cyrilzakka/clinical-trials huggingface dataset:
Gait Modification and Knee Joint Load

This pilot study aims to assess the effect of a 6-week individualized gait retraining program on knee load and symptoms in persons with knee osteoarthritis (OA).

This study aims to pilot-test an individualized gait retraining intervention to reduce knee load, guided by real-time visual feedback of the external knee adduction moment (KAM), a commonly used determinant for medial tibiofemoral (TF) joint load, during walking. Our central hypothesis is that individuals with predominantly medial TF OA can adapt their gait patterns to lower KAM during walking; consequently, reduce knee load and pain.

Eligibility Criteria:
Inclusion Criteria:

* people with radiographic TF OA fulfilling American College of Rheumatology classification criteria
* reporting average knee pain on walking \> 3 on an 11-point scale (0-10) in at least one knee
* pain or tenderness predominantly located on the medial knee.

Exclusion Criteria:

* medial TF joint space width greater than lateral
* Kellgren/Lawrence (K/L) grade 4
* knee surgery or intra-articular corticosteroid injection in the past 6 months
* uncomfortable walking on treadmill for 20 minutes
* unable to walk without a walking aide
* inflammatory arthritis
* other musculoskeletal or neurological disorders that affect gait patterns
* currently receiving physical therapy
Adherence to Exercise and Dietary Intervention in Cancer Patients

Intervention programs in cancer patients have been proposed with the aim of improving outcome. Bearing in mind that compliance is a limiting factor to the benefit provided from exercise and diet, assessing adherence to these interventions is paramount before pursuing further studies. Therefore the purpose of this study was to study the adherence of gastrointestinal cancer patients to a Combined Exercise and Dietary Intervention (CEDI) during neo-adjuvant chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients with esophageal, gastric, pancreatic and rectal cancer
* Due to commence neo-adjuvant chemo/ radiotherapy (ChT)

Exclusion Criteria:

-
Comparative Study Between UBE and PETD for the Treatment of Lumbar Spinal Canal Stenosis

OBJECTIVE Both unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD) are minimally invasive and effective surgical procedures for lumbar spinal stenosis.The object of this retrospective study was to compare the clinical and radiological outcomes between UBE and PETD.

METHODS In the period from July 2020 to December 2020, using UBE or PETD to treat lumbar canal stenosis.Patients were classified into two groups based on the surgery they had undergone. Preoperative and postoperative MR image was used to evaluate the removal rate of lumbar disc herniated material by two surgical methods. The two surgical methods are also compared and evaluated in terms of operation time, incision size, hospitalization time, etc.

It was performed as a retrospective analysis of prospectively collected data on patients received spinal endoscopic decompression between July 2020 to December 2020 was conducted. All patients underwent lumbar MRI examination with the result of L5-S1 disc herniation，accompanied by claudication or lower extremity radiation pain and other nerve compression symptoms. The symptoms have not improved with conservative treatments including physical therapy, medication, and epidural injection procedures for a minimum of 12 weeks. Patients who hadprevious spine surgery, infection, trauma, tumors or spondylolisthesis were excluded. The surgery was performed by the same experienced spinal surgeon and the surgical patient were closely followed for 3 months after surgery.

The investigators performed two kinds of endoscopic lumbar discectomy：unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD).

Eligibility Criteria:
Inclusion Criteria:

- Single-segment lumbar disc herniation/lumbar spinal stenosis

Exclusion Criteria:

* Multi-segment lumbar disc herniation / lumbar spinal stenosis、Have received surgery、Hypertension、Diabetes

Inclusion Criteria:

Inclusion Criteria:

Single-segment lumbar disc herniation Symptoms of nerve compression

Exclusion Criteria:

foraminal and extraforaminal disc herniation multilevel disc herniation, spinal stenosis spondylolisthesis scoliosis prior lumbar surgery spinal infection spinal tumor a history of hip or knee arthritis
Risk of Shopping Behavior of Tapentadol Immediate-Release (IR) Compared to Oxycodone Immediate-Release (IR)

The purpose of this study is to compare the risk of shopping behavior of tapentadol immediate release with the risk of shopping behavior of oxycodone immediate release.

