Kornimate/medical-research-clean huggingface dataset:
study of buprenorphine sublingual spray for the treatment of moderate to severe pain

Conditions: Pain

Summary: the primary objective of this trial is to evaluate analgesic efficacy of buprenorphine sublingual (under the tongue) spray compared with placebo in participants with postoperative pain after bunionectomy.


Eligibility criteria:
inclusion criteria: * meets protocol-specified criteria for qualification and contraception * willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related food, drink and medications * voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures exclusion criteria: * history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters * signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff; 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding); 3. the analysis of results

Keywords: post-surgical pain bunionectomy
nasogastric decompression following pancreaticoduodenectomy

Conditions: Pancreatic Head Neoplasm; Delayed Gastric Emptying; Post Operative Ileus; Whipple Procedure

Summary: pancreaticoduodenectomy (pd) remains the gold-standard operation for peri-ampullary neoplasms. traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. recently, the implementation of eras protocol recommended against routine use of nasogastric tube following pd. however, limited data exists surrounding the identification of those patients needing ngt decompression in the immediate postoperative period. therefore, we initiated a large prospective randomized controlled trial to evaluate the clinical outcomes of patients who retained the ngt post-pd versus those who had it removed at the end of the procedure. this study aims to assess the effectiveness of nasogastric decompression in pd recovery, with the primary endo point being the need for and impact of ngt in the postoperative recovery. the secondary endpoint will examined the re-insertion rate of ngt and identify factors that necessitate its use in the immediate postoperative period.


Eligibility criteria:
inclusion criteria: * all patients 18 years of age or older * patients undergoing successful pancreaticoduodenectomy for benign or malignant neoplasm. exclusion criteria: * patients who does not complete the procedure due to locally advanced or metastatic disease discovered during the procedure. * patient who requires prolong postoperative intubation in the postoperative period.
work design interventions for heat resilience

Conditions: Hyperthermia; Fatigue; Heat; Work-Related Condition

Summary: the goal of this project is to compare different ways to schedule a workday to see if older workers should follow a specific work protocol to reduce strain on the heart and muscles. participants will come to the lab a total of six times. during four of the visits participants will complete a box lifting task, simulating loading and unloading a delivery truck. this will take place in a hot and humid room to simulate being outdoors during the summer.


Eligibility criteria:
inclusion criteria: * 40-65 years old exclusion criteria: * musculoskeletal injury that would impact the ability to safely perform the trial * cardiovascular, metabolic, respiratory, renal, or neurologic conditions that would impact the ability to safely perform the trial

Keywords: hyperthermia worker fatigue
concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma: randomized control clinical trial

Conditions: Local Advanced High Risk Nasopharyngeal Carcinoma

Summary: this is an randomized controlled, multicenter clinical trial. the purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * newly histologic diagnosis of nasopharyngeal carcinoma(who ii/iii) * clinical stage iii\~ivb(uicc 7th) * meet at least one factor below :1 primary tumor suvmax\>10 in 18f-fdg pet/ct;2 primary tumor volume\>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter\>4cm; 4 t4n2m0; 5 t1-4n3m0;6 ebv-dna\>2×10e4 copy/l * range from 18～70 years old * wbc count ≥ 4×109/l，hemoglobin ≥ 100g/l， platelet count ≥ 100×109/l * alt or ast \< 2.5×uln、bilirubin \< 1.5×uln * oserum creatinine \< 1.5×uln exclusion criteria: * central nervous system metastases * suitable for local treatment * uncontrolled seizure disorder or other serious neurologic disease * clinically significant cardiac or respiratory disease * drug or alcohol addition * do not have full capacity for civil acts * severe complication, active infection * concurrent immunotherapy or hormone therapy for other diseases * pregnancy or lactation

Keywords: local advanced high risk nasopharyngeal carcinoma
study on the performance of symmcora® mid-term suture versus novosyn® suture in patients undergoing robotic assisted gastric bypass surgery

Conditions: Adiposity

Summary: the study is designed as a prospective, mono-centric, randomized, patient blinded comparison of unidirectional barbed suture (symmcora® mid term, ubs) vs. a conventional suture (novosyn®, cs). patient will be randomly allocated in a 1:1 ratio to either the ubs group or the cs group to perform the gastro-jejunal anastomosis (gja) and the jejuno-jejunal anastomosis (jja). the product under investigation and the conventional suture material will be used in routine clinical practice and according to the instructions for use (ifu).


