Kornimate/medical-research-clean huggingface dataset:
clinical trial of metal-reinforced teeth designed for endoscopic clips

Conditions: Pilot Study; Clips

Summary: postoperative gastrointestinal complications following esd, emr, and eftr procedures, such as gastrointestinal bleeding, diverticula, fistulas, perforations, and stent fixation, can be effectively treated through gradual endoscopic procedures. the technical limitations of traditional endoscopic hemoclips restrict their application. although endoscopic suturing techniques are emerging, most are still in the exploratory phase. therefore, the investigators have developed metal-reinforced teeth for hemoclips. this initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. the investigators also aim to explore the uses and limitations of this technology. the primary outcomes are the technical success rate and the clinical success rate.

with the advancement of endoscopic technology, gastrointestinal defects following endoscopic submucosal dissection (esd), mucosal resection (emr), and full-thickness resection (eftr), as well as complications such as gastrointestinal bleeding, diverticula, fistulas, perforations, and even fixation of esophageal stents, can gradually be treated through endoscopic procedures. this approach avoids surgical incisions and reduces patient recovery time. traditional endoscopic hemoclips have limited application due to constraints such as arm extension distance, size of the clip's front teeth, and closing force. therefore, the investigators have developed metal-reinforced teeth for hemoclips. this initial clinical study aims to validate the safety, feasibility, and effectiveness of reinforced teeth in clinical applications. the investigators also aim to explore the uses and limitations of this technology. the primary outcome measures include technical success rate and clinical success rate. additionally, the investigators closely monitor procedure time, the number of clip uses during the procedure, and postoperative adverse events during follow-ups.

Eligibility criteria:
inclusion criteria: * 1. gastrointestinal lesions that require clips include non-variceal upper gastrointestinal bleeding, post-endoscopic submucosal dissection (esd) lesions in the gastrointestinal tract, fistulas, diverticula, perforations, and anchoring of self-expanding metal stents. * 2. expected survival greater than 30 days; * 3. written informed consent. exclusion criteria: * 1. patients with diffuse gastrointestinal lesions, such as crohn's disease and ulcerative colitis; * 2. patients who clearly require surgical intervention; * 3. serious cardio-pulmonary, hepatic or renal disease; * 4. intolerance to endoscopy; * 5. pregnant or lactating women.

Keywords: clips gastrointestinal diseases metal-reinforced teeth perforation fistula gastrointestinal bleeding
evaluation of post operative pain and success rate after pulpotomy

Conditions: Root Canal Infection

Summary: the aim of this randomized controlled trial is to assess the post-operative pain as primary outcome and the success rate as secondary outcome after pulpotomy using different calcium silicate based materials in mature permanent teeth diagnosed with irreversible pulpitis.

setting and location : out-patients clinic of endodontic department, faculty of dentistry, ain shams university patient allocation: using computer generated randomization (www.randome.org), the participants will allocated randomly into three groups . the sequentially numbers that will be generated, will be placed in opaque envelope until the intervention and each participant will be asked to select an envelope that determine which group of intervention he will be assigned. patient classification: patients will be randomly divided into three groups according to material used in pulpotomy group (1) biodentine (n=20) group (2) theracal pt (n=20) group (3) neoputty (n=20) procedural steps: * pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading on a visual analogue scale (vas) * tooth will be anaesthetized using local anesthesia containing articaine with epinephrine 1:100,000. * rubber dam isolation of tooth * tooth surface disinfection using guaze soaked in 5.25% sodium hypochlorite * access cavity will be performed using a carbide steel round bur and tapered diamond stone until complete deroofing. * using a sterile excavator, the coronal pulp tissue will be excavated14 * cotton pellets soaked in 2.5 % sodium hypochlorite will be used to achieve hemostasis for 2-3 minutes * once hemostasis will be achieved one of the three materials will be placed according to the manufacturer's instructions * final restoration will be placed methods of evaluation 1. post operative pain 2. pulpotomy success rate

Eligibility criteria:
inclusion criteria: * patients age between 20 and 40 years old. * teeth diagnosed with symptomatic irreversible pulpitis. * normal periapical condition confirmed by normal periapical radiograph or that with minimal widening of the pdl space. * the teeth are restorable. * teeth probing depth and mobility should be within normal limits. exclusion criteria: * teeth with immature roots * non restorable teeth * bleeding could not be controlled after pulpotomy in 10 minutes. * medically compromised patients with systemic complication that would alter the treatment.

