Kornimate/medical-research-clean huggingface dataset:
impact of a neonatal-bereavement-support dvd on grief

Conditions: Grief; Depressive Symptoms

Summary: experts agree that neonatal death has long-term impact on parents. many parents experience sadness, pain, anger, bouts of crying, and a depressed mood after the death of a child. there are no prospective studies that evaluate the effectiveness of bereavement management and follow-up on the grief process following the death of a newborn. the purpose of this study is to evaluate the impact of a neonatal intensive care unit (nicu) bereavement support program and the use of a newly designed family-centered bereavement dvd. this educational dvd includes personal interviews with parents, grandparents and siblings who have experienced the lost of a baby in the nicu.

the care given to a family before and following a neonatal loss can set the stage for a family's entire grieving process. for many parents, the support they receive from health care providers after the loss of a baby may have crucial effects on the family's ability to appropriately respond. it is essential for nurses, practitioners, physicians, and chaplains to provide compassionate care that meets or exceeds parents' expectations. however, supporting families following the death of an infant is particularly challenging. there is limited bereavement intervention guidance in the literature that may benefit grieving parents. follow-up care is a crucial part of bereavement management of families whose babies have died. the bereavement committee at st. louis children's hospital (slch) is a multi-disciplinary team, which includes representation from neonatal nurses and nurse practitioners, neonatologists, social workers, chaplains, patient-care associates, and former bereaved parents. their role is to assist families both at the time of an infant's death and in securing their baby's personal belongings after the family leaves the hospital. in addition to receiving bereavement materials, which is considered standard-practice of care in the nicu at slch following the death of an infant, half of the parents enrolled in the study will be prospectively randomized to receive the educational bereavement dvd entitled 'grieving in the nicu- mending broken hearts when a baby dies too soon'.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * any parent who has experienced the death of a baby in the nicu at slch or has had a baby treated in the nicu who has died at home with hospice care exclusion criteria: * babies who are at home longer than one month with hospice care will be excluded * those who are not english speaking or who are illiterate

Keywords: depression spirituality neonatal death bereavement randomized controlled trial
ultrasound evaluation of fluid tolerance for acute kidney injury

Conditions: Acute Kidney Injury

Summary: fluid expansion with isotonic crystalloids is a first-line intervention in the treatment of patients with acute kidney injury (aki). while it is generally accepted that the timely correction of kidney hypoperfusion will minimize the extent of injury as well as potentially facilitate recovery, there are potential harms involved in indiscriminate administration of intravenous fluids. although anticipating fluid tolerance is part of the clinical evaluation of a patient for whom intravenous fluid therapy is considered, it has been suggested that using point-of-care ultrasound (pocus) may enable the early identification of patients with a high-risk of congestive complications and guide clinical decisions with greater precision\[1\]. however, it has not been shown that providing this information in the context of aki result in a change in management or a prevention of complications. this single-center pilot randomized controlled trial aim to determine the feasibility of comparing a management including a pocus evaluation of fluid tolerance to usual care in non-critically ill patients with aki. in the intervention group, a pocus evaluation will be performed and interpreted by experienced staff producing a report that will be presented to the attending care team. this assessment will be repeated 48-72 hours later. the primary aim of the study will be to establish the feasibility of this intervention. secondary objectives will include determining the difference between the intervention arm and the control arm in relationship with fluid administration, diuretic use, evolution of kidney function, and intensification of care.


Eligibility criteria:
inclusion criteria: 1. adults ≥ 18 year-old 2. admitted to the hospital 3. acute kidney injury defined by the kdigo criteria\[48\] 4. fluid expansion is considered by attending nephrologist or already ongoing exclusion criteria: 1. admitted to the intensive care unit 2. known stage 5 chronic kidney disease according to the kdigo classification receiving renal replacement therapy or not. 3. renal replacement therapy for aki has been initiated or is planned within 24 hours

Keywords: point-of-care ultrasound vexus lung ultrasound fluid therapy acute kidney injury
adherence, efficacy and tolerance of once-a-day nevirapine-based regimen in hiv-1 infected patients

Conditions: HIV Infections

Summary: taking antiretrovirals once-a-day is considered the simpler way to improve adherence. however, it is not know if this assertion apply to patients taking their medication twice-a-day who change to once-a-day. we hypothesized that once-daily dosing improves adherence.


