cyrilzakka/clinical-trials huggingface dataset:
Dexmedetomidine in Reducing Incidence of Emergence Agitation After Nasal Surgery

Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.

Emergence agitation (EA) or delirium is a post anesthesia complication which is manifested as confusion, agitation, disorientation and aggressive behavior. It can lead to serious consequences including hemorrhage, removal of lines, drains and catheters, self-extubation and even falling out of bed resulting in severe injuries. EA is associated with cognitive deficit, physical dependence, increased hospital stay and higher mortality.

There is wide variation in the incidence of EA in scientific literature ranging from 5 % to 27.3 %. There are no clear diagnostic criteria for EA because of its varied clinical manifestations. Although many risk factors have been identified including pain, presence of stress at the time of induction, induction with etomidate, use of premedication with benzodiazepines, hypoxemia, type of surgery, awakening in hostile and noisy environment and presence of urinary catheter. Patients undergoing nasal surgeries are in particular, at higher risk for EA due to a sense of suffocation secondary to nasal packing.

Various pharmacological interventions have been attempted previously to prevent postoperative EA with variable results. These include use of opioids, propofol, midazolam, ketamine, magnesium and alpha-2 agonists like clonidine and dexmedetomidine. Dexmedetomidine have been used with different dosages and different timings of administration with variable results and at the expense of major hemodynamic disturbances. The objective of this study was to investigate the role of single dose of dexmedetomidine (0.5 mcg/kg) administered as 30 minutes infusion prior to extubation in reducing the incidence and severity of EA and coughing on extubation.

Eligibility Criteria:
Inclusion Criteria:

* We will include patients aged 15 years to 65 years, ASA 1-3 who are planned to undergo general anesthesia for elective nasal surgeries in which nasal packing is used postoperatively

Exclusion Criteria:

* We will exclude patients with known allergy to study medications, BMI more than 35, history of obstructive sleep apnea, history of psychiatric illness, pregnancy and presence of liver and renal diseases.
Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction

Patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block. Post-operative pain, nausea/vomiting scores will be assessed.

Patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block after induction of general anesthesia and prior to the start of surgery. Post-operative pain scores and post-operative pain medication usage will be recorded. Post-operative nausea/vomiting scores and post-op anti-emetic medication usage will be recorded. The clinical impact of pectoral nerve block on this expanding population of patients will be determined.

Eligibility Criteria:
Inclusion Criteria:

1. Patients age 18-90 years old
2. Subjects able to read and understand the informed consent
3. American Society of Anesthesiologists (ASA) physical status I and II
4. Subjects scheduled to undergo unilateral or bilateral mastectomy with immediate breast reconstruction with submuscular placement of tissue expander or permanent implant under general anesthesia, including:

   * subjects diagnosed with breast cancer
   * subjects diagnosed with atypia or other high risk proliferative breast disease
   * subjects with a family history who are considered at high risk for breast cancer (including those with hereditary or genetic predisposition)

Exclusion Criteria:

1. Subjects unable to read or understand the informed consent
2. ASA physical status III or IV
3. Subjects with an allergy to local anesthetic
4. Subjects with a medical contraindication to regional anesthetic, such as coagulopathy or local infection
5. Subjects with a pre-existing submuscular implant
6. Subjects scheduled to undergo mastectomy with myocutaneous flap reconstruction
7. Subjects scheduled to undergo mastectomy without immediate reconstruction
8. Subjects with a history of chronic pain or chronic opioid use
Impact of a Virtual Diabetes Self-Care and Education Program on Diabetes-related Outcomes in Latinos With T2 Diabetes

The goal of this study is to evaluate the impact of a comprehensive diabetes education and management program based on frequent communication with patients using teleconsultation, text messaging, and phone calls on diabetes related outcomes in Latino patients with type 2 diabetes. The investigators hypothesize that the decline in hemoglobin A1c value between the baseline and the six-month visit will be at least 0.5 percent greater in the intervention group than in the control group.

In this study participants will be followed for a period of 9 months. The control group will receive usual care during this period of time. While, the intervention group will be part of a diabetes education and management program lasting 6 months via a smartphone participants will receive. The 6 month intervention will be followed by a 3 month observation period.

