cyrilzakka/clinical-trials huggingface dataset:
RCT: Multi-modal Analgesia for Laparoscopic Cholecystectomy

Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis. Topical cystic plate and port-site incision 0.25% bupivacaine significantly reduces pain after laparoscopic cholecystectomy.

Background: Peri-portal nerve stimulation has recently been suggested as a mechanism for pain after laparoscopic cholecystectomy (LapChole). We therefore conducted a PRCT to evaluate whether somatovisceral pain blockade reduces pain after LapChole.

Hypothesis:Analgesic efficacy of multi-modal analgesia is superior to standard analgesia for patients undergoing elective LapChole for symptomatic cholelithiasis. Specifically, topical cystic plate and port-site infiltrationwith0.25% bupivacaine significantly reduces pain after LapChole.

Design: Single-blinded PRCT Setting: Academic medical centers Patients and Methods: Between February and May 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to institutional standard non-opioid/opioid analgesic combinations (n=32), and institutional standard analgesia plus topical 0.25%bupivacaine spray onto the cystic plate and local 0.25% bupivacaine port-site injection,post-LapChole (n=31). Primary endpoint was patient-reported pain 1, 4, 6, 12, and 24 hours, and 1 week post-LapCholeusing the Visual Acuity Score (VAS, 0-10).

Results: Study groups were comparable clinicopathologically. There were no study-procedure-associated adverse events. A statistically significant reduction in mean pain score was apparent in patients receiving multi-modal analgesia at all early (1-6 hours) post-operative time points and at one week following LapChole(p\<0.05).

Conclusion: This PRCT shows significantly improved pain reduction with somatovisceral pain blockade than institutional standard analgesic combinations following LapChole for symptomatic cholelithiasis. For centers not utilizing adjunctive local anesthetic for this operation, this multi-modal analgesic approach can improve patient comfort during recovery.This approach serves as the basis for a planned 4-arm PRCT designed to provide further insights into the role of local anesthetics in multi-modal operative site analgesia.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic cholelithiasis undergo elective laparoscopic cholecystectomy
* non - pregnant women
* 18 years or older

Exclusion Criteria:

* undergoing urgent cholecystectomy
* patients operated on for indications other than symptomatic cholelithiasisT
* those having conversion from laparoscopic to open cholecystectomy
* those that withdrew from the study for any reason before the end of the required 7-day follow up (including those that died during that period)
* those with incomplete data.
EAGLE European Post Market Study

Prospective, multi-center, non-randomized, historical controlled, post-market study of patients requiring surgical repair of a focal articular cartilage lesion or osteochondral defect in the knee.

BioMatrix CRD is a CE marked device that is intended to repair focal articular cartilage lesions or osteochondral defects in the knee. BioMatrix CRD™ is a sterile, biphasic, bioresorbable scaffold designed to aid in the repair of cartilage and subchondral bone. The device serves as a scaffold for cellular and extracellular matrix ingrowth supporting the regeneration of cartilage and subchondral bone.

The purpose of this post-market study is to confirm the safety and performance of the BioMatrix CRD for its intended use. Fifty (50) patients will be enrolled at up to 10 hospitals in Europe. Patients will be followed for 2 years post-operative to examine the rate of adverse events associated with the device, track improvement in knee pain and knee function over time, and assess the quality of repair tissue.

Eligibility Criteria:
Inclusion Criteria:

* Pre-procedure KOOS Pain subscale score less than or equal to 70.
* ICRS grade 3 or 4 focal articular cartilage lesion on the medial femoral condyle, lateral femoral condyle or trochlea, which measures less than or equal to15mm in diameter.
* Cartilage lesion is amenable to treatment with a single BioMatrix CRD or an osteochondral autograft.

Exclusion Criteria:

* Previous cartilage repair procedure (i.e., microfracture, OATS, ACI) at the intended implantation site.
* Clinically significant (\> 5 degrees) varus or valgus malalignment in either knee.
* Osteoarthritis in the injured knee.
* Inflammatory arthropathy
* Osteomyelitis or other active infection in either lower limb.
* Cortisone or hyaluronic acid knee injections in the past 3 months
* Body mass index greater than 35.
Allogenic Mesenchymal Stem Cells And Physical Therapy for MS Treatment

This study aims at expanding Umbilical Cord derived Mesenchymal Stem Cells (MSCs) to a clinical scale according to Good Laboratory Practice and study its efficacy when compared to a Supervised Physical Therapy Program alone.

