Kornimate/medical-research-clean huggingface dataset:
assessment of the efficacy of polygynax® in the empirical treatment of infectious vaginitis

Conditions: Vaginitis

Summary: polygynax® is a broad spectrum combination of nystatin, neomycin and polymixin b indicated for the local treatment of vaginitis due to sensitive germs and treatment of non specific vaginitis of adults. polygynax® has been marketed in france since 1969. nevertheless, despite the well established use of polygynax®, there is no clinical study supporting the interest of the combination of antifungal and antibiotics agents versus antifungal agent alone. the aim of this project is to demonstrate that polygynax® is more effective than miconazole in the treatment of women experiencing symptoms of infectious vaginitis.


Eligibility criteria:
inclusion criteria: * patient with an abnormal vaginal discharge associated with one (or more) functional vaginal complaints: vaginal burning and/or vaginal pain and/or vaginal irritation clinically evoking an infectious vaginitis: * bacterial vaginitis * non-specific vaginitis (atypical symptoms) * mixed vaginitis (i.e. suprainfected fungal vaginitis) and able to receive an empirical local treatment exclusion criteria: 1. recurrent patient; i.e. a patient who has had at least 4 episodes of infectious vaginitis in the 12 months prior to inclusion 2. vaginal infection justifying systemic therapy 3. history of atrophic vaginitis or suspected atrophic vaginitis at inclusion 4. patient presenting with signs of genital herpes or signs of non-infectious vulvar pathology (vulvodynia, psoriasis, eczema, lichen sclerosus, lichen planus, contact dermatitis, candida intertrigo, vulval intraepithelial neoplasia (vin)) 5. patient with current sexually transmitted infection (sti) and/or patients with clinical suspicion of sti 6. disease or concomitant treatment that could cause decreased immunity (i.e. diabetes mellitus, corticosteroids treatments) 7. systemic anti-infective treatment (antibiotic, antifungal) within two weeks prior to inclusion 8. patient menstruating or patient with menometrorrhagia due to hormonal imbalance at the time of inclusion 9. pregnant or lactating women or delivery within last 1 month
posthemorrhoidectomy pain management with electronic bidet or sitz bath

Conditions: Hemorrhoid

Summary: the investigator will perform a randomized clinical trials to compare the effect of pain management and wound healing after hemorrhoidectomy between warm sitz bath and electronic bidet.

after hemorrhoidectomy, the patients should take warm sitz bath for relieving pain and inducing wound healing. electronic bidet is a device for cleansing the anus after defecation, and some patients are using the bidet for sitz bath. thus, the investigator perform this study for comparing the effect of pain and wound management after hemorrhoidectomy between sitz bath and electronic bidet

Eligibility criteria:
inclusion criteria: * the patients who undergo hemorrhoidectomy exclusion criteria: * previous history of anal surgery * crohn's anal disease * perianal complex abscess or fistula * uncontrollable medical disease * tb * hiv * malignancy * immunocompromised * pregnancy * breast feeding * nsaid allergy

Keywords: hemorrhoidectomy postoperative pain sitz bath electronic bidet
shoulder training: muscle recruitment patterns and the effect of an exercise program

Conditions: Shoulder Impingement

Summary: the purpose of this study is to investigate the muscle recruitment pattern and the effect of a 6 week shoulder exercise training program in healthy persons and subjects with shoulder impingement


Eligibility criteria:
inclusion criteria: * current reported history of shoulder pain localised at the glenohumeral joint diagnosed as impingement * two positive shoulder impingement tests * pain reproduction during two of three additional categories of clinical tests * the subject is able to perform pain-free arm elevations with a resistance of 0.5 kg exclusion criteria: * cervical and periscapular pain * positive labral injury tests * history of shoulder surgery
reducing diabetes risk factors in american indian children: tribal turning point

Conditions: Overweight/Obesity

Summary: this study will evaluate a behavioral intervention designed to reduce risk factors for type 2 diabetes in american indian youth aged 7-10 years.

the objectives of tis study are to rigorously evaluate the effect of tribal turning point (ttp) on diabetes risk factors in native youth. the investigators will enroll up to 360 youth who are aged 7-10 years, overweight/obese (bmi \>85th percentile), self-identify as american indian, and have \>1 parent/primary caregiver willing to actively participate in the program. within each community, youth will be randomized to the ttp program or a general health and safety control program. the multi-component ttp intervention is a youth-centered adaptation of the diabetes prevention program designed to reduce diabetes risk factors by improving activity and dietary behaviors. informed by the pediatric weight management literature, the 12-month intervention includes 12 active learning group classes, 7 individual youth/parent motivational interviewing counseling sessions, and community-specific resource toolboxes. in this trial, the investigators will assess the effect of ttp on anthropometric, metabolic, and behavioral risk factors for type 2 diabetes at the end of the intervention (12mo) and after 1 year of follow-up (24mo).

