cyrilzakka/clinical-trials huggingface dataset:
National Mammography Database

The National Mammography Database (NMD) leverages data that radiology practices are already collecting under federal mandate by providing them with comparative information for national and regional benchmarking. Participants receive semi-annual feedback reports that include important benchmark data such as cancer detection rates, positive predictive value rates and recall rates. Participation in the NMD is free to Breast Imaging Center of Excellence (BICOE) facilities.


Eligibility Criteria:
Inclusion Criteria:

* All

Exclusion Criteria:

* None
Fish Oil, Metformin and Heart Health in PCOS

Women with Polycystic Ovary Syndrome (PCOS) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of Type II Diabetes and Cardiovascular Disease (CVD). This study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with PCOS, and those with PCOS and Type 2 Diabetes.

OBJECTIVES The objective in this proposed study is to determine the effect of dietary fish oil supplementation with metformin compared to standard of care metformin-alone treatment for 12 months on plasma lipids and apoB- remnant lipoprotein metabolism, and atherosclerotic cardiovascular disease and cardiac function in high-risk overweight-obese young individuals with PCOS.

This study will provide evidence-based research on the efficacy of fish oil, in the form as an adjunct therapy to standard treatment with metformin, as a safe nutritional treatment to add to therapeutic guidelines to reduce early CVD risk in young women with PCOS.

Specific Objectives;

1. To quantify carotid intimal medical thickness (cIMT) and plaque height before and after the intervention to assess the effect of fish oil supplementation combined with metformin standard of care on atherosclerotic cardiovascular disease and cardiac function.
2. To determine the effects of dietary fish oil supplementation combined with metformin and metformin standard of care on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations, and cardiac function variables including left ventricular (LV) posterior wall thickness, LV ejection fraction.
3. To assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PCOS
* overweight-obese (BMI \>25 kg/m2)
* elevated fasting plasma TG (\>150 mg/dL)
* and/or apoB48-remnant cholesterol lipoproteins (\>20 ug/ml)
* impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin \>15 (uM/ml), and may be diagnosed with T2D (blood glucose \>126 mg/dL).

Exclusion Criteria:

-pregnancy, lactation
Digital Connections: an EHealth Group Intervention for Young Adult Cancer Survivors

The purpose of this study is to determine the feasibility of recruiting young adult cancer survivors from across the nation and to explore the impact of an eHealth group intervention on psychosocial health in this population.

Study investigators will conduct a single-arm pilot trial in which a 10 week eHealth group intervention will be delivered via a study website. We will use a multi-pronged approach to recruit young adult cancer survivors from across the country. Study participants will attend weekly group meetings with a trained facilitator to receive the manualized intervention over the course of 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-39 years at the time of participation
2. Diagnosed with any invasive cancer between 15-39 years old
3. Finished curative cancer treatment 1 month to 5 years prior to enrollment (except maintenance therapy such as ongoing hormone therapy)
4. Currently experiencing at least mild symptoms of depression or anxiety (i.e., score ≥1 on the Patient Health Questionnaire-4)
5. Able to speak and read English so all group attendees can communicate in a shared language.
6. Able and willing to give informed consent.
7. Access to internet or cellular connectivity with sufficient bandwidth to participate in videoconferences

Exclusion Criteria:

1) Documented or observable psychiatric or neurological disorders that could interfere with study participation (e.g., psychosis, active substance abuse)
Mechanical Ventilation Weaning Protocol in the Coronary Care Unit

The following objectives were used for comparison: 1) primary objective: reintubation rate during hospitalization; 2) secondary objectives: length of hospitalization at the Coronary Care Unit; time from intubation to start of weaning; time from start of weaning to extubation; time from SBT and extubation; presence of respiratory infection in patients requiring reintubation; mortality of patients requiring reintubation.

Once the cause leading to the need of MV was resolved, patients from both groups underwent a daily clinical evaluation in the mornings, to determine whether they were ready for mechanical ventilation weaning, according to the following clinical SBT criteria: 1) Cause of MV: resolution of the cause and abnormalities leading to MV; 2) neurological stability: patient awake, without or with minimal infusion of sedatives/narcotics, with effective cough and Glasgow scale ≥ 9; 3) cardiovascular stability: mean blood pressure (MBP) ≥ 60 mm Hg, without vasopressors or with low vasopressor doses, heart rate (HR) ≤ 140 / min, hemoglobin (Hb) ≥ 8,0 - 10,0 g/L, partial arterial oxygen pressure (PaO2) ≥ 60 mm Hg with fraction of inhaled oxygen (FiO2) ≤ 0.4, oxygenation index (PaO2 / FiO2) ≥ 150 - 300 without significant respiratory acidosis; 4) metabolic stability: temperature \< 37.8° C (armpit) and lack of hydroelectrolytic disorders.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized at the CCU with MV for over 24 hours;
* age over 18 years;
* both genders;
* patients capable of spontaneous ventilation;
* patients with indication for MV weaning.

