Kornimate/medical-research-clean huggingface dataset:
perinatal outcomes in nutritionally monitored obese pregnant women

Conditions: Obesity

Summary: the aim of this prospective randomized study is the prevention of excessive weight gain in obese pregnant women. the study will compare perinatal outcomes of obese pregnant women treated in the traditional way to outcomes of nutritionally monitored obese pregnant women and evaluate a preliminary behavioral model applicable to the general practice of obstetrics.

study population and selection: this study will recruit 200 obese pregnant women at 12 to 28 weeks of gestation with a body mass index (bmi) of greater than 29.9 kg/m2. women will be eligible if they are pregnant with a single fetus, and are free of diabetes, hypertension, or chronic kidney disease at recruitment. methodology: the patients will be randomized to either traditional or monitored groups. all participants will be counseled at least once regarding conventional prenatal nutrition guidelines. a more detailed dietary intake protocol would be done with the intervention (monitored) group, which would include being placed on a balanced nutritional intake regimen of 18-24 kcal/kg/day (no less than 2000 calories). each patient will be asked to record in a diary all of the foods she eats during the day, which will be reviewed by the investigator or assignee at each prenatal visit. the patients will be weighed at each prenatal visit with the monitored patients weighed and blinded to their actual weight. data analysis: the two groups will be compared with respect to pregnancy weight gain, proportion of excessive weight gain (greater than 15 pounds), maternal morbidity, intrapartum complications and newborn birthweight. the primary analysis will consist of a two sample t-test comparing the monitored versus non-monitored groups with regard to weight gain at delivery. a secondary analysis using a repeated measures anova will look at weight gain in the two groups from baseline to 6 weeks post partum in order to look at trends over time. tests of mean contrasts will compare differences between the two groups at each time during and post pregnancy relative to baseline. additional analyses will be done to look at other outcomes. in the case of continuous variable outcomes (e.g., gestational weight), a student's t-test will be used. while for categorical outcomes (e.g., macrosomia), the chi square test will be used for the comparison. alpha will be 0.05 for each comparison.

Eligibility criteria:
inclusion criteria: * bmi greater than 29.9 kg/m2 * single fetus exclusion criteria: * diabetes * hypertension or chronic kidney disease

Keywords: perinatal outcomes obesity pregnant women
breathing synchronized pet/ct scans for the detection of malignant lung & liver lesions and assessment of tumor glycolysis

Conditions: Lung Cancer; Non-small Cell Lung Cancer

Summary: in this particular study the physicians want to use a new technique of how they obtain the pet/ct pictures. it is called breath-hold (bh) pet/ct". as the name suggests, they will ask the patient to hold their breath for about 20-30 seconds, and only during that time will they obtain pictures. this is repeated several times. in contrast to the standard pet/ct scan, they expect less "blurring" of the pictures, so that they can see the tumor better and measure the uptake of radioactive sugar in the tumor better and more reliably. basically, this is the difference between taking pictures of a runner as compared to taking pictures of a person standing still. since pet images need to be obtained over several minutes and people can not hold their breath for this extended time, we break the procedure into several cycles of 20-30 seconds (or longer, if possible) and then add all the "frozen" pictures in the end into one. they want to know if bh pet/ct scan measure changes in the cancer during therapy (i.e., from the baseline scan before therapy to the follow up scan at within 4 weeks later).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * patients with early stage biopsy-proven lung cancer or patients with lung or liver metastases from any primary cancer (metastatic disease proven by biopsy, or clearly established clinically and by imaging studies who are being treated with stereotactic body radiotherapy (sbrt)or an ablation will be eligible. * patient has at least one lesion ≥ 1cm in size. * signed informed consent exclusion criteria: * pregnant women are ineligible. * patients who are unable to follow breathing instructions either due to language difficulties or hearing impairment this will be determined either by one of the consenting individuals when they approach the patient to ask for informed consent or prior to acquisition of the clinical pet/ct. * patients who are too ill to hold their breath.

