Kornimate/medical-research-clean huggingface dataset:
peers for promoting adolescent transplant health

Conditions: Behavior and Behavior Mechanisms

Summary: adolescents with solid organ transplants have poorer outcomes than adults, and do not respond as well to post-rejection treatment. in addition to well-recognized declines in individual health-related quality of life, premature graft loss creates considerable health and economic burdens. high nonadherence rates among adolescents are believed to contribute majorly to rejection, premature allograft dysfunction and failure. studies suggest that a telephone-based peer mentoring approach, with texting and e-communication, is a promising, practical means to promote medication adherence in adolescent solid organ transplant recipients. the study's main objectives are 1) to determine the efficacy of peer mentoring to improve medication adherence and health-related quality of life vs. usual care in adolescents and young adults with solid organ transplants, and 2) to determine the mechanisms through which peer mentoring impacts medication adherence and health-related quality of life.

the investigators will conduct a single-center phase ii randomized clinical trial in which adolescents ages 14-23 and greater 3 months post solid organ transplant will receive either a peer mentor or usual care. the investigators will assess changes in quality of life from baseline to one year post-study entry. the investigators will also examine adherence changes over the same time frame using pharmacy refill data and a questionnaire. peer mentors will provide social support and promote subject self-efficacy primarily via e-communication. changes in social support and self-efficacy will be measured over a one-year period.

Eligibility criteria:
inclusion criteria: * males or females age 14 to 23 years * greater than one year post kidney, heart or liver transplant * able to speak and read in english * willing and able to provide informed consent or assent * parental guardian permission (informed consent) if appropriate exclusion criteria: * unwilling to participate * unable to speak or read in english * unable to provide informed assent or consent * estimated glomerular filtration rate (egfr) less than 20 ml/min/1.73m\^2 * on dialysis * less than three months post transplant * post-transplant lymphoproliferative disease

Keywords: kidney renal transplant transplantation adolescent pediatric mentor mentoring medication adherence immunosuppressant heart liver
chronic periodontitis microbiota in type 2 diabetes mellitus patients

Conditions: Chronic Periodontitis; Type 2 Diabetes Mellitus

Summary: this study is a retrospective comparative evaluation of six main periodontal pathogens and total bacterial load in chronic periodontitis patients affected or not by type 2 diabetes mellitus by polymerase chain reaction analysis.

the aim of this study was to compare prevalence and bacterial load of six main periodontal pathogens among chronic periodontitis patients with and without type 2 diabetes mellitus. porphyromonas gingivalis and aggregatibacter actinomycetemcomitans genotypes were also investigated. the recruitment for the study sample was performed analysing the medical records of adult patients with chronic periodontitis visited between 2010 and 2016. eligible patients were subdivided in two balanced groups on the basis of the presence or absence of type 2 diabetes mellitus at the time of the microbiological test. for each subject, the following data have been collected: age, gender, smoking habits, type of metabolic control of diabetes, duration of diabetes, number of missing teeth. for each subject, four periodontal sites were studied. probing pocket depth, sites with bleeding on probing, sites with suppuration and microbiological data were evaluated. an individual matching on the basis of severity and extension of periodontitis was performed by pairing a diabetic patient with another non-diabetic one with the same degree of severity and extension of the periodontal disease. microbiological data of subgingival biofilm were analysed and compared for the examined pathogens: aggregatibacter actinomycetemcomitans, porphyromonas gingivalis, prevotella intermedia, treponema denticola, fusobacterium nucleatum, tannerella forsythia. differences in genotypes of porphyromonas gingivalis and aggregatibacter actinomycetemcomitans among diabetic and non-diabetic patients were also evaluated.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic periodontitis * diagnosis of type 2 diabetes mellitus (only in the test group) * the presence of at least 12 teeth (except for the third molar) * belonging to caucasian ethnic group * age greater than 18 years. exclusion criteria: * pregnant or lactating * history of systemic antibiotics within 3 months prior to the microbiological testing or anti-inflammatory therapy in the month before the visit * if they were suffering from any other systemic disease except diabetes mellitus (arthritis, ulcerative colitis, crohn's disease, osteoporosis or osteopenia, hiv infection, hematologic diseases, neoplastic diseases, cardiovascular diseases or pathologies that could potentially interfere with the periodontitis and/or with diabetes) * mental disorders * if they had received periodontal treatment in the 6 months before the microbiological test.

