Kornimate/medical-research-clean huggingface dataset:
study of chimerivax™ dengue tetravalent vaccine in adult subjects

Conditions: Dengue; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Virus

Summary: to evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the chimerivax™ dengue tetravalent vaccine primary objectives: * to describe the safety of one injection of chimerivax™ dengue tetravalent vaccine. * to describe the immune response against dengue before and after one injection of chimerivax™ dengue tetravalent vaccine

this study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40 years and previously immunised with a dengue or yf vaccine.

Eligibility criteria:
inclusion criteria : * aged 18 to 40 years on the day of inclusion. * informed consent form signed. * for a woman, inability to bear a child or negative serum pregnancy test. * completed the one-year follow-up of study div12. * able to attend all scheduled visits and to comply with all trial procedures. * for a woman of child-bearing potential: use of an effective method of contraception or abstinence for at least four weeks prior to vaccination and at least four weeks after vaccination. exclusion criteria : * history of thymic pathology (thymoma), thymectomy, or myasthenia gravis. * breast-feeding. * systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. * previous flavivirus vaccination, e.g. japanese encephalitis or yellow fever. * current abuse of alcohol or drug addiction that may interfere with the subject's ability to comply with trial procedures. * planned participation in another clinical trial during the present trial period. * history of flavivirus infection (confirmed either clinically, serologically or microbiologically). * congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding six months, or long-term systemic corticosteroids therapy. * chronic illness at a stage that could interfere with trial conduct or completion. * blood or blood-derived products received in the past three months. * vaccination planned in the four weeks following the trial vaccination. * flavivirus vaccination planned during the present trial period. * planned travel during the present trial period to areas with high dengue endemicity. * subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised without his/her consent. * participation in another clinical trial in the four weeks preceding the trial vaccination. * any vaccination in the four weeks preceding the trial vaccination. * human immunodeficiency virus (hiv), hepatitis b (ag hbs) or hepatitis c (hc) seropositivity in blood sample taken at screening. * laboratory abnormalities considered clinically significant upon the investigator's judgement in blood sample taken at screening. * positive flavivirus serological test in blood sample taken at screening (for controls only).

Keywords: dengue dengue fever dengue hemorrhagic fever dengue virus
laser spectroscopy of breast tissue through a needle device

Conditions: Breast Cancer

Summary: rationale: collecting and storing samples of breast tissue from patients who have undergone biopsy or surgery to test in the laboratory may help the study of cancer in the future. purpose: this laboratory study is looking at samples of breast tissue from women who have undergone breast biopsy or surgery.

objectives: * to prove that optical spectra collected by inserting an optical fiber probe into breast tissue through a biopsy needle can be of adequate quality to render a spectroscopic diagnosis. outline: optical spectra are acquired from ex vivo samples of normal and malignant breast tissue using diffuse reflectance, fluorescence, and raman spectroscopy. tissue spectra are measured using a portable clinical spectroscopy device with front- and side-viewing optical fiber probes that are inserted into the breast tissue through a hollow biopsy needle. after the probes are withdrawn through the needle, cutting biopsies are obtained and the tissue is marked at the site of the spectral measurements. the biopsy specimens are then fixed in formalin and submitted for histopathologic studies using standard light microscopy techniques (i.e., h\&e staining and ihc). additional histochemical, immunohistochemical, and fluorescent in situ stains may be performed to support the diagnosis or to better understand the spectroscopy results. medical records are reviewed to obtain information from the pathology report on patient demographics, pathological characteristics of the surgical specimen, and clinical indication for the surgical procedure.

Eligibility criteria:
disease characteristics: * discarded normal and malignant breast tissue surgical specimens from women who have undergone excisional breast biopsy, lumpectomy, mastectomy, or breast-reduction surgery at the university hospitals-case medical center * hormone receptor status unknown patient characteristics: * menopausal status unknown prior concurrent therapy: * see disease characteristics

Keywords: breast cancer
preoperative cataract pupillary dilation: inpatient at the ambulatory surgery center vs outpatient dilation prior to arrival at the ambulatory surgery center

Conditions: Pupil Dilation Prior to Cataract Surgery In-patient; Pupil Dilation Prior to Cataract Surgery Out-patient

Summary: this study was done to compare efficacy, safety and efficiencies of various methods of pupil dilation prior to cataract surgery.


Eligibility criteria:
inclusion criteria: * ability to self administer eye or have a helper for the task of administering eye drops. * ability to follow and eye drop administration schedule. * no noted ocular abnormalities. * bilateral cataract surgery anticipated. exclusion criteria: * inability to self administer eye drops or have assistance with eye drop administration. * health problems that would contraindicate self administration of dilating eye drops such as poor cardiovascular or respiratory status.

Keywords: cataract surgery pupillary dilation
lh response to gnrh test in prepubescent girls under 6 years

Conditions: Precocious Puberty

Summary: the project aims to establish the normal lh and fsh response to a standardized gnrh dose in healthy girls below 6 years of age, and compares the normal gnrh response to the gnrh response in girls with early puberty development. the novel data may help to determine whether the girl is in early puberty or not. healthy girls under 6 years of age attending routine examinations including an i.v. line for other causes are included in this study. our examinations also include bone age determination, tanner stage determination, and anthropometric measures (height and weight). 10 healthy girls in each of the following age groups: 7-12 months, 12-24 months, 24-36 months, 36-48 months, 48-60 months and 60-72 months are included.

please refer to the brief summary which covers the study aim, methods and outcome measures.

Eligibility criteria:
inclusion criteria: * endocrinologically healthy girls in the age from 7 months to 6 years * obtained oral and written informed consent from participants parents exclusion criteria: * anamnestic, clinical or laboratory findings that indicate that the subject is suffering from other diseases (eg poorly controlled asthma) or is in a condition which might affect the subject's ability to complete the study or which is likely to affect the parameters under investigation. * current medical treatment apart from prophylactic antibiotics or weak analgesics. * gfr \<50 ml/min/1,73m2 or if absence of previous gfr study: serum creatinine above normal upper age-specific normal range. * clinical signs of precocious puberty

Keywords: precocious puberty gnrh-test
neem lotion with combing for lice

Conditions: Pediculoses; Head Lice

Summary: this was a phase iia randomised, assessor blinded, parallel group study in which half the participants were treated with nice 'n clear neem-based conditioning lotion plus combing with a head louse detection and removal comb and the remainder were treated with nice 'n clear plus combing with a normal grooming comb

neem oil has had a long reputation for killing a wide range of insects, including head lice. several products are marketed with this oil as a named active ingredient, e.g. nice 'n clear neem-based conditioning lotion. this product was developed as an aid to combing out head lice for eliminating infestation but it has been considered possible that the neem oil could act to kill lice and inhibit their eggs from hatching. this study was designed to compare use of nice 'n clear neem-based conditioning lotion when used with two different types of comb. one arm of the study was planned so that participants were combed using a plastic louse detection and removal comb (wet combing with conditioner method), in which it was expected the combing process would play a major role in efficacy. the other arm was planned so that participants were combed using a regular grooming comb, which would normally have little effect for removing head lice from the hair. comparison of the efficacy outcome in the two groups would determine whether the nice 'n clear neem-based conditioning lotion exhibited any effect to eliminate infestation independent of the combing

Eligibility criteria:
inclusion criteria: * males and females who are found to have an active head louse infection, i.e. the presence of live lice. detection combing will be done with a fine-toothed plastic detection comb, until at least one louse is found. * people who give written informed consent and/or, if the participant is below 16 years of age, whose guardian gives written informed consent to participate in the study. assent/verbal assent forms will be required for those between the ages of 4 and 16 years of age. there is no maximum age limit. * participants must be available for the duration of the study i.e. 15 days. exclusion criteria: * people who have been treated with other head louse products within the previous 2 weeks (14 days). * people who have undergone a course of antibiotic treatment using cotrimoxazole, trimethoprim or septrin within the previous 4 weeks, or who are currently taking such a course. * people whose hair has been bleached, colour treated, or semi-permanently waved within the previous 2 weeks, this includes the use of semi-permanent colouring agents. home use wash in/wash out colouring agents are acceptable. * people who have taken part in another clinical study within 4 weeks prior to entry to this one. * females who are pregnant or breast-feeding. * participants who have already taken part in this study. * people who have a known allergy to any of the ingredients of nice 'n clear lotion (including allergy to paraben preservatives) * children under 6 months of age.
venous thromboembolism prophylaxis post cesarean section

Conditions: Bleeding; Venous Thromboembolism

Summary: pregnancy is associated with an overall 5-10 fold increased risk of venous thromboembolism (vte). vte remains the most common cause of maternal death in the developed world. it is up to 10 times more common in pregnant women than non-pregnant women of comparable age. more than a third of pregnancy-related vte occurs during the six weeks after delivery. when compared with vaginal delivery, cesarean delivery further increases the risk of pregnancy associated vte by three-fold.

