cyrilzakka/clinical-trials huggingface dataset:
Depot-medroxyprogesterone Acetate (DMPA) Contraceptive Method and Metabolism

Objective:

The purpose of this study is to determine the etiology of the weight increase in Depot-medroxyprogesterone Acetate (DMPA) users.

Method:

Prospective study with 100 women, aged 18-40 years old and BMI \< 30kg/m², paired with users of a non hormonal method follow for two years. Will be included only women who never used DMPA. There will be evaluated habit, blood pressure, anthropometric measure, distribution of corporal fat, lipids profile and glycemia parameters every six months. Thirty women and their control group will performed a euglycemic-hyperinsulinemic clamp to evaluate the resistance of insulin, adiponectin,neuropeptide Y, apolipoprotein A/B and arterial evaluation with ultrasound, intimal and media measure. Anova analysis for repeated samples. The metabolic alterations should elucidate the etiology, and the beginning of the sub clinical cardiovascular disease should be shown/discarded with the arterial evaluation.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* new users of DMPA
* BMI\<30kg/m²

Exclusion Criteria:

* diabetes mellitus and 2 present or fasting glucose\> 100mg/dl and / or blood glucose\> 140mg/dl after ingestion of 75mg of oral glucose
* first-degree relatives with diabetes mellitus
* period of lactation
* hypertension, with or without treatment
* hyper and hypothyroidism
* chronic renal failure
* transplant of any organ
* women using drugs that may be related to weight gain and / or development of insulin resistance and chronic use of corticosteroids, antipsychotics, statins, and thiazide,
* hirsutism and/or hyperandrogenism
* polycystic Ovary Syndrome (PCOS)
* women with acanthosis nigricans
* women who have used depoprovera at some point in their reproductive lives,
* women who have performed bariatric surgery
Trunk Forward Ability in Patients With Lumbar Fusion

The hypotheses of this study are as follows:

1. There is no significant muscle activity difference of each muscle in patients between pre and post operation.
2. There is no significant forward reach distance/average velocity difference in patients between pre and post operation.
3. There is no significant standard deviation of center of pressure (COP) along x axis, speed of COP along y axis during the task and COP path during the 3-sec holding phase difference in patients between pre and post operation.
4. There is no significant muscle activity difference between muscles on both sides at post operation.

30 healthy adults and 30 patients is going to undergo lumbar fusion surgery will be recruited in this study. The assessment will be held before surgery, two months, three months and six months after surgery. Visual pain scale and passive range of motion over lumbar, hip, knee, ankle joint of each subjects will be recorded. Then the maximum voluntary contraction at lower extremity will be measured by electromyography. Finally, the subjects will be asked to do forward reach by dominant upper limb/bilateral upper limbs/arm crossed in the front of chest for three times in standing and sitting position after five practices. The motion data will be collected by 3-dimension video and the muscle activity by electromyography.

Eligibility Criteria:
Inclusion Criteria:

1. specific low back pain with MRI finding by the radiologist and the surgeon;
2. patient who is scheduled for MISS in one week.

Exclusion Criteria:

1. scoliosis;
2. neurological disorder;
3. Self-reported impairment in daily activities;
4. leg length deficiency over 2 cm;
5. body mass index over 30.
Behçet and LDH/Albumin

ABSTRACT Objective: To investigate whether the lactate dehydrogenase to albumin ratio can be used as a parameter to determine disease severity in Behçet's disease, an inflammatory disease, by comparing it to healthy controls.

Patients and Methods: In this retrospective cohort study, patients with Behçet's disease aged 18-69 years who presented to the outpatient clinic between February 2020 and April 2023 and healthy individuals of similar age and gender were enrolled. LDH, albumin levels, and LDH/albumin ratio of both groups were compared. Clinical findings and characteristics of Behçet's patients and disease severity were recorded and analyzed in relation to LDH/albumin ratio.


