Kornimate/medical-research-clean huggingface dataset:
noninvasive evaluation of hepatic fibrosis in chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: chronic viral hepatitis c is a frequent liver disease. it is associated with variable degree of hepatic fibrosis. to date, liver histology is still regarded as the gold standard to detect, diagnose and quantify liver fibrosis. this requires to perform a liver biopsy. severe complications are associated to this procedure in 0.01 to 0.1% of cases. because of this, the repetition of the biopsy to evaluate the progression of the disease or the response to treatment poses ethical questions. also, liver biopsy only explore a minimal portion of the liver and liver fibrosis, which is not homogeneous, may be under- or over-estimated. to avoid risks linked to invasive technique and sampling errors associated to liver biopsy, efforts are being made to develop non-invasive technology to detect and quantitate liver fibrosis. in this study we will perform in patients with chronic hepatitis c, serum tests, fibroscan (elastography of liver parenchyma determined by ultra-sounds), and elastography of liver parenchyma by mri. this study will allow * to determine whether non-invasive tests effectively measure liver fibrosis * to compare each non-invase test with results of liver biopsy * to determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis c.


Eligibility criteria:
inclusion criteria: * alteration of liver function tests (alt, ast) * hcv rna positive exclusion criteria: * clotting disorder * ongoing treatment with anti-coagulant or anti-aggregant * advanced or decompensated cirrhosis (child-pugh class c) * hepatocellular carcinoma * other cancer * history of surgery for brain aneurysm * pace maker or defibrillator * ocular metal foreign body

Keywords: chronic viral hepatitis c hcv rna fibroscan fibrotest hepatic elastography by mri
regional or general anesthesia for carotid endarterectomy in patients with acute stage of ischemic stroke.

Conditions: Acute Ischemic Stroke

Summary: the study is planned to evaluate the effectiveness and safety of two types of anesthesia (regional and general) for carotid endarterectomy in 100 patients with acute stage of stroke: 50 patients will be operated under regional anesthesia and the remaining 50 patients under general anesthesia. patient inclusion criteria: 1. ischemic stroke in the middle cerebral artery territory 2. ipsilateral stenosis of the internal carotid artery more than 50% 3. neurological deficit at the time of surgical treatment: the modified rankin scale (mrs) score of 0-4 and the us national institutes of health (nihss) stroke scale score no more than 12 4. the size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply 5. terms of operation: from 1 to 28 days from the moment of ischemic stroke the primary intra-hospital and/or 30-day study endpoints: 1. perioperative ipsilateral ischemic stroke. 2. any stroke: contralateral ischemic or any hemorrhagic stroke. 3. myocardial infarction. 4. hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components. 5. surgical site infection 6. death 7. main adverse cardiovascular events (stroke + myocardial infarction + death).


Eligibility criteria:
inclusion criteria: * 1. ischemic stroke in the middle cerebral artery territory 2. ipsilateral stenosis of the internal carotid artery more than 50% 3. neurological deficit at the time of surgical treatment: the modified rankin scale (mrs) score of 0-4 and the us national institutes of health (nihss) stroke scale score no more than 12 4. the size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply 5. terms of operation: from 1 to 28 days from the moment of ischemic stroke exclusion criteria: -
protocol to obtain blood and bone marrow samples for myeloma research

Conditions: Multiple Myeloma

Summary: the purpose of this study is to collect a blood or bone marrow sample from patients with multiple myeloma and from volunteers without myeloma.

the blood and bone marrow samples will be used in the laboratory to perform focused studies on multiple myeloma.

Eligibility criteria:
inclusion criteria: * participant population is multiple myeloma patients over the age of 18 who are undergoing a scheduled bone marrow collection and/or blood drawing procedure as part of their routine treatment or follow up, and healthy volunteers over the age of 18 who have agreed to have a bone marrow and/or blood harvest as part of a donation to a transplant recipient. exclusion criteria: * patients, who in the opinion of their physician, would be adversely affected by removal of an extra15ml of blood and /or an extra 10ml of bone marrow.

