Kornimate/medical-research-clean huggingface dataset:
wisconsin tobacco quit line medicaid incentive evaluation

Conditions: Smoking; Smoking Cessation; Nicotine Dependence

Summary: the study is designed to test the hypotheses that financial incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to badgercare plus (medicaid) smokers as part of their health care.

previous research on providing incentives for healthy behaviors has shown that financial incentives can increase treatment participation and boost outcomes when they are tied to participation in evidence based treatments. however, most of this research has been done in laboratory settings and in relatively small clinical trials. this study is designed to test the hypotheses that incentives can increase both participation in smoking cessation treatment and resulting cessation rates, when they are offered to wisconsin badgercare plus (medicaid) smokers as part of their health care. if successful, this treatment approach could be used more broadly to reduce the considerable financial and personal costs associated with smoking-related disease. in this study, medicaid-eligible smokers were recruited from primary care clinics and from callers to the wisconsin tobacco quit line (wtql) with randomization a control condition and an incentive condition. all participants were offered five cessation calls from the wtql and participants were encouraged by wtql coaches to obtain cessation medication from their primary care providers. all participants received payment for completing a baseline assessment ($40) and a 6-month smoking test ($40). only incentive condition participants received additional compensation for taking counseling calls ($30 per completed call) and for biochemically-verified abstinence at the 6-month visit ($40).

Eligibility criteria:
inclusion criteria: * enrollment in wisconsin medicaid (badgercare plus) * resides in study area (one of 25 counties) * 18 or older * english or spanish speaking * has smoked daily (at least 5 cigarettes each day) over the last week * willingness to attend visits at his/her pcc (primary care clinic) or go to a testing site at baseline and 6 months (2 times over a 6 month period), provide urine samples or participate in exhaled carbon monoxide testing, and complete follow-up phone calls from the wtql * willingness to inform the wtql as to any change in address, phone number, clinic attended, or health plan. exclusion criteria: * not enrolled in wisconsin medicaid (badgercare plus) * not reside in study area * less than 18 years of age * not english or spanish speaking * does not smoke daily (at least 5 cigarettes each day) over the last week * not willing to attend visits at his/her pcc (primary care clinic) or alternative testing site at baseline and 6 months (2 times over a 6 month period), provide urine or exhaled carbon monoxide samples, and complete follow-up phone calls. * not willing to inform the wtql as to any change in address, phone number, clinic attended, or health plan.
the effect of mucogyne® gel on wound healing

Conditions: Perineal Tear and Episiotomy

Summary: the aim of this post-market clinical follow up study is to confirm the efficacy and safety of topical application of mucogyne® gel in the process of wound healing, when used in accordance with its approved labeling, in the context of postpartum perineal wounds.


Eligibility criteria:
inclusion criteria: 1. adult women with singleton pregnancy 2. have a perineal tear or mediolateral episiotomy 3. first (with cutaneous injury) and 2nd-degree perineal tear/episiotomy, whose length and depth are as the following: * depth (from the fourchette into the greatest depth of the perineal body) ≤3cm, * length of vaginal mucosa (from the fourchette to the apex of the vaginal tear) ≤4cm * length of skin (from the fourchette along perineal skin towards the anus) ≤3cm 4. is able to understand the study related information and to give a written informed consent, 5. has signed the informed consent form before beginning any study procedure, 6. has no condition that may interfere with the study assessments, 7. is able to comply with protocol requirements and respect the conditions of the study, 8. accept to come to the mentioned hospital 12(+/-2) days after childbirth 9. affiliated to the social security system exclusion criteria: 1. postpartum complications, or developed early bleeding after delivery 2. third and fourth degree perineal tear. 3. previous vaginal/perineal surgery within the year preceding the inclusion in the study 4. had undergone extended episiotomy (incision size \> 3 - 4 cm) 5. anal fissures. 6. known hypersensitivity to any of the medical device ingredients 7. with local infectious lesions in the area to be repaired. 8. who use drugs known to disturb wound healing (example : anticoagulants during pregnancy (based on self-reports)) 9. had a history of diseases known to disturb wound healing (e.g. systemic, heart, and renal diseases, coagulation disorders, immune deficiency, connective tissue disorders, diabetes, anemia (with hemoglobin level \< 9 g/dl) and hemophilia) 10. immunosuppressive treatment. 11. heavy cigarettes smoker (i.e., more than 15 cigarettes or equivalent/day, according to the mothers and their documented records), 12. patients under legal protection or under guardianship and patients deprived of freedom 13. has any other severe chronic or acute medical or psychiatric condition that in the judgment of the investigator, could interfere with the study assessments
hypertonic saline as therapy for pediatric concussion

