Kornimate/medical-research-clean huggingface dataset:
first study with a brain implant to help locked-in patients communicate at home

Conditions: Locked-In Syndrome

Summary: in this study a new means of communication for people with locked-in syndrome will be tested. the investigators will record brain signals directly from the surface of the brain by means of a completely implantable system. these brain signals are fed wirelessly into an assistive technology device and will control this device for communication and environmental control at the users home.

in this pilot study we will provide locked-in people with a new means of communication which has not been possible up to now. for the first time, we will test whether we can record and decode neural signals obtained directly from the brain, for control over a computer. the target population is people with locked-in syndrome. for these patients there is no technique available to allow them to communicate unaided. we have developed a brain-computer interface (bci) system that can read activity directly from the brain, and can convert the activity to a digital switch. the system, called the utrecht neural prosthesis (unp), consists of an implantable amplifier for electrical brain signals, a set of electrodes positioned on the surface of the brain and a wireless receiver, placed outside of the body. a dedicated computer will convert the signals to electrical pulses for standard assistive technology devices. the unp can in principle enable the patient to engage in any activity that is offered by commercial assistive technology companies that can be performed with switch signals, for instance operating home apparatus or writing text. most importantly, we aim to achieve unsupervised function of the bci, meaning that the patient will be able to use it at home without the aid of researchers or other experts (but with minimal caregiver assistance).

Eligibility criteria:
inclusion criteria: * age 18 - 75 * locked-in status (i.e. severely paralyzed with communication problems) * in case of trauma or stroke: at least 1 year after the event * in case of a neuromuscular disease: slow progression allowed * rudimentary form of communication possible (e.g. through assistive technology, eye blinks or eye movements, severely impaired speech) * mentally and physically capable of giving informed consent * lives in or close to the netherlands * mr compatible * able to lie flat in the scanner * no metal objects in or attached to the body * no claustrophobia * visus (largely) intact * cognition intact (iq\>80) * compatible with implantation procedure * good respiratory function or stable respiratory situation using ventilation assistance exclusion criteria: * strong and frequent spasms * vital indication for blood thinners * current brain tumor or history of tumor resection * quick medical or neurological deterioration * patients who are considered legally incapable (and who therefore will not be able to give informed consent) * current or recent psychiatric disorder * catabolic state * allergy to the materials of the implant

Keywords: brain-computer interface motor cortex dorsolateral prefrontal cortex quality of life
real world clinical outcomes of resected alk-positive early stage nsclc patients treated with alectinib as adjuvant therapy

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this study is a multicenter, prospective, cohort study designed to evaluate the clinical outcomes and characteristics of resected stage ii-iiib anaplastic lymphoma kinase (alk)-positive non-small-cell lung cancer (nsclc) adult patients treated with alectinib as adjuvant therapy in china.


Eligibility criteria:
inclusion criteria: * histologically-confirmed stage ii-iiia or selected iiib (t3n2) nsclc as per the american joint committee on cancer and international union against cancer (uicc/ajcc), 8th edition * alk positive * postoperative nsclc patients who have undergone complete resection * had taken alectinib monotherapy without prior systemic therapy (including other alk-tkis or chemotherapy) as adjuvant† therapy for resected stage ii-iiib alkpositive nsclc and the time from the first dose to enrollment was no more than 28 days exclusion criteria: * patients participating in interventional study of adjuvant treatment * pregnant, lactating, or breastfeeding women
investigation of the effects of temporal adaptation approach in post-discharge stroke individuals

Conditions: Stroke

Summary: abstract introduction: stroke is a disease that makes it difficult to participate in daily life activities by creating functional losses. healthy temporal adaptation can increase and support engagement in meaningful activities. this study aims to analyze the effect of the temporal adaptation approach on the post-discharge occupational engagement of individuals with stroke. methods: this study is a randomized controlled trial with 1 month follow-up. while the taa approach was applied to the first group, the general condition of the second group was followed during the study. canadian occupational performance measue was administered to assess occupational performance and satisfaction, and occupational balance questionnaire was for occupational balance. kewords: time, stroke, rehabilitation, human activities, participation


