cyrilzakka/clinical-trials huggingface dataset:
BE Study of Torrent's Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide Tab - Fed Conditions

Subjects to compare the single dose bioavailability of Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets 40+10+25 mg and Tribenzor® 40+10+25 mg Tablets of Daichi Sankyo Inc, USA. Dosing periods of studies were separated by a washout period of 22 days.

An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose Bioequivalence Study of Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg ( Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Tribenzor® 40+10+25 mg Tablets containing Olmesartan medoxomil 40 mg, Amlodipine 10 mg and Hydrochlorothiazide 25 mg (Reference , Daichi Sankyo Inc., USA) in Healthy Human Volunteers Under Fed Condition.

Eligibility Criteria:
Inclusion Criteria:

* Sex: male
* Age: 18-45 years (inclusive both)
* Volunteer with BMI of 18-25 (inclusive both) kg/m2
* Healthy and willing to participate in the study.
* Volunteer willing to adhere to the protocol requirements and to provide written informed consent.
* Preferably Non-smokers

Exclusion Criteria:

The volunteers were excluded from the study based on the following criteria:

* Clinically relevant abnormalities in the results of the laboratory screening evaluation.
* Clinically significant abnormal ECG or Chest X-ray.
* Systolic blood pressure less than 110 mm Hg or more than 140 mm Hg and diastolic blood pressure less than 70 mm Hg or more than 90 mm Hg.
* Pulse rate less than 60/minute or more than 100/minute. Oral temperature less than 95°F or more than 99°F.
* Respiratory rate less than 14/minute or more than 18/minute
* History of allergy to the test drug or any drug chemically similar to the drug under investigation.
* History of alcohol or drug abuse
* Positive breath alcohol test
* Recent history of kidney or liver dysfunction.
* History of consumption of prescribed medication since last 14 days or OTC medication since last 07 days before beginning of the study.
* Volunteers suffering from any chronic illness such as arthritis, asthma etc.
* History of heart failure.
* HIV, HCV, HBsAg positive volunteers.
* Opiate, tetra hydrocannabinol, amphetamine, barbiturates, benzodiazepines, Cocaine positive volunteers based on urine test.
* Volunteers suffering from any psychiatric (acute or chronic) illness requiring medications.
* Administration of any study drug in the period 0 to 3 months before entry to the study.
* History of significant blood loss due to any reason, including blood donation in the past 3 months.
* History of pre-existing bleeding disorder.
* Existence of any surgical or medical condition, which, in the judgment of the chief investigator and/or clinical investigator/physician, might interfere with the absorption, distribution, metabolism or excretion of the drug or likely to compromise the safety of volunteers.
* Inability to communicate or co-operate.
Exercise and Oscillatory Positive Expiratory Pressure Therapy in Cystic Fibrosis

The investigators aim to compare a single bout of moderately intense cycling exercise incorporating Flutter® breathing maneuvers with a single bout of moderately intense cycling exercise alone on sputum viscoelasticity (primary endpoint) and the diffusion capacity of the lungs in adult patients with cystic fibrosis.

The investigators further aim to analyze the short-term variability of resting diffusion capacity of carbon monoxide (DLCO) and nitric oxide (DLNO) in patients with cystic fibrosis.

Regular airway clearance is an integral component of cystic fibrosis care and of critical importance to lung health. Exercise and standardized chest physiotherapy are accepted airway clearance techniques in cystic fibrosis. Different airway clearance techniques are available, but there is no evidence that one technique or a combination is superior. Oscillatory positive expiratory pressure with the Flutter® is a widely used airway clearance technique in the European countries and has been shown to favourably alter sputum viscoelasticity in cystic fibrosis.

This randomized crossover study is designed to assess the acute effects of combined cycling exercise and Flutter® therapy on sputum viscoelasticity (primary outcome measure) and gas diffusion in adults with cystic fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of CF based on either two CF-causing mutations and/or a sweat chloride concentration during two tests of \> 60 mmol/l
* Patients that are able to provide sputum samples
* Adult age ≥ 18 years

Exclusion Criteria:

* Unstable condition affecting participation in the exercise experiments (i.e., major hemoptysis or pneumothorax within the last 3 months, acute exacerbation and iv-antibiotics during the last 4 weeks, unstable allergic bronchopulmonary aspergillosis, listed for lung transplantation, major musculoskeletal injuries such as fractures or sprains during the last 2 months, others according to the impression of the doctor)
* Cardiac arrhythmias with exercise
* Requiring additional oxygen with exercise
* Colonization with Burkholderia cenocepacia
* Status post lung transplantation
suPAR in the Early Diagnosis of Acute Kidney Injury(AKI) After On-Pump Cardiac Surgery

Acute Kidney Injury(AKI) is of the serious complications in patients with undergoing on-pump cardiac surgery. End stage kidney failure requiring dialysis therapy after cardiac surgery is associated with more than 60% mortality rate. Involvement of AKI after on-pump cardiac surgery increases the mortality rate 19 times. suPAR is one of the novel biomarker which has potential prognostic value for renal dysfunction in patients with undergoing on-pump cardiac surgery. Early diagnosis and prompt intervention to prevent AKI has great importance for management of postoperative cardiac patients.


