Kornimate/medical-research-clean huggingface dataset:
understanding, modulation and memorization of indicators associated to peri-implantitis

Conditions: Peri-Implantitis

Summary: communication strategies are encouraged to enhance patients´ understanding of potential events related to implant therapy such as peri-implantitis. moreover, it is key to provide accurate information to patients receiving dental implants to reduce false expectations and to minimize the alterations concerning satisfaction. information leaflets based in the "health-belief model" proved efficiency in improving health judgments, decisions and behaviors, in particular when supplemented with visual aids. hence, it was the purpose of the present study to test the effectiveness of different communication strategies to enhance and modulate the understanding and memorization of risk indicators associated to peri-implantitis. a prospective randomized controlled three-arm study is being conducted in accordance with the declaration of helsinki on human studies. three groups are defined to test the hypothesis that visual aids improve the understanding, modulation and memorization of peri-implantitis and related indicators as follows: * test group1 - leaflet with visual aid (l-va): information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included (supplementary figure 1). relevant scientific bibliography supported the statements. along, pictograms were supplemented to display the prevalence of disease with and without the known indicator. * test group2 - leaflet with visual aid (l-nva): information concerning etiology, prevalence, risk indicators and preventive measures of peri-implantitis were included (supplementary figure 2). relevant scientific bibliography supported the statements. no pictograms were supplemented. * control group - no leaflet (nl): only verbal information was provided to the patient during initial interview. patients will be randomly assigned to the tests or control groups according to the last digit of their chart number. as such, patients with records ending 1-4, 4-7 and 8-0 were included in test group1, test group2 and control group, respectively. when reached the total sample size of any of the groups, patients were only recruited for the remaining groups to complete the total sample size. a questionnaire based on the "health-belief model" will be collected from every eligible patient at baseline, 3- and 6-month follow-up


Eligibility criteria:
the following inclusion criteria were applied: partially or completely edentulous patients aged 18-80 years and rehabilitated with implant-supported, single-crown fixed prostheses or implant-supported overdentures; smokers or non-smokers; absence of infectious disease at the time of implant placement; and absence of systemic disorders or medications known to alter bone metabolism. subjects were excluded if they were pregnant; presented uncontrolled medical conditions or diseases (i.e., diabetes mellitus with hba1c level \>8); or presented zygomatic or pterygoid implants. patients with treated peri-implantitis/mucositis were likewise excluded.
community-based neuroendocrine tumor (net) research study

Conditions: Gastroenteropancreatic Neuroendocrine Tumors

Summary: the purpose of this trial is to assess time to disease progression of patients with locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors treated with lanreotide depot. this is an observational study therefore all data collected will be in accordance with the routine practice of physicians.


Eligibility criteria:
inclusion criteria: * histologically confirmed locally advanced or metastatic, well-differentiated neuroendocrine tumor (net) of the small bowel, stomach, colon/rectum, or pancreas (low or intermediate grade; i.e. g1 or g2) * treatment with lanreotide depot (somatostatin analogue-naïve patients and patients with prior treatment with octreotide long-acting repeatable (lar) are permitted) * radiographically measurable disease * has signed the most recent written patient informed consent form exclusion criteria: * known hypersensitivity to lanreotide * poorly differentiated or high grade carcinoma, or patients with neuroendocrine tumors not of lung or thymic origin * patients who have previously initiated treatment with lanreotide depot prior to the start of the study cannot have progressed between lanreotide initiation and study entry * significant history of uncontrolled cardiac disease (ie, myocardial infarction within 6 months prior to enrollment or has congestive heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities)
analyses of exosomes in the cerebrospinal fluid for breast cancer patients with suspicion of leptomeningeal metastasis.

Conditions: Breast Cancer; Leptomeningeal Metastasis

Summary: this is a multicenter, interventional, prospective study among breast cancer patients with a suspicion of metastatic meningitis. the current study aims to assess the use of proteomic profile issued from cerebrospinal fluid microvesicles for diagnosis of leptomeningeal metastases.

the aim of this study is to describe the association between the initial proteomic profile issued from cerebrospinal fluid microvesicles and the initial cytological analysis of the cerebrospinal fluid in breast cancer patients with a suspicion of metastatic meningitis. other objectives of the study include: * describing the association between the initial proteomic profile and: * the histological types and hormonal receptors status of the breast cancer, * the likelihood of leptomeningeal metastasis according to the eano-esmo classification (lack of evidence / possible / probable / confirmed) , * the likelihood of leptomeningeal metastasis according to the eano-esmo classification, combined with histological type and hormonal receptors status. * evaluate the prognostic value of the proteomic profiling for overall survival, according to the eano-esmo classification and other known prognosis factors, in patients classified "possible", "probable" or "confirmed" leading to leptomeningeal metastases specific treatment, * evaluate the impact of the evolution of the proteomic profile a month after the start of this treatment on the overall survival, in patients with leptomeningeal metastases specific treatment, * evaluate the association between the proteomic profile and the eano-esmo classification at least 3 months after the initial eano-esmo classification, * evaluate the evolution of the proteomic profile 3 months after the initial eano-esmo classification, in patients initially classified "lack of evidence", broadly and according to the evolution of cytology, the administered treatments and to the eano-esmo response if applicable, * compare the proteomic profiles issued from cerebrospinal fluid and blood

