Kornimate/medical-research-clean huggingface dataset:
video-based family therapy for peripartum depression in home visited mothers

Conditions: Peripartum Depression

Summary: this pilot study will explore the feasibility and acceptability of implementing a family-based treatment, using hipaa-compliant video-based communication technology, for adolescents (pregnant and post-delivery) with peripartum depressive symptoms within the context of home visiting.

the purpose of the pilot study is to partner with two federal maternal, infant and early childhood home visiting (hv) program sites to implement a family-based treatment for depression, using hipaa-compliant video-based communication technology, in adolescent mothers (pregnant and post-delivery). this implementation-effectiveness hybrid trial includes depressed adolescent mothers and their adult family members. it has three aims: 1. explore the feasibility of integrating the treatment model into two federal hv program sites in new hampshire. 2. test the acceptability of the treatment model among depressed adolescent mothers and their families. 3. explore preliminary impacts of the treatment on maternal depressive symptoms and parenting attitudes, family emotion regulation, and family functioning at two months post-intervention.

Eligibility criteria:
home visitor inclusion criteria: 1. willingness to participate in the study; 2. intention to remain in current job for at least 12 months; and 3. fluency in english: the training, treatment model, implementation meetings, and supervision sessions will be carried out in english. family inclusion criteria: 1. adolescent mothers, ages 13-25, in the first trimester of pregnancy through eighteen months postpartum; 2. adolescent mothers with edinburgh postnatal depression scale scores of ≥8; 3. at least one of the adolescent mother's family members ("family member" is defined as a person she is biologically related to, or significant close others/partners with whom she is not biologically related) must be willing and available to participate in eight of the 10 video-based family therapy sessions; 4. fluency in english: the treatment will be carried out in english; and 5. consistent internet access (i.e., subscribe to an internet service provider and do not experience weekly disruptions in service) on a cell phone, tablet, or computer equipped with a camera and microphone. family exclusion criteria: adolescent mothers with 1. a current positive screen for problem alcohol use on the cage or tweak; 2. a current positive screen on the drug abuse items on the home visiting interview; 3. a current positive screen for domestic violence on the relationship assessment tool; 4. current hallucinations and/or delusions; 5. current homicidal ideation; 6. current suicidal ideation; 7. current severe major depressive episode as measured by the scid-v depression module for those over age 18, or nimh disc-y \& disc-p mood module for those under age 18; and/or 8. current self-injurious behavior (e.g., cutting arms on a weekly basis). families with 9. current child protection service involvement; 10. current family therapy service involvement; and/or 11. current or previous dialectical behavior therapy (dbt) treatment.
su011248 in the treatment of patients with bevacizumab (avastin)-refractory metastatic renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: the purpose of this study is to test whether sunitinib (su011248) has activity and is safe in patients with renal cell carcinoma (rcc) who have failed prior therapy with bevacizumab (avastin) -based treatment.


Eligibility criteria:
inclusion criteria: * histologically proven renal cell carcinoma of clear cell histology with metastases * evidence of measurable disease * radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment * prior radical or partial nephrectomy exclusion criteria: * prior treatment with any other anti-angiogenic therapy other than bevacizumab * prior systemic treatment for rcc \> 2 regimens * history of or known brain metastases * serious acute or chronic illness or recent history of significant cardiac abnormality
korean post marketing surveillance for elrexfio (elranatamab).

Conditions: Multiple Myeloma

Summary: this study is to assess the safety and effectiveness of elranatamab in the real-world clinical settings for the treatment of patients with multiple myeloma in korea.

this study is an open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of elranatamab in the real-world clinical setting in patients with multiple myeloma in korea. during the study period within 2 years from the launch date, a whole case enrollment should be conduct according to the protocol. the objectives of this study are to determine safety and effectiveness with elranatamab under conditions of general clinical practice, in compliance with the regulation of the mfds. therefore, this study was designed according to the pms guidelines of the mfds. the study population is patients who are eligible for "indications" specified in the approved label. all assessments described in this protocol are performed as part of normal clinical practice or standard practice guidelines for the patient population and healthcare provider specialty in the countries where this non-interventional study (nis) is being conducted.

