cyrilzakka/clinical-trials huggingface dataset:
Management of Combined Fracture Neck of Femur and Femoral Deformity in Osteogenesis Imperfecta Patient

O.I with NOF fixed by Wagner technique and telescoping nail

osteogenesis imperfecta (Sillence Type IV) sustained neck of femur fracture after fall on ground. He had proximal femoral anterolateral bowing on top of inserted rod 4 years ago. He was treated with corrective osteotomy and intramedullary telescoping nail for deformed femur and Wagner technique to fix NOF fracture. One year after operation the patient gained satisfactory functional outcome with union of NOF fracture and correction of femoral deformity. This rare case illustrates the anticipated difficulties in managing neck of femur fracture in osteogenesis imperfect patients. The method of fixation with Wagner technique can achieve stable fixation for solid healing in fragility fractures like this and the least interference with telescoping nail insertion.

Eligibility Criteria:
Inclusion Criteria:

* OI

Exclusion Criteria:

* Not receiving Bisphosphonate
New Prognostic Kidney Function Markers in Emergency Patients New Markers of Kidney Function in ED Patients

NephroCheck is measuring the concentration of a certain protein combination in the urine of patients. In elevated values there is a probability of renal failure (already proven in intensive care patients). The investigators would like to investigate whether the investigators can predict renal failure in patients receiving contrast enhanced CT's in the emergency department. That would lead to an earlier nephrologist consult in those patients.

The use of contrast agents can - especially in already in impaired renal function - lead to a decline in real function. The contrast enhanced CT is especially in emergency patients an important diagnostic tool for example in the detection of pulmonary embolism or mesenteric ischemia. Creatinine has been used as a marker for real function so far. But the investigators all know that creatinine is not a perfect marker especially as it is influenced by age, sex, weight and muscle mass. Especially in the diagnosis of acute renal failure creatinine does not allow and recent change in the kidney function.

This prospective, unicentric study should therefore investigate two new markers in emergency patients who need an emergency contrast enhanced CT to early predict pending kidney function decline.

Eligibility Criteria:
Inclusion Criteria:

* patients in the emergency department who have the indication for contrast enhanced CT and a predicted hospital admission time of 48 hours or longer.

Exclusion Criteria:

* children, pregnant women
* dialysis
* patients with kidney transplants
* patients on steroids or further immunocompromised
CHOEP + High Dose Therapy + Auto SCT for T-Cell Lymphoma

The current standard of care for the frontline treatment of peripheral T-cell lymphomas (PTCL) is induction chemotherapy followed by autologous stem cell transplantation (ASCT). However, many patients are unable to get to ASCT or relapse after ASCT, with a poor prognosis. Recently, a novel ASCT conditioning regimen of gemcitabine, busulfan and melphalan (Gem/Bu/Mel) has been reported to lead to favorable outcomes in this disease. We therefore designed a frontline regimen of CHOEP induction followed by Gem/Bu/Mel ASCT, and report the results of a phase 2 study of this regimen in patients with PTCL.

Objectives:

Primary

* To estimate the proportion of patients alive and progression-free at 24 months after beginning induction therapy

Secondary

* To estimate the response rate (complete remission (CR) and partial remission (PR)) after CHOEP x 6 and after Gem/Bu/Mel ASCT
* To estimate overall survival (OS), progression-free survival (PFS), cumulative incidence of relapse (CIR), and non-relapse mortality (NRM)
* To estimate the toxicity (grade 3 and above)
* To estimate the rate of successful stem cell mobilization after CHOEP in responding patients
* To estimate the proportion of patients who can successfully complete the entire treatment regimen
* To estimate the time to engraftment of neutrophil and platelet engraftment after ASCT
* To determine whether tumor DNA can be detected in peripheral blood of patients before therapy
* To evaluate the changes and prognostic relevance in detectable tumor DNA in peripheral blood after induction chemotherapy (CHOEP) and after Gem/Bu/Mel ASCT

