cyrilzakka/clinical-trials huggingface dataset:
Comparison of Self Adjustment Versus Standard of Care Treatment in Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA). This trial aims for a comparison of the safety and efficacy in subjects with type 2 diabetes using either self titration or physician guided titration according to the local standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes HbA1C \<= 12.0% within the past 12 months;
* BMI \<= 45.0 kg/m2
* Initiation, addition of, change to, or continuation of basal insulin therapy with insulin detemir as deemed necessary by Investigator

Exclusion Criteria:

* Anticipated change in concomitant medication known to interfere with glucose metabolism such as systemic steroids, non-selective beta-blockers or mono amine oxidase (MAO) inhibitors.
* Proliferative retinopathy or maculopathy that has required acute treatment within the last 6 months.
* Any glucose lowering medication that is not indicated in combination with insulin, such as GLP-1 Analogues
* Known hypoglycemia unawareness or recurrent major hypoglycemia, as judged by the Investigator
Multi-Parametric MRI Assessment of the Liver in Diabetic Volunteers (Partners Registry)

To build a registry of diabetic volunteers by inviting them to get a LiverMultiScan and collecting their contact information to seek interest in participating in future research studies.

Perspectum's LiverMultiScan is a quantitative multiparametric MRI method, FDA-cleared and CE-marked, that is used to detect and stage early liver disease.It is already widely used internally in both research and within the clinical setting. LiverMultiScan has been adopted as the only liver scan in whole-population long term studies. The LiverMultiScan is more cost efficient, short in duration(\<15mins), non-invasive and safe(no IV or oral contrast required, no ionizing radiation and no venipuncture).

This is a registry where there will be no intervention to the standard of care. Registry volunteers will be required to attend a single visit that will involve having a multi-parametric MRI at no cost to them. In addition, the investigators will collect contact information of the volunteers including their email address, phone number and home address so that they can be contacted to discuss possible participation in future studies which may be sponsored by Perspectum or third parties, such as pharmaceutical companies.The volunteer's personal information shall never be shared with these third parties. Additionally, the contact information of the volunteers' medical providers shall also be collected so that the LiverMultiScan reports can be delivered to them.

Eligibility Criteria:
Inclusion Criteria:

* Male or female diabetic volunteers aged 18 years and over who are willing and able to give informed consent for participation in the registry.

Exclusion Criteria:

* The volunteer may not enter the registry if they have any contraindication to magnetic resonance imaging (standard MR exclusion criteria at the imaging center including pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia).
Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions

This is a bioequivalence study of nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited under fasting conditions

Open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, comparative oral bioavailability study in healthy, adult, male human subjects under fasting conditions.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 18 and 55 years of age (inclusive) living in and around Ahmedabad city of western part of India.
* Having a Body Mass Index (BMI) ≥ 18.0 kg/m2 (calculated as weight in kg/ height in m2).
* Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
* Able to communicate effectively with study personnel. Able to give consent for participation in the trial

Exclusion Criteria:

* Known hypersensitivity or idiosyncratic reaction to nizatidine or other related drugs.
* Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
* Ingestion of a medication at any time in 14 days before the start of the study. In any such case subject selection will be at the discretion of the Principal Investigator/Medical expert/co-investigator.
* Any history or presence of asthma or nasal polyp.
* A recent history of alcoholism (\<2years) or of moderate (180 ml/day) alcohol use.
* Smokers, who smoke more than 10 cigarettes/day or those who cannot refrain from smoking during study period.
* The presence of clinically significant abnormal laboratory values during screening.
* Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scan.
* History of psychiatric disorders.
* A history of difficulty with donating blood.
* Donations of blood (1 unit or 450 ml) within 90 days prior to receiving the first dose of study medication. Note: Incase the blood loss is ≤ 200 L, subject may be dosed after completion of 60 days of blood donation).
* A positive hepatitis screen including hepatitis B surface antigen, anti-HCV and anti-HAV antibodies.
* A positive test result for HIV antibody and/or syphilis.
* The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study medication (Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study). (Note: If subject had participated in a study in which blood loss is ≤200 mL, subject can be dosed after completion of 60 days of previous study).
* An unusual diet, for whatever reason (eg., low-sodium), for four weeks prior to receiving the study medication and throughout the subjects, participation in the study. In any such case subject will be at the discretion of the Principal Investigator/Medical expert/Co-investigator.
Evaluate The Effectiveness Of Fospropofol (Lusedra®) For Induction Of Anesthesia

Interstitial cystitis is a condition where a defect in the protective lining of the bladder causes the urinary symptoms such as urgency, frequency and pain/burning on urination. One way to help ease the symptoms of this disease is to fill the bladder full of water every 4 to 6 months.

