cyrilzakka/clinical-trials huggingface dataset:
BAY1436032 in Patients With Mutant IDH1(mIDH1) Advanced Acute Myeloid Leukemia (AML)

To determine the maximum tolerated and / or recommended Phase II dose of oral mutant IDH1 (mIDH1) inhibitor BAY1436032 and to characterize its safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy in patients with mIDH1-R132X advanced acute myeloid leukemia (AML)


Eligibility Criteria:
Inclusion Criteria:

* Patients with advanced AML that harbors IDH1 mutation
* Patients are relapsed from or refractory to at least 1 previous line of therapy
* Good kidney and liver function
* Male or female patients
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Women must have a negative serum pregnancy test within 7 days prior to the first dose of study drug or be surgically or biologically sterile or postmenopausal

Exclusion Criteria:

* Previously treated with any prior mIDH1 targeted therapy
* Extramedullary disease only
* History of clinically significant or active cardiac disease
* Active clinically significant infection
* Unresolved chronic toxicity of previous AML treatment
* Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors
* Pregnancy or breast-feeding
PROVIZ - a Machine Learning Software, to Support Targeting of Prostate Biopsies on MR Images in Biopsy-naive Patients

To perform a traditional feasibility clinical investigation, as defined in ISO 14155:2020, to investigate preliminary feasibility, safety, and clinical performance information of a near-final design of the investigational software. This will be performed through a prospective clinical study on biopsy naïve men with suspected prostate cancer examined with MRI at St. Olavs Hospital, Trondheim, Norway, in order to adequately plan an appropriate pivotal clinical investigation.

In this prospective study, after referral for suspected prostate cancer, the patient is scanned with magnetic resonance imaging (MRI) in accordance with guidelines of the standardized healthcare pathway. For consenting patients, the images are interpreted in two ways: first, in the conventional manner, i.e., manually by a radiologist, to determine whether clinically significant cancer is suspected. If so, the radiologist will delineate the suspicious lesions. In the second approach, the software will perform the same task as the radiologist, but automatically. If either or both interpretations point to significant cancer, the patient will be sent for targeted biopsy sampling. Histopathologic evaluation of the samples will then determine whether significant cancer is present in each of the targeted lesions (delineated by the radiologist, software, or both).

Feasibility is evaluated by measuring the overall failure rate of the software. This is measured by the technical performance log automatically generated by the software, which records all errors and failures during the study. If the record showed an overall failure rate less than 10% across all subjects, the software will be considered feasible.

The safety of the software is evaluated by the records of the serious adverse device effects (SADEs) of the software during the study. The software will be considered safe with no occurrence of death or serious injury.

The results of the histopathological evaluation will be used to evaluate the performance of the investigational software. This allows comparisons to be made between results obtained with the traditional manual approach alone, with the software alone, and with the manual approach assisted by the software. Statistical analysis will be performed to determine if there are significant differences and if the software adds value.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-naive men undergoing MRI examination for suspected prostate cancer via the Norwegian standardized care pathway.
* Patients who give consent to participate during the enrollment period.

Exclusion Criteria:

* Patients who have undergone a biopsy for prostate cancer in the past 3 years.
* Patients who currently enrolled in an active surveillance program for prostate cancer.
* Patients who have had hip replacements that may affect the quality of the image.
* Patients with claustrophobia.
* Patients who intolerance to glucagon or buscopan.
* Patients who unable to sign the informed consent themselves.
Kinematics of Lower Limb, Pain and Function of the Women With Patellofemoral Pain Syndrome

Assess pain, function, trunk and lower limbs kinematic during functional tasks after hip muscle strengthening versus hip muscle strengthening and sensory motor training in lower limbs.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary women,
* previous knee pain last 3 months in at least two of the following activities: sitting for long periods, walk up or down stairs, squat, running and jumping

Exclusion Criteria:

* Lower limb surgery,
* patella displacement
* knee instability
* Heart or locomotor disorders which might influence the evaluation
COgnitive Intervention to Restore Attention Using Nature Environment

Heart failure is a prevalent and serious public health concern with the growing aging population. Patients with heart failure often experience attention impairment that decreases their ability to perform self-care and diminishes their health-related quality of life. In past studies, 15 - 27% of heart failure patients had attention impairment. Attention is fundamental to human activities including self-care management of heart failure. However, cognitive interventions focusing on attention are scarce in heart failure literature. This study focuses on developing a novel cognitive intervention specifically targeting improved attention and testing its efficacy on improving attention, self-care, and health-related quality of life.

The investigators in this study are asking the following 3 questions: 1) does the newly developed cognitive intervention using immersive virtual reality technology (Nature-VR) improve attention compared with the control condition (Urban-VR)?; 2) does Nature-VR intervention improve HF self-care and health-related quality of life compared with Urban-VR control condition?; and 3) are selected biological factors associated with attention function in HF?

