cyrilzakka/clinical-trials huggingface dataset:
Hypotension Prediction Effect on AKI

It is a single-center randomized controlled trial that aims to figure out the effect of the hypotension prediction index (HPI) on the prevention of acute kidney injury (AKI) after radical cystectomy. The primary hypothesis is that HPI software guidance prevents postoperative AKI by reducing the duration and severity of intraoperative hypotension (IOH).


Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 19
* Patients undergoing radical cystectomy with neobladder reconstruction
* Patients undergoing radical cystectomy with ileal conduit urinary diversion

Exclusion Criteria:

* Unable to voluntarily give consent
* Unable to use both radial arteries due to such reasons: prior surgery on the radial artery, breast cancer history with axillary LN dissection, AV fistula for renal replacement therapy, or abnormal Allen's test.
Lymphedema Following Hand/Wrist Surgery in Women Post Axillary Node Dissection

This is a prospective, randomized, equivalence trial designed to evaluate postoperative complications following hand surgery with a brachial tourniquet and without a tourniquet in patients that have previously had a mastectomy with axillary node dissection with or without radiation treatment or history of lymphedema.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of ipsilateral mastectomy with lymph node dissection with or without radiation treatment.
* Patients ages 18 and over
* Patients who have failed conservative, nonoperative treatment and present for an elective hand procedure with an anticipated tourniquet time of \< 20 minutes.
* The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study.

Exclusion Criteria:

* Patients that are not postoperative mastectomy with lymph node dissection with or without radiation treatment
* Patients under the age of 18
* Patients who are pregnant
* Patients presenting for an elective hand procedure with an anticipated tourniquet time of \> 20 minutes.
* Patients who are on a blood thinner which cannot be stopped prior to surgery
* The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements.
The Effect of a Short Educational Program on Young Women's Knowledge and Beliefs About Osteoporosis

The purpose of the study is to determine the effect of a short educational program on young women's knowledge and beliefs about osteoporosis. They hypothesis is that following the intervention women who receive the educational program will have greater knowledge and beliefs about osteoporosis.

Objective. To determine the effect of a short osteoporosis educational program on young women's knowledge and beliefs about osteoporosis. Methods. Ten college physical activity classes enrolling 133 predominantly Caucasian women (age range 18 to 21 years) were randomized to an osteoporosis educational program or control. Knowledge and beliefs about osteoporosis were assessed at baseline and at one week and three weeks following the intervention using the Multiple Osteoporosis Prevention Survey. Knowledge was defined as the ability to identify correctly osteoporosis risk factors. Beliefs were measured with the use of a five point Likert type scale. The educational program was comprised of a lecture and printed materials developed by the National Osteoporosis Foundation. Chi-square and analysis of variance evaluated for between group differences. Alpha was set at 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Women enrolled in a mid-atlantic college physical activity course

Exclusion Criteria:

* Unable to partake in three survey's and one educational lesson
Retrospective Chart Review to Assess Outcomes in Subjects That Received MAGNIFUSE® in the Posterolateral Lumbar Spine

The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.


Eligibility Criteria:
Inclusion Criteria:

A subject's medical record must contain the following for the subject to be included:

1. Posterolateral surgical procedure using MAGNlFUSE with local autograft and/or iliac crest bone graft at one or two continuous lumbar levels from L1-S1.
2. Radiographs available for fusion assessment by clinician at 12 and/or 24 month post-surgery visits.
3. Subject must be at least 18 years old at the time of index procedure.

Exclusion Criteria:

The subject data will be excluded from this study if the medical record indicates:

1. Additional surgical treatment adjacent to the initial lumbar levels treated per Inclusion Criterion 1.
2. Infection at index level(s) at time of surgery.
3. Extant tumor (evident at any level), spinal metastasis, or spinal tumor at the time of surgery.
4. Pregnant at time of surgery.
5. Surgery is due to trauma (e.g., motor vehicle accident or high impact fall).
6. Use of growth factors or growth peptide (BMP2, BMP7, or iFactor) in the index-level fusion surgery.
7. Procedure is a revision surgery for previously failed fusion at the surgery index level(s).
8. Subjects with body mass index \> 40 at the time of surgery.
Sputum Cytology in Screening Heavy Smokers For Lung Cancer

RATIONALE: Screening tests, such as sputum cytology, may help doctors find tumor cells early and plan better treatment for lung cancer.

PURPOSE: This phase II trial is studying how well sputum cytology works in screening heavy smokers for lung cancer.

OBJECTIVES:

Primary

* Classify annual sputum samples cytologically in participants with or without airflow obstruction and a heavy smoking history.
* Correlate sputum cytological atypia (moderate atypia or worse) with lung cancer incidence in these participants.
* Correlate changes in sputum cytology (i.e., changes toward higher grades of atypia) with lung cancer incidence in these participants.

