Kornimate/medical-research-clean huggingface dataset:
testing an intervention in irritative contact dermatitis

Conditions: Contact Dermatitis; Contact Dermatitis Irritant

Summary: an eczematous reaction is an inflammatory intolerance response of the skin. in acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system.

an eczematous reaction is an inflammatory intolerance response of the skin. in acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system. therefore, the aim of this study was to see if omega cream, as proposed by its mechanism of action, could improve sls induced contact dermatitis.

Eligibility criteria:
inclusion criteria: * healthy volunteers who gave written informed consent exclusion criteria: * · skin cancer * skin disease * skin damage on measurement sites * use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial * use of drugs that may cause photosensitivity * use of emollients three days prior the inclusion in the trial * non-adherence to the trial protocol * exposure to artificial and excessive natural ultraviolet (uv) radiation * pregnancy and lactation * history of vitiligo, melasma and other pigmentation and photosensitivity disorders * immunosuppression * allergic or irritant reactions to the constituents of the cream
phase 1 study of shj002 sterile ophthalmic solution in pediatric subjects

Conditions: Myopia

Summary: this is a single-center, open-label, first-in-human dose-escalation study of shj002 ophthalmic solution in children. (part 1) three (3) subjects will receive each concentration of shj002 for 3 days in an escalation design in one eye. (part 2) a group of 9 additional children will receive the highest tolerated concentration for 28 days.


Eligibility criteria:
inclusion criteria: * non-cycloplegic sphere from +1.50 to -4.75 diopters in one or both eyes. * a minor able to complete all study assessments and comply with the protocol and has a parent or caregiver willing and able to follow study instructions, comply with the protocol and attend study visits with the subject as required, in the opinion of the investigator. * literate and able to orally communicate. exclusion criteria: * non-cycloplegic sphere worse than -4.75 diopters * axial length \> 26 mm * hyperopia worse than +1.50 diopters * anisometropia (difference of myopic power \>2.00 d). * astigmatism \> 1.5 d. * intraocular pressure \> 21 mm hg or \< 6 mm hg.

Keywords: myopia
study of mantle cell lymphoma treatment by ribvd

Conditions: Mantle Cell Lymphoma

Summary: study of first line mantle cell lymphoma treatment by rituximab, velcade, bendamustine and dexamethasone schema in patients older than 65 years or 18 to 65 years old who cannot or refuse receive conditioning regimen followed by autograft.

demonstration of improvement of progression-free survival (pfs) compared to literature data. 6 months prolongation equal 24 months compared to 18 months obtained whatever the current regimen and in particular compared to rchop regimen

Eligibility criteria:
inclusion criteria: * mantle cell lymphoma cd20 positive * untreated patients * 65 ans years old patients or 18 to 65 years old patients who can't or refuse receive conditioning regimen followed by autograft. * stages ann arbor ii, iii or iv, * ecog performance status of 0, 1 or 2 * without history of neoplasm, except in situ cervix carcinoma and cutaneous basal cell epithelioma, or in complete remission since 3 years, * without drug contraindication used in the schema (rituximab, benda-mustine, velcade, dexamethasone), * without heart insufficiency or stabilized, * with the following biological values limits except if pathological values are due to medullary invading or hypersplenism, hepatic involvement) :pnn more than 1 g/l, platelets more than 50 g/l,transaminases (sgot and sgpt) and alkalin phosphatases alcalines less than 4 x normal,bilirubin less than 3 x n,- clearance creatinemia more than 20 ml/min * hepatitis b negative serology unless the seropositivity is clearly linked to a vaccination. * can be regularly followed * who signed the informed consent, * affiliated to a national insurance or such a same scheme . exclusion criteria: * other type of lymphoma than mantle cell lymphoma according to oms 2008 classification * patients in relapse, except those in relapse due to localized stade who only received locoregional irradiation or splenectomized, * central nervous system localization in particular meninge, * drug used in the schema contraindication rituximab , bendamustine , velcade® or dexamethasone * non stable diabetes, * hiv positive or active hepatitis c or b * ecog performance status equal or more than 3 * peripheral neuropathy, whatever its origin, rated more than 2 from nci * non stabilized heart insufficiency, * patient who can't receive hyperhydration in order to treat tumoral lysis syndrome or in prophylaxis, * patient who can't, whatever the reason, be regularly followed, * major patient who are on legal protection, or can't give their consent * patient who has not signed the informed consent

Keywords: mantle cell lymphoma rituximab bendamustine velcade dexamethasone
a study of azithromycin in hiv-infected patients

Conditions: Bacterial Infections; HIV Infections

Summary: to assess the dose proportionality of azithromycin concentrations and toleration when delivered in tablet formulation to hiv-infected patients. the need exists to further assess the antibacterial agent azithromycin at differing doses in an hiv-infected population.

the need exists to further assess the antibacterial agent azithromycin at differing doses in an hiv-infected population. patients are randomized to receive azithromycin at 1 of 2 doses in a two-treatment, two-period, cross-over study. dosing visits are separated by at least 14-day wash-out periods.

