Kornimate/medical-research-clean huggingface dataset:
efficacy and safety extension study of oral edaravone administered in subjects with als

Conditions: ALS

Summary: to evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (als), based on the time from the randomization date in study mt-1186-a02 to at least a 12-point decrease in revised als functional rating score (alsfrs-r) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country


Eligibility criteria:
inclusion criteria: 1. subjects or their legally authorized representative must provide a signed and dated informed consent form to participate in the study. 2. subjects must be able (in the judgment of the investigator) to understand the nature of the study and all risks involved with participation in the study. 3. subjects must be willing to cooperate and comply with all protocol restrictions and requirements. 4. subjects must have successfully completed all study mt-1186-a02 visits and have been compliant with study drug. exclusion criteria: 1. subjects of childbearing potential unwilling to use an acceptable method of contraception from the day 1/screening visit until 3 months after the last dose of study medication. subjects who are sexually active who do not agree to use contraception during the study period. 2. subjects who are female, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the day 1/screening visit. 3. subjects who have a significant risk of suicide. subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the columbia-suicide severity rating scale (c-ssrs) at week 48 of study mt-1186-a02. 4. subjects who are not eligible to continue in the study, as judged by the investigator in conjunction with the mtda medical monitor. 5. subjects who are unable to take their medications orally or through a peg/rig tube.
safety study of danazol with plasma exchange and steroids for the treatment of thrombotic thrombocytopenic purpura (ttp)

Conditions: Thrombotic Thrombocytopenic Purpura

Summary: the purpose of the study is to find out if administration of danazol with plasma exchange and corticosteroids will reduce the number of plasma exchanges required to control thrombotic thrombocytopenic purpura (ttp).

danazol is a synthetic steroid hormone structurally resembling a group of natural hormones (androgens)found in the body. danazol has immune modifying activity and is effective in treatment of blood disorders with low platelet counts such as idiopathic thrombocytopenic purpura (however fda has not yet approved danazol for this disorder). a study of danazol in conjunction with plasma exchange for thrombotic thrombocytopenic purpura showed that danazol decreased the number of plasma exchanges required by approximately 80% and reduced the time needed to control the disease. it's not clear how danazol works in ttp. it is not approved by the fda for the treatment of ttp.

Eligibility criteria:
inclusion criteria: * ttp with platelets less than 100,000 and microangiopathic hemolytic anemia * age greater than 18 and less than 60 * ldh \> 2x upper limit of normal * pt and ptt normal * patients must give signed informed consent * pre-menopausal woman must have negative pregnancy test. * ttp not related to underlying cancer, treatment of cancer or transplantation. * ttp not associated with drugs. exclusion criteria: * lfts ast/alt \> 2x upper limit of normal * hepatitis b and hepatitis c infection. * hiv with active opportunistic infections * acute or chronic disseminated intravascular coagulation (dic), defined as d-dimer 8ug/ml and fibrinogen\<100 mg/dl * ttp related to drugs, malignancy and transplantation. * pregnancy * concurrent other investigational drug use during this study. * porphyria.

Keywords: ttp thrombotic thrombocytopenic purpura
1. study to evaluate the efficacy/safety of bremelanotide in premenopausal women with hypoactive sexual desire disorder

Conditions: Hypoactive Sexual Desire Disorder

Summary: a phase 3, randomized, double-blind, placebo-controlled, parallel-group trial with an optional open-label extension to evaluate the efficacy of bremelanotide (bmt), administered subcutaneously (sc) on an as needed basis for the treatment of hsdd (with or without decreased arousal) in premenopausal females.

this will be a multicenter, randomized, placebo-controlled, parallel group study in up to 80 sites in the united states of america (usa) and canada to evaluate the efficacy and safety of a fixed dose of sc bmt versus placebo on an as-needed basis under conditions of home use in premenopausal women with hsdd (with or without decreased arousal). the study will consist of 2 phases: (1) core study: 4-week no-treatment qualification period, a 4-week single-blind placebo treatment period (baseline), and a 24-week double-blind treatment period where participants will self-administer placebo or bmt 1.75 mg sc via an autoinjector; and (2) extension phase: a 52-week open-label treatment period during which all subjects will receive bmt 1.75 mg. primary objective • to evaluate the efficacy of bremelanotide (bmt), administered subcutaneously (sc) on an as needed basis for the treatment of hsdd (with or without decreased arousal) in premenopausal females. secondary objectives * to evaluate the efficacy of bmt in premenopausal women in the double-blind core study, as assessed by subject responses to questionnaires measuring sexual function, treatment satisfaction, and distress associated with sexual dysfunction. * to evaluate the safety of bmt in premenopausal women in the double-blind core study. * to evaluate the safety of long-term therapy with bmt in the open label extension phase. * to evaluate the efficacy of long-term therapy with bmt in the open-label extension phase.