Eligibility criteria:
inclusion criteria: * hiv-1 infected adults receiving antiretroviral therapy including nevirapine twice-a-day for at least 6 months * plasma hiv rna\<400 cp/ml during the previous 4 months on 2 occasions * accept adherence electronic monitoring * written informed consent signed exclusion criteria: * asparate aminotransferase (ast) or alanine aminotransferase (alt) \>2.5n if hepatitis virus b or c were negative * ast or alt\>1.25n if hepatitis virus b or c were positive

Keywords: once-a-day adherence nevirapine patient noncompliance administration and dosage treatment experienced
assessing the effect of periodontal debridement, tongue cleaning and mouth rinsing for the treatment of oral malodour

Conditions: Halitosis

Summary: this study evaluates the short and long term effect of dental cleaning and mouthrinsing for the treatment of bad breath

the majority of bad breath producing bacteria can be found in pockets around the gums and the top of the tongue. it is generally agreed that one of the most effective means of controlling the production of bad breath gases from these bacteria is their mechanical removal. tongue cleaning has shown consistent results in the reduction of bad breath, while dental cleaning has shown positive, but less conclusive results. the addition of a mouth rinse to mechanical measures has shown medium-term effectiveness, however there is currently no information available that describes the long-term impact of mechanical and chemical measures for the treatment of bad breath and the appropriate interval for follow-up and on-going management to prevent difficult cases.

Eligibility criteria:
inclusion criteria: organoleptic score of 2 or more, and volatile sulfur compound score of greater than 1.5ng/10ml of hydrogen sulfide and 0.5ng/10ml of methyl mercaptan - exclusion criteria: * moderate to severe periodontal disease, systemic illness or dental disease associated with halitosis, antibiotic use in the past month, need for antibiotic prophylaxis for dental procedures and current smokers

Keywords: halitosis, periodontal debridement, chemotherapeutics
efficacy of pharmacotherapy to enhance weight loss following sleeve gastrectomy

Conditions: Obesity

Summary: the study will investigate the effects of metformin and topiramate prescribed at 4 weeks post-surgery on overall weight loss at 6 months post-surgery. the investigators will study patients who, based on current diagnoses and medication regimens, could be expected to benefit the most by taking a medication to facilitate additional post-surgery weight loss. patients scheduled to undergo laparoscopic sleeve gastrectomy (lsg) at hartford hospital's bariatric and metabolic surgery program will be screened, consented and enrolled in the study. prior to surgery patients will be randomized to either pharmacotherapy or no pharmacotherapy following lsg. for those randomized to receive pharmacotherapy, medications will be initiated at 4 weeks, as this is the estimated time post-lsg at which patients advance from a liquid diet to soft foods allowing medications to be better tolerated. once randomly assigned to the medication group, patients will receive metformin or topiramate based upon physician judgment and medical history. dosages will not be adjusted during the course of the study. the primary outcome will be % total body weight loss (%twl) at 6 months following surgery, as the majority of the weight loss after lsg occurs during the first 6 months. data collected through up to 12 months will be analyzed. the %twl for both arms of the study will also be assessed at 8 weeks, 16 weeks, and 9 months and one-year post-lsg. resolution of comorbidities will be noted.


Eligibility criteria:
inclusion criteria: * patients scheduled for sleeve gastrectomy as primary bariatric treatment exclusion criteria: * qualified for roux en y gastric bypass * on fda approved weight loss medications prior to bariatric surgery * required to continue topiramate, zonisamide, and buproprion for other chronic diseases after bariatric surgery * on metformin, dulaglutide, exenatide, exenatide extended release, liraglutide, empaglifozin, canaglifozin, dapaglifozin, buproprion, zonisamide, and topiramate, prior to surgery. * have had lap band or other prior bariatric surgery * glomular filtration rate \< 45 * over 70 years old * not fluent in english
microbiota and allergy

Conditions: Allergy

Summary: food allergy derives from a dysregulation of oral tolerance mechanisms. studies suggest a crucial role for gut microbiota in oral tolerance development. an altered composition of gut microbiota results in an unbalanced local and systemic immune response to food allergens. there are qualitative and quantitative differences in gut microbiota composition in children with food allergy. preliminary results of matfa study demonstrated gut microbiota in allergic children.these findings support the pivotal role of the gut microbiota in the pathogenesis of allergic diseases and may open new strategies in the development of innovative preventive and therapeutic approaches.


Eligibility criteria:
inclusion criteria: * children with sure diagnosis of food allergy, * children with sure diagnosis of respiratory allergy exclusion criteria: * age at enrollment \ 84 months; * eosinophilic disorders of the gastrointestinal tract; * chronic systemic diseases; * congenital cardiac defects; * acute or chronic infections; * autoimmune diseases; * immunodeficiencies; * chronic inflammatory bowel diseases; * celiac disease; * cystic fibrosis or other forms of primary pancreatic insufficiency; * genetic and metabolic diseases; * food intolerances; * malignancy; * chronic pulmonary diseases; * malformations of the respiratory tract or of the gastrointestinal tract; * pre-, pro- or sinbiotic use in the previous 3 months; * antibiotics or gastric acidity inhibitors use in the previous 3 months.
prevention of drug use in adolescence: intervening in parenting styles

Conditions: Substance-Related Disorders

Summary: to investigate whether brief motivational intervention is associated with the change of parenting style in parents of teenagers seeking to prevent drug use among their children.