Eligibility criteria:
inclusion criteria: * the inclusion criteria used for this study are as follows: being in the chronic phase of the stroke disease (˃6 months) and score of ˃26 on the montreal cognitive assessment (moca). exclusion criteria: * exclusion criteria used are as follows: diagnosis of a psychiatric illness strongly affects the participation to daily life activities according to medical reports (such as schizophrenia or bipolar disorder), a physical condition other than stroke that requires medical follow-up (fracture, osteoporosis, etc.) and aphasia that would affect the intervention via interview

Keywords: rehabilitation, human activities, participation
myo-inositol as pretreatment in hyperandrogenic pcos patients

Conditions: PCOS; Female Infertility

Summary: a randomized controlled trial to evaluate whether pretreatment with myo-inositol can lower testosterone levels and improve clinical outcomes in hyperandrogenic pcos patients undergoing art


Eligibility criteria:
inclusion criteria: * women aged 18-40 years * pcos phenotypes a, b and c * signed informed consent exclusion criteria: * other relevant endocrine disorders * contraindications to the use of gonadotropins * endometriosis grade 3-4 * bmi \> 35
the effect of whitening toothpaste on tooth color associated with bleaching process

Conditions: Tooth Discoloration

Summary: this double-blind randomized controlled clinical trial aimed to investigate the effect of whitening dentifrices on the clinical efficiency of in-office tooth bleaching procedures.

sixty-three eligible participants (29 males and 34 females, mean age 26.1 years) with at least one maxillary tooth demonstrating shade a3 or darker will be recruited and randomly allocated into 3 groups (n = 21), according to the different dentifrices used in this clinical trial: crest total (regular dentifrice) for group c, crest 3d whitening (conventional whitening dentifrice) for group cw, and close up white now (whitening dentifrice containing blue covarine) for group cu. all participants will receive in-office tooth bleaching with 40% hydrogen peroxide (opalescence boost pf 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). the participants will be instructed to use only the provided dentifrices and toothbrushes to brush their teeth twice daily over a 4-week period. colour parameters (cie l\*, a\*, b\*) will be measured with a spectrophotometer (vita easyshade advance 4.0) at baseline (t1), after the first bleaching session (t2), after the second bleaching session (t3), 1 week after the completion of in-office bleaching (t4), and 3 weeks after the completion of in-office bleaching (t5). the colour differences (δe) and whiteness index (w) will also be calculated. the data will be statistically analysed through repeated anova and tukey's test (α = 0.05).

Eligibility criteria:
inclusion criteria: * patients between 18 and 60 years of age, with fully erupted upper and lower incisors and canines without dental or periodontal disease or restorations, and with at least one maxillary tooth presenting color score a3 or darker, as measured with the vita classical guide (vita zahnfabrik, bad sa ̈ ckingen, germany) ordered by brightness exclusion criteria: * patients with systemic diseases or oral mucosal disorders, previous bleaching treatment, patients undergoing orthodontic treatment, pregnant women, people with known allergy to the product ingredients, smokers, and alcohol abusers.

Keywords: tooth bleaching dentifrice
evaluating light therapy for treatment of overuse anterior knee pain

Conditions: Anterior Knee Pain Syndrome

Summary: during basic training, 15% of military recruits develop knee pain, which hinders their chance to complete training. current therapeutic options have had variable levels of success. light therapy was shown to reduce pain in chronic inflammatory related knee pathology. the current clinical study is designed to evaluate light therapy, as an adjunct to conservative physiotherapy for treatment of acute overuse kp in combat soldiers.