Keywords: pulpotomy tricalcium silicate biodentine vital pulp therapy
postoperative analgesia in patients with microvascular decompression

Conditions: Trigeminal Neuralgia

Summary: perioperative pain is caused by a variety of harmful factors through multiple mechanisms, therefore, reasonable postoperative analgesia should be combined with drugs or measures of different mechanism , which is called multimodal analgesia. multimodal analgesia could minimize side effects and achieve a better analgesic effect. commonly used strategies of multimodal analgesia are oral analgesic drug, nerve block, patient controlled analgesia and so on. this study will observe the effect of multimodal analgesia on postoperative pain in patients with microvascular decompression and record side effects. finally, it will provide technical support for the guidance of postoperative analgesia in patients of trigeminal neuralgia.

the investigators will collect 90 cases which will be divided into 3 groups. patients in group a will receive scalp nerve block and patient-controlled analgesia which contains sufentanil and ondansetron. in group b, patient-controlled analgesia which contains sufentanil, ondansetron and ketamine will be applied. in group c, patient-controlled analgesia which contains sufentanil and ondansetron will be applied.

Eligibility criteria:
inclusion criteria: 1. patients of trigeminal neuralgia plan to receive microvascular decompression 2. age between 18 and 70, asa classification between ⅰ～ⅲ 3. no severe liver and kidney disease, no blood coagulation dysfunction 4. no history of long-term opioid drugs usage, no drug addiction history 5. patients are fully conscious, cooperation, understanding and voluntarily signed informed consent exclusion criteria: 1. more than 20% of the total blood volume is lost in operation 2. intracranial hematoma happens within 24 h after surgery 3. secondary surgery patients

Keywords: trigeminal neuralgia nerve block
optimization of the patient care pathway in immuno-oncology

Conditions: Melanoma

Summary: this study compares the care pathway of melanoma patients treated by immunotherapy in two ambulatory care structures. the aim is to measure if a care structure specialized in immuno-oncology could rationalize the care of patients. this protocol will be based on two different follow-up during the treatment period: * dedicated and coordinated e-follow-up (iuct-o in toulouse) * standard follow-up (university hospital center in bordeaux) patients will be followed from the first cycle of immunotherapy until 3 months after the initiation treatment.


Eligibility criteria:
inclusion criteria: 1. patient with advanced (unresectable melanoma (stage iii)) or metastatic (stage iv) melanoma and starting an immune checkpoint inhibitor treatment (monotherapy or combination therapy) 2. patient starting first cycle of immune checkpoint inhibitor treatment in an ambulatory care structure 3. treatment which can be delayed for 7 days or more 4. age \> or = 18 years old 5. patient with a phone and/or computer equipment 6. patient affiliated to the french social security system 7. patient must provide written informed consent prior to any study-specific procedure or assessment exclusion criteria: 1. patient with diagnosis other than advanced melanoma 2. patient who must receive a treatment other than immune checkpoint inhibitor 3. treatment administered during a conventional hospital stay (period of more than 24 hours) 4. patient with no caregiver 5. pregnant or breastfeeding women 6. any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure 7. patient protected by law

Keywords: advanced melanoma immune checkpoint e-follow-up
phase i drug-drug interaction of omega-3 and atorvastatin

Conditions: Hyperlipidemia, Hypertriglyceridemia

Summary: this study evaluates the safety and pharmacokinetic drug-drug interactions of omega-3 and atorvastatin in healthy male volunteers. half of the participants will receive omega-3 for 16 days to be steady state of omega-3 and followed by omega-3 and atorvastatin in combination for 7 days. the other half will receive atorvastatin for 7 days to be steady state of atorvastatin, and followed by atorvastatin and omega-3 in combination for 16 days.


