cyrilzakka/clinical-trials huggingface dataset:
Comparing Perclose to Statseal in Conjunction with Perclose in Femoral 6 French Arteriotomy Closure

The purpose of this clinical study is to compare how well two different devices for achieving hemostasis perform in patients undergoing transfemoral procedures with 6 French Access. Both devices are approved by the FDA for this use, and have already been used by clinicians on patients undergoing transfemoral procedures. It is believed that the use of both devices in combination compared to the Perclose alone will shorten the time that it takes to 'seal' the artery, resulting in a shorter period of time that patients would need to lay flat.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing diagnostic angiography or PCI with femoral access who undergo PercloseTM closure.
* Catheterization with a 6Fr system
* Those with a planned radial approach will also be enrolled given the possibility of changing to femoral access in the catheterization lab if radial access is not possible given radial artery spasm, significant patient discomfort with a contraindication to greater levels of sedation, inability to transverse guidewire into the aortic root, inability to engage coronary artery or deliver equipment, or other clinically indicated reason.

Exclusion Criteria:

- Candidates for this study will be excluded if any one of the following criteria is true:

* Use of a hemostasis method or device besides PercloseTM (Perclose may not be used in situations of heavy calcification, presence of dissection, etc).
* Patients undergoing catheterization only from the radial, brachial, ulnar, or distal radial (snuffbox) artery approach.
* Use of an anticoagulant other than unfractionated heparin or bivalirudin.
* Any use of glycoprotein inhibitors or cangrelor.
* Use of sheathless guides.
* Any anticipated need for continued anticoagulation post-catheterization, including extended bivalirudin infusion.
* Any active treatment with oral anticoagulants continued during course of procedure.
* Presence of arteriovenous dialysis fistula in the ipsilateral leg.
* Any physical deformity or trauma / injury of the leg that would prevent proper placement or function of the hemostasis band.
* Inability of the patient to personally consent for the study. (no surrogate consent)
* Cardiogenic shock, emergent procedures (high risk myocardial infarctions), or any clinical instability as assessed by the physician performing the procedure.
Corticalisation After Femoral Nail Dynamization in Hypertrophic Non-unions

In 12 patients with corticalization and hypertrophic pseudarthrosis were present after dynamization, the old nail was removed and nail exchange was performed with a longer and larger diameter nail to pass the region formed in the cortex approximately 2-3cm inferior from the old nail.

Corticalization is cortex-like sclerosis in the distal of the nail and it may indicate the early sign of dynamization treatment failure in hypertrophic nonunion after femoral transverse diaphyseal fractures. When corticalization is seen during follow-up after dynamization is performed because of non-union of a femoral transverse fracture, nail exchange should be performed without further delay. More rigid fixation should be applied with a longer and thicker nail crossing the area of corticalization.

Eligibility Criteria:
Inclusion Criteria:

* Subtrochanteric fractures
* Nonunion with Pain

Exclusion Criteria:

* Infection
* Pathological Fracture (Tumor)
Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)

The investigators aim to achieve experts consensus on respiratory interventions in management of COVID-19 related acute respiratory failure (C-ARF).

The investigators aim to achieve experts consensus on respiratory interventions in management of COVID-19 related acute respiratory failure (C-ARF). The pandemic of COVID-19 is unique in terms of a multitude of patients suffering from ARF and requiring invasive mechanical ventilation with single underlying inciting etiology.The experts have given divergent opinions on respiratory support of C-ARF which may have confused physicians globally.

The investigators are going to use a modified Delphi based methodology involving global participating experts. The objective is to achieve consensus statement on the management of C-ARF using "collective intelligence".

The whole process of this study will be done in the form of two-three rounds of Google Forms-based Delphi surveys. In this survey questionnaire, the investigators have prepared statements on the concern areas in the respiratory support of C-ARF. The survey has been divided into five sections related to C-ARF management. The majority of these statements are to be rated on Likert scale and others have multiple choices. There is an option for collecting participating experts comments in provided open space in round one which will be considered during round two questionnaire.

