cyrilzakka/clinical-trials huggingface dataset:
Does Injection Site Matter? A Randomized Controlled Trial to Evaluate Efficacy of Knee Intraarticular Injections on Improval of Patient Reported Outcomes.

Knee osteoarthritis is one of the most prevalent orthopedic conditions worldwide. With the aging population, a 40% patient increase is expected to present at clinics with complaints of primary osteoarthritis by 2025. Multiple studies have attempted to establish non-surgical criteria for knee arthritis and usage of resources to avoid major surgery. It has long been accepted as a treatment option for patients who have failed to respond to NSAIDs and other non-surgical therapies to receive intra-articular injections of steroid and anesthesia mixtures to hold off disease progression.

Various studies have compared different sites of injection and the accuracy rate of the injection being within the joint. Recent studies report a 66% accuracy on palpation-guided injection on the anterolateral knee, 93% accuracy on palpation-guided injection on the superolateral portal of the knee, and new studies show an improvement of up to 98% with use of ultrasound guiding software. However, in a health care system with limited resources, providing patients with US-guided injections represented an increased cost of $178.35 per patient as per 2010 Medicare reports.

Therefore, assuming these accuracy rates, we will compare the anterolateral and superolateral portals for knee injection and their clinical effect to monitor if in fact there is a difference in patient reported outcomes. As a secondary analysis, if no difference is found, a strong case for palpation-guided injections versus ultrasound-guided injections can be made.

In this study we will prospectively enroll 60 patients to be divided into two 30 patient groups with primary knee osteoarthritis. Patients that qualify as subjects will be treated with an intraarticular knee injection through an anterolateral portal or a suprapatellar portal as per group in which they are placed. Scores will be given for pain of the injection and of the baseline illness and compared on a subsequent visit to assess self-reported functional outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria include Early osteoarthritis as per Brandt grades, persistent joint pain warranting a clinic visit, no previous injections given, significant pain in visual analog scale, failure of exercise and oral analgesics.

Exclusion Criteria:

* Exclusion criteria include advanced knee osteoarthritis, patients with bloody effusions, the use of warfarin or antiplatelet therapy, presence of any infection, patients with arthritis other than primary osteoarthritis, patients younger than age 25 due to low likelihood of primary arthritis, pregnant females, diabetics with poor glucose control, and patients that have previously been injected in knee(s).
Metabolic Activation With Almased for Type 2 Diabetes Patients

Overweight patients with type 2 diabetes are often being treated with an intensified insulin therapy. However, in many cases, even a high insulin dosage (\> 100 U per day) does not achieve satisfying metabolic control. A new therapy option is necessary that makes it possible to lower the daily insulin requirement and to improve metabolic control. The aim of this study was to investigate whether a protein-rich meal replacement is suitable to lower the daily insulin requirement and to reduce HbA1c and body weight.

The pilot study included patients with type 2 diabetes (n=22), that injected \>100 U insulin daily. During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced. Clinical parameters were determined at the beginning of the study, after 4, 8 and 12 weeks as well as after 1.5 years of follow-up. Wilcoxon signed rank test was used for the intention-to-treat analysis and Mann-Whitney test for subgroup analyses.

Eligibility Criteria:
Inclusion Criteria:

* patients with type 2 diabetes
* BMI \> 27 kg/m2
* age 35-75 years
* insulin therapy \>100 U insulin per day

Exclusion Criteria:

* contraindication for a calorie reduced diet
Fibroscan Predicts Complications After Hepatectomy

Most of the postoperative complications that may occur after hepatectomy are related to the underlying liver background, and the common preoperative tests do not completely predict such complications. Transient elastography by Fibroscan is used to calculate the stiffness and the steatosis of the liver, and it may be also used to predict postoperative complications after hepatectomy

A prospective cohort study on consecutive patients scheduled for hepatectomy was planned. Fibroscan was performed during the preoperative workup. Accuracy of the liver stiffness and steatosis measured by Fibroscan in predicting the presence of cirrhosis, of steatosis, and the development of postoperative complications was assessed by ROC curve, and multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary and secondary tumors scheduled for hepatectomy at our Unit
* Written consent to get the Fibroscan during the preoperative workup

Exclusion Criteria:

* Refute to get the Fibroscan
* Loss of data
Robotic Versus Conventional Training on Hemiplegic Gait.

The incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. In the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. But so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions after stroke.


