cyrilzakka/clinical-trials huggingface dataset:
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Exercise in Adults With Type 1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

The objective is to compare the efficacy of single-hormone closed-loop strategy and dual-hormone closed-loop strategy at regulating glucose levels during continuous exercise and interval exercise.

The investigator hypothesized that dual-hormone closed-loop strategy is superior to single-hormone closed-loop strategy in regulating glucose levels during exercise periods.

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.

We aim to conduct a randomized two-way cross-over trial comparing single-hormone closed-loop strategy and dual-hormone closed-loop strategy to compare the two interventions during exercise periods in adults with type 1 diabetes. A moderate intensity exercise will be performed for 60 minutes at 60% of the maximum oxygen consumption (VO2max). A high intensity exercise will be 40 minutes of interval training. The interval training will be preceded by a 10 minutes warm-up and followed by a 10 minutes cool down.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years of old.
* Clinical diagnosis of type 1 diabetes for at least one year.
* The subject will have been on insulin pump therapy for at least 3 months.
* Last (less than 3 months) HbA1c ≤ 12%.

Exclusion Criteria:

* Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
* Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
* Ongoing pregnancy.
* Severe hypoglycemic episode within two weeks of screening.
* Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
* Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
* Problems with venous access
Vision Improvement for Patients With Age-Related Macular Degeneration

This study is being conducted to assess the safety and efficacy of the VIS, LLC (VIS) Opti-K Low Vision Aid Device and treatment to provide vision improvement to patients with age-related macular degeneration.

This study is being conducted to assess the safety and efficacy of the VIS, LLC (VIS) Opti-K Low Vision Aid Device and treatment to provide vision improvement to patients with age-related macular degeneration.

Eligibility Criteria:
Inclusion Criteria:

Subjects who meet all of the following criteria are candidates for this study:

1. Male or Female
2. Any race
3. Patient is at least 50 years old.
4. Patient has diagnosed end stage dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination.
5. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
6. Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated.
7. Patient has moderate to severe vision impairment due to age-related macular degeneration with best spectacle-corrected distance visual acuity (CDVA) of 20/80 or worse (decimal less than or equal to 0.25; logMAR ≥ 0.60).in the better eye.
8. Patient has CDVA of 20/400 or better (decimal greater than or equal to 0.05; logMAR ≤ 1.30) in the worse eye.
9. Patient is not a contact lens (CL) wearer.
10. Patient is willing and able to comply with all examinations.
11. Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria:

Subjects who meet any of the following criteria are to be excluded from this study:

1. Corneal disease or corneal disorder in either eye.
2. Pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola.
3. Gonzalez-Markowitz chart Potential Visual Acuity (PVA) in the eye to be treated that is not improved by at least four lines compared to CDVA;
4. Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma;
5. Previous corneal surgery in the eye to be treated; and
6. Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or that may confound the outcome of the study.
Cord Blood Transfusion In Preterm Neonates (CB-TrIP)

Repeated transfusions have been associated with very poor outcome of preterm infants. Fetal hemoglobin (HbF) and adult Hb (HbA) have different affinity for oxygen. The high level of adult Hb may contribute to exacerbating the oxidative damage responsible for prematurity diseases. The investigators hypothesized that transfusing red blood cells (RBC) obtained from allogeneic cord blood (CB) of healthy full-term babies (which contains almost exclusively HbF) may prevent the non-physiological decrease of HbF in premature neonates, likewise protecting them from oxygen radical diseases. Cord blood transfusion in preterms - CB TRIP - is a monocentric prospective nonrandomized study aimed to monitor HbF levels in preterm neonates receiving RBC transfusions from either umbilical blood of full-term healthy babies (CB-RBC) and/or from adult donors (A-RBC).

Preterm neonates enrolled in this study are monitored for the level of HbF on capillary blood samples, from birth to the week 32 of postmenstrual age (PMA). To fulfill the RBC transfusion requirements, RBC concentrates obtained from umbilical blood of full-term healthy babies are utilized, if available; otherwise, RBC concentrates from adult donors are assigned. For every week of PMA, neonates undergo a minimum of three HbF determinations, and the median values are considered.

