Kornimate/medical-research-clean huggingface dataset:
bone mineral density substudy - an ancillary study to mtn-003

Conditions: HIV Infections

Summary: the mtn-003 hiv prevention study include the use of microbicides, substances that kill microbes, and tenofovir disoproxil fumarate (tdf) and emtricitabine/tenofovir disoproxil fumarate (ftc/tdf) - oral, fda-approved, anti-hiv drugs. the purpose of this study is to determine if taking daily tdf and ftc/tdf as a part of the study mtn-003 has an effect on bone mineral density (bmd).

the effect of tenofovir on bone mineral density (bmd) has not yet been studied and is of potential concern. the purpose of this study is to determine the changes in bmd among individuals receiving tdf and ftc/tdf compared with a placebo. this substudy will enroll individuals currently participating in mtn-003. the expected duration of participation for each participant is approximately 48 months. study treatment will be provided by mtn-003. study treatment will not be provided by this substudy. study visits will occur every 6 months after enrollment. a nutrition assessment, physical activity history, and urine and blood collection will occur at all visits.

Eligibility criteria:
inclusion criteria: * enrolled in mtn-003 * randomized to oral study product in mtn-003 within 14 days prior to study entry exclusion criteria: * medical condition known to affect bone or taking any medication known to affect bone. more information on this criterion can be found in the protocol. * permanently discontinued from oral study product in mtn-003 prior to study entry * any condition that, in the opinion of the investigator, would interfere with the study * pregnant

Keywords: microbicide hiv seronegativity bone mineral density
evaluation of inflammatory markers in ph negative myeloproliferative neoplasms: impact on outcome and response to therapy. multicenter retro-prospective observational study. the infla-me (inflammation in myeloproliferative disease) study.

Conditions: Myeloproliferative Disease; Inflammatory Markers

Summary: this study aims to observe inflammatory biomarkers and their trend over the history of the disease in patients suffering from mpn ph negative; it also wants to identify any correlations between the aforementioned biomarkers and disease outcomes, considering first of all the occurrence of thrombo-haemorrhagic events and the evolution in the accelerated / blast phase of the disease, shedding light on new tools that can potentially guarantee a prompt and better risk stratification


Eligibility criteria:
inclusion criteria: * age ≥ 18 years at the time of diagnosis of mpn ph negative * diagnosis of pv, et, pmf or post pv and post et mf, according to current who or iwg-mrt criteria (diagnosis since 2000) * obtaining informed consent exclusion criteria: * life expectancy of less than 6 months * accelerated phase myelofibrosis or mpn with signs of leukemic evolution
gnrh agonist at embryo transfer: ivf outcomes

Conditions: Infertility; Infertility, Female; Infertility, Male

Summary: in art (assisted reproductive technology) cycles, embryos are transferred to a woman's uterus after in-vitro fertilization (ivf) in a laboratory. usually, hormones (progesterone) are given to the patient after transferring the embryo, as a supplement, in order to mimic the natural hormones that would normally be secreted in an unassisted pregnancy. this study will identify whether additional gonadotropin-releasing hormone (gnrh-agonist) administration, a natural hormone secreted from the hypothalamus, will improve the clinical pregnancy and live birth rates when using ivf.

this is a randomized, double-blinded, placebo-controlled study. on the day of embryo transfer (5-6 days after a fresh egg retrieval and on the 6th day of progesterone administration in a frozen embryo transfer cycle), patients will receive either a single injection of 20 units (1mg) of lupron or an identical placebo injection. patients undergoing day 3 embryo transfers will not be eligible and will not be randomized. randomization will be in 22 blocks of 20 patients. based on the power analysis with a power of 0.8 and alpha-error of 0.05, the investigators will need to enroll 352 patients, so the investigators will recruit 440 to account for attrition. randomization scheme will be computed via a computerized program accessible at randomization.com or via spss. there will be one randomization: both fresh and frozen embryo cycles will be randomized in the same group. sequential cards with randomization allocation will be placed in doubly sealed, opaque envelopes, with a single sheet confirming eligibility status. confirmation of the presence of the signed informed consent will be in the first envelope. the second envelope will be opened after there is confirmation that the patient is eligible and consented. this envelope will have a card stating the group the patient has been assigned to, with blank spaces designated to record patient information. this card will be completed by the study staff and saved for reference purposes. the card will state the group that the patient was randomized to, the date of embryo transfer, the patient's medical record number, name, and cycle type. there will also be a log book to record the information and medication lot numbers. injections will be prepared at the time of randomization by the research coordinator and will be administered by the clinical rn, who will not know its contents. the clinical staff assessing and planning care of the patient (attending physicians and nurses) will not know the contents of the syringe (either lupron 20 iu or the same amount of normal saline).