Eligibility Criteria:
Inclusion Criteria: (All the three criteria should be there) H index more than 10; one or more publication on respiratory failure in indexed journal; actively involved in management of COVID-19 related acute respiratory failure.

Exclusion Criteria:

Not meeting inclusion criteria
Does Cardiac Rehabilitation Reduce the Risk of Recurrence of Atrial Fibrillation Following the First Catheter Ablation?

Many risk factors contribute to the onset of atrial fibrillation. This study is specifically concerned with the effect of addressing these risk factors by cardiac rehabilitation on the risk of recurrence of atrial fibrillation following catheter ablation. A non-randomized, retrospective study was performed on patients treated with a catheter ablation for atrial fibrillation. The intervention group consisted of patients who chose to participate in the cardiac rehabilitation program. The control group only received standard care. The primary objective was to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation resulted in a reduction of the time to or the risk of recurrence of atrial fibrillation or the need for a second ablation within 1 year after the first ablation. A Kaplan-Meier analysis was used to examine the primary objective. The secondary objectives of this study were to examine whether cardiac rehabilitation following the first ablation for atrial fibrillation had an effect on the evolution of the patients' BMI (a Mann-Whitney U test), the number of recurrences of atrial fibrillation (a Poisson regression) and the proportion of patients who need to continue treatment with antiarrhythmics 3 months following the first ablation (a chi-square test).

The intervention group follows a 3 months rehab program consisting of training, education, coaching and medical follow-up. The control group are patients that chose not to follow this program. This is a retrospective non randomized trial

Eligibility Criteria:
Inclusion Criteria:

* an ablation for AF (Atrial fibrillation)

Exclusion Criteria:

* a complicated ablation
* a prosthetic heart valve
* a severe valvulopathy,
* hyperthyroidism at the time of the ablation,
* pregnancy and breastfeeding,
* intensive sport (more than 1 hour a day),
* a myocardial infarction or a thromboembolic event within 3 months after the ablation,
* a pacemaker
* end-stage renal disease.
A Study to Evaluate the Efficacy of Cytal® Burn Matrix in the Management of Partial-Thickness Burns to the Hand

This is a randomized controlled trial (RCT) aimed at determining if use of Cytal® Burn Matrix in the management of partial-thickness burns to the hand shows improved wound healing times when compared to EZ-Derm Porcine Xenograft.

A single site, two arm, parallel-design randomized trial comparing Cytal® Burn Matrix to EZ-Derm® Porcine Xenograft, for patients with partial-thickness burns to the hand. Up to 60 patients from a single center will be recruited and randomized (using a 1:1 randomization scheme) to receive either Cytal® Burn Matrix or EZ-Derm®. Scar formation, number of wounds requiring autografting, wound infections, rate of healing, hand function and impact of treatment will be compared between study arms. Additionally, a cost analysis and review of individual and group changes in narcotic prescription patterns and employment status will be evaluated. The protocol defined patient follow-up is 6 months.

An independent biostatistician will review all participant data for power and futility analysis. In addition, a clinical events committee will adjudicate adverse events (AEs) and serious adverse events (SAEs)

Eligibility Criteria:
Inclusion Criteria:

1. Male and Female, 18 to 75 years of age.
2. Negative pregnancy test required.
3. Presence of partial thickness burns to one or both hands.
4. Thermal burn etiology.

Exclusion Criteria:

1. Allergy or hypersensitivity to materials in porcine-based study products or personal preference.
2. Friction, chemical, or electric burn etiology.
3. Immunosuppression.
4. Presence of a local and/or systemic infection.
5. Received prior treatment to the study site within 60 days of Screening.
6. Concurrent participation in another clinical trial.
Safety and Efficacy of G17DT Immunogen Combined With Gemcitabine vs. Gemcitabine in the Treatment of Advanced Pancreatic Carcinoma

This study will test whether the G17DT Immunogen, when administered in combination with chemotherapy, is an effective and safe treatment for pancreatic cancer.


Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of pancreatic adenocarcinoma and unsuitable for pancreatic tumor resection
* Life expectancy of at least 3 months
* Functional status by Karnofsky Index of at least 70

Exclusion criteria:

* Prior treatment with chemotherapy, radiotherapy, or anti-cancer immunotherapy
* Chronic use of corticosteroids, except for inhaled corticosteroids used for asthma or chronic obstructive pulmonary disease
* Immunodeficiency
* Bone marrow transplant within past year
* Brain metastasis
Use of a Novel Weight Bearing Cone Beam Computed Tomography (CBCT) Scanner for Imaging of the Patellofemoral Joint

Healthy volunteers will have a weight bearing cone beam CT scan of their knee to assess normal alignment of the knee joint


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* Be 16 or more years of age
* Subject is able to be positioned properly in the investigational device and be still during the exam to reduce the potential of motion during the images

Exclusion Criteria:

* Have a history of patella instability
* Have had any type of previous knee surgery
* Have had a significant fracture of the patellofemoral joint
* Have a knee ligament injury
* Are pregnant at the time of screening or become pregnant during the study
* Have a history of high radiation exposure (i.e., undergone radiation therapy)
* Non-English speakers
Study of Lobaplatin，5-Fluorouracil and Leucovorin for the Treatment of Esophageal Carcinoma

The purpose of this study is to evaluate the efficacy and the toxicity of lobaplatin, 5-fluorouracil (5-FU) and leucovorin in patients with esophageal carcinoma.

patients with metastatic or recurrent esophageal cancer have a particularly poor prognosis .The overall 5-year survival rate for patients with newly diagnosed esophageal cancer is under 10%. Metastatic esophageal carcinoma is an incurable disease and due to the lack of effective therapies to manage this disease,the median survival is only 6 to 8 months Chemotherapy which is one of the most effective treatment so far is used as part of combined modality therapy for locally advanced diseases or as a palliative treatment for metastatic diseases.Lobaplatin is the third generation of platinum.Phase Ⅱclinical trials indicate that lobaplatin is effective for esophageal cancer, ovarian cancer, breast cancer and small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma of the esophagus(include cardiac cancer)
* Newly diagnosed patients should be unable or unwilling to surgery
* Recurrence after surgery must have no adjuvant chemotherapy or radiotherapy are allowed
* Patients are required to have dimensionally measurable disease,with an objective measurable focus:preferably the use of spiral computed tomography(CT)and measurements of maximum diameter≥1cm.
* Cooperative Oncology Group performance status 0-2 or KPS score ≥60,survival time ≥3 months
* Neutrophils(ANC)≥1.5×109/L; blood platelets counts(BPC)≥80×109/L
* Hemoglobin(Hgb)≥90g/L ,serum total bilirubin ≤1.0 times the upper normal limit(ULN): alanine aminotransferase and glutamic-oxalacetic transaminase (ALT and AST)≤2.5 ULN
* Serum creatinine (Cr)≤1.5ULN

Exclusion Criteria:

* pregnant or nursing women;
* Female patients at child-bearing age, without taking effective contraceptive methods;
* patients who have pathologic confirmation of other types of tumors (eg, leiomyosarcoma, malignant lymphoma) rather than esophageal cancer;
* patients with tumors other than esophageal cancer ,except cervical carcinoma in situ and skin basal cancer or squamous cell carcinoma received adequate treatment;
* patients with cerebral or meningeal metastasis, intestinal obstruction, or symptomatic pathologic changes of peripheral nerve,NCIC-CTG standard \>grade 2
* patients with serious complications such as: serious heart disease remained unstable after treatment, or myocardial infarction, congestive heart failure, unstable angina, frank pericardial effusion or unstable arrhythmias in 6 months before being enrolled into the group; confirmed neuropathy or psychosis, including dementia or epilepsia; uncontrolled infection;active disseminated intravascular coagulation;uncontrolled diabetes, fasting serum glucose\> 7.8mmol / L
Lifestyle Interventions for the Treatment of Early Onset Alzheimer's Disease Study

The purpose of this study is to generate preliminary data on the benefit of computerized cognitive training and Tai Chi- Qi Gong training in participants with Early-Onset Alzheimer's Disease. It is hypothesized that participants in the experimental training condition will perform better on outcomes related to cognition, functioning, and mood at follow-up compared to participants assigned to the active control condition.

