Kornimate/medical-research-clean huggingface dataset:
home-based assessment of pro measures in scd using a smartphone app platform: a feasibility study

Conditions: Sickle Cell Disease; Sickle Cell Hemoglobin C; Sickle Beta Zero Thalassemia; Sickle B+ Thalassemia

Summary: the overarching goal of this proposal is to identify modifiable behavioral strategies based on patient-reported outcomes (pros) and health-related quality of life (hrqol) that will improve hydroxyurea (hu) adherence among adolescents and young adults with sickle cell disease (scd). in this proposed study, we intend to test the functionality of a pros-toolbox feature, which will be integrated into our existing smartphone application platform (scd-app), over a 24-week period in a cohort of scd patients and their caregivers.

adherence to hydroxyurea is a multi-factorial dynamic process, and, to date, predictors for changes in adherence levels over time remain unclear. changes in hrqol data could serve as surrogate markers for changes in hydroxyurea adherence over time, and could suggest when patients might or might not need or benefit from an intervention based on worse or better hrqol scores, respectively. the main hypothesis of this study is that the assessment of patients' hrqol at home using a scd smartphone application platform (app) is feasible and acceptable, and that less frequent assessments of hrqol at home will have an overall higher completion rate when compared to more frequent ones. we plan to assess hrqol using the nih-developed patient reported outcomes measurement information system (promis®) with computerized adaptive testing (cat) approach. promis®-cat approach is a reliable and valid pros assessment platform that has been used in limited studies in scd. the study will include the following specific aims: 1. to evaluate the feasibility and acceptability of the assessment of patients hrqol at home using smartphones with promis®-cat measures integrated into a scd-app. 2. to examine the effect of the frequency of required hrqol assessments on participants' completion rate over 24-week period with hrqol evaluated every 2 weeks (group 1) versus every 4 weeks (group 2). 3. to explore participants' experience and preferences with the process and the frequency of hrqol assessment at home using their smartphones with promis®-cat measures integrated into a scd-app.

Eligibility criteria:
inclusion criteria: * age 12 years or older at the time of study enrollment; * scd diagnosis (all genotypes) confirmed by hemoglobin electrophoresis; * own or have access to a smartphone or a tablet; and * speak and read english. exclusion criteria: * patients or caregivers with cognitive impairment; * patients or caregivers physical impairment; and * patients or caregivers who will not be able to complete study assessments.
study of morphological, spectral and metabolic manifestations of neurological complications in covid-19 patients

Conditions: Covid19; Neurological Manifestations; Brain Damage

Summary: viral pandemics, such as hiv and sars-cov-v1, have shown that they can lead to acute and / or delayed neurological complications. at the actual context of the pandemic coronavirus disease 2019 (covid-19), neurological manifestations seem to be confirmed since in 85% of covid-19 patients, present neurological symptoms, including anosmia, ageusia, periorbital pain, dizziness, fatigue, even moderate headache, moderate memory and/or behavioral disorders. however, these neurological manifestations are not well studied and their radiological features are not well described. it is therefore important to assess these potential neurological complications in covid-19 patients. to the investigator knowledge, there is no previous study in the literature describing spectral brain changes in covid + patients. thus, the goal of this work is to describe the radiological semiology using mri and particularly magnetic resonance spectroscopic (mrs) biomarkers in the evaluation of acute and / or delayed brain damage in covid + patients presenting a neurological manifestations that are initially related to the cranial nerves damage.


Eligibility criteria:
inclusion criteria: * major covid-19 patient (≥18 years old) * covid-19 patient presenting at least one the neurological manifestations: anosmia, ageusia, periorbital pain, dizziness, fatigue, moderate headache, moderate memory and behavioral disorders. * patient who have signed an informed consent form for the study exclusion criteria: * patient under guardianship or curators or under judicial protection * pregnant and breastfeeding women

Keywords: covid19 neurological manifestations mri and nmr spectroscopy radiological semiology spectral profile brain damage
linagliptin 2.5 mg twice daily versus 5 mg once daily as add-on therapy to twice daily metformin in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. it is planned to show non-inferiority of linagliptin 2.5 mg twice daily compared to 5 mg once daily and each treatment's superiority over placebo.