Since this is a painful procedure an anesthesiologist will give you a drug that will make you unconscious for the procedure. General anesthesia can be given to you through an IV tube that is placed in a vein in your arm. There are only a few agents that induce sedation and these agents have certain disadvantages such as waking up slowly, low blood pressure, and pain at the injection site and a prolonged time to consciousness.

This study will be comparing doses of a new IV sedation induction agent drug to put you to sleep called fospropofol (Lusedra®).


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients

  -\> 18-65 years of age,
* weight 60-90 kg,
* with an American Society of Anesthesiologists (ASA) physical status of P1 to P3 are eligible for enrollment.
* Female patients of child bearing age will have a negative urine pregnancy test result and have used an acceptable method of birth control for \>1 month prior to study enrollment.
* Patients will be NPO \>6 hours and scheduled for outpatient urological hydrodilation under general anesthesia.
* Patients also will not be enrolled in another study or have received an experimental drug in the prior 30 days.

Exclusion criteria are:

* hypersensitivity or allergy to any anesthesia, opioids, benzodiazepines or any drugs used in the study, failure to meet NPO status or an abnormal, clinically significant ECG finding.
* Another exclusion is the presence of a difficult airway that would prevent use of the laryngeal mask airway (LMA) or successful LMA insertion.
* Women who are breast feeding would also be excluded from participation.
The Effects of Open Chain Versus Closed Chain Strengthening on Dynamic Valgus During a Step Down Test

The goal of this clinical trial is to compare the effects of different exercises programs in individuals with abnormal knee motion. The main question it aims to answer are:

* In individuals with abnormal knee motion and without knee pain, does a weight-bearing exercise program reduce abnormal knee motion during a step-down test better than a non weight-bearing exercise program? Participants will
* Perform a stepdown test while undergoing motion analysis and electromyograph (EMG) recording.
* Participants will then be placed either into a weight-bearing or non weight-bearing exercise group. Exercises will be performed 3 times per week for 6 weeks.
* Further motion analysis and EMG data will be collected to test for differences. Researchers will compare individual results before and after exercise, and between-group results before and after exercise to see if one exercise program helps improved abnormal knee motion more than the other.

The goals of this trial is to compare the effects of a closed kinetic chain exercise program to an open kinetic chain exercise program in individuals without knee pain who also have dynamic knee valgus during a step-down test.

Individuals will be screened for participation via visual observation. Those with an observable medial collapse of the knee joint will then receive motion capture testing of the step down test (three trials) with electromyography recording of the gluteus medius, quadriceps and hamstring muscle groups. Baseline maximum voluntary contraction of these muscles will be done with EMG analysis and force gauge measurements.

After initial data collection participants will be randomized into either a closed kinetic chain exercise group or open kinetic chain exercise group. (described in the Arms section) Participants will exercise 2-3 times per week for 6 weeks. After the exercise program is completed, participants will then be seen back for final data collection which will match the initial collection process.

Eligibility Criteria:
Inclusion Criteria:

* Dynamic knee valgus with observed step down test

Exclusion Criteria:

* Presently experiencing lower extremity pain
* Lower extremity surgery within the past 1 year
The Effect of Upper Limbs Motion During Single-leg Jump Landing After Anterior Cruciate Ligament Reconstruction

The aim of this study is to investigate the effect of upper limbs motion on lower limb biomechanics and muscle activity during single-leg jump landing after anterior cruciate ligament reconstruction.

More and more people join in different sports in recent years. But the incidence of sports injury also increases. And the most frequently occurring and debilitating knee injury in sports is rupture of the anterior cruciate ligament (ACL). Patients who aim to return to their preinjury sports should undergo anterior cruciate ligament reconstruction (ACLR) in order to maximize knee stability. The overall incidence rate of a second ACL injury within 24 months after ACLR was nearly 6 times greater than that in healthy participants. Although many studies have showed about biomechanical and neuromuscular risk factors during jump landing which were thought to associate with the secondary injury after ACLR, these studies all focused on the motion of lower extremity. But actually, people often use their upper limbs to catch or throw a ball during jump landing in playground. Whether the upper limbs motion will affect the muscle coordination of lower extremity during jump landing is still unknown. Therefore, the purpose of our study is to investigate the effect of upper limbs motion during single-leg jump landing after ACLR.

