Kornimate/medical-research-clean huggingface dataset:
a study evaluating the safety, tolerability, and range of biologically active doses of icm-203 in mild to moderate knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to determine the safety, tolerability, and activity of icm-203, a recombinant adeno-associated viral (aav) vector that expresses a therapeutic gene that promotes cartilage formation, reduces joint inflammation and pain, as well as improves joint physical function, by injecting escalating doses of icm-203 or matching placebo into the knee of subjects with mild to moderate knee osteoarthritis (oa).


Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) of 18.0 to 40.0 kg/m2, inclusive, at the time of screening. 2. kellgren-lawrence grade 2 or grade 3 oa of target knee. 3. target knee pain between 4 and 9, inclusive, on an nrs ranging from 0 (no pain) to 10 (worst pain imaginable). 4. koos function in daily living score \>25, a measure of knee function ranging from 0 (extreme problems) to 100 (no problems). 5. a stable treatment regimen for symptomatic relief of oa, including nsaids, for 4 weeks prior to screening. exclusion criteria: 1. history of rheumatoid arthritis, psoriatic arthritis, gout, pseudogout, autoimmune oa, chondrocalcinosis, hemochromatosis, villonodular synovitis, and synovial chondromatosis or other disorder that in the opinion of the investigator could cause inflammation of the knee. 2. injection of steroid, hyaluronate or other agent, into the target knee less than 90 days prior to day 1. 3. major injury to the target knee, such as torn ligament or severe sprain, within 12 months of screening. 4. disability so severe that the subject cannot comply with the study requirements, including knee symptoms that result in significant difficulty or inability to walk. 5. surgery on the target knee within 180 days prior to day 1 6. total knee arthroplasty or other knee surgery planned in the next 12 months. 7. active joint infection or other concurrent medical (diabetes, uncontrolled hypertension, severe osteoporosis, glaucoma) or psychiatric condition that, in the opinion of the investigator, would make the subject unsuitable for the study.

Keywords: adeno-associated virus gene therapy icm-203 osteoarthritis
a placebo-controlled study of maralixibat (shp625) in pediatric subjects with progressive familial intrahepatic cholestasis (pfic)

Conditions: Progressive Familial Intrahepatic Cholestasis (PFIC)

Summary: the purpose of this study is to determine if the investigational treatment (maralixibat) is safe and effective in pediatric participants with progressive familial intrahepatic cholestasis (pfic).


Eligibility criteria:
key inclusion criteria: * informed consent and assent (as applicable for participants less than or equal to (\<=) 18 years per institutional review board/ethics committee (irb)/ethics committee (ec) as appropriate. * male or female participants between the ages of 12 months and 18 years inclusive (primary cohort) or birth to 18 years inclusive (exploratory cohort) at time of consent, with a body weight greater than or equal to (\>=) 5 kilogram (kg). * cholestasis as manifested by total sba greater than (\>) 3\*upper limit of normal (uln) * an average am itchro(obs) score \>= 1.5 during the 4 weeks leading to the baseline visit * diagnosis of pfic based on: a. primary cohort: i. participants with 2 documented mutant alleles in abcb11 (pfic2); participants without bile salt export pump (bsep) function (biallelic truncating mutations in abcb11) will not be enrolled into the primary cohort. b. exploratory cohort: i. participants with pfic1/3/4 or pfic2 with biallelic truncating mutationsiii.infants from birth to \<12 months of age with pfic ii. participants with pfic after internal or external (eg, pebd) biliary diversion surgery with unsatisfactory pruritus control or where biliary diversion was reversed. key exclusion criteria: * chronic diarrhea requiring intravenous fluid or nutritional intervention for the diarrhea and/or its sequelae. * history of surgical disruption of the enterohepatic circulation (applies to primary cohort only). * liver transplant * decompensated cirrhosis (international normalized ratio \[inr\] \>1.5, albumin \<30 gram per liter \[g/l\], history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy). * alt \>15\*uln at screening. * history or presence of other liver disease. * history or presence of any other disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs, including bile salt metabolism in the intestine (example \[eg\], inflammatory bowel disease), per investigator discretion. * liver mass on imaging * known diagnosis of human immunodeficiency virus (hiv) infection. * any prior cancer diagnosis except for in situ carcinoma or cancers treated within 5 years of the screening visit (visit 0) with no evidence of recurrence.