Eligibility criteria:
inclusion criteria 1. diagnosis of type 2 diabetes mellitus. 2. current treatment with metformin alone (\>/= 1500 mg or maximally tolerated dose) or metformin plus 1 other antidiabetic drug. metformin must be administered in twice daily dosing regimen. patients taking metformin three times daily can be included if posology is switched to twice daily and total daily dose is maintained. 3. glycosylated haemoglobin (hba1c) is between 7.0% - 10.0%. 4. body mass index (bmi) \</=45 kg/m2. exclusion criteria 1. treatment with extended release metformin. 2. uncontrolled hyperglycaemia (fasting plasma glucose \> 240 mg/dl or 13.3 mmol/l). 3. myocardial infarction (mi), stroke or transient ischaemic attack (tia) within 6 months prior to informed consent. 4. impaired hepatic or renal function, or gastric bypass surgery. 5. treatment with glitazones, glucagon like peptide-1 (glp-1) analogues/mimetics, antiobesity agents, or insulin within 3 months of informed consent. 6. current treatment with systemic steroids or change in dosage of thyroid hormones. 7. alcohol or drug abuse within 3 months of informed consent. 8. participation in another trial with investigational drug within 2 months prior to informed consent. 9. pre-menopausal women who are nursing, pregnant or not practicing an acceptable method of birth control.
prevalence of familial hypobetalipoproteinemia in psychiatric population (partition)

Conditions: Familial Hypobetalipoproteinemia

Summary: the links between low ldl-c levels and psychologic symptoms (psychotic disorders, mood disorders, aggressivity, suicidal risk, etc.) and cognitive deficits (mainly executing functioning) are debated. the partition study aims at estimating the prevalence of hypobetalipoproteinemia (hbl), defined as a ldl-c level ≤ 0,50 g/l, in a psychiatric population.

some forms of hypobetalipoproteinemia (hbl) are associated with a longevity syndrome and cardiovascular protection due to prolonged exposure to low levels of ldl-c. however, while ldl-c reduction has been studied extensively for its beneficial effect on cardiovascular risk, other studies have reported that low levels of ldl-c (either spontaneous or artificially occurring with low-fat diets or lipid-lowering drugs) may be associated with psychiatric symptoms (psychotic or mood disorders, aggression, suicidal attempts, etc.) or altered cognitive performance (particularly executive functioning). these studies have led to contradictory results, and the possible link between low ldl-c levels and psychiatric symptoms remains highly controversial so far. the partition study aims at estimating the prevalence of hypobetalipoproteinemia (hbl), defined as a ldl-c level ≤ 0,50 g/l, in a psychiatric population. moreover, the study includes the characterization of psychiatric disorders as well as psychological and personal characteristics associated with hbl. the evolutionary profile of patients with and without hbl will be studied. genetic characteristics and biomarkers of hbl will also be studied.

Eligibility criteria:
inclusion criteria: all patients hospitalized in one of the full-time adult psychiatric departments of nantes university hospital may be included, without maximum age limit. minors and patients under guardianship and tutorship may be included, taking into account the study population and the low risks and constraints of the study exclusion criteria: * minors under 15 years * pregnant or nursing woman; * simultaneous participation in another interventional research on a drug; * not mastering the reading and writing of the french language well enough

Keywords: psychiatry, hypobetalipoproteinemia, ldl-cholesterol
an expanded access program to axitinib is available for patients with advanced forms of kidney cancer (ductal; papillary; chromophobic; oncocytic) with mutations in vhl, pbrm1 / bap1, setd2, vegf)

Conditions: Clear Cell Kidney Cancer; Kidney Cancer; Kidney Cancer With PBRM1/BAP1/VHL/SETD2 Mutations

Summary: kidney cancer belongs to a heterogeneous group of tumors and is the most common oncourological disease; up to 80% of cases are clear cell carcinoma.