Eligibility criteria:
inclusion criteria: * self-identify as american indian * bmi \>=85th percentile for age and sex * have at least one parent/primary caregiver (parent) willing to actively participate exclusion criteria: * diabetes * any serious youth/parent health concerns that would interfere with participation * plans to move out of the area during the study period
premium migraine trial

Conditions: Migraine Headaches; Patent Foramen Ovale

Summary: the purpose of this study is to evaluate the impact of percutaneous closure of a patent foramen ovale (pfo) (a hole in the heart), using the amplatzer pfo occluder, on the incidence of migraine headaches.

the objective of this study is to evaluate whether percutaneous pfo closure is effective in reducing the incidence of disabling migraine headaches in patients who are refactory to medical treatment.

Eligibility criteria:
inclusion criteria: * subjects diagnosed as having migraine headaches both with and without aura * have a patent foramen ovale (pfo) * a migraine history and show a refractoriness to medical treatment * willing to participate in follow-up visits exclusion criteria: * subjects whose primary headaches are other than migraine headaches * who overuse migraine treatments * with a clinical history of stroke or transient ischemic attack (tia) * with contraindication to aspirin therapy and clopidogrel * pregnant or desire to become pregnant within the next year

Keywords: migraine pfo migraine headache patent foramen ovale
coenzyme q10 in relieving treatment-related fatigue in women with breast cancer

Conditions: Breast Cancer; Fatigue

Summary: rationale: coenzyme q10 is a vitamin that may be effective in relieving fatigue and depression in women who are undergoing chemotherapy for breast cancer. purpose: this randomized clinical trial is studying how well coenzyme q10 works in relieving treatment-related fatigue in women with breast cancer.

objectives: primary * determine the effect of coenzyme q_10 on cancer treatment-related fatigue in women with breast cancer. secondary * determine the effect of this drug on overall quality of life of these patients. * determine the effect of this drug on depression in these patients. outline: this is a randomized, double-blind, placebo-controlled study. patients are stratified according to planned radiotherapy (yes vs no) and type of chemotherapy (anthracycline vs non-anthracycline). patients are randomized to 1 of 2 treatment arms. * arm i: beginning on the first day of chemotherapy treatment, patients receive oral coenzyme q_10 and oral vitamin e three times daily. * arm ii: beginning on the first day of chemotherapy treatment, patients receive oral vitamin e and an oral placebo three times daily. treatment in both arms continues for 24 weeks in the absence of unacceptable toxicity. quality of life, fatigue, and depression are assessed at baseline and at 8, 16, and 24 weeks. projected accrual: a total of 101-236 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * signed consent * hg \> 11g/dl; supportive measures (erythropoietin, transfusion, iron therapy) should be utilized to assist with maintaining hgb levels * total cholesterol \> 160mg/dl. * female with primary cancer diagnosis (breast) * planned adjuvant chemotherapy (neoadjuvant chemotherapy is excluded) * kps \> 60 * bilirubin \< 1.5 x uln * sgot \< 2.5 x uln * sgpt \< 2.5 x uln exclusion criteria: * recent involuntary weight loss (\> 5% of body weight in the past 3 months) * statin therapy - current or planned during study. below is a list of some commonly used statin drugs.(note: this is a helpful guide, not a complete list.) * atorvastatin (lipitor) * cerivastatin * fluvastatin (lescol) * lovastatin (mevacor, altocor, advicor) * mevastatin * pravastatin (pravachol) * rosuvastatin * simvastatin (zocor) * current or planned use of the following medications for fatigue * corticosteroids (intermittent use as part of chemotherapy regimen is allowed) * amphetamines or other stimulants including methylphenidate (ritalin)or modafinil (provigil) * patients diagnosed with uncontrolled hypertension * breast cancer patients who are male * pregnant women are excluded from participation in this study. a serum pregnancy test is required within 1 week of registration if the patient is a woman of childbearing potential. * anticoagulant therapy - current or planned during study (except for maintenance of catheter patency) * patients with uncontrolled thyroid dysfunction

Keywords: fatigue stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer
feasibility trial of the circumferential abdominal pelvic pressure device (capp)

Conditions: Postpartum Hemorrhage

Summary: a group of midwives and obstetric nurses have been trained to use circumferential abdominal pelvic pressure (capp) to treat postpartum hemorrhage. as part of the training follow up any use of a capp device will be monitored to identify complications.

providers will be surveyed twice at 4 and 8 months using open ended methods.

