cyrilzakka/clinical-trials huggingface dataset:
Study of Cryotherapy for Renal Tumors

The purpose of this study is to study the change of tumor size and serum cytokine in the patients who received cryotherapy for the renal tumors.


Eligibility Criteria:
Inclusion Criteria:

* The patients who have renal tumor less than 7 cm and receive cryotherapy

Exclusion Criteria:

* The tumor size is larger than 7 cm
* The patients do not approve the surgery
Molecular Profiling of Exosomes in Tumor-draining Vein of Early-staged Lung Cancer

This is an observational prospective single-center study of 30 patients operated for early-staged non-small cell lung cancer. The main aim is the analysis of molecular profiling of exosome with a sample in tumor-draining vein in order to identify prognostic molecular characteristics associated with cancer recurrence after surgery.

Surgical resection remains the best chance for cure in patients with early-stage non-small-cell lung cancer (NSCLC). Unfortunately, approximately 30-50% of patients will relapse within 5-year of curative surgery despite early TNM-stage. The Identification of prognostic biomarkers of relapse is a necessity. Among them, extracellular vesicles (exosomes) study seems promising in early stage cancers and samples directly in tumor-draining vein to. The pulmonary vein is draining blood directly from the lungs and sampling at this location could provide a higher yield for oncosome. The litterature reports that Navarro et al. are the only team to have link exosome characteristics to oncological outcomes following surgery. The investigators propose to analyze the molecular profiling mediated by these extracellular vesicles in the tumor-draining vein of operated patients.

A peripheral blood sample is recolted before surgery (D-1 or D0). During oncological lung surgery, the pulmonary tumor-drainage vein is first exposed and punctured with a needle prior to subsequent surgical manipulation for resection (D0). A piece of resected tumor will be analyzed for the study (D0). Quantification and size distribution of exosome and molecular cargo of exosome in blood samples (peripheral and pulmonary vein) and tumor are analyzed (DNA sequencing).

Standard clinical and radiological follow-up is then performed and 2-year overall survival and 2-year disease free-survival are checked.

Eligibility Criteria:
Inclusion Criteria:

- Surgical non-small cell lung cancer with pure solid nodule or part-solid ground glass nodule on CT-scan

Exclusion Criteria:

* Pure ground glass nodule,
* Neoadjuvant therapy,
* Second cancer or cancer in the 5 years,
* Pregnancy,
* Patients \<18 years-old,
* Tutorship
Intervention Study of an Individualized Exergame Training for People With Major Neurocognitive Disorder

This study evaluates the feasibility of the intervention and the study design.

This study evaluates the feasibility of the intervention and the study design. Furthermore, it investigates the effects of an exergame training including strength, balance, cognitive and pelvic floor muscle training. The main risk in this study is related to potential accidents/falls during the training (and not mainly to the data acquisition procedures). But as the difficulty of the training game is adaptive, the participants will always be challenged on an appropriate level for their physical condition. Furthermore, before and after the training period, several low risk measurements are conducted. This study contributes to fundamental research investigating how multicomponent exergame training influence physical and cognitive functions.

Eligibility Criteria:
Inclusion Criteria:

* Aged 60+ years
* Living in residency "de Wingerd" in Leuven (at least two weeks here)
* Being able to straight for minimal 10 minutes without aids
* Visual acuity with correction sufficient to see on a TV screen
* diagnosed with major neurocognitive disorder

Exclusion Criteria:

* Mobility impairments that don't allow to play the exergame
* Any unstable cardiovascular or other health condition which according to the American College of Sports Medicine Standards might lead to unsafe participation (e.g. recent cardiac infarction, uncontrolled diabetes or hypertension)
* Orthopaedic or neurological diseases that prevent exergame training
* Rapidly progressive or terminal illness
Observational Study on Non-steroid Anti-inflammatory Drugs (NSAIDs) Treated Patients With Arthritic Disorder

The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis)
* Already receiving NSAID treatment at enrolment visit

Exclusion Criteria:

* Inability to complete the study related questionnaires
* Current participation in any interventional study
Mangoselect®: Characterization, Pharmacokinetics and Bioavailability of Xanthone Metabolites

The aim of this study is to compare pharmacokinetics and bioavailability of phenolic compounds, mainly xanthones, from a mangosteen extract, either ingested in a dry powder form or in an encapsulated form. Absorption and metabolism will be determined by measuring urinary excretion of phenolic metabolites and blood metabolic profile over 72 hours by means of High Pressure Liquid Chromatography (HPLC) coupled with tandem mass spectroscopy.

