Kornimate/medical-research-clean huggingface dataset:
parents matter!: interventions to promote effective parent-child communication

Conditions: HIV Infections; Sexually Transmitted Diseases; Pregnancy

Summary: parents matter is a community-based project whose goal it is to develop and test an intervention designed to promote effective parent-child communication about sexuality in order to promote sexual health among adolescents.

participants in the intervention are african american parents or guardians who have children in the 4th or 5th grade that are 12 or younger. recruitment was done through schools, housing authorities, community based organizations, and churches. participants were randomly assigned to participate in one of three interventions delivered by community based interventionists. the enhanced sexuality communication intervention consists of five 2.5 hour sessions conducted over 5 weeks with booster sessions at 12 and 24 months post-intervention. the full sexual communication intervention focuses on general parenting skills and sexual communication skills using a variety of presentation modalities: group discussion, video, and role-plays. the brief sexual communication intervention consists of a single 2.5 hour session in which parents are provided with information on general parenting skills and sexual communication skills. thus, this intervention seeks to provide the same information as the full sexual communication intervention but in a condensed format with little group participation. the control intervention is a single 2.5 hour session focusing on general child health issues such as diet and exercise rather than parenting and sexual communication.

Eligibility criteria:
inclusion criteria: the eligibility criteria for the parent-child dyad are as follows: * the parent or guardian must be african-american * the parent or guardian must be the primary caregiver for a child in 4th or 5th grade who is 12 or younger at the time of the 1st assessment. * the parent or guardian and the child must have lived together continuously for at least the past 3 years and the child must spend most nights (5 or more) with the parent or guardian. * the parent or guardian and the child must both speak english.

Keywords: parent-child communication primary prevention sexual risk prevention hiv
haic combined with toripalimab and donafenib for advanced btc

Conditions: Biliary Tract Adenocarcinoma

Summary: this is a single center, single arm, phase ii, prospective study to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (haic) combined with pd-1 inhibitor immunotherapy toripalimab and tyrosine kinase inhibitor donafenib in patients with advanced biliary tract cancer.


Eligibility criteria:
inclusion criteria: * 18 to 80 years of age, of any sex; * histologically/cytologically confirmed diagnosis of unresectable advanced adenocarcinoma of the gallbladder, intrahepatic bile duct and extrahepatic bile duct. * at least one measurable lesion umder ct/mri as defined by recist1.1 criteria * patients must have adequate organ and marrow function as defined below: blood test: hemoglobin (hb) ≥90 g/l absolute neutrophil count (anc) ≥1.5×10\^9/l； platelet (plt) ≥80×10\^9/l； biochemical test: total bilirubin≤2×uln (institutional upper limit of norm) ast(sgot)/alt(sgpt)≤2.5 ×uln creatinine clearance≥ 50 ml/min as calculated by the cockroft-gault formula * eastern cooperative oncology group (ecog) performance status (ps) score of 0-1; * indocyanine green retention rates at 15 min (icgr15\<22%; * life expectancy of \> 3 months; exclusion criteria * patients with other malignant tumors should be excluded * female patients who are pregnant or breast-feeding. female patients who are pregnant during the study should also exit. * patient has enter any other clinical trails within 4 weeks prior to study entry. * patient known with a severe and/or uncontrolled medical disease. * chronic non-healing wound/bone fracture * history of organ transplant * patients with abnormal coagulation function (pt\>16s, aptt\>43s, tt\>21s, fbg\<2g/l), those have bleeding tendency (14 days prior to randomization must meet: inr is within the normal range without any use of anticoagulants); patients treated with anticoagulants or vitamin k antagonists such as warfarin, heparin or analogous therapy; use for preventive purposes is permitted provided that the international normalized ratio of prothrombin time (inr) ≤ 1.5, take low-dose warfarin (1 mg po, qd) or low-dose aspirin (do not exceed 100 mg per day); * previous history of aterial/venous thrombosis such as cerebrovascular accidents, pulmonary embolism or deep venous thrombosis within one year prior to patients recruitment. * hitstory of psychiatric drug abuse and hasn't come clean, or with psychiatric illness/social situations that would limit compliance with study requirements * history of immunodeficiency, or other acquired/congenital immunodeficiency diseases * concomitant diseases that severely endanger the safety of the subject or affect the study completion according to the judgment of the investigator * willingness to sign a written informed consent document, with good compliance.
montmorency cherry supplementation, sleep, and inflammation

