cyrilzakka/clinical-trials huggingface dataset:
Community to Clinic Linkage Program at SFGH

It is increasingly clear that the environment in which a child lives, plays, and goes to school has a significant impact on their health. With the implementation of a Community to Clinic Linkage Program (CCLiP) in the SFGH Pediatrics Clinics, we will routinely address Social Determinants of Health when families present. We will randomize patients to receive either the CCLiP intervention or standard of care. We will evaluate programmatic outcome, health care utilization data and return on investment data. We hypothesize that by addressing the environmental and social factors that contribute to health within the setting of the medical home, we will be able to better connect families to community resources, enable more appropriate use of healthcare resources, improve health status, and enhance patient satisfaction.

We are proposing a 4-arm, 18 month randomized control clinical trial to address social determinants of health, improve health status and health care satisfaction, and change health care utilization patterns in the Pediatric Urgent Care and Primary Care Clinics at San Francisco General Hospital. We will compare our CCLiP protocol to standard of care in both the Pediatric Primary Care Clinic \& Urgent Care. All arms (intervention and control) include a baseline survey including social needs assessment, health care status, health care satisfaction and health care utilization assessment; and two telephone-based follow up surveys at 3 and 6 months. Patients in the intervention arms (whether in urgent care or primary care) will receive a maximum of 3 months of intervention protocol which includes a 30 minute on-site intervention at time of enrollment in addition to twice monthly follow-up phone calls for up to 3 months to help address social needs. Patients in all arms will receive 3 and 6-month follow up surveys.

Eligibility Criteria:
Inclusion Criteria:

* English or Spanish Speaking
* Parent/caregiver accompanying an SFGH Primary Care or Urgent Care Clinic patient 0-17 years old
* Consenting adult over or equal to 18 years old

Exclusion Criteria:

* Non-English or non-Spanish speaking caregiver
* Caregiver under age 18
* Caregiver accompanying patient is not familiar with the child's living situation
* Family participated in study previously
* Non-San Francisco resident
* Foster child or child in clinic for a child protective clearance exam
RECOVER I Impella RECOVER LP/LD 5.0 Support System Safety and Feasibility Study

To demonstrate that that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass.

To demonstrate that the device is safe and potentially efficacious for use as a left ventricular cardiac assist device for postcardiotomy patients who require hemodynamic support post weaning from cardiopulmonary bypass. Postcardiotomy patients, weaned from a cardiopulmonary bypass system (CPB) in need for hemodynamic support due to ineffective standard medical therapy will be considered for enrollment. An attempt shall be made to reverse the hemodynamic situation with medications (e.g. inotropes, vasopressors). The IMPELLA RECOVER LP/LD 5.0 will be implanted by the surgeon when no improvement in hemodynamics is observed.

Eligibility Criteria:
Inclusion Criteria:

* BSA
* Receiving stable infusion of one high dose inotrope or two medium dose inotropes for a respective minimum time indicated.
* C.I.
* Elevated Filling Pressures, PCWP or PA
* Time to enrollment within 48 hours from weaning

Exclusion Criteria:

* Renal dysfunction
* Hepatic dysfunction
* Right Ventricular failure defined.
* LV or RV Thrombus
* Other exclusions per protocol
Paravertebral Catheter for Lung Transplant

This is a prospective observational trial of patient undergoing lung transplantation who have a thoracic paravertebral catheter(s) placed for postoperative pain control. Patients pain scores and opioid use were evaluated for 7 days after placement as well as any complications, opioid adverse events, and length of stay.

Following approval of the University of Minnesota Institutional Review Board, 33 consecutive adult patients (≥ 18 years of age) were observed from October 2013 to December 2014 who underwent either single or bilateral lung transplantation and received a continuous paravertebral block. The paravertebral catheters were placed within 1-2 day postoperatively in the intensive care unit. If the patient was too hemodynamically unstable or too critically ill to be placed in lateral decubitus position, the placement of the catheter was delayed or in some cases not performed (these patients were not included in study) They were placed via an in plane transverse technique. The ultrasound was placed on the patient's back at the T8-9 level with probe in transverse orientation. Then a 17-gauge tuohy needle was advanced lateral to medial in plane until beneath the transverse process upon which a test dose of 3-5 mL of 1.5% lidocaine with 1:200,000 epinephrine was injected to see adequate spread. The catheter was then fed 1 centimeter past the tip of the tuohy needle and needle was withdrawn. All catheters were confirmed to be in correct position with real time local anesthetic injection and secured with skin glue and occlusive dressing. Each was performed with the patient in the left lateral decubitus position for the right catheter and right lateral decubitus position for the left catheter. The paravertebral catheters remained in place for up to seven days postoperatively in unilateral lung transplants and up to ten days postoperatively in bilateral lung transplants. During that time an infusion of 0.2% ropivacaine was infused at a rate of 0.2-0.25 ml/kg/hour through an elastomeric pump (ON Q Halyard Health).

