cyrilzakka/clinical-trials huggingface dataset:
Effects of Dairy- and Berry-based Snacks on Postprandial Glucose Metabolism in Older People

Malnutrition or its risk is common among older people. To maintain adequate nutrition, increased meal frequency is important. In addition to main meals, regular consumption of nutrient- and energy-dense snacks is recommended. The study examines the post-meal responses to dairy- and berry-based snacks tailored for older people. The plasma concentrations of glucose, insulin and free fatty acids are measured during three hours after snack consumption. In addition, subjective satiety responses and heart rate variability are recorded.


Eligibility Criteria:
Inclusion Criteria:

* Home-dwelling

Exclusion Criteria:

* Smoking
* Type 1 diabetes
* Type 2 diabetes treated with oral medications or insulin
* Cognitive impairment
* Antibiotic medication within the past 3 months
* Blood donation within the past month
Context-Aware Mobile Intervention for Social Recovery in Serious Mental Illness

This open trial will test a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social engagement in consumers with serious mental illness.

Social isolation is common in serious mental illness and has a profound negative impact on recovery. This study evaluates a new technology-supported blended intervention, mobile Social Interaction Therapy by Exposure (mSITE), that targets social behavior, and it also validates several new techniques for measuring social behavior. mSITE blends brief in-person psychotherapy with context-triggered mobile smartphone intervention and remote telephone coaching. The investigators will conduct an open trial of mSITE, evaluating whether the intervention leads to clinically significant changes in the frequency of social interactions. The investigators will also determine the dose of app plus remote coaching necessary to achieve this effect, by evaluating change at 12, 18, or 24 weeks. If found to be effective, a scalable intervention that reduces social isolation in serious mental illness would have significant personal, societal, and economic impact.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary informed consent to participate and capacity to consent;
2. Age 18 to 65;
3. DSM-5 diagnosis of schizophrenia, schizoaffective, bipolar I disorder or major depression with history of psychosis based on a SCID-5 interview and available medical record review;
4. Minimum level of social avoidance defined by a score of ≥ 2 on the Scale for the Assessment of Negative Symptoms (SANS) asociality item;
5. ≥ 6th grade reading level on the Wide Range Achievement Test-4 Reading subtest (to read therapy workbook).

Exclusion Criteria:

1. Prior CBT in the past 2 years;
2. Greater than moderate disorganization on the PANSS (P2- Disorganization item \>5);
3. DSM-5 alcohol or substance dependence in past 3 months based on the SCID;
4. Level of care required interferes with outpatient therapy (e.g., hospitalized; severe medical illness)
5. Unable to adequately see or manually manipulate a phone;
6. Resident of an integrated housing facility that also provides treatment services.
Safety and Efficacy of the Use of Botox on Acne

• To determine the safety and efficacy of Botox Treatment in subjects with mild to moderate acne vulgaris defined by the Investigator's Global Assessment (IGA)

• 90 day trial, with botox being injected at baseline/screening visit. Photos will be taken throughout the study and patients will be evaluated by masked injector evaluator and a masked evaluator. Patient will complete a subject evaluation at each visit. Follow-up visits occur at Day 3, 7, 14, 30 and 90.

Eligibility Criteria:
Inclusion Criteria:

* Between the age of 18 and 50 years of age
* Not pregnant and negative pregnancy test, not planning on getting pregnant
* Mild to moderate bilateral acne lesions on the face
* Able to understand the requirements of the study and sign an Informed Consent Form
* Have the time and ability to complete the study and comply with instructions(i.e will be around for the duration of the study)
* Skin types I, II, III, IV and V

Exclusion Criteria:

* Subject has skin type VI
* Subject has a significant concurrent illness, such as diabetes, epilepsy, lupus or congestive heart disease
* Concurrent skin conditions affecting area to be treated
* Prior exposure to any serotype of botulinum toxin for any purpose in the 3 months immediately prior to study enrollment
* Prior surgery on the area to be treated within 3 months of initial treatment or during this clinical evaluation
* Open laceration, abrasion active cold sores or herpes sores, multiple dysplastic nevi in areas to be treated?
* Permanent or semi-permanent dermal filler treatment within the last 6 months
* Medium or deep depth chemical peel resurfacing procedure within 3 months of treatment or during this clinical evaluation
* Has used oral isotretinoin (Accutane) within 6 months, or use of topical isotretinoin within 3 months, of initial treatment or during this clinical evaluation
* Prior light /laser treatments at target locations within 3 months of enrollment or during the course of this clinical evaluation
* Any physical or mental condition which, in the investigator's opinion would make it unsafe for the subject to participate in the clinical evaluation
* Use of oral antibiotics for acne and/or medication that cause photosensitivity within 2 weeks of initial treatment
* Participation in a study of another investigational devices or drugs within 3 months of enrollment
* Subject shows symptoms of a hormonal disorder
* Subject cannot be treated for (past or present) any form of treatment of active cancer or having a history of skin cancer or any other cancer in the area to be treated
* Subject is currently using immunosuppressive medications
Electrolytes Disturbances in Critically Ill Egyptian Patients

All selected individuals will be subjected to the following:

1. Full medical history taking
2. Full clinical examination, APACHE II score on admission
3. Electrolytes panel daily on ICU admission
4. Estimate the duration of stay at ICU Also all selected individuals will be sectioned into groups regarding sites of collection (surgical ICU, CCU and medical ICU). All collected individuals will be sectioned regarding electrolytes imbalance into mild, moderate and severe groups

Study Procedures: All selected individuals will be suffering from electrolyte imbalance (EI) with the following data will be obtained:

o Measurements:

1. Demographic data: age - gender - BMI - electrolytes data on ICU admission
2. Vital data: heart rate - respiratory rate - blood pressure measurement - Oxygen saturation - Urinary output - Temp +/- CVP measurement.
3. Lab.: "CBC - Kidney function tests - liver function tests - ABG - levels of serum sodium, potassium, magnesium, phosphorus, ionized calcium and chloride", with maximum 5 mm blood sampling per day. Serum-sodium levels will be corrected for serum-glucose by lowering the sodium concentration by 2.4 mmol/L for every 100 mg/dl increase in glucose. Corrected Sodium = Measured sodium + 0.016 (Serum glucose - 100) A correction formula was also used to calculate albumin-corrected calcium levels (mmol/L) Corrected Calcium = (0.8 (Normal Albumin - Pt's Albumin)) + Serum Ca
4. APACHE II score
5. Comorbidities
6. Complications: AKI- Acute myocardial infarction
7. Duration of ICU stay
8. Duration of hospital stay
9. Outcome (regarding eventual complications: AKI- Acute myocardial infarction)

Eligibility Criteria:
Inclusion Criteria:

- All patients admitted to medical ICU, surgical ICU and CCU suffering from electrolyte imbalance (EI) over 18 years with the comorbid conditions :

1. Hypertension
2. Heart failure
3. Chronic chest diseases
4. Cancers
5. Chronic kidney disease
6. Diabetes mellitus
7. Cardiac dysrhythmias
8. Pneumonia
9. Sepsis
10. Dehydration
11. Critical bones fractures

Exclusion Criteria:

* Patients with

  1. Age less than 18 year old
  2. Patient or his 1st degree relatives refuse to participate
  3. Patients without electrolytes data
  4. Current smoking
Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome

This prospective single-centre randomized control trial aims at evaluating the safety and efficacy of hemoadsorption with CytoSorb® in 40 patients with Post-Cardiac Arrest Syndrome admitted to the ICU.

Patients presenting Post-Cardiac Arrest Syndrome (PCAS) in the 24 hours following their admission in Intensive Care Unit will be randomly assigned either to a control group (standard of care) either to a "Hemoadsorption" group. In the latter, the patient will be connected in the 6 hours following randomization to an extracorporeal circuit, in which a Cytosorb ® cartridge will be placed. The circuit will be set up in hemoperfusion mode. The therapy will take place for a minimum of 12 hours and a maximum of 24 hours. Anticoagulation will be achieved using a regional heparin-protamin regimen.

