cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of ONO-5129 in Patients With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of ONO-5129 in patients with type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

1. Fasting Blood Glucose 126-250mg/dL
2. HbA1c 6.5-11%

Exclusion Criteria:

1. Previous treatment with antidiabetic agents equal to or less than 2-3 months prior to randomization
2. History of myocardial infarction, coronary artery surgery
3. Other eligibility criteria as specified in the study protocol
A Double-Blind Group Comparative Study To Evaluate the Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients With Multiple Episodes of PCP

To evaluate and compare the safety, tolerability, and effectiveness of long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had multiple episodes of AIDS associated Pneumocystis carinii pneumonia (PCP).


Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Zidovudine (AZT).

Patients must have:

* AIDS.
* Recovered from their most recent episode of Pneumocystis carinii pneumonia (PCP). Patients must be at least 2 weeks status post therapy for acute PCP.
* Adequate pulmonary function (vital capacity = or \> 65 percent of predicted; forced expiratory volume, 1 s = or \> 55 percent of total FEV; and corrected pulmonary diffusion capacity \> 50 percent of predicted).
* Patients must be free of acute medical problems.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* AIDS-defining opportunistic infection prior to entry such as toxoplasmosis and cryptococcosis.
* Pulmonary Kaposi's sarcoma.
* Asthma poorly controlled by medication.
* Receiving active therapy for tuberculosis.

Concurrent Medication:

Excluded:

* Active therapy for tuberculosis.

Patients with the following are excluded:

* Requiring ongoing active therapy for an opportunistic infection at time of study entry.
* AIDS-defining opportunistic infection prior to study entry such as toxoplasmosis and cryptococcosis.
* Pulmonary Kaposi's sarcoma.
* Unwilling to sign informed consent.
* Asthma poorly controlled by medication.
* Unwilling to cooperate with study procedures.
* Receiving active therapy for tuberculosis.

Prior Medication:

Excluded within 30 days of study entry:

* Antiretrovirals (other than zidovudine (AZT)).
* Immunomodulating agents.
* Corticosteroids.

Prior Treatment:

Excluded within 7 days of study entry:

* Transfusion.
* Patient cannot be transfusion dependent (requiring blood transfusion more than once per month).

Active substance abuse.
Influence of Foot Types on Collegiate Athletes

The purpose of the study is to assess whether high or low arch foot types influence the overall performance of the athlete.

After meeting the eligibility criteria for the study, university athletes have their general athletic condition variables evaluated in the laboratory and in the field. Subsequently, athletes with high and low arches perform 12-week foot muscle strengthening exercises to re-evaluate the variables in both athletes with high and low arch types who performed the strengthening exercises, as well as those with neutral arch who did not perform the exercises.

Eligibility Criteria:
Inclusion Criteria:

* University athletes with 4 years of continuous training
* high foot
* low foot.
* Neutral foot

Exclusion Criteria:

* Any pain
* active injuries
* biomechanical alteration in their lower extremities.
* Spine disorders
* Spine surgery
* abdominal surgery,
* neural or vestibular disease
* arthritis of the lower extremities
* used of alcohol, sedatives, pain relievers, cold medication, or stimulants in the last year
* rigid pronated foot
Palatability and Tolerability of Deferasirox Taken With Meals, With Different Liquids or Crushed and Added to Food

This single-arm, open-label, multi-center study enrolled 65 patients from approximately 20 centers. All patients who met the study criteria and were taking, beginning or resuming treatment with Deferasirox were allowed. The study will began with a one month run-in phase, where all patients were instructed to take Deferasirox according to their physician's prescribing information.

Following the run-in phase, patients entered a three month, assessment phase. During the assessment phase, patients were given five general options for taking Deferasirox including with or without meals, crushed and added to a soft food or mixed in a liquid of choice.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with thalassemia major, sickle cell disease (SCD), low or intermediate 1 (INT 1) risk myelodysplastic syndrome (MDS) or other anemias and transfusional hemosiderosis.
* Patients who were on, starting, or resuming treatment with Exjade.
* Patients who were \>2 years (i.e., 2 years of age or older).

