cyrilzakka/clinical-trials huggingface dataset:
The Significance of Circulating Microvesicles in Pulmonary Hypertension Due to Chronic Obstructive Pulmonary Disease

Mild to moderate pulmonary hypertension is a common complication of chronic obstructive pulmonary disease (COPD); such a complication is associated with increased risks of exacerbation and decreased survival. A small proportion of COPD patients may present with severe pulmonary hypertension, defined by a mean pulmonary artery pressure more than 35 mmHg (or more than 20 mmHg with a low cardiac index \< 2 l/min/m2) with pulmonary vascular resistance more than 3 Wood units, measured by right heart catheterization (RHC). In these patients, pulmonary microvessels remodeling is the main cause of increase in pulmonary arterial pressure and is thought to result from the combined effects of hypoxia, inflammation, and loss of capillaries but the mechanisms are complex.

For these patients, no drugs have been approved for treatment and lung transplantation must be considered for the more severe patients who are eligible. A better characterization of these patients is needed.

We hypothesize that microvesicles generation and endothelial damage could be related to the severity of pulmonary hypertension due to COPD, assessed by pulmonary hemodynamic parameters. Circulating biomarkers of vascular damage and cell activation will be measured in blood samples from 80 COPD patients who have hemodynamic assessment by RHC. To go further, the origin of the particles will be characterized.


Eligibility Criteria:
Inclusion criteria:

* Age ≥ 18
* COPD: obstructive ventilatory insufficient on spirometry and history of smoking
* patients who will perform right heart catheterization
* Signature of written informed consent

Exclusion criteria:

* LVEF \< 45% (echocardiography)
* Post-capillary pulmonary hypertension (pulmonary capillary wedge pressure \> 15 mmHg)
* Chronic Thromboembolic hypertension
* Pulmonary embolism \< 6 months
* Acute coronary syndrome \< 3 months
* Significant cardiac valvulopathy (echocardiography)
* Portal hypertension
* Connective tissue disease
* chronic renal insufficient (clearance \< 40 ml/min)
* Glycated hemoglobin \> 7% (if diabetes)
* Non controlled arterial hypertension
* Positive beta-HCG
* Respiratory exacerbation during the inclusive period
* Patients under guardianship or curatorship
Dual Therapy With Raltegravir and Darunavir/Ritonavir in HIV Infected Patients.

While 3-drug regimens remain standard of care, concerns exist regarding the safety of multi-drug regimens taken for a lifetime. Problems with nucleoside analogue therapy prompted successful trials with ritonavir (RTV) boosted PI monotherapy, however long term safety and efficacy of such regimens remains unknown. Clinical trials have shown Raltegravir (RAL) to have potent activity when patients have few active background drugs; it has a superior lipid profile compared with EFV and LPV/RTV. Darunavir/r (DRV) is a potent, well tolerated PI with few GI side effects and lipid disturbances and with a high genetic barrier. The investigators hypothesized that RAL/DRV would be a well tolerated and effective regimen for those patients who are failing nucleoside reverse transcriptase inhibitors based regimens, due to poor tolerability or resistance. The investigators also would like to explore the plasma pharmacokinetics of Raltegravir combined with Darunavir in a sub-group of 12 HIV-infected patients.

Hypothesis

* NRTI-sparing regimens are attractive options to avoid NRTI-associated toxicity and to provide a full active regimen in patients with some extent of NRTI resistance.
* Raltegravir (RAL) and Darunavir (DRV) are potent "third drugs" and they provide a synergistic inhibition of 2 different steps in HIV replication.
* DRV has a high genetic barrier, and could be an excellent accompanying drug for Raltegravir, providing a potent, safe and well tolerated dual therapy to patients who are failing NNRTI based treatments.

Objectives:

* To describe the safety, tolerability and efficacy of the combination of Raltegravir and Darunavir after 24 weeks of follow up in HIV infected patients failing a NRTI based regimen.
* To describe plasma pharmacokinetics of Raltegravir when combined with Darunavir 800mg QD in HIV-infected patients.

Eligibility Criteria:
Inclusion Criteria:

* Documented HIV infection
* Naïve to Raltegravir.
* CD4 cell count above 200 cell/mm3.
* No history of failure to PI containing regimens.
* No evidence of PI mutations (IAS-mutation list) by genotype test.
* Failing to a NRTI based regimen.
* The treating physician decides a NRTI sparing regimen which includes DRV/r 800/100 mg QD plus Raltegravir 400 mg BID.
* Signed informed consent form
* In opinion of the investigator, the patient should be considered clinically stable and could follow regular visits as scheduled per protocol.

