Kornimate/medical-research-clean huggingface dataset:
a study to assess the safety, tolerability, and efficacy of ionis-ghr-lrx administered in patients with acromegaly

Conditions: Acromegaly

Summary: the purpose of this study was to determine the safety, tolerability, and efficacy of ionis-ghr-lrx subcutaneous (sc) injection as monotherapy in patients with acromegaly.

this was a multi-center, open-label, randomized, phase 2 study of ionis-ghr-lrx in up to 40 participants with acromegaly. participants were randomized to 1 of 2 treatment groups to receive ionis ghr-lrx monthly for 73 weeks. at the end of 73 weeks, participants entered a 14-week post-treatment (pt) evaluation period.

Eligibility criteria:
inclusion criteria: 1. males or females with a documented diagnosis of acromegaly\* who are 18 to 75 years old (inclusive) at the time of informed consent. 2. have had pituitary surgery (e.g. transsphenoidal) unless there was a contraindication to surgery and are either acromegaly medical treatment naïve, or who had not taken any other acromegaly medications prior to the screening visit as outlined below * bromocriptine: 2 weeks * cabergoline: 4 weeks * quinagolide: 4 weeks * octreotide daily injection (sc) or oral formulation: 4 weeks * pegvisomant: 4 weeks * octreotide lar: 3 months * pasireotide lar: 4 months * lanreotide (all formulations): 3 months 3. at screening, serum igf-1 (performed at the central lab) between 1.3 to 5 × uln, inclusive, adjusted for age and sex. 4. females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, abstinent, or using 1 highly effective method of birth control exclusion criteria: 1. participants who received surgery for pituitary adenoma within the last 3 months before the trial, and/or planning to receive surgery during the trial 2. participants who received radiotherapy for pituitary adenoma within the last 2 years before the trial, and/or planning to receive radiotherapy during the trial 3. participants with a pituitary tumor that, per investigator judgment, is worsening (e.g., either growing or at risk of compressing or abutting the optic chiasm or other vital structures) as assessed by pituitary/sellar mri protocol at screening or within 3 months of screening. ct scan is allowed if mri is contraindicated 4. evidence of decompensated cardiac function per medical judgement and/or new york heart association (nyha) class 3 or 4 5. clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment 6. symptomatic cholelithiasis, and/or choledocholithiasis

Keywords: acromegaly ionis-ghr-lrx
transoral endoscopic thyroidectomy by vestibular approach (toetva)

Conditions: Thyroid Diseases; Thyroid Cancer

Summary: prospective study carried out with icesp (instituto do câncer do estado de são paulo) patients with thyroid disease with surgical indication

prospective study carried out with icesp patients with thyroid disease with surgical indication, according to the aforementioned inclusion criteria, totaling 60 cases, which will be randomized into two groups: * conventional thyroidectomy (30 patients) * transoral endoscopic thyroidectomy by vestibular approach (30 patients)

Eligibility criteria:
inclusion criteria: * history of hypertrophic scarring and/or motivation to avoid cervical scarring, * maximum diameter of the thyroid \< 10 cm and of the dominant nodule \< 6 cm, * estimated thyroid volume \< 45 ml * benign lesion (multinodular goiter, cyst), * indeterminate nodule (bethesda iii or iv), * suspicious nodule for well-differentiated thyroid carcinoma (bethesda v and vi) \< 2 cm exclusion criteria: * history of previous surgery or irradiation in the head and neck region and superior mediastinum * evidence of clinical hyperthyroidism * preoperative recurrent nerve palsy * lymph node metastasis * extra-thyroid extension * plunging goiter * oral abscess
effect of immunonutrition on inflamatory markers after bariatric surgery

Conditions: Postoperative Complications

Summary: a prospective randomized clinical trial of all the patients undergoing roux - en-y gastric bypass will be performed. patients will be randomly assigned into 2 groups: those patients receiving a preoperative balanced energy high-protein formula (group 1) and those receiving preoperative immunonutrition (group 2). changes between groups in acute inflamatory markers, pain, postoperative septic complications and lenght of stay, among others will be investigated.