during basic training, 15% of military recruits develop knee pain on the background of overuse, which hinders their chance to complete training, and leads to high dropout rate with the accompanying cost to the system. when kp is due to overuse, the time to complete resolution is typically 2-3 months, but symptoms may last for years. current therapeutic options have had variable levels of success. finding an alternative non-drug, non-invasive therapeutic modality that is easily incorporated in a field setting and may shorten the resolution of pain may lead to earlier return to duty thereby reducing the associated cost to the system and to the individual soldier. low-level laser irradiation (llli) is non-ionizing and non-thermal, and is within the visible to near-infrared range of the electromagnetic spectrum. llli has been used widely for alleviation of pain, reduction of inflammation, and acceleration of wound healing. pre-clinical and clinical studies have shown that llli reduces pain in chronic inflammatory related knee pathology. however, little is known about the effect of llli on acute knee pathology that account for 25-40% of all knee problems in athletes. the current study is a prospective, randomized, controlled double blind clinical study designed to evaluate light therapy, as an adjunct to conservative physiotherapy for treatment of acute overuse kp in combat soldiers. the treatment protocol includes conservative physiotherapy and in addition, biweekly sessions of light therapy or sham irradiation for 4 weeks. two follow up visits will take place at 1 week and 3 months after the last treatment. study evaluations will include physical examination, physical activity tests, subjective pain level by visual analogue scale, improvement and satisfaction scores, and functional questionnaires.

Eligibility criteria:
inclusion criteria: 1. age: 18 - 65 2. knee pain on the background of overuse as determined by the orthopedic surgeon 3. willing to sign informed consent exclusion criteria: 1. previous trauma to the knee 2. previous or planned surgical treatment to the knee 3. suspected meniscus injury 4. suffering from significant concurrent illness, such as cardiac disorders, or pertinent neurological disorders. 5. suffering from condition that does not permit filling questionnaires 6. use of nsaids during the 2 weeks before the development of knee pain or before receiving treatment.
the need for compression bandage following total knee arthroplasty a prospective randomized controlled trial conducted in simultaneous bilateral total knee replacements

Conditions: Osteo Arthritis Knee

Summary: the purpose of this study is to evaluate if applying a compression bandage on the leg alters early outcome following tka. the primary objective of this study is to evaluate leg swelling by measuring leg circumference following simultaneous bilateral total knee arthroplasty (tka) with and without the application of compression bandage.


Eligibility criteria:
inclusion criteria: * all patients receiving elective simultaneous bilateral primary total knee arthroplasty, treated by rothman physicians at the thomas jefferson university hospital or rothman specialty hospital. exclusion criteria: * previous venous thromboembolic event. * lymph edema in one or both legs. * bmi \> 40 * prior surgery (other than arthroscopy)
world data on ambroxol for patients with gd and gba related pd

Conditions: Gaucher Disease; Parkinson Disease; GBA Gene Mutation

Summary: ambroxol hydrochloride is an oral mucolytic drug available over-the-counter for many years as cough medicine. in 2009 it was found to also act as a pharmacological chaperone (pc) for mutant glucocerebrosidase, albeit in a several-fold higher dose. unfortunately, due to its low cost, there have been no pharma-driven clinical trials to establish the use of ambroxol. thus, data are needed on the safety and efficacy of ambroxol for patients with gaucher disease (gd).

the three decades of success of enzyme replacement therapy (ert) for patients with type 1 gaucher disease (gd1) have been just a partial success to those patients with the more severe neuronopathic forms, particularly the children with myoclonic epilepsy or the infants with type 2 gd. ambroxol hydrochloride is an oral mucolytic drug, available over-the-counter (otc) for many years as cough medicine. in 2009 it was found (in-vitro) to also act as a pharmacological chaperone (pc) for mutant glucocerebrosidase (gcase), albeit in a several-fold higher dose . unfortunately, due to its low cost, there have been no pharma-driven clinical trials to establish the use of ambroxol. in an attempt to provide the proof of concept to the potential use of ambroxol as pc for patients with gd, the gaucher clinic at shaare zedek medical center in jerusalem, israel, has treated 12 adult patients with gd1, all untreated with any specific treatment for gd \[whether ert or substrate reduction therapy (srt),\] with ambroxol at the otc dose of 150mg/day for a period of 6 months; this was not a formal clinical trial, but rather an audit of a series of patients receiving this drug via the employment of the israeli ministry of health form 29c to prescribe it for an off-label indication. a single patient, the thinnest of the group with a bmi of 17.1, achieved a robust response relative to baseline similar to ert. in 2016, a group from japan has demonstrated impressive neurological response using high-dose ambroxol (a marked decrease in seizure frequency, improvement of myoclonus, ability to walk for a bedridden patient, improvement in the latency of i-v waves and threshold of abr) with dramatic change in daily activities and quality of life (qol). these encouraging results, that were confirmed in a larger series, yet unpublished, have further led to the conduction of an investigator-initiated-research (iir) clinical trial in london by prof a schapira, which has recently been published (january 13, 2020 jama neurology), wherein newly diagnosed parkinson patients received high dose ambroxol, with good safety results

