cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Efficacy and Safety of Renexin CR in Patients With Acute Non-cardioembolic Ischemic Stroke

A study to Evaluate the Efficacy and Safety of Renexin CR in patients with Acute Non-cardioembolic Ischemic Stroke


Eligibility Criteria:
Inclusion Criteria:

1) Patients identified as acute non-cardioembolic ischemic stroke on MRI within 72 hours of onset of symptoms of cerebral infarction.

Exclusion Criteria:

1. Patients with active cancer; vascular malformation, abscess, or other major non-ischemic brain disease (e.g., multiple sclerosis).
2. With a modified Rankin Score (mRS) of 3 or higher before onset.
3. Underwent intravenous thrombolytic therapy (intravenous rtPA) or mechanical thrombectomy within 24 hours of the screening visit.
4. History of hypersensitivity to IP or components
5. Not suitable for aspirin administration at the discretion of the investigator
2-Hour Dispensing Evaluation of Samfilcon A Lenses With EPG01 Packaging Solution Compared to Commercially Available B+L Ultra Lenses

The objective of this 2 hour study is to evaluate the clinical performance of samfilcon A lenses with an alternate packaging solution (EPG01) compared to commercially available B+L Ultra lenses.


Eligibility Criteria:
Inclusion Criteria:

1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
3. Have no active ocular disease or allergic conjunctivitis.
4. Not be using any topical ocular medications.
5. Be willing and able to follow instructions.
6. Have signed a statement of informed consent.

Exclusion Criteria:

1. Participating in a conflicting study in the opinion of the Investigator.
2. Considered by the Investigator to not be a suitable candidate for participation.
Predictive Factors of Acute Oral Mucositis Induced by Chemo-radiotherapy for Local Advanced Nasopharyngeal Carcinoma

This is a prospective, observational study to analyze the clinical and dosimetric factors about the radiation oral mucositis caused by radical chemo-radiotherapy for nasopharyngeal carcinoma patients and try to find the indicators for acute radiation oral mucositis.

All patients received 1 - 3 concurrent chemotherapy during the intensity modulated radiotherapy. Before radiotherapy, three types of mouth mucosa are contoured in all treatment plans. Oral mucosa grades are recorded before and during treatment. Dose-volume Histograms are got to analyze the associated factors.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically conformed Initial nasopharyngeal carcinoma
2. Patients can feed through the mouth.
3. ECOG (Eastern Cooperative Oncology Group) : 0-1.
4. No history of chemo-radiotherapy, immuno-therapy or biotherapy.
5. Normal hemodynamic indices before the recruitment (including white blood cell count\>4.0×109/L, neutrophil count\>1.5×109/L, platelet count \>100×109/L, hemoglobin≥90g/l, normal liver/kidney function).
6. Informed consent signed.

Exclusion Criteria:

1. History of malignant tumors.
2. Any severe complications contraindicated chemotherapy or radiotherapy.
3. Medical history of central nervous system, cognitive or psychological diseases;
4. Pregnant or nursing women.
5. Patients with mental disease cannot complete the questionaire.
6. Patients refused the informed consent.
Health Education for Diabetes Mellitus

Through the construction and study of standardized diabetic health education management model. Routine diabetes health education management model was used in control group and standardized diabetes mellitus health education management model was used in intervention group. The changes of diabetic knowledge, self-management ability, quality of life,patient empowerment, HbA1c, and other metabolic indexes were observed.

The aim was to develop a standardized patient education model reflecting the core educational elements recommended by Chinese diabetes society guideline, which could be delivered by nurses to hospitalized diabetes patients, and which could be easily scaled-up and implemented in China tier 3 hospital setting.

