cyrilzakka/clinical-trials huggingface dataset:
A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone

The purpose of this clinical research study is to learn if BMS-512148 (Dapagliflozin) can help reduce the blood sugar levels in Asian patients with Type 2 Diabetes who are not well controlled on metformin alone. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control
* Drug naive or treated with anti-diabetic medication for \< 24 weeks
* C-peptide ≥ 1.0 ng/mL
* Body Mass Index ≤ 45.0 kg/m²

Exclusion Criteria:

* AST and/or ALT \> 3 times ULN
* Serum total bilirubin \> 2 mg/dL
* Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
* Creatine kinase ≥ 3 times ULN
* Symptoms of severely uncontrolled diabetes
* Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Sentus QP - Extended CRT Evaluation With Quadripolar Left Ventricular Leads

The QP ExCELs study is designed to confirm safety and efficacy of the BIOTRONIK Sentus OTW QP left ventricular leads to satisfy FDA requirements for regulatory approval of the leads in the US. The Sentus OTW QP leads received FDA approval on May 4, 2017.

Long-term safety of the BIOTRONIK Sentus OTW QP left ventricular leads will be confirmed during the ongoing post approval phase (US sites only).

A protocol update was implemented on September 6, 2019 to transition the long-term follow up for the ongoing Sentus QP Study to a new EP PASSION real-world data methodology.


Eligibility Criteria:
Inclusion Criteria:

* Standard CRT-D indication according to clinical routine
* De novo implantation or upgrade from existing ICD or pacemaker implant utilizing a BIOTRONIK CRT-D system with IS4 LV port and Sentus QP LV lead
* Patient is able to understand the nature of the clinical investigation and provide written informed consent
* Patient is able and willing to complete all routine study visits at the investigational site through 5 years of follow-up
* Patient accepts Home Monitoring® concept
* Age ≥ 18 years

Exclusion Criteria:

* Chronic atrial fibrillation
* Contraindication to CRT-D therapy
* Currently implanted with an endocardial or epicardial left ventricular lead or had prior attempt to place a left ventricular lead
* Cardiac surgical procedure, such as coronary artery bypass graft or valve surgery that is planned to occur within 6 months after implant or ablation that is planned to occur within 90 days after implant (ablations planned to occur prior to or at implant are not exclusionary)
* Expected to receive a heart transplant or ventricular assist device within 6 months
* Life expectancy less than 12 months
* Participation in any other investigational cardiac clinical investigation during the course of the study
* Presence of another life-threatening, underlying illness separate from their cardiac disorder
* Pregnant or breast-feeding at time of enrollment
Medications for Stopping Cocaine Dependence and Preventing Relapse

Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to identify subpopulations and baseline conditions that are most responsive to treatment for cocaine dependent individuals.

Cocaine is a strong central nervous system stimulant that is widely abused throughout the United Sates. Due to its widespread use, it is important to develop an effective treatment for cocaine dependence. Motivational Interviewing (MI) is often effective when combined with drug treatment. Baseline condition (e.g., abstinence status) and population type (e.g., ethnicity and gender) often affect how an individual responds to treatment for drug dependence. The purpose of this study is to determine the influence of baseline status and population type on treatment response in cocaine dependent individuals. In addition, this study will examine how various cocaine abuse medications target different neuronal systems, withdrawal symptoms, and relapse to drug use.

