cyrilzakka/clinical-trials huggingface dataset:
Study of Titanium-Coated PEEK Cages for Degenerative Disc Disease

Prospective Follow-up study of CeSPACE XP coated PEEK cages for the treatment of degenerative cervical disc disease

Anterior cervical discectomy and fusion (ACDF) has been accepted as the standard procedure for the treatment of myelopathy and radiculopathy in the cervical spine. A tricortical iliac crest bone graft is the traditional inter-body fusion material that can show perfect bony fusion and maintain the patency of the neuroforamen. However, donor site complications were reported in fusion with an iliac bone graft, such as subcutaneous hematomas, infections, and chronic wound pain.

Currently, the titanium cage and polyetheretherketone (PEEK) cage are the two most common cages in clinical practice. The ideal cage should lead to a high fusion rate and prevent complications, such as subsidence and loss of correction.

Even though a titanium cage can provide long-term stabilization, increase lordosis, and increase foramina height compared with the iliac bone graft, some inferior clinical outcomes appeared in clinical practice. Loss of correction is a major complication of subsidence that may eventually affect cervical spinal function after the operation.

A modulus of elasticity close to cortical bone might contribute to advantages in stress distribution and load sharing, which can contribute to a lower subsidence rate and, thus, better clinical results, making PEEK cages more welcomed by surgeons.

It is supposed, that in the cervical fusion procedure, a porous coating of a PEEK cage will lead to favourable results. Therefore, the present study intends to show these results, in a larger patient cohort who received such a coated cervical cage.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients who received a CeSPACE XP cage between August 2013 and January 2017

Exclusion Criteria:

* Pregnancy
* Patient consent not signed
Study of Improving Insulin Sensitivity by Electroacupuncture Therapy

The aim of this study is to find out whether the hypoglycemic and improving insulin resistance effect will appear or not, when EA applying on specific acupoints of NIDDM patients.

Some previous animal model studies reveal that electroacupuncture (EA) applying on specific acupoints, such as Zhongwan and Zusanli acupoint, can reduce plasma glucose levels and encourage insulin secretion, even improve insulin resistance. In this study, we want to observe these results on type II diabetic patients who have been diagnosed in five years under a study design of randomized control trial (RCT) to obtain evidence on clinical.

We undertook a randomized, single blind and sham group controlled study to evaluate the effect of EA with a frequency in 15 Hz and fixed intensity (10 mA) on human Zusanli acupoint. A total of 26 newly diagnostic type II diabetic patients are enrolled in this study. They are randomly divided into 2 groups. There are 13 patients in the experimental group (EG) with EA treatment, and the other 13 patients are divided into control group (CG) with sham treatment. The main outcome is the changes of laboratory parameters between before and 30 minutes after the test.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed NIDDM patient within 5 years
* age between 30 to 65 years old
* controlled BP below 140/90 mmHg
* oral hypoglycemic agent (OHA) therapy with Gliclazide twice per day.

Exclusion Criteria:

* disorders of hemostasis
* patient had received insulin therapy
* severe disease such as CVA, CAD within 6 months
* Arrhythmia history and on pacemaker.
Walking Away From Back Pain, One Step at a Time

This study will investigate if a 12-week, individually-tailored walking program, using pedometers will be a more clinically and cost-effective option for the management of chronic low back pain than standardized advice and education.

Specific objectives of the study are:

1. To determine perceived levels of disability and baseline levels of walking activity in a sample of those with chronic low back pain (CLBP)
2. To determine the uptake and adherence to a pedometer-driven walking program for people with CLBP
3. To test the clinical and cost-effectiveness of a walking programme to improve outcomes for CLBP compared to a standardized back care education package
4. To test the feasibility of a walking programme in a sub-sample of rural Saskatchewan farmers/agricultural workers.

Eligibility Criteria:
Inclusion Criteria:

* males and females aged 18 years or over,
* experiencing low back pain (i.e. between the 12th costal margin and gluteal fold with or without associated leg pain) persisting for a minimum of three months, and
* assessed as capable of participating in a walking programme.

