Kornimate/medical-research-clean huggingface dataset:
compliance with avonex® ps in patients with relapsing-remitting ms

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: a phase iv, observational, survey-based study to measure compliance with avonex® ps therapy in patients with relapsing-remitting multiple sclerosis, and to compare persistence on therapy 22 months after initial prescription of avonex® ps between patients enrolled in the current ms alliancetm program versus patients enrolled in this program prior to october 2007.

study design five hundred patients will be enrolled in the prospective portion of the study, all of whom will receive avonex. patients will join the study by signing the attached informed consent form (appendix 1) at their doctor's office at the time of prescription. innomar will provide the drug to approximately 40 new patients per month, so it will take about twelve to fourteen months to enroll all of the study subjects, assuming that all agree to participate. once the recruitment period is over, it will take another 22 months to complete the study to the 22-months point for the last subject. in the retrospective arm of the study, 500 chart reviews will be completed for patients who had participated in the ms alliance program two (2) to three (3) years ago to determine persistence to therapy over a similar 22 month period. study objectives primary objectives: - to assess patients' compliance (as defined above) with avonex therapy in the prospective arm using self-reported patients questionnaire, as well as to compare patients' persistence on therapy (as defined above) between prospective and retrospective arms. secondary objective: - evaluate patients' satisfaction with new msa program. patients and methods only patients enrolled in the msa program will be included in this study. there will be no interventions above the current standard of care with the msa program. two distinct patient arms will exist for this study: the prospective arm and the retrospective (chart review) arm. inclusion criteria * diagnosed with relapsing remitting multiple sclerosis (rrms) * prescription of avonex® ps (prefilled syringes) * enrolment in the ms alliancetm program

Eligibility criteria:
inclusion criteria: * diagnosed with relapsing remitting multiple sclerosis (rrms) * prescription of avonex® ps (prefilled syringes) * enrolment in the ms alliancetm program
results of usage of bridging plate in multi-fragmentary distal radius fracture

Conditions: Distal Radius Fractures; Mechanical Complication of Internal Rod Fixation Device; Internal Fixation; Complications

Summary: using a plate as a distraction method bridging the comminution to restore anatomical parameters to treat comminuted distal radius fracture follow-up functional outcomes of the wrist after metal removal

the plate is extended from the floor of the 2end extensor compartment at an intact radius to the 2end metacarpal by dual minimally invasive skin incisions. one distal over 2end metacarpal and other proximal over 2end extensor compartment at intact radius application of distal screws 1st, then the traction is done to restore radial length, radial inclination, and volar tilt followed by the application of proximal screws add wires to restore the joint congruity wire removal after 45 days, plate removal after 100 day follow up every 3 months till 1 year post-operative assess the functional outcome of the wrist joint after metal removal

Eligibility criteria:
inclusion criteria: 1. skeletally mature patients 2. presented with multifragmentary distal radius fractures classify type 23-3c according to ao classification 3. articular with or without metaphyseal comminution 4. very distal fractures 5 )osteoporotic bone fractures exclusion criteria: 1. dorsal soft tissue defect or tendon injuries 2. metacarpal fractures (esp 2end mc) 3. open grade 3 fractures

Keywords: bridging plate, distraction plate
evaluation of psychological status in pregnant women complaining of hypertension with pregnancy

Conditions: Hypertension With Pregnancy

Summary: this study is a case controlled study comparing mental health status and some psychological impacts between two groups of patients first group is pregnant women without any other medical disorder during pregnancy,the second group is pregnant women complaining of hypertension with pregnancy.


Eligibility criteria:
inclusion criteria: * pregnant women * hypertensive pregnant women for diseased group * normal pregnancy with no medical disorders associated in controlled group * singleton pregnancy * spontaneous pregnancy * patients who are not divorced or not widow exclusion criteria: * non-pregnant women * any other associated medical disorder with pregnancy rather than hypertension * any known psychological or mental disorder prior to pregnancy * non spontaneous pregnancy as those whom conceived by ivf * twin or more pregnancy * patients who are divorced or widow

Keywords: hypertension with pregnancy anxiety depression preeclampsia mental health
non-interventional study of ziprasidone in the treatment of bipolar and schizoaffective disorders.

