Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of different doses of indacaterol in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic obstructive pulmonary disease (copd) (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease \[gold\] guidelines, 2008) and: 1. smoking history of at least 10 pack-years 2. post-bronchodilator forced expiratory volume in 1 second (fev1) \< 80% and ≥ 30% of the predicted normal value 3. post-bronchodilator fev1/fvc (forced vital capacity) \< 70% exclusion criteria: * patients who have had a copd exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * patients with a history of certain cardiovascular comorbid conditions other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: indacaterol copd salmeterol
a safety study of bms-852927 in subjects with hypercholesterolemia

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to evaluate the safety of bms-852927 after 28 days of dosing in patients with high cholesterol.


Eligibility criteria:
inclusion criteria: * men and women, aged ≥18 to ≤75 * body mass index (bmi) ≤ 40 kg/m2 * primary hypercholesterolemia on a stable daily dose of a statin for ≥ 6 weeks * serum triglyceride levels at screening \< 400mg/dl (\< 4.52 mmol/l) exclusion criteria: * any significant acute medical illness, significant cardiovascular history * current or history of hepatic or hepatobiliary disease * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations beyond what is consistent with the target population
comparative study of hoe490 o (glimepiride and metformin) compared with placebo on top of glimepiride

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective of this study is to confirm the efficacy of hoe490 o (glimepiride/metformin) compared with placebo on top of glimepiride in hba1c change. secondary objectives of this study is to evaluate the safety of hoe490 o (glimepiride/metformin) compared with placebo on top of glimepiride as well as other efficacy parameters

patients treated with 2-6mg/day of glimepiride will be recruited. the study period consists of screening phase of 6 weeks and double-blinded phase of 24 weeks.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus patients treated with constant dose of glimepiride on top of diet and exercise * patients who gave informed consent to participate in the study exclusion criteria: * patients with hba1c of \ 11.0 % * patients with any following laboratory test abnormality : * alt and/or ast: \> 3 x uln * neutrophils: \< 1,000/mm3 and/or platelets \< 100,000/mm3 * hemoglobin: \<11 g/dl * creatinine: \>= 1.3 mg/dl in case of male or \>= 1.0 mg/dl in case of female the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: glimepiride metformin combination drug therapy
pediatric anca associated-vasculitis

Conditions: ANCA-Associated Vasculitis

Summary: the incidence in pediatrics is very low (about 0.5 per million according to a french study) and therefore the data on the pathology very poor, especially on the therapeutic level. without appropriate treatment, the mortality rate of the pathology is very high. existing treatments are almost exclusively composed of immunomodulatory and/or immunosuppressive treatments. complications related to pathology and iatrogeny are among the first causes of mortality from this pathology and deserve to be studied in order to be known and if possible avoided. the purpose of the study is to achieve a national comparison of clinical and therapeutic practices.


Eligibility criteria:
inclusion criteria: * minor subject (\<18 years old) * diagnosis of anca vasculitis according to the international criteria for defining the pathology, gpa or mpa form between 2011 and 2020. * subject (and/or his parental authority) who has not expressed, after being informed, his opposition to the reuse of his data for the purposes of this research. exclusion criteria: * subject (or his parents) having expressed his (their) opposition to participating in the study * patients with vasculitis has anca in the form of egpa * associated pathologies that cannot be related to the diagnosis of anca vasculitis and whose prognosis can lead to biases in the efficacy and/or complications related to treatments.

Keywords: anca-associated vasculitis pediatric anca vasculitis
mechanisms and treatment of exercise intolerance and persistent fatigue in spinal muscular atrophy

Conditions: Spinal Muscular Atrophy

Summary: this study will focus on the pathophysiological underpinnings of reduced exercise capacity and fatigue in ambulatory patients with spinal muscular atrophy (sma). there has been laboratory evidence to suggest that the molecular mechanisms underlying mitochondrial biogenesis may be vulnerable to survival motor neuron (smn) protein deficiency. this is an observational, single visit study including 34 ambulatory sma patients treated with smn repletion therapies (risdiplam or nusinersen) for at least 6 months at enrollment.

smn depletion affects muscle mitochondria and thus muscle function as a result. the relationship between these and their effect(s) on fatigue in the context of smn repletion treatment has not been evaluated. if muscle function is vulnerable to smn insufficiency, treatment strategies targeting muscle in addition to the central nervous system (motor neurons) may ameliorate fatigue and improve exercise capacity, thereby improving quality of life and bringing sma treatments closer to a cure. this project explores such an idea by comparing the effects of the two different smn repletion modalities in patients. this is an observational cross-sectional study involving ambulatory sma children and adults treated for at least 6 months with smn repletion therapy, either (1) systemically with risdiplam, or (2) intrathecally (central nervous system-only), with nusinersen.