Eligibility criteria:
inclusion criteria: * patients who have been prescribed elrexfio (elranatamab) by their physician as monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-cd38 monoclonal antibody, and have demonstrated disease progression on the last therapy. * patients with evidence of a personally signed and dated informed consent/assent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * patients with contraindication according to locally approved label of elrexfio (elranatamab) * any patients (or a legally acceptable representative) who does not agree that pfizer and companies working with pfizer use his/her information

Keywords: multiple myeloma elranatamab
a pharmacokinetic-pharmacodynamic dose comparison study of 8 mg/kg of inhaled or parenteral gentamicin in 12 mechanically ventilated critically ill patients treated for ventilator-associated pneumonia

Conditions: Ventilator-associated Pneumonia

Summary: ventilator associated pneumonia (vap) remains in the intensive care unit the infection associated with the highest morbidity and mortality. respiratory infection with resistant organism are increasing in prevalence. because of lack of alternatives, amino glycoside, old antibiotics family, can be used for several infection. aerosolized amikacin or tobramycin are used in mechanically ventilated patients for respiratory infections. gentamicin,which is effective against numerous multi drug resistant gram-negative organism and gram-positive like staphylococcus aureus, could be a great option for nebulisation. the investigators assume that nebulisation of gentamicin allows to obtain a higher lung concentration while assuring a systematic toxicity much lesser than a parenteral administration.


Eligibility criteria:
inclusion criteria: * to be in critical care unit * to be mechanically ventilated * to have a ventilator-associated pneumonia requiring a treatment by gentamicin * to be affiliated to a national insurance scheme * to have given an informed consent (patient or close person) exclusion criteria: * to be obese (bmi \> 40 kg/m²) * to have been treated by gentamicin for 7 days * to be allergic to aminoglycoside * to have a severe respiratory failure (pao2 / fio2 \< 150) * to have a renal failure (cl creat \< 60 ml/min/1.73m²) * to be under reinforced protection measure

Keywords: vap critical care pharmacokinetics gentamicin
effectiveness of cladribine tablets in participants with highly-active relapsing multiple sclerosis (camelot-ms)

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the main purpose of this study was to investigate the effectiveness of cladribine tablets in a uk real-world setting.


Eligibility criteria:
inclusion criteria: * physician diagnosis of hda-rrms as defined by clinical or radiological features * treatment initiation with cladribine tablet monotherapy on or after 22 august 2017 and at least 3 years before enrolment * completion of year 1 treatment of cladribine tablets (week 1 and week 2 treatment, per recommended dose in year 1: 1.75 milligrams per kilogram \[mg/kg\] body weight, cumulatively) exclusion criteria: * received cladribine tablet treatment within an interventional clinical trial during the study period * received treatment with any investigational therapy for rrms in the 6 months prior to cladribine tablet treatment initiation

Keywords: multiple sclerosis mavenclad ® cladribine
interactive tailored website to promote sun protection and skin self-check behaviors in patients with melanoma

Conditions: Stage 0 Skin Melanoma; Stage I Skin Melanoma; Stage IA Skin Melanoma; Stage IB Skin Melanoma; Stage II Skin Melanoma; Stage IIA Skin Melanoma; Stage IIB Skin Melanoma; Stage IIC Skin Melanoma; Stage III Skin Melanoma; Stage IIIA Skin Melanoma; Stage IIIB Skin Melanoma; Stage IIIC Skin Melanoma

Summary: this clinical trial studies how well an interactive tailored website works in promoting sun protection and skin self-check behaviors in patients with stage 0-iii melanoma. an internet-based program may help individuals to perform skin self-checks and engage in sun protection behaviors.

primary objectives: i. to evaluate the impact of the interactive tailored website (itw) versus usual care on skin self-examination (sse) and sun protection behaviors among individuals diagnosed with melanoma. secondary objectives: i. to examine mediators of the impact of the intervention. the effects of the intervention on sse and sun protection behaviors will be mediated by melanoma knowledge, self-efficacy for sse and sun protection behaviors, perceived benefits of sse and sun protection behaviors, perceived barriers to sse and sun protection behaviors, and perceived controllability of melanoma. tertiary objectives: i. to examine moderators of the impact of the intervention. to evaluate whether itw effects are moderated by the following factors: time since diagnosis, disease stage, age, sex, income, education, internet experience, distress about melanoma, worry about recurrence, and evaluation and usage of the itw. outline: phase i: patients review draft website content materials in a semi-structured format and provide feedback via open- and closed-ended questions for the development, testing, and finalization of itw. phase ii: patients are randomized into 1 of 2 arms. arm i: patients access itw and complete each module over 30-40 minutes. arm ii: patients receive usual care and are then offered itw. all patients in phase ii complete surveys over 20-40 minutes at 8, 24, and 48 weeks.