Eligibility criteria:
inclusion criteria: * any patient receiving capp during study period. exclusion criteria: * none (capp is only clinically indicated for obstetric hemorrhage post delivery.
comparison of local anesthetic infusion pump versus depofoam bupivacaine for pain management

Conditions: Pain

Summary: the purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (tram) flap for breast reconstruction. the investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (depofoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. these drugs and devices are approved by the fda (food and drug administration) for the purpose of pain control after surgery, and have been used for this purpose before.

the purpose of this study is to identify the best pain management for patients undergoing abdominoplasty after massive weight loss or transverse rectus abdominis myocutaneous (tram) flap for breast reconstruction. the investigator is conducting this study to compare the effectiveness of a continuous infusion pain pump versus a locally injectable long-acting anesthesia (depofoam bupivacaine) versus standard injectable anesthesia (bupivacaine) for post surgical pain control. these drugs and devices are approved by the fda (food and drug administration) for the purpose of pain control after surgery, and have been used for this purpose before.

Eligibility criteria:
inclusion criteria: * undergoing abdominoplasty or tram flap breast reconstruction exclusion criteria: * a medical condition that could interfere with study participation * body weight less than 50 kg * participating in another study involving an investigational medication

Keywords: tummy tuck (abdominoplasty) breast surgery
comparative clinical study evaluating the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in cancer patients

Conditions: Oncology

Summary: this study aims to investigate the possible efficacy of duloxetine, gabapentin and lacosamide on oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancer.

this is a randomized, double-blind,controlled, parallel study that will be conducted on patients with oxaliplatin induced peripheral neuropathy with gastrointestinal cancer. this study will be done on 93 patients with gastrointestinal cancer (colon or gastric or pancreatic) cancer on standard folfox-4 regimen who will divided into 3 groups: group 1: 31 patients who will receive standard chemotherapy plus duloxetine 30 mg/day for 12 cycles (up to 6 months). group 2: 31 patients who will receive standard chemotherapy plus gabapentin 300 mg/day for 12 cycles (up to 6 months). group 3: 31 patients who will receive standard chemotherapy plus lacosamide 50 mg/day for 12 cycles (up to 6 months).

Eligibility criteria:
inclusion criteria: * a) adults ≥ 18 years old male and female patients. b) patients with gastrointestinal cancer receiving oxaliplatin chemotherapy exclusion criteria: * a) preexisting neuropathic or brain disorders. b) previous use of chemotherapeutic agents including taxanes, platinum, vinca alkaloids, and bortezomib. c) concomitant use of drugs reported to have neuroprotective role and analgesics. d) patients with diabetes, uncontrolled hypertension, congestive heart failure, drug addiction and patients who were receiving tamoxifen. e) patients with abnormal renal function tests (serum creatinine ≤ 30 ml/min) or liver function tests (≥ 3 times the upper normal range). f) participants with a documented medical history of neuropathy. g) concomitant use of other antidepressants, anticonvulsants, high-dose vitamin supplements or drugs known to influence serotonin levels. h) pregnancy and lactating women. i) uncooperative patients and patients who have psychological problems or on antipsychotic medications.

Keywords: oxaliplatin,peripheral neuropathy
performance of eos imaging system in the assessment of spondyloarthritis structural changes compared with standard radiography

Conditions: Spondyloarthritis

Summary: spondyloarthritis is a chronic rheumatic disease that requires prolonged radiographic follow-up. this repetitive exposure to ionizing radiation puts at risk the radiosensitive organs exposed in the field of irradiation. a new low-dose imaging system has emerged. this technique, called eos, offers the advantage of lower irradiation associated with high images quality. our goal through this work was to evaluate the reliability of the eos imaging system compared to conventional radiography in the evaluation of the structural damage of spa.

spondyloarthritis (spa) is a chronic inflammatory disease that can affect the sacroiliac joints, the spine and / or the peripheral joints. it is characterized by a progressive and slow evolution over several years with a risk of ankylosis of the spine. it requires long-term follow-up of patients with repeated x-rays to assess structural damage. this repeated and cumulative exposure to radiation ionization puts at risk the radiosensitive organs that are in the field of irradiation. eos is a new low dose x-ray system that significantly reduces x-ray doses compared to conventional radiography. this system allows the global assessment of the entire skeleton from head to toe, static spine and lower limbs with the obtaining of two-dimensional images of high quality with the possibility of a three-dimensional reconstruction. although the benefits of the eos system are promising with regard to radiation dose reduction, few studies have investigated its use in spa and little evidence has supported its reliability in assessing the structural damage caused by the disease.

Eligibility criteria:
inclusion criteria: * patients with spondyloarthritis (spa) meeting the criteria of amor and / or assessement of spondyloarthritis international society (asas) * indication of standard radiography for the follow-up of the patients. exclusion criteria: * the presence of a contraindication to the performance of conventional radiography (cr) or eos imaging * any disease affecting cognition * patients who have had surgery on the spine and / or hip.

