Kornimate/medical-research-clean huggingface dataset:
cohort study to refine the positioning of closed-loop therapy versus islet transplantation in the management of patients with unstable type 1 diabetes

Conditions: Type 1 Diabetes (T1D)

Summary: prospective, multicenter, descriptive cohort (riph3 study under the jardé act), stabiloop study aims to describe whether bf may be an appropriate therapeutic option for the cohort of patients who are theoretically candidates for islet transplantation, by describing closed-loop failures at 12 months in patients referred to an expert center for management of unstable diabetes.


Eligibility criteria:
inclusion criteria: type 1 diabetic patients describing: * significant glycaemic variability defined by the presence of one of these 3 criteria: - standard deviation \> 50% of the glycaemic mean or a mage index \> 60 mg/dl * coefficient of glycaemic variation \> 36% * lbgi index \> 5 or hyposcore \> 800 * this glycaemic variability must be persistent, i.e. persist for more than 12 months despite optimal diabetes management by a multi-professional team. optimum management involves : * monitoring by a team with expertise in insulin pump and glucose sensor technologies * training patients in functional insulin therapy, intensive self-monitoring of blood glucose levels, and prevention and management of situations where there is a risk of hypoglycaemia * use of pump and glucose sensor therapy, with interruption before hypoglycaemia * reinforced multi-professional support and monitoring, possibly combined with support via telemedicine. * this glycaemic variability must be considered as severe, i.e. causing unpredictable clinical and metabolic events that impair quality of life, such as severe, disabling and frequent hypoglycaemia (at least 2 severe hypoglycaemia with assistance from a third party in the last 12 months or at least 1 severe hypoglycaemia with life-threatening consequences in the last 12 months (coma, convulsions or trauma)) or ketosis ketoacidosis. exclusion criteria: * patients with type 1 diabetes who do not meet the criteria for islet transplantation * patients already fitted with a closed loop * kidney transplant patients * persons covered by articles l1121-5 to l1121-8 of the csp (corresponding to all protected persons) * persons opposed to participation in research

Keywords: islet transplantation closed loop
major depressive disorder study in adults

Conditions: Major Depressive Disorder

Summary: a study to obtain safety and tolerability data


Eligibility criteria:
inclusion criteria: * patient must have primary diagnosis of major depressive disorder (mdd). * discontinued a selective serotonin reuptake inhibitor (ssri)or serotonin-norepinephrine reuptake inhibitor (snri) regimen due to intolerability. * minimum time frame between last dose of previous antidepressant and initiation of study drug is one week. * maximum time frame between last dose of prior antidepressant and initiation of study drug is 2 months. exclusion criteria: * patient has previously been treated with the study drug. * is experiencing an adverse event attributed to previous ssri/snri use that has not been resolved at least one week prior to baseline visit. * has a history of seizure disorder. * has met criteria for substance abuse or dependence within 6 months prior to baseline visit. * currently using an antidepressant. * currently pregnant.

Keywords: major depressive disorder open-label discontinued
real world treatment experience of patients with breast, lung, or gi cancer or multiple myeloma using remote symptom monitoring

Conditions: Breast Cancer; Lung Cancer; Gastrointestinal Cancer; Multiple Myeloma

Summary: the carevive registry collects patient characteristics, patient symptoms, and treatment experience data from patients receiving cancer treatment for breast, lung, gi or multiple myeloma. for this study, a core set of variables is collected on each patient in the carevive platform. patients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. weekly electronic patient reported outcome surveys are collected from the patients using the carevive platform for a minimum of 12 weeks. patients may continue weekly surveys as long as they are receiving treatment.


Eligibility criteria:
inclusion criteria: * all participants must be 18 years of age or older. * subjects may be any stage and anywhere in the treatment continuum. * subject participants must have a diagnosis of breast, lung, gi or ovarian cancer or multiple myeloma. * subjects must be able to complete on-line surveys using a cell phone, tablet, or computer. * all participants must be able to understand english. exclusion criteria: * any patient who cannot understand written or spoken english. * any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer. * any patient on a treatment clinical trial. * any prisoner and/or other vulnerable persons as defined by nih (45 cfr 46, subpart b, c and d).
effectiveness of hydroxychloroquine in covid-19 patients

Conditions: COVID19

Summary: to find the effectiveness of hydroxychloroquine alone and adjuvant with azithromycin in mild to severe covide-19 pneumonia patients admitted to coronavirus cell/ward of ayub teaching hospital, abbottabad pakistan. a single centered, single-blind randomized control trial study.

