Kornimate/medical-research-clean huggingface dataset:
the contact-cti study: use of tissue contact data to guide atrial flutter ablation

Conditions: Atrial Flutter

Summary: this study will be a single blind prospective randomised control trial in patients undergoing ablation for the treatment of typical atrial flutter, with the aim of investigating the benefit of a new impedance-based computer software application which measures tissue contact between the ablation catheter and the inside of the heart. the investigators hope to demonstrate that the use of this tissue contact information reduces ablation time, xray time, and procedure time required to complete the procedure successfully. study participants will be randomly assigned to undergo their procedure with or without this contact data displayed for the doctor performing the ablation to see. the acute procedural endpoint of ablation is successful conduction block across the cavotricuspid isthmus of the right atrium. if the outcome of this study is positive, it will have a significant beneficial impact on this procedure, reducing procedure length, patient discomfort, and potentially reducing risk for the patient, recurrent arrythmia symptoms, and the need for repeat procedures later on.

patients in this study will be de novo cases of atrial flutter ablation, and they will be randomised to ablation using tissue contact data provided by the st. jude medical eci technology (active arm), or standard ablation as per physician practice, without the use of contact data to guide ablation (control arm). the endpoint measures will include rf ablation time, procedure time, time to achieving cavotricuspid isthmus block, the need for "touch up" ablation to achieve conduction block, the recurrence rate of isthmus conduction on isuprel infusion at 20 minutes post-isolation, and clinical recurrence of atrial flutter post-operatively.

Eligibility criteria:
inclusion criteria: 1. patient is undergoing de novo cavotricuspid isthmus ablation. 2. participant is willing and able to give informed consent for participation in the study. 3. male or female, aged 18 years or over exclusion criteria: (1) previous percutaneous or open surgical procedure involving the right atrium

Keywords: atrial flutter ablation irrigation contact eci
ligasure hemorrhoidectomy versus stapled hemorrhoidopexy

Conditions: Prolapsed Hemorrhoids

Summary: this study was designed to compare the outcome of ligasure hemorrhoidectomy and stapled hemorrhoidopexy for prolapsed hemorrhoids.

the study was designed as a single-blind, prospective, randomized controlled trial and was approved by the ethics committee of ahmadi hospital, kuwait. patients were randomly assigned to undergo either hemorrhoidectomy with the ligasure device or stapled hemorrhoidopexy. patients were blinded as to the type of procedure perform. candidates for the study were consecutive patients with symptomatic grade iii or iv hemorrhoids admitted to the ahmadi hospital (secondary care hospital), kuwait, from january 2006 through july 2007.

Eligibility criteria:
inclusion criteria: * adult (above 18 years) * with prolapsed hemorrhoids (grades iii or iv) exclusion criteria: * complicated hemorrhoid * coexisting perianal disease * previous perianal surgery * unfit for general anesthesia * pregnancy * history of bleeding tendency

Keywords: hemorrhoids prolapsed hemorrhoidectomy hemorrhoidopexy ligasure stapled
the safety and efficacy of lacrimal silicone intubation for the management of epiphora

Conditions: Epiphora

Summary: the purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.

epiphora is an overflow of tears,usually caused by insufficient drainage of the tear film from the eye.the most common cause is a blockage of the lacrimal ducts located next to the nose, but the condition may also result from the excessive production of tears. epiphora is a symptom rather than a disease and may be caused by a variety of conditions. 30 subjects will be recruited for this study, informed consent will be taken from the willing subjects. complete ophthalmic evaluation would be performed including visual acuity. diagnosis would be made on history of epiphora, regurgitation test, lids examination, nasal examination, probing and syringing. standard procedure of dacryocystorhinostomy (dcr) would be adopted in all cases with lacrimal intubation. syringing will be done on first follow up visit and skin sutures will also be removed. tightness and mobility of the silicone tube will be checked. the tube is kept in place for 3-6 months according to need and then finally removed. the patency of lacrimal passage will be investigated by irrigation. a successful outcome will be defined as resolution of symptoms like epiphora and discharge and a patent lacrimal system on irrigation.

