cyrilzakka/clinical-trials huggingface dataset:
The California WISEWOMAN Project:Cardiovascular(CVD) Health for Hispanic Women

The purpose of this trial is to provide low-income, under- or un-insured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

This study is based on a single group. Evaluated how effectively culturally appropriate lifestyle intervention was in improving, over a relatively short-term period (\~12 months) on health behaviors and the CVD risk profile.

Eligibility Criteria:
Inclusion Criteria:

* National Breast and Cervical Cancer Early Detection Program (NBCCEDP)participants without cancer
* Income \< 200 percent of federal poverty level
* Under or uninsured for the health care coverage
* Blood pressure \>= 120 mm Hg systolic or \>=80 mm Hg diastolic or currently taking medication to lower cholesterol

Exclusion Criteria:

* \>180 mm Hg systolic or \>110 mm Hg diastolic
* \> 400 cholesterol
* pregnant women
* had past or current CVD events
Evaluation of Feasibility of Radial Access for Primary Angioplasty and to Assess it in High Risk Subgroups

Primary percutaneous coronary intervention is the preferred treatment for patients with ST-segment acute coronary syndrome. The radial access is an established approach, associated with a reduction in vascular access related complications after primary percutaneous coronary interventions. The purpose of this study is to examine the baseline characteristics, risk factors, procedural parameters and complications in patients with STEMI taken for primary angioplasty by radial access.

Data of all patients with acute STEMI with primary PCI through radial access is to be evaluated for baseline characteristics and procedural parameters and complications. Patients in the prospective study are followed up till discharge and any in-hospital complication noted.

This was a prospective, observational and descriptive study. Three hundred fifteen consecutive patients with an ST-segment elevation acute myocardial infarction (STEMI) treated with primary angioplasty by radial access, admitted between March 2016 and Feb 2017 were analyzed for their baseline characteristics, risk factors, and procedural parameters, complications and outcomes. High risk sub-groups analysis was also done. High risk groups includes patients with age \>75yrs, cardiogenic shock, severe LV systolic dysfunction, acute left ventricular failure, high degree AV block, right ventricular infarction and low BMI. The study is conducted among patients with acute STEMI, considered for primary PCI through radial artery access at operator discretion.

This study analyzed the baseline characteristics of patients which includes clinical history, clinical examination, ECG, 2D ECHO, coronary angiogram to evaluate cardiovascular risk factors.


Eligibility Criteria:
Inclusion Criteria:

* All patients presenting with STEMI and being considered for primary PCI through radial access between March 2016 and Feb 2017.

Exclusion Criteria:

* Patients with ACS other than STEMI
* All primary PCI in STEMI through femoral access.
* All radial elective PCI.
A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization

The multi-centric, open label, single arm and self controlled study is planned to assess the efficacy of orally administered Sigmart in subjects with recurrent angina after coronary revascularization. The primary objective of this study is to demonstrate that orally administered Sigmart can improve the major Exercise Tolerance Test (ETT) result in recurrent angina subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects should be 18\~70 years old, male or female
* Subjects should have a history of coronary revascularization at least 6 months ago
* Subjects should present with typical angina or similar to the chest pain before prior coronary revascularization for at least 1 month
* Subjects should be relieved from anginal attacks with short-acting NTG
* Subjects should have the ability to withhold medication which cannot be concomitant in this clinical study during the study
* Subjects should have an ability to give written informed consent

Exclusion Criteria:

* Unstable angina
* Left main coronary artery disease
* Aortic stenosis
* Obstructive hypertrophic cardiomyopathy
* Subjects with hypertension (SBP\>170 mmHg or DBP\>100 mmHg) or hypotension (SBP\<90 mmHg or DBP\<60 mmHg)
* Postural hypotension (drop in systolic blood pressure \>20% after 2 minute standing),
* Congestive heart failure (NYHA class III - IV)
* Ejection fraction (EF)\<45% by Echocardiography
* Peripheral arterial obstructive disease or other diseases limiting exercise testing
* Arrhythmias requiring active treatment
* Gastro-intestinal ulcer
* Liver dysfunction (defined as ALT or bilirubin\>1.5×upper limit of normal value)
* Significant renal impairment, such as serum creatinine greater than 1.5 folds the upper limit of normal as determined by local clinical laboratory
* Glaucoma
* Concomitant medication such as Trimetazidine, Sulphonylurea, PDE-5 inhibitor such as sildenafil, Chinese traditional medicine for treatment of angina pectoris
* Known intolerance to nitrates
* Known allergic to nicotinic acid
* Pregnant or lactating women
* Any other contraindications mentioned in the SPC
* Participation in another clinical study within the last 3 months
* Legal incapacity or limited legal capacity
* Any other subjects assessed by the investigator as being unsuitable for the present study
Safety Study Using Transcranial MR Guided Focused Ultrasound in the Treatment of Neuropathic Pain

The aim of this study is to asses the efficacy and the clinical safety of the transcranial magnetic resonance guided high intensity focused ultrasound system ExAblate 4000, InSightec Ltd. for functional neurosurgery. The treatments to be conducted in this study are non-invasive, i.e. without opening the skull, and will create micro-thalamotomies in specific target areas such as thalamus, subthalamus and pallidum. The data obtained in this study will be used to evaluate the basic safety aspects of this new treatment technology and will serve as a basis for the clinical introduction of MR-guided ultrasound-neurosurgery.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 18 years and older
2. Clinical indication for a medial thalamotomy
3. Stereotactic targets within thalamus, subthalamus and pallidum
4. All targets supposedly accessible by TcMRgFUS
5. Physically and mentally able to understand the risks of participating in this study and to give written informed consent based on the patient information provided
6. Sufficient proficiency in one of the languages German, French, Italian or English to al-low for verbal communication during all phases of the study
7. Physically and mentally able to communicate the personal condition and all feelings during the TcMRgFUS treatment
8. Physically and mentally able to undergo the TcMRgFUS treatment

Exclusion Criteria:

1. Anomalies of brain anatomy, especially in or around thalamus or pallidum that will in-fluence the atlas-based navigation
2. Existing lesions in close proximity (\<5mm) to planned ablation targets
3. Extended anomalies of scalp such as scars, inflammations, etc.
4. Clips or other implanted objects close to (\< 3cm) target
5. Non-MRI-compatible cardiac pacemaker
6. Previous hemorrhages in the brain
7. Uncontrolled arterial hypertension
8. Any coagulopathy or patient under anticoagulant therapy
9. Sensitivity to MRI contrast agents
10. Contraindications to MRI such as non-MRI-compatible implanted devices
11. Large patients not fitting comfortably into the MRI unit (generally \>110kg)
12. Difficulty to lie supine and still for up to 4 hours in the MRI unit or claustrophobia
13. Other known life-threatening systemic disease
14. Patients currently participating or participated in another clinical trial in the last 30 days
A Modified Placement of Two Additional Pedicle Screws at the Fracture Level for the Treatment of Thoracolumbar Burst Fractures--a Study Protocol of a Randomised Controlled Trial

Controversies exist about the best treatment of burst fractures of the thoracolumbar spine. Adding screws in fractured segment has been proved in many literatures that can improve construct stiffness but sometimes aggravate the trauma of fractured vertebra. Therefore, we are eager to find an optimized placement of two additional pedicle screws at the fracture level for the treatment of thoracolumbar burst fractures. This is the first randomised controlled study investigating efficacy of diverse orders of pedicle screws placement and will provide recommendations for treating patients with thoracolumbar burst fractures.