Conditions: Insomnia Chronic; Inflammation

Summary: this study will test the effects of montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of ≥ 25.0 kg/m2; * sleep issues as identified by a global score of 5 or greater on the pittsburgh sleep quality index (psqi) and/or a score 8 or higher on the insomnia severity index (isi); * ability to adhere to a diet low in antioxidants during the study period; and * willingness to wear a fitbit for the duration of the study and to wear the zmachine on selected nights. exclusion criteria: * unwilling or unable to stop the use of sleep medication * unable to attend laboratory visits on the east lansing, michigan campus
belatacept and risk of post-transplant lymphoproliferative disorder in us renal transplant recipients

Conditions: Kidney Transplantation; Transplantation, Kidney

Summary: * to estimate the incidence rates of post-transplant lymphoproliferative disorder (ptld) in adult, ebv seropositive, kidney alone transplant recipients treated with belatacept at the time of transplantation * to estimate the incidence rates of ptld in adult, ebv seropositive, kidney alone transplant recipients treated with calcineurin inhibitors (cni)-based regimens at the time of transplantation * to compare the ptld incidence rates in adult, ebv seropositive, kidney alone transplant recipients treated with belatacept to the rates in adult, ebv seropositive, kidney alone transplant recipients treated with cni-based regimens at the time of transplantation


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * adult, * ebv seropositive, kidney only transplant recipients initiated on belatacept and adult, * ebv seropositive, kidney only transplant recipients initiated on cnis reported to the united network for organ sharing (unos) during the period of recruiting belatacept users
acupuncture combined with yanqing zhitong ointment acupoint application in chronic non-specific low back pain

Conditions: Non-specific Low Back Pain

Summary: carry out a randomized controlled double-blind study, the acupuncture combined with placebo application group was compared with the acupuncture combined with yanqing zhitong ointment acupoint application group, 86 patients with chronic non-specific low back pain were included.

treatment group(acupuncture combined with yanqing zhitong ointment acupoint sticking) acupoints for manual acupuncture:weizhong(bl40), shenshu(bl23) ,dachangshu(bl25) ,geshu(bl17) ,kunlun(bl60) ,ashi point acupoints for sticking:according to the location of pain, we select acupuncture points along the meridian controal group(acupuncture combined with placebo application) interventions are same as treatment group. both groups were treated 3 times a week for 4 weeks.

Eligibility criteria:
inclusion criteria: 1. diagnostic of non-specific low back pain 2. aage from 18 to 65 3. last for at least 12 weeks 4. vas between 4 and 7 5. no other treatment in the past 3 months 6. patients with no partial skin damage 7. no other relevant treatment methods 8. sign informed consent and informed consent exclusion criteria: 1. pregnant women 2. suffer from diabetes 3. with skin ulcers or contusion wounds 4. past history of severe allergy to transdermal preparations 5. complicated with serious diseases
pappalysin 2 (papp-a2) enzyme replacement

Conditions: Short Stature, Idiopathic

Summary: this study evaluates the transfusion of fresh frozen plasma containing the enzyme papp-a2 into the a female adult. this female adult has a mutated version of papp-a2 that prevents the unbinding of igf-1 from igf binding proteins. the investigator's hypothesize that transfusion of plasma with donor papp-a2 will lead to the unbinding of igf-1 from its binding proteins and that they will be able to measure free igf-1 in the blood of this female adult.

papp-a2 is a plasma protease that is known to cleave igfbp-3 and igfbp-5. it is thought that this cleavage frees up igf-1 from its bound form allowing it to become the active free igf-1. the participant has short stature accompanied with elevated plasma levels of both igf-1 and igf binding protein 3 (igfbp-3). genetic analysis of the participant identified a novel missense mutation in pappa2 (ala1033val). this gene is a perfect candidate to explain our patients' phenotype. the investigators' hypothesis is that loss of activity of papp-a2 leads to an inability to cleave the igf binding proteins and thus an overall elevation in igfbp-3 and consequent elevation in total igf-1. however, this igf-1 cannot be freed up and is thus not able to be active leading to short stature. the patient's missense variant is predicted to be damaging by in silicon prediction models such as polyphen2. furthermore, two knock out mouse models of pappa2 as well as a zebrafish knock out exist, all showing growth retardation (post-natally in the mice). taken together, this is definitive evidence that the patients' mutation in pappa2 is responsible for their short stature phenotype.

Eligibility criteria:
inclusion criteria: * homozygous for a defect in pappa2. exclusion criteria: none
cold water immersion stirring in hyperthermic individuals

Conditions: Hyperthermia

Summary: the best way to cool a very hot person is using cold water immersion, however, the optimization of this technique has not been established. the goal of this study is to determine differences in cooling rates among two types of cold water immersion and passive cooling following immersion.


