Kornimate/medical-research-clean huggingface dataset:
azd9668 relative bioavailability

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this clinical study will aid future formulation development and optimisation of azd9668 tablets by evaluating possible effects of minor changes to the formulation and process on the rate and extent of absorption.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study-specific procedures * female subjects may be of non-child bearing potential (i.e. post menopausal or surgically sterile) or of child bearing potential * body mass index (bmi) ≥18.0 and ≤30.0 kg/m2 calculated from height and weight at the screening visit; minimum weight 50 kg. * clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol, cotinine and negative test results for hepatitis b surface antigen, antibodies to hepatitis c virus and antibodies to hiv-1/2 at the screening visit * be a none smoker or ex-smoker who has stopped smoking for \>6 months prior to visit 2 (pre-entry) exclusion criteria: * any clinically significant disease or disorder (eg infections/viral disease, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment), which in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the absorption, distribution, metabolism and excretion of drugs. * any clinically relevant abnormal findings in physical examination, vital signs, clinical chemistry, haematology, urinalysis, which, in the opinion of the investigator, may put the subject at risk because of his/her participation in the study * any ecg abnormality (including cardiac arrhythmia) which in the opinion of the investigator may put the subject at risk

Keywords: copd
learning curve of external pop out as a new technique for lower uterine segment support

Conditions: Cesarean Section Complications

Summary: cesarean section represent the most significant operative intervention in all of obstetrics, its development and application have saved lives of countless mothers and infants. the frequency with which its carried out continues to rise and has in many hospitals and health regions reached rates in excess of 30%(


Eligibility criteria:
inclusion criteria: 1. singleton term pregnancy 2. cephalic presentation 3. women who will accept to participate in the study exclusion criteria: 1. non-cephalic presentation 2. congenital fetal anomalies 3. multiple pregnancy 4. preterm caesarean \< 37 weeks 5. cases with marked adhesions obscuring the lower uterine segment thickness
a multi-center, double-masked evaluation of the efficacy and safety of csf-1 in the treatment of presbyopia

Conditions: Presbyopia

Summary: this is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of csf-1 in the treatment of presbyopia.

this is a 4-visit, multi-center, randomized, double-masked, parallel group study evaluating the safety and efficacy of csf-1 in the treatment of presbyopia. approximately 150 subjects will be enrolled across 7 study centers in the united states. at visit 2, subjects will be randomized 1:1:1 to one of three treatment arms: csf-1, csf-1 component #1, or csf-1 component #2. all subjects will dose twice a day in both eyes with a single drop of their assigned treatment for approximately 1 week. at visit 3, subjects randomized to csf-1 will now receive a different concentration of csf-1, subjects randomized to csf-1 component #1 will receive a different concentration of csf-1 component #1 and subjects randomized to csf-1 component #2 will continue dosing with the same concentration of csf-1 component #2. all subjects will continue dosing twice a day in both eyes for approximately 1 week.

Eligibility criteria:
inclusion criteria: * subjects must: 1. have presbyopia exclusion criteria: * subjects must not: 1. have any contraindications to the study medications or diagnoses that would confound the study data
feasibility study of metformin therapy in adpkd

Conditions: Polycystic Kidney, Autosomal Dominant

Summary: this study is being done to determine if treatment with metformin, a drug widely used for the treatment of diabetes type 2, is safe and well tolerated by individuals with autosomal dominant polycystic kidney disease (adpkd) who are not diabetic and who have slightly decreased kidney function. the study will also evaluate the effects of metformin on kidney growth and kidney function.

patients with adpkd are still in need for a well-tolerated treatment that can be used long-term to prevent cyst growth and kidney function decline. metformin has a long track record of a low risk-to-benefit profile in patients with diabetes or at risk for diabetes. metformin inhibits two key processes responsible for the growth of polycystic kidneys, i.e. fluid secretion and cell proliferation, as shown in cell cultures and animal models of adpkd. experiments in animal models of chronic kidney disease demonstrate that metformin administration prevents kidney fibrosis and preserves kidney function. diabetic patients who are treated with metformin appear to develop less kidney failure and live longer than patients who are treated with other anti-diabetic medications. therefore this drug is promising for people with adpkd, with the potential to slow cyst enlargement and preserve kidney function.

