Kornimate/medical-research-clean huggingface dataset:
thromboprophylaxis in pregnant women in hospital: a prospective clinical trial

Conditions: Thrombophilia Associated With Pregnancy; Perioperative/Postoperative Complications; Venous Thrombosis; Pulmonary Embolism; Other Specified Risk Factors in Pregnancy; Deep Vein Thrombosis

Summary: hospitalization in pregnancy and childbirth greatly increases the thromboembolic risk of these patients. the application of a protocol for assessing the risk of vte reduces mortality and morbidity of these phenomena.

thromboembolic events are among the leading causes of maternal morbidity and mortality in pregnancy / postpartum period. they are the leading cause of maternal death in developed countries. risk factors for venous thromboembolism (vte) during pregnancy and postpartum as family history or personal history of vte, thrombophilia, age over 35, obesity and high parity has been the most studied. one of the main risk factors is hospitalization, which increases up to 20 times the risk of vte. objective: the objective of the study is to identify early risk factors for vte in hospitalized pregnant women and institute appropriate prophylaxis to reduce the incidence and morbidity. methods: a prospective study that will evaluate all pregnant women admitted for clinical treatment and / or surgery in the department of obstetrics and gynecology, clinics hospital, university of são paulo through the application of a thromboprophylaxis protocol with risk assessment score. the patient in whom prophylaxis would be indicated are those with scores greater than or equal to 3. the drug to be used is enoxaparin and the dose to be used depends on the weight of the patient. it will be further assessed: adverse effects of treatment with enoxaparin, protocol failure in the group treated and untreated (without anticoagulation) and bleeding incidence in the untreated group. risk score description: score 3 - previous thrombosis/thromboembolism, homozygous mutations, combined thrombophilia risk factors, antiphospholipid syndrome, cancer(stomach, pancreas, lung), inflammatory conditions, lupus, sickle cell disease, nephrotic syndrome, heart disease; score 2 - protein c deficiency, protein s deficiency, heterozygous f5 leiden, heterozygous f2 g20210a mutation, cancer(last 6 months), chemotherapy(last 6m), immobility, bed rest \>4d prior to c-section, current serious infections, bmi≥40 kg/m2 , age≥40y, lung disease(cyanosis), postpartum hemorrhage \>1l; score 1 - age ≥ 35 and ≤39 y, parity ≥3, multiple pregnancy, hyperemesis, gross varicose veins, smoker ≥20, surgical procedure.

Eligibility criteria:
inclusion criteria: * all pregnant women hospitalized. exclusion criteria: * previous use of anticoagulation

Keywords: thrombophilia thrombosis pregnancy, high-risk venous thrombosis enoxaparin risk assessment deep vein thrombosis pulmonary embolism hospitalization
development of an ergonomic wheelchair pushrim

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to test the effectiveness of newly designed ergonomic manual wheelchair handrims called the natural-fit and palmrim when compared to a new standard handrim. it is our hope that the new design of the handrims will help reduce upper extremity pain and injury, which is very common among manual wheelchair users. the natural-fit handrim was designed to directly address the shortcomings of standard handrims and to improve the standard-round tube handrims which were designed over 50 years ago. the palmrim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.

this research will have three parts. the first part will include completing propulsion and braking tasks with the subject's original handrims. after the initial testing, new handrims (naturalfit, palmrim, and a new standard handrim) will be installed on the subject's wheelchair and subjects will again be asked to complete another set of propulsion and braking tasks. subjects will also be asked to complete a questionnaire to assess wrist and shoulder pain and undergo an examination of the condition of the palm of their hand. for the second part of the study, subjects will be asked to participate in a 4-month trial use period of the new handrims on their wheelchair. in the third part of the study, subjects will complete the final set of propulsion and braking tasks and complete a follow-up questionnaire.

Eligibility criteria:
natural-fit inclusion criteria: * use of a manual wheelchair as a primary means of mobility (over 40 hours per week) * use a standard handrim * between the ages of 18 and 55 * has normal hand function exclusion criteria: * pressure sores palmrim inclusion criteria: * use of a manual wheelchair as a primary means of mobility (over 40 hours per week) * use a vinyl-coated handrim * between ages 18 and 55 * has impaired hand function exclusion criteria: * pressure sores

Keywords: wheelchair handrims rehabilitation upper extremity
controlling myopia progression with soft contact lenses

Conditions: Myopia

Summary: this study is to investigate whether novel soft contact lens optical designs can slow myopia progression.


