Kornimate/medical-research-clean huggingface dataset:
a randomized controlled trial of a bone density decision aide

Conditions: Osteoporosis

Summary: this research study is being conducted to determine if a modified bone mineral density (bmd) test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy. it is hypothesized that this supplementary information, provided in addition to the conventional bmd report, will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis.

this observational research study is being conducted to determine if a modified bone mineral density (bmd) test report that contains additional fracture risk information will be a useful physician decision aide in selecting patients for pharmacological osteoporosis therapy. it is hypothesized that this supplementary information, provided in addition to the conventional bmd report, will increase the likelihood that patients at high risk for an osteoporotic fracture will receive prescribed therapy for osteoporosis. physicians who only receive the conventional bmd reports without the supplemental information will be the control group. to compare the rates of pharmacological interventions for osteoporosis in post-menopausal women, family / primary care physicians are randomized to receive either:(i) a conventional bmd report (absolute bone density, t-score result, z-score result, qualitative statement indicating the bmd results classification of risk for fracture from osteoporosis according to the world health organization (who) criteria) versus (ii) a conventional bmd report plus a supplemental information sheet (all the information contained in the conventional bmd report plus five-year estimated risks for future fractures calculated from the physician-supplied clinical risk factors and - for those who have osteoporosis according to the who criteria - the number needed to treat (in person years) to prevent one fracture.

Eligibility criteria:
inclusion criteria: * physicians involved in referring patients for dxa bone density testing exclusion criteria: * none

Keywords: osteoporosis fractures, bone bone mineral density
epidemiology of papillomavirus infection (hpv) on infected women by human immunodeficience virus (hiv) in west indies and french guiana.

Conditions: 1- Women; 2- HIV Infection; 3- Followed in West Indies and French Guiana for His Infection; 4- Acceptance of the Use of Nadis® Medical Files

Summary: cervical cancer is a public health problem. in term of frequency and mortality, it represents in martinique the third localization the most frequently diagnosed and the fifth cause of death by cancer. cervical cancer is recognized as viro-inducted. human papillomavirus (hpv) is the etiologic agent, as a necessary but not sufficient cause, in the cancer genesis. it is estimated than about 70 to 80% of women have been or will be infected with an hpv in their genital life, the risks factors being those of the others sexually transmitted diseases (std). most of hpv infection are transient, by spontaneous clearance in a few months of the virus under episomal form. carcinogen risk is related to viral persistency which inducts the condition of cellular transformation. infection persistency and subsequent carcinogen risk depend of the genotype concerned and of the host immunitary response. hiv infection is known to be associated with an higher prevalency of one or several infection with hpv-hr. however, no data about hiv/hpv coinfection prevalency are available nowadays in french overseas department of south america whereas they are the most affected by hiv.


Eligibility criteria:
inclusion criteria: * women aged 18 years old or beyond * infected with hiv1 or hiv2 * follow up for hiv infection in one of the center participating in the study and acceptance of the use of nadis® medical files * in one of the center participating in the study and acceptance of the use of nadis® medical files within the context of follow up that should be realized according to the recommandation of undertaking: systematic pap smear for asymptomatic patient s (expert's report, pr.p.yéni) or pap smear for classical searching of any pathology of the uterine-cervix. * acceptance of involvement into the study and collection of non opposition to the realization of hpv search from the sample realized for the pap smear. exclusion criteria: * women under age * history of total hysterectomy * patient not followed for hiv infection in one of the center involved in the study * patient that did not accept the use of nadis® medical files * impossibility to realize a pap smear * refusal of study's participation

Keywords: hiv, hpv, cervical-vaginal smear
prevention of gastric ulcer bleeding by using "computer-alert" in general practice

Conditions: Bleeding Peptic Ulcer

Summary: the purpose of this study is to investigate if a computerised decision-support tool used in general practice, can reduce the frequency of peptic ulcer bleeding related to the use of nsaids (non-steroidal-antiinflammatory-drug) and asa( acetylsalicylic acid) . on the basis of "the danish general medical database" it is possible to develope a computerised decision-support tool, which enables the general practitioner (gp) in a "pop-up" window to get information on each patients risk-factors, when prescribing nsaid and aspirin to a patient at risk. this will give the general practitioner the oppurtunity to choose a different type of preparation or prescribe ulcer-preventive medicine at the same time. the decision-support tool will be tested in a randomized trial among general practitioners. the aim is to reduce the occurence of peptic ulcer bleeding. the expected outcome is a reduction in half of the total numbers of peptic ulcers.

