Kornimate/medical-research-clean huggingface dataset:
long-term effects of repetitive tms in chronic neuropathic pain in people with sci

Conditions: Spinal Cord Injuries; Neuralgia; Chronic Pain

Summary: around 80% of people with spinal cord injury (sci) develop chronic neuropathic pain (cnp). this is a debilitating condition with major negative impacts on people's quality of life. many treatment options have been offered (invasive stimulation, drugs) but provide limited effects and many secondary effects. there is a critical need to develop a new generation of therapies. transcranial magnetic stimulation (tms) is a non-invasive and painless brain stimulation technique that allows researchers to explore and change brain excitability that has shown promising effects in neuropathic pain. however there is not enough evidence of what are the long lasting effects of the different protocols. in this study, 30 sci subjects with cnp in their hands will participate in the study. the objective is to evaluate the efficacy of real versus sham repetitive transcranial magnetic stimulation (rtms) and investigate 1) short and long term effects on pain and 2) the behavioral and neurophysiological qualities of responders and non-responders to this treatment.this will be a randomized sham controlled trial with two groups: real or sham high frequency repetitive tms protocol (20hz). the protocol will be done daily for two weeks. clinical, functional and neurophysiological evaluations will be assessed at baseline, post intervention and at 6-week follow up.


Eligibility criteria:
inclusion criteria: * presence of chronic neuropathic pain at or below sci level for at least 6 months following trauma or disease of the spinal cord. * cervical lesion. * cnp in the upper extremity. * pain intensity of at least 4 out of 10 in the numerical rating scale (nrs) in the nps both screening (baseline) and randomization (pre-evaluation).both screening (baseline) and randomization (pre-evaluation). * stable pharmacological treatment for at least 2 weeks prior to the study and throughout the trial. * complete or incomplete lesion. exclusion criteria:

Keywords: spinal cord injuries neuropathic chronic pain transcranial magnetic stimulation neural plasticity pain
fast and accurate breast cancer diagnosis using nanopore sequencing in tanzania (fast-abcd sequencing)

Conditions: Breast Cancer Invasive

Summary: this pilot study will test the feasibility of using nanopore sequencing for breast cancer diagnosis in tanzania. it aims to show that nanopore sequencing is non-inferior to the current standard of care, with the potential for faster and more cost-efficient results. by enhancing the speed and accuracy of diagnosis, this approach could improve treatment planning and outcomes for patients in resource-limited settings.

excess fresh tissue samples from patients with suspected breast cancer will undergo nanopore sequencing alongside the current standard of care (soc), which includes histopathology and biomarker analysis for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (her2) status. low-pass whole genome sequencing and dna methylation-based classification will potentially enable the diagnosis of invasive ductal breast cancer in a cost-efficient and highly accurate manner. additionally, breast cancer subtypes can be determined using methylation signatures and her2 focal amplification, with results available within hours in a point-of-care setting. the primary outcome measures are non-inferiority compared to soc, turnaround time, and overall feasibility. treatment is not altered due to results of the nanopore sequencing.

Eligibility criteria:
inclusion criteria: * patient with suspected diagnosis of breast cancer undergoing biopsy or surgical resection after specialist consultation as per institutional guidelines * excess fresh tumor sample * written informed consent exclusion criteria: * unable to provide informed consent * patients who have already commenced therapy for bc (except for treatment other than biomedicine, e.g. herbal medicines)

Keywords: nanopore sequencing breast cancer
stress ulcer prophylaxis of intravenous esomeprazole in chinese seriously ill patients

Conditions: Stress Ulcer Prophylaxis

Summary: the efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper gi bleeding.

stress related upper gastrointestinal (gi) bleedings are important events associated with morbidity and mortality among seriously ill patients. data from the literature suggest that stress ulcer prevention with effective acid suppressive treatment can reduce bleeding events and is thus an important therapy in high-risk patients. esomeprazole has the potential to reduce gastric acidity for prolonged periods of time adequate for both preventing mucosal damage and facilitating coagulation. this study is to reveal whether intravenous (iv) esomeprazole is effective in preventing upper gastrointestinal bleeding and if it is tolerated by chinese seriously ill patients.

