cyrilzakka/clinical-trials huggingface dataset:
Analyzing the Impact of the Now iKnow Health Care Price Transparency Tool

This project aims to assess the impact of a web-based health care cost and quality tool that is being implemented by a health plan for its members. The study will focus on members working for medium to large employers that have more than 90% of employees enrolled in deductible and tiered network health plans. The study will use an interrupted time series (ITS) design that includes random allocation of half of these employers to a study arm that will receive enhanced promotion of the tool and a $500 lottery incentive for its use in order to increase take-up. With these two study groups (a "high-dose" group receiving enhanced promotion and a lottery, and a "low-dose" group receiving routine promotion of the tool), the study will be able to evaluate whether access to a price transparency tool leads to reduced costs and more value-driven member behavior, and whether extra promotion increases take-up.

Members in the high-dose group who use the tool will be eligible to enter a monthly lottery to win a $500 prize during the 12-month intervention period. In addition to the lottery, employers in the high-dose group will receive additional promotional strategies such as a mailing and messages through the plan's member web portal to promote the tool and the lottery, and e-mails and flyers for employers to promote the tool and lottery to employees.

The aims of this project are to: 1) examine take-up of the tool and factors that predict take-up; and 2) to examine the impact of the tool on total and out-of-pocket health care costs and utilization


Eligibility Criteria:
Inclusion Criteria:

Health plan members from employers with at least 40 subscribers, of which at least 90% are currently in deductible plans or tiered network plans, and of which at least 80% were in deductible or tiered network plans in the prior year

Exclusion Criteria:

Members in non-group accounts and members in Medicare plans; members in states outside Massachusetts, New Hampshire, or Maine
Pilot Study of of Renal Arterial Sympathetic Denervation by Cryotherapy

Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During surgery the renal arteries are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in ambulatory blood pressure levels.

Non-randomized study of 5 subjects that have been selected for prophylactic open surgery due to abdominal aortic aneurysm. During the surgery the renal arteries at both sides are identified and subjected to about 60 seconds each of freezing by application of liquid nitrogen in dedicated catheters around the circumference of each artery. Renal arterial blood flow is checked by Doppler after the freezing procedure, during the surgery. Another 5 patients that are not subjected to the freeze therapy serve as controls. Main outcome is change in 24h ambulatory blood pressure levels and of course safety parameters such as creatinine levels.

Eligibility Criteria:
Inclusion Criteria:

* planned prophylactic surgery for abdominal aortic aneurysm

Exclusion Criteria:

* hypotension,
* inability to understand study protocol
Open Label Extension for Patients Coming From the Dosing Flexibility Study in Patients With Rheumatoid Arthritis (RA)

The purpose of this study is to continue to assess the safety of certolizumab pegol in combination with methotrexate (MTX).

Patients having completed the week 34 assessment in the C87077 (NCT00580840) study or having met the pre-defined criteria for flare (defined as patients that have randomized at Week 18 and experienced at 2 consecutive visits between Week 18 and Week 34 inclusive an equal to Baseline (W0) or worst swollen and tender joints counts), will be given the option to enroll in C87084 and receive certolizumab pegol \[400 mg at Entry, Week 2, and Week 4 followed by 200 mg every two weeks (Q2W)\] in combination with MTX until the drug is commercially available for the indication of Rheumatoid Arthritis (RA) in the patient's country or region or until further notice from UCB.

All patients will continue their MTX treatment at the same stable dose as during the C87077 (NCT00580840) study, unless there is a need to reduce the dose for reasons for toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be able to understand the written Informed Consent Form (ICF)
* Patients must have achieved an ACR20 (American College of Rheumatology) response at Week 16 and completed the entire C87077 (NCT00580840) study or patients having been randomized at Week 18 and having met the pre-defined criteria for flare
* Patients must have complied with the protocol requirements during their participation in C87077 (NCT00580840)
* Female patients of childbearing potential must have a negative urine pregnancy test at Entry and must continue to have negative urine pregnancy tests throughout their study participation
* Patients must be willing to comply with protocol

