Kornimate/medical-research-clean huggingface dataset:
a single dose study to investigate the pharmacokinetics of mk-0941 in participants with renal insufficiency (mk-0941-015-02)

Conditions: Type 2 Diabetes

Summary: this study will assess the pharmacokinetics of mk-0941 in participants with varying degrees of renal insufficiency.


Eligibility criteria:
inclusion criteria: * male or nonpregnant female age 18 to 75 years * female of childbearing potential on appropriate method of contraception * body mass index (bmi) less than or equal to 40 kg/m2 * participant is in good health * participant diagnosed with type 2 diabetes * participant agrees to follow smoking restrictions * willing to follow the study diet restrictions exclusion criteria: * mental or legal incapacitation * participant has had kidney removed * history of type 1 diabetes * history of stroke, chronic seizures or major neurological disorder * history of neoplastic disease * nursing mother * consumes greater than 4 glasses of alcoholic beverages per day * consumes greater than 6 servings of caffeinated beverages per day * participant has had surgery or donated 1 unit of blood within 1 month of screening * participant has history of recent eye infection within 2 weeks of study drug administration * clinically diagnosed with glaucoma or blindness * has trauma to one or both eyes
carbohydrate counting in adults with type 1 diabetes treated with continuous subcutaneous insulin infusion

Conditions: Diabetes Mellitus, Type 1; Insulin Pump, Programmable

Summary: the investigators postulate that carbohydrate (cho) counting in adult patients with type 1 diabetes mellitus (t1dm) treated with continuous subcutaneous insulin infusion (csii) may improve glycemic control, glycemic variability and quality of life.

this study was designed as a randomized, controlled (versus standard education), open, one-center trial. patients in group 1 were taught carbohydrate counting to estimate insulin preprandial bolus, while the patients in group 2 followed standard education. primary outcome (glycosylated hemoglobin, hba1c) and secondary outcomes (fasting glucose, glycemic variability, insulin requirement, body mass index (bmi), waist circumference, quality of life) were measured at baseline, 3, and 6 months.

Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * age 18-65 * continuous subcutaneous insulin infusion for at least 3 months exclusion criteria: * patients who have already been trained in carbohydrate counting * known hypothyroidism not on replacement therapy * renal disease (serum creatinine \>1.4 mg/dl in females and \>1.7 mg/dl in males) * patients with celiac disease * pregnancy * serious diseases or disabilities which may interfere with study assessments

Keywords: carbohydrate counting continuous subcutaneous insulin infusion type 1 diabetes mellitus
a phase 3, multi site, randomized, double blind, placebo controlled study of the efficacy and safety comparing cp- 690,550 and etanercept in subjects with moderate to severe chronic plaque psoriasis

Conditions: Psoriasis

Summary: to evaluate the efficacy of cp-690,550 as compared to etanercept and the safety of cp-690,550 for treatment of moderate to severe chronic plaque psoriasis.


Eligibility criteria:
inclusion criteria: * have had a diagnosis of plaque type psoriasis (psoriasis vulgaris); * have plaque-type psoriasis covering at least 10% of total body surface area * considered by dermatologist investigator to be a candidate for systemic therapy or phototherapy of psoriasis exclusion criteria: * non-plaque or drug induced forms of psoriasis * cannot discontinue current systemic and/or topical therapies for the treatment of psoriasis * cannot discontinue phototherapy * any uncontrolled significant medical condition

Keywords: cp-690,550 etanercept moderate severe chronic plaque psoriasis efficacy safety tofacitinib xeljanz opt compare opt head-to-head non-inferiority psoriasis vulgaris short-term itch pruritus plaque psoriasis dlqi
proclaim-cx-072: a trial to find safe and active doses of an investigational drug cx-072 for patients with solid tumors or lymphomas

