cyrilzakka/clinical-trials huggingface dataset:
The Biomarker Exploratory Study in Prospective Multicenter Observational Study of Atezolizumab Combination Therapy in Lung Cancer (J-TAIL-2)

This study is implemented in association with the study "J-TAIL-2" ; prospective multicenter observational study of atezolizumab in patients with unresectable, locally advanced or metastatic non-small cell lung cancer, UMIN study ID: UMIN000041263, to evaluate biomarkers for selection of appropriate patients in treatment with atezolizumab combination therapy.


Eligibility Criteria:
Inclusion Criteria:

Inclusion/exclusion criteria of J-TAIL-2 study is to be applied.

\<non-small cell lung cancer cohort\>

1. Patients 20 years of age or older at the time of signed consent.
2. Patients with unresectable, advanced and recurrent non-small cell lung cancer.
3. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use Guideline.
4. Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments.

\<extensive disease small cell lung cancer cohort\>

1. Patients 20 years of age or older at the time of signed consent.
2. Patients with extensive disease small cell lung cancer.
3. Patients who are scheduled to start atezolizumab combination therapy in clinical practice, based on the atezolizumab package insert and the Optimal Clinical Use Guideline.
4. Patients who signed informed consent form before enrolling the study. The consent from a legally acceptable representative is required for the patients with uncertain capacity of judgments. However, the samples of dead cases can be used for the analysis of immune microenvironment of small cell lung cancer by disclosing information on this study.

Exclusion Criteria:

\<non-small cell lung cancer cohort\>

1. Patients who are unsuitable for enrolment into the study by the investigator's judgment.

\<extensive disease small cell lung cancer cohort\>

1. Patients who are unsuitable for enrolment into the study by the investigator's judgment.
Citrate Dialysate in Online Hemodialfiltration

Online hemodiafiltration (Ol-HDF) is increasingly being used for patients on chronic dialysis due to in its superiority compared with standard hemodialysis HDF. In addition to an excellent clearance of small molecules, oL-HDF has more advantages by providing both diffusion and convection modalities for an additional clearance of medium-size molecules. Furthermore, OL-HDF has been associated with not only better hemodynamic tolerance and biocompatibility , but may even include better survival.with reduction of proinflammatory cytokines and proinflammatory circulating cells , as well as with better control of B2MG levels .Ol-HDF is classified into 2 types according to the mode of addition of the substitution fluid: pre-dilution OL-HDF (pre-HDF) and post-dilution OL-HDF (post-HDF); Post-HDF was associated with significantly higher removal rates of β2-MG than HD. Postdilution HDF is the most effective way to maximize molecule clearance .Post-HDF was associated with significantly higher removal rate of α1-MG, and also significantly higher albumin leakage, than HD and pre-HDF. However, blood concentrations can be elevated using HDF, which can cause thrombosis. On the other hand, predilution HDF can resolve this problem but requires about three times more purified water than postdilution HDF and may not elicit maximal clearance.

Heparin is the most routinely used anticoagulant in hemodialysis. However, it exposes the patient to the risk of bleeding complications and can induce thrombocytopenia. Furthermore, long-term use of heparin induces biological and clinical complications (osteoporosis, dyslipidemia, hyperkalemia) . Regional citrate anticoagulation is a good alternative to heparin use in hemodialysis for patients with increased bleeding risk , but its implementation in bicarbonate hemodialysis (BHD) is laborious and cumbersome: severe side effects can occur due to citrate metabolism and difficulties in adaptation of calcium infusion into the venous line .Therefore, the use of citrate as a dialysis buffer instead of acetate has proven a safe alternative to acetate-containing bicarbonate dialysis and on-line hemodiafiltration without significant hypocalcemia or clinically important coagulation issues.The aim of the present study is the comparison of the patency of the dialyzer ,the quality of life and blood parameters between pre and potdiltuiotn Ol-HDF with citrate dialysate (CD). No study to date has previously compared the use of citrate dialysate between these two modalities in oL-HDF.

