Kornimate/medical-research-clean huggingface dataset:
adhd - voice analysis, vocal acoustic biomarkers in attention deficit hyperactivity disorder

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: the purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (adhd) patients.

this project aims to develop an objective diagnostic instrument for adhd through an automatic voice-analysis system, which uses as input the natural speech of the participants. the underlying voice-analysis procedure was developed by j. langner at humboldt university of berlin (langner 2003). it ignores the semantic content of spoken words and extracts prosodic and sound features from the speech. aims of the study: * deliver optimized multivariate logistic regression models of prosodic and sound properties of speech for adhd. * observe sensitivity and specificity of the voice-analysis procedure.

Eligibility criteria:
inclusion criteria: 1. age 18-50. 2. written informed consent. 3. adult adhd / non-adhd according to the fourth version of the diagnostic and statistical manual for mental disorders (dsm-iv) 4. normal vocal functioning, negative history for voice or laryngeal disorders. 5. currently euthyroid condition; in case of past history of thyroid disease and need for current pharmacological treatment, patient needs to be on stable medication for at least 4 weeks. exclusion criteria: 1. exclusion of borderline and antisocial personality disorder, assessed by the german version of the scid-ii (fydrich et al., 1997). 2. exclusion of schizophrenia and psychotic disorders not otherwise specified. 3. exclusion of epilepsia.

Keywords: adhd
immunogenicity of seasonal influenza by delivery directly to ileum

Conditions: Seasonal Influenza

Summary: the purpose of the study is to determine the safety and tolerability of vxa-a1.1, an adjuvanted adenoviral based influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. the secondary objective is to evaluate the immune response (cellular and humoral) of two doses of vxa-a1.1 oral vaccine.


Eligibility criteria:
inclusion criteria: * able and willing to complete informed consent * healthy, as established by medical history, physical exam, and laboratory assessments * has normal bowel movements * willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after discharge exclusion criteria: * not able to donate up to 550 ml of blood over several months * exposure to an investigational drug or vaccine 8 weeks prior to study * abnormal ecg findings * history of irritable bowl or any other inflammatory gastrointestinal disorder * any individual with increased risk for bowl obstruction * radiation exposure above target values 50 msv within the past 30 days or a cumulative dose above 150 msv in the past 12 months * history of substance abuse * subject unwilling to use an approved method of contraception during study and for 2 months after study * positive for hcv, hiv, or hbv * presence of implantable device that is sensitive to radio frequencies ( e.g. pacemakers) * history of autoimmune disorder, or an immunosuppressive disorder * stool sample with occult blood at baseline * any other medical, psychiatric, social condition, or occupation, in the judgement of the investigator is a contraindication to the compliance of the protocol or informed consent

Keywords: prevention of influenza
effect of solar salt diet in elderly hypertensive patients

Conditions: Hypertension

Summary: high sodium intake causes hypertension. various efforts for reducing salt consumption are proceeding all over the world. solar salt contains reduced sodium and abundant mineral, such as calcium, potassium, and magnesium, comparing to ordinary salt. use of solar salt, instead of ordinary salt, may have beneficial effects to blood pressure. the investigators are going to conduct a preliminary study that can support antihypertensive effect of solar salt intake.


Eligibility criteria:
inclusion criteria: * above 50 years elderly hypertensive patients * possible oral intake exclusion criteria: * dementia, gds\>6 * terminal cancer patient
does antidepressant use blunt adaptations to exercise?

Conditions: Depression; Depressive Disorder; Metabolic Syndrome

Summary: nearly one out of ten us adults over the age of 18 currently takes antidepressant medication, which can also treat other conditions such as anxiety. combining pharmaceutical treatment with exercise may yield even greater benefits than using drugs alone, and this is commonly prescribed for depression. however, little is known about the drug-exercise interactions and their influence on metabolic health. a common side effect of antidepressant use is weight gain, particularly abdominal (visceral) fat, which is highly detrimental to overall health. exercise is a well-known counter to abdominal fat accumulation. the aim of the proposed study is to compare the efficacy of 6 weeks of exercise training to reduce abdominal fat in healthy overweight/obese adults either taking or not taking antidepressant medication. twenty-four inactive overweight/obese, but otherwise healthy, adults will complete 6 weeks of an exercise training intervention consisting of three days of aerobic exercise training per week. participants will either not be taking antidepressant medication or will have been on their medication for at least 1 year. the primary outcome will be abdominal fat determined by waist circumference and dual x-ray absorptiometry, which is considered one of the optimal methods for assessment of abdominal fat.