Eligibility criteria:
inclusion criteria patients must have: * hiv seropositivity. * cd4 count \<= 500 cells/mm3. * no active aids opportunistic infection. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * other active intercurrent illness. * any condition possibly affecting drug absorption (e.g., ulcers, gastrectomy, hiv-associated enteropathies. * signs or symptoms of severe illness that would preclude study participation. * known allergies to macrolide antibiotics. patients with the following prior condition are excluded: clinically important change in baseline status within 4 weeks prior to study entry. prior medication: excluded: * investigational drugs including treatment ind drugs within 4 weeks prior to study entry. known drug or alcohol dependence.

Keywords: azithromycin bacterial infections
diurnal variation of tear meniscus and tear osmolarity

Conditions: Dry Eye

Summary: this study is to determine the diurnal variation of tear meniscus and tear osmolarity in normal subjects and dry eye patients.

this study is to determine the diurnal variation of tear meniscus using oct and tear osmolarity using tearlab's osmolarity system in normal subjects and dry eye patients.

Eligibility criteria:
inclusion criteria 1. is at least 18 years old and has full legal capacity to volunteer; 2. has read and signed the irb informed consent document; 3. is willing and able to follow participant instructions; 4. has clear corneas; 5. has 20/100 uncorrected visual acuity or better; 6. is not a hard (or rigid gas permeable) contact lens wearer within the last year; 7. was a soft contact lens wearer, but stopped wearing at least 1 week ago; 8. has dry eye according to the study definition of des (study subjects). exclusion criteria 1. has any systemic disease affecting ocular health except for sjögren's syndrome; 2. is using any systemic or topical medications that will affect ocular health except for artificial tears; 3. has an active ocular disease other than des, meibomian gland disease or sjögren's syndrome 4. has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities; 5. has limbal or bulbar injection or corneal staining that was clinically significant, which are not due to des; 6. has worn rigid gas permeable lenses within 1 year; 7. has had surgery or an eye injury within 6 months.

Keywords: dry eye tear meniscus tear osmolarity
chronic kidney disease-education (ckd-edu)

Conditions: Chronic Kidney Diseases

Summary: the investigators are conducting a study to see which program better helps older patients with kidney disease choose their treatment. investigators are also investigating if either program can reduce the number of hospital or emergency room visits in the first 6 months of the study, as well as potentially improve end-of-life care for older adults. half of the participants will receive program a, while the other half will receive program b. investigators will compare the two groups to see which participants feel better prepared about their kidney therapy decisions, experience improved end-of-life care, and have fewer emergency room visits and hospital admissions. participants in program a will receive information from the national kidney foundation and meet with a kidney therapy educator. participants in program b will get information about kidney disease treatment and meet with a decision-support specialist who's an expert in decision-making.

older adults ≥75 years represent the fastest-growing population to initiate dialysis in the us; despite the life-altering effects of dialysis on quality of life, dialysis is often presented as a default without considering patient preferences, prognosis, and alternative options such as conservative kidney management. this study will test the first palliative care intervention for older patients with advanced chronic kidney disease to improve the kidney therapy decision-making process. this research not only has the potential to help thousands of older patients with advanced chronic kidney disease who often have unanswered questions, unmet information needs, and restricted opportunities to share personal treatment preferences with their nephrologists but also has the possibility of creating new models of collaborative care by integrating palliative care into routine nephrology care.