Eligibility criteria:
inclusion criteria: 1. the subject must be between 8 and 12 years of age and of asia origin. 2. the subject's best sphere contact lens correction must lie between -0.75d (best of the two eyes) and -5.00d (worst of the two eyes) 3. astigmatism must be less than or equal to 1.00d 4. less than 1.00d difference in spherical equivalent between the two eyes 5. the subject must have a best-corrected visual acuity of 20/25 and spherical equivalent refraction visual acuity of 20/25 or better in both eyes 6. the subject must have at least 8d of accommodation. 7. the subject's parent or legal guardian must read and sign the statement of informed consent and the subject must read and sign the child's assent form and be provided a copy of each form 8. the subject must appear able and willing to adhere to the instructions set forth in the clinical protocol exclusion criteria: 1. ocular or systemic allergies or diseases that may interfere with contact lens wear 2. systemic disease or autoimmune disease or use of medication (e.g. antihistamines), which may interfere with contact lens wear. 3. clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection that might interfere with contact lens wear. 4. clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormality of the cornea, which may contraindicate contact lens wear. 5. any ocular infection. 6. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. any infectious disease (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. hiv). 8. diabetes. 9. anismetropia. 10. astigmatism of greater than 1.00d in either eye. 11. eye injury or eye surgery within eight weeks immediately prior to enrollment for this study. 12. previous refractive surgery, rigid contact lens wear, orthokeratology, keratoconus, or other corneal irregularity in either eye 13. strabismus in either eye 14. pupil or lid abnormality or infection in either eye 15. central corneal scar and aphakia in either eye 16. contraindications to contact lens wear such as dry eye or history of prior unsuccessful contact lens wear 17. history of participation in clinical trials aimed to control myopia progression 18. surgically altered eyes, ocular infection of any type, ocular inflammation 19. subject has anterior chamber angle grade 2 or narrower
treosulfan based conditioning acute myeloid leukaemia (aml)

Conditions: Acute Myeloid Leukaemia

Summary: this is a multicenter, multinational, non-randomized, non-controlled open-label phase ii trial to evaluate the safety and efficacy of treosulfan in a combination regimen with fludarabine as conditioning therapy prior to allogeneic stem cell transplantation (sct) in patients with aml. the aim is to demonstrate a clinical benefit compared with historical data on intravenous busulfan (busulfextm, busilvextm), the only drug so far registered in the indication conditioning before allogeneic stem cell transplantation.


Eligibility criteria:
inclusion criteria: * patients with acute myeloid leukaemia (aml) according to who classification (\> 20% myeloblasts in peripheral blood or bone marrow at initial diagnosis) with \< 5% myeloblast in the bone marrow, indicated for allogeneic transplantation * availability of an hla-identical sibling donor (mrd) or hla-identical unrelated donor (mud) hla-identity defined by the following markers: a, b, drb1, dqb1. * target graft size (unmanipulated) * bone marrow: 2 - 10 x 106 cd34+ cells/kg bw recipient or \> 2 x 108 nucleated cells/kg bw recipient or * peripheral blood: 4 - 10 x 106 cd34+ cells/kg bw recipient * age \> 18 and \< 60 years * karnofsky index \> 80 % * adequate contraception in female patients of child-bearing potential * written informed consent exclusion criteria: * therapy related secondary aml * aml with t(8;21)(q22;q22) in cr1 * acute promyelocytic leukaemia with t(15;17)(q22;q12) in cr1 * secondary malignancies * previous allogeneic transplantation * severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function) * known and manifested malignant involvement of the cns * active infectious disease * hiv- positivity or active hepatitis infection * impaired liver function (bilirubin \> upper normal limit; transaminases \> 3.0 x upper normal limit) * impaired renal function (creatinine-clearance \ 1.5 x upper normal limit). * pleural effusion or ascites \> 1.0 l * pregnancy or lactation * known hypersensitivity to treosulfan and/or fludarabine * participation in another experimental drug trial within 4 weeks before day -6 * non-co-operative behaviour or non-compliance * psychiatric diseases or conditions that might impair the ability to give informed consent

Keywords: treosulfan fludarabine atg aml
aerobic interval and moderate continuous exercise training on ventricular functions

Conditions: Healthy; High Intensity Interval Training; Exercise Training

Summary: hypoxic exposure increases right ventricular (rv) afterload by triggering pulmonary hypertension, with consequent effects on the structure and function of the rv. improved myocardial contractility is a critical circulatory adaptation to exercise training. however, the types of exercise that enhance right cardiac mechanics during hypoxic stress have not yet been identified. this study investigated how high-intensity interval training (hiit) and moderate-intensity continuous training (mict) influence right cardiac mechanics during hypoxic exercise (he).

