Kornimate/medical-research-clean huggingface dataset:
effectiveness and safety of different doses of bi 1026706 in patients with postoperative dental pain

Conditions: Pain, Postoperative

Summary: to investigate the effectiveness of bi 1026706 powder for reconstitution of an oral solution compared to placebo and the relative effectiveness compared to celecoxib.


Eligibility criteria:
inclusion criteria: 1. healthy males according to the investigator's assessment, as based on the following criteria: a complete medical history including a physical examination, vital signs (blood pressure,pulse rate), 12-lead electrocardiogram, and clinical laboratory tests 2. age 18 to 55 years (incl.) 3. body mass index 18.5 to 29.9 kg/m2 (incl.) 4. patients scheduled for removal of one mandibular third molar with partial or complete bony impaction. if medically indicated, the ipsilateral third molar in the upper jaw could also be removed; 5. surgery will be conducted under local anaesthesia using 12% lidocaine (with epinephrine). intravenous sedations and general anaesthetics are not permitted. 6. reliable, cooperative, and of adequate intelligence to record the requested information on the analgesic questionnaire form 7. examined by the attending oral surgeon or physician and medically cleared to participate in the study 8. scheduled to undergo a qualifying surgical procedure 9. signed and dated written informed consent prior to admission to the study in accordance with gcp and local legislation exclusion criteria: 1. any finding in the medical examination (including blod pressure, pulse rate or electrocardiogram) deviating from normal and judged clinically relevant by the investigator 2. repeated measurement of systolic blood pressure greater than 140 mm hg or diastolic blood pressure greater than 90 mm hg 3. any laboratory value outside the reference range that the investigator considers to be of clinical relevance 4. any evidence of a concomitant disease judged clinically relevant by the investigator 5. acute local infection at the time of surgery that could confound the post-surgical evaluation 6. gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders 7. surgery of the gastrointestinal tract that could interfere with kinetics of the study drug(s)
the effect of counterstrain technique on muscle stiffness and pain on trapezius tender points in medical students

Conditions: Counterstrain; MyotonPRO; Tender Points

Summary: medical students are prone to developing neck pain due to prolonged studying and poor posture. this can manifest as tender points in the upper trapezius region. counterstrain (cs) is an osteopathic manipulative technique that has shown efficacy in previous studies in treating tender points. the myotonpro is a myotonometric device that can be used to measure various muscle parameters such as muscle stiffness. there is limited research regarding the use of osteopathic manipulative medicine to produce measurable changes in muscle stiffness by the myotonpro. this educational study aims to establish the efficacy of cs technique in decreasing the pain level of upper trapezius tender points in medical students as well as determining if cs causes a significant decrease in muscle stiffness in treated tender points as measured by the myotonpro. the investigators hope this educational study will encourage further studies on how osteopathic manipulative techniques affects the physiologic parameters of muscles.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age exclusion criteria: * traumatized (sprained or strained) tissues, which would be negatively affected by the positioning of the patient * illness or other conditions in which strict positional restrictions preclude treatment * instability of the area being positioned that has the potential to produce unwanted neurologic or vascular side effects * vascular or neurologic syndromes, such as basilar insufficiency or neural foraminal compromise whereby the position of treatment has the potential to exacerbate the condition * severe degenerative spondylosis with local fusion and no motion at the level where treatment positioning would normally take place * pregnancy * positive for covid-19 as well as symptoms indicating a sars-cov-2 infection

Keywords: counterstrain myotonpro tender points medical students
the prepaird study: personalized surveillance for early detection of pancreatic cancer in high risk individuals