Eligibility criteria:
inclusion criteria: * subjects having epiphora * canalicular blockade ascertained with probing * chronic dacryocystitis * mucocele exclusion criteria: * absent puncta * acute on chronic dacryocystitis * noticeable lid laxity * previous lacrimal surgery * patients younger than 15 years * suspicion of malignancy * post traumatic lids * bony deformity

Keywords: dacryocystorhinostomy
dexmedetomidine and propofol in children with history of obstructive sleep apnea

Conditions: Sleep Apnea, Obstructive

Summary: the purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (osa) having an mri scan. the results of this study will help in making the best decisions regarding the anesthesia medications that are most appropriate for children, adolescents, and young adults with osa during mri studies.

patients with osa are at risk for airway obstruction (a condition that makes it difficult to breath) during sedation and anesthesia. dexmedetomidine and propofol are safe and effective drugs regularly used by anesthesiologists. these drugs are used to put patients to sleep for operations and certain studies like mri scans. however, there have been no studies describing the effects these drugs have on the upper airway of children, adolescents, and young adults with osa.

Eligibility criteria:
inclusion criteria: 1. patients with documented history of osa by polysomnography who require anesthesia for mri sleep study or mri brain imaging study. 2. subjects must be 12 months to 25 years of age (inclusive) 3. either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study exclusion criteria: 1. the subject has life-threatening medical conditions (american society of anesthesiologists physical status 4, 5 or 6). the american society of anesthesiologists (asa) classification scale is a measure of physical status or how healthy the patient is. for our study, we will focus on children which are defined as asa i, ii or iii which means a healthy child (asa i), a child with a systemic disease that is mild and well controlled (asa ii) or a child with systemic disease that is severe and controlled (asa iii). 2. the subject is allergic to or has a contraindication to propofol or dexmedetomidine. 3. the subject has a tracheostomy or other mechanical airway device 4. the subject is not scheduled to receive anesthesia-sedation care for the mri 5. the subject has a history or a family (parent or sibling) history of malignant hyperthermia.

Keywords: obstructive sleep apnea mri pediatrics dexmedetomidine propofol anesthesia
comparing tai chi chih and relaxation therapy in the treatment of rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to compare the effectiveness of relaxation therapy and tai chi in treating the symptoms of rheumatoid arthritis (ra).

ra is a debilitating disease characterized by inflammation of the joints, leading to chronic pain, loss of function, and disability. complementary and alternative medicine (cam) treatments are being used with increased frequency by patients with chronic pain and rheumatic diseases to relieve their symptoms. while patients find these treatments helpful, there is limited scientific evidence of the effectiveness of these interventions. this study will compare relaxation therapy (a commonly used treatment for ra) to tai chi chih (a combination of slow, deliberate movements and meditation) in treating the symptoms of ra. participants will be randomly assigned to receive 12 weeks of either relaxation therapy or tai chi chih. at study entry and weeks 6 and 12, participants will complete questionnaires about their ra symptoms, health functioning, overall quality of life, and complete a brief medical exam.

Eligibility criteria:
inclusion criteria: * active adult onset rheumatoid arthritis * stable on disease-modifying antirheumatic drugs (dmards) or biologic medications * able to walk without use of an assistive device * resides in greater los angeles area * willing and able to comply with study requirements exclusion criteria: * uncontrolled or untreated medical conditions * frequent or uncontrolled disease flares * use of certain medications any medical condition deemed by the investigators to interfere with either the patient's safe participation or interpretation of the study data

Keywords: arthritis tai chi meditation relaxation techniques
an epidemiological study to evaluate the rsv-associated lower respiratory track in infections in infants

Conditions: Respiratory Infections; Bronchiolitis; Pneumonia; Apnea

Summary: the primary objective of this study is to describe the incidence of rsv-associated lri among infants \<1 year of age presenting to the ed during selected shoulder months.