Eligibility Criteria:
Inclusion Criteria:

* Stable condition
* Having been under HD for at least three months
* he vascular access should have blood flow ≥ 300 mL/min.

Exclusion Criteria:

* no heparin use during HD
* refusal to participate,
* intolerance or allergy to citrate
* concurrent infection
* poor life expectancy due to metastatic cancer, severe cirrhosis and AIDS.
* patients vascular access modification,
* patients affected by chronic liver disease, active neoplastic or inflammatory disease were excluded as well as patients receiving immunosuppressive or anti-inflammatory drugs.
Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients

The aim of this intervention study is to compare the effect of topical Rebamipide (regular and nanoparticulated) to topical Clobetasol propionate in management of Methotrexate induced oral mucositis in patients with rheumatoid arthritis.

A random sample of patients diagnosed with rheumatoid arthritis attending at the Rheumatology clinic in faculty of Medicine, Cairo University Hospital, will be enrolled by the investigator in the study in a consecutive order after being examined for methotrexate induced oral ulceration by means of history and clinical examination.

Since oral mucositis associated with Methotrexate include production of free radicals, increase of inflammatory cytokines, and alteration of intracellular signal transduction, this suggests that Rebamipide should be useful for its treatment and prevention. Thus, this RCT will be the first to evaluate the treatment of Methotrexate-induced oral mucositis using Rebamipide and Rebamipide nanoparticles in patients with rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Patient who agreed to sign the informed consent.
* Age: 20-70 years old.
* Gender: males and females
* RA patients treated with MTX and suffering from MTX-induced oral ulceration.

Exclusion Criteria:

* Patients refused to sign the informed consent.
* Pregnant or lactating females in their child bearing age group.
* patients with known or suspected history of hypersensitivity to any of the ingredients of the preparation of the drugs used.
* Systemic disease: such as uncontrolled diabetes mellitus, auto-immune diseases known to cause oral ulceration, renal or liver dysfunction or any other condition considered risky by the clinician.
* Patients treated with any medication for the condition at the time of setting.
* Salivary gland diseases.
* Malignancy.
Ketamine for Sedation in Severe Traumatic Brain Injury

This protocol is for an open-label randomized trial evaluating the safety of using ketamine in combination with propofol for sedation versus the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury.

Patients meeting eligibility criteria and consent having been obtained by LAR will undergo randomization to either the ketamine with propofol intervention arm or the standard of care control arm.

Patients enrolled in the intervention arm will receive propofol at a rate of 300 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) bolus of ketamine, for sustained ICP elevations over 22mHg for greater than 5 minutes not attributed to other causes (coughing etc.). In the control arm, patients will receive their institutional analgosedation protocol. The sedation protocols will be continued until removal of intracranial pressure monitoring.

This study will take place during the participant's hospital care. The clinical team will administer treatment using standard practices, including all safety precautions available. Side effects will be monitored closely and may decide to discontinue the subject's participation in the study should the subject's health or safety are at risk.

The research team will performed one outpatient follow-up after study intervention ends.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18-65 years of age
* Severe traumatic brain injury (TBI), with a Glasgow Coma Scale (GCS) ≤ 8, requiring intracranial monitoring
* Placement of intracranial pressure monitor
* Receiving treatment in an intensive care unit (ICU)

Exclusion Criteria:

* Significant cardiovascular disease with recent coronary intervention
* Pregnancy
* Prisoners
* Known allergy to ketamine or propofol
Effects of Imagery and Breathing Exercises on Swimmers' Performance, Mental Toughness, and Heart-Mind Coherence

This randomized controlled trial aimed to investigate the effects of a 10-week imagery and breathing exercise intervention on 200-meter freestyle swimming performance, mental toughness, and heart-mind coherence in swimmers. Nineteen licensed swimmers aged 13-18 years were randomly assigned to an experimental group (n=9) receiving imagery and breathing exercises or a control group (n=10) receiving only standard physical training. Outcomes were measured using the 200-meter freestyle swimming time, the Sports Mental Toughness Questionnaire (SMTQ), and heart-mind coherence via the Inner Balance HeartMath device. The intervention significantly improved mental toughness and swimming performance in the experimental group compared to the control group, with a trend toward improved heart-mind coherence.

