Kornimate/medical-research-clean huggingface dataset:
study of hiv-1 rgp-160 administered by mucosal routes in healthy volunteers

Conditions: HIV Infections

Summary: it is probable that a mucosal approach is necessary for a prophylactic hiv vaccine protecting against sexually transmitted infection. mucosal immune responses have been almost non-existent in trials of hiv vaccine candidates in which the antigen was delivered systemically. this study will test the safety and immune response of a recombinant hiv-1gp160 by nasal and mucosal routes alone or formulated with dc-chol in healthy volunteers.

it's probable that a mucosal approach is necessary for prophylactic hiv vaccine protecting against sexually transmitted infection. although mucosal immune responses have been almost non-existent in trials of hiv vaccine candidates in which the antigen was delivered systematically. several animal models have also demonstrated the importance or a mucosal iga response for protection against viral infections. mucosal s iga are essential effectors having different mechanisms of action agglutination of pathogens, interaction with cellular receptor, transcytosis of immune complexes, intracellular clearance of virus. gp 160 induces the majority of neutralizing abs activity in patients serum and the immunogenicity of gp 160 can be improved by using and adjuvant such as dc-chol because of its properties to increase the permeation of the nasal epithelium and to facilitate systemic delivery of the vaccine antigen. before beginning mucosal vaccine trial, we previously tested and validated procedures to collect and process secretion fluids on 6 hiv-1 infected women (k. petitprez et al, 4th european mucosal immunology group meeting, lyon france, 8-10 october 2004).

Eligibility criteria:
inclusion criteria: * women chosen in a uniform selection process specifically designed by the anrs (french national agency for research on aids and viral hepatitis) * for women of child-bearing age : use of effective contraception * normal clinical status * ability to accept collection of secretion fluids; * ability to sign informed consent exclusion criteria: * pregnancy

Keywords: hiv vaccines hiv seronegativity
efficacy and safety of anx005 in subjects with guillain-barré syndrome

Conditions: Guillain-Barre Syndrome

Summary: this study is intended to evaluate the efficacy and safety of anx005 administered by intravenous (iv) infusion to participants recently diagnosed with guillain-barré syndrome (gbs). the total duration of study participation is approximately 6 months.


Eligibility criteria:
inclusion criteria: * diagnosis of gbs according to the national institute of neurological disorders and stroke diagnostic criteria for guillain-barré syndrome. * onset of gbs-related weakness ≤10 days prior to start of infusion. * gbs-ds score of 3,4, or 5 at screening and at day 1 prior to infusion. exclusion criteria: * clinically significant findings on the screening electrocardiogram (ecg), laboratory test results, or physical examination that are not specific to gbs that may interfere with the conduct of the study, the interpretation of the data, or increase the participant's risk. * body weight \ 150 kg at screening. * unresponsive (inexcitable) nerve conduction study results in all nerves tested during screening. * previous or intended treatment with either plasma exchange or intravenous immunoglobulin for gbs. * diagnosis of a variant of gbs, including miller fisher syndrome, bickerstaff's encephalitis, and overlap syndromes. * history of prior episode of gbs. * gbs-related weakness that improved since symptom onset, including an improvement between screening and day 1 (baseline).
the study of the implantation window from endometrial biopsy with gene expression methods

Conditions: Infertility, Female; IVF

Summary: the objective of the study is to gain a better understanding of the gene expression changes in the endometrial biopsy especially whether the endometrium has reached a receptive status, i.e. the implantation window, or not.

the endometrium goes through huge gene expression changes during a cycle, the cells are transformed, the mucous membrane thickens, then loosens, and finally sheds. in this process, the expression of the genes also goes through significant changes, which can be determined from a small tissue sample. endometrium biopsy samples can be used for endometrium phasing. a question of the study is the feasibility of using for endometrium phasing beside endometrium tissue biopsy also samples generated by endometrium lavage. the advantage of this latter method is that it is minimally invasive, it does not cause haemorrhage and has minimal side effects. in some selected cases endometrial lavage will be performed on the same day with endometrial tissue sampling together with the drawing of a peripheral blood sample. a list of potential biomarkers was proposed from the meta-analysis of published gene expression datasets. from the endometrium derived samples, rna will be isolated and gene expression biomarkers will be measured. expression profiles will be compared to published reference samples.

