cyrilzakka/clinical-trials huggingface dataset:
DXA Precision and Accuracy Comparison Study

This study is being conducted to examine the performance of three common DXA machines (1) Lunar iDXA, (2) Lunar Prodigy and (3) Hologic Discovery A in measuring bone density and body fat.

For this study, two specific groups of volunteers will be recruited. In one group, the scan will measure bone density and in the other group the scan will measure fat. The groups will be broken into weight groups to determine which of the scanners the subject will be scanned on. Subjects will have the option to participate in either one or both groups.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women \> 20 years old
2. Willing to provide consent
3. Falls into one of three weight categories, with minimum 30 subjects per category.

   * Less than 200 lbs.
   * 200 (inclusive) to less than 350 lbs.
   * 350 (inclusive) to less than 450 lbs.
4. Participate in only one weight category in either skeletal or body composition cohort, or both.

Exclusion Criteria:

1. Inability to remain still for the duration of the DXA scans as judged by study Investigator.
2. Un-removable internal / external scan artifacts e.g. plaster casts, metal rodding naso-gastric tubes, etc.
3. Females of childbearing potential\* with actual (confirmed by positive urine pregnancy test) or suspected (based on study Investigator evaluation despite a negative urine test) pregnancy.
4. Subject had already given consent to participate in any aspect of this study.
Metformin Versus Standard of Care Treatment in Pregnant Women With Prediabetes

The purpose of this study is to assess if metformin reduces adverse outcomes associated with prediabetes in pregnancy. Our hypothesis is that pregnant women with prediabetes who are treated with metformin will show a greater reduction in large for gestational age infants at birth compared to women treated with the standard of care.

Women in pregnancy are routinely screened for diabetes in the first trimester and those who fall into the prediabetes category by hemoglobin A1c level of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation will be approached for consent in our randomized trial.

Once consent is obtained, the subjects will be randomized 1:1 into two parallel groups, the metformin treatment group and the standard of care treatment group (routine prenatal care). A random number generator will allocate the participants to the study groups.

Women taking metformin will continue twice daily dosing for the duration of their pregnancy after randomization. Those in the standard of care group will receive routine prenatal care. Both groups will undergo routine gestational diabetes testing by 28 weeks. Obstetric, maternal, and neonatal outcomes will then be assessed of both groups until the 6 week postpartum visit.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with hemoglobin A1c of 5.7 to 6.4%, fasting plasma glucose of greater than or equal to 100 to 125, or oral glucose tolerance test of greater than or equal to 140 to less than 200 before 14 weeks gestation
* Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
* Patients able to provide written informed consent

Exclusion Criteria:

* Pre-existing diabetes diagnosis as assessed at visit in the first trimester by history or by laboratory evaluation as listed above
* Presence of contra-indication to metformin (liver, renal, or heart failure) or sensitivity to metformin
* Participants who are under the age of 18
* Multiple Pregnancy
* Patients already taking metformin for other indications
* Fetal defect noted on early dating ultrasound
* Miscarriage before randomization
Study of XL647 in Subjects With Non-Small-Cell Lung Cancer

The purpose of this phase II study is to determine the safety, tolerability, and activity of XL647 in previously untreated subjects with non-small cell lung cancer (NSCLC). XL647 is a small molecule that potently inhibits multiple receptor kinases, including EGFR, VEGFR2 (KDR), ErbB2, and EphB4. Sensitivity to EGFR inhibitors has been linked to specific EGFR mutations and associated with certain clinical characteristics in patients with NSCLC (eg, female, minimal and remote smoking history, and adenocarcinoma histology).


