cyrilzakka/clinical-trials huggingface dataset:
CYP2D6 Genotyping by AmpliChipTM CYP450 for Tamoxifen-Treated Breast Cancer Patients

The aim of the study is to examine whether tamoxifen-treated Israeli breast cancer patients who are CYP2D6 poor metabolizers (CYP2D6\*4/\*4 genotype) are at higher cancer relapse risk during 2.5-5-year follow-up period from initial diagnosis and primary treatment.

Tamoxifen, the first-line drug for preventing breast cancer relapse, is typically prescribed for a 5-year follow-up period after diagnosis and primary treatment of estrogen receptor-positive breast cancer. Recent studies show that tamoxifen is only a pro-drug, while its major active metabolite, endoxifen, is formed in vitro by the liver enzyme CYP2D6. Preliminary observations from the US and Italy have suggested that tamoxifen is less efficacious for cancer relapse prevention in patients with deficient CYP2D6 activities. The FDA is currently reviewing the new data and is likely to modify the tamoxifen label accordingly. It was suggested that an aromatase inhibitor drug such as letrozole might be more beneficial for these patients.

The proposed study would retrospectively test CYP2D6 genotypes in 200 - 300 estrogen receptor (ER) positive breast cancer patients who are treated with tamoxifen post-operatively. Blood collected with informed consent would be used for examining the patients CYP2D6 genotype, and identifying those who are CYP2D6 poor metabolizers (CYP2D6\*4/\*4 genotype), and for measurement of endoxifen blood level in those women who are on the drug.

AmpliChipTM CYP450 is a microarray chip which contains millions of tiny DNA molecules, providing comprehensive coverage of gene variations that play a role in the metabolism of approximately 25% of all prescription drugs. The AmpliChipTM CYP450 test is intended to be an aid for physicians in individualizing treatment doses for patients receiving therapeutics metabolized through these enzymes.

The clinical data collected would examine if these individuals, as well as those treated with CYP2D6 inhibiting drugs such as paroxetine and fluoxetine, have higher cancer relapse rates.

The study, combined with similar findings from other countries, and possibly integrated later on with an international network study, would be imperative for modifying treatment recommendations for breast cancer therapy. Specifically, if the US and Italian findings are confirmed, it might be advisable to switch the 5-year follow-up treatment for breast cancer patients with ER positive primary tumors who are CYP2D6 poor metabolizers from tamoxifen to an aromatase inhibitor drug such as letrozole.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age \> 18
* Treated with Tamoxifen following diagnosis of breast cancer

Exclusion Criteria:

* None
Serum Elafin and Vascular Affection in Behcet Disease

To measure the level of serum elafin in patients with BD. To assess the relation between serum elafin levels and disease activity. To evaluate the vascular complications in BD and determine their relationship with disease activity.

To assess the correlation between serum elafin and vascular affection and their relation with disease activity.

Behçet's disease (BD) is a chronic, multisystemic, inflammatory disease characterized by recurrent oral and genital ulcers and multiple systemic involvements. Elafin is a serine protease inhibitor produced mainly by epithelial cells. Its expression is upregulated by proinflammatory cytokines such as IL-1β and TNF-α that are potent stimulants of neutrophil activation, it counteracts the destructive effects of neutrophil elastase .Interestingly, previous reports documented the role of serum elafin in the pathogenesis of BD.In fact, vascular complications may be one of the earliest manifestations leading to the diagnosis of BD. There is no reliable tool to identify vascular wall inflammation in BD, except for detecting intravascular thrombosis with ultrasonography (US). Previous studies investigated arterial vessel wall thickness with US (mostly in carotid arteries) in BD . Venous wall inflammation presents with deep vein thrombosis and superficial thrombophlebitis . It was stated that lower extremity vein wall thickness (VWTs)was increased in BD patients independently of vascular activity and important in the diagnosis . However, studies in the literature evaluated only lower extremity VWTs, whereas the relationship of VWT with disease activity has not been emphasized .

