Kornimate/medical-research-clean huggingface dataset:
endodrill vs. conventional biopsy. diagnostics and genetic analysis

Conditions: Esophageal Neoplasm

Summary: endodrill is a new instrument for biopsy sampling in the gi-channel. the purposes of this study are as follows: * compare the endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis based on collected biopsies of tumors in the upper gi tract. * based on the quality of the collected tissue samples we want to evaluate which instrument generates the most useful material for genetic studies of the tumor.

endodrill is a newly constructed biopsy tool for flexible endoscopic use. it uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. it was originally designed for sampling of tissue from submucosal lesions. the investigators´ first study of the instrument is now finished. endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps. in this study the investigators want to compare the endodrill instrument´s ability to obtain representative tissue samples from tumors in the distal esophagus and cardia with a conventional biopsy forceps. in addition the investigators want to compare the tissue samples in terms of weight, quality, artefacts and whether either instrument is more suited for collecting tissue for genetic analysis. such analysis will be conducted with next-generation sequensing (ngs) of the whole exome, whole exome sequensing (wes). in the event of positive results from these analysis the investigators will also conduct rna-sequencing of the tumor tissue in order to start pre-operative mapping of genetic abnormalities. 20 patients will be enrolled for this study. for each patient the investigators will collect 10 biopsies, 5 biopsies each with conventional biopsy and the endodrill instrument respectively. the order will be randomized for each patient. for each specific biopsy the investigator will choose a particular site on the suspected tumor tissue without knowing which instrument that will be used for the biopsy. this procedure will be repeated for all 10 biopsies.

Eligibility criteria:
inclusion criteria: * patients diagnosed with adenocarcinoma of the distal esophagus/cardia or stomach capable of stating a formal consent to participate in the study. exclusion criteria: * mental illness * extreme co-morbidity (asa \>3)

Keywords: biopsy diagnostics genetic analysis
study of the intraocular pressure (iop)-lowering efficacy of azopt 1.0% compared to timolol 0.5% in patients with glaucoma or ocular hypertension

Conditions: Primary Open Angle Glaucoma; Ocular Hypertension

Summary: this is a multiple-dose study of the iop-lowering efficacy of azopt (brinzolamide) 1.0% compared to timolol 0.5% when added to a prostaglandin analogue (pga) as adjunctive therapy over a 24 hour period in patients with glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * primary open angle glaucoma or ocular hypertension patients exclusion criteria: * women of childbearing potential * history of bronchial asthma, or severe chronic obstructive pulmonary disease * presence of acute glaucoma

Keywords: ocular hypertension patients
associations between periodontitis and autoimmune antibodies in rheumatoid arthritis disease

Conditions: Periodontitis, Rheumatoid Arthritis, Autoimmunity,

Summary: the aim of this case control study is to explore the possible association between periodontal destruction and serum anti-ccp antibodies in ra patients and healthy subjects.

in patients with ra, the anti-ccp antibody titer seems positively correlated to their periodontal destruction and disease activity in comparison with healthy subjects.

Eligibility criteria:

Keywords: dentistry
treatment of insufficient superficial and perforatring veins of the lower limb using hifu

Conditions: Varicose Veins; Veins Diseases; Varicose Ulcer

Summary: this is a one-arm, open label, prospective, single center study to evaluate clinical standardization with theraclion's sonovein 2 hifu device. the original sonovein device was tested in a clinical trial in 50 subjects and received ce mark. that device has been updated yielding the current version of sonovein 2. based on the technical similarities between both devices in term of design, performance and principle of operation, the clinical data for sonovein is sufficient to assure conformity of the sonovein 2 with the respected essential requirements. at the same time, the compagny wishes to pursue the standardisation of the clinical practice with the second generation device and is, therefore, conducting this limited trial in 20 evaluable cases (from the planned 22 patients to be included). a "case" is defined as procedure conducted on a distinct vein.

