cyrilzakka/clinical-trials huggingface dataset:
Antidepressant Response of DMT Masked With Propofol

The aim of this study is to elucidate if the anti-depressive effect of N,N-dimethyltryptamine (DMT) is based on a biological mechanisms including neuroplasticity and anti-inflammatory effect or due to the subjective psychedelic experience.

Major depressive disorder (MDD) affects nearly 20% of people, but current treatments-both pharmacological and psychotherapeutic-have limited efficacy, especially for mild to severe cases. Psychedelics like LSD, psilocybin, and DMT are being explored as alternative therapies, with studies showing promising antidepressant effects. However, it is unclear whether these benefits stem from their acute subjective (psychedelic) experience or from biological mechanisms like neuroplasticity and anti-inflammatory effects.

This study aims to determine if the antidepressant effects of DMT occur independently of its psychedelic experience. To test this, DMT will be administered under sedation (with propofol) to mask subjective effects, as well as without sedation.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must meet DSM-5 criteria for MDD of at least moderate severity (MADRS\>20).
2. Participants either currently do not use antidepressants or are treated with a stable dose for at least 4 weeks prior to randomization.
3. Age ≥ 21 years old.
4. Sufficient understanding of the German language.
5. Able to understand the study procedures and risks and willing to adhere to the protocol and sign the consent form.
6. Willing not to drive or operate heavy machinery on the treatment day.
7. Willing to refrain from more than 7 standard alcoholic drinks a week, more than 10 cigarettes a day, more than 2 cups of coffee a day, and any illicit substances during study participation.
8. Willing to use effective contraceptive measures throughout study participation.

Exclusion Criteria:

1. Past or present bipolar or psychotic disorder, including depressive disorder with psychotic features.
2. First-degree relative with a psychotic or bipolar disorder.
3. Significant prodromal psychotic symptoms (Prodromal Questionnaire-16 symptoms ≥ 6).
4. Borderline personality disorder.
5. Current post-traumatic stress disorder.
6. Post-partum depression.
7. Pregnant or breastfeeding women.
8. Current or recent history of significant suicide ideation or suicide behavior within the past 6 months.
9. Current severe substance use disorder other than nicotine.
10. Planned ketamine, other psychedelic, or electroconvulsive treatment or any such treatment within the past 3 months.
11. Any lifetime use of DMT, use of any other psychedelics within last 3 month or lifetime use of any other psychedelics more than 15 times
12. Patients who are treated with neuroleptics or know antagonists of 5-HT2 receptors or monoamine oxidase inhibitors (MAOI) and are not willing to pause.
A Study on Predictive Model for New-onset Diabetic Foot in Type 2 Diabetes Patients.

A retrospective cohort study was constructed based on hospitalized patients with type 2 diabetes, aiming to explore the related factors for new-onset diabetic foot and conducted a robust prediction model by Cox proportional hazards model.

Diabetic foot is an infection of lower extremity, ulceration and/or deep tissue damage due to neuropathy and varying degrees of vascular disease in diabetic patients, including diabetic foot ulcerations or infections. Diabetic foot can lead to adverse consequences such as amputation and death,which seriously endangering the physical and mental health and quality of life for patients. Early identification of risk factors for diabetes foot is useful to reduce the risk of hospitalization, amputation or even mortality.

Most prediction models for diabetic foot focus on recurrent diabetic foot, however there is little published information on new-onset diabetic foot. This study aims to conduct a retrospective cohort based on Shandong Provincial Qianfoshan Hospital Healthcare Big Data Platform and build a prediction model for the new-onset diabetic foot using the related risk factors, which is of guidance significance for clinical prevention and treatment of diabetic foot.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of type 2 diabetes
2. Hospitalized patients
3. The interval between two records is more than one year

Exclusion Criteria:

1. Any history of ulcer or amputation previously
2. The patients with type 1 diabetes
3. Pregnant during the study
4. Patients with malignant tumors
5. Complicated with serious organ dysfunction, such as heart, liver and kidney
Health Status of Women With Breast Cancer

The quality-adjusted life-year (QALY) is the outcome measure of choice in England and Wales for National Institute for Health and Care Excellence (NICE). To be able to conduct a cost utility analysis, QALY data is required. This can either be collected within trial or published data can be used.

In the United Kingdom (UK) there is no up to date QALY data for women with early breast cancer treated with surgery followed by radiotherapy. The OSTaRa Study aims to provide up to date QALY data for women in this cohort.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Over 18 year of age
* Has had breast cancer, treated with both breast conserving surgery and radiotherapy.
* Is willing to complete an EQ5D and a demographic questionnaire.

