside ai-tool to count the number of detections made by the ai system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. when a doubtful detection is made by the ai-system, the second observer will ask to re-evaluate the indicated region. when the detection is clear, the endoscopist and second observer do not communicate. the entire procedure is recorded.

Eligibility criteria:
inclusion criteria: * \> 18 years * diagnostic or screening colonoscopy * therapeutic colonoscopy exclusion criteria: * inability to give informed consent by the patient or legal representative * \< 18 years old * any contraindication for colonoscopy or biopsies of the colon * uncontrolled coagulopathy * confirmed diagnosis of inflammatory bowel disease * short bowel or ileostomy * pregnancy

Keywords: colonic polyp artificial intelligence second observer
evaluation of use of plastic bags to prevent neonatal hypothermia-part v

Conditions: Hypothermia; Newborn

Summary: the overall hypothesis is that plastic bags used in combination with who thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine who thermoregulation care alone. part v is comparing standard who thermoregulation practices plus use of a plastic torso wrap to no plastic torso wrap in full term infants from resuscitation to one hour after birth.

due to delivery rooms without adequate climate controls, even full term infants have high rates of hypothermia in the developing world. this study will compare the rates of hypothermia one hour after birth in full term infants randomized to receive standard who thermoregulation care (control group) or standard who thermoregulation care without immediate drying plus a plastic bag covering their torsos and lower extremities (intervention group). the axillary temperature of each infant will be taken within 15 minutes of birth at at one hour after birth with removal of the plastic bag. hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. with an estimated baseline hypothermia rate of 15% and a hypothesized 10% absolute risk reduction (66% relative risk reduction), a sample size of 276 will be used to have a power of 80% and a confidence interval of 95%.

Eligibility criteria:
inclusion criteria: * estimated gestational age 37 weeks and greater * birth weight greater than 2,500gms * delivery in the hospital exclusion criteria: * infant admitted to the nicu * birth weight less than 2,500gms * abdominal wall defect or myelomeningocele * major congenital anomalies * blistering skin disorder

Keywords: hypothermia newborn plastic bag resuscitation
study to evaluate safety and efficacy in adult subjects with itp

Conditions: Immune Thrombocytopenic Purpura

Summary: the purpose of this study is to assess the safety and tolerability of bms-986004 when administered in subjects with itp.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * ≥18 years old, diagnosed with persistent or chronic itp exclusion criteria: * secondary immune thrombocytopenia * drug induced thrombocytopenia
game changers for cervical cancer prevention

Conditions: Cervical Cancer

Summary: this randomized controlled trial will evaluate game changers for cervical cancer prevention (gc-ccp) for increasing cervical cancer (cc) screening advocacy among intervention recipients (index participants) towards female social network members, and uptake of cc screening among enrolled female social network members (alter participants) who have not previously been screened. the main research questions are: 1. is the gc-ccp network-based peer advocacy intervention superior to usual care (no intervention) in improving uptake of cc screening among alter participants, across urban/rural and public/private clinics? 2. what are the mediators and moderators (among index, alter and network characteristics) of intervention effects on (a) alter cc screening; and (b) engagement in cc prevention advocacy among index participants?

this randomized controlled trial will evaluate game changers for cervical cancer prevention (gc-ccp) for increasing cervical cancer (cc) screening among previously unscreened social network members. the trial will be conducted at 4 study clinics \[2 public, 2 private-not-for-profit (pnfp), one each in an urban and rural location\]. at each clinic, 40 women screened for cc in the past year will be enrolled in the rct as index participants (n=160 index) and randomized to the intervention (in two groups of 10) or wait-list control. the intervention will consist of 6 weekly group sessions that focus on cc stigma reduction, sharing of cc screening experience with others, knowledge of cc facts and myths, and skills building for engagement in cc prevention advocacy with female social network members (1st degree alters). each index will recruit up to three alters (n\~440 1st degree alters) at baseline who have not screened for cc; these index and alter participants will be followed up at months 6 and 12. at month 6, half of the 1st degree alters will be asked to recruit up to female social network members (2nd degree alters) whom they have engaged in cc screening advocacy with; these 2nd degree alters will receive a single phone-based brief interview; at month 12, the other half of the 1st degree alters will be asked to recruit up to two 2nd degree alters for the same purpose.

