cyrilzakka/clinical-trials huggingface dataset:
Exploratory Study Of The ERCC-1 Gene

This study is for patients with advanced or stage II and III colon or rectal cancer. The primary purpose of this research study is to determine if a particular protein in the patient's blood will change when they receive treatment with a drug called oxaliplatin, which is used to treat the colon or rectal cancer. This protein is called ERCC-1. It is thought that the amount of this protein in the blood could influence the manner in which the patient responds to oxaliplatin.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of colorectal cancer.
* ECOG Performance Status 0-2 (Appendix A).
* Patient is a candidate for oxaliplatin based therapy either in the adjuvant or in the metastatic setting.
* Consent to donate 4 tubes of PBMC of 7 ml of blood each.
* Willing to consider additional post therapy tumor biopsy if applicable (refusal to consent is not an exclusion criteria).
* Adequate organ function as defined as:

  * Neutrophil count \> 1500/μl
  * Platelets \> 75,000/ μl
  * Hemoglobin \> 8 g/dl
  * Bilirubin \< 2.0 X upper limit of normal
  * Creatinine \< 2 mg% or calculated clearance \> 40 ml/mt
* The patient must have signed a consent form approved by the Albert Einstein College of Medicine Cancer Center CCI and Montefiore Medical Center IRB

Exclusion Criteria:

* No other significant underlying medical condition that will, in the opinion of the principal investigator or designees, make administration of oxaliplatin unusually hazardous, such as significant hepatic, bone marrow and/or cardiac disease, requiring active medical treatment.
* Pregnant women or women of child bearing potential not practicing birth control or sexually active males unwilling to practice contraception during the study.
* Patients undergoing major surgical procedures (they will be delayed enrollment until complete recovery from their surgery - 4 wk for major or 2 wk from minor surgery).
* Patients with grade 2 neuropathy will not be eligible for the study.
* The patient must not have received chemotherapy within 4 weeks of beginning oxaliplatin treatment. At least 6 weeks must elapse if prior therapy included mitomycin C or nitrosoureas. At least 2 weeks must have elapsed since the end of prior palliative radiation therapy.
Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes

Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may also contribute. We plan to study the mechanisms involved in this abnormal metabolism, whilst also assessing the effects of a drug called Perhexiline which improves the abnormal metabolism that is present in diabetic patients before the development of heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus(WHO definition)
* HbA1C \<9
* No history of chest pain
* No evidence of Coronary Artery Disease or peripheral vascular disease
* Left ventricular ejection fraction over 50%
* No evidence of respiratory disease

Exclusion Criteria:

* Patients \< 16years or who cannot provide informed consent
* Evidence of significant epicardial coronary artery disease
* Evidence of peripheral vascular disease
* Abnormal liver function tests
* Clinically apparent peripheral neuropathy
* Severe chronic renal failure (creatinine \>250) or diabetic nephropathy
* Concomitant use of Amiodarone, Quinidine, Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme
* Patients on statin therapy for primary dyslipidemia.
* Patients with recurrent hypoglycaemia
* Women of child bearing age who are not using effective contraception (or if pregnancy test positive)
Minimum Effective Volume of Local Anesthetic Using Ultrasound for Brachial Plexus Block

The purpose of this study is to determine the minimum effective volume of local anesthetic for interscalene brachial plexus block using ultrasound guidance and nerve stimulator guidance.

This will be a single group assignment, double-blind, up-down sequential allocation study. Interscalene brachial plexus block (ISBPB) is a common nerve block given to patients who are undergoing shoulder surgery. This block has a low, but still significant, rate of complications. Reducing the volume of local anesthetic given during the block may allow some of these complications to be avoided. Participants will undergo ISBPB under ultrasound and nerve stimulator guidance. Patients will initially receive 15mL of local anesthetic (bupivacaine 0.5% with epinephrine). The volume used for each subsequent patient depends upon the success or failure of the previous patient's block - a failure will cause the volume given to increase by 1.0 mL, while a success will cause the volume to decrease by the same amount.

The goal of this study is to determine the minimum effective anesthetic volume of bupivacaine 0.5% providing anesthesia in patients when using ultrasound and nerve stimulator to guide placement of the block. The secondary outcome will be the evaluation of diaphragmatic function and post-surgery analgesia.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving interscalene brachial plexus block for shoulder surgery
* Age between 21 and 65 years
* ASA physical status I/II
* Body mass index \< 35 kg/m2

Exclusion Criteria:

* Chronic obstructive pulmonary disease
* Psychiatric history
* Allergy to bupivacaine
* Infection in the site of block
* Coagulation disorders
Nutrition and Coping Education for Symptom and Weight Management for Fibromyalgia

Research has shown that weight problems are very common in fibromyalgia. Research also suggests that overweight and obesity may contribute to worsening of fibromyalgia symptoms and biochemical vulnerability associated with fibromyalgia. Effective weight management may be important in not only improving general health but also better management of fibromyalgia symptoms. Research has indicated that nutrition and coping education is important aspects of successful weight management. In this study, the investigators are evaluating the effect of nutrition and coping education on weight and symptom management of fibromyalgia among overweight and obese patients.


Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia patients whose body mass index is greater than 25.
* Age 21-65 of both sex and all race.

Exclusion Criteria:

* Co-occurring progressive disease
* Planning to have surgery in the next year
* Pregnancy or planning to be pregnant in the next year
* Having known cardiovascular diseases
* Having known serious psychopathology (Diagnoses of psychosis, organic mental disorder, dissociative disorder, active suicidal intent, inpatient admission to psychiatric ward in the past year, evidence of self-injurious behaviors in the past year, current or recent history (2years) of non-IV substance abuse, any history of recreational IV drug use)
* Having autoimmune disorder (e.g., rheumatoid arthritis)
* Having neuropathic pain
* Having pain associated with terminal illness, acute pain, pain associated with specific organ damage (eg, stomach ulcer)
* Concurrent use of weight controlling medications (eg, Xenical)
* A history of weight reduction surgery
* Concurrent participation in weight loss programs or other cognitive-behavioral coping therapy
* Self-reported physician diagnosed conditions of chronic bronchitis, asthma, or emphysema
* Report history of head injury, neurological illness, diagnosis of learning disability, learning problems, or special education, substantial toxin or chemical exposure within five years of FMS onset, near drowning, recreational IV drug use
Conventional Curettage Adenoidectomy vs Curettage Adenoidectomy With Transoral Endoscopic Residue Ablation in Children

This prospective study is designed to compare short and long term results of conventional cold curettage adenoidectomy in children performed without doing any endoscopic or mirror examination before ending the operation versus when combined with transoral endoscopic residue ablation using a wand.

Residual or recurrent adenoid tissue that causes persistence or recurrence of symptoms is observed frequently after conventional cold curettage adenoidectomy. New techniques to better visualize or excise the tissue in order to prevent this situation are being developed. This study aims to compare transoral endoscopic controlled adenoidectomy with conventional blind curettage adenoidectomy in terms of recurrent adenoid hypertrophy. Although there are other studies comparing the results of the two techniques in terms of early residual adenoid tissue and bleeding, no studies comparing the long term results were found in literature. This prospective study is planned to focus on both early examination of residual tissue and long term recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients within 3-12 years old
* Patients undergoing tonsillectomy and adenoidectomy for obstructive sleep disorder
* Patients undergoing adenoidectomy and ventilation tube insertion for chronic otitis media with effusion (OME)
* Patients undergoing adenoidectomy alone for obstructive sleep disorder
* Patients undergoing adenoidectomy alone for chronic OME
* Patients undergoing adenoidectomy alone for chronic sinusitis

Exclusion Criteria:

* Patients not between 3-12 years old
* Patients with craniofacial anomalies
* Revision adenoidectomy
* Proven significant comorbidities
* Systemic diseases
* Bleeding diathesis
Long-Term Follow Up Study of Subjects Previously Administered HMI 102

An Open-Label, Long-Term Follow Up Study of Safety and Efficacy in PKU Subjects with PAH Deficiency Previously Administered HMI 102

This Long-Term Follow Up Study will evaluate the safety and efficacy of PKU Subjects with PAH Deficiency Previously Administered HMI 102. Subjects will have already received a single dose of HMI-102 administered intravenously

Eligibility Criteria:
Inclusion Criteria:

* Subject was previously administered HMI 102.
* Subject is able to understand the purpose and risks of the study and is willing to provide informed consent.
* Subject is able to comply with all study procedures and long-term follow-up.

Exclusion Criteria:

* Participation in the study is not in the subject's best interest, in the opinion of the Investigator.
Adverse Drug Reactions of Different Brands of Ceftazidime Injection

The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

Ceftazidime is a third generation cephalosporins that should be reserved for severe bacterial infections. Substitution of the brand ceftazidime with a generic ceftazidime raised some concerns.

The purpose of this study is to understand whether generic ceftazidime causes different adverse drug reaction incidence from the brand drug.