Exclusion Criteria:

* conditions and/or circumstances that might result in difficulty to understand the informed consent (psychiatric disorder, alcohol or drug addiction, mental disability);
* patient denies to sign the informed consent;
* end-stage diseases and
* dependence on mechanical ventilation.
Inspiratory Muscle Activation Pattern Analysis in Assisting Precision in Inspiratory Muscle Training in Patients With Chronic Respiratory Disease

Background \& Objective: Inspiratory muscle training (IMT) is known to improve strength and endurance of inspiratory muscles. However, clinical beneficial effects of IMT for patients with chronic respiratory disease remain inconclusive.

The purposes of the study are to investigate in patients with chronic respiratory disease: (Year 1) main (diaphragm) and accessory inspiratory muscle (sternocleidomastoid muscle) activation pattern during various IMT loading using group-based trajectory modeling (GBTM); and (Year 2) effectiveness of individualized IMT program (based on results of Year 1) on clinical outcomes. Methods: (Year 1) Patients with chronic respiratory disease with inspiratory muscle weakness will be recruited for the study. Patients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. Surface electromyography (EMG) of diaphragm and sternocleidomastoid muscle will be used to use inspiratory muscle activation during various conditions. Other outcomes include maximum inspiratory pressure, and functional exercise capacity will be measured. Inspiratory muscle activation will be used for GBTM analysis. Patient will then be trained with individualized IMT program based on the GBTM analysis input form results of Year 1.


Eligibility Criteria:
Inclusion Criteria:

* age \> 20 years old
* has been diagnosis of chronic obstructive pulmonary disease with stable clinical condition with no infection or acute exacerbation in the previous four weeks
* can cooperate with the measurements of this study

Exclusion Criteria:

* any clinical diagnosis that will influence the measurement, including any history of
* neuromyopathy
* angina, acute myocardial infarction in the previous one month
* pregnancy
* participated in inspiratory muscle training program in the previous three months
* any psychiatric or cognitive disorders, for example: Mini-Mental State Examination (MMSE) \< 24, that will disturb the communication and cooperation of the study
Efficacy of Ginsana in Improving Half-time Hemoglobin Re-oxygenation in Healthy Recreational Sports People

To assess the efficacy of Ginsana in improving hemoglobin re-oxygenation in healthy, recreational sports people and to assess the safety of the product.


Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers between 18 and 40 years old
* Females must test negative for pregnancy
* Recreational athletes according to the american college of sports medicine (ACSM) definition
* Familiar with the cycle ergometer exercise methodology
* Written inform consent according to good clinical practice (GCP) and local regulations

Exclusion Criteria:

* Pre treatment and/or concomitant treatment with any drug that any drug that may influence the trial symptomatology
* Alcohol and drug abuse as stated in the clinical trial manual
* Smokers
* Known hypertension
* Known hypercholesterolemia (moderate/severe)
* Female volunteers taking oral or injectable contraceptives
* Female volunteers of child bearing potential not using adequate means of birth control, other than contraceptive pills \[intrauterine devices (IUDs)\]
* Pregnancy and/or lactation
* Liver and/or renal and/or vascular disease
* Relevant allergy or known hypersensitivity to the investigational drug or its excipients
* Participation in another clinical trial within the last 4 weeks before the date of inclusion or concurrent participation in another clinical trial
Open-Label Study to Assess the Safety/Tolerability in Patients With Solid Tumors

To establish the maximum tolerated dose (MTD) of INCB007839 given as multiple doses for 28 days and to determine if a higher MTD can be established when INCB007839 is administered in combination with prophylactic anticoagulation and with a 2 and a half day (5 doses) treatment interruption every two weeks.


