cyrilzakka/clinical-trials huggingface dataset:
Promoting Self-Management in Low Income African Americans Living With Hypertension

The specific study aims are to: 1) examine differences between an Ecological Nursing Case Management (ENCM) treated group and a comparison group on self-efficacy, SM behaviors, and health status to establish effect sizes needed for a future large randomized controlled trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3) examine moderating effects of gender and perceived stress on the intervention effect. This is a two-group randomized experimental study with repeated measurements. Clients in the treatment group (n=25) will receive the individualized ENCM and those in the comparison group (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6 months to capture the immediate, short and longer term effects of the intervention.

Health outcomes of chronically ill low-income adults are costly in both fiscal and human terms. Although advances have been made in understanding how nurse case management (NCM) can contribute to self-management (SM) behaviors, the factors that contribute to sustained SM behaviors in low-income African American populations are not well understood. This study will examine the impact of Ecological Nurse Case Management (ENCM) on self-management behaviors, health status, and self-efficacy of poor, chronically ill, African American adults. In addition, we will explore moderating effects to determine if the ENCM intervention is differentially effective based on gender or perceived stress. The study will use the UWM Automated Community Health Information System, a relational electronic health record, to document the individualized ECNM intervention and dose of the intervention. The specific study aims are to: 1) examine differences between an ENCM treated group and a comparison group on self-efficacy, SM behaviors, and health status to establish effect sizes needed for a future large randomized controlled trial; 2) explore the dose-response of specific elements of the ENCM intervention; and 3) examine moderating effects of gender and perceived stress on the intervention effect. This is a two-group randomized experimental study with repeated measurements. Clients in the treatment group (n=25) will receive the individualized ENCM and those in the comparison group (n=25) will receive usual clinic care. Data will be collected at baseline, 1, 3, and 6 months to capture the immediate, short and longer term effects of the intervention. Acknowledging the small sample size, mixed models for repeated measures data (at baseline and M1, 3, and 6 post-intervention) will be fit to interactions involving moderating variables of gender and stress. The ENCM intervention draws on evidence that given the proper tools (i.e., knowledge, skills and support), individuals can learn to better self-manage their symptoms on a day to day basis and better utilize the health care resources available to them.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension diagnosis Attend Bread of Healing Clinic

Exclusion Criteria:

* No Hypertension diagnosis Do not Attend Bread of Healing Clinic
Dapansutrile in Diabetes and Diabetes-Related Complications - Dapan-Dia

The aim of the study is to determine whether NLRP3 inhibition with dapansutrile represents a new pharmacological option for diabetes management with potential as an anti-inflammatory agent to also address micro- and macro-vascular risk and complications from diabetes.

To date, no other oral NLRP3 inhibitor has sufficiently advanced in development to be tested in a chronic low-grade inflammatory disease such as type 2 diabetes mellitus over a period of 3 to 4 months as proposed in this trial. Based on the publicly available information, dapansutrile is the most advanced oral NLRP3 inhibitor in development. The rationale is built upon dapansutrile's clinical and extensive preclinical and safety findings, and from data in chronic animal toxicology studies to date, which together enable and support its investigation in select chronic low-grade inflammatory diseases. Therefore, the investigators have selected type 2 diabetes mellitus and its complications, including risk for cardiovascular disease, as a disease with clinical features of low-grade inflammation to further investigate the therapeutic potential of NLRP3 inhibition with dapansutrile.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2, Diabetes mellitus as defined by the criteria of the American Diabetes Association (ADA) Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (see Appendix 1) and recognized by the World Health Organization (WHO, 2019), for at least 3 months prior to the Baseline Visit/Day 1
* HbA1c value of ≥ 7.7% to ≤ 11.0% at the Screening Visit.
* High-sensitivity C-reactive protein (hsCRP) ≥ 1.5 mg/L at the Screening Visit.
* Body mass index (BMI) ≥18 to ≤ 40 kg/m2 at the Screening Visit
* Acceptable overall medical condition to safely participate in the study and complete all study procedures (particularly with regard to cardiovascular, renal, and hepatic conditions), in the opinion of the Investigator

Exclusion Criteria:

* Diagnosis of type 1 diabetes mellitus
* HbA1c value of ≤ 7.5% or ≥ 10.5% at the Baseline Visit/Day 1, as determined at point of care (local laboratory)
* Use of thiazolidinediones (glitazones), pramlintide, or short-acting insulin/insulin analogues (as bolus or premixed insulin) within 12 weeks prior to the Screening Visit
* Less than 80% compliance in taking investigational medicinal product by pill count during the Run-In Period, as assessed at the Baseline Visit/Day 1
* Significant weight loss (\> 5 kg) in the 12 weeks prior to the Screening Visit
* Systolic blood pressure (BP) ≥ 160 mmHg, diastolic BP ≥ 100 mmHg, or resting heart rate (HR) ≥ 100 beats/minute at the Screening Visit
* Previous myocardial infarction, any cardiac surgery
PK Study of Encapsulated Mesalamine Granules in Healthy Volunteers

