cyrilzakka/clinical-trials huggingface dataset:
A Study of Biomarkers of Mild Traumatic BRAIN Injury

Patients with mild traumatic brain injury (mTBI) represent a burden of patients admitted to the emergency department. According to the guidelines, a cerebral CT scan is indicated after mTBI according to the specific conditions. However, variability exists regarding the respect of these CT scan indications, and less than 10% of patients will have visible brain lesions on CT scan. Recently, serum Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) biomarkers have shown ability to differentiate normal and abnormal CT scan findings after mTBI. These encouraging results prompted us to launch a prospective study using automated and quick measurements of GFAP and UCH-L1 biomarkers to validate these findings.


Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old (France)
* Mild TBI (GCS 13-15 on admission) within 12 hours after injury
* Indication of brain CT scan:

  * neurological focal deficit
  * anterograde amnesia
  * Glasgow coma scale score \<15 after 2 hours post-TBI
  * suspicion of vault depression fracture
  * fracture of the basal skull
  * persisting nausea, vomiting or headache
  * post-TBI seizures
  * Pre-injury treatment with antithrombotic drugs
  * Loss of consciousness or amnesia with age \>65 years, fall \>1m or hit pedestrian
  * Other condition requiring CT scan according to the in-charge physician.

Exclusion Criteria:

* GCS 3-12 on admission
* Time of injury unknown
* Time to injury exceeding 12 hours
* Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous intracranial hematoma)
* Penetrating head trauma
* Patient with mechanical ventilation
* Pre-injury neurological disorder affecting the assessment of neurological outcome: dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumor, and history of neurosurgery, stroke or transient ischemic attack (TIA) within the last 30 days
* Venipuncture not feasible
* No realization of brain CT-scan
* Subject under judiciary control
* Pregnant or breastfeeding woman
* Subject in exclusion period of another study
Combined Illness Management and Psychotherapy in Treating Depressed Elders

The purpose of this research study is to test a program developed to help patients with chronic heart or lung problems take care of themselves and cope with their illness or limitations.


Eligibility Criteria:
Inclusion Criteria:

* Age 55 years or older
* Diagnosis of Heart Failure or COPD
* Depressive symptoms indicated by a BDI-II score of 10 or higher
* Functional impairment

Exclusion Criteria:

* Current psychotherapy
* Cognitive Impairment
* Psychiatric diagnosis
* Active suicidal thoughts
* Significant vision or hearing impairment
* Residence in long term care facility
Phase II Trial Evaluating Irinotecan and Capecitabine Relapsed/Refractory Upper GI Tumours

The objective of this study is to assess the efficacy and toxicity of a 3 weekly regimen containing irinotecan combined with capecitabine in the setting of relapsed or refractory upper gastrointestinal tumours. Patients with locally advanced or metastatic adenocarcinoma or squamous cell carcinoma originating from the oesophagus, oesophagogastric junction or stomach who have previously received chemotherapy and have either failed to respond or who have relapsed within 3 months after an initial response will be eligible for treatment in this study.

The response rate, failure-free survival and overall survival of treated patients will be evaluated. Toxicity and quality of life will also be monitored closely.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma or squamous cell carcinoma of oesophagus, O-G junction and stomach, not amenable to surgical resection.
* Bidimensionally measurable disease, or unidimensional measurable disease assessable by CT scanning, not within previously irradiated areas.
* Patients with progressive disease during previous chemotherapy treatment or within three months of stopping treatment.
* At least one previous chemotherapy regimen, given within 3 months prior to inclusion in this study.
* No previous exposure to irinotecan.
* Adequate bone marrow function with platelets \>100 X 109/L; WBC \> 3 X 109/L; Neutrophils \> 1.5 X 109/L at the time of study entry.
* Satisfactory renal function. Creatinine clearance (measured by Cockcroft and Gault) \>50ml/min and Cr \<135.
* Satisfactory liver function:
* In the absence of liver metastases: Bilirubin \< 1.25N (N=upper limit of normal range) Hepatic transaminases \< 2.5N Prothrombin time \< 1.5N
* In the presence of liver metastases: Bilirubin \< 1.5N Hepatic transaminases \< 5N Prothrombin time \< 1.5N
* No uncontrolled medical condition
* No previous malignant disease except for non-melanotic skin cancer or in-situ carcinoma of the uterine cervix.
* ECOG performance status of 0, 1 or 2.
* Predicted life expectancy of \> 3 months.
* Adequate contraceptive precautions
* Informed written consent