Eligibility Criteria:
Inclusion Criteria:

Patients with Behçet's disease aged 18-69

Exclusion Criteria:

* younger than 18 years or older than 69 years, pregnant and lactating patients, patients with acute infection on admission or nutritional problems, symptomatic gastrointestinal symptoms, malignancy, hepatitis or liver disease were excluded.
The Efficacy of an Artificial Intelligence Platform to Adapt Visual Aids for Patients With Low Vision: a Randomised Controlled Trial

According to the WHO's definition of visual impairment, as of 2018, there were approximately 1.3 billion people with visual impairment in the world, and only 10% of countries can provide assisting services for the rehabilitation of visual impairment. Although China is one of the countries that can provide rehabilitation services for patients with visual impairment, due to restrictions on the number of professionals in various regions, uneven diagnosis and treatment, and regional differences in economic conditions, not all visually impaired patients can get the rehabilitation of assisting device fitting.

Traditional statistical methods were not enough to solve the problem of intelligent fitting of assisting devices. At present, there are almost no intelligent fitting models of assisting devices in the world. Therefore, in order to allow more low-vision patients to receive accurate and rapid rehabilitation services, we conducted a cross-sectional study on the assisting devices fitting for low-vision patients in Fujian Province, China in the past five years, and at the same time constructed a machine learning model to intelligently predict the adaptation result of the basic assisting devices for low vision patients.


Eligibility Criteria:
Inclusion Criteria:

* Low vision Aged 3 to 105

Exclusion Criteria:

* Severe systemic diseases Failure to sign informed consent or unwilling to participate
Alteplase Treatment in Elderly Acute Ischaemic Stroke (AIS) Patients

The objective of this study is to find out if Chinese Acute Ischaemic Stroke (AIS) patients older than 80 years benefit from intravenous (IV) Recombinant Tissue Plasminogen Activator (rt-PA) treatment within 4.5 hours of symptom onset in a real-world clinical setting.


Eligibility Criteria:
Inclusion criteria:

* Patients registered in the Zhejiang Stroke Quality Control Centre (ZSQCC) platform from Jan 2017 to Mar 2020
* \> 80 years of age
* Diagnosed with AIS at admission
* Arrived or admitted to the hospital within 4.5 hours of symptom onset
* If treated with IV rt-PA: received IV rt-PA within 4.5 hours of symptom onset

Exclusion criteria:

* Documented Intravenous Thrombolysis (IVT) contraindication except age to IV rt-PA treatment according to the Summary of Product Characteristics (SmPC)
* Missing any one of the key data (age, gender, baseline National Institutes of Health Stroke Scale \[NIHSS\], time of symptom onset, time of hospital arrival or admission, IVT or not, time of IV rt-PA treatment)
* Received thrombolysis agents other than rt-PA (urokinase, tenecteplase, recombinant plasminogen activator, prourokinase, streptokinase)
* Received endovascular treatment
* Received IV rt-PA after 4.5 hours of symptom onset
Incretin Effect and Use After Clinical Islet Transplantation

We aim to study if the administration of medications to increase the secretion of hormones from the intestines can improve glycemic control, reduce insulin use and promote β-cell regeneration/expansion in subjects with type 1 diabetes following islet transplantation who are back using small doses of insulin because of early graft dysfunction. We believe that the results will enable us to understand whether these drugs could be useful in islet transplant recipients, particularly if glycemic control deteriorates.

This is a single centre non-randomized pilot study. Subjects will be recruited from the current cohort of islet transplant recipients at the University of Alberta.

The primary objective of the study is to evaluate whether the combination of sitagliptin and pantoprazole can restore insulin independence in previously insulin independent islet transplant recipients experiencing early graft dysfunction. The study will also evaluate the safety of the combination drug therapy.

Eligibility Criteria:
Inclusion Criteria

Subjects must meet the following criteria to be enrolled in this study:

1. Male or female, aged 18 to 70, inclusive, who is a previous islet transplant recipient (at least 3 months since last islet transplant) and who received their transplant at the University of Alberta.
2. Insulin independent for 3 months or longer after islet transplant.
3. Early graft dysfunction as defined by:

   1. HbA1c \>6% (but less than 7.5%); or
   2. fasting glucose \> 7 mmol/L (126 mg/dl); or
   3. random glucose \> 10 mmol/L (180 mg/dl), and
   4. Total insulin use of \< 10 units/day.
4. C-peptide positive.
5. Able to provide informed consent.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from the study:

1. Unable to provide informed consent.
2. Prior therapy with sitagliptin or a proton pump inhibitor in the preceding 2 months.
3. Vulnerable populations (i.e. cognitively impaired, pregnant women, residing in institutions, University of Alberta students or employees under the supervision of any of the investigators).
4. Children, adolescent or patients with a "contraindication" or "warning" listed in the package insert of any of the study drugs:

   1. Hypersensitivity to sitagliptin or pantoprazole for any component of the formulation.
   2. Renal disease or renal dysfunction (as suggested by serum creatinine levels ≥ 136 µmol/L (males), ≥ 124 µmol/L (females) or abnormal creatinine clearance; or estimated by Glomerular Filtration Rate (GFR) \<50 ml/min/1.73m2).
   3. Acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).
5. Uncontrolled hyperglycemia
6. Any subject that in the opinion of the investigator would not be a good candidate for study participation.
Clinical Application of ctDNA in Early Screening of Breast Cancer

The investigators aim to evaluate the possibility of clinical application of ctDNA detection in peripheral blood of normal people, benign breast disease patients and breast cancer patients, so as to act as the new techniques or indicators of early screening of breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures.
* Age of at least 18 and at most 70 years.
* Normal people who works as the volunteers.
* Benign breast disease patients should be diagnosed with confirmed pathology after surgery.
* Breast cancer patients should be diagnosed with confirmed pathology after surgery, and with no clinical evidence of local recurrence or distant metastases. Complete staging work-up within 3 months prior to registration, which should be earlier than TNM IIA stage.
* Adequate organ function including normal red and white blood count, platelets, serum creatinine, bilirubin, and transaminases within normal range of the institution.

Exclusion Criteria:

* Known hypersensitivity reaction to the investigational compounds or incorporated substances.
* Local recurrence and/or metastasis of breast cancer.
* Pregnant or lactating patients. Patients of childbearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to registration.
* Prior or concomitant secondary malignancy (except non-melanomatous skin cancer or carcinoma in situ of the uterine cervix).
* Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study.
* Concurrent treatment with other experimental drugs or any other anti-cancer therapy.
* Males.
A Study of Artificial Intelligence ECG With ECG Devices to Detect Hypertrophic Cardiomyopathy Distinct From Athlete's Heart

The purpose of this study is to evaluate the AI-ECG algorithm for HCM in detecting HCM and in differentiating it from athlete's heart using not only the standard 12-lead ECG, but also ECGs obtained with the Apple Watch and Alivecor KardiaMobile devices.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinically validated diagnoses of HCM (n=150) and athlete's heart (n=150) will be identified by pre-screening of the clinic appointments for each of the specialty HCM and Sports Cardiology clinics or in the CV fellows' clinic (in patients with an established diagnosis and no pending testing). All diagnoses will need to be supported by unequivocal imaging and other ancillary data per our standard of care and at the determination of clinic experts.

Exclusion Criteria:

* Any exception to the above criteria.
Positron Emission Tomography (PET) Study With [11C]AZD2995 and [11C]AZD2184, Candidate PET Ligands for β Amyloid

The study is carried out in order to investigate if \[11C\]AZD2995, compared to \[11C\]AZD2184, is a more suitable PET ligand for in vivo imaging of β amyloid depositions in the human brain. In the study the two PET ligands will be examined in both healthy volunteers and patients with Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

* Alzheimer´s Disease patients - 50-85 years- mild to moderate AD, clinical progression of AD over 12 months.
* Healthy male volunteers: - Age 20-50 years, Body Mass Index: 18-30 kg/m2.
* Clinically normal physical findings including normal blood pressure and pulse rate.

