cyrilzakka/clinical-trials huggingface dataset:
Study of ARO-ANG3 in Adults With Mixed Dyslipidemia

The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3.


Eligibility Criteria:
Inclusion Criteria:

* Based on medical history, evidence of TG ≥ 150 mg/dL but ≤ 499 mg/dL
* Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy
* Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 17 days apart
* Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care
* Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication
* Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
* Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
* Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
* Able and willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

* Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule
* Active pancreatitis within 12 weeks prior to Day 1
* Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
* Acute coronary syndrome event within 24 weeks of Day 1
* Major surgery within 12 weeks of Day 1 or planned surgery during the study
* Planned coronary intervention (e.g., stent placement or heart bypass) during the study
* Uncontrolled hypertension
* Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
* Uncontrolled hypothyroidism or hyperthyroidism
* Hemorrhagic stroke within 24 weeks of Day 1
* History of bleeding diathesis or coagulopathy
* Current diagnosis of nephrotic syndrome
* Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study
* Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)

Note: additional inclusion/exclusion criteria may apply per protocol
Acute Hyperbaric Oxygen Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in T2D

Diabetes mellitus type 2 (T2D) is characterized by insulin resistance of liver and skeletal muscle, which is at least partly due to impaired muscle mitochondrial function. Long-term HBO therapy, as applied for treating the diabetic foot syndrome, has been shown to improve blood glucose concentrations. To study the underlying mechanisms, we want to examin the short-term effect of HBO treatment on insulin sensitivity and mitochondrial oxidative capacity and production of reactive oxygen species (ROS) in a randomized, double blinded, placebo-controlled cross-over trial.

In total 14 patients are planned. Each participant participates in both experimental parts (100% O2 and ambient air). They are examined immediately after each HBO/ ambient air therapy. The allocation is randomized treated every three weeks with 2-hour therapies using pure O2 or indoor air. Randomized and double-blinded in a cross-over setting, one group of patients with type 2 diabetes is first treated with HBO therapy and the other group is first treated with room air. Here, an ambient pressure of 2.4 ATM is built up and then administered for respiration over a total of 90 minutes of pure O2. Patients are examined on two consecutive days for each part of the study.On the first day serum samples are taken and a sample is taken from the vastus lateralis muscle. A magnetic resonance spectroscopic examination (MRS) is performed on the patient subsequently. In this case, phosphorus metabolites (absolute quantification of ATP, Pi) and the ATP synthase flow rate (fATP) are determined non-invasively by means of 31P MRS and TG storage (HCL) by means of 1H-MRS.

On the next day of the trial patients are treated with HBO therapy or room air. A hyperinsulinemic-euglycemic clamp test (120-300 min) with administration of deuterated glucose (D- \[6,6-2H2\] glucose) (0-120 min) to measure muscular and hepatic insulin resistance will be performed after the end of HBO therapy or room air treatment performed. Indirect calorimetry determines energy consumption and substrate selection (lipid and glucose oxidation) in hyperinsulinaemia. After the end of the HBO therapy or room air treatment and 30 minutes after the start of the clamp test, a sample is taken from the vastus lateralis muscle again.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 75 years
* Type 2 diabetes
* HbA1c ≥ 6 and ≤ 9%
* BMI ≤ 35 kg / m2

Exclusion Criteria:

* Treatment with thiazolidinedione in the last 6 months
* Uncontrolled hyperglycemia (FPG ≥ 240 mg / dl)
* vitamin supplement (washing out at least 4 weeks)
* Patients requiring revascularization
* Serum CRP ≥ 5 mg / dl
* Previous treatment for HBO therapy
* Secondary diabets according to ADA criteria (type 3 B-H, eg pancreopriver diabetes)
* Type 4 diabetes (gestational diabetes), pregnancy
* poor glycemic control (HbA1c\> 9.0%)
* Hyperlipidemia (low density triglycerides and lipoproteins ≥ double upper Reference limit)
Prospective Evaluation of SARS-CoV-2 Antibodies Levels in a Vaccinated Population of Valle de Aburra

Recent research evidence shows that levels of antibodies acquierd post vacunation against SARS-Cov-2 decrease over time as well as the efficacy to control the infection, additionally in a multicenter study carried out in 2020 were evidenced differences in the time it took to decrease the antibodies according to the type of vaccine, defined as mRNA or other types of vaccine.

In this study , the variation of the SARS-Cov-2 antibody levels in patients from Valle de Aburrá will be correlated according to the COVID-19 vaccine received.

After being informed about the study, all patients giving written informed consent will undergo a serial IgM -IgG COVID-19 antibodies blood test and SARS-Cov-2 PCR by nasopharingeal swab, that will be taken at the beginning of the study and mensually for two months.

