Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of summers non-pesticide lice asphyxiator (l.a.)for the treatment of head lice

Conditions: Head Lice

Summary: a multi-center, randomized, vehicle controlled, double blind clinical trial to evaluate the efficacy and safety of summers non-pesticide lice asphyxiator (l.a.) for the treatment of head lice.


Eligibility criteria:
inclusion criteria: 1. males and females 6 months of age or older. 2. have an active infestation with pediculus capitis, the human head louse, with at least three live lice at baseline. 3. agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study. 4. be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period. 5. subject or guardian is able to understand the new hipaa regulations and sign the hipaa form. 6. subject or guardian has read, understood, and signed appropriate informed consent in english. if english is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language. 7. subject is willing to participate in the study, and abide by the protocol requirements. exclusion criteria: 1. participation in any clinical study within the past 30 days. 2. known hypersensitivity to any ingredient in the product formulation.
high-level laser for provoked vestibulodynia

Conditions: Vulvodynia

Summary: this is a randomized feasibility and acceptability study investigating the effects of laser treatment in women suffering from provoked vestibulodynia compared to a sham-laser treatment. participants will be randomized into the laser group or sham-laser group. the laser group will receive 12 sessions of real high-level laser therapy (hilt) (30-minutes biweekly for 6 consecutive weeks). the sham-laser group will receive 12 sessions (30-minutes biweekly for 6 consecutive weeks) of laser therapy using a deactivated probe. outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain, sexual function, sexual distress, psychological variables and perceived improvement after the treatment.


Eligibility criteria:
inclusion criteria: * moderate to severe pain (≥5/10) during sexual intercourse for at least 3 months * moderate to severe pain (≥5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months * provoked vestibulodynia lasting at least 3 months prior to the study and diagnosed by a standardised gynaecologic exam exclusion criteria: * other causes of vulvo-vaginal pain (e.g. spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy) * post-menopausal state * actual or past pregnancy in the last year * urogynecological condition (e.g. pelvic organs prolapse ≥3, urinary/vaginal infection active or in the last 3 months) * anterior vulvar, vaginal or pelvic surgery (e.g. vestibulectomy, corrective pelvic organs prolapses surgery) * prior use of laser treatments for vulvar pain * expected changes of medication that could influence pain perception (e.g. analgesic, antidepressant) * other medical conditions that could interfere with the study

Keywords: laser provoked vestibulodynia pain sexual dysfunctions
assessment of vulnerability to carotid stenosis by multimodal imaging and cellular and molecular biology analysis

Conditions: Internal Carotid Artery; Atheromatous Stenosis

Summary: cerebrovascular accidents (cva) are the second leading cause of death in france, and the most frequent cause of acquired physical and mental disability. up to 90% of strokes are ischemic, among which about 15% are due to the presence of stenosis of the carotid sinus, at the base of the extracranial internal carotid artery. for many years, only the degree of stenosis was used to assess the risk of stroke, based on the results of original studies from the 1990s. however, the significant improvement in medical treatments since then has significantly reduced the risk of stroke, and the benefits of carotid intervention are becoming increasingly debatable. since the publication of the latest recommendations, the degree of stenosis alone is no longer sufficient to propose an intervention, since most of them will never lead to a neurological event. in addition to stenosis greater than 60%, for the first time, other criteria must be sought to decide on treatment. for example, so-called carotid plaque "vulnerability" criteria, defining patients "at high risk of stroke," should be sought.


Eligibility criteria:
inclusion criteria: * patients with symptomatic or asymptomatic atheromatous stenosis of the internal carotid artery, of a degree ≥ 50%, for which an operative indication is retained * scheduled surgery exclusion criteria: samples collected from patients : * who did not have a preoperative ct angiogram of the supra-aortic trunks * with contraindication to mri * with contraindication to pet scan * with a history of cervical radiotherapy * with uncontrolled diabetes * with a previous homolateral carotid endarterectomy * who has already undergone angioplasty-stenting of the homolateral carotid artery * with a neoplasia considered active / not cured * surgical procedure performed in emergency
a study of mrna-1647 cytomegalovirus vaccine in liver transplant candidates and recipients

Conditions: Cytomegalovirus Infection

Summary: the purpose of this study is to assess the effect of pre-transplant mrna-1647 on post-transplant cytomegalovirus (cmv) virologic outcomes, anti-cmv antiviral use, and clinical outcomes in cmv-seropositive and cmv-seronegative liver transplant candidates who receive transplants and to assess the safety, reactogenicity, and immunogenicity of mrna-1647 in all participants.


