Kornimate/medical-research-clean huggingface dataset:
immunogenicity and safety of tetraxim versus local dtp + ipv

Conditions: Pertussis; Diphtheria; Poliomyelitis; Tetanus

Summary: the present clinical study will assess the immunogenicity and reactogenicity of sanofi pasteur's dtap-ipv combined vaccines as a three-dose primary vaccination at 2, 4 and 6 months of age compared to commercially available vaccines in order to meet the requirements for registration of the product in south korea. primary objective to demonstrate the non-inferiority in terms of seroprotection rates (diphtheria, tetanus, polio types 1, 2 and 3) and seroconversion/vaccine response rates to pertussis antigens (pt, fha) of sanofi pasteur's dtap-ipv combined vaccine versus commercially available biken's dtap (cj purified pdt vaccine ™) and aventis pasteur's ipv (imovax polio) monovalent vaccines, one month after the three-dose primary vaccination. secondary objectives 1. immunogenicity: to assess the non-inferiority in terms of seroprotection rates (diphtheria, tetanus, polio types 1, 2 and 3) and seroconversion / vaccine response rates to pertussis antigens (pt, fha) of sanofi pasteur's dtap-ipv combined vaccine versus historical reference (study e2i03294 - france). to assess and describe the immunogenicity of the study vaccines in both groups. 2. safety: to assess and describe the safety of the study vaccines after each dose.


Eligibility criteria:
inclusion criteria: * aged 56 to 70 days inclusive on the day of inclusion * born at full term pregnancy (\>37 weeks) with a birth weight ≥ 2.5 kg * informed consent form signed by the parent(s) or other legal representative * able to attend all scheduled visits and to comply with all trial procedures exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination * planned participation in another clinical trial during the present trial period. * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy. * 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. * chronic illness at a stage that could interfere with trial conduct or completion. * blood or blood-derived products received in the past or planned administration during the trial (including immunoglobulins). * any vaccination in the 3 weeks preceding the first trial vaccination. * history of diphtheria, tetanus, pertussis, poliomyelitis infection (confirmed either clinically, serologically or microbiologically). * previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases with the trial vaccine or another vaccine. * thrombocytopenia or a bleeding disorders contraindicating intramuscular vaccination * history of major neurological diseases or seizures. * febrile illness (rectal temperature ≥ 38.0°c or axillary temperature ≥ 37.4°c) on the day of inclusion. * known family history of congenital or genetic immuno-deficiency.

Keywords: diphteria; tetanus; pertussis; poliomyelitis; acellular
evaluating and predicting response to a single session intervention for self-dislike

Conditions: Depressive Symptoms; Self-Appraisal

Summary: the investigators are testing whether a single session online intervention for self-dislike decreases: 1. fear of self-compassion from immediate pre to immediate post intervention 2. self-hatred immediate pre to 1 month post-intervention 3. individual depression symptoms immediate pre to 1 month post-intervention more than a placebo online single session intervention encouraging the disclosure of feelings in college students. the investigators will also explicitly test whether the following variables are predictors, of at least the smallest variance predicted of interest, of response to treatment vs. placebo on self-hatred: 4. pre intervention self-hatred score 5. screening positive for clinical depression based on self-report 6. immediate pre to post-intervention reduction in fear of self-compassion 7. the investigators will also assess whether any of the variance shared between the treatment and changes in individual depression symptoms immediately pre intervention to 1 month post-intervention is statistically mediated by change in self-hatred from immediate pre intervention to 1 month post intervention


Eligibility criteria:
inclusion criteria: participant is a current college student at the time of study enrollment participant has not previously taken part in the study participant speaks english well enough to complete online intervention activities, which are available in english only participant is comfortable with completing online surveys and programs participant is at least 18 years of age. exclusion criteria: the investigators will exclude participants 3 sds above/below the mean completion time for the study or exit the study prior to randomization for our listed analyses. the investigators will also test whether there's any association between how quickly participants are responding to questions and the variability in their responses. if there is a response time frame (i.e., a series of questions that require answers where timing is measured) where there is a linear relationship between response time and response variability, the investigators may exclude those participants, as response time and response variability should be uncorrelated and a linear association can indicate random responding. this time frame can be identified visually on a graph, and sensitivity tests can be conducted to determine if slight variations on the visual interpretation affect substantive results. the investigators will exclude participants who respond with either copy/pasted responses from text earlier in the intervention (e.g. copy and pasting only text from a previous testimonial slide) to any of free response questions. the investigators will exclude for primary analyses (but may run sensitivity analyses including them) any participants who provide responses of 5 words or fewer to writing prompts that ask for at least 1 sentence or more.