the sonovein 2 system provides high intensity focused ultrasound (hifu) abaltion of soft tissue. the energy is delievered via an extra-corporeal treatment probe, which includes an imaging system. the high energy ultrasound waves propagate through the skin and are focused on a portion of the target tissue, generating intense heat and causing local cell apoptosis and progressive tissue volume reduction over the following months in the tissue within the focal area. the process is then repeated in a stepwize fashion to destroy the targeted tissues. the sonovein 2 system is comprised of several components, including the console, treatment arm containing the visualization and treatment unit (vtu), a computer with touchscreen user interface. in addition, the sonovein 2 system is intended to be used in conjunction with a disposable cooling and coupling system known as epack.

Eligibility criteria:
inclusion criteria: 1. candidate for venous procedure involving lower limb superficial insufficiency involving reflux in the segment to be treated 2. physical condition allowing ambulation after the procedure 3. availability of the patient for all the follow-up visits 4. targeted tissue reachable for treatment with the device-meaning between 5mm and 26mm below the skin surface 5. age over 18 years of age at the time of enrollment 6. no acute venous thrombosis 7. no complete, or near complete deep vein thrombosis 8. patient has signed a written informed consent 9. targeted structure sonographically visible exclusion criteria: 1. patient is pregnant or nursing 2. known allergic reaction to anesthetic to be used 3. legally incapacitated or imprisoned patients 4. patient's vein target not clearly visible on the ultrasound images (b mode) at the inclusion visit 5. patient participating in another clinical trial involving an investigational drug, device or biologic

Keywords: hifu high intensity focused ultrasound
a long-term safety and efficacy study of verekitug (upb-101) in adult participants with severe asthma (valour)

Conditions: Severe Asthma

Summary: the primary purpose of this study is to evaluate the long-term safety and efficacy of verekitug (upb-101) in participants who complete the valiant study (nct06196879).


Eligibility criteria:
inclusion criteria: 1. completion of the valiant study (upb-cp-04 \[nct06196879\]) per protocol. 2. participant has signed, dated, and received a copy of the institutional review board (irb)/independent ethics committee (iec)-approved written informed consent form (icf) for the lte study. 3. contraceptive use by participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. exclusion criteria: 1. abnormal medical history, physical finding, or safety finding that in the opinion of the investigator may obscure the study data or interfere with the participant's safety. 2. any clinical laboratory test result outside of the reference ranges considered by the investigator as clinically significant and that may obscure the study data or interfere with the participant's safety. 3. participant with a history or evidence of a clinically significant pulmonary condition (other than asthma), including significant restrictive findings on pulmonary function testing, chronic bronchitis, emphysema, bronchiectasis, pulmonary fibrosis, or any other related condition that may obscure the study data (e.g., gastroesophageal reflux and vocal cord paralysis/dysfunction). 4. pregnant or breastfeeding or planning to become pregnant or breastfeed during the study or unwilling to use adequate birth control, if of reproductive potential and sexually active. 5. participants with significant protocol deviations in valiant, assessed at the discretion of the sponsor. 6. participant is unreliable, incapable of adhering to the protocol and visit schedule according to the judgment of the investigator or has any disorder that may compromise their ability to give informed consent.

Keywords: upb-101 verekitug tslp receptor monoclonal antibody valiant valour respiratory tract diseases bronchial diseases asthma lung diseases uncontrolled asthma
the effect of emotional freedom technique on premenstrual syndrome and pain in university students

Conditions: Premenstrual Syndrome

Summary: pms is one of the common menstrual disorders affecting many young women, and according to epidemiological data, approximately 75% of women have pms symptoms and 3-8% have severe pms symptoms. the prevalence of pms was different in different countries, with 34% in china , 72% in turkey , 80% in pakistan and jordan. it was detected in the range of 92% in india and 14.3%-74.4% in india. common premenstrual symptoms include anxiety, lack of concentration, depression, bloating, abdominal cramps, breast tenderness, anger, general body pain, nausea, vomiting, fatigue, decreased concentration, mood swings, headache, anxiety, sleep disturbance, appetite changes. in addition to physical symptoms, studies indicate that individuals reporting pms experience more stress and anxiety, and their sensitivity to depressive symptoms increases due to hormonal fluctuations. studies have shown that mindfulness-based cognitive methods are effective in the treatment of mood disorders such as depression. it is thought that modulating many pms symptoms such as stress and experienced emotional problems through mindfulness-based cognitive methods may be an effective approach for future pms interventions.


