cyrilzakka/clinical-trials huggingface dataset:
Acute Kidney Attack in Severe Traumatized Patients

Acute Kidney Injury (AKI) is a common complication of severe traumatized patients. The diagnosis is often delayed. The Nephrocheck® test allows an earlier assessment of renal stress. The objective of our study is to determine the incidence of risk of AKI in severe traumatized patients within the first 24 hours after their admission to our trauma center. The risk of AKI is defined by a NephroCheck® test \>0.3


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* trauma patients with ISS ≥15
* patient admitted to the resuscitation bay of Edouard Herriot Hospital

Exclusion Criteria:

* anuric patient
* opposition of the patient (or a trusted person) to participate
* pregnant or lactating woman
* age \<18 years
Systematic Analysis of a Standardized Questionnaire to Detect Possible Bleeding Disorders and Its Impact on Perioperative Hemostasis Management

With the help of a standardized questionnaire, an increased risk of bleeding due to pre-existing hemostasis disorders in the site-specific patient population will be detected and the corresponding enhanced diagnostic measures will be initiated. The planned prospective observational study should i.) systematically investigate the results of this procedure and ii.) allow a comparison with a retrospective perioperative cohort that was cared for at the Benjamin Franklin Campus before the introduction of the questionnaire. Due to the campus structure with a large vascular surgery center as well as a large urological, general and trauma surgery department, a high number of multimorbid patients with pre-existing disorders of primary hemostasis, mainly caused by medication or secondary diseases, is to be expected.

In the following, the feasibility of the required measures in clinical routine (measured by the frequency of actual changes or modifications of the initially planned perioperative procedure, the adequate implementation of indicated diagnostic measures, etc.) will be examined.

The aim of the study is the systematic scientific evaluation of a standardized questionnaire for bleeding history already used in clinical routine during the preoperative anesthesiological visit and its impact on perioperative coagulation management.

The routine use of a standardized questionnaire to assess bleeding risk is based on a study on the preoperative identification of patients with (primary) hemostasis disorders from 2007: in a patient collective of 5649 patients from different disciplines at the Charité - Universitätsmedizin Berlin, a positive predictive value of 99% for the presence of a hemostasis disorder could be established if at least four questions of a standardized bleeding history questionnaire were answered positively. This is not possible in the same way with the plasmatic coagulation-global tests established in clinical routine.

The standardized application of the questionnaire serves to identify patients at risk of bleeding at an early stage and to adapt and optimize perioperative coagulation management accordingly by initiating targeted diagnostics and therapy. However, a systematic scientific evaluation of this questionnaire with regard to the conditions at the Benjamin Franklin Campus with a large vascular surgery center as well as a large urological, general and trauma surgery department and a high number of multimorbid patients with pre-existing disorders of primary hemostasis, mainly caused by medication or secondary diseases, is still pending.

Eligibility Criteria:
Inclusion Criteria:

All adult (age ≥ 18 years) patients of both genders undergoing elective surgery at the Benjamin Franklin campus in the 12-month period

Exclusion Criteria:

* Pregnancy, lactation
* Patients not capable of giving consent
* Already diagnosed hemostasis disorder
* Patients under (plasmatic) anticoagulation
Study Evaluating Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

The purpose of this study is to investigate the incidence of adverse events for patients with AS treated with Enbrel in usual care settings.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ankylosing spondylitis

Exclusion Criteria:

* Contraindications according SmPC
Study of Tirofiban Administration in Patients With Aspirin and or Clopidogrel Resistance

This study will evaluate whether adding tirofiban, administered at high bolus dose on top of aspirin and clopidogrel will lead to a lower rate of periprocedural myocardial infarction after percutaneous coronary intervention in elective patients presenting with aspirin and/or clopidogrel resistance.

