cyrilzakka/clinical-trials huggingface dataset:
Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)

To investigate safety, tolerability of cafusertib combination with low dose cytarabine (LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for conventional or intensive treatment. The dose of cafusertib will be escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cafusertib in combination with LD-Ara-C in AML patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of cafusertib will be observed in AML patients. To determine the recommended dosage regimen for phase II.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent consistent with Chinese Good Clinical Practice.
* Male or female patients of age \>/= 18 years at the time of informed consent.
* Patients with relapsed/refractory AML ineligible for conventional or intensive treatment.
* Eastern Cooperative Oncology Group performance status score 0 - 2 at screening.
* Life expectancy of at least 3 months.
* Adequate hepatic, renal and metabolic function parameters: Serum total bilirubin ≤1.5 x upper limit of normal, aspartate transaminase (AST) , alanine transaminase (ALT) ≤2.5 x upper limit of normal; Creatinine clearance rate ≥60ml/min, Serum creatinine ≤1.0 x upper limit of normal; Relatively normal ECG(electrocardiogram), QTc\<450 ms(male) ,QTc\<470 ms(female); LVEF\>50%.
* Patients who can comply with the trial and follow-up procedures.

Exclusion Criteria:

* Patients had received cafusertib hydrochloride or other PLK inhibitors.
* Patients with APL.
* Patients with central nervous system leukemia.
* Need to continue using cytokine therapy at screening.
* Patients participated in other clinical trials within 4 weeks prior to enrollment.
* Patient with severe infection.
* Patients with myocardial infarction had occurred within six months prior to enrollment.
* Severe heart disease, including NYHA class II cardiac dysfunction and above.
* Patients with HIV infection or acute and chronic viral hepatitis.
* Severe gastrointestinal disorders (bleeding, infection, obstruction or greater than grade 1 diarrhea).
* A previous history of neurological or psychiatric disorders, including epilepsy or dementia.
* Concomitant medications with CYP3A4 inhibitors, inducers or substrates; Women pregnant or breast feeding.
* Subject is thought unfit for this study by investigator.
Ultrasound Guided Modified Pectoral Plane Block Versus Erector Spinae Plane Block During GA in Gynecomastia Surgery

Pain of breast surgery is due to chest wall scar and arm in some cases like carcinoma or due to nerve injury.It is neuropathic or nociceptive pain.Its severity is depending on the extent of surgery and the radiotherapy if needed.

Previous studies proved that local nerve block procedures improved the immediate postoperative pain and decreased the incidence of postoperative pain chronicity .

Also effective control of pain suppresses the surgical stress response minimizes the anaesthestic needs intraoperatively and decreases the opioid needs postoperatively .

Pectoralis nerve(pecs) II block and erector spinae plane (ESP) block are novel procedures that may provide good intraoperative and postoperative analgesia in patients undergoing surgical treatment of gynecomastia.


Eligibility Criteria:
Inclusion Criteria:

* Male gender .
* Age : 18 - 25 years old .
* Physical status : ASA I - II .
* Body mass index(BMI) :20-30 kg/m2
* Surgical treatment of Gynecomastia .
* Duration of surgery : 60 -120 min

Exclusion Criteria:

* Patient refusal .
* History of opioid abuse or chronic analgesic use .
* Coagulopathy .
* Allergy to study drugs .
* Infection in the injection sites.
* Uncooperative patients.
High Flow Nasal Cannula Compared to Standard Oxygen for Endoscopic Ultrasound

The purpose of the study is to evaluate the use of high flow nasal cannula versus standard oxygen therapy for high-risk patients undergoing endoscopy procedures.

Patients with a higher BMI are at greater risk for lower oxygen levels which can delay the endoscopy procedure. This research is being conducted to find out if high risk patients will have a shorter recovery time and improved procedural conditions with a high flow nasal cannula versus standard oxygen therapy.

Eligibility Criteria:
Inclusion Criteria:

• All patients age 18 years and older who present to Gonda 2 procedural area for Endoscopic ultrasound (EUS) with or without endoscopy (EGD)/biopsy/tissue sampling. with BMI ≥ 35 kg/m2 (BMI within the past 6 months in electronic medical records or at current procedure) who are able to consent will be approached for potential enrollment.

Exclusion Criteria:

* Need for general anesthesia for the procedure instead of the standard monitored anesthesia care.
* Patients undergoing combined procedure: Therapeutic EUS/combined procedures including EUS/ERCP, EUS/colonoscopy
* Patients on home oxygen therapy, or the diagnosis of "severe COPD"
* Patients with existing tracheostomy
* Inpatients undergoing EUS
* Inability to consent
* Cognitive impairment
* Blocked nasal passages
* Trauma/previous surgery to the nasopharynx
* Irregularities of the nose, face, or airway such that HFNC cannot be properly fitted
Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload.