Exclusion Criteria:

* Medical or psychiatric conditions resulting in inability of patient to give written consent.
* ECOG Performance status \>2
* Intracerebral metastases or meningeal carcinomatosis
* Unresolved bowel obstruction
* Creatinine clearance \<50ml/min, Cr \>135
* Uncontrolled angina pectoris, heart failure (New York heart classification 3 or 4).
* Pregnancy/lactation
* Previous malignancy other than adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ.
Effects of Back Muscles Endurance Training in Patients With Chronic Mechanical Low Back Pain

Low back pain is one the leading cause of disability and affecting many individuals. Chronic low back pain is associated with restriction in daily physical activities that ultimately leads to disuse atrophy of muscles. The objective of the study is to find out the effects of Back Muscles Endurance Training on pain, disability, endurance and Lumbar flexibility in patients with chronic mechanical low back pain.

Low back pain is the leading worldwide cause of years lost to disability and its burden is growing alongside the increasing and ageing population. Mechanical low back pain refers to back pain that arises intrinsically from the spine, intervertebral disks, or surrounding soft tissues. Repetitive trauma and overuse are common causes of chronic mechanical low back pain, which is often secondary to workplace injury. Most patients who experience activity-limiting low back pain go on to have recurrent episodes. Low back pain is a common condition affecting many individuals at some point in their lives. Chronic low back pain prevalence increases linearly from the third decade of life on, until the 60 years of age, being more prevalent in women.

Eligibility Criteria:
Inclusion Criteria:

* The ages between 20-45 years
* Both Males and Females
* The presence of low back pain as a primary complaint
* The onset of pain at least three months back

Exclusion Criteria:

* Tumors, infection or inflammatory diseases affecting the spine
* Spinal or lower limb surgery
* Spinal fractures or structural deformities such as spinal stenosis, spondylolisthesis and spondylolysis
* Signs of nerve root compression
* Any contraindications for exercise therapy
* Patient with any spinal surgery, have respiratory or systemic diseases.
* Pregnant women.
* Sacroiliac joint dysfunction (determined by any three positives among distraction test, Gaenslen's test, Thigh thrust test, Sacral thrust test, and compression test)
Moral Judgements and Choices of Caregivers in the Time of COVID-19 Pandemic

The XPHI-COVID19 randomized study aims to investigate the mechanisms of moral judgements in a population of caregivers, using a survey, with the results to the Oxford Utilitarianism Scale as primary outcome.


Eligibility Criteria:
Inclusion Criteria:

* All caregivers from french public healthcare center with Intensive Care Unit
* Agreement

Exclusion Criteria:

* Refuse to participate or withdraw agreement
Whipple Procedure: A 5-year Clinical Experience in Tertiary Care Center

The study was conducted in tertiary care hospital of Lahore. Patient undergoing Whipple procedure were studied by compiling demographic details of the patients, common presenting symptoms, various indications for Whipple's procedure, the cofactors which affect the procedures outcome and morbidity and mortality of the patients.

This study was performed by collecting data through predesigned questionnaire about patients undergoing Whipple's procedure from operation theatres and medical record section. Those patients, whose tumor was unresectable and undergone palliative surgical procedures were excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* patients of both sexes with age ranging from 20 years to 70 years
* patients with pancreatic tumors
* patients with adequate cardiorespiratory reserves to be fit for prolong general anesthesia

Exclusion Criteria:

* unresectable tumors
* unfit for surgery
The Effect of Simulation-based Training on Nursing Students

This research will be carried out with the aim of making this practice practical with simulation-based training and improving cognitive, affective and psychomotor skills, and then applying it in the clinic, before applying the nasogastric tube placement application, which is included in enteral nutrition, to the child in the clinic.

