Kornimate/medical-research-clean huggingface dataset:
dietary intervention trial targeting metabolic syndrome after kidney transplantation

Conditions: Kidney Transplant; Complications

Summary: kidney transplant recipients (ktr) have a considerably lower life expectancy as compared with the general population, primarily due to a high prevalence of cardiovascular diseases. ktr often develop an unfavourable cardio-metabolic risk profile characterized by weight gain, metabolic syndrome and post-transplantation diabetes mellitus (ptdm). in general, nutrition plays a key role in both the prevention and treatment of these cardio-metabolic derangements. however, in ktr most rct's with a dietary intervention, failed to show significant improvement in cardio-metabolic health. this at least questions the efficacy of the diets of these intervention, which relied on general or diabetes guidelines, after kidney transplantation. ktr not only face a high cardio-metabolic risk, but also have a high risk for malnutrition and muscle mass depletion. more knowledge is required to determine the optimal diet and macronutrient composition for improvement of the cardio-metabolic risk factors in the context of the high malnutrition risk. in this regard, observational studies point towards the needs for a higher protein intake for better patient outcomes. therefore, in this study, the investigators will examine if a high-protein, carbohydrate-reduced diet is more effective than a diet in line with the dutch dietary guidelines for improvement of cardio-metabolic risk factors and for improvement of the body composition in ktr.


Eligibility criteria:
inclusion criteria: * age 18 years or older. * given informed consent. * at least 6 months after kidney transplantation. * stable renal function with an estimated glomerular filtration rate (egfr) \> 30 ml/min. * raised systolic blood pressure (≥130 mmhg) and at least two more features of metabolic syndrome: central obesity (waist circumference ≥102 for men and ≥88cm for women), elevated triglycerides (≥ 1.7 mmol/l), reduced hdl-c (\< 1.0 mmol/l for men and \< 1.3 mmol/l for women) or on drug treatment for reduced hdl, elevated plasma glucose (≥ 5.6 mmol/l) or on drug treatment for elevated glucose9. * approval by nephrologist for participation in the study. exclusion criteria: * active medical illness, including rejection of the graft. * psychopathology or serious cognitive impairment. * necessity to follow specific dietary measures for health purposes that conflict with the study diets. * use of insulin or sulfonylurea (su)-derivates. * language barrier. * pregnancy or lactating. * serum potassium \> 5.0 mmol/l that requires dietary measures. * moderate or severe malnutrition (patient-generated subjective global assessment (pg-sga) stage b or c). in this case, patient will be referred to a renal dietician. * participation in other intervention trials.

Keywords: kidney transplantation metabolic syndrome high-protein diet dietary intervention
cetylated fatty acid for reducing pain after tka

Conditions: Postoperative Pain; Postoperative Inflammation

Summary: to compare efficacy of cetylated fatty acid with placebo for reducing postoperative pain after unilateral tka. the hypothesis is topical cetylated fatty acid can mitigate postoperative pain after tka.


Eligibility criteria:
inclusion criteria: * age 50-80 years * osteoarthritic knee patients underwent unilateral primary tka * participants understand and consent to the protocol of the trial exclusion criteria: * inflammatory knee arthritis * previous knee surgery or trauma * previous knee infection * skin problem around the knee such as eczema, psoriasis, wound infection * allergy to studied drug

Keywords: cetylated fatty acid tka postoperative pain inflammation
promoting human papillomavirus (hpv) vaccination through african american beauty salons

Conditions: Human Papilloma Virus

Summary: the investigators propose a non-randomized pilot study to assess the feasibility and effectiveness of using urban beauty salons as settings for culturally-competent health education about hpv vaccination. the educational messages will engage individual women, their peer group, their family members and community influencers in a way that is authentic and share-able. involving women in give-and-take discussions with people they trust and respect-their hairdressers-will be essential to increasing the number of them who consider the hpv vaccine for themselves and for those they care about. the investigators believe that it is only after women who are opinion leaders among their peers begin positively supporting hpv prevention that it will gain wider acceptance. the investigators plan to recruit eight (8) predominantly african american beauty salons in philadelphia and train multiple stylists in each salon to act as in-salon educators and facilitators for client recruitment to sexual health education sessions. these education sessions will be run by trained health educators (also african american females) and take place during "down times" in each of the salons, on a rotating basis. * the investigators hypothesize the ability to successfully recruit eight (8) beauty salons for participation * the investigators hypothesize the ability to successfully train multiple stylists per site to talk to their clients about hpv and its impact on women of color * the investigators hypothesize that knowledge and awareness of hpv, as well as intentions to vaccinate will significantly improve among women who attend a salon-based health education session