Eligibility Criteria:
Inclusion Criteria:

* Have physician-diagnosed type 2 diabetes
* Be self-identified as Hispanic or Latino
* An A1c value between 8-14% within the last three months.
* Demonstrate the ability, either alone or with the help of a family member that will be with the patient at least once a week, to use the technology that will be used during the teleconsultations

Exclusion Criteria:

* Severe diabetes related chronic complications such as chronic renal failure, blindness, amputations, stroke, etc.
* Concomitant chronic illnesses that would affect their participation in the program, i.e. cancer, debilitating diseases, etc.
* Any other condition that would affect participant's basic mental health skills
* Type 1 diabetes or gestational diabetes
* Patients with abnormal hemoglobin, anemia or any condition that may affect red blood cell turnover. Any of these conditions may be detected through participants' history or through the laboratory report at study screening
* Signs or symptoms of metabolic decompensation (polyuria, polydypsia, polyphagia, unexplained weight loss, blurry vision, lethargy, etc.)
Pain Relief for Submucosal Resection of Nasal Septum in Adults Does Ketamine Have a Pre-Emptive Effect?

Pain is an unpleasant sensory experience associated with actual or potential tissue damage. Acute pain management is an important aspect of perioperative anesthetic care. Moreover, it is the most important factor related to patient discomfort after surgery. Adequate pain management, ideally resulting in the complete absence of postoperative pain, not only provides comfort to patients, but may also contribute to improved healing and a reduction in the incidence of postoperative complications. Inadequate postoperative analgesia has been shown to contribute to adverse outcomes, including, but not limited to, immunosuppression, hyperglycemia, poor rehabilitation, and progression to chronic pain.

Patients who are scheduled for submucosal resection of nasal septum with or without turbinectomy will be recruited for the study The patients will be will be assigned to either the treatment group who will be administered ketamine prior to the operation or the control group who will receive a normal saline injection, both in identicle syringes.

All patients will be operated on by the same surgoens and by the same method of dissection and hemostasis (2-5 2 ml lidocadrain carpules, monopolar suction-cautery set on 25).

Patients folow-up will be reported in their medical charts. The post operative analgetic effect will be assessed by the amount of analgesia required in the post-operative period and by regular pain measurements using VAS (Visual Analogue Scale) - at 0.5 hours post operation in the recovery room, 8 hours post operation and the morning of first post operative day in the otolaryngology - head and neck department

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing submucosal resection of nasal septum with or without turbinectomy.
* Over 18 years of age.
* ASA (anesthsiology Severity Score) score of 1-2.
* Signed informed consent by patient or caregiver.

Exclusion Criteria:

* Allergy to Ketamine
* Unable/ unwilling to comply with the protocol requirements
* Pregnancy or breast feeding
* Chronic use of analgetics
* History of alcohol and/or drug abuse
* Previous nasal surgry
Responsiveness and Validation Study of MFM-20 in SMA Patients Treated With Nusinersen

The Motor Function Measure (MFM), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in France in many teams. It can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. Two versions of the MFM exist, one composed of 32 items validated for patients from 6 years old (MFM-32) and a shorter version composed of 20 items validated for patients between 2 and 6 years old (MFM-20).

In order to show the possible use of MFM-20 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with Nusinersen, we propose in this project to study the sensitivity to treatment-induced change of MFM-20 and the validity of the scale in this population.


Eligibility Criteria:
Inclusion Criteria:

* Boys and girls with Type 1 or 2 Spinal Muscular Atrophy, genetically confirmed
* Aged 2 to 6 years old
* Treated by Nusinersen for at least two months
* With at least 3 MFM-20 repeated measures, and with adelay minimum between the first and the last MFM-20 of 6 months
* With parental assent

Exclusion Criteria:

* - Patients with associated cognitive impairment making impossible evaluation of motor function
* Patients participating to a clinical study with a potential effect on their motor function.
Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping

Anthracyclines (e.g. Doxorubicin) are an important and highly effective chemotherapeutic. They are used in various tumor entities and are established for breast cancer treatment. The most significant prognostic side effect is cardiotoxicity, which occurs in up to 50 patients. Female gender must be considered an independent risk factor for the incidence and severity of associated heart failure. The aim of this study is to demonstrate that dose-dependent anthracycline-induced cardiotoxicity has a measurable effect on T2 mapping on MRI. The second aim is to demonstrate if the combination of diastolic strain (echo and MRI) and T2 mapping can detect earlier anthracycline-induced myocardial damage than via the established method of the echocardiographic measurement of LV-EF and the conventional quantification of diastolic function.

In order to answer the question, patients with breast cancer, who will undergo a chemotherapeutic treatment with antracycline, will be examined before chemotherapy (including cmr and echocardiography) and after chemotherapy at different times within one year.