Eligibility criteria:
inclusion criteria: * 18-39 y old men and women * self-reported to be healthy * currently completes aerobic exercise at least 30 minutes a day, at least 2 days per week exclusion criteria: * history of any cardiovascular, neurologic, renal, or metabolic disease * history of any contraindications on the coretemp contraindications and warnings document * current tobacco use or regular use within the last 2 years * taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.) * history of exertional heat stroke * currently pregnant or breastfeeding * inability to follow the rules of the protocols or understand the consent form
wether vns in early stage (3 months) is safe and more beneficial for post-stroke motor rehabilitation

Conditions: Stroke; Motor Rehabilitation

Summary: upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts. in previous study, vagus nerve stimulation was constricted to patients 9 months after stroke. in this randomized phase i trial, we would apply vagus nerve stimulation in an early stage (\<6 month) and observe its theraputic effect on motor function after ischaemic stroke.we hypothesized that the early stimulation could be safe and more beneficial compared to stimulation in late stage.


Eligibility criteria:
inclusion criteria: * eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 3-36 months before surgery. * individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an fm-ue score of ≤42 * sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the fm-ue elbow flexion, elbow extension or finger mass flexion or extension). exclusion criteria: * excessive spasticity or contracture of the upper-extremity muscles (that is, modified ashworth scale = 4) . severe cognitive impairment (mini mental state examination \< 24)

Keywords: hemiparesis vns limb motor function rehabilitation
a multicenter, 4-week crossover (total duration 12 weeks) to determine the impact of qva149 on nocturnal oxygen levels in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study was to determine whether a fixed dose combination of indacaterol and glycopyrronium (qva149) has an impact on night-time blood oxygen levels in chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of copd (according to gold guidelines, updated 2014) with a post-bronchodilator fev1/fvc \<0.70 * patients with a post-bronchodilator fev1 ≥30% and \<60% of the predicted normal value * resting daytime oxygen saturation levels measured by pulse oximetry of ≤95% spo2 * smoking history of at least 10 pack years (ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years) exclusion criteria: * an exacerbation of copd (treatment with oral or parenteral antibiotics and/or glucocorticosteroids and/or hospitalization related to copd) within 4 weeks prior to screening or during the run-in period * diagnosed asthma * patients receiving regular long term oxygen therapy (ltot) * ongoing / planned rehabilitation during the study period * three or more awakenings during the night leading to toilet visit or other reasons for exiting the bed during the last week prior to the screening visit due to non-copd reasons other protocol-defined inclusion/exclusion criteria may apply.

Keywords: copd qva149 nocturnal oxygen levels combination bronchodilator
study to evaluate clinical efficacy and safety of "medifoam h" in wound healing

Conditions: Trauma

Summary: the wound healing efficacy and safety of "medifoam h" in patients with minor, acute trauma. the hypothesis of this study is that using "medifoam h" dressing for a week is not inferior to using "duoderm thin" dressing in wound healing.

this study is single-center, randomized, active-controlled, open-label, phase iv to evaluate clinical efficacy of wound healing and safety of "medifoam h" in patients with minor, acute trauma. 33 patients of treatment group and 33 patients of control group, total 66 patients will be enrolled to this study. every patient will be treated with "medifoam h" or "duoderm thin" for a week. during their participation, patients will visit 2 days and a week after to see investigator. investigator will observe the wound and evaluate amount of exudation, infection status, wound healing.

Eligibility criteria:
inclusion criteria: 1. who has acute trauma(laceration, abrasion, stitched wound, under superficial second-degree burn etc.)who satisfies at least 1 condition between followings: 1. laceration, stitched wound: length of under 10cm. 2. abrasion, burn: total area of under 100㎠ , depth of under 2mm. 2. agreed to participate voluntarily in the study exclusion criteria: 1. who has hypersensitivity to hydrocolloid or its history. 2. deep or severe infectious diseases of skin(example: phlegmon, abscess, ulcer, boil etc..) which is hard to treat with this investigational product. 3. a wound which is bitten by animal, human or inject. or a wound has possibility of secondary infection through the tresis. 4. who need surgical intervention for infection treatment. 5. who has bacterial, viral, animal infectious disease 6. who judged inappropriate to participate in the study by investigator.

