cyrilzakka/clinical-trials huggingface dataset:
Use of Involvement Matrix in Cerebral Palsy Into Spain and Brazil

Application of Involvement Matrix in young people with Cerebral Palsy (GMFCS levels IV and V) from 12 to 17 years old with the purpose of improving the participation of this group in community leisure activities

The "Involvement Matrix" is a tool, which was built with organizations of patients, patients, parents, educators, doctors, and researchers, and supports the conversation and discussion about roles and expectations, aiming at authentic and sustainable alliances in research. It includes five participation roles: Listener, Co-thinker, Advisor, Partner and Decision-maker in three main phases of the research project: Preparation, Execution, and Implementation. The Involvement Matrix aims to be a guide for the project leader or researcher to dialogue with patients (public). Using the Matrix, agreements are made about the roles that the patient wishes to acquire and how they are involved in each phase. In this way, the empty cells in the Matrix are filled with specific activities.

Using the Involvement Matrix before and during the different phases of a project has the potential to help researchers and patients reach clear agreements about research and their participation. The tool can be used prospectively, to discuss the possible roles of patients in the different phases of the projects, and retrospectively to discuss whether the roles have been satisfactorily performed. It is known that some studies with PPI had children and young people with the most severe disabilities as active participants and with non-verbal communication, thus, the most effective ways to collaborate with this group should be developed and enhanced to encourage their involvement in research. Although periodicals on the PPI are increasing rapidly, a solid evidence base of the impact of the PPI on research is still lacking, as many publications relate to the PPI process in general and without addressing the real impact of the PPI on the research.

In this sense, the goal of this project is "to develop (co-production) an intervention program for young people with Cerebral Palsy (GMFCS levels IV and V) from 12 to 17 years old with the purpose of improving the participation of this group in community leisure activities and assess the viability of public involvement in the research project through the use of the Involvement Matrix ".

Eligibility Criteria:
Inclusion Criteria:

* young people diagnosed with Cerebral Palsy (CP) from 12 to 17 years old, levels IV-V within the Gross Motor Function Classification System (GMFCS)
* preserved cognitive status
* families willing to cooperate with the research, as well as the physiotherapists and occupational therapists that accept to participate in the study.

Exclusion Criteria:

* young people with an inadequate cognitive level (CI \<70) to answer questions and collaborate, with other problems or diseases not associated with CP
* non-cooperative families, and physiotherapists and occupational therapists who do not agree to sign the informed consent form for inclusion in the study
SNAGs in Mechanical Neck Pain

Neck pain is second largest cause of disability worldwide. Chronic neck pain prevalence is 14% which is somewhat higher in females as compared to males. In India reported prevalence is 6%. Therapeutically, neck pain is managed by physiotherapists using rest, stretching and strengthening exercises, educating patient, and intense proprioception and positional exercises.

To determine the evidences for the efficacy of SNAGs in the Management of Mechanical Neck Pain.

100 patients \[Age group 25-45 yrs\] who were diagnosed with neck pain, with onset ˃1-3 months (chronic) were randomly assigned to group A receiving conventional Physiotherapy plus SNAGs and group B receiving conventional Physiotherapy plus ultrasound.

Subjects in-group A that received conventional Physiotherapy plus SNAGs showed greater Improvement in pain and range of motion compared with the conventional Physiotherapy plus ultrasound group on 2nd week compared with pretreatment.

The result of study suggests that both SNAGs and Ultrasound groups improves the symptoms of neck pain. Ultrasound group improved the pain symptoms but was too small to reach satisfactory outcome for patients. Based on these results conventional Physiotherapy plus SNAGs should be the treatment of choice for neck pain rather than conventional Physiotherapy plus Ultrasound .

Eligibility Criteria:
Inclusion criteria

* Age group between 20- 45 years.
* Both Gender male and female.
* Individuals having localized pain or stiffness in spine or both combined b/w C3 to C7 without upper limbs radiculopathy.
* Pain reported on VAS score ˃3 in neck region.
* Patients agree to sign written consent form.

Exclusion Criteria Patients were excluded if they were diagnosed with following conditions for ˃6 months:

* T.B, carcinoma, heart disease, osteoporosis.
* Neural disorders due to PIVD.
* Any trauma or localized infection in neck region.
* Upper MND, cervical stenosis, metabolic diseases in bone and joint.
* Hyper flexibility
* Open sores,
* Ongoing radiotherapy, chemotherapy, steroid therapy or anticoagulants.
* Psychiatric diseases such as phobia/obsession, depression.
* Allergy to hot pack
* Patients with history of surgery in cervical spine region with in a year.
E-learning on the Trainees' Ability to Diagnose and Treat Acute Otitis Media Among Children

An e-learning module to teach how to evaluate ears in children was recently designed. The aim of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose ear infection in clinical setting.