The virtual reality-based cognitive intervention (Nature-VR) can be an efficacious intervention for the patients to use and enjoy without burdening already reduced attention. This study has great potential to improve attention and prevent attention impairment, thereby leading to healthier lives among heart failure patients.

Heart failure (HF) is a prevalent serious chronic illness that affects 6.5 million American. Among HF patients, prevalence of attention impairment is reported as 15-27%. Attention is fundamental to human activities including HF self-care. However, cognitive interventions focusing on attention are scarce in HF. The investigators developed a new cognitive intervention with immersive virtual reality technology and created a prototype of the virtual reality-based natural restorative environment intervention (Nature-VR). The prototype was feasible and showed larger effects in improving attention among 10 HF patients.

In this 2-group randomized controlled pilot study, specific aims are to: 1) examine preliminary efficacy of Nature-VR compared with Urban-VR on improving attention; 2) examine preliminary efficacy of Nature-VR compared with Urban-VR on HF self-care and health-related quality of life; and 3) explore possible biomarkers of attention in HF. This study is important and novel because this is the first intervention study targeting attention using virtual reality technology and investigating possible biomarkers associated with attention in HF patients.

Eligibility Criteria:
Inclusion Criteria:

* adults (\> 21 years)
* diagnosed with chronic HF Stage C
* able to communicate in English

Exclusion Criteria:

* uncorrected visual impairment
* major neurological disease (e.g., Alzheimer disease, Parkinson's disease)
* major psychiatric disease (e.g., schizophrenia, bipolar disease)
Laser Therapy on Neuromuscular Performance

Objective: Investigating the immediate effects of Low Level Laser Therapy (LLLT) on neuromuscular performance in healthy subjects after an induced muscle fatigue protocol. Methods: Eighty volunteers of both genders aged between 18 and 28 years underwent a preliminary evaluation using surface electromyography and isokinetic dynamometer of the flexor muscles of the elbow. The subjects were randomly allocated into 4 groups: G1 was control group; G2 placebo; G3 laser applied before fatigue protocol; and G4 immediately after. Muscular fatigue protocol consisted of 30 maximal concentric isokinetic contractions at 120°/s of the elbow flexor muscles. An 808 nm equipment was used for applying laser therapy, with a power of 100 mW and total energy of 20 J. Volunteers were reassessed after interventions.


Eligibility Criteria:
Inclusion Criteria:

* Being between 18-28 years of age, having no pain in the shoulder area, elbow or hand, and not having suffered any to injury to the assessed upper limb in the last six months.

Exclusion Criteria:

* Presenting pain that prevented the completion of the evaluation, subjects whose data were improperly recorded or if the volunteer withdrew from the study.
Ultrasound Assessed Gastric Volume in the Fasted Pediatric Cerebral Palsy Patients

In patients with cerebral palsy, delayed gastric emptying and esophageal sphincter dysfunction are very commonly observed.

Pulmonary aspiration of gastric contents causes aspiration pneumonia, which greatly affects patients' prognosis, including hospital stay and mortality.

In the case of patients with cerebral palsy, there is a limitation in respiratory function, so more attention is required.

Therefore, this study aims to evaluate the risk of aspiration by measuring gastric volume after fasting for surgery in children with cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* patients with cerebral palsy under the age of 18 scheduled surgery under general anesthesia

Exclusion Criteria:

* the patient who feed through Levin tube or gastrostomy tube
* refusal to participate
Evaluation of Maintenance Dosing vs Loading Dosing Upon Restarting Warfarin Therapy: A Prospective Randomized Trial

A prospective, randomized trial to compare the time taken to achieve a therapeutic INR upon re-starting warfarin at a "loading" dose (namely 1.5 times the "maintenance" dose for 3 days) compared to the known "maintenance" dose.

Patients will be identified via the University of Alberta Hospital Anticoagulation Management Service. Following the receipt of written, informed consent, patients will be randomized to re-start warfarin at their "maintenance" dose or at a "loading" dose (1.5 times the maintenance dose for 3 days, then resumption of warfarin dosing as per the maintenance dose). Randomization will be performed on-line through the EPICORE Centre.

Assuming Day 1 is the day warfarin is re-started, patients will have INRs done on day 3 and at least every 2 days thereafter until a therapeutic INR is obtained. In addition, protein C, protein S and factor II levels will be obtained while the patient is on stable maintenance dosing of warfarin (i.e., prior to holding warfarin for the procedure), 7 days after re-starting warfarin, and 14 days after re-starting warfarin. Complete blood counts (CBCs) will be done with each INR if the patient is taking a low molecular weight heparin (LMWH). Patients will have their anticoagulant therapy managed by the AMS for 6 weeks and will receive a telephone follow-up by the AMS at 90 days to determine if any bleeding or clotting complications occurred.

