cyrilzakka/clinical-trials huggingface dataset:
Unified Protocol: Community Connections

The purpose of this study is to administer the Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children (UP-C) and Adolescents (UP-A) to youth and participants' parents and to examine the efficacy and outcomes of the treatment using standardized measures, questionnaires, interviews. The UP-C and the UP-A are cognitive-behavioral therapies to treat emotional disorders.


Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 7-17.
* Youth currently resides in Miami-Dade County.
* Children and their parents must be able to speak and understand English and/or Spanish sufficiently well to complete study procedures (e.g., provide their informed consent/assent, complete assessment measures and/or program materials).
* At least one parent or caregiver with whom the child is living with that can accompany the child and participate in all visits (assessment and treatment).
* Positive endorsement of elevated emotional concerns in one of a limited range of emotional disorder domains (i.e., anxiety, depression, trauma, or obsessive-compulsive symptoms, etc.) during full DIAMOND-Kid semi-structured interview, and/or elevated anxiety or depression symptoms (T-Score \> or = 65 for youth 8-17 years old; Raw score \> or = 12 for children under 8 years old) on the Revised Child Anxiety and Depression Scale - Short Form (RCADS-SF; Child or Parent Report).
* Youth with other types of comorbid conditions (e.g., tic/Tourette's disorder, eating disorders, or disruptive behavior disorders) will not be excluded, providing a clinical area of concern is regarding one of the emotional disorder domains specified and treatment within this protocol is deemed most appropriate.
* Youth and parent participation in at least one in-person session if the treatment is predominantly delivered virtually.

Exclusion Criteria:

* Prior receipt of at least 8 sessions of the UP-C/A program at the Child and Adolescent Mood and Anxiety Treatment Program (CAMAT).
* Psychiatric hospitalization in the previous 6 months (i.e., due to Baker Act, psychotic symptoms, significant suicidal ideation, danger to self or others, etc.).
* Another significant problem area that takes priority for services (e.g., eating disorder, substance-use disorder, primary externalizing concerns, psychotic symptoms, etc.), as identified by family report or via DIAMOND-Kid interview.
* Inability for family to wait for the next group treatment cohort to start, family declining therapist assignment following intake, and/or family no-showing to 3 or more scheduled sessions at CAMAT (inclusive of intake assessment).
Evaluation of Anti-Inflammatory Treatment in Dry Eye Patients

The purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global Visual Analog Scale (VAS) discomfort score.

Following Run-In, patients qualifying for treatment were randomized 1:1 to receive Durezol (experimental group) or Vehicle (control group) for 5 weeks.

Eligibility Criteria:
Inclusion Criteria:

Normal subjects:

* No known history of dry eye disease.
* Non-contact lens wearer.
* No current use of artificial tears or any other dry eye treatment.

OR

Dry eye patients:

* At least a 6 month history of dry eye.
* Non-contact lens wearer.
* Uses artificial tears.
* Experiences persistent ocular discomfort.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* The presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of Visit 1.
* Severe Sjogren's Syndrome.
* Lid function abnormalities.
* Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1.
* History of corneal surgery including refractive surgeries.
* History of glaucoma or ocular hypertension
* Other protocol-defined exclusion criteria may apply.
Transluminal Flexible Endoscopic Procedure in Foregut and Urologic Surgery

NOTES access is safe and feasible in the controlled human setting and comparable to standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate visualization comparable to laparoscopy.

This is a prospective clinical trial to evaluate the feasibility of obtaining peritoneal cavity access from natural orifice translumenal endoscopic surgery (NOTES) during combined laparoscopic-endoscopic foregut surgery. Post-operative course will be compared with a historical chart-review control group of patients undergoing standard laparoscopic foregut and urologic surgery.

The study group will be compiled by open enrollment for male and female adult subjects scheduled for combined laparoscopic-endoscopic surgery of the stomach, abdominal esophagus, prostate, bladder, proximal small intestine or who meet inclusion and exclusion criteria. The historical chart-review control group will be randomly chosen from patients from 2003-2006 having undergone combined laparoscopic-endoscopic surgery of the foregut, prostate, or bladder and as determined by CPT coding.

