Kornimate/medical-research-clean huggingface dataset:
the effect of dan-shen extract on lipoprotein associated phospholipase a2 levels in patients with stable angina pectoris

Conditions: Angina, Stable; Inflammation

Summary: this is a randomized, double-blind, placebo-controlled, adaptive clinical trial, which will assess the effect of danshenduofensuanyan\[danshen (a kind of chinese herbal drug) extract\] treatment on lipoprotein associated phospholipase a2 level in patients with stable angina pectoris.


Eligibility criteria:
inclusion criteria: 1. age:18 years-75 years; 2. written informed consent; 3. patients with a clinical diagnosis of chronic stable angina, which fulfil one of the following conditions: 1. symptoms that support the diagnosis of chronic angina and/or a history of an abnormal exercise response limited by angina and/or electrocardiograph (ecg) changes 2. a history of myocardial infarction and st-t changes, 3. stenosis of more than 50 % in at least one major epicardial coronary artery, as shown by coronary angiography or computed tomography angiography, 4. coronary heart disease confirmed by radionuclide angiocardiography; 4. patients with moderate angina pectoris, which is defined as grade ii or iii on the canadian cardiovascular society angina grading scale. exclusion criteria: 1. patients with severe complications that would complicate the condition, as assessed by the investigator, including liver or renal dysfunction, severe cardiopulmonary dysfunction, pulmonary hypertension, chronic obstructive pulmonary disease, a history of epilepsy or cerebral haemorrhage. 2. patients who were angina-free during the run-in period without taking any drug. 3. patients who experienced myocardial infarction or who were classified as grade iv on the canadian cardiovascular society angina grading scale within the preceding 3 months. 4. patients with chest pain that is caused by any other disease (e.g., acute myocardial infarction, severe neurosis, menopausal syndrome or hyperthyroidism). 5. patients with a history of drug-induced bleeding or a history of bleeding caused by warfarin. 6. patients with a history of haematopoietic disorder. 7. patients who have had surgery within the previous 4 weeks or who have a haemorrhagic tendency. 8. women who are pregnant or lactating or who have a positive pregnancy test, or women who have a menstrual period at baseline. 9. patients who are participating in other trials or who have participated in other trials within the past 3 months. 10. patients with a history of allergy or with a known or suspected allergy to the study drug. 11. patients with a known or suspected history of alcohol or drug abuse within the past 2 years. 12. patients with a mental disorder. 13. family members or relatives of the study centre staff. 14. inability to adhere to study procedures

Keywords: danshenduofensuanyan lp-pla2 coronary artery disease salvia miltiorrhiza
an extension study of teduglutide in japanese participants with short bowel syndrome who completed 24 weeks of treatment in shp633-306 or ted-c14-004

Conditions: Short Bowel Syndrome

Summary: the purpose of this clinical study is to evaluate the long-term safety and efficacy of teduglutide in japanese participants with pn/iv (parenteral nutrition/intravenous)-dependent sbs (short bowel syndrome) who completed shp633-306 or who were in the extension phase of the ted-c14-004 (nct02340819) study.


Eligibility criteria:
inclusion criteria: participants who meet all of the following criteria will be enrolled in this study: 1. ability to voluntarily provide written, signed, and informed consent to participate in the study. 2. completion of the shp633-306 study or participation in ted-c14-004 (nct02340819) stage 3 or stage 4. 3. females of childbearing potential must agree to comply with the contraceptive requirements of the protocol. 4. an understanding, ability, and willingness to fully comply with study procedures and restrictions. exclusion criteria: there are no exclusion criteria for this study.
study of dysarthria, swallowing disorders and respiratory in parkinson's disease

Conditions: Parkinson's Disease

Summary: the investigators prospectively enrolled 64 early pd patients (less than 3 years after the first symptom) in order to prospectively assess the natural history of non-dopaminergic symptoms.

patients were evaluated at baseline and after 2 years in off drug condition. clinical, psychological, neuropsychological evaluations, functional respiratory evaluation, swallowing video fluoroscopy, dysarthria, gait and axial disorders.