This is a retrospective (a study that looks backward in time, usually using medical records and interviews with patients) matched cohort (designated group followed or traced over a period of time) study using IMS LRx database. This database covers 65% of all retail prescriptions in the United States and includes mail service and specialty pharmacy provider prescriptions independent of the method of payment. The study will include Opioid naive patients exposed to tapentadol immediate release (IR) or oxycodone IR from July 2009 to December 2010. A naive patient is a patient who has not received an opioid of any type in the 3 months before the index date. The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009. Patients will be followed for 1 year from their index dates. Each tapentadol IR-exposed patient will be matched to up to 4 oxycodone IR-exposed patients. Matching will allow to control in the design for potential confounding variables such as time of the exposure, geographic area, specialty of the prescriber, and age. These are variables that have been related with the risk of shopping behavior or abuse.

Eligibility Criteria:
Inclusion Criteria:

* Opioid naive patients (a patient who has not received an opioid of any type in the 3 months before the index date) exposed to tapentadol IR or oxycodone IR from July 2009 to December 2010 \[The index date is the date of the first prescription for tapentadol IR or oxycodone IR after June 30, 2009\]

Exclusion Criteria:

* Patients with use of any opioid 3 months before the index date
* Patients who within 4 days on or after the index date fill a prescription for a different opioid
* Patients who within 4 days on or after the index date fill a prescription for the same opioid but written by a different prescriber
Bioavailability of Nutrients Contained in Softgel Capsules vs Tablets

This study is a comparison of the bioavailability of nutrients contained in softgel capsules vs tablets.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 35
2. Body Mass Index (BMI) 21-27 kg/m2
3. Must be able to give written informed consent
4. Subjects must be willing to comply with all study requirements.
5. Subjects must understand, sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

1. Subjects for whom both eyes do not meet all inclusion criteria and either eye meets exclusion criteria
2. Subjects who are pregnant, lactating or planning to be pregnant during the course of the study
3. Subjects with known sensitivity to planned study concomitant medications
4. Subjects participating in any other ophthalmic drug or device clinical trial within 30 days of this clinical investigation.
5. Use of ocular drugs, other than study medications, during the study and within 14 days prior to study entry or any other ocular medication
Small Aortic Annulus - a New Solution to the Old Problem

In this prospective single-center study included 60 patients with a severe degenerative aortic stenosis and small aortic annulus (\<21 mm) who underwent standard AVR with stented bioprosthesis (group 1, n=30) and aortic valve reconstruction using autologus pericardium (Ozaki procedure) (group 2, n=30)

Aortic valve replacement (AVR) in patients with a small aortic annulus is a challenging problem. Implantation of a small aortic valve sometimes leads to high residual gradients, despite a normally functioning prosthesis. Patients with a small aortic annulus, especially those with a large body surface area, are at higher risk of prosthesis-patient mismatch, which is associated with worse clinical outcomes and decreased survival. The purpose of this study was to compare the hemodynamic performance among the 2 management strategies (standard AVR with stented bioprosthesis and Ozaki procedure) in the context of a small aortic annulus (\<21 mm)

Eligibility Criteria:
Inclusion Criteria:

* severe degenerative aortic valve stenosis

Exclusion Criteria:

* redo operation, infective endocarditis
A Study to Assess the Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants

The purpose of this study is to evaluate the drug levels of CC-92480 after coadministration with rifampin and itraconazole and the drug levels of digoxin and rosuvastatin after coadministration with CC-92480 in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Must have a body mass index between 18 and 33 kg/m2 (inclusive)
* Adult female of nonchildbearing potential or male, any race or ethnicity, and in good health as determined by the medical history, physical exam, vital signs, 12-lead electrocardiogram, and clinical laboratory assessments