Eligibility criteria:
inclusion criteria: * patients with gaucher disease type 1,2 or 3(a,b,c). * patients with gba-related parkinson disease. exclusion criteria: * none.

Keywords: ambroxol gaucher disease gba carriers with parkinson disease
partnering with autistic adults to improve healthcare

Conditions: Autism Spectrum Disorder

Summary: the goal of this proposal is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (pcps).

the goal of this study is to develop and evaluate patient-centered care tools for autistic adults and their primary care providers (pcps). one tool will allow autistic adults and/or their supporters to provide individualized information to pcps about how being on the spectrum affects their healthcare and possible strategies to facilitate quality care. another tool will capitalize on the power of patient narrative to educate pcps about autism. these tools and other resources will be housed on an interactive website for autistic adults, supporters, and pcps. the research team will evaluate the feasibility and acceptability of using the new web-based patient-centered care tools with autistic adults and their primary care providers. this study will provide data for a future trial testing the effectiveness of these tools in improving the health of autistic adults by increasing patient-centered care and patient activation.

Eligibility criteria:
inclusion criteria: * medical diagnosis of autism spectrum disorder (including autistic disorder, asperger's disorder, childhood disintegrative disorder, and pervasive developmental disorder nos) * understands written or spoken english or has a support person available who understands written or spoken english * has a primary care provider exclusion criteria: * is not a resident of the united states

Keywords: autism spectrum disorder primary care services patient-provider communication adults
trans-catheter arterial embolization combined with p53 gene therapy for treatment of advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma (HCC)

Summary: an open-labeled, randomized, active-controlled phase ii study to investigate clinical efficacy and immunoreaction using trans-catheter arterial embolization (tae) combined with p53 gene therapy in treatment of advanced hepatocellular carcinoma (hcc).

treatment options for advanced hcc are limited due to patients' poor condition, advanced stage, concomitant intra- and extra-liver diseases, and resistance to both chemo- and radio-therapy. trans-catheter embolization (tae) is a safe locoregional treatment for advanced hcc and p53 gene has multiple anticancer functions, and both methods do not have immune-inhibitory effects as chemo- or radio-therapy. the objectives of this study are to investigate clinical efficacy and immunoreaction usingtae plus recombinant adenoviral human p53 gene (rad-p53) in treatment of advanced hcc.

Eligibility criteria:
inclusion criteria: * histopathologically diagnosed unresectable hcc * over 18 years old * with an eastern cooperative oncology group (ecog) score of 0-2 * with barcelona clinic liver cancer (bclc) stage of b or c * with child-pugh score a or b; with normal tests of hemogram, blood coagulation, liver and kidney function * signed the informed consent form. exclusion criteria: * hypersensitive to study drug * with an abnormal coagulation condition or bleeding disorder * infections * with serious conditions which prevent using the study treatment * pregnant or lactating
postoperative pain in the surgical treatment of hemorrhoids: conventional hemorrhoidectomy with a monopolar electric scaler vs bipolar energy with caiman® (aesculap®)

