Kornimate/medical-research-clean huggingface dataset:
a master protocol study (ly900028) of multiple intervention-specific-appendices (isas) in participants with chronic pain

Conditions: Osteoarthritis, Knee; Diabetic Neuropathic Pain; Chronic Low-back Pain

Summary: the purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (dsa) and intervention-specific appendices (isas). the isas may start independently of other isas as interventions become available for clinical testing.

the chronic pain master protocol (cpmp) establishes entry criteria and includes dsa for osteoarthritis of the knee, chronic low back pain, and diabetic peripheral neuropathic pain. the dsa have specific study elements to appropriately define the target population and unique scales for assessment. also, the master protocol governs isas that may start independently of other isas as interventions become available for clinical testing. note: results for all outcomes are posted in the intervention records. no need for duplication.

Eligibility criteria:
inclusion criteria: * have a visual analog scale (vas) pain value \>40 and \<95 at screening and prerandomization screening. * have a history of daily pain for at least 12 weeks based on participant report or medical history * have a value of ≤30 on the pain catastrophizing scale * have a body mass index \<40 kilogram/square meter (kg/m²) (inclusive) * are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and will not start any new nonpharmacologic pain-relieving therapies during study participation. * are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study exclusion criteria: * have second- or third-degree atrioventricular (av) heart block or av dissociation or history of ventricular tachycardia * have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques) * have surgery planned during the study for any reason, related or not to the disease state under evaluation. * have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation. * have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision. * have fibromyalgia * have substance use disorder as defined by the diagnostic and statistical manual of mental disorders (5th edition; dsm-5; american psychiatric association) * have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ecg), or clinical laboratory test results that could be detrimental to the participant or could compromise the study. * have a positive human immunodeficiency virus (hiv) test result at screening * have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.
edmond - elemental diet in bowel obstruction

Conditions: Ovarian Cancer; Ovarian Neoplasms; Ovarian Disease; Peritoneal Neoplasms; Peritoneal Diseases; Metastatic Ovarian Cancer; Primary Peritoneal Carcinoma; Abdominal Neoplasm; Bowel Obstruction

Summary: a feasibility study to provide 'proof of concept' of elemental diet (ed) as an acceptable/ useful feeding option for patient with inoperable malignant bowel obstruction and to examine the impact of ed on quality of life

the aim of this study is to determine whether elemental diet (a type of drink that contains an elemental protein source known as amino acids) can be tolerated by patients with inoperable bowel blockage who can no longer eat and are only able to swallow small amount of fluid. the objective is to find out whether elemental diet (ed) can be used as an acceptable nutrition and whether it improves the quality of life. bowel blockage is a common complication in patients with ovarian cancer. unfortunately when the cancer is advanced, this blockage can occur in many parts of the bowel therefore surgery is not possible. every year in the uk some publications report the rate as high as 50% . one way to feed patients with bowel blockage is through the veins; this is known as parenteral nutrition (pn) however pn is rarely used in united kingdom. patients with malignant bowel blockage are often able to swallow small amounts of liquid but if they have no pn they are only able to survive for 2-3 weeks and the psychological as well as physical impact on patients and the family are very distressing. ed is a type of a drink which contains an elemental protein source known as amino acids. ed drinks are almost totally absorbed in the upper part of the bowel and therefore could be absorbed even in patients who have bowel blockage which usually develops lower down in the gut. if this study is successful and proves that ed can be tolerated and provide nutrition to patients with inoperable bowel blockage it will be a big step towards improving the quality of life at the final stage of cancer.

Eligibility criteria:
inclusion criteria: * age \> 18 years * confirmed inoperable bowel obstruction due to disseminated malignancy * ability to tolerate 500ml of liquid * capacity to give informed consent exclusion criteria: * bowel obstruction that can be managed with surgical intervention * complete bowel obstruction and inability to tolerate small amount of liquid

Keywords: feasibility elemental diet quality of life palliative nutrition ovarian peritoneal advanced metastatic bowel obstruction inoperable
investigating medication vs. prostatic urethral lift: assessment and comparison of therapies for bph

Conditions: BPH

Summary: this prospective, multicenter, two-arm, 1:1 randomized controlled trial (rct) will enroll approximately 250 males at approximately 25 sites located within the united states. all enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (bph). they will be randomized to one of two readily available, marketed bph therapies; prostatic urethral lift procedure with the urolift system (pul arm) or 0.4mg tamsulosin hcl (med arm).

