cyrilzakka/clinical-trials huggingface dataset:
Fenoldopam and Splanchnic Perfusion During Cardiopulmonary Bypass

Cardiopulmonary bypass (CPB) for cardiac operations may be accompanied by different patterns of visceral underperfusion. This could result in clinical patterns of lactic acidosis but in the most severe cases there is the risk for mesenteric infarction (0.2% of the cases). Renal function as well may be impaired due to a low oxygen delivery, and acute renal failure occurs in 1-2% of cases.

Fenoldopam mesilate is a selective splanchnic vasodilator when used at a dose \< 0.1 mcg/kg/min.

The experimental hypothesis of this randomized, controlled trial (RCT) is that the use of fenoldopam may determine a better visceral perfusion during CPB.

Randomized placebo-controlled double blinded study. Patients undergoing complex cardiac operations will be randomly allocated to the study or the control group.

All the patients will receive the standard of care of our Institution. Adequacy of CPB perfusion will be assessed using oxygen delivery calculation, lactate production, SvO2.

Eligibility Criteria:
Inclusion Criteria:

* Complex, combined cardiac operation
* Predicted CPB duration \> 90 minutes

Exclusion Criteria:

* Age \< 18 years
* No written informed consent
IM Neostigmine for Accelerating Bladder Emptying After CS by Spinal Anesthesia

The aim of this study is to assess the efficacy of IM neostigmine (0.5 mg) for acceleration of bladder evacuation and prevention of postoperative urine retention following cesarean delivery carried out under spinal anesthesia

Following cesarean delivery, women will receive either 0.5 mg IM neostigmine (study group) or IM NaCl 0.9% (control group). Bladder ultrasonography will be done every hour until spontaneous voiding occurs. If postoperative urine retention occurred (void inability with bladder volume \> 600 ml by ultrasound), urinary catheterization will be done.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women undergoing elective cesarean deliver under spinal anesthesia.

Exclusion Criteria:

* The age of the patient is more than 35 years of less than 20 years.
* The body mass index of the patient is more than 35 kg/m2 or her height is more than 180 cm or less than 150 cm.
* Multiple gestation.
* The patient is in active labor.
* Vaginal bleeding, placenta previa or abruption of the placenta.
* Presence of fetal distress.
* Urinary symptoms.
* Medical disorders co-existing with or complicating pregnancy.
* Contraindications for or history of adverse reaction of Neostigmine.
* Contraindication for spinal anesthesia.
* Refusal of the patient to receive spinal anesthesia.
* Intraoperative significant hemorrhage.
* Duration of the operation is more than one hour.
* Occurrence of postoperative complications as eclampsia.
Effect of Adiposity and Associated Local Microbial Factors on Healing and Progression of Diabetic Foot Ulcers

Diabetic foot ulcers (DFUs) and their associated complications like amputations are increasingly becoming a problem in low and middle income (LMI) countries. Obesity (increased body fat/adiposity), which has been shown to complicate many diseases, is also increasing in LMI setting. It is however not certain whether increased adiposity, may make it difficult for DFUs to heal. Investigators aim to understand whether increased adiposity and accompanied local microbial factors have any negative impact on healing and progression of DFUs.

A prospective cohort of 300 individuals with type 2 diabetes presenting with diabetic foot ulcers (DFUs) at an outpatient clinic will be recruited. At baseline, participants will be stratified into normal and high adiposity groups as measured by Bioelectrical Impedance Analysis (BIA). Both groups will receive DFU management according to locally appropriate standards of care and followed-up for 24 weeks or until complete wound healing, whichever occurs first. Local microbial characteristics, presence or absence of infection and other clinical parameters will also be assessed, and compared between the two groups. Enrolling 150 participants per group will have a minimum power of 80% to detect a 20% difference in cumulative incidence of complete ulcer healing (at the 5% level of statistical significance) between the normal and high adiposity groups.