Eligibility criteria:
inclusion criteria: * genetic confirmation of sma with laboratory documentation of homozygous deletion of survival motor neuron (smn1) exon 7; * at least 8 years of age at time of signing informed consent form (or assent) * children or adults currently receiving treatment, for at least 6 months, with smn repletion therapy, either with (1) risdiplam, or (2) nusinersen * able to walk independently at least 25 meters * able to tread a stationary cycle ergometer. exclusion criteria: * unable to walk 25 meters independently. * use of investigational medications intended for the treatment of sma within 30 days prior to study entry. * the presence of any contraindication to exercise according the american college of sports medicine (acsm) criteria.

Keywords: spinal muscular atrophy neuromuscular disease risdiplam nusinersen aerobic capacity oxygen uptake fatigue near infrared spectroscopy muscle ultrasound exercise tolerance six minute walk test mitochondria mitophagy mitochondria exercise cycle ergometry sma
104ra204 assessment of the safety and efficacy of bg9924 in rheumatoid arthritis (ra) participants

Conditions: Rheumatoid Arthritis

Summary: to observe the long-term treatment with bg9924 when administered to participants with ra who previously participated in a biogen idec study.


Eligibility criteria:
inclusion criteria: * must be a participant from study 104ra202 (nct 00664716) * stable dose of methotrexate for the duration of the study exclusion criteria: * participants with a significant change in their medical history from their previous bg9924 study * any clinically significant infectious illness or serious local infection note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: safety rheumatoid arthritis baminercept alfa methotrexate bg9924 efficacy
efficacy of volume substitution and insulin therapy in severe sepsis (visep trial)

Conditions: Severe Sepsis; Septic Shock

Summary: the purpose of this trial is to determine the influence of colloid versus crystalloid volume resuscitation and of intensive vs conventional insulin therapy on morbidity and mortality of patients with severe sepsis and septic shock.

severe sepsis and septic shock have a high mortality. research has concentrated on adjunctive sepsis therapies; the role of supportive measures is comparatively unclear. in europe the use of colloids is widespread, but there is no evidence on the role of either crystalloid or colloid volume therapy in sepsis. recently, a higher incidence of kidney failure in sepsis was reported after administration of colloids. in critical illness, a significant reduction in mortality was recently achieved by strict glycemic control, however it has to be determined whether this is true and safe for patients with sepsis as well.

Eligibility criteria:
inclusion criteria: * patients fulfilling the criteria of "severe sepsis" or "septic shock" according to the society of critical care medicine/american college of chest physicians (sccm/accp) definitions not longer than 24 hours before icu admission or 12 hours after icu admission exclusion criteria: * age \< 18 years * pregnancy * known allergy against hydroxyethyl starch * pre-treatment with \> 1000ml hydroxyethyl starch within 24 hours before inclusion * pre-existing kidney failure requiring dialysis or serum creatinine value \> 320 mmol/l (3,6 mg/dl) * intracerebral hemorrhage * severe head trauma with edema * fio2 at time of study inclusion \> 0,7 * heart failure (new york heart association \[nyha\] iv) * enrolment in another interventional study * immune suppression (cytostatic chemotherapy, steroid therapy, aids) * do not resuscitate (dnr) order

Keywords: severe sepsis septic shock volume substitution intensive insulin therapy colloids crystalloids outcome safety
cognitive-behavioral therapy for young adult lesbian, gay and bisexual: transdiagnostic minority stress approach

Conditions: Depression, Anxiety; Alcohol Abuse; Sexual Compulsivity; Unsafe Sex

Summary: background: lgb people experience a large number of anxiety and mood disorders, and risk behaviors than heterosexual (marshall et al., 2011). the evidence points to the importance played by the stress of minorities in the development of such problems (bränstrom, hatzenbuehler, pachankis and link, 2016). objective: the present study aims to adapt and analyze the efficacy of the esteem program designed for this population (burton, wang and pachankis, in press) in: 1) the reduction of psychopathological symptoms, abusive alcohol consumption and risky sexual behavior, 2 ) the decrease in the level of stress, anxiety for rejection, internalized homophobia and level of concealment, and finally, 3) the improvement of assertiveness levels. the effect of the variables social support, emotional regulation strategies and rumination will be analyzed. method: a quasi-experimental design will be used, where the lgb people (n = 63, 18\<) will be assigned to the experimental group (immediate treatment), or to the control group (three-month waitlist). at baseline, 3-month, 6-month and 12-month assessments, participants completed self-reports of mental health and minority stress. results: it is expected that after treatment, lgb people mental health will be improved, as well as, minority stress will be reduced.