Eligibility Criteria:
Inclusion Criteria:

* Subject has NSCLC with a histologically confirmed diagnosis of adenocarcinoma with measurable disease (stage IIIB, with malignant pleural effusion, and stage IV) and either has a demonstrated activating mutation of the EGF receptor in tumor tissue or meets one of three criteria: asian, female, and minimal or no smoking history.
* Measurable disease defined according to RECIST
* ECOG performance status of 0 or 1
* Normal organ and marrow function
* No other malignancies within 5 years, except for non-melanoma skin cancer

Exclusion Criteria:

* Radiation to ≥25% of bone marrow within 30 days of XL647 treatment
* Prior systemic anticancer therapy, including cytotoxic chemotherapy, anti-VEGF, anti-VEGFR, or anti-EGFR agents or investigational drug
* Subject has not recovered to ≤ grade 1 or to within 10% of baseline values from adverse events due to other medications administered \> 30 days before study enrollment
* Receiving anticoagulation therapy with warfarin (low-dose warfarin \< 1 mg/day, heparin and low molecular weight heparins are permitted)
* The subject meets any of the following cardiac criteria:

  * Corrected QT interval (QTc) of \> 460 msec
  * Family history of congenital long QT syndrome or unexplained sudden death
  * History of sustained ventricular arrhythmias
  * Has a finding of left bundle branch block
  * Has an obligate pacemaker
  * Has important bradycardia defined as a heart rate of \< 50 bpm due to sinus node dysfunction
  * Has uncontrolled hypertension
  * Has symptomatic congestive heart failure, unstable angina, or a myocardial infarction within the past 3 months
  * Has a serum potassium or serum magnesium level that falls outside the normal range
* The subject has progressive symptomatic or hemorrhagic brain or leptomeningeal metastases
* Uncontrolled intercurrent illness
* Subject is pregnant or breastfeeding
* Known HIV
Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy

Hypotheses:

Decompressive surgery of cervical myelopathy will improve bladder function.

Decompressive surgery of cervical myelopathy will improve sexual function.

The investigators will enroll consecutive cohort with cervical myelopathy who are scheduled to take surgical decompression of cervical spinal cord, aged between 25 and 65.

The exams for the patients include followings

* JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy
* VAS (Visual Analog Scale) pain score
* IPSS (International Prostate Symptom Score) and IIEF (International Index of Erectile Function) in male patients
* FSFI (Female Sexual Function Index) and UDI (Urinary Distress Inventory) in female patients
* Bladder compliance, Detrusor leak point pressure, Peak detrusor pressure
* Rigidity activity unit of penis

Eligibility Criteria:
Inclusion Criteria:

* evidence of progression of motor or sensory nerve
* cervical myelopathy in magnetic resonance imaging

Exclusion Criteria:

* radical pelvic surgery
* pelvic irradiation
* evidence of brain damage (dementia, cerebrovascular disease)
* evidence of psychotic disorder
Validation Study : FeetMe® Monitor Insoles for the Evaluation of Gait Speed

The aim of this study is to validate a smart insoles system in comparison to the gold-standard GaitRite in a healthy population. The device evaluate gait parameters in real time thanks to an embedded algorithm based on the processing of inertial measurement unit and 19 sensors signals.

At D0 and D7, the volunteer is evaluated by both the GaitRite® system and the FeetMe Monitor® system simultaneously. Healthy volunteers have two measurements 7 days apart. The volunteer repeats 5 trials at a comfortable speed on the GaitRite® mat while wearing the FeetMe® insoles. Each measurement is repeated by 4 different operators. A total of 20 trials are made by the volunteer.


Eligibility Criteria:
Inclusion Criteria:

* Have more than 18 years old
* Don't be pregnant or breast feeding

Exclusion Criteria:

* Be part of another study
* Not be able to give consent
* Not have access to social security
A 24-week Single-blind Trial of Prevention of Hand Eczema in Cleaners

This study aims to investigate the effectiveness of picture-based prevention education among professional hospital cleaners in relation to hand eczema. This is a single-blinded randomized clinical trial including hospital cleaners at three different hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Professional hospital cleaners ≥ 18 years old
* Sufficient Danish skills
* Written informed consent

Exclusion Criteria:

* Insufficient Danish skills
* Pregnancy
* Other skin diseases on the hands
* Receiving Immunomodulatory therapies
PART A: Efficacy and Safety of AEVI-001 in Children and Adolescents With ADHD and With mGluR Mutations

This is PART A of a 2-part, 6-week, double-blind, dose-optimization, parallel-group study in children and adolescents (ages 6-17 years) with ADHD with and without CNVs in specific genes implicated in glutamatergic signaling and neuronal activity. Parts A will include subjects determined to have a specific gene mutations implicated in glutamatergic signaling and neuronal connectivity.


