Kornimate/medical-research-clean huggingface dataset:
screening and nutrition for patients with diabetes: a pilot study

Conditions: Diabetes Mellitus

Summary: the goal of this project is to provide diabetes self-management education and support (dsmes) and simultaneously address food insecurity for a high-risk, ethnically diverse adult population who participate in a food pantry. this project will utilize a community-based participatory research model (cbpr). community representatives will engage in project implementation by participating in designing the messaging for cultural impact and advising in study operations. this intervention targets food pantry clients self-reporting a t2dm diagnosis or who screen positive for t2dm through on-site hba1c testing. once enrolled, participants will complete self-paced web-based/mobile dsmes modules, available in english and spanish, that include the adces7 (association of diabetes care and education specialists) self-care behaviorstm. support through text messaging, monthly group sessions, and peer mentorship will be facilitated by nursing students, registered dietitian nutritionists (rdns), and diabetes care and education specialists (dces) for 12 weeks. participants will receive nutritious food from the pantry consistent with dietary guidelines for diabetes.

eligible patients who agree to participate in the study will be screened for diabetes via hba1c fingerstick measurement. participants will receive diabetes self-management education, food items recommended by registered dietitians, peer support, monthly in-person group support sessions held at the foot pantry, and text messaging with continued education. data will be collected at intake. follow up data will be collected 90 days after enrollment.

Eligibility criteria:
inclusion criteria: * age 18 and older * existing and/or new diagnosis of t2dm * food pantry participants * english and/or spanish speaking * willing/able to provide informed consent * must have a mobile device able to receive text messages exclusion criteria: * under the age of 18 * no t2dm or do not meet hba1c \> 6.5 criteria * not a food pantry participant * unwilling/unable to provide informed consent * spoken language is other than english/spanish * individuals who do not have access to a mobile device or are unable to receive text messages

Keywords: food insecurity community based participatory research education
specimen collection study for h. pylori testing

Conditions: Helicobacter Infections

Summary: the objective of this study is to acquire human specimens from subjects undergoing routine endoscopy with gastric biopsy for the diagnosis of active h. pylori infection.

this is a prospective study designed to acquire and bank human specimens from subjects who are scheduled for routine upper endoscopy for symptoms such as dyspepsia. this study will be conducted at a minimum of 2 sites in the united states. investigator sites will enroll prospective subjects who meet the inclusion / exclusion criteria. a case report form (crf) provided by the sponsor will be used to capture basic demographic information (dob, age, gender, race/ethnicity), medication history, and related clinical information. the crfs will also record the results of the following tests performed with the gastric biopsy tissue specimens: histology and rapid urease test (rut).

Eligibility criteria:
inclusion criteria: * aged 21 and to 75 years. * able to read, speak, and understand english or have access to a translator in subject's native language. * patients without prior h. pylori eradication treatment. * currently not on proton pump inhibitors, antibiotics or bismuth * discontinuation at least 2 weeks prior to endoscopy and specimen collection. * present with signs and symptoms of dyspepsia \[e.g. upper abdominal discomfort or pain\] * undergo gastric biopsies as part of routine care * physician able to provide histology and rapid urease result on biopsy specimens. exclusion criteria: * aged less than 21 years old or older than 75 years * unable to provide consent. * patients with a history of prior h. pylori eradication therapy. * currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not discontinue * previous upper gastrointestinal surgery, such as bariatric surgery, nissen fundoplication, or roux-en-y. * any unstable or poorly-controlled medical or psychiatric condition.
nicotinamide mononucleotide in hypertensive patients

Conditions: Hypertension

Summary: cardiovascular and cerebrovascular diseases are most terrible killers endangering the health of chinese residents, and hypertension is the most important risk factor. hypertension related vascular function and structural damage are the common pathological basis and initiation of cardiovascular and cerebrovascular disease. therefore, reducing blood pressure and delaying or reversing vascular injury is an effective way to treat hypertension and prevent cardiovascular disease. nad+ (nicotinamide adenine dinucleotide) is a coenzyme of many kinds of dehydrogenases in the body, and is an essential molecule in the basic process of life support. the latest research found that with the growth of age, the level of nad+ is decreasing, and increasing the content of nad+ can prolong the life of multiple species including human. nmn (β - nicotinamide mononucleotide) is a natural nad+ precursor in cells. recent clinical trials found that nmn supplementation can effectively improve the level of nad+ in cells, delay aging, improve the metabolic process of cells without adverse reactions. however, the effect of nmn supplementation on reducing blood pressure and protecting vascular endothelial function has not been reported. therefore, this study aims to focus on hypertension, a major chronic disease, and to observe the effects of nmn supplementation on vascular function and blood pressure in patients with hypertension, so as to provide a new treatment strategy for hypertension and associated vascular injury.


