cyrilzakka/clinical-trials huggingface dataset:
Bioavailability Study to Compare Liquid vs Two Solid Formulations of IP2015

The study's primary objective is to determine the bioavailability of two solid formulations of IP2015 compared to a liquid formulation of IP2015 in healthy male subjects

It is planned to include 12 subjects. Each subject will take part in three treatment periods, in which they will receive a single dose of IP2015 liquid and then to different IP2015 solid formulations, respectively, in each treatment period. Overall, each subject will receive each treatment once only.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive.
* Subject is ≥50 kg.
* Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examination, concomitant medication, vital signs, 12-lead ECG, clinical laboratory evaluations.

Exclusion Criteria:

* Any significant CNS, cardiac, pulmonary, metabolic, renal, hepatic (including Gilbert's syndrome), gastrointestinal (GI) or psychiatric conditions, or history of fainting or syncope or such condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk as a participant in the study, may interfere with the interpretation of safety or tolerability data obtained in this study, or may interfere with the absorption, distribution, metabolism or excretion (ADME) of drugs, or with the completion of treatment according to this Protocol.
* Clinically relevant history of abnormal physical or mental health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \[but not limited to\], neurological, psychiatric, endocrine, cardiovascular, respiratory, GI, hepatic or renal disorder).
* Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting

Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment of AF is one of the best way to prevent stroke. The problem is that because AF may cause minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is known that as many as half of all patients with known AF may not be receiving appropriate anticoagulation for their condition. New technologies are making it possible to improve AF detection. Subjects in this study will be screened for AF using three simple methods: a 30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood pressure monitor with built-in AF screening capabilities. If more patients with AF can be detected, more patients will be able to receive guideline-recommended anticoagulant therapy, and more strokes, deaths, disability, and dementia will be prevented.

Participants will be screened for AF using three simple methods (pulse check, single-lead ECG, blood pressure machine with automated AF detection algorithms). Subjects screening positive on any test will attend for a 12-lead ECG within 24 h. For all patients with AF detected, clinical characteristics and medications will be compared at baseline and 90±14 days later.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥65 years.
2. Attending their usual Primary Care Clinic.
3. Provide written informed consent.

Exclusion Criteria:

1. Patients considered by the Investigator to be unsuitable for study follow-up because the patient:

   1. is unreliable concerning the follow-up schedule
   2. cannot be contacted by telephone
   3. has a life expectancy less than the anticipated study duration due to concomitant disease.
2. Presence of an implanted pacemaker or defibrillator.
3. Inability to have a BP cuff applied.
4. Documented significant allergy to ECG electrode adhesive.
5. Previously screened as part of this study.
Effects of Core Stabilization and Inspiratory Muscle Training in Patients With COPD

In Chronic Obstructive Pulmonary Disease (COPD), a mismatch develops between the respiratory system's demand and the functional capacity of respiratory muscles due to the combination of local and systemic factors increasing the respiratory workload. This results in impaired coordination of muscle groups, leading to muscle dysfunction. Respiratory muscle dysfunction is a significant determinant of life expectancy in COPD. Additionally, respiratory muscles unable to cope with increased workloads lead to impaired respiratory functions and reduced exercise capacity.

It is widely accepted that appropriate training of respiratory muscles can increase their strength, endurance, and their close relationship with lung volume capacities. Besides their role in respiration, respiratory muscles also contribute to postural function and core stabilization. Studies on respiratory muscle training in COPD have primarily focused on inspiratory muscle strength training, neglecting the core stabilization function of respiratory muscles. However, optimal gains in a muscle can only be achieved with training tailored to its functional characteristics. Therefore, a comprehensive training program should be developed considering the multifunctional nature of respiratory muscles. Studies published in healthy individuals and different patient populations demonstrate that core training can improve lung functions. The aim of this study is to compare the effects of inspiratory muscle training and core stabilization training on diaphragm activation, inspiratory muscle strength, functional capacity, respiratory functions, physical activity, and quality of life in individuals with COPD.


Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Having a diagnosis of COPD according to the GOLD criteria and being at stage 3 or lower
* Not being in an acute exacerbation period and having at least one month since the last exacerbation
* Being able to walk independently
* Having sufficient mental capacity to understand the tasks in the study (Mini-Mental Test \>24)
* Being willing to participate in the study

Exclusion Criteria:

* Being a stage 4 COPD patient according to the GOLD criteria
* Having a diagnosis of lung cancer, pulmonary hypertension, and heart failure
* Being in a COPD exacerbation period
* Scoring below 24 on the Mini-Mental Test
* Having any other disease that affects respiratory functions
* Having undergone pulmonary surgery
Nutrigenomics Diet Intervention Study Comparing Effects of Western and Balanced Diet in Healthy Subjects

Diet macronutrient relative composition, quality and quantity determines lifestyle disease, including cardiovascular disease, development. Our hypothesis is that a high content of carbohydrates in the diet contributes to increased insulin level. Moreover, activating enzymes promoting inflammatory processes and possibly chronic disease development in the body.

