Kornimate/medical-research-clean huggingface dataset:
a non-invasive neuromodulation device for prevention of episodic migraine headache

Conditions: Intervention

Summary: this study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.

this study is a multi-center, triple-blinded, placebo-controlled, randomized clinical trial for adjunctive prophylactic treatment of episodic migraine headache (with or without aura) using neuromodulation device developed by scion neurostim, llc (sns). the investigational use of the device for episodic migraine headache has been reviewed by the fda and is classified as nsr (non-significant risk).

Eligibility criteria:
inclusion criteria: * diagnosed with episodic migraine at least 6 months before study * at least 3 consecutive months of stable migraine headaches before study * at least 4-14 headache days per month, of which 4-14 may be migraines * must not have failed on more than 2 classes of migraine preventatives exclusion criteria: * previous use of the experimental device * pregnant * using more than 1 concurrent migraine preventive * history of cardiovascular disease * work night shifts * diagnosed with vestibular migraine * menstrual migraines exclusively * diagnosed with post-traumatic migraine * have a history of unstable mood or anxiety disorder * use a hearing aid * have a cochlear implant * have chronic tinnitus * have temporomandibular joint disease * diagnosed with traumatic brain injury * diagnosed with neurological disease other than headaches * diagnosed vestibular and/or balance dysfunction * history of abusing alcohol or other drugs * are experiencing medication overuse headaches * have had eye surgery in the previous 3 months * have had ear surgery in the previous 6 months * have active ear infections or a perforated tympanic membrane * have participated in another clinical trial in the last 30 days * are currently participating in another clinical trial * using botulinum toxin-based treatments for migraines or cosmetic reasons * taking anti-emetics more than 2 times per week (consistently)

Keywords: migraine headache, episodic
low dose peginterferon-α 2a for chronic hepatitis c, genotypes 2 or 3, in hiv-coinfected patients

Conditions: Hepatitis C, Chronic; HIV Infections

Summary: hypothesis: a regimen of low dose of peginterferon alfa-2a plus ribavirin may be as effective as currently recommended regimen for chronic hepatitis c in hiv-coinfected patients. objective: to evaluate the efficacy of lower dose of pegylated interferon-α 2a (135 µg weekly) plus ribavirin and a shorter duration of treatment (20 weeks after achieving an undetectable plasmatic hcv-rna)than the current recommended in patients with chronic hepatitis or compensated cirrhosis by hepatitis c virus, genotypes 2 or 3, in hiv-coinfected patients in real use conditions. method: phase iv, postautorization, open labelled multicenter trial with a planned duration of 118 weeks in which 71 patients from several hospitals of the servicio andaluz de salud will be enrolled. the usual clinical and analytical follow up will be performed but additional blood samples will be obtained for determination of interferon and ribavirin plasma levels. the primary end point wall be a sustained virologic response (defined as an undetectable serum hcv-rna after 24 weeks after the cessation of treatment). likewise, rapid virological response (at 4 weeks of treatment), early virological response (at 12 weeks), and end of treatment response rates will be evaluated as well as their relationships with the plasma interferon an ribavirin concentrations determined by elisa and hplc, respectively. the safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.


Eligibility criteria:
inclusion criteria: * age older than 18 years * hiv infected, diagnosed with chronic hepatitis or compensated cirrhosis by hepatitis c virus (both anti-hcv antibodies and hcv rna levels detectable in serum) not previously treated. * women of child-bearing age: negative pregnancy test * ability to understand and sign a written consent form exclusion criteria: * previous interferon treatment * pregnancy or breastfeeding * acute or chronic hepatitis b infection (positivity for hepatitis b surface antigen or plasma dna) * creatinine clearance \< 50 ml/min, according to cockcroft-gault * decompensated liver disease * history of organ transplantation * concomitant treatment with immunomodulators or didanosine * alcohol abuse or use of other recreational drugs * history of severe psychiatric conditions * autoimmune diseases * inability to understand and sign a written consent form

