cyrilzakka/clinical-trials huggingface dataset:
Using Neuroimaging to Investigate Major Depressive Disorder

The purpose of this neuroimaging study is to investigate the brain correlates of Major Depressive Disorder with anxiety symptoms as well as potentially identify predictors of treatment outcome.

The purpose of this study is to test whether the structural and functional connectivity between the dorso-lateral prefrontal cortex (DLPFC) and amygdala will decline as symptoms of co-morbid anxiety (Anxiety Factor Score) increase in patients with MDD. This decrease in connectivity will also account for decrease in treatment response. The structural connectivity will be assessed using Diffusion Tensor Imaging (DTI) and the functional connectivity will be assessed using resting state BOLD fMRI.We propose to use the fMRI and DTI to identify biological markers that are associated with treatment response in a cohort of patients with a spectrum of Anxiety Factor Scores.

Eligibility Criteria:
Inclusion Criteria:

* Competent to give informed consent
* Diagnosis of Major Depressive Disorder
* Males and females
* Ages 18-50 years old
* All races and ethnicities
* Able to read, speak, and understand English\*

Exclusion Criteria:

* History of psychiatric illness except Major Depressive Disorder, Generalized Anxiety Disorder, Social Phobia, or Specific Phobia
* Alcohol or substance abuse within the last 6 months or alcohol or substance dependence within the last year
* Diagnosis of an organic brain disease
* Serious unstable medical illness
* History of serious head injury
* Unsafe or unable to have an MRI or previous inability to tolerate MRI
* Pregnancy or breast feeding
Validation of a Specific Measure for Assessment of Compliance With Treatment in Patients With Hemophilia

Research project for validation of a questionnaire on compliance to treatment in patients with hemophilia. It is intended to validate the American VERITAS-PRO scale according to the international methodology validation questionnaires: reverse translation, according to intersubject patients, psychometric validation and reliability analysis with large sample of patients.

The validated questionnaire obtained in this project will identify the actual degree of patient compliance to drug therapy, using as gold standard the difference between the treatment prescribed and administered.

Eligibility Criteria:
Inclusion Criteria:

* Patients with hemophilia A and B
* Patients who have previously signed the informed consent document

Exclusion Criteria:

* Patients with other congenital coaghulopatías (eg, Von Willebrand's disease)
* Patients with cognitive impairment, or oral or written understanding
Nutritional Assesment in Patients With Cirrhosis

This study aims to evaluated nutritional status in patiets with cirrhosis


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* age \>18, \<75 years old
* hepatic cirrhosis diagnosis

Exclusion Criteria:

* refuse to participate/to give consent
* presence of musculo-skeletal disease previous diagnosed, neuropathic diseases, malignancy
NIR Fluorescence Imaging Technique in Thoracic Surgery With ICG

This study aims to first apply near-infrared fluorescence imaging technology in thoracic surgery with indocyanine green in China. To evaluate the feasibility usage of the investigators' fluorescence imaging systems and the safety applications in intraoperative sentinel lymph node mapping of lung and esophageal cancer, lung nodule imaging, lung segment resection boundary determination, esophagus - tubular anastomosis, thoracic duct imaging and chylothorax repairing thoracic surgery. Aim to achieve precise boundaries definition during thoracic surgery and realize accurate, minimally invasive thoracic surgery with fluorescence imaging technology.

Lung cancer is a major threat to human health. Diagnosis and treatment using precision medicine is expected to be an effective method for preventing the initiation and progression of cancer. Although anatomical and functional imaging techniques such as radiography, computed tomography (CT), magnetic resonance imaging (MRI) and positron emission tomography (PET) have played an important role for accurate preoperative diagnostics, for the most part these techniques cannot be applied intraoperatively. Optical molecular imaging is a promising technique that provides a high degree of sensitivity and specificity in tumor margin detection. Furthermore, existing clinical applications have proven that optical molecular imaging is a powerful intraoperative tool for guiding surgeons performing precision procedures, thus enabling radical resection and improved survival rates. However, detection depth limitation exists in optical molecular imaging methods and further breakthroughs from optical open surgery to minimally invasive intraoperative imaging methods are needed to develop more extensive and comprehensive intraoperative applications.

