cyrilzakka/clinical-trials huggingface dataset:
Right Ventricle Lipid in Pulmonary Arterial Hypertension (PAH)

The investigators propose to study the relationship between right ventricle (RV) steatosis and RV function, exercise capacity, and outcomes in humans with pulmonary arterial hypertension (PAH) and to identify potential drivers of lipid accumulation.

The investigators propose to test the hypothesis that abnormal lipid metabolism in PAH leads to delivery of fatty acids in excess of RV oxidative capacity, resulting in steatosis and lipotoxicity. The objectives of the study are to: 1) Define the relationships between RV steatosis, RV function, and exercise capacity; 2) Identify mechanistic drivers of RV steatosis including BMPR2 expression and lipid metabolism; 3) Examine lipid metabolism in PAH skeletal muscle as a potential driver of reduced functional capacity.

In Aim 1 (clinical relevance) the investigators will measure RV and left ventricle (LV) lipid in participants with heritable, idiopathic, and scleroderma- associated PAH. Participants will undergo the 6-minute walk test, cardiopulmonary exercise testing, and will be followed for clinical events. A subgroup will undergo repeat MRS at four timepoints over three years to determine the natural history of steatosis.

In Aim 2 (mechanism), the investigators will perform metabolomic/lipidomic profiling of peripheral and coronary sinus plasma and measure BMPR2 expression to identify potential drivers of steatosis.

In Aim 3 (specificity), the investigators will perform MRS on skeletal muscle in Aim 1 participants and matched healthy controls to clarify the systemic effects of lipid metabolic defects in PAH.

Eligibility Criteria:
Inclusion criteria:

* ≥ 18 years old
* Diagnosed with idiopathic, heritable, connective tissue disease-associated PAH, associated pulmonary arterial hypertension (PAH), or drug-or toxin-associated PAH according to World Health Organization (WHO) consensus recommendations.
* Stable PAH-specific medication regimen for three months prior to enrollment. Adjustments in IV prostacyclin for side effect management are allowed. Diuretic adjustments are permitted.
* WHO Functional Class I-III
* Ambulatory
* Able to have an MRI/MRS, perform a 6MWD test, and cardiopulmonary exercise test

Exclusion criteria:

* Pregnancy
* Diagnosis of PAH etiology other than idiopathic, heritable, connective tissue disease - associated PAH or associated with drugs and toxins
* WHO Functional class IV heart failure
* Requirement for continuous oxygen
* Unable to have an MRI/MRS, perform a 6MWD test, or cardiopulmonary exercise test.
* Patients with implanted/embedded ferromagnetic material that would preclude cardiac MRI
Long-term Outcome of General Anesthesia on Dysgnosia

Cognitive disorders in patients underwent general anesthesia are discussed for decades, but whether there were precise relationship between general anesthesia and dysgnosia is yet to be guaranteed. Although controversial data reported from experimental studies in animals, the investigators still proposed that general anesthetics could impair the normally organized system of the central nervous system, which finally displayed a dysfunction of cognition after general anesthesia in a short- or long-term period. Therefore, different types of general anesthetics such as inhalational anesthetics and intravenous anesthetics, the investigators hypothesized, had a long-term influence on patients' cognitive ability.


Eligibility Criteria:
Inclusion Criteria:

* Patients with informed consents
* Without basal disorders of neurology and psychiatrics

Exclusion Criteria:

* With the history of cognitive disorders
* With chronic neurological disorders
* Cannot communicate with investigators
* Cannot stand general anesthesia
Burden of Cervical Cancer in Tanzania

Cervical cancer screening is a worldwide problem especially in the developing world of which Tanzania belongs. It is diagnosed late in the third world because there are no diagnostic facilities and resource people. It occurs in the age groups between 40 and above and therefore affects the productive age of the community. It is well known that women generally are the backbone of every community and specifically in the developing countries.

The objective of this research is to analyze and quantify the burden of cervical cancer disease in the community. It will research the interpersonal and socioeconomic issues associated with cervical cancer disease in the family.


Eligibility Criteria:
Inclusion Criteria:

* new pathological diagnosis of cervical cancer

Exclusion Criteria:

* non consenting individuals
Effects of Intact and Disrupted Milk Fat Globule Membrane on Postprandial Metabolic Response to High-fat Dairy in Healthy Individuals

The aim of the study is to investigate the effects of milk fat globule membrane (MFGM) content and intactness on postprandial metabolic response to a high-fat meal in humans.

The investigators hypothesize that MFGM content and intactness alters the postprandial lipid profile and substrate metabolism in healthy individuals after consumption of a high-fat meal.

The subjects will be invited for four visits in total: one screening visit and three test days separated by a one-week washout period. At the test days, subjects will consume two high-fat meals composed of milk fat with intact MFGM, destroyed MFGM, and without MFGM, respectively. The first meal will be consumed as breakfast and the second meal will be consumed as lunch. Test meals will be isocaloric and with similar macronutrient composition. The meal will consist of a sandwich with a butter-like dairy product.

