Kornimate/medical-research-clean huggingface dataset:
national exhaustive cohort of hereditary stomatocytoses and other channelopathies affecting the red blood cell

Conditions: Stomatocytosis

Summary: hereditary stomatocytosis is a heterogeneous group of rare constitutional diseases of dominant transmission in the vast majority of cases. the data concerning their clinical and biological presentation, and their evolution are few, and come from about thirty clinical cases. the constitution of an exhaustive french cohort of hereditary stomatocytosis will improve the establishment of the diagnosis and the management of patients

the patient is prospectively included. the referring hematologist will inform the patient about participation in the cohort, give him the information note and obtain his non-objection agreement to the use of his data for research purposes. the data will be collected from the medical file of each patient as part of his usual annual follow-up.

Eligibility criteria:
inclusion criteria: * any patient with a diagnosis of stomatocytosis without age limit * patient affiliated or beneficiary of french social security * no objection from the patient or legal representative exclusion criteria: * diagnosis of stomatocytosis excluded by ektacytometry and / or genetics * patient under guardianship, with curators or legal protection

Keywords: rare genetic disease
a study of cs1001 in subjects with relapsed or refractory extranodal natural killer/ t cell lymphoma(enktl)

Conditions: Extranodal Natural Killer/T-Cell Lymphoma

Summary: this is a multicenter, single-arm, phase ii study to evaluate the efficacy and safety of cs1001 monotherapy for relapsed or refractory extranodal natural killer/ t cell lymphoma (enktl)

eligible subjects with rr-nktl after prior asparaginase-based chemotherapy or chemo radiotherapy are planned to receive cs1001 1200 mg intravenous infusion every three weeks until progression of disease, intolerable toxicity, consent withdrawn, death. the primary endpoint of this trial is objective response rate (orr), as assessed by independent radiological review committee (irrc) based on criteria for response assessment of lymphoma: lugano 2014 classification.

Eligibility criteria:
inclusion criteria: 1. subject must have a histologically confirmed nktl at study site. 2. subject must have relapsed or refractory nktl after prior asparaginase-based chemotherapy or chemo radiotherapy. 3. eastern cooperative oncology group performance status (ecog ps) of 0 or 1. 4. subject must have at least one evaluable or measurable lesion per lugano 2014 classification. 5. subject must have adequate organ function and bone marrow function without severe hematopoietic disorder, or heart, lung, liver or kidney dysfunction or immune deficiency. 6. subject must provide stained tumor tissue sections and corresponding pathological report or unstained tumor tissue sections (or tissue block) for central pathology review. 7. subject with prior anti-cancer treatment can only be enrolled when the toxicity of prior anti-cancer treatment has recovered to baseline or ≤ grade 1 according to common terminology criteria for adverse events (ctcae) v4.03. exclusion criteria: 1. invasive natural killer leukemia. 2. concomitant with hemophagocytic syndrome. 3. primary site in central nervous system (cns) or cns involvement. 4. subjects currently participating in other clinical studies or use of any investigational drug within 4 weeks prior to the first dose of cs1001. 5. subjects who received systemic corticosteroid or any other immunosuppressive therapy within 14 days prior to the first dose of cs1001. 6. subjects who had prior chemotherapy, immune therapy, biological therapy as systemic treatment for cancer, within 28 days prior to the first dose of cs1001. 7. receipt of traditional medicinal herbal preparations with anti-tumor indications with 7 days prior to the first dose of cs1001. 8. known history of human immunodeficiency virus (hiv) infection and/or acquired immune deficiency syndrome. 9. subjects with active hepatitis b or c infection. 10. subjects with active tuberculosis infection. 11. subjects who received prior therapy with anti-pd-1, anti-pd-l1 or anti-ctla-4 monoclonal antibody. 12. female subjects who are pregnant or breast-feeding. for more information regarding trial participation, please contact at cstonera@cstonepharma.com