Eligibility criteria:
inclusion criteria: * screened for cervical cancer in the past year (index participants only) * has shared cervical cancer screening experience with at least one adult female social network member whom is believed to not have been screening for cervical cancer; or she reports that there is at least one female social network member who has not screened and she would feel comfortable disclosing her personal screening experience to her (index participants only) * is a member of social network of enrolled participant (social network member participants only) exclusion criteria: * advanced stage cervical cancer (index participants only) * screened for cervical cancer in the past (1st degree social network member participants only)
diet and exercise in overweight children postburn

Conditions: Obesity; Burns

Summary: examine clinical results of an interdisciplinary weight management program that includes medical evaluation, nutrition counseling, exercise, and behavioral interventions.


Eligibility criteria:
inclusion criteria: * 10-18 years old * bmi \> or = 95th percentile * \> 1 year postburn and out of pressure garments * live within 100 minle radius of shc * informed consent and hippa form signed * parent/guardia willing to make time commitment exclusion criteria: * undergone major surgery in the 4 months prior to start of program or have any major surgery planned in 2 year time frame * physical/health condition that precludes regular exercise * significant mental health diagnosis * advised by md not to exercise * thyroid disease, routine steroid use,pregnancy * unable to understand the instructions/content of program

Keywords: pediatrics
improving measurement and treatment of post-stroke neglect

Conditions: Stroke

Summary: this study examines how to best assess and treat post-stroke neglect. this study will examine the preliminary effects of an innovative intervention (repetitive task-specific practice + transcranial direct current stimulation) for individuals with neglect. this study will also determine whether items from various neglect assessments can be combined to establish a more comprehensive neglect measure.

it is very common for stroke survivors to have difficulty attending to one side of their body or space (neglect). stroke survivors with neglect not only demonstrate impairments in attention but they also experience motor impairment. these individuals also have an imbalance in excitation in the brain. this study will examine the preliminary effects of non-invasive brain stimulation (transcranial direct current stimulation, tdcs) combined with arm rehabilitation training (repetitive task-specific practice, rtp) for individuals with neglect following stroke. the investigators will examine the effects of the intervention on brain excitability, upper extremity motor impairment, and attentional impairment. this study will also examine assessment of neglect. there are many clinical assessments designed to assess neglect; however, it is unknown whether items from some of the most commonly used assessments are able to effectively measure neglect or whether items from these assessments can be combined. clinicians rely on clinical assessments to inform treatment and document patient progress. therefore, it is important that investigators more closely examine these existing assessments.

Eligibility criteria:
inclusion criteria: * ischemic or hemorrhagic stroke 3 months post stroke. * fugl-meyer upper extremity (fma-upper extremity) score between 20-56/60 * inducible motor evoked potential (mep) of the abductor pollicis brevis (apb) on the paretic stimulation (tms) * demonstrate the presence of unilateral neglect (virtual reality lateralized attention test score \<18) exclusion criteria: * history of cortical hemorrhagic stroke * presence of any mri, tms, tdcs risk factors including: * history of seizures * history of brain tumor * hardware in skull or spine (e.g. coils, clips) * implantable medical device (e.g. pacemaker) * metal in body (not compatible with mri) * pregnancy * severe spasticity (modified ashworth scale score 3) * severe aphasia or cognitive impairment limiting participants' comprehension (national institutes of health stroke scale level of consciousness commands item score 1 or best language item score 2) * unable to travel to ue motor function laboratory at the center for rehabilitation research in neurological conditions (a collaborative, mou approved, research center ralph h. johnson va medical center and the medical university of south carolina) for the study

Keywords: perceptual disorders cerebrovascular disorders neurobehavioral manifestations neurologic manifestations neglect non-invasive brain stimulation rehabilitation tdcs paresis
tens unit for analgesia during iud insertion

