Kornimate/medical-research-clean huggingface dataset:
double-blind study of safety and immunogenicity of two candidate malaria vaccines in gabonese children

Conditions: Malaria

Summary: gsk biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. the candidate vaccines are designed to offer protection against malaria disease due to the parasite plasmodium falciparum. candidate vaccines containing the rts,s antigen would also provide protection against infection with hepatitis b virus (hbv). this study will evaluate two candidate vaccines. the protocol posting has been updated in order to comply with the fda amendment act, sep 2007.


Eligibility criteria:
inclusion criteria: * a male or female child between 18 months and 4 years of age (up to but not including 5th birthday) at the time of first vaccination. * written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child. * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) exclusion criteria: * acute disease at the time of enrolment. * serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests. * laboratory screening tests for haemoglobin, total white cell count, platelets, alt and creatinine out of range. * planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid. * use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * previous participation in any other malaria vaccine trial. * simultaneous participation in any other clinical trial. * same sex twin. * history of allergic reactions (significant ige-mediated events) or anaphylaxis to previous immunizations. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.

Keywords: parasitic diseases malaria, falciparum malaria coccidiosis
comparison of positive psychotherapy and cognitive-behavioral psychotherapy for depression

Conditions: Depression

Summary: this study evaluates the effects of the positive psychotherapy on depressive symptoms and on happiness compared with regular cognitive behavioral therapy.

positive psychotherapy (ppt) focuses on increasing well-being and positive emotions rather than ameliorating deficits in contrast to standard psychotherapy. a lack of positive emotions, engagement and felt meaning are typically viewed as consequences or mere correlates of depression, while the ppt suggests that these may be causal for depression. therefore building positive emotion, engagement and meaning will alleviate depression. thus ppt may offer a new way to treat and prevent depression. the aim of this study is to compare the effects of the positive psychotherapy on depressive symptoms, life satisfaction and happiness in comparison to standard cognitive behavior psychotherapy (regular cognitive behavioral therapy). 60 mildly to moderately depressed patients are randomly assigned to the positive psychotherapy group or the regular cognitive behavioral therapy group. both treatments (primary intervention group and control group) are conducted in an outpatient group therapy setting with 14 sessions and a duration of 2-hours-per-week in small groups of 6 or 7 patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of depression (major depressive disorder, recurrent: mild to moderate; major depressive disorder, single episode: mild to moderate; dysthymic disorder) * patients should be between age 18 and 60 exclusion criteria: * any current treatment for depression * substance related or alcohol related disorder (within the last 12 months) * panic disorder * manic or hypomanic disorder * psychotic disorder \* refusal to participate in a 14 weeks psychotherapy treatment

Keywords: positive psychotherapy depression happiness
synthetic mesh explant study

Conditions: Herniorrhaphy; Humans; Polypropylene; Polytetrafluoroethylene; Histology; Materials Testing

Summary: the purpose of this study is to determine whether synthetic hernia mesh materials undergo physical and/or chemical changes while in the body.


Eligibility criteria:
inclusion criteria: * age ≥ 18 yrs * previous placement of hernia mesh material * current need for excision of previous mesh placement or current need for intra-abdominal surgical procedure exclusion criteria: * age \< 18 yrs * no retained mesh prosthetic. * non surgical candidate * prisoner
evaluation of the dermal cooling system for the enhanced treatment of benign pigmented lesions and common skin conditions

Conditions: Pigmentation

Summary: the purpose of this study is to evaluate the dermal cooling system for lightening of benign pigmented lesions and to assess additional cosmetic benefits.

this is a prospective, non-randomized, open-label study to evaluate the effectiveness of the dermal cooling system to reduce pigmentation in benign pigmented lesions and to determine if additional cosmetic benefits are achieved.