Exclusion Criteria:

* Any surgical or medical condition possibly affecting drug absorption, distribution, metabolism, and excretion
* Any major surgery within 4 weeks of the first dose administration
* History of drug abuse within 2 years of the first dose administration

Other protocol-defined inclusion/exclusion criteria apply
The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis

To investigate the usage of budesonide as an agent in the injection of Type 2 chronic rhinosinusitis with nasal polyps

this is a randomized controlled clinical trial where 3 groups with nasal polyps will be treated medically, Group A with oral corticosteroids, Group B with budesonide intrapolyp injection, Group C with placebo saline intrapolyp injection

Eligibility Criteria:
Inclusion Criteria:

* All patients with type 2 CRSwNP -
* elevated serum IgE \& high absolute eosinophilia
* with any grade of nasal polyps
* ages between 18 and 60 years old
* patients who didn't have any contraindications of systemic steroids

Exclusion Criteria:

* All patients with previous nasal surgeries
* All patients with cystic fibrosis, ciliary dyskinesia, antrochoanal polyp, fungal sinusitis, unilateral nasal polyps, nasal tumors,
* patients who took systemic steroids in the last 6 months before our study
* patients with any previous nasal surgery
Aortic Root Enlargement in Aortic Valve Replacement

Aortic valve disease is a progressive illness that varies from minor valve thickening lacking obstruction of blood stream to severe calcification and alteration of the valve leading to weakened leaflet motion. Aortic valve replacement is a usual operation but can be complicated by a small aortic annulus requiring the insertion of an aortic valve prosthesis. Prosthesis-patient discrepancy results in worse outcomes.

Prosthesis-patient discrepancy results in worse outcomes, including elevated left ventricular work, decreased left ventricular mass regression, and has also been linked with high mortality. Therefore, Aortic root posterior enlargement by autologous fixed pericardium to insert an Aortic valve prosthesis with size suitable to patient body surface area to avoid the previous worse outcome of patient prosthesis mismatch. In this study the investigators will try to identify the benefits of Aortic Root Enlargement in management of Small Aortic Annulus in Patients with severe valvular aortic stenosis

Eligibility Criteria:
Inclusion Criteria:

* 17-75 years old
* patients with sever aortic valve stenosis undergoing valve replacement surgery
* informed consent has been obtained

Exclusion Criteria:

* Planned off-pump cardiac surgery
* Patients required intra-aortic balloon pump
* under 17 years of age
Cefoperazone/Sulbactam In The Treatment Of Serious Intra-Abdominal And Hepatobiliary Infections.

The primary objective is to collect data on treatment outcomes (clinical and microbiological cure), safety and tolerability of treatment with cefoperazone/sulbactam in patients with serious intra-abdominal and hepatobiliary infections in Slovakia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient of age 18 years or older.
* Patient with intraabdominal/hepatobiliary infection.?

Exclusion Criteria:

* Patients with known hypersensitivity to penicillins, cephalosporins, cefoperazone or to sulbactam.
The Use of a Virtual Reality Intervention on Stigma, Empathy and Attitudes Towards People With Psychotic Disorders

The goal of this clinical trial is to evaluate the effectiveness of a VR intervention on (1) stigma, (2) empathy and (3) attitudes towards those experiencing mental disorders.

Participants will review a VR intervention, and complete questionnaires at pre-test, post-test and one month follow-up.

Researchers will compare the VR intervention with a control VR intervention to evaluate the varying effects on stigma, empathy and attitudes towards those experiencing mental disorders.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are aged at least 21 years old
* Employed by the Institute of Mental Health as a physician, allied health professional or nurse.
* understands English
* work directly with patients.