Eligibility criteria:
inclusion criteria: * idiopathic parkinson's disease exclusion criteria: * dementia * severe axial gait disorders * respiratory or ent pathology * pregnancy

Keywords: idiopathic early parkinson's disease
amplitude-integrated eeg in improvement of seizure detection and prognostication in children with tbi

Conditions: Traumatic Brain Injury

Summary: the goal of this study is to determine whether the addition of aeeg to ceeg in clinical practice does in fact help picu physicians detect subclinical seizures in this population.

children with moderate to severe tbi are at risk of significant long-term neurological sequelae. careful post-injury management is crucial in optimizing their recovery. seizures are a frequent complication. they are associated with worse outcome and require prompt intervention. however, they are often subclinical and are only detectable by gold-standard conventional electroencephalography (ceeg); a costly, complex monitoring device that is not readily available 24/7 in many pediatric intensive care units (picus) and can only be interpreted by neurologists. on average, picus obtain only 1-2 ceeg reports per day from neurologists and this can lead to significant delays in seizure identification and treatment. amplitude-integrated eeg (aeeg) is a compressed form of real-time ceeg monitoring that can be added to ceeg monitoring. it is more easy to interpret and can be taught to picu providers with limited training. it is a promising complementary tool that could help picu physicians identify subclinical seizures and treat seizures more promptly. this could significantly improve the global outcome of this vulnerable population.

Eligibility criteria:
inclusion criteria: * moderate to severe tbi defined by a post-resuscitation glasgow coma scale (gcs) of 3-8 (severe) or 9-12 (moderate), this includes those with accidental tbi, abusive head trauma, and cases of polytrauma * decision by the primary medical team to initiate ceeg monitoring exclusion criteria: * patients for whom it is impossible to record ceeg for any reason will be excluded from the study * premature neonates * brain death or suspected brain death at picu entry * unavailable equipment for cegg and/or aeeg * consent to participate denied by parents and/or patient

Keywords: aeeg, ceeg
a research study looking into the effect of semaglutide and nnc0480 0389 on blood levels of a birth control pill in woman after menopause

Conditions: Diabetes Mellitus, Type 2

Summary: novo nordisk is developing a combination therapy with the investigational drug nnc0480-0389 and an already approved medicine called "semaglutide" for the treatment of type-2 diabetes (t2d). it is expected that the combination will further improve the blood sugar control compared to semaglutide therapy alone. the study will investigate the influence of the combination of semaglutide and nnc0480-0389 on the blood levels of a birth control pill (a combined oral contraceptive consisting of ethinylestradiol and levonorgestrel) and paracetamol. participants will get semaglutide and nnc0480-0389 as injection under the skin of their belly using a pen-injector. the injections will be given once weekly for 14 weeks. additionally, participants will at two occasions get paracetamol as soluble tablet in connection with a standardised breakfast meal. further, participants will get the birth control pill in form of tablets in two periods of 8 days each. participants will get the combination of semaglutide and nnc0480-0389 as well as paracetamol and the combined contraceptive in any case. the study participation will last up to about 24 weeks. participants will have 25 visits at the study centre. for 4 of the visits participants will stay at the study centre; the remaining visits will be outpatient. only healthy postmenopausal women can take part in this study.


Eligibility criteria:
inclusion criteria: * postmenopausal female, aged greater than or equal to 45 years at the time of signing informed consent * body mass index between 20.0 and 29.9 kilogram per meter square (kg/m\^2) (both inclusive) * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator exclusion criteria: * any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol * hba1c greater than or equal to 6.5 % (48 millimoles per mole (mmol/mol)) at screening * use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cytochrome p450 enzyme (cyp) pathways, such as hypericum (st. john's wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. exceptions are routine vitamins, occasional use of paracetamol, ibuprofen and acetylsalicylic acid, or topical medication not reaching systemic circulation * use of hormone replacement therapy within 4 weeks before first dose of trial product or intention to initiate treatment with hormone replacement therapy during the study * presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions
inspiratory muscle training in mechanically ventilated patients in intensive care unit