Eligibility criteria:
main inclusion criteria: * has met diagnostic criteria for hsdd for at least 6 months * is willing and able to understand and comply with all study requirements * has a normal pelvic examination at screening main exclusion criteria: * subjects should be generally healthy premenopausal females with no psychological, gynecological or urological conditions which might contribute to the sexual dysfunction, compromise study participation, or confound interpretation of the study results * not currently under treatment for the sexual dysfunction and willing to forego other treatments through the course of the clinical trial

Keywords: hsdd female sexual desire disorder
effect of allopurinol on markers of mineral and bone metabolism

Conditions: Chronic Kidney Diseases; Osteodystrophy; Uric Acid Concentration, Serum, Quantitative Trait Locus 7

Summary: hyperuricemia is a common condition in patients with chronic kidney disease (ckd) in the glomerular filtration rate. recently, it has been suggested that uric acid is related to a mineral and bone disease of ckd (ckd-mbd) since the high concentration of uric acid is associated with the harmful effect of vitamin d. the proof of concept of the association between acid uric acid and ckd-mbd is based on a prospective study (sample size 6) that observed, after 1 week of use of allopurinol, an increase in the concentration of 1,25(2d, a result independent of the concentration of calcium, phosphorus, 25(oh)d and pth. an experimental study found that hyperuricemia could modify the expression of the 1α-hydroxylase enzyme, consequently reducing 1,25(oh). the current study aims to evaluate the action of allopurinol on ckd-mbd biomarkers (25(oh)-vitamin d, 1,25(oh)2d, fgf-23, pth, calcium and phosphorus). we hypothesize that allopurinol can improve serum levels of 1,25(oh) 2d and pth. this is a controlled, randomized, double-blind study, defined as a filtration rate \ 20 ng/ml. exclusion criteria: patients diagnosed with gout, undergoing treatment with allopurinol, patients already in use and drugs with sensitivity to the drug. based on a previous study, we calculated a sample for 2 groups (placebo and drug) with pre and post-measurements (a total of 4). considering a standard deviation of 4 and a difference of 7 in the treated group, 3 in the placebo group, and an alpha error of 5%, we calculated a sample of 25 patients in each arm.

in this randomized double-blind study, patients receive allopurinol or a placebo for 3 months. dependent variables: 25(oh)-vitamin d, 1,25(oh)2d, fgf-23, pth, calcium and phosphorus population: stage 3, 4 or 5 ckd on conservative management at the nephrology service of hospital das clinicas hcfmusp, sao paulo, brazil. the same physician will follow patients. adverse effects will be recorded.

Eligibility criteria:
inclusion criteria: stage 3, 4 or 5 ckd on conservative management - exclusion criteria: * allergy to allopurinol * current treatment with allopurinol * gout

Keywords: chronic kidney disease allopurinol mineral and bone metabolism uric acid vitamin d
a study of ro5093151 in patients with ocular hypertension or open angle glaucoma

Conditions: Hypertension, Glaucoma, Open-Angle

Summary: this randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of ro5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. patients will be randomized to receive oral doses of ro5093151 or placebo twice daily. the anticipated time on study treatment is 7 days with the possibility to extend to 28 days.


Eligibility criteria:
inclusion criteria: * adult patients, at least 21 years of age, inclusive * diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye * able to participate and willing to give informed consent exclusion criteria: * presence of extreme narrow angle with complete or partial closure * progressive retinal or optic nerve disease from any cause other than glaucoma * history or signs of penetrating ocular trauma * uncontrolled hypertension * clinically significant abnormalities in laboratory test results * positive test results on hepatitis b, hepatitis c, or hiv 1 and 2 * kidney disease or dysfunction
antibacterial effect of paradontax toothpaste

Conditions: Plaque Induced Gingivitis; Plaque, Dental

Summary: the purpose of the study is to test the antibacterial effect of parodontax toothpaste on plaque formation, and thus gingivitis compared to placebo toothpaste. each subject will be given 2 plastic splints that are individually adapted to their quadrant 1 and 2. in the splint in the 1st quadrant, parodontax test toothpaste will be placed, while in the splint in the 2nd quadrant, regular toothpaste will be placed, which the subject uses daily. each person's set of teeth is otherwise professionally cleaned.