The study was conducted at the facilities of Pamukkale Üniversitesi Mensupları Spor Kulübü Yüzme Takımı in Denizli, Türkiye. Participants underwent a pre-test/post-test design with the following measures: 200-meter freestyle swimming performance, mental toughness (assessed via the Sports Mental Toughness Questionnaire), and heart-mind coherence (measured using the Inner Balance HeartMath device for real-time biofeedback of heart rate variability \[HRV\]). The experimental group participated in a 10-week intervention involving daily imagery and breathing exercises performed before bedtime, following a structured protocol (4-second inhale through the nose, 4-second exhale through the mouth, while imagining a 200-meter swim with detailed visualization). The intervention included a 6-day training period on techniques, followed by 10 weeks of daily practice, with reminders and feedback provided via a WhatsApp group. The control group continued standard physical training without additional mental training. Data were analyzed using a two-way repeated measures ANOVA, with post-hoc Bonferroni tests, and a significance level of p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Aged 13-18 years.
* Licensed and actively engaged in competitive swimming.
* No serious injuries in the past 6 months.
* Parental consent obtained for participants under 18 years.

Exclusion Criteria:

* Diagnosis of heart disease or respiratory system disorders.
* Psychiatric diagnosis or ongoing psychological treatment.
* Serious injury or surgery within the past 6 months.
Hypercortisolism and Epicardial Adipose Tissue

Identifying hypercortisolism patients at risk for cardio-vascular events despite biological cure, and determine which patients should be particularly followed. Hypercortisolic patients represent an ideal in vivo model to determine the interactions between glucocorticoids and ectopic fat development.


Eligibility Criteria:
Inclusion Criteria:

* Major, male or female
* Introducing an active or healed hypercortisolism caused by Cushing's disease
* signed informed consent.

Exclusion Criteria:

* Elderly patients under 18 years
* Pregnant or lactating women
* Previous history of myocardial infarction
* Antecedent congenital cardiomyopathy
* Adrenocorticotropic hormone-independent Hyperadrenocorticism
* Hyperadrenocorticism by ectopic Adrenocorticotropic hormone secretion
* Treatment with corticosteroids or insulin
* Specific contraindication to the achievement of Nuclear Magnetic Resonance (metal heart valves, pacemakers, metallic foreign body, claustrophobia)
* Persons deprived of liberty
* Persons not affiliated to a social security scheme
* People unable to give their consent in writing (in person or with the assistance of a third party).
Health-related Quality of Life in Rare Kidney Stone

Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium

The purpose of this study is to learn about Health-related Quality Of Life (HRQoL) in patients enrolled in the Rare Kidney Stone Consortium (RKSC) registries. Quality of life studies look at different aspects of both physical and mental components of people's lives. HRQoL data for people affected by kidney stones are not currently available for people followed over time.

Eligibility Criteria:
Inclusion Criteria:

* Qualify to participate in one of the Rare Kidney Stone Registries.
* Be at least 5 years old (for SF-10)
* Are able to communicate using the English language
* Consent to participate in the study (or "assent" if under 18 years old)
* Have internet access with an email account or a valid home address

Exclusion Criteria:

None, if inclusion criteria are met
Performance of RPA-LF for Cutaneous Leishmaniasis

CL is public health in the Americas, diagnostic confirmation is required to start treatment, however current diagnostic methods have several limitations and its access is limited.

Technical requirements of conventional molecular diagnostics and costs preclude their routine use in primary care facilities in rural areas. A recently developed method of Isothermal Recombinase Polymerase Amplification (RPA) targeting Leishmania kinetoplast DNA, has shown high accuracy in detecting Leishmania Viannia spp. We evaluated the diagnostic performance of the RPA-LF test in a laboratory reference center and field scenario with community participation.