Conditions: Hemorrhoid Pain; Hemorrhoidectomy

Summary: to demonstrate that postoperative pain secondary to milligan and morgan hemorrhoidectomy with caiman® (aesculap®) and subsequent oral conventional analgesia is at least not greater than that generated after hemorrhoidectomy with monopolar diathermy and intravenous analgesia with care home at discharge.

in the treatment of coloproctological pathology, one of the most important problems is postoperative pain. especially in the management of hemorrhoids treatment. there are different approaches but in all of them pain is the predominant symptom. there are some less painful techniques but the gold standard continues to be hemmorrhoidectomy, which is associated with postoperative pain. some actions have been taken to control pain to avoid the admission of patients, but there are still problems in this regard. our group aims to study the effect of energy change for performing hemorrhoidectomy on postoperative pain.

Eligibility criteria:
inclusion criteria: * all patients with 2 or 3 bundles of grade iii-iv hemorrhoids (goligher classification) clinically symptomatic and subject to outpatient hemorrhoidectomy * voluntary participation. * asa i-ii-iii. exclusion criteria: * failure to meet the inclusion criteria. * asa iv. * allergic to paracetamol, derivatives of morphine. * allergic to nsaids. * synchronous colorectal neoplasia. * coagulation disorders. * thrombosed hemorrhoid. * inflammatory bowel disease. * liver cirrhosis and/or portal hypertension. * pregnant women. * difficulty following up by phone and/or in person.
global open-label extension study of del-desiran for the treatment of dm1

Conditions: Myotonic Dystrophy Type 1; DM1; Myotonic Dystrophy; Myotonia; Myotonic Dystrophy 1; Myotonic Disorders; Steinert Myotonic Dystrophy; Steinert&#39;s Disease

Summary: a global phase 3 open-label extension study to assess the long-term safety, tolerability, and efficacy of intravenous delpacibart etedesiran (abbreviated del-desiran, formerly aoc 1001) for the treatment of myotonic dystrophy type 1

the study consists of a screening period of up to either 4-weeks or 8-weeks depending on the prior parent trial, and up to a 4-year treatment period. the anticipated duration is 50 months and 2 weeks (4 years and 2.5 months). participants will receive an intravenous infusion of del-desiran at the clinical study site every 8 weeks for a total of 7 doses per year. the final dose will occur at year 4, visit 7, followed by a final assessment 8 weeks after the last dose. an independent data monitoring committee (idmc) comprised of members independent and external to the sponsor will review safety, tolerability, and efficacy (as needed) data of this study at regular intervals.

Eligibility criteria:
key inclusion criteria: * completion of any prior aoc 1001 studies with satisfactory completion of dosing and follow-up assessments and satisfactory compliance with the protocol requirements of the parent study, as determined by the investigator. key exclusion criteria: * breastfeeding, pregnancy, or intent to become pregnant during the study. * unwilling to comply with contraceptive requirements. * any new conditions or worsening of existing condition that in the opinion of the investigator would make the participant unsuitable for the study.

Keywords: dm1 myotonic dystrophy myotonic dystrophy 1 myotonia myotonic dystrophy type 1 (dm1) dystrophy myotonic myotonic disorders steinert disease steinert myotonic muscular dystrophy harbor-ole avidity biosciences avidity aoc 1001 del-desiran delpacibart etedesiran harbor
multiplex strip polymerase chain reaction for diagnosis of eye infection diseases from corneal scraping samples

Conditions: Endophthalmitis; Keratitis; Corneal Ulcer; Eye Infections

Summary: the aim of this study is to see if multiplex strip pcr will detect the pathogen that causing eye infection from the corneal scraping samples with higher sensitivity and specificity than the current gold standard.


Eligibility criteria:
inclusion criteria: * registered as new patients since july 2019 in rscm kirana * age more than 18 years * have an eye infection (keratitis, endophthalmitis and corneal ulcer) which required corneal scrapping sampling for further diagnosis exclusion criteria: - not willing to become the participants by not filling the informed consent

Keywords: multiplex solid-phase strip pcr eye infections endophthalmitis corneal ulcer keratitis corneal scraping samples