cyrilzakka/clinical-trials huggingface dataset:
Novel Therapies for Metabolic Complications of Lipodystrophies

Lipodystrophies represent a therapeutic challenge with regards to the management of the diabetes, insulin resistance, hypertriglyceridemia and fatty liver which frequently present in conjunction with significant adipose tissue loss. The purpose of the study and it's four subprojects is to examine the safety and efficacy of various novel interventions designed to improve or resolve the fatty liver, hypertriglyceridemia, and insulin resistance or diabetes that is seen in these patients.

We propose novel therapeutic approaches for the management of metabolic complications in patients with lipodystrophies. The four interventions to be tested are:

Hypothesis 1: An extremely low fat diet.

Eligibility Criteria:
Inclusion Criteria:

General Inclusion criteria:

* Patients with lipodystrophies as diagnosed by clinical criteria
* Any one of the following:

  * Diabetes mellitus, or
  * Fasting serum triglycerides greater than 200 mg/dL, or
  * Fasting serum insulin greater than 30 U/mL, or
  * Hepatic steatosis ( greater than 5.6% hepatic triglyceride content) as demonstrated by 1H MRS.

Exclusion Criteria:

* Known liver disease due to causes other than non-alcoholic steatohepatitis:
* Current alcohol abuse (more than 7 drinks or 210 g per wk for women and more than 14 drinks or 420 g per wk for men).
* Positive serological markers of hepatitis B and C.
* Autoimmune hepatitis, autoimmune cholestatic liver disorders, Wilson disease and Alpha-1-antitrypsin deficiency as indicated by clinical and laboratory tests.
* Drug-induced liver disease
* Evidence of hepatocellular carcinoma: alpha-fetoprotein levels greater than 200 ng/ml and/or liver mass on imaging study suggestive of liver cancer.
* Decompensated liver disease as evidenced by clinical features of hepatic failure (variceal bleeding, ascites, hepatic encephalopathy etc.) and laboratory investigations (prolonged prothrombin time, hypoalbuminemia, presence of esophageal varices etc.)
* Use of the drugs which can potentially decrease hepatic steatosis during previous 3 months; high-dose vitamin E, betaine, acetylcysteine, choline and probucol.
* Significant systemic or major illnesses other than liver disease (congestive heart failure, unstable angina, cerebrovascular disease, respiratory failure, renal failure \[serum creatinine more then 2 mg/dL\], acute pancreatitis, organ transplantation, serious psychiatric disease, and malignancy) that could interfere with the trial and adequate follow up.
* Acute medical illnesses precluding participation in the studies.
* Known HIV infected patient.
* Current substance abuse.
* Pregnant or lactating women.
* Hematocrit of less than 30%.
* History of weight loss ( more than 10%) or use of weight loss drugs such as sibutramine or orlistat in the last 3 months.

Each subproject has additional specific inclusion and exclusion criteria
A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)

This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients 60-75 years of age;
* B-cell follicular NHL;
* no previous treatment;
* active disease, with rapid progression.

Exclusion Criteria:

* other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
* long-term use (\>1 month) of systemic corticosteroids;
* central nervous system involvement;
* history of significant cardiovascular disease;
* positive test result for HIV, or hepatitis B or C.
Cancer of the Uterus and Treatment of Stress Urinary Incontinence

Concurrent treatment of endometrial cancer and SUI may improve QOL, emotional and physical health and decrease costs for both patients and the health care system. At the time of endometrial cancer diagnosis, not only are women evaluated by a gynecologist and/or a gynecologic oncologist, but the majority will undergo surgery within weeks of their diagnosis. Thus, urinary incontinence could easily be identified, a referral made, and concurrent surgery performed. This would spare the patient two surgeries, decrease the emotional distress associated with SUI symptoms, decrease the costs associated with SUI for the patient and possibly improve overall quality of life. The proposed study will compare the quality of life and clinical outcomes among women with endometrial cancer and SUI that have concurrent surgery to women that do not have concurrent surgery. The findings of our proposed research will provide valuable information necessary for woman and clinicians to make decisions regarding the treatment of SUI, including evidence regarding the risks and benefits of performing concurrent endometrial cancer and SUI surgery.