CL is public health in the Americas with an average of 55,000 cases per year between 2001 - 2018 in 17 countries, which mainly occur in rural areas with an average of 55,000 cases per year between 2001 - 2018 in 17 countries. Diagnostic confirmation is required to start treatment, however current diagnostic methods have several limitations, and sometimes it is necessary to perform confirmatory tests that are not available in endemic areas.

Several molecular diagnostic tests have been developed for the diagnosis of CL, however, the technical requirements and costs of sample processing by conventional or quantitative PCR preclude their routine use in primary care facilities in resource-constrained settings. A recently developed method of Isothermal Recombinase Polymerase Amplification (RPA) targeting Leishmania kinetoplast DNA, coupled with lateral flow (LF) immunochromatographic strip has shown high accuracy in detecting Leishmania Viannia spp. We evaluated the diagnostic performance of RPA-LF test in two scenarios: laboratory reference center and field with community participation.

Eligibility Criteria:
Inclusion Criteria:

* Men or women with 2 years of age and over of any ethnic group
* Ulcerated skin lesions compatible with cutaneous leishmaniasis with two or more weeks of duration
* Approval of informed consent

Exclusion Criteria:

* Mucosal leishmaniasis
* Clinical presentations of cutaneous leishmaniasis different of ulcerated lesions
Tanglewood Trail Walking Program in Rural Kentucky 2020

The Tanglewood Trail Walking Program is a well established community health initiative that encourages community members to walk approximately 1 mile to the Whitesburg Farmers Market each Saturday. The study aims to determine if walking to the market with a community health coach results in healthier options being selected at the market when compared to the driving group.

In the summer of 2017, community members of Whitesburg, KY were recruited to join the Tanglewood Trail Walking Program to the Whitesburg farmers market. Each Saturday, participants reported whether or not they walked the 1 mile trail to the farmers market and they reported which fruits and vegetables they purchased. Participants completed questionnaires about fruit and vegetable consumption and physical activity. Participants also provided physical and biological measurements. The ClinicalTrials.gov record for the original trial in 2017 is NCT03495648.

Eligibility Criteria:
Inclusion Criteria:

* ability to walk 1 kilometer

Exclusion Criteria:

* pregnant
* institutionalized adults
* impaired consent ability
* prisoners
Effectiveness of Mobile Phone-Based Intervention to Prevent Smoking Relapse Among Recent Smoking Quitters

Main Objective The main objective of the study is to investigate the effectiveness of a mobile phone-based intervention in reducing relapse ate among recent quitters who are attending the smoking cessation program in Jazan.

Besides this, the study will achieve the following objective:

To identify the timing and different factors associated with relapse process among recent quitters during first 6 months of quitting.

Background:

Smoking remains a major public health problem and an important cause of morbidity and mortality worldwide. Although the effectiveness of behavior support and medical treatment, many of those who quit smoking subsequently relapse to smoke.

Objective:

The primary aim of this study will be to determine the effectiveness of the mobile phone-based intervention to prevent relapse among recent smoking quitters. Also, the study aims to identify the different factors associated with relapse among recent quitters during the first 6 months of quitting.

Design and Methods:

A parallel two-armed Randomized Controlled Trial (RCT) to assess the effectiveness of a mobile phone-based intervention for smoking cessation on achieving long term abstinence, will be conducted among volunteers. Participants will be recruited from those attended smoking cessation program in Southern Alrawdha clinic, Southern Abo Arish clinic, Sabia clinic and Aldhabia clinic.

Primary outcome:

The difference in relapsing rate among recent quitters, which may subsequently contribute in to a reduction in smoking rates.

Trail Implications for public Health:

The result of this study will provide evidence for effectiveness of the mobile phone-based intervention versus standard treatment to reduce smoking relapse rate. If proven, it will be a cost-saving intervention by reducing repeat use of the smoking cessation clinic services and by reducing use of healthcare services for smoking-related illness.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older.
* Recent quitters (24 hours smoking abstinence)
* Willing to provide informed consent to participate in the study.