This study will take place in two phases. Phase I will last 4 weeks; participants will receive MI and undergo contingency-based urine tests in order to achieve the desired baseline condition. Phase II will last 12 weeks. Participants in Phase II will be randomly assigned to receive one of four treatments: 1) 50 mg naltrexone, 2) 800/200 mg levodopa/carbidopa, 3) 400 mg modafinil, or 4) placebo. During Phase II, all participants will receive psychotherapy and contingency management. Participants will complete urine drug screening tests 3 times each week. Follow-up study visits will occur between 3 and 6 months following Week 12, and will include objective and self-reported drug use.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for current cocaine dependence

Exclusion Criteria:

* Meet diagnostic criteria for other serious psychiatric symptoms and/or disorders that would interfere with participation in the treatment study (e.g., psychosis; mania; suicidal/ homicidal ideation) including other forms of drug dependence, nicotine and cannabis excepted.
* Medical conditions contraindicating naltrexone therapy (e.g., past history of opioid use in the 30 days prior to study entry or significant hepatocellular injury)
* Medical conditions contraindicating modafinil therapy (e.g., hypertension, seizures, arrhythmia, or coronary artery disease)
* Medical conditions contraindicating levodopa/carbidopa therapy (e.g., severe pulmonary/cardiovascular disease, narrow angle glaucoma, melanoma, history of peptic ulcer, or renal function impairment)
* Requires certain medications
* Current or recent treatment for substance use or other psychiatric condition
* On parole or probation that requires reports of drug use to officers of the court
* Pending incarceration
* Pregnant or breastfeeding
* Unable to read, write, or speak English
* Plans to leave the study area within 3 months of study entry
The Effect on the Older's Cognition of Dual-loop Target Controlled Infusion Guided by Narcotrend Index

To investigate the effect on older's cognition of the application of closed target-controlled infusion(TCI) of propofol and remifentanil guided by Narcotrend index .

Two hundreds of patients scheduled for surgery under general anesthesia were randomly divided into two groups:closed-loop (group A,n=100) and open-loop group(group B,n=100).The procedure during induction of anesthesia was same in two groups.In group A,if Narcotrend index(NI) fall down to 46 and keep more than 30 seconds,propofol and remifentanil were intravenously infused as feedback automatically to achieve the target NI of 26-46.However,the NI in group B was controlled manually.Taking an exam of MMSE before and after the surgery which measures if the older's cognition changed. Furthermore.we will measure the levels of protein S100beta and NSE.

Eligibility Criteria:
Inclusion Criteria:

1. ASA Ⅰ \~ Ⅱ women undergoing Laparoscopic surgery.
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18.0～25 kg/m2

Exclusion Criteria:

1. Mental illness can not match
2. epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. Chronic renal failure
5. Alcohol or drug abuse
6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression dru
Application of a Novel Biomarker Based on Plasma cfDNA Assay in the Early Diagnosis of Prostate Cancer

The goal of this diagnostic test is to obtain multiple cell-free DNA （cfDNA） fragment profiles of subjects by whole genome sequencing based on plasma cfDNA, build a prostate cancer prediction model by machine learning, and to validate the efficacy of this model in patients who need to undergo needle prostate biopsy base on their prostate-specific antigen（PSA） or clinical or imaging evidence. Therefore, this study aims to explore the efficacy of this prostate cancer prediction model in distinguishing between patients with PSA "gray zone" (4-10 ng/ml) in the diagnosis of prostate cancer and patients with clinically significant prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Male, 18-80 years old;
2. PSA: 4-10ng/ml;
3. Patients scheduled for prostate biopsy：

   * fPSA（free PSA）/PSA \< 0.16 or PSAD（PSA density） \> 0.15 (ng/mL/cm³) or PSAV（PSA velocity） \> 0.75 (ng/mL/year) ② positive DRE （digital rectal examination） ③suspicious positive lesions on ultrasound/MRI).