Eligibility Criteria:
Inclusion Criteria:

* Pulmonary nodules undergoing thoracoscopy or thoracotomy
* Esophageal cancer patients who underwent radical surgery
* Preoperative liver function is normal
* No indocyanine green and iodine allergies, and indocyanine green skin test negative
* Volunteered to participate in this study and signed informed consent in this study

Exclusion Criteria:

* Preoperative liver dysfunction
* Indocyanine green or iodine allergies, or indocyanine green skin test positive
* Not combined with other well-controlled comorbidities
* Clinicians considered unsuitable for enrollment
Uncertainty in HFrEF Patients

This study was planned as a descriptive and correlational type study to reveal the effect of perceived uncertainty by heart failure (HF) patients with reduced ejection fraction on quality of life and self-care behaviors. In this study, which aimed to reach 122 inpatients with HF, the dependent variables were quality of life and self-care behaviors, the independent variable will be perceived uncertainty. Data will be collected by Mishel Uncertainty in Illness Scale-Community Form (MUIS-C), Left Ventricular Disfunction Scale (LVD-36) and European Heart Failure Self-Care Behavior Scale (EHFSeBS). Data analysis will basically be done with Multivariate Analysis of Variance (MANOVA).

This study aims to reveal the effect of perceived uncertainty on quality of life and self-care behaviors in HF patients with reduced ejection fraction. This descriptive and correlational study will include 122 HF patients hospitalized in the cardiology department of a university hospital in northern Turkey. The sample size was calculated according to parameters based on the power of 90%, 95% confidence interval, error level of 0.05, effect size of 0.59. Data will be collected by Mishel Uncertainty in Illness Scale-Community Form (MUIS-C), Left Ventricular Disfunction Scale (LVD-36) and European Heart Failure Self-Care Behavior Scale (EHFSeBS). Data analysis will basically be done with Multivariate Analysis of Variance (MANOVA).

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older,
* Having been diagnosed with heart failure by a physician for more than 6 months,
* Left ventricular ejection fraction \<40% as measured by echocardiography,
* Volunteering in participating in the study

Exclusion Criteria:

* Being under antidepressant treatment,
* Presence of a pre-existing psychiatric illness or cognitive impairment,
* Diagnosed with cancer and being under treatment related to cancer,
* Presence of chronic obstructive pulmonary disease.
A Study of ELX-02 in Patients With Alport Syndrome

This is a Phase 2 open label pilot study to evaluate the safety and efficacy of subcutaneously administered ELX-02 in patients with X-linked or autosomal recessive Alport Syndrome with Col4A5 and Col4A3/4 nonsense mutation.

In total, up to 8 participants, with a minimum of 3 adults, will be enrolled in the trial.

The study will be comprised of the following periods for each participant:

* a Screening period of up to 6 weeks (42 days)
* a total Treatment Period of 8 weeks (60 days)
* a safety/efficacy Follow-up Period of 12 weeks (90 days) after the last treatment The Treatment Period will be a treatment of ELX-02 0.75 mg/kg SC QD for 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* A confirmed diagnosis of X-linked or autosomal recessive Alport Syndrome with a documented nonsense mutation of Col4A5 in a male or nonsense mutation of Col4A3 or Col4A4 (male or female)
* The nonsense mutation should be UAG or UGA
* eGFR\>60 ml/min/1.73 m2 (based on CKD-EPI for ages ≥18 and Schwartz formula for participants \<18)
* Urinary protein based on two spot urine collections \[urine protein/creatinine ratio (UPCR) ≥ 500 mg/g\]
* Stable regimen of ACEi/ARB for at least 4 weeks before screening (unless there is a contraindication)

Exclusion Criteria:

* History of any organ transplantation
* Mutation consistent with autosomal dominant Alport Syndrome
* Liver disease characterized by cirrhosis or portal hypertension. Participants with alanine aminotransferase (ALT), aspartate aminotransferase (AST), and/or a total bilirubin 3.0 times the upper limit of normal (ULN) will be excluded
* History of congestive heart failure diagnosed clinically or with documented left ventricular ejection fraction (LVEF) ≤ 40%
* History of dialysis
A Survey on Blood Transfusions in Major Artrhoplasty Operations

The rate of hip, knee arthroplasties and their revision are increasing every year. The incidence of blood transfusion in these operations are reported 18%, 68%, and 39%, 67%, respectively. Blood transfusion is known to increase the risk of pulmonary, septic, wound and thromboembolic complications and is related to mortality. Restrictive transfusion protocols has cost-effective results in terms of reducing these complications, promoting early discharge and reduced frequency of re-admission.

Within this context, we aimed to evaluate the transfusion practice in our hospital, define the transfusion indicators and compare the transfused and non transfused patients in terms of recovery.

After obtaining ethical approval Patients undergoing hip or knee arthroplasty or revision arthroplasty will be included in this prospective observational study.

Patient characteristics (age , gender, body mass index, ASA physical status, anticoagulant medication) Preoperative: hemoglobin, hematocrit, platelet, INR, APTT, PT values, the precence of preoperative anemia, anemia treatment modalities will be recorded.

Intraopreative: type and duration of surgery, anesthesia method, monitoring methods used, the amount of intraoprative adminestred fluids (crystalloid-colloid), amount of hemorrhage Postoperative: hemoglobin-hematocrit-platelet leve The amount of blood transfusion and the product used (erythrocyte suspension, fresh frozen plasma, thrombocyte-fibrinogen-factor concentration-cryoprecipitate-other ) Hemoglobin-hematocrit-platelet level before and after transfusion Indications for transfusion; hemoglobin threshold / physiological transfusion indicator; tachycardia, hypotension, low flow rate, desaturation, low SvO2, inotropic requirement, etc. / comorbidities / monitorisation findings, other, Discharge time of patients Early upright position (postoperative 2nd day), information on walking capacities (TUG - The Time Up and Go test) will be recorded and compared between transfused and non-transfused patients

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing major atrhroplasty

Exclusion Criteria:

* Pediatric patients
A Study of Microcirculatory Function in Type 2 Myocardial Infarction (T2MI)

The purpose of this research is to find out if patients with Type 2 Myocardial Infarction (T2MI) without significant epicardial coronary artery disease (CAD) have a greater chance of having coronary microvascular disease (CMD).


Eligibility Criteria:
Inclusion Criteria:

* Ability to give informed consent
* Structurally normal heart (normal LV and RV function, no more than mild valvular heart disease)
* For controls: atypical chest pain with indication for CMD testing
* For T2MI: meet criteria for T2MI according to the 4th Universal definition of MI (rise/fall of troponin with at least 1 value \>99th centile+ evidence of symptoms or signs of myocardial ischemia)

Exclusion Criteria:

* Acute coronary event (evidence of plaque rupture, fissure or dissection on coronary angiogram)
* Known to have angiographically significant CAD/pressure wire positive for epicardial CAD
* Inability to receive heparin products
* Allergy/contraindication to acetylcholine/adenosine/nitroglycerine products
* Prior coronary artery bypass grafting
* Pregnancy (if sexually active woman of reproductive age, need negative pregnancy test prior to proceeding with coronary angiography - this is standard of care in cath lab)
* Asthma with prior ICU admission due to bronchospasm/need for invasive ventilation
A STudy of Upper Arm Rehabilitation in Stroke Survivors- ASTAR

This feasibility study will explore the clinical effectiveness of additional upper limb therapy compared to standard care delivered to Stroke Survivors at Sussex Rehabilitation Centre (SRC). Randomization via sealed envelope will allocate treatment group to either routine care or upper limb training for self-management plus routine care. If randomized to upper limb training, a patient will undertake 10 therapy sessions with an instructor from the Action for Rehabilitation for Neurological Injury (ARNI) program during their hospital stay. The last two ARNI-led sessions will be filmed by a nurse/carer on either their own tablet/phone or an i-pad. Participants in the ARNI group will be encouraged to continue doing their personalized exercises while in hospital and continued at home. The participants in the ARNI group will also be given a task-training board to take home.