Eligibility criteria:
inclusion criteria: * participants will be english language speakers * male or females between the ages of 18-40. * all genders and ethnicities. * healthy as assessed by a health history questionnaire (no diagnosed physical diseases or conditions preventing participation in exercise). * individuals on antidepressants will be recruited if they are consuming selective serotonin reuptake inhibitors (ssris) and selective serotonin and norepinephrine reuptake inhibitors (snris) only. participants will send prescription information after consent has been provided as part of the screening process, including the dose and frequency of medication. * a body mass index (bmi) of 25 or greater is required for inclusion. exclusion criteria: * inability to complete moderate-vigorous exercise. * taking first generation antidepressant medications or other medications such as monoamine oxidase inhibitors (maoi). * other medications, such as medications for attention-deficit hyper-activity disorder or metabolism * undiagnosed depression that may be unveiled during the screening process.

Keywords: exercise antidepressants visceral fat
patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy

Conditions: Metastatic Colorectal Cancer

Summary: this is a randomized, double-blind, placebo-controlled multi-center phase iii study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (crc) who have progressed on/after all approved drugs for crc

all participants received best supportive care. acronyms used in adverse events section: gastrointestinal (gi), genitourinary (gu), not otherwise specified (nos), absolute neutrophil count (anc), aspartate aminotransferase (ast), alanine aminotransferase (alt), common terminology criteria for adverse events (ctcae), international normalized ratio (inr), central nervous system (cns), acute respiratory distress syndrome (ards), cranial nerves (cn), disseminated intravascular coagulation (dic), cardiac troponin t (ctnt). abbreviation used in results section: data monitoring committee (dmc). adverse event collection will be covered in adverse events section.

Eligibility criteria:
inclusion criteria: * histological or cytological documentation of adenocarcinoma of the colon or rectum * progression during or within 3 months following the last administration of approved standard therapies. patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy * patients with measurable or non measurable disease * eastern cooperative oncology group (ecog) performance status of \</= 1 * life expectancy of at least 3 months * adequate bone marrow, liver and renal function exclusion criteria: * unstable/uncontrolled cardiac disease * history of arterial or venous thrombotic or embolic events * symptomatic metastatic brain or meningeal tumors * patients with evidence or history of bleeding diathesis * interstitial lung disease - persistent proteinuria \>/= grade 3 * unresolved toxicity \> grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity \</= grade 2

Keywords: metastatic colorectal cancer
a chart review study of adults with advanced nsclc

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the main aim is to see how treatment patterns and drugs might improve care for adults with advanced or metastatic nsclc with epidermal growth factor receptor (egfr) exon-20 driven mutations. past medical records will be reviewed. no clinic visits or procedures will be required.

this is a retrospective, observational study in participants with advanced nsclc with egfr exon-20 driven mutations. this study will look at clinical outcomes, patterns of care and disease management strategies and healthcare resource utilization (hcru) in a routine clinical practice setting in the real world. the study will enroll approximately 218 participants. participants who were treated at the participating sites between 01 january 2017 and 30 november 2021 will be included. the data will be collected retrospectively at the specialized centers from the participants medical records and notes. all the participants will be assigned to a single observational cohort: • participants with advanced nsclc with egfr exon-20 mutations this multi-center study will be conducted in canada, france and hong kong. the overall duration of the study will be 6 months.

Eligibility criteria:
inclusion criteria 1. histologically/cytologically confirmed diagnosis of locally advanced or metastatic (stage iib to iv) nsclc with egfr ex20ins mutations (based on the evaluation by the treating center) between 01 january 2017 and 30 november 2021. 2. followed-up at the site between 01 january 2017 and 30 november 2021 for his/her advanced nsclc, irrespective of their current survival status. exclusion criteria 1. participants whose investigator has access to fewer than two registered visits for his/her advanced nsclc between 01 january 2017 and 30 november 2021.

Keywords: drug therapy retrospective chart review nsclc mobocertinib egfr exon 20 nsclc real world
systematic escalation of diuretics with natriuresis in heart failure patients: serena trial

Conditions: Heart Failure

Summary: the present is a multicenter, prospective, randomized, open-label, blinded end-point trial aiming to investigate the clinical benefit of a stepwise, natriuresis-driven diuretic strategy versus standard diuretic treatment in patients with acute decompensated heart failure with reduced ejection fraction (hfref) and low early urinary sodium excretion. the study will focus on patients at increased risk of resistance to diuretic therapy. in particular, patients admitted to the emergency department and cardiac intensive care unit due to an on-chronic or de-novo acute decompensated hf episode with a predominantly "wet" profile and low early spot urinary sodium (una+) excretion will be considered. spot natriuresis is a low-cost, non-demanding laboratory test in use to identify diuretic-resistant patients with an inherent poor prognosis. whether the early identification of diuretic resistant patients and the consequent more aggressive treatment may lead to a better outcome has not been demonstrated by randomized studies. this trial aims to assess if an intensive stepwise diuretic approach guided by systematic urinary output assessment including natriuresis evaluation versus a standard diuretic strategy based on urinary output alone effectively leads to faster euvolemia achievement and better prognosis in a real-world setting.