Conditions: Intensive Care Patients Invasively Ventilated; Mechanical Ventilation; Inspiratory Muscle Training; Diaphragm Ultrasonography

Summary: in addition to conventional chest physiotherapy, inspiratory muscle training will be applied in mechanically ventilated intensive care patients. it is aimed to examine the effects of inspiratory muscle training on respiratory muscle strength, diaphragm thickness, and diaphragm excursion in intubated or tracheostomized patients with mechanical ventilation in the intensive care unit.

subjects who mechanically ventilated in the intensive care unit will be divided two groups. study group will recieve inspiratory muscle training in addition to convantional chest physiotherapy. control group will recieve convantional chest physiotherapy. training will continue until discharge or until the 21st day of the training. respiratory muscle strength, diaphragm thickness and diaphragm excursion were measured before training and before discharge.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * hemodynamic stability and alert * able to spontaneously trigger the ventilator and perform at least one command for activation of respiratory muscles * required mechanical ventilation support with continuous spontaneous ventilation mode or pressure- or volume-controlled intermittent mandatory ventilation (6 breaths/min) mode * required pressure support ≤ 15 cmh2o and peep ≤ 10 cmh2o * unable to breathe without support for 72 consecutive hours following the resolution of factors leading to respiratory failure * fio2 of 0.5 or less * pao2 greater than 60 mmhg and capable of sufficient gas exchange exclusion criteria: * cooperation disorder * trauma or deformity related to the thorax that affect respiration * progressive neuromuscular disease * excessive bronchial secretion (requiring more than one suctioning per hour) * need for continued sedative or analgesic agents * use of home-type mechanical ventilation before admission to the hospital * cardiac, pulmonary, or other conditions leading to impaired stability * impaired cooperation, compliance, and motivation

Keywords: physiotherapy and rehabilitation inspiratory muscle training ultrasound of diaphragm intensive care unit mechanical ventilation
an extension study of an investigational drug in patients with hypercholesterolemia (0653a-038)(completed)

Conditions: Hypercholesterolemia

Summary: the purpose of this study is to evaluate the lipid lowering effects of an investigational drug in patients with hypercholesterolemia (high cholesterol).


Eligibility criteria:
inclusion criteria: * high cholesterol exclusion criteria: * patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study.

Keywords: primary hypercholesterolemia
early-phase schizophrenia: practice-based research to improve outcomes

Conditions: First Episode Psychosis

Summary: the goal if the project is to develop a learning health network devoted to the treatment of first episode psychosis.

the raise etp study, designed and conducted by our group, signaled that a coordinated specialty care (csc) model could be feasibly delivered in community mental health clinics in multiple states and was effective. since then, with the support of samsha block grants to states, there are csc programs across the nation. the goal of this project is to develop a learning health system with sites providing csc treatment of first-episode psychosis (fep). sites are drawn from five states: connecticut, florida, michigan, oklahoma and south carolina. they vary in populations served, levels of funding available and research experience. all are committed to advancing the development of csc using a health learning system model, to implementing a practical assessment strategy to enhance outcome assessment and to conducting research to improve outcomes that will be meaningful to the full range of stakeholders.

Eligibility criteria:
inclusion criteria: * enrolled in csc program exclusion criteria: * none
open appendectomy versus laparoscopic appendectomy

Conditions: Appendicitis

Summary: 1. laparoscopic appendectomy may not be a superior procedure when compared with open appendectomy; 2. various modifications in laparoscopic appendectomy procedure may reduce the technical diffuculty and overall costs.