Conditions: IUD; Analgesia; Patient Preference; Pain, Acute

Summary: subjects will be screened over the phone or in tufts gyn clinic for participation in the study. if eligible and interested in participating, written informed consent (and assent if applicable) will be obtained. after informed consent/assent, the patient will be enrolled in the study. the patient will decide if they desire to use tens unit during iud insertion appointment and inform the study team. the clinic visit will proceed as normal, with additional study proceedings as follows. the study personnel will complete the 'background questionnaire' with the patient prior to iud insertion. during the iud insertion appointment, study personnel will assist in collection of the 'study visit' data collection form. this includes recording the patient's pain score at various time points throughout the insertion procedure: * anticipated pain during iud insertion * baseline pain prior to insertion * speculum insertion * tenaculum placement * paracervical block administration (if performed) * cervical dilation (if performed) * uterine sounding * iud insertion * 5 minutes after iud insertion study personnel will also time the insertion procedure and collect additional data as outlined in the 'study visit data collection form.' after iud insertion, the participant will be asked to complete the 'post-iud insertion survey.' once this survey is complete, this will conclude the study participation. participation will last through the study visit only. as part of the standard of care, a urine pregnancy test will be obtained and confirmed negative prior to iud insertion. patients will receive routine pain management modalities per shared decision-making with their clinical provider which may include nsaid administration, paracervical block, and heating pad.


Eligibility criteria:
inclusion criteria: 1. persons with a uterus desiring insertion of intrauterine device 2. able to provide informed consent/assent 3. age 12-50 years old 4. minors 12 years of age and older will be included in the study if postmenarchal exclusion criteria: 1. unable to provide informed consent/assent 2. prior cervical procedure (ie loop electrosurgical excision procedure, leep) 3. concurrent cervical or intrauterine procedure (ie colposcopy or dilation and curettage) 4. cutaneous damage at the tens electrode sites 5. chronic or pre-procedure use of opioids 6. chronic pain diagnosis 7. prior iud insertion 8. any contraindication to intrauterine device (iud): 1. pregnancy 2. uterine anomaly that distorts the uterine cavity 3. acute pelvic inflammatory disease (pid) 4. postpartum endometritis or infected abortion in the past 3 months 5. unexplained abnormal uterine bleeding 6. wilson's disease or copper allergy (contraindication to copper iud only) 7. breast cancer (contraindication to levonorgestrel iud only

Keywords: iud contraception iud placement pain management teen
y90 radiation segmentectomy vs sbrt for hcc

Conditions: Hepatocellular Carcinoma (HCC)

Summary: the proposed study is a single site, prospective, randomized pilot study to assess the feasibility of recruitment of patients into a trial evaluating the efficacy and tolerability of selective transarterial y90 radioembolization (radiation segmentectomy) versus stereotactic body radiation therapy (sbrt) for solitary early stage (≤ 3cm) hepatocellular carcinoma (hcc).


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and hipaa authorization * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, aged ≥ 18 years at time of informed consent * solitary hcc (≤3 cm) diagnosed by imaging (li-rads 4-5) or histology * childs-pugh score ≤ 7 * ecog performance status 0-1 * tumor location/characteristics eligible for either sbrt or y90 therapy as deemed by local tumor board * adequate organ function defined as: 1. serum bilirubin \< 4.0 mg/dl , 2. albumin \> 2 g/dl exclusion criteria: * any prior locoregional therapy to the target tumor * any prior radiation therapy to the liver * pregnancy or lactation: women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria: i. has undergone a hysterectomy or bilateral oophorectomy; or ii. has been naturally amenorrheic for at least 24 consecutive months * known severe allergic reaction (anaphylaxis) to iodinated contrast * coagulopathy (platelets \ 2) not correctable by transfusion * macrovascular invasion or extrahepatic hcc
comparison of follow-up by mobile app or paper questionnaire of patients undergoing rotator cuff surgery

Conditions: Rotator Cuff Injuries

Summary: this study evaluate if in an outpatient rotator cuff surgery, can the use of mobile app compared to conventional paper questionnaire improve follow-up care in the first 90-days following surgery.

rotator cuff surgery is a painful arthroscopic surgery. in outpatient surgery, the surgeons have to increase the security and surveillance after the surgery to reassure the patient and avoid complications. most patients receiving ambulatory rotator cuff surgery have high pain score, and management and aspects of the rehabilitation can be challenging. however, regular follow-up is still considered important in the early post-operative phase. in between the conventional appointment 6 weeks post op and 12 weeks post op, the surgeons have no status of the patient, and no markers to check if the postoperative care is evolving right. currently, the investigators are using a mobile application (orthense by digikare, blagnac, france) to complement in-person postoperative follow-up care for patients.

