cyrilzakka/clinical-trials huggingface dataset:
Relationship Between Adipose Tissue Distribution and Arterial Stiffness in HFpEF

Heart failure with preserved ejection fraction (HFpEF) was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Studies have found that hypertension and obesity are respectively associated with increased arterial stiffness. However, there is still no research investigating the the relationship between lipids distribution and arterial stiffness in HFpEF patients.

Before the 21st century, Heart failure with preserved ejection fraction (HFpEF) was considered as a disease with simple diastolic dysfunction, but after the 21st century, HFpEF was considered as a heterogeneous disease with multi-organ and multi-system design, which is related to various complications, such as hypertension, obesity and arteriosclerosis. Other studies have found that hypertension and obesity are respectively associated with increased arterial stiffness. However, there is still no research investigating the the relationship between lipids distribution and arterial stiffness in HFpEF patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged \>=18years old;
2. Diagnosed with HFpEF.

Diagnostic criteria including:

1. left ventricular ejection fraction ≥50%；
2. with the symptoms and/or signs of heart failure；
3. BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；
4. at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction

Exclusion Criteria:

1. LVEF less than 45% at any time;
2. Severe liver failure; 3/Other causes of shortness of breath, such as severe pulmonary disease or severe chronic obstructive pulmonary disease;

4.Primary pulmonary hypertension; 5.Severe valvular disease of the left heart; 6.Chronically bedridden or incapacitated; 7.Age \<18 years old.
Comparison of OpeN VErsus RoboTic Partial Nephrectomy

A prospective randomized controlled feasibility trial for patients undergoing partial nephrectomy for T1 renal masses at Princess Margaret. Participants will be randomized receive either open or robotic partial nephrectomy.

This is an interventional, unblinded RCT where a total of 30 patients who have consented to undergo partial nephrectomy for a T1 renal mass under the care of a uro-oncologist at Princess Margaret Cancer Centre will be randomized 1:1 to one of two arms:

Arm A: Robotic Partial Nephrectomy Arm B: Open Partial Nephrectomy

Patients will complete all pre-admission testing as per standard of care, regardless of arm allocation. Creatinine and eGFR are measured routinely pre-operatively and these values will be used as a baseline for all patients. In addition to standard pre-admission testing, participants will complete the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) offered either on paper at the visit or online via an emailed link.

Following either open or robotic partial nephrectomy, participants will be followed as per standard of care. Generally, this includes follow-up at 4-6 weeks, 6 months, 12 months and then either every 6 months thereafter or yearly, depending on pathology. All clinical outcome measures for this study are routinely reported post-operatively and in the follow-up period for partial nephrectomy patients. Quality of life will be assessed at the 4-7 week and 6 month follow-up visits using the EORTC QLQ-C30 offered either on paper at the visit or online via an emailed link. Participants will also be asked to complete a Surgical Recovery/Flank Bulge questionnaire regarding their incision healing and recovery from surgery at the 6-month follow-up visit.

The primary objective of this study is to assess the feasibility of a full RCT comparing perioperative outcomes in patients undergoing robotic vs. open partial nephrectomy at the investigator's institution.

The secondary objective of the study is to compare pilot outcome measures addressing oncologic, functional, and health economics outcomes to assess whether a full RCT is worthwhile and feasible.

Eligibility Criteria:
Inclusion Criteria:

* Radiologically characterized T1 renal mass
* Elected for partial nephrectomy surgery
* Under the care of a uro-oncologist at Princess Margaret Cancer Centre
* Willing to comply with follow-up protocol
* Capable of providing informed consent

Exclusion Criteria:

* Radiologically characterized tumours ≥ T1
* Unfit for general anesthetic
* Unsuitable for robotic surgery (determined by treating physician)
* Unwilling to comply with standardized follow-up protocol
* Evidence of metastatic disease
* Solitary kidney
* Previous surgery on affected kidney
* Multiple tumours
* Known genetic syndromes predisposing to multiple renal tumours (e.g., VHL, TS, BHD)
* Pregnancy
* Inability to read, understand, and complete the questionnaires written in English
Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair

Optilene® Mesh Elastic and Ultrapro® Mesh will be used for incisional hernia repair. The primary objective of this clinical study is to demonstrate that Optilene® Mesh Elastic is superior to Ultrapro® Mesh in incisional hernia repair in matter of the physical function score from the SF-36 questionnaire 21 days after mesh insertion. Secondary objectives include the patient's daily activity, the rating of patients pain and the wound assessment determined on several occasions during the six months observation time.