Eligibility criteria:
inclusion criteria: * mother of an 9-18 year old female * female who is 18-26 years old exclusion criteria: * not a mother of an 9-18 year old female * not a female who is 18-26 years old

Keywords: hpv vaccination beauty salons health education sexual health
clinical efficacy of intravenous iclaprim versus vancomycin in the treatment of hospital-acquired, ventilator-associated, or health-care-associated pneumonia

Conditions: Hospital-Acquired Pneumonia; Ventilator-Associated Pneumonia; Health-Care-Associated Pneumonia

Summary: the purpose of this study is to compare the clinical cure rates of two dosing regimens of iclaprim with vancomycin (every 12 hours \[q12h\]) in the treatment of patients with hospital-acquired pneumonia (hap), ventilator-associated pneumonia (vap), or health-care-associated pneumonia (hcap) suspected or confirmed to be due to gram-positive pathogens.


Eligibility criteria:
inclusion criteria: * suspected or confirmed acute bacterial pneumonia due to gram-positive pathogens in one of the following subgroups: * hospital-acquired pneumonia (hap), i.e., pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission; or * ventilator-associated pneumonia (vap), i.e., pneumonia that arises more than 48 hours after endotracheal intubation; or * health-care-associated pneumonia (hcap), i.e., pneumonia diagnosed within 48 hours of hospital admission, in a patient who fulfills at least one of the following criteria: 1. hospitalization for at least two days within 90 days of the current infection, 2. residence in a nursing home or long-term care facility, 3. recipient of intravenous antibiotic therapy, chemotherapy, or wound care within 30 days of the current infection exclusion criteria: * acute physiology and chronic health enquiry (apache) ii score \< 8 or ≥ 25. * pneumonia not requiring empiric or targeted treatment effective against gram-positive pathogens. * pulmonary infection due to gram-positive organisms known to be resistant to either study medication prior to study entry.

Keywords: pneumonia nosocomial pneumonia
endoscopic submucosal dissection (esd)

Conditions: Esophageal Lesion; Barrett Esophagus; Gastrointestinal Lesions

Summary: this registry is to evaluate the procedural and clinical outcomes in patients undergoing endoscopic submucosal dissection. all patients will receive standard of medical care and no experimental interventions will be performed.

the technique of endoscopic mucosal resection (emr) is currently widely used in the us to remove precancerous or cancerous lesions confined to the mucosa of the gi tract. emr carries lower morbidity and mortality compare to surgery, at the expense of a higher rate of piecemeal removal, incomplete resection and cancer recurrence. endoscopic submucosal dissection (esd) is a newer technique developed in japan that involves en-bloc resection of the entire lesion irrespective of size, allowing for a detailed analysis of the resected margins and depth of invasion and producing a lower local recurrence. due to the lack of dedicated esd devices the procedure has not been disseminated in western countries. recently the food and drug administration (fda) approved a number of devices for esd. the vast majority of studies evaluating the clinical outcomes from esd are originating in japan where the technique is mostly applied to patients with early gastric cancer (japan has the highest incidence of gastric cancer in the word). in the us lesions that are currently treated with emr are mostly located in the esophagus (barrett esophagus) and colon (large adenomatous polyps and intramucosal cancer). these esophageal and colonic lesions can be treated with esd with expected higher rate of en-block resection and lower recurrence rate compare to emr. with the differences in patient population and disease location one can anticipate some differences in outcomes between esd performed in asian and us patients. therefore, the investigator wants to prospectively record the experience with esd done as part of routine medical care in united states (us) population. this will be a prospective data recording study. all patients will receive standard medical care and no experimental interventions will be performed.

Eligibility criteria:
inclusion criteria: * age 18 years or older * scheduled to undergo esd exclusion criteria: * any contraindication to performing endoscopy * participation in another research protocol that could interfere or influence the outcomes measures of the present study.
study to evaluate kos-1584 in patients with advanced or metastatic stage iiib/iv non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to determine the objective response rate of kos-1584, as a single agent in patients with stage iiib/iv nsclc whose disease has progressed following initial chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven nsclc, stage iiib or stage iv. * eligible patients must have received only one prior chemotherapy regime for stage iiib/iv nsclc. * good performance status. exclusion criteria: * prior treatment with an epothilone. * known central nervous system (cns) metastases. * any chemotherapy, radiation therapy or immunotherapy or any investigational agent (therapeutic or diagnostic) within 3 weeks prior to first study drug administration.