Keywords: wound healing hydrocolloid wound dressing medifoam h duoderm thin mild acute trauma
safety study of using stem cells to stimulate development of new blood vessels in peripheral vascular disease

Conditions: Peripheral Vascular Diseases

Summary: the purpose of this study is to determine if bone marrow derived adult stem cells are safe and effective in inducing development of new blood vessels (angiogenesis) in the legs of patients with severe peripheral vascular disease.

presently there are no effective medical therapies to enhance blood flow in the legs of patients with peripheral vascular disease. for patients with limb threatening ischemia the only option for relief of rest pain or gangrene is amputation. there is evidence in animal and clinical studies that adult stem cells in the bone marrow, called endothelial progenitor cells, participate in the development of new blood vessels, a process called angiogenesis. in this investigation, patients with limb threatening ischemia will have their bone marrow harvested and the stem cells will then be removed and injected directly into the muscle of the diseased leg. the procedure will require about 4 hours and the subjects will be admitted to the indiana university medical center overnight. the follow-up period is 12 weeks and the analysis will consist of examinations at 1, 2, 4, 6, 8, and 12 weeks. adverse and serious adverse events will be recorded during this time period. diagnostic studies will be obtained to measure blood flow in the treated leg during the follow up period and include transcutaneous (skin) oxygen measurements, pressure recordings in the leg, arteriography, magnetic resonance imaging, and wound healing.

Eligibility criteria:
inclusion criteria: * severe peripheral vascular disease not amenable to bypass or angioplasty * age \>21 years old * normal renal function (creatinine \< 1.6) exclusion criteria: * congestive heart failure (ejection fraction \[ef\]\<30%) * history of cancer or myeloproliferative disorders * proliferative retinopathy * pregnancy * cognitively disabled
secukinumab efficacy without the initial loading dose in patients with psoriasis

Conditions: Psoriasis Vulgaris

Summary: this was a retrospective, observational study. the objective of the study is investigate the efficacy and safety of secukinumab without the initial weekly loading dose in patients with chronic plaque psoriasis. patients were stratified in two groups, those receiving secukinumab at the dose 300 mg every 4 weeks from the beginning (cases) and those who received the initial label, weekly loading dose (controls). efficacy was evaluated by comparing the proportion of patients achieving pasi75 responses at week 16, 32 and 48 between cases and controls. safety was evaluated by reporting every adverse events up to week 48.


Eligibility criteria:
inclusion criteria: * patients older than 18 years old * patients with moderate to severe chronic plaque psoriasis treated with secukinumab with or without initial loading dose for at least 48 week * the criteria for receiving secukinumab were according to standard clinical practice. exclusion criteria: * patients younger than 18 years old * patients with only psoriatic arthritis or with other forms of psoriasis than chronic plaque type (such as drug-induced psoriasis or guttate, erythrodermic, or pustular psoriasis) * pregnant women and women during breastfeeding

Keywords: secukinumab loading dose chronic plaque psoriasis no loading dose
visceral osteopathic manual therapy methods in women with stress urinary incontinence

Conditions: Osteopathic Manipulative Treatment (OMT)

Summary: the aim of this study is to evaluate the effect of visceral osteopathic manual therapy method for stress urinary incontinence in female patients. as a result of the study, the effect of visceral osteopathic manual therapy fascial release on bladder control, quality of life and flexibility will be evaluated.

urinary incontinence (ui) is an important health problem that occurs when continence cannot be achieved and negatively affects the lives of individuals according to the international continence society (ics). stress urinary incontinence (sui), one of the most common types of ui, is a problem that occurs during coughing, laughing, sneezing, exercise (one of which is caused by increased intra-abdominal pressure (valsalva maneuver) and shows a steady increase in women with age. the aim in the treatment of sui is to ensure that patients regain their continence skills. in recent years, conservative treatment methods have been preferred more in the treatment of sui due to their ease of application and low cost. it is thought that osteopathic manual therapy (omt) reduces the negative effects of musculoskeletal pain and dysfunction on body systems, improves respiratory mechanics, venous and lymphatic drainage, and accordingly supports homeostasis and optimizes functions. in this study, it is planned to investigate the effect of the visceral system and visceral fascia on sui. it is thought that the fascia surrounding the internal organs can be loosened and systematic diseases can be affected with the visceral osteopathic manual therapy (vomt) method, which is among the osteopathic manual therapy methods. within the scope of the study, 40 volunteer female patients diagnosed with sui will be evaluated and randomly divided into 2 groups. day 1 evaluation scales will be applied to both groups, vomt methods will be applied to the experimental group a total of four times a week, and bladder mobilization will be given as a home program, and no application will be made to the control group. both groups will be re-evaluated in months 1 and 4. the inadequacy of studies conducted on this subject was an important factor in choosing this method.

Eligibility criteria:
inclusion criteria: * being a woman between the ages of 18 and 70 * being able to communicate in turkish * being able to read and write * being able to understand and follow verbal prompts * being willing to participate in the study exclusion criteria: * pregnancy * presence of prolapse * presence of vaginal and urinary system infection or malignancy * presence of neurological damage * having had any disease that may cause incontinence * having had surgery for sui or urogynecological reasons in the last 2 months.

Keywords: urinary stress incontinence osteopathic manipulative treatment (omt) quality of life