Kornimate/medical-research-clean huggingface dataset:
a trial of placebo versus enzastaurin for lung cancer prevention in former smokers

Conditions: Lung Cancer

Summary: to compare the difference of a marker of cellular proliferation in all bronchial biopsy specimens of former smokers stratified by lung cancer risk, collected before and after treatment per patient between the enzastaurin and placebo groups.


Eligibility criteria:
inclusion criteria: * sputum atypia participants with normal sputum cytology will be removed from the study) * metaplasia or dysplasia on at least one bronchoscopy specimen * history of cigarette smoking ≥30 pack years * quit smoking ≥1 year prior to study entry * able to undergo bronchoscopy and helical computed tomography (ct) scanning of the chest * able to swallow tablets exclusion criteria: * blood clotting abnormalities * current smoking within the past 1 year * unwillingness to abstain from smoking while enrolled in the clinical trial or unwillingness to avoid significant second hand smoke exposure * evidence for lung cancer or carcinoma in situ * active cardiovascular disease * current illicit drug or alcohol abuse

Keywords: healthy prevention
case series of weekly applications of dhacm in treatment of pressure ulcers

Conditions: Pressure Ulcer

Summary: a prospective case series investigating the efficacy and safety of dehydrated human amnion/chorion membrane (dhacm) in the treatment of patients with stage ii or iii pressure ulcers


Eligibility criteria:
inclusion criteria: 1. index ulcer characteristics: 1. ulcer present for ≥ 30 days (day 0) 2. index ulcer is located spine, lower back or buttocks 3. index ulcer area after debridement is ≥ 2 cm² and ≤ 25 cm² at the randomization visit 4. ulcer must be stage ii or iii as determined by the national pressure ulcer advisory panel (npuap) pressure ulcer staging system 2. subject criteria must include: 1. age 16 or older 2. the subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study (minors will provide assent with consent provided by parent) exclusion criteria: 1. index ulcer characteristics that will make subject ineligible for enrollment: 1. stage i or iv ulcers as determined by npuap pressure ulcer staging system 2. signs and symptoms of local infection 3. previous surgical procedure performed at site 4. known or suspected local skin malignancy at index ulcer site 5. prior radiation therapy treatment at the index ulcer site 2. subject criteria that will make subject ineligible for enrollment: 1. presence of other diseases which, in the opinion of the investigator, may result in allograft failure or has experienced graft failure in the past (examples include: immune system disorders including systemic lupus erythematosus (sle), fibromyalgia, acquired immunodeficiency syndrome (aids) or hiv) 2. currently taking medications which in the opinion of the investigator may affect graft incorporation 3. allergy or known sensitivity to aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate 4. any condition(s) that in the opinion of the investigator may seriously compromises the subject's ability to participate in this study. examples include: known history of poor adherence with medical treatment, current drug or alcohol abuse or a medical/psychiatric condition 5. pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study or are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence) 6. subjects currently enrolled in this study (i.e. concurrent enrollment in the study is prohibited) 7. subject has used any investigational drug(s) or therapeutic device(s) within 30 days preceding screening. 8. any pathology that would limit the blood supply and compromise healing 9. subject is a prisoner
circulating tumor dna in patients diagnosed with lung metastasis from colorectal cancer: candidate selection for local ablative therapy

Conditions: Colorectal Cancer; Lung Metastases

Summary: the investigators will detect circulating tumor dna in blood of patients with lung metastases from colorectal cancer using ngs technology and intend to use it for predicting the outcome of local treatment (surgery or radiation) and recurrence of lung metastases.

the investigators produce customized gene target panel by selecting genes that are commonly found in colorectal cancer and metastasis from existing literature. in patients diagnosed with lung metastases from colorectal cancer, 20ml of whole blood is collected before and after local treatment (surgery or radiation) and cell-free dna (cfdna) is extracted from the collected blood. thereafter, 20 ml of whole blood is additionally collected once after 3 months (±2 months) and once after 6 months (±2 months) during follow-up and cfdna is extracted. the investigators perform sequencing from the extracted cfdna. the investigators compare the mutations detected in cfdna before and after local treatment and identify the trend of reducing mutations in cfdna after local treatment. so the investigators discover biomarkers for the outcome of local treatment. the investigators also search for mutations for target drugs from mutation profiling of cfdna.