Exclusion Criteria:

1. Patients with a prior diagnosis of any malignancy within 5 years;
2. Patients who have undergone prior transurethral resection or enucleation of the prostate;
3. Patients who have received prior treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, and immunotherapy;
4. Patients with long-term use of anticoagulant and antiplatelet aggregation drugs (anticoagulant discontinued for less than 1 week);
5. Received any form of oncological treatment, including surgery, radiotherapy/chemotherapy, endocrine therapy, targeted therapy, and immunotherapy prior to enrollment for blood sampling;
6. concurrently suffering from other serious systemic diseases that, in the opinion of the investigator, may interfere with the treatment, evaluation and compliance of this trial, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immune, urinary and other systemic diseases;
7. Organ transplant recipients or prior non-autologous (allogeneic) bone marrow or stem cell transplant population;
8. Subjects who have had a blood transfusion 1 month prior to the blood draw;
9. Patients who are participating in other clinical trials, or who have participated in other clinical trials that have been completed less than 1 year ago;
10. Patients who, in the judgment of the investigator, are not suitable for participation in this clinical trial;
11. Patients who meet any of the above criteria may not be included as subjects.
Efficacy of Intermittent Fasting on Metabolic Disease

To elucidate the health effects, and further explore the research on safety. This study was conducted among adults with metabolic disease by using the intermittent fasting for 4 weeks. The aim of this study is to provide scientific basis for the IF used as a new prevention and control technology for metabolic disease.

In this trail, participants with metabolic disease were enrolled for 4-week intermittent fasting intervention. The intermittent fasting plains include time-restricted fasting and 5:2 project. For TRF regimen, participants are allowed to eat ad libitum from 7am to 5pm and fast in other time. For 5:2 project, chose two non-consecutive days per week to eat very little and eat ad libitum the other 5 days of the week. Serum samples and feces samples were collected before and after intervention for analysis.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged between 18 to 75 years old with metabolic disease

Exclusion Criteria:

* diet therapy before participation
* pregnancy
* severe hepatic diseases
* severe nephropathy
* organic digestive diseases
* autoimmune diseases
* cancer
* infectious diseases, including pulmonary tuberculosis and AIDS
* alcoholism
* continuous antibiotic use for over 3 days within 3 months prior to enrollment
* continuous use of a weight-loss drug for over 1 month
* gastrointestinal surgery
The Effect of Cold Storage Solutions on Ischemic Injury in Lung Transplantation

The purpose of this study is to compare 2 different cold storage solutions, used to preserve donor lungs for lung transplantation, and their effect on cytokine activation related to ischemic reperfusion injury. Primary endpoint is 30 day survival.

The length of ischemic time in harvesting lung allografts is associated with graft survival. It is further thought that ischemic changes in early post-transplantation bronchoscopic biopsies has a direct correlation with later development of chronic rejection.

Eligibility Criteria:
Inclusion Criteria:

Any patient undergoing a lung trasnplant at Johns Hopkins Hospital -

Exclusion Criteria:

-
Cognitive Control and Metacognition Training

95 autistic children (ages 8-11yrs) will be randomly assigned to a novel computer-based Cognitive Control Training combined with Metacognition Coaching or to a comparison group that receives the intervention after a delay. Before and after intervention, electroencephalography (EEG) will be used to examine engagement of the target neural responses.

Effective interventions to reduce the functional impact of core features of autism spectrum disorder (ASD) in school-aged children are critically needed. This study will test whether in-person computer training delivered individually by a coach engages an electroencephalographic (EEG) biomarker of cognitive control (N2 event-related potential \[ERP\] amplitude). Developing more effective cognitive control, metacognition, and working memory is predicted to enhance neural responses to conflicting information (i.e., a neural marker of effective cognitive control). The study will randomly assign 95 autistic children (ages 8-11yrs) to a novel computer-based Cognitive Control Training combined with Metacognition Coaching or to a waitlist control group. Before and after intervention, EEG will be used to examine engagement of the target neural responses. We expect the group assigned to Cognitive Control Training + Metacognition Coaching to exhibit significantly larger changes in N2 ERP amplitude in incongruent relative to congruent trials than the waitlist group. Before and after intervention, we will collect neural responses and behavioral measures of cognitive control and working memory.