The purpose of the study is to determine if NOTES access and abdominal exploration is feasible, safe, offers comparable visualization to laparoscopy in a controlled human setting.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing an already combined laparoscopic and endoscopic foregut procedure with general anesthesia
* Patients undergoing a prostatectomy or cystectomy with general anesthesia
* All patients will have a planned gastrotomy for exploration, foreign body removal, or removal of tissue, making it a contaminated case or a planned cystotomy or urethrotomy for exploration, foreign body removal or removal of tissue such as prostatectomy or bladder resection.
* No overwhelming medical co-morbidities
* Subject is 18 years of age or older
* Subject is his or her own medical decision maker
* Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form

Exclusion Criteria:

* Patients undergoing a non-palliative procedure in the face of resectable adenocarcinoma of the foregut or genitourinary tract
* Linitis Plastica
* Evidence of Active Bowel Obstruction
* Patients with history of oropharyngeal, esophageal, or gastric adenocarcinoma.
* Esophageal stricture prohibiting passage of an endoscope
* Urethral stricture prohibiting passage of an endoscope
* Emergent Surgery
* At any time during pre-operative or intra-operative periods, evidence of unresectability is demonstrated
* Any intra-operative condition prior to surgical resection that results in abortion of the surgical procedure
* Any contraindication to surgery
* Pregnancy or actively breastfeeding women
* Prisoners or Wards of State
Monitoring Alectinib Treatment by Detection of ALK Translocations in Serial Blood Samples From Non-Small Cell Lung Cancer Patients

Circulating tumor DNA can be used to monitor the treatment effect and identify developing resistance mutations during ALK directed TKI treatment.

The purpose and objectives of the non-interventional study with primary data collection is

* To determine if monitoring the amount of translocated DNA in the blood reflects alectinib treatment effect.
* To assess the presence and type of resistance mutations using ctDNA at the time patients experience clinical progression on alectinib.
* To investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with ALK translocated metastatic NSCLC, treated with alectinib as 1st line therapy in routine clinical practice
2. Written (personally dated and signed) informed consent

Exclusion Criteria:
Impact of Vendor Systems on Ambulatory Medication Safety

Our objective is to determine the effects of electronic prescribing on medication safety including medication errors, near misses and preventable adverse drug events in the ambulatory setting. Study design will be a longitudinal evaluation of errors early after implementation and after sustained use.

We will compare the effects of different vendor-based electronic prescribing systems on ambulatory medication safety in various settings, including rural and underserved areas and determine the effects of electronic prescribing systems on ambulatory medication safety over time.

Eligibility Criteria:
Inclusion Criteria:

* \>=0.75 FTE providers

Exclusion Criteria:

* \<0.75 FTE providers
Rapid Genetic Diagnosis Employing Next Generation Sequencing for Critical Illness in Infants and Children

Under the joint efforts of genetic and intensive expert, to establish the high-throughput whole exon sequencing(WES) and analysis all the possible pathogenic genes. To provide patient with the appropriate treatment for genetic disease. Besides, it can identify the genetic factor of idiosyncrasy or susceptibility to explain the medical difficulties and give patients personalized advice.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients admitted to intensive care unit
* Infants with abnormal newborn screening result that is medical emergency

Exclusion Criteria:

* Participants or parents who cannot comply with study
Sentinel Lymph Node Navigation Surgery Using Near-infrared Imaging in Early Esophageal Cancer

The esophageal squamous cell carcinoma (ESCC) has high prevalence and mortality in China, which become a severe challenge for public health. Esophagectomy is the preferred choice for the patients who are diagnosed with ESCC in early stage .Although three-field lymphadenectomy has improved patient survival and reduced tumor recurrence, Surgery-related complications increased dramatically.

It has become a research hotspot to find an effective detection method to identify the lymph node metastasis of ESCC and avoid ineffective expanded lymphadenectomy .The molecular imaging technology has been developed for intra-operative visualization and precise resection of the tumors.

Indocyanine Green for Injection (ICG) has been used as a contrast agent in the near-infrared imaging system for the surgical navigation technology, which has a relatively positive effect in the clinical application of gastric cancer and liver cancer.There are few reports on the application of ICG near-infrared imaging tracer lymph nodes in the surgery of ESCC. This study intends to identify the detection rate of sentinel lymph node (SLN) and determine the accuracy of regional lymph node metastasis in ESCC by ICG near-infrared imaging technique, which provides clinical evidence for subsequent precise resection of the lymph nodes.

