cyrilzakka/clinical-trials huggingface dataset:
Dose-Ranging Study to Assess the Safety, PK and Initial Antiviral Efficacy of NVR 3-778 in Chronic HBV Patients

This Phase 1b trial will assess the dose-related safety and PK profile of different doses of NVR 3-778 in patients with chronic hepatitis B. Additionally,changes in patients' serum HBV DNA levels and other virologic efficacy parameters will be assessed.

The Phase 1b assessments of the dose-related safety, PK, and initial antiviral efficacy of NVR 3-778 in hepatitis B patients will also be conducted at approximately 14 different sites to meet enrollment goals of 54-84 chronic hepatitis B patients.

To promote objective safety and tolerance assessments during this trial, study subjects, and site personnel administering the study drug and performing the clinical assessments on the subjects, will be blinded to individual subjects' treatments assignments (active NVR 3-778 or placebo doses), for all treatment cohorts in the study. Study advancement to subsequent patient cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol. Also, there will be one interim review of safety data by an independent Safety Monitoring Board (SMB), as described in the protocol.

Eligibility Criteria:
Patients may be male or female between 18 and 65 years of age, with a BMI of 18-35kg/m2. Patients must be HBeAg positive and have chronic hepatitis B with no history of clinical decompensation.
Clinical Trial to Evaluate Safety and Efficacy of Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) With Mitomycin C Used During Surgery for Treatment of Locally Advanced Colorectal Carcinoma

The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.

The purpose of this study is to determine whether Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) with Mitomycin C used during surgery for treatment of locally advanced colorectal carcinoma is effective in the treatment of locally advanced colorectal carcinoma.

The Hyperthermic Intra-peritoneal Chemotherapy (HIPEC) is expected to be an effective treatment with minimal side effects, it has already provided clear benefits in terms of overall survival in patients with advanced cancer.

This is an attractive option for the healthcare professionals who face daily to peritoneal recurrence after performing complex surgeries, however its application is difficult due to the cost and resources increase. This leads to the necessity of administering the treatment within a clinical trials and in order to obtain a significant power this clinical trials will be multicenter and it will be performed in several Oncological surgery Units highly specialised and with extensive experience in colorectal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients between the ages of 18 and 75 years;
2. Adenocarcinoma of the colon, sigma and colon-sigma joint which represent cT4a/b in line with The American Joint Committee on Cancer: the 7th edition of the AJCC cancer staging manual;
3. Lymph node involvement: N0, the presence of N1/2 according to the 7th edition of the AJCC is allowed, provided that they can be resectable;
4. Metastatic extent: M0;
5. Karnofsky index \>70 or Performance status ≤2;
6. Informed consent properly completed.

Exclusion Criteria:

1. Presence of metastases (M1), in case of liver or peritoneal metastases at the time of surgery, the patient will be excluded from the trial and treated according to their new stage.
2. Presence of unresectability criteria;
3. Urgent intervention due to obstruction or perforation if there is tumor removal, prior interventions will be accepted as referrals without primary tumor removal or drainage of collections prior to scheduled surgery.
4. Extraperitoneal rectal cáncer (avoiding alterations for neoadyuvance);
5. Coexistence of another malignant neoplastic disease (synchronous tumors of the colon and upper rectum are accepted as long as the stage is equal to or less than the treated tumor).
6. Severely altered liver, kidney and cardiovascular function;
7. Intolerance to treatment;
8. Administration of chemotherapy before the trial (use of neoadyuvance is discarded);
9. Pregnant or breastfeeding women.
Electrocardiographic and Cardiac Magnetic Resonance Predictors of Ventricular Arrhythmias in Cardiomyopathic Patients

This study aims to assess ECG changes for predicting ventricular arrhythmia in cardiomyopathic patients

This study aims to assess ECG markers based on 24-hour Holter ECG recordings for predicting ventricular arrhythmia in patients with Structural Heart disease who have left ventricular dysfunction and Left Ventricular Ejection Fraction ≤40%. With special concerns to underlying structural abnormalities in cardiomyopathic patients using Cardiac Magnetic Resonance to determine ventricular function, scar distribution, and grey zone analysis

Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic and non-ischemic cardiomyopathy, EF \< 40 %
* Patient haemodynamically stable
* Patients accept to make test

Exclusion Criteria:

1. Patients with underlying arrhythmia ex heart block or atrial arrhythmia like PACs, AF.
2. Patients on arrhythmogenic drugs ex digitalis, amiodarone.
3. Patients on underlying Pacemaker device or CRT-D.
4. Patients with MI in less than 40 days
5. Patients refuse to make test .
Effect of HFR-SUPRA in the Treatment of Multiple Myeloma-related Acute Kidney Injury

In patients with multiple myeloma-related acute kidney injury, compare the renal outcome of chemotherapy combined with HFR-SUPRA to chemotherapy combined with hemodialysis.