Eligibility criteria:
inclusion criteria: * admission for acute decompensate chronic heart failure or acute de novo heart failure * ejection fraction \<40% * severe signs and symptoms of congestion with modified wet score ≥ 12 * spot urinary sodium excretion ≤ 70 meq/l at 2 hours from first intravenous loop diuretic administration * systolic blood pressure ≥90 mmhg exclusion criteria: * reversible etiology of acute heart failure (including acute coronary syndromes, myocarditis, acute pulmonary embolism, acute rhythm disorders, severe organic valve disease) * cardiogenic shock at admission or sign of hypoperfusion needing inotropic agents or mechanical circulatory support. * egfr lower than 15 ml/min/1.73m2 or dialysis * pregnancy or breastfeeding
genetic analysis in diagnosing thyroid cancer in patients with thyroid nodules

Conditions: Head and Neck Cancer

Summary: rationale: finding genetic markers for thyroid cancer in a biopsy specimen may help doctors diagnose thyroid cancer. purpose: this clinical trial is studying how well genetic analysis works in diagnosing thyroid cancer in patients with thyroid nodules.

objectives: * evaluate the diagnostic accuracy of biomarkers and mrna expression analysis using fine-needle aspiration (fna) biopsy samples from patients with thyroid nodules. * correlate the level of gene expression with the aggressiveness of differentiated thyroid cancer in fna biopsy samples. outline: patients undergo fine-needle aspiration (fna) biopsy as part of routine care. additional thyroid tissue is collected during the biopsy for gene expression analysis. patients who have already had a biopsy undergo fna biopsy during thyroidectomy. tissue samples will be examined for gene expression by reverse transcriptase-polymerase chain reaction (pcr), real-time quantitative pcr, and immunohistochemistry. projected accrual: a total of 400 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of a thyroid nodule that requires fine-needle aspiration biopsy or thyroidectomy to exclude a diagnosis of thyroid cancer patient characteristics: * platelet count ≥ 70,000/mm\^3 * pt (inr) ≤ 14.5 * ptt ≤ 35.2 * not pregnant prior concurrent therapy: * no aspirin or nonsteroidal anti-inflammatory drugs (nsaids) 7 days before sample procurement

Keywords: thyroid cancer
detecting neonatal hypoglycemia using real-time continuous glucose monitoring (cgm)

Conditions: Neonatal Hypoglycemia

Summary: hypoglycemia is the most common metabolic problem faced after birth. the investigators will be studying the utility of using a continuous glucose monitoring(cgm) system to more closely monitor low blood sugars in newborns. the investigators will evaluate the number of hypoglycemic events detected using cgm and compare it to those detected using current standard of care screening methods.

a cgm will be subcutaneously inserted by trained staff on a healthy area of skin and will be calibrated according to the manufacturer's instructions. blood glucose measurements will be taken using a blinded study glucometer to calibrate the device. calibration by trained study staff will take place about every 12 hours. sensor insertion sites will be monitored for infection throughout the course of the study by nursing and clinical staff or by trained study staff on an as needed basis. at the conclusion of the study, the cgm will be removed and assessed for signs of infection. study duration will be up to 7 days while the patient is admitted to the hospital. participants will be randomized into 2 groups. the control group will have a blinded cgm in place for the duration of the study. the remote monitoring group will be blinded to clinical staff. this group will have a cgm connected to an ipod that sends continuous glucose data to the study phone and will be monitored 24/7 by study staff. if a blood sugar level of \<46 mg/dl is detected, the infant will first be evaluated for positioning that could be causing a falsely low value. if the infant is re-positioned and cgm continues to show a blood sugar level of \<46 mg/dl, study staff will prompt the nurse taking care of the patient to obtain a capillary glucose value to verify the low blood sugar and treat it as deemed appropriate by the clinical team. the investigators will evaluate the number of hypoglycemic events that occur in the blinded cgm group versus the number that occur in the remote monitoring group to assess if the cgm is able to more sensitively detect low blood sugars in infants than current hospital standard of care measures.

