Kornimate/medical-research-clean huggingface dataset:
fu's subcutaneous needling treatment for biceps tendinopathy

Conditions: Bicep Tendinitis

Summary: biceps tendinopathy is a common cause in shoulder-pain symptoms. the major mechanism is overuse of the biceps muscles. the long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles.we will conduct the randomized, open label experiment to evaluate the immediate, short-term, and long-term effect of fu's subcutaneous needling (fsn).

biceps tendinopathy is a common cause in shoulder-pain symptoms. the major mechanism is overuse of the biceps muscles. the long-term accumulated and poor repaired trauma causes myofascial trigger points in the related muscles. common symptoms are pain in the anterior shoulders and radiating pain in the biceps. pain can be further elicited with lifting, pulling and repetitive overhead activity. therefore, it can have a major impact on the patient's activity of daily life. fu's subcutaneous needling (fsn), as one of the dry needle treatments, performed by swaying a disposable fu's subcutaneous needle parallel to the underlying muscles after penetrating the skin to the subcutaneous fascia. with the reperfusion activities, myofascial pain and soft tissue pain caused by myofascial trigger points can be decreased effective simultaneously. so far, there is no solid research or clinical trial to evaluate the efficacy of the treatment yet. we will conduct the randomized, open label experiment to evaluate the immediate, short-term, and long-term effect of fsn. outcome measures include visual analog scale, shoulder pain and disability index, pressure pain threshold, muscle tone changes and ultrasonographic evaluaton of biceps peritendinous effusion.

Eligibility criteria:
inclusion criteria: 1. subjects older than 20 years of age who can cooperate with the experimental volunteers. 2. suffering from biceps tendon lesions for more than one month, and subjective pain intensity (vas) greater than 5 points. 3. there is a local tender point in front of the shoulder, and the shoulder joint pronation test can induce pain. 4. under soft tissue ultrasound, the thickness of biceps peritendinous effusion (bpe) on the affected side of the biceps tendon is greater than1 mm. exclusion criteria: 1. there are contraindications to general treatment, such as serious medical problems, recent serious trauma, or pregnant women. 2. there has been a history of drug abuse (including excess alcohol) that affects pain assessors. 3. have received shoulder, neck or upper back surgery. 4. people with central or peripheral nerve disease. 5. cognitive impairment, unable to cooperate with the experimenter. 6. patients currently receiving other treatments for biceps tendinopathy. 7. patients receiving shoulder injection treatments within the last 6 months. 8. patients with rheumatic diseases.

Keywords: fu's subcutaneous needling myofascial trigger point muscle tone
do people with insomnia sleep better after psychological treatment?

Conditions: Insomnia

Summary: the principal aim of the study is to evaluate if cbt for insomnia is associated with improvement in the psg sleep of patients treated in primary care. furthermore,the relationship between subjectively-assessed sleep and psg sleep are investigated(at pre-treatment, at post-treatment, in relation to treatment change.


Eligibility criteria:
inclusion criteria: meets clinical/rdc criteria for primary insomnia healthy adult (18+ years) exclusion criteria: evidence of sleep disorders other than insomnia use of sleeping pills major psychopathologies

Keywords: insomnia sleep psg behavioural treatment
gaba treatment in subjects with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: test if a food supplementation with gaba can improve insulin production capacity in type 1 diabetes patients by turning alfa cells into beta cells in accordance with mice and cell studies.randomised parallel study with placebo as control

our results indicate that alfa-cells can be regenerated and used to regenerate functional beta-like cells in vivo in type 1 diabetes models. aiming to eventually apply these findings to type 1 diabetic patients, we initiated multiple screens seeking for compounds inducing alfa-to-beta-cell conversion. using the mouse as a model, we thereby found that gaba (gamma-aminobutyric acid) could promote a cycle of conversion of alfa-cells into functional beta-like cells,gaba being considered as a non-harmful food supplement, one could envision a trial in type 1 diabetic patients. indeed, a putative cure for type 1 diabetes may include halting the autoimmune insult to the pancreatic beta-cells and restoring insulin secretion by expanding beta-cell mass by beta-cell-regeneration and/or preventing beta-cell apoptosis induced by cytokines. immunosuppression initiated at the onset of type 1 diabetes has been shown to preserve beta-cell function, but is associated with significant toxicities. other studies using nicotinamide and parenteral insulin have failed to prevent development of type 1 diabetes. objectives primary objective: to investigate the effect and safety of the dietary supplement gaba provided at a dose of 6 g daily compared to placebo for 12 weeks on change in beta-cell function in patients with c-peptide negative type 1 diabetes as an adjunctive therapy to insulin treatment. population a total of 30 patients with c-peptide negative type 1 diabetes, randomised 2:1 gaba: placebo. intervention after randomisation patients are treated with the dietary supplement gaba or matching placebo, titrated to 3 x 2g, or maximum tolerated dose, for 12 weeks. the insulin dose is reduced if needed according to self-monitored blood glucose (smbg) and hypoglycaemic episodes.