hypoxic exposure increases right ventricular (rv) afterload by triggering pulmonary hypertension, with consequent effects on the structure and function of the rv. improved myocardial contractility is a critical circulatory adaptation to exercise training. however, the types of exercise that enhance right cardiac mechanics during hypoxic stress have not yet been identified. this study investigated how high-intensity interval training (hiit) and moderate-intensity continuous training (mict) influence right cardiac mechanics during hypoxic exercise (he). the young and healthy sedentary males were randomly selected to engage in either hiit (3-min intervals at 40% and 80% of vo2 oxygen uptake reserve) or mict (sustained 60% of vo2 oxygen uptake reserve) for 30 min/day and 5 days/week for 6 weeks or were included in a control group (ctl) that did not engage in any exercise. right cardiac mechanics during semiupright bicycle exercise tests under hypoxic conditions (i.e., 50 watts under 12% fio2 for 3 min) were measured using two-dimensional speckle-tracking echocardiography. the primary outcome was the change in right cardiac mechanics during semiupright bicycle exercise under hypoxic conditions (i.e., 50 watts under 12% fio2 for 3 min) as measured by two-dimensional speckle tracking echocardiography.

Eligibility criteria:
inclusion criteria: * having a sedentary lifestyle (without regular exercise, exercise frequency ≤ once weekly, duration \< 20 min). exclusion criteria: * exposed to high altitudes (\> 3000 m) for at least 1 year. * smoker * taking medications or vitamins * having any cardiopulmonary/hematological risk.

Keywords: stress echocardiography hypoxia test speckle-tracking echocardiography high intensity interval training
clinical trial to assess rate of onset of bronchodilator action in severe stable chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe copd after a single dose treatment.

this is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.

Eligibility criteria:
inclusion criteria: * males and females aged ≥ 40 years * current or ex-smokers of ≥ 10 pack-year * clinical diagnosis of severe stable copd exclusion criteria: * history or current diagnosis of asthma, allergic rhinitis, or atopy * respiratory tract infection or acute copd exacerbation in the last 6 weeks * hospitalised for an acute copd exacerbation in the last 3 months * evidence of contraindicated use of anticholinergic drugs

Keywords: copd
response rate to ceftriaxone 1g im in gonorrhoea : a french retrospective monocentric study

Conditions: Gonorrhea

Summary: sexual health centers (cegidd, in france) manage the majority of sti in france, especially gonorrhea. patients wanting sti screening can consult either they are symptomatic or not. if they are symptomatic, they can be treated immediately. if they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary. before any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform amr surveillance. after every treatment for gonorrhea, subjects should realized a test of cure (toc) according to current recommandation. response rate to ceftriaxone 1g im for treating gonorrhea has never been evaluated in france while being used widely over the past months. compliance to current recommandation at cegidd montpellier has never been evaluated. this study will assess the response rate to ceftriaxone 1g im as gonorrhea treatment by realizing a test of cure 14 days after each treatment.


Eligibility criteria:
inclusion criteria: * aged more than 18 years old * non-opposition form given to the subject * having at least one exam positive for gonorrhoea (pcr or culture), realised in cegidd de montpellier exclusion criteria: - patient's refusal to participate

Keywords: neisseria gonorrhoea ceftriaxone treatment
nifedipine (adalat cr, bay a1040) high dose pk/pd study

Conditions: Hypertension

Summary: this is a multi-center, randomized, double-blind, 6 x 3 cross-over study. all patients who meet the entry criteria will be required to stop taking any other anti-hypertensive agents than adalat cr (controlled release), if taken, before starting 4 weeks (±7days) open-label adalat cr 40 mg once daily (od) treatment phase (baseline treatment period). of them, those who are confirmed with their eligibility as subjects for the present study at the end of the baseline treatment period will be randomly allocated to one of the 6 treatment sequences on the basis of a computer-generated randomization list. subsequently, bay a1040 cr tablet 40 mg od, 40 mg twice daily (bid) or 80 mg od will be administered to a total of 6 weeks, 2 weeks per each treatment period (period 1-3) under double-blind conditions using bay a1040 cr tablet 40 mg and its placebo as follows (double-blind treatment period).

issues on safety are addressed in the adverse event section.

Eligibility criteria:
inclusion criteria: * male and female * 20 years or older and less than 75 years * outpatient * untreated or treated patients with antihypertensive agents whose blood pressure (bp) in sitting position at entry (visit 1) is as follows. * untreated patients: systolic blood pressure (sbp) \>= 160mmhg or diastolic blood pressure (dbp) \>= 100mmhg * treated patients: sbp \>= 140mmhg or dbp \>= 90mmhg (at trough) exclusion criteria: * patients whose bp during baseline treatment period is: sbp\>=200mmhg or dbp\>=120mmhg. * patients with secondary hypertension or hypertensive emergency. * patients with cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack (tia), myocardial infarction or unstable angina), or with history of these within 6 months prior to the study. * patients with intracranial or subarachnoid hemorrhage, or with history of these within 6 months prior to the study. * patients with server hematopoietic dysfunction (acute/chronic leukemia, myeloma, malignant lymphoma, myelodysplastic syndrome, aplastic anemia), or with history of these.
efficacy and safety of cd5024 1% in acne vulgaris

