cyrilzakka/clinical-trials huggingface dataset:
The Effect of Web-based Education on Psychomotor Skills Education in Nursing

Objective: This research was conducted to evaluate the effect of web-based education on psychomotor skills teaching and information levels in nursing students.

Materials and Methods: The study was conducted as a randomized controlled clinical trial. The universe of the research consisted of first-year students of the nursing department of a university. The sample of the study consisted of 90 students, experimental and control group. At the beginning of the study, the drug administration course was explained theoretically to all students. Psychomotor skill teaching was demonstrated to both groups in the laboratory with demonstration technique. Then, pre-test data were collected. Students in the experimental group were given a link to the web page where they could watch the clinical knowledge and skills teaching video and a user profile was created. The students had the opportunity to watch and repeat the training videos and lecture notes as much as they wanted for two weeks. In the last stage, the knowledge and skill level of both groups was measured again and post-test data were collected. In order to collect data, intravenous-intramuscular injection skill checklists and drug administration knowledge tests created by the researchers were used.

In today's conditions, depending on the developments in computer and technology, it is inevitable to utilise internet technologies in teaching environments. At this point, Web Based Education (WBE) applications emerged with the use of internet technologies. Many education institutions, especially at higher education level, continue to carry out serious research and development studies in this field as well as realising WBE applications. It was observed that the knowledge level of first-year nursing students about drug applications, intramuscular injection and intravenous catheter insertion skills can be improved with web-based education.

Eligibility Criteria:
Inclusion Criteria:

* Students who volunteered to participate in the research,
* who took the nursing basics course for the first time,
* who did not graduate from a health vocational high school or any associate or undergraduate degree related to health departments,
* who had internet access,
* who had a smart phone or computer were included in the study.

Exclusion Criteria:

* Having any psychological diagnosis,
* İncomplete or incorrect filling of the forms.
Phentermine/Gastric Band Weight Loss Study

This is a prospective, randomized, double-blind controlled trial. The goal is to show whether the administration of daily oral Phentermine will augment patient weight loss and resolve obesity associated comorbidities following gastric band operation.


Eligibility Criteria:
Inclusion Criteria:

* Adult age 18-65
* BMI 35-55
* Approved for gastric band operation

Exclusion Criteria:

* A known allergy to Phentermine
* Take medications for Attention Deficit Disorder (ADD)
* Monoamine oxidase inhibitors (MAOI)for depression
* Selective serotonin reuptake inhibitor (SSRIs)for depression
* History of heart problems (congested heart failure, coronary artery disease,cardiac stents, cardiac arrhythmias
* Hyperthyroidism
* Glaucoma
* Psychosis
* History of drug abuse
* Uncontrolled hypertension (diastolic \>85)
A Gardening Program to Assess Unhealthy Lifestyle Contributions to Summer Weight Gain in Children

The purpose of this study is to examine the impact of a summer gardening program on summer weight gain in overweight middle school children.

In the past two decades, the combination of unhealthy eating and physical inactivity has contributed to doubling the percentage of children and adolescents who are overweight. Childhood overweight is known to lead to increased risk for several morbidities in childhood and into adulthood including type 2 diabetes mellitus, hypertension, and cardiovascular disease. Recent data shows that children experience greater and more variable increases in BMI during summer vacation than during the school year. Our project aims to determine whether summer weight gain is due to a decrease in physical activity or an increase in daily calories as well as to assess the effectiveness of a summer gardening program on preventing summer body fat gain. We will randomize 40 middle-school children who are above the 95th percentile for BMI into either a control or intervention group. The control group will receive the standard of care and the intervention group will participate in Garden Fit, a summer gardening project at Troy Gardens in Madison, WI. As part of Garden Fit, subjects will participate in weeding, landscaping and trail maintenance activities as well as preparing meals twice a week with fresh foods from the gardens. We hypothesize that summer weight gain is due to a worsening of healthy lifestyle (decreased physical activity from school to summer and increased eating of high calorie snacks). Additionally, we hypothesize that an intervention that increases physical activity and provides increased access to healthy foods will reduce the trend of summer BMI increase.

