cyrilzakka/clinical-trials huggingface dataset:
Registry for Esophageal and Gastroesophageal Junction Cancer

The purpose of this registry study is to create a database-a collection of information-for better understanding standard treatments for esophageal and Gastroesophageal Junction Cancer/GEJ cancer. Researchers will use the information from this database to learn more about the effectiveness of different treatment options.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed stage IV adenocarcinoma of the esophagus or GEJ with OMD at the time of diagnosis, defined as the following:
* Retroperitoneal lymph nodes (e.g., para-aortal, intra-aorto-caval, parapancreatic, or mesenterial lymph node)
* Liver
* Lung
* Extra-abdominal lymph nodes (e.g., supraclavicular or cervical lymph nodes)
* Adrenal gland
* Unilateral or bilateral ovarian metastases (in the absence of gross or microscopic peritoneal disease \[positive cytology\])
* Bone
* ≤2 sites of disease (excluding the primary tumor and regional lymph nodes)
* ≤3 tumors within each organ system
* ≤5 metastases
* All nonregional lymph nodes (including cervical, supraclavicular, and retroperitoneal nodal disease) are considered 1 discrete lesion
* Satellite lesions in the primary esophageal malignancy, such as skipped esophageal primaries, are not considered metastatic sites
* All sites of disease must be amenable to complete local therapy after systemic therapy, according to the treating physician. Treatment modalities include:
* Surgery
* Definitive chemoradiation
* Stereotactic radiation
* Ablation or similar techniques (e.g., irreversible electroporation)
* Age ≥18 years

Exclusion Criteria:

* Presence of metastases, at the time of diagnosis, to the following:

  * Peritoneum, including positive peritoneal lavage (on the basis of baseline diagnostic laparoscopy to rule out gross disease and positive peritoneal lavage cytology; laparoscopy may be omitted for patients in whom all sites of disease are above the diaphragm)
  * Malignant pleural effusion
  * Brain metastases or leptomeningeal disease
  * Other sites not specifically noted must be reviewed and approved by the PIs
  * Any site of disease that is not amenable to definitive local therapy
* Unfit for best systemic therapy
* Metachronous OMD
* Secondary primary cancer, with the exclusion of basal cell carcinoma of the skin
* Pregnant, lactating, or intending to become pregnant
* Unwilling to provide informed consent
Does Less Trendelenburg Make a Difference in Robotic Assisted Gynecological Procedures?

Patient/Population: Women over the age of 18, who are not pregnant and are undergoing benign, robotic-assisted gynecologic procedures at Lutheran General Hospital.

Intervention: Decreasing the angle of Trendelenburg for the procedure Control: Steep Trendelenburg, which is the usual standard of care, to the limit of the operative bed, which is 30 degrees.

Outcome: Outcomes will include the mean angle of Trendelenburg in the experimental arm and the difference in Trendelenburg between the two arms. Additional outcomes included will be end tidal Carbon dioxide, peak airway pressure, mean arterial pressure, heart rate and arterial Carbon dioxide. Secondary outcomes will include operative time, blood loss and conversion to laparotomy.

For any patient undergoing robotic-assisted benign laparoscopic procedures at Lutheran General Hospital were eligible to participate. Each subject was randomized to steep or a decreased angle of Trendelenburg. While under anesthesia an arterial line would be placed to monitor vital signs. At specific time points throughout surgery, all vital signs were measured including End Tidal CO2, peak airway pressure, mean arterial pressure, heart rate and arterial CO2 as well as operative time, blood loss and conversion to laparotomy.

The arterial line was removed at the conclusion of the case, and all variables will be compared between the two cohorts.

Eligibility Criteria:
Inclusion Criteria:

* all women at Lutheran General Hospital undergoing robotic-assisted benign gynecologic procedures and who agree to participate in the study.
* Women who are 18 years or older on the day of surgery.
* Patients with any co-morbidity or prior surgery, as long as they are cleared by their surgeon and anesthesia to undergo robotic-assisted surgery.

Exclusion Criteria:

* pregnant women
* Anyone who is less than 18 years old on the day of surgery.
* Anyone who does not have the capacity to make independent medical decisions.
Risk Factors for Long-term Opioid Use

Surgeons often see patients with pain to exclude organic pathology and consider surgical treatment. We examined factors associated with long-term opioid therapy among patients with foot/ankle, anorectal, and temporomandibular joint pain to aid clinical decision making.

