cyrilzakka/clinical-trials huggingface dataset:
A Pilot Study of Metabolic Effects of Omentectomy

PROTOCOL SUMMARY

Type of Study: Pilot, randomized and single center trial Test Procedure: Omentectomy Aim 1. Determine the effect of omentectomy on 1) insulin sensitivity, 2) beta cell function and 3) plasma markers of inflammation We hypothesize that removal of omental fat increases insulin sensitivity and pancreatic sensitivity to glucose, and decreases systemic inflammation.

Aim 2. Identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity for future study.

We hypothesize that the genetic samples will help us to identify genes and proteins in adipocytes from obese patients that affect clinical presentation versus those that are affected by obesity and help us to design future obesity genetic studies.

Total Enrollment Number: 30 patients who are scheduled to undergo bariatric surgery for weight loss at New York University Medical Center will be invited to participate in this study. Subjects will be randomly assigned, by using a computer-generated randomization scheme, in a single-blind fashion to either the omentectomy (n=15) or control group (n=15).

Inclusion Criteria:

* Patients who consented to undergo LAGB for weight loss and consent to participate in this study
* BMI ≥35 kg/m2
* Confirmed T2DM treated with oral agents and/or only diet therapy
* Age 18-64 years

Exclusion Criteria:

* Insulin therapy
* Weight change (\>2% body weight) within 4 weeks before surgery
* Patients with T2DM for more than 10 years

Research Design- Pilot Study Event Week (approximate) Medical Screening (in conjunction with routine pre-op visit) -4 OGTT \& randomization -2 Preliminary genetic testing for the future study (blood sample) -2 Surgery with or without omentectomy 0 Preliminary genetic testing for the future study (fat sample) 0 Weight stabilization visit (in conjunction with routine post-op visit) 2 Weight stabilization visit (in conjunction with routine post-op visit) 4 OGTT 6

STUDY PLAN

Study has approved by IRB, NYU School of Medicine Committee, GCRC, and Bellevue Hospital.

Study initiation date: November 01, 2007

Enrollment period: Nov. 2007 to Nov. 2008

Study period: Nov. 2007 to Jan 2008

Eligibility Criteria:
Inclusion Criteria:

* Patients who consented to undergo LAGB for weight loss and consent to participate in this study
* BMI ≥35 kg/m2
* Confirmed T2DM treated with oral agents and/or only diet therapy
* Age 18-64 years

Exclusion Criteria:

* Insulin therapy
* Weight change (\>2% body weight) within 4 weeks before surgery
* Patients with T2DM for more than 10 years
Imaging of Brain Amyloid Plaques in the Aging Population

This is a prospective, open label, non-therapeutic, diagnostic imaging study. The purpose of this study is to utilize Pittsburgh Compound B positron emission imaging (PiB PET) to ascertain the relationship between change in amyloid burden over time, and concurrent change in clinical status.

Identification of risk factors and biomarkers of neurodegenerative disease is essential in caring for the growing numbers of elderly. Imaging biomarkers provide non-invasive ways to look at brain function. A new PET imaging agent, Pittsburgh Compound B (PiB), that identifies brain amyloid is an exciting development in brain imaging that needs to be studied. We plan to study this imaging technique in normal volunteers and patients with a variety of neurodegenerative diseases to determine its utility. Long term followup of these subjects will allow us to understand the predictive ability of this new test.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-100
* Subjects who have completed or are scheduled to undergo the neurological evaluation procedures in the Mayo Clinic Study of Aging, Mayo ADRC, or Mayo neurodegenerative disease clinics.

Exclusion Criteria:

* Subjects unable to lie down without moving for 10 minutes
* Women who are pregnant or cannot stop breast feeding for 24 hours
* Claustrophobic patients unable to tolerate the scans
* Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc.
The Correlation and Intervention of Intestinal Flora and Frailty in the Elderly

The study aim to evaluate the improvement and correlation of soluble dietary fiber (prebiotics) in the frailty of elderly people by a randomized, double-blind, placebo-controlled clinical trial.