Keywords: subgingival analysis real-time pcr comparative study chronic periodontitis type 2 diabetes mellitus
a study of plb1001 in non-small cell lung cancer with c-met dysregulation(kunpeng)

Conditions: Non-small Cell Lung Cancer

Summary: this is a phase ii, open-label, multicenter and multi-cohorts study of plb1001 administered orally twice daily to locally advanced/metastatic nsclc patients with c-met dysregulation.

plb1001 will be administrated 200mg twice daily. the treatment will be discontinued for the patients who experience disease progression, death, adverse event (ae) leading to discontinuation or withdrawal of consent. a cycle of study treatment will be defined as 28 days of continuous dosing. the study includes 4 cohorts.

Eligibility criteria:
inclusion criteria: * signed informed consent form * age≥18 years * histologically or cytologically confirmed advanced non-small cell lung cancer * must have evidence of c-met dysregulation from the results of molecular pre-screening evaluations * at least one measurable lesion as per recist v1.1 * patients must have recovered from all toxicities related to prior anticancer therapies to grade ≤ 1 * ecog performance status of 0-1. exclusion criteria: * symptomatic central nervous system (cns) metastases that are neurologically unstable or requiring increasing doses of steroids to control, and patients with any cns deficits. * clinically significant, uncontrolled heart diseases unstable angina history of documented congestive heart failure (new york heart association functional classification \> ii) uncontrolled hypertension defined by a systolic blood pressure (sbp) ≥ 160 mm hg and/or diastolic blood pressure (dbp) ≥ 100 mm hg arrhythmias * adverse events from prior anti-cancer therapy that have not resolved to grade ≤ 1, except for alopecia * major surgery within 4 weeks prior to starting plb1001 * previous anti-cancer and investigational agents within 2 weeks before first dose of plb1001. if previous treatment is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of plb1001 * pregnant or nursing women * involved in other clinical trials \< 2 weeks prior to day. if previous treatment of clinical trial is a monoclonal antibody, then the treatment must be discontinued at least 4 weeks before first dose of plb1001.
predicting the severity of post-cesarean wound infections using serum procalcitonin levels

Conditions: Wound Infection; Cesarean Wound Disruption

Summary: the serum procalcitonin levels are important during infections and sepsis. the investigators aimed to assess its predictive value in terms of post-cesarean wound infection.

the serum procalcitonin levels are important during infections and sepsis. recent studies showed that serum procalcitonin levels are more sensitive than serum crp levels.the investigators aimed to assess its predictive value in terms of post-cesarean wound infection. the serum procalcitonin levels are aimed to measure in participants who had cesarean section and developed surgical site infection. the investigators aimed to compare the serum procalcitonin levels between the patients who need secondary suture and the patients who did not need secondary suture.

Eligibility criteria:
inclusion criteria: * who developed surgical site infection after their cesarean sections. * 18-40 years old exclusion criteria: * history of chorioamnionitis and premature rupture of membranes * urinary tract infections * any infectious condition other than surgical site infection
effect of md1003 in spinal progressive multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to demonstrate the superiority of md1003 over placebo in the disability of patients suffering from progressive multiple sclerosis and especially those with gait impairment.


Eligibility criteria:
inclusion criteria: * diagnosis criteria of secondary or primary progressive ms with clinical evidence of spastic paraparesis fulfilling revised mcdonald criteria (2010) and lublin criteria (1996) * progression of the edss during the past two years of at least 1 point if edss from 4.5 to 5.5 and at least 0.5 point if edss from 6 to 7 * edss score from 4.5 to 7 (measured away from a relapse and confirmed at 6 months) * informed consent prior to any study procedure * patient aged 18-75 years exclusion criteria: * any general chronic handicapping disease other than ms * intensive physical therapy program within the 3 months prior to inclusion * impossibility to perform the tw25 test * new treatment introduced less than 3 months prior to inclusion or less than 1 month for fampridine * pregnancy or woman with childbearing potential without contraception * evidence of inflammatory activity of the disease defined as "clinical evidence of a relapse during the year before inclusion or evidence of new gadolinium-enhanced lesions on a brain mri performed the year before inclusion."

Keywords: multiple sclerosis ms edss
validity of the kinematic classification of gait in diplegic children with cerebral palsy (cp)

Conditions: Cerebral Palsy; Diplegia, Spastic

Summary: in recent years ferrari et al. proposed a new classification of gait in diplegic children with spastic diplegia that describes four different patterns of gait by analyzing the strategies that each children adopts to need his/her needs to walk. the investigators believe that this classification provides the clinician with clinically meaningful information in terms of coping strategies adopted to maximize the ability to walk. the aim of this study is to determine the criterion validity of the new classification of the pattern of gait in children with spastic diplegia by correlating pattern of diplegic gait with the score of the functional performance measure.