Eligibility Criteria:
Inclusion Criteria:

* Have 'stable warfarin maintenance dosing' (defined as last 2 INRs within therapeutic range with weekly warfarin dosing not being changed any more than 10%)
* Have an INR indicative of not taking any warfarin (INR \<1.4) or confirmation of the patient not taking any warfarin in the past 4 days
* Provide written, informed consent
A 52-Week Placebo-Controlled Study Evaluating the Safety of Varenicline

The primary purpose of this study is to obtain safety information on cigarette smokers treated with 52 weeks of varenicline regardless of smoking status.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have smoked an average of at least 10 cigarettes per day during the past year and over the month prior to the screening visit, with no period of abstinence greater than 3 months in the past year.

Exclusion Criteria:

* Subjects with clinically significant, recent cardiovascular disease.
A LONGITUDINAL OBSERVATIONAL STUDY to EVALUATE the EFFICACY of MOVEMENT and IMPLEMENT CONCRETE MOVEMENT RECOMMENDATIONS with the HELP of MOBILITY TRACKING with SMARTWATCHES in SUBJECTS with AXIAL SPONDYLOARTHRITIS

Axial spondyloarthritis (axSpa) is a chronic inflammatoric autoimmune disease of the back with a prevalence around 1,4% (1) . In patients decreased function and decreased quality of life as well as chronic pain are strong burdens . Despite modern treatments like biological agents just 25% of the patients are at remission (2) . Besides the pharmacological treatment physical activity is known to be very important to gain disease control. A low physical activity is related to a higher disease activity and a high physical activity to better disease control. Until now there is no structured capture of the daily movements of patients with axial spondylarthritis in clinical practice. Our goal is to analyse the relationship between movement and disease activity and to implement concrete recommendations for movement in patients with axSpa.

The primary objective of the study is to investigate which type, frequency and intensity of movement are helpful in gaining and remaining disease control in patients with axSpa.

Methods This monocentric longitudinal study recordes movement, sport and physical parameters like heart frequency and heart rate variability through an observational period of 6 month via smartwatch. Meanwhile we record disease activity, pain and functional outcomes with regular surveys every two weeks. Patients in every phase of disease are eligible for inclusion, but they do must have an own iPhone due to software reasons. Data is collected in a specially programmed study-app. Fifty participants will be included in this study. Until now we have 24 patients included since april 2024. Patients come to clinic every 3 month as this is our standard in outclinic patients. We than do anamnesis and a physical examination. After the study period of 6 month we transmit the mobility and disease-related data of the surveys of the patients mobile device to our system.

The primary endpoint is to find exact recommendations for concrete movement in patients with axSpa.

So this is the first study that wants to give concrete recommendations for movement in patients with axSpa with the help of mobility tracking with smartwatches. This could help to prevent flares and also to recover quicker from a flare.

1. López-Medina und Moltó, "Update on the epidemiology, risk factors, and disease outcomes of axial spondyloarthritis".
2. Pina Vegas u. a., "Factors associated with remission at 5-year follow-up in recent-onset axial spondyloarthritis: results from the DESIR cohort".


Eligibility Criteria:
Inclusion Criteria:

* Patients with Axial Spondyloarthritis
* Patients do must have an own iPhone due to software reasons
* do must be willing and able to wear a Smartwatch
* do must be able to regularly fill out the PROs at home

Exclusion Criteria:

* no iphone
* no physical or mental Ability to wear a Smartwatch
* no physical or mental Ability to regularly fill out the PROs at home
Comparison of Bladder Filling vs. Non-Filling in Cesarean Hysterectomy for Placenta Percreta

The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates. including less blood loss, fewer transfusion requirements and, intraoperative urinary tract injury as well as improve fetal outcome.

Ultrasound evaluation is the recommended first-line modality for diagnosing PAS. Ultrasound features suggestive of PAS include loss of the normal retroplacental clear zone, attenuation of the uterine-bladder interface, reduced retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder. A systematic review reported that the antenatal diagnosis of PAS significantly lowered the rate of urinary tract injury (from 63% to 39%) during cesarean hysterectomies in these cases.

Unlike other elective cesarean hysterectomies, cesarean hysterectomy with a placenta previa increta/percreta, is more difficult. There is a greater need to both keep a margin from the vascular cervical-placental mass and simultaneously protect the urinary bladder. Case series reported that bladder filling helps the surgeon to more clearly identify the planes of dissection and secure the engorged aberrant vessels, thereby reduces bladder injury. Accordingly, a prospective randomized study in pregnant patients with placenta previa increta/percreta undergoing elective cesarean hysterectomy will be conducted to address this important issue.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in their third trimester (35-37 W).
* Placenta previa accreta spectrum identified by the Ultrasound (low lying anterior or major degree anterior).
* With at least one prior cesarean section.
* Elective cesarean hysterectomy.
* Evidence of gross placental invasion at the time of surgery (FIGO grade 3a.

