cyrilzakka/clinical-trials huggingface dataset:
Effectıveness Of Cognıtıve Behavıoral-Based Psychoeducatıon In College Students Wıth Smartphone Addıctıon

This study aims to determine the effectiveness of the group psycho-education program which is prepared as "cognitive behavioural-based", on college students' smartphone dependency levels. The research will be carried out on students studying at a private foundation University in 2019-2020 academic year. In this study, pre-test-final Test control group and follow-up measured experimental pattern will be used to determine the effect of Psycho-education program on smartphone dependency levels of college students.

A Personal Information Form and Smartphone Dependency scale will be applied to students who agree to participate in the study. By analysing the data results obtained from the data collection tools and passing the determined limit value, 94 people will be randomly selected, including 47 experiments and 47 control groups, from those who scored high on the smartphone dependency scale through the SPSS program using the power analysis method. Students will be informed about cognitive behavioural based psychoeducation and will be asked if they wish to participate in the training. Psychoeducation Practice 1 day per week, 60-90 min. sessions will take 8 weeks. At the end of the training, the final test will be applied to the experimental and control group. 3rd and 6th month follow-up measurements are planned to be carried out intermittently at the end of the month.

In the literature, it is observed that the number of intervention studies is very small, and no clear conclusions have been reached. In addition, the treatment of smartphone addiction in Turkey with cognitive-behavioural approach-based group psychoeducation program has not been studied before. In our country, where smartphone addiction is increasing every day, the importance of intervention efforts in this area is clear. It is anticipated that the intervention study on addiction reduction will be supportive for researchers and will be beneficial for people who need support for smartphone addiction. In this respect, it is thought that it will be a guiding work for future clinical and academic studies.


Eligibility Criteria:
Inclusion Criteria:

Being over 18 years old Higher smartphone addiction scale score

Exclusion Criteria:

-
Handgrip Training in Patients With Peripheral Artery Disease

The aim of this study is to analyze the effects of isometric handgrip training (IHT) on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will training isometric contraction for 12 weeks. In CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention cardiovascular measures will be obtained.

Meta-analyze studies have shown that 4 sets of 2 min of isometric handgrip training (IHT)reduces blood pressure (BP), reaching 10 mmHg for systolic and diastolic 7 mmHg in hypertensive patients after few weeks. However, using this protocol it was not observed any changes in BP in patients with peripheral artery disease. However, it is unknown whether reductions in BP does not occur after isometric handgrip training employing longer and protocol of IHT with more volume. The aim of this study is to analyze the effects of IHT on blood pressure of hypertensive patients with peripheral arterial disease. Will be recruited 30 patients, which will be randomized into 2 groups (15 per group), IHT and control group (CG). IHT group will hold three sessions per week with eight sets of two minutes of isometric contraction at 30% of maximal voluntary contraction and interval of two minutes between them, for 12 weeks. In the CG patients will be encouraged to increase the level of physical activity. In the pre and post-intervention, BP and cardiac autonomic modulationwill be assessed. Will be used to analyze two-factor variance for repeated measures, with group (IHT and CG) and the time (before and after 12 weeks) as factors and the post-hoc test of Newman-Keuls.

Eligibility Criteria:
Inclusion Criteria:

* Women in post-menopause phase without hormone replacement therapy
* Ankle-brachial index \<0.90
* Not severe obese (≥ 35kg/m2)
* Not present amputation in the limbs
* Have blood pressure levels lower than 160mmHg for systolic and 105mmHg for diastolic

Exclusion Criteria:

* patients will only be excluded if they make any medication changes before completing the intervention period or present any health problems that prevent physical activity.
Small Bowel Cleansing for Capsule Endoscopy in Pediatric Patients

The primary aim of this prospective, randomized and controlled study was to evaluate the effect of five bowel preparation regimens on small-bowel cleansing in a pediatric population. The secondary endpoints were to evaluate the safety and the effects of preparation on diagnostic yield of CE.

