cyrilzakka/clinical-trials huggingface dataset:
The Membrane Adsorbing OXiris Filter in Septic Patients With AKI

Patients with Sepsis / Septic Shock and AKI are submitted to Continuous Renal Replacement Therapy with the oXiris filter . The pro- inflammatory mediators , the endotoxin , interleukin 10 , the main cardiorespiratory indices and renal parameters are evaluated at the entry of the study and at the end of the treatment.

Patients with a diagnosis of sepsis or septic shock Gram + , Gram - and acute renal failure All patients are submitted to Continuous Renal Replacement Therapy with the treated heparin-coated membrane (oXiris;Baxter );

* Citrate Anticoagulation or Heparin with thromboelasthograpy monitoring .
* Hemodynamic monitoring with dynamic parameters ( Cardiac Index ,Stroke Volume Variation , Pulse Pressure Variation ) and Echocardiography
* Indirect Calorimetry ( before Continuous Renal Replacement Therapy and after 1 hour stopping Continuous Renal Replacement Therapy )
* Laboratory: white blood cell, creatinine, procalcitonin, Interleukin -6, Interleukin -10, Endotoxin , Lactate, diuresis, tromboelastography (post filter and arterial sample ) and dosage of Plasminogen Activator Inhibitor -1 at the same sites.

Eligibility Criteria:
Inclusion Criteria:- Age \<18 years 75 years \>

* Diagnosis of sepsis or septic shock (Sepsis III)
* Mechanical Ventilation or non Invasive ventilation with PaO2 /FIO2 \< 200.
* Renal failure ( AKI ≥ 1)
* Endotoxin ( EAA ) : EAA ≥ 0.6 -0.9 \> or IL6 \> 150 pg/mL

Exclusion Criteria:

* Pregnancy;
* Age \< 18 years 75\>
* Chronic Renal failure or previous CRRT
* Immunological disease or immunosuppressive drugs or EAA \< 0.6 with IL 6 in the normal range.
* CGS \< 8 due to hemorrhagic or ischemic event.
* ECMO v-v or a-v or ECCO2 removal.
* No resolution of the surgical source of infection
* Terminal condition
* Any contraindication to heparin and other anticoagulant.
* Other pathological conditions in which the oXiris filter is not indicated and other therapeutic options are required. (eg . Hepatic failure , Cardiac failure )
Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening.

This is a phase 2b, multicenter, prospective, randomized, double-blind, placebo-controlled, crossover study in symptomatic celiac disease patients attempting a GFD for at least one year prior to screening. Seropositive patients (blood test confirmed at Visit 0) will be scheduled for a Screening Visit (Visit 1) whereas seronegative patients will be discontinued from study participation (screen failures). Patients who meet Visit 1 protocol enrollment criteria will be enrolled and begin the first of two 6 week periods.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy confirmed CD diagnosis
* Seropositive
* Gluten free diet (12 months minimum)
* Experienced at least one self reported moderate or greater severity symptom during the last 28 day period
* Willing to take study treatment daily
* Must sign informed consent

Exclusion Criteria:

* Wheat allergy
* History of peptic ulcer disease, esophagitis, IBS, IBD
* Active colitis, dermatitis herpetiformis
* Diagnosed with Type 1 Diabetes
* Patients with known rapid gastric emptying (post-bariatric surgery, Billroth I or II surgery)
* Chronic infectious gastrointestinal illness or acute infectious gastrointestinal illness within the 4 week period prior to screening
* Known refractory celiac disease (RCD1 or RCD2)
* Inability to give informed consent
Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery

This study aimed to examine the effects of obesity and bariatric surgery on gut microbiota in a Turkish population, and to contribute to the literature by bringing multi-dimensional parameters including dietary intake, metabolic and inflammatory markers. This case-control study was conducted between June 2015 and August 2019. All participants were followed during the six-month period. Face-to-face interviews and physical examinations were held, and blood and fecal samples were collected at the baseline (M0) and at the end of 3 (M3) and 6 months (M6). Dietary intakes of subjects were assessed using 24-h dietary recall method in each interview and a detailed quantitative food frequency questionnaire that involved 85 food items. Subjects were recruited to the study as three groups: 15 patients who had bariatric surgery as study group, 8 morbidly obese participants who did not have bariatric surgery as control group-1 and 11 participants who were non-obese (lean (n=5) and pre-obese (n=6)) as control group-2. All subjects in the study group had sleeve gastrectomy. Subjects in control groups were selected as age and gender matched with the participants in the study group. Individuals were excluded if (a) they were under 19 or above 65 years old, (b) they had an acute or chronic inflammatory disease, (c) they were diagnosed with infectious diseases, cancer or alcohol addiction, (d) they used antibiotics in last 3 months before the screening.


Eligibility Criteria:
Inclusion Criteria:

* morbidly obese participants for study and control group-1
* non-obese participants for control group-2

Exclusion Criteria:

* they were under 19 or above 65 years old,
* they had an acute or chronic inflammatory disease,
* they were diagnosed with infectious diseases, cancer or alcohol addiction,
* they used antibiotics in last 3 months before the screening.
Evaluation of Reporting of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor Inhibitors Associated Cardiovascular Adverse reactioN.

Antiangiogenics (AAs) which are vascular endothelial growth factor (VEGF) or VEGF receptor (VEGFR) inhibitors might have high grade adverse events (AEs) on the cardio-vascular system. This study investigates reports of cardio-vascular toxicity with treatment including VEGF and VEGFR inhibitors using the World Health Organization (WHO) database VigiBase.

AAs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and used in combination. However, AEs can occur. Here the investigators use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify cases of cardiovascular adverse drug reaction following treatment with AAs.

Eligibility Criteria:
Inclusion Criteria:

* Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2018
* Adverse event reported were including the MedDRA terms: Cardiac disorders (SOC), Vascular disorders (SOC), Sudden death (PT)
* Patients treated with antiangiogenics included in the following list:

Exclusion Criteria:

* Chronology not compatible between the drug and the toxicity
Investigate Efficacy, Safety, and Pharmacokinetics of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome.

The purpose of this study is to investigate the efficacy of enzastaurin compared to placebo in preventing arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading to intervention or mortality attributable to an arterial event in patients with vEDS confirmed with pathogenic heterozygous COL3A1 gene mutations predicted to derive a mutant protein.

The primary efficacy endpoint of this study will be defined as the time to intervention for an arterial event (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) or mortality attributable to an arterial event, as adjudicated by an Event Committee, and will be analyzed for difference of active vs. placebo treatments on top of background standard of care, using survival statistical analysis. Furthermore, secondary endpoints will include the rate of intestinal rupture, pneumothorax, and retinal detachment, as adjudicated by an Event Committee, safety and tolerability, as well as hospitalizations and Health Related Quality of Life (HQRL) measures.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects aged 18 - 60 years old at time of initial screening.
2. Adolescent subjects aged 12 - 17 years old, may be considered to enroll later in the clinical trial pending interim analysis.
3. Diagnosis for VEDS (vascular Ehlers Danlos Syndrome), with a confirmed and documented COL3A1 genetic variant.
4. Subject should be stable, having no VEDS-related vascular events within the past 3 months prior to enrollment.
5. Confirmed use of contraception for both male and female participants.

Exclusion Criteria:

1. Inability to swallow or receive intact tablets.
2. Currently being treated with CYP3A4 inhibitors within 4 weeks prior to enrollment.
3. Known allergy or hypersensitivity to enzastaurin.
4. Patient currently pregnant or breast feeding.