The current study is being conducted to evaluate the relative bioavailability and single- and multiple-dose pharmacokinetics of encapsulated mesalamine granules(eMG) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* The subject is Male, or female of Non-childbearing potentia.l
* The subject is female of childbearing potential, who has a negative serum pregnancy test at screen and agrees to using appropriate birth control.
* The subject is between the ages of 18 and 45 years.
* The subject has a body mass index (BMI) between 18 and 32 kg/m2 (weight/\[height\]).

Exclusion Criteria:

* The subject is seropositive for human immunodeficiency virus (HIV),hepatitis B surface antigen, and/or hepatitis C virus.
* The subject has any clinically significant medical, social, or emotional problem.
* The subject is pregnant or lactating
* The subject has a history of clinically significant renal, hepatic,endocrine, oncological,gastrointestinal, or cardiovascular disease or a history of epilepsy, asthma, diabetes mellitus, psychosis, glaucoma, or severe head injury.
* The subject is currently receiving mesalamine or aspirin containing products
* The subject has a history of viral, bacterial, or fungal infection within 4 weeks of screening.
* The subject has an acute illness within 1 week of study-drug administration.
* The subject has an abnormal nutritional status, including unconventional, alternative,and abnormal diets; excessive or unusual vitamin intake; malabsorption; psychological eating disorders; difficulty swallowing medication; significant recent weight change; etc.
* The subject has clinically significant allergies.
* The subject has a hypersensitivity or allergy to mesalamine or other salicylate.
* The subject has known or suspected alcohol abuse or illicit drug use within the past year
* The subject has used tobacco (or nicotine products) during the 6 months prior to screening
* The subject has participated in an investigational drug study within the 30 days before receiving study drug
Nuclear Magnetic Spectroscopy Imaging to Evaluate Primary Lateral Sclerosis, Hereditary Spastic Paraplegia and Amyotrophic Lateral Sclerosis

This study will use a magnetic resonance imaging technique called nuclear magnetic spectroscopy (H-MRS) to define the pathology and progression of primary lateral sclerosis, hereditary spastic paraplegia and amyotrophic lateral sclerosis and assess the usefulness of this technique in evaluating patients' response to therapy. H-MRS will be used to examine metabolic changes in the parts of the brain and spinal cord (motor cortex and corticospinal tract) involved in movement.

Normal volunteers and patients with primary lateral sclerosis, hereditary spastic paraplegia or amyotrophic lateral sclerosis between 21 and 65 years of age may be eligible for this study. Participants will have up to five H-MRS studies, including baseline and follow-up tests. For this procedure, the subject lies on a stretcher that is moved into a strong magnetic field. Earplugs are worn to muffle the loud knocking noise that occurs during switching of radio frequencies. The subject will be asked to lie still during each scan, for 1 to 8 minutes at a time. Total scanning time varies from 20 minutes to 2 hours, with most examinations lasting between 45 and 90 minutes. Communication with the medical staff is possible at all times during the scan.

Standard MRI imaging of the brain shows no consistent abnormalities in many degenerative disorders with progressive upper motor neuron symptoms, including primary lateral sclerosis, hereditary spastic paraparesis, and amyotrophic lateral sclerosis. Nuclear magnetic resonance spectroscopy (H-MRS) is able to evaluate certain cerebral metabolites that reflect the functioning and integrity of neurons. The objective of this protocol is to study metabolic changes in the motor cortex and corticospinal tract using MRS in these disorders to characterize the pathology, the progression of the diseases, and assess the utility of MRS to follow the response to therapies.

Eligibility Criteria:
INCLUSION CRITERIA:

Adult patients with PLS, HSP, and ALS already evaluated by protocol #01-N-0148.

Adult normal volunteers

EXCLUSION CRITERIA:

Pregnancy, implanted devices such as pacemakers, medication pumps or defibrillators, metal in the cranium except the mouth, intracardiac lines, history of eye shrapnel injury or any other condition/device that may contraindicate or prevent the acquisition of an MRI.
The Diagnostic Ability of White Light Endoscopy and Magnifying Endoscopy With Optical Enhancement System

The purpose of this study is to valuation of the diagnostic ability of white light imaging and magnifying endoscopy with optical enhancement system in early gastric cancer and intraepithelial neoplasia.