Exclusion Criteria:

* Patients must not have a diagnosis of any other inflammatory Arthritis
* Patients must not have a secondary, non-inflammatory type of Arthritis that in the investigator's opinion is symptomatic enough to interfere with the evaluation of the study drug on the patient's primary diagnosis of Rheumatoid Arthritis (RA)
* Patients must not have a history of an infected joint prosthesis with that prosthesis still in situ
* Patients who do not meet the Medical History Exclusion criteria, as defined per protocol. Examples of exclusionary criteria (not all-inclusive): pregnancy, chronic infection, active Tuberculosis (TB), high risk of infection, Lymphproliferative Disorder, acute or chronic Viral Hepatitis B or C, known Human Immunodeficiency Virus (HIV), Malignancy or history of Malignancy, history of severe, progressive, and/or uncontrolled Renal, Hepatic, Hematological, Gastrointestinal, Endocrine, Pulmonary, Cardiac, Neurological or Cerebral Disease
A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products

Supplementation with omega-3 fatty acids has been extensively researched and is known to provide healthful benefits for patients with a diversity of conditions and diseases. Not all omega-3 supplements are created equally however; some sources of omega-3 fatty acids are superior to others due to a greater bioavailability of omega-3 fatty acids than others, differences in source material, and processing techniques.

The purpose of this study is to determine which marketed omega-3 product provided the greatest effect, as measured against its' label claim and recommended dosage.


Eligibility Criteria:
Inclusion Criteria:

* Participant is fluent in English
* Participant understands the study requirements and is willing to comply with the protocol
* Participant is willing to provide written informed consent
* Participant is 18 years of age or older

Exclusion Criteria:

* Unwilling or unable to provide written consent
* Participant has taken omega-3 supplements in the last 3 months
* Participants consumes fish on a regular basis (more than 1 serving per week)
* Females who are pregnant or breastfeeding
* Participant has an allergy to fish or seafood
* Participant has been diagnosed with any medical illness or conditions
* Participant has a history of drug dependence or substance abuse (excluding nicotine)
* Participant is taking cholesterol or triglyceride lowering medications or supplements (statins, niacin, carnitine, fibrates)
* Individual has difficulty giving multiple blood samples
Immunglobulin M Enriched Intra Venous Immunoglobulin (IVIG) Therapy in Adult Respiratory Distress Syndrom (ARDS) Patients

57 patients with Adult Respiratory Distress Syndrome (ARDS) requiring Extracorporeal membrane oxygenation (ECMO) therapy were analyzed retrospectively. 28 patients had received immunglobulin M-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy.

These patients were analyzed regarding length of stay in intensive care unit (LOS ICU), length of stay (LOS) in hospital and regarding mortality.

57 patients with ARDS requiring ECMO therapy were analyzed retrospectively. 28 patients had received IgM-enriched immunoglobulin therapy (IVIG); 29 patients did not receive IVIG therapy.

Patient characteristics, like Acute Physiology And Chronic Health Evaluation (APACHE) and Sepsis-related organ failure assessment (SAPS) Score, preexisting diseases, origin of infection, duration of ECMO therapy were analyzed in these patients.

These patients were further analyzed regarding LOS ICU, LOS in hospital and regarding mortality.

Eligibility Criteria:
Inclusion Criteria:

* All data available
* ARDS with ECMO therapy

Exclusion Criteria:

* Data missing
Hip Prosthesis Components Position

The purpose of the study is


Eligibility Criteria:
Inclusion Criteria:

* indication for hip replacement surgery

Exclusion Criteria:

* pregnancy
* abnormal anatomy (hip dysplasia, fracture)
* previous srgery
Reactive Neuromuscular Training Effects on Side Bridge Endurance Test

The purpose of this study is to determine the effects of reactive neuromuscular training on muscular endurance test.


Eligibility Criteria:
Inclusion Criteria:

Healthy participants with no history of balance problems, ages 20 - 40.

