Kornimate/medical-research-clean huggingface dataset:
mpfl reconstruction with or without tibial tubercle transfer

Conditions: Patellar Dislocation

Summary: this study aims to compare the clinical outcome of medial patellofemoral ligament (mpfl) reconstruction with and without tibial tubercle transfer for recurrent patellar dislocation.

70 patients with recurrent patellar instability were randomly assigned to undergo mpfl reconstruction with or without tibial tubercle transfer. follow-ups were performed at 12 and 24 months postoperatively, and computed tomography (ct) was performed immediately after the operation and at follow-up. the knee function was evaluated preoperatively and at 2 years postoperatively using lysholm,tegner and kujala scales. redislocation or multiple episodes of patellar instability were considered failures.

Eligibility criteria:
inclusion criteria: * recurrent patellar dislocation or instability,patients with tt-tg value equal to or greater than 20 mm,patients with closed epiphyseal plate tt-tg：two lines drawn perpendicular to posterior bicondylar line, one line through middle of the trochlear groove(tg) and the second through tibial tuberosity (tt). distance between the lines is measured. exclusion criteria: * bilateral patellar dislocation, a previous surgery in the involved leg,patients with open epiphyseal plate,patients with severe trochlear dysplasia

Keywords: patellar dislocation medial patellofemoral ligament tibial tubercle transfer
study to assess the efficacy and safety of orismilast in atopic dermatitis (adesos)

Conditions: Atopic Dermatitis; Skin Diseases

Summary: this study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. the purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. the patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.


Eligibility criteria:
inclusion criteria: 1. capable of giving signed informed consent. 2. male and female patients ≥18 years of age 3. body weight of \>40 kg 4. diagnosis of ad for a minimum of 1 year (before the screening visit) using the hanifin and rajka criteria 5. moderate to severe ad (affected bsa at least 10%, iga-ad grade of at least 3, and easi score of at least 16) at the screening and baseline visits 6. candidate for systemic treatment or phototherapy for ad exclusion criteria: 1. therapy-resistant atopic dermatitis 2. unstable ad with acute deterioration, requiring rescue therapy for ad within 4 weeks of the screening visit or expected to require rescue therapy within 2 weeks after randomization 3. history of allergy or hypersensitivity to any component of the study treatment 4. active infection (eg, bacterial, viral, fungal) requiring treatment with systemic antibiotics within 4 weeks of the screening visit 5. malignancy or history of malignancy except for treated (ie, cured) basal cell skin carcinoma

Keywords: atopic dermatitis orismilast
dim as a treatment for thyroid disease

Conditions: Proliferative Thyroid Disease

Summary: diindolylmethane (dim), a dietary supplement, found naturally in cruciferous vegetables (such as cabbage, cauliflower, broccoli, \& brussels sprouts) has been studied extensively in recent years for its anti-cancer effects. dim has been shown to exert control over cancer cell growth in breast, uterine, cervical, ovarian, and colon cancer. to date no human study has been published regarding the bioavailability of dim in thyroid tissue or its effects in proliferative thyroid disease. our previous study attempted to elucidate dim's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease and ascertain its uptake in thyroid tissue. dim has been shown to concentrate in the thyroid gland. furthermore, thyroid volumes have been seen to decrease subjectively. this study would continue our attempt to elucidate dim's promotion of anti-proliferative estrogen metabolites in proliferative thyroid disease.


Eligibility criteria:
inclusion criteria: * adults diagnosed with abnormalities of the thyroid gland suspicious for benign adenoma, or goiterous changes. exclusion criteria: * patients who are pregnant, attempting to conceive, or lactating will be excluded due to possible deleterious effects of treatment on fetus/infant. patients taking oral contraceptives, estrogen therapy, tamoxifin or those with a history of breast cancer will be excluded. patients with liver disease and those taking statins for hypercholesterolemia will also be excluded to decrease the potential for possible liver toxicity. any patient with elevated liver enzymes on pretreatment blood screening will be excluded from study participation. patients with serious systemic diseases such as renal failure, diabetes, blood dyscrasia, coagulopathy, and non-optimized cardiopulmonary disease will be excluded due to the possibility of confounding blood tests screening for toxicity.