Background and aims: Acute Otitis Media (AOM) is one of the most common infections of childhood and a leading cause for antibiotics prescription. In a previous study performed at a tertiary care pediatric emergency department, residents were found to have as low as a 52% sensitivity and 74% specificity for the diagnosis of AOM. Seeing this as an opportunity for substantial improvement, an e-learning module on AOM intended for medical students was designed. The primary objective of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose AOM. The secondary objectives are to assess the preferred learning modality, to evaluate if our e-learning module is associated with improved knowledge on AOM and with better retention at 3 weeks.

Methods: This will be a randomized trial performed at a single tertiary care pediatric emergency department. The participants will be third- and fourth-year medical students doing a general pediatrics rotation. The participants will be randomized to completing the e-learning module at the beginning of their rotation or to receive a 2-hour lecture on the topic of AOM. The primary outcome will be ear examination accuracy measured during their shifts at the emergency department. To measure this, participants will be asked to examine a minimum of five children at risk for AOM, defined as 12-60 months old of age with fever or respiratory symptoms. They will be questioned about the presence or absence of AOM in each examined ear. Attending physicians will control all exams and write down their diagnosis. The primary analysis will be the difference in diagnostic accuracies between the trainees who completed the E-learning module and those who received the lecture. A sample size of 80 medical students each examining a minimum of five children would provide a power of 90% and an alpha-value of 0,05 to demonstrate a difference of 15% in the AOM diagnostic accuracies of medical students who have completed an E-learning module on AOM compared with those receiving a standard lecture on the same topic.

Eligibility Criteria:
Inclusion Criteria:

* Third or fourth-year medical students
* Doing their 6-week rotation in general pediatrics at Sainte-Justine Hospital
* Participation at the introductory meeting on the first day of the rotation

Exclusion Criteria:

* No shifts scheduled at the emergency department during general pediatrics rotation
* Student already recruited in a previous rotation
* Student who evaluated less than 10 ears for the study will not be included in the primary analysis
Oxygenation by 100% Oxygen Via High Flow Nasal Cannula in Surgical Patients

Oxygenation with high-flow nasal cannula with 100% oxygen has only been evaluated in a limited number of studies. Although data are convincing it is of importance to evaluate this new concept in our department before implementing it into clinical practice.

The general purpose of this project is to evaluate a new ventilation strategy during ENT-surgery based on oxygenation with high-flow nasal cannula with 100% oxygen with focus on gas exchange.


Eligibility Criteria:
Inclusion Criteria:

1. Adult, \>18 years old
2. ENT-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery) and the anesthesia time is \<40 mins.
3. Capable of understanding the study information and sign the written consent.

Exclusion Criteria:

1. ASA\>2
2. NYHA \>2
3. BMI \>30
4. Pregnancy
5. Manifest cardiac failure or coronary disease
6. Neuromuscular disease
Reveal the Level of Anxiety in Patients With Crohn's Disease Receiving Adalimumab

It has been shown that emotional health issues, such as state anxiety, are more prevalent in patients suffering from inflammatory bowel disease (IBD) compared to physically healthy subjects.

Such findings have to be taken into consideration when making an educated guess that psychological factors such as depression and anxiety in particular interact with the course of Crohns disease. Therefore the treatment of the underlying disease may have a significant influence on the level of psychological disorders.

Several studies have shown that treatment with tumor necrosis factor alpha (TNF-α) antibodies ameliorates the emotional/psychological status of patients, however the impact of adalimumab therapy on anxiety correlated with the status of inflammatory bowel disease (IBD) remains unclear.

The primary objective of this study was to describe and evaluate changes in levels of anxiety assessed by validated patient questionnaires after 6 months of treatment with adalimumab.


