cyrilzakka/clinical-trials huggingface dataset:
THE RELATIONSHIP OF CRP/ALBUMIN RATIO LEVEL AND PROGNOSIS IN PREGNANT COVID-19 PATIENTS

The CRP/albumin ratio (CAR) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. Recent studies have shown that the CRP/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. With this study it is aimed to investigate the effect of CRP/albumin ratio in predicting the severity and prognosis of the disease in pregnant patients with more severe Covid-19 infection.

Pregnant women are more susceptible to viral infections affecting the respiratory tract than non-pregnant women. Similar to non-pregnant patients, Covid-19 infection occurs with non-specific symptoms in pregnant patients. A computed tomography (CT) scan of lungs and several laboratory parameters are used to predict the prognosis of this infection, which starts with non-specific findings. Although it has been demonstrated that low-dose lung CT can be used safely in pregnant women, both clinicians and pregnant women tend to avoid tomography imaging due to its teratogenic effects

The CRP/albumin ratio (CAR) is a recently defined parameter which represents the ratio of a positive acute phase reactant to a negative acute phase reactant. It is an indicator of both the inflammatory state and the nutritional state, simultaneously. Recent studies have shown that the CRP/albumin ratio is a biomarker with prognostic value for various inflammatory disorders and serious diseases. With this study it is aimed to investigate the effect of CRP/albumin ratio in predicting the severity and prognosis of the disease in pregnant patients with more severe Covid-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Covid PCR test positive patients
* Pregnant

Exclusion Criteria:

* Covid PCR test negative
* Missed data
Activity at Pulse Pressure Above an Individual Threshold in Patients With LVAD

Pilot study in patients with continuous flow left ventricular assist device (cfLVAD) to proof the feasibility of a specific individual training at home aimed to increase pulse pressure above a predefined threshold which might attenuate the loss of arterial wall thickness.

Hypothesis:

Increasing daily physical activity near to normal (\> 10.000 steps per day) with a pre-defined level of pulse pressure (intensity) is a realizable and feasible approach to investigate changes in arterial wall thickness and cardio-respiratory capacity in cfLVAD patients.

The investigators will study 3 cfLVAD patients with low pulse pressure during work package 1 using two different exercises, treadmill and bicycle. Walking and cycling present the most commonly used physical activities which are applicable to most individuals on a daily basis. The investigators aim to demonstrate that individual changes of pulse pressure during these types of exercise can be assessed in cfLVAD patients.

In a feasibility study (work package 2) the investigator will enroll 6 cfLVAD patients to perform home-based physical activity programs including walking a defined number of steps per day with a predefined speed and cycling with a predefined power \[watt\] on a bicycle ergometer. The performance of the patients will be monitored over seven days using a wearable activity device.

Eligibility Criteria:
Inclusion Criteria:

* age 45 to 65
* men
* time since cfLVAD implantation \> 3 months and \< 6 months
* low pulse pressure at rest, (no pulsatility)

Exclusion Criteria:

* musculoskeletal comorbidities restricting exercise
* known diabetes mellitus Type 1 and 2
* acute or chronic infections
* coronary heart disease before cfLVAD implantation
* no pulsatility with increasing exercise
Prediction of Extubation Readiness in Extreme Preterm Infants by the Automated Analysis of CardioRespiratory Behavior

The investigators hypothesize that machine learning methods using a combination of novel, quantitative measures of cardio-respiratory variability can accurately predict the optimal time to extubate extreme preterm infants. In this multicenter prospective study, cardiorespiratory signals will be recorded from 250 extreme preterm infants who are eligible for extubation. Automated signal analysis algorithms will compute a variety of metrics for each infant describing the cardiorespiratory state. Machine learning methods will then be used to find the optimal combination of these statistical measures and clinical features that provide the best overall predictor of extubation readiness. Finally, investigators will develop an Automated system for Prediction of EXtubation (APEX) that will integrate the software for data acquisition, signal analysis, and outcome prediction into a single application suitable for use by medical personnel in the Neonatal Intensive Care Unit (NICU). The performance of APEX will later be clinically validated in 50 additional infants prospectively.