Eligibility Criteria:
Inclusion Criteria:

* Middle school child aged 10-14 years
* BMI at or above the 85th percentile for height and weight
* Able to attend 8-week summer program and clinic visits

Exclusion Criteria:

* Any known metabolic disorder
* Any physical disability that prevents or limits physical activity
* Claustrophobia
Study of the Treatment of Algerian Patients With Early Rheumatoid Arthritis

This non-interventional, descriptive, cross-sectional and multicenter study will examine the treatment of rheumatoid arthritis progressing for less than two years in the Algerian population. Current drug therapy as well as disease status and patient function will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis progressing for \< 2 years.

Exclusion Criteria:

* Rheumatoid arthritis progressing for \< 3 months.
* Rheumatoid arthritis onset at \< 18 years of age.
* Participation in another clinical study.
* Rheumatoid arthritis related connective tissue disorder.
* Any neuropsychological disorders.
Excisional Vacuum-Assisted Breast Biopsy

The goal of this prospective cohort study is to evaluate the possibility of vacuum-assisted excisional biopsy (VAE) to completely remove the pathology in case of small lesions for Atypical Ductal Hyperplasia (ADH) and low-intermediate grade Ductal Carcinoma in Situ (DCIS).

Surgery is the current standard of care of breast lesions like the Ductal Carcinoma In Situ (DCIS) and the Atypical Ductal Hyperplasia (ADH). However, the survival benefit of surgical resection in patients with such lesions appears to be low, especially for ADH and low-grade DCIS where comorbidity of surgery and prior depression have been reported as important factors related to worse quality of life in these women.

Patients with suspicious breast lesions (BIRADS\>3) who are candidates for vacuum assisted breast biopsy will be prospectively select and enroll if the radiological lesion diameter is less than 15 mm.

The investigators will select those patients in whom after an initial sequence of sampling (12 cores), and will check the complete macroscopic removal of the lesion (with radiograms of the biopsied part of the breast). Those patients (complete macroscopic removal, with real-time verification during the procedure) will be randomized into two groups. A first group of patients will finish the biopsy procedure after the first collection sequence (12 cores, 3 grams of tissue taken and complete macroscopic removal). A second group of patients (randomized subdivision) will undergo a second sequence of biopsy samples (other 4 cores and 1 gram of tissue taken) in the same session: the material collected will be sent separately to the pathologist.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspicious breast lesions (BIRADS \>3)
* Patients with a lesion \<= of 15mm.
* Capable and willing to comply the specific informed consent form
* Patients with ADH biopsy results or low intermediate-grade DCIS
* Patients who will undergo surgery

Exclusion Criteria:

- Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
Improving Self-Care of Behavioral Variant Frontotemporal Dementia Caregivers

The research study is being conducted to evaluate the efficacy of a virtual support intervention to reduce stress and poor self-care for caregivers of persons with behavioral variant Frontotemporal Degeneration (bvFTD) compared to receiving health information alone.

Informal caregivers of persons with Frontotemporal degeneration (FTD) are an understudied population with unique needs. FTD is a common cause of young-onset dementia with no known cure. Behavioral variant FTD (bvFTD) is the most common of the FTD syndromes and involves a progressive disorder of emotional regulation and personality, and significant impairment in executive function. bvFTD caregivers face unique challenges which are particularly stressful, including young age at which the disorder appears, behavioral symptoms like apathy and disinhibition that are severe and appear early in bvFTD, and the lack of appropriate supportive services. Indeed, numerous studies have demonstrated that stress, depression and burden are higher in FTD caregivers than in any of the other ADRDs, yet caregiver interventions tested in specifically in the FTD population have been limited to a few small studies that focus on education around patient behavior management, not caregiver self-care.

The research study is being conducted to evaluate the efficacy of a virtual support intervention to reduce stress and poor self-care for caregivers of persons with behavioral variant Frontotemporal Degeneration (bvFTD) compared to receiving health information alone.

