Kornimate/medical-research-clean huggingface dataset:
treatment of bacterial vaginosis prior to active labor and infectious morbidity

Conditions: Bacterial Vaginoses

Summary: bacterial vaginosis (bv) is the most common cause of vaginal discharge among repro-ductive aged women. it is been linked to adverse maternal and neonatal outcomes. our objective is to evaluate if the use of a single dose of metronidazole in women with bv at time of delivery reduces infectious morbidities

the investigators are proposing a double-blinded, placebo controlled, randomized trial of 525 pregnant women undergoing induction or admitted in early labor and who are diagnosed with bacterial vaginosis. on admission to labor and delivery, patient will be counseled about the study. patients who agree to be enrolled, will sign informed consent. following enrollment patients will be screened for bacterial vaginosis by doing a speculum exam and testing for amsel's criteria. bv +ve patients will be randomized to receive either metronidazole 2 grams po once or identically appearing placebo. the pi, study coordinator, or a collaborator will be responsible for the informed consent. this will be a double-blinded randomized clinical trial. neither the patient nor provider will be aware of treatment assignment. as with any other in-stance in which antibiotics are administered, there is a chance of an allergic or other adverse reaction. the patient will receive standard inpatient monitoring during the labor course and in the postpartum period, and so any immediate adverse reaction would be promptly detected. patient will be assessed intrapartum for development of chorioamninoitis. postpartum patient will be assessed for infective complications up to 4 weeks. neonates will be assessed for morbidities by chart review for 90 days.

Eligibility criteria:
inclusion criteria: * women ≤50 years at the time of admission with the ability to give informed con-sent. * admission for induction of labor or early spontaneous labor with cervix ≤3 cm. * diagnosed with bacterial vaginosis at time of admission or in the week prior to admission if not treated * gestational age ≥ 34 weeks exclusion criteria: * spontaneous rupture of membranes * plan for elective cesarean delivery * allergy or contraindications to metronidazole * receipt of metronidazole or clindamycin in the admission for delivery for other in-dications. * hemodialysis * severe liver dysfunction * diagnosis of chorioamnionitis at the time of admission

Keywords: bacterial vaginoses in pregnancy
comparison of postoperative analgesia between intravenous paracetamol and intranasal tapentadol

Conditions: Lower Limb Fracture

Summary: the aim of the study was to compare the analgesic efficacy of intranasal tapentadol nasal spray 44.5mg and intravenous paracetamol 1gm during the postoperative period by visual analog scale(vas)in patients undergoing lower limb(long bone fractures)orthopedic surgeries. paracetamol is one of the most frequently used analgesic and antipyretic agents, interferes neither with platelet nor kidney functions nor does it present the unwanted side effects of nsaids. tapentadol is a novel, centrally-acting analgesic with a dual mechanism of action, combining mu-opioid receptor agonism with norepinephrine reuptake inhibition. this dual mode of action is responsible for its opioid-sparing effect, which contributes to a reduction in some of the typical opioid-related adverse effects

inclusion criteria age: from 18.00 year(s) to 60.00 years gender: both american society of anesthesiologists (asa) physical status: 1 \& 2, posted for elective lower limb orthopedic surgeries exclusion criteria 1. sepsis at the site of injection 2. coagulopathy 3. patients with history of renal, hepatic, cardiovascular disease 4. patient on chronic opioid use outcome comparing postoperative analgesia between the groups every 12 hours after the intervention till about 72 hours post intervention. the secondary outcome is to compare the need for the rescue analgesia between the groups