Conditions: Hereditary Pancreatic Cancer

Summary: the objective of this national and multidisciplinary project is to establish and evaluate a personalized surveillance program (sp) for early diagnosis of pancreatic cancer (pc) and its precursors in individuals with a hereditary predisposition to the disease (high risk individuals (hri)). patients who either carry a germline mutation in a pc susceptibility gene (cdkn2a, stk11, tp53, prss1), or have a strong family history of pc, will be enrolled through their genetics clinic at the university hospitals in oslo, bergen, trondheim and tromsø. surveillance consists of annual mri, assessment of blood glucose and lipid levels, new onset diabetes (nod) and unintentional weight loss. blood samples will be drawn for ctdna-analysis (circulating tumor dna) and the immraytm pancan-d test (a novel microarray-based diagnostic test for pc) at baseline and in those who develop lesions. the psychological burden and cost-benefit of the sp will be analyzed. the study addresses an unmet need for the care of hri in norway, and is expected to improve pc prognosis. it will be the first to provide evidence on the combined value of a panel of blood-borne biomarkers in surveillance, and provide morphological and molecular data on pc and (non)-neoplastic pancreatic changes in hri.


Eligibility criteria:
inclusion criteria: 1. men or women with a germline mutation in cdkn2a, tp53, prss1 or stk11 2. men or women who are first degree relatives to a patient with pancreatic cancer (pc) in a family with familial pancreatic cancer (fpc). exclusion criteria: patients undergoing active cancer treatment.

Keywords: surveillance early detection prevention
safety and efficacy of nnc-0156-0000-0009 in haemophilia b patients

Conditions: Congenital Bleeding Disorder; Haemophilia B

Summary: this trial is conducted in africa, asia, europe, japan and north america. the aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of nnc-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia b.


Eligibility criteria:
inclusion criteria: * male patients with moderately severe or severe congenital haemophilia b with a factor ix activity of 2% or below according to medical records * history of at least 150 exposure days to other factor ix products * patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis exclusion criteria: * known history of factor ix inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (lar) interviews * hiv (human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/ml and/or cd4+ lymphocyte count equal to or below 200/microl * congenital or acquired coagulation disorders other than haemophilia b * previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records) * immune modulating or chemotherapeutic medication
a retrospective clinical records review of patients diagnosed with gastrointestinal stromal tumour at two tertiary institutes in singapore

Conditions: Gastrointestinal Stromal Tumors

Summary: to review the characteristics and treatment of gastrointestinal tumours at the two tertiary centres in singapore

a retrospective clinical records review of patients diagnosed with gastrointestinal stromal tumour (gist) in the two tertiary centres in singapore i.e. singapore general hospital and national university hospital. gastrointestinal tumours are the most common soft-tissue tumours of the gastrointestinal tracts. remarkable progress has been made during the last several years in the diagnosis and treatment of gist. understanding of the molecular pathogenesis of gist which is linked to deregulated kit tyrosine-kinase activity has improved diagnosis, such that gist is now more frequently and specifically identified. more importantly, systemic tyrosine kinase inhibitor, imatinib, has been used successfully in the treatment of gist patients with advanced or unresectable disease. gist has been reviewed in the western literature but there is a lack of asian data. the review will help us to better understand the disease in our population.furthermore we will also examine several unresolved issues in the western literature by looking into our local data. these include required duration of imatinib therapy, role of imatinib in the adjuvant setting (application of chemotherapy after macroscopically complete removal of tumour) and role of combination therapies. the medical records of all patients diagnosed with the disease at the two centres will be reviewed. analysis of the results aims to: 1. to compare the characteristics of the gist (epidemiology, site, morphology, immunohistochemistry profile) in our centres compared to the well-published literature. 2. to compare the treatment regimen and results of our centres compared to others 3. to review the role of chemotherapy in the adjuvant settings in the centres.

Eligibility criteria:
inclusion criteria: * patients diagnosed with gastrointestinal stromal tumor.
a study of bortezomib plus gdp in the treatment of refractory and relapsed non-gcb dlbcl

Conditions: Diffuse Large B-cell Lymphoma

Summary: this study is to evaluate the efficacy and safety of bortezomib plus gdp in the treatment of non-gcb dlbcl patients.