Keywords: enktl
177lu-pp-f11n in combination with sacubitril for receptor targeted therapy and imaging of metastatic thyroid cancer

Conditions: Thyroid Cancer, Medullary

Summary: the purpose of this study is to determine the use of 177lu-pp-f11n for imaging and therapy of patients with advanced medullary thyroid carcinoma (mtc). 177lu-pp-f11n is a gastrin analogon, binding to cholecystokinin-2 receptors. this receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

a phase 0 study (lumed study part a) was already performed, showing low toxicity of 177lu-pp-f11n and tumor uptake in all patients. co-injection of physiogel (gelofusin) showed insignificant reduction of kidney uptake and can therefore be omitted for a radionuclide therapy with 177lu-pp-f11n. in this study, the effect of the nep-1 inhibitor sacuitril on the in-vivo stability of 177lu-pp-f11n and the uptake, respectively radiation doses in mtc metastases and organs will be evaluated, using a cross-over design already used for the lumed part a study. each patient will receive two injections of 177lu-pp-f11n, with and without additional medication with sacuitril imaging findings, acquired by spect/ct, will be compared to imaging with 68ga-dotatoc positron emission tomography (pet)/ct. the inclusion of 8 patients is planned.

Eligibility criteria:
inclusion criteria: * advanced mtc with elevated levels of calcitonin (\> 100 pg/ml) and/or calcitonin-doubling time \< 24 months before or after total thyroidectomy * 68ga-dotatoc pet/ct not older than 12 weeks * age \> 18 years * informed consent exclusion criteria: * medication with vandetanib 3 weeks before the study and during the study * renal failure (calculated glomerular filtration rate (gfr) \< 60 ml/min per 1.73 m2 body surface). * bone marrow failure (thrombocytes \< 70 000/μl, leucocytes \< 2 500/μl, hemoglobin \< 8 g/dl). * pregnancy and breast feeding * known, serious side reaction in the case of a former application of pentagastrin * active, second malignancy oder remission after second malignancy \< 5 years * age over 64 years * systolic bood pressure \< 112 mmhg at the time of screening * simultaneous medication with angiotensin converting enzyme (ace)-inhibitors, or withdrawal for less than 36 h prior to the medication with entresto or simultaneous medication with at-ii-receptor blockers * known intolerance to sacubitril or valsartan * known angioedema in anamnesis in the context of a medication with an ace-inhibitor or an at-ii-receptor blocker

Keywords: calcitonin medullary thyroid carcinoma peptide receptor radionuclide therapy gastrin cholecystokinin-2 receptor
usz bioresource covid-19

Conditions: COVID19

Summary: mono-centric. blood sampling for biobank development, including linkage to patient data (resource for research on covid19).


Eligibility criteria:
inclusion criteria: * m/f age \> 18 years * sars-cov-2 infektion (according to who guideline) * hospitalisation, general ward * acceptable language knowledge * voluntary ifc and biobank appendix exclusion criteria: * contra indication for blood sampling
the effect of a motor-cognitive rehabilitation on attention in parkinsonian patients

Conditions: Parkinson's Disease

Summary: in this study the investigators explore two questions: if the attentive reaction times differs in parkinsonian patients from health controls and if an intensive, focused and aerobic rehabilitation program (multidisciplinary intensive rehabilitation treatment - mirt) tailored mainly for motor problems, could have a specific positive effect on multiple choices reaction times (rts) as an indirect marker for an effect on attentional-executive frontal circuits. the hypothesis is that the mirt could have a positive effect on the top-down control mechanisms, since the continuous feedback given by physiotherapist during exercises and the use of cues and devices (such as treadmill plus and stabilometric platform), stimulate the selective attention processes that enable goal-directed, internally-driven decision, helping the patients to overcome externally-driven decision based on stimulus salience and novelty

objective: to evaluate the attentive performances in parkinsonians in comparison with healthy controls and the effect of motor-cognitive rehabilitation program on attention. methods: 103 parkinsonians (stage 2,5-3 h\&y) hospitalized for a 4-week multidisciplinary intensive rehabilitation treatment and 34 healthy controls were enrolled. all subjects underwent three different attentive tasks: visual reaction times, auditory reaction times and multiple choices reaction times tasks. to evaluate the effect of rehabilitation on attention, patients performed the same battery at discharge. to investigate the effects of mirt on motor functions and quality of life we also assessed updrs iii, timed up and go test and parkinson's disease questionnaire.