Keywords: depression self-dislike self-compassion symptom level single session
prevention of preterm birth with a pessary in singleton gestations

Conditions: Preterm Birth; Short Cervix

Summary: preterm birth (ptb) is associated with over one million infant deaths annually worldwide. the incidence of ptb in the united states is 11.5% with more than 500,000 deliveries occurring at less than 37 weeks gestation annually. the rate of ptb in the united states increased to 12.8% in 2006, and remains high compared to almost all other developed countries, despite the introduction of many public health and medical interventions designed to delay ptb. weekly treatment with 17-alpha hydroxyprogesterone caproate beginning at 16-20 weeks gestation has been shown to significantly reduce the risk of ptb and is currently recommended for women who experienced spontaneous ptb in a prior pregnancy. however, a strategy for the prevention of spontaneous ptbs in which therapeutic intervention is restricted to women with a previous ptb is likely to have a small effect on the overall rate of prematurity since only about 10% of spontaneous ptbs arise in women with such a history. a major reduction in rates of mortality and morbidity in premature babies will only be achieved with increased precision in the identification of women at risk of spontaneous ptb and through the development of an effective prevention for this complication. transvaginal ultrasound measurement of cervical length is a reliable screening test for prediction of ptb. although treatment with vaginal progesterone is effective in decreasing ptb in women with a short cervix, over 30% of women still experience premature delivery and many women find daily administration of progesterone to be challenging. preliminary studies have suggested that use of an intravaginal pessary may be effective in preventing ptb. if effective this approach would be particularly appealing because of the wide availability of pessaries, ease of use, and low cost. unfortunately, existing studies are inadequate to confirm effectiveness; a well designed, properly powered, prospective randomized trial is warranted prior to widespread implementation in clinical practice. we propose such a trial to study the effectiveness of the pessary in decreasing the incidence of ptb in an inner city philadelphia population.


Eligibility criteria:
inclusion criteria: * 18-50 years of age * singleton pregnancy (limits the participants to female gender) * short cervical length (less than or equal to 25 mm) on second trimester ultrasound at 18-23 6/7 weeks gestation exclusion criteria: * multiple gestation * prior spontaneous preterm birth 16-36 6/7 weeks * ruptured membranes * lethal fetal structural anomaly * fetal chromosomal abnormality * cerclage in place (or planned placement) * vaginal bleeding * suspicion of chorioamnionitis * ballooning of membranes outside the cervix into the vagina or cl = 0 mm on transvaginal ultrasound * painful regular uterine contractions * placenta previa

Keywords: preterm birth preterm delivery short cervix pessary
kidney cancer dna registry

Conditions: Renal Cancer

Summary: this registry will help us develop better methods of: * preventing these cancers * diagnosing these cancers * treating these cancers


Eligibility criteria:
inclusion criteria: kidney cancer case cohort: * must be ≥ 18 years of age and * must be an english-speaker and * must have a diagnosis or suspicion of kidney cancer family member cohort: * must be ≥ 18 years of age and * must be an english-speaker and * must be a blood relative of the proband. family members of probands including mother, father, sisters, brothers, half-sisters, half-brothers, daughters, sons, grandmothers, grandfathers, as well as aunts and uncles are eligible. these individuals need not have kidney cancer, as they will be used for segregation analysis of suspected variants found in the proband; requesting dna from relatives is required. control cohort: * must be ≥ 18 years of age and * must be an english-speaker and * must not have a personal history of cancer, with the exception of nonmelanoma skin cancer, and * must not be a blood relative of any cases or controls enrolled in this study exclusion criteria: * patients who, in the opinion of the primary mskcc clinician or the investigator, have a condition that precludes their ability to provide an informed consent

Keywords: questionnaire dna saliva kidney cancer 13-218 high risk
dissemination of a weight management program among us veterans

Conditions: Body Weight

Summary: this study is being conducted with the veterans affairs national center for health promotion and disease prevention (vancp), which is overseeing the current dissemination of move! (managing overweight/obesity for veterans everywhere), a national weight management program for veterans. it will be based at 10 local sites in the national network of va medical settings and community-based outpatient clinics and will compare two different models for disseminating and implementing move! using a randomized experimental design. one study arm will implement the move\* vets! (volunteer education and tailored self-management and support) model that includes tailored newsletters and peer counseling mi calls and activities, and the other will receive the standard move! program.