a prospective randomized clinical trial of all the patients undergoing roux - en-y gastric bypass will be performed. patients will be randomly assigned into 2 groups: those patients receiving a preoperative balanced energy high-protein formula (group 1) and those receiving preoperative immunonutrition (group 2). changes between groups in acute inflamatory markers (crp, fibrinogen, leucocites), pain (vas scale), postoperative septic complications .(anastomotic leak and organ/space ssi)and lenght of stay, among others will be investigated.

Eligibility criteria:
inclusion criteria: 1. patients undergoing a laparoscopic gastric bypass (bpg) as a bariatric procedure 2. men and women older than 18 years. 3. willing to participate in the study and giving their written consent exclusion criteria: 1. patients younger than 18 years. 2. patients undergoing other bariatric surgery techniques. 3. patients undergoing any other surgical procedure added to the bariatric technique. 4. patients with medical or surgical pathologies that at the discretion of the investigator do not allow their participation in the study. 5. inability to understand the nature and purpose of the study and / or to accept written participation in the study. 6. impossibility to comply with pre-established clinical follow-up.
study of single dose ghb16l2 trivalent influenza vaccine in healthy adults

Conditions: Influenza, Human

Summary: the purpose of this phase i/ii trial is to evaluate safety and tolerability of a single dose of ghb16l2 administered by liquid nasal spray for vaccination against seasonal influenza virus infection. it is also performed to assess immunogenicity and pharmacokinetics (shedding).

ghb16l2 intends to provide a novel vaccination for influenza virus infection. 80 healthy volunteers will be included at a ratio of 1:1 for ghb16l2 or placebo. ghb16l2 will be administered once on day 1. follow-up visits will be performed on days 2, 8 and 29.

Eligibility criteria:
inclusion criteria: * healthy male and female volunteers, 18-60 years * seronegative for one or two of the applied vaccine strains * low antibody titres for h1n1v * written informed consent to participate in this study * for female volunteers of childbearing potential, provision of a history and current use of reliable contraceptive practices exclusion criteria: * acute febrile illness (\>37.3°c) * signs of acute or chronic upper or lower tract respiratory illnesses * history of severe atopy * seasonal influenza vaccination in 2008/2009 and/or later seasons and/or pandemic influenza vaccination at any time * fever ≥38.0°c in the time period between the pre-screening visit and day 1 * known increased tendency of nose bleeding * volunteers with clinically relevant abnormal paranasal anatomy * volunteers with clinically relevant abnormal laboratory values * in female volunteers of childbearing potential, a positive urine pregnancy test * simultaneous treatment with immunosuppressive drugs incl. corticosteroids (≥2 weeks) within 4 weeks prior to study medication application * clinically relevant history of renal, hepatic, gi, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases * history of leukaemia or cancer * hiv or hepatitis b or c seropositivity * volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication * volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within 4 weeks prior to study medication application * volunteers who have received anti-inflammatory drugs 2 days prior to study medication application * volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study

Keywords: live attenuated flu vaccines influenza a (h1n1) intranasal application replication-deficient influenza virus
autologous immune cell therapy in primary hepatocellular carcinoma patients following resection and tace therapy

Conditions: Primary Hepatocellular Carcinoma

Summary: although liver resection, liver transplantation, a-interferon, transarterial chemo embolization (tace), percutaneous ethanol injection (pei), percutaneous microwave coagulation therapy (pmct), radiofrequency ablation (rfa) provide options to treat patients with hcc, the high recurrence rate of mid-late stage liver cancer still exists. the safety of autologous immune cell therapy in primary hepatocellular carcinoma (hcc) patients following resection and tace therapy will be evaluated.

the study is a single center,open label trial. to obtain safety information on toxicities and adverse events attributable to the subcutaneous injections of autologous dendritic cells incubated with irradiated autologous tumor stem cells and suspended in gm-csf in patients with hcc.

