Kornimate/medical-research-clean huggingface dataset:
use of introduction mode to improve interactive voice response surveys in bangladesh and tanzania

Conditions: Surveys and Questionnaires; Noncommunicable Diseases

Summary: this study evaluates the effect of two different introduction modes on interactive voice response (ivr) survey cooperation, response, refusal, and contact rates, in bangladesh and tanzania.

using random digit dialing (rdd) sampling techniques, participants were randomized to one of two introduction modes, followed by a noncommunicable disease (ncd) risk factor survey. the two modes were computer assisted telephone interview (cati), in which a call-center employee read the introduction to a participant and received oral consent from them, before sending them the ncd risk factor survey via ivr, or the entire survey, including the introduction and consent, being obtained via ivr. in ivr surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. if you are male, press 1; if you are female, press 2). this study was conducted in both bangladesh and tanzania.

Eligibility criteria:
inclusion criteria: * access to a mobile phone * greater or equal to 18 years of age * in bangladesh, conversant in either english or bangla language. in uganda, conversant in either luo, luganda, runyakitara, or english languages. exclusion criteria: * less than 18 years of age

Keywords: mobile phone surveys interactive voice response computer-assisted telephone interviews introduction mode
influenza vaccination and copd phenotypes

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the aim of this study is to determine responses of the immune system to the annual flu vaccination in people with copd who experience frequent or infrequent exacerbations and healthy participants. we will collect blood and saliva immediately before and one month after flu vaccination at gp surgeries in the autumn/winter period. by measuring how quickly antibodies (that provide protection against infection) develop in the blood after vaccination we can provide important new information to help confirm whether those prone to copd flare ups have weaker immune systems.


Eligibility criteria:
inclusion criteria: patients aged 65-85 years with a diagnosis of copd (according to global initiative for chronic obstructive lung disease criteria: post bronchodilator fev1/fvc ratio \<0.70) and moderate to severe airflow limitation (fev1 30-80% predicted) who opt to receive the annual influenza vaccine. we will also include healthy participants aged 65-85 years without symptoms of lung disease who opt to receive the annual influenza vaccine. exclusion criteria: * unable/unwilling to provide informed consent * any history of allergies, suspected hypersensitivity and/or contraindication to vaccines (e.g egg protein allergy) * participation in another clinical trial (use of investigational product or device) * not on optimal treatment (copd patients only) * current smokers, exhaled co \>10 parts per million * clinical instability, defined as experiencing a copd exacerbation less than 4 weeks prior to baseline visit, as indicated by treatment with systemic glucocorticosteroids and/or antibiotics and/or hospitalization (copd only) * an upper/lower respiratory tract infection e.g. common cold, sinus symptoms, pneumonia, which has not resolved four weeks prior to baseline visit * diagnosis of asthma and/or other relevant lung disease (e.g. history of primary or clinically significant bronchiectases, cystic fibrosis, bronchiolitis, lung resection, lung cancer, interstitial lung disease \[e.g. fibrosis, silicosis, sarcoidosis\], active tuberculosis) * known alpha-1-antitrypsin deficiency * immunological diseases or known infection with human immunodeficiency virus (hiv) * any diagnosis of a malignant disease (other than basal or squamous cell carcinoma) in the last 5 years * currently taking immunosuppressive medications * diagnosis of diabetes mellitus * severe renal failure (calculated egfr less than 60 ml/min) * liver impairment child-pugh b/c and/or active viral hepatitis * severe psychiatric or neurological disorders (parkinson's disease or motor neurone disease) * planned donation of human tissue (blood, organs or bone marrow) during the course of the trial

Keywords: influenza exacerbations
evaluation of pet ct in the management of patients with crohn's disease.

Conditions: Crohn's Disease

Summary: 18f-fdg pet/ct (2-\[fluorine-18\] fluoro-2-deoxy-d-glucose, positron emission tomography- ct) is a noninvasive technique that allows quantifying and precisely localizing 18f-fdg uptake in the entire body. 18f-fdg uptake is caused by increased local metabolic activity. such increased uptake has been described not only in neoplastic lesions but also in inflammatory lesions. in this condition, uptake has been correlated with local stimulation of tumor necrosis factor, and with monocyte priming and activation. a physiologic variable uptake may be observed in the bowel, especially the cecum, and has limited the use of pet in inflammatory bowel diseases. the advantage of combined pet and ct devices lead to significant improvements in the interpretation of the bowel areas, and greatly reduces the number of false-positive findings in the gastrointestinal tract.