Eligibility criteria:
inclusion criteria: * patient with histologically proven breast cancer * patient with suspected metastatic leptomeningitis * age ≥ 18 years * patient covered by the french social security regime * signed written informed consent exclusion criteria: * history of cancer other than the one being treated * contraindication to carrying out the lumbar puncture or cerebrospinal mri * pregnant or breastfeeding patient

Keywords: cerebrospinal fluid proteomic profile
clinical trial of shugan jieyu capsule in generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: this is a randomized double-blind placebo-controlled phase 3 clinical trial to further validate the effectiveness and safety of shugan jieyu capsules in treating generalized anxiety disorder.

this trial was a multi-center, randomized, double-blind, two-stage clinical trial in patients with generalized anxiety disorder (tcm differentiated as liver qi stagnation and spleen deficiency syndrome), consisting of a exploratory study(stage 1) and a confirmatory study(stage 2). in stage 1, 120 subjects were enrolled and randomly assigned to high-dose group, low-dose group and placebo group at a ratio of 1:1:1. in stage 2, 495 subjects were randomly assigned to the experimental and placebo groups at a ratio of 1:1.

Eligibility criteria:
inclusion criteria: 1. primary diagnosis of generalized anxiety disorder (gad) as per diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) as confirmed by the mini at screening, the duration of illness must be ≥ 6 months； 2. age 18-65 years old； 3. hamilton anxiety rating scale (ham-a) total score of ≥ 14 at both screening and baseline，anxious mood (item 1) score ≥2； 4. clinical global impression of severity scale (cgi-s) score of ≥ 3 at both screening and baseline 5. the tcm syndrome is liver qi stagnation and spleen deficiency syndrome. exclusion criteria: 1. diagnosed with a psychiatric disorder other than gad that meets dsm-5 criteria within 6 months prior to screening； 2. alcohol or drug abuse or dependence in the 6 months prior to screening, or urine positive for multiple drugs combined at screening 3. hamilton depression rating scale (hamd-17) total score of \> 17 at screening or baseline，or depressive mood (item 1) score ≥2； 4. patients with severe insomnia.
2nd-line treatment of metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: this phase 2 trial aims to evaluate the continued use of bevacizumab with raltitrexed and oxaliplatin combination versus folfox6 plus bevacizumab in patients with metastatic colorectal cancer whose disease has progressed after irinotecan-based chemotherapy.

eligible patients are randomly allocated to receive either bevacizumab with raltitrexed and oxaliplatin combination or bevacizumab with folfox 6 combination. random allocation schedule is performed using a minimization technique for the following stratification factors: * center * number of metastatic sites: 1 versus \> 1 * bevacizumab-based first-line therapy: yes versus no

Eligibility criteria:
inclusion criteria: * histologically proven colorectal cancer * resected or asymptomatic primary tumor * metastatic colorectal cancer not eligible for curative surgery * no major surgery within four weeks of the start of study treatment * at least one target lesion unidimensionally measurable on cross-sectional imaging according to recist criteria (v1.1) * disease progression after failure of irinotecan-based chemotherapy * bone metastases are allowed if there is at least one other measurable metastatic site * ct scan of the abdomen, chest and pelvis within 3 weeks of the start of study treatment * who ps ≤ 2 * platelet count \>= 100,000 mm3 * hemoglobin \> 10g/dl * bilirubin \< 1.5 uln, ast/alt \< 5 uln * serum creatinine \ 60 ml/min (cockcroft) * a time period of 4 weeks should be respected between the end of previous treatments and study enrollment * negative pregnancy test in women of childbearing potential * male or female using an effective contraceptive method * absence of known or symptomatic brain metastases * life expectancy \> 3 months * informed consent signed prior any study specific procedures exclusion criteria: * prior raltitrexed-based chemotherapy * prior oxaliplatin-based chemotherapy (except for adjuvant treatment completed for more than 6 months) * uncontrolled arterial hypertension defined as systolic pressure \> 150 mm hg or diastolic pressure \> 100 mm hg * malignant hypertension or hypertensive encephalopathy * myocardial infarction, pulmonary embolism, or severe vascular disease within 6 months prior to study entry * hemorrhagic diathesis or significant pathology of coagulation * peripheral neuropathy grade\>2 (nci-ctc v4.0) * hemoptysis \< 1 month * venous access device (pac) or any other minor surgery such as a biopsy within the last 7 days * symptomatic brain metastases or carcinomatous meningitis * history or presence of other cancer within the past 5 years (except curatively treated nonmelanoma skin cancer and in situ cervical cancer) * severe bacterial or fungal infection (grade \> 2 nci-ctcae v.4.0) * known or suspected sensitivity to one of the study drugs * pregnant or breastfeeding women * previous enrollment in an investigational drug study within the last 4 weeks * psychological, social, geographical disorders or any other condition that would preclude study compliance (treatment administration and study follow-up)