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of T-Cell lymphoma with mandatory pathologic review at Brigham and Women's Hospital or Massachusetts General Hospital
* Measurable disease
* Candidate for Autologous Stem Cell Transplant

Exclusion Criteria:

* Prior anti-lymphoma chemotherapy (except steroids/radiotherapy for urgent palliation, one prior cycle of CHOP or up to 2 prior cycles of CHOEP)
* Pregnant or breastfeeding
* Alk-positive ACL
* Significant neuropathy precluding vincristine administration
* Known hypersensitivity to any of the agents used in the treatment
* Uncontrolled intercurrent illness
* Receiving other investigational agents
* History of a different malignancy except if disease free for at least 5 years or have cervical cancer in situ or basal cell/squamous cell carcinoma of the skin
* HIV positive on anti-retroviral therapy
UltraSound Evaluation of Fluid tOleRanCE for Acute Kidney Injury

Fluid expansion with isotonic crystalloids is a first-line intervention in the treatment of patients with acute kidney injury (AKI). While it is generally accepted that the timely correction of kidney hypoperfusion will minimize the extent of injury as well as potentially facilitate recovery, there are potential harms involved in indiscriminate administration of intravenous fluids. Although anticipating fluid tolerance is part of the clinical evaluation of a patient for whom intravenous fluid therapy is considered, it has been suggested that using Point-Of-Care ultrasound (POCUS) may enable the early identification of patients with a high-risk of congestive complications and guide clinical decisions with greater precision\[1\]. However, it has not been shown that providing this information in the context of AKI result in a change in management or a prevention of complications.

This single-center pilot randomized controlled trial aim to determine the feasibility of comparing a management including a POCUS evaluation of fluid tolerance to usual care in non-critically ill patients with AKI. In the intervention group, a POCUS evaluation will be performed and interpreted by experienced staff producing a report that will be presented to the attending care team. This assessment will be repeated 48-72 hours later. The primary aim of the study will be to establish the feasibility of this intervention. Secondary objectives will include determining the difference between the intervention arm and the control arm in relationship with fluid administration, diuretic use, evolution of kidney function, and intensification of care.


Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥ 18 year-old
2. Admitted to the hospital
3. Acute kidney injury defined by the KDIGO criteria\[48\]
4. Fluid expansion is considered by attending nephrologist or already ongoing

Exclusion Criteria:

1. Admitted to the intensive care unit
2. Known stage 5 chronic kidney disease according to the KDIGO classification receiving renal replacement therapy or not.
3. Renal replacement therapy for AKI has been initiated or is planned within 24 hours
Measuring of Neuro-visual Functionality With Ocusweep

The aim of this study is to measure visual acuity, contrast sensitivity and visual field by SAP-method using a novel device Ocusweep compared to currently widely used methods. Addition to that, the aim is to validate a novel perimetry method (Visual Search Test, VST) which is based on reaction times in visual decision- making task, where the subject is allowed to move eyes and where the fixation is verified by the subject himself in contrast to standard automatic perimetry (SAP) where prolonged stationary fixation and external fixation monitoring apparatus is required. Reaction-time based visual field device Ocusweep is compared to generally used SAP methods. Those tests will be done for healthy volunteers and for persons with diagnosed eye or brain disease.

Ocusweep OcuRT vision based choice reaction time test is validated for test repeatability and compared to Trail Making Test (TMT), Useful Field of View (UFOV) and Vienna Test System (VTS) reaction time tests. To evaluate the ability to detect unreliable results, OcuRT test is also done under cognitive load and with instructions to cheat the test.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Persons suffering diagnosed eye disease
* Persons suffering diagnosed brain disease

Exclusion Criteria:

* No diabetes
* Only one diagnosed disease
Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes

The goal of this study is to assess the long-term efficacy and safety of Firebird2 Cobalt-Chromium（CoCr）-alloyed sirolimus-eluting stent in treatment of complex lesions in diabetes.

