cyrilzakka/clinical-trials huggingface dataset:
Link Between Biochemical, Anthropometric Variables and CD36 in Metabolic Syndrome After a Low-calorie Diet

This study evaluated the effects of a weight loss diet on biochemical, anthropometric variables, and cluster of differentiation 36 (CD36) levels in 65 patients newly diagnosed with metabolic syndrome (MetS). Participants followed an 8-week medical nutrition therapy (MNT) designed to achieve at least 5% weight loss. Significant changes were observed in some biochemical parameters and blood pressure among those who adhered to the diet. CD36 levels showed correlations with various metabolic and body composition parameters.

This research aimed to assess the impact of a weight loss diet on biochemical and anthropometric variables, as well as CD36 levels, in 80 patients newly diagnosed with metabolic syndrome (MetS) who began a weight loss program. The study was completed all of whom were diagnosed with MetS and had applied to the Internal Medicine Outpatient Clinic at Ordu University Training and Research Hospital. At the start of the study, participants were provided with medical nutrition therapy (MNT) tailored to their energy and nutritional needs, as well as their lifestyle, with the goal of achieving at least a 5% weight loss within 8 weeks. Patients were monitored regularly throughout the process.

Before initiating MNT, participants' general characteristics and dietary habits were collected through face-to-face interviews. Additionally, 24-hour dietary recalls and anthropometric measurements were taken both before and at the end of the 8th week. Biochemical data were retrieved from patient records, blood pressure was measured by a physician, and fasting blood samples were collected for CD36 analysis, which were then stored at -80°C until further examination.

By the end of the study, some individuals adhered strictly to the MNT. Statistical differences were observed in some biochemical parameters and blood pressure between those who complied with MNT and those who did not. Correlations were observed between CD36 levels and some variables.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 19-64
* Being diagnosed with MetS by a physician according to the International Diabetes Federation (IDF)-2005 metabolic syndrome diagnostic criteria
* Being a volunteer to participate in the study

Exclusion Criteria:

* Being pregnant and breastfeeding
* Smoking and drinking alcohol
* Having any chronic disease other than metabolic syndrome
* Taking regular medication
* Taking regular nutritional supplements
* Having a change in weight within the last 3 months
Study to Characterize Effects of Programming in SCS Patients Undergoing a Temporary Trial

This is a prospective, multi-center, non-randomized, exploratory, single-arm study characterize the effects of programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial


Eligibility Criteria:
Key Inclusion Criteria:

* Study candidate is undergoing a spinal cord stimulation (SCS) trial of BSC neurostimulation system, per local directions for use (DFU).
* Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
* Subject is 18 years of age or older when written informed consent is obtained.

Key Exclusion Criteria:

* Subject meets any contraindication in BSC neurostimulation system local directions for use (DFU).
Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery

The goal of this clinical trial is to learn if continuous glucose monitoring works to treat postprandial hypoglycaemia in patients who have undergone gastric bypass surgery. The main question it aims to answer is:

• Is continuous glucose monitoring superior to usual care for prevention of postprandial hypoglycaemia in patients with verified postprandial hypoglycaemia after gastric bypass surgery?

Researchers will compare continuous glucose monitoring to usual care to see if continuous glucose monitoring works to treat postprandial hypoglycaemia.

Participants will:

* Use a continuous glucose monitor for 6 weeks or use no continuous glucose monitor for 5 weeks and wear a blinded continuous glucose monitor for 1 week.
* Visit the clinic 2-3 times and have 2-3 phone consultations.
* Register symptoms of hypoglycaemia, answer questionnaires, undergo a 24-hour dietary recall interview conducted by a registered dietitian, measure weight and body composition and take blood samples.


Eligibility Criteria:
Inclusion Criteria:

* Gastric bypass surgery at least 1 year ago
* Age ≥18 years
* Symptomatic postprandial hypoglycaemia; capillary glucose level \<3.0 mmol/L 1-4 hours after meals

Exclusion Criteria:

* Not able to give informed consent
* Reduced compliance due to severe mental and psychiatric conditions
* Use of insulin or sulfonylureas
* Use of systemic corticosteroids
* Primary or secondary adrenal insufficiency
* Insulinoma
* Severe heart-, lung, liver- or kidney disease, cancer, malnutrition and other medical conditions causing fragility
* Performed bariatric revisional surgery
* Drug- or alcohol abuse
* Pregnancy
* Use of acarbose or octreotide in the treatment of postprandial hypoglycemia
* Use of continuous glucose monitor
A Study of ARRY-438162 in Patients With Rheumatoid Arthritis

This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-438162 in treating rheumatoid arthritis in patients on stable doses of methotrexate, and to further evaluate the safety of the study drug. Approximately 200 patients from the US, Argentina, Brazil, Hungary, Peru, Poland and Romania will be enrolled in this study.


