cyrilzakka/clinical-trials huggingface dataset:
Prognostic Hemodynamic and Metabolic Profiles of Late Stage Lower Extremity Arterial Disease

Late stage lower extremity arterial disease (LEAD) is known to be associated with hemodynamic and metabolic abnormalities and very poor long-term prognosis. The prognostic value of hemodynamic and metabolic profiling, however, is yet to be determined in this patient group.

Current study aims to identify novel prognostic biomarkers for better risk stratification of late stage LEAD patients. It also allows to determine associations between hemodynamic/arterial stiffness indices, low-molecular weight metabolites and other substances (e.g. mediators of inflammation and bone-mineral metabolism, cardiac and kidney injury biomarkers, microRNAs) thus providing potentially valuable insight into the pathogenic mechanisms of this disease.


Eligibility Criteria:
Exclusion Criteria:

* Fontaine stage I-IIa;
* acute limb ischemia;
* age \<35 or \>85 years;
* fasting \< 6 hours;
* time since the last use of tobacco products \< 4 hours;
* body mass index ≥ 40 kg/m2
* blood pressure ≥ 180/120mmHg;
* unstable angina;
* atrial fibrillation at the time of presentation;
* myocardial infarction, stroke or TIA during the preceding 3 months;
* any revascularization during the preceding 1 month;
* severe heart failure (NYHA IV);
* clinically significant heart valve disease;
* severe physical disability (other than limb ischemia);
* acute infectious disease;
* active malignancy or chemotherapy or disease-free \< 5 years;
* type 1 diabetes;
* uncompensated thyrotoxicosis/hypothyroidism or other clinically significant endocrine disorders;
* moderate to severe asthma (GINA 2016);
* severe chronic obstructive pulmonary disease (mMRC grade 3-4)
* acute (KDIGO 2012) or chronic renal disease (eGFR-EPI \<30mL/min/1.73 m2);
* clinically significant acute or chronic liver disease;
* severe anemia (\<80 g/L);
* clinically significant neuroinflammatory or neurodegenerative disease;
* active rheumatism;
* clinically significant connective tissue disease;
* alcoholism or drug abuse;
* psychotic disorders
Use of the Leva Incontinence System in Treating Bladder Incontinence.

This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.


Eligibility Criteria:
Inclusion Criteria

* Subjects must be female.
* Subjects must be capable of giving informed consent.
* Subjects should be at least 18 years of age and less than 89 years of age
* Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys.

Exclusion Criteria:

* Absence of a vagina.
* Positive drug or alcohol test at the screening visit.
* Post-menopausal defined as absence of a period for over 12 months.
* Pregnancy or being less than 12 months post-partum.
* Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure).
* Symptoms of stage II or greater pelvic organ prolapse.
* BMI \>31 kg/m2.
* Diagnosis of any neurological disorder.
* Prior lower back or pelvic surgery, including prior surgery for stress urinary incontinence (SUI).
* Prior pelvic radiation.
* Current or recurrent vaginal infections (\>three per year).
* Painful bladder syndrome, active or chronic pelvic pain.
* Concurrent Pelvic Floor Muscle Exercises (PFME) under a supervised therapeutic plan of care.
* Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the treatment for urinary incontinence or any other pelvic floor disorder.
* Currently taking medication to treat incontinence.
* Impaired cognitive function.
* Unable to tolerate use of the leva device.
Long-Term Outcome Following Regenerative Periodontal Treatment of Intrabony Defects

Many years ago, periodontal regenerative treatment has been done in Periodontics and Oral Medicine Clinic, Faculty of Dentistry, Mahidol University, Bangkok, Thailand. However, there is still lacking of study about long-term result of periodontal regenerative treatment of intrabony defects.

