Kornimate/medical-research-clean huggingface dataset:
a safety and efficacy study of agn-214868 in patients with postherpetic neuralgia

Conditions: Neuralgia, Postherpetic

Summary: this is a safety and efficacy study of agn-214868 in patients with postherpetic neuralgia (phn).


Eligibility criteria:
inclusion criteria: * postherpetic neuralgia with pain present for at least 9 months exclusion criteria: * active herpes zoster skin rash * anticipated treatment for postherpetic neuralgia during the first 3 months of the study, including oral and topical medications, acupuncture, spinal cord stimulation, transcutaneous nerve stimulation (tns), or trigger point injection * anticipated treatment with pain medication for the treatment of postherpetic neuralgia during the first 3 months of the study * use of capsaicin treatment for postherpetic neuralgia within 6 months, or anticipated use during the first 3 months of the study * use of botulinum toxin of any serotype for any reason within 6 months, or anticipated use during the study
effects of probiotic capsules in promoting fat excretion by human trial

Conditions: Obesity

Summary: the purpose of this study was to evaluate the efficacy of 2 capsules (500 mg per capsule, 1000 mg per day) of grape king probiotic capsules per day in promoting fat excretion in obese patients by clinical human food test.

this experiment is carried out in a controlled manner. before the subjects enter the research experiment, they need to follow their original lifestyle. the habits of maintaining a constant body weight for more than 2 weeks before the test, such as calorie balance in the diet and the amount of activity. then enter the test to carry out the evaluation test of probiotics to the end. 60 subjects were randomized, 20 to placebo and 40 to probiotics. the subjects took two capsules of grape king probiotics daily, a total of 1000 mg. continue to take it for 4 weeks, and perform blood routine tests. body composition detection, waist and hip circumference measurement, related index analysis and 24-hour dietary questionnaires, gut health questionnaires and stool samples were collected and analyzed for 4 weeks before and after treatment.

Eligibility criteria:
inclusion criteria: * male or female participants * aged 20-40 years old * body mass index in 25-27 kg/m2 * body fat \> 25% for men and \> 30% for women exclusion criteria: * cancer, chronic heart disease, use drugs which pharmacological effects may affect immunity * having systemic infections * using probiotics.
follow-up of serum androgen profile after bariatric surgery in men with obesity related hypogonadotropic hypogonadism

Conditions: Morbid Obesity; Hypogonadism

Summary: the purpose of this study is to determine the natural course of the androgen profile after bariatric surgery in men with obesity related hypogonadotropic hypogonadism.


Eligibility criteria:
inclusion criteria: * male * age 20-55 years * planned bariatric procedure * helicobacter pylori negative or adequate hp eradication exclusion criteria: * liver and/or kidney dysfunction * psychiatric disease * medication influencing androgen profile and/or bone metabolism * weight \> 160 kg

Keywords: hypogonadotropic hypogonadism bariatric surgery serum androgen levels bone density
european multi-center post market study of the ibv valve system

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the objective of this randomized, blinded, multicenter, controlled study is to compare the performance of the ibv valve system (treatment group) to a control group receiving a sham bronchoscopy procedure without valve placement.

the ibv valve system (spiration inc. redmond, wa) has ce mark approval for the treatment of diseased and damaged lung. the devices are one-way valves that can be placed in the airways via flexible bronchoscopy limiting airflow distally. for the treatment of emphysema, valves are placed in airways communicating to the most diseased areas of lung tissue to re-direct airflow to less diseased areas. a multicenter, blinded and randomized study of these valves is being conducted in 7 centers in 6 european countries. the study is evaluating the effectiveness of this therapy for the treatment of upper lobe predominant emphysema in patients with severe to very severe emphysema (gold classification 3 to 4) that despite best medical management continue having poor quality of life, severe symptoms and physical limitations. the primary endpoints are to measure and compare responses using the st. george's respiratory questionnaire and lung volume changes as measured by ct-scans. consented patients that meet the strict inclusion criteria have a bronchoscopic procedure and are randomized into treatment or control (no valves) groups. after the procedure, all patients stay blinded to their group assignment and have follow-up evaluations at 1 and 3 months. after the 3-month evaluation, each patient is un-blinded. the treatment group is then scheduled for an additional follow-up at 6 months and the control group is offered valve treatment (rollover) and evaluated approximately 3 months later.

