Kornimate/medical-research-clean huggingface dataset:
safety, tolerability and pharmacokinetic study of mt-3995 at a low dose in subjects with diabetic nephropathy

Conditions: Diabetic Nephropathy

Summary: the purpose of this study is to evaluate safety, tolerability and pharmacokinetics of mt-3995 in subjects with diabetic nephropathy.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ace-i) or angiotensin ii receptor blocker (arb) * glycosylated haemoglobin (hba1c) ≤10.5% * subject with albuminuria exclusion criteria: * subjects with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus (cushing's syndrome, steroidogenic diabetes). * serum potassium level \ 5.0 mmol/l * subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation * subjects with clinically significant hypotension

Keywords: diabetic nephropathy
nonthyroidal illness syndrome in sbs

Conditions: Nonthyroidal Illness Syndrome; Short Bowel Syndrome

Summary: nonthyroidal illness syndrome (ntis) is prevalent in critical illness; it is associated with poor outcomes. however, few studies have focused on the relationship between ntis and short bowel syndrome (sbs). the aim of this study was to investigate the incidence, etiology, and prognosis of ntis and its correlation in clinical variables in adult patients with sbs.

nonthyroidal illness syndrome (ntis), also known as euthyroid sick syndrome or low triiodothyronine (t3) syndrome, is a condition characterized by decreased serum concentrations of t3 and low or normal plasma concentrations of thyroxine (t4) without a compensatory increase in the serum levels of thyroid stimulating hormone (tsh). however, such typical changes differ from those in primary or secondary thyroid disorders. ntis refers to distortions in thyroid function without thyroid disease caused by various critical illnesses. this condition has been described in different acute and chronic disease states over the past 30 years, including sepsis, starvation, trauma, burns, myocardial infarction, crohn's disease, enterocutaneous fistulas, chronic kidney disease, and major surgery. short bowel syndrome (sbs), the most common form of intestinal failure, is a rare condition resulting from the loss of portions of the intestine, typically because of extensive surgical resection or loss of intestinal function. patients with sbs often stuffer from intestinal insufficiency or intestinal failure because they are unable to maintain fluid and nutrient balances on a normal diet. therefore, sbs can cause various metabolic and physiologic disturbances, many of which are associated with growth, intestinal adaptation, and hormone secretion. many previous studies of sbs have evaluated growth hormone, glucagon-like peptide-1, glucagon-like peptide-2, vitamin d and parathyroid hormone, peptide yy, and ghrelin. however, few studies have reported the association between sbs and the hypothalamic-pituitary-thyroid axis and its balance. the present study was performed to evaluate the association of thyroid hormone disturbance and sbs in adult patients. because ntis is the main type of thyroid hormone disturbance, we further investigated the incidence, underlying mechanisms, and correlation with clinical variables and prognosis of ntis in adult patients with sbs.

Eligibility criteria:
inclusion criteria: (1) adult patients with sbs, defined as intestinal malabsorption disorder resulting from extensive bowel resection with a remnant small intestine length of greater than 200 cm, admitted to a clinical nutrition center. - exclusion criteria: 1. age less than 18 years; 2. previous history of thyroidal, hypophyseal or hypothalamic disease; 3. lactational or gestational period; 4. medication history of thyroidal hormone or antithyroid drugs; 5. craniocerebral injury; 6. attack of coronary heart disease, myocardial, or cerebral infarction in the past month; 7. intracranial infection or hemorrhage in the past month. -
pfn-a augmentation for intertrochanteric femoral fractures

Conditions: Intertrochanteric Fracture

Summary: this study evaluates the potential negative effect of cement augmentation in the femoral head on viability of the head. half of the participants will have the standard intramedullary nail (pfn-a; proximal femoral nail augmentation), while the other half will get the standard nail plus cement augmentation.

cement augmentation is believed to increase the bone implant interface and therefore decrease the risk of implant cut-out of the femoral head. the cement used in previous studies has produced heat and thermal necrosis on bone cells. the cement used in this study (traumacemv+) is manufactured specially for this implant and for the augmentation of this implant. traumacemv sets under low temperature (40 degrees celsius) and we do not anticipate any heat necrosis. the volume effect of the cement could theoretically also damage the blood flow in the femoral head. there have been no negative effects in big series of patients operated with this technique. the aim of this study is to quantify the viability of the femoral head with the use pet-ct (positron emission tomography with simultaneous computed tomography) including a radioactive isotope (fluorine-18) and the use of threedimensional computed tomography.