Eligibility criteria:
inclusion criteria: 1. being born male and currently identifying as a man; or being born female and currentry identifying as a female 2. gay, lesbian or bisexual identity 3. minimum age 18 exclusion criteria: 1. not currently receiving regular mental health services 2. not having and addictive disorder

Keywords: minority stress lgb stigma cognitive behavioral therapy (cbt)
safety and efficacy study of opc-415 in patients with relapsed and/or refractory multiple myeloma

Conditions: Multiple Myeloma (MM)

Summary: the purpose of this study is to evaluate the tolerability,safety and efficacy of opc-415 in patients with relapsed and/or refractory multiple myeloma (mm).


Eligibility criteria:
inclusion criteria: * patients aged between 20 and 80 (75 for the phase 1 part) years, both inclusive, at the time of consent * patients with a definitive diagnosis of active multiple myeloma * patients who have had 2 or more prior regimens (including all proteasome inhibitors, immunomodulators, and anti-cd38 antibody) * patients with relapsed and/or refractory multiple myeloma * patients who are positive for mmg49 antigen * patients with an eastern cooperative oncology group (ecog) performance status (ps) score of 0 or 1. those with an ecog-ps score of 2 due solely to mm bone lesions can be enrolled * patients who are expected to survive for at least 3 months exclusion criteria: * patients who are scheduled to receive high-dose chemotherapy in combination with autologous stem cell transplantation as the next treatment. * patients who have other active double/multiple cancers * patients on continuous and systemic (oral or intravenous) medication with corticosteroids or other immunosuppressive agents * patients with graft-versus-host disease that requires treatment. * patients who underwent a highly invasive and extensive surgical procedure within 2 weeks. * patients who previously underwent allogeneic stem cell transplantation or organ transplantation. * patients who underwent autologous stem cell transplantation within 90 days. * patients with systemic amyloidosis (except localized amyloidosis without organ derangement) or plasma cell leukemia. * patients with prior or current central nerve involvement in mm. * patients whose best ever response to mm treatment is pd. * patients who previously received gene therapy or cell therapy (except hematopoietic stem cell transplantation). * pregnant women, nursing mothers, or women with a positive pregnancy test.
cgf influence on post-operative complications.

Conditions: CGF; Bone Loss; Post-operative Wound Healing

Summary: the aim of the study is to evaluate the influence of cgf application into post-operative soft tissue and bone defects on post-operative complications and wound healing.

the research was conducted in twenty patients with symmetric single tooth qualified to extraction. on one side of dental arch, post-operative region was field with cgf material, while on the other side it was left to normal healing. in both cases pain, swelling, alveolar osteitis, antibiotics and analgesics intake in post-operative period were evaluated in the first, fourth and seventh day after surgery. wound healing was assessed seven and thirty days after extraction.

Eligibility criteria:
inclusion criteria: * no known medical history of abnormal platelet counts, * patients with symmetric teeth qualified for extraction, exclusion criteria: * systemic diseases, * pregnancy, * lactation, * drugs known to affect the number or function of platelets, * abnormal platelet counts
growth hormone signaling in vivo in humans

Conditions: Intracellular Signaling Peptides and Proteins

Summary: objective: gh induces insulin resistance in muscle and fat and in vitro data indicate that this may involve crosstalk between the signaling pathways of the two hormones. aim: to investigate gh and insulin signaling in vivo in human muscle and fat tissue in response to gh, gh receptor blockade and insulin stimulation..

the molecular mechanisms by which gh promotes insulin antagonism are still unclear. stimulation of lipolysis could be of importance since high plasma ffa levels have been shown to interfere with insulin receptor signaling via inhibition of insulin-stimulated insulin receptor substrate (irs)-1 associated phosphatidylinositol (pi) 3-kinase activity in human skeletal muscle, resulting in a decreased glut4 translocation and glucose transport (6). a recent study, however, was unable to document a suppression in the insulin-stimulated activity of either irs-1 associated pi 3-kinase or the serin/threonin kinase akt after gh administration to healthy humans, despite induction of lipolysis and insulin resistance (7). other studies have shown that acute gh exposure induces insulin resistance in skeletal muscle rapidly and before the subsequent rise in plasma ffa (1;7;8). these observations indicate that gh may cause insulin resistance via a non-ffa mediated mechanism. the predominant gh signal transduction cascade comprises activation of the ghr dimer, phosphorylation of jak2 and subsequently activation of stat5. the intact jak2/stat5 pathway is necessary for normal statural growth (9). there is animal and in vitro evidence to suggest that insulin and gh share post-receptor signaling pathways (10). convergence has been reported at the levels of stat5 and socs3 as well as on protein kinases comprising the major ir signaling pathway; irs 1/2, pi 3-kinase, akt and erk 1/2 (11-14). pegvisomant is a gh analog and a competitive reversible gh receptor antagonist, which blocks peripheral gh signal transduction (15). pegvisomant has been shown to inhibit the necessary conformational change of the ghr dimer and thus constitutes an optimal negative control in gh signaling studies. the aim of this work was to further study gh signal transduction pathways in vivo in muscle and adipose tissue from healthy subjects in response to acute and more prolonged gh exposure as well as during hyperinsulinemia. the design also included administration of pegvisomant in an attempt to correct for spontaneous gh secretion.