Exclusion Criteria:

* any spinal surgery in the past 12 months;
* evidence of nerve root, spinal cord, or cauda equina compression;
* severe spinal stenosis indicated by signs of neurogenic claudication, grade 3 to 4 spondylolisthesis, fibromyalgia, or systemic/inflammatory disorder;
* as well as any other current lower extremity musculoskeletal injury or contraindication to increasing physical activity (PA) levels.

The latter may include:

* any cardiorespiratory or other medical condition limiting exercise tolerance;
* history of serious psychological or psychiatric illness (mild depression eligible for inclusion); and/or
* pregnancy.
Alternative Dosing And Prevention of Transfusions (ADAPT)

ADAPT is a prospective cohort study at Jinja Regional Referral Hospital (JRRH) primarily to assess the effect of hydroxyurea on blood transfusion utilization and secondarily to determine the feasibility of PK-guided hydroxyurea dosing.

Hypothesis

* There will be a 50% reduction in the rate of blood transfusions received during the hydroxyurea treatment period compared with the pre-treatment period.
* A PK-guided starting dose will be generated for 80% of participants.
* Participants on PK-guided hydroxyurea treatment will require 25% fewer blood transfusions during their first year of hydroxyurea than those on dose escalation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with documented HbSS disease
* Age: ≥ 12 months and ≤ 10 years of age, at the time of enrollment
* Parent or guardian willing and able to provide informed consent
* Able to comply with all study related treatments, evaluations, and follow-up

Exclusion Criteria:

* Current hydroxyurea treatment (or within the past 6 months)
* Regular blood transfusions (6 or more within the past 12 months)
* Transfusion within the last 30 days (temporary exclusion)
* Known malignancy or other known chronic illnesses including but not limited to active tuberculosis, renal disease
* Current participation in other therapeutic clinical trials, or within 6 months of prior disease-modifying treatments
An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion.

The purpose of this study is to compare of difference in NRS scores from baseline to the completion of treatment (5 days) in patients with administration of morphine sulfate versus oxycodone hydrochloride.

5days, Multi-centers, Randomization, Open label, Parallel, Active Comparator, Phase 4 Study.

Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women aged 19 years or more
2. Patients with cancerous pain who are hospitalized or scheduled for hospitalization at Screening and not planned to be discharged during the study
3. Patients with mean moderate to severe pain over the past 7 days at Screening as verbally confirmed (NRS 4 or higher)
4. Subjects who voluntarily signed the Informed Consent Form for the study
5. Subjects who are capable of understanding details of the study and verbal communication on pain intensity

Exclusion Criteria:

1. Patients who reached the narcotic analgesic dose corresponding to the followings for cancerous pain treatment immediately prior to Screening (oral morphine dose 195mg/day, oral oxycodone dose 130mg/day, patch fentanyl dose 75μg/hour)
2. Patients with a medical history of hypersensitivity to an ingredient of oxycodone hydrochloride or morphine sulfate or other narcotic analgesics
3. Patients who have contraindications and cautions when study drugs administered.
Comparison of Bacteriostatic Saline to Buffered Lidocaine for Ultrasound Guided Hip Joint Injection Local Anesthesia

The purpose of this study is to compare infiltration pain and anesthetic efficacy between lidocaine and Bacteriostatic saline (BS) for ultrasound (US) guided intraarticular hip injections.

Local anesthesia is commonly used to reduce pain during joint injections, particularly for deep joints like the hip. Lidocaine is the most commonly used local anesthetic in most medical practices. It is well known that lidocaine infiltration itself is painful. Many strategies have been studied to minimize pain associated with lidocaine administration, including buffering, warming, and slowing infiltration rate. BS is an alternative local anesthetic that has been shown to be less painful when injected into subcutaneous tissues compared with lidocaine. However, BS use has not been widely implemented for local anesthesia, and it has not been studied in the context of joint injections.

