cyrilzakka/clinical-trials huggingface dataset:
The Effect of Animation-Assisted Information Video Viewing on Fear and Anxiety in Children Before Endoscopy Procedure

The aim of this study was to evaluate watching video about procedure on reduce anxiety and fear in children before the endoscopy.

Being admitted to a hospital is an inherently stressful event for both children and their parents, regardless of the reason In such a context where children experience multifaceted effects, it becomes imperative to ensure that their hospital experience is as positive as possible. Hospitalized children often undergo medical procedures such as blood sampling, venipuncture, invasive drug administration, lumbar puncture, and intrathecal drug administration. These interventions, whether diagnostic or therapeutic, are sources of fear and anxiety for them. With a surge in gastrointestinal system disorders in children, the use of endoscopy, both as a diagnostic and therapeutic tool, has become more prevalent. Pediatric nurses play a pivotal role in alleviating the fear and anxiety experienced by children and their families during medical procedures, ensuring a smoother adjustment to the process. Prior research indicates that children's fear and anxiety levels significantly decrease, and parental satisfaction rises when children are informed about impending medical procedures. Moreover, providing pre-procedure information has been linked to heightened treatment compliance, expedited recovery post-procedure, and a reduced reliance on analgesics. While tailored educational programs are highly effective in conveying information about medical procedures or diseases to children, their elevated cost restricts widespread implementation. Traditional, cost-effective teaching strategies such as oral presentations, brochures, and booklets, although tailored for school-age children, haven't demonstrated consistent efficacy in enhancing clinical results. It has been noted that insufficient information provision can make children reliant on parents for clarification, with most procedural details tailored to parental understanding. In response, evidence-based initiatives have been introduced to enhance educational quality, boost patient clinical outcomes, and ensure cost-effectiveness. Given children's developmental stage, diverse educational techniques have been employed to prepare them for medical procedures, including endoscopy. An emerging method involves utilizing cartoons, which, when effectively employed, blend entertainment with instruction.

Eligibility Criteria:
Inclusion Criteria:

* Children and mothers who voluntarily participated,
* who were aged 6-12 years,
* who know Turkish,
* who do not have a vision or mental problem at a level to watch the image.

Exclusion Criteria:

* children and mothers who not voluntarily participated,
* who were not aged 6-12 years,
* who don't know Turkish,
* who have a vision or mental problem at a level to watch the image.
Effects of Quinapril 40 mg With Alpha Lipoic Acid or Placebo on Diabetes and Hypertension

We will evaluate the combination of quinapril and alpha lipoic acid in patients with diabetes mellitus and hypertension. We will determine whether the combination of quinapril and lipoic acid as compared to quinapril and placebo provides benefit on systemic blood pressure and proteinuria.

The participant will be randomized to either quinapril 40 mg and alpha lipoic acid versus quinapril 40 mg and placebo for 8 weeks. There will be a wash out period of 4 weeks between the cross over. The participant will be assigned the cross over for 8 weeks on the opposite therapy.

Eligibility Criteria:
Inclusion Criteria:

Patients who have a diagnosis of diabetes mellitus as defined by fasting blood glucose levels greater than ot equal to 126mg/dL and a systolic BP greater than 125 mm Hg at the time of screening will be included in the study. Patients may be on antihypertensive medication but not on ACE inhibitor or ARB therapy at the time of enrollment.

Exclusion Criteria:

Systolic blood pressure \> 180 mmHg Creatinine \> 2.5 mg/dl Glycosylated hemoglobin \> 7.5% Congestive heart failure (NYHA Class II, III or IV) Coronary angiography planned prior to baseline sampling Chronic autoimmune disease Chronic inflammatory disease or known cancer in evolution life expectancy \< 1 year Immunosuppressives or treatment with any other investigational drug within the last 30 days Pregnant or nursing women Participants who experience any side effects to quinapril and/or alpha lipoic acid

Women of childbearing potential Women of childbearing potential enrolled in the study should use one of the acceptable methods of birth control as listed below

1. Abstinence, meaning a total lack of any sexual activity.
2. Oral contraceptives (the "pill"),
3. Contraceptive injections,
4. Intrauterine device,
5. Double-barrier method (diaphragm or condom + spermicidal cream),
6. Contraceptive patch, or
7. Male partner sterilization.