Keywords: thyroid dim
combination of nicotine replacement therapy (nrt) and varenicline to increase cessation of tobacco (convict study)

Conditions: Tobacco Dependence; Smoking Cessation

Summary: varenicline and nicotine replacement therapy (nrt) are both effective smoking cessation treatments. anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding nrt to varenicline. this proof-of-principle placebo-controlled double-blind study will examine whether combining nrt and varenicline provides better withdrawal and craving relief than varenicline alone. a total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. all participants will receive standard nhs stop smoking service support. the primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.


Eligibility criteria:
inclusion criteria: * smokers seeking treatment * aged 18 and over * consenting to take part in the trial exclusion criteria: * pregnant or breastfeeding * end-stage renal disease * unable to fill in questionnaires in english * previous allergy to varenicline * previous allergy to nicotine patches previous allergy to varenicline

Keywords: smoking cessation tobacco dependence varenicline nicotine replacement therapy combination therapy
evaluating the effectiveness of an acceptance and commitment therapy-based group intervention for parents of children with a diagnosis of autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: this study is being conducted to look at whether a group programme designed for parents of children with a diagnosis of autism is effective. the programme is called the start programme ©- as it aims to provide a supportive and therapeutic environment to help parents gain acceptance and reach resolution so that they can take action to live more consistently with their values. the programme was developed by two psychologists in longford/westmeath, ireland, dr. michelle howard and kara mcdermott in 2013, because they identified a lack of therapeutic support for such parents. the programme draws on research and theory from a branch of therapy called acceptance and commitment therapy, as well as some other psychological techniques. individuals who agree to participate in the research will be assigned at random to the intervention or to a treatment as usual control condition. they will be asked to fill out 4 questionnaires, on 3 different occasions, with a 7 week gap between the first time and second time, and a 3 month gap between the second and third time.


Eligibility criteria:
inclusion criteria: * participants must be adults over the age of 18 with the capacity to provide informed consent who are willing to take part in all aspects of the study * they must have at least 1 child with a diagnosed autism spectrum disorder who is linked in with one of the psychology service sites involved in the study. * they must not have completed the start programme before, or be concurrently attending another group based parental intervention. exclusion criteria: * individuals who are under the age of 18, or who unable or unwilling to provide informed consent for all aspects of the study will be not included. * individuals who are receiving other current group based parental interventions will not be included. * couples may not attend the programme together, as outlined by the psychologists who developed the programme.
brief mindfulness intervention for orthopedic patients

Conditions: Pain

Summary: this is a single-site, two-arm, parallel-group randomized clinical trial (rct). the clinical effects of a 4-minute audio-recorded mindfulness intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.


Eligibility criteria:
inclusion criteria: * age ≥18 * seeking foot or ankle treatment at the tallahassee orthopedic center exclusion criteria: * • cognitive impairment preventing completion of study procedures. * current cancer diagnosis, * other unstable illness judged by medical staff to interfere with study involvement.
a study to understand the long-term safety and effects of an experimental gene therapy for duchenne muscular dystrophy.

Conditions: Duchenne Muscular Dystrophy

Summary: the purpose of this study is to understand the safety and effects of an experimental gene therapy called fordadistrogene movaparvovec. we are seeking participants from previous pfizer interventional studies. we will follow participants' experience in this study for 10 years after the end of their previous study. participants will have 1 annual onsite visit and a few annual remote visits. the exact number of remote visits will be decided by their study doctor.