A blinded randomised controlled trial (blinding for the patient and statistician, rather than for the clinician and researcher) will be conducted. A total of seventy patients with single thoracolumbar AO type A3 or A4 fractures who are candidates for application of short-segment pedicle screws of fractured vertebrae will be randomly allocated to either the DS group (distraction-screws ) or the SD group (screws-distraction) at a ratio of 1: 1. The primary clinical outcome measures are compression ratio of anterior border of vertebral body height, depth of nail into injured vertebrae and kyphosis (Cobb) angle. Secondary clinical outcome measures are complications, Visual Analogue Scale (VAS) of back and leg pain, neurological function, operating time, intraoperative blood loss, Japanese Orthopaedic Association (JOA) scores and Oswestry Disability Index. These parameters will be evaluated preoperatively, intraoperatively, on day 3 postoperatively and then at 1, 3, 6, 12 and 24 months postoperatively.

Eligibility Criteria:
Inclusion criteria

1. 18 years of age or above.
2. single thoracolumbar burst fractures
3. AO type A3 or A4 fractures
4. Thoracolumbar Injury Classification and Severity Score (TLICS) of more than 4 and duration of \< 2 weeks
5. application of posterior short-segment pedicle screws instrumentation at the fracture level Exclusion criteria

1. previous pedicle instrumentation at the same level 2. multi-segmental thoracolumbar fractures or not AO type A3 or A4 are found 3. pregnancy 4. active infection or surgical site of the previous infection 5. planned emigration abroad within 2 years after inclusion 6. suffering from illness or long-term use of certain drugs affecting the stability of the spinal environment, such as metabolic bone disease, spinal tuberculosis and so on 7. the current use of anticoagulant (such as warfarin) or postoperative heparin for more than 6 months
Characterizing Bilateral Hypoglossal Nerve Stimulation During Drug-Induced Sleep Endoscopy

The study will investigate the treatment effect of bilateral genioglossus muscle stimulation on upper airway collapsibility during drug-induced sleep endoscopy in patients implanted with the Inspire hypoglossal nerve stimulator.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 22yrs) willing and capable of providing informed consent
* Implanted with the Inspire hypoglossal nerve stimulator

Exclusion Criteria:

* • Pregnant women\*
Evaluation of a Novel Post-Surgical Dressing

The purpose of this study is to evaluate the safety and efficacy of the Closed-Incision SNaP Device.


Eligibility Criteria:
Inclusion Criteria:

* Surgically closed incision.
* Subject is 18 years of age or older.
* Subject consents to follow-up per protocol.
* Willing and able to sign informed consent.

Exclusion Criteria:

* Subject is allergic to wound care products used in this study.
* Subject has wounds with exposed blood vessels not suitable for negative pressure therapy.
* Pregnant or pregnancy-suspected subject.
* Subject actively participating in other clinical trials that conflict with the current study.
* Subject is unable or unwilling to comply with protocol requirements.
Problem Solving Skills Training in Adult Cancer Survivors: Bright IDEAS-AC

The aim of this 2-year study will assess the acceptability and feasibility of offering Problem Solving Skills Therapy (PSST) to cancer survivors and their caregivers focusing on the highest risk patients with distress.

At Roswell Park Comprehensive Cancer Center, in collaboration with the University at Buffalo School of Public Health and Health Professions and the University of Rochester, we are looking for adult cancer patients to participate in our new project designed to facilitate recovery from cancer and help cancer survivors lead better, more productive lives. The ideal subjects are individuals who have completed treatment for stage I-III cancer and speak English. Participants will be randomized into two groups: 8 weekly 1-hour long sessions of problem solving skills therapy delivered by a trained therapist vs. care as usual. Bright IDEAS Adult Cancer (Bright IDEAS-AC) therapy will be delivered in the most patient-friendly way. Sessions will be face-to-face at the location of patient choice (hospital, clinic, or participant's home) or over the phone. A supportive other or caregiver is also invited to participate in this study. This project does not involve any experimental drugs and does not affect the regular care or patient relationship with doctor(s).