Eligibility criteria:
inclusion criteria: * women undergoing in-vitro fertilization who are receiving an embryo transfer of a day 5 blastocyst exclusion criteria: * those who have a contraindication to receiving the medication

Keywords: in-vitro fertilization
daoib for the treatment of cognitive function and behavioral and psychological symptoms of dementia

Conditions: Behavioral and Psychological Symptoms in Alzheimer's Disease; Behavioral and Psychological Symptoms in Vascular Dementia

Summary: the population of dementia is increasing rapidly. cognitive impairment as well as behavioral and psychological symptoms of dementia (bpsd) add heavy burdens to caregiver. nmda activation is critical for learning and memory. individuals with alzheimer's disease (ad) have fewer nmda receptors in the frontal cortex and hippocampus than controls. this study is a randomized, double-blind, placebo-controlled drug trial. all patients will be allocated randomly to two groups: (1) nmda enhancer: daoib (starting dosage: 250-500 mg/day), (2) placebo, for 6 weeks. the investigators hypothesize that daoib may yield better efficacy than placebo for cognitive function and clinical symptoms in patients with bpsd.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of probable alzheimer's disease or probable vascular dementia * for patients with vascular dementia, the post-stroke period must be more than 3 months * mini-mental state scores between 5-26 * clinical dementia rating score equal to or greater than 1 * behavioral pathology in alzheimer's disease rating scale score equal to or greater than 2 exclusion criteria: * current substance abuse or history of substance dependence in the past 6 months * other major psychiatric diagnoses, such as schizophrenia, major depressive disorder, bipolar disorder and mental retardation etc. * serious medical or neurological illness other than alzheimer's disease/vascular dementia and other secondary dementia
changes in incretins response and glycemic control after gastric bypass surgery in type 2 diabetic patients versus healthy

Conditions: Type 2 Diabetes; Obesity

Summary: the purpose of this study is to determine the early changes in gut hormonal, and other metabolites with known relations to the glycemic homeostasis. the study mainly focus on these responses to food in the diabetic patient, compared to the non-diabetic, after gastric bypass surgery. also aiming for recording changes in the earliest postoperative phase.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * obesity bmi \>35 exclusion criteria: * prior bariatric surgery

Keywords: type 2 diabetes bariatric surgery incretines glp-1 gip gastric bypass foregut hindgut
pirfenidone combined with methylprednisolone versus methylprednisolone in the treatment of cip

Conditions: Pneumonitis; Malignant Tumor

Summary: checkpoint inhibitor-related pneumonitis (cip）is a common fatal immune-related adverse event of pd-1/pd-l1 inhibitors. some cip patients have poor effect on hormone therapy, and the remission time of cip varies greatly. antifibrotic drugs may be effective in patients with cip.

pirfenidone can inhibit the occurrence and development of pulmonary fibrosis, reduce pulmonary exudation by inhibiting vegf and promote pulmonary recovery. in our study, subjects with checkpoint inhibitor-related pneumonitis receive pirfenidone plus methylprednisolone or methylprednisolone.

Eligibility criteria:
inclusion criteria: 1. male or female who is 18 to 75 years old. 2. malignant tumors proved by pathology. 3. the subject has received at least one course of immune checkpoint inhibitor treatment. 4. the subject developed grade 3-4 cip. 5. take proper contraceptive measures. 6. appropriate organ system function. 7. subjects voluntarily participate in this study and sign the informed consent. exclusion criteria: 1. previous treatment with pirfenidone. 2. clinically significant hemoptysis occurred within 3 months before enrollment (hemoptysis greater than 50ml per day); or significant clinical bleeding symptoms or clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood + + or above, or macrovasculitis. 3. arteriovenous thrombosis events occurred within 12 months before enrollment, such as cerebrovascular accident, deep venous thrombosis and pulmonary embolism. 4. abdominal surgery was performed 4 weeks before enrollment, or there was a history of hollow organ perforation. 5. use nintedanib, cyclophosphamide or cyclosporin within 56 days before enrollment. 6. suffering from active pulmonary tuberculosis. 7. patients with mental illness and poor compliance. 8. sperm / egg donors within 6 months. 9. lactating women. 10. persons allergic to pirfenidone. 11. in the investigator's judgment, there are other factors that may have led to the termination of the study.

