cyrilzakka/clinical-trials huggingface dataset:
Gamification Design in Evidence-Based Education for Clinical Nurses

The goal of this study is to compare the effectiveness of gamification versus group discussion in evidence-based practice (EBP) education for clinical nurses. It aims to improve learning outcomes and clinical application of EBP.

The main questions it aims to answer are:

Does gamification enhance the knowledge acquisition of clinical nurses in EBP? What barriers to evidence-based practice do nurses face? How does gamification affect cognitive load, self-efficacy, and attitudes towards EBP? Researchers will compare gamification to traditional group discussion methods to evaluate their impact on clinical practice.

Participants will:

Be clinical nurses from Tri-Service General Hospital with varying ranks and experiences.

Be randomly assigned to either the gamification group or the control group. Participate in EBP courses based on their clinical rank and experience. Complete pre- and post-intervention assessments and a six-month follow-up. Data collection will measure barriers to evidence-based practice, cognitive load, knowledge acquisition, self-efficacy, attitudes, course satisfaction, and practical application through written reports. Data analysis will use descriptive and inferential statistics to evaluate the effectiveness of the interventions.

This study aims to provide evidence on the most effective teaching methods for EBP, contributing to improved educational strategies and better clinical practices for nurses.

Eligibility Criteria:
Inclusion Criteria:

* Active clinical nurses aged 20-65. Clinical nurses within the hospital who registered for the workshop via e-learning.

Nurses with more than three months of work experience and a signed contract.

Exclusion Criteria:

* Nurses with less than three months of work experience or without a signed contract.

Participants cannot simultaneously attend both types of courses. Nurses at level N2 or above, nurses from other hospitals, nurse practitioners, or nursing supervisors are not included in this study.
Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery

Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass. If the great saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Now, the skill of endovascular treatment is developing rapidly, and lots of doctors think most of such patients could be treated with stent. The purpose of this trial is to compare stent and artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive treatment of stent can be considered in such patients.

This is a multi-center, prospective, randomized, controlled trial to compare the therapeutic effect of stent and artificial blood vessel bypass to chronic long occlusion of the superficial femoral artery. Totally 200 patients will be entered into the trial. The study population will consist of patients with long superficial femoral stenosis and occlusion lesion (≥15 cm), presenting symptomatic ischemia（Rutherford 3-6）. The lesion does not extend beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel infra-popliteal runoff to the foot.

Trial participants will be randomized to either stent group or artificial blood vessel bypass group.

Patients will be followed up for 3 years. Study examinations will be done at screening, procedure time, 1, 6, 12, 24 and 36 months after procedure.

This study will be conducted at 3 centers in Beijing, China.

Eligibility Criteria:
Inclusion Criteria:

* The patients volunteer to join the trial and sign the formal consent.
* The patients are ≥45 year-old and ≤80 year-old.
* The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6. The presentation is severe intermittent claudication, rest pain, ulcer or gangrene.
* The total length of the femoral and popliteal artery lesion(including ≥75% stenosis and occlusion) are at least 15cm.
* The femoral-popliteal artery has never received bypass or endovascular therapy before.
* No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
* No obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot.
* No surgical contraindications;no infection in operation region.
* No available saphenous vein.

Exclusion Criteria:

* Refuse random treatment.
* Previous operations on the superficial femoral artery.
* Acute lower extremity arterial thrombosis.
* Serious major organ failure.
* Allergic to the contrast agent or has contrast nephropathy.
* No clinical compliance or unfit to join the trial.
Safe Pregnancy by Infectious Disease Control

Malaria and sexually transmitted infections (STIs) are common in pregnant women in Africa and are important preventable causes of poor birth outcomes and maternal and infant mortality. This study investigated baseline characteristics of the population including: rates of STIs including HIV, prevalence of malaria and tuberculosis (TB) and resistance to common antimalarial drugs.

A cross-sectional observational study was conducted with 2008 pregnant women attending either Binza or Kingasani Maternity clinics in Kinshasa, DRC to determine baseline rates of STIs, TB and malaria. Data was collected for sample size calculation in a larger STI/Malaria and TB randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* older than or equal to 15 years of age
* pregnant
* presenting for antenatal care at one of the two target maternities for the first time during the current pregnancy
* willing to provide informed consent

Exclusion Criteria:

* refusal to participate in the HIV voluntary and counseling program at the maternity center or refusal to share HIV results with the study staff.
A Trial of Episil® Oral Liquid in Cancer Patients Suffering From Chemotherapy- and/or Radiation-induced Oral Mucositis

This is a randomized, multi-center, single-use, active-controlled, two-stage open study of episil®. The purpose of this study is to assess the local analgesic effect of episil® in cancer patients suffering from chemotherapy- and/or radiation-induced oral mucositis, which will provide scientific and reliable clinical data in the product registration in China.


