cyrilzakka/clinical-trials huggingface dataset:
A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors

The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.


Eligibility Criteria:
Inclusion Criteria:

* For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.

  * For dose escalation for all combinations: The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.
  * For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  * For Part B dose confirmation: All participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  * For Part C dose confirmation: All participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  * For Part D dose confirmation: All participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received \>1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease).
  * For Part E dose confirmation: All participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (TNBC) and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received \>2 lines of systemic treatment for advanced or metastatic TNBC.
* Have adequate organ function.
* Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Have discontinued all previous therapies for cancer.

Exclusion Criteria:

* Have current acute leukemia.
* Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.
The Effect of Neurofeedback-assisted Mindfulness Training in Employees With Emotional Labor

The purpose of this study is to verify the effect of neurofeedback-assisted mindfulness training for workers. Subjects who can participate in the screening are assigned to one neurofeedback-assisted mindfulness training group, mindfulness only training group, and self-treatment group. The neurofeedback-assisted mindfulness group and the mindfulness group meet with psychologist and have education for the mindfulness training with or without neurofeedback respectively, a total of 4 times, once a week. On the other hand, the self-treatment group provides self-education by providing the stress education kit.

After screening, Pre-evaluation is conducted on the subjects who agreed to participate in the study. Pre-assessment includes questionnaires related to stress, emotional labor, resilience, sleep, etc., and includes stress-related physiological measures using HRV, 2 lead EEG. After the pre-evaluation, the neurofeedback-assisted mindfulness and mindfulness training group will have education sessions with a psychologist for 30 minutes at a time, once a week, for a total of 4 sessions (one month for a period). The education includes the instruction of the application including mindfulness training, with or without neurofeedback, and the review for the accomplishment of the training. Participants should follow the instruction and the training schedule which is arranged in advance. On the other hand, for a self-care control, the education sessions are not provided and self-learning materials are provided once a week. The purpose of the study is to find the effectiveness of mindfulness training on reduction of stress and severity of emotional labor. Especially, mindfulness training group with neurofeedback might be expected to show the highest improvement in various clinical scales and biomarkers including EEG and HRV.

Eligibility Criteria:
Inclusion Criteria:

* Workers over the age of 19 and under 65
* In the Perceived Stress Scale 14 points or more
* If you are currently taking medication due to psychiatric illnesses such as depression, anxiety disorder, insomnia, etc., the dose must be stabilized for last 6 months, is expected to have no change in drug dose during the clinical trial
* If you understand the protocol and voluntarily agree to participate
* If you have an Android phone

Exclusion Criteria:

* Age under 19, adult over 65
* If you have dementia, intellectual disability, or other cognitive impairment
* If you have convulsive disorder, stroke, or other neurological disorder
* If you have psychosis such as schizophrenia or bipolar disorder or you have a history
* If you have a disease that can affect the reliability of HRV test, such as heart disease or lung disease.
* Has received non-pharmacological psychiatric or counseling treatment within the current or last 6 months.
Risk Assessment and Mechanism Analysis of Intracranial Multiple Aneurysm Instability Based on High-resolution Magnetic Resonance, Imaging Histology and Hemodynamics

This project proposes to establish a prospective cohort of MIA based on a preexisting multicenter MIA database and to combine multidimensional methods such as high-resolution magnetic resonance, hemodynamics, ambulatory blood pressure, and imaging histology to study aneurysm instability.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years old, male or infertile female;
* Diagnosed as IA (intracranial aneurysm) through CTA, MRA, or DSA; And it is suitable for endovascular intervention treatment
* The patient and/or their legal representative or guardian fully understand the research purpose, voluntarily participate and sign informed consent Books;
* Patients willing to cooperate with high-resolution magnetic resonance imaging.
* Patients willing to follow up and evaluate according to clinical research protocol requirements

Exclusion Criteria:

* AVM (arteriovenous malformation), Moyamoya disease, or DAVF (dural arteriovenous fistula) related aneurysms;
* Patients with contraindications for high-resolution magnetic resonance imaging;
* Participants in clinical trials of other drugs or medical devices;
* Patients with severe underlying diseases and extremely poor clinical conditions who cannot tolerate general anesthesia surgery;
* Patients with poor compliance and inability to cooperate with follow-up;
* Possible or clear history of severe allergy to contrast agents;
* Patients with a life expectancy of less than 2 years;
* Women who are breastfeeding and preparing for pregnancy during the study period
Correlation Between Postoperative Cognitive-related Adverse Reactions and Brain Metabolomic Characteristics in Elderly Patients