the study will be a prospective randomized clinical trial. totally 150 patients who are diagnosed to have acute appendicitis will be randomly divided into 3 equal groups (n=50 for each group). first group will have traditional open appendectomy procedure; second group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by metal endoclips; and third group will have laparoscopic appendectomy procedure in which appendiceal stump is secured by intracorporeal suture ligation. the preoperative parameters that will be obtained for all patients are: detailed information for communication, patient history, age, gender, the presence of spesific symptoms (nausea, vomiting, loss of appetite, right lower quadrant pain), the presence of clinical signs, laboratory findings, and radiological findings. the peroperative parameters that will be recorded are: operative time, the type and the length of incisions, the number of trocars, operative findings, details of laparoscopic technique, generic name of prophylactic antibiotic, and the presence of additional findings. all of the patients will undergo a clinical evaluation by attending surgeon on the 5th, the 15th, and the 30th postoperative day. the postoperative clinical evaluation will include the examination of the patient for surgical site infection and other wound complications, and the performance of a spesific quality-of-life index questionnaire. in the end of the study, all parameters and quality-of-life scores will undergo statistical analysis.

Eligibility criteria:
inclusion criteria: * the patients with a preoperative diagnosis of acute appendicitis exclusion criteria: * the patients who are not volunteered to join the study * the patients who are diagnosed to have peroperative or histopathological pathology other than acute appendicitis * the patients who have additional pathologies accompanying acute appendicitis

Keywords: appendicitis open appendectomy laparoscopic appendectomy endoclip intracorporeal suture quality-of-life
double- versus single-balloon enteroscopy for obscure small-bowel bleeding

Conditions: Small-Bowel Disorders

Summary: double-balloon enteroscopy (dbe) is now an established method for diagnostic and therapeutic small-bowel endoscopy. single-balloon enteroscopy (sbe) has been introduced to simplify the technique. a prospective randomized study was carried out to compare the two methods in obscure small bowel bleeding

th e double-balloon enteroscopy (dbe) system, developed by dr yamamoto, was presented for the fi rst time in japan in 2001. the system has become established throughout the world for diagnostic and therapeutic small-bowel examinations, and it is now used universally in routine clinical work. another balloon enteroscopy system was recently introduced in which only one balloon is attached at the tip of the overtube; the method is therefore known as sbe. sbe is a simplification of the double balloon method, and its value has already been confirmed for difficult colonoscopies. the question of whether similar results can be achieved with the single balloon method in the more complex situation of the small bowel has not yet been answered.

Eligibility criteria:
inclusion criteria: 1. suspected or known small-bowel bleeding 2. age: 16-70 exclusion criteria: 1. pregnancy 2. coagulation disorders 3. prior surgery of the small bowel and colon

Keywords: small-bowel disorders double-balloon enteroscopy single-balloon enteroscopy
acute sympotomatic seizure secondary to autoimmune encephalitis and autoimmune-associated epilepsy

Conditions: Autoimmune Encephalitis; Epilepsy; Seizures

Summary: previously, scholars called the seizures secondary to autoimmune encephalitis（ae） "autoimmune related epilepsy", but the seizures secondary to ae are usually controlled after the improvement of encephalitis, which does not meet the "persistent" characteristics of epilepsy. only a subset of patients with seizures lasting several years require long-term antiseizure medications (asm). in 2020, the international coalition against epilepsy classified it as "acute symptomatic seizure secondary to ae". assae) and autoimmune-associated epilepsy (aae) . the former is caused by ae, which has clinical manifestations of ae at the same time as epileptic seizures at the beginning or recurrence. the proportion and type of epileptic seizures are different due to different causes, and epileptic seizures are also controlled after the disease is controlled. the latter is that after adequate immunotherapy, there are still persistent seizures, and there is no obvious evidence of inflammatory activity, this type of patient application asm and immunotherapy is not effective. secondly, with the deepening of ae research, gradually found that some aae can still be asms cure, such as carbamazepine, ocasepine, lakaosamine. on the one hand, it works by influencing cellular and humoral immune responses. on the other hand, effectiveness of sodium channel blockers in focal epilepsy. lacosamide is a slow sodium channel blocker that belongs to the third generation of asm. it has a short half-life and can be quickly increased to an effective dose with a low incidence of adverse reactions. therefore, the investigators chose to add oral antiepileptic therapy with lacosamide in aae populations to observe efficacy and safety.