Eligibility criteria:
inclusion criteria: 1. critically ill patients 2. requirement for mechanical ventilation 3. at least one major risk factor for stress ulcer related bleeding exclusion criteria: 1. history of gastric or oesophageal surgery 2. evidence of active gi bleeding 3. advanced renal disease 4. treatment with any proton pump inhibitors

Keywords: sup upper gi bleeding seriously ill patients
role of subcutaneous negative pressure suction drain placed for ten days on wound healing in obese patients undergoing midline laparotomies

Conditions: Postoperative Wound Healing

Summary: the aim of the study is to evaluate the role of subcutaneous negative pressure drain placed for 10 days on wound healing in female obese patients undergoing midline exploratory laparotomies for ovarian cancer.


Eligibility criteria:
inclusion criteria: * bmi more than 30kg/m2 * midline laparotomies * ovarian cancer exclusion criteria: * associated medical disorders
dynamic monitoring of ctdna and hpv dna in plasma for the early prediction of recurrence after cervical cancer surgery

Conditions: cfHPV DNA in Plasma of Cervical Cancer Patients

Summary: assess the sensitivity, specificity, positive predictive value, and negative predictive value of dynamic monitoring of circulating tumor dna (ctdna) combined with circulating hpv dna (cfhpv dna) for early prediction of recurrence in cervical cancer post-surgery or post-treatment, and compare its advantages and disadvantages with existing diagnostic methods.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosed hpv-positive cervical malignancy at stages i-iv who have not undergone surgery, radiation therapy, or chemotherapy. * patients must be older than 18 years of age. * cervical cancer patients who are eligible for surgery and/or chemoradiotherapy. * estimated life expectancy of more than three months. * understands the study protocol and voluntarily participates in the research by signing the informed consent form. * able to provide specimens and corresponding clinical information at each time point. exclusion criteria: * patients who are participating in other clinical trials. * pregnant or breastfeeding women. * patients with severe mental illness. * patients who voluntarily withdraw. * patients unable to complete the study protocol.

Keywords: cfhpv dna cervical cancer
photobiomodulation of orthodontic mini-implants by a 635nm diode laser

Conditions: Malocclusion, Angle Class II

Summary: the study aimed to estimate clinically an influence of 635nm diode laser on the primary and secondary stability of orthodontic mini-implants placed in a maxilla, to assess mini-implants failure rate (mini-implant loss) and to evaluate a pain level after the treatment. the randomized clinical split-mouth trial included 15 subjects, 30 implants (dual top anchor system, seoul, korea) with a diameter 1.4mm and length of 10mm. mini-implants were placed in the area of the attached gingiva between the second premolar and first molar teeth 2 mm below the mucogingival junction of both sides of the maxilla in 15 patients.


Eligibility criteria:
inclusion criteria: * patients with class ii malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant; * the patients were treated first time using fixed orthodontic appliance; * no systemic diseases; * were not using anti-inflammatory drugs; exclusion criteria: * had used antibiotics in the previous 24 months; * smokers; * had history of radiotherapy, * taking bisphosphonate medication

Keywords: atp, biostimulation, micro-screw, periotest, semiconductor laser
feasibility of ultrasound microbubble contrast-enhanced (ceus) sentinel lymph node imaging with guided biopsy in breast cancer patients

Conditions: Breast Cancer

Summary: the goal of this clinical research is to learn if an ultrasound contrast agent called optison (perflutren protein type a) is effective in finding sentinel lymph nodes before surgery. contrast agents can help make ultrasound images more accurate. the sentinel lymph node is the first node that may be the target of cancer cells that spread from the tumor.