Eligibility criteria:
inclusion criteria:stimulated c peptide \<0.03 mmol/l type 1 diabetes - exclusion criteria: * • type 2 diabetes * fertile women not using chemical (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormonal vaginal ring or transdermal hormonal patch) or mechanical (spirals) contraceptives * pregnant or nursing women * cancer unless in complete remission for \> 5 years * treatment with oral glucocorticoids * hypoglycaemia unawareness (unability to register low blood glucose) * known or suspected hypersensitivity to trial product or related products * abuse of alcohol or drugs, or any other co-existing condition that would make patients unsuitable to participate in the study, as deemed by the investigators * receipt of an investigational drug within 30 days prior to visit 0 * simultaneous participation in any other clinical intervention trial * chronic systemic use of steroids * seizure disorder * current use of baclofen, valium, acamprosate, neurontin, or lyrica

Keywords: beta cell
dexmedetomidine as a rapid bolus in children for emergence agitation

Conditions: Tonsillectomy

Summary: to determine the efficacy of a rapid bolus injection of dexmedetomidine on the incidence of emergence agitation in anesthetized children and the cardiovascular profile of a rapid bolus injection of dexmedetomidine.


Eligibility criteria:
inclusion criteria: * children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion * asa 1,2,3 * females who have started menses but have a negative urine pregnancy test exclusion criteria: * patients with known dysrhythmias, * not recovering in the icu * developmental delay, * autism communication disorder * bleeding disorder * pi discretion

Keywords: tonsillectomy emergence agitation
efficacy of rtms (repetitive transcranial magnetic stimulation) on patients with somatoform pain disorder

Conditions: Pain

Summary: chronic somatoform pain is common in psychiatric patients. chronic somatoform pain causes significant distress and disrupts social functioning. moreover, chronic somatoform pain often does not sufficiently respond to medication. chronic somatoform pain is associated with medial pain system. the medial pain system is comprised of structures engaged in affect and motivation, such as medial thalamus and limbic structures. the medial pain system gets inhibitory control from motor cortex. functional neuroimaging studies indicate that chronic somatoform pain is associated with hypoactivity of motor cortex, defective inhibitory process, and hyperactivity of medial pain system. repetitive transcranial magnetic stimulation (rtms) is a safe and non-invasive tool to modulate neurophysiologic activity of the focal brain. therefore, pain relief by rtms can be obtained from motor cortex stimulation, restoration of defective inhibitory process, and deactivation of medial pain system. studies have shown that motor cortex stimulation using rtms can relieve pain in patients with neuropathic pain. however, to our knowledge, there is no rtms study on chronic somatoform pain in psychiatric patients. the purpose of this study is to evaluate the effect of motor cortex rtms on chronic somatoform pain.

chronic somatoform pain is common in psychiatric patients. chronic somatoform pain causes significant distress and disrupts social functioning. moreover, chronic somatoform pain often does not sufficiently respond to medication. chronic somatoform pain is associated with medial pain system. the medial pain system is comprised of structures engaged in affect and motivation, such as medial thalamus and limbic structures. the medial pain system gets inhibitory control from motor cortex. functional neuroimaging studies indicate that chronic somatoform pain is associated with hypoactivity of motor cortex, defective inhibitory process, and hyperactivity of medial pain system. repetitive transcranial magnetic stimulation (rtms) is a safe and non-invasive tool to modulate neurophysiologic activity of the focal brain. therefore, pain relief by rtms can be obtained from motor cortex stimulation, restoration of defective inhibitory process, and deactivation of medial pain system. studies have shown that motor cortex stimulation using rtms can relieve pain in patients with neuropathic pain. however, to our knowledge, there is no rtms study on chronic somatoform pain in psychiatric patients. the purpose of this study is to evaluate the effect of motor cortex rtms on chronic somatoform pain.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of somatoform pain disorder, chronic exclusion criteria: * neurological disorder * history of epilepsy

Keywords: chronic pain pain disorder
brief cognitive behavioural therapy for insomnia versus sleep hygiene for sleep difficulties in early pregnancy

Conditions: Sleep Disturbance; Perinatal Anxiety; Perinatal Depression

Summary: pregnant and postpartum individuals often have difficulty sleeping and these sleep problems can negatively impact both the parent and infant. research suggests that pregnant individuals prefer non-medication-based treatment for their sleep difficulties but there is a lack of research on the success of sleep treatment during pregnancy. currently, there are two main non-medical treatments for sleep difficulties available. the first, cognitive behavioural therapy (cbt), is the first treatment recommended for insomnia and has been found to successfully treat insomnia during pregnancy and the postpartum period. in addition, shortened sessions of cbt for insomnia have also been found to successfully reduce sleep difficulties. the second option is sleep hygiene education which is the most commonly offered treatment for sleep difficulties and has been found to improve sleep problems. the present study will compare the effectiveness of a cbt for insomnia group workshop to a sleep hygiene group workshop.