Keywords: lung cancer pet scan ct scan bh-pet scan 09-134
prospective study of cionni ring and in-the-bag iol implantation for subluxated lenses

Conditions: Lens Subluxation

Summary: the purpose of this study is to report the intraoperative performance and postoperative outcomes of the cionni-modified capsule tension ring implantation in eyes with subluxated lenses.

the introduction of endocapsular stabilising devices have significantly improved the management of zonular weakness, allowing for in-the-bag iol implantation. the cionni modified capsule tension ring (m-ctr) has an anterior eyelet that provides for fixation of the capsular bag without violating its integrity. adult and pediatric studies have shown the usefulness of the m-ctr to manage zonular weakness. however, there are very few prospective studies that show the outcomes following implantation of the m-ctr and in-the-bag iol on a longterm basis. therefore, the investigators decided to carry out this study to report the intraoperative performance and postoperative outcomes on a longterm basis following m-ctr and in-the-bag intraocular lens (iol) implantation.

Eligibility criteria:
inclusion criteria: * subluxated lenses * traumatic or non-traumatic etiology exclusion criteria: * dislocated lenses

Keywords: cionni ring in-the-bag iol subluxated lenses intraoperative performance postoperative outcome
evaluation of the safety and efficacy of corneal cross linking for the treatment of myopia.

Conditions: Myopia

Summary: 43 subjects (43 eyes) qualified for participation will undergo the required screening procedures to determine study eligibility. the surgical protocol involves applying riboflavin 0,22% to 0,25 % up to 20 minutes . then, the eyes will be exposed to uva (ultraviolet a) light with the kxl ii system according to the programmed treatment pattern. all use of the kxl ii system will be in accordance with the general instructions in the operator's manual. all subjects will be evaluated at screening, day 3, and 1, 3, 6 ,12 and 24 months after treatment. manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (tms), will be obtained at baseline and at appropriate times after the treatment.


Eligibility criteria:
inclusion criteria: * provide written informed consent * willingness to follow all instructions and comply with schedule for follow up visits * having myopia with manifest refraction spherical equivalent of -1.00 to -2.50 d, with cylindrical component pl to -0.75 d * social security insurance or equivalent exclusion criteria: * sensitivity to the use of the test article(s) * hypersensitivity to local anesthesics * corneal pachymetry that is \< 480 microns * eyes with keratoconus * eyes which are aphakic or with corneal intacs * previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. for example: history of corneal disease (e.g., herpes simplex, recurrent erosion syndrome, corneal dystrophy, refractive keratotomy etc.), clinically significant corneal scarring in the crosslinking treatment zone * pregnancy or lactation * patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing * taking vitamin c (ascorbic acid) supplements within 1 week of the cross-linking treatment. * juridical protection
auricular acupuncture for treatment of preoperative anxiety

Conditions: Anxiety

Summary: in this prospective nonrandomized study the investigators are going to investigate whether auricular acupuncture with indwelling fixed needles is feasible for treatment of preoperative anxiety. patients, scheduled for ambulatory gynecologic surgery, will be asked, if they wish to receive auricular acupuncture (aa) against preoperative anxiety. the patients who will not wish aa, will be asked to take part in questioning (state-trait-anxiety-inventory (stai) questionnaire) and will form the control group. the preoperative anxiety using stai, as well as the duration and quality of sleep on the night before surgery, the incidence of side effects, blood pressure and heart rate will be the outcome measures in this study.