During the study will be done an active search for SARS-CoV-2 infections in the vaccinated people cohort, and if it is posible to characterize the variant of SARS-CoV-2 in participants previously vaccinated against this pathogen.

The main objective of this study is to describe the pattern of antibodies blood test based in the type of vaccine and correlated the pattern of antibodies SARS-Cov-2 levels in a population of Valle de Aburrá.

Eligibility Criteria:
Inclusion Criteria:

* Adult over 18 years old
* The vaccinated patients to be included must have received a complete vaccination scheme for COVID-19 according to the Ministerio de Salud y Protección Social de Colombia
* SARS-CoV-2 infection in the last 2 months, verified by rtPCR test

Exclusion Criteria:

* Immunocompromised patients
* Immunosuppressive treatments, chemotherapy or antiretroviral therapy
* Outpatient anticoagulant therapy
* For vaccinated people (groups 1 and 2): if have had COVID-19 infection in the last 6 months
A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.

To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program.

56 women newly diagnosed with breast cancer from the Department of Medical Oncology of La Paz University Hospital, Madrid, Spain.

A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures was conducted by physicians of the Nutrition Unit during one year.

Eligibility Criteria:
Inclusion Criteria:

* Years: ≥18
* Sex: Female
* Newly diagnosed breast cáncer

Exclusion Criteria:

* Patients who have disseminated disease.
* Associated eating behavior disorders.
* Patients with dementia, mental illness or decreased cognitive function.
* Consumption of drugs or substances to lose weight (except in those cases in which it is suspended 15 days before starting the study).
* Presence of disease that may interfere with weight loss: severe psychiatric illness, uncontrolled hypothyroidism.
* Pregnant or breastfeeding women.
Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery

Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence \& metastasis, adverse events,etc.

This study adopts a multicenter, open, and registered research method, and plans to include 840 cases, including 360 cases in the Huaier Granule test group, 360 cases in the radiotherapy and chemotherapy control group, and 120 cases in the blank group. Using natural grouping, the registered objects are not pre grouped or queue divided, and the diagnosis, treatment, efficacy, and safety of gastrointestinal malignant tumor patients are accurately recorded under real conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with gastrointestinal cancer (stomach, colon or rectum);
2. Patients who have received gastrointestinal cancer radical surgery within a month;
3. Patients between 18 and 70 years old,no gender restriction;
4. Patients volunteer to participate this study and have signed the informed consent form.

Exclusion Criteria:

1. No chemotherapy or combined radiation and chemotherapy indications；
2. Unable to cooperate to complete related information collection;
3. Participation in any other clinical trial within three months;
4. Conditions that are considered not suitable for this study investigators.
Promoting ColorBRAVE Conversations in Families

The objective of this research is to evaluate a mobile app-based intervention for parents of children in K-2nd grade designed that guides them in how to have productive conversations about race with their children. This study will recruit a national sample of parents and their K-2nd grade children. The impact of the intervention is tested using a wait-list controlled trial design. Outcomes include prosocial behaviors and indicators of emotional well-being.


Eligibility Criteria:
Residence in the US; caregiver age 18 years or older and child age 5-8 years old; ability to read and understand English
Treatment of Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

The purpose of this study is to determine the maximum tolerated dose of the combination of vorinostat, cisplatin, pemetrexed, and radiation therapy in patients with unresectable stage IIIA/IIIB non-small cell lung cancer.

This phase I trial will escalate doses of the histone deacetylase inhibitor (HDAC) vorinostat to a chemoradiation platform for cisplatin, pemetrexed and radiation to a dose of 70Gy in NSCLC patients with unresectable IIIA and dry IIIB disease. The endpoint will be to determine MTD of the combination.

Eligibility Criteria:
Inclusion Criteria:

* biopsy proven non-squamous NSCLC with unresectable stage IIIA or dry IIIB disease.
* FEV1 \>/= 1 liter
* ECOG PS 0 or 1
* Able to swallow and absorb enterally
* Measurable disease per RECIST 1.1
* Adequate organ and marrow function including calculated creatinine clearance \>/= 60 mL/min hepatic enzymes and alk phos \</= 2.5 X ULN.

Exclusion Criteria:

* Chemotherapy or radiotherapy \</= 4 weeks prior to registration (6 weeks for nitrosureas)
* Active bleeding
* Known brain mets
* Prior thoracic radiotherapy that would lead to overlap with current radiation field.
* More than 10% weight loss in 6 months.
* Pancoast tumors, supraclavicular or contralateral hilar lymph node involvement
* Known HIV positive
* Prior treatment with an HDAC inhibitor
Early Surgery Versus Conventional Treatment in Very Severe Aortic Stenosis

The optimal timing of surgical intervention remains controversial in asymptomatic patients with very severe aortic stenosis. The investigators therefore try to compare long-term clinical outcomes of early surgery with those of conventional treatment strategy in a prospective randomized trial.