Keywords: cholestasis maralixibat mutation
ice versus emla for pain in laser hair removal

Conditions: Hair Removal

Summary: the primary objective of this study is to compare the efficacy of ice pack to topical eutectic mixture of local anesthesia (emla) for pain control in diode 810 nm laser axillary hair removal. this study is a pilot study designed to determine feasibility of these procedures.


Eligibility criteria:
inclusion criteria 1. subjects are caucasian or asian females. 2. subjects are 18-65 years old. 3. subjects have fitzpatrick skin type i-iii and coarse dark axillary hair. 4. subjects are in good health. 5. subjects can provide informed consent. 6. subjects have the willingness and the ability to understand and communicate with the investigators. exclusion criteria 1. subjects who are allergic to lidocaine or prilocaine. 2. history of methemoglobinemia. 3. history of recurrent petechial or purpuric lesions. 4. bleeding tendency or coagulopathy. 5. history of laser treatment in axilla. 6. history of keloid or hypertrophic scarring. 7. pregnant or lactating or intends to become pregnant in the next 3 months. 8. active skin disease or skin infection in the treatment area. 9. subjects with known mental illness or other psychological conditions, such as psychotic disorders, mood disorders, anxiety disorders and cognitive disorders. 10. history of cold urticaria. 11. history of current injury or abnormal skin sensation. 12. unable to understand the protocol or to give informed consent. 13. any other condition that would, in the professional opinion of the investigator, potentially affect response or participation in the clinical clinical study, or would pose as an unacceptable risk to subject.
nebulized epinephrine vs. salbutamol in bronchiolitis among children

Conditions: Respiratory Distress Score

Summary: acute bronchiolitis, mostly secondary to infection due to respiratory syncytial virus (rsv) is very common in infants under two years old. it is usually benign. however, the dyspnea it causes is a big concern for parents and this disease can take a severe form on certain particular ground thus constituting a frequent reason for hospitalization in pediatrics. nebulized epinephrine showed more efficacy than nebulized salbutamol.

the objective of this study is to determine if nebulized epinephrine is more efficacious than nebulized salbutamol in all hospitalized children (1 month to 24 months) in treatment of bronchiolitis. a randomized clinical trial which recruits children admitted to the pediatrics department with diagnosis of bronchiolitis. children aged 1 month to 2 years will be included in the study. children who meet the inclusion criteria will be alternately distributed in two groups: group 1: will receive salbutamol (2 units/kg) with 3 ml normal saline by nebulizer. group 2: will receive epinephrine (0.5 mg/dose) with 3 ml normal saline by nebulizer. all admitted patients will receive aerosol every 20 minutes three times and after, depending on the clinical status of the patients, they will be given oxygen therapy at 1.5 liters / minute at the admission if oxygen saturation is below 94% till the normalization of the oxygen saturation. clinical parameters such as clinical score, oxygen saturation with pulse oximetry, heart rate, and temperature will be measured at admission, at hour 1 to hour 12 and then every 24 hours until they are discharged.

