cyrilzakka/clinical-trials huggingface dataset:
Ispinesib In Combination With Carboplatin In Patients With Solid Tumors

The purpose of this study is to determine the dose regimen of Ispinesib in combination with carboplatin in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion and carboplatin is dosed by 30 minute intravenous infusion every 3 weeks (on the same day). A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.


Eligibility Criteria:
Inclusion criteria:

* Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
* ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.

Exclusion criteria:

* Females who are pregnant or nursing.
* Pre-existing hemolytic anemia.
* Pre-existing peripheral neuropathy greater than or equal grade 2. Greater than or equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy, except breast cancer subjects who may have received more than 4 prior chemotherapy regimens.
* Absolute neutrophil count less than 1,500/mm3.
* Platelets less than 100,000/mm3.
* Hemoglobin less than 9 g/dL.
* Total bilirubin greater than1.5 mg/dL.
* AST/ALT greater than 2.5 X upper limit of normal.
* Creatinine clearance less than or equal to 50 mL/min (calculated by the Cockcroft Gault Formula).
* Known contra-indications to the use of carboplatin, cisplatin, or other platinum-containing compounds.
Medicaid Disenrollment: Intrastate Emergency Department Impact

We will obtain data from the robust Agency for Healthcare Reimbursement and Quality (AHRQ) Healthcare Utilization Project (HCUP), as well as from the State of Tennessee. If our hypotheses are true, such data will provide strong evidence that Medicaid disenrollment has a negetive health impact on uninsured populations. The data may also provide evidence for increased public funding of safety-net EDs after Medicaid disenrollment.


Eligibility Criteria:
Inclusion Criteria:

* data will be obtained from the Agency for Healthcare Reimbursement and Quality (AHRQ) Healthcare Utilization Project (HCUP)

Exclusion Criteria:

* n/a
Efficacy of Post-radiation Adjuvant Temozolomide Chemotherapy in Residue Low-grade Glioma

Low-grade glioma (LGG) is a common primary brain tumor in young adults. The infiltrative nature and frequent growth in eloquent area in brain often makes total resection impossible. Until now, no agreement has been achieved on the treatment of LGG without total resection. Post-radiation adjuvant temozolomide (TMZ) is currently the standard of care for high-grade gliomas. Radiotherapy or TMZ is recommended for the treatment of residue low-grade gliomas. However, the efficacy of combined radiotherapy with adjuvant TMZ for residue LGG remains to be defined. In this randomized controlled trial, the investigators will test the hypothesis that radiotherapy with subsequent TMZ chemotherapy is superior to improve the progression-free survival of patients with residue LGG without significant impairment to quality of life compared to radiotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18 years to 60 years
* Incompletely resected supratentorial WHO II astrocytoma, oligodendroglioma or oligodendroastrocytoma
* Karnofsky Performance Score ≥ 60
* Adequate bone marrow, liver and renal function
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent

Exclusion Criteria:

* Refusal to participate the study
* Known hypersensitivity or contraindication to temozolomide
* Previous irradiation, prior radiosurgery or prior chemotherapy
* Pregnant or lactating females
* Malignant tumor other than brain tumor
* Contraindicated for MRI examination
* Unable to comply with the follow-up studies of this trial
Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65

The purpose of this study is to find out if by giving a combination of 3 drugs the leukemia will go into complete remission (meaning the leukemia is completely gone), and to find out how long it stays away. The drugs used in this project are FDA approved and commercially available.

The majority of new cases of acute myeloid leukemia (AML) are diagnosed in patients older than 65 years of age. The median age of patients at time of diagnosis is 67 years. Standard therapies for AML often have significant toxicity and are poorly tolerated by this patient population. Treatment strategies for elderly patients with AML are limited. In those patients who do achieve complete remission, duration of remission tends to be short. Treatment at time of relapse is exceedingly difficult and outcomes are dismal. Thus, there is need for safer and more effective therapies for elderly patients with AML. This trial is a novel therapeutic combination of deferasirox (Exjade), cholecalciferol, and azacitidine in patients 65 years or older with newly diagnosed AML who are not fit for standard induction chemotherapy or hematopoietic stem-cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

* 65 or older (must have reached 65th birthday)
* Morphologically confirmed diagnosis of AML, excluding AML-M3
* Must have a Zubrod performance status of 0-3

Exclusion Criteria:

* Patients with known HIV infection are excluded. If HIV infection is suspected based on clinical condition, testing may be performed at the discretion of treatment team, but is not mandated prior to enrollment.
* Patients with central nervous system involvement by AML are excluded
* Patients with history of an active cancer (except basal cell and squamous cell cancers of the skin) within the previous 2 years are excluded
Pulmonary Hypertension on Prognosis of Acute Myocardial Infarction Patients With Reduced Left Ventricular Function

Pulmonary hypertension (PH) has a negative effect on acute myocardial infarction (AMI) patients and appears to be closely associated with reduced left ventricular function. However, its impact on AMI patients with reduced left ventricular function remains unclear. This retrospective study included AMI patients with reduced left ventricular function to investigate the prognostic value of PH in this specific type of patient. Meanwhile, a nomogram would be established basing on the identified independent risk factors, hoping to provide a novel risk stratification for them.


