Kornimate/medical-research-clean huggingface dataset:
adjuvant vitamin d with corticosteroids in active crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to determine whether the addition of vitamin d to standard corticosteroids improves onset of remission in active crohn's disease, a form of inflammatory bowel disease (ibd).

crohn's disease is a form of inflammatory bowel disease (ibd). it is caused by abnormal immune-mediated gut inflammation and is both chronic and difficult to treat. symptoms are often unpleasant (e.g. abdominal pain, diarrhoea, disfiguring fistulation) and often lead to surgery to remove diseased bowel. there is emerging evidence that vitamin d, a nutrient largely produced in the skin upon exposure to sun-light, may possess properties regulating the immune system in ibd. in addition, vitamin d deficiency appears common in inflammatory bowel disease. this study aims to determine if the addition of vitamin d to standard corticosteroid treatment in active crohn's disease helps to achieve remission (resolution of symptoms).

Eligibility criteria:
inclusion criteria: 1. active crohn's disease activity (cdai) score \>200 to 450; 2. diagnosis of ibd and distribution of disease previously confirmed 3. the participant able to give informed consent form; 4. stable doses of the following concurrent ibd medications prior to inclusion: * 5-aminosalicylates (≥4 weeks) * thiopurines (≥8 weeks) * no corticosteroids (within 4 weeks) * no biological agents (within 8 weeks). exclusion criteria: 1. unable to give informed written consent; 2. co-existence of any other chronic inflammatory conditions 3. failure to meet concurrent ibd medication criteria; 4. hypercalcaemia (corrected serum calcium \> 2.66 mmol/l) or history of vitamin d hypersensitivity; 5. diagnosis of any of the flowing: active tuberculosis, sarcoidosis, hyperparathyroidism, pseudohyperparathyroidism, nephrolithiasis, silicosis, liver failure, renal failure or malignancy, active tb, sarcoidosis or lymphoma or other granulomatous disease; 6. known intolerance or contraindication to vitamin d or trial medication (i.e. corticosteroids / infliximab); 7. biochemical disturbance at enrolment: serum corrected calcium \> 2.66 mmol/l) or serum creatinine \>250 micromol/l; 8. pregnancy or breast-feeding.

Keywords: crohn's disease inflammatory bowel disease vitamin d randomised placebo
study of teriflunomide in reducing the frequency of relapses and accumulation of disability in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the primary objective was to determine the effect of teriflunomide on the frequency of relapses in patients with relapsing multiple sclerosis (ms). secondary objectives were: * to evaluate the effect of teriflunomide on the accumulation of disability as measured by expanded disability status scale \[edss\], the burden of disease as measured by magnetic resonance imaging \[mri\] and patient-reported fatigue; * to evaluate the safety and tolerability of teriflunomide.

the study period per participant was approximatively 128 weeks broken down as follows: * screening period up to 4 weeks, * 108-week double-blind treatment period (approximatively 2 years)\*, * 16-week post-treatment elimination follow-up period. '\*' participants successfully completing the week 108 visit were offered the opportunity to enter the optional long-term extension study lts6050 - nct00803049.

Eligibility criteria:
inclusion criteria: * multiple sclerosis \[ms\] subject who was ambulatory (edss of ≤ 5.5) * exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing); * meeting mcdonald's criteria for ms diagnosis; * experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial; * no relapse onset in the preceding 60 days prior to randomization; * clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone \[acth\] or systemic steroid treatment. exclusion criteria: * clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease; * significantly impaired bone marrow function; * pregnant or nursing woman; * alcohol or drug abuse; * use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment; * any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;

Keywords: multiple sclerosis relapsing remitting secondary progressive progressive relapsing
efficacy of inspiratory muscle training associated with manual techniques in individuals with gerd

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: the objective of this clinical trial is to investigate the efficacy of inspiratory muscle training (imt) combined with manual techniques for the lower esophageal sphincter (mtles) and diaphragmatic release (drt) in patients with gastroesophageal reflux disease (gerd). the main questions it aims to answer are: 1. if the combination of imt, drt, and mtles can improve gerd symptoms and patients' quality of life. 2. if the home-based imt protocol, with weekly adjustments, and the manual techniques applied twice a week can have a positive impact on various clinical measures, such as pressure at the lower esophageal sphincter, reflux episodes, and quality of life. the researchers will compare three groups: group 1 (imt), group 2 (imt + drt + mtles), and group 3 (control, sham), to see if the group receiving imt combined with drt and mtles shows greater improvements compared to the control group. participants will perform inspiratory muscle training at home, following a protocol adjusted weekly, and will receive manual techniques twice a week.