Blood samples will be collected at randomization, T1 (6 hours post-randomization), T2 (12 hours after randomization), T3 (24 hours after randomization), T4 (48 hours after randomization) and T5 (48 hours after randomization), to assess change in inflammatory cytokine levels.

Eligibility Criteria:
Adult (≥18 years old) patients admitted to the ICU after CA, at risk of PACS as defined by the presence of at least one of the following characteristics (at any time within 24hrs of CA):

* Need for a vasoconstrictor (norepinephrine dose \> 0.2 µg/kg/min to maintain MAP \> 60-70 mmHg, , or equivalent vasoconstrictor agent) for at least one hour
* Serum lactate level \> 6 mmol/l
* Time to ROSC \> 25 minutes

Exclusion Criteria:

* Evidence for patient's refusal to participate in clinical trials
* Non commitment for ongoing medical therapy (imminent withdrawal of care)
* Cardiac arrest caused by hemorrhagic shock
* Contraindications to therapeutic heparinization
* Shock of primary cardiac origin (LVEF \<20%)
* Platelet count \<20 G/L
* Deep immunosuppression state, as defined by neutrophils \<1 G/L or CD4 \<200 /mm3
* Pregnancy
* Acute sickle cell crisis
* Refractory cardiac arrest with ECMO implantation
* Need for renal replacement therapy at time of randomization
* Concomitant enrolment in another study
* Non availability of the research team at time of eligibility at time of randomization
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19

Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known.

The investigators will explore patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected.

The investigators will determine whether this persistance varies according to

* the severity of the Covid-19
* a treatment by steroids during the covid-19. This will help to anticipate whether a second wave of infection is possible in a non-naive population.

Covid-19 is associated with the onset of anti-SARS-CoV-2 antibodies; in a majority of patients, neutralizing antibodies are detected. However, the long-term persistence of such protective antibodies is not known.

The investigators will explore adult patients with a proven Covid-19 (positive PCR) 6 and 12 months after the diagnosis to determine whether neutralizing antibodies are still detected.

The investigators will determine whether this persistance varies according to

* the severity of the Covid-19 (3 groups: no oxyegn therapy; oxygen therapy of less than 3L/min; oxygen therapy of 3L/min or more)
* a treatment by steroids during the covid-19. Immunocompromised patients will be excluded.

Eligibility Criteria:
Inclusion Criteria:

* positive SARS-CoV-2

Exclusion Criteria:

* age under 18
* immunocompromised at the onset of Covid-19
Serum Free Fatty Acid Metabolite Biomarkers of Lung Cancer

This study aims to evaluate the performance of serum free fatty acids as biomarkers for the identification of lung cancer.

We will compare the concentration of free fatty acids and their metabolites between patients with lung cancer and control pulmonary patients without known cancer. The diagnostic accuracy will be assessed for potential predictors.

Eligibility Criteria:
Inclusion Criteria:

* Age from 40 to 80
* Lung adenocarcinoma with pathological diagnosis
* Lung squamous cell carcinoma with pathological diagnosis
* Control patients should have at least one of the following criteria: (1) current or ex-smoker with at least a 10 pack-year history, (2) a first-degree relative with a history of lung cancer, or (3) a clinical diagnosis of COPD.

Exclusion Criteria:

- Lung cancer patient without serum sample before the initiation of treatment
Dysautonomic Phenotype in Male Patients With MECP2 Mutation

Dysautonomic signs are well known among girls with a Rett Syndrom. Rett syndrom is caused by a MECP2 mutation in 95% of cases. We want to search dysautonomic signs among boys with a MECP2 mutations because they are less studied than the girls and they have more varied phenotypes.

First, we will launch a national call for participation in all the genetics departments in France to research boys with a missense or a non-sens mutation in the MECP2 gene. Our inclusion criteria is : less than 16 years old or dead before 16 years old patients of masculin sex with a missense or non-sens mutation in the MECP2 gene. Exclusion criteria is : patient under judicial protection or participation refusal by one of the legal guardian. Inclusion will take place in August 2020.