Eligibility Criteria:
Inclusion Criteria:

* Patients for whom Adalimumab (Humira) therapy is indicated and has been prescribed according to the product label and who meet the following criteria:

  * Male and female patients aged 18 to 65 years suffering from severe active Crohns Disease, attending a routine medical visit.
  * Able to complete questionnaires.
  * Patients with status active severe Crohns disease which required immunosuppressive treatment
  * Patients must fulfil international and national guidelines for the use of a biologic therapies in Crohns Disease (Chest X-ray and interferon gamma release assay (IGRA) or PPD (purified protein derivative)-skin test negative for tuberculosis).
  * Patients have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
  * Patients who have been prescribed in line with the European Summary of Product Characteristics (SMPC)

Exclusion Criteria:

* The following patients will not be included in this observational study:

  * Previous therapy with TNF-α blocker within the last 8 weeks
  * Active Central Nervous System opportunistic infections or Central Nervous System malignancies.
  * History of Cerebrovascular Accident
  * Abuse of illicit substances (such as psychoactive drugs) within the previous 3 months
  * Change of medication-based treatment of generalized anxiety and panic disorder, psychiatric disorder
  * No informed consent
  * Contraindication to adalimumab (Humira) therapy according to the SMPC
  * Current or planned pregnancy
  * Lactation according to SMPC
  * Planned change of site within the next 24 weeks.
Study of HL-085 and Vemurafinib in Metastatic Colorectal Cancer (mCRC)

The study consists of the two parts, phase IIa and phase IIb.

The study consists of the two parts, phase IIa and phase IIb. Phase IIa study is to assess the safety and the antitumor activity in patients with mCRC and to recommend reasonable dosage regimen of HL-085 for phase IIb study. Phase IIb is a pivotal study to evaluate HL-085 plus Vemurafenib in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting.

Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent prior to enrollment；
* Adults 18 years of age or older, male or female;
* Histologically- or cytologically-confirmed CRC that is metastatic disease, and a) progression of disease or intolerance after line 1 or line 2 therapy，or inappropriate for line 1 therapy (for phase Ⅱa); b) progression of disease or intolerance after line 1 or line 2 therapy (for phase Ⅱb);
* Patient must have measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
* Life expectancy ≥ 3 months;
* Able to take the medicine orally;
* Adequate bone marrow and organ function.

Exclusion Criteria:

* Prior treatment with any RAS inhibitors, RAF inhibitors, or MEK inhibitors;
* History or screening evidence of retinal diseases;
* Impaired cardiovascular function or clinically significant cardiovascular and cerebrovascular diseases;
* Previous or current neuromuscular diseases that is associated with CK elevation (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy, rhabdomyolysis syndrome);
* Impaired liver function, defined as Child-Pugh Class B or C;
* Toxicity has not recovered to grade 0 or 1 from prior anticancer therapy (except for alopecia, pigmentation, and grade 2 chemotherapy-related neurotoxicity);
* Use of any medications or foods that are strong inhibitors or inducers of cytochrome P450 (CYP) 3A4/5 within 7 days prior to the start of study treatment or during the study period, , drugs with a narrow therapeutic window for CYP1A2 metabolism.
JK-1201I Combined with Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma Multiforme (GBM)

This study was designed to evaluate the safety, tolerability, efficacy and pharmacokinetics of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.

This is a multicenter, single arm, open-label, dose-escalation phase 2 study of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme (GBM) after surgery and concomitant radio-chemotherapy Patients will receive JK-1201I combined with temozolomide until disease progression.

The primary objective of this study is to assess the safety of JK-1201I combined with adjuvant temozolomide in patients with newly diagnosed glioblastoma multiforme after surgery and concomitant radio-chemotherapy.

The secondary objectives of the study are to further evaluate the efficacy and pharmacokinetic profiles of JK-1201I.

Eligibility Criteria:
Inclusion

Participants must meet all the following criteria to be eligible for randomization into the study:

1. Male or female aged ≥18 years and ≤75 years.
2. Patients newly diagnosed with glioblastoma either by imaging or pathology testing, Gross total resection equal to or greater than 80%.
3. Patients must finish concurrent chemo-radiotherapy (CCRT) no sooner than 4 weeks and no later than 6 weeks.
4. Stable dose or reduced dose of corticosteroid for more than 2 weeks.
5. Karnofsky score ≥ 70.
6. Life expectancy \&amp;gt; 12 weeks.
7. Adequate biological function.
8. Men or women should be using adequate contraceptive measures during the study and for 6 months following the last dose of investigational product.
9. Sign and date the informed consent form prior to the start of any study-specific qualification procedures.
10. MGMT unmethylation (only for Dose Expansion Cohort).