Eligibility Criteria:
Inclusion Criteria:

* The patients who were hospitalized for AMI with reduced left ventricular function at the First Affiliated Hospital of Jiaotong University from January 2018 to January 2022.

Exclusion Criteria:

* Myocardial infarction complicated by cardiac rupture.
* Significant pre-existing heart failure.
* Other comorbidities such as malignancy that may significantly affect prognosis.
* Incomplete clinical data.
Efficacy and Safety of a New Oral Rehydration Solution (Hipp ORS 200 Apple) in Children With Acute Gastroenteritis

It is generally recommended that oral rehydration should be used as first-line therapy to treat or prevent dehydration in children with acute gastroenteritis (AGE). Refusal to drink regular Oral Rehydration Solution (ORS) interfere with compliance with the recommended treatment.

The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) of improved palatability with regular ORS recommended by ESPGHAN in children with acute gastroenteritis (AGE).

It is generally recommended that oral rehydration should be used as first-line therapy to treat or prevent dehydration in children with acute gastroenteritis (AGE). Despite the proven efficacy of oral rehydration therapy it remains underused. The main reason for this is that an ORS neither reduces the frequency of bowel movements and fluid loss nor shortens the duration of illness, which decreases its acceptance. Moreover, unpalatability of regular ORS decrease its acceptance, especially in children with lower degrees of dehydration. Refusal to drink regular ORS interfere with compliance with the recommended treatment. Parents, but also health care professionals, demand safe, effective, inexpensive, but also well tolerated and accepted ORS for management of AGE.

Recently, a new ORS (Hipp ORS 200 Apple) with improved taste has been developed, and is now frequently employed for the management of AGE. The proposed study will be the first double-blind randomized trial of this ORS. It will evaluate clinically meaningful benefits to be derived by children and caregivers from its use. If positive, this new ORS may become a routine recommendation for children with AGE.

The objective of this study is to compare the tolerance, acceptance, efficacy and safety of a new ORS (Hipp ORS 200 Apple) with regular ORS recommended by ESPGHAN in children with AGE.

Eligibility Criteria:
Inclusion Criteria:

* children age 4 to 48 months
* diarrhoea defined as the passage of three or more loose or watery stools per day for \>1 but \<5 days
* mild (3%) or moderate dehydration (3-9%) according to the World Health Organization criteria (Table 1)
* informed consent signed by at least one parent / caregiver

Exclusion Criteria:

* diarrhea for \<1 or \>5 days
* severe dehydration (\>9%)
* recent history of diarrhea indicated either by parent/guardian or hospital case notes
* underlying chronic gastrointestinal disease (i.e., celiac disease, cow's milk protein intolerance)
* breastfeeding \>50%
* under nutrition (weight/height ratio below the fifth percentile)
* systemic infections
* immune defects or immunosuppressive treatment
A Long Term Follow up Study of Patients Who Have Complete Clearance of Their Actinic Keratosis (AK) Lesions at the Day 57 Visit in the PEP005-028 Study

This study is designed to follow up patients, who have participated in the PEP005-028 study and observed complete clearance of their Actinic Keratosis (AK) lesions, over a 12 month period to assess both recurrence of AK lesions and long term safety in the selected treatment area.


Eligibility Criteria:
Inclusion

* Patient has provided informed consent documented by signing the Informed Consent Form (ICF) prior to any study-related procedures
* Patient achieved complete clearance of AK lesions (lesion count of 0) in the selected treatment area at the Day 57 visit in the following Peplin AK clinical Study: PEP005-028

Exclusion

* Concurrent participation in another research study which would involve the selected treatment area (except for any post-study follow-up visits for previous Peplin AK study)
* Early termination from study PEP005-028
Comparison Of Effectiveness of Transrectal Ultrasonography-Guided Saturation Biopsy And 10-12 Core Biopsy In Repeated Prostate Biopsies

OBJECTIVE To assessment the results of repeated saturation and 10-12 core biopsy protocols in patients with a negative initial biopsy but continued suspicion for prostate cancer MATERIALS AND METHOD Data of the patients who underwent prostate biopsy between June 2007 and June 2012 were retrospectively assessed. Patients with an abnormal digital examination findings and/or abnormal serum prostate specific antigen levels were biopsied. The indication for a repeated biopsy was determined as the continued suspicion for a malignancy after the initial benign biopsy result and/or a pathology result consistent with a high-grade prostatic intraepithelial neoplasia or atypical small acinar proliferation. Patients who underwent saturation and core 10-12 biopsies at repeated biopsies were compared. Statistical analyses were performed with Shapiro-Wilk test and Mann- Whitney U test. A p value less than 0.05 was accepted as statistically significant.


