Kornimate/medical-research-clean huggingface dataset:
long-acting injectable risperidone in patients with schizophrenia after an acute episode

Conditions: Schizophrenia

Summary: the primary objective of this randomized trial was to investigate whether early initiation of treatment with risperdal consta after an acute episode was not inferior to the routine approach (oral treatment for 12 weeks followed by treatment with risperdal consta). .

although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regiment. long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. traditionally, patients experiencing an episode of schizophrenia are first treated with oral medications until they are stabilized, and then injectable long-acting formulations are given. this is an open, multicenter, randomized phase iv trial in patients after an acute episode of schizophrenia. patients will be in the trial for 6 months. one treatment group will receive injections starting at baseline (early initiation); the other group will start with treatment as usual at baseline and begin injections at week 12 (late initiation). assessment of effectiveness include positive and negative syndrome scale (panss), in order to measure symptoms of schizophrenia; clinical global impression - severity (cgi-s), measuring overall severity of illness; global assessment of functioning (gaf), assessesing overall psychological, social, and occupational functioning; and quality of life questionnaire sf-12, measuring overall health status. safety evaluations include the extrapyramidal symptoms rating scale (esrs), incidence of adverse events throughout the study, and vital signs (pulse, blood pressure). the study hypothesis is that early initiation of long-acting risperidone injections is not inferior to late initiation as measured by changes in panss total score from baseline through endpoint (after 6 months). risperidone, long-acting formulation for intramuscular injections (25 to 50 mg (maximum)), given every 14 days through 6 months, starting at baseline or month 3. treatment as usual for 3 months for late initiation group

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia by criteria of diagnostic and statistical manual of mental diseases, fourth edition (dsm-iv) * acute episode of schizophrenia within 2 weeks of study entry * o subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose * positive and negative syndrome scale (panss) score \>=80 * clinical global impression - severity (cgi-s) score \>=5 exclusion criteria: * dsm-iv axis i diagnosis other than schizophrenia * known hypersensitivity or lack of response to risperidone * pregnant or nursing females, or those without adequate contraception * alcohol or drug abuse or dependence diagnosed in the last month prior to entry,

Keywords: schizophrenia intramuscular injection antipsychotic agents long-acting risperidone
autoimmune hepatitis cohort in china

Conditions: Autoimmune Hepatitis

Summary: the goal of this observational study is to describe the clinical features and long-term prognosis in patients diagnosed with autoimmune hepatitis (aih) in china and assess the effectiveness and safety of aih treatment options in a real-world setting.

autoimmune hepatitis (aih) is a chronic autoimmune liver disease that causes liver inflammation and necrosis, ultimately leading to cirrhosis and liver failure. although relatively rare, the prevalence of aih in china has been increasing in recent years, highlighting its significance as a public health issue. however, due to the wide variability in the clinical presentation and outcomes of aih, diagnosing and managing the disease can be challenging. moreover, our understanding of the epidemiology, clinical features, diagnosis, and treatment of aih in china is still limited. to address this gap in knowledge, the investigators are conducting the chinese aih cohort study, which collects data from approximately 20 sites across china on treatment progress and success in clinical routine. the study aims to evaluate the effectiveness and safety/tolerability of different aih treatment options, including standard therapy, and second and third-line treatment options. the investigators also record the long-term prognosis of patients with aih, tracking whether they achieve remission, require liver transplantation, or experience mortality. risk factors associated with long-term prognosis and survival will be analyzed to provide insights that can improve the diagnosis, treatment, and management of aih in this population.

Eligibility criteria:
inclusion criteria: * age ≥ 14 years * probable or definite diagnosis of autoimmune hepatitis according to the international autoimmune hepatitis study group criteria * availability of all following essential parameters at the initial diagnosis of aih: including alanine transaminase, aspartate aminotransferase, total bilirubin, alkaline phosphatase, immunoglobulin g, and platelet count * provide informed consent exclusion criteria: * have a concomitant diagnosis of primary biliary sclerosis, primary sclerosing cholangitis, immunoglobulin g 4-related cholangitis * have an active infection with hepatitis b virus, hepatitis c virus, hepatitis delta virus, hiv, cytomegalovirus, or epstein-barr virus * have a concomitant diagnosis of hepatocellular carcinoma or other malignant diseases before the diagnosis of aih * considered ineligible to the enrollment in the clinical study by the researcher
maximal use of luliconazole cream 1% in pediatric participants with moderate to severe tinea pedis or tinea cruris

Conditions: Tinea Pedis; Tinea Cruris

Summary: the objective of this study is to evaluate the pharmacokinetics of luliconazole cream 1%, as measured by circulating plasma levels of luliconazole, when maximal quantity of luliconazole cream 1% is applied to participants of 12 years to less than (\<) 18 years of age with moderate to severe inter-digital tinea pedis or tinea cruris.


