cyrilzakka/clinical-trials huggingface dataset:
Impact of Three Body Positioning Strategies in the Drainage Fluids After Coronary Artery Bypass Surgery

To investigate different strategies of body positioning associated to early corporal mobilization and verify the impact int the time and quantification of thoracic and mediastinal drainage, pulmonary complications and time of intensive care units in hospitals stay. After first six hours post extubation in the first postoperative day and after evaluation and inclusion in the study, patients were randomized in three groups for receiving different strategies of body positioning associated to early mobilization with help of bed Hill Rom (Hill Rom Batesville@): Group 1: Control (GC n=33); Group 2: Continuous Lateral Rotation Group (TRCL n=34); Group 3:Positioning in sitting and Orthostatic (ORT n=34).

Coronary artery bypass surgery can lead to pulmonary complications like pleural effusion and pneumonia. These complications increase the length of stay and the immobility time. The investigators aim was to assess the impact of early mobilization of fluids drainage of chest tubes and the incidence of pulmonary complications. A prospective, randomized study included 101 patients divided in three groups. In the Control Group (CG:n=33) the patients were seated in armchair in the first 48 hours postoperative time. The Group (TRCL n=34) a Continuous Rotational Bed Therapy was instituted six hours post extubation in the first 24 hours and it comprised with by consecutive cycles of lateral rotation to the left and right side, and supine position with 30 seconds for pauses (using a Hill Rom Rotational Bed Device) witch stopped when need to perform routine measurements the hemodynamics measurements and clinical controls by nursing crew.The group ( ORT n=33) following the sequential steps T1: sitting in the bed for 2 hours, T2: sitting on the bed with their feet on the floor for 2 minutes and T3: the patients stoos up and walked on the spot for 2 minutes. Hemodynamics and oxygenation measurement before and after each intervention.

Eligibility Criteria:
Inclusion Criteria:

* first postoperative day of cardiovascular surgery 6 hours after extubation
* EFVE\> 35%
* writen inform consent

Exclusion Criteria:

* neurological alteration
* hemodynamics instability with PAM \< 60 mmHg
* blood
* pneumothorax or broncopleural
* arritymias
A Safety Study of GAMMAGARD LIQUID (GGL) in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

The main aim of this study is to evaluate the rates of adverse events of special interest (AESIs) (thrombotic events, acute kidney injury \[AKI\], and hemolytic events) among participants with CIDP initiating GGL compared with rates among participants with CIDP initiating comparator intravenous immunoglobulin (IVIG) products.

No study medicines will be provided to participants in this study.


Eligibility Criteria:
Inclusion Criteria:

* Have a minimum of 6 months of continuous enrollment in the study database with medical and pharmacy coverage before the index date. Gaps in continuous enrollment less than or equal to (\<=) 31 days are permitted.
* Fulfill the Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) diagnosis algorithm on or before the index date using all available baseline data for each participant.
* Additionally, to be eligible for the Ig-naive (new-to-class) cohort, participants will be required to meet the following inclusion criterion:
* Be free of any previous recorded use of any Ig product at any point before IVIG initiation.
* To be eligible for the Ig-experienced (new-to-drug) cohort, participants will be required to meet the following inclusion criterion:
* Have any previous recorded use of an Ig product at any point before the index date.

Exclusion Criteria:

* Having claims for greater than or equal to (\>=) 2 different IVIG products on the index date.
* Recorded diagnosis of any of the following conditions where Ig products are used for treatment on or before the index date

  1. Primary immunodeficiency disease (PID).
  2. Evidence of secondary immunodeficiency (SID), including hematological malignancy (e.g., diagnosis of multiple myeloma or chronic lymphocytic leukemia) or treatment with rituximab.
  3. Idiopathic thrombocytopenic purpura (ITP).
  4. Dermatomyositis or polymyositis.
  5. Systemic sclerosis/scleroderma.
  6. Myasthenia gravis.
PrevaLence of Albuminuria in Patients With CARdiovascular Disease and Type 2 Diabetes Mellitus in China: a National Cross-sectional Study

The association between Cardiovascular Disease (CVD) and Chronic Kidney Disease (CKD) is well established. Traditional risk factors for CVD and CKD are similar, with type 2 diabetes mellitus (T2DM) being the most prevalent risk factor. However, CKD is underdiagnosed and undertreated in patients with CVD. Further understanding of the combination of CKD in CVD patients is important to formulate prevention and treatment strategies for CVD patients and high-risk groups, reduce adverse events in CVD patients, and prevent progression of CKD to End Stage Renal Disease (ESRD).