Secondary

* Determine other risk factors for lung cancer (e.g., diet, family history, smoking history, and medications) that may either confound or modify the association between sputum cytology and lung cancer risk in these participants.

OUTLINE: Two 3-day pooled sputum samples are collected for 6 consecutive days from participants by the spontaneous cough technique for cytopathological evaluation. Participants also complete a risk factor questionnaire and undergo a pulmonary function test by spirometry and a blood draw.

Participants complete a questionnaire updating smoking, vital, and lung cancer status and undergo sputum sample collection annually.

Participants are informed of sputum cytology results.

PROJECTED ACCRUAL: A total of 3,400 participants (2,900 with airflow obstruction and 500 without airflow obstruction) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Current or ex-smoker with a lifetime history of cigarette smoking of ≥ 20 pack years, meeting 1 of the following criteria:

  * Airflow obstruction

    * FEV_1 \< 75% predicted for age by spirometry
    * FEV_1/FVC ≤ 75% by spirometry
  * No airflow obstruction
* No history of lung cancer

PATIENT CHARACTERISTICS:

Age

* 25 and over

Performance status

* Not specified

Life expectancy

* More than 5 years

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No cancer within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified
Suturing Techniques for Vesico-urethral Anastomosis

Radical prostatectomy (RP) is the most common curative treatment for prostate cancer (PCa).Vesicourethral anastomosis (VUA) is a crucial step and either a conventional interrupted (IS) or a running (RS) suture is employed during radical prostatectomy (RP). Certainly, both RS and IS have advantages and limitations. The metanalysis revealed that potential advantages for RS compared to IS, especially for short-term outcomes such as catheterization time, extravasation rate, and anastomotic suture time. There were no significant differences for long-term outcomes (continence, incidence of vesicourethral anastomotic stenosis). Generally, the exciting evidence suggests that CS should be preferred over IS. However, this should be followed only if it is technically feasible and appropriate regarding the surgical approach. Both techniques seem to be safe and appropriate for the VUA, and the technique should be chosen based on individual experience and preference.

The investigators hypothesized that RS and IS may have different effects on voiding function and flow rate, even if they do not cause an anastomotic stenosis requiring intervention. Furthermore, there is no existing literature that compares RS and IS in terms of voiding function.This article focuses on one year uroflowmetric voiding parameters, urinary function (UF), and UF related bother function, urinary continence recovery as well as other secondary outcomes, including surgical parameters, perioperative morbidity and oncological outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of clinically localised (pT1-pT2) prostate cancer
* must select the open radical prostatectomy procedure as a treatment option.

Exclusion Criteria:

* History of acute urinary retention
* History of urethral stricture
Risk Factors and Complications Contributing to Mortality in Elderly Patients With Fall-Induced Femoral Fracture

This study aimed to identify the risk factors and complications associated with mortality in elderly patients with femoral fracture after a fall from the ground level.

This retrospective study reviewed data pertaining to elderly patients aged ≥ 65 years who were admitted into a Level I trauma center, between January 1, 2009 and December 31, 2017. Multivariate logistic regression analysis was performed to identify independent effects of univariate predictive variables on the occurrence of mortality.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a fall from ≥1 m as well as those for whom incomplete data were available.

Exclusion Criteria:

* those patients with a fall from ≥1 m
* patients with incompleted data
Study Evaluating IMA-638 in Asthma

The purpose of this study is to evaluate the safety of, and blood drug levels for, single, ascending doses of IMA-638 in mild to moderate asthma subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men and women of non-childbearing potential with mild to moderate asthma as defined by forced expiratory volume in 1 second (FEV1) greater than 70% predicted.
* Well controlled asthma, as exhibited by completion of asthma questionnaire.
* Otherwise healthy, except for asthma.
A Phase I Study of Intrathecal Rituximab in Patients With Lymphomatous Meningitis

The purpose of this study is to define the safety profile of rituximab given intrathecally in lymphomatous meningitis related to CD20+ non-Hodgkin's lymphomas.


