cyrilzakka/clinical-trials huggingface dataset:
Emollient Therapy for Severe Acute Malnutrition

The investigators hypothesize that the absorption of topically applied EFA-containing emollient (SSO) into the skin and thence into the bloodstream in children with SAM will improve skin barrier function and accelerate weight gain and clinical rehabilitation beyond that possible through normal standard-of-care

A child with SAM, in addition to wasting will often present with infection, hypothermia, dehydration and electrolyte imbalance - complications attributable, at least in part, to compromised skin barrier function. Essential fatty acid (EFA)-containing emollients such as sunflower seed oil (SSO) have been shown to augment skin barrier function, reduce transepidermal water loss (TEWL) and risk of bloodstream infection and mortality, and promote weight gain in preterm infants. Recent research from rural Bangladesh showed very low levels of EFAs in young children in the general population. It is believed that EFA levels will be further depleted in children with SAM. So the investigators aim to demonstrate the feasibility of topical applications of SSO to children with SAM, and to measure clinical impact of emollient therapy with SSO on skin barrier function, skin condition, EFA levels in blood, weight gain, co-morbidities (e.g., pneumonia, sepsis), and time to complete acute rehabilitation from SAM, in addition to the benefits of normal standard-of-care.

Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian is willing and able to provide written informed consent for the subject to take part in the trial and comply with an inpatient stay of at least 10 days.
* Children aged 2-24 months inclusive diagnosed with SAM (weight-for-length Z score \<-3 or bilateral pedal edema) admitted in the Dhaka Hospital of icddr,b, Dhaka, Bangladesh
* Willing to suspend usual home skin care treatments for the duration of study

Exclusion Criteria:

* Consent refusal
* Life threatening health conditions such as septic shock and altered consciousness on admission; congenital problems (congenital heart disease or known metabolic disorders, chromosomal abnormalities, renal failure, etc.); any known chronic disease including tuberculosis, HIV infection
* History of drug or other allergy or any condition that may complicate the interpretation of safety or efficacy such as dermatitis which, in the opinion of the investigator, contraindicates participation in the trial, or know hypersensitivity to SSO
* The child is in care (no longer looked after by their parent or legal guardian)
* Participation in another study
Screening for Chromosomal Microarrangements by CGH-array in Developmental Anomalies of the Skin Suggestive of Mosaicism.

The principal result expected is the discovery of inframicroscopic chromosomal rearrangements in regions of the genome not yet known to be involved, or mutations in known candidate genes;

The identification of such a mosaic rearrangement in an affected infant would lead to improved genetic counselling. Indeed, as this mosaicism is a consequence of a genetic event occurring at an early stage of embryogenesis, it would be possible to confirm the sporadic nature of the observed disorder and therefore to predict a very low or even negligible risk of recurrence for the couple concerned. For the affected infant, the risk for his/her own offspring will be assessed according to the nature of the genetic anomaly discovered. For medical practice, investigators hope that this study will lead to a clearer definition of the screening modalities for mosaicism in the disorders concerned. In particular, they hope to determine whether or not it is possible to dispense with a skin biopsy, which is more invasive than a blood sample.


Eligibility Criteria:
Inclusion Criteria:

* Persons who have provided written informed consent
* Lower age limit: infant born at more than 37 WA
* Sporadic disorder
* Patients presenting at least two skin criteria, or one skin criterion and one non-skin criterion
* Skin criteria: 1- extensive epidermal or sebaceous naevus, 2- Extensive "segmental" haemangioma, 3- Flat angioma or extensive complex vascular malformation, 4-Pigmentary disorders with patterns suggesting mosaicism (Blaschko lines)
* Non-skin criteria: Cerebral, ocular, cardiac or genito-urinary malformation, asymmetric body, segmental hypertrophy of a limb, spinal dysraphism (only when associated with haemangioma)

Exclusion Criteria:

* Persons not covered by the national health insurance scheme
* Mendelian disorders: CM-AVM syndrome, glomangiomatosis, Cowden or Bannayan syndrome, type 1 neurofibromatosis, incontinentia pigmenti, CHILD syndrome, Happle-type chondrodysplasia punctata
* Mendelian mosaic disorders: epidermal or epidermolytic, comedo or dyskeratotic nevus.
* Family history of one of these disorders
* Suspicion or an autosomal dominant disease
* Patient and/or parent under guardianship or ward of court
Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease

Coronary heart disease (CHD) is a public health care challenge. There are three types of treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some end-stage CHD patients lost the chance to get those treatment. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients, which is used in tens of countries all over the world. Safety, invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT. There are only three cities in China run the program of CSWT, which are Kunming, Beijing and Shanghai. The investigators designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.