This study aims to generate preliminary data regarding the efficacy of a combined cognitive-training and Tai Chi- Qi Gong exercise lifestyle intervention in participants diagnosed with Early-Onset Alzheimer's Disease (EOAD). Participants will complete a series of cognitive, functional, and mood assessments at a remotely-assessed baseline visit, and then be randomized into one of two conditions: (1) Computerized Cognitive Training + Tai Chi Exercise or (2) Active Control. Outcome measures will be repeated immediately Post-Treatment and at 6-months post-treatment Follow-Up. Specific Aim 1 will examine the feasibility of this lifestyle intervention and outcome assessments when applied to participants with EOAD. Specific Aim 2 will investigate if this lifestyle intervention improves short- and long-term cognition, functioning, and mood. Specific Aim 3 will be exploratory to assess whether individual differences in training or clinical/ demographic characteristics moderate the degree of benefit from this intervention; owing to sample size limitations in this feasibility study, focus of this latter aim will be on determining effect sizes and sample-size magnitude needed for future work.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the Longitudinal Early-Onset AD Study (LEADS) parent study, and being classified via LEADS consensus criteria as having amyloid-positive Early Onset Alzheimer's Disease
* Aged 40-64 years at the time of enrollment into LEADS
* Fluent in English
* In good general health and absent another neurological disorder
* Have a knowledgeable informant.
* Have had a Clinical Dementia Rating scale of 0.5 to 1.0 at the time of enrollment into LEADS
* Have sufficient vision, hearing, comprehension, and manual dexterity to participate in the testing and training program

Exclusion Criteria:

• Have access to the internet (e.g., home, family, public library, etc.) for less than 4 hours per week
Feasibility of Multi-gene Panel Testing at the Time of Diagnosis for Patients With Ovarian Cancer

The purpose of this study is to determine the feasibility of routine referral to genetic counseling for all patients with a new diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer.


Eligibility Criteria:
Inclusion Criteria:

* All subjects must have a new diagnosis of epithelial ovarian, primary peritoneal, fallopian tube or extra- uterine mullerian cancer.
* All subjects must have either undergone primary surgery or be planning neoadjuvant chemotherapy for the treatment of ovarian, primary peritoneal or fallopian tube cancer.
* All subjects must be able to comprehend and communicate in English.
* All subjects must agree to participate.
* A previous diagnosis of cancer is not an exclusion criterion.
* Previous genetic screening is not an exclusion criterion.

Exclusion Criteria:

* Patients who do not meet the above inclusion criteria.
* Patients with a diagnosis of a low malignant potential mullerian tumor.
* Patients who are not proficient in English language because the survey aspect of this study is comprised of 4 validated surveys that are only available in English language.
Treatment of Mood and Marriage Study (TOMMS)

The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.

Major depression has been associated with many individual and interpersonal problems in later life, including inadequate social support, marital distress, spousal depression, poor physical health, and higher rates of mortality. Marital therapy has shown promise as a treatment for depression and coexisting marital distress in younger cohorts, and there is a robust association between social support and depressive symptoms in older adults. The combination of couple therapy and antidepressant medication may provide an ideal treatment for older adults by targeting interpersonal and biochemical aspects of depression.