this is a double blind- a randomized controlled study of prophylactic lmwh in women at low risk for vte following a cesarean section procedure. the sample size is 300 patients, eligible, consenting, and randomized participants will receive once-daily injections of study drug (4,500 iu tinzaparin sodium \[innohep®\] within 12- to 24-hours postpartum and continue for two weeks versus placebo in the other arm and follow for six (6) weeks postpartum. on the day of hospital discharge, bilateral leg imaging with compression, leg ultrasounds, and pelvic vein imaging with mrv will be completed. the primary outcome will be adjudicated, while dvt will be documented on ultrasounds or mrv on the day of hospital discharge. secondary outcomes will include symptomatic dvt and pe, death from pe, major and minor bleeding, and hit during the six-week postpartum period. all outcomes will be adjudicated by an independent committee of experts blinded to study drug allocation.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old. 2. delivered by cesarean section (emergency or planned). 3. signed, informed consent. 4. ready access to a local health service. 5. capable of using tinzaparin. exclusion criteria: 1. at high risk for thromboembolism (any one of the following): * age more than 35 years old * obesity (more than 80 kg) * parity more than 4 * gross varicose veins * current infection * pre-eclampsia * immobility prior to surgery (more than 4 days) * major current disease: including heart or lung disease, cancer,inflammatory bowel disease and nephrotic syndrome. * extended major pelvic or abdominal surgery (e.g. cesarean hysterectomy) * patients with a family history of vte * history of superficial phlebitis 2. more than 36 hours since delivery 3. need for anticoagulation, including: * women with a confirmed thrombophilia * women with paralysis of lower limbs * women with personal history of vte * women with antiphospholipid antibody syndrome (apla) * women with mechanical heart valves 4. contraindication to heparin therapy, including history of heparin induced thrombocytopenia.

Keywords: thromboprophylaxis pregnancy post-cesarian section
safety and feasibility of adrcs (adipose derived regenerative cells) in patients with grade ii hamstring tears

Conditions: Muscle Tear

Summary: to evaluate the safety and feasibility of adipose-derived regenerative cells injected into tears of the hamstring muscle.

the recover clinical trial is a prospective, randomized, multi-center device trial intended to assess safety and feasibility, and inform dose selection in preparation for a pivotal trial. subjects that have grade ii tears of the hamstring will be evaluated for eligibility in this study. part a of the trial will be an open-label, safety, feasibility and dose-escalation study to assess whether the treatment approach (liposuction, cell processing and injection) is feasible in athletic patients at one or both doses of adrcs. part b of the trial is contingent on successful completion of part a and is a multicenter, randomized, double blind trial of both doses of adrcs vs. placebo. in both parts of the study, following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. subjects will then undergo liposuction under general or local anesthesia. lipoaspirate will be processed in the celution system to isolate and concentrate adrcs for immediate intramuscular administration under ultrasound guidance. the first 5 patients of part a will receive 0.2 million cells/kg body weight (maximum of 20 million cells) while the second 5 patients will receive 0.4 million cells/kg body weight (maximum of 40 million cells). if the study is shown to be safe and feasible in part a then patients in part b of the study will be randomly assigned to receive one of two doses of adrcs or a visually-matched placebo in a 1:1:1 ratio. if they receive the placebo they will undergo a liposuction and sham intramuscular injection procedure in which they will receive placebo.part b will receive placebo, 0.2 million cells/kg body weight (maximum of 20 million cells), or 0.4 million cells/kg body weight (maximum of 40 million cells). patients in part a of the study will be followed through to 90 days post-procedure. patients in part b of the study will be followed through to 24 months post-procedure.

Eligibility criteria:
inclusion criteria: * grade ii tears (≥5%) of the hamstring * weakness or inability to use affected muscle * ability to safely undergo liposuction exclusion criteria: * tears restricted to the ligament (i.e. no muscle tear) * known spine or disc disease or sciatic nerve disease * known neuromuscular disease * pregnant or lactating status * any condition requiring immunosuppressive medication or use of systemic steroids * known history of hiv, or has active hepatitis b or active hepatitis c * cancer requiring chemotherapy or resection within the last 5 years (other than basal cell carcinoma)

Keywords: hamstring tear muscle grade adipose cells regenerative celution stem cell liposuction fat
safety and efficacy study of epitope peptide to treat hla-a*24 or a*02-positive advanced solid tumors

Conditions: Solid Tumors

Summary: in this study, the investigators examine using a combination of two types of hla-a\*2402 (or hla-a\*0201)-restricted epitope peptides, which were derived from vegf-r1 and vegf-r2 the safety, immunogenicity, and antitumor effect of vaccine treatment for advanced solid tumor patients who are refractory to standard therapy.

the purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of hla-a\*2402 or hla-a\*0201 restricted epitope peptides (vegf-r1 and vegf-r2) emulsified with montanide isa 51 for advanced solid tumors. in this phase i/ii trial, the investigators examine using a combination of the two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for hla-a\*2402 or hla-a\*0201-positive advanced solid tumor patients who are refractory to standard therapy.

