Kornimate/medical-research-clean huggingface dataset:
prevalence of osteoporosis in sickle cell disease

Conditions: Sickle Cell Disease

Summary: sickle cell disease is the most common single-gene disease in the world. its prevalence is increasing in france, with patients' life expectancy increasing into developed countries. it mainly affects populations originating from sub-saharan africa. among the chronic bone complications associated with sickle cell disease, osteoporosis has previously been highlighted but remains a poorly known complication in this very particular context. a dedicated evaluation of osteoporosis and associated risk factors in sickle cell disease patients living in france may enable better bone management of these patients in the future, as this problem, specific to their disease, is likely to become more frequent as their life expectancy increases. this is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteoporosis in black patients with sickle cell disease in france


Eligibility criteria:
inclusion criteria: * black-skinned men and women * aged 20 to 40 years old * sickle cell patients * non-opposition to participate in the study exclusion criteria: * refusal to participate in the study * hemoglobinopathy other than sickle cell disease * severe or end stage renal failure * long-term corticosteroid therapy (\>3 months) * history of solid cancer or malignant haemopathy * history of organ transplantation * pregnant or breastfeeding woman * psychiatric pathology seriously impeding understanding * difficulty understanding oral french

Keywords: sickle cell disease
optimising protection for pregnant women and infants with maternal vaccination

Conditions: Obesity

Summary: this study has been designed to investigate if: 1. bmi affects the immunogenicity of influenza and pertussis vaccines given during pregnancy. 2. if pertussis vaccine co-administered with influenza vaccine impacts on the immunogenicity of the influenza vaccine. 3. if bmi affects transplacental antibody transfer efficiency following maternal vaccinations.

a clinical observation study to determine whether obesity during pregnancy is associated with altered immunogenicity of influenza and pertussis vaccines during pregnancy. the study will also assess vaccine specific antibody concentrations in cord blood collected from vaccinated women at the time of delivery to estimate any effect of obesity on transplacental transfer of antibodies and will measure and compare cytokine profiles between obese and non-obese participants to determine any correlation with immune responses. this study will enrol 150 pregnant women (50 obese and 100 non-obese) during 2017-2019 to receive a recommended, licensed influenza vaccine (fluquadri) as well as pertussis vaccination (adacel) for women enrolled in their third trimester, as part of routine antenatal care. local and systemic adverse events will be captured using a 7 day diary card and unexpected or serious adverse events will be recorded for the duration of the study. blood samples will be collected to measure antigen specific vaccine antibody responses. the proportion of influenza vaccine recipients achieving seroprotective antibody titres at 4 weeks post vaccination and persisting at 6 months post vaccination be compared between obese and non-obese recipients.

Eligibility criteria:
inclusion criteria: * participants who, in the opinion of the study staff, can and will comply with the requirements of the protocol (eg. return for follow-up visits, blood collection etc). * pregnant women aged 18 years and over at the time of vaccination. * able to understand the information sheet and provide a written informed consent. exclusion criteria: * any major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study, or interfere with the evaluation of the study objectives. * history of serious medical conditions (eg cardiac, respiratory, renal, hepatic disorders, diabetes requiring treatment with insulin). * history of seasonal influenza or dtpa vaccination within the last 6 months prior to enrolment. * history of any immunosuppressive condition or currently on immunosuppressive medication. * any contraindication to influenza or dtpa immunisation. * anaphylaxis following a previous dose of any influenza or pertussis containing vaccine. * history of anaphylaxis to egg. * past history of guillain barre syndrome. * bleeding diathesis or condition associated with prolonged bleeding that may contraindicate intramuscular injection or blood draw. * receipt of immunoglobulins, blood or blood products within the past 6 months.

Keywords: obesity vaccination pregnancy influenza pertussis maternal antibodies
post-market randomized trial: endoscopically- guided ablation vs. radiofrequency ablation

Conditions: Paroxysmal Atrial Fibrillation

Summary: to compare the safety and chronic pulmonary vein isolation of 2 ablation types. 1. visually guided ablation (vga) using the eas-ac and 2. radiofrequency ablation

the goal of the study was to compare two interventions, visually-guided endoscopic ablation to standard-of-care radiofrequency (rf) ablation. the study was terminated early by the sponsor for business reasons before any participants were randomized or treated with rf ablation.

