cyrilzakka/clinical-trials huggingface dataset:
Pilot Study to Identify the Influence of Genetic Profile Aberrations on Patients With Recurrent Hernias

The aim of this study is to compare collagen composition in the skin and fascia of patients with recurrent or incisional hernias versus normal controls. We will identify potential genes responsible for genetic alterations in collagen deposition by using gene chip analysis of the tissue obtained and comparing the hernia group versus controls. The ultimate goal of this study is to identify target genes which may help us eventually predict which patients are at risk for developing post-operative hernias.

This is a prospective, case control pilot study with the aim of identifying potential genetic influences on recurrent hernia formation. Patients with recurrent abdominal hernias will be compared with normal control subjects. The study endpoints will compare tissue collagen I/III ratios between the groups. It will also use gene chip technology to identify potential differences in gene expression between the two groups, followed by confirmation of the differential expression using RT-PCR.

Patients will be enrolled from the surgical clinic population. If they consent to the study, both the hernia group and the control group will have 0.5 x 0.5 x 0.1 cm3 pieces of skin and fascia collected at the time of their surgery. A small piece of tissue will be used for immunofluorescene to study collagen I/III ratios. RNA will be extracted from the rest of the tissue for the genetic studies.

Eligibility Criteria:
Inclusion Criteria:

* Hernia Group: Diagnosis of ventral or incisional hernia.
* Control Group: appendicitis, symptomatic cholelithiasis or cholecystitis, adrenal disease necessitating adrenalectomy.
* Scheduled for an appropriate laparoscopic repair of above diagnosis.
* Females only: Not pregnant.

Exclusion Criteria:

* Steroid use
* Severe COPD or pulmonary disorders
* History of a connective tissue disorder
* Presentation for surgery with a diagnosis other than those listed above in inclusion criteria
Quantitative Liver Function Tests Using Cholates

As the treatments for liver disease and the availability of liver transplantation have progressed, the number of patients with end stage liver disease continues to increase. This has increased the need to risk-stratify patients with cirrhosis to better direct their treatments and provide an accurate prognosis for their outcomes. The traditional assessment of the liver patient has been limited to imaging, static measures of "liver function tests" and liver biopsy. This protocol is designed to increase the spectrum of tests in the evaluation of the patient with end stage liver disease.

This study involves using the dual cholate test as our quantitative liver function test of choice. Clearance of the oral cholate provides an assessment of portal blood flow. Clearance of the intravenous (IV) cholate provides an assessment of the systemic blood flow. The ratio of these clearances indicates the fraction of cholate that is shunted to the systemic circulation, and is called the cholate shunt fraction.2

This study will measure cholate elimination rate constant (cholate Kelim), clearance of orally administered cholate, clearance of intravenously administered cholate and cholate shunt. This study will compare the presence and extent of the cholate clearances and shunt fraction with the presence and extent of hepatic fibrosis and portal hypertension (as measured by a hepatic venous pressure gradient \[HVPG\] procedure.)

The patients who will be enrolled in this study may or may not be those who are undergoing clinically indicated hepatic venous pressure gradient (HVPG) measurements at Baylor University Medical Center, with or without a liver biopsy. Patients having the HVPG measurements will be admitted to Baylor University Medical Center (BUMC) and prepared in the routine clinical fashion for their clinically-indicated HVPG measurement. The cholate test, including blood draws, will be performed after the HVPG procedure. The cholate test may also be performed in the Hepatology clinic

Eligibility Criteria:
Inclusion Criteria:

* End-stage liver disease patient or Living Liver Donor or Congenital Heart Disease patients
* Age: 18 yr to 80 yr
* Patients or Legal Authorized Representative (LAR) must provide written consent and be willing and able to adhere to study requirements
* Stage 3-4 fibrosis by METAVIR score or clinical evidence of advanced fibrosis (End-stage liver disease patients only)

Exclusion Criteria:

* Hepatic encephalopathy Grade 3 or 4
* Pregnancy or intent to become pregnant
* Subjects with inability to provide consent for one's self
* Subjects with a life expectancy \< 1 year
* Subjects who have participated in an investigational drug study within the past 30 days
Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy

This active surveillance aims to collect the safety data of 100 NSCLC patients treated with nintedanib per the approved Indian label within 2 years from the date of commercial availability of the drug in India (23rd January 2017). The objective is to look at the safety of nintedanib in the real world setting.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB or IV, or recurrent NSCLC and adenocarcinoma histology after first line chemotherapy who have initiated or will initiate nintedanib \& docetaxel according to the package insert after the commercial availability of drug in India (23rd January 2017).
* Patients in whom it is possible to obtain voluntary informed consent from either the patient or patient's legally authorised representative (applicable for Group B and C patients).
* Patients in whom data collection is possible from the medical records (applicable for Group A and B patients).
* Further inclusion criteria apply.

Exclusion Criteria:

* Patients who were previously treated with nintedanib.
* Patients who are positive for endothelial growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements
* Patients who are participating in a clinical trial.
* Further exclusion criteria apply.
Tailoring a Mindful Intervention to Enhance Opioid Treatment

The main aim of this study is to better understand whether yoga can be blended with mindfulness as an additional intervention for people receiving medication assisted treatment at a Hartford-based community agency. If this program is acceptable to participants, then additional studies can allow us to determine its impact on stress and cravings. This intervention, developed by the researchers, is called BEING.

This study is a micro-trial of our mindful yoga intervention, BEING, tailored to the MAT clients. This study adapts an existing manualized program of yoga and mindfulness intervention (BEING) for MAT participants. Particularly important is addressing potential challenges and concerns regarding acceptability and feasibility of implementation in vulnerable males with substance dependence. We are enlisting the support of a mindful yoga expert with experience in related populations (i.e., previously incarcerated male veterans with mental health issues) in the adaptation process. This study is designed primarily to test the feasibility of the implementation of the intervention. We cannot draw statistically valid conclusions about the impact the intervention on outcomes, given the overall study design. We plan to collect participant feedback on whether or not the intervention is acceptable. We also want to evaluate the availability, accessibility, acceptability and feasibility of collecting certain measures that would be collected in a subsequent adequately powered treatment study.

Eligibility Criteria:
Inclusion Criteria:

* Receiving Medication Assisted Treatment 18 years or older Released from incarceration within the past year Currently receiving services from the partnering community agency English speaking

Exclusion Criteria:

* Under 18 years old Non-English Speaking Current incarcerated Not receiving Medication Assisted Treatment Not receiving services from the partnering community agency
Comparison of Pre- vs Post-dilution Haemodiafiltration in Children

Cardiovascular morbidity and mortality are increased in children on conventional haemodialysis. Haemodiafiltration (HDF) is a newer type of dialysis which has two main types (post-dilution and predilution HDF). Post-dilution HDF is associated with better vascular health, blood pressure and growth in children. Furthermore, pre-dilution HDF is shown to remove a wider spectrum of uremic toxin compared to post-dilution HDF in adults. The investigators need more data to define the optimum dialysis modality for children.

Hypothesis: In children with end stage kidney disease pre-dilution HDF (pre-HDF) achieves improved clearances across a wide molecular weight range compared to post-dilution HDF (post-HDF).

Plan of Investigation: Prevalent patients on thrice weekly HD or HDF who have a single pool Kt/v\>1.2 will be randomized in to either study arm A (pre-HDF, post-HDF) or B (post-HDF, pre-HDF) after a conditioning period on post-HDF. Dialysis prescription will be kept constant during study periods including blood flow, dialysate flow, dialysate content, filter type and size. Pre-dialysis and post-dialysis bloods will be drawn at baseline and at the end of each treatment with either modality. Reduction ratios of small and middle molecular weight toxins and protein bound toxins as well as markers of inflammation and nutrition will be compared between two modalities. Assessment of blood pressure (ambulatory blood pressure monitoring) and patient wellbeing (questionnaire) will be performed at the end of each period.