Exclusion Criteria:

* unable to use virtual reality interventions due to reasons including motion sickness, disorientation, nausea and vomiting.
* history of epilepsy
Yoga for Pain and Opioid Dependence

This study is designed to develop an effective adjunctive treatment using yoga for chronic pain and opioid dependence.

This study aims to develop an adjunctive novel treatment intervention using yoga in opioid agonist maintained patients to effectively treat the co-occurring disorders of non-malignant chronic pain and opioid dependence (POD).

Specific Aims:

1) To conduct a pre-pilot phase with 8 patients with POD receiving opioid agonist maintenance treatment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Prescription opioid addiction or heroin addiction
* Moderate to severe chronic pain,
* Understands English

Exclusion Criteria:

* Current suicide or homicide risk
* Life threatening or unstable medical condition
* Medical or psychiatric condition that is judged to be of clinical concern by the PI or admitting clinician
* Pregnancy
Voice Tessitura and Size of the Required Laryngeal Mask

The choice of the size of the laryngeal mask (i-gel) is based on the weight. Even following the weight recommendations, it is quite common to choose a mask that is too big or too small, which leads to ventilation leaks (too small), or insertion failures (too big) and leads to a change of mask for bigger or smaller.

The i-gel are laryngeal masks (2nd generation) which consist of gel and have been designed by molding on larynx corpses. The masks are not inflatable (so not adaptable).

I-gel masks are used in adult and pediatric patients for weights ranging from 2 Kg to over 90 Kg to provide ventilation during general anesthesia.

Patients with a deep voice probably need a larger laryngeal mask than their weight alone suggests.

The investigators propose to measure the lowest sound emitted by the patient because it would seem logical that the larger the larynx is, the more the voice is serious.

This hypothesis will be verified a posteriori by the size of the laryngeal mask used and adapted by comparing it to the range of the voice.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 10 years
* Planned surgical procedure with the use of a laryngeal mask

Exclusion Criteria:

• Refusal to participate in the study.
A Study Comparing The Efficacy & Safety Of Torcetrapib/Atorvastatin And Atorvastatin In Subjects With High Triglycerides

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with Fredrickson Type IV Hypertriglyceridemia.

For additional information please call: 1-800-718-1021

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Fredrickson Type IV Hypertriglyceridemia

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
* Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study
The Applications of Point-of-care Ultrasound in ED Unselected, Non-critical Patients

to investigate prevalence of agreement between sonographic and clinical diagnosis in adult patients seen in an emergency department.

Point-of-care ultrasound (POCUS) can improve patient management in the emergency department (ED). However, previous studies have focused only on selected groups of patients, such as trauma, shock, dyspnea, or critically ill patients, or patients with an already known diagnosis. Most patients seen in the ED do not match these criteria. This study aims to investigate prevalence of agreement between sonographic and clinical diagnosis in adult patients seen in an emergency department.

Eligibility Criteria:
Inclusion Criteria:

* adult patients in the emergency department receiving ultrasonographic examinations were enrolled.

Exclusion Criteria:

* adult patients in the emergency department not receiving ultrasonographic examinations.
Ultrasound to Enhance Paclitaxel Uptake in Critical Limb Ischemia: the PACUS Trial

The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered ultrasound energy to improve local Paclitaxel delivery effects in critical limb ischemia patients due to femoral-popliteal artery disease.

Study design The PACUS Trial was a single center, single blinded, randomized trial designed to evaluate the safety and efficacy of intravascular percutaneous catheter-delivered high intensity, low-frequency ultrasound utilizing CardioProlific Genesis™ System to improve local paclitaxel delivery effect in patients with CLI due to femoral-popliteal calcific lesions and occlusions. The protocol was approved by a Local Review Boards and the Institutional Ethics Committee. All patients provided written informed consent before enrollment. The trial was conducted in accordance with the declaration of Helsinki.