Eligibility criteria:
inclusion criteria: 1. adults over 19 years of age 2. those who understand research and have written consent 3. cases diagnosed with lung metastases from colorectal cancer exclusion criteria: 1. pregnant women, nursing women 2. those who lack the ability to voluntarily agree 3. participation in other clinical trials where drugs for clinical trials are administered within the past four weeks as of the date of participation in clinical trials
daily disposable contact lens tear film study

Conditions: Myopia

Summary: the purpose of this study was to evaluate the pre-lens tear film stability of a new ce-marked daily disposable contact lens as compared to a commercially available daily disposable contact lens.


Eligibility criteria:
inclusion criteria: * be of legal age of consent and sign informed consent document. * willing and able to wear spherical contact lenses for 16 hours. * willing and able to wear spherical contact lenses within the available range of powers. * best corrected spectacle visual acuity equal or better than 20/25 or 6/7.5. * other protocol-defined inclusion criteria may apply. exclusion criteria: * anterior segment infection, inflammation, or abnormality. * any use of systemic medications for which contact lens wear could be contraindicated. * history of refractive surgery or irregular cornea. * currently enrolled in any clinical trial. * eye injury within twelve weeks prior to enrollment. * other protocol-defined exclusion criteria may apply.
livia 2.0 : a rct of two french internet intervention for adults struggling with prolonged grief symptoms

Conditions: Prolonged Grief Disorder

Summary: the investigators aim to compare the efficacy of an ibi targeting complicated grief symptoms (livia 2.0) compared to an already investigated ibi (livia 1) using a guidance on demand design in a randomised controlled trial (rct). more specifically, the investigators will test the following primary hypotheses: * both interventions will significantly increase participants' well-being and decrease their distress, and those changes will be stable until follow-up. * livia 2.0 will be more efficient than livia 1 on all measure outcomes. * livia 2.0 will have less dropouts than livia 1.

secondary objectives are the following: * participants of livia 2.0 will require less guidance (number of people requesting support and number of e-mails exchanged) than participants in livia 1. the investigators will also explore which session triggers more requests of guidance. * using a monitoring of participants' state throughout the completion of the programme in livia 2.0, the investigators will explore the short-term efficacy of each module on participants' weekly mood, solitude feelings and grief symptoms. * the investigators will compare participants' satisfaction in both versions of livia. * the investigators will also explore the role of attachment style, type of loss, relationship quality with the partner, the interpersonal closeness with the lost person, symptom severity and level of solitude at onset as moderators of the efficacy of the programmes. * the investigators will explore the semantic content of the exercises included in the programme to see if this is related with the improvement over the assessment period.

Eligibility criteria:
inclusion criteria: * bereavement or separation/divorce * either of these events should have happened more than 6 months before participating in the study * feeling the need for support to cope with the loss (a diagnosis of complicated grief is not necessary) * age: 18 years or older * regular internet access * mastery of the french language - approved icf exclusion criteria: * moderate to acute current suicidality (sidas \> 19) * severe psychological or somatic disorders which need immediate treatment. * concomitant psychotherapy * prescription or change in dosage of psychoactive drugs in the month prior or during the self-help intervention. * inability to follow the procedures of the study, e.g. due to comprehension problems * enrolment of the investigator, his/her family members, employees, and other dependent persons.
the influence of local infiltration analgesia by catheter in postoperative control pain after total hip replacement