Exclusion Criteria:

* Patients receiving drugs considered contraindicated to Raltegravir and DRV/r. Contraindicated drugs are: rifampin, fenitoin, phenobarbital in the case of raltegravir. Pravastatin, astemizole, sildenafil, are contraindicated in combination with DRV/r.
* Pregnancy
* Documented PI mutations
A Population-based Investigation of Related Factors of Birth Weight in China

The purpose of this study is to establish Chinese neonatal network to investigate current situation of neonatal birth weight and related factors. We investigated the risk factors such as sex, gestational age, region, nation, altitude, place of residence, maternal occupation, education level of mother, maternal age, maternal pregnancy diseases and multiple births.


Eligibility Criteria:
Inclusion Criteria:

* live births
* Gestational age between 24 weeks and 43 weeks

Exclusion Criteria:

* Major malformation
* Physical deformity
* Fetal edema
* Body mass diagnosed in prenatal ultrasound
* Acute blood loss during delivery
Music for Dementia-related Sleep Problems

The study aims to evaluate the effect of listening to music at bedtime on sleep in elderly persons with dementia and sleep problems.

The study is a clinical trial to assess the effect of music listening as intervention for improving sleep in elderly persons with dementia and sleep problems. We use a within-subject design to evaluate the effect of the music intervention. Participants are persons above the age of 60 diagnosed with dementia and suffering from sleep problems. We will examine the effect of the intervention on sleep, mood and cognition.

Eligibility Criteria:
Inclusion Criteria:

* Dementia
* Sleep problems

Exclusion Criteria:

* Use of hypnotic medications
* Substance abuse
* Severe hearing deficits
* Not out of bed during daytime
Plasma Exchange in Patients With COVID-19 Disease and Invasive Mechanical Ventilation: a Randomized Controlled Trial

Plasma exchanges with 5% human albumin (2/3 of the exchanged plasma volume) and fresh frozen plasma (FFP: 1/3) in patients with quick \<50% or only with 5% albumin in patients with quick of 50% or more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit.

Plasma exchange (PE) is a standardized and safe therapeutic procedure, used in the treatment of various diseases that require rapid and prolonged elimination of endogenous and exogenous substances, with deleterious effects on the function of different organs and systems. The efficacy and safety of PE has been demonstrated in patients with fulminant hepatitis (FH), an entity characterized by an exacerbated inflammatory response, multi-organ failure, and high short-term mortality. In FH, plasma exchange improves systemic inflammation, prevents organ failure and renal support requirements, and improves survival. Such treatment eliminates important endogenous and exogenous inducers of the systemic inflammatory response (PAMPs and DAMPs), proinflammatory mediators (cytokines and ROS), and other biologically active substances (nitric oxide, prostaglandins, and bradykinin) that are involved in the pathogenesis of organ failure. Several case reports also suggest that PE is an effective rescue therapy in critically ill patients with influenza A (H1N1). However, the efficacy of PE has not been evaluated in critically ill patients with COVID-19 disease.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female subject ≥18 years and \< 80 years of age;
2. Subjects with diagnosis of COVID-19 disease by PCR in nasopharyngeal smear, sputum, or bronchial aspirates;
3. Subjects admitted in ICU with invasive mechanical ventilation;
4. Informed consent granted via telephone by relatives or legal representative

Exclusion Criteria:

1. More than seven days with invasive mechanical ventilation
2. Refractory Shock (Noradrenaline dose \> 0.5 micrograms/ kg/minute)
3. Decompensated Cirrhosis
4. Chronic kidney disease requiring hemodialysis
5. Active neoplastic disease
6. Severe chronic heart failure (NYHA class III or IV)
7. Severe pulmonary disease (GOLD III or IV)
8. HIV infection (AIDS criteria)
A Crossover Study to Evaluate the Efficacy of Simvastatin in Elevating HDL-C Levels in Patients With Type 2 Diabetes (0733-216)(COMPLETED)

The purpose of this study is to see how well simvastatin raises HDL levels in patients with Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patient has stable Type 2 diabetes mellitus at Visit 1.
* Patient meets screening criteria based on Visit 1 lab tests

Exclusion Criteria:

* Patient is pregnant, breastfeeding, or at risk of becoming pregnant
* Patient has heart disease, uncontrolled high blood pressure, or other significant disease
* Patient is taking prohibited medication(s) and is unable to stop taking them for the duration of the study
Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea.