100 healthy controls, 100 pre-frailty and 100 frailty elderly will be included. the healthy controls will be received no intervention. The pre-frailty will be randomized at a 1：1 ratio to receive prebiotics (inulin) or placebo (maltodextrin) . The degree of improvements and correlation in frailty will be evaluated three months later.Similarly,the frailty also will be randomized at a 1：1 ratio to receive prebiotics (inulin) or placebo (maltodextrin). The degree of improvements and correlation in frailty will be evaluated three months later.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years;
* Can get up from a chair and walk 6 meters
* Clearly consciousness, able to read or use words to express and communicate without difficulty
* Agree and accept the study plan

Exclusion Criteria:

* Acute and chronic inflammatory disease of the intestine within 3 months
* Use of antibiotics, probiotics, prebiotics or synthetics, laxatives or diarrhea medications, proton pump inhibitors or gastric motility drugs within 1 month
* Dementia
* mental illness or blindness
* acute infection
* cancer
Contextualizing & Responding to HIV Risk Behaviors

The purpose of this study was to pilot test the potential for improvement in antiretroviral medication adherence of a an adapted group-based, multi-session, community-based Antiretroviral Therapy (ART) adherence and risk reduction intervention, Project ADHerence Education and Risk Evaluation (ADHERE). Project ADHERE was compared to a single-session group-based medication adherence intervention, Medication Adherence and Care Engagement (MACE).

A secondary aim was to examine the impact of Project ADHERE on HIV risk behaviors (i.e., illicit drug use and unprotected sexual behavior).

This study was designed to inform, design, and pilot test the two antiretroviral medication adherence interventions for HIV-infected formerly incarcerated individuals.

Formerly incarcerated Black drug offenders are at an elevated risk for HIV infection. Despite substantial research expressing the need for HIV prevention services for ex-offenders postrelease, this population has limited access to quality programming and services related to HIV risk reduction. This K01 application seeks to inform and adapt an HIV risk reduction intervention to address the needs of formerly incarcerated Black drug offenders who are being released from prisons in the New York City metropolitan area.The study will utilize qualitative and quantitative methods to inform and adapt an HIV prevention intervention for this study population.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years of age
2. HIV seropositive with "detectable" viral load (VL)(defined as \>50 copies/mL)
3. history of drug use (used illicit drugs within the past year)
4. experienced incarceration in prison or jail within the past five years

Exclusion Criteria:

1. living in a healthcare or assisted living facility
2. experienced incarceration longer than five years ago
Effects of Inhaled Corticosteroids in Chronic Obstructive Pulmonary Disease (COPD)

Human and animal studies have shown that inhaled corticosteroids (ICS) decrease airway blood flow . This effect is immediate (within 30 minutes), transient (lasting 90 minutes), and in animal studies independent of gene expression. In COPD patients, decrease in bronchial blood flow may also decrease mucosal edema, airway resistance and improve small airway function. If such an effect exists, then we should be able to measure improvements in airway conductance and reduce lung hyperinflation, which would have salutary effects on dyspnea and exercise endurance.

To our knowledge, no study has examined the immediate effect of ICS on small airway function in COPD. The purpose of this study is to examine the effects of nebulized Pulmicort on small airway function (spirometry, plethysmographic lung volumes, airways resistance, closing volume, partial flow-volume loop analysis) and exercise endurance in patients with moderate to severe COPD.

HYPOTHESIS

1. Nebulized ICS will immediately improve airway function compared with placebo (nebulized saline).
2. Enhanced lung emptying and reduced operating lung volumes during rest and exercise following ICS therapy will translate acutely into clinically important reductions in exertional dyspnea and improvements in exercise endurance.

This will be a single site, pilot, randomized, double-blinded, placebo-controlled, cross-over study that will be conducted at this centre. Subjects will be required to complete four (4) visits to the laboratory over a one-month period.

At Visit 1, subjects who meet all study inclusion and exclusion criteria, will have a full set of pulmonary function tests (PFT) done and complete a symptom-limited incremental cycle exercise test. At Visit 2, subjects will have a partial set of pulmonary function tests (PFT) done and complete a symptom-limited constant load cycle exercise test. On the third and fourth visit subjects will be randomized to treatment with either nebulized saline or nebulized Pulmicort® in a double blinded, cross-over design, subsequent to which they will have their PFT's and symptom limited constant load exercise testing done.

Eligibility Criteria:
Inclusion Criteria:

* FEV1 less than/equal to 70 % predicted, FEV1/FVC ratio less than/equal to 70%, and FRC greater than/equal to 120 % predicted
* Moderate to severe chronic activity-related dyspnea (modified Baseline Dyspnea Index focal score less than/equal to 6)
* Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding four weeks
* Males or females greater than 40 years of age;
* A cigarette smoking history of at least 20 pack-years
* Able to perform all study procedures and sign informed consent

Exclusion Criteria:

* History of asthma, atopy or nasal polyps
* Recent history of cardiovascular disease (\< 1 year) or other significant disease that could contribute to dyspnea or exercise limitation
* Oxygen saturation less than 80% during exercise on room air
Study of Treatment of Thoracic Aortic Aneurysms and Dilatation in Combination With Tricuspid and Bicuspid Aortic Valves.