Conditions: Pain

Summary: this single center, blinded, randomized controlled trial evaluated the use of hypertonic saline versus normal saline as therapy for the symptoms of pediatric concussion post head injury. the study hypothesis was that hypertonic saline would improve symptoms of pediatric concussion following head injury as measured on the self-reported wong baker faces pain scale as compared to normal saline. the null hypothesis was that there would be no difference in change of reported pain in either group.


Eligibility criteria:
inclusion criteria: * 4-17 years old * consent obtained * pain as a symptom of concussion * head ct negative for intracranial pathology exclusion criteria: * younger than 4 years or older than 17 years * multi trauma * cardiac, neuro, renal history of disease * seizure * narcotic, drug use * pregnancy * head ct with traumatic intracranial pathology * no consent
research of predictive factors of in vitro fertilization (ivf) outcome ai-ivf study

Conditions: Autoimmune Diseases

Summary: infertility is the failure to achieve a clinical pregnancy after 12 months or more of regular unprotected intercourse, while subfertility means a delay in achieving pregnancy. several factors can contribute to these conditions, such as autoimmune diseases like systemic thyroid and celiac diseases, rheumatoid arthritis, systemic lupus erythematosus, and endometriosis. some of them may overlap, sharing a common immunological milieu. in this scenario, medically art can help women carry on pregnancies if they are in stable disease remission and receive adequate treatment. however, the number of oocytes that can be ovulated under stimulation is highly variable, so the outcome of any ivf is linked to many factors, not only biological but also connected to the mean success rate of the fertility center. for these reasons, the need to find methods for identifying the best gametes and embryos to guarantee a successful pregnancy is becoming pressing. ai can be essential to develop prediction models for pregnancy outcomes for patients undergoing art treatments. ai currently represents a modern way to obtain algorithms from a set of observable data that could help clinical decisions


Eligibility criteria:
inclusion criteria: * women with age below 43 years old * ivf cycle with fresh semen sample that could be used * progressive motile spermatozoa expected count of minimum 1 million following density gradient purification on the day of oocyte pick up exclusion criteria: * women with uterine abnormalities * women with chromosomal and genetic abnormalities * positivity to serological test (hcv, hbv, hiv, vdrl-tpha)
study of low adherent dressing versus the standard of care for the management of skin grafts over thermal burns

Conditions: Burns; Skin Burn Requiring Skin Graft

Summary: the purpose of this study is to evaluate the p6 low adherent study dressing relative to the standard of care (soc, mafenide acetate 5% solution) for the management of skin grafts in burn wounds resulting from thermal burn injuries.