This will be one-arm prospective trial. The ESCC patients will be recruited with strict criteria. 84 patients will be enrolled between18 and 75 years old, without gender limit. The submucosal injection of ICG will be performed preoperatively by gastroscopy on the superior and inferior edge of the esophageal tumor. NIR fluorescence imaging will be performed intraoperatively to observe the lymph nodes. The luminescent lymph node is defined as SLN. According to the standard procedure, 3 field lymphadenectomy will be performed, and all the resected lymph nodes will be subjected to pathological analysis including correlation study of fluorescence signal and tumor tissue in pathology slice.

This clinical trial is anticipated to evaluate the detection rate of SLN in ESCC with ICG near-infrared fluorescence imaging and determine the accuracy of regional lymph node metastasis.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years old ≤ age ≤ 75 years old, gender is not limited;
2. patient who is diagnosed with ESCC and choose to proceed with surgery
3. patient with cTNM stage:T1-3N0-1M0
4. tumor located at the middle thoracic or lower thoracic esophagus
5. The main organ function is basically normal: Karnofsky score \>70%;
6. Laboratory blood tests meet surgical standards;

Exclusion Criteria:

1. pregnancy or breastfeeding
2. history of iodide or seafood allergy,
3. Patient with occult metastatic disease at the time of surgery
4. patient with mental disorder;
5. Patient who is simultaneously involved in another clinical trial;
Predictive Factors for Massive Transfusion During Liver Transplantation

Liver transplantation (LT) is the treatment of choice for patients with end-stage liver disease (1). LT is often associated with severe intraoperative blood loss and the literature has had a great interest in clarifying the predictive factors for transfusion requirements during this surgery. Despite the advances in surgical techniques, graft preservation, and anesthetic management achieved over the past two decades, intraoperative bleeding and blood component consumption during LT are still issues of current interest. The requirement for blood components is highly variable between different transplant centers and ranges from none to many units of red blood cells (RBC), plasma, and platelets per patient. Bleeding associated with LT is multifactorial. Among the pre-transplantation factors, portal hypertension and coagulation defects are of great importance. The latter can develop or amplify during the anaepatic and/or neohepatic phase due to the absence of hepatic metabolic function, hyperfibrinolysis or platelet sequestration in the graft. In the literature, the higher transfusion requirement (HTR) is associated with worse postoperative outcomes, with an increase in both the length of stay in the intensive care unit (ICU) and in hospital, and mortality.

The aim of this study is to evaluate the influence of increased transfusion requirements on the prognosis of patients undergoing LT and the risk factors for HTR. HTR is defined as the consumption of packed red blood cells (GRC) ≥ 5 units in the first 24 hours of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing liver transplantation

Exclusion Criteria:

* Age \<18 years
* Retransplantation within 30 days
* Combined kidney-liver transplantation
Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation

Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.

The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days.

All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤ 80years;
* Symptomatic CAD or documented myocardial ischemic disease;
* Up to 2 de novo lesions on native coronary arteries;
* Lesion length ≤ 29mm;
* Reference vessel diameter between ≥2.5 and ≤ 3.5 mm;
* Stenose at target lesion ≥ 70% and ≤ 99%.

Exclusion Criteria:

* STEMI within the last 72 hours pre-procedure;
* renal insufficiency;
* Left Main stenosis \> 50%;
* Ostial lesions;
* Bifurcation lesions with side branch ≥2mm;
* More than one lesion \> 50% at the target vessel;
* Left Ejection Fraction less than 30%;
* Previous (less than 6 months) PCI at the target vessel.
Hemodynamic Changes With Passive Leg Raising Maneuver in Patients Undergoing Arthroscopic Shoulder Surgery

After intubation of the patients who are undergoing arthroscopic shoulder surgery, plethysmographic waveform will be recorded with blood pressure, heart rate and end-tidal carbon dioxide values and inferior vena cava (IVC) diameter will be measured by ultrasound. New hemodynamic values will be measured after passive leg raising maneuver. Blood pressure, heart rate, end-tidal carbon dioxide values will be re-measured and plethysmographic waveform will be recorded after beach chair position for surgery.