Eligibility criteria:
inclusion criteria: 1. voluntary written informed consent signed by patient or legal guardian, obtained prior to study enrollment. 2. bclc classification a-b 3. patients who are good surgical candidates for hcc resection 4. ecog performance score, 0-1 5. child-pugh rating, a 6. expected survival greater than 6 months exclusion criteria: 1. history of anaphylactic reaction to gm-csf 2. congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation 3. mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process 4. primary cancers of any kind or location, other than hepatocellular carcinoma 5. excluding hepatitis, any active or unresolved infection including hiv, ebv, cmv, rpr, tb, etc. 6. autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy. 7. prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment. 8. pregnant or lactating women. 9. patients with the intention to receive transplantation 10. significant comorbidity or other active medical condition that could be eminently life threatening in the opinion of the investigator, including no active blood clotting or bleeding diathesis. 11. evidence of metastatic disease.

Keywords: dc immunotherapy tc
study of combination therapy with syr-322

Conditions: Diabetes Mellitus

Summary: to determine the efficacy and safety of syr-322 (alogliptin) 25-mg, once daily (qd), in patients with diabetes when used in combination with insulin.


Eligibility criteria:
inclusion criteria: 1. the subject is an outpatient. 2. the subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. exclusion criteria: 1. the subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease. 2. the subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.
impact of the change in hospital service of caregivers during covid-19 health crisis on operational strain

Conditions: Burnout, Caregiver

Summary: the french armed forces health service caregivers are confronted with specific operational constraints that require physiological adaptation on a daily basis. these constraints generate an allostatic load resulting from the body's adaptation to the environment through stress response systems. the covid-19 health crisis has modified the physical and psychological constraints linked to usual activity, in particular by imposing versatility to caregivers. the research hypothesis is that carers who have undergone activity reorganisations, and in particular a change of service, are more affected by the health crisis than those who have remained in their service and have continued an activity close to their usual practice.


Eligibility criteria:
inclusion criteria: * to be caregivers * have been in employment between march 15 and may 15, 2020 exclusion criteria: * none
mind body intervention for chronic upper extremity pain (repetitive stress injury)

Conditions: Chronic Pain; Chronic Pain Syndrome; Repetitive Stress Injury

Summary: the goal of this nonrandomized pilot study is to test a mind-body interventional approach for the treatment of chronic upper extremity pain or repetitive stress injury of the upper extremity (wrist/shoulder/elbow). 1. to determine if a mind-body intervention improves upper extremity functional capacity (ie., disability of arm shoulder hand - dash) among people with chronic wrist, elbow, and shoulder pain 2. to determine if a mind-body intervention decreases pain intensity, pain-related anxiety, and overall somatic complaints in our trial participants. 3. to tailor the intervention and the outcomes assessment procedures for conducting a trial in a population with upper extremity pain.


Eligibility criteria:
inclusion criteria: 1. adult (≥ 18 years of age) 2. a disability score ≥ 40 as per the quickdash survey 3. presence of pain and perceived disability for a minimum of 3 months 4. willing to engage in a mind-body intervention 5. positive visualization test (onset of pain when patients visualize themselves performing tasks that generally bring on pain) exclusion criteria: 1. clear organic diagnosis of pain (e.g., cancer, infection, etc...) not inclusive of non-specific findings on imaging studies (e.g., mild arthritis) 2. age greater than 60 years (due to an increased risk of there being an organic/physical cause for their pain and confounding results) 3. diagnosis of cognitive impairment or dementia 4. active addiction disorder, e.g. cocaine or iv heroin use, that would interfere with study participation 5. major psychiatric comorbidity (e.g., schizophrenia). anxiety and mild-moderate depression are not considered in this category
multidisciplinary follow-up of patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: analyse a multidisciplinary follow-up of amyotrophic lateral sclerosis patients, monitored through a cohort study at geneva university hospitals.