Capsule endoscopy (CE) is a well-known, non-invasive, diagnostic tool to evaluate small bowel diseases in adults and children. Unfortunately, because CE does not have functions which allow suctioning of fluid or washing the small bowel mucosa during the examination, its diagnostic yield can be limited by presence of debris, biliary secretion, bubbles and blood in the gut lumen that may hide relevant findings especially in the distal small bowel. In addition, CE sometimes fails to reach the cecum within the battery life of the capsule, resulting in a failure to visualize the distal small intestine. However, in children this problem is less frequent for the increased intestinal motility, which reduces the transit time of the capsule.

It was believed that cleaning the small intestine prior to examination would improve mucosal visibility during the endoscopy and, as a result, the diagnostic yield of the technique. Therefore, proposals were put forward based on preparations for other types of explorations, such as colonoscopies (2).

Some authors have already studied in adults the effect of bowel preparation on small-bowel visualization using different agents; the results of the published series are contradictory. To date, while there is evidence for a benefit from bowel preparation for CE, there is so far no consensus on an optimal preparation regimen. In addition, in children there are not studies on this topic. Therefore, overnight fasting before the examination still remains the proposed preparation for capsule endoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective Small Bowel capsule endoscopy in our Institution between 2 and 18 years of age were recruited for this study.

Exclusion Criteria:

* intestinal obstruction,
* suspicious impaired intestinal motility,
* history of gastrointestinal surgery
Aflibercept Plus Micropulse Laser Versus Aflibercept Monotherapy for Diabetic Macular Edema

Purpose: To evaluate the role of adjuvent micropulse laser with Aflibercept injections in the management of treatment naïve centre involving DME, looking at decreased treatment burden and increased efficacy as outcomes.

Methods: This was a prospective, single centre, randomized trial that included 40 eyes (40 patients) with previously untreated centre involved DME. Patients were randomly assigned to receive either Aflibercept plus micropulse laser (group A) or Aflibercept monotherapy (group B).

Patients were randomly distributed in a 1:1 ratio between the two studied groups. Group A received 3 monthly injections of Aflibercept 2 mg/0.05 mL (Eylea; Bayer, Berlin, Germany) as a loading dose, followed one month later by one 577 nm yellow micropulse laser session with monthly PRN Aflibercept injections. Group B received 3 monthly injections of Aflibercept 2 mg/0.05 mL as a loading dose, followed by monthly PRN Aflibercept injections. Patients in both groups were assessed one month after the end of loading phase; At this point, group A received the micropulse laser session and started PRN Aflibercept injections, while group B started PRN Aflibercept injections without receiving the micropulse laser session. After that, both groups were followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* patients were older than 18 with the clinical diagnosis of previously untreated centre involved DME documented by fluorescein angiography and central macular thickness (CMT) ≥ 300 µm on the spectral-domain OCT Best corrected visual acuity was better than 3/60 with Hb A1C less than 10%.

Exclusion Criteria:

* any previous treatment for DME, proliferative diabetic retinopathy, macular ischemia on fluorescein angiography, epiretinal membrane or tractional maculopathy on OCT, media opacity and any previous intraocular surgery with the exception of uneventful cataract surgery more than 6 months before the beginning of the study.
Nasogastric Decompression Following Pancreaticoduodenectomy

Pancreaticoduodenectomy (PD) remains the gold-standard operation for peri-ampullary neoplasms. Traditionally, gastric decompression via nasogastric intubation has been employed postoperatively to prevent nausea, vomiting, aspiration pneumonia, anastomotic leakage and delayed gastric emptying. Recently, the implementation of ERAS protocol recommended against routine use of nasogastric tube following PD. however, limited data exists surrounding the identification of those patients needing NGT decompression in the immediate postoperative period. Therefore, we initiated a large prospective randomized controlled trial to evaluate the clinical outcomes of patients who retained the NGT post-PD versus those who had it removed at the end of the procedure. This study aims to assess the effectiveness of nasogastric decompression in PD recovery, with the primary endo point being the need for and impact of NGT in the postoperative recovery. The secondary endpoint will examined the re-insertion rate of NGT and identify factors that necessitate its use in the immediate postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* All patients 18 years of age or older
* Patients undergoing successful pancreaticoduodenectomy for benign or malignant neoplasm.

