Kornimate/medical-research-clean huggingface dataset:
comprest - a comparison between sleep compression and sleep restriction for treating insomnia

Conditions: Insomnia

Summary: this study includes two consecutive sub-trials. cognitive behavioral therapy (cbt) is treatment of choice for insomnia. one of the most important treatment components in cbt for insomnia (cbt-i) is sleep restriction (sr), but lately, adverse effects related to sr have been reported. a treatment method with similarities to sr is sleep compression (sc). sc is not as well studied as sr, but appears to have similar effects to sr but without the adverse effects. the first sub-trial thus aims at directly comparing sr and sc. the second sub-trial aims at evaluating any additional effects of cbt-i components given as an add-on treatment to a randomized selection of half participants in each original treatment arm.


Eligibility criteria:
inclusion criteria: * clinical level of insomnia (more than 10 on isi) * meets criteria for insomnia disorder according to dsm-v * sufficient language skills * having access to internet to fill out forms and participating in treatment * not foresee obstacles to participating in treatment during the coming 20 weeks, or participating in measurements during the coming year. exclusion criteria: * sleep disorders requiring other treatment * high consumption of alcohol/drugs that affect sleep * somatic or psychiatric conditions counter-indicative of treatments given in the study, requiring acute care, or with symptoms and level of functioning affecting the ability to participate in the treatment programs. * working (night) shifts * ongoing psychological treatment for insomnia with sleep restriction or sleep compression as a treatment component - also previous such treatment can be excluding * use of sleep medication in such a way that may hinder the implementation of the methods in this treatment * pre-treatment measurements not finished within the given time-frame.

Keywords: sleep restriction sleep compression cognitive behavioral therapy
study of nivolumab given sequentially with ipilimumab in subjects with advanced or metastatic melanoma (checkmate 064)

Conditions: Advanced or Metastatic Melanoma

Summary: the purpose of this study is to evaluate the safety and efficacy of a sequential combination therapy of nivolumab and ipilimumab

in order to evaluate the potential synergistic activity of nivolumab and ipilimumab and also because there may be differences in biology between tumors which are stable or responding to therapy and those that are clinically progressing, this study, ca209064, looked at two sequential combination regimens in which the second agent is administered immediately after a pre-specified duration of therapy with the first agent and not delayed until the time of progression after the first agent. this sequential study design looked at pharmacodynamic changes during treatment with one agent which may predict clinical activity to subsequent treatment with the alternate agent. this was done because it has not been scientifically proven whether or not the order in which nivolumab and ipilimumab are given is clinically important.

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * histologically confirmed unresectable stage iii or iv melanoma * treatment-naive or experienced disease recurrence or progression during or after one prior systemic regimen for advanced disease * measurable disease by computed tomography/magnetic resonance imaging (ct/mri) per response evaluation criteria in solid tumors (recist) 1.1 criteria * eastern cooperative oncology group (ecog) performance status 0 or 1 * known braf v600 mutation status or consent to braf v600 mutation testing * sufficient tumor tissue accessible for baseline and post-treatment biopsies. exclusion criteria: * active central nervous system (cns) metastases * carcinomatous meningitis * active, known or suspected autoimmune disease * condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization * prior therapy with anti-programmed death-1 (pd1), anti-programmed death-ligand 1 (pd-l1), anti-pd-l2, anti-cd137, or anti-ctla-4 (cytotoxic t lymphocyte antigen 4) antibody * prior treatment with other immunotherapies * prior therapy with braf inhibitor within 6 weeks of enrollment
application of tdcs stimulation in controlling refractory status epilepticus

Conditions: Refractory Status Epilepticus

Summary: the purpose of the study is to assess the efficacy and safety of targeting tdcs stimulation for treatment of refractory status epilepticus

after being informed about the study and potential risks, the recruited patients, giving written informed consent, will be determined of the eligibility for study entry. the patients who meet the eligibility requirements will be randomized in a 1:1 ratio to undergo targeting tdcs stimulation (up to 10 times) or sham stimulation.