Conditions: Affective Psychosis, Bipolar; Mania; Manic-Depressive Psychosis

Summary: assessment of ziprasidone safety and efficacy in the treatment of bipolar and schizoaffective disorders.

method: consecutive patient sampling. patients were included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Eligibility criteria:
inclusion criteria: * manic and mixed episodes of up to moderate severity in patients with type i and ii bipolar disorder and schizoaffective disorder; either first diagnosed or repeated episodes exclusion criteria: * hypersensitivity to ziprasidone * prolonged qtc interval * coadministration with substances that are prolonging the qtc interval * recent acute mi, cardiac failure, patients with arrhythmias treated with class ia or iii medicaments

Keywords: safety of ziprasidone, efficacy of ziprasidone, manic episodes in bipolar disorder, mixed episodes in bipolar disorder, schizoaffective disorder.
peanut oral induction tolerance in peanut's allergic teenagers

Conditions: Peanut Allergy

Summary: the primary purpose of the protocol is to evaluate the efficacy of a protocol for induction of tolerance to peanut ingestion increasing doses. the secondary purpose is to determine the interest of a prolonged maintenance therapy

prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance

Eligibility criteria:
inclusion criteria: * adolescents between 12 and 18 years * clinical history of allergic manifestation within one hour of ingestion of peanuts or double-blind, placebo-controlled food challenges (dbpcfcs) peanut positive below the threshold of 2 grams * bad reaction peanut demonstrated by positive patch test (pt ≥ 3 mm above the negative control) and specific ige f13\> 12 iu / ml and / or rara h2\> 5.8 iu / ml * previous follow at least 1 year exclusion criteria: * lack of response during the initial dbpcfcs to the cumulative dose of 2 grams of peanut or instant dose of 1 gram of peanut * uncontrolled asthma and / or severe over the previous year * atopic dermatitis uncontrolled * initial severe anaphylaxis requiring hospitalization in intensive care * presence of a major allergy with anaphylaxis at another allergen risk (milk, egg, nuts, or other) * home away from a center could support a severe reaction in emergency * lack of motivation and understanding of parents and / or child * incapacity * to establish a daily logbook of clinical monitoring * to support severe reaction after eating peanut * to follow a regular peanut ingestion protocol

Keywords: teenager peanut oit (oral induction tolerance)
screening test accuracy of gynocular™, hr-hpv testing, via for detection of cervical neoplastic lesions, in women living with hiv

Conditions: Uterine Cervical Neoplasms; HIV/AIDS

Summary: cervical cancer in hiv-positive women is largely preventable through regular screening. the world health organization (who) recommends cervical screening for hiv-positive women every three years. currently the least costly method for screening and the most viable option for many countries is visual inspection after application of acetic acid (via). alternative testing methods are hpv testing and assessment with a portable magnification device. the investigators plan to assess and compare the screening test accuracy of these screening tests in women living with hiv. all women will receive histopathology reference standard.

the simplest and least costly method for cervical cancer screening is visual inspection after application of acetic acid (via). however, the ability of this screening method to correctly identify precancerous lesions (sensitivity) and women free from these lesions (specificity) is limited. the investigators aim to identify alternative screening methods which maximize sensitivity and specificity, particularly in hiv-infected women in receiving care in southern africa. the investigators will evaluate the screening test accuracy of a new portable magnification device , the gynocular™ with swede score assessment, in women who are hiv-positive and eligible for cervical cancer screening. the investigators will assess the accuracy of the device when used as a stand alone test, as well as when used subsequent to positive via or hpv tests. the investigators will make comparisons with current screening practices (via alone), as well as, recommended screening practices (hpv testing). the investigators will enrol 450 hiv-positive women receiving care for hiv/aids at the centre for infectious disease research in zambia, in lusaka, zambia. consenting women will be screened with via, hpv testing and visual assessment with gynocular™. all women undergo biopsy (reference standard) and receive treatment as indicated and in accordance with national guidelines.

Eligibility criteria:
inclusion criteria: 1. hiv-infected women confirmed through medical records 2. women residing within lusaka district and plans to stay in this area for the next 6 months 3. women between 18 and 65 years of age (age bracket as per zambian guidelines for cervical cancer screening) 4. able and willing to consent 5. willing to undergo a pelvic examination and cancer screening 6. has had sexual intercourse before 7. agrees to have follow-up appointment in 6 months exclusion criteria: 1. women with a history of cervical cancer or previous hysterectomy (where the cervix was also removed) 2. pregnant women or women who plan to get pregnant within the next 6 months 3. women who have been vaccinated against hr-hpv
sti prophylaxis and emergence of antimicrobial resistance

Conditions: Sexually Transmitted Infection (STI) Prevention; Antibiotic Prophylaxis; Antibiotic Resistance, Bacterial; Microbiome; Doxycycline

