Kornimate/medical-research-clean huggingface dataset:
intravitreal bevacizumab for neovascular glaucoma

Conditions: Neovascular; Glaucoma

Summary: several studies have confirmed high levels of vascular endothelial growth factor (vegf) in eyes with neovascular glaucoma (nvg). the role of vegf inhibitors in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic macular edema has been described. we aim to evaluate the effect of three intravitreal injections of bevacizumab (avastin) 2.5 mg versus a sham procedure for treatment of nvg. outcome measures include intraocular pressure and extent of iris neovascularization. both study arms will receive conventional treatment for nvg.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of nvg * vision less than 20/200 * age 10-80 years exclusion criteria: * uncontrolled blood pressure * history of thromboembolism * congestive heart failure * renal failure * pregnancy or lactation * active ocular or periocular infection * no light perception

Keywords: neovascular glaucoma bevacizumab avastin intravitreal iop
stem cell educator therapy in diabetes

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: stem cell educator (sce) therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent cord blood stem cells (cb-scs) in vitro, and returns only the "educated" autologous immune cells to the patient's circulation. several mechanistic studies with clinical samples and animal models have demonstrated the proof of concept and clinical safety of sce therapy. they suggest sce therapy may function via cb-sc induction of immune tolerance in the autoimmune t cells and pathogenic monocytes/macrophages when these are exposed to the autoimmune regulator protein (aire) in the cb-scs. in this project, the optimized sce therapy for type 1 diabetes (t1d) and t2d will be tested in a prospective, single-arm, open-label, single-center study to assess its clinical efficacy and related molecular mechanisms in patients with diabetes.


Eligibility criteria:
inclusion criteria: * patients are screened for enrollment in the study if both clinical signs and laboratory tests meet the diagnosis standards of american diabetes association. exclusion criteria: * exclusion criteria are any clinically significant diseases in liver, kidney, and heart. additional exclusion criteria are no pregnancy, no immunosuppressive medication, no viral diseases or diseases associated with immunodeficiency.

Keywords: stem cell educator immune modulation diabetes autoimmune insulin resistance pancreatic islets
ultra-hypofractionated for whole breast irradiation (wbi) compared to partial breast irradiation (pbi)

Conditions: Breast Cancer Female

Summary: female patients undergoing surgical treatment for early breast cancer and meeting the inclusion criteria for adjuvant breast radiotherapy were randomized into two groups. one group will receive adjuvant whole-breast radiotherapy in ultra-hypofractionated regimen of 26 gy in 5 fractions. in contrast, the other group will receive partial breast irradiation with a dose of 26gy in 5 fractions. the study's objective is to compare the effects of both breast radiotherapy protocols in terms of locoregional disease control and survival and to compare the adverse effects of radiotherapy between the two protocols. to determine if there is a correlation between different parameters and the efficacy and degree of toxicity for both protocols.

radiation therapy should ideally start 6-8 weeks after breast-conserving surgery but no later than 12 weeks after the surgery. if adjuvant chemotherapy has been administered, it is recommended to start radiation therapy three weeks after chemotherapy (optionally, it can be completed before beginning chemotherapy). the radiation therapy procedure follows the existing clinical protocol for breast radiotherapy. for radiation therapy planning, the patient is positioned supine using immobilization devices (such as a wing board or similar) to ensure daily reproducibility within a range of 5 mm. the clinical target volume (ctv) is delineated according to the recommendations of the danish breast cancer cooperative group (dbcg) and the european society for radiotherapy and oncology (estro). a total dose of 26gy in 5 fractions every working day using the volumetric modulated arc therapy (vmat) technique. daily portal images are obtained, and a breathing control protocol is applied based on clinical assessment (for left breast radiation therapy, active breath control is used - in deep inspiration or respiratory gating).