Exclusion Criteria:

* Those suffering any physical or mental disorders.
* Illiterate people.
* Pregnant.
To Increase Psychological Well-being by the Implementation of Forgiveness Education

This project examines the development of psychological well-being in children and teachers through a 12- week forgiveness education program conducted in three conflict zones of the world, Northern Ireland, Israel/Palestine, and Taiwan.

A 12-week forgiveness education program will be investigated in elementary schools in three conflict zones of the world, Northern Ireland, Israel/Palestine, and Taiwan. The responsibilities of the sub-team in each of the three research sites will be:

* a. recruiting schools, assisting the teacher training before the forgiveness education program starts
* b. shepherding teachers, doing the fidelity checks, administering the instruments and collecting data during the forgiveness education program.

Once a school gives permission to be part of this study, the forgiveness curriculum will be implemented as a 12-week standard curriculum for the grade 5 (US equivalency) students. Teachers of the grade 5 classes will be trained to administer the program. Teachers, students and their parents must give the consent to take part in the measures of the study.

Classrooms participating in this study will be randomly assigned to either an experimental or a control group. The experimental group will receive the 1st forgiveness intervention for 12 weeks and then the control group will turn into an experimental group to receive a 2nd forgiveness intervention for 12 weeks.

In order to assess if such education increases psychological well-being in students (children) and teachers (adults), teachers and students in both groups will receive the same measures for four times in the study: within one week before the 1st forgiveness intervention, within one week after the 1st forgiveness intervention, within one week after the 2nd forgiveness intervention, four weeks after the 2nd forgiveness intervention.

The instruments include: for teachers, the assessment data will consist of the Enright Forgiveness Inventory Short Form (EFI-30), the Patient-Reported Outcomes Measurement Information System (PROMIS): Anger, Anxiety, and Depression scales, the Ethnic Prejudice Scale, the Herth Hope Index, the Rosenberg Self-Esteem Scale, a Classroom Cooperation scale, and a Cross-Cultural Exit Interview (written questionnaire). For students, the assessment data will consist of the Enright Forgiveness Inventory for Children (EFI-C), the PROMIS measures for pediatric self-report (ages 8-17): Anger, Anxiety, and Depressive Symptoms scales, the Ethnic Prejudice Scale for children, the Children's Hope Scale, the Coopersmith Self-Esteem Inventory (School Form), and academic achievement (likely to be scores/grades of Math, writing and reading in their own language). After the 2nd forgiveness intervention, select participants (teachers and children) will take part in individual interviews.

Eligibility Criteria:
Inclusion Criteria:

* Students in 5th grade (US equivalency, aged 10-12)
* Teachers in 5th grade (US equivalency)

Exclusion Criteria:

* Students who are in grades other than 5th grade
* Teachers who are in grades other than 5th grade
Cognitive-Behavioral Therapy (CBT) in Children With Diabetes

Diabetes mellitus in children and adolescents is a source of stress and poor quality of life for themselves and their family. Development of adaptive coping strategies may be improved by focused parent and children training. This study assesses a cognitive behavioral treatment (CBT) for children/adolescents with diabetes and their parents in comparison with standard health educational interventions. The investigators main aim is to verify that the CBT program improves overall balance of glycaemia better than phone contact without CBT content (control group). Secondary objectives are expected improvements of health-related quality of life and coping styles in parents and children.


Eligibility Criteria:
Inclusion Criteria:

* Children and teenagers from 6 years-old to 18 years-old
* Having diabetes treated by insulin for at least 1 year
* Followed in pediatric diabetology department of Arnaud de Villeneuve Hospital in University Hospital of Montpellier
* Study Inform Consent signed by both children and parents

Exclusion Criteria:

* Children with developmental delay, severe mental disorders or language delay
* Non French-speaking family
* Children who does not live with at least one of his/her parents
* Children whose residence is not compatible with frequent visits at University Hospital of Montpellier
* Clinical status not compatible with study questionnaires assessment.