In patients with multiple myeloma-related severe acute kidney injury, compare the renal outcome between patients receiving HFR-SUPRA and patients receiving hemodialysis. Both groups of patients receive chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old
* new onset of multiple myeloma
* acute kidney injury with eGFR \< 15 ml/min/1.73m2 and need hemodialysis
* biopsy-proven cast nephropathy or clinical diagnosis of cast nephropathy based on exclusion of other causes of acute kidney injury including post-renal obstruction, hypercalcaemia, amyloidosis, light-chain deposition disease, contrast media and drug nephropathy
* serum light chain \> 500 mg/L

Exclusion Criteria:

* chronic kidney disease stage 3 to 5 (eGFR\< 60 ml/min/1.73m2 for at least 3 months)
* haemodynamics unstability
* active bleeding
* cardiovascular and cerebrovascular events in the last month
* other malignant tumor
* conditions not suitable to participate in the study, such as bad compliance
Abdominal Wall Block Study

Compare the ability of the transversus abdominis plane block (TAPB) and rectus sheath block (RSB) to provide surgical anesthesia for overweight and obese patients undergoing umbilical hernia surgery.

The purpose of this research study is to compare the ability of the TAPB and RSB to provide anesthesia for overweight and obese patients undergoing abdominal wall surgery. At the present time, this procedure is performed under general anesthesia, which often poses increased risks for overweight and obese individuals. It is not known if these blocks could be used to avoid the use of general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age undergoing umbilical hernia repair
* Overweight and obese individuals (defined as a body mass index of ≥ 25 and 30 kg/m2, respectively)
* Ability to understand and provide informed consent

Exclusion Criteria:

* Patient refusal or inability to provide informed consent
* True allergy, not sensitivity, local anesthetics
* True allergy, not sensitivity, Propofol
* True allergy, not sensitivity, general anesthetic agents
* Pregnancy
* Severe hepatic impairment
* Evidence of infection at or near the proposed needle insertion site
* Any sensorimotor deficit, whether acute or chronic, as determined by the PI
* Chronic use of opioid medication
Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones

Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the investigators prospectively compare these two methods for management of patients with preoperatively diagnosed common bile duct stones to settle the best option.


Eligibility Criteria:
Inclusion Criteria:

* preoperatively diagnosed common bile duct stones

Exclusion Criteria:

* liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy
Effects of Temporomandibular Disorder on Masticatory Efficiency

Temporomandibular disorders (TMD) are defined by pain in the temporomandibular joint (TMJ) and related tissues, limitations in the movements of the lower jaw, and TMJ noises.1,2 TMD are classified into four groups as temporomandibular joint disorders, masticatory muscle disorders, headache attributed to TMD and associated structures.3,4 Of these, masticatory muscle disorders are the most common TMD subtype seen in dental clinics.5-7 In general, two major symptoms are seen associated with masticatory muscle disorders: Pain and dysfunction. Pain is the vast majority of complaints about masticatory muscle disorders. The other important complaint is dysfunction, which occurs as a limitation in the opening range of the mandible.8 It is known that individuals with experimental muscle pain are slower than healthy individuals when biting hard food and show lower maximum voluntary clenching capacity.9 Also, it has been reported that the maximum bite force decreased in patients with temporomandibular disorders.10 These consequences directly affect patients' quality of life. Therefore, rehabilitation of limited masticatory functions is one of the important therapeutic goals for TMD patients.11 In TMD patients, masticatory functions can be measured objectively with bite force, bite force endurance, electromyography, and jaw kinematics, etc. Another objective method that can be used to determine masticatory functions is the masticatory efficiency test. In the literature, there are few studies that measure masticatory efficiency in TMD patients.12-16 Only two of these studies investigated the effect of TMD treatment and used the sieve method to measure masticatory efficiency.15,16 Although the sieve method is considered the gold standard, the procedure is complex and time consuming.17,18 To eliminate these disadvantages, masticatory efficiency measurement with two-color chewing gum tests which are simple and do not require special equipment or training can be used. The effect of many different conditions and treatments on masticatory efficiency was evaluated with this method.19 However, to our knowledge, there is no study in the literature evaluating TMD treatment with this method.

The aim of this study was to compare the masticatory efficiency with a two-color chewing gum test before and after treatment of the masticatory muscle-related temporomandibular disorder.