Keywords: unresectable metastases
the application of thermal stimulation on functional recovery of stroke patients

Conditions: Stroke

Summary: in literature review, thermal stimulation (ts) intervention is effective in facilitating upper extremity functional recovery in stroke patients. in addition, several functional mri studies have indicated that thermal stimuli promoted activation in the premotor and motor cortices of healthy participants. these imply the possibility of ts in cortical reorganization. however, there were no studies exploring the relationship of the ts intervention and cortical reorganization. by the functional recovery of stroke patients, findings of brain image and brain mapping, it could enhance the understanding the ts influences on brain reorganization. regarding with clinical application of the ts intervention for improving functional performance of upper extremity in participants with stroke, the best parameters of ts intervention in clinical practice have not been decided. therefore, this five-year study recruited three groups of stroke patients (acute, sub-acute, chronic) undergoing ts intervention with different parameters. functional scales, kinematic data, brain image were taken in several timelines as outcome measures.

the thermal stimulation (ts) intervention uses the heat and cold apply alternately (\~30minutes), and this kind temperature application is common in clinical neuromuscular or sports rehabilitation. moreover, some studies have proved efficacy of the ts on stroke. however, the best parameters and application on different-stage stroke groups have not been clearly explored. moreover, in order to discover the ts intervention influences on neuroplasticity, the brain images and the brain mapping are taken in the group a (explained in the below). in addition, the kinematic data was also collected in group a. however, the above-mentioned three examination are optional. finally, functional recovery measurements (clinical scales) are measured in the three groups. there are three groups (90 participants in each group) and their respective ts intervention design. in other word, three sub-studies (a, b, c) are under this project. group a recruited 90 acute stroke (\~ 30 days) and the independent variable is temperature of ts intervention. group b is with sub-acute stroke (3-12 months), undergoing different frequency of ts intervention. group c targets on participants with chronic stroke (\> 1 y/o) and this variation in ts is intensity of ts application (30 mins vs 60 mins/each session).

Eligibility criteria:
inclusion criteria: 1. first-ever ischemic stroke; 2. no severe cognitive impairments and able to follow instructions; 3. sit on a chair for more than 30 minutes independently. exclusion criteria: 1. musculoskeletal or cardiac disorders that potentially interferes with experimental tests; 2. diabetic or sensory impairment that attributable to peripheral vascular disease or neuropathy; 3. speech disorder or global aphasia; 4. skin problems at the sites of stimulation; 6.contraindications of heat or ice application.

Keywords: stroke effects of ts in u/e motor recovery brain mapping kinematics analysis
handihaler® vs. metered dose inhaler (mdi) in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: trial to compare the administration technique for handihaler® vs. mdi, to compare the learning retention of the administration technique for the handihaler® vs. mdi and to compare the ease of use for handihaler® vs. mdi


