Kornimate/medical-research-clean huggingface dataset:
the correlation between degeneration of paraspinal muscle and outcome of patients with lumbar spinal stenosis

Conditions: Lumbar Spinal Stenosis; Paraspinal Muscle

Summary: the photographical and functional parameters of paravertebral muscle in patients with lumbar spinal stenosis will be measured to investigate the correlation between paravertebral muscle degeneration and symptoms and prognosis of patients.by measuring the parameters of paravertebral muscle with normal people, the differences between the patients and normal people will be compared to establish an appropriate paravertebral muscle evaluation method.

it is a prospective observational study. this study will recruit 200 patients with lumbar spinal stenosis who will undertake posterior lumbar decompression and fusion surgery in our hospital.they all take preoperative lumbar mri examination and waist and back muscle strength test as well as recording their preoperative visual analogue scale,oswestry disability index, lumbar stiffness disability index score.all patients will receive a follow-up lasting for 1 year,and we will record patients outcomes,such as visual analogue scale,oswestry disability index and lumbar stiffness disability index score at each follow-up time. at the same time,we will recruit 100 healthy subjects without lumbar diseases or chronic lumbar pain. the difference of their age with patients was less than 5 years. meanwhile, lumbar dorsal muscle strength test and lumbar mri examination were conducted, and visual analogue scale as well as oswestry disability index and lumbar stiffness disability index score was recorded in healthy subjects.

Eligibility criteria:
inclusion criteria: * patients with lumbar spinal stenosis * age\>45 years old * without other spinal disease * without history of former spinal surgery exclusion criteria: * with neuromuscular diseases * with hip joint or knee joint disease * acute or severe chronic back pain of spinal stenosis that could interfere with the evaluation of endurance * other serious diseases impacting the evaluation of endurance

Keywords: degeneration of paraspinal muscle lumbar spinal stenosis
post marketing surveillance on the safety and tolerability of sunitinib malate (sutent) for filipino patients

Conditions: Metastatic Renal Cell Carcinoma

Summary: the primary purpose is to monitor the safety and tolerability and effectiveness of sunitinib malate in the treatment of patients with metastatic renal cell carcinoma and gastrointestinal stromal tumor among filipino patients in usual clinical practice setting.

open label

Eligibility criteria:
inclusion criteria: * age 18 years and above * diagnosed with metastatic renal cell carcinoma or gastrointestinal stromal tumor after imatinib treatment failure or intolerance exclusion criteria: * subjects with conditions that are contraindicated with sunitinib malate

Keywords: imatinib resistant or intolerant
study to evaluate safety and efficacy of vx-661 in combination with ivacaftor in subjects with cystic fibrosis, homozygous for the f508del-cftr mutation with an open-label expansion

Conditions: Cystic Fibrosis

Summary: the objective of this study was to evaluate the safety and efficacy of vx-661in combination with ivacaftor in participants with cystic fibrosis (cf) who are homozygous for f508del cystic fibrosis transmembrane conductance regulator (cftr) mutation


Eligibility criteria:
inclusion criteria: * homozygous for the f508del cftr mutation * fev1 ≥40% and ≤90% of predicted normal for age, sex, and height * stable cf disease as judged by the investigator exclusion criteria: * history of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant * pregnant and nursing females: females of childbearing potential must have a negative pregnancy test at screening and day 1 of the pc phase and day -7 or day 1 of the ole phase (whichever was applicable) * sexually active participants of reproductive potential who are not willing to follow the contraception requirements * the participant or a close relative of the participant is the investigator or sub investigator, research assistant, pharmacist, study coordinator, or other staff directly involved with the conduct of the study.

Keywords: cf
the global shoulder concept (gsc) method versus classic physical therapy for shoulder tendinitis

Conditions: Shoulder; Tendinopathy

Summary: the primary objective of this study is to demonstrate the superiority of the cge physical therapy protocol versus a standard physical therapy protocol of the shoulder by measuring the following after 1 month of physical therapy: the fi2s score including validated measures of pain, glenohumeral joint range of motion in the three planes, the ability to perform certain everyday activities and the strength of forward elevation measured with a dynamometer.

secondary objectives: * to study the evolution of passive glenohumeral range of motion * to study the evolution of the global range of passive and active motion for each method used * to evaluate functional recovery (dash) * to evaluate the impact on quality of life (sf36) * to study the difference in visual analog scale scores for pain during physical therapy sessions * compare the two methods/groups after three months.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * painful, chronic tendinopathy (more than 3 months) of the rotator cuff, confirmed by mri exclusion criteria: * the patient is pregnant or breastfeeding * any emergency situation * non-mechanical tendinopathies (metabolic, neurological, capsulitis, reflex sympathetic dystrophy) and tendon surgery (tendon surgery and acromioplasty)