Coronary heart disease (CHD) is a public health care challenge, which lead to 3.5 millions of people died in China every year. There are three types of treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, some end-stage CHD patients with severe cardiac ischemia lost the chance to get those treatment. Their quality of life is influenced by recurrent angina. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients, which is used in tens of countries all over the world. German and Japan are the countries earliest used CSWT. Safety, invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT by objective examination. New small vessels generation on ischemia area was found on mice and pig model. There are only three cities in China run the program of CSWT, that are Kunming, Beijing and Shanghai. Beijing hospital has the only CSWT machine in Beijing. The investigators designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.

Eligibility Criteria:
Inclusion Criteria:

1. Multiple or diffused coronary artery stenosis by coronary angiography and not candidate for PCI or CABG;
2. Myocardial ischemia and/or cardiac dysfunction by objective exams;
3. Angina and/or heart failure could not be control after optimal medication treatment for coronary artery disease;
4. LVEF is above 30%;
5. Signed informed consent

Exclusion Criteria:

1. Acute myocardial infarction;
2. Within one month after PCI or CABG;
3. Heart transplant patient;
4. Mechanic valve implantation patient;
5. Uncontrolled heart failure with LVEF less than 30%;
6. Severe arrhythmia;
7. Pacemaker implantation patient;
8. Infective endocarditis;
9. Severe chronic obstructive pulmonary disease patient;
10. Pregnant or nursing patient;
11. Silicone breast forms patient;
12. Chest tumor patient;
13. Participant in other clinical trials at the same time.
Supplementation of Lycopene in Carotid Atheroma

Stroke is the second leading cause of death worldwide. One of the causes of stroke which can be treated is narrowing of the carotid artery. Currently the only definite treatment option is surgery or endovascular treatment. All patients not qualified for or awaiting surgery are, therefore, left with best medical therapy and with a yearly risk of stroke anywhere between 1% - 35% depending on the severity of the disease.

The study will use the properties of a tomato extract containing lycopene. Previously studies have demonstrated beneficial properties of tomato extracts:

1. It decreases lipid oxidation
2. It decreases DNA damage
3. It has properties that reduce the speed and amount of cell divisions that inflammatory and smooth muscle cells undergo (both of these cell types contribute to atheroma formation).

The investigators wish to assess whether long-term food supplementation with a tomato extract containing lycopene could influence atherosclerotic plaque characteristics. The investigators will assess this using Magnetic Resonance Imaging of the plaque and transcranial Doppler ultrasonography for counting the number of blood clots that go to the brain's arteries. Furthermore the investigators wish to examine the effect of long-term food supplementation with a tomato extract containing lycopene on blood cholesterol levels and lipid oxidation and blood markers of inflammation and injury of the inner lining of the arteries.

This will be a single center, double blind, randomised, placebo controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 - 90 years old,
* Clinically documented carotid symptomatic atherosclerotic disease (symptomatic disease will be considered if one of the following has occurred within 2 months prior to symptoms:

  1. Amaurosis fugax
  2. Transient ischemic attack (TIA)
  3. Stroke (ipsilaterally to the stenotic artery)
* \>30% stenosis on initial B-mode ultrasonography imaging,
* Written, informed consent.