Eligibility criteria:
inclusion criteria: * autosomal dominant polycystic kidney disease and * an estimated glomerular filtration (gfr) rate of 50-80 ml/min/1.73 m2; * subject is able to sign an informed consent exclusion criteria: * diabetes mellitus, * active infection, * congestive heart failure, * liver disease, * alcohol or substance dependence, * cigarette smoking within the last 12 months; * females who are pregnant or breast feeding, or * are unwilling to use contraception; * are unable to undergo magnetic resonance imaging, or * have a contraindication to the use of metformin

Keywords: metformin total kidney volume glomerular filtration rate
dose-response study of efficacy and safety of botulinum toxin type a to treat spasticity of the leg(s) in cerebral palsy

Conditions: Lower Limb Spasticity Due to Cerebral Palsy

Summary: the purpose of this study is to determine whether injections of botulinum toxin type a into muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.


Eligibility criteria:
inclusion criteria: * female or male subject of 2 to 17 years of age (inclusive). * uni- or bilateral cerebral palsy with clinical need for uni- or bilateral ll injections with bont for the treatment of spasticity. * ashworth scale \[as\] score ≥2 in plantar flexors (at least unilaterally). * clinical need for a total dose of 16 u/kg bw nt 201 (maximum of 400 u) for the treatment of ll spasticity according to the clinical judgment of the investigator. exclusion criteria: * fixed contracture defined as severe restriction of the range of joint movement on passive stretch or predominant forms of muscle hypertonia other than spasticity (e.g., dystonia) in the target limb(s). * surgery on pes equinus on side(s) intended to be treated with bont injections in this study within 12 months prior to screening visit (v1), in the screening period or planned for the time of participation in this study. * hip flexion requiring bont injection.
carnitine supplementation and bone mineral density

Conditions: Osteoporosis

Summary: the primary aim of the current research project is to explore whether carnitine supplementation and resistance training may prevent decrements in bone mineral density of aged women. a secondary aim of this project is to investigate the effect of supplementation on body composition and blood markers.

the study includes postmenopausal women. the subjects participate in resistance training (twice a week) for each session consisted of 6 exercises: horizontal seated leg press, seated chest press, leg extension, shoulder press, lat pull-down seated row, seated cable row. during the 24-weeks training programme participants are supplemented by carnitine with leucine, or leucine alone (placebo).

Eligibility criteria:
inclusion criteria: * postmenopausal * lack of restrictions to perform resistance exercises exclusion criteria: * cardiovascular disease * liver disease * kidney disease * neuromuscular disease * gastrointestinal disorders (including stomach ulcers and erosions) * diabetes * other severe chronic diseases
cost-effectiveness evaluation of the use of a patient specific instrument for surgical resection of malignant bone tumor within the pelvis versus the conventional surgical treatment

Conditions: Sarcoma, Bone Tumor

Summary: primitive malignant bone tumor or mixt tumor (compounded of soft tissues and bone) is a rare pathology particularly within the pelvis, the sacrum or the hip (between 25 and 80 new cases in france per year). the reference treatment is a surgical "en bloc" resection associated or not to a medical treatment. this surgery remains highly challenging because of the complex three-dimensional geometry of the pelvic bone and the proximity of important organs and neurovascular structures. the local recurrence rate is significantly increased when the resection does not respect a safe tissues margin (r0 margin). a new technology has been developed and used in different reference sites the patient specific instrument (psi), manufactured by 3d-side. the psi allows for a more secure and reliable surgical gesture, leading to more frequent r0 margins. the main objective of this study is to compare the efficiency of the psi for bone tumor resections within the pelvis with respect to the reference method.


Eligibility criteria:
screening critieria: retrospective group (reference) * patient already operated for the same indication as detailed in the prospective group inclusion criteria * surgery date within the 6 years before the study activation in the participating center * adult (18 years old or more) at the time of surgery inclusion criteria: prospective group (innovation) * primitive malignant pelvic bone tumor or mixt tumor (primary bone sarcoma, soft tissue sarcoma with bone extension, giant cells tumor of bone and any tumor requiring such a resection) * indication for a wide monobloc resection according to clinical guidelines of the pathology ("en bloc" resection of iliac bone including a bone section from periacetabular enneking zone 2 to the sacrum zone 4, hip extra-articular resection for proximal femur tumors and sacral tumor or ilio-sacral tumors that need a vertical osteotomy or horizontal osteotomy above s2) * ability to fill in euroqol and tess questionnaires * adult (18 years old or more) * health insurance holder retrospective group (reference) patient fulfilling the matching criteria with one patient of the prospective group, according to the following matching criteria (in order of importance): 1. tumor location (enneking zones 1, 2, 1-2, 2-3, 1-2-3, 1-2-4, 1-2-3-4, 1-4, sacrum) 2. tumor type (chondrosarcoma, osteosarcoma, ewing, chordoma, other tumor type) 3. surgery center 4. tumor size (as close as possible between both patients) 5. response to chemotherapy (good, bad, not applicable). exclusion criteria: prospective group (innovation) * patient suffering from a local recurrence or a metastasis at recruitment time * absence of informed consent * pregnancy or breastfeeding * minors * adults under guardianship or trusteeship retrospective group (reference) * patient not fulfilling the protocol matching criteria * refusal to participate