Eligibility Criteria:
Inclusion Criteria:

* Male/female patient 18 years of age;
* Pathological histologic and/or cytological diagnosis of malignant tumor;
* Patients who are suffering from symptomatic oral mucositis (WHO grade 2 or above) during chemotherapy and/or radiotherapy during screening period;
* Patients who are suffering from pain inside the oral cavity caused by oral mucositis, and pain assessment by Likert scale (0-10) results in a score of at least 6 out of 10 during screening period and at enrollment on Day 1;
* Patients undergoing chemotherapy and/or radiotherapy: patients must have received at least one cycle of multiple-cycle chemotherapy regimen and/or have received multiple doses of radiation, prior to the enrollment on Day 1;
* Patients at Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 and 3; and
* Patients are able to provide written informed consent to participate in the study freely after the nature of the study and disclosure of data has been explained to the patients.
Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1

The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir (ISL/LEN) regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus (PWH) who are virologically suppressed (HIV-1 RNA levels \< 50 copies/mL) on B/F/TAF for ≥ 6 months prior to screening.

The primary objective is to evaluate the efficacy of switching to oral weekly ISL/LEN tablet regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 48.


Eligibility Criteria:
Key Inclusion Criteria:

* HIV-1 RNA \< 50 copies/mL for ≥ 6 months before screening, as documented by:

  1. One HIV-1 RNA \< 50 copies/mL immediately preceding the 24 week period prior to screening.
  2. Within 24 weeks prior to screening, if HIV-1 RNA results are available, all levels must be \< 50 copies/mL.
  3. During the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/mL is acceptable ("blip"), as long as it is not confirmed on 2 consecutive visits.
* Plasma HIV-1 RNA levels \< 50 copies/mL at screening.
* Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1.
* Individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception.

Key Exclusion Criteria:

* Prior virologic failure.
* Prior use of, or exposure to ISL or LEN.
* Active, serious infections requiring parenteral therapy within 30 days before randomization.
* Active tuberculosis infection.
* Acute hepatitis within 30 days before randomization.
* Hepatitis B virus (HBV) infection as determined below at the screening visit:

  1. Positive HBV surface antigen OR
  2. Positive HBV core antibody and negative HBV surface antibody. Note: individuals found to be susceptible to HBV infection (eg negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive HBV vaccination.
* Active hepatitis C virus (HCV) coinfection, defined as detectable HCV RNA. Note: individuals with prior/inactive HCV infection (defined as undetectable HCV RNA) may be enrolled.
* Any of the following laboratory values at screening:

  1. Creatinine clearance (CLcr) ≤ 30 mL/min according to the Cockcroft-Gault formula
  2. Alanine aminotransferase \> 5 x upper limit of normal (ULN)
  3. Direct bilirubin \> 1.5 x ULN
  4. Platelets \< 50,000/μL
  5. Hemoglobin \< 8.0 g/dL

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Purchasing Decisions and Food Consumption: Chile

Objective: To evaluate the effectiveness of taxes on unhealthy foods and subsidies for healthy foods in modifying the purchasing and consumption behavior of people in the Metropolitan Region, Chile.

Research hypothesis:

1. The application of a tax that increases the price of "High in" foods by 20% will reduce the purchase and consumption of these foods by 24%.
2. The application of a subsidy that reduces the price of fruits and vegetables by 20% will increase the purchase and consumption of these foods by 17%.
3. People of lower socioeconomic status are more sensitive to price changes than people of higher socioeconomic status.

Methodological design. The research proposal proposes an experimental design that will select the participants from a panel composed of people over 18 years of age, men and women, and of all socioeconomic levels. The methodological design considers a random assignment of the people eligible for the study into 3 groups:

1. First group of intervention (GI1): people who will make their purchases with taxes on food and beverages "High in";
2. Second intervention group (GI2): people who will make their purchases with subsidies for fruits and vegetables;

4. Control group (CG) that will make the purchases with the market prices or currently applied by the supermarkets or purchase scenarios.

Methodology. Participants will make a monthly simulated purchase through a simulated supermarket system with products similar to those found in real supermarkets, including "High in" products and fruits and vegetables. Different prices will be applied to each group depending on the type of food. With the data of simulated purchases, a variation of the demand and by socioeconomic subgroup will be calculated. The results will be compared with the control group.