Eligibility criteria:
inclusion criteria: * stage 2.5-3 according to the hoehn \& yahr scale * pharmacological treatment for the last 8 weeks and during the hospitalization * mini mental state examination (mmse) ≥ 24 exclusion criteria: * any focal brain lesion detected in brain imaging studies (computed tomography or magnetic resonance imaging) performed in the previous twelve months * disabling drug-induced dyskinesias * disturbing resting and/or action tremor, corresponding to scores 2 to 4 in the specific items of unified parkinson's disease rating scale section 3 (updrs iii) * behavioral disturbances (evaluated with neuropsychiatric inventory) * visual and auditory dysfunctions according to the general clinical evaluation and medical history

Keywords: parkinson's disease rehabilitation attention executive functions
cryotherapy with or without short-term adjuvant androgen-deprivation therapy in prostate cancer

Conditions: Prostate Cancer

Summary: this is an open-label randomized clinical study comparing primary prostate cryoablation alone (no-adt group) with cryoablation plus short-term adjuvant androgen-deprivation therapy (adj-adt group) in the treatment of patients with high-risk localized prostate cancer.

subjects (n=182) who have high-risk prostate cancer and have undergone primary prostate cryotherapy will be screened and randomized in a 1:1 ratio to receive either adjuvant adt (adj-adt) or no-adt until disease progression. screening and randomization will be done within four weeks after cryoablation. only those who are assigned to adj-adt will receive adt for a total of 12 months. psa will be checked every 3 months in the first year after cryo and every 6 months thereafter. long-term follow-up parameters include serum psa and protocol-mandated biopsies (at 36 months after cryo, irrespective of psa levels if recurrence has not been documented). for-cause biopsy will also be done if post-cryo psa elevation reaches the phoenix criteria (nadir + 2 ng/ml) or when the treating physician thinks it necessary to document tumor recurrence.

Eligibility criteria:
inclusion criteria: 1. age\>20 years 2. histopathology proven prostate adenocarcinoma 3. non-metastatic localized disease 4. prostate cancer is deemed high-risk for recurrence(psa\>20 ng/ml, gleason score\>=8, or clinical staging\>=t2c) 5. subjects have undergone prostate cryoablation as the definitive treatment prior to enrolling the study 6. subjects who have not been treated with any definitive treatments for prostate cancer, including radical prostatectomy or definitive radiotherapy. however, those who have undergone focal prostate cryoablation and have cancer recurrence are still eligible. 7. subjects may or may not have received neoadjuvant androgen-deprivation therapy (adt) in the forms of either castration (medical) and/or antiandrogens. surgical castration (orchiectomy) is not allowed. 8. subjects are willing to sign the informed consent and agree to comply with the study procedures exclusion criteria: 1. those who have been treated with \> 8 weeks (collectively if not continuously) of neoadjuvant adt prior to screening. 2. subjects who have other cancer that is deemed not cured or are known less than 5 years except for basal cell carcinoma of the skin 3. other conditions the investigators think may affect subject compliance or safety

Keywords: localized high risk prostate cancer randomized cryotherapy cryoablation adjuvant androgen deprivation therapy hormone therapy adt
the effects of glucocorticoids on glucose metabolism in patients with interstitial lung disease

Conditions: Interstitial Lung Disease

Summary: this study is aimed at exploring the effects of glucocorticoids on glucose metabolism in patients with interstitial lung disease. patients with interstitial lung disease who is on the medication of 15mg prednisolone and 7.5mg prednisolone conduct the continuous glucose monitoring (cgm). the data attained from the cgm are used to define the glycemic characteristics in patients using glucocorticoids and the difference of glucose features due to different doses.

