cyrilzakka/clinical-trials huggingface dataset:
Does Joint Lavage Reduce Intraarticular Inflammation in High-energy Tibial Pilon Fractures?

High-energy tibial pilon fractures have historically been associated with poor outcomes largely due to the elevated risk of severe post-traumatic arthritis. Intraarticular fractures result in a pro-inflammatory hemarthrosis that may further exacerbate the chondral damage that was sustained due to the original injury. This project will study the effect of joint lavage on the concentration of inflammatory cytokines in the ankle following a high-energy tibial pilon fracture and the resultant effect on short-term patient outcomes.

High-energy pilon fractures are associated with an increased risk of post-traumatic arthritis and poor patient outcomes. The risk of arthritis is over 25% in many series and can be upwards of 50% in more highly comminuted fracture patterns. Intraarticular fractures result in an increase in the synovial concentrations of inflammatory cytokines and matrix metalloproteinases. Animal models have demonstrated the irreversible damage a persistent hemarthrosis may have on cartilage viability suggesting that prolonged exposure to blood in this highly pro-inflammatory milieu may further exacerbate the chondral damage from the initial injury. However, the impact of these local inflammatory processes on the risk of post-traumatic arthritis and patient outcomes remain unclear.

The long-term goal of our research is to develop treatment modalities including surgical and pharmaceutical interventions to reduce the risk post-traumatic arthritis and dysfunction following intraarticular fractures. The objective of this study is to determine the effect of ankle joint lavage on the risk of post-traumatic arthritis and patient outcomes following high-energy pilon fractures. First, we will obtain synovial fluid samples from the ankle joint of patients undergoing temporary external fixation of a pilon fracture for cytokine analysis. Then, we will randomize patients to undergo standard treatment with or without ankle joint lavage at the time of external fixation. Patients will undergo repeat synovial fluid analysis at the time of definitive fixation to determine the effect of lavage on the concentration of pro-inflammatory cytokines. Last, patients will be followed for a period of six months after surgery to determine the impact on functional outcomes.

The information generated in this study will substantially add to our understanding of the pathogenesis of post-traumatic arthritis in high-energy pilon fractures.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 18 years or older
* Present with an axially unstable tibial pilon fracture requiring temporary external fixation followed by delayed definitive internal fixation
* Able to give informed consent

Exclusion Criteria:

* Open fractures
* Delayed presentation greater than 72 hours post-injury
* Associated talar body fracture
* Presentation after initial ex-fix placement
* Unreconstructable or unsalvageable joint
* Preexisting ankle arthritis
* Previous ankle surgery
* Contralateral ankle injury
* Age less than 18 years
* Pregnant women
* Individuals who are incarcerated
TEAM-Project: Trial on the Effect of Anesthetics on Morbidity and Mortality

Volatile anesthetics may provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. In patients undergoing coronary artery bypass surgery, this preconditioning effect resulted in better cardiac performance, faster recovery and lower morbidity and mortality.

The investigators will perform a prospective randomized multi-center study to compare volatile with total intravenous anesthesia in patients at a high cardiac risk who undergo major non-cardiac surgery.

Basic research and animal studies have detected that volatile anesthetics provide some protection from myocardial ischemia, an effect called anesthetic preconditioning. Recent clinical studies have found that this preconditioning effect is of clinical relevance in patients undergoing coronary artery bypass surgery, resulting in better cardiac function and faster recovery after surgery, and in lower one-year morbidity. In patients undergoing non cardiac surgery, cardiac complications also are the major cause of perioperative morbidity and mortality. Myocardial ischemia frequently occurs during and immediately after non cardiac surgery in patients with coronary artery disease, and is a strong predictor of subsequent cardiac complications and death. Whether or not volatile anesthetics also provide clinically relevant protection from perioperative ischemia and subsequent cardiac complications in patients undergoing non cardiac surgery is unknown. Therefore, we will perform a prospective, randomized multi-center study to compare volatile with total intravenous anesthesia in patients at high cardiac risk who undergo major non cardiac surgery. We hypothesize that the use of a volatile anesthetic will reduce the incidence of perioperative ischaemia and myocardial injury, as indicated primarily by less ST-segment changes in the Holter ECG and, if there will be an effect, secondarily by lower incidences of elevated troponin T and NT-pro-BNP levels. And we hypothesize that the use of a volatile anesthetic will reduce the one-year incidence of cardiac complications and all cause mortality after surgery. The results of this study may apply to a huge percentage of surgical patients because coronary artery disease is the clinically most relevant co-morbidity, and its prevalence is expected to increase with the steadily increasing number of surgical patients aged 65 yr and older.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for a non-cardiac surgical procedure of high or intermediate cardiac risk are eligible if they have documented coronary artery disease (CAD) or are at high risk of CAD.