Exclusion Criteria:

* Patients who does not complete the procedure due to locally advanced or metastatic disease discovered during the procedure.
* Patient who requires prolong postoperative intubation in the postoperative period.
Adjunctive Use of Hyaluronic Acid in Multiple Coronally Advanced Flap

The primary aim of this study is to evaluate whether the effect of HA in combination with XCM for the treatment of MAGRs with a multiple coronally advanced flap technique (mCAF) achieves better results than the XCM with mCAF alone in terms of recession reduction (primary outcome) and other secondary root coverage outcomes (e.g. complete root coverage, mean root coverage). Moreover, this study aims to compare secondary clinical variables (e.g. keratinized tissue width (KTW) changes, probing pocket depth (PPD) changes, volumetric gain (VG), etc.), also with a digital approach, the patient-reported outcome measures (PROMs e.g. pain, swelling, bleeding) and lastly the expression of molecular mediators of tissue healing/regeneration. The hypothesis of this study is that at 6 months and 1 year follow-up the mCAF with XCM+HA is superior to the mCAF with only XCM in terms of recessions reduction and secondary clinical variables, including PROMs.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old and able to sign informed consent
* At least 2 adjacent teeth with RT1 and/or RT2 gingival recessions without interproximal exposure of the CEJ (interdental gingival recession), at least one with a depth of ≥2mm with indication for root coverage treatment
* A minimum of 4 adjacent teeth (including the ones to be treated) in the region of interest
* Available to attend study related procedures (including follow-up visits)

Exclusion Criteria:

* Systemic diseases/medications which could influence the outcome of the therapy (e.g., uncontrolled diabetes mellitus);
* Current smokers (self-reported, any type of smoking), users of chewing tobacco, and drug/alcohol abusers;
* Pregnant or nursing women;
* History of previous periodontal surgery (mucogingival or other) on the teeth to be included;
* Furcation involvement in the teeth to be included;
* Presence of severe tooth malposition, rotation or clinically significant extrusion in the teeth to be treated;
* Presence of fixed or removable prosthesis in the area to be treated
Imiquimod Plus Antimony Immunochemotherapy for Cutaneous Leishmaniasis

This study will test whether addition of imiquimod to standard antimony therapy provides a significant benefit in subjects with newly diagnosed cutaneous leishmaniasis. Based on our previous results, we hypothesize that lesions in patients who receive the combined treatment of pentavalent antimony and imiquimod as a first line therapy will resolve more rapidly and produce less scarring than treatment with pentavalent antimony alone.


Eligibility Criteria:
Inclusion Criteria:

* Males/Females between 5 and 65 yrs
* CL diagnosis confirmed
* \>4 weeks time disease
* no prior anti-leishmanial therapy for CL
* negative pregnancy test
* informed written consent or parent consent for \<18yrs patients

Exclusion Criteria:

* \>25cm2 lesion(s)
* \>6 cutaneous lesions
* mucosal lesion
* previous exposure to Imiquimod or anti-leish treatment
* participation in another protocol within 30 days prior study
* other acute or chronic illness / medication that may interfere
* significant psychiatric illness
* anaphylaxis or severe allergic reaction to proposed drugs
* patients unlikely to cooperate
* concomitant infection
* pregnancy or breast feeding
Biochemical Effects of Remote Ischemic Pre-Conditioning on Contrast-induced Acute Kidney Injury

This a prospective, double-blind, sham-controlled, randomized clinical trial to study the effects of remote ischemic preconditioning on acute kidney injury, vascular and renal biomarkers in patients with non-ST elevation myocardial infarction and unstable angina undergoing coronary angiography and/or percutaneous coronary intervention.