The PLACARD study will include approximately 3,000 patients presenting to the cardiology department with type 2 diabetes and cardiovascular disease. The aim of this study was to assess the prevalence of proteinuria (urinary ACR) in type 2 diabetic patients with different cardiovascular diseases, both inpatient and outpatient in the cardiology departments of secondary and tertiary hospitals in China. Participants will be recruited at 30 clinical centers for a period of six months.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old;
* Diagnosed T2DM combined with ≥1 CVD (hypertension, coronary heart disease, atrial fibrillation, heart failure);
* During the data collection period, they went to the outpatient clinic of the cardiology department of the research center, or received treatment in the cardiology department;
* Ability to self-sign informed consent (electronic /paper).

Exclusion Criteria:

* Pregnant or lactating women;
* Dialysis patients;
* Other diseases that lead to elevated albuminuria, such as severe infection, confirmed primary glomerular disease, etc.;

  . Malignant tumors being treated (surgery, chemotherapy, radiotherapy or targeted therapy);
* Cachexia (CSS score ≥ 5 points);
* Severe liver disease (Child- Pugh grade C) ;
* Participated in an interventional clinical trial in the past three months.
Consolidation Chemotherapy for Locally Advanced Mid or Low Rectal Cancer After Neoadjuvant Concurrent Chemoradiotherapy

This trial is to assess the efficacy and feasibility of consolidation chemotherapy after neoadjuvant chemoradiotherapy for locally advanced mid or low rectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed adenocarcinoma of mid or low rectum
2. Locally advanced rectal cancer confirmed by image (i.e. Magnetic resonance image)

   * Clinical stage T1-3N1or2 on MRI
   * Clinical stage cT3N0 (or depth of perirectal invasion by tumor \>5mm on MRI)
   * Suspicious of circumferential invasion on MRI (or circumferential margin \<1mm)
3. ECOG performance status of 0-2
4. ASA grade ≤ 3
5. An informed consent has been signed by the patient

Exclusion Criteria:

1. Upper rectal cancer
2. Clinical stage T1or2N0 on MRI
3. Clinical stage T4Nany on MRI
4. Clinical stage TanyNanyM1 by image or histology
5. The patient received chemotherapy or radiotherapy during the past 6 months
6. The patient received any therapy for colorectal cancer or another malignancy during the past 5 years
7. The patient has severe underlying diseases or poor condition to receive chemotherapy or radiotherapy
8. Pregnant of breastfeeding women
9. The patient who participate in another clinical trial, or receives any drug for the trial
10. Uncontrolled peripheral neuropathy (more than grade 2)
11. Any unhealed wound, fracture, peptic ulcer, or intraabdominal abscess
12. Active gastrointestinal bleeding
13. Patients with an active infection, which needs antibiotic therapy, during the randomization period
GEN-001 Plus Pembrolizumab for Patients With Advanced Refractory Biliary Tract Cancer

This is a phase II, multicenter, open-label study with a safety run-in to evaluate the safety and efficacy of GEN-001 in combination with pembrolizumab or in combination with pembrolizumab and mFOLFOX for patients with advanced refractory BTC who have progressed after 1 or 2 prior standard therapy and are not candidates for any other standard therapy. The safety run-in phase will be conducted before the main study phase


Eligibility Criteria:
Inclusion Criteria:

* The patient (or legally acceptable representative if applicable) provides written informed consent for the trial.
* Be ≥19 years of age on day of signing informed consent.
* Patient with histologically or cytologically confirmed diagnosis of unresectable, recurrent, or metastatic advanced biliary tract adenocarcinoma of the gallbladder or biliary tree (either intrahepatic or extrahepatic cholangiocarcinoma)

Exclusion Criteria:

* A WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (Cohort 1 only), and was discontinued from the previous IO therapy due to a Grade 3 or higher immune-related AE (irAE) (Cohort 2 and Cohort 3).
* Is currently participating and receiving study treatments or has participated in a study of an investigational agent and received the study therapy or has used an investigational device within 4 weeks prior to the first dose of study treatment.
* Has had an allogeneic tissue/solid organ transplan
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.


Eligibility Criteria:
Inclusion Criteria:

* Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive.
* Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation)

Exclusion Criteria:

* Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive
* Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive
Femoral Triangle Block Versus Adductor Canal Block in Arthroscopic Anterior Cruciate Ligament Reconstruction

The aim of this study is to compare the postoperative analgesic effect of femoral triangle block (FTB) and adductor canal block (ACB)after arthroscopic anterior cruciate ligament (ACL) reconstruction.

The number of patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction has risen over the past decade. ACL reconstruction is associated with moderate to severe postoperative pain leading to hypertension, tachycardia, increased O2 demand, and myocardial stress.

Eligibility Criteria:
Inclusion Criteria:

* Age from 21 to 65 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I and II.
* Undergoing elective arthroscopic Anterior Cruciate Ligament (ACL) reconstruction.

Exclusion Criteria:

* Revisional surgery.
* Body mass index (BMI) \>35kg/m2.
* Coagulopathy.
* Infection at site of intervention.
* Hypersensitive to the study drugs.
* Chronic analgesic use.
* Neuromuscular disease.
* Drug abuse.
* Cognitive impairment.
A Phase I/II Dose Escalation Study Using Extracranial Stereotactic Radiosurgery to Control Pain

This study will evaluate pain control and quality of life in patients with paraspinal metastases, who have receive previous radiation therapy to these lesions, using single dose stereotactic radiotherapy.

The goal of the study is to determine the lowest dose of radiation that can be given to effectively control the tumor and provide effective pain relief.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18
* Prior non-hematogenous, histologically proven malignancy (specific exclusions are multiple myeloma and lymphoma)
* Pain attributable to one or two radiographically apparent metastatic lesion(s) amenable to ESRT
* Have had prior radiation to area of spine felt to be cause of patient's pain
* Zubrod performance status of 0-3
* Life expectancy of ≥ 3 months
* Signed informed consent prior to registration to study
* Radiographic evidence of stable disease outside of the spinal column for at least 6 weeks prior to study entry, as evaluated by pre-study imaging.

Exclusion Criteria:

* Women who are pregnant or nursing
* Either 'no evidence of other active cancerous disease' or 'other sites of known disease are locally controlled'
* No radiographic evidence of spinal instability (e.g. spinal cord compression requiring immediate surgical intervention)
* No initiation of chemotherapy within 15 days of trial entry.
* No plans for concomitant antineoplastic therapy (including standard fractionated RT, chemotherapy, biologic, vaccine therapy, or surgery) for at least 15 days following stereotactic radiosurgery.
* No active systemic infection.
* No evidence of myelopathy or cauda equina syndrome on clinical evaluation
AXIS 2: AX200 for the Treatment of Ischemic Stroke

The purpose of this study is to assess the efficacy of AX200 (filgrastim) in the treatment of acute ischemic stroke and to assess the safety and tolerability of AX200.