Eligibility Criteria:
Inclusion Criteria:

* Women will be eligible if they have:

  1. clinical stage 1 or 2 (disease confined to the uterus) endometrial carcinoma or complex atypical hyperplasia
  2. answer yes to one screening question: "Do you ever leak urine when you cough, sneeze, jump or laugh?" We will include women with complex atypical hyperplasia (CAH) because 40% of these women will have an endometrial cancer identified at the time of surgery and the risk factors are the same for CAH as they are for clinical stage 1 and 2 endometrial cancers

Exclusion Criteria:

* Women will be excluded if they have

  1. clinical stage 3 and 4 endometrial cancer
  2. prior pelvic radiation therapy
  3. vesicovaginal fistula
  4. urethrovaginal fistula.
* We are excluding women with vesicovaginal fistula or urethrovaginal fistula due to the risk of infection when placing a midurethral sling.
Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics

The purpose of this study is to evaluate the efficacy and safety of VI-0521 compared to placebo in the glycemic management of obese diabetic adults.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Type 2 Diabetes
* BMI 27-42
* Specified diet/exercise and/or diabetes medications

Exclusion Criteria:

* BP \> 150/95
* Stroke/MI/unstable cardiovascular disease within 6 months
* Clinically significant renal, hepatic, or psychiatric disease
* Unstable thyroid disease or replacement therapy
* Nephrolithiasis
* Obesity of known genetic or endocrine origin
* Participation in a formal weight loss program or lifestyle intervention
* History of glaucoma
* Pregnancy or breastfeeding
* Alcohol abuse
* Eating disorder
* Excluded medications
Stage 3 Fontan Operation Liver Ultrasound Study

The purpose of this study is to compare the liver stiffness, which can be caused by congestion and fibrosis in pediatric patients before and after a Fontan heart operation.

A new form of ultrasound elastography (Acoustic Radiation Force Impulse, or ARFI) will measure liver stiffness.

The Fontan repair for single ventricle congenital heart lesions consists of three stages. This surgery has enable pediatric patients who have the repair to live into adulthood.

Stage 3 of the surgery introduces immediate congestion of blood in the liver by increasing central venous pressure (CVP). CVP is the blood pressure within the vena cava, a major blood vessel in the body.

Many patients later develop progressive liver fibrosis (stiffness) possibly as a result of increased blood pressure. Liver stiffness is increased both by congestion and fibrosis.

Liver fibrosis has significant health risks and may complicate the patient's future healthcare.

There are no established, noninvasive means of detecting the liver fibrosis until it becomes severe. Acoustic radiation force impulse (ARFI) elastography, an ultrasound technique, can measure the stiffness of the liver safely from outside the body.

The investigators hypothesize that liver stiffness will be increased by stage 3 of the Fontan operation due to onset of liver congestion.

Using ARFI, the investigators will measure liver stiffness before and immediately after stage 3 of the Fontan operation, when congestion of blood is likely the only contributor to any change in liver stiffness.

The investigators will follow the trend of liver stiffness at six months by repeating the ARFI imaging.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients ages 0-17
* Patients presenting to the University of Michigan for evaluation just before undergoing stage 3 of the Fontan operation

Exclusion Criteria:

* Patients over the age of 17
* Patients who have chronic liver disease (elevation of ALT, AST, or Bilirubin greater than two times the upper limits of normal \>4 weeks)
* Patients who have evidence of liver enlargement or nodularity on prior ultrasound imaging
* Patients who have a history of portal vein or hepatic vein thrombosis
* Patients (parents) who are unwilling to read and sign the informed consent document
DuoCor Ventricular Assist System Early Feasibility Study

Feasibility study of the DuoCor Ventricular Assist System as a treatment for advanced total heart failure patients.