Eligibility criteria:
inclusion criteria: * participants who received fordadistrogene movaparvovec in a previous pfizer interventional study. exclusion criteria: * investigator site staff directly involved in the study and their family members

Keywords: duchenne muscular dystrophy muscular dystrophy, duchenne genetic therapy gene therapy
impact of exercise training intensity on abdominal visceral fat and risk factors associated with the metabolic syndrome

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to determine if sixteen weeks of high intensity physical training is more effective than sixteen weeks of low intensity physical training in reducing abdominal fat and lowering risk factors associated with the metabolic syndrome. another aim of this study is to determine if high intensity physical training improves cognitive function.


Eligibility criteria:
inclusion criteria: * volunteers must have meet the definition of the metabolic syndrome (based on idf consensus statement). * screening biochemical tests of liver, kidney, hematologic, metabolic (below) and thyroid function must be normal. * the volunteer must be willing to: 1. visit the outpatient gcrc or clinic once monthly for 16 weeks of intervention, 2. participate in supervised exercise training (if assigned) and 3. enter the inpatient gcrc for 2-3 days of more intensive studies at baseline and after 16 weeks of intervention. the subject must provide voluntary and fully informed written consent. exclusion criteria: * type 1 diabetes, * drug or alcohol abuse, * psychosis, * severe or untreated depression, * dementia, polycythemia (hematocrit \> 55%), * clinically symptomatic coronary artery, * pulmonary or orthopedic disease (which would disallow exercise training), * history of vascular or peripheral nerve trauma, * lymph node dissection, * anemia, uncontrolled hypertension (\> 160/105 untreated or \> 145/95 treated), * allergic to octafluoropropane, or nitroglycerine, * weight loss or gain of 2 kg or more within the preceding 10 days, * investigational drug use within five biological half-lives, * treatment with ace inhibitors or arbs, thiazolindiones, * 1st or 2nd generation anti-psychotics insulin, or viagra, * unwillingness to provide written informed voluntary consent, * pregnant, breast feeding or use hormonal birth control.

Keywords: metabolic syndrome obesity exercise diabetes physical activity
assessment of egfr genomic alterations as prognostic markers in cervical cancer

Conditions: Cervical Cancer; Cervix

Summary: the tissue repository will search for cases, pull slides, paraffin-embedded tissue (pet) blocks.

this study is done to gather preliminary data for determining the best way to test egfr expression in patients with cervical cancer who will receive treatment with egfr inhibitors in the future. this study is designed to obtain preliminary data of genomic and phenotypic alterations of the egfr pathway in high grade cervical intraepithelial lesions (hg-sil) and invasive cervical cancers (cc) to be used later for therapeutic guidance and to evaluate genomic (over-expression, amplification, point mutations, etc.) and phenotypic alterations of other transduction pathways interacting with the egfr pathway.

Eligibility criteria:
inclusion criteria: * samples from patients diagnosed with hg-sil (n=300) and cc (n=300) with a follow-up of at least 24 months, existing at the department of pathology will be retrieved by the tissue repository, de-identified them and provided with code numbers that will not be linked to patient's data. exclusion criteria: * none specified.

Keywords: cervical cancer egfr cervical genomic dna markers prognostic gene epidermal growth factor
weekly sirolimus therapy

Conditions: Venous Malformation; Lymphatic Malformation

Summary: in current practice, options for venous and lymphatic malformations remain limited. recently an oral medication, sirolimus, has been found to benefit patients when taken once or twice a day for several months. unfortunately there are many side effects associated with this medication, some of which can be severe including, neutropenia, oral ulcerations, and lab abnormalities. the purpose of this study is to determine if once weekly dosed sirolimus will be effective for the treatment of venous and lymphatic malformations. additionally, the study will evaluate patient satisfaction and identify adverse effects. participants will be on the medication for 6 months with an option to continue after this time period.