Eligibility criteria:
inclusion criteria: * mild essential hypertensive patients (bp ranged from 130/80 to 159/99 mmhg). * ability to undergo study procedures. * willingness/ability to provide informed consent. exclusion criteria: * participants with secondary hypertension. * participants suffering from diabetes mellitus, coronary heart disease, peripheral vascular disease, acute or chronic liver disease, renal insufficiency, malignancies, infectious disease, or using non-steroidal anti-inflammatory drugs, steriods, vasoactive agents. * known allergies to niacin or nicotinamide. * receiving certain concurrent supplements. * women who are currently pregnant or who wish to become pregnant over the course of the study follow-up or who are at suckling period. * unwillingness/inability to provide informed consent.

Keywords: hypertension β-nicotinamide mononucleotide vascular function blood pressure
better lithotripsy and ureteroscopy evaluation of stenting (blues)

Conditions: Renal Stone; Ureteral Stone

Summary: this multi-center trial is being completed to compare patient outcomes related to the imajin silicone stent in comparison to non-silicone polyurethane stents after ureteroscopy. eligible participants will be enrolled and randomly assigned to receive the imajin silicone stent or a non-silicone stent. in addition, the participants will complete questionnaires and have follow-up information collected (approximately 60 days after surgery). the trial hypothesizes that a ureteral stent made of silicone, will have superior outcomes when compared to non-silicone stents.


Eligibility criteria:
inclusion criteria: * stated willingness to comply with all study procedures and availability for the duration of the study * diagnosed with unilateral renal and/or ureteral stones with the largest less than or equal to (≤)2.0 cm in size measured on abdominal x-ray, ultrasound or computerized tomography (ct) scan * renal stone defined as only renal location of stone(s). * ureteral stone defined as ureteral only or ureteral and renal stone(s). * planned unilateral ureteroscopy with stent placement without stent string. * ability to take oral medication. * ability and willingness to complete and adhere to survey questions and responses throughout study duration. exclusion criteria: * known planned secondary or staged procedure * presence of anatomical anomalies (for example (e.g.) solitary, horseshoe, fused crossed ectopia, pelvic kidney) * presence of any prior urinary diversion (e.g. ileal conduit, orthotopic neobladder) * presence of any indwelling ureteral stent prior to ureteroscopy * presence of any indwelling nephrostomy tube prior to ureteroscopy * ancillary ureteroscopy to treat residual fragments after percutaneous renal stone surgery * renal stone located in calyceal diverticulum * no indication for stent placement (e.g. spontaneous passage) * bladder stone location. * pregnancy or lactation * known allergic reactions to polyurethane or silicone

Keywords: ureteral stent ureteroscopy lithotripsy
sleep disruption in new mothers: an intervention trial

Conditions: Pregnancy; Postpartum Period; Sleep Disturbance

Summary: the purpose of this study is to test a behavioral intervention to minimize sleep disruption and fatigue in new mothers after the birth of their first infant. this study also tests whether an acetaminophen intervention at the time of an infant's 2-month immunization series improves infant and maternal sleep.


Eligibility criteria:
inclusion criteria: * pregnant women expecting first singleton birth * able to speak, read, and write in english * willing to participate for 3 consecutive days and nights during 36-39 weeks gestation and at 4, 8, and 12 weeks postpartum * willing to have their infant participate in ankle actigraphy recording of their sleep/wake patterns for 96 hrs at the time of their first immunization exclusion criteria: * history of affective illness prior to pregnancy * current use of medications that may alter sleep * history of a diagnosed sleep disorder such as sleep apnea, nocturnal myoclonus, or narcolepsy * plan to employ live-in help with child care * working the night-shift * multiple pregnancy with twins or more

Keywords: sleep hygiene actigraphy maternal infant postpartum period immunization acetaminophen
gene therapy for patients with leukocyte adherence deficiency (follow-up of phase 1 trial)