Other criteria will be reviewed at the first study visit to determine if you are able to participate in the study.
Rickets Device - Feasibility Study

On a daily basis many (prematurely born) newborn are subjected to different urine collecting techniques to study biochemical abnormalities. Neonatology nurses and pediatricians are looking for a better and less invasive manner to collect urine in these vulnerable patients. We hypothesise that the urine collecting device as presented in this protocol is less invasive and has good functional abilities to collect urine in these newborns

Objective of the study:

Clinical feasibility of the urine collection device, indicated by staff and parents.

Study design:

The study will be an open label, clinical feasibility study, of the urine collection device. During a period of 6 months, 30 feasibility tests will be performed.

Study population:

Prematurely born newborns, admitted to the neonatology unit of the department of pediatrics at Rijnstate Hospital Arnhem.


Eligibility Criteria:
Inclusion Criteria:

* Neonates admitted to the neonatology unit of the paediatrics department of Rijnstate Hospital Medical indication for urine testing for Calcium, Phosphate and Creatinine levels Informed consent from parents

Exclusion Criteria:

* No informed consent
* Defective skin in genital region
* Three previous tests in the same subject
Evaluation of Lung Doppler Signals in Pulmonary Hypertension

The purpose of this study is to evaluate the lung Doppler signals in patients with pulmonary hypertension that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether this non-invasive tool could be used in pulmonary hypertension diagnosis and monitoring.

PROTOCOL SUMMARY

Title: Evaluation of lung Doppler signals (LDS) in pulmonary hypertension (PHTN) Device: SONARA/tek transcranial Doppler (TCD) system Study Objectives: To evaluate the LDS in patients with PHTN that undergo (prospective arm) or underwent (retrospective arm) right heart catheterization (RHC) in order to assess whether these signals can be used in pulmonary hypertension diagnosis and monitoring.

Study Design:

Two study arms:

1. Prospective arm to measure LDS during right heart catheterization in patients undergoing the procedure for evaluation of PHTN.
2. Retrospective arm to measure LDS in patients in whom previous RHC confirmed the presence of PHTN.

Recruitment target: Prospective arm: 50 patients during 18 months. Retrospective arm: 50 patients during 18 months.

Study Population:

1. Patients suspected of PHTN by echocardiogram, who are scheduled to undergo RHC (prospective arm)
2. Patients who underwent RHC in the past and were diagnosed with PHTN (retrospective arm)

Study endpoint:

1. Comparison of pulmonary blood pressures at rest, following vasodilator medication and following upper extremities exercise as measured by RHC and by the LDS during the Valsalva maneuver.
2. Determining LDS characteristics of PHTN patients

Eligibility Criteria:
Inclusion Criteria:

1. Prospective arm:

   * Man or woman aged over 18.
   * With suspicion or diagnosis of pulmonary hypertension.
   * Scheduled to undergo right heart catheterization
   * Able and willing to give informed consent.
2. Retrospective arm:

   * Man or woman aged over 18.
   * With diagnosis of pulmonary hypertension confirmed by right heart catheterization in the past.
   * Able and willing to give informed consent.

Exclusion Criteria:

1. Both arms:

   * Minor (aged \< 18).
   * People unable or unwilling to give informed consent.
   * Hemodynamically unstable patients.
   * Pregnant women.
2. Prospective arm only:

   * Patients with contra-indication to right heart catheterization.
   * Patients incapable of performing a Valsalva maneuver.
   * Patients with recent myocardial infarction, high degree AV block, severe aortic stenosis or glaucoma
Association Between Knee Isokinetic Testing and Lower Limb Functional Performance and Limb Symmetry

This study aimed to evaluate the association between the isokinetic knee strength and/or proprioception performance with the functional performance on the functional Hop-tests and Y-balance test.

This study included 20 healthy individuals who performed an isokinetic assessment of knee proprioception (joint position sense, JPS and threshold to detection of passive motion, TDPM) and flexors/extensors strength. At the same time, they performed a functional testing consisting of three Hop-tests (single, triple and cross-over) and the Lower Quarter Y-Balance Test (YBT-LQ). We tested the correlation between the isokinetic and functional performances, and limb symmetry indexes.