Exclusion criteria:

* Serum creatinine above the upper limit of normal (ULN) for age.
* Alanine aminotransferase (ALT) \>2.5 times the ULN.-High risk intermediate-2 or high risk MDS or acute leukemia.
Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection

Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.

Laparoscopic sleeve gastrectomy (LSG) provides similar weight loss and resolution of obesity comorbidities to that of duodenal switch and Roux-en-Y gastric bypass. Inspite of its encouraging results, the pretended feasibility of the operative procedure can be associated with a remarkable operative morbidity. The main reason is gastric leakage from stable line which occurs in about 0-20% of the cases. The main accepted cause of leakage is formation of a high gastric tube pressure. Injection of BTX-A into the pyloric sphincter intraoperative will cause temporal paralysis of pyloric sphincter muscles postoperatively; so the pressure inside the gastric pouch will be decreased abolishing the formation of high pressure tube with subsequent leakage.

Eligibility Criteria:
Inclusion Criteria:

Body mass index \>40 or \>35 with hypertension or DM

Exclusion Criteria:

Previous bariatric surgery
Comparison of Manual Therapy Versus Radial Shock Waves in the Shoulder Pain Treatment

Subacromial syndrome represents the third leading cause of pain in the general population. There is no clear pathophysiological explanation, nor a specific treatment. Manual therapy stands out as one of the reference treatments for this disease, however, it is complex to develop a specific protocol. On the other hand, shock waves have still not received adequate attention in the treatment of this pathology. The aim of this study will focus on using manual treatment using ischemic pressure, joint mobilizations and myofascial techniques in comparison to shock wave therapy to determine which is more effective.

This study will be a randomized, single-blind clinical trial with third-party evaluation. In it 88 subjects suffering from subacromial syndrome will participate. 44 patients will receive treatment through manual therapy over 6 weeks and other 44 patients through low-med energy radial shock waves for 6 weeks.

All subjects will complete their treatment with a 12-week home-based therapeutic exercise program.

The main endpoint of the study will be pain measured using the visual analogue scale (VAS) in motion. Pain will also be assessed using the VAS scale at rest and overnight. The Spadi Spanish version questionnaire will be used, shoulder strength will be measured using a handheld dynamometer and the ranges of motion will be measured.

Data will be measured before and one year after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral shoulder pain with no history of trauma.
* Pain of at least 4/10 on the Visual Analogue Scale for a minimum period of 3 months.
* Be positive in at least 3 of the following 5 tests: painful arc test, Neer impingement test, Hawkins-Kennedy test, Jobe test, external rotation test against resistance for the infraspinatus tendon.

Exclusion Criteria:

* Presence of red flags.
* Diagnosis of shoulder instability.
* Diagnosis of frozen shoulder.
* Diagnosis of complete rupture of the common rotator cuff tendon.
* Diagnosis of cervical radiculopathy.
* Diagnosis of whiplash.
* Diagnosis of degenerative disease of the glenohumeral joint.
Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways

The purpose of this study is to determine whether the use of clinical pathways improves the quality of the hospital care of decompensated heart failure patients.

In Europe approximately 5% of all acute medical admissions relate to heart failure and in the United States heart failure is responsible for almost 1 million hospitalizations annually. Almost three quarters of these admissions are unplanned and worsening heart failure is responsible for half of these admissions.

The Acute Decompensated Heart Failure National Registry (ADHERE) showed that the hospital treatment of heart failure frequently does not follow published guidelines or conform to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) core performance measures, potentially contributing to the high morbidity, mortality and economic cost of this disorder. ADHERE findings also suggested that the wide variations in conformity may reflect differences in training, guideline familiarity, and implementation of tools and systems to ensure that recommended care is provided and documented. Consequently the development of educational and quality improvement programs has the potential to considerably reduce the current variability in care, enhance guideline adherence, and improve outcomes for patients.