patients diagnosed of interstitial lung disease and treating with glucocorticoids could be enrolled in this clinical trial. those who is in an acute inflammatory phase and diagnosed with hemorrhagic disease should are excluded, so are those unwilling to carry the continuous glucose monitoring (cgm) device. when the dose of prednisolone is applied 15mg per day steadily and is going to be decreased, the cgm is conducted. at the same time, blood tests evaluating the glucose metabolism are measured, including hba1c, ga, fasting insulin and fasting glucose. after taking 7.5mg prednisolone per day for 3 months, participants do the cgm and blood tests again to evaluate the glucose metabolism during this period. the cgm data could be used for the glucose evaluation, which can manifest the glucose characteristics in the circumstances of glucocorticoid use. by comparing the cgm data and the blood tests, the investigators hope to find the different features of the glucose metabolism due to different doses.

Eligibility criteria:
inclusion criteria: * patients diagnosed with interstitial lung disease exclusion criteria: * patients who are in an acute inflammatory phase * patients who are diagnosed hemorrhagic disease * patients who are unwilling to carry the continuous glucose monitoring device

Keywords: interstitial lung disease glucocorticcoid glucose continuous glucose monitor
oral cancer screening in workplace: a cross-sectional study

Conditions: Oral Cancer

Summary: employees are to be all screened for oral cancer in work place.


Eligibility criteria:
inclusion criteria: * adults exclusion criteria: * refusal to participate
immune response to vaccination against covid-19, a follow up study

Conditions: Vaccination; Infection; Covid19

Summary: the study investigates the immune response after vaccination in individuals with and without pre-existing immunity to coronavirus disease (covid) -19. the participants are followed and sampled up to 4 years after vaccination. blood samples are collected at different timepoints to analyze immune response. the aim is to investigate the level of specific antibodies to severe acute respiratory syndrome coronavirus 2 (sars-cov-2) yearly, up to 4 years after vaccination.

the main objective is to investigate if the antibody development to sars-cov-2 s protein differ after vaccination in those who have had a previous sars-cov-2 infection compared to covid-19 naive individuals. the secondary objective is to improve the understanding of the cellular and serological immune response after vaccination against covid-19 in these groups. individuals with and without pre-existing immunity to covid-19 are included in the study. they are included after informed consent at sites where they receive vaccines against covid-19 within the national and regional vaccine campaign. the study includes all approved covid-19 vaccines with marketing authorization in sweden. persons are enrolled after the first or second dose of vaccination and followed 4 years after vaccination. blood is collected at inclusion and 3 months, 6 months, 1 year, 2 years, 3 years and 4 years after vaccination to assess the immune response. data on sex, age, body mass index, medical history and concomitant medication is collected. the study is a follow-up study after vaccination and approved by the swedish medical products agency (eudract 2021-000683-30). regular monitoring of the study is performed by the clinical trial unit at umeå university hospital.

Eligibility criteria:
inclusion criteria: * consents to participate in the study * age ≥ 18 years exclusion criteria: * age \<18 years * incapable of giving informed consent * contraindication to vaccination * severe disease * ongoing treatment that is judged to affect the vaccine response (does not include rituximab which is allowed after individual consideration). steroids \> 15 mg orally per day.