Keywords: hcv/hiv-coinfected patients peginterferon alfa-2a
prc-063 adult laboratory classroom study in adults with attention-deficit/hyperactivity disorder (adhd)

Conditions: ADHD

Summary: this is a randomized, double-blind, parallel group, placebo-controlled, dose optimized, phase 3 study to evaluate the safety and efficacy of prc-063 in the treatment of adhd in adults


Eligibility criteria:
inclusion criteria: 1. males or females 18 to 60 years of age 2. diagnosis of adhd (any type: combined, predominately hyperactive impulsive type or predominately inattentive type) by a psychiatrist, psychologist, or licensed allied healthcare professional 3. subject is willing and able to comply with all the protocol requirements. exclusion criteria: 1. primary and/or comorbid psychiatric diagnosis other than adhd 2. has a current or recent history of hypertension, symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug; 3. has used any investigational drug within 30 days of the screening visit;
effectiveness of telerehabilitation on subacromial pain syndrome

Conditions: Subacromial Pain Syndrome

Summary: the aim of this study is to evaluate the effectiveness of supervised exercise therapy with active soft tissue and joint mobilization. the effectiveness of telerehabilitation- active mobilization and exercises in the evaluation of pain and function in patients with subacromial pain syndrome will be examined and compared with face-to-face treatment, which is passive manual therapy.

shoulder pain is common in the population. various treatment modalities are used. due to the coronavirus disease (covid-19), the problems in patients' access to hospitals and rehabilitation services caused telerehabilitation to be on the agenda. telerehabilitation can be summarized as the delivery of rehabilitation services to those in need by using communication technologies. this method covers the steps of evaluation, monitoring, prevention, intervention, control, training, and consultation. in addition, as a new treatment application, its effectiveness will be measured in patients with shoulder pain.

Eligibility criteria:
inclusion criteria: * individuals between the ages of 18-50 who complain of shoulder pain * individuals diagnosed with a partial tear of the rotator cuff smaller than 1 cm and as a result of the examination performed by the physician stage 1 or 2 subacromial impingement syndrome. * two of the following tests are positive hawkins-kennedy, painful arc or infraspinatus muscle strength tests * presence of shoulder pain lasting longer than 6 weeks that limits activity. * being literate and not having cognitive dysfunction. exclusion criteria: * presence of other orthopedic, neurological and systemic problems affecting the neck, shoulder and back complex, * patients with heart failure and using a pacemaker, * labral tears and other intraarticular structural pathologies * signs of adhesive capsulitis * grade 3 or full thickness rotator cuff tear * bmi̇ \> 30 kg/m * having been included in a physical therapy program related to the same side shoulder joint in the last 1 year * using non-steroidal anti-inflammatory drugs.

Keywords: pain functionality patient satisfaction
a long-term follow-up study of participants with cystinosis who previously received ctns-rd-04

Conditions: Cystinosis

Summary: this is a multinational, long-term follow-up study to assess the long-term safety and durability of ctns-rd-04 treatment in participants who received a single dose administration of lentiviral gene therapy. no investigational product will be administered in this study. participants will continue periodic safety and efficacy assessments in this long-term follow-up study up to 15 years from the initial date of ctns-rd-04 infusion.

participants enrolled in a study where the individual received ctns-rd-04 will be offered participation in the ctns-rd-04-ltf01 study. the baseline visit for the ctns-rd-04-ltf01 study will likely coincide with the final visit in the parent study. participants confirmed eligible for the ctns-rd-04-ltf01 study will be asked to return for study visits at approximately 6-month intervals for the first 4 years and annually thereafter for up to 11 years until a total of 15 years have elapsed during which time continued safety, engraftment, and efficacy of ctns-rd-04 treatment will be assessed.

Eligibility criteria:
inclusion criteria: • participant must have received ctns-rd-04 in a preceding study exclusion criteria: • participant is currently enrolled in an ctns-rd-04 treatment study. participants who have either completed, withdrawn, or prematurely discontinued participation for any reason at any time after receiving ctns-rd-04 are eligible for ctns rd 04 ltf01 study participation.