Eligibility Criteria:
Inclusion Criteria:

* individuals under 45 years of age who performed at least 4 hours of physical activity per week.

Exclusion Criteria:

* individuals unable to perform isokinetic muscle tests
* individuals with a current or recent lower limb injury with time loss from sport participation within the previous month
* individuals with previous severe knee injury (eg. Severe ligament tear, knee fracture)
* individuals taking medications with potential balance/coordination side effects.
A Trial of Trametinib and Panitumumab in RAS/RAF Wild Type Advanced Colorectal Cancer

This is a phase 2 study (the second phase in testing a new drug or drug combination) to see how useful the combination of two drugs, panitumumab and trametinib, are in patients with advanced colorectal cancer with KRAS, NRAS, or BRAF wild type (genes that are not mutated).

Panitumumab is a drug that is approved by Health Canada for the treatment of advanced colorectal cancer with KRAS wild type. Panitumumab works by binding to and blocking the protein, epidermal growth factor receptor (EGFR) from working.

Trametinib is a drug that is approved by Health Canada for the treatment of melanoma with a mutation in the BRAF gene. Trametinib works by binding to and blocking mitogen-activated protein kinase kinase (MEK) 1 and MEK2 from working.

Previous studies have shown that the combination of panitumumab and trametinib may be more useful in KRAS, NRAS, or BRAF wild type colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* KRAS/NRAS/BRAF wild type colorectal cancer, not responsive to standard therapies, no approved or curative therapy, refuse standard therapy
* Prior 5-FU, oxaliplatin and irinotecan
* ECOG Performance Status of 0 or 1
* Able to swallow/retain oral drugs
* Able and agree to have provide tumor tissue/have biopsies
* Agree to use contraception
* Not pregnant
* Adequate organ system function

Exclusion Criteria:

* Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapies \<28 days or 5 half lives
* Prior EGFR, MEK, or RAF inhibitor or regorafenib
* Current use of prohibited medications
* Unresolved side effects
* GI disease or other condition affecting GI absorption
* Mucosal or internal bleeding
* Any major surgery \<four weeks
* HIV, HBV, or HCV positive
* Active infection
* Leptomeningeal disease
* Brain metastases
* Unacceptable QTcF interval
* Significant uncontrolled arrhythmias
* Acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting \< 6 mos.
* Class II, III, or IV heart failure
* Other clinically significant ECGs
* Intra - cardiac defibrillators
* Cardiac metastases
* Condition that may interfere with patient safety
* Hypersensitivity to study drugs
* Severe or uncontrolled systemic diseases
* Pregnant or lactating
* Retinal vein occlusion
* Interstitial lung disease or pneumonitis
* Active liver or biliary disease
A Follow-up Comparison of Active Versus Passive Manual Therapy in Patients With Low Back Pain

To determine if there is any carry over difference between the type of education provided about common treatment techniques for patients with low back pain. This will be looked at right after treatment and when patients return on their second visit after they do a common exercise program for a few days.

Prior clinical trials have shown that patients respond differently to different explanations about interventions performed. A recent randomized clinical trial demonstrated that a 10-minute manual therapy treatment (prone lumbar Posterior to Anterior mobilization (PA's) with a neuroplasticity vs. traditional biomechanical explanation) produced an immediate, significant improvement in straight leg raise (SLR) and pain for patients with chronic low back pain. However, there is a need to examine whether there is any carry over (48-96 hours) or if utilizing a home exercise program (HEP), aimed at increasing the various sensory process applied in the clinic, produces any carry over. This will be looked at in patients with who are provided different explanations about common back treatment techniques to see if there will be any change in pain rating or back and leg movement.