The fact that children react according to their age and cannot be considered separately from their families makes it difficult for nurse students to apply to the child group. When it comes to interventions that may cause stress/pain/discomfort, it can be even more difficult to manage the reactions of the child and family. By using the simulation method, the problems that make this type of teaching difficult can be reduced.For this reason, the aim of this study is for student nurses to make this practice practical with simulation-based training and to develop cognitive, affective and psychomotor skills before applying nasogastric tube placement, which is included in enteral nutrition, to a real child in the clinic, and then to apply it in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Studying in the 3rd year of the Faculty of Health Sciences, Nursing Department of Yüksek İhtisas University and Biruni University,
* Having successfully completed the clinical application of the Fundamentals of Nursing course, Internal Medicine Nursing course and Surgical Diseases Nursing course and not repeating the grade,
* Those who will take the Child Health and Diseases Nursing course for the first time,
* Students who volunteer to participate in the research will be included.

Exclusion Criteria:

* Having received training on enteral nutrition in children,
* Simulation training,
* Students coming from other health departments (such as anaesthesia, laboratory technician, elderly health personnel) or from health vocational high schools as nursing will be excluded.
* Students who want to exit the research at any stage of the research will be excluded from the research.
Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).


Eligibility Criteria:
Inclusion Criteria:

* Infection with HCV genotype 2 or 3
* Had cirrhosis determination
* Prior treatment failure
* Screening laboratory values within defined thresholds
* Subject had not been treated with any investigational drug or device within 30 days of the screening visit
* Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

* Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
* Pregnant or nursing female or male with pregnant female partner
* Current or prior history of clinical hepatic decompensation
* History of clinically significant illness or any other major medical disorder that may have interfered with subject treatment, assessment or compliance with the protocol
* Excessive alcohol ingestion or significant drug abuse
Effects of a Single Dose of Brazil Nuts on Blood Lipids

Several studies have shown that regular intake of nuts may improve blood lipids. However, few studies have investigated the effects on blood lipids after a single intake of nuts. The present study was conducted in order to evaluate the acute effects of a single intake of Brazil nuts on blood lipids.

The study was a non-blinded randomized controlled study with 52 participants, 26 participants in both the Brazil nut group and in the control group. Blood tests were taken at baseline and 3h, 6h, 24h, 7d and 14d after ingestion of either 50g Brazil nuts or an isocaloric amount of coconut flakes. We then conducted an unpaired t-test in order to compare changes in blood lipids between the two groups. P-values \< 0.05 were considered statistically significant


Eligibility Criteria:
Inclusion Criteria:

* Patients who participated in a rehabilitation program over three weeks at a rehabilitation center. Participants were at the rehabilitation center due to rheumatic diseases or chronic pain conditions / fibromyalgia.

Exclusion Criteria:

* Food allergy, lactose intolerance, celiac disease, mild illness for the last 3 weeks (infections or inflammatory conditions), serious illness (eg. heart attack) or undergone surgery during the previous 3 months, intake of Brazil four weeks prior study enrollment, using cholesterol-lowering or blood-thinning drugs, planning to eat more than one meal in other places than the rehabilitation center during the study.
Study in Beta-thalassaemia or Myelodysplastic Syndrome Patients to Investigate the Safety and Tolerability of SLN124

The primary purpose of this study is to determine the safety and tolerability of SLN124 for the treatment of non-transfusion-dependent (NTD) β-thalassaemia and low risk myelodysplastic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18yrs; BMI 18-35 kg/m2
* β-thalassaemia intermedia or compound heterozygous HbE/β-thalassaemia
* Non-transfusion dependent: ≤ 5 units red cells in last 6 months and transfusion-free for ≥8 weeks
* Hb between 5 \& 11 g/dL
* Ferritin \> 250 µg/L and /or liver iron ≥ 3mg Fe/g dry weight and TSAT \>40%