Eligibility Criteria:
Major Inclusion Criteria:

* diagnosis of acute ischemic stroke with an onset within 9 hours prior to start of study agent administration
* ischemic stroke in the MCA territory confirmed by MRI (diffusion)
* age ≥18 years and ≤85 years
* lesion size on DWI ≥15 ccm
* written informed consent

Major Exclusion Criteria:

* prior to current stroke: inability to walk or to lead an independent life
* life expectancy less or equal 6 months
* stupor or coma
* lacunar infarct
* any evidence of ICH
* malignant hypertension
* presence of history of active malignancies
* platelet count \<100/nl at randomization
* leukocyte count \>20/nl at randomization
* congenital neutropenia
* pregnant or lactating women
Interest of the Cone Beam Scanner of Temporal Bones in the Analysis of Conductive Hearing Loss

Conductive hearing loss is very common and the incidence increases with age. Until now, the scanner was the reference examination in the etiological diagnosis of deafness.

When performing a CT scan of temporal bones for the etiological diagnosis of conductive hearing loss, the quality of the image depends on the scanner brand and the acquisition parameters.

The investigators wish to show the usefulness of the cone beam in the diagnosis of conductive hearing loss


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject having performed a CT scan or a cone beam for pre- and post-operative conductive hearing loss between January 01, 2018 and December 31, 2020
* Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.

Exclusion Criteria:

* Subject who expressed their opposition to participating in the study
Carnitine Supplementation and Skeletal Muscle Mass

The primary aim of the current research project is to investigate the effect of carnitine supplementation on muscle strength and body composition.

A secondary aim of this project is to explore the effect of circulating trimethylamine N-oxide elevation, induced by carnitine supplementation on muscle strength and body composition.


Eligibility Criteria:
Inclusion Criteria:

* must be able to swallow tablets

Exclusion Criteria:

* cardiovascular disease
* liver disease
* kidney disease
* neuromuscular disease
* gastrointestinal disorders (including stomach ulcers and erosions)
* diabetes
* other severe chronic diseases
Whey Protein Supplementation in Cancer Patients

Nutritional derangements are very common in cancer patients and negatively affect survival, morbidity and quality of life. Intervention trials have demonstrated that nutritional counseling can improve energy balance, nutritional status and quality of life in patients undergoing chemo-radiotherapy. Oxidative stress plays a role in the tumor-cytotoxic effect of cancer chemotherapy and radiotherapy but may also play a role therapy-related adverse events such as an impairment of nutritional status and quality of life. The nutritional properties of whey protein have recently raised attention. In view of the high content in cysteine these proteins can positively stimulate the synthesis of glutathione which, in turn, could contribute to the modulation of whole-body and cellular redox state. However, evidence on the role of this dietary intervention in cancer patients is limited.


Eligibility Criteria:
Inclusion Criteria:

* Cancer patients (lung, gastric, pancreatic, breast, colon, esophageal)
* Eastern Cooperative Oncology Group performance status ≤ 2
* Weight loss \>= 10% in the last 6 months
* Chemotherapy
* Written informed consent

Exclusion Criteria:

* Age \< 18 years
* Ongoing artificial nutrition (enteral or parenteral)
* Unavailability to planned measurements
A Phase III Study Evaluating the Efficacy and Safety of Satavaptan Versus Placebo in Patients With Dilutional Hyponatremia

The primary objective of this study is to assess the efficacy of satavaptan versus placebo in participants with dilutional hyponatremia due to SIADH.

Secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and the clinical benefit in these participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants with symptomatic syndrome of inappropriate antidiuretic hormone secretion (SIADH) with chronic hyponatremia

Exclusion Criteria:

* Presence of clinical signs of hypovolemia (e.g. orthostatic decreases in blood pressure and increase in pulse rate, dry mucus membranes, decreased skin turgor)
* Presence of clinical signs of hypervolemia (e.g. generalized edema, jugular venous extension)
* Participants with adrenocortical insufficiency
* Participants with hypothyroidism
* Participants with known causes of transient SIADH
* Participants with psychogenic polydipsia or beer potomania
* Concomitant use of thiazide diuretics during the study
* Presence of uncontrolled diabetes with fasting blood glucose ≥200 mg/dL (≥11.09 mmol/L) at time of screening
* Participants with impaired hepatic function or liver cirrhosis (Child-Pugh A-C)
* Pregnant or breast-feeding women

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Novel Desensitization Kidney Transplantation

This proposal's objective is to determine whether belatacept, in conjunction with a proteasome inhibitor can be used to safely increase the likelihood of finding an acceptable donor for highly HLA sensitized kidney transplant candidates.

