Kornimate/medical-research-clean huggingface dataset:
a pharmacokinetic study of dapivirine vaginal rings in belgium

Conditions: HIV Infections

Summary: ipm 018 is a double-blind, randomized, placebo-controlled study conducted at one site in belgium among 24 healthy, hiv-negative women to evaluate dapivirine release for 28 days from matrix and reservoir intravaginal rings, each containing 25 mg of dapivirine, and to assess safety and tolerability compared to placebo


Eligibility criteria:
inclusion criteria: * women between 18 and 35 years of age * willing and able to give written informed consent * available for all visits and consent to follow all procedures scheduled for the study * healthy and hiv-negative as determined by a hiv-1 elisa test at time of enrollment; * willing to abstain from sexual activity for the duration of the study * willing to use oral contraceptives to avoid menstruation while taking part in this study or on long-acting progestins for 6 months prior to enrollment * upon pelvic / speculum examination at enrollment, the cervix and vagina appear normal * willing to refrain from use of vaginal products or objects for the duration of the study. exclusion criteria: * history of alcoholism, drug abuse, psychosis, antagonistic personality, poor motivation, or other emotional or intellectual problems that are likely to invalidate the informed consent process or adversely impact compliance with protocol requirements; * history of sensitivity / allergy to latex, dapivirine or to the constituents of the vaginal ring (i.e. silicone elastomer) * currently pregnant or breast-feeding, or within three months of last pregnancy outcome * currently or within one month of participating in any other clinical research study * history or diagnosis of and / or treatment for a sexually transmitted disease within the last three months * history of genital tract surgery within the last month * current diagnosis of sexually transmitted infections (gonorrhea, chlamydia and trichomonas) * current vulvar or vaginal symptoms / abnormalities that could influence the study results * history of significant urogenital or uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last three months; * smoking more than 10 cigarettes per day

Keywords: hiv-1 infection hiv seronegativity
bisphosphonates and impaction grafting in hip revision

Conditions: Aseptic Loosening of the Hip Prosthesis

Summary: the primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur.

morsellized compacted bone allograft can be used for revision arthroplasty of the hip. treating the graft locally with an antiresorptive substance such as a bisphosphonate has decreased the graft resorption in animal studies and led to a remained bone density in a human series of 16 patients. in the present study we investigate if this increased bone density of the graft also causes a decreased micromotion of the implant relative the femur. 36 patients are planned to participate in a 1:1 randomized and prospective study comparing the bisphosphonate clodronate to saline. primary outcome will be micromotion over the first year but also secondary parameters such as late micromotion (between 12 and 24 months), re-loosening subjective outcome and safety. we hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption and therefore may reduce the risk of mechanical failure. patients are followed with radiograms, rsa (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and subjective months and subjective parameters including womac and sf 12. the treatment is simple, cheap and appears virtually risk-free.

Eligibility criteria:
inclusion criteria: * patients with aseptic loosening and osteolysis scheduled for hip revision using allograft and impaction technique * obtained informed consent * pregnancy excluded in women of childbearing age exclusion criteria: * patients with known renal disease or s-creatinine \>175 mcmol/l * patients with s-calcium 2.75 mmol/l * patients with diagnosed rheumatoid arthritis * patients with active primary hyperparathyroidism

Keywords: surgical procedures operative prosthesis implantation arthroplasty replacement
combination of clopidogrel and aspirin for prevention of early recurrence in acute atherothrombotic stroke

Conditions: Stroke

Summary: primary objective: * comparison of efficacy of the combination therapy (clopidogrel plus aspirin) and the aspirin alone (main comparison) to prevent any recurrent ischemic lesion . secondary objectives: * comparison of modified rankin scale (mrs) scores; * comparison of the incidence of all kinds of stroke and vascular death; * comparison of the incidence of bleeding episodes (major and minor) and symptomatic intracerebral hemorrhages during the follow-up period.


Eligibility criteria:
inclusion criteria: * ischemic stroke diagnosed within 48 hours from symptom onset; * cerebral ischemic lesion observed on diffusion-weighted magnetic resonance imaging (dwi mri); * relevant atherothrombotic lesions on magnetic resonance angiography (mra) or computed tomography angiography (cta); * study drug administration within 48 hours from symptom onset; * mrs score is 0-2 before the stroke. exclusion criteria: * evidences of other relevant brain lesions such as intracerebral hemorrhage (ich) or brain tumor; * suspicious of stroke due to small-vessel occlusion; * stroke due to cardioembolism; * clinical necessity of conventional angiography or intervention before the end of study; * past history of ich; * bleeding diathesis or coagulopathy; * chronic anemia (hb\<8.0) or thrombocytopenia (plt\<100k); * chronic liver disease (ast\> 100 or alt\>100); * any other clinically relevant serious disease, including renal failure ( creatinine clearance\<30ml/min); * allergy to aspirin or clopidogrel; * subjected to intervention or surgical treatments within 3 months; * thrombolysis performed with rt-pa or uk after the stroke; * participation in another clinical study within the previous 30 days; * suspicious of poor drug compliance and requirements of the protocol; * females who are pregnant, breast-feeding, or childbearing potential and not using medically acceptable and effective contraception. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
evaluating optimal timing of endocrine therapy and radiation therapy in early-stage breast cancer (react-rett)