study procedures: if you agree and are eligible to take part, you will receive perflutren protein type a by injection under the skin near the nipple. after you receive the injection, the radiologist will take more ultrasound images and videos of the tumor and lymph nodes in the underarm area. you will have a biopsy of the sentinel lymph node that was identified in the ultrasound and a titanium clip marker will be inserted into the node. the clip helps distinguish the biopsied node from other nodes. you will be told the results of biopsy. after the biopsy, a radioactive seed may be inserted into the node to allow the surgeon to find and remove it during your surgery, an extra node may be removed at that time. you will still have standard of care sentinel lymph node biopsy during your already scheduled surgery. you will sign a separate surgical consent form that explains this procedure and its risks. you will be called by phone 30 days after the seed is removed to check for any side effects. this phone call should take about 10 minutes. length of study: your active participation in this study will be over the follow up phone call. this is an investigational study. perflutren protein type a is fda approved and commercially available for use in contrast-enhanced echocardiograms. its use in this study is investigational. up to 21 patients will take part in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. 18 years or older. 2. ipsilateral biopsy-proven invasive breast cancer \<5 cm in maximal dimension by ultrasound or mammography. 3. no abnormal axillary nodes identified on grayscale aus, or abnormal nodes with benign subsequent fna biopsy. exclusion criteria: 1. pregnant or nursing women 2. prior sln dissection 3. neoadjuvant chemotherapy. 4. prior axillary lymph node surgery. 5. prior history of ipsilateral breast cancer. 6. known or suspected: cardiac shunts 7. known or suspected: hypersensitivity to perflutren, blood, blood products or albumin 8. known or suspected: hypersensitivity to a prior optison administration

Keywords: breast cancer microbubble contrast-enhanced ultrasound ceus sentinel lymph nodes sln perflutren protein-type a microspheres injectable suspension optison™ ultrasound breast biopsy radioactive seed phone call fine needle aspiration fna
efficacy and tolerance of naked dna vaccine in patients with chronic b hepatitis

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to determine if dna vaccination of chronic hbv patients under treatment with nrti can restore t-cell responsiveness and delay virologic reactivation after treatment discontinuation.

despite the availability of effective vaccines against hepatitis b, over 370 million people worldwide remain persistently infected with hbv. persistent infection is associated with chronic liver disease that can lead to the developement of cirrhosis and hepatocellular carcinoma in two-third of persons. treatment of chronic hepatitis b relies on the use of analogs such as lamivudine, adefovir, entecavir or immunostimulators such as interferons. although analogs are efficient, genotypic resistance occurs after one year of treatment and the rate of virologic relapse is high after treatment discontinuation. hbv is a non cytopathic virus and liver damage is caused by immune response against infected hepatocytes and to a non specific inflammatory response. immune response contributes to the virus clearance. in acute hepatitis b infection, t cell response is polyclonal, specific and vigorous, whereas in patients with chronic infection, responses remain weak, less specific and hardly detectable in peripheral blood. t cell responses could be induced or restored by antigenic stimulation such as vaccination. in a previous phase i clinical trial, we showed that dna vaccination with plasmid pcmvs2.s is safe and can specifically, but transiently activate t-cell responses in chronic hbv-carriers not responding to current antiviral therapies. analogs such as lamivudine and adefovir were shown to enhance t cell responses concomitantly with viral load decrease. in this phase i/ii clinical trial, we would like to determine if dna vaccination of chronic hbv patients under treatment with nrti can restore t-cell responsiveness and delay virologic reactivation after treatment discontinuation.

Eligibility criteria:
inclusion criteria: * chronic hepatitis b with or without aghbe * no cirrhosis and no hepatocellular carcinoma * treatment with nrti unchanged for at least 3 months * undetectable hbv viral load for 12 months * hbv viral load \< 12 iu/ml at screening * sgpt \< 5n * tetanus immunization or booster dose for less than 8 years * accurate birth control or menopausal women or sterility * sickness insurance * signed informed consent exclusion criteria: * hla-dr 15/16 * coinfections with hdv, hcv and/or hiv * treatment with immunomodulators * immunosuppressors * long-term corticotherapy (over 4 weeks) * active intravenous drug-users * prolonged and excessive consumption of alcohol (men \> 40g/day ; women \> 30g/day ; for more than 5 years) * medical history of autoimmune disease or presence of autoantibodies * previous immunization by hbv vaccine of less than 5 years * previous immunization by dna vaccine against hbv * personal or family medical history of demyelinising diseases * uncontrolled hypophosphatemia * renal failure, renal transplantation, haemodialysis * pregnancy, breast-feeding