Eligibility criteria:
inclusion criteria: * patients suspicious for active disease: * patients with suspected but undiagnosed crohn's disease * patients with serological markers of inflammation (elevated esr, crp or thrombocytosis) but clinically in remission * patients with a stricture which might be fibrous in which case surgery is indicated or inflammatory for which medical management is indicated * able to sign a consent form exclusion criteria: * pregnancy * breastfeeding * infectious colitis determined at the initial checkup * allergy to iodine contrast

Keywords: crohn's disease
gametocytocidal and transmission-blocking efficacy of asaq and alaq with or without pq in mali

Conditions: Malaria,Falciparum

Summary: the purpose of this study is to compare the gametocytocidal and transmission reducing activity of artesunate-amodiaquine (asaq) and artemether-lumefantrine-amodiaquine (alaq) with and without a single dose of 0.25mg/kg primaquine (pq). outcome measures will include infectivity to mosquitoes at 2, 7 and 14 days after treatment, gametocyte density throughout follow-up, and safety measures including haemoglobin density and the frequency of adverse events.

full protocol available on request

Eligibility criteria:
inclusion criteria: * age ≥ 10 years and ≤ 50 years * absence of symptomatic falciparum malaria, defined by fever on enrolment * presence of p. falciparum gametocytes on thick blood film at a density \>16 gametocytes/µl (i.e. ≥ gametocytes recorded in the thick film against 500 white blood cells) * absence of other non-p. falciparum species on blood film * haemoglobin ≥ 10 g/dl * individuals weighing \< = 80 kg * no evidence of acute severe or chronic disease * written, informed consent exclusion criteria: * women who are pregnant or lactating (tested at baseline). urine and/or serum pregnancy testing (β-hcg) will be used. * detection of a non-p. falciparum species by microscopy * previous reaction to study drugs / known allergy to study drugs, such as sudden high fevers, shaking or severe sore throat or ulcers in the mouth during treatment with amodiaquine * current eye disease with retinal damage * signs of severe malaria, including hyperparasitaemia (defined as asexual parasitaemia \> 100,000 parasites / µl) * signs of acute or chronic illness, including hepatitis * the use of other medication (except for paracetamol and/or aspirin), including antacids, other medicines used to treat malaria, abnormal heart rhythm, depression or mental illness or hiv/aids, and medicines that have antibiotic/antifungal properties * use of antimalarial drugs over the past 7 days (as reported by the participant) * clinically significant illness (intercurrent illness e.g., pneumonia, pre-existing condition e.g., renal disease or hiv/aids, malignancy or conditions that may affect absorption of study medication e.g., severe diarrhoea or any signs of malnutrition as defined clinically) * signs of hepatic injury (such as nausea and/or abdominal pain associated with jaundice) or known severe liver disease (i.e., decompensated cirrhosis, child pugh stage b or c) * signs, symptoms or known renal impairment * clinically significant abnormal laboratory values as determined by history, physical examination, or routine blood chemistries and haematology values (laboratory guideline values for exclusion are haemoglobin \ 2.0mg/dl, or alt more than 3 times the upper limit of normal for age. * blood transfusion in the last 90 days. * known electrocardiogram (ecg) corrected qt interval of more than 450 ms * documented or self-reported history of cardiac conduction problems * documented or self-reported history of epileptic seizures
laparoscopic pectopexy and laparoscopic colporrhaphies in pelvic organ prolapse treatment

Conditions: Vaginal Vault Prolapse; Uterine Prolapse; Cystocele, Midline; Rectocele; Female

Summary: this prospective cohort study investigates the surgical outcomes of laparoscopic pectopexy and laparoscopic colporraphy performed at the wellbeing services county of south ostrobothnia. the primary outcome measure is to assess changes in sensation of bulge and pressure. secondary outcome measures include evaluating other prolapse symptoms and pain, quality of life, anatomical correction of prolapse, surgical safety parameters, and postoperative complications. approximately 40-50 laparoscopic pectopexies will be performed over two years by a single experienced surgeon. the study requires preoperative and postoperative assessments, including standardized patient questionnaires and anatomical measurements.

the study aims to evaluate the effects of laparoscopic pectopexy and colporraphy on pelvic organ prolapse (pop) symptoms, anatomical prolapse repair, and surgical outcomes. the primary outcome measure is the presence of a bulging sensation 12 months after surgery. secondary outcome measure includes additional prolapse-related symptoms, residual urine volume, pelvic pain, urinary incontinence, and safety parameters such as intraoperative blood loss and complications. anatomical correction will be assessed using the pelvic organ prolapse quantification (pop-q) system. all surgical procedures will be performed by a single experienced surgeon with over five years of experience and more than 100 laparoscopic pectopexies performed. patients will undergo laparoscopic pectopexy, with or without concomitant anterior and posterior vaginal wall repair using sutures. the pectopexy procedure utilizes a 3x15 cm dynamesh prp pvdf mesh, secured with absorbable monofilament thread to the vaginal cuff or with non-absorbable multifilament sutures to the uterine cervical stump.