Eligibility Criteria:
Inclusion Criteria:

* Female or male patients \>=18 years
* Female patients are incapable of pragnancy or must be using adequate contraception and are not in lactation
* Patients wiht vertical aponeurotic incisions only
* Incisional hernia with hernia size \>= 3 cm
* Patient is capable to understand and to follow the instructions
* written informed consent
* no mesh implantation at the same site during a previous operation
* immune competence of patient

Exclusion Criteria:

* Simultanous participation in an investigational drug or medical device study
* Patients \< 18 years old
* Incisional Hernia withe a hernia size \< 3 cm
* Repair of an acute incarcerated hernia
* Previous mesh repair at the same site
* Patient with other than vertical aponeurotic incisions
* Enterotomy to be performed during hernia repair at Surgery
* Patient is on anti-coagulations-therapy
* Patient is known or assessed to be non-compliant
* Additional surgical treatment at the same time (e.g. cholecystectomy)
* Immune incompetence of patient (e.g. chemotherapy)
The Intersectional Viborg Screening Program: Cost-(Effectiveness) of Screening for Diabetes and Cardiovascular Diseases

This is an intersectional and interdisciplinary screening program in Viborg Municipality, including 67 years old citizens. This observational study will estimate the cost-effectiveness of a combined screening program for the following conditions: Abdominal aortic aneurysm, peripheral arterial disease, carotid plaque, hypertension, arrhythmia, and type-2-diabetes. Furthermore, the incidence of the outlined conditions will be described and so will the result of the intervention initiated (secondary medical prophylaxis, smoking cessation, introduction to nutritionally deficient diet etc.)

Description of the cohort: All Viborg municipality citizen are invited to the combined screening program around there 67th birthday. Participants with positive screening results are offered following up consultations and prophylactic interventions are initiated (secondary medical prophylaxis, smoking cessation, introduction to nutritionally deficient diet etc.)

67 years-old citizens from the surrounding municipalities without the offer of the combined screening are used as a control group (1 case: 5 controls).

There are no exclusion criteria.

The screening examination includes: Blood pressure in both arms, ankle brachial blood pressure index (ABI), ultrasound for carotid plaque and abdominal aortic aneurysm, HbA1c and pulmonary function test. Furthermore, a questionnaire on lifestyle parameters, BMI, medical history, walking-related pain and self-rated quality of life (EQ-5D).

One year after the screening examination, the participants will receive a questionnaire in order to evaluate the effect from a participant perspective. The cost(-effectiveness) of the screening program will be estimated after 5 years based on prevalence of diseases, response rate, data extraction from nationwide registries and existing evidence of disease prevention.

Eligibility Criteria:
Inclusion Criteria:

All Viborg municipality citizen are invited to the combined screening program around there 67th birthday.

Exclusion Criteria:

There are no exclusion criteria.
The Effects of Acute Ketone Monoester Supplementation on Exercise Efficiency and the Influence of Dose and Intensity

Diet can alter blood ketone levels and this in turn may affect exercise capacity. This study will determine if the acute ingestion of a ketone supplement alters cycling exercise efficiency. Participants will perform three trials in a randomized order. Each trial will involve an incremental exercise protocol on a stationary cycle ergometer to volitional fatigue. Participants will ingest either a high or low dose of a ketone supplement or a taste-matched placebo drink prior to exercise. Blood samples will be obtained to assess selected metabolic responses. This study will provide information regarding the effect of ketone supplementation on exercise efficiency.