Pregnancy Any pregnancy that occurs during study participation must be reported to the Principal Investigator and the study coordinator at the earliest. The pregnancy must be followed up to determine outcome and status of the mother and child. To ensure subject safety, any subject that becomes pregnant during the study will be discontinued from the trial.
An Animation- Versus Text-based Computer-tailored Game Intervention to Prevent Alcohol Consumption in Adolescents

This study consists in the design, implementation and evaluation of an animation (Alerta Alcohol 2.0)- versus text-based (Alerta Alcohol) computer-tailored game intervention aimed to prevent alcohol consumption and binge drinking (BD) in Spanish adolescents. A Cluster Randomized Controlled Trial (CRCT) is conducted to test the effectiveness of Alerta Alcohol versus Alerta Alcohol 2.0 in students aged 14 to 19 years across 24 high schools from Andalusia (southern Spain), which are randomized either to the experimental (EC-1, EC-2) or the control conditions (CC).

Alcohol use and misuse, and particularly, BD in adolescents are a highly prevalent healthcare problem that associates physical and mental health complications and community implications. The Alerta Alcohol and Alerta Alcohol 2.0 programs are based on the I-Change Model. A CRCT is carried out. The schools from Andalusia are randomized either to the experimental (EC-1, EC-2) or the control conditions (CC). The EC-1 receives an online intervention (Alerta Alcohol, which has adapted from a previous version) with personalized health advice, using textual feedback and several gamification techniques, and consists of nine sessions (performing seven of them at the high school): session 1 or baseline, sessions 2 and 3 where adolescents are provided with answers related to their views to provide highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence and self-efficacy; sessions 4, 5, 7 and 8 are reinforcement sessions (booster sessions) and sessions 6 and 9 are follow-up questionnaires at six and twelve months. The EC-2 receives an improved version of Alerta Alcohol (Alerta Alcohol 2.0) using animated videos and new gamification strategies. The CC just completes the baseline and the evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list). To test the effectiveness, the primary outcome is BD within 30 days prior to evaluation and alcohol use (high-intensity drinking, weekly and any consumption) in the previous week as secondary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Students aged 14 to 19 years.
* Enrolled in Andalusian public or private high schools.
* Access to the Internet at the schools and the use of computer, mobile or tablet is allowed.
* Access to the Internet in their homes.

Exclusion Criteria:

* Language barriers.
* Previous participation in prevention programs for BD.
New Urethral Reconstruction in Robot-assisted Laparoscopic Radical Resection

The purpose of this clinical trial is to compare new reconstruction and anastomosis in robot-assisted radical laparoscopic resection It will also understand the possibility of exploring new reconstruction in completely solving patients' postoperative urinary incontinence The main questions it aims to answer are:

Is there a significant improvement in urinary control in patients with new reconstruction compared with patients with anastomosis? The researchers compared the new reconstruction with anastomosis in robot-assisted laparoscopic radical resection to see if the new reconstruction improved urinary incontinence after operation.

Participants will:

The intervention group adopted the new reconstruction proposed by our team; End-to-end anastomosis was performed in non-intervention group.

It is one of the most common malignant tumors in urology, and its incidence rate is the second among male malignant tumors in the world. In recent years, with the economic and social development in China, the incidence rate has increased year by year, which seriously threatens the Radical resection is the current treatment plan. Although radical surgery can prolong the survival time of patients, because of the surgical injury, the incidence of urinary incontinence and sexual function after operation is high, which greatly affects the physiological health, mental health and social function of patients.

In order to solve the above problems, Professor Shi Benkang's team of Urology Department of Qilu Hospital of Shandong University improved the existing urinary tract reconstruction after consulting a large number of related literatures and combining with the new findings of our team's previous anatomical work, which needed to be carried out under Da Vinci Xi surgical system. By continuously suturing the fascia on the surface of levator anal muscle and the posterior dorsal median ridge (MDR) and Dirichlet fascia of the lateral tissue, it achieved the purpose of protecting the apical saccular tube bundle (NVB) and maintaining the stability of the length of vascular and nerve lengthening function in the posterior MDR We found that the postoperative urinary incontinence of patients with new reconstruction technique is obviously better than that of anastomosis, which provides a new idea for improving the postoperative urinary incontinence of RARP patients.

Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18 years old, confirmed by puncture pathology as prostate cancer
* The tumor has no extensive distant metastasis, or has reached a resectable state through neoadjuvant chemotherapy and endocrine therapy
* Willing to accept robot assisted laparoscopic radical prostatectomy

Exclusion criteria:

* Tumor metastasis cannot achieve curative effect through surgery
* Concomitant severe cardiovascular and cerebrovascular complications
* Merge severe mental and neurological disorders
* Poor liver and kidney function
* Refusal to accept robot assisted laparoscopic radical prostatectomy
Investigating the Diagnostic Potential of Tear Proteins in Cancer - A Pilot Study

This Pilot Study is to investigate the tear proteins in a multitude of cancer types and indulge in biomarker discovery to manufacture simple, accurate, and novel tear-based diagnostic tests.

The Pilot Study is an observational study to investigate the diagnostic potential of tear proteins for Breast, Ovarian, Prostate, Melanoma, Pancreatic, and Colon cancer. In this pilot study, we use lacrimal gland fluid (tears) as a liquid biopsy source for investigating the protein repertoire and conducting biomarker discovery studies with a goal to develop new tear-based tests that can detect crucial cancer-related biomarkers in the pan-cancer types.

Proteomic studies on tears have shown to express between 500-1500 proteins with \~35% overlap with serum proteome. The easy accessibility of tear fluid with minimal post-processing procedures and better access to lower molecular weight proteins make tears an ideal source to identify commonly associated cancer biomarkers.

Additionally, the results from this study will aid in improving our understanding of the cancer types and commonalities that exist between them.

Eligibility Criteria:
Inclusion Criteria:

* 18-100 years of age
* Presenting for the evaluation of an abnormal exam or test (mammogram, ultrasound, MRI, PET, etc.)
* Presenting for the evaluation of a palpable lump or mass
* Presenting with a mass may be pre or post-biopsy/diagnostic as long as there is a portion of the mass remaining.
* Have been diagnosed but have not received treatment

Exclusion Criteria:

* Less than 18 years of age OR more than 100 years of age
* Concurrent eye infection or trauma
* Acute conjunctivitis
Preliminary Data for Breath Biofeedback of Dietary Compliance

The investigators ultimate goal is to test the hypothesis that immediate feedback of dietary adherence will enhance compliance to a weight loss program. This study deals directly with gathering the needed preliminary data for a grant submission.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females age 18 or older

Exclusion Criteria:

* Chronic disease
Epidemiology of Ulcerative Colitis and Crohn's Disease in Non Jewish Israel Population

The aim of the present study was to describe the incidence and prevalence of IBD in non Jewish Israel population

We are interest to collect the detail of gender, age, duration of the disease and therapy

To obtain the information we wont to contact each physician by e-mail, phone , and fax .

Eligibility Criteria:
Inclusion Criteria:

* ulcertive colitis and crohn's disease patients

Exclusion Criteria:

* N/A
High Tibial Osteotomy With/Without Arthroscopy.

This study will compare Hight Tibial Osteotomy with or without arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO provides better clinical, radiological and laboratory outcomes.

Intraarticular knee lesions are often in patients with early stages of osteoarthritis. The most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. Degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. In the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. Cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. By this time the choice of performed surgery depends on surgeons personal assessment. The investigators believe that concomitant intraarticular procedures added to HTO will provide better clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination
* Intraarticular lesions in MRI
* Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests

Exclusion Criteria:

* no informed consent to participate in the study
* age under 18 years or above 65
* multilligament injury or single plane knee instability
* another musculoskeletal disorders in lower limb
* lower limb deformity requiring axis correction below 4o or above 12.5o • joints inflammatory diseases
* ASA score \> II
Adherence Support Intervention for Persons Living With HIV/AIDS (PLWHA) on Antiretroviral Therapy (ART) in Estonia

The specific aim of the study is to assess antiretroviral therapy adherence and evaluate the impact of a situated treatment adherence intervention program among persons living with HIV/AIDS on antiretroviral therapy in Estonia.

Specific antiretroviral therapy (ART) can suppress HIV replication and consequently preserve the functioning of immune system. ART is a lifelong treatment with several different concomitantly administered oral medications. According to studies, low adherence to treatment is directly related to knowledge and beliefs about ART.

Studies have shown the success of different interventions increasing adherence to ART, but additional studies need to be carried out in order to determine the most effective components of the interventions and the methods most suitable considering the local context, that could be easily incorporated into the working routine of an medical institution (clinic) with limited extra resources.

Primary locations to implement activities directed at improving treatment adherence are medical institutions, i.e. the departments of infectious diseases where persons living with HIV/AIDS receive their ART.