Eligibility criteria:
inclusion criteria: 1. patients with an american society of anaesthesiologists physical status of i to ii scheduled for elective ambulatory gynaecological surgery under standardized general anaesthesia 2. surgery time does not exceed 60 minutes 3. patients without previous opioid and psychotropic medication 4. patients aged between 19 and 55 years, able to fill in the stai questionnaire 5. patients who have given written informed consent exclusion criteria: 1. current psychiatric disease 2. local skin infection at the sites of acupuncture 3. aged \ 55 years 4. failure to follow the standardized schema of general anaesthesia 5. surgery time more than 60 minutes 6. intraoperative complications (bleeding, required blood transfusion more than 6 units of packed cells, cardiovascular instability, required catecholamines) 7. patients who consumed opioid medication at least 6 months before surgery 8. patients who are unable to understand the consent form or to fill in the stai questionnaire
assessment the sexual quality of life in breast cancer patients receiving oncosexology supportive care on proactive versus on-request

Conditions: Breast Cancer

Summary: the study compares the quality of sexual life of breast cancer patients under two types of oncosexology supportive care : personalized supportive care versus on-request. the aim is to improve the quality of sexual life of these patients.

breast cancer and its treatment are responsible for symptoms that can persist over time and affect quality of life. given the improved prognosis for breast cancer, more and more patients are faced with the specific problems of the post-cancer period, and caring for them has become a major health issue. sexual health is a crucial component of well-being and overall quality of life. the study compares the quality of sexual life of breast cancer patients under two types of oncosexology supportive care : personalized supportive care versus on-request. for that, quality of life questionnaires will be completed by patients at inclusion and every 6 months for 2 years.

Eligibility criteria:
inclusion criteria: * woman or man at least 18 years old * diagnosis of infiltrating breast cancer regardless of the biological characteristics of the tumor * standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(adp-ribose) polymerase (parp) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously * patient with sufficient command of the french language to be able to answer the questionnaires * patient having given informed, written and express consent. * affiliation to the french social security system * willingness and ability to comply with scheduled visits, treatment plan and other study procedures exclusion criteria: * patient already taken cared of in oncosexology. the following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments) * metastatic disease * patient under guardianship, curatorship or safeguard of justice

Keywords: quality of sexual life
impact of evolocumab on the antiplatelet effects of ticagrelor and aspirin in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the aim of the present study is to investigate the effects of evolocumab in addition to statin therapy on platelet reactivity in patients with acute coronary syndrome (acs) while on ticagrelor and aspirin treatment.

ticagrelor is a commercially available antiplatelet adenosine diphosphate (adp) antagonists. they exert their antiplatelet effects by binding to p2y12 receptors on the platelet surface. ticagrelor is used in combination with aspirin to prevent and treat thrombosis in patients with acute coronary syndrome, particularly after stent implantation. aspirin has an established role in the treatment of acs and secondary prevention of ischaemic heart disease. aspirin inhibits cyclo-oxygenase (cox) enzymes by irreversible acetylation to block platelet aggregation. evolocumab is a monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (pcsk9). the use of evolocumab significantly reduced the incidence of cardiovascular events compared to statins alone. whether the reduction in cardiovascular events is due to ldl reduction or other mechanisms is currently unclear.

Eligibility criteria:
inclusion criteria: 1. patients were diagnosed as acute coronary disease 2. on therapy with ticagrelor(90mg bid) and aspirin(100mg qd), for at least 5 days. 3. fasting ldl-cholesterol ≥70 mg/dl or a non-high-density lipoprotein cholesterol (hdl-c) of ≥100 mg/dl after ≥4 weeks of optimized stable lipid-lowering therapy with maximally tolerated dose of statin. 4. have not used evolocumab in 30 days. exclusion criteria: 1. on treatment with any oral anticoagulant. 2. on treatment with any antiplatelet agent other than aspirin and ticagrelor in the past 5 days. 3. creatinine clearance \<30 ml/minute. 4. known severe hepatic impairment. 5. history of a serious hypersensitivity reaction to evolocumab 6. hemodynamic instability 7. pregnant and breastfeeding women.