Eligibility criteria:
* symptomatic, paroxysmal atrial fibrillation (af) * 18 to 75 years of age * generally good overall health as determined by multiple criteria * willing to participate in a study * others

Keywords: atrial fibrillation
a study of nivolumab by itself or nivolumab combined with ipilimumab in patients with advanced or metastatic solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: to investigate the safety and efficacy of nivolumab as a single agent or in combination with ipilimumab in 6 tumor types - triple-negative breast cancer (tnbc), gastric cancer (gc), pancreatic adenocarcinoma (pc), small cell lung cancer (sclc), bladder cancer (bc), and ovarian cancer (oc). a combination of nivolumab with ipilimumab and cobimetinib is also investigated in pc.

all tumor types are now closed for enrollment: triple negative breast cancer gastric cancer pancreatic cancer small cell lung cancer bladder cancer ovarian cancer

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subjects with histologically or cytologically confirmed locally advanced or metastatic disease of the following tumor types: * triple negative breast cancer * gastric cancer * pancreatic cancer * small cell lung cancer * bladder cancer * ovarian cancer * subjects must have measurable disease * eastern cooperative oncology group (ecog) of 0 or 1 * adequate hematological and organ function as confirmed by laboratory values exclusion criteria: * active brain metastases or leptomeningeal metastases * subjects with active, known or suspected autoimmune disease * subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment * prior therapy with experimental anti-tumor vaccines; any t cell co-stimulation or checkpoint pathways, such as anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-ctla-4 antibody, including ipilimumab; or other medicines specifically targeting t cell is also prohibited
reliability of kinovea in gait assessment in multiple sclerosis: a pilot study.

Conditions: Multiple Sclerosis; Gait Disorders, Neurologic

Summary: the objective of this observational study is to determine whether the kinovea video analysis tool is valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis, comparing the data obtained from this system with those of the gold standard, the gaitrite system. the main question to be answered is: is the kinovea system valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis? participants walked across the gaitrite platform four times without shoes and four times with shoes, while being recorded by two cameras simultaneously: one recorded gait from the sagittal plane and the other from the frontal plane.


Eligibility criteria:
inclusion criteria: * patients scheduled for evaluation by the neurolab-lázaro gait laboratory (seville). * patients who have signed informed consent prior to the test. * patients between 18 and 55 years of age, diagnosed with ms according to the 2017 mcdonald criteria. * patients with an edss score of less than 6.5 points. * patients who are willing to participate in the study and who do not object to being recorded while performing the gait test and to the use of images for educational and research purposes. exclusion criteria: * patients who use walking aids and/or orthoses. * patients with comorbidity or decompensated systemic disease within the last month. * patients who have any physical impediment (excessive fatigue) to performing the gait test, as documented in their medical records reviewed on the diraya platform. * patients who have suffered a relapse within 30 days prior to the start of the study.

Keywords: multiple sclerosis gait disorders, neurologic kinovea gaitrite
a pilot study examining the efficacy of biomodulator treatment for chronic low back pain

Conditions: Chronic Low Back Pain

Summary: the purpose of this study is to determine the efficacy of self treatment with the biomodulator device to decrease chronic low back pain (lbp) in active duty service members. in addition, the study will track the use of pain medication and the impact of pain on symptoms of anxiety, depression and post traumatic stress syndrome (ptsd).


Eligibility criteria:
inclusion criteria: * active duty service members (sms) between the ages of 18 and 62, inclusive * history of chronic lbp (i.e. intermittent or continuous lbp symptoms present for 3 months or greater prior to entry into the study * participants must be using narcotic and/or non-narcotic oral analgesic medications to treat their chronic lbp symptoms on a weekly basis * must be able to speak and read english and understand the study procedures exclusion criteria: * pacemaker or implanted electronic device * history of stroke, blood clots, or cardiac arrhythmias * pregnancy * no self-reported history of prescription medication abuse or sole-provider contract for prescribed narcotic medications * open wound over site of chronic pain; * history of spinal surgery * participation in a clinical trial for an investigational drug/ treatment within last 30 days * undergone treatment with tens, biofeedback, or acupuncture within last 30 days * prior treatment with the biomodulator * lbp "red flags": fever, trauma, progressive motor or sensory deficit, saddle anesthesia * participation in the study would delay the medical board (meb) processing of the service member off of active duty status or would delay a return to duty status to their home unit

Keywords: back pain chronic
dietary fatty acids improve social impairment in autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: in a double-blind, placebo-controlled 16-week trial investigators administered daily doses of either youths with autism spectrum disorders.ara and dha supplementation significantly improved communication as well as social withdrawal symptoms. this pilot study provides the first evidence that supplementation with larger ara doses added to dha improve impaired social interaction in youths with autism spectrum disorders (asd).

