Kornimate/medical-research-clean huggingface dataset:
the effect of obesity on pregnancy and fetal outcome in glucose tolerant mothers

Conditions: Obesity

Summary: the participants are divided into subjects or controls based on the bmi taken during the first trimester of pregnancy upon recruitment. participants with a bmi of ≥23kg/m2 were recruited as subjects (labelled as obese group) and those with bmi of 18.5-23kg/m2 were recruited as controls. total gestational weight gain was calculated based on the difference between third trimester weight and first trimester weight. all participants who fulfilled the inclusion and exclusion criteria were recruited after informed consent. demographic data of all participants were recorded. at first trimester, the participants' weight and height were recorded for calculation of bmi. at every trimester visit, the following were recorded: i) blood pressure using sphygmomanometer after 15 minutes of rest ii) mid-stream urine for presence of proteinuria iii) weight. the participants were followed up until the point of delivery. occurrence of adverse pregnancy outcome, fetal outcome, and birth weight were documented. the pregnancy outcomes measured in this study included the need of primary caesarian section, the occurrence of pregnancy-induced hypertension (pih), pre-eclampsia, and gestational age at delivery. the neonatal outcomes measured in this study included neonatal intensive care unit (nicu) admission, stillbirth, preterm delivery, occurrence of macrosomia and low birth weight, and neonatal birth weight.


Eligibility criteria:
inclusion criteria: * first trimester of pregnancy * aged 18 years or older * able to come for follow up at least once per trimester exclusion criteria: * underlying diabetes mellitus * gestational diabetes mellitus diagnosed via ogtt * known genetic disorders affecting growth at time of recruitment * known congenital anomalies at time of recruitment * conceived via artificial insemination * hepatitis b/c/hiv infection
comparison of continuous and pulsatile apomorphine in parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to compare the effects of apomorphine, given by two different methods, to determine how best to manage dyskinesias.

levodopa is a drug that can be taken by mouth, and improves the symptoms of parkinson's disease (pd). however it can eventually cause involuntary movements called dyskinesia and motor fluctuations-fluctuations in the control of symptoms, often referred to as "off" and "on." apomorphine is a drug that works as well as levodopa, but does not work if taken by mouth. the purpose of this study is to compare the effects of apomorphine in people with pd who have levodopa-induced motor fluctuations and dyskinesias. in the trial, researchers will compare the effects of apomorphine administered by subcutaneous bolus injections (pulsatile) and by ambulatory infusion pumps (continuous) in 24 people with pd, for 6 months. after an initial screening, potential participants will undergo a test to verify that they can tolerate and respond to apomorphine. those who meet all of the requirements will be randomized to receive the study drug via injections (shots) using an injector pen or a portable infusion pump. apomorphine will be given either continuously using the portable pump during the waking day or intermittently by injection, for 6 months. the pump will be carried on a belt and connected by a tube to a small needle under the skin. injections of apomorphine under the skin will be self-administered by the participants or administered by friends or family members using injector pens. after 6 months, the effects of apomorphine use will be assessed by measuring how the participants respond to levodopa and by measuring their symptoms during the course of the study. participants will be followed initially every week, then biweekly, and then monthly in an outpatient clinic for 6 months. during this time, they may receive adjustments of apomorphine doses as well as doses of other antiparkinson medications.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease * clear response to levodopa (sinemet) * "off" at least 20% of waking day * dyskinesias present for at least two hours of waking day * subject or caregiver able to master use of drug delivery system (injector pen or pump) exclusion criteria: * physical complications that would preclude safe participation * standing systolic bp of \<80 * lack of tolerance or response to apomorphine * drug/alcohol abuse

Keywords: parkinson's disease pd pulsatile apomorphine dyskinesia apomorphine continuous dopaminergic stimulation
does detailed informed consent for cardiopulmonary resuscitation and mechanical ventilation impact patients' decisions and outcomes?