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) physical status 1 \& 2 2. posted for elective lower limb orthopaedic surgeries exclusion criteria: 1. sepsis at the site of injection 2. coagulopathy 3. patients with history of renal, hepatic, cardiovascular disease 4. patient on chronic opioid use
a study to evaluate the efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to determine if 12 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to placebo in subjects with ed solely secondary to a traumatic spinal cord injury

according to the massachusetts male aging study, erectile dysfunction (ed) is estimated as affecting approximately 30 million american men and 100 million men worldwide. the study also reported that approximately 52% of males aged 40-70 experience some degree of ed. prevalence has been shown to increase with age, with an estimated 40% of the responders experiencing ed at age 40, whereas, 67% had difficulties by age 75. considerable advances have been made since the nih consensus statement that defined ed as the persistent inability to achieve and maintain an erection sufficient for satisfactory sexual performance. however, one thing remains the same, sexuality continues to be a driving force in our society today. many men with erectile dysfunction suffer from issues of self esteem, self worth, the creation and maintenance of interpersonal relationships and in general, wrestle with an overall altered sense of wellbeing. damage to personal relationships can ensue; and the anger, depression, and anxiety engendered spill over into all aspects of life. viagra(sildenafil), administered as a flexible-dose regimen, has demonstrated to be an effective and well-tolerated treatment for ed in spinal cord injury sufferers.this is a multi-centre, prospective, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury.

Eligibility criteria:
inclusion criteria: 1. 18-65 years old, had ed more than 6 months 2. traumatic spinal cord injury was the sole cause of ed 3. patients had been in a heterosexual relationship for at least 1 month 4. documented written informed consent. exclusion criteria: 1. presence of symptomatic active urinary tract infection, indwelling urethral catheter. 2. patients who have used any kind of pde-5i prior to the study 3. other conditions that may cause ed such as history of radical prostatectomy, diabetes mellitus, anatomic penile abnormality and primary hypoactive sexual desire 4. history of symptomatic uncontrolled autonomic dysreflexia; postural hypotension 5. cardiovascular abnormality such as unstable angina pectoris, myocardial infarction or stroke, electrocardiographic ischemia or life-threatening arrhythmia, resting systolic blood pressure\>170 or \ 110mmhg 6. retinitis pigmentosa 7. patients who currently were using any of the following medications: nitrates, nitric oxide donors, androgen or antiandrogen, anticoagulants, trazodone, erythromycin, azole antifungals, other contraindicative medications in package insert 8. other contraindications in package insert

Keywords: erectile dysfunction spinal cord injury
comparing the efficacy of endoscopic fna vs fnb in diagnosing solid gastrointestinal lesions

Conditions: Pancreatic Tumor; Gastric Tumor; Esophageal Tumor; Lymphadenopathy; Duodenal Tumor

Summary: the purpose of this study is to determine if fine needle aspiration or fine needle biopsy is more efficacious and cost-effective than the other while maintaining diagnostic accuracy in the setting of solid gastrointestinal lesions.

when ultrasound is used during endoscopy, we are able to visualize the structures adjacent to the gastrointestinal tract in close detail. once the mass is visualized, we use endoscopic ultrasound to obtain a tissue sample, which the pathologist can examine in order to provide a diagnosis. the conventional method for obtaining a sample of tissue with endoscopic ultrasound is called fine needle aspiration (fna). this involves the insertion of a thin needle into the mass and obtaining a small sample of tissue which the pathologist can examine. an alternative technique is called fine needle biopsy (fnb), and involves the insertion of a thin double-edged needle into the mass. this double-edged needle may potentially provide a larger sample of tissue to examine. both of these techniques are commonly used, and both methods are equally safe. however, it is not known if one of these techniques is more effective at obtaining a sample of tissue or if one of these techniques is more cost-effective than the other. the purpose of this study is to determine if one method is more efficacious and cost-effective than the other while maintaining diagnostic accuracy. the results of this study may alter the way gastroenterologists obtain tissue samples during endoscopic ultrasound, improving the utility of the exam and reducing unnecessary healthcare costs.