The three trial days will be completely alike, besides the interventions.

Subjects will arrive at the research lab the night before test day and stay inside a metabolic chamber to acclimatize.

The participants will have one intravenous (iv.) access placed in the elbow on the three trial days where blood samples will be collected at 15, 30, 60, 90, 120, 150 and 180 min after each test meal (breakfast and lunch).

Immediately after consuming each of the two test meals, the subjects will take 1,500mg paracetamol to determine ventricular emptying rate using the acetaminophen test. After this, the subjects can lay in the bed and watch TV, iPad, or work on their laptop.

Before and every hour after consumption of the test meals, the subjects will be asked to fill out an appetite questionnaire (visual analogue scale). At the end of the day the participants will be offered an "ad libitum meal" to measure if MFGM content and intactness influences ad libitum intake of calories at the next meal.

An one-way mixed model of linear regression will be used to compare postprandial area under the curve, ventricular emptying, and ad libitum food intake between the three test days. Secondary outcomes will be analyzed using a two-way mixed model of linear regression with repeated measurements.

Based on the results from a previous study that investigated the effects of the fat and protein structure in dairy products on postprandial triglycerides (20), the investigators will need 11 subjects to detect a 15% decrease in postprandial triglyceride AUC (α=0.05, β=0.80). To account for potential missing values, 12 subjects will be included in total.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* Written and informed consent
* HbA1c \< 48 mmol/l

Exclusion Criteria:

* Medicine with an impact on blood glucose, lipid profile, or blood pressure and birth control pills
* BMI \> 30kg/m2
* Affected screening blood sample as evaluated by the clinical responsible investigator
* Severe claustrophobia
* Lactose intolerance
* Doesn't speak and understand Danish
* Commitment to special diets
Phase 1 Study of Relative Bioavailability of PPI-668 New Tablet Versus Capsule Formulations

This study will compare the blood levels of PPI-668 resulting from two different formulations - the current capsule and a new tablet, T003.


Eligibility Criteria:
Inclusion Criteria:

* Have the ability to understand and sign a written informed consent form
* nonsmoker
* body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive)
* HIV-1 antibody negative.
* hepatitis B (HBV) surface antigen negative.
* hepatitis C (HCV) antibody negative.

Exclusion Criteria:

* Pregnant or lactating subjects.
* Have any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematologic, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central or peripheral nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), or immunodeficiency disorders, active infection, or malignancy that is clinically significant or requiring treatment.
* Have participated in an investigational trial involving administration of any investigational compound within 30 days prior to the study dosing.
* Current alcohol or substance abuse judged by the Investigator to potentially interfere with subject compliance.
* Have poor venous access and unable to donate blood.
* Have donated blood within 56 days of study dosing.
* Have donated plasma within 7 days of study dosing.
* Have taken any prescription medications or over-the-counter medications including herbal products within 28 days of commencing study drug dosing with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or contraceptive medications.
Two Fluid Strategies for Prevention of Post-dural Puncture Headache

Postdural puncture headache (PDPH) is a common complication after cesarean delivery (CD). The role of peri-operative fluid therapy in prophylaxis against PDPH is unclear. The aim of this work is to compare restrictive versus liberal fluid therapy in prophylaxis against PDPH after CD

In this study, the investigators will compare restrictive fluid therapy and liberal fluid therapy in prophylaxis against postdural puncture headache.

The restrictive group will not receive preoperative fluid loading, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour for hours. The Liberal group will receive preoperative fluid loading of 5 mL/Kg, and will receive intraoperative crystalloids at rate of 10 mL/Kg/hour, followed by postoperative crystalloids at rate of 6 mL/Kg/hour.

Both groups will be compared regarding demographic data, total peri-operative fluids, incidence of postdural puncture headache, nausea, vomiting, and intraoperative hemodynamics (heart rate and systolic blood pressure) in addition to neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Full term
* Pregnant female
* Scheduled to elective cesarean delivery

Exclusion Criteria:

* History of migraine headache
* Hypertensive disorders of pregnancy
* Cardiac morbidities,
* Baseline systolic blood pressure \< 100 mmHg
* Contraindication of regional anesthesia.
* Patients with more than one single attempt for spinal block
Lime Powder Regimen in Healthy Volunteers

The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in Thai healthy men.