We had conceived an excel spreadsheet (2007 version) to collect all the datas needed with general data such as age, genetic mutation with the HGVS nomenclature using the NM_001110792.2, familial and personal history, mensurations, dysmorphic signs. To search dysautonomic signs, we used a system approach. We will look for neurological signs : abnormal movements, sleep disturbance, cardiologic signs :abnormal bradycardia or tachycardia, hypotension, rythms anomalies, respiratory signs : respiratory irregularities, apnea, hyperpnea , digestive signs : gastrooesophagal reflux, constipation, diarrhea, vomiting or subocclusif episodes, thermoregulation signs : abnormal hypo or hyperthermia, excessive sweating. Each time a dysautonomic sign will be reported in a letter of a patient, we will demand this sign to be objectived by a complementary exam, or by a precise device during an hospitalisation : electoencephalogram (EEG), polysomnography (PSG), Electrocardiogram (ECG), holter-ECG, digestive fibroscopies, scoped surveillance.

If we have a positive response, we will contact the main caregiver of the patient who can be a neurologist or a geneticist and will provid him a spreadsheet and an explanatory sheet. We will ask of him a systematic review of all the letters of the patient including letters of hospitalisation, of the specialists, complementary exams. A non-opposition letter will be sent to him in a way he can send it to the legal guardians of the children : a non-opposition of 15 days will be requested. Then, the filled spreadsheet will be sent back to the center of inclusion in Brest through a securised mailbox. Data will be kept on a secure database with a password.

Our primary endpoint is the presence of at least one dysautonomic sign. We intend to include between 10 and 20 patients in this multicentric study. To analyse our results, we will use a descriptive approach.

This protocole was validated by the Ethic Comitee of Brest in june 18, 2020

Eligibility Criteria:
Inclusion Criteria:less than 16 years old or dead before 16 years old patients of masculin sex with a missense or non-sens mutation in the MECP2 gene -

Exclusion Criteria:patient under judicial protection or participation refusal by one of the legal guardian

-
Longterm Safety Study of BEMA Buprenorphine in Subjects With Chronic Pain

The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.

This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic pain.

BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant and non-nursing female aged 18 or older
* History of moderate to severe chronic pain:

  1. Subjects completing study BUP-301 (low back pain) or
  2. Osteoarthritis or neuropathic pain, or subjects not completing study BUP-301 (low back pain), pain for ≥3 months with a pain intensity ≥5 \[11 point NRS\] reported at the titration period Day 0/1 visit following a washout period (opioids, NSAIDs, and muscle relaxants) of approximately 12 to 24 hours AND currently taking ≤60 mg oral morphine equivalent/day (including opioid-naïve) for 1 week or longer
* Stable health, as determined by the Investigator, on the basis of medical history, physical examination, and laboratory results so as to comply with all study procedures
* Female subjects of childbearing potential must be using a recognized effective method of birth control
* Written informed consent obtained prior to any procedure being performed

Exclusion Criteria:

* Cancer related pain
* Reflex sympathetic dystrophy or causalgia (complex regional pain syndrome), acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis
* Surgical procedure for pain within 2 months, or nerve/plexus block within 4 weeks, prior to titration period Day 0/1 visit
* History of severe emesis with opioids
* Clinically significant sleep apnea in the judgment of the investigator
Surgery in the Time of COVID-19 Pandemic

The ongoing coronavirus disease 2019 (COVID-19) which started in China, was declared on the 11th of March as a global pandemic 2020 by the World Health Organization (WHO).

Governments around the world have introduced differing forms of lock downs since the start of the pandemic demanding citizens to confine to their homes and go out only in necessity to minimize exposure to the virus. The response was observed in the emergency departments and the number of patients who presented for non-Covid issues drastically reduced.

Hospitals activated their mass casualty management plans and have reorganized and overstretched their capacity to be able to absorb both the influx of patients with the virus and those with other conditions.