Keywords: pelvis surgical resection patient specific instrument
a study on improving detection and management of suicide risk among depressed patients in primary care

Conditions: Depression; Suicide

Summary: improve detection and management of suicide risk among depressed patients in primary care

after intervention of training on the identification and management of depression and suicide risk in primary health care professionals, the ability of detection and management of suicide risk among depressed patients in primary care is expected to be improved compared to baseline evaluation.

Eligibility criteria:
inclusion criteria: * consecutive outpatient exclusion criteria: * severe physical conditions

Keywords: suicide depressed patients primary care
the effect of kinesio tape on pain management in laparoscopic gynecological surgeries.

Conditions: Gynecological Laparoscopy

Summary: kinesio tapes have been used in medicine to reduce pain in various situations. it is an easy applicable and effective tape. the possible affect of this tape will be assessed in patients undergoing gynecological laparoscopic surgeries.

kinesio tape is frequently used for pain palliation in medicine including orthopedics, physical therapy and rehabilitation, and dentistry. recent studies show that it alleviates the amount of postoperative perceived pain in obstetrics and general surgery. in our study, we plan to contribute to the medical literature by studying its effect on pain palliation in patients undergoing laparoscopic gynecological surgery.

Eligibility criteria:
inclusion criteria: * being older than 18 years old female gender benign gynecologic conditions patients who underwent laparoscopic surgery patients who do not have any predisposing factors that aggreviate pain no history of malignancy no prior abdominal surgery patients who do not regularly take antiinflammatory medication patients who give permission to participate exclusion criteria: * being younger than 18 years old non-female gender having malignancies patients who underwent laparatomy patients with predisposing factors that aggrevate pain having prior abdominal surgery patients taking regular antiinflammatory medications who do not want to participate
nucleus freedom cochlear implant system pediatric post-approval study

Conditions: Sensorineural Hearing Loss

Summary: the objective of this multisite study is to evaluate the performance of the nucleus freedom cochlear implant system in a large population of sequentially implanted pediatric subjects.

the proposed study will include 50 pediatric subjects ages 1 year to 17 years, 11 months of age, implanted at up to 5 sites in the united states and canada. the estimated duration of this multisite study is 18 to 24 months. the duration of individual subject participation is not to exceed 12 months. the study will be conducted as a within-subject repeated measures experiment (in which each subject serves as his or her own control) in order to accommodate the heterogeneity that is well known to characterize hearing-impaired populations

Eligibility criteria:
inclusion criteria: * 1 year to 17 years, 11 months of age. * bilateral severe to profound sensorineural hearing loss for those 1 to 2 years of age. severe hearing loss for those 2 years of age and older. * limited benefit from bilateral hearing aids. limited benefit is defined as a lack of progress in the development of simple auditory skills in conjunction with appropriate amplification and intensive aural rehabilitation over a 3 to 6 month period. * for younger children, unable to take speech perception tests due to age-related cognitive and linguistic limitations, limited benefit will be quantified using the infant toddler meaningful auditory integration scale (it-mais)1 or meaningful auditory integration scale (mais)1. * for older children, capable of speech perception tasks, limited benefit is defined as £ 30% on the recorded open-set multisyllabic lexical neighborhood test (mlnt)2 or lexical neighborhood test (lnt) 2, depending on the child's cognitive and linguistic skills. * english spoken as a primary language. * willingness to participate in and to comply with all requirements of the protocol. exclusion criteria: * ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and tests including mri. * signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and tests including mri. * medical or psychological conditions that would contraindicate undergoing surgery (e.g., active middle ear infections, tympanic membrane perforation). * additional handicaps that would prevent or restrict participation in the evaluations. * unrealistic expectations on the part of the subject or subject's parents/guardians, regarding the possible benefits, risks and limitations that are inherent to the surgical procedure and prosthetic device. * unwillingness or inability of the candidate or candidate's parents/guardians to comply with all study requirements.