Exclusion Criteria:

* Ongoing medication with sulfonylurea derivatives (unless stopped ≥ 2 days before surgery) or theophylline
* Emergency surgery
* Unstable angina pectoris
* Preoperative hemodynamic instability
* Severe hepatic disease
* Renal insufficiency (creatinine clearance \< 30 ml/min)
* Severe chronic obstructive pulmonary disease (forced expiratory volume in 1 second \[FEV1\] \< 1 litre)
* Absence of written patient consent
Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships

Children will be randomly assigned to a Parent-assisted social skills training or Wait list. Baseline and post intervention rating will be obtained from teachers.

Targeted Area of Intervention: Social skills and development of best friend relationships. The specific intervention will be twelve small group sessions (90 minutes each) over a 6-week period. Child sessions consist of 4 components: 1) children report on homework assignments; 2) didactic presentation, behavioral rehearsal, and coaching, 3) coached play, and 4) new homework activities assigned with parent. Topics to be addressed across sessions include: reduction of maladaptive behaviors, information exchange techniques, places and times to make friends, group acceptance, praising other children, negotiation, play dates, dealing with teasing, and winner/loser skills. At the start of the intervention, parent and children will work with staff to develop a list of social skills, behaviors, and goals that they would like targeted for each child.

Parent component: Kathleen Mitchell (NOFAS) is an investigator to provide parent input to the study. Parent-only sessions will instruct them on key features being taught to their child. Concurrent parent sessions will include: 1) education on FAS/ARND, 2) parents present specific issues with their child, 3) review of current child session objectives and techniques, 4) new homework activities developed, 5) parent and child together review homework.

Evaluation Plan: Treatment and control (WL) groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 4-month follow-up. Baseline parent measures include Social Skills Rating Scale, FAS Behavior Scale, and Test of Advocacy Knowledge. Baseline child measures include knowledge of social skills. Process (e.g., homework completion, attendance, etc) and outcome (e.g., social skills ratings, progress towards individual goals) measures will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* children ages 6 to 8 years
* history of prenatal alcohol exposure

Exclusion Criteria:

* non english speaking
STI571 ProspectIve RandomIzed Trial: SPIRIT

To test whether increasing the dose of imatinib or combining it with IFNalpha or ara-C increases the rate of molecular response (as measured by the decrease in BCR-ABL transcripts after 12 months of treatment) in patients with previously untreated CML in chronic phase.

To compare overall survival in a selected arm according to molecular response at 1 year from randomization with the reference arm.

Imatinib at 400 mg daily has emerged as the preferred therapy for newly diagnosed CML patients who do not undergo allogeneic stem cell transplant.

A phase III randomized study, comparing imatinib at 400 mg per day to interferon plus cytarabine in newly diagnosed chronic phase CML patients enrolled 1106 patients from June 2000 to January 2001. 553 patients were randomized to each treatment. For comparative purposes, at 6 months, 75% of patients randomized to imatinib obtained a major cytogenetic response with 51% complete responses. Despite these impressive results, only a minority of patients treated with imatinib in this study achieved a molecular remission. When analyzed by log reduction in Bcr-Abl transcript levels using quantitative RT-PCR, 39% of patients achieved a 3-log reduction in Bcr-Abl levels, but only 13% and 3% achieved a 4- and 5-log reduction, respectively.2 To improve upon these results, various groups have tried higher doses of imatinib, and combinations of imatinib with interferon alpha or cytarabine. Each of these studies has used cytogenetic responses as the major endpoint.

Each of these therapies has increased toxicity as compared to 400 mg of imatinib alone and the rates of molecular remissions have not been reported.