Keywords: patients with advanced or metastatic stage iiib/iv non-small cell lung cancer
amniotic membrane and anterior stromal puncture to the treatment of symptomatic bullous keratopathy

Conditions: Bullous Keratopathy

Summary: the purpose of this study is to determine whether amniotic membrane transplantation is as effective as anterior stromal puncture in the relief of symptomatic bullous keratopathy.

patients with symptomatic bullous keratopathy were randomized in 2 groups and submitted to amniotic membrane transplantation or anterior stromal puncture. the follow up was made with 1, 3, 6 and 12 months. evaluation included complete ophthalmologic exam, esthesiometry, pachymetry, impression cytology and evaluation of pain.

Eligibility criteria:
inclusion criteria: * bullous keratopathy exclusion criteria: * age under 18 years old * asymptomatic bullous keratopathy * corneal infection * ocular hypertension

Keywords: pain bullous keratopathy amniotic membrane anterior stromal puncture
an observational study of pegasys (peginterferon alfa-2a) in chinese patients with hbeag negative chronic hepatitis b

Conditions: Hepatitis B, Chronic

Summary: this multicenter, prospective, observational study will evaluate the use in clinical practice and the efficacy and safety of pegasys (peginterferon alfa-2a) in chinese participants with hbeag negative chronic hepatitis b. participants receiving pegasys according to the local label will be followed for the duration of their treatment and for one year after cessation of treatment.


Eligibility criteria:
inclusion criteria: * adult participants, \>/= 18 years of age * treatment with pegasys according to label and standard clinical practice * hbeag negative serologically proven chronic hepatitis b with or without cirrhosis * serum alanine aminotransferase (alt) \> upper limit of normal (uln) but \</= 10 x uln * hepatitis b virus (hbv) dna \>/= 2000 iu/ml exclusion criteria: * contraindications to pegasys as detailed in the label * co-infection with hepatitis a, hepatitis c or hiv * pregnant or lactating women * participants should not receive concomitant therapy with telbivudine
the effect of honey on xerostomia and oral mucositis

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to determine whether the use of pure honey will help in the treatment of radiation induced xerostomia and oral mucositis (symptom management)

radiation-induced mucositis is a normal acute side effect of radiotherapy treatment. exposure of ionising radiation to oral, pharyngeal and laryngeal mucosa gives rise to radiation epithelitis towards the second and third weeks of conventional fractionated radiotherapy. likewise, salivary flow may decrease by approximately 50% during the first week of radiotherapy and upwards of 80% by the seventh week of treatment. acute radiation-induced xerostomia is associated with inflammatory reaction. the study will include an intervention and a control group, one receiving honey prior and after the radiotherapy and the other group not receiving honey at all.

Eligibility criteria:
inclusion criteria: * patients who receive radiotherapy (rt) to the oral cavity will be included in the study. * patients with a confirmed histologic diagnosis of head and neck cancer referred to non-palliative radiotherapy will enter into this trial. * aged over 18 * receiving radiotherapy for at least four weeks exclusion criteria: * allergic to honey * confirmed and medically treated diabetes mellitus

Keywords: head and neck cancer radiotherapy induced xerostomia radiotherapy induced oral mucositis rct symptom management
the association of pelvic organ prolapse severity and urinary symptoms/sexual function

Conditions: Pelvic Organ Prolapse

Summary: women with pelvic organ prolapse often accompany with urinary symptoms or sexual dysfunction, and analyzing the association will be helpful to identify the indication of proper management. therefore, the aim of this study is to identify the above associations.


Eligibility criteria:
inclusion criteria: * all cases with with pelvic organ prolapse exclusion criteria: * nil

Keywords: pelvic organ prolapse urinary symptoms sexual function
caregiver training to prevent konzo disease in children in democratic republic of congo (drc)

Conditions: Malnutrition; Manihot Species Poisoning

Summary: the proposed research adapted the caregiver training and child neurodevelopmental assessment capacity that the pi previously built in uganda beginning in 2008, to a community-based intervention model for the prevention of konzo in the democratic republic of congo.

early childhood (1 through 4 yrs) is a period of dramatic developmental change that can be seriously compromised by exposure to toxic cyanogenic cassava (konzo disease), with potentially great impact throughout central and western sub-sahara africa in regions dependent on this food staple. in the face of ongoing economic instability and nutritional, medical and educational deprivation affecting konzo at-risk communities in the democratic republic of congo, no programs exist for sustaining a favorable developmental milieu for these children. by establishing the viability of caregiver training interventions to enhance functionality among caregivers and improve caregiving quality while preventing konzo, this research l can benefit tens of millions of children at-risk neurodevelopmentally; not only from poorly processed cyanogenic cassava, but also from a myriad of other non-infectious and infectious diseases.

