cyrilzakka/clinical-trials huggingface dataset:
Propellers Flaps for Meningomylocele Defects

To evaluate reliability of free style propeller perforator flap for coverage MMC soft tissue defect follow a well-established step that overcome the usual problem of pedicled perforators propellers flaps.

Meningomyelocele is a serious congenital birth defect that not only affect mortality and morbidity of neonate but also a lifelong health problem.

The estimated incidence of spina bifida is 1-2 cases per 1000 population. Meningomylocele soft tissue defect reconstruction is considered a lifesaving procedure , the ideal coverage technique should be time limited , reliable and allow healing line to be away from repair of the dura . all of these criteria are available in the selection of free style propeller perforator flap as a method of reconstruction.

Eligibility Criteria:
Inclusion Criteria:

* All cases with dorsolumbar meningomyelocele and age up to 6 months

Exclusion Criteria:

* Infants older than 6 months
* concomitant congenital anomalies
* concomitant spinal kyphosis
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs

The primary purpose of this study is to assess the effect of Debio 4126 in the maintenance of the levels of insulin-like growth factor 1 (IGF-1) ≤1x upper limit of normal (ULN) in the double-blind period (Period 1) in comparison to placebo at week 36.


Eligibility Criteria:
Inclusion criteria

1. Patients ≥18 years of age
2. Patients who are receiving octreotide or lanreotide monotherapy for acromegaly for at least 6 months, at a stable dose for the last 12 weeks.
3. IGF-1 at screening ≤1x ULN
4. Acromegaly diagnosis, defined as per protocol
5. Adequate bone marrow, hepatic and renal function
6. To enter Period 2 (Arms A and B): IGF-1 ≤1x ULN at Week 34, or up to Week 48 when treated with rescue medication
7. Other protocol-defined criteria apply

Exclusion criteria

1. Compression of optic chiasm causing visual defects
2. Symptomatic cholelithiasis or bile duct dilatation
3. Planned cholecystectomy during the trial duration
4. Acute or chronic pancreatitis
5. Pituitary radiotherapy
6. Uncontrolled hypothyroidism
7. Uncontrolled diabetes
8. Pituitary surgery within 6 months before screening or planned on trial
9. Treatment with pasireotide within 6 months prior to screening, pegvisomant or dopamin agonists within 3 months prior to screening
10. Recent or ongoing cardiovascular or thromboembolic diseases including heart failure, myocardial infarction, stroke, certain arrythmias, pulmonary embolism
11. Other protocol-defined criteria apply
Comparison of Colesevelam Hydrogen Chloride (HCl) Powder For Oral Suspension Versus Generic Cholestyramine Through Use of the Bile Acid Sequestrant Acceptability (BASA) Scale

The objective of this study is to compare the acceptability of Colesevelam HCl powder for oral suspension versus generic cholestyramine via the BASA scale, based upon an anticipated equivalent cholesterol lowering doses of each comparator drug.

In 2009, colesevelam HCl was approved as a powder formulation. Little objective evidence exists comparing the acceptability of colesevelam HCl powder for oral suspension formulation versus other bile acid sequestrant powder formulations. A Bile Acid Sequestrant Acceptability (BASA) Scale was developed and validated as an instrument to compare the acceptability of different bile acid sequestrant preparations

Eligibility Criteria:
Inclusion Criteria:

* Men or women 18-70 years of age
* In general good health (defined as study participants who are medically stable, meet protocol criteria, but who may also have non-exclusionary ongoing medical conditions).
* Subjects are capable of giving informed consent, or if appropriate, have an acceptable surrogate capable of giving consent on the subject's behalf.
* Subjects are willing and readily able to be contacted for post-study safety phone call assessments one to seven days after the single study visit.

Exclusion Criteria:

* Prior intolerance to bile acid sequestrants
* Known Phenylketonuria. Colesevelam (Welchol) for Oral Suspension contains 48 mg phenylalanine per 3.75 gram dose.
* Women who are either pregnant, or who are not practicing any form of birth control.
* Prior gastrointestinal surgery
* History of ongoing gastrointestinal symptoms (indigestion, constipation, or diarrhea)
* History of bowel obstruction, malabsorption, or irritable bowel syndrome
* History of esophageal disease
* Current or past history of gallbladder disease
* History of pancreatitis
* Subjects enrolled in another experimental (interventional) protocol within the past 30 days prior to visit 1.
* Diagnosis of diabetes mellitus
* Known history of triglyceride levels \> 300 mg/dl.
* History of alcohol or drug abuse within 1 year of study entry
* Alcohol intake that exceeds more than 2 units of alcohol drinks per day
* Exposure to bile acid sequestrants (colesevelam HCl, cholestyramine, colestipol within 30 days of visit 1).
* Any other situation in which the Investigator makes the judgment that participation in the study would not be in the best interest of the study participant, or in the best interest of providing reliable study data.
Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody

This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.

