Kornimate/medical-research-clean huggingface dataset:
evaluating the effectiveness of the lower-clear-plate-based intermaxillary traction

Conditions: Class III Malocclusion

Summary: patients at the orthodontic department of the university of damascus dental school will be examined, and subjects who meet the inclusion criteria will be included. then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure the selection criteria are accurately matched. this study compares two groups of patients with mild to moderate skeletal class iii in the late mixed occlusion stage. experimental group: the patients in this group will be treated with lower-clear-plate based intermaxillary traction control group: the patients in this group will be treated using the removable mandibular retractor (rmr).

there are different methods of correcting class iii deformity in orthodontics. lower-clear-plate-based intermaxillary traction has been shown to be an effective method of managing these cases. this treatment modality has not been compared with the well-known appliance (the removable mandibular retractor; rmr). therefore, the current study compares both groups of growing children with class iii malocclusion. the study design is a randomized controlled trial.

Eligibility criteria:
inclusion criteria: * class iii dental malocclusion at the molar relationship, according to angle's classification * presence of an anterior crossbite on two or more teeth or an edge-to-edge relationship at the anterior teeth * mild to moderate skeletal class iii in the late mixed occlusion stage (9-13 years old) or the beginning of permanent occlusion (not exceeding 13 years old; anb = +1 to -4 degrees) * normal or horizontal growth pattern (mm ≤ 35; sn.manp ≤ 40) * normal or labial inclination of the lower incisors (impa = 85 to 100 degrees) * patient's willingness to cooperate during the orthodontic treatment period exclusion criteria: * class iii skeletal relationship caused solely by the maxillary recession (sna \< 78 and a normal snb angle) * an indication of rme * presence of clear asymmetry (deviation of mandibular midline more than 2 mm from facial midline) * presence of any craniofacial syndromes (such as cleft lip or palate) * systemic diseases; previous facial trauma; and previous orthodontic treatment.
post-marketing surveillance (pms) protocol of rekovelle pre-filled pen (follitropin delta)

Conditions: Infertility, Female

Summary: this post-marketing surveillance study was conducted in accordance with the regulations for re-examination of domestic new drugs (standard for re-examination of new drugs: ministry of food and drug safety \[mfds\]: notification no. 2017-95, 21 nov, 2017). it was important to monitor the pattern of drug use in general practice for a long term after marketing authorization, and to investigate and identify potential new adverse events (aes) and their onset status that were not observed during the drug development phases and any potential factors that affect safety and effectiveness of the new drug.


Eligibility criteria:
inclusion criteria: * participants who were prescribed with rekovelle (follitropin delta) for the first time according to the approved administration method and dose * participants who have consented to personal information use exclusion criteria: * participants who are prohibited from use according to the special warnings and precautions for use of rekovelle (follitropin delta)

Keywords: follitropin delta rekovelle
safety and efficacy of an anticholinergic agent for treatment of primary axillary hyperhidrosis

Conditions: Hyperhidrosis

Summary: this phase 2 study is designed to evaluate multiple doses of an anticholinergic-containing medication and identify the dose or doses that may effectively reduce axillary sweating in hyperhidrotic subjects. the anticholinergic agent being studied is designated wl8713.


Eligibility criteria:
inclusion criteria: * healthy volunteers with primary axillary hyperhidrosis * poor quality of life rating on the hyperhidrosis disease severity scale (score of 3 or 4) * has a baseline gravimetric measurement of spontaneous resting sweat production of ≥100 mg/10 min at room at room temperature in at least one axilla * meets at least two of the following criteria (self-reported): * sweating is bilateral and symmetrical * excessive sweating impairs daily activities * subject experiences at least one sweating episode per week * excessive sweating onset was earlier than age 25 years * has a positive family history for excessive sweating * cessation of sweating during sleep
mental healthcare in older adults with schizophrenia

Conditions: Schizophrenia; Chronic Psychiatric Disorder

Summary: as in the general population, there is a gradual and steady increase in life expectancy of patients with schizophrenia. but this increase is at a smaller scale, with a rate of premature death that is still 2 to 3 times higher than that found in the general population. this excessive early mortality is explained by an overrepresentation of suicide deaths, but also a higher prevalence of somatic diseases, mainly cardiovascular. but today there are only very few epidemiological data on the mortality of patients with schizophrenia, including those aged over 60 years. what are the sociodemographic and clinical characteristics (psychiatric and somatic) of these schizophrenic elderly patients? do they benefit from a somatic follow-up adequate and systematic? what are their levels of social independence and of quality of life? the answers these questions and the description of the offer of geriatric care and of psychiatric care currently provided by different sectors of psychiatry in france is an indispensable prerequisite for any project to improve the quality of life, state of health and mortality of older patients with schizophrenia.