Keywords: immune response immunoglobulin g
naturalistic teaching strategies in children with autism

Conditions: Autism Spectrum Disorder

Summary: the study will show the effect of naturalistic teaching strategies and picture exchange communication systems in children with an autism spectrum disorder. there will be two groups in this study. one control group and the other experimental group. one group will be provided with the naturalistic teaching strategies and pecs therapy both and the other group will be provided with the pecs therapy. the research will be conducted within the duration of six months after the approval from basr. the two groups will be first assessed using the portage early education program and pecs manual. after 20 sessions of respective therapeutic techniques, both of the groups will be reassessed. the results of both of the groups will be then compared and conclusions will be drawn.

the naturalistic teaching approach is both adaptive and reactive to the needs of the kids with autism. its methods are designed to be incorporated into the routines of children with an autism spectrum disorder. the naturalistic methods are intended to mimic the natural instructions a child receives in a variety of contexts. pictureexchange communication system (pecs) is a unique communication training program that was developed as a means of evading some shortcomings associated with these strategies. many individuals with autism are candidates for augmentative and alternative communication (aac) systems, either to supplement (i.e., augment) their existing speech or to act as their primary (i.e., alternative) method of expressive communication. presently, aided, picture-based aac systems are used more frequently and successfully with individuals with asd. pecs consists of six phases and begins by teaching an individual to give a single picture of a desired item or action to a "communicative partner" who immediately honors the exchange as a request.

Eligibility criteria:
inclusion criteria: * children who will be diagnosed with autism spectrum disorder and with speech and language impairments and will fall in the chronological age of language development (3-8) years * both genders * children who will have a vocabulary of 0-10 meaningful words * children with mild and moderate autism exclusion criteria: children already taking speech therapy sessions * children with severe to a profound level. * children with any other disorder along with autism
comparison of customized and standard total ankle prostheses

Conditions: Ankle Osteoarthritis

Summary: the objective of this study is to compare primary total ankle replacement (tar) performed with a customized procedure (prostheses customized for each patient based on his or her ankle morphology reconstructed from tomographic scans, and implanted via cutting guides customized for the patient) with standard primary tars, considering: objective radiological results, subjective patient outcomes, and overall costs of both procedures


Eligibility criteria:
inclusion criteria: * male and female subjects older than 40 years and younger than 75 years (≥ 40 age ≤ 75 years) with arthrosis at the unilateral tibio-tarsal joint who are candidates for primary total ankle replacement. * consenting patients and able to complete scheduled study procedures and follow-up evaluations. * patients who have signed the "informed consent" approved by the ethics committee. exclusion criteria: * social conditions (homeless patients, with restrictions on personal freedom) * asa 3 and 4 * deep venous insufficiency lower limbs * history of erisipelas lower limbs * neurological or psychocognitive disorders * neurological diseases * axial deformities of ankle \>15° * personal or family history of dvt or ep * prosthetic and/or arthrodesis surgeries at another lower extremity joint except that candidate for ankle prosthesis) * pregnant women * patients with rheumatic diseases * patients that requires ancillary surgical procedures

Keywords: replacement customized tar arthroplasty radiographic angles clinical scores
refractive surgery and optive compatibility study

Conditions: Dry Eye Syndromes

Summary: to assess the compatibility of optive with refractive surgery (prk and lasik) post-operatively.


Eligibility criteria:
inclusion criteria: * men and women 18 and over * patients undergoing refractive surgery exclusion criteria: * concurrent ocular conditions or pathology that could affect patient's ability to complete study * concurrent use of topical medications other than study medications * use of systemic medications with ocular drying sequelae: * antihistamines * decongestants * antispasmotics * antidepressants

Keywords: compatibility of optive after prk or lasik
safety and efficacy study of subjects that are taking saxagliptin added onto metformin xr compared to subjects taking metformin xr alone

Conditions: Type 2 Diabetes

Summary: this protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (xr) versus metformin xr alone


Eligibility criteria:
inclusion criteria: * ≥18- and ≤77-years-old * type 2 diabetes * taking metformin immediate release (ir) or xr ≥1500 mg for at least 8 weeks as monotherapy * glycosylated hemoglobin (a1c) ≥7% and ≤10% * body mass index (bmi) ≤40 kg/m2 exclusion criteria: * women of childbearing potential unable or unwilling to use acceptable birth control * women who are pregnant or breastfeeding * significant cardiovascular history * active liver disease * renal impairment