Conditions: Musculoskeletal Pain; Hip Injuries

Summary: a randomized double-blind clinical trial was performed. there were 4 groups according to catheter placement and infusion constituents: 1) intraarticular catheter + anesthetics; 2) intraarticular catheter +placebo; 3) subfascial catheter + anesthetics; 4) subfascial catheter + placebo. the anesthetics infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). the placebo solution consisted in physiological serum (bolus + continuous perfusion up to 36 hours). randomization was performed in the hospital pharmacy and the surgeon kept out the surgical field when the resident placed the catheter. the same conventional analgesic schedule was prescribed to all patients: pca (patient controlled analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. the pain was evaluated by means of pca (patient controlled analgesia) shots and the vas (visual analog scale). side effects, time to start rehabilitation and time to discharge were also analyzed. a statistical analysis was performed to compare all this variables between the 4 groups (spss 18.0).


Eligibility criteria:
inclusion criteria: * primary total hip replacement exclusion criteria: * allergic to bupivacaine
neural tensioner exercise on conditioned pain modulation

Conditions: Neck Pain; Diffuse Noxious Inhibitory Control

Summary: background: there is evidence linking conditioned pain modulation (cpm) deficiency with musculoskeletal pain syndromes such as fibromyalgia, migraine, tension-type headaches and irritable bowel syndrome, as well as with temporomandibular disorders, idiopathic facial pain and chronic fatigue syndrome. evidence shows that in pre-surgical situations of chronic pain there is no activation of cpm. objectives: the purpose of this study is to measure the cpm response and determine whether neural tensioner exercise in patients with chronic neck pain is effective in the improvement of neck pain intensity, neck disability and cervical range of motion. design: double-blind, randomized placebo clinical trial. methods: patients with neck pain will be randomly allocated into two groups: the neural tensionner exercise group (nte) or the sham technique (st) group. individuals will be included in the study if they meet the following inclusion criteria: aged 18-65 years, neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head. neck pain intensity with a visual analogue scale (vas), neck disability index (ndi), cpm, and cervical rang of motion will be measured pre and port intervention.


Eligibility criteria:
inclusion criteria: * aged 18-65 years. * neck pain perceived in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process with more than 12 weeks of evolution and without radicular symptoms radiated to the head, trunk, and/or the upper limbs. * the ability to understand, write, and speak spanish fluently exclusion criteria: * development of systemic or degenerative diseases; * symptoms of depression according to beck's questionnaire. * pain in any area between the lower back and the head in the last 9 months. * neck pain associated with whiplash injuries. * medical red flag history (i.e., tumour, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis). - neck pain with cervical radiculopathy. * neck pain associated with externalized cervical disc herniation. * fibromyalgia syndrome. * previous neck surgery. * neck pain accompanied by vertigo caused by vertebrobasilar insufficiency or accompanied by non-cervicogenic headaches due to a traumatic event in the past 12 months. * and history of neck or face pain in the last 6 months.

Keywords: pain measurement
a photoaging mobile app promoting poster campaign for preventing smoking in secondary schools

Conditions: Tobacco Addiction; Smoking Related Diseases; Adolescent Smoking

Summary: the purpose of this study is to determine whether photoaging mobile app promoting poster campaigns are effective to reduce smoking prevalence among adolescents in germany. this is measured via questionnaire.

this rct will investigate a novel mean of school-based tobacco prevention: photoaging app promoting poster campaigns. the effects are measured via questionnaire.

Eligibility criteria:
inclusion criteria: * students from germany aged 9 to 14 years at baseline attending grades six and seven of regular german secondary schools (such as grammar, general, intermediate or comprehensive school) are eligible. exclusion criteria: * older or younger pupils or pupils from other school types or countries or schools who previously participated in an event where the smokerface app was presented are not eligible.