Eligibility criteria:
inclusion criteria: * patients must have thermal burns from scalds, flame/fire or contact with a hot object. * patients must have a tbsa burn of less than or equal to 50%. * patients must have two nonadjacent study burn sites (i.e., separated in such a way that soc dressing does not contaminate the study dressing) of comparable size (up to approximately 2% tbsa) and severity requiring excision and grafting. * patients must have undergone excision and autografting on or before post-burn day (pbd) 14. * patients' study burn sites will be treated with skin grafts with a mesh ratio up to 3:1, at the surgeon's discretion. * patients expected to be available for assessment of study burn sites at least until pod 6 ±1 day. * males or females at least 18 years of age but no older than 65 years of age at the time of informed consent. * patient and / or legally authorized representative (lar) voluntarily agrees to provide written informed consent and the willingness and ability to comply with all aspects of the protocol. exclusion criteria: * patients with electrical or chemical burns. * patients with a study burn site excised and "grafted" with integra. * patients with study burn sites on the buttocks, scalp, hands, feet, neck or ears. * patients taking vasopressors or inotropes. * patients using systemic immunosuppressants (e.g., corticosteroids and anti-neoplastic agents, etc.). * patients with acute renal failure, defined as creatinine clearance (crcl) \>2.5 mg/dl or akin score greater than or equal to 2 or estimated gfr \< 30, if the assessment is conducted as part of the patient's routine clinical care. * patients with acute respiratory distress syndrome (ards), if the assessment is conducted as part of the patient's routine clinical care. * patients with liver cirrhosis (childs-pugh b class or greater) or who have ast / alt levels greater than or equal to 2 times the upper limit of theinstitution's normal range, if the assessment is conducted as part of the patient's routine clinical care. * patients with a known sensitivity or known intolerance to mafenide acetate (sulfamylon) or to silver. * patients with any concurrent medical condition, which in the opinion of the investigator, may compromise their safety or the objectives of the study. * patients who are breastfeeding, pregnant or expecting to become pregnant during the study.. * patients who have been exposed to an investigational drug or device within 30 days prior to screening or is scheduled to receive another investigational drug or device during either the treatment phase or follow-up evaluation.
biatain ibu vs. biatain in painful chronic venous leg ulcers

Conditions: Leg Ulcers

Summary: the objective of this investigation is to demonstrate the effectiveness and safety of biatain ibu non-adhesive foam dressing compared to biatain non-adhesive foam dressing.


Eligibility criteria:
inclusion criteria: * \>= 18 years of age * chronic venous leg ulcer on the lower leg * ulcer duration \>= 8 weeks * pain intensity in study ulcer at least 4 on an 11-point numerical box scale (nbs): 0= no pain, 10= worst possible pain * exudate level moderate to high * ulcer size min 1.6 cm and max 11 cm in any direction * ankle/brachial index \>= 0.8 * treated with moist wound healing during the past 2 weeks prior to inclusion * adequate compression therapy during the past 2 weeks prior to inclusion * the patient is cognitive capable of evaluating his/her pain relief and pain intensity * the patient is able to understand the treatment and is willing to comply with the treatment regimen. * the patient is able to complete the patient diary * the patient is willing and able to give written informed consent exclusion criteria: * painful ulcers that have been treatment resistant to analgesics for the past 6 months or more * pregnant or lactating women * known and verified hypersensitivity to any content of the products used in this investigation * local infection (bacterial imbalanced wound) in the study ulcer * clinical infection in the study ulcer * diseases: vasculitis, erysipelas and cellulitis of the peri-ulcer skin * the investigator considers the patient not eligible * diseases and conditions where ibuprofen or other analgesics are contraindicated (including known hypersensitivity to aspirin (acetylsalicylic acid) or other analgesics, especially associated with a history of asthma, rhinitis or urticaria) * diabetes * use of per need medication for the past 3 days * concomitant treatment with systemic antibiotics other than nitrofurantoin * concomitant treatment with systemic corticosteroids (more than 10 mg/day prednisolon or equivalent) or other immunosuppressants within 1 month prior to inclusion * concomitant treatment with cancer chemotherapeutics * concomitant participation in other studies * previous participation in this study
to evaluate the lipid-lowering efficacy and safety of simvastatin 40 mg tablet in patients with hypercholesterolemia (0733-264)

Conditions: Hypercholesterolemia

Summary: to collect lipid-lowering response data with the use of simvastatin 40 mg tablet in patients with hypercholesterolemia.


Eligibility criteria:
inclusion criteria: * male or female patient, \>18 years of age * patients with hypercholesterolemia who meet the following lipid criteria: 1. primary cholesterolemia: total cholesterol\>=240 mg/dl or ldl-c \>= 160 mg/dl 2. secondary cholesterolemia (patients with cad, dm): ldl-c\>=130 mg/dl * the patient is willing to follow an ncep therapeutic lifestyle changes (tlc) or similar cholesterol-lowering diet throughout the duration of the study exclusion criteria: * congestive heart failure (nyha class iii or iv), uncontrolled cardiac arrhythmias, unstable angina pectoris * myocardial infarction, coronary artery bypass surgery, or angioplasty within 3 months of visit 1 * uncontrolled hypertension with systolic blood pressure \> 160 mmhg or diastolic \> 100 mmhg at visit 1. * unstable diabetes (hba1c \>9%) or newly diagnosed (within 3 months)or change in anti-diabetes medications within 3 months of screening
investigation of q angle in osteoporosis patients