Postoperative cognitive dysfunction (POCD) refers to the difficulties of orientation, cognition, communication, memory and abstract thinking of patients after anesthesia and surgery. And/or accompanied by the decline of the ability in social activities, such as the change of personality, social ability of language and behavior, cognitive function and life skills. POCD is a common complication of central nervous system in elderly patients after operation, with an early incidence of about 21% and a long-term incidence of about 35% . According to the current research on Alzheimer's disease (AD) and POCD in the elderly, it has been found that they have similar pathological basis and some homologous related genes. Altogether, POCD is closely related to molecular pathway neuropsychiatric diseases (such as dementia, depression and Alzheimer's disease). Researchers have come up with various hypotheses to reveal the underlying mechanisms of POCD, including neuritis, oxidative stress, autophagy disorder, synaptic dysfunction, and lack of neurotrophic support. To date, apart from evaluating with scales, CT Scan and EEG analysis, there is neither exact biomarkers for monitoring and diagnosing POCD, nor clear relationships between specific Brain Metabolomic Characteristics, EEG changes and diagnosis of POCD, so that the diagnosis of early POCD only stays in the evaluation of clinical symptoms and scales. Therefore, our study aims to provide an effective basis for early diagnosis and treatment of clinical POCD through multivariate analyses of clinical scales combined with Brain Metabolomic Characteristics, EEG analysis of patients.


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older .
* Complete the operation in our hospital
* ASA classification I-II level
* Agree to participate in this research and agree to sign an informed consent form

Exclusion Criteria:

* History of preoperative psychosis and psychotropic drug use
* The subject is diagnosed with AD;
* Abnormal preoperative mental scale assessment
* Have a history of emergency rescue during the perioperative period
* metal implants
* Postoperative immobilization patients
Study on Efficacy of Add on Selenium in Mild-to-moderate Graves Ophthalmopathy

The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial.; The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors.

The Study on efficacy of add on selenium in mild-to-moderate Graves ophthalmopathy: A Randomized Control Trial. The study aims to evaluate the response of adding selenium in patients with Graves ophthalmopathy, focusing on improving quality of life, CAS scoring, and thyroid status. The methodology involves a Randomized Control Trial with a sample size of 78 patients. Patients meeting specific criteria will receive either standard treatment with Anti Thyroid Drugs and Vitamin B complex or add on selenium with Vitamin B complex for 6 months. Outcome measures include CAS score reduction, thyroid function improvement, and quality of life enhancement. The study will last 18 months, with various investigations and ethical considerations outlined. The document emphasizes the importance of early diagnosis of Graves Ophthalmopathy to prevent vision loss and deformity, highlighting the significance of informed patients and healthcare professionals regarding TED symptoms and risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Mild-to-moderate Grave's Ophthalmopathy in Age group \>18years

With only one or more :

* Retraction of lid \<2 mm
* Mild soft tissue involvement
* Proptosis of \<=3 mm
* Corneal exposure that responds to lubricating eyedrops.
* Patients with CAS \< = 4
* Patients diagnosed with hyperthyroidism converted to euthyroid since 2 months with Anti Thyroid Drugs.
* Those who are willing to follow the advised treatment and timely follow ups.

Exclusion Criteria:

* Treatment with any steroid (Intravenous, oral or topical) for any condition within 3 weeks before presentation.
* Any treatment with rituximab
* Any earlier treatment with teprotumumab.
* Any treatment with monoclonal antibody within 3months before presentation.
* Lactating or pregnant women
Effect of High Dose Ciclesonide on Asthma Control

The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent was provided
* History of persistent bronchial asthma for at least 6 months
* Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose range of 200-1000 μg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12 weeks
* Good inhalation technique
* Under the current ICS pre-treatment the ACQ score ranges between ≥ 0.75 and ≥ 2

Exclusion Criteria:

* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Concomitant severe diseases (e.g. malignant diseases during the past 5 years \[other than basal or squamous cell carcinoma\], hepatitis C, acquired immune deficiency syndrome \[AIDS\])
* Diseases which are contraindications for the use of ICS (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
* Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
Dose Ranging Study of OTO-201 in AOMT

Dose Ranging Study of OTO-201 in AOMT

This is a 1-month, prospective, multicenter, randomized, dose-ranging, sham-controlled, blinded study in which eligible subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT) will receive a single administration of 6 mg OTO-201, 12 mg OTO-201, or sham into the affected ear(s).