Eligibility Criteria:
INCLUSION CRITERIA:

* age 18-75 years
* referred for US-guided intraarticular hip injections in the Mayo Clinic Sports Medicine Center, Physical Medicine \& Rehabilitation Clinic, or Musculoskeletal Clinic

EXCLUSION CRITERIA:

* chronic opioid use
* opioid use on day of procedure
* history of fibromyalgia or other diffuse chronic pain syndrome
* pain behavior during the clinical encounter as judged by the injectionist
* anesthetic administration time outside the designated 5-15 second time frame
Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease

The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are:

* Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation surgery?
* Does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision?

Researchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid.

Participants will:

* Receive the decision aid at the beginning of the evaluation process or towards the end
* Complete surveys at 5 visits (remote or in-person) over approximately 6 months


Eligibility Criteria:
Inclusion Criteria:

* Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado

Exclusion Criteria:

* Atypical Parkinsonism
* Diagnosis of Dementia
Troponin T as Risk Stratification Tool in Peripheral Arterial Occlusive Disease

Study hypothesis: elevated Troponin T is a marker of increased mortality in patients with peripheral arterial occlusive disease (PAOD).

Troponin T and I are established risk markers in patients with acute coronary syndrome. Only recently, troponin I was found to be elevated in patients with acute critical limb ischaemia. In another study, troponin I was associated with a higher mortality in patients with chronic critical limb ischaemia followed over two years. In a longitudinal study design we intend to follow all patients that were treated for symptomatic PAOD (Fontaine stages II-IV) from 01/2007 to 12/2007 in our department of angiology. Main outcome parameters are death and the occurrence of major vascular events and revascularization procedures during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic peripheral arterial occlusive disease
* aged \>/= 18 years

Exclusion Criteria:

* unstable angina or acute coronary syndrome \< 14 days
* percutaneous coronary intervention \< 14 days
* other interventions or disease associated with troponin T release (i.e., acute pulmonary embolism, aortic dissection, heart valve replacement, acute heart failure, non-ischemic cardiomyopathy, heart surgery, thoracic trauma, endocarditis, myocarditis
High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma

The purpose of this study is to test the safety of delivering the patients' own immune cells, called T cells, after the high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT).


Eligibility Criteria:
Transplant eligible patients will be eligible if criteria met per below.

Inclusion Criteria:

* Patients ≥ 18 years of age with aggressive B-cell non-Hodgkin lymphoma subtypes including, relapsed or refractory diffused large B-cell lymphoma (DLBCL), and transformed follicular lymphoma meeting at least one of the following criteria:

  * Bone marrow involvement at the time of relapse or refractory disease and not appropriate for allogeneic transplantation.
  * PET positive disease outside of one radiation port unless single-port disease treated with prior radiotherapy within the port, following \> or = to 2 cycles of salvage chemotherapy, still achieving chemosensitive status 1999 IWG criteria (section 12.2 and 12.383).
* Creatinine ≤ 1.5 mg/100 ml (or measured 24 hour creatinine clearance of ≥ 50 cc/min)
* Bilirubin \<2.0 mg/100 ml, AST and ALT \<3x the upper-limit of normal, PT and PTT \< 2x normal outside the setting of stable chronic anticoagulation therapy,
* Adequate cardiac function (LVEF\>40%) as assessed by ECHO or MUGA scan performed within 1 month of treatment.
* Adequate pulmonary function as assessed by DLCO of \> or = to 45% adjusted for hemoglobin.
* Life expectancy of \> 3 months.

Exclusion Criteria:

* Karnofsky performance status ≤ 70 (see appendix VI).
* Patients with other aggressive B-cell malignancies including, but not limited to: Burkitt lymphoma, transformed CLL/SLL and transformed marginal zone lymphoma that are not included in 6.1 inclusion criteria.
* Patients previously treated with autologous or allogeneic bone marrow or stem cell transplantation are ineligible.
* Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study.
* Uncontrolled bacterial, viral or fungal infection.
* Patients with HIV, active hepatitis B or hepatitis C infection.
Mechanistic Study of Subclinical Hypothyroidism In the Elderly

Subclinical hypothyroidism, defined as an elevated TSH in the setting of normal thyroid hormone levels, is a common diagnosis in the elderly. The purpose of this study is to examine the hypothalamic-pituitary-thyroid axis in men and women aged 70 years and older with persistent subclinical hypothyroidism. To evaluate the mechanism behind this condition, participants will undergo thyrotropin releasing hormone stimulation testing at 3 visits: baseline and while taking two different thyroid hormone preparations, levothyroxine and liothyronine. The investigators will also assess physiologic responses to these two different thyroid hormone medications to help us understand how the thyroid works in advanced age.