Eligibility criteria:
inclusion criteria: * between 40 and 74 years of age * predominantly upper lobe emphysema and severe dyspnea * satisfies the criteria of the ats/ers guidelines for management of stable copd * physical ability to participate in the study by performing a 6-minute walk distance of \> 140m * no cigarette smoking for 4 months and willing to abstain throughout the study * severe airflow obstruction defined by fev1 45% of predicted * severe hyperinflation defined by: tlc \> 100% of predicted and rv \> 150% of predicted exclusion criteria: * between 70 and 74 years of age and an fev1 or dlco \< 20% of predicted * severe gas exchange abnormalities * major medical disease that will limit evaluation, participation or follow-up * active asthma component to their disease * giant bulla (\> 1/3 volume of lung) * severe pulmonary hypertension * requirement for \> 6l02 to keep saturation \> 90% with exercise * evidence of systemic disease or neoplasia expected to compromise survival during the 6-month study period

Keywords: copd emphysema bronchoscopic treatment interventional bronchoscopy
validation of osmolarity system: clinical usability study

Conditions: Dry Eye

Summary: confirmatory trial to validate usability of a new portable osmolarity testing device.

confirmatory trial at 3 sites in canada to validate usability of an ocular osmolarity testing device.

Eligibility criteria:
inclusion criteria: * able to provide consent exclusion criteria: * ocular pathology (other than dry eye)
oscillatory activity in basal ganglia circuits during normal and pathological movement

Conditions: Parkinson Disease; Epilepsy

Summary: the expression of hypokinetic and hyperkinetic motor symptoms is accompanied by pathological synchronous oscillations of neuronal activity in this cortico-subcortical network with a wide frequency range. the purpose of this research is to study cortico-subcortical oscillations and their synchronization in two pathologies emblematic of hypokinetic (parkinson's disease) and hyperkinetic (epilepsies) phenomena using a simple motor task and comparing different situations.

in order to define the link between the characteristics of the oscillations (frequency, amplitude, phase relation) within this cortico-subcortical network and movement (normal or pathological) in humans, a simple motor task of gripping/pulling a lever has been designed. the local field potentials (lfps) will be collected during the same motor task in : i) patients with parkinson's disease, using a high-resolution electroencephalogram (eeg) and the percept(tm) system (medtronic) equipped with a "sensing" function for deep lfp recordings and in eeg-hr (for high resolution) for cortical recordings ii) patients with focal drug-resistant epilepsy, during a pre-surgical assessment by stereo-electro-encephalography (seeg). the seeg allows the recording of both the cortex and the subcortical regions in a concomitant manner, and a direct correlation can be studied.

Eligibility criteria:
inclusion criteria : * male or female * between 18 and 75 years of age * with parkinson's disease and already operated with implantation of electrodes in the subthalamic nucleus connected to a percept (tm) device. * giving free, informed, written consent signed by the participant and the investigator or * with drug-resistant epilepsy and benefiting from a phase ii pre-surgical assessment with intracerebral electrophysiological exploration by stereo-eeg * with at least one electrode exploring the basal ganglia or the thalamus. * able to perform the simple motor task * affiliated or beneficiary of a social security scheme; * giving free, informed, written consent signed by the participant and the investigator exclusion criteria: * be incapable of giving consent personally * be subject to a legal protection measure or be placed under judicial protection; * being pregnant or breastfeeding * present a serious and/or decompensated somatic or psychiatric illness

Keywords: focal seizure parkinson disease hyperkinetic seizures hypokinetic disorders dyskinesia networks basal ganglia
an evaluation of pono choices: a culturally responsive teen pregnancy and sti prevention program