Eligibility criteria:
inclusion criteria: * age between 14 and 80 year-old with gender unlimited, * suitable for eeg monitoring; * clinical diagnosis of refractory status epilepticus (status epilepticus that cannot be controlled by two types of antiepileptic drugs and at least one anesthetic); * informed consent to participate in this study was obtained from the participants or their surrogates exclusion criteria: * unstable vital signs (systolic blood pressure\<90mmhg, heart rate\<60 beats/min, pulse oxygen saturation\<90%); * having severe skull injury/defect or medical equipment implanted in the head; * pregnancy; * with any implantable electronic instrument (including pacemakers, vagus nerve stimulators) or metal implanted devices.
computer assisted total knee replacement

Conditions: Total Knee Arthroplasty; Osteoarthritis

Summary: the purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in total knee arthroplasty (tka).

primary data to be obtained is to determine whether mechanical axis of the limb malignment differs between patients whom have computer-assisted tka and those treated with conventional intraoperative instrumentation. three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including: full length standing, standard ap weight bearing, lateral, patellar, kneelingfilm views and ct evaluation. in addition, a correlation betweeen the ct measures and the kneeling x-ray can be performed at this time. clinical (knee scale society, womac, and sf-36) data will also be obtained at the three month interval.

Eligibility criteria:
study participants must: 1. be over 18 years of age. 2. require a tka and is considered by the investigator to be a suitable candidate for the specific knee prosthesis identified in protocol. 3. the subject has given consent to the transfer of his/her information to the sponsor.
a trial assessing chemo mouthpiece device with best supportive care for symptoms of chemotherapy-induced oral mucositis

Conditions: Oral Mucositis

Summary: this study will compare the use of the chemo mouthpiecetm device along with best supportive oral care to best supportive oral care alone to rate the effectiveness of chemo mouthpiecetm in lessening symptoms associated with chemotherapy regimen known to place patients at risk for symptomatic mucositis and, of those, chemotherapy regimens for which ice-based cryotherapy has been demonstrated to have a favorable impact on oral mucositis symptom management. subjects who are receiving standard chemotherapy regimens will be randomly assigned to receive either study device and oral care ingredients or oral care ingredients only. all subjects will complete daily diaries for the first 14 days of chemotherapy cycles 1 and 2. subjects who are assigned to the study device arm will use the device during their chemotherapy infusion in clinic and will continue to use the device at home ,at least twice daily, for the first six (6) days of chemotherapy cycles 1 and 2. prior to the first chemotherapy infusion in cycle 3, all subjects in the study regardless of treatment assignment will have the option of using the chemo mouthpiecetm for subsequent cycles.


Eligibility criteria:
inclusion criteria: 1. aged 18-80 years 2. planned to receive at least 2 cycles of infused stomatotoxic chemotherapy regimens such as: * cmf (cyclophosphamide (cytoxan), methotrexate, 5-fu) * standard ac+t regimen (doxorubicin (adriamycin), cyclophosphamide (cytoxan), taxane \[paclitaxel (taxol) or docetaxel (taxotere)\]) or any combination of two or more components (e.g., act, tac, ta, at, ac) * abvd (doxorubicin (adriamycin), bleomycin, vinblastine, dacarbazine) * folfiri (irinotecan, 5-fu, leucovorin) * any other 5-fu-based regimen (excluding folfox) 3. be willing and able to complete all study-related activities 4. properly obtained written informed consent exclusion criteria: 1. receiving any oxaliplatin-containing chemotherapy regimen, such as folfox 2. concurrent radiotherapy 3. unable or unwilling to complete study assessments 4. unable or unwilling to avoid using ice chips 5. known allergy to silicone 6. concurrent participation in another interventional clinical study or use of another investigational agent within 30 days prior to randomization 7. any other clinical or psychiatric condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the protocol 8. chronic use of opioid analgesics

Keywords: prospective studies, stomatitis, cryotherapy, patient reported outcome measures
trial of an online spanish pivotal response treatment training in autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: the goal of this clinical trial is to understand if an online course in spanish can help spanish-speaking parents use pivotal response treatment (prt) to support language and social skills in young children with autism spectrum disorder (asd). this study aims to reach families who may have trouble accessing autism services due to language, location, or cost barriers. the main questions it hopes to answer are: * can spanish-speaking parents learn to effectively use prt techniques to support their child's communication? * does this training improve children's language and social interactions? researchers will evaluate the effectiveness of the online course for parents who participate in regular virtual check-ins and submit videos showing their practice with prt. participants in the study will: * complete online lessons over 12 weeks that teach prt methods, specifically designed for spanish-speaking parents * meet with a research team member every few weeks by phone or video to ask questions and receive feedback * provide video recordings of interactions with their child to track progress * complete brief surveys about their experience and child's communication abilities by focusing on spanish-speaking families, this study aims to increase access to effective autism support and reduce gaps in care. researchers hope the findings will help develop better resources for families facing similar barriers and improve language and social outcomes for children with autism.


