cyrilzakka/clinical-trials huggingface dataset:
Predictive Factors of PTSD in Adults Admitted to an Emergency Service

After trauma or stress factor like death exposition, serious injuries or sexual violence, some patients may develop stress reaction characterized by the presence of various symptoms among different categories (reviviscence, negative humor, dissociates symptoms, occasion, hypervigilance). In the month following trauma, the investigators speak of acute stress reaction (ASR) when symptoms are present during at least three days. If symptoms are present one month after trauma, then it is a post-traumatic stress disorder (PTSD).

Among patients visiting emergency after latest trauma, quite a few is in acute stress reaction. However, this reaction is often incorrectly identified by healthcare team, due to lack of oriented medical examination, patients visiting about other complaints (pain, insomnia) and not expressing clearly the trauma context. Yet, it is know that acute stress reaction occurrence and existence of dissociate symptoms after trauma confrontation is considerably predictive of the eventual post-traumatic stress disorder occurrence.

The identification of risk population of post-traumatic stress disorder is not the subject of any particular structured procedure in emergency services while early care of these patients may allow limiting post-traumatic stress disorder occurrence and associate consequences. Previous works on the subject having exclusively targeted some trauma subgroups or some predictive factors subtypes, investigators propose here biopsychosocial global approach that can weight the impact of each parameters.

In this study, investigators aim at determining predictive biopsychosocial factors of the post-traumatic stress disorder occurrence at 3 months in patients visiting emergency after latest trauma (less than one month old) and identified as "high-risk" to develop post-traumatic stress disorder (moderate or high).


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged between 18 and 70
* Admitted in an emergency service after a trauma less than one month old, defined by death exposition or death threat, serious injury or sexual violence, by one or several of the following;

  * Being directly exposed ;
  * Being direct witness of traumatic event that occurred to other people;
  * Hearing that traumatic event arrived to close family member or close friend. In the case of death penalty or death threat of a family member or a friend, events must have been violent or accidental.
  * Being exposed repeatedly or extremely to aversive characteristics of trauma events (for example: first line actors gathering human remains, cops exposed several times to kid sexual abuse explicit fact).
* Written informed-consent
* Affiliation to the French social security scheme or beneficiary of a similar scheme

Exclusion Criteria:

* Patient not understanding French language
* Patient under guardianship
* Clinical instability making impossible the realization of questionnaires (for example: agitation, vital risk, disorders of consciousness...)
Emollients in the Management of Atopic Dermatitis

The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Age between 2 and 6 years included,
* Presenting with atopic dermatitis, with at least one duly documented flare treated by corticosteroids within the previous 6 months, and presenting a current flare (objective Scoring for Atopic Dermatitis (SCORAD score) is \[15-40\] at inclusion),
* After treatment of the current flare, patients should have for randomization an Objective SCORAD score \< 15, with Xerosis intensity≥ 1 and no subjective signs

Exclusion Criteria:

* Severe form of atopic dermatitis requiring either systemic corticosteroid treatment and/or antibiotic or antiviral treatment and/or hospitalisation,
* Primary bacterial, viral, fungal or parasitic skin infection,
* Ulcerated lesions, acne or rosacea,
* Dermatological disease other than atopic dermatitis which could interfere with the assessment,
* Immunosuppression,
Feasibility Study of PneumRx's Lung Volume Reduction Coil (LVRC)

This is a multicenter single arm open label study. The primary objective is to evaluate the safety and effectiveness of the Lung Volume Reduction Coil (LVRC) for the treatment of patients with emphysema in multiple centers.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 35 years of age
* bilateral heterogenous emphysema
* Patient has stopped smoking for a minimum of 8 weeks
* Read, understood and signed the Informed consent form

Exclusion Criteria:

* Patient has a history of recurrent significant respirator infection
* Patient has an inability to walk \> 140 meters
* Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
* Patient is pregnant or lactating
* Patient has clinical significant bronchiectasis
* Patient has had previous LVR surgery, lung transplant or lobectomy
* Patient has been involved in other pulmonary drug studies within 30 days prior to this study
Influence of Albumin on Acute Renal Dysfunction Associated With Cardiac Surgery Under Extracorporeal Circulation

Acute renal dysfunction associated with cardiac surgery (DRA-ACC) in our hospital population affects 39% of patients, being an important cause of morbidity and mortality, increasing the need for dialysis and assuming a prolongation of stay in the unit of intensive care, as well as an increase in the economic cost.

In this sense, extracorporeal circulation (CPB) is a clear aggression for renal function due to multiple effects, not entirely known.

Human albumin is sometimes used as part of the priming of the CEC circuit in variable concentration according to published centers and studies, demonstrating benefits on the maintenance of plasma oncotic pressure during the period of ECC, as well as other effects that can protect renal function during this period of renal injury.

Despite the use of albumin in the ECC priming both in Spain and in other countries, there are currently no published studies demonstrating the effect of albumin on renal function administered during CPB in cardiac surgery during the postoperative period. with a high incidence of kidney injury, although there are current studies that confirm a decrease in the incidence of kidney injury in patients with hypoalbuminemia and who undergo heart surgery without extracorporeal circulation.

The hypothesis of this study is based on the potential protective effect of albumin on renal function in patients undergoing heart surgery under CPB, in which there is a high incidence of postoperative hypoalbuminemia.

This study aims to obtain information about the effect that albumin can have in this population of patients with a high incidence of acute renal dysfunction, and if this benefit exists, whether it is significant or not to justify its systematic use.

This study is aimed to analyze the effect of the use of human albumin during ECC on the incidence of ARD-ACC in patients undergoing cardiac surgery with CPB diagnosed according to the KDIGO scale during the first 7 days after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years) scheduled for cardiopulmonary bypass surgery with Glomerular Filtration Rate (GFR) greater than or equal to 60 and left ventricular ejection fraction greater than or equal to 40%

Exclusion Criteria:

* Patients who do not meet the inclusion criteria and those who have a history of allergic reactions to human albumin, as well as those who have received iodinated contrast during the 7 days prior to surgery and pregnant women, will be excluded from the study.
Effect of Multiple Micronutrient Supplementation on Growth, Morbidity, and Mortality of HIV Infected Children in Uganda

Micronutrient deficiencies are common in HIV infected children and are aggravated by poor nutrition, especially in poor resource countries such as Uganda. It appears that micronutrient deficiencies contribute to immune dysfunction, increased morbidity and HIV disease progression. Hitherto, there has been no randomised controlled trial to assess the effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected children in Africa. Therefore, the investigators shall carry out a randomised controlled trial to determine the effect of multiple micronutrient supplementation on morbidity, weight gain and mortality among HIV infected children aged 1 to 5 years in Uganda.

Hypothesis: Daily administration of twice the recommended dietary allowance (2RDA) of multiple micronutrients to HIV infected children aged one to five years, for 6 months, will reduce all cause mortality from 24% to 14.4% in one year and result in a weight gain difference of 150 grams.

Micronutrient deficiencies are common in HIV infected children and are aggravated by poor nutrition, especially in poor resource countries such as Uganda. It appears that micronutrient deficiencies contribute to immune dysfunction, increased morbidity and HIV disease progression. Hitherto, there has been no randomised controlled trial to assess the effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected children in Africa. Therefore, the investigators shall carry out a randomised controlled trial to determine the effect of multiple micronutrient supplementation on morbidity, weight gain and mortality among HIV infected children aged 1 to 5 years in Uganda.

Hypothesis: Daily administration of twice the recommended dietary allowance (2RDA) of multiple micronutrients to HIV infected children aged one to five years, for 6 months, will reduce all cause mortality from 24% to 14.4% in one year and result in a weight gain difference of 150 grams.

A sample size of 373 was calculated assuming that the mortality risk in one year in HIV infected children is 24% (Barhane et al) and that this risk will be reduced to 14.4% in the intervention group (40% effect size) with 90% power and 95% confidence.

Assuming a 10% attrition rate (38 study participants), the final sample size in each group is 411.

Eligibility Criteria:
Inclusion Criteria:

* Aged 1 to 5 years
* HIV infection (previously confirmed by 2 ELISAs for children \> 18 months; DNA PCR for those \< 18 months)
* Informed consent from the parent/caretaker
* Ability to return for follow-up (lives within a radius of 15 km from hospital and unlikely to change residence during the course of the study)

Exclusion Criteria:

* Children already enrolled in other studies
* Children with severe abnormalities which are likely to impair oral intake (for example, severe cerebral palsy)
* Severely ill children requiring urgent admission and resuscitation
A FOUR SESSION ONLINE OCCUPATIONAL THERAPY GROUP TRANINIG FOR MOTHERS OF CHILDREN WITH FEEDING PROBLEMS

Feeding problems such as selective eating, loss of appetite, and mealtime behavior problems are common in childhood. Parents play a primary role in learning about feeding, and difficulties experienced in this process may cause the parent to experience stress, despair and exhibit incorrect attitudes. The aim of this study is to examine the effect of online occupational therapy group training for mothers on mothers' attitudes and stress levels, and children's eating behaviors. Mothers of children aged 3-6 years with feeding problems (n=29) were randomly divided into groups. Early Childhood Adaptive Eating Behavior Scale, Feeding Process Mother Attitudes Scale and State-Trait Anxiety Inventory scales were used for evaluation. The mothers in the research group participated in the 4-week training. As a result of the research, positive effects were found on mothers' attitudes and children's eating behaviors (p\<0.05). There was no change in mothers' state and trait anxiety levels (p\>0.05). This study shows that online group training to mothers can support existing therapies and guides clinicians working in the field.


Eligibility Criteria:
Inclusion Criteria:

* Being a mother with a child between 37-72 months of age,
* Experiencing feeding problems with their child,
* Having the ability to understand the training and comprehend the scale items,
* Volunteering to participate,
* Having the competence to use online platforms, tools, and the internet connection.

Exclusion Criteria:

* Receiving special education and/or occupational therapy sessions due to any risk,
* Having any chronic disease or disability in their child.
LED Treatment to Improve Cognition and Promote Recovery in TBI

This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).

The most common traumatic brain injury (TBI)-associated problems are cognitive deficits and neuropsychiatric problems, such as sleep disturbance and PTSD. This study evaluates a novel neuromodulation intervention, light emitting diodes (LED), for treatment of patients with TBI. LED is a noninvasive, non-thermal, painless treatment, which does not involve any needles or any form of surgery. LED treatment improves cellular activity of the brain tissue that has been damaged by TBI. Half of the study participants will receive active LED treatment, and a control group will receive sham LED. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* OEF/OIF active-duty personnel or Veterans with history of TBI or blast-exposure
* Meets criteria for mild TBI
* LOC of 30 min or less
* Age: 21-55
* Primary language is English

Exclusion Criteria:

* Evidence of penetrating head injury
* History of previous neurological diagnosis
* History of previous psychotic disorder prior to TBI
* Hearing or vision impairment
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema

The treatment of lymphoedema and its associated complications represent a considerable drain on increasingly limited NHS resources. Intermittent pneumatic compression, specifically the LymphAssist (Huntleigh Healthcare), represents an innovative treatment for this condition but the efficacy of this device needs to be investigated via robust clinical research.

This feasibility study aims to evaluate a proposed methodology designed to assess the efficacy of IPC in the treatment of lymphoedema. The study methodology consisted of a pilot randomised control trial of IPC plus standard lymphoedema care versus standard lymphoedema care alone. Feasibility outcomes included impact on lower limb volume.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over,
* Able to provide written consent,
* Confirmed diagnosis of lower limb ISL stage II or III.

Exclusion Criteria:

Any of these conditions

* Severe congestive heart failure
* Severe skin problems, lower limb ulcers or wounds.
* Presence of cognitive impairment (permanent or intermittent) which would prevent patients from using the IPC device safely or adhering to instructions/study protocol.
* Non-pitting chronic lymphoedema.
* Known or suspected deep vein thrombosis.
* Pulmonary embolism.
* Thrombophlebitis.
* Acute inflammation of the skin (erysipelas, cellulitis).
* Uncontrolled/severe cardiac failure.
* Pulmonary oedema.
* Ischaemic vascular disease.
* Active cancer diagnosis.
* Active metastatic diseases affecting the oedematous region.
* Oedema at the root of the extremity or truncal oedema.
* Severe peripheral neuropathy.
Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)

The goal of this clinical trial is to assess the efficacy and safety of multiple doses of foselutoclax (UBX1325) in patients with Diabetic Macular Edema. The main questions the study aims to answer are:

* Assess the efficacy of foselutoclax compared to aflibercept
* Assess the safety and tolerability of foselutoclax

This study is intended to assess the efficacy and safety of foselutoclax, a phosphate pro-drug, and its active parent molecule (UBX0601, a BCL-xL inhibitor) following repeat intravitreal (IVT) injections of foselutoclax in patients with Diabetic Macular Edema (DME).

Approximately 50 patients will be enrolled and randomized 1:1 into either the foselutoclax arm,10 μg given 8 weeks apart, or the control arm of aflibercept, 2 mg every 8 weeks in order to assess the primary objective. All patients will be followed for approximately 36 weeks.

The injector will be unmasked but the evaluator will remain masked throughout the study.

This study will enroll participants ≥18 years of age with active DME disease despite treatment, with best corrected visual acuity (BCVA) between 70 to 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (equivalent to 20/40 to 20/250 on the Snellen chart). Once patients meet inclusion/exclusion criteria, patients will receive 3 run-in injections of aflibercept approximately 4 weeks apart, with the last aflibercept injection 4-6 weeks prior to Day 1.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years.
* Patients with nonproliferative DR and DME
* Center-involved DME with Central Subfield Thickness (CST) ≥325-900 μm
* BCVA in the SE (most affected) of 70 to 30 ETDRS letters (equivalent to 20/40 to 20/250 on the Snellen chart)

Exclusion Criteria:

* Concurrent disease in the study eye (SE) or structural damage, other than DME, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or Color Fundus Photography (CFP) in the SE.
* Significant media opacities, including cataract, or posterior capsule opacification, which might interfere with VA, assessment of toxicity, or fundus imaging in either eye.
* Any medical condition that is uncontrolled and may prevent participation in this study, as determined by the Investigator or disqualify individuals from enrollment.
Endocytoscopy for in Vivo Determination of Mucosal Inflammatory Cells and Intestinal Disease Activity in Inflammatory Bowel Disease (IBD)

Precise activity assessment of inflammatory bowel disease (IBD) is essential to determine the extent and severity of the disease for further specific therapy. Nevertheless, despite ongoing developments in the field of gastrointestinal endoscopy, the final diagnosis still relies on the interpretation of histopathological features of intestinal biopsies taken during the endoscopic examination. Recently, endocytoscopy (EC) was introduced as a new endoscopic imaging modality, enabling microscopic imaging within the mucosal layer of the gut at a magnification level of up to 1400-fold.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age 18-85 years
* Ability of subjects to understand character and individual consequences of clinical trial
* Subjects undergoing colonoscopy
* Patients with known Crohn´s disease or ulcerative colitis

Exclusion Criteria:

* Inability to provide written informed consent
* Severe Coagulopathy (Prothrombin time \< 50% of control, Partial thromboplastin time \> 50 s)
* Impaired renal function (Creatinine \> 1.2 mg/dl)
* Pregnancy or breast feeding
* Active gastrointestinal bleeding
* Known allergy to methylene blue or toluidine blue
* Residing in institutions (e.g. prison)
A 6-month Efficacy, Safety, and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy

The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).


Eligibility Criteria:
Inclusion Criteria:

* Must sign an Informed Consent Form
* In remission from past HE
* Uses appropriate birth control measures
* More than or equal to 18 years of age
* Must have potential to benefit from treatment
* Recent prior HE episodes
* Capable and willing to comply with all study procedures
* Participant has personal support available
* Has a certain Model End Stage Liver Disease (MELD) score
* Recent transjugular intrahepatic portosystemic shunt (TIPS) placement or revision

Exclusion Criteria:

* Significant medical conditions, medical conditions that may impact study participation, or Investigator decision not to include
* Allergies to the study drug or similar drugs
* Laboratory abnormalities
* Recent participation in another clinical trial
* History of non-compliance
* Pregnant or at risk of pregnancy, or is lactating
* Recent alcohol consumption
* Active bacterial or viral Infections
* Bowel issues
* Active malignancy
* On a prohibited medication
* Liver transplant expected in near term
* Lactulose intolerance
* Participant shows presence of intestinal obstruction or has inflammatory bowel disease
* Ongoing or recent GI bleed
Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine

Migraine is characterized by attacks of throbbing, moderate or severe headache, often associated with nausea, vomiting, and/or sensitivity to light and/or sound. The study will assess safety and tolerability of atogepant when added to BOTOX, as well as prospectively evaluate the efficacy of add-on atogepant for migraine prevention. Adverse events and change in disease activity will be monitored.

Atogepant is an investigational drug being developed to prevent chronic migraine. Approximately 75 adult participants will be enrolled at approximately 30 sites in the United States.

All participants will receive atogepant oral tablet once a day (QD) during the 24-week treatment period, in addition to their standard of care Botox.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* At least a 1-year history of chronic migraine (CM), with or without aura, consistent with a diagnosis according to International Classification of Headache Disorders 3rd edition (ICHD-3 2018) and with or without acute medication overuse as defined in the protocol.
* Must be currently treated with BOTOX for CM: treated with \>= 2 treatment cycles in the 8 months prior to Visit 2 (Day 1) with documentation of payer authorization or written attestation of self-pay to support continued use of BOTOX.
* Must have 8 to 23 (inclusive) migraine days in the electronic diary \[eDiary\] screening/baseline period (eDiary data must have been collected for at least 20 days).

Exclusion Criteria:

* Use of opioid-containing products for more than 4 days per month for acute treatment of headache in the 3 months prior to Screening or during the screening/baseline period.
* Treatment of study target muscles using acupuncture, transcutaneous electrical nerve stimulation (TENS), cranial traction, dental splints for headache, or head and/or neck injections of anesthetics/steroids within 4 weeks prior to Screening and throughout the study.
* Concurrent use of any migraine prevention treatment other than BOTOX (required concomitant medication; or topiramate \<=100mg daily) including use of oral gepants in the 4 weeks prior to screening nor during the screening/baseline period.
* Current use or use within the 6 months (24 weeks) prior to Screening, of mAbs blocking the CGRP pathway.
* Concurrent use of oral gepants for acute migraine treatment in the 4 weeks prior to screening nor during the screening/baseline period.