the background of the study is that nsaids and aspirins increase the risk of peptic ulcer bleeding. on average 1-2% of patients using nsaid and aspirin will develope gastric ulcer bleeding. but for patients with one or more risk-factors, the risk increases to 9% per 6 months. the mortality in this case is 10-15%. approximately 3200 patients are admitted to the hospital with bleeding ulcer annually in denmark. danish investigations have shown that 80% of all peptic ulcer bleedings admitted to hospital are related to the use of nsaid or aspirin. the consumption of nsaid and aspirin is large. a third of people over 60 are treated within a year with these preparations. the risk of developing gastric ulcer related to nsaid and aspirin can be reduced by concomitant therapy with antacids. several studies have shown that only 20-30% of patients with risk-factors receive ulcer preventive medicine.

Eligibility criteria:
inclusion criteria: * general practitioners in the region of southern denmark which are linked to danish general medical database for minimum 6 months exclusion criteria: -

Keywords: bleeding peptic ulcer nsaid and aspirin computer-alert general practitioner
pedometer and exercise study in prostate cancer patients with hormonal therapy

Conditions: Prostate Cancer

Summary: a randomized clinical trial evaluating the use of a pedometer and brief exercise coaching in prostate cancer patients treated with androgen deprivation therapy. the investigators want to demonstrate if there are less side effects of hormonal therapy and better quality of life in patients who made regular exercise.

to evaluate effectiveness of regular exercise and well-being all patients will complete questionnaires about sexual function (iief-15) and quality of life. we will also perform at each visits anthropometrics measurement of waist, leg and arm, weight and vital signs. biochemical analysis and prostatic specific antigen will be done periodically.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * histologically proven prostate cancer * treatment plan is to administer long term adt (androgen deprivation therapy). * patient must currently be treated with adt for at least 2 weeks before enrollment in trial, and for no more than 6 months. patient treated with a maximum androgen blockade strategy, combining an anti-androgen agent with a lhrh analog agent are admissible to this protocol, but not patients treated only with an anti-androgen agent alone. * written informed consent to participate in the trial. exclusion criteria: * known hypersensitivity to zoladex, casodex (if applicable), or any component of these product, or to other similar agents * severe cardiac disease (new york heart association class iii or greater) * severe lung disease * uncontrollable pain * unstable bone lesion * any co-morbidity restraining the patient's ability to walk alone or to modify his walking habits (eg parkinson's disease, advanced multiple sclerosis, leg amputation, ...) * any concomitant condition that would make it undesirable, in the physician's opinion, for the subject to participate in the trial or would jeopardize compliance with the protocol. * any contraindication to undertake the 6-minutes walk test (unstable angina or myocardial infarction during the previous month, a resting heart rate of more than 180, systolic blood pressure of more than 180, and a diastolic pressure of more than 100). the patient must have his cardiovascular conditions stabilized and controlled before enrollment in the trial. * unwillingness or incapacity to consent to trial participation.

Keywords: pedometer prostate cancer hormonotherapy exercise
race 2: a long term follow-up of patients participating in the race trial

Conditions: Severe Aplastic Anemia

Summary: after exiting the race trial (nct02099747) patients will be invited to participate in this long term follow-up study

patients will be followed up annually, according to standard of care. all diagnostic and therapeutic intervention will be performed according to standard of care, at discretion of the treating physician. in particular, during the study no extra peripheral blood or bone marrow sampling will be performed, in addition to routine sampling for morphology and karyotype surveillance. molecular analysis by next generation sequencing (ngs) will also be collected if the centre is doing this on a routine basis. no investigational medicinal product (imp) or non-investigational medicinal product (nimp) will be given to the patients.

Eligibility criteria:
inclusion criteria: 1. subject participated in the race trial (nct02099747, eudract number: 2014-000363-40) during which patient received atgam, cyclosporine a with or without eltrombopag. 2. subject has provided informed consent to participate in long-term data collection exclusion criteria: none
study of urg101 in painful bladder syndrome and interstitial cystitis

Conditions: Painful Bladder Syndrome; Interstitial Cystitis; Bladder Pain Syndrome

Summary: a double-blind, placebo-controlled study to evaluate changes in pain, urgency and urinary frequency following administration of urg101 compared to placebo.