Management mode of standardized diabetes mellitus health education in intervention group.The control group carries on the routine diabetes mellitus health education management. In intervention group , All participants received Management mode of standardized diabetes mellitus health education.The standardized patient education included one-week personalized education on diabetes knowledge, diet and excise, glucose monitoring and hypoglycemia self-management and others during the hospitalization period. After discharge, patients were followed through the phone call at 2and 4 weeks. Follow-up of diabetic education outpatients at 12 and 24 weeks after discharge. The education nurse gave recommendations according to patent's problem during the follow-up. Full-time education nurses carry on education according to diabetes mellitus health education path table. In routine, After hospitalization, the responsible nurses interspersed with diabetes health education during the hospitalization. The health education is mainly about the problems observed by the responsible nurses and the problems raised by the patients. The patients were followed up by telephone 2 weeks after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients with World Health Organization(WHO) diagnosis (1999);
* HbA1c ≥ 7.5%;
* history of diabetes \< 2 years;
* age from 18 to 70 years;
* having the ability of autonomous behavior, informed consent and voluntary participation in the study.

Exclusion Criteria:

* type 1 diabetes mellitus, gestational diabetes mellitus and other special types of diabetes;
* severe acute and chronic diseases, severe psychological failure, lung failure, tumor, etc.
* is participating in other researchers.
Study Comparing the PET Scan and MRI in Identifying Breast Malignancies in Women With Breast Abnormalities

This is a study looking at advanced imaging such as PET/CT and MRI to see if they can provide a more accurate assessment of the patient with dense breasts or difficult to interpret mammograms. In addition, the ability to determine whether one or the other is more accurate or whether both together would be appropriate in this clinical situation, may be able to be measured.

The MRI studies are very sensitive for detection of breast histopathology but less specific in differentiating between small low grade malignancies are more benign pathologies. Multifocal pathology can be challenging in determining site(s) for biopsy.

PET scanning is specific in the measurement of metabolic glucose activity of various histopathologies and is accurate in differentiating aggressive from benign pathology in multifocal breast disease. A further drawback of PET is the lack of ability to observe lesions less than 3-4mm in diameter.

In select cases the combination of MR and PET/CT is able to come to a more conclusive diagnosis - specifically with bilateral or multifocal breast disease.


Eligibility Criteria:
Inclusion Criteria:

* Woman who have breast volumes allowing utilization of MRI breast coil
* Patients who are considered, by radiologist reading the mammograms, to have non interpretable or difficult to interpret x-ray studies. These patients may or may not have palpable breast lumps and may and may not have suspicious areas on their x-ray mammograms.

Exclusion Criteria:

* Women of child bearing potential not practicing a medically accepted method of birth control
* Women who are pregnant or breast-feeding
Post Market Clinical Follow-up Study for the Pamira ICD Lead Family

Confirm clinical safety and performance of the Pamira lead to support the regulatory post market strategy in Europe and other regions and validating promotional claims by

* demonstrating clinical safety
* evaluating performance based on sensing and pacing assessment
* collecting additional data of interest to assess other aspects such as the handling and usability


Eligibility Criteria:
Inclusion Criteria:

* Standard indication for ICD or CRT-D therapy according to clinical guidelines
* Planned for de novo implantation of a BIOTRONIK ICD or CRT-D in combination with Pamira
* Ability to understand the nature of the study and willingness to provide written informed consent
* Ability and willingness to perform all follow-up visits at the study site
* Ability and willingness to use the CardioMessenger and acceptance the BIOTRONIK Home Monitoring® concept

Exclusion Criteria:

* Mechanical tricuspid valve prosthesis or a severe tricuspid valve disease
* Known Dexamethasone acetate intolerance
* Cardiac surgical post-implantation procedure planned within 12 months (including interventional procedures like ablation, valve replacement, heart transplant etc.)
* Less than 18 years old
* Pregnant or breast feeding
* Participating in another interventional clinical investigation
* Life-expectancy less than 12 months
Safety and Efficacy of the Percutaneous Intervention Performed With Devices of a Single-brand

The freedom of choice in medicine is based on the physician's ability to treat their patients with the best available therapy. The armamentarium for percutaneous intervention is frequently determined on the basis of subjective criteria and the experience of the interventional cardiologist. The evaluation of devices used in coronary intervention, especially angiography and its clinical outcomes, has rarely been investigated; the exceptions are studies on stents. Therefore, the freedom of choice for the interventional cardiologist has been challenged, especially because of cost restrictions. This way this study aims to assess the safety and efficacy of a device of a single brand in performing percutaneous transluminal coronary angioplasty (guide catheters, guidewires, balloons, and stents) in selected patients.


