cyrilzakka/clinical-trials huggingface dataset:
Patient Navigator Project

Patient Navigation is a Supportive Care Intervention that addresses barriers to quality standard care by providing individualized assistance to patients and families. The NCI is conducting several research programs to test the effectiveness of this approach. The expected outcomes of patient navigation through the cancer care system include:

* Timely, definitive diagnosis following an abnormal test
* Timely treatment following positive diagnosis
* Patient satisfaction with the diagnostic and care system experience

The goal of our local project is to provide Tampa Bay with a culturally appropriate Patient Navigator Program that will decrease delay in diagnosis and delivery of cancer care in an acceptable and cost-effective manner leading to lower cancer mortality among our underserved populations. We will partner with community health centers in the Tampa Bay area to provide an avenue for patients who have received an abnormal screening for breast and colorectal cancer to easier pilot the course of the healthcare system. The populations served by this program will include African-Americans, Hispanics and rural Whites who are medically underserved due to lack of insurance, documentation issues and a variety of other barriers to health care.

The primary outcome to be tested with this program is the time it takes for patients with an abnormality to receive a definitive diagnosis. Secondary outcomes such as patient satisfaction and cost-effectiveness will also be measured. This program occurs in three phases. In Phase I, the aim is to work closely with our key community partners to conduct formative research for the development of an acceptable, appealing, and appropriate Patient Navigator Program. The aim for Phase II is to conduct a group randomized controlled trial by having participating clinics randomly assigned to an intervention or control clinic. The outcomes from this phase in the project will be assessed through chart reviews, patient satisfaction surveys and other survey methods. In Phase III a comprehensive evaluation on the program will be produced and disseminated nationally.

Eligibility Criteria:
Inclusion Criteria:

* Receive health care at one of the enrolled clinics
* Newly diagnosed with breast of colorectal cancer or if they have an abnormality that is suspicious for breast (breast lump, or abnormal mammogram) or colorectal cancer (abnormal colon screening test, blood in bowel movement).

Exclusion Criteria:

* Persons with previous history of breast or colon cancer will be excluded from the study
Mechanisms of Inflammatory Liver Injury

White blood cells can cause liver damage if they inappropriately accumulate in the liver in large numbers. Such an event can occur if an individual's blood is exposed to endotoxin, a substance released from the cell walls of many species of bacteria. The purpose of this study is to isolate neutrophils, an important white blood cell, from the blood of normal volunteers, and put them in tissue culture with isolated liver cells. The experiments will determine how endotoxin can increase the ability of neutrophils to damage liver cells. All studies supported by this grant will be done with isolated cells in tissue culture. This experimental model will reveal possible mechanisms that can in the future be evaluated in human diseases such as bacterial sepsis.

Neutrophils will be isolated from normal human volunteers and placed in cell culture with isolated hepatocytes or C3A cells (hepatoblastoma cell line that exhibit many characteristics of normal hepatocytes). These experiments will evaluate the mechanisms by which neutrophil adhere to the surface of hepatocytes, and the mechanisms by which the attached neutrophils can damage or kill the hepatocytes. Mechanisms of adhesion will involve understanding of the chemokines released by the hepatocytes that stimulate neutrophil adhesiveness, the cytokines that activate hepatocytes to express chemokines and adhesion molecules, the adhesion receptors on the neutrophil surface that are able to recognize the adhesion molecules on the hepatocyte surface, and the ability of adhesion to enhance and focus cytotoxic chemicals coming from the stimulated neutrophils. In addition, the role endotoxin can play in these sequence of events is being studies, and the specific cytotoxic mechanisms released by the neutrophils are under study. As noted in the brief summary, this grant only supports use of human cells in vitro (i.e., all experiments will be done in tissue culture). The purpose of working with this experimental model is to define what mechanisms should in future experiments be evaluated in patients with endotoxin induced disease.

Eligibility Criteria:
Only blood from normal subjects will be used in the in vitro experiments.
Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Tragus and Tongue Stimulation.

this study wants to analyse the effect of trigeminal stimulation on Heart rate Variability. There are going to be two groups, in the test group it will be administered stimulation of the tongue with TENS, while in the control goup TENS will be administered at tragus level.