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed as BD. Age of all participants (20-45) years.

Exclusion Criteria:

Age \<20 or \>45 years. Other autoimmune diseases. Cardiovascular diseases (heart failure, myocardial ischemia). Possible related risk factors (e.g. diabetes, dyslipidemia, smoking). chronic conditions (e.g. chronic kidney disease, malignancy, autoimmune diseases).
Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea

The main objective of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults

The main object of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults. Our primary hypothesis is that the ANNE Sleep system is non-inferior compared to polysomnography (PSG) for the diagnosis of obstructive sleep apnea

Eligibility Criteria:
Inclusion Criteria:

1. ≥22 years old.
2. Subjects with suspected OSA based on history and physical who qualify for, and have either a PSG or HSAT ordered, as determined by their regular provider. Subjects with self-reported symptoms of OSA based on the STOP-Bang questionnaire indicating affirmative answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners who have observed the subject stopping breathing or choking/gasping during sleep. Persons with a previous diagnosis of OSA are also eligible.
3. Willingness to give written consent and comply with study procedures

Exclusion Criteria:

1. An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection
2. Inability to understand instructions
3. Has a skin abnormality that precludes assessment
4. Has a history of dementia
5. Patients with implanted pacemakers or defibrillators
6. Subject is pregnant, nursing or planning a pregnancy over the expected course of the study
Biomarkers Related to PSCI: An fNIRS Study

This is an fNIRS study performed to identify biomarkers related to post-stroke cognitive impairment.

This was an initial screening and preliminary intervention study. Both healthy subject and stroke patients will be included in this study. Brain functional activation of each subject during the cognitive task (Stroop task, 1-back task and verbal fluency test) will be evaluated using functional near-infrared spectroscopy (fNIRS). Cognitive function related scale assessment included Mental State Examination Scale (MMSE), Montreal Cognitive Assessment (MoCA), drawing clock test (DCT), Shape trials test A.B (STT-A, STT-B), standardized digital modal test (SDMT), auditory verbal learning test-Huashan version (AVLT-H), and activity of daily living (ADL) scale will be used to evaluate the function of each patient. Biomarkers related to post-stroke cognitive impairment will be identified by by comparing differences in brain activation and brain network connectivity between patients and healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

Stroke patients:

1. Diagnosis of stroke confirmed by neuroimaging (CT or MRI)
2. 18-80 years old
3. Able to complete the cognitive task
4. Able to follow instructions to complete the trial
5. Patients who signed an informed consent form.

Healthy Subjects:

1. No abnormalities on cranial
2. 18-80 years old
3. Able to complete cognitive task
4. Able to follow instructions to complete the trial
5. not taking medications.
6. Subjects who signed an informed consent form.

Exclusion Criteria:

Stroke patients:

1. Inability to tolerate the test due to organic diseases
2. Serious mental illness that prevents them from cooperating with or tolerating the trial
3. Pregnant or lactating women
4. Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction.

Healthy Subjects:

1. Inability to tolerate the test due to organic diseases
2. Serious mental illness that prevents them from cooperating with or tolerating the trial.
3. Pregnant or lactating women
4. Had metal implants, a history of other neurological disorders, acute cardiopulmonary dysfunction
Incidence of Hoarseness After General Spine Surgery: Prospective Observational Study

Early diagnosis and appropriate treatment of hoarseness is known to improve quality of life and treatment outcomes. Therefore, appropriate research on the incidence of hoarseness after surgery is necessary. In this study, investigator aim to investigate incidence of hoarseness after spine surgery and the correlation between the Voice Handicap Index (VHI)-10, used as a criterion, and acoustic parameters, while also validating the efficacy of our research methods.

The primary outcome of this study is the incidence of hoarseness on the day of surgery.