Eligibility criteria:
inclusion criteria: * 50kg or less of body weight and body mass index of 18 \~ 30kg/m² * no congenital or chronic disease requiring treatment, and no pathological symptoms or findings as a result of medical examination * eligible for the clinical trial as a result of a clinical laboratory test, 12-lead ecg, v/s test at the screening exclusion criteria: -
fat and transcapillary insulin transport

Conditions: Lipid-induced Insulin Resistance

Summary: there is a current debate whether impaired insulin-mediated microvascular perfusion limits the delivery of hormones and nutrients to muscle and whether short term ffa elevation affects transcapillary transport of insulin and glucose thereby representing a rate-controlling step for insulin-stimulated muscular glucose disposal in humans. to address these questions, the investigators determined the changes of interstitial glucose and insulin in skeletal muscle of healthy volunteers during intravenous administration of triglycerides or glycerol under physiologic and supraphysiologic hyperinsulinemic conditions.

increased lipid availability reduces insulin-stimulated glucose disposal in skeletal muscle, which is generally explained by lipid induced inhibition of myocellular insulin signalling, it remains unclear whether lipids also impair transcapillary transport of insulin and glucose which could thereby become rate-controlling for glucose disposal increased accumulation and availability of lipids cause impaired skeletal muscle insulin sensitivity. it is yet unclear if transcapillary transport of insulin and glucose is impaired by acute elevation of free fatty acids and represents a rate-limiting step during the development of short-term lipid-induced insulin resistance. we determined the changes of interstitial glucose and insulin in skeletal muscle of healthy volunteers during intravenous administration of triglycerides and heparin or glycerol under physiologic and supraphysiologic hyperinsulinemic conditions.

Eligibility criteria:
inclusion criteria: * the volunteers have to be older than 19 years, * nonobese (body mass index, bmi less than 27 kg/m2), * normolipidemic (fasting serum concentration of triglycerides \< 140 mg/dl and * total cholesterol \< 200 mg/dl) and * non-smokers. exclusion criteria: * the following exclusion criteria will be applied: * any medication within two weeks prior to the start of study, * regular alcohol consumption \> 40 g/d, * acute inflammatory disease defined by serum c-reactive protein \> 1 mg/dl, * abnormalities in the screening visit or in laboratory tests considered as clinically relevant, * family history of diabetes mellitus or dyslipidemia, * glucose intolerance, * allergy or hypersensitivity against study medication, * blood clotting disorders.

Keywords: insulin resistance vascular impairment diabetes
ganglionic local opioid analgesia at the ganglion cervicale superius

Conditions: Trigeminal Neuralgia, Idiopathic; Postherpetic; Neuralgia, Trigeminal (Etiology); Glossopharyngeal Neuralgia; Atypical Facial Pain

Summary: the blockade of the superior cervical ganglion (gcs) of the sympathetic trunk is a very special form of therapy. the transoral blocking technique, also known as gloa (ganglionic local opioid analgesia), is very suitable for achieving gcs. a total of 5 μg of sufentanil in 2 ml of sodium chlorid are applied. since no imaging evidence of the injected substances has been published for a gloa in a living person, it is planned to carry out an mri examination immediately after the ganglionic local opioid analgesia in order to show the spread and distribution pattern of the injected substance. it is also planed to show a correlation of the spread of the injected substance with the efficacy of the intervention. to determine the interrater reliability, the gloa is carried out alternately by 2 different examiners and the existing mri images of the gloa are assessed by an radiologist and anatomist in a blinded manner. in a follow-up after 1 and 3 months, the questionnaires and pain scores are evaluated again.