Eligibility criteria:
inclusion criteria: * patients undergoing rotator cuff surgery. they must be able to use a mobile-app, and have an email address and internet connexion. exclusion criteria: * unable to read french

Keywords: mobile app rotator cuff outpatient surgery follow-up
a study of abgn-168h in patients with steroid refractory acute graft-vs-host disease after donor stem cell transplant

Conditions: Acute Graft Versus Host Disease

Summary: this study is to establish the safety, determine if there is an improvement in steroid refractory acute graft-vs-host disease (agvhd) compared to historical cohorts, and determine the changes of agvhd-associated t-cell clones in patients with steroid-refractory agvhd following allogeneic hematopoietic cell transplantation administered abgn-168h once weekly for 4 weeks.

abgn-168h is a humanized monoclonal antibody. this is a dose escalation study using a modified toxicity probability interval method. abgn-168h will be administered intravenously (iv) once weekly for four weeks, in patients with steroid refractory agvhd following hematopoietic cell transplant (hct). after completion of study treatment, patients are followed up for 90 days.the primary objective of this study is to establish the safety, and the secondary objectives of this study are to determine if there is an improvement in disease response at 3 months after diagnosis of steroid refractory agvhd compared to historical cohorts and to determine the changes in frequency and/or phenotype of agvhd-associated t cell clones in response to abgn-168h therapy.

Eligibility criteria:
inclusion criteria: 1. diagnosis of skin, gut and/or liver steroid-refractory gvhd by clinical assessment of treating physician following allogeneic hct. patients who fail to respond to steroids by 7 days are considered steroid-refractory 2. previously-treated with any conditioning regimen and any gvhd immune suppression prophylaxis and formulation of steroids, except as noted in exclusion criteria #2. 3. abgn-168h (neihulizumab) therapy can begin not more than 14 days after diagnosis of agvhd 4. karnofsky performance status (kps) \> 50% 5. no evidence of hct graft failure or multi-organ failure 6. ability to understand and the willingness to sign a written informed consent document exclusion criteria: 1. uncontrolled infections not responsive to antimicrobial therapy requiring intensive critical care 2. progressive malignant disease, including post-transplant lymphoproliferative disease unresponsive to therapy 3. treatment with investigational gvhd prophylactic agents (eg, ccr5 inhibitors; lenalidomide; and/or bortezomib) within the 7 days prior to the 1st dose of neihulizumab 4. treatment with other investigational agents within the prior 7 days prior to the 1st dose of abgn-168h (neihulizumab) 5. cmv pcr \> 500 copies/ml or evidence of end-organ damage due to cmv 6. pregnant or nursing 7. hiv positivity (note: patients positive for hepatitis b or hepatitis c are not excluded, and may be evaluated on a case-by-case basis) 8. renal clearance ccr \< 40 ml/min
educational technology to enhance diabetes care - retention study

Conditions: Diabetes Mellitus

Summary: this study mapped the time course of forgetting among resident physicians after they use an online learning exercise covering principles of diabetes care. participants took a pre-test followed by an online tutorial covering aspects of diabetes care. they then completed a post-test on the same topics after a randomly-assigned time delay from 0 to 55 days. we hypothesized that post-test scores after these different time delays would decline following a curvilinear relationship with increasing time. this understanding of forgetting will inform our selection of a time for delivering reinforcement exercises in future educational studies among physicians.


Eligibility criteria:
inclusion criteria: * family medicine residents (physicians in training) * internal medicine residents (physicians in training)