coronavirus (sars-ncov-2) is a member family coronaviridae, order nidovirales. it is single-stranded, positive sense enveloped rna discovered in early 1960s. coronavirus pandemic put a lot of lives at stake. by 19 march 2020, a total of 219238 confirmed cases with 8967 being dead and 85742 recovered cases have been reported. worldwide, in 9 days, the confirmed death cases have been doubled. the average death rate of covid-19 per day is approximately 88 patients as of the given date. unlike, sars-cov and mers-cov, the disease progression and mortality rate of covid-19 is startling. the pre-pathogenic course of novel covid-19 is yet to be determined, so the risk factors, clinical picture and medical intervention too. only supportive therapy is being practised. yet many trials of antimalarial drug, chloroquine and quinolone is currently taking place worldwide. according to cortegiani a, 23 ongoing trials from china have been registered. clinical experience from recent wuhan epidemic came up with promising results of chloroquine and hydroxychloroquine in covid-19 positive patients. some in-vitro studies suggest that these immunomodulant drugs can interfere with sars-ncov-2 replication. these are federal drug authority approved medicine for malaria. yet their effectiveness and safety in treating covid-19 pneumonia is a question mark.

Eligibility criteria:
inclusion criteria: * confirmed cases of covid-19 (all by rt-pcr from same laboratory) * mild to severe clinical presentation (identified at the time of admission to ward by national early warning score news-2; mild 0-4; severe 5-6) exclusion criteria: * covid-19 critically ill patients (news-2 score \<7), * unable to take oral medication, * immunocompromised, * creatinine clearance (ccl) \< 30 ml/min, * aspartate transaminase (ast) or alanine transaminase (alt) \> 5 times upper limit of normal (uln), * d-dimer \> 2microgram per liter, or * known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, copd, cerebrovascular disorder, malignancy of any type, pregnancy, * bmi less than 18 * smoking history (one pack per day) for past six months

Keywords: covid 19 treatment
south american thoracic stent-graft study

Conditions: Thoracic Aortic Aneurysm

Summary: a prospective, non-randomized multi-center clinical evaluation of the performance of the trivascular thoracic stent graft system when used in the treatment of subjects with thoracic aortic aneurysms (taa).


Eligibility criteria:
inclusion criteria: * the trivascular thoracic stent graft system is indicated in subjects diagnosed with an aneurysm in the descending thoracic aorta having vascular morphology suitable for endovascular repair, including: * adequate iliac/femoral access compatible with the required delivery systems, * non-aneurysmal aortic segments proximal and distal to the aneurysm.

Keywords: thoracic aortic aneurysm taa
metformin vs metformin combined with glp-1ra (glucagon-like peptide 1 receptor agonist) on overweight/obese pcos patients

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study was to determine whether metformin combined with exenatide once weekly (eqw) is more effective than metformin alone in the treatment of overweight/obese women with polycystic ovary syndrome (pcos). background therapies were diane-35 or/and progesterone capsule. 80 participants were randomized to use either metformin or metformin+eqw for 12 weeks. greater changes in body weight were anticipated in patients treated with eqw+metformin than metformin alone in those treated with metformin.


Eligibility criteria:
inclusion criteria: * females 18 years to 40 years of age * diagnosed as pcos by the 2003 rotterdam criteria. * overweight/obesity (bmi≥25 kg/m2) * no pregnant plan in recent 6 months * written consent for participation in the study exclusion criteria: * type 1 or type 2 diabetes mellitus * subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, cushing's syndrome, thyroid diseases, and hyperprolactinemia * diagnosed with or have a family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2) * serious systemic disease or malignant tumor * history of pancreatitis (chronic, acute or recurrent) * body weight change ≥10% at 3 months before treatment * used oral contraceptives or sex hormone drugs in the past 1 month * used oral glucocorticoids in the past 1 month * substance (alcohol or drug) abuse or dependence within 3 months; heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d) * subjects have a severe systemic disease, such as cardiovascular system * renal impairment, egfr\<60ml/min/1.73m2 * increase of transaminases up to \< 2.5 times of upper limit of normal value * have a history of thromboembolic disease or thrombotic tendency * subjects in pregnant or lactating or within 1 year after delivery. * subjects have an allergic history to the drugs used in the study * subjects have participated in other clinical researches of medicine within 1 month prior to randomization. * use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or otc) within 30 days before screening.

Keywords: pcos glp-1 glp-1ra exenatide metformin glucagon-like peptide 1 glucagon-like peptide 1 receptor agonist
amic compared with microfracture for focal articular cartilage damage of the hip

Conditions: Hip Arthroscopy; Articular Cartilage Defect; Microfractures

Summary: this is a pilot multi-centre rct of 40 patients (ages 18-55 years, inclusive) undergoing primary hip arthroscopy with a focal articular cartilage defect of the acetabulum to compare the effect of using autologous matrix-induced chondrogenesis (amic) in comparison to microfracture on hip function, health-related quality of life, hip pain, cartilage regeneration, health utility, and any adverse events at 2 years. follow-up will occur at 6 weeks, 6 months, 12 months, 18 months, and 24 months post-surgery.


