cyrilzakka/clinical-trials huggingface dataset:
Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure

Heart failure (HF) is a complex condition resulting from structural or functional heart diseases that impair the ability of the heart to fill with or pump out blood. The main manifestations of HF are shortness of breath and tiredness which may limit the ability to exercise or perform simple daily physical activities such as walking. Heart disease leading to HF is associated with reduced muscle mass and reduced strength and low blood levels of testosterone; a hormone normally produced by the human (male and female) body. Recent studies have shown improvements of symptoms and ability to exercise in patients with heart failure receiving testosterone.

This is a placebo controlled study to determine the efficacy and safety of low dose testosterone (300 and 450 microgram/day) delivered by a transdermal system (patch) in women with significant HF.


Eligibility Criteria:
Inclusion Criteria:

* Female 50 years of age or older; post-menopausal (≥ 12 Mo/ from last menstruation)
* Documented left ventricular ejection fraction (LVEF) of 20-40% within 90 days prior to the baseline visit
* History of HF for more than 90 days and a diagnosis of symptomatic HF (Class III NYHA) for at least 30 days prior to the baseline visit
* Ambulatory (i.e., able to walk without assistance of another person or device such as cane or walker)

Exclusion Criteria:

* Neuromuscular or rheumatologic conditions that limit the to their ability to improve walking distance
* Pulmonary edema or multiorgan failure or cardiogenic shock within 30 days prior to the baseline visit
* Congenital heart disease, infiltrative myocardial disease
* Unstable angina or myocardial infarction within 30 days prior to the baseline visit
* Undiagnosed abnormal genital bleeding
* History of breast cancer, breast surgery, or breast disease contraindicating estrogen/hormone therapy
* Polycystic ovary syndrome or any other condition known to be adversely affected by testosterone treatment
* Resting heart rate \> 120 bpm
* Systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg
* Known or suspected hypersensitivity or allergy to any adhesive or to any of the components of the testosterone transdermal system (TTS)
* Use of SERMS, SARMS, SPRMs, tibolone, testosterone, estrogen, progesterone agonists and antagonists or taking any prescription and over the counter medications/ nutraceuticals (eg, phyto-estrogens) that may have anabolic or steroid hormonal effects within 30 days prior to the baseline visit
* Use of marketed or investigational oral, sub-lingual, topical, transdermal injectable, or vaginal androgen therapy including dehydroepiandrosterone (DHEA) at any time within 3 months prior to the baseline visit
* Use of systemic corticosteroids within 30 days prior to the baseline visit (acute use for fewer than 7 days is acceptable)
Exercise Tolerance and Lower-limb Muscle Power in Patients With Chronic Respiratory Disease

The aim of this study is to validate the six minute Stepper Test (6MST) and the 5-repetition chair lift test (5STS) as measures of exercise tolerance and muscle power, respectively, in patients with chronic respiratory disease.

As the reproducibility of the tests has been studied and validated in previous studies, the objective is to investigate the validity of the 6MST and 5STS in comparison with their respective gold standards.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 and over
* With a diagnosis of chronic obstructive pulmonary disease (GOLD II - IV) or pulmonary fibrosis (\>6 months).
* Able to understand and follow verbal instructions during tests
* Affiliated with a social security scheme
* Willing to participate in the study

Exclusion Criteria:

* Have a neurological, cardiovascular or balance disorder that could impair test performance.
* Having undergone respiratory rehabilitation within the last year.
* With unstable disease (recent exacerbation \< 4 weeks).
* Pregnant and/or breast-feeding women
* Patients under guardianship or curatorship
A Study to Demonstrate Bioequivalence Between 6 x 2 mg Tablets of Perampanel and a Single 12 mg Tablet of Perampanel in Healthy Subjects

The purpose of this study is to investigate the bioequivalence between 6 x 2 mg tablets and one 12 mg tablet of perampanel in healthy subjects.

A Single Centre, open label, 2-period, 2-sequence crossover bioequivalence study in one group of 28 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects aged between 18-55 years.
* BMI of 18-32 kg/m \^2.
* Willing and able to provide written informed consent.