Keywords: photoaging mobile apps adolescent smoking tobacco prevention school-based prevention adolescent health school health smoking tobacco
comparison of biphasic insulin aspart 30 twice daily with two different initial dosage split regimens in subjects with type 2 diabetes: an extension to trial biasp-3756

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin a1c (hba1c) below 7% in trial biasp-3756 (nct01123980).


Eligibility criteria:
inclusion criteria: * finalised 24 weeks of treatment with once daily biasp 30 or insulin glargine in combination with metformin and glimepiride in trial biasp-3756 * hba1c above or equal to 7.0% * body mass index (bmi) below or equal to 40.0 kg/m2 exclusion criteria: * known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial biasp-3756 * known proliferative retinopathy or maculopathy requiring acute treatment * any disease or condition which the investigator (trial physician) feels would interfere with the trial
comparison of the effect of device closure in alleviating migraine with pfo (compete-2)

Conditions: Migraine; Patent Foramen Ovale

Summary: migraine attacks are episodic disorder that affects approximately 12% of the population, and studies have shown that 41-48% of migraineurs have a combination of patent foramen ovale (pfo). clinical observational studies have been linking pfo occlusion with the effectiveness in improving migraine symptoms and reducing the frequency of attacks. however, several rcts have shown negative primary results, making it unclear whether pfo occlusion is effective in treating migraine. our study is a prospective, double-blind, multi-center, and randomized study designed to test the effectiveness of migraine alleviation by performing percutaneous closure of patent foramen ovale in patients who are also diagnosed with pfo and migraine.


Eligibility criteria:
inclusion criteria: 1. age 18-65 ； 2. diagnosed migraine by ichd-3 3. history of migraine longer than 1 year 4. tcd/tte/tee diagnosed patent foramen ovale 5. willing to participant and agree to follow-ups 6. undertook medication therapy for three months without a responder rate higher or equal to 50% exclusion criteria: 1. migraine caused by other reason 2. had tia/stroke history 3. hypersensitive or hyposensitive to the study drug
calcific tendinitis: comparing minimally invasive modalities

Conditions: Calcific Tendinitis

Summary: calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office. the chronic and variable course of the condition can lead to dissatisfaction with conservative management. current standard of care at the thunder bay regional health sciences centre is referral for treatment by either needle decompression therapy by a radiologist or shockwave therapy by a physiotherapist. the purpose of this study is to compare the efficacies of these treatment options.

calcific tendinitis is a common and challenging problem in the orthopedic surgeon's office. the chronic and variable course of the condition can lead to dissatisfaction with conservative management. current guidelines recommend conservative management initially and failing this, a variety of minimally invasive options exist. these include subacromial steroid injection (ssi), needle decompression (nd), and shock wave therapy (swt). few trials of these methods exist, but generally a benefit is seen with all minimally invasive methods. most promising results have occurred with needle decompression and shockwave therapy. to date, no direct trials comparing swt and nd have been published. the purpose of this trial is to preliminarily establish the comparative efficacies of ndssi and swt using a number of outcome measures. secondarily, the investigators aim to determine prognostic factors for success of minimally invasive therapies. the results of this study will serve as a foundation for more rigorous trials in this area.

Eligibility criteria:
inclusion criteria: * new diagnosis of symptomatic calcific tendinitis of the shoulder * seeking treatment for diagnosis * ≥ 18 years of age exclusion criteria: * pre-existing diagnosis of rotator cuff tear or arthropathy * previous minimally invasive or surgical therapy * systemic inflammatory disease * blood dyscrasia * peripheral neuropathy * active workplace safety \& insurance board (wsib) claim for shoulder injury
a study to evaluate how vi-0521 affect psychomotor performance in healthy overweight and obese subjects.

Conditions: Overweight; Obesity

Summary: the purpose of this study is to determine how vi-0521 affect speed and reaction time on specific tasks that require eye and hand coordination, compared to placebo.


