Kornimate/medical-research-clean huggingface dataset:
an open-randomized, balanced, crossover bioequivalence study to compare one mr tablet of 60 mg gliclazide and two mr tablets of 30 mg gliclazide in healthy subjects

Conditions: Hyperglycemia; Diabetes

Summary: the 2 × 2 crossover designed study is to evaluate the bioequivalence of two different mr tablets of gliclazide after single oral administration at the same doses to healthy subjects.

the 2 × 2 crossover designed study is to evaluate the bioequivalence of two different mr tablets of gliclazide after single oral administration at the same doses to healthy subjects.

Eligibility criteria:
inclusion criteria: subjects will be enrolled into the study according to the following criteria: 1. subjects must be male at the age of 20-40 years old in good health on the basis of medical history, physical examination, electrocardiogram, chest x-ray, and routine laboratory evaluations. 2. vital signs (after 3 minutes resting in a upright position) which are within the following ranges: ear body temperature between 35.0-37.5 °c. systolic blood pressure, 90-140 mm hg. diastolic blood pressure, 50-90 mm hg. pulse rate, 50-90 bpm. fasting blood glucose, \< 100 mg/dl. 3. body weight must be greater than 50 kg and within -20 to +20% of ideal body weight. 4. able to sign informed consent prior to study. 5. able to communicate well with the investigator and comply with the requirements of the study. exclusion criteria: subjects meet any of the following criteria during pre-study examination evaluation will be excluded from entry into or continuation in the study: 1. use of any prescription medication within 14 days prior to dosing. 2. use of over-the-counter medications or vitamins within 14 days prior to dosing. 3. significant illness within 2 weeks prior to dosing. 4. participation in any clinical investigation within 2 months prior to dosing or longer than required by local regulation. 5. donate or loss more than 500 ml of blood within 3 months prior to dosing. 6. presence of cardiovascular disease. 7. presence of gastrointestinal disease. 8. presence of asthma or lung disease. 9. presence of liver disease, hepatitis b, hepatitis c or liver injury as indicated by an abnormal liver function profile such as got, gpt,gama-gt, alkaline phosphatase, serum bilirubin, hbsag, or anti-hcv. 10. presence of impaired renal function as indicated by abnormal creatinine or bun values or abnormal urinary constituents (e.g., albuminuria). 11. presence of neurological disease. 12. presence of psychiatrical disease. 13. subject is known for hiv infected. 14. a known hypersensitivity to gliclazide or its analogs. 15. history of drug or alcohol abuse within 12 months prior to dosing. 16. permanent confinement to an institution. 17. individuals are judged by the investigator or pharmacokineticist to be undesirable as subjects for other reasons.

Keywords: hypoglycemic drug
periodontal regeneration with recombinant human platelet derived growth factor (rh-pdgf-bb) and allograft

Conditions: Periodontal Diseases

Summary: growth factors are defined as small proteins that trigger a cellular response after binding to cell receptors; tissue engineering is now clinically applicable in a commercially available system involving the use of recombinant human platelet-derived growth factor. the objective of this study is to evaluate clinical and radiographic parameters in bone defects treated with platelet-derived growth factor in combination with allograft. our hypothesis: defects treated with dfdba and rhpdgf-bb have better clinically and radiographic results that the defects treated with dfdba and saline solution.

the study will be performed in 30 periodontal defects of 2 and 3 walls. the experimental group will consist of dfdba placement with rhpdgf-bb and control dfdba with saline solution. the clinical parameters recorded were probing deep (pd), clinical attachment level (cal), recession depth, index of bleeding and plaque at baseline and at six months. our universe is patients with periodontitis attending at the clinical in periodontics at the autonomous university of nuevo leon (uanl) school of dentistry.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of periodontitis * infrabony defects of 2 walls, 3 walls and combined defects * patients asa (american society of anesthesiologists) i and ii * patients who smoke less than 10 cigarettes exclusion criteria: * patients undergoing bisphosphonate therapy * furcation defects * patients with evidence of blood dyscrasias. * pregnant patient

Keywords: periodontal regeneration grow factors intraosseous defects
duration of doxycycline treatment in mem patients

Conditions: Erythema Chronicum Migrans

Summary: the purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.