Eligibility criteria:
inclusion criteria: * infertile women participating in the diagnostic evaluation of infertility. exclusion criteria: * patients who are legally incapable or partially capable * pregnancy should be excluded before sampling * bleeding problems * the active phase of severe psychiatric disorders

Keywords: gene expression biomarkers implantation window embryo transfer endometrium biopsy lavage liquid biopsy
the relation between abdominal obesity, type 2 diabetes mellitus and knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: background:knee osteoarthritis is more common in patients with type-2 diabetes mellitus, however it is not known whether this effect is caused by diabetes itself or concominant abdominal obesity. objectives:the aim of this study is to determine whether type-2 diabetes itself, independent of abdominal obesity, is a risk factor for femoral cartilage, knee osteoarthritis and poor quality of life. design:a cross-sectional design. settings:training and research hospital in turkey. patients and methods:female patients was enrolled in this study and divided into two groups: according to presence or absence of diabetes. later, both the patients with and without abdominal obesity was divided into two groups according the presence of diabetes. main outcome measures:clinical parameters were visual analog-scale, gait speed and short form-36. knee radiographs were evaluated according to kellgren lawrance-scale. and ultrasonography parameters were the measurements of distal femoral cartilage thickness. sample size:126


Eligibility criteria:
inclusion criteria: * being female * aged between 40 and 70. exclusion criteria: * patients with any concomitant chronic disease * rheumatoid arthritis * cardiac diseases (except type 2 diabetes mellitus and hypertension) * knee surgery * trauma * bone mass or cancer * inflammatory arthritis * impaired cognitive status * immobilized patients * type 1 diabetes mellitus

Keywords: knee osteoarthritis type 2 diabetes
use of electromyography with bio-feedback for the treatment of craniomandibular disorders

Conditions: Craniomandibular Dysfunction; Orofacial Pain

Summary: the treatment of craniomandibular disorders is a challenging task. many different treatments are yet available with occlusal splints being one of the most commonly used. a relative new diagnostic and treatment alternative is the grindcare device. this enables the electromyographic (emg) assessment of the activity of the temporal muscle and the contigent electrical stimulation of this muscle as bio-feedback whenever the emg activity exceeds a certain limit. this stimulation results to a sudden break of the muscle activity. aim of this study is to compare the therapeutic efficacy of the grindcare device in pain reduction at female non-chronic cmd patients to that of a michigan-type splint. our null-hypothesis was that there is no difference between the device and the splint in the reduction of pain intensity.


Eligibility criteria:
inclusion criteria: * signed informed consent form * age between 18 and 70 years * non-chronic painful cmd with/without mandibular movement restriction * female exclusion criteria: * pregnancy or breastfeeding * chronic pain status higher than 2 * known allergic reaction against the gel pads * electronic implants (pacemaker, defibrilator, insulin pump) * facial pain of dental or neuropathic etiology * traumatic injuries of the face / operations * dental treatment need * problems with swallowing reflex
a study to compare administration schedules of g-csf (filgrastim) for primary prophylaxis of febrile neutropenia

Conditions: Early Stage Breast Cancer

Summary: in patients with early-stage breast cancer, chemotherapy has substantially improved survival rates. improvements in outcomes, however, are compromised by the considerable toxicities associated with chemotherapy, the most notable being neutropenia. neutropenia is the presence of abnormally few white blood cells, leading to increase susceptibility to infection and can require hospitalization and need for intravenous antibiotics and is sometimes fatal. febrile neutropenia (fn) can also be associated with treatment delays and dose reductions, potentially compromising treatment efficacy. patients can receive medication to reduce the risk of fn such as neupogen (filgrastim) as a daily injection for 5, 7 or 10 days. since there is genuine uncertainty among healthcare professionals as to which administration schedule of neupogen is the best for patients, the investigators are performing a randomized study for which patients will receive either 5, 7 or 10 days of neupogen. neupogen can cost approximately $200/injection, so if a physician prescribes 10 days for 8 cycles of treatment, this can cost $16,000 compared to a 5 day treatment which would cost half this. in addition to cost savings, many patients are not able to give themselves injections on a daily basis and require nursing resources which are utilized at high cost. this study will use an oral consent model to compare 5, 7 and 10 days of neupogen to evaluate rates of febrile neutropenia and hospitalization.


Eligibility criteria:
inclusion criteria: * histologically confirmed primary breast cancer * planned to start docetaxel component of fec-d or ac-d, or first cycle of; dose-dense ac-t, tc, fec-d or tac chemotherapy * ≥19 years of age * able to provide verbal consent exclusion criteria: * contraindication to filgrastim
(acth) for the treatment of sarcoid uveitis

Conditions: Sarcoid Uveitis

Summary: sarcoidosis is a multisystem granulomatous disease that can affect nearly any organ in the body. while most commonly affecting the lungs, vision threatening eye involvement occurs in approximately 25% of patients with sarcoid. eye involvement may lead to a chronic, sight-threatening uveitis which may result in cataract, glaucoma, and macular edema. the treatment of sarcoid uveitis involves the use of topical and systemic corticosteroids or potent immunosuppressive agents (medications that suppress the body's immune system) both of which can cause severe long-term side effects. the adverse effects of steroids may be avoided by treatment with the use as h.p. acthar® gel. the effectiveness of h.p. acthar® gel in the treatment of sarcoid uveitis and patient quality of live have not been previously examined. these issues, will be explored in this research.