Exclusion Criteria:

1. Lower extremity injury, surgery, visual, or vestibular condition that would effect balance?
2. Unstable joints of the lower extremity infections, injuries or other malignancies affecting the lower extremity?
Chronic Kidney Disease Knowledge and Awareness Among American Indians

Few educational intervention clinical trials have been conducted among those at risk for or with early chronic kidney disease. To the investigators' knowledge none have used digital storytelling as a means to deliver the educational message and have been conducted among American Indians, a group with high prevalence of chronic kidney disease and end stage kidney disease.

The aims of the research project are to:

1. Quantify levels of chronic kidney disease knowledge and awareness among American Indians.
2. Determine the effectiveness of a culturally tailored health presentation with computerized digital stories made by American Indians for improving chronic kidney disease knowledge and factors thought to be preventative of chronic kidney disease or its progression at baseline and follow-up in a pilot educational clinical intervention trial.


Eligibility Criteria:
Inclusion Criteria:

* Strong Heart Study or Strong Heart Family Study participant

Exclusion Criteria:

* End Stage Renal Disease
The Effect of a Single Dose of Lamotrigine on Brain Function in Healthy Volunteers

This study will test whether a single dose of Lamotrigine (300mg) exerts significant effects on emotional processing, cognitive ability and neural activity in healthy volunteers compared to placebo.

Glutamate has been implicated in the aetiology of mood disorders and there is current interest in developing novel agents targeting this system. However, the role of glutamate in human emotional function is relatively unknown. Lamotrigine's pharmacological profile involves a blockade of voltage-gated sodium channels, leading to an inhibition in the release of glutamate and resulting in a general inhibitory effect on cortical neuronal function.

The current study plans to investigate the effects of modifying glutamate on emotional processing, cognitive function and neural activity. For this, 36 healthy volunteers will be recruited to the study and randomised to receive a single dose of lamotrigine (300 mg) or placebo. Two hours after drug administration, the effects of emotional processing via the use of cognitive tasks will be assessed using fMRI. This will be followed by an emotional test battery that will measure aspects of cognitive function as well.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Aged 18-40 years
* Willing and able to give informed consent for participation in the study
* Sufficiently fluent English to understand and complete the task

Exclusion Criteria:

* Current usage of psychoactive medication
* Current usage of the contraceptive pill
* Any past or current Axis 1 DSM-IV psychiatric disorder
* Significant medical condition
* Current pregnancy or breastfeeding
* Current or past history of drug or alcohol dependency
* Participation in a psychological or medical study involving the use of medication within the last 3 months
* Previous participation in a study using the same, or similar, emotional processing tasks
* Smoker \> 5 cigarettes per day
* Typically drinks \> 6 caffeinated drinks per day
* Takes folic acid supplements
* History of recurrent allergies and rashes
* Contraindication to MRI (e.g. claustrophobia and metallic implants)
OLGA Stage is More Appropriate in Predicting Early Gastric Cancer

The aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.

Japanese endoscopic gastric atrophy (EGA) classification, operative link on Gastritis Assessment (OLGA), operative link on intestinal metaplasia assessment (OLGIM) and gastritis pattern are used in evaluating the severity of gastritis and intestinal metaplasia in different countries, which are risk factors of gastric cancer. The aim of the present study was to evaluate characteristics of background mucosa in early gastric cancer (EGC), and to seek for the optimal assessment for EGC screening.

A prospective study was conducted encompassing EGC patients (cases) and non-EGC patients (controls). All patients were performed endoscopic examination and systematically biopsied. Outcome measures were assessed and compared, including EGA classification as well as the OLGA/OLGIM assessment. Helicobacter pylori(H. pylori) status was detected in the meantime. A stepwise logistic regression model was performed to analyze correlations between EGA, OLGA, OLGIM and EGC.