Eligibility criteria:
inclusion criteria: * male * healthy * not taking medication exclusion criteria: * insulin resistance

Keywords: gh, gh receptor blockade, gh signaling, insulin resistance
prospective biobanking study in cancer patients aiming at better understand the link between the molecular alterations of the tumor itself, its microenvironment and immune response (scandare)

Conditions: Ovarian Cancer; Triple-Negative Breast Cancer; Head and Neck Cancer; Cervical Cancer; Sarcoma

Summary: scandare is a prospective biobanking study on tumor (+/- nodes), plasma and blood samples at different time points in ovarian, triple negative breast, head and neck cancer, advanced stage treatment-naïve cervical cancer and sarcoma (breast angiosarcoma and uterine sarcoma) cancers. this study will allowed to identify new molecular and/or immunological biomarkers associated with clinical and biological features of the tumors. all patients will receive standard treatment according to the stage of the diseases and usual procédures.

patients will have blood and +/- tumor samples at the following times : 1. if eligible for surgery : * at surgery (blood + tumor and nodes) * after surgery (blood) * 6 months after surgery if non recurrence (blood) * before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes if possible) * before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood) * at progression (blood + tumor biopsie and nodes if possible) 2. if eligible for neoadjuvant chemotherapy : * before neoadjuvant therapy (blood + tumor biopsie and nodes) * during neoadjuvant therapy (post cycle 1) (blood) * at the time of surgery (blood + tumor and nodes) * 6 months after surgery if non recurrence (blood) * before cycle 1 of adjuvant chemotherapy or before radiotherapy (blood + tumor biopsie and nodes) * before cycle 2 of adjuvant chemotherapy or after radiotherapy (blood) * at progression (blood + tumor biopsie and nodes)

Eligibility criteria:
inclusion criteria: 1. tumor types : 1. newly diagnosed treatment-naïve ovarian cancer patients eligible for surgery or neoadjuvant chemotherapy 2. newly diagnosed treatment-naïve triple-negative breast cancer patients eligible for surgery or neoadjuvant chemotherapy 3. newly diagnosed treatment-naïve head and neck cancer patients eligible for surgery 4. newly diagnosed treatment-naïve cervical cancer patients (1) stage ia - iia1 with nodal metastasis, postoperative positive margin or parametrial-vaginal involvement, and (2) stage ≥iia2). 5. newly diagnosed treatment-naïve sarcoma cancer patients (1) breast angiosarcoma or (2) uterine sarcoma eligible for surgery or systemic treatment 2. male or female patients ≥ 18 years of age 3. signed informed consent exclusion criteria: 1. male or female patients ≤18 years old 2. patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 3. individually deprived of liberty or placed under the authority of a tutor 4. patients not affiliated to the social security system

Keywords: immunological biomarkers molecular profil circulating tumor dna (ctdna)
a longitudinal study to investigate and develop a patient-centered and effective fatigue screening

Conditions: Cancer-related Fatigue

Summary: merlin will include 300 cancer patients at the beginning of their systemic cancer therapy. patients' fatigue-levels will be surveyed at short time intervals during their cancer therapy and at longer intervals during the subsequent post-treatment phase.

merlin aims to answer the question, how a fatigue screening tool should be designed for use in clinical practice to reliably and efficiently detect fatigue in cancer patients. patients will be surveyed at short time intervals during their cancer therapy (every 1-2 weeks) and at longer intervals during the subsequent post-treatment phase (every 4-6 weeks). in addition, important psychological factors, which may exacerbate fatigue or contribute to its maintenance will be assessed at baseline, after 3, 6, 12 and 18 months (e.g. depressive symptoms, anxiety, sleep disturbances, coping). these data will be collected by online questionnaires. additional data, e.g. medical history, cancer characteristics and treatment as well as concomitant medication and complementary therapies will be extracted from the clinical documentation systems. in total, the study will provide important information for the establishment of a patient-oriented fatigue screening. thus, merlin will contribute to the early detection and alleviation of this frequent and distressing side effect of cancer treatment.

Eligibility criteria:
inclusion criteria: * having received a cancer diagnosis (any entity, any stage) * before or within the first month of systemic therapy or radiotherapy against this cancer * age ≥ 18 years * having the ability to consent to the study exclusion criteria: * previous systemic cancer therapies or radiotherapy within the last 6 months * diagnosis of chronic fatigue syndrome / myeloid encephalitis * unable to understand the study protocol and complete scheduled assessments during the study period (e.g., for language, cognitive, medical, or organizational reasons) * not able to complete the survey online via smartphone, pc, or tablet