Eligibility criteria:
inclusion criteria: * consecutive adult patients who require endoscopic ultrasound and tissue sampling of either a) pancreatic solid lesion, b) subepithelial solid lesion of the esophagus, stomach, duodenum or rectum, c) liver lesion, or d) lymph nodes or mass lesion located adjacent to the esophagus, stomach, duodenum or rectum * ability to give consent exclusion criteria: * inability to obtain informed consent * pregnant patients * patients under the age of 18 * severe cardiopulmonary disease preventing a safe eus procedure * patients unable to safely stop anti-coagulation therapy prior to eus procedure
pilot study evaluating the safety and efficacy of a patient-specific enteroatmospheric fistula isolation and management device independent of negative pressure wound therapy

Conditions: Fistula; Abdominal Injury; Negative Pressure Wound Therapy

Summary: this study aims to assess the efficacy of a custom fitted device designed to isolate enteroatmospheric fistulas effluent independent of negative pressure wound therapy and to evaluate the effects on the device related to dressing changes, time required for dressing changes, management costs, and the ease of use.


Eligibility criteria:
inclusion criteria: * stable condition, as determined by attending physician * has enteroatmospheric fistula (eaf) in the setting of open abdomen * eaf is determined to require surgical resolution exclusion criteria: * unstable condition, as determined by attending physician * significant risk of complication

Keywords: open abdominal wound care
extension study to ptr-01-002 (a study in recessive dystrophic epidermolysis bullosa (rdeb) patients previously treated with ptr-01)

Conditions: Recessive Dystrophic Epidermolysis Bullosa

Summary: a sub-set of patients who participated in ptr-01-002 will be enrolled in an open-label study, if they meet the study eligibility criteria.

protocol ptr-01-003 is a 4-part phase 2, open-label study of ptr-01 in patients who satisfactorily completed study ptr-01-002 and meet current enrollment criteria. in part 1, patients will be monitored monthly for up to 2 months with patient-reported and investigator assessments. in part 2, patients will receive a dose of 3.0 mg/kg every week for a total of 4 doses. this will be followed by part 3 in which patients will receive a dose of 3.0 mg/kg monthly for a total of 5 additional doses. at the end of each dosing period, efficacy assessments will be performed. during part 4, patients will be evaluated at months 1 and 3 after completion of dosing to assess the durability of wound healing and other efficacy parameters. safety will be assessed continuously throughout the study.

Eligibility criteria:
inclusion criteria: 1. willing to provide informed consent form, or if 12 to \<18 years of age, legal guardian has provided informed consent form and the minor has signed an assent form acknowledging that they understand and agree to study procedures. 2. has satisfactorily completed participation in ptr-01-002. 3. agrees to use contraception as follows: * for women of childbearing potential (wocbp) agrees to use highly effective contraceptive (including abstinence) methods from screening, through the study, and for at least 10 weeks after the last dose of study drug. non-childbearing potential is defined as a female who meets either of the following criteria: age ≥50 years and no menses for at least 1 year or documented hysterectomy, bilateral tubal ligation, or bilateral oophorectomy. * for males, agrees to use a condom with any wocbp sexual partner from day 1 of study treatment, through the study, and at least 10 weeks after the last dose of study drug. 4. be willing and able to comply with this protocol. exclusion criteria: 1. has known systemic hypersensitivity to any of the inactive ingredients in ptr-01. 2. has previously had an anaphylactic reaction to ptr-01. 3. is pregnant or nursing. 4. has received in the last six months any investigational gene therapy product or in the last three months any non-gene therapy investigational products (other than ptr-01). 5. is anticipated to receive new regimens of antibiotics or other anti-infectives during the trial. 6. has any other medical or personal condition that, in the opinion of the investigator, may potentially compromise the safety or compliance of the

Keywords: dystrophic epidermolysis bullosa epidermolysis bullosa rdeb eb
detecting absence seizures using hyperventilation and eye movement recordings

Conditions: Absence Epilepsy, Childhood; Absence Seizures; Absence Epilepsy; Epilepsy in Children; Staring; Seizures