The design of this study is a cross-over, double-blind and randomized trial on 10 healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent study
* Stated willingness to comply with all the study procedures and availability for the duration of the study
* Male and female
* Normal BMI range (18.50-24.99)
* In good general health as evidenced by medical history
* Ability to take oral medication and be willing to adhere to lifestyle considerations

Exclusion Criteria:

* Current use of any medication or food supplement
* Pregnancy or lactation
* Known allergic reaction to mangosteen
* Metabolic disorders or any kind of disease
* Currant smoker
Different Dietary Interventions and Glycemia in T1DM

The aim of the present study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (T1D).

The aim of the present crossover study was to compare the effects of three different dietary patterns on glycemia in individuals with type 1 diabetes (T1D).

Three different isocaloric diets, namely, a Mediterranean style diet, a low-carbohydrate diet and a reference diet were provided to patients with T1D for three separate weeks, in a random order, and with 7-day washout periods in-between. Glycemia was assessed during each 7-day period using a continuous glucose monitoring system. Participants were recruited from the outpatient diabetes clinic of a University Hospital in Athens, Greece.

The primary outcome was time spent in euglycaemic range (TIR: 70-140mg/dl) during the diet period. Secondary outcomes were: (a) time spent below euglycaemic range (TBR: \<70mg/dl); (b) time spent above euglycaemic range (TAR: \>140mg/dl); (c) glycaemic variability and (d) insulin needs.

Eligibility Criteria:
Inclusion Criteria:

* Adults with T1D receiving MDI therapy
* Sufficient education and knowledge on carbohydrate counting
* Motivation to follow a specific dietary schedule
* Frequent (7 times a-day) self-monitoring of blood glucose (SMBG)
* Willingness to wear a CGM system

Exclusion Criteria:

* HbA1c \>8%
* Lack of severe diabetic complications, such as cardiovascular disease, proliferative retinopathy, nephropathy with estimated glomerular filtration rate (eGFR) ≤ 60 or gastroparesis
Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery

Clinician directed use of bone morphogenetic proteins (BMPs) in ways other than FDA approved, has increased recently due to the morbidity associated with harvest of iliac crest bone graft in spinal arthrodesis procedures. FDA approved for the use in anterior lumbar fusions with LT Cage, other clinical applications of these proteins is becoming widely adopted due to their effectiveness in forming bone and facilitating fusion. Clinicians have realized while these proteins are potent stimulators of bone formation there have been anecdotal reports of increased rates of radicular pain in the postoperative period when used in interbody arthrodesis procedures. Speculation as to the mechanism of this radiculitis is postulated to be due to the inflammatory effects of these proteins. Excess bone overgrowth around the spinal nerves in proximity to the fusion cage has been reported. No prospective studies have been performed assessing the incidence and etiology of this complication. The investigators propose a prospective study evaluating the incidence of this complication as well as postoperative imaging studies to help determine whether bony overgrowth is indeed occurring adjacent to the effected spinal nerves.