Summary: the goal of this observational study is to understand the risk of antibiotic resistance and changes in the human microbiome (bacteria that live inside and on us), if people use antibiotics to prevent sexually transmitted infections (sti prophylaxis, doxycycline post-exposure prophylaxis, or 'doxypep'). the study will assess how easy and acceptable it is to find antibiotic resistance and microbiome changes in the throats and guts of men-who-have-sex-with-men (msm) who use sti prophylaxis. the study will recruit 108 msm who are using and not using sti prophylaxis. participants will visit the clinic every 6 months. at each visit, they will provide a throat swab and stool sample, and complete a questionnaire. dna of the bacteria from the samples will be analysed to identify the bacteria and look for antibiotic resistance.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years. * identifies as a man (cis or trans). * has sex with men. * able to provide informed consent. exclusion criteria: * use of an antibiotic other than doxycycline in the 3 months prior to enrolment * currently being treated for an sti with doxycycline * use of doxycycline within the prior 3 months for an indication other than sti treatment or sti prevention.

Keywords: doxypep sti prophylaxis doxycycline sti prevention antimicrobial resistance antibiotic resistance microbiome men-who-have-sex-with-men
effectiveness and implementation of the assessment of burden of chronic conditions (abcc)-tool

Conditions: Chronic Obstructive Pulmonary Disease; Asthma; Diabetes Mellitus, Type 2; Heart Failure

Summary: this study is designed to evaluate the effectiveness and implementation of the assessment of burden of chronic conditions (abcc)-tool for patients with copd, asthma, diabetes mellitus type 2 or heart failure (and any combination of these conditions) in real-life routine practice. the abcc-tool consists of a questionnaire, a visualisation using balloons that is based on cut-off points, and treatment advice. the abcc-tool is intended to be used in daily healthcare practice, is designed to monitor a patient's integrated health status over time, to facilitate shared decision making, and to stimulate self-management. the study has a pragmatic clustered quasi-experimental design with two arms. the intervention group will use the abcc-tool and the control group will receive usual care. the study will be implemented at a general practice-level, and has a follow-up period of 18 months. the primary outcome is change in perceived quality of care, as measured with the patient assessment of chronic illness care (pacic), as compared to usual care after 18 months. it is hypothesized that the change in perceived quality of care is significantly higher in the group using the abcc-tool as compared to the group that receives usual care. additionally the implementation of the abcc-tool in general practices will be evaluated in 12 general practices. the implementation study will evaluate the context of caregivers with the consolidated framework for implementation research, the process of implementation with the re-aim framework, and fidelity to the intervention with the fidelity framework.


Eligibility criteria:
inclusion criteria: * diagnosis copd, asthma, diabetes mellitus type 2 and/or heart failure * can understand and read the dutch language exclusion criteria: * copd or asthma: used prednisone due to an exacerbation less than six weeks ago * heart failure or diabetes mellitus type 2: hospitalized less than six weeks ago * healthcare providers or patients who have already used the assessment of burden of copd-tool are excluded from the control group * patients who have already used the assessment of burden of copd-tool will be excluded from the intervention group
study of nitazoxanide (ntz) for helicobacter pylori in children

Conditions: Helicobacter Pylori Infection

Summary: study of nitazoxanide (ntz) based therapeutic regimens for helicobacter pylori in children

study of novel triple nitazoxanide (ntz) based new therapeutic regimens for helicobacter pylori in children

Eligibility criteria:
inclusion criteria: - positive helicobacter infection. exclusion criteria: * previous treatment for h. pylori.
covid-19 soliris expanded access protocol

Conditions: Covid19

Summary: this protocol provides participants with covid-19 access to soliris.

this is an open-label, multicenter, expanded access protocol that will provide access to soliris for participants diagnosed with severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection with a clinical presentation consistent with covid-19 associated organ injury, such as acute respiratory distress syndrome, stroke, or acute renal failure. participants who qualify for emergency treatment (whether in an inpatient or outpatient setting) will be offered the opportunity to receive up to 7 infusions of soliris over approximately 4 weeks.

Eligibility criteria:
inclusion criteria: 1. males or females ≥ 18 years of age and body weight ≥ 40 kg. 2. confirmed diagnosis of sars-cov-2 infection by any method used by the institution (eg, via reverse transcriptase polymerase chain reaction and/or antibody test). 3. willing to receive vaccination against neisseria meningitidis and prophylactic antibiotics against meningococcal infections if the participant has not been vaccinated within 5 years prior to day 1. 4. in the opinion of the investigator, the participant is suitable to be enrolled in the expanded access protocol (eap), based on the participant's overall clinical condition and the known soliris benefit/risk profile. exclusion criteria: 1. unresolved neisseria meningitidis infection. 2. known hypersensitivity to murine proteins or to an excipient of soliris.