Eligibility criteria:
inclusion criteria: * patients undergoing an elective, primary robotic, assisted gastric bypass surgery (with a bmi ≥40 kg/m2 or with a bmi ≥35 kg/m2) with one or more of the following comorbidities: refractory arterial hypertension, type 2 diabetes mellitus and/or proven sleep apnea) with the need to close the gastro-jejunal anastomosis (gja) and jejuno-jejunal anastomosis (jja). * age ≥18 years * written informed consent exclusion criteria: * emergency surgery * previous gastric surgery * history of chronic steroid use * pregnancy or breastfeeding * patients with hypersensitivity or allergy to the suture material * non compliance * participation in another randomized controlled trial

Keywords: gastro-jejunal anastomosis jejuno-jejunal anastomosis robotic assisted gastric bypass surgery
ripretinib combined with surgery in advanced gist that have failed imatinib therapy: a multicenter,observational study

Conditions: Gastrointestinal Stromal Tumor(GIST)

Summary: the objective of this observational study is to explore the efficacy and safety of ripretinib treatment combined with surgery in advanced gastrointestinal stromal tumors(gist) after failure of imatinib therapy.

this study is a single-arm, multicenter, observational study. a total of approximately 30 subjects were be enrolled. the patient was orally administered with ripretinib150 mg qd. 4 weeks for one cycle. efficacy was assessed every two cycles. for subjects with pr or sd after ripretinib treatment, resection of gastrointestinal stromal tumor was performed after discussion by mdt and ensure r0 resection as much as possible.ripretinib 150mg qd was continued 2 weeks after surgery. thereafter, subjectss entered the follow-up period for at least 1 year. safety and survival information will be collected

Eligibility criteria:
inclusion criteria: 1. patients voluntarily, and signed a written informed consent, good compliance with follow-up; 2. 18 years ≤ age \< 75 years, male or female; 3. histopathological examination confirmed the diagnosis of recurrent and/or metastatic advanced unresectable gastrointestinal stromal tumor; 4. according to the modified recistv1.1-gist-specific criteria, the subject has at least one measurable lesion; 5. subjects must have progressed on imatinib or have documented intolerance to imatinib. 6. ecog ps of ≤ 2, asa score ≤ 3 at screening; 7. no other malignant tumors occurred within five years; exclusion criteria: 1. molecular pathology report pdgfra exon 18 mutation(including d842v); 2. patients with other serious complications who cannot tolerate surgery: such as severe cardiopulmonary disease, heart function below clinical class 2, pulmonary infection, moderate to severe copd, chronic bronchitis, severe diabetes and/or renal insufficiency, severe hepatitis and/or child-pugh class c or b whose symptoms are significantly difficult to correct, severe malnutrition, etc; 3. pregnant or lactating women; 4. treatment with any other line of therapy in addition to imatinib for advanced gist. imatinib-containing combination therapy in the first-line treatment should not be enrolled. 5. subject has known active central nervous system metastases. 6. occurrence of bleeding, perforation, obstruction and other disease-related complications, requiring emergency surgery; 7. the patient has participated in or is participating in other clinical studies , or is taking other tki agents;
crossover trial of ad036 in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of ad036 versus placebo or atomoxetine in patients with obstructive sleep apnea.

the study is designed to examine the efficacy and safety of ad036 to treat obstructive sleep apnea. the study is a three-period single-dose randomized crossover design in which patients will undergo overnight home sleep apnea testing (hsat) with dosing of one of the following 3 treatments: ad036, atomoxetine, or placebo. participants will return 1 week after their final crossover hsat for an end of study (eos) visit.