The outcome measured were minimal and maximum pain scores from the first 7 days post paravertebral catheter placement (rated on an 11-point numeric rating scale; 0=no pain, 10=worst pain imaginable). The acute pain Nurse Practitioners, bedside nurses, or acute pain anesthesiology residents collected the pain scores. Additional outcomes of interest included postsurgical opioid use through postsurgical day 7, and length of hospital stay. Patients were asked daily if they experienced nausea/vomiting, however, Nursing notes and physician progress notes were also evaluated if patients experienced any adverse events or nausea and vomiting. Demographics such as age and weight were recorded in addition to length of surgery and time spent in the hospital before discharge.

Eligibility Criteria:
Inclusion Criteria:

* lung transplant
* clamshell incision
* received paravertebral catheter within 2 days of surgery

Exclusion Criteria:

* non english speaking
* remained intubated for greater than 3 days postoperatively
* midline incision
* allergy to local anesthetics
Study on MAFLD-related Cirrhosis Prevention and Treatment Strategies

To establish a prospective, multicenter, biopsie-confirmed clinical cohort of MAFLD-related cirrhosis (F3-F4) in China, and analyze the clinical, histopathological features and natural outcomes of MAFLD-associated liver fibrosis/cirrhosis in China. And than to conducted a real-world study of different strategies of Chinese characteristics for the prevention and treatment of MAFLD-related cirrhosis to evaluate the efficacy and safety of the strategies.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years old, gender and ethnicity are not limited;
2. Meet the diagnostic criteria for MAFLD;
3. F0-F4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks;
4. Be willing to sign informed consent.

Exclusion Criteria:

1. Cirrhosis due to any chronic liver disease other than MAFLD (including but not limited to alcohol or drug abuse, medications, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency);
2. Any clinical evidence or history of peritonitis, varicose bleeding, or spontaneous encephalopathy;
3. According to the investigators' assessment, a history of heavy drinking for more than 3 months continuously within the previous year was selected. (Note: Heavy drinking was defined as more than 20 g per day on average for female subjects and more than 30 g per day for male subjects).
4. Use of NAFLD-related medication history (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, larger than hormone replacement doses of estrogen, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks within the year prior to screening.
Asthma in the Elderly: The Role of Exhaled Nitric Oxide Measurements

This study will investigate the importance of exhaled nitric oxide measurements in subjects with asthma age 65 and older. This group of patients has been ignored in most previous asthma studies.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with asthma over the age of 65 followed in our practice, non-smokers and able to give informed consent to participate in the study

Exclusion Criteria:

* Smokers, subjects of diminished mental capacity
A Study Comparing Daily Treatment With Valaciclovir To Placebo For Suppression Of Herpes Simplex Virus HSV-2 Genital Herpes In Newly Diagnosed Patients. VALTREX® Tablet is a Trademark of the GlaxoSmithKline Group of Companies.

Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advantages to using suppressive vs. episodic treatment, which include increased intervals between the pain and discomfort of genital herpes recurrences. Therefore, this study will collect safety and efficacy data on suppressive therapy with valaciclovir in subjects newly diagnosed with HSV-2 genital herpes.


Eligibility Criteria:
Inclusion criteria:

* In overall general good health.
* Females can enter and participate in this study if they are of non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or if of childbearing potential, has a negative pregnancy test (urine) at screening and agrees to use GSK stipulated contraceptive methods.
* Must be newly diagnosed with a first recognized episode of GH at the time of the Screening Visit or within 3 months prior to the Screening Visit.