Eligibility Criteria:
Inclusion Criteria:

The study included both male and female patients for stent implantation referred for angioplasty of coronary arteries with more than 18 years.

Exclusion Criteria:

* chronic total occlusion angioplasty,
* saphenous graft angioplasty,
* bifurcation angioplasty (lateral branch greater than 1.5 mm)
* plans to perform angioplasty on more than one vessel during the same procedure
* and primary angioplasty in acute myocardial infarction
Early Intervention With Fluoxetine in Autism

This study is a pilot study to evaluate the feasibility and safety of conducting a year long, double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance developmental processes in core areas impacted by autism.

Autism, a brain disorder that affects a small percentage of Americans, often results in a lifetime of impaired thinking, feeling, and social functioning. The disorder generally becomes apparent in children by the age of 3. Autism typically affects a person's ability to communicate, form relationships with others, and respond appropriately to the external world. Some people with autism can function at a relatively high level, with speech and intelligence intact. Others have serious cognitive impairments and language delays, and some never speak. This study will assess the safety and effectiveness of treating autistic children with fluoxetine to enhance developmental processes in core areas impacted by autism.

Each participant was randomly assigned to treatment with double-blinded placebo or fluoxetine for 12 months. After initial screening and randomization, participants were assessed every two weeks for approximately the first 3 months, or until the dose of medication is stabilized. After this initial period, they were assessed on a monthly basis. Dosing was flexible as determined by the adverse and beneficial responses to treatment although there was a suggested titration schedule.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism

Exclusion Criteria:

* Diagnosis of Asperger Syndrome, Rett Syndrome, Childhood Disintegrative Disorder, or Pervasive Development Disorder-Not Otherwise Specified
* Informed that treatment with a selective serotonin reuptake inhibitor (SSRI) is medically inadvisable
* Need for ongoing psychotropic medication (except for diphenhydramine, clonidine, or melatonin for sleep)
* Recent use of stimulants within 5 days prior to enrollment
* Ongoing need for or recent use of most psychotropic medications within 14 days of enrollment
* Recent initiation of specialized educational, behavioral, or diet intervention for autism in the month prior to enrollment
Evaluation of the Diagnostic Efficacy and Safety of [123I]NAV5001 as an Imaging Agent to Aid in the Diagnosis of Parkinsonian Syndromes

This is a phase 3, open-label, multiple-center, non-randomized single dose study to assess the safety and efficacy of \[123I\]NAV5001 SPECT imaging in aiding in the differentiaion of parkinsonian syndromes from non-parkinsonian tremor.


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written informed consent before the initiation of any study related procedures and continues to give willing consent for participation
* Age ≥ 40 years
* Have had upper extremity tremor for \< 3 years duration, regardless of presumed diagnosis or etiology
* Have a UPDRS part III score upon entry of ≤ 16

Exclusion Criteria:

* Any clinically significant or unstable physical or psychological illness based on medical history or physical examination at screening, as determined by the investigator
* Structural brain abnormality affecting the entire brain (e.g., normal pressure hydrocephalus) or the striatum (e.g., local tumor or stroke)
* Any clinically significant abnormal laboratory results obtained at screening and as determined by the investigator
* Any clinically significant abnormal electrocardiogram (ECG) results obtained at screening and as determined by the investigator
* Any history of drug, narcotic, or alcohol abuse within 2 years before the date of informed consent, as defined by the Diagnostic and Statistical Manual of the American Psychiatric Association, Fourth Edition, revised (DSM-IV-TR \[American Psychiatric Association, 1994\])
* Positive urine drug screen for opiates, cocaine, or amphetamines at screening
* Positive pregnancy test before imaging
* Participation in an investigational drug or device clinical trial within 30 days before the date of informed consent
* Previous scan with any DAT imaging agent (e.g. \[123I\]NAV5001, Altropane, DaTscan, DOPASCAN)
* Any exposure to radiopharmaceuticals within 30 days before the date of informed consent
* Breast-feeding
* Inability to lie supine for 1 hour
* Any thyroid disease other than adequately treated hypothyroidism
* Known sensitivity or allergy to iodine or iodine containing products
* Treatment within the 30 days before the date of imaging with amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, and sertraline, paroxetine, or citalopram.
Effect of BIO-K+ on Symptoms of Irritable Bowel Syndrome

The purpose of this study is to evaluate the safety and effectiveness of Bio-K+ on symptoms of IBS.

Given the promising clinical results of previous trials of probiotics for IBS symptoms, the objective of this clinical trial is to evaluate the safety and effectiveness of a proprietary probiotic product, Lactobacillus acidophilus CL1285®, Lactobacillus casei LBC80R® and Lactobacillus rhamnosus CLR2® on symptoms of IBS in otherwise healthy adults.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older
2. Subject meets Rome III criteria for IBS (regardless of IBS subtype) as follows:

   * Recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months associated with 2 or more of the following:

     * Improvement with defecation
     * Onset associated with a change in frequency of stool
     * Onset associated with a change in form (appearance) of stool
   * Symptom onset must be at least 6 months prior to diagnosis
3. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
4. Able to understand the nature and purpose of the study including potential risks and side effects
5. Willing to consent to study participation and to comply with study requirements

   * Abdominal pain or discomfort at least 2 days during run-in period associated with 2 or more of the following:

     * Improvement with defecation
     * Onset associated with a change in frequency of stool
     * Onset associated with a change in form (appearance) of stool
   * Completion of all study-related questionnaires

Exclusion Criteria:

1. Diagnosed gastrointestinal disease, e.g. Crohn's disease, ulcer, cancer
2. Prior abdominal surgery that, in the investigator's opinion, may confound study outcomes
3. Any systemic disease that may confound IBS symptoms or compromise subject safety
4. Life expectancy \< 6 months
5. Pregnant female or breastfeeding
6. Lactose intolerance
7. Immunodeficient subjects
8. Uncontrolled psychiatric disorder
9. Current treatment with nasogastric tube, ostomy, or parenteral nutrition
10. Eating disorder
11. Recent (\< 2 weeks) antibiotic administration
12. History of alcohol, drug, or medication abuse
13. Daily consumption of probiotics, fermented milk, and/or yogurt
14. Known allergies to any substance in the study product
15. Participation in another study with any investigational product within 3 months of screening
Fontan Physiology Ventilation Strategy

This study will investigate the different tidal volume (Vt) strategies during a cardiac catheterization procedure to determine whether or not low or high Vt have an impact on cardiac output.

Research question: While maintaining the same minute ventilation/PaCO2, does higher Vt (10 cc/kg)/lower rate vs. lower Vt (6 cc/kg)/higher rate (maintaining consistent PEEP) result in improved cardiac output?

The trial will be a randomized crossover design. The study cohort will be randomized (50/50) to begin with either low Vt or high Vt ventilation. After achieving steady state, initial cardiac output measurements will be made using a measured oxygen consumption (VO2) and the Fick principle, per routine clinical protocol. Following baseline assessment of cardiac output and hemodynamics (which is standard of care for all catheterization procedures), participants will be transitioned to the alternative ventilation modality (high Vt or low Vt). After a 5-minute equilibration period, oxygen saturations and VO2 measurements will be re-acquired, to determine cardiac output and hemodynamics in this second state.