Children will be recruited from paediatric dialysis units in London, Istanbul Heidelberg and Lyon with extension to other centres to be confirmed.

Outcomes: If the results of this study demonstrate better clearance with pre-dilution HDF compared to post-dilution HDF, this will inform a future long-term outcome study comparing different HDF modalities and will contribute to define optimum dialysis modality for children.

Eligibility Criteria:
Inclusion Criteria:

1. Patients treated in paediatric dialysis centres between 5-20 years of age
2. Receiving maintenance haemodialysis with HD or HDF for the preceding 3 months
3. In post-dilution HDF for at least 4 weeks before the start of the study
4. Patients with stable vascular access (central line or arteriovenous fistula) and no plan to change access modality for the duration of the study
5. Provision for ultrapure water for HDF (defined as containing \<0.1 colony forming unit /ml and \<0.03 endotoxin unit/ml) documented in the month prior to study start

Exclusion Criteria:

1. Incident dialysis patients (on HD or HDF for \< 3 months)
2. Patients with acute infections in the preceding 2 weeks
3. Patients with underlying chronic inflammatory disorders (Including vasculitis)
4. Single pool Kt/V less than 1.2 in the month prior to the study start.
5. Children who have haemoglobin concentrations lower than 10 g/dL
BRAINI-2 Elderly Mild TBI European Study

Mild traumatic brain injury (mTBI) is one of the most frequent emergencies in the elderly population. Despite most mTBI are managed with cranial computed tomography (CT), only 10% of CTs show lesions, determining CT overuse. The use of serum glial fibrillary acidic protein (GFAP) and Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) have shown potential for ruling out the need for cranial CT. However evidence on biomarker use in mild TBI were not based on studies that included aged participants and patients with comorbidities for which biomarker levels could vary. This is why there is a need for a prospective study that assesses the predictive performance of these two biomarkers in the elderly population, both in elderly patients suffering mild TBI and in a reference population, including patients and participants with and without comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* BRAINI2-ELDERLY DIAGNOSTIC \& PROGNOSTIC:

  * Patients ≥65 years of age
  * Mild TBI (GCS 13-15 on admission) with indication of brain CT scan in the 12 hours after injury ;
  * Blood sample obtained ≤12 h after injury and CT scan preferably ≤6h from blood sample.
* BRAINI2-ELDERLY REFERENCE:

  * Non TBI patients ≥65 years of age

Exclusion Criteria:

* BRAINI2-ELDERLY DIAGNOSTIC \& PROGNOSTIC:

  * Age below 65 years.
  * GCS 3-12 on admission
  * Time of injury unknown
  * Time to injury exceeding 12 hours
  * Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)
  * Penetrating head trauma
  * Patient with mechanical ventilation from the trauma scene or prehospital management.
  * Venipuncture not feasible
  * No realization of brain CT-scan
  * Subject under judiciary control
  * Subject in inclusion period of a drug interventional study
* BRAINI2-ELDERLY REFERENCE:

  * Subject in inclusion period of another drug interventional study
  * Patients harboring a brain tumor
  * Patients that have had a stroke or neurosurgical operation 1 month prior to the inclusion in the study.
Analgesic Effects of US Bilateral Rectus Sheath Block for Laparoscopic GY Surgery

Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative analgesic effect for abdominal surgery with midline incision. Laparoscopic gynecologic surgery is accompanied by significant postoperative pain and usually IV-PCA is used to manage the pain.The purpose of this study is to investigate the analgesic effect of ultrasound-guided RSB to multi-port laparoscopic gynecologic surgery which has incision site at umbilical area. Patients will randomly assigned to two groups, RSB group and Control group. Each patients will assessed for time to first rescue analgesia, verbal numerical rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by IV-PCA by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.