This clinical trial is an international multi-center prospective clinical registry research, for evaluating the efficacy and safety of Firebird 2 cobalt-chromium alloyed sirolimus-eluting stent in treatment of complex coronary lesions in diabetes. As planned, about 57 research centers all over China, Latin America and Asia-Pacific areas will be involved and, 1300 patients will be enrolled into this research. The implanted stents must all be Firebird2 cobalt-chromium alloyed sirolimus-eluting stent. The patient enrollment will last for 12 months. Clinical follow-up will be done respectively for 30 days, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. All quitted patients during the study will not be replaced with any substitutes, but categorized in the enrollment failure column. The researcher must state clear the reason of nonenrollment.

Eligibility Criteria:
Inclusion Criteria:

* Definitely diagnosed type 2 DM either before or during the current hospitalization and with complex coronary lesions
* The coronary lesion is complied with the definition of complex type. (defined by protocol)
* The investigator admitted patients which are suitable for implanting Firebird2 CoCr-alloyed Sirolimus-eluting stent(SES)
* Patient or his/ her legal supervisor are provided with informed consents.

Exclusion Criteria:

* Women during pregnancy and breast-feeding;
* ST-segment elevated MI occurred within 1 week;
* Graft lesion after the coronary artery bypass graft(CABG) operation;
* Patient with other brand of stent implanted;
* LVEF ≤ 35%;
* Renal insufficiency before operation (Serum creatinine ≥ 177umol/L)
* Impaired fasting glucose（6.0mmol/L～7.0mmol/L）or impaired glucose tolerance（OGTT 2h blood glucose 7.8mmol/L～11.1mmol/L）patient;
* Recent PCI within 6 months or previous intravascular radiotherapy;
* Predicted life span is less than 12 months;
* Patient allergic to the following materials: aspirin, heparin, Clopidogrel, CoCr alloy, contrast agent or sirolimus.
* Recent participation of trial medication or other device study without endpoints completion or it is clinically interfering FIRE2-DIABETES study endpoints.
* Considered by other investigators unsuitable for implanting Firebird2 CoCr-alloyed SES
* Patients could not obey the study rules, such as not understanding the study manner, scope or its outcome, not cooperative, not providing the informed consent, not accepting follow-up, not finishing the whole study procedure.
Subclinical Atherosclerosis Using Dual-source CT Coronary Angiography in Chinese Adults With Different Glycaemic Status

Part I: Survey of Coronary Artery Calcification and Stenosis in Participants with Different Glycaemic Status

Aims:

To evaluate coronary artery calcification and stenosis in community-dwelling adults with different glycaemic status, using dual-source CT angiography (CTA)

Study Subjects and Methods:

200 adults with normal glucose regulation (NGR), 200 with impaired glucose regulation (IGR) and 200 with type 2 diabetes were recruited from an urban community of Shanghai, who then underwent a comprehensive examination including questionnaire, anthropometric measurements, biochemical analysis and CTA.

Part II: Follow-up of Cardiovascular Events and Re-evaluation of Coronary Artery Calcification and Stenosis

Aims and Methods:

To investigate the development of cardiovascular diseases in subjects recruited in part I and re-evaluate coronary artery calcification and stenosis using CTA after 3-year follow-up

To identify the predictive value of coronary artery calcification and stenosis with future risks of cardiovascular diseases and the possible development of coronary artery disorders among participants with different glycaemic status


Eligibility Criteria:
Inclusion Criteria:

1. Age between 40 and 70 years old
2. Gender: males and females
3. Provide written informed consent
4. Satisfactory compliance

Exclusion Criteria:

1. History of cardiovascular diseases
2. Allergy to iodine
3. Exposure to radiation within last 3 months
4. ALT more than 100IU/L, or serum creatine more than 133μmol/l \[1.5mg/dl\] or GFR less than 60ml/min
5. Heart rate more than 100 bpm or severe arrhythmia
6. Malignancy, myocardial infection, acute hepatitis or other major diseases
Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery

The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group intervention is an effective clinical tool to move a person with SMI along in their journey of recovery. The primary outcome measurements of this study will be the participants' perceived level of empowerment, hope and optimism, knowledge of recovery, and life satisfaction. This kind of information would add to the current body of knowledge about how principles of recovery can be used in psychoeducational programs used by outpatient community mental health services.