Conditions: Congestive Heart Failure; Infections; Sepsis; Acute Renal Failure; Stroke

Summary: there is evidence to suggest that patients make different end-of-life decisions if they understand the risks, benefits and alternatives of cpr and mechanical ventilation. this study will examine whether evidence-based informed consent impacts patients choices and healthcare outcomes compared to routine care.


Eligibility criteria:
inclusion criteria: * all patients * ≥65 yrs * admitted to the hospitalist medicine service exclusion criteria: * patients who have pre-existing, pan-institutional (e.g. to be applied at nursing homes and hospitals) orders of no cpr and/or no mechanical ventilation will be screened (demographic and outcomes data collected) but not randomized. * patients already receiving critical care on admission will also be excluded
the da vinci single port robotic system for use in abdominal and pelvic surgical procedures

Conditions: Disease or Disorder

Summary: this phase ii trial test the effectiveness and safety of a single-port robotic device (the da vinci single port \[sp\]1098) for use in abdominal and pelvic surgeries. the da vinci sp1098 robotic device can be used to perform less invasive surgeries that allow entry into the body through a single, small incision. the use of this device during surgery may allow surgeons to perform complex procedures that result in less pain, fewer complications and side effects, and improved recovery.

primary objective: i. to evaluate the effectiveness and safety for abdominal and pelvic procedures of a single-port robotic device (da vinci sp1098) that is food and drug administration (fda)-approved for other indications, specifically urological and transoral otolaryngology surgical procedures. outline: patients undergo surgery using the da vinci sp1098 robotic system on study.

Eligibility criteria:
inclusion criteria: * documented informed consent of the participant and/or legally authorized representative * any patient scheduled to undergo robot-assisted abdominal or pelvic procedures * age \> 18 years exclusion criteria: * body mass index (bmi) \> 45 * contraindications to minimally invasive surgery including chronic obstructive pulmonary disorders * past history of failed attempt of minimally invasive abdominal or pelvic surgery
a proof-of-concept study to assess batoclimab in participants with graves' disease

Conditions: Graves Disease

Summary: the purpose of this study is to assess the efficacy and safety of 24 weeks of treatment with batoclimab in adult participants with biochemically documented hyperthyroidism due to gd who have failed to achieve euthyroidism on antithyroid drugs (atds).


Eligibility criteria:
inclusion criteria: * have serologically confirmed gd as documented by presence of elevated stimulatory thyrotropin receptor antibody (tsh-r-ab) level (i.e., \> specimen-to-reference ratio of 140%) at the screening visit. * have active hyperthyroidism due to gd with the following laboratory values at the screening visit: * tsh \< lln * ft3 \> upper limit of normal (uln) and \<=5 \* uln * ft4 \> uln and \<=5 \* uln note: participants who have t3 thyrotoxicosis (i.e tsh \ uln and ≤5× uln, but ft4 within normal range) at the screening visit may be enrolled, if they have serologically confirmed gd as per inclusion criterion 1. * are willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule. exclusion criteria: * history of hyperthyroidism not caused by gd (e.g., toxic adenoma or toxic multinodular goiter), and/or history or presence of thyroid storm. * history of treatment with radioactive iodine or thyroid surgery. * total immunoglobulin g (igg) level \<6 grams per liter (g/l) at the screening visit. * albumin level \<3.5 grams per deciliter (g/dl) (\<35 g/l) at the screening visit. * absolute neutrophil count \<1000 cells per cubic millimeter (cells/mm\^3) at the screening visit. other, more specific exclusion criteria are defined in the protocol.

Keywords: graves' disease imvt-1401 batoclimab hyperthyroidism
dose-ranging study of tofacitinib in adults with active ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this is the first study of oral tofacitinib in adults with active ankylosing spondylitis. it is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.