At birth, extreme preterm infants (≤28 weeks) have inconsistent respiratory drive, airway instability, surfactant deficiency and immature lungs that frequently result in respiratory failure. Management of these infants is difficult and most will require endotracheal intubation and mechanical ventilation (ETT-MV) within the first days of life to survive. ETT-MV is an invasive therapy that is associated with adverse clinical outcomes including ventilator-associated pneumonia, impaired neurodevelopment, and increased mortality. Consequently, clinicians try to remove ETT-MV as quickly as possible. However, 25 to 35% of these extubation attempts will fail and infants will require reintubation, an intervention that is also associated with increased morbidity and mortality. Therefore physicians must determine the optimal time for extubation which minimizes the duration of ETT-MV and maximizes the chances of success. A variety of objective measures have been proposed to assist with this decision but none has proven to be useful clinically. Investigators from this group have recently explored the predictive power of indices of autonomic nervous system function based on measurements of heart rate (HRV) and respiratory variability (RV). The use of sophisticated, automated algorithms to analyze those cardiorespiratory signals have shown some promising preliminary results in predicting which infants can be extubated successfully.

Eligibility Criteria:
Inclusion Criteria:

* All infants admitted to the NICU with a birth weight ≤ 1250 grams AND
* Need for endotracheal tube mechanical ventilation

Exclusion Criteria:

* Infants with major congenital anomalies
* Infants with congenital heart disease and cardiac arrhythmias
* Infants receiving vasopressor or sedative drugs at the time of extubation
* Infants extubated directly from high frequency ventilation
* Infants extubated to room air, oxyhood or low-flow nasal cannula
Safety and Efficacy of Combination Saxagliptin & Dapagliflozin Added to Metformin to Treat Subjects With Type 2 Diabetes

The purpose of this study is to learn if a combination of BMS-477118 (Saxagliptin) and BMS -512148 (Dapagliflozin) added to Metformin can improve (decrease) Glycosylated Hemoglobin (Hemoglobin A1c) in patients with type 2 diabetes after 24 weeks of treatment. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 2 diabetes mellitus (T2DM) with HbA1c ≥ 8.0% and ≤ 12.0%
* Stable metformin therapy dose of ≥ 1500mg for at least 8 weeks prior to screening
* Body mass index (BMI) ≤ 45.0kg/m2

Exclusion Criteria:

* Estimated glomerular filtration rate (eGFR) \< 60mL/min/1,73m2 and Serum Creatinine (Scr) ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females
* Uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 160mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100mmHg
* Hepatic disease
* Cardiovascular disease within 3 months
Insulin Detemir Action in Cerebro

The aim of this study is to test the hypothesis that subcutaneous administration of insulin detemir, as compared to insulin NPH, leads to a more pronounced effect on cerebral glucose metabolism and/or cerebral blood flow in brain regions associated with appetite regulation, to account for the reported difference in weight.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetic patients;
* Diabetes duration =/\> 1 year;
* HbA1c \~ 7,5%;

Exclusion Criteria:

* Recent onset of DM;
* BMI \< 18 OR \> 35 kg/m2;
* T2DM;
* History of major heart/renal disease;
* Severe untreated proliferative retinopathy;
* History of recurrent severe hypoglycaemia;
* (History of) brain disorders;
* Alcohol abuse,(History of) drug abuse, benzodiazepines, selective beta-blockers, oral steroids, oral anticoagulants;
* Current psychiatric disease/treatment;
* (history of) eating disorders;
* History of severe head trauma accompanied by loss of consciousness;
* Any endocrine disease not well controlled for at least 3 months;
* Inability to undergo MRI;
* Visual acuity \< 0.3;
* Known or suspected allergy to trial product or related products
Longitudinal Study for Central Nervous System Vasculitis

Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. The purpose of this study is to establish a research cohort to investigate the disease process, treatments, and patient outcomes in CNSV.

Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. Originally described in the early 1950s, research in the disease has been slow to progress, largely limited by the rarity of the disease and the lack of biologic materials for basic and translational investigations. To date, the bulk of research in the field has been clinical, largely consisting of retrospective case series, predominately from single sites, focusing on correlations among clinical, imaging, and histopathology data. Collectively these series suggest the existence of clinically-relevant subsets. Such studies, while enhancing our knowledge of this rare disease, are limited by small numbers of patients (especially those confirmed by histopathology), and the near absence of detailed investigations into the biomolecular and immunopathogenic basis of the disease.