Part of that reorganization was reducing the surgical activity. The main focus was shifted to patients who are considered urgent and elective surgery were postponed. Hence only surgical emergencies were maintained. Many did not present to the emergency department for fear to contract the virus and from a sense of national and global solidarity against that pandemic.

Whereas these measures are essential to prevent the spread of the virus, it may be hypothesized that for non-Covid issues, including surgical emergencies, patients may present late to the emergency department due to fear of contracting the infection in hospital. This would delay their management and lead to a worsened symptomology on presentation requiring a more complex surgical intervention with an increased complication profile.

The investigators present initial data from four major hospitals in Belgium, characterizing surgical emergencies that were managed since the start of the pandemic and discuss the repercussion the pandemic has on management of urgent surgical patients and most likely evolution of surgery after the pandemic.


Eligibility Criteria:
Inclusion Criteria:

Patients who had a surgical procedure since the start of the lock down in Belgium due to the COVID19 pandemic (16 of March 2020 to the 12 of April 2020).

Exclusion Criteria:

None
The Effect of an Azygos Vein Coil on Defibrillation Threshold

When implantable cardiac defibrillators are implanted (ICDs), the defibrillation threshold (DFT), of the amount of energy required to effectively terminate life-threatening arrhythmias is determined. The device is then programmed to discharge a larger amount of energy in order to provide a safety margin. In some patients, the DFT is so high, that an adequate safety margin is not programmable. Placement of a defibrillation lead in the azygos vein has been found to be helpful in these patients. This goal of this trial is to attempt to quantify the average reduction in the DFT (if any) that results from the addition of the azygos lead.

Patients undergoing placement of an ICD for the primary or secondary prevention of sudden cardiac death will be asked to participate. Patients will undergo implantation of a standard right ventricular ICD lead at the time of ICD implantation. In addition, patient will receive another high voltage ICD lead placed in the azygos vein as has been previously described in the literature (1). After sedating the patient, the DFT will be determined using a binary search algorithm. This consists of testing the device at a given output for the first shock after inducing ventricular fibrillation (VF). Should the shock fail, external defibrillation will be attempted, as is the standard method for performing DFT testing. As per the standard method of DFT testing, VF will be induced a second time, with the shock strength dependent on the success of the first shock. If the first shock was unsuccessful, the second will be at a higher output. If the first shock was successful, the second will be at a lower output. A third shock will then be delivered, based on the success or failure of the preceding shock to define the DFT. Of note, as the device can be programmed to give multiple shocks for one episode, VF will not necessarily need to be induced each time. For example, VF could be induced, and the device programmed to give a 20 Joule (J) shock followed by a 23J shock if not successful, thus limiting the number of VF inductions required. DFT testing will be done using both the standard configuration of high voltage leads as well as using the azygos lead. We hypothesize that using the azygos lead will result in a lower DFT.

Eligibility Criteria:
Inclusion Criteria:

* Any patient undergoing elective placement of an ICD for the primary or secondary prevention of sudden cardiac death is eligible. Exclusion criteria include any contraindication to endovascular ICD implantation which includes but is not limited to; active infection, occluded venous access, or inability to perform DFT testing secondary to the inability to sedate the patient or hemodynamic compromise.

Exclusion Criteria:

* Any contraindication to ICD or the inability to place an azygos vein coil.
Effect of Modified Playground Environment on Health, Particularly Immune System

Children were exposed to biodiverse material or non-diverse material in sand pits. The two arms were compared. Immune response and bacterial markers were followed.

Children of age 3-5 were randomly divided into two groups (arms). One received guidance and biodiverse material for 20 minutes each day for two weeks. The other received the a similar material and guidance but the microbial community in the material was poor in diversity. Bacterial community changes and immune system markers were analyzed and compared between the two arms. Potential changes in Interleukin 10 was the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* born in Finland
* spends daily (5 d a week) several hours in one of the daycares in which the trial was performed

Exclusion Criteria:

* medication affecting immune system function
* medication affecting microbiota
* cancer
* immune deficiency
* living on a farm
* not born in Finland