Eligibility Criteria:
Inclusion Criteria includes, but is not limited to:

* Subject is a male or female aged 6 months to 17 years, inclusive
* Subject has a clinical diagnosis of acute otitis media with tympanostomy tubes (AOMT)
* Subject's caregiver is willing to comply with the protocol an attend all study visits

Exclusion Criteria includes, but is not limited to:

* Subject has a history of sensorineural hearing loss
* Subject has tympanic membrane perforation other than the surgical tympanostomy tube perforation
* Subject has a history of known immunodeficiency disease
ESPRESSO (Epidemiology Strengthened by histoPathology Reports in Sweden)

The ESPRESSO study is a collection of data from all computerised gastrointestinal histopathology reports in Sweden. This allows us to study risk factors for gastrointestinal disease, as well as the prognosis of gastrointestinal disease.

A review of the study has been published here:

https://pubmed.ncbi.nlm.nih.gov/30679926/

The ESPRESSO study constitutes a novel approach to examine the etiology and prognosis of gastrointestinal disease in which histopathology plays a prominent role. Between 2015 and 2017, all pathology departments (n=28) in Sweden were contacted and asked to procure histopathology record data from the gastrointestinal tract (pharynx to anus), liver, gallbladder, and pancreas. For each individual, local histopathology IT personnel retrieved data on personal identity number, date of histopathology, topography (where the biopsy is taken), morphology (biopsy appearance), and where available free text. In total, between 1965 and 2017, histopathology record data were available in 2.1 million unique individuals, but the number of data entries was 6.1 million because more than one biopsy was performed in many of the study participants. Index individuals with histopathology data were matched with up to five controls from the general population. The investigators also identified all first-degree relatives (parents, children, full siblings), and the index individual's first spouse. The total study population consisted of 13.0 million individuals. Data from all the study participants have been linked to Swedish National Healthcare Registers allowing research not only on such aspects as fetal and perinatal conditions and the risk of future gastrointestinal disease but also on the risk of comorbidity and complications (including cancer and death). Furthermore, the ESPRESSO database allows researchers and practitioners to identify diagnoses and disease phenotypes not currently indexed in national registers (including disease precursors). The ESPRESSO database increases the sensitivity and specificity of already-recorded diseases in the national health registers. This paper is an overview of the ESPRESSO database.

Eligibility Criteria:
Inclusion Criteria:

* Any person with a computerised histopathology record from the gastrointestinal tract including the liver, gallbladder and the pancreas.
* Matched controls to any person with the above histopathology record.
* Spouses and first-degree relatives to any of the above.

Exclusion Criteria:

-None

(this is a registry-based study)
Evaluation of Blood Pressure Monitor With AFib Screening Feature

This study aims to evaluate the safety and effectiveness of the Omron blood pressure (BP) monitor with AFib screening feature. The primary outcome is to validate if the Omron BP-monitor with AFib screening feature meets acceptance criteria in sensitivity and specificity. The acceptance criteria of the sensitivity and specificity should be statistically non-inferior to those of primary predicate device.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are eligible to participate in the study if they meet all of the following criteria. AFib participants must meet criteria 1-5. non-AFib participants must meet criteria 1-3 and 6-7.

  1. Age ≥ 22 years old
  2. Arm size within 22 cm to 42 cm in circumference
  3. Participants who have an adequate understanding about the study and have given informed written consent before participation
  4. Participants who were diagnosed with AFib and have regularly seen a cardiovascular specialist
  5. Participants who have atrial fibrillation symptoms on ECG at the time of data collection
  6. Participants who have never been diagnosed with atrial fibrillation
  7. Participants who do not have AFib symptoms on ECG at data collection time

Exclusion Criteria:

* Participants will be excluded from the study if they meet any of the following criteria.