Patients of RSB group will be performed ultrasound-guided bilateral RSB after induction of general anesthesia. The procedure will be performed bilaterally and 15 ml on each side, total 30 ml of 0.25% ropivacaine will be injected. After the procedure, a surgery scheduled will be proceeded. Patient of Control group will be proceeded the surgery after induction of anesthesia. All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl with 150 mg of ketorolac for 48 hours postoperatively. If a patient complains pain more intense than VNRS 4 or demands an analgesic drug, a rescue analgesic would be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Multi-port laparoscopic gynecologic surgery
* American society of Anesthesiologists (ASA) physical status classification I-II
* Age: 21-60

Exclusion Criteria:

* Gynecologic cancer operation
* History of previous abdominal surgery
* Allergy to local anesthetics(ropivacaine)
* Opioid tolerance
* Coagulopathy
* Infection at the needle insertion site
* Difficulty to cooperating
The Predictive Effect of the Inflammatory Response on the Evacuation of Mechanical Ventilation and the Mechanism

Infection and trauma take a important role in the acute respiratory failure.There are different causes and degrees of inflammatory reaction in the critically ill patient. The inflammatory reaction should also affect patients on mechanical ventilation dependence with body physiological response and disease prognosis in patients. Therefore, the investigators hypothesize that inflammation may have an important role in the prediction of weaning from mechanical ventilation.

In the process of mechanical ventilation, the patients were divided into two groups according to the failure of spontaneous breathing test and spontaneous breathing test.In the index of predicting mechanical ventilation, the investigators will take the index of inflammatory response, the function index of diaphragm and the amount of exhaled CO2 into account to reduce the failure rate of mechanical ventilation.

Eligibility Criteria:
Inclusion Criteria:

* oral, nasal tracheal intubation and mechanical ventilation in patients with respiratory failure
* mechanical ventilation time over than 48 hours
* Glasgow score greater more than or equal to 13 points

Exclusion Criteria:

* Aged less than 14 years or more than 80 years old
* patients with neuromuscular disease
* pure heart failure pulmonary edema patients
* patients with tracheotomy
Dual Mobility Cup in Total Hip Arthroplasty Preventing Dislocation in Patients at Risk

Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.

Hypothesis: The dual mobility socket reduce the rate of dislocation in patient at high risk but increase the incidence of postoperative infection.

Retrospectively study reviewing 34 patients operated with dual mobility cups in total hip arthroplasty between January 2009 and June 2012 at Sundsvall Hospital.

Indications for surgery is recurrent dislocation or patients at risk for dislocation after total hip arthroplasty suffering osteoarthritis or femoral neck fracture.

Patients are followed recording complications, reoperations, functional outcome (Harris hip score and EQ5D) in june 2012.

Eligibility Criteria:
Inclusion Criteria:

* operated with an cemented dual mobility socket at Sundsvall hospital
Strategies to Enhance the Experience of Exercise

This study aims to test the effect of three cognitive strategies to affect individuals' subjective experience of cardiovascular exercise. Participants will be randomly assigned to one of three strategies to use while exercising, both during an in-person session and self-directed two week exercise period.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and 40.
2. Insufficiently physically active for the past 6-months (i.e., does not meet American College of Sports Medicine \[ACSM\] guideline for cardiorespiratory exercise). The ACSM guidelines state that all healthy adults should engage in a minimum of 150 minutes per week of moderate intensity cardiorespiratory exercise, or 75 minutes per week of vigorous intensity exercise, or an equivalent combination of the two). On the eligibility screen assessment, we will define moderate and vigorous intensity exercise. Then we will ask individuals to report how many minutes of moderate and vigorous intensity exercise they engage in per week. We will use the ACSM's rule of thumb that 1 minute of moderate intensity exercise is equivalent to 2 minutes of vigorous intensity exercise. This will help to ensure that prospective participants who exercise for less than 150 minutes per week are not actually meeting the ACSM guidelines for cardiorespiratory fitness by engaging in vigorous intensity exercise. Thus, if total minutes of moderate intensity exercise and total minutes of vigorous intensity exercise (multiplied by 2) per week is equal to or greater than 150, callers will not be eligible for study inclusion.
3. Physically capable of safely engaging in moderate-intensity physical activity (PA)
4. Able and willing to access the Internet daily for two weeks
5. Willing to accept random assignment.
6. Have a smartphone or other mobile device (e.g., iPod Touch) that can play media (important if participants are assigned to the distraction condition)
7. Willing to engage in an exercise intervention specifically involving walking, jogging, running, or hiking (not other types of exercise)

