cyrilzakka/clinical-trials huggingface dataset:
BRING-UP Prevention

The aim of this observational study is to assess in patients with a documented athero-thrombotic event: coronary artery disease (CAD), cerebrovascular disease (CVD), peripheral artery disease (PAD):

* the level of adherence to guideline recommendations with the assumption to improve the rate of patients at goal for cholesterol levels.
* the level of adherence to guideline recommendations and the rate of patients at goal for the other relevant and modifiable risk factors for cardiovascular event recurrence.

Observational, prospective, multicenter study conducted in a large, representative sample of Italian cardiology centers.

Phases:

1. First educational intervention to discuss the recommendations of guidelines for secondary prevention strategies.
2. Data collection for 3 months or up to 30 consecutive patients in patients with documented CAD/CVD/PAD on a web Case Record Form (CRF) generating warning on the most relevant guideline recommendations, and, when guidelines are not followed, asking the reason for non-adherence.
3. Evaluation of the primary and secondary end-points of the study at 6 months after enrollment.
4. Second educational intervention to share the results of the first enrollment period of the study focusing the attention on existing gaps between guidelines recommendations and clinical practice.
5. New data collection for 3 months or up to 30 consecutive patients in patients with documented CAD/CVD/PAD on a web CRF generating warning on the most relevant guideline recommendations, and, when guidelines are not followed, asking the reason for non-adherence.
6. Additional evaluation of the primary and secondary end-points of the study at 6 months after enrollment.
7. 12-month follow-up for all patients included in both enrolment phases.

Eligibility Criteria:
Inclusion Criteria:

* Both sexes at birth, age ≥18 years

At least one of the following clinical conditions:

* Documented CAD defined as:

  * Prior Acute Coronary Syndrom (ACS)
  * Prior Coronary Artery Bypass Graft (CABG)
  * Prior Percutaneous Coronary Intervention (PCI)
* Documented PAD (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease, Ankle Brachial Index (ABI)\<90).
* Documented CVD: Ischemic stroke, previous carotid vascular interventions.
* Signed informed consent.

Exclusion Criteria:

* Active neoplasia or very severe disease compromising short-medium term life expectancy.
* Participation in interventional studies.
* Patients already enrolled into the study from another participating center or in the previous enrolling phase.
tDCS and CO-OP in Chronic Stroke

This project seeks to evaluate the acceptability feasibility, practicality feasibility, and preliminary effect of combining transcranial direct current stimulation (tDCS) and metacognitive strategy training (MCST) in individuals with chronic stroke.

Currently seven million people are living in the United States post stroke, making stroke the leading cause of long term disability. Almost half of the people living in the community following stroke have problems that challenge the activities that support their daily lives. This is in part due to the rehabilitation community's focus on short term stroke recovery and not on supporting survivors' need to actively manage their long-term disability and the environment around them so they can return to full participation in communities of their choice post-rehabilitation. The rehabilitation community is in need of evidence-based interventions for addressing post-stroke functional limitations. Metacognitive strategy training is a performance-based, problem-solving approach to task performance difficulties. Participants are taught to identify when to apply a cognitive strategy, how to apply it, and how to monitor and adapt usage of cognitive strategies within task performance. Metacognitive strategy training is recognized as a practice standard for addressing functional limitations post-stroke. Transcranial direct current stimulation is a method that has been used for over 15 years to modulate the excitability of targeted brain regions. While it does not directly stimulate neurons, it results in changes to polarity of neuronal membranes and is thought to facilitate or inhibit neuroplasticity. Combination of these approaches may result in an interaction of effects and a greater effect on function in individuals post-stroke than either approach used alone.

Eligibility Criteria:
Inclusion Criteria:

* \> 6 months post mild to moderate ischemic stroke
* self-reported functional limitations
* Age 30-80

Exclusion Criteria:

* history of other neurological diagnoses
* cognitive impairment (less than or equal to 21 on the Montreal Cognitive Assessment)
* severe aphasia (greater than or equal to 2 on the NIHSS language item
* non-English speaking
* any additional condition where the PI deems participation unsafe
* pregnancy, 7)
* history of seizures
* medications that influence cortical excitability
* metallic implants above the chest
* history of welding or metalwork
* severe depressive symptoms (\>21 on Patient Health Questionnaire)
Extensive Stage Sclc Patients Who Were Benefit From First-line Treatment Accept Temozolomide Maintain Therapeutic

This study evaluates temozolomide maintain therapeutic efficacy and safety in extensive stage SCLC who has clinical benefit from etoposide combined Los platinum (EL) scheme in the first line treatment.