Conditions: Osteoporosis

Summary: osteoporosis (op) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. there are no studies evaluating q angle in patients with op and osteopenia (opn) in the literature. therefore, the aim of this study was to examine the q angle in patients diagnosed with op and opn and to compare it with patients diagnosed with oa. the study will be carried out by measuring the q angle measurement with a goniometer. pain assessment will be done with visual analog scale (vas). lower extremity muscle strength will be assessed with the medical research council (mrc) scale. foot posture will be assessed with the foot posture index (fpi).

osteoporosis (op) is a bone disease characterized by reduced bone density and deterioration of bone tissue, leading to an increased risk of fractures. according to calis et al; it was found that patients with hip fracture had a significantly higher q angle compared to patients without hip fracture. according to you et al; contraction of the quadriceps muscles corrects the q angle, therefore sports that use high amounts of quadriceps (strength) training are associated with lower q angles due to the pulling effect of the quadriceps muscle. there are no studies evaluating q angle in patients with op and osteopenia (opn) in the literature. therefore, the aim of this study was to examine the q angle in patients diagnosed with op and opn and to compare it with patients diagnosed with oa. the study will be carried out by measuring the q angle measurement with a goniometer. pain assessment will be done with visual analog scale (vas). lower extremity muscle strength will be assessed with the medical research council (mrc) scale. foot posture will be assessed with the foot posture index (fpi).

Eligibility criteria:
inclusion criteria: * be willing to participate in the study. * being between the ages of 40-65. * being a woman. exclusion criteria: * patellofemoral abnormalities during examination. * acute traumatic patellofemoral dislocations * surgical revision around the knee * history of any previous lower extremity surgery * serious trauma

Keywords: osteoporosis osteopenia q angle
effect of fdg-pet/ct for simulation and radiation treatment planning in oral cancer patients

Conditions: Oral Cancer; Radiotherapy; Complications

Summary: this study evaluates the effect of fdg-pet/ct for simulation and radiation treatment planning in oral cancer patients. progress-free survival (pfs) will be compared with historical control as defined in the protocol

radiotherapy improves local control and overall survival for oral cavity cancer patients after surgery. however, limited locoregional control remains a key issue in the management of oral cavity carcinomas. appropriate target selection is a key issue in the radiotherapy of oral cavity cancer. the purpose of this study is to determine the locoregional control in pet/ct based radiotherapy treatment planning in the treatment of oral cancer

Eligibility criteria:
inclusion criteria: * histologically confirmed oral squamous-cell carcinoma * age \> 17 years * signed informed consent * ecog performance status 0-2 * must be able to start rt within 4 weeks after pet/ct simulation exclusion criteria: * stage iv disease diagnosed before acquisition of staging pet/ct * prior radiotherapy to oral and neck * unable to understand study participation * claustrophobia * pregnant or breast feeding mothers

Keywords: pet/ct
comparison of 2 different flow rates during oocyte retrieval

Conditions: Infertility

Summary: the purpose of this study is to evaluate the effect of different flow rates during oocyte retrieval, on the number of cumulus oocyte complexes (cocs) retrieved.