Exclusion

Participants who meet any of the following criteria will be disqualified from entering the study:

1. Patients who received anti-tumor therapy except for concurrent chemo-radiotherapy (CCRT).
2. Patient diagnosed with brain stem and spinal cord tumor as the primary tumor.
3. Hypersensitivity to any ingredient of JK-1201I.
4. Severe, uncontrolled or active cardiovascular diseases within the past 6 months.
5. Inability to take medication by oral or presence of clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.
6. Uncontrolled seizures.
7. Patient receiving prohibited medications and that cannot be discontinued at least 2 weeks prior to the start of treatment.
8. Severe or uncontrolled high blood pressure.
9. Unresolved toxicity from prior anti-tumor therapy.
10. Women who are pregnant or Breast-feeding. 11 Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or active hepatitis C virus infection.

12. Have participated in another clinical trial within 4 weeks prior to informed consent form.

13. History of mental disorders. 14. Other conditions that the investigator considers unsuitable to participate in this clinical trial.
PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders

The purpose of this observational study is to give an overview of the use of PASCOE-Agil HOM-Injektopas in a 2-4 week treatment of rheumatic disorders.

The purpose of this observational study is to give an overview of the use of PASCOE-Agil HOM-Injektopas in a 2-4 week treatment of rheumatic disorders of different aetiology and localisation, displaying a variety of symptoms.

Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management in relation to the Summary of Product Characteristics (SmPC).

Eligibility Criteria:
Due to the design as an Observational Study no inclusion or exclusion criteria for therapy are named. The included patient group is described under "Cohort / Group".

Observational Criteria (=inclusion criteria for documentation):

* Males and females
* At least 18 years old
* Rheumatic disease with accompanying symptoms, e.g. arthralgia, myalgia, lumbago etc.

Exclusion criteria for documentation:

* younger than 18 years
* no Rheumatic disease with accompanying symptoms, e.g. arthralgia, myalgia, lumbago etc.
* no treatment with PASCOE-Agil HOM-Injektopas
Establishment and Validation of a Predictive Model for the Risk of Colorectal Advanced Adenomas

The study aimed to analyze the risk factors of colorectal advanced adenoma and constructe a model to predict the high-risk individuals of harbouring colorectal advanced adenomas, so as to better identify screening participants and provide an important theoretical basis for the prevention of colorectal cancer.

A large cohort of eligible patients were included in the analysis, and classified into derivation and validation cohorts at a ratio of 7:3. Demographic and clinicopathological characteristics of participants were utilized to develop a prediction model for colorectal advanced polyps. In the derivation cohort, the LASSO regression method was applied to filter variables and multivariate logistic regression analysis was used to identify important predictors.A prediction model was established based on the results of multivariate logistic regression analysis. The predictive performance of the model was evaluated with respect to its discrimination, calibration and clinical usefulness.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 and ≤75 years old. Patients with complete data on demography and clinicopathology.

Exclusion Criteria:

* Patients with a history of inflammatory bowel disease, enterophthisis, familial adenomatous polyposis, P-J syndrome and intestinal lymphoma.

Patients with a previous history of colorectal neoplasm. Patients with a history of severe systemic diseases. Lack of complete clinical data for analysis.
Telemedical Algorithm-Supported Care for Hypertension

Hypertension is a major global health issue, affecting around 9 million people in Poland. While some studies indicate that telemonitoring benefits patients with hypertension, there is a lack of research evaluating tools that assist doctors in managing these patients. The objective of this study is to assess a blood pressure monitoring system with an integrated algorithm that aids doctors in the decision-making process.

The SOT-ART-HT study is a single-center, randomized, open-label trial aimed at comparing two strategies for managing arterial hypertension. Patients in the control group will receive standard care, which includes regular visits to a hypertension clinic, while those in the intervention group will receive remote care through a specialized tele-informatic system designed to assist the physician. The trial will involve 200 participants, aged 18-80, with confirmed arterial hypertension and uncontrolled office blood pressure at the screening visit. Both primary and secondary outcomes will be evaluated, with the study expected to be completed after 2026. However, early termination could occur if required by regulatory bodies, an Ethics Committee, or the Scientific Research Committee.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily signing an informed consent to participate in the study.
2. Age between 18 and 80 years.
3. Diagnosis of hypertension according to the Polish Society of Hypertension criteria from 2019, either already treated or newly diagnosed.
4. Blood pressure exceeding 140/90 mmHg in office measurements (during the screening visit).

Exclusion Criteria:

1. Suspicion or diagnosis of secondary hypertension.
2. Pregnant women, breastfeeding women, or those planning pregnancy during the study period.