Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of tacs for depression: a multicenter rct study

Conditions: Depression Disorders

Summary: transcranial alternating current stimulation (tacs) is a promising non-invasive technique for major depression, because of its advantage of lower risks and expenses compared to other therapies such as deep brain stimulation, electroconvulsive therapy, and repetitive transcranial magnetic stimulation. randomized controlled trials (rcts) of depression treated by tacs have been conducted but provided limited and incongruous results. we designed a multi-center rct to evaluate the efficacy and safety of tacs for depression. eligible participants will be patients diagnosed with depression (hdrs-17≥8), aged 18 to 65, and without other conditions that could interfere with the study. a total of 72 participants will be recruited from 4 clinic centers. participants will be randomized 1:1 to active tacs or sham stimulation group. the study staff and the participants are blinded to the randomization results. stimulating electrodes will be placed on the scalp corresponding to bilateral dorsolateral prefrontal cortex (dlpfc) using frequency of 10hz and amplitude of 1.5 to 2.0 ma. the intervention will last for 4 weeks, containing 20 40-minute sessions in total. another 4-week observation will be followed by the end of the intervention. participants will receive assessments at baseline, 2 weeks, 4 weeks, 6 weeks, and 8 weeks after the study begins. psychological scales are used for the evaluation of their mental and quality of life. besides, electroencephalogram (eeg) recording and magnetic resonance imaging (mri) scans will also be performed to quantitatively measure the neural activities as well as the functional connectivity changes within the depression-related circuits.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of depressive disorder; 2. age ranges between 18 and 65 years; 3. hdrs-17 score equals to or above 8; 4. no medical history/under stable antidepressant treatment in one month; exclusion criteria: 1. combination of other psychotic disorders and neurological diseases; 2. history of invasive brain surgeries; 3. non-invasive neurostimulation treatments within 3 months; 4. physical condition that may endanger patients' safety during the study.

Keywords: tacs depression
safety, tolerability and efficacy of immunomodulation with at-1501 in islet cell transplantation

Conditions: Type 1 Diabetes Mellitus

Summary: this study will evaluate the safety, tolerability and efficacy of at-1501 in an immunomodulation regimen in adult patients with t1d undergoing an islet cell transplant.

this study will evaluate the safety, tolerability and efficacy of at-1501 in an immunomodulation regimen in adult patients with t1d undergoing an islet cell transplant. this study will also provide valuable data with respect to its potential additional uses in autoimmunity and solid organ transplant. this is a single arm open-label study and up to 6 participants will be recruited at a single center in canada. the objectives include: * to assess the safety and tolerability of immunomodulation with at-1501, in combination (at+) with rabbit anti-thymoglobulin (atg), etanercept and mycophenolate mofetil (mmf/ec-mps) in adults with t1d undergoing islet cell transplant. * to assess the efficacy of immunomodulation with at-1501 in adults with t1d undergoing islet cell transplant. the duration of treatment may vary from participant to participant and could be up to 20 months. participants may receive up to 2 islet cell transplants.

Eligibility criteria:
inclusion criteria: 1. men and women 18-65 years of age 2. a diagnosis of t1d ≥5 years with onset of disease at \<40 years of age 3. involvement in intensive diabetes management as directed by an endocrinologist or diabetologist with at least 3 clinical evaluations within the 12 months prior to screening; using an insulin pump or multiple daily injection (mdi) insulin therapy; and, unable to achieve acceptable metabolic control because of the occurrence of severe hypoglycemia 4. at least 2 unexplained shes not secondary to a missed meal or dosing error, etc., in the 12 months prior to screening 5. glycosylated hemoglobin (hba1c) level greater than 7% (53 mmol/mol) and less than 9.5% (80 mmol/mol) inclusive 6. absence of stimulated c peptide (\< 0.3 ng/ml) in response to a mixed meal tolerance test (mmtt) measured at 60 and 90 minutes after the start of consumption 7. reduced awareness of hypoglycemia as defined by a clarke score \[clarke 1995\] of 4 or more at the time of screening, during the screening period and within the last 6 months prior to the transplant exclusion criteria: 1. any previous transplant 2. hba1c level less than 7% (53 mmol/mol)

Keywords: type 1 diabetes t1d islet cell transplant at-1501 humanized blocking antibody to cd40l cd40l inhibitor monoclonal antibody glucose metabolism diseases diabetes mellitus, type 1 endocrine system diseases graft metabolic diseases immune system diseases autoimmune diseases hypoglycemia hyperglycemia
anonymous treatment on the internet for alcohol dependence: a randomised, controlled trial

Conditions: Alcohol Abuse; Alcohol Dependence; Harmful Alcohol Use; Alcohol Use Disorder

Summary: internet based self help program with or without support of a counselor is tested among anonymous internet help seekers at an open access website.

a 5 module internet based self help program based on motivational interviewing and cognitive behavioral therapy is tested among anonymous internet help seekers.the design is a three armed randomized controlled study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 2400 participants are recruited entirely online from an open access website. consenting participants will be randomized into one of three groups: 1.internet based self help program with counselor support, 2.internet based self help program without counselor support or 3. information about the open access websites resources: information on alcohol and health, where you can find treatment and a online discussion forum. follow-up will be conducted online after 3, 6, 12 and 24 months in all three groups.