ABSTRACT:

Objective: Adopting the principles of recovery into the mental health field has been a growing area for discussion at many different levels of care. The present study will determine if Spaniol and colleague's (1994) Recovery Workbook group intervention can be used as an effective clinical tool to move a person with a severe mental illness along in their journey of recovery. The primary outcome measurements of this study will be the participants' perceived level of empowerment, hope and optimism, knowledge of recovery, and life satisfaction. Method: The study will be a multicenter, prospective, single-blinded, randomized control trial. Sixty participants will be recruited from three Assertive Community Treatment Teams (ACTT) in Kingston, Ontario and individuals will be randomized to either the control or intervention arm of the study. The control arm of the study will receive their regular services from ACTT. The intervention arm will participate in a 10-week psychoeducational group program in addition to receiving their regular services from ACTT. Results: Analysis will be performed by intention to treat, based on total scores of four assessments which will be performed at the trial commencement and termination.

Eligibility Criteria:
Inclusion Criteria:

1. Receive support from an Assertive Community Treatment Team.
2. Meet the DSM-IV diagnostic classification for schizophrenia, schizoaffective, schizophreniform, delusional disorder, or bipolar disorder.
3. Aged 18-55 years-old.
4. Individuals agree to participate in the study after they have been informed of all the expected benefits and risks.
5. Neither substance misuse nor organic disorder judged to be the major cause of psychotic symptoms.

Exclusion Criteria:

1. Inability to give informed consent
2. Diagnosis of dementia
3. Significant head injury or other brain injury leading to cognitive impairment
4. Mental retardation (premorbid IQ \< 65)
5. Require an interpreter
Xenogeneic Collagen Matrix as an Alternative to Free Gingival Grafting for Oral Soft Tissue Augmentation

A split-mouth study comparing soft tissue augmentation results using free gingival graft (FGG) versus xenogeneic collagen matrix (CM) for the generation of keratinized tissue (KT) around teeth with insufficient (\< 2mm) KT.

A single-blind, randomized, controlled, split-mouth study of 30 subjects with insufficient zones of KT (\< 2mm). The study utilized a within subject treatment comparison design to establish non-inferiority of the test (CM) versus control (FGG) therapy. The primary efficacy endpoint was KT width at 6-months. Secondary endpoints included traditional periodontal measures, such as clinical attachment, recession and bleeding on probing. Patient reported pain, discomfort and esthetic satisfaction were also recorded. Biopsies were obtained at 6-months.

Eligibility Criteria:
Inclusion Criteria:

* At least two non-adjacent teeth in contralateral quadrants of the same jaw with \< 2mm of KT that requires soft tissue grafting (1-4 teeth may be treated). In case of adjacent teeth requiring grafting, only one tooth at each site will act as test or control tooth, but all teeth will get the same treatment). The number of teeth treated must be the same on the test and control sites.

  * Root coverage is not desired at the time of grafting.
  * Females of childbearing potential must have a documented negative urine pregnancy test.
  * Read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
  * Able and willing to follow study procedures and instructions.
  * Multi-rooted teeth may be treated but will not be included as study teeth

Exclusion Criteria:

* Vestibule depth of less than 7mm from base of recession, and/or teeth with Miller Grade 2 or higher mobility.

  * Any systemic conditions (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude periodontal surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
  * Presence of acute infectious lesions in the areas intended for surgery.
  * History of any tobacco use within the last six months.
  * Taking intramuscular or intravenous bisphosphonates.
  * Known hypersensitivity to collagen products, and/or allergy to iodine or shellfish.
  * Participating in other clinical studies involving therapeutic intervention (either medical or dental).
  * Previously undergone a gingival grafting procedure on the test or control teeth or the teeth adjacent to the study site.
  * Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration following entrance into the study.
  * Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Endodontics

The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.