Beside, in the present, some materials for periodontal regenerative treatment are still expensive. Periodontists and patients have to plan together based on not only rationale of treatment but also cost and effectiveness. Thus the long-term result of treatment could be useful for the decision making.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received regenerative therapy of the intrabony defects
* Patients who had the record of re-evaluation at 1 year post-surgery

Exclusion Criteria:

* Patients who received regenerative therapy involving the furcation area
* Patients who received non-periodontal regenerative therapy
* Patients who received endodontic regeneration
* Patients who had an incomplete periodontal data recording
Effect of Pirfenidone on Glomerular Filtration Rate and Albuminuria in Patients With Diabetic Nephropathy

It is estimated that approximately 30% of patients with diabetes develop diabetic nephropathy. Diabetic nephropathy is a multifactorial progressive disease that occurs through various mechanisms such as hyperglycemia, oxidative stress, inflammation and fibrosis, control or blocking these mechanisms are therefore potential therapeutical targets for this entity. Current treatment options are based on the glycemic control, blood pressure control, as well as the use of medications such as angiotensin-converting enzyme inhibitors and Angiotensin II receptor antagonists, these actions are not enough to stop progression. Pirfenidone is a drug with antifibrotic, antioxidant, and anti-inflammatory properties. Although the specific mechanism is unknown, pirfenidone interferes with the expression, secretion and the effect of the β (TGF-β) transforming growth factor. The investigators plan to carry out a controlled clinical study to evaluate the effect of pirfenidone in patients with type 2 diabetes and nephropathy. The period of time the treatment will be administered will be of 12 months, 62 patients will be included. The primary outcome will be improvement in glomerular filtration rate. The secondary outcomes will be number of patients requiring replacement therapy, 24 hour urine microalbuminuria and change in the concentration of TGF - β. Change in these parameters will be evaluated at the end of the treatment period (12 months). Throughout the study the incidence of adverse events will be recorded, wich will allow us to learn about the safety and security of the drug in this population.


Eligibility Criteria:
Inclusion criteria

* Body mass index (BMI) less than 35 kg/m2
* Diagnosis of diabetes mellitus type 2
* Glomerular filtration rate of 15-89 ml/min
* Albuminuria ≥30 mg/24 h and \< 3.5 g/24 h
* Individuals with blood pressure less than 140/90 mmHg or treated with stable doses of anti-hypertensive drugs.
* Glycated hemoglobin \<10%

Exclusion criteria

* Another etiology of renal disease (autoimmune diseases, polycystic kidney disease)
* Repeated urinary tract infections (more than three episodes in the past year)
* Photosensitivity to any drug
* Liver disease
* Pregnancy
* Breastfeeding
Functionality and Neurocognition in Patients With Bipolar Disorder After a Physical-exercise Program (FINEXT-BD Study)

This is a study that aimed to deep in the physiopathology of BD and see how, through potential modifiable areas of the patients' lifestyle, the prognosis and evolution of the pathology can be improved.

Randomized interventionist study (ratio 1:1) with two parallel branches, blinded by evaluators (the evaluator does not know the branch of treatment to which the patient belongs )to evaluate if an individualized moderate-to-vigorous physical exercise intensity program as adjuvant therapy to standard drug therapy will improve the functional and neuropsychological status of patients with Bipolar Disorder. The effectiveness of the intervention will be assessed by an extensive battery of clinical tests, physical parameters (e.g. brain structure changes measured by optical coherence tomography) and biological parameters (inflammation, oxidative stress and neurotrophic factors).