Eligibility Criteria:
Inclusion Criteria:

* Approved informed concent Age higher than 18 years old

Exclusion Criteria:

* Chronic kidney disease Renal transplantation Cancer history Previous cardiac surgery Sepsis Liver failure Thyroid dysfunction Having long term steroid therapy Having renal replacement therapy Exposure to nephrotoxic drug and radiocontrast substance before 5 days of surgery Diagnosis of Acute Kidney Injury Intraaortic balloon or Extracorporeal Membrane Oxygenation insertion after surgery
Development of Delirium in Patients Undergoing Open-Heart Surgery

Malnutrition is a prevalent issue among patients undergoing cardiac surgery. This can lead to delirium risk factors, including postoperative functional and cognitive impairment. Assessing the patient's nutritional status before open-heart surgery may decrease the incidence of delirium and the psychological and physiological problems associated with it. The objective of this study was to examine the relationship between nutritional status and the incidence of postoperative delirium in patients who have undergone open-heart surgery.

Upon examining the literature, it was found that the incidence of delirium after open heart surgery ranged from 3% to 70% (Tomakin et al., 2020). Postoperative delirium has numerous risk factors, including predisposing and accelerating factors. Predisposing risk factors comprise malnutrition and electrolyte imbalance, cognitive impairment, depression, and other psychiatric disorders such as dementia (Velayati et al., 2019; Wilson et al., 2020). This study aims to investigate the relationship between the nutritional status of patients undergoing open heart surgery and the development of postoperative delirium. The study will be conducted in the Cardiovascular Surgery Intensive Care Unit of Bursa Uludag University Health Application and Research Centre Hospital between September 2023 and February 2024. Data will be collected using the Personal Information Form, Nutritional Risk Screening Score 2002 (NRS-2002), Delirium Risk Assessment Form, Visual Analogue Scale for Pain Levels, Richmond Agitation Sedation Scale, Glasgow Coma Scale, and Confusion Assessment Scale in Intensive Care Unit.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Having undergone open heart surgery
* No mental deficiency and visual and hearing impairment
* No psychiatric diagnosis and no medication for this purpose
* Participants' acceptance to participate in the research
* The patient is not in coma (RASS score between -3 and +4, GCS score of 10 and above)

Exclusion Criteria:

* Open heart surgery under emergency conditions
* Diagnosed with delirium, dementia, psychiatric illness before surgery
* Alcohol and drug addiction
* Dying in the intensive care unit within 24 hours
Capacity Assessment in Persons With Alzheimer's Disease

The purpose of this study is to assess decision-making capacity in persons with Alzheimer's disease. First, our goal is to validate four French capacity assessment tools for persons with Alzheimer's Disease : a French version of the Competency Assessment Tool for Consent to Treatment and of the Competency Assessment Tool for Voting, two questionnaires assessing the capacity to appoint a proxy either to consent to treatment or to vote. Second, once validated, we plan these questionnaires to study decision-making abilities and their determinants in persons with Alzheimer's disease and control subjects.

Study of Alzheimer's disease patients show a wide variability in decision-making abilities, especially for the consent to treatment and the ability to vote. No tools are available to assess the capacity to design a proxy. The purpose of this research is to assess simultaneously four decision-making abilities in persons with Alzheimer's disease: the capacity to consent to treatment, the capacity to vote and the capacity to design a proxy either to consent to treatment or to vote.

This study will recruit 320 patients with Alzheimer's disease and 80 non-demented control subjects. Four decision-making questionnaires will be administered to participants to explore participant capacity to understand, reason, appreciate and make a choice about the capacity to consent to treatment, to vote and to design a proxy either to consent to treatment or to vote. Once validated in the first part of this research, the questionnaires will be used to study decision-making abilities and their determinants in patients with Alzheimer's disease and control subjects.