Eligibility criteria:
inclusion criteria: * persons with amenorrhea, * pregnancy, * menstrual irregularity, * chronic disease, * mental disorders, * psychiatric disorders, * polycystic ovarian syndrome, * those who have received training on eft before and those who have communication problems will not be included in the study. exclusion criteria: * female students between the ages of 18-25, * who scored 111 or higher on the premenstrual syndrome scale (pmss) * participated in the study voluntarily will be included in the study.

Keywords: emotional regulation, premenstrual syndrome
randomized, placebo-controlled, double-blind, parallel-group, multi-site phase 2b clinical study

Conditions: Onychomycosis

Summary: a randomized, placebo-controlled, double-blind, parallel-group, multi- site phase 2b clinical study to assess the efficacy, safety and tolerability of 8-week regimens of nvxt topical product in patients with mild to moderate onychomycosis

evaluate safety and tolerability of the two regimens of nvxt (treatment groups a and b) in patients with mild to moderate distal subungual onychomycosis of the target toenail.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails). exclusion criteria: * females who are pregnant, lactating or likely to become pregnant during the study.
adjuvant stereotactic pelvic irradiation in endometrial cancer

Conditions: Endometrial Cancer

Summary: stereotactic ablative radiation (sabr/sbrt) will be prescribed to a dose of 30 gy in 5 fractions, once weekly to the pelvis in post operative patients with endometrial cancer.


Eligibility criteria:
inclusion criteria: * patient with histologically confirmed endometrial adenocarcinoma * patient is a candidate for adjuvant pelvic radiation (+/- vault brachytherapy), meeting one of the following conditions: high grade histology or outer-half myometrial invasion with any risk factors or figo stage ii - iiic1. * age ≥18 years. * patients who are to receive adjuvant systemic therapy in addition to pelvic radiotherapy will be eligible provided that there is at minimum a 3-week interval between any radiation treatment and chemotherapy treatments. exclusion criteria: * patient has had prior pelvic radiotherapy. * patient has type ii endometrial cancer histology (ie. serous, clear cell or carcinosarcoma). * patient has a contraindication to pelvic radiotherapy, such as but not limited to a connective tissue disease or inflammatory bowel disease. * patient has a contraindication to ct contrast. * patient has a hip prosthesis.
hypertension monitoring in glioma patients treated with bevacizumab

Conditions: Glioma Patients

Summary: prospective casecontrol study in glioma patients undergoing treatment with bevacizumab (avastin). at present there are no data on the correlation between occurrence of arterial hypertension and clinical outcome in patients with glioma or anaplastic astrocytoma. we will investigate whether glioma patients developing hypertension under bevacizumab treatment have a better outcome in terms of progression free survival, response rate and overall survival than equally treated patients remaining normotensive. moreover, we will describe the dynamics of change in blood pressure after administration of bevacizumab in those patients developing hypertension. * trial with medicinal product


Eligibility criteria:
inclusion criteria: patients aged 18 or older with histological diagnosis of anaplastic astrocytoma (who grade iii) or glioma (who grade iv) assigned to bevacizumab treatment (monotherapy or adjunctive to chemotherapy) for therapeutic reasons by an oncologist patients should be on a stable or decreasing dose of steroids willingness and ability to comply with the protocol patient should present with a kps of \>=70 signed informed consent exclusion criteria: previous anti-angiogenic drugs other than bevacizumab allergy or hypersensitivity against bevacizumab contraindications to bevacizumab according to the summary of product of characteristics unwillingness to comply with regular assessments of response and performance of study-related procedures any condition considered relevant for proper performance of the study or risk to the patients, at the discretion of the investigator
a study on the outcome and its influencing factors in patients with borderline personality disorder