Eligibility criteria:
key inclusion criteria: * participants (or legal guardian) with the ability and willingness to sign a written informed consent. * participants of either gender at least 12 years to \<18 years old (12 to 17 years, inclusive). * participants with a mycological diagnosis of tinea pedis or tinea cruris confirmed by the detection of fungal hyphae on a microscopic potassium hydroxide (koh) wet mount. * participants with the ability and willingness to follow all study procedures, attend all scheduled visits, have all blood draws, and successfully complete the study. * participants must be in good general health and free of any disease that in the investigator's opinion might interfere with the study evaluations. * participants must be able to communicate, be able to understand the study procedures, and be willing to comply with the study requirements. key exclusion criteria: * participants with both tinea pedis and tinea cruris. * participants with active atopic or contact dermatitis in the treatment area. * female participants who are pregnant and/or nursing or planning a pregnancy during the course of the trial. participants who test positive for pregnancy after start of test treatment will be discontinued from test treatment but will be followed for safety purposes. * participants who are immunocompromised (due to disease, for example; human immunodeficiency virus \[hiv\] or medications). * participants who have a recent history of or current drug or alcohol abuse.
active-ibd study: physical activity and sleep in paediatric inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Exercise

Summary: assessment of physical activity on children with inflammatory bowel disease using questionnaires and wrist watch based activity monitors. the participants will be recruited from paediatric ibd clinics and will undergo questionnaires to assess their activity level, disease activity and quality of life scores. the participants will then be invited to wear a wrist based accelerometer for a week. the participants will complete a physical activity diary, food diary and stool chart at the same time. results will be analysed to see the level of physical activity and assess if the participants are meeting the recommended level of physical activity


Eligibility criteria:
inclusion criteria: * children/adolescents from age of 6 to 18 years of age * confirmed endoscopic/histology based ibd diagnosis * under the care of the southampton university hospitals nhs foundation trust paediatric gastroenterology team * able to provide consent / assent to participate in the study * able to understand and/or cooperate with the study requirements * pregnant participants will be included as long as they can complete the physical assessmentsexclusion criteria:

Keywords: exercise sleep quality of life physical activity
couples fertility and pregnancy awareness

Conditions: Fertility; Decision to Get Pregnant

Summary: recent evidence has shown that young people that want to have children have low fertility knowledge. this study evaluates the efficacy of a video intervention on fertility knowledge, on changes in lifestyle and on the decision to start to get pregnant.

this study will compare the efficacy of a video intervention versus control (no video) in couples that intend to have children in the next three years. the couples will be randomized to the two groups. the video contains information concerning age-related fertility decline, fertility risk factors, the success of infertility treatments, and emotional consequences of childlessness.

Eligibility criteria:
inclusion criteria: * female member of the couples has between 24 to 40 years * childless couples trying to conceive or couples who desired to have children in the next 3 years * relationship length minimum of one year exclusion criteria: * couples that already had achieved a successful pregnancy * couples with children

Keywords: infertility fertility awareness preconceptional care health interventions couples
longitudinal non-invasive analysis of vocale cord function based on trans-laryngeal ultrasound acquisitions and voice recordings

Conditions: Postoperative Dysphonia

Summary: the main objective of vocalise study is to propose a new approach allowing a better characterization of postoperative dysphonia. this involves associating with dynamic translaryngeal ultrasound optimized acquisitions of the vibration of each vocal fold in phonation simultaneously with voice recordings. a software program to analyze the displacement of arytenoids, markers of substitution of the vocal cords, will be developed to finely quantify the mobility of laryngeal structures, by combining classical methods of motion analysis and deep learning methods. this approach will be evaluated to follow speech therapy rehabilitation in patients with post-operative dysphonia following recurrent nerve injury.

dynamic translaryngeal ultrasound (dtlus), a non-invasive and inexpensive technique, has emerged in recent years as an alternative to nasofibroscopy for assessing vocal cord paralysis. this paralysis is the major risk (3 to 5%) associated with cervical surgery (100,000 procedures per year in france). initial work by our consortium has demonstrated the performance of dtlus after thyroid or parathyroid surgery in the early diagnosis of vocal cord paralysis. the aim of vocalise is to propose a new approach for better characterisation of post-operative dysphonia. this involves combining optimised dtlus acquisitions with acquisitions of the vibration of each vocal cord during phonation, simultaneously with voice recordings. software will be developed to analyse the displacement of the arytenoids, which are surrogate markers for the vocal cords, in order to quantify the mobility of laryngeal structures in fine detail, using a combination of conventional motion analysis methods and deep learning methods. this approach will be evaluated to monitor speech therapy rehabilitation in patients with post-operative dysphonia following a lesion of the recurrent nerve.