the investigator seeks to determine the efficacy of h.p. acthar® gel (40 units twice weekly injection) of on disease activity and severity in patients with sarcoid uveitis. the retrospective study will evaluate a series of quantitative outcome measures: the degree of aqueous and vitreous inflammatory cells as graded by the criteria established by the standardization of uveitis nomenclature (sun) criteria at intervals of 0 weeks, 3 weeks, 6 weeks, 12 weeks and 24 weeks. the degree of aqueous flare as graded by the criteria established by the standardization of uveitis nomenclature (sun) criteria at intervals of 0 weeks, 4 weeks,12 weeks and 24 weeks. best corrected visual acuity at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks. central macular thickness at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by optical coherence tomography (oct). intraocular pressure at intervals of 0 weeks, 4 weeks, 12 weeks and 24 weeks as measured by applanation tonometry quality of life assessment using national eye institute visual function questionnaire (vfq-25) the investigator expects to retrospectively review the charts of 10 sarcoid associated uveitis patients treated with acthar® gel over a period of 1 year.

Eligibility criteria:
inclusion criteria: presence of sarcoid uveitis as determined by * clinical exam * fluorescence angiography * optical coherence tomography exclusion criteria: * presence of long acting intraocular depots * women of childbearing age not using contraceptives
to study the clinical characteristics and treatment outcome of covid-19 patients admitted in hospitals of max healthcare (scope study)

Conditions: COVID

Summary: this is an observational study for corona virus disease by the max healthcare.corona virus 2019 disease (covid-19) is a respiratory tract infectious disease caused by a newly emergent corona virus. this virus is linked to the same family of viruses as severe acute respiratory syndrome (sars) and some types of common cold.

in view of increasing cases in india and the possibility of the exponential rise of cases, study has been designed to observe the patient profile and outcomes for hospitalized positive covid-19 patients that may help to understand the effectiveness of different treatment strategies. this is a retrospective and prospective, observational study based on collection of data related to covid-19 admitted patients treated in the hospitals of max healthcare as per the standard treatment protocol and policy for covid 19 at max healthcare. covid19 patients shall be approached at the time of admission for participation in this study. if the patient consents, the participating investigator or designated study personnel will collect the baseline demographic details of the patient, along with medical history; current disease status; current and previous treatment details; and the results of all the laboratory tests performed, as per the standard clinical practices. daily follow up will be done on a structured case record form (crf) till the discharge or death.

Eligibility criteria:
inclusion criteria: 1. patients of either sex aged ≥18 years 2. patients who are covid-19 positive 3. all patients with positive corona virus infection admitted in the hospitals of max healthcare will be included in the study. exclusion criteria: -
fertility and cardiovascular risk in men with metabolic syndrome

Conditions: Metabolic Syndrome

Summary: men diagnosed with metabolic syndrome (mets) including obesity, hypertension, dyslipidemia and infertility will be assessed for cardiovascular and diabetes risk. the eligible patient will be randomised to one-year life-style intervention program including nutritional, behavioural and exercise counselling or standard care by the general physician. the aim of the program is to reduce cardiovascular and diabetes risks and hypogonadism as well.


Eligibility criteria:
inclusion criteria: * age\>18 years, wish for fatherhood in stable partnership, metabolic syndrome according to guidelines (minimum 3 out of 5 criteria), ready to participate in 1-yr lifestyle program exclusion criteria: * not conforming to mets diagnosis criteria, sterilisation, promiscuous behaviour, contraindications against established medical or surgical treatment of obesity, participation in another weight-loss program
cilostazol augmentation study in dementia

Conditions: Alzheimer's Dementia

Summary: the purpose of this study is to examine the effects of cilostazol augmentation in mild to moderate alzheimer disease patients with subcortical white matter hyperintensities (wmhi) treated by donepezil. dementia is the most disabling disease in the old age. the prevalence of dementia is 5-10% of the elders. acheis (donepezil, galantamine, rivastigmine) are used to treat mild to moderate dementia, but these drugs only relate to symptomatic improvement and the response rates are less than 30%. cilostazol is a cyclic adenosine monophosphate phosphodiesterase 3 inhibitor (pde3i) and used as antiplatelet agent in subcortical vascular disease (wmhi). and it upregulates phosphorylation of cyclic adenosine monophosphate-pathway response element binding protein (creb) which plays a crucial role in memory enhancement and synaptic plasticity related to neurodegeneration prevention. the investigators will try cilostazol augmentation in dementia patients with wmhi receiving donepezil to see the addictive effects of cilostazol using cognitive tasks and pet imaging.