Keywords: cystinosis disease cell therapy gene therapy long-term follow-up
meditation, mindfulness, and yoga to reduce perceived stress in resident doctors - a randomized controlled trial with crossover design

Conditions: Stress, Job

Summary: general practitioners perceive their work as meaningful. however, according to a report from the swedish medical association in 2022, about a quarter had considered leaving the profession altogether and nearly half had considered changing workplaces or reducing their working hours during the past 12 months. several studies on mindfulness, yoga and meditation have shown effect on stress and burn out symptoms. the aim of the study is to investigate whether a specially designed 6-week program incorporating meditation, mindfulness, and yoga, tailored to address specific challenges that resident doctors may face in their daily work, can reduce perceived stress levels compared to a control group.

the study is designed as a randomized controlled trial with a crossover design. the outcome measure is the level of stress assessed using the perceived stress scale (pps), swedish version (pss 14). inclusion criteria are resident general practitioners in skåne, within the preliminary catchment area of malmö trelleborg, who have experienced any form of stress symptoms they believe are related to their work. participants will be recruited through an oral presentation during an educational seminar in spring 2024. those who are interested will get a link to a webb-based questionnaire where they can fill in their informed consent and contact information. participants will be randomised to intervention (i) or waiting list (c). the interventions lasts for 6 weeks and consists of a 6 different mindfulness/ meditation/yoga-sessions (lasting for 20 minutes each). the sessions will be sent to the participant on usb-stick or via webb-link. each of the 6 sessions are tailored to address a specific challenge that resident doctors may face in their daily work. the preliminary themes that will be addressed are 'handling mistakes,' 'letting go of work,' 'setting boundaries,' 'taking breaks,' 'being good enough,' and 'managing work stress. the participants are encouraged to perform the program at least 3 times/week. both groups will fill in the pss-questionnaire at study start and after 6 weeks. the control group will start the intervention after the second questionnaire (week 7-12) and will fill out the pss-questionnaire a third time after intervention completion. the results will be analysed according to intention to treat. the mann-whitney u-test will be used to compare whether there is a significant difference in the change of median values on pss 14 between the intervention and control groups.

Eligibility criteria:
inclusion criteria: * resident doctor in primary care having felt work related stress at any time exclusion criteria: * none

Keywords: yoga mindfulness meditation
change of circulating tumor cells during laparoscopic or transanal endoscopic surgery for rectal cancer.

Conditions: Rectal Neoplasms; Neoplastic Cells, Circulating; Laparoscopic Surgery; Transanal Endoscopic Surgery

Summary: the primary purpose of this study is to compare the changes of circulating tumor cells (ctcs) at different time points in rectal cancer patients undergoing laparoscopic or transanal endoscopic radical resection. our secondary purpose is to explore the effects of perioperative circulating tumor cells on tumor recurrence and metastasis.

mid-low rectal cancer is one of the common malignant tumors and the incidence has increased significantly in recent years. at present, surgery is still the most important and effective method for the treatment of mid-low rectal cancer. traditional laparoscopic surgery and emerging transanal total mesorectal excision (tatme) are the main methods. more than one-third of rectal cancer patients will eventually occur local recurrence and distant metastasis, which are the most important factors affecting prognosis. circulating tumor cells may lead to distant metastasis, so the detection of ctcs in blood has important clinical significance in predicting the recurrence and metastasis of rectal cancer and monitoring treatment response. due to the different degrees of contact between distinct surgical methods, this may lead to an increase in the quantity of ctcs in the blood, which may affect the prognosis of patients. therefore, the investigators conducted a randomized controlled study to compare the changes in the quantity of ctcs in the central vein before, during and after operation in rectal cancer patients undergoing transanal endoscopic or laparoscopic radical resection. to explore the effect of two surgical methods on the risk of micrometastasis, and to provide evidence for the selection and improvement of rectal cancer treatment.