Exclusion criteria:

* Subjects taking prescribed or over the counter (OTC) medications in 2 weeks prior to screening.
* Subjects on special diets or dietary aids known to modulate drug metabolizing enzymes.
* Subjects who have taken inhibitor of CYP450 within 2 weeks of first dose.
* Subjects who have received any experimental drug in the 12 weeks prior to study drug treatment.
* Subjects with a history of alcohol abuse or who drink more than the recommended number of alcohol units per week.
* Subjects who consume more than five caffeinated beverages per day.
* Subjects who smoke more than 5 cigarettes per day.
* Subjects with a history of drug abuse or who have a positive urine drug screening test.
* Women who do not agree to use two methods of contraception.
Prolactin Hormone in Oral Lichen Planus

Oral lichen planus (OLP) is one of the most common mucosal diseases with autoimmune etio-pathogenesis with involvement of various cytokines similar to psoriasis.It generally occurs more commonly in females, in a ratio of 3:2. prolactin (PRL),It is a peptide hormone that has a role in autoimmune related diseases like systemic lupus erythematosus and , rheumatoid Artheritis. The role of PrL in OLP pathogenesis was never investigated.the aim of this study is to investigate the expression of PRL receptors in tissue biopsies of OLP patients.


Eligibility Criteria:
Inclusion Criteria:

* patients with oral lichen planus
* systemically healthy

Exclusion Criteria:

* oral lichenoid lesions
Children's Health Study Diet and Air Pollution

This study is built upon the existing data in the Children's Health Study to examine the longitudinal association between childhood exposure to air pollutants and changes in diet among adolescents.


Eligibility Criteria:
Inclusion Criteria:

* children of 4th and 7th grades were enrolled from 12 Southern California communities

Exclusion Criteria:

* extreme mean caloric intake (\>5000 or \< 500 kcal/day) or no demographic information
The INTER-CARDIO Study: The Impact of Commonly Consumed Fat on Cardiovascular Health; a Randomised Controlled Trial

The purpose of this study is to investigate whether there are differences in postprandial cardiometabolic metabolic indices following interesterified fats used commercially versus application appropriate non- interesterifed alternative fat.

Aim: The current study aims to investigate the acute effects of commercially available interesterified fat versus versus application appropriate non- interesterifed alternative fat on 8 h postprandial cardiometabolic outcomes.

Hypothesis: Interesterified fat will induce a different cardiomtabolic response compared to a non interesterifed, application appropriate fat.

Subjects: Participants will include 40 healthy male and female volunteers aged between the ages of 35 and 75 years (since during this age metabolic changes start to take place).

Power calculation: Based on previous studies carried out by our group at King's College London, a sample size of 20 participants (males and females separately) will allow a 2.16% (percentage unit) difference in FMD to be detected (90% power, 0.05 alpha, SD 2.9. 50 participants will be recruited allowing for a 20% dropout rate.

Expected value:The study will provide novel information on the acute effects of commercially relevant processed fats on postprandial lipaemia.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 35-75 years
* Healthy (free of diagnosed diseases listed in exclusion criteria)
* Able to understand the information sheet and willing to comply with study protocol
* Able to give informed consent

Exclusion Criteria:

* Medical history of myocardial infarction, angina, thrombosis, stroke, cancer, liver or bowel disease or diabetes
* Body mass index \< 20 kg/m2 or \> 35 kg/m2
* Plasma cholesterol ≥7.5 mmol/L
* Plasma triacylglycerol \> 3 mmol/L
* Plasma glucose \> 7 mmol/L
* Blood pressure ≥140/90 mmHg
* Current use of antihypertensive or lipid lowering medications
* Alcohol intake exceeding a moderate intake (\> 28 units per week)
* Current cigarette smoker (or quit within the last 6 months)
* ≥ 20% 10-year risk of CVD as calculated using a risk calculator
A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer

The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Women ≥ 20 years
* Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast

Exclusion Criteria:

* Number of prior chemotherapy lines of treatment in the metastatic setting ≥3
Joint Coordination to Facilitate the Transition From Sick Leave to Employment

GESAM is a randomized controlled intervention study that addressed women and men on long-term sick leave in Uppsala County. Participants which are on sick leave due to mental illness and/or pain and were expected to reach the time limit within the in health insurance will be offered to participate in an intervention.