The most frequent cause of death in both women and men in the western world is cardiovascular artery disease (CAD). Well accepted as a lifestyle disease, known risk factors for CAD development include changes in blood lipid content and type as well as micro inflammation in the arterial wall. Low density lipoprotein (LDL) and triglycerides are increased, high density lipoprotein (HDL) is reduced. Furthermore, type II diabetes, metabolic syndrome, hypertension, overweight, reduced physical activity and smoking also precede CAD development. Common for many of the risk factors is that they are induced by improper diet. Recent research has shown that especially total amount, composition and quality of the macro nutrients, protein, carbohydrate and fats, is important. In this project we will explore changes in blood gene expression in response to a western and a balanced crossover diet intervention.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* BMI 24.5-27.5
* pass health check criteria

Exclusion Criteria:

* chronic diseases
* inflammation
* pregnancy and lactation
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction

This study is designed to allow existing investigators continued access to the AeroForm Tissue Expander to treat patients while AirXpanders completes a marketing application and during the review process by FDA.

This is a prospective, multi-center, single arm, open-label, continued access clinical study. Subjects who meet the inclusion criteria and agree to participate in the study will be enrolled and implanted with the investigational AeroForm Tissue Expander. If the subject is having a bilateral procedure, the AeroForm expander will be implanted in each side. Subjects will be followed until the first post-operative visit after explant of the tissue expander(s) and exchange for permanent implant(s).

Eligibility Criteria:
Inclusion Criteria:

* Subject is female between the ages of 18-70
* Subject requires tissue expansion as part of breast reconstruction
* Subject is able to provide written informed consent
* Subject is able and willing to comply with all of the study requirements
* Subject has the physical, perceptual and cognitive capacity to understand and manage the at home dosing regimen

Exclusion Criteria:

* Subject's tissue integrity is unsuitable for tissue expansion
* Subject has residual gross malignancy at the intended expansion site
* Subject has current or prior infection at the intended expansion site
* Subject has a history of failed tissue expansion or breast reconstruction
* Subject has any co-morbid condition determined by the Investigator to place the subject at an increased risk of complications (e.g., severe collagen vascular disease, poorly managed diabetes)
* Subject is taking any concomitant medications determined by the Investigator to place the subject at an increased risk of complications (e.g., Prednisone, Coumadin).
Efficacy and Safety of Salvianolate Injection in Elderly Patients With Unstable Angina Pectoris

This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris.

This parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris. Patients will treated with or without salvianolate injection on the basis of conventional therapy for 14 days. The primary measures of effectiveness include the change from baseline to the end of treatment in the angina scores.(Angina score table :sum of 4 items), the variation of EKG (level of the S-T segment)., Additional measures of effectiveness include the change from baseline to the end of the treatment in the Seattle Angina Questionnaire(SAQ),EuroQol-5 Dimensions(EQ-5D) will be performed throughout the study. Patients who complete the double-blind portion of the study will be followed up 28 days. Effectiveness will be assessed at 7 days, 14 days and 28 days. Safety evaluations (incidence of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days, 14 days and 28 days of the study.

Eligibility Criteria:
inclusion criteria

1. Patient in line with 1979 WHO diagnostic criteria for UA
2. Ages eligible for study: 60-85years (adult,senior)
3. Traditional Chinese medicine for CHD treatment should be stopped at least 1 week;take CHD drugs standardly
4. Participates give written informed consent

exclusion criteria

1. NSTE-ACS caused by non atherosclerotic disease
2. Angina pectoris caused by violent activities, fever, tachycardia, high adrenergic state, mental stress, lack of sleep, eating too full, left ventricular load increased (hypertension, aortic stenosis)
3. Angina pectoris caused byanemia, methemoglobinemia and hypoxemia
4. Abnormal thyroid function
5. Poorly controlled hypertension (systolic pressure ≥160mmHg or diastolic blood pressure ≥100mmHg)
6. Severe cardiopulmonary dysfunction
7. Severe arrhythmia (atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, sinus bradycardia (heart rate \< 55),complete left bundle branch block
8. Combined liver and kidney and hematopoietic system and other serious diseases, liver function (ALT, AST) 3 times higher than the upper limit of normal renal function, creatinine clearance rate (CrCl) less than 30 ml/min/1.73m2
9. Recent 4 weeks underwent surgery and bleeding tendency
10. Poor compliance
11. At the same time in other clinical researches
12. Allergic constitution
National Inferior Vena Cava (IVC) Filter Registry