Eligibility criteria:
inclusion criteria: * children aged 2 to 5 years, 11 months at the time of consent * diagnosis of autism spectrum disorder (asd), confirmed through medical records and/or parent questionnaire * significant language delay, indicated by scores 2 standard deviations (sd) below the average for ages 2 and 3, or 3 sd below the average for ages 4 and 5 on the vineland-3 communication subscale or expressive v-scale * a spanish-speaking parent or primary caregiver available to consistently participate in study activities and implement prt in spanish * stable on any psychotropic medications or biomedical interventions for at least 1 month before baseline, with no anticipated changes during the study * consistent treatment or intervention services (such as aba, floortime, or speech therapy) and stable school placement for at least 1 month before baseline, with no expected changes * limited to no more than 60 minutes of one-on-one speech therapy per week exclusion criteria: * primary language of the child or parent is not spanish * either the child or parent has a severe psychiatric disorder or an unstable medical condition * prior exposure to or adequate trial of pivotal response treatment, resulting in the parent achieving fidelity in prt implementation at baseline * the child is currently receiving more than 15 hours of one-on-one applied behavior analysis (aba) therapy per week
acceptability and feasibility of finger foods

Conditions: Stroke, Acute

Summary: this study will investigate the feasibility of using a finger food menu on an acute stroke rehabilitation ward. this study has a mixed methods design, with quantitative, qualitative and economic components which will be used to inform a future randomised control trial.


Eligibility criteria:
inclusion criteria: * current patient on stroke rehabilitation ward * 65 years or older * normal textured food exclusion criteria: * on the end of life pathway * partial or full enteral feeding * significant food allergies, intolerances or other dietary restrictions that could not be catered for by the finger food menu. * unable to give consent or no consultee able to consent on behalf of patient * in a side room on the ward

Keywords: finger food
association of anthropometrics with grip strength and smash quality post six week elastic resistance training

Conditions: Anthropometric Measurements and Elastic Resistance Training; Sports Physical Therapy

Summary: to determine the association of hand and forearm anthropometrics on grip strength and forehand smash quality of badminton players after six-weeks of elastic resistance training.

as literature suggests that anthropometrics such as bmi and height do affect many game outcomes but specific anthropometrics have not been considered before so it is included in this study. similarly the affects of elastic resistance training for lower limb has been recorded while the literature lacks for upper limb.

Eligibility criteria:
inclusion criteria: * collegiate players of badminton. * players attending at least two training sessions per week for the past one month exclusion criteria: * players having strain or sprain of upper or lower limb within the last months * payers having any cardiovascular, neuromusculoskeletal or other systematic pathology.
prevalence of post-craniotomy headache in siriraj hospital

Conditions: Adult Brain Tumor; Headache

Summary: headache after major craniotomy may be a problem in taking care of the patients. the investigators want to identify the incidence of headache after major craniotomy and also the risk factors.


Eligibility criteria:
inclusion criteria: * patient undergoing major craniotomy exclusion criteria: * emergency surgery or traumatic patients * may need postoperative ventilatory support more than 2 days * cannot communicate * psychiatric patients * chronic use of benzodiazepine or drug abuse * cannot follow the treatment

Keywords: craniotomy headache postoperative
safety, preliminary pharmacokinetics and bronchodilator properties of v0162

Conditions: Chronic Obstructive Pulmonary Disease

Summary: pulmonary administered anticholinergic agents have shown their importance in the chronic obstructive pulmonary disease (copd) management to reduce morbidity, disability and mortality. to date, the recommended treatment of moderate to severe copd patients consist in the combination of ß2 agonist and long acting antimuscarinic compounds. there is still a medical need in new product that could exhibit both anti-inflammatory and strong bronchodilation potency. v0162 is a compound with a potent anticholinergic activity. secondary pd properties of v0162 could enhance the efficacy of this antimuscarinic compound and could bring new option in the treatment of this life-threatening disease.

this study has two parts. part a will be conducted in 72 healthy volunteers. part b will be conducted in 20 patients diagnosed with copd. part a the primary objective of this part of the study is to assess the local tolerability of escalating doses of v0162 in male healthy volunteers. part b the primary objective of this part of the study is to assess the bronchodilator properties of v0162 at the maximal tolerated dose (determined in part a) in copd patients. in addition, pharmacokinetics and vital sign including ecg will be determined.