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of rheumatoid arthritis, based on the American College of Rheumatology (ACR) 1987 Revised Criteria, prior to first dose of study drug.
* Patient has received a stable dose of methotrexate for ≥ 6 weeks prior to first dose of study drug and is willing to continue on this regimen for the duration of the study.
* Patient has received a stable dose of folate for ≥ 6 weeks and is willing to continue on this regimen for the duration of the study.
* No prior use of biological agents for the treatment of rheumatoid arthritis.
* Additional criteria exist.

Key Exclusion Criteria:

* Diagnosis of any other inflammatory or non-inflammatory arthritis that may interfere with disease activity assessments or clinically apparent osteoarthritis which would affect subsequent efficacy measures.
* A history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological disease or severe systemic involvement with rheumatoid arthritis.
* Additional criteria exist.
Preoperative Nutritional Support in Esophagectomy or Pancreaticoduodenectomy

We are proposing to evaluate the benefit of preoperative nutritional support with Impact Advanced Recovery in the most vulnerable group of elective gastrointestinal surgery patients who may experience a complication, esophagus and pancreas resections, and hypothesize that oral supplementation with 3 servings (0.75 L) Impact Advanced Recovery will reduce postoperative stay by 10-20% and reduce the incidence of major complications by 25%.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female age 18 years or older of any race-ethnicity who will undergo an elective esophagectomy or pancreaticoduodenectomy.
2. Surgery will be scheduled 5-7 days after consent date -

Exclusion Criteria:

1. Surgery is urgent or emergent and/or patient would be unable to consume nutritional supplement for 5-7 days
2. Patient is currently receiving enteral (tube) or parenteral (IV) nutritional support
3. Patients with known pre-existing renal failure requiring a low protein diet
4. Patient is unable to drink 3 servings/day of a liquid supplement -
Prevention of Infections in Cardiac Surgery (PICS): a Cluster-randomized Factorial Cross-over Trial

The goal of this pragmatic, multi-centre factorial cluster randomized cross-over trial is to assess the efficacy of a combination of cefazolin plus vancomycin compared to cefazolin monotherapy, as well as a comparison of short versus long-term prophylaxis with four study arms: 1) cefazolin short-term, 2) cefazolin long-term, 3) cefazolin plus vancomycin short-term and 4) cefazolin plus vancomycin long-term.

Although antibiotic prophylaxis is considered the cornerstone of prevention for sternal surgical site infections (s-SSIs), the most effective antimicrobial regimen and optimal duration remain unclear. There is a pressing need to determine how best to prevent sternal surgical site infections and at the same time reduce adverse events from unnecessary antibiotic exposure. Currently, due to the lack of evidence, unproven approaches prevail and adherence to guidelines is poor. Rigorous randomized controlled trials data are needed for improved patient care.

A factorial cluster randomized cross-over trial, a design not used previously in this field, will address these gaps. To date, we have successfully enrolled close to 6,000 eligible patients in the vanguard study, and have shown that the trial as planned is feasible and operationally highly cost-effective.

Eligibility Criteria:
Inclusion Criteria:

Adult patients (≥18 years of age) undergoing open-heart surgery (i.e. sternotomy, including minimally-invasive surgical techniques through mini-sternotomies)

Exclusion Criteria:

1. On systemic antibiotics or with an active bacterial infection at the time of surgery
2. Previously enrolled in this trial
3. Known to be colonized with methicillin-resistant staphylococcus aureus (MRSA). Where it is unethical to not administer glycopeptides.
4. Beta-lactam or vancomycin allergy precluding the use of cefazolin or vancomycin, respectively
5. Participation in other studies that may interfere with this trial.
6. Patients undergoing cardiac transplant
Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients

Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study duration 52 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Patients who had had curative resection for histologically confirmed Stage I, II, or III gastric carcinoma or carcinoma of the oesophagogastric junciton.
* Male or female patients over 18 years of age.
* Patients with a life expectancy of at least four months.
* Karnofsky index for performance status of \>70%
* Patients must have given written informed consent.