Eligibility Criteria:
Inclusion Criteria:

* Planned therapy with an anthracycline and at least 1 year follow up
* \>18 years of age
* written informed consent

Exclusion Criteria:

* prior cardiovascular disease
* diabetes mellitus
* previous therapy with anthracyclines
Phase II Study of IL-11 (Neumega) in Von Willebrand Disease

This study is testing the use of rhIL-11 (recombinant interleukin 11, Neumega) in individuals with Von Willebrand disease. The purpose is to evaluate:

1. if rhIL-11 corrects VWF (Von Willebrand Factor) levels to normal
2. if rhIL-11 and DDAVP together will boost VWF levels even higher
3. the onset, peak, and duration of rhIL-11 effect
4. if rhIL-11 is safe in individuals with Von Willebrand Disease

This is a prospective, single center, open-label, escalating dose Phase II comparison study of interleukin-11 (rhIL-11, Neumega) in subjects with type 1 Von Willebrand Disease (VWD).

The purpose is to establish the clinical safety and hemostatic efficacy of rhIL-11 in individuals with type 1 Von Willebrand disease.

Study subjects will include the following subjects:

1. age \>= 18 years of age
2. diagnosis of VWD confirmed by: 2a) at least 2 of 4 abnormal vWD-related coagulation tests; 2b) a past bleeding history

A total of 10-16 subjects are anticipated to be enrolled and complete the study. The specific aims of the study are:

1. to compare the hemostatic efficacy of three escalating doses of rhIL-11
2. to determine the biologic effects of rhIL-11
3. to determine whether DDAVP, when given after the seventh daily dose of rhIL-11, enhances hemostatic efficacy or rhIL-11
4. to compare the safety of three escalating doses of rhIL-11

Efficacy will be based on the number and percent increase of VWD-related coagulation tests into the normal range, or at least to 2-3 times baseline.

Safety will be based on the number and frequency of adverse reactions, including fever, headache, fatigue, arthralgias, myalgias, fluid retention, and edema.

The study will last up to 4 weeks per subject, and for 24 months for the entire study.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years of age or older
* Confirmed VWD by 2 of 4 VWD coagulation tests abnormal
* A past bleeding history
* No hormone, oral contraceptive, estrogen use in past 8 weeks
* Willingness to have blood drawn
* Willingness to sign informed consent

Exclusion Criteria:

* Presence of other bleeding disorder, e.g. acquired VWD, thrombocytopenia
* Use of estrogens, hormones, oral contraceptives in past 8 weeks
* Use of immunomodulatory or experimental drugs or diuretics
* Pregnant or lactating women
* Past cardiac disease, congestive failure, arrhythmia (e.g. atrial fibrillation, atrial flutter), hypertension, MI, stroke, or thrombosis
* Past allergic reaction to Neumega or DDAVP
* Surgery within the past 8 weeks
* Inability to comply with study protocol requirements
* Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin, or NSAIDs
* Treatment with DDAVP, cryoprecipitate, whole blood, plasma, and plasma derivatives containing FVIII, VWF within 5 days of study
Spermatogonial Differentiation Via Testicular Organoid

Purpose:

This clinical trial aims to explore the potential for human sperm production in vitro by sustaining a laboratory-cultured adult testicular environment. It also seeks to identify genetic factors contributing to human sterility and failed spermatogenesis. The study's primary objectives include:

1. Identifying genomic markers associated with sterility and failed spermatogenesis.
2. Developing an ex vivo (outside the body) testis "organ-on-a-chip" ("iTestis") to support stem cell cultivation.
3. Determining whether human spermatogenesis can be re-created in vitro using stem cells nurtured in the iTestis model.

Study Description:

Researchers will analyze the genomic profiles of fertile and sterile male participants to map genetic abnormalities associated with sterility. Using testicular and skin tissue samples from participants, spermatogonial stem cells and pluripotent stem cells will be isolated and utilized to construct the ex vivo iTestis. This system will integrate genomic insights and prior research to foster human spermatogenesis outside the body.

Participant Involvement:

Participants will provide the following samples:

* Blood sample for serum analysis.
* A skin tissue biopsy.
* Testicular tissue, obtained through fine needle aspiration (FNA) or testicular sperm extraction (TESE), as part of a routine procedure.

All procedures will be conducted by the principal investigator and qualified research staff, ensuring participant safety and adherence to ethical guidelines.


Eligibility Criteria:
Inclusion Criteria: Group 1 (Fertile Control)

* Male sex of reproductive age (between 18 - 60 years old).
* Evidence of fertility or normal spermatogenesis.
* Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.

Inclusion Criteria: Group 2 and 3 (Infertile)

* Male sex of reproductive age (between 18 - 60 years old).
* Males with evidence of \>1 year of infertility.
* Posesses diagnosis of azoospermia is on clinical evaluation.
* Will undergo study procedures in conjunction with their planned fertility or infertility procedures performed for clinical purposes.

