cyrilzakka/clinical-trials huggingface dataset:
Epidural Steroid Injection Versus Epidural Steroid Injection and Manual Physical Therapy and Exercise in the Management of Lumbar Spinal Stenosis

Lumbar spinal stenosis (LSS) is a prevalent and disabling condition in the rapidly growing aging population. People with LSS often have a substantial physical and psychosocial burden as well as significant healthcare costs affecting both the individual and society. It has been reported that patients with LSS over the age of 65 are more likely to undergo spinal surgery than any other condition with an estimated total annual inpatient expense of one billion. Individuals undergoing surgical treatment for LSS tend to be older, therefore operative morbidity and mortality are a particular concern. Functional benefit derived from conservative treatment may increase the health and quality of life for individuals suffering from LSS and avoid or delay the need for surgery in some subjects. As the population continues to age, identifying effective non-surgical treatment options for older patients with LSS is an important research priority. Ultimately, the information gained from this study will help fill a significant void in medical literature regarding non-surgical options for this patient population.


Eligibility Criteria:
Inclusion Criteria:

1. Lumbar spinal stenosis unidentified by MRI or CT scan and interpreted by a radiologist independent of the study. The criteria of Boden et al will be used to define LSS on MRI: non-discogenic loss of signal in the epidural fat with compression of neural tissues.
2. Chief complaint of pain in the low back, buttock, and/or lower extremity. The patient must have LE symptoms consistent with neurogenic claudiation.
3. Patient-reported inability to walk greater than ¼ mile due to lower extremity pain and/or cramping.
4. Rates sitting as a better position with respect to symptom severity compared to standing or walking.
5. Consent of the patient to undergo education, epidural steroid injection(s), and attend specified physical therapy sessions.
6. Individuals with no language barrier, that are cooperative, have transportation to the Spine Center, and who sign an informed consent form.
7. Age greater than or equal to 50 years.

Exclusion Criteria:

1. Patients with organic brain syndrome or dementia.
2. Severe vascular, pulmonary or coronary artery disease which limits ambulation.
3. Recent myocardial infarction (within last 6 months).
4. Spondylolisthesis requiring surgical fusion (i.e., greater than 5mm of slippage).
5. Previous spinal surgery that included fusion of two or more vertebrae.
6. Severe osteoporosis as defined by multiple compression fractures or a fracture at the same level as the stenosis.
7. Metastatic cancer.
8. Excessive alcohol consumption or evidence of non-prescribed or illegal drug use.
Topiramate for Alcohol Use in Posttraumatic Stress Disorder

Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Ages 21-64
* Diagnosis of PTSD via a score of 50 or higher on the Clinician Administered PTSD Scale (CAPS)
* Alcohol abuse or dependence per diagnosis in the medical record -or- by consuming more than 35 standard drinks per week over the previous 4 weeks as measured by the Timeline Follow-Back Interview
* A desire to reduce drinking behavior
* Any Race/Ethnicity

Exclusion Criteria:

* Currently taking a carbonic anhydrase inhibitor (e.g. zonisamide, acetazolamide, dichlorphenamide)
* Currently taking or have taken in the previous 3 months: acamprosate, naltrexone, disulfiram, topiramate
* Change in benzodiazepine dose within the previous 3 months
* Change in other (non-benzodiazepine) medication dose within the last 4 weeks
* Seizure disorder documented in the medical record
* Head trauma with loss of consciousness for greater than 30 minutes -or- a diagnosis of post-concussive syndrome documented in the medical record
* Suicide attempt within the previous 3 months or suicidal ideation within the previous 4 weeks
* A history of kidney stones
* A history of glaucoma
* ALT or AST liver enzymes elevated more than twice the upper limit of normal
* More than 4 unsuccessful attempts at inpatient alcohol treatment
* Medically unstable (including significant hypertension despite adequate treatment)
* A history of delirium tremens ("DTs") or alcohol withdrawal seizure
* Compulsory treatment to avoid legal consequences (e.g. imprisonment)
* Currently in a setting without access to alcohol (e.g. locked inpatient unit)
Clinical Trial of Tensegrity Prosthetics K3 Promoter Foot Prosthesis

The purpose of this clinical trial is to determine if the experimental Tensegrity prosthetic foot offers a reduction of the amount of oxygen used while walking, if stability is improved over current prosthetic feet, and whether the experimental device actually increases activity in amputees.

Tensegrity Prosthetics' objectives are to test whether the K3 Promoter prosthetic foot affects walking efficiency or stability in trans-tibial unilateral amputees when compared to their current prostheses. The primary objectives are to determine if the experimental foot changes Cost of Transport (ml O2/kg/meter) or Stride Time Variability compared to an amputee's current prosthesis. Cost of Transport is an indicator of metabolic efficiency and Stride Time Variability indicates how likely a person is to fall. Oxygen consumption and stride time will be collected on a treadmill at the Gait and Motion Lab at the University of Colorado in Boulder.