Inferior vena cava (IVC) filter is an important therapeutic device used in the management of venous thrombo-embolism (VTE) in patients that are contra-indicated for anti-coagulation therapy. While there has been significant increase in the use of filters , unfortunately there are no standardized collection of data to track, compare outcomes, report safety and efficacy.

The registry is a multi-institutional bioinformatics database for the collection of data relevant to Inferior vena cava filters. Participating study centers may enroll patients and enter data in the web-based registry that include demographics, clinical features, management details and follow-up up to 48 months.

The purpose of this study is to improve our understanding of the retrieval rate, long term safety and efficacy on IVC filters placed in North America.

Eligibility Criteria:
Inclusion Criteria:

* Data obtained in line with good clinical practice,applicable laws and regulation
A Randomised Open Controlled Parallel Group Study Comparing Norspan and Tramadol

To evaluate the efficacy and safety of Norspan versus Tiperol Retard among OA patients who are sub-optimally treated with current analgesic. Those patients may benefit from treatment with a long lasting analgesic.


Eligibility Criteria:
Inclusion Criteria:

* OA diagnosis
* BS11 greater than or equal to 4 at base line
* Not adequately pain relieved with 4,000 mg paracetamol daily

Exclusion Criteria:

* Treated with high potent opioids for their OA pain
* Treated with a regular dose for greater than one week of Tramadol, Codeine or dextropropoxifene during the last three months
* Other chronic conditions requiring frequent analgesic therapy
Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

The DART-HA study is a single-center, open label, trial intended to evaluate the clinical efficacy of standard treatment options for congestive heart failure (observation, diuretic or afterload reduction therapy) in patients without new symptoms who have developed abnormalities of the HeartLogic heart failure diagnostic feature.

Subjects with congestive heart failure (CHF) who have undergone implantation of a Boston Scientific pacemaker/defibrillator with a HeartLogic sensor will be remotely monitored for for elevation of their HeartLogic score which is indicative of worsening heart failure. Subjects whose devices demonstrate HeartLogic score elevations and also do not demonstrate symptoms from heart failure will be randomized to observation or one of two standard treatments for worsening heart failure, afterload reduction or diuretic therapy. Subjects will be followed to assess the change in HeartLogic score, incidence of the the HeartLogic score returning to normal levels, the development of symptoms of heart failure and/or the need for treatment for heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Boston Scientific device with HeartLogic enabled
* Lack of standard contraindications to Sacubitril/valsartan:

  * history of ACE-inhibitor induced angioedema and in those with angiotensin II receptor blocker (ARB) therapy induced angioedema.
  * hypotension, hypovolemia
  * renal artery stenosis, renal failure
  * hyperkalemia
  * hepatic disease Child-Pugh class C
  * Pregnancy/Breast-feeding
* Lack of standard contraindications to diuretic therapy
* Systolic Blood Pressure \> 105

Exclusion Criteria:

* Glomerular filtration rate \<25 mL/min who are non-responsive to diuretic therapy or are on chronic renal dialysis
* ongoing symptoms of heart failure decompensation (increased dyspnea and/or fatigue, for purposes of this study increased weight is not considered, see question 2 KCCQ).
* recent significant change in arrhythmia burden (within the past 2 weeks)
* in cardiac resynchronization therapy (CRT) patients, recent change (60 days) in effective delivery of CRT (eg. decreased biventricular paving %)
* the subject is unable to sign or refuses to sign the patient informed consent
* Symptomatic heart failure at rest or New York Heart Association Class IV at the time of enrollment
* the subject is implanted with unipolar right atrial or right ventricular leads
* subject has received or is scheduled to receive a heart transplant or ventricular assist device within the next 6 months
* subject is pregnant or planning to become pregnant during the study
* regularly scheduled IV heart failure therapy (e.g. inotropes or diuretics)
Robotic-Assisted or Laparoscopic Radical Resection for Rectal Cancer With or Without Left Colic Artery Preservation

Brief Summary

Background The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.

Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function.