Eligibility criteria:
inclusion criteria: 1. histologically proven diffuse large b-cell lymphoma non-gcb subtype. previously treated with 1, and only 1, chemotherapy regimen including an anthracycline and excluding cisplatin, cytarabine, bortezomib and gemcitabine. relapse after cr, less than pr or pr to previous treatment. 2. no history of stem cell transplantation, and no intention for stem cell transplantation. 3. age between 16-75. 4. ecog\<3. 5. at least 1 measurable tumor mass. 6. minimum life expectancy of 3 months. 7. written informed consent. 8. no uncontrolled cns involvement by lymphoma:no cns disease at time of relapse;cns disease diagnosed at initial presentation allowed provided a complete response for cns disease was achieved and maintained. exclusion criteria: 1. chemotherapy or large field radiotherapy within 3 weeks prior to entering the study. 2. clinically significant active infection. 3. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule. 4. any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures. 5. subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. 6. patients who are pregnant or breast-feeding. 7. hiv infection.

Keywords: diffuse large b-cell lymphoma
dexamethasone as adjuvant to bupivacaine in suprazygomatic maxillary nerve block

Conditions: Nerve Block

Summary: postoperative pain score, faces, legs, activity, cry, consolability (flacc) is the primary outcome. the secondary outcomes are the first-time requested analgesia, the number of children required analgesia, the total amount of analgesic requirements during first the 24 hours.

congenital cleft palate (cp) occurs in children at a rate of about 1.5 per 10 000 births , requiring early surgery, during the first months of life. the surgical procedure can be complicated by airway obstruction and respiratory complications. cp is painful in the first 24-48 hours following surgery. different treatment modalities have been used for reducing or ameliorating the pain following cleft palate repair. these include opioids, paracetamol, non steroidal anti-inflammatory drugs (nsaids). however, the analgesic drugs may provide inadequate analgesia and have side effects such as respiratory depression and bleeding. the inherent disadvantages of analgesic pharmacotherapy in children promoted interest in nerve blocking techniques for operative analgesia. the maxillary nerve, the second division of the trigeminal nerve, leaves the cranial part of the face through the foramen rotundum, and then passes forward and laterally through the pterygopalatine fossa, at the bottom of the pterygomaxillary fossa, and reaches the floor of the orbit by the infra-orbital foramen. this sensory nerve supplies innervation of the lower eyelid, the upper lip, the skin between them, the roof of the mouth, and the palate. bilateral infra-orbital nerve block is clearly inefficient for anesthesia of the posterior part of the palate (hard palate). the infrazygomatic route of the maxillary block, useful for trigeminal neuralgia, can present several risks such as penetration of the orbit or the skull and accidental maxillary artery puncture. the palatine nerve block could be efficient for analgesia following cleft palate repair, but the technique requires identifying the first molar, which is absent in infants. finally, submucosal infiltration performed by the surgeon seems to alter surgical conditions. maxillary nerve block using the suprazygomatic approach has demonstrated beneficial effects in adults for trigeminal neuralgia and limits the risks related to the procedure.

Eligibility criteria:
inclusion criteria: * age between 1 and 9 years * children scheduled for primary surgery for soft palate cleft or soft and hard palate clefts * gender: both * asa grade i - ii. * informed consent. exclusion criteria: * parent refusal * history of developmental delay or mental retardation, which will make observational pain intensity assessment difficult * hypersensitivity to any local anesthetics * bleeding diathesis * children with co-morbid conditions like congenital heart disease, respiratory pathology and central nervous system disorders * skin lesions or wounds at the puncture site of the proposed block
laparoscopic cholodochotomy in management of cbd stones

Conditions: Management of CBD Stones

Summary: the aim of this study is to compare the outcomes of primary closure of cholodochotomy incision versus t-tube drainage in laparoscopic common bile duct exploration for management of cbd stones and provide evidence-based guidance to the selection of the most appropriate operative technique.