Exclusion criteria:

* Known or suspected to be immunocompromised (e.g., subjects receiving immunosuppressive therapy or chemotherapy for malignancy, or are seropositive for HIV).
* Received an investigational drug in the 30 days prior to the study.
* Receiving systemic antiviral or immunomodulatory treatments.
* Must not have received systemic antiviral treatments (e.g., valaciclovir, Famvir (famciclovir), acyclovir, lysine) within 3 days of starting study drug or immunomodulatory treatments in the 30 days before starting study drug.
* Clinically significant impaired renal function as defined by a creatinine clearance \<30 ml/min, calculated using the Cockcroft-Gault formula.
* Clinically significant impaired hepatic function defined as an ALT (alanine transaminase) level \> 5 times the normal upper limit.
* Subjects with active liver disease.
* Known to be hypersensitive to acyclovir, famciclovir, ganciclovir or any component of valaciclovir formulations.
* Known resistance to acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir or valganciclovir.
* Subjects with malabsorption or vomiting syndrome or other gastrointestinal dysfunction that might impair drug pharmacokinetics.
* Women contemplating pregnancy within the duration of the study drug dosing period.
* Women who are pregnant and/or nursing mothers
* Current history of alcohol or drug abuse.
* Received suppressive (daily) therapy for genital herpes prior to enrollment.
Comparison of Different Amputation Levels

Lower limb amputation is a factor that changes the individual's weight transfer, gait pattern, and trunk balance. This change plantar pressure distribution of both side and cause a series of problems to be exposed over time according to level of amputation. The aim of this study is to reveal the relationship between amputation level-postural balance and amputation level-plantar pressure distribution.


Eligibility Criteria:
Inclusion Criteria:

* Being unilateral transfemoral or transtibial amputee
* Have the level of perception to understand and apply the commands given
* Having sedantary life styles

Exclusion Criteria:

* Having a neurological or orthopedic disorder that may affect standing posture and balance
* The presence of pain that can affect standing posture and balance
* Visual impairment that impairs the gait pattern and balance
Safety Study of Intracerebral Topotecan for Recurrent Brain Tumors

This study will evaluate the safety and efficacy of a chemotherapeutic drug (topotecan) as it is given directly into brain tumors by a delivery technique called convection-enhanced delivery. This drug has been used for different types of cancer, but in this study it will be given by an experimental delivery technique designed to maximize the amount of drug delivered to the brain tumor and minimize the side effects in other parts of the body.

This study will also evaluate advanced magnetic resonance (MR) imaging techniques.

The study will assess quality of life parameters throughout the follow-up period.

Clinical efficacy with chemotherapy has been discouraging for malignant brain tumors, mostly because of side effects and delivery limitations. Because they are locally invasive and rarely metastasize, malignant gliomas have features that make them uniquely amenable to new strategies of regional drug delivery. Intracerebral clysis (convection-enhanced delivery) is a novel drug delivery strategy that uses a microinfusion pump to establish a pressure gradient in the brain via implanted catheters. The pressure gradient produces convective forces that distribute a therapeutic agent throughout the tumor and surrounding brain tissue.

Non-invasive magnetic resonance imaging (MRI) methods of monitoring drug distribution and treatment response have been developed to maximize the clinical applications and minimize complications associated with treatment risks.

Study participants will be taken to the operating room to have 2 catheters surgically placed into their tumor and surrounding tumor bed. These catheters will then be connected to small infusion pumps which will slowly infuse topotecan continuously over 4-5 days. Patients will have daily MRI scans while in the hospital. Upon completion of the experimental treatment, patients will be discharged and will be followed up in the outpatient clinic.

Eligibility Criteria:
Inclusion Criteria:

* Single primary malignant brain tumor
* Previous treatment with external beam radiation
* Tumor is stereotactically accessible
* Karnofsky Performance Score of at least 60

Exclusion Criteria:

* Diffuse subependymal or Cerebrospinal fluid (CSF) disease
* Tumor involves brainstem, cerebellum or both hemispheres
* Active infection
* Systemic disease associated with unacceptable anesthetic/operative risk
* Previous treatment with topotecan
* Unable to receive MRI scans
Effect of Panitumumab on the Pharmacokinetics of Irinotecan

The primary objective of this study is to determine if panitumumab affects the pharmacokinetic (PK) profile of irinotecan.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed unresectable metastatic colorectal cancer (mCRC) which has progressed on at least one prior 5-fluorouracil (5FU)-containing chemotherapy regimen
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy of ≥ 3 months as documented by the investigator
* Baseline actual body weight ≤ 160 kg
* Competent to comprehend, sign, and date a written Institutional Review Board (IRB) approved informed consent form before any study-specific procedures are performed

Exclusion Criteria:

* Treatment with radiotherapy ≤ 14 days before enrollment. Patients must have recovered from all radiotherapy-related toxicities
* Known presence of central nervous systems (CNS) metastases
* Any prior malignancy (except for non-melanomatous skin cancer or in situ cervical cancer) other than the study disease, unless treated with curative intent with no evidence of disease ≤ 2 years before enrollment
* History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan
* Active inflammatory bowel disease or other bowel disease causing chronic diarrhea (defined as \> Common Terminology Criteria for Adverse Events (CTCAE version 3) grade 2
* Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment
* UGT1A1\*28 TA7/7, TA7/8, TA8/8 genetic polymorphisms; Gilbert's Disease
* Treatment with CYP3A4 enzyme inhibiting or inducing medications ≤ 2 weeks before enrollment
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
* Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (eg, bevacizumab) ≤ 30 days before enrollment
* Subjects requiring immunosuppressive agents (eg, methotrexate and cyclosporine), however corticosteroids are allowed
* Major surgery \< 28 days prior to enrollment or minor surgery (excluding catheter placement) \< 14 days before enrollment
Erlotinib Versus Carboplatin/Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

60% of all malignant diseases occur in patients who are 65 years or older. For these patients, aggressive treatments are often not suitable due to reduced life-expectancy, reduced general condition, comorbidities, and reduced vital functions which can lead to increased adverse effects of chemotherapy. Therefore, it is important to investigate alternative therapy options for elderly patients.

Erlotinib is an orally applied medication which is associated with reasonable toxicity. This targeted agent may prove an effective and well-tolerated first-line therapy in elderly patients with advanced non small cell lung cancer.

Therefore, the aim of this study is to investigate the progression-free survival of the combination of vinorelbine and carboplatin in comparison to erlotinib. Given that there will be no significant reduction of efficiency this may provide elderly patients of more than 70 years of age with an active oral substance without subjecting them to the sometimes severe adverse effect of the chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytological proven NSCLC, stage lll b (with pleural effusion) or stage lV.
* Tumour is locally advanced and not suitable for surgery and radiotherapy is not indicated.
* Neither cytostatic nor immunological pre-treatment
* Age \>70 years
* At least one measurable lesion (RECIST criteria) that was not previously irradiated
* ECOG Performance Status 0-1
* Life expectancy \> 3 month
* Adequate bone marrow function: ANC \> 1.5 x 109/L, Platelets \> 100 x 109/L
* Adequate liver function: Total Bilirubin \< 1.5 x ULN, GOT/GPT\< 3 x ULN (existent liver metastases \< 5 x ULN)
* Adequate renal function:creatinine clearance \> 45 ml/min (calculated according to Cockroft-Gault)
* Fertile men must agree to use an effective method of birth control while participating in this study
* Signed written informed consent

Exclusion Criteria:

* Uncontrolled metastasis in the CNS
* Acute, heavy uncontrolled infection
* Any other serious concomitant disease or medical condition, which could interfere with participating in this study
* Severe hypersensitivity to Erlotinib or any other component
* Hypersensitivity to Carboplatin and/or other platinum compounds
* Hypersensitivity to Vinorelbin or other Vinca-alkaloids
* Patients with a history of other active malignancy in the past 5 years (with the exception of carcinoma in situ of the cervix, non melanomatous skin cancers or local prostate carcinoma that was surgically treated successfully) are excluded.
* Participation in another clinical trial with any investigational drug at the same time or within 30 days prior to registration
* Psychological, familial, social or geographical situations limiting the compliance with the study requirements
High vs Normal Protein Diets, Resistance Exercise, Lean Mass and Strength Gains

This study evaluates the effect of different types of diets (high and normal protein) on lean and fat mass, and strength in postmenopausal women practitioners of resistance exercise. Two groups will be created: high protein (1.2 protein g/body mass/day) and normal protein (0.8 protein g/body mass/day). The same training will be performed for both groups.

Both groups will undergo the same training protocol, differing only on the protein content of the diet. The dietary assessment will be made through the 24-hour food recall, being conducted at the beginning, middle and end of the intervention. Resistance exercises for upper and lower limbs will be performed, at 70% of one repetition maximum. SPPB, tug, 6-minutes and 400 meters will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Women in the postmenopausal period (menopausal for at least one year, confirmed by laboratory diagnostic tests menopause - LH and high FSH and estradiol decreased);
* Healthy;
* Who agree to participate and sign the consent term.

Exclusion Criteria:

* The one who does not provide the necessary information for the development of the study;
* Present orthopedic limitations;
* Patients with previously diagnosed and treatment of diseases such as type II diabetes mellitus, hypertension and cardiovascular disease.
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A

The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects with severe or moderately severe hemophilia A
* A negative past medical history of a Factor VIII inhibitor
* Age greater than or equal to 12 years

Exclusion Criteria:

* A history of Factor VIII inhibitors
* Presence of a bleeding disorder in addition to hemophilia
* Known hypersensitivity to hamster protein