cyrilzakka/clinical-trials huggingface dataset:
Measuring sVAP-1 as a Predictor of Pregnancy Problems

Pre-eclampsia is a common pregnancy disorder defined as high blood pressure and protein in the urine after 20 weeks of pregnancy. It affects the function of the placenta and can cause severe complications, e.g, stroke, multiple organ damage and seizures for the mother, and fetal growth restriction or stillbirth for the baby. Pre-eclampsia can also cause long term health problems for mother and baby.

Currently, there is no test that can predict whether someone will develop pre-eclampsia, so nothing is done to intervene before the problems begin.

Results from their previous work suggest that the investigators may have found something that can be measured in a blood sample that can predict which women might develop pre-eclampsia. It is a protein known as Vascular Adhesion Protein-1 (VAP-1), and our evidence points at it being involved in the embryo attaching to the womb and also in helping the development of the placenta by helping to get the right cells to where they are needed.

The investigators will test blood samples from 451 pregnant women who come to the Leicester Royal Infirmary for routine bloods and their first pregnancy dating scan. The investigators will then follow the outcomes of the pregnancy to see if VAP-1 in the blood of women who develop pre-eclampsia (or other pregnancy complications) is different from the ones who do not develop pregnancy complications. The ability to predict women at higher risk of pregnancy complications would ensure the application of timely interventions and appropriate management of the conditions that may help to prevent complications both during pregnancy and later life.

The study is expected to last approximately 30 weeks and the participants will be asked to give one extra tube of blood whilst having their routine bloods taken and to also consent to follow up of medical records until the end of the pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Female participants who are in early pregnancy (\<20 weeks gestational age).
* 16 years and above
* Patient consents to take part in the study

Exclusion Criteria:

* Patient declines to be involved in the study
* Unsuccessful venepuncture
Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis

The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis


Eligibility Criteria:
Inclusion Criteria:

* Subject completed study M02-518 or M02-570

Exclusion Criteria:

* Subject prematurely discontinued study M02-518 or M02-570

  * Female subject who is pregnant or breast-feeding or considering becoming pregnant
  * Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Gut Health and Probiotics in Parkinson's (SymPD)

Current literature suggests that the gut microbiota is altered in patients with Parkinson's disease (PD) and might play a role in the clinical presentation and pathogenesis of this condition. The latter has driven the interest in investigating the use of gut microbiota-modulating interventions, such as probiotics, as possible novel therapeutic strategies for PD. Symprove is a food supplement working as an oral active probiotic which unlike many commercially available probiotics can reach the intestine and has been shown to be beneficial for gut health in gastrointestinal disorders.To date, no research has explored the possible effects of the intake of Symprove in PD. This is an exploratory study with a randomised, double-blind, placebo-controlled design investigating the effects of a 12-week probiotic intervention (Symprove) on gut and general health in 60 patients with PD and constipation.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 and upwards
* Diagnosis of idiopathic Parkinson's disease according to the Movement Disorder Society clinical diagnostic criteria
* Hoehn Yarh stage II-IV
* Diagnosis of constipation according to the ROME IV criteria and ≤ than 3 complete bowel movements per week

Exclusion Criteria:

* Diagnosis or suspicion of other causes for parkinsonism
* Advanced-stage therapies (deep brain stimulation, intrajejunal levodopa infusion, and apomorphine subcutaneous infusion)
* Any inflammatory bowel disease or diseases of the colon
* Previous surgery on the gastrointestinal tract
* History of laxative abuse
* Ongoing artificial nutrition
* Regular use of probiotics
* Previous intolerance and/or adverse reactions to probiotics
* Previous use of Symprove
* Recent or current use of any antibiotics (within 4 weeks before the start of the study)
* Swallowing issues interfering with the safety intake of the probiotic/placebo
* Pregnancy or lactation
* Major systemic disease
* Any condition interfering with the ability to give the informed consent
* Enrolment in another simultaneous investigational trial
Exoskeleton Use in Acute Rehab Post Spinal Cord Injury; a Safety and Feasibility Study

This study will examine the safety and feasibility of using an exoskeleton in subjects who are less than 6 months post spinal cord injury (SCI).