Eligibility Criteria:
Inclusion Criteria:

* Thai healthy male or female aged 18-45 years old
* BMI 18-25 kg/m2
* Normal medical history, physical examination and vital signs
* Normal screening laboratories
* no history of drug allergies
* Willingness to take part in the study and provide informed consent

Exclusion Criteria:

* History of GI, liver, kidney, allergic disease or any other disease that may interfere with the bioavailability of lime powder regimen
* History of alcohol or drug abuse
* Heavy smoking
* Receive any medication within 14 days prior to the study day
Genotype-phenotype Association in Hereditary Hemorrhagic Telangiectasia

The present project aims to study the inflammatory and endothelial responses involved in the differences in clinical events related to both genotypes (ENG vs. ACVRL1) in HHT. Accordingly, a cross-sectional study is proposed to evaluate the differences in circulating inflammatory and endothelial biomarkers, including interleukines, adhesion molecules, chemokines and immune regulatory molecules between both HHT groups.

Background and rationale: Hereditary Hemorrhagic Telangiectasia (HHT) is a rare disease characterized by a multisystemic vascular dysplasia with autosomal dominant inheritance, mainly caused by mutations in ENG and ACVRL1 genes. Even though those mutations have been related to different clinical manifestations, the molecular mechanisms involved in each genetic variant have not been clarified. Methods: A cohort study will be carried out to compare the incidence of clinical events after a 12-months follow-up. The ability of these biomarkers to predict the clinical events will be assessed in a multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years.
* Confirmed diagnosis of HHT, according to the Curaçao criteria or genetic diagnosis.
* Clinically stable condition at the time of inclusion, defined as score \< 7 points on the Epistaxis Severity Score (ESS).
* Having signed the informed consent, after having received all the information concerning the study.

Exclusion Criteria:

* Major coronary or cerebrovascular event in the 3 months prior to inclusion.
* Serious intercurrent illnesses, such as acute infections, outbreaks of autoimmune or inflammatory pathology, active cancer, or other pathologies that, at the investigator's discretion, could interfere with the conduct of the study.
* Major surgery during the 2 months prior to inclusion.
* Pharmacological treatment maintained during the 3 months prior to inclusion with NSAIDs, corticosteroids or chemotherapy.
* Toxic habits, including severe smoking, alcohol or drug abuse, which in the opinion of the investigator could interfere with the conduct of the study.
* Pregnancy or puerperium.
* Any other condition that limits compliance with the visits or procedures established in the protocol.
Isoflavone Treatment for Postmenopausal Osteopenia.

The aim of the project is to execute a double-blind, parallel, randomized 12-month intervention trial on postmenopausal women with osteopenia (low bone mineral density), in order to determine the effects of daily intake of fermented red clover (RC) extract on estrogen dependent bone mineral resorption when compared to placebo. Both groups will recieve equivalent daily calcium, vitamin D and magnesium supplements. The project will also assess whether bioactive compounds in RC can reduce the risk of developing cardiovascular disease.

The project aims to determine whether red clover derived isoflavones have capabilities to exert positive effects in conditions of osteoporosis and osteopenia in states estrogen deficiency and/or dysregulation.

The cause of osteopenia in women is thought to arise from the deficiency of and/or dysregulation by estrogen on target tissues. Hormone Replacement Therapy (HRT) has proven to be an effective treatment, however it retains limited use as there is general consensus that it also increases cancer risk. Plant derived compounds that emulate the chemical structure and behaviour of estrogen (known as isoflavones) offer a compelling alternative to HRT, due to their potential to adopt the regulatory roles of estrogen without incurring equivalent negative side effects of HRT.

There are, at present, few or no direct head to head clinical trials assessing combination treatments of isoflavones, vitamin D and calcium in contrast to standard vitamin D and calcium supplementation proscribed to osteopenic patients. Research in this area will therefore provide valuable insight into the effectiveness of isoflavones to reduce resorption and/or to stimulate the formation of bone tissue. Moreover the study will provide a comprehensive assessment of the potential of isoflavones to enhance the efficacy of existing preventative treatments. Outcomes of the project have the prospect to help thousands of middle aged and PM women suffering. Moreover, the project may enable development of functional foods and/or nutraceuticals that can be used as either a preventative measure and/or as a treatment for osteoporosis in states of estrogen deficiency and thereby provide an alternative to Hormone Replacement Therapy that does involve the same side effects and risks.

Eligibility Criteria:
Inclusion criteria:

* Age 50-85 years, only women
* Have osteopenia (T score between -1 and -2.5)
* Body Mass Index (BMI) between 20 and 40

Exclusion criteria:

* Taken specific osteoporosis drugs (i.e. bisphosphonates, PTH, estrogen or strontium ranelate) in the past 3 months
* Taken other selective estrogen receptor modulator preparations (raloxifene, tamoxifen or isoflavones) in the past 3 months
* Participation in other clinical trials within the last 3 months
* Previous history of cardiovascular, psychiatric, neurological, and / or kidney disease
* Alcohol or substance abuse or acute illness
* Blood pressure\> 160/110
* Pregnant and breastfeeding women
Impact of Aluminum on Sperm DNA Quality

Between 1950 and 2013, aluminum production was multiplied by thirty in the world. Today, men's exposure to aluminum, including food products, cosmetics, air and water contamination, and a number of drugs (vaccine, gastric bandages, etc.) has never been so high and should continue to increase. At the same time, we are witnessing a decline in male fertility in Western countries.