Using the IBM MarketScan® Research Database, we conducted a retrospective cohort analysis of patients aged 18-64 with a clinical encounter for foot/ankle, anorectal, or temporomandibular joint pain (January 2007-September 2015). Multivariable logistic regression was used to estimate adjusted odds ratios for factors associated with long-term opioid therapy, including age, sex, geographic region, pain condition, psychiatric diagnoses, and surgical procedures in the previous year.


Eligibility Criteria:
Inclusion Criteria:

* 18-64 years old
* at least one encounter for anorectal, foot/ankle, or TMJ pain
* Marketscan continuous enrollment for 1 year prior and 1 year after the index pain encounter
DermaClose DUKE Fasciotomy and Wound Study

To evaluate the clinical performance of DermaClose and DermaClose XL Continuous External Tissue Expander (CETE) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the need for skin grafting for patients undergoing a four-compartment leg fasciotomy.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age at the time of consent.
* Patient with a full thickness acute wound(s) of the skin:

  1. On either the upper or lower extremity (including four-compartment leg fasciotomy), in whom DermaClose and/or DermaClose XL is applied during surgery, OR
  2. Undergoing a four-compartment leg fasciotomy requiring conventional wound dressing.
* Patient has signed a written informed consent form (ICF) per 21 Code of Federal Regulations (CFR) Part 50.55(e).

Exclusion Criteria:

* Patient in whom the product was used off-label (except for patients who have the device on for longer than 14 days)
* Patient with wound(s) that exhibit any of the following:

  * Ischemic tissue,
  * Infected tissue,
  * Acute burned tissue,
  * Fragile tissue at the edges of the wound(s).
* Patient, who in surgeon's opinion, does not fit the criteria for this study.
OTL38 for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.

The Phase 3 study is to confirm the efficacy of OTL38 in combination with fluorescent light to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery

Eligibility Criteria:
Inclusion Criteria:

* Female patients 18 years of age and older
* Have a primary diagnosis, or at high clinical suspicion, of primary ovarian cancer (of epithelial type), planned for primary surgical cytoreduction, interval debulking, or have recurrent ovarian cancer surgery, and:

  * Who are scheduled to undergo laparotomy for the debulking surgery OR
  * Who are scheduled to undergo laparoscopy and pre-authorized to undergo laparotomy for the debulking surgery if cancer is detected on the laparoscopy
* A negative serum pregnancy test at Screening followed by a negative urine pregnancy test on the day of surgery or day of admission for female patients of childbearing potential
* Female patients of childbearing potential or less than 2 years postmenopausal agree to use an acceptable form of contraception from the time of signing informed consent until 30 days after study completion
* Ability to understand the requirements of the study, provide written informed consent for participation in the study and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments

Exclusion Criteria:

* Previous exposure to OTL38
* Known FR-negative ovarian cancer
* Planned surgical debulking via laparoscopy or robotic surgery, with no intent of laparotomy.
* Patients with known ovarian cancer miliary disease determined preoperatively to be inoperable.
* Any medical condition that, in the opinion of the investigators, could potentially jeopardize the safety of the patient
* History of anaphylactic reactions
* History of allergy to any of the components of OTL38, including folic acid
* Pregnancy or positive pregnancy test
* Clinically significant abnormalities on electrocardiogram (ECG)
* Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Impaired renal function defined as eGFR\< 50 mL/min/1.73m2
* Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
* Known Stage IV ovarian cancer with brain metastases
* Received an investigational agent in another clinical trial within 30 days prior to surgery
* Known sensitivity to fluorescent light
Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)

Physiotherapist research about Sensory rehabilitation in chemotherapy induced peripheral neuropathy (CIPN) with the aid of questioners and physiotherapy practice


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over who suffer from chemotherapy-induced neuropathy (CIPN), according to the patient's report, more than 3 months since the end of the chemotherapy treatment.

Exclusion Criteria:

1. Sensory damage / neuropathy that existed even before the start of chemotherapy
2. Incidents of recurrent falls even before the start of chemotherapy (over 2 falls for 6 months)
3. Central nervous system involvement
4. Major pre-morbid orthopedic lower limb impairment
5. Hebrew language not sufficient for assessment and treatment
Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of any race, aged 18 to 50 years inclusive
* Subjects with a past history of acne and with moderate to severe facial atrophic acne scars

Exclusion Criteria:

* Subjects with active inflammatory acne lesions
* Subjects with hypertrophic acne scars
Hemathologic and Imagiologic Predictors of Stroke During Carotid Endarterectomy With Regional Anesthesia

Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.