Clinical pathways has become a popular tool to achieve such goals. Clinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period with the aim to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. They are also developed by multi-professional teams. Despite enthusiasm and diffusion, the widespread acceptance of clinical pathways remain questionable because very little prospective controlled data demonstrated their effectiveness.

The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was designed in order to conduct a rigorous evaluation of a clinical pathway in hospital treatment of decompensated heart failure.

Eligibility Criteria:
Inclusion Criteria:

* principal diagnosis of heart failure (all ICD-9 codes included in 428.xx code)

Exclusion Criteria:

* current acute myocardial infarction (AMI)
* current unstable angina
Duke Urology Database and Specimen Bank

The proposed project is aimed to build a Duke University-specific longitudinal urologic surgery database. It will be used as the main resource to support future research within Urology and Duke University.

Specifically, the database will be used for the following future studies. (i) To characterize the biomarkers/protein signature associated with urological diseases; (ii) To clarify the clinical role of the risk factors and their interactions for early detection and optimized treatment of urological diseases, and improvement of post-treatment quality of life; (iii) To develop algorithms and nomograms to accurately predict the outcome of urological diseases.

Retrospective review of subjects data prior to Institutional Review Board approval and prospective review of data on those consented after Institutional Review Board approval.

Eligibility Criteria:
Inclusion Criteria:

* Duke Urology patients

Exclusion Criteria:

* None
Convergent Validity of DABQ Questionnaire

Time-use epidemiology is a rapidly growing research area that aims to understand how individuals allocate their time to various activities throughout the day. Accurate assessment of daily activity behaviors, such as sleep, sedentary behavior (SB), light physical activity (LPA), and moderate to vigorous physical activity (MVPA), is crucial for studying the associations between activity patterns and health outcomes. To gather this information, researchers often rely on self-report questionnaires and objective measures, such as accelerometers, to provide a comprehensive understanding of individuals' activity levels.

Recently, a validated questionnaire known as the Daily Activity Behavior Questionnaire (DABQ) has been developed. In a study comparing DABQ estimates with the activPAL4 accelerometer (as the reference method), good results regarding absolute agreement and consistency were obtained for sleep duration (ICC 0.6), while the absolute agreement and consistency for SB, LPA, and MVPA estimates was lower (ICC ranging from 0.22-0.47).

It should be noted that this study acknowledges the limitation of not treating the data as compositional data. Compositional data analysis accounts for the relative distribution of different activities and avoids the assumption of independence between behaviors. Additionally, the activPAL4 accelerometer used as the reference method in the study had its own strengths and weaknesses when compared to other objective measures, such as the Actigraph. Where ActivPAL4 is more used to differentiate between sitting and standing, Actigraph is able to better classify activity intensities. Moreover, as recommended in different research, I use the Actigraph in my PhD to objectively asses 24-hour movement behaviors.

Given these considerations, the aim of this study is to validate the DABQ against the Actigraph as the reference method. Furthermore, this study aims to analyze the data as compositional data, which would provide a more comprehensive understanding of the interrelatedness of behaviors. The hypothesis is that there will be moderate convergent validity between the DABQ and Actigraph, allowing for accurate assessment of sleep duration, SB, LPA, and MVPA. By establishing the validity of the DABQ and considering the data as compositional, researchers can utilize this questionnaire in time-use epidemiology studies, which could be seen as an easy to use and cost-effective measurement method.