Eligibility criteria:
inclusion criteria: * patient over 18 years of age * obtaining patient's free and informed consent * patients with dysphonia following cervical surgery and referred for speech therapy * social security scheme membership (beneficiary or entitled), excluding ma exclusion criteria: * known preoperative history of recurrent nerve paralysis (pr) * history of laryngeal or vocal cord tumour * surgical complications preventing proper assessment of postoperative vocal cord mobility (tracheotomy, tracheal resection). * patients with a history of thyroid or parathyroid surgery or cervicotomy for another pathology * patient under guardianship or guardianship or deprived of liberty or under safeguard of justice * pregnant or nursing patient * patient does not read or has vision problems * cognitive and/or auditory impairment preventing

Keywords: motion mode ultrasound voice recordings grbasi scale vhi
real-world analysis on the efficacy and safety of neoadjuvant therapy for head and neck squamous cell carcinoma （neohnscc）

Conditions: Head and Neck Squamous Cell Carcinoma

Summary: this is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for head and neck squamous cell carcinoma. this trial will also explore the biomarkers of neoadjuvant immunochemotherapy.

this is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for head and neck squamous cell carcinoma. this trial will also explore the biomarkers of neoadjuvant immunochemotherapy. patients with untreated, operable, or potentially resectable hnscc will be included.the pathological results, adverse events and other information of eligible patients will be collected.

Eligibility criteria:
inclusion criteria: * age 18-80, male or female； * cytologically or histologically diagnosed squamous cell carcinoma (except mixed squamous cell carcinoma)； * there was at least one radiographically measurable lesion according to the solid tumor response evaluation criteria (recist version 1.1)； * patients with untreated, operable, or potentially resectable head and neck squamous cell carcinoma； exclusion criteria: * malignant diseases other than head and neck squamous cell carcinoma diagnosed within 5 years prior to first administration (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection)； * currently participating in an interventional clinical study or has received another investigational drug or has used investigational devices in the 4 weeks prior to initial dosing； * evidence of medical history or disease that may interfere with trial results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator deems unsuitable for enrollment；

Keywords: hnscc neoadjuvant immunochemotherapy
estimation of average and beat-to-beat heart rate with a novel wrist-worn ppg device in surgery patients

Conditions: Atrial Fibrillation

Summary: the aim of the study is to the reliability and feasibility of a novel optical heart rate monitor in hospital patients. especially patients with atrial fibrillation are included. patients will be monitored for two hours during routine post-operative care. the data from study device will be compared to routine monitoring. the design of the study is a pilot feasibility study.

the primary use of photoplethysmography (ppg) measurement in clinical settings is usually the determination of the blood oxygen saturation level of the patient. the same device often reports also an average pulse rate of the subject. if the subject has low blood perfusion in the hands or suffers from acute atrial fibrillation, the determination of the pulse rate is challenging and therefore the readings provided by current technology are unreliable. optical heart rate monitors (ohr) have recently become popular in sports and wellness applications and their performance in healthy subjects having normal blood perfusion in the extremities is well studied and documented and good accuracy has been shown healthy subjects. the performance of wrist-worn ohr monitors in hospital patients, however, has not been extensively studied. the aim of the study is to test novel wrist-worn photoplethysmographic (ppg) device in surgery patients and study its feasibility in detecting heart rate and beat to beat heart rate of patients having normal sinus rhythm or arrhythmia, such as atrial fibrillation (af).

Eligibility criteria:
inclusion criteria: * age: \> 18 years * subjected to surgery at tampere university hospital * spontaneously ventilating * volunteering for the study * able to give a written informed consent exclusion criteria: * having a cardiac pacemaker * surgical operation performed in wrist area or any other reason that prevents placing the wrist-worn device in correct location * neurological disease (e.g. parkinson's) possibly causing notable amount of shivering * non-caucasian skin colour * inability to give an informed consent * denial of participation

Keywords: postoperative monitoring plethysmography monitoring
phase ii trial of adjuvant cisplatin and radiation with pembrolizumab in resected head and neck squamous cell carcinoma

Conditions: Head and Neck Cancer

Summary: the purpose of this research study is to test the safety and the benefit of adding pembrolizumab (a therapy that activates the immune system to fight cancer) to standard of care treatment for head and neck cancer. the standard of care treatment will include surgery followed by radiation for 6 weeks. some patients may also receive cisplatin as standard of care once a week for 6 weeks if the cancer is found to be "high risk". high risk includes cancer that was not completely removed (positive margins) or cancer that has invaded through the outer lining of your lymph nodes.