Eligibility criteria:
inclusion criteria: 1. all patients aged 18-55 years 2. hip pain lasting 6 months or more with no relief from documented non-operative modalities 3. focal articular cartilage defects of the acetabulum on mri, confirmed to be full thickness (international cartilage regeneration and joint preservation society (icrs) grade 3 or 4) during arthroscopic examination 4. focal acetabular articular cartilage lesions measuring between 3 cm2 and 25 cm2 on mri and confirmed on arthroscopic examination 5. patient agrees to participate in the study-specific postoperative rehabilitation protocol 6. patient can speak, read, and understand the language of the site 7. patient has provided informed consent exclusion criteria: 1. cartilage defects of the femoral head 2. previous surgery on the study hip 3. traumatic chondral injury of the hip from a single event 4. presence of advanced osteoarthritis (tonnis grade 3) or any other acute or chronic inflammatory joint disease 5. known hypersensitivity or allergy to porcine collagen 6. acute or chronic infection at the surgical site 7. evidence of hip dysplasia (i.e., lateral centre edge angle \< 20˚) 8. evidence of acetabular over coverage such as coxa profunda or coxa protrusion 9. immunosuppressive or anti-proliferative medication use 10. chronic pain syndromes 11. significant medical co-morbidities (requiring assistance for activities of daily living (adls)) 12. history of paediatric hip disease 13. uncontrolled diabetes 14. contraindications to mri imaging (e.g. claustrophobia) 15. patient is involved in ongoing legal or workplace claims 16. patient is incarcerated 17. patient is pregnant or breastfeeding 18. patient who will likely have problems, in the judgement of the investigator, with maintaining follow-up 19. any other reason(s) the investigator feels is relevant for excluding the patient
cognitive behavioral therapy for insomnia (cbti) in patients with somatic disease

Conditions: Insomnia; Insomnia Chronic; Sleep Initiation and Maintenance Disorders; Sleep Disorder; Sleep Disturbance; Chronic Disease; Insomnia Due to Medical Condition; Insomnia, Psychophysiological

Summary: insomnia is common with co-morbid somatic disease, e.g. rheumatic disease, cancer, heart and lung disease or gastrointestinal disorders. pain, breathing difficulties and other symptoms of disease can worsen sleep problems and cause insomnia. in turn, insomnia may aggravate pain, fatigue and reduce quality of life in patients with somatic disorders. this project aims to evaluate a course offered to patients with insomnia and somatic disease at diakonhjemmet hospital. the course is based on cognitive behavioral therapy, a documented treatment for insomnia.


Eligibility criteria:
inclusion criteria: * men and women over 18 years with insomnia and co-morbid somatic disease. exclusion criteria: * unable to provide informed consent * unable to read and/or understand norwegian * unable to complete a survey * severe mental disorder, e.g. schizophrenia and bipolar disorder * mental retardation or dementia * known substance abuse * sleep disorders, e.g. narcolepsy or hypersomnia

Keywords: insomnia insomnia and co-morbid somatic disease cognitive behavioral therapy for insomnia cbti
prospective data collection of patients < 6 months of age undergoing thoracoscopic surgery

Conditions: Congenital Diaphragmatic Hernia; Tracheoesophageal Fistula; Esophageal Atresia

Summary: the study is primarily a descriptive study examining the physiological, ventilatory, surgical, and recovery effects of patients ≤ 6 months of age who undergo thoracoscopic surgery and to determine the accuracy of transcutaneous co2 (tc-co2) and end-tidal co2 (et-co2) during high frequency oscillatory ventilation (hfov) and thoracoscopic procedures.


Eligibility criteria:
inclusion criteria: * patients presenting for thoracoscopic surgery * patients aged ≤ 6 months of age exclusion criteria: * patients presenting for any procedure other than thoracoscopic surgery * patients aged \> 6 months of age
dermai to evaluate human factor of testing

Conditions: Contact Dermatitis

Summary: the purpose of this research is to improve how well remote patch allergy testing works and make sure they are easy and practical for people to use from home.