Keywords: multiple myeloma
a study to assess the safety, tolerability and efficacy of op0201 as an adjunct treatment for acute otitis media in infants and children aged 6 to 24 months

Conditions: Acute Otitis Media

Summary: the purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal op0201 as an adjunct treatment to oral antibiotics for the treatment of acute otitis media (aom) in infants and children.


Eligibility criteria:
inclusion criteria includes but is not limited to: 1. male and female infants and children aged ≥6 months to ≤24 months 2. diagnosis of acute otitis media (aom) - moderate to severe bulging of the tm or mild bulging of tm and recent \[less than 48 hours\] onset of ear pain or intense erythema of the tm 3. score of 5 or more on the 5 question version of aom-sos scale1 4. written informed consent by the child's legal guardian and their willingness to ensure that study instructions are followed, all study-related visits are attended, that treatment administration is given, and parent/caregiver assessments are recorded according to the study protocol. 5. intact tympanic membrane (tm) in both ears (e.g., no perforation) exclusion criteria includes but is not limited to: 1. allergy to penicillin or cephalosporin 2. history or presence of immunodeficiency disorders 3. antimicrobial therapy within the 3 days (i.e., 72 hours) prior to day 1 4. craniofacial abnormalities (e.g., cleft palate or down's syndrome) that may interfere with eustachian tube function 5. disorders with decreased mucociliary clearance or higher viscosity of the mucous (e.g., cystic fibrosis, primary ciliary dyskinesia, kartagener's syndrome) 6. clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment
does virtual parental presence reduce preoperative anxiety in children

Conditions: Anxiety

Summary: children undergoing anesthesia are often very frightened by the experience. this can lead to bed wetting, nightmares and stranger anxiety that can last for weeks. moreover, this can influence their future experiences with anesthesia and surgery. the investigators believe the presence of a parent via video might work better as parental fear is not transferred to the child. the investigators also believe that parents who are coached on how to assist their child during anesthesia will have a better impact. as such the investigators are carrying out this study to assess whether parents who are coached and are present in either video or physical form will be more effective in reducing anxiety at induction of anesthesia.

the investigators' goal in this study is to investigate the effects of virtual parental presence and coaching of parents on anxiety in children at induction of anesthesia. the primary hypothesis is virtual parental presence during induction of anesthesia is superior to physical parental presence during induction of anesthesia in reducing anxiety in children at induction of anesthesia. the secondary hypothesis is that the coaching of parents modulates the effect of physical or video parental presence at induction anesthesia on children's anxiety.

Eligibility criteria:
inclusion criteria: 1. children from ages 18 months to 12 years old 2. american society of anesthesiologists physical status i, ii or iii 3. no previous exposure to anesthesia or surgery 4. same day surgery 5. english speaking parents and child exclusion criteria: 1. children with developmental delay 2. children with psychological / emotional disorders 3. children with language barrier 4. previous anesthetic or surgical experience 5. children whose eyes will be closed following surgery 6. children on sedative or psychoactive medication 7. history of allergy to medications in our study 8. children with expected difficult intubation 9. children presenting for emergency surgery 10. family history or personal history of malignant hyperthermia / risk of malignant hyperthermia 11. consent not obtained or withdrawal of consent 12. children who are violent during induction of anesthesia 13. cancellation of surgery
effectiveness of an educational program in the prevention of osteoporosis and fractures

Conditions: Fractures; Osteoporosis

Summary: the study will elucidate the effectiveness of an educational program in the prevention of osteoporosis and fractures. a random sample of the female population in southern finland (uusimaa region) within the age group of 60-70 years was drawn from the population registry. from 1996 through 2000, 2181 women from the population register were recruited and randomly assigned to the intervention and to the control group. the subjects in the intervention group have been on a multidisciplinary program and the subjects in the control group received osteoporosis prevention information through the media and health care system. an end point is any fracture during the ten-year follow-up.


