cyrilzakka/clinical-trials huggingface dataset:
The Effects of Exercise Intervention on Skeletal Muscle and Other Organs in Aged Population and the Discovery of Associated Circulating Biomarkers

This project aims to investigate the intricate interplay between skeletal muscle and adipose tissue during the aging process by integrating human studies. Utilizing interventional research and randomized trials combined with examining blood samples from elderly individuals engaged in exercise, we aim to investigate the effects of exercise on muscle health and explore the underlying mechanisms of muscle aging and related biomarkers. Interdisciplinary research allowed us to investigate the systemic impact of exercise on muscles. This approach allowed us to gain a better understanding of the interconnectedness of skeletal muscle and adipose tissue in the aging process and devise efficient strategies to reverse age-related changes. These findings hold promise for promoting a future society where long and healthy life is achievable for all.

This study is a randomized controlled trial of 6-month multidomain intervention program among community-living older adults with early physical impairments.

Inclusion criteria are: (1) community-dwelling adults aged ≥ 65 years, (2) slow gait speed (\<1 m/s in 6-meter walk test) or weakness (dominant handgrip strength \<28 kg in men, \<18 kg in women); subjects with the following conditions will be excluded: (1) established diagnosis of dementia, Parkinsonism or other neurodegenerative disease (2) disable status: mobilitylimiting conditions, (3) active, acute diseases receiving treatment, such as cancer, heart failure, COPD and so on, (4) estimated life expectancy \<12 months, (5) current nursing home residents.

Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 65 years
* slow gait speed (\<1 m/s in 6-meter walk test) or weakness (dominant handgrip strength \<28 kg in men, \<18 kg in women)

Exclusion Criteria:

* established diagnosis of dementia, Parkinsonism or other mobility-limiting, disable conditions
* active, acute diseases receiving treatment, such as cancer, heart failure, COPD and so on
* estimated life expectancy \<12 months
* current nursing home residents
Bioequivalency Study of Ramipril 10 mg Capsules Under Fed Conditions

The objective of this study was to prove the bioequivalence of Ramipril 10 mg capsules under fed conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Ramipril or any comparable or similar product.
A Study to Evaluate Effectiveness and Safety of ER OROS Paliperidone in Patients With Schizophrenia

The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have given their own consent in writing to participate in the study
* Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 295.30, 295.10, 295.20, 295.90, 295.60)
* Patients who have acute symptoms of schizophrenia
* Both inpatients and outpatients are acceptable

Exclusion Criteria:

* A DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) of a mental disease diagnosis other than schizophrenia
* A DSM-IV diagnosis of substance-related disorder (except nicotine dependence and caffeine dependence) within 180 days before the screening test
* Total PANSS (Positive and Negative Syndrome System) score at the screening test \<70 or \>120
* Patients treated with three or more types of antipsychotic within 28 days before the screening test
* Parkinson's disease (except for those with drug-induced extra pyramidal symptoms)
* Patients with a complication of or a past history of cerebrovascular accident
* Patients with a complication of or a past history of diabetes mellitus
Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Stereoscopic Microscopy Study

The aims of this study are: 1) To identify more resistant the guidewire type to the retrieval maneuvers after the jailing.

2) To determined anatomic and technical factors influencing the induced damage in the guidewire.

Design of the study: prospective randomized study to compare 2 types of guidewire: hydrophilic and no hydrophilic. Patients and methods: Two hundred patients with bifurcation coronary lesions will be included. All of then will be treated by provisional side-branch stenting using the jailed wire technique. One hundred patients will be randomized to hydrophilic wires and another 100 patients to non-hydrophilic wires.