In this context, several teams, including ours, have studied the impact of aluminum on the fertility of men. These studies have shown that aluminum accumulates in semen and especially in sperm near its DNA.

Aluminum has already shown that it is capable of damaging the DNA of various cells, especially to increase DNA fragmentation. We therefore hypothesize that aluminum could lead to increased sperm DNA fragmentation. This would result in a decrease of men fertility and in higher risk of miscarriage.

In order to confirm this hypothesis, this study aims to dose aluminum in the spermatozoa of 80 patients who perform artificial insemination and correlate this result to their sperm DNA fragmentation. Patients will be recruited from the reproductive biology unit of Saint-Etienne University Hospital. Aluminum assays will be carried out using an Atomic Absorption Spectrophotometry technique by Prof. Exley at Keele University in Great Britain, a world expert in aluminum toxicity. Measurements of sperm DNA damage will be carried out using flow cytometry by our research team (SAINBIOSE INSERM U1059) at the Medecine Faculty of Saint-Etienne.

Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated to a social security scheme
* Patient who perform his first artificial insemination
* Patient who is 18 years old or more

Exclusion Criteria:

* Patient having expressed his refusal to participate in the study after information on the protocol and delivery of an information notice.
* Patient for whom the total quantity of spermatozoa is not sufficient for separation by ascending migration (in this case all the spermatozoa from the pellet are used for the insemination)
* Patient under justice protection (guardianship)
A Study to Investigate the Safety, Tolerability, and Pharmacodynamics of JNJ-54175446 in Participants With Major Depressive Disorder

The primary purpose of this study is to investigate the safety and tolerability of JNJ 54175446 in participants with Major Depressive Disorder (MDD).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) must be between 18 and 32 kilogram per square meter (kg/m\^2) inclusive
* Related to symptoms of depression: Participant must meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV or V diagnostic criteria for Major Depressive Disorder \[MDD\] (International Classification of Diseases (ICD)-code F32.x and F33.x), without psychotic features, as confirmed by the MINI 6.0; participant must have an IDS-C30 total score greater than or equal to (\>=) 30 using the semi-structured interview guide for the IDS-C30
* Participant is, during this episode of depression, treatment naïve OR treated with at most one Selective serotonin reuptake inhibitor (SSRI) over a minimum of 6 weeks and a maximum of 6 months, and subject is being treated at an adequate dose, showing a partial response at enrolment
* A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test upon admission
* A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug

Exclusion Criteria:

* Has a primary DSM-IV or V diagnosis of general anxiety disorder (GAD), panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa. Participants with comorbid GAD, social anxiety disorder, or panic disorder for whom MDD is considered the primary diagnosis are not excluded
* Has a length of current major depressive episode greater than (\>) 24 months despite adequate treatment
* Has failed more than 2 treatments with a different pharmacological mode of action despite an adequate dose and duration during a previous, or the current depressive episode
* Participant has a history of substance use disorder according to DSM-V criteria, except nicotine or caffeine, within 6 months before Screening. However, participants who have completed a treatment for (alcohol) addiction more than 8 weeks prior to first dose administration and are under continuous control of the study center, may be included if the risk to fall back is considered minimal and no significant abnormalities are shown in clinical laboratory or other predose safety assessments
* Obstructive sleep apnea/hypopnea (apnea/hypopnea index \>10) or restless legs syndrome (periodic leg movements with arousal index \>15) as assessed on the first or second polysomnography (PSG) recording during screening
GlideScope Video Laryngoscope Versus Fiberoptic Intubation

Following informed consent, patients will be randomly assigned to oral fiberoptic intubation or to oral intubation using the GlideScope Video Laryngoscope. Following the induction of general anesthesia a sealed envelope would be opened to reveal the technique to be used. A stop watch will be started at the beginning of the procedure. At the completion of intubation the stop watch will be stopped and the time recorded along with other data. Based on a sample size estimation process, it is the investigators plan to study fifty patients. The two techniques will be compared in terms of the average time needed to place the endotracheal tube and studied using a two-sided T-Test with a significance level of 0.05. To ensure comparability between the two methods, all intubators will be required to have at experienced at least 10 uses of the GlideScope and 10 uses with fiberoptic intubation.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* scheduled for elective surgery requiring orotracheal intubation.

Exclusion Criteria:

* known, difficult airway
* loose teeth
* pregnant
* require a rapid sequence induction,
* Body Mass Index under 30
* unable to give consent
* if special endotracheal tube (ETT) is needed for the case.