Keywords: evolocumab antiplatelet acute coronary syndrome
mind-body medicine for the improvement of quality of life in adolescents and young adults coping with lymphoma

Conditions: Lymphoma

Summary: this trial studies how well a mind-body intervention works in improving overall quality of life in adolescents and young adults with lymphoma. a meditation based mind-body intervention may help lower distress, depressive symptoms, and anxiety in adolescents and young adults coping with lymphoma.

primary objective: i. examine the feasibility of the mind-body intervention in adolescents and young adults (ayas) with lymphoma. secondary objective: i. establish the initial intervention efficacy regarding psychological distress and cancer symptoms (tertiary objective) relative to an attention control (ac) group. exploratory objective: i. explore mediation (e.g., mindfulness, compassion, social connection, inflammatory processes) and moderation (e.g., demographic and medical factors) of the intervention effects. outline: patients are randomized to 1 of 2 groups. group i: patients attend meditation group sessions over 75 minutes once weekly for up to 5 weeks. group ii: patients attend educational group sessions over 75 minutes once weekly for up to 5 weeks. after completion of study intervention, patients are followed at 6 and 12 weeks.

Eligibility criteria:
inclusion criteria: * participants between the ages of 18-39 diagnosed within 6 months with stage i-iv lymphoma (all types) * eastern cooperative oncology group (ecog) performance status of 2 or below * having access to the internet * able to read, write and speak english exclusion criteria: * major psychiatric or cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team * regular (self-defined) participation in psychotherapy or a formal cancer support group

Keywords: all types of lymphoma
study of growing biofilm by an antiplaque mouthrinse

Conditions: Dental Plaque

Summary: the objective of this study is to evaluate the efficiency of a new mouthrinse on dental plaque deposits. the study is carried out on 50 volunteers that are asked to use the mouthrinse without any other oral hygiene measure, during 4 days. it is a double bind, cross-over, randomized design: the same subjects test the active product and the placebo.

the prevention of oral diseases is mainly targeted at the control of dental plaque. while tooth brushing is an effective method to remove plaque mechanically, it is not always sufficient and chemical antiplaque agents could be helpful. some of them are used for their antibacterial action, the gold standard being chlorhexidine. despite the great benefit of this bactericidal approach, the search continues for active ingredients that could prevent dental plaque formation without affecting the biological equilibrium within the oral cavity. the aim of this study is to evaluate the efficiency of a mouthrinse, containing red grape seed extract and nicométhanol fluorhydrate, in the control of dental plaque deposit in a 4-days plaque regrowth model. the study is a double blind randomized cross-over design, involving 50 healthy volunteers. during the treatment periods (4 days) no oral hygiene, measures excepting rinsing with the allocated product (active/non active) are permitted. on day 1, the subjects receive professional prophylaxis. the mouthrinse is used pure, three times per day, after each meal. on day 5, subjects will be scored for disclosed plaque using the quigley hein index (modified by turesky). after a 2 weeks wash-out period, the subject receives the other product (active/non active) and uses it as in the first period. on day 5, subjects will be scored again for disclosed plaque

Eligibility criteria:
inclusion criteria: * healthy volunteer * without caries * with at least 20 natural teeth excluding third molars * women using contraceptives for at least twelve weeks and while on study * protected by french social security system * written informed consent exclusion criteria: * pregnancy or breast feeding * volunteers with partial denture or orthodontic appliance * person protected by the law who * person unable to give their consent to participate to the study. * under aged * current participation in another clinical trial * oral pathologies * systemic diseases * volunteers allergic to of the componentst of the tested products * volunteers with hyposalivation or xerostomia * treatment with antibiotics o intestinal antiseptics within 3 month before inclusion * treatment with oral antiseptics within 1 month before inclusion * alcoholic consumption more than 20 g/day (or 2 glasses) * heavy smokers * volunteers drinking a lot of tea or coffee

Keywords: mouthrinse grape seed extract fluor plaque index
bal fluid biomarkers in sarcoma

Conditions: Soft Tissue Sarcoma (STS); Bronchoalveolar Lavage (BAL); Bronchoalveolar Lavage Fluid