Eligibility Criteria:
Inclusion criteria:

* Subacute first-time stroke patients(hemorrhage and ischemic)
* Age 18-80 years.
* Impaired Functional Ambulation Category at initial score 0-2
* Cardiovascular stable
* Given signed inform consent

Exclusion Criteria:

* Unstable general medical condition
* Severe malposition or fixed contracture of joint with an extension deficit of more than 30 degree
* Any functional impairment prior to stroke
* Can not adequately cooperate in training

  * Severe communication problems
  * Severe cognitive - perceptual deficits
Peri-operative NIRS Monitoring In Infants

The purpose of this research study is to examine the effects of routine anesthesia on infant brain oxygen levels. The investigators do not know how anesthesia effects blood flow in the brain of infants during surgery. This study will help the investigators detect possible blood flow changes in the brain for infants undergoing anesthesia. A monitor and sensors (NIRS or near-infrared spectroscopy) which use light to measure oxygen levels in the blood will be used. Sensors will rest on the child's skin and record measurements before, during and after the surgery.

Pre-operatively medical history will be collected along with baseline physiological data (Blood pressure, heart rate, date of birth, date of surgery, weight, gestational age at birth, gender, medical conditions, and medications). Given the importance of reliable blood pressure measurement- during the study, strict guidelines regarding proper blood pressure cuff placement and choice of cuff size will be followed. An upper extremity and the cuff index lines will be used to make sure that the cuff is appropriately sized. NIRS sensors will be applied pre-operatively in the operating room prior to induction of anesthesia. All NIRS values will be collected as blind values so as to not influence anesthetic management or clinical decisions.

Intra-operatively the NIRS values will be blindly recorded, physiological data and details of the anesthesia (the conduct of all clinical monitoring, including blood pressure measurements and anesthesia will not be affected in any way by this study). No additional blood pressure or other measurements will be made.

One week later the hospital record (for those infants still hospitalized) will be reviewed for evidence of new changes in neurological status (specifically seizures or other generalized or focal neurological deficits noted by the clinical team in the record and physical exam). For infants discharged home prior to one week after surgery, a phone call will be made to inquire about the occurrence of any events that required medical attention or treatment.

Eligibility Criteria:
Inclusion Criteria:

* Less than 6 months
* Scheduled for intubation/anesthesia for clinical purposes for a surgical procedure in the Children's Hospital of Philadelphia (CHOP) Main operating room that is expected to last longer than 30 minutes

Exclusion Criteria:

* Children where application of the NIRS would be impractical: for example surgery on the head or neck.
* Children scheduled for cardiac surgery
* Children with known major cardiovascular shunting
* Children with known or suspected neurological abnormalities
COLchicine and Thiamine in Heart Failure Due to Ischemic Heart Disease

The goal of this 2x2 factorial clinical trial is to test the efficacy of i) colchicine, and ii) thiamine in heart failure (HF) secondary to ischemic heart disease. The main questions it aims to answer are:

* Does colchicine reduce the risk of cardiovascular (CV) death, a HF event, or an ischemic CV event
* Does thiamine reduce the risk of cardiovascular (CV) death, or a HF event

Participants will undergo the following procedures:

* Run-in: All participants will receive colchicine 0.5 mg daily to assess drug tolerance over a 3-4 week period.
* Randomization: If colchicine is tolerated during run-in, eligible participants will be randomized in a 2x2 factorial design to receive i) colchicine 0.5mg daily or placebo, and ii) thiamine 300mg daily or no thiamine.
* Follow-up: Clinical outcomes, side effects, adverse events, and drug adherence will be captured during follow-up


Eligibility Criteria:
Inclusion Criteria:

1. Age \>/= 45 years
2. Documented ischemic HF as the etiology of HF, which includes:

   1. a prior history of CAD (defined as a history of myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, or non-invasive or invasive cardiac testing consistent with a diagnosis of CAD), and
   2. determination of CAD to be the cause primary cause of HF based on local investigator assessment
3. New York Heart Association (NYHA) class II-IV symptoms
4. Documented LVEF \</= 45% within 1 year prior to enrollment
5. Optimization of HF treatment based on local practice.
6. Ambulatory HF patients or stable hospitalized patients with HF will both be eligible for enrollment in the trial. For hospitalized patients, enrollment will require i) evidence of clinical stability from HF defined as no use of an inotropic agent or intravenous diuretic agent in the prior 24, and ii) expected discharge from hospital in the next 72 hours.