Eligibility criteria:
inclusion criteria: 1. advanced solid tumors that are refractory to standard therapies or that cannot be treated with those due to medical reason. 2. ecog performance status 0-1 3. age between 20 to 85 4. clinical efficacy can be evaluated by some methods 5. no prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within two weeks 6. life expectancy \> 3 months 7. laboratory values as follows 1500/mm3 \ 75000/mm3 15% \< lymphcyte fraction asparate transaminase \< 3 x cutoff value alanine transaminase \< 3 x cutoff value total bilirubin \< 3 x cutoff value serum creatinine \< 2x cutoff value 8. hla-a\*2402 or hla-a\*0201 9. able and willing to give valid written informed consent exclusion criteria: 1. active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia) 2. myocardial infarction within six months before entry 3. breastfeeding and pregnancy (woman of child bearing potential) 4. active and uncontrolled infectious disease 5. concurrent treatment with steroids or immunosuppressing agent 6. other malignancy requiring treatment 7. non-cured traumatic wound 8. decision of unsuitableness by principal investigator or physician-in-charge
application of virtual reality technology to treatment of social anxiety

Conditions: Autism Spectrum Disorder; Social Anxiety Disorder

Summary: the purpose of this study is to compare cbt vr exposure + vr social skills treatment to cbt imaginal exposure + mindfulness, in reducing the severity of social anxiety in adults with autism and social anxiety (sa), to identify characteristics associated with benefitting from the cbt-vr treatment and to assess acceptability and feasibility of the vr intervention for patients receiving it and use findings to improve methods and to prepare for a community based pragmatic trial.


Eligibility criteria:
inclusion criteria: * autism spectrum disorder (asd) (diagnosed by a qualified professional) * verbal and literate in english or spanish * average or greater intellectual ability, based on history and interview * able to operate a computer (windows or mac). exclusion criteria: * current or historical severe mental illness such as schizophrenia, bipolar disorder, or severe depression * intellectual disability or a learning disability that would interfere with participating (e.g., unable to read) * unable use the technology or do not have access to the technology * unable to read

Keywords: virtual reality psychotherapy
myopia progression with freeform myopia control spectacles

Conditions: Myopia, Progressive

Summary: this is a prospective, randomized clinical trial. there will be a total of 180 participants randomized into three groups, group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (cml). group 2 - 60 participants will wear the open ring 1 (or1) lens design. group 3 - 60 participants will wear the open ring 2 (or2) lens design. for each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. all groups will be required to wear spectacles for all waking hours for 12 months. after 12 months, the control group participants wearing cml will be randomised to wear either or1 or or2 lens designs; the group 2 participants will continue wearing the or1 lens for a further 12 months. the group 3 participants will wear or2 or or3 (a modified design of or2) based on their risk of myopia progression for a further 12 months.


Eligibility criteria:
inclusion criteria: participants enrolled in the trial must: * be aged between 6 to 12 completed years (6 and 12 years inclusive), irrespective of gender. * for each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. * be cycloplegic autorefraction spherical component -0.50 d to -4.00d, cylinder no more than -1.50d * be accompanied by parents/guardians who can read and comprehend chinese and give informed consent as demonstrated by signing a record of informed consent. * be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator. * have ocular health findings considered to be "normal". * be correctable to at least 6/9.5 (20/30) or better in each eye with spectacles. * be willing to wear the spectacles provided by the investigators for all waking hours. exclusion criteria: participants enrolled in the trial must not have: * a known allergy to, or a history of intolerance to tropicamide or topical anaesthetics. * had strabismus and/or amblyopia. * anisometropia greater than 1.50d spherical equivalent * had previous eye surgery (including strabismus surgery). * any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. marfan syndrome, retinopathy of prematurity, diabetes. * had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids. * current orthoptic treatment or vision training. * any anatomical, skin or other condition that would impact on the wearing of spectacles. * use of or a need for concurrent category s3 and above ocular medication at enrolment and/or during the clinical trial. * currently enrolled in another clinical trial. * no previous myopia management intervention or treatment within 3 months of enrolment

Keywords: myopia progression open ring myopia control spectacle lens