cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Early Postpartum Intrauterine Contraception

This is a prospective clinical trial of ultrasound guided intrauterine contraception insertion 10 minutes - 48 hours after vaginal delivery of single infant. A six month follow-up will entail three follow-up visits; 4-6 weeks, 3 months, and 6 months.

The objective of this study is to measure intrauterine device (IUD) expulsion and the feasibility of conducting a future clinical trial to evaluate placement of the levonorgestrel-releasing intrauterine contraceptive 10 minutes - 48 hours postpartum.

This was a single arm cohort study of women who desired to receive a levonorgestrel releasing intrauterine system (LNG-IUS) within 48 hours of uncomplicated vaginal delivery.

Women were enrolled during a prenatal care visit when they reported they desired to use the LNG-IUS after the birth of their infant.

Forty women stated enrolled in the study prior to labor, and baseline data were obtained. After delivery 29 women remained both interested in the study and were still eligible to receive the LNG-IUS prior to discharge from the hospital.

Of the 29 women who received the LNG-IUS prior to discharge from the hospital 11 women had an LNG-IUS expulsion prior to 6 months postpartum.

Eligibility Criteria:
Inclusion Criteria:

* Currently pregnant with a single gestation of at least 27 completed weeks estimated gestational age, with no complications of pregnancy including, but not limited to, preeclampsia, non-gestational diabetes, anemia.
* Desires to use intrauterine contraception (IUD) after delivery
* Anticipates having a vaginal delivery
* No intention to leave the area 7 months after enrollment
* Able to consent to participate in the study in English
* Has no known uterine anomalies
* Has no allergies to any components of the intrauterine contraception

Exclusion Criteria:

* Prior cesarean delivery
* Having been treated for pelvic inflammatory disease within 3 months prior to the start of the pregnancy
* Allergic to betadine
* Allergy to lidocaine
* Medical or personal conditions which in the judgment of study staff contradict participation in the study
* Any contraindications to use of the levonorgestrel-releasing intrauterine contraceptive system which includes: known or suspected breast carcinoma, acute liver disease or liver tumor, history of ectopic pregnancy, cervical cancer or carcinoma in situ
* After enrollment, and after delivery of the infant but before IUD insertion subjects will be excluded by checking with the attending obstetric physician and/or obstetric medical chart for the following:

  * Endometritis or chorioamnionitis during the intrapartum period
  * Membranes ruptured for greater than 24 hours prior to delivery
  * Fever greater than or equal to 38C
  * The need to use additional medications other than pitocin and/or misoprostol to control postpartum bleeding
A Muti-Center Study Comparing 3 Procedures for Bi-level Cervical Spondylosis

A muti-center study to compare the safety and efficacy of anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery for bi-level cervical spondylosis.

Patients with bi-level cervical spondylosis undergoing anterior cervical discectomy and fusion, cervical artificial disc replacement and hybrid surgery in the muti-center hospital were retrospectively reviewed.The safety and efficacy were evaluated based on scores of the Neck Disability Index (NDI), visual analog scale (VAS), and Japanese Orthopedic Association (JOA) and the range of motion of both operative segments and adjacent segments,not only in the preoperative,but also in the 5 days,6 months,12 months and the 5 years after surgery.

Eligibility Criteria:
Inclusion Criteria:

* (1) Cervical degenerative pathology with symptomatic radiculopathy or myelopathy at two consecutive segments from C3 to C7 which not responding to conservative treatment for 6 weeks. (2) Preoperative magnetic resonance imaging (MRI), complete cervical spine radiography and computed tomography (CT) showed anterior compressive pathology. (3) None or slight osteophyte at the posterior edge of vertebrae. (4) None significant spinal stenosis or posterior compression.

Exclusion Criteria:

* ossification of the posterior longitudinal ligament (OPLL), tumor, fracture, infection, history of cervical spine surgery, narrowing of the spinal canal, and any serious general illness. Cases with one or more than two segments requiring treatment were also excluded.
The Genetics of Kidneys in Diabetes (GoKinD) Study

Kidney disease in diabetes (diabetic nephropathy) tends to run in families. It is likely, therefore, that there are genes that predict or are associated with either getting or not getting diabetic nephropathy. The GoKinD Study will provide clinical information and DNA for investigators to look for these genes. Evaluation will be performed and DNA obtained from approximately 1100 diabetic persons with kidney disease and 1000 diabetic persons without kidney disease. In some cases, samples for DNA will also be obtained from the parents of these subjects. Clinical information and DNA will be coded so that individuals cannot be identified, but the DNA can be linked to the clinical data from the individual. Multiple investigators will be able to use this genetic material to test hypotheses about the genetics of kidney disease in diabetes.