Exclusion Criteria:

1. Female who is pregnant, breast-feeding, or of childbearing potential and not using an effective form of birth control\*
2. Regular or required use colchicine or thiamine for other clinical indications.\*\*
3. History of allergic reaction to colchicine or to thiamine; or current or planned use of cyclosporine, verapamil, diltiazem, azole antifungal, macrolide antibiotic (except azithromycin), or HIV protease inhibitor
4. Use of a ventricular assist device or prior heart transplant
5. Coronary revascularization (coronary artery bypass graft surgery or percutaneous coronary intervention) within the 4 weeks prior to enrollment, or planned within the next 4 weeks.
6. Severe valvular disease
7. Chronic and severe renal dysfunction defined as eGFR \< 15 mL/min/1.73m2 based on local laboratory measurement done within 6 months prior to run-in\*\*\*
8. History of liver cirrhosis
9. Active malignancy (excluding basal cell or treated squamous cell carcinoma of the skin) requiring treatment and with a life-expectancy of \< 2 years.
10. Concurrent use of other experimental pharmacologic agents -
Medical Expulsive Therapy Post-SWL For Renal Stones

To evaluate the efficacy and stone free rate of placebo versus tamsulosin as medical expulsive therapy post-SWL in patients with renal stone less than 20 mm


Eligibility Criteria:
Inclusion Criteria:

* Renal stone ≤ 20 mm.
* Lower calyceal stone ≤ 15 mm

Exclusion Criteria:

* Women with known or suspected pregnancy or breastfeeding.
* History of alpa-blockers (more than 7 days prior to study participation)
* History of ureteral stricture
* Multiple (that is more than 2) stones
* Stone in solitary kidney (either anatomically or functionally).
* Presence of urinary sepsis.
* Estimated glomerular filtration rate \< 30 ml/min
* Contraindication or allergy to tamsulosin
A Pilot Study of Activated T Cell Therapy for Refractory/Relapsed Neuroblastoma

Activated T cell were manufactured through in vitro T cell expansion of autologous T cell. We designed this study to determine the feasibility and safety of Activated T-lymphocyte cell therapy for refractory/relapsed neuroblastoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 21 years or younger
* Histologically confirmed neuroblastoma
* Progressive disease after standard treatment or relapsed patient
* ECOG scale (ECOG-PS) ≤2
* Expected survival at least 3 months

Exclusion Criteria:

* Patients with autoimmune disease
* Patients with immunodeficiency
* Other malignancy 5 year prior to this study
* Severe organ dysfunction
* Severe allergic disease
* Severe psychiatric disorder
* Pregnancy or lactating woman
Micronutrients and Child Health Study

The purpose of this study is to determine to what extent supplementation with zinc and other micronutrients are efficacious in preventing malaria in young Tanzanian children.

Zinc is essential for the functioning of the immune system. Supplementation trials in Asia, Latin America, the Pacific and developed countries have shown that increasing zinc intake has great potential to control common infections in children, but the response to supplementation may be different in Africa, where the primary environmental challenge to children's health is malaria. Simultaneous supplementation with other potentially limiting nutrients may be required to overcome a lack of response when zinc is given alone. The project aims at measuring effects of daily oral supplementation with zinc and other micronutrients, given either alone or in combination, on malaria incidence and nutritional status, and on indicators of immunity.

Eligibility Criteria:
Inclusion Criteria:

* Aged 6-60 months
* Permanently residing in the study area
* Being moderately or mildly stunted (height-for-age z-score \<-1.5 SD)
* Informed consent from parents or guardians obtained

Exclusion Criteria:

* Severe wasting (weight-for-height z-score \<-3 SD)
* Hemoglobin concentration \<70 g/L
* Axillary temperature ≥37.50 °C with malaria antigenemia
* Signs and symptoms at randomisation suggesting malaria, hepatitis, HIV/AIDS, tuberculosis, sickle cell disease or other severe condition
* Unable to produce a venous blood sample (\>1 mL)
Postoperative Adjuvant Sintilimab in Hepatocellular Carcinoma With Microvascular Invasion

To compare the impact on recurrence risk of adjuvant Sintilimab (a recombinant fully human anti-PD-1 monoclonal antibody) for patients with hepatocellular carcinoma and microvascular invasion (MVI) after hepatectomy.