Summary: this is a single-centre, phase ii, prospective study designed to assess balf and ta-derived biomarkers in relation to metastatic burden in sts patients. balf and ta samples will be collected during routine bronchoscopy performed as part of standard care at toronto general hospital (tgh). additionally, tissue samples of lung metastases and adjacent normal lung will be collected and used to correlate the identified biomarkers.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. ability to understand and willingness to sign a written informed consent document 3. diagnosed with soft tissue sarcoma 4. undergoing resection of lung lesion as part of standard care exclusion criteria: 1. history of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for ≥ 2 years
evaluation of the efficacy of aloe-vera el versus bezydamine hydrochloride in the prevention of radiation induced oral mucositis a randamized controlled clinical trial

Conditions: Head and Neck Cancer Patients Treated With Radiotherapy

Summary: background and rationale oral mucositis (om) is one of the most debilitating toxic side effects of radiotherapy and chemotherapy. \]radiation-induced om occurs due to the generation of free radicals, which induce mitochondrial dysfunction resulting in increased oxidative stress, dna damage and cell apoptosis. epidermal growth factor (egf) levels were decreased in patients with severe om, and patients with lower levels of egf prior to therapy may indicate increased risk of mucosal damage during rt objectives: the purpose of this study is for evaluation of the efficacy of aloe-vera gel versus standard treatment as a new option in the treatment of radiation-induced oral mucositis study population \& sample size : 40 patient proven to have head and neck cancer , requiring radiotherapy. study design: rct. the patients are randomized and divided into 2 groups , group a will use alovera gel , group b will use benzylamide gel, egf will be measured in saliva before and after 4 weeks treatment methods patient's visits will be at baseline, 2 weeks and 4 weeks. at follow up visits patients will be instructed to bring back the consumed container to check that they had totally consumed their previous supply before giving them the new one. saliva collection to measure egf by eliza


Eligibility criteria:
inclusion criteria: * the study will include patients who are diagnosed with radiation-induced oral mucositis with any of its grades as scored by the world health organization (who) oral mucositis grading scale. exclusion criteria: * patients under the age of 18 ,patients receiving any previous treatment for oral mucositis during the last 2 weeks, allergy to aloe-vera, patients with chronic liver disease, infectious diseases (hiv, hbv,hcv,....), immune system dysfunction, haematological diseases and pregnancy or breast-feeding
an efficacy study of exercise rehabilitation on pain and disability for patients with non-specific low back pain

Conditions: Low Back Pain, Mechanical

Summary: the primary objective of this study is to compare the efficacy of two different exercise programs for the reduction of pain and disability in a specific subgroup of nslbp patients and aims to investigate the additive effect of hip stabilization exercises. the investigators hypothesize that the combined local (segmental) stabilizer and hip stabilizer program (t2) will be more effective in reducing pain and disability in nslbp patients compared to the local (segmental) stabilizer program (t1).

the secondary objective of this study is to measure the changes in lumbopelvic and hip mechanics for both treatment groups following completion of the exercise programs. we hypothesize that there will be differences observed between groups following the 6wk rehabilitation programs, and that only the group completing the combined local (segmental) stabilizer and hip stabilizer strengthening program (t2) will demonstrate significant differences in mechanics compared to baseline testing.

Eligibility criteria:
inclusion criteria: * 18-65 years old * unilateral or bilateral nslbp symptoms for a minimum of 6 weeks * current symptoms rated at least a 5/10 on a scaled from 0-10 exclusion criteria: * symptoms 'red flags' for underlying pathological conditions such as bowel and/or bladder problems, radicular symptoms, night pain * scoliosis * neurological impairment, discogenic pathology, vestibular disorder * pregnancy or within 1 year of giving birth * previous or ongoing complications from lower extremity injury or surgery in the past year * previous surgery to the lumbar spine or hip * use of any radiological interventions or injections such as prolotherapy, corticosteroid, or nerve block in the past 3 months

Keywords: home based daily exercise program local lumbopelvic stabilizer muscles hip stabilizer muscles real time ultrasound imaging