Eligibility criteria:
inclusion criteria: audit-score \>16 points and/or at least 3 criteria of alcohol dependence (icd-10) exclusion criteria: inadequate swedish language skills no internet access

Keywords: randomized controlled trial alcohol internet internet based therapy cognitive behavioral therapy
population pharmacokinetics and dosage individualization of antibiotics in elderly patients

Conditions: Elderly Infection

Summary: the investigator's purpose is to study the pharmacokinetics and pharmacodynamics of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly icu patients and recommend an individual dosage regimen of those antibiotics.

the use of biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc in elderly icu patients during clinical treatment depended mostly on experience. besides, there was no recommended dose for elderly patients in drug instruction, therefore, we aim to study the pharmacokinetics and pharmacodynamics in elderly icu patients and provide a tailormade regimen.

Eligibility criteria:
inclusion criteria: * (1) age ≥65 years old; (2) according to the doctor's advice, use biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc for anti-infection treatment; exclusion criteria: * (1) patients who are expected to die within 48 hours; (2) patients with allergic to β-lactam antibiotics, carbapenems, ticacycline and levofloxacin.etc drugs; (3) patients receiving other investigational drugs; (4) other factors that the researcher considers unsuitable for inclusion.

Keywords: biapenem,meropenem,piperacillin and tazobactam,tigecycline,levofloxacin.etc elderly icu patients dosage regimen pharmacokinetics and pharmacodynamics
study of trilaciclib and lurbinectidin

Conditions: Lung Cancer; Small-cell Lung Cancer

Summary: lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. small cell lung cancer (sclc) is the deadliest form of lung cancer. the standard first-line treatment is the combination of carboplatin, etoposide, and atezolizumab. while response rates for this regimen are high (roughly 60%), the duration of response is short, typically 4 months. following progression after the 1st line treatment of sclc, there is no consensus regarding subsequent therapy. lurbinectedin is fda approved and is increasingly preferred in clinical practice. toxicity was significant, but appeared favorable compared to historic results with topotecan, leading to the adoption of this therapy for second-line sclc. the toxicity profile was dominated by myelosuppression. this study investigates the effect of trilaciclib on myelosuppression rate in subjects with platinum refractory extensive stage (es)- sclc receiving lurbinectedin as well as the clinical synergy of trilaciclib and lurbinectedin combination.


Eligibility criteria:
in order to participate in this study, a subject must meet all of the eligibility criteria outlined below. inclusion criteria: * written informed consent obtained to participate in the study and hipaa authorization for release of personal health information. * age ≥ 18 years at the time of consent. * eastern cooperative oncology group (ecog) performance status of 0-1 * measurable disease according to recist v1.1 within 28 days prior to start of treatment. * previous treatment with a platinum agent, pd1 or pdl1 agent. exclusion criteria: * active infection requiring systemic therapy. * pregnant or breastfeeding (note: breast milk cannot be stored for future use while the mother is being treated on study). * treatment with any investigational drug within 4 weeks prior to start of treatment. * a known allergy or sensitivity to either study drug or its excipients. * subject is receiving prohibited medications or treatments as listed in the protocol.

Keywords: lurbinectedin trilaciclib myelosuppression neutropenia
efficacy of diclofenac potassium vs nimesulide in the treatment of fever and pain in children with upper respiratory tract infection

Conditions: Upper Respiratory Tract Infections

Summary: this is a local, phase iv, open-label, randomized, head to head study of children aged 3 to 7 years. the objective of the study is to compare the efficacy of a single dose of both diclofenac potassium and nimesulide in the reduction of fever and pain secondary to upper respiratory tract infection.