Those how give informed consent will be randomly assigned one of the following groups: 1) informing and motivating intervention with insurance officer 2) control group. The main purpose of the study is to facilitate the return to work (preventing a return to the public health insurance) during the project period.


Eligibility Criteria:
Inclusion Criteria:

* On sick leave
* Risk of losing sick leave compensation

Exclusion Criteria:

* Major mental illness (schizophrenia, bipolar disorder type I, severe social dysfunction/personality disorder)
* Cancer disease
Effectiveness of Educational Intervention on Footcare Among Individuals Having Type 2 Diabetes at Slums of Karachi, Pakistan.

There are multiple studies conducted in Pakistan that supports the topic of foot care knowledge among individual with type 2 diabetes but all are descriptive cross-sectional studies and investigators cannot develop cause effect relationship out of it. Secondly, there is a lack of documented research on the foot care knowledge shown by people with T2D residing in the slums of Karachi. In order to assess the knowledge intervention among the individual having T2D through qualified diabetes educators and pictorial educational pamphlet along with the standard care of treatment. Consequently, it may aid in the development of effective methods aimed at mitigating foot-related complications among this specific population. Individuals diagnosed with diabetes are required to engage in proactive and structured self-care activities by providing the foot care knowledge in order to effectively manage their condition and mitigate the risk of potential complications. The incorporation of health-deviation knowledge and activities into routine is crucial.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients aged 18 years or older.
* Patients who are registered at designated SINA clinic and clinical and biochemical diagnosis of DM for at least six months
* Patients who are able to understand Urdu language will be included in the study
* Patients who are voluntarily participated the study will be included.

Exclusion Criteria:

* Patients come with recurrent foot ulcers or gangrene.
* History of amputation
* Patient live in other than designated slums location.
External Validation of the VExUS Score for the Prediction of Acute Renal Failure in Cardiac Surgery

Acute renal failure is a frequent complication associated with significant morbidity and mortality in postoperative cardiac surgery.

The VExUS (Venous Excess UltraSound grading system) score was created to qualitatively assess this venous congestion, based on ultrasound data from patients obtained post operatively in cardiac surgery. These data included: inferior vena cava diameter, Doppler flow of the suprahepatic veins, portal trunk and renal veins.

This score is predictive of the onset of acute renal failure in the first 3 days after surgery.

The VExUS score has not been validated in an external and prospective way in cardiac surgery.

Acute renal failure is a frequent complication associated with significant morbidity and mortality in postoperative cardiac surgery.

The pathophysiology in this context is complex, poorly understood and the causes are multiple: underlying nephropathy, intra- or postoperative haemodynamic instability, the use of an extracorporeal circulation, inflammation, etc.

One of the other possible etiologies is venous congestion. This may be due to volume overload and/or isolated global or right heart dysfunction.

Early treatment could prevent the onset of ARF or reduce its consequences, hence the importance of being able to predict its onset.

The VExUS (Venous Excess UltraSound grading system) score was created to qualitatively assess this venous congestion, based on ultrasound data from patients obtained post operatively in cardiac surgery. These data included: inferior vena cava diameter, Doppler flow of the suprahepatic veins, portal trunk and renal veins.

This score is predictive of the onset of acute renal failure in the first 3 days after surgery.