This study will investigate the effect of treatment with a high bolus dosage of Tirofiban (in addition to Aspirin, Heparin and 300mg or 600mg clopidogrel) on the rate of periprocedural myocardial infarction compared to Aspirin, Heparin (or bivalirudin) and 300mg or 600mg clopidogrel alone in patients resistant to aspirin and/or to clopidogrel.

This is a randomized, double blind, placebo controlled (with bailout tirofiban as rescue) multicenter study. Enrollment will last between 12 and 36 months depending on the final number of participating centres. The minimum follow-up will be 30 days after the index procedure.

Eligibility Criteria:
Inclusion Criteria:

1. All Patients older than 18 years scheduled for coronary angiography and/or PCI will be enrolled. \[Patients should be CK-MB negative (to avoid CK washout with revascularization) and also cTnI/T negative whereas other high-risk features will not lead to patient exclusion.
2. All consecutive patients with stable or unstable troponin and CK-MB negative coronary artery disease showing aspirin and or clopidogrel resistance (ACR) will be enrolled. These include:

   * Patients with clinical indication to undergo angiography for possible revascularisation.
   * Patients with ACR in whom catheter-based coronary intervention is planned based on previous angiogram.

Exclusion Criteria:

1. Patients who can not give informed consent or have a life expectancy of \< 1 year
2. Evolving or Ongoing myocardial infarction (MI) (Persistence of or developing Q wave or ST segment elevation at ECG with or without typical chest pain or typical rapid rise and fall CK-MB or new LBBB) or patients in whom the treating physician intends to use a Gp IIB/IIIa inhibitors.
3. Administration of any GP IIb/IIIa receptor antagonist, anticoagulation, or lytic therapy in the previous 30 days
4. Serum creatinine more than 2.5 mg/dl (221 micromol/L)
5. Ongoing bleeding or bleeding diathesis or contraindication for anticoagulation or increase bleeding risk or history of bleeding in the last 1 year
6. Previous stroke or TIA or any intracranial pathology in the last six months
7. Major surgery or trauma within the previous six weeks
8. Platelet count \< 100.000 per cubic mm or HCT ,33% or Hb \< 11 gm/dL
9. Subjects who received low-molecular-weight heparin within the 24 hours prior to randomization
10. Subjects with an allergy or intolerance to aspirin, heparin, clopidogrel, or tirofiban
11. Patients with severe hypertension (SBP \> 180 mm Hg or DBP \> 110 mm Hg) or in cardiogenic shock (SBP 80 mm Hg or below for \> 30 minutes) or requiring IABP
Study of Weekly Motexafin Gadolinium (MGd) for Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

The primary purpose of this study is to evaluate the safety, toxicities, dosage and response rate for an investigational drug, motexafin gadolinium, administered to patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. The secondary purpose of this study is to evaluate the clinical benefit rate, the time it takes for a patient's chronic lymphocytic leukemia or small lymphocytic lymphoma to worsen, the duration of response and the time during which patients survive without chronic lymphocytic leukemia or small lymphocytic lymphoma worsening. Additionally, the patient's response to motexafin gadolinium will be compared to the response of the patient's cells in a laboratory to motexafin gadolinium.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* CLL as defined by the NCI 96 criteria (exception; patients may have bright surface immunoglobulin staining if negative for t\[11;14\] translocation or cyclin D1) or SLL as defined by WHO classification criteria and is refractory or relapsed as defined by one of the following:

  * Refractory disease: progressive disease while on therapy
  * Relapsed disease: progressive disease after at least one treatment course of therapy with disease response or stabilization
* ECOG performance status score of 0, 1, or 2
* Willing and able to provide written informed consent

Exclusion Criteria:

* Laboratory values of:

  * Platelet count \< 30,000/µL
  * AST or ALT \> 2 x ULN (upper limit of normal)
  * Total bilirubin \> 2 x ULN
  * Creatinine \> 2 mg/dL
* Chemotherapy, radiation therapy, immunotherapy, systemic corticosteroids (\> 10 mg oral prednisone or equivalent), or systemic biologic anticancer therapy within 21 days before beginning study treatment
* Major surgery or hospitalization for a serious illness within the last 3 months
* Greater than three prior regimens (where a regimen is defined as a treatment for CLL/SLL given initially or after disease progression)
* Prior malignancy requiring current or prior treatment within the past 5 years, except for cervical neoplasia in situ and non-melanomatous skin cancer
* Uncontrolled hypertension
Dexmedetomidine for Sedation During Radiological Interventional Procedures

Evaluation of the role of dexmedetomidine as a sole agent in sedating patients undergoing interventional radiological procedures and measuring its different outcome variables.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18-65 years old
* ASA physical status of I-II
* Expected procedure lasting at least 30 minutes

Exclusion Criteria:

* Unstable cardiac status (life-threatening arrhythmias, abnormal cardiac anatomy, significant cardiac dysfunction and third-degree heart block.
* An alpha2-agonist or antagonist within 14 days before the scheduled procedure.
* patients received an IV opioid within 1 h, or an oral or IM opioid within 4 h of the start of study drug administration.
* Patients who are allergic to Dexmedetomidine or alpha 2-agonists.
Playmaker 3D Printed Knee Extender

The purpose of this study is to explore the development of, and patient outcomes associated with, the use of individually printed knee extender in conjunction with a video-based home pre-habilitation program for patients who have suffered an ACL rupture before surgery.

The proposed study will assess the efficacy of utilizing desktop 3DP for patient-specific knee extenders paired with a video-based home pre-habilitation program to address the aforementioned barriers. If the novel device and home program is found to be a viable treatment option, this may improve or replace current treatments for knee pre-habilitation, increase accessibility to proper treatment, and reduce cost and time burden on patients, PTs, and providers. The study will offer a greater understanding of potential improvements to clinical workflows and efficiencies through using 3DP. This technology is an under- utilized resource; further research into the applications of 3DP in the field of orthopaedics will provide opportunities to improve patient care and outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 14-60 years old patients who have suffered an isolated primary ACL rupture

Exclusion Criteria:

* Patients who have already attained full knee extension
* Open skin wounds that would come into contact with the device
* Pregnant women
Description of Tolerability of LCZ696 (Sacubitril / Valsartan) in Heart Failure With Reduced Ejection Fraction (HFrEF) Treated in Real Life Setting

The primary purpose of the study was to describe the tolerability of treatment with the optimal dose of LCZ696 (97 mg sacubitril / 103 mg valsartan bid), over six (6) months, in patients with heart failure with reduced ejection fraction (HFrEF) in Canada.

The study was also to describe the overall tolerability, effectiveness and safety of LCZ696 for the management of HFrEF over 12 months of treatment, as well as describe the patterns of LCZ696 up and down dose titrations occurring during the management of patients with HFrEF.


Eligibility Criteria:
Key Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed.
2. Age ≥ 18 years and ≤ 80 years.
3. Males or females.
4. Diagnosis of Heart Failure NYHA class II-III.
5. Diagnosis of Heart Failure with reduced Ejection Fraction (LVEF =\< 40%) and NYHA class II or III.
6. Stable on any dose of ACEI or ARB prior to enrolment in the study
7. Stable on any dose of a beta-blocker prior to enrolment in the study.
8. Eligible for treatment with LCZ696 as per Canadian product monograph.
9. Treated as an outpatient.
10. Signed an informed consent agreeing to participate in the study.