Eligibility criteria:
inclusion criteria: * phase i: diagnosis of primary pathologic stage 0-iii cutaneous malignant melanoma * phase i: from 3-36 months post-surgical treatment * phase i: access to the internet * phase i: able to speak and read english * phase i: able to provide informed consent * phase ii: diagnosis of primary pathologic stage 0-iii cutaneous malignant melanoma * phase ii: from 3-24 months post-surgical treatment * phase ii: not adherent to thorough sse (i.e., did not check every area of the body at least once during the past 2 months) * phase ii: not adherent to sun protection recommendations (i.e., mean score \< 4 \[which corresponds to "often"\] on a 5-point scale \[from 1 = "never" to 5 = "always"\] that assesses the frequency of engaging in four sun protection behaviors) * phase ii: access to a computer connected to the internet * phase ii: able to speak and read english * phase ii: able to provide informed consent
cisplatin chemoradiation with or without cetuximab for locoregionally advanced squamous cell carcinomas (scc) of the head and neck

Conditions: Head and Neck Neoplasms; AJCC Stage III/IV

Summary: to examine the safety and toxicity of concurrent radiotherapy with cisplatin with the further addition of cetuximab experimental treatment

conventional radiotherapy (65-70 gy, 1.8 gy per day) concurrently with weekly cisplatin (40mg/m2) (group a, n=25) or with weekly cisplatin (40mg/m2) and weekly cetuximab 250mg/m2, after initial dose of 400mg/m2) (group b, n=25) is applied (in a 1:1 randomization ratio). groups will be matched age, sex, ps, and disease site.

Eligibility criteria:
inclusion criteria: * histologically confirmed hnscc of oral cavity, larynx, oropharynx or * hypopharynx; age of 18 years or more * adequate liver (sgot, sgpt, alp ≤ 3x normal) * kidneys (creatinine clearance ≥ 60ml/min * heart (no arrythmias, no heart failure) and * bone marrow (wbc ≥ 4,000/μl, granulocytes ≥ 1,500/μl, hb ≥ 10g/dl, platelets ≥ 100,000/μl) function * ecog performance status 0 or 1 and * stage iii or iva to b with measurable lesions * written informed consent exclusion criteria: * prior radiotherapy * chemotherapy * concurrent active malignancies * pregnancy * breast-feeding

Keywords: locally advanced, unresectable, head and neck squamous cell carcinoma, stage iii/iv
mechanisms involved in the developement of sports addiction among military personnel

Conditions: Addiction

Summary: sport addiction (or exercise addiction) has been recognized as a pathology by the world health organization since 2011. however, it is still relatively under-researched. it is one of the so-called behavioral addictions and has long-term negative consequences for physical, psychological and social health, such as : isolation ; frequent injuries; co-addiction with or as a result of sports'. the study is aimed in particular at military physicians and will target a population where sport is an integral part of the job and where sporting performance is valued: military personnel. the aim of this study is to explain and try to understand this pathology through the experiences of those who suffer from it. therefore, investigators have chosen to conduct a qualitative study inspired by the embedded theory. semi-structured individual interviews will be conducted using an interview guide. this guide, consisting of 5 or 6 open-ended questions, will help to set the general direction of the interview without preventing the participant from deviating. the interview guide may evolve as the interviews progress, enriched by any new ideas or themes that emerge.


Eligibility criteria:
inclusion criteria: * serving or reservist military personnel * perceive themselves as "addicted to sport" and say so exclusion criteria: * minor * incapable major * patient unaware of diagnosis * pregnant woman * legionnaire not rectified

Keywords: sports addiction military comprehension model
efficacy of apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis

Conditions: Myasthenia Gravis; Ocular Myasthenia Gravis

Summary: this study is aimed at assessing the efficacy of apraclonidine eye drops in the treatment of ptosis secondary to myasthenia gravis.

the rationale behind using apraclonidine is that it acts on muller's muscle which is a sympathetic-innervated muscle. as such, this muscle is expected to be spared from the effects of the autoantibodies that attack the postsynaptic portion of the neuromuscular junction in myasthenia gravis.

Eligibility criteria:
inclusion criteria: * patients aged 18 or older with a diagnosis of ocular or generalized myasthenia gravis with ocular involvement. exclusion criteria: * patients receiving mono-amino-oxidase inhibitors. * patients with history of hypertension, cardiac, or cerebrovascular disease. * women with confirmed pregnancy.

Keywords: myasthenia gravis ocular myasthenia apraclonidine
ript of ibuprofen topical gel

Conditions: Pain

Summary: this study is being conducted to determine the potential of ibuprofen 5% topical gel and its vehicle gel to cause sensitization after repeated topical application to healthy skin of human subjects under controlled conditions.


Eligibility criteria:
inclusion criteria: healthy male or female subjects 18 years of age or older, female subjects of childbearing potential and males are using an acceptable form of birth control, subjects are free of any systemic or dermatologic disorder exclusion criteria: have any visible skin disease at the application site, not willing to stop use of systemic or topical analgesics, corticosteroids, or antihistamines, not willing to stop use of sunscreens, creams, or similar products on the back during the study

Keywords: repeat insult patch test
a pilot stress management intervention study for high risk children with asthma

Conditions: Asthma

Summary: the purpose of the proposed study is to conduct a randomized controlled pilot trial of a school-based stress management and coping skills training program among a sample of economically disadvantaged urban 8- to 12-year-old school children with physician-confirmed asthma. the investigators aim (1) to establish feasibility of this approach by recruiting from different schools and (2) to learn whether individuals assigned to receive the intervention show improvements in psychological function, decreases in lung inflammation, and related improvements in asthma health when compared with disease severity-matched peers who receive education-only or standard care.