Umbilical cord derived MSCs bank will be generated and all patients given the same cells from the same biological sample.

Thorough clinical, cognitive and motor analysis will be performed at baseline and compared to outcomes at 3 different time points of all enrolled patients.

The study will consist of three arms: 1- Stem cells treatment 2- Stem cells and supervised physical therapy 3- Supervised physical therapy

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of definite MS according to the revised McDonald Criteria.
* Expanded Disability Status Scale (EDSS) ≤ 7
* Failure of standard medical therapy
* Disease duration of at least three years prior to enrollment.

Exclusion Criteria:

* Pregnant and lactating women
* Previous treatment with immunosuppressive agents in the last 12 months prior to enrollment
* Recent MS relapse in the month prior to enrollment
* Treatment with oral or parenteral steroids for any cause in the month prior to enrollment
* Significant systemic medical disorders including cardiac, renal, hepatic, hematologic, immunologic or endocrine disorders
* Previous treatment with interferons or glatiramer acetate in the 3 months prior to enrollment
* Any contra-indication for magnetic resonance imaging (MRI) or gadolinium contrast.
* Positive serology for HIV, Hepatitis B or Hepatitis C
* Any history of malignancy or exposure to radiation at any time prior to enrollment
* Any contra-indication to lumbar puncture
* Severe cognitive impairment that would interfere with the patient's ability to understand and sign the informed consent.
STEPWISE Parkinson: A Smartphone Based Exercise Solution for Patients With Parkinson's Disease

The aim of this study is to investigate whether a smartphone app can increase physical activity in patients with Parkinson's Disease in daily life for a long period of time (12 months).

Rationale: Exercise affords health benefits for people with Parkinson's disease (PD), but implementing exercise in daily life remains challenging. Moreover, many training programs are not very scalable. The investigators take an important step forward by developing and studying an innovative and fully decentralized smartphone-based program to increase long-term physical activity in people with PD in daily life.

Objective: The aim of this study is to investigate whether a smartphone app can increase physical activity in PD patients for a long period of time (12 months). The secondary aim is to test the potential group effect on physical fitness, motor- and non-motor symptoms. Thirdly, we aim to investigate whether there is a dose-response relationship between amount of physical activity and physical fitness, motor- and non-motor functioning.

Study design: Double-blind randomized controlled trial.

Study population: A total of 452 Dutch patients with PD who have no other medical conditions that markedly hamper mobility other than PD, no cognitive impairments that make it difficult to use a game on the smartphone and possess a suitable smartphone, will be recruited.

Intervention: Participants will be randomized to a group that will be motivated to increase their physical activity level to a small, medium, large or very large degree with respect to their own baseline level.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic PD
* Hoehn and Yahr 1-3
* able to understand the Dutch language
* able to walk independently
* equal to or less than 120 minutes of sports/outdoor activities per day (question 5-28 LASA Physical Activity Questionnaire (LAPAQ))
* less than 7,000 steps/day during 1-month baseline (week -4 until 0)

Exclusion Criteria:

* weekly falls in the previous 3 months
* medical conditions that hamper mobility other than PD
* living in a nursing home
* cognitive impairments that hamper use of the motivational app (subjective evaluation by the assessor)
* not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 or higher or Android 4.1 or newer)
Surgicel® (Fibrillar) in Non-variceal UGI Bleeding

The aim of this study is to assess of effect of Surgicel® (Fibrillar) for preventing delayed bleeding after endoscopic hemostasis in non-variceal upper gastrointestinal bleeding


Eligibility Criteria:
Inclusion Criteria:

* Patients with non variceal upper gastrointestinal bleeding proven by esophagogastroduodenoscopy
* Patients with active bleeding (Forrest classification Ia or Ib or IIa)

Exclusion Criteria:

* Patients with upper gastrointestinal tract malignancy
* Patients with acute severe illness
* Coagulopathy: liver cirrhosis, thrombocytopenia
* Pregnant women
Study of Individualized Selection of Chemotherapy in Patients With Advanced Pancreatic Carcinoma According to Therapeutic Targets

The purpose of this study is to determine the proportion of patients alive after 12 months of the beginning of the trial in patients with advanced pancreatic carcinoma individually selected and grouped according to the expression in tumor tissue for therapeutic targets.