Eligibility criteria:
inclusion criteria: * breast-conserving surgery * invasive ductal carcinoma * age ≥ 50 * tumor size ≤ 3 cm * r0 resection * unicentric/unifocal carcinoma or multifocal carcinoma within 2 cm of the primary neoplasm * pn0 (sentinel lymph node biopsy or axillary lymph node dissection performed), n1mi * hormone receptor status - any * histological grade g1 or g2 exclusion criteria: * neoadjuvant systemic therapy * tnbc (triple-negative breast cancer) * extensive intraductal component (eic) * lymphovascular invasion (lvi) * associated dcis \> 2.5 cm in size or high nuclear grade

Keywords: ultra-hypofractionated radiotherapy partial breast irradiation breast radiotherapy toxicity
prospective evaluation of clinical and radiographic outcomes following total talus replacement (proclaim)

Conditions: Avascular Necrosis of the Talus; Talar Osteochondral Defect of Ankle; Talar Dysfunction

Summary: this is a humanitarian device exemption (hde) approved device. the purpose of this study is to evaluate the continued safety and probable benefit of the restor3d total talus replacement device in commercial use.


Eligibility criteria:
inclusion criteria: * ≥22 years of age * scheduled to receive ttr implant for one of the following indications: * avascular necrosis of the talus * avascular necrosis of the talus in addition to talar collapse, cysts or non-union * large, uncontained, unstable, or cystic talar osteochondral defects with risk of collapse or talar osteochondral defects not responsive to traditional treatments * nonunion following talar fracture or talar extrusion, unresponsive to more conservative treatments * have not had a prior total talus replacement device implanted * not planning to receive bilateral total talus replacement devices * subject signs a written informed consent form (icf) prior to the surgical procedure exclusion criteria: * surgical procedures other than those listed in the indications for use. * use of implant greater than 6 months from date of patient's preoperative ct scan. * degenerative changes in the tibiotalar, subtalar or talonavicular joints. * gross deformity in sagittal or coronal planes. more than 15 degrees of varus or valgus deformity in the coronal plane, or more than 50% subluxation anteriorly or posteriorly of the talus in the sagittal plane * patients with an active local or systemic infection. * osteonecrosis of the calcaneus, distal tibia or navicular. * known history of existing malignancy, or any systemic infection, local infection, or skin compromise at the surgical site. * blood supply limitations and previous infections that may prevent healing. * physical conditions that would eliminate adequate implant support or prevent healing, including inadequate soft tissue coverage. * conditions which may limit the patient's ability or willingness to restrict activities or follow directions postoperatively during the healing period. * presence of neurological deficit which would prevent patient postoperative compliance. * patients with foreign body sensitivity, suspected or documented material allergy or intolerance. where material sensitivity is suspected, appropriate tests should be conducted, and sensitivity ruled out prior to implantation.

Keywords: avascular necrosis talus ankle joint
a study of pro95780 in patients with previously untreated, advanced-stage non-small cell lung cancer (apm4074g)

Conditions: Non-Small Cell Lung Cancer

Summary: this is a randomized, double-blind, phase ii, placebo-controlled trial adding on to a background of effective treatment designed to evaluate the efficacy, safety, and pharmacokinetics of pro95780 combined with paclitaxel + carboplatin + bevacizumab therapy in patients with previously untreated stage iiib, stage iv, or recurrent non-small cell lung cancer (nsclc). approximately 120 patients will be randomized to one of two treatment arms.


Eligibility criteria:
inclusion criteria: * ability to understand and willingness to sign a written informed consent * histologically or cytologically confirmed nsclc * advanced nsclc * measurable disease * ecog performance status of 0 or 1 * age ≥ 18 years * use of accepted and effective method of contraception, i.e., double barrier contraceptive methods (e.g., diaphragm plus condom) or abstinence during the course of the study and for 6 months after the last study treatment administration for women, and 1 month for men exclusion criteria: * squamous cell histology * prior malignancy other than nsclc (except in situ basal cell carcinoma or in situ cervical cancer), unless it has been treated with curative intent and there is no evidence of disease for ≥ 3 years prior to randomization * untreated or unstable cns metastases * myocardial infarction or an unstable or uncontrolled disease or condition related to or impacting cardiac function within 1 year prior to randomization * uncontrolled hypertension * history of arterial thrombosis, stroke, or serious hemorrhagic disorder within 1 year prior to randomization * major surgical procedure within 28 days prior to randomization * serious non-healing wound ulcer, or bone fracture within 21 days prior to randomization * persistent history of gross hemoptysis relating to the patient's nsclc * known hiv infection * known to be positive for hepatitis c or hepatitis b surface antigen * chronic daily treatment with aspirin or nonsteroidal anti-inflammatory agents known to inhibit platelet function * use of anticoagulation therapy * participation in clinical trials or undergoing other investigational procedures within 30 days prior to randomization * pregnancy (e.g., positive hcg test) or breast feeding * known sensitivity to any of the products to be administered during the study * any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures

Keywords: nsclc cancer avastin apm4074g
the diastolic pressure gradient for patients with acute coronary syndrome: evaluation of non culprit lesions

Conditions: Functional Evaluation of Non Culprit Lesions in ACS Patients

Summary: the assessment of non-culprit stenoses is an important issue in acs. adenosine administration is currently required for functional evaluation of stenosis severity using the fractional flow reserve (ffr). an alternative adenosine-independent index of coronary stenosis, the instantaneous wave-free ratio (ifr), was recently introduced. aim of the present study will be to evaluate the trans-stenotic instantaneous wave-free pressure gradient (ifg), the instantaneous wave-free ratio (ifr) and the fractional flow reserve (ffr) in acs patients.


Eligibility criteria:
inclusion criteria: * age 40 to 80 years * recent acute coronary syndrome * indication for coronary angiography * presence of at least one non-culprit lesion requiring functional evaluation with fractional flow reserve (ffr): exclusion criteria: * haemodynamically significant valvular disease * controindication for adenosin administration * previous cabg on the index vessel
effect of desipramine on upper airway collapsibility and genioglossus muscle activity in patients with obstructive sleep apnea - study b

Conditions: Sleep Apnea, Obstructive

Summary: obstructive sleep apnea (osa) is common and has major health implications but treatment options are limited. osa patients show a marked reduction in upper airway (ua) dilator muscle activity at sleep onset and this phenomenon leads to increased collapsibility of ua compared to normal participants. until recently, the search for medicines to activate pharyngeal muscles in sleeping humans has been discouraging. however, exciting new animal research has shown that drugs with noradrenergic and antimuscarinic effects can restore pharyngeal muscle activity to waking levels. in this protocol the investigators will test the effect of desipramine (a tricyclic antidepressant with strong noradrenergic and antimuscarinic effects) on upper airway collapsibility and genioglossus muscle activity (emg gg) during sleep in osa patients.

two overnight sleep studies, a placebo night and a drug night, will be performed approximately one week apart in random order. the placebo or drug will be administered 2 hours before lights out. at least 15 minutes of quiet wakefulness will be recorded to quantify the participant's emg gg activity while awake and at sleep onset (alpha-theta transition at the electroencephalogram). during the second part of the night, the participants will be connected to a modified continuous positive airway pressure (cpap) machine (pcrit3000, respironics) which can provide a wide range of pressures between 20 and -20 cmh2o in order to modify upper airway pressure and measure pharyngeal critical collapsing pressure (pcrit), ventilation at 0 cmh2o when ua muscle are passive and active as well as change in emg gg as a function of epiglottic pressure (muscle responsiveness). apnea-hypopnea index (ahi) will be calculated in each night from the part of the study off cpap.