Eligibility criteria:
inclusion criteria: 1. patients with a definitive preoperative diagnosed with cbd stones. 2. a cbd diameter of ≥1 cm. 3. patients are fit for surgery exclusion criteria: 1. patients with liver cirrhosis. 2. a cbd diameter of \<1 cm 3. malignancy in the biliary tract or cbd stricture . 4. patients are not fit for surgery.
iron supplementation for acute anemia after postbariatric abdominoplasty

Conditions: Anemia, Iron-Deficiency; Weight Loss

Summary: the purpose of this study is to determine whether intravenous or oral iron are effective in the treatment of postoperative anemia and iron deficiency in patients submitted in postbariatric abdominoplasty.

multicenter open randomized clinical trial with allocation ratio 1: 1. 56 adult patients undergoing post- bariatric abdominoplasty will be evaluated. the study group will receive 200 mg of intravenous iron in the immediate postoperative period and a second application on day 1 postoperatively. the control group will receive 100 mg of oral iron twice daily for 8 weeks. haematological variables , iron 's profile , quality of life ( sf -36 and fact- an) and adverse events will be assessed preoperatively and on the first , fourth and eighth weeks postoperatively .

Eligibility criteria:
inclusion criteria: * women * 18 a 55 years * prior open or laparoscopic standard limb roux and y gastric bypass * bmi \< 32 kg/m2 * stability of weight loss for at least 6 months * grade 3 abdominal deformity on the pittsburgh scale exclusion criteria: * illiterate * current smoking * prior iv iron use in the last 3 months * uncontrolled systemic diseases * hemoglobin \< 11 g/dl * ferritin \<11 ng/ml * ferritin \> 100 ng/ml * transferrin saturation \<16% * transferrin saturation\> 50% * b12 \< 210 pg/ml * folic acid \< 3.3 ng/ml * albumin \< 2 g/dl * c reactive protein\> 5 mg/l * prior anaphylactic reaction to iv iron

Keywords: anemia, iron-deficiency bariatric surgery abdominoplasty surgery, plastic iron
genetic counseling for menopausal therapy decision-making for women at increased risk for breast cancer

Conditions: Menopause

Summary: the purpose of this study is to determine the effects of a personalized menopausal therapy risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in healthy women at increased risk for breast cancer.

women with a family history of breast cancer have several menopausal therapy options, including tamoxifen, hormone therapy, alternative medications, or no treatment. this complex decision should be based on each woman's risk to develop breast cancer, menopausal symptoms, preferences, and risks for other conditions. current models in use for menopausal therapy counseling do not include pedigree analysis, personalized risk assessment or genetic testing in this process. the purpose of this multi-center study is to determine the effects of a personalized risk assessment and genetic counseling intervention on knowledge, risk perception, and decision-making in a group of healthy women who had a first-degree relative with breast cancer. intervention participants will be given a personalized risk assessment for breast cancer, heart disease, osteoporosis, and uterine cancer based on family history and personal health data.

Eligibility criteria:
inclusion criteria: * at least one first degree relative with breast cancer * age 40 or older exclusion criteria: * currently taking a menopausal therapy * previous cancer diagnosis (except basal cell carcinoma) * previous diagnosis of atypical hyperplasia * previous diagnosis of lobular carcinoma in situ (lcis) * known carrier of a brca1 or brca2 mutation * personal history of heart disease * \>10% risk of carrying a brca1 or brca2 mutation

Keywords: menopause genetic counseling breast cancer tamoxifen chemoprevention
cell therapy in dilated cardiomyopathy: observational study

Conditions: Cardiomyopathy, Dilated

Summary: using bone marrow mononuclear cell in 24 patients with idiopathic dilated cardiomyopathy

patients with idiopathic dilated cardiomyopathy class ii to iv nyha with ejection fraction \<35% were selected for phase i clinical trial of bone marrow mononuclear cell delivery in the coronary arteries and followed for 6 months