Eligibility criteria:
inclusion criteria: * patient 2 years of age and older * venous, lymphatic, or venolymphatic malformations exclusion criteria: * children with contraindication to use of sirolimus * children with history of transplant * children with a history of natural immunodeficiency * children with a history of artificially induced immunodeficiency * children with a history of a serious or life-threatening infection * children taking cyp3a4 inhibiting medications * children taking strong cyp3a4 inducers to avoid subtherapeutic dosing/exposure. * inability or unwillingness of subject or legal guardian/representative to give informed consent * women that are or may become pregnant o sirolimus is a pregnancy category c drug. no randomized controlled studies have been done on pregnant women. women of childbearing potential must be on effective contraception prior to, during, and for 12 weeks following sirolimus therapy.
comparison of fimasartan versus amlodipine therapy on carotid plaque inflammation

Conditions: Inflammation Plaque, Atherosclerotic; Coronary Disease; Renin-Angiotensin System

Summary: the purpose of this study is to evaluate the effects of angiotensin receptor 1 blocker versus calcium channel blocker on atherosclerotic plaque inflammation using serial fdg pet/ct imaging of carotid artery.


Eligibility criteria:
inclusion criteria: * men or women at least 18 years of age inclusive * patients with acute coronary syndromes or unstable angina pectoris * hypertension or blood pressure more than 140/90mmhg * fdg pet/ct shows at least 1 hot uptakes at carotid and or ascending aorta * the patient or guardian agrees to the study protocol and the schedule of clinical and fdg pet/ct follow-up, and provides informed, written consent, as approved by the appropriate institutional review board/ethical committee of the respective clinical site. exclusion criteria: * patients treated with carotid endarterectomy or stent placement * chronic disease requiring treatment with oral, intravenous, or intra-articular corticosteroids (use of topical, inhaled, or nasal corticosteroids is permissible). * untreated hyperthyroidism, or hypothyroidism * any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the investigator, would preclude safe completion of the study. * evidence of congestive heart failure, or left ventricular ejection fraction \< 40%. * significant renal disease manifested by serum creatinine \> 2.0mg/dl, or creatinine clearance of \< 40 ml/min (by cockcroft-gault method). * hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (alt or ast \> 3 times upper limit of normal). * history of adult asthma manifested by bronchospasm in the past 6 months, or currently taking regular anti-asthmatic medication(s). * unwillingness or inability to comply with the procedures described in this protocol. * patient's pregnant or breast-feeding or child-bearing potential. * type i diabetes

Keywords: fluorodeoxyglucose f18 positron-emission tomography and computed tomography plaque, atherosclerotic renin-angiotensin system
game-based intervention to reduce alcohol-related harms among sexual and gender minority youth

Conditions: Alcohol Problem; Harm Reduction; Alcohol-Related Harm

Summary: this is a randomized controlled trial to examine the efficacy of a game-based intervention to reduce alcohol-related harms among sexual and gender minority youth.


Eligibility criteria:
inclusion criteria: * able to participate in english * live in the u.s., * 14-18 years old * have a sexual minority identity (i.e., gay, lesbian, bisexual, or queer) or a gender minority identity (i.e., consider themselves to be transgender or nonbinary), * have an internet-accessible computer, smart phone, or tablet, * provide an email address. * have drank alcohol in their lifetime or intend to in the next year. exclusion criteria: * cisgender heterosexuals.
the head injury-associated photosensitivity and pupillary function (hipp) study

Conditions: Head Injury; Traumatic Brain Injury (TBI); Photosensitivity; Photophobia

Summary: after a head injury, many people find that exposure to light causes them increased discomfort. by measuring how the pupil in the eye constricts to flashes of red and blue light, this study will investigate whether this phenomenon is due to a change in the eye's sensitivity to light.

the pupils inside the eyes constrict in response to light stimulation. different classes of cells within the human retina initiate this response. recent research suggests that one of the ganglion cell types involved in this pupil response also plays a role in the photophobia experienced by migraine sufferers. the main aim of this study is to determine whether this type of ganglion cell becomes 'hypersensitive' after traumatic brain injury, thereby contributing to symptoms of increased photosensitivity experienced by many of these individuals. in the first session of this study, subjects will be asked questions about their sensitivity to light and the reaction of their eyes' pupils to flashing red and blue lights will be measured. the subjects will be given a full eye examination to rule out other causes of increased photosensitivity. in some cases, subjects will be asked to attend a second session roughly two weeks later. they will be asked to wear a watch that measures their daily activity/sleep rhythms and light exposure during this inter-session period. during the second session, further testing of the pupil responses to blue and red flickering light will be performed.