Eligibility Criteria:
Inclusion Criteria:

* male or female age 18-75
* candidate for TLIF
* Lumbar levels L1-S1

Exclusion Criteria:

* more than 3 TLIF levels
* had a previous fusion attempt at involved level(s)
* had more than 2 previous open, lumbar spine procedures at the involved level(s)
* currently implanted with anterior instrumentation at the involved level(s)
* BMI \>40
* active localized or systemic infection
* presence of a disease entity or condition which significantly affects the possibility of bony fusion
* has immunosuppressive disorder actively requiring treatment
* pregnant or interested in becoming pregnant during the study
* has a known sensitivity to device materials
* mentally incompetent or is a prisoner
* currently a participant in another study for the same indications
Early Detection of Epidural Onset by Temperature Change

Traditionally, placement of the epidural catheter is based on hand feel of passing through the ligamentum flavum as well as "loss of resistance" while injecting the air through the needle. However, both are subjective and not necessarily encountered consistently. Moreover, the onset of sensory block is usually slow, thus making confirmation of catheter position a tough task and may delay the turnover of the operating room. The only way to confirm the catheter position objectively without delaying surgery is to find a reliable indicator within minutes of local anesthetic injection. In this study, we try to use the change of temperature in the big toe as a surrogate indicator of correct epidural catheterization.

Epidural anesthesia loading dose: 17ml 2% xylocaine + 2.3ml sodium bicarbonate + 2ml Rapifen (1088 mcg) + 0.1 mg epinephrine

Eligibility Criteria:
Inclusion Criteria:

* Body weight:50-90kg,
* American Society of Anesthesiologists physical status classification I-II,
* Under epidural anesthesia for surgery

Exclusion Criteria:

* History of receiving lumbar surgery
* Allergy to alfentanil ,xylocaine, bicarbonate
* Trauma
SWOC Activities on Balance, Gait and Endurance in Children With Autism Spectrum Disorder

Autism Spectrum Disorder (ASD) is a developmental disorder characterized by challenges in social communication, social interaction, repetitive behaviors, and restrictive interests.

Affecting 0.2-2% of children, ASD often includes motor growth retardation, which worsens over time. The disorder is more commonly diagnosed in boys, and its cause is believed to be genetic, with environmental stimuli potentially activating certain genes. This study aims to explore the effects of Standardized Walking Obstacle Course (SWOC) activities on balance, gait, and endurance in children with ASD, seeking to discover novel treatment techniques that could enhance clinical practices and improve motor skills in these children.

This randomized controlled trial will be conducted over 10 months, with data collected from the Lahore Autism Center and PSRD hospital in Lahore, Punjab. The sample will include 44 children with confirmed ASD, aged 8 to 12 years, divided into two groups: one undergoing SWOC activities and the other receiving conventional physiotherapy. Interventions will occur 4 days a week for 30-40 minutes each day. Pre- and post-treatment measurements will be taken using the Pediatric Balance Scale (PBS), the 6-Minute Walk Test (6MWT), and Functional Gait Assessment (FGA).

Data will be analyzed using SPSS version 24, with statistical significance set at P = 0.05.

4 weeks treatment plan.

Group A: A randomized controlled trial investigate the effect of a standard walking obstacle course activities on balance, gait and endurance in children with ASD. Activity could include navigating obstacles of varying height and width balancing on beam, stepping over hurdles and walking on different surfaces. 2-3 times for 4 weeks. Balance beam Stepping stones Hurdle Markers Soft Mats Balance activities Gait and Endurance activities

Group B: Either receive no interventions or engages in a different form of physical activities that doesn't focus on balance gait and endurance e.g standard physical education activities like walking, running climbing, jumping along with applied behavioral therapy, speech therapy and customized physical therapy. 2-3 times for 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Children with confirmed diagnosis of ASD.
* Age of patients 8 to 12 year.
* Both male and female.
* Fall less than 15 times in 30 seconds in Flamingo balance scale test.

Exclusion Criteria:

* Severe physical impairment.
* Severe intellectual impairment.
* Comorbid conditions that could prevent participation.
A Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes

The aim of this study is therefore to investigate the efficacy of the PEG-formulation to reduce the frequency and duration of genital herpes recurrences, to assess its safety and tolerability and to investigate its effect on shedding.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* 18 - 65 years
* Positive for HSV-1 and/or -2 (as determined by serology testing in course of study)
* Initial infection \> 1 year ago
* ≥ 6 recurrences in the last year (or in the year prior to a recent prophylactic therapy)
* ≥ 2 recurrences during the six-month baseline period

Exclusion Criteria:

* Known or suspected allergy or intolerability to PEG
* Prophylactic antiviral drugs, virostatic agents, cytostatics, immunomodulatory drugs and steroids within less than 14 days prior to baseline period, or plan to take such drugs during the trial
* Pregnancy and/or breast-feeding
* History of malignant diseases (described in chapter 7.2)
* Known or suspected non-compliance to study protocol
* Participation in another investigational drug study in the last 30 days prior to baseline period
PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE.