This study will determine if the acute ingestion of a ketone supplement alters cycling exercise efficiency. Trained participants with cycling experience will be recruited. Participants will perform three trials in a randomized order. Each trial will involve a 3-minute warm-up followed by an incremental ramp test. The ramp will initially consist of three, 5-minute stages performed at relative workloads corresponding to 75%, 100%, and 125% of individual ventilatory threshold intensity. This will be followed by a further incremental ramp test to volitional fatigue. Participants will ingest either a high or low dose of a ketone supplement or a taste-matched placebo drink prior to exercise using a randomized, double-blind crossover design. Diet prior to exercise will be standardized between trials for a given participant. Blood samples will be obtained to assess selected metabolic responses. This study will provide information regarding the effect of ketone supplementation on exercise efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Be habitually consuming ≥50 g/d of carbohydrate (i.e., not following a ketogenic diet).
* Be engaged in endurance-type exercise \>3h/wk.
* Have an estimated VO2peak of ≥90% for age and sex as estimated by an online calculator found at www.worldfitnesslevel.org.

Exclusion Criteria:

* Experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "Yes" to any question on Page 1 of the Canadian Society for Exercise Physiology Get Active Questionnaire.
B-CD30 + Hodgkin Lymphoma International Multi-center Retrospective Study of Treatment Practices and Outcomes

The purpose of this study is to describe progression-free survival (PFS) in participants with relapsed or refractory classical Hodgkin lymphoma (RRHL), defined as the time from initiation of first treatment for RRHL to first documentation of relapse or disease progression, or death.

This is a retrospective, non-interventional study of participants with newly-diagnosed cHL, or with RRHL. The study will review the medical records of participants to describe participant's demographics, disease characteristics, treatments received, outcomes, health resources used by the participants, and adverse events that are associated with treatments, and resources used for treatment.

The study will enroll approximately 50 to 100 participants in each group at each of the 13 participating countries. Based on the diagnosis of the disease, participants will be assigned to one of the following groups:

Group 1: cHL Group 2: RRHL

This multi-center trial will be conducted in Argentina, Australia, China, Colombia, Hong Kong, Mexico, Republic of Korea, Russia, Saudi Arabia, Singapore, South Africa, Taiwan, and Turkey. The data for Group 1 and Group 2 will be collected from date of cHL or RRHL diagnosis until the date of death (or the date when the participant was last known to be alive, whichever occurs first).

Eligibility Criteria:
Inclusion Criteria:

1. Participants newly diagnosed with high-risk stage IIb-IV cHL (for Group 1) or RRHL (for Group 2) between 01 January 2010 and 31 December 2013.
2. Age greater than or equal to (\>=) 18 years at diagnosis of cHL (Group 1) or RRHL (Group 2).
3. Alive or deceased.
4. Written informed consent is obtained for study data collection, where necessary, according to local regulations.

Exclusion Criteria:

1. Participants for whom the minimum study dataset is not available from their hospital medical records.
2. Participants who have participated in an interventional clinical trial at any stage of their cHL (Group 1) or RRHL (Group 2) management.
A Study to Assess Pulsed Inhaled Nitric Oxide vs Placebo in Subjects With Mild or Moderate COVID-19

A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed inhaled iNO compared to placebo in subjects with COVID-19.

This is a randomized, double-blind, placebo-controlled study to assess the efficacy and safety of pulsed iNO compared to placebo in subjects with COVID-19 who are hospitalized and require supplemental oxygen without assisted ventilation. Subjects will be randomized to receive placebo or iNO125 mcg/kg ideal body weight (IBW)/hour 24 hours daily up to 14 days or until resolution or discharge.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* At least 18 years old
* Subjects must be hospitalized and have the following:

  * proven or high suspicion of SARS-CoV-2 infection and,
  * requiring oxygen supplementation defined as:
  * SpO2 ≤ 92% regardless of supplemental oxygen (ie on room air or on oxygen), or
  * SpO2 ≥ 92% on supplemental O2 and in the opinion of the Investigator it is not safe to decrease or remove the supplemental oxygen
  * require supplemental oxygen of no more than 10 L/minute, and
  * radiologic suspected or proven COVID-19 pneumonitis (chest x-ray or CT scan)
* Female subjects must have a negative pregnancy test
* Willing and able to comply with the treatment schedule and study procedures