Eligibility criteria:
inclusion criteria: 1. mid-low rectal cancer. 2. single lesion. 3. no metastasis. 4. clinical stage t2-3, n0-1. exclusion criteria: 1. history of malignant tumors. 2. acute bowel obstruction, bleeding or perforation. 3. received neoadjuvant treatment. 4. tumor over 6cm in diameter or in severe adhesion with surrounded tissues. 5. severe other contradictions of surgery. 6. pregnant women will be excluded. exit criteria: 1. the patient suffered from massive hemorrhage. 2. the operation mode needs to be changed according to the patient's condition.

Keywords: rectal cancer ctcs
diagnostic performances of computed tomographic coronary angiography and intravascular ultrasound

Conditions: Diagnosis Coronary Artery Disease

Summary: diagnostic purposes of the coronary angiography is to detect stenosis (anatomy) and to detect ischemia related stenosis (function). coronary angiography (cag) is a gold standard invasive techniques, but has several limitations. intravascular ultrasound (ivus) provides tomographic intra-luminal images. coronary computed tomographic angiography (ccta) is helpful to assess precise anatomical information. optimal functional criteria and their accuracy of ivus and ccta by fraction flow reserve (ffr) have not been compared yet.

correlation between ccta, ivus and ffr will be evaluated. the presence of myocardial ischemia will be assessed by fractional flow reserve (ffr). diagnostic performance (sensitivity, specificity, positive predictive/negative predictive values and diagnostic accuracy) of each modality will be assessed and compared.

Eligibility criteria:
inclusion criteria: * patients presenting chest pain suspected stable angina or unstable angina * patients permit informed consents * patients performed all the procedures including ccta, ivus and ffr and present coronary artery stenosis exclusion criteria: * acute myocardial infarction * ejection fraction less than 40% * infarct related artery * chronic renal insufficiency * left main stenosis, in-stent restenosis and grafted vessels * allergy in contrast agent and adenosine * unable to get a informed consents

Keywords: computed tomography intravascular ultrasound coronary stenosis fractional flow reserve
randomized evaluation of aggressive or moderate lipid lowering therapy with pitavastatin in coronary artery disease (real-cad)

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the prevention of cardiovascular disease by moderate cholesterol lowering therapy, pitavastatin 1mg/day or aggressive cholesterol lowering therapy, pitavastatin 4mg/day in patients with stable coronary artery disease.

it was already demonstrated by previous clinical trials that statins lower the incidence of death and cardiovascular events in patients with coronary artery disease. however, whether aggressive cholesterol lowering therapy, using high dosage of statins, is more effective than moderate cholesterol lowering therapy for the prevention of cardiovascular events in patients with coronary artery disease has not been studied in japan.

Eligibility criteria:
inclusion criteria: * patients who met following all criteria are entered in run-in period, loading pitavastatin 1 mg/day for more than 1 month when informed consent was given. (primary registration) * coronary artery disease patients meeting one of the following events * history of acute coronary syndrome (ami or unstable angina) * history of revascularization (pci or cabg) * diagnosis of ischemic heart disease and coronary artery stenosis as having 75% or higher stenosis according to the aha classification * hypercholesterolemia patients meeting one of following criteria * ldl-c is 140 mg/dl or over * ldl-c is 100 mg/dl or over and requiring cholesterol lowering drugs judged by attending physicians * patents receiving cholesterol lowering drugs * age (≧20 \<80 year-old) * patients given written informed consent. exclusion criteria: exclusion criteria(pre-run-in period) * patients planning revascularization * malignant tumor in active phase * patients who meet contraindication of livalo tablet below * patients who have hypersensitivity to livalo tablet * patients who have severe liver dysfunction or biliary atresia * patients who are being treated with cyclosporine * pregnant women, women suspected of being pregnant, or lactating women * patients who have heart failure nyha iii or greater * patients undergoing dialysis * patients with familial hypercholesterolemia * patients registered in the other clinical trials * patients taking prohibited drugs * patients who are ineligible in the opinion of the investigator exclusion criteria(post-run-in period) * ldl-c is 120mg/dl or over after run-in period * patients with occurrence of acute coronary syndrome (ami or unstable angina) within 3 months * patients who have been undergone pci or cabg within 3 months * compliance is less than 50% in run-in period * patients who met primary endpoint in run-in period. * patients who met adverse events in run-in period and judged as ineligible in the opinion of the investigator * patients who are ineligible in the opinion of the investigator