Conditions: Early-stage Breast Cancer

Summary: react-rett will demonstrate the non-inferiority of concurrent compared to sequential endocrine therapy in patients receiving post-operative radiotherapy for early stage breast cancer.

clinical equipoise exists around the optimal time to start adjuvant endocrine therapy in patients who will receive post-operative radiotherapy for breast cancer. patients receive either concurrent or sequential endocrine and radiation therapy, where concurrent therapy consists of endocrine therapy started before, with or during radiotherapy, while sequential treatment is defined as endocrine therapy starting after the completion of radiotherapy. a recent survey of canadian oncologists showed that the main reason for prescribing sequential endocrine therapy was a concern that concurrent endocrine therapy and radiotherapy would worsen the toxicity of endocrine treatment. this is despite the absence of any clinical trial evidence to support this. indeed, a recent systematic review by our group was unable to confirm or refute whether increased toxicities, related to the timing of endocrine therapy and radiotherapy actually exist in clinical practice. the investigators are therefore proposing a pragmatic randomised trial to assess whether or not concurrent endocrine therapy and radiotherapy worsens endocrine treatment-related symptoms in an era of modern endocrine and radiation therapy.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed early stage, hormone receptor positive breast cancer * planned to receive both endocrine therapy and post-operative radiotherapy * able to provide verbal consent exclusion criteria: * previous endocrine therapy for invasive breast cancer * previous radiotherapy for breast cancer in the same breast

Keywords: radiation therapy endocrine therapy
efficacy of a eugenol-based product to improve the quality of toothbrushing and relieving gum discomfort areas

Conditions: Plaque, Dental

Summary: the objective of this study is to evaluate the efficacy of a eugenol-based product in improving the quality of toothbrushing and relieving areas of gingival discomfort. this is a randomized, controlled, parallel, examiner-blind clinical trial.


Eligibility criteria:
inclusion criteria: * you must provide consent to participate by signing this informed consent form. * available for the two(2) week study duration. * you must be at least eighteen(18) years old and not older than seventy(70) years of age. * you must not smoke. * you must be in good general health for participation in the study, based on the opinion of the study investigator. * you must have at least 20 natural permanent teeth. * your teeth must meet the scoring entry criteria for dental plaque and gingivitis(gum inflammation) at the discretion of the study examiner. * you must meet the scoring criteria for gum discomfort, determined using your responses to the survey questionnaire. * you must have no known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner. exclusion criteria: * medical condition which requires premedication prior to dental visits/procedures. * presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations. * advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months. * five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care. abnormalities/diseases of the soft or hard oral tissues. * orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring) * current smokers and/or tobacco users and/or a history of alcohol or drug abuse. * use of drugs that can affect salivary flow. * use of antibiotics one (1) month prior to study entry and/or during participation in this study. * use of any over the counter medications other than analgesics that could interfere with the study at pi discretion. * self-reported pregnancy and/or breastfeeding. * current participation in another clinical study or during the month prior to this clinical study entry. * known allergies and/or reactions to common dentifrice ingredients. * medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits. * immunocompromised conditions (aids, immunosuppressive drug therapy). * infectious disease and/or other blood borne diseases (hepatitis series, hiv, tuberculosis).

Keywords: plaque gingivitis
bausch health thermage fxl for use on lower face and submentum area

Conditions: Skin Wrinkling

Summary: this study is designed to evaluate the safety and efficacy of sequential use of monopolar radiofrequency on lower face and submental area, followed by cryolipolysis on the submentum and submandibular area for fat reduction and improvement of skin laxity.

this research study will study subjects who have mild to moderate skin laxity on lower jaw and submentum areas. this will be measured by conducting a treatment using the thermage flx system on the lower face and submentum area of the participants. biopsies will be done on several locations throughout the 12 week trial to assess skin laxity through laboratory measures. finally, the subject will be asked to complete questionnaires to provide satisfaction and tolerability feedback.