  1. Subjects who have difficulty in ECG or blood pressure measurement due to skin rashes or wounds on the chest or arm
  2. Women who are pregnant at the time of study participation.
  3. Subjects who have had a mastectomy.
  4. Subjects with pacemakers and/or defibrillators.
  5. Subjects who have difficulty in measuring blood pressure or ECG measurements in the sitting position.
  6. Subjects who are hospitalized (in-patients)
  7. Subjects whose pulse rate is less than 40 beats/minute or more than 180 beats/minute.
  8. Subjects who have had an arterio-venous shunt or an intravascular access on either arms.
  9. Subjects who have heart failure class III or IV.
  10. Subjects who at the beginning of the scheduled study time experience any of the following newly developed conditions within the past 3 hours: chest pain, paralysis or numbness (face, arm or leg), trouble speaking or understanding, visual field loss in one or both eyes.
Effect of MRP With and Without EMS on Gait, Functional Independence and QOL in Stroke Patients

To determine the effects of motor relearning programme with and without electrical muscle stimulation on gait, functional independence and quality of life in hemiplegic stroke patients.

A study was performed a motor relearning program in stroke survivors. A clinically significant improvement was found in the motor relearning groups, and only in one study is this improvement significant compared to another intervention.

Neuromuscular Electrical Stimulation Improves Activities of Daily Living Post-Stroke. While the potential for enhancing functional motor ability seems less clear, the current systematic review and meta analysis's results point to a significant positive impact of NMES on ADL function during the post stroke rehabilitation process.

People with hemiparesis who received both conventional treatment and interventions based on motor relearning showed a significant improvement in their level of disability. There were no appreciable gains in the HRQoL perception.

Many research investigations have been carried out to assess the effects of motor relearning programs with regard to specific functional aspects and physical deficiencies. Up to the researcher's knowledge, there is no data to assess the effects of electrical muscle stimulation along with motor relearning programs in stroke patients. Therefore, the purpose of this study is to compare how a motor relearning program with and without electrical muscle stimulation affects hemiplegic stroke patients' gait, level of functional independence, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as hemiplegic stroke

  * Age between 45-65 years
  * Both males and females
  * Mini-Mental State Examination score ≥24
  * Able to stand independently for at least 1 min and (5) can ambulate 25 feet/10 m (with or without the assistive device)

Exclusion Criteria:

* Experiencing balance problems as a result of neurological conditions other than stroke (for instance cerebellar impairment, inner ear dysfunction, or Parkinson's disease)

  * Fixed ankle or foot contracture.
  * A serious cardiac disease (aorta stenosis, angina, hypertrophic cardiomyopathy, arrhythmia and pacemakers).
  * congenital limb deformities
PMCF Study of the CE-marked Drainova® ArgentiC Catheter

The goal of this observational study is to learn about the performance of the drainova® ArgentiC Catheter in clinical routine, which is used to treat fluid accumulations in hollow body structures. The device is already on the market and participants receive the catheter as part of their regular treatment.

The main questions of this study are:

* Does the device function as intended?
* Are there any other safety risks that have not been identified?
* Does it lower the symptoms of the patients as intended?

Doctors and patients will answer questions regarding the improvement of the patients´ symptoms and if there were any problems with the catheter.

The drainova® ArgentiC Catheter initially received the CE mark in 2019 under the Medical Device Directive 93/42/EEC, thus being considered a legacy device under the Medical Device Regulation (EU) 2017/745 (MDR). In order to fulfill the requirements of the MDR, this PMCF study is planned to be conducted to obtain clinical data on the device confirming its safety, performance and clinical benefit in clinical routine according to the instructions for use (IFU).

This PMCF study is performed as a purely observational activity within the current standards of care and without additional invasive or burdensome procedures. The drainova® ArgentiC catheter is a catheter indicated for the treatment of patients with pleural effusions and ascites, both in the malignant and non-malignant manifestations.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Patients being able to give informed consent

Exclusion Criteria:

Patients with any contraindication according to the IFU:

* presence of septa in the body cavity
* coagulopathy
* infection in the body cavity
* lymphatic effusion
* shift of the mediastinum (by more than 2 cm to the ipsilateral side of the pleural effusion)
* known allergies to any of the materials used in the drainage product