Eligibility criteria:
inclusion criteria: * children diagnosed with acute bronchiolitis. exclusion criteria: * children with congenital heart disease or * chronic lung diseases
post market clinical follow-up study in patients treated with the on-x ascending aortic prosthesis (aap)

Conditions: Aortic Valve Disease

Summary: the ascend post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the on-x ascending aortic prosthesis (aap) used in surgical aortic valve replacement.

in this study patients will be observed that receive an on-x aap implant for the treatment of a diseased, damaged, or malfunctioning native or prosthetic heart valve. the on-x aap will be implanted at the discretion of the treating physician. participating physicians will be asked to provide their observations collected during routine care for patients he/she had decided to treat with the on-x aap. written informed consent, specifically allowing the use of clinical records for this observational study, will be obtained from every patient in europe and every patient that is alive in the us prior to data collection where required. in europe, every patient will be enrolled prospectively prior to the intervention. in the us, patients can be enrolled retrospectively after the intervention or prospectively prior to the intervention. the data from patients who have died following their implant will be recorded in the database without the requirement for written informed consent after irb approval. the period of data collection will be approximately 60 + 6 months (depending on the date of the last follow-up visit) from the surgery for each patient. echocardiography images at prior to discharge, at 12 months, 60 months will be evaluated by a corelab. all adverse events defined in the clinical event committee (cec) charter will be adjudicated by the cec.

Eligibility criteria:
inclusion criteria: * patient ≥ 18 years of age at time of on-x aap implant * patient understands and has signed the informed consent form: * prior to implant of on-x aap or * post implant (us only) or * patient died prior to enrollment (us only) * patient is willing and able to participate in follow-up exclusion criteria: * patient unable to tolerate anticoagulation therapy * patient with active endocarditis at the time of his / her on-x aap implant * patient participates / participated in another clinical investigation which may interfere / may have interfered with the effectiveness of anticoagulation therapy * patient has anomalous anatomy or medical, surgical, psychological or social history or conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements of the clinical investigation results * patients in which on-x aap is implanted in combination with amds or fet * patient's life expectancy is less than 3 years in the opinion of the investigator

Keywords: aortic valve stenosis thoracic aneurysm dissection valved conduit
study of the anatomical direct insertion anterior cruciate ligament reconstruction

Conditions: Rupture of Anterior Cruciate Ligament

Summary: the purpose of the study is to study the effect of anatomical direct insertion acl reconstruction compared with conventional anatomical acl reconstruction.

the investigators divide 320 patients with acl rupture into 4 groups, each group has 80 patients. the operation technique is different among the groups: group a: conventional anatomical double bundle acl reconstruction, group b: conventional anatomical single bundle acl reconstruction, group da: direct insertion double bundle acl reconstruction, group dsb: direct insertion single bundle acl reconstruction. the investigators compare the results of the patients of each group at 2 years of surgery.

Eligibility criteria:
inclusion criteria: * acl rupture patients aged between 16 to 40 years exclusion criteria: * combined severe injuries to the operated knee (additional ligament rupture, major meniscus loss, patella instability, cartilage damage \>2°, pathologic leg axis deviation) * any injury or surgery to the contralateral knee * any infammatory or systemic disease, neuromuscular disease in the lower limbs, any recent knee infection

Keywords: anterior cruciate ligament reconstruction direct insertion of anterior cruciate ligament
brown adipose tissue activity and age

Conditions: Obesity; Ageing

Summary: in this study the investigators aim to investigate whether the sympathetic stimulation of bat, as assessed with a 123i-metaiodobenzylguanidine single-photon emission computed tomography computed tomography scan, differs between young and elderly subjects, as an explanation for the diminished metabolic brown adipose tissue activity in the elderly. the investigators hypothesis is that sympathetic nervous system activity in the elderly is diminished as compared to their younger counterparts as an explanation for the diminished metabolic brown adipose tissue activity in the elderly.

the sympathetic nervous system is the primary activator of brown adipose tissue. elderly are known to have less metabolically active brown adipose tissue as compared to their younger counterparts. the reason for this diminished metabolic brown adipose tissue activity is unknown. however, a lower sympathetic nervous system activation to brown adipose tissue in the elderly might explain a diminished metabolic brown adipose tissue. therefore, in this study, both the sympathetic nervous system activation to brown adipose tissue and the metabolic activity will be measured in young and older subjects. sympathetic nervous system activity will be measured using 123i-metaiodobenzylguanidine single-photon emission computed tomography computed tomography scans, metabolic activity will be measured using 18f- fluorodeoxyglucose positron emission tomography ct scans.