The authors hypothesize FGF-23 and GDF-15 could predict cerebral ischemia, postoperative complications and long term major cardiovascular events, particularly in patients developing symptomatic neurologic ischemia after circulation shutdown.

Establish and validate biomarkers which improve the predictive value of current risk stratification models for patients benefiting from carotid revascularization, outperform existing biomarkers, and reach clinical application standards.

Clarify the pathophysiology of carotid endarterectomy-related stroke and the role of GDF-15, FGF-23, BNP and hs-troponin I and other biomarkers in the prognosis of symptomatic carotid stenosis.

Imagiologic markers are to be included - intima-media; gray weale plaque classification, cerebral CT Peak wave velocity

Eligibility Criteria:
Inclusion Criteria:

- consecutive patients from a tertiary referral center who undergo CEA for carotid artery stenosis (CS) under regional anesthesia

Exclusion Criteria:

* general anesthesia
* carotid stenting
The Impact of a Novel Coaching Program on Medical Errors and Well-Being of Physicians

This is a randomized controlled trial with a mixed method design to determine the impact of coaching on self-perceived medical errors, burnout, and resilience. The study team developed a novel coaching curriculum based in principles of positive psychology and self-reflection with the hypothesis that the coaching intervention will lead to decreased medical errors, decreased burnout, and increased resilience in trainee and faculty participants. Resident and fellow trainees as well as faculty members were recruited across departments and randomized to coaching or control. Faculty in the coaching arm were trained in coaching techniques and paired with a trainee coachee. Survey results as well as focus groups will be used to analyze the impact of the coaching program as compared to standard mentorship (control).


Eligibility Criteria:
Inclusion Criteria:

* Residents and fellows in a training program at Beth Israel Deaconess Medical Center (BIDMC)
* faculty members at BIDMC
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.


Eligibility Criteria:
Key Inclusion Criteria:

* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

Key Exclusion Criteria:

* Any other chronic liver disease
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Clinical hepatic decompensation
* Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor

Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
Endoscopic Ultrasound (EUS)-Guided Ablation of Pancreatic Cysts

The purpose of this study is to track outcomes and complications of patients at IUMC referred by physicians for EUS-guided pancreatic cyst ablation. This information is essential in order to disseminate future published information to physicians about this technique. A database will be created to track these patients undergoing an already scheduled/planned procedure. Phone calls at selected intervals will be made following the procedure to track any complications that occur

Pancreatic cysts represent a wide spectrum of lesions. Many cysts are uniformly benign (pseudocysts) or have negligible malignant potential (serous cystadenomas). However, others represent premalignant (i.e. intraductal papillary mucinous neoplasms (IPMNs) or mucinous cystadenomas \[MCN\]), or malignant (i.e. invasive IPMNs or mucinous cystadenocarcinomas) tumors. Management of pancreatic cysts is challenging but surgery is generally recommended for cysts that are symptomatic, premalignant (except possibly branch duct IPMNs) or demonstrate malignancy by imaging features and/or biopsy. However, even in experienced hospitals, surgical resection or enucleation of pancreatic cystic tumors is associated with significant perioperative morbidity and mortality rates of 20-40% and up to 2%, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Patients referred between January 2009 and February 2016 to EUS at IUMC for pancreatic cyst ablation and with no contraindications for anticipated safe and successful performance of the procedure.
2. Patient at least 18 years of age.

Exclusion Criteria:

1. Investigator deems cyst does not meet safety or need for cyst ablation.
2. Subject not competent to sign consent
Study of Eyes and Attention Deficit (SEAD)

Attention-Deficit Hyperactivity Disorder (ADHD) is considered to be one of the most prevalent chronic health conditions in children. It affects between 4% and 12% of young children. A relationship between convergence insufficiency (eye teaming) and ADHD has been shown. However, the effect of ADHD medications on focusing and eye teaming has not been previously investigated. Therefore, the purpose of this study is to determine the effect of ADHD medication on focusing and eye teaming skills.