Keywords: soliris eculizumab c5 inhibitor covid-19 sars-cov-2 acute lung injury severe pneumonia acute respiratory distress syndrome severe acute respiratory syndrome coronavirus 2 severe acute respiratory syndrome multi-organ injury hospitalization antibodies, monoclonal, humanized emergency treatment viral expanded access
safety & tolerability of mts in children aged 6-12 diagnosed with adhd & previously treated with extended-release methylphenidate therapy

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this study will assess the safety and tolerability of mts while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

attention-deficit/hyperactivity disorder (adhd) is a psychiatric disorder characterized by 3 main symptoms: inattention, hyperactivity and impulsivity. this study will assess the safety and tolerability of spd485 while attempting to establish the appropriate starting dose for subjects previously on an existing long-acting methylphenidate product.

Eligibility criteria:
inclusion criteria: * subject must have a primary diagnosis of adhd * subject must be adequately controlled on a stable dose of one of the following medications for a 30 day period: ritalin la(r), concerta(r), or metadate dc(r), not to exceed 54 mg per day * females of childbearing potential must have a negative serum beta human chorionic gonadotropin pregnancy test exclusion criteria: * a history of mental retardation that would indicate that the subject is not functioning at an age appropriate level intellectually * a recent history of suspected substance abuse or dependence disorder * subject is taking strattera * clinical signs and symptoms of skin irritation or hyper/hypopigmentation at the potential application sites
effect of 3g versus 2 g mmf in combination with tacrolimus on progression of renal allograft interstitial fibrosis

Conditions: Kidney Transplantation; Kidney Failure

Summary: development of chronic changes (scarring) in transplanted kidney tissue is a major cause of long-term kidney function deterioration and ultimately graft loss. it results from both immunologic and non-immunologic mechanisms. mycophenolate mofetil (mmf) is immunosuppressive drug used for prevention of rejection after kidney transplant, usually in combination with a calcineurin inhibitor (tacrolimus or cyclosporine), with or without corticosteroids. besides immunosuppression, mmf may also have direct antifibrotic properties. tacrolimus has potent immunosuppressive effects and is the cornerstone of contemporary posttransplant immunosuppressive therapy in kidney recipients. however, it is also nephrotoxic. the hypothesis of the present study is that in the setting of similar net immunosuppression, higher dose of mmf (3 g daily) will result in slower progression of kidney fibrosis during first year posttransplant as compared to mmf 2 g daily. to test this hypothesis, the present study will randomly assign low immunological risk kidney transplant recipients to either 2g or 3 g mmf daily, in combination with tacrolimus, with, or without maintenance steroids. all patients will have kidney biopsy at implantation and at 12 months after transplantation. main outcome will be 1-year change in chronic kidney histology (interstitial fibrosis) assessed by protocol biopsy.


Eligibility criteria:
inclusion criteria: 1. first kidney or kidney-pancreas transplantation 2. cdc pra \<=20% exclusion criteria: 1. dual kidney transplantation 2. ab0 incompatible transplantation 3. 0 biopsy ci, ct, cv, or ah score \>=2

Keywords: kidney transplantation chronic allograft dysfunction mycophenolate mofetil chronic
cough reflex and obstructive sleep apnea syndrome

Conditions: Sleep Apnea Syndrome

Summary: up to 70% of obese patients undergoing bariatric surgery have obstructive sleep apnea syndrome (osas). osas is responsible for laryngeal sensory impairment. as the afferent neural pathway involved in the initiation of cough is located in the laryngeal epithelium, cough reflex sensitivity may be decreased in obese osas patients. the researchers therefore conducted this study to determine the effect of osas associated with obesity on cough reflex sensitivity, assessed by cough reflex threshold to an inhaled irritant (citric acid).

obese patients undergoing scheduled bariatric surgery underwent a cough challenge as part of their routine preoperative evaluation. patients were classified as presenting osas if apnea-hypopnea index obtained from preoperative full-night polysomnography was greater than 5/hour. cough threshold was measured with citric acid. increasing concentrations of mouth- nebulized citric acid (2.5, 5, 10, 20, 40, 80, 160, 320 and 640 mg/ml) were delivered during inspiration until a cough was elicited. the citric acid concentration eliciting one cough (c1) was defined as the cough reflex threshold.

Eligibility criteria:
inclusion criteria: * obese patient scheduled to undergo bariatric surgery exclusion criteria: * age less than 18 * active smoking * psychotropic medication * angiotensin-converting enzyme inhibitor or angiotensin ii receptor antagonist medication * pregnancy * anesthesia or endotracheal intubation during the previous month * allergic rhinitis * upper airway or bronchopulmonary infection during the previous month * chronic cough * chronic respiratory disease * pharyngolaryngeal disease * neurological disease

Keywords: cough reflex citric acid obesity sleep apnea syndrome