Exclusion Criteria:

1. Are diabetic or receiving treatment for a metabolic disorder
2. Are currently pregnant
3. Are currently on antipsychotic medications
4. Have a history of cardiac or respiratory disease
5. Are receiving treatment for a heart condition or high blood pressure
6. Experience chest pains during and/or not during physical activity
7. Have a muscle, bone, or joint problem or injury that limit movement, make exercise painful, or could be made worse by exercising
8. Have a close family history of an adverse cardiac event before the age of 50.
The Long-term Degradation Outcome of Bilok Screws Used for ACL Reconstruction

The purpose of the study is to evaluate the long term outcome of a poly L-lactic acid / β-tricalcium phosphate (BILOK) biodegradable interference fixation screw used for arthroscopic bone-patellar tendon-bone ACL reconstruction,to determine if these BILOK screws completely biodegrade as expected three years after implantation, and to determine whether there is bone ingrowth into the defect remaining after resorption of the BILOK screw.

BILOK screws have been used for ACL interference fixation in the US since the late 1990s. As yet, there are no long-term studies to demonstrate the eventual biologic outcome of these devices. Animal studies indicate that the material used in BILOK implants completely degrades after 3 years, but these reports do not indicate what takes their place. Reports of other screw materials indicate that pure PLLA screws remain intact and can be removed whole at revision surgery in the first few months to years after implantation. Recently a report of a biopsy at 2 years after surgery indicated that whole fragments of a PLLA screw were observed. Schwach and Vert suggested that a PDLLA screw (combination of dextro and levo stereoisomers) completely degrade and is replaced by bone 3 years after surgery in sheep but no information is available for the human. In addition to being limited and anecdotal, most studies evaluating the degradation of biodegradable screws used in humans are conducted using plain radiographs and MRI to evaluate the status of the biodegradable screws. A report by Bach et al evaluated the MRI appearance of a biodegradable interference screw composed of a different polymer (polyglycolic acid 67% and trimethylene carbonate 33%) in eight patients at 2 years. It showed the reabsorption of the screw but suggested that MRI is not the most effective method for determining the bone ingrowth status in the area of the resorbed screws. CT scanning is a better methodology than MRI for this application and was recently used to study the disappearance of a pure PLLA screw at least 7 years after implantation. The purpose of this study is to evaluate the long-term resorption status of a Bilok screw and determine, using CT scan, what material replaces the screw.

Eligibility Criteria:
Inclusion Criteria:

* Prior patellar tendon autograft ACL reconstruction that used poly L-lactic acid (BILOK) interference fixation screws.
* Minimum follow-up of 3 years after the index surgery.
* Subject must be able to understand the verbiage of the consent form.
* The subject must be willing to undergo a physical examination of the previously operated knee.
* The subject must be willing to undergo a radiographic examination of the previously operated knee.
* The subject must be willing to undergo a CT scan examination of the previously operated knee.
* The subject signs the IRB-approved informed consent form.
* The subject is willing and able to complete required follow-up.

Exclusion Criteria:

* Subsequent ACL surgery or bone procedures in the area of the ACL graft attachments.