Eligibility criteria:
inclusion criteria: * symptomatic pelvic organ prolapse * uterine or vaginal vault prolapse reaching the hymenal ring (pop-q classification: ≥0 cm) * if uterus in situ, consent for supracervical hysterectomy * suitable for laparoscopic mesh surgery * age: 18-79 years * non-pregnant, no pregnancy desire. * sufficient finnish language skills * concurrent anterior and/or posterior prolapse repair if pop-q criteria met: tvl \>8 cm and aa, ba, ap, bp ≥0 exclusion criteria: * unwillingness to undergo surgery or mesh implantation * high anesthetic or surgical risk due to comorbidities * indication for laparoscopic sacrocolporectopexy due to rectal intussusception * desire to preserve the uterus * pregnancy or planning future pregnancy * inability to understand finnish or study-related forms due to cognitive impairments * need for concomitant urinary incontinence surgery

Keywords: laparoscopic pectopexy laparoscopic colporraphy
patient decision aid for antidepressant use in pregnancy

Conditions: Depression; Pregnancy

Summary: the proposed study is a pilot randomized controlled trial (rct) of an electronic patient decision aid (pda) for antidepressant use in pregnancy. the overall aim of this pilot rct is to establish the feasibility of future large international rct of the pda's effectiveness.

depression in pregnancy is common, affecting up to 10% of women and represents serious risk to mother and infant. unfortunately, antidepressant medication, a first-line treatment for depression in pregnancy, also comes with risks, making this a complex decision. clinical care appears to be insufficient for ensuring that women make decisions that are consistent with their own values and with which they feel satisfied. patient decision support tools can address such barriers. canadian colleagues have created a patient decision aid (pda) that has the potential to improve the decision-making process for women regarding antidepressant use in pregnancy in conjunction with clinical care. this study is a pilot rct of the above pda in london, to be conducted in parallel with a pilot rct in toronto.the overall objective of this project is to inform the development of a larger, international rct to assess the efficacy of this pda for antidepressant use in pregnancy. to achieve this objective, the investigators will assess the feasibility of the trial protocol to evaluate the pda and determine the preliminary effect size for a larger multisite efficacy study. the primary outcome for this pilot study is the feasibility of conducting a large randomized controlled trial to evaluate the efficacy of the pda. this includes feasibility (how well the trial protocol can be implemented), acceptability (usability and tolerability of the intervention) and adherence (the degree to which the trial protocol is followed). it is hypothesized that the protocol will be feasible, that the pda will have a high degree of acceptability, and that adherence to the protocol will be high.

Eligibility criteria:
inclusion criteria: women who meet all of the following criteria: * are aged over 18 * are planning a pregnancy or are \<30 weeks pregnant at enrolment * have been offered to start or continue an antidepressant as treatment for depression by their clinician a * have moderate-to-high decisional conflict (score of \>25 on the decisional conflict scale) exclusion criteria: women who meet any of the following criteria: * have had alcohol or drug abuse or dependence in the previous 12 months * have active suicidal ideation or psychosis * are incapable of consenting to participation * have any major obstetric complications or foetal cardiac anomaly in the current or in a past pregnancy, * are visually impaired * do not have sufficient english language proficiency to use the pda.
social forces to improve statin adherence (study a)

Conditions: Medication Adherence; High Blood Pressure; Diabetes

Summary: to assess the effectiveness of reporting statin adherence patterns to a medication adherence partner (map) in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle. hypothesis: subjects with a map receiving daily adherence feedback will have the highest statin adherence of any arm, as measured by pill bottle data.

we propose to complete a randomized controlled trial (rct) of 200 subjects with medication treated diabetes and evidence of poor adherence to a statin medication (\ 2 consecutive daily doses of statin; and 4) usual care (glowcaps without any notifications). the primary outcome will be the percent of statin doses taken during the study as measured by the glowcaps. the secondary outcome will be subjects' statin medication possession ratio (mpr) during the study.