A preoperative 124I-cG250 PET scan may distinguish between clear cell and non-clear cell renal carcinoma in patients with renal masses. Studies of imaging characteristics of 124I by a variety of PET cameras, quantification of tumor uptake of 124I-labeled antibody and correlation with biopsy measurement of tumor and normal tissue have met with encouraging results. As clear cell renal cancers are associated with an aggressive phenotype their a priori determination may help guide appropriate surgical/therapeutic management.

Eligibility Criteria:
Inclusion Criteria:

* Subject is over 18 years of age.
* Presence of a renal mass.
* Scheduled for surgical resection of renal mass (partial or total nephrectomy, open or laparoscopic technique).
* Expected survival of at least 3 months.
* Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
* The following laboratory results should be within the following limits within the last 2 weeks prior to study day 1:

  * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  * Platelet count ≥ 100 x 109/L
  * Serum bilirubin ≤ 2.0 mg/dL
  * Aspartate aminotransaminase (AST) ≤ 2.5 x ULN
  * Alanine aminotransferase (ALT) ≤ 2.5 x ULN
  * Serum creatinine ≤ 2.0 mg/dL (calculated creatinine clearance \>45 ml/min)
* Negative serum pregnancy test; to be performed on female patients of childbearing potential within 24 hours prior to receiving investigational product. All females of childbearing potential must indicate intent to avoid pregnancy and must use an accepted, effective method of contraception for the duration of the study.
* Recovered from toxicity of any prior therapy.
* Able and willing to give valid written informed consent.

Exclusion Criteria:

* Metastasis of primary tumor other than Renal Cell Carcinoma (RCC).
* Prior history of malignancy within the last 5 years.
* Prior exposure to murine proteins or chimeric antibodies.
* Intercurrent medical condition that may limit the amount of antibody to be administered.
* Intercurrent medical condition that renders the patient ineligible for surgery.
* New York Heart Association Class III/IV cardiac disease.
* History of autoimmune hepatitis.
* Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to 124I-cG250 infusion on day 1.
* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
* Lack of availability for immunological and clinical follow-up assessments.
* Participation in any other clinical trial involving another investigational product within 4 weeks prior to enrolment.
* Women who are pregnant or breastfeeding.
* Allergy to iodine, hyperthyroidism, or Grave's Disease.
* Known allergic reaction to human serum albumin.
* Contraindication for contrast-enhanced CT or PET/CT.
* Contraindication to potassium iodide intake (see package insert).
The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements

Vasopressors may be needed after head and neck microvascular reconstructions to maintain sufficient mean arterial pressure. This is crucial for the flap survival. The study hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue oxygen level and microdialysate metabolites.


Eligibility Criteria:
Inclusion Criteria:

* head and neck cancer patients having tumor ablation surgery and reconstruction with microvascular radial forearm flap

Exclusion Criteria:

* Patients having contraindications for the operation.
* Patient refusal to participate in the study
Intravenous Antibiotic Treatment at Home

The purpose of the study is to develop and evaluate a new model for across services interaction with the use of welfare technology and telemedicine. The model includes innovative and new routines for the exchange of patient information, quality systems and procedures between the municipality and the hospital. This model will first be tested for use in intravenous antibiotic therapy. The results of the study will be used to further develop the service. In the larger context, it is desirable to provide knowledge that is transferable to other diagnostic groups, treatment methods and geographical areas.

This research-based innovation study has an evaluation approach with follow-up evaluation as the overall approach.

The pre-project was carried out with a qualitative approach under the auspices of SINTEF 2018/2019.

The main project consists of sub-study 1 and sub-study 2 (2020/2022).

Sub-study 1: The project use an iterative, user-centered service methodology with a qualitative approach. Here, SINTEF has the main responsibility for a qualitative summary after conducting interviews, observations and group discussions with patients, next of kins and health professionals regarding the development and testing / quality assurance of the new concept / service course for home treatment.

Sub-study 2: The approach here is quantitative. Descriptive data must be obtained from the hospital and municipal patient records, patient administration system (PAS) at Kristiansund hospital, alarm data from the Regional Response Center and pump log from the individual patient's infusion pump after home treatment.