The total sample of the study will be 80 patients and a sample of 40 controls (individuals without psychiatric pathology). The sample of patients will be divided into 40 patients in each group at random. In the intervention group, a supervised physical exercise treatment by high-intensity interval training (HIT) will be performed during 16 weeks with 2 sessions per week (32 sessions in total).Three visits will be made in both groups: baseline visit at the beginning of the study, at 4 months (at the end of the intervention) and at 10 months (6 months after the end of the intervention)

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with bipolar disorder type I according to the criteria of the DSM-5 manual, diagnosis made by structured interview SCID-P.
* The study includes patients with first episode and multiple episodes. At the beginning of the study they must be in euthymia, that is, there will be no current diagnosis of manic, hypomanic or depressive episode. Relapses during follow-up and the presence of subindromial symptoms at any time will not result in exclusion from the study.
* Patients may be treated with any treatment according to clinical guidelines.
* Age: 18-65 years
* Speak Spanish correctly
* Informed consent for the study of the patient

Exclusion Criteria:

* Presence of organic diseases of the central nervous system (CNS) or history of head trauma with loss of consciousness
* Intellectual disability.
* Acute inflammatory disease
* Treatment with anti-inflammatory drugs during the week prior to sample taking
* Pervasive developmental disorders.
* Pregnancy and lactation
Saccadic Reaction Time and Preterm Pre-eclampsia

This study is recruiting two groups of women over the age of 18; those who are pregnant and who have pre-eclampsia; and those who are pregnant but do not have pre-eclampsia. The aim is to test a new method of diagnosing and monitoring pre-eclampsia and thus prevent the long-term damage it can cause to the baby's health. Untreated, pre-eclampsia can lead to seizures in pregnancy (eclampsia) and may prove fatal for mother and child.

Currently the only effective treatment for pre-eclampsia is control of the mother's blood pressure until it is safe to deliver the baby. The timing of delivery is kept under constant review by the medical team, who must balance the risk to the mother of developing eclampsia against the risk to the baby of being born too early (premature).

If pre-eclampsia can be diagnosed early, there is a greater chance of being able to treat it effectively. We know that women with pre-eclampsia often have exaggerated reflexes in their limbs (hyperreflexia) and that this may be linked to the risk of seizures. Measuring these reflexes might therefore be a useful way to diagnose and monitor pre-eclampsia, but doing this is not easy, so we want to assess whether measuring other reaction times might similarly help assess the risk of seizures. One possibility is by measuring the reaction time as we flick our eyes to follow a moving target, using an instrument called a saccadometer, which is worn on a head-band, a little like a head-torch.

By comparing the results between these groups and the non-pregnant women, we will be able to see if reaction times from the saccadometer are altered in women with pre-eclampsia, and, if so, whether saccadometry might be useful in helping doctors decide the best time for safe delivery.

Prospective feasibility study with two arms; (i) case-control comparisons of saccadic reaction time distributions between patients with preterm pre-eclampsia, age- and gestation-matched pregnant controls and age-matched female non-pregnant controls \[cross-sectional analysis\]; (ii) intra-individual comparisons of antenatal and postnatal saccadic reaction time distributions of patients with preterm pre-eclampsia \[longitudinal analysis\].

Eligibility Criteria:
Inclusion criteria for cases:

1. Age ≥ 18 years
2. Confirmed diagnosis of pre-eclampsia, as defined by the International Society for the Study of Hypertension in Pregnancy (ISSHP)
3. Gestational age \< 35+0 weeks
4. Participant is willing and able to give informed consent

Inclusion criteria for controls:

1. Age ≥ 18 years
2. Absence of essential hypertension and pre-eclampsia or pregnancy-induced hypertension in current and previous pregnancies
3. Gestational age \< 35+0 weeks
4. Participant is willing and able to give informed consent

Exclusion Criteria:

1. Maternal neurological or psychiatric disorder (e.g. epilepsy, migraine, multiple sclerosis, depression, etc.)
2. Use of medication (other than vitamin supplements \[cases and controls\] and those for treatment or prevention of pre-eclampsia \[cases\]) during pregnancy
Naturopathic-pharmacological Consultation in Hematology

The goal of this cross-sectional study is to learn about the effect of a naturopathic-pharmacologic consultation in patients with hematologic conditions. The main question it aims to answer is whether such consultation can improve the safety of dietary and herbal supplements' use among these patients.

