cyrilzakka/clinical-trials huggingface dataset:
Chronic Kidney Disease and Non-alcoholic Fatty Liver Diseases

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide. This disease reportedly affects up to 30% of the general population in Western countries, especially in patients with metabolic syndrome, obesity, and type II diabetes. NAFLD is considered to be an independent risk factor for cardiovascular disease and there is accumulating evidence to support a causative role in the development of chronic kidney disease (CKD). So, we aim first to assess the prevalence of chronic kidney disease in NAFLD patients, secondly to detect the association between hepatic fibrosis and CKD in NAFLD patients

This study will be conducted on 100 patients 70 patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital, and A control group of 30 healthy volunteers who looks normal on ultrasonography from February 2021 to July 2021.

Methods:

All included patients will be subjected to:

1. Detailed history, complete general and systemic examination .
2. BMI will be calculated as follow
3. Abdominal Ultrasonography.
4. Laboratory investigations:

   Fasting and post-prandial blood sugar Serum lipogram. Liver function tests. Serum creatinine, Albumin -creatinine Ratio.
5. Calculation of estimated Glomerular Filtration Rate eGFR.
6. Liver stiffness measurements to detect degree of fibrosis and measurement of the degree of steatosis using (Fibroscan)

Ethical considerations:

The study will be approved by The Ethical committee of Sohag Faculty of Medicine, Sohag University.

The study protocol will be adherent to practice guidelines of the World Medical Association Code of Ethics (Declaration of Helsinki).

After explanation about the nature of the procedures, possible complications, benefits, and steps of the study, All patients will give a written informed consent for participating in the study, performing abdominal ultrasound, taking blood samples, performing fibroscan.

Eligibility Criteria:
Inclusion Criteria:

patients diagnosed to has NAFLD by ultrasonography presented to the outpatient clinic of Sohag University Hospital

Exclusion Criteria:

1. Diabetic patients.
2. Hypertensive patients.
3. Other causes of chronic liver disease rather than NAFLD.
Integrated PTSD and Smoking Treatment

Research shows that people with PTSD are more likely to smoke than people without PTSD. It also shows that people with PTSD have more difficulty at attempts to quit smoking. This study is part of a program aimed at finding out how best to help smokers quit who also have PTSD. One option is to give patients standard smoking cessation treatment including nicotine replacement and cognitive behavioral therapy. Another option is to give patients the standard smoking cessation treatment in addition to treatment for their PTSD symptoms (called prolonged exposure). However, it is not known which method works better. In order to answer this question, patients will be assigned by chance to one of two groups. One group will be given standard smoking cessation treatment to help quit smoking. A second group will be given the standard smoking cessation intervention to help quit smoking in addition to a form of psychotherapy called Prolonged Exposure to reduce symptoms of PTSD. The patients will be randomly assigned (by chance) to one of these groups. If the patient is assigned to the smoking cessation only condition and the patient still has PTSD symptoms after the last study visit (week 30) the patient will be offered treatment for your PTSD symptoms (Prolonged Exposure) at no cost. The patient's participation will help the investigators determine if treating PTSD symptoms enhances the ability of standard smoking cessation to help people quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* You have PTSD
* You currently smoke more than 8 cigarettes per day
* You have a motivation to quit smoking
* You are between the age of 18 and 65.

Exclusion Criteria:

* You are currently using other tobacco products (other than cigarettes)
* You have any history of a suicide attempt, or are at significant risk of self-harm or harm to others
* You have severe depression
* You have any history of bipolar disorder, psychotic disorder
* You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months
* You are currently receiving other treatment specifically for PTSD or smoking cessation
* You are unable to read and speak English (as the materials are provided in English)
Impact of Near-Infrared Vein Mapping on Outcomes and Satisfaction After Botox/Filler Treatment

Researchers are studying how vein mapping impacts patient outcomes and satisfaction after facial injection procedures.

Facial Botox/filler injections carry risk of puncturing superficial veins, leading to bruising and pain. Our study will investigate the utility of non-invasive vein imaging (specifically near-infrared light reflection) on the incidence of pain/bruising/hematoma and patient satisfaction after facial injections.

The current standard of care for facial injection procedures does not involve any modality of facial venous mapping. Vein mapping is a non-invasive, simple task that takes very little time to conduct. One risk is patient time, however maximum extra time needed will be 5 minutes during the clinical visit. This potential extra time in mind, the benefits far outweigh the risks.

