cyrilzakka/clinical-trials huggingface dataset:
DPBRN Hygienists Internet Quality Improvement in Tobacco Cessation (HiQuit)

Our overall goal is to advance science related to using the Internet in health services delivery, and specifically smoking cessation by targeting dental hygienists. Our proposed intervention is the first Internet-delivered intervention to target the dental microsystem for smoking cessation-providing access to hygienists and patients.

This study is designed to allow dental hygienists and dentists to provide additional tobacco cessation counseling with little additional marginal effort. This would be done using an Internet-based referral to external resources. This system, termed "ReferASmoker", will allow hygienists and dentists to refer patients to a patient education, self-management website, "Decide2Quit" and accompanying Quitline, while the patient is still in the dental office. We anticipate that hygienists will be the primary drivers of this intervention. Our intervention has several innovations designed to support the dental practice in their tobacco cessation activities and maximize patient cessation rates. We will randomize 80 community-based primary dental practices into a clinical trial.

Aim 1. To test hypothesis 1(H1)that the number of patients REFERRED to the self-management resource website will be larger in the intervention practices compared to control practices.

Aim 2. To test hypothesis 2 (H2) that the proportion of patients referred who GO to the patient self-management website will be larger in intervention practices compared to control practices

Aim 3. To test hypothesis 3 (H3) that the proportion of smokers who are referred who QUIT at six months will be larger among intervention compared to control because of the additional connectivity of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Community-based practices with internet access available in the office seeing an average of five or more smokers in a week.

Exclusion Criteria:

* Exclude practices that have ongoing computer-based smoking cessation programs for patients.
Enteral Nutrition Support in Children and Adolescents With Cancer

CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status of cancer patients, leading to nutritional support. The aim was to study enteral nutrition indications, as well as its compliance and the impact on nutritional status.

DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year followed during anticancer therapy were included from January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR) was indicated.


Eligibility Criteria:
Inclusion Criteria:

* Were chemotherapy, age above one year and malnutrition
* A z-score of weight for height (zW/H) \< -1.0 to -2.0 in children26 and ≥ 5th to \< 15th of body mass index (BMI) in adolescents 27 were considered as mild malnutrition
* A zW/H \< -2.0 in children and \< 5th of BMI in adolescents as severe, respectively.28 In adults, the World Health Organization (WHO)29 cut-off values were applied: \< 18.5 mild and \< 17 severe malnutrition.

Exclusion Criteria:

* Were corticosteroid or hormonal therapy
* Swallowing abnormalities
* Parenteral or tube feeding therapy
* Palliative care and presence of non cancer-related diseases.
To Investigate the Bone and Muscle Abnormalities in Patients With Chronic Kidney Disease With MRI

Patients with chronic kidney disease (CKD) have a higher risk of fractures than those without. The purpose of this study is to develop a non-invasive Magnetic resonance imaging (MRI) method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD.

Chronic Kidney Disease-Mineral and Bone Disorder (MBD） is a common complication of chronic kidney disease (CKD), which may lead to defective mineralization, altered bone morphology, and/or bone turnover. Animal research found that bone changes occur even in the early stage of CKD , and with CKD progression, the patient may show symptoms such as bone pain, joint pain, bone deformation, and even spontaneous fractures.

Despite significant advances in understanding bone disease in CKD, most clinical and biochemical targets used in clinical practice remain controversial, resulting in an undermanagement of bone fragility.Our ability to diagnose CKD-MBD and to initiate strategies that could prevent fractures remains limited by the lack of accurate and noninvasive diagnostic tools.

The purpose of this study is to develop a non-invasive method that can improve fracture risk prediction and provide early diagnosis for bone abnormalities in patients with CKD.