At the time of enrollment, after 3 months and after 6 months, all participants in the intervention and control arms, as well as any participating supportive others/caregivers will be asked about their healthcare utilization since the last assessment including primary care, specialist and emergency department visits and any hospital stays. During the same three time points, both patients and supportive others/caregivers will be asked to fill in 4 short questionnaires assessing their problem solving skills, health status, mood and function

Eligibility Criteria:
Inclusion Criteria:

* stage I-III Colorectal Cancer, Breast, Bladder or Prostate Cancer
* meet the screening criteria for psychological distress (NCCN Distress \>2)
* be able to speak English
* have a 5-year survival rate of 50% or greater as deemed by their oncologist, surgeon,or other relevant attending physician (suggesting a reasonable rate of cure or prolonged medical survival with state-of-the-art medical care)
* be willing to provide written informed consent to participate in the study which includes several clinical evaluations, provide access to medical records/PCP, and allow all interviews and PSST therapy sessions to be audiotaped.
* Among patients treated in the urban centers, we will specifically target patients who live more than 40 miles away from the clinic as they are more likely to experience problems with access to care.
* Age 21 or older

Exclusion Criteria:

* a diagnosis of mental retardation,
* and/or acute suicidal behavior
Interruption of Dorsal Visual Stream Using TMS

Trans Cranial Magnetic Stimulation (TMS) over dorsal visual system will disturb the ability to identify objects with decreased level of fragmentation

The participants performed two tasks under three different TMS conditions: no TMS, 10Hz TMS for over the dorsal stream (PO3 EEG site) or over the vertex.

First they performed a perceptual closure task which asked them to identify an object in a series of six progressively less degraded pictures.

Then, they also performed a control task previously shown not to be mediated by the LOC and not to be impaired in schizophrenia: The perception of illusory contours.

Eligibility Criteria:
Inclusion Criteria:

* Normal controls

Exclusion Criteria:

* neurological, ophthalmological or psychiatric problems
* family history of schizophrenia
* left handed
Laser Therapy on Neck Pain in Adolescents

The aim of the proposed study is to investigate the effects of low-level laser therapy on neck pain.


Eligibility Criteria:
Inclusion Criteria:

* age 14 to 20 years;
* chronic neck pain;
* no use of corticoids for at least 15 days prior to the onset of treatment;
* agreement to participate; and
* signed statement of informed consent by legal guardian.

Exclusion Criteria:

* Currently undergoing physical therapy;
* inability to participate in sessions;
* specific diagnosis of infection, osteoporosis, polyarthritis or rheumatic disease; and
* constant use of corticoids or analgesics.
Quantitative Computed Tomography for Mortality Risk Stratification in ARDS

Acute respiratory distress syndrome remains a deadly disease with hospital mortality remaining between 40 to 50%. ARDS mortality risk factors have been identified from patient history, common clinical and biological variables in the lung SAFE study. Part of ARDS mortality is attributable to ventilator-induced lung injury (VILI), in relation with inappropriate settings on the ventilator. Tidal hyperinflation and recruitment/derecruitment during lung inflation are 2 identified mechanisms leading to VILI, that may be identified on computed tomography while poorly identified with variables collected at the bedside.

The aim of this study is to identify whether tidal hyperinflation identified on computed tomography is a risk factor for ARDS mortality, independently from know bio-clinical risk factors.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 15 or older with ARDS according to the Berlin definition
* invasive mechanical ventilation with PaO2/FiO2 ≤ 300 mm Hg
* with computed tomography acquired at both end-expiration and end-inspiration, or at both PEEP 5 and 15 cm H2O at end-expiration
* PEEP setting according to a PEEP/FiO2 table, with secondary adjustment according to hemodynamic tolerance
* Tidal volume 6 ml/kg of predicted body weight or less

Exclusion Criteria:

* Use of contrast agent during computed tomography acquisition
* ARDS criteria onset since more than 72 hours or ECMO onset since more than 72 hours
* Proven COPD
* Pneumothorax or bronchopleural fistula
* Patient with spontaneous breathing preventing realization of end-expiratory and end-inspiratory pauses
* Previous inclusion in current study
* Patient under a legal protective measure
A Study of SYHA1807 in Subjects With Extensive-Stage Small Cell Lung Cancer