Eligibility criteria:
inclusion criteria: • multiple erythema migrans exclusion criteria: * pregnancy or lactation * immunocompromised * serious adverse event to doxycycline * taking antibiotic with antiborrelial activity within 10 days * extracutaneous manifestations of lyme borreliosis
ia or pe - what is the best treatment option of steroid refractory neurological autoimmune diseases

Conditions: Neurological Autoimmune Diseases

Summary: in this prospective controlled monocentric observational study, we assessed safety and efficacy of therapy with ia or pe in patients with neurological autoimmune diseases. in the subgroup analysis of ms patients also the edss was evaluated. in addition, we investigated possible pathomechanisms, such as cytokine alterations under therapy.

plasma exchange (pe) and immunoadsorption (ia) are first- or second line treatment options in patients with neurological autoimmune disease, including multiple sclerosis, neuromyelitis optica, chronic inflammatory demyelinating polyneuropathy, acute inflammatory demyelinating polyradiculoneuropathy (guillain-barré-syndrom) or autoimmune encephalitis. this prospective controlled monocentric observational study of patients treated with either tryptophan ia or pe in cases of autoimmune neurological therapy refractory disease was performed between 2016 and 2019. the main outcome parameter for efficiency was clinical improvement after completion of treatment with pe/ia. symptoms were assessed before the first and after the last ia/pe. in total, all patients receive 5 treatments. as patients with various neurological autoimmune diseases were included in the study, the overall treatment response was categorized descriptively as improvement or no improvement of symptoms.

Eligibility criteria:
inclusion criteria: * autoimmune neurological therapy refractory disease exclusion criteria: * intake of angiotensin-converting-enzyme inhibitors (ace inhibitors) because of allergic reactions by using tryptophan adsorber * contraindication for any anticoagulation * contraindication for treatment with citrate dextrose anticoagulation

Keywords: plasma exchange (pe) immunoadsorption (ia) multiple sclerosis neuromyelitis optica, chronic inflammatory demyelinating polyneuropathy acute inflammatory demyelinating polyradiculoneuropathy autoimmune encephalitis
effect of kinesiotape on emesis in pregnant women

Conditions: Emesis Pregnancy

Summary: this study will be conducted to investigate the effect of kinesiotaping on emesis in pregnant women.

emesis gravidarum (eg) is a common condition among pregnant women, with a prevalence of 12.5% worldwide. it has a significant impact on the body where the mother becomes very weak, the face is pale and the frequency of urination decreases drastically so, the body fluids are reduced, and blood becomes thick (hem concentration). this condition can slow down blood circulation so that oxygen and food supply to the tissues are also reduced which can cause tissue damage and endangers the health of the mother and her fetus. also, eg known to reduce a woman's quality of life (qol). it was reported that 80% of women with emesis have reduced qol. women with eg fear from the use of the antiemetic drugs and the possible side effects such as drowsiness, sedation, arrhythmia, poor efficacy of pharmacological approach in the past leads to difficulty in the treatment of nausea and vomiting during pregnancy. non- pharmacological option has been proposed to be effective in the treatment of eg and hyperemesis gravidarum. such as hypnosis, acustimulation, tactile massage, psychotherapy, acupuncture and kinesiotape. kinesiotape is a drug-free and an elastic therapeutic tape used for treating various musculoskeletal problems such as injury, pain, and dysfunction and a variety of other disorders. the kinesiotaping was found to be effective in stimulation of large and small intestinal peristalsis. due to lack of previous studies that examined the effect of kinesiotape on eg. this raises the need of further studies in this issue which will give an insight about the efficacy of kinesiotape as a safe, non-invasive and inexpensive method used to alleviate nausea and vomiting during pregnancy. this will be of valuable benefits in medical service organization and increase body of knowledge of physical therapists in scientific field.

Eligibility criteria:
inclusion criteria: * fifty pregnant women at 6th to 12th weeks of gestation diagnosed with mild to moderate nausea and vomiting. * the diagnosis of eg is confirmed by rhodes index. * their ages will be ranged from 20 to 35years old. * their body mass index will be less than 30 kg/m2. * all of them are primigravida. exclusion criteria: * digestive system diseases, inflammatory bowel disease, gastric ulcers and/or esophagitis. * twins or more. * obese women with bmi \<30 kg/m2. * severe emesis or hyperemesis gravidarum. * risk of threatened or habitual abortion. * multi gravida. * thyroid or liver dysfunction.
hospital based group intervention for breast cancer patients.

Conditions: Breast Cancer; Anxiety; Depression; Quality of Life; Coping

Summary: incam-study is a multicenter, prospective, randomized controlled trial. the aim of the study is to test the effectiveness of psychoeducative intervention when offered in hospital setting as a component of routine breast cancer care. the hypotheses are; - that breast cancer patients participating in psychoeducative interventions focusing on coping will experience better health-related quality of life than those who participate in the hospital standardised psychoeducative intervention. - that coping styles are associated with the immune system.