This study analyses the effect of trigeminal stimulation with TENS on Heart rate variability (HRV). A new intraoral device will be administered on the dorsal surface of the tongue for TENS stimulation in the test group. The RMSSD, LF, HF and LF/HF will be monitered by photoplethysmographic wave. the results obtained with tongue stimulation will be compared with the results obtained in the control group, where it will be administered TENS stimulation at the tragus level. This work sought to assess whether there is a difference in HRV in relation to the site of application of dental ULFTENS (tragus vs tongue).

If effective in reducing the activity of arousal circuits, this tongue-level stimulation technique could have new clinical applications.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Women
* Age 18-30 years

Exclusion Criteria:

* presence of acute and/or chronic cardio-circulatory and respiratory disorders
* metabolic and autonomic system disorders
* intake of excitatory or inhibiting substances of the peripheral and central nervous system
* presence of generalised anxiety and/or panic attacks or mood disorders.
PRETELL: PREvention of TELomere-related Complications After Lung Transplant

To evaluate the safety and efficacy of Danzol in lung transplant recipients with short telomeres.

Subjects with short telomeres recipient of lung transplant, will be randomized in the first month post-transplant to either placebo or Danazol (200mg bid) in a 2:1 ratio.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18
2. Ability to give informed consent
3. Recipient of lung transplantation
4. Short telomeres assessed either pre-transplant or post-transplant with FLOW-FISH as lymphocyte telomere length \<10th percentile predicted for age
5. Clinically stable one month after lung transplant

Exclusion Criteria:

1. Patients on androgen hormones to include testosterone or high dose estrogen (estradiol 0.5 mg/day or greater) during 12 months prior to enrollment
2. Patients with active thrombosis or thromboembolic disease and history of such events unless thrombosis is line related.
3. Undiagnosed abnormal genital bleeding, porphyria, androgen-dependent tumor, or prostatic hypertrophy
4. Patients with active hepatitis B or C
5. Patients who have received a bone marrow transplant
6. Clinically unstable after lung transplantation
7. Current pregnancy, or unwillingness to take be on two forms of contraceptives including a barrier method of birth control or practice abstinence to refrain from pregnancy if of childbearing potential during the course of the study
8. Lactating women, due to the potentially harmful effects on the nursing child
9. Patients with abnormal liver function AST, ALT \>3 times normal
10. Subjects with a history of benign intracranial hypertension
11. Subjects with a history of liver disease not limited to alcoholic hepatitis/cirrhosis, non-alcoholic steatohepatitis (NASH), autoimmune hepatitis (AIH), primary biliary cirrhosis (PBC), and/or history of hepatic adenoma.
12. Subjects with poorly controlled or uncontrolled Type I or II diabetes mellitus
13. Significant renal abnormalities GFR\< 40 ml/min/m2
14. Significant cardiac dysfunction with ejection fraction less than 50%
15. Moribund status such as death is expected in the coming year
16. Currently taking carbamazepine, pimozide or lomitapide
17. Inability to understand the investigational nature of the study or to give informed consent
Physical Activity in Patients With Gynecological Surgery

Examine whether the measurement and feedback of physical activity increase the physical activity in women who underwent midline incision, gynecological surgery


Eligibility Criteria:
Inclusion Criteria:

* Midline incision, gynecological surgery

Exclusion Criteria:

* Cannot ambulate
* Anticipated long term ICU care
* Cannot wear accelerometer
* Anticipated discharge before postoperative day 5
Sentinel Lymph Node Biopsy in Clinically Node-negative Early Breast Cancer Patients After Neoadjuvant Chemotherapy

This is a prospective, single-center, non-randomized, non-controlled observational study.

The panel of the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017 strongly believed that sentinel lymph node biopsy to be appropriate and favored the biopsy be carried out after neoadjuvant treatment in patients who presented with a clinically negative axilla and who received neoadjuvant treatment.

