Kornimate/medical-research-clean huggingface dataset:
incidence of subtalar joint fusion after isolated ankle fusion

Conditions: Ankle Arthritis

Summary: it is important to know a truer incidence of the need for subtalar and midfoot fusions, following an isolated ankle fusion, in order to better inform our patients of the likelihood of needing further surgery in the future. it is also important to understand whether pre-existing radiological arthrosis is likely to lead to the need for a fusion in the future and also how important the alignment of the ankle joint, after a fusion, may influence that. the aim of the study is to review the patients' notes and radiology who have had a previous isolated ankle fusion and then to see whether they subsequently required further surgery.

isolated ankle fusion is normally regarded as a good operation producing good pain relief and allowing patients to function well. patients will have an early heel rise when walking and although that is often not immediately perceptible to an onlooker, it does increase the stress on the neighbouring subtalar and chopart joints. radiologically, subtalar joint arthrosis is common following isolated ankle fusions but not necessarily clinically symptomatic. the long term incidence of subsequent ipsilateral subtalar or chopart joint fusions is not well known. various different studies have shown a prevalence of osteoarthrosis (radiologically) of 24-100% in the subtalar joint and reported 84% of patients complaining of pain after 10 years. the prevalence in the chopart joints has been reported to vary between 18-77%. this is an observational study reviewing medical records and radiology of patients who have had an isolated ankle fusion. the data will be analysed using basic statistics with logistic regression modelling.

Eligibility criteria:
inclusion criteria: any patient who has had an isolated ankle fusion and is over the age of 18 years old. exclusion criteria: participants younger than 18 years old.
study of s-1, s-1/cddp, and 5-fu/cddp for advanced gastric cancer

Conditions: Gastric Cancer

Summary: this is an open-label, multicenter, three arm, parallel, randomized, phase 3 study evaluating the efficacy and safety of s-1 alone compared with s-1 plus cddp, and s-1 plus cddp compared with 5-fu plus cddp in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. patients will be randomly assigned (1:1:1) to s-1 (arm a), s-1/cddp (arm b) or 5-fu/cddp (arm c). patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs \>1), prior gastrectomy, and center.


Eligibility criteria:
inclusion criteria: * non-prior chemotherapy treated advanced gastric adenocarcinoma * age 18 and over * performance status 0, 1, or 2 (ecog) * life expectancy 3 months * hematopoietic wbc lower limit of normal-12,000/mm\^3 absolute granulocyte count ≥ 2,000/mm\^3 platelet count ≥ 100,000/mm\^3 hemoglobin ≥ 8.0 g/dl * hepatic ast and alt ≤ 100 u/l alp ≤ 2 times upper limit of normal (uln) bilirubin ≤ 1.5 mg/dl * renal plasma creatinine ≤ uln creatinine clearance ≥ 60 ml/min exclusion criteria: * interstitial pneumonia, pulmonary fibrosis * myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure * intestinal paralysis, intestinal obstruction, uncontrollable diabetes

Keywords: stomach cancer
alveolar recruitment maneuvers, intracerebral hemodynamic and oxygenation

Conditions: Cerebral Injuries; Acute Respiratory Distress Syndrome (ARDS)

Summary: this study aims to compare 2 alveolar recruitment maneuvers (arm) in patients with cerebral injuries and acute respiratory distress syndrome (ards) in term of efficacy and tolerance.

two arm are compared in this study: * the esigh or extended sigh with increase of peep for 10 minutes to maintain plateau pressure at 40 cmh2o. during arm, the peak pressure is limited to 50 cm h2o with decrease of tidal volume (vt) if necessary. * the continuous positive airway pressure, or continuous positive airway pressure (cpap) with application of a positive pressure of 40 cm h2o for 40 seconds without tidal volume. patients are randomized to receive in cross-over 2 arm: cpap and extended sigh (esigh). the following data: oxygen tissue partial pressure (ptio2), respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each arm.