Exclusion Criteria:

* Patients undergoing conservative treatment.
* Emergency cesarean hysterectomy.
* No evidence of gross placental invasion at the time of surgery.
* Posterior placenta.
Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

Patients with early gastric cancer, who require therapeutic upper gastrointestinal endoscopy, such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive intragastric spraying of NPO-11 or placebo. The superiority of NPO-11 to placebo as anti-peristaltic agent will be verified in a randomized, double-blind, parallel-assignment design based on the proportion of patients with suppressed gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by an independent committee.

The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration in comparison with the placebo group.


Eligibility Criteria:
Inclusion Criteria:

inpatients or outpatients of either sex who require therapeutic upper gastrointestinal endoscopy (EMR or ESD) and meet the criteria (1)-(4) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study. The criteria (2) and (3) will be confirmed by the endoscopic observation just before starting the intended treatment.

1. Patients with an early gastric cancer located in the lower third of the stomach, who require therapeutic upper gastrointestinal endoscopy (EMR or ESD) (except for those with an intended treatment by using a scope of \<9 mm in diameter)
2. Differentiated -type intramucosal gastric cancer or the suspected lesion, ≤ 2 cm in size, no ulcer finding
3. Patients with a single intended lesion for the treatment
4. Patients who are older than 20 years at the time of consent

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study beforehand. The criteria (3) to (5) will be confirmed by the endoscopic observation just before starting the intended treatment.

1. Patients with a history of surgery to the upper gastrointestinal tract
2. Patients who require emergency endoscopy
3. Patients with severe gastric stenosis or deformation which makes observation of gastric peristalsis difficult
4. Patients who require emergency endoscopic treatment except for the intended lesion
5. Patients with a lesion extended to the pyloric ring
6. Patients with an ongoing cancer treatment (chemotherapy or radiotherapy)
7. Patients with pacemaker
8. Patients with known bleeding tendency or Patients with difficulty of antithrombogenic agents withdrawal
9. Patients with a history of shock or hypersensitivity to l-menthol or peppermint oil
10. Patients with contraindications to glucagon
11. Patients with contraindications to benzodiazepines, pethidine hydrochloride, and epinephrine
12. Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
13. Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
14. Patients otherwise ineligible for participation in the study in the investigator's opinion
Impact of Interactive ICU Diary on Psychological Distress

This study investigates the effectiveness of a technology-driven, interactive ICU diary in reducing psychological distress, specifically anxiety, depression, and stress, in ICU patients. A single-blind, parallel-group randomized controlled trial will include 56 conscious ICU patients. The primary outcome measures are the Depression, Anxiety, and Stress Scale-21 (DASS-21) and the EuroQol instrument (EQ-5D), assessed at ICU admission, discharge, and one month post-discharge.

This study investigates the effectiveness of a technology-driven, interactive ICU diary in reducing psychological distress, specifically anxiety, depression, and stress, in ICU patients. A single-blind, parallel-group randomized controlled trial will include 56 conscious ICU patients, randomly assigned to either the interactive diary group or the standard care group. The interactive diary allows patients to share their feelings and needs via a platform, while family members can send supportive messages, pictures, and videos. Healthcare providers can connect with families and monitor patient conditions through the platform. The primary outcome measures are the Depression, Anxiety, and Stress Scale-21 (DASS-21) and the EuroQol instrument (EQ-5D), assessed at ICU admission, discharge, and one month post-discharge. The expected results indicate that the interactive diary will significantly alleviate psychological distress during the ICU stay and improve post-discharge quality of life, providing valuable insights into enhancing the mental health and overall well-being of ICU patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Clear consciousness and able to communicate in Mandarin, Taiwanese, or Hakka
* Expected ICU stay of at least 72 hours
* Ability to operate a smart device and use social media applications

Exclusion Criteria:

* Presence of delirium before joining the study (Intensive Care Delirium Screening Checklist score ≥ 4)
* Physical, auditory, or visual impairments preventing the use of smart devices History of epilepsy, cognitive impairments (e.g., hepatic encephalopathy, dementia), or psychiatric disorders
* Richmond Agitation-Sedation Scale score not between +1 and -1 (indicating excessive sedation or agitation)
* Acute Physiology and Chronic Health Evaluation Score (APACHE-II) \> 25 within the first 24 hours of ICU admission (indicating \> 50% mortality rate)