Conditions: Solid Tumor; Lymphoma

Summary: the purpose of this first-in-human study of cx-072 is to characterize the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd) and antitumor activity of cx-072 administered intravenously (iv) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. proclaim-cx-072: probody clinical assessment in man cx-072 clinical trial cx-072 is a probody® therapeutic directed against pd-l1 (programmed cell death ligand 1). probody therapeutics are proteolytically-activatable antibodies (abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. probody therapeutics are "masked" to attenuate binding to target in healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific protease activity. probody is a u.s. registered trademark of cytomx therapeutics, inc.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy 2. agreement to provide mandatory archival tissue or fresh biopsy. 3. at least 18 years of age. exclusion criteria: 1. prior therapy with a chimeric antigen receptor (car) t-cell containing regimen. 2. history of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any probody therapeutic. 3. active or history of uveal, mucosal, or ocular melanoma. human immunodeficiency virus (hiv) or acquired immune deficiency syndrome (aids)-related illness, chronic hepatitis b or c. 4. history of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus. 5. history of syndrome or medical condition(s) that requires systemic steroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications. 6. history of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant. 7. chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug. 8. major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.

Keywords: cancer checkpoint inhibitor monotherapy combination pd-l1 ctla-4 solid tumor lymphoma braf proclaim cx-072 proclaim-cx-072
study of thymosin beta 4 in patients with venous stasis ulcers

Conditions: Venous Stasis Ulcers

Summary: the purpose of this study is to evaluate the safety, tolerability and effectiveness of thymosin beta 4 administered topically in patients with venous stasis ulcers

the purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of thymosin beta 4 (tβ4), administered topically, in patients with venous stasis (vs) ulcers. vs ulcers develop on the ankle or lower leg in patients with chronic vascular disease. in these patients, blood flow in the lower extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. tβ4 is a synthetically-produced copy of a naturally occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Eligibility criteria:
inclusion criteria: * informed consent form signed by the patient * male or female, between 18 and 79 years of age * at least one venous leg ulceration stable for at least 6 weeks before enrollment * surface area between 3 and 30 cm2 exclusion criteria: * have clinical evidence of active infection on the index ulcer * use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment * use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment * history of adverse reaction to any ingredients of the study medication * clinically significant neurological, cardiovascular, respiratory, hepatic, renal, metabolic and dermatologic disease other than venous ulcers * current or former malignancy * arterial disorder resulting in ulcerated ulcers * diabetes mellitus * pregnant or lactating (breastfeeding) women. a serum pregnancy test will be performed at screening for female patients of childbearing potential

Keywords: venous stasis ulcers venous insufficiency leg ulcers thymosin beta 4 laminin-5
efficacy of cannabinoids in amyotrophic lateral sclerosis or motor neurone disease

Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Summary: this is a randomised, double-blind, placebo controlled study on a cannabis-based medicine extract (medicabilis cbd oil), in patients with amyotrophic lateral sclerosis or motor neurone disease. participants will be randomised in a 1:1 ratio to receive medicabilis cbd oil or placebo oil. the treatment duration is 6 months with one-month safety follow up. participants will be checked every month either face to face or via telephone and will be assessed to collect data for study objectives such as alsfrs-r, forced vital capacity, pain and spasticity score, and quality of life. thirty (30) participants will be randomised.


Eligibility criteria:
inclusion criteria: 1. affected by als/mnd, either of definite or probable according to the el escorial revised criteria 2. can provide written informed consent 3. able and willing to comply with all study requirement 4. male or female, ages 25-80 years old 5. onset of first symptom within the last 2 years 6. forced vital capacity (fvc) of at least 60% on baseline exclusion criteria: 1. participants who are bedridden 2. have used or taken cannabis or cannabinoid-based medications within 30 days of study entry 3. history of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia 4. heavy consumption of alcohol or use of illicit drug 5. hypersensitivity to cannabinoids or any of the excipients 6. any of the following: egfr \ 5 x uln 7. unwillingness of a female participant of child bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter 8. pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter 9. received any investigational drug or medical device within 30 days prior randomisation 10. any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study 11. inability to cooperate with the study procedures 12. unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug. 13. close affiliation with the study team, e.g. close relative of the investigator
efficacy of natural vitamin e tocotrienol on the treatment of surgical scars

Conditions: Scar

Summary: the overall goal of this study is to determine the efficacy of tocotrienol (tct), a natural form of vitamin e, in preventing or reducing scar formation in human skin wounds as well as the basal levels of tct in normal human skin and adipose tissue.

scar formation is the physiological and inevitable end point of mammalian wound healing and there is substantial evidence that inflammation is an essential prerequisite for scarring. although scar tissue restores the normal skin barrier, the new tissue is inferior in structural, aesthetic, and functional respects. the mammalian wound healing response may have originated during the time of high susceptibility to infection. therefore, we may have developed speed optimized wound healing where a multiple redundant compensating rapid inflammatory response allows the wound to heal quickly without infection. the scar is then the price mammals have to pay for evolutionary survival after being wounded. tocotrienol may be an effective tool to prevent or reduce normal, hypertrophic, or keloid scarring by mediating the inflammatory response. tocotrienol is a safe and convenient treatment that could be used by mouth or topically. there has never been a study on the effectiveness of tocotrienol in preventing or reducing scar formation.