Exclusion Criteria:

* Age \<40 years old or \>90 years old,
* Time from symptom to recruitment \> 2 months
* \<30% stenosis on B-mode ultrasonography imaging,
* Scheduled for surgical/endovascular intervention within 3 months,
* High-dose statin therapy (\>80 mg/day fluvastatin; \>40 mg/day simvastatin; \>40 mg/day pravastatin; \>10 mg/day atorvastatin; \>10 mg/day rosuvastatin 21),
* Other lipid-lowering therapy (fibric acid derivatives, niacin ≥250 mg/day, resins, ezetimibe, fish-oil supplements),
* Chronic use of high dose aspirin \>325 mg/day,
* Allergy or hypersensitivity to tomatoes and tomato products, gadolinium and history of any other significant atopy/allergy (e.g. soy, whey, lutein, lecithin),
* Contraindications for MRI studies including claustrophobia, any MRI non-compatible devices implanted (vascular clips, metal sutures, craniofix, cardiac pacers, endovascular stents/coils, etc.),
* Known renal impairment with creatinine clearance \<50 ml/min (as per departmental policy),
* Women of childbearing potential,
* Inability to consent
INF-α Innate Immune Response to Gliadin

Background \& Aims The enteropathy in Celiac Disease (CD) is due the adaptive and to the innate immune response to gliadin peptides. Gliadin peptide P31-43 activates innate immune response and interferes with vesicular trafficking. Type 1 interferons (INFs) and viral infections play a role in CD pathogenesis. In this paper investigators investigated the role of P31-43 in the activation of the INF-α pathway.

Methods Small intestinal biopsies of CD patients both with active disease on gluten containing diet (GCD) and in remission phase of the disease on a gluten free diet (GFD) and controls were analyzed before and after culture with P31-43. The levels of toll like receptor 7 (TLR7), myeloid differentiation primary response 88 (MyD88), myxovirus resistance protein 1 (MxA) and nuclear factor-κB (NF-κB) proteins and INF-α mRNA was analyzed in intestinal biopsies.

Intestinal biopsies from CD patients and controls were obtained after EGDS performed during routine analysis. The biopsies were immediately immersed in culture medium (Dulbecco's modified medium, DMEM) in a falcon tube and kept for 16h at 37 C before cultivation. Biopsies were cultivated as described in Barone MV1, Caputo I, Ribecco MT, Maglio M, Marzari R, Sblattero D, Troncone R, Auricchio S, Esposito C. Humoral immune response to tissue transglutaminase is related to epithelial cell proliferation in celiac disease. Gastroenterology. 2007,132(4):1245-53.

Eligibility Criteria:
Inclusion Criteria:

biopsy fragments from duodenum were obtained from CD patients with villous atrophy on GCD, controls, affected by gastroesophageal reflux, and CD patients on GFD.

Exclusion Criteria:

other inflammatory intestinal diseases
A Long Term Safety Study of Apricitabine in HIV-infected Patients

This study will examine the long term safety of apricitabine in HIV-1 infected patients from studies AVX-301 or AVX-302. Eligible patients are those who have either (a)completed studies AVX-301 or AVX-302; or (b)met the criteria for virological failure/lack of response, and consequently wish to withdraw early from studies AVX-301 or AVX-302.

The clinical study AVX-301 studies the efficacy and safety of 800mg and 1200mg BID ATC in combination with an optimized background in patients who are HIV-1 infected and have failed treatment with emtricitabine or lamivudine and have confirmed M184V/I mutation. Patients who do not achieve at least a 0.5 log10 copies/mL decrease in plasma HIV RNA by Week 16, or who experience a \>1.0 log10 copies/mL increase (confirmed on two separate occasions at least one week apart) in plasma HIV RNA from nadir at or after Week 16, are eligible for screening for entry into this study. In addition, patients who complete study AVX-301 are also eligible for screening. The clinical study AVX-302 is similar and studies the efficacy and safety of a single dose of ATC (determined in AVX-301). Patients in AVX-302 who experience virologic failure or lack of virologic response will similarly be eligible for screening for entry into this study. In addition, patients who complete study AVX-302 are also eligible for screening. This is a phase 3, open-label, multi-center study of up to 96 weeks duration. Patients will receive for up to 96 weeks open-label ATC, initially at a dose of 1200mg orally BID. Following selection of the optimum ATC dose in protocol AVX-301 and termination of one of the two ATC doses (800mg or 1200mg orally BID) in protocol AVX-301, patients in this protocol will be transferred to the optimum dose, if required. The total number of patients expected to be enrolled in studies AVX-301 and AVX-302 is approximately 1866 in total.Patients will receive ATC orally in combination with their existing ART. Background antiretroviral therapy (ART) may be revised at any time during the study at the discretion of the investigator but must not include lamivudine, emtricitabine, zalcitabine or any other deoxycytidine analogue NRTI. The study will examine the safety and tolerability of long term treatment with apricitabine in combination with other ART.