Eligibility criteria:
inclusion criteria: * 18+ years old * reports a previous head injury that occurred at least 6 months ago * score of 2 or 3 (mild tbi) on osu-tbi id survey * best-corrected visual acuity of at least 20/30 in both eyes * reliable visual field exclusion criteria: * pregnancy * significant afferent pupillary defect * previous history of neurodegenerative disease * intraocular pressure more than 21 mm hg * significant visual field defect * active corneal pathology * history of retinal or optic nerve disease * strabismus (eye turn)

Keywords: traumatic brain injury photophobia photosensitivity pupil
sexually dimorphic effects of ghrh in adult growth hormone testing

Conditions: Growth Hormone Deficiency

Summary: specific aim 1 healthy male and female subjects and growth hormone (gh) deficient subjects display sexually dimorphic gh responses to ghrh administration specific aim 2 gh responses to ghrh in both healthy controls and in gh deficient patients correlate with expression and activity of the stimulatory g proteins, g alpha q and g alpha s. g protein levels correlate with gonadal steroid levels. specific aim 3 sexually dimorphic gh responses to ghrh are enhanced in tanner stage v compared to tanner stage 1 individuals

growth hormone deficiency affects disproportionately more males than females. although ascertainment bias plays a role in this sexual dimorphism, no plausible mechanism to fully explain this difference has been proposed. this investigator initiated study will provide currently unavailable data on sexual/age differences in response to gh stimulation testing. data obtained from the study may provide a basis for developing appropriate normal ranges for adult gh testing, may provide a plausible mechanism for the enhanced hormone responsiveness observed in females, and may provide data on when the sexual differences to gh stimulation may develop. the objectives of this study are to: 1. confirm the sexual dimorphism in growth hormone responses for adult growth hormone testing in healthy male and female subjects 2. correlate peak growth hormone releasing hormone (ghrh)/arginine induced growth hormone responses with g protein levels in healthy subjects and in patients with a history of childhood gh deficiency 3. determine whether sexual dimorphism is acquired during puberty

Eligibility criteria:
inclusion criteria: healthy subjects * males and females, tanner stage v aged 15-40 years of age with no known endocrine problems * males and females, tanner stage i, aged 5-8 years with no known endocrine problems gh subjects - males and females, tanner stage v, aged 15-21 years with a history of childhood growth hormone deficiency exclusion criteria: healthy subjects * history of gh deficiency or treatment or other known endocrine disorder * current height or adult height \<5th % * female subjects using hormonal methods of birth control * female subjects with irregular menstrual cycles gh subjects - subjects with gh deficiency who have not discontinued gh treatment for at least 2 months

Keywords: growth hormone deficiency
68ga-psma pet/ct imaging in assessment of prostate cancer

Conditions: PET/CT; Prostate Specific Membrane Antigen; IMAGE

Summary: dual-time point 68ga-psma pet/ct could increase the lesion detection in pca patients, it remains difficult to perform in clinical practice. the possibility of one-time point 68ga-psma pet/ct imaging could be achieved using a total-body pet/ct.


Eligibility criteria:
inclusion criteria: * primary staging of pathology-confirmed pca or evidence of bcr with psa value \> 0.2 ng/ml * positive 68ga-psma findings * both standard and delayed scans were performed on the total-body pet/ct exclusion criteria: * only one scan was performed * negative psma results