Patients with clinically node-negative early breast cancer treated in Breast Cancer Prevention and Treatment Center Peking University Cancer Hospital from February 2013 to August 2017 were retrospectively analyzed to investigate whether sentinel lymph node (SLN) biopsy after neoadjuvant chemotherapy can reduce the positive rate of SLN and the rate of axillary lymph node dissection (ALND). The study group underwent SLN biopsy after neoadjuvant chemotherapy, and the control group underwent SLN biopsy before chemotherapy. A total of 395 patients were eligible, including 85 in the study group and 310 in the control group. The detection rate of SLNs was 95.3% vs 98.7%（χ2 = 3.922，P = 0.069） in the study group compared with the control group, the positive rate of SLNs was 1.2% vs 18.6%（χ2 = 15.207，P = 0.000）, and the rate of ALND was 5.9% vs 15.2%（χ2 = 5.024，P = 0.025） in univariate analysis. Multivariate analysis showed that the study group had lower SLN positive rate (OR = 0.052, 95% CI: 0.0070 to 0.38, P = 0.004) and ALND rate (OR = 0.310, 95% CI: 0.118 to 0.812, P = 0.017). There was no statistically significant difference in detection rate of SLNs （OR = 0.244, 95% CI: 0.058 to 1.021, P = 0.053）between the two groups.

The aim of this study is to explore the detection rate and positive rate of sentinel lymph nodes, the rate of axillary lymph node dissection, and the proportion of patients with axillary lymph node metastases after neoadjuvant chemotherapy in patients with clinically node-negative early breast cancer. A mathematical model of axillary lymph node status will be established to predict axillary lymph node metastases.

Eligibility Criteria:
Inclusion Criteria:

* Invasive breast cancer diagnosed with core needle needle biopsy;
* Staging cT1b-2N0M0;
* ER/PR positive cells ratio \<10%, or HER2 positive (according to ASCO-CAP guidelines),and with chemotherapy indications;
* Without chemotherapy contraindications, and planned or has started neoadjuvant chemotherapy (HER2 positive breast cancer neoadjuvant anti-HER2 treatment, or have adjuvant anti-HER2 treatment plan);
* With axillary sentinel lymph node biopsy indications confirmed prior to neoadjuvant therapy;
* Voluntarily join the study and sign an informed consent form.

Exclusion Criteria:

* History of malignant tumors.
* With chemotherapy contraindications.
* Recieved any form of surgery of primary tumor or axillary lymph nodes.
* Refuse neoadjuvant chemotherapy.
* Refuse assessment examinations.
* Refuse to join the study.
EURopean Study on Encephalitis in Intensive CAre

Prospective observational multicenter study in European ICUs. All patients admitted to the ICU for probable or confirmed Acute encephalitis (2013 IDSA - Infectious Disease Society of America criteria) will be included. Factors associated with a poor prognosis will be identified by multivariate analysis using a logistic regression.

Primary objective :

evaluate the correlation between mRs score and the baseline characteristics Functional outcomes will be evaluated using the modified Rankin score (mRS) score, which is one of the most frequently used scores in acute neurological diseases \[18\]. A poor outcome will be defined by a mRS score \> 2 (functional dependence or death). The investigator usually evaluates this score if the patient is still in the hospital 90 days after admission. Patients discharged from hospital within 90 days following ICU admission without major disability (mRS 0, 1 or 2) are considered to have a good outcome. Patients discharged within 90 days with a disability will be classified for the study according to the latest available data. Patients will not be contacted directly by the investigator for the study purposes.

Secondary objectives :

To identify additional prognosis factors : the clinical, radiological, biological and neurophysiological factors associated with poor outcome for patients admitted to the ICU with AE

* Day 28 mortality, in-ICU mortality, in-hospital mortality
* Major systemic complications (septic shock, hyponatremia, nosocomial pneumonia, catheter-related BSI, overt gastroenteral bleeding, pulmonary embolism)
* Major intracranial complications during ICU stay

  * Status epilepticus
  * Brain death
  * Empyema/cerebral abscess
  * Cerebral ischemia
  * Intracranial bleeding
* ICP monitoring
* Neurosurgery

The cause of death will be categorized into 2 categories:

* Systemic causes (cardiovascular failure, MOF)
* Neurological cause (Diffuse neurologic injury or withdrawal of care)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* non-opposition to participate in the study (or consent if applicable according to local legislation)
* Impaired consciousness (altered mentation, stupor, or personality changes) for a duration ≥ 24 h, without obvious explanation
* A score on the Glasgow Coma Scale \< or =13 at ICU admission
* A Cerebrospinal fluid pleocytosis \> = 5 cell / mm3
* At least 2 of the following :

  * Fever (≥ 38.0 °C) within 72 hours before or after admission
  * Generalized or partial seizures non-attributable to pre-existing epilepsy
  * New onset focal neurological deficit
  * Parenchymal abnormalities on MRI compatible with AE
  * EEG alterations compatible with AE.