Keywords: bilateral severe to profound sensorineural hearing loss
carpal tunnel/amyloidosis blood sample study

Conditions: Carpal Tunnel Syndrome; Amyloidosis

Summary: carpal tunnel is an early manifestation of amyloidosis in a significant minority of patients. this specimen collection protocol will allow the investigators to screen patients with carpal tunnel syndrome for amyloidosis.

the investigators propose to assess a high risk population of patients, those with carpal tunnel syndrome, and systematically assess them for amyloid light-chain (al) amyloidosis and transthyretin-related amyloidosis (attr) with simple laboratory blood tests. the combination of serum immunofixation electrophoresis together with serum free light chain (flc) assay approaches 100% sensitivity for identifying the monoclonal protein underlying the illness in patients with al amyloidosis. in addition to this, testing for transthyretin gene mutations will allow the investigators to identify patients with attr. the investigators believe this simple screening panel (serum immunofixation and serum flc assay and transthyretin mutation analysis) may allow the investigators to identify patients early in the course of their disease, at which point the investigators can intervene with effective treatment and spare patients a significant amount of morbidity and mortality.

Eligibility criteria:
inclusion criteria: * 1. patients with diagnosed carpal tunnel syndrome based on electromyography (emg) results. * 2. patients with electrographic confirmation of median neuropathy at the wrist * 3. age ≥18 years * 4. ability to understand and willingness to sign a written informed consent document. exclusion criteria: * 1. patients receiving hemodialysis * 2. known amyloidosis
observational, real world study of inflectra in patients with inflammatory bowel disease

Conditions: Inflammatory Bowel Disease (IBD); Crohn's Disease (CD); Ulcerative Colitis (UC)

Summary: this is a prospective, observational, multicenter study conducted in adult patients with ulcerative colitis (uc) or crohn's disease (cd). the study plans to recruit 300 subjects in the united states and canada in which the participating physician has decided to treat with inflectra. the study will evaluate treatment patterns, adherence, disease activity, remission status, relapse status, treatment satisfaction, and healthcare resource utilization. patient outcomes will be assessed at four time points (quarterly) for approximately 52 weeks after the decision to initiate treatment with inflectra.


Eligibility criteria:
inclusion criteria: patients must meet all of the following criteria to be eligible for inclusion in the study: 1. patients with confirmed diagnosis of ulcerative colitis or crohn's disease. 2. evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. 3. patient eligible to receive inflectra for the treatment of their disease per approved drug label (patients with fistula, or stoma are eligible). exclusion criteria: -patients meeting any of the following criteria will not be included in the study: 1. patient previously failed treatment with remicade or inflectra/ct p13. 2. any reported contraindications for inflectra/ct p13 or remicade. 3. known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.

Keywords: inflectra remicade
study of low-density lipoprotein cholesterol (ldl-c) reduction using evolocumab (amg 145) in japanese patients with advanced cardiovascular risk

Conditions: Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events

Summary: the primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in ldl-c when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.

after a screening and placebo run-in period, eligible patients were randomized in a 1:1 ratio to 1 of 2 open-label background statin treatments (atorvastatin 5 mg or 20 mg daily \[qd\]) and entered a 4-week lipid stabilization period. after the lipid stabilization period, eligible patients were randomized in a 1:1:1:1 ratio to investigational product (evolocumab or placebo) for the 12-week treatment period. both randomizations were stratified by subject diagnosis and lipid-lowering therapy as follows: * current or prior diagnosis of heterozygous familial hypercholesterolemia (hefh) * no diagnosis of hefh and receiving intensive lipid-lowering therapy * no diagnosis of hefh and receiving non-intensive lipid-lowering therapy. a participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria including meeting final laboratory safety criteria, and undergoing both randomization procedures.

Eligibility criteria:
inclusion criteria: male or female, japanese adult, 20-85 years of age; subjects on stable dose of statin for greater than equal to 4 weeks; fasting ldl-c greater than equal to 100 mg/dl; fasting triglycerides less than equal to 400 mg/dl; subject is at high risk for cardiovascular events. exclusion criteria: new york heart association (nyha) iii or iv - heart failure; uncontrolled cardiac arrhythmia; uncontrolled hypertension; type 1 diabetes, poorly controlled type 2 diabetes; uncontrolled hypothyroidism or hyperthyroidism

Keywords: japanese, high cholesterol, ldl-c, high cardiovascular risk