Patients aged between 18-65 years who are undergoing arthroscopic shoulder surgery will be examined. After giving detailed information, voluntary certificate will be taken from patients who accept to participate in the study. Heart rate, oxygen saturation and blood pressure values will be recorded by routine monitoring. After intubation of the patients, plethysmographic waveform will be recorded with blood pressure, heart rate and end-tidal carbon dioxide values and IVC diameter will be measured by ultrasound. New hemodynamic values will be measured after passive leg raising maneuver. Blood pressure, heart rate, end-tidal carbon dioxide values will be re-measured and plethysmographic waveform will be recorded after beach chair position for surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old patients,
* The American Society of Anesthesiologists (ASA) physical status classification score 1-2,
* Patients scheduled for arthroscopic shoulder surgery, intubated, sitting position

Exclusion Criteria:

* Patient refusal,
* Patients with current heart and valve disease,
* Patients with ASA 3-4 status,
* Emergency cases
Fluorescence Spectroscopy Guided Surgery

Intraoperative surgical fluorescence microscopy is a useful technique for the surgical resection of glioma. However the accuracy of this method is limited by its too low sensitivity. Fluorescence spectroscopy has the potential capacity to overcome the current limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure two-peaked 5-ALA-induced protoporphyrin IX (PpIX) fluorescence emission spectrum which clearly enables to distinguish the solid component of glioblastomas from low grade gliomas and infiltrative component of glioblastomas. This innovative method could become in future a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. However, those preliminary ex-vivo results have to be confirmed in a feasibility in-vivo study on human.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old
* Clinical signs and history of the disease in favor of a HGG, LGG
* MRI study in favor of a HGG, LGG, meningioma or brain metastasis
* Affiliated to or beneficiary of a social security system (or equivalent).
* Patients who have provided written informed consent for the study

Exclusion Criteria:

* Previous life-threatening allergic reactions and known hypersensitivity
* Pregnant or lactating or not using effective contraception;
* Restricted renal function define by a creatinine clearance \< 30ml/min
* Patients under a beta-blockers treatment
* Contraindication to do an MRI (pace-maker)
* Contraindication to the use of 5-ALA : known hypersensibility to 5-ALA or to porphyrin, acute or chronic porphyria
* Minor or adult ward of court (under guardianship or trusteeship)
* No affiliation to a social security system (or equivalent).
* Patients who express opposition to participation in the study.
Personalized Spine Study Group (PSSG) Registry

The primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with patient specific rods. The secondary objective is to collect clinical and radiographic outcomes of patients with hardware as a control cohort to the patient-specific rods.

The registry follows patient during their standard of care visits. During a standard of care visit, a study subject will be required to answer questions about themselves and fill out patient reported outcome questionnaires. Spinopelvic measurements will be collect from standard of care x-rays. This registry is observational only used to address patient outcomes sagittal profile through the pre-operative, plan and post-operative events. Rod effectiveness in conjunction with other surgical implants by fusion assessment and sagittal alignment measurements. Patient outcomes in subgroups defined by surgery performed, comorbidities, radiographic measurement, or other outcome variables. Rod curvature maintenance during the follow-up period. Better understanding of the post-operative risks and complications from the pre-operative condition.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been/ will be operated and instrumented with patient-specific rod or spine hardware (control cohort)
* Patient able to consent or assent

Exclusion Criteria:

* Patient unable to sign an informed consent form
* Patient unable to complete a self-administered questionnaire
* Patient is pregnant or planning on becoming pregnant during the duration of their study participation
* Patient is older than 85
* Patient is younger than 10
Facilitating Learning Health Care (LHC) and Neonatal Research: Effects of a Brief Introductory Discussion Between a Neonatologist and the Parents of Eligible Infants

The primary purpose of this pilot quality improvement study is to assess the impact of a brief introductory discussion about Learning Health Care (LHC) and clinical research between a neonatologist and the mothers (and the fathers, if present) of infants eligible for trials of the Neonatal Research Network (NRN) before they are approached for consent by clinical research coordinator (CRC) approach for NRN trial). Mothers will also be given a general information pamphlet addressing the same topic.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of infants eligible for Neonatal Research Network (NRN) trial (antenatal or postnatal)
* English or Spanish speaking
* Available for in-person (preference) or phone consultation meeting
* Mother not already approached for NRN trial

Exclusion Criteria:

* Mother already approached by clinical research coordinator (CRC) for NRN trial