Eligibility criteria:
inclusion criteria: * intertrochanteric hip fracture ao (arbeitsgemeinschaft für osteosynthesefragen) 31-a1 or ao 31-a2 * healthy contralateral hip * asa (american society of anesthesiologists) physical status class i or ii exclusion criteria: * dementia

Keywords: augmentation pet-ct positron emission tomography fluorine-18
early intervention coping kids (tim) follow up study

Conditions: Anxiety Disorders; Depression

Summary: the project objectives are to investigate if a preventive intervention targeting anxious and sad children aged 8 to 12 years has haf the anticipated long-term effects, 5 years after receiving the intervention. hence: will an indicated intervention reduce the incidence of common mental disorders in youth in the long term? the current study is a 5 year follow up of the previously completed rct called the tim-study (clinical trials identifier: nct 02340637). the aim of this study is to determine the long-term effects of the intervention to examine if true preventive effects are achieved as indicated by lower symptom levels, better functioning og fewer diagnosis of anxiety and depression 5 years after receiving an indicated preventiv intervention.


Eligibility criteria:
inclusion criteria: * participants who participated in the previous randomized controlled tim study (children then aged 8- 12 years selfreporing elevated symptom levels of anxiety and/or depression) exclusion criteria: * all earlier participats from the tim study may enter the follow up study * participants who chose to not participate in the 5-year follow-up of the tim study are excluded from the follow-up study.

Keywords: anxiety depression school absenteeism youth
subtotal parathyroidectomy or total parathyroidectomy with autograft in chronic kidney disease patients under dialysis

Conditions: Hyperparathyroidism, Secondary

Summary: this study evaluates the metabolic and clinical results of two well recognized and accepted surgical techniques in the management of severe hyperparathyroidism in patients under regular dialysis treatment.

prospective randomized trial in the surgical management of severe hyperparathyroidism of chronic kidney disease stage v under dialysis. patients will be randomized and they will be submitted to subtotal parathyroidectomy or total parathyroidectomy with immediate heterotopic autograft of 45 or 90 fragments of parathyroid tissue.

Eligibility criteria:
inclusion criteria: * stage v chronic kidney disease patients under regular dialysis treatment with severe hyperparathyroidism requiring parathyroidectomy exclusion criteria: * patients refusing to participate in the study (they will receive standard surgery), * patients unable to attend regular follow up consultations, * patients with a successful kidney transplant at the moment of parathyroidectomy, * patients submitted to any previous surgery of the thyroid or parathyroid, * patients with chronic kidney disease but not under dialysis

Keywords: parathyroidectomy renal insufficiency, chronic
a pilot study of repetitive transcranial magnetic stimulation

Conditions: Stroke; Mirror Therapy; Transcranial Magnetic Stimulation

Summary: stroke patients often have long-term upper limb dysfunction. currently, there is still no specific clinical treatment for nerve damage. after acute treatments of stroke, patients' motor ability can only improve by spontaneous recovery of brain and rehabilitation treatment. transcranial magnetic stimulation uses a magnetic field pulse generated by a coil outside the skull to pass through the skull. it uses the principle that magnetic electricity can generate currents, which activates nearby brain areas or changing the relationship between the left and right brains. transcranial magnetic stimulation is a non-invasive, safe treatment. mirror therapy is an emerging rehabilitation method in recent years. as mirror therapy, therapists ask the patient to place the affected hand behind the mirror while looking at the image reflected by the unaffected upper limb. during mirror therapy, patients have to perform upper limb activities and imagine that the affected upper limb is performing the same action. as mentioned above, transcranial magnetic stimulation and mirror therapy improve the recovery of stroke patients by two different ways. currently, there are no studies that combine these two treatments. therefore, our study hopes to initially explore the efficacy of transcranial magnetic stimulation and the efficacy of transcranial magnetic stimulation combined with mirror therapy.