Eligibility criteria:
inclusion criteria: 1. male or female subjects \> 18 years of age. 2. subject has one or more benign pigmented lesions (e.g., solar lentigines, freckles, seborrheic keratosis), in an area suitable for treatment. 3. subject is willing to have up to 40 treatment sites treated per treatment session depending on the size and nature of the lesions identified. 4. subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes. 5. subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of spf 50 or higher on the treated area for the duration of the study, including the follow-up period, if requested. 6. subject has read and signed a written informed consent form. 7. subject is willing to comply with adjuvant topical regimen, as applicable. - exclusion criteria: 1. physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin color, in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery) 2. use of products containing glycolic acids, retinol, salicylic acid within the previous 2 weeks 3. use of accutane within the previous 6 months 4. artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period 5. scars or tattoos in the location of the treatment sites 6. history of melasma, vitiligo, eczema, or psoriasis in the area of treatment 7. history of melanoma 8. subject is pregnant or intending to become pregnant during the study period 9. subject is lactating or has been lactating in the past 6 months 10. known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, reynaud's disease. 11. history of abnormal wound healing or abnormal scarring 12. inability or unwillingness to comply with the study requirements. 13. current enrollment in a clinical study of any other unapproved investigational drug or device. 14. any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject. -
the broken heart study ii (bhs-ii)

Conditions: Takotsubo Cardiomyopathy

Summary: the goals of this study are as follows: 1. to rigorously establish and characterize heterogeneity in the pathophysiology of takotsubo syndrome (ts). 2. to rigorously test the contribution of ts triggering events and mental stress responsiveness to 1-year prognosis after ts event.

newly admitted patients with a validated diagnosis of takotsubo syndrome (ts; n=106) will be enrolled from 3 large medical centers in the providence, rhode island area. between 2 and 4 weeks after discharge, clinically stable patients will undergo an in-person comprehensive interview to identify the events proximal to the onset of ts symptoms, complete a battery of psychosocial questionnaires and undergo a validated laboratory stress protocol. baseline and reactive changes in measures of autonomic nervous system activity (epinephrine and norepinephrine - primary outcome), and in the secondary outcomes of cardiac vagal control and left ventricular function (ejection fraction; regional and global longitudinal strain assessed with speckle tracking echocardiography) will be assessed. echocardiographic evaluations will be repeated 12 months thereafter together with information on major adverse cerebrovascular events.

Eligibility criteria:
inclusion criteria: * age \>=18 * a new diagnosis of takotsubo syndrome fulfilling mayo clinic criteria * ability to understand and speak english exclusion criteria: * inability or unwillingness to give informed consent * severe cognitive impairment * uncontrolled hypertension * acute psychosis * high suicidal risk * pregnancy * poor echocardiographic window * conditions that would interfere with adherence to study requirements (e.g., ongoing alcohol or substance abuse) * if the participant is clinically unstable
cpx-351 (vyxeos™) for transplant eligible, higher risk patients with myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes

Summary: this is a pilot and feasibility study of transplant eligible, higher risk myelodysplastic syndrome (mds) patients to determine the safety and tolerability of a lower -dose and higher-dose cpx-351 regimen, with secondary objectives including complete remission (cr) rates and proportion of patients proceeding to transplant.


Eligibility criteria:
inclusion criteria: * diagnosis of myelodysplastic syndrome (mds) with an ipss-r score of intermediate, high or very high (see appendix a) and ≥ 5% myeloblasts in the bone marrow. * age 18-70 years. * ecog performance status ≤ 2 (see appendix b) adequate renal and hepatic function as defined below: \*total bilirubin ≤ 2.0 x iuln\* * ast(sgot)/alt(sgpt) ≤ 3.0 x iuln * serum creatinine ≤ 2.0 mg/dl * note: if, in the opinition of the treatment physician, the bilirubin is elevated secondary to hemolysis or gilbert's disease, the patient may be eligible after discussion with the washington university pi. * left ventricular cardiac ejection fraction ≥ 50% by echocardiography or muga. * deemed by the treating physician to be a suitable candidate for cytotoxic induction therapy and an allohct candidate at the time of enrollment. * women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and continuing until 30 days after the last study treatment. * ability to understand and willingness to sign an irb approved written informed consent document (or that of legally authorized representative, if applicable). exclusion criteria: * prior treatment for mds with disease-modifying therapy (conventional or investigational) (i.e. hypomethylator therapy, lenalidomide, or prior aml-like induction therapy intended for the therapy of mds). use of prior growth factor and esa support is permitted. * currently receiving any other investigational agents. * a history of allergic reactions attributed to compounds of similar chemical or biologic composition to cpx-351 or other agents used in the study. * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. * history of wilson's disease or other copper-metabolism disorder. * pregnant and/or breastfeeding. women of childbearing potential must have a negative pregnancy test within 14 days of study entry. * known active viral infection with human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv). patients who are seropositive because of hepatitis b virus vaccine are eligible. patients who are seropositive for hcv but have a negative viral load are also eligible provided that the patient has completed a course of therapy for hcv.
medico-economic interest of the protein s100b in mild head trauma under anti-thrombotics