women operated for breast cancer often experience psychosocial problems for several years. although, meta-analyses have clearly demonstrated that the efficacy of psychosocial support groups, little is known about the effectiveness of this intervention when offered in the hospital setting as a component of routine breast cancer care. a few studies have found that psychological intervention reduce emotional distress and enhance immune responses,but if there is an association between coping styles and immune system is not clear. 440 breast cancer patients at two hospital will be randomized into the study. both hospital have standardised psychoeducative interventions as a component of routine breast cancer care. both hospital will have two groups, the standardised groups and the experimental groups. participants will answer the same standardised questionnaires before surgery,2,6,12 months and 3 and 5 years after the interventions. blood sample will be drawn at all assessments. the questionnaires are the hospital anxiety and depression scale, the mini-mental adjustment to cancer scale, the eortc qlq-br32, the life orientation test-revised. all groups are facilitated by two nurse specialists and follow a structured program. the standardised groups consists of three weekly 2-hours sessions and the experimental groups will consists of six weekly 2-hours session. the intervention protocol has been approved by the norwegian committee for medical research ethics. knowledge from this study will be used to develop a manual for hospital based group interventions for breast cancer patients.

Eligibility criteria:
inclusion criteria: verified breast cancer diagnosis age 18 years or more but under 75 years - exclusion criteria: diagnoses of metastatic breast cancer do not read or write norwegian diagnoses of mental retardation, severe or untreated psychopathology, dementia diagnoses of any immunologic condition or disease -
sentinel node biopsy in breast cancner: omission of axillary clearance after micrometastasis

Conditions: Breast Cancer

Summary: sentinel node (sn) biopsy in breast cancer has been demonstrated to be a reliable method, and several follow-up studies have shown that it is safe to refrain from completion axillary clearance (axillary lymph node dissection, alnd) in sn-negative patients. sn biopsy alone results in significantly less arm discomfort following the operation. however, as a surprisingly low frequency of axillary relapse has been observed in patients without any axillary intervention (neither sn biopsy nor axillary clearance), or without completion alnd after a positive sn biopsy, the importance of alnd is being questioned, even for patients with sn metastases. a large, randomized study (isbcg23-1) was not able to show any differences in 5-year disease-free survival between patients with sn micrometastases who had undergone alnd and those who had not. this swedish multicenter study will include patients with sn micrometastases. these women will not undergo alnd but will be registered in a study cohort. the patients will otherwise be treated in accordance with the national guidelines and will be clinically followed every year for five years, after 10 years and finally after 15 years. hypothesis: to refrain from axillary clearance in breast cancer patients with sentinel node micrometastases does not impair survival.

from april 2017 onwards, only patients operated by mastectomy or those receiving neoadjuvant therapy and having a sentinel node biopsy before its initiation may be recruited into senomic. the inclusion target has been met for those patients operated by breast-conserving therapy, and from now on, these patients will not be included in senomic anymore. recruitment of the above-mentioned patient selection will continue until 452 patients operated by mastectomy have been enrolled.

Eligibility criteria:
inclusion criteria: * patients with clinically node-negative, invasive breast cancer ≤ 5 cm (t1-t2) * histopathology results demonstrate sn micrometastases. * patients who undergo mastectomy (protocol change from april 2017 onwards) * the patient must have given verbal and written consent. exclusion criteria: * preoperatively diagnosed lymph node metastases. * sentinel node metastases \> 2 mm. * metastases beyond the ipsilateral axillary lymph nodes at the time of surgery. * history of previous breast cancer. * pregnancy. * bilateral breast cancer where any of the other exclusion criteria applies to either side. * medical contraindication for systemic adjuvant therapy

Keywords: breast cancer sentinel node biopsy micrometastasis axillary lymph node dissection
efficacy and safety of scm-cgh in patients with steroid-refractory or dependent chronic graft-versus-host disease

Conditions: Chronic Graft-versus-host-disease

Summary: the purpose of this study is to evaluate efficacy of scm-cgh in participants with steroid dependent/refractory chronic graft versus host disease (cgvhd) by measuring overall cgvhd response (complete response \[cr\] and partial response \[pr\] defined by national institutes of health \[nih\] consensus development project criteria \[2014\]).