Eligibility Criteria:
Inclusion criteria:

* Main or bi-diagnosis during stay:

A692 Borreliosis G00 - G009 Central nervous system inflammatory disorders I33 Endocarditis J86 Empyema D46.3 Spondylodiscitis M86 Osteomyelitis T84 Prosthesis / osteosynthesis infections M00.0-M00.9 Pyogen / septic arthritis J40-J47 Chronic diseases of the lower respiratory tract

* Competent to give consent
* The infection can not be treated with oral antibiotics in monotherapy
* Selected IV antibiotics must be suitable for administration via selected pumps
* The patient's condition is stable and does not require frequent observation by health care professionals
* The patient is motivated and willing to participate in intravenous treatment in home hospitals
* Must, after training, demonstrate mastery of practical procedures related to pump handling and any other procedures described in the patient's treatment plan
* The home must be suitable for intravenous antibiotic treatment; access to refrigerators, hygienic conditions, social conditions
* The patient must have a mobile phone and be able to handle the system for fast and secure communication with the Regional Response Center (RRO)

Exclusion criteria:

* consent not given
Avalus European Registry - an Observational Study to Evaluate Safety and Efficacy in a Real World Population

This is a prospective, observational, single-arm, multi-center registry of patients undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.

The study is a prospective, observational, single-arm, multi-center registry. The patients must undergoing bioprosthetic aortic valve replacement with the Avalus valve. This prospective registry aims to examine the outcome and performance of surgical aortic valve replacement with the Avalus pericardial bioprosthesis.

The goal of this project is to evaluate the real world results of aortic valve replacement with the Avalus valve. This will result in clinical and hemodynamic knowledge of this particular valve. The investigators are aiming for 1000 patient inclusions distributed over 40 sites across Europe and potentially also involving Canada.

Intentionally, we kept the inclusion criteria as wide as possible in order to obtain a real-world experience with and performance of the bioprosthesis. Patients younger than 18 years and salvage procedures are the only exclusion criteria from the registry. Outcome is evaluated in accordance with the VARC-2 criteria up to 1-year postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Clinical indication for replacement of the native or prosthetic aortic valve with a bioprosthesis
* Age \>= 18 years
* Patient has been adequately informed of risks and requirements of the registry (which are actually limited since the prosthesis is in full commercial use and only data registration is performed) and is able to provide informed consent for participation in the clinical registry.

Exclusion Criteria:

* Patient requires salvage surgery (according to EuroSCORE II definitions: "patients requiring cardiopulmonary resuscitation (external cardiac massage) en route to the operating theatre or prior to induction of anaesthesia. This does not include cardiopulmonary resuscitation following induction of anaesthesia")
* Not been able to provide informed consent
Observational Clinical Study of the Natural Course and Long-term Prognosis of Patients With Chronic Liver Disease

Chronic liver disease is a global public health problem. Without timely diagnosis and treatment, chronic liver disease can progress to hepatitis, liver fibrosis, and cirrhosis, while causing a variety of complications such as gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome, and liver cancer. Early detection and treatment can slow down the progression of chronic liver disease and reduce the burden of patients. This study intends to construct a retrospective-prospective cohort of patients with chronic liver disease by building a multicenter collaborative network to study the disease characteristics, progression patterns, clinical features, natural course and long-term prognosis of chronic liver disease of different etiologies.

Different etiologies can lead to chronic liver disease, and common causes include non-alcoholic fatty liver disease (NAFLD), hepatitis B virus (HBV), hepatitis C virus (HCV), alcohol-related liver disease (ALD), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC) and autoimmune hepatitis (AIH). In recent years, with the popularization of HBV vaccination and the advancement of drugs for the treatment of viral hepatitis, the incidence of cirrhosis has been curbed in many countries, but obesity, metabolic syndrome and alcohol abuse have led to an increase in the incidence of NAFLD and ALD recently. The large number of patients with cirrhosis causes loss of social workforce and depletion of medical resources, as well as increased family stress and reduced quality of life. As a result of that, cirrhosis remains a public health problem that cannot be ignored.

To better understand the natural course and clinical characteristics of chronic liver disease due to different etiologies, this study proposes to establish a multicenter, large sample, long-term follow-up cohort of patients with chronic liver disease to improve the clinical data related to chronic liver disease in China. This cohort study will help us to better manage patients with chronic liver disease and build on this foundation for epidemiology, interventions, and prognosis of chronic liver disease. The cohort and experience generated from this study serves as a support for a series of future studies to focus on clinical issues such as low-level viremia, other complications of cirrhosis, liver failure, end-stage liver disease, and liver cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who regularly visit and follow up at the corresponding liver disease center
2. All patients meet at least one of the following diagnostic criteria for chronic liver disease:

   * Chronic viral hepatitis B

     * Chronic viral hepatitis C ③. Chronic viral hepatitis D ④. Autoimmune liver disease (PBC/AIH/PSC) ⑤. Non-alcoholic fatty liver disease ⑥. Alcoholic liver disease

Exclusion Criteria:

1. First visit diagnosed with hepatocellular carcinoma or after liver transplantation.
2. Combined with other advanced malignant tumors.
3. The patient refused to sign the informed consent form to participate in this study.
Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT)

The sudy purpose is to investigate efficacy and safety of percutaneous endovascular aortic aneurysm repair using INCRAFT stent graft for Korean patients with abdominal aortic aneurysm. This study is designed as an investigator-initiated, multi-center, single-arm, prospective registry study. A total of 100 patients who meet all inclusion criteria, but none of exclusion criteria will be enrolled after the implantation of INCRAFT stent graft. The primary efficacy outcome is technical success defined as successful deployment of the stent-graft with no type I/III endoleak, unintentional coverage of visceral aortic branches or internal iliac arteries at the end of the procedure, and with successful removal of the delivery system. The primary safety outcome is major vascular complications at 30 days including. The study subjects will be followed for 12 months.

Prospective single-arm multicenter registry

Eligibility Criteria:
Inclusion Criteria:

* 1. AAA with one of following indications

  1. AAA with maximum diameter \> 5 cm,
  2. AAA with maximum diameter \> 4 cm with an increase \>0.5 cm during the preceding 6 months
  3. Saccular type AAA irrespective of the sac diameter.
* 2. Proximal aortic neck length ≥10 mm with a diameter ≥ 17 and ≤ 31 mm in combination with supra- and infrarenal angulation ≤ 60 degree.
* 3. Iliac landing zone with a length ≥15 mm and a diameter ≥ 7 and ≤ 22 mm
* 4. Femoral access vessels should be adequate to fit the selected delivery system
* 5. Minimum overall AAA treatment length (proximal landing location to distal landing location to distal landing location) ≥128 mm
* 6. Aortic bifurcation \>18 mm in diameter
* 7. Patents with age of 19-80 years.
* 8. Male or non-pregnant female
* 9. Voluntary participation in the study with signed informed consent form.

Exclusion Criteria:

* 1. Dissecting or ruptured abdominal aortic aneurysm
* 2. Presence of connective tissue disease (Marfan's syndrome or Ehlers-Danlos syndrome).
* 3. Prior AAA or iliac artery repair
* 4. Active infection or active vasculitis.
* 5. Myocardial infarction or cerebrovascular accident within 3 months prior to study enrolment.
* 6. Need for renal artery coverage (e.g. Chimney graft)
* 7. Dialysis-dependent renal failure or serum creatinine \>2.0 mg/dl
* 8. Intolerance/hypersensitivity to contrast media or antiplatelet drugs.
* 9. Positive pregnancy test.
* 10. Participation in another medical research study within 1 month of study enrolment.
* 11. Planned concomitant surgical procedures (other than left subclavian artery transposition or bypass) or major surgery within 30 days of study enrolment.
* 12. Patients with life expectancy less than 1 year
Long-Term Comparison of Fixed- and Mobile-Bearing Total Knee Arthroplasties (TKAs) in Patients With OA ≤50 Years Old

The purpose of the prospective study was to evaluate the minimum fifteen year follow-up of prospective total knee arthroplasties performed in patients younger than fifty years of age with osteoarthritis, using fixed- and mobile-bearing knee prostheses in the same patients, to compare

1. functional scores
2. rates of radiographic failure
3. revision rates
4. survivorship

The randomized prospective comparison of fixed- and mobile-bearing total knee designs in the same patients younger than fifty years of age is limited. The purpose of this study was to compare the long-term clinical and radiographic results of fixed- and mobile-bearing total knee arthroplasties in patients younger than fifty years of age with osteoarthritis.

Eligibility Criteria:
Inclusion Criteria:

* End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease

Exclusion Criteria:

* Inflammatory disease
* Patient with other Lower extremity disease which may affect functional outcome
* Neurologic disease effecting patients lower extremity
* Revision surgery
* Patient not medically cleared for bilateral surgery
Efficacy of Only IV Artesunate Versus IV Artesunate Plus IV Quinine in the Treatment of Severe Malaria in Children: A Comparative Study

The WHO recommends artesunate as the drug of choice for the treatment of severe malaria. However, the efficacy of this single drug as compared to the combined drug regimen remained questionable, and the clinical response was considered delayed or inappropriate. Therefore, this research intended to evaluate the efficacy of only IV artesunate versus IV artesunate plus IV quinine in the treatment of severe malaria in children. The findings of the study would be helpful knowing whether the two drugs, when given together, have considerable benefit over single-drug therapy when given for the same.


Eligibility Criteria:
Inclusion Criteria:

Children admitted to the emergency department with the diagnosis of severe malaria.

Exclusion Criteria:

Children with chronic kidney disease, chronic liver disease, immunosuppressive disorders, hematological disorders, malignancies, and congenital heart disease.