Two cohorts of patients will be prospectively compared following randomization, those who did have pre-procedure venous mapping prior to injection versus those who did not. Data will be analyzed with regard to bruising and swelling following injection, as well as other potential complications such as hematoma or infection, along with patient satisfaction survey information.

Eligibility Criteria:
Inclusion Criteria:

* Patients pursuing aesthetic/therapeutic facial injection procedures (botox/filler)

Exclusion Criteria:

* Patients undergoing aesthetic facial procedures not requiring needle injection
An Open-Label Preference Evaluation of BLI800

The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.

The objective of this study is to evaluate the patient satisfaction and preference of BLI800 in adult patients undergoing colonoscopy.

Eligibility Criteria:
Primary Inclusion Criteria:

* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication
* 18 to 85 years of age (inclusive)
* If female, and of child-bearing potential, is using an acceptable form of birth control
* Negative urine pregnancy test at screening, if applicable
* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Primary Exclusion Criteria:

* Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon
* Subjects with ongoing severe, acute inflammatory bowel disease
* Subjects who had previous significant gastrointestinal surgeries
* Subjects with known severe renal, hepatic or cardiac insufficiency
* Subjects undergoing insulin therapy for any indication
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration
* Subjects undergoing colonoscopy for foreign body removal and/or decompression
Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy

The aim of the present study is to evaluate whether the use of indocyanine green fluorescent cholangiography is responsible in a decrease of biliary fistula's rate in patients with liver diseases requiring liver resection.


Eligibility Criteria:
Inclusion Criteria:

* benin or malignant liver disease with resection of 2 or more segments
* liver resection by laparotomy
* written consent

Exclusion Criteria:

* previous hepatectomy
* emergency surgery
* allergy to indocyanine green
* allergy to methylene blue
* pregnancy or breastfeeding
REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy

This study is researching an experimental drug called REGN7257 (called "study drug"). The study is focused on patients who have severe aplastic anemia (SAA), a disease of the bone marrow resulting in an impairment of the production of blood cells.

The main purpose of this two-part study (Part A and Part B) is to test how safe and tolerable REGN7257 is in patients with SAA in which other Immunosuppressive therapies (ISTs) have not worked well.

The study is looking at several other research questions to better understand the following properties of REGN7257:

* Side effects that may be experienced by participants taking REGN7257
* How REGN7257 works in the body
* How much REGN7257 is present in blood after dosing
* If REGN7257 works to raise levels of certain blood counts after treatment
* How quickly REGN7257 works to raise levels of certain blood counts
* In patients for whom REGN7257 works to raise levels of certain blood counts after treatment, how many continue to show such a response throughout the study
* If REGN7257 works to lower the number of platelet and red blood cell transfusions needed
* How REGN7257 changes immune cell counts and composition
* How the body reacts to REGN7257 and if it produces proteins that bind to REGN7257 (this would be called the formation of anti-drug antibodies \[ADA\])


Eligibility Criteria:
Key Inclusion Criteria:

1. Part A: SAA that is IST-refractory or IST-relapsed, as defined in the protocol
2. Part B: SAA that is IST-relapsed, as defined in the protocol
3. Hematopoietic stem cell transplantation (HSCT) is not available or suitable as a treatment option or has been refused by the patient
4. Adequate hepatic and renal function as defined in the protocol

Key Exclusion Criteria:

1. Diagnosis of Fanconi anemia or other congenital bone marrow failure syndrome as defined in the protocol
2. Evidence of myelodysplastic syndrome as defined in the protocol
3. Paroxysmal nocturnal hemoglobinuria (PNH) with evidence of clinically significant hemolysis (eg, treatment indicated) or history of PNH-associated thrombosis
4. Treatment with a T cell-depleting agent (eg, ATG or alemtuzumab) within 6 months prior to dosing
5. Treatment with a calcineurin inhibitor (eg, cyclosporine) within 4 weeks prior to dosing for patients enrolled in Part A
6. Treatment with eltrombopag or investigational thrombopoietin receptor agonist, Granulocyte Colony-Stimulating Factor (G-CSF), or an androgen (eg, danazol), within 2 weeks prior to dosing
7. HIV, hepatitis B or hepatitis C positive by serological testing at the screening visit as defined in the protocol
8. Active tuberculosis, latent tuberculosis infection (LTBI) or history incompletely-treated tuberculosis or LTBI
9. Active infection as defined in the protocol

Note: Other protocol-defined inclusion/ exclusion criteria apply
VR for Patients With Chronic Pain (Wait & Work)