Expected results. GI1 participants are expected to modify their purchase intention with the "High in" food tax, decreasing the purchase of these products in their simulated purchases, compared to CG participants who will make their simulated purchases without taxes. Likewise, IG2 participants are expected to modify their purchase intention with the fruit and vegetable subsidy, increasing the purchase of these foods, compared to CG participants. Finally, it is assumed that the reduction in simulated purchases of "High in" foods and the increase in simulated purchases of fruits and vegetables vary according to socioeconomic level.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age.
* Person responsible for household purchases.
* Living in a household with one or more boys or girls between 2-14 years of age

Exclusion Criteria:

* That in the home there are no dietary restrictions that prevent the development of this research such as eating disorders, food allergies
Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children

The aim of the study is to investigate the absorption and clinical effect of nasal administration of an analgesic nasal spray containing sufentanil+ketamine for pain related to medical procedures in hospitalized children.

The management of procedural pain in children ranges from physical restraint to pharmacological interventions. Pediatric formulations that permit accurate dosing, are accepted by children and a have a rapid onset of analgesia are lacking. The objectives were to investigate a pediatric formulation of intranasal sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg for procedural pain and to characterize the pharmacokinetic (PK) profile. Fifty children (≥10 kg) scheduled for a painful procedure were included in this prospective nonrandomized open-label clinical trial. Thirteen of these children had central venous access for drug assay sampling; enabling a compartmental PK analysis using nonlinear mixed-effects models. Pain intensity before and during the procedure was measured using age-appropriate pain scales. Heart rate, oxygen saturation and sedation were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents treated at the University Hospital, Rigshospital
* Painful medical procedure related to the patients treatment
* Patient and/or the parents must be able to understand and speak danish
* Negative pregnancy test for girls, when relevant
* Signed informed consent
* Only a light meals or no meals have been ingested 2 hours prior to inclusion

Exclusion Criteria:

* Allergy to sufentanil or ketamine
* Abnormal nasal cavity
* Have been treated with sufentanil and/or ketamine during the last 48 hours
* Nasal obstruction (rhinitis)
Patient Safety Skills for Medical Students

In this project, the authors aim to evaluate the use of high fidelity simulation as a method of evaluation of general skills in fifth year medical students about patient quality and safety in a hospital setting.

Undergraduate training in patient safety and healthcare quality is often overlooked by medical curricula.

Simulation techniques have been used in different subjects as a support for learning invasive techniques in surgical areas, but it has not been used to improve knowledge and performance on patient quality domains that would be applied in real life scenarios.

This project is a randomized trial for medical students undertaking the course in "Quality and Patient Safety". The authors will randomized students at the beginning of each rotation into two groups: a) an intervention group (where students will take the simulation and will be evaluated by a final written exam); and b) a control group (where students will take only the usual teaching in classrooms and will be evaluated with the same written exam). Furthermore, students will be asked to fill a questionnaire to obtain their attitudes and knowledge about the topics in quality and safety in healthcare.

Eligibility Criteria:
Inclusion Criteria:

* 5th year medical students enrolled in the course "Quality and Patient Safety" in the Tecnológico de Monterrey School of Medicine, Campus Monterrey.
Melatonin for Pulmonary Hypertension in Full Term Neonates

Published evidence has provided a possible role of melatonin and the treatment of pulmonary hypertension through its strong antioxidant properties and improving vascular function in animals.

This study will test the hypothesis of the possible use of melatonin as an adjunct therapy to milrinone for neonatal pulmonary hypertension.

Normal pulmonary artery pressure shows a gradual declining trend after birth, and pulmonary artery pressure of 72 h after birth is still higher than that of normal adults Infants born after 34 weeks of gestation with primary findings on physical examination reveals tachypnoea, retractions, grunting, desaturation unresponsive to supplemental O2, cyanosis and pulmonary arterial pressure (PAP) \> 25 mm Hg measured by echocardiography, within 72 h of birth, are considered to have pulmonary hypertension Pulmonary hypertension in neonates (PPHN) is a syndrome characterized by failure in the mechanisms that decrease pulmonary vascular resistance (PVR) and pulmonary arterial pressure (PAP) after birth Persistent pulmonary hypertension of newborn (PPHN) develops when pulmonary vascular resistance (PVR) remains elevated after birth, resulting in right-to-left shunting of blood through fetal circulatory pathways. The PVR may remain elevated due to pulmonary hypoplasia, like that seen with congenital diaphragmatic hernia, and maladaptation of the pulmonary vascular bed as occurs with perinatal asphyxia It has been shown that one of the mechanisms involved in the pathophysiology of PPHN is oxidative stress, which results in an imbalance between an increase in free radicals generation and decreased antioxidant capacity Currently, the treatment for PHN considers timely and precise interventions such as intravenous milrinone, oral pulmonary vasodilators such as endothelin receptor antagonist, phosphodiesterase-5 inhibitors such as sildenafil, inhaled nitric oxideand are used both during acute and chronic phases of PPHN, controlled oxygen administration, and even extracorporeal membrane oxygenation.