Key Exclusion Criteria:

1. Symptomatic hypotension and/or a SBP \< 100 mmHg at baseline visit.
2. Estimated GFR \< 30 mL/min/1.73m\^2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at baseline visit.
3. Known history of angioedema related to previous ACEI or ARBs therapy, or history of hereditary or idiopathic angioedema.
4. Requirement of concomitant treatment with both ACEIs and ARBs.
5. Concurrent participation in other clinical trials or receiving other investigational drugs within 30 days of enrollment.
6. Hypersensitivity to the active substances, sacubitril or valsartan, or to any of the excipients.
7. Concomitant use of aliskiren-containing drugs in patients with diabetes mellitus (type 1 or type 2) or moderate to severe renal impairment (GFR \<60ml/min/1.73m\^2).
8. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
9. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
10. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
11. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods are described in the protocol.
This is the Comparison of Clinical Effectiveness of Hydrochloric Acid-pumice Compound and Sodium Hypochlorite-pumice Compound Used in Microabrasion Technique for the Treatment of Dental Fluorosis. Change in Tooth Shade Was Checked Before and After the Procedure.

To compare the clinical effectiveness of hydrochloric acid-pumice compound and sodium hypochlorite-pumice compound in treating dental fluorosis using microabrasion technique.

A Randomized Clinical Trial was taken Fatima Jinnah Dental College Hospital, Karachi, from 1st November 2019 To 30th April 2020. Total 30 teeth in each group were included. Preoperatively shade was checked. The mixture was applied 10 times or more during the same session. Total treatment time was around 30 minutes. Every patient received entire microabrasion treatment. At the end of the treatment, neutral sodium fluoride gel was applied. Then changes in shade were checked. Descriptive statistics were calculated.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-40 years .
* Permanent dentition assessed on clinical examination.
* Have at least four maxillary incisors with scores of 4 to 5, according to the Dean's Fluorosis Index.
* Have no caries or restoration on the teeth to be treated assessed clinically.

Exclusion Criteria:

* Poor oral dental and general health assessed on clinical examination.
* History of Smoking and any form of tobacco.
* Patients with periodontal disease assessed on clinical examination.
* Caries on anterior teeth assessed on clinical examination.
* Hypersensitive teeth assessed on clinical examination.
The Effect of Exercise on Physical Function in Older Women With Osteoporosis and a History of Vertebral Fracture

The study is a parallel-group single blinded randomized controlled trial, examining the effect of exercise on physical function in older women with osteoporosis and a history of vertebral fracture. The participants will randomly be assigned in a 1:1 ratio to the intervention group and the control group. The intervention will follow newly developed exercise recommendations for people with osteoporosis and vertebral fractures, which states the balance- and strength exercises should be performed at least twice a week. The intervention is a group exercise session circuit program lasting for 12 weeks. The participants will be tested at baseline, and followed up at 3 months and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Women over 65 years, living at home, able to walk with or without walking aids
* having osteoporosis verified by DXA scan (-2,5)
* at least one vertebral fracture, verified by X-ray

Exclusion Criteria:

* Health conditions that make it unsafe to exercise
* not able to understand and speak Norwegian adequately to participate in the intervention
Virtual Management of Rheumatoid Arthritis

The purpose of this study is to optimize the care of patients with RA seen in virtual consultation.

This study will be organized in two consecutive steps:

1. A first descriptive step that will consist of a retrospective analysis of virtual consultation records of patients with RA during the pandemic and lockdown period in order to analyze on which criteria the patients were assessed and followed during this period.
2. The second step will consist in evaluating the interest of the systematic use in virtual consultation of a patient reported outcome (PRO), the RAID (Rheumatoid Arthritis Impact of Disease) questionnaire; and analyze how its results influence the rheumatologist decision-making.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatoid arthritis fulfilling the 2010 ACR/EULAR classification criteria
* Follow-up in the rheumatology department of Cochin Hospital
* Affiliated with a social security scheme
* Non-opposition to participating in the study
* Patients with a valid email address (registration to the virtual consultation system)

Exclusion Criteria:

* Opposition to participate to this research
* Inability to understand or speak French
* Patient under tutor or curator ship
* patients under medical state help
A Comparison of Laparoscopic With Open Distal Gastrectomy in Advanced Gastric Cancer After Neoadjuvant Chemotherapy

The purpose of the study is to evaluate the safety and efficacy of laparoscopic distal D2 gastrectomy (LDG) compared with open surgery (ODG) for resectable gastric cancer, to determine whether LDG can be a test arm for a future Phase III trial to evaluate the non-inferiority of overall survival compared with ODG in patients who receive neoadjuvant chemotherapy.

