cyrilzakka/clinical-trials huggingface dataset:
Assessment of Food Environment and Physical Activity Opportunities in Three Neighbourhoods of Buenos Aires City

Several environmental factors have contributed to the growing pandemic of obesity. It has been described that some characteristics of food and built environment have an influence on patterns of food consumption and physical activity of people in a certain place.

We have designed a cross-sectional study to describe some aspects of the food environment (community and consumer) and the frequency, distribution and characteristics of the space available to perform physical activity in three neighborhoods of Buenos Aires city.

Three neighborhoods of Buenos Aires (with representativity), from different socioeconomic strata, will be selected by convenience to conduct this study.

The study will consist on three stages: first, the generation of the sampling frame of food stores, public and private spaces available for carrying out physical activity, and the development of a tool designed to evaluate the availability of healthy foods in supermarkets and grocery stores. Finally, a sample of those stores will be randomly selected for assessing the availability of selected foods.

In Argentina, the knowledge of the food environment is limited. We believe that the information obtained in this study will contribute to a better understanding of the subject.


Eligibility Criteria:
Inclusion Criteria:

* Stable Places and ambulant stands (only those that are located habitually in the same place) of food sale and / or drinks of any type.
* Public or private spaces destined for the accomplishment of physical activity.

Exclusion Criteria:

* Places and stands of food sale and / or drinks and spaces for the accomplishment of physical activity not opened the public in general (as those who are inside schools, places of work, centers of health, etc.)
Optimal Treatment Protocol for Selective Laser Trabeculoplasty

A randomized controlled trial to evaluate which treatment protocol in selective laser trabeculoplasty that is most optimal in terms of efficacy and safety.

A randomized controlled trial in which individuals scheduled for SLT are randomized to one of four treatment protocols, which represent the most common variants of the treatment in clinical use.

Treatment is performed either at 360 degrees or 180 degrees and with a laser energy level either 0,1 millijoules (mJ) below the microbubble formation limit ("low" energy) or at a level that gives microbubbles at 50-75% of laser effects ("high" energy). This gives four treatment arms: 180/low, 180/high, 360/low and 360/high. Group allocation is masked for the patient and is coded in the records.

The results for short and long term treatment effects are compared between the groups, as well as the complication rate and postoperative discomfort.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis primary open-angle glaucoma, pseudo-exfoliative glaucoma or ocular hypertension.
* intra-ocular pressure (IOP) at least 18 mmHg treatment day.
* treatment is performed by an experienced laser surgeon.
* SLT treatment and follow-up are expected to be possible to perform in an adequate way, considering anatomical factors, age and the general health of the patient.

Exclusion Criteria:

* change of IOP-lowering medication during the last three months.
* planned change of intra-ocular-pressure-lowering medication.
* previous glaucoma surgery (other than SLT and ALT)
* previous intra-ocular surgery during the last three months.
* previous intra-ocular inflammatory disease during the last year.
* planned intra-ocular surgery.
* hyper-pigmented anterior chamber angle.
Study to Demonstrate the Non-inferiority of Olmesartan Medoxomil Versus Candesartan Cilexetil in Reducing Blood B-type (or Brain) Natriuretic Peptide Levels at Week 24

This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24


Eligibility Criteria:
Inclusion Criteria:

* Male or female, adult, out-patients aged between 18 and 85 years
* Patients with documented hospital admission within the previous 3 months before randomization with discharge diagnosis of CHF
* Patients with functional NYHA class II-IV with LVEF \< 40% assessed within the last 3 months
* Patients with blood BNP levels \> 400 pg/ml or NT-ProBNP levels \> 1500 pg/ml
* Patients with CHF due to ischemic heart disease, idiopathic dilated cardiomyopathy (IDC), mitral or aortic insufficiency or hypertension
* Patients with stable conventional treatment with diuretics, ACEI and/or beta-blockers and/or aldosterone antagonists for at least 2 months prior to randomisation, unless documented contraindication or intolerance

Exclusion Criteria:

* Females who are pregnant or plan a pregnancy during the time of the trial, are nursing or are of childbearing potential and not using acceptable methods of contraception. If a female becomes pregnant during the study, she has to be withdrawn immediately
* Patients with current hospitalisation due to heart failure
* Patients with stroke or transient ischemic attack (TIA) within the last 3 months
* Patients with acute coronary syndrome, myocardial infarction, coronary artery bypass or angioplasty within 3 months
* Planned cardiac surgery, revascularization or resynchronization within the study period
* Patients with operable valvular disease or significant obstructive cardiomyopathy
* Patients with bradycardia \[heart rate (HR) \< 50 bpm\]
* Patients with hypotension \[systolic blood pressure (SBP) \< 90 mmHg\]
* Patients with obstructive pneumopathy
* Patients with clinical significant renal failure (creatininemia \> 200 micromol/l)
Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