Eligibility criteria:
inclusion criteria: * patients with brain injuries (subarachnoid hemorrhage, traumatic brain injury, ischemic and hemorrhagic stroke) * patients with moderate and severe ards criteria (as defined by classification of berlin) * patients under mechanical ventilation exclusion criteria: * icp (intracranial pressure) \> 25 mmhg * pregnant women * patients with history of chronic respiratory disease * patients with bronchopleural fistula * patients with hemodynamic instability despite appropriate measures

Keywords: alveolar recruitment maneuvers (arm) continuous positive airway pressure (cpap) extended sigh (esigh)
medigus ultrasonic surgical endostapler (muse) registry

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: this registry is intended as an observational, post-marketing surveillance tool. the registry allows collection of baseline demographics and user experience of the commercially available muse system. data collection aims to aggregate a minimum of 3 years follow-up on a large number of subjects during use outside the constraints of a prescribed clinical study.

the registry evaluates the muse system which creates a transoral anterior fundoplication for the treatment of gerd. the system enables the operator to staple the fundus of the stomach to the esophagus approximately 3cm superior to the z-line in 2 or more locations. the procedure is performed transorally under general anesthesia. the procedural result is anatomically and functionally similar to standard anterior fundoplication (dor-thal operation). the staples are standard, 4.8mm titanium surgical staples. each application of the device fires a quintuplet of staples (5) in three staggered rows. anti-retching medications at the time of the procedure are essential. the study population will be primarily adults aged 18-70 years selected by the investigators based on sages guidelines for fundoplication and consideration of the indications and contraindications listed in the device instructions for use (ifu). follow-up data will be collected at 6 months, 1, 2 and 3 years post procedure.

Eligibility criteria:
inclusion criteria: generally follow the guidelines for laparoscopic fundoplication published by sages (society of american gastrointestinal and endoscopic surgeons) objective evidence of gerd * positive acid exposure test or endoscopic evidence of esophagitis and * inadequate symptom control or * patient preference from surgery over medications or * extra-esophageal manifestations (asthma, hoarseness, cough, chest pain, aspiration) exclusion criteria: * significant co-morbidity (for example, american society of anesthesiologists grade 3 or higher) * bmi \>35 or \<20 * no response to proton pump inhibitors * grade iv esophagitis * hiatal hernia \>3 cm * irreducible hernia of any size * gastric outlet obstruction * short esophagus * esophageal diverticula, strictures or varices * esophageal motility disorders
evaluating the effects of tasimelteon vs. placebo in treating pediatric insomnia

Conditions: Insomnia Disorder

Summary: this is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.


Eligibility criteria:
inclusion criteria: * ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required). * confirmed clinical diagnosis of insomnia disorder * males and females between 2 and 17 years, inclusive. * the sleep disturbance must not be a result of another medication. exclusion criteria: * inability to dose daily with tasimelteon or previous intolerance to tasimelteon. * indication of impaired liver function. * pregnant or lactating females. * a positive test for drugs of abuse.
study of docetaxel in combination with cisplatin and 5-fluorouracil in locally advanced squamous cell carcinoma of the head and neck

Conditions: Advanced Squamous Cell Carcinoma; Squamous Cell Carcinoma of Head and Neck; SSCHN

Summary: the purpose of this study is to determine the appropriate dose, that dose which is found to give maximum effect with limited toxicity, of cisplatin in combination with docetaxel and 5-fluorouracil and then to further define the safety and effectiveness of this combination of medications.

* treatment begins with a one hour infusion of docetaxel followed by a 1/2 hour infusion of cisplatin. 5-fluorouracil will be administered through continuous iv infusion through a portable pump for four days at home. a cycle is twenty-one days long ( 4 days of chemotherapy and 17 days of recovery). * during each cycle blood tests will be performed weekly. a physical exam will be performed and the impact of the chemotherapy will be assessed at the end of each cycle. * if after 2 cycles the patients cancer has not responded sufficiently they will be removed from the study. * if significant reduction in the size of the tumor is observed after cycle 2, a third and final cycle will be performed. followed by radiation therapy twice daily for approximately 6-7 weeks.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of squamous cell carcinoma of head and neck (sschn). * at least one bi- or uni-dimensionally measurable lesion. * stage ii or iv disease without evidence of distant metastasis. * no previous chemotherapy, radiotherapy or surgery (other than biopsy) for sschn. * age greater than 18 years. * ecog performance status of 0 or 1. * life expectancy of greater than 12 weeks. * adequate bone marrow, hepatic and renal function. * normal serum calcium exclusion criteria: * primary tumor location in nasopharynx, nasal cavity, sinuses, or salivary glands. * patients with any non-sschn malignancy within 5 years of study entry, except curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix. * any prior treatment with chemotherapy. * prior radiotherapy to major bone marrow area (\> 10% bone marrow) or to head and neck. * current peripheral neuropathy of greater than nci grade 2. * other serious illness or medical condition * concurrent treatment with corticosteroids unless chronic treatment at low doses. * pregnant or lactating females or females of childbearing potential not employing adequate contraception.