Eligibility Criteria:
Inclusion Criteria:

* Either non-small cell lung cancer, hormone-refractory prostate cancer, colorectal cancer, breast cancer, or squamous cell cancer of the head and neck that is refractory to standard treatment or for which no effective treatment exists. The patient must have a life expectancy of 12 weeks or longer.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Received any anticancer medications in the 28 days prior to receiving their first dose of study medication
* Evidence of venous thrombosis by flow Doppler examination at Screening
* A history of thrombosis or a coagulation disorder
* Patients with a contraindication to use of low dose warfarin and/or aspirin.
* Any unresolved toxicity greater than grade 2 from previous anticancer therapy, except for stable chronic toxicities not expected to resolve
* Brain metastases or spinal cord compression
* Impaired renal function
* Inadequate bone marrow reserve
Natural History of Hepatitis C in Patients With Normal Liver Tests

The Major goals of this project was to assess the natural history of disease in chronic hepatitis C patients with normal ALT and to determine the virologic and host factors associated with disease severity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic hepatitis C and persistently normal liver enzymes
* able to give consent

Exclusion Criteria:

* decompensated liver disease
* any prior antiviral or immunosuppressive therapy
* other liver disease besides hepatitis C
Effects Of High Intensity Interval Training On Speed And Explosive Strength In Sprinters

High Intensity Interval Training (HIIT) is a type of exercise that alternates between short bursts of high and low intensity activity. The physical components may be improved very effectively and efficiently with this kind of training. The choice of an effective practice strategy could be very beneficial because boosting an athlete's performance is correlated with improving their physical components. The significance of this study was that HIIT is helpful in increasing strength, endurance and agility. Thus it could be useful for athletes for their physical fitness in less duration as compared to the conventional protocols.

According to researchers knowledge there is lack of sufficient literature on "The Effect Of High Interval Intensity Training On Speed And Explosive Strength In Sprinters." The past trials do not address speed and strength in relation to HIIT and this study will help identify the need to practice this training in order to enhance the skills and athletic performance of sprinters and will uplift their anaerobic fitness.

Eligibility Criteria:
Inclusion Criteria:

* Age ranging from 18 to 30 years
* Actively competing in races
* Had professional sprinting experience of one year
* Both genders included.
* Athletes who have clean bill of health for past 6 months
* Never engaged in a high intensity training program

Exclusion Criteria:

* Any Neuromuscular issue like myopathy, peripheral neuropathy and multiple sclerosis
* Any Musculoskeletal issue like chronic low back pain, tendinopathies, disc slips and OA
* Pregnancy
* Athlete who is on any kind of medications
Elastic Abdominal Binder Following Gynecologic Cancer Surgery

Surgery is the primary treatment for gynecologic malignancies. The surgical approach provides opportunities for removal of the affected organs and complete assessment of extent of cancer spread. However, the procedures are often associated with significant morbidity. This is especially true with open laparotomy, the most frequently employed approach in developing countries. Delayed functional recovery influenced by pain and immobilization are important contributing factors for increased morbidity. Elastic abdominal binder, a wide elastic belt that is wore around the patient's abdomen to support surgical incision after surgery, has been employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder use in this patient population have not been properly examined.

The aim of this study is to examine the effect of postoperative elastic abdominal binder use on recovery by comparing pain scores and mobility function (through the 6-minute walk test \[6MWT\]) in postoperative gynecologic cancer patients who use versus do not use the elastic abdominal binder to support incisional site.


Eligibility Criteria:
Inclusion Criteria:

* Women, diagnosed with gynecologic malignancies (carcinoma of the cervix, endometrium, and ovary), undergoing open abdominal surgery

Exclusion Criteria:

* Intraoperative accidental injury to urinary or gastrointestinal organs
* Postoperative admission to intensive care unit (ICU)
* Postoperative intraperitoneal drain placement
* Unable to understand and follow oral/written instructions
* Severe neuromuscular or circulatory disorders
RadioEmbolization for the ADvancement of Y90 Glass Microspheres Registry

This study is a non-interventional, observational, prospective, and global participant data registry. The study will collect effectiveness and safety data from approximately 1000 participants with liver cancers treated with TheraSphere® in a real-life setting from multiple centers globally. The absorbed dose to tumor and normal tissue will be calculated using the Simplicit90Y™ software in the subgroup of hepatocellular carcinoma (HCC) participants.

This study is a non-interventional, observational, prospective and global participant data registry.

Approximately 1000 participants with liver cancers who are treated with TheraSphere® will be enrolled.