Eligibility Criteria:
Inclusion Criteria:

preterm neonates born at PMA ≤30 weeks and/or with birth weight ≤1000 g born at the delivery room of Fondazione Policlinico Universitario A. Gemelli candidate to receive one or more RBC unit transfusion.

Exclusion Criteria:

One or more of the following criteria Maternal-fetal immunization Hydrops fetalis Major congenital malformations associated or not with genetic syndromes Previous transfusions Hemorrhage at birth Congenital infections (such as infections from TORCH complex) Out-born infants The health care team deems it inappropriate to approach the infant's family for informed consent
Curian S. Pneumo/Legionella Assay Beta Clinical Trial Protocol

Beta trial to evaluate the preliminary clinical performance of the Curian S. pneumo/Legionella assay for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.

This study will evaluate the preliminary clinical performance of the RUO Curian S. pneumo/Legionella assay against two FDA cleared comparators for its use in the qualitative detection of Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 antigens in human urine specimens.

Eligibility Criteria:
Inclusion Criteria:

* Adult males and females, with symptom of pneumonia and for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has been ordered by a practicing physician.
* At least 2mL of urine from fresh de-identified clinical specimen from standard of care lab testing
* Only one (1) specimen per patient will be included in the study
* Materials used within their expiration date
* Storage time and conditions within requested indications listed on RUO Package Insert

Exclusion Criteria:

* Specimens from patients for whom a Streptococcus pneumoniae and/or Legionella pneumophila serogroup 1 diagnostic test has not been ordered
* Storage times and conditions that exceed these study protocol requirements listed on RUO Package Insert
* Urine samples provided in unsatisfactory conditions
Retrospective Chart Review of Valstar

This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.

Initial treatment for bladder CIS is TURBT followed by intravesical immunotherapy with BCG. Valrubicin is approved by the FDA for the treatment of BCG-refractory bladder CIS in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. The recommended course of therapy is 6 doses of 800 mg each administered intravesically once a week. While the benefit risk profile of valrubicin has been established in several clinical trials, current data on effectiveness and tolerability when used in clinical practice are lacking. This protocol outlines a retrospective study to evaluate the effectiveness, safety and tolerability of intravesical valrubicin in the treatment of NMIBC in a clinical practice setting.

Eligibility Criteria:
Inclusion Criteria:

* age 18 years old or greater
* diagnosis of CIS (physician defined in the medical record)
* treated with at least one IVe dose of valrubicin since 10/2009 and completed prescribed therapy or no longer receiving therapy at time of study enrollment
* willing and able to provide informed consent (unless waiver of informed consent is applicable and in place at that clinical site per Chapter 45 CFR part 46 Subpart A 46.117

Exclusion Criteria:

* route of administration of valrubicin other than intravesical
Therapeutic Efficacy of Phytosterols on Metabolic Syndrome

The objective is to evaluate therapeutic efficacy of 2 grams nano-phytosterols daily supplemention on diagnosis criteria of metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent written
* Available subjects to follow-up visits
* Subjects with diagnoses of metabolic syndrome 5 years ago or with current diagnoses criteria
* Subjects with health visits ongoing
* Subjects with arterial hypertension under control.
* Subjects with mellitus diabetes under control.

Exclusion Criteria:

* Subjects with alcoholism history.
* Subjects with history of sitosterolemia.
* Subjects with familiar hypercholesterolemia
* Subjects who are consuming phytosterols
* Pregnancy women
* Breastfeeding period women
* Subjects with personal history of: acute miocardical infarction, stroke, hypertensive emergency, acute or chronic diabetes descompensation
Group Size in Basic Life Support (BLS) Courses

Basic Life Support (BLS) is important for outcome in cardiac arrest.Therefore, it is crucial to improve the quality of education in resuscitation training. Better training will eventually lead to more effective CPR skills in course participants. BLS courses in both international resuscitation associations (European Resuscitation Council and American Heart Association are typically taught in small groups of 6 participants. In reality group sizes of up to 10 participants are used, because these courses are highly demanded and cost intensive. There is no evidence for the effective group size to be clinical and cost effective. Therefore the investigators perform this prospective study to determine the maximum number of participants an instructor can oversee without missing more than 20% of errors made during an instructional BLS session.