Exclusion Criteria:

* Alzheimer´s Disease patients:
* significant cerebrovascular disease or depression, central nervous system infarct or infection or lesions
* clinically significant illness within 2 weeks before the study start.
* administration of any investigational product with effect on brain beta amyloid levels within 3 months prior to study and/or participation in a PET investigation other than study D0180C00011 as part of a scientific study during the past 12 months,.
* Healthy volunteers; - clinically significant illness within 2 weeks before the study start, history of psychiatric or somatic disease/condition that may interfere.- first degree relative with dementia. Obvious deterioration of memory functions.
Crushed Ticagrelor Versus Eptifibatide Bolus + Clopidogrel

Patients with troponin-negative acute coronary syndrome (ACS) are not routinely pre-treated with P2Y12 inhibitors and the rate of high on-treatment platelet reactivity (HPR) remains elevated after a loading dose of ticagrelor at the time of percutaneous coronary intervention (PCI). This suggests that faster platelet inhibition with crushed ticagrelor , eptifibatide , or cangrelor is needed to reduce HPR and periprocedural myocardial infarction and injury (PMI). The present study compared the effects of crushed ticagrelor vs. eptifibatide bolus + clopidogrel in troponin-negative ACS patients undergoing PCI.

Platelet activation and accumulation causes the formation of blood clots that may cause heart attack. As a standard of care, the doctor can prescribe medications such as are ticagrelor, eptifibatide, clopidogrel, to prevent the formation of blood clots.

100 patients with unstable angina, both male and female, will be randomized to either Group A- Crushed Ticagrelor or Group B- Eptifibatide bolus +Clopidogrel administrated immediately before PCI. Platelet function testing, troponin, and ECG will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unstable angina/troponin negative ACS.

Exclusion Criteria:

1. need for oral anticoagulation therapy (Warfarin, Dabigatran, Rivaroxaban, Apixaban, Edoxaban)
2. increased risk of bradycardia, and the associated therapy with a strong cytochrome P-450 inhibitors (anti-retroviral agents, antifungal agents and some antibiotics eg. Indinavir, Nelfinavir, Lopinavir, Ritonavir, Itraconazole, Ketoconazole, Voriconazole, Clarithromycin, Telithormycin)
3. surgery\<4 weeks
4. use of any thienopyridines (Clopidogrel, Prasugrel) 7 days prior to randomization
5. administration of GP IIb/IIIa inhibitors
6. bleeding diathesis or major bleeding episode within 2 weeks
7. thrombocytopenia (Platelet count \< 100000)
8. incessant chest pain
9. hemodynamic instability (Mean arterial pressure \< 65 mm Hg; need for vasopressor or inotropic agents; need for mechanical circulatory support for coronary intervention), NSTEMI as evidenced by elevation of troponin levels (Troponin \> 0.034 ng/ml); renal failure with a serum creatinine \>2.0 mg/dL
10. anemia with HCT\<30%.
Risk Factors in Tachycardiomyopathy

Decision between rate control and rhythm control can be a challenge in clinical practice. While there is some guiding evidence, we still lack a comprehensive insight into different subgroups of patients that will benefit from a rhythm control treatment.

EMPATHY is a prospective clinical study in patients presenting with heart failure and a tachyarrhythmic rhythm disturbance. Biomarkers, routinely obtained results from clinical examinations, and results from endomyocardial biopsies shall be evaluated to identify patients which have better outcome from a rhythm control strategy by ablation therapy or, if contraindicated by pharmacological rhythm control.

This study is designed to identifying risk factors and subgroups profiting from rhythm restoration and therefore improve current therapeutic approaches and the rate of recurrence-free survival.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed left ventricular ejection fraction ≤ 50%
* endomyocardial biopsy available
* tachycardic rhythm disturbance with a rhythm control strategy planned for tachycardic atrial fibrillation or flutter (≥100/min) or more than 10000 ventricular premature beats in 24 hours

Exclusion Criteria:

* age \<18 years
* patient unable or unwilling to give informed consent
* coronary artery stenosis \>50%
* relevant valvular disease
* simultaneous contraindications against amiodarone treatment and pulmonary vein isolation/ablation therapy
* present or suspected alcohol/drug dependency will result in exclusion from the study
Clinical Evaluation of Aromatic Wentong in the Treatment of Coronary Microvascular Disease

Coronary Microvascular Disease (CMD) is a condition where patients experience chest pain (angina) even though their coronary arteries appear normal on angiography. It is common among people with coronary heart disease, especially those with chest pain as their main symptom. Unfortunately, there are no effective treatments available for these patients, and symptoms like chest tightness and persistent pain greatly affect their quality of life.