each subject will be given 2 plastic splints that are individually adapted to their quadrant 1 and 2. in the splint in the 1st quadrant, parodontax test toothpaste will be placed, while in the splint in the 2nd quadrant, regular toothpaste will be placed, which the subject uses daily. each person's teeth is otherwise professionally cleaned. home procedure: the subject first rinses the mouth with water for 30 sec. then both splints are placed on the teeth in the 1st quadrant and 2nd quadrant, respectively, and the rest (lower jaw) is brushed with the subject's regular toothpaste. the brace should be on for 1 min while cleaning the teeth in the lower jaw as usual, with its usual commercial toothpaste. after 1 minute, rinse your mouth with water for 30 seconds. then the splints are removed and the mouth is immediately rinsed with water for another 30 sec. the procedure is repeated twice a day (morning and evening) for 3 weeks (21 days). in this way, the test person becomes his own control (1st quadrant versus 2nd quadrant), and the individual plaque quality is subordinate to what it would not otherwise be in a 2-group study. furthermore, individual brushing technique will not be an issue, as we only test the antibacterial effect of the toothpaste in the splint quadrants. it is the antibacterial effect of parodontax we test, not affected by brushing technique. health information that includes age, medication use, allergies, diseases, and tobacco use. following the test period, registration of plaque (silness\&loe/quigley\&hines) and gingival bleeding (loe\&silness) will be registered

Eligibility criteria:
inclusion criteria: healthy people of both sexes * age 18-35 years * have at least three of the following teeth: 16, 15, 14, 13, 23, 24, 25, 26 with healthy gingiva. * non-smokers * has signed an informed consent document exclusion criteria: pregnancy and breast-feeding. * any chronic disease clinical or other symptoms of oral disease * any prescribed or over-the-counter systemic or topical medication with the exception of oral contraceptives used within one week prior to the start of the study. * haematological and clinical / chemical parameters considered unacceptable by the project manager. * use of antibiotics within the last three months before the start of the study. * alcohol or drug / drug abuse * participation in other clinical studies in the last 4 weeks before the start of the study.

Keywords: split mouth chemical plaque control
egypt hypertension study

Conditions: Different Classes of the Antihypertensive Treatment

Summary: this study is an epidemiological non-interventional trial that aims to evaluate standard daily practice in managing patients with arterial hypertension. the trial only records real-life clinical practice with no additional diagnostic or monitoring procedures. the study is purposed to collect the following egypt-specific epidemiology data on hypertension: demographic data, patients' characteristics, and patients' management/treatment in order to reach its rationale.

this study is aimed to evaluate response rate of the antihypertensive treatment with thiazide diuretics, calcium antagonist, angiotensin converting enzyme inhibitor, angiotensin ii receptor blocker, and beta blocker in real life practice, and to collect the following egypt-specific epidemiology data on hypertensive patients: demographic data, patents characteristics, and patients' management/treatment. approximately 300 sites will be participating (1 investigator per site; 300 investigators). patients that are to be enrolled will either be newly diagnosed with hypertension, or on current antihypertensive treatment, compiling a total of 3000 patients (21 years, or older). the study will be conducted in two sequential phases; the first phase will include 150 sites from cairo, giza and alexandria aiming to reach 1500 patients followed by a second phase which will include 150 sites from delta and upper egypt aiming to reach 1500 patients. epidemiological data collection will take place at a single visit and laboratory investigations will be requested in the first visit. patients will be followed for 3 visits with the investigator. the investigator will complete a patient record form (prf) with the patient's data: demographics, history, current antihypertensive drug treatment/treatment changes, results of physical examination, blood pressure (sbp/dbp), heart rate.

Eligibility criteria:
inclusion criteria: * males or female aged \>21 years * subject population with newly diagnosed essential arterial hypertension * subject population with essential arterial hypertension currently receiving treatment with any of the following antihypertensive classes: a thiazide diuretics, calcium antagonist, angiotensin converting enzyme inhibitor, angiotensin ii receptor blocker and beta blocker for at least 3 months. * females of childbearing potential must use a reliable method of contraception. * subject willing to give written informed consent exclusion criteria: * if participating in any clinical trial, the subject cannot take part in this study. * pregnancy and lactation. * patients not willing to give informed consent.
prevalence study of iron deficiency in patients with cancer

Conditions: Iron-deficiency

Summary: despite its high prevalence, a recent study conducted by prof. cacoub (unpublished) on the french national health insurance database showed that iron deficiency was an underdiagnosed and under-treated co-morbidity. in inflammatory situations, especially during cancer, the measurement of the transferrin saturation factor is only performed in about 10% of cases whereas this measure is recommended in inflammatory situations including cancer (french health high authority 2011)


Eligibility criteria:
inclusion criteria: * patient, male or female, over the age of 18 * patient in an oncology department (any type of tumor, any type of treatment, initiated or not) * patient affiliated or beneficiary of a social security system * patient with written consent exclusion criteria: * protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision * patient hospitalized without consent
effectiveness of continuous glucose monitoring system among cardiac surgery patients

Conditions: Cardiac Disease; PreDiabetes; Diabetes Mellitus

Summary: the aim of this study is to assess the level of glycemic control and the incidence of surgery-related complications in cardiac patients post-surgery when continuous glucose monitoring (cgm) is utilized, as compared to traditional methods of arterial/venous blood sampling and point-of-care testing (poct) for glucose monitoring.