Eligibility Criteria:
Inclusion Criteria:

* The age of patients is from 40-80 years
* Must undergo esophagogastroduodenoscopy

Exclusion Criteria:

* Clinical diagnosis of advanced gastric cancer
* Post-subtotal gastrectomy
* Acute upper gastrointestinal bleeding
* Severe systemic diseases
* Lack histology
Comprehensive Protocol for Treatment of Upper Limb Spasticity in Post-stroke Hemiplegic Patients

The general objective of this study was to evaluate the efficacy of the comprehensive protocol in improving post-stroke upper limb spasticity. The specific objectives were to evaluate pain improvement and changes in quality of life and functional capacity in patients who were subjected to the comprehensive protocol compared with those in the patients who underwent sham interventions.

Background: Managing post-stroke upper limb spasticity is a major challenge in the rehabilitation field. The objective of this study was to evaluate the efficacy of a comprehensive treatment protocol with four therapeutic modalities in the recovery of patients with chronic stroke by evaluating clinical, neurological and functional outcomes.

Methodology: Thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. The treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. Spasticity, range of motion, pain, functionality and quality of life were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years;
* Diagnosis of ischemic or hemorrhagic stroke at least six months previously;
* Presence of single upper limb spasticity

Exclusion Criteria:

* Spasticity due to conditions other than stroke;
* Hypersensitivity to lidocaine;
* Use of cardiac pacemakers;
* Presence of coagulation disturbances;
* Insufficient perceptual and cognitive capacity to understand the proposed treatment and answer the questionnaires
Study of the Diagnostic Value of Stable Calcium Isotope Profiling in Bone and Calcium Disorders

The purpose of this study is to determine whether mass spectrometry analysis of stable (non-radioactive) calcium isotopes in plasma or urine samples can help in the diagnosis of bone and calcium disorders.

The aim of this pilot study is to explore the diagnostic value of MC-ICP-MS (multicollector inductively coupled plasma mass spectrometry) or TIMS (thermal ionization mass spectrometry) measurement of endogenous stable calcium isotopes in plasma and urine samples in patients seen during routine clinical care at the outpatient clinics (incl. Center for Metabolic Bone Diseases) of the University Hospitals Leuven.

Eligibility Criteria:
Inclusion Criteria:

* DXA (dual energy X-ray absorptiometry) T-score known clinically to be = or \< -2.5 OR presence of low-energy osteoporotic fractures (i.e. excluding those of the skull, fingers and toes) \[for osteoporosis and calcium malabsorption patients\]

Exclusion Criteria:

* inability to provide written informed consent
Iliac, Common and External (ICE) Artery Stent Trial

The objective of this prospective, randomized,controlled and multicenter trial is, to compare recurrent-restenosis rates in the balloon expandable VISIO-PRO stent arm and the selfexpandable PROTEGE GPS stent arm 12 month after treatment of stenosis or occlusions of common and external iliac artery disease.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 21 years.
2. Patient must sign informed consent form.
3. Patient must agree to participate in the study and comply with follow-up requirements.
4. Clinically, all patients must be in Rutherford category 1 to 4.

   Angiographic Inclusion Criteria:
5. Planned stenting (degree of stenosis 70-100%) within the common or external iliac artery. The target lesion must not extend beyond the iliac arteries.
6. Lesion segment starts at the aortic bifurcation and ends at the take off of the common femoral artery (Offset of the iliac circumflex artery beneath the ligamentum inguinale).
7. The length of the lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler).
8. The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound or (MR-) angiography.
9. Patency of ipsilateral profunda artery. Ipsi- or contralateral artery lesions of the leg can be treated prior to the treatment of the study lesion.
10. In cases of two or more stenotic regions within the segment, these are considered separate lesions if there is a nonstenotic or only mildly stenotic (\< 30%) segment of at least 2 cm in length between them. Otherwise, they are considered as single lesion. In case of separate lesions, only the proximal lesion will be taken as the target lesion!
11. A tandem lesion that can be treated with one stent will be considered as one lesion.