Keywords: dna vaccine
iga nephropathy, lymphocyte homing and iga class switch

Conditions: IgA Nephropathy

Summary: iga nephropathy (igan) is the most common primary glomerulonephritis in the world and it represents an important cause of end-stage kidney failure. this disease was described as a distinct entity in 1968 by j berger and n hinglais. the aetiology and the pathogenesis remain still obscure. clinical observations and immunisation studies indicate that igan represents a dysregulation of the immune system, rather than an intrinsic renal abnormality. twenty years ago, some authors proposed the mucosa-bone marrow axis to explain the pathogenesis of the disease. mucosal iga plasmocytes are displaced and take up residence in systemic sites. the unusual characteristics featured by the iga produced by these cells (charge, size, glycosylation) drive their accumulation, deposition and mesangial activation characteristic of igan. evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant localization.


Eligibility criteria:
inclusion criteria: * age \> 18 and \< 70 years * iga nephropathy documented by the kidney biopsy in the six months preceding the inclusion * glomerular filtration rate (mdrd formula as simplified) \ 30 ml/mn/1,73 m2 * consent form signed exclusion criteria: * patients with cirrhosis or chronic liver disease * patients with a history of crohn's disease or celiac disease * patients who received treatment with corticosteroids or affiliates for six months * patients who received a live attenuated vaccine during the past 4 weeks * patients with a known infection such as hiv, hepatitis b or c * patients who presented with a serious infection during the last month * breastfeeding women * patients not affiliated with a social security scheme * under guardianship patient
efficacy of tak-438, amoxicillin and clarithromycin in the first line eradication of h. pylori

Conditions: H. Pylori Infection

Summary: the purpose of this study is to confirm the efficacy of triple therapy with tak-438, amoxicillin and clarithromycin, twice daily (bid) by demonstrating its non-inferiority to triple therapy with lansoprazole, amoxicillin and clarithromycin in h. pylori-positive patients with scarred gastric or duodenal ulcers.


Eligibility criteria:
inclusion criteria: 1. participants must be h. pylori-positive patients at baseline (visit 1) 2. participants must be endoscopically confirmed to have scarred gastric ulcer or duodenal ulcer at baseline (visit 1). however, if a history of ulcers is confirmed by the medical interview or previous medical record, participants whose gastric ulcer scar or duodenal ulcer scar has disappeared may be included in the study. 3. outpatient (including inpatient for examination) exclusion criteria: 1. participants who have received h.pylori eradication treatment 2. participants who have either acute upper gastrointestinal bleeding, gastric ulcer \[mucosal defect (with white coating including clot adherence) of 3 mm or larger in size\], duodenal ulcer \[mucosal defect (with white coating including clot adherence) of 3 mm or larger in size\], acute gastric mucosal lesion (agml), or acute duodenal mucosal lesion (adml) on endoscopic examination at baseline (visit 1). however, participants with gastric erosion or duodenal erosion may be included in the study. 3. participants who have received or who are scheduled to undergo surgery which affects gastric acid secretion (ex, resection of upper gastrointestinal tract, vagotomy, etc) 4. participants who cannot be treated with medicinal treatment (ex, perforation, pyloric stenosis or large hemorrhage, etc) 5. participants with a previous or current history of zollinger-ellison syndrome, or other gastric acid hypersecretion disorders 6. participants with hepatic or renal impairment receiving treatment with colchicines 7. participants who have a history of hypersensitivity or allergy to tak-438 (including its excipients), ppis, penicillin antibiotics, macrolide antibiotics, or antitrichomonal agents 8. participants with infectious mononucleosis 9. participants with an organic disease of the brain or spinal cord

Keywords: drug therapy
san diego bleeding esophageal varices study

Conditions: Survival and Control of Bleeding

Summary: in unselected cirrhotic patients with bleeding esophageal varices to compare the influence on mortality rate, duration of life, quality of life, and economic costs of treatment of: * emergency portacaval shunt, and * emergency and long-term endoscopic sclerotherapy.