Eligibility criteria:
inclusion criteria: * age 60-70 years and living in southern finland (uusimaa region)

Keywords: vitamin d bone density
preoperative warming prevents postoperative hypothermia in laparoscopic gynecologic surgery. a randomized control trial

Conditions: Hypothermia Following Anesthesia; Hypothermia; Hypothermia, Accidental; Body Temperature Changes; Hypothermia Due to Anesthetic

Summary: this study examined whether 20 minutes of prewarming prior to gynecological laparoscopic surgery prevented inadvertent post-operative hypothermia. treatment group received prewarming using a forced air body warming, control group received no active warming system. both groups were then warmed with forced air warmer intraoperatively.

inadvertent perioperative hypothermia is a well known perioperative complication. the behavioural response to hypothermia is the most powerful protective tool, more effective than any autonomic response, and is obviously removed in the operative setting. anesthesia alters thermoregulation by profoundly changing the thresholds for vasoconstriction and shivering, making patients vulnerable to the adverse outcomes related to mild hypothermia. inadvertent postoperative hypothermia can occur in up to 70% of surgical patients. it is defined as a core temperature below 36°c (96.8°f). the aim of this study was to determine if prewarming with an active warming system for 20 minutes preoperatively could prevent postoperative inadvertent hypothermia.

Eligibility criteria:
inclusion criteria: * asa i-iii * undergoing elective laparoscopic gynecological surgical procedures * expected duration \>60 minutes * bmi 18-45 exclusion criteria: * current fever (temperature\>38.1°c) * active endocrine disorders were exclusion criteria
hernia surgery urinary retention

Conditions: Hernia; Urinary Retention

Summary: investigating whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair.

the purpose of this study will be to investigate whether pre-operative treatment with a selective alpha1-adrenoceptor antagonist affects the likelihood of male patients developing post-operative urinary retention following hernia repair surgery. it is also of interest to determine whether or not a well-known urological screening tool, the ipss, can identify patients at risk for urinary retention following elective laparoscopic or open hernia repair surgery. we will investigate if it is possible to pre-treat patients with a selective alpha1-adrenoceptor antagonist which we think can reduce the incidence of post-operative urinary retention and the associated adverse consequences, especially in those patients at higher risk.

Eligibility criteria:
inclusion criteria: * male * 18 years of age * presenting with hernia requiring surgical intervention exclusion criteria: * intolerability of tamsulosin or related drugs * investigator discretion * unwillingness or inability to comply with protocol procedures and assessments
cera™ vascular plug system post-market clinical follow-up

Conditions: Aneurysm; Endoleak; Pulmonary Arteriovenous Malformation; Portal Hypertension; Arteriovenous Fistula; Splenic Laceration

Summary: the objective of the study is to collect and evaluate clinical data on patients of the lifetech cera™ vascular plug system to: * confirm the performance * confirm the safety * identify previously unknown side-effects * monitor the identified side-effects (related to the procedures or to the medical devices) * identify and analyse emergent risks

lifetech cera™ vascular plug system is indicated for arterial and venous embolization in the peripheral vasculature. this study, planned under the mdr requirements, aims to confirm the safety and performance of the lifetech cera™ vascular plug system, identify previously unknown side-effects, monitor the identified side-effects (related to the procedures or to the medical devices), identify and analyse emergent risks. the study intends to enroll 132 subjects. the estimated enrollment period is 1 year, and the expected duration of each subject's participation is 1 year (i.e., the follow-up period). final report shall be completed in 2026.