Keywords: comparison of physical therapy strategies
mk0928 study in adult patients with primary insomnia (0928-040)(completed)

Conditions: Primary Insomnia

Summary: a study to evaluate the efficacy, safety and tolerability of mk-0928 in primary insomnia.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of primary insomnia exclusion criteria: * patients with an active psychiatric disorder other than primary insomnia
effect of standard normothermia protocol on surgical site infections

Conditions: Surgical Site Infection

Summary: aim of this study is to investigate the efficiency of a standard normothermia protocol and effects on postoperative surgical site infection (ssi) rate.


Eligibility criteria:
inclusion criteria: * elective * preoperatively not infected/dirty surgical site * open major abdominal operations (hepatobiliary, upper gastrointestinal or colorectal); under general anesthesia, longer than 30 minutes) exclusion criteria: * emergent surgery * local/locoregional procedures * laparoscopic operation * minor abdominal operations (e.g. hernia repair, colostomy closure) * malign hyperthermia * signs of active infection or fever * immunosuppression * severe malnutrition * kidney/liver failure and antibiotic use within the previous 1 week or immunosuppressive use (chemotherapy, steroids.) within the previous 1 month and reversal of patients opinion while randomization period

Keywords: surgical site infection normothermia hypothermia prewarming
the physiology of human brown adipose tissue

Conditions: Adipose Tissue, Brown; Adipose Tissue; Obesity

Summary: brown fat is a type of fat, found in both children and adults, which can produce heat and regulate the body's metabolism and energy use. white fat is the more common type of fat which is used to store extra calories. understanding more about differences between brown and white fat may allow us to develop new approaches to improve the body's metabolism.

the overarching goal of this study, is to map fat (adipose) tissue differences in humans. the investigators will probe multiple aspects of fat cell (adipocyte) identity by integrating quantitative chemical imaging, single-cell and single-nucleus rna sequencing (sc and snrnaseq), and site-specific collection of adipocytes and adipocyte precursors. deidentified data from these studies will be submitted to the human cell atlas. the investigators anticipate that these studies will ultimately increase understanding of mechanisms by which fat (adipose) tissue regulates systemic metabolism (energy transformation in the body), and promotes risk for metabolic disease. knowledge gained from this research may be used to set the stage for disease-specific analyses, and aid in the development of personalized medicine for metabolic diseases such as type 2 diabetes.

Eligibility criteria:
inclusion criteria: 1. healthy participants between age 18 and 75 years undergoing planned clinically indicated procedure at bidmc. exclusion criteria: 1. body mass index (bmi) greater than or equal to 40 kg/m2 2. history of any local or systemic infectious disease with fever or requiring antibiotic within four weeks of drug administration; 3. diabetes, either previously diagnosed or hemoglobin a1c greater than or equal to 6.5% 4. use of oral or parenteral corticosteroids (epidural permitted) or other medication known to cause insulin resistance in the previous 6 weeks. 5. willingness to provide informed consent and follow study procedures, including attending scheduled visits. 6. chronic kidney disease stage 4 or 5 (including end-stage renal disease); 7. hepatic disease, including serum alanine aminotransferase (alt) or aspartate transaminase (ast) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \ 2.0; 8. active malignancy (except squamous or basal cell carcinoma of skin) 9. bleeding disorder, treatment with anticoagulants (if not discontinued prior to surgery), or platelet count \<50,000; 10. current addiction to alcohol or substances of abuse; 11. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation; 12. use of an investigational drug within 30 days prior to screening. 13. there will be no involvement of special vulnerable populations such as fetuses, neonates, pregnant women, children, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations. 14. because the goal is to study adult human brown adipose tissue, children are not eligible to participate.

Keywords: human cell atlas
vitamin d supplementation in individuals with a chronic spinal cord injury

Conditions: Spinal Cord Injuries; Vitamin D Deficiency

Summary: the main objective of this placebo-controlled randomized double-blinded study is to investigate the effect of vitamin d supplementation on vitamin d status (25(oh)d concentration in the blood) among individuals with a chronic spinal cord injury (sci). further, the effects of vitamin d supplementation on several other parameters (e.g. bone density and mood) are investigated, which could reveal positive secondary effects of supplementation that are especially relevant for clinical practice.

the purpose of this study is to evaluate the influence of vitamin d supplementation among individuals with chronic sci. the primary aim is to study whether different dosages (24'000 iu/month or 48'000 iu/month) of vitamin d supplementation over 12 months will lead to differences in vitamin d status as well as differences in several other outcomes. the use of a placebo group supports the evaluation of dose-response effects of vitamin d supplementation on the primary outcome (vitamin d status) and secondary outcomes (including bone density and mood) that are not only supported by randomized controlled trial standards but also informative in clinical practice.