Eligibility Criteria:
Inclusion Criteria:

1. Lymphomatous meningitis documented by positive CSF cytology in either newly diagnosed, relapsed or refractory primary CNS or systemic NHL
2. Pathologically diagnosed CD20-positive NHL
3. Age ≥ 18 years
4. ECOG Performance Status 0 - 2 (See Appendix A)
5. Life expectancy of at least 1 month
6. Informed consent must be given according to national/local regulations before enrollment (See Appendix B)
7. Patients may have had prior CNS irradiation, intrathecal methotrexate, cytarabine or thiotepa for treatment of lymphomatous meningitis but these treatments must have completed at least two weeks before the study enrollment and the patients must have recovered from any reversible toxicity caused by prior treatments
8. Concurrent systemic chemotherapy is allowed with the exception of high-dose methotrexate (\>500 mg/m2/day), high-dose cytarabine (\>2 g/m2/day), high-dose thiotepa (\>300 mg/m2/day) or investigational agents
9. No concurrent intrathecal chemotherapy other than rituximab
10. No severe impairment of bone marrow function (ANC \>1.5x109/L, PLT \>50x109/L), unless due to proven lymphoma involvement
11. No major impairment of renal function (serum creatinine \< 1,5 x upper normal) or liver function (ASAT/ALAT \< 2,5 upper normal, total bilirubin \<2,5x upper normal), unless due to proven lymphoma involvement
12. No evidence of active opportunistic infections
13. No HIV infection
14. No pregnant or lactating status
15. Appropriate contraceptive method in women of childbearing potential or men
16. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
17. Absence of a obstructive hydrocephalus or compartimentalization of CSF flow.
The Neuroprotective Effect of Remote Ischemic Conditioning in Aneurysm Coiling Therapy

The overall incidence of DWI positive for thromboembolic events following endovascular treatment of intracranial aneurysms is proximately 50%. Whether remote ischemic conditioning was safe and effective to reduce ischemic brain lesions on DWI after endovascular treatment of intracranial aneurysms is still unclear. The investigators' hypothesis is that remote ischemic conditioning is a safe and effective strategy to reduce new ischemic lesions in intracranial aneurysms patients undergoing endovascular treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Unruptured brain aneurysm deemed suitable for neuroendovascular repair
* Normal baseline brain MRI
* Female subjects of childbearing potential have a negative pregnancy test.
* Signed informed consent prior to entering study

Exclusion Criteria:

* Dissecting or mycotic brain aneurysm.
* Planned endovascular vessel sacrifice as the primary modality for aneurysm treatment
* Severe, sustained hypertension (SBP \> 185 mmHg or DBP \> 110 mmHg)
* Contraindication for remote ischemic conditioning: severe soft tissue injury, fracture, or peripheral vascular disease in the upper limbs
* Pre-morbid modified Rankin scale score of greater than 1
* Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations
* Patients who are unable to have an MRI scan for any reason.
* Currently participating or previously participated in any investigational drug or device study within 6 months
Depression Management at the Workplace

Randomized trials demonstrate that depression management products can improve clinical and organizational outcomes sufficiently for selected employers to realize a return on investment. Rather than usual care marketing which uses voltage-enhanced promises to sell voltage-diminished products, the investigators designed an evidence-based (EB) intervention to encourage employers to purchase a depression management product that offers the type, intensity and duration of care shown to provide clinical and organizational value. In an RCT designed to examine employer benefit purchasing behavior of depression products in 360 employer members of over 20 regional business coalitions, the research team proposes: (a) to compare the impact of evidence-based (EB) to usual care (UC) presentations on employer benefit purchasing behavior, and (b) to identify mediators and organizational moderators of intervention impact on employer benefit purchasing behavior.

This study addresses what policy analysts argue is one of the most pivotal problems in the translation of evidence-based care to 'real world' settings: whether purchasers can be influenced to buy health care products on the basis of value rather than cost. In the likely event that EB \> UC, the study will provide encouragement to use an evidence-based approach to market new health care products to private payers on the basis of the product's clinical and organizational value. UC may achieve comparable outcomes to EB if the limiting factors in benefit purchasing are organizational, purchasing group and vendor constraints that no intervention can meaningfully modify. Support for this scenario would encourage the targeted marketing of new products to coalition members with empirically identified organizational, purchasing group and vendor characteristics, using usual care strategies.


Eligibility Criteria:
Inclusion Criteria:

* Coalitions who belong to the National Business Coalition on Health are eligible if:

  * they have 30+ employer purchasers/affiliates as members
  * they act as more than purchasing agents
  * (3)they did not participate in the research team's preliminary studies on this topic.
* Employers of participating coalitions are eligible if:

  * they are a public or private organization providing health care benefits to 100+ domestic employees
  * they have not purchased a depression management product in the past two years.

Exclusion Criteria:

* None
Home Based Treatment for Drug Use in Early Adolescents

This study will compare two programs to see if they are helpful in preventing the use of substances in adolescents with attention deficit-hyperactivity disorder (ADHD), oppositional defiant disorder (ODD), or conduct disorder (CD). One of the programs involves working with adolescents and their parent(s) in their home. The other program involves working with adolescents and their parent(s) in an office setting.