Eligibility criteria:
inclusion criteria: * children who present community acquired, non-complicated, upper respiratory tract infection: rhino-sinusitis, pharyngitis, tonsillitis, ear infection or the combination of these. * child must present axillary temperature ≥ 37.5°c. exclusion criteria: * prior history of allergic reaction to the components of the study medication. * use of any nsaid or pharmacologic agent in the 24 hours prior to visit 1. * subjects who, in the opinion of the investigator, have developed, or are at risk of developing, a complicated infection and are not suitable subjects for the purposes of the study. other protocol-defined inclusion/exclusion criteria may apply

Keywords: upper respiratory tract infections diclofenac potassium nimesulide fever pain
combining rt with immunotherapy and chemotherapy in metastatic nasopharyngeal carcinoma

Conditions: Metastatic Nasopharyngeal Cancer

Summary: incidences of de novo metastatic nasopharyngeal carcinoma range from 6% to 8% at the time of presentation. for the initial diagnosis of metastatic npc, pd-1 plus chemotherapy yields a satisfactory outcome with1year pfs of 40%. previous study demonstrated the benefit of adding radiotherapy to chemotherapy in metastatic npc, however there is no evidence whether radiotherapy can further improve pfs based on chemotherapy plus pd-1 . the purpose of this study is to evaluate the safety and effectiveness of first-line immunochemotherapy combined with radiotherapy for initial diagnosed metastatic npc.


Eligibility criteria:
inclusion criteria: * age:18-75 years, male or female. * ecog 0-2 * histologically or cytologically confirmed de novo metastatic nasopharyngeal carcinoma.(stage ivb, ajcc 8th) * complete response or partial response after at least 3 cycles (no more than 6 cycles) of chemotherapy combined with immunotherapy * measurable disease based on response evaluation criteria in solid tumors (recist) 1.1. * adequate organ function. * patient has given written informed consent. exclusion criteria: * unwilling or unable to provide informed consent * intolerance to radiotherapy or immunotherapy * patients who have head and neck radiotherapy history. * previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ * women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * in other clinical trials within 30 days * patients with autoimmune disorder, including but not limited to systemic lupus erythematosus or multiple sclerosis; * history of primary immunodeficiency * history of active tuberculosis, drug-induced interstitial lung disease, or ≥ grade 2 pulmonitis; * patients with human immunodeficiency virus (hiv) positive; * comorbidities that cannot be controlled by concomitant treatment, including but not limited to: ongoing or active infection, unexplained fever \> 38.5°c (subjects with neoplastic fever are judged by the investigator to be included), symptomatic congestive heart failure ≥ grade 2 according to new york heart association (nyha) functional classification, lvef (left ventricular ejection fraction) \< 50%, hypertension poorly controlled by drugs, unstable angina, arrhythmia, active peptic ulcer disease or gastritis; * not suitable for this study judged by researchers

Keywords: metastatic nasopharyngeal cancer pd-1 radiotherapy chemotherapy
colonic polypectomy in cirrhotic patients with portal hypertension

Conditions: Liver Cirrhosis; Portal Hypertension Related to Cirrhosis; Polyp of Colon; Polypectomy

Summary: the goal of this retrospective cohort study is to evaluate the risk of post-polypectomy bleeding following the colonoscopy resection of lower gastrointestinal polyps in patients with liver cirrhosis with portal hypertension. the main question it aims to answer is: does the risk of bleeding increase after colonoscopy polypectomy in patients with liver cirrhosis with portal hypertension? participants will be subjected to polypectomy of any colonic polyps.


Eligibility criteria:
inclusion criteria: * all liver cirrhosis patients with portal hypertension and colonic polyps exclusion criteria: * patients with platelet count less than 50,000/µl. * patients with hemoglobin levels less than 8 g/dl. * prothrombin time more than 20 seconds.

Keywords: colonic polyp polypectomy portal hypertension post-polypectomy bleeding
long-term interventional follow-up study of children with prader-willi syndrome included in the otbb3 clinical trial

Conditions: Prader-Willi Syndrome

Summary: this study is a prospective, multicentre, interventional cohort study in children with prader-willi syndrome (pws) over 4 years (no treatment administered). the duration of the preceding ottb3 study is 26 weeks. an untreated cohort of children with pws will be included at an age of 2 years and followed up until an age of 4 years. regarding the untreated cohort, children with pws born in france and too old to be recruited in otbb3 trial, principally those who were born within one year before the start of otbb3 trial, will be offered to participate in this study. infants born later who couldn't be included in otbb3 study will be also offered to participate.


Eligibility criteria:
inclusion criteria: 1. male or female child with a genetically confirmed diagnosis of pws (patients can be enrolled if the genetic subtype is not available at inclusion, but the genetic subtype needs to be confirmed during the study); 2. the parents (or legal representative) must have signed the consent form; 3. treated cohort: the child participated in the otbb3 study and is aged 16±4 months at inclusion, 4. untreated cohort: the child has never received ot, is aged 30±6 months at inclusion (in order to maximise the number of children in the untreated cohort) and is followed in france. exclusion criteria: 1. administrative problems: 1. inability for the parents (or legal representative) to understand/fulfil study requirements; 2. no coverage by a social security regime; 2. refusal of parents (or legal representative) to sign the consent form;

Keywords: prader-willi syndrome oxytocin
identification of admission high risk elderly

Conditions: Pneumonia; Urinary Tract Infection; Stroke

Summary: objective: the study aim to establish high risk admission model and readmission model for elderly in taiwan. method: investigators compare the clinical, epidemiological, and socioeconomic characteristics of admitted patients during 1 august,2011 to 31 july,2012. all patients will follow up to end of study to identify 14 days readmission and 30 days readmission to geriatic ward. expected outcomes: (1) to compare the prediction value of derivation cohort and validation cohort. (2) to identify high risk indicators of admission and readmission for elderly. (3) to determine the risk factors in admission elderly association with quality indicators.