Eligibility Criteria:
Inclusion Criteria:

Presence of muscle-related temporomandibular disorder

Exclusion Criteria:

Patients under the age of 18, who had a missing tooth (except 3rd molars) or crown-bridge restorations, any intra-articular temporomandibular disorder were excluded from the study.
Improvement of Colonoscopy Preparation by Using a SPA

This study evaluates the impact of a SPA on Quality of bowel preparation for colonoscopy. Half of the patients receive regular paper based information on colonoscopy preparation (control), while the other half will use an additional SPA for colonoscopy preparation (coloprAPP).

Preparation for colonoscopy is perceived as a major impediment to participate in CRC screening colonoscopy. Hence, inadequate bowel preparation is reported in up to 25% of all patients undergoing colonoscopy.

Although the quality of bowel preparation is influenced by various factors, it largely depends on patient´s compliance regarding instructions on purgatives and diet. Therefore reinforced education and guidance is a valuable tool to improve bowel preparation.

A rapidly increasing number of individuals worldwide use smartphones in their daily life. Application of this new technology into patient education could facilitate and empower the patient guidance. In this study patients either receive regular information on colonoscopy preparation (paper-based) or download a SPA for reinforced reminding of the steps of colonoscopy preparation. Objective of this study is to measure the impact of a SPA on quality of bowel preparation.

Eligibility Criteria:
Inclusion Criteria:

* smartphone
* outpatient appointment for colonoscopy
* CRC Screening, surveillance
* \<ASA 3

Exclusion Criteria:

* no smartphone
* \>ASA 3 (no possibility for outpatient colonoscopy)
Faecal Analyses in Spondyloarthritis Therapy

This study evaluates the intestinal microbiome and disease activity in patients with spondyloarthropathies receiving immunosuppressive therapy.

Patients will be analysed at two time points in reference to two predefined primary endpoints:

* Changes in intestinal microbiome
* Response to therapy

The investigators want to evaluate if successful treatment of spondylarthropathy coincide with specific changes in the gut flora.

Tumor necrosis factor (TNF)-inhibition is an efficient medication for the treatment of spondyloarthropathy. In a substantial number of cases however, these medications remain ineffective. At present, the scientific community has limited understanding of why some patients are resistant to this medication. The purpose of this study is to understand if the gut flora may associate with treatment response.

Spondyloarthropathies are associated with inflammatory bowel diseases in terms of epidemiology and molecular pathogenesis. Recent studies have also associated spondyloarthropathies with intestinal dysbiosis.

This study is of observational character and integrated in the routine clinical care of patients with spondyloarthropathies at the Rheumatology Clinic, Skane University Hospital, Lund, Sweden. Study participants are asked to deliver blood and fecal sampling at two time-points together with clinical evaluation of disease activity. With an estimated inclusion of 50 patients, at least 20 responders and 20 non-responders are expected to be included and to be compared to each other.

Our primary goal is to investigate the association between change in intestinal microbiome and clinical response to therapy.

In our secondary analyses we will investigate if intestinal microbiome and intestinal inflammation at baseline may predict response to, and adherence to, therapy in these patients.

If successful treatment response of spondyloarthropathy is associated with specific alterations of the gut flora, these results may guide future studies on the impact of dysbiosis and probiotics on this disease.

Eligibility Criteria:
Inclusion Criteria:

* Fulfilling the Assessment of SpondyloArthritis International Society classification criteria for spondyloarthropathy.
* About to commence treatment with TNF-inhibition

Exclusion Criteria:

* Failure to understand protocol
* A history of alcohol abuse
* Any history of diverticulitis
* A history of failure to comply with prescribed medication
* Ongoing biological therapy
Collection and Study of Cerebrospinal Fluid in Patients With Hunter Syndrome

The purpose of the study is to collect data on CSF biomarkers in patients with Hunter Syndrome that would serve as reference data for comparison with cognitively impaired patients with Hunter syndrome, patients with other lysosomal storage diseases, or other diseases with CNS involvement.

To determine levels of glycosaminoglycans (GAGs), including dermatan sulfate (DS) and heparan sulfate (HS), GAG-degradation products, and other biomarkers of central nervous system (CNS) and lysosomal function in cerebrospinal fluid (CSF) in pediatric and adult patients with Hunter syndrome.

Eligibility Criteria:
Inclusion Criteria:

* The patient is male and has a documented diagnosis of Hunter syndrome (MPSII).
* The adult patient has completed a cognitive assessment at screening/baseline or within the previous 3 months and has been determined to have an intelligence quotient (IQ) ≥78. Note: cognitive evaluation of pediatric patients is not required.
* The adult patient or the adult patient's legally authorized representative(s) has voluntarily signed an Institutional Review Board/Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed.
* The pediatric patient must be scheduled to undergo a non-study related lumbar puncture or other medical or diagnostic procedure that requires the administration of general anesthesia. The pediatric patient's parent(s) or legally authorized representative(s) must have provided written informed consent (with patient assent as relevant), after all relevant aspects of the study have been explained and discussed, to allow CSF sample collection for this study in conjunction with performance of the non-study related procedure requiring general anesthesia.