Conditions: Mild Head Injury; Anticoagulant; Antiplatelet

Summary: head trauma is a common injury in emergency department. investigation to search for complication is guided by the clinical examination and the case history, such as taking anti-thrombotics. cranial computed tomography (cct) is the gold standard to investigate, and is mandatory in case of antithrombotic drugs. recently, some biomarkers have proven their utility to rule-out mild head trauma without cct in the general population. among these biomarkers, s100β protein has been added in guidelines for mild head trauma. some studies have found similar data in population taking anticoagulant or antiplatelet drugs. the investigators aim to prove medical utility of s100β protein in population under antithrombotics, by the reduction of cct use. then, the investigators hypothesize that the add of s100β protein reduces cost of health care in the management of head injury in that population.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old * taking antithrombotic medication (antiplatelet drugs, k vitamin antagonist, direct oral anticoagulants, heparins) * mild head trauma with glasgow coma scale ≥ 13 * trauma occured ≤ 6 hours * agreeing the participation in the study exclusion criteria: * head injury occured \> 6 hours * patient \< 18 years old or under juridic protection * pregnant women * polytrauma * glasgow coma scale ≤ 12 * ancient or actual cerebral ou cutaneous neoplasia

Keywords: mild head injury, traumatic brain injury, traumatic intracranial hemorrhage anticoagulant, antiplatelet, anticoagulant, antithrombotic s100β protein health care cost
study to evaluate the safety and tolerability of two doses of rilonacept in pediatric subjects with active systemic juvenile idiopathic arthritis (sjia)

Conditions: Systemic Juvenile Idiopathic Arthritis

Summary: this study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.


Eligibility criteria:
inclusion criteria include, but are not limited to, the following: * patients aged 4 to less than 21 years who meet the criteria for active sjia * must have been on a stable dose of non-steroidal anti-inflammatory drugs (nsaids) for at least 4 weeks prior to the screening visit exclusion criteria include, but are not limited to, the following: * use of certain medications prior to the baseline visit * history of recurrent infections

Keywords: sjia
radiotherapy for oligometastatic prostate cancer

Conditions: Oligometastatic Prostate Cancer

Summary: the purpose of this phase ii study is to evaluate the outcomes of patients treated with an investigational radiation regimen using stereotactic radiotherapy for oligometastatic prostate cancer and to establish efficacy (producing a desired result or effect) and safety in this setting.

this study will serve as a component of a larger program investigating the benefits of stereotactic radiotherapy in patients with metastatic disease. this particular study will serve as a benchmark analysis. all patients will receive stereotactic radiotherapy directed at metastatic tumors. if primary prostate cancer is active and has not previously been treated with radiation therapy, conventional radiation therapy (6-8 weeks of daily treatment) may be recommended. the metastatic tumor will be treated at the same time. hormone therapy will be recommended for all patients. patients will be asked to complete questionnaires at regular intervals.

Eligibility criteria:
inclusion criteria: * patients with metastatic cancer of the prostate, * patients may have received prior surgery, * prior radiation therapy, androgen deprivation therapy (adt), immunotherapy, bone metastasis directed therapy, or chemotherapy for prostate cancer. exclusion criteria: * end-stage heart disease, * end-stage liver disease, * end-stage renal disease, * end stage pulmonary disease * current brain or central nervous system metastasis.