since april 2010 a quarterly follow-up is available for patients with als at geneva university hospitals. it takes place in the outpatient unit of the department of neurology, and includes interventions by the multidisciplinary team of the " center for amyotrophic lateral sclerosis and related diseases ". this new tracking method can help improving quality of life of patients and their families by adapting medical care, proposing communication aids, facilitating access to specialized examinations and anticipating pulmonary, nutritional and neurologic complications. moreover, it speeds up administrative procedures, improves the flow of information between medical teams inside and outside the hospital and it allows and encourages discussion about advanced directives. since june 2012, the multidisciplinary follow-up is monitored through a cohort study that was approved by the ethical committee (nac 11-062r). we collect clinical examination findings, anthropometric evaluation, blood analyses, pulmonary function tests, respiratory muscle strength, arterial blood gases, nocturnal oximetry, and evaluation by occupational therapists and by physiotherapists on a quarterly basis. nerve conduction studies are done at the beginning of the follow-up to identify the degree and extent of loss of upper and lower motoneurons in als and to help guiding the diagnosis. mri and analysis of cerebrospinal fluid are also acquired at the beginning of the follow-up in order to rule out other diagnoses which can mimic als. definite, probable or possible als is defined according to the revised el escorial and awaji criteria \[16-17\]. patients are referred to a genetic counselor who helps making informed decisions regarding genetic issues. the data collected are inserted into the secu-trial database, which is managed by an assistant provided by the clinical research center.

Eligibility criteria:
inclusion criteria: amyotrophic lateral sclerosis fulfilling the el escorial criteria (definite, probable, possible), primary lateral sclerosis, progressive muscular atrophy, progressive bulbar palsy exclusion criteria: patients with other neurological diagnoses than mentioned in the inclusion criteria
acupuncture-tdcs convergence rehabilitation effect on stroke patients

Conditions: Stroke, Acute

Summary: the purpose of this study is to confirm the convergence effectiveness of on acupuncture of the chinese medicine and the tdcs of the western medicine on motor function for patients with acute stroke compared to the control group.


Eligibility criteria:
inclusion criteria: * those who within 2 weeks or more and 6 months after a stroke diagnosis. * those who have a lesion with a cortex or subcortex * adults over 19 years old * inpatients and outpatients who can mediate for 4 weeks * those who can understand and follow the purpose of this study exclusion criteria: * those who fall under the exclusion criteria for electrical acupuncture or acupuncture or tdcs * those who have a experience about adverse reaction to the existing electrical acupuncture or acupuncture or tdcs * those who have major psychiatric diseases such as major depression disorders, schizophrenia, bipolar disorders, and dementia * a person who judges that it is not appropriate for a researcher to participate in this study
application of ultrasonic gray-scale ratio in differentiating benign from malignant thyroid nodules.

Conditions: Thyroid Nodule

Summary: according to the grades of echogenicity to evulated thyroid nodules is a subjective process and is thus influenced by the observer's judgement. the investigators first proposed the ultrasound gray-scale ratio (ugsr) to explore its efficacy for differentiating papillary thyroid microcarcinomas from small nodular goiters.

echogenicity is a common ultrasonic parameter to evaluate thyroid nodules. the echogenicity of the thyroid nodule was divided into 5 grades according to gray scale. of the five categories, the diagnostic values of the hypoechoic and markedly hypoechoic categories have been widely accepted for thyroid malignant nodules. however, distinguishing between hypoechoic and markedly hypoechoic categories is a subjective process and is thus influenced by the observer's judgement. a more objective method should be proposed to differentiate papillary thyroid microcarcinoma(ptmc) from small nodular goiter(ng). the investigators suspect the echo intensity of nodules could be reflected by values, as ct values reflecting the nodule density. the investigators first proposed the ultrasound gray-scale ratio (ugsr), namely, the ratio of lesion gray-scale value to surrounding normal thyroid tissue, and the previous study showed ugsr can better display the relationship of gray scale of ptmc or ng with surrounding normal thyroid tissue, and can make objective judgment of the nodules through quantitative results. as the absolute ultrasound grayscale value is affected by the apparatus, scan gain, dynamic range, frequency, and operators. the investigators would collected different data acquired from different parameters to explore their potential relations.