Eligibility Criteria:
Inclusion Criteria:

* Male or female who is at least 18 years of age or older.
* A clinical diagnosis of facial rosacea.
* A Clinician Erythema Assessment (CEA) score of ≥3 at Screening and at Baseline (prior to study drug application).
* A Patient Self Assessment (PSA) score of ≥3 at Screening and at Baseline (prior to study drug application).

Exclusion Criteria:

* Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
* Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
* Previous refractive eye surgery such as photorefractive keratectomy (PRK), laser-assisted sub-epithelial keratectomy (LASEK), or laser-assisted in situ keratomileusis (LASIK).
* Current treatment with monoamine oxidase (MAO) inhibitors.
* Current treatment with barbiturates, opiates, sedatives, systemic anesthetics, or alpha-agonists.
* Less than 3 months stable dose treatment with tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents.
Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine

This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine


Eligibility Criteria:
Inclusion Criteria:

* Male or female, at least 18 years of age.
* Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.

Exclusion Criteria:

* Co-infection with HCV, HDV, or HIV.
* Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
* History of hepatic decompensation
* History of malignancy
* Patient has one or more additional known primary or secondary causes of liver disease
Acute Resistance Exercise and Hydrolyzed Collagen Supplementation

This study aimed to investigate the effect of different doses of hydrolyzed collagen (HC) with resistance exercise (RE) on whole body collagen synthesis in middle-aged males and females.

This study aimed to investigate the effect of different doses of hydrolyzed collagen (HC) with resistance exercise (RE) on whole body collagen synthesis in healthy middle-aged males and females.

Healthy middle-aged males and females ingested 0 grams, 15 grams or 30 grams HC with 50 milligrams vitamin C 1h prior to performing four sets' leg press RE at 10-repetition maximum load, after which they rested for six hours. Blood samples were collected throughout each trial to analyse procollagen type Ⅰ N-terminal propeptide (PⅠNP, a biomarker of collagen synthesis) and β-isomerized C-terminal telopeptide of type I collagen (β-CTX, a biomarker of collagen breakdown) concentration, and the concentration of 18 amino acids that constitute collagen.

This is the first study to investigate the combined effect of different doses HC with high-intensity RE on whole body collagen synthesis in middle-aged men and women. If 30 grams HC intake with RE does augment collagen synthesis more than RE alone, this suggests that long-term HC intake with chronic RE would be beneficial for tendon health, because collagen is the most abundant protein in tendon.

Eligibility Criteria:
Inclusion Criteria:

* At least 12 months experienced in resistance exercise (including weekly lower body exercise)
* Free from musculoskeletal injury

Exclusion Criteria:

* Having a history of patellar tendon pathology
* Vegan
* Consumed nutritional supplements or medication purported to have beneficial effects on muscle-tendon properties (e.g. antioxidants, protein, etc.)
* Had a sustained a lower limb injury in the previous six months
* Smoker/vaper
* Having reached menopause (only for middle-aged female participants)
Survey of Diet and Health Beliefs

The purpose of this research is to better understand people's health and diet knowledge, beliefs, attitudes, and practices. The researchers will use this information to implement better strategies to help Americans maintain more nutritious diets.

The overall goal of this study is to determine whether there are differences in perceptions of healthy nutrition messages depending on from whom the message is coming. More specifically, the researchers aim to examine whether there are differences in how people perceive and intend to follow nutrition information that is coming from a variety of sources.

Eligibility Criteria:
Inclusion Criteria:

* US citizen
* have access to internet
* have an Amazon Mechanical Turk (MTurk) account

Exclusion Criteria:

* under 18 years of age
* no access to internet
Role of Hemostatic Powder (Endo-clotTM) in Success and Prevention of Bleeding Within Gastric Cancer Patients With Bleeding

Gastrointestinal(GI) hemorrhage related with gastric cancer is prevalent in advanced cases mostly. As endoscopic hemostatic methods such as argon plasma ablation (APC) had developed, controlling GI hemorrhage in gastric cancer is much easier these days. but re-bleeding rate is still high, even after successful hemostasis with APC or electrical coagulation. Furthermore patients who were experienced re-bleeding are expected poorer survival outcomes than those who are not. So excellent bleeding control in gastric cancer is most important in GI hemorrhage of gastric cancer.