Eligibility Criteria:
Inclusion Criteria:

CKD patients aged 18-70 years with free movement

-

Exclusion Criteria:

1. The following diseases: rickets, osteomalacia, Paget's disease, acromegaly, scurvy (vitamin C deficiency), hyperthyroidism, history of malignant tumors, received radiotherapy and chemotherapy, fractures within 6 months, lumbar and calf trauma surgery, scoliosis, rheumatic immunity disease, anorexia nervosa, motor neuron disease
2. Treated with the following drugs within two years:

   A) Bisphosphonates: Alendronate , etidronate , Ibandronate, rithiadronate, and zoledronate B) Steroid hormones: estrogen replacement agents , isoflavone derivatives , estrogen, progesterone C) Oral glucocorticoids: prednisone , Prednisone D) Salmon calcitonin
3. MRI contraindications: Intra Uterine Device(iUD), pacemaker, cochlear implant, claustrophobia, etc -
Short, Simple, Exercise to Improve Circadian Dependent Postprandial Glycemic Responses

The goal of this clinical trial is to test whether one minute of stair stepping at a comfortable pace can reduce blood sugar after meals. The main objectives of the study are:

Compare continuously measured post-meal glucose after stair-stepping to control condition Compare continuously measured post-meal glucose after stair-stepping between meals Assess interaction between condition and meal to determine if the effect of stair-stepping on post-meal glucose depends on meal

Participants will be in the study for 10 days and will be asked to:

Wear a continuous glucose monitor over the course of the study Perform either one minute of comfortable pace stair stepping 15 min after each meal OR no exercise 1 hour after eating a meal on alternating days Perform a dietary recall every two days Perform no exercise within one hour after each meal on any day during the study Consume no calories within one hour after each meal during the study

After being informed about the study and potential risks, all participants giving written informed consent will undergo a screening to determine eligibility for study entry. At day 1, patients who meet the eligibility requirements will be randomly assigned to Arm 1(stair stepping day followed by no exercise day sequence) or Arm 2(no exercise day followed by stair stepping day sequence). At this time participants will also be familiarized with the continuous glucose (i.e., blood sugar) monitor they will wear for ten days, be instructed how to fill out a food log every day and determine a comfortable stair stepping pace. On day 10 participants will return to the lab for sensor removal and transmitter return.

Eligibility Criteria:
Inclusion Criteria:

* between 18 and 65 years
* able to climb and descend stairs
* access to stairs

Exclusion Criteria:

* glycemic medications that vary in dosage
* dosage from meal to meal or day to day (eg insulin titrated to meal size or carbohydrate content)
Validation of the REPS Prediction Tool

Neuromuscular blocking agents' (NMBA) use during surgery is associated with postoperative respiratory complications and increased risk of readmission to the hospital following ambulatory surgery. Residual neuromuscular block (rNMB) after surgery is difficult to identify. We have recently developed the REsidual neuromuscular block Prediction Score (REPS), that predicts the risk for postoperative rNMB. Our primary objective is now to assess the predictive ability of the REPS for respiratory complications within seven days following general anaesthesia. The secondary objective is to compare the predictive values of REPS and train-of-four (TOF)-ratio below 0.90 for respiratory complications.

Residual neuromuscular blockade occurs in about 20-60% of patients and depends on compound and dose of NMBA reversal agent used. While on the one hand, NMBAs optimize surgical conditions and facilitate mechanical ventilation in patients with ventilator asynchrony, on the other hand, these agents have been associated with respiratory complications and increased risk of readmission after ambulatory surgery. A consensus in regard to guidelines and thresholds to define the optimal strategy to optimize surgical conditions is yet to be achieved. We have shown that utilization of non-depolarizing muscle relaxants and their reversal agents can be improved by dedicated quality improvement techniques. We have also recently developed the REPS, a tool that predicts postoperative rNMB.

This is a retrospective, observational, cohort study based on on-file hospital data from Beth Israel Deaconess Medical Center, Boston, Massachusetts.

The primary aim is to validate the dichotomized REPS (high-risk versus low-risk for rNMB which corresponds to a REPS \>4 and \<4, respectively) for the outcome of postoperative respiratory complications with BIDMC data. The investigators will utilize the pre-defined variables identified to predict residual neuromuscular blockade (REPS) at BIDMC.