Eligibility criteria:
inclusion criteria: * male and female subjects \>= 18 years of age * moderate to severe symptoms of pbs/ic * minimum pain/urgency/frequency scores * female subjects on hormone therapy must be on stable dose for \>= 3 months exclusion criteria: * positive pregnancy test or pregnant or lactating * narcotics or medical marijuana within 3 months * use of any investigational drug or device within 30 days * bacterial cystitis within 30 days

Keywords: bladder pain urgency frequency
xtx202 in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: a first-in-human, multicenter, phase 1/2, open-label study of xtx202 in patients with advanced solid tumors

this is a first-in-human, phase 1/2, multicenter, open-label study designed to evaluate the safety, tolerability, and efficacy of xtx202, an engineered il-2 prodrug with its activity masked, as monotherapy in patients with advanced solid tumors. phase 1 part 1a will examine xtx202 monotherapy in an accelerated and standard 3+3 dose-escalation design. based on the results of part 1a, part 1b will be initiated to further examine xtx202 in patients with select advanced solid tumors and to further characterize xtx202. based on results of phase 1 patients with select advanced solid tumors will be enrolled in phase 2.

Eligibility criteria:
inclusion criteria: 1. disease criteria * phase 1, part 1a: any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or standard therapy is not curative or available * phase 1, part 1b: histologically or cytologically confirmed solid tumor malignancy with one of the following tumor histologies: rcc of clear cell histology only, melanoma, squamous cell skin carcinoma, ovarian cancer, non-small cell lung cancer. those patients who previously received immunotherapy must have derived benefit from this treatment. additionally, patients with any of the above histologies in an advanced setting who plan to undergo debulking surgery or oligometastasectomy may be eligible to receive 2 cycles of xtx202 treatment in a "window of opportunity" subcohort". * phase 2, part 2a: patients with metastatic rcc who have previously been treated with an anti-pd-1 and a tki, per local and institutional soc. patients must have progressed on treatment with an anti-pd-1 mab administered either as monotherapy or in combination with other therapies * phase 2, part 2b: patients with unresectable or metastatic melanoma who have previously been treated with at least 1 prior line of therapy in the recurrent or metastatic setting. prior therapy must have included an anti-pd-1 alone or in combination per local and institutional standard of care, and patient must have progressed on checkpoint inhibitor therapy. patients with braf v600-activating mutation must have previously received targeted therapy per local and institutional standard of care. 2. ecog performance status of 0 or 1 3. adequate organ function 4. part 1b only patients must be willing to provide fresh tumor biopsies before and after initiation of study treatment. exclusion criteria: 1. received prior treatment with il-2 therapy 2. history of clinically significant pulmonary disease 3. history of clinically significant cardiovascular disease 4. has a diagnosis of immunodeficiency 5. has an active autoimmune disease that has required systemic treatment in past 2 years, including the use of disease modifying agents, corticosteroids or immunosuppressive drugs 6. has an active infection requiring systemic therapy within 4 weeks prior to study treatment
prophylactic administration of vitamin c in wrist fractures

Conditions: RSD (Reflex Sympathetic Dystrophy); Algodystrophy; CRPS Type I

Summary: complex regional pain syndrome or posttraumatic dystrophy is a pain syndrome which develops after a trauma, surgery or for unknown reason. the incidence after wrist fractures varies in literature from 2 - 37%. the female sex is involved three times as much as the male sex. there is one study in literature which describes a prophylactic effect of vitamin c after wrist fractures. goal of this study is to search for a dose dependent effect of vitamin c and to replicate these earlier findings.

the trial was designed as a multicentre, randomized, controlled study. three hospitals in the netherlands participated in this study, using the same experimental design. adults (18 years or above) with a wrist fracture who were seen in the emergency department of each hospital were asked to participate in this study. patients were asked to start the trial medication on the day of the fracture. two capsules had to be taken once daily for 50 days. patients were allocated randomly to receive either placebo or a dosage of 200, 500 or 1500 mg of vitamin c daily. the endpoint of the study was defined as the presence of crps at any moment, in the period up to one year after the fracture. all participants and physicians were unaware of the treatment allocation. patients were seen after 1 week, 4 or 5 weeks (or when the cast was removed), 6 or 7 weeks, 12 weeks, and 26 weeks. after one year patients were interviewed by telephone or received an inquiry letter with a postage-paid envelope for their reply. the normal fracture treatment, either conservative or operative, was not compromised by the protocol, and if necessary patients were seen more often and/or at other times than planned. complex regional pain syndrome was diagnosed when four of the following five symptoms were present throughout an area larger than the wrist, including the area distal to the wrist (hand and fingers), and if they occurred or increased after activity: unexplained diffuse pain, which is not in normal relation to the fracture; difference in skin color relative to the other arm; diffuse edema; difference in skin temperature relative to the other arm; limited active range of motion, unrelated to the stage of fracture treatment. if crps was diagnosed, the end point of the study was reached and the protocol was terminated to enable treatment for crps.