Stomach cancer is the second most common cause of cancer death. Endoscopic identification and treatment of gastric intestinal metaplasia (GIM) and early gastric cancer (EGC) is essential to improve patients' 5-year survival rates. Conventional endoscopy with white light imaging (WLI) is widely used for endoscopic evaluation of EGCs. However, conventional endoscopic visualization of EGCs has a high rate of interobserver variability and correlates poorly with the histological findings. For this reason, diagnosis has been based mostly on repeated endoscopy with multiple biopsy samples. It has been reported that optical enhancement (OE) system is useful for discriminating cancerous lesions from non-cancerous lesions. The OE system is the newly developed image-enhanced endoscopic technology, which combines high definition white light endoscopy (WLE) and optical filters that limit the spectral characteristics of the illumination light. The optical filters can achieve higher overall transmittance by connecting the peaks of the hemoglobin absorption spectrum creating a continuous wavelength spectrum. Magnifying endoscopy is useful for observing the mucosal structures and microvessels. The VS theory proposed by Yao K is widely used in Magnifying endoscopy with optical enhancement system (ME-OE). Based on technical considerations, it is conceivable that ME-OE imaging techniques might have a distinct advantage over WLE in the diagnosis of endoscopic lesions. However, few reports have objectively proved that ME-OE is superior to WLE in the detection rate and diagnostic efficiency of EGCs.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years with H. pylori infection or histologically verified gastric lesions (chronic atrophic gastritis, intestinal metaplasia, GIN or EGC)
* Or patients aged 40-80 years from a region with high incidence of gastric cancer
* Or patients aged 40-80 years with first-degree relative of patients with gastric cancer
* Or patients aged 40-80 years with high-risk factors for gastric cancer (high salt or pickle diet or smoking or heavy drinking)

Exclusion Criteria:

* A history of gastrectomy
* Active gastrointestinal bleeding or advanced gastric carcinoma
* Coagulopathy or severe underlying diseases
* Pregnancy or lactation
* Absence of informed consent
Transversalis Fascia Plane vs Ilioinguinal and Iliohypogastric Nerve Block for the Treatment of CPIP

The aim of this study was to compare the efficacy of ultrasound (US)-guided transversalis fascia plane block (TFP) and ilioinguinal (II) and iliohypogastric (IH) nerve block in the treatment of chronic post-herniorrhaphy inguinal pain (CPIP) refractory to conservative treatments. For this evaluation, a numerical rating scale (NRS) will be used before and after both interventions.

Chronic post-herniorrhaphy inguinal pain (CPIP) after inguinal hernia surgery significantly affects quality of life and daily activities. The incidence of this condition ranges from 15% to 53% and its management is often challenging. CPIP is defined as pain lasting more than three months and can be diagnosed if no organic cause can be found to explain the pain at the end of this period. There are various methods in the treatment of CPIP, including medical therapy, nerve blocks and surgical intervention.

The inguinal region is mainly innervated by the ilioinguinal (II) and iliohypogastric (IH) nerves. These nerves are the most commonly damaged structures after inguinal hernia surgery.

However, the II and IH nerves can be easily blocked in isolation throughout their entire course in the groin area or in the abdominal wall at different injection sites using fascial plane blocks such as transversalis fascia plan block (TFP). These blocks are frequently preferred because of their ease of application and wide analgesic effects. Therefore, studies investigating the efficacy of fascial blocks that provide ease of application are increasing.

Although TFP and II-IH blocks have been used in the treatment of acute postoperative inguinal pain, they have been used in a limited number of studies for CPIP; however, no study has compared the efficacy and advers effect rates of these methods.

The primary aim of this study is to compare the efficacy of these two treatment modalities. The secondary aim is to determine the incidence of adverse events associated with US-guided TFP and II-IH nerve block therapy. A total of at least 80 patients will be enrolled for comparison, 40 patients in each group. The NRS score will be compared both within and between groups before, 1 month after and 3 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Complaints of inguinal pain \>12 weeks post-herniorrhaphy surgery
* \>18 years of age
* Failure of conservative pain management

Exclusion Criteria:

* Other causes of inguinal pain (haematoma, infection, tubo-ovarian disease, abscess, etc., gynaecological, urological and organic pathologies after inguinal hernia, etc.)
* Pregnancy
* Coagulopathy, antiaggregant/anticoagulant/antiplatelet use
* Unstable psychiatric illness
Exercise-induced Cardiac Adaptions in Rheumatoid Arthritis Patients During IL-6 vs. TNF Antibody Therapy

The present study will investigative the physiological effects of the cytokines interleukin-6 (IL-6) and tumor necrosis factor (TNF) on the adaptive changes to exercise in patients with rheumatoid arthritis. The investigators hypothesize that blockage of IL-6 receptors will decrease the cardiac and metabolic adaptations to exercise training compared to the inhibition of TNF. 80 patients will be included in a 12-week investigator blinded randomised exercise training intervention study.