this prospective, multicenter, two-arm, 1:1 randomized controlled trial (rct) will enroll approximately 250 males at approximately 25 sites located within the united states. all enrolled subjects will be 45 years of age or older diagnosed with symptomatic benign prostatic hyperplasia (bph). they will be randomized to one of two readily available, marketed bph therapies; prostatic urethral lift procedure with the urolift system (pul arm) or 0.4mg tamsulosin hcl (med arm).men 45 or older diagnosed with symptomatic benign prostatic hyperplasia (bph). bph symptoms may range from mild (8) to severe (35) on the ipss scale. all enrolled men must meet selection criteria and be candidates for therapy with both urolift system and 0.4 mg tamsulosin hcl.

Eligibility criteria:
inclusion criteria: 1. male 45 years of age or older 2. diagnosis of bph 3. experiencing symptoms of bph as indicated by an ipss ≥8 and ≤30 4. willing to wash out of current bph medication(s), as applicable 5. an appropriate candidate for both bph therapies evaluated in this study. 6. ability to understand and consent to participate in this study 7. willing and able to participate in follow-up evaluations exclusion criteria: 1. use of alpha blocker for bph unless washed-out for 30 days 2. use of daily phosphodiesterase type 5 inhibitor (pde5i) for bph unless washed-out for 30 days 3. 5-alpha-reductase inhibitors for bph used within 6 months of therapy initiation 4. current urinary tract infection or prostatitis 5. current gross hematuria 6. urinary incontinence presumed due to incompetent sphincter 7. catheter-dependent urinary retention within 1 month prior to enrollment 8. prostate volume greater than 100 cc as measured by trus 9. prostate specific antigen level of greater than 10 ng/ml within one year of enrollment unless prostate cancer has been ruled out 10. history of neurogenic or atonic bladder 11. history prostate cancer treatment 12. known to be hypersensitive to tamsulosin hcl or any component of tamsulosin hcl capsules 13. known allergy to nickel, titanium, or stainless steel 14. prior minimally invasive or surgical intervention for bph 15. urethral conditions that may prevent insertion of delivery system into bladder. 16. currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint 17. history of medical, surgical or other conditions that, in the opinion of the investigator, would interfere with the treatment or evaluation of the subject
study on novel strategies for cervical cancer screening using photoelectric detection and epigenetic procotol

Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia

Summary: a national multicenter, open randomized controlled study was conducted. it is planned to invite 30 multi-center units across the country to compete for enrollment, and each multi-center will enroll 140 patients meeting colposcopic indications (70 in the conventional group and 70 in the experimental group), totaling 4200 patients. enrolled subjects were randomly divided into two groups. methylation test + colposcopic biopsy was performed in the conventional group, and clinical follow-up was performed according to the methylation results; in the experimental group, methylation test + colposcopic biopsy +oits was performed, and clinical follow-up was performed according to the methylation results and oits results. to verify the effectiveness of methylation tests and oits in screening for cin2+, whether they can reduce missed diagnosis of cin2+, whether they can flag excessive colposcopic procedures, and the value of clinical follow-up for cervical lesions.


Eligibility criteria:
inclusion criteria: 1. women between the ages of 18 and 65 who have already had sex life 2. hpv16, 18 positive or high-risk hpv infection with cytology ≧asc-us 3. no history of cervical cancer and cervical physical therapy, a complete cervix 4. no menstrual period, no sexual activity and vaginal medication within 48 hours 5. the vagina or cervix is not in a stage of acute inflammation 6. willing to participate in the study with full informed consent exclusion criteria: 1. cervical dysplasia (congenital malformation or double uterus, etc.) 2. history of cervical treatment (coning, ablation, or photodynamic therapy) 3. there are definite immunosuppression conditions, such as hiv infection or organ transplantation 4. patients with severe bleeding diseases such as coagulation abnormalities or photosensitive diseases (such as porphyria, lupus erythematosus, etc.) 5. a history of radiation or chemotherapy (e.g., pelvic radiation therapy) with cancer at other sites 6. the patient is in pregnancy or puerperium 7. the other conditions of this study were not considered appropriate by the researchers
early administration of lactose-free milk in children presenting with acute diarrhea

Conditions: Acute Diarrhea

Summary: the purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes.

diarrhea is still the most important cause of mortality and morbidity in children of the developing countries. we evaluated the effectiveness of early administration of lactose free milk in the management of acute diarrhea in children below two years old.