the study of rare hereditary forms of clear cell kidney cancer (crp) made it possible to identify the vhl gene, germline mutations which lead to the development of the hippel-lindau syndrome, and somatic mutations are characteristic of sporadic crp. the second most frequent mutation independent of vhlmut is the pbrm1 gene involved in chromatin remodeling. pbrm1 mutations are positively correlated with setd2 mutations and negatively correlated with bap1 mutations. depending on the status of pbrm1/bap1 mutations, tumors are characterized by different pathomorphological features and prognoses. the main stages of the clonal evolution of srp, which is already at the early stages and is characterized by pronounced intratumoral genetic heterogeneity, have been determined. however, as prp progresses, subclones acquire different secondary mutations that contribute to the activation of the same mtor and vegf signaling pathways, as well as disrupting the mechanisms of chromatin remodeling and the functioning of tp53. the present program will determine the efficacy of standard doses of axitinib in patients with differentiated mutations in kidney cancer following partial exome sequencing.

Eligibility criteria:
inclusion criteria: * histologically documented metastatic renal cell cancer or cell kidney cancer * evidence of measurable disease. * adequate renal function (serum creatinine level) * ecog status 0-1 * patient must provide signed informed consent * male or female, age \>/= 18 years exclusion criteria: * current use or anticipated need for treatment with drugs that are known potent cyp3a4 inhibitors * current use or anticipated need for treatment with drugs that are known as potent cyp3a4 or cyp1a2. * active gastrointestinal bleeding. * severe allergic reactions * unwillingness or inability to comply with mandated pretreatment biopsy or therapeutic regimen
treatment of gingival recession defects using platelet-rich fibrin with an allogenic dermal matrix

Conditions: Gingival Recession

Summary: the study aims to test the non-inferiority of an allogenic dermal matrix with platelet-rich fibrin for treatment of gingival recessions in comparison to the connective tissue graft.

currently the connective tissue graft (ctg) is referred to as the gold standard in terms of the grafting material for the treatment of gingival recession defects. this study test the non-inferiority of the allogenic dermal matrix (adm) with platelet-rich fibrin (prf) to that of the ctg, in terms of the amount of root coverage obtained after the procedure.

Eligibility criteria:
inclusion criteria: * periodontally and systemically healthy adults * full-mouth plaque score and full-mouth bleeding score ≤ 20% * presence of at least one 3 mm or deeper gingival recession, with at least 1.5 mm of keratinized tissue, and 1 mm of gingival thickness) requiring surgical intervention for root coverage * no interproximal attachment/bone loss * no prior experience of root coverage procedures within the last 1 year * the patient must be able to perform good oral hygiene exclusion criteria: * contraindications for undergoing periodontal surgery * teeth with more than grade ii mobility, or furcation involvement of class iii * patients pregnant or attempting to get pregnant (self-reported), or nursing women * untreated/active periodontitis, or other untreated acute infections at the surgical site * untreated malignancies at the surgical site * persistence of uncorrected gingival trauma from traumatic toothbrushing * presence of severe tooth malposition, rotation or clinically significant super-eruption * self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking, or active tobacco chewing, or chronic vaping * patients with any known history of blood disorders or complications such as abnormal concentration of thrombin and factor xiii in plasma, or hemophilia * patients with significant co-morbidities, such as obesity, uncontrolled diabetes, immunosuppression, severe endocrine-induced bone diseases, signs of malnourishment, those receiving immunosuppressive therapy, poor tissue oxygenation or perfusion, and pre- or post-operative radiation * patients with known sensitivity to polysorbate 20, cefoxitin, lincomycin, polymyxin b, vancomycin
study of talaporfin sodium photodynamic therapy to treat advanced age related macular disease

Conditions: Macular Degeneration; Choroidal Neovascularization

Summary: the purpose of this study is to determine the safety and tolerability of talaporfin sodium (ls11) photodynamic therapy in patients with late stage age-related macular disease (amd).

this phase 1 study is a safety and tolerability investigation of ls11 photodynamic therapy in subjects with persistent leaking neovascular membranes in patients with amd who have a visual acuity of 20/200 or less. this is a sequential group dose escalation trial with the cohorts defined by increasing the light dose. within each light-dose cohort, three (3) subjects will be treated at a drug dose of 0.2 mg/kg or 0.5 mg/kg.