The BRICK study is a prospective, double-blind, sham-controlled, randomized clinical trial in patients with non-ST elevation myocardial infarction and unstable angina undergoing coronary angiography and/or percutaneous coronary intervention who are at high risk for acute kidney injury. The study will investigate the effects of remote ischemic preconditioning before cardiac catheterization on rate of acute kidney injury and novel biomarkers of renal injury/protection within 48hrs of coronary angiography and/or percutaneous coronary intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patient with non-ST elevation myocardial infarction or unstable angina
* Referral for cardiac catheterization and percutaneous coronary intervention
* Contrast-induced acute kidney injury risk score of ≥11

Exclusion Criteria:

* Inability to give informed consent
* unstable blood pressure (systolic blood pressure \> 200 or \<90 mmHg)
* History of allergy to contrast media
* Peripheral vascular disease of upper limb
* Renal disease requiring dialysis
* Placement of arteriovenous fistula and arteriovenous graft
The Impact of Addiction Management Model on Digital Addiction and Psychological Resilience in Second School Students

Digital addiction has become a prevalent concern among adolescents, particularly middle school students. This study aims to develop and evaluate an addiction management model for 6th-grade students at risk of digital addiction. The model will combine standardized psychological resilience training with emotional freedom techniques to address both the behavioral and emotional aspects of digital addiction.


Eligibility Criteria:
Inclusion Criteria:

High risk of digital addiction as a result of the screening, Secondary school 6th grade students, Volunteering of the student and parent to participate in the research, The student must be able to speak, read and understand Turkish, The student does not have an auditory or mental disability that would affect his/her participation in the research.

Exclusion Criteria:

-
Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly Paclitaxel to determine the difference in progression free survival between the 2 groups. If results at that stage suggest a potential benefit then the trial will be developed further to accrue 70 more patients.

This is a prospective multicentre, randomised, open label, study comparing the efficacy and the safety of six 3-weekly cycles cabazitaxel versus 18 x weekly paclitaxel given as first line chemotherapy treatment in patients with HER2-normal metastatic breast cancer. Randomisation will be conducted by a 1:1 ratio.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Metastatic breast cancer fit to receive cytotoxic chemotherapy for metastatic disease
* Measurable disease as per RECIST 1.1
* HER2 negative defined as ICH 0+, 1+ or 2+ and FISH/SISH/CISH(ration\<2.0) in the case of IHC 2+
* ECOG performance status 0 or 1
* ER+ve or ER-ve
* Female age ≥18 years
* Anticipated life expectancy \> 6 months
* Haemoglobin \>10.0g/DL
* Absolute neutrophil count\>1.5 x 10\^9/L
* Platelet count\>100 x 10\^9/L
* ALT/SGPT\<1.5 X ULN
* Serum creatinine \<1.5 x ULN
* Negative pregnancy test for all women of child bearing potential

Exclusion Criteria:

* Grade ≥2 oral mucositis or peripheral or sensory neuropathy
* History of other malignancy
* History of severe hypersensitivity ≥grade 3 to polysorbate 80- containing drugs and taxanes
* Clinically significant cardiovascular disease
* Any acute or chronic medical condition
* Acute infection requiring systemic antibiotics or antifungal medication
* Sex hormones
* Administration of any live vaccine within 8 weeks
* Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5
* Participation in another clinical trial with an investigational drug within 30 days of randomisation
* Pregnant or breast feeding women
* Contraindications to the use of corticosteroid treatment
* HER2 Positive breast cancer
* Previous Paclitaxel chemotherapy in the adjuvant setting
* Previous cytotoxic chemotherapy for metastatic disease
* Palliative radiotherapy for metastatic disease within 4 weeks of randomisation
* Symptomatic brain metastases confirmed with CT/MRI brain
* History of other malignancy
* Grade 2
Better Pediatric Asthma Outcomes Through Chronic Care

This 3-year, multi-site study focuses on the translation of cost-effective methods to bring a chronic care model to the care of poor, minority, inner-city children with asthma, at risk of the worst outcomes for the leading chronic disease of children.