Eligibility criteria:
inclusion criteria: * age ≥ 75 years old * has advanced kidney disease with kidney function less than 30% * speaks english * has not yet made a dialysis decision exclusion criteria: * has already decided on dialysis or active medical care without dialysis. * has already been seen by a palliative care (pc) clinician for kidney-related issues or is enrolled in hospice * currently on dialysis * unable to provide informed consent or complete verbally administered surveys due to health, sensory, or cognitive impairment.
simulated clinical use testing on safety lancets (test b)

Conditions: Needle Stick

Summary: a simulated clinical use testing on the htl-strefa's safety lancets

this study aims to evaluate the safety of the use of the safety lancets: haemolance plus, prolance and medisafe solo in the prevention of nsi and to evaluate the user's opinion with regards to the handling characteristics of the medical devices. the simulated use clinical study will involve healthcare professionals (hcps) who routinely use safety lancets to collect blood samples.

Eligibility criteria:
inclusion criteria: the inclusion criteria for hcp and lay person evaluators have been chosen based on fda guidance: * evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts) * evaluators will be united states (us) residents * evaluators can read, write, and speak english * evaluators are at least 18 years old * evaluators are able to understand and provide signed consent for the study * evaluators are willing to comply with the study protocol, including being willing to answer questions and complete questionnaires. * evaluators have no concerns about the ability to perform the simulated skin pricking. exclusion criteria: individuals will be excluded if: * they do not routinely use safety lancets to collect capillary blood samples, * they cannot read, write, and speak english, * they or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or * they have participated in a product evaluation

Keywords: needlestick needlestick injury safety lancet sharps injury prevention capillary blood sampling
evolution of plasma lipid profile in patients with hiv1 who change atripla to eviplera compared to continue with atripla

Conditions: HIV-1

Summary: to compare the lipidomic profile in patients with hiv-1 with viral suppression changing efavirenz + emtricitabine + tenofovir (atripla) to rilpivirine + emtricitabine + tenofovir (eviplera®) versus a group of patients that continue with atripla®.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or above * patients infected with hiv-1 * patients treated with atripla at least the last 6 months. * patients with virologic suppression (hiv rna \<50 copies / ml) for at least the last 6 months. * women of childbearing potential must use contraception double barrier. * voluntary signature of informed consent exclusion criteria: * any acute or chronic (besides chronic hiv-1) disease that could interfere with the analysis of lipidomic * women pregnant or lactating * abuse of alcohol or other drugs * body mass index (bmi)\> 25 * use of drugs that may affect lipid metabolism (lipid-lowering drugs, steroids ...) * patients unable to understand the study protocol or any other condition that in the investigator's opinion could jeopardize compliance with the protocol * history or presence of allergy to any of the study drugs or their components
effect of a micro-finance-based intervention for the prevention of intimate-partner violence and hiv

Conditions: HIV; AIDS; Domestic Violence

Summary: the high rates of hiv infection in women have brought into sharp focus the problem of violence against women. there is a growing recognition that women and girls' risk of and vulnerability to hiv infection is shaped by deep-rooted and pervasive gender inequalities violence against them in particular. the links between intimate partner violence and hiv/aids are explained by biological as well as sociocultural and economic factors.


Eligibility criteria:
inclusion criteria: * at least 18 years old; * must plan to reside in study areas for the next 12 months * must visit camp at least 1 time per week * must provide contact information of friend or family member exclusion criteria: * unwilling to provide local information * psychological disturbance, cognitive impairment or threatening behavior
prevalence study and regular practice among general practitioners in populations at risk of chronic obstructive pulmonary disease (copd) in latin america

Conditions: Chronic Obstructive Pulmonary Disease

Summary: puma is an observational, multicentre, multinational, cross-sectional study with primary care physicians (primary care, general and family physicians). participants will be selected sequentially among patients at risk for chronic obstructive pulmonary disease (copd) who attend primary care consultation (primary care, general and family physicians). the inclusion visit will be a regularly scheduled or spontaneous consultation for patients, and this appointment with the physician will not depend on the study. during the appointment, data will be collected from the patient and the physician.

prevalence study and regular practice (diagnosis and treatment) among general practicioners in populations at risk of copd in latin america

Eligibility criteria:
inclusion criteria: * men or women aged more or equal than 40 * current or former smokers and/or patients exposed to biomass combustion: cigarettes: more or equal than 10 packs/year; pipes: more or equal than 50 pipes/year; cigars: more or equal than 50 cigars/year; combustion: more or equal 100 hours/firewood/year exclusion criteria: * pregnancy * patients with contraindications for spirometry * physical or mental disability rendering the patient unable to undergo a spirometry test and to contribute data to the study * heart rate ≥ 120 beats by minute * patients currently undergoing treatment for tuberculosis * a patient who is participating in an interventional clinical trial or was previously included in this study

Keywords: copd smokers primary care
genetics of pediatric-onset motor neuron and neuromuscular diseases