This cluster-RCT evaluates the effect of therapeutic virtual reality (VR) on patients with chronic musculoskeletal pain (CMP) who are on a waiting list to receive pain treatment. The used VR application, Reducept, offers pain education and pain management techniques. This home-based, stand-alone, immersive VR intervention was used daily for four weeks in the intervention group. The control group received standard care (no treatment). Primary outcome measure for this study was health-related quality of life, secondary outcome measures included various pain-related variables (e.g. pain self-efficacy and acceptance. Outcome variables will be measured after four weeks and follow-up after six months.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* suffering from primary or secondary CMP
* finished with biomedical diagnostics and treatment
* open to biopsychosocial treatment
* willing and capable of complying with study procedures.

Exclusion Criteria:

* not able to finish the VR intervention due to physical (e.g. visual impairment), mental (e.g. severe sensitivity to stimuli) or practical problems (e.g. insufficient tech-literacy)
* unable to finish Dutch questionnaires.
LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus

The rationale of the study is to determine:

* the first dose and the titration of basal insulin
* the exact daily time administration of basal insulin in poorly controlled type II diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
* BMI \>25 kg/m2 , \<30 kg/m2
* HbA1c value \>7.0%, \<9.0% within one month

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* Known malignancy
* Drug or alcohol abuse
* Severe liver disease
* Renal failure (se Creatinine \> 150 micro mol/l)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Comparison Between the Effectiveness of Wii Fit Plus and Core Exercise Program in Improving Core Stability in Adults

This study will compare the effectiveness of core stability and Wii fit plus exercise in improving core stability. Group A will perform Wii fit plus exercises and group B will perform core stability exercise.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 29 years
* Male and female subjects
* Trunk flexor endurance less than 144 seconds in male and 149 seconds in female subjects
* Trunk extensor endurance less than 146 seconds in male and 189 seconds in female subjects
* Flexibility less than 24 cm in male and 27 cm in female.

Exclusion Criteria:

* Weight more than or equal to 150 kg because it is the maximum limit for balance board
* Spinal surgery history,
* Current low back pain
* Performing exercise in routine
* Acute or chronic cardiovascular disease
* Acute or chronic musculoskeletal disease
* Acute or chronic neurological disease.
Two-year Follow-up of a Mindfulness-based Intervention in Children.

The primary aim of this study was to determine whether an 8-week mindfulness-based intervention, called Training for Mindfulness and Resilience (TMR), mitigates moderate mental health symptoms and increases resilience during a 2-year follow-up.

Methods

The participants were 34 schoolchildren in age range of 9-14 years, reporting moderate mental health problems. Participants were randomised into either TMR intervention group (N=22) or control group, receiving best current practice (N=12). The investigators used validated self-rating questionnaires to measure anxiety, depression, anger, disruptive behaviour, self-concept, resilience, stress and mindfulness before treatment with either TMR or control, as well as at 6 months, 1 year and 2 years after treatment period.


Eligibility Criteria:
Inclusion Criteria:

* F32.0 Mild depressive episode
* F32.1 Moderate depressive episode
* F41 Anxiety disorders
* F43 Reactions to stress
* F51 Nonorganic sleep disorders
* F93 Emotional disorders with onset specific to childhood
* F94.8 Other childhood disorders of social functioning
* F94.9 Other childhood disorder of social functioning, unspecified

Exclusion Criteria:

* Ongoing treatment for severe psychiatric disorders (F20-29, F31-F33.3)
* Cognitive disorders
* Difficulties in understanding Swedish
* Neuropsychiatric considerations and diagnosis
* Learning disabilities with difficulties in verbal understanding
* Ongoing parental conflict in conjunction with separation/divorce.
* Attending less than 5 of the 8 sessions of the TMR program.
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee

A multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of patients with osteoarthritis of the knee


Eligibility Criteria:
Inclusion Criteria:

* both male and female who is over 35year-old and below 80year-old
* patient who diagnosed as Kellgren \& Lawrence stage I\~III by X-ray
* osteoarthritis patient who is stable within 3months form starting this clinical trial
* patient who is over 40mm in 100mm Pain VAS at Visit 2
* patient who agreed to participate this clinical trial spontaneously

Exclusion Criteria:

* second osteoarthritis
* patient who has inflammatory disease which can effect efficacy outcomes such as bursitis, tenosynovitis, rheumatoid arthritis, etc.
* patient who diagnosed as gastric ulcer or GI disease by esophagogastroduodenoscopy
* patient who had joint surgery within 12months form screening visit of this clinical trial or planned to operate in this clinical trial period
* patient who has had artificial joint surgery of knee
* malignant tumor patient
* patient who has taken Psychopharmaceutical or Narcotic Analgesics over 3months continuously
* patient who took steroid by oral, inhalation or intraarticular injection within 3months form screening visit of this clinical trial
* patient who took intraarticular hyaluronic acid injection of knee within 2months form screening visit of this clinical trial
* patient who cannot take NSAIDs because of disease or medicine
* allergy of aspirin of other NSAIDs
* patient who has to handle his/her pain by or for CABG
* galactose intolerance, Lactose Intolerance or glucose-galactose malabsorption
* inflammatory bowel disease such as ulcerative colitis or Crohn's disease
* moderate renal disease
* moderate hepatic disease
* moderate hypertension(SBP=\>160mmHg, DBP=\>100mmHg)
* female who consents to contracept
* patient who is not appropriate for this clinical trial
Trans-thoracic Ultrasound VS Invasive Pressure of the Left Atrium

As part of cardiac and hemodynamic evaluation of patients, echocardiographic measurements allow indirect evaluation of left ventricular filling pressures (LVFP). These ultrasound parameters, including mitral valve doppler and mitral ring doppler (in particular the E / E 'ratio), are well validated in medical cardiology and in some resuscitation patients. The measurement of filling pressures is an important daily element in the medical management of patients in intensive care, in particular on the hemodynamic and respiratory levels. No studies have evaluated the relevance of these markers in a postoperative context of cardiac surgery. Indeed, the surgery alters the cardiac function, which could modify the values of the echocardiographic parameters and their predictability. Left atrium pressure (LAP) directly reflects LVFP and is measured in cardiac surgical resuscitation by a surgically placed catheter as part of routine institutional care and will serve as gold-standard. To study the clinical significance of these LAP and LVFP values estimated by cardiac ultrasound, we will study their correlation with clinical and ultrasound signs of acute lung edema (ALE).


Eligibility Criteria:
Inclusion Criteria:

* Patient hospitalized in surgical resuscitation for cardiac surgery with heart-lung bypass machine

Exclusion Criteria:

* No consent
* Mitral valve surgery
* severe MI / severe mitral narrowing.
* Absence of POG catheter
* Urgent surgery
* Heart transplant / mechanical assistance
* Classics: minors, pregnant women, guardianship / curatorship / safeguarding,
INITIATE Plus (INITiation of Insulin to Reach A1c TargEt) Study

This trial is conducted in the United States of America (USA). The purpose of this study is to compare the effectiveness and safety of a biphasic insulin aspart standard titration regimen when coupled with dietary intervention to standard titration without dietary intervention.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
Expanded Access to Venetoclax

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to Venetoclax prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

* The participant must not be eligible for a venetoclax clinical trial.
* Pediatric participants may be evaluated on a case by case basis.
Blockade of Vascular Potassium Channels During Human Endotoxemia

Background: Activation of NO-synthase and vascular potassium (K) channels may play a role in the sepsis-induced attenuated sensitivity to norepinephrine. We examined whether various K channel blockers and NO-synthase inhibition could restore norepinephrine sensitivity during experimental human endotoxemia.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* drug, alcohol, nicotine abuse
Deep NMB in Ambulatory Gynecological Laparoscopy

Gynecological laparoscopic surgery is commonly performed as an ambulatory basis for the aim of rapid discharge, reduce hospital stay with reduced costs and to improve postoperative QOR \[1,2\]. However, the creation of pneumoperitoneum during laparoscopy may cause postoperative pain and other physiological changes \[3\], which could influence the postoperative QOR negatively \[4\]. Poor postoperative QOR leads to prolonged hospital stay \[5\].

Deep NMB is known to improve surgical conditions and pneumoperitoneium related complications in laparoscopic surgery \[6,7,8,9\]. However, it is unknown whether deep NMB improves postoperative QOR in ambulatory gynecological laparoscopy.

Therefore, we designed a double blind randomised trial to compare the effects of deep and moderate NMB on postoperative QOR in ambulatory gynecological laparoscopic surgery. We hypothesized that deep NMB improves postoperative QOR, compared to moderate NMB. The primary outcome was postoperative QOR in POD1. The secondary outcome was quality of surgical conditions, pain scores, time to meet PACU and hospital discharge, and opioid consumption

Eligibility Criteria:
Inclusion Criteria:

* ASA I and II

Exclusion Criteria:

* Neuromuscular disorders