According to the etoposide combined Los platinum (EL) plan administration, every cycle was 21 days, a total of four cycle. The patients who was clinical benefit directly from EL scheme in the first line treatment accept temozolomide maintenance therapy, 150mg / m2, oral D1-5. A period of 28 days, regular follow-up and evaluation of effectiveness, safety and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18 to 70 years old, men and women are not limited;
2. confirmed by histopathological examination SCLC;
3. clinical stage for patients with extensive stage (except for the case of pleural effusion)
4. patients has no drug treatment history
5. the implementation of palliative radiotherapy for metastatic lesions, surgical treatment, after the end of treatment over 14 days.
6. there can be measured lesions (non radiation exposure site) of patients (RECIST) evaluation;
7. physical condition score ECOG PS:0-1
8. more than expected survival time over 3 months

Exclusion Criteria:

1. the previous platinum compounds have a history of allergies;
2. active ulcer patients;
3. Patients with primary lung lesions were treated with radiotherapy;
4. chest X-ray showed clear interstitial pneumonia or patients with pulmonary fibrosis;
5. the need for treatment of brain metastases in the active phase
6. there are more serious tumor invasion, superior vena cava syndrome, or in the middle volume of malignant pleural effusion, abdominal effusion or pericardial effusion, not yet control;
7. there is a serious infection, ADH abnormal secretion syndrome, poor control of diabetes,the need for the treatment of patients with severe complications such as vena cava syndrome
Trust Game and Placebo Response

In the proposed study, investigators aim to investigate the role of interpersonal trust in the conditioned placebo analgesia process with healthy male subjects in a standardized experimental heat pain paradigm.


Eligibility Criteria:
Inclusion Criteria:

* Men: age between 18 and 40 years old
* Healthy by self-report statement, thus no known current or chronic somatic diseases or psychiatric disorders
* Right-handedness (Oldfield, 1971)
* Willing to participate in study

Exclusion Criteria:

* Any acute or chronic disease (chronic pain, hypertension, heart disease, renal disease, liver disease, diabetes) as well as skin pathologies, neuropathies or nerve entrapment symptoms, sensory abnormalities affecting the tactile or thermal modality
* Current medications (psychoactive medication, narcotics, intake of analgesics) or being currently in psychological or psychiatric treatment
* Insufficient German language skills to understand the instructions
* Previous participation in studies using pain assessment (threshold and tolerance) with Peltier Devices
* Daily consumption of more than three alcoholic standard beverages per day (a standard alcoholic beverage is defined as either 3dl beer or 1 dl wine or 2cl spirits
* Current or regular drug consumption (THC, cocaine, heroin, etc.)
Study of CM313 in Subject With IgA Nephropathy

This is a randomized, double-blind, placebo-controlled phase II clinical study evaluating the safety and efficacy of CM313 (SC) in subjects with IgA nephropathy


Eligibility Criteria:
Inclusion Criteria:

1. Able to comprehend the research study and voluntarily signing the informed consent form (ICF).
2. Renal biopsy report supporting diagnosis of primary IgAN within 8 years prior to the screening visit.
3. Estimated glomerular filtration rate (eGFR) \>=30 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2) at screening.
4. Receiving stable background therapy for IgAN (angiotensin-converting enzyme inhibitor \[ACE-I\] or angiotensin receptor blocker \[ARB\]) for 12 weeks prior to screening.

Exclusion Criteria:

1. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies).
2. Known or suspected hypersensitivity to excipients used in CM313.
3. Rapidly progressive glomerulonephritis (RPGN), defined as a decrease of eGFR by more than 50% within 3 months prior to Baseline Visit and/or formation of crescents in more than 50% of glomeruli in renal paracentesis specimens.
4. Confirmed acute kidney injury (AKI) within 4 weeks prior to Baseline Visit.
5. Receipt of live attenuated vaccine within 30 days prior to the Baseline Visit or plan to receive such a vaccine during the study; receipt of novel coronavirus vaccines within 7 days prior to study drug administration.
6. History of transplantation (any solid organ transplant, including renal transplant, bone marrow transplant, etc.) or plan to undergo transplantation during the study.
7. History of severe recurrent or chronic infection.
8. Current malignancy or history of malignancy during the previous 5 years, except adequately treated basal cell or squamous cell carcinomas of the skin or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix.
Effectiveness of Food-grown Magnesium on Sleep Quality/Quantity

This is a double-blind randomised placebo-controlled trial to evaluate orally-dosed food-grown magnesium compared to placebo on improvement in sleep quality and quantity as well as quality of life in otherwise healthy participants aged 18 years and older.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older
* Otherwise healthy
* Disturbed sleeping pattern (defined as difficulty falling asleep, waking up during the sleep cycle or waking up too early and being unable to fall back to sleep)
* Able to provide informed consent
* Agree not to change current diet/exercise or not to use other medicines or supplements for sleep or anxiety other than the test product during entire study period.
* Agree not to participate in another clinical trial while enrolled in this trial

Exclusion Criteria:

* Unstable or serious illness (e.g. serious mood disorders such as depression or bipolar disorder, neurological disorders such as MS, kidney disease, liver disease, GIT conditions, heart conditions, diabetes, thyroid gland function) (1)
* History of renal function impairment
* Regular sleeping pattern
* Current malignancy (excluding BCC) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years
* Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
* Receiving/prescribed sleep or anxiety medication/aid
* Sleep apnea
* Diagnosed or consistent gastrointestinal issues that disrupt sleep
* Active smokers, nicotine use, drug abuse
* Chronic past and/or current alcohol use (\>14 alcoholic drinks week)
* Allergic to any of the ingredients in active or placebo formula
* People with serious mood disorders (such as depression, anxiety and bipolar disorder) will be excluded
* Those suffering from insomnia or have night-shift employment and unable to have a normal night's sleep (2)
* People suffering any neurological disorders such as MS
* Pregnant or lactating woman
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participants who have participated in any other clinical trial during the past 6 months
* Clinically significant acute or chronic inflammation, or connective tissue disease or arthritis
* History of infection in the month prior to the study
* Regularly taking stimulants (e.g., coffee, caffeine supplements, caffeine containing beverages) 2 hours before bed
* Disturbed sleeping pattern caused by external factors (e.g., children, partner, noises)

  1. An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
  2. Insomnia has been excluded as it is a significant health condition, and we are testing on otherwise healthy participants (as per TGA complementary medicine requirements)
Pre-Oxygenation Techniques in Pregnancy

A trial comparing outcomes of two pre-oxygenation techniques in obstetric patients.

Pre-oxygenation is performed prior to general anesthesia to prevent hypoxia during airway management. It is typically performed using a standard tight-fitting face mask; however, recent advances in oxygenation have occurred through the use of trans-nasal oxygen delivery devices, such as OptiFlow. There is limited evidence of the use of OptiFlow in the pregnant patient, and as such, this study aims to show that OptiFlow is as effective at pre-oxygenation as a standard tight-fitting face-mask technique in the pregnant population.

Eligibility Criteria:
Inclusion Criteria:

* Healthy (American Society of Anesthesiologists class 1 or 2), pregnant patients ≥36 weeks gestation scheduled for elective Cesarean delivery under neuraxial anesthesia.

Exclusion Criteria:

* Comorbidities likely to alter outcome of respiration and gas exchange.
* Patients only able to breathe through their mouth.
* Patients who are in active labour.
* Patients unable to tolerate a face mask being held over their mouth and nose.
* Patients with a Body Mass Index ≥40kg/m2.
* Patients who are unable to give informed consent.
Effects of Water and Food Intake on the Pharmacokinetics and Pharmacodynamics of Oral Salmon Calcitonin in Healthy Postmenopausal Women

This is a phase I study to analyze the effect of water and food intake on the bioavailability and pharmacodynamic of oral salmon calcitonin (SMC021) and salmon calcitonin nasal spray in post-menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Healthy postmenopausal women

Exclusion Criteria:

* Previous treatment with other osteoporosis medication

Other protocol defined inclusion/exclusion criteria may apply.
A Study To Assess GW677954 Used In Combination With Insulin In Subjects Who Have Type 2 Diabetes Mellitus

Many drugs used for the treatment of Type 2 Diabetes Mellitus cause the body to retain water. This study will assess whether or not GW677954 causes the body to retain fluid.


Eligibility Criteria:
Inclusion criteria:

* Have been diagnosed by a doctor with Type 2 Diabetes Mellitus at least 3 months before Screening
* Have a body mass index within range 25 to 40.0kg/m2 inclusive
* Females who meet above criteria must be physiologically incapable of becoming pregnant (ie., surgically sterilized, or post-menopausal per protocol definition)

Exclusion criteria:

* Significant weight loss or gain in the 3 months before screening
* Have used insulin to treat hyperglycemia within 3 months before screening
* Have a history of fluid retention
* Have uncontrolled high blood pressure
* Have liver disease
* Take loop diuretics (water pills), certain blood thinners, and/or St. Johns Wort. - Have or have had certain kinds of cancer
Real-world Incidence of Intraocular Inflammation Following Intravitreal Faricimab Therapy

Faricimab (Vabysmo®), a novel pharmaceutical agent is a promising treatment for age-related macular degeneration and diabetic macular edema due to its dual mechanism of action, targeting both the VEGF and angiopoietin-2 (Ang-2) pathways, offering potential benefits in improving visual outcomes and reducing treatment burdens. The phase 3 TENAYA and LUCERNE clinical trials have demonstrated its efficacy and safety profile, leading to regulatory approval and increasing use in clinical practice. However, as with any new therapeutic agent, there is a critical need to monitor and evaluate real-world safety data to complement and validate clinical trial findings.