This randomized controlled trial will measure outcomes of each group over six months. Each patient in the study will have upper limb physical measurements taken by a blinded Research Nurse (RN2) at baseline. Research Nurse (RN1) will gather data in a Clinical Report File from a weekly exercise diary completed by the patient or carer and well-being questionnaires. On discharge, RN2 will conduct upper limb measurements, collect completed hospital diaries and issue new ones to take4 home. RN1 will give a weekly phone call or text reminders so that patients to complete exercise diaries at home. At 6 months RN2 will do final measurements and complete patient questionnaires in an out patients clinic visit.

The investigators aim to recruit 36 patients and anticipate 30(8.3%) will complete the 6 month follow-up.

The study sponsor will be the University of Sussex. However, as the study is run in rehabilitation unit in an NHS hospital, University Hospitals Sussex NHS Trust will host the study.


Eligibility Criteria:
Inclusion Criteria:

* Stroke Survivors admitted to Sussex Rehabilitation Centre
* Aged 18 years or over
* Have an upper limb affected by stroke
* Have capacity to consent to participate in the study
* Medically stable

Exclusion Criteria:

* Aged under 18 years
* AMTS \<8
* Have a neurological deficit which does not involve upper limb
* Presence of a terminal illness with shortened life expectancy \<6 months.
Evaluation of Diabetic Foot Wound Healing Using Hydrogel/Nano Silver-based Dressing vs. Traditional Dressing

Background: The wound dressings perform a crucial role in the cutaneous wounds' management due to their ability to protect wounds and promote dermal and epidermal tissue regeneration. Objective: the aim of the present study to evaluate the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing.

Approach: Sixty patients with type-2 diabetes hospitalized for diabetic foot wound treatment were recruited from selected Surgical departments at Kasr Al-Aini university hospital.

Data Collection: The patients of group-I wounds were cleaned using normal saline; then, the wounds were closed firmly with hyderogel\\nano silver dressing. The dressing was changed every two days according to dressing manufacture instruction. When the dressing was opened after three days, the wound was assessed for granulation tissue, wound, and discharge size.

The patients of group II wounds were dresses using a traditional method, cleaned by normal saline, use of betadine antiseptic; then they were secured with clean linen gauze. The dressing was changed once daily. The wound healing process of the two groups was then assessed for three consecutive weeks.

Eligibility Criteria:
Inclusion Criteria:

Diabetes Type I and Type II patient with diabetic foot ulcer age ranged 35-55 years old Willing to participate

Exclusion Criteria:

unwilling to participate.
Efficacy of Ulinastatin for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma Patients

This is a phase 3, open-label, multicenter, randomized controlled phase III clinical trial. The purpose of this study is to evaluate the efficacy of ulinastatin, a kind of protease inhibitor, in the treatment of radiation-induced acute oral mucositis in localregionally advanced nasopharyngeal carcinoma(NPC) patients treated with concurrent chemoradiotherapy(CCRT). To Explore a new and efficient way to reduce the incidence and severity of radiation-induced acute oral mucositis.

Radiation-induced acute oral mucositis (RTOM) in Nasopharyngeal Carcinoma (NPC) patients treat with concurrent chemoradiotherapy (CCRT) is common. Currently, there is no effective treatment for RTOM. Ulinastatin, is a kind of natural anti-inflammatory substance. And this substance is insufficient when the body's inflammatory response is strongly. There are a series of studies have confirmed the efficacy and safety of ulinastatin in the treatment of body's inflammatory response. From the observation of our previous clinical practice, we found that ulinastatin can relieve the severity of RTOM. The present study is undertaken to evaluate the efficacy of ulinastatin in the treatment of RTOM in localregionally advanced NPC patients treated with CCRT.