the blockade of the superior cervical ganglion (gcs) of the sympathetic trunk is a very special form of therapy. it is successfully used for numerous, often protracted diseases that severely impair the patient's quality of life, such as idiopathic facial pain syndromes or trigeminal neuralgia. the transoral blocking technique, also known as gloa (ganglionic local opioid analgesia), is very suitable for achieving gcs. with this technique, a sprotte cannula is inserted into the pharyngeal recess (rosenmueller) located behind the palatopharyngeal arch and pierced through the pharyngeal wall into the parapharyngeal space. a total of 5 μg of sufentanil in 2 ml of sodium chlorid are applied. since no imaging evidence of the injected substances has been published for a gloa in a living person, it is planned to carry out an mri examination immediately after the ganglionic local opioid analgesia in order to show the spread and distribution pattern of the injected substance. it is also planed to show a correlation of the spread of the injected substance with the efficacy of the intervention. for this, different questionnaires (nrs, quality of life, sleep quality, patient satisfaction) are carried out before and after the intervention. to determine the interrater reliability, the gloa is carried out by 2 different examiners and the existing mri images of the gloa are assessed by an radiologist and anatomist in a blinded manner. in a follow-up after 1 and 3 months, the questionnaires and pain scores are evaluated again.

Eligibility criteria:
inclusion criteria: * trigeminal neuralgia * postherpetic neuralgia * glossopharyngeal neuralgia * atypical facial pain exclusion criteria: * psychosis * language barrier * pregnant and breastfeeding women * seizure disorders (epilepsy) * increased risk of bleeding

Keywords: gloa, mri,
uro-bcg-4 : bladder tumors immunotherapy

Conditions: Bladder Cancer

Summary: evaluation of maintenance bcg immunotherapy (dose 27 mg) in superficial bladder tumors. two randomized arms (every 3 or 6 months) will be studied for a population of 300 patients.

bcg maintenance immunotherapy 1/3 dose : 27 mg two randomized arms : 3 or 6 months for 36 months clinical side effects according to oms score efficacy regarding recurrence : cytology and cystoscopy psa, leucocyturia and n-ramp gene evaluation

Eligibility criteria:
inclusion criteria: * ta and t1 bladder tumors exclusion criteria: * bcg contra-indications
dexamethasone for cerebral toxoplasmosis

Conditions: Toxoplasmosis, Cerebral

Summary: toxoplasma gondii infects over one third of the global human population. cerebral toxoplasmosis is the most common opportunistic infection in hiv patients resulting in up to 50% of mortality with proper treatment and 80% without it. the fatality mainly due to the brain edema resulted from the mass effect lesion. in addition of anti toxoplasmosis given, adjunctive therapy such as steroid is recommended in order to reduce brain edema, but the dose and duration of administration in cerebral toxoplasmosis has not been evaluated in a clinical trial. adjunctive therapy given in cerebral toxoplasmosis patients still remains unclear. moreover, its safety in immunodeficiency cases is still debatable.

steroid produces a raising expression of anti inflammation genes (nf-κb, iκb-α and antagonist receptor il-1) and inhibits pro inflammation cytokines ( tnf-α and il-1β). it also works as anti edema by correcting the disrupted blood brain barrier during infection process. dexamethasone is considered to be chosen in this clinical trial due to the long half life among steroids, the strongest glucocorticoid effect comparing other steroids, and easily prepared and used on daily practice. there are limited data from using adjunctive steroid for treatment of hiv-associated with cerebral toxoplasmosis. previous study in france published in 2012 showed steroid did not give any significant improvement for patients' neurological outcome and did not worsen patients' condition such as getting nosocomial infection. meanwhile comparing previous study by arens et. al in 2007, there was an increasing mortality rate on adjunctive steroid used in cerebral toxoplasmosis patients. as result of limited data, our trial is looked forward to answer about the efficacy of dexamethasone treatment in reducing mortality rate of cerebral toxoplasmosis patients.