* the primary objective of this study is to describe the incidence of rsv-associated lri or apnea (% rsv positive) among infants \<1 year of age presenting to the ed during selected shoulder months. the total number of events will also be described. * to characterize the clinical outcomes and demographic data of infants presenting to the ed with rsv-associated lri or apnea * to characterize the social burden (in the form of number of days lost from work by parent/ guardian) for these infants through 14 days after the index ed visit and through hospital discharge will also be described. * based on a sample of cases collected in a cohort of patients enrolled at or near the peak of rsv disease during the traditional season, a comparison of the rate of rsv between shoulder and peak periods will be described. * to describe the overall rates of rsv-associated lri or apnea based on the general ed statistics collected during the entire study period.

Eligibility criteria:
inclusion criteria: * written informed consent from parent/guardian to participate in this study * male and female infants \<1 year of age (child must be entered before his/her 1st birthday) * physician diagnosis of either a) acute lri or b) apnea below: a) acute lri, defined as: 1. medical diagnosis of bronchiolitis or pneumonia, or 2. in the absence of either of these diagnoses, lri will be determined by the investigator after review of the medical record and must include at least one of the following: * retractions * wheezing * rales or crackles * the presence of a new infiltrate, if a chest x-ray is available, which must be diagnosed by the ed physician or radiologist b) apnea, defined as either: 1. cessation of breathing for \>20 seconds by history or observation, or 2. cessation of breathing for any length of time if accompanied by cyanosis or pallor, bradycardia as detected by a monitor, or 3. ed primary diagnosis of apnea * parent/guardian has the ability and willingness to be available for a follow-up interview by telephone exclusion criteria: * use of palivizumab or rsv-igiv at any time prior to enrollment * participation in trials of investigational rsv prophylaxis or therapeutic agents

Keywords: acute lower respiratory infection retractions bronchiolitis or pneumonia wheezing rales crackles
gene therapy trial for otoferlin gene-mediated hearing loss

Conditions: Sensorineural Hearing Loss, Bilateral

Summary: part a of this trial will evaluate the safety and tolerability of a single unilateral administration of one of two dose levels of aavanc80-hotof and will evaluate the akouos delivery device to safely achieve the intended product performance.

the following two dose levels will be tested sequentially: * 4.1e11 total vg/cochlea * 8.1e11 total vg/cochlea

Eligibility criteria:
criteria for inclusion: 1. participants may be of any age, based on cohort criteria 2. at least two mutations in the otoferlin gene 3. clinical presentation of profound bilateral sensorineural hearing loss as assessed by abr 4. preserved distortion product otoacoustic emissions (dpoaes) 5. able and willing to comply with all study requirements, including willingness to participate in a separate long term follow-up study after completion of this trial criteria for exclusion: 1. persistent ear infections, anatomic or other abnormalities of the ear, and/or medical conditions that would contraindicate undergoing surgery, anesthesia, and/or administration of investigational gene therapy 2. bilateral cochlear implants 3. prior participation in a clinical trial with an investigational drug, within six months prior to administration, or any prior participation in a gene therapy clinical trial

Keywords: otoferlin auditory neuropathy (an) deafness, autosomal recessive 9 (dfnb9) hearing loss hearing loss, bilateral hearing loss, sensorineural
mmp-7 modulation by short and long term radiotherapy in rectal cancer patients

Conditions: Rectal Cancer

Summary: to analyse the effects of radiation therapy on inflammation and matrilysin levels in rectal cancer patients.


Eligibility criteria:
inclusion criteria: adenocarcinoma of the rectum, ability to understand written and oral information, written consent. exclusion criteria: colon cancer, benign tumors, impaired general condition of patient, declining to participate in the study, synchronous colonic tumors, logistical reasons, inability to understand written and/or oral information, previous pelvic irradiation, ongoing immunosuppressive therapy, diabetes with systemic complications.
a 2-year study of an investigational drug in obese patients (0557-011)

Conditions: Obesity

Summary: this is a 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.