Eligibility Criteria:
Inclusion Criteria:

* Patients who complete studies AVX-301 or AVX-302 or :Patients who meet the criteria for virologic failure/lack of response in study AVX-301 or AVX-302
* 18 years of age, or older
* Male, or non-pregnant, non-breastfeeding female patients, who agree to comply with the applicable contraceptive requirements of the protocol.

Exclusion Criteria:

* Prior withdrawal from AVX-301 or AVX-302
* Current acute or chronic hepatitis B virus infection
* Current treatment for hepatitis C virus infection
* Renal Function not adequate
Evaluation of 3D Rotational Angiography After EVAR

This is a randomized prospective monocentric study to evaluate the benefits of a 3D rotational acquisition (3DRA) to assess technical success after treatment of infra-renal aneurysm with bifurcated endograft. Patients will be randomized between the standard strategy (2D angiography at the end of the procedure and angioCT-scan before discharge) and the new strategy (3DRA at the end of the procedure). Expected findings are a reduction of radiation exposure and contrast medium used during the hospital stay, with a similar resolution between angioCT-scan and 3DRA to depict the main complications after EVAR (occlusion, kinking, endoleak). Furthermore, any complication depicted after 3DRA group could benefit from an additional procedure during the same operating time, and therefore avoid a second intervention for the patient.


Eligibility Criteria:
Inclusion Criteria:

* Patients treated with EVAR for infra-renal aortic aneurysm
* In a hybrid room
* With a signed consent

Exclusion Criteria:

* Pregnant women
* Patients unable to understand the study protocol or to give their consents
* Renal insufficiency (eGFR\<60mL/min)
* Ruptured aneurysms and other emergency settings
ASSURE WCD Clinical Evaluation - Detection and Safety Study

A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD).

A prospective multicenter single arm open label study to evaluate ambulatory detection performance, arrhythmia detection and safety of the ASSURE™ Wearable Cardioverter Defibrillator (WCD). A total of 130 adult subjects at risk for sudden cardiac arrest but otherwise protected by an Implantable Cardioverter Defibrillator (ICD) will be enrolled at 10 clinical sites in the United States. Subjects will wear the device for approximately 30 days during normal daily activities including sleep. The WCD shock alarms and shock functionality will be disabled. Shock Alarm Event Markers are recorded by the WCD and will be used for analysis of the primary outcome measure. All episodes recorded by the ASSURE WCD and/or the subject's ICD will be reviewed by independent clinical experts.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females, age ≥ 18 years
2. Patients with an active Implantable Cardioverter Defibrillator (ICD)
3. Left Ventricular Ejection Fraction (LVEF) ≤ 40%, measured within the past year (12 months) by echocardiography, nuclear imaging (including MRI), or left ventricular angiography
4. Able and willing to provide written informed consent before undergoing any study-related procedures

Exclusion Criteria:

1. Any condition that by the judgement of the physician investigator precludes the subject's ability to comply with the study requirements, including cognitive and/or physical limitations that would prevent the subject from interacting with the device as intended
2. Any known skin allergy or sensitivity to the study garment materials that will be next to the skin
3. Any breached or compromised skin on the upper body that would be exacerbated by wearing the study garment
4. Work with or are frequently around equipment that produces high electromagnetic fields, for example magnetic resonance imaging devices, power supply facilities, or welding equipment
5. Any planned surgical or medical procedures during the participation period that would require the subject to remove the study device for more than 12 hours
6. Any planned air travel during the participation period
7. Pregnancy
8. Use of mechanical circulatory support, including but not limited to Left Ventricular Assist Device (LVAD) or Total Artificial Heart
9. Implanted Cardiac Resynchronization Therapy Defibrillator (CRT-D)
10. Simultaneous plan/prescription for Holter monitor, mobile cardiac outpatient telemetry (MCOT), Event Recorder, or in-hospital telemetry
11. Use of any electronic medical device that is worn on or near the body requires Sponsor approval, other than continuous positive airway pressure (CPAP), continuous blood glucose monitor, or pulse oximeter oxygen saturation (SpO2) monitor.
12. Under bust chest circumference greater than 52 inches or less than 28 inches
13. Current hospital inpatient
Sit Less Program for Patients With Type 2 Diabetes