The purpose of this study is to compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. During surgery, measurements of bone resection and bone-to-implant relationships will be recorded. At selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of end-stage degenerative joint disease of the knee
* must be deemed appropriate for total knee replacement surgery

Exclusion Criteria:

* severe flexion deformity of the knee
* greater than 20deg varus or valgus malalignment
* osteomyelitis, septicemia, prior infection of the knee joint
* presence of infections or highly communicable diseases
* significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity
* metastatic disease
* congenital, developmental, bone disease or previous knee surgery that may interfere with the total knee prosthesis survival or success
* previous total knee replacement in affected knee
* arthrodesis of the affected knee
Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors

The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.


Eligibility Criteria:
Inclusion Criteria: - Eligible to be PBPC donor for allogeneic transplantation as determined by local institution Exclusion Criteria: - History of splenectomy - Previous PBPC mobilization attempts - Previous treatment with GCSF or GMCSF
Effectiveness of Donor Human Milk Supplementation for the Treatment of Hypoglycemia in the Breastfed Infant

The purpose of this study is to compare if newborn infant hypoglycemia can be improved with bottle supplementation of commercially-sterilized donor human milk compared to standard infant formula. Hypothesis is that supplementation with commercially-sterilized donor human milk will improve hypoglycemia and limit formula use in exclusively breastfed infants.

Enrolled infant participants will receive a maximum of two bottle feeding supplementations (of their designated treatment arm for either 20 calorie-per-ounce commercially-sterilized donor human milk OR 20-calorie-per-ounce standard infant formula) as treatment if they meet hypoglycemia criteria. Infant participants will complete the study if 1) they have received two bottle feeding supplementations for treatment of hypoglycemia, 2) they only received one bottle supplementation and hypoglycemia resolved, 3) if the medical teams deems the infants requires a higher level of care for their hypoglycemia (example: admission to the newborn intensive care unit for intravenous fluids with dextrose).

Eligibility Criteria:
Mother-infant pairs will be consented for participation via informed written consent.

Inclusion Criteria:

* Mother/infant dyads deliverying at Nebraska Medicine hospital (Omaha, NE, USA).
* Infant in the normal newborn nursery, born greater than or equal to 36 weeks gestational age.
* Infant with blood glucose after delivery of \< 40 milligrams/deciliter within the first four hours of life OR blood glucose levels less than 45 milligrams/deciliter after four hours of life
* Deliverying mother plans to exclusively breastfeed.

Exclusion Criteria:

* Infants born and directly admitted to the newborn intensive care unit
* Infants with known congenital abnormality or known inborn error of metabolism that influences growth and metabolic outcomes
* Infants deemed ward of state
* Mothers who do not plan to exclusively breastfeed at time of delivery
* Mothers less than 19 years of age
Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer

This is a prospective Belgian, multi-center, open-label, single-arm phase II study of weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer to evaluate tumor response in the breast and the axilla.


Eligibility Criteria:
Inclusion Criteria:

* Stage II-III operable triple negative (ER and PR \< 10%; Her2 IHC 0-1 or FISH \<2.0) breast cancer in women age \> 18. For patients aged 65 or older the G8 geriatric screening test should be \> 14 (on a total of 17).
* Baseline mammography, US. MR of the breast on clinical indication.
* FNA of suspicious axillary lymph node is indicated
* Pre-treatment SN biopsy is indicated in clinical N0
* Measurable loco-regional disease
* Adequate bone marrow function, defined as

  * Absolute neutrophil count(ANC) \>1500\*109/L
  * Platelet count \>100.000\*109/L
* Adequate liver function defined as

  * Serum(total) bilirubin \<1.5\*upper limit of normal(ULN), unless the patient has documented Gilbert's Syndrome
  * AST and/or ALT \<2.5\*ULN
  * Alkaline phosphatase \<2.5\*ULN
* Normal cardiac function measured by ultrasound with a left ventricular function \> 55%
* Creatinine clearance \> 40 ml/min according to local laboratory standard (MDRD, CDK-epi, Cockroft-Gault, or other established formula to calculate renal function)

Exclusion Criteria:

* T4d breast tumor
* Bilateral breast cancer
* Other invasive cancer in the past except for a localized squamous cell cancer or basal cell of the skin or an in situ squamous cell cancer of the cervix.
* Pregnant or lactating patients
Treatment of Smoking Among Individuals With PTSD

This study will examine the effect of combining prolonged exposure, a cognitive-behavioral treatment program for post-traumatic stress disorder (PTSD) with medication (varenicline) and counseling treatments for smoking cessation. Subjects will be randomly assigned to a 3-month treatment of either: 1) varenicline and smoking cessation counseling alone, or 2) prolonged exposure, varenicline, and smoking cessation counseling. Assessments will be completed at the end of treatment and 6-month follow-up.