Study participants with acute SCI (\<6 months post injury) will be involved in an indoor, overground walking program.

Locomotor training will include 90 minute sessions (including time to don and doff the device) for 30 training hours (90 minutes, 2-3 times weekly for 8 weeks.)

Eligibility Criteria:
Inclusion Criteria:

* Individuals aged 15 and older with acute SCI (\<6 months post) Etiology of SCI can be traumatic or non traumatic Includes motor complete (AIS A,B) and motor incomplete (AIS C,D) at C7 or below.

Participants must be able to follow 2 step commands Participants must be deemed medically stable by responsible physician or physiatrist

* Spine considered stable by surgeon
* Surgical wound is approximated and surrounding tissue appears healthy
* Participant does not require supplemental Oxygen
* Participant is able to have any IV or other lines disconnected.

Must meet manufacturer's requirements for use of Ekso GT:

Exclusion Criteria:

* Range of motion (ROM) restrictions that would prevent a patient from achieving a normal, reciprocal gait pattern, or would restrict a patient from completing normal sit-to-stand or stand-to-sit transitions Spinal instability Untreated deep vein thrombosis (DVT) Decreased standing tolerance due to orthostatic hypotension Significant osteoporosis that prevents safe standing or may increase the risk of fracture caused by standing or walking Uncontrolled spasticity - score of 3 or higher on modified Ashworth Scale Uncontrolled Autonomic Dysreflexia (AD) Skin integrity issues on contact surfaces of the device or on surfaces that would prohibit sitting (sacrum, greater trochanter, proximal tibia)

Upper leg length discrepancy greater than half an inch (\> .5") or lower leg discrepancy greater than three-quarters of an inch (\>.75") Cognitive impairments resulting in motor planning or impulsivity concerns Pregnancy
Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A randomized double-blind study was conducted to determine whether prophylactic anticoagulation was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator also used logistic regression analysis with variable selection for obtaining the prediction model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical compression, duration of surgery). THA with short duration of surgery did not require prophylactic anticoagulation.


Eligibility Criteria:
Inclusion Criteria:

* Primary total hip arthroplasty

Exclusion Criteria:

* Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded.
* Coagulation related disease and cancer were excluded either.
Metformin and Prevention of Cardiovascular Events in Patients With Acute Myocardial Infarction and Prediabetes (MIMET)

Prediabetes is associated to an increased risk of cardiovascular disease and mortality. Although metformin can delay progression to diabetes there is a lack of RCTs evaluating the effect of metformin on cardiovascular outcomes. MIMET aims to investigate if addition of metformin to standard care has effects on the occurrence of cardiovascular events after acute myocardial infarction in patients with newly detected prediabetes (identified by oral glucose tolerance test, HbA1c or fasting glucose levels).

The study is a national multicenter R-RCT associated to the The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART registry) where participants, after informed consent, will be randomly assigned to either open treatment with standard care + metformin or standard care alone in a 1:1 ratio. Standard care consists of diet and life-style advice according to national guidelines but does not include metformin. Baseline data for individual patients will be collected from the SWEDEHEART registry. Patients will be followed per routine care at 2 and 12 months post index AMI and in addition at a final study visit at 24 months. Laboratory measurements and collection of SAE will be performed yearly. In total n=5150 patients is expected to be followed for major CV event (all-cause mortality, myocardial infarction, heart failure and stroke) by linkage with SWEDEHEART and national health registries.