the purpose of this research is to study the dissemination and implementation of move!. move! is a national weight management program for veterans that has moved form pilot to full dissemination. overweight and obesity are rapidly rising in the united states and interventions to combat this epidemic are desperately needed. within the va population, approximately 70% of veterans are overweight and or obese. participants will be male and female veterans, aged 21 and over receiving health services at one of the 10 study sites, who qualify for the move! program. we are recruiting a minimum of 800 -1000 veterans to complete a baseline survey at the 10 va sites participating in the study. participants at the 10 va sites are recruited during a primary care visit by primary care provider, they will not be chosen based on the presence or absence of any disease, thus health status will vary. the primary outcome measures will be participation after enrollment into move! and participant weight loss.

Eligibility criteria:
inclusion criteria: * receiving primary care at the one of the 10 selected va centers * bmi 25 or over * 21 years old, no upper age limit * pregnant women may participate in the study with the approval of the va medical staff exclusion criteria: * not a patient at one of the 10 va sites * bmi less than 25 * under 21 years of age * pregnant without medical approval to participate

Keywords: weight diet physical activity veterans move! program
a study of a new type of insulin in participants with type 1 diabetes on insulin injection therapy

Conditions: Diabetes Mellitus, Type 1

Summary: the study will be conducted in participants with type1 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation on blood sugar levels. side effects and tolerability will be documented. the study will be conducted in two parts (part a and part b) to achieve its objectives. participants are expected to enroll in both parts.


Eligibility criteria:
inclusion criteria: * are male or female participants with type 1 diabetes mellitus (t1dm) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin * have a body mass index (bmi) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening * have blood pressure, pulse rate, electrocardiogram (ecg), blood and urine laboratory test results acceptable for the study * have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party) * have venous access sufficient to allow for blood sampling * have provided written consent and are willing to follow study procedures and commit to the study duration exclusion criteria: * are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study * have previously completed or withdrawn from this study * have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study * had blood loss of more than 500 milliliters (ml) within the last month * are treated with a continuous subcutaneous insulin infusion (insulin pump)
multi-center project: building electronic tools to enhance and reinforce cardiovascular recommendations - heart failure

Conditions: Heart Failure

Summary: this study will test an automated, electronic health record (ehr-)embedded alert to improve prescribing of guideline-directed medical therapy for patients with heart failure and reduced ejection fraction (hfref). the investigators have previously tested and implemented this alert at nyu langone health (nyulh), and will now test and implement this alert across three other health systems.


Eligibility criteria:
inclusion criteria: * patient with an encounter visit at participating cardiology practice during the study period * patient with ef of less than or equal to 40% on most recent echocardiogram at the time of visit * patient ages 18-90 exclusion criteria: * pregnancy * ventricular assist device * hospice * cardiac amyloid * medication-specific exclusion for mra: most recent systolic blood pressure less than 105 mm hg, most recent potassium \ 5.5, most recent glomerular filtration rate \< 30 (using mdrd equation), or a documented mra allergy.
comparison of 188-0551 spray versus vehicle spray in subjects with plaque psoriasis (307)

Conditions: Plaque Psoriasis

Summary: this phase 3 study (study 307) has been designed to determine and compare the efficacy and safety of 188-0551 spray and vehicle spray applied twice daily for up to four weeks in subjects with plaque psoriasis. subjects will be instructed to apply the test article (188-0551 spray or vehicle spray) to all psoriasis plaques within the designated treatment area twice daily for four weeks (study day 29), unless the investigator verifies the subject's psoriasis has cleared at day 15, then test article application will be for 2 weeks (study day 15).


Eligibility criteria:
inclusion criteria: 1. subject is male or non-pregnant female and is at least 18 years of age at time of informed consent. 2. subject has provided written informed consent. 3. subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 2% and no more than 10% body surface area (bsa) (excluding the face, scalp, groin, axillae, and other intertriginous areas). 4. subject has moderate to severe plaque psoriasis. 5. subject is willing and able to apply the test article as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. females must be post-menopausal , surgically sterile , or use an effective method of birth control. , women of childbearing potential (wocbp) must have a negative urine pregnancy test (upt) at the baseline visit. exclusion criteria: 1. subject has spontaneously improving or rapidly deteriorating plaque psoriasis. 2. subject has guttate, pustular, erythrodermic, or other non-plaque forms of psoriasis. 3. subject has palmar/plantar psoriasis. 4. subject is pregnant, lactating, or is planning to become pregnant during the study. 5. subject is currently enrolled in an investigational drug or device study. 6. subject has been previously enrolled in this study and treated with a test article. other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
treatment of androgenetic alopecia in males with theradome™ lh80 pro

Conditions: Androgenetic Alopecia

Summary: this is a prospective, randomized double-blind, multi-center study to evaluate the efficacy of low level laser therapy over-the-counter at home device theradome lh80 pro, compared to sham for promoting hair growth in males diagnosed with androgenetic alopecia, and a usability study to assess subject ability to self-assess hair loss and understanding use of the device.