evaluate prospectively over 5 years, the rates and causes of mortality in a cohort of schizophrenic patients older than 60 years, followed by adult psychiatry sectors, compared to those patients matched for sex and age and monitored by the same sectors for a chronic psychiatric disorder other than schizophrenia

Eligibility criteria:
inclusion criteria: * men or women aged than 60 years with a diagnosis of schizophrenia, according to the dsm-iv criteria * men or women aged than 60 years with chronic psychiatric disorder other than schizophrenia * patients consenting to participate to the study * patients enrolled in the national healthcare insurance program exclusion criteria: -disease affecting the central nervous system
supporting together exercise and play and improving nutrition

Conditions: Obesity

Summary: the purpose of this study is to design, pilot, and tweak a series of peer-led group nutrition sessions for primary care patients aged 6 -12 years who are overweight or obese and who want to eat healthier and be more active.

in addition to the group nutrition sessions, the investigators will give a fitbit to each of a parent and child dyad, which will be used to track and motivate their activity. the investigators hypothesize an improvement pre-post in children's physical activity levels, self-efficacy and intentions for physical activity, self-reported consumption of fruits, vegetables, and child quality of life, and a decrease in consumption of sugar-sweetened beverages and fast and snack-food, and television (tv)/ videos screen time

Eligibility criteria:
inclusion criteria: * patients whose primary medical home is the pediatric primary care center (primarily medicaid or self-pay) * bmi is greater than 85th%ile for age and sex * english speaking * have access to a computer/internet or a smart phone (for uploading fitbit data) exclusion criteria: * have been seen in a weight management clinic within the last 2 years * prescribed an atypical antipsychotic * non-ambulatory
intranasal dexmedetomidine vs intranasal midazolam as anxiolysis prior to pediatric laceration repair

Conditions: Laceration; Anxiety

Summary: the objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.


Eligibility criteria:
inclusion criteria: * presenting to children's hospital of pittsburgh of university of pittsburgh medical center * laceration \<5 cm in total length * require simple suture laceration repair exclusion criteria: * allergies/intolerance/contraindication to the study drugs * lacerations requiring complex (multilayer) repair or total laceration length\>5cm

Keywords: dexmedetomidine midazolam
stem cell transplantation for hematological malignancies

Conditions: Leukemia, Lymphocytic, Acute; AML; MDS

Summary: this protocol using busulfan, cyclophosphamide and melphalan has been designed as conditioning therapy for patients receiving stem cell transplantation for acute leukemia or myelodysplastic syndrome (mds). the hypothesis is that this new regimen will be well tolerated and will cure the patient.

subjects will be admitted to the bone marrow transplant unit and put in isolation to reduce exposure to infectious agents. prior to transplantation, they will receive busulfan via the central venous line, four times a day for four days, cyclophosphamide via the central venous line once a day for two days, and melphalan via the central venous line for one day. busulfan, cyclophosphamide, and melphalan are given to destroy the subject's cancer. as well, these drugs will destroy their immune system to help ensure the new stem cells take and grow after transplantation. on the day of transplantation, umbilical cord blood from the donor will be transfused via venous line. these new cells will replace the subject's bone marrow. after transplantation, the subjects will receive cyclosporin a and either mmf or mtx isolation will be continued until adequate numbers of cells are present in the blood to fight infection. subjects will be discharged from the hospital when medically ready. they will be expected to return for follow-up to the blood and marrow transplant clinic at specific dates as determined by physicians.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of acute lymphocytic leukemia (all), acute myeloid leukemia (aml) or myelodysplastic syndrome (mds) and currently be in complete remission. * patients must be either: * - \<18 years of age who are at least 6 months after initial hematopoietic cell transplant (hct), * - 19-35 years of age and at least 18 months after initial hct, or * - \<35 years of age and have received sufficient radiation treatment to be ineligible for total body irradiation (tbi) containing preparative therapy * adequate major organ function including: * - cardiac: ejection fraction \> or = 45% * - renal: creatinine clearance \> or = 40 ml/min * - hepatic: no clinical evidence of hepatic failure (e.g. coagulopathy, ascites) * - karnofsky performance status \> or = 70% or lansky score \> or = 50% * women of child bearing age must be using adequate birth control and have a negative pregnancy test. * written informed consent. exclusion criteria: * eligible for tbi containing preparative regimen. * active uncontrolled infection within one week of hct. * pregnant or lactating females.