Eligibility criteria:
inclusion criteria: * at least 1 month after stroke * manual muscle strength \< 5 exclusion criteria: * history of epilepsy * has other central nervous system diseases * has electric medication pump * has implant at inner ear
tolerability, pharmacokinetics and efficacy of zsp1603 in patients with idiopathic pulmonary fibrosis （ipf）

Conditions: Idiopathic Pulmonary Fibrosis (IPF)

Summary: this study was divided into two parts. the first part was a dose escalation study: a open label dose escalation design was used to evaluate the safety, tolerance and pharmacokinetic characteristics of zsp1603 in ipf patients. the second part was a randomized double-blind placebo-controlled design was used to preliminatively investigate the efficacy and safety of zsp1603 in the treatment of ipf at the target dose.


Eligibility criteria:
inclusion criteria: * ipf diagnosed, according to 2018 american thoracic society (ats), european respiratory society (ers), japanese respiratory society (jrs), latin american thoracic association (alat) ipf guideline for diagnosis and management; * dlco (corrected for hb): 30%-79% predicted of normal; * fvc\>= 50% predicted of normal; exclusion criteria: * fev1/fvc\< 0.7; * pao2 in resting state without oxygen inhalation \< 50mmhg; * subjects who were likely to be lung transplant recipients or expected to survive less than 1 year during the study period as assessed by the investigator; * poorly controlled cardiovascular and cerebrovascular diseases; * patients who had used nidanib, pirfenidone, interferon, n-acetylcysteine, azathioprine, cyclophosphamide, cyclosporine, prednisone \> 15mg/ day (or equivalent dose of other glucocorticoids) within 4 weeks before enrollment; those who had used chinese herbal medicine or acupuncture treatment within 1 week before enrollment;
impact of transcatheter aortic valve implantation (tavi) on cognitive functions

Conditions: Cognition Disorder

Summary: interventional implantation of the aortic valve (transcatheter aortic valve implantation; tavi) may alter neurocognitive functions. we aim to differentiate the changes in cognitive functions after a tavi.

interventional implantation of the aortic valve (transcatheter aortic valve implantation; tavi) is the treatment of choice for patients with symptomatic aortic valve stenosis \>75 years with comorbidities. the reduction in complications and also in mortality after tavi is due, among other things, to the constant further development of tavi devices but also to improved implantation technologies. nevertheless, neurological complications are rare but of relevant impact. these are a.e. due to the passage of the tavi system into an aorta that is often burdened with atheromatous plaques or the necessity to predilate the calcified aortic valve. studies using cerebral magnetic resonance imaging (mri) show that the vast majority of patients after tavi had lesions in the brain that correspond to at least minimal cerebral infarction. even if these are asymptomatic, various studies have shown that initially asymptomatic infarcts may be associated with an increased incidence of dementia and cognitive impairment, as well as being predictors of later symptomatic infarctions. changes in hemodynamics after removal of the aortic stenosis could, on the other hand, improve neurocognitive function. interestingly, the standard methods primarily investigate motor deficits, while neurocognitive function were currently not tested. the influence of a tavi on the latter functions is therefore unknown. in this study, we aim to differentiate the changes in cognitive functions after a tavi immediately after the procedure and after 6 months.

Eligibility criteria:
inclusion criteria: * planned tavi implantation * age ≥ 60 * intelligence quotient \> 80 * sufficient knowledge of german * normal or corrected vision and hearing exclusion criteria: * serious neurological or psychiatric diseases that make participation in the trial procedure impossible * oncological disease with a life expectancy \< 12 months * pregnancy

Keywords: transcatheter aortic valve implantation (tavi) cognitive function aortic stenosis stroke frailty
glycaemic control of weekly laps-exendin versus placebo in subjects of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine the optimal dose or doses of hm11260c, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (t2dm).