Exclusion Criteria:

* Haemoglobin S/β-thalassaemia, homozygous β-0 thalassaemia or α thalassaemia
* ALT/AST \> 1.5 x upper limit normal or cirrhosis
* eGFR \< 60 mL/min/1.73m2
* Platelets \<100 or \> 1000 x 109/L
* Untreated B12/folate deficiency
* Iron chelation therapy unless stable for ≥8 weeks
* Daily NSAID, therapeutic dose anticoagulant, ESA ≤12 weeks or stable dosing of hydroxyurea ≤ 6 months
* Significant cardiac disease (MI in 6 months, NYHA class III-IV heart failure, long QT)
* HIV or active hepatitis B/C or malignancy within 5 year
Retroperitoneal Ligation of Uterine Artery in Total Laparoscopic Hysterectomy for Enlarged Uterus

This randomized trial is aimed to investigate the role of retroperitoneal TLH in enlarge uterus.

Laparoscopic hysterectomy is one of the most common gynecologic surgeries worldwide. Generally, in total laparoscopic hysterectomy (TLH), uterine arteries are coagulated or transected close to the uterus, alongside the cervix, like surgical technique of a conventional total abdominal hysterectomy. Recently, several studies showed that ligation of uterine artery where it originates from the internal iliac artery during TLH (so-called "retroperitoneal TLH") is effective for reducing blood loss. However, the application of this technique to clinical practice have not been well investigated in terms of its efficacy and safety. Moreover, most of the previous studies on retroperitoneal TLH were small case series or retrospective comparative studies with conventional TLH. Therefore, the investigators conducted this randomized trial to investigate the role of retroperitoneal TLH in enlarge uterus.

Eligibility Criteria:
Inclusion Criteria:

* absence of pregnancy at the time of presentation
* uterine volume between 12 and 18 weeks of gestation by pelvic examination
* appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

Exclusion Criteria:

* any suggestion of malignant uterine or adnexal diseases
* any major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance
* an inability to understand and provide written informed consent.
Performance of AclarusDx® a Blood-Based Transcriptomic Test for AD, in French Patients Newly Referred to a Memory Center

The purpose of this study is to assess the performance of AclarusDx™, an investigational blood test detecting gene expression information, and intended to help physicians in making an Alzheimer's Disease diagnosis in patients having memory complaint and/or cognitive impairments.

The objective of this study is to apply AclarusDx™ signature in 600 patients newly referred in french memory centers. Only AclarusDx™ will be added to the panel of tests usually performed at the centers to establish diagnosis. AclarusDx™ will be used for investigational use only, not for diagnostic purpose. The ultimate goal is to define the clinical utility of AclarusDx™ to provide physicians with a tool that will help them in making the diagnosis of Alzheimer's Disease (AD).

The primary objective is to estimate the prevalence of positive AclarusDx™ in patients diagnosed AD in the population of primary consultants. This population of primary consultants consists of patients with cognitive impairment and / or a memory complaint requiring specialized exploration using AclarusDx™ blood test and which may be potentially related to multiple and different etiologies.

The secondary objectives are:

* Assess the prevalence of positive AclarusDx™ in relation to other diagnoses (MCI, vascular dementia ...) established by the physician investigator at the end of specialized assessment.
* Identify the demographic factors anamnestic, clinical, biological and imaging associated with positivity of AclarusDx™
* Identify the demographic factors anamnestic, clinical, biological and imaging associated with the diagnosis of AD and other diagnoses.
* Determine the contribution of AclarusDx™ in the usual battery of tests performed for diagnostic approach to Alzheimer's disease and to identify a possible association of interest with one or more endpoints (clinical, neuropsychological, brain, biological imaging).
* Assess: diagnostic status at 6 and 12 months, and the MMSE and IADL at 6 and 12 months.
* assess the predictive value of AclarusDx™ achieved during the initial visit to the diagnosis of AD is 12 months.
* Evaluate AclarusDx™ predictive value to 12 months