Couples interested in this study will complete an initial assessment with study personnel. In Phase I, eligible couples will receive weekly marital therapy and the depressed partner will receive medication management with a study doctor for 6 months. In Phase II, couples will be randomly assigned to either the combination treatment (marital therapy plus medication management) or medication management alone for 6 months. At the end of the treatment phase, a thorough assessment will be completed. A follow-up assessment will be completed 6 months after completion of treatment.

Eligibility Criteria:
Inclusion Criteria:

* One partner must receive a clinical diagnosis of major depressive disorder based upon our assessment
* Couples must be living together
* Either partner must report marital distress or tension
* Willing to take antidepressant medication and participate in weekly marital therapy and assessments
* The depressed partner cannot be involved in any other psychosocial treatment
* Score above 24 on the Mini Mental Status Exam

Exclusion Criteria:

* Both partners meet diagnostic criteria for major depressive disorder based on our evaluation
* Coexisting bipolar or psychotic disorder
* Evidence of a primary substance abuse or dependence disorder
* Current ECT treatment
* Evidence of active and severe domestic violence
Milk Volume Outcomes Following Oral Nicotinamide Riboside Supplementation in Mothers of Extremely Preterm Infants

Breastfeeding has well-established immunity and developmental benefits for newborns, yet mothers of preterm infants often struggle to provide sufficient breast milk. The investigators hypothesize that supplementing mothers of preterm infants with nicotinamide riboside (NR) during early postpartum will result in increased milk production. NR is a unique precursor to NAD+, which functions in whole-body metabolism, including that which supports the elevated energy demands of lactation. In lactating rats, NR supplementation improved milk quantity and quality, with metabolic benefits for the mother and lasting protective advantages for the offspring. No studies have been conducted to date that explore the short- or long-term use of NR for increasing milk supply in lactating women. This study will follow a small cohort of women and very preterm infants in the NICU throughout two intervention phases-- one in which each mother will randomly receive either NR or a placebo, then the opposite treatment-- to determine the effect of maternal NR supplementation on expressed milk volume and other markers of metabolism.


Eligibility Criteria:
Inclusion Criteria:

* informed consent for participation of both mother and baby
* infant delivered at ≤28 weeks gestation
* Infant born at the UC Davis Medical Center or transferred to the UC Davis Medical Center NICU within the first 6 days of life.
* Mothers willing to express and measure milk volume

Exclusion Criteria:

* Infant is participating in an intervention trial that could influence growth, development, or feeding tolerance
* Mother has previously undergone breast surgery or has experienced other breast trauma
* Mother is actively using narcotics or amphetamines
* Mothers is receiving cancer treatment
* Mothers is receiving lithium or gold therapies
* Mother plans to use any form of galactagogue (including fenugreek)
* Mother is taking any form of contraceptives or plans to resume use of contraceptive within four weeks of delivery
* Mother is involuntarily confined
* Mother is an adult unable to consent
* Mother resides \<50 miles from UC Davis Medical Center
* Anyone deemed unfit for participation by investigator(s)
Nitrate and Exercise-induced Cardiac Troponin T in Type 2 Diabetes

Blood cardiac troponin T (cTnT) concentration is a widely used marker of acute cardiac injury. Previous research has shown that type 2 diabetic patients may experience large increments in cTnT levels over the subsequent hours following a single bout of moderate-intensity endurance-type exercise. This phenomenon is likely attributed to cardiac ischemia-reperfusion injury caused by reduced nitric oxide (NO) bioavailability. Recent evidence indicates that ingestion of dietary nitrates dramatically increases the bioavailability of NO, and as such, may be protective against cardiac ischemia-reperfusion injury.

The investigators hypothesize that dietary nitrate supplementation blunts the rise in cTnT levels following exercise in type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* exercise-induced cTnT release (\>3ng/L)

Exclusion Criteria:

* HbA1c \<6.0% or \>10.0%
* morbid obesity (BMI\>35 kg/m2)
* incident cardiovascular events in the last year (heart attack, stroke
* use medication which contain nitrates and/or having vasodilatory effects