the imt protocol will be performed at home with a load set at 50% of maximal inspiratory pressure (mip) and adjusted weekly, while manual techniques will be applied twice a week at lacap. outcomes include mean pressure at the gastroesophageal junction (esophageal manometry), number of reflux episodes and acid exposure time (impedance-ph monitoring), diaphragmatic mobility and thickness (ultrasound), respiratory muscle strength (manovacuometry), heart rate variability (heart rate monitor), and reflux symptoms and quality of life (questionnaires). it is expected that the combination of imt, drt, and mtles will improve gerd symptoms and positively impact patients' quality of life, providing an effective and less invasive alternative compared to conventional interventions.

Eligibility criteria:
inclusion criteria: * individuals diagnosed with gastroesophageal reflux disease (gerd) * using 20 mg of proton pump inhibitors (ppis). exclusion criteria: * individuals with a hiatal hernia \>3 cm, * chronic lung diseases (chronic obstructive pulmonary disease and interstitial lung diseases) * severe heart diseases, * history of previous abdominal and/or thoracic surgeries, rib fractures within the past year, * severe osteoporosis * bmi \>30 kg/m²

Keywords: inspiratory muscle training (imt) diaphragmatic release manual techniques for the lower esophageal sphincter
clinical and hemodynamic evaluation after venous recanalization of post-thrombotic iliofemoral syndromes

Conditions: Venous Recanalisation

Summary: post-thrombotic syndrome (pts) is the most common chronic complication of deep vein thrombosis (dvt). the endovascular recanalization and stenting technique has become the gold standard treatment for medically resistant and disabling pts. stent thrombosis is a significant complication of this procedure; the risk factors for thrombosis are poorly understood. monitoring the patency of the stent is a key component in maintaining clinical success. doppler ultrasound is the first-line diagnostic tool for monitoring patients with venous stents, and has the potential to allow accurate assessment of venous stent obstruction. absence of validated morphological and hemodynamic echodoppler criteria for the follow-up of these stents. • main objective: clinical and hemodynamic results of venous recanalisations by stenting in the chronic phase • secondary objective (s): * external validation of hemodynamic criteria proposed in the literature to detect venous stent obstruction * risk factors for venous stent restenosis


Eligibility criteria:
inclusion criteria: - disabling post-thrombotic syndrome (venous claudication) after at least 6 months of proximal deep vein thrombosis. exclusion criteria: * inability to consent * age \<18 years old * life expectancy \<3 months * incomplete medical records * lost in follow up

Keywords: post-thrombotic syndrome deep vein thrombosisa endovascular recanalization and stenting morphological and hemodynamic echodoppler criteria venous stent restenosis
improving social relationships for adolescents with central disorders of hypersomnolence

Conditions: Narcolepsy Type 1; Narcolepsy Type 2; Idiopathic Hypersomnia

Summary: the goal of this study is to test a web-based psychoeducational resource for adolescents with central disorders of hypersomnolence and their families. the investigators hope to assess the website's usability, acceptability, and feasibility, as well as its potential effect on social relationship health. participants will be asked to review the content of the psychoeducational websites. the participants will then provide feedback on the website, as well as the adolescent's social relationships and social health before and after reviewing the website through online surveys.

the american academy of sleep medicine's clinical practice guideline task force concluded that "reliance on medications alone to treat cns hypersomnia conditions is likely insufficient." our stakeholder data demonstrated that this issue is a significant challenge in the domain of social relationship health for children with narcolepsy type 1 and 2 (nt1/nt2) and idiopathic hypersomnia (ih). with one peak for symptom onset in adolescence, a critical period in a child's social development, children with nt1/nt2/ih and their families report significant social sequelae of the disorder and its treatment that have lifelong implications. to address this important, yet consistently overlooked real-life concern for adolescents with cdh, the investigators intend to assess an online psychoeducational website that the investigators designed to provide families with the knowledge and resources to improve the adolescent's social relationship health. a total of 45 families will participate in a single-arm usability, feasibility, and acceptability trial. eligible families will be provided with instructions on how to access the website. participants will be encouraged to return to the website as often as needed to review content. for the purposes of this study, participants will be instructed to review all intervention materials within one month of receiving website access. the participants will then complete feedback questionnaires on the secure online platform redcap. this study will inform a future randomized controlled trial testing the efficacy of the investigators' intervention. the investigators' stakeholder informed program will be the first of its kind for children with nt1/nt2/ih, with the potential to be widely disseminated.