Eligibility Criteria:
Inclusion Criteria:

1. Requiring a biventricular mechanical circulatory support, defined by either of the following criteria:

   * Persistent total heart failure despite under optimal medical management based on current heart failure practice guidelines. OR
   * Development of refractory right heart failure following left ventricular assist device (LVAD) implantation, unresponsive to pharmacological interventions for right heart failure.
2. Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.

Exclusion Criteria:

1. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patient's health status.
2. Technical obstacles which pose the implantation as unsuitable, obtaining the body type, body surface area, and anatomical conditions related to the planned implantation site, in the judgment of the experienced investigators.
3. Pregnancy.
4. Age \> 75 years.
5. Presence of an active, uncontrolled infection.
6. Brain death.
7. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter.
8. Irreversible cognitive dysfunction, psychosocial issues, or psychiatric disease, likely to impair compliance with the study protocol and DuoCor VAS management which, in the opinion of the investigator, could interfere with the ability to manage the therapy.
Type VI Secretion System in Klebsiella Pneumoniae

Klebsiella pneumoniae (K. pneumoniae) is an important opportunistic pathogen contributing to nosocomial and antimicrobial-resistant infections. The increasing prevalence of infections caused by multidrug-resistant K. pneumoniae has emerged as a major clinical and public health threat, while the serous organ and life-threatening infections caused by highly virulent K. pneumoniae have also emerged( Russo and Marr, 2019; Wyres et al., 2020).

Both drug-resistant and highly virulent K. pneumoniae have brought major challenges to clinical treatment and stimulated interest in studying K. pneumoniae. However, knowledge of the genomics, ecology, and pathogenicity of K. pneumoniae is relatively limited. Recently, the type VI secretion system (T6SS) was identified as a virulence factor in K. pneumoniae (Martin and Bachman, 2018). Furthermore, K. pneumoniae was found to exploit the T6SS nano-weapon to destroy bacterial competitors and fungi (Storey et al., 2020).

The bacterial Type VI Secretion System (T6SS) is a membrane-attached contractile phage tail that is physically and Mechanistically similar to a membrane-linked intracellular contractile phage tail. T6SS spike and tube elements, as well as anti-bacterial and anti-eukaryotic effectors, are propelled out of predatory T6SS positive cells and into target cells by a fast conformational shift in the structural framework of a sheath protein complex, according to recent research (Kudryashev et al., 2015).

However, the limited studies and lack of information on the T6SS in K. pneumoniae necessitate further exploration to clarify the physiological metabolism and pathogenic information of this clinically important bacterial species.

Eligibility Criteria:
Inclusion Criteria:

* All patients suffering from infections that can be caused by Klebsiella Pneumoniae.

Exclusion Criteria:

* Samples diagnosed to have organisms other than Klebsiella Pneumoniae
Dermacyd PH_DETINLYN (Lactic Acid) Sweet Flower - Compatibility

To demonstrate the absence of irritation potential (primary dermical irritability and cumulated dermical irritability) and allergy (sensibilization) of the product Dermacyd PHDETINLYN Sweet Flower.


Eligibility Criteria:
Inclusion criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region;
* Willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion;

Exclusion criteria:

* Lactation or gestation
* Use of Antiinflammatory and/or immunossupression drugs
* Personnel history of atopy

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

* History of sensitivity or irritation for topic products;
* Active cutaneous disease;
* Use of new drugs or cosmetics during the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Edtech-HPV: A Community Approach Using Education and Technology to Increase HPV Vaccination

This study is a two-arm randomized controlled trial, implemented to assess the effectiveness of a community-based educational program with and without a text messaging reminder system, in increasing the rate of HPV vaccination completion among children of Mexican Americans.

The investigator's have extended the duration that participants are followed in assessing their child's uptake of the HPV vaccine to coincide with the COVID-19 related clinic closures and/or allow flexibility for participants who decide to delay their child's vaccination for fear of exposure to the COVID-19 infection.