MULTICENTRIC INTERNATIONAL RANDOMIZED PHASE III TRIAL COMPARING, NEOADJUVANT CHEMOTHERAPY (BEC REGIMEN) FOLLOWED BY STANDARD RADIOTHERAPY (70 Gy / 7 WEEKS) VERSUS THE SAME NEOADJUVANT CHEMOTHERAPY FOLLOWED BY STANDARD RADIOTHERAPY ASSOCIATED WITH DAILY HYDROXYUREA IN THE TREATMENT OF LOCALLY ADVANCED UNDIFFERENTIATED CARCINOMA NASOPHARYNGEAL TYPE (UCNT).


Eligibility Criteria:
Inclusion Criteria:

* of either sex
* aged \*15 and \* 70 years
* never previously treated with radiotherapy, chemotherapy or surgery for malignant disease (except neck adenectomy/diagnosis)
* with aWHO performance status \* 2.
* amenable to regular follow-up
* capable of receiving chemotherapy and radiotherapy : in particular, with no contraindications to the use of anthracyclines, bleomycin or cisplatinum.
* with informed consent at entry time, in writing or witnessed oral informed consent, in accordance with local legislation requirements.
* Laboratory requirement : \*Baseline hematologic status :

Neutrophil count \* 2000 /mm3 Platelet count \* 150,000 /mm3 Hemoglobin \* 10 g / dl

Exclusion Criteria:

* Histologic types other than type II - III of the WHO classification
* T1 - T2 N0 - N1 or patients with metastatic
* Aged \< 15 or \> 70.
* Patients in whom chemotherapy is contraindicated: history of myocardial infarction over the last 6 months before inclusion, or clinically present cardiac pathology.
* WHO Performance status \>2
* History of prior malignancies (other than non melanoma skin cancer or excised cervical carcinoma in situ).
* Uncontrolled infection,
* Patients refusing participation.
* Patients who, for social, familial or geographic reasons are unlikely to comply with a long term follow-up.
A Study of Glutamine to Treat Intestinal Permeability in Functional Dyspepsia

The purpose of this research is to collect data from patients diagnosed with functional dyspepsia who are treated with glutamine and describe safety and treatment results compared to patients taking a placebo. Glutamine, an essential amino acid in humans, is an important energy source for cells lining the gastrointestinal tract and has been shown to play an important role in regulating the strength of the intestinal wall.


Eligibility Criteria:
Inclusion Criteria:

* Meet Rome IV criteria for functional dyspepsia (https://theromefoundation.org/rome-iv/rome-iv-criteria/)
* Patients will generally be in good health. During initial evaluation, patients' symptoms will be assessed and patients categorized into either the PDS, EPS or mixed subtype of FD.

Exclusion Criteria:

* Significant comorbid illness
* Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or if the patients have known esophagitis, eosinophilic esophagitis or H. pylori.
* Prior surgery to the esophagus, stomach or duodenum will be excluded, as will those taking proton pump inhibitors (PPIs), opioids, corticosteroids and those taking regular (daily) antihistamines, non-steroidal anti-inflammatory drugs (NSAIDs), or mast-cell stabilizing agents within the prior 2 weeks. Of note, patients taking PPIs will be given the opportunity to discontinue their PPI in favor of famotidine 20 mg daily for 2 weeks before enrollment.
* Known allergies to lactulose: mannitol.
* Active tobacco use and excessive alcohol use (defined as 8 or more drinks per week for women or 15 or more drinks per week for men; http://ww.cdc.gov)
* Co-existing IBS will be allowed to enter the study as long as symptoms are not predominant.
* Hepatic and renal impairment within the past 6 months. Defined as AST/ALT \> 2X ULN, Total Bilirubin \> 2 X ULN, Estimated Glomerular Filtration Rate (eGFR) of \< 60 mL/min/BSA.
* Diagnosed with galactosemia.
* Pregnant or breastfeeding women.
* Patients with documented or reported lactose intolerance.
First-in-Human Single and Multiple Dose of GLPG2222

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized.