Eligibility criteria:
inclusion criteria: * wrist fracture * adult (18 years and older) exclusion criteria: * no comprehension of the written information * not able to appear for follow-up (living abroad)

Keywords: reflex sympathetic dystrophy ascorbic acid primary prevention radius fractures
comparative analysis of outcome between extravesical and transvesical repair for vesico-vaginal fistula

Conditions: Vesico Vaginal Fistula

Summary: in patients with vesicovaginal fistula, transvesical and extravesical repair will be compared in terms of operative time, complications and recurrence rates.


Eligibility criteria:
inclusion criteria: * all patients with vesicovaginal fistula exclusion criteria: * uretrovaginal fistula
ofatumumab and bendamustine for previously treated chronic lymphocytic leukemia (cll)

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: the purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. all subjects enrolled on this study will receive both drugs by intravenous (iv) infusion.


Eligibility criteria:
inclusion criteria: * pathologically confirmed cll or sll requiring therapy * age 18 years of age or older * ecog performance status 0, 1, or 2 * normal organ and bone marrow function * resolution of toxic effects from prior therapies * ability to adhere to the study schedule and give written informed consent exclusion criteria: * any serious medical, psychiatric illness or laboratory abnormality * chemotherapy or radiotherapy within 4 weeks of entering the study * currently receiving other treatment for cll/sll or other malignancies * active other malignancies * history of allergic reactions to bendamustine or ofatumumab * ongoing corticosteroid use * pregnant or lactating * hiv positive * active hepatitis b * allogeneic transplant within 6 months of entering study or graft-versus-host disease.

Keywords: cll sll bendamustine ofatumumab
microbiome changes in severe burns

Conditions: Burns Greater Than 20% BSAB; Burns

Summary: the purpose of the study is characterizing changes in the microbiome of severely-injured adult patients as they progress through stages of injury, reconstruction, and recovery from burns.

there exists a vast collection of bacteria that live on, and within, each human body. all surfaces exposed to the external environment, such as the nares, mouth, airway, skin, and intestines, are colonized, and it is estimated that over 100 trillion microbes live within the gastrointestinal tract alone. the interactions between these colonizers and their host have been demonstrated to affect myriad aspects of human health from autism and inflammatory bowel disease to cancer therapy response. investigations into the role of the intestinal microbiome in sepsis have been ongoing for decades. data has shown that critically ill patients can not only experience increased intestinal permeability - a factor that allows for the translocation of bacteria and non-microbial tissue injurious factors into the, primarily lymphatic, circulation, but also a disruption of the symbiotic relationship to one of dysbiosis, resulting in what is known as a "pathobiome." that the microbiome is affected by thermal injury should be no surprise; burn injury has been shown to drive significant intestinal ischemia and inflammation with subsequently increased intestinal permeability. , burn-induced lung injury has been linked to these changes, and alterations in the microbiome between critically-burned patients (when compared with healthy controls) have been demonstrated, with resultant overgrowth of gram-negative anaerobes. thus, the microbiome has a clear role in affecting the clinical course of thermally-injured patients. this is a descriptive case series study examining microbiome changes in two adult patients admitted with severe burn injuries. this will be done by obtaining regular stool samples and analyzing the microbial content, as well as obtaining clinical data on patients including those factors likely to influence the microbial content.

Eligibility criteria:
inclusion criteria: * sustained greater than or equal to 20% body surface area of the body (bsab) exclusion criteria: * pre-existing clinical infections * historical evidence of gastrointestinal disease such as ulcerative colitis * crohn's disease * celiac disease * historical evidence of gastrointestinal clostridium difficile infection * no anti-biotic use for 3 months prior to admission * aids * immune suppressing medications or metastasized cancer * peritonitis * non english-speaking
data collection and analysis of patients who have had an electrophysiological procedure

Conditions: Heart Disease; Atrial Fibrillation

Summary: the purpose of the database is to complete outcomes research of electrophysiological procedures.

the purpose of the database is to complete outcomes research (risk factors, follow-up, procedural data) perhaps the most important research for any busy clinical laboratory is to appreciate the tendencies and trends that are occurring in their own laboratory setting. this will have a tremendous impact on educating the osu staff as well as perhaps other centers on best medical practices.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * have or had a procedure preformed in the electrophysiology laboratories at the ross heart hospital * ability to consent exclusion criteria: -

Keywords: electrophysiological heart disease cardiology atrial fibrillation risk factors follow-up outcomes