30 caregivers will be randomized 1:1 to a health information: health information + health coaching group. Catered information will be delivered via tablets over 6 months with testing dispersed at baseline, 1 month, 3 months, and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Informal caregiver providing care at least 8 hours/week
* Reporting poor self-care on screening (Health Self-Care Neglect Scale, score ≥ 2)
* Able to complete the protocol, e.g., adequate vision and hearing, English speaking
* Caregiver of a patient diagnosed bvFTD

Exclusion Criteria:

* Participation in another support randomized, controlled trial
* Untreated major psychiatric illness (Use of anti-anxiety/anti-depressant medicines is acceptable and will be adjusted in analysis if group imbalance is identified.)
* Caregiver with Cognitive Impairment based on Telephone Interview for Cognitive Status (TICS) score \<25
ASP8825 - Pharmacokinetics Study in Patients With Impaired Renal Function and Haemodialysis

The objective of this study is to evaluate the pharmacokinetics and safety of ASP8825 in patients with impaired renal function and haemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Body weight: ≥40.0 kg and \<80.0 kg
* Body mass index BMI: ≥16.0 and \<30.0 \[BMI= Body weight (kg)/(Height (m))2\]
* For Renal impairment patients: Patients with eGFR by GFR predictive equation for Japanese within \< 50 mL.min/1.73m2 at screening and who is not undergoing dialysis
* For Haemodialysis patients: Patients who receive dialysis at screening
* Patients whose treatment regimen (including diet) for renal impairment or complications remain unchanged within 14 days prior to dosing, or patients who receive treatments (including diet) that need not to be changed during the period from 14 days before dosing to follow-up examination in the opinion of the investigator or sub-investigator.
* Female subjects who agree use effective contraception starting at informed consent and throughout the study period

Exclusion Criteria:

* Patients with a complication or history of the inappropriate for this study (except for a complication of primary disease for renal dysfunction, like diabetes etc., or complication of hypertension or anemia etc.)
* Patients with a complication or history of recurring alimentary disease
* Patients with a history of gastrointestinal surgical operation
* Patients with a complication of severe heart disease
* Patients with a complication or history of malignant tumor (However, a patient without recurrence of the malignant tumor for more than 5 years after the treatment may be eligible for the study.)
* Patients judged ineligible by the investigator or sub-investigator based on the results of medical examination, vital sign, 12-ECG and laboratory test
* Patients who have an Hb value \<9g/dL at screening
* Patients who received or are scheduled to receive any study drugs in other clinical trials or post-marketing studies within 120 days before screening
* Patients who received or are scheduled to receive medications within seven days before the dosing of the investigational drug
* Patients who previously received administration of Gabapentin or ASP8825
Validation of uHear™ as a Screening Tool to Detect Hearing Impairment in Elderly Cancer Patients Within a Comprehensive Geriatric Assessment

Over the last few years, there has been a considerable interest in the development of screening tools to assess the capability of elderly cancer patients to tolerate anti-cancer treatment. Therefore, the NCCN Guidelines in Senior Adult Oncology recommend an assessment of co-morbid conditions that are likely to interfere with cancer treatment and tolerability. As presbyacusis is common in an older population, elderly cancer patients are at high risk for social isolation and a reduced quality of life. Therefore, in this project the investigators aim to validatie uHear™ as a quick and reliable screening tool to screen for presbyacusisf in routine clinical oncology practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients should have reached the age of 70 or more at enrolment
* Histologically confirmed diagnosis of solid cancer or hematologic malignancy. All stages of cancer are eligible
* Patients should be fluent in Dutch or French
* Patients must receive their primary oncology care in the participating hospital
* Patients should be cognitively capable of performing the audiology assessment
* Patients should have signed informed consent

Exclusion Criteria:

* Patients who do not match the above inclusion criteria
* Patients who are visiting the oncology clinic for a second opinion and do not wish to be treated in this clinic
* Patients presenting with clinically diagnosed Ménière's disease, retrocochlear hearing loss, autoimmune inner ear disease, fluctuating hearing loss or a history of sudden sensory neural hearing loss
* Patients who already have a hearing aid or a previously diagnosed hearing loss
Ntraperitoneal Thermal Perfusion Combined With Chemotherapy Versus Chemotherapy

In view of the existence of malignant ascites in patients with advanced pancreatic cancer, we put forward the heat abdominal cavity perfusion chemotherapy combined albumin paclitaxel and gemcitabine compared with albumin paclitaxel and gemcitabine prospective clinical study, to assess abdominal albumin hot perfusion chemotherapy combined control of ascites and taxol in improving patients' quality of life, survival, exploring the feasibility of celiac hot perfusion chemotherapy combined albumin paclitaxel and side effects.