Phase II, open two branches, in which conventional treatment is administered to patients diagnosed with metastatic pancreatic carcinoma. Patients will be randomized (1:1) to a treatment arm or control arm of experimental treatment guided by the therapeutic targets. Patients in the control treatment arm will be treated with any of the schemes used in the study according to the discretion of the physician responsible. Patients will be analyzed as "intention to treat." In the experimental treatment arm (therapeutic targets) and within 15 days will determine the markers of therapeutic targets detailed in the protocol, either from pre-existing tumor sample or a fresh sample obtained by biopsy. Based on the results of this analysis, we prescribe a chemotherapy treatment determined for possible treatments currently used in pancreatic carcinoma, gemcitabine, gemcitabine and capecitabine, gemcitabine and erlotinib, FOLFIRINOX, FOLFOX, FOLFIRI.

Treatment duration is indefinite .

Eligibility Criteria:
Inclusion Criteria:

* Histological or cytological diagnosis of pancreatic carcinoma.
* Patients\> 18 years.
* Measurable or not measurable disease.
* Life expectancy\> 3 months at the discretion of the investigator.
* Good general condition determined by the ECOG scale (score 0-1)
* Candidate for first-line systemic chemotherapy according to standard practice.
* Availability of tumor tissue or opportunity for tumor biopsy for the - determination of biomarkers and their correlation with treatment.
* Adequate hematologic function: ANC\> 1.5 x 103 / L, absolute count of platelets\> 100 x 109 / L, normal values of INR and PTT.
* Adequate liver function: total serum bilirubin \<2 mg / dL, ALT and AST \<3 times the upper limit established by the laboratory (LSR) or \<5 LSR in patients with liver metastases.
* Adequate renal function: serum creatinine \<1.5 LSR.

Exclusion Criteria:

* Patients who have received prior chemotherapy for advanced pancreatic carcinoma. Will not result excluding patients who had previously received adjuvant treatment with gemcitabine or fluoropyrimidines. Also not will be excluded patients who had previously received preoperative neoadjuvant treatment for localized disease with chemotherapy and / or radiotherapy.
* Patients for whom is contraindicated the administration of either drug used in first-line treatment for pancreatic cancer: Gemcitabine, 5'Fluouracilo, Leucovorin, Capecitabine, Oxaliplatin, Irinotecan, Erlotinib.
* Pregnant or breastfeeding women
Diagnostic Accuracy of x Ray Kub in Diagnosing Renal Calculi Keeping CT Scan as Gold Standard

In clinical practice both Xray and CT Scan KUB are reliable,however, Ctscan is superior to X ray KUB in detecting renal and ureteric calculi,the reson being stone that are missed by xray KUB are usually small and sould pass spontenously while other are usually with improper bowel preparation


Eligibility Criteria:
Inclusion Criteria:

* Female who will be advised X ray KUB and CT scan KUB for suspected renal \& uretrric calculi(flank pain )for \<24 hours .
* Age 18-49 years (because this is common age group for renal \&ureteric calculi).

Exclusion criteria:

* Female patients with pregnancy.
* Morbidly obese patients (Men\>129 kg women\>113kg)
* Patients with history of any abdominal trauma
Central and Peripheral Venous Catheters Associated Blood Stream Infection in ICU in Assiut University

Catheter related infections (CRIs) were found to be associated with several risk factors, including patient related risk factors such as age, gender, clinical status and catheter related risk factors such as the vascular access location, dwelling time, catheter type and number of lumens. In addition to the inserted solution type and the experience of the professional who performs the procedure ,These factors constitute important strategic points for actions to compare the infectious complications of peripheral versus central venous catheters in critically ill patients.