Exclusion Criteria:

* Does not speak sufficiently to complete a study questionnaires.
* Has not already been approached to complete an OSTaRa questionnaire.
Comparison of Treatment Outcome of Cabergoline According to Target Prolactin Levels in Patients With Prolactinoma

The aim of this study is to investigate whether inhibition of serum prolactin levels below normal range during cabergoline administration may reduce the recurrence rate after drug withdrawal in patients with prolactinomas.

Prolactinoma patients will be assigned to a experimental group that maintains serum prolactin levels below 5 ng/mL and a control group that maintains normal serum prolactin levels. After that, cabergoline will be maintained at a therapeutic dose for 130 weeks. After cabergoline is discontinued, patients will be followed up with serum prolactin measurement for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults, male or female aged 19 years or older
* diagnosed with prolactinoma
* No previous history of surgery, medication, or radiation therapy

Exclusion Criteria:

* Invasive prolactinomas except invading cavernous sinus
* Taking dopaminergic medications
* Taking medications that can affect serum prolactin level (including estrogenic hormone, oral contraceptive drugs, intrauterine devices)
* Hyperprolactinemia due to secondary causes
* History of pituitary apoplexy within the last 3 months
* Patients with mental illness that should avoid dopamine agonists
* Patients with history of cardiac valve diseases
* Patients with history of pulmonary fibrosis, retroperitoneal fibrosis, and cystic fibrosis
* Moderate degree of hepatic or renal insufficiency (IDMS Modification of Diet in Renal Disease glomerular filtration rate (MDRD GFR) \<45 ml/min/1.73m2)
* Patients with cabergoline hypersensitivity reaction
* Pregnant or breast feeding patients
Effects of Comedy Therapy on Pain and Comfort Levels in Liver Transplant Recipients

This study was conducted to investigate the effects of watching excerpts from classical Turkish comedy films on pain and comfort levels in liver transplant recipients during the postoperative period.

H1-0: Watching classical Turkish comedy films has no effect on postoperative pain in liver transplant recipients.

H1-1: Watching classical Turkish comedy films reduces postoperative pain in liver transplant recipients.

H2-0: Watching classical Turkish comedy films has no effect on postoperative comfort levels in liver transplant recipients.

H2-1: Watching classical Turkish comedy films increases postoperative comfort levels in liver transplant recipients.

Intervention Group A patient introduction form, numerical rating scale and general comfort scale were applied as a pre-test after transplantation surgery. After patients came to the clinic after transplantation surgery and their condition was stable, 10-minute Turkish comedy films prepared by the researchers were shown. After the intervention, a numerical rating scale and general comfort scale were applied as a post-test. While patients watched the comedy films, a quiet and calm environment was provided in the patient room.

Control Group A patient introduction form, numerical rating scale and general comfort scale were applied as a pre-test after transplantation surgery. No intervention was made to the control group patients outside of the clinical protocol. After patients came to the clinic after liver transplantation and their condition was stable, the numerical rating scale and general comfort scale were applied again.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years of age,
* Being a liver transplant recipient,
* Data obtained after transplantation,
* Not having any visual or auditory problems.

Exclusion Criteria:

* Being under 18 years of age,
* Having any visual/auditory problems,
* Not accepting to participate in the study/wanting to leave,
* Not providing hemodynamic instability (sudden change in vital signs, etc.)
Brain Imaging Biomarkers of Pathological Brain Aging in Late-life Depression

This study investigates the relationships and differences in PET-MRI brain imaging biomarkers of abnormal aging and behavioral measures in late life depression compared to healthy controls, and evaluates relationships and differences in the same imaging and behavioral measures following electroconvulsive therapy. The study tests the hypotheses that late-life depression will be associated with higher levels of accelerated aging and brain disease biomarkers, and that electroconvulsive therapy works by stimulating the reorganization of brain tissue.The data collected with contribute to improved knowledge about the neurobiology of late-life psychopathology and its treatment.

This clinical study is a combined single-center, cohort study with a (1) cross-sectional arm evaluating relationships and differences in PET-MR imaging and behavioral measures in 64 patients with late life depression (LLD) compared to 64 healthy controls, and (2) a longitudinal arm evaluating relationships and differences in imaging and behavioral measures in 20 patients receiving ECT as part of their normal clinical management. The study will utilise three PET tracers: (1) \[11C\]UCB-J, which targets the Synaptic Vesicle Glycoprotein 2A receptor, to estimate synaptic density (2) \[18F\]MK-6240, which targets tau associated with neurofibrillary tangles, to assess the presence of tau pathology and (3) \[18F\]-Flutemetamol, which targets beta-amyloid neuritic plaques in the brain, to assess the presence of cerebral amyloidosis. The main aim of the study is to clarify how hippocampal synaptic density, tau, amyloid and white matter lesions, relate to neuropsychological function, stress and ECT in late life depression.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of late-life depression according to DSM 5 (patients only)
* Age over 60 years old
* Judged to be in good physical health by the investigator on the basis of medical history