The secondary outcomes include the incidence of hoarseness at one month after surgery, as well as examining the correlation between acoustic parameters, risk factors, and the occurrence of hoarseness.

Investigator conducted a comparative analysis of risk factor for hoarseness in patients with different VHI-10 scores on the day of surgery and 30 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Age range is 20 to 80 years old
* degenerative spine conditions
* visit at Seoul National University Hospital only
* Patients who voluntarily consent to participate in the study

Exclusion Criteria:

* History of surgery around the airway or mediastinum
* patients with vocal cord-related disorders
* Patients with fractures, bleeding, or other trauma
* Patients with neuromuscular diseases, Parkinson's disease, or psychiatric disorders
* Patients who cannot be extubated or who are transferred to the ICU after surgery
* Pregnant women
* Patients who do not wish to participate in the study
Evaluation of Microbial-derived TMAO Production From Carnitine Intake by Testing Fecal Bbu Gene

The risk of cardiovascular diseases from red meat consumption varies among individuals due to variations in gut microbiota. L-carnitine in red meat can be converted to TMAO in the body by certain bacteria. Not everyone experiences a significant increase in TMAO levels after consuming carnitine. Gut microbiota differences are observed between high and low TMAO producers. The presence of the bbu gene in gut microbiota is linked to TMAO production. This clinical research aims to determine if the bbu gene can predict TMAO levels after carnitine intake.

The risk of developing cardiovascular diseases due to the consumption of red meat varies among individuals, and this may be attributed to differences in the composition and function of gut microbiota. Studies have found that red meat, rich in L-carnitine, may be metabolized by certain anaerobic bacteria in the intestines to produce trimethylamine N-oxide (TMAO) in the human body. Previous research utilizing the oral carnitine challenge test (OCCT) revealed that not everyone experiences a significant increase in blood TMAO levels after consuming carnitine. Moreover, individuals with high TMAO production and low TMAO production showed distinct differences in their gut microbiota.

Furthermore, we have discovered a significant correlation between the presence of the bbu gene in gut microbiota and the production of TMAO in response to dietary carnitine intake. Therefore, through the design of clinical research, we aim to investigate and assess whether the abundance of the bbu gene in gut microbiota can predict the levels of TMAO produced in the human body after consuming carnitine.

Eligibility Criteria:
Inclusion Criteria:

* Adult with age between 18 to 70
* Must be able to swallow tablets

Exclusion Criteria:

* Antibiotics use within one month
* L-carnitine supplement use within one month
* Chronic diarrhea
* Myasthenia gravis
* Diabetes mellitus
* Parathyroid disorders
* Chronic kidney disease
* Epilepsy
* Severe anemia
* Cardiovascular diseases.
GammaGA: Prevalence of Acid Sphingomyelinase Deficiency Disease (ASMD) and Gaucher Disease in Patients With Monoclonal Gammopathies and/or Multiple Myeloma

The study of splenomegaly, and the follow-up of splenectomized patients, is one of the causes of referral of these patients to pediatric gastroenterology and oncohematology clinics, and adult internal medicine and hematology. The study and management of splenomegaly is well described among the different medical specialties to which these patients arrive. After the application of the different algorithms and the different studies that are carried out, these splenomegaly are identified as being of hepatic, infectious, inflammatory, congestive, hematological origin and primary causes. Despite these studies of splenomegaly, approximately 10-15% of these patients still remain undiagnosed.

Several studies have suggested that there is an increased frequency of MGUS (monoclonal gammopathy of undetermined significance) and/or multiple myeloma (MM) among Gaucher patients. Regarding ASMD (Acid Sphingomyelinase Deficiency), few studies have been published but it seems the 21% of patient with ASMD has MGUS and 15% ASMD patients have MGUS. Moreover, patients with MGUS and Gaucher disease (GD) are at increased risk of developing MM.