Keywords: advanced squamous cell carcinoma squamous cell carcinoma of head and neck sschn docetaxel
tdcs and cognitive training combined for aud (tango)

Conditions: Alcohol Use Disorder; Addiction

Summary: the overarching goal of this project is to expand the traditional expertise in non-invasive neuromodulation at the university of minnesota towards developing novel paired-neuromodulation approaches using transcranial direct current stimulation (tdcs) for new treatments for alcohol use disorder (aud) that support long-term abstinence. this study will allow the investigators to discern whether the pairing of dorsolateral prefrontal cortex (dlpfc) stimulation and cognitive training can lead to improved treatment outcomes as it pertains to executive functioning and maintenance of abstinence. this paired-neuromodulation approach can potentially be used as a therapeutic intervention to decrease relapse probability in addiction. the long-term goal is to develop new addiction treatments that support long-term abstinence. the exploratory goal of this research is to associate genotypes and epigenetic changes with variations in intervention response and clinical outcome. individual differences in baseline genetic profiles or epigenetic changes over the course of treatment could be associated with treatment response variability.


Eligibility criteria:
inclusion criteria: * meet the diagnostic and statistical manual of mental disorders diagnostic criteria for aud * abstinent from alcohol use * must have the intention to remain in the lodging plus program until the end of the intervention portion of the study. exclusion criteria: * any medical condition or treatment with neurological sequelae (i.e. stroke, tumor, loss of consciousness\>30 min, hiv) * a head injury resulting in a skull fracture or a loss of consciousness exceeding 30 minutes (i.e., moderate or severe tbi) * any contraindications for tdcs or mri scanning (tdcs contraindication: history of seizures; mri contraindications; metal implants, pacemakers or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or moving disorder) * any primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder); participants with other treated and stable psychiatric disorders will be included * presence of a condition that would render study measures difficult or impossible to administer or interpret * primary current substance use disorder diagnosis on a substance other than alcohol except for caffeine or nicotine * clinical evidence for wernicke-korsakoff syndrome * left-handedness * entrance to the treatment program under a court mandate
clinical efficacy of a toothpaste on hypersensitivity reduction

Conditions: Hypersensitivity

Summary: tooth sensitivity reduction after dentifrices use


Eligibility criteria:
inclusion criteria: * male and female subjects, ages 18-70, inclusive. * availability for the three month duration of the study. * two sensitive teeth, which must be anterior to the molars, and demonstrate cervical erosion/abrasion or gingival recession. * qualifying response to tactile stimuli (yeaple probe) as defined by a score between 10-50gms. of force. * qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the schiff cold air sensitivity scale. * subjects need to satisfy the qualifying response to stimuli for both the parameters assessed (tactile or air) on two teeth to be entered into the study. * good general health with no known allergies to products being tested. * use of a non-desensitizing dentifrice for three months prior to entry into the study. * signed informed consent form. exclusion criteria: * gross oral pathology, chronic disease, or history of allergy to test products. * advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months. * sensitive teeth with mobility greater than one. * teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures. * subjects that began to take anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one month prior to the start of the study or who have to start taking these during the course of the study. * participation in a desensitizing dentifrice study or regular use of a desensitizing dentifrice within the past three months. * current participation in any other clinical study. * pregnant or lactating subjects. * allergies to oral care products, personal care consumer products, or their ingredients. * medical condition which prohibits not eating/drinking for 4 hours.
home therapy with replagal in fabry disease

Conditions: Fabry Disease

Summary: the purpose of this study is to proof increasing patient satisfaction and preservation of quality of life in patients with morbus fabry disease receiving their enzyme replacement therapy with replagal (agalsidase alfa) at home compared to receiving the infusions at the clinic or at doctor's practice.


Eligibility criteria:
inclusion criteria: * male or female patient with a confirmed diagnosis of fabry disease * age\> 4 years * patient is under replagal since at least 12 weeks ® therapy * the patient is compliant, the previous replagal ® infusions were performed approximately every 2 weeks in the center close to home or at the hospital / general practitioner at * patient has been well tolerated replagal ® therapy, and there were in the last 12 weeks before inclusion in this study no significant infusion reactions to * the patient has been selected before inclusion in this study for a home infusion therapy and has consented to (or their legal representative) * the patient / be lawful. representative has consented in writing to participate in this study. exclusion criteria: * patient/legal representative does not give consent to participation in this study * patient/legal representative declines replagal® home therapy * the patient is participating in a clinical trial with a medicinal product

Keywords: patients with proven fabry's disease
investigating attention patterns in young people with anxiety

Conditions: Anxiety; Adolescent Behavior

Summary: adolescents with elevated anxiety have been found to direct their voluntary and involuntary attention more readily toward threatening stimuli, and spend more time dwelling upon that stimuli. various computerised tasks have been developed to attempt to retrain these "attention biases" back away from threat. this study will test a newly developed intervention, that uses (eye-tracking) methods to track the gaze of the individual. this intervention is called gaze-contingent music reward training (gc-mrt), and is designed to re-train the individual away from dwelling upon threatening stimuli (emotional faces), using their favourite music to re-infornce this learning.