Eligibility criteria:
inclusion criteria: * patients diagnosed as thyroid nodule. * homo-echogenicity of normal thyroid tissue. * able and willing to comply with all study requirements. exclusion criteria: * nodules are mainly cystic or calcified. * pathology confirmed hashimoto's thyroiditis. * unable or unwilling to comply with all study requirements.

Keywords: thyroid nodule differential diagnosis
study of wve-004 in patients with c9orf72-associated amyotrophic lateral sclerosis (als) or frontotemporal dementia (ftd)

Conditions: ALS; FTD

Summary: this is a phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pk, and pd of intrathecal (it) wve-004 in adult patients with c9orf72-associated als or ftd. to participate in the study, patients must have a documented mutation (ggggcc \[g4c2\] repeat expansion) in the first intronic region of the c9orf72 gene and be diagnosed with als or ftd.


Eligibility criteria:
inclusion criteria: 1. als-specific: diagnosis of als based on clinical manifestations. 2. als-specific: clinically diagnosed possible, laboratory supported probable, probable, or definite criteria for diagnosing als according to the world federation of neurology revised el escorial criteria. 3. als-specific: patients receiving riluzole have been on a stable dose for a minimum of 30 days. 4. als-specific: patients on edaravone have received a minimum of 1 cycle (28 days). 5. als-specific: patients discontinuing riluzole or edaravone had the last dose administered ≥1 month prior to screening. 6. ftd-specific: must have global clinical dementia rating - frontotemporal lobar degeneration (cdr® plus nacc ftld) score of 0.5 or 1. 7. ftd-specific: able to undergo periodic magnetic resonance imaging (mri) of the brain. participants with mixed phenotype (als and ftd) need not undergo mri if their als symptoms prevent it. 8. mixed-phenotype: patients who are mixed phenotype (als and ftd) must meet both the als-specific and ftd-specific criteria. exclusion criteria: 1. clinically significant medical finding on the physical examination other than c9orf72-associated als or ftd that, in the judgment of the investigator, will make the patient unsuitable for participation in, and/or completion of the trial procedures 2. received any other investigational drug, biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer. received an investigational oligonucleotide, within the past 6 months or 5 half-lives of the drug, whichever is longer.
stress level and the relationship with ivf outcomes.

Conditions: Infertility

Summary: the effect of stress on ivf outcomes.

the purpose of this study is to describe the pattern of psychological distress (depression, anxiety and stress) as assessed by both subjective and objective measures throughout the course of ivf treatment and to investigate its impact on ivf outcome.

Eligibility criteria:
inclusion criteria: * healthy women undergoing ivf at crmi ages 20-44 patients will be divided in different groups depending on whether: 1. they are donating oocytes (control group). 2. they are undergoing ivf for the first time. 3. they are undergoing ivf for the third time and have either failed or succeeded the prior time. exclusion criteria: * any patients who are not candidates for ivf * any women who have any past or current medical condition unrelated to their infertility concurrent to their history of infertility (e.g., gastrointestinal disease)
quality assessment in acute stroke care

Conditions: Acute Ischemic Stroke

Summary: the purpose of the study is to evaluate the quality of care on a 16 bed stroke unit by using a new developed clinical pathway.


Eligibility criteria:
inclusion criteria: * admission to the stroke unit of the university hospital in muenster, germany * acute ischemic stroke or transient ischemic attack exclusion criteria: * intracerebral haemorrhage * neurological symptoms due to other pathology than acute ischemic stroke or transient ischemic attack * intraarterial thrombolysis * necessity of artificial ventilation

Keywords: acute ischemic stroke clinical pathway quality of care secondary prevention