Eligibility criteria:
inclusion criteria: 1. age 18 years or above. 2. clinical signs and symptoms compatible to cerebral toxoplasmosis 3. serology hiv positive 4. immunoglobulin g anti-toxoplasma titre is positive 5. one or more mass lesions on the neuroradiological finding 6. none or less than 3 days of dexamethasone therapy taken 7. written informed consent from the patients or from close relatives of the patient if the patient is unconscious. exclusion criteria: 1. history of anti-toxoplasmosis administrattion for more than 5 days before recruitment 2. hypersensitivity or other contraindication to dexamethasone 3. pregnancy
peek versus silicon interspinous spacer for reduction of supradjacent segment degeneration

Conditions: Adjacent Segment Degeneration

Summary: a retrospective study that aims to report adjacent segment degeneration (asd) incidence and spinopelvic balance in short lumbosacral instrumentation for degenerative lumbar spinal stenosis. although asd is a common complication following lumbar fusion, the effect of an interspinous spacer (is) in the supradjacent segment in short lumbosacral instrumented fusion and its interaction with spinopelvic balance has not been studied adequately.

methods from 55 consecutive age-, diagnosis- and gender- matched patients aged 60±11 years, 17 (group r) received peek is; 18 (group s) received silicon is and compared with 20 controls (group c) without receiving any is. the functional outcome was evaluated with vas and odi. spinopelvic balance was evaluated using sva, t12-s1 ll, ss, pt, pi and supradjacent segment disc heights. all spines were preoperatively balanced.

Eligibility criteria:
inclusion criteria: preoperative mri with degeneration grades\<iii at the 1st supradjacent lumbar segment. exclusion criteria: * body mass index≥40kg/m\*m * severe osteoporosis * lumbar fracture * preoperative sva\>4cm * spondylolisthesis grades\>ii or spondylolytic lesion and acquired spinous process insufficiency in the supradjacent segment cephalad to instrumentation

Keywords: spinopelvic alignment short lumbosacral instrumentation peek silicon spacer
construction of microfluidic exosome chip for diagnosis of lung metastasis of osteosarcoma

Conditions: Osteosarcoma; Pulmonary Metastases

Summary: use exosome microfluidic chips to establish a combination of exosome subgroup level (exosome barcode) markers for the early diagnosis of osteosarcoma lung recurrence, and establish the basis of microfluidic chip based exosome biomarker for monitoring the early therapeutic response of the second-line therapy for recurrent osteosarcoma.

osteosarcoma is the most common primary malignant bone tumor in adolescents, and lung metastasis is the main cause of its poor prognosis. our previous data on the basis of second-line chemotherapy combined with vegfri targeted therapy for patients with lung metastases from osteosarcoma showed that some patients with early diagnosis of lung metastases may achieved long-term tumor-free survival upon prompt treatment. however, plasma biomarker for the early detection of recurrent osteosarcoma is still lacking to date. our preliminary studies indicate that exosome is a potential source of liquid biomarker for the early diagnosis of osteosarcoma lung metastasis. we, therefore, have developed a microfluidic biochip based on nano-zinc oxide microcolumns. this chip can quickly and efficiently screen and capture exosomes and achieve quantitative and qualitative detection of exosome and its subgroups. this technology may be able to achieve early sensitive exosome quantification for lung metastasis of osteosarcoma. but the clinical efficacy and utility of the microfluidic chip based exosome detection for the early diagnosis osteosarcoma recurrence remains to be validated. this research plan uses our newly developed microfluidic chip technology to capture and efficiently capture exosomes for quantitative and qualitative and marker screening, and establish a combination of exosome subgroups level as a biomarker for the early diagnosis of osteosarcoma lung metastasis.

Eligibility criteria:
inclusion criteria: 1. biopsy pathologically diagnosed as primary high-grade osteosarcoma (including ordinary osteosarcoma, vasodilatory osteosarcoma, small cell osteosarcoma, high-grade surface osteosarcoma); 2. age no less than 12 years old and no older than 60 years old; 3. new-onset patients who have not received chemotherapy, radiotherapy, surgery, chinese medicine and other treatments. 4. the primary site is the limbs and pelvis. exclusion criteria: 1. pathological diagnosis of surgical gross specimens except primary high-grade osteosarcoma; 2. failure to collect circulating exosomes as planned; 3. suffering from chronic diseases, which may lead to an increase in non-tumor-related circulating exosomes, such as autoimmune diseases , chronic infections, etc.; 4. the use of targeted drugs may lead to a decrease in tumor-related circulating exosomes; 5. withdrawal from the trial for any reason.