Summary: this study is being done to find out if a smartphone app can identify absence seizures. children who have a history of absence seizures, as well as children without any seizure history, will be testing out the app. if participating the child will be guided through hyperventilation, an activity that asks the child to take quick, deep breaths. the app will record video of the child's face and sounds they make during hyperventilation. hyperventilation is a safe and established technique frequently used during eeg (electroencephalogram) to encourage seizure occurrence. the app will be used during a regularly scheduled eeg.

this observational study focuses on validating the use of the eysz mhealth app - a smartphone-based tool for guided hyperventilation (hv) and data collection - to aid clinicians in identifying absence seizures in people at risk for childhood absence epilepsy (cae). the eysz mhealth app will guide users through hv via interactive graphics while capturing audio and video data using smartphone sensors (e.g., camera, microphone) from which eye movements, facial biometrics/ expressions, number and length of exhales will be extracted. the goal of this observational study is to determine an epileptologist's performance in identifying hv-induced absence seizures using video data collected from a smartphone when compared to the gold standard interpretation of the eeg. the exploratory goal is to develop machine learning based algorithms to identify hv-induced seizures.

Eligibility criteria:
inclusion criteria: * typical absence seizure during use of the eysz hyperventilation recorder or control exclusion criteria: * other seizure type besides typical absence seizure during use of the eysz hyperventilation recorder * subclinical seizure activity * inability to participate with study procedures * contraindications to hyperventilation including history of subarachnoid hemorrhage, sickle cell anemia, recent cerebrovascular accident or myocardial infarction, significant cardiopulmonary disease, active asthma, known aneurysm, known moyamoya disease, or pregnancy. * people who have a history of generalized tonic clonic convulsions (gtcs) provoked by hyperventilation

Keywords: absence seizures absence epilepsy hyperventilation staring spells
a study to assess the safety of extended release alprazolam for the treatment of adolescents with panic disorder or anxiety with panic attacks

Conditions: Panic Disorder

Summary: the purpose of this study is to assess the long-term safety and tolerability of alprazolam extended release (xr) in adolescents with panic disorder, with or without agoraphobia, or in anxiety disorder with panic attacks. efficacy, population pharmacokinetics of alprazolam xr and the relationship between alprazolam xr plasma concentrations and efficacy outcomes will also be evaluated.

due to recruitment difficulties in this adolescent population, the clinical program for alprazolam xr was cancelled and this study was terminated on 1 september 2004. there were no safety concerns that led to this decision.

Eligibility criteria:
inclusion criteria: * subjects must meet one of the following 6 diagnoses: a. a current diagnosis of panic disorder with or without agoraphobia; b. generalized anxiety disorder with a history of at least one panic attack in the course of their illness; c. social anxiety disorder (social phobia) with a history of at least one panic attack in the course of their illness; d. separation anxiety with a history of at least one panic attack in the course of their illness; e. posttraumatic stress disorder with a history of at least one panic attack in the course of their illness; f. anxiety not otherwise specified with a history of at least one panic attack in the course of their illness. * educational level, intelligence, or other mental condition in the subject and/or his/her parent(s) are judged by the investigator to be sufficient to permit adequate informed consent/assent to be obtained, and for study procedures to be complied with. exclusion criteria: * current (in the past 6 months) diagnosis of obsessive compulsive disorder, major depressive disorder, dysthymic disorder, or alcohol and/or substance dependence. * current (in the past 3 months) diagnosis of alcohol and/or substance abuse. * primary diagnosis of conduct disorder, oppositional defiant disorder, or attention deficit hyperactivity disorder. * any current or past history of schizophrenia or psychosis; bipolar disorder or cyclothymia; dementia, delirium or other organic brain disease; an eating disorder; mental retardation, asperger's disorder, or any other serious developmental disorder. * a childhood depression rating scale, revised score \>35.
prognostic evaluation of severe sepsis and septic shock. procalcitonin versus delta sofa

Conditions: Severe Sepsis; Septic Shock

Summary: the purpose of this study is to compare the tendency of plasma concentration and clearance of procalcitonin in the first 24 and 48 hours of management of patients with severe sepsis and septic shock with another marker of early prognosis represented by 48 hours delta sofa.

this is a cohort prospective observational study that will include adult patients admitted to a multidisciplinary icu of a tertiary hospital.