Conditions: Teen Pregnancy; Sexually Transmitted Infections

Summary: the purpose of this study is to determine the impact pono choices has among youth for teen pregnancy and sti prevention measures such as: initiation of sexual activity; engagement in high risk sexual behaviors; knowledge of pregnancy and sti prevention; attitudes toward healthy sexual behaviors; skills in managing relationships and choices; and intentions about future sexual activity.

the study used a cluster randomized controlled design to evaluate the impact of pono choices. thirty-six middle schools in hawaii were randomly assigned to participate as either a treatment or control school. treatment school teachers were trained to deliver pono choices. control school teachers did not receive training and chose their own middle school sexual health education curricula. over 1,700 7th and 8th grade students in 34 hawaii schools enrolled into the study. as part of the study, students were invited to participate in baseline and follow-up surveys. the student survey responses were used to determine the impact pono choices has on teen pregnancy and sti prevention measures.

Eligibility criteria:
inclusion criteria: * cluster level: schools with grades 7 and 8 in hawaii * person level: students with parent consent and who read and understand english exclusion criteria: * cluster level: public middle schools which included grade 6 * person level: students who did not provide written assent

Keywords: adolescents teen pregnancy prevention sexually transmitted infections prevention place-based programs health education
comparison of self and clinician administered rating scales in patients with adhd

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Summary: the primary objective is to establish the concurrent validity of the clinician administered attention deficit hyperactivity disorder-rating scale (adhd-rs) and the patient administered attention deficit hyperactivity disorder self report scale (asrs) v1.1 symptom checklist.


Eligibility criteria:
inclusion criteria: * diagnosis of adhd * age 13-65\* \*parental consent and patient's assent will be obtained for minors participating in this protocol (only adolescents aged 13-18 yrs old will be included in the mgh site) exclusion criteria: * inability to reliably report adhd symptoms at the discretion of the investigator

Keywords: attention deficit hyperactivity disorder (adhd) adolescent
study of ins115644 ophthalmic solution in subjects with ocular hypertension or glaucoma

Conditions: Ocular Hypertension; Open Angle Glaucoma

Summary: the purpose of this trial is to evaluate the safety and tolerability of ins115644 ophthalmic solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of ins115644 ophthalmic solution.


Eligibility criteria:
inclusion criteria: * have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma * have best corrected visual acuity in both eyes of at least +0.5 or better * have normal endothelial cell counts and morphology exclusion criteria: * are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma * have a history of any type of intraocular surgery, except for cataract surgery * have had cataract surgery within three months

Keywords: bilateral ocular hypertension or early primary open angle glaucoma
otis cimzia pregnancy registry

Conditions: Crohn's Disease; Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis; Psoriasis

Summary: the purpose of the otis autoimmune diseases in pregnancy study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for five years after birth. with respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.

the purpose of the otis autoimmune diseases in pregnancy project, cimzia pregnancy exposure registry is to follow pregnant women with or without a cimzia approved indication who have or have not been treated with cimzia during pregnancy to evaluate the possible effect of these diseases, and or this medication on the pregnancy outcome including child development and growth up to five years of age.

Eligibility criteria:
inclusion criteria: * currently pregnant

Keywords: autoimmune disease certolizumab pegol cimzia pregnancy birth defect birth outcome tnf tumor necrosis factor
heart rate variability (hrv) in patients with neurogenic detrusor overactivity (ndo) before and after botulinum neurotoxin type a (bont/a) intradetrusor injections

Conditions: Bladder Disorder, Neurogenic

Summary: heart rate variability (hrv) is an important indicator of cardiac autonomic function and predictor of cardiac mortality and of all-cause mortality. in this study the investigators examined changes of the hrv in patients with neurogenic detrusor overactivity (ndo) undergoing botulinum neurotoxin type a intradetrusor injections (bont/a).