The aim of the study is to conduct a small-scale intervention (randomised controlled) study implementing a brief adherence counseling targeting persons receiving ART.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* aware of the HIV-positive status for at least 3 months
* ≥ 18 years of age
* speak and read either Estonian or Russian
* receive or start (on recruitment date) antiretroviral therapy

Exclusion Criteria:

* pregnant
* under the influence of alcohol or (illicit)drugs
Compassionate Use of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria

This program is designed to provide access to pozelimab and cemdisiran and document the long-term safety of pozelimab and cemdisiran combination therapy in patients with paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare immune disease that causes red blood cells in your body to break apart.


Eligibility Criteria:
Key Inclusion Criteria:

1. Patients who have completed either the end of treatment visit of the open-label treatment period or open-label extension period in one of the following parent studies:

   * An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria (R3918-PNH-2050 \[NCT05744921\])
   * A Randomized, Open-Label, Two-Arm Study to Evaluate the Safety, Efficacy, and Pharmacodynamic Effects of Pozelimab and Cemdisiran Combination Treatment in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy (R3918-PNH-2092 \[NCT04811716\])
   * A Single Arm, Open-Label Study to Assess the Safety, Efficacy, and Pharmacodynamic Effects of Pozelimab and Cemdisiran Combination Therapy in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Switch from Eculizumab Therapy (R3918-PNH-20105 \[NCT04888507\]). Note: In some countries, patients that would normally enter into the R3918-PNH-2050 (NCT05744921) parent study before entering this expanded access program, may be given the opportunity to skip R3918-PNH-2050 (NCT05744921) and go straight into this expanded access program, with Regeneron's permission
2. Patients who have been enrolled in R3918-PNH-2022 (NCT05131204), with Regeneron's permission
3. Willing and able to comply with clinic visits and related standard-of-care procedures
4. With Regeneron's permission, patients who have been enrolled in other PNH studies as appropriate

Key Exclusion Criteria:

1. Significant history or concerns of non-compliance that could impact the patient's safety per the treating physician
2. Any new condition or worsening of an existing condition which, in the opinion of the treating physician, would make the patient unsuitable for enrollment or could interfere with the patient participating in or completing the program

NOTE: Other protocol defined inclusion / exclusion criteria apply
Nicotinamide Adenine Dinucleotide and Skeletal Muscle Metabolic Phenotype

This study is designed to assess the physiological consequences of elevating Nicotinamide Adenine Dinucleotide (NAD+) availability using Nicotinamide Riboside (NR) supplementation in skeletal muscle tissue, and examine its effect upon muscle metabolic phenotype.

-NAD+ sensitive metabolic decline in ageing, including sarcopenia, leads to a reduction in energy metabolism, contribute to chronic inflammation, disposing individuals to metabolic disease and overall decreased later-life health. Prominent metabolic changes include a decline in NAD+ content and deterioration in muscle NAD+ mediated signalling and mitochondrial function, ultimately compromising skeletal muscle and whole body energy homeostasis.

The most efficient means to boost NAD+ in muscle appears to be oral delivery of NR, and participants will be supplemented with 1000mg NR (2x x250mg tablets twice daily) for 3 weeks.

* Hypothesis: elevating skeletal muscle NAD+ bioavailability using NR supplementation will increase markers of mitochondrial function and that will manifest as a more favourable metabolic profile.
* Study Setting: the study will be carried out at the NIHR/Wellcome Trust Clinical Research Facility, Queen Elizabeth Hospital Birmingham.

Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 70-80 years
* BMI 20-30kg/m2
* Participants who are able to discontinue aspirin for 3 days prior to the muscle biopsy
* Participants who are able to discontinue statins and vitamin D supplements for a week before the second visit and for the duration of the study

Exclusion Criteria:

* Serious active medical conditions including inflammatory diseases or malignancies
* Significant past medical history including diabetes mellitus, ischaemic heart disease, cerebrovascular disease, significant respiratory disease requiring medication, epilepsy
* High blood pressure (BP\>160/100mmHg)
* Oral Anticoagulants (like Warfarin, Dabigatran, Rivaroxaban) or Clopidogrel therapy which will increase the risk of bruising following a muscle biopsy
Combination of Cryosurgey and NK Immunotherapy for Recurrent Ovarian Cancer

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to recurrent ovarian cancer.

By enrolling patients with recurrent ovarian cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction