cyrilzakka/clinical-trials huggingface dataset:
UCLA Fitness and Memory Study of Activity In Mild Cognitive Impairment (AIM)

This project will examine the relationship between physical activity levels, brain structure and memory function in adults with Mild Cognitive Impairment (MCI) aged 60 to 75. The study will follow 30 adults with age-associated memory impairment or MCI over the course of 18 months. During this time, subjects' physical activity levels will be measured regularly and related to both the thickness their hippocampus and to their memory performance. Subjects will be recruited and screened for major health problems at UCLA. Physical activity will be tracked for two weeks using accelerometers at baseline and every 6 months during the study. At baseline and at the end of the study, subjects will undergo a structural MRI brain scan to measure hippocampal thickness, as well as a neuropsychological evaluation to measure memory function. The study will seek to determine the relationship between physical activity level, hippocampal thickness and memory performance in older adults with age-associated memory impairment.


Eligibility Criteria:
Inclusion Criteria:

* Agreement to participate in the study
* 60-89 years of age
* Diagnostic criteria for Mild Cognitive Impairment diagnosis: subjective memory complaints, Montreal Cognitive Assessment score of \<26, intact instrumental activities of daily living (Smith et al., 1996) OR subjective age-associated memory complaints
* Cohabitation with an adult capable of ensuring correct usage of the physical activity monitors during the study and verifying self-reports of activity levels.
* Adequate visual and auditory acuity to allow neuropsychological testing.
* Screening laboratory tests and EKG without significant abnormalities that might interfere with the study. If screening laboratory tests or EKG show abnormalities, PI may request clearance from primary care physician before subject continues in study.

Exclusion Criteria:

* Comorbid conditions impacting mobility
* Current, untreated depression: BDI-II score \>13
* Diagnosis of probable Alzheimer's disease (AD) or any other dementia (e.g., vascular, Lewy body, frontotemporal).
* Evidence of other neurological or physical illness that can produce cognitive deterioration. Volunteers with a history of head trauma, stroke, TIA, carotid bruits, or lacunes on MRI scans will be excluded.
* Contraindication to the MRI including claustrophobia, metal in body, surgery within 60 days, certain medical implants or previous abnormal MRI results.
* History of cardiovascular disease
* Uncontrolled hypertension (systolic BP \> 170 or diastolic BP \> 100)
* Current diagnosis of any major psychiatric disorder according to the DSM-IV TR criteria (APA, 2000), including current alcoholism or substance addiction.
* Current use of marijuana
* Previous use of marijuana for at least 15 days in a month, initiating use during adolescence and continuing for at least one year
Management of Pediatric Distal Radius Fractures : Conservative Treatment Versus Surgical Reduction

To compare functional and radiological assessment between two groups of children with displaced distal radius fractures : those who will receive surgical reduction and those who will not.

Distal radius fractures are the most frequent fractures seen in pediatric population accounting for about 20-30% of all fractures in children , for the non-displaced pediatric distal radius fractures , it is agreed widely to be just managed by an immobilization cast in the emergency department . However when it comes to the displaced fractures , Different centers have different options of management , mostly including either the surgical anatomical reduction under general anesthesia then casting with or without using other fixation method which is mostly k-wires , or the other option includes only casting in the emergency department without trial of reduction or just a trial of realignment under sedating agent , this second option depends on the unique phenomenon of remodeling in the pediatric fractures , as Unlike adults, in growing children, remodeling can restore the alignment of the displaced fractures to a certain extent, making anatomical reduction less essential , specially when it comes to distal radius as The distal radial and ulnar physes are responsible for about 80% of forearm length and for 40% of upper limb length that making their remodeling potential can approach upto 100% . depending on that the question was that if the fracture will be fully remodeled with no functional or range of motion disturbance on the conservative option so what the essentiality of the surgical option can be . along with exposing the child to the dangers of general anesthesia , the minor complications that can occur with k wires (as neuropraxia , pin tract infection or migration of the k wire) , emotional and financial load . in a cost analysis for different options of treatment in displaced pediatric distal radius fractures , the cost of surgical option exceeds the conservative one by multiple times . According to that a lot of the current literature have suggested to consider conservative treatment of pediatric displaced distal radius fractures to be the gold standard and fundamental option of treatment . In this study the investigators question the effectiveness of conservative treatment to displaced pediatric distal radius fractures (casting in the emergency department) in comparison to the surgical anatomical reduction in matters of functional and radiological parameters .

Eligibility Criteria:
Inclusion Criteria:

* All children aged 3 to 10 years
* both genders
* patients presenting with displaced distal radius fractures

Exclusion Criteria:

* intra articular fractures
* Greenstick and buckle fractures
* fractures with more than 1 week duration
* non displaced fractures
* Salter Harris fractures
* open fractures
* fractures with neurovascular bundle injury
* poly trauma patients
* patients with pathological bone diseases as Osteogenesis Imperfecta or CP (cerebral palsy) .
* Galeazzi fractures
Cold Plasma for Wound Treatment, Safety Study

In this study the application of cold atmospheric plasma (CAP) will be tested on intact skin of volunteers. To test safety, several skin parameters will be monitored, the antimicrobial effect will be investigated as well. The investigators expect this treatment to have a good antimicrobial effect with acceptable, transient skin sensations.

Control of infection and bacterial colonisation constitutes a continuing challenge in patients with burns. Prevention of microbial contamination and infection is vital for burn wound care as bacterial presence can result in excessive inflammatory reactions, delayed re-epithelialisation, impaired matrix remodelling and bacteraemia. A novel method to decrease the likelihood of infection and to help cure wounds is cold atmospheric plasma (CAP). CAP has been shown in vitro to kill a wide range of pathogenic bacteria.

This safety study aims to demonstrate the safety, efficacy and efficiency of CAP for burn wound treatment. Intact skin of volunteers will be CAP treated. Local skin reaction (blister formation, pain, itching), erythema, local skin temperature, trans epidermal water loss (TEWL) and reduction of the bacterial load wil be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to comply with the research protocol
* No language barrier

Exclusion Criteria:

* Atopic dermatitis or other skin disease
* Implanted electrical medical devices such cardiac pacemakers
* Pregnant or lactating women
* Patients with infected wounds.
* Life-threatening cardiac conductivity abnormality
* Active malignancy
* Women of childbearing age not using contraceptive measures
Nutritional Status Study of Inpatients in Hospitals

evaluating the nutritional status of inpatients with 7 catogories of diseases ( including digestive system, respiratory system, cardiovascular and endocrine system, tumor, nervous system, urinary system) within 24\~48 hours after admission. Among them, the Second Affiliated Hospital of Zhejiang University School of Medicine has undertaken 200 cases, and a total of 25 hospitals in zhejiang participated（5000 cases in total）.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients with 7 categories of diseases (including digestive system, respiratory system, cardiovascular and endocrine system, tumor, nervous system, and urinary system)
* Age ≥ 18
* 24～48h after admission

Exclusion Criteria:

* Age\<18
* Critically ill patient
* With mental illness and cannot think or behavior normally
* Any other serious or uncontrolled illness which the investigator think is undesirable for the patient to enter the trial
The Immune Response to Stroke

Some patients develop cognitive decline after a stroke, but we don't always understand the mechanisms. It has been proposed that a proportion of the patients develop an autoimmune immune response, and that this could potentially explain the cognitive decline in some of the patients. The current study aims to investigate this hypothesis in a subgroup of patients with stroke.


Eligibility Criteria:
Inclusion Criteria:

* Stroke \< 72 h
* Age \> 18 years

Exclusion Criteria:

* Brain hemorrhage verified by CT or MRI scan
* Previous or present immunological disease or other serious comorbidity
* Ongoing immune respons after infection or vaccination \< 1 month
* Cognitive without ability to understand and/or give an informed consent to participate in the study
Neurotrophic Factors and Depression

Study intended to determine if there are baseline differences in serum neurosteroid levels and neurotrophic factor (BDNF) levels in healthy controls vs unmedicated depressed subjects, and whether the levels of these change with antidepressant treatment. Study also intended to determine if baseline neurosteroid/ BDNF levels, and the change in these levels with =treatment, are correlated with clinical antidepressant response to escitalopram (Lexapro).

The study was approved by the UCSF Committee on Human Research, and all participants gave informed consent. The depressed subjects began treatment with placebo for one week, followed by escitalopram for eight weeks (10 mg per day x 4 weeks, followed by 20 mg per day x 4 weeks, as tolerated) in a double-blind, fixed-order, within-subject cross-over manner. The depressed subjects and the psychiatric rater were unaware of the study design and the sequence and duration of treatments. Depressed and control subjects underwent venipuncture to obtain blood for assays. The controls underwent venipuncture once, and the depressed subjects had venipuncture just prior to beginning active escitalopram treatment and again after 8 weeks of escitalopram treatment. Blood was also collected at Weeks 4 and 8 of treatment in the depressed subjects for assay of citalopram and citalopram metabolites, to gauge medication compliance. Finally, depression severity and global clinical change were assessed in the depressed subjects at Baseline and at the end of Week 8 of escitalopram treatment.

Eligibility Criteria:
Male subjects with unipolar Major Depressive Disorder (DSM-IV) with a minimum score of 22 on the 10-item Montgomery-Åsberg Depression Rating Scale (MADRS) who were medication-free for at least 6 weeks, were enrolled. Fifteen individually age-matched (+ 3 years) healthy male controls with no history of psychiatric illness were also enrolled. Subjects' ages ranged from 22- 55 y.o. (mean + S.D.= 41.4 + 8.75 y.o.). All subjects were required to pass a urine toxicology screen (assessing the presence of drugs of abuse) on the day of testing.

Exclusion Criteria:

Individuals with co-morbid panic disorder were excluded, since they may poorly tolerate typical starting doses of antidepressants , and individuals with co-morbid post-traumatic stress disorder were excluded, since they may have neuroendocrine regulatory responses different from those of depressed subjects without PTSD. Exclusion criteria for both groups included recent (within 6 months) alcohol or drug abuse as defined by DSM-IV criteria, concurrent psychotherapeutic interventions, poor medical health or abnormal clinical labs, active suicidality, and use of medications that could interfere with the study.
Clinical Randomisation of an Antifibrinolytic in Significant Haemorrhage

CRASH 2 is a large pragmatic randomised placebo controlled trial of the effects of the early administration of the antifibrinolytic agent tranexamic acid on death, vascular events and transfusion requirements. Adults with trauma who are within 8 hours of injury and have either significant haemorrhage, or who are considered to be at risk of significant haemorrhage, are eligible if the responsible doctor is for any reason substantially uncertain whether or not to use an antifibrinolytic agent. Numbered drug or placebo packs will be available in each participating emergency department. Randomisation will involve calling a 24-hour freecall randomisation service. The call should last only a minute or two and at the end of it the randomisation service will specify which numbered treatment pack to use. For hospitals where telephone randomisation is not feasible, randomisation will be by taking the next consecutively numbered treatment pack. No extra tests are required but a short form must be completed one month later or on discharge or on death (whichever occurs first).

See trial website for full protocol. This is an international trial with over 300 hospitals in about 40 countries worldwide.

Eligibility Criteria:
Inclusion Criteria:

All trauma patients with ongoing significant haemorrhage (systolic blood pressure less than 90 mmHg and/or heart rate more than 110 beats per minute), or who are considered to be at risk of significant haemorrhage, and are within 8 hours of the injury, are eligible for trial entry if they appear to be at least 16 years old. Although entry is allowed up to 8 hours from injury, the earlier that patients can be treated the better.

Exclusion Criteria:

The fundamental eligibility criterion is the responsible doctor's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular adult with traumatic haemorrhage. Patients for whom the responsible doctor considers there is a clear indication for antifibrinolytic therapy should not be randomised. Likewise, patients for whom there is considered to be a clear contraindication to antifibrinolytic therapy (such as, perhaps, those who have clinical evidence of a thrombotic disseminated intravascular coagulation) should not be randomised. Where the responsible doctor is substantially uncertain as to whether or not to use an antifibrinolytic, all these patients are eligible for randomisation and should be considered for the trial. There are no other pre-specified exclusion criteria
Early Non Invasive Ventilation in Immuno-compromized Patients With Acute Respiratory Failure.

Assess the superiority of early non invasive ventilation in comparison to Oxygen therapy only, for immuno-compromized patients with acute respiratory failure


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* ICU admission
* Acute respiratory failure defined by (PaO2\<60 mmHg at room air) or (polypnea \>30/min or dyspnea at rest) or respiratory distress. Since less than 72 hours.
* Immuno compromized patient defined by solid tumor (treated since less than 5 years) or haematological malignancy (treated since less than 5 years) or Solid organ transplantation or Stem cell transplantation or Immunosuppressive treatment (steroid \> 1mg/kg/d or \>1 month or other immunosuppressive treatment \>1 month)

Exclusion Criteria:

* Hypercapnia \>50 mmHg or increased of hypercapnia \>10 mmHg under Oxygen treatment
* Need of immediate mechanical ventilation
* Obvious cardiogenic oedema
* Vasopressor use \>0.03 µg/kg/min
* Glasgow Score \<13
* End of life decision
* Acute myocardial infarction
* Patient refusal
* Pregnancy
* No national health insurance
Cognitive Load Assessment of Helicopter Pilots in Training

The aim of this study is to identify the effect of the increase of the situation demands, with or without a thread, on military helicopter pilot's cognitive load, depending on their skills acquisition (at the beginning, midway and end of training course). This study is carried out on a simulator, in virtual reality and allows to identify the moments of cognitive load enhancement and the associated indicators such as subjective, physiological and behavioural indicators. Recommendations will be done to go towards an individualization of the lessons during the pilots education, by anticipating an overload which has a deleterious effect on learning.


Eligibility Criteria:
Inclusion Criteria:

* Being a trainee at the Instructional center of helicopter crews
* Being more than 18 years old
* Being insured under the French social security system
* Having the bases to pilot helicopters
* Having signed the non-opposition form

Exclusion Criteria:

* Being minor or an incapacitated adult
* Being in a motor handicap situation
* Having a cardiac pathology
* Having a visual pathology that is uncorrected by glasses or lens
* Having a bad audition
* Having a psychiatric disorder, a neurologic or organic disorder requiring a medical treatment
* Taking psychotropics
* Drinking more than 28 units of alcohol per week
* Being epileptic
In Vivo Computer-aided Prediction of Polyp Histology on White Light Colonoscopy

Our group, prior to the present study, developed a handcrafted predictive model based on the extraction of surface patterns (textons) with a diagnostic accuracy of over 90%24. This method was validated in a small dataset containing only high-quality images.

Artificial intelligence is expected to improve the accuracy of colorectal polyp optical diagnosis. We propose a hybrid approach combining a Deep learning (DL) system with polyp features indicated by clinicians (HybridAI). A pilot in vivo experiment will carried out.

Optical diagnosis aims to predict the histology of a polyp based on its endoscopic features. This practice could avoid histopathological analysis and reduce the derived costs. Under this premise, the American Society of Gastrointestinal Endoscopy (ASGE), in its Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) statement, established a diagnostic threshold for real-time endoscopic assessment of diminutive polyps. The rationale for its implementation is that the prevalence of advanced histology in polyps \< 5mm is very low (0.5%).

Several studies have demonstrated that optical diagnosis of small polyps is safe and feasible in clinical practice and comparable to the current gold standard, histopathology. However, the accuracy of optical diagnosis has been shown to be insufficient in community-based practices or in non-expert hands and the diagnosis is even more difficult in diminutive polyps \< 3 mm in which the discrepancy between the endoscopic and pathological diagnosis is about 15%.

Artificial Intelligence (AI) has emerged as a help tool for polyp characterization.

Aiming to improve optical diagnosis using AI methods, we propose a hybrid approach that combines DL with characteristics of polyps manually indicated by endoscopists (HybridAI).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Approval of participation in the study. Signature of informed consent
* Patients with at least one polyp of any size/morphology diagnosed in a routine or screening colonoscopy
* Endoscopies performed with high definition endoscopes

Exclusion Criteria:

* Age \<18 years
* Refusal to participate in the study
* Polyps partially resected in a previous endoscopy
* Patients with inflammatory disease
* Impossibility to wash remains of stool or mucus on the surface of the polyp
Changes in Heart Rhythms Associated With Antipsychotic Drug Treatment

This study is being done to look at the electrical activity of the heart. This study will help decide whether taking recordings for a 24-hour period gives more useful information than recording it for a few seconds in a doctor's office. The study will compare 24 hour electrocardiogram (ECG) results of patients taking thioridazine (Mellaril) to those of other patients taking different medications that took part in another study.

The objective of the study is to assess the Tpe and QTc measures in 24 hr Holter echocardiograms in patients treated with atypical antipsychotic drgs (APDs). The primary comparisons of interest are olanzapine (no QTc prolongation) to ziprasidone (QTc prolongation) and thioridazine (QTc prolongation) as well as ziprasidone (possibly low TdP risk) to thioridazine (TdP risk). Secondary comparisons will be among all APDs available. In a previously approved study, conventional 24 hr Holter electrocardiograms were recorded from a total of 78 subjects during the course of treatment with psychotropic medications and without medication (in the case of normals and unmedicated patients). These recordings will be analyzed to yield Tpe, QTc and heart rate, and other measures. Data from additional patients is needed, therefore this study will include only patients currently treated with Mellaril (thioridazine), Risperdal (risperidone) and Seroquel (quetiapine).

Eligibility Criteria:
Inclusion Criteria:

* Patients must be male or female, age 18-65

  * Patients must have a definitive diagnosis by DSM-IV criteria of schizophrenia, bipolar or schizoaffective disorder.
  * Patients can be receiving inpatient or outpatient treatment at time of enrollment.
  * Patients must have been treated with (Mellaril) thioridazine, (Risperdal) risperidone or (Seroquel) quetiapine at least three months at time of enrollment.
  * Patients must be able to provide written informed consent

Exclusion Criteria:

* Patients with a primary diagnosis other than schizophrenia, schizoaffective or bipolar disorder

  * Patients who are currently taking other medications that have been shown to prolong the QTC, including tricyclic antidepressants, fluoroquinolones or antiarrythmics.
  * Patients unable to provide written informed consent.
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.

The objective of this open-label extension is to assess the safety and tolerability of long-term treatment of the rotigotine patch in subjects with early-stage idiopathic Parkinson's disease.

This is the open-label extension to the randomized, double-blind, placebo-controlled SP512 trial that assessed the efficacy and safety and tolerability of the Rotigotine patch in subjects with early-stage idiopathic Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed six months of maintenance treatment in the SP512 double-blind trial

Exclusion Criteria:

* Subjects who had an ongoing serious adverse event from SP512 double-blind trial that was assessed as related to study medication