Eligibility criteria:
inclusion criteria: * patients eligible for resection with one or more of the following 1. any t stage with ≥ n2 disease; 2. t4 disease, any n stage; 3. t3 oral cavity, any n stage; or 4. clinical evidence of extra-capsular extension on scans. * must be willing to undergo definitive resection with neck dissection. * performance status 0 or 1 on eastern cooperative oncology group performance scale. * adequate labs * appropriate staging imaging. exclusion criteria: * diagnosis of immunodeficiency or receiving systemic steroid therapy or immunosuppressive therapy within 7 days prior to planned first dose of trial treatment. * nasopharyngeal or sinonasal carcinoma * confirmed metastatic disease * human papillomavirus (hpv)+ disease of the oropharynx * known history of active tuberculosis (tb), autoimmune disease, pneumonitis, infection, hiv, hepatitis b, or hepatitis c
molecular characterization of primary mucosal melanoma

Conditions: Mucosal Melanoma

Summary: primary mucosal melanomas (mpm) are rarer than cutaneous melanomas, but also more severe. they are usually refractory to conventional approaches, regularly excluded from major therapeutic programs and not sensitive to new targeted therapies orphans. " the identification of therapeutic targets and accessibility to existing, developing or future targeted therapies improves the survival of patients with mpm. the principal goal is to describe, using a large panel of genes, the prevalence of major mutations in a cohort of mpms based on the population of a french region.


Eligibility criteria:
inclusion criteria: * incident mucosal melanoma in the champagne-ardenne region 2004-2014 exclusion criteria: * cutaneous melanoma * uveal melanoma
effectiveness of phenazopyridine for pain following urodynamics

Conditions: Pain After Urodynamic Testing

Summary: the purpose of the study is to determine if taking phenazopyridine (azo) at the time of urodynamic study testing will decrease pain experienced by patients after undergoing urodynamic testing.


Eligibility criteria:
inclusion criteria: * ability to provide informed consent * ability to complete visual analog scale * requiring urodynamic testing * 18 years of age or older * must be able to read and write in english or spanish exclusion criteria: * allergy to phenazopyridine * a urinary tract infection in the prior 2 weeks * women who did not undergo urodynamic testing * patient less than 18 years old * patients with known (noted in patient chart and verbally asked) severe renal insufficiency with gfr \<50 ml/min, * patients with known (noted in patient chart and verbally asked) severe hepatitis * patients with known (noted in patient chart and verbally asked) g6pd deficiency * history of fibromyalgia * history of interstitial cystitis * non english or spanish speaking
a evaluation of systematic intensive therapy using cgm/fgm in clinical diabetes care

Conditions: Type1diabetes

Summary: this study aims to analyse if intensive systematic treatment via internet and telephone during 4 months improved hba1c for persons with type 1 diabetes which are already treated with cgm or fgm, and if the effect continuous for 1-2 years after the intervention stops. time in hypoglycaemia, treatment satisfaction, diabetes distress and hypoglycaemia fear will even be analysed. a randomised, non-blinded, multi-centre, clinical study for persons with type 1 diabetes and hba1c ≥ 58mmol/mol and treated with cgm or fgm. the control group continuous its normal diabetes care with study visits at randomisation, 10, 18, 32, and 52 weeks for hba1c and to fill in questionnaires. the intervention group will have contact with the study team on a weekly basis, when mean blood glucose levels the previous week are elevated. they will receive help with analysing data and advice on how to improve their glucose values. they will even meet the study team at randomisation, 10, 18, 32, and 52 weeks for hba1c and to fill in questionnaires.


Eligibility criteria:
inclusion criteria: * informed consent obtained before trial-related activities (i.e., any activity that would not have been performed during routine patient management) * clinical diagnosis of type 1 diabetes * adult patients over 18 years of age * hba1c ≥ 58 mmol/mol * currently using cgm or fgm * to have a possibility to download and share fgm/cgm data exclusion criteria: * type 2 diabetes * diabetes duration \<1 year * long-term systemic glucocorticoid treatment during the last 3 months * planned or changed treatment the last 3 months regarding mdi vs. insulin pump or added or stopped cgm or fgm therapy * current or planned pregnancy or breastfeeding during the next 12 months * planned move during the next 12 months making it not possible to participate in study activities * other reason determined by the investigator not being appropriate for participation