Eligibility criteria:
inclusion criteria: * 18 years of age or older. * non- smoker * no current medications that alter liver metabolism (e.g., phenobarbital, hmg co-a inhibitors, etc.) * non- pregnant or non-breastfeeding * no current use of dietary supplements containing vitamin-e * not actively abusing drugs or alcohol exclusion criteria: * under 18 years of age * prisoners * current smoker * pregnant or breastfeeding * hiv diagnosis * viral hepatitis diagnosis * immunosuppressive therapy * actively abusing drugs or alcohol * current use of dietary supplements containing vitamin-e

Keywords: single and bilateral body contouring surgical sites.
effects of gluten digestion with alv003

Conditions: Celiac Disease

Summary: this is a phase 0, double-blind study that will assess the effect of in vitro treatment of gluten with alv003 or with placebo when ingested by cd subjects.

the primary objective of this study is to compare the effects of gluten treated with alv003 vs placebo: * the clinical response by symptom measurement before and after oral challenge * the immune response measured by elispot testing and serology the secondary objective of the study is to * describe the immunotoxic epitope profile of gluten digests with alv003 compared with placebo

Eligibility criteria:
inclusion criteria: * age 18-75 years * well controlled celiac disease without flare in symptoms for the past 8 weeks * history of biopsy proven celiac disease * able and willing to complete a symptom diary for 3 days prior and through 3 days post gluten challenge * been on a gluten free diet for 8 weeks prior to study entry * have normal celiac serology (anti- ttg level of \<20 units/ml) exclusion criteria: * uncontrolled complications of celiac disease which in the opinion of the investigator would impact their immune response, or pose an increased risk to the subject. (example: like type 1 diabetes or other autoimmune disease) * pregnant or breast feeding women, subjects of childbearing potential to use two methods of contraception * concomitant medications such as over the counter digestive enzymes, immunosuppressive therapies, anticoagulants, nsaids. chronic medications for well-controlled chronic conditions are allowed. * clinically significant abnormal lab values, as determined by the pi: * untreated or active peptic ulcer disease, esophagitis, motility disorders or any gastrointestinal diseases. * positive pregnancy test within 7 days prior to study drug administration * known allergy or hypersensitivity to e.coli or e.coli derived proteins

Keywords: celiac disease
spinal cord injury leg rehabilitation

Conditions: Spinal Cord Injury; Paraplegia; Quadriplegia; Tetraplegia

Summary: the purpose of this study is to determine if individuals with incomplete spinal cord injury (sci) who remain unable to walk normally 1 year after their scis are able to sense and move the affected legs better after 10-13 weeks of treatment with a new robotic therapy device. the hypothesis is that using the ames device on the legs of chronic subjects with incomplete sci will result in improved strength, sensation in the legs, and improved functional gait in the treated limbs.

traumatic spinal cord injury (sci) affects over 200,000 people in the usa, with several thousand new injuries each year. most recovery, following sci, occurs in the six months following surgery. further recovery after 12 months is unusual. in this study 10 subjects, more than 1 year post injury, will be enrolled to test the safety and efficacy of a new type of robotic therapy device known as the ames device. the aim of this phase i/ii study is to investigate the use of assisted movement and enhanced sensation (ames) technology in the rehabilitation of the legs of participants with incomplete sci.