Thus the purpose of this study is to first determine whether higher doses of imatinib or combining Imatinib with interferon or Ara-C would result in higher rates of molecular responses and if so, in better survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Patients with Bcr-Abl positive CML in chronic phase.
* Patients within 14 weeks of diagnosis and previously untreated for CML except for hydroxyurea and/or anagrelide.
* No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
* ECOG performance score of 0-2
* acceptable hepatic, renal, and cardiac function
* Informed consent signed up

Exclusion Criteria:

* Depressive syndrome not controlled
* Uncontrolled medical illnesses.
* Women with childbearing potential and male patients who are unwilling or unable to use an adequate method to avoid pregancy for the entire period of the study
Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi

Sulfadoxine-pyrimethamine (SP) is the current first-line treatment for uncomplicated malaria in Malawi. The malaria parasite P. falciparum has developed resistance to this drug so that the drug is much less effective than in previous years. This study was developed and conducted in collaboration with the National Malaria Control Programme of Malawi to assess the efficacy of four antimalarial drug combinations to provide evidence to assist the Malawian Ministry of Health in identifying and implementing as policy the next first-line antimalarial for uncomplicated malaria in Malawi. In an open, randomized trial in children under five years of age, four drug combinations, all of which are licensed in Malawi, are being assessed: amodiaquine plus sulfadoxine-pyrimethamine (AQ-SP), amodiaquine plus artesunate (AQ-Art), chlorproguanil-dapsone plus artesunate (CD-Art) and lumefantrine-artemether (LA). SP is also included as a fifth arm of the study for current data on its efficacy. Data on side effects of the drugs will also be collected. The results of this study will provide some of the information necessary to guide the Malawi National Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated malaria. The study adheres to the World Health Organization's 2003 standardized protocol for assessing antimalarial drug efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Children age 6 - 59 months
* Axillary temperature ≥ 37.5 °C
* Monoinfection with P. falciparum
* Parasitaemia between 2000 - 200000 parasites/µl
* Haemoglobin concentration (finger-prick blood sample by HemoCue) \> 7g/dl
* Consent by the patient's adult guardian
* Residence in the locality and willingness to attend for scheduled visits

Exclusion Criteria:

* altered consciousness
* convulsions
* prostration (inability to sit/stand/suck/drink)
* respiratory distress or breathlessness
* jaundice
* abnormal breathing
* haemoglobinuria
* circulatory collapse
* persistent vomiting (cannot keep down liquids)
* evidence of a diagnosis other than malaria on physical examination
* presence of mixed infection
* presence of severe malnutrition (as evidenced by symmetrical oedema involving at least the feet, light hair color, or cachexia)
* contraindications to the antimalarial drugs used, especially history of allergy
* history of receiving a drug with antimalarial activity in the week prior to enrollment
Adapted Physical Activity in a Chemotherapy Ambulatory Care Unit: Feasibility and Impact on Fatigue, Anxiety and Depression in Cancer Patients

Physical activity has demonstrated efficacy in cancer prevention and improves quality of life and outcome in cancer survivors. Patients undergoing chemotherapy, especially those with advanced disease, may have symptoms leading to inactivity. Adapted physical activity (APA) among those patients could improve their tolerance to the treatment, and thereby their quality of life. APA could be beneficial to patients with curable disease as well as patients undergoing palliative chemotherapy. Some studies suggest that fighting against loss of muscle mass could lead to a survival benefit. However, APA is not established in daily practice and has not yet been evaluated in a chemotherapy ambulatory care unit.

Primary aim of the study is to assess feasibility of an APA program in a chemotherapy ambulatory care unit of digestive, lung, hematological and dermatological cancers Secondary aim is to measure the impact of an APA program on fatigue, anxiety, depression and handgrip strength in patients beginning chemotherapy or targeted therapy for a digestive, lung, hematological or dermatological cancer, of any stage.

Assess feasibility of an APA program in a chemotherapy ambulatory care unit of digestive, lung, hematological, and dermatological cancers Measure the impact of an APA program on fatigue, anxiety, depression, handgrip strength

Eligibility Criteria:
Inclusion Criteria:

* Patients beginning chemotherapy or targeted therapy at UMA-CH ambulatory care unit of Reims, CHU, for a digestive, lung, hematological or dermatological cancer, of any stage
* Patients who agree to participate to the study
* Major patient

Exclusion Criteria:

* Patient with previous chemotherapy or targeted therapy in the UMA-CH unit
* Patient under law protection
* Minor patient
* Patient with neurological defect preventing from any physical activity
Efficacy of a Combined Transcranial Direct Current Stimulation and Virtual Reality Intervention