Conditions: Leukocyte Adhesion Deficiency Syndrome

Summary: this study will provide long-term monitoring of two patients who received gene therapy for leukocyte adherence deficiency (lad) under the food and drug administration investigational new drug study bb-ind-7949. the ind protocol has been closed. no other patients are eligible for this study. patients previously enrolled in bb-ind-7949 (retrovirus-mediated transfer of the cdna for human cd18 into peripheral blood repopulating cells of patients with leukocyte adherence deficiency) will be followed at least yearly for an indefinite period of time to evaluate their medical status and look for treatment side effects. the follow-up visits at the nih clinical center will involve the following: * interview regarding health status during the past year * blood draw of approximately 15 milliliters for 3 years, then 5 ml annually thereafter for studies related to lad and to make sure no unexpected effects of gene therapy have occurred the blood samples collected at the follow-up visits will be frozen and stored. if a serious medical problem arises, the sample may be checked for replication competent virus. if the gene therapy is suspected to be related to a medical problem, investigation may include a review of the patient's medical records or collection of additional blood or tissues for testing. if the patient should die, the family will be asked permission to perform an autopsy, regardless of the cause of death. tissues taken at autopsy will be tested for any long-term effects from the gene therapy.

patients with leukocyte adhesion deficiency or lad have a deficiency of the leukocyte integrin cd18 on their leukocyte cell surface and suffer from severe bacterial infections. two patients with lad were enrolled in a phase i clinical trial conducted at the university of washington school of medicine in 1999 to determine the safety and potential efficacy of using retroviral vectors containing cd18 to transduce and correct their cd34+ peripheral blood stem cells. this protocol aims to continue the long-term follow-up of these patients at the national cancer institute where dr. hickstein is now a senior investigator. blood samples will be collected at the follow-up visits on the yearly anniversary of the treatment date (either locally or off-site by the patients' personal physicians) for archiving for potential testing for replication competent retrovirus, and for complete blood counts. patients will also undergo a history and physical examination at these visits. results from these tests will be forwarded to the investigators who will report to the nih and fda.

Eligibility criteria:
* two patients treated under fda ind bb-ind-7949.

Keywords: cd18 retrovirus rcr stem cell gene transfer leukocyte adhesion deficiency lad
clinical study of umbilical cord blood mononuclear cell therapy for the treatment of chronic atrophic gastritis

Conditions: Chronic Atrophic Gastritis

Summary: to evaluate the efficacy and safety of umbilical cord blood mononuclear cells in the treatment of chronic atrophic gastritis.


Eligibility criteria:
inclusion criteria: 1. subjects voluntarily participated in the study and signed an informed consent. 2. the age is 18-65 years old, regardless of gender. 3. patients with chronic atrophic gastritis by gastroscopy and pathological examination. 4. patients with a negative c13 breath test or have eradicated helicobacter pylori infection. 5. patients without contraindications to submucosal injection of umbilical cord blood derived mononuclear cells. exclusion criteria: 1. patients with gastric ulcer, erosive gastritis, active upper gastrointestinal bleeding, gastric varices, or other gastric tumors. 2. patients who are taking or have taken proton pump inhibitors, antibiotics, glucocorticoids, nonsteroidal anti-inflammatory drugs and immunosuppressants in the last six months. 3. people who have had gastric surgery or required gastric surgery during the study. 4. patients with severe systemic diseases (diseases of cardiovascular, liver, blood, kidneys, lungs or liver). 5. pregnant or nursing females. 6. patients who are reluctant to accept endoscopy and treatment.
setmelanotide in a single patient with partial lipodystrophy

Conditions: Hypertriglyceridemia; Obesity

Summary: the objective of this single patient study is to assess the safety and efficacy of setmelanotide as a treatment of severe metabolic abnormalities resulting from ld, especially refractory hypertriglyceridemia leading to recurrent bouts of pancreatitis.

this is a single-patient study to assess the safety and efficacy of setmelanotide in a unique patient with partial ld and severe metabolic abnormalities, most notably refractory hypertriglyceridemia leading to recurrent pancreatitis despite ongoing plasmapheresis treatment.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent 2. ability to comply with visits and procedures required by program. 3. has physician-confirmed partial lipodystrophy and the following characteristics: * has atypical lipodystrophy. * has presence of neutralizing antibody to metreleptin * patient has life threatening hypertriglyceridemia and has had \>8 episodes of pancreatitis, requiring weekly plasmapheresis * has type 1 diabetes mellitus with hba1c \> 10%. 4. female, under the age of 18 years exclusion criteria: 1. diagnosis of schizophrenia, bipolar disorder, personality disorder or other diagnostic and statistical manual of mental disorders (dsm-iii) disorders that the investigator believes will interfere significantly with study compliance. neurocognitive disorders affecting ability to consent will not be disqualifying as long as an appropriate guardian able to give consent has been appointed. 2. history or close family history (parents or siblings) of skin cancer or melanoma, or patient history of ocular-cutaneous albinism. 3. significant dermatologic findings relating to melanoma or pre-melanoma skin lesions, determined as part of a screening comprehensive skin evaluation performed by a qualified dermatologist. 4. significant hypersensitivity to study drug. 5. inability to comply with qd injection regimen.
below-elbow or above-elbow cast for extra-articular distal radius fractures