A survey will also assess the participants concerns regarding the impact COVID-19 has had in their daily life, such as financial insecurity, food access, housing insecurity and among other most common concerns during this unprecedented time. Additional navigation, referrals and interviewer notes will also be captured. Participants may be called by site or MSK staff to complete study surveys and will be informed verbally or by a mailed letter.


Eligibility Criteria:
Inclusion Criteria:

* Born in Mexico or born in U.S. but self-describes as Mexican-American
* Spanish is his or her primary language
* Has a minimum of one child between the ages of 11 and 17 who has not initiated or completed the HPV vaccine seriest (as per the age-recommended timeframe)
* Self-identifies as the child's main caregiver
* Currently owns a cell phone and uses text messaging services and is willing to accept text messages for this study
* 21 to 84 years old

Exclusion Criteria:

* Presence of a serious psychiatric or cognitive impairment likely to preclude meaningful informed consent and adherence to the protocol per the consenting professional's judgment.
Treatment of Adult ADHD With Atomoxetine or Atomoxetine and Buspar

Determine if there is a difference in treatment response for adults with ADHD who are treated with Strattera versus those treated with a combination of Strattera and buspirone


Eligibility Criteria:
Inclusion Criteria:

* Adults with ADHD

Exclusion Criteria:

* Other Axis I Psychiatric Disorders
Incidence and Contributing Anthropometric Factors of Difficult Airway in Pediatric Surgical Patients

The goal of this prospective, observational study is to identify predictors of difficult mask ventilation, direct laryngoscopy and intubation in pediatric patients scheduled for elective surgery and to determine their incidence. As a final goal, the investigators will try to define new scoring system for difficult airway prediction. Participants will be pediatric patients age infant till school age. Participants will have their airway assessed one day before surgery by taking anthropometric measurements of face and neck. After iv anesthesia induction and application of muscle relaxant, the investigators will assess difficulty of face mask ventilation by using grading from 0-4. Direct laryngoscopy will be performed with Macintosh blade and experienced anesthesiologist will determine Cormack - Lehane score as well as intubation difficulty score (IDS).

Participants will be divided into groups: up to 1 yrs of age, 1-2.9 yrs, 3-4.9, 5-6.9, and 7 yrs and older.

The investigators will test predictive value, sensitivity and specificity of anthropometric parameters used for airway assessment in pediatric patients, as well as gender, age, BMI, ASA score.

Anatomical parameters that will be measured the day before surgery: chin, inter - incisor gap, hyomental distance (HMD), hyoid - thyroid distance (HT), neck circumference, neck length, neck extension, lower lip to chin distance (LCD), tragus to chin distance (TMA), thyromental distance (TMD), sternomental distance (SMD).

Mallampati test will be performed in children older than 5 years and best oropharyngeal view (BOV) will be determined for younger children. Colorado Pediatric Airway Score (COPUR) will be calculated.

All patients will be premedicated with midazolam 0.5 mg/kg orally, 30 minutes before intervention or 0.1 mg/kg iv. Anesthesia induction will be intravenous: thiopentone 5 mg/kg or propofol 2.5 mg/kg, fentanyl 3 mcg/kg and non depolarizing muscle relaxant rocuronium 1 mg/kg or cis-atracurium 0.15 mg/kg. Face mask ventilation will be quantified as grade 0-4. Anesthesia maintenance will be intravenous or inhalatory depending on anesthesiologists decision. Patients will be intubated with Macintosh blade in the supine position, without additional elevation of occipital part of the head. Difficult laryngoscopy is defined as CL grade III and IV and they predict difficult endotracheal intubation. Intubation difficulty score will be used to asses intubation. Intubation difficulty will be defined by IDS - intubation difficulty score \> 5.

Standard procedures will be performed in case of difficult mask ventilation and intubation.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients from one month to 14 years old scheduled for elective surgery in general endotracheal anesthesia.