Eligibility Criteria:
Inclusion Criteria:

1. men and women aged 70 and older
2. TSH between 4.5 and 19.9 mU/L as an outpatient
3. ability to provide informed consent

Exclusion Criteria:

Laboratory Tests:

1. TSH \<4.5 mU/L or \>20 mU/L on repeat testing at least four weeks later or free T4 level outside the reference range
2. thyroid peroxidase (TPO) antibody positive
3. abnormal liver function tests (LFTs \>3 x upper limit of normal)
4. hemoglobin \<11 g/dL

Surgeries or Procedures:

1. thyroid surgery
2. pituitary surgery
3. bariatric surgery
4. bowel resection involving the jejunum and upper ileum
5. radioactive iodine therapy
6. radiation treatments to head or neck

Medical Conditions:

1. diagnosis of pituitary disease
2. diagnosis of amyloidosis, sarcoidosis, hemochromatosis
3. diagnosis of adrenal insufficiency
4. obesity with BMI \> 35 mg/kg2
5. history of stroke
6. chronic or ongoing angina, Class II or higher congestive heart failure, or uncontrolled hypertension with current blood pressure greater than 160/100
7. diabetes mellitus with hemoglobin A1C level greater than 8.0% in the past six months
8. celiac sprue, Crohn's disease, ulcerative colitis, Zollinger-Ellison syndrome
9. renal insufficiency with calculated glomerular filtration rate \<45 cc/min
10. cognitive impairment with Mini Mental State Exam\[30\] \<24/30
11. history of any seizures
12. unstable medical or psychological condition in the judgment of the principal investigator

Medications:

1. thyroid hormone preparations
2. antithyroid drugs
3. medications that interfere with the absorption or metabolism of thyroid hormone
4. medications that interfere with the TRH stimulation test
5. proton pump inhibitors
Evaluation of MST-188 in Acute Lower Limb Ischemia

The purpose of this study is to evaluate the safety and efficacy of MST-188 in subjects receiving catheter-directed rt-PA for acute lower limb ischemia and to evaluate whether treatment with MST-188 results in more rapid thrombolysis of the occlusion and more rapid tissue perfusion in the effected blood vessel.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥30 to \<80
* Symptoms consistent with ALI in target lower limb classified as Rutherford Category IIa or IIb
* Subject is hospitalized or in the process of hospitalization for the treatment of ALI
* Angiographic confirmation of thrombotic lower limb arterial occlusion

Exclusion Criteria:

* Prosthetic bypass graft occlusion within 1 month of implantation or autogenous graft occlusion within 6 months of placement
* Treatment with a thrombolytic agent within the last 48 hours
* Subject's laboratory results indicate inadequate organ function
* NYHA Class IV congestive heart failure
* Prior major amputation of the target limb
* Other complications or contraindications for receiving rt-PA, anticoagulants, or contrast media
Development and Validation of a Questionnaire for Assessing Activity Limitation in Patients With Lumbar Spinal Stenosis : The Cochin L3S Questionnaire

To develop and validate a questionnaire aiming at assessing specific activity limitation in patients with lumbar spinal stenosis (LSS).

Construction of the provisional questionnaire :

In a first step, semi-structured in-depth individual interviews were conducted from September 20, 2016 to January 4, 2017, in 20 patients fulfilling inclusion criteria to collect concepts related to LSS-specific activity limitation, participation restriction and patients' views about their condition. Thematic content was analysed using investigator triangulation. Overall, 57 items were generated by patients. 48 items were related to LSS-specific activity limitation and were used to construct the provisional 48-item Cochin L3S questionnaire (CL3S-48). Acceptability and understandability of the provisional CL3S-48 questionnaire was tested and consolidated in 10 patients with LSS.