Eligibility criteria:
inclusion criteria: 1. patients with age 65 year old above 2. patients admission to geriatric ward exclusion criteria: 1. patients with unstable vital sign 2. patients or dependants reject to sign inform consent.

Keywords: admission high risk elderly
valproate versus propranolol in migraine

Conditions: Migraine Disorders

Summary: investigators aim to compare the effect of valproate versus propranolol in migraine by assessing the absolute reduction in mmd in each group and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency.

investigators will enrol 600 migraine patients who are diagnosed according to ichd3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 500-1000 mg valproate daily, and the second group will receive propranolol 160 mg per day. investigators will assess the number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. the safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (teae) in patients through regular follow-up procedures for three months.

Eligibility criteria:
inclusion criteria: naive migraine patients, according to the international classification of headache disorders 3rd edition, aged 18-75 years, exclusion criteria: * patients with major neurological disorders such as (epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumours, and patients with essential tremors. * patients with major systemic diseases such as malignancy, collagen, liver, and renal diseases. * patients with cardiovascular diseases like hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/hg on at least three different occasions, diabetes (fasting plasma glucose level \>126 mg/dl and/or a casual plasma glucose \>200 mg/dl and/or hba1c more than 6.5. * patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure * patients who received prophylactic treatment for migraine, * patients with any contraindications to drugs used in the study * patients with bronchial asthma, chronic obstructive pulmonary disease

Keywords: propranolol valproate migraine
behavioural economics-based incentives in adults with type 2 diabetes (bet2)

Conditions: Diabetes Mellitus, Type 2

Summary: a randomised control trial of adults with newly diagnosed type 2 diabetes to assess the effectiveness of behavioural economics-based incentives on healthy lifestyle behaviour, using a pragmatic trial approach.

this is a randomised control trial of adults aged 30-70 with newly diagnosed type 2 diabetes within a year in hong kong to compare the effectiveness of financial incentives and combined financial and social incentives against a control group receiving standard care. we plan to recruit 261 participants and follow them for 9-months (6-month intervention period and a 3-month post-intervention follow-up period) to assess glycemic control and other health indicators. participants will be randomly assigned to one of three groups (in ratio 1:1:1): arm a (financial incentives in addition to standard care), arm b (financial and social incentives in addition to standard care), and arm c (control arm receiving standard care). financial incentives will be framed around loss aversion and the endowment effect. social incentives will include peer competition, and social support. financial and social incentives are to encourage increased physical activity and participants will use a pedometer to track activity. participants are followed for an additional 3-months after the cessation of incentives to assess the sustainability of lifestyle changes. this trial adopts a pragmatic study design based on the precis-2 tool and re-aim frameworks.

Eligibility criteria:
inclusion criteria: * chinese adults aged 30-70 years * capable of providing informed consent * resident in hong kong * able to communicate in english or chinese * diagnosed with type 2 diabetes within past year * 6.5% ≤ hba1c ≤ 9.0% * willing to take blood tests * access to a phone to track physical activity and receive text messages * physically mobile for duration of the trial exclusion criteria: * planned surgery in the next 6 months * biological impairment or health condition affecting the ability to walk, such as blindness, physical immobility, and paralysis * pregnant or breastfeeding * on insulin for diabetes control
alternate-day buprenorphine administration. phase vii - 8

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to determine if four times a subjects daily maintenance dose will hold for 96 hours without changes in agonist and antagonist effects under open dosing conditions.


Eligibility criteria:
please contact site for information.
occupational performance coaching in mothers of children with cerebral palsy

Conditions: Cerebral Palsy

Summary: a single-blind randomized controlled trial will be used to test the efficacy of the opc on self-efficacy and occupational performance with mothers of children with cerebral palsy. canadian occupational performance measurement and sherer general self-efficacy scale will be employed to data collection. the sample size was determined for each group of 15 people. the participants conveniently and according to inclusion and exclusion criteria will be randomized into the groups. participants in the intervention group will be participated in 10 sessions of opc. at the end the questionnaires will be completed by both groups.


Eligibility criteria:
inclusion criteria: mothers: being literate 25 to 25 caring nobody disabled other than her child children: 5 to 12 cerebral palsy exclusion criteria: children: others problems that affect on communication