Eligibility criteria:
inclusion criteria: * ages eligible for study : 18 years to 74 years * genders eligible for study : male and female * diagnosed with t2dm * received diet and exercise therapy with or without metformin monotherapy * hba1c levels of between ≥ 7.0% and ≤ 10.0% * females of childbearing potential who are not pregnant and agree to use a reliable method of birth control * written informed consent must be obtained exclusion criteria: * pregnant or nursing (lactating) women * diagnosis of type 1 diabetes mellitus * uncontrolled diabetes defined as a fpg level of \> 240 mg/dl * a significant change in body weight in the 3 months before screening * any history of gi intolerance * personal or family history of medullary thyroid cancer (mtc) or a genetic condition that predisposes to mtc * known history of chronic pancreatitis * a history of alcohol or drug abuse or drug addiction

Keywords: glycaemic control hm11260c placebo safety tolerability type 2 diabetes mellitus efficacy t2dm glycated haemoglobin (hba1c) glycosylated haemoglobin (hba1c) glucagon-like peptide-1 (glp-1) agonists blood sugar levels fasting plasma glucose (fpg)
hypo-fractionated postoperative imrt in prostate cancer

Conditions: Prostate Cancer

Summary: to report the outcome of hypo-fractionated radiotherapy after radical prostatectomy (rp) for prostate cancer (pca) using imrt-sib. 124 patients with pca at high risk of relapse after rp or diagnosis of biochemical relapse were included. patients received 62.5 gy to the prostate bed (pb) and 45 gy to pelvis nodes in 25 fractions. androgen suppressive therapy was prescribed based on nccn risk categories. median follow-up was 30 months.

to report the outcome of hypo-fractionated radiation therapy after radical prostatectomy (rp) for prostate cancer (pca) using intensity-modulated radiation treatment with simultaneous integrated boost (imrt-sib). one hundred and twenty-four patients with pca at high risk of relapse after rp or diagnosis of biochemical relapse were included in this phase ii study (adjuvant: 106 patients, salvage: 18 patients). all patients received 62.5 gy to the prostate bed (pb) and 45 gy to pelvis nodes in 25 fractions. androgen suppressive therapy was prescribed based on nccn risk categories. acute and late toxicities were recorded and evaluated according to rtog (radiation therapy oncology group) criteria and rtog-eortc (european organization for research and treatment of cancer) scale, respectively. median follow-up was 30 months (13-92).

Eligibility criteria:
inclusion criteria: * \> 18 years * prior radical prostatectomy with or without lymphadenectomy * high-risk patients (positive surgical margins, and/or extracapsular extension, and/or seminal vescicle invasion, and/or probability of nodal metastasis \> 7% calculated by the roach formula after pelvic lymph node dissection with ≤ 13 nodes removed, and/or presence of any positive pelvic nodes) or patients with biochemical relapse (initial post-surgery serum psa equal or above 0.2 ng/ml with a second confirmatory psa of the same value) * ecog performance status 0-1 * adequate bone marrow function (hemoglobin concentration \> 8 g/dl, white blood cell count \> 3,000/ mm³, platelet count \> 75,000/ mm³) * pre-treatment computed tomography (ct) scan or magnetic resonance imaging (mri) of the abdomen and pelvis * bone scan * informed consent exclusion criteria: * prior pelvic radiotherapy * distant metastases * macroscopic residual tumor * pelvic or para-aortic nodes at re-evaluation imaging after surgery * secondary malignancies * genetic syndromes of hyper-radio-sensitivity * chronic inflammatory bowel disease * previously treated with androgen deprivation therapy * previously treated with chemotherapy for prostate cancer

Keywords: adjuvant hypofractionation imrt phase i-ii prostate neoplasms radiotherapy
the impact of the covid-19 pandemic on schizophrenia patients registered with the community mental health center

Conditions: Schizophrenia

Summary: this study aimed to examine the effect of the covid-19 pandemic on schizophrenia patients registered to the community mental health center (cmhc) in terms of depression, suicide risk, and tendency to violence.