Management of asymptomatic patients with severe aortic stenosis (AS) remains controversial, and the combined risks of aortic valve surgery and late complications of aortic valve prosthesis need to be balanced against the possibility of preventing sudden death and lowering cardiac mortality. Considering that sudden cardiac death occurs at a rate of approximately 1% per year and that the average postoperative mortality of isolated AV replacement is 3.0-4.0%, the 2007 European Society of Cardiology guidelines do not recommend aortic valve surgery for asymptomatic patients with severe AS and the 2006 American College of Cardiology/American Heart Association guidelines recommend surgery as a class IIb indication only in patients with extremely severe AS and who are at low operative risk. Clinical outcomes vary widely according to the severity of stenosis in asymptomatic AS, and asymptomatic patients with very severe AS are often referred for aortic valve replacement in clinical practice despite the lack of data supporting early surgery. Rosenhek et al recently reported a worse prognosis with a higher event rate and a risk of rapid deterioration in very severe AS, and the investigators also recently reported that compared with the conventional treatment strategy, early surgery in patients with very severe AS is associated with an improved long-term survival in a prospective, observational study. However, there have been no prospective,randomized studies comparing early surgery with a watchful waiting strategy in very severe AS. We sought to compare long-term clinical outcomes of early surgery with those of conventional management based on current guidelines.

Eligibility Criteria:
Inclusion Criteria:

* asymptomatic patients with very severe aortic stenosis who are potential candidates for early surgery. Very severe aortic stenosis are defined as a critical stenosis in the AV area ≤ 0.75 square centimeter fulfilling one of the following criteria; a peak aortic velocity ≥ 4.5 m/sec or a mean transaortic pressure gradient ≥ 50 mmHg on Doppler echocardiography.

According to the revised 2014 AHA/ACC Valvular Heart Disease Guideline that recommends exercise testing to confirm the absence of symptoms in asymptomatic patients with severe AS (Class IIa), eligible patients with a positive exercise test will be excluded from the entry after May, 2014.

Exclusion Criteria:

* Exertional dyspnea
* Angina
* Syncope
* Left ventricular ejection fraction \< 50%
* Significant aortic regurgitation
* Significant mitral valve disease
* Pregnancy
* Age \< 20 years or \> 80 years
* Coexisting malignancies
* Positive exercise test
Impact of ESSURE Devices Withdrawal on the Symptomatology of Patients

The ESSURE device is a method of permanent contraception, marketed in France since 2005. Multiple side effects have been reported by patients since 2015 and the marketing was stopped in 2017. For several months it was observed an increase in requests for withdrawal of these devices. The principal objective of this study is to evaluate clinical improvement and quality of life after ESSURE removal.

This is a multicenter retrospective descriptive study involving the gynecology department of the Croix Rousse Hospital and the gynecology department of the Lyon Sud Hospital over a period of 1 year (1 January 2017-31 December 2017).


Eligibility Criteria:
Inclusion Criteria:

* Women who underwent ESSURE removal due to suspected adverse effects of the device.
* Women who agreed to participate in the study

Exclusion Criteria:

- Women who underwent ESSURE removal to restore their fertility.
Treatment of Intrauterine Growth Restriction With Low Molecular Heparin.

TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN.

TREATMENT OF INTRAUTERINE GROWTH RESTRICTION WITH LOW MOLECULAR WEIGHT HEPARIN: RANDOMIZED CLINICAL TRIAL (TRACIP STUDY).

Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 years.
* Unique gestations
* Diagnosis of early placental intrauterine growth (according to Delphi classification): \<32 weeks at diagnosis + Doppler AU with absent / reverse flow or (estimated fetal weight \<10 percentile + pulsed Doppler ultrasonography) or (estimated fetal weight \<percentile 10 + pulsed uterine artery Doppler).
* Patient giving written informed consent to participate in the study.

Exclusion Criteria:

* Chromosopathies, genetic alterations or fetal malformations.
* Diagnostic treatment with low molecular weight heparins, oral anticoagulants or acetylsalicylic acid prior to inclusion.
* History of heparin-induced thrombocytopenia.
* Active hemorrhage or increased risk of bleeding due to changes in hemostasis.
* Severe hepatic or pancreatic function disorder.
* Organic lesions that may bleed (eg, active peptic ulcer, hemorrhagic stroke, aneurysms, or brain tumors).
Online CBT-I for High Blood Pressure

The purpose of this study is to compare the effect of 6-weekly, 20 minute sessions of 2 online behavioral sleep interventions (cognitive behavioral therapy or healthy sleep habits) on blood pressure, sleep, depressive symptoms and anxiety in people with insomnia and prehypertension or hypertension.