The study is an open-label, controlled, randomized Phase II clinical trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital.

The primary endpoint is the 3-year progression-free survival (PFS) rate. The secondary endpoints are the overall survival, surgical morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of the stomach.
* Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and laparoscopy. The T and N stages are determined by the method of Habermann et al.
* The gastric tumors are located in the middle to lower third of the stomach, are macroscopically resectable by distal gastrectomy with D2 lymph node dissection, and R0 or R1 resection can be achieved.
* No bulky lymph node metastasis is detected by abdominal CT.
* No pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic CT.
* No clinically apparent distant metastasis.
* Karnofsky performance status ≥70%.
* Sufficient oral intake.
* No previous treatment with chemotherapy or radiation therapy for any tumors.
* No previous surgery for the present disease.
* Sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. When patients are recovering from myelosuppression,the revised criteria are shown in parentheses.

White blood cell count≥3000/mm3 (2000/mm3) Platelet count≥10.0\*104/mm3 (5.0\*104/mm3) Aspartate aminotransferase≤100 IU/l Alanine aminotransferase≤100 IU/l Total bilirubin≤2.0 mg/dl Serum creatinine≤1.5 mg/dl

* No need for emergency surgery due to bleeding or perforation of the primary tumor.
* No mechanical obstruction.
* Written informed consent.

Exclusion Criteria:

* Past history of upper abdominal surgery.
* Past history of surgery for the gastrointestinal tract.
* Body mass index exceeding 30 kg/m2.
Sight and Hearing Investigation Into Effects on Delirium

The goal of this observational study is to learn about sensory loss in hospital patients with delirium. The main questions it aims to answer are:

* Are hearing and vision loss related to increased risk of having delirium?
* Do hearing and vision loss contribute to more severe delirium?
* Do sensory loss and/or delirium affect patient satisfaction with hospital care?

Participants will be asked to:

* answer delirium screening questions,
* undergo hearing \& vision screenings, and
* complete questionnaires about the hospital stay.

The second part of this study is a clinical trial. Researchers will compare different hospital units to see if changing communication affects the number of patients with delirium. The main questions it aims to answer are:

• Does sharing information about communication and/or providing hearing devices change the number of hospital patients with delirium?

Participants in the study will be asked to complete delirium screenings and answer questions about their hearing and communication.

This is a prospective cohort study entitled Sight \& Hearing Investigation into Effects on Delirium (SHIELD), which aims of to characterize the impact of sensory impairment (i.e., vision and/or hearing loss) on inpatient delirium and experience. The initial phase of this research includes delirium, hearing, and vision screenings, as well as questionnaires regarding satisfaction with care, all of which are observational and do not constitute treatment or intervention. Researchers will conduct electronic medical record reviews to determine whether new patients have been admitted to the units of recruitment on a daily basis and collect relevant demographic and medical information. Eligible patients will be screened to with the 4AT identify delirium and the 3D-CAM-S to characterize delirium severity. After obtaining informed consent, patients will undergo bedside hearing and vision screenings, and complete patient satisfaction questionnaires.

The second phase of present study aims to determine the impact of improving communication on delirium in the hospital setting. Screenings will be used to identify delirium and measure severity and patients will be asked to report subjective hearing difficulty. Subsequent intervention will involve addressing communication barriers posed by hearing loss by providing training to clinical nursing staff, reinforcing strategies for effective communication through the use of posted signs, and providing amplification devices to eligible patients.

Eligibility Criteria:
Inclusion Criteria:

* inpatient on Johns Hopkins Bayview Medicine A, Medicine B, or Carol Ball unit
* communicates using speech and language
* able to converse in English

Exclusion Criteria:

* nonverbal
* unable to communicate using English language
* currently under airborne or droplet isolation precautions