Nosocomial (hospital-acquired) bloodstream infections (BSIs) are an important cause of morbidity and mortality, with an estimated 250,000 cases occurring each year in the United States.

BSIs may be either primary or secondary. Secondary infections are related to infections at other sites, such as the urinary tract, lung, postoperative wounds, and skin. Most nosocomial BSIs are primary, as illustrated by the United States Centers for Disease Control and Prevention's National Nosocomial Infection Surveillance system, in which 64 percent of the nosocomial BSIs reported were primary BSIs. While some primary BSIs have no identifiable source, most are associated with intravascular catheters, and central venous catheters (CVCs) in particular.

Critically ill patients require intravenous administration of fluids and drugs.This can be achieved via peripheral or central catheters. Each device is associated with both mechanical and infectious complications. Complications associated with central lines are judged to be more severe. Some patients actually require the insertion of a central line due to the venous toxicity of the drugs or to the necessity of making sure that the infusion is regularly administered (example: high dose catecholamine infusion). Some physicians believe that most Intensive Care Unit (ICU) patients should have a central venous line inserted, whereas others feel that some patients may receive active drugs via a peripheral line in selected instances.

Endpoints are the rate of mechanical complications (difficulty in inserting the line, need for repeat insertion attempts, occurrence of arterial puncture, occurrence of pneumothorax) and of infectious complications (local catheter infection or catheter-related bloodstream infection).

Eligibility Criteria:
Inclusion Criteria:

* All patient at ICU Diagnosed nosocomial infection

Exclusion Criteria:

* Patients exist already infected before admission at hospital.
A Study of Participants With Advanced Non-Small Cell Lung Cancer Treated With Nivolumab in France After at Least One Prior Chemotherapy-based Treatment by Lung Initiative on Sequence Therapy

The purpose of this trial is to describe the following, for each cohort, in real world conditions in France:

* The characteristics and treatment sequence of patients treated with nivolumab
* The effectiveness of nivolumab treatment
* The safety profile of nivolumab
* Treatment patterns (e.g. duration of treatment, subsequent treatments) of nivolumab
* The patient-reported outcomes (PRO) in patients treated with nivolumab, at baseline and during follow up using the EuroQoL-5D-3L


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Pathologically confirmed diagnosis of advanced NSCLC
* Whose physician has already decided to initiate a treatment with nivolumab for the treatment of advanced NSCLC according to the European label
* Previously treated with at least one prior chemotherapy- containing regimen

Exclusion Criteria:

* Participants taking part in an interventional study for lung cancer treatment for which nivolumab is one of the investigational drugs
* Participants with a diagnosis of another primary cancer within the past five years
* Participants receiving IO within 12 weeks prior to nivolumab first infusion in the context of the present study

Other protocol-defined inclusion/exclusion criteria apply
Trial of IV Injection of CV787 in Hormone Refractory Metastatic Prostate Cancer

This is a multi-center, open-label, dose finding study of CV787 adenovirus in patients with hormone refractory metastatic prostate cancer. Patients will receive treatment intravenously at one of up to nine dose levels, each containing three to six patients.


Eligibility Criteria:
Impact of Environmental Exposure at Home Address on One-year Post-myocardial Infarction Survival

Numerous studies have explored the effects of environmental exposure to noise, air pollution and proximity to "natural" areas on various conditions. However, very few studies have focused on the "post-diagnosis" follow-up of patients after hospitalization for an ischemic cardiovascular episode and, to our knowledge, none have examined patient evolution at one year after myocardial infarction. Thus, the real influence of factors and pollutants widely represented in the urban environment, in particular air pollution, noise pollution, and proximity and accessibility to natural areas ("green" or "blue" spaces), on the evolution of post-myocardial infarction at one year remains to be identified and quantified.

The objective of the ENVI-MI project is to evaluate the impact of environmental exposure in the place of residence (noise, air pollution, proximity to "natural" spaces) on the evolution of post-myocardial infarction at one year within the Dijon metropolitan area.