Eligibility criteria:
inclusion criteria: * adolescent from 10-17 years of age and parent of the adolescent * adolescent has physician-diagnosed narcolepsy type 1 or type 2, or idiopathic hypersomnia * english fluency * interest in learning more about how to improve social health for adolescents with a cdh

Keywords: narcolepsy type 1 narcolepsy type 2 central disorders of hypersomnolence idiopathic hypersomnia social relationships adolescents
fixed inclination humeral cut

Conditions: Shoulder Osteoarthritis

Summary: the purpose of the present study is to determine if a standard humeral cut using a fixed neck shaft angled prosthesis for patients undergoing anatomic tsa is able to restore normal glenohumeral relationships as compared to a variable neck shaft angle prosthesis.


Eligibility criteria:
inclusion criteria: 1. patients 18 years or older 2. primary glenohumeral osteoarthritis 3. intact rotator cuff 4. primary anatomic shoulder arthroplasty exclusion criteria: 1. revision arthroplasty 2. reverse shoulder arthroplasty candidates 3. cognitive or behavioral problems which would preclude informed consent
comparison of 2 antifungal treatment (empirical versus pre-empirical) strategies in prolonged neutropenia

Conditions: Malignant Hemopathy; Duration of Neutropenia Following Chemotherapy > 10 Days

Summary: empirical antifungal treatment is the gold standard for patients who are neutropenic and have persistent fever under broad-spectrum antibiotics. the rational is that fungal infections are difficult to early diagnose, and are life-threatening. historical trials have shown a small benefit of survival when this strategy is used. according to the drug usde for this strategy, safety and costs may be concerns. however, since this routine practice has been implemented in hematology, new non-invasive biological diagnostic methods are available to early diagnose fungal infections, such as galactomannan antigenemia for aspergillosis. the goal of our study is to show that limiting the administration of antifungals in this setting to patients with clinical foci of infection, or to patients with a positive galactomannan antigenemia reduces the risk of toxicity of the antifungal drug, and has no impact on the overall mortality of patients treated with chemotherapy for hematologic malignancies.

patients are eligible if they have an hematologic malignancy, and receive chemotherapy with an expected neutropenic phase of \> 10 days. patients are randomized according to a 1:1 ratio to receive either the usual empirical strategy (antifungals are introduced if they have persistent fever after 4 days of broad-spectrum antibacterials) or the pre-empirical strategy (administration of antifungals is limited to patients with pneumonia, septic shock, sinusitis, grade 3 mucositis, aspergillus colonization, liver or splenic abscesses, or positive galactomannan antigenemia). the antifungals administered are deoxycholate amphotericin b or liposome amphotericin b, according to the creatinin clearance. this strategy is applied during the first 14 days of persistent fever, then the therapy is left at the discretion of the investigator. the primary endpoint is survival at neutrophil recovery, or, in case of persistent neutropenia, at day 60 at the latest. secondary objectives are the incidence of invasive fungal infections (ifi), ifi-free survival, number of febrile days, and renal function at study completion.

Eligibility criteria:
inclusion criteria: * malignant hemopathy * induction or consolidation phase of chemotherapy, with expected neutropenia (\< 500/mm3) during at least 10 days * hospitalisation during aplasia exclusion criteria: * allogeneic haematopoietic stem cell transplants * previous fungal infection according to eortc-msg criteria * active fungal infection according to eortc-msg criteria * previous anaphylactic intolerance to polyenes * known aspergillosis infection * sepsis * pneumopathy

Keywords: aspergillosis antifungal therapy empirical antifungal treatment
surgery following immune checkpoint inhibitions for controlled disease in recurrent or metastatic dmmr/msi-h colorectal cancer

Conditions: Colorectal Cancer

Summary: surgical resection for residual lesions could significantly improve the prognosis in metastatic colorectal cancers (crcs) after systemic treatments, yet the necessity of resecting residual lesions after immune checkpoint inhibitions (icis) remains controversial in mismatch repair-deficient (dmmr) or microsatellite instability-high (msi-h) diseases. we retrospectively enrolled recurrent or metastatic dmmr/msi-h crcs who received surgerys from sun yat-sen university cancer center. patients without disease progression after at least 2 cycles of icis were included. demographic and clinicopathological data were collected and analyzed. relapse-free survival (rfs) after surgery were analyzed.