Eligibility criteria:
inclusion criteria: * subject must be diagnosed with androgenetic alopecia with norwood hamilton hair loss scale of iia, iii vertex, iv and v. * subject must have fitzpatrick skin type scale i to iv. * subject must be able to visit clinic site for baseline, 13 week and 26 week study visits and attend 2 visits by phone ( 6 and 19). * hair must be at least 1 inch in length. the hairstyle and length shall be the same for each site visit. subjects are instructed to have their hair cut/styled 1-5 days in advance of a site visit. * be willing to undergo all study procedures including consent for global photographs of hair loss/growth and a 1 mm tattoo to mark the macrophotography site along the indicated transition area of the scalp between the hairline and the balding area of the vertex. * be willing to avoid use of wigs, hairpieces, and/or hair extensions during the study period. * ability to communicate effectively with study personnel. * agrees to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study exclusion criteria: * history of taking propecia or any other hair growth supplements for 12 months prior to enrollment. * history of using rogaine for 6 months prior to enrollment. * subject must have no previous hair transplant, cell treatment, micro needling, or any other treatment in the last 6 months in the scalp. * subject is currently suffering from an active autoimmune disease such as serum lupus erythematosus, or alopecia areata. * currently suffering from dermatologic condition in the treatment area or has a significant scar in the hair treatment area that, in the opinion of the investigator, will make hair growth difficult (such as systemic burns, etc). * subject has a sensitivity or allergy to tattoo ink. * clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator. * employed by sponsor, clinic site, or entity associated with the conduct of the study.
comparison of efficacy of tazarotene 0.045% vs halobetasol propionate 0.01% lotion for treatment of scalp psoriasis

Conditions: Scalp Psoriasis

Summary: psoriasis is a serious, immune-driven illness that affects around 2% of the population and has a wide range of clinical manifestations 1-3 . many patients have localized illness, and topical therapy can be an important part of treatment. tazarotene is the first receptor-selective retinoid for the topical treatment of plaque psoriasis. on application, tazarotene is rapidly hydrolyzed to its main metabolite, tazarotenic acid, which binds to retinoic acid receptors (rars) in the nucleus. tazarotenic acid selectively binds to rars b and g . the predominant type of rar expressed in the human epidermis is rar, indicating that it may be an important mediator of retinoid action in skin. .

topical corticosteroids is commonly used in situations of mild to moderate disease severity. however, long-term safety is still an issue, especially when utilizing stronger formulations,which come with a higher risk of local cutaneous adverse events (aes). telangiectasia, suppression of the hypothalamic-pituitary-adrenal (hpa) axis, and skin shrinkage are some of these negative consequences. by regulating gene transcription, tazarotene normalizes abnormal keratinocyte differentiation, reduces epidermal hyperproliferation, and decreases inflammation, the three pathogenic factors in psoriasis, thereby producing a more normal expression of skin differentiation in psoriatic lesions

Eligibility criteria:
inclusion criteria: * patients between 30-50 years of age, either gender presenting with scalp psoriasis as per operational definition will be included in the study. exclusion criteria: * pustular psoriasis or had used phototherapy, photochemotherapy, or systemic psoriasis therapy within the last four weeks (or biologics within the last three months). * used topical treatment within 14 days prior to the baseline visit or who were diagnosed with skin conditions that would interfere with the interpretation of results were also excluded. pregnant women, women attempting to become pregnant, lactation
muscle strength, physical work capacity and functional performance in individuals with down syndrome

Conditions: Down Syndrome

Summary: this project will evaluate muscle strength and its relationship to everyday function in individuals with down syndrome.


Eligibility criteria:
inclusion criteria: * down syndrome * mild or moderate mental retardation * able to tolerate exercise testing exclusion criteria: * uncontrolled cardiovascular disease * orthopedic limitations to exercise

Keywords: muscle strength