Participants will be asked to answer basic questions and fill-out questionnaire before and after meeting the consultation team. Some patients will be prescribed dietary and herbal supplements that may help relief some of the symptoms they describe, in a safe way and without interacting with the drugs they are taking.


Eligibility Criteria:
Inclusion Criteria:

1. Followed up for a hematological condition
2. Ability to fill simple questionnaires in Hebrew, Russian or Arabic
3. Indication for consultation:

   1. Patient's request to expand knowledge about the use of DHS
   2. Patient using DHS
   3. Patient's desire to start using DHS
   4. Patient that is interested in hearing about the use of DHS for his/her health condition
   5. Medical or nursing team's recommendation to take DHS for medical treatment or to improve compliance with conventional treatment.

Exclusion Criteria:

None
Oleuropein and Muscle Energy Metabolism

Preclinical studies performed at Nestlé Research (NR) identified oleuropein as a novel activator of mitochondrial calcium import. This potentiated mitochondrial calcium uptake resulted in decreased phosphorylation of the enzyme pyruvate dehydrogenase (PDH), which is linked to its activation as a rate limiting enzyme for mitochondrial oxidation, as well as increasing mitochondrial oxygen consumption, resulting ultimately in decreases in muscle fatigue. In addition, NR demonstrated that during aging, mitochondrial calcium and oxygen consumption rates are decreased in isolated skeletal muscle fibers. The next step in the evidence development is to demonstrate efficacy of oleuropein for improved muscle energy and decreased physical fatigue in a healthy aging population.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. 50 to 70 years old
3. BMI 18.5-29.9 kg/m2
4. Healthy as per medical history and investigator's/ physician's judgement
5. Having given informed consent

Exclusion Criteria:

1. Allergy/intolerance to the study product
2. \>5% body mass change in the previous 3 months
3. HbA1c ≥ 6.5%
4. Blood pressure \>140/90 mmHg
5. Participating in a structured (progressive) exercise program
6. Smoking
7. Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes
8. Diagnosed musculoskeletal disorders
9. Chronic use of gastric acid suppressing medication
10. Unauthorized concomitant medications such as calcium antagonists (e.g. valproate), oral corticosteroids, anything that will prevent subjects from safely completing the study according to the investigator or medications / drugs known interfering with the expected mechanism of action of IP or to affect the outcome parameters
11. Alcohol (intake higher than 3 servings per day. One serving is 0.4 dl of alcohol, 1 dl of wine, or 3 dl of beer) or drug abuse
12. Overly imbalanced or restrictive diet (e.g. hyperproteic, vegan, ketogenic, etc.)
13. Subjects not willing and/or not able to comply with scheduled visits and the requirements of the study protocol
14. Any implants that would be a contra-indication for performing an MRI scan.
15. Participation in another study at the same time
16. Blood donation in the past 2 months
Oxandrolone Compared With a Placebo on Growth Rate in Girls With Growth Hormone-Treated Turner's Syndrome

RATIONALE: Turner's syndrome is a disease in which females are missing all or part of one X chromosome and do not produce the hormones estrogen and androgen. Giving growth hormone may help girls with Turner's syndrome attain a more normal height. It is not yet known if growth hormone is more effective with or without oxandrolone for Turner's syndrome.

PURPOSE: Randomized phase II trial to study the effectiveness of oxandrolone in girls who have growth hormone-treated Turner's syndrome.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomly assigned to recombinant human growth hormone (GH) and oxandrolone versus GH and placebo.

GH is administered by daily subcutaneous injection and oxandrolone is given every day by mouth. Treatment continues for 3 years; estrogen is offered after year 2.

A study duration of 8 years is anticipated.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Turner's syndrome-compatible karyotype No Y material in peripheral karyotype Bone age no greater than 11 years --Prior/Concurrent Therapy-- No more than 12 months of prior estrogen, androgen, or growth hormone
Effect of Allergen Challenge on Inflammation Induced by Toll-like Receptor Stimulation in a Nasal Model

Asthma is one of the most common diseases affecting about 2.5 million Canadians, and can result in reduced quality of life and difficulties with work and school. Once the disease has become established with irreversible changes in the lungs it can be very difficult to treat. Severe asthma although less common than mild asthma uses more healthcare resources.