Eligibility criteria:
inclusion criteria: * diplegia and cp; exclusion criteria: * severe mental retardation attested by the diagnostic and statistical manual of mental disorders iv * pharmaco-resistant epilepsy * behavioural disorders

Keywords: cerebral palsy diplegia gait classification
quality of life in patients with hemorrhagic telangiectasia

Conditions: Hereditary Hemorrhagic Telangiectasia

Summary: hereditary hemorrhagic telangiectasia (hht), also known as osler's disease, is a genetic disorder that leads to abnormal blood vessel formations. it primarily affects blood vessels in the skin, mucous membranes, and internal organs. the disease can be clinically diagnosed using the curaçao criteria (1. positive family history of hht, 2. recurrent and spontaneous epistaxis, 3. multiple typical telangiectasias, 4. organ involvement with vascular malformations, especially in the liver, lungs, gastrointestinal tract, or brain); if a patient meets at least 3 criteria, the diagnosis of hht can be established. patients with hht often have telangiectasias on their faces. additionally, many patients suffer from anemia, which can result in a pale and potentially tired appearance. patients with hht may be less satisfied with their appearance due to the aesthetic changes in their faces and may also experience psychosocial impairment. to further investigate this, various validated questionnaires (face-q©, promis-profile-29+2, eq5d), as well as routinely collected clinical data (e.g., laboratory values including hemoglobin levels, curaçao criteria, smoking status, alcohol consumption, and the epistaxis severity score (ess)) will be used.


Eligibility criteria:
inclusion criteria: * knowledge of german language * age above 17 years * capable of giving consent * diagnosis of hht (curaçao criteria or genetic testing) exclusion criteria: -individuals not meeting the inclusion criteria.
a study to evaluate the durability of response of ctp-543 in adult patients with moderate to severe alopecia areata

Conditions: Alopecia Areata

Summary: this study is designed to evaluate the regrowth of hair with ctp-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.


Eligibility criteria:
inclusion criteria: * definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months and not exceeding 10 years at the time of screening. total disease duration greater than 10 years is permitted. * at least 50% scalp hair loss, as defined by a severity of alopecia tool (salt) score ≥50, at screening and baseline. * willing to comply with the study visits and requirements of the study protocol. exclusion criteria: * treatment with other medications or agents within 1 month of baseline or during the study that may affect hair regrowth or immune response. * active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the salt assessment, or untreated actinic keratosis anywhere on the body at screening and/or baseline. * treatment with systemic immunosuppressive medications within 3 months of screening or during the study, or biologics within 6 months of screening or during the study. * females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug. * clinically significant medical condition, psychiatric disease, or social condition, as determined by the investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.

Keywords: ctp-543
modification of the quality of life based on objective geriatric tests

Conditions: Cancer; Elderly Patients

Summary: the analysis of this study will achieve an improvement in the management of patients over 70 years with adaptation of chemotherapy regimens after analysis of the subject and its psychosocial environment. the analysis of socio-economic impacts will implement actions to optimize the care of the elderly while emphasizing the value of management / cost of care.

quality of life is defined as "an individual's perception of his place in life, in the context of culture and value system in which he lives, in relation to its goals, expectations, standards and concerns "(who 1993). this concept refers to multiple dimensions, both objective and subjective: * the physical condition of the person, his functional abilities; * his somatic sensations; * his psychological health; * his social status, relational environment. this concept focuses on perception's basics. quality of life is a criteria supposed to be objective even though it is subject to subjective interpretation at the highest point. indeed, if the quality of life varies depending on the discretion of each person, it also changes over time: it refers to a situation at a given moment and not to a stable state. therefore in this study, it seemed appropriate to show the concept of "quality of life objective" which is linked to objective data measures recognized criteria for evaluating the elderly. these criteria are repeatable, validated and not dependent operator. this process completely matches with the actions promoted by the 2009-2013 cancer plan (measures 23 and 26) on the basis of an improvement of: * the quality of consideration of the psychosocial dimension (customization accompaniment, living environment, social, involvement, ..) * the quality of the integration of physical and psychological dangers inherent to this weakness situation induced by cancer.

Eligibility criteria:
inclusion criteria: * patient over 70 years, * patient with a solid malignant tumor, * patients for whom a first line chemotherapy is theoretically indicated * patient chemotherapy naive, * performance index (ps) \<4 exclusion criteria: * patient not understanding or do not speak french, * patients with any severe psychopathological disorder preventing the completion of the questionnaire or invalidating a priori measures of the questionnaire
a randomized trial of frovatriptan for the intermittent prevention of menstrual migraine