Eligibility criteria:
inclusion criteria: 1. pathologically confirmed crc with measurable disease per response evaluation criteria in solid tumors (recist, version 1.1)20; 2. definite pathological or radiological evidence of recurrent or distant metastasis; 3. received at least 2 courses of icis; 4. confirmed as dmmr by immunohistochemical method or msi-h by polymerase chain reaction or next-generation sequencing; 5. receiving therapeutic surgical treatment for residual lesions or tumor sites and achieving no evidence of disease (ned) ; 6. no progression within the duration of preoperative icis exclusion criteria: -
healthcare cost and resource utilization related to metastatic renal cell carcinoma treatment with intravenous and oral agents

Conditions: Renal Cell Carcinoma

Summary: a retrospective study to evaluate healthcare cost and resource utilization for patients with metastatic renal cell carcinoma who have been treated with iv or oral agents


Eligibility criteria:
inclusion criteria: * diagnosis with metastatic renal cell carcinoma * prescription/administration of one of the iv or oral agents examined in the study exclusion criteria: * patients with other primary cancer diagnosis before rcc diagnosis * patients with pregnancy or hiv/aids
evaluation of vascular toxicity of immune checkpoint inhibitors in patients head and neck or lung cancer

Conditions: Head and Neck Cancer; Lung Cancer

Summary: since the introduction of immune checkpoint ihibitors (icis) in cancer treatment, numerous studies have investigated different patient profiles to identify those who benefit from this class of drugs. currently, hundreds of studies are being conducted with the aim of increasing the benefit of these therapies by combining icis with other treatments: immunomodulators, cytotoxics, targeted therapies, including cancer vaccines, which are peptides or rna injected to trigger or increase a specific immune response against the tumor. other approaches exist, such as oncology-specific "basket" studies, to focus on a genetic mutation independently of tumor location and determine whether a drug could treat the same genetic mutation found in several different locations. to date, icis are part of standard management in the us for patients with several diseases: advanced melanoma, nsclc, merkel cell carcinoma, head and neck squamous cell carcinoma, urothelial and renal cell carcinoma, cancers characterized by microsatellite instability, refractory hodgkin's lymphoma, hepatocellular carcinoma, gastric cancer. in addition, trials are underway to investigate the benefit of icis in other locations. thus, taking into account the growing importance of icis in the oncological therapeutic strategy and the large number of patients treated, a better understanding of the vascular impact of these drugs is necessary.


Eligibility criteria:
inclusion criteria: * signed informed consent. * patient over 18 years of age * patient with lung or head and neck cancer who should be treated with ici as a single agent according to the market indications, decision taken during a multidisciplinary consultation meeting * who 0 or 1 * patient affiliated to or benefiting from a social protection scheme. exclusion criteria: * indication for combined anti-pd-1 and chemotherapy (for patients with lung cancer) * history of radiotherapy treatment * history of chemotherapy or targeted therapy within the last 3 weeks * bilateral vascular carotid murmur * absence of sinus rhythm * presence of a pacemaker with permanent electrical stimulation * absence of peripheral carotid and/or femoral pulses on both sides * contraindication to the prescription of an ici * patient deprived of liberty by an administrative or judicial decision or patient placed under court protection, guardianship or curatorship * pregnant or breastfeeding woman

Keywords: immune checkpoint inhibitor head and neck cancer lung cancer
the effect of spironolactone on blood pressure in type-2 diabetics with resistant hypertension

Conditions: Arterial Hypertension; Hypertension, Resistant to Conventional Therapy; Diabetes Mellitus

Summary: the purpose of this study is to estimate the effect of spironolactone on blood pressure resistant to therapy in type-2 diabetics.

the primary object of the study is to estimate the effect of addition of low dose spironolactone to antihypertensive treatment with at least three antihypertensive drugs in patients with type-2 diabetes and blood pressure over 130/80 mmhg. secondary aims are to estimate how many of these patients have their blood pressure controlled by the addition of spironolactone, to investigate whether the addition of spironolactone affects insulin sensitivity and urinary protein secretion and to estimate the incidence of adverse effects of the aldosterone antagonist.

Eligibility criteria:
inclusion criteria: * age \< 75 years * type-2 diabetes * therapy resistant hypertension (by abpm) * treatment with at least 3 antihypertensives exclusion criteria: * hba1c \> 10.0 * bp \> 180/110 mmhg * secondary hypertension * intolerance to spironolactone * permanent treatment with nonsteroidal antiinflammatory drugs or systemic glucocorticoids * total cholesterol 10 mmol/l * new york heart association class iii and iv * pregnancy or planned pregnancy * psychiatric disease * malignant disease * insufficient adherence

Keywords: hypertension spironolactone antihypertensive treatment type-2 diabetes