Eligibility criteria:
inclusion criteria: * diagnosed osa (moderate-to-severe; apnea hypopnea index \>15 events/hr) exclusion criteria: * cardiovascular disease other than well controlled hypertension * depression
protein supplementation and exercise in patients with fsh muscular dystrophy- a randomized placebo controlled study

Conditions: Facioscapulohumeral Muscle Dystrophy

Summary: the hypotheses is that regular post exercise supplementation increase fitness and daily activity level in patients with fascioscapulohumeral (fsh) muscular dystrophy. all patients are tested before and after 12 weeks of cycle-ergometer exercise. maximal oxygen consumption and 6mwt is used as primarily effect goals. secondary effect goals are risk of falls and daily activity level.

the purpose of this study is to investigate the response to protein-carbohydrate supplementation doing regular exercise in patients with fshd. all patients are tested before and after 12 weeks of cycle-ergometer exercise. maximal oxygen consumption and a functional 6 min walk test(6mwt) is used as primarily effect goals. secondary effect goals are risk of falls and daily activity level. we measure manuel muscle strength, a balance test, a 5-time-up-and-down-chair-test, a 14 steps-stair-test, accelerometer measuring, daily activity level questionnaire and sp36. we use a blinded randomized controlled trail. the interventions are 12 weeks regular exercise and consumption of a post-exercise drink. the exercise consists of 30 session of 30 minutes moderate exercise on a cycle-ergometer. after each exercise session patients consume a protein or a non-caloric placebo drink.

Eligibility criteria:
inclusion criteria: * verified fshd * age 18-65 * untrained. less than two hours cardio-training each week the last 4 month. exclusion criteria: * competitive disorders * pregnant and breastfeeding * unable to walk 200 m within 6 min.

Keywords: fshd endurance exercise protein supplementation placebo rct
sense of coherence and primary dysmenorrhea in high school girls in finistere, france

Conditions: Primary Dysmenorrhea

Summary: this study evaluates the relation between sens of coherence and primary dysmenorrhea. aself-questionnaire is completed by a sample of girls aged between 14 and 19, schooled in finistère (france).

primary dysmenorrhea affects more than 60% of adolescent girls. menstrual pain increases absenteeism and lowers self-esteem and academic performance. moreover, dysmenorrheal women suffer more depression and anxiety. sense of coherence (soc) is composed of three items: * comprehensibility: what the person understands about his illness * manageability: what the person does to cope * meaningfulness: what the disease means to the person. a high soc score is related to good mental and physical health. the aim of this study will be to determine if there is a relationship between primary dysmenorrhea and the sense of coherence. a self-questionnaire composed of the soc-13 and a scale evaluating dysmenorrhea will be proposed in the voluntary high schools of finistère (france) to the girls of the classes chosen at random.

Eligibility criteria:
inclusion criteria: * student in high schools * aged 14 and 19 years * with menstrual cycle exclusion criteria: * illiteracy * student and parents opposition

Keywords: sens of coherence primary dysmenorrhea salutogenesis teenagers
development of a new method for liver stiffness measurement using fibroscan

Conditions: Liver Diseases

Summary: this is an european, prospective, interventional, multicenter clinical investigation that will take place in 2 french sites. 114 adults patients will be included. the study objective is to develop a new method for measuring liver stiffness using fibroscan.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years of age) followed in the hepatology or endocrinology department for liver disease, suspected liver disease or consequences of liver disease, all etiologies combined. * adult patient able to give his written consent * patient affiliated to the french social security system exclusion criteria: * vulnerable patients * patients with liver ascites * patients with heart failure

Keywords: fibroscan vibration controlled transient elastography liver stiffness measurement
comparison of a dtap-ipv-hb-prp~t combined vaccine to infanrix™-hexa, when administered with prevnar® in thai infants

Conditions: Hepatitis B; Polio; Diphtheria; Pertussis; Haemophilus Influenzae Type b

Summary: the purpose of the study is to provide immunogenicity and safety data of the investigational hexavalent vaccine when it is given concomitantly (the same day at separate injection sites) with prevnar, according to the 2-4-6 month immunization schedule, following one dose of hb vaccine at birth. primary objective: to demonstrate that the hexavalent dtap-ipv-hb-prp\~t combined vaccine induces an immune response that is at least as good as the response following infanrix™-hexa in terms of seroprotection rates to hb and prp, one month after a 3 dose primary series (2, 4, and 6 months), when co-administered with prevnar® secondary objectives: immunogenicity: to describe in each group the immunogenicity parameters to each vaccine component (for dtap-ipv-hb-prp\~t and infanrix™-hexa) one month after the third dose of the primary series. safety: to describe the overall safety after each injection.