The percutaneous approach of bifurcation lesions is a complex procedure; when the stent is implanted at main vessel, a closure of the side-branch may occur. The re-wiring of the side-branch in these conditions may be difficult or even impossible. To facilitate the re-wiring maneuvers the operators use the jailed wired technique. For this technique a guide-wire is introduced in the side-branch before main vessel stent implantation; after the stent deployment the wire remains jailed between the vessel wall and the metallic structure of the stent. If the side-branch became occluded, this wire is a good landmark of it is position, facilitating the access with a new wire. However, the rupture of the wire has been described in some cases, during the retrieval maneuvers.

Eligibility Criteria:
Inclusion Criteria:

* Patients with atherosclerotic coronary disease and bifurcation lesions requiring protection with side branch.
* The art of imprisoned guide.
* The main branch should be greater than 2.5 mm in diameter at the operator's visual estimate.
* The side branch must exceed 2 mm in diameter or have sufficient authority to protect the operator decides with a guide for the release of the main vessel stent.
* Patients with the above characteristics and main or side branch of any length.
* Patients with bifurcation lesions with any morphology of the Medina classification: 1 1 1 1 0 1 0 1 1, 110, 001, 010, 100.
* Treatment of bifurcation with any technique and any type of stent in the side branch meets the criteria above.
* Symptoms of stable angina or acute coronary syndrome.

Exclusion Criteria:

* Patients with collateral bouquet of little significance.
* Patients in cardiogenic shock.
* Patients in whom it is impossible to guide the placement of the side branch before implantation in the glass principal.
* Patients who do not give their consent for the study.
Demographic and Clinical Predictors of Persistence in Patients Treated With Aripiprazole Once-monthly in Italy

This is an observational, retrospective, non-interventional study that will include schizophrenic patients who were initiated with aripiprazole once-monthly as per normal clinical practice at least 6 months before the data collection starts (inclusion visit), and is designed to evaluate demographic and clinical predictors of persistence with this treatment.

Data from each patient will be collected after informed consent is signed (inclusion visit), and will include retrospective information from the start of aripiprazole once-monthly treatment initiation (index date) until the follow-up/inclusion visit (minimum of 6 months after the index date). Data will be retrospectively collected from all visits occurring as per clinical practice (usually once monthly).


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (age ≥ 18 years at the time of aripiprazole once-monthly initiation)
2. Male or female
3. Diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5), available at start of aripiprazole once-monthly treatment, and confirmed by the current investigator
4. Aripiprazole once-monthly initiation (at least 1 injection) according to the clinical practice, at least 6 months before the inclusion and on June 1st 2015 or at a later date (index date)
5. Aripiprazole once-monthly was the main antipsychotic at the time of treatment initiation
6. Willingness to participate in the study; subjects must give their written consent to participate

Exclusion Criteria:

1. The patient has a psychiatric disorder other than schizophrenia as primary diagnosis
2. Participation in a clinical trial during the retrospective follow-up period.
COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System.

Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient age ≥ 18
* Pre-stroke mRS 0-1
* Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System
* Planned frontline treatment with Penumbra System
* Signed informed consent per Institution Review Board/Ethics Committee

Exclusion Criteria:

* Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days.
* Currently participating in an investigational (drug, device, etc) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.
Clinical Evaluation of Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening

the study compare gingival margin stability following conventional approach versus microsurgical approach of esthetic crown lengthening in management of patients with short clinical crowns in the upper anterior region.In management of patients with short clinical crowns in the upper anterior region, there is no difference in gingival margin stability between conventional and microsurgical approaches of esthetic crown lengthening.


Eligibility Criteria:
Inclusion Criteria:

* Patients with healthy systemic condition.
* Adult patients ˃ 18 years old.
* The presence of the six upper anterior teeth.
* Absence of sites with attachment loss and probing depth (PD) \>3 mm
* Keratinized gingiva of at least 2mm width.
* Compliance with good oral hygiene.
* Patients accepts 6-months follow-up period (cooperative patients).
* Patients provides an informed consent

Exclusion Criteria:

* Gummy smile with normal tooth proportions
* Presence of prosthetic crowns
* Extensive restorations
* Extensive incisal edge attrition.
* Misalignment on maxillary anterior teeth.
* Smokers ˃ 10 cigarettes / day.
A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients

A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probably Alzheimer's disease for at least 1 year.
* Mini Mental State Exam (MMSE) score between 12-26 at screening.
* Participants must be receiving a cholinesterase inhibitor and/or memantine for at least 4 months, and on a stable dose for at least 2 months.