Recently developed hemostatic powder \[Endo-Clot(TM)\] is easy to use and have proven its usefulness in GI hemorrhage in peptic ulcer diseases. So in this study, investigator will try to find out feasibility \& safety of Endo-Clot(TM) in GI hemorrhage in gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age over 19 and less 80 yeas old
* Gastric cancer was diagnosed with biopsy and/or computed tomography
* Endoscopic hemostasis is needed upto GI hemorrhage
* Endoscopic examination is available in 24hours
* ECOG performance status(PS) \<2

Exclusion Criteria:

* Double primary caner
* Hypersensitivity of hemostatic power\[Endo-Clot(TM)\]
* Variceal bleeding or benign gastric ulcer bleeding
* Hemodynamically unstable with low systolic BP\<90mmHg and/or tachycardia PR\>120bpm
* endoscopic hemostasis within 7 days before screening
* Contraindication for endoscopic examination
* Pregnant
* Breast feeding
* bleeding tendency with low platelet count \<50,000 /mm\^3 and/or INR\>2
* Bacterial infection with needs for antibiotics therapy
* Unavailable to discontinue anti-coagulation agent for 3days
* Vascular shunt
* Cardiovascular and/or pulmonary diseases
* Active hepatitis or severe liver diseases
* Renal dysfunction
* Bone marrow dysfunction
* Neurologic deficit and/or psychotic feature
* Unavailable informed consent
Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery

This randomized clinical trial studies metformin hydrochloride in treating patients with pancreatic cancer that can be removed by surgery. Metformin hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PRIMARY OBJECTIVES:

I. To determine the effect of escalating doses of metformin (metformin hydrochloride) given pre-operatively on pancreatic cancer cell proliferation and apoptosis.

SECONDARY OBJECTIVES:

I. To assess toxicity of escalating doses of metformin given pre-operatively in patients with resectable pancreatic carcinoma.

II. To measure the effect of metformin on the expression of phosphorylated acetyl-CoA carboxylase alpha (ACC), phosphorylated mechanistic target of rapamycin (serine/threonine kinase) (mTOR), and pancreatic cancer stem cells.

OUTLINE: Patients are randomized to 1 of 3 treatment groups.

GROUP I: Patients undergo observation.

GROUP II: Patients receive metformin hydrochloride orally (PO) twice daily (BID) for at least 7 days in the absence of disease progression or unacceptable toxicity.

GROUP III: Patients receive metformin hydrochloride as in Group II.

After completion of study treatment, patients are followed up 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed resectable pancreatic carcinoma; patients with pancreatic neuroendocrine tumors are not eligible
* Patients must be previously untreated with chemotherapy or radiation therapy
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Patients must have surgical resection of the pancreas planned, with enrollment at least 7 days prior to surgery; patients with surgery scheduled \> 15 days will not be excluded
* Hemoglobin (Hg)A1C must be below 7%
* Total bilirubin less than 1.5 X institutional upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 X institutional upper limit of normal
* Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal
* Serum creatinine within normal institutional limits
* Alkaline phosphatase \< 1.5 X institutional upper limit of normal
* Subjects must have the ability to understand and be willing to provide written informed consent

Exclusion Criteria:

* History of metformin use in the previous 3 months
* Treatment with neoadjuvant chemotherapy or radiation therapy
* History of allergic reactions attributed to metformin
* Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Metabolic acidosis, acute or chronic, including ketoacidosis
* Metastatic disease
National Survey of Mental Health After COVID-19 Outbreak

The Serbian national survey - acronym CoV2Soul.RS - has been launched to document mental health (MH) status and understand needs of the population in relation to the prolonged global public health crisis.

This cross-sectional study will collect a representative national sample (18-65 years) by multi-stage probabilistic household sampling method. Trained staff will conduct face-to-face diagnostic interviews (M.I.N.I.). Battery of self-report instruments will be used to measure quality of Life (QoL), level of distress, and associated protective and harmful psychological and societal factors. The investigators aim to assess prevalence rates of MH disorders and associated QoL in the nationally representative sample, to explore how MH conditions and QoL vary with respect to socio-demographic variables, personality, health status and traumatic events during pandemics, and to find how these relationships depend on societal factors characterising municipalities in which they live. Moreover, this study will address perception of pandemic consequences and associated distress in relation to personality and different types of possible mediators. The prevalence rates of MH disorders will be calculated as percentages of participants with a positive diagnosis. The hierarchical structure of the data will be analyzed using Multilevel Random Coefficient Modeling,

CoV2Soul.RS will contribute to an international evidence base about prevalence rates of psychiatric conditions during different phases of the pandemic in different regions and will identify protective and harmful psychological and societal factors for MH and QoL.


Eligibility Criteria:
Inclusion criteria:

* Age between 18 and 65 years
* Speaks Serbian fluently
* Able to give informed consent

Exclusion criteria:

* Cognitive impairment leading to a disability to understand questions
* Severe neurological impairment
* People with impaired hearing and deaf persons