Eligibility criteria:
inclusion criteria: * paraplegia or tetraplegia due to sci * at least 1 year post incomplete spinal cord injury * can tolerate sitting upright for at least one hour * capable of weight-bearing and taking a step with or without an assistive device * on the asia sensory function (light touch), a score of at least 1 at the l4 and l5 level * primary asia motor criterion (pamc) a total score of 4-12 for hip extensors, knee extensors, ankle dorsiflexors and ankle plantarflexors, with a minimum score of 1 for each of these muscles in the qualifying leg exclusion criteria: * fracture of the treated limb resulting in loss of range of motion * concomitant tbi or stroke (patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study), or other neurological injury or disease * dvt of the treated extremity * peripheral nerve injury of the treated extremity * osteo- or rheumatoid-arthritis limiting range of motion * contractures equal to or greater than 50% of the normal rom * skin condition not tolerant of device or sitting upright * progressive neurodegenerative disorder * botox treatment of the treated extremity in the prior 5 month * chronic itb therapy * uncontrolled seizure disorder * uncontrolled high blood pressure/angina * pain in affected limb or exercise intolerance * participation in another therapy or activity-based program * combined score on asia motor function for knee extensors, ankle dorsiflexors and ankle plantarflexors outside the range of 3-9

Keywords: incomplete spinal cord injury rehabilitation ames device lower extremity gait paraplegia
lidocaine and analgesia after laparoscopic cholecystectomy

Conditions: Postoperative Pain; Opioid Consumption

Summary: the purpose of this study is to evaluate how effective is the intraoperative use of lidocaine to attenuate postoperative pain and opioids consumption after laparoscopic cholecystectomy

acute postoperative pain may predict the development of chronic pain.recently, the analgesic effect of lidocaine, as a part of a multimodal analgesia, has been evaluated in many studies. they have shown that lidocaine may have a role in the postoperative pain management, as an adjunct. acute postoperative pain after laparoscopic cholecystectomy is complex in nature. postoperative pain is the main complaint and the primary reason for delay discharge after laparoscopic cholecystectomy.the study includes patients undergoing laparoscopic cholecystectomy.

Eligibility criteria:
inclusion criteria: * asa physical status i-ii * age ≥ 18 years old * bmi ≤ 35 exclusion criteria: * allergy in local anesthetics * history of liver, kidney or heart failure * existence of chronic pain history or daily analgesics * psychiatric disorders * inability to understand pain assessment

Keywords: lidocaine postoperative pain opioid consumption laparoscopic cholecystectomy
efficacy of epidiolex in patients with electrical status epilepticus of sleep (eses).

Conditions: Electrical Status Epilepticus of Slow-Wave Sleep

Summary: this study aims to assess the efficacy of epidiolex in patients with eses. eses is characterized by sleep potentiated spikes with a spike index greater than 85% (conventional definition) and 50% (new definition)1. several drugs including: steroids, intravenous gama globulin, clobazam, other benzodiazepines, valproic acid, and other anti-epileptic drugs have been tried with mixed benefits2,3. cannabidiol (cbd) would provide a novel mechanism of action to assess for its efficacy in this population. this will be a double-blind placebo-controlled crossover clinical trial.

this study attempts to view the effect of epidiolex on subjects with electrical status epilepticus of sleep (eses). eses can cause various types of seizures which can fluctuate during sleep. similar studies have been conducted with epidiolex with other seizure disorders such as lennox-gastaut syndrome (lgs) and dravet syndrome. since there is no data available on the effect of cannabidiol (cbd) on patients with eses, this study hopes to fill that void. as such, patients that have been diagnosed with eses will be eligible to participate in this study to ascertain whether or not epidiolex can reduce the frequency or intensity of the seizures brought on by eses during sleep.

Eligibility criteria:
in order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. provision of signed and dated informed consent form 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. male or female, aged 2-17 years old 4. in good general health as evidenced by medical history or diagnosed with eses. "good health" in relation to this study is understood as stable without current seizures requiring immediate hospitalization. 5. ability to take oral medication and be willing to adhere to the epidiolex/placebo regimen 6. for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 month after the end of oral epidiolex administration 7. for males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner exclusion criteria:an individual who meets any of the following criteria will be excluded from participation in this study: 1. previous use of cannabidiol within 4 months. 2. pregnancy or lactation 3. known allergic reactions to components of the epidiolex: cannabidiol, sesame seed oil, and sucralose 4. febrile illness within 1 month of screening 5. treatment with another investigational drug or other intervention within 6 months 6. current smoker or tobacco use within 6 months

Keywords: neurology pediatric eses