Conditions: Spinal Muscular Atrophy; Charcot-Marie-Tooth Disease; Muscular Dystrophy; Spinal Muscular Atrophy With Respiratory Distress 1; Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Neuromuscular Disease; Peroneal Muscular Atrophy

Summary: the goal of this study is to establish a genetic registry of patients with early-onset motor neuron and neuromuscular diseases. the investigators will collect samples from patients with a motor neuron or a neuromuscular disorder and their family members. the samples to be collected will be obtained using minimally invasive (whole blood) means. the research team will then extract high quality genomic dna or rna from these samples and use it to identify and confirm novel gene mutations and to identify genes which regulate the severity of motor neuron/neuromuscular diseases.

diseases affecting the motor unit--which is composed of the motor neuron, its myelin sheath and its innervated muscle fibers--are a diverse, heterogeneous group having heterogeneous clinical presentations and genetic causes. many of these disorders have a inherited component. in some cases, the genetics underlying a given neuromuscular/motor neuron disease, like spinal muscular atrophy (sma) or duchenne muscular dystrophy, are well characterized. there are, however, disorders whose genetic basis has yet to be determined or genetically characterized diseases which harbor novel mutations. the purpose of this genetic registry is to catalogue early-onset motor neuron and neuromuscular disorders and to determine their genetic bases. with samples obtained from this registry, the investigators will be able to provide a genetic diagnosis for a specific neuromuscular/motor neuron disease which will lead to better care for those patients affected by these diseases. many of these disorders have a wide spectrum of phenotypic variability. for example, the severity of sma is quite variable even though it is caused by the loss of a single gene, i.e. survival motor neuron 1 (smn1). the number of copies of the duplicated gene survival motor neuron 2 (smn2) dictates phenotypic severity in sma. in this study, the research team will also identify potential modifiers of phenotypic severity for specific disorders like sma and charcot-marie-tooth (cmt) disease. with the identification of novel modifier genes, the investigators will be able to more accurately predict disease outcomes and the investigators will also have novel targets for the development of therapeutic agents for these diseases.

Eligibility criteria:
inclusion criteria: * diagnosis of motor neuron/neuromuscular disease confirmed by neurologist * be seen by one of the study investigators exclusion criteria: * not seen by one of the study investigators

Keywords: distal hereditary motor neuronopathy
icbt for children and adolescents with obsessive-compulsive disorder ii

Conditions: Psychotherapy Intervention Evaluation

Summary: internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 6 to 18 years. sessions are verified with teleconferencing with an psychotherapist, children and their parents. the psychotherapy is supported by an app and a wristband to obtain psychophysiological data. the investigators have already successfully performed a feasibility study.the goal of the current proposal is to develop an internet and smart phone delivered cbt (icbt) for the treatment of pediatric ocd on the bases of the feasibility study. internal testing on icbt therapy package and developmental workchanges has been done. the investigators are now evaluating effectiveness in an rct.

in this study the investigators test effectiveness of an internet-based therapy approach for children with obsessive-compulsive disorders in an rct design with a waiting control group. the investigators are planninng the investigation of 20 patients in each group.therapy is verified by experts via teleconferences and a therapy app. outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). for the waiting list-group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up i) and 64 weeks after the first randomization (follow-up ii).

Eligibility criteria:
inclusion criteria: * children and adolescents (ages 6-18) with a primary dsm-5 obsessive-compulsive disorder and at least 1 primary caretaker * german-speaking (child \& caretakers) * family home equipped with broadband connection and appropriate computer, monitor, hd webcam, and speaker and smart phone * written informed content of the child and his caretaker * ocd as highest treatment priority exclusion criteria: * iq below 70 * not speaking and understanding german * a psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality, psychosis or any other psychiatric disorder that requires acute treatment

Keywords: cognitive-behavioral psychotherapy obsessive-compulsive disorder internet-based
phase iii cat-pad follow-on study

Conditions: Cat Allergy

Summary: the purpose of this study is to evaluate the continued effectiveness and safety of cat-pad in cat allergic subjects for up to five years after the start of administration of treatment. the study is an optional follow-up study to a phase iii double-blind, placebo controlled, cat-pad study; no further investigational product is administered.


Eligibility criteria:
inclusion criteria: * previously completed clinical study cp007 \[nct01620762\] exclusion criteria: * started allergen therapy since completing cp007 * institutionalised due to a legal or regulatory order