Exclusion Criteria:

* Current evidence of a neurological or psychiatric illness that could contribute to dementia.
* Living alone.
* Poorly controlled high blood pressure.
Integration of Education Based-Application and "CARE Coaching Model" in Management of Type 2 Diabetes Mellitus Patients Using Insulin

Diabetes mellitus is increasing in incidence worldwide. The goal of management of diabetes is to achieve blood sugar control by minimizing side effects and preventing short and long term complications. Self-management becomes important in the management of diabetes mellitus. The use of mobile phone applications provides opportunities for the management of diabetics. In addition, health coaching is one of method used for empowering patients with chronic diseases, such as diabetes. This study aims to evaluate the impact of Mobile Application-Based Diabetes Education and health coaching in management of type 2 diabetes mellitus.

A randomized control trial, pre and post study involving 105 subjects randomized into 3 arms:

* Control : received conventional education group
* Intervention 1 : received conventional education group + mobile application-based diabetes education
* Intervention 2 : received mobile application-based diabetes education + health coaching

Conventional education group divided into 6 session, which for each session consist of 2 different topics and lasts for 60 minutes.

Mobile application-based diabetes education is using DM Educorner (Diabetes Mellitus Education Corner) availablle in Google PlayStore. Education contents was delivered in articles, video and infographics.

Health coaching was given by a coach, a healthcare professional who undergo training to become a coach. Health coaching delivered as face to face between subjects and coach.

Laboratory examination and questionnaire collected at baseline, 3 and 6 months after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* multiple daily insulin injection (basal and rapid, or mixed)
* 30 - 65 years old
* HbA1c \> 8%
* Using smartphone in daily lives.
* Willing to follow the research by signing an informed consent

Exclusion Criteria:

* Patients with cognitive disease (such as dementia)
* Patients with hearing or sight problem
* Unable to live independently on daily basis
* Patients who have disease that may affect Hba1c such as hemolytic anemia, thalassemia
A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo

The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used.

IDA is highly prevalent in subjects and can have a substantial medical and quality of life (QoL) burden on the subjects and the treatment of these subjects includes replenishing lost iron. Oral iron administration is often used in the clinical practice at many clinics; however, oral iron may not be tolerated by all subjects. Hence, there is a need for an alternative iron treatment in subjects, who do not tolerate oral iron.

This study is planned to compare the efficacy and safety of iron isomaltoside 1000 with placebo in subjects with IDA and who are intolerant or unresponsive to oral iron therapy..

Eligibility Criteria:
Inclusion Criteria:

1. Men or women ≥ 18 years having IDA caused by different aetiologies\* such as ab-normal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy\*\* for at least one month\*\*\* prior to study enrolment
2. Hb \< 11 g/dL
3. TSAT \< 20 %
4. S-ferritin \< 100 ng/mL
5. Willingness to participate and signing the informed consent form (ICF)

Exclusion Criteria:

1. Hb \< 6 g/dL
2. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreat-ed vitamin B12 or folate deficiency, haemolytic anaemia)
3. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and hae-mosiderosis)
4. Decompensated liver cirrhosis or active hepatitis (ALAT \> 3 times upper limit of normal)
5. Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
6. Body weight \< 50 kg
7. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing
8. History of multiple allergies
9. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
10. Erythropoietin treatment within 8 weeks prior to the screening visit
11. Other intravenous (IV) iron treatment or blood transfusion within 4 weeks prior to the screening visit
12. Participation in any other interventional clinical study within 3 months prior to the screening
13. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus
Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus

This is a randomized, active-controlled, open-label study to assess the safety, tolerability and efficacy of Afabicin in the treatment of participants with bone or joint infection due to Staphylococcus aureus \[both methicillin-susceptible S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)\] and/or coagulase-negative staphylococci (CoNS) and to compare it to standard of care (SOC).