Eligibility criteria:
inclusion criteria: * the subject is humana insured * the subject is an english speaking adult * age range ≥18 years * the subject has diagnosis with diabetes for ≥12 months * the subject has an mpr \<70% to a statin medication * subject denies side-effects to their statin medication * the subject identified a person who agreed to serve as their map exclusion criteria: * the subject is \<18 years old * the subject is considered part of a vulnerable population (is a prisoner, a cognitively impaired person, or a pregnant woman) * on statin combination medication * the subject does not identify an individual who agrees to serve as their map * the subject reports a clinically important side effect to the statin medication or active liver disease:

Keywords: medication adherence high blood pressure diabetes statins
the multimedia hiv/sti prevention for drug-involved female offenders

Conditions: HIV; Sexually Transmitted Infections

Summary: the proposed study addresses a significant public health threat of human immunodeficiency virus (hiv) and sexually transmitted infections (stis) among drug involved women on probation, parole or other community supervision. this randomized controlled trial aims to test the efficacy of a multimedia version of a 4-session, gender-specific, integrated drug use and hiv/sti prevention intervention (multimedia women on the road to health (worth)) in increasing condom use and decreasing the incidence of sexually transmitted infections (stis) among 420 drug-involved, female offenders in a large community court setting in new york city, compared to a non-media version of the same intervention (traditional worth) and to a 4-session wellness promotion condition.

while it is clear that women inmates in jails and prisons bear a high burden of human immunodeficiency virus/acquired immunodeficiency syndrome (hiv/aids), the effective development of prevention interventions for this high-risk group require an understanding of hiv risk context, sexual behaviors and attitudes for women while they are still in the community and before they become heavily involved in the criminal justice system. hiv prevention interventions must focus on women at early points of entry into the criminal justice system, when they are still in the community and at higher risk of engaging in unsafe sex and drug behaviors. this study focuses on a population of drug-involved women who have been arrested and given a court sanction, but are still living in the community.

Eligibility criteria:
inclusion criteria: * she is 18 or older. * she is currently supervised by a criminal justice entity, such as a community court or probation. * she reports engaging in unprotected vaginal or anal sex with a male partner in the past 90 days * she reports any illicit drug use or binge drinking in the past 6 months. exclusion criteria:in addition, potential participants will be ineligible if any of the following criteria are met: * ability to speak and understand english is not sufficient to participate in assessments or intervention sessions. * the woman's sexual activity is limited to a monogamous relationship lasting more than 12 months, and she has not engaged in any of the additional hiv risk behaviors in the past 90 days: * having sex with more than one partner * having sex with a partner known or suspected to be hiv positive or an injection drug user (idu) * sharing injection drug use needles or equipment * the woman is actively trying to get pregnant/have a baby. * inability to complete informed consent process due to a psychiatric or cognitive impairment. * the participant was born male.

Keywords: hiv stis condom use criminal justice drug use
percutaneous tibial nerve stimulation in the treatment of fecal incontinence

Conditions: Fecal Incontinence

Summary: background of the study: fecal incontinence is a complex problem. the social consequences of this problem result in a lower quality of life. the exact prevalence of fi is unknown, literature reports vary from 13-19%. there are variable treatment options depending on the patient and the etiology of the fi. dietary manipulation, pharmacological intervention, pelvic floor physiotherapy, as well as surgical interventions are currently used to treat fi. a promising current treatment is percutaneous tibial nerve stimulation (ptns). the nerves in the spine that control bowel function also have branches which go to the ankle. stimulating these nerves in the ankle has shown to be an effective treatment for fi in the short-term. the treatment has been shown to be safe and well tolerated by subjects with almost no morbidity in prior urology trials. objective of the study: the objective of this study is to show that the results of ptns are based on the treatment of electrical stimulation and not on a placebo effect with a sham treatment. study design: this study is a multicenter, single-blinded, randomized, placebo-controlled trial. primary study parameters/outcome of the study: the percentage of patients experiencing a ≥ 50% decrease in incontinence episodes from baseline after 9 weeks of treatment. secondary study parameters/outcome of the study (if applicable): mean change in the cleveland clinic florida fecal incontinence score (ccf-fi score) mean change in quality of life scores in validated qol questionnaires (sf-36, digestive health status instrument (dhsi), and fecal incontinence quality of life) subject's and physician's global impression


Eligibility criteria:
inclusion criteria: * written informed consent * must be at least 18 years of age * fecal incontinence with solid or liquid stool causing disruption of the subject's lifestyle * psychological stability as determined by treating physician * willingness to commit to a rigid follow-up schedule and comply with the investigational plan * failed conservative therapy (i.e. dietary and behavioural modification, biofeedback techniques and exercises for pelvic floor muscle retraining) * during treatment the patient exhibits an adequate motor and/or sensory response (flexion of toe and/or twinkling sensation) * is able to read and write exclusion criteria: * major internal and/or external sphincter defect (defined as \>33% of the anal circumference) * fecal impaction * pacemaker, implanted defibrillator * pregnancy or intention to become pregnant * neurogenic or congenital disorders resulting in fi * inability to travel to the clinic twice a week

Keywords: fecal incontinence