Eligibility criteria:
inclusion criteria: 1. confirmed autoimmune encephalitis (2016,lancet); 2. meet the classification criteria for epilepsy (2017,international league against epilepsy); 3. patients who still have seizures after taking asm after the control of ae disease were included in the third part of the study; 4. all patients volunteered and signed an informed consent form; exclusion criteria: 1. incomplete key clinical data; 2. people with epilepsy or other intracranial diseases before diagnosis; 3. there is no epileptic author during the onset of autoimmune encephalitis;
diagnosis of adenoid cystic carcinoma on 68ga-psma-617 pet-ct and therapy with 177lu-eb-psma-617

Conditions: Adenoid Cystic Carcinoma

Summary: adenoid cystic carcinoma (acc) accounts for 24% of salivary gland malignant tumors, is characterized by frequent local recurrences and distant metastasis, mainly to lungs. considering its origination from salivary glands, an organ with intense physiological uptake of 68ga-psma-617, this study aims to evaluate 68ga-psma-617 uptake in local recurrent or metastatic acc in comparison with 18f-fdg uptake in the same patients, and assess the feasibility of 177lu-eb-psma-617 treatment in patients with the advanced acc.

adenoid cystic carcinoma (acc) is a rare tumor entity with a yearly incidence of 3-5 cases per million. acc arises in the major salivary glands and more often in the minor salivary glands of the oropharynx, lip, nasopharynx, oral cavity, nasal cavity, paranasal sinus, larynx and tracheobronchial tree. acc is characterized by frequent local recurrences and distant metastasis, mainly to lungs. 18f-fdg pet/ct is considered to be a viable tool to assess acc at initial presentation. however, fdg uptake in acc is lower than in squamous cell carcinoma (scc) and not all acc lesions show detectable fdg uptake. so, it is necessary to find another effective way to detect acc and its metastases. as in known, psma is highly expressed in salivary glands, and wim van boxtel et al had demonstrated high psma-ligand uptake in a patient with recurrent and metastatic acc using 68ga-psma pet/ct. 68ga-psma has been developed as a targeting imaging agent widely used in prostate cancer in prostate cancer. thus, this prospective study is going to investigate whether 68ga-psma pet/ct may be superior for diagnosis, therapy response assessment and follow-up of acc than 18f-fdg pet/ct. furthermore, peptide receptor radionuclide therapy has been widely used in the treatment of prostate cancer lesions that showed high psma uptake on 68ga-psma pet/ct, we'll try to assess the safety and therapeutic response to 177lu-eb-psma-617 in patients with acc.

Eligibility criteria:
inclusion criteria: * confirmed treated or untreated adenoid cystic carcinoma patients; * 18f-fdg pet/ct within two weeks; * signed written consent. exclusion criteria: * pregnancy; * breastfeeding; * known allergy against psma * any medical condition that in the opinion of the investigator may significantly interfere with study compliance
modified orbital decompression in the treatment of moderate-to-severe grave's ophthalmopathy

Conditions: Graves Ophthalmopathy; Surgery

Summary: to investigate the efficacy and safety of modified deep lateral wall decompression and/or medial wall decompression for moderate-to-severe grave's ophthalmopathy.

the purpose of the study is to evaluate the effectiveness and complications of modified deep lateral wall decompression and medial wall decompression, in order to develop a standardized technical approach to the treatment of moderate-to-severe grave's ophthalmopathy.

Eligibility criteria:
inclusion criteria: 1. eugogo/nospecs grade was moderate-to-severe thyroid associate ophthalmopathy; 2. cas≤3 score; 3. stable thyroid function for at least 6 months; 4. able and willing to participate in clinical trials and ensure regular follow-up; exclusion criteria: 1. any uncontrollable clinical problems (severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant tumors); 2. b-ultrasound or ct, mri found other diseases causing exophthalmos (intraorbital space occupying lesion, inflammatory pseudotumor, neurofibroma, etc.); 3. uveitis, glaucoma, high myopia, diabetic retinopathy and other eye diseases 4. those who were considered by the researchers to be excluded