Eligibility criteria:
inclusion criteria: * male or female, between 25 to 65 years of age, inclusive, at the screening visit. * ahi 10 to \<20, or ahi ≥20 if meets psg criteria exclusion criteria: * history of narcolepsy. * clinically significant craniofacial malformation. * clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. a medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication * cpap should not be used for at least 2 weeks prior to first study psg * history of using oral or nasal devices for the treatment of osa may enroll as long as the devices are not used during participation in the study.
sonography and haemophilia

Conditions: Sonography; Haemophilia

Summary: the aim of this study is to evaluate the possibility of establishing a patient-based ultrasound monitoring of the knee (representing a target joint accessible with any hand) with a handheld device: the following questions will be answered: 1. what is necessary for the organisational implementation of a patient-based ultrasound monitoring in patients with haemophilia? 2. is it possible to train patients with haemophilia to perform sonography of their target joints? 3. does a patient-based ultrasound monitoring with a handheld device work in a home setting? 4. what is the quality of the patient's self-acquired ultrasound images? 5. will the test persons be able to distinguish normal findings from (any) pathologic findings?


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years of age) suffering from severe haemophilia a or b * no professional medical background * submitted written consent to participate in the study and to use their study related pseudonymized data exclusion criteria: * patients suffering from other bleeding diseases * participants \< 18 years of age * participants without written consent * professional medical background
a multicenter, open-label extension study to assess the long-term safety and efficacy of an oral calcimimetic agent amg 073 (cinacalcet) in primary hyperparathyroidism

Conditions: Hyperparathyroidism, Primary

Summary: this multicenter, open-label, single-arm, extension study was designed to evaluate long-term tolerability, safety, and efficacy of cinacalcet. subjects were enrolled immediately after they completed the parent study, 990120. all subjects began treatment with 30 mg cinacalcet twice daily (bid), with dose adjustments made per protocol-specified guidelines. the study consisted of 2 consecutive phases that occurred in the following order: a dose-titration phase lasting 12 weeks and a maintenance phase lasting approximately 4½ years.


Eligibility criteria:
inclusion criteria: * successfully completed the parent study 990120 * agreed to use highly effective (in the opinion of the principal investigator) contraceptive measures throughout the study * were able to comprehend and were willing to give written informed consent for participation in the study exclusion criteria: * pregnant or breast-feeding * had a psychiatric disorder that interfered with the understanding and giving of informed consent or compliance with protocol requirements * had any other condition that reduced the chance of obtaining data (eg, known poor compliance) * participating in another investigational study at the time of study entry * had any unstable medical condition, defined as having been hospitalized within 28 days before day 1, or otherwise unstable in the judgment of the investigator

Keywords: hyperparathyroidism, primary cinacalcet
bismuth quadruple therapy in helicobacter pylori rescue therapy of different tetracycline doses and frequencies.

Conditions: Helicobacter Pylori Infection

Summary: the researchers collect h.pylori-positive patients who need rescue therapy from the outpatient clinic. the subjects were randomized to receive a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. 6-8 weeks after treatment, the subjects will re-take the 13c-urea breath test. calculate the eradication rates, adverse reaction rates and patient compliance of each group.

the researchers collect h.pylori-positive patients who need rescue therapy from the outpatient clinic. if the subject meets the selection criteria but not the exclusion criteria, and signs an informed consent form, the researchers randomized the subjects in groups: subjects received a dose and frequency of tetracycline 500mg tid or qid of bismuth quadruple eradication therapy. the medication of groups are as follows. 6-8 weeks after the eradication treatment, the subjects will review the 13c-urea breath test, and the researcher records the results. after all subjects were tested, the eradication rates, adverse reaction rates and patient compliance of each group were calculated. according to the dose and frequency of tetracycline, it is randomized into a tid treatment group and a qid treatment group. the two groups of bismuth quadruple regimens are the same, as follows: tid group: amoxicillin 1000mg bid+ tetracycline 500mg tid+ bismuth + esomeprazole 40mg bid qid group: amoxicillin 1000mg bid+ tetracycline 500mg qid+ bismuth + esomeprazole 40mg bid

Eligibility criteria:
inclusion criteria: 1. patients aged 18-70. 2. patients with h.pylori infection (positive for rapid urease test or 13c/14c-urea breath test). 3. patients who have previous failed h. pylori eradication treatment, and ≤ 2 times. exclusion criteria: 1. patients with serious underlying diseases, such as liver insufficiency (aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (cr≥2.0mg/dl or glomerular filtration rate \<50 ml/min), immunosuppression, malignant tumors, coronary heart disease or coronary artery stenosis ≥75%. 2. patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial. 3. patients with active gastrointestinal bleeding. 4. patients with a history of upper gastrointestinal surgery. 5. patients allergic to treatment drugs. 6. patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks 7. patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse 8. patients who are unwilling or incapable to provide informed consents
acute hemodynamic changes during paracentesis

Conditions: Tense Ascites; Liver Cirrhosis

Summary: the aim of our study was to evaluate hemodynamic changes during routine paracentesis in tense ascites using non-invasive inert gas rebreathing.