The secondary aim is to compare the predictive values of the dichotomized REPS with dichotomized train-of-four (TOF)-ratio (low TOF-ratio versus high TOF ratio which corresponds to a TOF-ratio \<0.9 and \>=0.9, respectively) for respiratory complications.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Non-cardiac surgery
* General anesthesia with intermediate-acting NMBAs (atracurium, cisatracurium, vecuronium, or rocuronium)
* Extubated in the operating room
* PACU after surgery

Exclusion Criteria:

* American Society of Anesthesiology (ASA) Physical Status Classification of 5 or 6
* Did not receive neuromuscular blocking agents
* Missing last covariates
Functional Neuroimaging of Postural Reconstruction

To study in two cross-sections of healthy volunteers, with single photon emission computed tomography (SPECT), the possible changes generated in the mid-term by two rehabilitation techniques: the postural reconstruction and the muscular stretching. The changes in the cortical activation patterns will be estimated during a non-specific position of the ankle, held static.

The influence of each technique will be estimated though the evidence of a change in the functional mapping of the areas activated during the defined motor task on healthy volunteers.

This is a monocentre, randomized study.

Eligibility Criteria:
Inclusion Criteria:

* male or female 18 to 35 years old

Exclusion Criteria:

* pregnant, lactating
The Effect of a Lighting Intervention on Sleep in Parkinson Disease

50 participants with Parkinson's disease will be recruited to complete actigraphy studies to assess sleep disturbances. For this, participants will wear an Actigraph for seven days. Thirty of these participants with sleep disturbance will go on to receive a tailored lighting intervention (TLI) to assess the effect on sleep, fatigue, and circadian entrainment via urinary melatonin levels.

Participants will undergo one week of baseline data collection using the actigraph and light meter and one night of an overnight urine collection. At the completion of the baseline week, the lighting intervention will be installed in the participants' home. Participants will be exposed to the lighting intervention for 2 hours each morning after awakening for 8 weeks. During the last week of the lighting, participants will be asked to wear the actigraph and light meter again for 7 days and collect one overnight urine sample. Participants will complete questionnaires before and after the intervention to further assess its effects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease and difficulties with sleep and/or cognition

Exclusion Criteria:

* There are no exclusion criteria
Do the Health Education Materials Developed in the Gynecology and Diseases Nursing Course Affect Students' Teaching Material Motivation and Material Design Self-Efficacy Beliefs?

Purpose: This study aimed to examine the effect of health education material developed by nursing students in gynecological health and disease nursing on students' teaching material motivation and material design self-efficacy belief.

Method: The study was conducted as a prospective randomized controlled study. n=86 (43=control, 43=intervention) students who took the Women's Health and Diseases Nursing course at Bartın University Faculty of Health Sciences Nursing Department between 30.10.2023-20.01.2024 and volunteered to participate in the study were randomized. It was conducted in two groups: intervention and control.In the research, data will be collected with the Data Collection Form prepared by reviewing the literature, Instructional Material Motivation Scale and Material Design Self-Efficacy Belief Scale. Descriptive statistics, Student t-test, Mann-Whitney U Test, Wilcoxon Signed Rank Test and Pearson correlation tests will be used to evaluate the data.

Aim: This study aimed to examine the effect of health education material developed by nursing students in women's health and disease nursing on students' teaching material motivation and material design self-efficacy beliefs.

Method: The study was conducted as a prospective randomized controlled study. n=86 (43=control, 43=intervention) students who took the Women's Health and Diseases Nursing course at Bartın University Faculty of Health Sciences Nursing Department between 30.10.2023-20.01.2024 and volunteered to participate in the study were randomized. It was conducted in two groups: intervention and control. In the research, data will be collected with the Data Collection Form prepared by reviewing the literature, Instructional Material Motivation Scale and Material Design Self-Efficacy Belief Scale. Descriptive statistics, Student t-test, Mann-Whitney U Test, Wilcoxon Signed Rank Test and Pearson correlation tests will be used to evaluate the data.