Eligibility criteria:
inclusion criteria part a: * male gender * age between 18 to 50 years included, * 18 ≤ body mass index (bmi) \< 30 kg/m², * who had given their written consent for their participation in the study, * who, in the judgement of the investigator, are likely to be compliant during the study, * registered with a social security insurance system. inclusion criteria part b: * aged 40 to 65 years-old, * 18 ≤ bmi \< 35 kg/m2, * smokers ≥ 10 packs / year, * moderate to severe copd * registered with a social security insurance system. exclusion criteria part a: * history of asthma or significant respiratory disorder, * history of allergic rhinitis, * upper respiratory tract infection in the last month, * blood eosinophil count ≥ 600/μl, * epilepsy, narrow angle glaucoma, prostatic hypertrophy or bladder neck obstruction, * abnormal spirography, exclusion criteria part b: * respiratory tract infection in the last 6 weeks, * asthma or significant respiratory disorder other than copd, * allergic rhinitis, * blood eosinophil count ≥ 600/μl, * epilepsy, narrow angle glaucoma, moderate to severe prostatic hypertrophy or bladder neckobstruction, * myocardial infarction within the previous 6 months, heart failure or serious cardiac arrhythmia, * moderate to severe renal impairment, * moderate to severe hepatic impairment * use of short-acting b-agonist, * use of anticholinergics

Keywords: copd
first in human study of the infusion of ari0003 cells in relapsed/refractory to treatment b-cell aggressive lymphoma

Conditions: Refractory Non-Hodgkin Lymphoma; Relapsed Non-Hodgkin Lymphoma

Summary: ths study consist in testing a car t therapy (ari0003 cells (anticd19 and antibcma) in patients suffering relapsed nhl (that means that symptoms of nhl reappeared ) or refractory (that means that they did not respond to other treatments). this is a first in human study.


Eligibility criteria:
inclusion criteria: * 1. diagnosis of cd19+ or cd269+ relapsed/refractory (r/r) aggressive b-cell lymphoma in one of the following circumstances: * burkitt's lymphoma; * histology not covered by approved cart19-cell products (plasmablastic lymphoma, primary effusion lymphoma, intravascular lymphoma, transformed lymphoma from marginal zone lymphoma or chronic lymphocytic leukaemia, primary cutaneous dlbcl, t-cell rich dlbcl, high-grade b-cell lymphoma, grey zone lymphoma or grade 3b follicular lymphoma); or * aggressive b-cell lymphoma that is refractory or relapsing after treatment with cart19-cell therapy. 2. age older than 18 years. 3. ecog performance status of 0-2. 4. estimated life expectancy of at least 3 months. 5. adequate venous access and absence of contraindications for lymphapheresis. 6. signature of informed consent. 7. in patients who have received any anti-cd19 or anti-cd269 therapy (e.g. tisagenlecleucel, axicabtagene autoleucel, tafasitamab, loncastuximab, belantamab mafodotin, idecabtagene vicleucel, etc.), a centralised tumour sample confirming the expression of at least one of the antigens (either cd19 or cd269) will be needed at study inclusion exclusion criteria: * 1. any experimental or non-commercialized therapy in the previous 4 weeks. 2. any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma. 3. active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent). 4. active infection requiring systemic medical therapy. 5. active hbv or hcv infection. 6. positive serology for hiv. 7. any concomitant and uncontrolled medical disease. 8. severe organic impairment defined by cardiac ejection fraction \ 3 times the upper limit of normality (unless due to gilbert's syndrome). 9. lactating or pregnant women. 10. men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures from the beginning until the end of the study. 11. cns disease in the form of a macroscopic solid lesion in the encephalon or spinal cord (isolated meningeal disease is allowed
effect of spinal magnetic stimulation on management of functional constipation in adults

Conditions: Functional Constipation

Summary: conservative management of functional constipation is a preferable method including biofeedback and spinal magnetic stimulation sessions

constipation varies in presentation and severity among patients and affects patients' quality of life of varied degrees depending on how it manifests and how severe it is. the prevalence of constipation in the general population is estimated to affect about 20% of the population spinal magnetic stimulation (sms) is a non-invasive, painless neurophysiological treatment that uses extracorporeal magnetic stimulation to direct extracorporeal magnetic stimulation to the spinal nerves and deep muscles to aid bowl evacuation without the use of surgery. this noninvasive approach was created to help with micturition, expiration, and bowel function the aim of this work is to study the efficacy of sms and biofeedback versus biofeedback in the management of functional constipation.

Eligibility criteria:
inclusion criteria: * adults patients diagnosed by rome iv criteria as having functional constipation exclusion criteria: * patients younger than 18 years old. * patients with irritable bowel syndrome. * anal hemorrhoids or bleeding. * any condition that may complicate bowel problems, such as parkinson's disease, stroke, or traumatic brain injury.

Keywords: spinal magnetic stimulation, constipation