Eligibility Criteria:
Inclusion Criteria:

I. AMI

II. Swedish citizens with a personal ID number ≥18 years and ≤80 years

III. Newly diagnosed prediabetes:

1. HbA1c 42-47 mmol/mol or
2. Capillary or venous fasting plasma glucose concentration 6.1-6.9 mmol/L or
3. 2-hour post-load capillary glucose concentration 8.9-12.1 mmol/L or
4. 2-h post-load venous plasma glucose concentration 7.8-11.0 mmol/L
5. HbA1c \<48 mmol/mol and 2-hour post-load capillary glucose concentration \>12.1 mmol/L or 2-h post-load venous plasma glucose concentration \>11.0 mmol/L (thus elevated 2-hour glucose levels in the diabetes range but without HbA1c levels diagnostic for diabetes)

IV. Naïve to metformin and other glucose lowering therapy

V. Signed informed consent

Exclusion Criteria:

I. Type 1 diabetes

II. Known type 2 diabetes

III. Indication for glucose lowering treatment

IV. Acute condition with high risk for volume depletion, circulatory shock, hypoxia

V. Serious illness, other than cardiovascular, with short life expectancy

VI. Renal failure (eGFR \<60ml/min)

VII. Hepatic failure

VIII. Malignancy within the last year

IX. Contraindication or hypersensitivity to the study drug

X. Alcohol or drug abuse

XI. Pregnancy or breastfeeding

XII. Women of childbearing potential without adequate anticonception during any part of the study period

XIII. Previous hospitalisation for lactic acidosis

XIV. Predicted inability to comply with the study protocol
A Study to Evaluate the Effect and Tolerance of Musclin™ (Thymol) in Healthy Subjects

This study is to evaluate the effect and tolerance of a thymol containing dietary supplement, Musclin, in healthy adults.

This study will be an open label, uncontrolled, ascending dose clinical trial to assess the tolerance and effect of orally ingested Musclin, 20 mg thymol per capsule, in healthy adult subjects. In addition, this study will evaluate whether Musclin has an effect on creatine kinase and myostatin levels. The study will aim to enroll 20 consenting men and women. Consented subjects will ingest 2 capsules of Musclin daily for 30 days and increase to 4 capsules daily for an additional 30 days . Physical assessments and biological samples will be collected at baseline (day 0) and at end of treatment (d 60). Surveys to include reported stamina and energy levels will be collected at baseline, prior to increased dosage (d 30) and end of treatment period. Risk to participants is expected to be minimal and will be outlined through an informed consent.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy volunteer \> 40 years (adult)
2. Systolic blood pressure 90-140 mmHg upon screening
3. Subject has provided written informed consent
4. Subject is willing to undergo the procedures outlined in this study
5. Subjects BMI is within 18-28.
6. Subjects of childbearing potential must use a hormonal method of birth control, single-barrier method or a double-barrier method of birth control throughout the study or be documented as medically sterile.

Exclusion Criteria:

1. Subject has clinically significant deviation from normal in any organ system.
2. Subject has a clinically significant deviation from normal in any laboratory test except high cholesterol.
3. Pregnant, breastfeeding, or planned pregnancy during the study duration.
4. Known liver, renal or muscle diseases.
5. History of hypertensive or currently taking anti-hypertensive medications.
6. Presence or history of specific heart conditions.
7. Currently taking anti-thyroid or thyroid replacement medications.
8. Currently taking any creatinine kinase lowering drug or supplement.
9. Use of investigational drug within the previous 30 days.
10. Use of herbal supplements, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
11. Known allergies or intolerance to ingredients in Musclin™
12. Any condition which would interfere with the subject's ability to provide informed consent, to comply with study instructions, or which might confound the interpretation of the study results.

    -
The Role of Serotonin in Intensive Care Patients

Sepsis, cardiac arrest and multiple trauma are potentially life-threatening conditions and common reasons for intensive care unit (ICU) admission. The aim of this study is to investigate the role of the signaling substance serotonin in blood in these conditions.


Eligibility Criteria:
ICU-PATIENTS

Inclusion criteria:

* Active treatment of sepsis, septic shock, cardiac arrest with ROSC or severe multiple trauma.
* Age over 18 years
* Written consent from the patient or preliminary consent from the next of kin.
* Receiving mechanical ventilator treatment upon inclusion.
* Arterial and central venous cannulas present.