Eligibility criteria:
inclusion criteria: * documented diagnosis of ankylosing spondylitis * has active disease despite concurrent nonsteroidal anti-inflammatory drugs (nsaids) treatment or is intolerant to nsaids exclusion criteria: * pregnant or lactating females * currently receiving or previous use of a tumor necrosis factor (tnf) inhibitor or any biological agent

Keywords: ankylosing spondylitis spondylitis ankylosing spondyloarthritis spondyloarthropathy oral preparation
study of pan-90806 eye drops, suspension for neovascular amd

Conditions: Neovascular Age-related Macular Degeneration

Summary: double-masked, uncontrolled, multi-center, study in which participants will be randomized to one of 3 doses of topical ocular pan 90806 administered once daily for 12 weeks.

patients with newly diagnosed, active, pathologic cnv associated with neovascular amd will be screened for inclusion into the study after providing written informed consent. participants who are eligible for the study will be centrally randomized at day 1 to one of three doses of pan-90806 eye drops. participants will be instructed to apply one drop of pan-90806 to the ocular surface of the identified study eye once daily for twelve (12) weeks. participants will return for follow-up visits at week 2, week 4, week 8, week 12, 1 week after stopping pan-90806 treatment and 1 month after stopping pan-90806 treatment.

Eligibility criteria:
inclusion criteria: * diagnosis in the study eye of active, pathologic, newly diagnosed and previously untreated, subfoveal choroidal neovascular (cnv) lesions secondary to neovascular amd * aged 50 years or older * demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye exclusion criteria: * prior ocular or systemic treatment or surgery for neovascular amd in the study eye * prior use within the last 3 months or a high possibility of requiring treatment with anti-vegf therapy in the fellow eye during the study * significant retinal serous pigment epithelial detachment (ped), atrophy, or fibrosis/scar involving the fovea * history of or current clinical evidence in the study eye of aphakia, diabetic macular edema, any ocular inflammation or infections, pathological myopia, retinal detachment, advanced glaucoma, and/or significant media opacity, including cataract * history or evidence of the following surgeries in the study eye: penetrating keratoplasty or vitrectomy; corneal transplant; corneal or intraocular surgery within 3 months of screening * uncontrolled hypertension despite use of antihypertensive medications * participation in any investigational drug or device study, systemic or ocular, within past 3 months * women who are pregnant or nursing * women of child-bearing potential who are not using a highly effective form of birth control * known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the pan-90806 formulation

Keywords: amd wet amd exudative amd macular degeneration
hormone replacement therapy (hrt) website tool

Conditions: Communication; Menopause; Hormone Replacement Therapy

Summary: the purpose of this study is to evaluate a prototype web-based module for patients to generate appropriate and focused health information along with a customized set of questions to take to their health care provider for discussion on hormone replacement therapy.

patient-centered care may be enhanced by medically accurate, personalized health information generated by specialized software on the internet. this study assessed the effect of a web-based interactive tool about menopausal hormone therapy (ht) on patient and provider communication and satisfaction. the controlled, randomized evaluation of the talktoyourdoc(sm) (ttyd) interactive website module on communication, satisfaction and efficiency of office visits involved 288 women born between 1930 and 1960 and 26 health care providers in an outpatient, academic setting. women were randomized after stratification by ht use to usual care or access to the ttyd website. the ttyd website built a personalized series of questions based on participant input regarding health status and generated a printout of health issues, medications and questions about ht for participants to bring to the visit with their health care provider. results of the study found that women who participated in the intervention were more likely to come prepared to the clinic appointment with appropriate questions (80% vs. 96%) than women receiving usual care. participants found the website easy to use, the questions generated were useful in the discussion of ht, and they felt that providers had a positive response to the printout. providers felt that women who participated in the intervention were more engaged in the discussion and asked more relevant questions regarding ht. providers had a higher level of satisfaction with the discussion with intervention participants, and felt that these office visits were more efficient. therefore, it was determined that the talktoyourdoc(sm) module enhanced communication between women and their providers, led to greater visit satisfaction for both patient and provider, and improved visit efficiency.