Eligibility Criteria:
Inclusion Criteria:

* Only one leg has operation of ACL reconstruction
* At least 1 year after ACLR or have been back to sports
* Exercise in sports regularly.

Exclusion Criteria:

* Other operation of lower extremity exclude ACLR
* Any diseases or poor condition that will affect jumping or deterioration after jumping.
The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan

Chronic obstructive pulmonary disease (COPD) has substantial economic and human costs. To minimize these costs high quality guidelines have been developed. However, development of guidelines alone rarely results in changes to practice. One method of integrating guidelines into professional practice is the use of clinical pathways (CPWs).

The investigators are working with local stakeholders to develop CPWs for COPD with the aims of improving quality of care and guideline adherence while reducing healthcare utilization. The CPWs will utilize several steps including: standardizing diagnostic training, implementing and unifying common components of chronic disease care, coordinating the provision of education and reconditioning programs, and ensuring disease specific care utilizes and delivers evidence-informed practices. In addition, the investigators have worked to identify evidence-informed strategies for the implementation of the CPWs. Efforts are underway to tailor these implementation strategies for the local context.

The investigators will conduct a three-year quantitative health services research project using an interrupted time series (ITS) design in the form of a multiple baseline approach with control groups. The CPW will be implemented in two Saskatchewan health regions (experimental groups) and two health regions will act as controls (control groups). The experimental and control groups will each contain one urban and one rural health region.

This project is expected to improve quality of life and reduce healthcare utilization. The project will also provide evidence on the effects of CPWs in both urban and rural settings. If the pathways are found effective the investigators will work with all stakeholders to implement similar CPWs for the remaining health regions in the province.


Eligibility Criteria:
Inclusion Criteria:

* All individuals with diagnosed chronic obstructive pulmonary disease (COPD)

Exclusion Criteria:

* N/A
A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement

The prevalence of hypertension among U.S. adults increased from 32% to 46% and African Americans are disproportionately impacted. Self-managing hypertension presents challenges such as dealing with complex treatment regimen, including critical components of recommended hypertension treatment such as self-blood pressure monitoring, and lifestyle modifications involving diet, exercise, and tobacco cessation. African Americans with hypertension have lower adherence to self-management behavior due to multifactorial reasons. Substantial evidence has demonstrated the important role of community support in improving patients' self-management of a variety of chronic illnesses, though integrating technology in such programs are rarely offered.

The purpose of this study is to investigate the effectiveness of a community outreach program using a technology-based intervention (TBI) to support self-managing hypertension (called COACHMAN) to improve BP control.

COACHMAN targets barriers to hypertension knowledge, medication adherence, problem solving skills, patient-provider communication, and social support in an effort to improve blood pressure control.

The investigators will conduct a two-arm randomized control trial (RCT) using a community participatory research approach and mixed methods to evaluate the efficacy of TBI intervention with community support (Coachman) compared to enhance usual care (ECU) among 60 African Americans with uncontrolled hypertension.

The investigators aim to:

1. Identify key content, design, and resources from a community of stakeholders, including determining facilitators and barriers of hypertension self-management among African Americans that will inform the development of COACHMAN using a mixed methods approach methods.
2. Evaluate the feasibility and acceptability of COACHMAN to improve BP control.
3. Compare the difference in BP control between Technology-based intervention (TBI) and Enhanced usual care (EUC).

Eligibility Criteria:
Inclusion Criteria:

* self-identifying as African American
* age 30 years or older
* diagnosed with hypertension, with a blood pressure \>140/80 mmHg
* prescribed at least one antihypertensive medication
* able to read and understand English
* own a smartphone

Exclusion Criteria:

* history of cognitive impairment
* currently using a medication management app
Efficacy of the "Living With Type 1 Diabetes to Grown-Up" Interactive Podcast Program

The present study aims to evaluate the intervention effectiveness of the Online Interactive Podcast Program"Living with Type 1 Diabetes to Grown-Up"in patients with type 1 diabetes transitioning from adolescence to early adulthood.