Eligibility Criteria:
Inclusion Criteria:

* Students who were over 18 years old,
* Students who spoke Turkish,
* Students who were not diagnosed with hearing impairment,
* Students who took the Gynecology and Diseases Nursing course,
* Students who had written consent
* Students who volunteered to participate

Exclusion Criteria:

* Not studying at Bartın University,
* students who did not take the Gynecology and Diseases Nursing course
Phase I Dose Escalation Study of Concomitant BIBF 1120 and BIBW 2992 in Patients With Advanced Solid Tumours.

The primary objective of this trial is to determine the Maximum Tolerated Dose (MTD) of the combination of BIBW 2992/BIBF 1120 therapy administered concomitantly. The MTD will provide dosing recommendation for subsequent phase II trials in patients with metastatic cancer.


Eligibility Criteria:
Inclusion criteria:

1. Patients with confirmed histological or cytological diagnosis of advanced solid tumours and for whom no proven therapy exists or who are not amenable to established treatments.
2. Age 18 years or older.
3. Life expectancy of at least three months.
4. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
5. Patients previously treated and with asymptomatic brain metastases are eligible
6. Patients must have recovered from recent surgery.

Exclusion criteria:

1. Active infectious disease
2. Recent surgery within the last 4 weeks prior visit 1.
3. Chronic diarrhoea or gastrointestinal tract disease resulting in an inability to take oral medication
4. History of haemorrhagic or thrombotic events
5. Significant cardiovascular diseases within
6. Current peripheral neuropathy \> Common Terminology Criteria for Adverse Events (CTCAE) grade 1 except due to trauma
7. Untreated or symptomatic brain metastases or leptomeningeal disease.
8. Treatment with an Epidermal growth Factor-receptor (EGFR)- or Heregulin Receptor 2 (HER2) inhibiting drug or antiangiogenic drug.
9. Therapeutic anticoagulation.
10. Female patients of childbearing potential.
11. Known pre-existing interstitial lung disease
Incidence of BRUE Among the Hospitalized Infants: Towards a Change in Medical Practices?

The malaise of the infant represents a polymorphic pathology in its clinical presentation.

Due to the young age of the patients concerned and the parental anxiety generated, hospital management is necessary, for clinical and paraclinical evaluation and monitoring.

The practice of complementary examinations is guided by personal and family history, and the precise description of the discomfort as well as clinical examination of the child and assessment of his vital parameters.

However, in view of the particular terrain represented by infants under one year of age, a number of tests are carried out systematically, and therefore empirically, because they are not guided by the clinic.

These various tests can be invasive, anxiety-provoking for parents and generate a significant additional cost during hospital management.

An evaluation of the indication and interest of these tests is necessary in order to propose a homogeneous clinical and paraclinical management of the discomfort of the infant, in particular of discomforts of type BRUE (Brief Resolved Unexplained Events), as described in the 2016 American Academy of Pediatrics (AAP) recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Infant less than one year old
* Admitted to the paediatric emergencies of the CHRU of Nancy between 11/01/2019 and 04/30/2020 for discomfort

Exclusion Criteria:

* Child over one year old
* Reasons for consultation in paediatric emergencies other than "malaise";
Effect of Oral Procaterol on Postinfectious Persistent Cough

The purpose of this study is to investigate the effectiveness of oral procaterol in treatment of non-asthmatic patients who suffer from persistent cough following upper respiratory tract infection (URTI).

Persistent cough following upper respiratory tract infection (URTI) is a common problem in the clinical practice, namely post-infectious cough. The potential mechanisms are viral-induced airway epithelial damage that leads to 1) airway hyperresponsiveness and airway narrowing, 2) increase in vascular permeability resulting in airway edema, and 3) activation of inflammatory mediators from inflammatory cells resulting in airway smooth muscle contraction. It is usually spontaneously resolved, although various therapeutic trials have been used with unpredictable results. Regarding to bronchodilators, inhaled ipratropium was effective in reducing cough symptom in a small study (N=14). We conduct a double-blind randomized placebo-controlled trial to investigate the effectiveness of oral procaterol, as a bronchodilator, in non-asthmatic adult patients suffering from persistent cough post URTI.