Eligibility Criteria:
Key Inclusion Criteria:

* Able to provide written informed consent and to comply with study procedures.
* Diagnosis of bone or joint infection which fulfils the following conditions: a) Infection is due to S. aureus (MSSA or MRSA) and/or CoNS only; and, b) Participants had received no more than 7 days of empiric antibiotics prior to initiating treatment with study drug unless the pathogen isolated was resistant to the administered empiric antibiotics; and, c) Biofilm is not considered to be yet established and/or has been mechanically eradicated; and, d) Infection is not associated with an ischiatic or a sacral osteomyelitis; and e) Infection can involve periosteal or soft tissue.

Key Exclusion Criteria:

* Presence of co-infection with non-staphylococcal bacteria at the affected joint or bone site, or in the blood.
* Participants at an increased risk of developing liver injury.
* Participants who have medical conditions that increase the risk of QT prolongation.
* Medical history within the previous 3 months of: myocardial infarction, unstable angina pectoris, coronary artery or cerebral revascularization procedure or stroke, ventricular tachycardia, multifocal ventricular ectopics requiring treatment, or any other clinically relevant symptomatic ventricular arrhythmias.
* Documented history of alcohol or drug abuse within the previous 12 months.
* For patients with DFO:

  1. Severe peripheral arterial disease (PAD) requiring revascularization; however, patients with peripheral artery disease are eligible for inclusion, provided they have undergone successful revascularization or it has been deemed unnecessary by a vascular surgeon
  2. Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue).
  3. Patients with Charcot foot (suspected neuro-osteoarthropathy according to Investigator's judgment).
  4. Need for digital amputation.
* Life expectancy of less than 1 year.
Measurement of the Second Gas Effect on Sevoflurane in Anaesthetised Patients

This study is investigating the "second gas effect", a phenomenon produced by the uptake of nitrous oxide (N2O) by the lungs, during the course of a typical anaesthetic. The effect is to increase the concentration of other breathed gases in the lung. These include oxygen and volatile anaesthetic agents such as sevoflurane, which are also normally administered along with N2O. We wish to i) measure the magnitude of the second gas effects on both blood and expired concentrations of sevoflurane (Part 1), and ii) see if a demonstrable difference exists between the effects on blood and expired concentrations.

This study is investigating the "second gas effect", a phenomenon produced by the uptake of nitrous oxide (N2O) by the lungs, during the course of a typical anaesthetic. The effect is to increase the concentration of other breathed gases in the lung. These include oxygen and volatile anaesthetic agents such as sevoflurane, which are also normally administered along with N2O.

While the second gas effect has been demonstrated previously, by measuring the concentration of volatile anaesthetic in the expired breath, no study has yet shown that it has a significant effect on the concentrations in the blood. The blood concentration is in fact more important, as it directly determines the concentration of anaesthetic reaching the brain, and therefore the effect on the depth of anaesthesia. The second gas effect on blood concentrations may be more powerful than that on expired concentrations, due to the detrimental effect of anaesthesia on the evenness of distribution of ventilation and blood flow in the lung.

The proposed study will have two parallel components or Parts. We wish to i) measure the magnitude of the second gas effects on both blood and expired concentrations of sevoflurane (Part 1), and ii) see if a demonstrable difference exists between the effects on blood and expired concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective surgery requiring relaxant general anaesthesia with arterial blood pressure monitoring via an arterial line.

Exclusion criteria:

* Patients with moderately or severely impaired respiratory disease (FEV1 \< 1.5L, or FVC \< 2.0L).
* Patients under 18 years of age.
* Morbidly obese patients: BMI \> 30
* Patients unable to give informed consent.