Eligibility Criteria:
Inclusion Criteria:

1. Subject and parent/legally authorized representative (LAR) can speak English fluently and have provided written informed consent, and assent (as applicable) for this study.
2. Subject is 6 to 17 years of age (inclusive) at the time of consent/assent. The date of signature of the informed consent/assent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the Screening Visit (Visit 1).
3. Subject is male or non-pregnant, non-lactating female, who if of childbearing potential agrees to comply with any applicable contraceptive requirements prior to administration of investigational product (IP).
4. Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a primary diagnosis of ADHD based upon DSM 5 criteria.
5. Subject has a minimum score of ≥28 on the ADHD-RS-5 at the Baseline Visit (Visit 2).
6. Subject has been genotyped previously and has their identity confirmed (if required).

Exclusion Criteria:

1. Subject or parent/LAR is, in the opinion of the investigator, mentally or legally incapacitated, has significant emotional problems at the time of the Screening Visit (Visit 1) which could interfere with the conduct of study evaluations.
2. Subject has a current, controlled or uncontrolled, co-morbid major psychiatric diagnosis (aside from ADHD), including an anxiety disorder, major depression, bipolar disease, schizophrenia (or any psychotic disorder), and moderate or severe intellectual disability. Mild anxiety and/or depressive symptoms that do not meet diagnostic criteria for an anxiety disorder or major depression and/or do not require treatment are not exclusionary.
3. Subject has autism spectrum disorder to include a DSM-IV diagnosis of autistic disorder, Asperger's disorder, or pervasive developmental disorder.
4. Subject is currently taking any medication that might confound the results of safety assessments conducted in the study.
5. Subject has a known history of cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, cardiac conduction problems, exercise-related cardiac events including syncope and pre-syncope, or other serious cardiac problems.
6. Subject has any clinically significant abnormality on 12-lead ECG performed at the Screening Visit (Visit 1) and/or the Baseline Visit (Visit 2) such as serious arrhythmia, cardiac conduction problems, or other abnormalities deemed to be a potential safety issue.
Improving Supportive Care For Patients With Thoracic Malignancies

The purpose of this study is to use a proactive approach to improve symptom management of patients with thoracic malignancies and ensure receipt of evidence-based cancer care delivery. In this pilot study, the investigators propose to evaluate the feasibility of using outbound, proactive telephone symptom assessment strategies and ensuring evidence-based care receipt and measure the efficacy of this approach on patient satisfaction with their care, patient activation, quality of life and use of healthcare resources.

The investigators have previously shown in previous work that patients and caregivers who experience thoracic malignancies express poor symptom management that result in utilization of healthcare resources after-hours for symptoms that could have been prevented if assessed more proactively and prospectively. Currently, there are limited proactive approaches to prospectively identify and intervene on patient-reported symptoms. The purpose of this study is to enhance symptom assessment strategies by using a proactive assessment approach to improve symptom relief for patients with thoracic malignancies.

The investigators will test whether a proactive telephone symptom assessment and management strategy is feasible and can facilitate early patient report of their symptoms and intervention. The knowledge gained from this approach will be used to identify solutions that can be scaled nationally to improve patient-reported symptom management and patient satisfaction with their clinical care.

Eligibility Criteria:
Inclusion Criteria:

* All patients with lung cancer treated at VA Palo Alto. This includes all newly diagnosed patients and those under follow-up care.