Eligibility criteria:
inclusion criteria: * age 50 or older * subject is able to sign informed consent * ability to complete 6 month trial * present with advanced amd and persistently leaking cnv * adequate hematologic, renal and liver function * negative pregnancy test * subject is able to safely undertake all protocol directed instructions * visual acuity of 20/200 (logmar 1.0)(6/60) or worse exclusion criteria: * concomitant eye disease in eye to be treated * prior ocular radionuclide treatments * known allergic or hypersensitivity reactions to light and/or fluorescein and iodine or shellfish * history of investigational drug or therapy including biologics within 30 days prior to the study drug dosing * women who are pregnant or lactating, or women of childbearing years not taking adequate contraception precautions * history of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum * history of clinically significant cardiovascular abnormalities, including myocardial infarction in the past 6 months, uncontrolled arrhythmias, uncontrolled congestive heart failure * concomitant use of other drugs known to produce skin photosensitivity, e.g. tetracycline, sulfonamides, phenothiazines, sulfonylureas, thiazide diuretics and griseofulvin, st. john's wort * subjects with high or pathological myopia with an axial length \> 26mm or a refractive error of \>/= -8.00d * subjects with glaucoma and vision loss in either eye * subject with a history of other choroidal leakage, e.g. histoplasmosis * subjects with significant media opacity * subjects diagnosed with diabetic retinopathy * subjects who have had eye surgery within the past 3 months * subjects who have received pdt treatment for amd in the treatment eye * any disease or condition that the sponsor or the investigator believes will impact the subject's ability to adhere to the study schedule * subjects participating in any concurrent trial

Keywords: macular disease wet amd amd age-related macular disease pdt photodynamic therapy
getting back on track: an educational group for women with breast cancer

Conditions: Breast Cancer

Summary: as the number of women who survive breast cancer continues to grow, more attention is being paid to their quality of life and the disease's long-term effects. the transition from patient to survivor, also termed the "re-entry transition", can be a very difficult and stressful time. a brief psychosocial intervention delivered at this important transition time may address the challenges that women face at re-entry, facilitating greater adaptation and more optimal recovery. the purpose of the proposed rct is to test the acceptability and effectiveness of a single-session group psychoeducational intervention led by a multi-disciplinary team on adjustment to survivorship. a randomized controlled trial design (rct) will be used to recruit 440 women attending the breast clinic at princess margaret hospital in toronto. participants will be recruited while completing their adjuvant radiotherapy and those who agree to participate will complete the baseline questionnaire package (t0). they then will be randomized to receive either: (1) standard print material (crl group n=220); or (2) standard print material and a single session group psychoeducational intervention (int group n=220). two weeks following randomization, participants in the crl group will be given the "getting back on track: life after treatment" booklet (current standard care), which includes information on the new health care team, physical side-effects, diet and exercise, emotional and social needs and returning to everyday life. participants in the int group will receive the same booklet and will also attend a 2- hour psychoeducational group session facilitated by a multidisciplinary team. participants in both groups will be asked to complete the questionnaire package again at 3 months (post-1) and 6 -months (post-2) following the completion of cancer treatment. participants in the inv group will also be asked to rate their satisfaction with the class and provide feedback on the content. the proposed intervention will be one of the few clinical interventions designed to address the service gap in helping women to make the transition from patients to survivors by using a single-session psychoeducational group intervention.


Eligibility criteria:
inclusion criteria: * outpatients attending treatments at pmh * have a diagnosis of breast cancer; * have undergone initial treatment for breast cancer; * are receiving adjuvant radiation therapy as last hospital-based component of treatment; * are able to speak, read and write english. exclusion criteria: * metastatic disease * local recurrence * cognitive impairment * if they are an inpatient

Keywords: single-session group psychoeducational intervention
phase 3 evaluation of efficacy and safety of ar882 in gout patients (ar882-301)

Conditions: Gout; Arthritis, Gouty; Hyperuricemia; Gout Chronic

Summary: this study will assess the serum uric acid lowering effect and safety of ar882 in gout patients at two doses compared to placebo over 12 months