Eligibility criteria:
inclusion criteria: * men/women over sixty years old * patients with slight and moderate dementia (mmse score is over 10 under 26.) * patients with probable alzheimer's disease according to the standard of nincds-adrda * patients accompanied with wmhi on brain mri (fazeka's scale 1\~3) exclusion criteria: * those who do not agree to the test in a written form * patients who accompany other diseases except cerebral atrophy or change of subcortical white matter due to alzheimer's disease on brain mri * patients who should not use cilostazol (① patients with bleeding tendency ② patients with congestive heart failure ③ patients who have a medical history of hypersensitivity to this medicine or constituent of this medicine ④ those who use anticoagulant and clot buster) * patients who suffer from nerve diseases or mental diseases which have influence on cognitive function except alzheimer's disease (for example, schizophrenia, severe depression, mental retardation and etc.) * patients who are suspected to have a personal history of drug addiction or alcoholism within recent 10 years * patients who have severe problems in eye sight or hearing so that it is impossible to conduct the test smoothly * patients who the researchers think are inappropriate for taking part in the test

Keywords: alzheimer's dementia cilostazol
s&b heat stress pilot protocols

Conditions: Thermal Discomfort

Summary: the purpose of this study is to develop a heat stress program for the construction industry and evaluate its feasibility and appeal.


Eligibility criteria:
inclusion criteria: * employed at s\&b * work more than 20 hours a week exclusion criteria: * severe chronic disease (e.g. severe pulmonary or cardiovascular disease * history of severe heat stroke * use of a pacemaker * any medical issue which would render the participant unable to wear a chest monitor and cooling vest.
effect of cold therapy implementation on multi-modal postoperative pain management

Conditions: Pain, Postoperative

Summary: this is a pilot randomized controlled trial examining post-operative pain scores and outcomes after laparoscopic hysterectomy in patients prescribed cold therapy as an adjunct to routine post-operative multi-modal analgesia, compared to those patients prescribed routine multi-modal analgesia without cold therapy. all patients scheduled for total laparoscopic hysterectomy (without robotic-assistance) will be screened for eligibility in the study. if eligible, patients will be invited to participate in the study and standardized informed consent process will ensue. after surgery is completed participants will be randomized to either the control group or the study group. the study group will be prescribed the use of cold therapy to their abdominal incisions through reusable cold gel packs. the cold therapy is to be applied to participants' incisions for the first three postoperative days, in addition to routine post-operative analgesia regimen. investigators will then collect information on pain scores, narcotic use, quality of life and surgical recovery scores. this study aims to examine if there is a difference in post-operative pain scores with the application of cold therapy to laparoscopic abdominal incisions following laparoscopic hysterectomy, when compared to no cold therapy. secondarily, investigators will examine post-operative quality of life scores, postoperative surgical recovery scores, as well as narcotic use among the two groups. investigators also aim to ascertain additional information regarding total quantity of narcotics used post-operatively to aid in prescribing patterns.


Eligibility criteria:
inclusion criteria: 1. patients can understand and voluntarily sign an informed consent form 2. female gender ages 18-65 3. scheduled for laparoscopic hysterectomy for benign indications, total or subtotal, without or without oophorectomy (standard of care involves bilateral salpingectomy) exclusion criteria: 1. conversion to laparotomy 2. diagnosis of chronic pelvic pain 3. no access to freezer at home to keep reusable cold packs cold between uses 4. contraindications to exposure to cold therapy (history of cold allergy, cold intolerance, raynaud's disease, cold urticaria, cryoglobulinemia, or pyoderma gangrenosum) 5. medical contraindication to nsaid use
outcomes of liver transplantation in low weight children after reducing the lateral segment of a living donor, adapting the shape and size of the graft to the needs of the recipient

Conditions: Liver Transplantation; Low-weight Children; Hyper-reduced Liver Grafts

Summary: the shortage of organs has always been a problem in pediatric liver transplants due to the lack of donors with an adequate size. different techniques of hepatic reduction have been described that allow to use larger organs in the pediatric population. however, in these techniques the maximum reduction achieved by segments 2 and 3 is excessive for low-weight children. since 1997 the liver transplantation group at hospital italiano de buenos aires has developed and practiced a technique called hepatic hyper-reduction, which consists in reducing the lateral segment of a living donor, adapting the shape and size of the graft to the needs of the recipient. the investigators have performed approximately 50 pediatric liver transplants with live donors in low weight children in whom the hyper-reduction technique has been applied. the aim of the present study is to describe postoperative morbidity and mortality and analyze overall and graft survival.


Eligibility criteria:
inclusion criteria: * \< or = 17 years old. * having undergone live donor liver transplantation. * having received hyper-reduced liver grafts * at the liver transplantation unit of the hospital italiano de buenos aires * between june 1997 and april 2018 exclusion criteria: * \> 17 years old. * cadaveric liver transplant * whole liver grafts.

Keywords: liver transplantation hyper-reduction graft survival overall survival