Individuals aged 16-25 with Type 1 Diabetes (T1D) face significant transitional challenges in their lives, with an increased risk of worsening disease management. Addressing these challenges, an interactive podcast program,

\&amp;#34;Living with Type 1 Diabetes to Grown-Up\&amp;#34;; is being developed with a one-year grant from the National Science and Technology Council. This continued project will span three years, employing a mixed-method research design for evaluation. Participants will be recruited from pediatric endocrinology and genetics clinics and wards across two medical centers in Northern Taiwan. In line with recommendations from prior reviewers, the study will incorporate a two-phased approach: the first phase is a quantitative study, structured around transitional theory and self-regulation theory using PRIDE steps. It adopts a double-blinded, randomized controlled experimental method with data collector and sham treatment participants blinded. Subjects will be randomly assigned to either the experimental group (N=44) or the active control group (N=44). Comparative analyses will focus on variations in disease control, emotional disturbance, confidence in self-management, self-care behaviors, diabetes knowledge, interpersonal disturbance, and family conflict at baseline, and post-interventions of immediate, 3-month, and 6-month periods. In the subsequent qualitative phase, 15-20 cases from the experimental group will be selected for in-depth interviews to evaluate the impact of the \&amp;#34; Living with Type 1 Diabetes to GrownUp \&amp;#34; interactive podcast program.

The outcomes of this research are anticipated to contribute significantly to the clinical management and technological intervention strategies for T1D adolescents in their transitional phase to adulthood.

Eligibility Criteria:
Inclusion Criteria:

* a confirmed diagnosis of T1D by an endocrinologist before the age of 16 and a disease duration of \>6months
* patients aged 16-25 years
* mean HbA1C level ≥7.5% one year before inclusion
* ability to communicate in Chinese or Mandarin
* patients who own smartphones with internet access
* patients who agreed to voice recording during a session explaining the treatment process
* patients who signed the informed consent form prior to participation; for minors, a legal representative must provide consent and sign the informed consent form.

Exclusion Criteria:

# T1D patients with other concomitant metabolic diseases, chromosomal aberrations, major illnesses, and cognitive impairment will be excluded from this study.
Does Preconditioning Affects Other Organs in Patients Undergoing Open Heart Surgery ?

An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and inflammatory process is well known . Ischemic preconditioning reduces the inflammation

Preliminary evidence has suggested the role of inflammation in development and prognosis of cardiovascular diseases and cancers. Most of the prognostic studies failed to account for the effects of co-morbid conditions as these might have raised the systemic inflammation. We used neutrophil lymphocyte ratio (NLR) as a measure of systemic inflammation and investigated its association with cardiac preconditioning in open heart surgery .

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* American Society of Anesthesiologists physical status II and III
* Patients scheduled for open heart surgery
* no active inflammatory process

Exclusion Criteria:Exclusion Criteria:

* Emergency surgery
* Clinically significant kidney or liver disease
* Patients allergic to local anesthetic
* Patients with prolonged cardiopulmonary bypass time (\>120 min)
* Patients required intra-aortic balloon pump
* Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration
MTA/FS Pulpotomy for Vital Primary Incisors: A Randomized Controlled Trial

To compare radiographic and clinical outcomes and survival of mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy and root canal therapy (RCT) in carious vital primary maxillary incisors.

Dental caries is the most common chronic disease in children. Caries of the primary maxillary incisors is common in young children; often necessitating either extraction or pulp therapy. The premature loss of primary maxillary incisors can adversely affect a child's dental occlusion, ability to properly size food boluses for swallowing, speech articulation, facial esthetics and psychosocial development. Pulp treatment of cariously exposed vital primary incisors may prevent premature tooth loss as well as eliminate pain. Currently, there is a paucity of outcome investigations with regard to pulp therapy in primary incisors.

Eligibility Criteria:
Inclusion Criteria:

* children with one or more carious primary maxillary incisors where removal of dental caries will likely to produce a vital pulp exposure
* reside in the GTA at time of inclusion
* English-speaking

Exclusion Criteria:

* history of spontaneous or lingering stimulated pain, swelling, fistula or sinus tract, tenderness to percussion and pathological mobility
* incisors with preoperative radiographic evidence of periapical or periradicular radiolucency, a widened periodontal ligament space, physiological resorption, incomplete root formation, internal or external root resorption, pulp canal obliteration or pulp calcifications
* non-restorable tooth