The VExUS score has not been validated in an external and prospective way in cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled cardiac surgery
* Affiliated to a social security system

Exclusion Criteria:

* Emergency surgery
* Chronic renal failure defined by a glomerular filtration rate of less than 30ml/min or dialysis.
* renal transplant recipients
* Cirrhosis and portal hypertension
* Setting up a left ventricular assist device implantation
* Patient under ECMO (ExtraCorporeal Membrane Oxygenation), intra-aortic balloon pump, or a mechanical circulatory support device such as IMPELLA
* No available operator to perform ultrasound scans
* Patients objecting to the use of their data in research
* Subject under guardianship or subject deprived of freedom
* Pregnant or breastfeeding women
* Resume surgery within 48 hours of scheduled surgery
* Lack of a trained operator to perform D+1 and D+2 ultrasound
An Expanded Access Program to Axitinib is Available for Patients With Advanced Forms of Kidney Cancer (Ductal; Papillary; Chromophobic; Oncocytic) With Mutations in VHL, PBRM1 / BAP1, SETD2, VEGF)

Kidney cancer belongs to a heterogeneous group of tumors and is the most common oncourological disease; up to 80% of cases are clear cell carcinoma.

The study of rare hereditary forms of clear cell kidney cancer (CRP) made it possible to identify the VHL gene, germline mutations which lead to the development of the Hippel-Lindau syndrome, and somatic mutations are characteristic of sporadic CRP. The second most frequent mutation independent of VHLmut is the PBRM1 gene involved in chromatin remodeling. PBRM1 mutations are positively correlated with SETD2 mutations and negatively correlated with BAP1 mutations. Depending on the status of PBRM1/BAP1 mutations, tumors are characterized by different pathomorphological features and prognoses. The main stages of the clonal evolution of SRP, which is already at the early stages and is characterized by pronounced intratumoral genetic heterogeneity, have been determined. However, as PRP progresses, subclones acquire different secondary mutations that contribute to the activation of the same mTOR and VEGF signaling pathways, as well as disrupting the mechanisms of chromatin remodeling and the functioning of TP53. The present program will determine the efficacy of standard doses of axitinib in patients with differentiated mutations in kidney cancer following partial exome sequencing.

Eligibility Criteria:
Inclusion Criteria:

* Histologically documented metastatic renal cell cancer or cell kidney cancer
* Evidence of measurable disease.
* Adequate renal function (serum creatinine level)
* ECOG Status 0-1
* Patient must provide signed informed consent
* Male or female, age \>/= 18 years

Exclusion Criteria:

* Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors
* Current use or anticipated need for treatment with drugs that are known as potent CYP3A4 or CYP1A2.
* Active gastrointestinal bleeding.
* Severe allergic reactions
* Unwillingness or inability to comply with mandated pretreatment biopsy or therapeutic regimen
Natural History of the Leukodystrophies

The purpose of this study is to:

1. define novel homogeneous groups of patients with LDs and
2. work toward finding the cause of these disorders.

Patients with leukodystrophies (LDs) of unknown etiology are a heterogeneous group but constitute the second largest group of genetic white matter diseases. In order to find the cause of leukodystrophies, patients with LDs of unknown cause will be analyzed clinically, neurophysiologically, biochemically and genetically. Patients would have been diagnosed as having no known leukodystrophies at outside centers. At the Baylor University Medical Center, such patients will undergo a series of neuropsychological, blood, urine, spinal fluid, radiological, and peripheral tissue pathological tests. Some of these tests will be part of a standard battery while others will be tailored to individual patients. Patients will be followed yearly or as necessary. Patients will be screened for mutations in genes coding for structural myelin proteins. In some patients in whom all tests yielded no information regarding the etiology of their disease, and in whom there is evidence to suggest involvement of the peripheral nervous system, a sural nerve biopsy will be considered. Sural nerve biopsy tissue will be evaluated using a novel combination of approaches including detailed pathological, immunohistochemical, and biochemical analysis of myelin proteins and lipids. Schwann cell biology and expression of myelin genes in the brain will also be investigated in situ. It is hoped that the present study will help clarify the nosology of the leukodystrophies and significantly advance our understanding of the pathogenesis of these diseases.