Eligibility criteria:
inclusion criteria: * subjects who are males or females aged \>= 19 years, 40kg to 80kg in weight * steroid dependent/refractory chronic graft versus host disease (cgvhd) defined as the national institutes of health (nih) criteria (2014) below at any time post-hematopoietic cell transplant (post-hct): refractory disease, defined as, 1) when cgvhd manifestations progress despite the use of a regimen containing glucocorticoid (prednisolone at \>=1 mg/kg/day for at least 2 weeks) or 2), 3) persist without improvement despite continued treatment with glucocorticoid (prednisolone at \>=0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks dependent disease, defined as, 4), 5) when glucocorticoid (prednisolone doses greater than or equal to \[\>=\] 0.25 milligram per kilogram per day (mg/kg/day)or \>=0.5 milligram per kilogram (mg/kg) every other day) are needed to prevent recurrence or progression of manifestations as demonstrated by unsuccessful attempts to taper the dose to lower levels on at least 2 occasions, separated by at least 8 weeks. * participants must be receiving less than 3 systemic glucocorticoid therapies or other immunosuppressive therapies in addition to glucocorticoids for cgvhd for at least 4 weeks before screening visit. the dose of steroids or immunosuppressant must be stable for 14 days(2 weeks) prior to starting scm-cgh or placebo. * laboratory test sufficiency as follows; absolute neutrophil count (anc) ≥ 1,000 cells/mm3 serum creatinine \< 2 x upper limit of normal (uln) exclusion criteria: * active acute graft versus host disease (gvhd) * active infection with human immunodeficiency virus (hiv), hepatitis b virus, or hepatitis c virus (hcv) * uncontrolled underlying disease such as moderate or severe infections and hemorrhage * severe heart failure (nyha class iii/iv), congestive heart failure or arrhythmia requiring treatment * history of allogenic hematopoietic stem cell more than once * positive reaction of a penicillin test at screening * history of relapse of causative diseases (all, cml, cll, aml, nhl, multiple myeloma e.t.c.) with hematopoietic stem cell transplantation or diagnosed with secondary malignant diseases after hematopoietic stem cell transplantation * history of anti-thymocyte globulin(atg) for 2 weeks before screening visit * history of pulmonary embolism or deep venous thrombosis for 24 weeks before screening visit
a study to evaluate the efficacy and safety of abt-493/abt-530 in adults with chronic hepatitis c virus genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis

Conditions: Hepatitis C Virus Infection; Chronic Hepatitis C; Compensated Cirrhosis

Summary: the purpose of this study is to assess the safety and efficacy of abt-493/abt-530 following 12 weeks of treatment in adults with chronic hepatitis c virus infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.


Eligibility criteria:
inclusion criteria: * screening laboratory result indicating hepatitis c virus (hcv) genotype 1, 2, 4, 5 or 6 (gt1,2,4,5,6) infection * chronic hcv infection * subject must be hcv treatment-naïve or have failed prior hcv treatment * subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease exclusion criteria: * positive test result at screening for hepatitis b surface antigen or anti-human immunodeficiency virus (anti-hiv) antibody * hcv genotype performed during screening indicating co-infection with more than 1 hcv genotype * consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive abt-493/abt-530

Keywords: hcv genotype 1 hcv genotype 4 hcv genotype 2 cirrhotic interferon-free compensated cirrhosis hcv genotype 5 hepatitis c hcv genotype 6
lung recruitment and peep effects on intracranial pressure in cranial surgery

Conditions: Intracranial Pressure Increase; Mechanical Ventilation Complication

Summary: high positive end-expiratory pressure (peep) levels required to achieve clinical benefits may increase icp and reduce cerebral perfusion pressure (cpp) in patients at risk of intracranial hypertension. however, individualizing ventilation parameters is essential for each patient. among protective ventilation strategies, peep is key to preventing alveolar collapse. the peep level that minimizes alveolar collapse while avoiding overdistension of the pulmonary parenchyma is known as the best peep. this study aims to evaluate the application of best peep in cranial neurosurgery.

in general anesthesia for neurosurgery, mechanical ventilation is the standard approach. however, mechanical ventilation can induce pulmonary parenchymal injury through various mechanisms, including volutrauma, barotrauma, and atelectrauma. these correspond to lung damage caused by high tidal volumes, elevated airway pressures, repetitive alveolar collapse, and reopening. protective ventilation strategies include limiting tidal volume (vt), applying positive end-expiratory pressure (peep), and performing alveolar recruitment maneuvers (arm). historically, both arm and higher levels of peep have been avoided in neurocritical patients, including those undergoing neurosurgery, due to concerns about their potential impact on intracranial pressure (icp) and cerebral perfusion pressure (cpp). as postoperative pulmonary complications can significantly alter the prognosis of surgical patients, increasing hospital stay and healthcare costs, and, in neurocritical patients, compromising cerebral oxygenation, protective ventilation strategies may play a critical role in patients undergoing neurosurgery. their historical exclusion from studies lacks demonstrated physiological justification. here, the investigators aim to evaluate the impact of intrathoracic pressure on icp in neurosurgical patients.

Eligibility criteria:
inclusion criteria: * asa classification i-iii. * elective cranial neurosurgery. exclusion criteria: * asa classification iv or higher. * documented intracranial hypertension. * severe pulmonary disease (e.g., asthma, copd). * emergency surgery.

Keywords: positive end expiratory pressure intracranial pressure