Exclusion Criteria:

- The lack of diagnosis of fertility or infertility, and lack of testicles.
Implantable Cardioverter Defibrillator (ICD) Function During Ventricular Assist Device (VAD) Implantation

The purpose of this research study is to test the function of a subjects implantable cardioverter defibrillator (ICD) function throughout the duration of their heart surgery. ICD function can be altered during some types of heart surgery such as those when a pump (ventricular assist device - VAD) is implanted. The investigators would like to study the mechanism of device and ICD malfunction.

ICD function is typically measured prior to and after surgery. For the study, the investigators will measure ICD lead function multiple times throughout the surgery as well, to determine if and when device malfunction occurs. ICD lead function is measured noninvasively through a specialized computer the same way it is checked in the clinic. In addition, the investigators will test ICD function as they usually do following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients ages 18 and older
* Have a wireless implantable cardioverter defibrillator (ICD) and are undergoing VAD implantation or other cardiothoracic surgery.

Exclusion Criteria:

* Patients who are pacemaker dependent
* children, human fetuses, neonates
* prisoners will not be included
* Pregnant women will not be included
Open Study of CEP-701 in Patients With Refractory Acute Myeloid Leukemia With FLT-3 Mutation

The purpose of this study is to determine the response rate of patients with refractory, relapsed or poor risk AML expressing FLT-3 activating mutations, when administered CEP-701 at a dosage of 60 mg 2 times a day.

This is an open-label study of CEP-701 in patients with refractory, relapsed, or poor risk AML expressing FLT-3 activating mutations. Patients who meet eligibility criteria will be enrolled at a dosage of 60 mg orally 2 times a day for 28 days (1 cycle). Upon completion of cycle 1, the dosage may be increased to 80mg 2 times a day or decreased to 40 mg 2 times a day, dependent upon response to 60 mg dosage.

Eligibility Criteria:
INCLUSION CRITERIA:

* patient must have confirmed diagnosis of refractory or relapsed AML that expresses a FLT-3 mutation
* patient must have life expectancy of more than 2 months
* patient must be fully recovered from reversible side effects of previous therapy for cancer

EXCLUSION CRITERIA:

* total bilirubin, ALT or AST greater than 2 times upper limit of normal
* patient \<65 years of age with estimated creatinine clearance less than 60 mL/min; patient \>65 years of age with serum creatinine \> 1.5 times the upper limit of normal (ULN)
* received any investigational drug within past 4 weeks
* GI disturbance/malabsorption that may affect absorption of CEP-701
* HIV positive
* received NSAID within prior 14 days
* has active infection
The Comparision of Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer

Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open pancreatoduodenectomy for short-term outcomes and long-term follow-up in a randomized trial.

This study is to compare the efficiency and safety between minimally invasive (including laparoscopic and robotic) and open pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to minimally-invasive or open group before the operation day. The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate as well as disease free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Age: \>18yr, \<75yr
* Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy
* Preoperative imaging assessment is resectable or borderline resectable

Exclusion Criteria:

* Benign tumors of the head of pancreas
* Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis.
* conversion to laparotomy because of intraoperative difficulty
Refitting Frequent Replacement Lens Wearers Into Clariti 1 Day And 1-Day Acuvue Moist Daily Disposable Spherical Lenses

The objective of the study is to evaluate and compare the performance of somofilcon A to etafilcon A when worn on a daily disposable wear modality over a period of approximately one week.

The study is a prospective, double masked (investigator and participant), bilateral, randomized, cross-over dispensing study, which evaluates somofilcon A (test lens) and etafilcon A (control lens).

Eligibility Criteria:
Inclusion Criteria:

* Subjects will only be eligible for the study if:

  1. Is at least 17 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. Habitually wears silicone hydrogel frequent replacement soft contact lenses, for minimum of 6-months;
  5. Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
  6. Can be fit with study contact lenses with a power between - 0.50 and -10.00 DS;
  7. Demonstrates an acceptable fit with the study lenses;
  8. Habitually wears contact lenses for at least 8 hours per day, and willing to wear contact lenses for at least 12 hours a day in the study.

     Exclusion Criteria:
* Subjects will not be eligible to take part in the study if:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known active\* ocular disease and/or infection;
  3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation at the screening visit);
  7. Is aphakic;
  8. Has undergone refractive error surgery;
  9. Is an employee of the Centre for Ocular Research \& Education;
  10. Has participated in the BEAGLE (EX-MKTG-104) study.