Eligibility Criteria:
Inclusion Criteria:

* for patients with Alzheimer's disease: age \>=18 years, to be native speakers of French and French nationality, Diagnosed with a Alzheimer's disease and followed in a French "Centre Memory of Resources and Research"(CMRR)
* for control subjects: age \>=18 years, to be native speakers of French and French nationality, have no complaints of memory problems, primary caregiver of patient with AD of the same age as the patient nearly 10 years

Exclusion Criteria:

* for all participants: confusion, severe psychiatric disorders, stroke, blindness, uncorrected hearing loss, refusal to participate in the study
* for patients with Alzheimer's disease: other dementia than AD
* for control subjects: diagnosed dementia
Move For Surgery - A Novel Preconditioning Program

Lung cancer is the leading cause of cancer death in Canada. Most patients with this cancer will undergo treatment with major chest surgery that is associated with serious complications. As many as 50% of patients will suffer respiratory complications after surgery, keeping them in the hospital for extended periods of time. These long hospitalizations have a dramatic negative effect on the lives of those people, in addition to a large cost burden on our healthcare system. Traditionally, patients who suffer from complications are treated with rehabilitation AFTER the complications have occurred. But what if complications can be prevented BEFORE they happen? Having major chest surgery imposes great stress on the human body, one that is equivalent to running a marathon. Analogous to training before completing a marathon, the investigator designed Move For Surgery (MFS), a novel preconditioning program that encourages and empowers patients to improve their health prior to surgery. The investigator aims to demonstrate that patients who train with Move For Surgery will have lower respiratory complication rates, will recover better, and will leave the hospital sooner than their counterparts.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Clinical stage I, II, or IIIa non-small cell lung cancer (NSCLC)
* Candidates for thoracic surgery, as determined by the operating surgeon

Exclusion Criteria:

* Clinical stage IIIb or IV NSCLC
* Patients with affected mobility (wheelchair, walker)
* Patients who use oxygen at home
Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)

The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.

This study is an extension study (V110-007-10) which met requirements for posting on clinicaltrials.gov. The original study (V110-007-00) was completed in 2004 and did not meet the criteria for registration.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal or negative urine pregnancy test if female
* No fever on the day of vaccination

Exclusion Criteria:

* History of allergy to vaccine components
* History of pneumococcal disease
* Received any live virus vaccination within 4 weeks prior to study start
* Received any inactivated vaccination within 7 days prior to study start
* Received any blood products within 5 months prior to study start
* Participated in an investigational drug or vaccine study in the past 30 days
* Received immunosuppressive therapy
* Patient has an immune deficiency
The Effects of Risperidone and Olanzapine on Thinking

The goal of this research is to find ways to maximize the benefits of antipsychotic medications for cognition.

Hypothesis: Risperidone and olanzapine will show greater benefits than conventional medications on assessments of social cognition, particularly affect perception and social perception.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with schizophrenia disorder by a DSM IV.
* Competent to sign informed consent
* No history of poor response to Risperdal and Zyprexa
* No organic brain disease

Exclusion Criteria:

* Mental retardation or any chronic medical illness which results in the patient not being appropriate for a switch to Risperdal or Zyprexa.
Study to Evaluate the Safety and Pharmacokinetics of SPI-1005

A study to determine the safety, tolerability, and pharmacokinetics of SPI-1005 capsules in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male and female subjects
* Within 15% of their ideal weights (Table of "Desirable Weights of Adults," Metropolitan Life Insurance Company, 1983)
* Medically healthy subjects with clinically insignificant screening results (laboratory profiles, medical histories, ECGs, physical exam);
* Voluntarily consented to participate in the study;
* Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to screening and throughout the study or used one of the following acceptable birth control methods: Intrauterine device (IUD) in place for at least 3 months prior to study; Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; Stable hormonal contraceptive for at least 3 months prior to study through completion of study; Surgical sterilization (vasectomy) of partner at least 6 months prior to study. Females of non-childbearing potential were surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study, hysterectomy, or bilateral oophorectomy at least 2 months prior to study).

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, otologic, or psychiatric disease;
* History or presence of alcoholism or drug abuse within the past 2 years;
* Hypersensitivity or idiosyncratic reaction to compounds related to ebselen;
* Use of any prescription medication within 14 days (with the exception of hormonal contraceptives) prior to or during the study;
* Use of any over-the-counter medication including vitamins, herbal preparations, antacids, cough and cold remedies, etc., within 7 days prior or during the study;
* Use of any drugs or substances known to be strong inhibitors or inducers of cytochrome P450 enzymes within 28 days prior to dosing;
* Abnormal diet (for any reason) during the 30 days prior to dosing;
* Donation of whole blood within 56 days prior to the study;
* Plasma donation within 7 days prior to the study;
* Participation in another clinical trial within 30 days prior to the study;
* Female subjects who were pregnant or lactating;
* Hemoglobin \< 12.0 g/dL;
* Orthostatic vital signs which result in: A pulse increase of more than 30 beats per minute after 3 minutes standing (compared with semi-recumbent pulse rate); or A pulse rate greater than 100 bpm after 3 minutes standing; or A drop in systolic blood pressure decrease of at least 20 mm Hg; or A diastolic blood pressure decrease of at least 10 mm Hg within 3 minutes of standing (compared with semi-recumbent blood pressure).
Efficacy of Compound Betamethasone Injection Combined With Ropivacaine in Ultrasound-guided Intercostal Nerve Block for Chronic Post-thoracotomy Pain