Item reduction and validation of the questionnaire :

In a second step, 200 eligible patients according to our medical records will be informed by email of the purpose of the study, their non-opposition to the collection of data will be collected and patients will be invited to complete the following online self-administered questionnaires at baseline, 7 days and 3 months:

* Demographical and clinical characteristics at baseline
* Consolidated version of the CL3S-48 questionnaire
* Lumbar pain numeric rating scale (NRS)
* Radicular pain NRS
* Zurich Claudication Questionnaire (ZCQ) physical function subscale
* Oswestry Disability Index (ODI)
* Fukushima LSS Scale 25 (FLS-25)
* 12-Item Short Form Health Survey (SF-12)
* 1 anchoring question about patient acceptable symptom state
* 1 anchoring question about patient minimal clinically important difference at 3 months.

In a third step, the number of items will be reduced according to their metrological qualities. The psychometric properties of the new scale will be assessed and the scale will be consolidated to provide the final questionnaire

Eligibility Criteria:
Inclusion Criteria:

* patients ≥ 50 year old
* with lumbar spinal stenosis (LSS) according to medical records.

Exclusion Criteria:

* lumbar spinal surgery,
* cognitive impairment and inability to speak and/or understand French.
Efficacy of Topical 0.2% Xanthan Gum in Patients With Dry Eye

The purpose of this study is to evaluate the effect of an ophthalmic solution containing 0.2% xanthan gum in reducing symptoms and signs of dry eye as well as tear film markers of oxidative stress.

Oxidative stress is the result of an imbalance between the production of reactive oxygen species (ROS) and antioxidant systems . The eye is constantly exposed to solar UV radiation which is the major inducer of ROS production and therefore oxidative stress has been implicated in the pathogenesis of several eye disease, including dry eye. Xanthan gum is a complex exopolysaccharide utilized as a food additive. Its chemical structure shows a capacity to react with ROS indicating a role as an anti-oxidative molecule.

In the present study aging patients with dry eye will be enrolled. Signs and symptoms of dry eye as well as levels of oxidative stress in tear will be evaluated afte 30 days of treatment with eye drops containing carboxymethylcellulose or xanthan gum.

Eligibility Criteria:
Inclusion Criteria:

* Ocular Surface Disease Index \> 12\<23 and age \>59 yrs

Exclusion Criteria:

* contact lens wear and use of other ophthalmic solutions with the exception of artificial tears
Effect of Modified Complete Decongestive Therapy on Lower Limbs Fibrosis Post Cellulitis

this study will be designed to investigate the therapeutic benefits of kinesio tape in combination to complete decongestive therapy on limb volume , skin fibrosis, functional capacity ,ankle range of motion, lymphedema associated symptoms (pain, tightness, heaviness and hardness) and quality of life in patients with lower limbs fibrosis post cellulitis ,as well as finding out a physical therapy approach that has positive effect in treatment and care such cases which would enhance the physical therapy field.

Lymphedema patient need a rehabilitative intervention in two phases : decongestion phase to reduce edema volume , improve the skin extensibility and provide him a better quality of life, followed by the maintenance phase to keep the outcomes. When we use the kinesio tape in addition to the complete decongestive therapy, the patient will experience a better improvement in the edema volume and the skin extensibility within a shorter period of time , a lesser number of sessions and a lower cost. So, the patient will have a better quality of life and could be a productive person in the society.

Eligibility Criteria:
Inclusion Criteria:

The patient will be according the following criteria:-

1. Males and females with Lower limb lymphedema Stage 2.
2. Age will range from45 to 55years old.
3. BMI \<40 (kg/m2).
4. All patients will be clinically and medically stable when attending the study.
5. Patients free from any acute conditions.
6. Post cellulitis for at least 2 weeks.

Exclusion Criteria:

1. Unstable cardiovascular problems.
2. Altered mental status or poor cognition.
3. Lower limb ischemia (ABI ≤0.8).
4. Lower limb lymphedema stage 3\&4.
5. Acute deep venous thrombosis.
6. Any acute infection.
7. Patients with orthopedic or neurological limitations to exercise.
8. Any lower limb acute ulcer or arterial wounds.