Intraocular inflammation (IOI), which is a significant adverse effect of intravitreal anti-VEGF injections, is of particular interest as it can vary from a mild transient reaction to a potentially vision-threatening outcome.

The incidence and severity of IOI in a real-world settings can vary from clinical trial results due to differences in patient populations, injection techniques, and clinical settings.

The aim of this study is to estimate the real-life incidence of intraocular inflammation following intravitreal faricimab injections at a large, regional highly specialized tertiary center.


Eligibility Criteria:
Inclusion criteria

* \>18 years of age
* Having received at least 1 intravitreal faricimab injection at our center
* Follow-up period of at least 6 weeks after the injection

Exclusion criteria for IOI cases

* Having received intravitreal injections of other types (e.g., intravitreal steroids, antiviral agents) at the same time as the intravitreal anti-VEGF injection or during the follow-up period
* Underwent intraocular surgery within 6 weeks before or after the intravitreal injection, except for surgical interventions that are meant to diagnose or treat the actual IOI in question (e.g., diagnostic chamber tap, diagnostic vitrectomy, vitrectomy for suspected endophthalmitis, etc.)
Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model

The goal of this study is to establish a novel community-based breast cancer program to address delayed presentation and lack of access to diagnostic and treatment facilities in South-West Nigeria. It is aimed at evaluating the impact of a novel breast cancer early detection program using triple mobile assessment (innovative handheld iBreast Exam \[iBE\] device, mobile ultrasound, and mobile mammography) and patient navigation program in a Nigerian community.

This study aims to provide screening to asymptomatic women 40-70 years and to provide diagnostic evaluation to women 30-70 years presenting with breast symptoms in a community in South-West Nigeria.

The project will use a cluster randomized design with 1 community serving as the intervention arm and another community serving as the control arm. Both communities will receive breast cancer awareness and education but only the intervention community will receive screening, mobile imaging and navigation. Screening with targeted clinical history, Clinical Breast Exam (CBE), and iBE will be performed by trained Community Health Nurses in the intervention community. Women with positive CBE or iBE findings will undergo breast imaging with mobile mammography and portable ultrasound, as well as biopsy when indicated by the Radiologist who visits the community once a month, and receive navigation by the nurses to the point of care. The control population will receive breast cancer awareness without an organized screening, imaging or navigation program. Women presenting to the Primary Health Care Centers in the control community will be referred to the Teaching Hospital as per current standard of care. Record of all breast cancer cases seen in the 2 communities during the study period will be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic women 40 - 70 years
* Symptomatic women (with breast-related symptoms) 30 - 70 years

Exclusion Criteria:

* Male subjects
* Women living outside the study locations (Ife East and Ife North districts)
Comparison of Glycaemic Fluctuation and Oxidative Stress Between Two Short-term Therapies for Type 2 Diabetes

The purpose of this study is to compare the blood glucose control, glycaemic fluctuation and oxidative stress for Type 2 Diabetes between two therapies, one is glargine combined with oral drugs and the other is continuous subcutaneous insulin injection.

This study was a single-center, randomized, controled and prospective trial. Type 2 diabetic patients were randomized into 2 groups (Group A and Group B). Subjects in group A would be treated by using continuous subcutaneous insulin injection with insulin lispro, while subjects in group B would be treated by using glargine with oral drugs (metformin and gliclazide modified release tablets). After achieving the target glucose levels by two different approaches in 3-5 days, maintain the target glucose level for 3-5 days. Then a Medtronic dynamic blood glucose meter would be applied to the subjects for 72 hours. The clinical data, such as demographic information, present history, past history, personal history and so on were collected in the 1st day. In the 2nd day and the last day of the trial, the blood samples of the patient were collected for the Laboratory Measurements: Cr, uric acid, aminotransferase, lipid profiles, white blood cell count, N%, fasting plasma glucose, fasting C-peptide, insulin, HbA1c and standard meal test (0.5h-postprandial and 2h-postprandial blood glucose levels, C peptide and insulin, et al. The parameters of b-cell function and glycemia fluctuation were calculated and then analyzed by spss 13.0.

Eligibility Criteria:
Inclusion Criteria:

1. investigator diagnosed type 2 diabetes( 1999 WHO diagnosis criteria).
2. diagnosed as type 2 diabetes in the first time without drug therapy, or type 2 diabetes does not accept insulin in the near 3 month and duration is shorter than 10 years
3. Fasting plasma glucose ( FPG ) ≥11.1mmol/L or glycated haemoglobin (HbA1c )≥9%.
4. agree to participate the study and sign the informed consent.

Exclusion Criteria:

1. obvious failure of heart, hepatic, kidney function.
2. severe acute or chronic complications, associated diseases. or other diseases that should not use oral hypoglycemic drug.
3. women in pregnancy or planning to get pregnancy.