Eligibility Criteria:
Inclusion Criteria:

Patient :

* registered in the RICO database
* hospitalized for MI between January 1, 2002 and December 31, 2008,
* whom residence is located in one of the 15 communes of the Dijon urban unit (except for patients living in the area subject to the noise exposure plan of the military airport)

Exclusion Criteria: NA
Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD)

The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess response to tDCS.

In this feasibility study the researchers propose to conduct a 5-day tDCS treatment protocol in hospitalized adult patients with TRD, with each treatment session lasting for 30 minutes, delivered twice daily, for a total of 10 stimulations over 5 days. Before and after the 5-day tDCS treatment protocol, assessments will include Montgomery-Asberg Depression Rating Scale (MADRS) to measure depressive symptoms, Snaith-Hamilton Pleasure Scale (SHAPS) to measure anhedonia, Stroop Test to measure memory and executive function, Revised Hopkins Verbal Learning Test (HVLT-R) to test verbal learning and memory, and Digital Symbol Coding Test (DSCT) to measure working memory. Electroencephalography (EEG) for objective electrophysiologic data will also be collected before and after tDCS. A wireless EEG unit (CGX, Cognionic, Inc.) will be used to collect EEG and peak alpha frequency (PAF) as potential target engagement marker for tDCS. The PAF measures the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance. Other potential predictors of treatment response measures collected at baseline include Adverse Childhood Experiences (ACE), premorbid intelligence quotient (pIQ), Wide Range Achievement Reading Test (WRART), and Socioeconomic Status (SES).

Eligibility Criteria:
Inclusion Criteria

* 18 years and older
* Clinical diagnosis of treatment-resistant depression (defined as depression that does not remit following two or more treatment attempts of an adequate dose and duration of a minimum duration of 4 weeks)
* Hospitalized in psychiatric units
* Voluntary admission status
* Moderate or severe depression, defined by PHQ-9 ≥ 15
* Ability to provide informed consent
* Ability to adhere to protocol

Exclusion Criteria

* Bipolar disorder
* Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
* Any active neurological condition (including seizure disorder, traumatic brain injury, stroke)
* Contraindications to tDCS (including pacemaker, metallic implants in the head or neck \[except orthodontic hardware\], skin disease causing irritation)
* Current pregnancy or positive urine pregnancy test (clinical)
* Any neuromodulation therapy (including ECT, rTMS, DBS, VNS, TES) within the last 3 months
Blood Flow Restriction Training in ACL Surgery

This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects

This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects. Both groups of subjects will undergo unilateral ACL reconstruction at University of Arkansas for Medical Sciences (UAMS), followed by prescribed PT at the UAMS Orthopedic Clinic at Colonel Glenn.

Up to 25 subjects will be enrolled. Half are randomized to the BFR group with the other will perform PT without BFR.

Data collection will occur at four approximate occasions: pre-surgery, 8-weeks postop, 12-weeks postop, and 16-weeks postop.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women, ages 18-34 years.
2. Scheduled to undergo elective ACL surgery at UAMS.
3. Capable of providing informed consent.
4. Willing to exercise with BFR.
5. COVID-19 negative or asymptomatic.

Exclusion Criteria:

1. Any surgical indication other than ACL repair.
2. Body mass index \>40.
3. Pregnant female.
4. Neurological, musculoskeletal, or other disorder that would preclude them from completing the exercise training intervention and all performance tests.
5. Hypertension as evidenced by systolic BP \>150 at rest OR diastolic BP \>85 at rest.
6. Heart failure as evidenced by use of prescription diuretics.
7. History of atrial fibrillation.
8. Oxygen saturation \<95% on room air at rest.
9. Any other medical condition that would interfere with testing or increase one's risk of complications during exercise.
10. Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
11. Compromised vascular circulation in the legs (e.g. peripheral vascular disease).
12. History of deep vein thrombosis.
13. Varicose veins in the legs.
14. Known Sickle cell disease or trait.
15. Unwilling to avoid using protein or amino-acid supplements during participation.
16. Unwilling to avoid using BFR during prescribed post-operative physical therapy.