Eligibility criteria:
inclusion criteria: * having a negative (that is, cmv-seronegative) or a positive (that is, cmv-seropositive) result using a blood igg assay performed at the central laboratory or a previously documented seropositive result. * listed and anticipated to receive their first deceased donor or living donor liver transplant within 2 months to 12 months of enrollment. * a person of nonchildbearing potential, as defined in the protocol. * for female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 3 months following last study injection. exclusion criteria: * listed as "status 1a" for liver transplant. * hypersensitivity to acyclovir, ganciclovir, or valganciclovir. * previous receipt of a solid organ or hematopoietic transplant. * listed for or anticipated to receive an organ transplant other than liver, either simultaneously or sequentially. * receipt of prior investigational cmv vaccines or participation in another cmv therapeutic study that may interfere with study outcome measures as determined by the investigator. * suspected or known allergic reaction to any component of any mrna vaccine, including mrna-1647, or its excipients. * human immunodeficiency virus (hiv) infection (based on documented testing performed during the transplant evaluation process and no clinical suspicion of hiv infection). * prior (ever) receipt of a stem cell transplant (peripheral blood stem cell, marrow, cord blood). * any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. note: other inclusion and exclusion criteria may apply.

Keywords: mrna-1647 vaccine liver transplant cmv human herpesvirus cytomegalovirus vaccine cytomegalovirus infections cytomegalovirus disease cytomegalovirus virus disease infection viral dna virus infections messenger rna
study of aerosolized sargramostim in treating patients with melanoma metastatic to the lung

Conditions: Melanoma (Skin); Metastatic Cancer

Summary: rationale: colony-stimulating factors, such as sargramostim, may help the body's immune system to kill cancer cells. giving sargramostim in different ways may kill more cancer cells. purpose: phase ii trial to study the effectiveness of sargramostim given as a breathing treatment for treating patients who have melanoma that is metastatic to the lung.

objectives: i. determine the therapeutic effects of aerosolized sargramostim (gm-csf) in terms of progression free survival at 2 months and median survival rate in patients with metastatic melanoma to the lung. ii. determine the immunomodulatory effects of this treatment regimen in this patient population. iii. assess the quality of life in terms of physical and personal concerns of these patients treated with this regimen. outline: patients receive aerosolized sargramostim (gm-csf) over 10-15 minutes twice daily for 7 days. treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline and prior to course 5. patients are followed every 2 months for at least 1.5 years.

Eligibility criteria:
disease characteristics: histologically confirmed melanoma with radiographic evidence of prior or active involvement of the lung or pleura measurable disease at least one lesion with at least one dimension in diameter of at least 10 mm on ct scan or mri no non-measurable disease including the following: bone lesions leptomeningeal disease ascites pleural or pericardial effusion inflammatory breast disease lymphangitis cutis or pulmonis unconfirmed abdominal masses not followed by imaging cystic lesions patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: at least 12 weeks hematopoietic: absolute neutrophil count at least 1,000/mm3 platelet count at least 75,000/mm3 hemoglobin at least 8.0 g/dl hepatic: bilirubin no greater than 2 times upper limit of normal (uln) ast no greater than 3 times uln renal: creatinine no greater than 2.5 times uln cardiovascular: no new york heart association class iii or iv heart disease other: no uncontrolled infection not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: at least 2 weeks since prior biologic or immunotherapy no other concurrent biologic or immunotherapy chemotherapy: at least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) no concurrent chemotherapy endocrine therapy: at least 2 weeks since prior corticosteroids no concurrent systemic glucocorticosteroids radiotherapy: at least 2 weeks since prior radiotherapy no concurrent radiotherapy surgery: not specified other: no concurrent immunosuppressants

Keywords: stage iv melanoma recurrent melanoma lung metastases
gender related differences in the acute effects of delta-9-tetrahydrocannabinol in healthy humans: sub-study i

Conditions: Cannabis

Summary: the purpose of the study is to characterize the acute effects of cannabinoids in women relative to men and to begin probing the mechanisms that may underlie gender differences.

to characterize the acute effects of oral dronabinol (10 mg capsule) in women relative to men and to begin probing the mechanisms that may underlie gender differences.