The objective of the present study is to increase the diagnostic sensitivity of these unknown splenomegalys, or unknown splenomegaly patients with MGUS or multiple myeoloma who remain in consultations, using the usual diagnostic clinical procedures of unknown splenomegaly and unknown splenectomy patients, where we include the extraction of a blood sample for dry drop test (DBS), where the determination of the enzymatic/genetic activity will be carried out for Gaucher disease (GD) and acid sphingomyelinase deficiency (ASMD) , analysis of LisoGl1 and LisoSM.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both sexes.
* Patients with splenomegaly (spleen palpable at ≥ 1cm from the costal margin) or splenectomy not related to any specific condition, or patients with thrombocytopenia (with or without splenomegaly). In cases where the patient is undergoing treatment for their underlying condition, the thrombocytopenia must have been present prior to the start of the treatment.
* Patient who gives their consent to participate in the study.

Exclusion Criteria:

* Splenomegaly due to portal hypertension (documented by abdominal ultrasound or other instrumental test) due to liver disease
* Hematologic malignancy \[documented by positive physical exam + blood smear or fine needle aspiration (FNA) or bone marrow biopsy\]
* Hemolytic anemia and/or thalassemia
* Patients who cannot meet the requirements of the protocol due to mental and/or cognitive alterations, uncooperative patients, educational limitations and understanding of written language
* Refusal of the patient to participate in the study
Biomechanical Assessment and Biofeedback-training System for Handwriting

The purpose of this study is to investigate the real-time kinetics of handwriting regarding the design of the utensil and fine motor performances from biomechanical perspectives. It includes three parts.

The first part is an observational study design and the specific aim of the first part of the study is to establish a novel kinetic assessment system incorporated with Force Acquisition Pens (FAPs) designed with different barrel sizes and shapes for handwriting. The thorough calibration, examination of reliability and validity will be presented in this study.

The second part is also an observational study design and the specific aim of the second part of the study is to investigate the handwriting mechanisms using the kinetic assessment system incorporated with the motion capture system with children who have writing difficulties.

The third part is an interventional study design and the aim of this final part is to integrate the kinetic assessment system and the intervention concept to establish a Biomechanical Assessment and Biofeedback-training System for Handwriting (BABSH). Comparison of the intervention effect of the BABSH and traditional training for the children with handwriting difficulties will also be carried out in this part.


Eligibility Criteria:
Inclusion Criteria:

1. Able to use pen to write
2. Children volunteers must study in elementary schools

Exclusion Criteria:

- Handwriting problems are related to muscular, skeletal, nerve and brain damage or disease.
Can Work be Organized to Become More Health Promoting for Employees in Home Care Services?

This is a two-group, cluster randomized controlled trial designed to assess a health promoting intervention in the home care sector. The intervention aims to evenly distribute the patients requiring high levels of demanding care across all workers on the units, which may lower the working strain and thus the incidence of musculoskeletal pain. The two groups in the study will be a control group and an intervention group. The intervention will last for approximately 4 months.

This is a two-group cluster randomized controlled trial to compare an organizational intervention to control. The home care units will be treated as clusters to avoid contamination within units.

Control group: No intervention, their work will continue as usual without any instructions from researchers.

Intervention group: The intervention will consist of the operational managers distributing the physically strenuous shifts evenly between the workers in each home care unit. This will be achieved using a tool developed in Microsoft Excel which gives an overview over how much strain we expect each shift to have and gives a score on how well the operational manager distributes the strain between employees.

The intervention will last for approximately 4 months, depending on duration of pre and post measurements.

Eligibility Criteria:
Inclusion Criteria:

* Home care worker in one of the included home care units in Trondheim municipality.
* More than or equal to 50% working position at the home care unit.