Eligibility Criteria:
Inclusion Criteria:

* Active BLS- Instructors at the Bern Simulation and CPR-Center (BeSiC), at the Bern University Hospital, Bern, Switzerland

Exclusion Criteria:

* Decline to participate
Biliary Drainage Preceding Possible Pancreaticoduodenectomy. Are Self-expandable Metallic Stents (SEMS) Superior to Plastic Stents?

This study looks in to the rate of biliary stent dysfunction for plastic and metallic stents in patients who need biliary drainage due to a tumor in pancreas before possible pancreaticoduodenectomy. Complications related to the biliary decompression, and possible post-surgical complications in all patients are also recorded.

This trial aims to confirm whether metallic biliary stents really are superior to plastic stents as some previous studies suggest. Specific patient groups are also evaluated individually to see, whether patients with ongoing cholangitis at the time of diagnosis or patients receiving neoadjuvant treatments have less stent dysfunction cases and complications with metallic stents than with plastic stents.


Eligibility Criteria:
Inclusion Criteria:

* Resectable tumor of the head of the pancreas
* Elevated serum bilirubin levels
* Radiologically visible dilatation of the biliary system

Exclusion Criteria:

* Distant metastasis
* Inoperable tumor or other reason, why the patient is unfit for surgery
A Trial to Investigate the Effectiveness of Testosterone Treatment in Men With Multiple Sclerosis

This is a multicenter, prospective, placebo-controlled, double-blind randomized Phase II clinical trial assessing the effect of testosterone treatment vs. placebo treatment for 96 weeks duration on whole brain atrophy in men with MS.


Eligibility Criteria:
Inclusion Criteria: Men, aged 18-60, with a diagnosis of multiple sclerosis by 2010 revised McDonald Criteria
Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions

It is unclear whether different modes of continuous renal replacement therapy (CRRT) impact post-filter ionized calcium concentrations during regional citrate anticoagulation (RCA) when using calcium-containing replacement fluid.

This prospective, single-center, observational cohort study will screen all patients receiving CRRT for eligibility. General clinical information will be collected before commencing CRRT treatment. Patients will be randomly assigned to either the veno-venous hemofiltration (CVVH) or continuous veno-venous hemodialysis (CVVHD) group and switch to the alternative mode in the subsequent treatment session. Pre-filter and post-filter ionized calcium, systemic total and ionized calcium, and effluent total and ionized calcium will be measured 2 hours after the initiation of CRRT. Electrolyte levels, arterial blood gases, hourly citrate dose, and total citrate dose will be recorded every 6 hours until the end of CRRT. The primary outcome is the difference in ionized calcium concentrations at each site over time between the two modes.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old;
2. Receiving citrate anticoagulation;
3. Obtain Informed consent from patients or next of kin.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Allergic to citrate anticoagulants;
3. Severe liver dysfunction (total bilirubin levels exceeding two times the normal range);
4. Hypoxemia (PaO2 \< 60 mmHg);
5. Inadequate tissue perfusion (blood pressure \< 90/60 mmHg despite high doses of vasoactive agents);
6. Hyperlactatemia (lactate\> 4 mmol/L);
7. Hypernatremia;
8. Estimated length of hospital stay \< 48h;
9. Participated in other studies.
Abilify as an Adjunctive Treatment for Refractory Depression

This is a study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.

This is a pilot study of the effectiveness of adding Abilify (aripiprazole), an atypical antipsychotic medication, to ongoing selective serotonin reuptake inhibitor (SSRI) antidepressant treatment for depressed outpatients who are not responding fully to SSRI treatment alone. Fifteen subjects will be given aripiprazole in a flexible dosing schedule and followed for 12 weeks, while continuing their ongoing SSRI medication. Assessments of depressive symptoms, overall functioning, social functioning, and side effects will be completed. It is hypothesized that patients' functioning will improve after 12 weeks of treatment with Aripiprazole and SSRI medication.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients between the ages of 18 and 70.
* Patients with a principal Diagnostic and Statistical Manual fourth edition (DSM-IV) diagnosis of Major Depressive Disorder, unipolar, nonpsychotic type
* Patients with a total of 14 or higher on the 17-item Hamilton Depression Scale at baseline
* Patients who have had treatment with an SSRI at an adequate dose (see Table for a minimum of 6 weeks (i.e. 6 wks at the dose defined as adequate in Table 2)
* Patients who agree to use acceptable method of birth control throughout the study