Eligibility Criteria:
Inclusion criteria:

Type 1 diabetes mellitus with or without diabetic nephropathy; 19-54 years old; no other kidney disease
Evaluation of Blood Glucose Meter Systems

The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

The purpose of this study was to evaluate the performance of a Bayer Blood Glucose Monitoring System (BGMS) and four additional Blood Glucose Monitoring Systems (BGMS) from other manufacturers. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems were evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some samples were tested from subject fingertips. Additionally, some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels.

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age or older
* Willing to complete all study procedures

Exclusion Criteria:

* Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
* Hemophilia or any other bleeding disorder
* Pregnancy
Assessment of Tramadol as a Treatment for Opioid Addiction

Opioids are one of the most commonly abused drugs among individuals who seek treatment for drug abuse. Thus, it is necessary to develop new treatments for opioid addiction. The purpose of this trial is determine whether tramadol is effective in treating opioid dependent individuals.

This human laboratory study will test the effects of tramadol as a step in its development as a new treatment for opioid dependence. Tramadol is a moderate mu agonist opioid that may produce low levels of opioid physical dependence. Tramadol's capacity for producing physical dependence has not been systematically studied in humans. It is important to quantify tramadol, as it provides a measure of its opioid agonist effects. This would also be informative in regards to the abuse liability of tramadol when used as an analgesic (as currently marketed), or when used in the treatment of opioid addiction (as proposed in this study). The purpose of this trial is to evaluate the level of physical dependence as well as blockade efficacy produced by chronic maintenance on oral tramadol in opioid dependent individuals.

Participants will be randomly assigned to receive different doses of tramadol or placebo for up to six weeks. Experimental sessions will take place up to three times per week during the treatment period. During challenge sessions, participants will receive an injection; four different kinds of effects may occur in a session following this injection. First, no effect may occur (a placebo). Second, an opioid agonist effect may occur (opioid agonists include heroin, morphine, hydromorphone, tramadol, and methadone), which may cause the participant to feel "high." Third, an opioid antagonist effect may occur (e.g., naloxone, naltrexone), which may cause the participant to feel a sense of opioid withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* Currently opioid dependent

Exclusion Criteria:

* Significant medical illness (e.g., diabetes mellitus)
* History of seizure
* Current sedative or alcohol dependence
* Pregnant or breastfeeding
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus

The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.


Eligibility Criteria:
Key Inclusion Criteria:

* Clinical diagnosis of SLE by ACR criteria.
* Active SLE disease.
* Autoantibody-positive.
* On stable SLE treatment regimen.

Key Exclusion Criteria:

* Pregnant or nursing
* Have received treatment with any B cell targeted therapy.
* Have received treatment with a biological investigational agent in the past year.
* Have received IV cyclophosphamide within 180 days of Day 0.
* Have severe lupus kidney disease.
* Have active central nervous system (CNS) lupus.
* Have required management of acute or chronic infections within the past 60 days.
* Have current drug or alcohol abuse or dependence.
* Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
Steroids in Total Knee Arthroplasty

The purpose of this study is to evaluate if the use of two small doses of intravenous (IV) steroids around the time of knee replacement surgery decrease a patient's pain or use of pain medication. The investigators will also determine if the subjects receiving the steroid will have better pain control and better postoperative outcomes after their surgery.

Adequate pain control after total knee arthroplasty (TKA) is of great importance not only to maximize patient comfort, but also to ensure optimal outcomes after surgery. This study is designed to assess whether the use of two small doses of intravenous (IV) steroids around the time of surgery decrease a patient's pain or use of pain medication. Secondly, the investigators will also determine if the use of these steroids as part of a multimodal pain management strategy leads to improved patient outcomes, including pain, nausea and vomiting, knee function and length of stay in the hospital after surgery. The study will compare the effect of two different doses of IV dexamethasone given preoperatively before TKA, when compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary total joint arthroplasty of the knee
* Adult patients ages 18-100 years
* Patients must have smart phone and/or device for app usage

Exclusion Criteria:

* Current chronic steroid use
* Patients undergoing revision knee surgery
* Patients ambulating preoperatively with assistive devices
* Patients with avascular necrosis of the operative knee
* Patients with a history of an adverse reaction to glucocorticoid steroids
* Patients unable to provide informed consent
* Patients with inflammatory arthritis
* Prisoners
* Current smokers
* Patients \<18 years of age
* Any patient with a complicated postoperative course that requires transfer to the Intensive Care Unit (ICU) or to another facility for further management will be removed from the study.
* Any contraindication that would prevent the patient from being treated with the standard multimodal postoperative pain management regimen History of infection of surgical knee.
* Patients with diabetes.
* Patients that have an intolerance to Toradol.
* Patients that do not have smart phone and/or device for app usage
Social Connections and Healthy Aging (The Senior Connection)

This randomized trial compares peer companionship to care-as-usual in primary care on the outcome of risk for suicidal behavior in late life. The investigators hypothesize that older adults assigned to receive peer companionship will report greater social connectedness and less death and suicidal ideation compared to older adults assigned to care as usual.

There is a pressing need for interventions that reduce risk for suicide in later life. Older adults in the U.S. have the highest rate of suicide and are the fastest growing segment of the population. The investigators can anticipate a large rise in the number of older adults who die by suicide in coming decades. This application is in response to RFA-CE-10-006. Consistent with the CDC's key strategy of reducing suicide by promoting connectedness, our long-term goal is to reduce late life suicide-related morbidity and mortality by leveraging the resources and expertise of the aging services provider network (ASPN) to address unmet social needs of community-dwelling older adults. Our objectives with this proposal are (1) to examine whether linking socially disconnected seniors with peer supports through the Retired and Senior Volunteer Program (RSVP) is effective in reducing risk for suicide, and (2) to test an hypothesized mechanism for the association of social disconnectedness and suicidal ideation and behavior informed by the Interpersonal Theory of Suicide.

The investigators will recruit 400 primary care patients (200 men and 200 women) over age 60 years who endorse feeling lonely and/or as if they are a burden on others. They will be randomly assigned to either of two conditions. Those assigned to The Senior Connection (TSC) will either be paired with a peer companion or, if they prefer and are eligible, be trained and placed as a peer companion for others by RSVP. The comparison group will receive no further intervention ("care-as-usual" \[CAU\]). Subjects will be followed for up to 24 months with repeated in-home (baseline, 12, and 24 months) and telephone assessments (3, 6, and 18 months).

Eligibility Criteria:
Inclusion Criteria:

* Age 60 or older
* Primary Care Patient
* Endorses feeling lonely and/or like a burden in the the past two weeks

Exclusion Criteria:

* Positive dementia screen
* Current alcohol abuse
* Psychosis
* Suicidal ideation with intent to act (current or past month.)
Behavioral Intervention to Increase Physical Activity in Patients With Asthma

The health benefits of physical activity (PA) are well documented and include improving in cardiovascular, obesity, mental health and all-cause mortality. Although higher levels of activity in patients with asthma are also associated with better outcomes, patients still avoid physical activity due to concern about exacerbating their asthma symptoms by the exercise induced bronchoconstriction (EIB), sustaining a vicious cycle of inactivity and worse asthma control. Many studies have reported the benefits of supervised exercise training on several asthma outcomes, such as exacerbations, asthma control, cardiopulmonary fitness, airway inflammation and psychosocial symptoms; however, the translation of the improvements in the exercise capacity into increments in PA levels is less evident and still controversial. Therefore, the hypothesis of this study is that behavioural interventions using strategies based on well-established psychosocial models are effective in increasing physical activity levels and decrease sedentary behaviour in adults with asthma, which will be associated with improvements in the asthma control.

This is prospective and randomized controlled trial (RCT) with 2 arms and blinded outcome assessments. Forty-six moderate or severe patients with asthma under optimized medication will be randomly assigned (computer-generated) into either Control Group (CG) or Intervention Group (IG). Both groups will receive similar educational program. However, only the IG will be submitted to the behavioral intervention through physical activity counseling program combined with a monitoring-and-feedback tool aiming to increase physical activity levels (total of 8 weekly goal-setting consultation, face-to-face, each lasting 40 minutes). Before and after the interventions, clinical control of asthma, physical activity levels, health-related quality of life, asthma exacerbation, levels of anxiety and depression symptoms and anthropometric indices will be assessed. Data about onset of asthma, comorbidities, lung function and asthma medication will be collected from the patient's medical record. The data normality will be analyzed by Kolmogorov-Smirnov, and a two-way ANOVA with repeated measures with appropriate post hoc of Holm-sidak will be used to compare inter and intra-groups differences. The significance level will be set to 5% for all tests.

Eligibility Criteria:
Inclusion Criteria:

* Asthma moderate and severe with diagnosed according to the Global Initiative for Asthma (GINA) 2018
* Poorly controlled asthma (ACQ score \> 1.5)
* Sedentary (\< 150 min of moderate to vigorous physical activity/week)
* Medical treatment, for at least 6 months
* Clinically stable (i.e., no exacerbation or changes in medication for at least 30 days)

Exclusion Criteria:

* Cardiovascular, musculoskeletal or other chronic lung diseases
* Active Cancer
* Pregnant
* Uncontrolled hypertension or diabetes
* Current smoker or ex smoker (\>10 pack-years)
* Psychiatric disease or cognitive deficit
Gain of Keratinized Mucosa Around Teeth and Dental Implants Using a Combination of Strip Gingival Graft and Acellular Dermal Matrix

This study is to compare the two techniques to achieve change in the tissue quality at areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix (ADM) (SGG+ADM).

This investigation is a randomized controlled trial of two techniques to achieve change in the tissue quality at areas of lack of Keratinized Tissue (KT) using soft tissue grafting with autogenous graft material (Free Gingival Graft)(FGG) vs Strip gingival graft with acellular dermal matrix (ADM) (SGG+ADM). To evaluate to determine if either grafting technique (FGG vs SGG+ADM) demonstrates superiority in clinical (amount of KT increase, tissue thickness increase, and practitioner-assessed esthetics) and patient-centered outcomes (pain, swelling, change in daily activities, and patient-assessed esthetics) in a controlled study.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* At least 18 years old
* Able to read and understand informed consent document
* Patients with teeth/implants lacking keratinized tissue.
* Must be a patient of the UAB Dental School
* Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)

Exclusion Criteria:

* Non-English speaking
* Less than 18 years old
* Smokers/tobacco users (\>10 cigarettes/day)
* Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
* Presence of active periodontal disease
* Previous soft tissue grafting at the site(s) to be treated
fMRI and NIRS Imaging for Traumatic Brain Injury

Background:

- The amount of blood flowing in brain areas goes up when those areas are being used for activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a common way of measuring blood flow in the brain. Near infrared spectroscopy (NIRS) can also be used to study blood flow in the brain. However, NIRS has not been used as often as fMRI. Researchers want to compare fMRI and NIRS to see whether they give similar results. These studies will be used to look at people who have had a traumatic brain injury.

Objectives:

- To test how well NIRS measure changes in blood flow in the brain after a traumatic brain injury.

Eligibility:

* Individuals between 18 and 60 years of age who have had a traumatic brain injury.
* Healthy volunteers at least 18 years of age.

Design:

* Participants will be screened with a physical exam and medical history. Researchers may ask to see brain images during from previous MRI scans.
* Participants will have a NIRS scan of the brain. They will be asked to do certain tasks while inside the scanner. These tasks will involve responding to images that appear on a screen.
* Treatment will not be provided as part of this study.

The goal of this study is to be able to assess frontal lobe function in a rapid, objective, and standardized way, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in mild traumatic brain injury, where objective measures are needed, and would greatly expand the capacity to make such assessments in standard clinical practice.

Our goal is to recruit 100 subjects total in two groups of age, gender, and education matched subjects, as follows: TBI (n = 50) and non-TBI (n = 50).

The subject will be asked to perform 2 computer-based cognitive tests while the fNIRS device is in place. The fNIRS sensor pads will record changes in blood oxy/deoxy hemoglobin concentrations in the underlying cortex. Data will be stored for post processing analysis.

The main outcome measures will be: 1) a correlation of the fNIRS results between the TBI and non-TBI groups; 2) a correlation of the fNIRS results with the severity of the TBI within the TBI group. Finally, we plan to compare individual measurement from TBI patients with the healthy group.

Eligibility Criteria:
* INCLUSION CRITERIA:

Healthy population

- Age 18 to 60, inclusive.

Traumatic brain injuries population

* Age 18 to 60.
* Have a recorded past traumatic brain injuries rated in the Glasgow Coma Scale between 9 and 15

EXCLUSION CRITERIA:

* Pregnancy
* History of hypertension
* History of any disease of the central nervous system
* Current use of sedating medication, including antihistamines
* Subjects with any of the following will be excluded from MRI testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing due to the possible dangerous effects of the MRI magnet upon metal objects in the body.