Eligibility Criteria:
Inclusion Criteria:

* adults over the age of 18
* patients presenting at PT with a primary complaint of LBP
* LBP being present for 6 months or more
* fluent in English
* willing to participate in the study.

Exclusion Criteria:

* under age 18
* not able to read/understand the English language
* prisoners
* no medical issues precluding physical therapy treatment (red flags)
* no medical precautions to the use of manual therapy (metal, skin lesions, etc.)
* prior spine surgery
* unable to lay prone for the treatment
Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

This study will test the effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

Binge eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Participated in acute treatment for binge-eating disorder and obesity;
* Had a positive response to acute treatment;
* Available for the duration of the treatment and follow-up (20 months);
* Read, comprehend, and write English at a sufficient level to complete study-related materials; and
* Able to travel to study location (New Haven, CT) for monthly visits.

Exclusion Criteria:

* Currently taking anti-depressant medications;
* Currently taking opioid pain medications or drugs;
* Currently taking medications that influence eating/weight;
* History of seizures;
* Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
* Past or current anorexia nervosa, bulimia nervosa;
* Pregnant or breastfeeding;
* Medical status judged by study physician as contraindication.
Prospective Multicenter Clinical Study of Neoadjuvant Imatinib Mesylate for Gastrointestinal Stromal Tumors

The R0 resection rate of gastrointestinal stromal tumor (GIST) with high recurrence risk was relatively low, and the relapse-free survival rate was relatively low, which needed to be further improved. A few retrospective analyses and a small sample of prospective studies have found that neoadjuvant therapy with imatinib mesylate can improve R0 resection rates. Whether neoadjuvant therapy prolongs long-term survival remains unclear. The primary objective of this study was to evaluate 5-year progression-free survival (PFS) for GIST patients with high recurrence risk after neoadjuvant treatment with imatinib mesylate.


Eligibility Criteria:
Inclusion Criteria:

* Preoperative histologically confirmed primary gastrointestinal stromal tumor
* Tumor must stain positive for c-Kit (CD117) and/or discovered on gist-1 (DOG-1) by immunohistochemistry
* Gene mutation test report including c-kit exons 9,11,13 and 17 and platelet-derived growth factor receptor alpha (PDGFRA) exons 12 and 18
* High risk GIST (as modified National Institutes of Health (NIH) 2008): stomach (maximum tumor diameter\> 10.0cm), nonstomach (maximum tumor diameter\> 5.0cm)
* Gender is not limited. Age: ≥ 18 years and ≤ 80 years old
* Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1
* Patient had informed consent and signed a written consent form

Exclusion Criteria:

* Asp842Val (D842V) mutation in Exon 18 of PDGFRA gene, or wild type (c-kit exon 9,11,13,17, and PDGFRA Exon 12,18), or c-kit exon 9 mutation
* Treated with tyrosine kinase inhibitors including Imatinib
* Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)\>2.5×ULN(upper limit of normal)，or Total bilirubin (TBIL)\>1.5×ULN，or Creatinine (Cr)\>1.0×ULN
* Absolute neutrophil count (ANC) \< 1.5 × 10 \^ 9 / L；or Platelet count (PLT) \< 75 × 10 \^ 9 / L；or Hemoglobin (Hb) ≥ 90 g / L
* Previous or concurrent other active malignant tumors (except for basal cell carcinoma of the skin, or cervical cancer in situ that has undergone curative therapy)
* Distant metastases are present
* Any of the following conditions during the 12 months prior to entry: myocardial infarction, severe / unstable angina, coronary artery / peripheral artery bypass surgery, symptomatic congestive heart failure, or cerebrovascular accidents
* positive Human Immunodeficiency Virus (HIV) antibody
* Currently participating in other clinical trials
* Pregnant or lactating women or have fertility without taking contraception
* Suffering from other serious acute and chronic physical or mental problems, or abnormal laboratory tests, will increase the risk of participation or drug use, or interfere with the judgment of the findings, judged by the researchers as participate in the study