The patients were divided into two groups by random number method: GroupRD1 group and GroupRD2 group were given general anesthesia and intercostal nerve block.The drug for intercostal nerve block was 0.33% ropivacaine +2.333mg compound betamethasone (1.667mg betamethasone dipropionate + 0.667mg betamethasone sodium phosphate) to 15ml.

The RD1 group received ultrasound-guided intercostal nerve block at the incision before anesthesia induction, and the RD2 group received ultrasound-guided intercostal nerve block at the lateral costal Angle before anesthesia induction.

Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old
2. ASA grade I-III
3. BMI: 18.5-28kg/m2
4. Type of surgery: elective thoracoscopic lung mass resection
5. Informed consent has been signed by the patient and/or family members

Exclusion Criteria:

1. game anesthesia or sugar cortical hormone drugs allergic
2. preoperative use of opioid medicines
3. serious blood coagulation dysfunction
4. serious heart, lung, liver and renal insufficiency
5. put, chemotherapy, and glucocorticoid immunosuppressive therapy history or diseases of the immune system
6. peptic ulcer
7. newly gastrointestinal surgery
8. has a history of thoracic surgery
9. is the central nervous system disease
10. Other glucocorticoids should be used with caution in patients such as fractures, wound repair, corneal ulcers, hyperadrenocortical disease, diabetes mellitus, pregnant women, etc.
Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.

Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality. Globally, it is responsible for 25% of all pregnancy-related deaths. PPH is unpredictable and may occur in the absence of risk factors. Tranexamic acid is an antifibrinolytic proven to reduce blood loss and transfusion requirements for various surgeries. This study aims to explore the effectiveness of tranexamic acid as an adjunct to other uterotonics before the Caesarian Section.


Eligibility Criteria:
Inclusion Criteria:

1. The women undergoing cesarean delivery (both elective and emergency) during the study period.
2. Willing to participate in the study after understanding the concept.

Exclusion Criteria:

1. Critically ill patient.
2. Not willing to give consent to participate in the study
3. Cases diagnosed with a ruptured uterus or undergoing caesarian hysterectomy during operation.
Effect of Remote Intervention in Patients With SCAD

The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated a remote intervention with 1 year of follow-up.

Objective: This study is intended to verify the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease.

Study design: The study was a multicenter, two-arm, parallel, open-label, prospective clinical trial that evaluated the effect of a remote intervention on adherence to drugs and risk factors control in patients with stable coronary artery disease with 1 year of follow-up.

Study intervention: Participants in the experimental group received remote guidance from the cardiac rehabilitation team in the community hospital every month after enrollment. The control group had no special intervention. All patients received follow-up at 6 months and 1-year follow-up.

Outcome measures: The primary outcome was medication adherence. Secondary outcomes included smoking, drinking, blood pressure, body mass index, LDL cholesterol, HbA1c, and major adverse cerebral cardiovascular events(MACCE). Medication compliance consists of the following five medications: aspirin, P2Y12 receptor antagonist, statin, ACEI/ARB and beta-blocker.

Statistical analysis: Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 18-99 years
2. Diagnosed with SCAD according to guidelines by coronary CTA or coronary angiography (including stable angina, ischemic cardiomyopathy, and the stable course after acute coronary syndrome)
3. Have sufficient Chinese language proficiency to reading, speaking and listening
4. Live with at least one caregiver or guardian in the household
5. Presence of stable hemodynamics without using vasopressor
6. Able to individually consent
7. Not participating in any other clinical trial

Exclusion Criteria:

1. Unable to provide informed consent
2. Unable to be involved in clinical follow-up and treatment
3. Suffered comorbidity with a life expectancy of less than 1 year
4. Have contra-indication to cardiac rehabilitation
5. Acute coronary syndrome
6. History of noncompliance with medical therapy
7. Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial
8. Planned major surgery necessitating interruption of antiplatelet therapy
9. Inability to comply with the protocol
10. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject or that could prevent, limit or confound the protocol-specified assessments