see attached synopsis - appendix 1

Eligibility criteria:
inclusion criteria: * all patients with ugi bleeding (blood in the esophagus, stomach, or duodenum) who enter the emergency room or develop bleeding while in the hospital or are transferred from nearby hospitals and are suspected of having cirrhosis and bev will be eligible for consideration (all comers). * those who are shown to have the findings of cirrhosis and esophageal varices that: * are seen to be actively bleeding; * have an adherent clot; * have no other associated lesion that could reasonably account for bleeding of that magnitude (such as large gastric or duodenal varices, gu, du, etc) * require 2 or more units of blood transfusion, will be included in the study. exclusion criteria: * none
prospective observational study of trimetazidine influence on mitochondrial metabolism in human heart ventricle

Conditions: Coronary Artery Disease

Summary: trimetazidine (1-\[2,3,4-trimethoxybenzyl\] piperazine dihydrochloride) is a clinically effective antianginal agent. despite these clinical successes, the understanding of trimetazidine's mechanism of action remains incomplete, particularly influence of trimetazidine on mitochondrial function in isolated human cardiomyocytes. the investigators will perform this study to seek possible differences in mitochondrial respiration related to standard preoperative enrolled trimetazidine therapy.

background: different types of medication are used for treatment of ischemic heart disease. one of recently developed drugs is trimetazidine. although it clinical benefits are clear, mechanism by which this occurs is as yet undefined. in few animal studies authors try to define what effects trimetazidine has on both fatty acid and glucose metabolism in heart. data collected from human cardiomyocytes are rare. available data suggest that trimetazidine may act as a potent inhibitor of beta oxidation, with no significant effect on glucose oxidation. objective: primary objective: collection of mitochondrial respiration data using human heart ventricular samples. secondary objective: define possible differences in mitochondrial respiration depending on preoperative trimetazidine usage. methods: regularly scheduled patients for coronary artery bypass grafting surgery who accept to participate in study will be enrolled in further protocol. patients with inclusion criteria and without exclusion criteria will be enrolled in the study. at the end of operation, surgeon will take biopsy sample of left ventricle for mitochondrial function and metabolic activity analysis.

Eligibility criteria:
inclusion criteria: * patients with coronary artery disease who are candidates for coronary artery bypass graft (cabg) surgery. exclusion criteria: * emergency patients, patients who already had heart surgery, patients with acute coronary syndrome in last 2 months, patients with inability to understand patient information and informed consent.
skeletal fragility in type 1 diabetes: glycemic control and bone strength

Conditions: Type1diabetes

Summary: the purpose of this research study is to find out how bones are affected in children and adolescents with type 1 diabetes (t1d) as compared to children and adolescents without type 1 diabetes.

t1d is primarily associated with decrements in bone strength due to disrupted microarchitecture occurring during peak bone mass accrual, and this disruption arises from hyperglycemia and glycemic variability. impaired bone development during this period likely predisposes to an increased fracture risk across the lifespan. the investigators will compare baseline, 12 month and 24 month changes in high-resolution peripheral quantitative computed tomography/micro-finite element analysis (hr-pqct/μfea)-based estimates of bone strength and bone turnover by biochemical measurements in 40 t1d children at the onset of peak bone mineral accretion (n=40) versus sex and puberty-matched healthy controls (n=40). the investigators will determine relationships between changes in bone strength (including trabecular and cortical components) and measures of glycemic control and variability by continuous glucose monitoring (cgm).

Eligibility criteria:
inclusion criteria (t1d and controls): - children within 2 years preceding the onset of the pubertal growth spurt inclusion criteria (t1d participants): - documentation of β-cell autoimmunity and need for insulin replacement exclusion criteria: * estimated glomerular filtration rate (egfr)\< 60 ml/mim * 25(oh)d level \< 20 ng/ml. * celiac disease * autoimmune thyroid disease * addison's disease * history of pathological fractures -- disorders associated with altered skeletal structure or function * bone active drugs in past year * diabetes of other or unclear etiology