Keywords: pitavastatin coronary artery disease cardiovascular disease
nutrition in pediatric oncology in central america

Conditions: Nutrition in Cancer Survival and Treatment

Summary: this study investigates nutritional status, at predefined points in therapy, and the association with outcomes in children and adolescents undergoing treatment for cancer in institutions under asociación de hemato-oncología pediátrica de centro américa (ahopca) consortium in central america. the aim of the study is to examine the effects of the newly-established nutritional program aimed at improving the delivery of nutritional care and outcomes in children undergoing treatment for cancer in central america.

in low and middle-income countries, children with cancer are simultaneously dealing with malnutrition in high proportions. without proper access to care and a minimal or basic level of care, these children are exposed to worse conditions. studies have shown that more than half of the children with cancer are also malnourished at diagnosis. this increases children's risk of complications associated with the treatment as well as the abandonment of care, as well as decrease the level of survival rates. with an established nutritional education and clinical intervention program, the outcomes of these children can be improved, especially in central america where the cancer rates and malnutrition is high, as shown by several studies.

Eligibility criteria:
inclusion criteria: * diagnosis of childhood cancer (solid tumors, acute lymphoblastic leukemia (all), other lymphomas) * recruited at diagnosis * under the age of 18 years exclusion criteria: * other cancer diagnosis * palliative care patients

Keywords: malnutrition childhood cancer central america
virgin coconut oil (vco) as a potential adjuvant therapy in covid-19 patients

Conditions: Coronavirus Infections

Summary: virgin coconut oil (vco) contains multiple compounds which have antibacterial, antiviral, and immunomodulatory properties. the role of vco as an antivirus to treat covid-19 requires further studies. a previous study has investigated the used of 30 ml of vco to healthy volunteers for a month and reported no side effect. here the investigators conduct a pilot trial to investigate the effect of vco towards the clinical outcomes of covid-19 patients in indonesia.

the subjects of this pilot study are patients diagnosed with covid-19 in central public hospital dr. sardjito, teaching hospital of universitas gadjah mada (ugm), and yogyakarta covid-19 referral hospitals (rsud wonosari and sleman). the covid-19 patients are recruited according to the inclusion and exclusion criteria, then divided randomly into two groups. group i, the intervention group, consists of covid-19 patients receiving standard therapy and 15 ml of vco twice a day for 14 days. group ii, the control group, consists of covid-19 patients receiving standard therapy and 15 ml of placebo twice a day for 14 days. both groups are monitored for four weeks with a nasopharyngeal or oropharyngeal polymerase chain reaction (pcr) swab test.

Eligibility criteria:
inclusion criteria: * adult patients, age ≥ 18 years old. * covid-19 patients diagnosed with nasopharyngeal/oropharyngeal pcr swab specimens that are treated in central public hospital dr. sardjito, teaching hospital of universitas gadjah mada (ugm), and yogyakarta covid-19 referral hospitals. * patients with mild and moderate pneumonia symptoms that are treated in central public hospital dr. sardjito, teaching hospital of universitas gadjah mada (ugm), and yogyakarta covid-19 referral hospitals. exclusion criteria: * patients with liver function disorder. * vco hypersensitivity. * patients with severe pneumonia and/or acute respiratory distress syndrome (ards). * pregnant patients. * patients with malignant comorbidity. * critical or unconscious patients. * patients using other immunomodulators similar to vco within less than three days before vco administration.

Keywords: covid-19 treatment virgin coconut oil