In June 2016, an intranasal delivery system of local anesthesia called Kovanaze, gained FDA approval. \[9\] Kovanaze is available as a 0.2 ml metered spray and is intended to achieve pulpal anesthesia of 5 maxillary teeth on either side of the face.

With the ability to avoid the traditional painful injection Kovanaze offers promise in the field of maxillary anesthesia and this study intends to:

1. Compare Kovanaze to conventional needle anesthetic for procedures other than fillings and/or involving multiple teeth in adults
2. Evaluate patient anxiety, tolerance and acceptability of Kovanaze in patients undergoing dental procedures

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Class I or II
* Preoperative heart rate of 55 to 100 beats per minute
* Maximum blood pressure reading of 166/100 mmHg
* Treatment for a pathology in the maxillary anterior tooth or premolar that requires administering local anesthesia
* Adults (\>18 years) who require non-surgical root canal treatment in maxillary anterior teeth

Exclusion Criteria:

* Inadequately controlled thyroid disease
* Five or more nosebleeds in the past month
* Known allergy to any study drug or para-aminobenzoic acid
* History of methemoglobinemia
* Taking monoamine oxidase inhibitors, tricyclic antidepressants (i.e. amitriptyline), or non-selective beta adrenergic antagonists (i.e. propranolol);
* Taking oxymetazoline-containing products (i.e., Afrin) in the last 24 hours.
Femoral vs Radial Approach and MRI Evaluation of Strokes

Symptomatic cerebral infarction following cardiac catheterization is rare but silent brain injury could occur at an unexpectedly high rate. One study has found that up to 22% of patients with severe aortic stenosis who have undergone retrograde catheterization of the valve can be identified as having new ischemic lesions as detected by diffusion-weighted (DW) magnetic resonance imaging (MRI). During cardiac catheterization, cerebral microembolism as detected by TCD has frequently been observed, but whether it is clinically relevant remains unknown . However, recent studies have suggested that some of these microemboli could be responsible for acute brain injury, as documented by DW MRI.

Indeed the high sensitivity of DW MRI suggests that this technique could allow an improved estimate of cerebral ischemic events associated with cardiovascular-catheter procedures. We therefore decided to perform DW MRI before and after cardiac catheterization to prospectively assess both clinically silent and apparent cerebral embolisms for the first time in a multicenter trial. Furthermore, a randomization between radial and femoral access will allow assessment of risk of silent brain injury associated with the different vascular access sites.


Eligibility Criteria:
Inclusion Criteria:

* Patient with significant aortic valve stenosis before planned surgery.

Exclusion Criteria:

* Contraindication to MRI or inability to give written informed consent.
Understand the Association Between Peritoneal Dialysis Status and Gene Polymorphisms of VEGF and KDR

Peritoneal dialysis (PD) is an effective and successful way of renal replacement therapy. The initial transport status is related to distribution of blood vessels and micro inflammation state in peritoneum before PD. Vascular endothelial growth factor(VEGF) and its receptor, kinase insert domain containing receptor(KDR) may play important roles on initial transport status.

This study include 200 PD patients from Renji Hospital in Shanghai, China. According to the 4h D/P Cr within three months of starting PD therapy, we analyzed the association between the polymorphisms of VEGF and KDR and initial peritoneal transport property.


Eligibility Criteria:
Inclusion Criteria:

1. Patients are Han Chinese;
2. Patients prepare for dialysis in our center, and start PD within 3 months after abdominal catheterization;
3. Patients successfully complete the first peritoneal equilibration test(PET);
4. Follow up regularly in our PD center.

Exclusion Criteria:

1. Patients from hemodialysis to peritoneal dialysis;
2. Patients who need peritoneal dialysis due to transplant-renal loss;