Eligibility criteria:
inclusion criteria: * infants who are at least 34 weeks gestation that are born to mothers with gestational or pre-gestational diabetes and are admitted to lpch are eligible for the study. exclusion criteria: * infants \<2,000 grams will be excluded from the study. infants will also be excluded if they have an anomaly of the skin or subcutaneous tissue that would prevent proper adhesion, placement, and function of the sensor.
smartphone application for weight loss

Conditions: Obesity

Summary: aim: to assess the efficacy of an intervention that includes the assistance of a weight loss smartphone application targeted to young people aged 18 to 40 years. design: randomisedclinical trial. setting: primary health care centres (phccs) in catalonia. participants: adults aged 18 to 40 years with criteria of obesity or overweight, consulting phccs for any reason and who provide written informed consent to participate in the trial. intervention group will receive a 12-month weight loss programme that implements recommendations of a clinical practice guideline, complemented with a smartphone app designed specifically for this programme. control group will receive the usual care. the outcome measure will be weight loss at 12 months. expected results: the investigators expect a higher weight loss in the intervention group than in control group.

design: randomised clinical trial. setting: primary health care centres (phccs) in catalonia, spain. participants: adults aged 18 to 40 years with criteria of obesity or overweight, consulting phccs for any reason and who provide written informed consent to participate in the trial. intervention group will receive a 12-month weight loss programme that implements recommendations of a clinical practice guideline, complemented with a smartphone app designed specifically for this programme. control group will receive the usual care. the outcome measure will be weight loss at 12 months. expected results: the investigators expect a higher weight loss in the intervention group than in control group.

Eligibility criteria:
inclusion criteria: * young adults aged 18 to 40 years with overweight or obesity * availability of the patient's clinical history in the primary care centre * access to a smartphone device that meets the app requirements * access to an internet data connection exclusion criteria: * morbid obesity with bmi\> 40 * secondary obesity (eg endocrine pathology) * eating disorders (the patient or any member of the family); * presence of any significant comorbidity that a specific treatment (type 1 diabetes mellitus, severe mental illness); * pregnant or desire pregnancy in the next 12 months; * to participate in a weight loss program or taking any medication for weight loss in the moment of the recruitment * take any medication that may influence body weight;
laparoscopic sacropexy with robot-assisted surgical system

Conditions: Vaginal Vault Prolapse

Summary: the aim of the study is to evaluate safety and outcome of robot-assisted laparoscopic sacropexy regarding perioperative data, objective anatomical results and postoperative quality of life.

vaginal vault prolapse is a common finding in gynecology. many different approaches for vaginal vault prolapse repair are available. during the last few years robot-assisted surgery has been introduced in many surgical specialties and experiences in gynecologic surgery are very limited. several aspects like the wider range of motion of robot-instruments leading to more precision in surgery, the 3 dimensional optical system and the ergonomically designed console may offer some advantages. for better judgment these possible benefits as well as safety and outcome need to be evaluated and compared with conventional laparoscopic sacropexy techniques. this prospective clinical study evaluates robot-assisted laparoscopic sacropexy (da vinci®-system) focusing on peri-operative data, objective anatomical results and postoperative quality of life and compares the results with conventional laparoscopic sacropexy. pre- peri- and post-operative data are collected using the prolapse quantification system (pop-q) and the german pelvic floor questionnaire. the objective of the study will be to investigate if the robot assisted procedure shows significant advantages for the patient considering duration of surgery, complications, hospitalization, quality of life and costs.

Eligibility criteria:
inclusion criteria: * vaginal vault prolapse * recurrence after vaginal prolapse repair * signed consent exclusion criteria: * rectocele * bmi \> 40

Keywords: vaginal vault prolapse repair robot-assisted laparoscopic sacropexy robot-assisted laparoscopic sacrocolpopexy robotic laparoscopic sacropexy
efficacy and safety study of nasalfent for treatment of breakthrough cancer pain in patients taking regular opioids

Conditions: Cancers, Pain

Summary: cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. fentanyl is a strong, short-acting painkiller often used to treat this 'breakthrough' pain. nasalfent contains fentanyl in a patented drug delivery system called pecsys and is given via a simple nasal spray. this study will test the efficacy and safety of nasalfent compared to immediate release morphine sulphate in the treatment of breakthrough cancer pain.

current treatments for breakthrough cancer pain (btcp)work too slowly to meet the fast onset of most btcp episodes, they continue to act longer than the episode of pain lasts and so can have unwanted side effects due to this 'over treatment' of the pain episode. in addition many cancer patients have oral problems which make taking pain relief medication by mouth uncomfortable for the patient. nasalfent is administered via the nose as a simple spray and can be taken by patients or given by their carers. the nasal route is a common way to administer medication for example in the treatment of migraine or allergy. at any time during the study the patient may take their regular treatment for btcp should they so wish. this study will compare the time of onset and degree of pain relief of nasalfent to that of immediate release morphine sulphate. the safety of the two treatment options will also be examined.

Eligibility criteria:
inclusion criteria: * able and willing to give consent * women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception * diagnosis of cancer * taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain * experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication * able (or via caregiver) to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary * able to be up and about for 50% of the day or greater exclusion criteria: * intolerance to opioids or fentanyl * rapidly increasing/uncontrolled pain * pain that is not cancer-related

Keywords: pain cancer breakthrough