The investigators retrospectively collected data from the medical records of participants who had rectal cancer at Northern Jiangsu People's Hospital, from April 2020 to May 2023. A total of 612 from 1164 cases were included in this study; in 462 cases, the LCA was preserved by LL intraoperatively (LL group), in which 202 cases underwent robotic-assisted laparoscopy (LL-RAL subgroup) and 260 cases underwent laparoscopy (LL-LSC subgroup). While in the remaining 150 cases, the LCA was not preserved by HL intraoperatively (HL group). in which 70 cases underwent robotic-assisted laparoscopy (HL-RAL subgroup) and 80 cases underwent laparoscopy (HL-LSC subgroup).

Eligibility Criteria:
Inclusion Criteria:

* Low anterior resection for rectal cancer
* Postoperative pathological diagnosis of rectal adenocarcinoma
* Informed consent signed prior to surgery.

Exclusion Criteria:

* Recurrent rectal cancer
* Emergency surgery
* Preoperative and intraoperative detection of distant organ metastases or extensive
* Implantation metastases in the abdominal cavity
* Palliative surgery
* A postoperative pathology report that showed residual cancer cells at the proximal or distal resection margin
* No standard chemotherapy for tumor-node-metastasis (TNM) staging II or III after surgery
* Synchronous colorectal carcinoma and other organ tumors
* Incomplete case data.
Gender Heterogeneity in the Influencing Factors for Cerebral Microbleeds in Acute Ischemic Stroke Patients

The investigators continuously collected data from 482 AIS inpatients at the Neurology Department of Hebei General Hospital. Both demographic and clinical data were collected from the study subjects. Different head magnetic resonance imaging sequences were used to assess the subjects' CMBs, white matter lesions, and old lacunar infarcts (LI). Various statistical methods, including the t-test, χ2 test, and logistic regression, were used to analyze the gender heterogeneity of the influencing factors for CMBs in AIS patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years and older
* Must meet the diagnostic criteria for AIS as presented in the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2014
* Must be in good physical condition and have the ability to cooperate with MRI examinations
* Must have underwent SWI

Exclusion Criteria:

* MRI contraindications present, such as cardiac pacemaker, cardiac stents, or metal implants
* Head MRI or carotid artery ultrasound suggests the presence of severe stenosis or occlusion in the intracranial or extracranial segments of the cerebral arteries
* Severe comorbid diseases, such as cardiac, pulmonary, hepatic, and renal insufficiencies
My Life, My Healthcare

This study is designed to answer the following questions: "Is the My Life, My Healthcare Discussion Aid feasible for use in primary care? Does it positively impact patient and healthcare teams' care experience and communication, while reducing patient treatment burden?"

Through implementation of the My Life, My Healthcare Discussion Aid for patients with chronic conditions, the study team hypothesizes that it will be feasible to implement in routine primary care practice and positively impact patient and healthcare teams experience of chronic care, while reducing patient treatment burden.


Eligibility Criteria:
InclusionCriteria: Particpant population will include patients 18 years of age or older who have one or more chronic conditions and do not have any barriers to consent (such as major cognitive disabilities) will be eligible for enrollment. Clinicians who treat patients with chronic conditions at participating sites are eligible for enrollment.

Exclusion Criteria: Patients who do not have a chronic condition, or have barriers to consent such as cognitive impairment will be excluded from the study. Health professionals who do not treat patients with chronic conditions will not be included.
Post COVID19 Functional and Cognitive Assessments

The main objective of the proposed study is to evaluate the impact of coronavirus (2019-nCoV), hereafter COVID -19, on patients' loss of functional capacity after completion of hospital treatment. Specifically, the research will focus on examining changes in musculoskeletal, cardiovascular, and respiratory function, as well as motor control. In addition, we aim to evaluate rehabilitation treatments after recovery from COVID -19 and consider additional preventive measures based on previous experience.

The combination of such a severe respiratory disease as COVID -19 with motor inactivity could have very serious consequences for a person's general health even after COVID -19 symptoms have subsided. To date, the effects of COVID -19 on individual muscle status have not been extensively studied. Therefore, the main objective of this study will be to evaluate the muscle status of patients after COVID -19. In addition, we will be interested in longitudinal monitoring of individuals' rehabilitation, where they will receive instructions based on measured outcomes at hospital discharge. We will also be interested in considering additional preventive measures for future patients based on previous experience of infected and hospitalized COVID -19 patients.

Eligibility Criteria:
Inclusion Criteria:

* Completed hospital treatment after a positive COVID-19 test
* Signed written consent

Exclusion Criteria:

* Still testing positive for COVID -19 at discharge.
* Severe musculoskeletal injuries (e.g., disability).
* Inability to follow instructions when performing the test.