Keywords: pirfenidone methylprednisolone
nursing intervention in supporting family caregivers of patients undergoing stem cell transplant

Conditions: Anxiety Disorder; Depression; Fatigue

Summary: this randomized clinical trial studies nursing intervention in supporting family caregivers (fcs) of patients undergoing stem cell transplant. a nursing intervention may help prepare fcs support the recovery of the patients

primary objectives: i. test the effects of an advanced practice nursing (apn) intervention for family caregivers (fcs) of hematopoietic cell transplant (hct) patients in the experimental group on fc quality of life, psychological distress, caregiver burden, caregiver skills preparedness as compared to fcs in the control group. ii. describe self-care behaviors for fcs of hct patients and compare them between the experimental and control groups. iii. describe resource use by fcs comparing the experimental and control groups. iv. identify subgroups of fcs who benefit most from the family caregiver intervention (fci) in relation to sociodemographic characteristics, caregiver health status, and patient characteristics. secondary objectives: i. describe family caregivers' satisfaction with the fci. outline: fcs are randomized to 1 of 2 groups. group i: fcs receive 4 sessions of an apn fci beginning during the admission for transplant and continuing for up to 100 days after transplant. group ii: fcs receive standard supportive care. after completion of study, fcs are followed up at 3, 6, and 12 months.

Eligibility criteria:
inclusion criteria: * the primary family caregiver as identified by a hematologic cancer patient who is scheduled for a single allogeneic bone marrow or stem cell transplant; the definition of a family caregiver for the purposes of this proposal refers to either a family member or friend that is identified by the patient as being the primary caregiver * living within a 50 mile radius of city of hope exclusion criteria: * caregivers who are unable to read english or spanish consent forms * caregivers who live more than 50 miles from city of hope
support staff-client interactions with augmentative and alternative communication

Conditions: Intellectual Disability

Summary: this exploratory and observational study focuses on adults with an intellectual disability (id) and their support workers. two groups of clients are observed: clients using key word signing, and clients using aided augmentative and alternative communication (aac). approximately half of adults with id is estimated to experience communication difficulties. aac supports them in their daily communication aiming at optimal participation in society. current communication models, such as participation model (beukelman \& mirenda, 2005) and international classification of functioning, disability and health (who, 2001), regard both client-related and environmental factors as important elements of communication. a substantial part of the environmental factors is made up of the communication partners' characteristics. in daycare and residential services for adults with id the support worker is an important communication partner .

this study aims to: 1. with regard to teaching key word signing (kws), a specific form of aac, to support workers: analyse the relation between training method, support workers' attitude, and short and long term sign knowledge. 2. with regard to the use of manual signs in everyday communication between support workers and adults with id: * identity the support workers' characteristics that may influence the quality/quantity of the communication between adults with id who use manual signs and their support worker. * analyse the nature of this influence as well as any possible interaction effects with the clients' characteristics. 3. assess whether an existing instrument, designed for measuring interactions between parents and children with cerebral palsy using aac, may be used with adults client and support workers.

Eligibility criteria:
inclusion criteria: * uses aac with client * client has congenital intellectual disability * supports client for at least 6 months exclusion criteria: * client has dementia symptoms * client has severe, non-corrected visual impairment * client has diagnosed autism

Keywords: aac support worker direct care staff intellectual disability learning disability communication adults
functional imaging of cerebellar mutism syndrome

Conditions: Brain Mass

Summary: the purpose of this study is to better understand why some children with cancer have difficulty speaking after brain surgery. difficulty speaking may be due to known complications to the language centers in the brain. these language centers may be located in slightly different places in different people. this study will study which areas may be damaged.


Eligibility criteria:
inclusion criteria: * subject and/or guardian is able to provide written informed consent prior to study registration * age ≥3 years and ≤21 years * newly diagnosed, untreated mass in posterior fossa, either benign or malignant * is being evaluated for surgical resection of the mass * able to perform clinical language testing in english exclusion criteria: * claustrophobia * any contraindication to mri (e.g., pacemaker, aneurysm clip, tissue expander). * pregnant or nursing female * does not speak english as a primary language (as determined by the p.i. or treating physician after discussion with a potential subject and his/her family) * preexisting language or developmental disorder that would limit ability to cooperate with testing (as determined by the p.i. or treating physician after interviewing potential subject and his/her family; for example, a child may be excluded if he/she has confirmed or suspected autism spectrum disorder, dysarthria, dyslexia, lisp, hypotonia, or other age inappropriate speech development)

Keywords: mass in posterior fossa benign malignant surgical resection mri fmri dti 12-121
comparison between two methods of pancreatic transection in distal pancreatectomy

Conditions: Pancreatic Fistula; Distal Pancreatectomy

Summary: several systematic reviews have investigated the management of the pancreatic stump in order to reduce the postoperative pancreatic fistula (popf) rate after distal pancreatectomy (dp). the appropriate closure technique of the pancreatic stump is still debated. there is no published experience about the comparison of the endo gia reinforced reload with tri-staple technology (ts) versus harmonic focus (us) after distal pancreatectomy (dp) regarding the reduction of popf. the investigators want to compare the incidence of clinically-relevant popf (cr-popf) after dp, depending upon the transection technique (ts versus us). this is a randomized controlled, multicenter, patient-blinded, superiority trial. this protocol was designed according to the spirit guidelines. two groups of 76 patients (152 in total) with an indication for elective minimally invasive or open dp for a lesion of the body-tail of the pancreas. the two techniques analyzed are endo gia reinforced reload with tri-staple technology (ts) and harmonic focus (us) as control. the primary endpoint is to evaluate the incidence of cr-popf rate after dp. secondary endpoints are intraoperative outcomes (blood loss, operative time and conversion of the minimally invasive procedure), postoperative outcomes (complications rate; hospitalization parameters to 90 days; mortality) and treatment costs.