Exclusion Criteria:

* Patients with any of the following DSM-IV diagnoses: Delirium, Dementia, Amnestic, or other Cognitive Disorders. Bipolar Disorder or cyclothymia, Schizophrenia, Delusional (Paranoid) Disorders and Psychotic Disorders not elsewhere classified, Severe Borderline Personality Disorder, Anorexia Nervosa, or Bulimia.
* Patients who, within the past 6 months, met DSM-IV criteria for abuse of or dependence on any drug, including alcohol.
* Patients who are pregnant or nursing women.
* Patients who would pose a serious risk for suicide during the course of the study, as evidenced by one of the following: (a) report of having a specific plan for killing themselves, (b) a score of 3 or higher on the Hamilton Depression Rating Scale item #3 as rated by the treating clinician at Week 0, or (c) a suicide attempt within the last 6 months which required medical attention, such as an emergency room visit or which is considered by the treating physician to have been possibly life threatening
* Patients with unstable medical conditions such as untreated or uncontrolled hyperthyroidism, hypothyroidism, hypertension (defined as blood pressure\>150/90), cardiovascular disease, diabetes, HIV (by report of patient).
* Patients with a history of seizures.
MassCONECT (Massachusetts Community Networks to Eliminate Cancer Disparities Through Education) 4 Kids: Promoting Smoke-free Homes

This study evaluates the effectiveness of a motivational interviewing intervention with families with young children ages 0-5 where smoking is happening in the home to adopt a smoke-free home plan and reduce child's second-hand smoke exposure.

Involuntary secondhand smoke (SHS) exposure in homes is an entirely preventable public health threat that disproportionately burdens young children in communities of low socioeconomic position. Breathe Free For Kids is a community-based participatory research (CBPR) initiative to evaluate the effectiveness of Ml compared with usual best practices (UBP) by having parents voluntarily adopt smoke-free home policies to protect children from SHS. The Motivational Interviewing intervention protocol was developed in conjunction with community partners, integrated into a health department-sponsored home visiting program for high-risk children and other community-based agencies serving children, and delivered by trained community health workers.

Eligibility Criteria:
Inclusion Criteria:

* Tobacco smoking occurs regularly (smoke a minimum of one cigarette/cigar per day or five cigarettes/cigars per week) inside the home or in an attached patio/porch, hallway or stairwell
* Primary caregiver of child aged birth to 5 years old (inclusive) enrolled in Massachusetts Early Intervention program, Healthy Families program or the general population in Boston, Lawrence and Worcester areas.
* Ability of a custodial parent aged 17 or older/legally authorized representative or primary caregiver of child enrolled in participating programs to give permission for the index child to provide saliva sample.
* Participant has access to a telephone to schedule study contacts and participate in follow-up calls

Exclusion Criteria:

* Not able to understand English or Spanish at a 8th grade level or above
* In poor physical or psychological health (self-reported and observed by Community Health Worker), for whom participating in this intervention study might compromise the child's or participant's welfare, or be impracticable
* Index child is a ward of the state
Performance of MicroTextured Dental Implants

The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar.

The investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.

Zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.

Eligibility Criteria:
Inclusion Criteria:

1. Be a current registered University of Alabama at Birmingham (UAB)dental school patient
2. Existence of one or more missing teeth scheduled to be replaced with dental implants
3. Healthy enough to undergo proposed therapy without compromising existing health
4. Able to consent for their own inclusion
5. Able to read and understand the informed consent form
6. Demonstrated willingness to comply with protocol requirements and timeline

Exclusion Criteria:

1. Any health condition that in the opinion of the investigators may adversely affect bone healing
2. Any medication that in the opinion of the investigators may adversely affect bone healing
3. Any indication of an inability to make autonomous decisions
4. Reported pregnancy at the time of enrollment -