Eligibility Criteria:
Inclusion Criteria:

- Adults between 18 and 65 years old

Exclusion Criteria:

* Physical (e.g. amputations, paralysis, recovering from stroke, osteoarthritis conditions that obstruct daily functioning
* Cognitive (e.g. dementia, psychological disorders) conditions that obstruct daily functioning
* Major medical (e.g. Chronic respiratory diseases, heart failure, cardiovascular diseases) conditions that obstruct daily functioning
Use of Hyperbaric Oxygen Therapy to Improve Umbilical Cord Blood Stem Cell Homing and Subsequent Engraftment

By doing this study, researchers hope to learn the following:

* If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC) transplant will help to improve the homing process
* The safety of HBO administration in the setting of the UBC transplant
* The effects of HBO therapy on the engraftment process

Research has suggested that high levels of erythropoietin (EPO) decreases the ability of infused umbilical cord stem cells to home to the bone marrow. The investigators will investigate the use of hyperbaric oxygen (HBO) therapy to decrease the plasma concentrations of EPO prior to UBC transplant and evaluate the resulting impact on UBC homing.

Eligibility Criteria:
Inclusion Criteria:

* Voluntary written informed consent
* Subjects must be \>/= 17 yrs and \</= 70 yrs for non-myeloablative transplant
* Subjects must be \>/= 17 yrs and \</= 55 yrs for myeloablative transplant
* Subjects with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL) who are considered for UCB transplant
* Use of approved form of contraception
* Karnofsky performance status of \>/= 70%
* Adequate hepatic, renal, pulmonary and cardiac function. Criteria include:
* ALT (alanine aminotransferase), AST (aspartate aminotransferase: \< 4x IULN (institutional upper limit of normal)
* Total bilirubin \</= 2 mg/dL
* Serum creatinine \< 2.0 mg/dL
* Left ventricular ejection fraction \>/= 45%
* FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD (diffusing capacity of lung for carbon monoxide) \>/= 50% of predicted value (corrected to serum hemoglobin)

Exclusion Criteria:

* Pregnancy or breast feeding
* Severe chronic obstructive pulmonary disease requiring oxygen supplementation
* History of spontaneous pneumothorax
* History of seizures
* Claustrophobia
* Asthma
* Uncontrolled viral or bacterial infection at the time of enrollment
* Active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval
ROBUST I Pilot Study, Re-Establishing Flow Via Drug Coated Balloon For The Treatment Of Urethral Stricture Disease

Robust I study is a feasibility study for evaluating the safety and efficacy of DCB.

The study is designed to determine the safety and effectiveness for drug coated balloon (DCB).

Up to 50 subjects is planned to be enrolled and treated with the study device at up to 5 clinical sites outside of US. Due to significantly higher prevalence of strictures in men vs. women and the etiology of those strictures being different, the study will focus on male subjects with single anterior urethral stricture. Subjects will be followed up post-treatment to one year and then annually for up to 5 years. The annual follow up after the first year is optional.

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects ≥ 18 years' old
2. Visual confirmation of stricture via cystoscopy or urethrogram
3. Single lesion anterior urethral stricture or bladder neck contracture, less than or equal to 2.0 cm
4. One to three (1-3) prior diagnosis and treatment of the same stricture (including self-catheterization) including DVIU (Direct Vision Internal Urethrotomy), but no prior urethroplasty
5. Significant symptoms of stricture such as frequency of urination, dysuria, urgency, hematuria, slow flow, feeling of incomplete emptying, recurrent UTI's.
6. IPSS score of 13 or higher
7. Lumen diameter \<12F by urethrogram
8. Able to complete validated questionnaire independently
9. Qmax \<10 ml/sec

Exclusion Criteria:

1. Strictures greater than 2.0 cm long.
2. Subjects that have more than 1 stricture.
3. Sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
4. Subjects who have a suprapubic catheter and are unable to complete study required testing, such as uroflowmetry
5. Previous urethroplasty within the anterior urethra
6. Stricture due to bacterial urethritis or untreated gonorrhea
7. Stricture dilated or incised within the last 3 months
8. Presence of local adverse factors, including abnormal prostate making catheterization difficult, urethral false passage or fistula.
9. Presence of signs of obstructive voiding symptoms not directly attributable to the stricture such as BPH at the discretion of the clinical investigator
10. Previous radical prostatectomy
11. Previous pelvic radiation
12. Diagnosed kidney, bladder, urethral or ureteral stones or active stone passage in the past 6 months.
13. Diagnosed with chronic renal failure unless under hemodialysis or has a serum creatinine level greater than 2 mg/dL
14. Use of alpha blockers, beta blockers, OAB (Overactive Bladder) medication, anticonvulsants (drugs that prevent or reduce the severity and frequency of seizures), and antispasmodics where the dose is not stable. (Stable dose is defined as having the same medication and dose in the last six months.)
15. Use of Botox (onabotulinumtoxinA) in urinary system within the last 12 months
Prevention of Acute Mountain Sickness by Intermittent Hypoxia

Acclimatization by mountaineering prior to high altitude sojourns have shown to be effective in prevention of acute mountain sickness (AMS).

The aim of this study is to investigate whether intermittent exposure to normobaric hypoxia during sleep is also effective to prevent AMS.


Eligibility Criteria:
Inclusion Criteria:

* healthy

Exclusion Criteria:

* Altitude exposure above 2000 m 8 weeks prior or during the study
Busulfan Pharmacokinetic Analysis and GST Pharmacogenetic Profile in Adults Undergoing Hematological Stem Cell Transplantation

The correlation between Busulfan Pharmacokinetics in AML transplanted patients and their GST (A1,T1,M1 and P1), MDR-1 genetic profile. If a pre-genetic testing of those genes can be utilized as biomarkers of SOS and/or HGVHD. This study is not an interventional study it is only checking the GST gene and MDR-1 gene

BU levels are largely unpredictable, patients are often exposed to the toxic effects of inappropriate drug regimens before dose modifications can be made. Although the importance of TDM cannot be over emphasized, it entails trial and error and does not allow for pre- treatment dose optimization. This study, which provides an integration of genetic and pharmacokinetic data analysis of patients preconditioned for HSCT with high dose oral BU, aims to define biomarkers predictive of poor BU metabolism and clearance to prevent potential drug toxicity.This study is not an interventional study, only investigates the GST and MDR-1 genes in correlation with the "routine" Busulfan AUC done during the preparative regimen in HSCT for AML patients.

Eligibility Criteria:
Inclusion Criteria:

* Acute Myeloid Leukemia who are clinically selected for HSCT according to known protocols.

Exclusion Criteria:

* Unable to give informed consent
COMO: Cognition Study With HIV+ Patients (CTNPT 015)

The purpose of this study is to contribute evidence towards the potential to improve cognition in HIV+ individuals experiencing cognitive decline through personalized change in antiretroviral (ARV) medication. To that end, following a comprehensive evaluation to identify confounding clinical conditions, study participants will undergo a lumbar puncture to: (i) measure viral load (at 2 copies/ml); (ii) identify Cerebrospinal Fluid (CSF) genotype and tropism; and (iii) measure concentration of antiretroviral agents. When indicated from the CSF analysis, a personalized change in ARV will be implemented. Cognition will be measured in all at study entry and 6 months later.


Eligibility Criteria:
Inclusion Criteria:

* are 18 years and older
* have the capacity to give informed consent as determined by the research nurse
* have unexplained cognitive decline (reported either by the patient or an outside informant)
* have been on a stable ART regimen for \> 6 months
* have an undetectable viral load in plasma for at least 6 months (a single blip of ≤ 150 copies/mL will be accepted)
* have not had a change in medications that could potentially interfere with cognition in the past 4 months

Exclusion Criteria:

* detectable VL in the plasma
* past history of dementia
* past history of Central Nervous System opportunistic infection or stroke
* current substance abuse ( as per DSM-IV criteria) other than cigarettes
* coagulopathy
* thrombocytopenia
* use of Coumadin
* intra-cranial hypertension