Eligibility Criteria:
Inclusion Criteria:

* male and female adult patients
* suffering from cognitive impairment and/or memory complaint and justifying a first clinical investigation at the memory center

Exclusion Criteria:

* patient already followed up by the memory center
* patient unable to comply with study procedures
Knee Muscle Force Recovery After Minimally Invasive Surgery (MIS) Total Knee Replacement (TKR)

To compare muscle torque recovery between patients under subvastus approach and those under midvastus approach after total knee replacement

Total knee Arthroplasty is a common operated surgery in each hospitals, and a lots of patients benefit from this surgery. Traditionally the frequently used surgical approach is parapatellar approach. However, recently the subvastus and midvastus approach has gained a world-wide population. These two methods had less damage to the quadriceps tendon and theoretically should have better post-operative muscle power recovery, less lateral retinaculum release because of better patellar tracking. The only differences between these two approaches are that the midvastus approach will split the vastus medialis muscle and denervation may occur. In this study we will use HSS or KSS functional score and Cybex dynamometer to evaluate the functional recovery, and use Merchant's view radiography to evaluate the result of patellar tracking. The follow-up period will not be limited and we will use mixed-model statistic's random effect to gain the natural history of muscle power recovery, which will become the base of other study. We can also compare the difference of results between PS type and CR type and different surgical approach. The natural history of the knee score will also be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients after subvastus approach or midvastus approach total knee replacement

Exclusion Criteria:

* patients with severe hypertension, heart disease or other problems which negatively influence the security of muscle test
He-move-philia, Lifestyle Intervention for Patients With Hemophilia

The main objectives are reduction of body weight, BMI and abdominal circumference. Secondary objectives are reduction of bleeds and units coagulation factor concentrate used, blood-pressure, cholesterol spectrum, glucose and improvement of physical activity and dietary habits. one group of patients will receive a combined lifestyle intervention program with individual sessions and group sessions lasting for 2 years, the other group of patients will receive individual sessions only and will be given the same information as given in the group sessions, but on paper.

The prevalence of overweight and obesity is increasing in patients with hemophilia and other bleeding disorders. In these patients physical activity is often difficult due to arthropathy as a result of intra-articular bleeding in the past, with decreased joint movement and pain and the fear of new bleeds. This enhances weight gain, increases pressure on joints, leading to more bleeds and more arthropathy. In the long term overweight and obesity increases risk of cardiovascular diseases, with the concomitant need for anticoagulant therapy, which further enhances the bleeding risk in these patients. The aim of this exploratory study is to compare the effect of a lifestyle intervention program consisting of combined individual coaching and group sessions (CLI) with a lifestyle intervention program with individual coaching only (II).The program is especially designed for patients with a bleeding disorder. The investigators hypothesize that body weight, BMI, abdominal circumference, bleeds and units coagulation factor concentrate, as these are dosed on body weight, will decrease in both groups, but more in the CLI with group sessions.

Eligibility Criteria:
Inclusion criteria

* Diagnosed with hemophilia A, B, FVII deficiency, fibrinogen deficiency, von Willebrand Disease or other bleeding disorder preferably requiring coagulation products for prophylaxis or on demand in case of bleeding
* ≥ 18 years of age
* BMI ≥ 30 kg/m2
* Motivated to change their lifestyle
* Being able to speak, read and understand the Dutch language

Exclusion criteria

* Health care insurance with CZ or ONVZ as these health insurances have no contract with Profitt Lifestylecoaching.
* A contraindication or inability for physical activity as judged by the treating hemophilia physician
* Participation in another research trial
* Unable to understand the written information
* Unable to sign the informed consent
* Unwilling to randomize to the combined or individual intervention group