80 patients with rheumatoid arthritis who are being treated with either interleukin-6 receptor blockers (IL-6Rb) or tumor necrosis factor inhibitors (TNFi) for a minimum of four months prior to enrollment will be recruited and undergo baseline testing, including examination, biochemistry, ECG, DXA, OGTT, pulmonary function, VO2max, echocardiography, cardiac MRI.

After baseline testing, 40 patients in IL-6 receptor blocker treatment and 40 patients in TNF inhibitor treatment.will be randomly allocated into one group receiving standard of care (control group) or a group performing supervised high-intensity interval training three times a week over a period of 12 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by sex by an independent person. Following the 12-week intervention period, all groups will complete a series of follow-up tests (as baseline testing).

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 and \<70 years
* Informed consent
* Diagnosed RA based on the 2010 American College of Rheumatology/ EULAR criteria. In biological treatment with either IL-6rB og TNFi over four months prior to enrollment
* Low RA disease activity, based on the Disease Activity Score-28 ESR for Rheumatoid Arthritis (DAS28) \<=3.2
* An electrocardiogram without features of left ventricular hypertrophy defined by the European Society of Cardiology
* Females of childbearing potential have to use one or more of the following highly effective methods for contraception in order to be included:

  * Vasectomized partner
  * Bilateral tubal occlusion
  * Sexual abstinence
  * Intrauterine device
  * Hormonal contraception
* Females who are considered to have no childbearing potential are

  * Bilateral tubal ligation
  * Bilateral oophorectomy
  * Complete hysterectomy
  * Postmenopausal defined as 12 months with no menses without an alternative medical cause

Exclusion Criteria:

* Health conditions that prevent participating in the exercise intervention determined by the Project Coordinator
* Subjects who cannot undergo MRI scans (metallic implants or claustrophobia)
* Corticosteroid use per os \> 10 mg/day within seven days of study enrollment
* Intramuscular corticosteroid within 3 weeks of the study enrollment
* Grade 2 hypertension (systolic BP \> 160 mmHg and/or diastolic BP \>100 mmHg) despite the use of antihypertensive drugs.
* Pregnancy
* Subjects with insulin dependent Diabetes
An Observational Study to Assess Safety and Effectiveness of Intravenous NovoRapid® in Hospitalised Subjects

This study is conducted in Asia. The aim of this observational study is to evaluate the side effects profile and benefits of using intravenous insulin aspart infusion in hospitalised subjects under normal clinical practice conditions in India.


Eligibility Criteria:
Inclusion Criteria:

* Any hospitalized subject with hyperglycaemia requiring intravenous insulin therapy is eligible for the study based on the discretion of the physician.

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude;
* Subjects with a hypersensitivity to NovoRapid or to any of the excipients.
* Subjects with conditions considered as contraindications.
Clinical Outcomes of the Endoscopic Resection of Premalignant and Malignant Gastrointestinal Lesions

To evaluate clinical outcome for patients receiving treatment of suspected premalignant and malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome is curative endoscopic resection. Secondary outcomes include resection technique utilized, rates of en bloc resection and adverse event rates, including infection, bleeding, perforation and death, and one-year survival rates.


Eligibility Criteria:
Inclusion Criteria:

* Patients age \>18 years that have been referred for endoscopic treatment of GI lesions.

Exclusion Criteria:

* Patients for whom endoscopic treatment was not performed.
Cervical Range of Motion and Stretching

Cervical range of motion (ROM) is necessary to perform normal activities of daily living and deficits are associate with various pathologies. Currently, its unclear if specific myofascial stretches will improve cervical range of motion and decrease myofascial sensitivity. After a single session of the manual stretching procedure, participants immediately demonstrated increased cervical ROM and pressure pain thresholds.

Methods: Sixty participants with no history of neck pain or trauma were randomized into one of two groups: stretching group (n = 30), or control group (n = 30). The stretching group received a standardized manual stretching protocol. The control group did not received intervention. Pre and Post-test measurements were recorded for both groups. Within group differences and group by time interactions were evaluated for Cervical range of motion ROM and myofascial sensitivity. The immediate improvement in active ROM of the cervical spine may prompt clinicians to consider the sequencing of treatment. Stretching prior to active exercises may allow for active exercise through a larger ROM. Future research is needed to evaluate the immediate effects of stretching in the symptomatic population.

Eligibility Criteria:
Inclusion Criteria:

* ages of 18-60
* active cervical flexion, right lateral flexion OR left cervical lateral flexion \<45˚

Exclusion Criteria:

* minors
* prisoners
* individuals with cognitive impairments
* recent neck surgeries
* pre-existing neck injuries