bont/a is a common treatment in patients with ndo. possible known side effects are urinary retention or increased post void residual. systemic side effects seems to be rare. however this has not been investigated in detail. although in very small amounts, bont/a can enter the systemic circulation during intradetrusor injections and might cause distant effects on other neuro-muscular systems, i.e. the heart. aim of this trial is to asses potential systemic adverse effects of bont/a on the heart following intradetrusor injections for ndo. potential effects on the cardiac autonomic function can be detected using hrv analysis. patients without relevant preexisting disorders of cardiac function and proven ndo are included. during four separate visits, all subjects receive two ecg measurements before (visit 1 and 2) and two ecg measurements following bont/a intradetrusor injections (visit 3 and 4). we investigate three different groups: 1) patients not receiving bont/a intradetrusor injections (= control group), 2) patients receiving intradetrusor injections with 100 units bont/a, and 3) patients receiving intradetrusor injections with 300 units bont/a.

Eligibility criteria:
inclusion criteria: * patient with neurogenic detrusor overactivity * written informed consent * medical indication for bont/a injections * able to learn or conduct clean intermittent self-catheterization exclusion criteria: * no written informed consent * pregnancy * cancer of infection of the lower urinary tract * cardiac pacemaker * previous heart attack, angina pectoris * medication with effect on hrv * previous cardiosurgery * cardiac arrhythmia * skin disease not allowing application of ecg-electrodes

Keywords: hrv ndo bont/a, adverse effects
the effect of art therapy on patients with stroke

Conditions: Ischemic Stroke and Hemorrhagic Stroke

Summary: stroke can affect the physical, emotional and social aspects of the patient and their family members. it is the main cause of complex disability, with a high number of people living with its effects. stroke can result in impairments in motor function, language, cognition, sensory processing, cognition, and emotional disturbances, which can affect the performance of functional activities and mental health status. getting patients involved in art therapy (at) class has shown to alleviate stress and promote a sense of wellbeing, which can aid their recovery and rehabilitation. the benefits of art therapy for people living with different health conditions worldwide have been reported, however, its effect on egyptian patients with stroke has been neglected.

art therapy refers to a group of techniques including painting, drawing and listening to music. the participants will receive the program on three steps (early step, middle step, and late step). these steps aim to train the participants on the at from simple to complex and motivate them to engage in the at program.therefore, this study aims to investigate the effect of art therapy on cognitive ability, arm activity and mental health status of patients with stroke.

Eligibility criteria:
inclusion criteria: * able to sit upright, supported or unsupported, * oriented to time and place by using the adapted arabic memory screening test, * able to perform at least two of the following skills: drinking from a cup, eating with a spoon and taking money from a purse by the affected arm, and * will stay in the stroke unit to at least 4 days (for receiving three sessions out of all sessions) before discharge, exclusion criteria: * diagnosis of transient ischemic attack or brain stem stroke; * unconscious; * unable to provide informed consent; * hemodynamical unstable medical conditions, including fever; * serious infectious diseases, for example, viral hepatitis or hiv; and/or * severe dementia or uncontrolled psychiatric problems.
gw273225 therapy added to current seizure treatments in patients with partial seizures

Conditions: Epilepsy

Summary: study to determine drug interactions between gw273225 and the anticonvulsants valproate, carbamazepine or phenytoin


Eligibility criteria:
inclusion criteria: * confident diagnosis of epilepsy * currently on vpa, cbz or pht * \>or= 4 seizures/4 weeks prior to screen exclusion criteria: * prior lamotrigine use (excluded if treatment discontinued for clinically significant safety reasons (i.e., rash, hypersensitivity)). * females of childbearing potential on hormonal contraceptives or hormone replacement therapy.