Eligibility Criteria:
Inclusion Criteria:

1. K2 or K3 classification based on current prosthetic device.
2. Males and females ≥ 18 years of age
3. Willing and able to sign informed consent
4. Able to read, write, and speak English
5. Documented to have a unilateral trans-tibial amputation
6. Actively utilizing a definitive prosthesis for at least 12 months
7. Utilizing current prosthetic foot for at least 3 months
8. Cognitively functional, in the opinion of the prosthetists'
9. Able to maintain a good gait on their existing limb for approximately 45 minutes
10. have a healthy residual limb in good condition
11. have a socket with a good, trouble-free fit on their residual limb

Exclusion Criteria:

1. Significant ulcers or infections associated with a compromised circulation of the other lower limb
2. Intermittent Claudication or Critical Leg Ischemia in the non-amputated leg
3. K0, K1or K4 Classification
4. Irreducible, pronounced knee or hip flexion contractures
5. Bilateral amputations
6. Use of a walker for ambulation
7. Severe arthritis that would limit the ability to stand without pain or discomfort or the subject's ability to ambulate is limited by symptoms other than the prothesis (e.g., shortness of breath, fatigue, angina, arthritis, etc.). If, in the opinion of the investigator, the subject were to improve their ability to ambulate from the K3 Promoter to the extent that his or her walking would then be limited by a symptom other than the prothesis, the subject should not be enrolled
8. Any other clinically significant medical or psychiatric condition that in the opinion of the Investigator could impact the subject's ability to successfully complete this trial
9. Advanced neurologic disorder
10. Severe congestive heart failure, angina pectoris, or obstructive pulmonary disease
11. Use of medication that causes impaired balance or judgment
Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.

The investigators compared the effectiveness of a lifestyle intervention program carried out by trained professionals versus standard unstructured information on healthy lifestyle given by the family physicians in ameliorating the metabolic pattern of adults with multiple metabolic and inflammatory abnormalities.

Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. It is unknown if a less intensive program might also be effective in the general population.

The investigators' aim was to compare the effectiveness of two different modalities that recommend a healthier lifestyle to reduce multiple metabolic abnormalities-a lifestyle intervention program with general recommendations carried out by trained professionals and standard unstructured information given by the family physician-in a dysmetabolic population-based cohort.

All subjects aged 45-64 (n=1,877) from 6 family physicians, representative of the local Health Districts of Asti (Northern Italy), were contacted. A metabolic screening was carried out on 1,658 subjects (88.3%) who accepted to participate.

Out of those subjects, 375 patients had either the metabolic syndrome (MS) or two components of the MS plus high-sensitivity C-reactive protein (CRP) serum values ≥3 mg/L, the cutoff point that differentiates high-risk groups for future cardiovascular events, and did not have any of the exclusion criteria.

Then,187 were randomly allocated to the intervention arm and 188 to the control arm; 18 and 22 individuals refused to participate, respectively. Finally, 169 patients were assigned to the lifestyle intervention program carried out by trained professionals (intervention arm) and 166 to the standard, unstructured information given by the family physicians (control arm). All participants received verbal, not-written, information, emphasizing the importance of a healthy lifestyle from their family physicians, who had previously participated in 3 meetings on standard practice lifestyle recommendations. No further individualized programs were offered to the control arm.

The intervention arm received detailed verbal and written individualized diet and exercise recommendations from trained professionals during five 60-min sessions covering diet, exercise, and behavior modifications (the first was a one-to-one meeting, the following were group sessions).

Anthropometric measurements and blood samples were collected from all participants at the beginning and at the trial end, after 1-year.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 45-64 from 6 family physicians, representative of the local Health Districts of Asti (Northern Italy)
* Presence of the metabolic syndrome (MS) or hs-CRP\>3mg/l and 2 components of the MS

Exclusion Criteria:

* diabetes, cardiovascular diseases, chronic liver or kidney disease, advanced cancer
The Clinical Outcomes of the Modified Broström vs Anatomic Reconstruction Operation in CLAI and GJL

Investigators designed this prospective cohort study to compare the clinical outcomes of modified Broström operation and anatomical reconstruction for the treatment of CLAI and GJL.