Eligibility criteria:
inclusion criteria: 1. ≥18 years 2. first, second, or third trimester of pregnancy (up to 34 weeks gestation) to allow for early/proactive benefit of sleep intervention. 3. subjective difficulties with sleep (a score of 8 or higher on the insomnia severity index) 4. fluent in english. exclusion criteria: 1. severe depression/active suicidal ideation or psychotic 2. unstable general medical condition 3. current use of sleep aids or if taking a prescriptive medication, it remains stable in dose and type for study duration 4. a sleep disorder other than insomnia (e.g., restless leg syndrome).
palmitoylethanolamide for post-operative pain prevention

Conditions: Chronic Post-operative Pain

Summary: postsurgical pain becomes chronic when it lasts more then two months after surgery. a neurogenic or neuropathic pathogenesis is hypothesized for this event that reaches high rates after urologic and gynecologic surgeries. palmitoylethanolamide (pea) binds to mast cells and regulates pro-inflammatory factors release, without adverse events. the investigators assume that perioperative administration of pea can reduce chronic postsurgical pain incidence of patients undergoing to urologic and gynecologic elective surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing elective gynecological or urological surgical procedures exclusion criteria: * age \< 18 * pregnancy or nursing * pre-existing chronic pain * severe hepatic or renal failure * post-operative progression of local cancer disease * post-operative infection or inflammation of surgical wound

Keywords: surgical pain chronic pain prevention palmitoylethanolamide
prophylactic treatment of hepatic dysplastic nodules in hbsag positive patients

Conditions: Dysplastic Nodule of Liver; Chronic Hepatitis B

Summary: the aim of this study is to determine that for hepatic dysplastic nodules in patients with chronic hepatitis b, instead of enhanced follow-up, whether early minimally-invasive ablation therapy can reduce the incidence of hepatocellular carcinoma.

hepatic dysplastic nodules (dns) include high grade dysplastic nodules (hgdns) and low grade dysplastic nodule (lgdns), their incidences are high in patients with liver cirrhosis. once diagnosed, all latest versions of the major guidelines recommend enhanced follow-up, and no treatment would be provided until the diagnosis of hepatocellular carcinoma (hcc) is established during the follow-up. while on the other hand, mounting evidence shows that dns have relatively high transition rate to progress to hcc. in 154 patients with chronic hepatitis and cirrhosis, kobayashi et al. reported the annual transition rate of 20% for patients with hgdn and 10% for patients with lgdn. the 5-year cumulative transition rate from hgdn and lgdn was 80.8% and 30.2%, respectively. even regenerative nodules (rns) without dysplasia evolved into hcc in 12.4%.more recently, sato et al. studied 68 large regenerative nodules (lrns) and 20 dns from 1,500 consecutive nodular lesions; the 50-month transition rate was 13.6% in lrns and 40% in dns. earlier studies support these findings. adenomatous polyps are accepted precursors to colorectal cancer (crc) and removed to prevent cancer. compared to the above transition rates, a recent cohort study estimated that the average annual transition rate from advanced adenoma to crc in men was 3.1%,so the 5-year-transition rate was around 15%. since the transition rate of hepatic dns is much higher than the colorectal adenomatous polyps, is "enhanced follow-up" really the best choice of the treatment? so in this proposed clinical trial, we hypothesize that for hepatic dns discovered in patients with chronic hepatitis b, early minimally-invasive ablation treatment will decrease the incidence of hcc. recruited patients will be divided in to two groups randomly, in the "observation group", patients will be followed-up and receive no therapy; while in the "ablation group", the dns will be ablated by minimally-invasive ablation therapies, including rfa, pei, mwa, etc. all patients will be followed-up according to the aasld guideline. then the incidence of hcc of the two arms will be compared.