Conditions: Radius Fractures

Summary: the aim of this prospective randomised study was to shed more light on the issue by comparing the capacity of long plaster casts (above-elbow, lc) and short plaster casts (below-elbow, sc) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (2r3a2.2, according to the ao/ota classification). the initial hypothesis was that the short cast would be equally as effective as the long cast in treating this type of fracture. the secondary objective of the study was to determine whether or not there is a direct correlation between radiological parameters and functional outcomes in such patients.

distal radial fractures are common traumatic injuries, but their management remains controversial, hence, we conducted a two-arm, parallel-group, prospective randomised trial to compare the capacity of long casts (above-elbow) and short casts (below-elbow) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (ao/ota classification: 2r3a2.2). eligible patients with ao/ota 2r3a2.2 fractures treated with closed reduction and cast immobilization were randomized to the long cast group or to the short cast group. baseline radiological parameters, radial inclination (ri), radial height (rh), ulnar variance (uv) and palmar tilt (pt) were taken, and compared with clinical (dash, mayo wrist and mayo elbow) and radiological scores taken at 7-10 days, 4 weeks and 12 weeks. furthermore, to evaluate correlations between radiological parameters and functional outcomes, patients were divided into two groups according to whether or not their radiological parameters at follow-ups 2 and 3 were acceptable, i.e. within the range 11-12 mm for rh, 16°-28° for ir, -4-+2 mm for uv, and 0°-22° for pt.

Eligibility criteria:
inclusion criteria: * extra-articular fractures of the distal radius with dorsal displacement (type 2r3a2.2 according to the ao classification). * eligible for conservative treatment with plaster exclusion criteria: * open fractures * extra-articular distal radius fracture with volar displacement * a history of allergy to the cast material * patients scheduled for surgical treatment

Keywords: distal radius fractures above-elbow cast below-elbow cast conservative treatment extra-articular fractures
visual analogue scale - a quality assurance study

Conditions: Surgery

Summary: it has come to our attention that there is not a general consensus of how to apply visual analogue scale (vas) as a tool in measuring pain amongst postoperative patients in denmark. the assumption is that patients will grade the level of pain differently dependent on how vas is presented.

to ensure the data is valid for the study it has been decided to base the research material on four different vas usage, as it is most often used in clinical practise in denmark. which in this case implies vas horizontal, with and without endpoint, and vas vertical, with and without endpoint. every participant will grade their pain on each of the listed vas representations. furthermore, as a guideline, the participant will be asked to grade the pain on a numerical ranking scale (nrs). the ordering of vas lines will be subject to randomization, for each participant

Eligibility criteria:
inclusion criteria: * patient must have undergone surgery within the last five days * the patient must be able and willing to participate in the study * must be at 18 years of age or older * a patient can only participate one time. exclusion criteria: * previously included patients * medically treated patients linguistic difficulties * mentally or physically exhausted
radiation dosimetry, metabolism, pharmacokinetics, safety and tolerability and pet imaging with bay94-9392 in healthy volunteers and patients with cancer or inflammation

Conditions: Diagnostic Imaging; Neoplasms

Summary: visual assessment of diagnostic pet/ct (positron emission tomography/computed tomography) images obtained after a single intravenous injection of bay94-9392 in patients with cancer or inflammation.


Eligibility criteria:
inclusion criteria: in germany healthy volunteers * males/females ≥ 50 and ≤ 65 years patients * males/females ≥ 35 and ≤ 75 years * histologically confirmed diagnosis of non small cell lung cancer or adenocarcinoma of the breast with a positive fdg-pet or * patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-pet, the initial disease is histologically confirmed or * inflammation with a positive fdg-pet in korea patients * males/females ≥ 35 and ≤ 75 years * histologically confirmed diagnosis of non small cell lung cancer, adenocarcinoma of the breast or hepatocellular cancer with a positive fdg-pet or * patient with primary prostate cancer scheduled for prostatectomy and patient with prostate tumor recurrence with a positive choline-pet, the initial disease is histologically confirmed or * inflammation (positive fdg-pet mandatory, could be also done as screening examination) exclusion criteria: * concurrent severe and/or uncontrolled and/or unstable medical disease other than cancer or inflammation (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of bay 94-9392, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study * known sensitivity to the study drug or components of the preparation

Keywords: neoplasm pet/ct diagnosis pet tracer