Exclusion Criteria:

* Gastric or junctional surgery within three weeks of baseline (week 0) or gastric or junctional surgery anticipated in the study period.
* History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix.
* Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of chemotherapy or immunotherapy.
* Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of radiotherapy or any other anti-cancer therapy.
* Previous use (within the four weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of immunosuppressants, including systemic corticosteroids.
* Known immunodeficiency.
* Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration.
* Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or up to week 16 during this study.
* Previous G17DT treatment.
* Haematological indicators:

Haemoglobin \<10.0g/dl Neutrophils \< 2.0 x 109/l Platelets \<100 x 109/l
FIRST-Oslo Long-term Follow-up

The study aims to describe the functional level of the patients who received high intensity gait training during inpatient stroke rehabilitation at discharge, three, six and twelve months after stroke. These data will determine if the observed gains from the high-intensity gait training are retained after discharge from inpatient rehabilitation.

The study is a cohort-study that will have a prospective observational design. This design allows us to follow patients who presently have had a stroke and received high intensity stepping training over time. At this time little is known about the patient's functional trajectory the first 12 months after receiving high intensity stepping treatment as no study has examined long-term effects of high-intensity stepping training delivered in inpatient rehabilitation for stroke in Norway nor internationally.

Eligibility Criteria:
Inclusion Criteria:

* Adults (\>18 years old) who are receiving inpatient rehabilitation for stroke
* \< six months post-stroke
* have the goal to improve walking function
* provide written consent will participate in the study.

Exclusion Criteria:

* inability to consent
* use of bracing or instrumentation (e.g. ventilator) that limits walking
* independence in walking outdoors and on stairs (Functional Ambulation Category (FAC) at admission = 5)
* uncontrolled cardiopulmonary, metabolic, infectious or psychiatric disorders
Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy

Patients who have doubt for ectopic pregnancy will be enrolled for our study. These patients will be determined with using irregular increased human chorionic gonadotropin (beta-HCG) results and no embryo reported ultrasonography results. Plasma and cervical fluid samples will be taken from these patients and axonemal dynein heavy chain 5 and creatine kinase levels of samples will be compared between patients who have doubt for ectopic pregnancy and patients who have intrauterine pregnancy. Concentration of these proteins in samples will be evaluated. If any difference will be found between groups in favour of ectopic pregnancy, these results might be interpreted as these proteins useful for early detecting of the ectopic pregnancy.


Eligibility Criteria:
Inclusion Criteria:

* Doubted ectopic pregnancy
* Without any finding about intrauterine pregnancy in ultrasonography results
* Without any vaginal bleeding
* Having irregular pregnancy test results
* Beta-HCG results should be at least upper than 100 milli-International unit (mIU/ml)
* Having fist trimester pregnancy for intrauterine pregnancy group
* Without any emergency findings

Exclusion Criteria:

* Doubted incomplete abortion
* Having vaginal bleeding
* Having ultrasound results which include intrauterine embryo report
* Having lower than 100 mIU/ml beta-HCG results
* Without fetal heart rate in intrauterine pregnancy group
* Having older than fist trimester pregnancy for intrauterine pregnancy group
* Having emergency findings
Navigated EM Total Knee Replacement: Accuracy Study

The use of computer-assisted surgery by orthopedic surgeons experienced in the performance of total knee arthroplasty may result in better overall limb and implant alignment and fewer outliers as compared with the findings after manual total knee arthroplasty.

The alignment results in previous studies were based on radiographic measurements. The sensitivity of radiographic assessment of limb and implant alignment may not be significant enough to distinguish small differences between computer-assisted surgery and manual techniques.

It is possible that alignment differences that were too minor to be exposed on standard radiographs might result in long-term differences in the durability of arthroplasties performed with use of computer-assisted surgery or manual techniques.

Moreover it is possible to measure additional implant positioning parameters with computed tomography (CT) technology.

In this study, the investigators would like to add new method, for accurate measurement of implant alignment and to correlate its results with clinical data.


Eligibility Criteria:
Inclusion Criteria:

* Signing informed consent

Exclusion Criteria:

* Pregnancy
* Soldiers in active military service
Observation and Prediction of Complications After Coronary Angiography

Coronary angiography via the femoral artery is regarded as a safe procedure, but bleeding complications are often seen. To avoid/reduce bleeding complications digital compression is applied in the area of puncture during approximately 20 minutes and the patient is in the investigators' department observed in bed for 2 hours. The investigators apply pressure over the puncture site using a sand bag in the first hour. The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours (standard observation). In the present study the patients are randomized between standard observation and an alternative observation, where the patients are allowed to lift their head, arms and legs during the 2 hours, otherwise as standard observation.