Eligibility criteria:
inclusion criteria: * women born between 1930 to 1960 * scheduled appointment at the ob/gyn or family and community medicine out-patient clinics between 11/9/2004 to 12/2/2005 exclusion criteria: * men * current pregnancy * diagnosed cancer
effects of gabapentin in the treatment of neuropathic pain on driving performance and cognition

Conditions: Chronic Neuropathic Pain

Summary: the aim of this study was to explore the effects of pain on the one hand and the effects of treatment of pain with gabapentin (900, 1200, 1800 or 2400 mg) on the other hand on actual driving performance and several laboratory tests in patients with neuropathic pain. it was hypothesized that gabapentin might influence performance after acute but not after subchronic administration.

numerous studies demonstrate neuropsychological impairment in patients with chronic pain, particularely on measures assessing attentional capacity, processing speed and psychomotor speed. about 50% of the patients suffering from neuropathic pain are treated with anticonvulsants, as a treatment against serious pain complaints, and experience good pain relief. gabapentin is one of the most prescribed anticonvulsants for the treatment of neuropathic pain. an important disadvantage of treatment with gabapentin could be the occurrence of side effects, such as somnolence and fatigue. these side effects can constitute a crucial problem for patients treated with gabapentin who must operate a motor vehicle or other dangerous machinery. however, pain affects cognition negatively, and possibly also driving. therefore, another possibility is that treatment with gabapentin for these pain complaints can improve driving because the pain has less influence. since driving is an activity of daily living that is important in maintaining independency in the community, such as access to employment and social activities, it is important to establish the effects of using gabapentin on these abilities. no studies have been conducted so far to investigate driving abilities of patients with neuropathic pain, treated with gabapentin.the aim of this study was to explore the effects of pain on the one hand and the effects of acute (day 1) and subchronic (day 15) treatment of pain with gabapentin (900, 1200, 1800 or 2400 mg) on the other hand on actual driving performance and several laboratory tests in patients with neuropathic pain. it was hypothesized that gabapentin might influence performance after acute but not after subchronic administration. this study is a two-period double-blind, placebo-controlled, cross-over randomised study.

Eligibility criteria:
inclusion criteria: * age, responder to gabapentin,succesfully treated with gabapentin at least 4 weeks before start of study, minimal vas pain intensity scores of 4 cm on a 10 cm scale, driving licence, driving experience, fluently speaking dutch, normal vision, right-handed exclusion criteria: * alcohol- or drug dependence, use of other psychotropic medication, use of illicit drugs, psychological or physical disorder other than pain or pain-related, excessive smoking and drinking

Keywords: gabapentin neuropathic pain driving attention
effects of inspiratory muscle training in chronic obstructive pulmonary disease (copd)

Conditions: COPD; Inspiratory Muscle Weakness

Summary: the additional effect of inspiratory muscle training as an adjunct to a general exercise training program in patients with copd with inspiratory muscle weakness will be studied. the main hypothesis is that inspiratory muscle training combined with an exercise training program improves functional exercise capacity more than an exercise training program without the addition of an inspiratory muscle training program.


Eligibility criteria:
inclusion criteria: * patients with copd * eligible to participate in an inpatient pulmonary rehabilitation program of 3 weeks * pi,max \<60 centimeters of water or \<50% of the predicted normal value exclusion criteria: * major comorbidities preventing successful participation in an 8 week exercise training intervention * use of non-invasive ventilation
examining the effect of ondansetron on bowel prep success

Conditions: Abdominal Pain; Inflammatory Bowel Diseases; Eosinophilic Gastroenteritis; Diarrhea; Hematochezia; Weight Loss

Summary: this is a pilot randomized-controlled trial assessing the utility of ondansetron for improving pediatric pre-colonoscopy bowel prep outcomes using the boston bowel preparation score, as well as assessing the impact on patient experience of bowel preparation.