Exclusion Criteria:

1. Patient is currently participating in another clinical trial
2. Pregnancy or pregnancy planned during study duration
3. Life expectancy less than 2 years
4. Co-morbidities preventing study participation
5. Severe coagulation disorders
6. Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel.
7. Active gastric ulcer or gastrointestinal bleeding
8. Thrombotic occlusion of the target vessel within previous 4 weeks.
9. Treatment of target lesion with laser or atherectomy devices.
10. Dialysis dependency.
11. Manifest hyperthyreosis.
12. Known allergy against contrast agent that cannot be adequately controlled by usual premedication.
13. Known heparin intolerance.
14. Known paclitaxel intolerance.

    Angiographic:
15. Target lesion extends into the femoral artery.
16. Symptomatic untreated inflow lesion \> 70% in ipsilateral iliac arteries. Pretreatment of iliac stenosis is possible.
17. Target Lesion is in aortic bifurcation and needs treatment with "kissing balloon technique"
18. Lesion in abdominal aorta that needs treatment.
Effects of FMS Functional Movement Training on Body Posture Control in College Female Aerobics Athletes

For this experiment, it was planned to randomly assign 40 female college aerobics athletes to two groups: a traditional physical training group (control group, T, N=20) and a functional training group (experimental group, F, N=20). The control group will use traditional physical training methods, while the experimental group will use a training program based on the FMS functional movement design. The experimental group was scheduled to undergo a 12-week FMS functional movement training intervention, with each session lasting 40 minutes. Before and after the experiment, the subjects' FMS scores, body posture control, and competition performance will be measured.

Randomized into: Control, Traditional physical training Group, T, N = 20 , Intervention, Functional training Group, F, N = 20). The control group used traditional physical training methods, and the experimental group used FMS-based functional movement training methods. A 12-week functional movement training program was used and the experimental group was given intervention training 4 times a week for 40 min each time, and FMS scores, body posture control, and athletic performance were tested before and after the intervention. It was expected that the main assessment criteria would include the seven movements of the FMS Functional Movement Test (deep squat, hurdle step, lunge squat, shoulder flexibility, active straight leg raise, trunk stability push-up, and trunk rotational stability) as well as dynamic and static body postural control in aerobics movements. Tests of T-run and basic pace Y-jump time and athletic performance were used as secondary outcomes. The main tools included: a set of FMS tester, a roll of yellow tape, a measuring tape, a stopwatch, and a test chart for each index.

The test was divided into two phases. Phase 1: corrective training (1-4 weeks), Phase 2 is: the overall movement (functional patterning) 5-12 weeks, while the design concept of the program is shown in the increase of difficulty, specialization, but also includes the process of static stability to dynamic stability, and then finally, the overall movement pattern training. Tools used: balance disk, Swiss ball, solid ball, foam shaft, massage stick.

Eligibility Criteria:
Inclusion Criteria:

① Must be able to understand and comply with the study regulations and sign an informed consent form.

② Have a stable summer training schedule with no plans to return home during the summer.

③ No serious diseases or complications.

Exclusion Criteria:

Athletes with recent sports injuries who may not participate in the training program.
The Effects of Video-based Yoga Interventions for Patients With Post-corona Virus Disease

Aimed to understand if yoga exercises are superior to posture exercises as an alternative exercise therapy for relieving musculoskeletal pain, improving functional status, and improving quality of life during the post- corona virus disease (COVID-19) period?

Eighty five of 200 post- COVID-19 patients, who met the inclusion/exclusion criteria obtained from the records of the State Hospital. The participants were divided into video-based (VB) yoga (n=40), home-based (HB) posture exercise (n=28), and control (n=17) groups. The socio-demographic characteristics, pain status, walking and balance, and quality of life were evaluated twice, once before and eight weeks after the exercises.

Eligibility Criteria:
Inclusion Criteria:

* recently diagnosed with Covid-19 and discharged from the hospital;
* being at level 0: neglected functional limitation or level 1: negligible functional limitation on the Post-Covid-19 Functional Status Scale,
* referred for physical therapy for musculoskeletal pain.

Exclusion Criteria:

* having any type of surgery in the last six months,
* being pregnant,
* being level 2 or above on the Post-Covid-19 Functional Status Scale