Eligibility criteria:
inclusion criteria: * at least one lifetime exposure to cannabis * good physical and mental health exclusion criteria: * cannabis naive individuals * major current or recent stressors * taking estrogen supplements or oral contraceptive pills (for women) * sesame oil allergy
evaluation of a tdap-ipv (tetanus, diphteria, pertussis and inactivated polio) vaccination remedial strategy on vaccination coverage in patients 65 years of age or older

Conditions: Vaccination

Summary: in france, vaccination coverage is insufficient (in 2002, 71.2% coverage for tetanus, 41.9% for poliomyelitis and 33.7% for diphteria). these numbers decrease significantly with age: coverage for people aged over 65 was 60.5%, 13.3% and 10.5% for tetanus, poliomyelitis and diphteria coverage respectively. the primary objective of this study is to evaluate the impact of a hospital based vaccination remedial strategy for tdap-ipv (tetanus, diphteria, pertussis and polio vaccine) in patients 65 years of age or older. secondary objectives are to measure the vaccination coverage of patients aged 65 years or older hospitalised in a medical ward in our hospital, to evaluate their knowledge of their vaccination coverage, and to evaluate the socio-demographic factors associated with vaccination coverage.


Eligibility criteria:
inclusion criteria: * patients aged 65 years or older * patients capable of understanding and giving informed consent to participate in the study * valid social security coverage exclusion criteria: * patients under judicial safeguard measures * refusal to participate in the study * vaccination contra-indication * patient already included in the study

Keywords: vaccination coverage
the spinal navigation trial - surgical navigation or free hand technique in spine surgery

Conditions: Scoliosis; Kyphosis

Summary: the spinal navigation trial (spinav) is a randomized controlled trial (rct) evaluating the use of computer-assisted navigation in surgery for spinal deformity

spinal deformity is a common reason for spinal surgery at youth. in addition, the incidence of surgery for spinal deformity in older adults is increasing. spinal deformity surgery is by far the most complex spine surgery. one complexity lies in the correct placement of implants in the severely deformed spine. today, the most common surgical procedures for spinal deformity involve placement of screws in the vertebral pedicle in the instrumented part of the spine. this gives good bone purchase, which is important for deformity correction. the pedicle is narrow and misplaced pedicle screws can result in vascular, pulmonary or neural injuries, or inadequate bone purchase. compared to the conventional free-hand surgical technique, which relies on the knowledge of anatomy, computer-assisted navigation using intraoperative 3d imaging has been shown to improve screw placement accuracy and reduce complications due to screw misplacements. as a consequence, navigation may also reduce the frequency of postoperative revision surgery compared to free hand. however, navigation still takes time, and is associated with higher intraoperative radiation than the free hand technique. as of yet, the majority of data in this area are based on retrospectively collected series, and some prospectively collected series, while randomized controlled trials on spinal deformity are lacking. in this randomized controlled trial the accuracy of pedicle screw placement using augmented reality surgical navigation (arsn), infra-red surgical navigation (irsn) and conventional free-hand technique will be investigated. patients of age 12 years and older with spinal deformities are randomized into one of the three surgical techniques mentioned above. the primary outcome variable is pedicle screw placement accuracy at 1st attempt assessed using the gertzbein scale. data from the navigated groups (asrn and irsn) will be analyzed together, and compared with the free hand groups analyzed together. the asrn and isrn groups will also be compared with their respective free hand groups.

Eligibility criteria:
inclusion criteria: * written informed consent by patient or legal guardian * age 12 years and older * spinal deformity surgery exclusion criteria: * unable to give informed consent * surgery without pedicle screws * previous surgery with pedicle screws in the planned surgical area
the accumbo home blood pressure trial

Conditions: Hypertension,Essential

Summary: aim of the study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system,a smartphone patient app and a home blood pressure monitor.

despite the extensive knowledge of the importance of treating and thus preventing complications of hypertension, the incidence of high blood pressure is increasing, and it is still the main cause of cardiovascular disease and premature death, partly due to deficiencies in preventive care and control of the disease in an aging world. blood pressure values obtained by self-measurement at home (hbpm) have been shown to predict the cardiovascular prognosis equally well as or better than blood pressure values obtained in the clinic (cbpm) in several observational studies. aim of the present study was to investigate a new clinical medical system for treatment of hypertension with a clinical decision system and a electronic health record, a patient app and a home blood pressure monitor. " the patient app and the doctor's record reflect each other and basically contain the same information. doctors can treat their patients remotely and the patients are able to manage some health issues by themselves by using the applications. some patients need the physical examination. we therefore included patients after a so-called triage step with medical questions.