We hypothesize that, at the end of treatment and at follow-up, abstinence rates and decrease in cigarettes smoked will be greater among participants who receive the combined treatment for both PTSD and smoking.


Eligibility Criteria:
Inclusion Criteria:

* Male or female treatment-seeking cigarette smokers between 18-75 years old who smoke an average of ≥10 cigarettes/day during past year;
* Current diagnosis of chronic PTSD (symptom duration \> 3 months) with clinically significant trauma-related symptoms (PSS-I \>= 20)
* Live a commutable distance to the University of Pennsylvania and agree to follow-up visits;
* Agree not to use other forms of smoking cessation treatment or treatment for PTSD during the study period;
* If taking SRIs or other medications at intake, have been on stable medication and dose regimen for past 3 months and agree to maintain current regimen if possible;
* Demonstrate the capacity to provide informed consent;
* Speak and read English.

Exclusion Criteria:

* History of drug or alcohol abuse or dependence in past 3 months or any unwillingness to not smoke marijuana during the first 13 weeks of the study;
* Current and continuing intimate relationship with a physically or sexually abusive partner;
* Current suicidal ideation with intent and/or plan that, in the judgment of the investigator, should be the focus of treatment;
* Prior serious suicide attempt, as judged by the evaluator to have a high degree of lethality;
* Current or past history of psychosis (bipolar disorder or schizophrenia);
* History of significant cardiovascular disease or uncontrolled hypertension in past 6 months;
* Women who are pregnant, likely to become pregnant (i.e., sexually active and not using contraception), or nursing.
Pharmacokinetics of LCQ908 in Patients With Hepatic Impairment

This study will compare the pharmacokinetics of LCQ908 in subjects with varying degrees of hepatic impairment to healthy subjects.


Eligibility Criteria:
Inclusion criteria:

Individuals with hepatic impairment only

• Hepatic impairment evidenced by a Child-Pugh score

* Mild hepatic impairment defined Child-Pugh Class A (5-6 points)
* Moderate hepatic impairment defined Child-Pugh Class B (7-9 points)
* Severe hepatic impairment defined Child-Pugh Class C (10-15 points).

Healthy subjects only

• Good health determined.

Exclusion criteria:

All Individuals

* A past medical history of clinically significant ECG abnormalities or a family history of a prolonged QT-interval syndrome.
* Female subjects must be of non child bearing potential or use an effective method of contraception.

Individuals with hepatic impairment

* History of drug or alcohol abuse within 3 months prior to dosing.
* History or presence of significant uncontrolled disease of any major organ class.
* Any surgical or medical condition other than hepatic impairment which might alter the drug metabolism.

Healthy subjects

* History or presence of significant uncontrolled disease of any major organ class.
* Any surgical or medical condition other than hepatic impairment which might alter the drug metabolism.
* History or presence of hepatitis B or C and/or positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening.

Other protocol-defined inclusion/exclusion criteria may apply.
Two Cycles of PAD Combination by AHCT in MM

Based the proven efficacy and the ability to induce rapid response of various combinations of bortezomib including PAD combination in refractory and newly diagnosed patients with Multiple Myeloma, the investigators intend to investigate the efficacy of 2 cycles of PAD combination (Ps-341/Bortezomib, Adriamycin, and Dexamethasone) and to examine the feasibility of harvesting G-CSF mobilized PBSC and performing early AHCT after 2 cycles of PAD.

1.PAD combination chemotherapy

* Bortezomib 1.3 mg/m2 will be given by intravenous bolus injection on days 1, 4, 8, 11 of each cycle. Oral or intravenous dexamethasone 40 mg will be administered on days 1-4 and 8-11 with doxorubicin 9 mg/m2 by intravenous bolus on days 1-4 of each cycle. The cycle will be repeated every 3 weeks. A total of 2 cycles is planed before AHCT.
* For mobilization, G-CSF 10ug/kg/d alone will be given by subcutaneous injection from day 12 of the second PAD cycle until completion of harvesting.

Melphalan 100 mg/m2/day will be administered on day -3 and day -2 for high-dose chemotherapy.