Clarification of indications for surgical correction in patients with borderline expansion of the ascending aorta

Expanding indications for surgical treatment of patients with borderline values of the ascending aorta

Eligibility Criteria:
Inclusion Criteria:

1. Extension of the ascending aorta less than 55 mm
2. Tricuspid Aortic Valves.
3. Extension of the ascending aorta more than 45 mm

Exclusion Criteria:

1. Age less 45 years
2. Age more 75 years
3. Multiple organ failure
4. oncological disease
A Finding Balance Writing Intervention for Older Bereaved Caregivers

The overall purpose of this study is to develop and pilot-test a theory-based psychosocial supportive "finding balance" intervention for older, bereaved spousal caregivers of a palliative cancer patient.

Research devoted to determining the efficacy of bereavement interventions remains a top priority. The development of theory-based, acceptable and feasible psychosocial interventions would begin to address the needs of family caregivers. A prominent theory of coping with bereavement, Stroebe and Schut's Dual Process Model, describes oscillation between loss-oriented and restoration-oriented coping; having a balance between these processes predicted more positive outcomes for older bereaved spouses. Similarly, the process of "finding balance" emerged as a first step in the search for new hope in the PI's grounded theory research with older bereaved family caregivers. They described the importance and difficulty of "finding balance" as they recovered from caregiving and struggled to find a new meaning and purpose for their lives after the loss of a spouse to cancer. An intervention focused on "finding balance" provides an innovative and promising approach to guiding the development of a theory-based psychosocial intervention for family caregivers who become bereaved. In clinical work a highly focused writing intervention has shown important benefits (personal communication, Dr. Robert Neimeyer, March 4, 2009). A validated tool to measure the effectiveness of an intervention to find balance does not exist, however valid existing measures of hope, grief, and an inventory of balance based on the Dual Process Model will be used as proxies. Therefore, the overall purpose of this study is to develop and pilot-test a theory-based psychosocial supportive "finding balance" intervention for older, bereaved spousal caregivers of a palliative cancer patient.

Eligibility Criteria:
Inclusion Criteria:

* women and men, ages 60 and over, who previously resided with and provided care for a spouse with terminal cancer who died within the last year, English speaking, and freely consenting to be involved in the study.

Exclusion Criteria:

* will be those cognitively impaired, non-autonomous, or not able to give a free and informed consent, as determined by the registered nurse research assistant on initial contact.
PROMOTE Study: Prediction of Response Of HorMOnal Treatment in Advanced and Recurrent Endometrial Cancer

The PROMOTE study aims at optimising use of hormonal therapy in advanced stage and recurrent endometrial cancer analysing tumor tissue taken before start of hormonal therapy

There is limited consensus about the position of hormonal treatment in advanced and metastatic endometrial carcinoma (EC). This is due to lack of good quality data on patient selection, and predictive biomarkers. Consequently, consideration of hormonal therapy is subjected to personal experience of the treating physician, rather than on refined clinical and up-to-date molecular criteria. Hormonal therapy has limited side-effects, and is better tolerated than systematic chemotherapy. Since EC patients are often elderly women with comorbidities, more effective and less aggressive treatment options are needed, underlining the urgency of an explorative study on this topic.

Endometrial cancer is the most common malignancy of the female genital tract in developed countries, with increasing incidence due to obesity and increased life expectancy. Most patients are diagnosed at an early stage, and have a favourable prognosis with surgery alone. Yet, 20% of the patients present with advanced or metastatic EC and have a poor outcome even with systemic treatment. Response rate of chemotherapy in advanced or metastatic EC is 30-60%, dependent of previous chemotherapy, with a progression free survival (PFS) of 3-14 months and 40% treatment related morbidity. In comparison, response to hormonal therapy is 20%-40%, with side effects in less than 5%. The overall PFS is 3 months, yet for those who respond the PFS can be up to several years.

To improve selective use of hormonal therapy in EC by evaluating applied hormonal therapy in advanced and metastatic EC and correlate response to molecular tumour analysis and translate this knowledge after validation into clinical practice

Eligibility Criteria:
Inclusion Criteria:

* Advanced stage (FIGO stage III and IV) and recurrent endometrial cancer
* All histologic types of endometrial carcinoma
* Planned treatment with any type of hormonal therapy
* Biopsy taken within 120 days prior to start of hormonal therapy with no intercurrent therapy between biopsy and start of hormonal therapy.