Eligibility criteria:
inclusion criteria: 1. children with acute non-bloody diarrhea (≤ 2 weeks) 2. mild to moderate dehydration exclusion criteria: 1. mucous bloody stools 2. major systemic illness 3. severe malnutrition (weight for age \<60% and weight for height \<70 %) 4. history of antibiotics receiving

Keywords: diarrhea, lactose, milk, weight, acute.
effects of azd5004 in adults who are living with obesity or overweight with at least 1 weight-related comorbidity

Conditions: Obesity or Overweight

Summary: a phase iib, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of azd5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index \[bmi\] ≥ 30 kg/m2), or overweight (bmi ≥ 27 kg/m2) who have at least 1 weight-related comorbidity

this is a phase iib, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of azd5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (bmi ≥ 30 kg/m2), or overweight (bmi ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (hypertension, dyslipidemia or hyperlipidemia, cv disease and/or obstructive sleep apnea). approximately 304 participants will be randomized in the study. the dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.

Eligibility criteria:
inclusion criteria: * adults ≥ 18 years of age. * bmi of (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated): (i) hypertension (ii) dyslipidemia or hyperlipidemia (iii) cv disease (iv) obstructive sleep apnea * a stable body weight for 3 months prior to screening (± 5% body weight change). exclusion criteria: * have obesity induced by other endocrine disorders, such as cushing's syndrome or monogenic or syndromic obesity such as prader-willi syndrome. * has received prescription or non-prescription medication for weight loss within the last 3 months prior to screening. * previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier). * history of type 1 diabetes mellitus or type 2 diabetes mellitus. * clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper gi tract. * history of acute or chronic pancreatitis.
a study to evaluate the safety and effectiveness of evicel as an adjunct to sutured dural repair

Conditions: Dura Defects

Summary: the objective of this study is to evaluate the safety and efficacy of evicel for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.

this is a randomized, multi-center controlled study evaluating the effectiveness of evicel\* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.

Eligibility criteria:
inclusion criteria: * patient undergoing elective craniotomy/craniectomy * age greater than or equal to 18 years * patients who are able and willing to comply with the procedures required by the protocol. * signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures. exclusion criteria: * chemotherapy or radiation therapy within 7 days following surgery. * conditions compromising the immune system. * known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product. * female subjects of childbearing potential with a positive pregnancy test prior to surgery. * female subjects who are breastfeeding or intend to become pregnant during the clinical study period. * participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment. * major intraoperative findings or complications identified by the surgeon that may preclude conduct of the planned surgical procedure.

Keywords: fibrin sealant csf leak
a drug interaction study of simvastatin and albiglutide

Conditions: Diabetes Mellitus, Type 2

Summary: this open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. the primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.

this phase i open-label study evaluates the pharmacokinetics of simvastatin when coadministered with albiglutide in healthy adult subjects. the primary objective is to assess the effect of albiglutide doses on the pharmacokinetics of simvastatin.

Eligibility criteria:
inclusion criteria: * no clinically significant diseases or clinically significant abnormal laboratory values * females must be of non-childbearing potential * body mass index (bmi) is \>/=18 kg and ≤30 kg/m2 * nonsmoker * negative drug screen exclusion criteria: * positive test results for hepatitis b, hepatitis c or human immunodeficiency virus (hiv) * any clinically relevant abnormality * female subject is pregnant or breast-feeding * history of any anaphylactic reaction to any drug * history of significant cardiovascular or pulmonary dysfunction * current or chronic history of liver disease * history of alcohol or substance abuse * history of thyroid dysfunction or disease * history of gastrointestinal surgery or disease * history of pancreatitis * previously received any glp-1 mimetic compound (e.g., exenatide)

Keywords: albiglutide simvastatin healthy volunteers pharmacokinetics
effect of percutaneous needle electrolysis (pne) on tendinopathy