Exclusion criteria:

* Withdrawal of consent
* Serotonergic carcinoid syndrome, short bowel or other considerable comorbidity altering serotonin content in blood.
* Intoxication prior to ICU admission.

HEALTHY CONTROLS

Inclusion criteria:

* Age over 18 years and signed written consent.
* Conformed to diet and activity restrictions.

Exclusion criteria:

* Any acute illness or injury
* Ongoing autoimmune, malignant, infectious, or other inflammatory disease.
* Severe psychiatric disease or drug abuse.
* Use of any medication except oral contraceptives last two weeks.
* Withdrawal of consent.

ICU CONTROLS

Inclusion criteria:

* Status epilepticus, encephalitis, stroke, or other localized neurological disease.
* Age over 18 years
* Written consent from the patient or preliminary consent from the next of kin.
* Receiving mechanical ventilator treatment upon inclusion.
* Arterial and central venous cannulas present.

Exclusion criteria:

* Withdrawal of consent
* Clinical signs of infection with focal symptoms or temperature over 38,0°C.
* Biochemical signs of infection or inflammation with leukocytes \> 11 x 10\^9/l, CRP \> 15 mg/l, or PCT \> 0,10 μg/l.
* Respiratory failure with PaO2/FiO2 ratio \< 40 kPa.
* Circulatory failure with MAP \< 60 or need for pressor treatment prior to sedation.
* Thrombocytopenia or thrombocytosis with platelets \< 100 or \> 400 x 10\^9/l.
* Serotonergic carcinoid syndrome, short bowel or other considerable comorbidity altering serotonin content in blood.
* Extracranial autoimmune or malignant disease.
* Severe psychiatric disease or drug abuse.
* Intoxication or physical trauma prior to ICU admission.
A Study of the Value of Hybrid PET/MR and PET/CT in Prostate Cancer

According to the latest data from the China National Cancer Center, prostate cancer has become the most common tumor in the urinary system since 2008. However, conventional imaging techniques including transrectal ultrasound , computed tomography and bone scintigraphy are not sensitive or specific. About 40% of resectable lesions cannot be detected by these techniques. Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of prostate cancer. Recently, prostate-specific membrane antigen (PSMA) as a new novel positron tracer has shown to be effective to detect primary lesions, recurrent and metastatic lesions of prostate cancer. In this prospective study, the investigators will use the most advanced imaging equipments, integrated PET/MR, and PET/CT with prostate cancer-specific imaging agent 68Ga-PSMA and conventional imaging agent \[F-18\]fluorodeoxyglucose to image patients with or suspected of prostate cancer, the aim is to explore the value of hybrid PET/MR and PET/CT in prostate cancer.

According to the latest data from the China National Cancer Center, prostate cancer has become the most common tumor in the urinary system since 2008. However, conventional imaging techniques including transrectal ultrasound , computed tomography and bone scintigraphy are not sensitive or specific. About 40% of resectable lesions cannot be detected by these techniques. Positron Emission Tomography (PET) provides a valuable tool for the diagnosis and staging of prostate cancer. Recently, prostate-specific membrane antigen (PSMA) as a new novel positron tracer has shown to be effective to detect primary lesions, recurrence and metastatic lesions of prostate cancer. In this prospective study, the investigators will use the most advanced imaging equipment, integrated PET/MR, and PET/CT with prostate cancer-specific imaging agent 68Ga-PSMA and conventional imaging agent \[F-18\]fluorodeoxyglucose to image patients. For patients suspected of or diagnosed with prostate cancer, the investigators aim to evaluate the roles of integrated PET/MR and PET/CT in differential diagnosis, detecting primary and metastatic lesions, guilding biopsy, staging and determining treatment plan prior to treatment; for the patients with a history of prostate cancer, the aim is to evaluate the value of integrated PET/MR and PET/CT for treatment response assessment, detection of recurrences and metastatic lesions.

Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of or diagnosed with prostate cancer

Exclusion Criteria:

* Acute systemic diseases and electrolyte disorders
* Patients with known malignancy in other organs
* Patients with severe claustrophobia or unstable vital sigh
* Other serious comorbidities evaluated by primary investigator
Safety and Performance of the Trialign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)

The purpose of this study is to assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR) in patients with a minimum of moderate tricuspid regurgitation.

The procedure will be performed with the PTVAS device using a non-surgical percutaneous approach to tricuspid valve repair in patients who have FTR with a minimum of moderate tricuspid regurgitation.

A prospective, single-arm, multi-center study, enrolling symptomatic patients with chronic functional tricuspid regurgitation. The study will include up to 60 subjects from up to 15 sites in Europe and the United States. Follow-up evaluations will be conducted through 5 years post implantation.

Eligibility Criteria:
Inclusion Criteria:

* Chronic functional tricuspid regurgitation (FTR) with a minimum of moderate tricuspid regurgitation;
* ≥18 and ≤85 years old;
* NYHA II, III, or ambulatory IV;
* Symptomatic despite Guideline Directed medical Therapy (GDMT), at minimum, patient on diuretic use;
* patient is at high risk for open heart valve surgery
* LVEF ≥35%
* Tricuspid valve annular diameter ≤55 mm (or 29 mm/m\^2)

Exclusion Criteria:

* Pregnant or lactating female;
* Severe uncontrolled hypertension (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg);
* Previous tricuspid valve repair or replacement;
* Severe coronary artery disease;
* MI or known unstable angina within the 30-days prior to the index procedure;
* Any PCI within 30 days prior to the index procedure or planned 3 months post the index procedure;
* Chronic oral steroid use (≥6 months);
* Life expectancy of less than 12-months
Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine

This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.


Eligibility Criteria:
Inclusion Criteria:

* A male or female between, and including, 6-8 years of age at the time of vaccination,
* Written informed consent obtained from the parent or guardian of the subject,

Exclusion Criteria:

* Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
* Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.
Early Mobilization of Older Adults in the Cardiovascular Intensive Care Unit

An early mobilization (EM) program will be implemented in the Cardiovascular Intensive Care Unit at the Jewish General Hospital (JGH), an academic tertiary hospital in Montreal, Quebec.

The investigators will perform a prospective, pre/post-EM intervention study in adults aged ≥60 years old admitted to the Cardiovascular Intensive Care Unit (CICU) at the JGH. During a 3-month period, the investigators will prospectively enrol patients to the pre-intervention cohort. The EM intervention will then be implemented. During a 12-month period, the investigators will prospectively enrol patients to the intervention cohort. 1 and 12 months following hospital discharge, patients in the pre-intervention and post-intervention cohorts will be contacted by phone by a member of the research team to assess for functional status and quality of life measures.

The primary effectiveness outcome will be the mean improvement in level of function (LOF) during CICU admission and at 1 and 12 months. Covariates predicting improvement in LOF ("responsiveness") and ones which do not ("non-responsiveness") will be assessed. The recovery of physical function at 1 month and 6 months as measured by the SF-36 physical component summary score will be assessed. The SF-36 scores of the highest scoring tertile of LOF on hospital discharge will be compared with the lowest scoring tertile. Hospital readmission at 30 days and discharge home vs. healthcare facility will also be compared. For safety, the composite and individual components of the number of falls, injuries, and dislodgements over the total number of attempted mobility activities will be recorded. The results from the intervention cohort will be compared to the pre-intervention cohort for all results.


Eligibility Criteria:
Inclusion Criteria:

* Participating in early mobilization program
* Age 60 years old or older

Exclusion Criteria:

* CICU stays less than 24 hours
* Patients with prehospital LOF 0 (immobile), LOF 1 (bedbound) or 2 (can sit in chair only).
* Cardiac surgery patients will also be excluded.