Eligibility criteria:
inclusion criteria: 1. aged 18 to 85; 2. life expectancy \> 1 year; 3. require arterial or venous embolization in the peripheral vasculature; 4. target embolization site(s) allow for safe insertion of the delivery catheter; 5. voluntarily sign and date the informed consent form (icf) prior to any study-related activities commencement; 6. willing and able to comply with protocol requirements, including all study visits and procedures. exclusion criteria: 1. the subject is pregnant or plan to be pregnant or breast feeding; 2. the subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride; 3. the subject has a known allergy or hypersensitivity to contrast agent; 4. the subject has uncorrectable coagulopathy; 5. the subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor xa inhibitors, vitamin k antagonists) or antiplatelet therapy before, during and/or after treatment with the study device, which, in the opinion of the investigator, would clinically interfere with the study endpoints 6. the subject has an unresolved systemic infection; 7. subject who cannot tolerate general or local anesthesia; 8. the subject has a connective tissue disorders (e.g. ehlers-danlos syndrome), arteritis (e.g. takayasu's disease) or another circulatory disorder; 9. the subject is participating in other drug or medical device clinical trials; 10. any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.

Keywords: lifetech cera vascular plug
a community-based intervention with popular opinion leaders (c-pol) in texas

Conditions: Risk Behavior; Sexually Transmitted Diseases

Summary: after exposure to the c-pol intervention: 1) unprotected vaginal or anal sex, sex with casual partners, concurrent sexual relationships, and exchange of sex for drugs or money will decrease significantly; 2) perceived syphilis-risk for self and peer group, knowledge about highly relevant risk-factors, information sources and resources will increase significantly; and 3) syphilis morbidity will decrease significantly in the intervention community as compared to the comparison community.

the c-pol in texas project is and intervention study which sought to impact the health behaviors of community residents who live in zip codes that have high syphilis morbidity. the study is being implemented in texas (dallas and houston) with residents of a housing developing and the surrounding community. the intervention model used for this study is the popular opinion leader (pol) model, which is effective at reducing new hiv infections. the intent of this study was to determine the effectiveness of a diffusion model (e.g. pol) at reducing syphilis infections in affected communities. for the intervention, community members identified as popular opinion leaders were recruited and trained to share accurate information about syphilis transmission, symptoms, testing, treatment and prevention. prior to intervention implementation and several times after, community members were given a survey and screened for syphilis as well as 2-3 additional stds. during each assessment, cross-sections of the community members were sampled.

Eligibility criteria:
inclusion criteria: * community members who live and/or frequent the affected community. the affected community was one that had significant syphilis morbidity at the onset of the study. exclusion criteria: * none

Keywords: risk behavior sexually transmitted diseases
the effect of combined robotic hand therapy and conventional therapy in stroke patients

Conditions: Stroke; Robot Assisted Therapy; Robotic Rehabilitation

Summary: rat is an innovative approach that includes intensive, repeatable, interactive and personalized applications.the aim of tihis study is to investigate the effect of robotic hand therapy added to conventional rehabilitation on rehabilitation outcomes in stroke patients.

effective therapy in stroke rehabilitation should include repetitive, functional and task-specific exercises with high intensity and duration. in this context, in addition to traditional treatments, many new treatment approaches have come up in recent years. robot-assisted therapy (rat) is one of these new treatment approaches. rat is an innovative approach that includes intensive, repeatable, interactive and personalized applications. it is seen that robotic systems are very suitable for the patient to receive more intense and task-oriented motor training by integrating with other rehabilitation approaches. considering the scarcity of studies on robotic hand therapy, it was seen that larger scale and long-term studies are needed. in this study, investigators aimed to investigate the effect of robotic hand therapy added to conventional rehabilitation on motor functions and quality of life in stroke patients. patients will be evaluated pretreatment, posttreatment and 3 months later after treatment. evaluation parameters consist of brunnstrom staging, modified ashworth scale (mas), fugl meyer assessment of the upper extremity, functional independence measure scale (fim) and abilhand questionnaire, stroke impact scale (sis), stroke-specific quality of life scale (ss-qol) and sf-36 quality of life questionnaire. we think that robot-assisted therapy will contribute to the improvement of hand functions and quality of life in stroke patients.