Eligibility criteria:
inclusion criteria: * informed consent to the present study as documented by a signature * chronic (\> 3 years) traumatic or non-traumatic spinal cord injury with a sub-c4-level lesion * wheelchair dependency during activities of daily living * vitamin d status \<75nmol/l exclusion criteria: * contraindications to the investigational product * clinically relevant disorders, * pressure ulcer grade 3 or 4 * pregnancy, breastfeeding * vitamin d supplementation (\> 400 iu/day) within the last 12 months * visiting a country with increased sun exposure (below the 37th parallel north) within the last month before study enrolment or during the study * fractures in both arms and/or both legs within the last five years
evaluation of post operative pain after ultrasonic activation and manual dynamic agitation as final irrigation protocols during root canal treatment

Conditions: Post Operative Pain

Summary: the study analyzes the difference in post operative pain after root canal therapy, after using different activation protocols and devices. the subjects are divided into 2 groups and a different activation protocol is used in each group. in one group, final activation of irrigating agent during root canal therapy is done with an ultrasonic activation device, and in the other group, manual dynamic agitation is done using master gutta percha cone. the post operative pain is then compared at 8, 24,and 48 hour intervals

root canal therapy is a procedure in which inflamed pulp tissue and microorganisms are removed from root canals and pulp chamber, in order to eradicate infection and symptoms. irrigation is a crucial step of an endodontic therapy and different methods and protocols are used to enhance the efficacy of irrigation. ultrasonic activation of root canal irrigation agent is one of the effective methods that enhance the outcomes and success rate of endo therapies. it removes the smear layer, bacterial biofilms and debris by acoustic streaming and agitating the irrigant inside root canals. similarly, a conventional method of agitation (manual dynamic agitation) also play an important role in endodontic therapy, particularly by improving the delivery of irrigation agent to the apex of a root canal. the later method involves agitation of irrigant with master gutta percha cone with continuous to and fro strokes manually. in this study, the efficacy of both the different irrigation protocols will be compared and assessed based on post-operative pain, measured by visual analog scale (vas).

Eligibility criteria:
inclusion criteria: 1. patients with unremarkable/ noncontributory medical history 2. healthy persons between the ages of 18 and 60 years 3. maxillary and mandibular molar teeth diagnosed with symptomatic irreversible pulpitis. 4. patients not having taken any medication for 6 hours before treatment 5. no allergies to the drugs or dental material being used in the treatment exclusion criteria: 1. patients who had taken analgesics on anti-inflammatory drugs within the last 12 hours 2. pregnant women and patients with immunocompromised health state 3. patients having severe malocclusion associated with traumatic occlusion 4. teeth with calcified canals 5. teeth with periapical radiolucency 6. teeth with root resorption 7. teeth previously undergone root canal treatment
comparison of myoinositol and metformin in pco

Conditions: PCOS

Summary: aim of the study is to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with pcos or having oligo/amenorrhea, reduction in weight and bmi, improvement in the biochemical and clinical profile of patients with the polycystic syndrome. the secondary outcome measured will be the rate of pregnancy, miscarriage and term pregnancy among these patients inducted in the study. it will be a three-arm prospective double-blind study. this clinical trial will be registered in public registry. this rct will be based on consort statement. the patient coming to gynecology opd will be randomized into 3 groups group a ( metformin 500 mg tds), group b( myoinositol 2mg x bd ), group c.(both metformin,\& myoinositol).each group will take folic acid and will be asked for lifestyle modifications.

pcos is a common endocrine disorder in women of reproductive age associated with insulin resistance. metformin and myo-inositol being insulin sensitizers improve biochemical parameters. it is aimed to compare the effect of myoinositol and metformin in the resumption of the spontaneous menstrual cycle in patients diagnosed with pcos or having oligo/amenorrhea, reduction in weight and bmi, improvement in the biochemical and clinical profile of patients with the polycystic syndrome. inclusion criteria: will be based on the rotterdam criteria of diagnosing pco. patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of pco will be included in this group. patients with history of hyperprolactinemia, cushing's disease, hypothyroidism/ hyperthyroidism, pregnancy and nursing, established type 1 or type 2 diabetes mellitus, any history of drug intake e.g. anti-diabetic or estrogen and progesterone, history of treatment for the same complaint taken in the last 3 months, unable to come for regular follow-ups, any pathological cause of bleeding e.g. fibroid, polyp, cervical pathology and known allergic to these drugs would be excluded.