Eligibility criteria:
inclusion criteria: * mother with at least one child aged between 1 and 4 years * mother is the primary caregiver of child * mother is 18 years of age or older exclusion criteria: * history of brain injury (infectious, traumatic, birth) in child * konzo disease in any family member of household * epilepsy in child * any neurodisability in child * caregiver is unable to participate in the year-long training
prevention of osteoporotic fracture 2 pilot study

Conditions: Fragility Fracture

Summary: with the aging of the world population, osteoporosis and fragility fractures have become global public health concerns. it has been estimated the population of people ≥60 years of age will increase from 229 million (16.2%) in 2017 to 479 million (35.1%) by 2050 in china. because age is an important predictor of osteoporosis and fragility fracture, the incidence of fragility fracture has increased dramatically in china over the past decades. timely treatment of osteoporosis is an effective way to decrease additional fracture risk among patients with fragility fractures, but anti-osteoporosis treatment rate is relatively low in china. effective fracture prevention intervention is urgently needed in china. as a potential way to achieve effective risk communication, shared decision-making allows patients to be active participants in the management of osteoporosis. the investigators designed a multifaceted intervention, which was named as "precise education + shared decision-making" program for the secondary prevention of fragility fractures based on behavioral theories, and assessed the effectiveness for fracture prevention using a pilot cluster randomized controlled trial among several hospitals in china. the aim of this pilot study is to test the acceptability and feasibility as well as preliminary efficacy of this program in patients with fragility fractures.


Eligibility criteria:
inclusion criteria: 1. local residents (live in the city where the hospital is located for half a year or more); 2. hospitalized patients with fractures aged 50 years and above; 3. first fracture, without history of fracture; 4. never diagnosed as "osteoporosis" before admission; 5. no fracture history, and never receive any bone mineral density test, and never take anti-osteoporosis medication in the 4 years before admission; 6. hospitalized patients with the following fractures: hip fracture, thoracic spine fracture, and lumbar spine fracture; 7. new fragility fracture: fracture that occurs after minor trauma or daily activities, such as a fracture caused by a fall from standing height or less; fracture happened within 6 weeks; 8. not living in a nursing or rehabilitation institution before fracture; 9. possess reading ability, and can read and understand informed consent forms or medical materials independently. exclusion criteria: 1. patients with pathological fractures caused by tumor or infection; 2. patients with cognitive dysfunction or mental disorder; 3. aids patients; 4. patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up; 5. hearing or visual impairment, and unable to communicate or read materials; 6. patients who have participate in other studies; 7. other conditions that the investigator considered inappropriate to enroll.

Keywords: osteoporosis fragility fracture shared decision-making education
clinical trial of da-5212 in patients with functional dyspepsia

Conditions: Functional Dyspepsia

Summary: this study is to evaluate efficacy and safety of da-5212 in patients with functional dyspepsia


Eligibility criteria:
inclusion criteria: * men or women ≥ 19 years of age * patients who diagnosed with functional dyspepsia * patients with no organic cause for digestive symptoms found by upper gastrointestinal endoscopy at screening visit exclusion criteria: * patients with organic disease or medical history that may cause dyspepsia within 6 months before screening visit * patients who have a history of drugs or alcohol abuse and dependence within 6 months before screening visit * patients with hypersensitivity to investigational drugs and similar drugs * pregnant or breastfeeding women
the registry of very early estrogen and anovulation

Conditions: Hypothalamic Amenorrhea, Functional; Hypothalamic Amenorrhea; Functional Hypogonadotropic Hypogonadism

Summary: the purpose of this study is to to build a registry of women with early estrogen loss due to functional hypothalamic amenorrhea (fha) to understand the prevalence, racial and ethnic diversity of this condition.


Eligibility criteria:
inclusion criteria: * 3 or more months of consecutive amenorrhea with a diagnosis of functional hypothalamic amenorrhea or screening hormones consistent with functional hypothalamic amenorrhea including but not limited to: * estradiol: \< 50pg/ml * lh: \< 10 iu/ml * fsh: \< 10 iu * testosterone: 2 - 45 ng/dl * free testosterone: 0.1 - 6.4 pg/ml * ft4: 0.93 - 1.70 ng/dl * prolactin: \< 20 ng/ml * amh: \> 1 ng/ml * urine or serum human chorionic gonadotropin: negative * lh:fsh ratio \<1 * no signs of male-like hair growth on the upper lip, chin, chest, abdomen, buttocks, or back * does not have a diagnosis for secondary amenorrhea, including prolactinoma, pcos, premature ovarian insufficiency, pituitary surgery, infection, or infarction * premenopausal status determined by wise criteria * able to give informed consent * able to read english exclusion criteria: * parturition/lactating in the last 6-12 months * lack of consent

Keywords: anovulation estrogen loss hypoestrogenemia