Eligibility Criteria:
Inclusion Criteria:

* Children should be 8 to 11 years of age
* Children should have an existing diagnosis of an autism spectrum disorder, which will be confirmed using research measures and criteria
* Children must have general cognitive ability in the average range or above (above 80 using the Wechsler Abbreviated Scale of Intelligence-2 Full Scale IQ)
* Caregivers and children must be fluent in English or Spanish

Exclusion Criteria:

* Children must not have a known genetic condition related to autism (e.g., Fragile X)
* Children must not have medical conditions/injuries, exposure to substances, or significant deprivation with implications for the central nervous system or that require regular psychoactive medications that alter EEG responses (anticonvulsants, barbiturates) \*
* Children must not have seizures or a seizure disorder (other than history of febrile seizures)
* Children must not have significant sensory or motor impairment or major physical abnormalities that would limit the ability to participate in table top or EEG testing, or make responding during computer activities difficult
* Children must not have a failed screening for colorblindness
Postprandial Effects of Functional Bread

This study investigates whether bread with added galactomannan, a soluble fiber, can reduce the postprandial glucose response in healthy overweight adults.

This single-blind crossover-designed study wants to investigate the postprandial effect of functional bread in healthy overweight adults. Therefore, four types of bread, consumed by the participants, have added galactomannan in different amounts and viscosities, and one bread is the control bread.

The participants arrive after an overnight fast and before the consumption of bread, a fasting blood sample is taken.

After the ingestion, blood samples are taken at specific times. The area under the curve of the postprandial glucose is expected to differ between the functional breads.

Eligibility Criteria:
Inclusion Criteria:

* healthy, overweight adults (BMI between 25 and 30 kg/m2)

Exclusion Criteria:

* Known diagnosis of diabetes mellitus type 2
* HbA1c at screening ≥ 48 mmol/mol
* Other chronic diseases (heart disease, cancer) within the last 3 years
* Pregnancy and lactation
* Known drug or alcohol abuse
* Unwilling to follow the study requirements
Acetabular Bone Vascularity in Metal-on-Metal Revisions

The purpose of this study is to determine if avascular necrosis of the acetabulum is present in metal-on-metal revisions and to what depth this dead avascular bone occurs.

A convenient sample of a consecutive series of 15 patients treated for metal on metal acetabular revision surgery will be included.

Patients being treated for metal on metal acetabular revision surgery by a physician at OrthoCarolina, PA will be screened for eligibility. These patients will be approached by their surgeon and asked to volunteer their participation in the study. Potential subjects will meet with a research coordinator to discuss details of the study and those you volunteer participation will be asked to sign an informed consent prior to the collection of study data. . Basic demographic information (initials, age, gender, height, weight, BMI), dates of original index surgery, reason for revision, type of implant being removed, and standard of care cobalt and chromium metal ion levels will be collected via chart review.

Patients who meet all eligibility criteria will have three biopsies performed at the time of their revision surgery. A pathologist will note the presence or absence of bone necrosis and will measure the length (mm) of necrosis, acute inflammation, chronic inflammation, normal bone, and entire bone specimen in order to obtain a ratio.

Biopsy Protocol:

A bone biopsy is a procedure in which bone samples are removed (with a special instrument during surgery) and looked at under a microscope for necrosis (tissue death), infection, or other bone disorders. Once the acetabular hip replacement implants have been removed the following steps will occur:

* The biopsy needle will be inserted into the bone (3 locations; 2 from ilium, 1 from pubis or ischium = 3 total).
* The biopsy needle will be withdrawn and firm pressure will be applied to the biopsy site for a few minutes, until the bleeding has stopped.
* Each bone biopsy sample will be labeled sequentially and by anatomic location (i.e., ilium #1, ilium #2)
* The normal bone will be marked on the bone sample.
* The bone biopsy sample will be sent to the lab for examination.
* The acetabulum bone will be reamed so the new implant can be seated.