The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.


Eligibility Criteria:
Inclusion Criteria:

* Patients with transfusional iron overload who have successfully completed the one year chelation treatment in the deferasirox trial or the food-effect sub-study and who were considered by the investigator eligible to continue chelation therapy with deferasirox

Exclusion Criteria:

* Pregnant or breast feeding patients
* Patients being considered by the investigator potentially unreliable and/or a history of non-compliance
Analysis of the Evolution of Mortality in an Intensive Care Unit

The intensive care units is of the main components of modern healthcare systems. Formally, its aim is to offer the critically ill health care fit to their needs; ensuring that this health care is appropriate, sustainable, ethical and respectful of their autonomy. Intensive medicine is a cross-sectional specialty that encompasses a broad spectrum of pathologies in their most severe condition, and specifically has as its foundation the practice of comprehensive care of the patient with organ dysfunction and susceptible to recovery. Although critically ill patients are a heterogeneous population, they have in common the need for a high level of care, often requiring the use of high technology, specific procedures for the support of organ dysfunction and the collaboration of other medical and surgical specialties for their management and treatment.

Since their origins in the late 1950s, intensive care units have been adapting to the changes arising from the best scientific evidence. In the late 1990s and early 2000s, there were some successful clinical trials published that had tested alternative management strategies in the ICU.

Mechanical ventilation is an intervention that defines the critical care specialty. Between 1970 and the 1990s, the management focused on normalizing arterial blood gas with aggressive mechanical ventilation. Over the ensuing decades, it became apparent that performing positive pressure ventilation worsened lung injury. The pivotal moment in the mechanical ventilation story would be the low versus high tidal volume trial. This trial shifted the focus away from normalizing gas exchange to reducing harm with mechanical ventilation. Further, it paved way for further trials testing ventilation interventions (PEEP strategy, prone position ventilation) and nonventilation interventions (neuromuscular blockade, corticosteroids, inhaled nitric oxide, extracorporeal gas exchange) in critically ill patients.

That evidence-based intensive care medicine has undoubtedly had an influence on the outcome of critically ill patients, in general, and, particularly, of patients requiring mechanical ventilation. Temporal changes in mortality over the time have been scarcely reported for patients admitted to intensive care unit.

Objective of this study is to estimate the changes over the time in several outcomes in the patients admitted to an 18-beds medical-surgical intensive care unit from 1991 (year of start of activity) to 2026


Eligibility Criteria:
Inclusion Criteria:

• Patients admitted to intensive care unit

Exclusion Criteria:

• None
Tolerability/Safety and Efficacy of Inhaled AZD4818 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is to see if treatment with AZD4818 for four weeks is tolerable, safe and effective in treating COPD and, if so, how it compares with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of COPD, with symptoms for more than 1 year
* Current or ex-smokers with a smoking history of at least 10 pack-years (1 pack-year=20 cigarettes/day for 1 year)
* Lung function (FEV1) 40 to 80% of the predicted normal value after using a short acting bronchodilator

Exclusion Criteria:

* Clinical suspicion of active tuberculosis
* Any current clinically significant respiratory tract disorder other than COPD
* History of current clinically relevant arrhythmia, heart block, ECG abnormalities, or unstable angina
BaSES Trial: Basel Starch Evaluation in Sepsis

Background: In patients with severe sepsis and septic shock early aggressive volume replacement reduced mortality. Standard infusion therapy consists of crystalloid infusions. The role of modern, low molecular weight, starch preparations and their influence on the course of disease is not determined yet.

Hypothesis: The purpose of this study is to determine wether initial infusion therapy with Hydroxyethylstarch and Ringer's lactate reduces in septic patients reduces Intensive Care Unit and hospital length of stay without impairment of renal function

Design: Double-blind, randomized, controlled monocentric study

Setting: Intensive Care Units of a University Hospital

Patients: 240 consecutive patients with sepsis, severe sepsis and septic shock

Intervention: Volume therapy with Ringer's lactate and saline or hydroxy-ethyl starch (MW 130, substitution 0.4) in the first five days of intensive care treatment.

Parameter:

* Intensive Care length of stay
* Hospital length of stay
* Mortality
* Kidney function

Statistics: Mann-Whitney test for non-parametric data like intensive care length of stay. Unpaired t-Test for kidney function parameters.