Eligibility criteria:
inclusion criteria: * parents of adolescents aged 10-15 years who call for the service call 132 looking for a program to prevent drug use and accept to participate in the study after reading the statement of consent exclusion criteria: * be excluded individuals that are experiencing difficulty in answering the questions and those who refuse to participate in the study elucidated by ic

Keywords: primary prevention substance-related disorders family
a phase ii trial of sti571 in the treatment of metastatic gastric cancer

Conditions: Recurrent Gastric Cancer; Stage IV Gastric Cancer

Summary: imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. this phase ii trial is studying how well imatinib mesylate works in treating patients with refractory metastatic and/or unresectable stomach or gastroesophageal junction cancer.

primary objectives: i. to determine the response rate, time to tumor progression, and overall survival in patients with metastatic gastric cancer treated with sti571 who have failed one chemotherapy regimen for metastatic disease. ii. to assess the toxicities of sti571 in these patients. iii. to obtain preliminary data on molecular correlates to determine clinical efficacy and toxicity. outline: this is a multicenter study. patients are stratified according to risk (good risk \[chemonaïve\] vs poor risk \[1 prior chemotherapy regimen\]). patients receive oral imatinib mesylate twice daily on days 1-28. courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. patients are followed for 30 days. projected accrual: a total of 21-41 patients will be accrued for this study within 1-1.5 years.

Eligibility criteria:
inclusion criteria: * patients with metastatic and/or unresectable carcinoma of the stomach, who have measurable disease * life expectancy \> 3 months * karnofsky performance status \> 60% * absence of an active infection * granulocyte count of \> 1,500/mm\^3 * hemoglobin (hgb) \>= 9 mg/dl * serum bilirubin =\< 1.5 mg/dl, regardless of liver involvement secondary to tumor * platelets \> 100,000/mm\^3 * serum glutamic oxaloacetic transaminase (sgot) and serum glutamate pyruvate transaminase (sgpt) \< 2.5 x the institutional upper limit of normal * calculated creatinine clearance of \> 60 ml/min * patients must have signed written informed consent * female patients of child-bearing potential must have a negative blood or urine pregnancy test within two weeks prior to initial study treatment * patients who have had prior chemotherapy or radiation therapy must have recovered from any toxicities prior to study entry * patients must have radiographic imaging to document measurable disease within 28 days prior to initial study therapy exclusion criteria: * diagnosis of resectable carcinoma of the stomach * major surgery within four weeks of study entry * brain metastasis or known seizure disorder * fertile men and women not using an acceptable method of contraception * pregnant or lactating patients are excluded since sti571 may be harmful to the developing fetus and child * patients known to be hiv positive and receiving haart are excluded because of possibly pharmacological interactions * active peptic ulceration or active gastrointestinal bleeding or any active bleeding disorders * use of therapeutic doses of coumadin (warfarin) as anticoagulation * medical, social, or psychological factors which would prevent the patient from completing the treatment protocol * patients with serious intercurrent illness which would preclude tolerance and completion of the protocol treatment
a comparative assessment of transfemoral prosthetic sockets

Conditions: Amputation; Amputation; Traumatic, Leg, Lower

Summary: the objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making.

the objective of the proposed work is to enhance understanding of the potential benefits of adjustable sockets and inform clinical decision making. the investigators will explore a range of outcomes that have been found to be important for prostheses users and specifically assess the claims made by device manufacturers. thirty adults with a transfemoral amputation will participate in four test sessions; one with their clinically prescribed, laminated socket, and three with different adjustable sockets. this data will be used to test the following aims: 1) does socket design impact socket comfort and prosthetic satisfaction? 2) does socket design impact of prosthetic socket on patient mobility and confidence, 3) how does prosthetic socket design influences prosthetic use in the home?, and 4) are individual characteristics associated with benefits of specific socket designs?

Eligibility criteria:
inclusion criteria: * unilateral lower-limb amputation * six months of independent ambulation * own and regularly wear a prosthesis with socket * minimum functional level of k2 on the medicare functional classification level (mfcl): corresponding to "the ability or potential for ambulation with the ability to traverse low-level environmental barriers such as curbs, stairs, or uneven surfaces. typical of the limited community ambulator" exclusion criteria: * pathology or injury of the intact limb * medication that affects their ability to walk * neurologic or cardiovascular disease * significant vision problems * suffer from an impaired mental capacity that negatively impacts verbal communication with the clinicians and research team, or requires a legally authorized representative to facilitate communication

Keywords: socket transfemoral
study to evaluate additional risk minimisation measures (armms) for reblozyl among healthcare professionals (hcps)

Conditions: Myelodysplastic Syndromes; Beta-thalassemia

Summary: this is a non-interventional post-authorization safety study (pass) employing a cross sectional design to evaluate the effectiveness of the additional risk minimization measures (armms) for reblozyl. a survey will be used to measure the knowledge and comprehension of the reblozyl armms among european economic area (eea) based healthcare professionals (hcps). the pass will be conducted among hcps in a representative sample of eea countries where reblozyl is commercially available, potentially including austria, germany, italy, norway, sweden, the netherlands, poland, and spain. additional eea countries may be included, as needed, based on commercial availability and reimbursement status.