Eligibility criteria:
inclusion criteria: * male * caucasian origin * subjects should be able and willing to give informed consent * 18-65 years old * bmi range of 19-27 kg/m2 exclusion criteria: * renal failure (creatinine\>135mmol/l) * daily use of prescription medication * prior participation in a research protocol involving radiation exposure in the last 2 years

Keywords: brown adipose tissue ageing sympathetic nervous stimulation obesity
ofc rtms in emotionally unstable and depressed patients

Conditions: Personality Disorder, Borderline; Personality Disorder; Unstable; Depression

Summary: treatment of depression with conventional transcranial magnetic stimulation (rtms) has shown high evidence using high-frequency left dorsolateral prefrontal cortex (dlpfc) stimulation. recently, it could be demonstrated that treatment of the right orbitofrontal cortex may be effective in patients who did not respond to conventional dlpfc rtms. orbitofrontal cortex (ofc) seem to be involved in the etiopathology of emotionally instable personality disorders. thus, the present one-arm trial is a pilot study investigating if ofc rtms is feasable, tolerable and effective.


Eligibility criteria:
inclusion criteria: * icd-10: f60.30 or f60.31 * depressive symptoms and hamd-21 score of at least 7 * sex: female and male * residence in germany and german speaking * written informed consent exclusion criteria: * meeting the contraindications for transcranial magnetic stimulation (electric devices or metal implants in the body, e.g. cardiac pace maker, insulin pump) * neurological disorders (e.g. cerebrovascular events, neurodegenerative disorder, epilepsy, brain malformation, severe head trauma) * participation in another study parallel to the trial * other mental or somatic illness which is not compatible with participation according to the principal investigator * pregnancy or breastfeeding period * psychiatric confinement

Keywords: rtms
self-guided online cognitive behavioral strategies for chemotherapy-induced peripheral neuropathy

Conditions: Peripheral Nervous System Diseases; Pain Management; Self Management

Summary: the purpose of this pilot randomized wait-list controlled trial is to test the efficacy of an online cognitive behavioral pain management website called proactive self-management program for effects of cancer treatment (propsect) to reduce worst pain intensity for individuals with chronic painful chemotherapy-induced peripheral neuropathy (cipn) and to explore the mediating effect of prospect-induced changes in anxiety, fatigue, depression, and sleep disturbance on worst pain intensity. another aim of this study is to determine whether prospect will decrease cipn symptom severity (e.g. non-painful numbness and tingling), average pain severity, and physical impairment. lastly, since this intervention has never been tested in individuals with painful cipn, the investigators will assess patients' perceptions of acceptability and satisfaction with the intervention.


Eligibility criteria:
inclusion criteria: 1. over 25 years of age 2. self-report 4/10 worst cipn pain that has persisted three months or longer after the cessation of their neurotoxic chemotherapy regimen 3. have at least grade one sensory cipn as defined by their oncology provider using the national cancer institute common terminology criteria for adverse events (nci-ctcae) 4. have a stable analgesic medication regimen as evidenced by a less than 10% increase or decrease in their analgesic medication dosage in the two weeks leading up to their enrollment in the study 5. have internet access 6. self-report the ability to use a computer 7. signed informed consent 8. willingness to participate in all study activities. exclusion criteria: 1. prognosis of less than three months 2. documented peripheral neuropathy due to other causes (diabetes, alcohol abuse, central nervous system malignancy, vitamin b deficiency, hereditary, nerve compression injury) 3. neurotoxic chemotherapy treatment regimens are planned to occur while enrolled in the study 4. have participated in cognitive behavioral pain management in the past or plan to enroll in cognitive behavioral pain management during the course of the intervention.
the effect of breathing exercises in addition to conventional treatment in frozen shoulder patients