Eligibility criteria:
inclusion criteria: * scheduled for elective dp via a minimally invasive (laparoscopic or robotic) or open technique, either preserving the spleen or with splenectomy, depending on the diagnosis/nature of the tumor * asa score \< 4 * ability of the subject to understand character and individual consequences of the clinical trial * written informed consent exclusion criteria: * pancreas thickness \>17mm measured at the intraoperative ultrasound at the pancreatic transection level * metastatic disease * kidney or adrenal gland resection * arterial resection (celiac axis, superior mesenteric artery, hepatic artery) * intestinal resections and anastomoses or stoma * acute necrotizing and chronic pancreatitis * immune suppressed patients * pregnant women * patients with contraindications for distal pancreatectomy * impaired mental state or language problems
pibd-setquality: the inception cohort and safety registry

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis

Summary: the purpose of this study is to analyse effectiveness and safety signals of current treatment strategies in routine practice for patients with pediatric-onset inflammatory bowel disease (pibd) and to correlate this to their individual risk factors.

in this prospective observational study children with newly diagnosed inflammatory bowel disease (ibd) will be included in the inception cohort. the primary aim of the inception cohort is to analyse the effectiveness and safety signals of current treatment strategies and to correlate them to individual risk factors. in order to capture information on rare and severe complications in pibd as well, the safety registry was designed to estimate incidence and prevalence rates of these complications and get more insight in disease and treatment characteristics of these patients.

Eligibility criteria:
inclusion criteria inception cohort: newly diagnosed patient, \<18 years of age, with a likely diagnosis of ibd or a confirmed diagnosis of ibd can be included in the study. in order to be eligible to continue in the study the subject must meet all of the following criteria: * diagnosis is based on history, physical examination, laboratory, endoscopic, radiological and histological features according to the revised porto criteria (1) * diagnosis has been made or is confirmed within 2 months of inclusion * data on all diagnostic procedures are available for inclusion in the database * informed consent of patient (if indicated) and parents has been obtained * concerning the patients of whom biological specimens will be included: patients have not started ibd treatment yet inclusion criteria safety registry: any child with ibd \<19 years old with complications as detailed in the agreed safety monitoring list (or future updates of the list of conditions) can be reported. for the initial reporting of incident cases no patient identifiable details will be required. exclusion criteria inception cohort: * inability to read and understand the patient and family information sheets (for example insufficient knowledge of national language, where no health advocate or family member is available to translate and ensure full understanding of the study) * informed consent of patient or parents has not been obtained when required * patients on similar treatments as for ibd but for other conditions, or known with conditions directly affecting the ibd (e.g. immunodeficiency or major gastrointestinal resections) exclusion criteria safety registry: none.
stretching versus traction in patients with cervical radiculopathy.

Conditions: Cervical Radiculopathy

Summary: the purpose of the study is to compare the effects of traction decompression and neck muscle stretching on the magnitude of flexor carpi radialis h-reflex(hr), neck disability index (ndi), and visual analogue scale (vas) pain scores in patients with cervical radiculopathy.

cervical traction has long been used to relieve compression of nerve roots caused by intervertebral discs. yet, there is lack of knowledge that compares the effect of traction decompression with neck muscles stretching in patients with cervical radiculopathy

Eligibility criteria:
inclusion criteria: * patients should have c5-c6 and c6-c7 paramedian disc protrusion manifested by unilateral symptoms in c6-c7 roots dermatome and myotomes of the upper extremities. * they were diagnosed as cervical disc protrusion (c5- c7) for at least three months. * all patients should have a second grade of disc bulge (2-3mm) which was detected from t2 axial view of mri. exclusion criteria: * patients will be excluded from the study if they have upper cervical spine disc pathology, cord compression and upper motor neuron symptoms, curvature abnormalities of the neck including reversed curve (kyphotic) and deformities, cervical rib syndrome, double crush syndrome, diabetic neuropathy, text neck , short neck (churchill neck), marked facet joint, neuro-central joint arthropathic pathology, osteoporosis.

Keywords: stretching, traction decompression