Eligibility criteria:
inclusion criteria: * obese men and nonpregnant women at least 18 years of age with a specific body mass index (height and weight ratio) required by the study exclusion criteria: * patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)
a novel treatment for aphasia and apraxia of speech : measurement of outcomes

Conditions: Apraxia of Speech; Aphasia

Summary: in order to determine if speech-language therapy has positive effect, reliable measurement tools are required to document outcomes. currently, there is very limited information concerning the measurement of changes in speech production as a result of treatment for acquired apraxia of speech and aphasia. this study will obtain information concerning the reliability of several speech production measures over time. thirty persons with chronic aphasia and apraxia of speech will be asked to provide speech samples in response to commonly used assessment tools on three sampling occasions so that the stability of measurements may be examined. after establishment of appropriate outcome measures, a small, pilot treatment study will be conducted with four participants. the participants will receive a new treatment for aphasia and acquired apraxia of speech and outcomes will be measured relative to speech and language production.

a single group, repeated measures design will be used to obtain repeated speech samples from 30 persons with chronic acquired apraxia of speech and aphasia. speech samples will be elicited using commonly employed motor speech assessment protocols; an initial sample, a sample one week following the initial sample, and a sample at four weeks following the initial sample. the following measures will be obtained from the samples: percent consonants correct, percent fluent utterances, and duration of utterance. stability of the measures will be examined. after the preceding measures have been analyzed, a series of four, single-subject experimental designs will be conducted. four participants with chronic aphasia and apraxia of speech will receive a new treatment for aphasia and apraxia of speech applied sequentially to two sets of experimental picture picture stimuli. outcomes will be measured in terms of speech production (measures described above) as well as in terms of language production.

Eligibility criteria:
inclusion criteria: * veterans or non veterans with aphasia and apraxia of speech who reside in the salt lake city region (commutable), * 12 months or more post stroke or other focal brain injury, no other neurological conditions, * native english speakers, hearing adequate for experimental task (e.g., pass puretone screening at 35db at 500, 1k, 2k hz), * non linguistic cognition within normal limits exclusion criteria: * less than 12 months post stroke, * insufficient hearing, insufficient non linguistic cognitive skills, * neurological conditions other than stroke, * more than one stroke or brain injury * unable to attend treatment in the salt lake city vicinity

Keywords: aphasia apraxia of speech outcomes
investigating physiological adaptations to weight loss

Conditions: Obesity

Summary: the purpose of this study is to examine the effect of diet-induced weight loss on the levels of circulating nutrients and hormones which are involved in feelings of hunger and satiety.


Eligibility criteria:
inclusion criteria: * males and post-menopausal females * aged over 18 years * bmi 27-40kg/m2 * weight-stable exclusion criteria: * major comorbid medial condition (including diabetes) * taking medications known to affect weight * smoking

Keywords: weight loss weight maintenance
new therapeutic approach against bk virus infection based on monoclonal antibodies

Conditions: BK Virus Infection

Summary: bk virus (bkv) infection has a major negative impact on transplant recipients. no bkv-specific antiviral therapy is available, so there is an urgent need to develop new anti-bkv preventive and therapeutic strategies.


Eligibility criteria:
inclusion criteria: * bk positive * adult * ok to participed to research exclusion criteria: * under guardianship * under curatorship * opposed to research * deprived of liberty
to evaluate the efficacy and safety of luminomark injection in patients with nonpalpable breast lesions

Conditions: Breast Diseases

Summary: this study is a multicenter, open-label, parallel, phase 2 clinical trial in 6 weeks for screening, once investigational product injection, follow up visit.

the purpose of this study is to evaluate the efficacy and safety of luminomark inj. (conc. for fluorescence) localization in patients with nonpalpable breast lesions.