Study withdrawal: Significant impairment of kidney function parameters in the hydroxy-ethyl starch group


Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected or proven infection and 2 of the following 6 criteria:
* Body temperature \<36 or \>38.3° celsius
* Heart rate \> 90 beats/min
* Tachypnea \> 20/min or a arterial pCO2 below 4.25 kPa
* White blood cell count higher than 12.000 or below 4.000 or more than 10% immature forms
* Systolic blood pressure \<90 mmHg or mean arterial pressure \< 65 mmHg
* Altered mental state or oliguria

Exclusion Criteria:

* Pregnancy
* Age below 18
* Allergy against Hydroxyethyl starch
* Chronic renal insufficiency
Combined Effects of Motor Imagery and Core Stability Exercises in Stroke Patients

This research explores the combined effects of motor imagery and core stability exercises on trunk control, balance, and sleep quality in stroke recovery, addressing Pakistan's unique healthcare challenges. By enhancing neuroplasticity, core strength, and physical function, these interventions aim to improve mobility, independence, and overall quality of life for stroke survivors, while addressing common sleep disturbances.

Stroke patients can benefit from motor imagery and mirror therapy, which are easy to perform anytime and anywhere at their convenience. Integrating motor imagery training with task-specific training leads to greater improvements in sit-to-stand performance compared to task-specific training alone. Core exercises, whether performed alone or combined with other therapies, have been shown to influence trunk performance in stroke patients compared to traditional training. Patients who have had strokes can benefit from rehabilitation training that focuses on strengthening their core muscles. This is likely because it thickens the transverse abdominis muscle. Post-stroke patients were able to regain their motor function and sense of independence with the use of motor imagery as an additional resource. It has been shown to be an effective therapeutic strategy for this particular patient population. More than with routine physiotherapy, core stability exercises on both stable and unstable support surfaces improve ambulatory stroke patients' trunk control, core muscular strength, standing weight-bearing symmetry, and balance confidence. Combined action observation and motor imagery therapy may be helpful for neurorehabilitation in chronic stroke survivors when physical practice is not appropriate. Compared to standard physical treatment alone, core stability exercise and conventional physical therapy has demonstrated better outcomes in trunk control and balance.

The combination of motor imagery and core stability exercises remains underexplored in stroke rehabilitation, leaving a significant knowledge gap about their synergistic potential. Investigating their combined effects could offer innovative strategies to improve trunk control, balance, and sleep quality, paving the way for more comprehensive and effective post-stroke treatment programs.

Eligibility Criteria:
Inclusion Criteria: Adults aged 40-65 years.

* Diagnosed with stroke (ischemic or hemorrhagic) within the last 6 months to 2 years.
* Hemiplegic Patient
* Having MMSE score ≥ 24
* Experiencing balance impairments on BBS 21-40
* Having sleep disturbances on PSQI 15-21.
* Willing to provide informed consent.

Exclusion Criteria: Severe cognitive impairments (e.g., severe dementia).

* Other neurological or musculoskeletal conditions affecting balance.
* Severe cardiovascular or respiratory conditions contraindicating exercise.
* Participation in another clinical trial within the past 3 months.
Video-based Climate Change Program

Climate change represents a global crisis with far-reaching implications for health, including mental health. Among vulnerable populations, such as nursing students, climate change anxiety is emerging as a noteworthy concern. Recognizing the need to address this issue, our research aims to investigate the impact of a virtual-based program on climate change awareness, anxiety levels, and self-efficacy among nursing students. As future healthcare professionals, nursing students play a pivotal role in promoting sustainable health practices and addressing the health impacts of climate change. This study seeks to contribute valuable insights into the effectiveness of virtual interventions in raising awareness and enhancing the coping mechanisms of nursing students in the face of climate change challenges.

Aim:

to investigate the effect of a video-based climate change program on revitalizing eco-cognizance, emotional response, and self-efficacy among nursing students in rural communities when compared to a group who received flyers related to climate change across the globe.

Research Hypothesis

* Hypothesis 1: The video-based climate change program will significantly improve climate change perceptions among college students in rural communities.
* Hypothesis 2: The video-based climate change program will significantly improve environmental self-efficacy among college students in rural communities.
* Hypothesis 3: The video-based climate change program will significantly reduce climate change anxiety among college students in rural communities.

Eligibility Criteria:
Inclusion Criteria:

To be eligible for the study, students had to be from 2nd academic year to 4th year, not enter any educational program about climate change, owning a smartphone, and willingness to participate in program.

Exclusion Criteria:

* students who have psychological problems
An Investigational Scan (Ga-68 PSMA-11 PET/CT) for the Detection of Therapy Response in Patients With Metastatic Adenoid Cystic Carcinoma

This phase II trial tests whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful for detecting therapy response in patients with adenoid cystic carcinoma (salivary gland cancer) that has spread from where it first started (primary site) to other places in the body (metastatic). The PET scan detects and takes pictures of where the radioactive imaging agent (68Ga PSMA-11) has gone in the body and the CT scan uses x-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. This study may help researchers learn whether GA-68 PSMA-11 PET/CT is useful for detecting treatment response and guiding treatment decisions in patients with metastatic adenoid cystic carcinoma.