Eligibility criteria:
inclusion criteria: * 12-18 years of age upon study commencement * diagnosed generalised or social anxiety disorder (assessed by scid) * informed written and witnessed consent exclusion criteria: * psychosis * autism * learning difficulties * uncorrected abnormal vision * current use of ssris

Keywords: attention anxiety adolescence
a comparison of urinary incontinence during third trimester of nulliparous on pelvic floor muscle training

Conditions: Urinary Incontinence

Summary: comparison of urinary incontinence during third trimester of nulliparous on pelvic floor muscle training in rajavithi hospital

outcomes 1. primary outcome \>\> ui at third trimester 2. secondary outcome \>\> quality of life, duration of second stage of labor * inclusion criteria nulliparous ga 20-24 week gestation singleton age 18-35 years old can communicate and understand thai language cooperating to join research * exclusion criteria dfiu maternal medical condition or high risk pregnancy such as multifetal gestation, chronic hypertension, pregestational dm, epilepsy, autoimmune disease, polyhydramnios asthma * pre-excisting urinary incontinence * prepregnancy bmi\>=30 kg/m2 * smoking * 2 groups study \>\> control and intervention group * both groups were evaluated urinary incontinence(ui) at third trimester with udi-6 and iiq-7 questionaires * intervention group was trianed pelvic floor muscle strength and evaluate strength with brink score by researcher who was trained and tested pelvic floor muscle strength by urogynecologist at day 1 then reassess brink score at 4 weeks * program of pelvic floor muscle training ( pfmt) consist of contract and whole pelvic floor muscle 10 seconds and relaxation 10 second total 20 times per set total 3 set per day * intervention group was followed up once a week by telephone about compliance of program, general symptom and notice for self recording sheet * pfmt program follow up total 12 weeks

Eligibility criteria:
inclusion criteria: * nulliparous * gestational gae 20-24 week * age 18-35 year * can communicate and understand thai language * co-operate to join research exclusion criteria: * dfiu * maternal medical condition or high risk pregnancy such as multifetal gestation , pregestational dm, chonic hypertension , epilepsy, autoimmune disease, polyhydramnios, asthma * pre-excisting urinary incontinence * prepregnant bmi \>=30 kg/m2 * smoking

Keywords: urinary incontinence pelvic floor muscle training nulliparous pregnancy
multicenter study on the toxicity of gluten traces in the treatment of celiac disease

Conditions: Celiac Disease

Summary: the purpose of this study is to evaluate the toxicity of minute doses of gluten in the treatment of celiac disease, a disorder characterized by permanent intolerance to dietary gluten.

treatment of celiac disease (cd) is based on the complete avoidance of gluten-containing products in the diet. however it is not known whether tiny amounts of gluten are harmful for patients on long-term treatment. this is an important issue, as even a strict gluten-free diet (gfd) is usually contaminated by traces of gluten, e.g. in wheat starch and processed food. the aim of this study is to investigate the toxicity of the prolonged ingestion of gluten traces in treated cd patients. this is a prospective, placebo-controlled, double-blind study. patients are adults with biopsy-proven cd on treatment with the gfd for at least 2 years. during the study period their background daily gluten intake is kept lower than 5 mg. after baseline evaluation, patients continue their gfd and are assigned to ingest 0 mg, 10 mg or 50 mg of daily gluten (incorporated in a capsule) for 90 days. the following evaluations are performed both at baseline and after the micro-challenge: clinical, serological (anti-transglutaminase and antigliadin antibodies), and small intestine histology.

Eligibility criteria:
inclusion criteria: adults with biopsy-proven celiac disease on a gluten-free diet for at least 2 years and in apparent good health - exclusion criteria: 1. patients younger than 18 years old; 2. poor compliance to the gluten-free diet; 3. abnormal results at the baseline evaluation (positivity of anti-tissue transglutaminase (ttg) antibodies and/or definitely abnormal small intestinal biopsy; 4. associated conditions, such as selective iga deficiency or other autoimmune diseases -

Keywords: celiac disease gluten toxicity small bowel morphometry