Conditions: Menstrually Associated Migraine

Summary: the primary objective of this study was to determine whether frovatriptan was effective in the prevention of menstrually associated migraine (mam) headaches when compared to placebo. secondary objectives included determining the effectiveness of frovatriptan in reducing the incidence, severity and duration of mam headaches and associated symptoms, to evaluate the safety and tolerability of the two frovatriptan dosing regimens and to compare the effectiveness of these regimens in the prevention of mam headaches. in this cross-over study, patients treated each of 3 perimenstrual periods (pmps) with placebo, frovatriptan 2.5 mg daily (qd) and 2.5 mg twice daily (bid) for 6 days, starting 2 days before the anticipated onset of a mam headache. a statistically significant reduction in the incidence of mam headache (p\<0.0001) was observed with both dosing regimens of frovatriptan when compared to placebo. additionally, the frovatriptan bid regimen was superior to the frovatriptan qd regimen in the prevention of mam headache (p\<0.001). significant reductions in mam headache severity and duration, the incidence of associated symptoms and characteristics, and the use of rescue medication were observed when the pmp was treated with frovatriptan, compared to placebo. both dose regimens of frovatriptan were equally well tolerated and no cardiovascular or other safety and tolerability concerns arose with repeated administration of frovatriptan over a 6 day period.


Eligibility criteria:
inclusion criteria: * females aged 18 years and over * 12 month or more documented history of menstrual migraine headache, according to international headache society classification * an average frequency of mam attacks in at lease 3 out of 4 menstrual cycles * regular predictable menstrual periods * able to accurately predict the onset of mam headaches occurring between day -2 and day +4 of menses * able and willing to sign informed consent to comply with study procedures, including completion of diary cards exclusion criteria: * more than three migraine attacks per month that were not mam attacks * coronary artery disease including coronary vasospasm * significant cerebrovascular disease including basilar or hemiplegic migraine * uncontrolled hypertension * severe hepatic or renal insufficiency * more than 15 headache days per month * any other condition or serious illness which would interfere with optimal participation in the study * history of clinically relevant allergy, including that to frovatriptan or other triptans * pregnant or breast feeding or intending to become pregnant or to breast-feed during study period * participated in other frovatriptan menstrual migraine prevention studies * use of another investigation drug within 30 days or 5 half-lives (whichever is longer) before the screening visit
investigational drug in patients with hypercholesterolemia or in patients with sitosterolemia (0653-026)(completed)

Conditions: Hypercholesterolemia, Familial; Lipid Metabolism, Inborn Errors

Summary: the purpose of this study is to provide an investigational drug to patients with a specific type of hypercholesterolemia (high cholesterol) or sitosterolemia (unusually high absorption of non-cholesterol sterols) in a treatment use setting.


Eligibility criteria:
inclusion criteria: * homozygous familial hypercholesterolemia or sitosterolemia exclusion criteria: * patient has a condition which, in the opinion of the investigator, might pose a risk to the patient, interfere with participation in the study, or does not meet the additional criteria as required by the study
preemptive analgesia with intravenous paracetamol for post-cesarean section pain control

Conditions: Cesarean Section; Dehiscence

Summary: the investigators designed a prospective randomized study to investigate the efficacy of intravenous (iv) preemptive paracetamol on postoperative pain scores, patient satisfaction, total morfin consumption and the incidence of morfin-related side effects in patients undergoing cesarean section.


Eligibility criteria:
inclusion criteria: * patients between the ages of 20-40 years, * asa physical status 1-2 who underwent elective cesarean surgery during general anesthesia were included in the study exclusion criteria: * a history of allergy to any of the study medications (opiod, general anesthetic agents or paracetamol), * history of opioid or paracetamol use, * hepatic or renal failure, * any psychological disorders, * complications during cesarean section and unable to use pcia device were excluded from the study.
serological response to porcine circovirus type 1 (pcv-1) and pcv-1 dna in stools of infants following administration of rotarix™

Conditions: Rotavirus Infection; Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants

Summary: this study aims to test the clinical samples (stool and serum) previously collected during clinical development of hrv vaccine, to identify if there is any evidence of pcv-1 replication and/or immune response to the pcv-1 in vaccinated infants.

serum and stool samples collected from 4 clinical trials previously conducted for hrv vaccine (rotarix™) are used in this study.

Eligibility criteria:
inclusion criteria: * subjects enrolled previously in randomized, double-blind and placebo-controlled studies 444563/022 (nct00263666), 444563/033 (nct00757770), 103477 (nct00169455), and 104480 (nct00137930); * infants aged 6 to 12 weeks at dose 1 vaccinated with either hrv vaccine or placebo; * infants for whom sufficient residual volume of the stool samples at predetermined time points is available; * infants for whom sufficient residual volume of the pre and post vaccination blood samples is available. exclusion criteria: - not applicable

Keywords: laboratory evaluations infants porcine circovirus type 1 (pcv-1) serologic response human rotavirus (hrv) vaccine