Eligibility Criteria:
Inclusion Criteria:

* Participate voluntarily and sign informed consent;
* Age ≥18 years old and ≤80 years old, regardless of gender;
* Physical condition ECOG 0 \~ 2;
* The diagnosis of pancreatic adenocarcinoma was confirmed by pathology;
* Peritoneal metastasis was confirmed by ascites cytology, or was pathologically confirmed by surgical exploration and biopsy;
* Expected survival ≥3 months;
* No serious abnormal blood system, heart and lung function and immune deficiency (refer to respective standards);
* Blood routine indicators: white blood cell (WBC) ≥3 × 109/L;Absolute count of neutrophils (ANC) ≥1.5 × 109/L;Platelet (PLT) ≥100 × 109/L;Hemoglobin (Hgb) ≥9 g/dL;
* Blood biochemical indexes: AST (SGOT) and ALT (SGPT) ≤2.5 × upper limit of normal value (ULN);Total bilirubin (TBIL) ≤ULN;Serum creatinine (CRE) ≤1.5 × ULN;
* Coagulation function: Prothrombin time (PT), international standard ratio (INR) ≤1.5 × ULN;
* Comply with the study visit plan and other program requirements.

Exclusion Criteria:

* Accompanied by other systemic malignant tumors;
* Received any form of anti-tumor therapy, including interventional chemoembolization, ablation, radiotherapy, chemotherapy, tumor palliative resection and molecular targeted therapy;
* Used any other study drugs within 5 weeks before enrollment;
* Central nervous system diseases, mental diseases, unstable angina pectoris, congestive heart failure, severe arrhythmia and other serious diseases that cannot be controlled;
* Uncontrolled infection, bleeding, pancreatic leakage, bile leakage, or other postoperative complications during baseline examination;Acute and chronic metabolic acidosis (including ketoacidosis and lactic acidosis) has not been corrected.
* A history of allergy to study drugs or similar structured drugs;
* Pregnant or lactating women;
* Any conditions, including serious medical risk factors, medical conditions, and laboratory abnormalities, that may impair patient safety or the integrity of research data;
* Intestinal obstruction, extensive adhesion in the peritoneal cavity, abdominal inflammation, etc.
The Effect of Probiotic Lozenges on White Spot Lesion Development in Orthodontic Patients

The goal of this randomized clinical trial was to investigate the effect of probiotic lozenges on the development of white spot lesions (WSLs) compared to a positive control, and no treatment.

Background: Recently, the use of probiotics has emerged as a treatment for prevention of oral cavity diseases including periodontal problems, and initial caries. The objectives of this prospective randomized clinical trial was to investigate the effect of probiotic lozenges on the development of white spot lesions (WSLs) compared to a positive control, and no treatment. Methods: Quantitative light induced fluorescence (QLF) images were taken for three randomly allocated groups (intervention group, n=23; positive control, n=23; negative control, n=24) of patients undergoing orthodontic treatment in three separate occasions (T0: before the start of study; T1: at 6 weeks later; T2: at 3 months after the commencement of the study). Subjects in the intervention group were instructed to take one probiotic lozenge containing two strains of Lactobacillus reuteri twice daily. Sugar-free lozenges were used in the positive control group and no lozenges for the negative control group. The QLF images were analyzed using a dedicated software in order to quantitatively analyze each tooth. The primary outcomes measured were the number of newly developed lesions in each group, lesion area and amount of mineral loss (ΔF). Means and standard deviations were calculated using the Statistical Package for the Social Science (SPSS version 28, Chicago, IL, USA). Split plot ANOVA (SPANOVA) test for repeated measures was used to check differences within and between the three groups regarding lesion area and ΔF. To check which group is different from the others, Tukey's test was used.