The specific aims are to:

1. Develop a computer support system to deliver peer-driven, patient-linked Guideline prompts at the point of care using affordable information technology;
2. Evaluate the effect of the Guideline prompt system on the process and outcomes (symptom control, health-related-quality-of-life, ED and hospitalizations) of asthma care; and
3. Evaluate the added effect on outcomes of family-focused, supportive education delivered by a community health worker.

The key product of the computer support system is a guideline prompt that serves as the mechanism for integrating patient specific data with standards of care. 548 children, ages 5-18, with physician diagnosed asthma, enrolled in one Medicaid Managed Care Organization in CT, and receiving care at one of four Federally Qualified Community Health Centers will be recruited. All sites will have access to the computer support system and the to-be-developed, Guideline-Driven Clinical Standards of Asthma Care. In Phase I (12 months), the effect of prompts delivered at the point of care on patient outcomes will be compared to the effect of no-prompt care. In Phase II (6 months), the effect of family-focused, supportive education will be assessed in combination with prompted care compared to no-prompt care and compared to no education. All patients will receive standard screening and outreach to keep appointments. Data will be obtained from medical records, medical and pharmacy claims data as well as patient and parent interviews at baseline and quarterly for 18 months.


Eligibility Criteria:
Inclusion Criteria:

* determined by provider to be asthmatic
* member of Medical Managed Care Organization partner group

Exclusion Criteria:

-
Outcomes Following Anterior Approach to Total Hip Arthroplasty

Osteoarthritis disables approximately 10% of people who are 60 years or older and compromises the quality of life of more than 20 million Americans every year. Osteoarthritis is caused by the breakdown of cartilage that lines the bones at your joints from daily wear and tear and results in pain and restricted function. Total hip arthroplasty (THA) or total hip replacement, is currently one of the most successful and cost-effective treatments used to eliminate pain and restore function in those suffering from osteoarthritis. There are multiple ways to perform a THA. The main difference between each type is the point of incision in relation to a muscle on the outer surface of your hip bone: gluteus medius. The incision performed can be anterior (in front of the muscle), anterolateral (in front and to the side of the muscle), or posterior (from the back). Each of these approaches has its own advantages and disadvantages, but there is no evidence available that makes one better than the other. The purpose of this study is to determine which of the three approaches to THA is the most effective. The main outcome that will determine the most effective approach is the functional ability of the patients included in this study at 52 weeks. The investigators will also compare whether the patient's: length of hospital stay, use of assistive devices, need for revision surgery, ability to return to work, ability to relieve pain, complication rate, and quality of life. The investigators hypothesize that the anterior approach will be the most effective approach in reducing the rate of post-operative complications after THA.


Eligibility Criteria:
Inclusion Criteria:

1. Men or women who are 18 years of age or older.
2. Primary diagnosis of hip arthritis (radiographically and clinically).
3. Patients undergoing an unilateral THA.
4. Provision of informed consent by patient.

Exclusion Criteria:

1. Patients being managed with alternative approaches (other than anterior, anterolateral or posterior THA) will be excluded.
2. Patients undergoing a revision THA.
3. Patients undergoing a bilateral THA.
4. Patients with infection around the hip (soft tissue or bone).
5. Patients who have had previous major hip surgery (hip arthroscopy is permitted) or hardware implanted in their hip.
6. Patients who are currently enrolled in another surgical intervention trial.
7. Patient has cognitive or language barriers that would limit completion of quality of life, pain, and function questionnaires in English.
8. Anticipated problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.