Exclusion Criteria:

* Adjuvant hormonal therapy started following complete resection of endometrial carcinoma
* Synchronous use of hormonal therapy for other indications
* Endometrial sarcoma or endometrial stroma cell sarcoma
Lipografting Versus Steroid Injections for Treatment of Carpal Tunnel Syndrome

This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. The investigators hypothesize the fat transfer would prevent scar formation and aid in nerve excursion along the canal (while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration) better than the standard of care treatment.

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy affecting up to 13% of Americans; CTS is caused by compression of the median nerve in the carpal tunnel leading to nerve ischemia and symptoms of numbness, pain, and tingling. Treatment options depend on the severity of symptoms and range from noninvasive options (most commonly, steroid injections) to definitive surgical release of the compressed median nerve. Both non-invasive techniques and surgical intervention have their shortcomings; thus a novel approach for CTS treatment may be indicated.

Lipografting is an established, validated, and widely used technique of plastic surgeons that injects autologous fat to correct contour deformities. From observing these reconstructions, plastic surgeons have witnessed the regenerative properties of fat transfer, specifically delaying the affects of chronic radio-dermatitis. These clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. Ideally, the fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors could stimulate nerve regeneration.

Eligibility Criteria:
Inclusion Criteria:

* primary mild to moderate carpal tunnel syndrome (CTS)
* report symptoms longer than 6 months
* night pain
* weakness
* sensory deficits
* fluent English-speaking adult (\>18)

Exclusion Criteria:

* \<18 years old
* Non-english speaking
* injection in past 6 months
* previous hand surgery
* previous hand trauma (fracture or dislocation)
Art Therapy in Acute Schizophrenia

Randomised, controlled, single-blinded pilot study to assess the efficacy of psychodynamic art therapy in a sample of hospitalized, (sub)acutely psychotic patients with a diagnosis of schizophrenia compared to a group of patients receiving treatment as usual.

\*Main hypothesis: Art therapy has no impact on clinical symptoms and the course of remission compared to TAU.

\*Exploratory hypotheses: Art therapy has no influence on quality of life, mentalizing function, self-efficacy and neuroleptic dosage compared to TAU.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of schizophrenia according to DSM-IV-TR
* age 18-64 yrs
* sufficient German language competency
* written informed consent

Exclusion Criteria:

* axis-I mental disorders other than schizophrenia
* comorbid antisocial personality disorder, relevant substance abuse,
* relevant severe somatic disease
* acute suicidal tendencies or aggression
* incapability to tolerate group settings
Study Investigating OCT, Multifocal ERG, and Microperimetry in Monthly Versus PRN Ranibizumab in Neovascular Age-Related Macular Degeneration

Visual outcomes using monthly ranibizumab therapy are well established in clinical trials, but the best way to assess when and how to treat patients with PRN therapy has not been proven. Information is lacking on Multi-focal ERG and microperimetry outcomes with ranibizumab therapy. Additionally, VA and OCT outcomes don't always correlate and other assessments such as the Multi-focal ERG and microperimetry may be useful as early predictors of when patients should be retreated. This study will assess 2 groups (monthly and PRN therapy) and assess high resolution OCT, microperimetry, and Multi-focal ERG outcomes. For the PRN group retreatment will be based on OCT criteria. We will investigate if microperimetry or multifocal ERG would have been an early predictor of fluid recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
* Age greater or equal to 50 years old.
* Patients with active neovascular AMD

Exclusion Criteria:

* Pregnancy (Positive pregnancy test) or lactation.
* Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
* Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
* Participation in another simultaneous medical investigation or trial
* Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma)
* Previous PDT therapy
* Previous intravitreal steroid therapy within last 3 months
* Previous anti-VEGF therapy in the past month
Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection

The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic hepatitis C genotype 1 infection
* BMI 18 and 38 kg/m2
* Null responder to pegylated interferon alpha and ribavirin

Exclusion Criteria:

* Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Significant liver disease in addition to hepatitis C
* Decompensated liver disease medical history or current clinical features
* Histologic evidence of hepatic cirrhosis
* Concurrent clinically significant medical diagnosis (other than CHC)
* Concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation)
* Clinically significant illness within 30 days preceding entry into the study
* Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication
* History of clinically significant allergic drug reactions