Exclusion Criteria:

* Participating in another clinical trial of an investigational treatment for COVID-19
* Methemoglobin \> 3%
* Evidence of severe multi organ failure
* Use of assisted ventilation prior to initiation of iNO
* Pregnancy or positive pregnancy test pre-dose
* Open tracheostomy
* Chronic use of a nitric oxide donor agent such as nitroglycerin or drugs known to increase methemoglobin such as lidocaine, prilocaine, benzocaine, nitroprusside, isosorbide, or dapsone at screening
* History or clinical evidence of systolic heart failure, left ventricular dysfunction (LVEF \<40%)
* Subjects reporting massive hemoptysis associated with the current illness or with radiologically proven pulmonary embolus
Gait Analyses After Resurfacing Hip Arthroplasty Versus Metal on Metal Total Hip Arthroplasty, an Exploratory Study

Total hip replacement surgery is a very successful operation with good long-term results. Hip resurfacing arthroplasty is offered as a treatment option for young and active patients with osteoarthritis of the hip. It has been proposed as a treatment option for younger patients because of claims that it preserves femoral bone stock and has better functional outcomes. The assessment of gait after hip replacement surgery may be able to determine functional differences between patients who have undergone total hip replacement / arthroplasty (THA) versus hip resurfacing.

A group of 58 patients, part of a ungoing randomized trial comparing resurfacing hip arthroplasty to metal-on-metal total hip arthroplasty, will be invited to a single gait analysis on a trendmill. All patients have reached a follow up of five years. Patient 's gait will be assessed during two walking sessions, in both sessions spatio-temporal, kinetic and kinematic parameters will be recorded.

* At first when flat walking with increasing speeds to their top walking speed.
* Secondly: when walking at a fixed speed with an increasing incline to their top walking incline.

Eligibility Criteria:
Inclusion Criteria:

* Patient part of randomised controlled trial (RCT) of hip resurfacing versus MoM total hip arthroplasty for symptomatic osteoarthritis of the hip
* Patient must be able to consent to the study (written informed consent)
* Patients who are functioning well post-operatively and not under routine follow up
* Patients who are able to walk without any safety rail assistance on the treadmill

Exclusion Criteria:

* Patient not originally randomised during an RCT of hip resurfacing versus MoM total hip arthroplasty
* Patients who suffer from any neurological or musculoskeletal conditions that might make a gait test dangerous.
* Patients whose cognitive function prevents them from understanding the study
* Patients who have had or are awaiting revision surgery for their hip
Evaluation of the Effects of Whole Body Vibration on the Lung Function of Patients With Stable COPD

The typical clinical progression of COPD usually results in a decreased level of tolerable physical exertion for the patient. The avoidance of strenuous physical activity leads to a deteriorating level of physical fitness, which further decreases the patient's ability to undertake physical activities. Recent research has shown that whole body vibration has the potential to improve physical fitness of participants, including such measures as the 6 minute walking distance. However, information concerning lung function is lacking.

The goal of the study is to test whether the use of whole body vibration training has an effect on the lung function of patients with stable COPD, or if the previously observed effects can be attributed to either pharmaceutical therapy or physical therapy interventions.


Eligibility Criteria:
Inclusion Criteria:

* Stable COPD (Gold II-IV)
* Signed understanding of participation
* The patients must be able to understand and follow the requirements of participation (Understanding of the German language)

Exclusion Criteria:

* Acute thrombosis
* Hemoptysis
* Implants in the targeted training regions (joint implants)
* Acute joint inflammation, active arthrosis or arthropathy.
* Rheumatoid arthritis
* Acute tendinopathy in the targeted training regions
* Acute hernia
* Acute discopathy
* Fresh fracture in the targeted training regions
* Gall or kidney stones
* Wounds still in the process of healing
* Epilepsy
* Severe neurologic disorders (apoplexy, paralysis of upper and lower extremities)
* Severe circulatory disorders (Cardiac insufficiency NYHA \> or = III, myocardial infarct less than one month prior, circulatory relevant rhythm disorders, idiopathic syncope)
* Tension pneumothorax
* Acute internal bleeding
* Current therapy with fluoroquinolone
* Alcohol/drug/medication abuse
Clinical Study of Bivalirudin for Percutaneous Coronary Intervention (PCI)

Bivalirudin is widely used as an anticoagulant to reduce the risk of bleeding in PCI perioperative period. Additionally, 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (PCI), so bivalirudin was used to anticoagulate in these patients to evaluate its safety and efficacy.

Bivalirudin is a specific reversible thrombin direct inhibitor and the function of thrombin activity site can be recovered through hydrolyzing bivalirudin by thrombin. Therefore, bivalirudin is widely used as an anticoagulant during percutaneous coronary intervention (PCI) for coronary heart disease, and 15.7%-32.7% patients have diabetes mellitus who undergo percutaneous coronary interventions (PCI). At the same time, elderly patients have higher risk of bleeding whose age over 65, so bivalirudin can reduce the risk of bleeding and the incidence of net adverse clinical events for the elderly patients whose age over 65 with diabetes mellitus in PCI perioperative period.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 65 years, with diabetes mellitus.
2. Patients who undergo selective PCI therapy.
3. Patients who agree to participate in this clinical trial and sign informed consent prior to surgery.

Exclusion Criteria:

1. Patients with acute coronary syndrome undergoing primary PCI.
2. Combined with other diseases, the life expectancy of patients don't exceed 1 year.
3. Patients with active bleeding.
4. Bleeding in the gastrointestinal or urogenital tract in the past 6 weeks.
5. Combined with high risk of postoperative hemorrhage, such as active gastric ulcer, active ulcerative colitis, etc.
6. Patients who have undergone major surgery in the last 1 month.
7. A history of intracranial bleeding or structural abnormalities, such as cerebral aneurysms.
8. Patients with cardiogenic shock, or suspected myocarditis, infective endocarditis.
9. Patients who received regular heparin therapy within 6 hours or low molecular weight heparin therapy within 8 hours, or other factors that the researchers believe may influence the outcome of the trial.
10. Patients with severe uncontrolled hypertension.
11. Patients with active hepatitis, HIV and other infectious diseases.
12. Patients with contraindications of bivalirudin and heparin.
13. Other researchers considered the patients are unfit to participate in this study.
Repeatability in Measurements of Two ssOCT and One OLCR Biometer

Achieving high accuracy and precision in ocular biometry has become primordial for cataract surgery, due to the shift of cataract surgery from a rehabilitation procedure to a refractive one.

Aim of this study is to determine the repeatability of ocular biometric parameters obtained using three biometry devices, two ss-OCT biometers and an OLCR device.

Accurate and repeatable biometric measurements are essential in providing an optimal refractive outcome.

ss-OCT biometry uses a tunable wavelength laser source to scan the eye, this technology showing its superiority through better signal-to-noise ratio, the wavelength light source being projected into the eye, one at a time; thus improving tissue penetration.

This a prospective observational study that would include patients which attended pre-surgical examination. A written informed consent will be obtained from each patient.

Only one eye from each patient will be included in the study. All patients included in the study will undergo biometric measurements in a random fashion with the three devices (IOLMaster 700, Lenstar LS 700 and Anterion Heildelberg). Each patient will be measured three times with each device and between the measurements they will be asked to blink or keep their eyes closed for tear film recovery and to avoid fatigue. Scans that pass the quality requirement of each device will be taken for analysis.

Eligibility Criteria:
Inclusion Criteria:

* 40 years old or above
* age-related cataract

Exclusion Criteria:

* patients with dense cataract or corneal pathology that would significantly influence biometric measurements
* nystagmus or pathologies that would affect patient fixation
* pregnancy- for women in reproductive age a pregnancy test will be performed.