Eligibility Criteria:
Inclusion Criteria:

* Healthy patients from both sexes
* Having full fixed orthodontic appliances with expected remaining treatment duration of at least 6 months
* Optimum oral hygiene
* Maximum of 3 restored teeth
* Absence of defective enamel formation in the form of hypocalcification or hypoplasia

Exclusion Criteria:

* Patients with poor oral hygiene
* Defective enamel
* Extensive restorations
* Gingival hyperplasia
* Salivary glands diseases
* Smoking, alcohol consumption, mouth wash use, antibiotic or probiotic intake in the last 3 months.
Fixed Dose Combination Versus Free Combination of Tiotropium and Olodaterol in COPD

This is a 4-week, multicenter, randomized, double-blind, parallel group and active controlled study.

Patients will be randomized (1 to 1 ratio) to a 4-week double-blind treatment period of either FDC (fixed-dose combination) of tiotropium + olodaterol (5/5 µg) plus placebo or the free combination of tiotropium 5 µg and olodaterol 5 µg; all administered via the Respimat® inhaler. The purpose is to show non-inferiority between the FDC and the free combination of tiotropium and olodaterol in patients with COPD.


Eligibility Criteria:
Inclusion criteria:

* Male or female patients.
* Patients 40 years of age or older.
* Patients with a smoking history \> 10 pack years.
* Diagnostic of COPD with Post-bronchodilator FEV1 (Forced Expiratory Volume in one second) \>= 30% and \<80% of predicted normal and Post-bronchodilator FEV1/FVC (Forced Vital Capacity) \<70% at screening.
* Symptomatic patients with CAT (COPD Assessment Test TM) score \>= 10 at screening.
* Further inclusion criteria apply.

Exclusion criteria:

* COPD exacerbation or symptoms of lower respiratory tract infection within 6 weeks prior to screening.
* Patients with a current diagnosis of asthma.
* Further exclusion criteria apply.
Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia

The purpose of this study is to examine the effectiveness of brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) in comparison with TAU alone for refractory insomnia among patients with major depression in partial remission.


Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV major depressive disorder, as ascertained by the Structured Clinical Interview for DSM-IV Axis I disorders (SCID)
2. Either sex, between 20 and 70 years of age at the time of entry into the trial
3. Outpatient at the time of entry into the trial
4. For the index episode, patients have to have already been on two types of adequate doses of antidepressants for no shorter than 4 weeks for each medication or already on two types of antidepressants for 8 weeks in total even if the doses of the drugs have not been adequate due to side effects. The medication has not been changed for at least 4 weeks prior to the study entry.
5. A score of 2 on at least one of the three sleep items of the 17-GRID-HAMD and a score of 8 or more on the ISI.
6. A score between 8 and 23 on the 17-GRID-HAMD.
7. Agreement to the requirements that i) no change of medication will be allowed during the first 4 weeks of their study period, and ii) all the treatment sessions both of bBT-I and of TAU will be audiotaped for the purpose of checking their adherence to the protocol

Exclusion Criteria:

1. Their mental or physical status at the time of entry into the trial is regarded as so critical as to need immediate hospitalisation
2. A serious suicidal risk, defined as a score of 3 or more on item 3 (suicidal ideation) of the 17-GRID-HAMD
3. Patients who have had or are having any structured psychotherapy (e.g. cognitive therapy, or family therapy) at the time of entry
4. Patients with current diagnosis of primary anxiety or personality disorder, insomnia associated with another sleep disorder, significant medical problems, current drug or alcohol substance abuse or dependence, or psychosis, or with a history of schizophrenia or bipolar disorder
5. Patients with duration of depression shorter than 2 months
6. Their insomnia is considered to derive from sleep apnoea or periodic limb movements during sleep, judged by their clinicians.
7. Patients who engage in work involving night-shift, which might influence sleep status
8. Patients currently taking methylphenidate or modafinil.