Randomization Randomization occurred after successful crossing and pre-dilatation of the target lesion with a standard percutaneous angioplasty balloon without sub-intimal approach and/or flow limiting dissections. Patients were enrolled when a successful angiographic control was performed after PTA pre-dilatation. Subjects were randomly assigned by a computer-generated random sequence (2 blocks in a 1:1 ratio). Randomization was done in advance for all patients and without any stratification. The patients and physicians involved in the follow-up control were blinded to the treatment assignments through the completion of all 6 month follow-up evaluation. Operators were not blinded due to differences in treatment protocol. Twenty eight (28) patients were treated with an intravascular percutaneous catheter-delivered high intensity, low-frequency ultrasound and local Paclitaxel delivery with temporarily blood flow occlusion created by distal occlusion balloon (Study Group), and twenty eight (28) patients were treated with drug eluting balloon with conventional method (Control Group).

Eligibility Criteria:
Inclusion Criteria:

* Rutherford category ≥4
* femoral-popliteal lesion ≥10cm
* successful intraluminal recanalization without need of a stent to obtain a satisfactory angiographic result
* at least one patent below the knee vessel
* patients older than 18 years

Exclusion Criteria:

* Rutherford category \< 4
* pregnancy
* known allergies to study medications and materials
* need of sub-intimal approach to perform the recanalization
* target vessel stent release
VA Conditioning Regimen Allo-HSCT for Elderly Higher-risk MDS

The goal of this phase 1/2 trial is to test the safety and efficacy of Venetoclax Plus Azacytidine Conditioning Regimen Allo-HSCT in treating patients with higher-risk MDS.

The investigators will evaluate 2 year overall survival(OS) after transplantation in patients with higher-risk MDS. Progression free survival (PFS), incidence of acute GVHD, non-relapse mortality (NRM), graft-versus-host disease (GVHD)-free relapse-free survival(GRFS), and incidence of chronic GVHD at 1 and 2 years after transplantation will be counted.

Eligibility Criteria:
Inclusion Criteria:

* The patient should, in the investigator's opinion, be able to meet all clinical trial requirements.
* The patient is willing and able to adhere to the study visit schedule and other protocol requirements.
* The patient should be diagnosed with higher risk MDS according to the standard criteria of the World Health Organization (WHO).

Exclusion Criteria:

* Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
* Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
Functional Outcomes From Diets in Multiple Sclerosis

The purpose of this study is to test the effects of two dietary interventions, glycemic load and calorie restriction, on physical function, cognition, pain, fatigue, mood, and anxiety in adults with multiple sclerosis (MS). The investigators will also explore the how the diet interventions impact inflammation, immunity, and metabolic biomarkers.

100 participants will be randomized 1:1 to follow either a low glycemic load (GL) or standard GL diet for 32 weeks. For the first 16 weeks, all participants will eat enough calories to maintain their baseline weight. During the second 16 weeks, all participants will reduce calorie intake by 500kcal/day, with a goal of losing 5-10% of initial body weight. Participants will complete data collection at baseline (prior to randomization), at 17 weeks (after the weight stable phase) and again after completing the calorie restriction phase.

All participants will receive meal plans and groceries for the duration of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with RRMS or SPMS
* BMI 25-50 kg/m2 (overweight/obese)
* EDSS ≤6.5 (able to walk 100m with or without assistance)
* If on disease-modifying treatment (DMT), stable for 6 months
* If not on DMT, no DMT in previous 6 months
* No expected change to DMT in next 34 weeks
* Responsible for food preparation or have input into food preparation

Exclusion Criteria:

* MS relapse in previous 30 days
* Unable to walk 25 feet with or without assistive device
* Pregnant or breastfeeding
* Current use of insulin or sulfonylurea agents
* Score indicating low cognitive functioning on the Telephone Interview for Cognitive Status (TICS-m) assessment
* Actively engaged in a weight loss program or unwilling to follow assigned dietary pattern
* Unable to receive, store, or prepare food according to diet plan
* Medical contraindication to either treatment or control diet (including severe allergies that cannot be accommodated within either group)