in the current study, each ovary will be randomly allocated to oocyte retrieval using 0.42 ml/sec or 0.62 ml/sec flow rate. the primary endpoint will be the number of oocytes retrieved, while secondary outcomes will include oocyte recovery rate (number of oocytes retrieved per follicle aspirated), number of mature oocytes, maturation rate (number of mature oocytes/number of oocytes retrieved), mean oocyte score (by evaluating oocyte shape and size, ooplasm characteristics, structure of perivitelline space (pvs), structure of zona pellucida (zp) and polar body (pb) morphology), fertilization rate (number of fertilized oocytes/number of mature oocytes), number of blastocysts and blastulation rate (number of blastocysts/number of 2pn). patients aged 18-43 years with the presence of at least 3 follicles ≥ 11mm in each ovary on the day of oocyte retrieval will be eligible for inclusion in the study. prior to oocyte retrieval in eligible patients their left and right ovary will be randomly allocated into the 0.42 ml/sec or 0.62 ml/sec flow rate group. randomisation with minimisation will be employed. the specific flow rates will be achieved by adjusting the aspiration pressure of the vacuum pump accordingly. a study nurse will be responsible for adjusting the aspiration pressure of the vacuum pump depending on randomization. the doctor performing the oocyte retrieval will not be aware of the flow rate used in each ovary. all follicles will be aspirated and then flushed if needed up to a maximum of 5 times with an open flushing technique, using a 16g double-lumen needle. data will be registered regarding the number of flushes required to retrieve a coc, the morphology of oocytes after denudation, oocyte fertilisation and embryo development up to the blastocyst stage.

Eligibility criteria:
inclusion criteria: * presence of both ovaries * 18-43 years old * at least 3 follicles ≥ 11mm in each ovary on the day of oocyte retrieval exclusion criteria: * one or no ovaries present * monofollicular development * poor responders * previous history of hemorrhage during oocyte retrieval

Keywords: flow rate aspiration pressure oocyte retrieval
trial of acupuncture in the treatment of fibromyalgia

Conditions: Fibromyalgia; Diffuse Myofascial Pain Syndrome; Fibromyalgia-Fibromyositis Syndrome; Fibromyositis-Fibromyalgia Syndrome; Myofascial Pain Syndrome, Diffuse

Summary: fibromyalgia is a medical condition characterized by musculoskeletal pain, fatigue, sleep disturbances and depression. it affects population at a socioeconomically active age and represents a burden for the patients and the health care system due to its personal and functional implications. at this moment, there is no completely effective treatment for fibromyalgia, and acupuncture has been a promising alternative. this trial aims to evaluate if addition of acupuncture to standard care represents an improvement in comparison with standard care only. thus, patients enrolled in this trial will be randomly allocated into one of two groups: group a, who besides standard treatment will receive 12 sessions of acupuncture; and group b, who will receive standard care with monthly orientation sessions for the same period. patients will be evaluated at baseline, after completion of acupuncture treatment or orientation, and after an additional 12-week follow up. evaluation will be based on diaries of pain and medication, and standard scales of pain, quality of life and disability.


Eligibility criteria:
inclusion criteria: * american college of rheumatology criteria for fibromyalgia * elementary school * drug treatment for at least 30 days (if any) exclusion criteria: * disabling mental condition * other rheumatic conditions * other chronic medical conditions with musculoskeletal symptoms * pregnancy * conditions that impair walking * conditions that impair weekly consultations * acupuncture treatment in the twelve-month period prior to enrollment * diabetes mellitus

Keywords: fibromyalgia acupuncture randomized controlled trial pain quality of life
detection of subclinical enthesitis by ultrasonography

Conditions: Enthesitis

Summary: detection of subclinical enthesitis by ultrasonography

a total of 30 patients with psoriasis and 30 age-matched healthy controls, all without musculoskeletal diseases, will be recruited. they will undergo dermatological assessment and a blinded ultrasound (us) evaluation. clinical assessment included demographics, severity of psoriasis and musculoskeletal clinical examination. evaluation consisted of the detection of grey scale (gs) enthesitis and power doppler signal in enthesis areas. the madrid sonography enthesitis index (masei) scoring system was used to quantify the extent of sonographic entheseal abnormalities.

Eligibility criteria:
inclusion criteria: * age≥18years * patients with psoriasis without musculoskeletal symptoms * healthy controls * no joint involvement and no clinical symptoms and signs of enthesitis and synovitis exclusion criteria: * have history of gout or arthritis or peripheral neurological disease of lower extremity. * have history of trauma and intensive sport activity in last 2 weeks. * have received any systemic therapy (i.e. dmard, nsaids, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months * pregnant or breast-feeding

Keywords: subclinical enthesitis psoriasis ultrasound psoriatic arthritis