The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.


Eligibility Criteria:
Inclusion Criteria:

* Males between 18-50 years of age
* Subjects must have a body mass index between 18-30 kg/m²
* Subjects must be judged to be in good health based upon the results of a medical history, physical examination, vital signs, 12-lead electrocardiogram and laboratory profile
* Subjects must have a screening spirometry with forced expiratory volume in 1 second ≥80% of predicted values for age, gender and height (Part 1 only)

Exclusion Criteria:

* A subject with a known hypersensitivity to study drug ingredients or a significant allergic reaction to any drug
* Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study
* A subject with active drug or alcohol abuse within 2 years prior to the initial study drug administration
* Current sexually active (and/or child wish) male; a contraception method must be used
Forced Air Versus Endovascular Warming in Polytrauma Patients

Trauma is the leading cause of death in young adults, bleeding and infection are major concomitant problems. We test the hypothesis that fast, perioperative warming with an endovascular catheter versus forced air warming may improve patient outcome (primary outcome: combined perioperative morbidity, secondary outcome: bleeding, infection).

Trauma is the leading cause of death in young adults and a major cause of morbidity and mortality at all ages. The acute problem is often uncontrollable bleeding. Subsequently, infection becomes a leading cause of morbidity. Polytrauma patients are at high risk for accidental hypothermia. Mild perioperative hypothermia causes a coagulopathy that significantly augments blood loss and increases allogeneic transfusion requirements. Hypothermia also impairs numerous immune functions - even slight decreases in core temperature triple the risk of surgical wound infection.

Endovascular temperature management system Alsius® (ICY, Alsius Corporation: Irvine,California,USA) has been approved in Europe and United States for the past 10 years and has been used in thousands of patients mainly for the indication of therapeutic cooling and subsequently rewarming of patients. A major potential advantage of this system is that heat is directly added to the thermal core, thus bypassing the heat sink and insulating effects of peripheral tissues. The efficacy of this system is sufficient to allow rapid rewarming in hypothermic trauma victims, even those undergoing major surgery. We therefore propose to test the hypothesis that polytrauma patients rewarmed with the Alsius® system will have better patient outcome (combined perioperative morbidity) than those warmed conventionally with forced-air.

Eligibility Criteria:
Inclusion Criteria:

We will evaluate patients admitted to the Emergency department for polytrauma. Patients will be eligible for the study when they:

1. Are between 18 and 70 years old
2. Have a Glasgow coma score ≥ 9
3. An ISS (Injury Severity Score) ≥16; and
4. Have A Severity Characterisation Of Trauma (ASCOT) score predicting mortality ranging from 2 to 50% (www.sfar.org/scores2/ascot2.html).

Exclusion Criteria:

Patients will be excluded if they are:

1. \<150cm in height
2. Known to have a vena cava filter
3. Known to have a history of coagulopathy including anti-coagulant medications; or
4. Known to be pregnant.
One Year Outcome After Robotic Assisted Laparoscopic Sacral Colpopexy, a Case Series Review

Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to its long-term outcomes. This advanced procedure is offered at MMH through the Urogynecology division. The Investigators setup to review the one year outcome of patients who underwent this procedure using a polypropylene mesh. These outcomes will include anatomical and quality of life measures.


Eligibility Criteria:
Inclusion Criteria:

* Any Robotic assisted laparoscopic sacral colpopexy with polypropylene mesh during the study period

Exclusion Criteria:

* Other graft material than polypropylene.
* Enrollment in a different study.