Eligibility Criteria:
Inclusion Criteria:

1. Abnormal digital examination
2. High serum prostate specific antigen (PSA) level.
3. The continued suspicion for a malignancy after the initial benign biopsy result and/or a pathology result consistent with a high-grade prostatic intraepithelial neoplasia (HGPIN) or atypical small acinar proliferation (ASAP).

Exclusion Criteria:

1. Patients with coagulopathies
2. Patients with unsuitable general conditions for prostate biopsy.
Viennese Registry on Patients With Chronic Critical Limb Ischemia

The rationale of this study is to establish a registry to detect and follow patients with CLI treated in Vienna. The Vienna CLI registry is meant to document the incidence, prevalence, and actual outcome of CLI patients in a real world setting and should serve as a tool for the evaluation of medical, endovascular and surgical interventions. It will help determining the prognosis of individual patients and have impact on economic and political decisions in Vienna concerning this disease and the related costs.

This is a prospective observational cohort study including consecutive patients with CLI. The study will be initiated as a single center evaluation and is intended to be step-wise expanded to a Vienna-wide systematic survey. The study will include patients with chronic critical limb ischemia and ischemic ulcerations as defined by Fontaine stage IV or Rutherford stages 5 \& 6. The study will include all patients presenting with CLI to the participating centers including inpatients and outpatients.

Patients will be followed up 1 month, 3 months, 6 months, 12 months and then every 6 months. The study will be continued at least until the 5 year data of the last included patient are available.

Eligibility Criteria:
Inclusion Criteria:

* Chronic (\> 2 weeks) critical limb ischemia in one or both of the lower extremities with necrosis and/or gangrene in the limb (peripheral artery disease IV according to Fontaine's classification or Rutherford stage 5 \& 6) of whatever genesis (atherosclerotic, aneurysmatic, embolic, inflammatory)
* ankle/brachial index \< 0.4 or toe pressure \< 30 mmHg
* Ability to give written informed consent

Exclusion Criteria:

* o Ulceration exclusively due to nonvascular causes like neuropathy (without coexisting hemodynamic impairment as defined above) or venous ulceration (without coexisting arterial impairment as defined above)
Total Laparoscopic Versus Open Aortic Surgery for Abdominal Aortic Disease

This prospective study was designed to analyse the postoperative and long-term outcomes of total laparoscopic vs. open surgical repair of infra-renal abdominal aortic occlusive disease (AOD) and infra-renal aortic aneurysmal disease (AAA) in comparable groups of patients using a propensity analysis model.

From January 2006 to January 2010, 228 consecutive patients who received an aortic bypass for AAA (n=139) or for AOD (n=89) were studied. Open repair was performed in145 patients (AAA=109, AOD=36) and total laparoscopic repair in 83 patients (AAA=30, AOD=53). One-to-one propensity score matching between study groups was done according to a difference in the logit of propensity score of less than 0.04 between each patient pairs in the study groups. Logistic regression with the help of backward selection was used to adjust the effect of treatment method for propensity score as well as other variables in evaluating postoperative and long-term outcome. A p value \< .05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* Aortic occlusive disease (TASC C \& D)
* Aortic abdominal aneurysm with a diameter \> 5 cm

Exclusion Criteria:

* Patients with an occlusive disease amenable to stenting (TASC A \& B)
* Patients with an abdominal aortic aneurysm with an anatomy allowing the use of a stent graft (EVAR)
* Patients with a life expectancy \< 3 years or ASA 4 with a high operative risk
Comparing ESWT Doses for Post-Stroke Ankle Spasticity Treatment

Post-stroke spasticity is a common complication affecting the neurological recovery, self-care daily activities and patients' quality of life. Extracorporeal shock waves (ESWT) have been proven therapeutic effects on decreasing spasticity and regaining function. Stroke patients often suffer ankle plantar flexor spasticity with poor ankle movement control, leading to abnormal gait patterns and risk of falling; local pain appears as well in the ankle. Research showed application of ESWT to lower extremity spasticity reduced ankle plantar flexor spasticity, ankle pain and increased the range of ankle motion. However, the current study did not investigate the effect of ESWT on different muscles in patients with post-stroke ankle spasticity. Therefore, this study will compare the effect of focused ESWT on combination of the gastrocnemius and soleus muscles to gastrocnemius muscle alone in the post-stroke ankle plantar flexor spasticity.