Eligibility criteria:
inclusion criteria: 1. female, 19 years ≤ age ≥ 80 years 2. those who be expected to do operation about non palpable breast lesion excision 3. those who have lesion vial mammography and breast ultrasound 4. written consent voluntarily to participate in this clinical trial exclusion criteria: 1. patients who be expected to do mastectomy 2. patients with multiple tumor or diffuse microcalcification 3. patients who have ink on invasive cancer or ductal carcinoma in situ despite 3 times local resection 4. patients who were treated with moderate to severe radiotherapy 5. patients who were treated with neoadjuvant chemotherapy 6. patients with active invading skin connective tissue disease 7. patients with local progressing breast cancer or inflammatory local progressing breast cancer 8. patients who have an allergy to investigational product or any of the component with the investigational product 9. patients who disagree about contraception for this clinical trial 10. a pregnant women or lactating women 11. patients who participated in other clinical trials within the past 12 weeks from the date of informed consent 12. patients who investigators determines unsuitable for this clinical trial

Keywords: nonpalpable breast lesions
evaluation of prefabricated cad/cam peek crowns used in primary molars: a randomised controlled clinical trial

Conditions: Dental Caries

Summary: fifty healthy cooperative children will be randomly allocated to two groups. group i (test group) will receive cad/cam peek crowns, while group ii (control group) will receive ssc. the crowns will be evaluated clinically and radiographically.

a two-arm randomized controlled clinical trial. a total of 50 healthy children aged 5-7 years, will be selected from pediatric dentistry and dental public health department, faculty of dentistry, alexandria university, egypt. children will be selected with scores 3 or 4 frankl behavioral rating scale. each child selected will have at least one mandibular second primary molar indicated for full coverage. written informed consent will be obtained from their guardians. participants will be randomly allocated into two groups according to the crown that will be used. group i (test group) will receive cad/cam peek crowns, while group ii (control group) will receive ssc. using modified ryge's criteria, the crowns will be examined clinically for anatomic form, restoration staining, marginal discoloration, colour match, surface roughness, marginal adaptation, proximal contact, occlusal wear of crown, wear of opposing tooth, and presence of cracks. gingival and plaques index scores will be recorded, as well as chairside time, patient and parental satisfaction. the patients will be recalled at 1 week then 3, 6 and 12 months for clinical follow-up. radiographs will be taken at 6 and 12 months.

Eligibility criteria:
inclusion criteria: 1. participant inclusion criteria * age ranges from 5 - 7 years. * children free of any systemic disease or special health care need (asa i).(30) * positive or definitely positive behaviour during preoperative assessments according to the frankl rating scale (score 3 or 4) (appendix i).(31) * patients whose parents will give their consent to participate. 2. tooth inclusion criteria * mandibular second primary molars that are indicated for full coverage:(7) * present opposing tooth. tooth exclusion criteria: * root resorption affecting more than one third of the root length. * clinical signs and symptoms of irreversible pulpitis or non-vitality. (appendix ii) (32) * fistula or abscess related to the selected tooth clinically and radiographically. * non restorable crowns. * signs of mobility or bone resorption.
analysis of gene expression in femoroacetabular impingement (fai)

Conditions: Femoroacetabular Impingement

Summary: femoral acetabular impingement (fai) is a common disease of the hip joint. in this study, whole-genome sequencing was used to further explore the pathogenesis of this disease.

femoral acetabular impingement (fai) is a group of chronic hip pain caused by the impact between the proximal femur and the edge of the acetabulum due to the anatomical abnormality of the hip joint, which damages the labrum and adjacent cartilage, and causes limited hip movement, especially limited flexion and internal rotation. however, the specific etiology of fai is still unknown at present. the application of genome-wide, exon and transcription research methods to the study of hip impaction syndrome can uncover key differentially expressed genes and provide a theoretical basis for the study of fai.

Eligibility criteria:
inclusion criteria: * the patient underwent preoperative imaging and was diagnosed with fai. the patient complained of pain in the hip, hip, or thigh, and had a positive hip flexion impact test. exclusion criteria: * patients with hip surgery history, hip osteoarthritis, necrosis of the femoral head, hip infection, hip dysplasia and other hip diseases.