Development of this longitudinal cohort and multicenter approach offers the potential to generate new insights, generate new questions, and further our understanding of its natural history, pathophysiology, genetic basis, and discovery of biomarkers to assess disease activity and prognosis.

Study visits will occur every 3 months for this first year, and then annually for two more years. Blood collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.

Eligibility Criteria:
Inclusion Criteria:

i. Diagnostic criteria for CNSV

1. The presence of an acquired and otherwise unexplained neurologic deficit
2. The presence of either classic angiographic or histopathologic features of angiitis in the CNS
3. No evidence of systemic vasculitis or any condition that could cause the angiographic or pathologic features

ii. ≥18 years of age

Exclusion Criteria:

i. Unwilling to sign informed consent.
Chloroquine Phosphate Against Infection by the Novel Coronavirus SARS-CoV-2 (COVID-19): The HOPE Open-Label, Non Randomized Clinical Trial

This is an open label clinical study to evaluate the activity of chloroquine phosphate in patients with SARS-CoV-2 virus infection. The study aims to document possible prevention of pneumonia in patients staying at home and in improving the symptoms of SARS-CoV-2 pneumonia in patients who will be hospitalised.

Humanity has been experiencing a new pandemic of the SARS Coronavirus-19 virus (SARS-CoV-2) since December 2019, causing the disease known as COVID-19. As of March 23, 2020, there have been 382,341 documented episodes of infection worldwide, of which 16,567 have died. An important limitation in the treatment of the disease is the absence of drugs with known antiviral activity against SARS-CoV-2. Recent data suggest that chloroquine has sufficient in vitro activity against the SARS-CoV-2 virus by inhibiting virus entry into cells. It has recently been described that hydroxychloroquine significantly reduces the percentage of patients who have positive sputum in the SARS-CoV-2 virus within 6 days. However, the clinical efficacy of the drug has not been described and it has significant side effects, including more than 10% anorexia, headache, blurred vision, diarrhea or vomiting, and myocardiotoxicity. The frequency of adverse effects of chloroquine in combination with the well-known in vitro activity of chloroquine have led to the design of clinical trials around the world to document the benefits of its use. The present study will evaluate the activity of chloroquine phosphate in patients with SARS-CoV-2 virus infection.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Both genders
* For women of childbearing age, they should use or be willing to use a double contraceptive method during the study. A urine pregnancy test to exclude pregnancy will be performed prior to study initiation.
* Written consent after information provided by the patient or the legal representative in the event that the patient cannot consent.
* Upper respiratory or lower respiratory tract infection, as in Annexes II and III respectively.
* Positive respiratory secretion test for SARS-CoV-2 virus by molecular techniques or positive blood IgM titers.

Exclusion Criteria:

* Under 18 years of age
* Denial of written consent
* Any patient case where it has been decided not to rejuvenate
* Serum AST values greater than 5 times the upper normal range
* QTc interval in rest electrocardiogram greater than 500msecs
* Pregnancy or lactation. Urgent pregnancy test to exclude pregnancy before inclusion in the study
Group Therapy Program for Women With Physical Disabilities

More women with disabilities (30%) report "feelings such as sadness, unhappiness, or depression that prevent them from being active" compared to women without disabilities (8%). The contexts of the lives of WPD, which often include high rates of poverty, architectural and attitudinal barriers, and higher vulnerability to violence and abuse, contribute to this mental health disparity. To help address this disparity, the overall goals of this pilot study are to: 1)1. Develop a cognitive behavioral group therapy intervention to address the specific needs of WPD who experience depressive symptoms; and 2. Pilot-test the intervention to preliminarily evaluate its efficacy using a mixed-methods approach. The proposed and revised study outcomes were derived from our previous work with WPD as well as from feedback obtained from community meetings conducted since our last submission of this proposal. A pilot of the modified intervention with a total of 90 participants will be conducted using a using a wait list control design. The decision to use a wait list control design was made jointly with our community partners to ensure that all WPD participating in the study have access to the intervention.

The project will use a longitudinal mixed method research design. Phase I will utilize focus groups conducted with WPD to support development of the group therapy program. Phase II will evaluate the efficacy of the intervention using a randomized design. Measures to protect human subjects include development of detailed safety and referral protocols including 24 hour access to emergency mental health assessment and intervention as needed.