This study design was a single-blind randomized controlled trial and planned to recruit 40 chronic stroke patients with ankle plantar flexor spasticity. The patients were randomly assigned to two groups. The experimental group received focused ESWT to gastrocnemius and soleus muscles (a total of 4000 shots per session), while the control group received focused ESWT to gastrocnemius muscle (2000 shots per session). Patients in both groups underwent a total of 4 sessions ESWT, twice a week for two consecutive weeks. The primary outcome was modified Ashworth scale; the secondary outcomes were modified Tardieu scale, passive range of ankle motions and timed up and go test, and strain elastography. The outcomes were assessed before ESWT and after ESWT at 1, 4, 12, and 24 week.

Eligibility Criteria:
Inclusion Criteria:

1. Subject with Cerebral stroke and age more 20
2. The degree of spasticity of plantar flexor is more than 1.( grading with the modified Ashworth scale)
3. Stable vital sign

Exclusion Criteria:

1. Recurrent cerebral stroke, traumatic brain injury, brain tumor or other brain related disease.
2. Other central nervous system diseases (SCI, Parkinson's disease), or other musculoskeletal disorders which affect the result of evaluating muscle spasticity.
3. Malignant tumor, coagulation disorder, infection or use of pace which were not suitable for Extracorporeal Shock Wave.
4. Received Extracorporeal Shock Wave or Botulinum injection for plantar flexor spasticity in recent 3 months.
5. Subjects who was unable to complete Extracorporeal Shock Wave or evaluation due to impaired cognition or aphasia.
Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples

The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. The main questions it aims to answer are:

* Does AIM-CBCT for PTSD improve PTSD symptoms?
* Does AIM-CBCT for PTSD improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction?

Participants will participate in a two-day retreat in which they are taught and practice skills to decrease PTSD symptoms and enhance their relationships. Researchers will compare AIM-CBCT for PTSD to the Prevention and Relationship Education Program (PREP) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format.


Eligibility Criteria:
Inclusion Criteria:

* Service member or veteran and a romantic partner willing to participate.
* Couple is married or cohabiting for at least 3 months. Couple can be either different or same sex.
* Service member/veteran diagnosis of PTSD as determined by the CAPS-5.
* Each partner is at least 18 years old.
* Both partners able to speak and read English.

Exclusion Criteria:

* Either partner reports current suicidal ideation severe enough to warrant immediate attention
* Current homicide risk meriting crisis intervention for either partner
* Current and severe alcohol misuse in either partner in the past 12 weeks and/or warranting immediate intervention
* Recent (past month) manic episode or psychotic disorder symptoms in either partner
* Evidence of a moderate or severe traumatic brain injury or other cognitive impairment in either partner
* Couple is separated or have taken steps to dissolve their relationship
* Either partner is currently participating in evidence-based treatment for PTSD (e.g., Prolonged Exposure, Cognitive Processing Therapy, Present-Centered Therapy for PTSD, Eye Movement Desensitization and Reprocessing, Cognitive-Behavioral Conjoint Therapy for PTSD, or Structured Approach Therapy).
* Evidence or admission of severe intimate aggression as indicated by a "yes" endorsement to the one-question Screen for Conflict Question by either partner occurring within the past 6-months.
Clinical Outcomes of Angioplasty Postconditioning

We previously demonstrated that postconditioning by coronary angioplasty can decrease infarct size (as measured by cardiac enzyme release) in patients with ongoing acute myocardial infarction. It is currently unknown whether postconditioning actually decreases or simply delays myocardial cell death during reperfusion. In addition, the long term effects of postconditioning on recovery of myocardial contraction remains elusive. The objective of the present study is to determine whether infarct size reduction by angioplasty postconditioning is maintained at 6 months and whether functional recovery is improved at one year post-infarction.

Randomized, controlled, single-blinded trial comparing postconditioning to control (no intervention). Postconditioning consists of four episodes of one minute inflation followed by one minute deflation of the angioplasty balloon, starting within one minute of reflow after direct stenting of the occluded coronary artery.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, aged more than 18, with suspected first acute myocardial infarction, within 6 hours of the onset of chest pain, with a need for emergency revascularization by angioplasty. Patients must display a fully occluded (TIMI zero flow) culprit coronary artery, absence of visible collaterals and exhibit TIMI flow \>2 after direct stenting by angioplasty.

Exclusion Criteria:

* Cardiac arrest or cardiogenic shock
* occlusion of the circumflex coronary artery