Conditions: Borderline Personality Disorder

Summary: borderline personality disorder (bpd) is a difficult chronic mental illness. this diagnosis is common in western countries. our researchers want to study the outcome and its influencing factors of bpd for the first time in china. patients with bpd who had been hospitalized in wuhan mental health center were selected as the subjects. the researchers retrospectively collected the most recent hospitalization data of these patients, and then prospectively follow up them for 2 years to see how their condition will change. by analyzing all data, researchers hope to know deeply about the development law of this illness, and to provide evidence for releasing these patients' suffering.

this study is an ambispective cohort study. the information collected in the retrospective part mainly included demographic data, comorbid psychiatric diagnosis, psychotherapeutive and pharmacotherapeutive data, times of hospitalization and patients' contact information. the above data were derived from electronic medical records. after informed consent, prospective follow-up was initiated primarily by telephone interviews and web-based questionnaires, or by in-person assessments at hospital return visits. enrolled patients will be followed up at 6-month intervals after the first follow-up to assess psychiatric diagnosis, social function, and quality of life. the researchers are senior psychiatrists, all of whom received training on the use of questionnaires and inter-investigator consistency before the follow-up. cox proportional hazard model is used to analyze the influencing factors of remission of bpd, and generalized estimating equation model is used to analyze the influencing factors of the patients' social function and quality of life.

Eligibility criteria:
inclusion criteria: * diagnosis of bpd based on icd-10 (f60.3) exclusion criteria: * comorbidity with severe physical disease * comorbidity with neurological diseases such as epilepsy * comorbidity with mental retardation
effect of buccal fat pad derived stem cells in maxillary sinus augmentation

Conditions: Alveolar Bone Loss

Summary: in this study the buccal fat pad derived stem cells (bfpscs) will be harvested from buccal fat pad tissue of patients receiving maxillary sinus augmentation. in the test group the patients receive a combination of platelet rich fibrin (prf) and freeze dried bone allograft (fdba) (sureoss, hansbiomed, korea) loaded with bfpscs. the results will be evaluated by cone beam computed tomography (cbct)and hematoxylin and eosin staining in 6 months.

the buccal fat pad derived stem cells (bfpscs) is harvested from buccal fat pad tissues. the bfpscs will be loaded on freeze dried bone allograft (fdba) (sureoss, hansbiomed, korea). furthermore, twenty milliliters of the venous blood is obtained, placed and collected in a sterile tube, and centrifuged (gac medical) for 14 minutes at 2800 rpm (approximately 400 g). following centrifugation, three layers are separated in the tube: cellular plasma at the top, platelet rich fibrin (prf) clot in the middle and red blood cells at the bottom of the tube. the prf clot is separated by a sterile pincette. the patients in the test group receives bfpscs loaded on dfdba with prf for sinus augmentation and the control group receives combination of prf and dfdba (lacking any cells).the results will be evaluated by cone beam computed tomography (cbct) in 6 months and microscopic evaluation of the biopsies by hematoxylin and eosine staining.

Eligibility criteria:
inclusion criteria: 1. patients with posterior maxillary edentulism 2. pneumatized sinus 3. less than 5mm bone height between the alveolar crest and sinus membrane exclusion criteria: 1. smoking 2. history of malignancy 3. radiation 4. chemotherapy 5. pregnancy 6. systemic diseases contradicting dental and surgical treatments 7. conditions or drugs affecting bone remodeling or bone metabolism and connective tissue 8. allergy to collagen
a study of the effects of risperidone and olanzapine on blood glucose (sugar) in patients with schizophrenia or schizoaffective disorder