Eligibility Criteria:
Inclusion Criteria:

* Patients being revised for an aseptic metal on metal acetabular revision.
* Patient is greater than one year postoperative.
* Patient has had cobalt and chromium metal ion levels tested within 6 months of the planned revision surgery.
* Understands the local language and is willing and able to follow the requirements of the protocol.
* Understands the informed consent and signs the institutional review board or independent ethics committee (IRB/IEC) approved informed consent form.

Exclusion Criteria:

* History of infection
* Evidence of current substance or alcohol abuse
* Being treated with radiation, chemotherapy, immunosupression, or chronic steroid therapy (prednisone use up to 5 mg/qd or its equivalent is allowed)
* Is a prisoner
Effects of Comprehensive Fall Prevention Protocol (CARE: Cognitive-Aerobic-Resistance-Exer-gaming) on Mobility Level in Elderly

Lack of research oriented health care facilities especially rehabilitation department in Pakistan. 30-50 % of population of age 65 years and above have some problems with balance (3) and 75 % of people aging 70 years and above have poor balance which leads to fall related injuries (5). So fall and related injuries are major problem in this age group. All studies conducted so far addresses only one or two aspects of balance training not to all. This study will address all the aspects and develop a comprehensive balance training protocol and will try to contribute to this under research area.

Lack of research oriented health care facilities especially rehabilitation department in Pakistan. 30-50 % of population of age 65 years and above have some problems with balance (3) and 75 % of people aging 70 years and above have poor balance which leads to fall related injuries (5). So fall and related injuries are major problem in this age group. All studies conducted so far addresses only one or two aspects of balance training not to all. This study will address all the aspects and develop a comprehensive balance training protocol and will try to contribute to this under research area.

Cost effective treatment for patients. To meet the expectation of patient to improve their quality of life and improvement of their satisfactory level. It will be interesting for patient to visualize the activity patient is performing and comparison of effectiveness of comprehensive fall prevention protocol with traditional balance training.

It will reduce the occurrence of fall episodes and hence reduce the cost to treat these fall and fall related injuries. Older adult will be less dependent, and more mobile and contributing member of the community.

Objectives

The objectives of the study are:

1. To compare the effect of comprehensive fall prevention protocol (CARE) on fall risk as compared to conventional training in elderly.
2. To compare the effect of comprehensive fall prevention protocol (CARE) on Mobility Level as compared to conventional training in elderly.
3. To compare the effect of comprehensive fall prevention protocol (CARE) on Wii Fit balance as compared to conventional training in elderly.
4. To compare the effect of comprehensive fall prevention protocol (CARE) on Dynamic Balance as compared to conventional training in elderly.
5. To compare the effect of comprehensive fall prevention protocol (CARE) on Quality of life as compared to conventional training in elderly.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of age 60 -80 years
* Either gender
* Berg balance score between 20-40

Exclusion Criteria:

* • Musculoskeletal conditions (fractures, severe arthritis)

  * Neurological conditions like Epilepsy, Parkinson,
  * Alzheimer's, Impaired cognition
  * Other systemic diseases or co-morbidities
Establishing the Effectiveness of Publicly Available Smoking Cessation Resource

The purpose of this study is to evaluate the effectiveness of SmokefreeTXT, a smoking cessation text messaging program currently available to anyone in the United States through www.smokefree.gov, and to compare cessation outcomes for smokers living in different regions of Virginia while participants use the program. Participants will be asked to complete assessments at Baseline, 7 weeks, 3 months, and 6 months and will be asked to use a research version of SmokefreeTXT.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 and over
* Current cigarette smoker (has smoked at least 100 cigarettes in their lifetime and currently smokes)
* Ability to read and speak English
* Resident of Virginia
* Owns a cell phone

Exclusion Criteria:

* Not a current smoker (e.g., started a quit attempt between providing interest information and starting the study)
* Identity not able to be verified from information provided on interest form
* Does not own a cell phone
* Pregnant smoker or may become pregnant in the next 6 months
* Lives in an area that has met recruitment criteria (after recruitment has begun)