This randomized controlled trial aims to evaluate an 8-week intervention designed to reduce sedentary behavior (SB) in patients with type 2 diabetes (T2D) using wearable technology. The intervention involves the use of Fitbit devices to prompt standing/walking breaks, a smart water bottle to encourage hydration-related movement, and tailored text messages for behavior reinforcement. Participants will be assessed at baseline and post-intervention for changes in SB, light physical activity, cardiometabolic markers, and patient-centered outcomes. The study seeks to determine the intervention's acceptability and preliminary efficacy in reducing SB and improving health outcomes in T2D patients.

The investigators propose to develop and conduct a pilot randomized controlled trial to test a wearable technology-based sedentary behavior (SB) reduction intervention in type 2 diabetes (T2D) patients. The study will recruit 80 participants who will be randomized to either the control group or the intervention group. The 8-week intervention aims to reduce daily SB by at least 120 minutes through the use of Fitbit devices, a smart water bottle, and tailored text messages. Participants will set personalized SB reduction goals and receive prompts to stand or walk, along with hydration reminders from the smart water bottle to encourage movement.

Specifically, the study aims to: determine the acceptability of the SB reduction intervention in T2D patients by evaluating satisfaction and compliance; evaluate the preliminary efficacy of the intervention on reducing total SB time and numbers of prolonged SB bouts; and explore preliminary effects on light physical activity, cardiometabolic markers (24-hour glycemic control, BMI, waist circumference, blood pressure), and patient-centered outcomes (confidence in reducing SB, habit strength for SB, and quality of life). Outcomes will be measured at baseline and post-intervention using biometric assessments, questionnaires, and continuous glucose monitoring. The study seeks to provide insights into the feasibility and potential health benefits of a technology-driven SB reduction program for T2D patients.

Eligibility Criteria:
Inclusion Criteria:

* ages 18 and above
* diagnosed with type 2 diabetes
* self-reported HbA1C\<13
* self-report of sitting ≥ 8hr/day
* ability to stand and walk
* ownership of a smartphone.

Exclusion Criteria:

* currently using an activity tracker
* currently participating in exercise or other research programs.
* random blood glucose \> 300 mg/dL.
* non-English speaking.
* patients classified as unstable (e.g., heart failure, uncontrolled arrhythmia) or have kidney disease that limits daily water intake.
* any conditions that prevent standing or walking due to physical or cognitive limitations, such as cognitive impairment, severe pain, problems with lower limbs, or a history of surgeries that limit movement.
* participation in Sit Less Program V1 (IRB #221566).
* currently pregnant.
Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants

This was a randomized, open-label, repeat dose study of once daily relugolix alone or relugolix combined with hormonal add-back therapy (combination estradiol/norethindrone acetate) (E2/NETA) to assess safety, including markers of bone resorption, pharmacokinetics (PK), and pharmacodynamics (PD) endpoints.


Eligibility Criteria:
Inclusion Criteria:

1. Pre-menopausal female between 18 and 48 years of age.
2. E2, P, LH and FSH concentrations within 0.5x of the lower limits of normal range and 2x of the upper limits of normal upper limits of normal range (ULN)
3. Regular menstrual periods for the 3 months prior to study enrollment
4. Body weight ≥ 45 killograms (kgs) and body mass index (BMI) of 20 to 36
5. Capable of giving written informed consent

Exclusion Criteria:

1. Pregnancy
2. Lactating Females
3. Any contraindication to the treatment with E2 and NETA
4. Use of the following medications in the 3 months prior to screening: injectable hormonal contraceptives, sex hormone medications or danazol
5. Use of the following medications in the 6 months prior to screening: injectable gonadotropin-releasing hormone agonists, hormonal, or non-hormonal intrauterine devices
6. History of sensitivity to any of the study medications of components thereof or history of drug
7. Significant gynecological, endocrine, metabolic or other health conditions
8. History of regular alcohol consumption within 6 months of study