Exclusion Criteria:

* Patients who do not anticipate receiving oncology care at the VA Palo Alto Health Care System.
* Patients who are unable to consent.
Trimester Sequential Estimation of Serum Zonulin as a Predictor of Gestational Diabetes Mellitus

Gestational diabetes mellitus (GDM) is the development of glucose intolerance (GI) during pregnancy in a previously normoglycemic (NG) woman and associated with insulin resistance (IR). GDM is the most prevalent metabolic disorder during pregnancy and became a major public health problem for being usually diagnosed and detected after 24 gestational weeks (GW), while its complications can occur much earlier and this may explain its burden on maternal and fetal welfare. Human zonulin is a surrogate marker of intestinal permeability and can be utilized as biomarker for intestinal barrier function. Zonulin-mediated increase in intestinal permeability plays a role in the pathogenesis of insulin resistance, obesity, DM and metabolic syndrome. The increasing global prevalence of GDM with its associated risk of poor pregnancy and long-term risks for the mother and the offspring may lead to the production of new generation of diabetics.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant Women with singleton fetus

Exclusion Criteria:

* Women with morbid obesity with body mass index ≥35 kg/m2;
* Had manifest DM, irrespective of being controlled or not;
* Bowel-related disorders;
* Autoimmune disorders;
* History of previous GDM.
Promoting Home Smoking Restrictions: Biomarker Feedback to Smoking and Non-Smoking Adults

This study is directed at decreasing home environmental tobacco smoking (ETS) exposure with a novel approach of adoption of home smoking restrictions. This will be done by providing the cohabitating smoker and non-smoker with biomarker feedback documenting exposure to ETS. The intent is to identify an intervention strategy(ies) to reduce ETS exposure.

This is a two-group interventional trial targeting cohabitating smokers and non-smokers. Participants will be randomized to the control condition or biomarker feedback group.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age
* Cohabitating Non-Smoker (control) and smoker (active)
* Smoker must test \> 6ppm on carbon dioxide (CO) test and non-smoker \< 6ppm
* General good health
* Written informed consent
* Live within Twin Cities 7 county metropolitan area (Minnesota)
* Plan to live in same home for 6 months and be willing for researchers to come to their home

Exclusion Criteria:

* Individuals that live in a treatment facility or shelter
* Individuals endorsing current domestic violence
Nurse Managed Upper Body Strength Training in Chronic Obstructive Pulmonary Disease (COPD)

This is a four month exercise training program for people with chronic obstructive pulmonary disease (COPD)with a 12 month follow-up.

People with moderate to severe chronic obstructive pulmonary disease (COPD) experience intense symptoms of dyspnea when they use their arms and shoulders. To control dyspnea they avoid using their arms and ultimately experience a significant loss of upper body (UB) strength and a decrease in the level of physical activity. Some pulmonary rehabilitation programs include strength training, but the training intensity is typically very low. The purpose of this research is to examine the effects of UB strength training (designed to maximize strength gains) with a self-confidence intervention to enhance adherence to exercise. This is an experimental study with random assignment of subjects to one experimental and two control groups: (a) UB strength training and self-efficacy intervention for adherence (experimental), (b) UB strength training with health education (control 1) and (c) gentle armchair fitness exercises with health education (control 2). Each subject will be studied for a total of 16 months.The intervention period is four months in duration with a 12-month follow-up period. The sample will be people with moderate to severe COPD who experience dyspnea with UB activities. This research is innovative in that it examines the effects of upper body strength training designed to maximize strength gains and combines it with a theory-based self-efficacy (confidence-building) intervention to promote adherence to training in people with COPD.

Eligibility Criteria:
Inclusion Criteria:

* FEV1/FVC \< 70 and FEV1 \< 80%
* \> or = 45 years of age
* Currently in stable clinical condition \[free of respiratory tract infections for at least two months prior to enrollment, no recent change in the color, consistency, or quantity of sputum, afebrile and no recent change in medical therapy\]
* Taking appropriate medications according to the GOLD standards
* Experience dyspnea with the use of their arms.