Eligibility criteria:
inclusion criteria: * in grades 3 through 8 and attending one of the 11 participating public schools * age 8 through 14 years * qualify for the free or reduced cost school lunch program in pennsylvania (families that receive food stamps or have an annual income of \< $40,900). * meets national heart lung and blood institute (nhlbi, 2007) criteria for any asthma diagnosis except mild, intermittent asthma, as confirmed by the study physician using nhlbi guidelines for the diagnosis and management of asthma (http://www.nhlbi.nih.gov/guidelines/asthma/asthsumm.pdf, page 40). * has a parent or legal guardian who is willing to participate in the study * fluent in english (i.e., have commonly used english in everyday speaking and reading for at least 10 years) exclusion criteria: * history of a chronic illness in addition to asthma (determined by parent or guardian report) * prescribed medications other than for asthma * mental retardation or significant developmental delay * inability to speak or understand english * a diagnosis of mild, intermittent asthma as determined using nhlbi (2007) criteria (see above) * age less then 8 years or greater than 14 years * not in grades 3 through 8 * not qualifying for free or reduced cost school lunches in pennsylvania * no parent or legal guardian who is willing to participate

Keywords: asthma stress children psychosocial factors relaxation stress management
efficacy of intra-articular neostigmine versus ketamine for postoperative analgesia in arthroscopic knee surgery

Conditions: Postoperative Pain

Summary: to compare the efficacy of intra-articular administration of neostigmine versus ketamine as adjuvant analgesics after knee arthroscopy.

arthroscopic knee surgery is commonly performed as an outpatient procedure and is often associated with postoperative pain. intraarticular (ia) local anesthetics (la) are often used for prevention of pain after arthroscopic knee surgery; however, the degree of postoperative pain varies. in an effort to find the ideal regime for sufficient, long-lasting postoperative analgesia, many different drugs, including opioids, nonsteroidal anti-inflammatory drugs, ketamine, clonidine, and neostigmine, have been added to the ia las the investigators designed this study to compare the efficacy of intra-articular administration of neostigmine versus ketamine as adjuvant analgesics after knee arthroscopy.

Eligibility criteria:
inclusion criteria: * one hundred patients aged above 18-50 years (asa i or ii) scheduled for elective arthroscopic knee surgery under intrathecal anaesthesia will be enrolled in our study. exclusion criteria: * absolute or relative contraindications for intrathecal anaesthesia, * allergy for the studied drugs. * patients having history of cardiovascular, cerebrovascular, and respiratory diseases, * patients receiving chronic pain treatment or hypertension treated with α methyldopa, clonidine or β adrenergic blockers were excluded from the study.
reversal of hypoglycemia unawareness using continuous glucose monitoring

Conditions: Diabetes Mellitus

Summary: the purpose of doing this study is to see if continuous glucose monitoring can help people with type 1 diabetes who are sometimes unable to feel if they have a low blood glucose reading. for this study we will be using the navigator continuous glucose monitor. we think that your body may not have enough of a certain hormone that usually helps people know when they are going low. if you can keep from going low, we think there will be enough of that hormone to help you recognize the symptoms of a low before it happens.

to enroll in this study you must be between the ages of 7 and 20, have type 1 diabetes, and experience at least two episodes of low blood glucose readings weekly that you do not feel. up to 25 subjects will be enrolled at stanford and another 25 at the barbara davis center in colorado. the study will last approximately 8 months for each participant.

Eligibility criteria:
inclusion criteria: 1. be at least 7 to 20 years old 2. have been diagnosed with type 1 diabetes for at least 1 year 3. report 2 or more episodes per week of asymptomatic hypoglycemia as determined by completion of the hypoglycemia awareness questionnaire (haq) or as determined by investigator 4. hba1c level \< 10% 5. internet access for downloading continuous glucose monitoring (cgm), access to a compatible computer (windows vista is not compatible for downloading.) 6. for females, you are not intending to become pregnant during the study 7. no expectation that you will be moving out of the area for the duration of the study exclusion criteria: 1. the presence of a significant medical disorder (including epilepsy, or any cause of seizures other than hypoglycemia) that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol 2. treatment with systemic or inhaled corticosteroids in the last six months 3. inpatient psychiatric treatment in the past six months for you or your primary caregiver 4. current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study 5. having two or more severe hypoglycemia episodes (seizure or loss of consciousness) in the six months prior to enrollment 6. having a severe hypoglycemic episode in the 30 days prior to enrollment