Eligibility Criteria:
Inclusion Criteria:

* History of type 2 diabetes mellitus (T2DM)
* Presence of participant's signed informed consent
* Age 30 years and above at the time the participant is signing the consent
* Tanzanians of African origin (Black Tanzanians)
* Presence of diabetic foot ulcer (DFUs) (new or recurrent)

Exclusion Criteria:

* Known patients with congestive cardiac and/or renal failure.
* Any patients with absolute or relative contraindication for tissue biopsy (for incident cases)
* Patients with obvious signs of gangrene
* DFU patients with non-healing ulcer of more than 52 weeks duration.
* DFU patients with below normal body mass index BMI (BMI below 18).
Effectiveness of Two Self Assessment Tools: KIOS-Bipolar or eMoods

The goal of this project is to complete the development of a patient-centered software system and mobile app to assist in managing bipolar disorder. In Phase I, the investigators developed a novel computational tool known as KIOS. Based on concepts from nonlinear systems (chaos) theory, KIOS tracks multiple interacting symptoms to determine the precise state of a BD patient. Once the patient's state is identified and the trajectory of the patient is established, KIOS produces advice specific to the patient's condition to help manage the course of the disease. To demonstrate the usability of the software, KIOS was converted to an online tool with mobile access. Twenty bipolar patients evaluated KIOS in a twelve week field trial. No technical problems with the software were observed and results showed that patients had significantly more reductions in symptom severity than increases. The development of this innovative tool to help patients self- manage BD has the potential to have a profound impact on public health and achieve significant commercial success.

This Phase II study has the specific aim of evaluation of KIOS-Bipolar in a randomized, open 52 week effectiveness study of 120 bipolar subjects in current treatment at three socioeconomically diverse academic health science centers. Concurrent with this clinical effectiveness study, the research team, funded by the same NIH grant,will refine prototype software and integrate data security and establish quality standards into the KIOS-Bipolar system.

The clinical trial will:

Assess sensitivity of K-B assessed improvement or worsening by comparison with assessment by BISS-Self and BISS-42.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients 18 years of age or older
2. Bipolar I or II disorder as assessed by MINI 6.0
3. In psychiatric outpatient treatment at UTHSCSA, University of Louisville, or Lindner Center of Hope, Mason Ohio
4. Currently taking mood stabilizer or second generation antipsychotic for 4 weeks or longer
5. Ability to access Kios-Bipolar or eMoods (via computer, smartphone or tablet)

Exclusion Criteria:

1. Unwilling or unable to comply with study requirements
2. Renal impairment (serum creatinine \>1.5 mg/dl
3. If on thyroid medication must be euthyroid for at least 1 month
4. Drug/alcohol dependence within the past 30 days
Clinical Trial of the Combination of Trastuzumab (Herceptin) and Tanespimycin in Patients With Solid Tumors and Her2 Positive Metastatic Breast Cancer That Have Previously Failed Herceptin

The primary purpose(s) of this study is to determine the highest tolerated dose of tanespimycin and to determine anti-tumor activity (via objective response rate) of tanespimycin in patients with breast cancer who have not previously responded to Herceptin


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years
* KPS performance status \>= 70%
* For the Phase 1 portion of the trial, all patients must have a histologically confirmed solid tumor malignancy. For the Phase 2 portion of the trial, patients must have metastatic breast cancer with HER2 amplification by FISH or 3+ HER2 overexpression by immunohistochemistry ("IHC") Patients may have had either progressive disease within 3 months following last dose of adjuvant treatment with trastuzumab OR progressive disease following initial therapy for metastatic disease with trastuzumab (trastuzumab may have been administered with cytotoxic chemotherapy, hormonal therapy or as single agent.) Patients who have received trastuzumab single agent therapy (without documented progressive disease) followed by trastuzumab combination therapy remain eligible for this study at the time of disease progression. Patients must have measurable disease by RECIST
* All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to NCI CTCAE (v. 3.0) Grade \<= 2 (except for alopecia)
* The following laboratory results, within 10 days of KOS-953 administration:
* Hemoglobin \>= 8.5 g/dL
* Absolute neutrophils count \>= 1.5 x 10\*9\* /L
* Platelet count \>= 75 x 10\*9\* /L

  * Serum bilirubin \<= 2 x ULN
  * AST and ALT \<= 2 x ULN
  * Serum creatinine \<= 2 x ULN
  * Signed informed consent

Exclusion Criteria:

* Documented hypersensitivity reaction of CTCAE Grade \>= 3 to prior therapy containing Cremophor (for those patients who receive the Tanespimycin Injection only) or Herceptin
* Pregnant or breast-feeding women
* Known active CNS metastases
* Except for trastuzumab (Herceptin®) administered between 7-21 days prior to first tanespimycin (KOS-953) administration, administration of any other chemotherapy, biological, immunotherapy or investigational agent (therapeutic or diagnostic) within 14 days prior to receipt of study medication. Patients should be 6 weeks from last dose of nitrosourea
* Severe dyspnea at rest caused by complications of advanced malignancy or requiring supplementary oxygen therapy
* Congestive heart failure, or a left ventricular ejection fraction (LVEF) less than 50% assessed by multigated radionuclide angiography scan or echocardiography
* Any medical conditions that, in the Investigator's opinion, would impose excessive risk to the patient
* Patients with previous malignancies unless free of recurrence for at least 5 years except cured basal cell carcinoma of the skin, carcinoma-in-situ of either the uterine cervix or urinary bladder, or Stage T1 or T2 prostate cancer whose PSA is \< 2 ng/mL
Comparison of Two Different Doses of Azithromycin for Treatment of Yaws

The study will be a single blinded, randomized, controlled open label non-inferiority phase III, trial with two parallel groups, conducted in Ghana and Papua New Guinea (PNG). The ultimate goal is to establish if a 20mg/kg dose of azithromycin is as effective as a 30mg/kg dose in the treatment of yaws. Approximately 600 clinically and serologically diagnosed yaws patients will be included in the study. Patients will be randomized to receive treatment with the two antibiotic regimens as follow: (i) Regimen I (AZT20): Single oral dose of 20 mg/kg azithromycin (ii) Regimen II (AZT30): Single oral dose of 30 mg/kg azithromycin. The follow-up period of patients will be 6 months. Assessments before, during and after the antibiotic treatment will include full medical history, clinical assessment of the lesion and, laboratory investigations. The primary efficacy parameters are healing of the lesion at 4 weeks and a four-fold decline in RPR titre at 6 months after start of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 6 to 16 years
* Clinical lesion consistent with primary or secondary yaws -Primary ulcer or papilloma
* Dually-Positive Chembio DPP Syphilis Screen \& Confirm
* Informed Consent and Assent (for children 12-16 years)

Exclusion Criteria:

1. Known allergy to azithromycin or macrolides.
2. Treatment with long-acting penicillin or alternative antibiotic with activity against T. pallidum within the last 3 months (ceftriaxone, azithromycin or doxycycline, amoxicillin).
3. Patients with current treatment with any drugs likely to interact with the study medication.
4. Patients who are unable to take oral medication or having gastrointestinal disease likely to interfere with drug absorption.
5. Patients who may not be able to comply with the requirements of the study protocol including follow up visits.
6. Patients who are not willing to give informed consent (patient and/or parent/legal representative), or who withdraw consent.
Enhanced Primary Care and Technology for Children With Chronic Disease

Using technology alongside a pediatric chronic disease specialist and behavior specialist, the investigators are planning to help care for and coordinate the healthcare of children with chronic diseases, particularly childhood obesity, diabetes and asthma in Miami's most vulnerable communities. The University of (UM) Miller School of Medicine (MSOM) Pediatrics and TeleHealth departments propose to leverage information and communications technologies (ICT) in an innovative approach to improve the quality, access and efficiency of pediatric services for children and their families.

Participants will be recruited from an outpatient clinic site with diagnoses of overweight, obesity or asthma.

There will be a total of 6 visits during the study at approximately 1 month intervals. During the first and last visits, pre- and post-intervention assessment points, quality of life, adherence to medical regimen, physical activity and dietary habits will be gathered. During the follow-up visits, only quality of life will be surveyed. At the initial visit, for overweight children, the patients will be assessed for their behaviors and attitudes regarding eating, physical activity, sedentary time and motivation. If the patient has asthma, the pediatrician will assess understanding of the disease.