This is a pilot study to test the safety and effectiveness of the desensitization therapy with belatacept and proteasome inhibitor to increase the likelihood of of finding an acceptable donor for highly HLA sensitized kidney transplant candidates.

Eligibility Criteria:
Inclusion Criteria:

* Highly sensitized patient cPRA 99-100% AND actively listed for kidney transplantation at the kidney transplantation Program at University fo Chicago
* Ebstein Barr Virus (EBV) Immunoglobulins (IgG) seropositive
* No active systemic infection
* No allergy to proteasome inhibitors (Bortezomib), or to belatacept
* No known malignancy in the previous 2 years except for non-melanomatous skin cancer
* Female who agrees to practice 2 effective methods of contraception through 3 months after the last dose of Bortezomib
* Patient vaccinated against hepatitis B virus with positive level of HBsAb
* Patients fully vaccinated against Coronavirus Disease 2019 at least 2 weeks prior to the start of the 1st cycle.
* Actively listed for kidney transplant at the Transplant Institute at University of Chicago

Exclusion Criteria:

* Patient with significant neuropathy by the Common Terminology Criteria for Adverse Events (CTCAE) criteria within 14 days before enrollment (Grades 3-4 or Grade 2 with pain)
* Myocardial infarction within 6 months of enrollment or has Heart Failure in acute dialysis quality initiative (ADQI) ESRD classification system Class 2 non restrictive (2NR) or greater, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or ECG evidence of acute ischemia or active conduction system abnormalities
* Patient who received other investigational drugs within 14 days prior to initiation of study treatment
* Receipt of a live vaccine within 4 weeks prior to initiation of study treatment
* Evidence of severe liver disease by history or physical exam or with abnormal liver profile ( \> 1.5 times upper limit of normal within 30 days of consent)
* Female who is breast feeding or pregnant
* Untreated latent tuberculosis
* History of Post Transplant Lymphoproliferative Disease (PTLD)
* Patient still carrying previous kidney transplant.
50% Body Weight Reverses Stature, Lumbar Disc Expansion and Vertebral Compliance by Hyper-Buoyancy Floatation.

Study with the aim to see the effect on a space ground analogue , Hyper-Buoyancy Floatation (HBF) on lumbar column and the effect of a supplementary 50% of an axial load.

the aim of this study was to determine the effect of 15min of 1g reloading following 4h HBF unloading with, and without 30s of seated static 50% BW axial loading upon stature, lumbar Intervertebral Disc height (via ultrasound), vertebral compliance changes, and back pain.

Eligibility Criteria:
Inclusion Criteria:

* physical requirements (1.57-1.90m, 50-95kg)

Exclusion Criteria:

* current back/neck pain, musculoskeletal disorder, cardiovascular disease, spine surgery and being, or suspected to be pregnant
Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis

This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis


Eligibility Criteria:
Inclusion criteria

* Men or women of at least 18 years old or 20 years old in Japan.
* Stable maintenance of hemodialysis 3 times per week.
* Controlled serum phosphate if under phosphate-binder therapy.
* Serum phosphate level \> 6.0 mg/dL (\> 1.9 mmol/L) prior to study treatment initiation.

Exclusion criteria

* Peritoneal dialysis or a non-conventional hemodialysis technique .
* Parathyroidectomy or transplant scheduled during the study.
* Uncontrolled hyperparathyroidism
* History of hemochromatosis or ferritin \> 800 µg/L.
* Clinically significant GI disorder
* Unstable medical condition other than Chronic Kidney Disease.
* Treated with sevelamer HCl monotherapy or SBR759.
* Treated with oral iron.
* Other protocol-defined inclusion/exclusion criteria may apply.