The modified Broström operation is still the first line to treat chronic lateral ligament instability (CLAI). However, some studies indicate the modified Broström operation may bring a higher rate of re-injury in generalized joint laxity (GJL). Anatomical reconstruction was reported to generate similar results and less rate of re-injury compared in patients with CLAI. However, the clinical outcomes of the two operations are not discussed in CLAI and GJL. So, investigators designed this prospective cohort study. The primary outcomes are Karlsson, Foot and Ankle Outcome Score (FAOS), and Foot and Ankle Ability Measure (FAAM) scores. The secondary outcomes are anterior displacement and talar tilt angle in stress radiography, the rate of re-injury.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of lateral ankle pain and instability Beighton score ≥4 Age with 18 to 60 years

Exclusion Criteria:

Patients with an acute or subacute ankle injury (within 3 months) Injury of the deltoid ligament Alignment of lower extremity greater than 5 degrees Fractures of the lower extremity Stage III or IV osteoarthritis Patients who refused to participate in the study
Effects of Exercise Training on Health-related Quality of Life in Patients Undergoing Treatment of Unresectable Metastatic Colorectal Cancer

The primary objective of this trial is to compare the effects of 18 weeks structured exercise training versus on control on healt-related quality of life in patients with unresectable mCRC.


Eligibility Criteria:
Inclusion criteria:

- Adults (≥18 years of age) schduled to undergo chemotherapy for the treatment of unresectable metastatic colorectal cancer.

Exclusion criteria :

* Pregnancy.
* A life expectancy of \< 6 months.
* Absolute contraindications to maximal exercise, as per the recommendations by the Danish Society of Cardiology.
* ECOG (Eastern Cooperative Oncology Group) performance status \> 2.
* Inability to understand the Danish or English language.
* Engagement in structured moderate-to-high aerobic exercise training for \>30 min \>1 times/week for the past 3 months at the time of inclusion.
Metformin Compared to Glyburide in Gestational Diabetes

Our hypothesis is that metformin and glyburide will have equal efficacy in controlling blood glucose in gestational diabetics with no increase in adverse maternal, fetal or neonatal outcomes.

Pregnant women are screened with a one hour 50g glucose challenge. Women with values of 130 mg/dl or greater are then given a 100g glucose tolerance test. Two abnormal values are diagnostic of gestational diabetes. all women are initially counseled on diet and exercise. Women who fail to maintain a fasting of \<105mg/dl and 2 hr postprandial \< 120 mg/dl are offered participation in the study. Women were randomized to either metformin or glyburide via a computer generated randomization. Women who fail to meet glycemic goals after receiving the maximum dose of study medication were considered treatment failures and insulin therapy was initiated.

Eligibility Criteria:
Inclusion Criteria:

* Gestational diabetes not controlled with diet and exercise

Exclusion Criteria:

* history of alcohol misuse
* history of drug misuse
* Chronic hypertension requiring medication
* Renal failure
* Hepatic disease or dysfunction
* Known fetal anomaly
* Inability to give consent
* known allergy to metformin or glyburide
Complement Inhibition: Attacking the Overshooting Inflammation @Fter Traumatic Brain Injury

Severe Traumatic Brain Injury (s-TBI) is a major cause of death and disability across all ages. Besides the primary impact, the pathophysiologic process of major secondary brain damage consists of a neuroinflammation response that critically leads to irreversible brain damage in the first days after the trauma. A key catalyst in this inflammatory process is the complement system. Inhibiting the complement system is therefore considered to be a potentially important new treatment for TBI, as has been shown in animal studies. This trial aims to study the safety and efficacy of C1-inhibitor compared to placebo in TBI patients. By temporarily blocking the complement system we hypothesize limitation of secondary brain injury and more favourable clinical outcome for TBI patients due to a decrease in the posttraumatic neuroinflammatory response.


Eligibility Criteria:
Inclusion Criteria:

* Age at admission ≥ 18 years and \< 65 years;
* Clinical diagnosis of traumatic brain injury with GCS \< 13 (with intracranial deviations);
* Catheter placement for monitoring and management of increased ICP for at least 24 hours;

Exclusion Criteria:

* A clear, non-traumatic cause of low GCS (e.g. toxic, cardial) on admission;
* Not expected to survive more than 24 hours after admission;
* Brain death on arrival in the participating centers;
* Severe pre-trauma disability, defined as being dependent on other people;
* Known prior history of sensibility to blood products or Cinryze;
* Patients with a history of hereditary angioedema;
* Patients with a history of thrombosis;
* Pregnant women.
Comparing Pre-Anesthesia Evaluation Via Telemedicine Versus in Person for Surgical Patients at Moffitt Cancer Center

This is a randomized controlled trial of patients scheduled for hysterectomy or prostatectomy surgeries who undergo a pre-anesthesia evaluation at Moffitt Cancer Center PreAnesthesia Testing (PAT) clinic. Traditionally, patients who met certain criteria based on type of surgery or comorbidities would undergo an in-person evaluation in our clinic. In order to make our patient's care more convenient and accessible, investigators have introduced telemedicine evaluation for a certain subset of patients meeting specific criteria. Investigators aim with this randomized trial to investigate the hypothesis that telemedicine pre-anesthesia evaluation is non-inferior to in-person evaluation from the standpoint of day of surgery cancellation rate.