Keywords: spondyloarthritis spine syndesmophyte radiography eos
evaluation of white spot lesion development using 3 orthodontic adhesive systems

Conditions: White Spot Lesion

Summary: the gaol of this randomized clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of white spot lesions (wsls) during fixed orthodontic therapy in comparison with the conventional 3 step bonding system. all participants will be bonded with similar fixed orthodontic appliances using each type of adhesives for the assigned group. wsls will be monitored during the orthodontic treatment

objectives: the objective of this clinical trial was to compare the effect of self-etching primer bonding system and one step adhesive bonding system on the development of wsls during fixed orthodontic therapy in comparison with the conventional 3 step bonding system. materials and methods: seventy five patients were randomly allocated into 3 groups (group 1, conventional bonding system, n=25; group 2, self-etch primer n=25; group 3, primer mixed with the adhesive composite n=25). quantitative light-induced fluorescence (qlf) was used to quantify wsl parameters. images were captured and then analyzed before treatment; 2 months and 4 months after bond-up. lesion area (pixels), mean fluorescence loss (∆f) and the number of newly developed wsls were compared within and between the 3 groups. the significance level was set at p ≤ 0.05.

Eligibility criteria:
inclusion criteria: * healthy patients from both sexes aged 17 - 25 years * mild-to-moderate crowding (≤5 mm) * optimum oral hygiene * maximum of 3 restored teeth * absence of defective enamel formation in the form of hypocalcification or hypoplasia * no salivary gland diseases. exclusion criteria: * patients with poor oral hygiene * heavily restored teeth * sever crowding * presence of systemic disease that may affect salivary glands or the ability to brush their teeth properly.

Keywords: self-etch primer, one step adhesive
anterior cruciate ligament reconstruction with quadriceps tendon bone autograft

Conditions: Anterior Cruciate Ligament Tear; Anterior Cruciate Ligament Injuries; Anterior Cruciate Ligament Rupture

Summary: anterior cruciate ligament injuries are one of the most common sports knee injuries. their effect on the knee joint can be detrimental with patients experiencing instability and progressive damage of the intraarticular structures. therefore, anterior cruciate ligament reconstruction (aclr) is often indicated. multiple graft option exist, including autograft, allograft and xenograft tissues, with autografts being considered as a first-choice source of reconstructed ligament in most cases. two most common harvested autografts are hamstring tendons (semitendinosus or semitendinosus and gracilis tendons; st or stg) and patellar tendon with two bone blocks (bone - patellar tendon - bone; bptb). however, in the recent literature there is an increasing trend towards use of quadriceps tendon autograft (qt). multiple techniques of harvesting this graft were described, including both partial and complete thickness of the tendon. another issue is whether bone block from the upper pole of the patella is harvested along with the soft tissues (quadriceps tendon bone graft, qtb). the aim of this study is to add to the body of knowledge concerning full-thickness quadriceps tendon-bone autograft (qtb) used in aclr. the primary outcome consists of the international knee documentation committee questionnaire (ikdc), the knee injury and osteoarthritis outcome score (koos) and retear rate.


Eligibility criteria:
inclusion criteria: * symptomatic knee anterior and rotatory instability after acl injury; * primary aclr cases exclusion criteria: * active inflammation of the knee; * revision cases; * additional plc, pcl or pfj injuries (mcl and meniscal lesions are not exclusion criteria); * fractures around the knee
mobile sipoo - telemonitoring with combined with active assistance technology

Conditions: Diabetes Mellitus Type 2; Hypertension

Summary: mobile sipoo is a randomized controlled trial aiming to improve selfcare and outcomes of diabetes and hypertensive patients by introducing a remote patient monitoring system supported with automatic patient decision support. the feedback system is coupled with back-office health coaching.

self-monitored data from blood pressure meters (smbp), glucometers (smbg), scales and pedometers are transferred by mobile phone terminals to a tethered personal health record (phr) integrated with the provider ehr. the phr application includes tools to display of self-monitoring data.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of diabetes or hypertension made at least 6 months prior to inclusion to study. * for hypertensive patients: blood pressure over 140/90 mmhg (systolic and diastolic separately) treated or untreated * diabetes patients: glycohemoglobin a1c over 6.5% but lower that 11% * use of diabetes medication exclusion criteria: * patients who decline to participate * patients specifically excluded by the health centre physician * patients unable to co-operate, expected poor study compliance (it illiterate) or reluctance to perform self monitoring * pregnancy * patients with a life expectance of less than one year * patients with major elective surgery planned within 6 months or patient has had major surgery within last 2 months. * patients with psychiatric disorders (depression), abuse of alcohol or narcotics complicating or disabling participation in the study

Keywords: patient decision support telemonitoring self-management remote patient monitoring active assistance technology selfcare