Conditions: Schizophrenia; Diabetes Mellitus

Summary: the purpose of this study is to assess and compare how risperidone and olanzapine, two antipsychotic medications, affect the regulation of glucose (sugar) in the body.

the newer antipsychotic medications risperidone and olanzapine effectively treat schizophrenia and related disorders, and they may cause fewer side effects than the older antipsychotic drugs do. however, some of the newer antipsychotic medications could have a negative effect on the regulation of blood glucose (sugar) in the body. this negative effect could make the patient gain weight and even develop diabetes mellitus. this randomized, double-blind study will assess and compare how risperidone and olanzapine affect the regulation of glucose in the body in patients with schizophrenia and schizoaffective disorder. patients will be randomly assigned to receive risperidone (target oral dose of 6 milligrams per day) or olanzapine (target oral dose of 20 milligrams per day) for 6 months. repeat laboratory measurements will be performed and questions will be asked of the patients to evaluate the safety and effectiveness of the drugs. the primary laboratory test used to assess the patient's regulation of blood glucose will be the disposition index derived from the frequently sampled intravenous glucose tolerance test. risperidone 2 milligram oven-encapsulated tablets taken orally once a day for 6 months; olanzapine 5 milligram tablets taken orally once a day for 6 months

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or related disorder * stable with respect to disease symptoms and other medical conditions * would benefit from this type of antipsychotic drug * if female, using birth control. exclusion criteria: * patients who are delirious, bipolar, severely mentally retarded, or suicidal * psychiatric diagnosis of disease unrelated to schizophrenia * presence of stroke, brain tumor, parkinson's disease, or diseases that affect blood glucose control * history of diabetes * long or recent history of taking risperidone, olanzapine, quetiapine, clozapine, or investigational drugs * recent history of unstable thyroid function * if female, not using birth control * abusing drugs or alcohol.

Keywords: schizophrenia blood glucose glucose metabolism diabetes mellitus risperidone olanzapine
feasibility of short-term prep uptake for msm with episodic high-risk for hiv

Conditions: Human Immunodeficiency Virus

Summary: this study is designed to investigate the acceptability, perceived need and uptake of short-term episodic pre-exposure prophylaxis (prep) for hiv prevention among men who have sex with men (msm). the overall objective is to determine the feasibility of a clinic-based epi-prep implementation pilot project for 50 msm (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.

this proposed study is designed to investigate the acceptability, perceived need and uptake of short-term episodic pre-exposure prophylaxis for hiv prevention among men who have sex with men (msm). long-term prep may be unnecessary for the many hiv-uninfected men who have episodic contextually defined high-risk periods, particularly when away from their home setting. alternative dosing strategies, such as short-term fixed-interval episodic prep (epi-prep), may be a more realistic, feasible, acceptable, and useful option with high public health impact for the majority of msm. the overall objective is to determine the feasibility of a clinic-based epi-prep implementation pilot project for 50 msm (25/each of the 2 study sites) who report occasional condomless sex and who anticipate a period of high-risk while away from home (e.g. vacation) during the study period.

Eligibility criteria:
inclusion criteria: * self-identify as msm: (1) born male who (2) has sex with men * age: 18 or older * sexual risk: has had condomless anal sex with 2 or more men or any transactional sex with a man within the past 12-months. * vacation: identified an upcoming period of episodic risk away (i.e. vacation) from their home city that will last at least 7 but not more than 14 days during which they anticipate having at least one high-risk sexual event. * able and willing to provide informed consent exclusion criteria: * hiv positive * glomerular filtration rate \< 60 ml/min (calculated using the cockcroft-gault formula) * hepatitis b surface antigen positive * symptoms suggestive of acute hiv seroconversion at screening or enrollment * have used prep or pep within the previous 3 months * currently enrolled in another study involving medications, investigational drug, or medical device * has other conditions (based on opinion of investigator or designee) that would preclude informed consent, make the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with study procedures

Keywords: prep hiv msm men having sex with men episodic prep adherence episodic hiv risk