Eligibility criteria:
inclusion criteria: * history of gout * occurrence of ≥ 2 self-reported gout flares in the last 12 months * body weight no less than 50 kg * patients who are not on approved urate-lowering therapy (ult) must have sua ≥ 7 mg/dl * patients who are on medically appropriate ult must have sua \> 6 mg/dl * serum creatinine must be \< 3.0 mg/dl and estimated clcr ≥ 30 ml/min exclusion criteria: * malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * pregnant or breastfeeding * history of symptomatic kidney stones within the past 6 months
hemodynamic monitoring in liver transplant with venart cardiac output versus swan-ganz catheter (vero study)

Conditions: Cardiac Output, Low; Liver Transplant; Complications

Summary: the swan-ganz catheter is the gold standard to measure cardiac output during liver transplantation surgery. this is an invasive hemodynamic monitoring system. the venart cardiac output (mespere lifesciences, waterloo, canada) is a new, innovative and non-invasive device that permits hemodynamic monitoring. with a software based on fick's principle it is able to calculate cardiac output, cardiac index and continuous cardiac output. the hypothesis of this study is to investigate the precision and accuracy of this method versus the standard of care during liver transplantation.


Eligibility criteria:
inclusion criteria: * liver transplantation patients exclusion criteria: * age \< 18 years old * combined liver-kidney transplant * liver transplant for acute insufficiency * no consent of the patient
diuresis, functional bladder capacity and luts in ckd and esrd patients.

Conditions: Lower Urinary Tract Symptoms; End Stage Renal Disease

Summary: the aim of the study is to evaluate the prevalence of luts in patients with moderate to severe (stage iiib), severe (stage iv) ckd and esrd : stage v ckd) without renal transplantation (both pre-dialysis and dialysis patients). the study will also investigate the correlation between the diuresis, functional bladder capacity and luts in this population. by means of the obtained results, the investigators hope to be able to predict at which values of diuresis and functional bladder capacity these patients will start to develop luts. the investigators will also evaluate the impact of luts on the quality of life of these patients.

pre-dialysis and peritoneal dialysis (home dialysis) and hemodialysis patients will be asked to fill in a 24h voiding diary the day prior to the control visit or dialysis session, or this can be registered the day of planned 24h urine collection. all patients will be asked to fill a iciq-luts questionnaire. the iciq-luts questionnaire is a validated questionnaire to investigate the presence of luts in a non-invasive way: iciq-fluts(female lower urinary tract symptoms) for female patients and iciq-mluts(male lower urinary tract symptoms) for male patients. following patient data will be registered: * age * gender * egfr(estimated glomerular filtration rate) (ckd-epd) * cause of ckd-esrd * in case of dialysis: duration modality (hemodialysis or peritoneal dialysis) * antecedents * comorbidities * medication * 24h voiding diary * luts questionnaire

Eligibility criteria:
inclusion criteria: * \>18years old * gfr(ckd-epi) \< 45 ml/min and persisting minimal diuresis * able to read and understand dutch, french or english exclusion criteria: * \<18 years old * egfr (ckd-epi) \> 45 ml/min * egfr (ckd-epi) \ 3 months absent persisting minimal diuresis * unable to read and understand dutch, french or english * renal transplant recipients.

Keywords: lower urinary tract symptoms end stage renal disease
endoplasmic reticulum stress in chronic respiratory diseases

Conditions: ER Stress,; Chronic Airway Disorders,; Lung Cancer,; Interstitial Lung Diseases

Summary: aim: to investigate whether er stress is implicated in the pathogenesis of various pulmonary disorders measurement: 1. unfolded protein responses (uprs) in blood (pbmcs)of patients 1. chop 2. grp 78 and so on 2. unfolded protein responses (uprs) in blood (pbmcs)of healthy controls 1. chop 2. grp 78 and so on


Eligibility criteria:
inclusion criteria: * \> 18 yrs * definitive diagnosis as chronic pulmonary diseases by physician exclusion criteria: * any other chronic medical illness such as dm, htn, and other malignancy