Eligibility criteria:
inclusion criteria: * female subjects \> 40 years of age and \< 80 years of age. * presence of mild to moderate skin laxity on lower face and submentum area, which in the investigator's opinion may benefit from monopolar radiofrequency to improve the skin laxity for a youthful, rejuvenated appearance. * bmi under 35. * agreement to maintain their weight within 5 lb of the baseline. * subject has read and signed a written informed consent form. exclusion criteria: * subject has severe skin laxity in the area of intended treatment which in the opinion of the investigator, may result in an unacceptable aesthetic result. * subject has had a surgical procedure(s) in the area of intended treatment. * history of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), in or around the area of intended treatment. * subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. * currently taking or has taken diet pills or weight control supplements within the past month. * any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation. * active implanted device such as a pacemaker, defibrillator, or drug delivery system. * pregnant or intending to become pregnant in the next 6 months. * lactating or has been lactating in the past 6 months. * bmi ≥ 35. * unable or unwilling to comply with the study requirements. * currently enrolled in a clinical study of any other unapproved investigational drug or device. * any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
the safety and effectiveness of tocilizumab in rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the aim of this study is to investigate the safety and effectiveness of tocilizumab (actemra®) using chinese rheumatology information platform (crip) on chinese rheumatology data centre (crdc, http://www.crdc.org.cn/) in chinese ra patients.

tocilizumab (actemra®) is a humanized monoclonal antibody targeting the human il-6 receptor, which inhibits the binding of this cytokine to its receptor. it is the first monoclonal antibody developed for ra treatment with this mechanism of action and has been approved by regulatory authorities in china since 2013. data from five phase iii studies with over 4000 recruited patients have shown that tocilizumab at a dose of 8 mg/kg, in combination with methotrexate/dmards or as monotherapy, can produce a quick and clinically relevant improvement in ra signs and symptoms, health status, and prevent joint damage, for both patients who have not been previously treated with and refractory to methotrexate, other dmards or anti-tnf agents. however, in real-world clinical setting, the safety profile and treatment pattern with regard to the persistence on tocilizumab and the efficacy are not clear in china. the aim of this study is to investigate the safety and effectiveness of tocilizumab using chinese rheumatology information platform (crip) on chinese rheumatology data centre (crdc, http://www.crdc.org.cn/) in chinese ra patients.

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age. * patients with a diagnosis of ra according to the revised (2010) acr criteria. * patients per treating physician's judgment to treat with tocilizumab. * signed written informed consent exclusion criteria: * patients are receiving or have received any investigational agent 4 weeks (or 5 half-lives of investigational agent, whichever is longer) prior to enrollment of this study. * subjects with contra-indications to tocilizumab therapy as detailed in the label (with known hypersensitivity to tocilizumab or accessories; or with active infections.).

Keywords: rheumatoid arthritis tocilizumab safety
strong for surgery & strong for life - against all odds: intensive prehabilitation for risk reduction in cancer surgery

Conditions: Risk Reduction; Urological Cancer; Surgery; Life Style

Summary: despite knowledge about the effect of preventive measures in lifestyle, smoking,nutrition, alcohol and physical activity (snap), there is a lack of systematic assessment of the overall lifestyle of the patient before surgery and knowledge about how lifestyle interventions can be organized in connection with cancer surgery. the intention with prehabilitation is to optimize the individual's risk factors and personal burdens that can affect the clinical and patient reported outcomes after surgery. the aim of this study is to evaluate the efficacy of intensive snap interventions compared to treatment as usual (tau) in ptt undergoing urological cancer surgery on surgical risk reduction.

the project contains three clinical intervention studies, in total including 100 urological cancer patients screened positive for at least 1 snap factor: i. efficacy and preferences of intensive snap-interventions among patients with at least one snap factor and undertaking neo-adjuvant chemotherapy before radical cystectomy. a randomised controlled trial with nested interviews (42 patients). ii. implementation and preferences of intensive snap-interventions among patients with kidney cancer undergoing nephrectomy/partial nephrectomy. an implementation feasibility study including interviews (20 patients). iii. reach out and effect as well as preferences of perioperative intensive smoking cessation intervention via the municipality clinic compared to the surgical department among smokers with non-invasive bladder cancer treated with trans-urethral resection of the bladder (tur-b). a randomised controlled trial with nested interviews (38 patients). the intervention groups receive minimum five educational sessions tailored to individual needs over six weeks perioperatively. the control groups receive standard care.

Eligibility criteria:
inclusion criteria: * patients \> 18 years scheduled for cystectomy due to bladder cancer * referral to neoadjuvant chemotherapy * screened positive for minimum 1 snap factor * signed informed consent exclusion criteria: * pregnancy and breastfeeding * allergy to pharmaceutical support (nicotine replacement therapy, disulfiram) * contraindications to exercise.