Keywords: epilepsy refractory seizure drug interactions pharmacokinetics
high altitude (ha) residents with pulmonary vascular diseseases (pvd), pulmonary artery pressure (pap) assessed at ha (2840m) vs sea level (la)

Conditions: Pulmonary Vascular Disease; Pulmonary Arterial Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Summary: to study the effect of relocation from 2840m (quito) to sea level (pedernales) in patients with pulmonary vascular diseases (pvd) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (ph) who permanently live \>2500m on pulmonary artery pressure (pap) and other hemodynamics.

this research in patients with pvd diagnosed with precapillary ph with right heart catheterization and classified to groups 1 and 4 (pah or cteph) who permanently live at ha \>2500 (pvd_ha) will have pap and other hemodynamics assessed by echocardiography and blood gases near their living altitude in quito at 2840m and at sea level in pedernales the day after the first and the second night after relocation.

Eligibility criteria:
inclusion criteria: * adult patients 18-90 years old of both genders, * residence \> 2500m of altitude * diagnosed with precapillary ph (mean pulmonary artery pressure (mpap) \>20 mmhg, pulmonary artery wedge pressure (pawp) ≤15 mmhg and pulmonary vascular resistance (pvr) ≥2 wood units (wu) by right heart catheterization) with ph being classified as pah or cteph according to guidelines * patients stable on therapy * new york heart association (nyha) functional class i-iii * provided written informed consent to participate in the study. exclusion criteria: * age \ 80 years * unstable condition * patients who cannot follow the study investigations, patient permanently living \< 2500m. * patients with moderate to severe concomitant lung disease (fev1\ 20 cigarettes/day) * severely hypoxemic patients at quito permanently have persistent oxygen saturation by pulse-oximetry (spo2) \<80% on ambient air. * patients with chronic mountain sickness (hemoglobin \> 19 g/dl in women, \>21 g/dl in men) * patient with a non-corrected ventricular septum defect * relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)

Keywords: pulmonary hypertension pulmonary vascular disease chronic thromboembolic pulmonary hypertension high altitude hypoxia pulmonary artery pressure arterial blood gases
establishing a ctdna biomarker to improve organ preserving strategies in patients with rectal cancer

Conditions: Rectal Adenocarcinoma; Stage II Rectal Cancer AJCC v8; Stage IIA Rectal Cancer AJCC v8; Stage IIB Rectal Cancer AJCC v8; Stage IIC Rectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8

Summary: this study measures the levels of circulating tumor dna (ctdna) in patients with stage ii-iii rectal cancer before, during, and after treatment to find out if the presence or absence of ctdna in patient's blood using the signatera test can be used to gauge how different treatments may affect rectal cancer. ctdna is dna from the rectal cancer that is circulating in the blood. the purpose of this study is to understand if the way rectal tumors respond to standard treatment can be associated with varying levels of ctdna.

primary objective: i. to estimate the percentage of participants that achieve complete clinical response. secondary objectives: i. to assess circulating tumor deoxyribonucleic acid (ctdna) status among participants receiving total neoadjuvant therapy (tnt). ii. to assess molecular residual disease (mrd i.e., ctdna status). iii. to assess the rate of transabdominal surgery. iv. to assess the rate pathological complete response after surgery. v. to assess the rate of watch and -wait (w\&w) after tnt. vi. to assess disease-free survival (dfs). vii. to assess overall survival (os). exploratory objectives: i. to characterize ctdna clearance or non-clearance patterns during tnt. ii. to correlate ctdna levels with a participant's pathological features. iii. to preliminary assess the prognostic performance of ctdna levels in relation to participant's clinical outcome. outline: patients undergo collection of blood samples at baseline (before any neoadjuvant therapy), every 2 months while undergoing tnt, and then every 3 months for up to 3 years after completion of tnt. patients' medical records are also reviewed. patients may undergo collection of tissue sample if an archival tissue sample is not available.

Eligibility criteria:
inclusion criteria: * participant must provide written informed consent before any study-specific procedures or interventions are performed * participants aged \>= 18 years * pathologically-confirmed stage ii or iii primary adenocarcinoma of the rectum: * t3n0m0 - t4bn2m0 exclusion criteria: * has radiologic evidence of distant metastases at the time of screening/enrollment * has received prior treatment for their rectal adenocarcinoma * requires or has received blood transfusion within 1 month of study enrollment