Eligibility Criteria:
Inclusion Criteria:

Subjects must:

* have clinical and radiographic signs of leukodystrophy without a specific etiology
* no diagnosis of adrenoleukodystrophy, adrenomyeloneuropathy, metachromatic leukodystrophy, Krabbe disease, Canavan disease, a well-defined amino acid organic acid disorder, or a systemic mitochondrial cytopathy.
* First-degree relatives of patients with leukodystrophies of unknown etiology (father, mother, siblings, or sons and daughters of the patients)
* Be able to travel to Baylor University Medical Center in Dallas Texas for evaluation and spend 5-8 working days on site
* Be able to tolerate a general exam and neurological exam
* Be able to tolerate a modest amount of blood drawing, provide a urine specimen, and have a skin biopsy(if not previously done)
* Be able to tolerate the performance of necessary neuroimaging studies to include EEG and Head MRI
* Be able to tolerate a neuropsychological testing and rehabilitation evaluation
* Be able to tolerate spinal tap or nerve biopsy if needed

Exclusion Criteria:

* Unable to travel to Baylor University Medical Center in Dallas Texas for evaluation
* Refusal to sign a study consent form
* Unable to tolerate the performance of the required testing
The EU Hyprotect Registry

European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery


Eligibility Criteria:
Inclusion Criteria:

* Consenting adult patients (≥18 years)
* Patient is scheduled for elective major non-cardiac surgery under general anesthesia that is expected to last at least 120 minutes and in whom blood pressure is monitored using an arterial catheter
* Patients in whom the AcumenTM Hypotension Prediction Index software with the Acumen IQ sensor on the Hemosphere platform is used intraoperatively

Exclusion Criteria:

* Patients undergoing emergency surgery OR nephrectomy, liver and/or kidney transplantation
* Patients suffering from atrial fibrillation and/or sepsis (according to current Sepsis-3 definition)
* American Society of Anesthesiology (ASA) physical status classification V or VI
* Disability and/or other circumstances under which the patient is not able to understand the nature, significance and scope of the investigation
* Pregnancy at the time of surgery
* Patients without signed informed consent / data protection statement
* Patient participating in other interventional trials
Safety and Effectiveness of IHAT in Iron Deficient Pre-menopausal Woman

This is a double blind, randomised, placebo-controlled trial to evaluate orally-dosed IHAT (iron hydroxide adipate tartrate) at 2 different doses compared to placebo for increasing serum ferritin levels in iron-deficient but otherwise healthy premenopausal women over 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy iron deficient pre-menopausal women
* Iron deficiency defined as Serum ferritin \< 30 ug/L (1)
* Generally healthy defined as C-reactive protein \< 3 mg/L (1)
* Subjects adhering to a vegetarian or vegan diet are allowed
* Agree not to give blood donations during the study
* Able to provide informed consent
* Agree not to participate in another clinical trial while enrolled in this trial
* Agree not to change current diet and/or exercise frequency or intensity

Exclusion Criteria:

* Anaemia (as determined from the haematocrit and haemoglobin measures) (2)
* Previously told they have an iron absorption problem
* Subjects regularly taking iron specific supplements during or 2 months prior to study commencement (the use of other mineral/vitamin/herbal preparations is allowed but should be recorded) (3)
* Any uncontrolled serious illness (4)
* Receiving/prescribed coumadin (Warfarin), heparin, dalteparin, enoxaparin or other anticoagulation therapy
* Active smokers, nicotine use, alcohol(5) or drug (prescription or illegal substances) abuse
* Chronic gastrointestinal disorders
* Pregnant/lactating women or women trying to conceive
* Diagnosed depression or mental disorder that is uncontrolled
* Eating disorders
* BMI \> 35 kg/m2
* Allergic to any of the ingredients in active or placebo formula
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
* Participants who have participated in any other clinical trial during the past 1 month

Footnotes

1. A blood test is required prior to enrolment into the study to receive trial product. Participants will be required to attend a local pathology collection centre and have serum ferritin and CRP within the required limits to be considered enrolled in the study and be provided with trial product.
2. Anyone considered to be anaemic will be excluded and directed to their GP. In women, anaemia is defined as any of the following: Haemoglobin \< 115 g/L, Haematocrit \< 35%.
3. Potential participants that are taking supplements that would result in their exclusion must wait an 8-week washout period prior to commencing the study.
4. An uncontrolled illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
5. Chronic past and/or current alcohol use (\>14 alcohol drinks/week).