the study will compare two approaches to pre-colonoscopy cleanout, one with traditional laxatives only, and one with laxatives + anti-emetic therapy. the medication to be added will be ondansetron (brand name: zofran). classically, the bowel prep entails drinking large amounts of water with an osmotic laxative and being only on a liquid diet the day prior to the procedure. drinking this mixture of water with an osmotic laxative may cause nausea and discomfort in some patients that may prevent them from finishing the bowel prep. this will therefore affect the visualization of the colon during the procedure, as there will still be retained, hard stool. having large amounts of stool in the colon during the procedure can make the colonoscopy more difficult, takes a longer time to complete, can make the study inconclusive, unable to properly diagnose, and difficult to take biopsies. this study assesses the impact of anti-emetic medication (ondansetron) on the bowel prep experience with the goal of improving participant tolerance and preparation success. this will eliminate concern for retained stool and less chance of cancelling a procedure due to improper bowel prep.

Eligibility criteria:
inclusion criteria: * age \>2, \<20 * clinically indicated for a colonoscopy exclusion criteria: * known arrhythmia or long qt

Keywords: colonoscopy bowel preparation ondansetron
diagnostic validity of the neurodynamic or orthopedic tension tests

Conditions: Radiculopathy, Lumbosacral Region

Summary: the objective of the present study is to analyse the diagnostic validity of 8 neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the gold standard.

lumbar radiculopathy is a nerve root disorder which affects quality of life of the patient and it is considered as an important health problem. therefore, its correct diagnosis is essential. the objective of the present study is to analyse the diagnostic validity of 8 neurodynamic and/or orthopedic tension tests using magnetic resonance imaging as the gold standard. this is an epidemiological study of randomized consecutive cases which was observational, descriptive, transversal, double blinded and followed the stard (standards for reporting diagnostic accuracy studies) declaration.

Eligibility criteria:
inclusion criteria: * clinical suspicion of lumbar or lumbosacral radiculopathy exclusion criteria: * healthy subjects or with a radiculopathy already diagnosed * subjects with diabetes, alcoholism, hiv+, herpes zoster infection, cancer, multiple sclerosis, hereditary neuropathy or lumbar surgery * persons with pacemaker or stent * known pregnancy * persons that refused to participate in the study or undergo the mri scan.

Keywords: lumbar radiculopathy neurodynamic tension tests orthopaedic tension tests lumbosacral radiculopathy
randomized controlled trial of shunt vs etv/cpc for pih in ugandan infants

Conditions: Hydrocephalus

Summary: two treatment options exist for infant patients with hydrocephalus. most patients are treated with a surgical procedure in which a shunt is inserted into the brain and abdomen. in recent years, however, another treatment has developed called endoscopic third ventriculostomy (etv) with choroid plexus cauterization (etv/cpc).this research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or pih. this study will evaluate patients in more detail to measure brain growth and development.

world over, infants with hydrocephalus are mainly treated using a shunt, which is a device made of soft plastic tubing that moves extra fluid from the brain to the abdomen. surgery is required to insert a shunt into the brain and the abdomen. in recent years, we have developed another treatment called endoscopic third ventriculostomy (etv) with choroid plexus cauterization (etv/cpc). this research study is being done to measure the results of these procedures in children less than six months of age who have hydrocephalus as the result of a brain infection, called post-infectious hydrocephalus, or pih. this is the most common cause of hydrocephalus in ugandan babies. this study will evaluate patients in more detail to measure brain growth and development. children in the study will have special testing to measure developmental progress as well as special imaging to evaluate the progress of their brain growth.

Eligibility criteria:
inclusion criteria: * infants less than 180 days (six months) old * symptomatic hydrocephalus * post-infectious hydrocephalus based on clinical and ct parameters2 * must be from the following ugandan districts: bugiri, busia, iganga, jinja, kampala, kamuli, kapchorwa, katakwi, kumi, mayuge, mbale, mukono, pallisa, sironko, soroti, and tororo exclusion criteria: * any patient with a scalp erosion or infection that would exclude the patient from shunt implantation * any patient with ventricular loculations that would normally indicate the use of ventriculoscopy as an adjunct to shunt placement * any patient with absence of any visible cortical mantle on the ct * patients must be appropriate candidates for either surgical procedure - shunt placement alone or etv/cpc