Eligibility Criteria:
Inclusion Criteria:

* Women with physical disabilities age 18 and older who require some form of accommodation and experience significant depressive symptoms as defined by a cut off score of 16 or greater on the CES-D.

Exclusion Criteria:

* Women currently receiving other psychotherapy treatment
* Women who are psychotic or have significant cognitive impairment
* Women who are actively suicidal with intent and plan
* Women who have discontinued or initiated antidepressant medications within an 4 week time period.
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)

The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).

The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PN ≥ 3 months before screening.
* ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area \<20% BSA.
* IGA-CPG-S score of ≥ 2 at screening and baseline.
* Baseline PN-related WI-NRS score ≥ 7.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Chronic pruritus due to a condition other than PN
* Total estimated BSA treatment area (excluding the scalp) \> 20%.
* Neuropathic and psychogenic pruritus
* Active atopic dermatitis lesions within 3 months of screening and baseline.
* Uncontrolled thyroid function
* Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results.
* Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching.
* Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline
* Pregnant or lactating, or considering pregnancy.
* History of alcoholism or drug addiction within 1 year
* Known allergy or reaction to any of the components of the study drug.
* Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities.
* Employees of the sponsor or investigator or otherwise dependents of them.
* The following participants are excluded in France:

  1. Vulnerable populations according to article L.1121-6 of the French Public Health Code.
  2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code.
  3. Individuals not affiliated with the social security system.
Stress Hormones and Human Cocaine Use - 7

The purpose of this study is to determine the HPA axis and adrenergic system activation in response to cocaine administration.

The goal of this study was to investigate the role of sympathetic-adrenal medullary (SAM) and hy0pothalamo-pituitary-adrenal (HPA) systems in mediating the addictive effects of cocaine. A toal of 6 male subjects were enrolled for this 5 day inpatient study. Subjects were assigned to either cocaine (32mg /70kg iv) or placebo (saline iv) treatment during the first experimental sessions and were crossed over to the alternative treatment during the second experimental session. Endpoints that were followed during the experimental sessions included neuroendocrine (serum epinephrine, norepinephrine and cortisol levels), physological (heart rate/blood pressure, EKG) and subjective measures (Beck Depression Inventory, Craving Questionnaire). We hypothesized that cocaine administration would lead to increased blood levels of norpinephrine, epinephrine and cortisol in cocaine dependent subjects.

Eligibility Criteria:
Inclusion Criteria:

Males between the ages of 20-45. History of smoked or intravenous cocaine use on the average of at least once a week over a 6 month period. Current history of good health and normal EKG.

Exclusion Criteria:

History of suicide attempt, bipolar disorder, schizophrenia, or generalized anxiety disorder. Current problem with major depressive disorder. Current use of alcohol or other drugs on a daily basis. History of major medical illnesses. Currently on parole, probation or a legal history of violence. Treatment for chemical dependency within the past 6 months. History of sensitivity to tricyclic compounds or other prescription drugs. Use of any psychotropic drugs including MAOIs in the past 6 months.
Clinical Trial to Demonstrate the Efficacy of a Dietary Supplement in Decreasing Cardiovascular Risk

This clinical trial seeks to verify the efficacy of a red rice yeast dietary supplement in the decrease of cardiovascular risk, by assessing variables related with cardiovascular risk as levels of cholesterol, triglycerides and transaminases among other, in two groups of participants that will be taking either the dietary supplement or a placebo during a six months period.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Body Mass Index (BMI) between 18.5 y 29.9.
* LDL-c levels between 100mg/dL and 160mg/dL
* 10 year estimated cardiovascular risk assessed by the ASCVD less than 20%
* Accepts to participate and sings Informed Consent.

Exclusion Criteria:

* Patients with history of cardiovascular diseases.
* Patients with secondary hyperlipidemia caused by diabetes mellitus, or kidney, liver or thyroid diseases.
* Patients with muscle diseases
* Patients undergoing pharmacological treatment with any of the following: lipid lowering agents, antifungal, macrolides, or hormone replacement therapy in progress or during the last 2 months.
* Patients with proven intolerance with the components present in the dietary supplement.
* Patients with any other concomitant disease that to the researcher's criteria are not susceptible to participate in the study.
* Woman that are pregnant, in breastfeeding period or with a possibility of starting a pregnancy.