Eligibility Criteria:
Inclusion Criteria:

* Able to speak and read English
* Able to provide signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Presurgical patients at Moffitt Cancer Center scheduled to undergo any type of hysterectomy/salpingo-oophorectomy or prostatectomy surgeries.
* Possesses appropriate equipment (i.e., computer, tablet, smartphone) to undergo telemedicine evaluation.

Exclusion Criteria:

* Patients with documented or observable significant cognitive barriers, hearing, or speech impairment. Examples include a patient who is not alert or oriented, who is unable to sign his or her own surgical consent due to cognitive issues or who cannot understand and repeat back to study coordinator reason for study. If these barriers will not be an issue for a video phone call and can be reasonably accommodated, we will do so. However, our telemedicine technology is still very basic, and these patients may be more comfortable communicating with providers and expressing their needs during an in-person visit
* Surgery 3 days or less away from clinic visit. As in-person assessment is the gold standard, we need to allow some time in case a patient cannot work the technology for a telemedicine visit or an issue comes up where visit needs to be converted to in-person.
* Out of state patients as there are currently medical licensing concerns with conducting telemedicine on patients physically located out of state during the visit.
* Determined to be ineligible for surgery during evaluation
Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery

In endoscopic sinus surgery a clear surgical field of view is a very important aspect for good surgical outcome. This study is to evaluate the preoperative preparation to acquire best surgical field of view by comparing between the use of topical adrenaline and the use of combination of topical adrenaline with infiltration of 1% lidocaine with adrenaline in patients scheduled for endoscopic sinus surgery for rhinosinusitis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with recurrent acute or chronic rhinosinusitis recalcitrant to medical treatment and scheduled for endoscopic sinus surgery

Exclusion Criteria:

* Patients who have asymetrical disease on the two sides (Lund Mackay score difference more than 2)
* Patients who have endoscopic sinus surgery for treatment of tumor or disease other than sinusitis
* Patients with underlying uncontrolled hypertension
* Patients with bleeding disorder or are unable to discontinue antiplatelet or anticoagulant before the surgery
* Patients who are allergic to adrenaline or to xylocaine
Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men

This clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.

PRIMARY OBJECTIVES:

I. Evaluate the sensitivity \& specificity, predictive positive value (PPV), \& predictive negative value (PNV) (test characteristics) \& cellularity, beta-globin, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), \& protein (quality measures) from nylon-flocked (NF)- \& Dacron-swab protocols to detect biopsy-detected high-grade anal intraepithelial neoplasia (HG-AIN) \& human papillomavirus (HPV)-infections, using randomized-controlled study design.

II. Evaluate the test characteristics for anal cancer screening algorithms that incorporate sequentially or simultaneously performed high-threshold molecular HPV tests, with \& without cytology, to predict HG-AIN.

III. Evaluate the cost-effectiveness \& relative cost of single- \& multiple-test anal cancer screening algorithms.

OUTLINE:

Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Papanicolaou (Pap) staining, HPV genotyping, and polymerase chain reaction (PCR).

Eligibility Criteria:
Inclusion Criteria:

* Males who self-identify as having had or currently having sex with men; both human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects are being enrolled
Effects of Vasopressor on the Graft Blood Flow in TRAM

The purpose of this pilot study is to investigate whether two major vasopressors (norepinephrine vs. phenylephrine) used for treatment of hypotension during breast reconstruction with free flap transfer surgery have different effects on blood flow of the flap vessel measured by transit time flowmetry. Since there are few prior studies that compared the effects of these two vasopressors on the blood flow of the flap, this study will be conducted in the form of a pilot study in order to establish the evidence for the future randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status Classification Grade 1-3
* Patients with an ECOG score of 0 or 1 when selecting a subject for the study
* Patients who can provide written consent to participate in clinical trials
* Patients requiring the use of vasopressor because the mean arterial pressure is not maintained more than 65 mmHg during surgery

Exclusion Criteria:

* Patients with peripheral arterial diseases
* Patients with allergic history to study drugs
* If surgery on other areas is scheduled at the same time or is an emergency operation
* Patients with history of previous abdominal surgery involving the flap donor site
* Pregnant
* If there are other major medical or psychiatric disorders that may affect treatment response
* Left ventricular ejection fraction \< 30% or with a history of arrhythmia that is not controlled by medication
* Refuse to participate