Eligibility criteria:
inclusion criteria: it will be based on the rotterdam criteria of diagnosing pco. patients presenting with a history of secondary amenorrhea, irregular menstrual cycle, oligomenorrhea, weight gain, hirsutism, and already diagnosed cases of pco will be included in this group. exclusion criteria: * hyperprolactinemia * cushing's disease * hypothyroidism/ hyperthyroidism * pregnancy and nursing * established type 1 or type 2 diabetes mellitus * any history of drug intake e.g. anti-diabetic or estrogen and progesterone * history of treatment for the same complaint taken in the last 3 months * unable to come for regular follow-ups * any pathological cause of bleeding e.g. fibroid, polyp, cervical pathology * known allergic to these drugs
systems biology of gastrointestinal and related diseases

Conditions: Ulcerative Colitis; Crohn Disease; Obesity; Colon Polyp; Eosinophilic Esophagitis; GERD; Gastro Esophageal Reflux; Barrett Esophagus; Esophageal Cancer; Gastritis; Gastric Ulcer; Duodenal Ulcer; Intestinal Metaplasia; Gastric Cancer; Lymphocytic Colitis; Microscopic Colitis; Celiac Sprue; IBS; Irritable Bowel Syndrome; SIBO; NAFLD; Gallstone Disease

Summary: this is a longitudinal observational study on patients with gastrointestinal and related disease. the study will be conducted for at least 10 years, following each participant over time, as they either go through relapses and remissions, or progression of their disease.

this is a longitudinal, observational study whose main goal is to identify the human and microbial determinants of gastrointestinal diseases. molecular and metadata will be collected from a large study population at multiple time points. machine learning will be applied to all data, and models will be evaluated for development of novel diagnostic and therapeutic tools.

Eligibility criteria:
inclusion criteria * any patient 18 years old or older that schedules a visit to wagi clinics or endoscopy center * able to use electronic communications * able to communicate in english * consent to participate in the study exclusion criteria: * none

Keywords: gastrointestinal disease gastric upset
nir fluorescent molecular probe for the identification of breast tissue

Conditions: Breast Cancer

Summary: accurate evaluation of tumor boundaries in breast-conserving surgery is critical to reducing the second operation of patients. near-infrared (nir) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. however, very effective probes can be applied to clinical trials up to now, which limits the clinical application of fluorescence imaging. here we developed a new technology that can quickly identify the tumor area of the resected breast tissue during the operation and distinguish the tumor boundary. in brief, the breast tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the tumor boundary. the accuracy of fluorescence imaging was confirmed by pathological diagnosis.

after enrollment, the patients received surgical treatment according to clinical diagnosis and treatment. during the operation, the excised breast tissue was incubated, and the specific procedure was as follows. 1. preparation of the incubation solution: the probe was dissolved in phosphate buffer saline(pbs) buffer as the incubation solution at room temperature in the dark. 2. in vitro incubation of fresh breast cancer tissues: the fresh excision breast cancer tissues were completely soaked in the incubation solution for about 10 minutes, followed by 5 minutes rinse with pbs buffer and drying with the use of absorbent paper. 3. analysis of the images in the "digital precision medicine(dpm)" nir-ii system. the dpm parameter was set up before scaling. then fluorescence imaging was performed with the dpm nir-ii system. and the result was analyzed to identify the tumor area and distinguish the tumor boundary. 4. confirmed the diagnosis by pathological examination.

Eligibility criteria:
inclusion criteria: * adult patients over 18 years of age; female; patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment; good operative candidate; subject capable of giving informed consent and participating in the process of consent. exclusion criteria: * patients unable to participate in the consent process; patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc; other conditions that the researcher considers inappropriate to participate in the study.

Keywords: breast tissue; nir-ii; trop-2; diagnosis
laparoscopic bariatric surgery: impact of deep neuromuscular block on surgical conditions

Conditions: Bariatric Surgery; Laparoscopic Bariatric Surgery; Robotic Bariatric Surgery; Gastric Bypass; Morbid Obesity

Summary: the purpose of this study is to determine whether deep neuromuscular blockade compared to moderate neuromuscular blockade may improve the surgical conditions in patients undergoing laparoscopic bariatric surgery.


Eligibility criteria:
inclusion criteria: * patient between 18 and 64 years * indication for bariatric surgery accordingly to has * patient undergoing laparoscopic or robotic gastric bypass surgery * written informed consent * affiliation to social security non-inclusion criteria: * known hypersensibility to any of the drugs used during this study * absence of written informed consent

Keywords: bariatric surgery surgical conditions deep neuromuscular blockade