Eligibility Criteria:
Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis
* Clinical stage III\~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition)
* Karnofsky Performance Status Scale between 80-100
* WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L
* ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
* Sign the informed consent.

Exclusion Criteria:

* Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
* Younger than 18 years old or older than 70 years old
* Pregnancy or lactation
* Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
* Have suffered from other tumor or now suffering from other tumor
* Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
* Refuse to give up smoking/drinking/betel chewing
* suffering from other active infection diseases and in need of treatment.
Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

This study proposes a novel stroke rehabilitation approach for upper extremity training by firstly combining different types of distal robot-assisted and task-oriented therapy in a circuit training program. The program could enhance UE functions, improving daily function, decrease caregiver burden and lower medical expenses associated with long-term care. Professionals can use these findings to promote the application of clinically empirical research and better understand the effects and mechanisms of circuit training.


Eligibility Criteria:
Inclusion Criteria:

1. unilateral stroke ≥ 3 months onset
2. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 18 to 56, indicating different levels of motor impairments ;
3. without excessive spasticity in any of the UE joint (modified Ashworth scale ≤3 in proximal joints and modified Ashworth scale ≤2 in distal joints);
4. Mini Mental State Exam (MMSE) score \> 24, indicating no serious cognitive impairment;
5. between the ages of 20 and 75 years -

Exclusion Criteria:

1. histories of other neurological diseases such as dementia, Parkinson's disease, and peripheral polyneuropathy;
2. difficulties in following and understanding instructions such as global aphasia;
3. enroll in other rehabilitation or drug studies simultaneously;
4. receiving Botulinum toxin injections within 3 months. -
Attain Performa™ Left Ventricular (LV) Quadripolar Leads Chronic Performance Study

Lead survivability will be summarized.

The purpose of this study is to evaluate long-term performance of the Attain Performa™ LV Leads. This evaluation is based on the number of lead-related complications occurring during the study compared to the number of leads enrolled in the study. The leads will be followed for 5 years after implant. This study is required by FDA as a condition of approval of the Attain Performa™ LV Leads. This study is conducted within Medtronic's post-market surveillance platform.

Eligibility Criteria:
Patients who meet all of the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment.

Inclusion Criteria

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient has or is intended to receive an Attain Performa™ LV lead
* Patient within 30 day post implant enrollment window

Exclusion Criteria

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
nCap Pain Relief Patch vs. Placebo

The purpose of this study is to determine whether use of the nCap Medical Nano-Capacitive pain relief patch reduces subject pain as measured by subject pain scores, WOMAC scores (pain, stiffness and physical function), global assessment scores, and pain medication change as compared to participants randomly assigned to the sham patch group.


Eligibility Criteria:
Inclusion Criteria:

* Meet Altman's clinical criteria for Knee Osteoarthritis
* Male and Female Adults age 40-79
* VAS pain score of \> 4 at the beginning of the study

Exclusion Criteria:

* Subject unable to walk unassisted. Participants must be able to stand/walk for 30 minutes
* Inability to read and understand English. Must be able to complete WOMAC scale and questionnaires
* Severe systemic disease limiting ability to ambulate for 30 minutes
* Use of a TENS unit for one week before study or during study
* History of total knee replacement on the affected knee
* Knee surgery on the affected knee in the last 12 months
* Injection into the knee in the last 6 months
* Knee pain \< 411
* Inability to cognitively understand consent form or research study, or inability to give consent
* Diagnosis of fibromyalgia, rheumatoid arthritis, gout, dysplasia, septic arthritis, knee pain from other diseases.
* Malignancy
* Injury to knee within 6 months
* Concomitant use of opioids, NSAIDS or other analgesics for 1 week before trial (or 5 half-lives, whichever is greater)9, or during trial with exception of acetaminophen.
* Pregnant or lactating
* Poor general health (ASA classification of IV+)