Exclusion Criteria:

* CSF or neuroimaging not available (s) or not performed.
* febrile encephalopathy associated with another diagnosis (sepsis, neurological disease with aspiration pneumonia ... )
Comparing Patient Satisfaction of the Abdomen After DIEAP Procedure and Conventional Abdominoplasty

The purpose of this study was to specifically compare the long term patient satisfaction of the abdomen after DIEAP flap procedure with conventional abdominoplasty.

34 patients reconstructed with a DIEAP flap (DIEAP group) and 30 patients who had undergone a conventional abdominoplasty (AP group) were asked to complete two study-specific questionnaires. One questionnaire covered general and specific aspects concerning abdominal outcomes and morbidity. The other covered general outcomes such as satisfaction with surgery and change of body image, self-confidence, social and intimate relations. In addition, all patients performed an abdominal muscle function test.

Eligibility Criteria:
Inclusion Criteria:

* unilateral DIEAP flap, abdominoplasty

Exclusion Criteria:

* bilateral DIEAP flap, progressive cancer disease
3-week Study to Evaluate Efficacy and Safety of Ziprasidone With Either Lithium or Divalproex in Acutely Manic Subjects

3-week study to evaluate efficacy and safety of ziprasidone with either lithium or divalproex in acutely manic subjects


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a primary diagnosis of Bipolar I Disorder, most recent episode manic (296.4x), or mixed (296.6x) as defined in Diagnostic and Statistical Manual of Mental Disorders - Text Revision (DSM-IV TR) and determined by the Mini International Neuropsychiatric Interview (MINI).
* At screening and at baseline (within 12 hours prior to the first dose of double-blind medication) subjects must have a Young Mania Rating Scale score of 18 or higher.
* Subjects must be actively receiving lithium or divalproex for their bipolar disorder in order to be considered for this study.

Exclusion Criteria:

* Subjects with a Diagnostic and Statistical Manual of Mental Disorders IV- Text Revision (DSM-IV TR) diagnosis of schizophrenia (295.XX), schizoaffective disorder (295.70), schizophreniform disorder (295.40), delusional disorder (297.1), or psychotic disorder not otherwise specified (NOS) (298.9).
* Subjects with other DSM-IV-TR Axis I or Axis II disorders (in addition to Bipolar I disorder) are ineligible if the comorbid condition is clinically unstable, requires treatment, or has been a primary focus of treatment within the 6-month period prior to screening.
Endoscopic Tympanoplasty: Single Versus Double Flap Technique

Aim of this study is to compare results of double and single flap techniques for tympanoplasty in chronic suppurative otitis media patients. Inclusion criteria include total or subtotal tympanic membrane perforations with limited anterior remnant and should be dry for at least 3 months. Patients with persistent discharge, cholesteatoma, ossicular affection or those with recurrent perforations after previous myringoplasty were excluded. Also, patients with uncontrolled diabetes, chronic liver and kidney diseases and immuno-compromised patients are not included in this study. Patients are divided into two groups, endoscopic double flap group and endoscopic single flap group. Healing and hearing outcomes were evaluated 3 months postoperative. Also, post-operative pain scores and complications were assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic suppurative otitis media with total or subtotal tympanic membrane perforation with limited anterior remnant.
* dry perforation for at least 3 months.