Eligibility criteria:
inclusion criteria: * primary hypertension * smartphone at home exclusion criteria: * secondary hypertension, * previous stroke, * myocardial infarction, * known heart failure, * known cardiac arrhytmia, * known servere renal failure, * known dementia

Keywords: home blood pressure monitor telemedicine mhealth ehealth
study of tesetaxel in japanese patients with solid tumors

Conditions: Advanced Solid Tumors

Summary: tesetaxel is an orally active tubulin-binding inhibitor of the taxane class. evaluation of tesetaxel in japanese patients has been limited. this study is being conducted to determine the maximum tolerated dose and safety of tesetaxel administered orally once every 21 days to japanese patients.


Eligibility criteria:
primary inclusion criteria: * at least 20 years of age * morphologic or cytologic confirmation of an advanced or metastatic solid tumor malignancy, not to include lymphoma, for which no standard therapy exists or for which resistance or intolerance to standard therapy has developed * ecog performance status not more than 1 * adequate bone marrow, hepatic, and renal function * willing to remain hospitalized for at least 10 days following tesetaxel administration in cycle 1 * at least 4 weeks and recovery from effects of prior surgery or other therapy with an approved or investigational agent, with resolution of any toxicity to not more than grade 1 primary exclusion criteria: * brain metastasis or leptomeningeal disease * significant medical disease other than cancer * neuropathy greater than grade 1

Keywords: advanced solid tumors
a study evaluating the drug levels of iplimumab given under the skin alone and in combination with nivolumab in multiple tumor types

Conditions: Tumor

Summary: a study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * men and women must follow methods of contraception as described in the protocol part 1 arms a and b: metastatic melanoma - previously untreated, histologically confirmed stage iv melanoma, as per american joint committee on cancer (ajcc) staging system v.8.0 part 1 arm a:advanced/muc - participants with histologically or cytologically confirmed urothelial carcinoma. part 1 arm a: advanced hcc * participants with histological confirmation of hepatocellular cancer (hcc) part 2 arm a: metastatic nsclc - participants with histologically confirmed stage iv or recurrent non small cell lung cancer (nsclc) part 2 arm b: advanced or metastatic rcc * histological confirmation of renal cell carcinoma (rcc) * ecog performance status of 0 or 1 and for rcc (part 2 arm b), karnofsky performance status ≥ 70% exclusion criteria: - history of allergy or hypersensitivity to study drug components part 1 arm a: advanced hcc * history of hepatic encephalopathy or evidence of portal hypertension * active coinfection with hepatitis d virus infection in participants with hbv part 2 arm a:metastatic nsclc - participants with known alk translocations and egfr mutation that are sensitive to available targeted inhibitor therapy other inclusion/exclusion criteria apply.

Keywords: lung cancer, renal cancer, bladder cancer, skin cancer, liver cancer
folic acid clinical trial: follow up of children (fact 4 child)

Conditions: Autism Spectrum Disorder; Asthma; Executive Dysfunction; Emotional Problem; Behavioural Problem; Pre-Eclampsia; Death

Summary: fact 4 child is a follow up study of mothers who participated in the folic acid clinical trial (nct01355159) and their children at 4-6 years of age to determine the effect of high dose folic acid supplementation on social impairments associated with autism spectrum disorders (asds), and deficiencies in a range of executive function and emotional and behavioural problems in young children, and the risk of death.

the folic acid clinical trial (fact) was developed to conclusively determine the effect of high dose folic acid supplementation in pregnancy on the prevention of preeclampsia in a randomized controlled trial (rct) design. the primary objective of the fact 4 child study is to examine the effect of maternal folic acid supplementation in pregnancy on the risk of social impairments, as well as executive function, emotional and behavioural problems associated with autism spectrum disorders (asd) and other developmental disorders, and death in offspring aged 4-6 y of mothers recruited to the cihr funded fact. the effect of folic acid supplementation throughout pregnancy may potentially have an impact on both the mother and her offspring, which highlights the importance and relevance of this study to the management of women with preeclampsia. results of this study will allow care providers to have the evidence of potential effects of high dose folic acid that can then be discussed; allowing women to make an informed choice about their management and care.

Eligibility criteria:
inclusion criteria: 1. capability of participant to comprehend and comply with study requirements 2. mother participated in fact exclusion criteria: 1. confirmed spontaneous termination (miscarriage) or elective termination or stillborn 2. confirmed death of offspring at 6 weeks postpartum and/or at discharge from hospital

Keywords: neurological autism asd behaviour folic acid pre-eclampsia asthma executive function