Exclusion Criteria:

* history or evidence of psychiatric disease, as assessed by clinical interview (healthy controls only).
* history of major other neurological disorder, or major internal pathology that may make him/her unfit for participation according to the interpretation by the investigator (including cardiac, lung, haematological, gastro-intestinal disorders or cancer);
* current user (including ''recreational use'') of any illicit drugs,including cannabis, or has a history of drug or alcohol abuse;
* had exposure to ionizing radiation (\> 1 mSv) in other research studies within the last 12 months;
* has a contra-indication for MRI scanning;
* suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; cannot lie still for 60 minutes inside the scanner;
* does not understand the study procedures
* unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator;
* underwent ECT within the last 3 months before enrollment (patients)
Left Atrial Strain and Supraventricular Arrhythmia Burden in Cardiac Light Chain Amyloidosis Following Chemotherapy

The purpose of this study to assess the longitudinal changes in left atrial strain and supraventricular arrhythmia burden after chemotherapeutic strategies in cardiac light chain amyloidosis.

Light chain (AL) amyloidosis is a disease characterized by localized or systemic accumulation of amyloid fibrils in tissues caused by abnormal folding of light chain immunoglobulins and affecting organ functions. Due to the accumulation of abnormal folding immunoglobulins in the cardiac conduction system, arrhythmia susceptibility has been reported to increase significantly. Atrioventricular blocks and supraventricular arrhythmia are mainly detected among the most common arrhythmia. While these developing supraventricular arrhythmias and atrioventricular blocks in non-amyloidosis diseases result in increased mortality and morbidity, there is insufficient data on cardiac AL amyloidosis treated with chemotherapy. For this reason, this study was planned, and the purpose of this study is to assess the longitudinal changes in left atrial strain and supraventricular arrhythmia burden after chemotherapeutic strategies in cardiac light chain amyloidosis.

After being informed about the study, it is planned to recruit and follow up AL-Amyloidosis patients with cardiac involvement who are currently receiving/planned chemotherapy followed by hematology or who are planned for bone marrow transplantation within one year after obtaining written consent from the patients.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Patients who give the informed consent
* Patients with cardiac primary light chain amyloidosis or due to multiple myeloma who are newly diagnosed, currently receiving chemotherapeutic treatment, or are scheduled for bone marrow transplantation

Exclusion Criteria:

* A history of myocardial infarction, coronary artery disease, percutaneous coronary intervention and revascularization
* \< 18 years old
* A history of severe aortic and mitral valve disease
* Patients who do not give the informed consent
* A history of severe hypertension (SBP\>180 mmHg or DBP ≥110 mmHg or the need to use three or more antihypertensive agents)
* Stable coronary artery patients with ischemia data in stress tests (exertion test, myocardial perfusion scintigraphy)
* Presence of non-amyloidosis, systemic, inflammatory or autoimmune disease
* Patients whose cardiac imaging is not interpretable
* Patients whose ECG is not interpretable
A Post Discharge Intervention to Improve Stroke Outcomes

The purpose of this randomized controlled trial (RCT) is to test the effectiveness of a comprehensive interdisciplinary post-discharge stroke care management intervention in improving the overall well-being of 190 stroke survivors as compared to 190 patients who receive usual post-discharge stroke care.

The major components of the model of post-stroke care being tested include equal emphasis on physical and psychosocial issues known to impact stroke outcomes, an Advanced Practice Nurse care manager (APN-CM), an interdisciplinary healthcare team, evidenced-based care plans, collaboration with the patient's primary care physician (PCP), and ongoing patient monitoring. The APN-CM will work as part of an interdisciplinary post-stroke consultation team (PSC-Team) that will review problems identified at an in-home patient assessment. The core PSC-Team will include a geriatrician, a community-based general internist, a Clinical Nurse Specialist from the acute stroke unit, the APN-CM, and a physical therapist. Extended team members will be available as-needed and will include a neurologist, pharmacist, physiatrist, social worker, speech therapist, occupational therapist, and dietitian. The PSC-Team will develop patient care plans specific to each problem identified by the APN-CM. A copy of the care plans, evidence-based guidelines, pertinent references, and a short paragraph providing "academic detailing" specific to the patient's problems will be given to the patient's PCP by phone and in writing. The APN-CM will work collaboratively with the PCP to implement the recommendations and provide ongoing monitoring.The primary outcome of overall well-being of stroke survivors will be obtained at 6 months.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of ischemic stroke. NIH Stroke Scale score \>1. Discharged to home from the acute care hospital, or discharged to home within 4 weeks from a short term skilled nursing facility (SNF) or acute rehabilitation facility.