Eligibility criteria:
inclusion criteria: * adult patients admitted to the icu * severe sepsis and septic shock exclusion criteria: * children * pregnant.

Keywords: prognosis sepsis septic shock procalcitonin sofa
biib023 long-term extension study in subjects with lupus nephritis

Conditions: Lupus Nephritis

Summary: the primary objective of the study is to evaluate the long-term safety and tolerability of biib023 in participants with lupus nephritis (ln).

this is an extension study for all participants who completed study 211le201 (nct01499355) through week 52 and did not discontinue biib023 or placebo. eligible participants from study 211le201 will be followed for up to 108 weeks. participants who received biib023 low dose or high dose in 211le201 will continue to receive the same dosing in this study (211le202; nct01930890) in addition to background therapy. participants who received placebo in 211le201 are randomized to receive either biib023 low dose or high dose in addition to background therapy.

Eligibility criteria:
key inclusion criteria: * subjects who completed week 52 of study 211le201 (nct01499355) and did not discontinue biib023 or placebo study treatment. * subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment. key exclusion criteria: * any significant change in medical history in subjects from study 211le201, including laboratory tests or current clinically significant condition that, in the opinion of the investigator, would have excluded the subjects' participation. the investigator must re-review the subject's medical fitness for participation and consider any diseases that would preclude treatment under this protocol. * subjects from study 211le201 who discontinued biib023 or placebo treatment prior to week 52 of study 211le201. * female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding. * unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol. * other unspecified reasons that, in the opinion of the investigator or biogen, makes the subject unsuitable for enrollment. note: other protocol-defined inclusion/exclusion criteria may apply.
comparing co2 laser and electrosurgical treatments for perianal condyloma

Conditions: Perianal Wart

Summary: perianal condyloma are skin- colored and fleshy lesions caused by various variants of human papilloma virus (hpv), most commonly 6 and 11. the treatment modalities available include topical options like podophyllin, imiquimod cream, trichloroacetic acid and cryotherapy, injectable options like interferon and 5-fluoroucil, and surgical options like excision, fulguration, cryotherapy, and laser removal. however, the treatment is usually short-lived, and the patients are subjected to multiple repeat procedures because of high recurrence and low clearance rates. surgical management has the highest clearance rate. there are several surgical modalities including excision, electrosurgical fulguration (esf), and laser vaporization. laser techniques work directly to destroy/transect the lesion, cause necrosis of infected keratinocytes and induce local inflammation. laser treatment is also reported to have minimal local surrounding tissue injury and sphincter injury, and less pain and discomfort. for this reason, laser therapy has been increasingly used to remove anogenital warts, and is a standard of care treatment of condyloma. we hypothesize that laser vaporization is effective to treat perianal condyloma and may have clinical benefits over esf. we will compare postoperative outcomes such as pain, healing, cosmesis and recurrence following either treatment method.


Eligibility criteria:
inclusion criteria: adults (\>18) treated in our crs department for perianal condyloma, not previously treated surgically, english speaking patients. exclusion criteria: \<18, intra-anal condyloma, previously treated for condyloma, other skin diseases in the perianal region, limited english proficiency. * adults unable to consent- exclude * individuals who are not yet adults (infants, children, teenagers)- exclude * pregnant women- exclude * prisoners- exclude
diclofenac potassium with lidocaine cream in reducing pain during hsg

Conditions: Pain Relief With HSG

Summary: the aim of our study is to determine the efficacy of oral diclofenac potassium combined with lidocaine cream on the pain scores during hsg.


Eligibility criteria:
inclusion criteria: * any patient came for hsg exclusion criteria: * any patient has contraindication to hsg