Eligibility Criteria:
Inclusion Criteria:

* Patients of UPMC Children's Hospital of Pittsburgh that have Fontan physiology (single heart ventricle) that are presenting as outpatients to undergo a cardiac catheterization with general endotracheal anesthesia for purpose of diagnosis or interventional cath.
* Parents and/or guardians willing to provide informed consent.

Exclusion Criteria:

* Those unwilling to give consent and those patients who do not have Fontan physiology.
* Any urgent/emergent catheterization procedure will be excluded.
* Any Fontan patient having a cardiac catheterization under monitored anesthesia care (as opposed to general endotracheal anesthesia) will not be eligible.
* Inability to undergo cardiac catheterization.
* Pregnant women will be excluded.
* \< 6 weeks post-op from Fontan completion surgery
* Same hospitalization as Fontan completion surgery
* Intrinsic pulmonary disease which would be anticipated to impact study protocol / findings
* Fontan completion surgery performed at age \> 7 years
CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of CP4071 in treating patients who have locally advanced or metastatic soft tissue sarcoma.

OBJECTIVES:

* Determine the efficacy, in terms of response rate, of CP4071 in patients with previously treated, locally advanced or metastatic soft tissue sarcoma.
* Determine the clinical toxic effects of this drug in these patients.

OUTLINE: Patients receive oral CP4071 daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed soft tissue sarcoma

  * Metastatic or locally advanced
  * Failed at least 1 prior therapy
* Measurable disease outside prior irradiation field
* No CNS metastases

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* SWOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

* Creatinine less than 1.5 times ULN
* Calcium less than ULN
* Potassium normal

Other:

* No other malignancy within the past 5 years except stage I or II cancer in complete remission, carcinoma in situ of the cervix, or basal cell or squamous cell skin cancer
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior biologic response modifier therapy allowed

Chemotherapy:

* No more than 3 prior chemotherapy regimens for advanced, recurrent, or metastatic disease
* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent hormonal therapy for malignancy

Radiotherapy:

* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy

Surgery:

* At least 4 weeks since prior surgery and recovered

Other:

* No other concurrent cardiac glycosides
Peer Support for Post Intensive Care Syndrome Self-Management

A prospective, 2-arm, single-blind, randomized controlled clinical feasibility trial design is planned. Forty CCI survivors will be randomized (1:1) to either the PS-PICS (peer support) intervention or usual care (control) group.

Randomized participants will complete 4 study assessments: 1) baseline data at hospital discharge; 2) baseline data post-hospital discharge and before the start of the weekly peer support intervention; 3) post-intervention at the conclusion of the 90-day weekly peer support intervention; and 4) follow-up at 6-months post-hospital discharge. The weekly peer support intervention will be delivered by a small pool of critical illness survivor peers (mentors) recruited from the study site from previous research. Peer support mentors will be trained in peer support and MI, and will deliver 3 months of weekly MI interventions (phone-based) to CCI survivors randomized to the intervention group. Participants randomized to the usual care group will not receive the weekly peer support/MI intervention but will receive the usual discharge planning services currently provided at hospital discharge. Participants in both groups will be contacted by the research team for 4 telephone-based assessments. The design will allow us to test the feasibility and potential impact of the PS-PICS intervention on social relationship measures, depression and self-management. Data collection and analyses are guided by the Individual and Family Self-Management Theory. The Individual and Family Self-Management Theory illustrates the interaction of the process of self-management with risk and protective factors, and short-term and long-term outcomes.

Eligibility Criteria:
Inclusion Criteria:

* age18 years or older
* ICU length of stay 8 days or longer
* expected to survive hospitalization with a discharge destination to home within 28 days of hospital discharge
* diagnosed with 2 or more chronic conditions.

Exclusion Criteria:

* death prior to hospital discharge
* enrollment in Hospice services at the time of hospital discharge
* non-communicative
* no access to telephone
* incarcerated