Live within 25 miles of the study site. English speaking. Do not have an endarterectomy planned at the time of discharge to home.

Exclusion Criteria:

Has other illness that would dominate post-stroke care (e.g., terminal diagnosis, dialysis patient, severe dementia/Alzheimer's disease).

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BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination

The objective of this clinical study is to evaluate the efficacy and safety by comparing the BR1010 treatment group to the fimasartan/amlodipine treatment group at Week 8 in patients with essential hypertension who do not adequately respond to Fimasartan/Amlodipine combination


Eligibility Criteria:
Inclusion Criteria:

1.Voluntarily provided a written consent to participate in this clinical study 2.19 years old or above Koreans living in Korea 3.Patients with uncontrolled essential hypertension at screening time(Visit 1)

* Use antihypertensive drugs:140 mmHg ≤ sitSBP \< 200 mmHg
* Naïve: 160 mmHg ≤ sitSBP \< 200 mmHg 4.Patients with uncontrolled hypertension after Fimasartan/Amlodipine 30/5mg treatment for 4 weeks at randomization(Visit 2) (Selected Arm:140 mmHg ≤ sitSBP \< 200 mmHg 5.Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion

Exclusion Criteria:

1. Difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in 3 blood pressure measurements in the selected reference arm at the screening visit
2. Blood pressure results showing sitDBP ≥ 120 mmHg at screening and baseline visit(Visit 1; Both Arm, Visit 2: Selected Arm)
3. Treatment Compliance of Fimasartan/Amlodipine 30/5mg \< 70%
4. Heart failure(New York Heart Association class 3 and 4), ischemic heart disease, peripheral vascular disease
5. Percutaneous Coronary Artery within 6 months prior to study
6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
7. Patients who have history of severe cerebrovascular disease within 6 months prior to study
8. Type I Diabetes Mellitus or Uncontrolled Type II Diabetes Mellitus(HbA1c \> 9% at screening visit
9. Patients who have history of severe or malignant retinopathy within 6 months prior to study
10. Pregnant or lactating women
11. Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods
12. Patients taking other clinical trial drugs within 4 weeks from the time of visit for screening
13. Patients who are judged unsuitable to participate in this study by investigator
Optimising Preconceptual Health in Subfertile PCOS Patients Using a Lifestyle Modification Program

Patients will be randomly assigned to a group where they undergo a 12-week lifestyle modification program prior to their fertility treatment, or a group where they are entitled to start their fertility treatment without prior lifestyle modification program.

When allocated to the control arm patients will receive the standard of care combined with the foreseen questionnaires and bio-electric impedance analysis for body composition and ergospirometry. When the patient is allocated to the interventional arm she will receive a 12-week lifestyle modification program prior to her fertility treatment. The lifestyle modification program will consist of dietary advice, advice for physical activity and emotional support. After the 12-week program the fertilty treatment will start as per routine practice. Questionnaires, ergospirometry and bio-electric impedance analysis will also be performed at the foreseen moments.

Eligibility Criteria:
Inclusion Criteria:

* Subfertile patients between \>18- \<38 years old requesting fertility treatment at our centre
* PCOS phenotypes A, B, C and D according to the NIH 2012 extension of the ESHRE/ASRM 2003 diagnostic criteria
* BMI \>27 and \<38 (Jiskoot et al. 2017)
* Nulliparous women
* Patient gives consent voluntarily

Exclusion Criteria:

Patients will be excluded if they:

* do not meet the ESHRE/ASRM 2003 diagnostic PCOS criteria
* Have a BMI \<27 and \>38 (Jiskoot et al. 2017)
* Need Surgical sperm retrieval
* Use donor eggs
* Need Pre-implantation genetic testing (PGT)
* Multiparous women
* cannot reliably fill out the questionnaires or comprehend the intervention, because of a language barrier
Oxygenation and Muscle Function's Relationship During SLIE in Older Adults

This study is to determine the correlations between oxygenation of calf muscles and physical performance including balance, gait speed, and endurance in older adults by utilizing the NIRS device.

The aim of this study is to determine the relationship between oxygenation of calf muscles and physical performance including balance, gait speed, and endurance in older adults by utilizing the NIRS device. The investigators want to determine the relationship between different types of tests and oxygenation for older adults with 4 levels of physical activity. This study will help towards identifying possible short and effective exercises for older adults with different activity levels.

Eligibility Criteria:
Inclusion Criteria:

* individuals who are 60 years old or older
* who are ambulatory with or without a mobility device
* can follow instructions without assistance

Exclusion Criteria:

* having an amputated limb
* current or uncontrolled vestibular disorders
* sensation impairment at the lower extremity
* macular degeneration disease such as glaucoma
* Parkinson's disease
* blood circulation disorders such as chronic venous insufficiency
* individuals without English proficiency