we recruited 13 individuals who met the dsm-iv criteria for a diagnosis of high functioning autistic disorder (n=1) or asperger's disorder (n=12),corroborated by the autism diagnostic interview-revised. participants were free of any medical or comorbid psychiatric disorders. other inclusion criteria included weigh of at least 16 kg, either a verbal or performance intelligence quotient (iq) above 80, and a score greater than 10 on the social withdrawal subscale of the aberrant behavior checklist-community.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of high functioning autistic disorder or asperger's disorder. free of any medical or comorbid psychiatric disorders. exclusion criteria: * any medical treatment for other psychiatric disorders

Keywords: arachidonic acid autism spectrum disorders social interaction randomized controlled trial dha
functionality of lower limbs in patients who have undergone knee meniscectomy

Conditions: Meniscectomy Sequelae

Summary: introduction. meniscal lesions are common and are associated with the development of osteoarthritis of the knee. work activities that cause mechanical stress can lead to acute or chronic injuries. the surgical treatment for this injury is meniscectomy. physiotherapy is a widely accepted first-line treatment for patients with meniscus tears. objective. to assess the clinical and functional status of patients who have undergone meniscus surgery with and without post-surgical physiotherapy. material and method. multicenter ambispective cohort study. 89 patients who have undergone meniscectomy will be recruited. the primary variable of the study will be functionality (time up \& go), with the prescription of a post-surgical physiotherapy treatment being the dependent variable. the secondary variables, estimated as modifying or confounding, will be range of motion (goniometry), pain intensity (visual analog scale) and kinesiophobia (tampa scale).


Eligibility criteria:
inclusion criteria: * persons aged 20 to 65 * of both sexes * with previous meniscectomy surgery in one of the two knees in the last 5 years * who sign the informed consent document. exclusion criteria: * patients who require technical aids for walking * dependent patients for carrying out activities of daily living * patients over 65 years of age * patients with cognitive impairments that prevent understanding of tests and evaluations

Keywords: knee meniscectomy functionality range of movement pain intensity kinesiophobia
cannabinoids, neural synchrony, and information processing

Conditions: Cannabis; Psychotic Disorders

Summary: the study examines the effects of delta-9-tetrahydrocannabinol (δ9-thc), the principal active ingredient of cannabis, on neural synchrony. neural synchrony is studied using electroencephalography (eeg).


Eligibility criteria:
inclusion criteria: * men and women aged 18 and 55 years (extremes included) on the day of the first dosing. * exposed to cannabis at least once. exclusion criteria: 1. cannabis naïve 2. positive pregnancy screen during screening 3. hearing deficits
the role of thyroid function in the development and prognosis of stanford type a aortic dissection.

Conditions: Stanford Type A Aortic Dissection

Summary: a total of 300 consecutive cardiac patients will receive preoperative thyroid function profile evaluation, including 150 patients with standford type a aortic dissection (staad) and 150 normal human.for one thing, we will compare the two groups and study the role of thyroid function in the develoment of staad. for another, we will collect all the perioperative data of the staad group and study the role of thyroid function in the prognosis of staad.


Eligibility criteria:
inclusion criteria: adult patients with staad will underwent aortic surgery who are willing and able to give informed consent for participation in the study. exclusion criteria: the main initial exclusion criteria included clinical evidence of sepsis or cachexia or concomitant presence of any predominant severe systemic disease.
anogenital wart burden and cost of illnesses

Conditions: Warts

Summary: the study will be a prospective study of patients presenting with anogenital warts. the objective are to assess proportion of anogenital warts to the total number of sexual transmitted infection patients, to quantify direct and indirect cost of illnesses and psychological burden associated with anogenital warts and to estimate government program expenditure for the prevention and control and treatment of the sti/anogenital hpv infection.

an observational study, multiple visit, 2-center study will be conducted in rajavithi general hospital, and bangrak hospital. one hundred and fifty subjects will be enrolled from both hospitals. anogenital wart patients presented in rajavithi general hospital and the sti clinic at bangrak hospital will be recruited prospectively. all patients will be treated according to standard medical guidelines or usual care of the institutes. after the baseline assessment, the patients will have follow up visits with their physicians and will also be interviewed at the clinical sites three time approximately at day 7 (-2+7 days), month 1 (+-7 days), and month 6 (+-7 days) until they are cure. at month 6 (+-14 days), telephone assessment for the capture of any signs of disease recurrence will be done. all patients will be followed for 6 months under the same schedule.

Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older and has anogenital warts * physician confirmed clinical diagnosis of anogenital warts * subject is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent * subject will be available for the study follow up period exclusion criteria: * subject is unable to give informed consent * subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives such as other concurrent/active sti
dynamic balance training in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study will test a new technique for improving balance while walking in people with multiple sclerosis (ms). the technique focuses on having people with ms safely practice walking on simulated, uneven terrain that challenges balance and more accurately mimics walking in the community. the goal is to improve balance while walking in order to improve mobility and decrease the risk of falls. recently, we developed a state-of-the-art treadmill system that allows us to create a challenging walking environment by placing a treadmill onto a motion base. we are able to simulate uneven terrain through movements of the walking surface while maintaining a safe walking environment. we will use this system to conduct tests of balance while walking and to train people to walk on uneven surfaces. our objective is to evaluate the use of uneven terrain for training gait and balance in people with ms. participants will undergo a four-week training protocol designed to disrupt and challenge balance while walking. we anticipate that training on uneven terrain will enhance gait stability, improve overall walking function and balance and increase balance confidence compared to training on a stable surface.


Eligibility criteria:
inclusion criteria: * participants have been clinically diagnosed with multiple sclerosis * must be capable of walking 10 meters independently with no physical assistance * must be able to ascend/descend a small staircase (5 steps) * medically stable * able to give informed consent exclusion criteria: * they suffer from cognitive deficits that prevent them from following 1 step commands * unable to give informed consent * if they suffer from significant cardiovascular problems, respiratory failure, major orthopedic problems, or other medical conditions that affect balance (e.g. diabetic neuropathy, myopathy, or vertigo) * significant medical comorbidity or concurrent illness limiting their capacity to conform to study requirements
thalidomide in treating patients with chronic graft-versus-host disease following bone marrow transplant

Conditions: Graft Versus Host Disease; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific

Summary: rationale: thalidomide may interfere with the body's ability to recognize transplanted bone marrow cells as foreign and may help treat patients with graft-versus-host disease. purpose: randomized phase ii trial to study the effectiveness of thalidomide in treating patients who have chronic graft-versus-host disease following bone marrow transplantation.

objectives: i. determine the efficacy of thalidomide in patients with steroid dependent or refractory chronic graft vs host disease following an allogeneic bone marrow transplant. ii. determine the toxicity of this regimen in these patients. outline: this is a randomized study. patients are stratified according to the type of bone marrow transplant received (allogeneic vs matched unrelated donor) and type of chronic graft vs host disease (steroid dependent vs steroid refractory). patients receive either oral thalidomide or placebo 2-4 times a day for 6 months. the drug is then tapered until stopped. if disease recurs, the drug may be restarted for a second 6 month course. the maximum duration of treatment is 18 months. patients continue on steroid therapy, which is tapered during study therapy. if no response is seen after 8 weeks, patients may cross over to the other alternate drug. patients are followed weekly for 1 month, then every month for 1 year. projected accrual: a total of 36 patients (18 per arm) will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed chronic graft vs host disease following an allogeneic bone marrow transplant (bmt) greater than 100 days since bmt must be receiving at least 1 mg/kg of prednisone or equivalent immunosuppression patient characteristics: age: 3 and over performance status: not specified life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: not pregnant fertile patients must use effective contraception prior concurrent therapy: biologic therapy: see disease characteristics chemotherapy: not specified endocrine therapy: see disease characteristics radiotherapy: not specified surgery: not specified

Keywords: unspecified childhood solid tumor, protocol specific unspecified adult solid tumor, protocol specific graft versus host disease
the impact of short message services (sms) on arv adherence in western kenya

Conditions: AIDS; Antiretroviral Therapy; Medication Adherence; HIV Infections

Summary: the purpose of proposed research is to implement a randomized study that will allow us to understand and address a number of key barriers to patient adherence as well as study the effects of better adherence on health and socio-economic outcomes.

several studies have shown that proper adherence to treatment regimens is essential for the effectiveness of arv therapy (e.g wools-kaloustian et al. 2006). there is also evidence in that in some treatment programs in africa, adherence rates are not always high (gill et al. 2005). even in settings where adherence levels are found to be high, numerous factors have been identified as being relevant, although the causal effects are unknown (castro, 2006). as arv treatment programs are scaled up in africa, it is essential to understand the socio-economic determinants of adherence to arv treatment, as well as the impact of interventions to support high levels of adherence. a secondary objective of this study is to understand the socio-economic impacts of higher adherence.

Eligibility criteria:
inclusion criteria: * patients who had been on arv therapy at the chulaimbo rural health center for a maximum of three months and providing consent to participate in the study. exclusion criteria: * patients who had been on arv therapy for more than 3 months.

Keywords: mobile phones, medication adherence micro-electrical-mechanical systems hiv infections