Keywords: prostate cancer oligometastatic prostate cancer proton radiation
heart rate variability (hrv) testing compared with exercise stress test in hospitalized patients with chest pain

Conditions: Angina Pectoris; Ischemic Heart Disease

Summary: there are many patients hospitalized for chest pain, which don't have high risk features that require invasive coronary angiography, but are considered intermediate risk and for which ischemic heart disease can not be excluded. the current management for these patients is to perform a non invasive test in order to classify their risk. exercise ergometry is a commonly used non invasive test to detect ischemia. that test is non-invasive, and does not involve radiation or intra-venous contrast. the test is limited for many patients, because of un-ability to exercise, or because of non-interpetable electro cardio-graphy (ecg). heart rate variability is well known to be a marker of ischemic heart disease. heart rate variability testing is a non-invasive ecg monitoring technique. the study design is to identify hospitalized patients who are candidates for non-invasive stress testing, and to monitor their heart rate variability for one hour prior to the stress test.

ischemic heart disease is among the leading causes of death and disability in the modern world. effective treatment for cardiac ischemia is based on identification of the proper patients and assigning prompt treatment to those patients. it is not simple identifying the proper patients. there are many patients complaining of typical anginal chest pain without coronary heart disease, and there are many patients with active angina who complain of non-typical symptoms or who don't feel any symptoms. management of hospitalized patients with suspected angina pectoris is based on their complaints, their risk factors and laboratory results (ecg, troponin). they are classified into low-risk, high risk and intermediate. intermediate risk patients usually require additional testing in the hospital in order to re-classify them into high or low risk. heart rate variability is a well-known marker of active cardiac ischemia. the investigators plan to perform a 60 minute heart rate variability monitoring.

Eligibility criteria:
inclusion criteria: * adult patients * hospitalized for chest pain * intermediate probability for ischemic heart disease * selected management strategy is non invasive cardiac stress testing exclusion criteria: * active ischemic symptoms * ecg changes suggestive of myocardial ischemia * troponin elevation on blood tests * atrial flutter * multiple apb's or vpb's on resting ecg

Keywords: ischemic heart disease heart rate variability exercise strss test
iontophoresis in psoriasis

Conditions: Psoriasis; Psoriasis Vulgaris; Skin Diseases

Summary: iontophoresis potentially may be a good alternative to improved delivery of corticosteroids. study investigators propose to use iontophoresis to increase dexamethasone delivery into thick psoriasis plaques. the primary purpose of this study is to assess whether dexamethasone sodium phosphate iontophoresis is an effective local therapy for psoriasis. the objective of the study is to determine the efficacy of dexamethasone sodium phosphate iontophoresis for psoriasis.

subjects who meet the selection criteria will be offered an opportunity to take part in this study. this will be a prospective controlled study. after written informed consent, 20 subjects with symmetric thick plaque psoriasis lesions on the extremities and/or trunk will be enrolled and randomized to receive one activated iontophoresis patch containing dexamethasone sodium phosphate and another inactive control iontophoresis patch containing dexamethasone sodium phosphate on each limb containing a thick psoriatic plaque. members of the research team will apply the patches. after application of the patch, subjects will be asked to return to the clinic in 1 week and 2 weeks. efficacy will be measured at the 1-week and 2-week follow-up visit using a scale for erythema, scale, and thickness called the static physician global assessment (spga) and subject satisfaction to treatment will be measured at the 2 week-follow-up using the psosat questionnaire.

Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age. * subjects with diagnosed plaque-type psoriasis that is stable. * similar psoriasis plaques found on each limb and/or different sides of the trunk. * willingness to attend all scheduled visits and complete the study. * ability to understand and sign an informed consent form. exclusion criteria: * known allergy to dexamethasone or any component of the formulation and iontophoresis components. * change in the use of systemic therapy in psoriasis within 4 weeks prior to applying iontophoresis patches (to allow time for washout). * use of topical therapy (including coal tar, salicylic acid, topical corticosteroids, vitamin d, vitamin a, urea) or recent phototherapy for psoriasis within 2 weeks prior to applying iontophoresis patches (to allow time for washout). * pregnancy or breast feeding women. * any other condition, in the judgement of the investigator, would put the subject at unacceptable risk to participate.

Keywords: skin lesions