Eligibility criteria:
inclusion criteria: * diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: * historical data (not older than 6 months) of stable airway obstruction with an forced expiratory volume at one second (fev1) ≤ 80% of predicted normal and fev1 ≤ 70% of forced vital capacity (fvc) * male or female patients with 40 years of age or older * smokers or ex-smokers with a smoking history of more than 10 pack-years * currently using a prescription bronchodilator (such as atrovent®, berodual®, combivent®, salbutamol, etc.) administered at least once daily * able to read and understand written instructions, understand verbal instructions and fill out written questionnaires regarding the devices * able to give informed consent prior to participation in the trial, including discontinuation of any medications, sign an approved consent form, and be willing and able to complete all trial procedures exclusion criteria: * any acute or chronic illness which could interfere with the conduct of completion of the trial, including but not limited to cardiovascular, renal, neurologic, liver, immunologic, or endocrine dysfunction if clinically significant * current or recent (past 2 years) history of drug or alcohol abuse * participation in any other clinical trial or use if any investigational drug within the last 30 days prior to visit 1 * experience with the handihaler® * discontinued use of regularly prescribed use of mdi within the last 12 months. * treatment with any oral or injectable β-blockers within the recent 4 weeks prior to visit 1 * treatment with oral β-adrenergics within the recent 4 weeks prior to visit 1 * current or recent (last 6 weeks prior to visit 1) respiratory illness including, but not limited to upper or lower respiratory tract infections or asthma * patients who are in a pulmonary rehabilitation program or who had completed a pulmonary rehabilitation program in the 6 weeks prior to visit 1 * patients with known hypersensitivity to ipratropium bromide, lactose or any other components of the inhalation capsule delivery system * patients with known sensitivity to inhaled β-agonists * patient using oral corticosteroid medication at unstable doses (i.e., less than 6 weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisolone per day or 20 mg every other day * pregnant or nursing women or women of childbearing potential not using medically approved means of contraception
adjunct phentermine + topiramate after bariatric surgery in 12-24 year olds

Conditions: Obesity, Morbid; Bariatric Surgery; Adolescent; Young Adult; Drug Therapy

Summary: the goal of this pilot study is to establish the feasibility and initial efficacy of the combination of phentermine and topiramate for adolescents and young adults who require additional risk reduction after bariatric surgery. this study will use a randomized, placebo-controlled, double-blinded design to evaluate an adjunctive 12-week intervention of phentermine + topiramate + standard of care vs. placebos + standard of care 6 months after bariatric surgery, among 12 to 24 year olds who don't achieve expected weight loss or who remain severely obese (n=10 total).


Eligibility criteria:
inclusion criteria: * status post sleeve gastrectomy or roux-en-y gastric bypass * at 6 months after bariatric surgery, has not achieved \>= 26% decrease in weight from preoperative weight (within 1 week of surgery) or remains severely obese (\>=120% of 95th%ile or bmi \>=35kg/m2 for 12-17yo; bmi \>=35kg/m2 for 18-24yo) exclusion criteria: * absolute contraindication to phentermine or topiramate (i.e. phentermine: history of coronary artery disease, stroke, arrhythmia, congestive heart failure, uncontrolled hypertension), hypersensitivity to sympathomimetic amines, current or recent (within 14 days) use of monoamine oxidase inhibitors, glaucoma, or hyperthyroidism; topiramate: hypersensitivity to topiramate, history of nephrolithiasis) * concomitant use of phenytoin, carbamazepine, or carbonic anhydrase inhibitors (e.g. zonisamide, acetazolamide, or dichlorphenamide) * use of anti-obesity medication within 6 months of screening * initiation of a new medication associated with weight loss or gain within 30 days of screening * type 2 diabetes mellitus * hypothalamic obesity * unmanaged (e.g. without medications and/or psychotherapy) clinically significant (determined by a mental health professional using diagnostic instruments and/or clinical interview) depression or anxiety * history of any suicidal behavior within 30 days of screening or any suicidal ideation with either some intent to act or with intent and a specific plan within 30 days of screening * history of schizophrenia * severe hepatic impairment (alt \>10x upper limit of normal or known synthetic liver dysfunction) * moderate or severe renal impairment (gfr \<30ml/min/1.73m2) * dosage change to hypertension, dyslipidemia, depression, or anxiety medication \<4 weeks prior to study enrollment * contraception started \<7 days prior to study enrollment * current pregnancy/plans to become pregnant within 16 weeks from study drug start date * females without a long acting reversible contraceptive (larc) who do not commit to using 2 forms of birth control

Keywords: pilot feasibility initial efficacy randomized controlled trial
extensive mesenteric excision (eme) versus local mesenteric excision (lme) for crohn's disease

Conditions: Postoperative Disease Recurrence; Crohns Disease

Summary: crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric resection group and local mesenteric resection group.

randomization was performed intraoperatively once the surgeon had determined that there were no other sites of disease and that either type of anastomosis could be performed safely. computer generated randomization was carried out within strata using randomized permuted blocks to ensure balance of the groups. all surgery was performed by a single group of surgeons experienced in the surgical treatment of crohn's disease. surgery was performed open or laparoscopically depending on patient factors and surgeon preference. the resection was performed grossly normal resection margins, with side-to-side anastomosis. the presence of mesenteric marginal thickening with confirmation by naked eye assessment of the mucosal aspect of the bowel were used to establish the limits of the disease.

Eligibility criteria:
inclusion criteria: * crohn's disease limited to the distal ileum and/or right colon exclusion criteria: * concomitant anastomosis/strictureplasty at another site of the gastrointestinal tract, and required a temporary fecal diversion