Approximately 30% of US adults have prehypertension (untreated blood pressure ≥120-139/80-89 mmHg) and 29% have hypertension (blood pressure ≥ 140/90 mmHg or antihypertensive medication use). Numerous factors contribute to the development of prehypertension and hypertension including age, genetics, obesity, and behavioral factors such as exercise and diet.However, the sleep disorder insomnia is another behavioral factor increasingly implicated with risk of hypertension. Insomnia, the most frequent sleep complaint in adults, is characterized by difficulty falling asleep, trouble maintaining sleep or non-restorative sleep coupled with significant daytime distress or functional impairment. Insomnia is a pervasive sleep disorder associated with decreased quality of life, reduced work productivity, and increased health care costs; it is increasingly identified as a cardiovascular disease risk factor. Lifestyle modifications recommended for pre-hypertension and hypertension do not address sleep. This pilot randomized clinical trial will test the preliminary efficacy of an online cognitive behavioral therapy intervention (N=40) versus an online healthy sleep habits intervention (N=20), to reduce blood pressure in a sample of untreated individuals with insomnia and prehypertension or hypertension. Participants will be followed for 12-weeks post-intervention. Primary outcome measures are systolic blood pressure. Secondary measures include sleep efficiency, insomnia severity, physical and mental function.

Eligibility Criteria:
Inclusion Criteria:

* prehypertension or hypertension, insomnia (difficulty getting to sleep, staying asleep and/or early morning awakenings), internet access, current email use, willingness to be randomized to either intervention group, ability to read/write in English.

Exclusion Criteria:

* medication known to alter sleep, sleep disorder (other than insomnia), frequent travel over 2-3 time zones, currently receiving behavioral treatment for insomnia, major depression, anxiety disorders, PTSD or bipolar disorder, \>14 alcoholic drinks/week, recreational drug use, prior diagnosis of: epilepsy, dementia/Alzheimer's disease, renal failure requiring dialysis, stroke, secondary hypertension, angina, peripheral artery disease, heart failure, myocardial infarction or cardiac surgery within the past 6 months
Clinical Relevance of Small Airways Disease in Severe Asthma Patients Treated With Anti-InterLeukin-5 Therapy

The aim of this research is to investigate the extent and clinical relevance of small airways disease in severe eosinophilic asthma patients treated with anti-IL5/5R therapy.


Eligibility Criteria:
Inclusion Criteria:

* Severe asthma patients treated with anti-IL5/5R therapy (i.e. mepolizumab, benralizumab, reslizumab) for at least 4 months.

Exclusion Criteria:

* No information about lung function at baseline, or after both 4 months and 12 months.
* No information about clinical response (i.e. number of exacerbations, reduction of mOCS/ maintenance oral corticosteroid dose, ACQ, AQLQ) after both 4 months and 12 months.
* Treatment with another anti-IL5/5R therapy before
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children

The purpose of this study is to identify and characterize the bacteria causing acute otitis media episode in HIV-positive and HIV-negative children (\>=3 months to \<5 years) in South Africa. Middle ear fluid sampling either by tympanocentesis or by careful sampling of spontaneous otorrhoea will be done; nasopharyngeal aspirate and urine sample will also be collected from the subjects.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for all subjects:

* Age: \>= 3 months and \< 5 years at the time of enrolment.
* Signs, symptoms, and conditions:
* One of the functional or general signs of otalgia,, conjunctivitis, fever and either
* Paradise's criteria or
* Spontaneous otorrhoea of less than 24 hours.
* Subject will be included as a treatment failure case.
* Written informed consent obtained from parent or guardian prior to study start.

Inclusion criteria for HIV-positive subjects:

* Documented HIV-positive status as given in subject's medical records. or
* Subjects referred from paediatric HIV clinic.

Inclusion criteria for HIV-negative subjects (including presumed negative children)

* Children who have been tested HIV-negative.
* Children whose mothers volunteer to have tested HIV-negative whilst pregnant with the index case and the child is free to any World Health Organization Grade II stigmata of HIV/acquired immunodeficiency syndrome.
* Children who do not fulfil the World Health Organization staging for HIV infection / immunosuppression.

Exclusion Criteria:

* Hospitalised during the diagnosis of acute otitis media or during treatment.
* Otitis externa or otitis media with effusion.
* Presence of a transtympanic aerator.
* Systemic antibiotic treatment received for a disease other than acute otitis media in the 72 hours prior to enrolment.
* Receiving antimicrobial prophylaxis for recurrent acute otitis media but excluding cotrimoxazole or isoniazid prophylaxis in HIV exposed children.
* Provision of antibiotic by paediatrician/ENT specialist at the enrolment visit prior to the sampling of the middle ear fluid or spontaneous Otorrhoea.
* Children on antibiotics for acute otitis media who are clinically improving.