The study has three aims:

1. To establish the incidence of bleeding complications:

   * Frequency of hematoma (\> 5 cm)
   * Frequency of pseudoaneurysms
   * Frequency of bleeding demanding surgery
   * Frequency of bleeding demanding transfusion
2. Establish a model to predict in wich patient to expect a bleeding complication.
3. Assess if the alternative observation is associated with more bleeding complications compared to standard observation.


Eligibility Criteria:
Inclusion Criteria:

1. Coronary angiography by the femoral access, where the arterial lumen is reached.
2. Only attempted puncture at one side.
3. Age \>= 18 years.

Exclusion Criteria:

1. Conditions that makes observation in the department impossible.
2. Dementia or other reasons to expect lack of compliance.
3. Previous participation in the project.
4. Implanted vascular prothesis at puncture site.
Pharmacokinetic and Safety Study of Travoprost 0.004% in Pediatric Glaucoma Patients

The purpose of this study was to assess the safety and describe the steady-state plasma pharmacokinetic (PK) profiles of Travoprost ophthalmic solution, 0.004% (new formulation) following a once daily administration for 7 days in pediatric glaucoma or ocular hypertension patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of glaucoma or ocular hypertension in at least 1 eye.
* Parent/legal guardian must provide informed consent, and children must agree to sign an approved assent form when applicable.
* Must agree to comply with the requirements of the study and must be accompanied by a parent/guardian.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential that are currently pregnant, have a positive result on a pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast feeding, or are not using birth control measures.
* One sighted eye or monocular, including patients who cannot be dosed in both eyes for any reason.
* History of chronic, recurrent or severe inflammatory eye disease.
* Ocular trauma requiring medical attention within the past 3 months prior to the Screening Visit.
* Ocular infection or ocular inflammation within the past 30 days prior to the Screening Visit.
* Clinically significant or progressive retinal disease such as retinal degeneration, diabetic retinopathy, or retinal detachment.
* Other severe ocular pathology (including severe dry eye), that in the opinion of the Investigator, would preclude the administration of a topical prostaglandin analogue.
* Intraocular surgery within the past 30 days prior to the Screening Visit.
* Any abnormality preventing reliable tonometry.
* Any other conditions including severe illness which would make the patient, in the opinion of the Investigator, unsuitable for the study.
* Hypersensitivity to prostaglandin analogues or to any component of the study medications in the opinion of the Investigator.
* Therapy with another investigational agent or device within 30 days prior to the Screening Visit.
* Body weight \< 5kg.
* Other protocol-defined exclusion criteria may apply.
EndoMaster EASE System for Treatment of Colorectal Lesions

This is a prospective, single arm study to assess the safety and performance of the EndoMaster EASE (Endoluminal Access Surgical Efficacy) System for the treatment of patients with colorectal neoplasms.

Prospective, single arm study to assess the safety and performance of robotically assisted ESD of superficial colorectal lesions, that otherwise cannot be optimally and radically removed by snare-based techniques

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 85;
2. Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas.

Exclusion Criteria:

1. Informed consent not available;
2. Carcinoma of colon or rectum with known involvement beyond the submucosa;
3. Evidence of distant spread of colon cancer;
4. Presence of another active malignancy;
5. Pregnancy;
6. Patients considered unfit for general anaesthesia;
7. The endoscopic platform cannot reach the target site;
8. Current participation in another clinical research study.
The Effect of Popliteal Plexus Block on Pain After Total Knee Arthroplasty

The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty

Cadaver dissection studies have shown a spread of dye to the popliteal fossa and colored the popliteal plexus by injecting in the distal part of the adductor Canal.

The popliteal plexus is formed by contribution from the tibial and the obturator nerves.

Investigators hypothesized that a PPB may reduce postoperative pain after total knee arthroplasty.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing total knee arthroplasty in spinal anesthesia
* age \> or = 18 years
* American Society of Anesthesiologists (ASA) status I-III
* Informed consent

Exclusion Criteria:

* Patients unable to cooperate
* Patients not able to speak Danish
* Pregnancy
* Contraindication towards ana Medical product used in the study
* Preoperatively reduced sensation on the medial and lateral part of the lower leg
* Patients with diabetic requiring Medical treatment
* Preoperative daily intake of opioids