Exclusion Criteria:

* Congenital syndromes which include difficult airway (Pierre Robin, Goldenhar syndrome, Treacher Collins syn, Down syn, Edwards, Arthrogryposis, Apart syn etc.), craniofacial dysmorphia, ENT, maxillofacial and cardiac surgery patients, patients with resent respiratory infections
MRI of the Chest Under High Frequency Ventilation

The purpose of the study is to evaluate the benefit on image quality of MRI of the chest performed under high frequency non-invasive ventilation. This technique indeed allows to generate an apnea duration of several minutes with acquisitions performed at full inspiration. This study will be applied on healthy subjects.

High frequency ventilation (HF-V) has been applied by using a non-invasive interface allowing to obtain a prolonged apnea in awaken subjects. Such an application should be of interest for MRI taking into account its susceptibility to motion of the chest and the imperfect techniques of respiratory gating that are usually performed at end expiration. The purpose of this study is to assess the benefit on image quality of different sequences performed with and without the device in healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjets : normal respiratory function and no known lung disease
* Age \>=18y

Exclusion Criteria:

• Pregnancy
Effects of L-Carnitine on Gastric Emptying in Children With Drug Resistant Epilepsy on Ketogenic Diet

This study was conducted on thirty children aged from12 months to 18 years newly diagnosed with drug resistant epilepsy and following up at Pediatric Nutrition and Neurology Outpatient Clinics assigned randomly into 2 groups, group1: patients who started ketogenic diet with L-carnitine and group2: patients who started ketogenic diet only.


Eligibility Criteria:
Inclusion Criteria:

* All infants and children aged from 12 months to 18 years old newly diagnosed with drug resistant epilepsy and were assigned to start KD.

Exclusion Criteria:

* Patients with intolerance or non-compliance to ketogenic diet therapy.
* Patients for epilepsy surgery or vagal nerve stimulation.
* Children with history of previous abdominal operations.
* Children with history of GI diseases affecting GI motility before starting KD.
* Children with tube feeding or feeding gastrostomy or jejunostomy.
Evaluating System Change to Advance Learning and Take Evidence to Scale (ESCALATES)

The purpose of this study is to evaluate approximately eight grants that will test interventions to improve cardiovascular disease prevention. The investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies. The investigators will observe grantees and selected practices to understand why and how those combinations are effective. The investigators will also gather data from the grantees to assess how effective the interventions are.

The purpose of this study is to evaluate approximately eight different R18 grants that will test practice change interventions to improve cardiovascular disease (CVD) prevention screening. The investigators will collect and analyze quantitative data (context, process, and outcomes) to identify the most effective combinations of intervention strategies for various practice types in relation to practice structure, context, and organizational characteristics associated with change in outcomes. The investigators will collect qualitative data (observation, interviews, online diaries) from grantees and selected practices to understand why and how those combinations are effective. The investigators will also gather documents and de-identified quantitative data from grantees.

Evidence clearly shows that many people do not receive guideline-concordant health care; this is true even for low cost treatments such as Aspirin prescribing, Blood pressure and Cholesterol control and Smoking cessation (the ABCS) known to prevent cardiovascular disease (CVD). In hospitals and integrated care systems with substantial resources, large quality improvement campaigns have been shown to increase adherence to guidelines by creating communities of learning that change behavior on a large scale. Agency for Healthcare Research and Quality (AHRQ) and the Patient Centered Outcomes Research Institute (PCORI) are partnering to launch a campaign to promote the improvement of guideline-based CVD preventive care in small primary care practices with limited resources and experience with quality improvement ("Implementation" RFA-HS-14-008). The practices for each of these R18 grants will be in a contiguous geographic region. This study will evaluate each of these R18 implementation grants.

The investigators' strategy is to conduct a prospective observational analysis to evaluate the effectiveness of the R18s ABCS quality improvement initiatives. To do this, the investigators will collect and analyze qualitative data to identify the most effective combinations of intervention strategies for various practice types, contexts, and organizational characteristics, and to understand why and how those combinations are effective. The investigators will also gather de-identified quantitative data that the R18s collected.

Eligibility Criteria:
Inclusion Criteria:

* All R18 grant awardees are included in the study.

Exclusion Criteria:

* N/A