Throughout the course of the study the chronic condition pediatrician and behavior specialist will see patients in a consult capacity for their chronic condition, but the patient will continue to see their regular pediatrician for primary care needs. At every visit the pediatrician will review changes since the last visit, and then provide education directed at overweight/obesity and/or asthma. The behavior health specialists will then work with the patients to develop a plan on how to follow their treatment plan and achieve healthy behaviors.

All of the participants will receive access to technology in the form of a tablet computer for the duration of the study. The tablets will be installed with software to help educate patients and their families about asthma and overweight/obesity and track progress in managing them. In addition, all follow-up visits except for the final one will be done using the tablets and a video-conferencing app.

For the first and last visits, all patients will be seen in-person in the clinic. All of the follow-up visits will be done via a video-conferencing app on the tablet computers.

Eligibility Criteria:
Inclusion Criteria:

* Patients who receive care at the Borinquen Clinic
* Aged five through 18, inclusive
* Diagnosis of asthma (requiring medication) or overweight (greater than or equal to 85% for age).
* Fluent in English or Spanish.
* Parents/Guardians must be fluent in English or Spanish.

Exclusion Criteria:

* None.
Crux Biomedical Vena Cava Filter Study - United States

The purpose of this study is to determine if the Crux Vena Cava Filter System is safe and effective in preventing pulmonary embolism.


Eligibility Criteria:
Inclusion Criteria:

* Patient has a permanent or temporary risk of Pulmonary Embolism
* Patient or legal guardian must provide written informed consent
* At least one of the following conditions

  * Proven PE
  * Recurrent PE despite adequate anticoagulation
  * Contraindication to anticoagulation
  * Inability to achieve/maintain therapeutic anticoagulation
  * Iliocaval DVT
  * Large, free-floating proximal DVT
  * Massive PE treated with thrombolysis/thrombectomy
  * Chronic PE treated with thrombectomy
  * Procetion during thrombolysis for iliocaval DVT
  * PE with limited cardiopulmonary reserve
  * Poor compliance with anticoagulation medication
  * High risk of injury worsend by anticoagulation
  * Multi-trauma patient with high risk of PE
  * Surgical patients at high risk of PE
  * Medical condition with high risk of PE
* Patient has documented vena cava diameter of 17-28mm
* Patient has IVC anatomy suitable for infra-renal placement
* Patient willing to be available for the appropriate follow up.

Exclusion Criteria:

* Age \<18 years old
* Patient has any one of the following conditions

  * Renal vein thrombosis
  * IVC thrombosis extending to te renal veins
  * Duplicate IVC
  * Gonadal vein thrombosis
  * Requires supra-renal placement
* Uncontrolled infectious disease
* Risk of aseptic PE
* Uncontrolled coagulopathy
* Existing inferior vena cava filter implant
* Life expectancy less than 6 months
* Pregnant or planning a pregnancy in the next 6 months
* Condition that inhibits radiographic visualization of the IVC
* Known allergy or intolerance to polytetrafluoroethylene (PTFE) or Nitinol
* Known hypersensitivity to contract which cannot be pretreated
* Access vessels preclude safe insertion of delivery system
* Participation in another drug or device trial
* Unable or unwilling to cooperate with study procedures or required follow-up visits
Helping HAND: Healing Anorexia Nervosa Digitally

The proposed project will develop and pilot a coached mobile app, including a social networking component, for individuals with anorexia nervosa to use in the post-acute period

Anorexia nervosa (AN) is a costly and life-threatening illness. Patients with severe AN are often treated in the acute setting, but relapse after treatment is common. Further, the discharge criterion in acute settings is typically weight restoration. However, research has indicated that weight-based recovery is not "enough" and that full recovery involves physical, behavioral, and psychological components. Cognitive-behavioral therapy (CBT) is useful with this population, including following discharge, and may aid in addressing psychological symptoms, achieving full recovery, and decreasing relapse. However, very few patients have access to providers trained in these techniques. mHealth technologies have great potential to exponentially increase access to high-quality services for the post-acute treatment of AN by addressing barriers to treatment, but to date, research on these approaches has been extremely limited. A guided self-help CBT-based mobile app, StudentBodies-Eating Disorders (SB-ED), has been successfully developed, demonstrating effectiveness among college women with binge/purge-type EDs. At the same time, there is demonstrated support for in-person CBT for the post-acute care and relapse prevention of adult AN. The overarching goal of this R34 is thus to develop and test a CBT-based, coached mobile app to address the post-acute care and relapse prevention.