Keywords: stem cell transplant retransplant hematological malignancies
atg plus low-dose pt-cy for gvhd prevention

Conditions: Hematologic Malignancy

Summary: during the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-hct) has been made possible through the t cell-replete (tcr) regimens including t cell regulation with anti-thymocyte globulin (atg)/granulocyte colony-stimulating factor (gcsf) and post-transplant cyclophosphamide (ptcy). to achieve decreased non-relapse mortality (nrm) and improved long-term outcomes in haploidentical transplant, the joint use of atg and ptcy might effectively reduce graft versus host disease (gvhd) and mortality associated with severe forms of gvhd. recently, investigators established a regimen using low-dose ptcy in conjunction with standard-dose atg in order to lower the risk of gvhd without compromising engraftment and disease relapse.


Eligibility criteria:
inclusion criteria: 1. patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation; 2. male or female , aged 12-55 years; 3. haploidentical donor transplantation; 4. ecog score ≤3; the basic organ function tests met the following standards; 1) cardiac ejection index \>55% 2) creatinine ≤1.5 times the highest normal value (uln) exclusion criteria: 1. severe brain, heart, kidney or liver dysfunction; 2. refractory malignant state; 3. patients with other malignant tumors requiring treatment; 4. clinically uncontrolled severe active infection; 5. the expected survival time was less than 3 months. 6. a history of severe anaphylaxis. 7. pregnant or lactating women; 8. any condition considered by the investigators to be unsuitable for enrollment.
acute limb ischaemia (ali) management with 'indigo' mechanical aspiration system

Conditions: Lower Limb Ischemia

Summary: international multi-centre registry recording comprehensive data on the use of 'indigo' mechanical thrombectomy system by penumbra inc for the removal of acute clot causing acute or critical limb ischaemia.

a detailed registry has been designed and approved to be used world wide in vascular and trauma centres, already providing endovascular service for the management of critical limb ischaemia (cli). recent campaigns have shown little is done to improve flow to the lower limbs (legs) of patients to avoid amputation rates. during this time many devises have been used and available on the market. the 'indigo' system by penumbra was originally designed from the acute stroke system "ace". similar principles were applied in designing the 'indigo' system. this is currently being used in many centres to manage acute clot causing lower limb ischaemia, however no official registry or international clinical trial has been done to show its significance in managing this disease. the investigator groups, have created this to come up with enough data to evaluate the indigo system in the management of (ali) and offer tips and tricks to other clinicians. the aim is for a single arm, multicenter, retrospective analysis of patients in whom (ali) was performed with the penumbra/indigo system (study device), and gather greater data and information than the prism trial in 2013-2014 which obtained only 79 patients.

Eligibility criteria:
inclusion criteria: * acute lower limb ischaemia with acute soft clot. exclusion criteria: * calcified plaques/ chronic disease causing critical limb ischaemia
purdue university parenting program attrition

Conditions: Child Abuse

Summary: the purpose of this study is to examine the efficacy of techniques to enhance participation in parenting programs.

this project addresses the problem of involving parents in interventions that promote parenting effectiveness and child coping-competence in preschoolers as a means of reducing risk of child maltreatment (and related adverse developmental outcomes). purdue university will examine the impact of partnership (organizational involvement in recruitment and retention), cash incentives, and a motivational goal setting component on participation and engagement in the parenting our children to excellence program, a group intervention for parents and caregivers of preschool children.

Eligibility criteria:
inclusion criteria: * parents with children 3-5 years old who attend centers in which interventions are offered exclusion criteria: * see above. no other exclusion criteria will be used.

Keywords: parenting motivation child maltreatment program attrition
effect of paroxetine on smokers' cardiovascular response to stress - 1

Conditions: Tobacco Use Disorder

Summary: smokers report that they often smoke cigarettes during stressful times. the combined effect of smoking and exposure to stress leads to exaggerated increases in blood pressure, heart rate and other measures of stress response. this combination may result in greater cardiovascular harm than either smoking or stress alone. the purpose of this study is to determine the effects of paroxetine on the response to stress after smoking.

smokers report that they often smoke cigarettes during stressful times. smoking and stress produce similar physiological responses such as increases in heart rate, blood pressure, and adrenaline levels. the combination of smoking and stress results in greater increases in these physiological responses compared to smoking or stress alone. such increases are thought to be harmful to cardiovascular health. additionally, smokers with exaggerated responses to stress may be more likely to relapse following a smoking cessation attempt. the purpose of this study is to assess the effects of paroxetine, a selective serotonin reuptake inhibitor (ssri), on the cardiovascular response to stress after smoking. participants in this double-blind, placebo-controlled study will receive 1 month of paroxetine and 1 month of placebo with the order of which is taken during the first month randomly assigned. paroxetine will be administered at a daily dose of 10 mg for the first week and increased to a daily dose of 20 mg for the remainder of the study. after one month of medication, participants will abstain from smoking for one night and then undergo mental stress testing the following day. immediately prior to the mental stress testing, participants will smoke a cigarette. mental stressors will include speaking and math tasks. physiological measures of stress (e.g., blood pressure, heart rate, and plasma catecholamine concentrations) and subjective measures of stress will be evaluated. following the second month of medication, participants will again undergo the procedure for mental stress testing and evaluation.