Eligible patients who have cough lasting longer than 3 weeks post URTI with normal spirometry will be randomized to receive either placebo or procaterol (25 microgram twice daily) for 4 weeks.

The primary outcome is cough symptom score using Leicester cough questionnaire (LCQ). The secondary outcomes are pulmonary function tests (spirometry, impulse oscillometry) and exhaled nitric oxide and quality of life (SF-36). All outcomes are measured at baseline, 2 weeks, and 4 weeks. Bronchoprovocation test with methacholine is performed at baseline and 4 weeks to determine the provocative concentration of methacholine that induces falling of FEV1 \>or =20%. Adverse events will be recorded every visit.

Data analysis will be in both intention-to-treat and per-protocol fashion. A linear mixed-effect regression model will be applied to assess treatment effect on LCQ score, SF-36, and lung function. Within-subject variation will be fitted in the model as random effects whereas the treatment will be considered as a fixed effect. Time at measurement (i.e., 2- and 4-week) will also be included in the mixed model by treating it as fixed-effect. Marginal treatment effects between treatments and time will be then estimated and compared.

Eligibility Criteria:
Inclusion Criteria:

1. Having persistent cough that lasts longer than 3 weeks following URTI
2. Currently being a non-smoker
3. Having normal spirometry (FEV1\>or= 80% predicted)
4. Obtain consent form

Exclusion Criteria:

1. Having cough more than 8 weeks
2. Having history of allergic or intolerance to β2 agonist
3. Having diagnosis of asthma by physicians
4. Presence of wheeze or rhonchi on physical examination
5. Having radiographic evidence of pneumonia, tuberculosis or sinusitis
6. Having significant gastroesophageal reflux symptoms suggested by GERD-Q questionnaire (GERD-Q score \> 8)
7. Currently taking ACE-inhibitor
8. Being active smokers
9. Refuse to participate in the study
Effect of Maternal Choline Intake on Choline Status and Health Biomarkers During Pregnancy and Lactation

The purpose of this study is to investigate the effect of varied maternal choline intake on maternal/fetal biomarkers of choline status, genomic expression and metabolomic profiling.

Choline is a micronutrient used for the structural integrity of cell membranes, lipid transport/metabolism, methylation reactions and cholinergic neurotransmission. Prenatal and early postnatal choline exposure plays a critical role in brain development and cognition based on animal data. Although it is recognized that choline use is particularly high during pregnancy and lactation, the level of choline intake needed to optimize maternal and fetal health outcomes is unknown. The primary objective of this study was to investigate the metabolic and genomic effects of two doses of choline intake, 450 mg/d (the adequate intake level for pregnant women) and 900 mg/d in pregnant, lactating, and nonpregnant control women. A secondary objective was to examine the effect of extra maternal choline intake on the child's cognitive performance (i.e, learning, memory and attention). To accomplish these objectives, pregnant women (wk 27 gestation), nonpregnant control women, and lactating women consumed controlled choline intakes of 480 or 930 mg/d for 10 to 12 weeks. The basal diet provided 380 mg/d; supplemental choline chloride, 100 or 550 mg/d, was used to achieve the target intake levels. During the last half of the study, a small portion (\~ 20%) of the total choline intake was derived from deuterium labeled choline, a stable isotope. Blood, urine and/or breast milk were collected at baseline and at select timepoints throughout the study duration. For pregnant women, a maternal blood sample was obtained at the time of delivery along with a cord blood sample and the placental tissue. Genomic and metabolomic profiling were performed on the collected biological samples along with specific measurements of choline status. Non-invasive tests assessing cognitive function were performed on the children of the pregnant and lactating study participants. This controlled feeding study has also been extended to investigate dose-response relationships for other micronutrients including folate, vitamin B12, vitamin D, and biotin.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant (wk 27 gestation) or lactating (postnatal day 30) or nonpregnant
* Healthy
* Non-smoker

Exclusion Criteria:

* Liver or kidney problems
* Alcohol or illegal drug misuse/abuse