In this study phase, 36 patients with a disruptive behavior disorder (DBD - i.e., attention deficit-hyperactivity disorder, oppositional defiant disorder, conduct disorder) and use or abuse of one or more substances will be randomly assigned to treatment using either a standard treatment for DBDs in this age group or the newly developed HBT treatment. Treatment outcomes for the 24 patients assigned to receive HBT will then be compared to outcomes for the 12 patients assigned to receive standard DBD treatment.

Specific aims of Phase II include:

1. finalizing the HBT treatment manual and measures of treatment fidelity, therapist competence, and treatment satisfaction;
2. generating estimates of treatment effect sizes for substance use, disruptive behavior, and functional status outcomes, as pilot data for a larger efficacy study, and
3. comparing treatment satisfaction for the two treatment groups.

We hypothesize that HBT will lead to significantly lower rates of disruptive behaviors, substance use, and SUDs than with standard treatment, as well as greater concomitant improvements in impairment.

Eligibility Criteria:
Inclusion Criteria:

* Study participants (subjects and parents) must provide written consent and verbal assent
* Adolescents aged 11 through 14 of any race or ethnic background,
* A DSM-IV disruptive behavior disorder diagnosis (either CD, ODD, ADHD or disruptive behavior disorder not otherwise specified \[DBD NOS\]),
* Adolescents who are either using one or more substances regularly (2 or more times a month for 3 consecutive months), and
* Acceptable insurance coverage (i.e., participant has insurance that is accepted by the University of Pittsburgh Medical Center \[UPMC\] in the event that they are randomly assigned to the treatment-as-usual \[TAU\] group).

Exclusion Criteria:

* Full scale IQ below 80;
* History of pervasive developmental disorder, schizophrenia or other psychotic disorders, organic mental disorders or eating disorders,
* Diagnosis of bipolar disorder,
* Recent treatment for substance problems, and/or
* Daily use of "hard" street drugs (i.e., cocaine, methamphetamine, heroin, inhalants).
Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes

Peripheral blood mononuclear cells (PBMC) and platelets could be interesting ex vivo models to study brain diseases. Indeed, there is no access to neurons from patients. However, PBMC can exhibit different physiopathological mechanisms that are ubiquitous (i.e. oxidative stress, mitochondriopathy with energy metabolism, inflammation, protein folding, iron metabolism and programmed cell death ...). The platelets are pivotal in the healing system with large range of growth factors. A new therapeutic concept of conservative iron chelation with deferiprone for neuroprotection is under development.

The action of deferiprone on the different mechanisms and notably the oxidative stress are to obtain from a collection of PBMC and platelets from patient having Parkinson's disease and Amyotrophic lateral sclerosis and healthy controls to study ex vivo.

PBMC and platelets will be stored for future analyses.

The study collection of PBMC and platelets from 30 patient having Parkinson's disease 30 patients having Amyotrophic lateral sclerosis and 30 healthy controls.

The collection will be performed either by cytapheresis for half of the patient and by collecting the whole blood for the other half.

PBMC and platelets will be stored at minus 80°C. PBMC of patients and controls are exposed ex vivo to different pathological condition (mainly Hydrogen peroxide, menadione, hypoxia...) with and without deferiprone to analyse whether the level of oxidative stress (Reactive Oxygen Species and notably hydroxyl radical with hydroxypethidine probe with flow cytometry) is reduced under deferiprone (primary criterion. Secondary analyses will concern the level of iron, the energy metabolism (aerobic versus anaerobic and the level of Adenosine triphosphate production), the type of cell death (apoptosis, autophagy and new programmed cell death: Ferroptosis) and inflammation. Finally, the level of growth factors and their effectiveness will be studied from platelets.

Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease according to Movement Disorders Society criteria
* Amyotrophic Lateral Sclerosis according to El escorial criteria
* Age and sex matched healthy controls

Exclusion Criteria:

* Severe comorbidities (cancer, other degenerative diseases, hemopathy, inflammatory diseases)
The Normal Standard of Brainstem Auditory Evoked Potential in Adults Using a New Device

There are no differences between the exams made with the new device,that evaluates the hearing, and the device gold standard, that is widely used in clinics and hospitals.


Eligibility Criteria:
Inclusion Criteria:

* hearing thresholds less than 25 dB at all frequencies of pure tone audiometry, with differences between the ears, by frequency, or less than 10 dB.
* The group with bilateral sensorineural hearing loss was made up of adults with hearing thresholds changed from 25 to 60 dB HL for the frequencies 2000-8000 Hz for pure tone audiometry.

Exclusion Criteria:

-