Exclusion Criteria:

* The patient has a history of complications from a previous lumbar puncture(s) or technical challenges in conducting lumbar puncture.
* The patient has received a hematopoietic stem cell transplant.
* The patient has taken aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), or other over-the-counter or prescription medications that could affect blood clot formation within the 7 days prior to lumbar puncture, or has ingested such medications within 7 days prior to any study-related procedure in which a change in potential blood clot formation would be deleterious.
* The patient is currently receiving treatment with intrathecal idursulfase-IT.
* The patient is currently enrolled in an interventional clinical trial.
* The patient has participated in a clinical trial of any investigational drug, including idursulfase-IT, or device within the 30 days prior to study entry.
BeSingCardioRehab: CR in Belgium Versus Singapore

Background: Cardiac rehabilitation is indicated for ischemic heart disease patients; the program content of which is well described in both European and American guidelines. In contrast, literature on cardiac rehabilitation program content and efficacy in the Asian population is sparse.

Methods: BeSingCardioRehab will be an intercontinental, retrospective cohort study conducted in two cardiac rehabilitation referral centers in Belgium and Singapore. The first aim is to compare the impact of phase II center-based cardiac rehabilitation on Major Adverse Cardiac Events for ischemic heart disease patients between Europe (i.e. Belgian) and Asia (i.e. Singaporean) in the long-term. The second objective is to compare the efficacy of phase II cardiac rehabilitation on short-term morbidity (assessed with the validated SMART Risk Score) between index European and Asian ischemic heart disease patients. The level of compliance of the Belgian and Singaporean cardiac rehabilitation programs to European guidelines standards will also be evaluated.

Hypotheses BeSingCardiorehab will be one of the first studies assessing cardiac rehabilitation in Asia. Based on the BeSingCardioRehab study results, phase II center-based cardiac rehabilitation programs, can/will be adapted in order to improve program content and outcomes.

BeSingCardioRehab is an intercontinental, multi-center, retrospective cohort study conducted in two cardiac rehabilitation referral centers (Heart Center Hasselt in Belgium and National Heart Center Singapore in Singapore).

Patients will be divided in four groups (1:1:1:1) based on i. whether or not they received phase II cardiac rehabilitation and ii. whether they are from Belgium or Singapore.

The first objective of BeSingCardioRehab is to compare the impact of phase II center-based cardiac rehabilitation on Major Adverse Cardiac Events for ischemic heart disease patients between Europe (i.e. Belgian) and Asia (i.e. Singaporean) in the long-term. The second objective is to compare the efficacy of phase II cardiac rehabilitation on short-term morbidity (assessed with the validated SMART Risk Score) between index European and Asian ischemic heart disease patients. The level of compliance of the Belgian and Singaporean cardiac rehabilitation programs to European guidelines standards will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

i. patients in the revascularised, stabilized and asymptomatic phase following an acute coronary syndrome (ACS) (unstable angina, non ST-elevation ACS or ST-elevation ACS)

ii. patients initially presenting with stable angina who are revascularised or asymptomatic under optimal medical treatment (not amenable for revascularization).

Exclusion Criteria:

i. end-stage chronic kidney disease (stage V, GFR \< 15 ml/min/1.73 m2 and/or dialysis) ii. severe chronic obstructive pulmonary disease (COPD) (GOLD stage III-IV, Tiffeneau index \< 0.70 and FEV1 \< 49% of normal) iii. terminal cancer with a prognosis of \< 1 year.
Intravenous Versus Oral Acetaminophen for Postoperative Pain Control After Cesarean Delivery

This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a randomized, open label study.

This study will compare IV versus PO acetaminophen for postoperative pain in parturients after scheduled, elective Cesarean delivery. It is designed as a randomized, open label, controlled trial. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three by a computer generated list.

Eligibility Criteria:
Inclusion Criteria:

* Parturients 18 years
* Elective Cesarean delivery
* Spinal anesthesia
* Able to consent to the study and participate in the follow-up.

Exclusion Criteria:

* Weight under 50 kgs
* Allergy to acetaminophen
* General anesthesia
* Urgent or emergent cases
* Bleeding diathesis or other coagulopathy
* G6PD deficiency
* Liver disease
* Substance abuse or dependence
* HELLP syndrome
* Thrombocytopenia or platelet dysfunction
* History or active gastrointestinal bleeding
* Acute kidney injury or chronic renal insufficiency
* Contraindication/refusal to spinal anesthesia
* Chronic pain
* Chronic narcotic use
* Illicit drug use
* Allergy to any study related medications.