Conditions: Acne

Summary: exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of cd5024 1% cream over a 6-week treatment period compared to its vehicle.

study drugs application will be performed once daily, 5 days a week during 6 weeks

Eligibility criteria:
inclusion criteria: 1. the subject is a male or a female aged from 18 to 35 years old at screening visit. 2. the subject has a medical diagnosis of acne vulgaris : 2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) at baseline 2.2 symmetry of the lesions: no more than twice as many acne lesions on one side as compared to the other side at baseline 3. if the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study exclusion criteria: 1. the subject has an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (screening). 2. the subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment. 3. the subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see investigator's brochure/product label). 4. the subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (screening and baseline).
dermatological evaluation of topic compatibility-dermacyd delicata pocket br

Conditions: Healthy

Summary: the purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product dermacyd pocket br.


Eligibility criteria:
inclusion criteria: * phototype skin i,ii, iii e iv * integral skin test in the region exclusion criteria: * lactation or gestation * use of antiinflammatory and/or immunosuppression drugs * personnel history of atopy * history of sensitivity or irritation for topic products * active cutaneous disease * use of new drugs or cosmetics during the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: hygiene
attitudes towards back and back pain in german-speaking switzerland

Conditions: Low Back Pain

Summary: this research aims to assess the cross-cultural validity and reliability of the german version of the back-paq (back-paq_g) within the german-speaking swiss population. the target population for this study includes individuals with and without back pain and primary care healthcare professionals. this includes physicians, physiotherapists, and nurses. the participants will be asked to fill out the back-paq_g and similiar questionnaires online.


Eligibility criteria:
inclusion criteria: * living within the german-speaking part of switzerland exclusion criteria: * insufficient german language skills
a safety and efficacy study for epoetin alfa in pre-dialysis subjects.

Conditions: Anemia; Kidney Failure; Left Ventricular Hypertrophy

Summary: the purpose of this study is to determine if using eprex, to maintain hemoglobin within the normal range, will prevent or delay the progression of left ventricular mass growth.

cardiovascular disease continues to be the major cause of morbidity and mortality in subjects with renal (kidney) disease. left ventricular hypertrophy (lvh) has been correlated with a high risk of cardiac and all cause mortality. in the renal population , many factors have been shown to be important in the development of lvh, including anemia. this is a multicentre, open, controlled, randomized trial to determine if maintaining hemoglobin within the normal range delays the progress of left ventricular mass growth. additionally, this study will evaluated the safety of maintaining hemoglobin within the normal range in pre-dialysis subjects. the trial duration is 24 months. subjects randomized to the treatment arm will receive eprex therapy to maintain hemoglobin between 120-140 g/l. subjects randomized to the control arm will not receive any treatment unless their hemoglobin falls to less than or equal to 90 g/l. those subjects will then be treated to maintain their hemoglobin between 90-105 g/l. the subjects were to receive injections of eprex once weekly to maintain hemoglobin levels within the target range for the arm to which they were randomized. the subjects were to receive treatment for up to 24 months.

Eligibility criteria:
inclusion criteria: * patients have had a decrease in hemoglobin \>= 10 g/l within the past 12 months and a current hemoglobin level between 110-135 g/l (men) and 100-135 g/l (women) or a hemoglobin level between 115-125 g/l (men) and 110-120 g/l (women) * have a calculated creatinine clearance \ 15 ml/min exclusion criteria: * no uncontrolled hypertension (diastolic blood pressure\>= 105 mm hg on average for the previous month) no unstable angina or cardiac procedure within the past 12 months or a planned procedure * no myocardial infarction with the past 12 months

Keywords: anemia epoetin alfa
chemotherapy combined with radiotherapy vs chemotherapy alone for distant metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: this is a randomized parallel control trial to evaluate whether radical loco-regional radiotherapy can prolong survival time of initial untreated metastatic nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * the patients with initial untreated metastatic nasopharyngeal carcinoma * histologic diagnosis of nasopharyngeal carcinoma * t1-4n0-3m1,ivc(according to the 7th ajcc edition) * aged between 18 and 65 years * kps≥70 * the therapeutic effect evaluation is cr or pr accomplished three course of cisplatin and 5-fu * voluntary to participate and sign informed consent document exclusion criteria: * the patients suffered from serious neurologic disease * clinically significant cardiac, heart function less than or equal to 3 level * clinically significant respiratory disease,lung function less than or equal to 3 level * blood routine examination: wbc\<3×109/l, hemoglobin\<90g/l, platelet count\<75×109/l * abnormal liver function: total bilirubin or alt or ast\>2×uln * abnormal renal function:serum creatinine\>1.5×uln * pregnant or lactating women * the therapeutic effect evaluation is sd or pd accomplished three course of cisplatin and 5-fu

Keywords: initially untreated distant metastatic