Eligibility criteria:
inclusion criteria: * patients with chronic hbv * diagnosis of hepatic dysplastic nodule(s) be confirmed by biopsy. exclusion criteria: * concurrent hcv infection

Keywords: high grade dysplastic nodule (hgdn) low grade dysplastic nodule (lgdn)
study for patients with lung metastatic advanced gastric cancer and nsclc treated with apatinib

Conditions: Gastric Cancer Metastatic to Lung; Lung Cancer

Summary: the primary end point was progression-free survival (pfs), secondary end points included duration of locoregional control (lrc), overall survival (os), quality of life and safety. for metastatic lung cancer, lrc is the local control of metastatic lung tumor here.

between february 1, 2015 and may 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the affiliated hospital of qingdao university. histologically proven were identified retrospectively using the clinical research information systems (cris) database. all patients were with karnofsky performance status ≥70% or an eastern cooperative oncology group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions. cardiac disease and hemorrhagic disease were excluded. all patients had pre-therapy chest computed tomography (ct) prior to apatinib treatment, and follow-up chest ct at least every 4 weeks. the primary end point was progression-free survival (pfs), secondary end points included duration of locoregional control (lrc), overall survival (os), quality of life and safety. for metastatic lung cancer, lrc is the local control of metastatic lung tumor here. other patient demographic and clinical data, including age, gender; stage of disease, apatinib administered inclusion and withdrawal date, adverse events, oncologic clinical response, comorbid conditions, and smoking history, were retrieved from the cris database.

Eligibility criteria:
inclusion criteria: 1. between february 1, 2015 and may 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma 2. multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the affiliated hospital of qingdao university. 3. histologically proven were identified retrospectively using the clinical research information systems (cris) database. 4. all patients were with karnofsky performance status over 70% or an eastern cooperative oncology group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions. exclusion criteria: 1. cardiac disease and hemorrhagic disease were excluded. 2. patients with lung cavitation before apatinib treated.

Keywords: cavitation pfs
radiation-induced toxicity of the heart

Conditions: Non-small Cell Lung Cancer; Esophageal Cancer; Breast Cancer Female

Summary: late side effects in radio(chemo)therapy \[r(ch)t\] pose a critical limitation to patients' overall survival and quality of life. even though toxicities of the heart are highly relevant for patients with cancer in the thoracic region, risk stratification models for these toxicities are lacking. in this study, liquid, functional and imaging biomarkers are being investigated for their use in prediction of cardiac toxicity following r(ch)t for patients with thoracic malignancies.

79 patients with non-small cell lung or esophageal cancer, and 246 patients with breast cancer to be treated with curative r(ch)t at the university hospital carl gustav carus dresden, germany will be included in this investigation. dosimetric parameters from the applied radiation treatment plans, magnetic-resonance-imaging, electrocardiography, transthoracic echocardiography as well as blood-biomarkers will be collected to determine their predictive power against the primary endpoint of cumulative grade ≥ 2 cardio-toxicity (common terminology criteria for adverse events \[ctcae\] v 5.0) 3-5 years after r(ch)t.

Eligibility criteria:
inclusion criteria: * patients 18 years old or older * patient's consent and written consent is available * patients with the non-small cell lung cancer or esophageal cancer or breast cancer who have an indication for intended curative radio(chemo)therapy (in the case of breast cancer inclusion of female patients only) exclusion criteria: * patients who are not capable of giving consent * pregnant women * patients with contraindications for mri examinations (pacemakers, defibrillators, neurostimulators, aneurysm clips, cochlear implants, permanent make-up, metal splinters or osseosynthetic implants) * patients with insufficient kidney function (glomerular filtration rate (gfr) of less than 30 ml/min) * patients with the aforementioned tumour entities for whom a palliative indication exists

Keywords: non-small cell lung cancer esophageal cancer breast cancer cardiotoxicity radio(chemo)therapy mri cardiac function test omics analyses
hope-b: trial of amt-061 in severe or moderately severe hemophilia b patients

Conditions: Hemophilia B

Summary: this is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of amt-061 and to further describe its safety profile. the study drug is identified as aav5-hfixco-padua (amt- 061). amt-061 is a recombinant adeno-associated viral vector of serotype 5 (aav5) containing the padua variant of a codon-optimized human fix complementary deoxyribonucleic acid (cdna) under the control of a liver-specific promoter. the pharmaceutical form of amt-061 is a solution for intravenous infusion administered at a dose of 2 x 10\^13 gc/kg.


Eligibility criteria:
inclusion criteria: 1. male 2. age ≥18 years 3. subjects with congenital hemophilia b, classified as severe or moderately severe, and are currently on factor ix prophylaxis 4. \>150 previous exposure days of treatment with factor ix protein exclusion criteria: 1. history of factor ix inhibitors 2. positive factor ix inhibitor test at screening 3. select screening laboratory value \>2 times upper limit of normal 4. positive human immunodeficiency virus (hiv) test at screening, not controlled with anti-viral therapy 5. active infection with hepatitis b or c virus at screening 6. history of hepatitis b or c exposure, currently controlled by antiviral therapy at the end of the lead-in phase 7. previous gene therapy treatment 8. receipt of an experimental agent within 60 days prior to screening 9. current participation or anticipated participation within one year after study drug administration in this trial in any other interventional clinical trial involving drugs or devices

Keywords: gene therapy fix factor ix bleeding viral vector padua hemophilia aav (adeno-associated virus) serotype 5 aav (adeno-associated virus) serotype 5