PRIMARY OBJECTIVES:

I. Evaluate the feasibility of serial Ga-68 PSMA PET/CT for response assessment in metastatic adenoid cystic carcinoma.

II. Assess the correlation of PSMA PET/CT response assessment with serum extracellular vesical (EV) PSMA levels for patients undergoing treatment for metastatic adenoid cystic carcinoma.

OUTLINE:

Patients receive Ga-68 PSMA-11 intravenously (IV) and then undergo PET/CT 50-70 minutes after injection at baseline and approximately 12-20 weeks during investigational therapy.

After completion of study intervention, patients are followed up at 1 day.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Diagnosis of metastatic adenoid cystic carcinoma
* Enrolled in protocol MC200708
* Ability to tolerate a Ga68 PSMA PET/CT imaging study
* Willingness to return for a second PSMA PET/CT scan in approximately 12-20 weeks from the baseline PET/CT
* Ability to give appropriate consent or have an appropriate representative available to do so

Exclusion Criteria:

* Unable to undergo PET/CT scan
* Not a participant in MC200708
* \< 18 years of age
* Persons who are pregnant or nursing
* Persons unable to consent to the study
Effects of Dual-task Exercises on Gait Parameters and Cognitive Function in Elderly Women: A Randomized Controlled Trial

The training of a secondary task while walking, whether it is reasoning activities, memory or motor tasks, may enhance automation, walking performance, and postural control and, thus, minimize the risk of falls influenced by the walking patterns variability. However, the literature is scarce regarding the influence of dual-task training on changes in gait parameters.

The purpose of this prospective, blinded randomized controlled trial is to compare the short- and long-term effects of dual-task and aerobic training on gait stride variability and superior cerebral functions of independent community-dwelling elderly women.

The participants will be randomly allocated into either experimental or control groups.The experimental group will undertake 50 minutes/day of dual-task training, three times/week over 12 weeks, totaling 36 sessions, whereas the control group will receive the same doses of aerobic training. At baseline, after 18 and 36 sessions, and 12 weeks after the cessation of the interventions, researchers blinded to group allocations will collect the outcome measures.The interventions will be delivered by trained physical therapists.

Primary outcome will include gait stride variability, which will be assessed by a movement analysis system: the GaitRite® system, during cognitive and motor dual-tasks, at both normal and fast speeds. Secondary outcome measures will include a battery of global and specific cognitive function tests.

The findings of this trial may help better understand whether cognitive-motor interventions with older adults, when compared to traditional aerobic training, would result in greater improvements in gait under dual-task conditions and lead to improvements in cognitive tasks. Furthermore, the findings could potentially bring important insights regarding the impacts of improvements in walking abilities and cognition.

Socially speaking, the findings could potentially bring important insights regarding the impacts of improvements in walking abilities and cognition. If the elderly maintain safe gait patterns that prevent falls, they could reach self-sustained community participation and consequently reduce the burden of care on the family and caregivers. Additionally, the public health system may ultimately receive important positive economic and social impacts. This clinical trial may be reproduced in research and clinical practice environments.

Eligibility Criteria:
Inclusion Criteria:

* Elderly women will be eligible if they are between 69 and 79 years of age, have at least three years of schooling,have no cognitive deficits, as determined by the scores on the Mini-Mental State Examination, adjusted for their education levels: ≥23 for three years, ≥25 for four to seven years, and ≥26 for eight or more years of school.

Exclusion Criteria:

* Participants will be excluded if they have neuromusculoskeletal diseases,which could restrain physical activities or make use of medications, which could interfere with motor performance and/or memory.
Skype for Youth With Poorly Controlled Diabetes

Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM. Examined the differential impact on the youth's adherence to the diabetes medical regimen and the youth's blood sugar control.


Eligibility Criteria:
Inclusion Criteria:

* Youth between the ages of 12 and 18 with type 1 diabetes characterized by an HbA1c value great than 9%
* Caregivers willing to participate
* Family members reading English at 5th grade level
* Willing to be randomized.

Exclusion Criteria:

* Youth with intellectual disability
* Parent or youth who doesn't speak English
An Observational Chart Review Study To Describe The Real-World Outcomes And Use Of Avelumab In Combination With Axitinib For Treatment Of Patients With aRCC In The UK

An observational chart review study to describe the real-world outcomes and use of avelumab in combination with axitinib for treatment of patients with advanced renal cell carcinoma in the United Kingdom.


Eligibility Criteria:
Inclusion criteria

* Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
* Patients with a documented diagnosis of aRCC.
* Patients aged ≥18 years old at the index event date.
* Patient initiated on treatment with avelumab in combination with axitinib ( ≥1 dose) on or after 1st August 2019.

Exclusion criteria

* Patients meeting any of the following criteria will not be included in the study:
* Patients who received avelumab in combination with axitinib as part of a clinical trial
* Patients initiated on avelumab in combination with axitinib less than 12 months from the end of data collection.
* Patients who are known to have opted out of participation in any research