Conditions: Posterior Tibial Tendon Dysfunction

Summary: the aim of this study is to test the efficacy of percutaneous electrolysis in posterior tibial tendinopathies. the posterior tibial tendon injury is one of the most frequent pathologies in the lower extremities, and therefore a correct study and evaluation of it is necessary. this study aims to compare the therapeutic effect of percutaneous electrolysis comparing a control group with an experimental group. to evaluate functionality, pain and its ultrasound pattern before and after treatment, in order to assess the efficacy of the treatment.

a single-blind, longitudinal, randomised, controlled, single-blind, longitudinal, randomised, controlled clinical trial will be conducted. first, the participant will receive a foot and ankle ability (faam) survey, along with a numerical pain scale, both of which must be completed. next, an ultrasound study of the foot will be performed, focusing on pain in the inner ankle, to check for possible pathology in the posterior tibial tendon. finally, the physiotherapist's intervention will be carried out to check the effectiveness of the technique, which may cause some pain, and finally, the numerical pain scale will be passed again. four sessions will be carried out in four different weeks, always using the same day of the week for the intervention and following the same steps as above. the purpose of this study is to test the efficacy of pd in posterior tibial tendinopathy and whether pd is therefore a safe technique for this type of intervention. all patients will sign an informed consent form and will be informed about the study beforehand.

Eligibility criteria:
inclusion criteria: * subjects over 18 years of age * mild inflammation, swelling and/or tenderness posterior to the medial malleolus * pain posterior and/or superior to the medial malleolus, aggravated by activity * pain present for at least 3 weeks * one or more signs of flexible flatfoot deformity, including excessive valgus deformity of the hindfoot during weight bearing and/or excessive foot abduction (many toes sign). * pain when performing the hell rise test or performed incorrectly. * signs of tenosynovitis on ultrasound examination. as the inclusion criteria are based on side-to-side comparison all participants had to have unilateral involvement. exclusion criteria: * previous surgery on the affected foot, leg or knee. * disabling osteoarthritis of the knee on the affected side. * fixed hindfoot deformities. * recurrent ankle sprains on the affected side. * ligament tears or bony abnormalities of the affected foot. * a physical or medical condition that contraindicates the testing protocol. * pregnancy. * fcd or flh tendinopathy.
electronically connected health coaching in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: patients with type 2 diabetes randomly allocated to the intervention arm (health coaching + smartphone-based health promotion software) will have significantly better hemoglobin a1c levels at 6 months post-intervention than patients with type 2 diabetes allocated to the control arm (health coaching alone).

inclusion criteria: all participating patients have been diagnosed with type 2 diabetes, are between 25 and 70 years of age, have a regular primary care physician, and have hba1c levels \> or = to 7.3. exclusion criteria: axis i and ii psychiatric disorders. primary outcome: hba1c at 6 months follow up. secondary outcome: centre for epidemiological studies depression scale

Eligibility criteria:
inclusion criteria: * clinical diagnosis of type 2 diabetes * fluency in english and/or spanish exclusion criteria: * \> 75 years of age

Keywords: diabetes
comparative study of intraoperative mri-guided vs. conventional glioma surgery

Conditions: Glioma

Summary: excision to the maximum possible extent marks the first step of glioma surgery. depending on tumour histology, adjuvant treatment consists of radio- and/or chemotherapy. multi-centre studies have shown that the presence of residual tumour according to mri-criteria is a prognostic factor in this incurable condition. in order to improve the extent of resection, several methods, in particular intraoperative imaging techniques, have become available to demonstrate already during surgery whether the goal of surgery has been achieved. the intraoperative mri devices currently available differ in their magnetic field strengths and image resolution, but also in their amount of interference with the surgical workflow. prospective, high-class evidence data to promote the use of intraoperative mri in glioma surgery are lacking. to assess whether the rate of radiologically complete tumour resections can be improved by using intraoperative mri-guidance, we designed this prospective, randomized trial. we hypothesized that the extent of resection that can be achieved using an intraoperative mri is greater than that of conventional microsurgical tumor resection.


Eligibility criteria:
inclusion criteria: * known or suspected contrast-enhancing glioma (primary and recurrent) * location of the tumor permits intended gross-total resection exclusion criteria: * tumor location prohibits or questions gross-total resection * contraindications to undergo mri examinations

Keywords: intraoperative mri glioma surgery extent of resection