However, these therapeutic strategies do not markedly reduce the mortality and the long-term neonatal outcomes remain poor Melatonin, more commonly known as the sleep hormone, has been highlighted by experimental evidence, to have significant effects as a direct scavenger of oxygen free radicals and induces antioxidant enzymatic It has been shown that melatonin has vasodilator properties and may modulate pro-oxidant sources in the neonatal lung which is proposed to treat PHN in the first days of neonatal life.

Eligibility Criteria:
Inclusion Criteria:

* full term neonates ≥37 weeks diagnosed with pulmonary hypertension, with Pulmonary arterial pressure (PAP) \> 25 mm Hg measured by echocardiography, within 72 h of birth (Chetan et al., 2022).

Exclusion Criteria:

* Neonates with major congenital anomalies like congenital heart diseases

  * NPO or any contraindications to oral intake
  * Neonates with suspected inborn error of metabolism
MAP to Health Pilot Study: A Physical Activity Intervention for Midlife Adults

The study has two aims: (1) to develop and examine the acceptability of the technological and theoretical frameworks of MAP to Health and (2) to determine whether MAP to Health is related to changes in theoretically identified mechanisms of behavior change (meaning salience, basic psychological needs satisfaction, and internal motivation). In an exploratory aim, the study will assess how the intervention and mechanisms of change are related to changes in physical activity. Participants will be adults in midlife (ages 40-64) who are insufficiently active, are interested in increasing physical activity, do not have contraindications to engaging in physical activity, and are patients in a large healthcare system in the Midwest.


Eligibility Criteria:
Inclusion Criteria:

* Midlife (ages 40-64 at enrollment)
* Able to read and understand English
* Insufficiently active (engaging in ≥10 and ≤90 min of physical activity/week)
* Intention to increase physical activity in the next 30 days
* Has consistent access to a phone with text-messaging capability

Exclusion Criteria:

* Greater than minimal risk to starting a physical activity program (Physical Activity Readiness Questionnaire score \> 0)
* Body Mass Index (BMI)≥ 40
* Currently pregnant
* Has opted out of research
* Diagnosis of metastatic cancer or cardiovascular disease
* Residing in a nursing home or long-term care facility
* Cognitive or psychiatric conditions that preclude completion of questionnaires, including dementia diagnosis
* Diagnosis of severe psychiatric disorder (e.g., Bipolar Disorder, Schizophrenia)
* Diagnosis of substance use disorder or AUDIT-C62 \>3 for women or \>4 for men
Influence of Abutment Shape on Peri-implant Marginal Bone Loss

A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla.

A study designed as a randomized controlled trial of parallel group design will be conducted at the Dental clinic of the University of Valencia to evaluate the influence of 2.5 mm high abutments with different shapes (commercially available high abutments vs high abutments with modified shape to imitate short abutments) on peri-implant bone loss around bone level implants with platform switching in partially edentulous patients that require a fixed rehabilitation supported by two implants in the posterior mandible or maxilla and in fixed rehabilitation supported by one implant in the anterior mandible or maxilla (from premolar to premolar).

Eligibility Criteria:
Inclusion Criteria:

* Any subject requiring two implants in the posterior mandible or maxilla, being at least 18 years old and able to sign an informed consent. Final patient inclusion will be made after flap elevation during the implant placement surgery to be able to confirm the presence of a vertical thickness ≥ 3mm of keratinized soft tissues.
* Bone volumes should allow the placement of implants at least 8 mm long (i.e, 10 mm bone height to the inferior alveolar nerve) and 4.2 mm wide (7 mm wide bone crest) without bone regeneration procedures.
* Patients will be grouped into: 1) non smokers; 2) light smokers (≤ 10 cigarettes/day); 3) heavy smokers (≥ 11 cigarettes/day)

Exclusion Criteria:

* Patients unable to commit to follow-up.
* General contraindications to implant surgery.
* Immuno-suppressed/immune-compromised patients.
* Patients irradiated in the head and/or neck.
* Uncontrolled diabetes.
* Pregnancy or lactation.
* Untreated periodontal disease.
* Poor oral hygiene and motivation.
* Addiction to alcohol or drugs.
* Psychiatric problems and/or unrealistic expectations.
* Patients with an acute infection (abscess) or suppuration in the site intended for implant placement.
* Patients treated or under treatment with intravenous amino-bisphosphonates.
* Patients referred only for implant placement if the follow-up cannot be done at the treatment center.
* Patients participating in other studies, if the present protocol could not be fully adhered to.