Data regarding participant and treatment characteristics (TheraSphere® and other anti-cancer treatments) will be collected within a 12-month period post TheraSphere® administration to:

* Assess treatment effectiveness and safety in a real-life administration setting
* Identify prognostic and predictive factors for liver cancer participants receiving TheraSphere® treatment

Data for dosimetry determination will be collected on approximately 300 HCC participants to assess:

* Technetium-99m Macroaggregated albumin (99mTc-MAA) normal tissue and tumor Absorbed Dose using pre-procedural Single Proton Emission Computed Tomography/ Computed Tomography (SPECT/CT)
* Yttrium-90 and isotopes (Y90) normal tissue and tumor Absorbed Dose using post-procedural PET/CT (or equivalent for Asia) scans

Eligibility Criteria:
Inclusion Criteria:

1. Participant is ≥ 18 years of age
2. Participant has confirmed liver cancer
3. Participant is able to provide informed consent according to local requirements/law
4. Participant has a life expectancy of ≥ 3 months
5. Participant is scheduled to receive TheraSphere® treatment

Exclusion Criteria:

1. Participant who has previously received Y90 microspheres
2. Participant who has consented to participate in a BTG-sponsored clinical study that includes TheraSphere® treatment
A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer

The purpose of this clinical trial is to determine whether the combination of 5-fluorouracil (5-FU) plus a DAVANAT (carbohydrate polymer) along with Avastin and Leucovorin (LV) is beneficial in treating colorectal cancer in patients unable to tolerate intensive chemotherapy.

This is a Phase II, multi-center study of DAVANAT which has been shown to increase the anti-tumor activity of 5-FU in mice. 5-FU is a chemotherapy drug commonly used to treat tumors. A Phase I study of 40 patients showed that DAVANAT in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage III and IV), not amenable to curative surgery or radiotherapy.
* Intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the Investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan,
* Presence of at least 1 measurable lesion,
* Have a life expectancy of at least 4 months.
* Women of childbearing potential, have a negative serum pregnancy test at screening and Day 1 treatment and agree to practice abstinence or use an effective method of contraception.

Exclusion Criteria:

* Central nervous system metastasis.
* Bony metastasis as the sole metastasis.
* Received any prior first-line chemotherapy for colorectal cancer.
* Previously exposed to DAVANAT® or Avastin®.
* Known or clinically suspected infection with HIV.
* Participated within 30 days or will participate concurrently in another investigational drug or vaccine study.
* History of drug or alcohol dependence in the past 3 years.
* Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the Investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.
Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects

This trial is conducted in Europe. The aim of this clinical trial is to compare the metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18.5 and 30 kg/m2
* Good general health based on assessment of medical history, physical examination, ECG (electrocardiogram), and clinical laboratory data at screening, as judged by the physician
* Non-smokers

Exclusion Criteria:

* Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the physician
* Blood transfusion within 3 months of trial start
* Positive for hepatitis B or C infection
* Positive for Human Immunodeficiency Virus (HIV) infection
* Excessive consumption of a diet deviating from a normal diet as judged by the physician
* Blood or plasma donation within the last 3 months prior to trial start
* Subjects with any history of migraine
Communication Bridge 3 Study

This study will use a randomized controlled trial design to evaluate the effect of two evidence-based treatments for adults with mild-moderate Primary Progressive Aphasia (PPA). The aim of the study is to help us better understand the effects of speech-language therapy on communication abilities in individuals with PPA.

Participants with a diagnosis of PPA and their actively-engaged care partners will be involved in the study for approximately 17 months. Each participant will receive a laptop equipped with the necessary applications and features for the study. Participants will receive up to 10 evaluations and 20 speech therapy sessions with a licensed speech therapist, as well as access to Communication Bridge, a personalized web application to practice home exercises that reinforce treatment strategies. There are no costs to participate in this study.

Eligibility Criteria:
Inclusion Criteria (person with PPA):

1. Meets diagnostic criteria for PPA based on neurologist and supporting medical assessments (extracted from medical records)
2. English as primary language used in daily communication activities (by self-report)
3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
4. Adequate vision (aided or unaided) for reading a newspaper, or other functional materials (by self-report)
5. Able to pass technology screening and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)
6. Geriatric Depression Scale score ≤ 9
7. Mild-moderate PPA informed by a structured interview with a speech-language pathologist and a standardized testing battery.

Inclusion Criteria (Co-enrolled communication partner):

1. 18+ years of age
2. English as primary language used in daily communication activities (by self-report)
3. Adequate hearing (aided or unaided) for communicating with others in a crowded room (by self-report)
4. Able to pass technology screening\* and demonstrates sufficient knowledge for use of video conference and Communication Bridge™ web application use (with or without training)

Exclusion Criteria:

* A dementia diagnosis other than Primary Progressive Aphasia
* Participation is co-enrolled in an outside speech language therapy program during the study course.
* Communication partners will be excluded if they have a pre-existing communication impairment that would affect study participation (e.g., aphasia, dementia)

Medical records will be requested and reviewed to determine eligibility