Rehabilitation options for stroke survivors who present severe hemiparesis in chronic stages are limited and may end in compensation techniques that involve the use of the less affected arm to achieve some degree of functional independence. Transcranial direct current stimulation (tDCS) is a non-invasive technique that has been used after stroke to promote excitability of the surviving neural architecture in order to support functional recovery. Interestingly, cortical excitability has been reported to increase when tDCS is combined with virtual reality. This synergetic effect could explain the promising results achieved by preliminary experimental interventions that combined both approaches on upper limb rehabilitation after stroke. The objective of this study is to explore the use of these interventions in subjects with severe hemiparesis and to determine its efficacy in comparison to conventional physical therapy


Eligibility Criteria:
Inclusion Criteria:

* chronicity \> six months
* severe paresis of the upper limb defined by the Brunnstrom Approach as stages I or II and by the Upper Extremity subscale of the Fugl-Meyer Assessment as scores below 19
* ability to maintain a sitting position for at least 60 minutes
* fairly good cognitive condition defined by scores in the Mini-Mental State Examination above 23.

Exclusion Criteria:

* pacemakers
* brain implants or other metallic objects (valves, coils, etc.)
* impaired comprehension that hinder sufficient understanding of the instructions defined by Mississippi Aphasia Screening Test scores below 45
* severe visual impairments
* emotional or behavioral circumstances that impede adequate collaboration
Association of Donor Age With Recipient Outcomes in Kidney Transplant

This is a single center study that seeks to study the impact of donor age on recipient outcomes in older kidney transplant recipients.

Over the years use of older kidney allografts has increased in an attempt to bridge the gap between demand and supply of organs. Simultaneously there has been in increase in the number of elderly renal transplant recipients. Numerous factors, both graft and host related, can impact recipient outcomes. The aim of this study is to evaluate the impact of donor age on recipient outcomes, based on the hypothesis is that elderly recipients who receive an older allograft have poorer outcomes that those who receive a younger allograft.

Study subjects will be recruited from the cohort of patients who received a kidney transplant at Northwestern Memorial Hospital.

The transplant clinical database and electronic medical record (OTTR) used in the Comprehensive Transplant Center at Northwestern University will be scanned to screen for kidney transplant recipients who fit the inclusion and exclusion criteria. Potential subjects will then be consented to participate in the study (see attached consent form), and subject participation will be documented in OTTR.

The sample size for the study is 80 subjects, who will be divided into 2 groups based on recipient and donor age. All demographic and clinical data will be collected for the donor and recipients at time of transplant. Follow up clinical data, including but not limited to recipient survival and graft failure will be collected and analyzed for the recipients. Subject confidentiality will be strictly maintained. All subject data will be stored on a secure server and only shared between members of the research team. The investigators plan to publish the results in a peer reviewed journal.

Eligibility Criteria:
Inclusion Criteria:

* All adult kidney transplant recipients
* Recipient age \> 60 years at the time of transplant
* Transplant was done between January 1, 2013 and December 31, 2014

Exclusion Criteria:

* Recipients of more than one kidney transplant
* Recipients of multi-organ transplants
Switch to Bictegravir/Emtricitabine/Tenofovir Alafenamide After Renal Transplant

This is an open-label study, where participants will be switched from their current HIV medication to the study drug, Biktarvy. Open-label means both the investigator and the participant will know what drug will be given. Participants will be followed for 48 weeks in order to monitor the efficacy, safety and tolerability of Biktarvy. The investigator hypothesizes that Biktarvy will be an important addition to the management of HIV-positive post renal transplant patients, especially since it is a one pill daily dosing regimen, thereby decreasing the pill burden in this population.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old on day of signing informed consent
* Positive for human immunodeficiency virus (HIV)
* Received a previous renal transplant
* Must have controlled HIV infection for at least 3 months prior to enrollment

Exclusion Criteria:

* Received a kidney from a donor who was HIV positive (unless a false positive)
* Currently taking Biktarvy for treatment of HIV
* Has allergies to any of the HIV medications in Biktarvy (bictegravir, emtricitabine, or tenofovir alafenamide)
* Currently taking dofetilide or rifampin
* Is pregnant or breastfeeding
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask

The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure compared to a traditional nasal mask.


Eligibility Criteria:
Inclusion Criteria:

• Male or female ≥18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device

Exclusion Criteria:

* Any medical or behavioral conditions that would compromise subject safety
* Under the age of 18 years old