Exclusion Criteria:

* Recurrent perforation after previous myringoplasty.
* Ossicular disruption or fixation.
* immune-compromised patients including uncontrolled diabetics, chronic liver and kidney diseases.
Effects of Kinesiology Taping in Stroke Patients

The goal of this clinical trial is to learn if kinesiology taping works to treat stroke patients. The main question it aims to answer is:

Is kinesiology taping effective in stroke patients? Researchers compare kinesiology taping to a placebo (visually similar but has no effects) to see if kinesiology taping works immediately to treat stroke patients.

This study aimed to evaluate the immediate effects of kinesiology taping (KT) on trunk control, posture, proprioception, and upper limb function in stroke patients, specifically focusing on the trunk-scapula-shoulder complex. A total of thirty-seven stroke patients participated in this placebo-controlled trial, where they were randomly assigned to either the KT group (n=19) or a placebo-controlled sham KT group (n=18). The KT group received kinesiology taping applied using facilitation and inhibition techniques, while the control group received sham taping without therapeutic tension.

The application of kinesiology taping to the trunk-scapula-shoulder complex in stroke patients resulted in immediate enhancements in trunk control, shoulder posture, and proprioception. However, it did not significantly improve upper limb function in the short term.

Eligibility Criteria:
Inclusion Criteria:

* Experienced a first-ever stroke
* Demonstrated a motor recovery level of Brunnstrom stages 3 or 4 in the affected upper limb
* No history of botulinum toxin-A therapy within the past three months
* Possess sufficient cognitive ability to understand and follow assessment instructions

Exclusion Criteria:

* Individuals with movement or functional limitations due to prior shoulder injuries
* Exhibited allergic reactions or skin sensitivities to taping
* Patients with any existing skin conditions
Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

This study will examine the effect of external beam radiation therapy in the prevention of restenosis following successful balloon aortic valvuloplasty in severe, symptomatic aortic stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Severe Aortic Stenosis
* NYHA Class 2-4 CHF Symptoms
* Age \> 75
* EuroSCORE \> 7
* Prohibitively High Risk for Aortic Valve Replacement Surgery as Designated by a Cardiac Surgeon
Combination of Stereotactic Radiosurgery and Enhanced Immunotherapy for Recurrent Glioblastomas(inSituVac2)(CSREIG)

The study will investigate combined stereotactic radiosurgery and enhanced immunotherapy for recurrent glioblastomas. Immune adjuvants will be injected intratumorally and systemically to induce antitumor-specific immunity after radiation induced immunological tumor cell death (ICD). With radiation, tumor cells release tumor antigens that are captured by antigen presenting dendritic cells. Immune adjuvants promote the presentation of tumor antigens and the priming of antitumor T lymphocytes. The combined treatment induces and amplifies the specific antitumor immunity in patients with recurrent glioblastomas, prolonging survivals of patients.

Recurrent glioblatoma (rGBM) is an aggressive malignancy with a poor prognosis. There is no standard therapy and survival is less than 9 months. Recently, personalized cancer immunotherapy has shown great promise in treating different types of cancers. However, effective immunotherapies for rGBMs have yet to be established. The last clinical trial (inSituVac1) showed promised results and this study was based on it. We will investigate whether combining stereotactic radiosurgery with intratumoral and systemic administration of enhanced immune adjuvants will improve the treatment outcome of rGBMs. We will use several immune adjuvants that activate innate and adaptive immunity.

Eligibility Criteria:
Inclusion Criteria:

* 1. Histopathologically confirmed rGBM
* 2. Age18-65
* 3. Participants had undergone maximal surgical resection
* 4. Amount of dexamethasone was not more than 2mg/ days
* 5. Ability and willingness to sign informed consent
* 6. Karnofsky Performance Score of 70 or more
* 7. Normal liver and kidney function
* 8. Not accepted other treatment plan during the immunotherapy

Exclusion Criteria:

* 1. Not conforming to the standard
* 2. Systemic illness or medical condition may pose additional risk,including cardiac, incompensated renal or liver function abnormalities;inflammatory and immune system diseases of rheumatic arthritis
* 3. Received other drugs for glioma therapy 60 days before participated
* 4. Allergy to immune adjuvant
* 5. Nervous system disease and diffuse leptomeningeal disease
* 6. Amount of dexamethasone was more than 2mg/days during the immunotherapy
* 7. Pregnant or lactation