Exclusion Criteria:

* Physically incapable of performing day to day tasks.
* Any illness during the measurement week
* Pregnancy
Stereotactic Radiotherapy for Oligo-Progressive Metastatic Cancer (The STOP Trial)

A multicenter randomized phase II trial of stereotactic body radiotherapy for oligo-progressive metastatic cancers. Eligible patients will be randomized in a 1:2 ratio between receiving their standard of care therapy or stereotactic ablative radiotherapy (SABR) to all sites of oligo-progressive lesions.Radiotherapy will be administered as soon as possible following randomization, and subjects will be followed until next disease progression. The primary outcome is progression-free survival (PFS).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Willing to provide informed consent
* Histologically confirmed Non-Small Cell Lung Cancer (NSCLC) with metastatic disease detected on imaging. Biopsy of metastasis at some time point prior to enrollment is preferred, but not required.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy \> 3 months
* Patient has received treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies) during the past 6 weeks. This most recent systemic therapy agent must have been delivered for a total of at least 3 months, with an initial partial response (PR), complete response (CR) or stable disease (CR) prior to the development of oligo-progressive lesions.
* Oligoprogression, defined as Response Evaluation Criteria in Solid Tumors (RECIST)-documented progression in up to 5 individual lesions, with no previous radiation or radiofrequency ablation to those sites. Oligoprogression may be defined as:
* Progression of an individual metastasis according to RECIST 1.1 criteria
* Unambiguous development of a new metastatic lesion at least 5mm in size
* Progressive enlargement of a known metastasis on 2 consecutive imaging studies 2- 3 months apart with a minimum 5mm increase in size from baseline
* All sites of oligoprogression can be safely treated
* Maximum 3 progressing metastases in any single organ system (i.e. lung, liver, brain, bone), and the total number of metastases must be 5 or less

Note for Patients with Brain Metastases: For patients with brain metastases and oligo-progression elsewhere where stereotactic radiation to the brain is deemed to be warranted, this must be specified prior to randomization. If randomized to Standard Arm, patient would receive stereotactic radiation to brain only. If randomized to Experimental Arm, patient would receive stereotactic radiation to brain and to body lesions

Exclusion Criteria:

* Serious medical comorbidities precluding radiotherapy, such as ataxia-telangiectasia or scleroderma. For patients with oligoprogressive lesions in the lung or thorax, this includes interstitial lung disease
* Prior radiotherapy to a site requiring treatment
* Malignant pleural effusion
* Inability to treat all sites of enlarging, oligoprogressive disease
* Clinical or radiological evidence of spinal cord compression or tumor within 3mm of spinal cord on MRI
* Any other condition which in the judgment of the investigator would make the patient inappropriate for entry into this study
A Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351

This study evaluates the pharmacokinetics and safety of CPX-351 in patients with moderate or severe renal impairment.


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and voluntarily give informed consent.
2. Male or female patients, age ≥18 years at the time of consent.
3. Diagnosis of hematologic malignancy including, but not limited to, AML, ALL, and MDS. Patients may be newly diagnosed, refractory to initial treatment, or in relapse.
4. Patients with normal renal function, or moderate or severe renal impairment as categorized by creatinine clearance (CrCl)) using the Cockcroft-Gault Formula.
5. Consent of female patients to use a medically acceptable method of contraception for at least 2 months prior to the first dose of CPX-351 and consent of female patients to use a medically acceptable method of contraception throughout the entire study period and for 6 months following the last dose of CPX-351.
6. Male patients must be willing to refrain from sperm donation for 6 months following the last dose of CPX-351and must use adequate contraception throughout the entire study period and for 6 months following the last dose of CPX-351.

Exclusion Criteria:

1. Prior treatment with CPX-351 ≤ to 1 month before the start of CPX-351 in this study.
2. Patients with active (uncontrolled, metastatic) second malignancies are excluded.
3. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent obtaining informed consent.
4. Patients with known hypersensitivity to cytarabine, daunorubicin, or liposomal products.
5. Female patients who are pregnant, nursing, or lactating.
6. Participation in another clinical trial of an investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) prior to enrollment in this study.
7. Any other condition that would cause a risk to patients if they participate in the trial.