Eligibility Criteria:
Inclusion Criteria:

* Best corrected visual acuity of 20/25 in both eyes at distance and near;
* Willingness to wear eyeglasses or contact lenses to correct refractive error, if necessary;
* 500" random dot stereopsis

Exclusion Criteria:

* Amblyopia (lazy eye);
* Eye disease
Abdominal Versus Vaginal Hysteropexy

This study will compare the vaginal versus the abdominal approach for the management of uterine prolapse

this study compares The unilateral sacrospinous hysteropexy with prolene sutures versus the abdominal sacral hysteropexy using Mersilene suture for the management of uterine prolapse

Eligibility Criteria:
Inclusion Criteria:

* Uterine Prolapse

Exclusion Criteria:

* Previous prolapse surgery Hereditary Connective tissue disorders
A Clinical Comparison of Two Soft Multifocal Contact Lenses

The study objective was to gather short-term clinical performance data for two soft multifocal contact lenses.

The aim of this subject-masked, non-randomized, non-dispensing study was to evaluate the short-term clinical performance of a soft multifocal hydrogel contact lens when compared to a soft silicone multifocal hydrogel lens after 15 minutes of daily wear each.

Eligibility Criteria:
Inclusion Criteria:

1. They were at least 42 years of age and had capacity to volunteer.
2. They understood their rights as a research subject and were willing and able to sign a Statement of Informed Consent.
3. They had had a full eye examination within the past two years (by self-report).
4. They were willing and able to follow the protocol.
5. They habitually used vision correction for near vision (multifocal soft contact lenses, sphere lenses for monovision, sphere lenses for distance vision correction and spectacles for near vision correction, or had a different spectacle prescription for distance and near vision correction) and had done so for at least the past three months.
6. They had refractive astigmatism of no greater than -0.75DC.
7. They could be fitted with the study lenses within the power range available, and achieved binocular distance HCVA of +0.20 or better in the study lenses.

Exclusion Criteria:

Subjects were not eligible to take part in the study if:

1. They had an ocular disorder which would normally contra-indicate contact lens wear.
2. They had a systemic disorder which would normally contra-indicate contact lens wear.
3. They were using any topical medication such as eye drops or ointment.
4. They were aphakic.
5. They had had corneal refractive surgery.
6. They had any corneal distortion resulting from previous hard or rigid lens wear or had keratoconus.
7. They were pregnant or lactating.
8. They had an eye or health condition including an immunosuppressive or infectious disease which could, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
CHOICES3: Sickle Cell Disease Parenting CHOICES

The study will use web-based data collection (SCKnowIQ) and intervention delivery strategies enhanced by nudges and tailored boosters in a sample of 430 adult men and women, aged 18-45 yr with SCD (Sickle Cell Disease) or SCT (Sickle Cell Trait), at-risk, and planning within 2 years to have a child free of SCD.

In a 2-year, randomized, longitudinal, repeated measures, controlled trial in 430 at-risk young adults with SCD (50%) or SCT (50%) to compare the effects of e-Book (electronic-Book) and CHOICES interventions on knowledge and behaviors across time (baseline, immediate posttest, 6, 12, 18, 24 months). The study will provide boosters tailored to knowledge deficits at 6 and 12 months and add monthly reinforcement nudges toward concordant behavior during the first 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SCD (HbSS, HbSC (Hemoglobin Sickle C Disease), HbS-beta-0 thalassemia, and HbS-beta+ thalassemia) or report of SCT (SCD is Hgb electrophoresis confirmed; SCT evaluated by SickleScan);
* Able and intends to conceive a child in the next 2 years (first child or another child);
* Speaks and reads English;
* 18 to 45 years;
* At-risk for having a child with SCD (i.e., sexual/ reproductive partner has SCD, SCT, or unknown sickle cell status); and
* Wants to avoid the risk of a child with SCD.
* The age range is based on typical reproductive age for SCD where median survival is 42 years for men and 48 years for women.

Exclusion Criteria:

* Legally blind;
* Physically unable to complete the study questionnaires or the intervention;
* Report health history of hysterectomy, tubal ligation, medically or surgically induced menopause, or vasectomy that would
* Prevent ability to bear children;
* Report a desire to remain childless or have no further children;
* Report knowing or being a relative or friend of a participant previously enrolled in the study, or
* Previous participation in a CHOICES study.