Eligibility Criteria:
Inclusion Criteria:

* patients in surgical intensive care unit who require ceftazidime treatment

Exclusion Criteria:

* less than 1 year old
Compare the Effectiveness of Sports Drink and Water as a Solvent in Polyethylene Glycol for Colonoscopy

In this study, 200 patients were enrolled from 2023.1.1 to 2023.12.31, and were randomly divided into intervention and control groups. The intervention group compared the effectiveness of intestinal preparation in the two groups with sports drinks as a polyethylene glycol solvent and water as a polyethylene glycol solvent in the intervention group, and compared adverse reactions, acceptability of solution taste, time of oral laxatives, willingness to repeat the same intestinal preparation or the willingness to recommend the same intestinal preparation to others.


Eligibility Criteria:
Inclusion Criteria:

Hospitalized patients with gastrointestinal disorders Age 18 to 25 years

Exclusion Criteria:

Those who refuse to drink sports drinks Hypersensitivity to polyethylene glycol pregnant women, patients with suspected intestinal obstruction patients at risk of aspiration or with severe systemic or poorly controlled chronic disease patients with acute or severe disease and coagulation disorders patients with diabetes mellitus patients with a history of abdominal surgery.
Nitric Oxide in Myocardial Infarction Size

The purpose of this study is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment elevation MI (STEMI) who undergo successful percutaneous coronary intervention.

The purpose of the trial is to assess whether or not inhaled nitric oxide can decrease myocardial infarction (MI) size as a fraction of left ventricular (LV) size at 48-72 hours in patients presenting with an ST segment elevation MI who undergo successful percutaneous coronary intervention (PCI).

The primary endpoint for this study will be myocardial infarction size as a fraction of left ventricular size at 48-72 hours as measured by contrast-enhanced cardiac MRI.

Eligibility Criteria:
Inclusion Criteria:

* Acute myocardial infarction and electrocardiographic evidence of ST elevation
* No clinical evidence of congestive heart failure
* All patients must undergo successful percutaneous coronary intervention for thrombolysis in myocardial infarction (TIMI) 0 or 1 coronary flow with resulting TIMI 2 or 3 flow
* Greater than 18 years of age
* Signed Institutional Review Board (IRB) approved informed consent

Exclusion Criteria:

* Prior myocardial infarction
* Requirement for urgent cardiac surgery
* Previous coronary artery bypass graft (CABG) or primary coronary intervention (PCI)
* Left bundle branch block
* Heart block that is expected to require a temporary pacemaker for greater than 72 hours
* Prior use of thrombolytic therapy for the current event
* Unable to tolerate magnetic resonance imaging or unable to tolerate gadolinium contrast media, including patients with a calculated creatinine clearance less than 60 ml/min/1.73m² Body Surface Area (BSA)
* Active or recent hemorrhage requiring an invasive procedure for evaluation or transfusion within 6 weeks prior to presentation, or hemorrhagic stroke within the 6 weeks prior
* Neutropenia (WBC \<2000 (mm)³), Anemia (HCT \<30%, Thrombocytopenia (Thrombocytes \<50,000 (mm)³). It is not necessary to confirm blood counts prior to start of study drug in the absence of clinical suspicion.
* Known or suspected aortic dissection.
* Prior history of pulmonary disease requiring chronic oxygen therapy.
* Pregnancy, lactating, and women of childbearing potential.
* Medical problem likely to preclude completion of the study.
* Use of investigational drugs or device within the 30 days prior to enrollment
The Combination of Sintilimab and AI (Doxorubicin, ADM/Ifosfamide, IFO) for the First Line Treatment of Select Type of Metastatic/Unresectable Soft Tissue Sarcoma

This is a phase II trial to explore the feasibility of PD-1 immune check point inhibitor, sintilimab, in combination of stand of care chemotherapy in first-line treatment of selected soft tissue sarcoma.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18-75 years;
* Provide written informed consent;
* Local advanced or metastatic unresectable sarcoma;
* Histologically confirmed undifferentiated pleomorphic sarcoma, synovial sarcoma, de-differentiated liposarcoma and myxoid liposarcoma;
* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale;
* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
* Life span expectation over 3 months
* Absolute neutrophil count (ANC) ≥1,500/mcL (within 7 days of treatment initiation) ；
* Hemoglobin ≥9 g/dL (within 7 days of treatment initiation) ；
* Platelets ≥ 90,000/mcL (within 7 days of treatment initiation) ；
* Serum creatinine ≤ 1.5 X upper limit of normal (ULN) or creatinine clearance \[CrCl\]) ≥ 50 mL/min for subject with creatinine levels (within 7 days of treatment initiation) ；
* Serum total bilirubin ≤ 1.5 X ULN (within 7 days of treatment initiation) ；
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 X ULN or =\< 5 X ULN for subjects with liver metastases (within 7 days of treatment initiation)；

Exclusion Criteria:

* Prior systemic therapy for advanced and metastatic disease, except adjuvant treatment（not received anthracycline）replase over 6 months;
* Received any testing anti-cancer drugs within four weeks of treatment initiation;
* Prior immune related therapy including but not limited to PD-1, PD-L1, CD137, CTLA4, T cell stimulation, check point inhibitor etc;
* Symptomatic, untreated, or uncontrolled brain metastases present
* clinical meaningful active bleeding;
* Other malignant cancer history rather than soft tissue sarcoma within five year prior to treatment initiation;
* Have active infections requiring therapy;
* Have active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study.
* Pregnant or breast-feeding；
* Any serious or unstable medical condition or mental illness；
* Serious systemic diseases such as heart disease, history of (non-infectious) pneumonitis;
* Active HBV （\>10000 copy/ml） and HCV （RNA\> 1000copy/ml） infection；
* Positive human immunodeficiency virus (HIV）or any acquired immunodeficiency syndrome, organ implantation;
This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Management Overnight in the Home Setting.

This post-market study will assess the performance of and user experience with the PureWick™ System in a home setting. The study will also observe safety of the study device and collect information from participants about their quality of life before and after using the device.

Approximately 150 women with nighttime urinary incontinence will take part in this prospective, open-label, randomized trial. Participants will use one of two different study devices during the study to manage urine output at night: PureWick™ System or the Hollister® Female Urinary Pouch External Collection Device. Participant device assignment will be random. Participants will use the assigned urine management device overnight while sleeping and will be followed for approximately 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Adult Female Participants greater than or equal to 18 years of age at the time of signing the informed consent.
2. Currently use diapers or equivalent at night for urine output management.
3. Willing to comply with all study procedures in this CIP.
4. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. Has frequent episodes of bowel incontinence without a fecal management system in place; or
2. Has moderate to heavy menstruation and cannot use a tampon or menstrual cup; or
3. Has urinary tract, vaginal or other chronic infections, active genital herpes; or
4. Has urinary retention; or
5. Is agitated, combative, and/or uncooperative and may remove the external catheter or pouch; or
6. Has any wound, open lesion or irritation on the genitalia, perineum, or sacrum; or
7. Has any pre-existing neurological, psychiatric, or other condition that would confound quality of life assessment or would make it difficult to self-report on quality-of-life questionnaires in the opinion of the investigator; or
8. Is known to be pregnant at time of enrollment (for women of childbearing age); or
9. Any other condition that, in the opinion of the investigator, would preclude them from participating in the study.
Liposomal Bupivacaine for Pain Control After Rotator Cuff Repair

The use of an interscalene block (ISB) is often associated with rebound pain that could be avoided through adjunctive therapy with longer duration. Administration of a liposomal bupivacaine (LB) field block in addition to ISB would overcome this rebound pain to provide greater pain relief and reduce opiate consumption when compared to ISB alone. 50 patients were recruited and randomized into groups that either received or did not receive an intraoperative LB field block in addition to standard ISB administration. Visual Analog Scale (VAS) pain scores and narcotic consumption were recorded over the five-day postoperative period to determine the effectiveness of LB pain relief.

Arthroscopic rotator cuff repair (ARCR) provides excellent clinical outcomes but is often associated with significant postoperative pain. As rotator cuff repair procedures become increasingly more common, these procedures and the narcotic prescriptions which accompany them may contribute to the rising opioid epidemic. The use of intraoperative local and regional anesthesia or field blocks, in conjunction with multimodal pharmacological strategies, is a widely accepted approach for managing surgical pain and reducing opiate use. The purpose of this study was to determine whether using a field block of liposomal bupivacaine (LB) in addition to an interscalene block (ISB) would provide greater pain relief and reduction in opiate consumption when compared to ISB alone.

The study enrolled 50 patients undergoing primary ARCR surgery. Patients were randomized to receiving intraoperative liposomal bupivacaine or not and provided with postoperative "Pain Journals" to document their daily pain on a visual analog scale (VAS) and to track their daily opioid consumption during the first five post-operative days.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* undergoing an arthroscopic rotator cuff repair surgery of a full thickness tear
* willing to fill out the "Pain Journal"; able to understand the informed consent process
* willing to document informed consent prior to completion of any study-related procedure
* able to read, comprehend, and complete subject-reported outcome measures in English

Exclusion Criteria:

* pregnant
* documented history of drug or alcohol abuse
* use of narcotic painkillers greater than 3 months prior to surgery
* neurologic deficit or disability involving the surgical extremity
* known allergy or intolerance to hydrocodone or oxycodone
* known allergy to amide anesthetics
* currently enrolled or planning to enroll in another clinical trial during this study that would affect the outcome of this study
* history of cognitive or mental health status that interferes with study participation