Eligibility criteria:
inclusion criteria: * refractory tense ascites with indication for therapeutic paracentesis exclusion criteria: * pregnancy * inability to give inform consent * inability to perform rebreathing maneuver
neuroregulatory effect and mechanism of tdcs on medial prefrontal cortex in asd

Conditions: ASD

Summary: in this proposed study, a transcranial direct current stimulator is used to intervene in the medial prefrontal cortex of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of autism spectrum disorders' intervention is discussed.

this is a randomized controlled double-blind trial. using a transcranial direct current stimulator to stimulate the autism spectrum disorders of children with autism, place an anode patch on fz and a cathode patch on right cheek to observe whether it can improve social and cognitive function in autism. parameter settings: the current size is 1.5ma. treat twice a day for 20 minutes, for a total of 7 days.

Eligibility criteria:
inclusion criteria: 1. age 4-18 years old; 2. clinically diagnosed by a psychiatrist with autism spectrum disorder; 3. confirmed by researchers (pediatric psychiatrists) that they meet the diagnostic criteria for autism spectrum disorders in the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) of the united states; 4. evaluated by researchers (pediatric psychiatrists) using the autism diagnostic interview revised (adi-r) and autism diagnostic observation schedule (ados), it is consistent with the diagnosis of autism spectrum disorders; 5. capable of cooperating with magnetic resonance spectroscopy and transcranial direct current stimulation. exclusion criteria: * a) existence of serious physical diseases and conditions, such as significant intracranial lesions, thyroid diseases, epilepsy, congenital heart disease, severe hematological diseases, systemic lupus erythematosus, visual and auditory impairments, etc; b) imaging examination showed significant brain structural abnormalities; c) having serious neurological diseases, a clear family history, or potential risks; d) metal or pacemaker implantation in the body, holes or cracks in the skull; e) taking benzodiazepines or anticonvulsants; f) the existence of clear or suspicious genetic diseases; g) conforming to the diagnosis of other serious mental illnesses, such as schizophrenia and bipolar disorder.
analysis of trunk and center of mass control development during gait in children with cerebral palsy (vertebral)

Conditions: Children With Cerebral Palsy

Summary: during the acquisition of posturokinetic abilities such as walking, postural control of the trunk is of paramount importance. indeed, its development is strongly linked to the overall motor function of children. in cerebral palsy (cp), a term that refers to a set of motor disorders following a perinatal lesion, deficits in axial control are present from early childhood. these deficits are strongly correlated with the functional deficits observed in this population. in particular, during walking, deviations of the trunk (amplitudes, accelerations) are observed in the three planes of space. while recent literature increasingly questions the impact of trunk control deficit on the walking of children with cp, elements are still missing for a holistic understanding of the interaction between locomotor and postural disorders in children with cp. in particular, no study has focused on the deviations of trunk control and the center of mass (which is a global indicator of balance strategies) during the development and maturation of walking in children with cp. therefore, the primary objective of this cross-sectional observational study will be to characterize the development of trunk control and center of mass during walking in children with cp.


Eligibility criteria:
inclusion criteria: * children (\< 18 years) with cerebral palsy * gmfcs i to iii * independent walking with or without technical walking aids (walker, crutches, etc.) * able to understand the instructions of various clinical assessments and functional explorations * affiliated with a social security scheme exclusion criteria: children with cerebral palsy * neuro-orthopaedic surgery of the lower limbs or trunk within the last 12 months * botulinum toxin a injections within the last 6 months * therapeutic intervention targeting trunk control last 6 months typically developing children * surgery on lower limbs or trunk last 12 months * neurological and/or orthopedic pathology that may influence gait