Exclusion Criteria:

* Evidence of restrictive lung disease or asthma
* Acute respiratory infection
* Taking oral corticosteroids on a regular basis
* \>3 exacerbations in the previous year
* Evidence of significant depression (Hospital Anxiety Depression Scale \>10)
* Presence of a potentially debilitating disease such as cancer, congestive heart failure, kidney disease, liver failure or cirrhosis, evidence of alcohol or drug abuse, diabetes requiring insulin therapy, musculoskeletal or degenerative nerve disease, etc.
* Presence of a condition that would make it potentially unsafe to exercise, including a history of a recent myocardial infarction, unstable angina pectoris, uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise, severe symptomatic aortic stenosis, uncontrolled symptomatic heart failure, uncontrolled metabolic disease, abnormal response to exercise test
* Currently participating in pulmonary rehabilitation.
Screening Protein Markers in Patients With Rheumatoid Arthritis and Hot-dampness and Blood Stasis Syndrome

The purpose of this study is to explore the protein markers and to applicate those protein markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with RA.

RA is one of the main disabling diseases in nowadays, which is an autoimmune disease with complex networks mechanism involving multiple signaling pathways and existing cross path. The investigators consider that the "heat-dampness and blood stasis" syndrome is the main syndrome and major pathogenesis for active RA, which on the base of the theory of traditional Chinese medicine and a large quantity of clinical practice, and also examined by mechanism experiments. But the material basis of this syndrome is remained unclear, lack of high specific objective basis to ensure the syndrome differentiation consistency accurately in clinical practice. Proteomic techniques study cells or the body by all the protein expression and function, thus has the potential efficient for decoding syndrome biological basis. Proteomic techniques are the most effective way to reveal the essence of TCM syndrome. The investigators will use proteomic technology to explore the protein markers and to applicate those protein markers in syndrome diagnosis of hot-dampness and blood stasis syndrome in patients with RA. With strong clinical applicability, this will reveal the scientific connotation of this syndrome, preliminarily guide the syndrome differentiation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects are made or confirmed diagnosis according to the American College of Rheumatology criterion and "heat-dampness and blood stasis" syndrome according to Traditional Chinese Medicine.

Exclusion Criteria:

1. Subjects have other serious diseases, such as liver and kidney disease, cerebral-cardio vascular diseases.
2. Subjects, who belong to "non-heat-dampness and blood stasis" syndrome, have double syndrome of heat or dampness.
MCW Master Predict (Profile Related Evidence Determining Individualized Cancer Therapy)

The study is an observational trial for patients undergoing cancer-related interventions and therapy at Medical College of Wisconsin Cancer Center. Projects under this protocol will use patient data that will be collected both retrospectively and prospectively. It will also enable prospective sample collection for specific cancer-related studies.

This is a master protocol that enables investigators to conduct observational research and correlative biospecimen studies. This study is non-therapeutic, with retrospective and prospective components. This will be a single-site study at MCW/FH. Retrospective data and, with consent, prospective observational data will be collected. The study will also include an opportunity for patients to consent to the analysis of specimens collected prospectively during care and for the collection of research-related testing of blood, stool, and/or urine. It is designed to decrease the burden on both patients and investigators by allowing consent to a protocol that will enable multiple minimal-risk studies.

Studies under this master protocol may perform data analysis using standard statistical techniques, as well as with advanced bioinformatics, machine learning, artificial intelligence, and other related technologies.

Collection and testing of biospecimens will only be performed if a proposed study that falls under this master protocol requires it. Studies may include a variety of simple or advanced techniques related to chemical, hematologic, molecular, proteomic, transcriptomic, immunomic, and metabolic analyses, as well as related multi-omic analysis for biomarker discovery, understanding correlations between treatment and molecular features, and/or for pharmacokinetic (PK) and pharmacodynamic (PD) parameters.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 years and older who were previously or are currently receiving care for a cancer-related condition at MCW/FH.