Eligibility Criteria:
Inclusion Criteria:

* Cisgender women who are 18 years old and older, who own a mobile phone, speak English, are U.S. residents, have a BMI greater than or equal to 17, who are connected with a physician (such as a primary care provider), who are not using a feeding tube, and who have been discharged from intensive treatment (i.e., inpatient, residential, partial hospitalization, intensive outpatient) for DSM-5 anorexia nervosa within the past 2 months.

Exclusion Criteria:

* Individuals who are not cisgender women.
* Individuals under 18 years old.
* Individuals who do not own a mobile phone.
* Individuals who have not been discharged from intensive treatment (i.e., inpatient, residential, partial hospitalization, intensive outpatient) for DSM-5 anorexia nervosa within the past 2 months).
* Individuals who are not connected with a physician (such as a primary care provider)
* Individuals who have a BMI below 17.0
* Individuals who are currently using a feeding tube
Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)

The purpose of this study is to determine the incidence of contrast induced nephropathy and myocardial tissue reperfusion following iso-osmolar iodixanol or ipo-osmolar iopromide administration in patients with acute myocardial infarction undergoing primary PCI.

This is a multicentric randomized comparison between iso-osmolar and ipo-osmolar contrast agents in patients treated with primary PCI with the evaluation of contrast-induced nephropathy incidence and myocardial tissue reperfusion. The study was designed as a non-inferiority trial.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged ≥ 18
* Patients with ST-elevation Myocardial Infarction presenting within 12 hours after the onset of symptoms (18 hours in case of cardiogenic shock), who are scheduled to undergo primary PCI
* Patients who have signed and dated the written informed consent form

Exclusion Criteria:

* Patients in pregnancy or lactation
* Long-term dialysis
* Administration of any investigational drug within the previous 30 days
* Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
* Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
* Contraindications to the study drug or the cardiac catheterization procedure
* Previous participation in this study
* As the discretion of the investigator, the patient has any conditions not appropriate to the usage of iodinated contrast agent or not appropriate to undergo cardiac catheterization procedure
Safety and Feasibility of a Novel Device for Assessing Respiratory Function in Children

This is an early phase pilot study designed to test the safety and feasibility of using a novel, wireless, wearable device (Leo) for assessing respiratory parameters (lung volume, respiration rate, heart rate and indices related to tidal breathing flow volume loop) in children with respiratory condition (such as asthma).

There is no product currently on the market that is comparable to this novel Leo device

The study consists of a single visit to evaluate the feasibility and safety of using the Leo device on 20 children with clinically stable asthma.

Stable asthmatic children between the age of 3 and 6, inclusive, will be recruited.

There will be no disease-specific intervention, nor changes to the participant's care management program for their asthma.


Eligibility Criteria:
Inclusion Criteria:

* Children aged ≥3 years old and ≤18 years old at time of consent
* Children with a legal guardian able to sign consent for study participation
* Children and caregivers able to read and understand English or Spanish
* Investigator confirmation for diagnosis of clinically stable respiratory condition, such as clinically diagnosed asthma
* Children who are able to follow instructions and complete oscillometry and tidal breathing tasks

Exclusion Criteria:

* - Children \<3 and \>18 years of age
* Adults (age ≥ 18 years)
* Children with complex medical conditions which may hinder their ability to complete protocol assessments
* Children who do not have a legal guardian to sign informed consent form
* Children with an active skin condition involving the area on the chest wall where the Leo device will be attached. E.g. inflamed and/or infected eczema or other skin conditions involving the anterior chest wall at the time of recruitment
* Child is determined not eligible by the assessment of the PI
* Fever within the 4 weeks prior to enrollment
* Children with any implanted medical devices, E.g. cardiac pacemaker
* Children with any history of known allergic reaction to adhesives or hydrogels, as the ones used with the Leo device
* Children who have taken a bronchodilator in the last 8-24 hours prior to study visit, depending on the type of medication.