Eligibility criteria:
inclusion criteria: * healthcare professionals (hcps) experienced in treatment of haematological diseases who may intend to prescribe reblozyl in the participating european countries and were on the target group for dissemination of the additional risk minimization measures (armms). * the hcp provides permission to share their responses in aggregate with european medicines agency (ema) or national competent authorities (ncas), if requested. exclusion criteria: * hcps who previously participated in the cognitive pre-testing of the survey questionnaires to be used for the study. * hcps who have been direct employees of the marketing authorization holder (mah), the ema, or the study vendor within the past 5 years.

Keywords: reblozyl myelodysplastic syndromes healthcare professionals post-authorization safety study additional educational measures beta-thalassemia luspatercept
prospective, multicenter da vinci® sp™ surgical system tors study

Conditions: Oropharyngeal Cancer

Summary: a prospective, multicenter investigation of the da vinci® sp™ surgical system in transoral robotic surgery (tors) procedures for malignant oropharyngeal tumors.

a prospective, multicenter investigation to evaluate the safety and clinical performance of the da vinci sp surgical system, instruments, and accessories in tors procedures for malignant oropharyngeal tumors classified as t1 and t2.

Eligibility criteria:
inclusion criteria: * 18 years or older * t1 or t2 malignant oropharyngeal tumor * tumor amenable to transoral resection * no previous treatment for the index tumor * willing and able to provide written informed consent * willing and able to comply with the study protocol requirements exclusion criteria: * t3 or t4 stage tumor * previous radiation treatment to the head and neck, with or without chemotherapy * evidence of other primary cancers or distant metastasis or subject with synchronous primary tumor excluding skin cancers * pre-operative expectation of needing microvascular soft-tissue reconstruction * tumor that invades and/or abuts the internal and/or external carotid artery * retropharyngeal carotid artery coincident with a tonsillar cancer or posterior pharyngeal wall cancer * evidence of mandibular invasion of tumor * eastern cooperative oncology group performance status score greater than or equal to 2 * on a medication that interferes with clotting that cannot be stopped prior to surgery * contraindication for general anesthesia or surgery * mentally handicapped or has psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent * pregnant or suspected to be pregnant
long-term outcomes of patients with primary amyloidosis after stem cell transplantation

Conditions: Amyloidosis

Summary: this study examines the value of stem cell transplantation in managing light chain amyloidisis.

1. how does age at diagnosis affect prognosis in primary amyloidosis? 2. how do lab values at diagnosis such as creatinine, ast/alt, total serum protein, serum gamma globulin/immunoglobulin levels affect prognosis in primary amyloidosis? 3. how does degree of organ involvement/number of organs involved affect prognosis in primary amyloidosis? 4. how does initial treatment affect prognosis in primary amyloidosis? 4. how do the specifics the stem cell transplant protocol affect prognosis in primary amyloidosis?

Eligibility criteria:
inclusion criteria: * eligible for stem cell transplantation less than age 75 exclusion criteria: * creatinine \> 3.0 * bnp \> 10000

Keywords: amyloidosis
sperm quality in consecutive sperm samples after 4-7 days and 2 hours of sexual abstinence

Conditions: Semen Quality

Summary: the main purpose of the study is to assess to which degree a series of sperm parameters known to be associated with fertilization and implantation potential in artificial reproductive technology (art) differ in consecutive sperm samples produced after 2-7 days and 2 hours of sexual abstinence in males from couples referring for art treatment.


Eligibility criteria:
inclusion criteria: * male age between 18 and 50 * able to understand and read danish exclusion criteria: * complete azospermia * significant psychological illness * significant cardiovascular disease

Keywords: semen quality sexual abstinence sperm motility dna fragmentation
preoperative evaluation of airway

Conditions: Obesity; Difficult Intubation

Summary: evaluation of airway markers of patients who have undergone obesity surgery.

the investigators evaluated the airway parameters recorded preoperatively for patients with bmi\> 30 who were undervent bariatric surgery between 2015-2018 in terms of difficult airway.

Eligibility criteria:
inclusion criteria: 1. bmi\>30kg/m2 2. 18\<age \<65 3. elective surgery planned 4. asa ii-iii exclusion criteria: 1. bmi\<30kg/m2 2. 18\>age \>65 3. asa iv

Keywords: difficult airway, obese patient,