Traditional Chinese Medicine (TCM) suggests that the root cause of microvascular disease is blocked collateral blood vessels. Aromatic Wentong, a TCM approach, aims to improve blood flow and relieve blockages. Kuangxiong Aerosol is a Chinese patent medicine developed based on the principles of Aromatic Wentong.

This study is a multicenter, randomized, double-blind, placebo-controlled trial involving 528 patients with chest pain and suspected CMD. Participants are recruited from several hospitals, including China-Japan Friendship Hospital, Fuwai Hospital, and Xiyuan Hospital. Patients are randomly divided into two groups:

The intervention group receives standard guideline-recommended treatment plus Kuangxiong Aerosol.

The control group receives standard treatment plus a placebo version of Kuangxiong Aerosol.

The treatment lasts for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 80 years, regardless of gender.
* Clinical symptoms of myocardial ischemia.
* Objective evidence of myocardial ischemia, including:

  1. ECG changes during chest pain episodes,
  2. Stress test-induced chest pain symptoms and/or abnormal myocardial blood flow and/or abnormal cardiac wall motion with ischemic ECG changes.
* Coronary angiography (CAG) showing \>50% reduction in the diameter of the epicardial coronary artery.
* QFR \> 0.80 and AMR \> 2.5 mmHg·s/cm.
* Discontinuation of all Chinese medicine interventions for at least two weeks prior to enrollment.
* Provision of informed consent and a signed informed consent form.

Exclusion Criteria:

* Significant liver or kidney dysfunction, defined as ALT, AST, or blood creatinine levels \>3 times the upper limit of normal.
* Severe cardiac conditions, including heart failure, myocarditis, cardiomyopathy, acute pericarditis, structural heart disease.
* Severe systemic diseases, such as severe mental illness, hematopoietic system disorders, or malignant tumors.
* Suspected or confirmed allergy to the trial drug.
* Individuals deemed by researchers to be unsuitable for participation in the clinical trial.
* Women who are pregnant, planning to become pregnant, or currently lactating.
Research Participants' Views on the Ethics of Clinical Research

This pilot study will explore the usefulness of a series of questions asking about views of research from the perspective of minority and economically disadvantaged research participants. Racial and ethnic minorities are consistently under-represented in clinical research. This under-representation has been attributed primarily to an unwillingness to participate in research because of mistrust in the research establishment, especially in light of widely known historical examples of abuse. However, more recent data suggests that not being invited to participate in research, or stringent entry criteria, may contribute substantially to the low numbers of ethnic minority research participants. The perspectives of racial and ethnic minorities who are knowledgeable about or participating in research are important to understanding the kinds of vulnerabilities that exist and any important barriers to participation.

People 18 years of age and older from the Cardozo clinic in Washington, D.C., who are enrolled in the National Institute of Arthritis and Metabolic Studies' natural history study are eligible to participate in this protocol.

Participants are interviewed with questions about their own experiences in clinical research as well as some hypothetical research studies. Questions include participants' general views of clinical research, perceived risks and benefits of research, alternatives to research participation, the limits of what they would be willing to accept in research and types of research or research procedures they might perceive as unfair.

In an effort to better understand ethical concerns about clinical research, this pilot study aims to explore the utility of a series of questions asking about views of research from the perspective of minority and economically disadvantaged research participants. Cognitive interviews will be conducted in English and Spanish with 10 participants of the NIAMS CHC at the Upper Cardozo Clinic in Washington DC. The interviewer will ask participants about their own experiences as well as some hypothetical research studies. Questionnaires will ask participants about their general views of the clinical research, perceived risks and benefits of research, alternatives to participation, the limits of what they would be willing to accept in research and types of research or research procedures they might perceive as unfair.

Eligibility Criteria:
* INCLUSION CRITERIA:

Adults (18 years and older) from Cardozo clinic who are enrolled in the NIAMS natural history study will be invited to participate in this interview study. The sample will include men and women who are primarily African American and Hispanic. Participants will be eligible if they are able and willing to give informed consent and can participate in an interview in English or Spanish.