Eligibility criteria:
inclusion criteria : * two month old infant (50 to 71 days old) on the day of inclusion, of either gender. * born at full term of pregnancy (\>= 37 weeks) and with a birth weight \>= 2.5 kg. * hepatitis b vaccination since birth. * informed consent form signed by one parent/legally acceptable representative and an independent witness if the parent/legally acceptable representative is illiterate. * able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria : * participation in another clinical trial in the 4 weeks preceding the first trial vaccination. * planned participation in another clinical trial during the present trial period. * systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances. * congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid therapy. * chronic illness at a stage that could interfere with trial conduct or completion. * blood or blood-derived products received since birth. * any vaccination in the 4 weeks preceding the first trial vaccination. * any planned vaccination (except trial vaccinations) during the trial. * documented history of pertussis, t, d, polio, hib, hepatitis b or streptococcus pneumoniae infection(s) (confirmed either clinically, serologically, or microbiologically). * previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, haemophilus influenzae type b infection(s) or streptococcus pneumoniae. * known personal or maternal history of hiv, hb (hbsag carrier) or hepatitis c seropositivity. * known thrombocytopenia or bleeding disorder contraindicating im vaccination. * history of seizures. * febrile (rectal equivalent temperature \>= 38.0°c) or acute illness on the day of inclusion.

Keywords: hepatitis b polio diphtheria pertussis h. influenzae type b
exercise: a novel treatment for combat post traumatic stress disorder

Conditions: Post-Traumatic Stress Disorder

Summary: the primary objective of this pilot intervention study is to examine the efficacy of exercise for reducing the symptoms of posttraumatic stress disorder (ptsd) and other psychiatric and somatic symptoms. the sample will be composed of veterans aged 18-65 with combat-related ptsd (n = 40). participants will be randomly assigned to one of two groups. participants in the exercise training group (n = 20) will receive three 60-75 minute sessions per week of combination aerobic and resistance training for eight weeks. in the control stretching group, participants (n = 20) will receive training in whole-body flexibility three times per week for eight weeks. secondary objectives include 1) determining feasibility of the intervention (as measured by the percentage of prescribed days of exercise completed by each participant, and percentage of time exercising completed at the prescribed intensity and duration); 2) determining the influence of exercise training on aerobic fitness and strength in the sample; and 3) determining whether psychiatric/somatic symptom improvements are associated with improvements in fitness and strength. finally, exploratory objectives will include examining whether exercise training can improve early signs of heart disease, and whether certain biomarkers (using mri and fmri data and inflammatory markers) are associated with treatment response.


Eligibility criteria:
inclusion criteria: 1. ages 18-65yr 2. diagnosis of ptsd 3. caps \>30 4. reported combat exposure per the deployment risk and resilience inventory (drri) 5. sedentary lifestyle (planned activity for purpose of health \< 2 days/wk) 6. capability of giving informed consent exclusion criteria: 1. abuse of alcohol or drugs 2. homelessness 3. significant cognitive impairment (e.g., mmse score of ≤ 26) that would hinder ability to understand the protocol 4. signs or symptoms of cardiovascular, metabolic or pulmonary disease that would preclude participating in the exercise, including uncontrolled hypertension (\> 159/99 mm hg) 5. usage of beta blockers, which could influence the heart rate response to exercise 6. any physical or mental health condition that would contraindicate participation in the study (e.g., musculoskeletal, orthopedic, and/or neuromuscular disorders) 7. high suicidality 8. below cutoff on either stai (\<30) or pcl-m (\<40) 9. pregnancy or plans to become pregnant in the next 4 months 10. excessive levels of physical activity assessed via interview and pedometer recording 11. current treatment for ptsd (drug or counseling) for a duration of less than eight weeks 12. clinically judged to be unsuitable for participation by the research physician

Keywords: combat disorders exercise therapy