Conditions: Frozen Shoulder; Pain; Quality of Life

Summary: the study aimed to investigate the effect of breathing exercises in addition to conventional treatment on pain, normal joint movement and quality of life in patients with frozen shoulder. a simple random number table will randomly divide participants into two groups. the study group (20 participants) will be given 15 sessions of respiratory exercises in addition to the 15 sessions of physiotherapy provided routinely for treatment. the control group (20 participants) will receive 15 sessions of physiotherapy services in addition to the routine 15 sessions of the physiotherapy department.

after completing the demographic information form, a visual analog scale will be used for pain intensity, a baseline digital goniometer will be used to measure the normal joint range of the shoulder girdle, and a short form sf-36 will be used for quality of life. all participants will be evaluated before and after 15 sessions. the same assessments will be performed in both groups. the evaluations are expected to last 40 minutes in total. the study group (20 participants) will be given 15 sessions of respiratory exercises in addition to the 15 sessions of physiotherapy provided routinely for treatment. the control group (20 participants) will receive 15 sessions of physiotherapy services in addition to the routine 15 sessions of the physiotherapy department.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * having a diagnosis of a frozen shoulder, * volunteering to participate in the study * not having any problem that may prevent respiratory exercise. exclusion criteria: * not volunteering to participate in the study, * having undergone upper extremity surgery, * history of previous shoulder surgery, shoulder subluxation or dislocation, * any mental or sensory problems, * acute infection or chronic disease of neurological, psychiatric, orthopedic, cardiological, rheumatological, etc. origin, * having any respiratory disease
insulin on post burn hypermetabolism

Conditions: Burns

Summary: the purpose of this study is to examine the effects of insulin on helping burn patients recover faster from their burns.

severe injuries produce profound hypermetabolic stress responses which cause severe loss of lean body mass and muscle wasting, immunologic compromise, slowed wound healing, and related bone loss, all which contribute to increased morbidity, mortality, and prolonged recovery from injury. the results of hypermetabolism persist for weeks to months depending on the severity of the insult. massive burns can cause severe catabolism and are an excellent model to study the general effects of injury on protein metabolism. severe burns are characterized by dramatic increases in energy utilization and alterations in the metabolism of carbohydrates, fat, and protein. insulin treatment improves net protein synthesis in the severely burned, principally through improved muscle protein synthesis. although controversy exist as to whether insulin is effective as an anabolic hormone through increasing protein synthesis or decreasing protein breakdown, we believe that consideration of the methods and experimental protocols used in the various studies bear consideration when evaluating this topic.

Eligibility criteria:
inclusion criteria: * burn equal to or greater than 20% total body surface area (tbsa) * between the ages of 18-72 years * burns occurred within 14 days of coming to burn center exclusion criteria: * heart attack within 3 months * have or have had cancer * seizure disorder * pregnancy * pre-existing arterial insufficiency * diabetes or known history of hypoglycemia * allergy to iodine or shellfish

Keywords: severe burns hyperinsulinemia insulin muscle protein kinetics immune function exercise
surgical correction of astigmatism

Conditions: Astigmatism

Summary: laser correction for myopia and astigmatism using an excimer laser has been performed with success for several years. during the last 2 years, a new method for correction of refractive errors has emerged. in the method (relex) a femtosecond laser is used to cut a lenticule in the corneal stroma that is subsequently removed. for simple myopia this method has proved effective and on par with excimer baser lasik. however, it remains to be determined if relex is as effective in the treatment of astigmatism. in the study, patients with high astigmatism are treated with conventional lasik for astigmatism in one eye and with relex for astigmatism in the other.


Eligibility criteria:
inclusion criteria: * myopic astigmatism between -2.0 and -5.0 diopters * maximal difference in spherical equivalent refraction of 2 d between eyes * no ocular or systemic disease * not pregnant or breastfeeding * minimum bscva of 0.8 (decimal) * normal corneal topography * sufficient corneal thickness to allow the treatment exclusion criteria: * subjects not fulfilling the above criteria