Eligibility criteria:
inclusion criteria: unilateral stroke between 4 weeks and 6 months after stroke health status was suitable for rehabilitation who could understand commands with a mini mental test score of 15 and above who had brunnstrom grade 3 and below (≤3). - exclusion criteria: patients with persistent upper extremity pain on the hemiplegic side (vas\>40) patients with severe spasticity in the hand (mas≥3) patients with contractures in the hand patients who had fractures or operations on the hemiplegic side in the last 6 months patients who received botulinum toxin injection to the upper extremity in the last 6 months patients with skin ulcers patients with brain stem or cerebellar lesions patients with neglect or apraxia patients with severe visual impairment and severe depression -
comparing study between concurrent chemoradiation and new combination treatment in cervical cancer patients

Conditions: Cervical Cancer

Summary: the purpose of this study is: * to compare the effectiveness between the new strategy of treatment (given cis-platinum plus gemcitabine-neoadjuvant chemotherapy followed by surgery),and standard treatment (given cis-platinum/carboplatin during radiation-concurrent chemoradiation)in specific group of cervical cancer patients (stage ib2-early iib) * to evaluate quality of life in both group of patients(standard treatment vs.experimental group)

according to figo classification of cervical cancer, stage ib2 was classified as clinically visible lesion more than 4.0 cm in greatest dimension and stage iib was classified tumor invades parametrium must not to pelvic wall. these were the common stages in thai cervical cancer patients,and made a troublesome effect to thai women. according to this study,stage early iib with 1/3 of parametrium involvement. mostly these two stage was treated with concurrent chemoradiation, challenging the possibility of late sequelae of radiation effect. this specific group of patients can be avoid the referred side effect by using neoadjuvant chemotherapy followed by radical hysterectomy with pelvic lymphadenectomy and para-aortic node sampling in operable cases (at least partial response- pr) and concurrent chemoradiation (ccr) in inoperable cases (less than pr). due to high risk type of these subspecific group, combination chemotherapy instead of single chemotherapy was used as ccr. however in operable cases with identified poor prognostic factor should be receive post operative radiation as the usual manner.

Eligibility criteria:
inclusion criteria: * cervical cancer patients with figo stage ib2-early iib * pathological proven squamous cell carcinoma or adenocarcinoma or adenosquamous cell carcinoma * ecog performance status 0-1 * no previous treatment for cervical cancer * acceptable hematological,renal,liver function exclusion criteria: * previous history of cancer * underlying disease not fit for surgery * psychological problem * obvious pelvic/para-aortic node involvement * pregnancy * hiv positive * history of bowel obstruction

Keywords: stage ib2-early iib of cervical cancer neoadjuvant chemotherapy cisplatin plus gemcitabine radical hysterectomy with pelvic lymphadenectomy quality of life stage ib2-iib of cervical cancer patients
prevalence of conjunctivitis and indentification of risk factors with and without prophylactic antibiotic treatment in neonates

Conditions: Ophthalmia Neonatorum

Summary: the french guidelines for the use of rifamycine eye drops in delivery room to prevent neonatal conjunctivitis have been actualized. only newborns exposed to risk factors of conjunctivitis should be treated, compared to previous guidelines, treating all newborns. currently, there are no data describing risk factors for neonatal conjunctivitis. this study evaluated the incidence of conjunctivitis with or without rifamycine eye drops treatment in the delivery room. then risk factors for neonatal conjunctivitis where analyzed.


Eligibility criteria:
inclusion criteria: * newborns at the university hospital of amiens\> 36sa, * admitted in maternity at the exit of nursery exclusion criteria: * newborns at the amiens university hospital \<36sa * eye drops for any medical reason within the first day of life.

Keywords: neonate, infant; eyewash; delivery room; prophylaxis; risk factor's