Eligibility criteria:
inclusion criteria: * written consents; * adequate contraception from screening through 28 days after the last dose of study drug for female subjects; * healthy obese or overweight subjects with bmi between 27 and 35. exclusion criteria: * history of glaucoma or any past or present use of medications to treat increased intraocular pressure; * current use of any tobacco products, including cigarettes, cigars, pipes, or chewing tobacco, or use within the three months prior to screening; * history of drug abuse during the three years prior to screening; * history of alcohol abuse, or excessive alcohol consumption, or describes themselves as non-users of alcohol; * current depression of moderate or greater severity, or any presence or history of suicidal behavior or active suicidal ideation * more than one lifetime episode of major depression; * currently working night shifts at a job; * on average consumes greater than two cups of coffee or xanthine-containing beverages per day (\>200 mg/day) within the two weeks prior to screening; * any use of dietary, herbal, and/or fitness/body-building supplements (with the exception of vitamins) within one month prior to screening; * aspartate aminotransferase or alanine aminotransferase \>2.5 x uln; * serum creatinine ≥1.5 mg/dl for men or ≥1.4 mg/dl for women.

Keywords: overweight obesity coordination psychomotor
constrained balloon combined with drug-coated balloon angioplasty for femoropopliteal lesion

Conditions: Peripheral Arterial Disease

Summary: this study will assess the safety and efficacy of chocolate balloons as a combination with drug-coated balloons in the treatment of popliteal artery lesions in lower limb atherosclerotic occlusive disease and will compare them with conventional balloons.


Eligibility criteria:
inclusion criteria: * rutherford classification of 2-6 in patients with femoropopliteal atherosclerotic occlusive disease; * primary cases with no previous surgical treatment of the target lesion; * presence of at least one vessel with patency in the distal outflow tract; * survival \>1 year. exclusion criteria: * planned stenting; * presence of flow-limiting dissection prior to application of chocolate balloon and conventional balloon dilation of the target lesion; * combination of severe organ dysfunction of the heart, lungs and brain that cannot tolerate the procedure; * allergy to contrast agents, anaesthetic drugs, anticoagulants and anti-platelet drugs; * ineffective recanalization attempts; * lesions within or adjacent to the aneurysm, or the presence of a popliteal aneurysm.

Keywords: femoral artery popliteal artery peripheral artery disease chocolate percutaneous transluminal angioplasty balloon drug-coated balloon
fitline: pediatric practice-based obesity intervention to support families

Conditions: Obesity, Childhood

Summary: the goal of this study is to investigate whether eight weekly telephone coaching sessions or materials on lifestyle interventions can be beneficial for overweight and obese 8-12 year olds.

the proposed five-year cluster randomized controlled pediatric practice-based trial will compare the effectiveness of two practice-based interventions on improving diet and physical activity and reducing bmi among overweight and obese 8-12 year olds seen in pediatric practice: (1) fitline-coaching, consisting of a pediatric practice-based component plus fitline counseling and workbook, or (2) fitline-workbook, consisting of the same practice-based component, but only the family workbook materials mailed over 8 weeks, with no referral to fitline coaching. sixteen pediatric primary care practices will be randomized to either the fitline-coaching (n=8) or the fitline-materials (n=8) condition. five hundred and twelve parents and their children ages 8-12 with a body mass index (bmi) of \> 85th percentile (overweight or obese) will be recruited from the practices to achieve n=400 at 12 month follow-up.

Eligibility criteria:
inclusion criteria: 1. child bmi \>= 85th percentile for age/sex, 2. participating parent and child english speaking, 3. parent has access to a telephone and is available to participate in telephone counseling sessions, and 4. referred by the child's primary care provider. exclusion criteria: 1. planning to move out of the area during the period of study participation, 2. medical condition that precludes adherence to aap dietary and physical activity recommendations, 3. genetic or endocrine causes of obesity, 4. prescribed medications associated with weight gain, 5. child on psychiatric medications, and/or 6. morbidly obese (\> 300 pounds). -

Keywords: obesity