Eligibility criteria:
inclusion criteria: - willing and able to provide informed consent. exclusion criteria: * has used topical or oral steroids two weeks prior to patch testing. * currently taking immunosuppression agents or is immunocompromised due to medical condition. * no sunburn or rash at site of testing. * women who are breastfeeding or pregnant. * treatment with ultraviolet (uv) light (including tanning) during the two weeks prior to visit. * subjects unable to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting patch test area from excess moisture due to showering).
follow-up care after treatment for endometrial cancer

Conditions: Endometrial Neoplasm

Summary: the purposes of this study are to examine the needs (symptoms, support, information) and satisfaction of women during follow-up in the community after completing treatment for endometrial cancer. this information will be collected from the perspective of the women themselves, their primary care providers (family physician or gynecologist) and the health care providers (oncologist, nurses, social worker, psychologist) at the cancer centre.

research question how has this transfer in follow-up care impacted performance indicators? * volume of follow-up care transferred * percentage of women, who have required a re-entry consultation * fiscal implication of this transfer of follow-up care patient stakeholders: * what are women's perceptions of the transition of follow-up care? * what are women's supportive care needs during the transition of follow-up care and ongoing needs? primary care practitioner stakeholders: * what are the primary care practitioners' perceptions of the process of transition of follow-up care? * what are the primary care practitioners' educational needs? * what are the primary care practitioners' perceptions of the process of re-entry for in women with suspected recurrence? tertiary centre: health care providers stakeholders o what are the perceptions of tertiary health care providers about the transition of follow-up care?

Eligibility criteria:
inclusion criteria: * participants- women diagnosed with endometrial cancer: * 18 years of age or older. * speak english or french * who have been treated (surgery and/or radiation therapy) at toh. * who have been discharged from follow-up in the cancer centre in the past 6 months. * participants-primary care provider practitioner: * providing follow-up care to at least one woman with endometrial cancer * participants- health care providers at the tertiary centre : * physicians, nurses or allied health care providers whose primary responsibility are to provide care to women with gynecological cancer. exclusion criteria:

Keywords: endometrial neoplasia follow-up care survivorship primary care provider
efficacy and safety comparing 5% monoxidil milky lotion versus 5% minoxidil solution in androgenetic alopecia

Conditions: Objective (Goal); Self-Assessment; Adverse Effects

Summary: 5% minoxidil lotion was approved for using to stimulate hair growth in male androgenetic alopecia by us fda science 1988. the mechanism of action still unclear. in general the 5% minoxidil in solution is the first choice preparation for treatment, therefore allergic contact dermatitis to solution was report up to 5.7% (ebner h. et al,1995). propylene glycol which is the main solvent of these solution, was the main responsible to allergic contact dermatitis with positive patch test up to 81.8% (friedman es. et al. 2002) one of the alternative solution using butylene glycol as the solvent was invented to solve the problem. in siriraj hospital the investigators using this new solvent and made our in house product called 5% minoxidil milky lotion. however the efficacy and safety of the new solution have not been investigated. this study is conducted to evaluated efficacy and safety of 5% minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.

the 5% minoxidil in solution is the first choice preparation for treatment for androgenetic alopecia (aga), 5% minoxidil milky lotion is the alternative solution using butylene glycol as the solvent to solve allergic contact dermatitis problem. in siriraj hospital the investigators using this new solvent and made our in house product called he efficacy and safety of the new solution have not been investigated. this study is conducted to evaluated efficacy and safety of 5% minoxidil milky lotion compare with the classic solution in male androgenetic alopecia.

Eligibility criteria:
inclusion criteria: * new case male aga * classification norwood iii vertex or iv exclusion criteria: * have previous aga treatment in 6 month prior * complicated case with other disease condition effect hair such as anemia, dm, chronic alcoholism, autoimmune disease, thyroid disease, previous gi surgery etc. * other scalp lesion such as psoriasis, tinea capsitis * psychological disorder including trichotillomania
a phase 1b study of axitinib in combination with crizotinib in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: despite the success of anti-angiogenic therapy in multiple treatment settings, a fraction of patients are refractory to vascular endothelial growth factor (vegf) inhibitor treatment, while the majority of patients will eventually develop evasive resistance. it is proposed that mesenchymal-epithelial transition factor (c-met) and its ligand hepatocyte growth factor (hgf or scatter factor) contribute to vegf inhibitor resistance, such that combining a c-met inhibitor with a vegf inhibitor will provide additional clinical activity compared to vegf inhibitor alone. this hypothesis will be tested using the cmet/alk inhibitor, crizotinib, in combination with the vegf inhibitor, axitinib.since this will be the first study of axitinib given in combination with crizotinib, the study will primarily assess the safety and tolerability of the combination regimen.


Eligibility criteria:
inclusion criteria: * diagnosis - dose escalation phase: histologically or cytologically confirmed diagnosis of advanced solid tumor that is resistant to standard therapy or for which no standard therapy is available. * diagnosis - dose expansion phase: histologically or cytologically confirmed advanced rcc with a component of clear cell subtype * dose expansion phase: at least one measureable lesion as defined by recist \[response evaluation criterion in solid tumors\] version 1.1. * ecog \[eastern cooperative oncology group\] performance status 0 or 1. exclusion criteria: * major surgery \<4 weeks or radiation therapy \<2 weeks of patient registration. * history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease. * dose expansion phase only: diagnosis of any other malignancy within 2 years prior to registration.

Keywords: carcinoma renal cell