Eligibility criteria:
inclusion criteria: * subjects waiting for elective cardiac surgery (cabg, cardiac valve operation, congenital heart anomaly surgery, aortic surgery, etc.) * subjects over the age of 18 * patients with type 2 diabetes * patients with prediabetes 1. hba1c 5.7% or more 2. fasting blood glucose 100 mg/dl or more 3. 2 hours 75g-ogtt 140 mg/dl or more exclusion criteria: * emergency surgery patients * patients performing co-operation other than cardiac surgery * patients with type 1 diabetes * total pancreatectomy patients * patients with high surgical severity (sts score of 8 or more or euro score of 5 or more) * patients who do not consent to the study * severe patients who are deemed difficult to continue research during surgery (excluded at the researcher's discretion) 1. cases where severe weight gain and severe edema occur after surgery 2. cases where the surgery time is significantly longer than average 3. cases where cardiopulmonary bypass is used more than once during surgery * others who are deemed unsuitable for research progression at the researcher's discretion

Keywords: continuous glucose monitoring
abc program in patients with metabolic syndrome

Conditions: Weight Reduction in Patients With Metabolic Syndrome

Summary: aims: we evaluate the efficacy of the "active body control (abc) program" for weight reduction in patients with metabolic syndrome. methods: the abc program combines telemonitoring of the physical activity with a low-calorie diet also preferring carbohydrates with low glycemic indexes. in this 12-month, randomized, clinical trial 60 patients will be treated according to the abc program and 60 control patients will receive standard therapy.


Eligibility criteria:
inclusion criteria: * metabolic syndrome exclusion criteria: * tumor cachexia
a study of vx-445 in healthy subjects and subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is a first-in-human and proof-of-concept study of vx-445. the study includes 6 parts. parts a, b, and c were conducted in healthy subjects. parts d, e, and f were conducted in subjects with cystic fibrosis (cf) who are homozygous for the f508del mutation of the cf transmembrane conductance regulator (cftr) gene (f/f genotype), or who are heterozygous for the f508del mutation and a minimal function (mf) cftr mutation not likely to respond to tez, iva, or tez/iva (f/mf genotypes).


Eligibility criteria:
key inclusion criteria: parts a, b, and c: * female subjects must be of non-childbearing potential. * between the ages of 18 and 55 years, inclusive. * body mass index (bmi) of 18.0 to 32.0 kg/m2, inclusive, and a total body weight \>50 kg parts d, e, and f: * body weight ≥35 kg. * subjects must have an eligible cftr genotype: * parts d and f: heterozygous for f508del and an mf mutation (f/mf) * part e: homozygous for f508del (f/f) * fev1 value ≥40% and ≤90% of predicted mean for age, sex, and height. key exclusion criteria: parts a, b, and c: * any condition possibly affecting drug absorption. * history of febrile illness within 14 days before the first study drug dose. * glucose-6-phosphate dehydrogenase (g6pd) deficiency. parts d, e, and f: * history of clinically significant cirrhosis with or without portal hypertension. * glucose-6-phosphate dehydrogenase (g6pd) deficiency. * lung infection with organisms associated with a more rapid decline in pulmonary status. * history of solid organ or hematological transplantation. other protocol defined inclusion/exclusion criteria may apply.
evaluation of gastrointestinal symptoms and quality of life in patients with sphincter of oddi dysfunction

Conditions: Sphincter of Oddi Dysfunction; Abdominal Pain

Summary: the purpose of this research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch.

sphincter of oddi is a complex muscular structure which regulates the biliary and pancreatic outflow into the duodenum. resting pressures \>40mm of hg are considered abnormal. individuals with elevated resting/basal biliary or pancreatic sphincter pressures are thought to have sphincter of oddi dysfunction. sphincter dysfunction often manifests as pain and the nature of the pain is dependent on the involvement of either the biliary or the pancreatic sphincter. in most instances the pain is debilitating and could impair the quality of life. endoscopic therapy- either biliary or pancreatic sphincterotomy, is often performed for relief of symptoms. data regarding the efficacy of such an approach are limited. a recent systematic review by the cochrane reviewers has found only two randomized controlled trials evaluating the efficacy of sphincterotomy for relief of symptoms in those with sphincter of oddi dysfunction and there were no data evaluating the quality of life or the health economics of such an approach.

Eligibility criteria:
inclusion criteria: * over age 18 * suspected history and clinical features suggestive of sphincter of oddi dysfunction exclusion criteria: * prior history of endoscopic therapy for sphincter of oddi dysfunction * no proven sphincter of oddi dysfunction on manometry

Keywords: sphincter of oddi dysfunction