The objective of this project is to find out how the changes in the lung develop in severe asthma. Once this is known then new treatments can be developed to prevent irreversible damage to the lungs.

Volunteers will have substances sprayed up their nose and then samples collected from their nose. Levels of proteins and cells can be measured in these samples. This will give an indication of the type of inflammation that occurs.

The usual method of investigating the changes that occur in asthma is to challenge the lungs. Samples have to then be collected from the lungs. This can be in the form of sputum which must be treated to break it down to a liquid or washed out during a camera test. These methods cause problems with measuring proteins and they are broken down or diluted. Because the nose is easily accessible samples can be obtained at many time points. Because the samples can be collected directly from the nose the problems with obtaining samples from the lung are avoided.


Eligibility Criteria:
Inclusion Criteria:

* 1 Subjects over the age of 18 2 Subjects able to give written informed consent 3 Subjects able to comply with study procedures and protocol 4 Subjects with a history of allergic asthma 5 Subjects with a positive skin prick test to a common aeroallergen 6 Subjects who are otherwise healthy with no other health problems

Exclusion Criteria:

1. Subjects with a viral URTI within 2 weeks prior to screening.
2. Subjects with a TNSS\> 2 at screening
3. Subjects with a structural nasal abnormality or nasal polyps on examination, a history of frequent nose bleeding, nasal surgery within the previous 3 months.
4. Subjects who are a current smoker or have a history of smoking within the previous 3 months.
5. Subjects who have used a medication that could affect responses to nasal challenge (eg corticosteroids, decongestants, anti-histamines) or any other nasally applied medication within 2 weeks prior to screening.
6. Subjects who have participated in any other clinical trials within the previous 3 months.

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Gender of Anesthesiologist and Time to Labor Epidural

The goal of this retrospective cohort study is to learn about wether the gender of the anesthetist affects time to epidural anesthesia (EDA) for laboring women . The main questions it aims to answer are:

1. Is there a gender difference in time to applying EDA
2. What is the mean waiting for EDA in laboring women in Sweden

Participants (anesthesiologists) will be reviewed according to the time from when the midwife asks for EDA to anesthesiologist register that it was in place

In certain hospital in Sweden, a module on the most contemporary Obstetric chart system in Sweden allows for registration of time from request of EDA to applied EDA.Time of request is made by the midwife and the Tim of application is registered by the anesthesiologist. Not all hospitals makes these registrations, thus only (i)hospitals having this module and (ii) hospitals willing to participate will be included.

Eligibility Criteria:
Inclusion Criteria:

* Registered maternal request of epidural/spinal anesthesia anesthesia

Exclusion Criteria:

* Not possible to determine gender by first name or by personal knowledge at participating site
* Duplicates
* Misregistered time-points of EDA
* Not receiving EDA (even if the initial intention was to apply EDA)
* Uncertain which anesthesiologist that registered the time-point (more than one anesthesiologist involved in documentation or application)
* None/ambiguous documentation of time-points
Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement

Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time.

A new dual cured cement which is amine free is introduced so the investigators have to try it clinically using parallel groups in randomized clinical trial.


Eligibility Criteria:
Inclusion Criteria:

All subjects are required to be:

* From 18-60 years old, and able to read and sign the informed consent document
* physically and psychologically able to tolerate conventional restorative procedures
* Have no active periodontal or pulpal diseases, have teeth with good restorations
* Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ....)
* Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth
* Patient with fractured teeth of more than 50% enamel loss
* Patients with poor oral hygiene and motivation
* Pregnant women
* Psychiatric problems or unrealistic expectations
* Lack of opposite occluding dentition in the area intended for restoration