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic dilated cardiomyopathy * optimized therapy and for idiopathic dilated cardiomyopathy * left ventricular ejection fraction (simpson) \< 35% * peak oxygen consumption (vo2 peak) \< 16 ml.kg-1min-1 * functional classes ii-iv of the nyha exclusion criteria: * dilated cardiopathies of ischemic or chagasic origin * primary valve disease * excessive use of alcohol or illicit drugs * pregnancy * ventricular arrhythmias * any co-morbidity with impact on survival
the effect of reinforced endotracheal tube on post-operative hoarseness undergoing thyroidectomy

Conditions: Voice Hoarseness; Sore Throat; Thyroidectomy

Summary: the purpose of this study is an evaluation of the effect of the reinforced endotracheal tube on post-operative hoarseness and sore throat undergoing thyroidectomy


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist physical status 1-3 * patients undergoing thyroidectomy under general anesthesia * tumor size \< 2cm * patient who do not have any problem in the vocal cord exclusion criteria: * patient who is expected difficult intubation (mallampati class 3 or more) * patient who has respiratory disorder * previous hoarseness and sore throat history * obesity (bmi \> 30 kg/m2) * recurrent laryngeal injury during operation * operation history of oral and laryngeal surgery

Keywords: hoarseness sore throat thyroidectomy
retinal ganglion cell function after intravitreous ranibizumab in patients with diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: to evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function.

* ranibizumab can be a safe treatment for diabetic macular edema regarding maintenance of retinal ganglion cell function after repeated intravitreal injections. * to evaluate the safety of intravitreal ranibizumab repeated injections in patients with diabetic macular edema regarding maintenance of retinal ganglion cell function. * the primary endpoint for the study will be the changes in full-field and focal macular photopic negative response (phrn) amplitude (in µv) over time, from baseline to month 12.

Eligibility criteria:
inclusion criteria: * male or female patients, older than 18 years, who have signed an informed consent. * patients with type 1 or type 2 diabetes mellitus and prior diagnosis of diabetic macular edema (dme), who had not undergone any previous treatment, either pharmacological or laser photocoagulation. * patients with visual impairment due to dme whom, in the opinion of the investigator, would benefit from treating with ivr. exclusion criteria: * known hypersensitivity to ranibizumab or any of its components. * previous participation in any clinical studies of investigational drugs within 1 month * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they are using two birth control methods. the two methods can be a double barrier method or a barrier method plus a hormonal method. adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent. * pregnant or nursing (lactating) women. * inability to comply with study or follow-up procedures.

Keywords: diabetic macular edema intravitreal ranibizumab f retinal ganglion cell
trail: treatment of intracranial aneurysms with lvis® system

Conditions: Intracranial Aneurysms

Summary: a prospective, multicenter, observational assessment of the safety and effectiveness of the lvis® device in the treatment of wide necked intracranial aneurysms.


Eligibility criteria:
inclusion criteria: 1. patient or patient's legally authorized representative has been informed about the confidentiality of the study and has agreed to the collection of his/her personal data 2. patient has a ruptured or unruptured intracranial aneurysm for which: * the parent artery has a diameter ≥ 2.0mm and ≤ 4.5 mm; * the aneurysm neck size is ≥ 4mm or its dome-to-neck ratio is \< 2 (wide neck) * endovascular treatment with coils and one or more lvis® devices has been determined necessary for the patient by the multidisciplinary team 3. patient is aged ≥ 18 years 4. patient presents with a wfns score between 0 and 3 5. patient has agreed to attend follow-up appointments exclusion criteria: 1. the use of an endovascular stent other than lvis® has been determined necessary 2. patient presents with medical or surgical co-morbidities limiting his/her life expectancy to less than one year 3. patient has a contraindication to platelet inhibition treatment 4. patient requires retreatment of an aneurysm previously treated with a stent 5. patient is pregnant 6. patient has multiple aneurysms to be treated in one procedure