the study was conducted on patients registered to the ministry of health kartal dr. lütfi kırdar city hospital adatepe community mental health center and was followed up regularly. it was carried out on 108 individuals who met the diagnosis of schizophrenia according to the dsm-v (american psychiatric association 2013) and met the inclusion criteria. individuals who were respectively classified as hospitalized group (hg) during the covid-19 pandemic period (n=39), non-hospitalized with emergency care group (nhecg) without hospitalization (n=37), and non-hospitalized with non-emergency care group (nhnecg) (n=32). individuals who had been diagnosed with schizophrenia for at least two years, were not in the active phase of the disease, did not have organic mental disorders, did not have any other psychiatric diseases were included in the study. in the study, the socio-demographic questionnaire, the calgary depression scale in schizophrenia (cdss), the buss-perry aggression questionnaire (bpaq), and the suicide probability scale (sps) were used.

Eligibility criteria:
inclusion criteria: * between the ages of 18-65, * receiving service from kartal dr. lütfi kırdar city hospital adatepe cmhc, * having been diagnosed with schizophrenia for at least two years, * not being in the active phase of the disease, * not having an organic mental disorder, * not having an additional psychiatric illness, and * being literate exclusion criteria: * individuals with cognitive and physical dysfunction, * mental retardation, different psychiatric diseases that would prevent interview or testing, and * those who did not consent to participate in the study
ultrasound guided a1 pulley release for the treatment of trigger finger

Conditions: Surgical Release of Ai Pulley Trigger Finger

Summary: in this randomized, prospective clinical trial, patients with trigger finger or trigger thumb, will be treated with two different methods; ultrasound-guided release of the first annular pulley or open surgical release of a1 pulley. results will be compared regarding functional, clinical and cosmetic outcome.


Eligibility criteria:
inclusion criteria: * patients with resistant -after conservative treatment- trigger finger or trigger thumb, suffering at least for 3 months. exclusion criteria: * patients under 18 years old, these who were treated with a previous operation or a corticosteroid injection for their disease and those who were suffering by inflammatory arthritis, tumor or autoimmune disease. * patients with multiple trigger fingers
combination chemotherapy in treating patients with metastatic ovarian cancer or non-small cell lung cancer

Conditions: Lung Cancer; Neurotoxicity; Ovarian Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug and giving the drugs in different combinations may kill more tumor cells. purpose: randomized phase ii double-blinded trial to study the effectiveness of paclitaxel and carboplatin given with either amifostine or placebo in patients with metastatic stage iii or stage iv ovarian cancer or metastatic stage iii or stage iv non-small cell lung cancer.

objectives: i. determine whether patients with metastatic ovarian and non-small cell lung cancer receiving carboplatin and paclitaxel have significantly fewer neuropathic events when treated with amifostine. outline: this is a randomized, parallel group, double blind, controlled study. patients are randomized to either the amifostine or control group. all patients receive intravenous paclitaxel over 3 hours, followed by carboplatin once every 3 weeks for 6 cycles. patients who are randomized to the amifostine group receive intravenous amifostine administered as a 15 minute infusion 30 minutes prior to paclitaxel therapy. patients randomized to the control group receive an intravenous placebo solution. patients are discontinued from the study if they have disease progression or unacceptable toxic effects after 2 cycles of treatment. patients are followed monthly for 8 months post treatment. projected accrual: a total of 80 patients will be accrued (40 with advanced ovarian cancer and 40 with advanced non-small cell lung cancer) within 2 years.

Eligibility criteria:
disease characteristics: histologically proven stage iii/iv ovarian or non-small cell lung cancer patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 3.0 mg/dl renal: creatinine no greater than 2 mg/dl other: not pregnant or nursing no history of platinum, paclitaxel or amifostine hypersensitivity prior myelosuppressive events allowed no clinically significant ascites prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior chemotherapy within 1 month of study endocrine therapy: not specified radiotherapy: no prior radiation therapy within 1 month of study surgery: not specified

Keywords: stage iii non-small cell lung cancer stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer stage iv non-small cell lung cancer neurotoxicity