Keywords: postoperative complications prehabilitation surgical risk reduction smoking alcohol drinking physical activity malnutrition obesity patient preferences randomised controlled trial
analysis of immune response in bacterial infection of obese subject

Conditions: Obesity

Summary: improve knowledge of the immune response to sepsis in obese patients. define immunological and genetic prognostic factors of severe infections which can motivate a change in the therapeutic attitude


Eligibility criteria:
inclusion criteria: * between18 and 80 years * obesity: bmi \> 30 * presumed bacterial infection: * pneumonitis (documented or probably) * pyelonephritis / acute prostatitis * soft tissue / skin infection (except for bedsore) * cholecystitis / angiocholitis * meningitis * clostridium colitis * surgical site infection * signed consent exclusion criteria: * patients with viral, parasitic or mycotic documented infection * patients with bacterial infection with treatment\> 4 weeks (ex. endocarditis; osteo- articular infections) * patients with prior antibiotic treatment (\< 14 days) * intensive care unit patients * patients with a history of cancer or malignant hematological disease within the 5 previous years that is currently clinically significant (non metastatic prostatic and basocellular malignancy are excluded) * patients with systemic disease * known diagnosis of human immunodeficiency infection (dicv, hiv...) * immunosuppression treatment during last month including corticotherapy * pregnancy * 3 months follow up not possible * non signed consent
a study to evaluate the combination of pegylated interferon alfa plus valopicitabine in patients with hepatitis c

Conditions: Chronic Hepatitis C

Summary: this phase ii study is being conducted in treatment-naive patients (no previous antiviral therapy for hepatitis c infection) with genotype-1 chronic hepatitis c to evaluate the safety and effectiveness of valopicitabine alone and together with pegylated interferon (a drug approved by the food and drug administration for the treatment of hepatitis c infection).


Eligibility criteria:
inclusion criteria: * documented clinical history of genotype-1 chronic hepatitis c and compensated liver disease * treatment naive (patient has received no previous treatment for chronic hepatitis c infection) * other protocol-defined inclusion criteria may apply. exclusion criteria: * patient is pregnant or breastfeeding * patient is co-infected with hiv or hepatitis b * other protocol-defined exclusion criteria may apply.

Keywords: genotype-1, chronic hepatitis c
the cusa clarity soft tissue removal study

Conditions: Benign, Malignant Tumors or Other Soft Tissue Removal; Nephrectomy or Partial Nephrectomy With Parenchyma Removal

Summary: to investigate the clinical performance and surgeon preferences of the cusa® clarity ultrasonic surgical aspirator system for soft tissue removal during surgical procedures. this will be evaluated through the effectiveness of soft tissue removal per surgeon assessment and incidence of adverse device effects.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age * subject requires removal of soft tissue with an ultrasonic aspirator during urological or general surgery * subject is an appropriate candidate to receive use of the cusa® clarity ultrasonic surgical aspirator system product for soft tissue removal during surgery, per the study surgeon * subject signed the irb/ec-approved informed consent form demonstrating that the subject is willing and able to participate in this clinical study and to comply with all study procedures, if applicable. exclusion criteria: * subject is currently pregnant or plans to become pregnant prior to the study index surgery * subject has any significant medical condition that in the opinion of the investigator will interfere with protocol evaluation and participation * subject's surgical plan includes utilizing cusa® clarity ultrasonic surgical aspirator system for the removal of uterine fibroids * subject is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or ethics committee. * intra-operative exclusion criteria : surgeon does not utilize the cusa® clarity ultrasonic surgical aspirator system for soft tissue removal during surgery.
comparison of the results of treatment by gamma nail versus dynamic hip screw for unstable intertrochanteric hip fractures

Conditions: Intertrochanteric Fractures of the Hip

Summary: the study hypothesis is the the results of the use of gamma nail will be superior to the use of dynamic hip screw for unstable intertrochantric hip fracture.


Eligibility criteria:
inclusion criteria: * patients diagozied with acute intertrochantric unstable fracture * a minimum minimental score of 6 * ability to walk 500 meters indepedently exclusion criteria: * pathological fracture * multiple fractures * neurological conditions
static stretching on postural sway and plantar pressures

Conditions: Muscle Stretching Exercise; Postural Balance; Stabilometry; Platform

Summary: risk for falls has been associated with falls efficacy and postural balance. the objective was to compare the effects on the footprint and the stabilometry of the continuous stretch and the intermittent. subjects were randomly assigned to an intermittent stretching protocol group or continuous stretch group both of them loading passive plantar flexor stretching. static footprint and stabilometry were measured before and after both protocols.


Eligibility criteria:
inclusion criteria: * non-trained individuals * healthy subjects exclusion criteria: * previous surgery on the lower extremities * injuries * musculoskeletal conditions