-Maintenance :Thalidomide 100 - 200 mg/d for 2 years

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed symptomatic MM (see Appendix I)
* Patients should be eligible for AHCT.
* Patients should have measurable serum or urine paraprotein.
* The performance status of the patients should be 70 or over by Karnofsky performance scale
* Adequate hepatic and renal function: serum bilirubin \< 1.5 x the upper limit of normal (ULN), serum alanine aminotransferase (ALT)/aspartate aminotransaminase (AST) values \< 2.5 x ULN, serum creatinine \< 1.5 x ULN
* Adequate cardiac function: ejection fraction \> 40% by echocardiogram or radionuclide heart scan

Exclusion Criteria:

* prior chemotherapy for myeloma except 4 days of dexamethasone up to 40 mg per day or localized radiotherapy or plasmapheresis for the treatment of clinically significant hyperviscosity syndrome
* have a peripheral neuropathy of grade 2 or more within 14 days of enrollment.
* significant infection
Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?

The traditional model of localizing a nerve for blockade is using a peripheral nerve stimulator, PNS. Recent advances in UltraSound technology has allowed UltraSound to guide nerve blockade. However despite excellent visualization nerve block success has not significantly improved. I aim to show that this is because the PNS stimulation of a nerve is more than a proximity response as thought but a correct fascial plane response and hence the high success rate of this blind approach.


Eligibility Criteria:
Inclusion Criteria:

* ASA 1 to 3 patients for any shoulder surgery or unilateral ACL knee surgery

Exclusion Criteria:

* Refusal to consent
* Allergy to Chirocaine local anaesthetic
* Pace maker in situ
* Sepsis at site of regional block
Ph 2 Bortezomib, Dexamethasone, + Doxorubicin With ALCAR for Previously Treated Multiple Myeloma

Patients will receive Bortezomib, Dexamethasone, and Doxorubicin in 21 day cycles a total of 4 to 8 times (based on response to the treatment). Patients will also receive acetyl-L-carnitine (ALCAR) daily.

The primary objective of this study is to assess overall response rate to the treatment.

Secondary objectives include: evaluating and describing the incidence of chemotherapy-induced peripheral neuropathy using the FACT/GOG-Ntx assessment tool; evaluating the utility of adding ALCAR to the chemotherapy to reduce the incidence of peripheral neuropathy; and evaluating the utility of the Grooved Pegboard Completion Time as a longitudinal measure of peripheral neuropathy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with previously treated multiple myeloma with measurable serum or urine monoclonal protein.

Exclusion Criteria:

* Patients with previous doxorubicin treatment totaling 220 mg/m2 or more
* LVEF less than 45%
* Patients with \>grade II sensory neuropathy at baseline as assessed by the PI will be excluded
* No history of seizures as ALCAR may lower the seizure threshold
* Known HIV infection
* Current pregnancy.
Diagnostic Performance of Ultrasound Elastography for Detection of Thyroid Cancer

For patients with thyroid gland nodule, fine-needle aspiration biopsy has been proved to be an efficient tool for thyroid cancer diagnosis. However, it is somewhat an invasive procedure and is subject to sampling and analysis uncertainties. Thus, improved, more reliable criteria for determining which nodule should be be aspirated are needed. Ultrasound elastography has been shown to be useful in the differential diagnosis of breast and prostate cancers. Ultrasound elastography also may discriminate malignant from benign nodule.

To prospectively evaluate the elastographic appearance of thyroid cancer and explore the potential sensitivity and specificity of elastography for differentiating benign and malignant tumors, with histopathologic analysis as the reference standard.

Eligibility Criteria:
Inclusion Criteria:

- The patients with thyroid nodule who are supposed to take fine needle aspiration biopsy

Exclusion Criteria:

- The patients who do not want to participate in the study
FreeStyle Libre Flash Glucose Monitoring System Post Approval Study

This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in people with diabetes.

Up to 920 adult subjects, aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 736 subjects who complete the final visit. Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject must have a diagnosis of type 1 or type 2 diabetes mellitus.
* Subject is currently using SMBG for managing their diabetes.
* Subject must be able to read and understand English
* In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
* Subject must have access to an internet connected computer for uploading data from the blood glucose meter and FreeStyle Libre system.
* Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria:

* Subject is a member of the Site Staff.
* Subject is currently using or has previously used a continuous glucose monitoring system for managing their diabetes
* Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
* Subject is pregnant or is attempting to become pregnant at the time of enrollment.
* Subject is on dialysis at the time of enrollment.
* Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
* Subject currently is participating in another clinical trial.
* Subject is unsuitable for participation due to any other cause as determined by the Investigator.