Eligibility criteria:
inclusion criteria: * smokes an average of at least 10 cigarettes per day during the year prior to enrollment exclusion criteria: * interested in quitting smoking within the 3 months following enrollment * current unstable medical condition * substance abuse within the year prior to enrollment * current use of any medications (e.g., psychoactive medications, antihypertensives) that, in the opinion of the investigators, might interfere with study measures or that would be expected to interact with paroxetine (e.g., cyp2d6 substrates) * smoking cessation therapy within the 3 months prior to enrollment * regular use of any form of tobacco other than cigarettes * significant psychiatric disorders as assessed by the prime-md and verified by a clinician * history of hypersensitivity to any selective serotonin reuptake inhibitor * pregnancy or breastfeeding

Keywords: smoking
safety and efficacy of exenatide in patients with type 2 diabetes using a thiazolidinedione or a thiazolidinedione and metformin

Conditions: Type 2 Diabetes Mellitus

Summary: this study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (tzd) and a tzd plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * if treated with a thiazolidinedione (tzd) alone, the tzd dose must have been stable for at least 120 days * the dose of tzd must be: rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day) * the metformin dose has been stable for at least 90 days * have suboptimal glycemic control as evidenced by an hba1c between 7.1% and 10.0%, inclusive. * have a body mass index (bmi): 25 kg/m2 \< bmi \< 45 kg/m2. exclusion criteria: * have participated in this study previously or any other study using exenatide (ac2993/ly2148568) or glucagon-like peptide-1 (glp-1) analogs, or have been previously treated with exenatide or glp-1 analogs * have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. this criterion includes drugs that have not received regulatory approval for any indication at the time of study entry. * have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening * used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening. * are currently treated with any of the following excluded medications: * sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening * alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening * dipeptidyl peptidase-4 (dpp-4) inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening * pramlintide acetate injection within 3 months prior to screening * drugs that directly affect gastrointestinal motility, including, but not limited to: metoclopramide, cisapride, and chronic macrolide antibiotics * are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start

Keywords: diabetes exenatide metformin thiazolidinedione byetta amylin lilly
effects of an 8 component botanical supplement on mild and moderate alzheimer's patients

Conditions: Alzheimer Disease; Alzheimer Dementia

Summary: this placebo-controlled, double blind study evaluates the treatment effects of adding a multi-pathway botanical dietary supplement (rebuilder) to the standard treatment regimens of subjects diagnosed with mild or moderate stage alzheimer's disease. the objective of the study is to determine if mild and moderate ad patients exhibit improved or stabilized cognitive function when this supplement is added to maximum tolerated doses of their standard treatments.

currently, there is no treatment that can stop the progression of alzheimer's disease. the investigators in this study have used transgenic drosophila melanogaster models and machine learning to develop an eight component botanical mixture (geneaire™\* rebuilder™) that targets multiple genetic pathways involved in brain aging and dementia that are homologous between drosophila and humans. while beta-amyloid plaques and phosphorylated-tau tangles are diagnostic for ad, the cause(s) of their soluble precursors that kill neurons has not been determined. the majority of ad patients are diagnosed after 60 years of age. many studies point to aging related processes like inflammation, neural vascular damage, neural stress, altered cell metabolism, inefficient cellular autophagy, microglial dysfunction, mitochondrial dysfunction, and poor diet as potential causal factors in the decline of brain function over the decades that precede an actual ad diagnosis. ad is a multifaceted pathology involving many biochemical pathways and thus a multifaceted therapeutic approach may prove beneficial. the goal of this study was to test rebuilder on human cognitive function. during the 12-month pilot study, the subjects were evaluated quarterly on the mini mental state exam (mmse), alzheimer's disease cooperative study's activities of daily living (adcs-adl), and the clinical dementia rating sum of boxes (cdr-sb).

Eligibility criteria:
inclusion criteria: * diagnosed mild or moderate alzheimer's disease exclusion criteria: * history of heart disease * history of heart attack * history of cancer * history of stroke or transient ischemic attack