This study is a prospective, multicenter, open-label, randomized controlled clinical trial, aiming to recruit 360 patients with MVI-positive HCC who have undergone surgical resection. The patients will be randomly divided into three groups: the first group will receive six months of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 9 cycles), the second group will receive one year of adjuvant therapy with Sintilimab (200 mg every three weeks for a total of 18 cycles), and the Active surveillance group will be closely followed postoperatively. A maximum of one postoperative adjuvant TACE is permitted.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a histopathological diagnosis of HCC
* Undergone a curative resection
* Pathologically confirmed HCC with microvascular invasion (MVI)
* Aged 18-75 years
* No previous systematic treatment and locoregional therapy for HCC prior to randomization
* Absence of major macrovascular invasion
* No extrahepatic spread
* Full recovery from Curative resection within 4 weeks prior to randomization
* Child-Pugh: Grade A or B(7)
* ECOG-PS score: 0 or 1
* Subjects with HCV- RNA (+) must receive antiviral therapy
* Adequate organ function

Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinom or recurrent HCC
* Any preoperative treatment for HCC including local and systemic therapy
* Have received more than 1 cycle of adjuvant TACE following surgical resection
* Any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency
* Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug
* Subjects with inadequately controlled hypertension or history of hypertensive crisis or hypertensive encephalopathy
* Cardiac clinical symptom or cardiovascular disease that is not well controlled
* Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
* Any persistent serious surgery-related complications; esophageal and/or gastric variceal bleeding within 6 months
* Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
* Inability or refusal to comply with the treatment and monitoring
Alternative Sedation During Bronchoscopy

This protocol hopes to determine whether the use of dexmedetomidine-ketamine can reduce the use of standard of care fentanyl-midazolam sedation during bronchoscopy. This may result in less respiratory depression while providing better compliance with the procedure.

All patients enrolled in the study will be undergoing bronchoscopy, which is typically performed with sedation. All procedural sedation carries some risk. Several features of the study may lower the risk of sedation relative to that of conventional sedation. An anesthesiologist will be present throughout the procedure. Continuous monitoring of respiration with RIP will be employed. Administration of sedation will be via a volumetric syringe pump. Benefits specific to dexmedetomidine-ketamine include the lack of respiratory depression and greater hemodynamic stability.

Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 18 scheduled for elective flexible bronchoscopy in the endoscopy suite or OR of HUP

Exclusion Criteria:

* History of inability to complete bronchoscopy attributable to inadequate sedation
* Requiring more than 2 LPM supplemental oxygen to maintain SaO2 \> 90%
* History of allergy to study medications
* Pregnancy
* A history of psychosis
* Any condition deemed likely by the pulmonologist or anesthesiologist to pose a significant risk due to elevation of blood pressure, including cerebral/aortic aneurysm, and or ischemic cardiovascular disease
* Bradydysrhythmia deemed significant by the anesthesiologist or pulmonologist
* A diagnosis of significant renal or hepatic impairment
Non-Myeloablative Allogeneic HSCT From HLA Matched Related or Unrelated Donors for the Treatment of Low Grade B Cell Malignancies

A non-myeloablative treatment strategy and uniform selection criteria will enable patients with a variety of low grade B-Cell malignancies to attain long term disease control without unacceptably high treatment related mortality.

Non myeloablative transplant aims to achieve the immunological advantage of graft versus tumor effect as conventional myeloablative therapy without causing high treatment related toxicities. Non myeloablative transplant has been gaining wider acceptance as a way to achieve longer disease free and over all survival in patients with low grade B-cell malignancies, which otherwise is an incurable disease. Recent studies of non-myeloablative HSCT have demonstrated the powerful effect of graft versus leukemia alone against myeloma and other malignant B-cell malignancies if the transplant is performed for low grade, low volume disease.

Eligibility Criteria:
Inclusion Criteria:

* Stage II or III non-progressive disease Multiple Myeloma.
* CLL/SLL, and low grade Hodgkin Lymphomas that are in a very good partial response or complete response with non-progressive disease.
* ≤ 70 years old.
* Eligible and willing HLA matched related donor.
* Bilirubin \<2xULN.
* ALT and AST \<3xULN.
* LVEF \> 40%.
* Creatinine Clearance \>40mL/min.
* Pulmonary function DLCO corrected to ≥ 70%.
* Minimum performance score of 70%.
* Platelet count \>130 x103 micro L.
* LDH ≤1.5xULN.
* No proceeding co-morbid condition that significantly increases the risk of severe regimen related toxicity.
* No uncontrolled infections.

Exclusion Criteria:

* Age \>70 years old.
* Performance status \<70%.
* Uncontrolled infections or is HIV positive
* Prior malignancies that are felt to have a \<80% probability of being cured.
* Pregnant, breastfeeding, or refuse to use contraceptive techniques during and for 12 months following transplant.
* Prior Allograft
* History of rapidly growing disease at diagnosis or at any progression or have MDS.
* No eligible and willing HLA matched donor.