This is a phase I, open-label, multi-center, non-randomized, 2-part first time inhuman (FTIH) study for SYHA1807. Part 1 is a dose escalation phase to determine the recommended phase 2 dose (RP2D) for SYHA1807 based on the safety, tolerability and pharmacokinetics (PK) profiles observed after oral administration of SYHA1807. The dose escalation study will be performed according to the 3+3 design. Once RP2D is identified, an expansion cohort (Part 2) of up to 12\~40 subjects will be enrolled to further evaluate the clinical activity and tolerability of SYHA1807 in subjects with extensive-stage Small Cell Lung Cancer (SCLC).


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of advanced SCLC;
* ECOG(Eastern Cooperative Oncology Group) performance status of 0 or 1;
* Measurable disease according to RECIST v1.1;
* Recovered from all toxicities associated with previous treatments;
* Life expectancy ≥ 3 months;
* Adequate organ function;
* Use of reliable contraceptive methods;
* Signed informed consent from the patient;

Exclusion Criteria:

* Patients with primary malignant tumor other than small cell lung cancer;
* Identified central nervous system metastasis (such as brain metastasis or meningeal metastasis);
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
* Inadequate washout period for previous anti-tumor therapy;
* Previous treatment with any LSD1(lysine specific demethylase 1) inhibitor;
* Unable to swallow oral medications;
* History of serious systemic diseases;
* History of serious autoimmune diseases；
* HIV positive;
* Pregnant or lactating women.
Crisaborole Ointment for Skin Toxicity Induced by Cetuximab

This is a prospective, single-arm, phase II clinical trial that will enroll metastatic colorectal cancer patients with Cetuximab-Related Skin Toxicity, who will receive crisaborole ointment twice daily.

The efficacy of cetuximab has been demonstrated in treating metastatic colorectal cancer (mCRC). Skin toxicities, especially acneiform eruption, are the major side effects associated with cetuximab, which affect patients' quality of life and can lead to treatment discontinuation and cetuximab dose reduction.

This prospective, single-arm, phase II clinical trial aims to explore the efficacy and safety of crisaborole ointment in Cetuximab-Related Skin Toxicity. A total of 33 mCRC patients with acneiform eruption will be enrolled. All of the participants will receive crisaborole ointment twice daily. The total follow-up time is 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed mCRC and undergoing Cetuximab treatment;
2. ≥2 grade EGFR inhibitor-related acneiform eruption, evaluated by National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE）5.0;
3. Age 18 years and older；
4. ECOG performance status 0-2.；
5. Bone marrow ,brain, heart, kidney and other organ function well;；
6. Expected survival time more than 3 months;

Exclusion Criteria:

1. The presence of any active skin disease；
2. Undergoing any current hormone therapy for any other disease;
3. Prior allergic reaction or severe intolerance to crisaborole ointment
Becoming United in Lifestyle Decisions

The goal of this project is to investigate how to enhance the effects of an online-only (mHealth) couples weight loss program. This study will use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to test four different strategies for weight loss and partner support in addition to a core intervention (i.e., dyadic action planning, joint feedback on goal progress, autonomy support training, and home environment modifications).


Eligibility Criteria:
Inclusion Criteria:

* Married/cohabitating couple - both partners must be eligible
* BMI between 25-55kg/m2
* English speaking/reading
* Have a smartphone and reliable internet access
* Have active email address
* Willing to videoconference

Exclusion Criteria:

* Report being unable to walk 2 blocks without stopping
* Are currently participating in weight loss treatment, have a history of bariatric surgery, or lost ≥5% in the past 6-months
* Are pregnant or plan to become pregnant during the study period
* Report chest pain or loss of consciousness on the Physical Activity Readiness Questionnaire
* Report a medical condition that could jeopardize their safety in a weight control program with diet and exercise guidelines
* Report conditions that, in the judgment of the PI, would render them unlikely to follow the protocol (e.g. dementia)